WO1993002637A1 - Vascular prosthesis - Google Patents
Vascular prosthesis Download PDFInfo
- Publication number
- WO1993002637A1 WO1993002637A1 PCT/GB1992/001338 GB9201338W WO9302637A1 WO 1993002637 A1 WO1993002637 A1 WO 1993002637A1 GB 9201338 W GB9201338 W GB 9201338W WO 9302637 A1 WO9302637 A1 WO 9302637A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- prosthesis
- section
- mandrel
- vascular prosthesis
- cross
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/03—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
- B29C48/09—Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
- B29C48/10—Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels flexible, e.g. blown foils
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/03—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
- B29C48/12—Articles with an irregular circumference when viewed in cross-section, e.g. window profiles
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/25—Component parts, details or accessories; Auxiliary operations
- B29C48/88—Thermal treatment of the stream of extruded material, e.g. cooling
- B29C48/919—Thermal treatment of the stream of extruded material, e.g. cooling using a bath, e.g. extruding into an open bath to coagulate or cool the material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/03—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
- B29C48/09—Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/753—Medical equipment; Accessories therefor
- B29L2031/7532—Artificial members, protheses
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/753—Medical equipment; Accessories therefor
- B29L2031/7532—Artificial members, protheses
- B29L2031/7534—Cardiovascular protheses
Definitions
- This invention concerns a vascular prosthesis adapted for use as an access graft, for example, for use in dialysis patients.
- the present invention provides a vascular prosthesis for use as an- access graft which overcomes., to some extent, the problems aforesaid. According to the invention there is provided a vascular prosthesis adapted for use as an access graft which has a permanent set, kink-resistant U-bend section.
- the cross-section of the prosthesis may be circular or it may be non-circular.
- Examples of non- circular cross-sections for prostheses are tricuspid epitrochoid and deltoid.
- the vascular prosthesis may be arranged to be 'self sealing' after multiple needle puncture.
- a method of making a vascular prosthesis which comprises the steps: a) making a length of bio-compatible vascular prosthesis by coagulation casting and not allowing the casting to dry, b) forming a U-bend in the prosthesis without introducing a kink therein, c) drying the prosthesis while so formed.
- a method of making a vascular prosthesis which comprises the steps: a) making a length of bio-compatible vascular prosthesis by coagulation casting and allowing the casting to dry, then re-wetting the casting. b) forming a U-bend in the prosthesis without introducing a kink therein, c) drying the prosthesis while so formed.
- the prosthesis may be made of a heat degradable polymer and then drying is effected at a temperature which will not degrade the polymer. However, drying may clearly be carried out at temperatures up to 40°C (blood heat) as polymers which will degrade at such temperatures are obviously unsuitable for implantation.
- a solution of coagulatable polymer may be dissolved in an organic solvent and may be coagulation cast onto a mandrel to make the prosthesis.
- the mandrel may have a circular cross-section, or a non-circular cross-section.
- non- circular cross-sections are tricuspid epitrochoid and deltoid.
- the mandrel may be a pre-formed tube of PTFE.
- the mandrel may be dip coated in the polymer solution.
- the polymer solution may, however, be extruded through an extrusion head onto the mandrel to more easily provide a prosthesis of uniform wall thickness.
- the polymer solution may contain a pore-forming agent soluble in a coagulant to leave a porous cast.
- the polymer may comprise polyurethane, and may be a linear segmented poly(ether)urethane with a number average molecular weight in the region 20,000 to 60,000.
- the solvent may be aprotic, and may comprise N,N-Dimethylacetamide or N,N-Dimethylformamide.
- the concentration of the polymer in the solution may be between 10 and 30 grams/decilitre.
- the coagulant may comprise water.
- Figure 1 shows a. top view of the prosthesis of the invention
- Figure 2 shows the cross-section of three types of the prosthesis shown in Figure 1;
- Figure 3 shows the cross-section of three types of mandrels to produce the prosthese ' s of Figure 2.
- Figure 1 shows a vascular prosthesis 20 adapted for use as an access graft having a permanent set, kink-resistant U-bend section 21.
- the cross-sectional shape of the prosthesis 20 is not limited.
- Figure 2 shows three cross-sections of the prosthesis 20, a circular cross-section (a); a tricuspid epitrochoid cross-section (b) and a deltoid cross-section (c). It may be arranged for the prosthesis 20 to have a non-circular cross-section, whereof the lumen 22 will not totally occlude, thus further increasing the kink-resistance of prosthesis 20,
- the prosthesis 20 is made from a bio-compatible material, such as an elastomer, or a combination of elastomer and polytetrafluoroethylene (PTFE).
- a bio-compatible material such as an elastomer, or a combination of elastomer and polytetrafluoroethylene (PTFE).
- Preferred elastomers include polyurethane, polyurethaneurea, segmented polyurethanes and segmented polyurethaneureas. These materials give the prosthesis 20 the property of tending to be 'self-sealing' after needle_puncture, even after multiple needle puncture.
- the prosthesis 20 has a wall thickness and lumen size capable of withstanding multiple needle puncture by a large bore, i.e., 15 gauge needle used for dialysis treatment, while maintaining a compliance similar to that of natural vessels, overcoming the problem which at present prevents such thicker walled, small diameter conventional prostheses being used as access grafts.
- the prosthesis 20, having a permanent set, kink-resistant U-bend 21 is made from a length of vascular prosthesis by coagulation casting a solution of coagulatable heat degradable polymer dissolved in an organic solvent onto a mandrel. Before allowing the casting to dry, or after re-wetting the casting after drying, a U-bend is formed in the prosthesis without introducing any kink therein, and the prosthesis so formed is dried.
- the prosthesis 20 is dried in an oven at a temperature which will not degrade the polymer, usually up to 40°C
- the U-bend 21 is formed in the length of prosthesis, after the introduction of an internal flexible former to prevent collapse of the lumen of the prosthesis on bending, either by drying over a shaped former, or by simply bending the length of prosthesis, having locating means to maintain the U-bend in position until dried. Once dried the internal flexible former is removed.
- a solution of coagulatable polymer such as a linear segmented polyetherurethane with a number average weight of 20,000 to 60,000, is dissolved in a solution comprising an organic solvent, such as N,N-Dimethyl- acetamide or N,N-Dimethylformamide, at a concentration of polymer in the solution of between 10 and 30 grams/ decilitre.
- an organic solvent such as N,N-Dimethyl- acetamide or N,N-Dimethylformamide
- the polymer solution contains a pore-forming agent, soluble in a coagulant to leave a porous cast, such as sodium hydrogen carbonate ground to an average particle size of 60 microns in an amount between 10 and 60 percent by weight.
- a pore-forming agent such as sodium hydrogen carbonate ground to an average particle size of 60 microns in an amount between 10 and 60 percent by weight.
- the polymer solution also contains a surfactant, such as sodium dodecyl sulphate, in an amount between 1 and 10 percent by weight.
- a surfactant such as sodium dodecyl sulphate
- a length of prosthesis- is produced either by dip coating a mandrel in the polymer solution, or, to more easily produce a prosthesis having a uniform wall thickness, by extruding the polymer solution through an extrusion head as described in GB-A-2,204,873.
- the polymer-coated mandrel is then immersed iri a coagulant and allowed to coagulate.
- the preferred coagulant is water which is maintained at a constant temperature throughout the coagulation process, usually 40°C.
- the coagulation process normally takes 1 to 2 hours.
Abstract
Description
Claims
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP92914375A EP0596905A1 (en) | 1991-08-01 | 1992-07-21 | Vascular prosthesis |
US08/655,317 US5756035A (en) | 1991-08-01 | 1996-05-24 | Method of making an access graft and a vascular prosthesis |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB919116563A GB9116563D0 (en) | 1991-08-01 | 1991-08-01 | Vascular prosthesis ii |
GB9116563.9 | 1991-08-01 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1993002637A1 true WO1993002637A1 (en) | 1993-02-18 |
Family
ID=10699303
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/GB1992/001338 WO1993002637A1 (en) | 1991-08-01 | 1992-07-21 | Vascular prosthesis |
Country Status (4)
Country | Link |
---|---|
EP (1) | EP0596905A1 (en) |
AU (1) | AU2329892A (en) |
GB (1) | GB9116563D0 (en) |
WO (1) | WO1993002637A1 (en) |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1995009585A1 (en) * | 1993-10-01 | 1995-04-13 | Imperial College Of Science, Technology & Medicine | Vascular prostheses |
GB2297263A (en) * | 1993-10-01 | 1996-07-31 | Imperial College | Vascular prostheses |
EP0807425A1 (en) * | 1996-05-16 | 1997-11-19 | CardioTech International Ltd | Making an access graft |
Citations (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3882862A (en) * | 1974-01-11 | 1975-05-13 | Olga Berend | Arteriovenous shunt |
FR2248015A1 (en) * | 1973-10-17 | 1975-05-16 | Rhone Poulenc Ind | Artificial ureter or urethra - watertight flexible tube has helical rib in outside wall to prevent creasing |
WO1984002266A1 (en) * | 1982-12-13 | 1984-06-21 | Possis Medical Inc | Vascular graft and blood supply method |
WO1987005796A1 (en) * | 1986-03-27 | 1987-10-08 | Advanced Vascular Technologies, Inc. | Vascular prostheses apparatus and method of manufacture |
EP0269449A2 (en) * | 1986-11-26 | 1988-06-01 | BAXTER INTERNATIONAL INC. (a Delaware corporation) | Porous flexible radially expanded fluoropolymers and process for producing the same |
EP0286220A1 (en) * | 1987-04-09 | 1988-10-12 | Newtec Vascular Products Ltd. | Methods and apparatus for making polymer material |
WO1989001765A1 (en) * | 1987-08-28 | 1989-03-09 | Jarvik Robert K | Prosthetic compliance devices |
EP0334567A2 (en) * | 1988-03-21 | 1989-09-27 | Ethicon, Inc. | Improvements in synthetic vascular grafts |
WO1990005628A1 (en) * | 1988-11-22 | 1990-05-31 | Newtec V.P. Limited | Composite structure |
US4969896A (en) * | 1989-02-01 | 1990-11-13 | Interpore International | Vascular graft prosthesis and method of making the same |
-
1991
- 1991-08-01 GB GB919116563A patent/GB9116563D0/en active Pending
-
1992
- 1992-07-21 EP EP92914375A patent/EP0596905A1/en not_active Ceased
- 1992-07-21 AU AU23298/92A patent/AU2329892A/en not_active Abandoned
- 1992-07-21 WO PCT/GB1992/001338 patent/WO1993002637A1/en not_active Application Discontinuation
Patent Citations (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR2248015A1 (en) * | 1973-10-17 | 1975-05-16 | Rhone Poulenc Ind | Artificial ureter or urethra - watertight flexible tube has helical rib in outside wall to prevent creasing |
US3882862A (en) * | 1974-01-11 | 1975-05-13 | Olga Berend | Arteriovenous shunt |
WO1984002266A1 (en) * | 1982-12-13 | 1984-06-21 | Possis Medical Inc | Vascular graft and blood supply method |
WO1987005796A1 (en) * | 1986-03-27 | 1987-10-08 | Advanced Vascular Technologies, Inc. | Vascular prostheses apparatus and method of manufacture |
EP0269449A2 (en) * | 1986-11-26 | 1988-06-01 | BAXTER INTERNATIONAL INC. (a Delaware corporation) | Porous flexible radially expanded fluoropolymers and process for producing the same |
EP0286220A1 (en) * | 1987-04-09 | 1988-10-12 | Newtec Vascular Products Ltd. | Methods and apparatus for making polymer material |
WO1989001765A1 (en) * | 1987-08-28 | 1989-03-09 | Jarvik Robert K | Prosthetic compliance devices |
EP0334567A2 (en) * | 1988-03-21 | 1989-09-27 | Ethicon, Inc. | Improvements in synthetic vascular grafts |
WO1990005628A1 (en) * | 1988-11-22 | 1990-05-31 | Newtec V.P. Limited | Composite structure |
US4969896A (en) * | 1989-02-01 | 1990-11-13 | Interpore International | Vascular graft prosthesis and method of making the same |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1995009585A1 (en) * | 1993-10-01 | 1995-04-13 | Imperial College Of Science, Technology & Medicine | Vascular prostheses |
GB2297263A (en) * | 1993-10-01 | 1996-07-31 | Imperial College | Vascular prostheses |
GB2297263B (en) * | 1993-10-01 | 1998-04-01 | Imperial College | Vascular prostheses |
US6039754A (en) * | 1993-10-01 | 2000-03-21 | Imperial College Of Science Technology & Medicine | Vascular prostheses |
EP0807425A1 (en) * | 1996-05-16 | 1997-11-19 | CardioTech International Ltd | Making an access graft |
Also Published As
Publication number | Publication date |
---|---|
AU2329892A (en) | 1993-03-02 |
EP0596905A1 (en) | 1994-05-18 |
GB9116563D0 (en) | 1991-09-18 |
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