Novel pelvic floor patch

Abstract

The utility model discloses a novel pelvic floor patch which is formed by assembling a patch body A and a patch body B. The patch body A is of a rectangular structure, the patch body B is in a long strip shape, the two opposite edges of the patch body A are each provided with a slit, the two ends of the patch body B are wide and the center of the patch body B is narrow or the two ends of the patch body B are narrow and the center of the patch body B is wide, the patch body B penetrates through the two slits of the patch body A, and the central area of the patch body B is located between the two slits of the patch body A. A plurality of holes are formed in the overlapped parts of the patch A and the patch B and penetrate through the patch A and the patch B. The width of the narrower part of the patch A is not greater than the length of the slit of the patch A, and the width of the wider part of the patch A is greater than the length of the slit of the patch A. According to the utility model, leftover materials can be greatly reduced, and the utilization rate of raw materials is improved; after assembly, the hole in the overlapped part of the patch A and the patch B can guide the soft tissue to penetrate and grow in, so that an anchoring effect similar to that of a suture line is achieved, the patch A and the patch B are prevented from being staggered, and the patch has a wide application prospect and is beneficial to popularization and application.

Description

Technical Field

[0001] The utility model relates to the technical field of biomedical materials and regenerative treatment, in particular to a novel pelvic floor patch. Background Art

[0002] Pelvic organ prolapse (POP) is an abnormal position and dysfunction of the organs caused by the descent of the pelvic organs due to abnormal pelvic floor muscles and fascia tissues. The main symptom is the prolapse of the vaginal opening, which may be accompanied by urination, defecation and sexual dysfunction, affecting the patient's quality of life to varying degrees. The disease has a higher incidence in middle-aged and elderly women. At present, POP patients can choose non-surgical treatment and surgical treatment. Mild and moderate patients mostly choose non-surgical treatment, while severe patients need to choose appropriate surgical procedures according to individual conditions. Common surgical treatments include traditional surgery, pelvic floor reconstruction, laparoscopic surgery and da Vinci robot surgery. Pelvic floor reconstruction with transvaginal mesh (TVM) has considerable advantages in repositioning the defective part and reducing the recurrence rate, making it the most representative procedure for the treatment of severe POP.

[0003] At present, there are two main types of mesh used in clinical pelvic floor reconstruction: one is a polypropylene mesh made of artificial synthetic materials, and the other is a biological patch of acellular tissue matrix. Among them, polypropylene patches have prominent problems such as mesh exposure, erosion, shrinkage, and postoperative pain. In contrast, biological tissue patches have better flexibility, excellent biocompatibility, low immunogenicity, and good anti-infection ability. They have certain advantages in pelvic defect repair and are increasingly widely used in pelvic floor reconstruction. However, the structure of the human pelvic floor is relatively special, and patches used for pelvic floor repair and reconstruction generally require special structural designs. For example, the Hemei pelvic floor repair mesh pelvimesh developed by an Italian instrument manufacturer has a "cross"-shaped model for repairing posterior pelvic prolapse through a gluteal surgical approach. Its horizontal components are slender and its longitudinal components are short and thick; the other model used to treat anterior vaginal wall prolapse is trapezoidal in the middle, with two mesh belts connected to each side. This complex structure poses a high challenge to the preparation of acellular matrix-based biological patches. If the cutting process is used during production, a large amount of scraps will be produced, and the utilization rate of raw materials is very low; if each component is prepared separately and assembled at the end, although the utilization rate of raw materials can be improved, the splicing method of each component becomes a technical bottleneck. Therefore, it is urgent to develop a new pelvic floor patch to solve the above technical problems.

[0004] In view of this, the present utility model is proposed. Utility Model Content

[0005] The purpose of the utility model is to provide a novel pelvic floor patch, which can greatly reduce the generation of scraps and improve the utilization rate of raw materials. After assembly, the holes at the overlapping parts of the patch A and the patch B can guide the soft tissue to grow through, thereby playing an anchoring role similar to that of a suture, preventing the patch A and the patch B from being misaligned. The utility model has broad application prospects and is conducive to popularization and application.

[0006] In order to achieve the above-mentioned purpose, the utility model provides a novel pelvic floor patch, which is assembled from a patch A and a patch B, wherein the patch A is a rectangular structure, and the patch B is a long strip. A slit is provided at each of the two opposite edges of the patch A, and the two ends of the patch B are wide and narrow in the middle, or the two ends are narrow and wide in the middle. The patch B passes through the two slits of the patch A, and its central area is located between the two slits of the patch A. A plurality of holes are provided at the overlapping parts of the patch A and the patch B. The distribution of the holes on the patch A and the patch B is the same. After the patch B passes through the two slits of the patch A, the holes at the overlapping parts of the two completely overlap, and the holes run through the patch A and the patch B. The width of the narrower part of the patch A is not greater than the length of the slit of the patch A, and the width of the wider part is greater than the length of the slit of the patch A.

[0007] Preferably, the holes are arranged in one or more rows, and the distance between each hole is 5-20 mm.

[0008] Preferably, the slit length of the patch A is 0.5-10 cm, and the distance between the slit and the edge is no more than 3 cm.

[0009] Preferably, the total length of the patch B is 20-50 cm.

[0010] Preferably, both the patch A and the patch B are patches made of acellular matrix materials.

[0011] Preferably, the hole is circular, rectangular or a combination of various shapes.

[0012] Preferably, the hole is a circular hole with a diameter of 1-10 mm.

[0013] The utility model provides a novel pelvic floor patch, which has the following beneficial effects.

[0014] 1. The utility model adopts the combination of patch A and patch B, which can greatly reduce the generation of scraps and improve the utilization rate of raw materials.

[0015] 2. The overlapping parts of the patch A and the patch B of the utility model are provided with a plurality of holes, which can guide the soft tissue to grow through the holes after implantation in the body, and the growing soft tissue plays an anchoring role similar to that of sutures to prevent the patch A and the patch B from being misplaced.

[0016] 3. The assembly method of the utility model does not use any additional suturing or bonding materials. It is a new type of acellular matrix material assembly method. In addition to pelvic floor patches, it is also applicable to the assembly and preparation of other surgical patches with complex shapes, and is not limited to the combination of two components. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 A structural schematic diagram of a novel pelvic floor patch provided by the utility model;

[0018] Figure 2 for Figure 1 Schematic diagram of the structure of patch A;

[0019] Figure 3 for Figure 1 Schematic diagram of the structure of patch B;

[0020] Figure 4 Another structural schematic diagram of a novel pelvic floor patch provided by the utility model;

[0021] Figure 5 for Figure 4 Schematic diagram of the structure of patch A;

[0022] Figure 6 for Figure 4 Schematic diagram of the patch B structure.

[0023] In the figure:

[0024] 1. Patch A 2. Patch B 3. Slit 4. Hole. DETAILED DESCRIPTION

[0025] The present invention will be further described below in conjunction with specific embodiments and drawings to help understand the content of the present invention.

[0026] like Figure 1-Figure 3The figures are respectively a schematic diagram of a novel pelvic floor patch provided by the utility model and a schematic diagram of the structure of the patch A and the patch B. The novel pelvic floor patch is assembled by a patch A1 and a patch B2, the patch A1 is a rectangular structure, the patch B2 is a strip, a slit 3 is provided at each of the two opposite edges of the patch A1, the two ends of the patch B2 are wide and the center is narrow, the patch B2 passes through the two slits 3 of the patch A1, and the central area thereof is located between the two slits 3 of the patch A1, and a plurality of holes 4 are provided at the overlapping parts of the patch A1 and the patch B2, the width of the narrower part of the patch A1 is not greater than the length of the slit 3 of the patch A1, and the width of the wider part thereof is greater than the length of the slit 3 of the patch A1. The distribution of the holes 4 on the patch A1 is the same as that on the patch B2. After the patch B2 passes through the two slits 3 of the patch A1, the holes 4 at the overlapping parts of the two completely overlap. The holes 4 run through the patch A1 and the patch B2. The holes 4 are arranged in a row, and the distance between the holes 4 is 5-20 mm. The length of the slit 3 of the patch A1 is 0.5-10 cm, and the distance between the slit 3 and the edge is not more than 3 cm. The total length of the patch B2 is 20-50 cm. Both the patch A1 and the patch B2 are patches of acellular matrix materials. The hole 4 is circular, and can also be a rectangle, other polygons or a combination of various shapes. The hole 4 is a circular hole with a diameter of 1-10 mm.

[0027] like Figure 4-Figure 6 As shown, another structural schematic diagram of a novel pelvic floor patch provided by the utility model and the structural schematic diagrams of the patch A and the patch B. The novel pelvic floor patch is assembled by a patch A1 and a patch B2, the patch A1 is a rectangular structure, the patch B2 is a strip, a slit 3 is provided at each of the two opposite edges of the patch A1, the two ends of the patch B2 are narrow and the center is wide, the patch B2 passes through the two slits 3 of the patch A1, and its central area is located between the two slits 3 of the patch A1, and a plurality of holes 4 are provided at the overlapping parts of the patch A1 and the patch B2, the width of the narrower part of the patch A1 is not greater than the length of the slit 3 of the patch A1, and the width of the wider part is greater than the length of the slit 3 of the patch A1. The distribution of the holes 4 on the patch A1 is the same as that on the patch B2. After the patch B2 passes through the two slits 3 of the patch A1, the holes 4 at the overlapping parts of the two completely overlap. The holes 4 run through the patch A1 and the patch B2. The holes 4 are arranged in multiple rows, and the distance between each hole 4 is 5-20 mm. The length of the slit 3 of the patch A1 is 0.5-10 cm, and the distance between the slit 3 and the edge is not more than 3 cm. The total length of the patch B2 is 20-50 cm. Both the patch A1 and the patch B2 are patches of acellular matrix materials. The hole 4 is circular, and can also be a rectangle, other polygons or a combination of various shapes. The hole 4 is a circular hole with a diameter of 1-10 mm. Example 1

[0028] (1) Preparation of patch A: Acellular bovine dermal matrix was prepared according to the traditional method, and then Figure 2 A rectangular sample is cut as the patch A, and a slit is cut on each of the two opposite edges. The distance between the slit and the edge is 0.5 cm, and the length of the slit is 10 cm.

[0029] (2) Preparation of patch B: Acellular bovine dermal matrix was prepared according to the traditional method, and then Figure 3 The cut long strip sample is shown as patch B, with a total length of 50 cm, a longitudinal width of 8 cm in the narrower part in the center, and a longitudinal width of 12 cm in the wider parts at both ends, wherein the hole in the central part is prepared by punching in the next step.

[0030] (3) Assembly and punching: Pass patch B through the two slits of patch A so that its central area is exactly in the middle of the two slits of patch A. Then use a hole puncher to prepare two rows of holes at the overlapping part of the two. The holes pass through patch A and patch B. The holes are circular with a diameter of 10 mm and a distance of 20 mm between each hole. Example 2

[0031] (1) Preparation of patch A: Acellular porcine dermal matrix was prepared according to the traditional method, and then Figure 2 A rectangular sample is cut as the patch A, and a slit is cut on each of the two opposite edges. The distance between the slit and the length of the slit is 3 cm and 1 cm.

[0032] (2) Preparation of patch B: Acellular porcine dermal matrix was prepared according to the traditional method, and then Figure 3 The cut long strip sample is shown as patch B, which has a total length of 20 cm, a width of 1 cm at the narrower part in the center, and a width of 3 cm at the wider parts at both ends. The hole in the central part is prepared by punching in the next step.

[0033] (3) Assembly and punching: Pass patch B through the two slits of patch A so that its central area is exactly in the middle of the two slits of patch A. Then use a puncher to make a row of holes in the overlapping part of the two patches. The holes pass through patches A and B. The holes are circular with a diameter of 1 mm and a distance of 5 mm between each hole. Example 3

[0034] (1) Preparation of patch A: Acellular porcine bladder matrix was prepared according to the traditional method, and then Figure 1 A rectangular sample is cut as the patch A, and a slit is cut on each of the two opposite edges. The distance between the slit and the length of the slit is 1.5 cm and 5 cm.

[0035] (2) Preparation of patch B: Acellular porcine bladder matrix was prepared according to the traditional method, and then Figure 6 The long strip sample was cut as patch B, with a total length of 35 cm, a width of 7 cm at the wider central part, and a width of 4 cm at the narrower parts at both ends. The hole in the central part was prepared by punching in the next step.

[0036] (3) Assembly and punching: Pass patch B through the two slits of patch A so that its central area is exactly in the middle of the two slits of patch A; then use a hole puncher to prepare three rows of holes at the overlapping part of the two. The holes run through patch A and patch B. The holes are rectangular and circular. The diameter of the circular hole is 3 mm, the side length of the rectangular hole is 3 mm, and the distance between each hole is 7 mm.

[0037] Comparative Example 1

[0038] First, the acellular bovine dermal matrix was prepared according to the method described in Example 1, and then the pelvic floor patch was cut by the traditional cutting method. Then, the raw material utilization rate of the samples prepared in Example 1 and Comparative Example 1 was calculated (raw material utilization rate = finished product area / raw material area). The results were: the raw material utilization rates of Example 1, Example 2, and Example 3 were 67%, 73%, and 64%, respectively, and the raw material utilization rate of Comparative Example 1 was 14%. Therefore, the raw material utilization rate of the utility model is much higher than that of the traditional cutting and cutting method.

[0039] Comparative Example 2

[0040] The pelvic floor patch was prepared in the same manner as in Example 1, with the only difference being that the punching operation in step (3) of Example 1 was deleted in Example 2. Then the samples prepared in Example 1 and Comparative Example 2 were taken, and the patches in the punched areas were cut and implanted subcutaneously on the backs of rats. The animals were killed 4 weeks later, and the tissue ingrowth of the patches was generally observed. The results showed that the punched areas of the sample in Example 1 had soft tissue ingrowth, a large number of new blood vessels grew into the holes, and the double-layer patch had good adhesion, while the double-layer patch of the sample prepared in Comparative Example 2 had obvious dislocation. This experiment proves that the punching method adopted by the utility model can guide the soft tissue to penetrate the ingrowth holes, and the ingrown soft tissue plays an anchoring role similar to that of sutures, preventing the dislocation of patch A and patch B.

[0041] The utility model adopts a combination of patch A and patch B, which can greatly reduce the generation of scraps and improve the utilization rate of raw materials. The overlapping parts of patch A and patch B of the utility model are provided with a plurality of holes, which can guide the soft tissue to grow through the holes after implantation in the body, and the growing soft tissue plays an anchoring role similar to sutures to prevent the dislocation of patch A and patch B. The assembly method of the utility model does not use any additional suturing or adhesive materials. It is a new type of acellular matrix material combination method. In addition to pelvic floor patches, it is also suitable for the assembly and preparation of other surgical patches with complex shapes, and is not limited to the combination of two components.

[0042] This article uses specific examples to explain the concept of the utility model in detail, and the description of the above embodiments is only used to help understand the core idea of ​​the utility model. It should be pointed out that for ordinary technicians in this technical field, any obvious modifications, equivalent substitutions or other improvements made without departing from the concept of the utility model should be included in the scope of protection of the utility model.

Claims

1. A novel pelvic floor patch, characterized in that: It is assembled from patch A and patch B, wherein patch A is a rectangular structure, and patch B is a long strip. A slit is provided at each of the two opposite edges of patch A. Patch B is wide at both ends and narrow in the middle, or narrow at both ends and wide in the middle. Patch B passes through the two slits of patch A, and its central area is located between the two slits of patch A. A number of holes are provided at the overlapping parts of patch A and patch B. The distribution of the holes on patch A and patch B is the same. After patch B passes through the two slits of patch A, the holes at the overlapping parts of the two completely overlap, and the holes run through patch A and patch B. The width of the narrower part of patch A is not greater than the length of the slit of patch A, and the width of the wider part is greater than the length of the slit of patch A.

2. A novel pelvic floor patch according to claim 1, characterized in that: The holes are arranged in one or more rows, and the distance between each hole is 5-20 mm.

3. A novel pelvic floor patch according to claim 2, characterized in that: The slit length of the patch A is 0.5-10 cm, and the distance between the slit and the edge is no more than 3 cm.

4. A novel pelvic floor patch according to claim 3, characterized in that: The total length of the patch B is 20-50 cm.

5. A novel pelvic floor patch according to claim 4, characterized in that: The patch A and the patch B are both patches made of decellularized matrix materials.

6. A novel pelvic floor patch according to claim 5, characterized in that: The hole is circular or rectangular.

7. A novel pelvic floor patch according to claim 6, characterized in that: The hole is a circular hole with a diameter of 1-10 mm.

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