WO1996003165A1 - Prothese de paroi abdominale - Google Patents

Prothese de paroi abdominale Download PDF

Info

Publication number
WO1996003165A1
WO1996003165A1 PCT/GB1995/001715 GB9501715W WO9603165A1 WO 1996003165 A1 WO1996003165 A1 WO 1996003165A1 GB 9501715 W GB9501715 W GB 9501715W WO 9603165 A1 WO9603165 A1 WO 9603165A1
Authority
WO
WIPO (PCT)
Prior art keywords
prosthesis
antimicrobial agent
retaining
resorbable
gel
Prior art date
Application number
PCT/GB1995/001715
Other languages
English (en)
Inventor
Roshan Maini
Timothy Rawden Ashton
Original Assignee
Vascutek Limited
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 Vascutek Limited filed Critical Vascutek Limited
Priority to AU29872/95A priority Critical patent/AU2987295A/en
Priority to EP95925930A priority patent/EP0772468A1/fr
Priority to JP8505567A priority patent/JPH10503099A/ja
Publication of WO1996003165A1 publication Critical patent/WO1996003165A1/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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • 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
    • A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents

Definitions

  • This invention relates to prosthetic material for the repair of the abdominal wall in the case of injury or lesion caused, for example, by hernia, invasive infection or trauma.
  • the invention also encompasses prostheses made from such material.
  • the invention addresses the general problem of providing prosthetic material for abdominal wall reconstruction.
  • PTFE polytetrafluoroethylene
  • GORE-TEX soft tissue patch and macroporous polypropylene mesh (particularly as sold as MARLEX ) have been used as prosthetic materials for abdominal wall reconstruction.
  • Brown et al . (Ann. Surgery 201(6) 705-711 (1985)) experimentally compared PTFE and polypropylene mesh abdominal wall prostheses and found a slight preference for the PTFE material.
  • Antibiotics were administered systemically in these experiments. In spite of the prior work that has been carried out in this area, there remains a low but significant rate of infection associated with synthetic tissue patches for abdominal wall reconstruction.
  • an abdominal wall prosthesis which is capable of retaining and delivering, an antimicrobial agent.
  • the prosthesis may comprise a composite structure of a resorbable porous material which absorbs and retains the microbiological agent.
  • the composite may further comprise a non-resorbable mesh capable for use in abdominal wall reconstruction.
  • Goeau-Brissonniere et al. (Ann. Vaac. Surgery 5(5) 408- 412 (1991) ) used protein-impregnated porous materials containing rifampin as a vascular graft. In that case, the purpose of the protein-impregnation was to completely seal the graft, rather than specifically to provide a matrix for the rifampin. Graft sealing is not a requirement of abdominal wall prostheses, so the prior publication of Goeau-Brissonniere et al. does little to address the problem addressed by the present invention.
  • the porous material of this invention preferably comprises a substrate which is impregnated or otherwise associated with a suitable substance capable of retaining the antimicrobial agent.
  • the substance capable of retaining an antimicrobial agent will not be a separate foil or film. Instead, the substance capable of retaining an antimicrobial agent impregnates the interstices of the substrate to form a composite prosthetic structure.
  • the substance capable of retaining an antimicrobial agent will be completely resorbable in nature and the substrate will be either of synthetic or natural origin and will be non- resorbable once implanted into the patient.
  • the substrate itself may be macroporous or microporous membrane, mesh or fabric. If a fabric, the fabric may be non-woven, woven, or preferably knitted.
  • the fibre from which the fabric is prepared may be polymeric, for example PTFE, polypropylene or polyester, particularly polyethyleneterephthalate (PET) .
  • the substance capable of retaining the antimicrobial agent may be a gel or have a gel-like or sponge-like open structure.
  • the substance is proteinaceous.
  • the protein may be any suitable material having the desired properties for its intended use.
  • the protein is gelatin (which is within the meaning of the term "protein” as it is used in this specification) , ideally partially cross-linked as described in EP-A- 0183365.
  • the protein may also be a polyglycollic acid gel or other synthetic absorbable gel.
  • a suitable and highly desirable protein-impregnated porous material is available from Vascutek Limited under the trade mark GELSEAL.
  • the resorbable gelatin and the membrane mesh or fabric substrate be of a composite construction.
  • Figures 1 and 2 the advantage of using a composite construction is clearly demonstrated. Specifically, in Figure 1, a non-composite, non-impregnated abdominal wall prothesis is shown. As demonstrated the antibiotic is forced to diffuse a great distance in order to surround and protect the mesh. During this diffusion process, antibiotic is lost and therefore lower concentrations of the antimicrobial agents is present at the site of prosthesis insertion. In the composite structure as shown in Figure 2, the antibiotic completely surrounds, the membrane, mesh or fabric due to the interlocking (impregnated) nature of the resorbable gelatin and the non-resorbable membrane, mesh or fabric. This allows the gelatin to completely envelope the substrate and dispense a high antimicrobial concentration around and into the mesh.
  • the antimicrobial agent of this invention may be an antiviral, an antibacterial, an antifungal or an antiprotozoal.
  • Antibacterials include natural and semi- synthetic antibiotics as well as wholly synthetic antibacterials.
  • Rifampin is an antibacterial which may be used to advantage in the present invention. Mixtures of different antimicrobial agents may be used. Sufficient antimicrobial agent will be present to provide an antimicrobial-effective dose of the agent in the conditions of use.
  • the porous material contains the antimicrobial agent.
  • the antimicrobial agent may be absorbed in or adsorbed on the substrate, or even chemically bound to it in some convenient way, providing that its efficacy is not impaired.
  • Prostheses in accordance with the invention may be prepared by the following process, which itself forms part of the invention.
  • a process for the preparation of a prosthesis as described above comprising loading the porous material with antimicrobial agent.
  • the anti ⁇ microbial agent may be supplied in liquid form; if a solid at room temperature, it may be provided in the form of a solution, for example in water or normal saline. In such a case, loading will conveniently be achieved by contacting the porous material with the antimicrobial agent in liquid form, for example by spraying or, preferably, immersion.
  • the gelatin-sealed knitted polyester graft available under the trade mark GE SOFT from Vascutek Limited may be soaked just before use in a lmg/ml normal saline solution of rifampin at 37°C for 15 minutes. This is not to suggest that these conditions are limiting, but rather they are illustrative of the concentration and conditions that may be used to achieve a suitable loading.
  • the porous material itself may be prepared in any suitable way, for example as indicated in EP-A-0183365.
  • prostheses in accordance with the invention is to reconstruct the abdominal wall of humans or, if required, other animals.
  • the invention is therefore expected to be useful in a method of reconstructing the abdominal wall, the method comprising suturing or otherwise connecting a prostheses as described above to the abdominal wall margin.
  • an antimicrobial agent in the preparation of a prosthesis for the abdominal wall.
  • Prosthesis material which may be porous, will generally also be used in the preparation.
  • Gelatin-sealed knitted polyester graft patches were prepared in accordance with EP-A-0183365 and were soaked in a lmg/ml normal saline solution of rifampin (RIFADINE ) at 37°C for 15 minutes.
  • RFADINE rifampin
  • Circular patches 2 cm in diameter containing Rifampicin are implanted subcutaneously in rabbits.
  • the patches were either gelatin impregnated mesh (Gel+) or mesh only

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)

Abstract

Afin de réduire le risque d'infection dans la reconstruction de la paroi abdominale endommagée à la suite d'une hernie ou d'une autre blessure, une prothèse comprend un matériau poreux contenant un agent antibactérien et/ou un autre agent antimicrobien. De préférence, le matériau poreux comprend un substrat sous forme d'une membrane, d'un maillage ou d'une étoffe, en polyester tricoté non résorbable, imprégné d'une gélatine partiellement réticulée (résorbable) ou recouvert de celle-ci, auquel on peut incorporer par mouillage un agent antimicrobien avant de suturer ledit matériau avec le bord de la paroi abdominale.
PCT/GB1995/001715 1994-07-21 1995-07-20 Prothese de paroi abdominale WO1996003165A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
AU29872/95A AU2987295A (en) 1994-07-21 1995-07-20 Prostheses for the abdominal wall
EP95925930A EP0772468A1 (fr) 1994-07-21 1995-07-20 Prothese de paroi abdominale
JP8505567A JPH10503099A (ja) 1994-07-21 1995-07-20 腹壁のための人工器官

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB9414746.9 1994-07-21
GB9414746A GB9414746D0 (en) 1994-07-21 1994-07-21 Prosthetic material

Publications (1)

Publication Number Publication Date
WO1996003165A1 true WO1996003165A1 (fr) 1996-02-08

Family

ID=10758690

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB1995/001715 WO1996003165A1 (fr) 1994-07-21 1995-07-20 Prothese de paroi abdominale

Country Status (5)

Country Link
EP (1) EP0772468A1 (fr)
JP (1) JPH10503099A (fr)
AU (1) AU2987295A (fr)
GB (1) GB9414746D0 (fr)
WO (1) WO1996003165A1 (fr)

Cited By (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19613730A1 (de) * 1996-03-26 1997-10-02 Ethicon Gmbh Flächiges Implantat
US6113641A (en) * 1997-08-27 2000-09-05 Ethicon, Inc. Prosthesis for the obturation of a hernial canal
US6180848B1 (en) 1997-08-27 2001-01-30 Ethicon, Inc. Prosthesis obturating device for the obturation of a hernial canal
US6241768B1 (en) 1997-08-27 2001-06-05 Ethicon, Inc. Prosthetic device for the repair of a hernia
FR2840801A1 (fr) * 2002-06-18 2003-12-19 Cie De Rech En Composants Impl Implant prothetique composite
WO2005051448A1 (fr) * 2003-11-26 2005-06-09 Ethicon Gmbh Implant chirurgical
FR2865379A1 (fr) * 2005-03-02 2005-07-29 Cie De Rech En Composants Impl Implant prothetique composite
WO2006032497A1 (fr) 2004-09-24 2006-03-30 Aesculap Ag & Co. Kg Implant antimicrobien comprenant une structure poreuse souple
US8147478B2 (en) 2000-09-07 2012-04-03 Ams Research Corporation Coated sling material
RU2465654C1 (ru) * 2011-07-27 2012-10-27 Николай Александрович Пострелов Способ моделирования условий протезирующей герниопластики брюшной стенки
US8317808B2 (en) 2008-02-18 2012-11-27 Covidien Lp Device and method for rolling and inserting a prosthetic patch into a body cavity
US8753359B2 (en) 2008-02-18 2014-06-17 Covidien Lp Device and method for deploying and attaching an implant to a biological tissue
US8758373B2 (en) 2008-02-18 2014-06-24 Covidien Lp Means and method for reversibly connecting a patch to a patch deployment device
US8808314B2 (en) 2008-02-18 2014-08-19 Covidien Lp Device and method for deploying and attaching an implant to a biological tissue
US8888811B2 (en) 2008-10-20 2014-11-18 Covidien Lp Device and method for attaching an implant to biological tissue
US8906045B2 (en) 2009-08-17 2014-12-09 Covidien Lp Articulating patch deployment device and method of use
US9034002B2 (en) 2008-02-18 2015-05-19 Covidien Lp Lock bar spring and clip for implant deployment device
US9044235B2 (en) 2008-02-18 2015-06-02 Covidien Lp Magnetic clip for implant deployment device
US9301826B2 (en) 2008-02-18 2016-04-05 Covidien Lp Lock bar spring and clip for implant deployment device
US9393002B2 (en) 2008-02-18 2016-07-19 Covidien Lp Clip for implant deployment device
US9393093B2 (en) 2008-02-18 2016-07-19 Covidien Lp Clip for implant deployment device
US9398944B2 (en) 2008-02-18 2016-07-26 Covidien Lp Lock bar spring and clip for implant deployment device
US9833240B2 (en) 2008-02-18 2017-12-05 Covidien Lp Lock bar spring and clip for implant deployment device
US9999424B2 (en) 2009-08-17 2018-06-19 Covidien Lp Means and method for reversibly connecting an implant to a deployment device

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2846549B1 (fr) * 2002-11-04 2005-08-05 Sofradim Production Prothese de renfort de structures tissulaires
DE102004051487A1 (de) * 2004-10-21 2006-04-27 Ethicon Gmbh Chirurgisches Implantat

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0183365A2 (fr) * 1984-11-30 1986-06-04 Vascutek Limited Greffe vasculaire

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0183365A2 (fr) * 1984-11-30 1986-06-04 Vascutek Limited Greffe vasculaire

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
A. FREYRIE ET AL.: "INTERACTION BETWEEN VASCULAR PROSTHESES AND RIFAMPICIN IN THE PREVENTION OF THE GRAFTS INFECTION. AN EXPERIMENTAL STUDY.", INTERNATIONAL ANGIOLOGY, vol. 11, no. 2, pages 113 - 116 *
M. D'ADDATO ET AL.: "PREVENTION OF EARLY GRAFT INFECTION WITH RIFAMPICIN BONDED GELSEAL GRAFTS: A MULTICENTRE EXPERIMENTAL STUDY.", CARDIOVASCULAR SURGERY, vol. 2, no. 2, pages 254 - 258 *
SCOTT D. JENKINS ET AL.: "A COMPARISON OF PROSTHETIC MATERIALS USED TO REPAIR ABDOMINAL WALL DEFECTS.", SURGERY, vol. 94, no. 2, pages 392 - 398 *

Cited By (34)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6162962A (en) * 1996-03-26 2000-12-19 Ethicon Gmbh & Co., Kg Areal implant
DE19613730C2 (de) * 1996-03-26 2002-08-14 Ethicon Gmbh Flächiges Implantat zum Verstärken oder Verschließen von Körpergewebe
DE19613730A1 (de) * 1996-03-26 1997-10-02 Ethicon Gmbh Flächiges Implantat
US6113641A (en) * 1997-08-27 2000-09-05 Ethicon, Inc. Prosthesis for the obturation of a hernial canal
US6180848B1 (en) 1997-08-27 2001-01-30 Ethicon, Inc. Prosthesis obturating device for the obturation of a hernial canal
US6241768B1 (en) 1997-08-27 2001-06-05 Ethicon, Inc. Prosthetic device for the repair of a hernia
US8147478B2 (en) 2000-09-07 2012-04-03 Ams Research Corporation Coated sling material
FR2840801A1 (fr) * 2002-06-18 2003-12-19 Cie De Rech En Composants Impl Implant prothetique composite
WO2003105726A1 (fr) * 2002-06-18 2003-12-24 Compagnie De Recherche En Composants, Implants Et Materiels Pour L'application Clinique Implant prothetique composite
WO2005051448A1 (fr) * 2003-11-26 2005-06-09 Ethicon Gmbh Implant chirurgical
DE10355189B4 (de) * 2003-11-26 2015-04-30 Johnson & Johnson Medical Gmbh Verfahren zum Herstellen eines chirurgischen Implantats sowie chirurgisches Implantat
WO2006032497A1 (fr) 2004-09-24 2006-03-30 Aesculap Ag & Co. Kg Implant antimicrobien comprenant une structure poreuse souple
JP2008514248A (ja) * 2004-09-24 2008-05-08 アエスクラップ アーゲー ウント コー カーゲー 可撓性で多孔性の構造をもつ抗菌性埋入物
FR2865379A1 (fr) * 2005-03-02 2005-07-29 Cie De Rech En Composants Impl Implant prothetique composite
US8758373B2 (en) 2008-02-18 2014-06-24 Covidien Lp Means and method for reversibly connecting a patch to a patch deployment device
US9393093B2 (en) 2008-02-18 2016-07-19 Covidien Lp Clip for implant deployment device
US8317808B2 (en) 2008-02-18 2012-11-27 Covidien Lp Device and method for rolling and inserting a prosthetic patch into a body cavity
US8808314B2 (en) 2008-02-18 2014-08-19 Covidien Lp Device and method for deploying and attaching an implant to a biological tissue
US10695155B2 (en) 2008-02-18 2020-06-30 Covidien Lp Device and method for deploying and attaching an implant to a biological tissue
US10182898B2 (en) 2008-02-18 2019-01-22 Covidien Lp Clip for implant deployment device
US9005241B2 (en) 2008-02-18 2015-04-14 Covidien Lp Means and method for reversibly connecting a patch to a patch deployment device
US10159554B2 (en) 2008-02-18 2018-12-25 Covidien Lp Clip for implant deployment device
US9034002B2 (en) 2008-02-18 2015-05-19 Covidien Lp Lock bar spring and clip for implant deployment device
US9044235B2 (en) 2008-02-18 2015-06-02 Covidien Lp Magnetic clip for implant deployment device
US9107726B2 (en) 2008-02-18 2015-08-18 Covidien Lp Device and method for deploying and attaching an implant to a biological tissue
US9301826B2 (en) 2008-02-18 2016-04-05 Covidien Lp Lock bar spring and clip for implant deployment device
US9393002B2 (en) 2008-02-18 2016-07-19 Covidien Lp Clip for implant deployment device
US8753359B2 (en) 2008-02-18 2014-06-17 Covidien Lp Device and method for deploying and attaching an implant to a biological tissue
US9398944B2 (en) 2008-02-18 2016-07-26 Covidien Lp Lock bar spring and clip for implant deployment device
US9833240B2 (en) 2008-02-18 2017-12-05 Covidien Lp Lock bar spring and clip for implant deployment device
US8888811B2 (en) 2008-10-20 2014-11-18 Covidien Lp Device and method for attaching an implant to biological tissue
US9999424B2 (en) 2009-08-17 2018-06-19 Covidien Lp Means and method for reversibly connecting an implant to a deployment device
US8906045B2 (en) 2009-08-17 2014-12-09 Covidien Lp Articulating patch deployment device and method of use
RU2465654C1 (ru) * 2011-07-27 2012-10-27 Николай Александрович Пострелов Способ моделирования условий протезирующей герниопластики брюшной стенки

Also Published As

Publication number Publication date
EP0772468A1 (fr) 1997-05-14
GB9414746D0 (en) 1994-09-07
AU2987295A (en) 1996-02-22
JPH10503099A (ja) 1998-03-24

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