Hemodialysis access device

• US 5,704,915 A
• Filed: 02/14/1995
• Issued: 01/06/1998
• Est. Priority Date: 02/14/1995
• Status: Expired due to Fees

• Current Assignee: Arrow International Incorporated (Teleflex Incorporated)
• Original Assignee: Therex Limited Partnership
• Inventors: Prosl, Frank R., Melsky, Gerald S.
• Primary Examiner(s): Rimell, Sam
• Application Number:
  US08/388,530
• Time in Patent Office: 1,057 Days
• Field of Search: 604/93, 604/164, 604/175, 604/280, 604/283, 604/284
• US Class Current: 604/175
• CPC Class Codes: A61M 2039/0054 Multiple layers
• CPC Class Codes: A61M 2039/0072 Means for increasing tightness of the septum, e.g. compression rings, special materials, special constructions
• CPC Class Codes: A61M 2039/0211 with multiple chambers in a single site
• 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 vascular access device for hemodialysis comprises a pair of similar, generally conical, hollow shells, each shell having a relatively large entrance end and a relatively small exit end and an axis extending between the ends, the shells being connected together along a line of tangency. A pair of self-sealing septa close the entrance ends of the shells, and a pair of integral outlet tubes extend from the exit ends of the pair of shells, the distal ends of the outlet tubes being spaced apart and disposed parallel to the line of tangency.

Claims

1. A vascular access device for hemodialysis, comprising:

a pair of similar, generally conical, hollow shells, each shell having an entrance end and a smaller exit end defining a smoothly converging flow passage therebetween, and an axis extending between said ends;

means for connecting said pair of shells together along a common line of tangency, each of said shells being disposed with said axis at an acute angle relative to said common line of tangency;

a pair of self-sealing septa closing said entrance ends of said pair of shells; and

a pair of outlet tubes having corresponding first ends respectively extending from said exit ends of said pair of shells, said first ends of said pair of outlet tubes being spaced apart and disposed parallel to said line of tangency, such that when blood flows through each of said shells it follows said smoothly converging flow passage along said axis between said entrance end and said exit end of said shell, and undergoes a change in direction equal to said acute angle as it passes into said respective outlet tube.

2. The device defined in claim 1 wherein said pair of septa are domed and protrude from their respective shell entrance ends.

3. The device defined in claim 1 and further including a pair of external suture rings mounted to said pair of shells.

4. The device defined in claim 1 wherein

said pair of shells are of titanium, and

said pair of septa are of silicone rubber.

5. The device defined in claim 1 and further including a flexible, dual-lumen catheter having one end attached to said opposite ends of said pair of outlet tubes so that the outlet tubes communicate with different lumens of the catheter.

6. The device defined in claim 1 and further including thromboresistant covers covering the internal surfaces of said pair of shells and said pair of outlet tubes.

7. The device defined in claim 6 wherein said covers are composed of carbon.

8. The device defined in claim 6 wherein the thromboresistant covers covering the internal surfaces of said pair of shells comprise conical self-supporting liners which conform to the internal shapes of said shells and fit snugly between the septa and outlet tubes of the respective shells.

9. The device defined in claim 8 wherein said liners are of pyrolitic carbon.

10. The device defined in claim 1 and further including a needle for accessing said device by piercing at least one of said pair of septa, said needle including

a cannula having a lumen;

a connector affixed to one end of the cannula;

a stylet sized to be received in and extend the entire length of said lumen, and

a stylet hub affixed to one end of the stylet, said hub and said connector including coacting coupling means for releasably securing said hub and said connector together when the stylet is received in the cannula lumen.

11. The device defined in claim 10 wherein the cannula is a 12 to 16 gage cannula.

12. The device defined in claim 1 wherein said pair of septa are each composed of a first layer of relatively high durometer resilient material and a second parallel layer of relatively low durometer resilient material.

13. The device defined in claim 11 wherein said layer of low durometer material is located inside the corresponding shell.

14. A vascular access device for hemodialysis comprising

a pair of similar generally conical hollow shells each shell having an entrance end and a smaller exit end;

means for connecting the pair of shells together;

a pair of self-sealing septa closing the entrance ends of said pair of shells;

a pair of outlet tubes having corresponding first ends extending from the exit ends of said pair of shells, and

thromboresistant covers covering the internal surfaces of said pair of shells and said pair of outlet tubes.

15. The device defined in claim 14 wherein the thromboresistant covers covering the internal surfaces of said pair of shells comprise conical self-supporting liners which conform to the internal shapes of said shells and fit snugly between the septa and outlet tubes of the respective shells.

17. The device defined in claim 14 wherein the thrombo-resistant covers are composed or carbon material.

18. The device defined in claim 17 wherein said carbon material is pyrolitic carbon.

16. A vascular device, comprising:

a pair of similar generally conical, hollow shells, each shell having an entrance end and a smaller exit end defining a smoothly converging flow passage therebetween, and an axis extending between said entrance end and said exit end;

means for connecting said pair of shells together along a common line of tangency, each of said shells being disposed with said axis at an acute angle relative to said common line of tangency;

each shell having a self-sealing septum closing said shell entrance, said septum being composed of at least two layers of different durometer rubber-like materials; and

a pair of outlet tubes having corresponding first ends respectively extending from said exit ends of said pair of shells said first ends of said pair of outlet tubes being spaced apart and disposed parallel to said line of tangency, such that when blood flows through each of said shells it follows said smoothly converging flow passage along said axis between said entrance end and said exit end of said shell, and undergoes a change in direction equal to said acute angle as it passes into said respective outlet tube.

19. The device defined in claim 16 wherein said layer of low durometer material is located within the shell.