Implantable infusion device

• US 5,053,013 A
• Filed: 06/18/1990
• Issued: 10/01/1991
• Est. Priority Date: 03/01/1990
• Status: Expired due to Term

• Current Assignee: James A. Knol, James C. Andrews, William D. Ensminger
• Original Assignee: Board of Regents of the University of Michigan (University of Michigan)
• Inventors: Knol, James A., Andrews, James C., Ensminger, William D.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US07/539,793
• Time in Patent Office: 470 Days
• Field of Search: 604/167, 604/175, 604/93, 604/86, 604/244, 604/256, 604/283, 604/4, 604/8-10, 604/49, 604/905, 128/DIG. 26
• US Class Current: 604/167.04
• CPC Class Codes: A61M 2039/0211 with multiple chambers in a single site
• CPC Class Codes: A61M 2039/0223 having means for anchoring the subcutaneous access 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 2039/0686 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

In infusion port for implantation within a patient for providing repeated access to specific tissue within a patient and communicating with the tissue by an internal implanted catheter. The infusion port in accordance with this invention includes a housing having a funnel shaped inlet orifice which terminates in a reduced diameter guide passageway. Installed within the housing is an articulating catheter valve such as a leaflet valve assembly. The housing communicates with an exit passageway which is attached to an internal outflow catheter coupling the infusion port to a specific tissue within the patient. In use, a needle is used to penetrate the patient'"'"'s skin and contacts the entrance orifice of the infusion port. The entrance orifice guides the needle point into alignment with and into the guide passageway. The guide passageway targets a small portion of the articulating catheter valve which can be in the form of a leaflet valve assembly. Once through the catheter valve, fluids may be infused into the patient through the needle or withdrawn from the patient. Alternatively, an external catheter or other filament can be placed in communication with the outflow catheter by feeding it in into the infusion port and into the implanted catheter after being introduced over a needle which is restricted from entering the implanted catheter.

Claims

1. An implantable patient access device for permitting access to an implanted internal catheter using a needle and enabling the introduciton of a flexible filament such as an external catheter, wire or optical fiber, comprising:

housing means defining a entrance orifice having a decreasing cross-sectional area and having a surface formed of a hard material for guiding said needle upon contacting said entrance orifice into a guide passageway within said housing means, said housing means further defining an exit orifice for attachment of said internal catheter,

an articulating catheter valve within said housing means which normally remains closed to provide resistance to flow of fluids through said valve, yet opens when penetrated by said needle enabling said needle to communicate with said internal catheter wherein said guide passageway guides and orients said needle to strike said catheter valve at a predetermined area, and

mounting means formed by said housing means for affixing said housing means subcutaneously.

2. An implantable patient access device according to claim 1 wherein said catheter valve comprises a leaflet valve having at least two elastic disc elements stacked together.

3. An implantable patient access device according to claim 2 wherein said disc elements having slits therethrough and each defining three or more deflectable valve leaves and wherein said guide passageway causes said needle to strike said disc elements at near the geometric center of said cuts.

4. An implantable patient access device according to claim 3 wherein said disc elements are stacked together such that said slits of a first of said disc element are not aligned with said slits of a second of said disc elements.

5. An implantable patient access device according to claim 3 wherein said guide passageway has a diameter not greater than one-half of the diameter of said elastic disc element portions defining said leaves.

6. An implantable patient access device according to claim 2 wherein said housing means further defines an internal cavity within which said leaflet valve is disposed.

7. An implantable patient access device according to claim 6 wherein said internal cavity provides clearance for said valve leaves to deflect toward said exit orifice.

8. An implantable patient access device according to claim 6 wherein said internal cavity provides clearance for said valve leaves to deflect toward said entrance orifice.

9. An implantable patient access device according to claim 6 wherein said housing means is defined by a main housing defining said entrance orifice and said guide passageway and an outlet plug connected with said main housing defining said exit orifice, said main housing and said outlet plug cooperating to define said internal cavity.

10. An implantable patient access device according to claim 1 wherein said housing means defines means to limit the amount of penetration of said needle in said housing means while allowing more flexible introduced filaments to be threaded entirely through said access device.

11. An implantable patient access device according to claim 10 wherein said means to limit the amount of penetration comprises a curved passageway which defines the limit of said penetration.

12. An implantable patient access device according to claim 2 wherein said leaflet valve further comprises a disc element having a hole for sealing against said filament.

13. An implantable patient access device according to claim 12 wherein said disc element having a hole is placed such that said needle passes through said element with a hole before passing through said leaflet valve elastic disc elements.

14. An implantable patient access device according to claim 1 further comprising an external catheter having said needle inserted into its hollow core and said access device allowing the combination of said needle and said external catheter to be inserted into said access device and thereafter allowing said needle to be removed leaving said external catheter inside said access device.

15. An implantable patient access device for communicating to a desired tissue site within the patient through an implanted internal catheter and accessible using a needle for enabling the introduction of a flexible filament such as an external catheter, wire or optical fiber, comprising:

a housing defining a entrance orifice having a decreasing cross-sectional area and having a surface formed of a hard material for guiding said needle upon contacting said entrance orifice into a straight guide passageway within said housing, and defining an internal cavity communicating with said guide passageway and an exit orifice,

a leaflet valve assembly positioned within said internal cavity and including at least two elastic disc elements stacked together, each of said disc elements having slits formed therethrough and defining a plurality of deflectable valve leaves, said disc elements stacked together such that said slits in each of said disc elements are not aligned with said slits of the adjacent of said disc elements, and

mounting means formed by said housing for affixing said housing subcutaneously.

16. An implantable patient access device according to claim 15 wherein said disc elements define three or more valve leaves.

17. An implantable patient access device according to claim 15 wherein said guide passageway has a diameter not greater than one-half of the diameter of said elastic disc element portions defining said leaves.

18. An implantable patient access device according to claim 15 wherein said housing internal cavity provides clearance for said valve leaves to deflect toward said exit orifice.

19. An implantable patient access device according to claim 15 wherein said housing internal cavity provides clearance for said valve leaves to deflect toward said entrance orifice.

20. An implantable patient access device according to claim 15 wherein said housing includes a main housing defining said entrance orifice and said guide passageway and an outlet plug connected with said main housing defining said exit orifice, said main housing and said outlet plug cooperating to define said internal cavity.

21. An implantable patient access device according to claim 15 wherein said leaflet valve further comprises a disc element having a hole for sealing against an introduced filament.

22. An implantable patient access device according to claim 21 wherein said disc element having a hole is placed such that said needle passes through said element with a hole before passing through said leaflet valve elastic disc elements.

23. An implantable patient access device according to claim 15 wherein said housing defines means to limit the amount of penetration of said needle in said housing while allowing said flexible introduced filaments to be threaded entirely through said access device.

24. An implantable patient access device according to claim 23 wherein said means to limit the amount of penetration comprises a curved passageway which defines said limit of penetration.

25. An implantable patient access device according to claim 24 wherein said curved passageway allows said filament to be pushed through said curved passageway and into said implanted internal catheter.

26. An implantable patient access device according to claim 15 wherein said needle is placed through the hollow core of an external catheter and placed into said access device as a combination and wherein said needle may be withdrawn leaving said external catheter inside of said access device.

27. An implantable patient access device according to claim 15 wherein said needle allowing said filament to be fed into said access device after being introduced into said access device by said needle.

28. An implantable patient access device for infusion or withdrawal of a fluid through an implanted internal catheter communicating said device with a preselected site within the patient and accessible using a needle, comprising:

housing means defining a entrance orifice having a decreasing cross-sectional area for guiding said needle into a guide passageway within said housing means, said housing means further defining an exit orifice for attachment of said internal catheter and an internal cavity, and

a leaflet valve having at least two elastic disc elements stacked together within said housing internal cavity which normally remains closed to provide resistance to flow of fluids through said valve, yet opens when penetrated by said needle enabling said needle to communicate with said internal catheter wherein said guide passageway guides and orients said needle to strike said leaflet valve at a predetermined area, said internal cavity providing clearance for said valve leaves to deflect toward said exit orifice.

29. An implantable patient access device for infusion or withdrawal of a fluid through an implanted internal catheter communicating said device with a preselected site within the patient and accessible using a needle, comprising:

housing means defining a entrance orifice having a decreasing cross-sectional area for guiding said needle into a guide passageway within said housing means, said housing means further defining an exit orifice for attachment of said internal catheter and an internal cavity, and

a leaflet valve having at least two elastic disc elements stacked together within said housing internal cavity which normally remains closed to provide resistance to flow of fluids through said valve, yet opens when penetrated by said needle enabling said needle to communicate with said internal catheter wherein said guide passgeway guides and orients said needle to strike said leaflet valve at a predetermined area and wherein said internal cavity providing clearance for said valve leaves to deflect toward said entrance orifice.

30. An implantable patient access device for infusion for withdrawal of a fluid through an implanted internal catheter communicating said device with a preselected site within the patient and accessible using a needle, comprising:

housing means defining a entrance orifice having a decreasing cross-sectional area for guiding said needle into a guide passageway within said housing, said housing means further defining an exit orifice for attachment of said internal catheter, said housing defining means to limit the amount of penetration of said needle in said housing while allowing more flexible filaments or catheters to be threaded entirely through said infusion device, and

an articulating catheter valve within said housing means which normally remains closed to provide resistance to flow of fluids through said valve, yet opens when penetrated by said needle enabling said needle to communicate with said internal catheter wherein said guide passageway guides and orients said needle to strike said catheter valve at a predetermined area.

31. An implantable patient access device according to claim 30 wherein said means to limit the amount of penetration comprises a curved passageway which defines said limit of penetration.

32. An implantable patient access device communicating to a desired tissue site within the patient by an implanted internal catheter and accessible using a needle for enabling the infusion or withdrawal of fluid through the needle or through an introduced external catheter, comprising:

a housing defining a entrance orifice having a decreasing cross-sectional area for guiding said needle into a straight guide passageway within said housing, and defining an internal cavity communicating with said guide passageway and an exit orifice, and

a leaflet valve assembly positioned within said internal cavity and including at least two elastic disc elements stacked together, each of said disc elements having slits formed therethrough each defining a plurality of deflectable valve leaves, said disc elements stacked together such that said slits in each disc are not aligned with said slits of the adjacent of said discs and said housing internal cavity providing clearance for said valve leaves to deflect toward said exit orifice.

33. An implantable patient access device communicating to a desired tissue site within the patient by an implanted internal catheter and accessibly using a needle for enabling the infusion or withdrawal of fluid through the needle or through an introduced external catheter, comprising:

a housing defining a entrance orifice having a decreasing cross-sectional area for guiding said needle into a straight guide passageway within said housing, sand defining an internal cavity communicating with said guide passageway and an exit orifice, and

a leaflet valve assembly positioned within said internal cavity and including at least two elastic disc elements stacked together, each of said disc elements having slits formed therethrough each defining a plurality of deflectable valve leaves, said disc elements stacked together such that said slits in each disc are not aligned with said slits of the adjacent of said discs, said housing assembly internal cavity providing clearance for said valve leaves to deflect toward said entrance orifice.

34. An implantable patient access device communicating to a desired tissue site within the patient by an implanted internal catheter and accessible using a needle for enabling the infusion or withdrawal of fluid through the needle or through an introduced external catheter, comprising:

a housing defining a entrance orifice having a decreasing cross-sectional area for guiding said needle into a straight guide passageway within said housing, and defining an internal cavity communicating with said guide passageway and an exit orifice, said housing defining means to limit the amount of penetration of said needle in said housing while allowing more flexible introduced filaments or catheters to be threaded entirely through said device, and

a leaflet valve assembly positioned within said internal cavity and including at least two elastic disc elements stacked together, each of said disc elements stacked together such that said slits in each disc are not aligned with said slits of the adjacent of said discs.

35. An implantable patient access device according to claim 34 wherein said means to limit the amount of penetration comprises a curved passageway which defines the said limit of penetration.

36. An implantable patient access device according to claim 35 wherein said curved passageway allows said external catheter to be pushed through said curved passageway and into said implanted internal catheter.

37. An implantable patient access device for permitting access to an implanted internal catheter using a needle and enabling the introduction of a flexible filament such as an external catheter, wire or optical fiber comprising:

housing means defining a entrance orifice having a decreasing cross-sectional area and having a surface formed of a hard material for guiding said needle upon contacting said entrance orifice toward a guide passageway within said housing, said housing means further defining an exit orifice for connection to said internal catheter,

an articulating catheter valve within said housing means which normally remains closed to provide resistance to flow of fluids through said valve, yet opens for engagement with said filament enabling said filament to communicate with said internal catheter, and

mounting means formed by said housing means for affixing said housing subcutaneously.