Implantable infusion device

• US 5,180,365 A
• Filed: 02/15/1991
• Issued: 01/19/1993
• Est. Priority Date: 03/01/1990
• Status: Expired due to Fees

• Current Assignee: James A. Knol, James C. Andrews, William D. Ensminger
• Original Assignee: James A. Knol, James C. Andrews, William D. Ensminger
• Inventors: Ensminger, William D., Knol, James A., Andrews, James C.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US07/654,661
• Time in Patent Office: 704 Days
• Field of Search: 604/167, 604/175, 604/93, 604/244, 604/283, 604/256, 604/280
• US Class Current: 604/288.03
• CPC Class Codes: A61M 2039/0211 with multiple chambers in a single site
• CPC Class Codes: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 2039/0633 the seal being a passive seal made of a resilient material with or without an opening
• CPC Class Codes: A61M 2039/064 Slit-valve
• CPC Class Codes: A61M 2039/0653 Perforated disc
• CPC Class Codes: A61M 2039/0666 Flap-valve
• CPC Class Codes: A61M 2039/0686 comprising more than one seal
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 39/0606 without means for adjusting the seal opening or pressure A61M39/0693 takes precedence

Abstract

An infusion port designed for the introduction of a catheter for fluid infusion or removal or other flexible filaments within a patient. The infusion port is buried subcutaneously and accessed using a needle which introduces the filament. The infusion port has means to prevent the introducing needle from being inserted past a certain point within the port whereas the introduced flexible element can be inserted beyond that point and is caused to be forced through an articulating valve. The valve of this disclosure features enhancements in its sealing ability and in some embodiments provides a differing level of frictional engagement with the filament upon insertion versus withdrawal. The infusion port of this invention also has design features which provide a relatively small distance between the surface of the skin and the position of the articulating catheter valve through which the introduced filament passes.

Claims

1. An implantable infusion port for allowing the introduction of a flexible filament such as a catheter wire or optical fiber into a patient and being accessed using a needle which penetrates the patient'"'"'s skin with said filament being introduced into the port by said needle, comprising:

housing means defining an enlarged generally funnel shaped entrance orifice, with the surface of said entrance orifice formed of a hard material to guide said needle contacting said orifice to a focus area,

mounting means for fastening said port subcutaneously, an entrance passageway formed by said housing means extending from said focus area to a valve chamber and to an exit passageway communicating with a site within the patient,

valve means within said valve chamber for permitting said filament to pass through said valve means while restricting the flow of fluids across said valve means when said filament is removed, and

stop means within said entrance passageway between said focus area and said valve chamber for restricting the passage of said needle while permitting said flexible filament to pass through said entrance passageway and engage said valve means.

2. An implantable infusion port according to claim 1 wherein said stop means comprises a bend in said entrance passageway.

3. An implantable infusion port according to claim 1 wherein said entrance orifice defines a surface having a first included cone angle adjacent the outside perimeter of said entrance orifice and defining a second included cone angle adjacent said focus area which is smaller than said first included cone angle.

4. An implantable infusion port according to claim 3 wherein said first and second included cone angles are formed by joined conical surfaces.

5. An implantable infusion port according to claim 1 wherein said housing means entrance orifice has a central axis generally perpendicular to the patient'"'"'s skin and further defines a projection which can be detected by external palpation after said port is implanted which indicates the orientation of said port.

6. An implantable infusion port according to claim 1 wherein said valve means comprises an articulating catheter valve.

7. An implantable infusion port according to claim 6 wherein said articulating catheter valve includes at least two leaflet valve elements each defining multiple leaves stacked together with at least one of said leaflet valve elements having three or more leaves with said leaves of each of said leaflet valve elements oriented such that said leaves are disaligned to enhance sealing of said valve.

8. An implantable infusion port according to claim 7 further comprising at least one ring valve element placed on one said of said leaflet valve elements.

9. An implantable infusion port according to claim 8 wherein said ring valve element is positioned on the side of said leaflet valve elements confronting said exit passageway.

10. An implantable infusion port according to claim 8 wherein said ring valve element is positioned on the side of said leaflet valve elements confronting said entrance orifice focus area.

11. An implantable infusion port according to claim 8 further comprising a spacer ring placed between said leaflet valve elements and said ring valve element.

12. An implantable infusion port according to claim 1 wherein said valve means imposes less friction upon said filament being inserted through said valve means than imposed upon said filament upon withdrawal of said filament.

13. An implantable infusion port for allowing the introduction of a flexible filament such as a catheter wire or optical fiber into a patient and being accessed using a needle which penetrates the patient'"'"'s skin with said filament being introduced into the port by said needle, comprising:

a housing having a generally funnel shaped entrance orifice having a focus area and defining a surface having a first included cone angle around the outer perimeter of said entrance orifice and defining a second included cone angle adjacent said focus area smaller than said first included cone angle, said surface of said entrance orifice being formed of a hard material enabling said needle upon contacting said entrance orifice to be guided toward said focus area, and

means for mounting said port subcutaneously.

14. An implantable infusion port according to claim 13 wherein said first and second included cone angles are defined by joined conical surfaces.

15. An implantable infusion port according to claim 13 further comprising an articulating catheter valve within said housing for permitting said filament to pass into an entrance passageway and through said valve and to an exit passageway while restricting the flow of fluids across said valve when said filament is removed from said port.

16. An implantable infusion port according to claim 15 wherein said housing further defines stop means within said entrance passageway for restricting said needle from engaging said articulating catheter valve.

17. An implantable infusion port according to claim 16 wherein said stop means comprises a bend in said entrance passageway.

18. An implantable infusion port according to claim 13 wherein said housing entrance orifice has a central axis generally perpendicular to the patient'"'"'s skin and further defines a projection which can be detected by external palpation after said port is implanted which indicates the orientation of said port.

19. An implantable infusion port according to claim 15 wherein said articulating catheter valve includes at least two leaflet valve elements each defining multiple leaves stacked together with at least one of said leaflet valve elements having three or more leaves with said leaves of each of said leaflet valve elements oriented such that they are disaligned to enhance sealing of said valve.

20. An implantable infusion port according to claim 19 further comprising at least one ring valve element placed on one side of said leaflet valve elements.

21. An implantable infusion port according to claim 19 further comprising a ring valve element positioned on the side of said leaflet valve elements confronting said exit passageway.

22. An implantable infusion port according to claim 20 wherein said ring valve element is positioned on the side of said leaflet valve elements confronting said entrance orifice focus area.

23. An implantable infusion port according to claim 20 further comprising a spacer ring placed between said leaflet valve elements and said ring valve element.

24. An implantable infusion port according to claim 15 wherein said valve imposes less friction upon said filament being inserted through said valve than imposed upon said filament upon withdrawal of said filament.

25. An implantable infusion port for allowing the introduction of a flexible filament such as a catheter wire or optical fiber into a patient and being accessed using a needle which penetrates the patient'"'"'s skin with said filament being introduced into the port by said needle, comprising:

a housing defining a generally funnel shaped entrance orifice leading to a focus area,

an entrance passageway formed by said housing extending from said focus area to a valve chamber and to an exit passageway communicating with a preselected site within the patient,

a valve installed within said valve chamber for permitting the passage of said filament while resisting the flow of fluids across said valve when said filament is removed from said port, and said valve having at least two leaflet valve elements each having three or more leaves, with at least one ring valve element stacked against one of said leaflet valve elements.

26. An implantable infusion port according to claim 25 wherein said ring valve element is positioned between said leaflet valve elements and said entrance orifice to aid in guiding said filament through said valve.

27. An implantable infusion port according to claim 25 wherein said ring valve element is positioned between said leaflet valve elements and said exit passageway against said leaflet valve elements for supporting said leaflet valve element leaves.

28. An implantable infusion port according to claim 25 wherein said ring valve element is positioned between said leaflet valve elements and said exit passageway and is spaced from said leaflet valve elements to permit said leaves of said leaflet valve elements to freely deflect upon insertion of said filament.

29. An implantable infusion port according to claim 25 comprising first and second ring valve elements positioned between said leaflet valve elements and said exit passageway wherein said first ring valve element supports said leaves of said leaflet valve elements and said second ring valve element defines a perimeter seal around said filament.

30. An implantable infusion port according to claim 25 wherein said valve further comprising a flapper valve element.

31. An implantable infusion port according to claim 25 further comprising stop means within said entrance passageway between said focus area and said valve chamber for restricting the passage of said needle while permitting said introduced filament to pass through said entrance passageway and engage said valve.

32. An implantable infusion port according to claim 31 wherein said stop means comprises a bend in said entrance passageway.

33. An implantable infusion port according to claim 25 wherein said entrance orifice defines a surface having a first included cone angle around the outside perimeter of said entrance orifice and defining a second included cone angle around said focus area which is smaller than said first included cone angle.

34. An implantable infusion port according to claim 33 wherein said first and second included cone angles are defined by joined conical surfaces.

35. An implantable infusion port according to claim 25 wherein said housing means entrance orifice has a central axis generally perpendicular to the patient'"'"'s skin and further defines a projection which can be detected by external palpation after said port is implanted which indicates the orientation of said port.

36. An implantable infusion port according to claim 25 wherein said valve imposes less friction upon said filament being inserted through said valve than imposed upon said filament upon withdrawal of said filament.

37. An implantable infusion port for allowing the introduction of a flexible filament such as a catheter, wire or optical fiber into a patient and being accessed using a needle which penetrates the patient'"'"'s skin with said filament being introduced into the port by said needle, comprising:

a housing having an entrance orifice for receiving said filament, and

valve means for permitting said filament to pass through said housing but restricting the flow of fluids across said valve means when said filament is removed from said port, said valve means further for imposing greater friction on said filament upon removal of said filament from said port as compared with insertion of said filament.

38. An implantable infusion port according to claim 37 wherein said valve means includes at least one leaflet valve element having leaves which deflect when said filament is placed through said valve means, and means for allowing said leaves to deflect more readily in the direction of insertion of said filament as compared to removal of said filament.

39. An implantable infusion port for allowing the introduction of a flexible filament such as a catheter wire or optical fiber into a patient and being accessed using a needle which penetrates the patient'"'"'s skin with said filament being introduced into the port by said needle, comprising:

housing means defining an enlarged generally funnel shaped entrance orifice defining a central axis which intersects with a narrowed down focus area of said orifice,

valve means within said housing for permitting said filament to pass through said valve means while restricting the flow of fluids across said valve means when said filament is removed, and

mounting means for mounting said port subcutaneously, said mounting means defining a mounting plane, and wherein said entrance orifice central axis forms an acute angle with respect to said mounting plane for facilitating access to said port by said needle.