A non-deformable anti-displacement urinary incontinence sling mesh and its preparation method

Abstract

The present application relates to the field of medical devices. The present application provides a non-deformable anti-displacement urinary incontinence sling mesh and a preparation method thereof. The surface of the sling mesh has a plurality of evenly spaced protrusions. The sling mesh has a variable loop double-comb structure and is woven from medical non-absorbable synthetic monofilaments through two sets of different yarn padding trajectories. The first set of monofilaments is fully threaded on a yarn guide comb, and each monofilament is yarn-padded and looped longitudinally on a corresponding knitting needle; the second set of monofilaments is fully threaded on another yarn guide comb, and each monofilament is yarn-padded and looped longitudinally on two corresponding adjacent knitting needles in turn. The urinary incontinence sling mesh described in the present application has a plurality of evenly spaced protrusions on its surface, which can significantly reduce the risk of postoperative displacement caused by loosening of the sling. The mesh structure is stable and has a low elongation, is not easily deformed, and can significantly reduce the incidence of postoperative urinary incontinence recurrence.

Description

Technical Field

[0001] The present application belongs to the technical field of medical devices and relates to a urinary incontinence sling, and in particular to a non-deformable anti-displacement urinary incontinence sling mesh and a preparation method thereof. Background Art

[0002] Stress urinary incontinence is the involuntary leakage of urine from the urethra when abdominal pressure increases, such as from sneezing, coughing, laughing, or exercising. For patients with moderate to severe stress urinary incontinence, tension-free mid-urethral sling surgery is an internationally recognized first-line treatment. The procedure typically uses a synthetic mesh sling, which is placed tension-free at the posterior and lateral sides of the mid-urethra. When abdominal pressure increases, the mesh exerts pressure on the mid-urethra, controlling urinary leakage. However, since patients still need to participate in social activities after surgery and experience increased abdominal pressure, such as from coughing, the sling may loosen and shift, leading to recurrence of urinary incontinence.

[0003] To reduce the risk of postoperative recurrence, Chinese patent publication CN 207012267 U discloses a urinary incontinence sling with a braided chain structure. The sling comprises a mesh with woven mesh openings and a plurality of parallel braided chain structures. The chain structures extend along the mesh in the direction consistent with the force applied to the sling after implantation. The sling's mesh features rectangular openings and low longitudinal elongation, which can reduce the incidence of postoperative infection to some extent. However, it still fails to effectively address the problem of mesh displacement after surgery.

[0004] Therefore, there is an urgent need to develop an anti-displacement sling mesh that is not easily deformed to reduce the recurrence rate of postoperative urinary incontinence. Summary of the Invention

[0005] Based on this, the present application provides a non-deformable anti-displacement urinary incontinence sling mesh and a preparation method thereof. The urinary incontinence sling mesh has a stable structure, can prevent the mesh from shifting, and can reduce the recurrence rate of postoperative urinary incontinence.

[0006] The present application provides a non-deformable anti-displacement urinary incontinence sling mesh, the surface of which has a number of evenly spaced protrusions, and the sling mesh has a variable loop double-comb structure, which is woven from medical non-absorbable synthetic monofilaments through two groups of different yarn padding trajectories; the first group of monofilaments is fully threaded on the same yarn guide comb, and each monofilament is yarn-padded and looped on a corresponding knitting needle in the longitudinal direction; the second group of monofilaments is fully threaded on another yarn guide comb, and each monofilament is yarn-padded and looped on two corresponding adjacent knitting needles in turn in the longitudinal direction.

[0007] In an embodiment of the present application, the loop forms of the monofilaments of the two groups of different inlay yarn tracks on the knitting needles are open coils and / or closed coils.

[0008] In the embodiment of the present application, the sling mesh has a pore size of ≥1mm, a thickness of ≤0.6mm, and a gram weight of ≤60g / m 2 , elongation at break ≤58%.

[0009] In an embodiment of the present application, the sling mesh has a transverse density of ≤25 longitudinal rows / inch and a longitudinal density of ≤15 transverse rows / cm.

[0010] In an embodiment of the present application, the diameter of the medical non-absorbable synthetic monofilament is ≤0.2 mm.

[0011] In the embodiments of the present application, the medical non-absorbable synthetic monofilament includes polypropylene monofilament, polyester monofilament, polyamide monofilament or polyvinylidene fluoride monofilament.

[0012] The present application provides a method for preparing the aforementioned anti-displacement urinary incontinence sling mesh, comprising the following steps:

[0013] Two front and rear yarn guide combs are installed on the warp knitting machine, and two groups of monofilaments are respectively passed through the two yarn guide combs, and both are fully passed through. Each monofilament of the first group is looped along the longitudinal direction on a corresponding knitting needle; each monofilament of the second group is looped along the longitudinal direction on two corresponding adjacent knitting needles in turn, and an anti-displacement urinary incontinence sling mesh is woven, which has low elongation and a number of protrusions evenly spaced on the surface.

[0014] In an embodiment of the present application, the first group of monofilaments is fully threaded onto the front yarn guide comb, and the second group of monofilaments is fully threaded onto the rear yarn guide comb;

[0015] Alternatively, the first group of monofilaments are fully threaded onto the rear yarn guide comb, and the second group of monofilaments are fully threaded onto the front yarn guide comb.

[0016] Compared to the prior art, the sling mesh described in this application is woven from medical non-absorbable synthetic monofilaments using two different yarn padding trajectories. The first group of monofilaments is fully threaded through a yarn guide comb, and each monofilament is looped longitudinally on its corresponding knitting needle; the second group of monofilaments is fully threaded through another yarn guide comb, and each monofilament is looped longitudinally on its corresponding two adjacent knitting needles in turn, creating a variable looping double-comb structure. This makes the mesh less prone to deformation and has evenly spaced raised structures on its surface. The urinary incontinence sling mesh described in this application has several evenly spaced raised structures on its surface, which can significantly reduce the risk of postoperative displacement caused by loosening of the sling. The mesh structure is stable and has a low elongation, making it less prone to deformation and significantly reducing the incidence of postoperative urinary incontinence recurrence. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 This is a motion diagram of the yarn laying in which two groups of monofilaments are both closed-end looped in the first embodiment of the present application;

[0018] Figure 2 This is a diagram of the laying motion of the first group of monofilaments forming closed loops and the second group of monofilaments forming open loops in the second embodiment of the present application;

[0019] Figure 3 This is a diagram of the laying motion of the first group of monofilaments in closed loops and the second group of monofilaments in open and closed loops in the third embodiment of the present application;

[0020] Figure 4 This is a diagram of the laying motion of the first group of monofilaments forming open loops and the second group of monofilaments forming closed loops in the fourth embodiment of the present application;

[0021] Figure 5 This is a motion diagram of the yarn laying in which both groups of monofilaments are open and looped in the fifth embodiment of the present application;

[0022] Figure 6 This is a diagram of the laying motion of the first group of monofilaments forming open loops and the second group of monofilaments forming closed loops and open loops in the sixth embodiment of the present application;

[0023] Figure 7 This is a schematic diagram of the structure of evenly spaced protrusions on the surface of the anti-displacement urinary incontinence sling mesh according to the preferred embodiment of the present application. DETAILED DESCRIPTION

[0024] The following is a clear and complete description of the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of them. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0025] The present application provides a non-deformable anti-displacement urinary incontinence sling mesh, the surface of which has a number of evenly spaced protrusions, the sling mesh having a variable loop double-comb structure, and is woven from medical non-absorbable synthetic monofilaments through two groups of different yarn padding trajectories; the first group of monofilaments is fully threaded on the same yarn guide comb, and each monofilament is yarn-padded and looped on a corresponding knitting needle in the longitudinal direction; the second group of monofilaments is fully threaded on another yarn guide comb, and each monofilament is yarn-padded and looped on two corresponding adjacent knitting needles in turn in the longitudinal direction.

[0026] The present application also provides a method for preparing the aforementioned anti-displacement urinary incontinence sling mesh, comprising the following steps:

[0027] Two front and rear yarn guide combs are installed on the warp knitting machine, and two groups of monofilaments are respectively passed through the two yarn guide combs, and both are fully passed through. Each monofilament of the first group is looped along the longitudinal direction on a corresponding knitting needle; each monofilament of the second group is looped along the longitudinal direction on two corresponding adjacent knitting needles in turn, and an anti-displacement urinary incontinence sling mesh is woven, the surface of which has a number of protrusions evenly spaced.

[0028] The urinary incontinence sling mesh provided in the present application can significantly reduce the risk of postoperative displacement caused by sling loosening and improve the postoperative cure rate.

[0029] The embodiment of the present application utilizes a unique weaving process to produce the warp-knitted urinary incontinence sling mesh. The surface of the warp-knitted urinary incontinence sling has a plurality of evenly spaced protrusions that are non-deformable, thereby preventing the sling from deforming and shifting within the body. In the embodiment of the present application, the first group of monofilaments is fully threaded onto the leading yarn guide, and the second group of monofilaments is fully threaded onto the trailing yarn guide; alternatively, the first group of monofilaments is fully threaded onto the trailing yarn guide, and the second group of monofilaments is fully threaded onto the leading yarn guide.

[0030] The surface of the sling mesh described in the embodiment of the present application has a number of evenly spaced protrusions. The mesh is woven from medical non-absorbable synthetic monofilaments through two sets of different yarn padding tracks and has a variable loop double comb structure; see Figures 1 to 6 Graphs of the laying motion of two groups of monofilaments for several types of embodiments.

[0031] Corresponding to the variable loop-forming double-comb structure described in the present application, the first group of monofilaments are fully threaded on a yarn guide comb, and each monofilament is looped in the longitudinal direction on a corresponding knitting needle; the second group of monofilaments are fully threaded on another yarn guide comb, and each monofilament is looped in the longitudinal direction on two corresponding adjacent knitting needles in turn, which can form a mesh with evenly spaced protrusions on the surface and low elongation.

[0032] In the embodiments of the present application, the monofilaments of the two sets of different inlay yarn trajectories can be looped on the knitting needle in either an open loop or a closed loop. According to the inlay yarn motion diagram, a loop in which the two extension lines of the loop intersect and overlap at the base of the loop is called a closed loop, and a loop in which there is no intersection or overlap is called a closed loop.

[0033] Figure 1 To prevent the displacement of the sling mesh, the two groups of monofilaments are both closed and looped. That is, each monofilament of the first group is closed and looped along the longitudinal direction on its corresponding knitting needle, and each monofilament of the second group is closed and looped along the longitudinal direction on its corresponding two adjacent knitting needles in turn.

[0034] Figure 2 The diagram shows the movement of the yarn padding of the first group of monofilaments in closed loops and the second group of monofilaments in open loops for the anti-shifting sling mesh, that is, each monofilament of the first group is yarn-padded in closed loops along the longitudinal direction on its corresponding one knitting needle, and each monofilament of the second group is yarn-padded in open loops along the longitudinal direction on its corresponding two adjacent knitting needles in turn.

[0035] Figure 3The motion diagram of the yarn padding of the first group of monofilaments of the anti-shifting sling mesh is that they form closed loops, and the second group of monofilaments form open and closed loops, that is, each monofilament of the first group is yarn-padded in a closed loop along the longitudinal direction on one of its corresponding knitting needles, and each monofilament of the second group is yarn-padded in a loop on two corresponding adjacent knitting needles in the longitudinal direction, first open and then closed, or first closed and then open, in turn.

[0036] Figure 4 The diagram shows the movement of the yarn padding of the first group of monofilaments in open loops and the second group of monofilaments in closed loops for the anti-shifting sling mesh, that is, each monofilament of the first group is yarn-padded in an open loop along the longitudinal direction on its corresponding knitting needle, and each monofilament of the second group is yarn-padded in a closed loop in the longitudinal direction on its corresponding two adjacent knitting needles in turn.

[0037] Figure 5 The motion diagram of the yarn padding of the first and second groups of monofilaments of the anti-shifting sling mesh is shown, that is, each monofilament of the first group is looped in the longitudinal direction on one of its corresponding knitting needles, and each monofilament of the second group is looped in the longitudinal direction on two adjacent knitting needles in turn.

[0038] Figure 6 The motion diagram of the yarn padding of the first group of monofilaments of the anti-shifting sling mesh is that they are open-looped and the second group of monofilaments are closed-looped and open-looped. That is, each monofilament of the first group is looped along the longitudinal opening on its corresponding knitting needle, and each monofilament of the second group is looped along the longitudinal direction on its corresponding two adjacent knitting needles in alternating patterns of first closing and then opening or first opening and then closing.

[0039] In a specific embodiment of the present application, the pore size of the aforementioned anti-displacement sling mesh is ≥1mm, and further, the pore size range is 1mm-2.3mm (this range of pore size refers to the overall range, and the pore size in the longitudinal and transverse directions of the structure can also be represented by a multiplication sign, such as transverse dimension * longitudinal dimension); and its elongation at break is ≤58%, and further, the mesh elongation range is 30%-58%; its dynamic friction coefficient is ≥0.382, and further, the dynamic friction coefficient is ≥0.403. The sling mesh has a large dynamic friction coefficient and low elongation, which can significantly reduce the risk of postoperative displacement caused by sling loosening and reduce the chance of postoperative recurrence, thus having obvious technical advantages.

[0040] According to the mesh process design, the transverse density of the sling mesh in the embodiment of the present application is ≤25 longitudinal rows / inch, and the longitudinal density is ≤15 transverse rows / cm. In addition, the thickness of the sling mesh is ≤0.6mm, and the weight is ≤60g / m 2 In some embodiments of the present application, the sling mesh has a transverse density of 10-25 longitudinal rows / inch, a longitudinal density of 6-15 transverse rows / cm, a thickness of 0.41-0.6 mm, and a gram weight of 35-60 g / m 2 .

[0041] The sling mesh described in this application is a double-comb tissue mesh woven from medical non-absorbable synthetic monofilaments in a looped pattern. The medical fiber material has excellent biocompatibility. In embodiments of this application, the non-absorbable synthetic monofilaments have a diameter of 0.2 mm or less, specifically ranging from 0.08 mm to 0.2 mm. These monofilaments include medical-grade polypropylene (PP), polyester (PET), polyamide (PA), or polyvinylidene fluoride (PVDF) monofilaments.

[0042] The sling mesh described in the present application is applicable to a wide variety of raw materials, and such sling meshes made of different raw materials can meet the needs of patients with different degrees of urinary incontinence.

[0043] The preparation process of the anti-displacement sling mesh that is not easily deformed in the embodiment of the present application is as follows: pre-weaving preparation - weaving - shaping - post-processing; the specific operations of weaving are as follows:

[0044] On the warp knitting machine, two front and rear combs are installed, and two groups of monofilaments are respectively passed through the two yarn guide combs, and both are fully passed through. According to the yarn padding motion diagram of the embodiment of the present application, each monofilament of the first group (fully passed through the front yarn guide comb) is yarn-padded and looped on a corresponding knitting needle along the longitudinal direction, and each monofilament of the second group (fully passed through the rear yarn guide comb) is yarn-padded and looped on two corresponding adjacent knitting needles in turn along the longitudinal direction to weave the sling mesh fabric.

[0045] The anti-displacement sling mesh that is not easily deformed in the embodiment of the present application has multiple weaving forming paths. It can be woven into a wide mesh and then cut into a standard strip or a strip that is narrow at both ends and wide in the middle. It can also be directly woven into a strip. The two ends of the strip can be combined with various accessories, and the two end heads are easy to process and can be combined with anchor nails to meet the needs of different surgical procedures and have a wide applicability.

[0046] In addition, the preparation process of the sling mesh of the present application is stable and efficient, which helps to reduce costs and alleviate the economic burden of the majority of patients.

[0047] In order to further understand the present application, the following embodiments are used to specifically describe the non-deformable anti-displacement urinary incontinence sling mesh and its preparation method. The raw materials used in the following embodiments of the present application are all commercially available products.

[0048] Example 1

[0049] In this embodiment, medical polypropylene monofilament is selected as the raw material, and its properties are shown in Table 1.

[0050] Table 1 Material selection and performance

[0051] Types of raw materials Diameter (mm) Breaking strength (gf / d) Elongation at break (%) PP monofilament 0.13 5.2 18

[0052] The weaving is performed by a warp knitting machine, and the specific machine process is shown in Table 2.

[0053] Table 2 Weaving process parameters

[0054]

[0055] The test methods for breaking strength and elongation refer to GB / T 3923.1 "Tensile properties of textile fabrics Part 1: Determination of breaking strength and elongation at break (Strip method)", the test methods for thickness and pore size refer to the pharmaceutical industry standard YY0500 "Cardiovascular implants", and the dynamic friction coefficient refers to FZT 01054-2012 "Test method for friction properties of fabric surfaces". The test results are as follows:

[0056] Table 3 Performance data of the sling mesh of this embodiment

[0057]

[0058] Furthermore, a comparison of the data in Table 4 shows that the coefficient of dynamic friction of the non-deformable anti-displacement urinary incontinence sling mesh of this embodiment is significantly higher than that of sling products from Johnson & Johnson, Boston Scientific, and AMS, and its elongation at break is also significantly lower than those of these products. This indicates that the non-deformable anti-displacement urinary incontinence sling mesh of this embodiment is more non-deformable and resistant to displacement than sling products on the market, and has a significant advantage in reducing the recurrence rate of urinary incontinence.

[0059] Table 4 Performance comparison of the thin and light anti-shrinkage sling mesh of this embodiment and sling products on the market

[0060] product Thickness (mm) <![CDATA[Grammage (g / m 2 )]]> Dynamic friction coefficient Elongation at break (%) The sling mesh of this embodiment 0.44 42 0.403 58 Johnson sling products 0.63 100 0.184 108 Boston Scientific Sling Products 0.66 100 0.205 107 AMS sling products 0.66 110 0.191 115

[0061] Example 2

[0062] In this embodiment, medical polyester monofilament is selected as the raw material, and its properties are shown in Table 5.

[0063] Table 5 Material selection and performance

[0064] Types of raw materials Diameter (mm) Breaking strength (gf / d) Elongation at break (%) PET monofilament 0.2 6.8 19

[0065] The weaving is performed by a warp knitting machine, and the specific machine process is shown in Table 6.

[0066] Table 6 Weaving process parameters

[0067]

[0068] The test methods for breaking strength and elongation refer to GB / T 3923.1 "Tensile properties of textile fabrics Part 1: Determination of breaking strength and elongation at break (Strip method)", the test methods for thickness and pore size refer to the pharmaceutical industry standard YY0500 "Cardiovascular implants", and the dynamic friction coefficient refers to FZT 01054-2012 "Test method for friction properties of fabric surfaces". The test results are as follows:

[0069] Table 7 Performance data of the sling mesh of this embodiment

[0070]

[0071] Example 3

[0072] In this embodiment, medical polyvinylidene fluoride monofilament is selected as the raw material, and its properties are shown in Table 8.

[0073] Table 8 Material selection and performance

[0074] Types of raw materials Diameter (mm) Breaking strength (gf / d) Elongation at break (%) PVDF monofilament 0.08 3 28

[0075] The weaving is performed by a warp knitting machine, and the specific machine process is shown in Table 9.

[0076] Table 9 Weaving process parameters

[0077]

[0078] The test methods for breaking strength and elongation refer to GB / T 3923.1 "Tensile properties of textile fabrics Part 1: Determination of breaking strength and elongation at break (Strip method)", the test methods for thickness and pore size refer to the pharmaceutical industry standard YY0500 "Cardiovascular implants", and the dynamic friction coefficient refers to FZT 01054-2012 "Test method for friction properties of fabric surfaces". The test results are as follows:

[0079] Table 10 Performance data of the sling mesh of this embodiment

[0080]

[0081] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0082] The above-described embodiments merely illustrate several implementations of the present invention, and while their descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the patent for this invention shall be determined by the appended claims.

Claims

1. A non-deformable anti-displacement urinary incontinence sling mesh, characterized in that: The sling mesh has a plurality of evenly spaced protrusions on its surface and has a double-comb structure with variable looping, and is woven from medical non-absorbable synthetic monofilaments through two sets of different yarn laying tracks; the first set of monofilaments is fully threaded on the same yarn guide comb, and each monofilament is yarn-laid and looped longitudinally on a corresponding knitting needle; the second set of monofilaments is fully threaded on another yarn guide comb, and each monofilament is yarn-laid and looped longitudinally on two adjacent knitting needles in turn; The sling mesh has a pore size of 1-3.2 mm, a thickness of 0.41-0.6 mm, and a gram weight of 35-60 g / m 2 , the elongation at break is 30%-58%; the transverse density of the sling mesh is ≤25 longitudinal rows / inch, and the longitudinal density is ≤15 transverse rows / cm; the diameter of the medical non-absorbable synthetic monofilament is ≤0.2mm; the medical non-absorbable synthetic monofilament includes polypropylene monofilament, polyester monofilament, polyamide monofilament or polyvinylidene fluoride monofilament.

2. The anti-displacement urinary incontinence sling mesh according to claim 1, characterized in that: The monofilaments of the two groups of different inlay yarn tracks are looped on the knitting needles in the form of open coils and / or closed coils.

3. A method for preparing the anti-displacement urinary incontinence sling mesh according to any one of claims 1 to 2, comprising the following steps: Two front and rear yarn guide combs are installed on the warp knitting machine, and two groups of monofilaments are respectively passed through the two yarn guide combs, and both are fully passed through; each monofilament of the first group is looped along the longitudinal direction on a corresponding knitting needle; each monofilament of the second group is looped along the longitudinal direction on two corresponding adjacent knitting needles in turn, and an anti-displacement urinary incontinence sling mesh is woven, the surface of which has a number of protrusions evenly spaced.

4. The preparation method according to claim 3, characterized in that The first group of monofilaments is fully threaded onto the front yarn guide comb, and the second group of monofilaments is fully threaded onto the rear yarn guide comb; Alternatively, the first group of monofilaments are fully threaded onto the rear yarn guide comb, and the second group of monofilaments are fully threaded onto the front yarn guide comb.

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