Method and systems for establishing vascular access

• US 6,238,369 B1
• Filed: 06/15/1999
• Issued: 05/29/2001
• Est. Priority Date: 01/21/1997
• Status: Expired due to Term

• Current Assignee: Vasco Data Security Incorporated (OneSpan, Inc.)
• Original Assignee: Vasco Data Security Incorporated (OneSpan, Inc.)
• Inventors: Beathard, Gerald, Buffaloe, George W., Brugger, James M., Burbank, Jeffrey H., Finch, Charles D.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US09/333,728
• Time in Patent Office: 714 Days
• Field of Search: 604/93, 604/284, 604/905, 604/264, 604/533-535
• US Class Current: 604/93.01
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2205/195 by the needle tip shape
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• 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 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Abstract

A body lumen access system comprises a distal access cannula and a proximal access cannula. The distal access cannula is attached to or within the body lumen and the proximal access cannula is attached to an implantable port or is transcutaneously positioned and attached to a luer or other external connector. The distal and proximal access cannulas are usually implanted separately, cut to length, and attached at a subcutaneous junction location. Preferably, the proximal access cannula has a larger lumen diameter than that of the distal access cannula in order to reduce flow resistance within the cannula system. In some cases the distal and proximal access cannulas may be formed integrally.

Claims

1. A system for establishing access to a body lumen in a patient, said system comprising:

an implantable port;

a distal access cannula having a distal end, a proximal end, and a lumen therethrough, wherein the distal end of the distal access cannula is adapted for connection to the body lumen to provide fluid communication between the body lumen and the distal cannula lumen;

a proximal access cannula having a distal end, a proximal end, and a lumen therethrough, wherein a proximal end of the proximal access cannula is adapted for connection to the implantable port to provide fluid communication between the port and the proximal cannula lumen; and

subcutaneously implantable means for directly connecting the proximal end of the distal catheter to the distal end of the proximal catheter to establish fluid communication between their respective lumens, wherein the implantable means directs all fluid exiting the distal end of the proximal access cannula to the proximal end of the distal access cannula.

2. A system as in claim 1, wherein the implantable means for directly connecting comprises a body having a first attachment aperture, a second attachment aperture, and an unobstructed continuous lumen therethrough.

3. A system as in claim 2, wherein the first and second attachment apertures are disposed at a relative angle in the range from 45°

to 270°

.

4. A system as in claim 3, wherein the relative angle is in the range from 90°

to 180°

.

5. A system as in claim 2, wherein the body has an U-shape so that the first and second attachment apertures are disposed in a parallel orientation and the lumen follows a 180 degree turn therethrough.

6. A system as in claim 5, wherein the implantable means further comprises a web connecting a portion of the body near the first attachment aperture to a portion of the body near the second attachment aperture.

7. A system as in claim 1, wherein at least a distal portion of the lumen in the distal access cannula is smaller than the lumen in the proximal access cannula.

8. A system as in claim 7, wherein the lumen in the distal access cannula has a uniform diameter along its entire length, wherein the proximal access cannula has a uniform diameter along its entire length, and wherein the proximal access cannula diameter is larger than the distal access cannula lumen.

9. A system as in claim 8, wherein the proximal access cannula lumen has a diameter in the from 1 mm to 6 mm and the distal access cannula lumen has a diameter in the range from 3 mm to 10 mm.

10. A system as in claim 7, wherein a distal portion of the lumen of the distal access cannula has a diameter which is less than that of a proximal portion thereof.

11. A system as in claim 10, wherein the distal portion has a length in the range from 5 cm to 45 cm.

12. A system as in claim 1, wherein the distal access catheter has a plurality of apertures near its distal end adapted for fluid inflow or outflow.

13. A system as in claim 1, wherein the distal access cannula has a pigtail shape.

14. A system as in claim 13, wherein the distal access cannula is adapted for peritoneal dialysis and further comprises a cuff for implantation in the peritoneal wall.

15. A system as in claim 1, wherein the distal access cannula comprises an axial tubular body and a cross-tube located at its distal end.

16. A system as in claim 15, wherein the distal access cannula further comprises a valve.

17. A system as in claim 1, wherein the distal access cannula comprises a tubular member terminating at its distal end in a suturing cuff.

18. A system as in claim 17, wherein the distal access cannula further comprises a valve.

19. A system as in claim 1, wherein the implantable port includes an access tube actuated valve.

20. A kit comprising:

a system comprising a distal access cannula and a proximal access cannula;

instructions for use setting forth a method as follows;

implanting the distal access cannula between the body lumen and a subcutaneous junction location;

implanting the proximal access cannula between the subcutaneous junction location and a catheter connection location;

adjusting the length of at least one of the distal access cannula and the proximal access cannula;

connecting a proximal end of the distal access cannula to a distal end of the proximal access cannula at the subcutaneous junction location; and

a package containing the system and instructions.

21. A kit as in claim 20, wherein the system is sterile within the package.