Tissue repair implant and tissue repair kit

Abstract

The utility model relates to the technical field of tissue repair, and discloses a tissue repair implant and a tissue repair set for repairing bones and / or cartilages. The tissue repair implant comprises an insertion body, the insertion body comprises a first end face and a second end face which are oppositely arranged in the insertion direction of the insertion body, the insertion body comprises at least one axial channel extending from the first end face to the second end face, and the axial channels are an autologous stem cell attachment migration channel and a new vessel growth space. In use, the insertion main body can be implanted into the implantation hole, and autologous stem cells can migrate upwards to the first end face along the at least one axial channel, diffuse towards the periphery in the insertion main body in the axial channel and reach a cartilage layer; therefore, cartilage located on the first end face in the implantation hole is promoted to be regenerated, and the insertion body and original bone tissue around the implantation hole form a unified whole. Therefore, the tissue repair implant can form a stable and good implantation compatibility effect in the implantation hole.

Description

Technical Field

[0001] The utility model relates to the technical field of tissue repair, in particular to a tissue repair implant for repairing bones and / or cartilage and a derivative form thereof. Background Art

[0002] Articular cartilage is an important part of the knee joint movement system. When running or jumping, articular cartilage is like a sponge covering the bones, which plays a role in cushioning and absorbing shock. This not only makes the joints more flexible, but also reduces the discomfort caused by direct collision of bones and avoids mechanical damage to the bones. Articular cartilage damage can cause joint pain, swelling, limited movement, deformity, etc. in the hip, knee, ankle and other parts. In severe cases, it can cause limb disability and affect the patient's quality of life. With the aging of the population, articular cartilage damage is becoming more and more common. Therefore, there is an urgent need for methods to repair articular cartilage in clinical practice.

[0003] At present, the means of repairing articular cartilage are mainly divided into drug treatment and surgical treatment. Drug treatment mainly uses supplements such as collagen, and the clinical efficacy is poor. Surgical treatment is mainly divided into joint replacement, microfracture surgery and "mosaic" cartilage transplantation. Joint replacement achieves the purpose of treatment by using a prosthesis to completely replace the damaged joint, but the cost of surgery is high and there are risks such as prosthesis breakage, poor healing or prosthesis poisoning. Microfracture surgery is a minimally invasive surgery performed using arthroscopy. Through arthroscopy, the doctor first removes the calcified cartilage in the joint, and then drills a small hole in the bone under the cartilage at the location where the cartilage is defective, so that part of the bone marrow and blood seeps out of the hole to form a blood clot. This blood clot contains stem cells, which can differentiate into cells that form cartilage. Studies have shown that microfracture technology cannot completely fill cartilage damage because fibrocartilage is generated instead of hyaline cartilage. The mechanical strength of fibrocartilage is not as high as hyaline cartilage, and it is denser than hyaline cartilage, so it is more easily broken than hyaline cartilage under the pressure of repeated daily activities. The "Mosaic" cartilage transplantation surgery mainly repairs damaged joints by implanting autologous or allogeneic grafts. Although autologous grafts can achieve good therapeutic effects, they cause artificial damage to the articular cartilage on the healthy side of the patient and cannot repair large-area damage to the affected joint. The current allogeneic grafts are difficult to fuse with bone tissue, have high immunogenicity, and have the potential risk of spreading diseases.

[0004] Therefore, there is an urgent need for a tissue repair implant that can form a good and stable implant compatibility effect. Utility Model Content

[0005] On the first aspect, the purpose of the utility model is to provide a tissue repair implant for repairing bone and / or cartilage, which tissue repair implant can form a stable and good implant compatibility effect in the implantation hole of bone and / or cartilage to improve the morphological matching with the surrounding tissue, accelerate the recovery of tissue function, and promote its morphological reconstruction.

[0006] In order to achieve the above-mentioned objectives, the utility model provides a tissue repair implant, which is used to repair bone and / or cartilage. The tissue repair implant includes an insertion body, and the insertion body includes a first end face and a second end face arranged opposite to each other along its insertion direction, wherein the insertion body includes at least one axial channel extending from the first end face to the second end face.

[0007] In this technical solution, since the insertion body includes a first end face and a second end face arranged relative to each other along its insertion direction, and includes 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 body or the insertion body arranged with a biocompatible material into the implantation hole of the bone and / or cartilage along the insertion direction, or cover the biocompatible material on the first end face of the insertion body after implantation. Autologous stem cells will migrate toward the first end face along at least one axial channel, and diffuse around the insertion body in the axial channel, so that the insertion body and the original bone tissue around the implantation hole form a unified whole. Therefore, the tissue repair implant can form a stable and good implantation compatibility effect in the implantation hole to enhance the morphological matching with the surrounding tissues, accelerate the recovery of tissue function, and promote its morphological reconstruction.

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

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

[0010] In some embodiments, the axial passages are multiple in number and include an axial passage extending at a central position of the insertion body.

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

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

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

[0014] In some embodiments, the inclination angle at any position of the outer surface of the truncated cone segment 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 coral body.

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

[0018] In some embodiments, the tissue repair implant further comprises a biocompatible material in the form of a hydrogel so as to be positionable on the first end surface 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 invention provides a tissue repair kit, which includes a tissue repair tool and a tissue repair implant according to any one of the above first aspects. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] In order to better understand the above and other purposes, features, advantages and functions of the present invention, reference may be made to the preferred embodiments shown in the accompanying drawings. The same or similar reference numerals in the accompanying drawings refer to the same or similar components. It should be understood by those skilled in the art that the accompanying drawings are intended to schematically illustrate the preferred embodiments of the present invention and have no limiting effect on the scope of the present invention, and the components in the drawings are not drawn to scale.

[0023] Figure 1 It is a schematic diagram of the three-dimensional structure of the first tissue repair implant provided by the specific embodiment of the utility model.

[0024] Figure 2 It is a schematic diagram of the three-dimensional structure of a second tissue repair implant provided by a specific embodiment of the utility model.

[0025] Figure 3 It is a schematic diagram of the three-dimensional structure of a third tissue repair implant provided by a specific embodiment of the utility model.

[0026] Figure 4 It is a schematic end view of a tissue repair implant provided by a specific embodiment of the utility model.

[0027] Figure 5 It is a side view schematic diagram of a tissue repair implant provided by a specific embodiment of the utility model, wherein the dotted line represents an axial channel extending from the first end surface to the second end surface in the insertion body.

[0028] Description of Reference Numerals

[0029] 1-first end face, 2-second end face, 3-insertion body, 4-axial channel, 5-cylindrical section, 6-frustum section, 7-biocompatible material layer, 8-tissue repair implant. DETAILED DESCRIPTION

[0030] In the following detailed description of the embodiments, reference is made to the accompanying drawings that constitute a part of the description. The accompanying drawings illustrate specific embodiments by way of example, in which the utility model is implemented. The embodiments shown are not intended to be exhaustive of all embodiments according to the utility model. It is understood that other embodiments can be utilized, and structural or logical changes can be made without departing from the scope of the utility model. For the drawings, directional terms, such as "bottom", "top", "left", "right", etc., are used with reference to the orientation of the drawings described. Since the components of the embodiments of the utility model can be implemented in a variety of orientations, these directional terms are used for illustrative purposes rather than for limiting purposes. Therefore, the following specific embodiments are not intended to be limiting, and the scope of the utility model is defined by the appended claims.

[0031] First, refer to Figure 1 , Figure 2 , Figure 3 , Figure 4 and Figure 5 The tissue repair implant 8 provided in a specific embodiment of the utility model is used to repair bones and / or cartilage. The tissue repair implant 8 includes an insertion body 3, which is used to be inserted into an implantation hole. The insertion body 3 includes 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 includes at least one axial channel 4 extending from the first end face 1 to the second end face 2.

[0032] In the tissue repair implant 8, since the insertion body 3 includes a first end face 1 and a second end face 2 arranged relatively along its insertion direction, the first end face 1 is configured to place any biocompatible material and the body 3 includes 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 an autologous stem cell attachment 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 implantation hole along the insertion direction, or cover the biocompatible material on the first end face of the insertion body after implantation. The autologous stem cells will migrate to the first end face 1 along at least one axial channel 4 (for example, upward) and diffuse around the insertion body in the axial channel 4 and reach the cartilage layer, thereby promoting the regeneration of cartilage on the first end face in the implantation hole, and making the insertion body and the original bone tissue around the implantation hole form a unified whole, so that the tissue repair implant can form a stable and good implantation compatibility effect in the implantation hole to improve the morphological matching with the surrounding tissues, accelerate the recovery of tissue function, and promote its morphological reconstruction.

[0033] 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 0.2mm-0.75mm. In some embodiments, the diameter of the axial channel 4 is 0.3mm-0.5mm. In some embodiments, the diameter of the axial channel 4 is 0.4mm. However, it should be understood that the diameter of the axial channel 4 is not limited thereto, and it can be other values ​​outside this range, for example, the diameter of the axial channel 4 can also be 0.2mm, 0.6mm or other values, such as 1.0mm.

[0034] 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 insert body 3. In addition, the plurality of axial channels 4 can have a variety of arrangements on the first end surface 1. The tissue repair implant 8 of the present invention includes but is not limited to an arrangement described below. For example, in some embodiments, reference Figure 1 , Figure 2 , Figure 4 and Figure 5 The number of the axial channels 4 is multiple, for example, 7 axial channels 4 are shown in the figure, and include the axial channel 4 extending at the center of the insert body 3, and the other axial channels 4 can be arranged in one or more circles around the axial channel 4 at the center. In this way, the autologous stem cells can be uniformly diffused along the axial channel 4 at the center to the surroundings of the insert body 3.

[0035] In addition, in the tissue repair implant 8, in some embodiments, each axial channel 4 may have the same inner diameter. Alternatively, in some embodiments, each axial channel 4 may have different inner diameters. Alternatively, in some embodiments, some axial channels 4 may have the same inner diameter, and other axial channels 4 may 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 diameters of the axial channels 4 at other positions. For example, the inner diameter of the axial channel 4 at the center position is larger than the inner diameters of the axial channels 4 at other positions. In this way, since the axial channel 4 at the center position has a larger inner diameter, it is further convenient for the autologous stem cells to diffuse evenly around the insertion body 3. Optionally, the inner diameters of the axial channels 4 at other positions may be the same or different.

[0036] In addition, the tissue repair implant 8 of the present invention can have a variety of 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 plate-shaped, disc-shaped, cube-shaped or screw-shaped, etc. For example, in some embodiments, reference Figure 1 , the insert 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 6-15mm and the length is 8-15mm. In some embodiments, the diameter of the cylinder is 8-12mm and the length is 9-14mm. In some embodiments, the diameter of the cylinder is 10mm and the length is 10mm.

[0037] In some other embodiments, reference Figure 2 and Figure 5 , the insertion body 3 includes a cylindrical section 5 with a first end face 1 and a truncated cone section 6 with a 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. Since the diameter of the truncated cone section 6 gradually decreases in the direction away from the cylindrical section 5, the inclined outer circumferential surface of the truncated cone section 6 can facilitate the insertion body 3 to be inserted into the implant hole. In addition, when the implant hole is a cylindrical hole, an annular cavity will be formed between the inclined outer circumferential surface of the truncated cone section 6 and the inner circumferential surface of the implant hole, and the annular cavity can accommodate biocompatible materials, thereby making it easier to reliably position and effectively compatibly with the insertion body 3 in the implant hole.

[0038] In addition, the inclination angle of the outer surface of the frustum of the cone segment 6 can be selected according to actual needs, and the inclination angle includes but is not limited to the angle values ​​provided below. For example, in some embodiments, the inclination angle of any position on the outer surface of the frustum of the cone segment 6 is 0.5°-30°. This angle range can facilitate the insertion of the insertion body 3 into the implantation hole while keeping the above-mentioned annular cavity within a reasonable size range, so that the insertion body 3 can fill the implantation hole as much as possible. In some embodiments, the inclination angle is 0.5°-20°. In some embodiments, the inclination angle is 0.5°-10°. In some embodiments, the inclination angle is 0.5°-5°. In some embodiments, the inclination angle is 1°-2°.

[0039] In addition, in the tissue repair implant 8, the insert body 3 can be any bone repair material, including but not limited to bone repair materials with high porosity. For example, in some embodiments, the insert body 3 is a coral body, so that the porous structure of the coral body itself and at least one axial channel, especially the cooperation of multiple axial channels, can make the autologous stem cells more evenly expand into the coral body, so that the coral body is easier to fuse with the bone tissue around the implant hole. In addition, the coral body can be a pure coral body or a coral body that has undergone the required processing steps.

[0040] In addition, in some other embodiments, reference Figure 3 The tissue repair implant 8 of the present invention further includes a biocompatible material layer 7 extending from the first end face 1. The biocompatible material layer 7 may be made of any desired biocompatible material, for example, the biocompatible material layer 7 may include but is not limited to a collagen layer or a polylactic acid polymer layer. The biocompatible material layer 7 may be arranged only on the first end face 1, or extend a predetermined distance from the first end face 1 toward the second end face 2. In addition, the biocompatible material layer 7 may enter the axial channel 4.

[0041] In addition, in some embodiments, the tissue repair implant further comprises a biocompatible material in the form of a hydrogel, so that it can 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, and in use, after the insertion body is implanted in the implant hole, the biocompatible material in the form of a hydrogel can be covered on the first end surface of the insertion body.

[0042] In addition, in some embodiments, the diameter and length of the tissue repair implant 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 tissue repair implant is 6-15mm and the length is 8-15mm. In some embodiments, the diameter of the tissue repair implant is 8-12mm and the length is 9-14mm. In some embodiments, the diameter of the tissue repair implant is 10mm and the length is 10mm.

[0043] In a second aspect, the utility model provides a tissue repair kit, which is used to repair bone and / or cartilage, and includes a tissue repair tool, which may include but is not limited to a cartilage and bone removal tool and a tissue repair material pusher, such as a syringe with an injection needle; and a tissue repair implant 8 according to any of the above first aspects. 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.

[0044] In addition, the tissue repair kit may include accessory products required for tissue repair, and the accessory products include but are not limited to collagen gel products. In addition, any accessory tissue repair tool may use various existing required tools.

[0045] In addition, the method of using or operating the tissue repair implant 8 of the present invention is as follows:

[0046] Providing or preparing a tissue repair implant, which is any of the tissue repair implants 8 described above, that is, the tissue repair implant comprises an insertion body 3, 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, 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;

[0047] The operator implants the insertion body of the provided or prepared tissue repair implant into the implant hole of the bone repair area (e.g., osteoarthritis, bone disorder, osteochondral defect or cartilage damage area) along the insertion direction, so that the autologous stem cells will migrate along at least one axial channel 4 toward the first end face 1 (e.g., upward) to the first end face 1, and diffuse to the surrounding areas of the insertion body in the axial channel 4 and reach the cartilage layer, thereby promoting the regeneration of cartilage on the first end face in the implant hole, and allowing the insertion body and the original bone tissue around the implant hole to form a unified whole.

[0048] In some embodiments, the operator may implant the insertion body arranged with the biocompatible material into the implantation hole along the insertion direction, or the operator may cover the biocompatible material onto the first end surface of the insertion body after the insertion body is inserted into the implantation hole.

[0049] In some embodiments, the biocompatible material may include a natural polymer, which may 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.

[0050] In some embodiments, tissue repair implant 8 may further comprise cytokines, growth factors, therapeutic compounds, drugs, cell populations, or any combination thereof.

[0051] In some embodiments, the insert body comprises coral or a coral derivative consisting essentially of aragonite, calcite, hydroxyapatite, or a combination thereof.

[0052] In some embodiments, tissue repair implant 8 may be contacted with a protein-containing, saline-containing, or carbohydrate-containing solution, or may be contacted with a biological fluid or a blood analog or a synthetic blood analog.

[0053] Those skilled in the art should understand that the above embodiments are exemplary and non-restrictive. Different technical features appearing in different embodiments can be combined to achieve beneficial effects. Those skilled in the art should be able to understand and implement other variations of the disclosed embodiments based on studying the drawings, the specification and the claims. Any reference numerals in the claims should not be construed as limiting the scope of protection. The presence of certain technical features 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 central 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 insert body (3) is a cylinder.

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

9. The tissue repair implant according to any one of claims 1 to 4, 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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