Tissue repair implant and tissue repair kit

Abstract

The present invention relates to the technical field of tissue repair. Disclosed are a tissue repair implant for repairing a bone and / or a cartilage, and a tissue repair kit. The tissue repair implant comprises an insertion main body; the insertion main body comprises a first end surface and a second end surface which are oppositely arranged in an insertion direction of the insertion main body; the insertion main body comprises at least one axial channel extending from the first end surface to the second end surface, and the axial channel is an attachment and migration channel for autologous stem cells and a growth space of new blood vessels. During use, the insertion main body can be implanted into an implantation hole, and the autologous stem cells can migrate upwards to the first end surface along the at least one axial channel, diffuse towards the periphery of the insertion main body in the axial channel, and reach a cartilage layer, thereby promoting regeneration of the cartilage located on the first end surface in the implantation hole and enabling the insertion main body and existing bone tissues around the implantation hole to form a unified whole. Therefore, the tissue repair implant can achieve a stable and good implantation compatibility effect in the implantation hole.

Description

Tissue repair implant and tissue repair kit TECHNICAL FIELD

[0001] The present application relates to the technical field of tissue repair, in particular, to a tissue repair implant for repairing bone and / or cartilage and its derivative forms. BACKGROUND

[0002] Articular cartilage plays a vital role in the normal functioning of synovial joints. Its main functions include providing a smooth surface for movement, i.e. articular cartilage provides a low-friction, smooth surface for joint movement, enabling the bones to slide easily over each other during joint movement. It helps to absorb mechanical stress and distribute the load evenly across the joint, thereby protecting the underlying bone from damage. Articular cartilage covers the ends of long bones, preventing them from rubbing directly against each other, which would not only cause pain and wear but also limit the flexibility of the joint. By reducing friction and providing cushioning, articular cartilage helps to maintain the flexibility of the joint. Damage to articular cartilage can cause joint pain, swelling, limited mobility, deformity, etc. in the hip, knee, ankle, etc., and in severe cases, can result in limb disability, affecting the patient's quality of life. With the increasing aging of the population, articular cartilage damage is becoming more and more common. Therefore, there is an urgent need for clinical repair means for articular cartilage.

[0003] Current means for repairing articular cartilage mainly include drug therapy and surgical treatment. Drug therapy mainly uses collagen and other supplements, but the clinical efficacy is poor. Surgical treatment mainly includes joint replacement, microfracture surgery, and "mosaic" cartilage transplantation surgery. Joint replacement completely replaces the damaged joint with a prosthesis to achieve the purpose of treatment, but the surgery is expensive and there is a risk of prosthesis fracture, poor healing, or prosthesis poisoning. Microfracture surgery is a minimally invasive surgery using an arthroscope. Through the arthroscope, the doctor first removes the calcified cartilage in the joint, then drills small holes in the bone under the cartilage where there is a defect, allowing some bone marrow and blood to seep out of the holes to form a blood clot. This blood clot contains stem cells that can differentiate into cartilage cells. Studies have shown that microfracture technology cannot completely fill the cartilage damage because the generated is fibrocartilage rather than hyaline cartilage. Fibrocartilage has lower mechanical strength than hyaline cartilage and is more compact than hyaline cartilage, so it is more likely to break under the pressure of repeated daily activities than hyaline cartilage. "Mosaic" cartilage transplantation surgery mainly repairs damaged joints by implanting autologous or allogeneic grafts. Autologous grafts can achieve good therapeutic effect, but they cause artificial damage to the healthy side of the patient's joint and cannot repair large area damage to the affected joint. Current allogeneic grafts have the disadvantages of being difficult to obtain, difficult to fuse with bone tissue, high immunogenicity, and potential risk of disease transmission.

[0004] Therefore, there is an urgent need for a tissue repair implant capable of forming a good and stable implant compatibility effect. SUMMARY

[0005] In a first aspect, the purpose of the present application is to provide a tissue repair implant for repairing bone and / or cartilage, which can form a stable and good implant compatibility effect in the implant hole of the bone and / or cartilage, so as to improve the topographic matching with the surrounding tissue, accelerate the recovery of tissue function, and promote the morphological reconstruction.

[0006] In order to achieve the above-mentioned purpose, the present application provides a tissue repair implant for repairing bone and / or cartilage, which comprises an insertion main body, the insertion main body comprising a first end face and a second end face oppositely arranged along the insertion direction thereof, wherein the insertion main body comprises at least one axial channel extending from the first end face to the second end face.

[0007] In this technical solution, since the insertion main body comprises a first end face and a second end face oppositely arranged along the insertion direction thereof, and comprises at least one axial channel extending from the first end face to the second end face. In actual use, the operator can implant the insertion main body or the insertion main body arranged with biocompatible material into the implant hole of the bone and / or cartilage along the insertion direction, or cover the biocompatible material onto the first end face of the insertion main body after implantation. The autologous stem cells will migrate to the first end face along the at least one axial channel and diffuse to the surrounding inside the insertion main body in the axial channel, so that the insertion main body forms a unified whole with the original bone tissue around the implant hole, and therefore the tissue repair implant can form a stable and good implant compatibility effect in the implant hole, so as to improve the topographic matching with the surrounding tissue, accelerate the recovery of tissue function, and promote the morphological reconstruction.

[0008] In some embodiments, the diameter of the axial channel is 0.2-0.75mm.

[0009] In some embodiments, the diameter of the axial channel is 0.3-0.5mm.

[0010] In some embodiments, the number of axial channels is multiple, and the axial channel extending at the central position of the insertion main body is included.

[0011] In some embodiments, the inner diameter of the axial channel at the central position is the same as or different from the inner diameter of the axial channel at other positions. For example, in some embodiments, the inner diameter of the axial channel at the central position is greater than the inner diameter of the axial channel at other positions.

[0012] In some embodiments, the insertion main body is a cylinder.

[0013] In some embodiments, the insertion body comprises a cylindrical segment having the first end face and a frustoconical segment having the second end face, wherein a large diameter end of the frustoconical segment is connected to the cylindrical segment, and a small diameter end of the frustoconical segment is distal to the cylindrical segment.

[0014] In some embodiments, the angle of inclination of the outer lateral surface of the frustoconical segment at any position is 0.5°-30°.

[0015] In some embodiments, the angle of inclination is 0.5°-20°. In some embodiments, the angle of inclination is 0.5°-10°. In some embodiments, the angle of inclination is 0.5°-5°. In some embodiments, the angle of inclination is 1°-2°.

[0016] In some embodiments, the insertion body is a coralline body.

[0017] In some embodiments, the tissue repair implant further comprises a layer of biocompatible material extending from the first end face.

[0018] In some embodiments, the tissue repair implant further comprises a biocompatible material in the form of a hydrogel, capable of being placed on the first end face of the insertion body.

[0019] In some embodiments, the tissue repair implant has a diameter of 6-15 mm and a length of 8-15 mm.

[0020] In some embodiments, the tissue repair implant has a diameter of 8-12 mm and a length of 9-14 mm.

[0021] In a second aspect, the present application provides a tissue repair kit, comprising a tissue repair tool and a tissue repair implant according to any of the above first aspect. BRIEF DESCRIPTION OF DRAWINGS

[0022] For better understanding of the above objects, features and advantages of the present application, reference should be made to the preferred embodiments thereof, as shown in the accompanying drawings. The same or similar reference numerals in different drawings denote the same or similar components. It is to be understood that the drawings are schematically illustrating the preferred embodiments of the present application, and the scope of the present application is not limited by the drawings in any way, and the components in the drawings are not drawn to scale.

[0023] Fig. 1 is a perspective view of a first tissue repair implant according to an embodiment of the present application.

[0024] Fig. 2 is a perspective view of a second tissue repair implant according to an embodiment of the present application.

[0025] Fig. 3 is a perspective view of a third tissue repair implant according to embodiments of the present application.

[0026] Fig. 4 is a side view of a tissue repair implant according to embodiments of the present application.

[0027] Fig. 5 is a side view of a tissue repair implant according to embodiments of the present application, wherein the dashed line indicates an axial channel extending from the first end face to the second end face within the insertion body.

[0028] BRIEF DESCRIPTION OF DRAWINGS 1 - first end face, 2 - second end face, 3 - insertion body, 4 - axial channel, 5 - cylindrical section, 6 - frustoconical section, 7 - layer of biocompatible material, 8 - tissue repair implant. DETAILED DESCRIPTION

[0029] In the following detailed description of implementations, reference is made to the accompanying drawings that form a part hereof, and in which are shown, by way of illustration, specific embodiments in which the application can be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the application, and it is to be understood that other embodiments can be utilized and that structural, logical, and electrical changes can be made without departing from the scope of the present application. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present application is defined by the appended claims.

[0030] In a first aspect, with reference to Figs. 1, 2, 3, 4 and 5, embodiments of the present application provide a tissue repair implant 8 for repairing bone and / or cartilage, the tissue repair implant 8 comprising an insertion body 3 for insertion into an implantation hole, the insertion body 3 comprising a first end face 1 and a second end face 2 arranged opposite along an insertion direction of the insertion body 3, wherein the insertion body 3 comprises at least one axial channel 4 extending from the first end face 1 to the second end face 2.

[0031] In the tissue repair implant 8, since the insertion body 3 comprises the first end face 1 and the second end face 2 oppositely arranged along the insertion direction thereof, the first end face 1 is configured to be capable of placing any biocompatible material, and the insertion body 3 comprises at least one axial channel 4 extending from the first end face 1 to the second end face 2. The axial channel 4 can serve as a self-stem cell adhesion and migration channel and a new blood vessel growth space. In actual use, the operator can implant the insertion body or the insertion body arranged with the biocompatible material into the implant hole along the insertion direction, or cover the biocompatible material onto the first end face of the insertion body after implantation. The self-stem cells will migrate along the at least one axial channel 4 to the first end face 1 (for example, upward) at the first end face 1, and diffuse in the axial channel 4 to the periphery of the insertion body and reach the cartilage layer, thereby promoting the cartilage regeneration on the first end face in the implant hole, and making the insertion body form a unified whole with the original bone tissue around the implant hole, so that the tissue repair implant can form a stable and good implant compatibility effect in the implant hole, improve the topography matching with the surrounding tissue, accelerate the recovery of tissue function, and promote the morphological reconstruction thereof.

[0032] In the tissue repair implant 8, the diameter of the axial channel 4 can be selected according to actual needs. For example, in some embodiments, the diameter of the axial channel 4 is 0.2 mm-0.75 mm. In some embodiments, the diameter of the axial channel 4 is 0.3 mm-0.5 mm. In some embodiments, the diameter of the axial channel 4 is 0.4 mm. However, it should be understood that the diameter of the axial channel 4 is not limited thereto, and can be other values outside the range, for example, the diameter of the axial channel 4 can also be 0.2 mm, 0.6 mm or other values, such as 1.0 mm.

[0033] In addition, in the tissue repair implant 8, the number of axial channels 4 can be selected according to actual needs. For example, in some embodiments, the number of axial channels 4 can be selected according to the diameter of the insertion body 3. In addition, the plurality of axial channels 4 can have various arrangements on the first end face 1, and the tissue repair implant 8 of the present application includes but is not limited to the following described arrangement. For example, in some embodiments, referring to FIGS. 1, 2, 4 and 5, the number of axial channels 4 is multiple, for example, 7 axial channels 4 as shown in the drawings, and the axial channel 4 extending at the center position of the insertion body 3, and the other axial channels 4 can be arranged one or more circles around the axial channel 4 at the center position. In this way, the self-stem cells can uniformly diffuse to the periphery of the insertion body 3 along the axial channel 4 at the center position.

[0034] In addition, in the tissue repair implant 8, in some embodiments, each axial channel 4 can have the same inner diameter. Alternatively, in some embodiments, each axial channel 4 can have different inner diameters. Alternatively, in some embodiments, some axial channels 4 can have the same inner diameter, and some axial channels 4 can have different inner diameters. For example, in some embodiments, the inner diameter of the axial channel 4 at the center position is different from the inner diameter of the axial channel 4 at other positions. For example, the inner diameter of the axial channel 4 at the center position is larger than the inner diameter of the axial channel 4 at other positions, so that the axial channel 4 at the center position has a larger inner diameter to further facilitate the uniform diffusion of autologous stem cells around the insertion body 3. Alternatively, the inner diameters of the axial channels 4 at other positions can be the same or different.

[0035] In addition, the tissue repair implant 8 of the present application can have various different shapes. The tissue repair implant 8 can include some predetermined shapes, but is not limited to these predetermined shapes. For example, the tissue repair implant 8 can be a plate, a disc, a cube, or a screw, etc. For example, in some embodiments, referring to FIG. 1, the insertion body 3 is a cylinder. The diameter and length of the cylinder can be selected according to actual needs, including but not limited to the diameter and length values provided below. For example, in some embodiments, the diameter of the cylinder is 6-15 mm, and the length is 8-15 mm. In some embodiments, the diameter of the cylinder is 8-12 mm, and the length is 9-14 mm. In some embodiments, the diameter of the cylinder is 10 mm, and the length is 10 mm.

[0036] In other embodiments, referring to FIGS. 2 and 5, the insertion body 3 includes a cylindrical segment 5 having a first end surface 1 and a frustoconical segment 6 having a second end surface 2, wherein the large diameter end of the frustoconical segment 6 is connected to the cylindrical segment 5, and the small diameter end of the frustoconical segment 6 is away from the cylindrical segment 5. Since the diameter of the frustoconical segment 6 gradually decreases in the direction away from the cylindrical segment 5, the inclined outer peripheral surface of the frustoconical segment 6 can facilitate the insertion of the insertion body 3 into the implant hole. In addition, when the implant hole is a cylindrical hole, the inclined outer peripheral surface of the frustoconical segment 6 will form an annular cavity with the inner peripheral surface of the implant hole, which can accommodate biocompatible material, thereby facilitating the reliable positioning and effective compatibility of the insertion body 3 in the implant hole.

[0037] In addition, the angle of inclination of the outer surface of the frustoconical section 6 can be selected according to the actual needs, including but not limited to the following angle values. For example, in some embodiments, the angle of inclination of the outer surface of the frustoconical section 6 at any position is 0.5°-30°. This angle range, while facilitating the insertion of the body 3 into the implant hole, can also keep the above-mentioned annular cavity within a reasonable size range, so that the insertion body 3 fills the implant hole as much as possible. In some embodiments, the angle of inclination is 0.5°-20°. In some embodiments, the angle of inclination is 0.5°-10°. In some embodiments, the angle of inclination is 0.5°-5°. In some embodiments, the angle of inclination is 1°-2°.

[0038] In addition, in the tissue repair implant 8, the insertion body 3 can be any bone repair material, including but not limited to a high-porosity bone repair material. For example, in some embodiments, the insertion body 3 is a coral body, so that the self-connected porous structure of the coral body and at least one axial channel, especially the plurality of axial channels, cooperate to enable autologous stem cells to expand more evenly into the coral body, further expanding to the first end surface, so that the coral body is more easily integrated with the bone tissue and cartilage tissue around the implant hole. In addition, the coral body can be a pure coral body or a coral body subjected to a desired processing step.

[0039] In addition, in other embodiments, referring to FIG. 3, the tissue repair implant 8 of the present application further comprises a biocompatible material layer 7 extending from the first end surface 1, which can be made of any desired biocompatible material, such as a collagen layer or a polylactic acid polymer layer. The biocompatible material layer 7 can be arranged only on the first end surface 1, or extend a predetermined distance from the first end surface 1 towards the second end surface 2. In addition, the biocompatible material layer 7 can enter the axial channel 4.

[0040] In addition, in some embodiments, the tissue repair implant further comprises a biocompatible material in the form of a hydrogel to be placed on the first end surface of the insertion body. For example, the biocompatible material in the form of a hydrogel can be packaged separately to form a matching accessory, which, when used, can be covered on the first end surface of the insertion body after the insertion body is implanted into the implant hole.

[0041] In addition, the diameter and length of the tissue repair implant in some embodiments can be selected according to actual needs, including but not limited to the following provided diameter and length values. For example, in some embodiments, the diameter of the tissue repair implant is 6-15 mm, and the length is 8-15 mm. In some embodiments, the diameter of the tissue repair implant is 8-12 mm, and the length is 9-14 mm. In some embodiments, the diameter of the tissue repair implant is 10 mm, and the length is 10 mm.

[0042] In a second aspect, the present application provides a tissue repair kit for repairing bone and / or cartilage, the tissue repair kit comprising a tissue repair tool, which can include but is not limited to a cartilage and bone removal tool and a tissue repair material pusher, such as a drill bit, a sleeve drill bit, a knife, a Kirschner wire, a syringe with a syringe needle, etc.; and the tissue repair implant 8 according to any of the above first aspect. In this way, the operator can conveniently use the tissue repair kit to form an implant hole and reliably implant the tissue repair implant 8 into the implant hole to achieve the desired good and stable tissue repair purpose.

[0043] In addition, the tissue repair kit can include ancillary products required for tissue repair, including but not limited to collagen gel products. In addition, any ancillary tissue repair tool can use existing various required tools.

[0044] In addition, the method of using or operating the tissue repair implant 8 of the present application is as follows:

[0045] providing or preparing a tissue repair implant, the tissue repair implant being the tissue repair implant 8 according to any of the above, that is, the tissue repair implant comprising an insertion body 3, the insertion body 3 comprising a first end face 1 and a second end face 2 oppositely arranged along an insertion direction thereof, the insertion body 3 comprising at least one axial channel 4 extending from the first end face 1 to the second end face 2;

[0046] The operator implants the insertion body of the tissue repair implant thus provided or prepared into an implant hole of a bone repair area (for example, an osteoarthritis, bone disorder, osteochondral defect or cartilage injury area) along the insertion direction, so that the autologous stem cells will migrate along the at least one axial channel 4 to the first end face 1 (for example, upward) to the first end face 1 and diffuse in the axial channel 4 to the surrounding inside the insertion body and reach the cartilage layer, thereby promoting the cartilage regeneration on the first end face in the implant hole and forming a unified whole with the original bone tissue around the implant hole.

[0047] In some embodiments, the operator can implant the insertion body arranged with the biocompatible material into the implantation hole along the insertion direction, or the operator can cover the biocompatible material onto the first end surface of the insertion body after the insertion body is inserted into the implantation hole.

[0048] In some embodiments, the biocompatible material can include a natural polymer, which can include glycosaminoglycans, collagen, fibrin, elastin, silk, chitosan, alginate, calcium alginate, cross-linked calcium alginate, cross-linked chitosan, hyaluronic acid, sodium hyaluronate, cross-linked hyaluronic acid, and any combination thereof.

[0049] In some embodiments, the tissue repair implant 8 can further include a cytokine, a growth factor, a therapeutic compound, a drug, a cell population, or any combination thereof.

[0050] In some embodiments, the insertion body includes a coral or a coral derivative, which mainly includes aragonite, calcite, hydroxyapatite, or a combination thereof.

[0051] In some embodiments, the tissue repair implant 8 can be in contact with a protein-containing, salt-containing, or carbohydrate-containing solution, or can be in contact with a biological liquid or a blood analogue or a synthetic blood analogue.

[0052] It should be understood by those skilled in the art that the above embodiments are exemplary and non-limiting. Different technical features appearing in different embodiments can be combined to achieve beneficial effects. Based on the drawings, the specification, and the claims, those skilled in the art should understand and implement other changed embodiments of the disclosed embodiments. Any reference signs in the claims should not be understood as limiting the scope of protection. The fact that certain technical features appear in different dependent claims does not mean that these technical features cannot be combined to achieve beneficial effects.

Claims

1. A tissue repair implant, characterized in that: The tissue repair implant is used to repair bone and / or cartilage, and comprises an insertion body (3), wherein the insertion body (3) comprises a first end face (1) and a second end face (2) arranged opposite to each other along its insertion direction, wherein the insertion body (3) comprises at least one axial channel (4) extending from the first end face (1) to the second end face (2).

2. The tissue repair implant according to claim 1, characterized in that The diameter of the axial channel (4) is 0.2-0.75 mm.

3. The tissue repair implant according to claim 1, characterized in that The number of the axial channels (4) is plural, and includes an axial channel (4) extending at the center position of the insertion body (3).

4. The tissue repair implant according to claim 3, characterized in that The inner diameter of the axial channel (4) at the center position is the same as or different from the inner diameters of the axial channels (4) at other positions.

5. The tissue repair implant according to any one of claims 1 to 4, characterized in that: The inserting body (3) is a cylinder.

6. The tissue repair implant according to any one of claims 1 to 4, characterized in that: The insert body (3) comprises a cylindrical section (5) having the first end face (1) and a truncated cone section (6) having the second end face (2), wherein the large diameter end of the truncated cone section (6) is connected to the cylindrical section (5), and the small diameter end of the truncated cone section (6) is away from the cylindrical section (5).

7. The tissue repair implant according to claim 6, characterized in that: The inclination angle at any position of the outer surface of the truncated cone segment (6) is 0.5°-30°.

8. The tissue repair implant according to any one of claims 1 to 7, characterized in that: The insertion body (3) is a coral body.

9. The tissue repair implant according to any one of claims 1 to 8, characterized in that: The tissue repair implant (8) further comprises a biocompatible material layer (7) extending from the first end surface (1).

10. The tissue repair implant according to claim 1, characterized in that The tissue repair implant has a diameter of 6-15 mm and a length of 8-15 mm.

11. A tissue repair kit, characterized in that: It comprises a tissue repair tool; and a tissue repair implant (8) according to any one of claims 1-10.

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