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WO1993002636A1 - Prothese vasculaire - Google Patents

Prothese vasculaire Download PDF

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Publication number
WO1993002636A1
WO1993002636A1 PCT/GB1992/001337 GB9201337W WO9302636A1 WO 1993002636 A1 WO1993002636 A1 WO 1993002636A1 GB 9201337 W GB9201337 W GB 9201337W WO 9302636 A1 WO9302636 A1 WO 9302636A1
Authority
WO
WIPO (PCT)
Prior art keywords
cross
vascular prosthesis
section
mandrel
solution
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/GB1992/001337
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 EP92915671A priority Critical patent/EP0596926A1/fr
Publication of WO1993002636A1 publication Critical patent/WO1993002636A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • B29C41/00—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor
    • B29C41/02—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor for making articles of definite length, i.e. discrete articles
    • 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
    • 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
    • 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
    • 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
    • B29C67/00—Shaping techniques not covered by groups B29C39/00 - B29C65/00, B29C70/00 or B29C73/00
    • B29C67/02—Moulding by agglomerating
    • B29C67/06—Coagulating
    • 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
    • B29C39/00—Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor
    • 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
    • B29C41/00—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor
    • B29C41/02—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor for making articles of definite length, i.e. discrete articles
    • B29C41/08—Coating a former, core or other substrate by spraying or fluidisation, e.g. spraying powder
    • B29C41/085—Coating a former, core or other substrate by spraying or fluidisation, e.g. spraying powder by rotating the former around its axis of symmetry
    • 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
    • B29C41/00—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor
    • B29C41/02—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor for making articles of definite length, i.e. discrete articles
    • B29C41/14—Dipping a core
    • 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
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2075/00—Use of PU, i.e. polyureas or polyurethanes or derivatives thereof, as moulding material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2105/00—Condition, form or state of moulded material or of the material to be shaped
    • B29K2105/0058—Liquid or visquous
    • B29K2105/0073—Solution
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2995/00—Properties of moulding materials, reinforcements, fillers, preformed parts or moulds
    • B29K2995/0037—Other properties
    • B29K2995/0056—Biocompatible, e.g. biopolymers or bioelastomers
    • 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.
  • Vascular prostheses accomodate pulsatile flow by transiently increasing in cross-sectional area under arterial pressure and this is achieved by uniform extension of the circular prosthesis wall.
  • the measure of the ability of the material of the vessel wall to permit this extension under pressure is the compliance of the artificial vessel.
  • the formation of perigraft fibrosis following implantation will considerably reduce compliance by imparing the ability of the material of the vessel wall to extend under pressure or by resisting radial extension.
  • vascular prostheses which overcome, to some extent, the problems aforesaid.
  • a vascular prosthesis comprising a flexible tube which accomodates pulsatile flow by increasing its cross- sectional area by deformation of the cross-sectional shape.
  • the prosthesis may have a non-circular cross- section when unpressurised or under diastolic pressure.
  • the non-circular cross-section may have rotational symmetry.
  • the cross-sectional shape of the prosthesis may be a tricuspid epitrochoid.
  • the cross-sectional area of the prosthesis may be a deltoid.
  • the lumen of the vascular prosthesis may be designed so that it can never totally occlude and may thereby be kink resistant (By "never” is meant, of course, under the most extreme conditions it will normally encounter - any tube may ultimately be squashed flat by a large enough force) .
  • the vascular prosthesis may comprise a bio- compatible material, which may be an elastomer, such as a segmented polyurethaneurea.
  • a method of making a vascular prosthesis by coagulation casting onto a profiled mandrel a solution of coagulatable polymer dissolved in a solution comprising an organic solvent.
  • the polymer solution may contain a pore-forming agent, such as sodium hydrogen carbonate, soluble in a coagulant for the solution to leave a porous cast.
  • a pore-forming agent such as sodium hydrogen carbonate
  • the pore-forming agent may be ground to an average particle size of 60 microns, and may be present in an amount between 10 and 60 percent by weight.
  • the polymer solution may contain a surfactant, which may be present in an amount between 1 and 10 percent by weight.
  • the polymer may comprise polyurethane, which 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 polymer in the solution may be between 10 and 30 grams/decilitre.
  • the mandrel may have a tricuspid epitrochoid or a deltoid cross-section.
  • the mandrel may be dip coated in the polymer solution but in a preferred method of production, the polymer solution is extruded through an extrusion head onto the mandrel to provide a prosthesis of uniform wall thickness.
  • Figure 1 shows a cross-section through a first embodiment of the invention
  • Figure 2 shows a cross-section of a second embodiment of the invention
  • Figure 3 shows cross-sections of the mandrels used to produce the prostheses of Figures 1 and 2.
  • Figures 1 and 2 illustrate, in cross-section, vascular prostheses comprising flexible tubes which accomodate pulsatile flow by increasing their cross-sectional area by deformation of their cross-sectional shape. In both cases, the prostheses have non-circular cross-sections as illustrated when unpressurised or under diastolic pressure.
  • Figure 1 illustrates a tricuspid epitrochoid cross-section
  • Figure 2 illustrates a deltoid cross-section.
  • Both vascular prostheses have an increased cross-sectional area over conventional vascular prostheses having circular cross sections, as demonstrated in the following Tables.
  • Table 1 shows the percentage gains in cross-sectional area of the vascular prostheses of Figure 1 as the epitrochoid shape becomes more exaggerated, ie. as the arc angle ⁇ 21 decreases.
  • the increase in cross-sectional area is calculated on the basis of the difference between the cross-sectional areas of an epitrochoid and a circle whose perimeter and circumference, respectively, are equal.
  • the increase in cross-sectional area is calculated on the basis of the difference between the cross-sectional areas of a deltoid and a circle whose perimeter and circumference, respectively, are equal.
  • these nori-circular prostheses are extremely kink-resistant because, however much bent z the lumen 24 of these prostheses will never totally occlude.
  • the property of increased volume compliance of these non-circular prostheses relies primarily upon bending of the vessel wall as well as stretching it, ie. on flexural rigidity in addition to elasticity.
  • the prosthesis 20 is made from a flexible material which is capable of bending or stretching under normal blood pressures and is suitable for long term implantation, ie, is bio-compatible.
  • examples of such materials include elastomers, polytetrafluoroethylene (PTFE) or a combination of elastomer and PTFE.
  • Preferred elastomers include polyurethane, polyurethaneurea, segmented polyurethanes and segmented polyurethaneureas. These materials give the prosthesis 20 the property of tending to be r self-sealing' after needle puncture, even after multiple needle puncture.
  • a solution of coagulatable polymer such as a linear segmented polyetherurethane with a number average molecular 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 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 in 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.
  • Mandrel is not limited in its cross-section.
  • Figure 3 shows two examples of mandrels.
  • Mandrel 25 has a tricuspid epitrochoid cross-section and is used to produce the prosthesis of Figure 1.
  • Mandrel 26 has a deltoid cross-section and is used to produce the prosthesis of Figure 2. It will be appreciated that it is not intended to limit the invention to the above example only, many variations, such as might readily occur to one skilled in the art, being possible, without departing from the scope thereof as defined by the appended claims.

Landscapes

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

Abstract

Prothèse vasculaire (20) comportant un tube souple apte à recevoir un débit pulsatile grâce à une augmentation de sa superficie en section par la déformation de sa forme en section.
PCT/GB1992/001337 1991-08-01 1992-07-21 Prothese vasculaire Ceased WO1993002636A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP92915671A EP0596926A1 (fr) 1991-08-01 1992-07-21 Prothese vasculaire

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB9116564.7 1991-08-01
GB919116564A GB9116564D0 (en) 1991-08-01 1991-08-01 Vascular prosthesis i

Publications (1)

Publication Number Publication Date
WO1993002636A1 true WO1993002636A1 (fr) 1993-02-18

Family

ID=10699304

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB1992/001337 Ceased WO1993002636A1 (fr) 1991-08-01 1992-07-21 Prothese vasculaire

Country Status (4)

Country Link
EP (1) EP0596926A1 (fr)
AU (1) AU2329792A (fr)
GB (1) GB9116564D0 (fr)
WO (1) WO1993002636A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5758752A (en) * 1997-03-07 1998-06-02 Samsonite Corporation Automatically extendable and retractable wheel assembly for luggage

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2130521A (en) * 1982-09-15 1984-06-06 Univ Manchester A synthetic tubular structure
WO1989001765A1 (fr) * 1987-08-28 1989-03-09 Jarvik Robert K Dispositifs prothetiques servant a retablir l'elasticite arterielle
WO1990005628A1 (fr) * 1988-11-22 1990-05-31 Newtec V.P. Limited Structure composite

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2130521A (en) * 1982-09-15 1984-06-06 Univ Manchester A synthetic tubular structure
WO1989001765A1 (fr) * 1987-08-28 1989-03-09 Jarvik Robert K Dispositifs prothetiques servant a retablir l'elasticite arterielle
WO1990005628A1 (fr) * 1988-11-22 1990-05-31 Newtec V.P. Limited Structure composite

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5758752A (en) * 1997-03-07 1998-06-02 Samsonite Corporation Automatically extendable and retractable wheel assembly for luggage

Also Published As

Publication number Publication date
EP0596926A1 (fr) 1994-05-18
GB9116564D0 (en) 1991-09-18
AU2329792A (en) 1993-03-02

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