RU2675316C2 - Method for making lightweight quadriaxial surgical mesh - Google Patents

Abstract

FIELD: textile.SUBSTANCE: method for making a lightweight surgical mesh, comprising steps of applying a first set of filaments in a first wale direction and forming a first set of loops at each of a plurality of courses. Applying a second set of filaments in the first wale direction and forming a second set of loops at a first adjacent wale to the first wale direction, and a third set of loops at a second adjacent wale opposite the first adjacent wale along the plurality of courses. Further, applying a third set of filaments in the first wale direction so that the second set of loops are formed at the second adjacent wale and the third set of loops are formed at first adjacent wale along the plurality of courses. Additionally, applying a fourth set of filaments that interlace repeatedly with the first set of filaments along the first wale direction.EFFECT: 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.15 cl, 18 dwg

Description

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to US application No. 13/958347, filed August 2, 2013, which is a partial continuation of US application No. 12/454308, filed May 15, 2009, which also claims priority in accordance with paragraph 119 of section 35 of the Code of Laws US patent application Italy No. MI2008A001186, filed June 27, 2008. The contents of the above applications are incorporated into this description by reference.

FIELD OF TECHNOLOGY

This invention relates to a textile material, and in particular, to a surgical mesh of a knitted structure made using a four-sided pattern forming an isotropic mesh.

BACKGROUND

Gernioplasty is one of the most common surgical operations in which a mesh prosthesis can be used. Such mesh prostheses are also used in other surgical procedures, including surgical repair of anatomical defects in the abdominal wall, diaphragm and chest wall, correction of defects in the genitourinary system, and surgical repair of traumatic organ injuries, such as the spleen, liver or kidney.

Prosthetic surgical nets can be implanted by open surgery or by laparoscopic procedures (i.e. the introduction of special devices into narrow incisions made by the surgeon in the surrounding tissue).

Mesh fabrics, similar to knitted and woven fabrics made from various synthetic fibers, can be used to form a mesh used in reconstructive surgery. Surgical mesh tissue should preferably have certain properties and characteristics. In particular, a mesh suitable for surgical applications should have a tensile strength sufficient to prevent the mesh from breaking or breaking after implantation in the patient’s body. The mesh should also have a pore size that allows tissue to penetrate into the mesh or “germinate” through the mesh after it is implanted into the patient’s body. Additionally, the mesh should be designed to provide maximum flexibility. Increased flexibility allows the grid to repeat the physiological features of the body structure, which it replaces or strengthens. An additional advantage of increased flexibility is the introduction of a mesh prosthesis into the patient’s body during surgery.

There are opposing mesh design concepts, one of which is to use a heavy mesh with smaller pores or a lightweight mesh with larger pores. Heavy nets are designed to provide maximum strength for long-term and reliable hernia repair. Heavy nets formed using thick fibers usually have smaller pores and very high tensile strength. However, heavy nets can cause increased patient discomfort due to increased scar tissue formation.

Lightweight grids with larger pores are better suited to the physiological needs of the body and allow proper tissue integration. These nets provide the possibility of scar formation instead of a hard scar plate and, therefore, help to prevent known complications associated with the mesh.

However, lightweight nets have other disadvantages. Firstly, they usually have a lower minimum tensile strength due to the smaller diameter of the thread used and the "open" weave. This is also complicated by the fact that such nets form anisotropic, and the difference between the tensile strength in any of the directions of force can differ significantly. Another disadvantage of using lightweight grids is that the anisotropic structure of the grid causes twisting or deformation of the grid when subjected to stress, which complicates the placement.

Also preferably, the surgical mesh tissue should have a tensile strength sufficient to prevent tearing or tearing of the mesh after implantation in the patient’s body. The minimum tensile strength for nets implanted to build up and strengthen the existing body structure should be at least 16 N / cm. The tensile strength required for nets implanted to repair large hernias of the abdominal wall can reach 32 N / cm.

These and other objects and advantages of the invention will be fully understood from the following description and claims, or may be learned by realizing the invention.

SUMMARY OF THE INVENTION

The invention is a lightweight knitted surgical mesh comprising a first axis, a second axis perpendicular to the first axis, a third axis offset from about 30 ° to 60 ° from the first axis, and a fourth axis perpendicular to the third axis. The mesh also includes 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 a lightweight knitted surgical mesh may contain many parallel threads, and the threads can be located at equal or arbitrary distance from each other. In another embodiment, at least two first, second, third and fourth weaves comprise a plurality of parallel threads, the threads for weaving being located at equal or arbitrary distance from each other. In one embodiment, the yarns for the first weave, the second weave, the third weave and the fourth weave are located at an equal distance from the isotropic mesh.

The first, second, third and fourth weaves may contain yarns that are single-fiber or multi-fiber. The filaments may have a linear density of 46 dtex and / or a diameter of 60 μm to 180 μm. The tensile elongation of the threads can also be from 20% to 35%. A lightweight knitted surgical mesh made of fibers can have a specific gravity of about 25 to 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 contain pure yarns and dyed yarns. The distance between the dyed yarns can be from 1/2 inch (1.27 cm) to 2 inches (5.08 cm) to form a strip pattern. Also, a portion of the mesh can be painted to improve visibility.

The threads of a lightweight knitted surgical mesh can be made of polypropylene, polyester or polyvinylidene fluoride. Also, the thread may be absorbable threads and / or non-absorbable threads. Additionally, the yarns may be coated with expanded polytetrafluoroethylene / polytetrafluoroethylene, Teflon® or a biocompatible synthetic material.

The mesh can also be coated with a biocompatible synthetic material, titanium, silicone, antimicrobial agents, absorbable collagen, non-absorbable collagen or graft material.

BRIEF DESCRIPTION OF THE DRAWINGS

The previously described and other objects, characteristic features and advantages of the present invention will be clear after reading the following detailed description of its particular implementation, in particular in combination with the accompanying drawings, in which the same reference numerals denote the same components in different figures, and in which:

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

In FIG. 2 is a detailed view of the mesh of FIG. one;

In FIG. 3A, 3B, 3C, 3D and 3E illustrate weaving webs of individual examples;

In FIG. 4 is a top view of a dressing for the treatment of urinary incontinence (in men or women) made from the net of the present invention;

In FIG. 5 is a top view of a dressing for treating female urinary incontinence associated with a bladder hernia made from a mesh of the present invention;

In FIG. 6 is a top view of a dressing for treating urinary incontinence in women and for maintaining a vaginal fornix made from the mesh of the present invention;

In FIG. 7 is a plan view of an inguinal hernia repair in men made from the mesh of the present invention;

In FIG. 8 is a top view of yet another plastic inguinal hernia in men made from the mesh of the present invention;

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

In FIG. 10 is a plan view of a pelvic floor dressing made from the mesh of the present invention;

In FIG. 11 is a top view of yet another pelvic floor dressing made from the mesh of the present invention;

In FIG. 12 is a top view of yet another dressing for treating urinary incontinence and restoring a pelvic floor made from the mesh of the present invention;

In FIG. 13 is a top view of a dressing for treating urinary incontinence made from a mesh of the present invention; and

In FIG. 14 is a top view of yet another dressing for treating urinary incontinence made from the net of the present invention;

DETAILED DESCRIPTION OF THE INVENTION

As shown in FIG. 1, a surgical mesh 100 of the present invention is depicted. Surgical mesh 100 may be surgically implanted in a patient’s body to treat urinary or fecal incontinence resulting from urethral hypermotility or internal sphincter insufficiency (ISD). Also, surgical mesh 100 may be implanted to strengthen soft tissue defects. This includes, without limitation, maintaining the pubourethral region and the bladder, restoring the prolapse of the urethra and vagina, lowering the pelvic organs, restoring the prolapse of the colon and rectum, incontinence, reconstructing the pelvic floor by surgery, sacral colposuspension, hernias of the abdominal wall and defects of the chest wall. To provide the required support, the grid 100 can be made having a predetermined shape, in the form of dressings, three-dimensional tampons or flat sheets, depending on the requirement to correct each disease.

Surgical mesh 100 has a warp knitted structure obtained by two combs. The grid 100 is exposed to numerous forces and stresses. Forces are usually applied to the grid along the axes X and Y, X-X and Y-Y. In addition, forces can be applied to the grid along auxiliary vectors between the X and Y axes. In accordance with the image, forces can be applied in the 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 may be between 30 ° and 60 °, and in one preferred embodiment, 45 °. If the angles between the axes X and W, and Y and T are 45 °, then the grid is isotropic. One skilled in the art will understand that the angle can likewise be measured between the axes X and T, and Y and W.

As shown in FIG. 2, the mesh 100 is made of a first weave 102 and a second weave 104. The first and second weaves 102, 104 are long threads directed along two opposite axes. For example, weaves 102, 104 may be directed along the axes X and Y, or W and T. In FIG. 1 and 2 show the first and second weaves 102, 104 facing along the axes W and T. In one embodiment, the axes W and T are perpendicular, and the weaves are located at equal distance from each other along each axis. As shown in FIG. 1 and 2, the first and second weaves 102, 104 may form a square or diamond shape. In alternative examples, the distance of removal of the first weave 102 may differ from the distance of removal of the second weave 104, and two weaves may form rectangles.

In addition to the first and second weaves 102, 104, the third weave 106 and the fourth weave 108 are weaved along the remaining two axes. In the illustrated embodiment, the third weave 106 is braided along the X axis, and the fourth weave 108 is braided along the Y axis. In one embodiment, the third and fourth weave 106, 108 may be perpendicular to each other. Similarly, the third and fourth weaves 106, 108 can form square, rhomboid or rectangular shapes based on their location and the distance of removal between adjacent weaves on the same axis and the opposite axis.

At the intersection points 110 of the first and second weaves 102, 104, or adjacent to them, the third and fourth weaves 106, 108 also intersect the first and second weaves 102, 104. Thus, in one embodiment, all four weaves 102, 104, 106, 108 are interwoven with at least one other weave 102, 104, 106, 108 at intersection points 110. This weave increases the strength of the surgical weave along the four axes X, Y, T, W, and forms an isotropic mesh pattern 100 in which the weaves are spaced appropriately.

In FIG. 3A-3E depict various examples of weaving that can be used to form a mesh 100. The distribution chain for weaving 200 is as shown. In FIG. 3A shows a weaving 200, corresponding to a surgical mesh, which can be made on the same path through the use of four rods, the movement of which is depicted in the same figure. The first yarn 202 forms a loop stitch structure that provides vertical stability to the fabric. Two yarns of a loop post, 204 and 206, are intertwined with the first yarn 202 to form an elastic and uniform structure. The last yarn 208 is a looped row, which by repeatedly weaving with yarn 202 increases the stability of the fabric in the transverse direction.

In FIG. 3B depicts a second weaving 210. The first, second, and third yarns 202, 204, 206 perform the same structural functions as previously described. However, the first, second, and third threads 202, 204, 206 have slightly different rod configurations, and the fifth thread 212 (fourth for weaving 210, but different from fourth thread 208) is woven with a separate weave. The distribution chain for weaving 210 is as shown.

In FIG. 3C depicts a third weaving 214. The first, second, and third threads 202, 204, 206 remain the same as previously described in FIG. 3B, however, the sixth yarn 216 (the fourth yarn 214, however different from the fourth yarn 208 and the fifth yarn 212) is woven with a separate weave. The distribution chain for weaving 214 corresponds to that shown.

In FIG. The fourth weaving 218 is shown in 3D. The first, second and third threads 202, 204, 206 remain the same as described previously in FIG. 3B, however, the seventh thread 220 (fourth for weaving 218, but different from fourth thread 208, fifth thread 212 and sixth thread 216) is woven with a separate weave. The distribution chain for weaving 218 corresponds to that shown.

In FIG. 3E depicts a fifth weaving 222. The first thread 202 is woven like the first thread 202 in FIG. 3A, and the second and third threads 204, 206 remain the same as previously described in FIG. 3B. However, the eighth thread 224 (fourth for weaving 218, however different from fourth thread 208, fifth thread 212, sixth thread 216 and seventh thread 220) is woven with a separate weave. The distribution chain for weaving 222 corresponds to the one shown.

Correlating the threads (from the first to the eighth 202, 204, 206, 208, 212, 216, 220, 224) with the weaves (from the first to the fourth, 102, 104, 106, 108), the first thread 202 forms the third weave 106. The second and the third thread 204, 206 form the first and second weaves 102, 104, and the fourth thread 208, the fifth thread 212, the sixth thread 216, the seventh thread 220 and the eighth thread 228 form the fourth weave 108.

Each thread (from the first to the eighth 202, 204, 206, 208, 212, 216, 220, 224) may be a single-fiber thread containing one thread of yarn, or a multi-fiber thread containing many threads of yarn. The diameter of the filaments may be between 60 μm and 180 μm. The diameter of individual threads (from the first to the eighth 202, 204, 206, 208, 212, 216, 220, 224) may not differ or differ depending on use. In an embodiment, the filaments may be made of polypropylene (PP), polyester or polyvinylidene fluoride (PVDF). Individual threads may be coated with expanded polytetrafluoroethylene / polytetrafluoroethylene (ePTFE), Teflon (Teflon®) and / or other biocompatible synthetic material. Also, some sections of the threads may be coated on one or both sides depending on the application.

In yet another embodiment, the filaments can be an interwoven combination of polypropylene (PP) and an absorbable polymer filament, such as polyglactin (PGLA), poly-L-lactic acid (PLLA), polydioxanone / poly-P-dioxanone (PDO or PDS), polycaprolactone or polyglecapron. In this embodiment, the amount of polypropylene (PP) remaining in the body is reduced. For this, one or more threads (from the first to the eighth 202, 204, 206, 208, 212, 216, 220, 224) can be made of polypropylene (PP), and the rest of the thread is made of absorbable polymer. Alternatively, the polypropylene implant mesh may be coated with an absorbable or non-absorbable polymer (PLLA, PGLA) on one or both sides, or in the area of the implant mesh. Also, the polypropylene mesh implant may be coated with titanium, silicone or antimicrobial agents.

In another embodiment, the polypropylene implant mesh may be coated on one or both sides, completely or only in the area, with a natural material such as collagen. Collagen can be horse, pork or bovine, as well as absorbable or non-absorbable. In an alternative embodiment, the polypropylene mesh may be completely or interrupted by transplant material (i.e., human corpse tissue or a suitable non-human tissue). The use of collagen or graft material prevents the erosion of the tissue that the mesh contacts.

Coating threads and / or nets performs various functions. The mesh is implanted in the human body, preferably between two or more muscles. Implanted surgical nets in contact with organs or tissues can lead to fusion or erosion. The previously defined coatings reduce the likelihood of the network forming splices or erosion of the organs or tissue with which it is in contact. Part of the problem associated with erosion is that when the mesh is cut to the required size, the edges of the cut remain stiff and can cause tissue / organ damage over time. Also, the texture of the polypropylene mesh causes a reaction to foreign bodies, and, therefore, when it comes into contact with organs or when under the skin, the speed of adhesion and / or erosion increases. However, coating a mesh surface that is too large can reduce the mesh's ability to integrate into the surrounding tissue, it is the reaction to foreign bodies (FBR) of the polypropylene mesh that causes the fibrous tissue to grow into the prosthetic material and the mesh is actually fixed.

The use of absorbable coatings and threads performs the function of increasing the structural stability of the mesh without increasing the total mass of polypropylene (PP) in the patient's body. Additional absorbable fibers / coatings strengthen the mesh and facilitate the surgeon's implantation process. The absorbability of the material ensures the dissolution of the material in the body for a certain period of time (i.e., from days to months) after implantation of the mesh. This provides the required flexibility of the mesh, which can reduce erosion and increase patient comfort due to a reduced response to foreign bodies (FBR), which results in less durable fibrous tissue.

дюйма (1,27 см) до 2 дюймов (5,08 см). Дополнительно, участок сетки может быть окрашен для способствования расположению центра сетки в требуемом месте. Например, для расположения сетки под уретрой, центральный участок (2-4 см²) сетки может быть окрашен. Красящее вещество может являться одобренным управлением по контролю за продуктами и лекарствами FDA красящим веществом для полипропилена (РР), а в одном варианте реализации нити могут быть окрашены в голубой цвет. В еще одном варианте реализации определенные материалы и покрытия нитей могут обуславливать более высокий коэффициент отражения света. Нити с более высоким коэффициентом отражения света могут быть сплетены с образованием полосы или переплетения, идентифицирующего центр, аналогично красящему веществу.Regardless of the material and / or coating of the thread, one or more threads (from the first to the eighth 202, 204, 206, 208, 212, 216, 220, 224) can be dyed. The dyed yarns can be separated from each other with the formation of bands to improve the visibility of the grid 100 after it gets wet from body fluid. The distance to remove the dyed yarn may be from

inches (1.27 cm) to 2 inches (5.08 cm). Additionally, the grid portion may be colored to facilitate the location of the center of the grid at the desired location. For example, to position the mesh under the urethra, the central portion (2-4 cm ² ) of the mesh may be colored. The colorant may be an approved FDA Food and Drug Administration dyeing agent for polypropylene (PP), and in one embodiment, the filaments may be dyed blue. In yet another embodiment, certain yarn materials and coatings may result in a higher light reflectance. Filaments with a higher light reflectance can be woven to form a strip or weave that identifies the center, similar to a dye.

As described previously, the diameter of the threads may be between 60 μm and 180 μm. In one embodiment, the diameter of the thread is 80 μm ± 10%. This filament diameter corresponds to approximately 46 dtex. A filament may be formed with a specific strength of approximately 4.5 cN / dtex. Also, the thread may have elongation at break after stretching. In one embodiment, the tensile elongation may be from 20% to 35%. The thickness of the woven mesh can vary from 0.25 to 0.80 millimeters, and in one embodiment it is 0.32 mm ± 10%. Typically, the density of the mesh may be approximately 30 g / m ² ± 8%. The specific gravity of the mesh may vary between approximately 25 and 200 g / m ² . The tensile strength of the mesh is at least 16 N / cm, and may be 32 N / cm. In one embodiment, the tensile strength exceeds 20 N / cm while maintaining 20% to 35% flexibility.

In FIG. 4-14 illustrate various examples of surgical dressings made from the mesh of the present invention. The dimensions shown in the figures are shown below in table 1. In FIG. 4 shows a bandage for the treatment of urinary incontinence (in men or women). In FIG. 5 shows a dressing for women urinary incontinence associated with a hernia of the bladder. In FIG. 6 shows a dressing for treating urinary incontinence in women and for maintaining the vaginal fornix. In FIG. Figure 7 shows the plastic inguinal hernia in men, and the same configuration without a hole is for plastic inguinal hernia in women. In FIG. Figure 8 shows another inguinal hernia repair in men. In FIG. 9 shows hernioplasty of the abdominal wall. In FIG. 10 shows a device for restoring the pelvic floor. In FIG. 11 shows another device for restoring the pelvic floor. In FIG. 12 shows another dressing for the treatment of urinary incontinence and restoration of the pelvic floor. In FIG. 13 shows a dressing for the treatment of urinary incontinence. In FIG. 14 shows another dressing for the treatment of urinary incontinence.

Despite the fact that the fundamental characteristic features of the invention were depicted, described and indicated as applied to its preferred embodiment, it should be understood that various omissions, replacements and changes in the form, details and functionality of the illustrated devices can be made by those skilled in the art without deviations from the essence and scope of the invention. For example, it is expressly assumed that all combinations of these elements and / or steps that perform essentially the same function in essentially the same way to achieve the same result are within the scope of the invention. Replacements of elements from one described embodiment to another are also fully included and taken into account. It should also be understood that the drawings are not necessarily scaled, but are essentially conceptual. Therefore, it is intended that the invention be limited only by the scope of the appended claims.

Claims (27)

1. A method of manufacturing a lightweight knitted surgical mesh, comprising the steps of: the location of the first set of threads in the first stitch columns on the same path, with each of the first set of threads forming the first sequence of loops on each of the many loop rows for the surgical mesh; the location of the second set of threads along the first loop posts on the same texture, with each of the second set of threads alternating forming a second sequence of loops on the first adjacent loop posts with the first loop posts and a third sequence of loops on the second adjacent loop posts opposite the first adjacent loop posts in relation to to the indicated first stitching columns along the specified set of stitch rows; the location of the third set of threads along the first loop strings on the same path, and the complementary third loop sequence is formed on the second adjacent loop stitches, and the second complementary loop sequence is formed on the first adjacent loop stitches along the specified set of loop rows; and the location of the fourth set of threads, repeatedly intertwined with the first set of threads in the direction of the loop rows, along the first loop columns. 2. The method according to p. 1, in which: the first set of threads ensures the stability of the surgical mesh in the first loop stakes; the second and third sets of threads are intertwined with the first set of threads with the formation of an elastic and uniform structure of the surgical mesh; and the fourth set of threads increases the stability of the surgical mesh in the transverse direction. 3. The method according to claim 1, in which the first, second and third sequence of loops are at least one of the following: full loops or partial loops. 4. The method according to p. 1, in which the first, second, third and fourth sets of threads contain single-fiber or multi-fiber threads. 5. The method according to p. 1, in which the linear density of the threads of the first, second, third and fourth sets of threads is 46 dtex. 6. The method according to p. 1, in which the diameter of the threads of the first, second, third and fourth sets of threads is from 60 microns to 180 microns. 7. The method according to p. 1, in which the tensile elongation of the threads of the first, second, third and fourth sets of threads is from 20% to 35%. 8. The method according to p. 1, in which the specific gravity of the surgical mesh is approximately 25 to 200 g / m ² . 9. The method according to claim 1, in which the first, second, third and fourth sets of threads contain pure threads or dyed threads. 10. The method according to claim 9, further comprising the step of arranging the dyed yarns at a distance of 1/2 inch (1.27 cm) to 2 inches (5.08 cm) from each other. 11. The method according to p. 1, in which the first, second, third and fourth sets of threads contain polypropylene, polyester or polyvinylidene fluoride. 12. The method according to p. 1, in which the first, second, third and fourth sets of threads contain a coating comprising expanded polytetrafluoroethylene / polytetrafluoroethylene, teflon (Teflon®) or biocompatible synthetic material. 13. The method according to claim 6, in which the surgical mesh contains a coating containing at least one of the following: biocompatible synthetic material, titanium, silicone, antimicrobial substance, absorbable collagen, non-absorbable collagen and graft material. 14. The method according to p. 1, in which the first, second, third and fourth sets of threads contain absorbable threads or non-absorbable threads. 15. The method according to p. 1, further comprising the steps of: the formation of the first weave, the second weave, the third weave and the fourth weave from the first, second, third and fourth sets of threads; the location of the first weave in parallel along the first axis; the location of the second weave in parallel along the second axis perpendicular to the first axis; the location of the third weave in parallel along the third axis, offset approximately 30 ° -60 ° from the first axis; and the location of the fourth weave in parallel along the fourth axis perpendicular to the third axis.

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