Squitieri hemodialysis and vascular access systems

• US 20070123811A1
• Filed: 05/03/2006
• Published: 05/31/2007
• Est. Priority Date: 02/07/1997
• Status: Abandoned Application

• Current Assignee: Hemosphere, Inc. (Cryolife Incorporated)
• Original Assignee: Hemosphere, Inc. (Cryolife Incorporated)
• Inventors: Squitieri, Rafael
• Application Number:
  US11/417,658
• Publication Number:
  US 20070123811A1
• Time in Patent Office: Days
• US Class Current: 604/6.160
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2039/0211 with multiple chambers in a single site
• CPC Class Codes: A61M 2039/0258 for vascular access, e.g. blood stream access
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276

Abstract

A hemodialysis and vascular access system comprises a subcutaneous composite PTFE silastic arteriovenous fistula having an indwelling silastic venous end which is inserted percutaneously into a vein and a PTFE arterial end which is anastomosed to an artery. Access to a blood stream within the system is gained by direct puncture of needle(s) into a needle receiving site having a tubular passage within a metal or plastic frame and a silicone upper surface through which needle(s) are inserted. In an alternate embodiment of the invention, percutaneous access to a blood stream may be gained by placing needles directly into the system (i.e. into the PTFE arterial end). The invention also proposes an additional embodiment having an arterialized indwelling venous catheter where blood flows from an artery through a tube and a port into an arterial reservoir and is returned to a vein via a port and a venous outlet tube distinct and distant from the area where the blood from the artery enters the arterial reservoir. The site where blood is returned to the vein is not directly fixed to the venous wall but is free floating within the vein. This system provides a hemodialysis and venous access graft which has superior longevity and performance, is easier to implant and is much more user friendly.

Claims

1. A hemodialysis and vascular access system wherein:

said system comprises a first portion comprising a tube and a second portion comprising a catheter and wherein;

said tube is provided from a material which can be sutured to the artery with a first end of said tube adapted to be coupled to an artery; and

said catheter is adapted to be inserted within a vein at an insertion site, with a first end of the catheter having an opening adapted to be within the vein itself and wherein the opening in the first end of said catheter is distant from the insertion site and

said tube and said catheter being adapted to be entirely subcutaneous in use and

configured to avoid, in use, a reservoir therein.

2. The hemodialysis and vascular access system of claim 1, wherein said system has a single lumen formed by said tube and said catheter.

3. The hemodialysis and vascular access system of claim 1, wherein said first end of the catheter is adapted for percutaneous insertion.

4. The hemodialysis and vascular access system of claim 3, wherein said first end of the catheter is beveled.

5. The hemodialysis and vascular access system of claim 1, wherein a second end of the tube is adapted to be coupled to a second end of the catheter.

6. The hemodialysis and vascular access system of claim 5, wherein said second end of the catheter comprises an enlarged portion configured to lock with said second end of the tube.

7. The hemodialysis and vascular access system of claim 5, wherein said system further comprises a coupler adapted to join said second end of the tube to said second end of the catheter.

8. The hemodialysis and vascular access system of claim 5, wherein said second end of the tube is glued to said second end of the catheter.

9. The hemodialysis and vascular access system of claim 1, wherein said catheter comprises a cuff adapted for sewing to the vein.

10. The hemodialysis and vascular access system of claim 1, wherein said catheter comprises multiple layers of material.

11. The hemodialysis and vascular access system of claim 10, wherein at least one layer is a thrombus resistant coating.

12. The hemodialysis and vascular access system of claim 10, wherein said catheter further comprises an inner layer of PTFE material and an outer layer of silastic material.

13. The hemodialysis and vascular access system of claim 1, wherein the tube comprises a PTFE material and the catheter comprises a silastic material.

14. The hemodialysis and vascular access system of claim 1, wherein said system further comprises a needle receiving site located between said first end of the tube and said first end of the catheter.

15. The hemodialysis and vascular access system of claim 14, wherein the needle receiving site comprises a frame having a passage extending therethrough, an inlet adapted to connect to said second end of the tube, and an outlet adapted to connect to a second end of the catheter.

16. The hemodialysis and vascular access system of claim 1, wherein said system further comprises at least one needle having a first end configured to couple to a hemodialysis device and a second end adapted for insertion directly into said tube.

23. The hemodialysis and vascular access system of claims 1, wherein said catheter comprises a cuff adapted for sewing to the vein.

24. The hemodialysis and vascular access system of claim 1, wherein said catheter comprises multiple layers of material.

25. The hemodialysis and vascular access system of claim 24, wherein at least one layer is a thrombus resistant coating.

26. The hemodialysis and vascular access system of claim 24, wherein said catheter further comprises an inner layer of PTFE material and an outer layer of silastic material.

17. A hemodialysis and vascular access system to shunt blood between a vein and an artery, said system having a single lumen comprising:

a tube having first and second ends, said first end adapted to be anastomosed to said artery; and

a catheter, comprising tubing having a first end and a second end, said second end being connected to said second end of said tube;

said catheter having a site for entering said vein, said site being away from said first end of said catheter so that, in use, said first end can be located downstream in said vein;

and needle receiving sites between said first end of said tube and said first end of said catheter;

said tube and said catheter being adapted to be entirely subcutaneous in use and configured to avoid, in use, a blood reservoir therein and to provide continuous blood flow.

18. The hemodialysis and vascular access system of claim 17, wherein said first end of the catheter is adapted for percutaneous insertion in said vein.

19. The hemodialysis and vascular access system of claim 17, wherein said first end of the catheter is beveled.

20. The hemodialysis and vascular access system of claims 17, wherein said second end of the catheter comprises an enlarged portion configured to lock with said second end of the tube.

21. The hemodialysis and vascular access system of claim 17, wherein said system further comprises a coupler adapted to join said second end of the tube to said second end of the catheter.

22. The hemodialysis and vascular access system of claim 17, wherein said second end of the tube is glued to said second end of the catheter.

27. The hemodialysis and vascular access system of claim 17, wherein the material of said tube and said catheter comprise PTFE.

28. The hemodialysis and vascular access system of claim 17, wherein the material of said tube is PTFE and the material of said catheter is silastic.

29. The hemodialysis and vascular access system of claim 17, further comprising a needle receiving site between said first and second ends.

30. The hemodialysis and vascular access system of claim 29, wherein the needle receiving site comprises a frame having a passage extending therethrough, an inlet adapted to connect to said first portion of the tube, an outlet adapted to connect to said second portion of the tube.

31. The hemodialysis and vascular access system of claim 17, wherein said system further comprises at least one needle having a first end configured to couple to a hemodialysis device and a second end adapted for insertion directly into said system.

32. A hemodialysis and vascular access system, comprising:

an arterialized indwelling venous catheter having a first portion provided from a material which is biocompatible with an arterial system, has a nonthrombogenic characteristic, which is adapted for attachment to an arterial system and a catheter section, with a first end of said first portion adapted to be coupled to an arterial system and a portion of the catheter section adapted to be inserted within a venous system at an insertion site, said catheter section portion having an outside diameter which is less than an inner diameter of the venous system and having at least one opening in an end thereof with at least one of the at least one openings in the catheter section portion adapted to be within the venous system itself and wherein the at least one opening is distant from the insertion site such that, in operation, blood flows from the arterial system through the catheter and is returned to the venous system through the at least one opening and blood also flows through the vein uninterrupted around at least an outer portion of said catheter; and

at least one needle having a first end coupled to a hemodialysis device and having a second end adapted for insertion directly into the arterialized indwelling venous catheter to shunt the blood flow through the dialysis device.

33. The hemodialysis and vascular access system of claim 32 wherein the first portion of said arterialized indwelling venous catheter is provided from a first tube and said catheter section is provided from a second tube comprising multiple layers and a first end of said first tube is coupled to a first end of said second tube.

34. The hemodialysis and vascular access system of claim 33 wherein said first and second tubes are adapted for percutaneous placement.

35. The hemodialysis and vascular access system of claim 33 wherein the end of said second tube which is coupled to the first tube includes an enlarged portion in which the first end of said first tube is disposed.

36. A hemodialysis and vascular access system as in claim 32, wherein the first portion comprises PTFE.

37. A hemodialysis and vascular access system as in claim 32, wherein the first portion has a diameter of approximately 7 mm.

38. A hemodialysis and vascular access system as in claim 32, wherein the first end of the first portion has a diameter of about 4 mm.

39. A hemodialysis and vascular access system as in claim 32, wherein the catheter section comprises a silastic material.

40. A hemodialysis and vascular access system as in claim 32, wherein the catheter section comprises silicone.

41. A hemodialysis and vascular access system as in claim 32, wherein a downstream end of the catheter section is provided with a bevel.

42. A hemodialysis and vascular access system as in claim 32, additionally comprising an access segment for receiving a needle to allow access to blood flowing through the catheter.

43. A hemodialysis and vascular access system as in claim 33, wherein the access segment comprises a self sealing material.

44. A hemodialysis and vascular access system as in claim 43, wherein the self sealing material comprises silicone.

45. A hemodialysis and vascular access system as in claim 43, wherein the access segment is removably connected to the access system.

46. A hemodialysis and vascular access system as in claim 43, further comprising a frame in the access segment.