Magnesium alloy rotator cuff patch

Abstract

The invention discloses a magnesium alloy rotator cuff patch. The magnesium alloy rotator cuff patch comprises a main body and a threading part, the main body comprises at least two patch bodies connected in sequence, and every two adjacent patch bodies are rotatably connected so that the included angle between every two adjacent patch bodies can change between 0 degree and 360 degrees; and the threading part is arranged on the sheet body. The magnesium alloy rotator cuff patch not only can be suitable for open surgery, but also can be suitable for arthroscopic surgery, the blood loss amount in the surgery process can be reduced to a certain degree, and the infection risk of a focus part can be reduced to a certain degree.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a magnesium alloy rotator cuff patch. Background Art

[0002] Rotator cuff injury is one of the most common causes of shoulder pain and limited mobility. The incidence of rotator cuff tear in people over 60 years old is about 40%. In recent years, shoulder arthroscopic repair has become the main treatment for rotator cuff injury. Due to the complexity of the etiology of rotator cuff injury, the treatment of rotator cuff disease, especially giant rotator cuff injury, still faces many problems and challenges. For patients with giant rotator cuff tears, the postoperative recurrence rate and re-tear rate can be as high as 50% to 70% if the rotator cuff tear is simply sutured surgically. Another important cause of rotator cuff re-tear is excessive suture tension. In order to solve this problem, in addition to low-tension suture, another commonly used method is rotator cuff patch bridging repair technology. At present, rotator cuff patches can be divided into autologous tendon patches, non-degradable rotator cuff patches, extracellular matrix rotator cuff patches, and synthetic degradable rotator cuff patches.

[0003] At present, magnesium alloy is a new generation of biodegradable materials. Magnesium is one of the essential elements for the human body and is involved in more than 300 enzymatic reactions. It plays an important role in the formation and regeneration of bones. It has active chemical properties and can be completely degraded in the body. Magnesium-based metals also have good mechanical strength and elastic modulus equivalent to cortical bone. They can maintain strong fixation while avoiding poor bone healing caused by stress shielding. In addition, due to its density being similar to that of bone tissue, fewer metal artifacts are produced during imaging examinations. Many studies have also reported that it can promote tendon-bone healing and has antibacterial and anti-tumor effects.

[0004] The magnesium alloy patch in the related prior art is woven into a porous mesh structure from magnesium alloy wires with circular, oval or rectangular (flat strip) cross-sections. The patch cannot be folded and is not suitable for arthroscopic surgery. Only open surgery can be performed, which causes a large wound surface, great trauma, more blood loss, and a correspondingly increased chance of infection, posing a high risk. Summary of the invention

[0005] The main purpose of the present application is to provide a magnesium alloy rotator cuff patch to solve the problem that the magnesium alloy rotator cuff patch in the prior art is not suitable for arthroscopic surgery.

[0006] According to one aspect of the present application, a magnesium alloy rotator cuff patch is provided, comprising:

[0007] A main body, the main body comprising at least two sheets connected in sequence, wherein two adjacent sheets are rotatably connected to each other so that the angle between the two adjacent sheets varies between 0° and 360°;

[0008] A threading portion is disposed on the sheet body.

[0009] Furthermore, the sheet body includes a mesh region and a solid region, and the solid region is arranged at the periphery of the mesh region and is formed integrally with the mesh region.

[0010] Furthermore, the mesh area includes a plurality of mesh holes, and the mesh holes include at least one of circular holes, diamond holes, and square holes.

[0011] Furthermore, at least one of the diameter of the circular hole, the side length of the diamond hole, and the side length of the square hole is 0.8 mm to 10 mm.

[0012] Furthermore, the mesh region includes at least one layer of mesh. When the mesh region includes at least two layers of mesh, mesh holes on at least two layers of mesh are arranged opposite to each other or staggered along the thickness direction of the sheet.

[0013] Furthermore, the mesh region includes a cantilever segment, and the cantilever segment extends in a direction perpendicular to, inclined to, or parallel to the sheet body.

[0014] Furthermore, along the length direction of the cantilever segment, the cross sections at different positions of the cantilever segment are the same or different, wherein the cross section of the cantilever segment is a cross section obtained by cutting the cantilever segment along a direction perpendicular to the length direction of the cantilever segment.

[0015] Further, in two adjacent sheets, the edges of two of the sheets are provided with pins, and the edge of the other sheet is provided with a pin hole matched with the pin; or,

[0016] Two adjacent sheets are rotatably connected via a flexible member.

[0017] Furthermore, the surface of the main body is provided with a hydroxyapatite coating and / or an impregnated hyaluronic acid layer.

[0018] Furthermore, the threading portion includes a threading hole, and the outer periphery of the threading hole is a solid portion.

[0019] In the present application, since the magnesium alloy rotator cuff patch in the present application has at least two sheets connected in sequence, and the adjacent two sheets are rotatably connected, and the angle between the adjacent two sheets in the at least two sheets can vary between 0° and 360°, the at least two sheets can be unfolded to the same plane and can be folded into a predetermined shape. In actual use, the main body can be folded according to the surgical wound, so that the adjacent two sheets overlap or form a certain angle (the size of the angle can be bent according to the actual surgical wound), and then the main body is folded into a predetermined shape to fit the surgical wound well. For example, when the magnesium alloy rotator cuff patch is bent to form a column, the magnesium alloy rotator cuff patch can adapt to a smaller surgical wound; when the magnesium alloy rotator cuff patch is opened to a plane, the magnesium alloy rotator cuff patch can adapt to an open wound. At the same time, after the main body is transported to the lesion site, the main body can be bent according to the bone shape of the lesion site to fit the bone of the lesion site. Thereafter, a threading portion provided on the main body can be used to pass a suture thread or the like through the main body to sew the main body to the rotator cuff.

[0020] That is to say, the magnesium alloy rotator cuff patch in the present application is configured as a plurality of rotatably connected sheets, so that during the operation, the main body can be folded into a predetermined shape to adapt to a smaller surgical wound, and the main body is more suitable for arthroscopic surgery. Compared with the prior art, the magnesium alloy rotator cuff patch in the present application can be applied not only to open surgery but also to arthroscopic surgery, which can reduce the amount of blood loss during the operation to a certain extent, and can reduce the risk of infection at the lesion site to a certain extent. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The drawings described herein are used to provide a further understanding of the present application and constitute a part of the present application. The illustrative embodiments of the present application and their descriptions are used to explain the present application and do not constitute an improper limitation on the present application. In the drawings:

[0022] Figure 1 It is a front view of the magnesium alloy rotator cuff patch disclosed in the embodiment of the present application in an unfolded state;

[0023] Figure 2 It is a three-dimensional structural diagram of the magnesium alloy rotator cuff patch disclosed in the embodiment of the present application when it is in a bent state (with the mesh holes hidden);

[0024] Figure 3 It is a three-dimensional structural diagram of the magnesium alloy rotator cuff patch disclosed in the embodiment of the present application when it is in a bent state (rendered with mesh holes);

[0025] Figure 4 It is a side view of the magnesium alloy rotator cuff patch disclosed in the embodiment of the present application when folded into different shapes;

[0026] Figure 5 It is a partial enlarged view of the first mesh area disclosed in the embodiment of the present application;

[0027] Figure 6 It is a partial enlarged view of the second mesh region disclosed in the embodiment of the present application;

[0028] Figure 7 This is a partially enlarged view of the magnesium alloy rotator cuff patch disclosed in the embodiment of the present application.

[0029] The above drawings include the following reference numerals:

[0030] 10. Main body; 11. Sheet; 111. Mesh area; 1111. Mesh; 1112. Cantilever section; 112. Solid area; 1101. Pin shaft; 1102. Pin hole; 20. Threading part. DETAILED DESCRIPTION

[0031] It should be noted that, in the absence of conflict, the embodiments and features in the embodiments of the present application can be combined with each other. The present application will be described in detail below with reference to the accompanying drawings and in combination with the embodiments.

[0032] It should be noted that the terms used herein are only for describing specific embodiments and are not intended to limit the exemplary embodiments according to the present application. As used herein, unless the context clearly indicates otherwise, the singular form is also intended to include the plural form. In addition, it should be understood that when the terms "comprise" and / or "include" are used in this specification, it indicates the presence of features, steps, operations, devices, components and / or combinations thereof.

[0033] Unless otherwise specifically stated, the relative arrangement, numerical expressions and numerical values ​​of the parts and steps set forth in these embodiments do not limit the scope of the present application. At the same time, it should be understood that, for ease of description, the sizes of the various parts shown in the accompanying drawings are not drawn according to the actual proportional relationship. The technology, methods and equipment known to those of ordinary skill in the relevant art may not be discussed in detail, but in appropriate cases, the technology, methods and equipment should be considered as a part of the authorization specification. In all examples shown and discussed here, any specific value should be interpreted as being merely exemplary, rather than as a limitation. Therefore, other examples of exemplary embodiments may have different values. It should be noted that similar reference numerals and letters represent similar items in the following drawings, and therefore, once a certain item is defined in an accompanying drawing, it does not need to be further discussed in subsequent drawings.

[0034] See also Figures 1 to 7As shown, according to an embodiment of the present application, a magnesium alloy rotator cuff patch is provided. The magnesium alloy rotator cuff patch includes a main body 10 and a threading portion 20 .

[0035] The main body 10 includes at least two sheets 11 connected in sequence, and the two adjacent sheets 11 are rotatably connected to each other so that the angle between the two adjacent sheets 11 varies between 0° and 360°. In other words, the at least two sheets 11 have an unfolded state (such as Figure 1 ) and a bent state in which the bending is in a predetermined shape (as shown in Figure 2 The threading portion 20 is disposed on the sheet body 11 for the suture to pass through during the surgical procedure so as to facilitate the connection and fixation between the sheets 11.

[0036] Since the magnesium alloy rotator cuff patch in the present application has at least two sheets 11 connected in sequence, and the adjacent two sheets 11 are rotatably connected, and the angle between the adjacent two sheets 11 in the at least two sheets 11 can be changed between 0° and 360°, the at least two sheets 11 can be unfolded to the same plane, and can also be folded into a predetermined shape. In actual use, the main body 10 can be folded according to the surgical wound, so that the adjacent two sheets 11 can overlap or form a certain angle (the size of the angle can be bent according to the actual surgical wound), and then the main body 10 is folded into a predetermined shape to fit the surgical wound well. For example, when the magnesium alloy rotator cuff patch is bent into a column, the magnesium alloy rotator cuff patch can adapt to a smaller surgical wound; when the magnesium alloy rotator cuff patch is opened to a plane, the magnesium alloy rotator cuff patch can adapt to an open wound. At the same time, after the main body 10 is delivered to the lesion site, the main body 10 can be bent according to the bone shape of the lesion site so as to fit the bone of the lesion site. Afterwards, through the function of the threading part 20 provided on the main body 10, sutures can be passed through to sew the main body 10 on the rotator cuff.

[0037] That is to say, the magnesium alloy rotator cuff patch in this embodiment is configured as a plurality of sheets 11 rotatably connected together by setting the main body 10, so that during the operation, two adjacent sheets 11 of the main body 10 can be bent at a certain angle, so that the main body 10 can be folded into a predetermined shape to adapt to a smaller surgical wound, and the main body 10 is more suitable for arthroscopic surgery. Compared with the prior art, the magnesium alloy rotator cuff patch in this embodiment can be applied not only to open surgery, but also to arthroscopic surgery, which can reduce the amount of blood loss during the operation to a certain extent, and can reduce the risk of infection at the lesion site to a certain extent.

[0038] When the main body 10 is in the unfolded state, the main body 10 in this embodiment can be arranged in a square sheet shape, or in a circular sheet shape, a rectangular sheet shape, or in other regular or irregular shapes, which can be designed and selected according to the shape of the lesion. Figure 1 FIG. 2 shows a case where the main body 10 is arranged in a rectangular sheet shape when unfolded. When the main body 10 is in a bent state, the cross section of the main body 10 can be arranged in a triangular shape (such as Figure 4 ), or it can be square (as shown in (a) in Figure 4 (b) in the figure), pentagon (as shown in Figure 4 (c) in the figure), regular hexagon (as shown in Figure 4 (as shown in (d) in the figure).

[0039] Furthermore, the sheet 11 in this embodiment includes at least one of a rectangular sheet, an elliptical sheet, and a square sheet. Of course, in other embodiments of the present application, the sheet 11 can also be in other regular or irregular shapes. In actual use, the shape of the sheet 11 can be selected and designed according to the pathological shape of the rotator cuff.

[0040] Furthermore, the sheet 11 includes a mesh area 111 and a solid area 112, and the solid area 112 is arranged at the periphery of the mesh area 111 and is formed integrally with the mesh area 111. In this embodiment, by setting the periphery of the sheet 11 as the solid area 112, that is, the area without mesh holes, the solid area 112 can surround the mesh area 111 inside the solid area 112, so that burrs are not easy to appear on the outside of the sheet 11, and the structural strength and mechanical properties of the sheet 11 can be improved. In the actual operation process, the sheet 11 is not easy to cause damage to the tissue of the lesion. The setting of the mesh area 111 facilitates the subsequent growth and fusion of the tissue of the lesion with the sheet 11.

[0041] Furthermore, the mesh area 111 includes a plurality of mesh holes 1111, and the mesh holes 1111 include at least one of round holes, diamond holes, and square holes. That is to say, the mesh holes 1111 in this embodiment can be set as round holes, diamond holes, square holes, or any combination of round holes, diamond holes, and square holes. Of course, in other embodiments of the present application, the mesh holes 1111 can also be elliptical holes or other regular or irregular holes. Figure 5 The figure shows the situation when the mesh 1111 is a diamond hole. Figure 6 In the figure, the mesh 1111 is other irregular holes. In actual application, the irregular holes are more suitable for the tissue of the lesion site to grow and fuse with the sheet 11, and the regular holes are more suitable for processing and production. The selection and use can be based on the patient's lesion condition.

[0042] Optionally, when the mesh 1111 is set as a circular hole, a diamond hole or a square hole, at least one of the diameter of the circular hole, the side length of the diamond hole and the side length of the square hole is 0.8mm to 10mm, such as 0.8mm, 1mm, 2mm, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm. When the diameter of the circular hole, the side length of the diamond hole and the side length of the square hole are less than 0.8mm, the mesh is relatively small, and the corresponding sheet 11 has more physical structures, which is not convenient for the magnesium alloy rotator cuff patch to degrade; when the diameter of the circular hole, the side length of the diamond hole and the side length of the square hole are greater than 10mm, the mesh 1111 is relatively large, which is not convenient for the tissue at the lesion site to grow and fuse with the sheet 11. That is to say, in this embodiment, by setting the diameter of the circular hole, the side length of the diamond hole and the side length of the square hole to 0.8mm~10mm, it not only facilitates the degradation of the magnesium alloy rotator cuff patch, but also facilitates the growth and fusion of the tissue at the lesion site with the magnesium alloy rotator cuff patch, which can reduce the postoperative recovery time.

[0043] Optionally, the mesh area 111 in the present application includes at least one layer of mesh. When the mesh area 111 includes at least two layers of mesh, the mesh holes 1111 on at least two layers of mesh are arranged opposite to each other or staggered along the thickness direction of the sheet 11. In other words, the mesh area 111 in the present embodiment can be arranged as one layer, or as two layers, three layers, or more than three layers. When the mesh area 111 is arranged as at least two layers, the mesh holes 1111 on the above-mentioned at least two layers of mesh can be arranged opposite to each other, which is convenient for processing and production. Of course, the mesh holes 1111 on the above-mentioned two layers of mesh can also be staggered. When staggered, at least the staggered mesh holes 1111 can be formed by 3D printing, so that the tissue at the lesion site can grow and fuse with the mesh area 111.

[0044] Combination Figure 6 As shown, the mesh region 111 in this embodiment includes a cantilever section 1112, and the cantilever section 1112 extends in a direction perpendicular to, oblique to, or parallel to the sheet body 11. It can be understood that the cantilever section 1112 in this embodiment refers to a structural section that is connected to the mesh region 111 at one end and is freely suspended at the other end. In this embodiment, the cantilever section 1112 is arranged on the mesh region 111, and the cantilever section 1112 can be arranged vertically on the sheet body 11, can be arranged obliquely on the sheet body 11, and can be arranged parallel to the sheet body 11, that is, the cantilever section 1112 can exist on the sheet body 11 in any form, so that it is more suitable for the tissue at the lesion site to grow and fuse with the sheet body 11 as a whole.

[0045] Furthermore, along the length direction of the cantilever section 1112, the cross sections at different positions of the cantilever section 1112 are the same or different, wherein the cross section of the cantilever section 1112 is the cross section obtained by cutting the cantilever section 1112 along the length direction perpendicular to the cantilever section 1112. That is to say, along the length direction of the cantilever section 1112, the thickness of the cantilever section 1112 may be consistent or inconsistent, preferably inconsistent, such a configuration is not only convenient for production and processing, but also convenient for the tissue at the lesion site to grow and fuse with the sheet body 11 quickly, thereby shortening the patient's recovery time after surgery.

[0046] When the main body 10 is actually connected, two adjacent sheets 11 can be connected by a hinge, or by a flexible member such as a pin, a suture, etc. Figure 7 As shown, in the present application, in two adjacent sheets 11, the edge of one sheet 11 is provided with a pin shaft 1101, and the edge of the other sheet 11 is provided with a pin hole 1102 adapted to the pin shaft 1101. In this embodiment, the rotatable connection of the two adjacent sheets 11 is achieved by the cooperation of the pin shaft 1101 and the pin hole 1102, and the structure is simple and easy to assemble. In actual use, the number of sheets 11 can also be selected and disassembled according to the area of ​​the lesion.

[0047] Furthermore, in the present embodiment, a hydroxyapatite coating and / or an impregnated hyaluronic acid layer is provided on the surface of the main body 10. That is to say, a hydroxyapatite coating (HA) layer may be provided on the surface of the main body 10, an impregnated hyaluronic acid layer may be provided, or a hydroxyapatite coating and an impregnated hyaluronic acid layer may be provided at the same time. The provision of a hydroxyapatite coating can promote the growth of bone cells; the provision of an impregnated hyaluronic acid layer can promote the growth of soft tissue at the lesion site. It can be seen that the present application can reduce the patient's postoperative recovery time to a certain extent by providing a hydroxyapatite coating and / or an impregnated hyaluronic acid layer on the surface of the main body 10.

[0048] Furthermore, the threading portion 20 in this embodiment is a threading hole, and the periphery of the threading hole is printed as a solid body using 3D printing technology, has high structural strength, good mechanical properties, and is convenient for sutures to pass through.

[0049] When actually processing the magnesium alloy rotator cuff patch of the present application, 3D printing technology is used to manufacture the magnesium alloy rotator cuff patch under vacuum or nitrogen environment protection. The main body 10 of the magnesium alloy rotator cuff patch is a porous structure, and the threading holes around it are solid printed. The magnesium alloy rotator cuff patch is composed of multiple pieces 11 connected by flexible materials such as hinges or sutures. After connection, the patch can be folded to adapt to minimally invasive operations, and can pass through the arthroscopic access cannula, which is convenient for surgical operations under arthroscopy.

[0050] For ease of description, spatially relative terms such as "above", "above", "on the upper surface of", "above", etc. may be used here to describe the spatial positional relationship between a device or feature and other devices or features as shown in the figure. It should be understood that spatially relative terms are intended to include different orientations of the device in use or operation in addition to the orientation described in the figure. For example, if the device in the accompanying drawings is inverted, the device described as "above other devices or structures" or "above other devices or structures" will be positioned as "below other devices or structures" or "below other devices or structures". Thus, the exemplary term "above" can include both "above" and "below". The device can also be positioned in other different ways (rotated 90 degrees or in other orientations), and the spatially relative descriptions used here are interpreted accordingly.

[0051] In addition, it should be noted that the use of terms such as "first" and "second" to limit components is only for the convenience of distinguishing the corresponding components. Unless otherwise stated, the above terms have no special meaning and therefore cannot be understood as limiting the scope of protection of this application.

[0052] The above are only preferred embodiments of the present application and are not intended to limit the present application. For those skilled in the art, the present application may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A magnesium alloy rotator cuff patch, characterized in that: include: The main body (10) comprises at least two sheets (11) connected in sequence, and two adjacent sheets (11) are rotatably connected to each other so that the angle between the two adjacent sheets (11) is 0°. Change between 360°; A threading portion (20), wherein the threading portion (20) is arranged on the sheet body (11).

2. The magnesium alloy rotator cuff patch according to claim 1, characterized in that: The sheet body (11) comprises a mesh region (111) and a solid region (112); the solid region (112) is arranged at the periphery of the mesh region (111) and is formed integrally with the mesh region (111).

3. The magnesium alloy rotator cuff patch according to claim 2, characterized in that: The mesh area (111) includes a plurality of mesh holes (1111), and the mesh holes (1111) include at least one of circular holes, diamond holes, and square holes.

4. The magnesium alloy rotator cuff patch according to claim 3, characterized in that: At least one of the diameter of the circular hole, the side length of the diamond hole, and the side length of the square hole is 0.8 mm to 10 mm.

5. The magnesium alloy rotator cuff patch according to claim 3, characterized in that: The mesh region (111) includes at least one layer of mesh. When the mesh region (111) includes at least two layers of mesh, along the thickness direction of the sheet (11), the mesh holes (1111) on at least two layers of the mesh are arranged opposite to each other or staggered.

6. The magnesium alloy rotator cuff patch according to claim 2, characterized in that: The mesh region (111) comprises a cantilever section (1112), and the cantilever section (1112) extends in a direction perpendicular to, inclined to, or parallel to the sheet body (11).

7. The magnesium alloy rotator cuff patch according to claim 6, characterized in that: Along the length direction of the cantilever segment (1112), the cross-sections of the cantilever segment (1112) at different positions are the same or different, wherein the cross-section of the cantilever segment (1112) is the cross-section obtained by cutting the cantilever segment (1112) along a direction perpendicular to the length of the cantilever segment (1112).

8. The magnesium alloy rotator cuff patch according to any one of claims 1 to 7, characterized in that: In two adjacent sheets (11), the edges of two of the sheets (11) are provided with pins (1101), and the edge of the other sheet (11) is provided with a pin hole (1102) matched with the pin (1101); or, Two adjacent sheets (11) are rotatably connected via a flexible member.

9. The magnesium alloy rotator cuff patch according to any one of claims 1 to 7, characterized in that: The surface of the main body (10) is provided with a hydroxyapatite coating and / or an impregnated hyaluronic acid layer.

10. The magnesium alloy rotator cuff patch according to any one of claims 1 to 7, characterized in that: The threading portion (20) comprises a threading hole, and the outer periphery of the threading hole is a solid portion.

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