WO2020072493A1 - Apparatus, system, and method for a connector of a dressing of a reduced-pressure system - Google Patents
Apparatus, system, and method for a connector of a dressing of a reduced-pressure systemInfo
- Publication number
- WO2020072493A1 WO2020072493A1 PCT/US2019/054067 US2019054067W WO2020072493A1 WO 2020072493 A1 WO2020072493 A1 WO 2020072493A1 US 2019054067 W US2019054067 W US 2019054067W WO 2020072493 A1 WO2020072493 A1 WO 2020072493A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- connector
- pressure
- reduced
- deformable member
- cavity
- Prior art date
Links
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/22—Valves or arrangement of valves
- A61M39/227—Valves actuated by a secondary fluid, e.g. hydraulically or pneumatically actuated valves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
- A61M1/91—Suction aspects of the dressing
- A61M1/912—Connectors between dressing and drainage tube
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
- A61M1/96—Suction control thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
- A61M1/96—Suction control thereof
- A61M1/966—Suction control thereof having a pressure sensor on or near the dressing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M39/0613—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof with means for adjusting the seal opening or pressure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M39/105—Multi-channel connectors or couplings, e.g. for connecting multi-lumen tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
- A61M1/98—Containers specifically adapted for negative pressure wound therapy
- A61M1/982—Containers specifically adapted for negative pressure wound therapy with means for detecting level of collected exudate
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/22—Valves or arrangement of valves
- A61M39/26—Valves closing automatically on disconnecting the line and opening on reconnection thereof
- A61M2039/266—Valves closing automatically on disconnecting the line and opening on reconnection thereof where the valve comprises venting channels, e.g. to insure better connection, to help decreasing the fluid space upon disconnection, or to help the fluid space to remain the same during disconnection
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/27—General characteristics of the apparatus preventing use
- A61M2205/276—General characteristics of the apparatus preventing use preventing unwanted use
Definitions
- aspects of the present disclosure relate generally to a connector, and more specifically, but not by way of limitation, to a connector for a dressing and/or a system for reduced -pressure therapy and related methods.
- Reduced- pressure therapy may provide one or more benefits, including migration of epithelial and subcutaneous tissues, improved blood flow, and/or micro-deformation of tissue at a wound site. These benefits can increase development of granulation tissue and reduce healing times.
- Reduced-pressure therapy is typically provided by a reduced-pressure system including one or more components and/or one or more devices.
- a conventional reduced -pressure system may include a dressing, one or more tubes, a therapy device (e.g., a reduced-pressure source), or a combination thereof, as illustrative, non-limiting examples.
- the dressing may be placed at a tissue site and coupled to the reduced-pressure source via the tube.
- the reduced-pressure source is configured to establish reduced-pressure (e.g., a reduced- pressure environment) at the dressing and the dressing is configured to maintain the reduced- pressure at the tissue site.
- the reduced-pressure system may be configured with one or more features, such as pressure monitoring and/or regulation, one or more safety warnings, etc.
- the dressing and the therapy device may be configured to be coupled via a multi lumen tube in which a primary lumen is configured to provide reduced-pressure and one or more secondary lumens are configured to be used for pressure monitoring.
- the reduced-pressure system may be configured to provide one or more notifications of activation of reduced-pressure, low pressure, monitored pressure, over pressure, etc.
- one or more features may be inadvertently or purposefully bypassed.
- one or more components may be improperly installed or applied, one or more components may be modified, and/or a component may be coupled to a device not designed or approved for use with the component.
- a dressing may be provided with or include a multi-lumen tube affixed to the dressing.
- the multi-lumen tube may have a device connector at an end of the multi-lumen tube that is configured to be coupled to a particular reduced-pressure therapy device that includes pressure monitoring and/or regulation.
- an individual may cut the tube to remove the device connector, slide a piece of tube (e.g., a single lumen tube) over the multi-lumen tube, and connect the single lumen tube to an available reduced-pressure therapy device or to a wall suction port.
- Modifying one or more components and/or bypassing (e.g., circumventing) features of the reduced-pressure system can reduce effectiveness of the treatment, prolong a treatment period, create an excess reduced-pressure condition that may damage healthy tissue, and/or diminish patient reliability and confidence in the treatment, as illustrative, non-limiting examples. Additionally, or alternatively, modifying one or more components (of the reduced- pressure system) and/or bypassing features can create legal liability for a device manufacture, device operator, healthcare providers, and/or a facility or organization responsible for providing the reduced-pressure therapy.
- the connector e.g., a pad
- the connector is configured to be coupled to a reduced-pressure source via a tube, such as a multi lumen tube.
- the connector includes a connector body (e.g., a housing) configured to define at least a portion of a first cavity.
- the connector further includes a conduit coupled to the connector body and a deformable member positioned within the first cavity.
- the connector further includes a cover layer coupled to the connector body, the deformable member, or both.
- the deformable member may be configurable between a first state (e.g., an undeformed state) and a second state (e.g., a deformed state).
- a first state e.g., an undeformed state
- a second state e.g., a deformed state
- the deformable member In the first state (e.g., the undeformed state), the deformable member is configured and/or positioned to enable reduced-pressure to be communicated via the conduit.
- the deformable member When the deformable member is in the second state, the deformable member is configured to cause a flow path through the conduit to be at least partially restricted and/or blocked.
- the deformable member may transition (e.g., constrict) from the first state to the second state, thereby causing a portion of the cover layer to at least partially block an opening of the conduit.
- the multi-lumen tube may include a third lumen that is configured to enable the reduced-pressure system to monitor reduced-pressure at the dressing.
- the cavity and/or the second lumen may be coupled to receive reduced-pressure (e.g., sub-atmospheric pressure).
- reduced-pressure e.g., sub-atmospheric pressure
- an individual may cut the multi-lumen tube and may couple the cut end of the multi-lumen to a reduced-pressure source such that each lumen of the remaining portion of the multi-lumen tube (coupled to the dressing) receives reduced-pressure.
- reduced-pressure is provided to the cavity via the second lumen and, responsive to the reduced-pressure, the deformable member may deform (e.g., constrict) and restrict or block at least a portion of the opening of the conduit.
- reduced-pressure may be provided to the dressing via the third lumen.
- deformation of the deformable member may also restrict or block the flow path of the third lumen.
- the connector e.g., the cavity and the deformable member
- the connector is configured to deter modifications and/or alterations to a reduced-pressure system.
- the deformable member may constrict (e.g., forms) to block one or more conduits/channels of the connector. Blocking one or more conduits/channels of the connector may restrict and/or prohibit a flow path that reduces or limits an amount of reduced-pressure at the tissue site.
- the connector advantageously avoids excess reduced- pressure at the tissue site when the connector is coupled to a reduced power source, such as an unregulated reduced power source. Additionally, the connector beneficially provides an ability to disconnect, reduce, and/or limit the delivery of reduced-pressure to the tissue site when one or more components/features of the reduced therapy system are intentionally or accidentally modified and/or bypassed. Accordingly, effective, efficient, and safe reduced-pressure therapy may be achieved through use of the reduced-therapy system, thereby advancing patient reliability and confidence in the treatment.
- Some embodiments of the present apparatuses comprise: a connector body configured to define at least a portion of a first cavity; a conduit coupled to the connector body; and a deformable member positioned within the first cavity and configured to be transitionable between a first state and a second state, wherein, when the deformable member is in a first state, the deformable member is configured to allow flow through the conduit, and when the deformable member is in the second state, the deformable member is configured to restrict flow through the conduit.
- the deformable member may be coupled to the connector body and/or may be configured to transition from the first state to the second state responsive to reduced-pressure applied to the first cavity.
- the first state comprises an undeformed state
- the second state comprises a deformed state.
- the deformable member may include a porous structure, such as a foam (e.g., an open cell foam).
- the deformable member includes a through hole configured to align with an opening of the conduit when the deformable member is in the first state.
- the first cavity may be configured to be open to an ambient atmospheric pressure when the deformable member is in the first state.
- the deformable member when the deformable member is in the second state, the deformable member may be configured to restrict or prevent flow through the conduit.
- the connector further includes a cover layer, where the first cavity is further defined by the cover layer.
- the cover layer may be coupled to the connector body, the deformable member, or both.
- the connector may further include a port configured to be coupled to a tube that includes one or more lumens.
- the connector body may be coupled to the port.
- the port may be configured to be coupled to a reduced-pressure source via the tube.
- the port is integrally formed with the connector body.
- the connector may further include a spigot coupled to the connector body.
- the spigot may extend at least partially through the port and/or includes at least a portion of the conduit.
- the connector body may be configured to define at least a portion of a second cavity.
- the conduit may be configured to enable fluid communication between the second cavity and a first lumen of the one or more lumens.
- the second cavity may include a cavity aperture at a first end of the connector body and/or the port may extend from a second end of the connector body.
- the connector body may be configured to be coupled to a tissue site via the first end of the connector body and/or may be configured to be coupled to a reduced- pressure source via the second end of the connector body.
- the conduit may include a first opening and a second opening.
- the deformable member may be configured to block (and/or to cause blockage of) at least a portion of the first opening of the conduit to restrict the flow through the conduit.
- the second opening of the conduit may be configured to be positioned within the first lumen of the one or more lumens.
- the connector is configured such that the second cavity includes a cavity aperture at a first end of the connector body and/or the port extends from a second end of the connector body.
- the connector body may be configured to be coupled to a tissue site via the first end of the connector body and to be coupled to a reduced-pressure source via the second end of the connector body.
- the connector may further include a base extending form a peripheral portion of the connector body associated with the cavity aperture (of the second cavity). Additionally, or alternatively, the port may include one or more lumen interfaces. In some such implementations, the connector may further include a channel extending between the second cavity and a lumen interface of the one or more lumen interfaces.
- Some embodiments of the present apparatuses comprise: a connector; and a drape coupled to the connector and configure to be coupled to a tissue site.
- the connector may include a connector as described above with reference to some embodiments of the present apparatuses (e.g., of a connector).
- the connector may comprise a connector body configured to define at least a portion of a first cavity; a conduit coupled to the connector body; and a deformable member positioned within the first cavity and configured in a first state, wherein, when the deformable member is in a second state, the deformable member is configured to restrict a flow through the conduit.
- Some embodiments of the present system comprise: a dressing; and a reduced-pressure source configured to be coupled to a connector via one or more tubes.
- the dressing may include a dressing as described above with reference to some embodiments of the present apparatuses (e.g., of a dressing).
- the dressing may the connector; and a drape coupled to the connector and configured to be coupled to a tissue site.
- the connector may include a connector as described above with reference to some embodiments of the present apparatuses (e.g., of a connector).
- Some embodiments of the present methods comprise: coupling a dressing to a tissue site of a patient; coupling the dressing to a reduced- pressure source via one or more tubes; and providing, by the reduced-pressure source, reduced- pressure at the dressing.
- the dressing may include as described above with reference to some embodiments of the present apparatuses (e.g., of a dressing).
- the present methods further comprises, responsive to reduced-pressure provided to a first cavity of a connector of the dressing, deforming a deformable member positioned in the first cavity.
- Some embodiments of the present methods comprise: receiving reduced-pressure at a cavity of a connector; responsive to the reduced-pressure, deforming a deformable member positioned within the cavity; and blocking, based on the deformable member, at least a portion of an opening of a conduit of the connector.
- the connector may include a connector as described above with reference to some embodiments of the present apparatuses (e.g., of a connector).
- the connector may include a connector body configured to define at least a portion of a first cavity; a conduit coupled to the connector body; and a deformable member positioned within the first cavity and configured in a first state, wherein, when the deformable member is in a second state, the deformable member is configured to restrict a flow through the conduit.
- Some embodiments of the present apparatuses comprise: a connector body configured to define at least a portion of a first cavity; a conduit coupled to the connector body; and a deformable member positioned within the first cavity and configured in a first state, wherein, when the deformable member is in a second state, the deformable member is configured to restrict flow through the conduit.
- the deformable member may be configured to restrict the flow through the conduit as compared to the deformable member configured in the first state.
- the deformable member may be coupled to the connector body and/or may be configured to transition from the first state to the second state responsive to reduced-pressure applied to the first cavity.
- the first state comprises an undeformed state
- the second state comprises a deformed state.
- the deformable member may include a porous structure, such as a foam (e.g., an open cell foam).
- the deformable member includes a through hole configured to align with an opening of the conduit when the deformable member is in the first state.
- Some embodiments of the present apparatuses comprise: a connector body configured to define at least a portion of a first cavity; and a deformable member configured to, responsive to reduced-pressure applied to the first cavity, deform to affect flow through the connector body.
- the present apparatuses further comprise a conduit coupled to the connector body, and where the deformable member is configure to, responsive to reduced-pressure applied to the first cavity, deform to affect flow via the conduit.
- the deformable member is configured to deform to restrict the flow through the connector body.
- the deformable member is configured to deform to prevent the flow through the connector body.
- an ordinal term e.g.,“first,”“second,”“third,” etc.
- an element such as a structure, a component, an operation, etc.
- the term “coupled” is defined as connected, although not necessarily directly, and not necessarily mechanically. Additionally, two items that are“coupled” may be unitary with each other.
- components may be coupled by virtue of physical proximity, being integral to a single structure, or being formed from the same piece of material. Coupling may also include mechanical, thermal, electrical, communicational (e.g., wired or wireless), or chemical coupling (such as a chemical bond) in some contexts.
- the terms“a” and“an” are defined as one or more unless this disclosure explicitly requires otherwise.
- the term“substantially” is defined as largely but not necessarily wholly what is specified (and includes what is specified; e.g., substantially 90 degrees includes 90 degrees and substantially parallel includes parallel), as understood by a person of ordinary skill in the art.
- the term“approximately” may be substituted with“within 10 percent of’ what is specified.
- the term“substantially” may be substituted with“within [a percentage] of’ what is specified, where the percentage includes .1, 1, or 5 percent; or may be understood to mean with a design, manufacture, or measurement tolerance.
- the phrase “and/or” means and or.
- A, B, and/or C includes: A alone, B alone, C alone, a combination of A and B, a combination of A and C, a combination of B and C, or a combination of A, B, and C.
- “and/or” operates as an inclusive or.
- any aspect of any of the systems, methods, and article of manufacture can consist of or consist essentially of - rather than comprise/have/include - any of the described steps, elements, and/or features.
- the term“consisting of’ or“consisting essentially of’ can be substituted for any of the open-ended linking verbs recited above, in order to change the scope of a given claim from what it would otherwise be using the open- ended linking verb.
- the term“wherein” may be used interchangeably with“where.”
- a device or system that is configured in a certain way is configured in at least that way, but it can also be configured in other ways than those specifically described.
- the feature or features of one embodiment may be applied to other embodiments, even though not described or illustrated, unless expressly prohibited by this disclosure or the nature of the embodiments.
- FIG. 1A is a perspective view of an example of a system for wound therapy
- FIG. IB is a cross-sectional view of an example of a tube taken along line A-A of FIG 1A;
- FIG. 2 is a cross-sectional view of an example of a connector
- FIG. 3 is a cross-sectional view of another example of the connector of FIG. 2;
- FIG. 4 is a cross-sectional view of another example of the connector of FIG. 2;
- FIG. 5 is a cross-sectional view of another example of the connector of FIG. 2;
- FIG. 6 is a cross-sectional view of another example of a connector
- FIG. 7 is diagram of an example a system for wound therapy
- FIG. 8 is a flowchart illustrating an example of a method of operation of a connector.
- FIG. 9 is a flowchart illustrating an example of a method of operation of reduced- pressure system.
- tissue site and“target tissue” as used herein can broadly refer to a wound (e.g., open or closed), a tissue disorder, and/or the like located on or within tissue, such as, for example, bone tissue, adipose tissue, muscle tissue, neural tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendons, ligaments, and/or the like.
- tissue site and target tissue as used herein can also refer to a surrounding tissue area(s) and/or areas of tissue that are not necessarily wounded or exhibit a disorder, but include tissue that would benefit from tissue generation and/or tissue that may be harvested and transplanted to another tissue location.
- tissue site and target tissue may also include incisions, such as a surgical incision.
- “target tissue” may correspond or refer to a wound
- “tissue site” may correspond or refer to a tissue area(s) surrounding and including the target tissue.
- wound as used herein can refer to a chronic, subacute, acute, traumatic, and/or dehisced incision, laceration, puncture, avulsion, and/or the like, a partial-thickness and/or full thickness bum, an ulcer (e.g., diabetic, pressure, venous, and/or the like), flap, and/or graft.
- a wound may include chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness bums, ulcers (such as diabetic, pressure, or venous insufficiency ulcers), flaps, grafts, and fistulas, for example.
- the term“reduced-pressure” (or“negative pressure”) as used herein generally refers to a pressure less than a local ambient pressure, such as the ambient pressure in a local environment external to a sealed therapeutic environment (e.g., an internal volume). In most cases, this reduced-pressure will be less than the atmospheric pressure at which the patient is located. Alternatively, the reduced-pressure may be less than a hydrostatic pressure associated with tissue at the tissue site. Unless otherwise indicated, values of pressure stated herein are gauge pressures. References to increases in reduced-pressure typically refer to a decrease in absolute pressure, and decreases in reduced-pressure typically refer to an increase in absolute pressure. Additionally, the process of reducing pressure may be described illustratively herein as“applying”,“delivering,”“distributing,”“generating”, or“providing” reduced-pressure, for example.
- fluid may refer to liquid, gas, air, or a combination thereof.
- fluid seal or“seal,” means a seal adequate to maintain reduced-pressure at a desired site given the particular reduced-pressure source or subsystem involved.
- downstream typically implies something in a fluid path relatively closer to a reduced-pressure source, and conversely, the term“upstream” implies something relatively further away from a reduced- pressure source.
- upstream implies something relatively further away from a reduced- pressure source.
- the fluid path may also be reversed in some applications (such as by substituting a positive-pressure source for a reduced-pressure source) and this descriptive convention should not be construed as a limiting convention.
- FIG. 1A shows a perspective view of an illustrative system 100 (e.g., a reduced- pressure system) for reduced-pressure therapy using reduced-pressure.
- System 100 e.g., a reduced-pressure therapy system
- System 100 is configured to provide reduced-pressure at a tissue site 120 associated with a target area of a patient.
- dressing 116 may be in fluid communication with tissue site 120 and may be in fluid communication with therapy device 110 via tube 114.
- system 100 may include one or more components commercially available through and/or from KCI USA, Inc. of San Antonio, Tex., U.S.A., and/or its subsidiary and related companies (collectively,“KCI”).
- Therapy device 110 e.g., a reduced-pressure treatment apparatus
- therapy device 110 may include a reduced-pressure source, such as a vacuum source (e.g., a pump and/or the like), configured to be actuatable (and/or actuated) to apply reduced-pressure (e.g., negative pressure) to dressing 116.
- reduced-pressure applied to a tissue site may typically ranges between -5 millimeters mercury (mm Hg) (-667 pascals (Pa)) and -500 mm Hg (-66.7 kilo (k) Pa).
- Therapy device 110 may also include one or more other components, such as a sensor, a processing unit (e.g., a processor), an alarm indicator, a memory, a database, software, a display device, a user interface, and/or another component that further facilitate reduced-pressure therapy. Additionally, or alternatively, therapy device 110 may be configured to receive fluid, exudate, and or the like via dressing 116 and tube 114. Therapy device 110 may include one or connectors, such as a representative connector 138. Connector 130 is configured to be coupled to tube 114.
- therapy device 110 may include one or more sensors, such a pressure sensor (e.g., a pressure transducer).
- the one or more sensors may be configured to enable therapy device 110 to monitor and/or sense a pressure associated with tube 114 and/or dressing 116.
- An illustrative example of therapy device 110 is described further herein at least with reference to FIG. 7.
- a“tube” broadly refers to a tube, pipe, hose, conduit, or other structure with one or more lumens adapted to convey fluid, exudate, and/or the like, between two ends.
- a tube may be an elongated, cylindrical structure with some flexibility; however, a tube is not limited to such a structure. Accordingly, tube may be understood to include a multiple geometries and rigidity.
- Tube 114 includes one or more lumens (e.g., one or more through conduits), such as a single lumen conduit or multiple single lumen conduits. Tube 114 (e.g., a least one of the one or more lumens) is configured to enable fluid communication between therapy device 110 and dressing 116.
- fluid(s) and/or exudate can be communicated between therapy device 110 and dressing 116 and/or reduced-pressure (e.g., negative pressure) can be applied by therapy device 110 to dressing 116.
- reduced-pressure e.g., negative pressure
- Communication of fluid(s) and application of reduced-pressure can occur separately and/or concurrently.
- tube 114 may include multiple lumens, such as a primary lumen (e.g., a reduce-pres sure/fluid lumen) for application of reduced-pressure and/or communication of fluid, and one or more secondary lumens proximate to or around the primary lumen.
- the one or more secondary lumens e.g., one or more ancillary/peripheral lumens
- the one or more secondary lumens may be coupled to one or more sensors (of therapy device 110), coupled to one or more valves, coupled to an end cap, and/or open to an atmosphere or an ambient environment, as illustrative, non-limiting examples.
- system 100 may include multiple tubes, such as multiple distinct tubes coupled to therapy device 110, dressing 116, or both.
- Tube 114 may include a primary lumen 121 (e.g., a reduce-pressure/fluid lumen) and one or more secondary lumens, such as a first secondary lumen 122 (e.g., an integrity lumen), a second secondary lumen 124 (e.g., a first sense lumen), a third secondary lumen 126 (e.g., a second sense lumen), and a fourth secondary lumen 128 (e.g., a third sense lumen).
- a primary lumen 121 e.g., a reduce-pressure/fluid lumen
- secondary lumens such as a first secondary lumen 122 (e.g., an integrity lumen), a second secondary lumen 124 (e.g., a first sense lumen), a third secondary lumen 126 (e.g., a second sense lumen), and a fourth secondary lumen 128 (e.g., a third sense lumen).
- tube 114 may include fewer than or more than four secondary lumens.
- tube 114 has been described and/or shown as having a circular cross-sectional shape, in other implementations, tube 114 may have a cross-sectional shape other than a circle, such as an oval, triangle, quadrilateral, pentagon, star, or another shape, as illustrative, non-limiting examples.
- dressing 116 includes a connector 130 (also referred to as a dressing connection pad or a pad), a drape 132, and a manifold 134 (also referred to as a distribution manifold or an insert).
- Drape 132 may be coupled to connector 130.
- drape 132 may be coupled to connector 130 via an adhesive, a separate adhesive drape over at least a portion of connector 130 and at least a portion of drape 132, or a combination thereof, as illustrative, non-limiting examples.
- Drape 132 may be configured to couple dressing 116 at tissue site 120 and/or to provide a seal to create an enclosed space (e.g., an interior volume) corresponding to tissue site 120.
- drape 132 may be configured to provide a fluid seal between two components and/or two environments, such as between a sealed therapeutic environment and a local ambient environment.
- drape 132 when coupled to tissue site 120, drape 132 is configured to maintain reduced-pressure (provided by a reduced-pressure source) at tissue site 120.
- Drape 132 may include a drape aperture that extends through drape 132 to enable fluid communication between device and target tissue, as describe further with reference to FIG. 7.
- Drape 132 may be configured to be coupled to tissue site 120 via an adhesive, such as a medically acceptable, pressure-sensitive adhesive that extends about a periphery, a portion, or an entirety of drape 132. Additionally, or alternatively, drape 132 may be coupled to tissue site 120 via a double-sided drape tape, paste, hydrocolloid, hydrogel, and/or other sealing device or element, as illustrative, non-limiting examples.
- an adhesive such as a medically acceptable, pressure-sensitive adhesive that extends about a periphery, a portion, or an entirety of drape 132.
- drape 132 may be coupled to tissue site 120 via a double-sided drape tape, paste, hydrocolloid, hydrogel, and/or other sealing device or element, as illustrative, non-limiting examples.
- Drape 132 may include an impermeable or semi-permeable, elastomeric material, as an illustrative, non-limiting example.
- drape 132 may be liquid/gas (e.g., moisture/vapor) impermeable or semi-permeable.
- “Elastomeric” means having the properties of an elastomer.
- elastomer generally refers to a polymeric material that may have rubber-like properties. More specifically, an elastomer may typically have ultimate elongations greater than or equal to 100% and a significant amount of resilience. The resilience of a material refers to the material’s ability to recover from an elastic deformation.
- Elastomers that are relatively less resilient may also be used as these elastomers.
- elastomers may include, but are not limited to, natural rubbers, polyisoprene, styrene butadiene rubber, chloroprene rubber, polybutadiene, nitrile rubber, butyl rubber, ethylene propylene rubber, ethylene propylene diene monomer, chlorosulfonated polyethylene, polysulfide rubber, polyurethane (PET), EVA film, co-polyester, and silicones.
- drape 132 may include the“V.A.C.® Drape” commercially available from KCI.
- materials of drape 132 may include a silicone drape, 3M Tegaderm® drape, and a polyurethane (PU) drape such as one available from Avery Dennison Corporation of Pasadena, Calif.
- PU polyurethane
- An additional, specific non-limiting example of a material of the drape 132 may include a 30 micrometers (pm) matt polyurethane film such as the Inspire " * ⁇ 2317 manufactured by Exopack " ⁇ Advanced Coatings of Matthews, N.C.
- Manifold 134 is configured to be positioned on and/or near tissue site 120, and may be secured at the tissue site 120, such as secured by drape 132.
- the term“manifold” as used herein generally refers to a substance or structure that may be provided to assist in applying reduced-pressure to, delivering fluids to, or removing fluids and/or exudate from a tissue site and/or target tissue.
- the manifold typically includes a plurality of flow channels or pathways that distribute fluids provided to and removed from the tissue site. In an illustrative implementation, the flow channels or pathways are interconnected to improve distribution of fluids provided to or removed from the tissue site.
- Manifold 134 may be a biocompatible material that may be capable of being placed in contact with the tissue site and distributing reduced-pressure to the tissue site.
- Manifold 134 may include, without limitation, devices that have structural elements arranged to form flow channels, such as foam, cellular foam, open cell foam, porous tissue collections, liquids, gels, and/or a foam that includes, or cures to include, flow channels, as illustrative, non-limiting examples.
- manifold may include polyethylene, a polyolefin, a polyether, polyurethane, a co-polyester, a copolymer thereof, a combination thereof, or a blend thereof.
- manifold 134 may be porous and may be made from foam, gauze, felted mat, or other material suited to a particular biological application.
- manifold 134 may be a porous foam and may include a plurality of interconnected cells or pores that act as flow channels.
- the foam e.g., foam material
- the foam may be either hydrophobic or hydrophilic.
- the porous foam may be a polyurethane, open-cell, reticulated foam such as GranuFoam® material manufactured by Kinetic Concepts, Incorporated of San Antonio, Tex.
- manifold 134 may also be used to distribute fluids such as medications, antibacterials, growth factors, and other solutions to the tissue site.
- Other layers may be included in or on manifold 134, such as absorptive materials, wicking materials, hydrophobic materials, and hydrophilic materials.
- manifold 134 may be configured to wick fluid away from tissue site 120 and to distribute reduced-pressure to tissue site 120. The wicking properties of manifold 134 may draw fluid away from the tissue site 120 by capillary flow or other wicking mechanisms.
- hydrophilic foam is a polyvinyl alcohol, open-cell foam such as V.A.C. WhiteFoam® dressing available from Kinetic Concepts, Inc. of San Antonio, Tex.
- Other hydrophilic foams may include those made from polyether and/or foams that have been treated or coated to provide hydrophilicity .
- manifold 134 may promote granulation at the tissue site 120 if pressure within the sealed therapeutic environment is reduced.
- one or more of the surfaces (e.g., any or all surfaces) of manifold 134 may have an uneven, coarse, or jagged profile that can induce microstrains and stresses at the tissue site 120 if reduced-pressure is applied through the manifold 134 to the tissue site 120.
- manifold 134 may be constructed from bioresorbable materials that do not have to be removed from tissue site 120 following use of the system 100.
- Suitable bioresorbable materials may include, without limitation, a polymeric blend of polylactic acid (PLA) and polyglycolic acid (PGA).
- the polymeric blend may also include without limitation polycarbonates, polyfumarates, and capralactones.
- Manifold 134 may further serve as a scaffold for new cell-growth, or a scaffold material may be used in conjunction with manifold 134 to promote cell-growth.
- a scaffold may be a substance or structure used to enhance or promote the growth of cells or formation of tissue, such as a three- dimensional porous structure that provides a template for cell growth.
- Illustrative examples of scaffold materials include calcium phosphate, collagen, PLA/PGA, coral hydroxy apatites, carbonates, or processed allograft materials.
- Connector 130 includes a body 142 (e.g., housing) and a base 144, and is configured to be coupled to tube 114 via an interface 146 (e.g., a port).
- Base 144 may be coupled, such as via an adhesive, to drape 132 and/or manifold 134.
- base 144 may comprise a flange that is coupled to an end of body 142 and/or is integrally formed with body 142.
- Connector 130, such as body 142, base 144, interface 146, or a combination thereof, may be made of rigid material and/or a semi-rigid material.
- connector 130 may be made from a plasticized polyvinyl chloride (PVC), polyurethane, cyclic olefin copolymer elastomer, thermoplastic elastomer, poly acrylic, silicone polymer, or polyether block amide copolymer.
- PVC plasticized polyvinyl chloride
- connector 130 may be formed of a semi rigid material that is configured to collapse when under a force, such as reduced-pressure less than or equal to a threshold pressure.
- Body 142 includes one or more through channels, such as one or more conduits (e.g., channels) and/or one or more cavities that extend from and/or are coupled to interface 146.
- body 142 may include a primary channel configured to be coupled in fluid communication with a primary lumen (e.g., 121) of tube 114.
- the primary channel may be coupled to a cavity (of body 142) having an aperture open towards manifold 134 (and/or towards tissue site 120).
- the primary channel may include a first opening associated with interface 146 and a second opening (distinct from the aperture of the cavity) associated with the cavity.
- the primary channel and the cavity may define a through channel of body 142 to enable fluid communication between interface 146 and tissue site 120.
- Body 142 also includes a cavity 150 having an opening configured to be coupled to a secondary lumen (e.g., 122) of tube 114.
- a deformable member 152 is positioned within cavity 150 and configured to at least partially deform responsive to reduced-pressure applied to cavity 150. When reduced-pressure stops being applied to cavity 150, deformable member 152 may transition (e.g., expand) to a pre-collapsed state.
- Deformable member 152 may include a collapsible structure, such as a foam (e.g., open cell foam), porous structure (e.g., a sponge or sponge-type material), or an elastomer material.
- Deformable member 152 may be coupled to or encased in a cover layer (not shown), as described further with reference to FIG. 2.
- the cover layer may include a skin or coating configured to be coupled to or encase deformable member 152.
- a skin such as a material used for drape 132, may be formed around at least a portion of deformable member 152.
- cover layer may be formed from a spay/sealer that includes a polymer to form a coating on an outer surface of deformable member 152.
- cavity 150 may be defined by body 142, the cover layer, or both.
- Deformable member 152 and/or the cover layer may be coupled to a body 142.
- deformable member 152 and/or the cover layer may be coupled to body 142 via an adhesive (e.g., glue, epoxy, etc.), RF welding, heat welding, ultrasonic welding, or insert molded, as illustrative, non-limiting examples.
- deformable member 152 When cavity 150 is coupled to a first end of the secondary lumen (e.g., 122), while the second end of the secondary lumen is coupled to an end cap or to an ambient environment, deformable member 152 maintains an undeformed state (e.g., a first state) in which fluid communication via the primary channel and/or the primary lumen (e.g., 121) is unobstructed/unrestricted. However, if connector 130 is coupled in such a manner that reduced -pressure is applied to cavity 150, deformation of deformable member 152 occurs to cause a reduction in a volume of cavity 150.
- a first state e.g., a first state
- deformable member 152 When deformable member 152 is in a deformed state (e.g., a second state), deformable member 152 is configured to cause fluid communication via the primary channel and/or the primary lumen (e.g., 121) to be restricted and/or prohibited, as described further herein with reference to at least FIGS. 2-5.
- Illustrative, non-limiting examples of commercially available connectors into which cavity 150 and deformable member 152 can be incorporated include a“V.A.C. T.R.A.C.® Pad,” or“Sensa T.R.A.C.® Pad” available from Kinetic Concepts, Inc. (KCI) of San Antonio, Tex.
- the one or more through channels may include a secondary channel configured to be coupled in fluid communication with a secondary lumen (e.g., 124, 126, 128).
- the secondary channel may define at least a portion of a through channel of body 142.
- body 142 may include or define channel elements positioned near and in fluid communication with the aperture of the cavity coupled to the primary lumen (e.g., 121) of tube 114.
- the channel elements may be configured to direct fluid(s), exudate, and/or another material toward the cavity and the primary channel of body 142.
- the routing of fluid(s) toward the primary channel maintains one or more secondary channels (e.g., secondary lumens) open/unobstructed for other purposes, such as pressure measurements.
- dressing 116 is coupled to tissue site 120. Additionally, dressing 116 is coupled to device 110 via tube 114. Reduced-pressure can be applied to dressing 116 (e.g., an interior volume of dressing 116) by a reduced-pressure source associated with device 110. If device 110 is coupled to dressing 116 such that reduced-pressure is not provided to cavity 150, deformable member 152 maintains an undeformed state (e.g., the first state) in which fluid communication via the primary channel and/or the primary lumen (e.g., 121) is unobstructed/unrestricted.
- an undeformed state e.g., the first state
- exudate, fluid, and/or another material to be drawn (e.g., removed) from tissue site 120 via the primary lumen 121 of tube 114 e.g., the reduced-pressure/fluid lumen.
- deformation of deformable member 152 occurs to cause a reduction in a volume of cavity 150.
- deformable member 152 is configured to cause fluid communication via the primary channel and/or the primary lumen (e.g., 121) to be restricted and/or prohibited.
- deformable member 152 reducing/limiting the amount of reduced-pressure at the tissue site 120, excess reduced- pressure at tissue site 120 may be avoided.
- dressing 116 includes connector 130 and drape 132 coupled to the connector 130 and is configured to be coupled to tissue site 120.
- Connector 130 may include body 142 (e.g., a connector body) configured to define at least a portion of a first cavity (e.g., 150).
- Connector 130 may also include a conduit coupled to (or defined by) body 142.
- Deformable member 152 may be configured to be transitionable between a first state and a second state, where, when the deformable member is in a first state, deformable member 152 is configured to allow (e.g., enable) flow through the conduit, and when deformable member 152 is in the second state, deformable member 152 is configured to restrict flow through the conduit.
- deformable member 152 may be positioned within the cavity (e.g., 150) and be configured in a first state (when exposed to ambient pressure). When deformable member 152 is in a second state, such as when exposed to reduced-pressure, deformable member 152 is configured to restrict a flow through the conduit. For example, when deformable member 152 in the second state, deformable member 152 may be configured to restrict the flow through the conduit as compared to when deformable member 152 is configured in the first state.
- connector 130 includes connector body 142 configured to define at least a portion of a first cavity (e.g., 150); and deformable member 152 configured to, responsive to reduced-pressure applied to the first cavity, deform to affect flow through the connector body 142.
- the connector includes a conduit coupled to the connector body 142, and deformable member 152 is configure to, responsive to reduced- pressure applied to the first cavity (e.g., 150), deform to affect flow via the conduit.
- connector 130 e.g., cavity 150 and deformable member 152 is configured to restrict and/or prohibit a flow path to reduce or limit an amount of reduced-pressure at the tissue site when reduced-pressure is provided to cavity 150.
- cavity 150 may be coupled to a reduced-pressure source (e.g., a wall-vacuum port) such that reduced-pressure is provided to cavity 150.
- deformable member 152 may deform to cause blockage of one or more conduits/channels of connector 130, thereby avoiding or limiting excess reduced-pressure and/or fluid or exudate removal at tissue site 120. Additionally, blocking one or more conduits/channels of the connector 130 may deter and/or prevent intentionally or accidentally modification and/or bypassing of one or more components/features of system 100 (e.g., the reduced -pressure therapy system). Accordingly, cavity 150 and/or deformable member 152 may enable effective, efficient, and safe reduced-pressure therapy through use of system 100, thereby advancing patient reliability and confidence in the treatment.
- connector 230 may include or correspond to connector 130.
- Connector 230 is configured to be incorporated in or coupled to a dressing, such as a dressing of a reduced-pressure system.
- the dressing may include or correspond to dressing 116 of system 100.
- Connector 230 includes a connector body 242 (e.g., housing), a base 244, an interface 246 (e.g., a port), and a spigot 270.
- Connector body 242 may include or correspond to body 142.
- Base 244 and interface 246 may include or correspond to base 144 and interface 146.
- Connector 230 may include a first end 247 that corresponds to base 244 and a second end 248 that corresponds to interface 246.
- Connector 230 (e.g., connector body 242) may be configured to be coupled to a tissue site (e.g., 120) via first end 247 of body 242 and may be configured to be coupled to a reduced-pressure source via second end 248 of body 242.
- Connector 230 is configured to be coupled to a tube (not shown in FIG. 2) via interface 246.
- interface 246 be sized to be coupled to a tube, as described with reference to FIG. 3.
- interface 246 includes a ridge 249 that may contact an end of the tube.
- connector 230 is described as including ridge 249, in other implementations, connector 130 (e.g., interface 246) may not include ridge 249.
- Body 242 may define at least a portion of one or more cavities, such as a first cavity 250 into which a deformable member 252 is positioned, and a second cavity 254.
- Cavity 250 and deformable member 252 may include or correspond to cavity 150 and deformable member 152, respectively.
- Cavity 250 may have an opening 257 that corresponds to interface 246. The opening 257 may be configured to be coupled to a lumen (e.g., an integrity lumen) of a tube coupled to interface 246.
- a lumen e.g., an integrity lumen
- Deformable member 252 may be coupled to or encased in a cover layer 260, as described with reference to FIG. 1. Accordingly, cavity 250 may be defined by body 242 and the cover layer 260. Cover layer 260 may be coupled to body 242, deformable member 252, or both. In some implementations, deformable member 252 is coupled to body 242 via cover layer 260 and is not directly coupled to body 242 At least a portion 255 of deformable member 252 is not covered or encased by cover layer 260.
- Second cavity 254 includes a cavity aperture 266 at first end 247 of connector body 242.
- Cavity aperture 266 may be defined by base 244, which extends form a peripheral portion of connector body 242, such as a portion of body 242 adjacent to the cavity aperture 266 (of second cavity 254).
- Spigot 270 is coupled to body 242 and may extend at least partially through interface 246.
- Spigot 270 includes a conduit 272 having a first opening 274 and a second opening 276.
- Spigot 270 is configured to be inserted into a primary lumen (e.g., a reduce-pres sure/fluid lumen) of a tube coupled to connector 230 such that conduit 272 is in fluid communication with the primary lumen.
- Conduit 272 may be configured to enable fluid communication between second cavity 254 and the primary lumen (e.g., a reduce-pres sure/fluid lumen) of a tube.
- Deformable member 252 and/or cover layer 260 may include a through hole 262 and may be positioned to enable fluid communication between second cavity 254 and a reduced- pressure source via conduit 272.
- deformable member 252 when deformable member 252 is exposed to ambient pressure, as shown in FIG. 2, deformable member 252 is in a first state (e.g., an undeformed state) and is configured to enable fluid communication between second cavity 254 and a reduced-pressure source via conduit 272. Responsive to reduced -pres sure applied to cavity 250, deformable member 252 is configured to deform to at least partially restrict fluid communication between second cavity 254 and a reduced-pressure source via conduit 272, as described further herein with reference to FIG. 4.
- a first state e.g., an undeformed state
- deformable member 252 Responsive to reduced -pres sure applied to cavity 250, deformable member 252 is configured to deform to at least partially restrict fluid communication between second cavity 254 and a reduced-pressure source via conduit 272, as described
- body 242 may include one or more conduits (e.g., channels) in addition to conduit 272.
- body 242 may include a channel 280 in fluid communication with second cavity 254.
- channel 280 may be in fluid communication with an opening 282 that corresponds to interface 246.
- the opening 282 may be configured to be coupled to a lumen (e.g., a sense lumen) of a tube coupled to interface 246.
- a lumen e.g., a sense lumen
- FIG. 3 another example of a cross-section view of connector 230 is shown. As shown, connector 230 is coupled to a tube 314 (e.g., a multi-lumen tube).
- a first end of tube 314 is coupled to interface 246 (e.g., is in contact with ridge 249) and a second end of tube 314 is configured to be coupled to a reduce pressure source (e.g., device 110).
- interface 246 and tube 314 are coupled together to form a seal.
- interface 246 and tube 314 may be coupled via a binder (e.g., an adhesive and/or a solvent) that forms a bond or weld between interface 246 and tube 314.
- Tube 314 includes a primary lumen 321 (e.g., a reduced-pressure/fluid lumen) and one or more secondary lumens, such as a first secondary lumen 322 (e.g., an integrity lumen) and a second secondary lumen 328 (e.g., a sense lumen).
- a first secondary lumen 322 e.g., an integrity lumen
- a second secondary lumen 328 e.g., a sense lumen
- tube 314 may include a single secondary lumen (e.g., an integrity lumen) or more than two secondary lumens.
- FIG. 6 describes an example of a connector configured to be coupled to a multiple lumen tube including a single primary lumen and a single secondary lumen.
- Primary lumen 321 may be coupled to spigot 270 such that conduit 272 enables fluid communication between second cavity 254 and a reduced-pressure source. Reduced-pressure may be provided to second cavity 254 via primary lumen 321.
- Spigot 270 may be coupled to (attached) and/or integrally formed with a wall of connector 230. Spigot 270 may be inserted into primary lumen 321 and may deform a portion of primary lumen 321 to form a seal with primary lumen 321.
- second opening 276 of conduit 272 may be configured to be positioned within primary lumen 321.
- spigot 270 may be coupled to a surface (e.g., a bore) of primary lumen 321 to form a seal.
- spigot 270 and primary lumen 321 may be coupled via a binder (e.g., an adhesive and/or a solvent) that forms a bond or weld between spigot 270 and primary lumen 321.
- a binder e.g., an adhesive
- First secondary lumen 322 (e.g., integrity lumen) is configured to be coupled to opening 257 such that first secondary lumen 322 (e.g., integrity lumen) is in fluid communication with first cavity 250.
- opening 257 may correspond to a first lumen interface of multiple lumen interfaces of interface 246 (e.g., a port).
- First secondary lumen 322 (e.g., integrity lumen) and first cavity 250 may be configured to be isolated from reduced-pressure provided via primary lumen 321 to second cavity 254.
- first secondary lumen 322 (e.g., integrity lumen) and first cavity 250 may be maintained at an ambient pressure when reduced-pressure is provided via primary lumen 321 to second cavity 254.
- deformable member 252 While at the ambient pressure, deformable member 252 may be in a first state (e.g., an undeformed state) and may not cause blockage of a flow path between second cavity 254 and primary lumen 321 (e.g., a flow path that includes second cavity 254, conduit 272, and primary lumen 321).
- a first state e.g., an undeformed state
- primary lumen 321 e.g., a flow path that includes second cavity 254, conduit 272, and primary lumen 321.
- through hole 262 of deformable member 252 and cover layer 260
- deformable member 252 (and cover layer 260) are described as being positioned at an end of conduit 272, in other implementations, deformable member 252 (and cover layer 260) may be positioned between openings 274, 276, such that deformable member 252 (and cover layer 260) are in-line with respect to conduit 272.
- Second secondary lumen 328 (e.g., sense lumen) is configured to be coupled to opening 282 such that second secondary lumen 328 (e.g., sense lumen) is in fluid communication with second cavity 254.
- opening 282 may correspond to a second lumen interface of multiple lumen interfaces of interface 246 (e.g., a port).
- Second secondary lumen 328 (e.g., sense lumen) may be in fluid communication with second cavity 254 to enable a sensor coupled to second secondary lumen 328 to monitor a pressure associated with second cavity 254.
- channel 280 extends between second cavity 254 and the lumen interface.
- tube 314 has been cut and coupled to a second tube 414 having a single lumen 421.
- Tube 414 may be coupled to a reduced-pressure source, such as wall suction, or a therapy device that is not configured with pressure sensing/monitoring features and/or safety features.
- Reduced-pressure provided via the single lumen 421 may be provided via tube 314, such as via each of primary lumen 321 (e.g., a reduce-pres sure/fluid lumen), first secondary lumen 322 (e.g., an integrity lumen), and second secondary lumen 328 (e.g., a sense lumen).
- deformable member 252 is in the second state (e.g., the deformed state) responsive to reduced-pressure provided to first cavity 250.
- deformable member 252 may be constricted such that through hole 262 is at least partially closed or closed as compared to when the deformable member is in the first state. Accordingly, a flow path from second cavity to primary lumen 321 via conduit 272 is at least partially blocked by deformable member 252 (and/or cover layer 260) as compared to when the deformable member is in the first state.
- reduced-pressure may be provided to second cavity 254 via second secondary lumen 328 (and channel 280).
- a flow path may be present from second cavity to the single lumen 421 via channel 280.
- Diameters of second secondary lumen 328 and channel 280 are smaller than diameters of primary lumen 321 and conduit 272, respectively. Accordingly, reduced-pressure may be provided, and fluid and/or exudate removal, may occur via channel 280; however, such reduced pressure and removal may be at a slow rate as compared to reduced-pressure provided, and fluid and/or exudate removal, via conduit 272 when deformable member 252 is in the first state.
- an effectiveness of connector 230 (e.g., a dressing that includes connector 230) is diminished when the dressing has been modified and/or when one or more features has been bypassed.
- the diminished effectiveness operates as a deterrent to modification of the dressing and/or bypassing one or more features.
- FIG. 5 shows a cross-section of connector 230 that is coupled to a tube 514 having a single lumen 521.
- Tube 514 may be coupled to a reduced-pressure source, such as wall suction, or a therapy device that is not configured with pressure sensing/monitoring features and/or safety features.
- reduced-pressure provided via the single lumen 521 may also be provided to connector 230.
- deformable member 252 responsive to reduced-pressure provided to first cavity 250, deformable member 252 is in the second state (e.g., the deformed state).
- connector 230 when connector 230 is directly connected to the tube 514, connector 230 including deformable member 252 provides the same functionality to restrict or prohibit a flow path via conduit 272 as when a multi-lumen tube (e.g., 314) is cut and when a single lumen tube 514 is connected to interface 246.
- a multi-lumen tube e.g., 314
- Connector 630 includes a connector body 642 (e.g., housing), a base 644, an interface 646 (e.g., a port), and a spigot 670.
- Connector body 642 e.g., a housing
- Base 644 may include or correspond to base 144 or base 244.
- Interface 646 may include or correspond to interface 146 or interface 246.
- Connector 630 may include a first end 647 that corresponds to base 644 and a second end 648 that corresponds to interface 646.
- Connector 630 may be configured to be coupled to a tissue site (e.g., 120) via first end 647 of body 642 and may be configured to be coupled to a reduced- pressure source via second end 648 of body 642.
- connector 630 is configured to be coupled to a tube 614 via interface 646.
- interface 646 be sized to be coupled to tube 614.
- Tube 614 includes a primary lumen 621 (e.g., a reduce-pres sure/fluid lumen) and a secondary lumen 622 (e.g., an integrity lumen).
- Body 642 may define at least a portion of one or more cavities, such as a first cavity 650 into which a deformable member 652 is positioned, and a second cavity 654.
- Cavity 650 may include or correspond to cavity 150 or cavity 250.
- Deformable member 652 may include or correspond to deformable member 152 or deformable member 252.
- Deformable member 652 may be coupled to or encased in a cover layer 660, such as cover layer 260. Accordingly, cavity 650 may be defined by body 642 and cover layer 660.
- Cavity 650 may have an opening 657 that corresponds to interface 646. The opening 657 may be configured to be coupled to a lumen (e.g., an integrity lumen) of tube 614.
- a lumen e.g., an integrity lumen
- Second cavity 654 includes a cavity aperture 665 at first end 647 of connector body 642.
- Cavity aperture 665 may be defined by base 644, which extends form a peripheral portion of connector body 642 adjacent to the cavity aperture 665 (of second cavity 654).
- Spigot 670 is coupled to body 642 and may extend at least partially through interface 646.
- Spigot 670 includes a conduit 672.
- Conduit 672 may include or correspond to conduit 272.
- Primary lumen 621 may be coupled to spigot 670 such that conduit 672 enables fluid communication between second cavity 654 and a reduced-pressure source. Reduced-pressure may be provided to second cavity 654 via primary lumen 621.
- Spigot 670 may be coupled to (attached) and/or integrally formed with a wall of connector 630 (e.g., body 642). Spigot 670 may be inserted into primary lumen and to form a seal.
- Deformable member 652 and/or cover layer 660 may include a through hole 662 and may be positioned to enable fluid communication between second cavity 654 and a reduced- pressure source via conduit 672.
- through hole 662 of deformable member 652 (and cover layer 660) may be configured to align with an opening of conduit 672 when deformable member 652 is in the first state.
- Secondary lumen 622 e.g., integrity lumen
- opening 657 may correspond to a first lumen interface of multiple lumen interfaces of interface 646 (e.g., a port).
- Secondary lumen 622 and first cavity 650 may be configured to be isolated from reduced-pressure provided via primary lumen 621 to second cavity 654.
- secondary lumen 622 (e.g., integrity lumen) and first cavity 650 may be maintained at an ambient pressure when reduced-pressure is provided via primary lumen 621 to second cavity 654.
- deformable member 652 While at the ambient pressure, deformable member 652 may be in a first state (e.g., an undeformed state) and may not cause blockage of a flow path between second cavity 654 and primary lumen 621.
- deformable member 652 When deformable member 652 is exposed to ambient pressure, deformable member 652 is in a first state (e.g., an undeformed state) and is configured to enable fluid communication between second cavity 654 and a reduced-pressure source via conduit 672. Responsive to reduced-pressure applied to cavity 650, deformable member 652 is configured to deform to at least partially fluid communication between second cavity 654 and a reduced-pressure source via conduit 672. Additionally, blocking one or more conduits/channels of the connector 630 may deter and/or prevent intentionally or accidentally modification and/or bypassing of one or more components/features of a reduced therapy system. Accordingly, cavity 650 and/or deformable member 652 may enable effective, efficient, and safe reduced-pressure therapy through use of the reduced-therapy system, thereby advancing patient reliability and confidence in the treatment.
- a first state e.g., an undeformed state
- deformable member 652 Responsive to reduced-pressure applied to cavity 650, deformable member 652 is
- System 700 includes a reduced-pressure therapy device 710 (e.g., a reduced-pressure therapy apparatus), a tube 714, and a dressing 716.
- Dressing 716 is coupled to device 710 via tube 714.
- Device 710 and dressing 716 may include or correspond to device 110 and dressing 116, respectively.
- Tube 714 may include or correspond to tube 114, tube 314, tube 414, tube 514, or tube 614.
- Dressing 716 is configured to be coupled to (e.g., adhered to) a tissue site 720 of a patient.
- Tissue site 720 may include or correspond to tissue site 120.
- Dressing 716 may include one or more components, such as a connector 730, a drape 732, a manifold 734, or a combination thereof, as illustrative, non-limiting examples.
- Connector 730 may include or corresponds to connector 130, connector 230, or connector 630.
- Drape 732 and manifold 734 may include or correspond to drape 132 and manifold 134, respectively.
- Drape 732 may be coupled to connector 730 and/or manifold 734, and may include an opening 735 (e.g., a drape aperture) to enable communication (e.g., fluid communication) between connector 730 and manifold 734.
- an opening 735 e.g., a drape aperture
- drape 732 is coupled to tissue site 720 via a representative adhesive 737, such as a medically acceptable, pres sure- sensitive adhesive that extends about a periphery, a portion, or an entirety of drape 132. Additionally, or alternatively, drape 732 may be coupled to tissue site 720 via a double-sided drape tape, paste, hydrocolloid, hydrogel, and/or other sealing device or element, as illustrative, non-limiting examples. Drape 732 is configured to be coupled to tissue site 720 such that drape 732 covers manifold 734 (and target tissue 736) to form and/or define an interior volume 738 between drape 732 and tissue site 720 (e.g., target tissue 736).
- a representative adhesive 737 such as a medically acceptable, pres sure- sensitive adhesive that extends about a periphery, a portion, or an entirety of drape 132.
- drape 732 may be coupled to tissue site 720 via a double-sided drape tape, paste, hydrocolloid, hydrogel, and/or
- interior volume 738 may correspond to a sealed therapeutic environment.
- the tissue proximate the target tissue 736 may be undamaged epidermis peripheral to target tissue 736.
- the sealed therapeutic environment may be isolated from an external environment, such as an external environment at ambient pressure.
- manifold 734 is positioned within interior volume 738 at (e.g., on or above) target tissue 736 of tissue site 720.
- manifold 734 may contact tissue site 720, target tissue 736, or both.
- manifold 734 may partially or completely fill the cavity.
- manifold 734 may be placed over target tissue 736.
- Manifold 734 may take one or more forms, and/or may have one or more configurations (e.g., sizes, shapes, and/or thicknesses), depending on one or more factors, such as the type of treatment being implemented, the nature and size of target tissue 736, a stage of treatment, or a combination thereof.
- the size and shape of the manifold 734 may be adapted to target tissue 736 and/or tissue site 720.
- manifold 734 may be adapted to a contours of target tissue 736 and/or tissue site 720.
- manifold 734 includes a foam, such as GranuFoam® material manufactured by Kinetic Concepts, Incorporated of San Antonio, TX, as an illustrative, non-limiting example.
- Connector 730 may include a connector body 742, a base 744, and an interface 746 (e.g., a port).
- Connector body 742 e.g., a housing
- Base 744 may include or correspond to base 144, base 244, or base 644.
- Interface 746 may include or correspond to interface 146, interface 246, or interface 646.
- Interface 746 is configured to be coupled to tube 714.
- Body 742 may define one or more cavities, such as a cavity 750 (e.g., a first cavity) into which a deformable member 752 is positioned.
- Cavity 750 may include or correspond to cavity 150, cavity 250, or cavity 650.
- the deformable member 752 may include or correspond to deformable member 152, deformable member 252, or deformable member 652.
- deformable member 752 is configured to at least partially deform responsive to reduced-pressure applied to cavity 750.
- deformable member 752 may include or be coupled to a cover layer, such as cover layer 260, 660.
- body 742 may include one or more through channels, such as one or more conduits (e.g., channels) and/or one or more additional cavities (e.g., a second cavity), that extend from and/or are coupled to interface 146.
- body 742 may include a conduit and a second cavity that are in fluid communication with interior volume 738.
- the second cavity may have an aperture defined by base 744, and which is positioned over manifold 734, to enable fluids and/or exudate to be are drawn from target tissue 736.
- connector 730 may be positioned on manifold 734 such that a perimeter of the aperture (defined by base 744) is in direct contact with manifold 734.
- connector 730 may operate to maintain fluid communication between interior volume 738 and device 710 via tube 714, and to prevent fluid communication between interior volume (e.g., a sealed therapeutic environment formed by dressing 716) and the ambient environment.
- deformable member 752 is configurable in a first state (e.g., an undeformed state) and in a second state (e.g., a deformed state).
- first state e.g., the undeformed state
- second state e.g., a deformed state
- deformable member 752 is configured and/or positioned to enable reduced-pressure to be communicated via the conduit and/or the second cavity.
- deformable member 752 is in the second state
- deformable member 752 (and/or the cover layer) is configured to at least partially restrict and/or block a flow path through the conduit and/or the second cavity.
- deformable member 752 may transition (e.g., constrict) from the first state to the second state responsive to reduced-pressure applied to cavity 750, thereby causing a portion of the cover layer (e.g., 260, 660) to at least partially block an opening of the conduit and/or the second cavity.
- a portion of the cover layer e.g., 260, 660
- Tube 714 includes one or more lumens.
- tube 714 may include a reduce-pressure/fluid lumen (e.g., 120), an integrity lumen (e.g., 122), a first sense lumen (e.g., 124), and a second sense lumen (e.g., 126).
- a first end of tube 714 is coupled to dressing 716 and a second end of tube 714 is coupled to device 710.
- the second end of tube 714 may include a therapy device connector configured to couple (e.g., mate) with device 710.
- Device 710 includes a controller 760, one or more interfaces 762, one or more I/O devices 764, and one or more connectors, such as a representative connector 766.
- Device 710 further includes one or more conduits 768, a fluid chamber 770, pressure sensors 772, 774, one or more valves 776 (e.g., solenoid valves), and a reduced-pressure source 778.
- Connector 766 such as connector 138, is configured to be coupled to tube 714, such as the second end of tube 714.
- Connector 766 includes one or more port/interfaces, such as a first port/interface 780, a second port/interface 782, a third port/interface 784, a fourth port/interface 786.
- first port/interface 780 may include or be coupled to an endcap or wall, or may be open to an ambient environment (e.g., ambient pressure).
- second port/interface 782, third port/interface 784, and fourth port/interface 786 is coupled to one or more components of device 710 via one or more conduits (e.g., 768).
- second port/interface 782 is coupled through fluid chamber 770 (e.g., a canister) to reduced-pressure source 778
- third port/interface 784 is coupled to a first pressure sensor 772
- fourth port/interface 786 is coupled to a second pressure sensor 774.
- the sensors 772, 774 may be configured to generate data indicative of pressure within dressing 716.
- device 710 may include fewer than two pressure sensors, such as no pressure sensors or a single pressure sensor, or more than two pressure sensors.
- each of second port/interface 782, third port/interface 784, and fourth port/interface 786 is coupled to a corresponding valve (e.g., 776), such as a solenoid valve, which is configured to change pressure from dressing 716.
- Second port/interface 782 is coupled to reduced-pressure source 778 and a corresponding valve 776 via fluid chamber 770 (e.g., a liquid-collection chamber).
- Reduced-pressure source 778 is configured to provide reduced-pressure to interior volume 738 of dressing 716 such that interior volume 738 is reduced, and/or reduced-pressure is applied to at least target tissue 736.
- Reduced-pressure source 778 may include a mechanically and/or electrically-powered device, such as a manually-actuated or manually- charged pump, a vacuum pump, an electrically-driven vacuum pump, a suction pump, a wall suction port, a micro-pump, a disc-pump, and/or the like, as illustrative, non-limiting examples.
- Controller 760 includes a processor 790 coupled to a memory 792 (e.g., a computer- readable storage device).
- Memory 792 such as a non-transitory computer-readable storage medium, may include volatile memory devices (e.g., random access memory (RAM) devices), nonvolatile memory devices (e.g., read-only memory (ROM) devices, programmable read-only memory, and flash memory), or both.
- RAM random access memory
- ROM read-only memory
- flash memory flash memory
- Memory 792 may be configured to store instructions 794, a pressure profile 796, and one or more thresholds 798. Instructions 794 may be configured to, when executed by the one or more processors 790, cause the processor(s) 790 to perform one or more operations.
- Pressure profile 796 may include desired target pressures to be provided to a patient over a time period.
- the pressure profile 796 may include a set-up profile applying target pressures at the commencement of therapy treatments and a maintenance profile for applying target pressure during therapy.
- One or more thresholds 798 may include one or more one or more pressure thresholds, one or more time thresholds, one or more other thresholds, or a combination thereof.
- Processor 790 may include a microcontroller/microprocessor, a central processing unit (CPU), a field-programmable gate array (FPGA) device, an application-specific integrated circuits (ASIC), another hardware device, a firmware device, or any combination thereof.
- Processor 790 may be configured to execute instructions 794, execute and/or operate according to pressure profile 796, and / process sensor data generate by sensors 772, 774.
- processor 790 may be configured to process sensor data (e.g., pressure signals) received by one or more sensors (e.g., 772, 774) and/or monitor the sensor data.
- sensor data e.g., pressure signals
- processor 790 may be configured to issue one or more alerts according to a pre-determined pressure therapy (e.g., pressure profile 796) for a patient and/or based on one or more thresholds 798.
- the one or more alerts may be in the form of a visual alert (e.g., a light indicator), a tactile alert, an audible alert, a message presented via a display, or a message transmitted to another device.
- processor 790 may provide an indication that the sensor data (e.g., the monitored pressure at dressing 716) is following pressure profile 796.
- processor 790 may initiate a visual indication (e.g., a light indicator), a tactile indication, an audible indication, a message presented via a display, or a message transmitted to another device.
- the one or more interfaces 762 may include a wired interface, a wireless interface, or both.
- the one or more interfaces 762 may include a network interface and/or a device interface configured to be communicatively coupled to one or more other devices.
- interfaces 762 may include a transmitter, a receiver, or a combination thereof (e.g., a transceiver), and may enable wired communication, wireless communication, or a combination thereof.
- the one or more interfaces 762 may include serial interfaces (e.g., universal serial bus (USB) interfaces or Institute of Electrical and Electronics Engineers (IEEE) 1394 interfaces), parallel interfaces, display adapters, audio adapters, and other interfaces
- the one or more I/O devices 764 may include a mouse, a keyboard, pointing devices, a display device, the camera, speakers, microphones, touch screens, other I/O devices, or a combination thereof.
- Processor 790 may be configured to send and/or receive data via the interface(s) 762 and/or the I/O device(s) 764.
- dressing 716 is coupled to tissue site 720 so as to cover target tissue 736. Additionally, dressing 716 is coupled to device 710 via tube 714.
- processor 790 receives an input via I/O device 764, such as a touchscreen, to select a pressure profile (e.g., 796) of multiple pressure profiles stored at memory 792, to initiate reduced-pressure therapy, or both. Alternatively, the input may indicate a value of a reduce-pressure to be provided and/or maintained. Responsive to the input, controller 760 (e.g., processor 790) generates one or more commands to initiate operations of one or more components of device 710.
- processor 790 may access pressure profile 796 (e.g., a set-up profile or a maintenance profile). Additionally, or alternatively, processor 790 may activate and/or regulate reduced-pressure source 778, one or more valves 776, or both. In some implementations, processor 790 may control operation of reduced-pressure source 778, one or more valves 776 based on at least in part on the input (e.g., the pressure profile 796 selection or the value of the reduced-pressure).
- pressure profile 796 e.g., a set-up profile or a maintenance profile.
- processor 790 may activate and/or regulate reduced-pressure source 778, one or more valves 776, or both.
- processor 790 may control operation of reduced-pressure source 778, one or more valves 776 based on at least in part on the input (e.g., the pressure profile 796 selection or the value of the reduced-pressure).
- reduced- pressure source 778 may apply reduced-pressure to dressing 716.
- reduced-pressure developed by reduced-pressure source 778 may be delivered through tube 714 to connector 730 of dressing 716.
- the reduced-pressure source 778 can reduce a pressure in interior volume 738.
- Internal volume (e.g., a sealed therapeutic environment) and/or target tissue 736 may be isolated from an external environment (associated with an ambient pressure).
- Reduced-pressure applied to interior volume 738 can induce macrostrain and microstrain in tissue site 720.
- reduced-pressure applied uniformly through the manifold 734 in interior volume 738 induces macrostrain and microstrain in target tissue 736.
- pressure at dressing 716 may be communicated to first pressure sensor 772 and second pressure sensor 774 via first sense lumen (e.g., 124) and second sense lumen (e.g., 126), respectively.
- the pressure communicated by via first sense lumen (e.g., 124) and second sense lumen (e.g., 126) may be representative of the pressure at the target tissue 736.
- Each of first pressure sensor 772 and second pressure sensor 774 are configured to generate sensor data that is communicated to controller 760 (e.g., processor 790).
- controller 760 e.g., processor 790
- controller 760 may initiate operation of one or more valves (e.g., 776) between an open position and a closed position.
- processor 790 may be configured to adjust a particular valve in response to a comparison of the sensor data (indicating that a pressure within the interior volume (e.g., 738)) to a threshold (e.g., 798).
- processor 790 is configured to control reduced-pressure source 778 (e.g., a reduced-pressure source device) and/or one or more valves 776 based at least in part on the sensor data.
- processor 790 may be configured to deactivate reduced-pressure source 778 in response to a determination that the sensor data indicates that a pressure within the interior volume (e.g., 738) is less than a first threshold (e.g., a first threshold pressure value).
- processor 790 is configured to operate at least one valve (e.g., 776) towards the open position upon or after deactivation of reduced- pressure source 778.
- the at least one valve may include the valve coupled to reduced-pressure source 778, the valve coupled to first pressure sensor 772, and/or the valve coupled to second pressure sensor 774.
- processor 790 may be configured to activate reduced-pressure source 778 in response to a determination that the sensor data indicate that a pressure within the interior volume (e.g., 738) is greater than or equal to a second threshold (e.g., a second threshold pressure value). Activation of reduced-pressure source 778 may reduce pressure within the interior volume (e.g., 738).
- processor 790 is configured to operate at least one valve (e.g., 776) towards the closed position upon or after activation of reduced-pressure source 778.
- the first threshold and the second threshold may have the same value. Alternatively, the first threshold and the second threshold may have different values (e.g., the second threshold may be greater than the first threshold).
- valve 776 coupled to first pressure sensor 772 may be operated independent of valve 776 coupled to second pressure sensor 774.
- controller 760 may operate valve 776 coupled to first pressure sensor 772 based on sensor data received from first pressure sensor 772 and/or based on a first set of one or more thresholds (e.g., 798).
- Controller 760 may operate valve 776 coupled to second pressure sensor 774 based on sensor data received from second pressure sensor 774 and/or based on a second set of one or more thresholds (e.g., 798).
- the first set of one or more thresholds and the second set of one or more thresholds may include one or more of the same threshold value(s) and/or one or more different threshold value(s).
- controller 760 may operate one or more of the valves based on an average of sensor data of two or more sensors.
- controller 760 may control one or more valves, such as the valve coupled to reduced-pressure source 778 based on an average of the sensor data (received from sensors 772, 774) and a third set of one or more thresholds.
- the third set of one or more thresholds may include one or more of the same threshold value(s) and/or one or more different threshold value(s) as the first set of one or more thresholds and/or the second set of one or more thresholds.
- Reduced-pressure provided by reduced-pressure source 778 via reduced- pressure/fluid lumen can cause exudate, fluid, and/or another material to be drawn (e.g., removed) from target tissue 736 (e.g., tissue site 720) via tube 714 (e.g., reduced- pressure/fluid lumen) and second port/interface 782. Exudate, fluid, and/or another material removed via second port/interface 782 may be collected in fluid chamber 770 (e.g., a canister) for disposal.
- device 710 may include a sensor (not show) coupled to controller 760 (e.g. processor 790) and configured to monitor a volume of fluid chamber 770.
- processor 790 may receive sensor data from the sensor that indicates a fill level of fluid chamber 770.
- processor 790 is configured to deactivation of reduced-pressure source 778, operate at least one valve (e.g., 776) towards the open position, or both.
- processor 790 may initiate a notification (e.g., an alarm), such as a message via a display, an audio and/or visual notification, transmit a data message to another device, or a combination thereof.
- a notification e.g., an alarm
- deformation of deformable member 752 occurs to cause a reduction in a volume of cavity 750.
- deformable member 752 is configured to cause fluid communication via the primary channel and/or the primary lumen (e.g., 121) to be restricted and/or prohibited. Additionally, by deformable member 752 reducing/limiting the amount of reduced-pressure at the tissue site 720, excess reduced-pressure at tissue site 720 may be avoided.
- FIG. 7 describes system 700 for providing reduced-pressure therapy.
- System 700 may advantageously include connector 730 (e.g., cavity 750 and deformable member 752) configured to restrict and/or prohibit a flow path to reduce or limit an amount of reduced- pressure at the tissue site if reduced-pressure is provided to cavity 750.
- connector 730 e.g., cavity 750 and deformable member 752
- deformable member 752 may constricts (e.g., forms) to cause blockage of one or more conduits/channels of connector 730, thereby avoiding or limiting excess reduced-pressure and/or fluid or exudate removal at tissue site 720.
- Blocking one or more conduits/channels of the connector 730 may deter and/or prevent intentionally or accidentally modification and/or bypassing of one or more components/features of system 700. Accordingly, cavity 750 and/or deformable member 752 may enable effective, efficient, and safe reduced-pressure therapy through use of system 700, thereby advancing patient reliability and confidence in the treatment.
- FIG. 8 illustrates a method 800 of operating a connector (of a dressing).
- the method 800 may be performed at or by a connector, such as connector 130, connector 230, connector 630, or connector 730.
- the connector may be included in a reduced- pressure system (e.g., a reduced-pressure therapy system), such as system 100 (e.g., connector 130), a system that includes connector 230, a system that includes connector 630, or the system 700 (e.g., connector 730).
- a reduced- pressure system e.g., a reduced-pressure therapy system
- Method 800 includes receiving reduced-pressure at a cavity of a connector, at 810.
- the cavity may include or correspond to cavity 150, cavity 250, cavity 650, or cavity 750.
- the reduced-pressure may be received at the connector from a reduced power source via a tube.
- Method 800 further includes, responsive to the reduced-pressure, deforming a deformable member positioned within the cavity, at 812.
- the deformable member may include or correspond to deformable member 152, deformable member 252, deformable member 652, or deformable member 752.
- Method 800 also includes blocking, based on the deformable member, at least a portion of an opening of a conduit of the connector, 814.
- the conduit may include conduit 272 or conduit 672. Additionally, or alternatively, the conduit may be at least partially blocked by a cover layer (e.g., 260, 660).
- method 800 describes operation of a connector to restrict and/or prohibit a flow path to reduce or limit an amount of reduced-pressure at the tissue site if reduced-pressure is provided to the cavity.
- a connector By causing a blockage of one or more conduits/channels of the connector, excess reduced-pressure and/or fluid or exudate removal at the tissue site may be limited and/or avoided.
- blocking one or more conduits/channels of the connector may deter and/or prevent intentionally or accidentally modification and/or bypassing of one or more components/features of the reduced therapy system. Accordingly, the connector may enable effective, efficient, and safe reduced-pressure therapy through use of the reduced- therapy system.
- FIG. 9 illustrates a method 900 of operating a reduced-pressure system.
- the method 900 may be performed at or by system 100 (e.g., connector 130), a system that includes connector 230, a system that includes connector 630, or the system 700 (e.g., connector 730).
- Method 900 includes coupling a dressing including a connector to a tissue site of a patient, at 910.
- the dressing may include or correspond to dressing 116, a dressing that includes connector 230, a dressing that includes connector 630, or dressing 716.
- the tissue site may include or correspond to tissue site 120, tissue site 720, and/or target tissue 736.
- the connector may include or correspond to connector 130, connector 230, connector 630, or connector 730.
- the connector includes a connector body configured to define at least a portion of a cavity in which a deformable member is positioned.
- the connector body may include or correspond to body 142, body 242, body 642, or body 742.
- the cavity may include or correspond to cavity 150, cavity 250, cavity 650, or cavity 750.
- the cavity may be defined by the body, a cover layer (e.g., 260, 660), a spigot (e.g., 270, 670), an interface (e.g., 146, 246, 646, 746), or a combination thereof.
- the deformable member may include or correspond to deformable member 152, deformable member 252, deformable member 652, or deformable member 752.
- Method 900 further includes coupling the dressing to a reduced-pressure source via one or more tubes, at 912.
- the reduced-pressure source may include or correspond to reduced-pressure source 778.
- the one or more tubes may include or correspond to tube 114, tube 314, tube 414, tube 514, tube 614, and/or tube 714.
- Method 900 also includes providing, by the reduced-pressure source, reduced- pressure to the dressing, at 914. If the dressing is coupled to the reduced-pressure source such that reduced-pressure is not provided to the cavity, deformable member maintains an undeformed state (e.g., the a state) in which fluid communication via a primary channel (of the connector) and/or a primary lumen (e.g., 121) of a tube is unobstructed/unrestricted. In such situations, exudate, fluid, and/or another material may be drawn (e.g., removed) from the tissue site via the primary lumen (e.g., the reduced-pressure/fluid lumen).
- the primary lumen e.g., the reduced-pressure/fluid lumen
- deformation of deformable member occurs to cause a reduction in a volume of cavity.
- deformable member is configured to cause fluid communication via the primary channel and/or the primary lumen to be restricted and/or prohibited.
- method 900 describes operation of a reduced-pressure system (e.g., a reduced- pressure therapy system) to a tissue site.
- the system may advantageously be configured to restrict and/or prohibit a flow path to reduce or limit an amount of reduced-pressure at the tissue site if reduced-pressure is provided to the cavity of connector.
- By restricting and/or prohibiting the flow path excess reduced-pressure and/or fluid or exudate removal at the tissue site may be limited and/or avoided in situations where one or more components/features of the reduced therapy system were intentionally or accidentally modified and/or bypassed.
- the system may be configured to ensure effective, efficient, and safe reduced-pressure therapy.
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Abstract
This disclosure describes devices, systems, and methods related to a connector for a dressing, such as a dressing of a reduced-pressure therapy system. An example of a connector includes a connector body configured to define at least a portion of a first cavity. The connector further includes a conduit coupled to the connector body and a deformable member positioned within the first cavity. The deformable member positioned in the first cavity is configured to, responsive to reduced-pressure applied to the first cavity, deform to affect flow through the conduit.
Description
DESCRIPTION
APPARATUS, SYSTEM, AND METHOD FOR A CONNECTOR OF A DRESSING
OF A REDUCED-PRESSURE SYSTEM
CROSS-REFERENCED WITH REUATED APPUICATIONS
[0001] This application claims priority to and the benefit of U.S. Provisional Application No. 62/739,696, filed October 1, 2018, which is incorporated into the present application by reference.
TECHNICAU FIEUD
[0002] Aspects of the present disclosure relate generally to a connector, and more specifically, but not by way of limitation, to a connector for a dressing and/or a system for reduced -pressure therapy and related methods.
BACKGROUND
[0003] Clinical studies and practice have shown that reducing pressure in proximity to a tissue site can augment and accelerate growth of new tissue at the tissue site. Applications of this phenomenon are numerous, but have proven particularly advantageous for treating wounds. Regardless of the etiology of a wound, whether trauma, surgery, or another cause, care of the wound can impact the outcome. Treatment of wounds with reduced-pressure may be commonly referred to as“reduced-pressure wound therapy,” but is also known by other names, including“reduced-pressure therapy”,“negative-pressure therapy,”“negative pressure wound therapy,” and“vacuum therapy,” as illustrative, non-limiting examples. Reduced- pressure therapy may provide one or more benefits, including migration of epithelial and subcutaneous tissues, improved blood flow, and/or micro-deformation of tissue at a wound site. These benefits can increase development of granulation tissue and reduce healing times.
[0004] Reduced-pressure therapy is typically provided by a reduced-pressure system including one or more components and/or one or more devices. To illustrate, a conventional reduced -pressure system may include a dressing, one or more tubes, a therapy device (e.g., a reduced-pressure source), or a combination thereof, as illustrative, non-limiting examples. The dressing may be placed at a tissue site and coupled to the reduced-pressure source via the tube. The reduced-pressure source is configured to establish reduced-pressure (e.g., a reduced- pressure environment) at the dressing and the dressing is configured to maintain the reduced- pressure at the tissue site. The reduced-pressure system may be configured with one or more
features, such as pressure monitoring and/or regulation, one or more safety warnings, etc. To illustrate, the dressing and the therapy device may be configured to be coupled via a multi lumen tube in which a primary lumen is configured to provide reduced-pressure and one or more secondary lumens are configured to be used for pressure monitoring. Additionally, or alternatively, the reduced-pressure system may be configured to provide one or more notifications of activation of reduced-pressure, low pressure, monitored pressure, over pressure, etc.
[0005] During some reduced-pressure treatments, one or more features (e.g., pressure monitoring, pressure regulation, and/or safety) may be inadvertently or purposefully bypassed. Additionally, or alternatively, during a reduced-pressure treatment, one or more components may be improperly installed or applied, one or more components may be modified, and/or a component may be coupled to a device not designed or approved for use with the component. For example, a dressing may be provided with or include a multi-lumen tube affixed to the dressing. The multi-lumen tube may have a device connector at an end of the multi-lumen tube that is configured to be coupled to a particular reduced-pressure therapy device that includes pressure monitoring and/or regulation. In situations where the particular reduced-pressure therapy device is not readily available, an individual may cut the tube to remove the device connector, slide a piece of tube (e.g., a single lumen tube) over the multi-lumen tube, and connect the single lumen tube to an available reduced-pressure therapy device or to a wall suction port. Modifying one or more components and/or bypassing (e.g., circumventing) features of the reduced-pressure system can reduce effectiveness of the treatment, prolong a treatment period, create an excess reduced-pressure condition that may damage healthy tissue, and/or diminish patient reliability and confidence in the treatment, as illustrative, non-limiting examples. Additionally, or alternatively, modifying one or more components (of the reduced- pressure system) and/or bypassing features can create legal liability for a device manufacture, device operator, healthcare providers, and/or a facility or organization responsible for providing the reduced-pressure therapy.
SUMMARY
[0006] This disclosure describes devices, systems, and methods related to a connector for a dressing, such as a dressing of a reduced-pressure therapy system. For example, the connector (e.g., a pad) is configured to be coupled to a reduced-pressure source via a tube, such as a multi lumen tube. The connector includes a connector body (e.g., a housing) configured to define at
least a portion of a first cavity. The connector further includes a conduit coupled to the connector body and a deformable member positioned within the first cavity. In some implementations, the connector further includes a cover layer coupled to the connector body, the deformable member, or both. The deformable member may be configurable between a first state (e.g., an undeformed state) and a second state (e.g., a deformed state). In the first state (e.g., the undeformed state), the deformable member is configured and/or positioned to enable reduced-pressure to be communicated via the conduit. When the deformable member is in the second state, the deformable member is configured to cause a flow path through the conduit to be at least partially restricted and/or blocked. For example, the deformable member may transition (e.g., constrict) from the first state to the second state, thereby causing a portion of the cover layer to at least partially block an opening of the conduit.
[0007] To illustrate, during operation, the connector is configured to be coupled to a multi lumen tube such that the conduit is in fluid communication with a first lumen of the multi lumen tube and the cavity is in fluid communication with a second lumen of the multi-lumen tube. The conduit is configured to be fluidly coupled to the reduced-pressure source via the first lumen and the cavity is configured to be isolated from the reduced-pressure source. For example, the second lumen includes a first end having an opening that is fluidly coupled to the cavity and a second end having an opening that is open to an ambient pressure or is blanked off (e.g., coupled to an endcap). When the reduced-pressure system is connected and operated such that reduced-pressure is communicated via the conduit (and the first lumen), reduced- pressure is not provided to the cavity (including the deformable member) and the deformable member is maintained in the first state (e.g., the undeformed state) because it is not at a reduced- pressure pressure. In some implementations, the multi-lumen tube may include a third lumen that is configured to enable the reduced-pressure system to monitor reduced-pressure at the dressing.
[0008] However, in situations where one or more components (or features) of the reduced- pressure system have been modified or bypassed, the cavity and/or the second lumen may be coupled to receive reduced-pressure (e.g., sub-atmospheric pressure). For example, an individual may cut the multi-lumen tube and may couple the cut end of the multi-lumen to a reduced-pressure source such that each lumen of the remaining portion of the multi-lumen tube (coupled to the dressing) receives reduced-pressure. In such situations, reduced-pressure is provided to the cavity via the second lumen and, responsive to the reduced-pressure, the deformable member may deform (e.g., constrict) and restrict or block at least a portion of the
opening of the conduit. In implementations where the multi-lumen tube includes the third lumen and the multi-lumen tube is also coupled to the reduce-pressure source, reduced-pressure may be provided to the dressing via the third lumen. In some implementations, deformation of the deformable member may also restrict or block the flow path of the third lumen.
[0009] Thus, the connector (e.g., the cavity and the deformable member) of the present disclosure is configured to deter modifications and/or alterations to a reduced-pressure system. For example, when the connector is coupled to a reduced-pressure source (e.g., a wall-vacuum port) such that reduced-pressure is provided to the cavity, the deformable member may constrict (e.g., forms) to block one or more conduits/channels of the connector. Blocking one or more conduits/channels of the connector may restrict and/or prohibit a flow path that reduces or limits an amount of reduced-pressure at the tissue site. Reducing/limiting the amount of reduced-pressure at the tissue site, the connector advantageously avoids excess reduced- pressure at the tissue site when the connector is coupled to a reduced power source, such as an unregulated reduced power source. Additionally, the connector beneficially provides an ability to disconnect, reduce, and/or limit the delivery of reduced-pressure to the tissue site when one or more components/features of the reduced therapy system are intentionally or accidentally modified and/or bypassed. Accordingly, effective, efficient, and safe reduced-pressure therapy may be achieved through use of the reduced-therapy system, thereby advancing patient reliability and confidence in the treatment.
[0010] Some embodiments of the present apparatuses (e.g., of a connector) comprise: a connector body configured to define at least a portion of a first cavity; a conduit coupled to the connector body; and a deformable member positioned within the first cavity and configured to be transitionable between a first state and a second state, wherein, when the deformable member is in a first state, the deformable member is configured to allow flow through the conduit, and when the deformable member is in the second state, the deformable member is configured to restrict flow through the conduit. In some implementations of the embodiments of the present apparatuses, the deformable member may be coupled to the connector body and/or may be configured to transition from the first state to the second state responsive to reduced-pressure applied to the first cavity. In a particular implementation, the first state comprises an undeformed state, and the second state comprises a deformed state. Additionally, or alternatively, the deformable member may include a porous structure, such as a foam (e.g., an open cell foam). In some implementations, the deformable member includes a through hole
configured to align with an opening of the conduit when the deformable member is in the first state.
[0011] In some of the foregoing embodiments of the present apparatuses, the first cavity may be configured to be open to an ambient atmospheric pressure when the deformable member is in the first state. In some implementations of the embodiments of the present apparatuses, when the deformable member is in the second state, the deformable member may be configured to restrict or prevent flow through the conduit.
[0012] In some of the foregoing embodiments of the present apparatuses, the connector further includes a cover layer, where the first cavity is further defined by the cover layer. In some implementations of the embodiments of the present apparatuses, the cover layer may be coupled to the connector body, the deformable member, or both. Additionally, or alternatively, the connector may further include a port configured to be coupled to a tube that includes one or more lumens. In some such implementations, the connector body may be coupled to the port. The port may be configured to be coupled to a reduced-pressure source via the tube. In a particular implementation, the port is integrally formed with the connector body.
[0013] In some of the foregoing embodiments of the present apparatuses, the connector may further include a spigot coupled to the connector body. In some such implementations, the spigot may extend at least partially through the port and/or includes at least a portion of the conduit. In some implementations, the connector body may be configured to define at least a portion of a second cavity. In some such implementations, the conduit may be configured to enable fluid communication between the second cavity and a first lumen of the one or more lumens. Additionally, or alternatively, the second cavity may include a cavity aperture at a first end of the connector body and/or the port may extend from a second end of the connector body. In such implementations, the connector body may be configured to be coupled to a tissue site via the first end of the connector body and/or may be configured to be coupled to a reduced- pressure source via the second end of the connector body.
[0014] In some of the foregoing embodiments of the present apparatuses, the conduit may include a first opening and a second opening. In some such implementations, the deformable member may be configured to block (and/or to cause blockage of) at least a portion of the first opening of the conduit to restrict the flow through the conduit. Additionally, or alternatively, the second opening of the conduit may be configured to be positioned within the first lumen of the one or more lumens. In some implementations, the connector is configured such that the second cavity includes a cavity aperture at a first end of the connector body and/or the port
extends from a second end of the connector body. In some such implementations, the connector body may be configured to be coupled to a tissue site via the first end of the connector body and to be coupled to a reduced-pressure source via the second end of the connector body.
[0015] In some of the foregoing embodiments of the present apparatuses, the connector may further include a base extending form a peripheral portion of the connector body associated with the cavity aperture (of the second cavity). Additionally, or alternatively, the port may include one or more lumen interfaces. In some such implementations, the connector may further include a channel extending between the second cavity and a lumen interface of the one or more lumen interfaces.
[0016] Some embodiments of the present apparatuses (e.g., of a dressing) comprise: a connector; and a drape coupled to the connector and configure to be coupled to a tissue site. The connector may include a connector as described above with reference to some embodiments of the present apparatuses (e.g., of a connector). For example, the connector may comprise a connector body configured to define at least a portion of a first cavity; a conduit coupled to the connector body; and a deformable member positioned within the first cavity and configured in a first state, wherein, when the deformable member is in a second state, the deformable member is configured to restrict a flow through the conduit.
[0017] In some implementations of the embodiments of the present apparatuses, the dressing may further include and/or be coupled to a tube that is coupled to the port of the connector. The tube may include one or more lumens. For example, in a particular implementation, the tube comprises multiple lumens including a primary lumen and one or more secondary lumens, such as one or more ancillary lumens (e.g., a sense lumen), one or more integrity lumens, or a combination thereof. Additionally, or alternatively, the dressing may include a manifold coupled to the connector, the drape, or both. In some such implementations, the manifold may include a foam.
[0018] Some embodiments of the present system (e.g., of a reduced-pressure system) comprise: a dressing; and a reduced-pressure source configured to be coupled to a connector via one or more tubes. The dressing may include a dressing as described above with reference to some embodiments of the present apparatuses (e.g., of a dressing). For example, the dressing may the connector; and a drape coupled to the connector and configured to be coupled to a tissue site. In some implementations of the embodiments of the present system, the connector may include a connector as described above with reference to some embodiments of the present apparatuses (e.g., of a connector).
[0019] Some embodiments of the present methods (e.g., of operation of a connector) comprise: coupling a dressing to a tissue site of a patient; coupling the dressing to a reduced- pressure source via one or more tubes; and providing, by the reduced-pressure source, reduced- pressure at the dressing. The dressing may include as described above with reference to some embodiments of the present apparatuses (e.g., of a dressing). In some of the foregoing embodiments of the present methods, the present methods further comprises, responsive to reduced-pressure provided to a first cavity of a connector of the dressing, deforming a deformable member positioned in the first cavity.
[0020] Some embodiments of the present methods (e.g., of operation of a reduced-pressure system) comprise: receiving reduced-pressure at a cavity of a connector; responsive to the reduced-pressure, deforming a deformable member positioned within the cavity; and blocking, based on the deformable member, at least a portion of an opening of a conduit of the connector. In some such implementations, the connector may include a connector as described above with reference to some embodiments of the present apparatuses (e.g., of a connector). For example, the connector may include a connector body configured to define at least a portion of a first cavity; a conduit coupled to the connector body; and a deformable member positioned within the first cavity and configured in a first state, wherein, when the deformable member is in a second state, the deformable member is configured to restrict a flow through the conduit.
[0021] Some embodiments of the present apparatuses (e.g., of a connector) comprise: a connector body configured to define at least a portion of a first cavity; a conduit coupled to the connector body; and a deformable member positioned within the first cavity and configured in a first state, wherein, when the deformable member is in a second state, the deformable member is configured to restrict flow through the conduit. For example, when the deformable member in the second state, the deformable member may be configured to restrict the flow through the conduit as compared to the deformable member configured in the first state. In some implementations of the embodiments of the present apparatuses, the deformable member may be coupled to the connector body and/or may be configured to transition from the first state to the second state responsive to reduced-pressure applied to the first cavity. In a particular implementation, the first state comprises an undeformed state, and the second state comprises a deformed state. Additionally, or alternatively, the deformable member may include a porous structure, such as a foam (e.g., an open cell foam). In some implementations, the deformable member includes a through hole configured to align with an opening of the conduit when the deformable member is in the first state.
[0022] Some embodiments of the present apparatuses (e.g., of a connector) comprise: a connector body configured to define at least a portion of a first cavity; and a deformable member configured to, responsive to reduced-pressure applied to the first cavity, deform to affect flow through the connector body. In some such implementations, the present apparatuses further comprise a conduit coupled to the connector body, and where the deformable member is configure to, responsive to reduced-pressure applied to the first cavity, deform to affect flow via the conduit In a particular implementation, the deformable member is configured to deform to restrict the flow through the connector body. In another particular implementation, the deformable member is configured to deform to prevent the flow through the connector body.
[0023] As used herein, various terminology is for the purpose of describing particular implementations only and is not intended to be limiting of implementations. For example, as used herein, an ordinal term (e.g.,“first,”“second,”“third,” etc.) used to modify an element, such as a structure, a component, an operation, etc., does not by itself indicate any priority or order of the element with respect to another element, but rather merely distinguishes the element from another element having a same name (but for use of the ordinal term). The term “coupled” is defined as connected, although not necessarily directly, and not necessarily mechanically. Additionally, two items that are“coupled” may be unitary with each other. To illustrate, components may be coupled by virtue of physical proximity, being integral to a single structure, or being formed from the same piece of material. Coupling may also include mechanical, thermal, electrical, communicational (e.g., wired or wireless), or chemical coupling (such as a chemical bond) in some contexts.
[0024] The terms“a” and“an” are defined as one or more unless this disclosure explicitly requires otherwise. The term“substantially” is defined as largely but not necessarily wholly what is specified (and includes what is specified; e.g., substantially 90 degrees includes 90 degrees and substantially parallel includes parallel), as understood by a person of ordinary skill in the art. As used herein, the term“approximately” may be substituted with“within 10 percent of’ what is specified. Additionally, the term“substantially” may be substituted with“within [a percentage] of’ what is specified, where the percentage includes .1, 1, or 5 percent; or may be understood to mean with a design, manufacture, or measurement tolerance. The phrase “and/or” means and or. To illustrate, A, B, and/or C includes: A alone, B alone, C alone, a combination of A and B, a combination of A and C, a combination of B and C, or a combination of A, B, and C. In other words,“and/or” operates as an inclusive or.
[0025] The terms “comprise” (and any form of comprise, such as “comprises” and
“comprising”),“have” (and any form of have, such as“has” and“having”), and“include” (and any form of include, such as“includes” and“including”). As a result, an apparatus that “comprises,”“has,” or“includes” one or more elements possesses those one or more elements, but is not limited to possessing only those one or more elements. Likewise, a method that “comprises,”“has,” or“includes” one or more steps possesses those one or more steps, but is not limited to possessing only those one or more steps.
[0026] Any aspect of any of the systems, methods, and article of manufacture can consist of or consist essentially of - rather than comprise/have/include - any of the described steps, elements, and/or features. Thus, in any of the claims, the term“consisting of’ or“consisting essentially of’ can be substituted for any of the open-ended linking verbs recited above, in order to change the scope of a given claim from what it would otherwise be using the open- ended linking verb. Additionally, it will be understood that the term“wherein” may be used interchangeably with“where.”
[0027] Further, a device or system that is configured in a certain way is configured in at least that way, but it can also be configured in other ways than those specifically described. The feature or features of one embodiment may be applied to other embodiments, even though not described or illustrated, unless expressly prohibited by this disclosure or the nature of the embodiments.
[0028] Some details associated with the aspects of the present disclosure are described above, and others are described below. Other implementations, advantages, and features of the present disclosure will become apparent after review of the entire application, including the following sections: Brief Description of the Drawings, Detailed Description, and the Claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0029] A further understanding of the nature and advantages of the present disclosure may be realized by reference to the following drawings. The following drawings illustrate by way of example and not limitation. For the sake of brevity and clarity, every feature of a given structure is not always labeled in every figure in which that structure appears. Identical reference numbers do not necessarily indicate an identical structure. Rather, the same reference number may be used to indicate a similar feature or a feature with similar functionality, as may non-identical reference numbers.
[0030] FIG. 1A is a perspective view of an example of a system for wound therapy;
[0031] FIG. IB is a cross-sectional view of an example of a tube taken along line A-A of
FIG 1A;
[0032] FIG. 2 is a cross-sectional view of an example of a connector;
[0033] FIG. 3 is a cross-sectional view of another example of the connector of FIG. 2;
[0034] FIG. 4 is a cross-sectional view of another example of the connector of FIG. 2;
[0035] FIG. 5 is a cross-sectional view of another example of the connector of FIG. 2;
[0036] FIG. 6 is a cross-sectional view of another example of a connector;
[0037] FIG. 7 is diagram of an example a system for wound therapy;
[0038] FIG. 8 is a flowchart illustrating an example of a method of operation of a connector; and
[0039] FIG. 9 is a flowchart illustrating an example of a method of operation of reduced- pressure system.
DETAILED DESCRIPTION
[0040] As used herein, the terms“tissue site” and“target tissue” as used herein can broadly refer to a wound (e.g., open or closed), a tissue disorder, and/or the like located on or within tissue, such as, for example, bone tissue, adipose tissue, muscle tissue, neural tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendons, ligaments, and/or the like. The terms“tissue site” and “target tissue” as used herein can also refer to a surrounding tissue area(s) and/or areas of tissue that are not necessarily wounded or exhibit a disorder, but include tissue that would benefit from tissue generation and/or tissue that may be harvested and transplanted to another tissue location. The terms“tissue site” and “target tissue” may also include incisions, such as a surgical incision. In some implementations,“target tissue” may correspond or refer to a wound, and“tissue site” may correspond or refer to a tissue area(s) surrounding and including the target tissue. Additionally, the term“wound” as used herein can refer to a chronic, subacute, acute, traumatic, and/or dehisced incision, laceration, puncture, avulsion, and/or the like, a partial-thickness and/or full thickness bum, an ulcer (e.g., diabetic, pressure, venous, and/or the like), flap, and/or graft. A wound may include chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness bums, ulcers (such as diabetic, pressure, or venous insufficiency ulcers), flaps, grafts, and fistulas, for example.
[0041] The term“reduced-pressure” (or“negative pressure”) as used herein generally refers to a pressure less than a local ambient pressure, such as the ambient pressure in a local environment external to a sealed therapeutic environment (e.g., an internal volume). In most cases, this reduced-pressure will be less than the atmospheric pressure at which the patient is
located. Alternatively, the reduced-pressure may be less than a hydrostatic pressure associated with tissue at the tissue site. Unless otherwise indicated, values of pressure stated herein are gauge pressures. References to increases in reduced-pressure typically refer to a decrease in absolute pressure, and decreases in reduced-pressure typically refer to an increase in absolute pressure. Additionally, the process of reducing pressure may be described illustratively herein as“applying”,“delivering,”“distributing,”“generating”, or“providing” reduced-pressure, for example.
[0042] The term“fluid” may refer to liquid, gas, air, or a combination thereof. The term “fluid seal,” or“seal,” means a seal adequate to maintain reduced-pressure at a desired site given the particular reduced-pressure source or subsystem involved. The term“downstream” typically implies something in a fluid path relatively closer to a reduced-pressure source, and conversely, the term“upstream” implies something relatively further away from a reduced- pressure source. Similarly, it may be convenient to describe certain features in terms of fluid “inlet” or“outlet” in such a frame of reference. However, the fluid path may also be reversed in some applications (such as by substituting a positive-pressure source for a reduced-pressure source) and this descriptive convention should not be construed as a limiting convention.
[0043] FIG. 1A shows a perspective view of an illustrative system 100 (e.g., a reduced- pressure system) for reduced-pressure therapy using reduced-pressure. System 100 (e.g., a reduced-pressure therapy system) may include a therapy device 110, a tube 114, and a dressing 116. System 100 is configured to provide reduced-pressure at a tissue site 120 associated with a target area of a patient. For example, dressing 116 may be in fluid communication with tissue site 120 and may be in fluid communication with therapy device 110 via tube 114. In some implementations, system 100 may include one or more components commercially available through and/or from KCI USA, Inc. of San Antonio, Tex., U.S.A., and/or its subsidiary and related companies (collectively,“KCI”).
[0044] Therapy device 110 (e.g., a reduced-pressure treatment apparatus) is configured to provide reduced-pressure via tube 114 and dressing 116. For example, therapy device 110 may include a reduced-pressure source, such as a vacuum source (e.g., a pump and/or the like), configured to be actuatable (and/or actuated) to apply reduced-pressure (e.g., negative pressure) to dressing 116. As illustrative, non-limiting examples, reduced-pressure applied to a tissue site may typically ranges between -5 millimeters mercury (mm Hg) (-667 pascals (Pa)) and -500 mm Hg (-66.7 kilo (k) Pa). Common therapeutic ranges are between -75 mm Hg (-9.9 kPa) and -300 mm Hg (-39.9 kPa). Therapy device 110 may also include one or
more other components, such as a sensor, a processing unit (e.g., a processor), an alarm indicator, a memory, a database, software, a display device, a user interface, and/or another component that further facilitate reduced-pressure therapy. Additionally, or alternatively, therapy device 110 may be configured to receive fluid, exudate, and or the like via dressing 116 and tube 114. Therapy device 110 may include one or connectors, such as a representative connector 138. Connector 130 is configured to be coupled to tube 114. Additionally, or alternatively, therapy device 110 may include one or more sensors, such a pressure sensor (e.g., a pressure transducer). The one or more sensors may be configured to enable therapy device 110 to monitor and/or sense a pressure associated with tube 114 and/or dressing 116. An illustrative example of therapy device 110 is described further herein at least with reference to FIG. 7.
[0045] As used herein, a“tube” broadly refers to a tube, pipe, hose, conduit, or other structure with one or more lumens adapted to convey fluid, exudate, and/or the like, between two ends. In some implementations, a tube may be an elongated, cylindrical structure with some flexibility; however, a tube is not limited to such a structure. Accordingly, tube may be understood to include a multiple geometries and rigidity. Tube 114 includes one or more lumens (e.g., one or more through conduits), such as a single lumen conduit or multiple single lumen conduits. Tube 114 (e.g., a least one of the one or more lumens) is configured to enable fluid communication between therapy device 110 and dressing 116. For example, fluid(s) and/or exudate can be communicated between therapy device 110 and dressing 116 and/or reduced-pressure (e.g., negative pressure) can be applied by therapy device 110 to dressing 116. Communication of fluid(s) and application of reduced-pressure can occur separately and/or concurrently.
[0046] In some implementations, tube 114 may include multiple lumens, such as a primary lumen (e.g., a reduce-pres sure/fluid lumen) for application of reduced-pressure and/or communication of fluid, and one or more secondary lumens proximate to or around the primary lumen. The one or more secondary lumens (e.g., one or more ancillary/peripheral lumens) may be coupled to one or more sensors (of therapy device 110), coupled to one or more valves, coupled to an end cap, and/or open to an atmosphere or an ambient environment, as illustrative, non-limiting examples. Although tube 114 is described as a single tube, in other implementations, system 100 may include multiple tubes, such as multiple distinct tubes coupled to therapy device 110, dressing 116, or both.
[0047] Referring to FIG. 1B, an illustrative example of a cross-section of tube 114 (when
tube 114 comprises a multiple lumens) along line A-A of FIG. 1A is shown. Tube 114 may include a primary lumen 121 (e.g., a reduce-pressure/fluid lumen) and one or more secondary lumens, such as a first secondary lumen 122 (e.g., an integrity lumen), a second secondary lumen 124 (e.g., a first sense lumen), a third secondary lumen 126 (e.g., a second sense lumen), and a fourth secondary lumen 128 (e.g., a third sense lumen). Although described as having four secondary lumens, in other implementations, tube 114 may include fewer than or more than four secondary lumens. Although tube 114 has been described and/or shown as having a circular cross-sectional shape, in other implementations, tube 114 may have a cross-sectional shape other than a circle, such as an oval, triangle, quadrilateral, pentagon, star, or another shape, as illustrative, non-limiting examples.
[0048] Referring to FIG. 1A, dressing 116 includes a connector 130 (also referred to as a dressing connection pad or a pad), a drape 132, and a manifold 134 (also referred to as a distribution manifold or an insert). Drape 132 may be coupled to connector 130. To illustrate, drape 132 may be coupled to connector 130 via an adhesive, a separate adhesive drape over at least a portion of connector 130 and at least a portion of drape 132, or a combination thereof, as illustrative, non-limiting examples.
[0049] Drape 132 may be configured to couple dressing 116 at tissue site 120 and/or to provide a seal to create an enclosed space (e.g., an interior volume) corresponding to tissue site 120. For example, drape 132 may be configured to provide a fluid seal between two components and/or two environments, such as between a sealed therapeutic environment and a local ambient environment. To illustrate, when coupled to tissue site 120, drape 132 is configured to maintain reduced-pressure (provided by a reduced-pressure source) at tissue site 120. Drape 132 may include a drape aperture that extends through drape 132 to enable fluid communication between device and target tissue, as describe further with reference to FIG. 7. Drape 132 may be configured to be coupled to tissue site 120 via an adhesive, such as a medically acceptable, pressure-sensitive adhesive that extends about a periphery, a portion, or an entirety of drape 132. Additionally, or alternatively, drape 132 may be coupled to tissue site 120 via a double-sided drape tape, paste, hydrocolloid, hydrogel, and/or other sealing device or element, as illustrative, non-limiting examples.
[0050] Drape 132 may include an impermeable or semi-permeable, elastomeric material, as an illustrative, non-limiting example. In some implementations, drape 132 may be liquid/gas (e.g., moisture/vapor) impermeable or semi-permeable. “Elastomeric” means having the properties of an elastomer. For example, elastomer generally refers to a polymeric material
that may have rubber-like properties. More specifically, an elastomer may typically have ultimate elongations greater than or equal to 100% and a significant amount of resilience. The resilience of a material refers to the material’s ability to recover from an elastic deformation. Elastomers that are relatively less resilient may also be used as these elastomers. Examples of elastomers may include, but are not limited to, natural rubbers, polyisoprene, styrene butadiene rubber, chloroprene rubber, polybutadiene, nitrile rubber, butyl rubber, ethylene propylene rubber, ethylene propylene diene monomer, chlorosulfonated polyethylene, polysulfide rubber, polyurethane (PET), EVA film, co-polyester, and silicones. In some implementations, drape 132 may include the“V.A.C.® Drape” commercially available from KCI. Additional, specific non-limiting examples of materials of drape 132 may include a silicone drape, 3M Tegaderm® drape, and a polyurethane (PU) drape such as one available from Avery Dennison Corporation of Pasadena, Calif. An additional, specific non-limiting example of a material of the drape 132 may include a 30 micrometers (pm) matt polyurethane film such as the Inspire"*^ 2317 manufactured by Exopack"^^ Advanced Coatings of Matthews, N.C.
[0051] Manifold 134 is configured to be positioned on and/or near tissue site 120, and may be secured at the tissue site 120, such as secured by drape 132. The term“manifold” as used herein generally refers to a substance or structure that may be provided to assist in applying reduced-pressure to, delivering fluids to, or removing fluids and/or exudate from a tissue site and/or target tissue. The manifold typically includes a plurality of flow channels or pathways that distribute fluids provided to and removed from the tissue site. In an illustrative implementation, the flow channels or pathways are interconnected to improve distribution of fluids provided to or removed from the tissue site. Manifold 134 may be a biocompatible material that may be capable of being placed in contact with the tissue site and distributing reduced-pressure to the tissue site. Manifold 134 may include, without limitation, devices that have structural elements arranged to form flow channels, such as foam, cellular foam, open cell foam, porous tissue collections, liquids, gels, and/or a foam that includes, or cures to include, flow channels, as illustrative, non-limiting examples. Additionally, or alternatively, manifold may include polyethylene, a polyolefin, a polyether, polyurethane, a co-polyester, a copolymer thereof, a combination thereof, or a blend thereof.
[0052] In some implementations, manifold 134 may be porous and may be made from foam, gauze, felted mat, or other material suited to a particular biological application. In a particular implementation, manifold 134 may be a porous foam and may include a plurality of
interconnected cells or pores that act as flow channels. The foam (e.g., foam material) may be either hydrophobic or hydrophilic. As an illustrative, non-limiting example, the porous foam may be a polyurethane, open-cell, reticulated foam such as GranuFoam® material manufactured by Kinetic Concepts, Incorporated of San Antonio, Tex.
[0053] In some implementations, manifold 134 may also be used to distribute fluids such as medications, antibacterials, growth factors, and other solutions to the tissue site. Other layers may be included in or on manifold 134, such as absorptive materials, wicking materials, hydrophobic materials, and hydrophilic materials. In an implementation in which the manifold 134 includes a hydrophilic material, manifold 134 may be configured to wick fluid away from tissue site 120 and to distribute reduced-pressure to tissue site 120. The wicking properties of manifold 134 may draw fluid away from the tissue site 120 by capillary flow or other wicking mechanisms. An illustrative, non-limiting example of a hydrophilic foam is a polyvinyl alcohol, open-cell foam such as V.A.C. WhiteFoam® dressing available from Kinetic Concepts, Inc. of San Antonio, Tex. Other hydrophilic foams may include those made from polyether and/or foams that have been treated or coated to provide hydrophilicity .
[0054] In some implementations, manifold 134 may promote granulation at the tissue site 120 if pressure within the sealed therapeutic environment is reduced. For example, one or more of the surfaces (e.g., any or all surfaces) of manifold 134 may have an uneven, coarse, or jagged profile that can induce microstrains and stresses at the tissue site 120 if reduced-pressure is applied through the manifold 134 to the tissue site 120.
[0055] In some implementations, manifold 134 may be constructed from bioresorbable materials that do not have to be removed from tissue site 120 following use of the system 100. Suitable bioresorbable materials may include, without limitation, a polymeric blend of polylactic acid (PLA) and polyglycolic acid (PGA). The polymeric blend may also include without limitation polycarbonates, polyfumarates, and capralactones. Manifold 134 may further serve as a scaffold for new cell-growth, or a scaffold material may be used in conjunction with manifold 134 to promote cell-growth. A scaffold may be a substance or structure used to enhance or promote the growth of cells or formation of tissue, such as a three- dimensional porous structure that provides a template for cell growth. Illustrative examples of scaffold materials include calcium phosphate, collagen, PLA/PGA, coral hydroxy apatites, carbonates, or processed allograft materials.
[0056] Connector 130 includes a body 142 (e.g., housing) and a base 144, and is configured to be coupled to tube 114 via an interface 146 (e.g., a port). Base 144 may be coupled, such as
via an adhesive, to drape 132 and/or manifold 134. In some implementations, base 144 may comprise a flange that is coupled to an end of body 142 and/or is integrally formed with body 142. Connector 130, such as body 142, base 144, interface 146, or a combination thereof, may be made of rigid material and/or a semi-rigid material. In a non-limiting example, connector 130 may be made from a plasticized polyvinyl chloride (PVC), polyurethane, cyclic olefin copolymer elastomer, thermoplastic elastomer, poly acrylic, silicone polymer, or polyether block amide copolymer. In some implementations, connector 130 may be formed of a semi rigid material that is configured to collapse when under a force, such as reduced-pressure less than or equal to a threshold pressure.
[0057] Body 142 includes one or more through channels, such as one or more conduits (e.g., channels) and/or one or more cavities that extend from and/or are coupled to interface 146. To illustrate, body 142 may include a primary channel configured to be coupled in fluid communication with a primary lumen (e.g., 121) of tube 114. The primary channel may be coupled to a cavity (of body 142) having an aperture open towards manifold 134 (and/or towards tissue site 120). For example, the primary channel may include a first opening associated with interface 146 and a second opening (distinct from the aperture of the cavity) associated with the cavity. Thus, the primary channel and the cavity may define a through channel of body 142 to enable fluid communication between interface 146 and tissue site 120.
[0058] Body 142 also includes a cavity 150 having an opening configured to be coupled to a secondary lumen (e.g., 122) of tube 114. A deformable member 152 is positioned within cavity 150 and configured to at least partially deform responsive to reduced-pressure applied to cavity 150. When reduced-pressure stops being applied to cavity 150, deformable member 152 may transition (e.g., expand) to a pre-collapsed state. Deformable member 152 may include a collapsible structure, such as a foam (e.g., open cell foam), porous structure (e.g., a sponge or sponge-type material), or an elastomer material. Deformable member 152 may be coupled to or encased in a cover layer (not shown), as described further with reference to FIG. 2. The cover layer may include a skin or coating configured to be coupled to or encase deformable member 152. For example, a skin, such as a material used for drape 132, may be formed around at least a portion of deformable member 152. Additionally, or alternatively, cover layer may be formed from a spay/sealer that includes a polymer to form a coating on an outer surface of deformable member 152. In some implementations, cavity 150 may be defined by body 142, the cover layer, or both.
[0059] Deformable member 152 and/or the cover layer may be coupled to a body 142. To
illustrate, deformable member 152 and/or the cover layer may be coupled to body 142 via an adhesive (e.g., glue, epoxy, etc.), RF welding, heat welding, ultrasonic welding, or insert molded, as illustrative, non-limiting examples.
[0060] When cavity 150 is coupled to a first end of the secondary lumen (e.g., 122), while the second end of the secondary lumen is coupled to an end cap or to an ambient environment, deformable member 152 maintains an undeformed state (e.g., a first state) in which fluid communication via the primary channel and/or the primary lumen (e.g., 121) is unobstructed/unrestricted. However, if connector 130 is coupled in such a manner that reduced -pressure is applied to cavity 150, deformation of deformable member 152 occurs to cause a reduction in a volume of cavity 150. When deformable member 152 is in a deformed state (e.g., a second state), deformable member 152 is configured to cause fluid communication via the primary channel and/or the primary lumen (e.g., 121) to be restricted and/or prohibited, as described further herein with reference to at least FIGS. 2-5. Illustrative, non-limiting examples of commercially available connectors into which cavity 150 and deformable member 152 can be incorporated include a“V.A.C. T.R.A.C.® Pad,” or“Sensa T.R.A.C.® Pad” available from Kinetic Concepts, Inc. (KCI) of San Antonio, Tex.
[0061] In some implementations, the one or more through channels (e.g., the one or more conduits and/or the one or more cavities of body 142) may include a secondary channel configured to be coupled in fluid communication with a secondary lumen (e.g., 124, 126, 128). The secondary channel may define at least a portion of a through channel of body 142. Additionally, or alternatively, in some implementations, body 142 may include or define channel elements positioned near and in fluid communication with the aperture of the cavity coupled to the primary lumen (e.g., 121) of tube 114. The channel elements may be configured to direct fluid(s), exudate, and/or another material toward the cavity and the primary channel of body 142. The routing of fluid(s) toward the primary channel maintains one or more secondary channels (e.g., secondary lumens) open/unobstructed for other purposes, such as pressure measurements.
[0062] During operation of system 100, dressing 116 is coupled to tissue site 120. Additionally, dressing 116 is coupled to device 110 via tube 114. Reduced-pressure can be applied to dressing 116 (e.g., an interior volume of dressing 116) by a reduced-pressure source associated with device 110. If device 110 is coupled to dressing 116 such that reduced-pressure is not provided to cavity 150, deformable member 152 maintains an undeformed state (e.g., the first state) in which fluid communication via the primary channel and/or the primary lumen
(e.g., 121) is unobstructed/unrestricted. In such situations, exudate, fluid, and/or another material to be drawn (e.g., removed) from tissue site 120 via the primary lumen 121 of tube 114 (e.g., the reduced-pressure/fluid lumen). Alternatively, if device 110 is coupled to a reduced -pressure source such that reduced-pressure is provided to cavity 150, deformation of deformable member 152 occurs to cause a reduction in a volume of cavity 150. When deformable member 152 is in a deformed state (e.g., a second state), deformable member 152 is configured to cause fluid communication via the primary channel and/or the primary lumen (e.g., 121) to be restricted and/or prohibited. Additionally, by deformable member 152 reducing/limiting the amount of reduced-pressure at the tissue site 120, excess reduced- pressure at tissue site 120 may be avoided.
[0063] In a particular implementation, dressing 116 includes connector 130 and drape 132 coupled to the connector 130 and is configured to be coupled to tissue site 120. Connector 130 may include body 142 (e.g., a connector body) configured to define at least a portion of a first cavity (e.g., 150). Connector 130 may also include a conduit coupled to (or defined by) body 142. Deformable member 152 may be configured to be transitionable between a first state and a second state, where, when the deformable member is in a first state, deformable member 152 is configured to allow (e.g., enable) flow through the conduit, and when deformable member 152 is in the second state, deformable member 152 is configured to restrict flow through the conduit. For example, deformable member 152 may be positioned within the cavity (e.g., 150) and be configured in a first state (when exposed to ambient pressure). When deformable member 152 is in a second state, such as when exposed to reduced-pressure, deformable member 152 is configured to restrict a flow through the conduit. For example, when deformable member 152 in the second state, deformable member 152 may be configured to restrict the flow through the conduit as compared to when deformable member 152 is configured in the first state.
[0064] In some implementations, connector 130 includes connector body 142 configured to define at least a portion of a first cavity (e.g., 150); and deformable member 152 configured to, responsive to reduced-pressure applied to the first cavity, deform to affect flow through the connector body 142. In some such implementations, the connector includes a conduit coupled to the connector body 142, and deformable member 152 is configure to, responsive to reduced- pressure applied to the first cavity (e.g., 150), deform to affect flow via the conduit.
[0065] Thus, connector 130 (e.g., cavity 150 and deformable member 152) is configured to restrict and/or prohibit a flow path to reduce or limit an amount of reduced-pressure at the tissue
site when reduced-pressure is provided to cavity 150. For example, if connector 130 and/or tube 114 is modified, or if one or more features (e.g., safety features) of system 100 are bypassed, cavity 150 may be coupled to a reduced-pressure source (e.g., a wall-vacuum port) such that reduced-pressure is provided to cavity 150. If reduced-pressure may be applied to cavity 150, deformable member 152 may deform to cause blockage of one or more conduits/channels of connector 130, thereby avoiding or limiting excess reduced-pressure and/or fluid or exudate removal at tissue site 120. Additionally, blocking one or more conduits/channels of the connector 130 may deter and/or prevent intentionally or accidentally modification and/or bypassing of one or more components/features of system 100 (e.g., the reduced -pressure therapy system). Accordingly, cavity 150 and/or deformable member 152 may enable effective, efficient, and safe reduced-pressure therapy through use of system 100, thereby advancing patient reliability and confidence in the treatment.
[0066] Referring to FIGS. 2-5, examples of a connector 230 are shown. For example, connector 230 may include or correspond to connector 130. Connector 230 is configured to be incorporated in or coupled to a dressing, such as a dressing of a reduced-pressure system. For example, the dressing may include or correspond to dressing 116 of system 100.
[0067] Referring to FIG. 2, an example of a cross-section view of connector 230 is shown. Connector 230 includes a connector body 242 (e.g., housing), a base 244, an interface 246 (e.g., a port), and a spigot 270. Connector body 242 may include or correspond to body 142. Base 244 and interface 246 may include or correspond to base 144 and interface 146. Connector 230 may include a first end 247 that corresponds to base 244 and a second end 248 that corresponds to interface 246. Connector 230 (e.g., connector body 242) may be configured to be coupled to a tissue site (e.g., 120) via first end 247 of body 242 and may be configured to be coupled to a reduced-pressure source via second end 248 of body 242.
[0068] Connector 230 is configured to be coupled to a tube (not shown in FIG. 2) via interface 246. For example, interface 246 be sized to be coupled to a tube, as described with reference to FIG. 3. As shown in FIG. 2, interface 246 includes a ridge 249 that may contact an end of the tube. Although connector 230 is described as including ridge 249, in other implementations, connector 130 (e.g., interface 246) may not include ridge 249.
[0069] Body 242 may define at least a portion of one or more cavities, such as a first cavity 250 into which a deformable member 252 is positioned, and a second cavity 254. Cavity 250 and deformable member 252 may include or correspond to cavity 150 and deformable member 152, respectively. Cavity 250 may have an opening 257 that corresponds to interface 246. The
opening 257 may be configured to be coupled to a lumen (e.g., an integrity lumen) of a tube coupled to interface 246.
[0070] Deformable member 252 may be coupled to or encased in a cover layer 260, as described with reference to FIG. 1. Accordingly, cavity 250 may be defined by body 242 and the cover layer 260. Cover layer 260 may be coupled to body 242, deformable member 252, or both. In some implementations, deformable member 252 is coupled to body 242 via cover layer 260 and is not directly coupled to body 242 At least a portion 255 of deformable member 252 is not covered or encased by cover layer 260.
[0071] Second cavity 254 includes a cavity aperture 266 at first end 247 of connector body 242. Cavity aperture 266 may be defined by base 244, which extends form a peripheral portion of connector body 242, such as a portion of body 242 adjacent to the cavity aperture 266 (of second cavity 254).
[0072] Spigot 270 is coupled to body 242 and may extend at least partially through interface 246. Spigot 270 includes a conduit 272 having a first opening 274 and a second opening 276. Spigot 270 is configured to be inserted into a primary lumen (e.g., a reduce-pres sure/fluid lumen) of a tube coupled to connector 230 such that conduit 272 is in fluid communication with the primary lumen. Conduit 272 may be configured to enable fluid communication between second cavity 254 and the primary lumen (e.g., a reduce-pres sure/fluid lumen) of a tube.
[0073] Deformable member 252 and/or cover layer 260 may include a through hole 262 and may be positioned to enable fluid communication between second cavity 254 and a reduced- pressure source via conduit 272. For example, when deformable member 252 is exposed to ambient pressure, as shown in FIG. 2, deformable member 252 is in a first state (e.g., an undeformed state) and is configured to enable fluid communication between second cavity 254 and a reduced-pressure source via conduit 272. Responsive to reduced -pres sure applied to cavity 250, deformable member 252 is configured to deform to at least partially restrict fluid communication between second cavity 254 and a reduced-pressure source via conduit 272, as described further herein with reference to FIG. 4.
[0074] In some implementations, body 242 may include one or more conduits (e.g., channels) in addition to conduit 272. For example, body 242 may include a channel 280 in fluid communication with second cavity 254. Additionally, channel 280 may be in fluid communication with an opening 282 that corresponds to interface 246. The opening 282 may be configured to be coupled to a lumen (e.g., a sense lumen) of a tube coupled to interface 246.
[0075] Referring to FIG. 3, another example of a cross-section view of connector 230 is shown. As shown, connector 230 is coupled to a tube 314 (e.g., a multi-lumen tube). A first end of tube 314 is coupled to interface 246 (e.g., is in contact with ridge 249) and a second end of tube 314 is configured to be coupled to a reduce pressure source (e.g., device 110). In some implementations, interface 246 and tube 314 are coupled together to form a seal. For example, interface 246 and tube 314 may be coupled via a binder (e.g., an adhesive and/or a solvent) that forms a bond or weld between interface 246 and tube 314.
[0076] Tube 314 includes a primary lumen 321 (e.g., a reduced-pressure/fluid lumen) and one or more secondary lumens, such as a first secondary lumen 322 (e.g., an integrity lumen) and a second secondary lumen 328 (e.g., a sense lumen). Although described as having two secondary lumens, in other implementations, tube 314 may include a single secondary lumen (e.g., an integrity lumen) or more than two secondary lumens. For example, FIG. 6 describes an example of a connector configured to be coupled to a multiple lumen tube including a single primary lumen and a single secondary lumen.
[0077] Primary lumen 321 may be coupled to spigot 270 such that conduit 272 enables fluid communication between second cavity 254 and a reduced-pressure source. Reduced-pressure may be provided to second cavity 254 via primary lumen 321. Spigot 270 may be coupled to (attached) and/or integrally formed with a wall of connector 230. Spigot 270 may be inserted into primary lumen 321 and may deform a portion of primary lumen 321 to form a seal with primary lumen 321. For example, second opening 276 of conduit 272 may be configured to be positioned within primary lumen 321. In some implementations, spigot 270 may be coupled to a surface (e.g., a bore) of primary lumen 321 to form a seal. Additionally, or alternatively, spigot 270 and primary lumen 321 may be coupled via a binder (e.g., an adhesive and/or a solvent) that forms a bond or weld between spigot 270 and primary lumen 321.
[0078] First secondary lumen 322 (e.g., integrity lumen) is configured to be coupled to opening 257 such that first secondary lumen 322 (e.g., integrity lumen) is in fluid communication with first cavity 250. For example, opening 257 may correspond to a first lumen interface of multiple lumen interfaces of interface 246 (e.g., a port). First secondary lumen 322 (e.g., integrity lumen) and first cavity 250 may be configured to be isolated from reduced-pressure provided via primary lumen 321 to second cavity 254. For example, first secondary lumen 322 (e.g., integrity lumen) and first cavity 250 may be maintained at an ambient pressure when reduced-pressure is provided via primary lumen 321 to second cavity 254. While at the ambient pressure, deformable member 252 may be in a first state (e.g., an
undeformed state) and may not cause blockage of a flow path between second cavity 254 and primary lumen 321 (e.g., a flow path that includes second cavity 254, conduit 272, and primary lumen 321). To illustrate, when deformable member 252 is in the first state, through hole 262 of deformable member 252 (and cover layer 260) may be configured to align with an opening of conduit 272 such that a flow path is unobstructed by deformable member 252 and/or cover layer 260. Although deformable member 252 (and cover layer 260) are described as being positioned at an end of conduit 272, in other implementations, deformable member 252 (and cover layer 260) may be positioned between openings 274, 276, such that deformable member 252 (and cover layer 260) are in-line with respect to conduit 272.
[0079] Second secondary lumen 328 (e.g., sense lumen) is configured to be coupled to opening 282 such that second secondary lumen 328 (e.g., sense lumen) is in fluid communication with second cavity 254. For example, opening 282 may correspond to a second lumen interface of multiple lumen interfaces of interface 246 (e.g., a port). Second secondary lumen 328 (e.g., sense lumen) may be in fluid communication with second cavity 254 to enable a sensor coupled to second secondary lumen 328 to monitor a pressure associated with second cavity 254. To illustrate, channel 280 extends between second cavity 254 and the lumen interface.
[0080] Referring to FIG. 4, another example of connector 230 is shown. As shown, tube 314 has been cut and coupled to a second tube 414 having a single lumen 421. Tube 414 may be coupled to a reduced-pressure source, such as wall suction, or a therapy device that is not configured with pressure sensing/monitoring features and/or safety features. Reduced-pressure provided via the single lumen 421 may be provided via tube 314, such as via each of primary lumen 321 (e.g., a reduce-pres sure/fluid lumen), first secondary lumen 322 (e.g., an integrity lumen), and second secondary lumen 328 (e.g., a sense lumen).
[0081] As shown, deformable member 252 is in the second state (e.g., the deformed state) responsive to reduced-pressure provided to first cavity 250. For example, deformable member 252 may be constricted such that through hole 262 is at least partially closed or closed as compared to when the deformable member is in the first state. Accordingly, a flow path from second cavity to primary lumen 321 via conduit 272 is at least partially blocked by deformable member 252 (and/or cover layer 260) as compared to when the deformable member is in the first state.
[0082] It is noted that when reduced pressure is provided to first cavity 250 and deformable member 252 is in the second state, reduced-pressure may be provided to second cavity 254 via
second secondary lumen 328 (and channel 280). In such a situation, a flow path may be present from second cavity to the single lumen 421 via channel 280. Diameters of second secondary lumen 328 and channel 280 are smaller than diameters of primary lumen 321 and conduit 272, respectively. Accordingly, reduced-pressure may be provided, and fluid and/or exudate removal, may occur via channel 280; however, such reduced pressure and removal may be at a slow rate as compared to reduced-pressure provided, and fluid and/or exudate removal, via conduit 272 when deformable member 252 is in the first state. Because fluid is removed at a slower rate and/or because reduced-pressure is established at a slower rate, an effectiveness of connector 230 (e.g., a dressing that includes connector 230) is diminished when the dressing has been modified and/or when one or more features has been bypassed. The diminished effectiveness operates as a deterrent to modification of the dressing and/or bypassing one or more features.
[0083] Referring to FIG. 5, another example of misuse of connector 230 is shown. FIG. 5 shows a cross-section of connector 230 that is coupled to a tube 514 having a single lumen 521. Tube 514 may be coupled to a reduced-pressure source, such as wall suction, or a therapy device that is not configured with pressure sensing/monitoring features and/or safety features. According, reduced-pressure provided via the single lumen 521 may also be provided to connector 230. As described with reference to FIG. 4, responsive to reduced-pressure provided to first cavity 250, deformable member 252 is in the second state (e.g., the deformed state). Accordingly, a flow path from second cavity to primary lumen 521 via conduit 272 is blocked by deformable member 252 (and/or cover layer 260). Thus, when connector 230 is directly connected to the tube 514, connector 230 including deformable member 252 provides the same functionality to restrict or prohibit a flow path via conduit 272 as when a multi-lumen tube (e.g., 314) is cut and when a single lumen tube 514 is connected to interface 246.
[0084] Referring to FIG. 6, an example of a cross-section view of connector 630 is shown. Connector 630 includes a connector body 642 (e.g., housing), a base 644, an interface 646 (e.g., a port), and a spigot 670. Connector body 642 (e.g., a housing) may include or correspond to body 142 or body 242. Base 644 may include or correspond to base 144 or base 244. Interface 646 may include or correspond to interface 146 or interface 246. Connector 630 may include a first end 647 that corresponds to base 644 and a second end 648 that corresponds to interface 646. Connector 630 (e.g., connector body 642) may be configured to be coupled to a tissue site (e.g., 120) via first end 647 of body 642 and may be configured to be coupled to a reduced- pressure source via second end 648 of body 642. For example, connector 630 is configured to
be coupled to a tube 614 via interface 646. For example, interface 646 be sized to be coupled to tube 614. Tube 614 includes a primary lumen 621 (e.g., a reduce-pres sure/fluid lumen) and a secondary lumen 622 (e.g., an integrity lumen).
[0085] Body 642 may define at least a portion of one or more cavities, such as a first cavity 650 into which a deformable member 652 is positioned, and a second cavity 654. Cavity 650 may include or correspond to cavity 150 or cavity 250. Deformable member 652 may include or correspond to deformable member 152 or deformable member 252. Deformable member 652 may be coupled to or encased in a cover layer 660, such as cover layer 260. Accordingly, cavity 650 may be defined by body 642 and cover layer 660. Cavity 650 may have an opening 657 that corresponds to interface 646. The opening 657 may be configured to be coupled to a lumen (e.g., an integrity lumen) of tube 614.
[0086] Second cavity 654 includes a cavity aperture 665 at first end 647 of connector body 642. Cavity aperture 665 may be defined by base 644, which extends form a peripheral portion of connector body 642 adjacent to the cavity aperture 665 (of second cavity 654).
[0087] Spigot 670 is coupled to body 642 and may extend at least partially through interface 646. Spigot 670 includes a conduit 672. Conduit 672 may include or correspond to conduit 272. Primary lumen 621 may be coupled to spigot 670 such that conduit 672 enables fluid communication between second cavity 654 and a reduced-pressure source. Reduced-pressure may be provided to second cavity 654 via primary lumen 621. Spigot 670 may be coupled to (attached) and/or integrally formed with a wall of connector 630 (e.g., body 642). Spigot 670 may be inserted into primary lumen and to form a seal.
[0088] Deformable member 652 and/or cover layer 660 may include a through hole 662 and may be positioned to enable fluid communication between second cavity 654 and a reduced- pressure source via conduit 672. To illustrate, through hole 662 of deformable member 652 (and cover layer 660) may be configured to align with an opening of conduit 672 when deformable member 652 is in the first state. Secondary lumen 622 (e.g., integrity lumen) is configured to be coupled to opening 657 such that first secondary lumen 622 (e.g., integrity lumen) is in fluid communication with first cavity 650. For example, opening 657 may correspond to a first lumen interface of multiple lumen interfaces of interface 646 (e.g., a port).
[0089] Secondary lumen 622 (e.g., integrity lumen) and first cavity 650 may be configured to be isolated from reduced-pressure provided via primary lumen 621 to second cavity 654. To illustrate, secondary lumen 622 (e.g., integrity lumen) and first cavity 650 may be maintained at an ambient pressure when reduced-pressure is provided via primary lumen 621 to second
cavity 654. While at the ambient pressure, deformable member 652 may be in a first state (e.g., an undeformed state) and may not cause blockage of a flow path between second cavity 654 and primary lumen 621. When deformable member 652 is exposed to ambient pressure, deformable member 652 is in a first state (e.g., an undeformed state) and is configured to enable fluid communication between second cavity 654 and a reduced-pressure source via conduit 672. Responsive to reduced-pressure applied to cavity 650, deformable member 652 is configured to deform to at least partially fluid communication between second cavity 654 and a reduced-pressure source via conduit 672. Additionally, blocking one or more conduits/channels of the connector 630 may deter and/or prevent intentionally or accidentally modification and/or bypassing of one or more components/features of a reduced therapy system. Accordingly, cavity 650 and/or deformable member 652 may enable effective, efficient, and safe reduced-pressure therapy through use of the reduced-therapy system, thereby advancing patient reliability and confidence in the treatment.
[0090] Referring to FIG. 7, an illustrative example of an illustrative system 700 (e.g., reduce-pressure therapy system) is shown. System 700 includes a reduced-pressure therapy device 710 (e.g., a reduced-pressure therapy apparatus), a tube 714, and a dressing 716. Dressing 716 is coupled to device 710 via tube 714. Device 710 and dressing 716 may include or correspond to device 110 and dressing 116, respectively. Tube 714 may include or correspond to tube 114, tube 314, tube 414, tube 514, or tube 614.
[0091] Dressing 716 is configured to be coupled to (e.g., adhered to) a tissue site 720 of a patient. Tissue site 720 may include or correspond to tissue site 120. Dressing 716 may include one or more components, such as a connector 730, a drape 732, a manifold 734, or a combination thereof, as illustrative, non-limiting examples. Connector 730 may include or corresponds to connector 130, connector 230, or connector 630. Drape 732 and manifold 734 may include or correspond to drape 132 and manifold 134, respectively. Drape 732 may be coupled to connector 730 and/or manifold 734, and may include an opening 735 (e.g., a drape aperture) to enable communication (e.g., fluid communication) between connector 730 and manifold 734.
[0092] As shown, drape 732 is coupled to tissue site 720 via a representative adhesive 737, such as a medically acceptable, pres sure- sensitive adhesive that extends about a periphery, a portion, or an entirety of drape 132. Additionally, or alternatively, drape 732 may be coupled to tissue site 720 via a double-sided drape tape, paste, hydrocolloid, hydrogel, and/or other sealing device or element, as illustrative, non-limiting examples. Drape 732 is configured to
be coupled to tissue site 720 such that drape 732 covers manifold 734 (and target tissue 736) to form and/or define an interior volume 738 between drape 732 and tissue site 720 (e.g., target tissue 736). To illustrate, interior volume 738 may correspond to a sealed therapeutic environment. For example, the tissue proximate the target tissue 736 may be undamaged epidermis peripheral to target tissue 736. The sealed therapeutic environment may be isolated from an external environment, such as an external environment at ambient pressure.
[0093] As shown, manifold 734 is positioned within interior volume 738 at (e.g., on or above) target tissue 736 of tissue site 720. In some implementations, manifold 734 may contact tissue site 720, target tissue 736, or both. In some implementations, such as when target tissue 736 extends into tissue from a tissue surface 722 creating a cavity, manifold 734 may partially or completely fill the cavity. In other implementations, manifold 734 may be placed over target tissue 736. Manifold 734 may take one or more forms, and/or may have one or more configurations (e.g., sizes, shapes, and/or thicknesses), depending on one or more factors, such as the type of treatment being implemented, the nature and size of target tissue 736, a stage of treatment, or a combination thereof. For example, the size and shape of the manifold 734 may be adapted to target tissue 736 and/or tissue site 720. To illustrate, manifold 734 may be adapted to a contours of target tissue 736 and/or tissue site 720. In a particular implementation, manifold 734 includes a foam, such as GranuFoam® material manufactured by Kinetic Concepts, Incorporated of San Antonio, TX, as an illustrative, non-limiting example.
[0094] Connector 730 may include a connector body 742, a base 744, and an interface 746 (e.g., a port). Connector body 742 (e.g., a housing) may include or correspond to body 142, body 242, or body 642. Base 744 may include or correspond to base 144, base 244, or base 644. Interface 746 may include or correspond to interface 146, interface 246, or interface 646. Interface 746 is configured to be coupled to tube 714.
[0095] Body 742 may define one or more cavities, such as a cavity 750 (e.g., a first cavity) into which a deformable member 752 is positioned. Cavity 750 may include or correspond to cavity 150, cavity 250, or cavity 650. The deformable member 752 may include or correspond to deformable member 152, deformable member 252, or deformable member 652. As described further herein, deformable member 752 is configured to at least partially deform responsive to reduced-pressure applied to cavity 750. In some implementations, deformable member 752 may include or be coupled to a cover layer, such as cover layer 260, 660.
[0096] Additionally, body 742 may include one or more through channels, such as one or more conduits (e.g., channels) and/or one or more additional cavities (e.g., a second cavity),
that extend from and/or are coupled to interface 146. For example, body 742 may include a conduit and a second cavity that are in fluid communication with interior volume 738. To illustrate, the second cavity may have an aperture defined by base 744, and which is positioned over manifold 734, to enable fluids and/or exudate to be are drawn from target tissue 736. In some implementations, connector 730 may be positioned on manifold 734 such that a perimeter of the aperture (defined by base 744) is in direct contact with manifold 734. When the conduit (e.g., 272, 672) and the second cavity (e.g., 254, 654) are in fluid communication with interior volume 738, connector 730 may operate to maintain fluid communication between interior volume 738 and device 710 via tube 714, and to prevent fluid communication between interior volume (e.g., a sealed therapeutic environment formed by dressing 716) and the ambient environment.
[0097] Referring to cavity 750 and deformable member 752, deformable member 752 is configurable in a first state (e.g., an undeformed state) and in a second state (e.g., a deformed state). In the first state (e.g., the undeformed state), deformable member 752 is configured and/or positioned to enable reduced-pressure to be communicated via the conduit and/or the second cavity. When deformable member 752 is in the second state, deformable member 752 (and/or the cover layer) is configured to at least partially restrict and/or block a flow path through the conduit and/or the second cavity. For example, deformable member 752 may transition (e.g., constrict) from the first state to the second state responsive to reduced-pressure applied to cavity 750, thereby causing a portion of the cover layer (e.g., 260, 660) to at least partially block an opening of the conduit and/or the second cavity.
[0098] Tube 714 includes one or more lumens. For example, tube 714 may include a reduce-pressure/fluid lumen (e.g., 120), an integrity lumen (e.g., 122), a first sense lumen (e.g., 124), and a second sense lumen (e.g., 126). As shown, a first end of tube 714 is coupled to dressing 716 and a second end of tube 714 is coupled to device 710. In some implementations, the second end of tube 714 may include a therapy device connector configured to couple (e.g., mate) with device 710.
[0099] Device 710 includes a controller 760, one or more interfaces 762, one or more I/O devices 764, and one or more connectors, such as a representative connector 766. Device 710 further includes one or more conduits 768, a fluid chamber 770, pressure sensors 772, 774, one or more valves 776 (e.g., solenoid valves), and a reduced-pressure source 778.
[00100] Connector 766, such as connector 138, is configured to be coupled to tube 714, such as the second end of tube 714. Connector 766 includes one or more port/interfaces, such as a
first port/interface 780, a second port/interface 782, a third port/interface 784, a fourth port/interface 786. When connector 766 is coupled to tube 714, the reduce-pressure/fluid lumen (e.g., 120) is in fluid communication with second port/interface 782, integrity lumen (e.g., 122) is in fluid communication with first port/interface 780, first sense lumen (e.g., 124) is in fluid communication with third port/interface 784, and second sense lumen (e.g., 126) is in fluid communication with fourth port/interface 786. First port/interface 780 may include or be coupled to an endcap or wall, or may be open to an ambient environment (e.g., ambient pressure).
[00101] Each of second port/interface 782, third port/interface 784, and fourth port/interface 786 is coupled to one or more components of device 710 via one or more conduits (e.g., 768). For example, second port/interface 782 is coupled through fluid chamber 770 (e.g., a canister) to reduced-pressure source 778, third port/interface 784 is coupled to a first pressure sensor 772, and fourth port/interface 786 is coupled to a second pressure sensor 774. The sensors 772, 774 may be configured to generate data indicative of pressure within dressing 716. Although described as having two pressure sensors (e.g., 772, 774), in other implementations, device 710 may include fewer than two pressure sensors, such as no pressure sensors or a single pressure sensor, or more than two pressure sensors.
[00102] Additionally, each of second port/interface 782, third port/interface 784, and fourth port/interface 786 is coupled to a corresponding valve (e.g., 776), such as a solenoid valve, which is configured to change pressure from dressing 716. Second port/interface 782 is coupled to reduced-pressure source 778 and a corresponding valve 776 via fluid chamber 770 (e.g., a liquid-collection chamber).
[00103] Reduced-pressure source 778 is configured to provide reduced-pressure to interior volume 738 of dressing 716 such that interior volume 738 is reduced, and/or reduced-pressure is applied to at least target tissue 736. Reduced-pressure source 778 may include a mechanically and/or electrically-powered device, such as a manually-actuated or manually- charged pump, a vacuum pump, an electrically-driven vacuum pump, a suction pump, a wall suction port, a micro-pump, a disc-pump, and/or the like, as illustrative, non-limiting examples.
[00104] Controller 760 includes a processor 790 coupled to a memory 792 (e.g., a computer- readable storage device). Memory 792, such as a non-transitory computer-readable storage medium, may include volatile memory devices (e.g., random access memory (RAM) devices), nonvolatile memory devices (e.g., read-only memory (ROM) devices, programmable read-only memory, and flash memory), or both. Memory 792 may be configured to store instructions
794, a pressure profile 796, and one or more thresholds 798. Instructions 794 may be configured to, when executed by the one or more processors 790, cause the processor(s) 790 to perform one or more operations.
[00105] Pressure profile 796 may include desired target pressures to be provided to a patient over a time period. In some implementations, the pressure profile 796 may include a set-up profile applying target pressures at the commencement of therapy treatments and a maintenance profile for applying target pressure during therapy. One or more thresholds 798 may include one or more one or more pressure thresholds, one or more time thresholds, one or more other thresholds, or a combination thereof.
[00106] Processor 790 may include a microcontroller/microprocessor, a central processing unit (CPU), a field-programmable gate array (FPGA) device, an application-specific integrated circuits (ASIC), another hardware device, a firmware device, or any combination thereof. Processor 790 may be configured to execute instructions 794, execute and/or operate according to pressure profile 796, and / process sensor data generate by sensors 772, 774. For example, processor 790 may be configured to process sensor data (e.g., pressure signals) received by one or more sensors (e.g., 772, 774) and/or monitor the sensor data. Additionally, or alternatively, processor 790 may be configured to issue one or more alerts according to a pre-determined pressure therapy (e.g., pressure profile 796) for a patient and/or based on one or more thresholds 798. In some implementations, the one or more alerts may be in the form of a visual alert (e.g., a light indicator), a tactile alert, an audible alert, a message presented via a display, or a message transmitted to another device. In the event that processor 790 determines that pressure profile 796 is being implemented, processor 790 may provide an indication that the sensor data (e.g., the monitored pressure at dressing 716) is following pressure profile 796. For example, processor 790 may initiate a visual indication (e.g., a light indicator), a tactile indication, an audible indication, a message presented via a display, or a message transmitted to another device.
[00107] The one or more interfaces 762 may include a wired interface, a wireless interface, or both. In some implementation, the one or more interfaces 762 may include a network interface and/or a device interface configured to be communicatively coupled to one or more other devices. For example, interfaces 762 may include a transmitter, a receiver, or a combination thereof (e.g., a transceiver), and may enable wired communication, wireless communication, or a combination thereof. Additionally, or alternatively, the one or more interfaces 762 may include serial interfaces (e.g., universal serial bus (USB) interfaces or
Institute of Electrical and Electronics Engineers (IEEE) 1394 interfaces), parallel interfaces, display adapters, audio adapters, and other interfaces The one or more I/O devices 764 may include a mouse, a keyboard, pointing devices, a display device, the camera, speakers, microphones, touch screens, other I/O devices, or a combination thereof. Processor 790 may configured to send and/or receive data via the interface(s) 762 and/or the I/O device(s) 764.
[00108] During operation, dressing 716 is coupled to tissue site 720 so as to cover target tissue 736. Additionally, dressing 716 is coupled to device 710 via tube 714. In some implementations, processor 790 receives an input via I/O device 764, such as a touchscreen, to select a pressure profile (e.g., 796) of multiple pressure profiles stored at memory 792, to initiate reduced-pressure therapy, or both. Alternatively, the input may indicate a value of a reduce-pressure to be provided and/or maintained. Responsive to the input, controller 760 (e.g., processor 790) generates one or more commands to initiate operations of one or more components of device 710. For example, processor 790 may access pressure profile 796 (e.g., a set-up profile or a maintenance profile). Additionally, or alternatively, processor 790 may activate and/or regulate reduced-pressure source 778, one or more valves 776, or both. In some implementations, processor 790 may control operation of reduced-pressure source 778, one or more valves 776 based on at least in part on the input (e.g., the pressure profile 796 selection or the value of the reduced-pressure).
[00109] Responsive to one or more signals (e.g., commands) from processor 790, reduced- pressure source 778 may apply reduced-pressure to dressing 716. For example, reduced- pressure developed by reduced-pressure source 778 may be delivered through tube 714 to connector 730 of dressing 716. Accordingly, the reduced-pressure source 778 can reduce a pressure in interior volume 738. Internal volume (e.g., a sealed therapeutic environment) and/or target tissue 736 may be isolated from an external environment (associated with an ambient pressure). Reduced-pressure applied to interior volume 738 can induce macrostrain and microstrain in tissue site 720. In some implementations, reduced-pressure applied uniformly through the manifold 734 in interior volume 738 induces macrostrain and microstrain in target tissue 736.
[00110] As reduced-pressure is provided via pressure/fluid lumen (e.g., 120), pressure at dressing 716 may be communicated to first pressure sensor 772 and second pressure sensor 774 via first sense lumen (e.g., 124) and second sense lumen (e.g., 126), respectively. The pressure communicated by via first sense lumen (e.g., 124) and second sense lumen (e.g., 126) may be representative of the pressure at the target tissue 736. Each of first pressure sensor 772
and second pressure sensor 774 are configured to generate sensor data that is communicated to controller 760 (e.g., processor 790). The sensor data provided to controller 760 enables device 710 to track treatment provided to target tissue 736 via dressing 716. Based on the sensor data, controller 760 (e.g., processor 790) may initiate operation of one or more valves (e.g., 776) between an open position and a closed position. For example, processor 790 may be configured to adjust a particular valve in response to a comparison of the sensor data (indicating that a pressure within the interior volume (e.g., 738)) to a threshold (e.g., 798).
[00111] In some implementations, processor 790 is configured to control reduced-pressure source 778 (e.g., a reduced-pressure source device) and/or one or more valves 776 based at least in part on the sensor data. For example, processor 790 may be configured to deactivate reduced-pressure source 778 in response to a determination that the sensor data indicates that a pressure within the interior volume (e.g., 738) is less than a first threshold (e.g., a first threshold pressure value). In some implementations, processor 790 is configured to operate at least one valve (e.g., 776) towards the open position upon or after deactivation of reduced- pressure source 778. To illustrate, the at least one valve may include the valve coupled to reduced-pressure source 778, the valve coupled to first pressure sensor 772, and/or the valve coupled to second pressure sensor 774. As another example, processor 790 may be configured to activate reduced-pressure source 778 in response to a determination that the sensor data indicate that a pressure within the interior volume (e.g., 738) is greater than or equal to a second threshold (e.g., a second threshold pressure value). Activation of reduced-pressure source 778 may reduce pressure within the interior volume (e.g., 738). In some implementations, processor 790 is configured to operate at least one valve (e.g., 776) towards the closed position upon or after activation of reduced-pressure source 778. The first threshold and the second threshold may have the same value. Alternatively, the first threshold and the second threshold may have different values (e.g., the second threshold may be greater than the first threshold).
[00112] In some implementations, valve 776 coupled to first pressure sensor 772 may be operated independent of valve 776 coupled to second pressure sensor 774. For example, controller 760 may operate valve 776 coupled to first pressure sensor 772 based on sensor data received from first pressure sensor 772 and/or based on a first set of one or more thresholds (e.g., 798). Controller 760 may operate valve 776 coupled to second pressure sensor 774 based on sensor data received from second pressure sensor 774 and/or based on a second set of one or more thresholds (e.g., 798). The first set of one or more thresholds and the second set of one or more thresholds may include one or more of the same threshold value(s) and/or one or
more different threshold value(s). Additionally, or alternatively, in other implementations, controller 760 may operate one or more of the valves based on an average of sensor data of two or more sensors. For example, controller 760 may control one or more valves, such as the valve coupled to reduced-pressure source 778 based on an average of the sensor data (received from sensors 772, 774) and a third set of one or more thresholds. The third set of one or more thresholds may include one or more of the same threshold value(s) and/or one or more different threshold value(s) as the first set of one or more thresholds and/or the second set of one or more thresholds.
[00113] Reduced-pressure provided by reduced-pressure source 778 via reduced- pressure/fluid lumen (e.g., 120) can cause exudate, fluid, and/or another material to be drawn (e.g., removed) from target tissue 736 (e.g., tissue site 720) via tube 714 (e.g., reduced- pressure/fluid lumen) and second port/interface 782. Exudate, fluid, and/or another material removed via second port/interface 782 may be collected in fluid chamber 770 (e.g., a canister) for disposal. In some implementations, device 710 may include a sensor (not show) coupled to controller 760 (e.g. processor 790) and configured to monitor a volume of fluid chamber 770. For example, processor 790 may receive sensor data from the sensor that indicates a fill level of fluid chamber 770. In response to a determination by processor 790 that the fill level is greater than or equal to a threshold (e.g., a threshold fill level value), processor 790 is configured to deactivation of reduced-pressure source 778, operate at least one valve (e.g., 776) towards the open position, or both. Additionally, or alternatively, based on a determination by processor 790 that the fill level is greater than or equal to a threshold, processor 790 may initiate a notification (e.g., an alarm), such as a message via a display, an audio and/or visual notification, transmit a data message to another device, or a combination thereof.
[00114] If device 710 is coupled to dressing 716 such that reduced-pressure is not provided to cavity 750, deformation of deformable member 752 occurs to cause a reduction in a volume of cavity 750. When deformable member 752 is in a deformed state (e.g., a second state), deformable member 752 is configured to cause fluid communication via the primary channel and/or the primary lumen (e.g., 121) to be restricted and/or prohibited. Additionally, by deformable member 752 reducing/limiting the amount of reduced-pressure at the tissue site 720, excess reduced-pressure at tissue site 720 may be avoided.
[00115] Thus, FIG. 7 describes system 700 for providing reduced-pressure therapy. System 700 may advantageously include connector 730 (e.g., cavity 750 and deformable member 752) configured to restrict and/or prohibit a flow path to reduce or limit an amount of reduced-
pressure at the tissue site if reduced-pressure is provided to cavity 750. To illustrate, if reduced- pressure may be applied to cavity 750, deformable member 752 may constricts (e.g., forms) to cause blockage of one or more conduits/channels of connector 730, thereby avoiding or limiting excess reduced-pressure and/or fluid or exudate removal at tissue site 720. Blocking one or more conduits/channels of the connector 730 may deter and/or prevent intentionally or accidentally modification and/or bypassing of one or more components/features of system 700. Accordingly, cavity 750 and/or deformable member 752 may enable effective, efficient, and safe reduced-pressure therapy through use of system 700, thereby advancing patient reliability and confidence in the treatment.
[00116] FIG. 8 illustrates a method 800 of operating a connector (of a dressing). The method 800 may be performed at or by a connector, such as connector 130, connector 230, connector 630, or connector 730. In some implementations, the connector may be included in a reduced- pressure system (e.g., a reduced-pressure therapy system), such as system 100 (e.g., connector 130), a system that includes connector 230, a system that includes connector 630, or the system 700 (e.g., connector 730).
[00117] Method 800 includes receiving reduced-pressure at a cavity of a connector, at 810. The cavity may include or correspond to cavity 150, cavity 250, cavity 650, or cavity 750. The reduced-pressure may be received at the connector from a reduced power source via a tube.
[00118] Method 800 further includes, responsive to the reduced-pressure, deforming a deformable member positioned within the cavity, at 812. For example, the deformable member may include or correspond to deformable member 152, deformable member 252, deformable member 652, or deformable member 752.
[00119] Method 800 also includes blocking, based on the deformable member, at least a portion of an opening of a conduit of the connector, 814. The conduit may include conduit 272 or conduit 672. Additionally, or alternatively, the conduit may be at least partially blocked by a cover layer (e.g., 260, 660).
[00120] Thus, method 800 describes operation of a connector to restrict and/or prohibit a flow path to reduce or limit an amount of reduced-pressure at the tissue site if reduced-pressure is provided to the cavity. By causing a blockage of one or more conduits/channels of the connector, excess reduced-pressure and/or fluid or exudate removal at the tissue site may be limited and/or avoided. Additionally, blocking one or more conduits/channels of the connector may deter and/or prevent intentionally or accidentally modification and/or bypassing of one or more components/features of the reduced therapy system. Accordingly, the connector may
enable effective, efficient, and safe reduced-pressure therapy through use of the reduced- therapy system.
[00121] FIG. 9 illustrates a method 900 of operating a reduced-pressure system. The method 900 may be performed at or by system 100 (e.g., connector 130), a system that includes connector 230, a system that includes connector 630, or the system 700 (e.g., connector 730).
[00122] Method 900 includes coupling a dressing including a connector to a tissue site of a patient, at 910. For example, the dressing may include or correspond to dressing 116, a dressing that includes connector 230, a dressing that includes connector 630, or dressing 716. The tissue site may include or correspond to tissue site 120, tissue site 720, and/or target tissue 736. The connector may include or correspond to connector 130, connector 230, connector 630, or connector 730.
[00123] In some implementations, the connector includes a connector body configured to define at least a portion of a cavity in which a deformable member is positioned. For example, the connector body may include or correspond to body 142, body 242, body 642, or body 742. The cavity may include or correspond to cavity 150, cavity 250, cavity 650, or cavity 750. In some implementations, the cavity may be defined by the body, a cover layer (e.g., 260, 660), a spigot (e.g., 270, 670), an interface (e.g., 146, 246, 646, 746), or a combination thereof. The deformable member may include or correspond to deformable member 152, deformable member 252, deformable member 652, or deformable member 752.
[00124] Method 900 further includes coupling the dressing to a reduced-pressure source via one or more tubes, at 912. For example, the reduced-pressure source may include or correspond to reduced-pressure source 778. The one or more tubes may include or correspond to tube 114, tube 314, tube 414, tube 514, tube 614, and/or tube 714.
[00125] Method 900 also includes providing, by the reduced-pressure source, reduced- pressure to the dressing, at 914. If the dressing is coupled to the reduced-pressure source such that reduced-pressure is not provided to the cavity, deformable member maintains an undeformed state (e.g., the a state) in which fluid communication via a primary channel (of the connector) and/or a primary lumen (e.g., 121) of a tube is unobstructed/unrestricted. In such situations, exudate, fluid, and/or another material may be drawn (e.g., removed) from the tissue site via the primary lumen (e.g., the reduced-pressure/fluid lumen). Alternatively, if the device is coupled to a reduced-pressure source such that reduced-pressure is provided to the cavity, deformation of deformable member occurs to cause a reduction in a volume of cavity. When deformable member is in a deformed state (e.g., a second state), deformable member is
configured to cause fluid communication via the primary channel and/or the primary lumen to be restricted and/or prohibited. By reducing/limiting the amount of reduced-pressure at the tissue site, excess reduced-pressure at tissue site may be avoided.
[00126] Thus, method 900 describes operation of a reduced-pressure system (e.g., a reduced- pressure therapy system) to a tissue site. The system may advantageously be configured to restrict and/or prohibit a flow path to reduce or limit an amount of reduced-pressure at the tissue site if reduced-pressure is provided to the cavity of connector. By restricting and/or prohibiting the flow path, excess reduced-pressure and/or fluid or exudate removal at the tissue site may be limited and/or avoided in situations where one or more components/features of the reduced therapy system were intentionally or accidentally modified and/or bypassed. Accordingly, the system may be configured to ensure effective, efficient, and safe reduced-pressure therapy.
[00127] It is noted that one or more operations described with reference to one of the methods of FIGS. 8-9 may be combined with one or more operations of another of FIGS. 8-9. For example, one or more operations of method 800 may be combined with one or more operations of method 900.
[00128] The above specification and examples provide a complete description of the structure and use of illustrative examples. Although certain aspects have been described above with a certain degree of particularity, or with reference to one or more individual examples, those skilled in the art could make numerous alterations to aspects of the present disclosure without departing from the scope of the present disclosure. As such, the various illustrative examples of the methods and systems are not intended to be limited to the particular forms disclosed. Rather, they include all modifications and alternatives falling within the scope of the claims, and implementations other than the ones shown may include some or all of the features of the depicted examples. For example, elements may be omitted or combined as a unitary structure, connections may be substituted, or both. Further, where appropriate, aspects of any of the examples described above may be combined with aspects of any of the other examples described to form further examples having comparable or different properties and/or functions, and addressing the same or different problems. Similarly, it will be understood that the benefits and advantages described above may relate to one example or may relate to several examples. Accordingly, no single implementation described herein should be construed as limiting and implementations of the disclosure may be suitably combined without departing from the teachings of the disclosure.
[00129] The previous description of the disclosed implementations is provided to enable a
person skilled in the art to make or use the disclosed implementations. Various modifications to these implementations will be readily apparent to those skilled in the art, and the principles defined herein may be applied to other implementations without departing from the scope of the disclosure. Thus, the present disclosure is not intended to be limited to the implementations shown herein but is to be accorded the widest scope possible consistent with the principles and novel features as defined by the following claims. The claims are not intended to include, and should not be interpreted to include, means-plus- or step-plus-function limitations, unless such a limitation is explicitly recited in a given claim using the phrase(s)“means for” or“step for,” respectively.
Claims
1. A connector for a dressing of a reduced-pressure system, the connector comprising: a connector body configured to define at least a portion of a first cavity;
a conduit coupled to the connector body; and
a deformable member positioned within the first cavity and configured to be transitionable between a first state and a second state, wherein, when the deformable member is in a first state, the deformable member is configured to allow flow through the conduit, and when the deformable member is in the second state, the deformable member is configured to restrict flow through the conduit.
2. The connector of claim 1, wherein the deformable member is configured to transition from the first state to the second state responsive to reduced-pressure applied to the first cavity.
3. The connector of any of claims 1-2, wherein the deformable member is coupled to the connector body.
4. The connector of any of claims 1-3, wherein the deformable member comprises a porous structure.
5. The connector of any of claims 1-4, wherein the deformable member comprises an open cell foam.
6. The connector of any of claims 1-5, wherein the deformable member comprises a through hole configured to align with an opening of the conduit when the deformable member is in the first state.
7. The connector of any of claims 1-6, wherein the first cavity is configured to be open to an ambient atmospheric pressure when the deformable member is in the first state.
8. The connector of any of claims 1-7, wherein, when the deformable member is in the second state, the deformable member is configured to prevent flow through the conduit.
9. The connector of any of claims 1-8, wherein the first state comprises an undeformed state.
10. The connector of any of claims 1-9, wherein the second state comprises a deformed state.
11. The connector of any of claim 1-10, further comprising:
a cover layer, wherein the first cavity is further defined by the cover layer.
12. The connector of claim 10, wherein the cover layer is coupled to the connector body, the deformable member, or both.
13. The connector of any of claims 1-12, further comprising:
a port configured to be coupled to a tube comprising one or more lumens; and wherein the connector body is coupled to the port.
14. The connector of claim 13, wherein the port is configured to be coupled to a reduced- pressure source via the tube.
15. The connector of any of claims 13-14, wherein the port is integrally formed with the connector body.
16. The connector of any of claim 13-15, further comprising:
a spigot coupled to the connector body; and
wherein the spigot extends at least partially through the port and comprises at least a portion of the conduit.
17. The connector of any of claims 1-16, wherein the connector body is further configured to define at least a portion of a second cavity.
18. The connector of claim 17, wherein the conduit is configured to enable fluid communication between the second cavity and a first lumen of the one or more lumens.
19. The connector of any of claims 17-18, wherein:
the conduit comprises a first opening and a second opening; and
the deformable member is configured to block at least a portion of the first opening of the conduit to restrict the flow through the conduit.
20. The connector of claim 19, wherein the second opening of the conduit is configured to be positioned within the first lumen of the one or more lumens.
21. The connector of any of claims 17-20, wherein:
the second cavity includes a cavity aperture at a first end of the connector body;
the port extends from a second end of the connector body; and
the connector body configured to be coupled to a tissue site via the first end of the connector body and configured to be coupled to a reduced-pressure source via the second end of the connector body.
22. The connector of claim 21, further comprising:
a base extending form a peripheral portion of the connector body associated with the cavity aperture.
23. The connector of any of claims 17-22, wherein the port comprises one or more lumen interfaces.
24. The connector of claim 23, further comprising:
a channel extending between the second cavity and a lumen interface of the one or more lumen interfaces.
25. A dressing comprising:
the connector of any of claims 1-24; and
a drape coupled to the connector and configure to be coupled to a tissue site.
26. The dressing of claim 25, further comprising:
a tube configured to be coupled to the connector and comprising one or more lumens.
27. The dressing of claim 26, wherein:
the tube is coupled to the port of the connector; and
the tube comprises multiple lumens including a primary lumen, one or more ancillary lumens, one or more integrity lumens, or a combination thereof.
28. The dressing of any of claims 25-27, further comprising:
a manifold coupled to the connector, the drape, or both.
29. The dressing of claim 28, wherein the manifold comprises a foam.
30. A system comprising:
the dressing of any of claims 25-29; and
a reduced-pressure source configured to be coupled to the connector via one or more tubes.
31. A method comprising:
coupling a dressing of any of claims 25-29 to a tissue site of a patient;
coupling the dressing to a reduced-pressure source via one or more tubes; and providing, by the reduced-pressure source, reduced-pressure at the dressing.
32. The method of claim 31, further comprising:
responsive to reduced-pressure provided to the first cavity, deforming the deformable member.
33. A connector for a dressing of a reduced-pressure system, the connector comprising: a connector body configured to define at least a portion of a first cavity; and a deformable member configured to, responsive to reduced-pressure applied to the first cavity, deform to affect flow through the connector body.
34. The connector of claim 33, further comprising:
a conduit coupled to the connector body, and
wherein the deformable member is configure to, responsive to reduced-pressure applied to the first cavity, deform to affect flow via the conduit.
35. The connector of claim 33, wherein the deformable member is configured to deform to restrict the flow through the connector body.
36. The connector of claim 33, wherein the deformable member is configured to deform to prevent the flow through the connector body.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US201862739696P | 2018-10-01 | 2018-10-01 | |
US62/739,696 | 2018-10-01 |
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WO2020072493A1 true WO2020072493A1 (en) | 2020-04-09 |
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Application Number | Title | Priority Date | Filing Date |
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PCT/US2019/054067 WO2020072493A1 (en) | 2018-10-01 | 2019-10-01 | Apparatus, system, and method for a connector of a dressing of a reduced-pressure system |
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WO (1) | WO2020072493A1 (en) |
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WO2015123340A1 (en) * | 2014-02-11 | 2015-08-20 | Spiracur Inc. | Methods and devices for applying closed incision negative pressure wound therapy |
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US20120316538A1 (en) * | 2003-09-08 | 2012-12-13 | Jeremy Heiser | Osmotic Wound Vacuum System |
US20100228188A1 (en) * | 2007-10-30 | 2010-09-09 | Medela Holding Ag | Device for connecting a suction hose |
US20100137775A1 (en) * | 2008-11-25 | 2010-06-03 | Spiracur Inc. | Device for delivery of reduced pressure to body surfaces |
US20120184931A1 (en) * | 2011-01-14 | 2012-07-19 | Denny Horn | Suction line for a vacuum wound treatment device comprising connector parts |
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