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WO2025043099A1 - Dispositifs à usages multiples et à usage unique pour interfaces d'injecteur - Google Patents

Dispositifs à usages multiples et à usage unique pour interfaces d'injecteur Download PDF

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Publication number
WO2025043099A1
WO2025043099A1 PCT/US2024/043457 US2024043457W WO2025043099A1 WO 2025043099 A1 WO2025043099 A1 WO 2025043099A1 US 2024043457 W US2024043457 W US 2024043457W WO 2025043099 A1 WO2025043099 A1 WO 2025043099A1
Authority
WO
WIPO (PCT)
Prior art keywords
use fitting
fitting
sensor
connector
extending
Prior art date
Application number
PCT/US2024/043457
Other languages
English (en)
Inventor
Christopher Capone
Michael Swantner
Ian MENEGO
Jaroslaw Wlodarczyk
Original Assignee
Bayer Healthcare Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bayer Healthcare Llc filed Critical Bayer Healthcare Llc
Publication of WO2025043099A1 publication Critical patent/WO2025043099A1/fr

Links

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
    • A61M39/10—Tube connectors; Tube couplings
    • 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
    • A61M2039/1044—Verifying the connection, e.g. audible feedback, tactile feedback, visual feedback, using external light sources
    • 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
    • A61M39/20—Closure caps or plugs for connectors or open ends of 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
    • 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

Definitions

  • connection fittings for use in injector systems or other means of dispersing medicine, such as contrast imaging agents.
  • a multi-use fitting comprising: a body defining a fluid flow path and at least a first portion of a slot; and at least one engaging surface extending from the body, the at least one engaging surface configured to displace a sensor.
  • Clause 22 The multi-use fitting of clause 21, wherein the at least one engaging surface comprises a flat surface extending from the body and a curved surface extending from the body along an end of the flat surface.
  • Clause 23 The multi-use fitting of clause 22, wherein the curved surface is configured to displace the sensor.
  • Clause 25 The multi-use fitting of any of clauses 21-24, further comprising at least one wing extending from the body, the at least one wing defining at least one retaining rib configured to secure the at least one wing to an interface.
  • Clause 26 The multi-use fitting of clause 25, wherein the at least one wing comprises a tapered leading edge, the tapered leading edge being configured to fit within the interface.
  • Clause 27 The multi-use fitting of clause 25 or 26, wherein the at least one wing comprises a finger press configured to flex the at least one wing to secure the at least one wing within the interface and to remove the at least one wing from the interface.
  • Clause 31 The multi-use fitting of clause 30, wherein the inlet is configured to be connected to a tubing, the tubing being configured to provide a medicament through the flow path.
  • Clause 32 The multi-use fitting of clause 30 or 31, wherein the outlet is configured to be connected to a single-use fitting.
  • Clause 33 The multi-use fitting of clause 32, wherein the single-use fitting is configured to provide the medicament to a patient.
  • Clause 34 The multi-use fitting of clause 33, wherein the body further defines a socket configured to engage a portion of the single-use fitting to connect the single-use fitting to the multi-use fitting.
  • Clause 35 The multi-use fitting of clause 30-34, wherein the body further defines an outer bore at least partially surrounding the inner bore, the outer bore defining the at least a first portion of the slot.
  • a single-use fitting comprising: a body defining an outlet at a first end; a connector extending from a second end of the body opposing the outlet, the connector defining an inlet, and a flange extending from the connector, wherein a fluid flow path is defined between the inlet and the outlet, and wherein the flange is configured to displace a sensor.
  • Clause 37 The single-use fitting of clause 36, wherein the flange defines an edge, and the edge comprises a vertical portion extending from the connector and a slanted portion extending from the vertical portion.
  • Clause 52 The dust cap of clause 51, wherein the slanted portion of the edge is configured to displace the sensor.
  • Clause 53 The dust cap of clause 51 or 52, wherein the front portion of the edge comprises a notch.
  • Clause 54 The dust cap of any of clauses 51-53, wherein the vertical portion of the edge extends from the connector to define an orthogonal angle therebetween, and the slanted portion of the edge extends from the vertical portion at an angle that is not orthogonal relative to the connector.
  • Clause 55 The dust cap of any of clauses 50-54, further comprising a locking lever configured to connect the dust cap to the multi-use fitting.
  • Clause 56 The dust cap of clause 55, wherein the locking lever comprises a tapered leading edge configured to be secured within a portion of the multi-use fitting.
  • Clause 58 The dust cap of any of clauses 50-57, wherein the connector is configured to mate with a bore of a multi-use fitting.
  • Clause 64 The connection system of any of clauses 60-63. wherein the at least one engaging surface comprises a first engaging surface and a second engaging surface, the first and second engaging surfaces defining at least a second portion of the slot therebetween.
  • connection system of clause 65 wherein the at least one wing comprises a tapered leading edge, the tapered leading edge being configured to fit within the interface.
  • connection system of clause 65 or 66 wherein the at least one wing comprises a finger press configured to flex the at least one wing to secure the at least one wing within the interface and to remove the at least one wing from the interface.
  • Clause 68 The connection system of any of clauses 65-67. wherein the at least one wing comprises a first wing and a second wing, and the at least one retaining rib comprises a first retaining rib disposed on the first wing and a second retaining rib disposed on the second wing.
  • Clause 69 The connection system of clause 68, wherein the first retaining rib and the second retaining rib correspond, respectively, to a first retaining lip and a second retaining lip on the interface to secure, respectively, the first wing and the second wing within the interface.
  • Clause 70 The connection system of any of clauses 60-69. wherein the flange defines an edge, and the edge comprises a vertical portion extending from the connector and a slanted portion extending from the vertical portion.
  • connection system of clause 70 or 71 wherein the vertical portion of the edge extends from the connector to define an orthogonal angle therebetween, and the slanted portion of the edge extends from the vertical portion at an angle that is not orthogonal relative to the connector.
  • connection system of any of clauses 70-72 further comprising a stop extending from the body, the stop being configured to at least partially impede the connection of the single-use fitting to the multi-use fitting.
  • Clause 74 The connection system of any of clauses 60-73, wherein the body of the multi-use fitting further defines a socket, and the single-use fitting comprises a locking lever configured to be received within the socket, further connecting the single-use fitting to the multi-use fitting.
  • connection system of any of clauses 60-74 wherein the bore defines an inlet and an outlet, the inlet of the bore being configured to be connected to a first tubing and the outlet of the bore being configured to mate with the connector of the single-use fitting, wherein the outlet of the single-use fitting is configured to be connected to a second tubing, thereby defining a system fluid flow path from the first tubing, through the fluid flow path of the multi-use fitting and the flow path of the single-use fitting, to the second tubing, and wherein the system fluid flow path is configured to receive a medicament and deliver the medicament to a patent downstream of the second tubing.
  • FIG. 1 is a perspective view of a connection system and assembly according to one embodiment of the present disclosure
  • Fig. 25 is a perspective view of the sensor assembly of the system of Fig. 20;
  • Fig. 26 is a front perspective view of a multi-use fitting of the system of Fig. 20;
  • Fig. 29 is a rear perspective view of a single-use fitting for the system of Fig. 20;
  • Fig. 31 is a cross-sectional view of the single-use fitting of the system of Fig. 20;
  • Fig. 32 is a perspective view of the multi-use fitting being connected to the interface of the system of Fig. 20;
  • Fig. 33 is a cross-sectional view of the multi-use fitting being connected to the interface of the system of Fig. 20;
  • Fig. 35 is a cross-sectional view of the multi-use fitting connected to and engaged with the sensor of the interface of the system of Fig. 20;
  • Fig. 36 is a perspective, cross-sectional view of the multi-use fitting connected to and engaged with the sensor of the interface of the system of Fig. 20;
  • Fig. 37 is a perspective view of the single-use fitting being connected to the multiuse fitting engaged within the interface of the sy stem of Fig. 20;
  • Fig. 38 is a perspective view of the single-use fitting connected to the multi-use fitting engaged within the interface of the system of Fig. 20;
  • Fig. 39 is a cross-sectional view of the single-use fitting being connected to the multi-use fitting engaged within the interface of the system of Fig. 20;
  • Fig. 41 is a cross-sectional view of the interface of the system of Fig. 20;
  • Fig. 42 is a perspective view of a dust cap that can be used with the multi-use fitting and the interface of the system of Fig. 20;
  • FIG. 43 is another perspective view of the dust cap of Fig. 42;
  • Fig. 44 is a cross-sectional view of the dust cap of Fig. 42;
  • Fig. 45 is a cross-sectional view 7 of the dust cap being engaged with the interface and the sensor of the system of Fig. 20;
  • Fig. 46 is a cross-sectional view of the dust cap connected to the interface and the sensor of the system of Fig. 20;
  • Fig. 47 is a perspective view of the dust cap and multi-use fitting being engaged with or removed from the interface and the sensor of the system of Fig. 20.
  • the fluid injector system has a powered injector administrator or device and a fluid delivery set intended to be associated with the injector to deliver one or more fluids from one or more multi-dose containers under pressure into a patient.
  • connection systems 10, 110 for use in injection systems for dispersing medicaments to patients. While connector systems 10 and 110 are exemplary embodiments, they should not be considered limiting and modifications and changes to connector systems 10 and 110 which do not impact the scope of features of the system should also be considered to be within the scope of the present disclosure. Both systems 10, 110 are designed to sense different connections between the different features. This sensing can help an administrator with the dispersal of the medicament and the replacement of the different parts of the system 10, 110. [00143] Embodiments of the present disclosure are directed to a connection system including an interface comprising a housing.
  • the interface 12 may also be mechanically and/or electrically connected to electronic systems that provide outputs to a controller or an administrator indicating different stages of assembly and use of the system 10.
  • the interface 12 holds the sensor 21 that senses the engagement of the multi-use fitting 14 and the single-use fitting 16 within the interface 12. How those fittings 14, 16 are connected to the interface 12 will be described herein.
  • the interface 12 includes a housing 22 that holds the sensor 21.
  • the sensor 21 may have a sensor arm 20 that includes a rib 24, a boss 25, a pivot arm 26, and a spring 28 or other biasing member extending around the pivot arm 26.
  • the pivot arm 26 is located a distance away from the rib 24 and is arranged so that the sensor arm 20 rotates about the pivot arm 26 within the housing 22 between at least the first position, the second position, and the third position. As shown in Figs. 3-5, the pivot arm 26 extends perpendicular to the part of the rib 24 extending along the edge of the sensor arm 20 and parallel to axis of the boss 25. On one end, the pivot arm 26 may have a cross-section having a cross shape, and on an opposing end, the pivot arm
  • the sensor arm 20 may be cylindrical. Other configurations and shapes may be appreciated, so long as the sensor arm 20 fits within the housing 22 and operates properly in the system 10 as described herein.
  • a spring 28 or other biasing element may fit around one end of the pivot arm 26, which is shown as the cross-shaped end in the figures. The spring 28 biases the pivot arm 26 in one direction within the housing 22, urging the sensor arm 20 to rotate in that direction. When fully biased by the spring 28, the sensor arm 20 can be considered to be in a first position. In other words, when the boss 25 and rib 24 are not contacted by the multi-use fitting 14 and/or the single-use fitting 16. the sensor 21 is in the first position.
  • These spaces 34, 36 are fluidly isolated from each other to prevent damage to one or both sides of the sensor 32 in the case fluid leaks into the housing 22.
  • this fluid isolation may protect the circuit board 32 from damage, as the fluid being injected by the injection system travels through the housing 22 in close proximity' to the sensor arm 21 and circuit board 32. Because the circuit board 32 detects the changes in the magnetic field created by the magnet 30, the circuit board 32 and the magnet 30 do not need to be visible to one another or otherwise have an unobstructed path between them.
  • Both spaces 34, 36 can take any shape so long as the sensor 21 is supported within the housing 22 and may freely move therein. In some embodiments, the sensor 21 may be located entirely within one space defined within the housing 22. To further protect the sensor 21.
  • a cap 38 may be applied to the top of the sensor 21, surrounding the top portions of the rib 24, boss 25, and pivot arm 26, and the entirety' of the spring 28.
  • the cap 38 can take any shape so long as it provides some protection to the sensor arm 20.
  • the cap 38 may also act as a rotational support for the pivot arm 26, allowing the pivot arm 26 to rotate within the housing 22.
  • a latch 40 may be disposed within the housing 22.
  • the latch 40 may include a body 42 that defines a ramp 44 and a latch lip 48. Latch 40 is configured to engage and releasably lock the multi-use fitting 14 wi thin interface 10. As shown in Fig.
  • the body 42 has a plate-like structure, with cylindrical ends that are affixed to corresponding ports within the housing 22.
  • a spring 46 (Fig. 16) may be disposed within the housing 22 and extend generally perpendicular to at least a portion of the plate-like surface of body 42 in order to bias the body 42 in one direction.
  • the body may also include a button 47.
  • the button 47 is used to release the latch 40 and acts against the spring 46 to disengage the multi-use fitting 14 from the interface 10.
  • the latch 40 may not include the button 47 to configure a releasing of the latch 40.
  • the latch 40 is disposed within another space 49 within the housing 22 that is separated from the other spaces 34, 36.
  • the housing 22 may include a clearance slot 23 that allows for tubing T that provides fluid communication between the one or more fluid reservoirs (not shown) the multi-use fitting 14, to also extend at least partially through the housing 22.
  • the clearance slot 23 will align with other features in the multi-use fitting 14 and the single-use fitting 16 to disperse medical fluids as described herein.
  • a multi-use fitting 14 according to certain embodiments is shown.
  • the multi-use fitting 14 has an inlet 52 in fluid communication with a valve 54 that also at least partially define the fluid flow path FP (shown in Fig. 10) with the passage(s) in the housing 22.
  • the valve 54 shown may be a swabable valve, which means that the valve 54 can be swabbed and cleaned with an alcohol pad or with other means prior to making any other connections.
  • the valve 54 may include at least one one-way valve or check valve allowing unidirectional fluid flow from the fluid reservoirs through the inlet 52 and exiting to the single-use tubing set through the at least one one-way valve when the single-use fitting 16 is engaged with the multi-use fitting 14.
  • valve 54 may have threads so that a mating piece, such as the single-use fitting 16, can be releasably screwed into place about the valve to create a fluid-tight connection between the valve 54 and that mating piece.
  • the valve 54 may include a polymeric plug (e.g., the swabable cover having a silicon cover with a resealable slit) that seals the flow path defined by the valve to prevent the ingress of pathogens from the surrounding environment.
  • a polymeric plug e.g., the swabable cover having a silicon cover with a resealable slit
  • Other valves and valve configurations known to those having skill in the art may also be used.
  • a body 56 extends around the valve 54 to define a receiving space 58 with the valve 54.
  • the body 56 may be arranged such that the inlet 52 extends in a proximal direction away from the body 56, and the valve 54 extends in a direction opposite that of the inlet 52 within the body 56.
  • the inlet 52 and the valve 54 may extend in different directions at different angles relative to each other, so long as the functionality of the multi-use fitting 14 remains intact.
  • the body 56 may be cylindrical or any other complimentary shapes and defines receiving slots 60 at opposing points along the circumference of the cylindrical shape for receiving the multi-use fitting 14 into the interface 12.
  • engaging surfaces 62 for engaging with a corresponding feature on the interface 12. which may be flat relative to the rest of the body 56, as shown.
  • the engaging surfaces 62 may be located on an outer surface of the body 56 opposing the inner surface that faces the valve 54. In other words, the engaging surfaces 62 may be considered to be on an outside surface of the body 56, while the valve 54 is located inside the body 56.
  • a mounting flange including a mounting face 64.
  • the mounting face 64 may substantially flat and extends in a rectangular shape about the valve 54. Although shown as having a rectangular shape, the mounting face 64 may also take other shapes, such as a, circular, square, diamond with tapered ends, etc.
  • the mounting face 64 may terminate with a mounting lip 66 extending about a least a portion of the perimeter of the mounting face 64.
  • the mounting lip 66 may substantially correspond in shape with the latch lip 48 to secure the multi-use connector 14 to the interface 12 as described herein.
  • the receiving slots 60 engaging surfaces.
  • the symmetrical nature of these features allows the multi-use fitting 14 to be oriented and applied to the housing 22 easily and in two or more different ways.
  • the symmetry of the multi-use fitting may allow the fitting to be installed without concern of the orientation (e.g., orientation- free) of the multi-use fitting 14 relative to the interface 12.
  • the shape of the mounting face 54 may be chosen with this symmetrical arrangement in mind, meaning that different shapes of the mounting face 54 may be used so long as those shapes provide for some symmetry about the body 56. The symmetry allows for a user to easily orient the multi-use fitting 14 relative to the housing 22.
  • the single-use fitting 16 may include a shroud 72, which is cylindrical in shape and extends about a connector 74.
  • the shroud 72 may serve to prevent inadvertent contact with the fluid connector 74, for example preventing touching of connector 74 while preparing the system for a fluid injection procedure.
  • the shroud 72 may engage and activate sensor 21 moving it to the third position when attached to the multi-use fitting 14 and interface 12.
  • the connector 74 is configured to fluidly and releasably connect to the valve 54 of the multi-use connector 14 and is an example of the mating piece discussed above.
  • the connector 74 and outlet 78 may also at least partially define the fluid flow path that is in line with the fluid flow paths in the multi-use fitting 14, multi-use tubing set, and housing 22.
  • Within the fluid flow path may be at least one check valve 77 that is provided to prevent reverse flow from the single-use tubing into the multi-use tubing and contamination of the multi-use set 14 with bodily fluids of the patient.
  • check valve 77 may include two check valves 77.
  • the multi-use fitting 14 slides into and releasably connects with the latch 40 in the housing 22 of the interface 12 as shown in Figs. 13-15.
  • the mounting face 64 of multi-use fitting 14 slides in the direction of the arrows as shown in Fig. 13 into receiving space 49 of interface 12 to engage latch 40.
  • the single-use fitting 16 is engaged using a corkscrew motion, having some rotational and some linear movement.
  • the linear movement of the single-use fitting 16 is shown by the arrows in Fig. 17.
  • the multi-use fitting 14 slides into the housing 22, such that one end of the mounting face 64 and its corresponding mounting lip 66 enter the space 49 within the housing 22 that holds the latch 40.
  • the mounting lip 66 is arranged along the end of the mounting face 64, such that part of the mounting lip 66 will slide up the ramp 44 of latch 40 and eventually engage with and lock into place against the latch lip 48 as the multi-use fitting 14 slides within the housing 22.
  • the engagement between the mounting lip 66 and the latch lip 48 may provide audible or tactile feedback to a user to signal a secure connection.
  • the engagement between the mounting lip 66 and the latch lip 48 may activate sensor 21, moving sensor arm 20 from the first position to the second position, causing the sensor 21 to send a signal to the controller that the multi-use fitting 14 is engaged with the interface 12.
  • the controller may then indicate to the user, for example by a pop-up window on a screed (GUI) associated with the fluid injector, change in lighting, or other audible or visual indication, that the multi-use fitting 14 is engaged. As this movement is occurring, the other elements of the multi-use fitting 14 are being received within the housing 22.
  • GUI pop-up window on a screed
  • the body 56 moves within the housing 22, so that the engaging surface 62 contacts the boss 25 of the sensor arm 20.
  • This contact moves the sensor arm 20 from the first position toward the second position.
  • the contact also occurs prior to the mounting lip 66 engaging with the latch lip 48.
  • the mounting lip 66 continues to move up the ramp 44, the engaging surface 62 pushes against the boss 25, rotating the sensor arm 20 about the pivot arm 26.
  • This action rotates the magnet 30, and the circuit board 32 senses that movement of magnet 30 to indicate movement from the first position tow ards and, ultimately, into the second position. This sensing can then be outputted to the controller to indicate some engagement between the multi-use fitting 14 and the interface 12 as indicated.
  • the sensor 21 can also sense when multi-use fitting 14 is only partially engaged with interface 12, which can also be outputted to the controller, which may then notify the user by a signal, for example by a pop-up window on a screed (GUI) associated with the fluid injector, change in lighting, or other audible or visual indication. This allows user of system 10 to know when multi-use fitting 14 is not fully engaged with interface 12.
  • GUI pop-up window on a screed
  • the single-use fitting 16 is moved to connect with the multi-use fitting 14 and the interface 12.
  • the single-use fitting 16 is aligned so that the connector 74 can mate with the valve 54, for example, by threadable connection.
  • the shroud 72 may also rotate as the connector 74 rotatably connected with the valve 54.
  • the shroud 72 may be shaped such that it extends through the space 58 and receiving slots 60 formed in the body 56 when the connector 74 is connected to the valve 54.
  • the extension of the shroud 72 into the receiving slots 60 and the placement of the receiving slots 60 next to the engaging surfaces 58 means that the end of the shroud 72 contacts the rib 24 of the sensor arm 20 of the sensor21, indicating that the single-use fitting 16 is being installed by moving the sensor arm 20 from the second position towards the third position.
  • the shroud 72 extends further into the receiving slots 60, where it contacts and pushes the rib 24 off of the engaging surface 62. This contact moves the sensor arm 20 from the second position to the third position. This rotates the sensor 21 further about the arm 26 compared to rotation caused the multi-use fitting 14 and results in additional sensing that the connection assembly is fully engaged and fluidly connected.
  • the sensor 21 has rotated an additional number of degrees against the biasing force of the spring 28 and has moved an additional distance within the housing 22 to the third position.
  • the rotation can be an additional 5-9° beyond the rotation already occurred by installation of the multi-use fitting 14.
  • the shroud 72 will have moved the sensor 21 arm, so that the sensor arm 21 is in the third position.
  • the sensor 21 can provide an output to the controller, for example by a pop-up window on a screed (GUI) associated with the fluid injector, change in lighting, or other audible or visual indication, indicating that the single-use fitting 16 is fluidly connected to the multi-use fitting 14 w ithin the interface 12.
  • GUI pop-up window on a screed
  • the sensor 21 may also provide an output, for example by a pop-up window on a screed (GUI) associated with the fluid injector, change in lighting, or other audible or visual indication, to indicate that the single-use fitting 16 is in the process of being connected to the multi-use fitting 16 before the connector 74 is fully mated with the valve 54 or if the single-use fitting 16 is incorrectly connected to the multi-use fitting 14.
  • GUI pop-up window on a screed
  • the controller may, in certain embodiments, initiate an auto-priming sequence to prime the tubing set and remove substantially all the air from the tubing set or, in other embodiments, indicate to the user that the system is ready for a priming operation.
  • the controller may signal the user that a setup fault has occurred, and the fluid injector system is not ready for priming and that the user must correct the fault before proceeding with the injection protocol.
  • each type of single-use fitting 16 may include a shroud 72 with a uniquely sized outer diameter. According to these embodiments, the differently sized shrouds 72 will push the rib 24 different amounts, and this will cause the rib 24 to rotate different amounts of degrees within the housing 22.
  • the circuit board 32 can detect these differences in rotation of the magnet 30 to identify the specific single-use fitting 16 in use.
  • withdrawing the fittings 14, 16 from the interface 12 can be done by, in one embodiment, simply pulling the multi-use fitting 14 from the housing 22 or, in another embodiment, pressing the button 47 to release the latch 44, which disengages the mounting lip 66 from the latch lip 48 and pulling the multi-use fitting 14 from the housing 22.
  • This allows the multi-use fitting 14 to be pulled out of the housing 22 in the opposite direction from which it entered.
  • the single-use fitting 16 may remain engaged with the multi-use fitting 14 during this disassembly, although this is not required, as throughout a series of injection procedures, the single-use fitting 16 of several single-use fittings 16 will be engaged and disengaged from the multi-use fitting 14.
  • the shroud 72 and the engaging surface 62 pull away from the rib 24. This allows the spring 28 to act on the sensor 21 and rotate the sensor 21 back in the direction of the first position within the housing 22.
  • the circuit board 32 also detects this rotation of the magnet 30. This allows for an output, telling an administrator that the multi-use fitting 14 and the single-use fitting 16 have been removed from the interface 12.
  • the single-use fitting 16 may also be removed on its own by disengaging the connector 74 with the valve 54. which is also detected by the sensor 21.
  • the shroud 72 is moved away from the rib 24, allowing the spring 28 to bias the rotating the rib 24 back into the second position from the third position.
  • This rotation is also detected by the circuit board 32 given its position relative to the magnet 30 and a signal is sent to the controller indicating that the system 10 is ready for attachment of the next single-use connector fitting 16.
  • the different sensor outputs allow an administrator to take an appropriate action to the interface 12 such as allowing or preventing the next step in the injection procedure. Such an action may be to replace the single-use fitting 16.
  • an action may be to replace the single-use fitting 16.
  • the injector system may be prevented from dispensing additional medicament until the sensor 21 senses that the used single-use fitting 16 has been removed and replaced with a new single-use fitting 16.
  • the injector may also have certain indicators, telling an administrator that the fluid inj ector is prepared to perform an inj ection procedure when a singleuse fitting 16 is detected as being connected to the multi-use fitting 14 with an injection having yet to be made with that single-use fitting 16.
  • the injection system may also have control over the dispersal of the medicament such that dispersal is prevented when the single-use fitting 16 and/or multi-use fitting 14 are not detected within the interface 12.
  • connection system 110 includes an interface 112, a multi-use fitting 114. and a single-use fitting 116 that are used in a similar manner to the system lO previously described.
  • the multi-use fitting 114 can be used for multiple injection procedures before being replaced, whereas the single-use fitting 116 is intended to be used once and is replaced within the system 110 after a single injection procedure.
  • a dust cap 216 may also be used in this system 110 and in various embodiments of system 10, which will be described herein.
  • the dust cap 216 can also be used multiple times, for example, the dust cap 216 may be attached to the multi-use fitting 114 between injection procedures to limit contact between atmospheric contaminants and the inner bore 142 of the multi-use fitting 114.
  • the interface 112 holds a sensor 127 that can detect when the multi-use fitting 114, single-use fitting 116, and dust cap 216 are properly connected to each other and interface 112. [00158] With reference to Figs. 20-25, the interface 1 12 and its various associated features are shown.
  • the interface 112 includes a housing 120 shaped to receive one or more of the multi-use fitting 114, the single-use fitting 116, the sensor 127, and the dust cap 216.
  • the housing 120 includes a first portion 120A and a second portion 120A that, as shown in Fig. 24, are separate parts connected with fasteners F via apertures A (only some labeled for clarity).
  • the housing 120 may be made of a single part capable of defining the receiving spaces discussed below and holding the relevant parts of the multi-use fitting 114, single-use fitting 115, sensor 127, and dust cap 216, which are also discussed below. With reference to Fig. 21.
  • the housing 120 defines a first receiving space 121 for holding at least a portion of the multi-use fitting 1 14 and at least a portion of the single-use fitting 116.
  • the first portion 120A of the housing 120 defines the majority of the first receiving space 121.
  • the first receiving space 121 may be understood to be a front receiving space given its arrangement at the front of the interface 112.
  • the first receiving space 121 is delineated with a backwall 122.
  • the backwall 122 includes a first portion 122 A that is defined by the first portion 120A of the housing 120 and a second portion 122B that is defined by a second portion 120B of the housing 120.
  • the first portion of the backwall 122A defines an opening 123 through which at least a part of the sensor 127 extends and is exposed within the first receiving space 121.
  • the backwall 122 and the first portion of the housing 120A both partially define a first depression 124 and a second depression 125 at opposing ends of the receiving space 121.
  • the first depression 124 and the second depression 125 are arranged to, respectively, receive or partially surround parts of the single-use fitting 116 and the multi-use fitting 114.
  • the first depression 124 and the second depression 125 may also be arranged to receive parts that are connected to single-use fitting 116 and multi-use fitting 114, such as tubing T or other features arranged to deliver medical fluid through connection system 110.
  • the housing 120 also defines a second receiving space 126 shaped to hold the sensor 127.
  • the second receiving space 126 is defined within the second portion of the housing 120B.
  • the second receiving space 126 is located on a side of the first portion of the housing 120A opposing the first receiving space 121.
  • the first portion of the housing 120A may also partially define the second receiving space 126. Because of this, the second receiving space 126 may be understood to be a first rear receiving space.
  • an embodiment of the sensor 127 includes a lever 128, a pivot arm 130, and a biasing member, such as spring 132.
  • An end of the lever 128 extends into the front receiving space 121 via the opening 123 in backwall 122.
  • the lever 128 is arranged to at least partially engage with portions of one or more of the multi-use fitting 114, the single use fitting 1 16, and the dust cap 216 via the opening 123.
  • This engagement rotates the lever 128 about the pivot arm 130 between at least a first position, a second position, a third position, and a fourth position, and the sensor 127 is configured to detect this rotation to determine various engagements between the interface 112, the multi-use fitting 114, the singleuse fitting 116, and/or the dust cap 216, which will be discussed herein.
  • the spring 132 may be wrapped around a portion of the lever 128 to bias the lever 128 against the direction of engagement so that in the absence of an engaging force, the lever 128 is biased to the first position.
  • the movement of the lever 128 between the different positions signifies engagement, or lack of engagement, with one or more of the multi-use fitting 114. single-use fitting 116. and/or the dust cap 216.
  • the lever 128 In the first position, the lever 128 is not engaged by any other element and is fully biased by the spring 132, so that it fully protrudes through the opening 123 and into the first space 121.
  • the housing 120 further defines a third receiving space 134 shaped to hold additional parts of the sensor 127, such as a circuit board or other electronics 136 (referred to herein as only the “circuit board 136”).
  • the third receiving space 134 is located on a side of the housing 120 opposing the first side receiving space 121. Because of this, the third receiving space 134 may be understood to be a second rear receiving space. In other words, when the first portion of the housing 120 A, and the second portion of the housing 120B are connected via fasteners F, the third receiving space 134 is on the side that opposes the first receiving space 121.
  • the third receiving space 134 may be a space defined within the second portion of the housing 122B, similar to the second receiving space 126, or the third receiving space 134 may be defined by alignment parts 135 as shown in Fig. 23. Alignment parts 135 are shaped to hold parts of the circuit board 136 therein, so that fasteners F can be used to secure the circuit board 136 to the second portion of the housing 120B. This is shown in Figs. 23 and 24. As shown in Fig. 23. third receiving space 134 may also be considered a receiving area. [00161] The third receiving space 134 is fluidically sealed from the first receiving space 121 and the second receiving space 126.
  • Various sidewalls, sealants, or other features in the rear side of the interface 112 can be used to fluidly seal the third receiving space 134.
  • the second portion of the housing 120B maintains the fluid separation between the third receiving space 134/circuit board 136 and the second receiving space 126/sensor 127.
  • the circuit board 136 is arranged to interact with a magnetic field of magnet 138 that is disposed within the pivot arm 130.
  • the magnet 138 is disposed in an end of the pivot arm 130, but in other embodiments, the magnet 138 may be arranged elsewhere within the sensor 127, so long as it can interact with the circuit board 136 in such a way to indicate the various positions (e g., first, second, third, and fourth positions).
  • the circuit board 136 is disposed a distance away from the magnet 138, for example, in vicinity to detect changes in the magnetic field produced by the magnet 138, and it is arranged to sense the rotation or other movement of the magnet 138 via the changes in the magnetic field created by the magnet 138.
  • the rotation of the pivot arm 130 created by rotation of the lever 128 also rotates the magnet 138 between at least the first, second, third, and fourth positions.
  • This rotation changes the magnetic field of the magnet 138, which interacts with the circuit board 136, for example via the hall effect, is sensed by the circuit board and signals are sent to a controller indicated the extent of the rotational change in the magnetic field of magnet 138, corresponding to positional movement of the system 110 between at least the first position, the second position, the third position, and the fourth position.
  • the magnet 138 creates a magnetic field
  • the circuit board 136 includes electronics that can sense the change in that magnetic field that occurs during rotation of the magnet 138 that is caused by rotation of the lever 128. This sensing can then be outputted to an administrator via the controller of the injection system to know the status of the system 110. Because the circuit board 136 detects the changes in the magnetic field created by the magnet 138, the circuit board 136 and magnet 138 do not need to be visible to one another or otherwise have an unobstructed path between them.
  • Figs. 26-28 show the multi-use fitting 114 according to various embodiments.
  • the multi-use fitting 114 includes a body 140, and the body 140 defines an inner bore 142 and an outer bore 143 surrounding the inner bore 132. At least a portion of the outer bore 143 defines opposing outer edges 147 that at least partially define a slot 146 between those edges 148. Opposing flat surfaces of outer edgesl48 extends from the body 140 and also at least partially define the slot 146. Opposing curved surfaces 149 extend, respectively, from the opposing flat surfaces 148 to further define the slot 146. The curved surfaces 149 are arranged to contact the lever 128 of sensor 127 when the multi-use fitting 114 is being secured within the first space 121 of the interface 112.
  • the curved surfaces 149 cause the lever 128 to be moved from the first position towards the second position as the multi-use fitting 114 is engaged with the interface 112.
  • the second position signifies the connection between the multi-use fitting 114 and the interface 112 has been correctly achieved.
  • the lever 128 moves between the first position and the second position, and the sensor can detect the partial engagement of the multi-use fitting 114 with the interface 112 by partial movement of the lever 128 towards the second position.
  • the flat surfaces 148 are arranged relative to the curved surfaces 149 to ensure that the multi-use fitting 114 fits easily within the housing 120 of the interface 112.
  • the flat surfaces 148 ensure that the multi-use fitting 1 14 is properly aligned within the first receiving space 121, so that the curved surfaces engage with the lever 128.
  • the alignment also ensures that retaining ribs 153, located on wings 150, which are both discussed below, are properly received within the first receiving space 151 and aligned with retaining lips 154, which are also discussed below.
  • the extension of the flat surfaces 148 from the body 140 and into the receiving space 121 also prevents rotation of the multi-use fitting 114 relative to the interface 112. In other words, the flat surfaces 148 extend into the receiving space 121, so that they are held within parts of the backwall 122 that prevent rotation of the multi-use fitting 114.
  • a stop 181 extends downward from the body 160 proximate the bottom opening 170.
  • the stop 181 extends away from the body 160 beyond the flange 174 and is arranged to act against the interface 112 when the single-use fitting 116 is engaged in the sy stem 110, so that the single-use fitting 116 only extends a certain distance into the multi-use fitting 114 and interface 112 during engagement and use.
  • a portion of the flange 174 may be connected to the stop 181.
  • the locking lever 182 may operate similarly to the wings 150, having a retaining rib that engages with a corresponding retaining lip within the socket 156. Other methods of securing the locking lever 182 within the socket 156 may also be used.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un système de connexion pouvant inclure une interface ayant un boîtier et un capteur disposé à l'intérieur du boîtier et configuré pour être déplacé entre une première position, une deuxième position et une troisième position ; un raccord à usages multiples ayant au moins une surface de mise en prise et une fente et étant configuré pour être fixé à l'intérieur du boîtier de sorte que l'au moins une surface de mise en prise déplace le capteur entre la première position et la deuxième position ; et un raccord à usage unique ayant une bride et étant configuré pour être fixé à l'intérieur du raccord à usages multiples de sorte que la bride est reçue à l'intérieur de la fente et s'y étend et déplace le capteur entre la deuxième position et la troisième position. Le capteur peut être configuré pour détecter un déplacement entre les première, deuxième et troisième positions, ce qui permet de détecter la mise en prise entre le raccord à usages multiples et l'interface et la mise en prise entre le raccord à usage unique et le raccord à usages multiples.
PCT/US2024/043457 2023-08-23 2024-08-22 Dispositifs à usages multiples et à usage unique pour interfaces d'injecteur WO2025043099A1 (fr)

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US202363578287P 2023-08-23 2023-08-23
US63/578,287 2023-08-23

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Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5383858A (en) 1992-08-17 1995-01-24 Medrad, Inc. Front-loading medical injector and syringe for use therewith
US7553294B2 (en) 2002-05-30 2009-06-30 Medrad, Inc. Syringe plunger sensing mechanism for a medical injector
US7666169B2 (en) 2003-11-25 2010-02-23 Medrad, Inc. Syringe and syringe plungers for use with medical injectors
US20140027009A1 (en) 2009-07-24 2014-01-30 Medrad, Inc. Multi-fluid medical injector system and methods of operation
EP3103490A1 (fr) * 2015-06-11 2016-12-14 Steadymed Ltd. Ensemble de perfusion
US20170203860A1 (en) * 2016-01-19 2017-07-20 Dr. Py Institute Llc Devices and methods for formulation processing
US10022493B2 (en) 2011-05-12 2018-07-17 Bayer Healthcare Llc Fluid injection system having various systems for controlling an injection procedure
US10507319B2 (en) 2015-01-09 2019-12-17 Bayer Healthcare Llc Multiple fluid delivery system with multi-use disposable set and features thereof
WO2020142185A1 (fr) * 2019-01-04 2020-07-09 Hollister Incorporated Connecteurs de tubes intelligents pour systèmes d'irrigation de cavité corporelle et connecteurs de tubes coaxiaux
US20220186867A1 (en) * 2019-05-14 2022-06-16 Oetiker Ny, Inc. Connection verifier
US20220285893A1 (en) * 2021-03-03 2022-09-08 Bellco S.R.L. Fluid connector

Patent Citations (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5383858B1 (en) 1992-08-17 1996-10-29 Medrad Inc Front-loading medical injector and syringe for use therewith
US5383858A (en) 1992-08-17 1995-01-24 Medrad, Inc. Front-loading medical injector and syringe for use therewith
US7553294B2 (en) 2002-05-30 2009-06-30 Medrad, Inc. Syringe plunger sensing mechanism for a medical injector
US7666169B2 (en) 2003-11-25 2010-02-23 Medrad, Inc. Syringe and syringe plungers for use with medical injectors
US20140027009A1 (en) 2009-07-24 2014-01-30 Medrad, Inc. Multi-fluid medical injector system and methods of operation
US8945051B2 (en) 2009-07-24 2015-02-03 Bayer Medical Care Inc. Multi-fluid medical injector system and methods of operation
US10022493B2 (en) 2011-05-12 2018-07-17 Bayer Healthcare Llc Fluid injection system having various systems for controlling an injection procedure
US10507319B2 (en) 2015-01-09 2019-12-17 Bayer Healthcare Llc Multiple fluid delivery system with multi-use disposable set and features thereof
EP3103490A1 (fr) * 2015-06-11 2016-12-14 Steadymed Ltd. Ensemble de perfusion
US20170203860A1 (en) * 2016-01-19 2017-07-20 Dr. Py Institute Llc Devices and methods for formulation processing
WO2020142185A1 (fr) * 2019-01-04 2020-07-09 Hollister Incorporated Connecteurs de tubes intelligents pour systèmes d'irrigation de cavité corporelle et connecteurs de tubes coaxiaux
US20220186867A1 (en) * 2019-05-14 2022-06-16 Oetiker Ny, Inc. Connection verifier
US20220285893A1 (en) * 2021-03-03 2022-09-08 Bellco S.R.L. Fluid connector

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