WO1999017816A1 - Implant comblant un espace recouvert de ptfe expanse - Google Patents

Implant comblant un espace recouvert de ptfe expanse Download PDF

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Publication number
WO1999017816A1
WO1999017816A1 PCT/US1998/020797 US9820797W WO9917816A1 WO 1999017816 A1 WO1999017816 A1 WO 1999017816A1 US 9820797 W US9820797 W US 9820797W WO 9917816 A1 WO9917816 A1 WO 9917816A1
Authority
WO
WIPO (PCT)
Prior art keywords
space
implant according
elastomeric material
filling implant
filling
Prior art date
Application number
PCT/US1998/020797
Other languages
English (en)
Inventor
Stanislaw L. Zukowski
Original Assignee
Gore Enterprise Holdings, 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 Gore Enterprise Holdings, Inc. filed Critical Gore Enterprise Holdings, Inc.
Priority to AU97834/98A priority Critical patent/AU9783498A/en
Publication of WO1999017816A1 publication Critical patent/WO1999017816A1/fr

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
    • A61L27/28—Materials for coating prostheses
    • A61L27/34—Macromolecular materials

Definitions

  • ePTFE used alone as a space filling implant
  • it is relatively soft and compressible, when compressed, the porous ePTFE does not readily recover but rather remains in a compressed state
  • the softness of the material prevents it from being readily shapeable in that when used in thicknesses greater those of its more conventional sheet forms (e g , thicknesses greater than about 1 mm) it is extremely difficult to cut with a blade for shaping
  • a sharp blade does not readily cut the soft material but rather causes it to indent and compress under the blade edge
  • US Patent 5,098 779 describe ePTFE space-filling implants made carvable by impregnating the void space of the material with a resorbable material which renders the resulting composite adequately rigid for carving Over time immediately following implantation the resorbable material is taken up by the surrounding tissue allowing the tissue to ingrow into the void space of the ePTFE
  • An alternative carvable form of ePTFE for space-filling is described by Sharber et al (W
  • EP 0320170 teaches that ePTFE may be formed into shapes including compound curves such as domes
  • the present invention relates to a space-filling implant and a method of making
  • the implant comprises a substantially solid, three-dimensional shape of elastome ⁇ c material such as silicone, polyurethane or a fluoropolymer elastomer which is provided with a covering of expanded polytetrafluoroethylene over substantially the entire exterior surface of the implant
  • substantially solid is meant that the three-dimensional shape does not contain large void spaces (larger than 1 cm length) which might contain another material such as air, a liquid or a gel, and that the elastome ⁇ c material is substantially solid (more solid than a gel) following curing of the elastomer during manufacture of the implant
  • the elastome ⁇ c material may be porous in that it may contain small void spaces
  • Substantially the entire exterior surface of the implant means that the covering is applied over at least about 75% of the exterior surface area of the shape of elastome ⁇ c material Preferably at least 80%, 85%, 90%, 95%, 98%,
  • the implant may be formed by filling an ePTFE covering with the silicone core material under pressure sufficient to cause the silicone to interpenetrate the void spaces of the ePTFE adjacent to the interior surfaces of the ePTFE covering and finally curing the silicone
  • a preferred method of manufacture is thus to line the interior surfaces of the cavity of a mold or form with the ePTFE covering material, the cavity of the mold or form having the shape of the desired space-filling implant
  • the ePTFE covering material is then filled under pressure with the elastomer which is preferably silicone, the pressure again being adequate to achieve interpenetration of the interior surfaces of the ePTFE with the silicone
  • the silicone is then cured and the implant removed from the mold or form Any extraneous edge material may then be selectively cut away from the desired shape of the implant
  • the result is an ePTFE covered
  • Figure 1 describes a cross section of a space-filling implant of the present invention
  • Figure 2 describes a cross sectional view of a mold having a cavity lined with ePTFE sheet material prior to filling with elastomer
  • Figure 3 describes the mold of Figure 2 after filling with elastomer
  • Figure 4 describes the implant after removal from the mold and prior to trimming excess ePTFE edge material
  • Figure 1 describes a cross section of an implant 10 of the present invention comprising a substantially solid elastomeric core 13 provided with an ePTFE covering 1 1
  • the elastomeric core is preferably a medical grade silicone the fabrication of which is well known in the art It is available in different hardnesses or durometers, allowing the hardness and compliance of the resulting implant to be controlled
  • Other elastomers may also be used when available in adequately pure and biocompatible forms, these may include polyurethanes and fluoroelastomers
  • the ePTFE covering material covers substantially all surfaces of the elastomeric core This material is made as taught by US Patents 3,953,566 and 4,187,390 These patents teach that the pore size and fibril length (or distance between adjacent nodes) can be controlled by varying aspects of the manufacturing process, primarily the stretch rate It is available in a variety of forms commercially and is commonly manufactured as both tubes and sheets It has a history of use as an implantable material (primarily as a vascular graft
  • the unsintered material is softer and more easily deformed, and may therefore be more easily used as a covering material appropriate for irregular shapes of the elastomeric core
  • Figure 2 describes a method of making the space-filling implant of the present invention wherein a mold or form 16 is provided, preferably in two separable halves 18 and 19 Mold 16 has a cavity which is provided with sheets of ePTFE 15 and 17 lining the inner surfaces of the cavity such that the edges of sheets 15 and 17 extend outward through and beyond the edges of the mold halves 18 and 19 where these edges are intended to mate together
  • Optional port tubes 20A and 20B are preferably inserted at opposite ends of the mold halves prior to bringing the ePTEF sheet mold halves together, these are intended to provide access to the mold cavity for the injection of uncured elastomer and to allow the escape of air as indicated by arrows 21 and 23
  • Port tube 20B may be dispensed with by simply allowing air to escape from between the edges of ePTFE sheets 15 and 17 during the process of injecting elastomer into the mold cavity until it is full The injection is done under pressure adequate to cause the elastomer to escape from between the edges of the
  • ePTFE sheets 15 and 17 may be replaced by a tubular ePTFE form which form is preferably unsintered ePTFE
  • the ePTFE tube may be placed into the mold and elastomer may be injected into the lumen of the ePTFE tube under pressure sufficient to fill the tube and cause deformation of the tube appropriate to allow the tube to conform to the shape of the cavity within the mold
  • the elastomer core component 13 may be a commercially available silicone space-filling implant
  • the ePTFE covering material 11 may be a tubular form of unsintered ePTFE which fits snugly over the silicone core 13, the tube being selected to have an inside diameter of about the same dimension of the largest diameter of the silicone core
  • Silicone adhesive is applied to the exterior surfaces of the silicone core which is then inserted into the ePTFE tube
  • Tension is applied to opposing ends of the ePTFE tube thereby causing it to neck down and conform to the exterior of the silicone core 13
  • Heat of less than the crystalline melt temperature of the PTFE may be used during this tensionmg step to better enable deformation of the ePTFE tube necessary for conformation to the surfaces of the silicone core
  • This process may be augmented by the use of a mold in a similar fashion to that described above to ensure conformation of the ePTFE material to the silicone core
  • ePTFE sheet materials may be used to cover the silicone space-filling implant which has been coated with an adhesive
  • thermoplastic sheet materials placed between the elastomer core and the ePTFE covering material
  • Preferred materials include fluo ⁇ nated ethylene propylene (FEP) and perfluonnated alkoxy resin (PFA), heat and pressure are then used to activate these, again preferably with the use of a mold

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne une forme élastomère recouverte de PTFEe servant d'implant comblant un espace destiné à la chirurgie plastique. L'invention concerne également ses procédés de production. Cet implant présente un risque de migration beaucoup plus réduit grâce à son revêtement en PTFEe, le PTFEe présentant une taille des pores appropriée pour permettre une fixation tissulaire et le retrait ultérieur de l'implant sans produire de lésion tissulaire excessive due à une croissance interne et à une fixation excessives des tissus. La taille des pores peut être sélectionnée pour satisfaire ces conditions contraires de croissance interne et d'aptitude au retrait. Différentes surfaces de l'implant peuvent être pourvues de revêtements en PTFEe de porosités différentes selon les différents degrés de fixation que l'on souhaite obtenir sur les différentes surfaces. On peut réguler la dureté totale de l'implant en sélectionnant un matériau élastomère de degré de dureté voulue destiné au coeur de l'implant.
PCT/US1998/020797 1997-10-03 1998-10-02 Implant comblant un espace recouvert de ptfe expanse WO1999017816A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU97834/98A AU9783498A (en) 1997-10-03 1998-10-02 An expanded ptfe covered space-filling implant

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US6090397P 1997-10-03 1997-10-03
US60/060,903 1997-10-03

Publications (1)

Publication Number Publication Date
WO1999017816A1 true WO1999017816A1 (fr) 1999-04-15

Family

ID=22032461

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1998/020797 WO1999017816A1 (fr) 1997-10-03 1998-10-02 Implant comblant un espace recouvert de ptfe expanse

Country Status (2)

Country Link
AU (1) AU9783498A (fr)
WO (1) WO1999017816A1 (fr)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011059823A1 (fr) * 2009-10-29 2011-05-19 Gore Enterprise Holdings, Inc. Bouchon de seringue revêtu de ptfe expansé
US9078630B2 (en) 2001-06-01 2015-07-14 St. Jude Medical, Cardiology Division, Inc. Closure devices, related delivery methods and tools, and related methods of use
US9333070B2 (en) 2008-02-01 2016-05-10 Evera Medical, Inc. Breast implant with internal flow dampening
US9539394B2 (en) 2011-04-15 2017-01-10 W. L. Gore & Associates, Inc. Method of reducing friction between syringe components
US9597458B2 (en) 2009-10-29 2017-03-21 W. L. Gore & Associates, Inc. Fluoropolymer barrier materials for containers
WO2017120608A1 (fr) * 2016-01-08 2017-07-13 Anton Mark A Composite eptfe et implants de tissu mou en silicone pour minimiser la contracture capsulaire, le poids, les infections et la palpabilité
US10471212B2 (en) 2009-10-29 2019-11-12 W. L. Gore & Associates, Inc. Silicone free drug delivery devices
US11612697B2 (en) 2010-10-29 2023-03-28 W. L. Gore & Associates, Inc. Non-fluoropolymer tie layer and fluoropolymer barrier layer

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4820303A (en) * 1984-08-30 1989-04-11 Daniel Brauman Implantable prosthetic devices
EP0322194A1 (fr) * 1987-12-22 1989-06-28 Walter Joseph Ledergerber Dispositif prosthétique implantable
WO1995022359A1 (fr) * 1994-02-17 1995-08-24 W.L. Gore & Associates, Inc. Matiere pour implant en ptfe modelable

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4820303A (en) * 1984-08-30 1989-04-11 Daniel Brauman Implantable prosthetic devices
EP0322194A1 (fr) * 1987-12-22 1989-06-28 Walter Joseph Ledergerber Dispositif prosthétique implantable
WO1995022359A1 (fr) * 1994-02-17 1995-08-24 W.L. Gore & Associates, Inc. Matiere pour implant en ptfe modelable

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9078630B2 (en) 2001-06-01 2015-07-14 St. Jude Medical, Cardiology Division, Inc. Closure devices, related delivery methods and tools, and related methods of use
US9333070B2 (en) 2008-02-01 2016-05-10 Evera Medical, Inc. Breast implant with internal flow dampening
US8722178B2 (en) 2009-10-29 2014-05-13 W. L. Gore & Associates, Inc. Syringe stopper
WO2011059823A1 (fr) * 2009-10-29 2011-05-19 Gore Enterprise Holdings, Inc. Bouchon de seringue revêtu de ptfe expansé
AU2010319826B2 (en) * 2009-10-29 2014-07-24 W. L. Gore & Associates, Inc. Syringe stopper coated with expanded PTFE
JP2013509270A (ja) * 2009-10-29 2013-03-14 ゴア エンタープライズ ホールディングス，インコーポレイティド 延伸ｐｔｆｅで被覆されるシリンジストッパー
CN102725012A (zh) * 2009-10-29 2012-10-10 戈尔企业控股股份有限公司 涂覆膨胀型ptfe的注射器塞
US9597458B2 (en) 2009-10-29 2017-03-21 W. L. Gore & Associates, Inc. Fluoropolymer barrier materials for containers
US10471212B2 (en) 2009-10-29 2019-11-12 W. L. Gore & Associates, Inc. Silicone free drug delivery devices
US10478563B2 (en) 2009-10-29 2019-11-19 W. L. Gore & Associates, Inc. Fluoropolymer barrier materials for containers
US11020531B2 (en) 2009-10-29 2021-06-01 W. L. Gore & Associates, Inc. Silicone free drug delivery devices
US11654241B2 (en) 2009-10-29 2023-05-23 W. L. Gore & Associates, Inc. Fluoropolymer barrier material for containers
US11612697B2 (en) 2010-10-29 2023-03-28 W. L. Gore & Associates, Inc. Non-fluoropolymer tie layer and fluoropolymer barrier layer
US9539394B2 (en) 2011-04-15 2017-01-10 W. L. Gore & Associates, Inc. Method of reducing friction between syringe components
WO2017120608A1 (fr) * 2016-01-08 2017-07-13 Anton Mark A Composite eptfe et implants de tissu mou en silicone pour minimiser la contracture capsulaire, le poids, les infections et la palpabilité

Also Published As

Publication number Publication date
AU9783498A (en) 1999-04-27

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