Scrap-containing bone implant capable of realizing negative pressure drainage

Abstract

A chip containing type bone implant capable of achieving negative pressure drainage comprises a support shell and a base, and an inner cavity of the support shell is filled with filler materials. The support shell and the base are detachably connected, and the internal filler can be placed in an internal cavity of the support shell through the tail end opening. A fluid suction assembly is arranged on the base; a positioning insertion piece is arranged at the head end of the base, and the positioning installation piece of the support shell and the positioning insertion piece at the head end of the base are in surface fit connection; a sealed annular space is formed at the head end position of the positioning installation piece and the positioning insertion piece, and abrasion particles generated when the positioning installation piece and the positioning insertion piece are used in cooperation are collected in the sealed annular space. The novel implant is applied, in the process of treating femoral head necrosis, the internal pressure of the femoral head can be reduced, an intraosseous circulation environment can be established, and non-degradable material particles can be prevented from invading the human body.

Description

Technical Field

[0001] The present invention relates to medical devices, and more specifically, to an implant for bone reconstruction, in particular to a chip-containing negative pressure drainage bone implant that continuously promotes the release of pressure or fluid or gas accumulation. It is mainly used to solve the problem of bone damage, necrosis or defect, and focuses on the technical solution to improve bone tissue reconstruction and microcirculation. Background Art

[0002] Femoral head necrosis, also known as avascular necrosis (ONFH), is a common and difficult-to-treat disease in the field of orthopedics. It originates from insufficient local blood supply to the femoral head due to multiple factors, leading to ischemia, necrosis, trabecular fracture and femoral head collapse of bone cells. Without effective treatment, about 80% of patients will experience femoral head collapse within 1-4 years, which will lead to joint dysfunction and eventually have to undergo artificial joint replacement surgery. The high cost of artificial joint replacement surgery brings huge economic burden to patients and society, and because artificial joints have a certain service life, young and middle-aged patients still face various complications, revisions, secondary replacements and other problems after joint replacement. In addition, the difficulty and risk of artificial joint reoperation are high, which further increases the economic burden on patients and significantly reduces their quality of life. The latest research shows that the incidence of femoral head necrosis has been increasing year by year in recent years, and the age of onset is showing a trend of younger age. Early treatment of femoral head necrosis to preserve the patient's own joint function has always attracted much attention.

[0003] At present, there is no unified principle or consensus for the treatment of early ONFH, and the treatment plan is usually determined by the doctor based on his knowledge, skills and experience. The clinical treatment methods for early ONFH can be divided into non-surgical treatment and surgical treatment. Non-surgical treatment can relieve symptoms, but there is insufficient evidence to show that such treatment can prevent femoral head collapse, protect joint function, postpone joint replacement or cure ONFH. Among the various hip-preserving surgical methods for early ONFH, core decompression combined with various bone repair biomaterials filling and / or structural bone support can effectively remove necrotic tissue, reduce intraosseous pressure, improve femoral circulation, promote neovascularization, enhance bone formation, reduce the risk of proximal femoral fractures, and improve the treatment effect of ONFH. Early removal of diseased tissue, use of implant materials to fill and support damaged areas and promote bone regeneration are the key directions of current research and clinical treatment.

[0004] The existing support implants are usually connected to the drill hole in the femoral head by threading. The drill hole is located in the femoral head. The implant is inserted along the insertion direction by applying force to the coronal end. These implants can only provide internal support functions and cannot promote the reconstruction of internal microcirculation or promote the rapid integration of bone tissue growth and implants. For example, conventional femoral head necrosis implants such as metal tantalum rods only have mechanical support and cannot prevent the development of femoral head necrosis pathological processes. Its bone integration ability is limited and cannot solve the problem of insufficient blood supply to the femoral head. It cannot continuously release intraosseous pressure or metabolic products during bone integration. It is difficult for metal tantalum rods to achieve ideal bone integration at the lesion site, which may lead to bone resorption at the bone integration interface, and then cause collapse again.

[0005] After the implant, fluid and gas will accumulate inside the femoral head, and the method of discharge needs to be comprehensively judged based on the amount of fluid, the cause of the disease, and the patient's physical condition. If the amount of fluid and gas is small, and the condition is in the early stages, conservative treatment can be used to promote the absorption and discharge of fluid and gas. If the amount of fluid and gas is large, and conservative treatment is ineffective, invasive operations may be required. For example, puncture and fluid extraction, the fluid and gas are directly extracted from the body. There is a risk of infection during puncture surgery, and the surrounding blood vessels, nerves and other tissues may be damaged during the puncture. In addition, this operation only applies treatment to the surrounding tissues outside the bone, and it cannot specifically drain the fluid and gas in the affected area of ​​the bone. If the bone is not effectively treated and controlled, the fluid and gas accumulation are likely to reappear, and the disease may even progress further.

[0006] Although implants are widely used in the treatment of femoral head necrosis, the problem of material wear is prominent. Existing implants are mostly made of metal materials, such as metal tantalum rods. Under the mechanical stress generated by human activities, the metal atoms are broken and the wear debris is formed. Implants with different material combinations are also prone to wear and debris at the contact interface of different materials due to differences in material physical properties. In addition, complex structural designs, such as stress concentration points such as corners and gaps, and micro-motion caused by unstable connection with bone tissue, also accelerate the formation of wear debris. Wear debris is serious and can cause inflammatory reactions. After the immune system recognizes wear debris, macrophages release inflammatory factors, causing local redness, swelling, pain, and fever. Long-term inflammation can also cause chronic tissue damage, affect the activity of osteoblasts in the femoral head, and destroy bone. Wear debris can also directly damage tissues, embed into soft tissues to affect their functions, interfere with bone repair and reconstruction, cause osteolysis, and increase the risk of fractures. Existing countermeasures have limitations. In terms of material improvement, although new alloys or ceramic materials have been tried, they are costly and difficult to process. For example, the brittleness of ceramics limits their application. When optimizing the structure, it is difficult to balance function and simplification, and the optimized design may affect the support or integration capabilities. In addition, the manufacturing process is complex, costly, and the effect is not ideal. In short, the problem of material wear generated by femoral head necrosis implants urgently needs innovative solutions.

[0007] During surgery, poor integration of implant effects is also an important issue. Due to the complexity of the implant structure, it may be difficult to fully integrate with the surrounding tissues, thus affecting the stability and functional recovery of the implant site. In addition, due to the inconvenience of surgical operation, the implant position may be inaccurate or accidental damage may occur during the implantation process, further affecting the integration of the implant effect and the achievement of the therapeutic effect.

[0008] Therefore, there is an urgent need for a bone implant that can provide mechanical support while removing necrotic tissue, promote bone integration and rebuild bone microcirculation, effectively solve the problem of implant debris, continuously reduce intraosseous pressure, and promote the discharge of effusion and gas. The production cost of this implant is controllable, it can be mass-produced, and has achieved good results in clinical applications. In summary, future research and development should focus on designing and manufacturing an ideal bone implant with a simplified structure, controllable production, easy operation, and the ability to effectively promote bone tissue repair. This will hopefully provide a more reliable and effective solution for the treatment of osteonecrosis and bone defects, and bring better treatment effects and quality of life to patients. Summary of the invention

[0009] The purpose of the present invention is to overcome the shortcomings of the prior art and provide a method for discharging fluid and gas after bone necrosis, continuously reducing intraosseous pressure without the need for intraosseous puncture, reducing infection risks, effectively solving the problem of implant wear, having long-term stability, good biocompatibility, and perfectly adapting bone implants to different populations. The production cost of the implant is controllable, modular mass production is possible, and good results are achieved in clinical applications.

[0010] A chip-containing negative pressure drainage bone implant comprises a support shell and a base, wherein the inner cavity of the support shell is filled with a filling material; the support shell and the base are detachably connected.

[0011] The bracket shell has a rear end opening, and the rear end opening is connected to the inner cavity of the bracket shell;

[0012] The internal filler can be placed into the internal cavity of the stent shell through the tail end opening;

[0013] A fluid suction component is disposed on the base;

[0014] The tail end opening is used as a positioning installation piece, the head end of the base is provided with a positioning insert, and the positioning installation piece of the bracket shell forms a surface matching connection with the positioning insert of the head end of the base;

[0015] The positioning installation piece and the positioning insert piece form a sealed annular space at the head end position, and the wear particles generated by the positioning installation piece and the positioning insert piece during the coordinated use are collected in the sealed annular space.

[0016] Furthermore, the bracket shell includes a porous part and a tail end connecting part. The porous part is a porous material with overall gaps connected, and the tail end connecting part is a solid material, and the two are formed into one body; the positioning mounting piece is formed on the tail end connecting part.

[0017] Further, the positioning insert is formed integrally with the base.

[0018] Furthermore, a sealing ring is formed at the head end of the connection part positioning installation piece, and the sealing ring is integrated with the connection part and is also made of solid material; a sealing cylinder is formed at the head end of the positioning insert, and the sealing cylinder passes through the sealing ring, and a gap seal is formed between the ring mouth side of the sealing ring and the surface of the sealing cylinder.

[0019] Furthermore, the depth of the positioning installation piece is greater than the length of the positioning insert piece. After the positioning installation piece and the positioning insert piece are positioned together, a sealed annular space is formed by the positioning installation piece, the sealing ring and the positioning insert piece.

[0020] Furthermore, a groove is formed on the side surface of the tail end of the sealing ring, so that the wear particles of the material are more likely to stay and accumulate.

[0021] Furthermore, the side surface of the upper tail end of the sealing ring adopts an inclined surface, that is, the thickness of the ring mouth of the sealing ring is greater than the thickness of the root, and a sink groove is formed at the base of the sealing ring;

[0022] The thickness of the sealing ring is relatively large, and the gap sealing surface with the sealing cylinder is relatively large, thereby improving the sealing effect.

[0023] Furthermore, the sealing ring has a plurality of strip-shaped reinforcing ribs extending toward the head end, and is connected to the porous portion through the reinforcing ribs.

[0024] Further, the fluid suction assembly includes an expansion channel, a drainage channel and a negative pressure channel;

[0025] The expansion channel is a through hole, the head end of which opens on the top surface of the sealing cylinder, and the expansion channel forms an opening at the tail end of the base;

[0026] A drainage channel is formed at the center of the base, and the drainage channel is located at the axis of the base;

[0027] The negative pressure channel opens at the rear end of the base, and its head end is connected to a radially arranged cylindrical negative pressure cavity;

[0028] The cylindrical negative pressure cavity is connected to the head end of the drainage channel.

[0029] Furthermore, the positioning mounting piece and the positioning insert are polygonal prisms, the prisms have a certain taper, and the tapers of the two are consistent.

[0030] Specifically, the advantages of the present invention are as follows:

[0031] First, continuous release of intra-bone pressure. The structural design of the implant enables it to form a relatively stable space with the surrounding bone tissue after being implanted in the human body. The porous part of the stent shell has a certain elasticity, and can produce slight deformation when the pressure inside the femoral head changes. This deformation can regulate the pressure inside the bone. At the same time, the fluid suction component on the base also assists in the release of pressure to a certain extent. When the pressure inside the femoral head increases, the pressure will cause the stent shell to deform, so that the pressure in the high-pressure area of ​​the bone is dispersed to the porous part and the surrounding space, and then the excess pressure is discharged through the action of the fluid suction component, thereby achieving the effect of continuous release of intra-bone pressure. Excessive intra-bone pressure is an important factor in the progression of femoral head-related diseases. Releasing intra-bone pressure through this implant can help alleviate patients' pain symptoms and improve their quality of life. For example, for patients with early femoral head necrosis, it can relieve hip joint pain caused by increased pressure inside the femoral head, reduce the degree of limitation of their daily activities, and restore some work and life capabilities.

[0032] Second, it promotes the discharge of effusion and gas. The porous part of the stent shell is not only conducive to pressure regulation, but its interstitial structure also provides a discharge channel for effusion and gas. There is a small gap between the porous part and the surrounding bone tissue, and the effusion and gas can enter the porous part through these gaps. The fluid suction component on the base plays the role of active drainage. The design of the expansion channel can collect the effusion and gas from the porous part, and its special thick and thin segment structure ensures that the effusion and gas are not easy to flow back after entering. Under the action of the external negative pressure drainage device, the drainage channel and the negative pressure channel form a pressure gradient from the inside to the outside of the stent, which promotes the effusion and gas to be discharged from the porous part through the fluid suction component along this pressure gradient. This is conducive to maintaining the stability of the internal microenvironment of the femoral head, promoting the formation and repair of new bones, and delaying the progression of diseases such as femoral head necrosis. Taking femoral head avascular necrosis as an example, the timely discharge of effusion and gas produced by necrotic tissue can provide space and nutritional support for new bone tissue, help improve the self-repair ability of the femoral head, and increase the chance of successful hip preservation treatment.

[0033] Third, through the design of the fluid suction component, it has the characteristics of one-way flow. The structure and layout of the expansion channel, drainage channel and negative pressure channel in the fluid suction component jointly realize one-way flow. The thinner section of the expansion channel provides reverse flow resistance to prevent external substances from entering in reverse. When no negative pressure is applied to the drainage channel, its thinner diameter and special connection structure prevent the accumulated fluid and gas from overflowing, and the accumulated fluid and gas can be smoothly drained out under the action of negative pressure. The negative pressure channel is connected to the external negative pressure drainage device to form a negative pressure space in the cylindrical negative pressure cavity to guide the directional flow of accumulated fluid and gas. When the external pressure tries to enter in reverse, the structure and pressure distribution of each channel can effectively prevent it from entering. While releasing pressure and effusion and gas accumulation, it can reduce the reverse invasion of harmful substances such as external bacteria and inflammatory factors, and reduce the risk of joint infection. For patients who need long-term treatment and management, this helps to maintain the health of the joints.

[0034] Fourth, reduce the number of medical visits and costs. Since the implant can continuously and stably release the intraosseous pressure, discharge the accumulated fluid and gas, and has good one-way flow characteristics to prevent infection and other problems, its function remains effective for a long time. Compared with traditional treatment methods such as repeated puncture and fluid extraction, drug injection, etc., these traditional methods need to be operated regularly, and each operation involves the cost of medical equipment, time and energy of medical staff. Once the implant is implanted, there is no need for frequent intervention for a long time, which reduces the number of times the patient goes to the hospital, thereby reducing the comprehensive costs such as transportation costs, medical operation costs, and loss of work income due to leave for medical treatment. For example, traditional puncture and fluid extraction may require patients to go to the hospital once a week or a month for operation, which costs a lot of time and money in the long run. After implanting the implant of the present invention, the patient may not need to perform such frequent operations for several months or even several years, saving a lot of medical costs, and also improving the patient's acceptance and compliance to treatment, because the patient does not need to frequently bear the physical discomfort and psychological pressure caused by invasive operations such as puncture, which is more conducive to the long-term maintenance of the treatment effect.

[0035] Fifth, from the perspective of surgical operation, the surgical implantation method of this implant is simple, less traumatic, less burdensome to the patient's body, and the postoperative recovery time is also shortened. The structural design of the bracket shell and the base facilitates surgical operation. The overall shape and size design of the bracket shell is suitable for insertion into the drilled hole of the femoral head, and its tail end opening is used as a positioning mounting piece, and the positioning insert of the base is simple and accurate. The positioning mounting piece and the positioning insert of the polygonal prism structure can achieve axial guidance during the insertion process, limit rotation, and ensure accurate installation position. At the same time, the taper structure makes it easy to control the insertion depth, and the surgeon can easily place the implant in the appropriate position during operation. In addition, the threaded or rough surface design on the outer surface of the base helps to better adhere to the bone during implantation, further improving the stability of the implant, and the concave hole or groove at the bottom of the base facilitates connection with external instruments for surgical operation, simplifying the surgical steps. It is particularly important for patients with poor physical condition and limited tolerance, such as elderly patients with femoral head lesions. Traditional complex surgery may cause a greater burden on their bodies and difficult postoperative recovery. The simple implantation method of this implant reduces the operation time and surgical trauma. Patients bleed less during the operation, suffer less stress response from the body, suffer less postoperative pain, can start the recovery process faster, shorten the hospital stay and overall recovery time, and enable more such patients to have the opportunity to receive effective treatment, thereby improving their quality of life and treatment outcomes.

[0036] Sixth, the implant has good biocompatibility and will not cause strong immune rejection or inflammatory reactions in the body, which can reduce the complications caused by immune reactions and the need for follow-up treatment, and the patient's treatment experience and rehabilitation effect will be better. For example, there will be no immune rejection phenomena such as local redness, swelling, fever, and effusion after implantation.

[0037] Seventh, from the perspective of long-term effects, it has lasting performance and durability, and can work in the body for a long time without frequent replacement or adjustment, which can save patients subsequent treatment costs and energy. For example, after implantation, it can work stably for several years or even more than ten years, and patients do not need to worry about the need for another surgical intervention in the short term.

[0038] Eighth, from the perspective of adaptability, this implant can be customized according to the anatomical structure and pathological conditions of the femoral head of different patients, accurately matching the needs of each patient, and the treatment effect will be more ideal. The structural design of the stent shell and the base allows for personalized adjustments during the production process. The size and shape of the stent shell can be customized according to the anatomical structure of the femoral head of different patients, such as the size and shape of the femoral head and the specific conditions of the lesion site. The size and surface features of the base (such as the specific design of the thread or rough surface) can also be adjusted accordingly to ensure that the implant can perfectly fit the individual patient's bones. In addition, the selection of filler materials and filling methods can also be personalized according to the patient's condition and needs, such as selecting appropriate filling materials such as autologous bone, allogeneic bone or artificial bone according to the degree of bone defect, and adjusting parameters such as filling density. For example, the most suitable implant solution can be provided for patients of different ages, genders, weights, and degrees and ranges of lesions.

[0039] Ninth, prevent foreign particles from invading the human body and improve the sealing effect. The chip groove (i.e., the sealed annular space formed by the positioning mounting parts, the sealing ring, and the positioning insert) can effectively collect material wear particles generated during the connection between the bracket shell and the base, especially PEEK material particles. Since PEEK material particles are not biodegradable, they may have adverse consequences if they enter the human tissue circulation. The chip groove can prevent these particles from invading the internal tissues of the human body and avoid potential harm to the human body. The side surface of the upper tail end of the sealing ring adopts an inclined surface to form a sink groove (the thickness of the sealing ring mouth is greater than the root thickness). This structure increases the gap sealing surface between the sealing ring and the sealing cylinder, thereby improving the sealing effect, better preventing the entry of foreign substances or the leakage of internal substances, ensuring the stability of the internal environment of the implant, and facilitating its normal function.

[0040] The product of the present invention adopts a detachable connection between the bracket shell and the base, and the corresponding one-way fluid control element and positioning locking element are built into the connection, so as to realize the discharge treatment of the metabolic waste generated by the filler after implantation, and to achieve the stable matching of the internal components. The application of the new implant can help establish the microcirculation environment in the bone during the treatment of femoral head necrosis and promote the postoperative healing effect after the implant is applied. In addition, the production cost of the implant is controllable, and it can be modularly mass-produced, and has achieved good results in clinical applications.

[0041] Unique structural connection and positioning design. The detachable connection between the bracket shell and the base, combined with the tail opening as a positioning mounting piece and the polygonal prism with a taper for the base head positioning insert, not only achieves fast and accurate installation and removal, facilitates clinical operation and postoperative maintenance, but also ensures the stability of the implant in the body. This innovative connection and positioning mechanism has made significant progress in the field of bone implants. Compared with the traditional single connection method, it can better adapt to the complex human physiological environment and improve the overall performance of the implant.

[0042] A containment sealing structure that prevents foreign particles from invading the human body. The chip groove (i.e., the sealed annular space formed by the positioning mounting piece, the sealing ring, and the positioning insert) can effectively collect material wear particles generated by the support housing and the base during the use of the matching connection, especially PEEK material particles. Since PEEK material particles are not biodegradable, they may have adverse consequences if they enter the human tissue circulation. The chip groove can prevent these particles from invading the internal tissues of the human body and avoid potential harm to the human body. The side surface of the upper tail end of the sealing ring adopts an inclined surface to form a groove (the thickness of the sealing ring mouth is greater than the thickness of the root). This structure increases the gap sealing surface between the sealing ring and the sealing cylinder, thereby improving the sealing effect, better preventing the entry of foreign matter or the leakage of internal matter, ensuring the stability of the internal environment of the implant, and facilitating its normal function.

[0043] The efficient fluid suction and management system uses the fluid suction components on the base, the return fluid path composed of the expansion channel, the drainage channel and the negative pressure channel, and the unique structural design of each channel (such as the thick and thin section design of the expansion channel, the diameter control of the drainage channel, the layout of the negative pressure channel and the columnar negative pressure cavity, etc.), to achieve efficient discharge of accumulated fluid and gas and pressure release functions, and has a one-way flow characteristic to effectively prevent the invasion of external harmful substances. The system is innovative in both design concept and function realization, and significantly improves drainage efficiency and safety compared to traditional bone implant drainage methods.

[0044] Diverse selection of fillers and matching filling methods. We provide a variety of filler options, including autologous bone, allogeneic bone, artificial bone and bioactive materials, and design corresponding filling operation methods for different fillers, such as instrument filling of granular fillers and syringe injection of colloidal fillers, while using a special bone implant presser to ensure filling quality. This diverse selection of fillers and refined filling operation design meet the needs of different patients and clinical scenarios, and reflect the optimization of individual functional needs of bone implants. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] Figure 1-2 Stereoscopic image of stent implant;

[0046] Figure 3Base stereogram;

[0047] Figure 4 Structural diagram of sealing ring and reinforcing ribs;

[0048] Figure 5 A cross-sectional diagram of the assembly relationship of the components of the stent implant;

[0049] Figure 6 Schematic diagram of the cross section rotated 90 degrees;

[0050] Figure 7 Schematic diagram of coordination relationship;

[0051] Figure 8 Schematic diagram of the bracket housing;

[0052] Fig. 9 Bone graft depressor;

[0053] Figure 10-11 How to use the suppressor.

[0054] In the figure: the bracket shell 1, the porous part 11, the tail end connecting part 12, the inner cavity 13, the tail end opening 14, the sealing ring 121, the reinforcing rib 122, the base 2, the positioning insert 21, the sealing cylinder 210, the converging trough 212, the expansion channel 22, the drainage channel 23, the radial trough 232, the negative pressure channel 24, the cylindrical negative pressure cavity 242, the trough 31, and the chip space 32. DETAILED DESCRIPTION

[0055] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0056] Figure 1 The bracket assembly state is shown. The bracket comprises: a bracket housing 1 and a base 2. The bracket is provided as a support implant and can be inserted into a surgical site (such as a hole in a bone), and in the specific example here, inserted into the femoral head. It should be noted that after the support implant is inserted into the bone, its inner side is called the head end, and the outer side is called the tail end.

[0057] like Figure 8As shown, the bracket shell 1 includes a porous portion 11 in the middle and a tail end connecting portion 12. The porous portion 11 can be a porous material with interconnected gaps made by 3D metal printing. The connecting portion 12 is arranged at the tail end of the porous portion 11. The connecting portion 12 of the bracket shell 1 has a tail end opening 14, and the tail end opening 14 is connected to the internal cavity of the bracket shell 1. The internal filler can be placed into the internal cavity of the bracket shell 11 through the tail end opening 14.

[0058] The support shell 11 is cup-shaped and forms a longitudinally extending inner cavity 13. The porous portion 11 has a cylindrical outer wall and a cylindrical inner wall, and the cylindrical inner wall defines the inner cavity 13 and is made of a porous material. The relatively elastic properties of the porous material enable the support shell 11 to produce a slight deformation.

[0059] The inner cavity 13 of the stent shell 11 can be filled with the following fillers, such as healthy autologous bone, allogeneic bone, artificial bone, bioactive materials, etc., to promote the repair of surrounding bones; autologous bone can be selected from the bone tissue material drilled during the main surgery, and through backfilling application, intraoperative loss can be avoided, and the use of autologous bone is helpful for bone repair. Artificial bone induction materials can be selected from artificial bone synthesized by "collagen + sodium alginate + nano-hydroxyapatite", artificial bone synthesized by "collagen + nano-hydroxyapatite", hydroxyapatite (HA), tricalcium phosphate (TCP), bidirectional calcium phosphate (BCP) One or more. Bioactive materials use, for example, platelet-rich plasma (PRP) and the like.

[0060] The filler can be in granular form and filled into the inner cavity 13 of the stent by an instrument. The instrument is operated to apply a compressive force to compact the filler. The filler can also be processed into a colloid state and injected into the inner cavity 13 by a syringe, and then solidified. After the filler is compacted or solidified in the inner cavity 13, sufficient mechanical strength is formed. The porous material is elastic, and under the elastic force generated by the slight deformation, it can ensure that the stent shell 11 will tightly wrap and press the internal filler, and the covering effect of the stent shell 11 forms a complete implant.

[0061] The connecting portion 12 of the bracket housing 1 is made of solid material. The bracket material may also be tantalum, titanium-tantalum alloy, nickel-titanium alloy, pure titanium, or cobalt alloy. Figure 7 As shown, the tail end opening 14 of the connection portion 12 of the bracket housing 1 also serves as a positioning and mounting member, and is positioned and mounted with the base 2. The tail end opening 14 forms a polygonal prism. The prism has a certain taper.

[0062] The support further includes a base 2, which is a solid material. The material of the base 2 can be PEEK material. The outer surface of the base 2 can be provided with threads or a rough surface to increase the friction between the bone and the support body during implantation, thereby facilitating a stronger attachment of the support body to the bone. A concave hole or groove is designed on the bottom end surface of the base 2 for connecting with an external instrument for surgical operation.

[0063] Figure 3 As shown, a positioning insert 21 is provided at the head end of the base 2, and the positioning mounting piece of the connecting portion 12 is connected with the positioning insert 21 at the head end of the base 2. The positioning insert 21 also forms a polygonal prism. The prism has a certain taper, and the taper of the positioning mounting piece of the connecting portion 12 is consistent with that of the positioning insert 21 at the head end of the base 2. When the positioning mounting piece is matched with the positioning insert 21 for installation, the polygonal profile can be axially guided and rotation can be restricted. With a tapered structure, the insertion length can be limited and positioned in the axial direction. That is, it is limited in the length direction. After the positioning mounting piece and the positioning insert 21 are matched and installed, a matching positioning is formed between the tapered profiles of the two.

[0064] The stent shell and the base are connected in a detachable manner. The opening at the rear end of the stent shell is used as a positioning mounting piece and cooperates with the polygonal prism with a taper of the positioning insert at the head end of the base. This not only achieves fast and accurate installation and removal, facilitates clinical operation and postoperative maintenance, but also ensures the stability of the implant in the body. This detachable connection and positioning mechanism is a significant innovation in the field of bone implants. Compared with the traditional single connection method, it can better adapt to the complex physiological environment of the human body and improve the overall performance of the implant.

[0065] The connecting portion 12 of the bracket housing 1 is made of solid material. The bracket can also be made of tantalum, titanium-tantalum alloy, nickel-titanium alloy, pure titanium, cobalt alloy and the like. The base 2 can be made of PEEK material or metal material. When the base is made of PEEK material, the material properties of the positioning mounting piece and the positioning insert 21 are different. When the base is made of metal material, the material properties of the positioning mounting piece and the positioning insert are the same or different.

[0066] When the support shell 1 and the base 2 are matched as a whole and implanted in the bone, the base 2 is attached to the outer cortical bone, while the support shell 1 is in the interstitial bone. The support is also subjected to external pressure. When the support shell 1 and the base 2 are positioned with a tapered structure, a slight sliding displacement and friction will occur between the surfaces of the positioning mounting part and the positioning insert 21. Although a smaller roughness can be formed on the mating surfaces of the two by processing to reduce the friction, it is inevitable that friction will occur between the mating surfaces of the positioning mounting part and the positioning insert 21 to produce material wear particles.

[0067] The wear debris produced after implantation is very harmful and can cause an inflammatory response after entering the human body. After the immune system recognizes the wear debris, macrophages release inflammatory factors, causing local redness, swelling, pain, and fever. Long-term inflammation can also cause chronic tissue damage, affect the activity of osteoblasts in the femoral head, and destroy bone. Wear debris can also directly damage tissues, embed into soft tissues and affect their functions, interfere with bone repair and reconstruction, cause bone dissolution, and increase the risk of fractures.

[0068] When the base is made of PEEK material, the harder positioning mounting piece will also cause wear to the positioning insert 21 and generate PEEK material particles. The wear particles of the materials generated by the positioning, especially the PEEK material, do not have biodegradable properties.

[0069] When the porous part 11 of the stent shell 1 is made of porous material, the wear particles of the material may enter the human tissue circulation, causing adverse consequences. It is necessary to prevent the invasion of the wear particles of the material from the structure.

[0070] like Figure 3 , 4 As shown, a sealing ring 121 is formed at the head end of the positioning mounting member of the connection part 12, and the sealing ring 121 is integrated with the connection part 12 and is also made of solid material. A sealing cylinder 210 is formed at the head end of the positioning insert 21, and the sealing cylinder 210 passes through the sealing ring 121. A gap seal is formed between the side surface of the ring opening of the sealing ring 121 and the surface of the sealing cylinder 210, and a seal can be formed by using the machining matching gap when the two slide relative to each other.

[0071] When the sealing cylinder 210 of the positioning insert 21 passes through the sealing ring 121 of the positioning mounting member, a closed space is formed by the positioning mounting member, the sealing ring 121 and the positioning insert 21 as a chip space 32. The space is not connected to the internal tissues of the human body, and the material wear particles can stay in the space to prevent the material particles from invading the internal tissues of the human body.

[0072] like Figure 8 As shown, further, a sink groove 31 is formed on the side surface of the upper tail end of the sealing ring 121, so that material particles are more likely to stay and accumulate. The side surface of the upper tail end of the sealing ring 121 adopts an inclined surface, and the ring mouth thickness of the sealing ring 121 is greater than the root thickness, that is, the sink groove 31 is formed at the root of the sealing ring 121. The ring mouth thickness of the sealing ring 121 is relatively large, and the gap sealing surface with the sealing cylinder 210 is relatively large, thereby also improving the sealing effect.

[0073] By designing the taper and length dimensions, the depth of the tail end opening 14 as a positioning mounting piece is greater than the length of the positioning insert 21. Therefore, after the positioning mounting piece and the positioning insert 21 are positioned together, mutual contact and pressure are formed between the tail end of the connecting part 12 and the base 2, and at the same time, there is enough space at the head end of the connecting part 12 to form a closed chip space 32.

[0074] like Figure 4 , 8 As shown, further, in order to form a structural fusion between the porous material and the solid material between the porous portion 11 and the tail end connecting portion 12, the sealing ring 121 extends toward the head end with a plurality of strip-shaped reinforcing ribs 122, the reinforcing ribs are connected to the sealing ring and integrated with the connecting portion, and a connection relationship is formed with the porous portion 11 through the reinforcing ribs 122, so that a stable connection is formed between the porous material and the solid material.

[0075] The filler in the inner cavity 13 of the stent shell 1 will exchange nutrients with the surrounding bone tissue through the porous material, and the bone tissue will grow and fill the inside of the stent. The physiological waste gas and waste liquid generated in this process need to be discharged in time. Since the implanted part of the stent lacks normal bone tissue, the waste gas and waste liquid cannot be absorbed and excreted from the human body physiologically. The pressure generated by excessive waste gas and waste liquid will cause physiological discomfort and affect the recovery and growth of bone tissue, and needs to be discharged in time.

[0076] A fluid suction component is disposed on the base 2. Figure 5 , 6 As shown, the fluid suction assembly includes an expansion channel 22, a drainage channel 23 and a negative pressure channel 24. The two expansion channels 22 and the two negative pressure channels 24 are arranged in a cross shape, and the drainage channel 23 is in the center.

[0077] The sealing cylinder 210 end surface of the positioning insert 21 at the head end of the base 2 has a confluence sink 212, which is an annular sink. The expansion channel 22 is a pair of through holes symmetrically arranged along the axis of the base 2, which are divided into a thinner section at the head end and a thicker section at the tail end. The head end opens at the bottom of the confluence sink 212, and the waste gas and waste liquid generated in the filler can be converged in the confluence sink 212 and input into the expansion channel 22.

[0078] The thicker section of the expansion channel 22 is used to provide a larger waste gas and waste liquid accommodation space, and the thinner section is used to provide reverse flow resistance to prevent the waste gas and waste liquid from flowing back. The thicker section is more than 3 times the length of the thinner section, and the diameter ratio of the thicker section to the thinner section is more than 3 times.

[0079] like Figure 1 As shown, the expansion channel 22 forms an opening at the tail end of the base 2. The tail end opening is convenient for processing the channel and internal cleaning. When implanted, the tail end opening surface is closed by a matching piece. A drainage channel 23 is formed in the center of the base 2. The drainage channel 23 is located at the axis of the base 2. It has a thinner diameter than the thick section of the expansion channel 22, and the diameter ratio of the two is more than 3 times. The tail end of the drainage channel 23 is open, and the tail end opening is connected to the expansion channels 22 on both sides through the radial sink groove 232.

[0080] During negative pressure drainage, the waste gas and waste liquid in the expansion channels 22 on both sides can enter the drainage channel 23 through the radial sink grooves 232 and eventually drain out of the body. When negative pressure drainage is not applied, the thinner diameter of the drainage channel 23 also prevents the waste gas and waste liquid from directly overflowing into the drainage channel 23. During implantation, the surface of the radial sink groove 232 is sealed by a matching piece.

[0081] like Figure 6 As shown, a pair of negative pressure channels 24 are symmetrically arranged at a position rotated 90 degrees from the expansion channel 22. The tail end of the negative pressure channel 24 is open, and the head end thereof is connected to a radially arranged cylindrical negative pressure cavity 242. The negative pressure channels 24 on both sides are respectively opened at the two ends of the cylindrical negative pressure cavity 242, and the head end of the drainage channel 23 is opened in the middle position of the cylindrical negative pressure cavity 242.

[0082] The tail openings of the negative pressure channels 24 on both sides can be connected to the outside of the human body through external pipes. The support implant has a fluid suction and management function system, which utilizes the fluid suction component on the base, the reentrant fluid path composed of the expansion channel, the drainage channel and the negative pressure channel, and the unique structural design of each channel (such as the thick and thin section design of the expansion channel, the diameter control of the drainage channel, the layout of the negative pressure channel and the columnar negative pressure cavity, etc.), to achieve the integration of efficient effusion, gas discharge and pressure release functions on the implant. The expansion channel facilitates the exudation and temporary retention of tissue metabolites, the drainage channel is used to discharge the temporary retained substances, the negative pressure channel and the columnar negative pressure cavity provide external negative pressure power, and various functional units are formed on the reentrant fluid path, and a diameter control node is provided to realize the one-way flow characteristics, effectively preventing the invasion of external harmful substances.

[0083] When the external pipe is connected to the external negative pressure drainage device, a negative pressure space is formed in the columnar negative pressure cavity 242, so that the waste gas and waste liquid in the expansion channel 22 are led out through the drainage channel 23. When implementing negative pressure drainage, the negative pressure drainage device can be connected to the negative pressure channels 24 on both sides at the same time, and the negative pressure channels 24 on both sides apply the same negative pressure at the same time. The negative pressure channels 24 on both sides can also be connected to apply different pressures. Due to the pressure difference on both sides, an internal fluid field is formed in the columnar negative pressure cavity 242. When the internal fluid field passes through the columnar negative pressure cavity 242, it will also produce an ejection effect on the opening of the drainage channel 23, thereby strengthening the drainage effect on the head end of the drainage channel 23.

[0084] When a drainage scheme that applies different pressures is adopted, the columnar negative pressure chamber 242 can also adopt a conical column chamber, whose fluid inlet side diameter is smaller and the fluid outlet side diameter is larger. When the fluid passes through the conical column negative pressure chamber, fluid diffusion will occur, further enhancing the drainage effect on the head end of the drainage channel 23.

[0085] The filling material is filled in the inner cavity 13 of the stent; the filling material can be pre-compacted and pre-cured by using an instrument; Figure 9-11As shown, a bone grafting presser used in conjunction with the stent is also included, and the bone grafting presser can be used to compress the filling material in the inner cavity 13 of the stent.

[0086] The bone grafting suppressor has a handle portion and a pressure portion, and one end of the handle portion is fixedly connected to the pressure portion. The handle portion is a long cylindrical body, which is used for the operator to hold and apply force. The end of the handle portion is used to fill and pressurize the inner cavity 13. When filling in the inner cavity 13, the end of the handle portion is used to pre-tighten the filling material. When the filler is almost done filling the inner cavity 13, it is necessary to fill a certain depth inside the positioning mounting piece, and the pressure portion needs to be used. The pressure portion is a polygonal conical column, and its outer surface forms a structure that is pressure-matched with the positioning mounting piece. When the pressure portion is inserted into the positioning mounting piece, the bottom surface can press the filling material and form a top plane of the filling material, and the top plane of the filling material can form a complete match with the top surface of the positioning insert 21 of the base 2.

[0087] In actual applications, a variety of filler options are available, including autologous bone, allogeneic bone, artificial bone and bioactive materials, etc., and corresponding filling operation methods are designed for different fillers, such as filling granular fillers with instruments and injecting colloidal fillers with syringes, while using a special bone grafting presser to apply pressure to ensure the filling quality.

[0088] The tail opening of the expansion channel 22 and the radial sink 232 are sealed by matching parts; the tail opening of the negative pressure channel 24 is connected to the external pipe. The surgical incision is sutured. The connected external pipe is connected to the outside of the human body. When negative pressure drainage is required, the external pipe is connected to the drainage device to perform various drainage operations.

[0089] Furthermore, the fluid circulation pathway in the implant can be combined with the postoperative oxygen supply and exhaust system to promote blood vessel growth in the stent and the lesion area, achieve reconstruction of the oxygen circulation system in the lesion area, provide the new bone tissue with the required stem cells, oxygen, nutrients, growth factors, and remove local metabolic waste.

[0090] In addition, the various parts of the stent can be prepared by 3D printing technology, or by non-3D printing technology (such as subtractive manufacturing, vapor deposition or sintering, etc.). The stent can be processed into any other shape as needed. The stent is a porous titanium alloy stent, and the material of the stent can also be tantalum, titanium-tantalum alloy, nickel-titanium alloy, pure titanium, cobalt alloy, calcium phosphate, hydroxyapatite, polylactic acid (PLA), lactic acid-glycolic acid copolymer (PLGA), polyacetic acid lactone (PCL), coral or bioceramics and other materials.

[0091] Finally, it should be noted that the above description is only an explanation of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail, those skilled in the art can still modify the technical solutions described above or replace some of the technical features with equivalents. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A chip-containing negative pressure drainage bone implant, comprising a support shell and a base, characterized in that: The inner cavity of the bracket shell is filled with a filling material; the bracket shell and the base are detachably connected. The bracket shell has a rear end opening, and the rear end opening is connected to the inner cavity of the bracket shell; The internal filler can be placed into the internal cavity of the stent shell through the tail end opening; A fluid suction component is disposed on the base; The tail end opening is used as a positioning installation piece, the head end of the base is provided with a positioning insert, and the positioning installation piece of the bracket shell forms a surface matching connection with the positioning insert of the head end of the base; The positioning installation piece and the positioning insert piece form a sealed annular space at the head end position, and the wear particles generated by the positioning installation piece and the positioning insert piece during the matching connection use are collected in the sealed annular space.

2. The chip-containing negative pressure drainage bone implant according to claim 1, characterized in that: The bracket shell includes a porous part and a tail end connecting part. The porous part is a porous material with overall gaps connected, and the tail end connecting part is a solid material, and the two are integrated; the positioning mounting piece is formed on the tail end connecting part.

3. The chip-containing negative pressure drainage bone implant according to claim 2, characterized in that: The positioning insert is integrally formed with the base.

4. The chip-containing negative pressure drainage bone implant according to claim 3, characterized in that: The head end of the connection part positioning installation piece forms a sealing ring, which is integrated with the connection part and made of solid material; the head end of the positioning insert forms a sealing cylinder, which passes through the sealing ring, and a gap seal is formed between the ring mouth side of the sealing ring and the surface of the sealing cylinder.

5. The chip-containing negative pressure drainage bone implant according to claim 4, characterized in that: The depth of the positioning installation piece is greater than the length of the positioning insert. After the positioning installation piece and the positioning insert are positioned together, a sealed annular space is formed by the positioning installation piece, the sealing ring and the positioning insert.

6. The chip-containing negative pressure drainage bone implant according to claim 5, characterized in that: A groove is formed on the side surface of the tail end of the sealing ring, and the wear particles of the material stay and accumulate in the groove.

7. The chip-containing negative pressure drainage bone implant according to claim 6, characterized in that: The side surface of the upper tail end of the sealing ring adopts an inclined surface, that is, the thickness of the ring mouth of the sealing ring is greater than the thickness of the root, and a sink groove is formed at the root of the sealing ring; The thickness of the sealing ring is relatively large, and the gap sealing surface with the sealing cylinder is relatively large, thereby improving the sealing effect.

8. The chip-containing negative pressure drainage bone implant according to claim 4, characterized in that: The sealing ring has a plurality of strip-shaped reinforcing ribs extending toward the head end, and is connected to the porous part through the reinforcing ribs.

9. The chip-containing negative pressure drainage bone implant according to claim 4, characterized in that: The fluid suction assembly includes an expansion channel, a drainage channel and a negative pressure channel; The expansion channel is a through hole, the head end of which opens on the top surface of the sealing cylinder, and the expansion channel forms an opening at the tail end of the base; A drainage channel is formed at the center of the base, and the drainage channel is located at the axis of the base; The negative pressure channel opens at the rear end of the base, and its head end is connected to a radially arranged cylindrical negative pressure cavity; The cylindrical negative pressure cavity is connected to the head end of the drainage channel.

10. The chip-containing negative pressure drainage bone implant according to claim 1, characterized in that: The positioning mounting piece and the positioning insert piece are polygonal prisms, the prisms have a certain taper, and the tapers of the two are consistent.

Images