KR20200143496A - Method for making a lightweight quadriaxial surgical mesh - Google Patents

Abstract

A method of making a lightweight surgical mesh comprising applying a first set of filaments in a first wale direction and forming a first series of loops in each of a plurality of courses. Applying a second set of filaments in a first wale direction and a second series of loops in a first adjacent wale in a first wale direction along a plurality of courses and a second adjacent wale opposite the first adjacent wale. Forming 3 series of loops. Further, applying a third set of filaments in the first wale direction such that a second series of loops are formed in a second adjacent wale and a third series of loops are formed in the first adjacent wale along a plurality of courses. Further, applying a fourth set of filaments interlacing multiple times with the first set of filaments along the first wale direction.

Description

Manufacturing method of lightweight 4-axis surgical mesh {METHOD FOR MAKING A LIGHTWEIGHT QUADRIAXIAL SURGICAL MESH}

Cross-reference of related applications

This application is filed on June 27, 2008 with respect to Italian Patent Application No. MI2008A001186, filed under 35 U.S.C. CIP applicants of U.S. Application No. 12/454,308 filed May 15, 2009, claiming priority under §119 and U.S. Application No. 13/958,347 filed August 2, 2013, claiming priority. . The entirety of the above applications are incorporated herein by reference.

Field of invention

The present invention relates to a fibrous material and, in particular, to a surgical mesh of a knitted structure produced using a quadrilateral pattern forming an isotropic mesh.

Hernia treatment is one of the more common surgical procedures in which mesh fabric prosthesis can be used. These mesh fabric artifacts are used in other surgical procedures, including the treatment of anatomical defects in the abdominal wall, diaphragm, and chest wall, correction of defects in the urogenital system, and treatment of traumatic organs such as the spleen, liver or kidney.

Surgical artificial meshes can be implanted through open surgical procedures or laparoscopic procedures (ie, special tools are inserted into the surrounding tissue with narrow perforations made by the surgeon).

To form a mesh used in surgical treatment, a mesh fabric as well as a knitted woven fabric composed of various synthetic fibers can be used. It is preferable that the surgical mesh fabric exhibits specific properties and characteristics. In particular, a mesh suitable for surgical use must have sufficient tensile strength to prevent the mesh from tearing or tearing after implantation in a patient. In addition, the mesh must have a pore size that allows tissue to penetrate or “grow through” the mesh after the mesh is implanted into the patient. Also, the mesh should be constructed to maximize flexibility. The increased flexibility helps the mesh mimic the physiological properties of the body structure it replaces or reinforces. The added benefit of increased flexibility facilitates the insertion of mesh artifacts into the patient during surgical procedures.

One of the competing mesh design concepts is whether to use a heavyweight mesh with small pores or a lightweight mesh with large pores. Heavyweight mesh is designed to provide maximum strength for durable, sustained recovery of hernias. Heavyweight meshes are formed using thick fibers and tend to have smaller pores and very high tensile strength. However, heavyweight meshes can increase patient discomfort due to increased scar tissue formation.

The lightweight, large pore mesh is more tailored to the physiological needs of the body and allows for proper tissue integration. These meshes offer the possibility of forming a scar net instead of a hard scar plate, thus helping to avoid previously known mesh complications.

However, the lightweight mesh has other drawbacks. First, they typically have a lower minimum tensile strength, because of the smaller diameter and "open" weave of the filaments used. Also, this point is exacerbated by the fact that these meshes are formed anisotropically and the difference between tensile strengths in either direction of force can vary considerably. Another drawback of using a lightweight mesh is that the anisotropic nature of the mesh is that when placed under tension it tends to cause the mesh to twist or deform, making placement more difficult.

Furthermore, the surgical mesh fabric preferably has sufficient tensile strength to prevent the mesh from tearing or tearing after implantation in the patient. For augmentation and reinforcement of the existing body structure, the minimum tensile strength of the grafted mesh should be at least 16N/cm. The tensile strength required for meshes to be implanted to treat large abdominal hernias can be increased to 32 N/cm.

These and other objects and advantages of the present invention will become more apparent from the following detailed description and claims or may be learned by practicing the present invention.

The present invention is a light weight comprising a first axis, a second axis orthogonal to the first axis, a third axis approximately 30° to 60° offset from the first axis, and a fourth axis orthogonal to the third axis. It is a knitted surgical mesh. In addition, the mesh is 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 axis. It has a fourth weave running parallel to. In one implementation, the third axis is offset 45° from the first axis.

The first weave of the lightweight knitted surgical mesh may comprise a number of parallel filaments, wherein the filaments may be equidistantly or randomly spaced. Alternatively, at least two of the first, second, third, and fourth weaves comprise a plurality of parallel filaments, wherein the filaments of the weaves are spaced equidistantly or randomly. In one embodiment, the filaments of 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 may include at least one monofilament and multi-filament filaments. The filaments may have a diameter of 46 dTex and/or a diameter of 60 μm to 180 μm. In addition, the filaments may have a toughness of 20% to 35% elongation. The lightweight knitted surgical mesh formed of fibers may have a specific weight of approximately 25-200 g/m 2 and a tensile strength greater than 16 N/cm or 32 N/cm.

The first, second, third, and fourth weaves may include transparent filaments and dyed filaments. The spacing between the dyed filaments may be 1/2 inch to 2 inch to form a striped pattern. Furthermore, the mesh area can be dyed to increase visibility.

The filaments of the lightweight knitted surgical mesh may be made of polypropylene, polyester, or polyvinylidene fluoride. Furthermore, the filaments may be absorbable filaments and/or non-absorbable filaments. Further, the filaments at least one foamed (expanded) poly-tetrafluoroethylene may be coated with Teflon ^®, and the biocompatible composite material with a -tetrahydro ten fluoro / poly.

In addition, the mesh may be coated with at least one biocompatible synthetic material, titanium, silicone, antimicrobial agent, absorbable collagen, non-absorbable collagen, and harvested material.

The above and additional objects, features, and advantages of the present invention will become apparent upon consideration of the detailed description of the following specific implementation examples, especially in conjunction with the accompanying drawings, and the same reference numerals in the various drawings are used to indicate the same elements. Is used. here:
1 is a plan view of the surgical mesh of the present invention;
Figure 2 is a detailed view of the mesh of Figure 1;
3A, 3B, 3C, 3D, and 3E are weaving patterns of separate embodiments;
4 is a plan view of a sling (male or female) for incontinence made of the mesh of the present invention;
5 is a plan view of a woman's urinary incontinence sling related to bladder prolapse made of the mesh of the present invention;
6 is a plan view of a sling for supporting vaginal circumference and a woman's urinary incontinence made of the mesh of the present invention;
7 is a plan view of a male inguinal hernia treatment made of the mesh of the present invention;
8 is a plan view of another male inguinal hernia treatment made of the mesh of the present invention;
9 is a plan view of an abdominal wall hernia made of the mesh of the present invention;
10 is a plan view of a sling for pelvic floor treatment made of the mesh of the present invention;
11 is a plan view of another sling for pelvic floor treatment made of the mesh of the present invention;
12 is a plan view of another sling for urinary incontinence and pelvic floor treatment made of the mesh of the present invention;
13 is a plan view of a sling for urinary incontinence made of the mesh of the present invention;
14 is a plan view of another sling for urinary incontinence made of the mesh of the present invention.

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 incontinence or bowel incontinence caused by urethral hypermotor or endogenous sphincter defect (ISD). Furthermore, the surgical mesh 100 may be implanted to reinforce soft tissue defects. These include, but are not limited to, puourethral supports and bladder supports, urethral and vaginal prolapse treatment, pelvic organ prolapse, colon and rectal prolapse treatment, urinary incontinence, restoration of the pelvic floor, sacral-colposuspension, abdominal wall Includes hernias and chest wall defects. To achieve the necessary support, the mesh 100 can be made of a preformed design, sling, three-dimensional plug or flat sheet, as required for each alignment to be calibrated.

The surgical mesh 100 is a two bar warp knitting structure. The mesh 100 receives a lot of forces during tension. Typically, the forces are in the X and Y axes X-X; It is applied to the mesh along Y-Y. Furthermore, forces can be applied to the mesh along the intermediary vectors between the X and Y axes. As shown, forces can be applied in the T and W axes T-T, W-W. The angle between the X and W axes may be 30° to 60°, and in one embodiment, it may be 45°. The angle between the Y and T axes may be 30° to 60°, and in one embodiment, it may be 45°. If the angle between the X and W and Y and T axes is 45°, the mesh is isotropic. Those skilled in the art will recognize that the angles between the X and T axes and Y and W axes can also be measured similarly.

Referring to FIG. 2, the mesh 100 is formed from the first weave 102 and the second weave 104. The first and second weaves 102, 104 are elongated filaments directed along two opposite axes. For example, the weaves 102 and 104 may be oriented along the X and Y axes or the W and T axes. 1 and 2 show first and second weaves 102 and 104 oriented along the W and T axes. In one embodiment, the W and T axes are orthogonal and the weaves are spaced equidistant from each other along each axis. 1 and 2, the first and second weaves 102 and 104 may form a square or diamond shape. As an alternative example, the first weave 102 spacing may be different from the second weave 104 spacing, and the two weaves may form a rectangle.

In addition to the first and second weaves 102 and 104, the third weave 106 and the fourth weave 108 are woven along the remaining two axes. In the illustrated embodiment, the third weave 106 is woven along the X axis and the fourth weave 108 is woven along the Y axis. In one implementation, the third and fourth weaves 106 and 108 may be orthogonal to each other. Again, the third and fourth weaves 106 and 108 may form a square, diamond, or rectangular shape based on their position and the spacing between adjacent weaves on the same axis and on the opposite axis.

At or near the intersection 110 of the first and second weaves 102 and 104, the third and fourth weaves 106 and 108 also intersect the first and second weaves 102 and 104. Thus, in one implementation, all four weaves 102, 104, 106, 108 are interwoven with at least one other weave 102, 104, 106, 108 at the intersection point 110. This interwoven adds the strength of the surgical weave along the four axes X, Y, T, W, and provides a mesh 100 with an isotropic pattern when the weaves are properly spaced.

3A-3E illustrate different weaving examples that may be used to form the mesh 100. The pattern chain for the weaving pattern 200 is as shown. 3A shows a weaving pattern 200 representing a surgical mesh that can be fabricated on a single needle bar machine, with the use of four bars showing motion in the same figure. The first yarn 202 creates a wale structure that imparts stability to the fabric in the vertical direction. The two yarns 204 and 206 of the wale interlace with the first yarn 202 and create a resilient and uniform structure. The last yarn 208 is a deployment that interlaces repeatedly with the yarn 202, giving stability to the fabric in the transverse direction.

3B shows a second weaving pattern 210. The first, second, and third filaments 202, 204, 206 serve the same structural purpose 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 is The pattern 210, distinct from the fourth filament 208) is woven in a separate pattern. The pattern chain for the weaving pattern 210 is as shown.

3C is a third weaving pattern 214. The first, second, and third filaments 202, 204, and 206 are the same as discussed in FIG. 3B, but the sixth filament 216 (the fourth is the pattern 214, the fourth filament 208). ) And the fifth filament 212) are woven in a separate pattern. The pattern chain for the weaving pattern 214 is as shown.

3D is a fourth weaving pattern 218. The first, second, and third filaments 202, 204, 206 are the same as previously discussed in FIG. 3B, but the seventh filament 220 (the fourth is a pattern 218), and the fourth filament 208 ), the fifth filament 212, and the sixth filament 216 are woven in a separate pattern. The pattern chain for the weaving pattern 218 is as shown.

3E is a fifth weaving pattern 222. The first filament 202 is woven similarly to the first filament 202 of FIG. 3A and the second and third filaments 204 and 206 are the same as previously discussed in FIG. 3B. However, the eighth filament 224 (the fourth is a pattern 218, distinguished from the fourth filament 208, the fifth filament 212, the sixth filament 216 and the seventh filament 220) is separate Is woven in a pattern of. The pattern chain for the weaving pattern 222 is as shown.

With respect to the filaments (first to eighth, 202, 204, 206, 208, 212, 216, 220, 224) for weaves (first to fourth, 102, 104, 106, 108), the first The filament 202 forms a third weave 106. The second and third filaments 204 and 206 form the first and second weaves 102 and 104, and the fourth filament 208, the fifth filament 212, the sixth filament 216, The 7 filaments 220, and the eighth filaments 228 form the fourth weave 108.

Each filament (first through eighth, 202, 204, 206, 208, 212, 216, 220, 224) may be a monofilament comprising a single stranded yarn or a multi-filament yarn. The diameter of the filaments may be 60 μm to 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 one embodiment, the filaments may be made from polypropylene (PP), polyester, or polyvinylidene fluoride (PVDF). The individual filaments are foamed it may be coated with ethylene (ePTFE), Teflon ^®, and / or other biocompatible synthetic material tetrafluoro-X / poly tetrafluoroethylene. Furthermore, depending on the application, certain sections of the filaments may be coated on one or both sides.

In another embodiment, the filaments are PP and absorbent polymer filaments such as polyglactin (PGLA), poly-l-lactide acid (PLLA), polydioxanone/poly-p-dioxanone (PDO or PDS), poly It may be an interwoven combination of caprolactone or polyglecaprone. This embodiment reduces the amount of PP remaining 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 and the remaining filaments are absorbent polymer. Alternatively, the PP mesh implant may be coated on one or both sides or a portion of the implant mesh with an absorbent or non-absorbent polymer (PLLA, PGLA). Additionally, the PP mesh implant can be coated with titanium, silicone, or antimicrobial agents.

In another embodiment, the PP mesh implant may be coated with a natural material such as collagen, all or only partially, on one or both sides. Collagen can be horse, pig, or bovine, and is absorbable or non-absorbable. In alternative embodiments, the PP mesh may be layered, in whole or in part, with harvesting material (ie, human specimen tissue, or suitable non-human tissue). The use of collagen or harvesting material prevents corrosion of the tissue in contact with the mesh.

Coating of the filaments and/or mesh serves another purpose. Transplantation of the mesh into the body is best between two or more muscles. Surgical mesh implanted in contact with organs or tissues can form adhesions or erosions. Certain coatings such as these reduce the likelihood that the mesh will corrode or form adhesions to the organs or tissues it comes into contact with. Part of the corrosion problem is that when cutting the mesh to size, the cut edges remain rough and can cause tissue/organ damage over time. In addition, the texture of the PP mesh itself causes a foreign body reaction, so when it is in contact with the organ or in a subcutaneous position, the rate of adhesion and/or corrosion is faster. However, coating too much of the mesh surface can reduce the ability of the mesh to integrate into the surrounding tissue, and it is the foreign body reaction (FBR) of the PP mesh that causes the growth and actual mesh fixation of the fibrous tissue into the artificial material.

The use of absorbent coatings and filaments serves the purpose of increasing the structural stability of the mesh without adding a total load of PP to the patient. Additional absorbent fibers/coatings stiffen the mesh to facilitate implantation by the surgeon. The absorption of a material is that the material is absorbed into the body within a set period (ie, days to months) after the mesh is implanted. This imparts the desired elasticity to the mesh, which can lead to reduced corrosiveness and increased patient comfort, due to the reduced FBR resulting 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 stripes to improve visibility of the mesh 100 after the mesh is wetted with body fluid. The spacing of the colored filaments may fall by 1/2 inch to 2 inch. Additionally, some of the meshes can be colored to aid in positioning the center of the mesh if necessary. For example, when placing a mesh under the urethra, the center of the mesh (2-4 cm ² ) may be colored. The coloring may be in an FDA approved color for PP, and in one embodiment, the filaments may be colored blue. In other embodiments, the specific material and finish of the filaments can lead to greater light reflection. The larger reflective filaments can be interwoven to form the same stripe or center identification pattern according to coloring.

As described above, the diameter of the filaments may be 60 μm to 180 μm. In one embodiment, the filaments are 80 μm±10%. This filament diameter corresponds to approximately 46 dTex. The filaments can be spun to have a toughness of approximately 4.5 cN/dTex. Furthermore, the filament may have an elongation at break during stretching. In one embodiment, the toughness may be between 20% and 35% elongation. The thickness of the woven mesh may be 0.25-0.80 mm, and in one embodiment may be 0.32 mm±10%. Customarily the mesh can have an approximate 30 g/m ² ±8% weight. The specific weight of the mesh may be approximately 25-200 g/m ² . The tensile strength of the mesh is at least 16 N/cm, and may further be 32 N/cm. In one embodiment, the tensile strength is greater than 20 N/cm and still has a modulus of elasticity of 20%-35%.

4-14 show different examples of a surgical sling made of the mesh of the present invention. The dimensions indicated in the drawings are shown in Table 1 below. 4 shows a sling for incontinence (male or female). 5 shows a sling for urinary incontinence in women involved in bladder prolapse. Figure 6 shows a vaginal circumference support and a female's incontinence sling. 7 shows the treatment of a male inguinal hernia, and the same configuration without a hole is for treating a female inguinal region. Figure 8 shows another male inguinal hernia treatment. 9 shows abdominal wall hernia treatment. 10 shows a device for treatment of the pelvic floor. 11 shows another device for pelvic floor treatment. 12 shows another sling for urinary incontinence and pelvic floor treatment. 13 shows a sling for urinary incontinence. 14 shows another sling for incontinence.

[Table 1]

Key novel features of the present invention applied as preferred embodiments have been shown, described and mentioned, in the shape and details of the illustrated device, and in the operation thereof, various omissions, substitutions, and modifications without departing from the nature and scope of the present invention. It will be appreciated that this can be done by one of ordinary skill in the art. For example, it is expressly intended that all combinations of elements and/or steps that perform substantially the same function, in substantially the same way, are within the scope of the present invention in order to achieve the same results as the present invention. Substitution of elements from one described embodiment to another is also fully intended and contemplated. In addition, it will be understood that the drawings are not necessarily drawn to scale and they are merely conceptual in nature. Accordingly, the invention will be limited only as indicated by the scope of the appended claims below.

Claims (19)

Applying a first filament (202) on a single needle bar machine;
The first bar of the first weaving pattern from the first line to the eighth line in the order of 2-1, 1-2, 2-1, 1-2, 2-1, 1-2, 2-1, and 1-2 Moving, weaving the first filament 202;
Applying a second filament (206) on a single needle bar machine;
The second bar of the second weaving pattern is from the first line to the eighth line in the order of 2-1, 3-4, 3-4, 3-4, 5-6, 4-3, 3-4, and 3-4. Moving, weaving the second filament 206;
Applying a third filament (204) on a single needle bar machine;
3rd bar of the 3rd weaving pattern from the 1st line to the 8th line in the order of 5-6, 4-3, 4-3, 4-3, 2-1, 3-4, 4-3 and 4-3 Moving, weaving the third filament 204;
Applying a fourth filament (224) on a single needle bar machine; And
The fourth bar of the fourth weaving pattern from the first line to the eighth line in the order of 6-6, 1-1, 2-2, 1-1, 6-6, 1-1, 2-2, and 1-1. Including; moving, weaving the fourth filament 224,
The pattern chain of the weaving pattern is shown in Figure 3e below,
A method of making a lightweight knitted surgical mesh on a single needle bar machine with 4 bars.
[Figure 3e]

The method of claim 1,
A first filament 202 is applied to a first wale on a single needle bar machine, the first filament forming a first series of loops in each of the plurality of courses for the surgical mesh,
A third filament 204 is applied along the first wale on a single needle bar machine, and the third filament is applied along a plurality of courses relative to the first wale, and the second series in the first adjacent wale relative to the first wale. Alternately forming a third series of loops in the loops and the second adjacent wales opposite the first adjacent wales,
The second filaments 206 form a series of loops in the second adjacent wale and the first adjacent wale along a number of courses, and,
The fourth filament 224 is repeatedly interlaced with the first filament and the second filament in the course direction along the first wale,
A method of making a lightweight knitted surgical mesh on a single needle bar machine with 4 bars.
The method of claim 1,
The first, second, third and fourth filaments comprise at least one monofilaments and multi-filaments,
A method of making a lightweight knitted surgical mesh on a single needle bar machine with 4 bars.
The method of claim 1,
The first, second, third and fourth filaments comprise a diameter of 46 dTex,
A method of making a lightweight knitted surgical mesh on a single needle bar machine with 4 bars.
The method of claim 1,
The first, second, third and fourth filaments comprise a diameter of 60 μm to 180 μm,
A method of making a lightweight knitted surgical mesh on a single needle bar machine with 4 bars.
The method of claim 1,
The first, second, third and fourth filaments comprise a tenacity of 20% to 35% elongation,
Manufacturing method of lightweight knitted surgical mesh on a single needle bar machine with 4 bars
The method of claim 1,
The surgical mesh comprises a specific weight of 25 to 200 g/m 2,
A method of making a lightweight knitted surgical mesh on a single needle bar machine with 4 bars.
The method of claim 1,
The first, second, third and fourth filaments comprise at least one transparent filaments and dyed filaments,
A method of making a lightweight knitted surgical mesh on a single needle bar machine with 4 bars.
The method of claim 8,
Further comprising the step of disposing the dyed filaments at 1/2 inch to 2 inch intervals,
A method of making a lightweight knitted surgical mesh on a single needle bar machine with 4 bars.
The method of claim 1,
The first, second, third and fourth filaments comprise one of polypropylene, polyester and polyvinylidene fluoride,
A method of making a lightweight knitted surgical mesh on a single needle bar machine with 4 bars.
The method of claim 1,
The first, second, third and fourth filaments at least one foamed (expanded) poly-containing coating comprising ethylene, Teflon ^®, and the biocompatible composite material with a tetra-fluoro-tetrafluoro X / Poly ,
A method of making a lightweight knitted surgical mesh on a single needle bar machine with 4 bars.
The method of claim 1,
The surgical mesh comprises a coating comprising at least one biocompatible synthetic material, titanium, silicone, antimicrobial agent, absorbable collagen, non-absorbable collagen, and harvesting material,
A method of making a lightweight knitted surgical mesh on a single needle bar machine with 4 bars.
The method of claim 1,
The first, second, third and fourth filaments comprise at least one absorbent filaments and non-absorbent filaments,
A method of making a lightweight knitted surgical mesh on a single needle bar machine with 4 bars.
The method of claim 1,
Forming a first weave, a second weave, a third weave, and a fourth weave from the first, second, third and fourth sets of filaments
Applying a first weave parallel to the first axis;
Applying a second weave parallel to the second axis orthogonal to the first axis;
Applying a third weave that is parallel along a third axis 30° to 60° offset from the first axis; And
Further comprising applying a fourth weave parallel to a fourth axis orthogonal to the third axis,
A method of making a lightweight knitted surgical mesh on a single needle bar machine with 4 bars.
The method of claim 14,
Further comprising the step of offsetting the third axis 45° from the first axis,
A method of making a lightweight knitted surgical mesh on a single needle bar machine with 4 bars.
The method of claim 14,
Further comprising the step of disposing the filaments of the first weave equidistantly,
A method of making a lightweight knitted surgical mesh on a single needle bar machine with 4 bars.
The method of claim 14,
Further comprising the step of disposing two or more filaments of the first weave, the second weave, the third weave, and the fourth weave at equidistant distances,
A method of making a lightweight knitted surgical mesh on a single needle bar machine with 4 bars.
The method of claim 14,
Further comprising the step of equidistantly disposing the first weave, the second weave, the third weave, and the fourth weave to form an isotropic mesh,
A method of making a lightweight knitted surgical mesh on a single needle bar machine with 4 bars.
The method of claim 1,
The surgical mesh comprises a tensile strength greater than 16 N/cm,
A method of making a lightweight knitted surgical mesh on a single needle bar machine with 4 bars.

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