Degradable bone and ligament composite repair guide device

Abstract

The invention discloses a degradable bone and ligament composite repair guide device, which is implanted in a bone defect part or a ligament repair area needing mechanical support and tissue regeneration guide of a human body, and comprises a bone end, a transition area and a ligament end, wherein the bone end is implanted into the end part of a long bone of a human body or the surface of an irregular bone and covers a metaphyseal cancellous bone area around a ligament attachment point, and the bone end is made of a porous titanium alloy material; the ligament end covers the ligament fracture part, and the ligament end is a collagen nanofiber membrane; the transition area is located between the bone end and the ligament end and covers the junction area of the bone and the ligament and the joint capsule attachment point. The three-section type structural design of the bone end, the transition area and the ligament end is adopted, bone tissue, a bone and ligament junction area and ligament tissue are repaired and guided, and integrated synergistic repair of the bone and the ligament is achieved.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of bone and ligament composite repair, in particular to a degradable bone and ligament composite repair guide device. BACKGROUND

[0002] High-energy impact often leads to severe bone and ligament injuries, such as complex pelvic fractures, knee cruciate ligament ruptures, etc. The increasing popularity of sports fitness, although it improves people's physical quality, also increases the risk of sports injuries. For example, in competitive sports such as basketball and football, ankle sprains, rotator cuff injuries, and other ligament injuries, as well as tibial fractures and other bone injuries are common. In addition, the elderly population has a prominent problem of body function decline and osteoporosis, and a minor fall can cause a fracture, especially a hip fracture, which seriously affects the quality of life of the elderly and even endangers their lives. According to statistics, the number of patients seeking medical treatment for bone and ligament injuries worldwide is huge every year, and is showing an upward trend year by year, which has brought a heavy burden to the medical system and highlighted the urgency of developing effective treatment methods.

[0003] Bone and ligament injuries not only bring physical pain to patients, but also have a profound impact on their daily life and mental health. For patients with fractures, the limited activity of the injured part can lead to a decline in self-care ability in daily life, such as being unable to walk, dress, and wash, which seriously affects the quality of life. Long-term bed rest can also cause a series of complications, such as pulmonary infection, deep vein thrombosis, pressure sores, etc., further aggravating the condition. After ligament injury, the stability of the joint is destroyed, and the patient will have symptoms such as joint pain, swelling, and limited activity, affecting motor function. For example, after the rupture of the anterior cruciate ligament of the knee joint, the patient often cannot perform normal sports such as running and jumping, and even daily walking can be difficult, and long-term non-treatment can also lead to serious consequences such as joint cartilage wear and osteoarthritis. In addition, bone and ligament injuries can also cause psychological pressure to patients, such as anxiety, depression, and other emotional problems, affecting their social and work.

[0005] Current materials for bone and ligament repair mainly include metal materials, ceramic materials, and polymer materials, etc. Metal materials such as titanium alloy have good mechanical properties and can provide sufficient mechanical support, but their biological activity is poor, and the combination with the surrounding bone tissue mainly relies on mechanical embedding, making it difficult to achieve true bone integration, and long-term implantation may cause problems such as loosening and wear. Ceramic materials such as hydroxyapatite have good biocompatibility and bone conductivity, but they are brittle and have low mechanical strength, making it difficult to withstand large mechanical loads, limiting their application in load-bearing parts. High molecular materials such as polylactic acid and polycaprolactone have good biocompatibility and degradability, but their mechanical properties are relatively weak, and the degradation rate is difficult to accurately match the tissue regeneration rate, which may cause problems such as insufficient support or accumulation of degradation products during the repair process.

[0006] It is also worth noting that bone and ligament are closely related in anatomy and function, and they jointly maintain the stability and movement function of the joint. However, the existing repair materials and devices mostly focus on the repair of a single tissue, and lack comprehensive consideration of the coordinated repair of bone and ligament. For example, when repairing the ligament injury around the joint, only the repair of the ligament is concerned and the repair and reconstruction of the bone tissue at the ligament attachment point are ignored, which is easy to cause poor healing of the ligament-bone interface and affect the stability and functional recovery of the joint. Moreover, the existing bone and ligament repair materials and devices mostly lack sufficient biological activity, and are difficult to actively induce tissue regeneration and repair. Although some materials have good biocompatibility and can provide a surface for cells to adhere and grow, they cannot actively regulate the biological behavior of cells and promote the specific differentiation of tissues.

[0007] Therefore, it has important research value to develop a composite repair device capable of simultaneously promoting bone and ligament regeneration and realizing the coordinated repair of bone and ligament. SUMMARY

[0008] The purpose of the present application is to provide a degradable bone and ligament composite repair guide device, which adopts a three-section structure design of bone end, transition zone and ligament end, and repairs and guides the bone tissue, the junction area of bone and ligament and the ligament tissue respectively, realizes the integrated and coordinated repair of bone and ligament, and effectively solves the limitations of the existing repair materials and devices for single tissue repair.

[0009] To achieve the above purpose, the present application provides the following technical scheme: a degradable bone and ligament composite repair guide device, which is implanted in the bone defect site or ligament repair area of the human body that needs mechanical support and tissue regeneration guidance, and comprises a bone end, a transition zone and a ligament end, wherein: the bone end is implanted in the end of the long bone or the irregular bone surface and covers the metaphyseal cancellous bone area around the ligament attachment point, and the bone end is made of porous titanium alloy material; the ligament end covers the ligament fracture part, and the ligament end is a collagen nanofiber membrane; the transition zone is located between the bone end and the ligament end, and covers the junction area of bone and ligament and the capsule attachment point.

[0010] Preferably, the porosity of the bone end is 60%-80%, and the pore size is 100-500 μm. The porous structure provides a three-dimensional space for the migration and proliferation of bone cells (osteoblasts and osteoclasts). After implantation, the bone cells can move freely in the pores and carry out metabolic activities, and the bone-like substance is gradually deposited in the pores. Within a short period of time, 50% of the bone is grown into the bone-implant interface, the bonding strength between the bone end and the surrounding bone tissue is enhanced, and the stability and long-term effect of the repair are improved.

[0011] Preferably, the bone end is 3D printed by electron beam melting or selective laser melting, and the surface of the bone end is covered with a hydroxyapatite coating (1-5 μm thick). Hydroxyapatite is the main inorganic component of human bone, and has good biocompatibility and bone conduction. The coating activates the ALK1 signaling pathway of osteoblasts by releasing calcium and phosphate ions, promotes bone formation, further accelerates the bone integration process of the bone end, and makes the implant more quickly integrated with the surrounding bone tissue to play a normal mechanical and biological function.

[0012] Preferably, the surface of the bone end is plasma etched to form a plurality of uniformly distributed micro-nano groove structures (width 50-200 nm, depth 100-300 nm). Such micro-nano structures can significantly increase the roughness and specific surface area of the bone end surface, providing more adhesion sites for bone cell adhesion.

[0013] Preferably, a dynamic ligament guide module is integrated on the ligament end, and the dynamic ligament guide module is a spiral spring structure printed from silk fibroin fibers. Silk fibroin has good flexibility and biodegradability, and the spiral spring structure printed therefrom can provide dynamic mechanical stimulation during ligament repair. Such dynamic stimulation helps to regulate the biological behavior of ligament cells, promotes the ordered regeneration of ligament tissue, and improves the mechanical properties and functional recovery level of the repaired ligament.

[0014] Preferably, the ligament end and the bone end are arranged in a cross arrangement, which can better simulate the attachment mode of natural ligament in the human body, provide mechanical conduction more in line with the physiological state, and be conducive to the repair and functional reconstruction of the ligament. In addition, the collagen nanofiber membrane can provide a suitable microenvironment for ligament cells, promote the adhesion, proliferation and differentiation of ligament cells, and guide the regeneration of ligament tissue.

[0015] Preferably, when the ligament end is integrated with the dynamic ligament guide module, polylactic acid-glycolic acid (PLGA) is used as the connecting and fixing material. PLGA has good flexibility and biodegradability, and its degradation rate can be accurately controlled by adjusting the molar ratio of lactic acid to glycolic acid. In the early stage of ligament repair, PLGA can provide sufficient strength to firmly fix the dynamic ligament guide module on the collagen nanofiber membrane, ensuring that the module does not shift or fall off in the complex mechanical environment in the body. As the ligament tissue gradually regenerates and repairs, PLGA begins to degrade slowly, and its degradation products lactic acid and glycolic acid are normal metabolic intermediates in the human body and do not cause toxicity and inflammatory reactions to the surrounding tissue.

[0016] Preferably, the transition zone is made of polycaprolactone composite material. Polycaprolactone is a polymer material with good biocompatibility and biodegradability. Its composite materials can achieve suitable mechanical properties and degradation rates by adjusting the formulation and preparation process. During bone and ligament repair, the transition zone can gradually degrade while providing temporary support for the growth of new tissue, guiding the orderly regeneration of bone and ligament tissue at the junction, and realizing the natural transition and fusion of bone and ligament.

[0017] Compared with the prior art, the beneficial effects of the present invention are: This invention employs a three-segment structural design—the bone end, the transition zone, and the ligament end—to repair and guide the bone tissue, the bone-ligament junction, and the ligament tissue, respectively. This achieves integrated and synergistic repair of bone and ligaments, effectively overcoming the limitations of existing repair materials and devices in repairing single tissues. It significantly improves the stability of bone and ligament injury repair, the level of mechanical property recovery, and long-term treatment efficacy. Specific technical effects include: 1. The bone ends are made of porous titanium alloy, whose suitable porosity and pore size provide an ideal three-dimensional space for osteoblast migration and proliferation. The specially treated micro-nano groove structure and hydroxyapatite coating greatly increase the attachment sites for osteoblast adhesion, effectively activate osteoblast signaling pathways, and accelerate the osteointegration process.

[0018] 2. The polycaprolactone composite material used in the transition zone has good biocompatibility and biodegradability, and can gradually degrade over time, providing just the right temporary support for the growth of new tissue. The unique composition and structure of this material can guide the orderly regeneration of bone and ligament tissue in the junction area, promoting the natural fusion of the bone-ligament interface.

[0019] 3. The collagen nanofiber membrane at the ligament ends creates a suitable microenvironment for ligament cells, promoting cell adhesion, proliferation, and differentiation. The integrated dynamic ligament guiding module, a helical spring structure printed from silk fibroin fibers, provides dynamic mechanical stimulation during ligament repair. This mechanical stimulation precisely regulates the biological behavior of ligament cells, inducing them to synthesize and secrete more collagen, and promoting the orderly arrangement of ligament fibers. Attached Figure Description

[0020] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0021] Figure 1 This is a schematic diagram of the overall structural distribution of the present invention; Figure 2 This is a schematic diagram illustrating the application of the present invention to various joints of the human body; In the diagram: 1. Bone end; 2. Transition zone; 3. Ligament end. Detailed Implementation

[0022] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. 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 are within the scope of protection of the present invention.

[0023] In the description of this invention, it should be noted that the terms "vertical," "upper," "lower," "horizontal," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0024] In the description of this invention, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0025] Please see Figure 1 The present invention provides a technical solution: a biodegradable bone and ligament composite repair guiding device, wherein the composite repair guiding device is implanted in the human body at bone defect sites or ligament repair areas that require mechanical support and tissue regeneration guidance, and the composite repair guiding device includes a bone end 1, a transition area 2 and a ligament end 3.

[0026] In this embodiment, bone tip 1 is implanted into the end of a long bone or the surface of an irregular bone, covering the cancellous bone region of the metaphysis around the ligament attachment point. Bone tip 1 is made of porous titanium alloy material; the porosity of bone tip 1 is 60%-80%, and the pore size is 100-500μm. The porous structure provides three-dimensional space for the migration and proliferation of osteoblasts (osteoblasts and osteoclasts). After implantation, osteoblasts can move freely and carry out metabolic activities within the pores, and osteoid gradually deposits within the pores. In a short period of time, 50% bone ingrowth is achieved at the bone-implant interface, which enhances the bonding strength between bone tip 1 and the surrounding bone tissue, and improves the stability and long-term effect of the repair.

[0027] In this embodiment, the bone tip 1 is fabricated by electron beam melting or selective laser melting 3D printing, and its surface is covered with a hydroxyapatite coating (1-5 μm thick). Hydroxyapatite is the main inorganic component of human bone and has good biocompatibility and osteoconductivity. This coating releases calcium and phosphate ions to activate the ALK1 signaling pathway in osteoblasts, promoting bone formation and further accelerating the osseointegration process of the bone tip 1, allowing the implant to integrate with the surrounding bone tissue more quickly and perform normal mechanical and biological functions. The surface of the bone tip 1 is plasma-etched to form several evenly distributed micro-nano groove structures (50-200 nm wide, 100-300 nm deep). This micro-nano structure can significantly increase the surface roughness and specific surface area of ​​the bone tip 1, providing more attachment sites for osteoblast adhesion.

[0028] In this embodiment, the ligament end 3 covers the ligament rupture portion, and the ligament end 3 and the bone end 1 are arranged in a cross pattern. The cross arrangement can better simulate the attachment mode of the human body's natural ligaments, provide mechanical transmission that is more in line with physiological conditions, and is conducive to ligament repair and functional reconstruction.

[0029] In this embodiment, the ligament end 3 is a collagen nanofiber membrane. This membrane provides a suitable microenvironment for ligament cells, promoting their adhesion, proliferation, and differentiation, and guiding ligament tissue regeneration. A dynamic ligament guidance module is integrated onto the ligament end 3. This module is a helical spring structure printed from silk fibroin fibers. Silk fibroin possesses excellent flexibility and biodegradability, and the printed helical spring structure provides dynamic mechanical stimulation during ligament repair. This dynamic stimulation helps regulate the biological behavior of ligament cells, promotes orderly regeneration of ligament tissue, and improves the mechanical properties and functional recovery level of the repaired ligament. When integrating the ligament end 3 with the dynamic ligament guidance module, polylactic acid-glycolic acid copolymer (PLGA) is used as the connecting and fixing material. PLGA has excellent flexibility and biodegradability, and its degradation rate can be precisely controlled by adjusting the molar ratio of lactic acid to glycolic acid. In the early stages of ligament repair, PLGA provides sufficient strength to firmly fix the dynamic ligament guiding module onto the collagen nanofiber membrane, ensuring that the module does not shift or detach in the complex mechanical environment within the body. As the ligament tissue gradually regenerates and repairs, PLGA begins to slowly degrade. Its degradation products, lactic acid and glycolic acid, are intermediate products of normal metabolism in the human body and do not produce toxicity or inflammatory reactions in surrounding tissues.

[0030] In this embodiment, the transition zone 2 is located between the bone end 1 and the ligament end 3, covering the junction of bone and ligament as well as the joint capsule attachment point. The transition zone 2 is made of polycaprolactone composite material. Polycaprolactone is a polymer with good biocompatibility and biodegradability; its composite materials can achieve suitable mechanical properties and degradation rates by adjusting the formulation and preparation process. During bone and ligament repair, the transition zone 2 can gradually degrade, while simultaneously providing temporary support for the growth of new tissue, guiding the orderly regeneration of bone and ligament tissue at the junction, and achieving a natural transition and fusion of bone and ligament.

[0031] Please see Figure 2 In conjunction with the above embodiments, the present invention also provides a highly efficient application scheme for a bone and ligament composite repair device based on a three-segment structure design of bone end 1, transition zone 2 and ligament end 3 in multiple fields. The specific application scenarios and effects are as follows: Orthopedic Trauma Repair: This invention can play a significant role in complex cases of limb fractures complicated by ligament injuries. For example, tibial plateau fractures are often accompanied by anterior cruciate ligament (ACL) injuries, and traditional repair methods may struggle to simultaneously achieve adequate repair of both bone and ligament tissues. This invention, however, precisely repairs the fracture site through the bone end 1, utilizing its porous structure and bioactive coating to promote bone cell growth and osseointegration, rapidly restoring bone stability and support function. The transition zone 2 smoothly connects bone and ligament, reducing stress concentration and lowering the risk of refracture after repair. The ligament end 3 guides the orderly regeneration of ligament cells, enhancing ligament toughness and tensile strength. This helps patients recover limb function more quickly, reduces complications, and shortens the rehabilitation period.

[0032] Treatment of Joint Diseases: For some joint diseases, such as knee osteoarthritis with ligament laxity, this invention can serve as an effective treatment. In joint replacement or ligament reconstruction surgery, the three-segment structure of this invention is implanted into the joint. The bone end 1 integrates well with the surrounding bone tissue, providing stable support for the joint; the transition zone 2 helps improve the intra-articular biomechanical environment and reduce wear and tear on the articular cartilage; and the ligament end 3 enhances ligament stability and restores normal joint function. Compared with traditional treatment methods, this invention can better improve patients' joint function and quality of life, and increase the success rate and long-term efficacy of surgery.

[0033] Spinal Disease Repair: This invention also has significant application value in the treatment of spinal fractures combined with ligament injuries. The spine is the central skeleton of the human body, and its stability is crucial for maintaining normal posture and motor function. The bone end 1 structure of this invention can repair damaged vertebrae and provide sufficient mechanical support; the transition zone 2 can promote the healing of the vertebrae and surrounding ligaments, enhancing spinal stability; and the ligament end 3 helps restore the normal tension and elasticity of spinal ligaments, preventing spinal deformities and chronic pain. This is of great significance for improving patients' spinal function and enhancing their quality of life.

[0034] Sports Injury Repair: Athletes are prone to bone and ligament injuries during training and competition, such as ankle sprains with fractures and knee ligament tears. The three-segment structure of this invention meets athletes' needs for rapid rehabilitation and recovery from high-intensity exercise. In the early stages of injury, the bone end 1 quickly stabilizes the fracture site, reducing pain and swelling; the transition zone 2 and ligament end 3 guide orderly tissue repair, promoting the regeneration of ligaments and the bone-ligament junction. After systematic rehabilitation training, athletes can recover to their pre-injury athletic level more quickly, reducing career interruptions due to injury.

[0035] All standard parts used in this invention can be purchased commercially, and irregularly shaped parts can be customized according to the description and drawings. The specific connection methods for each part all employ conventional methods such as bolts, rivets, and welding, which are mature technologies in the prior art. The machinery, parts, and equipment all use conventional models in the prior art, and the circuit connections also use conventional connection methods in the prior art, which will not be detailed here. Any content not described in detail in this specification belongs to the prior art known to those skilled in the art.

[0036] In the description of this invention, 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 as "first" or "second" may explicitly or implicitly include one or more of that feature. "A plurality of" means two or more, unless otherwise explicitly specified.

[0037] The embodiments of the present invention are given for the purposes of illustration and description. Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Any changes, modifications, substitutions and variations made by those skilled in the art to the above embodiments within the scope of the present invention should be included within the protection scope of the present invention.

Claims

1. A biodegradable bone and ligament composite repair guiding device, wherein the composite repair guiding device is implanted in the human body at a bone defect site or ligament repair area requiring mechanical support and tissue regeneration guidance, the composite repair guiding device comprising a bone end (1), a transition zone (2), and a ligament end (3), characterized in that: The bone end (1) is implanted into the end of a long bone or an irregular bone surface and covers the metaphysis cancellous bone region around the ligament attachment point. The bone end (1) is made of porous titanium alloy material. The ligament end (3) covers the ligament fracture, and the ligament end (3) is a collagen nanofiber membrane; The transition zone (2) is located between the bone end (1) and the ligament end (3). The transition zone (2) covers the junction of bone and ligament and the attachment point of joint capsule.

2. The biodegradable bone and ligament composite repair guiding device according to claim 1, characterized in that: The porosity of the bone end (1) is 60%-80%, and the pore size is 100-500μm.

3. The biodegradable bone and ligament composite repair guiding device according to claim 1, characterized in that: The bone end (1) is formed by electron beam melting or selective laser melting 3D printing, and the surface of the bone end (1) is covered with a hydroxyapatite coating.

4. The biodegradable bone and ligament composite repair guiding device according to claim 1, characterized in that: The surface of the bone end (1) is etched by plasma to form several uniformly distributed micro-nano groove structures.

5. The biodegradable bone and ligament composite repair guiding device according to claim 1, characterized in that: The ligament end (3) is integrated with a dynamic ligament guiding module, which is a spiral spring structure formed by printing silk fibroin fibers.

6. The biodegradable bone and ligament composite repair guiding device according to claim 1, characterized in that: The ligament end (3) and the bone end (1) are arranged in a cross pattern.

7. The biodegradable bone and ligament composite repair guiding device according to claim 5, characterized in that: When the ligament end (3) is integrated with the dynamic ligament guiding module, polylactic acid-hydroxyacetic acid copolymer is used as the connection and fixation material.

8. The biodegradable bone and ligament composite repair guiding device according to claim 1, characterized in that: The transition zone (2) is made of polycaprolactone composite material.

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