# US 5,700,287 A · Prosthetic vascular graft with deflectably secured fibers

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- Number: US 5,700,287 A
- Document ID: US5700287A
- Status: Granted
- Kind: A
- Application number: 08/743,954
- Filed: 1996-10-29
- Granted: 1997-12-23
- Earliest claimed: 1992-12-11
- Assignees: W. L. Gore & Associates, Inc.
- Inventors: David J. Myers; James D. Lewis; Carey V. Campbell
- Web page: https://patentgrep.com/patent/US5700287A

## CPC

- A61M 39/04: having pierceable self-sealing members
- A61F 2/06: Blood vessels
- A61L 27/507: {for artificial blood vessels (apparatus for applying cells on a blood vessel prosthesis A61F2/062)}
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

A vascular graft in the form of a tube or flat sheet of biocompatible material having an outer covering of deflectably secured material such as porous film, fibers, discrete pieces of material, or combinations thereof. Two different types of fibers may also be used. The vascular graft may be of tubular form for replacing or bypassing entire segments of veins or arteries or alternatively may be in the form of a flat sheet useful for repairing portions of the circumference of veins or arteries. The tube or flat sheet of biocompatible material and the outer covering of deflectably secured material are preferably of porous polytetrafluoroethylene. The inventive vascular graft is useful for dialysis access in that it offers a reduction in blood leakage when the vascular graft is punctured by a dialysis needle and the needle is subsequently removed. It is also useful for reducing suture hole bleeding resulting from holes created through the graft by penetration of the graft with a suture needle.

## Claims

### Claim 1

A prosthetic vascular graft comprising a base substrate of biocompatible material having an ablumenal surface wherein a substantial portion of the ablumenal surface is provided with an outer covering of deflectably secured material that is capable of being deflected with respect to the ablumenal surface of the base substrate, wherein said deflectably secured material is at least two different types of fibers and, wherein the deflectably secured material is secured to the base substrate in such a manner that a substantial portion of the deflectably secured material is not directly secured to the base substrate and a substantial portion of adjacent surfaces of the deflectably secured material are not directly secured to each other wherein said fibers are free to move with respect to each other within a length of the graft.

### Claim 2 (depends on 1)

A prosthetic vascular graft according to claim 1 wherein the at least two different types of fibers are of at least two different materials.

### Claim 3 (depends on 2)

A prosthetic vascular graft according to claim 2 wherein the at least two different materials are polyethylene terephthalate and polytetrafluoroethylene.

### Claim 4 (depends on 2)

A prosthetic vascular graft according to claim 2 wherein the at least two different materials are fluorinated ethylene propylene and polytetrafluoroethylene.

### Claim 5 (depends on 1)

A prosthetic vascular graft according to claim 1 wherein the at least two different types of fibers are of at least two different cross sectional shapes.

### Claim 6 (depends on 5)

A prosthetic vascular graft according to claim 5 wherein the at least two different cross sectional shapes are substantially round and oblong.

### Claim 7 (depends on 6)

A prosthetic vascular graft according to claim 6 wherein at least a portion of the base substrate at ambient temperature is capable of being stretched and rapidly recovering more than about 10 percent of its stretched length.

### Claim 8 (depends on 7)

A prosthetic vascular graft according to claim 7 having an exterior covering of porous polytetrafluoroethylene film.

### Claim 9 (depends on 7)

A prosthetic vascular graft according to claim 7 having a tubular exterior covering.

### Claim 10 (depends on 9)

A prosthetic vascular graft according to claim 9 wherein the tubular exterior covering is a tube having a wall thickness and having at least two macroscopic perforations through the wall thickness, said macroscopic perforations having a diameter of at least 0.2 mm.

### Claim 11 (depends on 10)

A prosthetic vascular graft according to claim 10 wherein the tube has been perforated by a laser.

### Claim 12 (depends on 10)

A prosthetic vascular graft according to claim 10 wherein the tubular exterior covering comprises a porous polytetrafluoroethylene tube.

### Claim 13 (depends on 11)

A prosthetic vascular graft according to claim 11 wherein the tubular exterior covering comprises a porous polytetrafluoroethylene tube.

### Claim 14 (depends on 9)

A prosthetic vascular graft according to claim 9 wherein the tubular exterior covering comprises a porous polytetrafluoroethylene tube.

### Claim 15 (depends on 6)

A prosthetic vascular graft according to claim 6 having an exterior covering of porous polytetrafluoroethylene film.

### Claim 16 (depends on 6)

A prosthetic vascular graft according to claim 6 having a tubular exterior covering.

### Claim 17 (depends on 16)

A prosthetic vascular graft according to claim 16 wherein the tubular exterior covering is a tube having a wall thickness and having at least two macroscopic perforations through the wall thickness, said macroscopic perforations having a diameter of at least 0.2 mm.

### Claim 18 (depends on 17)

A prosthetic vascular graft according to claim 17 wherein the tube has been perforated by a laser.

### Claim 19 (depends on 18)

A prosthetic vascular graft according to claim 18 wherein the tubular exterior covering comprises a porous polytetrafluoroethylene tube.

### Claim 20 (depends on 17)

A prosthetic vascular graft according to claim 17 wherein the tubular exterior covering comprises a porous polytetrafluoroethylene tube.

### Claim 21 (depends on 16)

A prosthetic vascular graft according to claim 16 wherein the tubular exterior covering comprises a porous polytetrafluoroethylene tube.

### Claim 22 (depends on 5)

A prosthetic vascular graft according to claim 5 wherein at least a portion of the base substrate at ambient temperature is capable of being stretched and rapidly recovering more than about 10 percent of its stretched length.

### Claim 23 (depends on 22)

A prosthetic vascular graft according to claim 22 having an exterior covering of porous polytetrafluoroethylene film.

### Claim 24 (depends on 22)

A prosthetic vascular graft according to claim 22 having a tubular exterior covering.

### Claim 25 (depends on 24)

A prosthetic vascular graft according to claim 24 wherein the tubular exterior covering is a tube having a wall thickness and having at least two macroscopic perforations through the wall thickness, said macroscopic perforations having a diameter of at least 0.2 mm.

### Claim 26 (depends on 25)

A prosthetic vascular graft according to claim 25 wherein the tube has been perforated by a laser.

### Claim 27 (depends on 26)

A prosthetic vascular graft according to claim 26 wherein the tubular exterior covering comprises a porous polytetrafluoroethylene tube.

### Claim 28 (depends on 25)

A prosthetic vascular graft according to claim 25 wherein the tubular exterior covering comprises a porous polytetrafluoroethylene tube.

### Claim 29 (depends on 24)

A prosthetic vascular graft according to claim 24 wherein the tubular exterior covering comprises a porous polytetrafluoroethylene tube.

### Claim 30 (depends on 5)

A prosthetic vascular graft according to claim 5 having an exterior covering of porous polytetrafluoroethylene film.

### Claim 31 (depends on 5)

A prosthetic vascular graft according to claim 5 having a tubular exterior covering.

### Claim 32 (depends on 31)

A prosthetic vascular graft according to claim 31 wherein the tubular exterior covering is a tube having a wall thickness and having at least two macroscopic perforations through the wall thickness, said macroscopic perforations having a diameter of at least 0.2 mm.

### Claim 33 (depends on 32)

A prosthetic vascular graft according to claim 32 wherein the tube has been perforated by a laser.

### Claim 34 (depends on 33)

A prosthetic vascular graft according to claim 33 wherein the tubular exterior covering comprises a porous polytetrafluoroethylene tube.

### Claim 35 (depends on 32)

A prosthetic vascular graft according to claim 32 wherein the tubular exterior covering comprises a porous polytetrafluoroethylene tube.

### Claim 36 (depends on 31)

A prosthetic vascular graft according to claim 31 wherein the tubular exterior covering comprises a porous polytetrafluoroethylene tube.

### Claim 37 (depends on 1)

A prosthetic vascular graft according to claim 1 wherein the at least two different types of fibers are first and second fibers of at least two different cross sectional dimensions wherein the first fiber has a dimension at least 1.5 times the same dimension of the second fiber.

### Claim 38 (depends on 1)

A prosthetic vascular graft according to claim 1 wherein at least a portion of the base substrate at ambient temperature is capable of being stretched and rapidly recovering more than about 10 percent of its stretched length.

### Claim 39 (depends on 38)

A prosthetic vascular graft according to claim 38 having an exterior covering of porous polytetrafluoroethylene film.

### Claim 40 (depends on 38)

A prosthetic vascular graft according to claim 38 having a tubular exterior covering.

### Claim 41 (depends on 40)

A prosthetic vascular graft according to claim 40 wherein the tubular exterior covering is a tube having a wall thickness and having at least two macroscopic perforations through the wall thickness, said macroscopic perforations having a diameter of at least 0.2 mm.

### Claim 42 (depends on 41)

A prosthetic vascular graft according to claim 41 wherein the tube has been perforated by a laser.

### Claim 43 (depends on 42)

A prosthetic vascular graft according to claim 42 wherein the tubular exterior covering comprises a porous polytetrafluoroethylene tube.

### Claim 44 (depends on 41)

A prosthetic vascular graft according to claim 41 wherein the tubular exterior covering comprises a porous polytetrafluoroethylene tube.

### Claim 45 (depends on 40)

A prosthetic vascular graft according to claim 40 wherein the tubular exterior covering comprises a porous polytetrafluoroethylene tube.

### Claim 46 (depends on 1)

A prosthetic vascular graft according to claim 1 having an exterior covering of porous polytetrafluoroethylene film.

### Claim 47 (depends on 1)

A prosthetic vascular graft according to claim 1 having a tubular exterior covering.

### Claim 48 (depends on 47)

A prosthetic vascular graft according to claim 47 wherein the tubular exterior covering is a tube having a wall thickness and having at least two macroscopic perforations through the wall thickness, said macroscopic perforations having a diameter of at least 0.2 mm.

### Claim 49 (depends on 48)

A prosthetic vascular graft according to claim 48 wherein the tube has been perforated by a laser.

### Claim 50 (depends on 49)

A prosthetic vascular graft according to claim 49 wherein the tubular exterior covering comprises a porous polytetrafluoroethylene tube.

### Claim 51 (depends on 48)

A prosthetic vascular graft according to claim 48 wherein the tubular exterior covering comprises a porous polytetrafluoroethylene tube.

### Claim 52 (depends on 47)

A prosthetic vascular graft according to claim 47 wherein the tubular exterior covering comprises a porous polytetrafluoroethylene tube.

### Claim 53 (depends on 1)

A prosthetic vascular graft according to claim 1 wherein the two different types of fibers are a first fiber comprising porous polytetrafluoroethylene film having an oblong cross section and a second fiber comprising porous polytetrafluoroethylene of substantially round cross section.

### Claim 54 (depends on 53)

A prosthetic vascular graft according to claim 53 having a tubular exterior covering.

### Claim 55 (depends on 54)

A prosthetic vascular graft according to claim 54 wherein the tubular exterior covering is a porous polytetrafluoroethylene tube.

### Claim 56 (depends on 55)

A prosthetic vascular graft according to claim 55 wherein the porous polytetrafluoroethylene tube has a wall thickness and has at least two macroscopic perforations through the wall thickness, said macroscopic perforations having a diameter of at least 0.2 mm.

### Claim 57 (depends on 53)

A prosthetic vascular graft according to claim 53 wherein at least a portion of the base substrate at ambient temperature is capable of being stretched and rapidly recovering more than about 10 percent of its stretched length.

### Claim 58 (depends on 57)

A prosthetic vascular graft according to claim 57 having a tubular exterior covering.

### Claim 59 (depends on 58)

A prosthetic vascular graft according to claim 58 wherein the tube is a porous polytetrafluoroethylene tube.

### Claim 60 (depends on 59)

A prosthetic vascular graft according to claim 59 wherein the porous polytetrafluoroethylene tube has a wall thickness and has at least two macroscopic perforations through the wall thickness, said macroscopic perforations having a diameter of at least 0.2 mm.

### Claim 61

A prosthetic vascular graft comprising a base substrate of biocompatible material having an ablumenal surface wherein a substantial portion of the ablumenal surface is provided with an outer covering of deflectably secured material that is capable of being deflected with respect to the ablumenal surface of the base substrate, wherein said deflectably secured material is comprised of a bioabsorbable material and, wherein the deflectably secured material is secured to the base substrate in such a manner that a substantial portion of the deflectably secured material is not directly secured to the base substrate and a substantial portion of adjacent surfaces of the deflectably secured material are not directly secured to each other wherein said fibers are free to move with respect to each other within a length of the graft.

### Claim 62 (depends on 61)

A prosthetic vascular graft according to claim 61 wherein the bioabsorbable material is bioabsorbable fibers.

### Claim 63 (depends on 61)

A prosthetic vascular graft according to claim 61 wherein the bioabsorbable material is bioabsorbable film.

### Claim 64 (depends on 61)

A prosthetic vascular graft according to claim 61 wherein the bioabsorbable material comprises discrete pieces of bioabsorbable material that are deflectably secured by an exterior wrapping of film.

### Claim 65

A prosthetic vascular graft comprising a base substrate of biocompatible material having an ablumenal surface wherein a substantial portion of the ablumenal surface is provided with an outer covering of deflectably secured material that is capable of being deflected with respect to the ablumenal surface of the base substrate, wherein said deflectably secured material is secured to the base substrate at least one location by thermally bonding the deflectably secured material to the base substrate and, wherein the deflectably secured material is secured to the base substrate in such a manner that a substantial portion of the deflectably secured material is not directly secured to the base substrate and a substantial portion of adjacent surfaces of the deflectably secured material are not directly secured to each other whereins aid fibers are free to move with respect to each other within a length of the graft.

### Claim 66

A prosthetic vascular graft comprising a base substrate of biocompatible material having an ablumenal surface wherein a substantial portion of the ablumenal surface is provided with an outer covering of deflectably secured material that is capable of being deflected with respect to the ablumenal surface of the base substrate, wherein said deflectably secured material is at least two different types of fibers, wherein said deflectably secured material is secured to the base substrate at at least one location by thermally bonding the deflectably secured material to the base substrate and, wherein the deflectably secured material is secured to the base substrate in such a manner that a substantial portion of the deflectably secured material is not directly secured to the base substrate and a substantial portion of adjacent surfaces of the deflectably secured material are not directly secured to each other wherein said fibers are free to move with respect to each other within a length of the graft.
