[go: up one dir, main page]

WO1993002637A1 - Prothese vasculaire - Google Patents

Prothese vasculaire Download PDF

Info

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
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/GB1992/001338
Other languages
English (en)
Inventor
Christopher John Underwood
David Charlesworth
Kerm Sin Chian
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Polymedica Industries Inc
Original Assignee
Polymedica Industries Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Polymedica Industries Inc filed Critical Polymedica Industries Inc
Priority to EP92914375A priority Critical patent/EP0596905A1/fr
Publication of WO1993002637A1 publication Critical patent/WO1993002637A1/fr
Anticipated expiration legal-status Critical
Priority to US08/655,317 priority patent/US5756035A/en
Ceased legal-status Critical Current

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.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Epidemiology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Medicinal Chemistry (AREA)
  • Cardiology (AREA)
  • Dermatology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Thermal Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Prostheses (AREA)

Abstract

Prothèse vasculaire (20) adaptée pour servir de court-circuit artério-veineux possédant une section coudée en U (21) indéformable et résistante à l'entortillement.
PCT/GB1992/001338 1991-08-01 1992-07-21 Prothese vasculaire Ceased WO1993002637A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP92914375A EP0596905A1 (fr) 1991-08-01 1992-07-21 Prothese vasculaire
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 (fr) 1993-02-18

Family

ID=10699303

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB1992/001338 Ceased WO1993002637A1 (fr) 1991-08-01 1992-07-21 Prothese vasculaire

Country Status (4)

Country Link
EP (1) EP0596905A1 (fr)
AU (1) AU2329892A (fr)
GB (1) GB9116563D0 (fr)
WO (1) WO1993002637A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1995009585A1 (fr) * 1993-10-01 1995-04-13 Imperial College Of Science, Technology & Medicine Protheses vasculaires
GB2297263A (en) * 1993-10-01 1996-07-31 Imperial College Vascular prostheses
EP0807425A1 (fr) * 1996-05-16 1997-11-19 CardioTech International Ltd Fabrication d'une greffe d'accès

Citations (10)

* Cited by examiner, † Cited by third party
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 (fr) * 1982-12-13 1984-06-21 Possis Medical Inc Greffe vasculaire et procede d'alimentation en sang
WO1987005796A1 (fr) * 1986-03-27 1987-10-08 Advanced Vascular Technologies, Inc. Protheses vasculaires et procede de fabrication
EP0269449A2 (fr) * 1986-11-26 1988-06-01 BAXTER INTERNATIONAL INC. (a Delaware corporation) Fluoropolymère, poreux et flexible, expansé radialement et son procédé de fabrication
EP0286220A1 (fr) * 1987-04-09 1988-10-12 Newtec Vascular Products Ltd. Procédés et dispositif pour la fabrication d'un matériau en polymère
WO1989001765A1 (fr) * 1987-08-28 1989-03-09 Jarvik Robert K Dispositifs prothetiques servant a retablir l'elasticite arterielle
EP0334567A2 (fr) * 1988-03-21 1989-09-27 Ethicon, Inc. Greffons vasculaires synthétiques
WO1990005628A1 (fr) * 1988-11-22 1990-05-31 Newtec V.P. Limited Structure composite
US4969896A (en) * 1989-02-01 1990-11-13 Interpore International Vascular graft prosthesis and method of making the same

Patent Citations (10)

* Cited by examiner, † Cited by third party
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 (fr) * 1982-12-13 1984-06-21 Possis Medical Inc Greffe vasculaire et procede d'alimentation en sang
WO1987005796A1 (fr) * 1986-03-27 1987-10-08 Advanced Vascular Technologies, Inc. Protheses vasculaires et procede de fabrication
EP0269449A2 (fr) * 1986-11-26 1988-06-01 BAXTER INTERNATIONAL INC. (a Delaware corporation) Fluoropolymère, poreux et flexible, expansé radialement et son procédé de fabrication
EP0286220A1 (fr) * 1987-04-09 1988-10-12 Newtec Vascular Products Ltd. Procédés et dispositif pour la fabrication d'un matériau en polymère
WO1989001765A1 (fr) * 1987-08-28 1989-03-09 Jarvik Robert K Dispositifs prothetiques servant a retablir l'elasticite arterielle
EP0334567A2 (fr) * 1988-03-21 1989-09-27 Ethicon, Inc. Greffons vasculaires synthétiques
WO1990005628A1 (fr) * 1988-11-22 1990-05-31 Newtec V.P. Limited Structure composite
US4969896A (en) * 1989-02-01 1990-11-13 Interpore International Vascular graft prosthesis and method of making the same

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1995009585A1 (fr) * 1993-10-01 1995-04-13 Imperial College Of Science, Technology & Medicine Protheses vasculaires
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 (fr) * 1996-05-16 1997-11-19 CardioTech International Ltd Fabrication d'une greffe d'accès

Also Published As

Publication number Publication date
EP0596905A1 (fr) 1994-05-18
GB9116563D0 (en) 1991-09-18
AU2329892A (en) 1993-03-02

Similar Documents

Publication Publication Date Title
US7727274B2 (en) Porous synthetic vascular grafts with oriented ingrowth channels
EP0130401B1 (fr) Vaisseau artificiel et procédé de sa préparation
CA2685454C (fr) Greffe sertie en ptfe expanse
US7632306B2 (en) Foam-type vascular prosthesis with well-defined angio-permissive open porosity
US4657544A (en) Cardiovascular graft and method of forming same
US4759757A (en) Cardiovascular graft and method of forming same
US4957508A (en) Medical tubes
EP0128501B1 (fr) Vaisseau artificiel et son procédé de préparation
US4173689A (en) Synthetic polymer prosthesis material
US5756035A (en) Method of making an access graft and a vascular prosthesis
WO1993002637A1 (fr) Prothese vasculaire
US5462704A (en) Method for preparing a porous polyurethane vascular graft prosthesis
EP0495127A1 (fr) Vaisseau sanguin artificiel et procede de production associe
WO1993002636A1 (fr) Prothese vasculaire
JPH0254101B2 (fr)
JPH0261260B2 (fr)
JP2553522B2 (ja) 医療用チユ−ブ及びその製造方法
EP1669044A2 (fr) Prothèse vasculaire de type mousse avec porosité ouverte angio-permissive bien définie
JPH0237184B2 (fr)
JPS63222758A (ja) 医療用チユ−ブ

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): AT AU BB BG BR CA CH CS DE DK ES FI GB HU JP KP KR LK LU MG MN MW NL NO PL RO RU SD SE US

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): AT BE CH DE DK ES FR GB GR IT LU MC NL SE BF BJ CF CG CI CM GA GN ML MR SN TD TG

DFPE Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed before 20040101)
WWE Wipo information: entry into national phase

Ref document number: 1992914375

Country of ref document: EP

ENP Entry into the national phase

Ref country code: US

Ref document number: 1994 182156

Date of ref document: 19940429

Kind code of ref document: A

Format of ref document f/p: F

WWP Wipo information: published in national office

Ref document number: 1992914375

Country of ref document: EP

REG Reference to national code

Ref country code: DE

Ref legal event code: 8642

NENP Non-entry into the national phase

Ref country code: CA

WWR Wipo information: refused in national office

Ref document number: 1992914375

Country of ref document: EP

WWW Wipo information: withdrawn in national office

Ref document number: 1992914375

Country of ref document: EP