Implantable infusion device - Patent Review 5053013

Claims

We claim:

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 pas