HK1156891A - A system and method for delivering reduced pressure to subcutaneous tissue - Google Patents

Abstract

A reduced pressure treatment system (100) includes a first fluid pathway (112) in communication with a reduced pressure source and a second fluid pathway (142). The system includes a reduced pressure manifold (102) having a substantially gas impermeable barrier (320) and at least one outer conduit (250) defining a lateral edge of an interior region. The outer conduit and the substantially gas impermeable barrier enclose a portion of the interior region. The outer conduit is in fluid communication with one of the first and second fluid pathways. The outer conduit has at least one opening in fluid communication with the interior region. An inner conduit (230) is at least partially disposed within the interior region and is in fluid communication with another of the first and second fluid pathways. The inner conduit has at least one opening in fluid communication with the interior region.

Description

Systems and methods for delivering reduced pressure to subcutaneous tissue

Cross Reference to Related Applications

This application claims benefit of U.S. provisional application No. 61/098,164 filed on 18.9.2008, which is hereby incorporated by reference.

Background

Technical Field

The present invention relates generally to tissue treatment systems and, in particular, to systems for delivering reduced pressure to subcutaneous tissue.

Description of the Related Art

Clinical studies and practice have shown that providing reduced pressure in the vicinity of a tissue site increases and accelerates the growth of new tissue at the tissue site. Applications of this phenomenon are numerous, but one particular application of reduced pressure relates to the treatment of wounds. This treatment (often referred to in the medical community as "negative pressure wound therapy," "reduced pressure therapy," or "vacuum therapy") provides a number of benefits, including the transplantation of epithelial and subcutaneous tissue, improved blood flow, and micro-deformation of the tissue at the wound site. These benefits together lead to increased granulation tissue formation and faster healing times. Typically, reduced pressure is applied to tissue by a reduced pressure source through a porous pad or other manifold device. In many cases, wound exudate and other liquids from the tissue site are collected within the canister to prevent the liquids from reaching the reduced pressure source.

Brief description of the invention

The problems presented by current reduced-pressure systems and reduced-pressure dressings are addressed by the systems and methods of the illustrative embodiments described herein. In one illustrative embodiment, a reduced pressure treatment system includes a first fluid path and a second fluid path, the first fluid path in communication with a reduced pressure source. The system also includes a reduced-pressure manifold having a substantially gas-impermeable barrier (substentially gas impermeable barrier) and at least one outer conduit defining a lateral edge of the interior region. An outer conduit and a substantially gas impermeable barrier surround a portion of the interior region. The outer conduit is in fluid communication with one of the first and second fluid paths and has at least one opening in fluid communication with the interior region. An inner conduit is disposed at least partially within the interior region and is in fluid communication with the other of the first and second fluid paths. The inner conduit has at least one opening in fluid communication with the interior region.

In another illustrative embodiment, a reduced-pressure manifold for applying reduced-pressure treatment to a tissue site includes a substantially gas-impermeable barrier. An outer conduit is positioned on a first side of the barrier and defines a perimeter around the interior region and is adapted to be fluidly connected to one of a reduced pressure source and a vent source. The outer conduit has at least one opening in fluid communication with the interior region. An inner conduit is positioned on a first side of the barrier wall and extends into the interior region. The inner conduit is adapted to be fluidly connected to the other of the reduced pressure source and the vent source and has at least one opening in fluid communication with the interior region.

In another illustrative embodiment, a reduced pressure treatment system includes a reduced pressure source and a ventilation source. The system also includes a reduced-pressure manifold having a first conduit shaped to define an interior region. The first conduit is in fluid communication with one of a reduced pressure source and a vent source. The first conduit has at least one opening in fluid communication with the interior region. A second conduit is at least partially disposed within the interior region and is in fluid communication with the other of the reduced pressure source and the ventilation source. The second conduit has at least one opening in fluid communication with the interior region.

In yet another illustrative embodiment, a manifold for applying reduced pressure treatment to subcutaneous tissue is provided. The manifold includes a first conduit shaped to define an interior region and adapted to be fluidly connected to one of a reduced pressure source and a ventilation source. The first conduit has at least one opening in fluid communication with the interior region. A second conduit is disposed at least partially within the interior region and is adapted to be fluidly connected to the other of the reduced-pressure source and the ventilation source. The second conduit has at least one opening in fluid communication with the interior region.

In yet another illustrative embodiment, a method for delivering reduced pressure to a tissue site is provided. The method includes delivering fluid to the tissue site through a first conduit of annular shape, the first conduit defining a perimeter around the interior region. Reduced pressure is applied to the interior region through a second conduit positioned within the interior region, and tissue healing by-products (tissue healing by-products) are removed from the interior region through the second conduit.

In another illustrative embodiment, a method for delivering reduced pressure to a tissue site includes: reduced pressure is applied to the tissue site through a first conduit of annular shape, the first conduit defining a perimeter surrounding the interior area. The fluid is delivered to the interior region through a second conduit positioned within the interior region. Tissue healing byproducts are removed from the interior region through the first catheter.

Other features and advantages of the illustrative embodiments will become apparent with reference to the drawings and detailed description that follow.

Drawings

Figure 1 illustrates a perspective view of a reduced pressure treatment system having a reduced pressure manifold according to an illustrative embodiment;

figure 2 illustrates a schematic top view of the reduced-pressure treatment system of figure 1 with the barrier walls of the reduced-pressure manifold not shown for clarity purposes;

FIG. 3 illustrates a cross-sectional view of the reduced-pressure treatment system of FIG. 2 taken along line 3-3 positioned at a tissue site;

FIG. 4 illustrates a cross-sectional view of the reduced-pressure treatment system of FIG. 2 taken along line 4-4 positioned at a tissue site;

FIG. 5 illustrates a cross-sectional view of the reduced-pressure treatment system of FIG. 2 taken along line 5-5 positioned at a tissue site;

figure 6 illustrates a schematic top view of a reduced pressure treatment system for providing reduced pressure and fluid to a tissue site having a valve for reversing the flow of fluid and reduced pressure according to an illustrative embodiment;

FIG. 7 illustrates a cross-sectional view of the reduced-pressure treatment system of FIG. 6 taken along line 7-7 positioned at the tissue site;

figure 8 illustrates a schematic top view of a reduced pressure treatment system providing reduced pressure and fluid to a tissue site, according to an illustrative embodiment;

figure 9 illustrates a schematic top view of a reduced pressure treatment system providing reduced pressure and fluid to a tissue site, according to an illustrative embodiment; and

figure 10 illustrates a schematic top view of a reduced pressure treatment system providing reduced pressure and fluid to a tissue site according to an illustrative embodiment.

Detailed description of the preferred embodiments

In the following detailed description of some illustrative embodiments, reference is made to the accompanying drawings which form a part hereof, and in which is shown by way of illustration specific preferred embodiments in which the invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is to be understood that other embodiments may be utilized and that logical structural, mechanical, electrical, and chemical changes may be made without departing from the spirit or scope of the present invention. To avoid detail not necessary to enable those skilled in the art to practice the invention, the description may omit certain information known to those skilled in the art. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the illustrative embodiments is defined only by the appended claims.

Referring now primarily to fig. 1, an illustrative reduced pressure treatment system 100 includes a reduced pressure manifold 102 to apply reduced pressure to a tissue site 104. The reduced-pressure manifold 102 serves as a manifold for distributing reduced pressure. The term "manifold" as used herein generally refers to a substance or structure configured to assist in the application of reduced pressure to, the delivery of fluids to, or the removal of fluids from a tissue site. The manifold typically includes a plurality of flow channels or pathways to improve distribution of fluids provided to and removed from the tissue site. The reduced pressure manifold 102, which is a manifold, may include a number of layers, as will be described further below.

The tissue site 104 may be any human, animal, or other organic body tissue, including bone tissue, adipose tissue, muscle tissue, neural tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendons, ligaments, or any other tissue. Although the tissue site 104 may include wounds, diseased tissue, or defective tissue, the tissue site 104 may also be tissue without wounds, disease, or defects. Although the reduced-pressure manifold 102 may be used in any tissue site, including open wounds, the reduced-pressure manifold 102 is particularly effective when used on a subcutaneous tissue site, e.g., a subcutaneous tissue site such as the subcutaneous cavity and tissue site illustrated in fig. 1.

Applying reduced pressure to the tissue site 104 may be used to promote drainage of exudates and other fluids from the tissue site 104, as well as to stimulate growth of additional tissue. In the case where the tissue site 104 is a wound site, the growth of granulation tissue and the removal of secretions and bacteria promotes healing of the wound. The application of reduced pressure to non-wounded or non-defective tissue, including healthy tissue, may be used to promote the growth of tissue that may be excised and transplanted to another tissue site.

As used herein, "reduced pressure" generally refers to a pressure that is less than the ambient pressure at the tissue site being subjected to treatment. 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. The reduced pressure delivered may be constant or variable (patterned or arbitrary) and may be delivered continuously or intermittently. Although the terms "vacuum" and "negative pressure" may be used to describe the pressure applied to the tissue site, the actual pressure reduction applied to the tissue site may be significantly less than the pressure reduction normally associated with a complete vacuum. The reduced pressure may initially establish fluid flow within the area of the tissue site. As the hydrostatic pressure around the tissue site approaches the desired reduced pressure, the flow may drop and the reduced pressure is then maintained. Unless otherwise indicated, the values of pressure set forth herein are gauge pressures. Consistent with the use herein, an increase in reduced pressure or vacuum pressure generally refers to a relative decrease in absolute pressure, while a decrease in reduced pressure generally refers to an increase in absolute pressure.

Unless otherwise indicated, as used herein, "or" does not require mutual exclusivity.

Reduced pressure is provided to the reduced pressure manifold 102 by a reduced pressure delivery conduit 112. The reduced-pressure delivery conduit 112 receives reduced pressure from a reduced-pressure source 114. The reduced-pressure source 114 may be any device or subsystem for providing reduced pressure, including, but not limited to, a manually operated pump, an electric vacuum pump, a wall vacuum source, or any other device or system capable of providing reduced pressure. Although the amount and nature of the reduced pressure applied to the site will generally vary depending on the application, the reduced pressure is generally between about-5 mm Hg and about-500 mm Hg, and more typically between about-100 mm Hg and about-200 mm Hg. In one illustrative embodiment, the reduced pressure source 114 may be a battery-driven vacuum pump. In this example, the pump may use a low amount of power and be able to operate for an extended period of time based on a single charge of the battery.

One or more devices may be fluidly connected between the reduced-pressure manifold 102 and the reduced-pressure source 114. For example, a representative device 116 is shown fluidly connected to a portion of the reduced-pressure delivery conduit 112. Representative devices 116 may be fluid reservoirs or collection members to contain the exudate and other fluids that are removed. Other illustrative, non-limiting examples of devices 116 that may be included on the reduced pressure delivery conduit 112 or otherwise fluidly connected to the reduced pressure delivery conduit 112 include, but are not limited to, a pressure detection or feedback device, a volume detection system, a blood detection system, an infection detection system, a flow monitoring system, or a temperature monitoring system. Some of these devices may be integrally associated with the reduced-pressure source 114 or other aspects of the system.

The reduced-pressure manifold 102 is adapted to contact or cover a tissue site 104 to be treated. As used herein, the term "cover" includes partial or complete cover. In addition, the first object covering the second object may directly or indirectly contact the second object, or may not contact the second object at all.

The reduced-pressure manifold 102 is illustrated in fig. 1 as being positioned at a subcutaneous tissue site. The reduced-pressure manifold 102 may be placed at the tissue site surgically or percutaneously through the use of, for example, laparoscopic or endoscopic devices. When the reduced pressure manifold 102 is placed at a subcutaneous tissue site, the presence of tissue surrounding the cavity in which the reduced pressure manifold 102 is positioned results in a substantially sealed tissue site without the need for drapes or covers as required for open wound reduced pressure therapy. In the embodiment illustrated in fig. 1, the reduced-pressure delivery conduit 112 is percutaneously coupled to the reduced-pressure manifold 102.

The reduced-pressure delivery conduit 112 may be any tube, conduit, or flow path through which a gas, liquid, gel, or other fluid may flow. The following possible embodiments of the reduced pressure delivery conduit 112 are various and non-limiting examples. The reduced pressure delivery conduit 112 may have any cross-sectional shape, such as circular, elliptical, polygonal, or any other shape. Further, the reduced-pressure delivery conduit 112 may be made of any material and may be bendable or inflexible. In fig. 1, a reduced-pressure delivery conduit 112 fluidly connects the reduced-pressure manifold 102 to a representative device 116 and a reduced-pressure source 114. However, the reduced-pressure delivery conduit 112 may instead directly connect the reduced-pressure source 114 to the reduced-pressure manifold 102. Additionally, the reduced-pressure delivery conduit 112 may include one or more paths or lumens through which fluids may flow. For example, the reduced-pressure delivery conduit 112 may include two lumens, with one lumen for delivering reduced pressure and one lumen for monitoring the pressure to determine the amount of reduced pressure at the tissue site 104.

If the reduced pressure manifold 102 is used with an open wound or tissue site, a sealing member (not shown), such as a cover or drape, may be used to seal the reduced pressure manifold 102 at the tissue site. The sealing member may be any material that provides a fluid seal over the reduced-pressure manifold 102 and a portion of the patient's epidermis 118 or tissue surrounding the tissue site 104. For example, the sealing member may be an impermeable or semi-permeable elastomeric material. "elastomer" means having the properties of an elastomer. Generally, elastomers are polymeric materials having rubber-like properties. More specifically, most elastomers have an elongation greater than 100% and a significant amount of rebound. Rebound of a material refers to the ability of the material to recover from elastic deformation. Examples of elastomers that may be used in the sealing member include, but are not limited to: natural rubber, polyisoprene, styrene-butadiene rubber, chloroprene rubber, polybutadiene, nitrile rubber, isobutylene rubber, ethylene propylene diene monomer, chlorosulfonated polyethylene, vulcanized rubber, polyurethane, EVA film, copolyester, and silicone resin. In illustrative embodiments, the sealing member may be a drape, such as those used for surgical and other medical procedures.

If a sealing member is used to secure and seal the reduced-pressure manifold 102 at the open tissue site, the sealing member may be secured to the surrounding epidermis 118 or tissue using an adhesive, gasket, or other connection device. A connection member or other fitting may also be used for the sealing member to allow connection with the reduced-pressure delivery conduit 112 and to allow communication through the sealing member.

The reduced pressure treatment system 100 also includes a ventilation source 140 and a fluid delivery conduit 142 that fluidly connects the ventilation source 140 to the reduced pressure manifold 102. The control unit 160 may be operatively connected to either or both of the reduced pressure source 114 and the ventilation source 140 to control the delivery of reduced pressure and fluid to the reduced pressure manifold 102. A filter 170 may be fluidly connected between the ventilation source 140 and the reduced-pressure manifold to filter the fluid delivered through the fluid delivery conduit 142. More specifically, if the ventilation source 140 is vented to the atmosphere, the filter 170 may prevent particulates or microorganisms entering from the atmosphere from entering the reduced pressure manifold 102, as described below.

In one illustrative embodiment, the vent source 140 is a valve that allows the fluid transfer conduit 142 to vent to atmosphere. Because the tissue site 104 and the reduced-pressure manifold 102 are typically exposed to reduced pressure, venting the ventilation source 140 to the atmosphere causes a fluid (e.g., air) to flow through the ventilation ports 141 of the ventilation source 140 and into the fluid delivery conduit 142 toward the reduced-pressure manifold 102. The ventilation source 140 may be any form of valve, but in one illustrative embodiment, the ventilation source 140 is a valve that can be opened or closed by the control unit 160. In another embodiment, the ventilation source 140 may be a pump or any other device capable of delivering fluid to the reduced pressure manifold 102. Although the ventilation source 140 may be operated or controlled by electronic means, the ventilation source 140 may instead be operated by purely mechanical means. For example, the ventilation source 140 may be operated or controlled based on a pressure differential similar to a safety valve. Alternatively, the ventilation source 140 may be operated or controlled according to the rate of change of pressure. In one embodiment, the ventilation source 140 may also be manually operated or controlled by a user.

Similar to the reduced-pressure delivery conduit 112, the fluid delivery conduit 142 may be any tube, conduit, or flow path through which a gas, liquid, gel, or other fluid may flow. The reduced-pressure delivery conduit 142 may have any cross-sectional shape, such as circular, elliptical, polygonal, or any other shape. Further, the reduced-pressure delivery conduit 142 may be made of any material and may be bendable or inflexible. The fluid transfer conduit 142 may also include one or more lumens.

Referring still to fig. 1, but also to fig. 2-5, the reduced pressure manifold 102 is described in more detail. The reduced-pressure manifold 102 includes an inner conduit 230 and an outer conduit 250, which may have an annular shape configuration. In one embodiment, the outer conduit 250 may be physically arranged or formed to create a closed loop that defines the perimeter of the interior region 290. When the reduced-pressure manifold 102 is used to apply reduced-pressure treatment to the tissue site 104, the interior region 290 is positioned adjacent to the tissue site 104.

The proximal end 235 of the inner conduit 230 may extend outside of the interior region 290 to allow fluid communication with the reduced-pressure delivery conduit 112 or the fluid delivery conduit 142. The distal end 234 of the inner catheter 230 extends into the interior region 290. The distal end 234 may be open, but in one illustrative embodiment, the distal end 234 is a capped or closed end. The inner conduit 230 includes openings 236, 238, which may be holes, perforations, or individual slots through the inner conduit 230 within the interior region 290, for example. The outer conduit 250 includes a proximal end 255 to allow fluid communication with the fluid delivery conduit 142 or the reduced pressure delivery conduit 112. The outer conduit 250 includes openings 286, 288 through the outer conduit 250 adjacent the inner region 290.

In the embodiment illustrated in fig. 2-5, the inner conduit 230 is fluidly connected to the reduced pressure source 114 and the outer conduit 250 is fluidly connected to the ventilation source 140. The direction of fluid, either gas, liquid, or both, flowing through the conduits 230, 250 is generally indicated by fluid flow arrows. Fluid flow through the inner conduit 230 is indicated by arrow 239 and fluid flow through the outer conduit 250 is indicated by arrow 289. When reduced pressure is applied to the inner conduit 230 and fluid is provided to the outer conduit 250 by the ventilation source 140, fluid flows from the outer conduit 250 to the inner conduit 230 through the interior region 290. More specifically, as indicated by fluid flow arrows 286 ', 288', the fluid flows through the openings 286, 288 of the outer conduit 250. As indicated by fluid flow arrows 236 ', 238', fluid flows through the interior region 290 into the openings 236, 238 of the inner conduit 230.

Referring more specifically to fig. 3-5, the reduced-pressure manifold 102 includes a barrier 320 having a first side 322 and a second side 324. The inner conduit 230 and the outer conduit 250 are positioned on a first side 322 of the barrier 320. The presence of the barrier 320 may separate the interior region 290 from other regions of tissue proximate the reduced pressure manifold. In one embodiment, the interior region 290 is defined and surrounded by the outer catheter 250, the barrier 320, and the tissue site 104. For fluids flowing through the interior region 290 (i.e., fluids entering through the inner conduit 230 or the outer conduit 250 or fluids withdrawn from the tissue site 104), the barrier 320 functions to substantially restrict fluid flow to the area of the interior region 290 and the adjacent area surrounding the tissue site 104. The barrier 320 substantially reduces or prevents fluid flow onto the second side 324 of the barrier 320. In one embodiment, the barrier may be made of a substantially gas impermeable material. In another embodiment, the barrier 210 may be semi-permeable to gas flow. Examples of materials that may be used for the barrier 320 include, but are not limited to, silicone, polyurethane, or any other substantially gas impermeable material.

In operation, the reduced-pressure manifold 102 is positioned adjacent to or in contact with the tissue site 104. Reduced pressure is applied to the tissue site 104 and the interior region 290 by the reduced pressure source 114. Reduced pressure is delivered through the reduced pressure delivery conduit 112 and the inner conduit 230 of the reduced pressure manifold 102. Because of the relatively airtight nature of the subcutaneous tissue site, and the presence of the barrier 320, reduced pressure may be maintained at the tissue site 104 in order to provide reduced pressure treatment or therapy. When treatment begins, the growth of granulation tissue is stimulated. Wound exudate and other fluids are removed from the tissue site 104 and the interior region 290 through the inner conduit 230 and may be collected within a canister, such as represented by the representative device 116.

The growth of new tissue and the production of secretions and other byproducts at the tissue site 104 can impede treatment if not successfully removed. For example, if wound secretions or blood are collected within the conduit or at the tissue site 104, the delivery of reduced pressure to the tissue site 104 may be interrupted. The presence of the outer catheter 250 helps to minimize or prevent the collection of fluids, solids, or other byproducts at the tissue site and within the inner catheter 230. By conveying air or other fluids from the ventilation source 140 to the outer conduit 250 and the interior region 290, fluids, solids, and other byproducts may be better discharged and carried to the inner conduit 230. As illustrated in fig. 3, the fluid flow represented by arrows 286 ', 288' helps to carry the wound healing byproducts 340 to the inner conduit 230 where the byproducts 340 can be removed.

In one embodiment, it is desirable to apply reduced pressure, fluid flow (from the ventilation source 140), or both, to the reduced pressure manifold 102 intermittently. The regulation of the flow may be achieved by varying the upstream and downstream pressures, either manually or automatically by the control unit 160. This modulation and any resulting fluid momentum effects may also increase the fluid force applied to the byproducts 340.

The barrier 320 of the reduced pressure manifold 102 may also help to vent the byproducts 340. As previously described, the barrier 320 substantially restricts fluid flow to the area of the interior region 290 and adjacent areas surrounding the tissue site 104, which reduces the amount of fluid leaking outside of the interior region 290. This minimization of leakage optimizes flow from the outer conduit 250 to the inner conduit 230 within the interior region 290, as depicted by the fluid flow arrows illustrated in fig. 3.

Referring more specifically to fig. 5, in one embodiment, the opening 288 in the outer conduit 250 is one of several holes spaced along the length of the outer conduit 250 for conveying fluid from the ventilation source 140. The other openings may be evenly spaced along the length of the outer catheter 250 to evenly distribute fluid to the interior region 290 and the tissue site 210. Alternatively, the spacing between the openings may be varied or any distance. In one illustrative embodiment, the openings can have a diameter that generally increases in diameter as further removed from the source of fluid, such as, for example, openings 587 and 589, to evenly distribute the flow of fluid into interior region 290.

Referring to fig. 6, reduced pressure treatment system 600 is illustrated sharing some similar elements of reduced pressure treatment system 100. The reduced pressure treatment system 600 includes a reduced pressure manifold 102, a reduced pressure source 114, a representative device 116, a reduced pressure delivery conduit 112, a ventilation source 140, a filter 170, a fluid delivery conduit 142, and a control unit 160, all of which may be similar in structure and function to those elements previously described. Reduced pressure treatment system 600 may also include a switching unit or valve 695 fluidly connected between reduced pressure manifold 102 and both reduced pressure source 114 and vent source 140. The switching unit 695 is capable of reversing the flow of fluid within the inner conduit 230 and the outer conduit 250 relative to the flow direction previously described with respect to fig. 1-5. As illustrated in fig. 6, fluid flow within the outer conduit 250 may cause fluid to be removed toward the reduced-pressure source 114, as indicated by fluid flow arrows 689. Fluid from the inner region 290 flows into the openings 286, 288 of the outer conduit 250, as indicated by arrows 686 ', 688', respectively. Fluid flow within the inner conduit 230 may be provided by the ventilation source 140 and towards the interior region 290, as indicated by fluid flow arrows 639. Fluid enters the interior region 290 through the openings 236, 238 of the inner conduit 230, respectively, as indicated by arrows 636 ', 638'.

Figure 7 presents a cross-sectional view of reduced pressure treatment system 600 and demonstrates that removal of byproducts 340 may occur through outer conduit 250 when fluid is provided through inner conduit 230 by ventilation source 140. Although the flow of fluid is illustrated in fig. 6 and 7 as moving from inner conduit 230 to outer conduit 250, the presence of switching unit 695 allows the fluid flow to be reversed, which in some cases may help to drain or remove byproduct 340. In one embodiment, it may be desirable to reverse the flow of fluid through the reduced pressure manifold 102 regularly or intermittently.

Referring to figure 8, reduced pressure treatment system 800 includes some similar elements as those of reduced pressure treatment system 100. The reduced-pressure treatment system 800 includes a reduced-pressure manifold 802, the reduced-pressure manifold 802 being a modified version of the reduced-pressure manifold 102. The reduced-pressure manifold 802 includes an inner conduit 830 having a distal end in a closed-loop configuration. The distal end of the inner catheter 830 extends into the interior region 290, and the annular configuration of the inner catheter 830 defines a second interior region 890. The inner conduit 830 includes a proximal end 831, which proximal end 831 can be fluidly connected to either the reduced pressure source 114 or the ventilation source 140 by a switching unit 695. As described above, fluid flowing through the inner and outer conduits 830, 180 may be switched, causing fluid to flow in either direction within the interior region 290. The inner conduit 830 includes openings 832, 833, which may be holes, perforations, or a single slot, for example, through the inner conduit 830, adjacent to either or both of the inner region 290 and the second inner region 890. The openings 832 in the closed-loop conduit generally face the openings 286, 288 in the outer conduit 250, thereby creating a flow of fluid through the interior region 290, as previously described with respect to fig. 1-5. The openings 833 of the inner conduit 830 function in a similar manner to the openings 286, 288 of the outer conduit 250, but create a flow of fluid over a longer path deeper into the center of the second interior region 890.

Referring to figure 9, reduced pressure treatment system 900 includes some similar elements to those of reduced pressure treatment system 100. The reduced pressure treatment system 900 includes a reduced pressure manifold 902, the reduced pressure manifold 902 being a modified version of the reduced pressure manifold 102. Rather than only including a single inner conduit and a single outer conduit, the reduced-pressure manifold 902 illustrated in fig. 9 includes a first conduit 905, a second conduit 915, a third conduit 925, and a fourth conduit 935, the first conduit 905 defining a first interior region 910, the second conduit 915 positioned within the first interior region 910 and defining a second interior region 920, the third conduit 925 positioned within the second interior region 920 and defining a third interior region 930, the fourth conduit 935 positioned within the third interior region 930 and defining a fourth interior region 940. Each of the first conduit 905, the second conduit 915, the third conduit 925, and the fourth conduit 935 comprises a closed loop configuration. Each of the first, second, third and fourth conduits 905, 915, 925, 935 further includes apertures, slits or openings 950, 952, 954, 956, respectively, as previously described, allowing fluid communication with apertures within adjacent conduits and with interior regions 910, 920, 930, 940.

In the embodiment illustrated in fig. 9, both the first conduit 905 and the third conduit 925 are connected to one of the reduced pressure source 114 and the ventilation source 140, respectively. The second conduit 915 and the fourth conduit 935 are both connected to the other of the reduced pressure source 114 and the ventilation source 140, respectively. The unique configuration relating to which conduit is connected to which of the reduced pressure source and the vent source may vary. A switching unit similar to switching unit 695 may also be used to reverse fluid flow within one or more of the conduits.

The reduced pressure manifold 902 is configured as a plurality of nested tubes to provide increased fluid communication within the interior regions 910, 920, 930, 940. The reduced pressure manifold 902 doubles the number of conduits used in the reduced pressure manifold 802, and additional conduits may be added as desired. By increasing the number of conduits used with the reduced-pressure manifold 902, the manifold 902 is able to cover larger tissue sites or provide greater fluid control within smaller tissue sites.

Referring to fig. 10, the reduced pressure manifold 902 of fig. 9 is illustrated with one major modification. Instead of the conduits 905, 915, 925, 935 each being connected to a reduced pressure source 114 or a ventilation source 140, respectively, in the embodiment illustrated in fig. 10, some of the conduits are connected by a bridging conduit. For example, first conduit 905 is connected to third conduit 925 by a bridging conduit 965. This allows the reduced pressure or fluid delivered to the first conduit 905 to also be delivered to the third conduit 925. The second conduit 915 is connected to the fourth conduit 935 via a bridging conduit 970. This allows the reduced pressure or fluid delivered to the second conduit 915 to also be delivered to the fourth conduit 935.

As shown, the embodiments described above contemplate a reduced-pressure manifold for delivering reduced pressure to tissue, particularly subcutaneous tissue. In addition, these embodiments contemplate such reduced pressure manifolds using connecting conduits that serve to create a pressure gradient that moves fluid into the inner conduit and promotes the removal of tissue healing byproducts, such as blood and coagulum. Such a reduced pressure manifold, when fully attached to the barrier panel, further separates the reduced pressure on one side of the barrier panel. The application of controlled, varying pressure within the inner catheter and connecting catheter results in stronger pressure gradients and fluid forces that further facilitate the removal of tissue healing byproducts. An optional filter in the connecting conduit pathway may be advantageous to prevent infiltration of microorganisms into the tissue site.

Alternative or additional embodiments may include interwoven vents and pressure conduits, or surface features on the barrier wall that further direct flow to the inner conduit. A plurality of independent connecting conduits can be separately activated and controlled to redistribute fluid flow along the barrier wall panels. Medical fluids may also be introduced into the connecting conduit to promote tissue growth or treatment.

It is apparent from the foregoing that an invention having significant advantages has been provided. Although the invention is shown in only some of its forms, it is not just limited but is susceptible to various changes and modifications without departing from the spirit thereof.

Claims (79)

1. A reduced pressure treatment system comprising:

a first fluid path in communication with a reduced pressure source;

a second fluid path; and

a reduced-pressure manifold comprising:

a substantially gas impermeable barrier;

at least one outer conduit defining a lateral edge of an interior region, the outer conduit and the substantially gas impermeable barrier surrounding a portion of the interior region, the outer conduit in fluid communication with one of the first fluid path and the second fluid path, the outer conduit having at least one opening in fluid communication with the interior region; and

an inner conduit disposed at least partially within the interior region, the inner conduit in fluid communication with the other of the first and second fluid paths, the inner conduit having at least one opening in fluid communication with the interior region.

2. The reduced-pressure treatment system of claim 1, wherein the interior region includes an open end opposite the substantially gas-impermeable barrier positionable adjacent a tissue site.

3. The reduced-pressure treatment system of claim 2, wherein the substantially gas-impermeable barrier restricts fluid flow to the interior region when the interior region is positioned adjacent a tissue site.

4. The reduced-pressure treatment system of claim 1 wherein:

the outer conduit is fluidly connected to the second fluid path;

the inner conduit is fluidly connected to the first fluid path; and is

Fluid flows from the outer conduit to the inner conduit through the interior region.

5. The reduced-pressure treatment system of claim 4 further comprising: a surface feature on the substantially gas impermeable barrier that directs a flow of fluid to the at least one opening of the inner conduit.

6. The reduced-pressure treatment system of claim 1 wherein:

the inner conduit is fluidly connected to the second fluid path;

the outer conduit is fluidly connected to the first fluid path; and is

Fluid flows from the inner conduit to the outer conduit through the interior region.

7. The reduced pressure treatment system of claim 6, further comprising: a surface feature on the substantially gas impermeable barrier that directs flow of a fluid to the at least one opening of the outer conduit.

8. The reduced pressure treatment system of claim 1, further comprising: a controller to control introduction of fluid to the interior region through the second fluid path.

9. The reduced pressure treatment system of claim 1, further comprising: a controller to control removal of fluid from the interior region by the reduced pressure source.

10. The reduced pressure treatment system of claim 1, wherein the second fluid path is in fluid communication with a valve that selectively allows venting of the interior region to atmosphere.

11. The reduced-pressure treatment system of claim 1, wherein the second fluid path is in fluid communication with a pump configured to introduce fluid into the interior region.

12. The reduced-pressure treatment system of claim 1, wherein the inner conduit is substantially straight and includes a capped end.

13. The reduced-pressure treatment system of claim 1, wherein the at least one opening of the outer conduit includes a plurality of openings, each of the plurality of openings being disposed on a side of the outer conduit adjacent the interior region.

14. The reduced-pressure treatment system of claim 13, wherein each of the plurality of openings of the outer conduit is angled away from the substantially gas-impermeable barrier.

15. The reduced-pressure treatment system of claim 1 wherein the at least one opening of the inner conduit comprises a plurality of openings.

16. The reduced-pressure treatment system of claim 15, wherein each of the plurality of openings of the inner conduit is angled away from the substantially gas-impermeable barrier.

17. The reduced pressure treatment system of claim 1, further comprising: a switching unit fluidly connected to the inner and outer conduits to reverse fluid flow within the inner and outer conduits.

18. A reduced-pressure manifold for applying reduced-pressure treatment to a tissue site, the manifold comprising:

a substantially gas impermeable barrier;

an outer conduit disposed on a first side of the barrier and defining a perimeter around an interior region, the outer conduit adapted to be fluidly connected to one of a reduced pressure source and a ventilation source, the outer conduit having at least one opening in fluid communication with the interior region; and

an inner conduit positioned on a first side of the barrier and extending into the interior region, the inner conduit adapted to be fluidly connected to the other of the reduced-pressure source and the ventilation source, the inner conduit having at least one opening in fluid communication with the interior region.

19. The reduced-pressure manifold of claim 18, wherein fluid is adapted to flow from the outer conduit to the inner conduit through the interior region when the outer conduit is fluidly connected to the ventilation source and the inner conduit is fluidly connected to the reduced-pressure source.

20. The reduced-pressure manifold of claim 18, wherein fluid is adapted to flow from the inner conduit to the outer conduit through the interior region when the inner conduit is fluidly connected to the ventilation source and the outer conduit is fluidly connected to the reduced-pressure source.

21. The reduced-pressure manifold of claim 18, further comprising: surface features on the substantially gas impermeable barrier to direct the flow of fluid.

22. The reduced-pressure manifold of claim 18, wherein the inner conduit is substantially straight and includes a capped end.

23. The reduced-pressure manifold of claim 18, wherein the inner conduit is an annulus.

24. The reduced-pressure manifold according to claim 18, wherein the at least one opening of the outer conduit comprises a plurality of openings, each of the plurality of openings being disposed on a side of the outer conduit adjacent the interior region.

25. The reduced-pressure manifold of claim 24, wherein each of the plurality of openings of the outer conduit is angled away from the substantially gas-impermeable barrier.

26. The reduced-pressure manifold according to claim 18, wherein the at least one opening of the inner conduit comprises a plurality of openings.

27. The reduced-pressure manifold of claim 26, wherein each of the plurality of openings of the inner conduit is angled away from the substantially gas-impermeable barrier.

28. A reduced pressure treatment system comprising:

a reduced-pressure source;

a source of ventilation; and

a reduced-pressure manifold comprising:

a first conduit shaped to define an interior region and in fluid communication with one of the reduced-pressure source and the vent source, the first conduit having at least one opening in fluid communication with the interior region; and

a second conduit disposed at least partially within the interior region, the second conduit in fluid communication with the other of the reduced-pressure source and the ventilation source, the second conduit having at least one opening in fluid communication with the interior region.

29. The reduced-pressure treatment system of claim 28 wherein the reduced-pressure manifold further comprises:

a barrier; and is

Wherein the first conduit, the second conduit, and the interior region are positioned on a first side of the barrier.

30. The reduced-pressure treatment system of claim 29 further comprising: surface features on the barrier wall that direct the flow of fluid.

31. The reduced-pressure treatment system of claim 28 wherein:

the first conduit is fluidly connected to the ventilation source;

the second conduit is fluidly connected to the reduced pressure source; and is

Fluid flows from the first conduit to the second conduit through the interior region.

32. The reduced-pressure treatment system of claim 31 further comprising: a filter between the ventilation source and the at least one opening of the first conduit.

33. The reduced-pressure treatment system of claim 28 wherein:

the second conduit is fluidly connected to the ventilation source;

the first conduit is fluidly connected to the reduced pressure source; and is

Fluid flows from the second conduit to the first conduit through the interior region.

34. The reduced-pressure treatment system of claim 33 further comprising: a filter between the ventilation source and the at least one opening of the second conduit.

35. The reduced pressure treatment system of claim 28 further comprising: a controller to control introduction of fluid through the ventilation source to the interior region.

36. The reduced pressure treatment system of claim 28 further comprising: a controller to control removal of fluid from the interior region by the reduced pressure source.

37. The reduced pressure treatment system of claim 28 wherein the ventilation source is a valve that selectively allows ventilation of the interior region to atmosphere.

38. The reduced pressure treatment system of claim 28 wherein the ventilation source is a pump.

39. The reduced-pressure treatment system of claim 28 wherein the second conduit is substantially straight and includes a capped end.

40. The reduced-pressure treatment system of claim 28 wherein the at least one opening of the first conduit includes a plurality of openings, each of the plurality of openings being disposed adjacent the interior region.

41. The reduced-pressure treatment system of claim 28 wherein the at least one opening of the second conduit includes a plurality of openings.

42. The reduced pressure treatment system of claim 28 further comprising: a switching unit fluidly connected to the first and second conduits to reverse fluid flow within the first and second conduits.

43. The reduced-pressure treatment system of claim 28 wherein the second conduit is annular-shaped to define a second interior region, and the reduced-pressure manifold further comprises:

a third conduit positioned within the second interior region and annularly shaped to define a third interior region, the third conduit in fluid communication with one of the reduced-pressure source and the venting source, the third conduit having at least one opening in fluid communication with the third interior region; and

a fourth conduit positioned within the third interior region, the fourth conduit in fluid communication with one of the reduced-pressure source and the vent source, the fourth conduit having at least one opening in fluid communication with the third interior region.

44. The reduced-pressure treatment system of claim 28 wherein the second conduit is annular-shaped to define a second interior region, and the reduced-pressure manifold further comprises:

a third conduit positioned within the second interior region and annularly shaped to define a third interior region, the third conduit in fluid communication with one of the reduced-pressure source and the ventilation source in fluid communication with the first conduit, the third conduit having at least one opening in fluid communication with the third interior region; and

a fourth conduit positioned within the third interior region, the fourth conduit in fluid communication with the other of the reduced-pressure source and the ventilation source in fluid communication with the second conduit, the fourth conduit having at least one opening in fluid communication with the third interior region.

45. The reduced-pressure treatment system of claim 28 wherein the second conduit is annular-shaped to define a second interior region, and the reduced-pressure manifold further comprises:

a third conduit positioned within the second interior region and annularly shaped to define a third interior region, the third conduit in fluid communication with the first conduit, the third conduit having at least one opening in fluid communication with the third interior region; and

a fourth conduit positioned within the third interior region, the fourth conduit in fluid communication with the second conduit, the fourth conduit having at least one opening in fluid communication with the third interior region.

46. A manifold for applying reduced pressure treatment to a subcutaneous tissue site, the manifold comprising:

a first conduit shaped to define an interior region and adapted to be fluidly connected to one of a reduced pressure source and a vent source, the first conduit having at least one opening in fluid communication with the interior region; and

a second conduit disposed at least partially within the interior region, the second conduit adapted to be fluidly connected to the other of the reduced-pressure source and the ventilation source, the second conduit having at least one opening in fluid communication with the interior region.

47. The manifold of claim 46, further comprising:

a barrier; and is

Wherein the first conduit, the second conduit, and the interior region are positioned on a first side of the barrier.

48. The manifold of claim 47, further comprising: surface features on the barrier to direct the flow of fluid.

49. The manifold of claim 46, wherein fluid is adapted to flow from the first conduit to the second conduit through the interior region when the first conduit is fluidly connected to the ventilation source and the second conduit is fluidly connected to the reduced-pressure source.

50. The manifold of claim 46, where fluid is adapted to flow from the second conduit to the first conduit through the interior region when the second conduit is fluidly connected to the ventilation source and the first conduit is fluidly connected to the reduced-pressure source.

51. A manifold according to claim 46, wherein the second conduit is substantially straight and comprises a capped end.

52. A manifold according to claim 46, wherein the second conduit is an annulus.

53. The manifold of claim 46, where the at least one opening of the first conduit comprises a plurality of openings, each of the plurality of openings being disposed adjacent to the interior region.

54. The manifold of claim 46, further comprising:

a barrier; and is

Wherein the first conduit, the second conduit, and the interior region are positioned on a first side of the barrier;

wherein the at least one opening of the first conduit comprises a plurality of openings, each of the plurality of openings being disposed adjacent to the interior region; and is

Wherein each of the plurality of openings of the first conduit is angled away from the barrier.

55. The manifold of claim 46, where the at least one opening of the second conduit comprises a plurality of openings.

56. The manifold of claim 46, further comprising:

a barrier; and is

Wherein the first conduit, the second conduit, and the interior region are positioned on a first side of the barrier;

wherein the at least one opening of the second conduit comprises a plurality of openings; and is

Wherein each of the plurality of openings of the second conduit is angled away from the barrier.

57. The manifold of claim 46, wherein the second conduit is annular shaped to define a second interior region, and the reduced-pressure manifold further comprises:

a third conduit positioned within the second interior region and annularly shaped to define a third interior region, the third conduit adapted to be fluidly connected to one of the reduced-pressure source and the ventilation source, the third conduit having at least one opening in fluid communication with the third interior region; and

a fourth conduit positioned within the third interior region, the fourth conduit adapted to be fluidly connected to one of the reduced-pressure source and the ventilation source, the fourth conduit having at least one opening in fluid communication with the third interior region.

58. The manifold of claim 46, wherein the second conduit is annular shaped to define a second interior region, and the reduced-pressure manifold further comprises:

a third conduit positioned within the second interior region and annularly shaped to define a third interior region, the third conduit adapted to be fluidly connected to one of the reduced-pressure source and the ventilation source in fluid communication with the first conduit, the third conduit having at least one opening in fluid communication with the third interior region; and

a fourth conduit positioned within the third interior region, the fourth conduit adapted to be fluidly connected to the other of the reduced-pressure source and the ventilation source in fluid communication with the second conduit, the fourth conduit having at least one opening in fluid communication with the third interior region.

59. The manifold of claim 46, wherein the second conduit is annular shaped to define a second interior region, and the reduced-pressure manifold further comprises:

a third conduit positioned within the second interior region and annularly shaped to define a third interior region, the third conduit in fluid communication with the first conduit, the third conduit having at least one opening in fluid communication with the third interior region; and

a fourth conduit positioned within the third interior region, the fourth conduit in fluid communication with the second conduit, the fourth conduit having at least one opening in fluid communication with the third interior region.

60. A method of delivering reduced pressure to a tissue site, the method comprising:

delivering fluid to the tissue site through a first conduit of annular shape, the first conduit defining a perimeter around an interior region;

applying reduced pressure to the interior region through a second conduit positioned within the interior region; and

removing tissue healing byproducts from the interior region through the second catheter.

61. The method of claim 60, wherein the tissue site is a subcutaneous tissue site.

62. The method of claim 60, wherein the second conduit is annular in shape and defines a second interior region.

63. The method of claim 62, further comprising:

delivering fluid to the tissue site through a third conduit of annular shape positioned within the second interior region, the third conduit defining a perimeter around a third interior region;

applying reduced pressure to the third interior region through a fourth conduit positioned within the third interior region; and

removing tissue healing byproducts from the third interior region through the fourth catheter.

64. The method of claim 60, further comprising:

varying an amount of fluid delivered through the first conduit.

65. The method of claim 63, further comprising:

varying an amount of fluid delivered through the first conduit and the third conduit.

66. The method of claim 60, further comprising:

intermittently stopping the delivery of fluid through the first conduit.

67. The method of claim 63, further comprising:

intermittently stopping the delivery of fluid through the first conduit and the third conduit.

68. The method of claim 60, further comprising: filtering the fluid conveyed through the first conduit.

69. The method of claim 60, further comprising: switching the delivery of the fluid and the application of the reduced pressure such that the fluid is delivered through the second conduit and the reduced pressure is applied through the first conduit.

70. A method for delivering reduced pressure to a tissue site, the method comprising:

applying reduced pressure to the tissue site through an annularly shaped first conduit defining a perimeter around an interior area;

delivering a fluid to the interior region through a second conduit positioned within the interior region; and

removing tissue healing byproducts from the interior region through the first catheter.

71. The method of claim 70, wherein the tissue site is a subcutaneous tissue site.

72. The method of claim 70, wherein the second conduit is annular in shape and defines a second interior region.

73. The method of claim 72, further comprising:

applying reduced pressure to the tissue site through an annularly shaped third conduit positioned within the second interior region, the third conduit defining a perimeter around a third interior region;

delivering fluid to the third interior region through a fourth conduit positioned within the third interior region; and

removing tissue healing byproducts from the third interior region through the third catheter.

74. The method of claim 70, further comprising:

varying the amount of fluid delivered through the second conduit.

75. The method of claim 73, further comprising:

varying an amount of fluid delivered through the second conduit and the fourth conduit.

76. The method of claim 70, further comprising:

intermittently stopping the delivery of fluid through the second conduit.

77. The method of claim 73, further comprising:

intermittently stopping the delivery of fluid through the second and fourth conduits.

78. The method of claim 70, further comprising: filtering the fluid conveyed through the second conduit.

79. The method of claim 70, further comprising: switching the delivery of the fluid and the application of the reduced pressure such that the fluid is delivered through the first conduit and the reduced pressure is applied through the second conduit.