Vascular access fistula

• US 4,822,341 A
• Filed: 11/20/1987
• Issued: 04/18/1989
• Est. Priority Date: 11/20/1987
• Status: Expired due to Term

• Current Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Original Assignee: IMPRA Incorporated (Becton, Dickinson & Co)
• Inventors: Colone, William M.
• Primary Examiner(s): Pellegrino, Stephen C.
• Application Number:
  US07/123,339
• Time in Patent Office: 515 Days
• Field of Search: 604/175, 604/52, 604/4, 604/8, 604/9, 604/249, 604/256, 604/280, 604/33
• US Class Current: 604/175
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae

Abstract

A vascular access fistula includes a smooth, continuous PTFE tube having a hard sintered tube section integrally joined at its opposing ends with expanded PTFE tube sections. Inlet and outlet access port holes are formed in the hard sintered tube section to provide acute access to the fistula. A port collar surrounds the hard sintered tube section to facilitate the attachment of dual lumen tubing thereto. Following implantation of the access fistula, the dual lumen tubing temporarily extends through the skin to provide acute access while the access fistula heals. The port collar houses a slide valve which selectively couples the inlet and outlet access port holes to the dual lumen tubing for acute access. After the access fistula has healed, the slide valve is closed, the dual lumen tubing is cut off from the port collar, and chronic vascular access is provided by percutaneous cannulation of the implanted PTFE tube.

Claims

1. An access device for implantation in a living body to facilitate access to a fluid path within the living body, said access device comprising in combination:

a. a hard sintered unexpanded PTFE tube section having first and second opposing ends and having a tubular wall;

b. at least one access port hole formed in the tubular wall of said hard sintered unexpanded PTFE tube section for permitting access to the interior thereof;

c. first and second expanded PTFE tube sections each having first and second opposing ends, the first end of said first expanded PTFE tube section being integrally joined with the first end of said hard sintered unexpanded PTFE tube section, and the first end of said second expanded PTFE tube section being integrally joined with the second end of said hard sintered unexpanded PTFE tube section;

d. said first and second expanded PTFE tube sections and said hard sintered unexpanded PTFE tube section collectively providing a PTFE tube having a smooth continuous lumen; and

e. access means coupled to said hard sintered unexpanded PTFE tube section for establishing a fluid path between the at least one access port hole and a point external to the living body.

2. An access device for implantation within a fluid path of a living body, said access device being intended to be implanted at least partially below an outer skin of the living body, said access device comprising in combination:

a. a PTFE tube including;

i. a hard sintered unexpanded PTFE tube section having first and second opposing ends and having a tubular wall;

ii. at least one access port hole formed in the tubular wall of said hard sintered unexpanded PTFE tube section for permitting access to the interior of said PTFE tube through the tubular wall of said hard sintered unexpanded PTFE tube section; and

iii. first and second unexpanded PTFE tube sections each having first and second opposing ends, the first end of said first unexpanded PTFE tube section being integral with the first end of said hard sintered unexpanded PTFE tube section, and the first end of said second expanded PTFE tube section being integral with the second end of said hard sintered unexpanded PTFE tube section;

iv. said first and second expanded PTFE tube sections and said hard sintered unexpanded PTFE tube section collectively providing a PTFE tube having a smooth continuous lumen; and

b. a port collar secured to said hard sintered unexpanded PTFE tube section, said port collar having at least one hole formed therein in fluid communication with said at least one access port hole formed in the tubular wall of said hard sintered unexpanded PTFE tube section for permitting fluid access to said smooth continuous lumen.

3. An access device as recited by claim 2 wherein said port collar extends around the tubular wall of said hard sintered unexpanded PTFE tube section, said port collar having a central bore receiving said hard sintered unexpanded PTFE tube section and being sealingly engaged therewith.

4. An access device as recited by claim 3 wherein said port collar is formed from a durometer implantable plastic material.

5. An access device as recited by claim 4 wherein said port collar is formed of a soft polyurethane.

6. An access device as recited by claim 2 further including a flexible tube having at least one lumen, said flexible tube having first and second opposing ends, the first end of said flexible tube being coupled to said port collar for coupling said at least one lumen of said flexible tube to said at least one hole formed in said port collar in order to establish fluid communication between said at least one lumen of said flexible tube and said PTFE tube, said flexible tube being adapted to extend through the skin of the living body to facilitate access to said fluid path of the living body via the second end of said flexible tube.

7. An access device as recited by claim 6 wherein said flexible tube is formed of soft plastic.

8. An access device as recited by claim 6 wherein:

a. said hard sintered unexpanded PTFE tube section has a second access port hole formed in the tubular wall thereof for permitting access to the interior of said PTFE tube, said second access port hole being spaced apart from said at least one access port hole;

b. said port collar having a second hole formed therein in fluid communication with said second access port hole for permitting fluid access to said smooth continuous lumen; and

c. said flexible tube including a second lumen, the first end of said flexible tube coupling the second lumen to said second hole formed in said port collar in order to establish fluid communication between the second lumen of said flexible tube and said PTFE tube.

9. An access device as recited by claim 8 wherein the second end of said flexible tube includes first and second connectors coupled with said at least one lumen and said second lumen, respectively, for establishing independent fluid connections thereto.

10. An access device as recited by claim 8 wherein said port collar includes valve means for selectively interrupting fluid communication between said at least one lumen of said flexible tube and said at least one access port hole, and simultaneously interrupting fluid communication between said second lumen of said flexible tube and said second access port hole.

11. An access device as recited by claim 6 wherein said port collar includes valve means for selectively interruping fluid communication between said at least one lumen of said flexible tube and said at least one access port hole formed in the tubular wall of said hard sintered unexpanded PTFE tube section

12. An access device as recited by claim 11 wherein said port collar is adapted to be implanted entirely below the skin.

13. An access device as recited by claim 11 wherein said port collar includes a tubular connector extending therefrom to receive the first end of said flexible tube, said tubular connector being in fluid communication with said at least one hole formed in said port collar, said tubular connector being adapted to be cut off from said port collar below the skin after said valve means is closed to interrupt fluid communication between said at least one lumen of said flexible tube and said at least one access port hole.

14. An access device as recited by claim 11 wherein said port collar is formed of an implantable plastic material, and wherein said port collar is molded around the first end of said flexible tube to establish fluid communication between said at least one lumen of said flexible tube and said at least one hole formed in said port collar, said first end of said flexible tube being adapted to be cut off from said port collar substantially flush therewith after said valve means is closed.

15. An access device as recited by claim 13 wherein said port collar is adapted to be implanted entirely below the skin.

16. An access device for implantation within a fluid path of a living body, said access device being intended to be implanted at least partially below an outer skin of the living body, said access device comprising in combination:

a. a PTFE tube having predetermined outer diameter and including;

i. a hard sintered unexpanded PTFE tube section having first and second opposing ends and having a tubular wall;

ii. first and second access port holes formed in the tubular wall of said hard sintered unexpanded PTFE tube section for permitting access to the interior of said PTFE tube through the tubular wall of said hard sintered unexpanded PTFE tube section;

iii. first and second unexpanded PTFE tube sections each having first and second opposing ends, the first end of said first unexpanded PTFE tube section being integral with the first end of said hard sintered unexpanded PTFE tube section, and the first end of said second expanded PTFE tube section being integral with the second end of said hard sintered unexpanded PTFE tube section;

iv. said first and second expanded PTFE tube sections and said hard sintered unexpanded PTFE tube section collectively providing a PTFE tube having a smooth continous lumen; and

b. a port collar having a generally cylindrical shape and having a first longitudinal circular bore of a diameter commensurate with the predetermined outer diameter of said PTFE tube, said port collar being secured to said PTFE tube with said hard sintered PTFE tube section being disposed substantially within said first longitudinal circular bore, said port collar having first and second holes formed therein in fluid communication with said first and second access port holes, respectively; and

c. flexible tube means having first and second ends and having first and second lumens extending between said first and second ends thereof, the first end of said flexible tube means being coupled to said port collar for establishing fluid communication between the first lumen and the first access port hole and between the second lumen and the second access port hole, the flexible tube means being adapted to extend through the skin of the living body to facilitate access to the fluid path of the living body via the second end of said flexible tube means.

17. An access device as recited by claim 16 wherein the second end of said flexible tube means includes first and second connectors coupled with said first and second lumens, respectively, for establishing independent fluid connections thereto.

18. An access device as recited by claim 16 wherein said port collar includes valve means for selectively interrupting fluid communication between said first lumen and said first access port hole, and simultaneously interrupting fluid communication between said second lumen and said second access port hole.

19. An access device as recited by claim 18 wherein said port collar has a second longitudinal bore formed therein parallel to said first longitudinal bore, said second longitudinal bore having predetermined cross-sectional dimensions;

the first and second holes formed in said port collar communicating with said second longitudinal bore, and said valve means including an elongated member having cross-sectional dimensions commensurate with said predetermined cross-sectional dimensions of said second longitudinal bore for permitting said elongated member to slide within said second longitudinal bore, said elongated member having first and second transverse passageways formed therein, said elongated member adapted to assume a first opened positioned wherein said first and second passageways are in alignment with the first and second holes in said port collar to provide fluid communication between said first and second lumens and the first and second access port holes, respectively, and being adapted to assume a second closed position wherein said first and second passageways are out of alignment with the first and second holes in said port collar to seal said first and second lumens from said first and second access port holes, respectively.

20. An access device as recited by claim 18 wherein said flexible tube means is adapted to be cut off from said port collar below the skin, proximate to the first end of said flexible tube means, after said valve means is moved to its closed position to interrupt fluid communication between said first and second lumens and said first and second access port holes, respectively.

21. A method of providing access to the blood flow system of a living body, said method comprising the steps of:

a. creating a first incision through the skin of the living body;

b. implanting through such first incision an access fistula including;

i. an implantable graft having a relatively rigid tube section surrounded by and continuous with first and second opposing pliable tube sections, the relatively rigid tube section having at least one access port hole formed in the tubular wall thereof;

ii. a flexible access tube having a first end disposed proximate to the relatively rigid tube section of the implantable graft and having an opposing second end; and

iii. a valve disposed between the relatively rigid tube section of the implantable graft and the first end of the flexible access tube, the valve having an opened position for selectively providing fluid communication between the flexible access tube and the at least one access port hole, and having a closed position for selectively sealing the flexible access tube from the at least one access port hole;

c. joining the first and second opposing pliable tube sections of the implantable graft with an artery and a vein, respectively, of the blood flow system of the living body to establish a flow of blood through the implantable graft;

d. insuring that the valve is initially in its opened position;

e. closing the first incision over the access fistula while permitting the flexible access tube to extend outwardly through the first incision with the second end of the flexible access tube external from the living body;

f. temporarily accessing the blood flow system of the living body via the second end of the flexible access tube to permit ingrowth of body tissues into the implantable graft;

g. creating a second incision proximate the valve of the implantable graft to permit access to the valve after awaiting the ingrowth of body tissues into the implantable graft;

h. moving the valve to its closed position;

i. cutting off the flexible access tube from the implantable graft, and removing the flexible access tube from the living body;

j. closing the second incision leaving the implantable graft and valve implanted below the skin; and

k. thereafter accessing the blood flow system via the percutaneous cannulation of the implantable graft.

22. A method as recited by claim 21 wherein the implantable graft is made from PTFE, the relatively rigid tube section being hard sintered unexpanded PTFE, and the first and second pliable tube sections being expanded PTFE integrally joined with the hard sintered unexpanded PTFE tube section.