Filled bone implant for promoting pressure release

Abstract

A filling type bone implant capable of promoting pressure release 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 a one-way fluid control element is arranged at the joint of the support shell and the base. The one-way fluid control element inlet is communicated with the inner cavity, and the one-way fluid control element outlet is communicated with external environment or instrument equipment; the novel implant is applied, in the process of treating femoral head necrosis, the internal pressure of the femoral head can be reduced, and an intraosseous circulation environment can be established.

Description

Technical Field

[0001] The present invention relates to medical devices, and more specifically, to an implant for bone reconstruction, in particular a filling 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 of improving 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 implantation, fluid and gas will accumulate inside the femoral head. The way to discharge needs to be comprehensively judged according to the amount of fluid, the cause 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 the conservative treatment is not effective, invasive operations may be required. For example, joint puncture and fluid extraction, the fluid and gas are directly extracted from the body, and drugs such as glucocorticoids and sodium hyaluronate can be injected into the joint cavity to reduce inflammation and improve joint function. There is a risk of infection in joint puncture surgery, and the surrounding blood vessels, nerves and other tissues may be damaged during the puncture. And this operation requires repeated punctures, which may cause the joint capsule to loosen and affect the stability of the joint to a certain extent. In addition, this operation is only symptomatic treatment. If the root cause of fluid and gas is not effectively treated and controlled, fluid and gas are likely to reappear, and the condition may even progress further.

[0006] In addition, from a production perspective, the production process of this type of support implant is very cumbersome. Due to its complex design, it requires precise manufacturing processes and advanced production equipment, including CAD / CAM technology, CNC machining, additive manufacturing equipment, etc. In addition, the material selection and processing of the implant also need to be strictly controlled to ensure product quality and functional stability. However, due to the complexity of the production process, the production process is uncontrollable, and there are certain production costs and quality control difficulties. This leads to poor economic feasibility of the product, which is not conducive to promotion and application.

[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, 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 bone implant that can be used to discharge fluid and gas accumulation after bone necrosis, continuously reduce intraosseous pressure, eliminate the need for intraosseous puncture, reduce infection risks, 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.

[0010] A filling bone implant that promotes pressure release includes a support shell and a base, characterized in that the inner cavity of the support shell is filled with a filling material; the support shell and the base are detachably connected, and a one-way fluid control element is provided at the connection between the two; the inlet of the one-way fluid control element is connected to the inner cavity, and the outlet of the one-way fluid control element is connected to the external environment or instruments and equipment.

[0011] Furthermore, an opening is formed at the head end of the stent shell, and the filler material is placed into the inner cavity through the opening.

[0012] Furthermore, a crown-shaped end is buckled at the opening.

[0013] Furthermore, a fluid through hole is formed on the bottom of the inner cavity of the bracket shell, the inlet of the fluid through hole is connected to the inner cavity, and the outlet thereof is connected to the inlet of the one-way fluid control element.

[0014] Furthermore, the one-way fluid control element is detachably placed in the main accommodating cavity in the base, and its outlet is connected with the passage in the base to form an external outlet.

[0015] Furthermore, there are a plurality of fluid through holes, and a confluence sink is formed on the outer side surface of the bottom of the inner cavity. The plurality of fluid through holes are connected through the confluence sink and further connected to the inlet of the one-way fluid control element.

[0016] Furthermore, a positioning locking assembly is provided at the connection between the bracket shell and the base.

[0017] Furthermore, the positioning locking assembly includes a positioning recess and a positioning column; the positioning recess is formed on the bottom end surface of the inner cavity of the bracket shell, and the positioning column is located in the auxiliary accommodating cavity in the base; the positioning column has an internal elastomer and a head protrusion, and the head protrusion is pressed into the positioning recess.

[0018] Furthermore, the auxiliary accommodating chamber is arranged to partially overlap with the main accommodating chamber, and the positioning column in the auxiliary accommodating chamber applies a pressing force to the one-way fluid control element in the main accommodating chamber.

[0019] Furthermore, a fluid passage is processed inside the one-way fluid control element, and the fluid passage adopts a Tesla valve type.

[0020] Specifically, the advantages of the present invention are as follows:

[0021] First, continuous release of intraosseous pressure. Excessive intraosseous pressure is an important factor in the progression of femoral head-related diseases. Releasing intraosseous pressure through this implant can help relieve 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, and restore some work and life abilities.

[0022] Second, it promotes the discharge of effusion and gas accumulation. 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.

[0023] Third, the implant is based on the Tesla valve principle and has the characteristics of one-way flow. While releasing pressure and fluid 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 require long-term treatment and management, this helps maintain the health of the joints.

[0024] Fourth, if the implant can function stably and over a long period of time, compared with traditional invasive treatments 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.

[0025] Fifth, from the perspective of surgical operation, the surgical implantation of this implant is simple, less invasive, less burdensome to the patient's body, and the recovery time after surgery is also shortened. This is especially important for patients with poor physical condition and limited tolerance, as it allows more patients to have the opportunity to receive effective treatment. For example, elderly patients with femoral head lesions can also tolerate surgery better.

[0026] 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.

[0027] 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.

[0028] 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.

[0029] The present invention adopts a detachable connection between the support 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 realize 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. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 -2 Stereoscopic image of stent implant;

[0031] Figure 3-4 Schematic diagram of the assembly relationship of the components of the stent implant;

[0032] Figure 5 Front view of the head end of the bracket housing;

[0033] Figure 6 Schematic diagram of the coronal end;

[0034] Figure 7 View of the rear end of the bracket housing;

[0035] Figure 8 Cross-sectional view of the rear end of the bracket housing;

[0036] Fig. 9 Schematic diagram of positioning column;

[0037] Fig.10 A three-dimensional diagram of a one-way fluid control element;

[0038] Fig.11 A cross-sectional view of a one-way fluid control element;

[0039] Fig.12 Base stereogram;

[0040] Fig.13 Cross-sectional view of the base;

[0041] Figure 14-15 Cross-sectional view of stent implant assembly;

[0042] Fig.16 Stereoscopic diagram of the suppressor;

[0043] Fig.17 Cross-sectional view of the suppressor;

[0044] Fig.18 Cross-sectional view of the pressure device;

[0045] In the figure: 1 support shell; 2 base; 3 coronal end; 4 positioning locking element; 5 one-way fluid control element; 11 porous part; 12 connecting part; 12A growth interface area; 12B support structure area; 21 base channel; 22 fixing rod fixing channel; 23 base center channel; 25 main accommodating cavity; 26 auxiliary accommodating cavity; 41 column; 45 protrusion; 51 inlet; 52 pressing part; 53 outlet; 54 fluid passage; 121 input hole; 131 confluence sink; 141 positioning locking recess; 6 bone grafting suppressor; 61 handle part; 62 pressure part; 621 bottom arc surface area; 623 limit groove; A first side surface; B second side surface. DETAILED DESCRIPTION

[0046] 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.

[0047] Figure 1-2 The bracket assembly state is shown. The bracket comprises: a bracket shell 1 and a base 2.

[0048] A stent is a support implant that may be provided for insertion into a surgical site, such as a hole in a bone, and in the specific example herein, into the femoral head.

[0049] It should be noted that after the implant is implanted in the human body, the inner side is called the head end and the outer side is called the tail end.

[0050] The bracket shell 1 includes a porous part 11 in the middle and a tail connecting part 12. The porous part 11 can be a porous material with interconnected gaps made by 3D metal printing. The tail end of the porous part 11 is provided with a connecting part 12, which is made of solid material and has internal or external threads.

[0051] The bracket further includes a base 2, which is made of solid material and has a thread at its head end. The connecting portion 12 is connected to the head end of the base 2 by thread.

[0052] like Figure 1 As shown, the outer surface of the base 2 may be additionally provided with threads or a rough surface to increase the friction between the base 2 and the bone during implantation, thereby facilitating a stronger attachment of the stent body to the bone.

[0053] 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.

[0054] An opening is formed at the head end of the support shell 1 , and internal fillers can be placed into the support shell 1 through the opening.

[0055] The stent housing 1 is cup-shaped and forms a longitudinally extending inner cavity. The porous portion 11 has a cylindrical outer wall surface and a substantially elliptical inner wall surface, the elliptical inner wall surface defines an inner cavity, and is made of a porous material.

[0056] like Figure 5 As shown, the cross-sectional shape of the inner cavity is elliptical.

[0057] Due to the use of an elliptical cylindrical inner cavity, the wall of the porous portion 11 has a variable wall thickness area, and the area corresponding to the long axis direction of the elliptical cylindrical inner cavity has a thinner thickness. The thinner thickness can provide a good communication channel between the inside and outside of the porous portion 11, and this area serves as the growth interface area 12A of the porous portion.

[0058] The area corresponding to the short axis direction of the elliptical cylindrical inner cavity has a thicker thickness, which provides good axial and radial support strength for the porous portion 11 . This area serves as the supporting structure area 12B of the porous portion 11 .

[0059] The relative elasticity of the porous material enables the support shell 1 to produce a small deformation. Since the growth interface region has a relatively thin thickness, it can also serve as an easy deformation region of the porous part.

[0060] To facilitate radial expansion, the walls of the thinner growth interface region should not be too thick.

[0061] like Figure 5As shown, the porous portion 11 has two relatively arranged growth interface areas and two supporting structure areas. The supporting structure areas are used to provide structural strength to the porous portion, and the growth interface areas are used to provide internal and external interconnection and radial expansion of the porous portion. The porous portion has a composite structure and multiple functions.

[0062] The inner cavity 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;

[0063] Autologous bone can be selected from bone tissue material drilled during the main surgery. By backfilling, intraoperative loss can be avoided and the use of autologous bone can help bone repair.

[0064] Artificial bone induction materials can be selected from one or more of artificial bone synthesized by "collagen + sodium alginate + nano-hydroxyapatite", artificial bone synthesized by "collagen + nano-hydroxyapatite", hydroxyapatite (HA), tricalcium phosphate (TCP), and bidirectional calcium phosphate (BCP).

[0065] As the bioactive material, for example, platelet-rich plasma (PRP) or the like is used.

[0066] The filler can be in granular form and is filled into the inner cavity of the stent by an instrument. The instrument is operated to apply a pressing force to compact the filler.

[0067] The filler can also be processed into a colloid state, injected into the inner cavity through a syringe, and then solidified.

[0068] After the filler is compressed or solidified in the inner cavity, it forms sufficient mechanical strength and the growth interface area has strong elasticity. Under the action of the elastic force generated by the slight deformation, the stent shell 1 can be ensured to tightly wrap and pressurize the internal filler, thereby forming a complete implant through the covering effect of the stent shell 1.

[0069] like Figure 1-6 As shown, the stent also has a crown end 3. The crown end 3 is used to install and cover the head end opening of the stent shell 1 to form a complete outer contour of the stent shell 1.

[0070] The coronal end 3 is located at the very end of the stent. When implanted into the bone, the coronal end 3 will first contact the bone tissue and be subjected to the human body pressure from the bone tissue. It provides the required internal support for the patient's surgical site and accelerates the recovery and growth of bone tissue through peripheral microcirculation reconstruction.

[0071] The crown end portion 3 is in the shape of a part of a sphere, and the circular edge at the bottom thereof matches the opening at the head end of the stent housing 1 and has the same diameter size.

[0072] The inner side of the coronal end 3 is an arc-shaped bottom surface, and the curvature of the arc-shaped bottom surface is adapted to the curvature of the outer surface of the coronal end 3, so that the spherical coronal end 3 has the same wall thickness dimension, and the internal filler can have the same inner and outer side passages between the outer surface of the coronal end 3, and the internal filler is easy to transfer substances with the bone tissue around the head end of the bracket shell 1.

[0073] Filling material is filled in the inner cavity of the stent; the filling material can be pre-compacted and pre-cured by using an instrument;

[0074] like Fig.16 , 17 As shown, a bone grafting presser 6 used in conjunction with the stent is also included. The bone grafting presser 6 can be used to compress the filling material in the inner cavity of the stent.

[0075] The bone grafting impactor 6 comprises a handle portion 61 and a pressure applying portion 62 , and one end of the handle portion 61 is fixedly connected to the pressure applying portion 62 .

[0076] The handle portion 61 is in the shape of an elongated strip and is used for the operator to grasp and apply force.

[0077] The pressure-applying portion 62 is a cylinder, and its bottom surface forms a structure for press-fitting with the head end of the stent housing 1. A bottom arc surface area 621 is formed at the center of the bottom surface, and the bottom arc surface area 621 has the same arc bottom surface as the inner side of the coronal end 3. When the pressure-applying portion 62 is matched with the head end of the stent housing 1, the bottom arc surface area 621 can compress the filling material in the stent inner cavity and form a top arc surface of the filling material, and the top arc surface of the filling material can form a complete match with the inner arc bottom surface of the coronal end 3.

[0078] The outer periphery of the bottom arc surface area 621 is also processed with a limiting groove 623, which is a circular groove that matches the opening at the head end of the bracket housing 1. Fig.18 As shown, when the pressure-applying portion 62 is matched with the head end of the bracket shell 1, the opening edge of the head end of the bracket shell 1 can be inserted into the limiting groove 623 for positioning, and at this time, the bottom arc surface area 621 also extends into the filling material in the bracket cavity to compress it.

[0079] The coronal end 3 adopts a porous structure, which can be a porous structure with interconnected pores made by 3D printing. In addition, the coronal end can also adopt artificial bone induction materials, which can be selected from one or more of artificial bone synthesized by "collagen + sodium alginate + nano-hydroxyapatite", artificial bone synthesized by "collagen + nano-hydroxyapatite", hydroxyapatite (HA), tricalcium phosphate (TCP), and bidirectional calcium phosphate (BCP).

[0080] When the coronal end 3 adopts a porous structure, since the outer surface of the porous structure has pores, the coronal end 3 is used to support and receive the human body pressure from the bone tissue. In order to provide additional initial mechanical strength and stability to the porous structure of the coronal end 3, the porous structure of the coronal end 3 can be infiltrated with a filling material, and the filling material adopts a degradable and absorbable metal material, bioceramic or polymer material. Examples of degradable and absorbable polymers may include polylactic acid (PLA), polyglycolic acid (PGA), polylactic acid-co-glycolic acid (PLGA), polyhydroxybutyrate (PHB), polyhydroxyvalerate (PHV) and its copolymers, polycaprolactone, polyanhydride and polyorthoester. The degradable and absorbable material filled in the porous structure of the coronal end 3 can ensure the uniformity of the force on the structure and surface of the coronal end 3 at the initial stage of implantation, better receive and transmit the human body pressure from the bone tissue, and the filling material can be absorbed and replaced as the new bone grows, so as to maintain the strength and stability of the implanted structure of the coronal end. Various degradable materials can be degraded and absorbed after being implanted in the body, and will not hinder the growth of bone tissue and vascular tissue into the coronal end 3.

[0081] When the coronal end 3 is made of artificial bone induction material, a plurality of micropores are processed on the coronal end to form an inner and outer passage between the end accommodating cavity and the outer surface of the crown cap, which is beneficial to the reconstruction of microcirculation near the coronal end.

[0082] like Figure 7 , 8 As shown in 14-15, the bracket is assembled by using the thread of the connecting portion 12 at the rear end of the bracket shell to cooperate with the thread of the base.

[0083] The connecting portion 12 is processed to form an internal thread, and the base head is processed to form an external thread, which cooperates with each other to achieve connection. In addition, the internal thread of the connecting portion 12 and the external thread of the base head adopt tapered threads, which can achieve a more stable connection.

[0084] Furthermore, a one-way fluid control element 5 and a positioning locking element 4 are provided at the connection between the bracket shell and the base.

[0085] like Figure 7 , 8 As shown in 15, the connecting portion 12 has a disc body, a first side surface A of the disc body is connected to the porous portion 11, serving as the bottom of the inner cavity of the bracket shell, and a second side surface B extends out of the cylindrical outer wall and is connected to the base 2 through an internal thread, and cooperates with the head end surface of the base 2.

[0086] The connecting portion 12 has a plurality of input holes 121 arranged axially, and the input holes 121 penetrate the first side surface A and the second side surface B.

[0087] The plurality of input holes 121 include peripheral holes and a central hole, and both the peripheral holes and the central hole are through holes. The input holes 121 serve as fluid passages.

[0088] The filler in the inner cavity of the stent shell 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, it is impossible to absorb and excrete the waste gas and waste liquid from the human body. 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. The input hole 121 can be used to lead out the waste gas and waste liquid in the inner cavity.

[0089] A confluence trough 131 is formed on the second side surface B. The structural shape of the confluence trough corresponds to the plurality of input holes 121. The input holes 121 are connected, that is, the exhausted waste gas and waste liquid can be converged in the confluence trough and output.

[0090] Preferably, the four edge holes are arranged in a cross shape, with the central hole at the center of the circle. The corresponding confluence sink also adopts a cross structure.

[0091] The second side surface B is also processed to form positioning locking recessed holes 141. The positioning locking recessed holes are a plurality of recessed holes formed on the second side surface B, which are in the shape of a hemisphere. The positioning locking recessed holes will cooperate with the positioning locking elements on the base to position and lock the bracket housing when the bracket housing and the base are threadedly connected.

[0092] The positioning and locking recessed holes have four recessed holes, which are also arranged in a cross shape and are staggered with the positions of the confluence sinks so as not to affect each other.

[0093] Furthermore, if Fig.12 , 13 As shown,

[0094] The base 2 has an external thread formed at the head end, which cooperates with the internal thread of the connecting portion 12 .

[0095] The head end of the base 2 is also formed with a main accommodating cavity 25 , which is used to place the one-way fluid control element 5 .

[0096] The accommodating cavity 25 opens at the head end surface of the base 2 , is located at the center of the base 2 , and has a certain depth.

[0097] The cross section of the accommodating cavity 25 can adopt any geometric shape.

[0098] Usually, the cross section of the accommodating cavity is approximately a rectangular outline, and the accommodating cavity 25 forms an approximately six-sided cube structure for accommodating the corresponding one-way fluid control element 5 .

[0099] A central channel 23 is also provided at the center of the base 2 . The central channel 23 passes through the base 2 , with one end opening at the bottom of the main accommodating cavity 25 and the other end opening at the bottom end surface of the base 2 .

[0100] The base 2 is also provided with several auxiliary accommodating cavities 26 around the head end thereof, and the auxiliary accommodating cavities 26 are used to place the positioning and locking elements 4. In cooperation with the positioning and locking recessed holes of the connecting portion 12, preferably, four auxiliary accommodating cavities can be used and arranged in a cross.

[0101] The positioning locking element 4 includes a column 41, which has an internal elastic body and a hemispherical protrusion 45 on the head. Under the action of external pressure, the hemispherical protrusion 45 will compress the internal elastic body. The positioning locking element 4 is placed in the auxiliary accommodation cavity 26. When the bracket shell is threadedly connected to the base, the hemispherical protrusion 45 will be pressed by the second side surface B during the rotation and tightening process. When the bracket shell is rotated to a predetermined position, the hemispherical protrusion 45 pops out and enters the concave hole on the second side surface B to form a positioning and tightening effect, and the threaded connection between the bracket shell and the base is positioned and tightened.

[0102] The auxiliary accommodating chamber 26 can be processed on the accommodating chamber 25, that is, the auxiliary accommodating chamber and the main accommodating chamber partially overlap in axial projection. Through the overlap of the spatial structures of the two, the positioning and locking element 4 in the auxiliary accommodating chamber 26 can apply a pressing force to the one-way fluid control element 5 in the main accommodating chamber, so that the rear end surface of the one-way fluid control element 5 and the bottom surface of the main accommodating chamber are in close contact, ensuring the sealing effect of the contact surface.

[0103] Two of the four auxiliary accommodating cavities 26 may partially overlap with the main accommodating cavity in axial projection.

[0104] Similarly, a pressing portion 52 is formed at the head end of the one-way fluid control element 5 , and the positioning locking element 4 is in contact with and fits with the pressing portion 52 .

[0105] The one-way fluid control element 5 can be approximately a six-sided cubic structure, in the shape of a flat plate, with an inlet 51 and an outlet 53 at both ends, and a fluid passage 54 processed inside, and the fluid passage 54 adopts a Tesla valve type.

[0106] The head end of the one-way fluid control element 5 is processed into a shoulder structure to form a pressing portion 52 .

[0107] The two ends of the one-way fluid control element 5 are provided with an inlet 51 and an outlet 53 connected to an internal fluid passage 54 .

[0108] When the one-way fluid control element 5 is placed in the main accommodating cavity 25 of the base, its internal fluid passage 54 is connected to the central channel 23 of the base 2 through the outlet 53. Further, when the bracket shell is connected to the base 2, the converging sink 131 of the bracket shell connection part is also connected to its internal fluid passage 54 through the inlet 51, thereby forming a complete channel for leading waste gas and waste liquid from the inner cavity of the bracket shell. The one-way fluid control element 5 controls the one-way flow in the channel.

[0109] In order to place the implant in the hole in the bone, the components are initially separated from one another.

[0110] First, design the corresponding stent lumen filling plan according to the individual patient.

[0111] The one-way fluid control element 5 and the positioning locking element 4 are placed in the accommodating cavity of the base, and the bracket shell is threadedly connected to the base.

[0112] Preferably, the one-way fluid control element 5 is placed first, and then the positioning and locking element 4 is placed to press the one-way fluid control element 5 .

[0113] During the operation, the femoral head core is drilled and the corresponding autologous bone particles are collected; healthy autologous bone, allogeneic bone, artificial bone, bioactive materials, etc. are selected as filling materials.

[0114] Perform filling operation with filling material in the inner cavity; perform pre-compacting and pre-curing operation of the filling material using an instrument (such as a bone grafting presser);

[0115] The selected coronal end 3 is buckled and assembled into an integral implant under the elastic covering effect of the stent shell 1. After assembly, the stent can be implanted into the cavity formed after the decompression lesion of the femoral head ischemic necrosis is removed, playing the role of biomechanical support and promoting the growth of blood vessels and bone tissue.

[0116] The whole implant is inserted into the drilled hole on the bone tissue, and the doctor uses the osteotome to engage the base 2 to generate longitudinal force, and presses or screws or knocks the assembled implant into the hole. The outer surface of the base 2 can be provided with a thread or a rough surface, and the base is tightly fixed to the surrounding tissue by rotation or extrusion.

[0117] The coronal end 3 and the porous member of the stent shell 1 are pressed against the surrounding bone forming the hole, and the coronal end 3 and the stent shell 1 are used to generate initial stability in multiple directions.

[0118] 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, and provide the necessary stem cells, oxygen, nutrients, growth factors for the new bone tissue and remove local metabolic waste.

[0119] 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.

[0120] 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 filler bone implant for promoting pressure release, comprising a support shell and a base, characterized in that: The inner cavity of the bracket shell is filled with filling material; the bracket shell and the base are detachably connected, and a one-way fluid control element is provided at the connection between the two; the inlet of the one-way fluid control element is connected to the inner cavity, and the outlet of the one-way fluid control element is connected to the external environment or instruments and equipment.

2. The filler-type bone implant for promoting pressure release according to claim 1, characterized in that: An opening is formed at the head end of the support shell, and the filling material is placed into the inner cavity through the opening; the filling material is compacted by a press.

3. The filler-type bone implant for promoting pressure release according to claim 2, characterized in that: The opening is snapped shut with a crown end.

4. The filler-type bone implant for promoting pressure release according to claim 1, characterized in that: A fluid through hole is formed on the bottom of the inner cavity of the bracket shell, the inlet of the fluid through hole is connected to the inner cavity, and the outlet thereof is connected to the inlet of the one-way fluid control element.

5. The filler-type bone implant for promoting pressure release according to claim 1, characterized in that: The one-way fluid control element is detachably placed in the main accommodating cavity in the base, and its outlet is connected with the passage in the base to form an external outlet.

6. The filler-type bone implant for promoting pressure release according to claim 4, characterized in that: There are a plurality of fluid through holes, and a confluence sink is formed on the outer side of the bottom of the inner cavity. The plurality of fluid through holes are connected through the confluence sink and further connected to the inlet of the one-way fluid control element.

7. The filler-type bone implant for promoting pressure release according to claim 5, characterized in that: A positioning locking assembly is also provided at the connection between the bracket shell and the base.

8. The filler-type bone implant for promoting pressure release according to claim 1, characterized in that: The positioning locking assembly includes a positioning recess and a positioning column; the positioning recess is formed on the bottom end surface of the inner cavity of the bracket shell, and the positioning column is located in the auxiliary accommodating cavity in the base; the positioning column has an internal elastic body and a head protrusion, and its head protrusion is pressed into the positioning recess.

9. The filler-type bone implant for promoting pressure release according to claim 1, characterized in that: The auxiliary accommodating chamber is arranged to partially overlap with the main accommodating chamber, and the positioning column in the auxiliary accommodating chamber applies a pressing force to the one-way fluid control element in the main accommodating chamber.

10. The filler-type bone implant for promoting pressure release according to claim 1, characterized in that: A fluid passage is processed inside the one-way fluid control element, and the fluid passage adopts a Tesla valve type.

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