WO1997002789A1 - Surgical mesh fabric - Google Patents

Surgical mesh fabric Download PDF

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Publication number
WO1997002789A1
WO1997002789A1 PCT/US1996/011516 US9611516W WO9702789A1 WO 1997002789 A1 WO1997002789 A1 WO 1997002789A1 US 9611516 W US9611516 W US 9611516W WO 9702789 A1 WO9702789 A1 WO 9702789A1
Authority
WO
WIPO (PCT)
Prior art keywords
mesh
recited
hexagonal mesh
implantable dual
knit
Prior art date
Application number
PCT/US1996/011516
Other languages
French (fr)
Inventor
Milo A. Titone
Fred D. Herzog
Original Assignee
C.R. Bard, 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 C.R. Bard, Inc. filed Critical C.R. Bard, Inc.
Priority to BR9609352A priority Critical patent/BR9609352A/en
Priority to JP50597397A priority patent/JP3692540B2/en
Priority to EP96923738A priority patent/EP0837660B1/en
Priority to AU64592/96A priority patent/AU705361C/en
Priority to CA002224578A priority patent/CA2224578C/en
Priority to DE69608562T priority patent/DE69608562T2/en
Publication of WO1997002789A1 publication Critical patent/WO1997002789A1/en

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Classifications

    • D—TEXTILES; PAPER
    • D04—BRAIDING; LACE-MAKING; KNITTING; TRIMMINGS; NON-WOVEN FABRICS
    • D04B—KNITTING
    • D04B21/00—Warp knitting processes for the production of fabrics or articles not dependent on the use of particular machines; Fabrics or articles defined by such processes
    • D04B21/10—Open-work fabrics
    • D04B21/12—Open-work fabrics characterised by thread material
    • 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
    • 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
    • A61F2002/0068—Implantable repair or support meshes, e.g. hernia meshes having a special mesh pattern
    • 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
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
    • A61F2002/3011—Cross-sections or two-dimensional shapes
    • A61F2002/30112—Rounded shapes, e.g. with rounded corners
    • A61F2002/30113—Rounded shapes, e.g. with rounded corners circular
    • 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
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
    • A61F2002/3011—Cross-sections or two-dimensional shapes
    • A61F2002/30138—Convex polygonal shapes
    • A61F2002/30143—Convex polygonal shapes hexagonal
    • 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
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
    • A61F2002/3011—Cross-sections or two-dimensional shapes
    • A61F2002/30138—Convex polygonal shapes
    • A61F2002/30148—Convex polygonal shapes lozenge- or diamond-shaped
    • 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
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
    • A61F2002/3011—Cross-sections or two-dimensional shapes
    • A61F2002/30138—Convex polygonal shapes
    • A61F2002/30154—Convex polygonal shapes square
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0006—Rounded shapes, e.g. with rounded corners circular
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017—Angular shapes
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017—Angular shapes
    • A61F2230/0021—Angular shapes square
    • D—TEXTILES; PAPER
    • D10—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B2509/00—Medical; Hygiene
    • D10B2509/02—Bandages, dressings or absorbent pads
    • D—TEXTILES; PAPER
    • D10—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B—INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES
    • D10B2509/00—Medical; Hygiene
    • D10B2509/08—Hernia repair mesh
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T442/00—Fabric [woven, knitted, or nonwoven textile or cloth, etc.]
    • Y10T442/10—Scrim [e.g., open net or mesh, gauze, loose or open weave or knit, etc.]

Definitions

  • the present invention relates to a surgical mesh fabric and. more particularly, to a surgical mesh fabric for use in laparoscopic procedures.
  • Marlex mesh a single bar wa ⁇ knit, dual course Atlas polypropylene monofilament knit
  • Atlas polypropylene monofilament knit is exemplary of an implant material that has been successfully used in hernia repair.
  • prosthetic repair materials are placed in an open procedure where a two inch or longer incision is made through the abdominal wall, layers of healthy tissue are retracted to expose the void and then the rupture is filled or covered with the implantable fabric.
  • prosthetic surgical fabrics have been implanted laparoscopically which is a surgical procedure employing slender tubes (cannulas) that extend through narrow punctures in the abdominal wall.
  • the surgeon employs an illuminating optical instrument through one ofthe cannula to visualize the surgical site on a television monitor.
  • Surgical instruments are manipulated by the surgeon through other cannula in the abdominal wall, as the location ofthe instruments are observed on the monitor, to place the prosthetic repair material over or in the defect.
  • the present invention is a dual bar warp knit, hexagonal mesh fabric that is particularly suitable for use in laparoscopic hernia repair, although it is contemplated for classical open procedures as well.
  • the mesh fabric exhibits a favorable combination of physical and performance characteristics while still allowing the surgeon to see through the fabric during laparoscopy.
  • the prosthetic repair material is formed of polypropylene monofilament threads that have been dual bar wa ⁇ knitted into a large pore hexagonal mesh according to a back bar pattern chain of 2/0 2/4 2/0 4/6 4/2 4/6 and a front bar pattern chain of 4/6 4/2 4/6 2/0 2/4 2/0.
  • Fig. 1 is a photomicrograph (approximately 1 lx mag.) of a wa ⁇ knit dual bar, hexagonal mesh fabric according to the present invention.
  • Fig. 2 is the chain lapping pattern for the mesh fabric shown in Fig. 1.
  • the present invention is a surgical mesh fabric for reinforcing and closing soft tissue defects, and is particularly indicated for chest wall reconstruction and the repair of inguinal hernias.
  • the mesh fabric is formed of a biologically compatible, flexible and strong implantable material.
  • the dual bar (two partially threaded guide bars) wa ⁇ knit, diamond fabric includes large openings between adjacent yarn columns, ensuring good visibility ofthe underlying anatomy when the fabric is used in laparoscopic procedures without sacrificing mechanical properties of the mesh.
  • the porous character of the fabric allows tissue infiltration to inco ⁇ orate the prosthetic.
  • the dual bar construction provides a stable fabric which is resistant to unraveling
  • the knitted fabric is sufficiently strong to prevent pullout of anchoring sutures.
  • the flexible fabric may be collapsed into a slender configuration, such as a roll, which can be supported in. and advanced through, a narrow laparoscopic cannula.
  • the porous prosthetic repair fabric When knitted from polypropylene monofilament yarns, the porous prosthetic repair fabric allows a prompt fibroblastic response through the interstices of the mesh, forming a secure
  • the polypropylene monofilament fabric is inert in the presence of infection, non- wettable and has a low foreign body reaction.
  • the fabric illustrated in the lapping pattern and photomicrograph of Figs. 1-2, is a two bar warp knit, hexagonal mesh produced by using two partially threaded guide bars to knit the same pattern over three needles in a six course repeat.
  • the column portions are formed by two
  • a selvage edge may be formed using a double end of yarn and knitting over two empty needle spaces on each side ofthe band defining the band width.
  • the tension on the yarns may be greater when knitting the selvage as compared 0 to the body ofthe mesh to encourage the denser selvage to curl over itself in the direction of body of the mesh, forming a rigid edge member which can be grasped with laparoscopic tools during placement to help position the implant relative to the surgical site.
  • the fabric is washed with water and a cleaning agent, such as Triton
  • the pores have an elongated diamond to square shape, although other shapes including, without limitation, diamond, square, circular and near-circular, are contemplated so
  • the surgical mesh fabric preferably is knit from monofilament polypropylene, other monofilament and multifilament yarns that are biologically compatible may also be suitable as would be apparent to one of skill in the art. Fabric parameters, such as quality, stretch, and yarn size may vary depending upon the application. In a representative embodiment, the fabric is formed of 0.006 inch polypropylene monofilament yarn (160 denier) knitted on a 36 gauge machine, although other gauges are contemplated. The mesh sheets may be knitted in twelve inch widths, although other dimensions are contemplated. The surgeon may cut the mesh into smaller pieces or shapes, preferably with heated or ultrasonic instruments, to melt and seal the edges ofthe fabric. EXAMPLES
  • Mesh Thickness A 6" X 6" sample of mesh was placed on a standard fabric thickness gauge with a 1.29 inch diameter pressure foot and 10 oz. weight. The thickness was measured by lowering the foot on the middle ofthe sample and reading the thickness from the dial gauge, one reading per sample, to the nearest 0.001 inch.
  • Pore Size A sample of mesh was placed on an optical measurement device. The area of a shape that closely approximated the shape of a pore was calculated following acquisition of several reference points.
  • Burst Tester Hydraulic pressure was slowly increased causing a rubber diaphragm to inflate, contact the mesh, and burst the mesh. The peak pressure (psi) required to burst the mesh was recorded.
  • a 3.5" slit was cut parallel to the long dimension of a 3" x 8" piece of mesh. The slit was cut at the middle of one 3" side extending 3.5" into the sample.
  • the pounds load at a 40° angle was chosen as the value for comparison since it is about mid-way in the range of angular deflection (0-90°).

Abstract

A dual bar warp knit, hexagonal mesh fabric for use in hernia repair and to mend other muscle and tissue wall defects, produced according to a back bar pattern chain of 2/0 2/4 2/0 4/6 4/2 4/6 and a front bar pattern chain of 4/6 4/2 4/6 2/0 2/4 2/0.

Description

S JRGICAL MESH FABRIC
FIELD OF INVENTION
The present invention relates to a surgical mesh fabric and. more particularly, to a surgical mesh fabric for use in laparoscopic procedures.
BACKGROUND OF THE INVENTION
Various prosthetic repair materials have been proposed to reinforce the abdominal wall and to close abdominal wall defects. Marlex mesh, a single bar waφ knit, dual course Atlas polypropylene monofilament knit, is exemplary of an implant material that has been successfully used in hernia repair. Traditionally, prosthetic repair materials are placed in an open procedure where a two inch or longer incision is made through the abdominal wall, layers of healthy tissue are retracted to expose the void and then the rupture is filled or covered with the implantable fabric. Recently, prosthetic surgical fabrics have been implanted laparoscopically which is a surgical procedure employing slender tubes (cannulas) that extend through narrow punctures in the abdominal wall. Because the abdominal cavity remains closed, the surgeon employs an illuminating optical instrument through one ofthe cannula to visualize the surgical site on a television monitor. Surgical instruments are manipulated by the surgeon through other cannula in the abdominal wall, as the location ofthe instruments are observed on the monitor, to place the prosthetic repair material over or in the defect.
A concern has been raised that light may reflect off of the fabric surface during laparoscopy, potentially impairing visualization ofthe prosthetic repair material and the underlying anatomy. Increasing the pore size of a mesh fabric may improve laparoscopic observability but also may diminish the physical properties that had suggested the implant for augmenting or repairing abdominal wall defects. Many large pore mesh fabrics are known, such as the various openworks described in Paling, Warp Knitting Technology (Columbine Press). Although a dual bar warp knit, hexagonal mesh is described by Paling in Figs. 61 ϊ, 74 and 75 and at page 114, there is no indication or suggestion that such a fabric would be suitable as a prosthetic or that it would obviate the potential laparoscopic visualization concern.
Accordingly, there is a need for a mesh fabric suitable for hernia repair which combines the performance and physical characteristics of conventional prosthetic repair materials with good laparoscopic visibility. SIJMMARY OF THE INVENTION
The present invention is a dual bar warp knit, hexagonal mesh fabric that is particularly suitable for use in laparoscopic hernia repair, although it is contemplated for classical open procedures as well. The mesh fabric exhibits a favorable combination of physical and performance characteristics while still allowing the surgeon to see through the fabric during laparoscopy.
In one embodiment ofthe invention. the prosthetic repair material is formed of polypropylene monofilament threads that have been dual bar waφ knitted into a large pore hexagonal mesh according to a back bar pattern chain of 2/0 2/4 2/0 4/6 4/2 4/6 and a front bar pattern chain of 4/6 4/2 4/6 2/0 2/4 2/0.
It is among the general objects ofthe invention to provide a prosthetic mesh which combines good physical and performance properties with acceptable laparoscopic visibility.
It is a further object ofthe invention to provide an implantable fabric for laparoscopically repairing a tissue or muscle wall defect such as an inguinal hernia.
Other objects and features ofthe present invention will become apparent from the following detailed description when taken in connection with the accompanying drawings. It is to be understood that the drawings are designed for the puφose of illustration only and are not intended as a definition ofthe limits ofthe invention.
DESCRIPTION OF THE DRAWINGS
The foregoing and other objects and advantages ofthe invention will be appreciated more fully from the following drawings in which:
Fig. 1 is a photomicrograph (approximately 1 lx mag.) of a waφ knit dual bar, hexagonal mesh fabric according to the present invention; and
Fig. 2 is the chain lapping pattern for the mesh fabric shown in Fig. 1.
DESCRIPTION OF THE PREFERRED EMBODIMENT
The present invention is a surgical mesh fabric for reinforcing and closing soft tissue defects, and is particularly indicated for chest wall reconstruction and the repair of inguinal hernias. The mesh fabric is formed of a biologically compatible, flexible and strong implantable material. The dual bar (two partially threaded guide bars) waφ knit, diamond fabric includes large openings between adjacent yarn columns, ensuring good visibility ofthe underlying anatomy when the fabric is used in laparoscopic procedures without sacrificing mechanical properties of the mesh. The porous character of the fabric allows tissue infiltration to incoφorate the prosthetic. The dual bar construction provides a stable fabric which is resistant to unraveling
5 or running. The knitted fabric is sufficiently strong to prevent pullout of anchoring sutures. The flexible fabric may be collapsed into a slender configuration, such as a roll, which can be supported in. and advanced through, a narrow laparoscopic cannula.
When knitted from polypropylene monofilament yarns, the porous prosthetic repair fabric allows a prompt fibroblastic response through the interstices of the mesh, forming a secure
I o fibrous/prosthetic layer. The polypropylene monofilament fabric is inert in the presence of infection, non- wettable and has a low foreign body reaction.
The fabric, illustrated in the lapping pattern and photomicrograph of Figs. 1-2, is a two bar warp knit, hexagonal mesh produced by using two partially threaded guide bars to knit the same pattern over three needles in a six course repeat. The column portions are formed by two
15 separate ends of yarn crossing each other on two needles with the crossover portion traversing across a third needle. If one end of yarn breaks, a back up yarn will secure the fabric from at least two yarns away to prevent unraveling of the mesh. A selvage edge may be formed using a double end of yarn and knitting over two empty needle spaces on each side ofthe band defining the band width. The tension on the yarns may be greater when knitting the selvage as compared 0 to the body ofthe mesh to encourage the denser selvage to curl over itself in the direction of body of the mesh, forming a rigid edge member which can be grasped with laparoscopic tools during placement to help position the implant relative to the surgical site. Although a denser, knitted selvage is described, other arrangements of one or more edges ofthe fabric may be employed as would be apparent to one of skill in the art.
25 Following knitting, the fabric is washed with water and a cleaning agent, such as Triton
X-100. to remove processing lubricant. The mesh is dried at low temperature. The fabric is heat set under tension, in a crochet hoop or tentering frame, to provide the desired pore configuration. Preferably, the pores have an elongated diamond to square shape, although other shapes including, without limitation, diamond, square, circular and near-circular, are contemplated so
30 long as the porous fabric provides good visibility when used in laparoscopy while retaining the physical and performance properties necessary for an effective prosthetic repair of inguinal and chest wall defects. Although the surgical mesh fabric preferably is knit from monofilament polypropylene, other monofilament and multifilament yarns that are biologically compatible may also be suitable as would be apparent to one of skill in the art. Fabric parameters, such as quality, stretch, and yarn size may vary depending upon the application. In a representative embodiment, the fabric is formed of 0.006 inch polypropylene monofilament yarn (160 denier) knitted on a 36 gauge machine, although other gauges are contemplated. The mesh sheets may be knitted in twelve inch widths, although other dimensions are contemplated. The surgeon may cut the mesh into smaller pieces or shapes, preferably with heated or ultrasonic instruments, to melt and seal the edges ofthe fabric. EXAMPLES
The following examples are illustrative only and are not intended to limit the scope ofthe present invention.
Physical properties of a representative two bar warp knit, hexagonal mesh fabric were evaluated and compared to conventional mesh fabrics. The tested mesh fabric was formed in a Mayer RM6 knitter under the following parameters:
# of ends in body 210
# of ends in selvage 14 runner length 96" quality 16" take-up B/A 56/49 pattern chain 2/0 2/4 2/0 4/6 4/2 4/6 FB
4/6 4/2 4/6 2/0 2/4 2/0 BB gauge 36 width 12" lubricant mineral oil
Physical and performance characteristics were tested including mesh thickness, pore size, mesh density, stiffness, tensile strength, suture pullout, burst strength and tear resistance. Testing methodology and results appear below.
Mesh Thickness: A 6" X 6" sample of mesh was placed on a standard fabric thickness gauge with a 1.29 inch diameter pressure foot and 10 oz. weight. The thickness was measured by lowering the foot on the middle ofthe sample and reading the thickness from the dial gauge, one reading per sample, to the nearest 0.001 inch.
Pore Size: A sample of mesh was placed on an optical measurement device. The area of a shape that closely approximated the shape of a pore was calculated following acquisition of several reference points.
Mesh Density: The weight of a 5" x 5" piece of mesh was determined to the nearest 0.1 gram. The mesh was then placed in a partially filled graduated cylinder of water. After removal of air bubbles, the volume of displaced water was recorded to the nearest 0.1 cc. Density was calculated as: weight (grams) / volume water displaced (cc) - grams/cc
Minimum Suture Pullout (Suture Tear Resistance): A monofilament polypropylene suture
(size 3.0 or larger) was placed 2mm from the edge ofthe sample. The mesh was clamped in the lower jaw and the suture was attached to the upper jaw of an Instron Tensile Tester. The suture was then pulled out ofthe mesh at a rate of 5" per minute with an initial jaw separation of 2 -
2.5". The peak force required to pull out the suture was recorded. Each mesh was tested in two directions with the direction of lowest strength being reported here.
Burst Strength: A 6" x 6" piece of mesh was clamped in the fixture of a standard Mullen
Burst Tester. Hydraulic pressure was slowly increased causing a rubber diaphragm to inflate, contact the mesh, and burst the mesh. The peak pressure (psi) required to burst the mesh was recorded.
Minimum Tear Resistance: A 3.5" slit was cut parallel to the long dimension of a 3" x 8" piece of mesh. The slit was cut at the middle of one 3" side extending 3.5" into the sample. One
"leg" was placed in the lower jaw and one "leg" in the upper jaw of an Instron Tensile Tester. The sample was then pulled and a 3" tear completed. The peak force (lbs) required to tear the sample was recorded. Each mesh was tested in 4 different directions with the direction with lowest strength being reported here.
Minimum Tensile Strength: A 1" x 6" sample of mesh was placed in the jaws of an
Instron Tensile Tester with the long axis ofthe sample vertical. The sample was then pulled to break at a constant rate of traverse of 12 inches/minute with a jaw pressure of 60 psi and a gauge length of 2 inches. The force at break (lbs) was recorded. Each mesh was tested in both directions with the direction of lowest strength being reported here. Stiffness: A 1 " x 6" sample of mesh was placed in the clamping fixture of a Tinius Olsen Stiffness Tester. Once the sample had been mounted and the instrument zeroed, a force was applied to the specimen with a metal rod causing the sample to bend. At 10 degree increments of angular deflection, the percent load scale reading was recorded minus the initial percent load scale reading. The load (lbs) at each deflection angle was calculated as follows:
P = L x M/S where P = Pounds Load (lbs)
L = Load Scale reading (%)
M = Bending Moment (in lbs)
S = Bending Span (in)
The pounds load at a 40° angle was chosen as the value for comparison since it is about mid-way in the range of angular deflection (0-90°).
TABLE I
TEST VISILEX MARLEX PROLENE MERSILENE n=30 unless otherwise Mean ± SD Mean ± SD Mean ± SD Mean ± SD noted
Thickness (inches) 0.034 ± 0.001 0.027 ± 0.001 0.025 ± 0.001 Not Tested
Average Large Pore Area 0.0038 ± 0.0002 0.0008 ± 0.0001 0.0013 ± 0.0001 Not Tested (in2)
Mesh Density (grams/cc) 0.8 ± 0.04 0.93 ± 0.02 0.93 ± 0.02 Not Tested
Stiffness at 40° Bend (lbs) 0.018 ± 0.005 0.013 ± 0.002 0.036 ± 0.005 Not Tested N=29 N=6
Minimum Tensile Strength 38.97 ± 2.45 32.85 ± 3.19 54.4 ± 6.58 15.64 ± 0.71 (lbs.)
Minimum Suture Tear 8.32 ± 1.32 5.25 ± 0.78 7.53 ± 3.42 Not Tested Resistance (lbs)
Burst Strength (psi) 147 ± 6 ] 62 ± 10 250 ± 9 77 ± 3
Minimum Tear Resistance 1 1.64 ± 1.1 1 6.63 ± 2.38 5.42 ± 5.87 Not Tested (lbs) It should be understood that the foregoing description ofthe invention is intended merely to be illustrative thereof and that other equivalents, embodiments and modifications ofthe invention may apparent to those of skill in the art without departing from the scope or spirit thereof.

Claims

1. An implantable dual bar warp knit, hexagonal mesh, suitable for repair of a tissue or muscle wall defect, produced according to a back bar pattern chain of 2/0 2/4 2/0 4/6 4/2 4/6 and a front bar pattern chain of 4/6 4/2 4/6 2/0 2/4 2/0.
2. The implantable dual bar warp knit, hexagonal mesh recited in claim 1 formed of polypropylene monofilament yarns.
3. The implantable dual bar warp knit, hexagonal mesh recited in claim 1 including a body portion and a selvage that is more rigid than said body portion.
4. The implantable dual bar warp knit, hexagonal mesh recited in claim 1 wherein said more rigid selvage is curled.
5. The implantable dual bar warp knit, hexagonal mesh recited in claim 1 including elongated diamond to square pores.
6. The implantable dual bar warp knit, hexagonal mesh recited in claim 1 including circular pores.
7. The implantable dual bar waφ knit, hexagonal mesh recited in claim 1 including near circular pores.
8. The implantable dual bar waφ knit, hexagonal mesh recited in claim 1 including square pores.
9. The implantable dual bar waφ knit, hexagonal mesh recited in claim 1 including diamond pores.
10. The implantable dual bar warp knit, hexagonal mesh recited in claim 1 including yarn columns formed by two separate ends of yarn that cross each other on two needles with the crossover portion traversing across a third needle, wherein in one end of yarn breaks a back up yarn will secure the fabric from at least two yarns way to prevent unraveling ofthe mesh.
1 1. The implantable dual bar waφ knit, hexagonal mesh recited in claim 1 wherein said mesh is supported within a laparoscopic cannula.
PCT/US1996/011516 1995-07-13 1996-07-11 Surgical mesh fabric WO1997002789A1 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
BR9609352A BR9609352A (en) 1995-07-13 1996-07-11 Surgical mallet fabric
JP50597397A JP3692540B2 (en) 1995-07-13 1996-07-11 Surgical mesh cloth
EP96923738A EP0837660B1 (en) 1995-07-13 1996-07-11 Surgical mesh fabric
AU64592/96A AU705361C (en) 1995-07-13 1996-07-11 Surgical mesh fabric
CA002224578A CA2224578C (en) 1995-07-13 1996-07-11 Surgical mesh fabric
DE69608562T DE69608562T2 (en) 1995-07-13 1996-07-11 SURGICAL MESH TISSUE

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US08/502,021 US5569273A (en) 1995-07-13 1995-07-13 Surgical mesh fabric
US08/502,021 1995-07-13

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WO1997002789A1 true WO1997002789A1 (en) 1997-01-30

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US (1) US5569273A (en)
EP (1) EP0837660B1 (en)
JP (1) JP3692540B2 (en)
BR (1) BR9609352A (en)
DE (1) DE69608562T2 (en)
ES (1) ES2148778T3 (en)
WO (1) WO1997002789A1 (en)

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US9393002B2 (en) 2008-02-18 2016-07-19 Covidien Lp Clip for implant deployment device
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US8808314B2 (en) 2008-02-18 2014-08-19 Covidien Lp Device and method for deploying and attaching an implant to a biological tissue
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US10159554B2 (en) 2008-02-18 2018-12-25 Covidien Lp Clip for implant deployment device
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US9833240B2 (en) 2008-02-18 2017-12-05 Covidien Lp Lock bar spring and clip for implant deployment device
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US8317808B2 (en) 2008-02-18 2012-11-27 Covidien Lp Device and method for rolling and inserting a prosthetic patch into a body cavity
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US8906045B2 (en) 2009-08-17 2014-12-09 Covidien Lp Articulating patch deployment device and method of use
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EP0837660B1 (en) 2000-05-24
MX9710446A (en) 1998-08-30
DE69608562T2 (en) 2001-01-25
BR9609352A (en) 1999-08-17
JP2001519677A (en) 2001-10-23
US5569273A (en) 1996-10-29
AU6459296A (en) 1997-02-10
AU705361B2 (en) 1999-05-20
EP0837660A1 (en) 1998-04-29
DE69608562D1 (en) 2000-06-29
JP3692540B2 (en) 2005-09-07

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