US 4,822,341 A · Vascular access fistula

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.

Claims22

Dependent claims

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.

3 more elements

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.

5 more elements

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.

6 more elements

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.

13 more elements

Dependencies are inferred from the claim text.

Vascular access fistula

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Vascular access fistula

Life of this patent

Abstract

Claims22