CA1322915C - Absorbable or nonabsorbable surgical repair mesh - Google Patents
Absorbable or nonabsorbable surgical repair meshInfo
- Publication number
- CA1322915C CA1322915C CA000479888A CA479888A CA1322915C CA 1322915 C CA1322915 C CA 1322915C CA 000479888 A CA000479888 A CA 000479888A CA 479888 A CA479888 A CA 479888A CA 1322915 C CA1322915 C CA 1322915C
- Authority
- CA
- Canada
- Prior art keywords
- mesh
- knitted
- yarn
- fabric
- filaments
- Prior art date
- Legal status (The legal status 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 status listed.)
- Expired - Fee Related
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
- A61F13/00—Bandages or dressings; Absorbent pads
-
- 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
-
- 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
- A61F2/02—Prostheses implantable into the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
-
- 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
- A61L31/04—Macromolecular materials
- A61L31/041—Mixtures of macromolecular compounds
-
- 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
- A61L31/04—Macromolecular materials
- A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- 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
- A61L31/148—Materials at least partially resorbable by the body
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29D—PRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE
- B29D5/00—Producing elements of slide fasteners; Combined making and attaching of elements of slide fasteners
- B29D5/04—Producing elements of slide fasteners; Combined making and attaching of elements of slide fasteners the interlocking members being formed by continuous meander of filamentary material
-
- 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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
-
- 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
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S425/00—Plastic article or earthenware shaping or treating: apparatus
- Y10S425/814—Zipper
-
- 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
- Y10T29/00—Metal working
- Y10T29/51—Plural diverse manufacturing apparatus including means for metal shaping or assembling
- Y10T29/5101—Slide fastener or slide fastener element
-
- 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
- Y10T29/00—Metal working
- Y10T29/53—Means to assemble or disassemble
- Y10T29/53291—Slide fastener
- Y10T29/53304—Means to assemble teeth onto stringer
Abstract
29,400 SURGICAL REPAIR MESH
ABSTRACT
A mesh or fabric, having zero or variable stretch, is made from absorbable or partially absorbable fibers. The mesh or fabric can be knitted. The fabric is useful in sur-gical repair.
ABSTRACT
A mesh or fabric, having zero or variable stretch, is made from absorbable or partially absorbable fibers. The mesh or fabric can be knitted. The fabric is useful in sur-gical repair.
Description
,400 1 322~ 1 5 SURGICAL REPAIR MESH
This invention is concerned with a mesh or fabric which may be either knit or woven. The ~abric is made trom either a tissue absorbable material such as polyglycolic acid (herein PGA) fibers, or from a partially tissue absorb-able material such as mixtures of PGA fibers and fibers of a nonabsorbable polyester or polyamide, or fibers of another medically acceptable nonabsorbable material. It is to be understood that the term polyglycolic acid is generic to both the homopolymer and to copolymers containing a glycolic acid ester linkage.
The mesh or fabric has varying amounts of stretch, including zero stretch in the warp or in the weft (fill.ng) direction.
The mesh or fabric may be useful in a wide variety of internal surgical procedures, e.g. as a tamponading device for pressure encapsulation and repair of traumatic-ally damaged organs such as the spleen, liver or kidney. The mesh or fabric may also be useful as a zero stretch or low stretch material e.g. in the repair of an abdominal wall defect, hernia, urinary tract, etc. Further, the mesh or fabric may be useful in areas of the cardiovascular system and in the brain. Still turther, the mesh or fabric may be useful in oral surgery, for example to repair de~ects and to encourage tissue ingrowth.
- 1322ql5 Although the dlmenslons and weight o~ the mesh are only llmlted by the practlcal slze for lts lntended use, dlmensions of from 4 x 4 lnches to 10 x 13 inches and welghts of 0.75 to 6.5 ounces per square yard can be normally used. Openlngs ln the mesh can range normally from zero to 1/4 lnch. The mesh can also be manufactured as a tubular prosthesis.
A drawlng whlch descrlbes the shape and~or geometrlcal conflguratlon of the mesh or fabrlc ls not necessary for an understandlng of thls lnventlon. That ls, any person skllled ln the mesh or fabrlc art wlll know how to manufacture and how to use the lnventlon by readlng thls speclflcatlon, generally and the examples, speclflcally.
In order to further stablllze the fabrlc, that ls to elimlnate horlzontal or vertlcal edge curllng and regulate stretch, the fabrlc may be heat set by holdlng both length and wldth to a speclfled dlmenslon wlthln a pln or cllp frame whlle exposlng the materlal to temperatures of g0 to 175C for perlods of 30 seconds to 15 mlnutes, preferably ln a vacuum. The fabrlc may also be heat set by holdlng both the length and wldth to a speclfled dlmenslon on a heated cyllnder whlle exposlng the materlal to temperatures of 90 to 175C for perlods of up to 4 hours ln a vacuum.
A knltted surglcal mesh has been lnvented. The mesh comprlses a plurallty of fllaments. Each fllament ls manufactured from a polymer havlng a glycollc acld ester llnkage. The fllaments are bundled or twisted lnto a yarn, and the yarn ls knltted ln a mesh.
The present inventlon provldes a stretchable, non-heat . ,, r ~~
-` 1 322q 1 5 set knltted surglcal mesh comprlslng a plurallty of fllaments, each fllament manufactured from a polymer havlng a glycollc acld ester llnkage, sald fllaments bundled or twlsted lnto a yarn, and sald yarn knltted lnto a mesh.
The present lnventlon also provldes a use of the knltted mesh accordlng to the present lnventlon ln surglcal repalr.
In one embodlment, the polymer ls a homopolymer. In another embodlment, the polymer ls a copolymer. In a more speclflc embodlment, the copolymer ls manufactured from glycollde and from trlmethylene carbonate.
In yet another embodlment, the yarn manufactured from the homopolymer ls greater than about 60 denler and contalns up to 4 plys. Each ply has greater than about 25 fllaments. In a more speciflc embodlment, the yarn ls up to about 150 denler, and the total number of fllaments per yarn ls up to about 75.
In stlll another embodlment, the yarn manufactured from the glycollde and trlmethylene carbonate copolymer ls about 65 to 85 denler. The yarn contalns about 5 to 25 filaments.
In stlll another embodlment, the knltted mesh ls manufactured on a 14 gauge trlcot knlttlng machlne whereln the stltch design ls Front Bar (2~0 2/4) x 2 (4/6 4~2) x 2 and Back Bar (4/6 4/2) x 2 t2~0 2~4) x 2 In yet another embodlment, the weight of the mesh ls about 4 to 10 o~.~sq. yd. In a further embodlment, the quallty of the mesh ls about 10 to 20 lnches per 480 courses.
, \
- ~3229~5 3a 61109-7390 A chaln stltched heat set knltted surglcal fabrlc has also been lnvented. The fabrlc comprlses a plurallty of fllaments. Each fllament is manufactured from a polymer havlng a glycollc acld ester llnkage. The fllaments are bundled or twlsted lnto a yarn, and the yarn ls knltted lnto a fabrlc.
In one embodlment, the polymer ls a homopolymer. In another embodlment, the polymer ls a copolymer. In a more speclflc embodiment, the copolymer ls manufactured from glycollde and from trlmethylene carbonate.
In yet another embodlment, the yarn manufactured from the polymer ls up to about 150 denler and contalns up to about 75 fllaments. In a more speclflc embodlment, the yarn ls about lO0 to 135 denler and contalns about 40 to 75 fllaments.
In still another embodiment, the knitted fabric is manufactured on a 48 gauge Raschel knitting machine wherein the stitch design is Front Bar: 1/0 0/1 and Back Bar: 1/0 4/5.
In yet another embodiment, the weight of the fabric is about 4 to 10 oz./sq. yd. In a further embodiment, the quality of the fabric is about 10 to 20 inches per 480 courses.
A woven surgical fabric has been invented. The woven fabric comprises a plurality of filaments. Each filament is manufactured from a polymer having a glycolic acid ester linkage. The filaments are twisted into a yarn, and the yarn is woven into a fabric.
In one embodiment, the polymer is a homopolymer.
In another embodiment, the polymer is a copolymer. In a more specific embodiment, the copolymer is manufactured trom glycolide and from trimethylene carbonate.
In yet another embodiment, the yarn manufactured trom the polymer is less than about 300 denier, and the yarn contains at least about 3 plys. In a more specific embodi-ment, the yarn is about 40 to 250 denier and contains about 5 plys. The total number of filaments per yarn is about 50 to 150.
In a still further embodiment, the warp yarn of the woven fabric has about 2 to 7 twists per inch and the filling yarn has about 1/2 to 5 twists per inch. In a yet further embodiment, the weight of the fabric is about 1 to 6 oz./sq. yd.
DETAILED DESCRIPTION
The fabric of the invention can be either a knitted or a woven ~abric. The fabric is of a medium weight.
One fabric of this invention, described more fully in Example 1 is a stretchable knit mesh. The mesh can be manu-factured on a 14 gauge tricot machine, or alternatively on a 28 gauge Raschel warp knit machine using a 2-bar construction.
On either ot these machines, the mesh is not heat set.
The yarn used in knitting the mesh can be between about 150 to 600 denier with between 1 and 5 turns per inch of twist. Preferably, the mesh has a lock stitch construction for nonravelling.
The usefulness of this fabric is primarily in the area of organ repair. Specifically, this fabric may be most useful in soft organ repair, e.g., the spleen, liver or kidney.
This fabric may also be useful in the repair of the pancreas.
Finally, the utility of this fabric is as an organ sling during internal healing of the organ. However, this fabric can also be used as a retraction sling ~or other purposes, e.g. as a retraction sling for irradiation therapy.
Another fabric described in Examples 2 and 3 is a semistretchable knit mesh. It can be knit on a 28 gauge tricot machine using a l-bar construction. The mesh can be knit from a yarn h~ving about 30 to 100 denier.
The usetulness of this semistretchable knit mesh is in abdominal wall repair, hernia repair, or in oral surgery, as a temporary support or as a packing material ~or en-couragement of tissue ingrowth.
Another fabric of this invention, which is describ-ed more fully in Examples 4 snd 5, is also a knit tabric. The ~abric is heat set without stretching, and is stabilized. The heat set can be on a tenter frame. The fabric can be manut'actured on a 24 gauge tricot or 48 gauge Raschel machine using a 2-bar construction.
The fabric can be between about 75 to 250 denier with between about 1/4 to 5 turns per inch. Preferably, the fabric is also manufactured using a chain stitch for stability.
The utility of this iabric can be in abdominal wall repair. Other uses can be for the repair of diaphragm defects.
Still other uses can be as a rectal support for recurrent pro-lapse. Finally, the fabric may be useful for tracheal malacia.
- Still another fabric of this invention, described in Examples 6 and 7, is a weave. The weave is stabilized. The fabric is manufactured on a loom.
The product is made from yarns of between about 150 to 350 denier. The warp yarn has between about 4 to 10 turns per inch of twist and the weft yarn has between about 1/4 to 5 turns per inch of twist. The weave can be plain or it can have other configurations, e.g. twill or satin. Finally, the woven ~abric has a water porosity of about zero to 1000 ml/min/cm2 at 120 mm of mercury.
Examples o~ typical fabrics or mesh as contemplated by this invention are given below:
Example 1 14 Gauge Tricot ~14 needles/inch) This example is a knitted mesh which has been neither stretched nor heat set.
A) Stitch design:
Front bar: (2/0 2/4) x 2, (4/6 4l2) x2 Back Bar: (4l6 4/2) x 2, (2/0 2/4) x 2 B) Yarn description:
3 ply 110 den.l50 fil. of polyglycolic acid (homopolymer~
C) Fabric Weight:
5.0 to 7.5 oz./s~. yd.
D) Fabric quality:
16 inches (per 480 courses) Example 2 28 Gauge Tricot (28 needles/inch) This homopolymer example of a prior art glycolide and lactide copolymer tight knitted mesh has been both stretched and heat set. Further the knitted mesh has been prestressed, i.e., stretched prior to heat setting.
A) Stitch Design:
Front bar: 1/0 1/2 Back bar: none B) Yarn description:
62 den. /28 fil. o~ polyglycolic acid (homopolymer) C) Fabric weight:
1.00 to 2.75 oz./sq. yd.
D) Fabric quality:
8 inches (per 480 courses) Example 3 28 Gauge Tricot (28 needles/inch) This glycolide and trimethylene carbonate copolymer example o~ a prior art glycolide and lactide copolymer tight knitted mesh has been both stretched and heat set. The stitch design is the same as Example 2. Further, the knitted mesh has been prestressed, i.e., stretched prior to heat setting.
A) Stitch design:
Front bar: 1/0 112 Back bar: none B~ Yarn description:
75 den./12 ~il. of a glycolide and trimethylene carbo-nate copolymer.
C) Fabric weight:
1.00 to 2.75 oz./sq. yd.
D) Fabric quality:
8 inches (per 4~0 courses) Example 4 48 Gauge Raschel or 24 Gauge Tricot (24 needles/inch) This example describes a knitted fabric which has beenheat set but not stretched.
A) Stitch design:
Front bar: 1/0 0/1 (chain stitch) Back bar: 1/0 4/5 B) Yarn description:
123 den./56 ~il. o~ polyglycolic acid (homopolymer) C) Fabric weight:
6.25 + .50 oz;/sq. yd.
D) Fabric quality:
14 inches (per 480 courses) Example 5 48 Gauge Raschel or 24 Gauge Tricot (24 needles/inch) This example describes a knitted ~abric which has ~een heat set but not stretched. The stitch design is the same as Example 4.
A) Stitch design:
Front bar: 1/0 0/1 (chain stitch) Back bar: 1/0 4/5 B) Yarn description:
110 den./50 fil. of polyglycolic acid (homopolymer) C) Fabric weight:
5.85 + .60 oz./sq. yd.
D) Fabric quality:
14 inches (per 480 courses) Example 6 1 x 1 Plain Woven Fabric .
This example teaches a woven ~abric which has been neither stretched nor heat set.
A) Warp yarn and ~illing yarns: 5 ply 46 denierl21 fil.
o~ polyglycolic acid (homopolymer) B) Warp yarn twist: 5 turns per inch C) Filling yarn twist: 1.5 turns per inch D) Fabric weight: 4.00 + .50 oz./sq. yd.
_ 9 _ Example 7 1 x 1 Plain Woven Fabric This example teaches a woven ~abric which has been neither stretched nor heat set.
A) Warp yarn and filling yarns: 250 denier/50 ~il. o~ a glycolide and trimethylene carbonate copolymer.
B) Warp yarn twist: 5 twists per inch C) Filling yarn twist: 1.5 twists per inch D) k`abric weight: 4.00 + .50 oz./sq. yd.
This invention is concerned with a mesh or fabric which may be either knit or woven. The ~abric is made trom either a tissue absorbable material such as polyglycolic acid (herein PGA) fibers, or from a partially tissue absorb-able material such as mixtures of PGA fibers and fibers of a nonabsorbable polyester or polyamide, or fibers of another medically acceptable nonabsorbable material. It is to be understood that the term polyglycolic acid is generic to both the homopolymer and to copolymers containing a glycolic acid ester linkage.
The mesh or fabric has varying amounts of stretch, including zero stretch in the warp or in the weft (fill.ng) direction.
The mesh or fabric may be useful in a wide variety of internal surgical procedures, e.g. as a tamponading device for pressure encapsulation and repair of traumatic-ally damaged organs such as the spleen, liver or kidney. The mesh or fabric may also be useful as a zero stretch or low stretch material e.g. in the repair of an abdominal wall defect, hernia, urinary tract, etc. Further, the mesh or fabric may be useful in areas of the cardiovascular system and in the brain. Still turther, the mesh or fabric may be useful in oral surgery, for example to repair de~ects and to encourage tissue ingrowth.
- 1322ql5 Although the dlmenslons and weight o~ the mesh are only llmlted by the practlcal slze for lts lntended use, dlmensions of from 4 x 4 lnches to 10 x 13 inches and welghts of 0.75 to 6.5 ounces per square yard can be normally used. Openlngs ln the mesh can range normally from zero to 1/4 lnch. The mesh can also be manufactured as a tubular prosthesis.
A drawlng whlch descrlbes the shape and~or geometrlcal conflguratlon of the mesh or fabrlc ls not necessary for an understandlng of thls lnventlon. That ls, any person skllled ln the mesh or fabrlc art wlll know how to manufacture and how to use the lnventlon by readlng thls speclflcatlon, generally and the examples, speclflcally.
In order to further stablllze the fabrlc, that ls to elimlnate horlzontal or vertlcal edge curllng and regulate stretch, the fabrlc may be heat set by holdlng both length and wldth to a speclfled dlmenslon wlthln a pln or cllp frame whlle exposlng the materlal to temperatures of g0 to 175C for perlods of 30 seconds to 15 mlnutes, preferably ln a vacuum. The fabrlc may also be heat set by holdlng both the length and wldth to a speclfled dlmenslon on a heated cyllnder whlle exposlng the materlal to temperatures of 90 to 175C for perlods of up to 4 hours ln a vacuum.
A knltted surglcal mesh has been lnvented. The mesh comprlses a plurallty of fllaments. Each fllament ls manufactured from a polymer havlng a glycollc acld ester llnkage. The fllaments are bundled or twisted lnto a yarn, and the yarn ls knltted ln a mesh.
The present inventlon provldes a stretchable, non-heat . ,, r ~~
-` 1 322q 1 5 set knltted surglcal mesh comprlslng a plurallty of fllaments, each fllament manufactured from a polymer havlng a glycollc acld ester llnkage, sald fllaments bundled or twlsted lnto a yarn, and sald yarn knltted lnto a mesh.
The present lnventlon also provldes a use of the knltted mesh accordlng to the present lnventlon ln surglcal repalr.
In one embodlment, the polymer ls a homopolymer. In another embodlment, the polymer ls a copolymer. In a more speclflc embodlment, the copolymer ls manufactured from glycollde and from trlmethylene carbonate.
In yet another embodlment, the yarn manufactured from the homopolymer ls greater than about 60 denler and contalns up to 4 plys. Each ply has greater than about 25 fllaments. In a more speciflc embodlment, the yarn ls up to about 150 denler, and the total number of fllaments per yarn ls up to about 75.
In stlll another embodlment, the yarn manufactured from the glycollde and trlmethylene carbonate copolymer ls about 65 to 85 denler. The yarn contalns about 5 to 25 filaments.
In stlll another embodlment, the knltted mesh ls manufactured on a 14 gauge trlcot knlttlng machlne whereln the stltch design ls Front Bar (2~0 2/4) x 2 (4/6 4~2) x 2 and Back Bar (4/6 4/2) x 2 t2~0 2~4) x 2 In yet another embodlment, the weight of the mesh ls about 4 to 10 o~.~sq. yd. In a further embodlment, the quallty of the mesh ls about 10 to 20 lnches per 480 courses.
, \
- ~3229~5 3a 61109-7390 A chaln stltched heat set knltted surglcal fabrlc has also been lnvented. The fabrlc comprlses a plurallty of fllaments. Each fllament is manufactured from a polymer havlng a glycollc acld ester llnkage. The fllaments are bundled or twlsted lnto a yarn, and the yarn ls knltted lnto a fabrlc.
In one embodlment, the polymer ls a homopolymer. In another embodlment, the polymer ls a copolymer. In a more speclflc embodiment, the copolymer ls manufactured from glycollde and from trlmethylene carbonate.
In yet another embodlment, the yarn manufactured from the polymer ls up to about 150 denler and contalns up to about 75 fllaments. In a more speclflc embodlment, the yarn ls about lO0 to 135 denler and contalns about 40 to 75 fllaments.
In still another embodiment, the knitted fabric is manufactured on a 48 gauge Raschel knitting machine wherein the stitch design is Front Bar: 1/0 0/1 and Back Bar: 1/0 4/5.
In yet another embodiment, the weight of the fabric is about 4 to 10 oz./sq. yd. In a further embodiment, the quality of the fabric is about 10 to 20 inches per 480 courses.
A woven surgical fabric has been invented. The woven fabric comprises a plurality of filaments. Each filament is manufactured from a polymer having a glycolic acid ester linkage. The filaments are twisted into a yarn, and the yarn is woven into a fabric.
In one embodiment, the polymer is a homopolymer.
In another embodiment, the polymer is a copolymer. In a more specific embodiment, the copolymer is manufactured trom glycolide and from trimethylene carbonate.
In yet another embodiment, the yarn manufactured trom the polymer is less than about 300 denier, and the yarn contains at least about 3 plys. In a more specific embodi-ment, the yarn is about 40 to 250 denier and contains about 5 plys. The total number of filaments per yarn is about 50 to 150.
In a still further embodiment, the warp yarn of the woven fabric has about 2 to 7 twists per inch and the filling yarn has about 1/2 to 5 twists per inch. In a yet further embodiment, the weight of the fabric is about 1 to 6 oz./sq. yd.
DETAILED DESCRIPTION
The fabric of the invention can be either a knitted or a woven ~abric. The fabric is of a medium weight.
One fabric of this invention, described more fully in Example 1 is a stretchable knit mesh. The mesh can be manu-factured on a 14 gauge tricot machine, or alternatively on a 28 gauge Raschel warp knit machine using a 2-bar construction.
On either ot these machines, the mesh is not heat set.
The yarn used in knitting the mesh can be between about 150 to 600 denier with between 1 and 5 turns per inch of twist. Preferably, the mesh has a lock stitch construction for nonravelling.
The usefulness of this fabric is primarily in the area of organ repair. Specifically, this fabric may be most useful in soft organ repair, e.g., the spleen, liver or kidney.
This fabric may also be useful in the repair of the pancreas.
Finally, the utility of this fabric is as an organ sling during internal healing of the organ. However, this fabric can also be used as a retraction sling ~or other purposes, e.g. as a retraction sling for irradiation therapy.
Another fabric described in Examples 2 and 3 is a semistretchable knit mesh. It can be knit on a 28 gauge tricot machine using a l-bar construction. The mesh can be knit from a yarn h~ving about 30 to 100 denier.
The usetulness of this semistretchable knit mesh is in abdominal wall repair, hernia repair, or in oral surgery, as a temporary support or as a packing material ~or en-couragement of tissue ingrowth.
Another fabric of this invention, which is describ-ed more fully in Examples 4 snd 5, is also a knit tabric. The ~abric is heat set without stretching, and is stabilized. The heat set can be on a tenter frame. The fabric can be manut'actured on a 24 gauge tricot or 48 gauge Raschel machine using a 2-bar construction.
The fabric can be between about 75 to 250 denier with between about 1/4 to 5 turns per inch. Preferably, the fabric is also manufactured using a chain stitch for stability.
The utility of this iabric can be in abdominal wall repair. Other uses can be for the repair of diaphragm defects.
Still other uses can be as a rectal support for recurrent pro-lapse. Finally, the fabric may be useful for tracheal malacia.
- Still another fabric of this invention, described in Examples 6 and 7, is a weave. The weave is stabilized. The fabric is manufactured on a loom.
The product is made from yarns of between about 150 to 350 denier. The warp yarn has between about 4 to 10 turns per inch of twist and the weft yarn has between about 1/4 to 5 turns per inch of twist. The weave can be plain or it can have other configurations, e.g. twill or satin. Finally, the woven ~abric has a water porosity of about zero to 1000 ml/min/cm2 at 120 mm of mercury.
Examples o~ typical fabrics or mesh as contemplated by this invention are given below:
Example 1 14 Gauge Tricot ~14 needles/inch) This example is a knitted mesh which has been neither stretched nor heat set.
A) Stitch design:
Front bar: (2/0 2/4) x 2, (4/6 4l2) x2 Back Bar: (4l6 4/2) x 2, (2/0 2/4) x 2 B) Yarn description:
3 ply 110 den.l50 fil. of polyglycolic acid (homopolymer~
C) Fabric Weight:
5.0 to 7.5 oz./s~. yd.
D) Fabric quality:
16 inches (per 480 courses) Example 2 28 Gauge Tricot (28 needles/inch) This homopolymer example of a prior art glycolide and lactide copolymer tight knitted mesh has been both stretched and heat set. Further the knitted mesh has been prestressed, i.e., stretched prior to heat setting.
A) Stitch Design:
Front bar: 1/0 1/2 Back bar: none B) Yarn description:
62 den. /28 fil. o~ polyglycolic acid (homopolymer) C) Fabric weight:
1.00 to 2.75 oz./sq. yd.
D) Fabric quality:
8 inches (per 480 courses) Example 3 28 Gauge Tricot (28 needles/inch) This glycolide and trimethylene carbonate copolymer example o~ a prior art glycolide and lactide copolymer tight knitted mesh has been both stretched and heat set. The stitch design is the same as Example 2. Further, the knitted mesh has been prestressed, i.e., stretched prior to heat setting.
A) Stitch design:
Front bar: 1/0 112 Back bar: none B~ Yarn description:
75 den./12 ~il. of a glycolide and trimethylene carbo-nate copolymer.
C) Fabric weight:
1.00 to 2.75 oz./sq. yd.
D) Fabric quality:
8 inches (per 4~0 courses) Example 4 48 Gauge Raschel or 24 Gauge Tricot (24 needles/inch) This example describes a knitted fabric which has beenheat set but not stretched.
A) Stitch design:
Front bar: 1/0 0/1 (chain stitch) Back bar: 1/0 4/5 B) Yarn description:
123 den./56 ~il. o~ polyglycolic acid (homopolymer) C) Fabric weight:
6.25 + .50 oz;/sq. yd.
D) Fabric quality:
14 inches (per 480 courses) Example 5 48 Gauge Raschel or 24 Gauge Tricot (24 needles/inch) This example describes a knitted ~abric which has ~een heat set but not stretched. The stitch design is the same as Example 4.
A) Stitch design:
Front bar: 1/0 0/1 (chain stitch) Back bar: 1/0 4/5 B) Yarn description:
110 den./50 fil. of polyglycolic acid (homopolymer) C) Fabric weight:
5.85 + .60 oz./sq. yd.
D) Fabric quality:
14 inches (per 480 courses) Example 6 1 x 1 Plain Woven Fabric .
This example teaches a woven ~abric which has been neither stretched nor heat set.
A) Warp yarn and ~illing yarns: 5 ply 46 denierl21 fil.
o~ polyglycolic acid (homopolymer) B) Warp yarn twist: 5 turns per inch C) Filling yarn twist: 1.5 turns per inch D) Fabric weight: 4.00 + .50 oz./sq. yd.
_ 9 _ Example 7 1 x 1 Plain Woven Fabric This example teaches a woven ~abric which has been neither stretched nor heat set.
A) Warp yarn and filling yarns: 250 denier/50 ~il. o~ a glycolide and trimethylene carbonate copolymer.
B) Warp yarn twist: 5 twists per inch C) Filling yarn twist: 1.5 twists per inch D) k`abric weight: 4.00 + .50 oz./sq. yd.
Claims (15)
1. A stretchable, non-heat set knitted surgical mesh comprising a plurality of filaments, each filament manufactured from a polymer having a glycolic acid ester linkage, said filaments bundled or twisted into a yarn, and said yarn knitted into a mesh.
2. A knitted mesh of claim 1 wherein said polymer is a homopolymer.
3. A knitted mesh of claim 1 wherein said polymer is a copolymer.
4. A knitted mesh of claim 3 wherein said polymer is manufactured from glycolide and from trimethylene carbonate.
5. A knitted mesh of claim 2 wherein said yarn is greater than about 60 denier and contains up to 4 plys, each ply having greater than about 25 filaments.
6. A knitted mesh of claim 4 wherein said yarn is about 65 to 85 denier and contains about 5 to 25 filaments.
7. A knitted mesh of claim 5 wherein said yarn is up to about 150 denier, and the total numbers of filaments per yarn is up to about 75.
8. A knitted mesh of claim 5 or 7 manufactured on a 14 gauge tricot knitting machine wherein the stitch design is Front Bar (2/0 2/4) x 2 (4/6 4/2) x 2 and Back Bar (4/6 4/2) x 2 (2/0 2/4) x 2
9. A knitted mesh of claim 8 wherein the weight of said mesh is about 4 to 10 oz./sq. yd.
10. A knitted mesh of claim 9 wherein the quality of said mesh is about 10 to 20 inches per 480 courses.
11. A use of a stretchable, non-heat set knitted surgical mesh according to any one of claims 1 to 10 in surgical repair.
12. The use according to claim 11 to tamponade an organ in a warm blooded mammal.
13. A chain stitched heat set knitted surgical fabric comprising a plurality of filaments, each filament manufactured from a polymer having a glycolic acid ester linkage, said filaments bundled or twisted into a yarn, and said yarn knitted into a fabric.
14. A use of the knitted fabric according to claim 13 in surgical repair.
15. The use according to claim 14 to tamponade an organ in a warm blooded mammal.
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US604,104 | 1984-04-26 | ||
US06/604,104 US4633873A (en) | 1984-04-26 | 1984-04-26 | Surgical repair mesh |
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Publication Number | Publication Date |
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CA1322915C true CA1322915C (en) | 1993-10-12 |
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ID=24418194
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Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA000479888A Expired - Fee Related CA1322915C (en) | 1984-04-26 | 1985-04-24 | Absorbable or nonabsorbable surgical repair mesh |
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US (2) | US4633873A (en) |
EP (1) | EP0159502B1 (en) |
JP (2) | JPS60234667A (en) |
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PT (1) | PT80340B (en) |
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ZA (1) | ZA853112B (en) |
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- 1984-04-26 US US06/604,104 patent/US4633873A/en not_active Expired - Fee Related
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1985
- 1985-03-07 DE DE85102559T patent/DE3587563T2/en not_active Expired - Lifetime
- 1985-03-07 SG SG1995905113A patent/SG30592G/en unknown
- 1985-03-07 EP EP85102559A patent/EP0159502B1/en not_active Expired - Lifetime
- 1985-03-29 IL IL74752A patent/IL74752A/en not_active IP Right Cessation
- 1985-04-18 PH PH32161A patent/PH23747A/en unknown
- 1985-04-22 JP JP60084677A patent/JPS60234667A/en active Granted
- 1985-04-23 PT PT80340A patent/PT80340B/en not_active IP Right Cessation
- 1985-04-24 CA CA000479888A patent/CA1322915C/en not_active Expired - Fee Related
- 1985-04-24 GR GR850997A patent/GR850997B/el unknown
- 1985-04-24 AU AU41641/85A patent/AU574457B2/en not_active Expired
- 1985-04-25 NO NO851663A patent/NO171485C/en unknown
- 1985-04-25 KR KR1019850002798A patent/KR930000688B1/en not_active IP Right Cessation
- 1985-04-25 ES ES542568A patent/ES8606919A1/en not_active Expired
- 1985-04-25 ZA ZA853112A patent/ZA853112B/en unknown
- 1985-04-25 FI FI851633A patent/FI86257C/en not_active IP Right Cessation
- 1985-04-25 DK DK186385A patent/DK169400B1/en not_active IP Right Cessation
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1986
- 1986-10-17 US US06/887,686 patent/US4838884A/en not_active Expired - Lifetime
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1995
- 1995-05-04 HK HK67895A patent/HK67895A/en not_active IP Right Cessation
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1998
- 1998-12-21 JP JP10362853A patent/JP2000093496A/en active Pending
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EP0159502A3 (en) | 1987-07-15 |
US4633873A (en) | 1987-01-06 |
PT80340A (en) | 1985-05-01 |
NO171485C (en) | 1993-03-24 |
DE3587563D1 (en) | 1993-10-14 |
EP0159502B1 (en) | 1993-09-08 |
NO851663L (en) | 1985-10-28 |
AU574457B2 (en) | 1988-07-07 |
US4838884A (en) | 1989-06-13 |
DE3587563T2 (en) | 1994-04-14 |
IL74752A0 (en) | 1985-06-30 |
KR930000688B1 (en) | 1993-01-29 |
PH23747A (en) | 1989-11-03 |
FI851633A0 (en) | 1985-04-25 |
DK169400B1 (en) | 1994-10-24 |
SG30592G (en) | 1995-09-18 |
JP2000093496A (en) | 2000-04-04 |
DK186385A (en) | 1985-10-27 |
JPH0554352B2 (en) | 1993-08-12 |
AU4164185A (en) | 1985-10-31 |
PT80340B (en) | 1987-05-29 |
NO171485B (en) | 1992-12-14 |
IL74752A (en) | 1991-08-16 |
FI851633L (en) | 1985-10-27 |
KR850007550A (en) | 1985-12-07 |
JPS60234667A (en) | 1985-11-21 |
FI86257C (en) | 1992-08-10 |
GR850997B (en) | 1985-11-25 |
ZA853112B (en) | 1985-12-24 |
FI86257B (en) | 1992-04-30 |
HK67895A (en) | 1995-05-12 |
DK186385D0 (en) | 1985-04-25 |
ES8606919A1 (en) | 1986-05-16 |
ES542568A0 (en) | 1986-05-16 |
EP0159502A2 (en) | 1985-10-30 |
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