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WO1991001695A1 - Ameliorations relatives a des greffes vasculaires synthetiques et leurs procedes de fabrication - Google Patents

Ameliorations relatives a des greffes vasculaires synthetiques et leurs procedes de fabrication Download PDF

Info

Publication number
WO1991001695A1
WO1991001695A1 PCT/GB1990/001204 GB9001204W WO9101695A1 WO 1991001695 A1 WO1991001695 A1 WO 1991001695A1 GB 9001204 W GB9001204 W GB 9001204W WO 9101695 A1 WO9101695 A1 WO 9101695A1
Authority
WO
WIPO (PCT)
Prior art keywords
graft
mandrel
plates
plate means
end portions
Prior art date
Application number
PCT/GB1990/001204
Other languages
English (en)
Inventor
David Annis
Original Assignee
Ethicon, Inc.
The University Of Liverpool
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 Ethicon, Inc., The University Of Liverpool filed Critical Ethicon, Inc.
Publication of WO1991001695A1 publication Critical patent/WO1991001695A1/fr

Links

Classifications

    • 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

Definitions

  • the invention relates to synthetic vascular grafts and methods of their manufacture.
  • a microfibrous structure as described in UK-A-2121286 or UK-A-2120946 with filaments of a diameter of the order of 1 ⁇ m to 2 ⁇ m generally randomly oriented allows multiple needling without deterioration, but is somewhat stiff and difficult to bend to a desired configuration during surgery.
  • a fibrous structure having a mixture of smaller diameter fibres (typically I ⁇ m) and larger diameter fibres (typically 10 ⁇ m) with voids in the structure, as described in EP-A-223374A provides good flexibility without kinking, but does not have the same resistance to deterioration when exposed to multiple needling as does the structure described earlier.
  • a composite, continuously electrostatically spun synthetic vascular graft comprising a central graft portion having a first polymeric microfibrous structure of fibres of substantially uniform diameter and end graft portions having a second microfibrous structure including fibres of different diameter, transition between the first and second fibrous structures being sufficiently gradual to avoid sudden flexibility changes in the graft between the central portion and the end portions.
  • the second microfibrous structure preferably includes voids.
  • a meld layer (that is a substantially impervious, non fibrous layer) may be present within the fibrous structure, and preferably extends along the length of the graft.
  • the meld layer is preferably produced by electrostatic spinning of polymeric material under different electrostatic conditions.
  • end portions and possibly the entire graft, may be coated externally with an impervious layer of non-biodegradable material such as silicone rubber.
  • the invention further provides a method of producing a composite electrostatically spun synthetic vascular graft according to the invention comprising the steps of
  • the method may comprise an initial step of creating a field surrounding the mandrel to produce said first fibrous structure along the length of the graft, before altering the end fields to produce said second fibrous structure.
  • the end and centre fields may be altered during graft production to create a substantially impervious melded layer along the length of the graft within the fibrous structure.
  • the method may include a further step of coating at least the end portions of a graft with impervious elastomeric material, for example silicone rubber.
  • the second fibrous structure is less dense than the first fibrous structure, and when the end portions have reached a desired thickness, the centre portion may be too thin. Accordingly, the method preferably provides a further step, when the end portions have reached a desired thickness, of altering the electrostatic field surrounding the mandrel to reduce deposition of fibres at the end portions but allow uninterrupted deposition of fibres at the centre portion.
  • the step of reducing deposition of fibres at the end portions is preferably achieved by charging conducting plates in the region of the end portions such that fibreizable material is attracted to the plates rather than the mandrel.
  • the invention further provides apparatus for electrostatically spinning a graft according to the invention, which apparatus comprises a mandrel, first electrostatically chargeable plate means to create an electrostatic field surrounding regions of the mandrel to collect the end portions of the graft, and second electrostatically chargeable plate means to create an electrostatic field surrounding a central portion of the mandrel.
  • the first plate means may comprise two pairs of parallel plates, the mandrel extending between the plates of each pair, and one pair lying at each end of the mandrel.
  • the second plate means may comprise a pair of parallel plates between which plates a central portion of the mandrel lies.
  • the plates of the second plate means may overlap the plates of the first plate means.
  • the plates of the second plate means may lie closer together than the plates of each pair of the first plate means.
  • the plates may be essentially rectangular, but preferably have rounded corners where the first plate means lie adjacent the second plate means.
  • Figure 1 is a front elevation of apparatus according to the invention
  • Figure 2 is a plan view of the apparatus of Figure 1 ;
  • Figure 3 is a table of voltages and flows
  • Figure 4 is a view of an arm and an arterio-venous fistula graft.
  • Figure 5 is an enlarged sectional view through a graft wall.
  • the apparatus of Figures 1 and 2 comprises a rotatable mandrel 10, the speed of rotation being variable but generally several hundred r.p.m.
  • the mandrel 10 is electrostatically chargeable by known means.
  • the mandrel is journalled in bearings 13 insulated from the remainder of the apparatus.
  • the mandrel 10 Above and below the mandrel 10 are arranged electrostatically chargeable plates, the plates being arranged in pairs to provide two pairs of end plates 11 and a pair of centre plates 12.
  • the centre plates 12 are closer together than the end plates 11, and the plates 11 and 12 are arranged symmetrically about the mandrel 10 when viewed parallel to the plane of the plates, but the mandrel is located towards leading edges of the plates 11 and 12, as shown in the plan view of Figure 2.
  • inventions 1 and 2 The preferred form of apparatus shown in Figures 1 and 2 has end plates of length 320mm spaced 140mm apart, and centre plates 12 of length 112mm spaced 100mm apart.
  • the end plates 11 overlap the centre plates 12 by 9mm each side. It will be appreciated that this embodiment may* be subject to variation in dimensions and proportions.
  • a preferred sequence for using the apparatus of Figures 1 and 2 to produce a graft is as follows, reference being made to the table of Figure 3 in which kVA refers to the potential of the end plates 11 , kVB refers to the potential of the centre plates 12, kVC refers to the potential of the mandrel, Q refers to the flow rate in ml per hour of fibreizable material in solution, and VOL refers to the volume of solution directed at the mandrel in each phase.
  • the potentials in the table of Figure 3 lay down an inner layer of microfibres (diameter typically 1 ⁇ m to 2 ⁇ m) uniformly over the whole length of the mandrel.
  • the potential of the centre plates 12 needs to be lower than that of the end plates as the plates 12 are closer together.
  • the microfibrous structure produced is similar to those described in UK-A-2121286 and UK-A-2120946, and other documents referred to therein.
  • Phase 1 is short lived.
  • Phase 2 the potential of the end plates 11 is increased, as is the flow rate of fibreizable material. This causes a more open fibrous structure to be formed on the mandrel in the regions of influence of the end plates 11 , while the microfibrous structure of Phase 1 continues to build up in the central portion.
  • the more open structure is substantially as described in EP-A-223374A.
  • the mandrel potential is greatly increased, and plate potentials are reduced, as is flow rate of fibreizable material. This causes a meld layer to be formed along the length of the graft since fibreizable material arrives at the mandrel before fibres are properly formed. Meld layer formation is described in EP-A-266035A. Phase 4
  • Phase 4 When Phase 4 is completed, a triple structure is formed, and the less dense outer portions have reached their desired thickness.
  • the centre section, being compact, is too thin, so production is moved to Phase 5, where the -end plates 11 are highly charged to attract almost all end region fibres directly to them instead of the mandrel.
  • the centre plates 12 are maintained in the condition of Phases 1 , 2 and 4 to allow uninterrupted deposition of microfibrous structure in the central region.
  • Transition between the centre section of the graft and the end sections is achieved gradually, in this embodiment over a graft length of 2cm or so. Transition is achieved by overlap of the plates 11 and 12, and by rounding of the plate corners.
  • the method is conveniently computer controlled to provide continuous operation through the phases.
  • Figure 4 shows an arterio-venous fistula graft 20 according to the invention having a dense microfibrous structure 21 in a central portion, having good properties for multiple needling, and less dense end portions 22, 23 to provide flexibility needed during surgery.
  • the flexible end portions 22, 23 may be silicone rubber coated (for example with SILASTIC - Trade Mark) or coated with other protective, flexible material.
  • Figure 5 shows a wall in diagrammatic section.
  • Phase 1 microfibrous structure is shown at 30 (the first microfibrous structure) and the second microfibrous structure of the bulk of the end * portions is shown at 31, transition portions being shown in the portions defined by lines 32.
  • the meld layer is shown at 33.

Landscapes

  • Health & Medical Sciences (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Nonwoven Fabrics (AREA)

Abstract

Une greffe vasculaire synthétique composite filée de manière continue et électrostatique comprend une partie de greffe centrale comprenant une première structure (30) microfibreuse polymère ainsi que des parties de greffe comportant une seconde structure (31) microfibreuse dotée de fibres de diamètres différents, la transition entre les première et seconde structures fibreuses étant suffisamment graduelle pour éviter des changements de flexibilité soudains dans lesdites greffes entre les parties centrales et les parties terminales. Ladite greffe est filée sur un mandrin par création d'un champ électrostatique central permettant de former la première structure fibreuse, et de champs terminaux entourant les parties terminales du mandrin afin de former la seconde structure fibreuse, ainsi que des champs de transition entre les champs centraux et terminaux, afin de créer le changement graduel entre les champs centraux et terminaux.
PCT/GB1990/001204 1989-08-04 1990-08-02 Ameliorations relatives a des greffes vasculaires synthetiques et leurs procedes de fabrication WO1991001695A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB8917916A GB8917916D0 (en) 1989-08-04 1989-08-04 Improvements in synthetic vascular grafts and their methods of manufacture
GB8917916.2 1989-08-04

Publications (1)

Publication Number Publication Date
WO1991001695A1 true WO1991001695A1 (fr) 1991-02-21

Family

ID=10661208

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB1990/001204 WO1991001695A1 (fr) 1989-08-04 1990-08-02 Ameliorations relatives a des greffes vasculaires synthetiques et leurs procedes de fabrication

Country Status (2)

Country Link
GB (1) GB8917916D0 (fr)
WO (1) WO1991001695A1 (fr)

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001015754A1 (fr) * 1999-08-31 2001-03-08 Virginia Commonwealth University Intellectual Property Foundation Muscle artificiel
WO2002034986A2 (fr) 2000-10-26 2002-05-02 Creavis Gesellschaft Für Technologie Und Innovation Mbh Non-tisses constitues de mesotubes et de nanotubes orientes
EP1275757A2 (fr) 2001-07-13 2003-01-15 Transmit Gesellschaft für Technologietransfer mbH Tubes avec diamètres intérieurs à l'échelle nanométrique
US6592623B1 (en) 1999-08-31 2003-07-15 Virginia Commonwealth University Intellectual Property Foundation Engineered muscle
US7105228B2 (en) 2001-04-02 2006-09-12 Transmit Gesellschaft Fuer Technologietransfer Mbh Method for making shaped structures with internally coated cavities
US7615373B2 (en) 1999-02-25 2009-11-10 Virginia Commonwealth University Intellectual Property Foundation Electroprocessed collagen and tissue engineering
US7759082B2 (en) 1999-02-25 2010-07-20 Virginia Commonwealth University Intellectual Property Foundation Electroprocessed fibrin-based matrices and tissues
US8017061B2 (en) 2004-05-28 2011-09-13 Philipps-Universitat Marburg Invention concerning agricultural active substances
US10888409B2 (en) 2010-06-17 2021-01-12 Washington University Biomedical patches with aligned fibers
US11173234B2 (en) 2012-09-21 2021-11-16 Washington University Biomedical patches with spatially arranged fibers
US11224677B2 (en) 2016-05-12 2022-01-18 Acera Surgical, Inc. Tissue substitute materials and methods for tissue repair
US12167853B2 (en) 2021-09-07 2024-12-17 Acera Surgical, Inc. Non-woven graft materials for nerve repair and regeneration
US12201749B2 (en) 2021-07-29 2025-01-21 Acera Surgical, Inc. Combined macro and micro-porous hybrid-scale fiber matrix
US12263269B2 (en) 2021-07-29 2025-04-01 Acera Surgical, Inc. Particle-form hybrid-scale fiber matrix

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2142870A (en) * 1983-07-06 1985-01-30 Ethicon Inc Manufacturing vascular prosthesis by electrostatic spinning
EP0266035A1 (fr) * 1986-09-02 1988-05-04 Ethicon, Inc. Prothèse vasculaire synthétique

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2142870A (en) * 1983-07-06 1985-01-30 Ethicon Inc Manufacturing vascular prosthesis by electrostatic spinning
EP0266035A1 (fr) * 1986-09-02 1988-05-04 Ethicon, Inc. Prothèse vasculaire synthétique

Cited By (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7615373B2 (en) 1999-02-25 2009-11-10 Virginia Commonwealth University Intellectual Property Foundation Electroprocessed collagen and tissue engineering
US7759082B2 (en) 1999-02-25 2010-07-20 Virginia Commonwealth University Intellectual Property Foundation Electroprocessed fibrin-based matrices and tissues
WO2001015754A1 (fr) * 1999-08-31 2001-03-08 Virginia Commonwealth University Intellectual Property Foundation Muscle artificiel
US6592623B1 (en) 1999-08-31 2003-07-15 Virginia Commonwealth University Intellectual Property Foundation Engineered muscle
WO2002034986A2 (fr) 2000-10-26 2002-05-02 Creavis Gesellschaft Für Technologie Und Innovation Mbh Non-tisses constitues de mesotubes et de nanotubes orientes
US7105228B2 (en) 2001-04-02 2006-09-12 Transmit Gesellschaft Fuer Technologietransfer Mbh Method for making shaped structures with internally coated cavities
EP1275757A2 (fr) 2001-07-13 2003-01-15 Transmit Gesellschaft für Technologietransfer mbH Tubes avec diamètres intérieurs à l'échelle nanométrique
US8017061B2 (en) 2004-05-28 2011-09-13 Philipps-Universitat Marburg Invention concerning agricultural active substances
US8431064B2 (en) 2004-05-28 2013-04-30 Phillips-Universitat Marburg Method of using nanoscaled polymer fibers as carriers for agricultural substances
US11096772B1 (en) 2010-06-17 2021-08-24 Washington University Biomedical patches with aligned fibers
US12144716B2 (en) 2010-06-17 2024-11-19 Washington University Biomedical patches with aligned fibers
US11071617B2 (en) 2010-06-17 2021-07-27 Washington University Biomedical patches with aligned fibers
US10888409B2 (en) 2010-06-17 2021-01-12 Washington University Biomedical patches with aligned fibers
US11000358B2 (en) 2010-06-17 2021-05-11 Washington University Biomedical patches with aligned fibers
US11311366B2 (en) 2010-06-17 2022-04-26 Washington University Biomedical patches with aligned fibers
US11471260B2 (en) 2010-06-17 2022-10-18 Washington University Biomedical patches with aligned fibers
US11173234B2 (en) 2012-09-21 2021-11-16 Washington University Biomedical patches with spatially arranged fibers
US11253635B2 (en) 2012-09-21 2022-02-22 Washington University Three dimensional electrospun biomedical patch for facilitating tissue repair
US11596717B2 (en) 2012-09-21 2023-03-07 Washington University Three dimensional electrospun biomedical patch for facilitating tissue repair
US12246114B2 (en) 2012-09-21 2025-03-11 Washington University Biomedical patches with spatially arranged fibers
US12109334B2 (en) 2012-09-21 2024-10-08 Washington University Three dimensional electrospun biomedical patch for facilitating tissue repair
US11224677B2 (en) 2016-05-12 2022-01-18 Acera Surgical, Inc. Tissue substitute materials and methods for tissue repair
US11826487B2 (en) 2016-05-12 2023-11-28 Acera Surgical, Inc. Tissue substitute materials and methods for tissue repair
US12201749B2 (en) 2021-07-29 2025-01-21 Acera Surgical, Inc. Combined macro and micro-porous hybrid-scale fiber matrix
US12263269B2 (en) 2021-07-29 2025-04-01 Acera Surgical, Inc. Particle-form hybrid-scale fiber matrix
US12167853B2 (en) 2021-09-07 2024-12-17 Acera Surgical, Inc. Non-woven graft materials for nerve repair and regeneration

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Publication number Publication date
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