A bio-augmentation system for rotator cuff injury

Abstract

The utility model relates to a kind of biological enhancement system for rotator cuff injury, including fixed line band and suture, fixed line band cooperation outer row anchor nail makes it fixed in the native Cable anatomic part of humerus fore-and-aft fulcrum, suture passes through fixed line band, for suture rotator cuff tissue, fixed line band according to the different types and degree of rotator cuff injury, including cable type, patch type, capsule bag type and gasket type, various types and different degree of rotator cuff injury can be solved, suture is the suture with different color, in the process of operation, it is convenient for medical staff to identify and operate, simplify surgical procedure, improve operation reliability.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, specifically to a bio-enhancing system for rotator cuff injuries. Background Technology

[0002] Rotator cuff tears are a common orthopedic condition. Arthroscopic surgery is currently the primary treatment for rotator cuff tears, including various techniques such as single-row and double-row anchor repair, bio-reinforced mesh repair, peripheral tendon transfer, superior articular capsule reconstruction, and mesh bridging / balloon implantation. However, the failure rate of current arthroscopic rotator cuff repair surgeries remains high, ranging from 13% to 94%. Reasons for this high failure rate include surgical experience, patient osteoporosis, excessive tension on the reconstructed tendon, neglect of the rotator cuff's cable structure, and underlying pathological changes such as tendon degeneration. These factors can all lead to recurrence and re-tear. Currently, rotator cuff repair surgery in clinical practice still faces challenges due to its high failure rate, long operation time, and significant trauma. Utility Model Content

[0003] To address the shortcomings of existing rotator cuff repair techniques, this invention provides a biological reinforcement system for rotator cuff injuries based on the cable concept of clinical anatomy, aiming to systematically address various types and degrees of rotator cuff injuries.

[0004] This invention provides a bio-enhancing system for rotator cuff injuries, comprising: The fixation suture is used in conjunction with external anchors to fix the fixation suture to the anterior and posterior fulcrums of the original cable anatomical part of the humerus; The suture thread, which passes through the fixing band, is used to suture the rotator cuff tissue, and the suture thread is a suture thread with different colors.

[0005] Optionally, the fixing strap is cable type, with 1-2 #2 or #5 stitches at each end. The cable type fixing strap is 20-100mm long, 2-8mm wide, and 0.5-3mm thick.

[0006] Optionally, the fixing cable is a patch type, which includes an edge region and a middle region surrounded by the edge region. The edge region is a tightly woven structure with a width of 3-5 mm and a thickness of 0.5-3 mm, and the middle region is a mesh structure with a mesh size of 0.1-0.5 mm.

[0007] Furthermore, the bio-enhancing system also includes a mesh patch, which is square, elliptical, or semi-circular. The mesh patch is sewn over the mesh structure, and the shape of the mesh structure matches the shape of the mesh patch. The mesh patch is 10-30 mm in size.

[0008] Optionally, the fixing strap is a pouch type, which includes a mesh pouch structure and an edge structure surrounding the side and one end of the mesh pouch structure. The other end of the mesh pouch structure has a pouch opening. The edge structure is constructed as a tightly woven structure with an edge width of 3-5 mm and a thickness of 0.5-3 mm. The outer end of the mesh pouch structure is also provided with a suture mesh for passing through the sealing suture. The suture mesh is located on the side near the pouch opening. The size of the suture mesh is 0.1-0.5 mm, and the size of the mesh pouch structure is 30-45 mm.

[0009] Optionally, the fixing strap is a pad type, with one side having a tightly woven structure and the other side having a mesh structure.

[0010] Furthermore, the bio-enhancing system also includes a collagen pad, which is square, round, or semi-circular, and is bonded to the mesh structure, the shape of which matches the shape of the collagen pad.

[0011] Furthermore, a No. 2 suture is provided along the circumferential direction at target intervals of 5-10mm, passing through the fixed suture.

[0012] Furthermore, the materials of the bio-enhanced system are hydrophilic and biocompatible.

[0013] Preferably, the material of the bio-enhancing system is composite collagen, PLLA, PLDA, polycarbonate, or polyurethane.

[0014] The beneficial effects that the embodiments of this specification may bring include, but are not limited to: (1) The bio-enhancing system of this utility model is based on the concept of cable in clinical anatomy. The fixation straps include cable type, patch type, pouch type and pad type, which can solve various types and degrees of rotator cuff injuries; (2) The bio-enhancing system with cable type fixation straps can enhance the holding force between the suture and the tendon, so that the suture tendon is fixed as a whole, reducing the cutting effect of the suture on the tendon and reducing the failure rate; (3) The 1-2 #2-5 sutures at both ends of the cable type fixation straps, together with the #2 sutures set circumferentially by the fixation straps, can further optimize the fixation effect of the suture tendon. When subjected to external force, the stress can be more evenly distributed on the tendon, avoiding tendon damage caused by local stress concentration, which helps to improve the strength of the repaired tendon and reduce the risk of re-tear; (4) The bio-enhancing system with patch type fixation straps, through the mutual cooperation of the intermediate mesh structure and the mesh patch, on the one hand, provides support for the rotator cuff tissue. Growth provides a good three-dimensional space, promotes cell adhesion and proliferation, and accelerates tissue repair; on the other hand, the mesh structure can also play a filtering and supporting role, prevent the excessive ingrowth of surrounding tissues, maintain the normal physiological interval between the subacromial space and the joint cavity, and reduce the occurrence of postoperative tissue adhesion; (5) The fixed suture is a bag-type biological enhancement system. The mesh bag structure is filled with biological filling material. The filled mesh bag structure can not only serve as a spacer between the acromion and the humeral head, press down on the humeral head to restore the force couple balance function, but also provide a stable space for the filling material. The biological filling material can slowly release nutrients and bioactive factors in the bag to promote the regeneration and repair of surrounding tissues; (6) The collagen pad contained in the biological enhancement system, in addition to serving as a spacer between the acromion and the humeral head, press down on the humeral head to restore the force couple balance function, collagen itself has good biological activity. It can promote the migration, proliferation and differentiation of rotator cuff tissue cells and accelerate the repair and regeneration of rotator cuff tissue. Moreover, the collagen pad can provide a moist microenvironment for the surrounding tissue, which is conducive to cell metabolism and nutrient exchange, further enhancing the effect of tissue repair; (7) The sutures are sutures with different colors, which are easy for medical staff to identify and operate during the operation, simplifying the operation process and improving the reliability of the operation. Attached Figure Description

[0015] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the accompanying drawings used in the description of the embodiments or the prior art will be briefly introduced below.

[0016] Figure 1 This is a schematic diagram of a bio-enhancing system with a fixed cable strip structure according to an embodiment of the present invention; Figure 2 This is a schematic diagram of a bio-enhancing system with a cable-type fixed strap for rotator cuff repair according to an embodiment of the present invention; Figure 3 This is a schematic diagram of a bio-enhancing system with a patch-type structure for fixing the wire strip, according to an embodiment of this utility model. Figure 4 This is a schematic diagram of a bio-reinforcement system with a patch-type fixed cable tie used for rotator cuff repair according to an embodiment of the present invention; Figure 5 This is a schematic diagram of a bio-enhancing system with a bag-shaped structure for fixing the wire strip, according to an embodiment of this utility model. Figure 6 This is another schematic diagram of the bio-enhancing system with a bag-shaped structure for fixing the wire strip, according to an embodiment of this utility model; Figure 7 This is a schematic diagram of the structure of the bio-enhancing system with a pad-type fixed wire strip according to an embodiment of the present invention; In the diagram: 1-suture, 2-fixation suture, 3-mesh patch, 4-mesh pouch structure, 41-pouch opening, 42-sealing suture, 5-collagen pad. Detailed Implementation

[0017] To enable those skilled in the art to better understand the present invention, the technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort should fall within the protection scope of the present invention.

[0018] The term "an embodiment" or "embodiment" as used herein refers to a specific feature, structure, or characteristic that may be included in at least one implementation of the present invention. In the description of the present invention, it should be understood that the terms "upper," "inner," "lower," etc., indicating orientation or positional relationships based on the orientation or positional relationships shown in the accompanying drawings, are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the referred device or element must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present invention. Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined with "first" and "second" may explicitly or implicitly include one or more of that feature. Moreover, the terms "first," "second," etc., are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that embodiments of the present invention described herein can be implemented in orders other than those illustrated or described herein.

[0019] To address the problems existing in the prior art, this application provides a bio-enhancing system for rotator cuff injuries, specifically, as follows: Figures 1-7 As shown, the bio-enhancing system includes a fixation band 1 and a suture 2. The fixation band 1, together with external anchors, is fixed to the anterior and posterior fulcrums of the original cable anatomical part of the humerus. The suture 2 passes through the fixation band 1 and is used to suture the rotator cuff tissue. The suture 2 is a suture with different colors, which makes it easy for medical staff to identify and operate during the operation, simplifying the surgical procedure and improving the reliability of the operation.

[0020] Furthermore, the fixation strap 1 is available in various types and degrees depending on the type and severity of rotator cuff injury, including cable type, patch type, pouch type, and pad type. It is understandable that current traditional surgical treatments for rotator cuff injuries do not pay attention to the basic pathological changes such as the cable structure of the rotator cuff and tendon degeneration, which can easily lead to recurrence and re-tear. Based on the concept of cable in clinical anatomy, this utility model sets the fixation strap 1 in multiple types to solve various types and degrees of rotator cuff injuries.

[0021] In one feasible solution, refer to Figure 1 As shown, the fixation strap 1 has a cable-like structure, with 1-2 #2 or #5 sutures at each end. The cable-like fixation strap is 20-100mm long, 2-8mm wide, and 0.5-3mm thick. This cable-like structure and bio-reinforcement system enhances the holding force between the sutures and the tendon, providing integrated fixation and reducing the cutting effect of the sutures on the tendon, thus lowering the failure rate. The 1-2 #2 or #2 sutures at each end of the cable-like fixation strap, combined with the #2 sutures spaced circumferentially around the fixation strap, further optimize the fixation effect on the tendon. When subjected to external force, the stress is more evenly distributed on the tendon, preventing tendon damage due to localized stress concentration. This helps improve the strength of the repaired tendon and reduces the risk of re-tear.

[0022] In another feasible solution, refer to Figure 3 As shown, the fixing tape 1 is a patch-type structure, which includes an edge area and a middle area surrounded by the edge area. The edge area is a tightly woven structure with a width of 3-5mm and a thickness of 0.5-3mm. The tightly woven structure helps to enhance the overall stability of the mesh patch 3 and can also provide a more secure attachment point for the suture 2. The middle area of ​​the patch-type fixing tape is a mesh structure with a mesh size of 0.1-0.5mm.

[0023] For the preferred option, continue to refer to... Figure 3The bio-enhancing system also includes a mesh patch 3, which is square, oval, or semi-circular. The mesh patch 3 is sutured over the mesh structure, and the shape of the mesh structure matches the shape of the mesh patch. The size of the mesh patch is 10-30 mm.

[0024] Understandably, the mesh structure in the middle region works in conjunction with the mesh patch 3. On the one hand, it provides a good three-dimensional space for the growth of rotator cuff tissue, promotes cell adhesion and proliferation, and accelerates tissue repair. On the other hand, the mesh structure can also play a filtering and supporting role, preventing excessive ingrowth of surrounding tissues, maintaining the normal physiological interval between the subacromial space and the joint cavity, and reducing the occurrence of postoperative tissue adhesions.

[0025] In another feasible solution, refer to Figure 5 As shown, the fixation strap 1 is a pouch-type structure, comprising a mesh pouch structure 4 and an edge structure surrounding the sides and one end of the mesh pouch structure 4. The mesh pouch structure is used to fill with a bio-based filler material. After being filled with the bio-based filler material, the mesh pouch structure 4 not only acts as a spacer between the acromion and the humeral head, pressing down on the humeral head to restore torque balance, but also provides a stable space for the filler material. The bio-based filler material can slowly release nutrients and bioactive factors within the pouch, promoting the regeneration and repair of surrounding tissues. The other end of the mesh pouch structure 4 has a pouch opening 41. The edge structure is constructed as a tightly woven structure with an edge width of 3-5 mm and a thickness of 0.5-3 mm. A suture mesh is also provided on the outer end of the mesh pouch structure 4. The suture mesh is used to pass through the sealing suture 42. The suture mesh is located on the side near the pouch opening 41, and the suture mesh size is 0.1-0.5 mm. The suture hole mesh design facilitates precise control of the position and tension of the sealing suture 42, ensuring a tight seal of the pouch opening 41, preventing leakage of filling material, and improving the accuracy and safety of the surgical procedure.

[0026] In another feasible solution, refer to Figure 7 As shown, the fixing tape 1 has a pad-type structure. One side of the pad-type fixing tape has a tightly woven structure, and the other side has a mesh structure.

[0027] Furthermore, the bio-enhancing system also includes a collagen pad 5, which is square, round, or semi-circular. The collagen pad 5 is adhered to and covers a mesh structure, the shape of which matches the shape of the collagen pad.

[0028] The collagen pads included in the bio-enhancing system, besides acting as a spacer between the acromion and the humeral head to press down on the humeral head and restore torque balance, also possess excellent bioactivity. Collagen itself can promote the migration, proliferation, and differentiation of rotator cuff tissue cells, accelerating the repair and regeneration of the rotator cuff tissue. Furthermore, the collagen pads provide a moist microenvironment for the surrounding tissues, which is beneficial for cell metabolism and nutrient exchange, further enhancing the tissue repair effect.

[0029] Preferably, a No. 2 suture is provided every 5-10 mm around the fixing strap 1, which can pass through the fixing strap freely or be fixed, which helps to enhance the connection stability between the suture 1 and the main structure.

[0030] Furthermore, the materials in the bio-enhancing system are hydrophilic and biocompatible. The hydrophilic properties of the materials facilitate the interaction between the materials and surrounding tissues, regulate the adsorption pattern of proteins on the material surface, reduce the activation of inflammatory factors, and enable the surrounding tissues to repair in a relatively stable, low-inflammatory environment. This helps to alleviate postoperative pain and swelling symptoms and accelerate the recovery process. The biocompatibility properties can promote the fusion of tissues and implanted materials and enhance the repair effect.

[0031] Preferably, the materials used in the bio-enhancing system are composite collagen, PLLA, PLDA, polycarbonate, or polyurethane.

[0032] The following four examples illustrate the implementation methods of bio-enhancing systems with fixed cable strip structures of cable type, patch type, capsule type, and pad type, respectively: The fixed cable of the bio-enhancing system in Example 1 adopts a cable-type structure: (Refer to...) Figure 1 and Figure 2 As shown, during the surgery, for large, medium, and small rotator cuff tears, specialized implantation instruments are first used to accurately insert knotless external anchors into the anterior and posterior fulcrums of the original cable anatomical structure of the humerus, ensuring the anchors are firmly fixed within the bone tissue. Subsequently, the two ends of a cable-type fixation band are connected to the implanted knotless external anchors using instruments, ensuring the fixation band 1 is under appropriate tension. Next, suture 2 is passed through the rotator cuff tissue for suturing. Whether to tie a knot depends on the quality of the rotator cuff tissue. If the rotator cuff tissue is of good quality, no knot is needed, relying on the fixation effect of the knotless external anchors and fixation band 1 to maintain the position of the rotator cuff tissue. If the quality is poor, a knot is tied to prevent the suture from loosening or the rotator cuff tissue from shifting again. Finally, knotless external anchors are used to fix suture 2 to the greater tuberosity of the humerus, completing the entire suturing process.

[0033] The fixing strip of the bio-enhancing system in Example 2 adopts a patch-type structure: (Refer to...) Figure 3 and Figure 4As shown, during the surgery, for large rotator cuff tears, the two corners of the semi-circular bottom of the patch-type rotator cuff suture system are first fixed to the anterior and posterior axial points of the original cable anatomical structure of the humerus using knotless external anchors. Then, the semi-circular peripheral suture 2 is passed through the rotator cuff tissue and sutured and knotted (or left untied depending on the quality of the rotator cuff tissue). A suitable mesh patch 3 is selected and attached to the semi-circular mesh line, using the semi-circular mesh as structural support. The semi-circular peripheral suture 2 that has already been sutured to the rotator cuff tissue is then used to suture the mesh patch 3 again. By knotting the suture 2, the mesh patch 3 is reliably fixed to the semi-circular mesh, ensuring close contact with the rotator cuff tissue, enhancing the stability of the repair site, reducing suture tension, and promoting the healing of the rotator cuff tissue.

[0034] In Example 3, the fixation sutures of the bio-enhancing system employ a pouch-like structure. During surgery, when faced with a large, irreparable rotator cuff tear, knotless external anchors are used to fix the two corners of the pouch-like suture system at the anterior and posterior anatomical fulcrums of the original humeral cable. Then, the peripheral sutures 2 are passed through the rotator cuff tissue and sutured and knotted, achieving a bridge between the pouch-like suture system and the rotator cuff tissue. A bio-filling material is selected and filled into the mesh pouch 3. The pouch opening 41 is then sutured closed with sealing sutures 42. At this point, the mesh pouch 4 acts as a spacer between the acromion and the humeral head, pressing down on the humeral head to restore torque balance.

[0035] The fixation sutures of the bio-enhancing system in Example 4 employ a pad-type structure: During surgery, for large, irreparable rotator cuff tears, knotless external anchors are used to fix the two corners of the bottom fixation sutures 1, containing collagen pads, to the anterior and posterior anatomical fulcrums of the original humeral cable. Peripheral sutures 2 are then passed through the rotator cuff tissue for suturing and knotting, achieving a bridge between the bio-enhancing system and the rotator cuff tissue. Because the system includes collagen pads 5, after the above steps, the collagen pads 5 naturally reside between the acromion and the humeral head. The presence of the collagen pads not only acts as a spacer, pressing down on the humeral head to restore torque balance, but also utilizes its excellent biocompatibility and bioactivity to promote rotator cuff tissue regeneration. During postoperative recovery, the collagen pads gradually release growth factors and other bioactive substances, attracting surrounding cells to migrate to the rotator cuff injury site, accelerating tissue repair, improving repair effectiveness, and helping patients better recover shoulder function.

[0036] The above are merely preferred embodiments of the present utility model and are not intended to limit the present utility model. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present utility model shall be included within the protection scope of the present utility model.

[0037] The foregoing has shown and described the basic principles, main features, and advantages of this utility model. Those skilled in the art should understand that this utility model is not limited to the above embodiments. The embodiments and descriptions in the specification are merely illustrative of the principles of this utility model. Various changes and modifications can be made to this utility model without departing from its spirit and scope, and all such changes and modifications fall within the scope of the claimed utility model.

Claims

1. A bio-enhancing system for rotator cuff injuries, characterized in that, include: The fixation suture (1) is used in conjunction with the external anchor pins to fix the fixation suture (1) to the anterior and posterior fulcrum of the original cable anatomical part of the humerus; Suture (2), which passes through the fixing band (1) and is used to suture the rotator cuff tissue, wherein the suture (2) is a suture with different colors; Mesh patch (3), the mesh patch (3) is square, elliptical or semi-circular, the mesh patch (3) is sewn over the mesh structure, the shape of the mesh structure matches the shape of the mesh patch (3).

2. The bio-enhancing system for rotator cuff injuries according to claim 1, characterized in that, The fixing strap (1) is of cable type. Each end of the cable type fixing strap has 1-2 2-5# stitches. The length of the cable type fixing strap is 20-100mm, the width is 2-8mm, and the thickness is 0.5-3mm.

3. The bio-enhancing system for rotator cuff injuries according to claim 1, characterized in that, The fixing tape (1) is a patch type, which includes an edge area and a middle area surrounded by the edge area. The edge area is a tightly woven structure with a width of 3-5mm and a thickness of 0.5-3mm. The middle area is a mesh structure with a mesh size of 0.1-0.5mm.

4. The bio-enhancing system for rotator cuff injuries according to claim 1, characterized in that, The fixing strap (1) is a pouch type, which includes a mesh pouch structure (4) and an edge structure surrounding the side and one end of the mesh pouch structure (4). The other end of the mesh pouch structure (4) has a pouch opening (41). The edge structure is constructed as a tightly woven structure with an edge width of 3-5 mm and a thickness of 0.5-3 mm. The outer end of the mesh pouch structure (4) is also provided with a suture hole mesh. The suture hole mesh is used to pass through the sealing suture (42). The suture hole mesh is located on the side near the pouch opening (41). The size of the suture hole mesh is 0.1-0.5 mm.

5. A bio-enhancing system for rotator cuff injuries according to claim 1, characterized in that, The fixing strap is a pad type, with one side having a tightly woven structure and the other side having a mesh structure.

6. A bio-enhancing system for rotator cuff injuries according to claim 5, characterized in that, The bio-enhancing system also includes a collagen pad (5), which is square, round, or semi-circular. The collagen pad (5) is bonded to and covers the mesh structure, and the shape of the mesh structure matches the shape of the collagen pad (5).

7. A bio-enhancing system for rotator cuff injuries according to claim 1, characterized in that, The fixing strip (1) is provided with a No. 2 suture line passing through the fixing strip (1) at circumferential intervals of 5-10 mm.

8. A bio-enhancing system for rotator cuff injuries according to claim 1, characterized in that, The materials used in the bio-enhancing system are hydrophilic and biocompatible.

9. A bio-enhancing system for rotator cuff injuries according to claim 1, characterized in that, The materials used in the bio-enhancing system are composite collagen, PLLA, PLDA, polycarbonate, or polyurethane.

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