EP3027796A1 - Method for making a lightweight quadriaxial surgical mesh - Google Patents
Method for making a lightweight quadriaxial surgical meshInfo
- Publication number
- EP3027796A1 EP3027796A1 EP14738961.3A EP14738961A EP3027796A1 EP 3027796 A1 EP3027796 A1 EP 3027796A1 EP 14738961 A EP14738961 A EP 14738961A EP 3027796 A1 EP3027796 A1 EP 3027796A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- filaments
- weave
- mesh
- loops
- axis
- 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.)
- Ceased
Links
- 238000000034 method Methods 0.000 title claims abstract description 23
- 239000004743 Polypropylene Substances 0.000 claims description 16
- 229920001155 polypropylene Polymers 0.000 claims description 16
- 239000000463 material Substances 0.000 claims description 10
- 238000000576 coating method Methods 0.000 claims description 8
- 102000008186 Collagen Human genes 0.000 claims description 7
- 108010035532 Collagen Proteins 0.000 claims description 7
- 229920001436 collagen Polymers 0.000 claims description 7
- 229920002994 synthetic fiber Polymers 0.000 claims description 6
- 239000011248 coating agent Substances 0.000 claims description 5
- 239000002033 PVDF binder Substances 0.000 claims description 4
- 229920002981 polyvinylidene fluoride Polymers 0.000 claims description 4
- 229920006362 Teflon® Polymers 0.000 claims description 3
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 claims description 3
- 239000004599 antimicrobial Substances 0.000 claims description 3
- 229920000728 polyester Polymers 0.000 claims description 3
- -1 polypropylene Polymers 0.000 claims description 3
- 229920001296 polysiloxane Polymers 0.000 claims description 3
- 239000004810 polytetrafluoroethylene Substances 0.000 claims description 3
- 229940058401 polytetrafluoroethylene Drugs 0.000 claims description 3
- BFKJFAAPBSQJPD-UHFFFAOYSA-N tetrafluoroethene Chemical compound FC(F)=C(F)F BFKJFAAPBSQJPD-UHFFFAOYSA-N 0.000 claims description 3
- 239000010936 titanium Substances 0.000 claims description 3
- 229910052719 titanium Inorganic materials 0.000 claims description 3
- 239000004809 Teflon Substances 0.000 claims description 2
- 230000008439 repair process Effects 0.000 description 20
- 206010046543 Urinary incontinence Diseases 0.000 description 13
- 210000001519 tissue Anatomy 0.000 description 12
- 238000009941 weaving Methods 0.000 description 12
- 239000004744 fabric Substances 0.000 description 7
- 210000003903 pelvic floor Anatomy 0.000 description 7
- 230000003628 erosive effect Effects 0.000 description 5
- 239000007943 implant Substances 0.000 description 5
- 239000011148 porous material Substances 0.000 description 5
- 206010060954 Abdominal Hernia Diseases 0.000 description 4
- 208000005422 Foreign-Body reaction Diseases 0.000 description 4
- 208000029836 Inguinal Hernia Diseases 0.000 description 4
- 210000000056 organ Anatomy 0.000 description 4
- 230000008901 benefit Effects 0.000 description 3
- 230000007547 defect Effects 0.000 description 3
- 239000000835 fiber Substances 0.000 description 3
- 229920001432 poly(L-lactide) Polymers 0.000 description 3
- 229920000117 poly(dioxanone) Polymers 0.000 description 3
- 229920000642 polymer Polymers 0.000 description 3
- 231100000241 scar Toxicity 0.000 description 3
- 206010011803 Cystocele Diseases 0.000 description 2
- 206010019909 Hernia Diseases 0.000 description 2
- 238000004040 coloring Methods 0.000 description 2
- 239000010432 diamond Substances 0.000 description 2
- 238000002513 implantation Methods 0.000 description 2
- 238000006467 substitution reaction Methods 0.000 description 2
- 210000000779 thoracic wall Anatomy 0.000 description 2
- 241000283690 Bos taurus Species 0.000 description 1
- 241000283073 Equus caballus Species 0.000 description 1
- 208000034347 Faecal incontinence Diseases 0.000 description 1
- 206010021639 Incontinence Diseases 0.000 description 1
- 206010056990 Intestinal prolapse Diseases 0.000 description 1
- 208000028484 Urethral disease Diseases 0.000 description 1
- 206010067784 Urethral prolapse Diseases 0.000 description 1
- 206010046814 Uterine prolapse Diseases 0.000 description 1
- 206010046940 Vaginal prolapse Diseases 0.000 description 1
- 210000003815 abdominal wall Anatomy 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 230000003416 augmentation Effects 0.000 description 1
- 210000001124 body fluid Anatomy 0.000 description 1
- 239000010839 body fluid Substances 0.000 description 1
- 210000001072 colon Anatomy 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 229910003460 diamond Inorganic materials 0.000 description 1
- 210000000188 diaphragm Anatomy 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 230000010354 integration Effects 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 230000003278 mimic effect Effects 0.000 description 1
- 210000003205 muscle Anatomy 0.000 description 1
- 239000005445 natural material Substances 0.000 description 1
- 238000002355 open surgical procedure Methods 0.000 description 1
- 230000008816 organ damage Effects 0.000 description 1
- 208000013823 pelvic organ prolapse Diseases 0.000 description 1
- 230000002085 persistent effect Effects 0.000 description 1
- 229920002463 poly(p-dioxanone) polymer Polymers 0.000 description 1
- 229920001610 polycaprolactone Polymers 0.000 description 1
- 239000000622 polydioxanone Substances 0.000 description 1
- 201000010727 rectal prolapse Diseases 0.000 description 1
- 238000002310 reflectometry Methods 0.000 description 1
- 230000002787 reinforcement Effects 0.000 description 1
- 230000003014 reinforcing effect Effects 0.000 description 1
- 210000004872 soft tissue Anatomy 0.000 description 1
- 210000000952 spleen Anatomy 0.000 description 1
- 238000007920 subcutaneous administration Methods 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 239000012209 synthetic fiber Substances 0.000 description 1
- 239000004753 textile Substances 0.000 description 1
- 230000000451 tissue damage Effects 0.000 description 1
- 230000009772 tissue formation Effects 0.000 description 1
- 210000003708 urethra Anatomy 0.000 description 1
- 201000003532 urethral intrinsic sphincter deficiency Diseases 0.000 description 1
- 230000002485 urinary effect Effects 0.000 description 1
- 210000002229 urogenital system Anatomy 0.000 description 1
- 239000013598 vector Substances 0.000 description 1
- 239000002759 woven fabric Substances 0.000 description 1
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
- A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
- A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
- A61F2/0036—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
- A61F2/0045—Support slings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- 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
- A61L31/048—Macromolecular materials obtained 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
- A61L31/04—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
- A61L31/08—Materials for coatings
- A61L31/10—Macromolecular materials
-
- 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
-
- 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
- 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
-
- 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
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
-
- 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
Definitions
- This invention relates to a textile material and, in particular, to a surgical mesh of knit construction fabricated using a quadrilateral pattern forming an isotropic mesh.
- Such mesh fabric prostheses are also used in other surgical procedures including the repair of anatomical defects of the abdominal wall, diaphragm, and chest wall, correction of defects in the genitourinary system, and repair of traumatically damaged organs such as the spleen, liver or kidney.
- the prosthetic surgical meshes can be implanted in either an open surgical procedure or through laparocsopic procedures (i.e. inserting specialized tools into narrow punctures made by the surgeon in the surrounding tissue).
- Mesh fabrics as well as knitted and woven fabrics constructed from a variety of synthetic fibers can be used to form the mesh used in surgical repair. It is desirable for a surgical mesh fabric to exhibit certain properties and characteristics.
- a mesh suitable for surgical applications should have a tensile strength sufficient to ensure that the mesh does not break or tear after it is implanted in a patient.
- the mesh should also have a pore size which allows tissue to penetrate or "grow through” the mesh, after the mesh has been implanted into a patient.
- the mesh should be constructed so as to maximize flexibility. Increased flexibility helps the mesh mimic the physiological characteristics of the bodily structure it is replacing or reinforcing. An added benefit of increased flexibility facilitates the insertion of the mesh prosthesis into a patient during a surgical operation.
- the heavyweight meshes are designed to provide the maximum strength for a durable and persistent repair of the hernia. Heavyweight meshes are formed using thick fibers, tend to have smaller pores, and a very high tensile strength. However, the heavyweight mesh may cause increased patient discomfort due to the increase in scar tissue formation.
- lightweight meshes have other drawbacks.
- they typically have a lower minimum tensile strength due to the smaller diameter of filament used and the "open" weave. This is also aggravated by the fact that such meshes are formed anisotropic and the differential between the tensile strength in any one of the directions of force can vary significantly.
- Another drawback to using lightweight meshes is that the anisotropic nature of the mesh has the tendency to cause the mesh to twist or deform when placed under tension, making placement more difficult.
- a surgical mesh fabric it is desirable for a surgical mesh fabric to have a tensile strength sufficient to ensure that the mesh does not break or tear after implantation into a patient.
- the minimum tensile strengths for meshes implanted for the augmentation and reinforcement of an existing bodily structure should be at least 16 N/cm.
- the tensile strength needed for meshes implanted to repair large abdominal hernias can increases to as much 32 N/cm.
- the invention is a lightweight knitted surgical mesh which includes a first axis, a second axis perpendicular to the first axis, a third axis offset approximately 30° to 60° from the first axis, and a fourth axis perpendicular to the third axis. Further the mesh has a first weave running parallel to the first axis, a second weave running parallel to the second axis, a third weave running parallel to the third axis, and a fourth weave running parallel to the fourth axis. In an embodiment, the third axis is offset 45° from the first axis.
- the first weave of the lightweight knitted surgical mesh can include a plurality of parallel filaments, wherein the filaments can be equidistantly or randomly spaced.
- at least two of the first, second, third, and fourth weaves include a plurality of parallel filaments, wherein the filaments for the weaves are equidistantly or randomly spaced.
- the filaments for the first weave, the second weave, the third weave, and the fourth weave are all equidistantly spaced to form an isotropic mesh.
- the first, second, third, and fourth weaves can include filaments which are at least one of monofilaments and multi-filaments.
- the filaments can have a diameter of 46 dTex and/or a diameter of 60 ⁇ m to 180 ⁇ m.
- the filaments can also have a tenacity of 20% to 35 % elongation.
- the lightweight knitted surgical mesh formed of the fibers can have a specific weight of approximately 25 to 200 g/m and a tensile strength greater than 16 N/cm or 32 N/cm.
- the first, second, third, and fourth weaves can include clear filaments and dyed filaments.
- the spacing between dyed filaments can 1 ⁇ 2 inch to 2 inches to formed a striped pattern. Further, a region of the mesh can be dyed to increase visibility.
- the filaments of the lightweight knitted surgical mesh can be made of polypropylene, polyester, or polyvinylidene fluoride. Further, the filament can be absorbable filaments and/or non-absorbable filaments. Additionally, the filaments can be coated with at least one of expanded poly-tetrafluoroethene/poly-tetrafluoroethylene, Teflon®, and biocompatible synthetic material.
- the mesh can also be coated with at least one of a biocompatible synthetic material, titanium, silicone, anti microbial agents, absorbable collagen, non-absorbable collagen, and harvested material.
- Figure 1 is a plan view of the surgical mesh of the present invention
- Figure 2 is a detail view of the mesh of Figure 1 ;
- Figures 3A, 3B, 3C, 3D, and 3E are weaving patterns of separate examples
- Figure 4 is a plan view of a sling for urinary incontinence (male or female) made of the mesh of the present invention
- Figure 5 is a plan view of a sling for urinary incontinence in females associated with a cystocele made of the mesh of the present invention
- Figure 6 is a plan view of a sling for urinary incontinence in females and for vaginal vault support made of the mesh of the present invention
- Figure 7 is a plan view of an inguinal hernia repair in men made of the mesh of the present invention.
- Figure 8 is a plan view of another inguinal hernia repair in men made of the mesh of the present invention.
- Figure 9 is a plan view of an abdominal wall hernias made of the mesh of the present invention.
- Figure 10 is a plan view of a sling for pelvic floor repair made of the mesh of the present invention.
- Figure 11 is a plan view of another sling for pelvic floor repair made of the mesh of the present invention.
- Figure 12 is a plan view of a further sling for urinary incontinence and pelvic floor repair made of the mesh of the present invention.
- Figure 13 is a plan view of a sling for urinary incontinence made of the mesh of the present invention.
- Figure 14 is a plan view of another sling for urinary incontinence made of the mesh of the present invention.
- Surgical mesh 100 can be surgically implanted in a patient to treat urinary or fecal incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency (ISD). Further, surgical mesh 100 can be implanted to reinforce soft tissue deficiencies. This includes, but is not limited to, pubourethral support and bladder support, urethral and vaginal prolapse repair, pelvic organ prolapse, colon and rectal prolapse repair, incontinence, reconstruction of the pelvic floor, sacral- colposuspension, abdominal wall hernias and chest wall defects. To accomplish the necessary support, mesh 100 can be made into pre-shaped designs, slings, three-dimensional plugs or flat sheets, as needed for each ailment to be corrected.
- Surgical mesh 100 is a two bar warp knitted structure.
- the mesh 100 is subject to numerous forces in tension. Forces are typically applied to the mesh along the X and Y axes X- X; Y-Y. Further, forces can be applied to the mesh along intermediate vectors between the X and Y axes. As illustrated, forces can be applied in T and W axes T-T, W-W.
- the angle between the X and W axes can be between 30° and 60°, and in one preferred embodiment, 45°.
- the angle between the Y and T axes can be between 30° and 60°, and in one preferred embodiment, 45°.
- the mesh is isotropic.
- the angle can similarly be measured between the X and T axes and the Y and W axes.
- mesh 100 is formed from a first weave 102 and a second weave 104.
- the first and second weaves 102, 104 are long filaments directed along two opposing axes.
- the weaves 102, 104 can be directed along the X and Y or W and T axes.
- Figures 1 and 2 illustrate the first and second weaves 102, 104 directed along the W and T axes.
- the W and T axes are perpendicular and the weaves are spaced equidistant from each other along each axis.
- the first and second weaves 102, 104 can form a square or diamond shape.
- the first weave 102 spacing can differ from the second weave 104 spacing and the two weaves can form rectangles.
- a third weave 106 and a fourth weave 108 are woven along the remaining two axes.
- third weave 106 is woven along the X-axis and the fourth weave 108 is woven along the Y-axis.
- the third and fourth weaves 106, 108 can be perpendicular to each other.
- the third and fourth weaves 106, 108 can form a square, diamond, or rectangular shapes based on their positioning and the spacing between adjacent weaves on the same axis and the opposing axis.
- the third and fourth weaves 106, 108 also intersect the first and second weaves 102, 104.
- all four weaves 102, 104, 106, 108 are interwoven with at least one other weave 102, 104, 106, 108 at the intersection points 110. This interweaving adds to the strength of the surgical weave along the four axes X, Y, T, W and provides the mesh 100 with an isotropic pattern, when the weaves are properly spaced.
- Figures 3A-3E illustrate different weaving examples that can be employed to form mesh 100.
- the pattern chain for the weaving pattern 200 is as illustrated.
- Figure 3 A shows weaving pattern 200 which represents a surgical mesh that can be manufactured on a single needle bed thanks to the use of four bars whose movements are represented in the same figure.
- the first yarn 202 creates wale structure, conferring stability to the fabric in the vertical direction.
- the two yarns of the wale, 204 and 206 interlace with the first yarn 202 creating a structure which is elastic and uniform.
- the last yarn 208 is the course that interlacing repeatedly to yarn 202 adds stability to the fabric in the transversal direction.
- Figure 3B illustrates a second weaving pattern 210.
- First, second, and third filaments 202, 204, 206 perform the same structural purposes as previously discussed. However, the first, second, and third filaments 202, 204, 206 have slightly different bar patterns and the fifth filament 212 (the fourth for pattern 210, but distinguished from fourth filament 208) is woven in a separate pattern.
- the pattern chain for the weaving pattern 210 is as illustrated.
- Figure 3C is a third weaving pattern 214.
- First, second, and third filaments 202, 204, 206 remain the same as previously discussed in Figure 3B, however, sixth filament 216 (the fourth for pattern 214, but distinguished from fourth filament 208 and fifth filament 212) is woven in a separate pattern.
- the pattern chain for the weaving pattern 214 is as illustrated.
- Figure 3D is a fourth weaving pattern 218.
- First, second, and third filaments 202, 204, 206 remain the same as previously discussed in Figure 3B, however, seventh filament 220 (the fourth for pattern 218, but distinguished from fourth filament 208, fifth filament 212, and sixth filament 216) is woven in a separate pattern.
- the pattern chain for the weaving pattern 218 is as illustrated.
- Figure 3E is a fifth weaving pattern 222.
- First filament 202 is weaved similar to first filament 202 in Figure 3A while the second and third filaments 204, 206 remain the same as previously discussed in Figure 3B.
- eighth filament 224 (the fourth for pattern 218, but distinguished from fourth filament 208, fifth filament 212, sixth filament 216, and seventh filament 220) is woven in a separate pattern.
- the pattern chain for the weaving pattern 222 is as illustrated.
- the first filament 202 forms the third weave 106.
- the second and third filaments 204, 206 form the first and second weaves 102, 104 and the fourth filament 208, fifth filament 212, sixth filament 216, seventh filament 220, and eighth filament 228 form the fourth weave 108.
- Each filament (first through eighth, 202, 204, 206, 208, 212, 216, 220, 224) can be a monofilament comprising a single strand of yarn or a multi-filament yarn.
- the diameter of the filaments can be between 60 ⁇ and 180 ⁇ .
- the diameter of the individual filaments (first through eighth, 202, 204, 206, 208, 212, 216, 220, 224) can be the same or different, depending on the use.
- the filaments can be made from polypropylene (PP), polyester, or polyvinylidene fluoride (PVDF).
- the individual filaments can be coated in expanded poly- tetrafluoroethene/poly-tetrafluoroethylene (ePTFE), Teflon ® and/or other biocompatible synthetic material. Further, certain sections of the filaments can be coated on one or both sides depending on use.
- ePTFE expanded poly- tetrafluoroethene/poly-tetrafluoroethylene
- Teflon ® Teflon ®
- the filaments can be an interwoven combination of PP and an absorbable polymer filament such as polyglactin (PGLA), poly-l-lactide acid (PLLA), polydioxanone/poly-p-dioxanone (PDO or PDS), polycaprolacton or polyglecaprone.
- PGLA polyglactin
- PLLA poly-l-lactide acid
- PDO or PDS polydioxanone/poly-p-dioxanone
- polycaprolacton or polyglecaprone reduces the amount of PP that remains in the body.
- one or more of the filaments (first through eighth, 202, 204, 206, 208, 212, 216, 220, 224) can be PP while the remaining filaments are an absorbable polymer.
- the PP mesh implant can be coated with an absorbable or non-absorbable polymer (PLLA, PGLA) on one or both sides or a portion of the implant mesh.
- PLLA absorbable or non-absorbable polymer
- the PP mesh implant can be coated with titanium, silicone, or anti microbial agents.
- the PP mesh implant can be coated, on one side or both, in the entirety or on only a portion, with a natural material such as collagen.
- the collagen can be equine, porcine or bovine and either is absorbable or non-absorbable.
- the PP mesh can be layered, either in whole or a portion, with harvested material (i.e. human cadaver tissue, or suitable non-human tissue). The use of collagen or harvested material prevents erosion of the tissue with which the mesh is in contact.
- the coating of the filaments and/ or mesh serves different purposes.
- the implantation of a mesh into the human body is best between two or more muscles. Surgical mesh implanted in contact with organs or tissue can form adhesions or erosions.
- Certain coatings above reduce the likelihood that the mesh will form adhesions or erode the organ or tissue it contacts.
- Part of the erosion problem is that when the mesh is trimmed to size, the cut edges remain rough and can cause tissue/organ damage over time.
- the texture of PP mesh itself causes a foreign body reaction so when it is in contact with organs or in a sub-cutaneous position the rates of adhesions and/or erosions are greater.
- coating too much of the surface of the mesh can reduce the mesh's ability to be integrated into the surrounding tissue, it is the foreign body reaction (FBR) of the PP mesh which causes the in growth of fibrous tissue into prosthetic material and the actual mesh fixation.
- FBR foreign body reaction
- absorbable coatings and filaments serves the purpose to increase the structural stability of the mesh, with out adding to the total load of PP in the patient.
- the additional absorbable fibers/coatings stiffen the mesh to make it easier for the surgeon to implant.
- the absorbency of the material is such that within a set period of time after the mesh in implanted (i.e. days to months) the material is absorbed into the body. This now gives the mesh a desired flexibility which can lead to reduced erosion and added comfort to the patient because the reduced FBR which results in a less dense fibrous tissue.
- one or more of the filaments can be colored.
- the colored filaments can be spaced apart to form stripes to improve visibility of the mesh 100 after it has become wet with body fluids.
- the spacing of the colored filament can be 1 ⁇ 2 inch to 2 inches apart.
- a portion of the mesh can be colored to aid in positioning the center of the mesh where it is necessary. For example, for placement of the mesh under the urethra, the central portion (2-4 cm 2 ) of the mesh can be colored.
- the coloring can be an FDA approved color for PP and in one embodiment, the filaments can be colored blue. In another embodiment, certain materials and finishes of the filaments can lead to a greater light reflectance. Filaments of higher reflectivity can be interwoven to form the same stripe or center identification pattern as coloring.
- the diameter of the filaments can be between 60 ⁇ and 180 ⁇ . In one embodiment, the filament is 80 ⁇ ⁇ 10%. This filament diameter corresponds to approximately 46 dTex.
- the filament can be spun to have a tenacity of approximately 4.5 cN/dTex. Further, the filament can have an elongation at break once stretched. In one embodiment, the tenacity can be from 20% to 35% elongation.
- the woven mesh can vary in thickness from 0.25 to 0.80 millimeters and in one embodiment is 0.32 mm ⁇ 10%.
- the mesh can have customarily weights approximately 30 g/m 2 ⁇ 8%.
- the specific weight of the mesh can vary between approximately 25 and 200 g/m 2 .
- the tensile strength of the mesh is at least 16 N/cm and can further be 32 N/cm. In one embodiment, the tensile strength is greater than 20 N/cm while still retaining an elasticity of 20%-35%.
- Figures 4-14 illustrate different examples of surgical slings made of the mesh of the present invention.
- the dimensions noted in the Figures are below in Table 1.
- Figure 4 illustrates a sling for urinary incontinence (male or female).
- Figure 5 illustrates a sling for urinary incontinence in females associated with a cystocele.
- Figure 6 illustrates a sling for urinary incontinence in females and for vaginal vault support.
- Figure 7 illustrates an inguinal hernia repair in men and the same configuration without the hole is for inguinal repair in women.
- Figure 8 illustrates another inguinal hernia repair in men.
- Figure 9 illustrates an abdominal wall hernia repair.
- Figure 10 illustrates a device for pelvic floor repair.
- Figure 11 illustrates another device for pelvic floor repair.
- Figure 12 illustrates a further sling for urinary incontinence and pelvic floor repair.
- Figure 13 illustrates a sling for urinary incontinence.
- Figure 14 illustrates another sling for urinary incontinence.
Landscapes
- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Surgery (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Cardiology (AREA)
- Transplantation (AREA)
- Biomedical Technology (AREA)
- Urology & Nephrology (AREA)
- Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Textile Engineering (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
- Knitting Of Fabric (AREA)
- Nonwoven Fabrics (AREA)
- Surgical Instruments (AREA)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US13/958,347 US9416471B2 (en) | 2008-06-27 | 2013-08-02 | Lightweight quadriaxial surgical mesh |
PCT/US2014/042517 WO2015017032A1 (en) | 2013-08-02 | 2014-06-16 | Method for making a lightweight quadriaxial surgical mesh |
Publications (1)
Publication Number | Publication Date |
---|---|
EP3027796A1 true EP3027796A1 (en) | 2016-06-08 |
Family
ID=51177164
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP14738961.3A Ceased EP3027796A1 (en) | 2013-08-02 | 2014-06-16 | Method for making a lightweight quadriaxial surgical mesh |
Country Status (9)
Country | Link |
---|---|
EP (1) | EP3027796A1 (pt) |
JP (1) | JP2016534241A (pt) |
KR (2) | KR20160070055A (pt) |
CN (2) | CN105765123A (pt) |
BR (1) | BR112016002313B1 (pt) |
CR (1) | CR20160058A (pt) |
MX (1) | MX2016001470A (pt) |
RU (1) | RU2675316C2 (pt) |
WO (1) | WO2015017032A1 (pt) |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2017122795A1 (ja) * | 2016-01-14 | 2017-07-20 | 学校法人大阪医科薬科大学 | 経編地及び医療材料 |
MX2020009106A (es) * | 2018-03-01 | 2023-01-09 | Titanium Textiles Ag | Tela tejida por urdimbre de metal de titanio libre de tensión para dar forma quirúrgicamente a tejidos blandos. |
MX2020009107A (es) * | 2018-03-01 | 2022-10-25 | Titanium Textiles Ag | Matriz de titanio a base de una tela tejida por urdimbre metálica libre de tensión para la regeneración guiada del tejido. |
Family Cites Families (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS5172588U (pt) * | 1974-12-05 | 1976-06-08 | ||
JP2791774B2 (ja) * | 1988-03-29 | 1998-08-27 | 株式会社福原精機製作所 | 丸編機におけるジャカード編地の製造方法 |
FR2791707B1 (fr) * | 1999-03-30 | 2001-05-25 | Aplix Sa | Tissu tricote a boucles de faible grammage |
FR2884706B1 (fr) * | 2005-04-22 | 2008-04-04 | Sofradim Production Sa | Tricot prothetique pour implants de soutien |
US7614258B2 (en) * | 2006-10-19 | 2009-11-10 | C.R. Bard, Inc. | Prosthetic repair fabric |
EP2002800B1 (en) * | 2007-06-11 | 2009-09-30 | Novus Scientific Pte. Ltd. | Mesh implant with an interlocking knitted structure |
US20090036996A1 (en) * | 2007-08-03 | 2009-02-05 | Roeber Peter J | Knit PTFE Articles and Mesh |
ITMI20081186A1 (it) * | 2008-06-27 | 2009-12-28 | Herniamesh S R L | Lightweight surgical mesh. |
RU2015108720A (ru) * | 2008-12-15 | 2015-08-10 | Аллерган, Инк. | Вязаная хирургическая имплантируемая сетка |
EP2486177B1 (en) * | 2009-10-05 | 2015-06-17 | Sofradim Production | Isoelastic porous mesh |
US9211175B2 (en) * | 2010-07-08 | 2015-12-15 | Covidien Lp | Self-detachable medical devices |
FR2979112B1 (fr) * | 2011-08-19 | 2013-08-16 | Sofradim Production | Tricot avec picots sur les deux faces |
-
2014
- 2014-06-16 EP EP14738961.3A patent/EP3027796A1/en not_active Ceased
- 2014-06-16 KR KR1020167005424A patent/KR20160070055A/ko not_active Application Discontinuation
- 2014-06-16 JP JP2016531612A patent/JP2016534241A/ja active Pending
- 2014-06-16 BR BR112016002313-7A patent/BR112016002313B1/pt active IP Right Grant
- 2014-06-16 MX MX2016001470A patent/MX2016001470A/es unknown
- 2014-06-16 RU RU2016104112A patent/RU2675316C2/ru active
- 2014-06-16 CR CR20160058A patent/CR20160058A/es unknown
- 2014-06-16 KR KR1020207035578A patent/KR20200143496A/ko not_active IP Right Cessation
- 2014-06-16 CN CN201480049599.6A patent/CN105765123A/zh active Pending
- 2014-06-16 CN CN201911188879.6A patent/CN111053627A/zh active Pending
- 2014-06-16 WO PCT/US2014/042517 patent/WO2015017032A1/en active Application Filing
Also Published As
Publication number | Publication date |
---|---|
MX2016001470A (es) | 2016-11-15 |
KR20200143496A (ko) | 2020-12-23 |
CN105765123A (zh) | 2016-07-13 |
RU2016104112A3 (pt) | 2018-03-07 |
BR112016002313A2 (pt) | 2017-08-01 |
RU2016104112A (ru) | 2017-09-07 |
KR20160070055A (ko) | 2016-06-17 |
RU2675316C2 (ru) | 2018-12-18 |
JP2016534241A (ja) | 2016-11-04 |
BR112016002313B1 (pt) | 2021-11-23 |
CR20160058A (es) | 2016-08-08 |
WO2015017032A1 (en) | 2015-02-05 |
CN111053627A (zh) | 2020-04-24 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US20090326565A1 (en) | Lightweight surgical mesh | |
US9416471B2 (en) | Lightweight quadriaxial surgical mesh | |
CA2858552C (en) | A prosthetic device and method of manufacturing the same | |
JP5985585B2 (ja) | 補綴デバイスおよびその製作方法 | |
CA2833540C (en) | A prosthetic device having regions of varying stretch and method of manufacturing the same | |
CA2789758C (en) | Bioabsorbable mesh for surgical implants | |
WO2013012635A2 (en) | Implantable silk prosthetic device and uses thereof | |
WO2012148735A1 (en) | A prosthetic device having diagonal yarns and method of manufacturing the same | |
WO2012170654A2 (en) | A prosthetic device and method of using in breast augmentation and/or breast reconstruction | |
WO2013012636A2 (en) | A prosthetic device and method of using in breast augmentation and/or breast reconstruction | |
WO2014149096A1 (en) | Silk medical device for use in breast augmentation and breast reconstruction | |
EP3027796A1 (en) | Method for making a lightweight quadriaxial surgical mesh | |
AU2012245669B2 (en) | A prosthetic device and method of manufacturing the same | |
NZ617461B2 (en) | A prosthetic device and method of manufacturing the same |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
PUAI | Public reference made under article 153(3) epc to a published international application that has entered the european phase |
Free format text: ORIGINAL CODE: 0009012 |
|
STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: REQUEST FOR EXAMINATION WAS MADE |
|
17P | Request for examination filed |
Effective date: 20160301 |
|
AK | Designated contracting states |
Kind code of ref document: A1 Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR |
|
AX | Request for extension of the european patent |
Extension state: BA ME |
|
DAX | Request for extension of the european patent (deleted) | ||
RIN1 | Information on inventor provided before grant (corrected) |
Inventor name: TRABUCCO, ERMANNO, E. Inventor name: CREPALDI, PIER ALDO |
|
STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: EXAMINATION IS IN PROGRESS |
|
17Q | First examination report despatched |
Effective date: 20210408 |
|
STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: EXAMINATION IS IN PROGRESS |
|
REG | Reference to a national code |
Ref country code: DE Ref legal event code: R003 |
|
STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: THE APPLICATION HAS BEEN REFUSED |
|
18R | Application refused |
Effective date: 20240112 |