CN111053627A

CN111053627A - Method of making a lightweight quadriaxial surgical mesh

Info

Publication number: CN111053627A
Application number: CN201911188879.6A
Authority: CN
Inventors: E.E.特拉布科; P.A.克雷帕尔迪
Original assignee: E ETelabuke; Herniamesh Srl
Current assignee: E ETelabuke; Herniamesh Srl; Herniammesh Srl
Priority date: 2013-08-02
Filing date: 2014-06-16
Publication date: 2020-04-24
Also published as: MX2016001470A; BR112016002313A2; RU2016104112A; EP3027796A1; KR20160070055A; RU2675316C2; CN105765123A; CR20160058A; RU2016104112A3; BR112016002313B1; KR20200143496A; JP2016534241A; WO2015017032A1

Abstract

A method of making a lightweight, four-axis surgical mesh is disclosed. The method comprises the following steps: a first set of filaments is applied in a first wale direction and forms a first series of loops at each of the plurality of transverse stripes. A second set of filaments is applied in a first wale direction and a second series of loops is formed at a first adjacent wale adjacent to the first wale direction and a third series of loops is formed at a second adjacent wale opposite the first adjacent wale along the plurality of transverse stripes. In addition, a third set of filaments is applied in the first wale direction such that a second series of loops is formed at a second adjacent wale and a third series of loops is formed at the first adjacent wale along the plurality of transverse stripes. Additionally, a fourth set of filaments is applied, the fourth set of filaments being repeatedly interlaced with the first set of filaments along the first wale direction.

Description

Method of making a lightweight quadriaxial surgical mesh

The applicant is: hermite, ltd, e.e. terabouco, filed on the date: 6/16/2014, with application numbers: 201480049599.6, the name is: divisional application of the invention of a method of making a lightweight, four-axis surgical mesh.

Cross Reference to Related Applications

The present application claims priority from us application No.13/958347 filed on 8/2/2013, which is a continuation-in-part of us application No.12/454308 filed on 5/15/2009, and us application No.12/454308 also claims priority from italian patent application No. m 2008a001186 filed on 27/2008, 6/119, in accordance with 35 u.s.c. All of the above applications are incorporated herein by reference in their entirety.

Technical Field

The present invention relates to a textile material, and more particularly to a surgical mesh of knitted construction made using quadrilateral patterns forming an isotropic mesh.

Background

Hernia repair is a relatively common surgical procedure that may use mesh fabric prostheses. Such mesh prostheses are also used in other surgical procedures, including repairing anatomical defects of the abdominal wall, diaphragm and chest wall, correcting defects in the urogenital system, and repairing injured organs, such as the spleen, liver or kidney.

The artificial surgical mesh can be implanted in an open surgical procedure or via a laparoscopic procedure (i.e., a specialized tool is inserted into a narrow hole made in the surrounding tissue by the surgeon).

Mesh fabrics, as well as knitted and woven fabrics composed of a variety of synthetic fibers, may be used to form meshes for use in surgical repair. Surgical meshes are expected to exhibit certain properties and characteristics. In particular, a mesh for surgical applications should have a tensile strength sufficient to ensure that the mesh does not break or tear after implantation into a patient. The mesh should also have a pore size that allows tissue to penetrate or "grow through" the mesh after the mesh is implanted in a patient. Furthermore, the mesh should be configured to maximize flexibility. The increased flexibility helps the mesh to mimic the physiological properties of the bodily structure it replaces or enhances. The additional benefit of increased flexibility facilitates insertion of the mesh prosthesis into the patient during a surgical procedure.

There are competing mesh design concepts, one of which is the use of heavy meshes with small pore sizes or light meshes with large pore sizes. Heavy mesh is designed to provide maximum strength for a durable and secure repair of hernias. Heavy webs are formed using thick fibers and are intended to have relatively small pore sizes and very high tensile strengths. However, a heavy mesh may lead to increased patient discomfort due to increased scar tissue formation.

The light, large pore size mesh is better suited for physiological repair of the body and allows proper tissue integration. These meshes provide the possibility of forming a mesh of scars rather than a stiff scar plate, thereby helping to avoid previously known complications of meshes.

However, lightweight meshes have other drawbacks. First, the filaments used generally have a lower minimum tensile strength due to their smaller diameter and "open" weave. This is further exacerbated by the fact that such a mesh is formed anisotropically, and the difference in tensile strength in either direction of force can vary significantly. Another disadvantage of using a light mesh is that the anisotropic nature of the mesh has a tendency to cause the mesh to twist or deform when under tension, making placement more difficult.

In addition, it is desirable that the surgical mesh have a tensile strength sufficient to ensure that the mesh does not break or tear after implantation into a patient. The minimum tensile strength of the mesh implanted to augment or reinforce an existing body structure should be at least 16N/cm. The tensile strength required to implant a mesh for the repair of a large ventral hernia can be increased to 32N/cm.

These and other objects and advantages of the present invention, which will be understood or appreciated by those skilled in the art upon practicing the present invention, will become more fully apparent from the following description and appended claims.

Disclosure of Invention

The present invention is a light knit surgical mesh comprising a first axis, a second axis perpendicular to the first axis, a third axis offset from the first axis by about 30 ° to 60 °, and a fourth axis perpendicular to the third axis. In addition, the mesh has a first braid extending parallel to the first axis, a second braid extending parallel to the second axis, a third braid extending parallel to the third axis, and a fourth braid extending parallel to the fourth axis. In an embodiment, the third axis is offset 45 ° from the first axis.

The first braid of the light knit surgical mesh may comprise a plurality of parallel filaments, wherein the filaments may be equally or randomly spaced. Alternatively, at least two of the first, second, third and fourth braids include a plurality of parallel filaments, wherein the filaments of the braids are equally or randomly spaced. In one embodiment, the filaments of the first braid, the second braid, the third braid, and the fourth braid are all equally spaced to form an isotropic mesh.

The first, second, third, and fourth braids may include filaments that are at least one of monofilament or multifilament. The filaments may have a diameter of 46dTex and/or a diameter of 60 μm to 180 μm. The filaments may also have a tenacity of 20% to 35% elongation. The light knit surgical mesh formed from fibers can have about 25 to 200g/m²The sum of specific gravities of more than 16N/cTensile strength of m or 32N/cm.

The first, second, third, and fourth braids may include clear filaments and dyed filaments. The spacing between dyed filaments may be 1/2 inches to 2 inches to form a striped pattern. In addition, areas of the mesh may be dyed to increase visibility.

The filaments of the light knit surgical mesh may be made of polypropylene, polyester, or polyvinylidene fluoride. Additionally, the filaments may be absorbable filaments and/or non-absorbable filaments. Additionally, the filaments may be made of expanded polytetrafluoroethylene,

And a biocompatible synthetic material.

The mesh may also be coated with at least one of a biocompatible synthetic material, titanium, silicone, an antimicrobial agent, absorbable collagen, non-absorbable collagen, and harvested material (harvested material).

Drawings

The above and other objects, features and advantages of the present invention will become apparent upon consideration of the following detailed description of specific embodiments thereof, particularly when taken in conjunction with the accompanying drawings, wherein like reference numerals in the various figures are utilized to designate like components, and in which:

FIG. 1 is a plan view of a surgical mesh of the present invention;

FIG. 2 is a detailed view of the mesh of FIG. 1;

3A, 3B, 3C, 3D and 3E are weave patterns for a single example;

FIG. 4 is a plan view of a strap for urinary incontinence (male or female) made from the web of the present invention;

FIG. 5 is a plan view of a band made from the mesh of the present invention for use in urinary incontinence in women with cystoceles;

FIG. 6 is a plan view of a strap for a female urinary incontinence and vaginal vault support made from the mesh of the present invention;

FIG. 7 is a plan view of a male inguinal hernia repair made from the mesh of the present invention;

FIG. 8 is a plan view of another male inguinal hernia repair made from a mesh of the present invention;

FIG. 9 is a plan view of a hernia of the abdominal wall made from the mesh of the present invention;

FIG. 10 is a plan view of a band for pelvic floor repair made from mesh of the present invention;

FIG. 11 is a plan view of another strap for pelvic floor repair made from the mesh of the present invention;

FIG. 12 is a plan view of another strap for urinary incontinence and pelvic floor repair made from the mesh of the present invention;

FIG. 13 is a plan view of a band for urinary incontinence made from the web of the present invention; and

fig. 14 is a plan view of another strap for urinary incontinence made from the web of the present invention.

Detailed Description

Referring to fig. 1, a surgical mesh 100 of the present invention is shown. The surgical mesh 100 may be surgically implanted into a patient to treat urinary or fecal incontinence caused by hypermotility of the urethra or Internal Sphincter Deficiency (ISD). In addition, the surgical mesh 100 can be implanted to augment soft tissue defects. This includes, but is not limited to, pubic urethral and bladder stents, urethral and vaginal prolapse repair, pelvic organ prolapse, colon and rectal prolapse repair, incontinence, pelvic floor reconstruction, sacral-colossal surgery, abdominal wall hernias, and thoracic wall hernias. To accomplish the necessary scaffolding, the mesh 100 can be made into a preformed design, a strap, a three-dimensional plug, or a flat plate, as needed for each condition to be corrected.

The surgical mesh 100 is a two bar warp knit construction. The web 100 is subjected to a number of forces under tension. These forces are generally along the X and Y axes X-X; Y-Y is applied to the web. Additionally, the force may be applied to the web along an intermediate vector between the X and Y axes. As shown, these forces may be exerted on the T and W axes T-T, W-W. The angle between X and W may be between 30 ° and 60 °, in a preferred embodiment 45 °. The angle between the Y and T axes is between 30 and 60, and in a preferred embodiment is 45. The mesh is isotropic when the angle between the X and W axes, and the Y and T axes is 45 °. It is achievable by those skilled in the art that angles can be similarly measured between the X and T axes and between the Y and W axes.

Referring to fig. 2, a mesh 100 is formed from a first braid 102 and a second braid 104. The first and second braids 102, 104 are long filaments that are guided along two opposite axes. For example, the braids 102, 104 may be guided along the X and Y or W and T axes. Fig. 1 and 2 show the first and second braids 102, 104 guided along the W and T axes. In one embodiment, the W and T axes are perpendicular, and the braids are equally spaced from each other along each axis. As shown in fig. 1 and 2, the first and second braids 102, 104 may form a square or diamond shape. In an alternative example, the first braid 102 may be spaced differently than the second braid 104, and the two braids may form a rectangle.

In addition to the first and second braids 102, 104, the third braid 106 and the fourth braid 108 are braided along the remaining two axes. In the illustrated embodiment, the third braid 106 is braided along the X-axis and the fourth braid 108 is braided along the Y-axis. In one embodiment, the third and

fourth braids

106, 108 may be perpendicular to each other. Again, the third and

fourth braids

106, 108 may form a square, diamond, or rectangular shape based on their positioning and spacing between adjacent braids on the same axis and on opposite axes.

The third and

fourth braids

106, 108 also intersect the first and second braids 102, 104 at or near the intersection 110 of the first and second braids 102, 104. Thus, in one embodiment, all four

braids

102, 104, 106, 108 are interwoven with at least one

other braid

102, 104, 106, 108 at an intersection 110. This interlacing adds strength to the surgical braid along the four axes X, Y, T, W and provides an isotropic pattern to the mesh 100 when the braids are properly spaced apart.

Fig. 3A-3E illustrate different weave examples that may be used to form mesh 100. A card chain for weaving pattern 200 is shown. Fig. 3A shows a weave pattern 200 representing a surgical mesh that can be made on a single needle bed due to the use of four guide bars (movement of which is shown in the same drawing). First yarn 202 creates a wale structure that provides stability to the fabric in the vertical direction. The two

yarns

204 and 206 of the wale are interlaced with the first yarn 202 creating an elastic and uniform structure. The last yarn 208 is a cross-machine direction stripe (course) that is repeatedly interlaced with yarn 202, increasing the strength of the fabric in the cross-machine direction.

Fig. 3B shows a second weave pattern 210. The first, second and

third filaments

202, 204, 206 perform the same structural purposes as previously described. However, the first, second and

third filaments

202, 204, 206 have slightly different bar patterns, with the fifth filament 212 (for the fourth of the pattern 210, but distinct from the fourth filament 208) being woven in a separate pattern. A card chain for weaving pattern 210 is shown.

Fig. 3C is a third weave pattern 214. The first, second and

third filaments

202, 204, 206 remain as previously described in fig. 3B, however, the sixth filament 216 (for the fourth of the pattern 214, but distinct from the fourth filament 208 and the fifth filament 212) is braided in a separate pattern. A card chain for a weave pattern 214 is shown.

Fig. 3D is a fourth weave pattern 218. The first, second and

third filaments

202, 204, 206 remain as previously described in fig. 3B, however, the seventh filament 220 (for the fourth of the pattern 218, but distinct from the fourth 208, fifth 212 and sixth 216 filaments) is woven in a separate pattern. A card chain for weaving pattern 218 is shown.

Fig. 3E is a fifth weave pattern 222. The first filament 202 is woven similarly to the first filament 202 in fig. 3A, while the second and

third filaments

204, 206 remain as previously described in fig. 3B. However, eighth filament 224 (used for the fourth of pattern 218, but distinct from fourth filament 208, fifth filament 212, sixth filament 216, and seventh filament 220) is braided in a separate pattern. A raspbook chain for weaving pattern 222 is shown.

Associating filaments (first to eighth 202, 204, 206, 208, 212, 216, 220, 224) with braids (first to fourth 102, 104, 106, 108), the first filament 202 forming the third braid 106. Second and

third filaments

204, 206 form first and second braids 102, 104, and fourth filament 208, fifth filament 212, sixth filament 216, seventh filament 220, and eighth filament 228 form fourth braid 108.

Each filament (first to eighth 202, 204, 206, 208, 212, 216, 220, 224) may be a monofilament or multifilament yarn comprising a single yarn. The diameter of the filaments may be between 60 μm and 180 μm. The diameters of the individual filaments (first to eighth 202, 204, 206, 208, 212, 216, 220, 224) may be the same or different, depending on the application. In embodiments, the filaments may be made of polypropylene (PP), polyester, or polyvinylidene fluoride (PVDF). The individual filaments may be formed from expanded polytetrafluoroethylene (ePTFE),

And/or other biocompatible synthetic material. In addition, certain sections of the filament may be coated on one or both sides, depending on the application.

In another embodiment, the filaments may be an interwoven combination of PP and absorbable polymer filaments such as lactide-glycolide copolyester/blend (PGLA), polylactic acid (PLLA), polydioxanone/polydioxanone (PDO or PDS), polycaprolactone, or poliglecaprone (polyglecaprone). This embodiment reduces the amount of PP left in the body. In this regard, one or more of the filaments (first through eighth 202, 204, 206, 208, 212, 216, 220, 224) may be PP, while the remaining filaments are absorbable polymers. Alternatively, the PP mesh graft may be coated on one or both sides or a portion of the graft mesh with a polymer (PLLA, PGLA) that may or may not be absorbable. Also, the PP mesh graft may be coated with titanium, silicone, or an antimicrobial agent.

In yet another embodiment, the PP mesh graft may be coated, either completely or only partially, on one or both sides, with a natural material such as collagen. The collagen may be equine, porcine or bovine, and may be absorbable or non-absorbable. In an alternative embodiment, the PP mesh may be fully or partially delaminated from the harvested material (i.e., human cadaver tissue or suitable non-human tissue). Collagen or harvested material is used to prevent erosion of tissue with which the mesh is in contact.

The coating of the filaments and/or mesh serves different purposes. The mesh is preferably implanted in the human body between two or more molecules. Surgical meshes transplanted into contact with organs or tissues can form adhesions or erosions. Certain of the above coatings reduce the likelihood of the mesh forming an adhesive or eroding the organ or tissue with which it is in contact. The corrosion problem is partly due to the fact that the cutting edge protects the roughness when the mesh is resized and can lead to tissue/organ damage over time. In addition, the texture of the PP mesh itself causes a foreign body response, so when it contacts an organ or is in a subcutaneous position, the rate of adhesion and/or erosion is greater. However, coating too much of the mesh surface reduces the ability of the mesh to incorporate into the surrounding tissue, and the Foreign Body Response (FBR) of the PP mesh results in fibrous tissue growth into the repair material and fixation of the actual mesh.

The use of absorbable coatings and filaments serves the purpose of increasing the structural stability of the mesh without increasing the overall PP load in the patient. The additional absorbable fiber/coating stiffens the mesh making implantation easier for the surgeon. The absorbency of the material is such that: over a period of time (days to months) after the mesh is implanted, the material is absorbed into the body. Now, this provides the mesh with the desired flexibility, which results in reduced corrosion and increased comfort to the patient, as reduced FBR results in less dense fibrous tissue.

Regardless of the filament material and/or coating, one or more of the filaments (first through eighth 202, 204, 206, 208, 212, 216, 220, 224) may be colored. The colored filaments may be spaced apart to form a band to improve visibility of the web 100 after the web is wetted by bodily fluids. The pitch of the colored filaments may be 1/2 inches to 2 inches. Additionally, a portion of the mesh may be colored to help center the mesh in the necessary location. For example, for placement of the mesh under the urethra, the central portion of the mesh (2-4 cm)²) May be colored. The coloring may beTo be an FDA approved color for PP, and in one embodiment, the filaments may be blue. In another embodiment, some materials and polishing of the filaments may result in greater light reflectivity. The higher reflectivity filaments may be interwoven to form the same band or center identifying pattern (when colored).

As discussed above, the diameter of the filaments may be between 60 μm and 180 μm. In one embodiment, the filaments are 80 μm 10%. The filament diameter corresponds to about 46 dTex. The filaments may be spun to have a tenacity of about 4.5 cN/dTex. Additionally, the filament may have an elongation at break once elongated. In one embodiment, the tenacity can be from 20% to 35% elongation. The thickness of the woven mesh may vary from 0.25 to 0.80 millimeters, and in one embodiment is 0.32mm 10%. The mesh may have about 30g/cm²Conventional weight of ± 8%. The specific gravity of the mesh may be between about 25 and 200g/cm²To change between. The tensile strength of the web is at least 16N/cm, and may further be 32N/cm. In one embodiment, the tensile strength is greater than 20N/cm while still maintaining 20% -35% elasticity.

Fig. 4-14 illustrate different examples of surgical straps made from the mesh of the present invention. The dimensions shown in the figures are in table 1 below. Fig. 4 shows a strap for urinary incontinence (male or female). Figure 5 shows a band for urinary incontinence in women with cystocele. Fig. 6 shows a strap for a female urinary incontinence and vaginal vault support. Figure 7 shows a man inguinal hernia repair, the same construct without a hole can be used for a woman inguinal repair. Figure 8 shows another men inguinal hernia repair. Figure 9 shows abdominal hernia repair. Fig. 10 shows a device for pelvic floor repair. Fig. 11 shows another device for pelvic floor repair. Figure 12 shows another strap for urinary incontinence and pelvic floor repair. Fig. 13 shows a strap for urinary incontinence. Fig. 14 shows another strap for urinary incontinence.

TABLE 1

While there have been shown and described and pointed out fundamental novel features of the invention as applied to a preferred embodiment thereof, it will be understood that various omissions and substitutions and changes in the form and details of the devices illustrated, and in their operation, may be made by those skilled in the art without departing from the spirit and scope of the invention. For example, it is expressly intended that all elements and/or steps which perform substantially the same function in substantially the same way to achieve the same results are within the scope of the invention. Substitutions of elements from one described embodiment to another are also fully intended and contemplated. It should also be understood that the drawings are not drawn to scale, but that they are merely conceptual in nature. Accordingly, it is intended that the invention be limited only by the scope of the appended claims.

Claims

1. A method for manufacturing a lightweight knitted surgical mesh on a four bar single bed machine comprising the steps of:

applying a first filament on a single needle bed machine;

knitting a first filament (202) by moving a first bar from a first row to an eighth row in the order of 2-1, 1-2, 2-1, and 1-2 in a first knitting pattern;

applying a second filament on the single needle bed machine;

knitting a second filament by moving a second bar in a second knitting pattern from a first row to an eighth row in the order of 2-1, 3-4, 5-6, 4-3, 3-4, and 3-4 (206);

applying a third filament (204) on the single bed machine;

knitting a third filament by moving a third bar from the first row to an eighth row in the order of 5-6, 4-3, 2-1, 3-4, 4-3, and 4-3 in a third knitting pattern;

applying a fourth filament on the single needle bed machine; and

the fourth filament (224) is knitted by moving the fourth bar from the first row to the eighth row in the order of 6-6, 1-1, 2-2, 1-1, 6-6, 1-1, 2-2, and 1-1 in a fourth knitting pattern.

2. The method of claim 1, wherein the first and second light sources are selected from the group consisting of a red light source, a green light source, and a blue light source,

wherein a first filament (202) is applied on the single needle bed machine in a first longitudinal row, the first filament forming a first series of partial loops at each of a plurality of transverse stripes for the surgical mesh;

wherein a third filament (204) is applied on the single bed machine along the first wale, the third filament forming a second series of complete stitches in a first adjacent wale adjacent to the first wale in an alternating manner and a third series of complete stitches with respect to the first wale along the plurality of transverse stripes in a second adjacent wale opposite to the first adjacent wale;

wherein the second filaments (206) form a series of complete loops in a second adjacent wale and the first adjacent wale along the plurality of transverse directions; and

wherein the fourth filament (224) is repeatedly interlaced with the first and second filaments in the transverse direction along the first longitudinal row.

3. The method of claim 1, wherein the second and third filaments are interlaced with the first filament to form a flexible and uniform structure to the surgical mesh.

4. The method of claim 1, wherein the first, second, third, and fourth filaments comprise at least one of a monofilament or a multifilament.

5. The method of claim 1, wherein the first, second, third, and fourth filaments comprise at least one of clear filaments and dyed filaments.

6. The method of claim 5, further comprising spacing dyed filaments apart¹/₂Inch to 2 inch steps.

7. The method of claim 1, wherein the first, second, thirdAnd the fourth filament comprises a coating comprising expanded polytetrafluoroethylene,

And a biocompatible synthetic material.

8. The method of claim 1, wherein the surgical mesh comprises a coating comprising at least one of a biocompatible synthetic material, titanium, silicone, an antimicrobial agent, absorbable collagen, non-absorbable collagen, and harvested material.

9. The method of claim 1, wherein the first, second, third, and fourth filaments comprise at least one of absorbable filaments and non-absorbable filaments.

10. The method of claim 1, further comprising the steps of:

forming a first braid, a second braid, a third braid, and a fourth braid from the first, second, third, and fourth filaments;

applying a first braid in parallel along a first axis;

applying a second braid in parallel along a second axis perpendicular to the first axis;

applying a third braid in parallel along a third axis offset from the first axis by about 30 ° to 60 °; and

a fourth braid is applied in parallel along a fourth axis perpendicular to the third axis.

11. The method of claim 10, further comprising the step of offsetting the third axis by 45 ° from the first axis.

12. The method of claim 10, further comprising the step of spacing the filaments of the first braid equidistantly.

13. The method of claim 10, further comprising the step of equidistantly spacing the filaments of at least two of the first braid, the second braid, the third braid, and the fourth braid.

14. The method of claim 10, further comprising the step of equidistantly spacing the first braid, the second braid, the third braid and the fourth braid to form an isotropic mesh.

15. The method of claim 1, wherein the surgical mesh comprises a tensile strength greater than 16N/cm.

16. The method of claim 15, wherein the tensile strength is greater than 20N/cm and the surgical mesh retains 20% -35% elasticity.

17. The method of claim 1, wherein the surgical mesh comprises about 25 to 200g/m²Specific gravity of (a).

18. The method of claim 1, wherein the first, second, third, and fourth filaments comprise a diameter of 46 dTex.

19. The method of claim 1, wherein the first, second, third, and fourth filaments comprise a diameter of 60 μ ι η to 180 μ ι η.

20. The method of claim 1, wherein the first, second, third, and fourth filaments comprise a tenacity of 20% to 35% elongation.

21. The method of claim 1, wherein the first, second, third, and fourth filaments comprise polypropylene, polyester, polyvinylidene fluoride, or an ethylene.