WO1996003165A1 - Prostheses for the abdominal wall - Google Patents
Prostheses for the abdominal wall Download PDFInfo
- 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
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
Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP95925930A EP0772468A1 (en) | 1994-07-21 | 1995-07-20 | Prostheses for the abdominal wall |
JP8505567A JPH10503099A (en) | 1994-07-21 | 1995-07-20 | Prosthesis for abdominal wall |
AU29872/95A AU2987295A (en) | 1994-07-21 | 1995-07-20 | Prostheses for the abdominal wall |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB9414746A GB9414746D0 (en) | 1994-07-21 | 1994-07-21 | Prosthetic material |
GB9414746.9 | 1994-07-21 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1996003165A1 true WO1996003165A1 (en) | 1996-02-08 |
Family
ID=10758690
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/GB1995/001715 WO1996003165A1 (en) | 1994-07-21 | 1995-07-20 | Prostheses for the abdominal wall |
Country Status (5)
Country | Link |
---|---|
EP (1) | EP0772468A1 (en) |
JP (1) | JPH10503099A (en) |
AU (1) | AU2987295A (en) |
GB (1) | GB9414746D0 (en) |
WO (1) | WO1996003165A1 (en) |
Cited By (24)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE19613730A1 (en) * | 1996-03-26 | 1997-10-02 | Ethicon Gmbh | Flat implant |
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 (en) * | 2002-06-18 | 2003-12-19 | Cie De Rech En Composants Impl | A prosthetic implant used for the repair of hernias and ventral ruptures comprises a polyester or polypropylene textile support coated with a lyophilate of a biocompatible material, especially hyaluronic acid |
WO2005051448A1 (en) * | 2003-11-26 | 2005-06-09 | Ethicon Gmbh | Surgical implants for controlled release of medicaments |
FR2865379A1 (en) * | 2005-03-02 | 2005-07-29 | Cie De Rech En Composants Impl | Composite prosthetic implant useful for treating hernias or ruptures comprises a textile support coated with spongy bioadhesive coating of freeze-dried biocompatible material |
WO2006032497A1 (en) | 2004-09-24 | 2006-03-30 | Aesculap Ag & Co. Kg | Antimicrobial implant with a flexible porous structure |
US8147478B2 (en) | 2000-09-07 | 2012-04-03 | Ams Research Corporation | Coated sling material |
RU2465654C1 (en) * | 2011-07-27 | 2012-10-27 | Николай Александрович Пострелов | Method for simulating environment of replacing abdominal hernioplasty |
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)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR2846549B1 (en) * | 2002-11-04 | 2005-08-05 | Sofradim Production | PROSTHESIS OF REINFORCING TISSUE STRUCTURES |
DE102004051487A1 (en) * | 2004-10-21 | 2006-04-27 | Ethicon Gmbh | Surgical implant, useful for closing and covering soft tissue defects, e.g. for hernia repair, comprises a flat base having projections able to absorb body fluids |
Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0183365A2 (en) * | 1984-11-30 | 1986-06-04 | Vascutek Limited | Vascular graft |
-
1994
- 1994-07-21 GB GB9414746A patent/GB9414746D0/en active Pending
-
1995
- 1995-07-20 JP JP8505567A patent/JPH10503099A/en active Pending
- 1995-07-20 AU AU29872/95A patent/AU2987295A/en not_active Abandoned
- 1995-07-20 WO PCT/GB1995/001715 patent/WO1996003165A1/en not_active Application Discontinuation
- 1995-07-20 EP EP95925930A patent/EP0772468A1/en not_active Withdrawn
Patent Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0183365A2 (en) * | 1984-11-30 | 1986-06-04 | Vascutek Limited | Vascular graft |
Non-Patent Citations (3)
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)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6162962A (en) * | 1996-03-26 | 2000-12-19 | Ethicon Gmbh & Co., Kg | Areal implant |
DE19613730C2 (en) * | 1996-03-26 | 2002-08-14 | Ethicon Gmbh | Flat implant for strengthening or closing body tissue |
DE19613730A1 (en) * | 1996-03-26 | 1997-10-02 | Ethicon Gmbh | Flat implant |
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 (en) * | 2002-06-18 | 2003-12-19 | Cie De Rech En Composants Impl | A prosthetic implant used for the repair of hernias and ventral ruptures comprises a polyester or polypropylene textile support coated with a lyophilate of a biocompatible material, especially hyaluronic acid |
WO2003105726A1 (en) * | 2002-06-18 | 2003-12-24 | Compagnie De Recherche En Composants, Implants Et Materiels Pour L'application Clinique | Composite prosthetic implant |
WO2005051448A1 (en) * | 2003-11-26 | 2005-06-09 | Ethicon Gmbh | Surgical implants for controlled release of medicaments |
DE10355189B4 (en) * | 2003-11-26 | 2015-04-30 | Johnson & Johnson Medical Gmbh | Method for producing a surgical implant and surgical implant |
WO2006032497A1 (en) | 2004-09-24 | 2006-03-30 | Aesculap Ag & Co. Kg | Antimicrobial implant with a flexible porous structure |
JP2008514248A (en) * | 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 | Antibacterial implant with flexible and porous structure |
FR2865379A1 (en) * | 2005-03-02 | 2005-07-29 | Cie De Rech En Composants Impl | Composite prosthetic implant useful for treating hernias or ruptures comprises a textile support coated with spongy bioadhesive coating of freeze-dried biocompatible material |
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 (en) * | 2011-07-27 | 2012-10-27 | Николай Александрович Пострелов | Method for simulating environment of replacing abdominal hernioplasty |
Also Published As
Publication number | Publication date |
---|---|
JPH10503099A (en) | 1998-03-24 |
GB9414746D0 (en) | 1994-09-07 |
EP0772468A1 (en) | 1997-05-14 |
AU2987295A (en) | 1996-02-22 |
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