Tail-filled bone implant capable of realizing negative pressure drainage

Abstract

A tail-filled 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, the support shell is provided with a tail end opening, 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; one end of the fluid suction assembly is opened at the head end of the base and communicated with the cavity in the support shell, the other end is opened at the tail end of the base and communicated with the outside of a human body, and the middle forms a turn-back type fluid passage in the base; the implant can adapt to a complex human physiological environment, and the overall performance of the implant is improved; the internal stress self-adaptive adjusting structure promotes growth and integration of bone tissues and adapts to individual differences of different patients; the efficient fluid suction and management function system realizes efficient effusion and pneumatosis discharge and pressure release functions; different clinical requirements are met through diversified filler selection and adaptive filling methods.

Description

Technical Field

[0001] The present invention relates to medical devices, and more specifically, to an implant for bone reconstruction, in particular to a tail-filled 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 stage, 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 in 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 affected area in the bone is not effectively treated and controlled, the fluid and gas are likely to reappear, and the disease may even progress further.

[0006] 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.

[0007] Therefore, there is an urgent need to develop a bone implant that can effectively remove necrotic tissue, provide reliable mechanical support, promote bone integration, rebuild bone microcirculation, continuously reduce intraosseous pressure, and facilitate 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, convenient 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

[0008] The purpose of the present invention is to overcome the deficiencies of the prior art and provide a bone implant that can discharge the fluid and gas accumulation after bone necrosis, continuously reduce the intraosseous pressure, eliminate the need for intraosseous puncture, reduce the risk of infection, have long-lasting stability, good biocompatibility, and perfectly adapt to different populations. The production cost of the implant is controllable, modular mass production is possible, and good results are achieved in clinical applications.

[0009] Provide a new product structure design.

[0010] A tail-filled negative pressure drainage bone implant comprises a support shell and a base, wherein the inner cavity of the support shell is filled with a filler 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] One end of the fluid suction component opens at the head end of the base and communicates with the internal cavity of the support shell, and the other end opens at the tail end of the base and can be connected to the outside of the human body, forming a return fluid passage in the base in the middle.

[0015] Furthermore, the tail end opening also serves as a positioning mounting piece, which is positioned and mounted with the base; the tail end opening forms a polygonal prism, and the prism has a certain taper; a positioning insert is provided at the head end of the base, and the positioning mounting piece of the bracket shell is connected with the positioning insert at the head end of the base; the positioning insert also forms a polygonal prism, and the prism has a certain taper, and the positioning mounting piece of the bracket shell is consistent in taper with the positioning insert at the head end of the base.

[0016] Furthermore, the bracket shell includes a middle porous portion and a tail end connecting portion, and the porous portion and the tail end connecting portion can be porous materials with interconnected gaps made by 3D metal printing.

[0017] Furthermore, the insertion depth of the positioning insert is less than its height, that is, after the positioning insert is fully inserted and positioned, a certain free gap is formed between the bracket shell connecting part and the base; the elastic porous material bracket shell cooperates with the free gap to form an internal stress retention structure of the bracket.

[0018] Furthermore, an elastic ring may be installed at the free gap to adjust and compensate for the elastic performance of the bracket shell.

[0019] Furthermore, the elastic ring is made of elastic polymer silicone material, its inner hole is sleeved on the root of the positioning insert, its outer diameter is equal to the outer diameter of the bracket shell, and its two side surfaces are in contact with the connecting part and the base.

[0020] Further, the fluid suction assembly includes an expansion channel, a drainage channel and a negative pressure channel;

[0021] The expansion channel is a through hole, the head end of which opens on the top surface of the positioning insert, and the expansion channel forms an opening at the tail end of the base;

[0022] A drainage channel is formed at the center of the base, and the drainage channel is located at the axis of the base;

[0023] 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;

[0024] The cylindrical negative pressure cavity is connected to the head end of the drainage channel.

[0025] Furthermore, the drainage channel opens at the rear end of the base, and the rear end opening is connected to the expansion channel through a radial sink groove.

[0026] Furthermore, the expansion channel is divided into a thinner section at the head end and a thicker section at the tail end; the drainage channel has a thinner diameter relative to the thick section of the expansion channel.

[0027] Furthermore, a pair of negative pressure channels are symmetrically arranged, the negative pressure channels on both sides are opened at the two ends of the cylindrical negative pressure cavity respectively, and the head end of the drainage channel is opened at the middle position of the cylindrical negative pressure cavity;

[0028] The tail end openings of the negative pressure channels on both sides can be connected to the outside of the human body through external pipes.

[0029] Product structure design configuration internal stress regulation and optimization of some structures:

[0030] The insertion depth of the positioning insert is carefully designed to be less than its own height. When the positioning insert is fully inserted and precisely matched with the positioning mounting piece of the bracket shell, a certain free gap will naturally form between the bracket shell connection part and the base. In this free gap area, the bracket shell is not provided with an additional supporting structure, so that it can be elastically deformed when subjected to external pressure. Since the inner wall surface of the connection part is restricted by the tapered structure, and the outer side surface located at the free gap is in a free movable state, when the bracket shell is implanted into the bone tissue and subjected to external pressure, relative displacement deformation will occur between the inner and outer structures of the connection part, thereby generating an elastic force. This elastic force will be evenly transmitted through the bracket shell and applied to the surrounding bone tissue, forming an internal stress retention structure. Under the continuous internal stress, it can effectively stimulate the surrounding bone tissue to grow, integrate and recover well, and promote the formation of a tight and stable combination between the bone tissue and the implant.

[0031] In order to further optimize the performance of the stent shell, the inner side of the connection part can be reasonably processed to form reinforcing ribs of partially solid materials. The main function of these reinforcing ribs is to enhance the structural strength of the inner wall of the connection part, so that it can more reliably form a stable positioning and matching relationship with the positioning insert, while not adversely affecting the free movement performance of the outer side of the connection part. In addition, in order to flexibly adjust the elastic performance of the stent shell according to the specific needs of different patients, an elastic ring is innovatively installed at the free gap. The elastic ring is made of elastic polymer materials, such as silicone materials. Its unique structural design enables its inner hole to be tightly fitted on the root of the positioning insert, while the outer diameter is precisely equal to the outer diameter of the stent shell, and the two sides can fully contact the connection part and the base. In this way, the elastic ring can exert precise elastic force on the outer part of the connection part, thereby achieving effective adjustment and compensation of the elastic performance of the stent shell, ensuring that the implant can adapt to the individual differences of different patients and provide personalized treatment effects.

[0032] Designing efficient fluid pumping system parts:

[0033] An advanced fluid suction component is integrated on the base, which consists of an expansion channel, a drainage channel and a negative pressure channel. The three are arranged in a carefully designed cross and work together to achieve efficient fluid management functions.

[0034] The expansion channel is designed as a through hole, and its head end is cleverly opened in the confluence sink on the top surface of the positioning insert. The confluence sink is a circular sink structure, which can effectively collect the waste gas and waste liquid generated from the inside of the filler and guide it to flow smoothly into the expansion channel. The expansion channel is further divided into a thinner section at the head end and a thicker section at the tail end. This unique structural design has multiple functions. The main function of the thicker section is to provide a larger space for accommodating waste gas and waste liquid, ensuring that these wastes can be effectively collected and temporarily stored during the drainage process; while the thinner section can provide appropriate reverse flow resistance, effectively avoiding the reflux of waste gas and waste liquid during the drainage process, and ensuring the unidirectionality and stability of the drainage direction. The expansion channel forms an opening at the tail end of the base, which not only facilitates the processing of the channel during the processing process, but also can be sealed with specially designed fittings during the implantation operation to ensure the sealing of the fluid passage when the implant is working normally.

[0035] Fill selection and fill operation optimization:

[0036] The present invention provides a rich variety of filler options to meet the needs of different patients and clinical treatment scenarios. Healthy autologous bone can be selected as the filler, and the autologous bone can be directly selected from the bone tissue material drilled during the main surgery. Through backfilling application, it can not only avoid the loss of bone tissue during the operation, but also utilize the biological properties of the autologous bone itself to help accelerate the bone repair process. In addition, allogeneic bone, artificial bone and various bioactive materials can also be used as alternatives for fillers. 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 of these artificial bone materials have good biocompatibility and osteoinduction properties, and can provide effective scaffolds and guidance for new bone formation. In terms of bioactive materials, such as platelet-rich plasma (PRP), etc., it is rich in a variety of growth factors, which can actively promote cell proliferation, differentiation and tissue repair, and provide strong bioactive support for the regeneration of bone tissue.

[0037] Corresponding filling operation methods are designed for different types of fillers. For granular fillers, they can be filled into the inner cavity of the stent with the help of specially designed instruments. During the filling process, the operating instrument can apply appropriate compression force to make the filler evenly distributed and compacted in the inner cavity of the stent, ensuring that the filler forms a stable structure in the stent, providing a solid foundation for bone tissue growth. For fillers processed into colloids, they can be accurately injected into the inner cavity with a syringe. After injection, the filler will undergo a solidification reaction, thereby forming a stable filling structure in the inner cavity of the stent. Whether it is a granular or colloidal filler, after compression or solidification, it can form sufficient mechanical strength in the inner cavity of the stent, and cooperate with the elastic stent shell to form a complete implant structure. With the elastic characteristics of its porous material, the stent shell can tightly wrap and continuously pressurize the internal filler under the elastic force generated by slight deformation, further enhancing the stability and integrity of the implant.

[0038] In order to ensure the filling quality and uniformity of the filler in the inner cavity of the stent, a matching bone grafting presser is specially designed. The bone grafting presser consists of two parts: a handle and a pressure-applying part, which work together to achieve precise compression of the filler. The handle is designed to be in the shape of a long cylinder, which is convenient for the operator to hold and apply force. In the early stage of filling, the end of the handle can be used to pre-compress the filler material so that the filler initially forms a certain degree of compactness in the inner cavity of the stent. When the filler is about to fill the inner cavity, it is necessary to fill a certain depth of filler inside the positioning mounting part. At this time, the pressure-applying part is used for operation. The pressure-applying part is designed to be in the shape of a polygonal cone, and its outer surface forms a pressure-applying fitting structure that precisely matches the inner surface of the positioning mounting part. When the pressure-applying portion is inserted into the positioning mounting piece, its bottom surface can apply a uniform and effective pressing force to the filling material, so that the filling material forms a top plane inside the positioning mounting piece. The top plane can form a complete and tight fit with the top surface of the base positioning insert, ensuring the stability of the connection between the bracket shell and the base, while also ensuring the uniform distribution and firmness of the filler in the entire bracket cavity, laying a solid foundation for the implant to perform optimally in the body.

[0039] Specifically, the advantages of the present invention are as follows:

[0040] First, it continuously releases intraosseous pressure, effectively relieves pain, and improves quality of life. Excessive intraosseous pressure is an important factor in the progression of femoral head-related diseases. Releasing intraosseous 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 pain caused by increased pressure inside the femoral head, reduce the degree of restriction on their daily activities, restore some work and life abilities, and greatly improve the quality of life of patients.

[0041] Second, it promotes the discharge of effusion and gas accumulation, promotes bone repair, and delays the progression of the disease. 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 accumulation 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 chances of successful hip preservation treatment.

[0042] Third, the fluid suction component design reduces the risk of infection and maintains joint health. The fluid component has the characteristics of one-way flow. While releasing pressure and discharging accumulated fluid and gas, this design can effectively prevent the reverse invasion of harmful substances such as external bacteria and inflammatory factors, providing a reliable joint health maintenance mechanism for patients who need long-term treatment and management, reducing the risk of treatment failure due to infection, and helping patients maintain good joint function for a long time.

[0043] Fourth, the implant can work stably and long-term, reduce medical costs, and improve treatment compliance. Compared with traditional invasive treatment methods such as repeated puncture and fluid extraction, drug injection, etc., it can reduce the number of patients' frequent medical visits and treatment costs, and improve patient compliance and treatment effects.

[0044] Fifth, from the perspective of surgical operation, the design of this implant fully considers the convenience and safety of the operation. Its simple implantation method and small surgical trauma greatly reduce the burden on the patient's body, allowing the patient to recover faster after surgery. For patients with poor physical conditions and limited tolerance, such as elderly patients with femoral head lesions, the advantages of this implant are more obvious, enabling more such patients to have the opportunity to receive effective treatment, improving the accessibility and safety of treatment.

[0045] Sixth, the implant has good biocompatibility. The implant is made of materials with good biocompatibility and optimized in design to ensure that it will not cause strong immune rejection or inflammatory reactions in the body, which can reduce complications caused by immune reactions and the need for follow-up treatment, so that patients can have a better experience during the treatment process, and it also helps to improve the rehabilitation effect and shorten the rehabilitation cycle. For example, there will be no immune rejection phenomena such as local redness, swelling, fever, and effusion after implantation.

[0046] 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.

[0047] 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. For example, the most suitable implant solution can be provided for patients of different ages, genders, weights, and degrees and ranges of lesions.

[0048] Ninth, multi-system synergy promotes overall recovery. The fluid circulation pathway of the implant can be organically combined with the postoperative oxygen supply and exhaust system. This innovative combination can promote the growth of blood vessels in the stent and the lesion area, and achieve the reconstruction of the oxygen circulation system in the lesion area. By providing the new bone tissue with the required stem cells, oxygen, nutrients, and growth factors, and timely removing and discharging local metabolic waste, the synergy between multiple systems is achieved, which promotes the repair and regeneration of bone tissue from multiple dimensions, comprehensively improves the overall treatment effect, and creates more favorable conditions for the patient's recovery.

[0049] The product of the present invention adopts a detachable connection between the support shell and the base, and has a corresponding one-way fluid control element built in it, which realizes the discharge treatment of metabolic waste generated by the filler after implantation, and can achieve stable matching of internal components. The application of the new implant can help establish an intrabone microcirculation environment in the process of treating femoral head necrosis and promote the postoperative healing effect after the implant is applied. The production cost of the implant is controllable, and it can be modularly mass-produced, and has achieved good results in clinical applications.

[0050] 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.

[0051] Internal stress adaptive adjustment structure. The free gap formed by the connection between the positioning insert and the bracket shell, combined with the design of the bracket shell and elastic ring made of elastic porous material, constitutes a unique internal stress maintenance and adjustment structure. This structure can automatically adjust the stress distribution according to the changes in external pressure, promote the growth and integration of bone tissue, and can also achieve personalized elastic performance adjustment through the elastic ring to adapt to the individual differences of different patients. This function of adaptively adjusting internal stress has not been involved in existing bone implants and has outstanding creativity.

[0052] Efficient fluid suction and management system. The fluid suction component on the base has a return fluid pathway consisting of an expansion channel, a drainage channel, and a negative pressure channel, as well as a unique structural design of each channel (such as the design of the thick and thin sections of the expansion channel, the control of the pipe diameter of the drainage channel, the layout of the negative pressure channel and the cylindrical negative pressure cavity, etc.), which realizes efficient discharge of accumulated fluid and gas and pressure release functions, and has a one-way flow characteristic, effectively preventing 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.

[0053] 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

[0054] Figure 1 Stereoscopic image of stent implant;

[0055] Figure 2 Schematic diagram of the bracket housing;

[0056] Figure 3-4 Base stereogram;

[0057] Figure 5 Front view of the rear end of the base;

[0058] Figure 6 Elastic rings;

[0059] Figure 7 A cross-sectional diagram of the assembly relationship of the components of the stent implant;

[0060] Figure 8 Schematic diagram of the cross section rotated 90 degrees;

[0061] Fig. 9 Bone graft depressor;

[0062] Figure 10-11 How to use the suppressor.

[0063] In the figure: the support shell 1, the porous part 11, the tail end connecting part 12, the inner cavity 13, the tail end opening 14, the base 2, the positioning insert 21, the confluence sink 212, the expansion channel 22, the drainage channel 23, the radial sink 232, the negative pressure channel 24, the cylindrical negative pressure cavity 242, the free gap 31, the elastic ring 32, the bone graft suppressor 4, the handle part 41, and the pressure part 42. DETAILED DESCRIPTION

[0064] 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.

[0065] Figure 1 The bracket assembly state is shown in FIG. The bracket includes: a bracket shell 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 the inner side of the support implant in the implanted bone is called the head end, and the outer side is called the tail end.

[0066] The support 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 of the support shell 1 has a tail end opening 14, and the tail end opening 14 is connected to the internal cavity of the support shell 1. The internal filler can be placed into the internal cavity of the support shell 11 through the tail end opening 14.

[0067] The stent housing 1 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, the cylindrical inner wall defining the inner cavity 13, and is made of a porous material. The relative elasticity of the porous material enables the stent housing 1 to produce a slight deformation.

[0068] The inner cavity 13 of the stent shell 1 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.

[0069] 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 compressed 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 1 will tightly wrap and press the internal filler, and the complete implant is formed through the covering effect of the stent shell 1.

[0070] like Figure 2 As shown, the tail opening 14 of the connection part of the bracket housing 1 also serves as a positioning and mounting member, and is positioned and mounted with the base 2. The tail opening 14 forms a polygonal prism. The prism has a certain taper.

[0071] The support further includes a base 2, which is a solid material. The outer surface of the base 2 may be provided with a thread or a rough surface to increase the friction between the bone and the support body when implanted, so as to facilitate the support body to be more strongly attached to the bone. A concave hole or a groove is designed on the bottom end surface of the base 2 for connecting with an external instrument for surgical operation. A positioning insert 21 is provided at the head end of the base 2, and the positioning mounting piece of the connecting part 12 is matched and 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 part 12 is consistent with the taper of the positioning insert 21 at the head end of the base 2. When the positioning mounting piece is matched and installed with the positioning insert 21, the polygonal profile can be axially guided and rotation is restricted. The tapered structure can be used to limit the insertion length 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 taper profiles of the two.

[0072] The bracket shell and the base are connected in a detachable manner. The opening at the rear end of the bracket shell is used as a positioning mounting piece and is tapered with the polygonal prism of the positioning insert at the head end of the base. This not only enables 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.

[0073] like Figure 7 As shown, by designing the taper and length, the insertion depth of the positioning insert 21 is ensured to be less than its height, that is, after the positioning insert 21 is fully inserted and positioned, a certain free gap 31 is formed between the connecting portion 12 and the base 2. The bracket housing 1 at the free gap 31 is not provided with corresponding structural support.

[0074] The connecting part 12 can be a porous material with interconnected gaps made by 3D metal printing. Since the inner wall surface of the connecting part 12 provides limited positioning through the tapered structure, the outer side surface located at the free gap 31 is in a free movable state. When the support shell 1 is implanted in the bone tissue and subjected to external pressure, there is no corresponding supporting force on the outer side surface of the free gap 31, and relative displacement deformation and elastic force are generated between the inner and outer structures of the connecting part 12. The resulting elastic effect will be applied to the surrounding bone tissue through the support shell 1.

[0075] The elastic support shell 1 cooperates with the free gap 31 to form an internal stress retaining structure of the support. When implanted in bone tissue, the support shell 1 can continuously be driven to apply force to the surrounding bone tissue. Under the continuous application of internal stress, the surrounding bone tissue can be stimulated to grow, integrate and recover well.

[0076] Furthermore, reinforcing ribs of partially solid material may be processed on the inner side of the connection portion 12, and the reinforcing ribs may be used to increase the structural strength of the inner wall surface, so that the inner wall surface is more suitable for forming a stable positioning fit with the positioning insert 21 without affecting the free movement performance of the outer side.

[0077] In order to provide improved elastic support, an elastic ring 32 may be further installed at the gap 31. The elastic ring 32 is made of elastic polymer material, such as silicone material, and its inner hole is sleeved at the root of the positioning insert 21. Its outer diameter is equal to the outer diameter of the stent shell 1, and the end surfaces on both sides are in contact with the connecting part and the base 2, thereby applying an elastic support force to the outer part of the connecting part. Through the elastic ring 32, the elastic performance of the stent shell 1 required for compensation can be adjusted and adjusted to suit different patients.

[0078] An internal stress adaptive adjustment structure is formed based on the free gap 31. The free gap formed between the positioning insert and the connection part of the bracket shell can provide deformation space, and further cooperate with the bracket shell of the elastic porous material and the adjustment compensation of the elastic ring to form a unique internal stress maintenance and adjustment structure. This structure can automatically adjust the stress distribution between the bracket shell and the bone tissue according to the change of external pressure. The adaptive stress distribution can promote better growth and integration of bone tissue into the porous material. At the same time, the elastic ring can realize personalized elastic performance adjustment to adapt to the individual differences of different patients.

[0079] 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.

[0080] A fluid suction component is disposed on the base 2. Figure 7 , 8 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. The end surface of the positioning insert 21 at the head end of the base 2 has a confluence sink 212, which is a circular sink.

[0081] The expansion channel 22 is a pair of through holes symmetrically arranged along the axis of the base 2, which is 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. The thicker section of the expansion channel 22 is used to provide a larger waste gas and waste liquid accommodating space, and the thinner section is used to provide reverse flow resistance to avoid reflux of waste gas and waste liquid. The length of the thicker section is more than 3 times that of the thinner section, and the diameter ratio of the thick section to the thin section is more than 3 times.

[0082] like Figure 4 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 fitting. 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 and has a thinner diameter relative to the thick section of the expansion channel 22. 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. When negative pressure drainage is applied, the waste gas and waste liquid in the expansion channels 22 on both sides can enter the drainage channel 23 through the radial sink groove 232, and finally drain out of the body. When negative pressure drainage is not applied, due to the thinner diameter of the drainage channel 23, the waste gas and waste liquid are also prevented from directly overflowing into the drainage channel 23. When implanted, the surface of the radial sink groove 232 is closed by a fitting.

[0083] like Figure 8 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 opened at both ends of the cylindrical negative pressure cavity 242, and the head end of the drainage channel 23 is opened at the middle position of the cylindrical negative pressure cavity 242. The tail end openings of the negative pressure channels 24 on both sides can be connected to the outside of the human body through external pipes.

[0084] The supporting implant is equipped with a fluid suction and management functional system, which utilizes a fluid suction component formed on the base, a reentrant fluid pathway composed of an expansion channel, a drainage channel and a negative pressure channel, and a unique structural design of each channel (such as the thick and thin segment 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 fluid and gas discharge and pressure release functions on the implant. The expansion channel facilitates the infiltration 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, various functional units are formed on the reentrant fluid pathway, and a diameter control node is provided to realize a one-way flow characteristic, thereby effectively preventing the invasion of external harmful substances.

[0085] 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 head end opening of the drainage channel 23, thereby strengthening the drainage effect on the drainage channel 23.

[0086] 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.

[0087] 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;

[0088] like Figure 9-11 As shown, it also includes a bone grafting suppressor 4 used in conjunction with the bracket, and the bone grafting suppressor 4 can be used to compress the filling material in the inner cavity 13 of the bracket. The bone grafting suppressor 4 has a handle portion 41 and a pressure portion 42, and one end of the handle portion 41 is fixedly connected to the pressure portion 42. The handle portion 41 is a long cylindrical body, which is used for the operator to hold and apply force. The end of the handle portion 41 can be used to fill and press the inner cavity 13. When filling in the inner cavity 13, the end of the handle portion 41 is used to pre-press the filling material. When the filler is about to fill the inner cavity 13, it is necessary to fill a certain depth inside the positioning mounting part, and the pressure portion 42 is required. The pressure portion 42 is a polygonal cone column, and its outer surface forms a structure that is pressed and matched with the positioning mounting part. When the pressure portion 42 is inserted into the positioning mounting part, the bottom surface can compress 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.

[0089] 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.

[0090] The tail opening of the expansion channel 22 and the radial sink 232 are also sealed by matching parts; the tail opening of the negative pressure channel 24 is connected to an 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 a variety of drainage operations. Furthermore, the fluid circulation pathway in the implant can be combined with the postoperative oxygen supply and exhaust system to promote the growth of blood vessels in the stent and the lesion area, realize the 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.

[0091] 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.

[0092] 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 tail-filled 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; One end of the fluid suction component opens at the head end of the base and communicates with the internal cavity of the support shell, and the other end opens at the tail end of the base and can be connected to the outside of the human body, forming a return fluid passage in the base in the middle.

2. The tail-filled negative pressure drainage bone implant according to claim 1, characterized in that: The tail end opening also serves as a positioning mounting piece, which is positioned and mounted with the base; the tail end opening forms a polygonal prism, and the prism has a certain taper; a positioning insert is provided at the head end of the base, and the positioning mounting piece of the bracket shell is matched and connected with the positioning insert at the head end of the base; the positioning insert also forms a polygonal prism, and the prism has a certain taper, and the positioning mounting piece of the bracket shell is consistent in taper with the positioning insert at the head end of the base.

3. The tail-filled negative pressure drainage bone implant according to claim 2, characterized in that: The bracket shell includes a porous part and a tail end connecting part. The porous part and the tail end connecting part are porous materials with overall gaps connected, which are made of 3D metal printing.

4. The tail-filled negative pressure drainage bone implant according to claim 3, characterized in that: The insertion depth of the positioning insert is less than its height, that is, after the positioning insert is fully inserted into the positioning fit, a certain free gap is formed between the bracket shell connecting part and the base; the elastic porous material bracket shell cooperates with the free gap to form an internal stress retention structure of the bracket.

5. The tail-filled negative pressure drainage bone implant according to claim 4, characterized in that: An elastic ring can be installed at the free gap to adjust the elastic performance of the bracket shell required for compensation.

6. The tail-filled negative pressure drainage bone implant according to claim 5, characterized in that: The elastic ring is made of elastic polymer silicone material, the inner hole of which is sleeved on the root of the positioning insert, the outer diameter of which is equal to the outer diameter of the bracket shell, and the end faces on both sides are in contact with the connecting part and the base.

7. The tail-filled negative pressure drainage bone implant according to claim 2, 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 positioning insert, 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.

8. The tail-filled negative pressure drainage bone implant according to claim 7, characterized in that: The drainage channel opens at the rear end of the base, and the rear end opening is connected with the expansion channel through a radial sink groove.

9. The tail-filled negative pressure drainage bone implant according to claim 8, characterized in that: The expansion channel is divided into a thinner section at the head end and a thicker section at the tail end; the drainage channel has a thinner diameter relative to the thick section of the expansion channel.

10. The tail-filled negative pressure drainage bone implant according to claim 7, characterized in that: A pair of negative pressure channels are symmetrically arranged, the negative pressure channels on both sides are opened at the two ends of the cylindrical negative pressure cavity respectively, and the head end of the drainage channel is opened at the middle position of the cylindrical negative pressure cavity; The tail end openings of the negative pressure channels on both sides can be connected to the outside of the human body through external pipes.

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