WO2000015141A1 - Preformed curved prosthesis that is adapted to the external iliac vessels - Google Patents
Preformed curved prosthesis that is adapted to the external iliac vessels Download PDFInfo
- Publication number
- WO2000015141A1 WO2000015141A1 PCT/US1999/020929 US9920929W WO0015141A1 WO 2000015141 A1 WO2000015141 A1 WO 2000015141A1 US 9920929 W US9920929 W US 9920929W WO 0015141 A1 WO0015141 A1 WO 0015141A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- prosthesis
- radius
- curvature
- prosthesis according
- approximately
- Prior art date
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
- A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
Definitions
- the present invention relates to an implantable prosthesis, and more particularly to a prosthesis for repairing a hernia.
- a flat sheet of an implantable, non-resorbable, flexible mesh material such as BARD MESH, has been employed for the parietal repair of hernias and eventrations of the abdominal wall.
- BARD MESH implantable, non-resorbable, flexible mesh material
- a surgeon may experience some difficulty positioning the mesh between the parietal peritoneum and the abdominopelvic wall. The mesh may also fold or wrinkle and be difficult to maintain in position.
- the prosthesis which is disclosed in WO 95/07666 and is assigned to C.R. Bard, the assignee of the present application, is made of an implantable, nonabsorbable and flexible material that is formed to independently assume a curved shape adapted to conform to the anatomical shape of the wall.
- the prosthesis includes a body comprised of a first portion formed in the shape of a cap and a second portion having a substantially spherical shape connected to a lower edge of the first portion.
- the second portion has a radius of curvature that is less than the radius of curvature of the first portion.
- the second portion includes an outer edge that meets the lower edge of the first portion at the apex of the body, which is the highest point of the curved prosthesis.
- This prosthesis has proven useful and has become established in the practice of muscle or tissue wall repair in the inguinofemoral region.
- the prosthesis is not subject to stresses when deformed and, therefore, has no tendency to shift upon implantation.
- the prosthesis reinforces the abdominal wall at the anatomical region of concern.
- the present invention is an implantable prosthesis for repairing a defect in a muscle or tissue wall.
- the prosthesis includes a body of prosthetic material having a preformed three- dimensional contoured shape that independently assumes a curved shape adapted to conform to the wall.
- the body is configured to adapt to the inclination of the external iliac vessels to facilitate a desired placement of the prosthesis when employed for repairing an inguinal hernia.
- the body includes a first portion with a first lower edge and a second portion with a second outer edge, the second portion being connected to the first portion at the first lower edge.
- the first portion is configured to have a shape of a cap and the second portion is configured with a substantially spherical shape.
- the first portion has a first radius of curvature and the second portion has a second radius of curvature that is less than the first radius of curvature.
- the second outer edge and the first lower edge meet at an apex of the body, the second outer edge forming an angle with the first lower edge that is greater than approximately 100° at the apex.
- the angle is between approximately 101 ° and approximately 120°.
- the first portion includes a first outer edge and the second portion includes a second outer edge
- the body further includes a third portion with a third lower edge and a fourth portion.
- the third portion is connected to the first outer edge and the fourth portion is connected to the third lower edge and to the second outer edge.
- a depression may be formed between the second and fourth portions which is configured to be placed proximate the external iliac vessels when the prosthesis is positioned on a wall to repair an inguinal hernia.
- the angular orientation between the first lower edge and the second outer edge and the depression between the second and fourth portions are adapted to the inclination of the external iliac vessels to facilitate placement of and to minimize shifting of the prosthesis when positioned on the wall.
- the angular orientation and the depression also provide a degree of deformation for matching adjacent contours.
- the prosthesis is configured with a ratio of the surface area of the third portion to the total surface area of the prosthesis from approximately 0.25 to approximately 0.40.
- the third portion has a third radius of curvature that is substantially equal to the first radius of curvature along the first outer edge. This configuration reduces the incidence of wrinkles or folds occuring between the first portion and the third portion so that the first and third portions do not partially cover each other upon or after implantation, thereby ensuring that the overall size of the prosthesis is sufficient to adequately cover the desired portion of the wall.
- Figure 1 is a plan view of a prosthesis according to one illustrative embodiment of the invention
- Figure 2 is a cross-sectional view of the prosthesis taken along section line II-II in Figure 1 ;
- Figure 3 is a cross-sectional view of the prosthesis taken along section line III-III in Figure 1.
- FIGS. 1-3 illustrate one embodiment of a prosthesis for repairing a defect in a muscle or tissue wall, such as a hernia.
- the prosthesis includes a body of prosthetic material that is preformed with a three-dimensional configuration that conforms to the anatomical shape of the defective wall to facilitate placement and minimize shifting of the prosthesis when positioned on the wall.
- the body includes a plurality of shaped portions that are joined to each other to create a desired configuration. The particular orientation between several portions of the body is adapted to the inclination of the external iliac vessels to facilitate a desired placement of the prosthesis when employed for repairing an inguinal hernia.
- the body includes first, second, third and fourth portions 1, 6, 10, 15, respectively, that are connected to each other to form a unitary structure.
- Each of the portions includes a curved surface that provide the prosthesis with the preformed contoured shape.
- the first portion 1 is formed with a substantially spherical shape and includes a first outer edge 2 and a first lower edge 3 joined to each other at an apex 4 of the prosthesis, which is the highest point thereof.
- the first portion 1 also includes a circular inner edge 5 that extends in the same plane as the outer and lower edges 2, 3.
- the second portion 6 is disposed below the first portion 1 and includes an upper edge 7, a second outer edge 8 and a curved second lower edge 9. As shown, the upper edge 7 merges with the first lower edge 3 of the first portion.
- the first and second portions 1, 6 are configured with an angle A at the apex 4 between the first lower edge 3 and the third outer edge 8 that positions the third outer edge 8 substantially opposite the external iliac vessels when implanted to repair an inguinal hernia. In one embodiment, the angle A is greater than 100° with an illustrative range of approximately 101 ° to 120°.
- the third portion 10, which lies adjacent the first portion 1, includes a third lower edge
- the third portion 10 is connected to the first portion 1 along the first outer edge 2.
- the fourth portion 15 is positioned below the third portion 10 and adjacent the second portion 6.
- the fourth portion 15 is defined by and is connected to the third lower edge 11 of the third portion 10 and the second outer edge 8 of the second portion 6.
- the fourth portion also includes a curved fourth lower edge 16.
- the inner edge 5, the third outer edge 14 and the second and fourth lower edges 9, 16 form a generally D-shaped peripheral edge of the prosthesis.
- the peripheral edge may be welded or fused so that the body can regain its contoured shape after being deformed during implantation.
- Each of the second and fourth portions 6, 15 may also have substantially spherical shapes to enhance conformance to a particular anatomical shape.
- the radius of curvature of the second and fourth portions is less than the radius of curvature of the first portion to form surfaces in the second and fourth portions that have a steeper incline relative to the first portion.
- the second and fourth portions are shaped to form a depression in the surface of the body that is configured to receive the external iliac vessels when the prosthesis is employed for inguinal hernia repair.
- the depression extends inwardly from the peripheral edge between the second and fourth lower edges 9, 16 toward the apex 4.
- the particular angular orientation between the first lower edge 3 and the second outer edge 8 and the depression between the second and fourth portions 6, 15 are adapted to the inclination of the external iliac vessels to facilitate placement of and to minimize shifting of the prosthesis when positioned on the wall.
- the angular orientation and the depression also provide a degree of deformation for matching adjacent contours.
- the prosthesis may also be configured to substantially reduce the incidence of wrinkles or folds between the first and third portions so that the first and third portions do not partially cover each other upon or after implantation, thereby ensuring that the overall size of the prosthesis is sufficient to adequately cover the desired portion of the wall.
- the first portion 1 has a first radius of curvature and the third portion 14 has a third radius of curvature that is substantially equal to the first radius of curvature along the first outer edge 2.
- the prosthesis may be formed from an implantable, biologically compatible material that is nonabsorbable and flexible.
- the prosthesis is formed of a knitted fabric of implantable polypropylene filament, such as BARD MESH, that includes a plurality of interstices (not shown) for promoting tissue ingrowth to the prosthesis. It is to be understood, however, that the prosthesis may be formed of any suitable material.
- the prosthesis may be configured to have any shape and size suitable for a particular application. In one embodiment, the height H of the prosthesis from a plane defined by the peripheral edge and the apex 4 is approximately 21 mm.
- the first portion 1 has a substantially spherical shape with a radius of curvature of approximately 120 mm, particularly along the first outer edge 2.
- the third portion 10 has substantially the same radius of curvature of approximately 120 mm adjacent the first outer edge 2.
- the second and fourth portions 6, 15 each has a substantially spherical shape with a radius of curvature of approximately 35 mm.
- the total surface area of the prosthesis is approximately 44,780 mm 2 , with the second portion 10 having a surface area of approximately 12,735 mm 2 .
- the disclosed configuration is particularly suited for repairing an inguinal hernia. It is to be appreciated, however, that this configuration is exemplary and that the prosthesis may be configured to have other shapes and sizes suitable for a particular application.
- the preformed curved shape of the prosthesis may be obtained using any suitable manufacturing process.
- the prosthesis is fabricated using a thermoforming procedure that includes placing a sheet of mesh fabric in a mold having the desired shape for the prosthesis, heating the fabric in the mold at an approximate temperature of 100°C to 200 °C for a period of approximately 5 to 60 minutes, and subsequently cooling the fabric in the mold with an air flow having an approximate temperature of l5°C to 30°C for a period of approximately 5 to 60 minutes.
- the edges of the prosthesis may be welded by fusing the meshes and the material using an ultrasonic welding procedure. During this procedure, the prosthesis is maintained between an element generating vibrations and an anvil that is configured to the particular dimensions of the prosthesis. In one embodiment, the edges are welded at a pressure of approximately 150 kPa to 800 kPa and an energy of approximately 100 to 5000 joules for a period of approximately 50 to 5000 milliseconds.
- any excess fabric extending beyond the welded edges is separated from the body of the prosthesis using a manual cutting procedure to form the completed prosthesis.
- the prosthesis may be packed in an internal packing (shell and insert) that has been designed specifically according to the three-dimensional characteristics of the prosthesis so as to comply with and protect the preformed curved shape of the prosthesis.
- the internal packing may be subsequently placed and packaged in a external packing for additional protection.
- the entire assembly may then be sterilized using any suitable method, such as with ethylene oxide, to provide a sterile prosthesis that is ready for implantation.
Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU58219/99A AU5821999A (en) | 1998-09-11 | 1999-09-10 | Preformed curved prosthesis that is adapted to the external iliac vessels |
US09/786,811 US6740122B1 (en) | 1998-09-11 | 1999-09-10 | Preformed curved prosthesis that is adapted to the external iliac vessels |
CA002343381A CA2343381C (en) | 1998-09-11 | 1999-09-10 | Preformed curved prosthesis that is adapted to the external iliac vessels |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR9811332A FR2783156B1 (en) | 1998-09-11 | 1998-09-11 | GALBE PROSTHETIC NET FITTING TO EXTERNAL ILIAC VESSELS |
FR98/11332 | 1998-09-11 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2000015141A1 true WO2000015141A1 (en) | 2000-03-23 |
Family
ID=9530319
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1999/020929 WO2000015141A1 (en) | 1998-09-11 | 1999-09-10 | Preformed curved prosthesis that is adapted to the external iliac vessels |
Country Status (4)
Country | Link |
---|---|
AU (1) | AU5821999A (en) |
CA (1) | CA2343381C (en) |
FR (1) | FR2783156B1 (en) |
WO (1) | WO2000015141A1 (en) |
Cited By (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6723133B1 (en) | 1998-09-11 | 2004-04-20 | C. R. Bard, Inc. | Performed curved prosthesis having a reduced incidence of developing wrinkles or folds |
WO2005044143A1 (en) * | 2003-10-31 | 2005-05-19 | Mpathy Medical Devices Limited | Hernia prosthesis |
US8118727B2 (en) | 2000-10-12 | 2012-02-21 | Coloplast A/S | Method for supporting pelvic anatomy |
US8157822B2 (en) | 2001-03-30 | 2012-04-17 | Coloplast A/S | Surgical implant and methods of use |
US8182412B2 (en) | 2000-10-12 | 2012-05-22 | Coloplast A/S | Pelvic implant with fibrous anchor |
US8215310B2 (en) | 2004-05-21 | 2012-07-10 | Coloplast A/S | Implant for treatment of vaginal and/or uterine prolapse |
US8668635B2 (en) | 2000-10-12 | 2014-03-11 | Coloplast A/S | Pelvic implant with suspending system |
US8920304B2 (en) | 2000-07-05 | 2014-12-30 | Coloplast A/S | Method and device for treating urinary incontinence |
US9005222B2 (en) | 2002-08-02 | 2015-04-14 | Coloplast A/S | Self-anchoring sling and introducer system |
US9186489B2 (en) | 2003-03-27 | 2015-11-17 | Coloplast A/S | Implantable delivery device system for delivery of a medicament to a bladder |
US11413129B2 (en) | 2020-06-19 | 2022-08-16 | Davol Inc. | Implantable prosthesis |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3559214A (en) * | 1968-10-17 | 1971-02-02 | William J Pangman | Compound prosthesis |
WO1995007666A1 (en) * | 1993-09-13 | 1995-03-23 | C.R. Bard, Inc. | Curved prosthetic mesh and method of manufacture |
US5584884A (en) * | 1995-07-27 | 1996-12-17 | Anthony S. Pignataro | Mammary prosthesis and method of surgically implanting same |
EP0836838A1 (en) * | 1996-10-18 | 1998-04-22 | Cogent | Anatomical prosthesis for hernia repair via open of laparoscopic surgery |
-
1998
- 1998-09-11 FR FR9811332A patent/FR2783156B1/en not_active Expired - Lifetime
-
1999
- 1999-09-10 WO PCT/US1999/020929 patent/WO2000015141A1/en active Application Filing
- 1999-09-10 CA CA002343381A patent/CA2343381C/en not_active Expired - Lifetime
- 1999-09-10 AU AU58219/99A patent/AU5821999A/en not_active Abandoned
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3559214A (en) * | 1968-10-17 | 1971-02-02 | William J Pangman | Compound prosthesis |
WO1995007666A1 (en) * | 1993-09-13 | 1995-03-23 | C.R. Bard, Inc. | Curved prosthetic mesh and method of manufacture |
US5584884A (en) * | 1995-07-27 | 1996-12-17 | Anthony S. Pignataro | Mammary prosthesis and method of surgically implanting same |
EP0836838A1 (en) * | 1996-10-18 | 1998-04-22 | Cogent | Anatomical prosthesis for hernia repair via open of laparoscopic surgery |
Cited By (54)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6723133B1 (en) | 1998-09-11 | 2004-04-20 | C. R. Bard, Inc. | Performed curved prosthesis having a reduced incidence of developing wrinkles or folds |
US10278800B2 (en) | 2000-07-05 | 2019-05-07 | Coloplast A/S | Method and device for treating urinary incontinence |
US8920304B2 (en) | 2000-07-05 | 2014-12-30 | Coloplast A/S | Method and device for treating urinary incontinence |
US8852075B2 (en) | 2000-10-12 | 2014-10-07 | Coloplast A/S | Pelvic implant systems and methods with expandable anchors |
US8469877B2 (en) | 2000-10-12 | 2013-06-25 | Coloplast A/S | System for introducing a pelvic implant |
US8118728B2 (en) | 2000-10-12 | 2012-02-21 | Coloplast A/S | Method for implanting an adjustable surgical implant for treating urinary incontinence |
US8123673B2 (en) | 2000-10-12 | 2012-02-28 | Coloplast A/S | Adjustable surgical implant for treating urinary incontinence |
US10449025B2 (en) | 2000-10-12 | 2019-10-22 | Coloplast A/S | Surgical device implantable to treat female urinary incontinence |
US10076394B2 (en) | 2000-10-12 | 2018-09-18 | Coloplast A/S | Method of treating urinary incontinence |
US8911347B2 (en) | 2000-10-12 | 2014-12-16 | Coloplast A/S | System and method for treating urinary incontinence |
US8182412B2 (en) | 2000-10-12 | 2012-05-22 | Coloplast A/S | Pelvic implant with fibrous anchor |
US8182413B2 (en) | 2000-10-12 | 2012-05-22 | Coloplast A/S | Method for fibrous anchoring of a pelvic support |
US9968430B2 (en) | 2000-10-12 | 2018-05-15 | Coloplast A/S | Surgical device implantable to treat female urinary incontinence |
US8273011B2 (en) | 2000-10-12 | 2012-09-25 | Coloplast A/S | Adjustable surgical implant and method for treating urinary incontinence |
US8449450B2 (en) | 2000-10-12 | 2013-05-28 | Coloplast A/S | Pass through introducer and sling |
US8454492B2 (en) | 2000-10-12 | 2013-06-04 | Coloplast A/S | Absorbable anchor and method for mounting mesh to tissue |
US8932202B2 (en) | 2000-10-12 | 2015-01-13 | Coloplast A/S | Incontinence implant with soft tissue anchors and length not allowing abdominal wall penetration |
US8512223B2 (en) | 2000-10-12 | 2013-08-20 | Coloplast A/S | Pelvic implant with selective locking anchor |
US8574148B2 (en) | 2000-10-12 | 2013-11-05 | Coloplast A/S | System for introducing soft tissue anchors |
US9918817B2 (en) | 2000-10-12 | 2018-03-20 | Coloplast A/S | Method of post-operatively adjusting a urethral support in treating urinary incontinence of a woman |
US9113992B2 (en) | 2000-10-12 | 2015-08-25 | Coloplast A/S | Apparatus and method for treating urinary incontinence |
US8888678B2 (en) | 2000-10-12 | 2014-11-18 | Coloplast A/S | Pelvic implant with suspending system |
US8668635B2 (en) | 2000-10-12 | 2014-03-11 | Coloplast A/S | Pelvic implant with suspending system |
US8801596B2 (en) | 2000-10-12 | 2014-08-12 | Coloplast A/S | Sling with support and suspending members formed from same polymer |
US8821370B2 (en) | 2000-10-12 | 2014-09-02 | Coloplast A/S | Device, system and methods for introducing soft tissue anchors |
US8821369B2 (en) | 2000-10-12 | 2014-09-02 | Colorplast A/S | Method for soft tissue anchoring with introducer |
US9089394B2 (en) | 2000-10-12 | 2015-07-28 | Coloplast A/S | Pelvic implant with suspending system |
US8118727B2 (en) | 2000-10-12 | 2012-02-21 | Coloplast A/S | Method for supporting pelvic anatomy |
US8162818B2 (en) | 2000-10-12 | 2012-04-24 | Coloplast A/S | Adjustable surgical implant for pelvic anatomy |
US9089396B2 (en) | 2000-10-12 | 2015-07-28 | Coloplast A/S | Urinary incontinence treatment and devices |
US8920308B2 (en) | 2000-10-12 | 2014-12-30 | Coloplast A/S | Surgical implant with anchor introducer channel |
US8632554B2 (en) | 2001-03-30 | 2014-01-21 | Coloplast A/S | Low mass density surgical implant having strands and methods of use |
US8157822B2 (en) | 2001-03-30 | 2012-04-17 | Coloplast A/S | Surgical implant and methods of use |
US10682213B2 (en) | 2001-03-30 | 2020-06-16 | Coloplast A/S | Surgical implant consisting of non-absorbable material |
US8157821B2 (en) | 2001-03-30 | 2012-04-17 | Coloplast A/S | Surgical implant |
US8603119B2 (en) | 2001-03-30 | 2013-12-10 | Coloplast A/S | Surgical implant having strands and methods of use |
US9943390B2 (en) | 2001-03-30 | 2018-04-17 | Coloplast A/S | Method of treating pelvic organ prolapse in a female patient by accessing a prolapsed organ trans-vaginally through a vagina |
US9248011B2 (en) | 2001-03-30 | 2016-02-02 | Coloplast A/S | Surgical implant and methods of use |
US8603120B2 (en) | 2001-03-30 | 2013-12-10 | Coloplast A/S | Low mass density surgical implant and methods of use |
US9872750B2 (en) | 2002-08-02 | 2018-01-23 | Coloplast A/S | Self-anchoring sling and introducer system |
US9532862B2 (en) | 2002-08-02 | 2017-01-03 | Coloplast A/S | Self-anchoring sling and introducer system |
US9532861B2 (en) | 2002-08-02 | 2017-01-03 | Coloplast A/S | Self-anchoring sling and introducer system |
US9005222B2 (en) | 2002-08-02 | 2015-04-14 | Coloplast A/S | Self-anchoring sling and introducer system |
US9555168B2 (en) | 2003-03-27 | 2017-01-31 | Coloplast A/S | System for delivery of medication in treatment of disorders of the pelvis |
US9345867B2 (en) | 2003-03-27 | 2016-05-24 | Coloplast A/S | Device implantable in tissue of a prostate gland or a bladder |
US9186489B2 (en) | 2003-03-27 | 2015-11-17 | Coloplast A/S | Implantable delivery device system for delivery of a medicament to a bladder |
GB2423030B (en) * | 2003-10-31 | 2008-01-30 | Mpathy Medical Devices Ltd | Hernia prosthesis |
WO2005044143A1 (en) * | 2003-10-31 | 2005-05-19 | Mpathy Medical Devices Limited | Hernia prosthesis |
GB2423030A (en) * | 2003-10-31 | 2006-08-16 | Mpathy Medical Devices Ltd | Hernia prosthesis |
US8215310B2 (en) | 2004-05-21 | 2012-07-10 | Coloplast A/S | Implant for treatment of vaginal and/or uterine prolapse |
US10064714B2 (en) | 2004-05-21 | 2018-09-04 | Coloplast A/S | Implantable device configured to treat pelvic organ prolapse |
US9060838B2 (en) | 2004-05-21 | 2015-06-23 | Coloplast A/S | Tissue supported implantable device |
US10639138B2 (en) | 2008-02-28 | 2020-05-05 | Coloplast A/S | Method for providing support to a urethra in treating urinary incontinence |
US11413129B2 (en) | 2020-06-19 | 2022-08-16 | Davol Inc. | Implantable prosthesis |
Also Published As
Publication number | Publication date |
---|---|
CA2343381A1 (en) | 2000-03-23 |
AU5821999A (en) | 2000-04-03 |
FR2783156A1 (en) | 2000-03-17 |
CA2343381C (en) | 2007-12-04 |
FR2783156B1 (en) | 2001-01-05 |
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