CN113855318A - Non-deformable anti-displacement urinary incontinence sling mesh and preparation method thereof - Google Patents

Abstract

The application relates to the field of medical equipment, and provides a non-deformable and anti-displacement urinary incontinence suspender mesh and a preparation method thereof, wherein the surface of the suspender mesh is provided with a plurality of bulges which are uniformly spaced, the suspender mesh has a variable looped double-comb structure and is formed by weaving medical non-absorbable synthetic monofilaments through two groups of different yarn laying tracks; the first group of monofilaments are fully penetrated on a yarn guide comb, and each monofilament is laid on a corresponding knitting needle along the longitudinal direction to form a loop; the second group of monofilaments are fully penetrated on the other yarn guide comb, and each monofilament is alternately lapped and looped on two corresponding adjacent knitting needles along the longitudinal direction. The urinary incontinence suspender mesh surface has a plurality of protruding structures at even intervals, can obviously reduce postoperative displacement risk that the suspender is not hard up to net piece stable in structure and elongation are lower, and non-deformable can show the incidence that reduces postoperative urinary incontinence relapse.

Description

Non-deformable anti-displacement urinary incontinence sling mesh and preparation method thereof

Technical Field

The application belongs to the technical field of medical equipment, relates to a urinary incontinence hanging belt, and particularly relates to a non-deformable anti-displacement urinary incontinence hanging belt mesh and a preparation method thereof.

Background

Stress incontinence refers to involuntary urine leakage from the urethral orifice when abdominal pressure increases, such as sneezing, coughing, laughing, or exercise; for moderate to severe stress urinary incontinence patients, tension-free mid-urethral sling surgery is an internationally recognized first-line treatment. In general, a synthetic mesh belt is used for tension-free urethral middle section suspension in an operation, the mesh belt is placed behind the urethral middle section side without tension, and when abdominal pressure is increased, the mesh belt forms pressure on the urethral middle section to control urine leakage. Since the postoperative patient still has the need to participate in social activities, and in the case of increased abdominal pressure such as cough, the sling may loosen, shift and cause recurrence of urinary incontinence.

In order to reduce the recurrence probability after operation, chinese patent publication No. CN 207012267U discloses a urinary incontinence suspension belt with a braided chain structure, which includes a mesh sheet, and the mesh sheet has a braided mesh and a plurality of braided chain structures arranged side by side, and the extending direction of the braided chain structures on the mesh sheet is consistent with the stress direction of the suspension belt after implantation. The mesh of the sling is rectangular, has lower longitudinal elongation, can reduce the incidence of postoperative infection to a certain extent, but still can not effectively solve the problem of displacement of the mesh of the sling after operation.

Therefore, there is a need to develop a non-deformable anti-migration sling mesh to reduce the recurrence rate of post-operative urinary incontinence.

Disclosure of Invention

Based on the above, the application provides a displacement-preventing urinary incontinence sling mesh which is not easy to deform and has a stable structure, can prevent the mesh from displacement, and can reduce the recurrence rate of the postoperative urinary incontinence, and a preparation method thereof.

The application provides a non-deformable and anti-displacement urinary incontinence hanging strip mesh, wherein a plurality of bulges are uniformly spaced on the surface of the hanging strip mesh, the hanging strip mesh has a variable looped double-comb structure and is formed by weaving medical non-absorbable synthetic monofilaments through two groups of different yarn laying tracks; the first group of monofilaments are fully penetrated on the same yarn guide comb, and each monofilament is laid on a corresponding knitting needle along the longitudinal direction to form a loop; the second group of monofilaments are fully penetrated on the other yarn guide comb, and each monofilament is alternately lapped and looped on two corresponding adjacent knitting needles along the longitudinal direction.

In the embodiments of the present application, the loops of the monofilaments of the two different sets of laying tracks on the knitting needles are in the form of open loops and/or closed loops.

In the embodiment of the application, the aperture of the sling mesh sheet is more than or equal to 1mm, the thickness of the sling mesh sheet is less than or equal to 0.6mm, and the gram weight of the sling mesh sheet is less than or equal to 60g/m²And the elongation at break is less than or equal to 58 percent.

In the embodiment of the application, the transverse density of the sling mesh sheet is less than or equal to 25 columns/inch, and the longitudinal density of the sling mesh sheet is less than or equal to 15 rows/cm.

In embodiments of the present application, the medical non-absorbable synthetic monofilament has a diameter of 0.2mm or less.

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

The application provides a method for preparing the displacement-preventing urinary incontinence sling mesh, which comprises the following steps:

the front and the rear yarn guide combs are arranged on the warp knitting machine, two groups of monofilaments respectively penetrate into the two yarn guide combs and are fully penetrated, and each monofilament in the first group is laid on a corresponding knitting needle along the longitudinal direction to form a loop; and (3) each monofilament in the second group is sequentially laid on two corresponding adjacent knitting needles along the longitudinal direction to form a loop, and the displacement-preventing urinary incontinence sling mesh sheet is obtained by knitting, and has low elongation and a plurality of bulges at uniform intervals on the surface.

In the embodiment of the application, the first group of monofilaments fully penetrates the front guide comb, and the second group of monofilaments fully penetrates the rear guide comb;

or the first group of monofilaments fully penetrates the rear yarn guide comb, and the second group of monofilaments fully penetrates the front yarn guide comb.

Compared with the prior art, the sling mesh sheet is formed by knitting medical non-absorbable synthetic monofilaments through two groups of different yarn laying tracks, the first group of monofilaments are fully penetrated on a yarn guide comb, and each monofilament is looped on a corresponding knitting needle along longitudinal yarn laying; the second group of monofilaments are fully penetrated on the other yarn guide comb, and each monofilament is laid on two corresponding adjacent knitting needles in turn along the longitudinal direction to form a loop, namely a variable looping double comb structure, so that the net piece is not easy to deform, and the surface of the net piece has a uniform interval convex structure. The urinary incontinence suspender mesh surface has a plurality of protruding structures at even intervals, can obviously reduce postoperative displacement risk that the suspender is not hard up to net piece stable in structure and elongation are lower, and non-deformable can show the incidence that reduces postoperative urinary incontinence relapse.

Drawings

FIG. 1 is a movement diagram of a lapping yarn in which two groups of monofilaments are closed and looped according to a first type of embodiment of the present application;

FIG. 2 is a diagram of the movement of a first set of closed looped monofilaments and a second set of open looped monofilaments for a lay-up yarn according to a second type of embodiment of the present application;

FIG. 3 is a diagram of a lay-up yarn movement for a first set of monofilament closed-end looping and a second set of monofilament open-end closed-end looping yarns according to a third type of embodiment of the present application;

FIG. 4 is a diagram of a lay-up yarn movement for a first set of monofilament open-looped and a second set of monofilament closed-looped yarns according to a fourth type of embodiment of the present application;

FIG. 5 is a diagram of the movement of a lapping yarn in which two sets of monofilaments are open looped according to a fifth type of embodiment of the present application;

FIG. 6 is a diagram of a lapping movement of a first set of monofilament open looped, a second set of monofilament closed and open looped yarns according to a sixth class of embodiments of the present application;

FIG. 7 is a schematic view of a preferred embodiment of the present application showing a uniformly spaced raised structure on the surface of an anti-migration urinary incontinence sling mesh.

Detailed Description

The technical solutions in the embodiments of the present application are clearly and completely described below, and it is obvious that the described embodiments are only a part of the embodiments of the present application, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.

The application provides a non-deformable and anti-displacement urinary incontinence sling mesh, wherein the surface of the sling mesh is provided with a plurality of bulges which are uniformly spaced, the sling mesh has a variable looping double comb structure and is formed by weaving medical non-absorbable synthetic monofilaments through two groups of different yarn laying tracks; the first group of monofilaments are fully penetrated on the same yarn guide comb, and each monofilament is laid on a corresponding knitting needle along the longitudinal direction to form a loop; the second group of monofilaments are fully penetrated on the other yarn guide comb, and each monofilament is alternately lapped and looped on two corresponding adjacent knitting needles along the longitudinal direction.

The embodiment of the application also provides a preparation method of the displacement-preventing urinary incontinence sling mesh, which comprises the following steps:

the front and the rear yarn guide combs are arranged on the warp knitting machine, two groups of monofilaments respectively penetrate into the two yarn guide combs and are fully penetrated, and each monofilament in the first group is laid on a corresponding knitting needle along the longitudinal direction to form a loop; and (3) each monofilament in the second group is sequentially laid on two corresponding adjacent knitting needles along the longitudinal direction to form a loop, and the displacement-preventing urinary incontinence sling mesh sheet is obtained by knitting, wherein the surface of the displacement-preventing urinary incontinence sling mesh sheet is provided with a plurality of bulges at uniform intervals.

The urinary incontinence hanging strip mesh can obviously reduce postoperative displacement risk caused by loosening of the hanging strip and improve postoperative cure rate.

The urinary incontinence hanging strip mesh of the warp-knitted tissue is prepared by adopting an original weaving process, and the surface of the urinary incontinence hanging strip mesh is provided with a plurality of bulges at uniform intervals and is not easy to deform so as to solve the problems of deformation and displacement of the hanging strip in the body. In the embodiment of the application, the first group of monofilaments fully penetrates the front guide comb, and the second group of monofilaments fully penetrates the rear guide comb; or the first group of monofilaments fully penetrates the rear yarn guide comb, and the second group of monofilaments fully penetrates the front yarn guide comb.

The surface of the sling mesh sheet provided by the embodiment of the application is provided with a plurality of bulges which are uniformly spaced, the mesh sheet is formed by weaving medical non-absorbable synthetic monofilaments through two groups of different yarn laying tracks, and has a variable looping double-comb structure; see the yarn laying movement diagrams of two groups of monofilaments of several classes of embodiments of figures 1 to 6.

Corresponding to the variable looping double comb structure, a first group of monofilaments are fully penetrated on a yarn guide comb, and each monofilament is laid on a corresponding knitting needle along the longitudinal direction to form loops; the second group of monofilaments are fully penetrated on the other yarn guide comb, and each monofilament is alternately lapped and looped on two corresponding adjacent knitting needles along the longitudinal direction, so that a net sheet with uniformly spaced convex surfaces and low elongation can be formed.

In the embodiment of the application, the loop formation of the monofilaments of the two different yarn laying tracks on the knitting needle can be an open loop or a closed loop. According to the yarn laying movement diagram, the two extending lines of the stitch are crossed and overlapped at the base of the stitch and are called closed stitch, and the stitch without crossing and overlapping is called closed stitch.

FIG. 1 is a movement diagram of the closed loop lapping of two groups of monofilaments of the anti-displacement sling mesh, namely, each monofilament of the first group is lapped and looped on a corresponding knitting needle along the longitudinal closed loop, and each monofilament of the second group is lapped and looped on two corresponding adjacent knitting needles along the longitudinal closed loop in turn.

FIG. 2 is a drawing showing the movement of a first group of closed loop and a second group of open loop monofilaments of an anti-shifting sling mesh, wherein each monofilament of the first group is looped on a corresponding knitting needle along the longitudinal closed loop, and each monofilament of the second group is looped on two corresponding adjacent knitting needles along the longitudinal alternate open loop.

Fig. 3 is a yarn laying movement diagram of a first group of monofilament closed loop forming and a second group of monofilament open and closed loop forming of the anti-displacement sling net piece, namely, each monofilament in the first group is looped on a corresponding knitting needle along the longitudinal closed loop yarn laying, and each monofilament in the second group is looped on two corresponding adjacent knitting needles along the longitudinal direction by opening first and then closing or opening first and then closing in turn.

FIG. 4 is a diagram showing the movement of a first group of monofilaments in an open loop and a second group of monofilaments in a closed loop of an anti-shifting sling mesh, wherein each monofilament in the first group is looped on a corresponding knitting needle along a longitudinal opening and each monofilament in the second group is looped on two corresponding adjacent knitting needles along a longitudinal opening in turn.

FIG. 5 is a movement diagram of a first group of monofilaments and a second group of monofilaments of the anti-migration sling mesh being open-looped, wherein each monofilament of the first group is open-looped in a longitudinal direction on a corresponding knitting needle, and each monofilament of the second group is open-looped in a longitudinal direction on two adjacent knitting needles corresponding to the monofilament of the second group.

Fig. 6 is a movement diagram of the lapping of the first group of monofilaments for open looping and the second group of monofilaments for closed and open looping of the anti-displacement sling mesh, namely, each monofilament in the first group is lapped and looped on a corresponding knitting needle along the longitudinal opening, and each monofilament in the second group is lapped and looped on two corresponding adjacent knitting needles along the longitudinal direction by opening first and then closing or opening first and then closing in turn.

In a specific embodiment of the present application, the aperture of the anti-displacement sling mesh sheet is greater than or equal to 1mm, and further, the aperture range is 1mm to 2.3mm (the aperture in this range refers to the whole range, and the multiplier may also be used to indicate the aperture in the longitudinal and transverse directions of the structure, such as the transverse dimension and the longitudinal dimension); the elongation at break is less than or equal to 58 percent, and further, the elongation range of the net sheet is 30 to 58 percent; the coefficient of dynamic friction is more than or equal to 0.382, and further more, the coefficient of dynamic friction is more than or equal to 0.403. The sling mesh has the advantages of large dynamic friction coefficient and low elongation, can obviously reduce the postoperative displacement risk caused by the looseness of the sling, reduces the postoperative recurrence probability, and has obvious technical advantages.

According to the mesh process design, the transverse density of the sling mesh is less than or equal to 25 columns/inch, and the longitudinal density is less than or equal to 15 rows/cm. In addition, the method can be used for producing a composite materialThe thickness of the sling net sheet is less than or equal to 0.6mm, and the gram weight is less than or equal to 60g/m². In some embodiments of the present application, the sling mesh has a cross-directional density of 10-25 wales/inch, a longitudinal density of 6-15 wales/cm, a thickness of 0.41-0.6mm, and a grammage of 35-60g/m²。

The sling mesh is a variable looped double comb mesh woven from medical non-absorbable synthetic monofilaments; wherein, the medical fiber material has good biocompatibility. In the embodiment of the application, the diameter of the medical non-absorbable synthetic monofilament is less than or equal to 0.2mm, and specifically can be 0.08mm-0.2mm and the like; it includes medical polypropylene (PP) monofilament, Polyester (PET) monofilament, Polyamide (PA) monofilament or polyvinylidene fluoride (PVDF) monofilament, etc.

The sling mesh sheet has wide raw material variety, and the sling mesh sheet prepared from different raw materials can meet the requirements of patients with different urinary incontinence degrees.

The preparation process of the displacement-preventing sling mesh not easy to deform in the embodiment of the application is as follows: preparing before knitting, shaping and post-processing; the specific operation of weaving is as follows:

according to the yarn laying motion diagram of the embodiment of the application, each monofilament in the first group (fully threaded on the front guide bar) is looped on one corresponding knitting needle along the longitudinal yarn laying, each monofilament in the second group (fully threaded on the rear guide bar) is looped on two corresponding adjacent knitting needles along the longitudinal yarn laying in turn, and the sling mesh fabric is woven.

The displacement-preventing sling mesh sheet which is not easy to deform in the embodiment of the application has multiple knitting forming paths, can be knitted into a wide mesh sheet firstly and then cut into a standard strip or a strip form with two narrow ends and a wide middle part, and can also be directly knitted into a strip; and the two ends of the strap can be combined with various accessories, the two tail end heads are convenient to process and can be combined with the anchor nails, the requirements of different operation types are met, and the applicability is wide.

In addition, the preparation process of the sling mesh sheet is stable and efficient, the cost is reduced, and the economic burden of patients is relieved.

For further understanding of the present application, the non-deformable anti-displacement urinary incontinence sling mesh provided herein and the method of making the same are described in detail below with reference to the examples. The starting materials used in the following examples of the present application are all commercially available products.

Example 1

In this example, medical polypropylene monofilament is selected as a raw material, and the properties thereof are shown in table 1.

TABLE 1 Material selection and Properties

Kind of raw material	Diameter (mm)	Breaking Strength (gf/d)	Elongation at Break (%)
				PP monofilament	0.13	5.2	18

Knitting was performed by a warp knitting machine, and the specific knitting process is shown in table 2.

TABLE 2 weaving Process parameters

The breaking strength and elongation test method refers to GB/T3923.1 part 1 of tensile property of textile fabrics: the method for testing the breaking strength and the breaking elongation (strip sampling method) refers to the medical industry standard YY0500 cardiovascular implant, and the dynamic friction coefficient refers to the test method of the friction performance of the fabric surface FZT 01054-:

table 3 sling mesh performance data for this example

Moreover, as can be seen from the comparison of the data in table 4, the sling mesh sheet for preventing the urinary incontinence, which is not easy to deform, has a kinetic friction coefficient obviously higher than that of sling products of Qiangsheng, Boston science and AMS, and has a breaking elongation obviously lower than that of the sling products. The displacement-preventing urinary incontinence sling mesh sheet disclosed by the embodiment is not easy to deform and is displacement-resistant compared with sling products on the market, and has obvious advantages in the aspect of reducing the recurrence rate of urinary incontinence.

TABLE 4 comparison of the performance of the light and thin anti-shrinking sling mesh of the present embodiment with that of the commercial sling

Product(s)	Thickness (mm)	Gram weight (g/m)2)	Coefficient of dynamic friction	Elongation at Break (%)
					Strap mesh of the present embodiment	0.44	42	0.403	58
Strong sling product	0.63	100	0.184	108
					Boston science suspender product	0.66	100	0.205	107
AMS suspender product	0.66	110	0.191	115

Example 2

In this example, medical polyester monofilament is selected as a raw material, and the properties thereof are shown in table 5.

TABLE 5 Material selection and Properties

Kind of raw material	Diameter (mm)	Breaking Strength (gf/d)	Elongation at Break (%)
				PET monofilament	0.2	6.8	19

Knitting was performed by a warp knitting machine, and the specific knitting process is shown in table 6.

TABLE 6 knitting Process parameters

The breaking strength and elongation test method refers to GB/T3923.1 part 1 of tensile property of textile fabrics: the method for testing the breaking strength and the breaking elongation (strip sampling method) refers to the medical industry standard YY0500 cardiovascular implant, and the dynamic friction coefficient refers to the test method of the friction performance of the fabric surface FZT 01054-:

table 7 sling mesh performance data for this example

Example 3

In this example, medical polyvinylidene fluoride monofilament was selected as a raw material, and the properties thereof are shown in table 8.

TABLE 8 Material selection and Properties

Kind of raw material	Diameter (mm)	Breaking Strength (gf/d)	Elongation at Break (%)
				PVDF monofilament	0.08	3	28

Knitting was performed by a warp knitting machine, and the specific knitting process is shown in table 9.

TABLE 9 knitting Process parameters

The breaking strength and elongation test method refers to GB/T3923.1 part 1 of tensile property of textile fabrics: the method for testing the breaking strength and the breaking elongation (strip sampling method) refers to the medical industry standard YY0500 cardiovascular implant, and the dynamic friction coefficient refers to the test method of the friction performance of the fabric surface FZT 01054-:

table 10 sling mesh performance data for this example

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims (8)

1. The sling mesh sheet is characterized in that the surface of the sling mesh sheet is provided with a plurality of bulges which are uniformly spaced, the sling mesh sheet has a variable looped double-comb structure and is formed by weaving medical non-absorbable synthetic monofilaments through two groups of different yarn laying tracks; the first group of monofilaments are fully penetrated on the same yarn guide comb, and each monofilament is laid on a corresponding knitting needle along the longitudinal direction to form a loop; the second group of monofilaments are fully penetrated on the other yarn guide comb, and each monofilament is alternately lapped and looped on two corresponding adjacent knitting needles along the longitudinal direction.

2. The anti-migration urinary incontinence sling mesh according to claim 1 wherein the two sets of monofilaments of different yarn laying tracks are looped on knitting needles in the form of open loops and/or closed loops.

3. The anti-displacement urinary incontinence sling mesh sheet according to claim 1, wherein the sling mesh sheet has an aperture of not less than 1mm, a thickness of not more than 0.6mm and a gram weight of not more than 60g/m²And the elongation at break is less than or equal to 58 percent.

4. The anti-migration urinary incontinence sling mesh sheet according to claim 1, wherein the sling mesh sheet has a lateral density of 25 columns/inch or less and a longitudinal density of 15 rows/cm or less.

5. The anti-migration urinary incontinence sling mesh of claim 1 wherein said medical non-absorbable synthetic monofilament has a diameter of 0.2mm or less.

6. The anti-migration urinary incontinence sling mesh according to any one of claims 1-5 wherein said medical non-absorbable synthetic monofilaments include polypropylene monofilaments, polyester monofilaments, polyamide monofilaments or polyvinylidene fluoride monofilaments.

7. The method of making a displacement urinary incontinence sling mesh as claimed in any one of claims 1 to 6, including the steps of:

a front guide comb and a rear guide comb are arranged on the warp knitting machine, and two groups of monofilaments respectively penetrate through the two guide combs and are fully penetrated; each monofilament in the first group is laid on a corresponding knitting needle along the longitudinal direction to form a loop; and (3) each monofilament in the second group is sequentially laid on two corresponding adjacent knitting needles along the longitudinal direction to form a loop, and the displacement-preventing urinary incontinence sling mesh sheet is obtained by knitting, wherein the surface of the displacement-preventing urinary incontinence sling mesh sheet is provided with a plurality of bulges at uniform intervals.

8. The method of claim 7, wherein the first set of filaments is fully threaded on the front guide comb and the second set of filaments is fully threaded on the rear guide comb;

or the first group of monofilaments fully penetrates the rear yarn guide comb, and the second group of monofilaments fully penetrates the front yarn guide comb.

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