Femoral stem

Abstract

The present invention provides a femoral stem, comprising: a stem body, on which a mounting portion is provided; a drug container, which is fixedly mounted on the mounting portion, the drug container having a holding cavity for holding drugs, and the drug container is provided with flow holes and sustained-release holes that are connected to the holding cavity at intervals; wherein a drug control cavity with a variable volume is provided in the stem body, the flow hole is connected to the drug control cavity, and the sustained-release hole is connected to the outside of the stem body, wherein the drug control cavity includes a plurality of cavity segments that are connected in sequence, and each cavity segment has a different volume. The technical solution of the present application effectively solves the problem of loosening of artificial hip joint prostheses due to long-term bone nonunion in the related art, and the drug in the holding cavity can be one of anti-infective drugs, osteopromoting drugs, anti-osteoporosis drugs and anti-tumor drugs, and doctors can choose according to the actual situation of the patient, so that the femoral stem can also provide assistance for the corresponding treatment.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a femoral stem. Background Art

[0002] Artificial hip replacement is the most commonly used surgical method to effectively treat severe hip diseases such as hip osteoarthritis, femoral neck fracture, and femoral head necrosis. Hip replacement using femoral stems has a history of nearly a hundred years. However, some patients experience complications such as prosthesis loosening, dislocation, infection, and periprosthetic fracture at different times after surgery. Improving the interface bonding ability between artificial hip prostheses and host bone tissue is an important factor in improving the early and long-term stability of artificial hip implants.

[0003] At present, artificial hip prostheses are often treated with surface treatment to form a microporous rough surface, improve the induction and ingrowth ability of bone cells, and improve the loosening problem of artificial hip prostheses. For example, titanium wire sintering, plasma spraying of titanium alloy powder, hydroxyapatite coating, etc. are performed on the surface of artificial hip prostheses. However, the bonding force between the coating and the substrate is relatively insufficient, which easily causes the coating to fall off. At the same time, the coating is easy to wear and produce debris, which leads to aseptic loosening and immune rejection. However, according to current statistics, the infection rate after daily open surgery reaches 3 to 29%. Therefore, the infection of artificial hip prostheses after joint replacement has not been well solved.

[0004] Patients with femoral head or femoral neck fractures are generally elderly patients, who also commonly suffer from other diseases such as osteoporosis. After joint replacement, infection may lead to long bone healing time or even non-union. At present, in clinical practice, non-union may occur due to poor blood flow around the fracture. Due to long-term non-union, the artificial hip prosthesis may become loose. Summary of the invention

[0005] The main purpose of the present invention is to provide a femoral stem to solve the problem of loosening of artificial hip prosthesis due to long-term bone nonunion in the related art, and the drug in the accommodating cavity can be one of anti-infective drugs, osteopromoting drugs, anti-osteoporosis drugs and anti-tumor drugs. Doctors can choose according to the actual situation of the patient, so that the femoral stem can also provide assistance for the corresponding treatment.

[0006] In order to achieve the above-mentioned purpose, the present invention provides a femoral stem, comprising: a stem body, on which a mounting portion is arranged; a drug-containing container, which is fixedly mounted on the mounting portion, the drug-containing container having a containing cavity for containing drugs, and the drug-containing container is provided with flow holes and sustained-release holes connected to the containing cavity at intervals; wherein a drug-control cavity with a variable volume is arranged in the stem body, the flow holes are connected to the drug-control cavity, and the sustained-release holes are connected to the outside of the stem body, wherein the drug-control cavity includes a plurality of cavity segments which are connected in sequence, and the volume of each cavity segment is different.

[0007] Furthermore, each cavity segment includes a first arc surface and a second arc surface facing opposite to the opening of the first arc surface, and when the handle body is subjected to force, the distance between the first arc surface and the second arc surface gradually decreases.

[0008] Furthermore, one side of the first curved surface closest to the center line of the handle body among the multiple cavity segments is connected to one side of the second curved surface, an open opening is formed between one side of the first curved surface farthest from the center line of the handle body and one side of the second curved surface, and the flow hole is located at the open opening; there are three cavity segments between the outside of the handle body and the center line of the handle body, and the cavity segment located in the middle of the three cavity segments has the smallest volume, and the curvature of the first curved surface of the cavity segment located in the middle is the largest.

[0009] Further, the mounting portion is a mounting cavity, the drug-carrying container is a first drug-carrying ellipsoid, and the first drug-carrying ellipsoid is interference-connected to the mounting cavity.

[0010] Furthermore, there are a plurality of sustained-release holes, and the plurality of sustained-release holes are arranged at intervals on the first drug-loaded ellipsoid.

[0011] Furthermore, the mounting portion is a spherical segment-shaped cavity, the drug-carrying container is a second drug-carrying ellipsoid, and the second drug-carrying ellipsoid is interference-connected to the spherical segment-shaped cavity.

[0012] Furthermore, there is one flow hole and one sustained-release hole.

[0013] Furthermore, the mounting portion is a cylindrical cavity, the drug-carrying container is a drug-carrying tube, the drug-carrying tube is interference-connected to the cylindrical cavity, the flow hole is located at the first end of the cylindrical cavity, and the sustained-release hole is located at the second end of the cylindrical cavity.

[0014] Furthermore, the drug-carrying tube is a polyhedral structure.

[0015] Furthermore, the diameter of the flow hole and / or the diameter of the sustained-release hole is in the range of 100 microns to 800 microns; when the drug-loaded container is a drug-loaded ellipsoid, the outer diameter of the short axis of the drug-loaded ellipsoid is in the range of 0.5 mm to 3 mm, and the inner diameter of the short axis of the drug-loaded ellipsoid is in the range of 0.3 mm to 2.5 mm; when the drug-loaded container is a drug-loaded tube, the inner diameter of the drug-loaded tube is in the range of 0.05 mm to 0.5 mm, and the height of the drug-loaded tube is in the range of 1 mm to 3 mm; the outer surface of the handle and the outer surface of the drug-loaded container are both covered with an anti-overflow layer.

[0016] Furthermore, there are multiple mounting parts, which are arranged in multiple layers around the handle body at intervals, there are multiple drug containers, which are arranged one-to-one correspondingly to the multiple mounting parts, there are multiple drug control cavities, and multiple drug containers located on the same layer among the multiple drug containers are arranged correspondingly to one drug control cavity, or multiple drug containers located on the same layer among the multiple drug containers are arranged one-to-one correspondingly to multiple drug control cavities.

[0017] Furthermore, when multiple drug-carrying containers located on the same layer among multiple drug-carrying containers are arranged corresponding to a drug control cavity, the number of cavity segments of each drug control cavity includes two, the first cavity segment includes a first annular arc surface and a second annular arc surface opposite to the opening of the first annular arc surface, an annular opening is formed between the first annular arc surface and the second annular arc surface, and the flow holes of the drug-carrying containers located on the same layer among the multiple drug-carrying containers are located at the annular opening; the second cavity segment includes a first plane and a second plane spaced apart from each other, the first plane is connected to the inner side of the first annular arc surface, and the second plane is connected to the inner side of the second annular arc surface.

[0018] Applying the technical solution of the present invention, the femoral stem includes: a stem body and a drug container. A mounting portion is provided on the stem body. The drug container is fixedly mounted on the mounting portion, and the drug container has a containing cavity for containing drugs, and the drug container is provided with flow holes and sustained-release holes that are connected to the containing cavity at intervals. In this way, the containing cavity of the drug container is loaded with drugs separately, which is convenient for calculation, so as to control the total amount of drugs loaded, and it is also convenient to design the size of the drug container to adapt to stem bodies of different shapes and sizes. In the present application, a drug control cavity with a variable volume is provided in the stem body, the flow hole is connected to the drug control cavity, and the sustained-release hole is connected to the outside of the stem body, wherein the drug control cavity includes a plurality of cavity segments that are connected in sequence, and the volume of each cavity segment is different. The femoral stem can be implanted around the fracture of the human body, and the containing cavity of the drug container is loaded with drugs, and the drugs act on the fracture through the sustained-release holes, so that the blood circulation around the fracture is good and the bone healing time is shortened. This reduces the possibility of loosening of the artificial hip prosthesis, and helps the efficacy of open wounds according to the type of medicine contained in the medicine container. Therefore, the technical solution of the present application can solve the problem of loosening of the artificial hip prosthesis due to long-term bone nonunion in the related art. In addition, during the bone healing process, when the handle is bent under force, the drug control cavity is compressed, and the volume of the drug control cavity changes from large to small. The medium in the drug control cavity overflows into the containing cavity through the flow hole to push the drug, accelerating the release of the drug from the sustained-release hole. When the fracture is not healed or the patient is more active, the amount of drug released is greater, which greatly improves the blood circulation environment around the fracture, can effectively shorten the bone healing time, and thus greatly reduces the possibility of loosening of the artificial hip prosthesis. Moreover, when the fracture has not healed or the patient is more active, since the drug control cavity includes a plurality of cavity segments connected in sequence, each cavity segment has a different volume, so the speed at which the control medium overflows into the containing cavity through the flow hole is different. In this way, the release amount of the accelerated drug from the sustained-release hole can be reasonably controlled according to the fracture has not healed or the patient's activity, thereby effectively improving the blood circulation environment around the fracture. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The drawings constituting a part of the present application are used to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention. In the drawings:

[0020] Figure 1 A schematic diagram of the stereoscopic structure of a femoral stem according to an embodiment of the present invention implanted around a femoral neck fracture is shown;

[0021] Figure 2 Shows Figure 1 A schematic diagram of the three-dimensional structure of a femoral stem with a drug-carrying container;

[0022] Figure 3 Shows Figure 1A schematic cross-sectional view of a femoral stem having a stem body with a first drug-loaded ellipsoid;

[0023] Figure 4 Shows Figure 1 A schematic cross-sectional view of a femoral stem having a second drug-loaded ellipsoid;

[0024] Figure 5 Shows Figure 1 A schematic cross-sectional view of a femoral stem with a drug-carrying tube;

[0025] Figure 6 Shows Figure 3 A schematic diagram of the three-dimensional structure of the first drug-loaded ellipsoid of the femoral stem;

[0026] Figure 7 Shows Figure 4 Schematic diagram of the three-dimensional structure of the second drug-loaded ellipsoid of the femoral stem;

[0027] Figure 8 Shows Figure 5 A schematic diagram of the three-dimensional structure of the drug-carrying tube of the femoral stem;

[0028] Fig. 9 Shows Figure 4 A partial schematic diagram of the femoral stem with the second drug-loaded ellipsoid when the stem body is not subjected to force;

[0029] Fig.10 Shows Figure 4 A partial schematic diagram of a femoral stem with a second drug-loaded ellipsoid when the stem is subjected to force;

[0030] Fig.11 Shows Fig. 9 A partial schematic diagram of the femoral stem with the second drug-loaded ellipsoid when the stem body is not subjected to force;

[0031] Fig.12 Shows Fig.10 A partial schematic diagram of a femoral stem with a second drug-loaded ellipsoid when the stem is subjected to force;

[0032] Fig.13 Shows Figure 1 A schematic diagram of a three-dimensional structure of a femoral stem having a drug-carrying container on the entire stem body;

[0033] Fig.14 A schematic three-dimensional structure diagram of an embodiment of a negative pressure drug loading device according to the present invention is shown.

[0034] The above drawings include the following reference numerals:

[0035] 2. Femur; 102. Handle body; 11. Drug control cavity; 111. First arc surface; 112. Second arc surface; 113. First annular arc surface; 114. Second annular arc surface; 20. Drug loading container; 21. First drug loading ellipsoid; 22. Second drug loading ellipsoid; 23. Drug loading tube; 24. Flow hole; 25. Sustained release hole; 30. Vacuum pump; 40. Drug push rod; 51. Box body; 52. Box cover; 60. Drug loading box; 80. Heating tube; F. Force. DETAILED DESCRIPTION

[0036] 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, rather than all the embodiments. The following description of at least one exemplary embodiment is actually only illustrative and is by no means intended to limit the present invention and its application or use. 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.

[0037] It should be noted that the terms used herein are only for describing specific embodiments and are not intended to limit the exemplary embodiments according to the present application. As used herein, unless the context clearly indicates otherwise, the singular form is also intended to include the plural form. In addition, it should be understood that when the terms "comprise" and / or "include" are used in this specification, it indicates the presence of features, steps, operations, devices, components and / or combinations thereof.

[0038] Unless otherwise specifically stated, the relative arrangement of the parts and steps described in these embodiments, numerical expressions and numerical values ​​do not limit the scope of the present invention. At the same time, it should be understood that, for ease of description, the sizes of the various parts shown in the accompanying drawings are not drawn according to the actual proportional relationship. The technology, method and equipment known to ordinary technicians in the relevant field may not be discussed in detail, but in appropriate cases, the technology, method and equipment should be regarded as a part of the authorization specification. In all examples shown and discussed here, any specific value should be interpreted as being merely exemplary, rather than as a limitation. Therefore, other examples of exemplary embodiments may have different values. It should be noted that similar reference numerals and letters represent similar items in the following drawings, so once a certain item is defined in an accompanying drawing, it does not need to be further discussed in subsequent drawings.

[0039] like Figures 1 to 12As shown, the femoral stem of this embodiment includes: a stem body 102 and a drug container 20. A mounting portion is provided on the stem body 102. The drug container 20 is fixedly mounted on the mounting portion, and the drug container 20 has a containing cavity for containing drugs, and flow holes 24 and sustained-release holes 25 connected to the containing cavity are provided at intervals on the drug container 20. A drug control cavity 11 with a variable volume is provided in the stem body 102, the flow hole 24 is connected to the drug control cavity 11, and the sustained-release hole 25 is connected to the outside of the stem body 102, wherein the drug control cavity 11 includes a plurality of cavity segments connected in sequence, and each cavity segment has a different volume.

[0040] The technical solution of this embodiment is applied, and the drug container 20 is fixedly installed on the mounting part. The drug container 20 has a containing cavity for containing drugs, and the drug container 20 is provided with flow holes 24 and sustained-release holes 25 communicating with the containing cavity at intervals. In this way, the containing cavity of the drug container 20 is loaded with drugs separately, which is convenient for calculation, so as to control the total amount of drugs loaded, and it is also convenient to design the size of the drug container 20 to adapt to the handle body 102 of different shapes and sizes. In this embodiment, a drug control cavity 11 with a variable volume is provided in the handle body 102, the flow hole 24 is connected to the drug control cavity 11, and the sustained-release hole 25 is connected to the outside of the handle body 102, wherein the drug control cavity 11 includes a plurality of cavity segments connected in sequence, and the volume of each cavity segment is different. The femoral stem can be implanted around the fracture of the human body, and the containing cavity of the drug container 20 is loaded with drugs, and the drugs act on the fracture through the sustained-release hole 25, so that the blood circulation around the fracture is good and the bone healing time is shortened. Thus, the possibility of loosening of the artificial hip joint prosthesis is reduced, and according to the type of medicine contained in the medicine container, the efficacy of open wounds is helped. Therefore, the technical solution of this embodiment can solve the problem of loosening of the artificial hip joint prosthesis due to long-term bone non-union in the related art. In addition, during the bone healing process, when the handle body 102 is bent by force F, the drug control cavity 11 is compressed, and the volume of the drug control cavity 11 changes from large to small. The medium in the drug control cavity 11 overflows into the containing cavity through the flow hole 24 to push the drug, and accelerates the release of the drug from the sustained-release hole 25. When the fracture is not healed or the patient is more active, the drug release amount is greater, which greatly improves the blood supply environment around the fracture, can effectively shorten the bone healing time, and thus greatly reduces the possibility of loosening of the artificial hip joint prosthesis. In this way, the patient does not need to undergo a secondary revision surgery, which can reduce secondary injuries and eliminate the generation of a large amount of clinical expenses. Furthermore, when the fracture has not healed or the patient is more active, since the drug control cavity 11 includes a plurality of cavity segments connected in sequence, each cavity segment has a different volume, so that the speed at which the control medium overflows into the accommodating cavity through the flow hole 24 is different. In this way, the release amount of the accelerated drug from the sustained-release hole 25 can be reasonably controlled according to the fracture has not healed or the patient's activity, thereby effectively improving the blood circulation environment around the fracture.

[0041] It should be noted that the above-mentioned "variable volume" means that after the handle 102 is subjected to force, as the force gradually increases, the volume of the drug control cavity 11 can change from large to small, and as the force gradually decreases, the volume of the drug control cavity 11 can change from small to large. The above-mentioned "medium in the drug control cavity 11" can be a granular drug, a powdered drug, or a liquid drug, wherein the liquid drug is such as an anti-infective drug, a bone-promoting drug, and a drug for treating osteoporosis. Specifically, it depends on the drug in the drug container 20, that is, the drug in the drug container 20 and the medium in the drug control cavity 11 are the same drug.

[0042] The handle body 102 and the medicine container 20 of this embodiment can be cast or 3D printed. The handle body 102 and the medicine container 20 are a one-time molding structure, that is, they become one part.

[0043] The femoral stem of this embodiment is implanted around the neck fracture of the femur 2, and the drug in the containing cavity of the drug container 20 acts on the fracture through the sustained-release hole 25, so that the blood flow around the fracture is good and the bone healing time is shortened. The above-mentioned handle body 102 is made of medical metal, and the medical metal used includes but is not limited to titanium and titanium alloys, cobalt alloys, stainless steel, tantalum metal, and magnesium alloys. Such metal materials are specified in the ISO-5830 series of international standards, and their biocompatibility has been confirmed by many years of orthopedic implant application practice at home and abroad. The handle body 102 can also be implanted in the tibia, humerus, radius and other parts of the limbs where fractures are prone to occur.

[0044] When a human fracture occurs, the appropriate specification of the handle body 102 is selected according to the fracture location, and the drug container 20 on the handle body 102 is press-fitted into the proximal medullary cavity of the femur 2 according to the anatomical matching position relationship, ensuring that the sustained-release hole 25 of the drug container 20 can directly act on the fracture site of the proximal femur during drug release, thereby achieving the purpose of small dose and high efficiency.

[0045] like Fig. 9 and Fig.12 As shown, each cavity segment includes a first curved surface 111 and a second curved surface 112 facing opposite to the opening of the first curved surface 111. When the handle body 102 is subjected to a force F, the distance between the first curved surface 111 and the second curved surface 112 gradually decreases. The shapes of the first curved surface 111 and the second curved surface 112 ensure that the drug control cavity 11 has a certain supporting force, and the internal structure of the handle body 102 can still be stable when the drug control cavity 11 is deformed by force. It should be noted that the first curved surface 111 and the second curved surface 112 can both be arch bridge shaped or spherical segment shaped.

[0046] like Fig. 9 and Fig.12As shown, when the handle body 102 is bent by force F, the drug control cavity 11 is compressed. Since the side of the first arc surface 111 closest to the center line L of the handle body 102 in the multiple cavity segments is connected to the side of the second arc surface 112, an open opening is formed between the side of the first arc surface 111 farthest from the center line L of the handle body 102 in the multiple cavity segments and the side of the second arc surface 112. The flow hole 24 is located at the open opening, so that the connection between the side of the first arc surface 111 and the side of the second arc surface 112 is closed, and the medium in the drug control cavity 11 can only flow out from the open opening and enter the flow hole 24, so that the drug control cavity 11 can provide a larger thrust to accelerate the release of the drug. When the fracture is not healed or the patient is more active, the amount of drug released in the accommodating cavity is also greater, and vice versa. The amount of drug released in the accommodating cavity is also smaller. In this way, the drug release can be dynamically controlled according to the actual situation of the patient. In order to more accurately control the speed at which the medium overflows into the accommodating cavity through the flow hole 24, there are three cavity segments between the outside of the handle body 102 and the center line L of the handle body 102, and the volume of the cavity segment located in the middle of the three cavity segments is the smallest, and the curvature of the first curved surface 111 of the cavity segment located in the middle is the largest. In addition, the volume of the cavity segment closest to the center line L of the handle body 102 among the three cavity segments is smaller than the volume of the cavity segment farthest from the center line L of the handle body 102 among the three cavity segments, and the curvature of the first curved surface 111 closest to the center line L of the handle body 102 among the three cavity segments is smaller than the curvature of the first curved surface 111 farthest from the center line L of the handle body 102 among the three cavity segments.

[0047] In this embodiment, when the drug-loaded container 20 is a drug-loaded ellipsoid, the outer diameter of the drug-loaded ellipsoid at the short axis is in the range of 0.5 mm to 3 mm, and the inner diameter of the drug-loaded ellipsoid at the short axis is in the range of 0.3 mm to 2.5 mm. When the drug-loaded container 20 is a drug-loaded tube, the inner diameter of the drug-loaded tube is in the range of 0.05 mm to 0.5 mm, and the height of the drug-loaded tube is in the range of 1 mm to 3 mm.

[0048] In this embodiment, the above-mentioned drug is one of an anti-infective drug, a bone-promoting drug, an anti-osteoporosis drug and an anti-tumor drug. The doctor can choose according to the actual situation of the patient, so that the femoral stem can also provide assistance for the corresponding treatment.

[0049] like Figure 3 and Figure 6As shown, the mounting portion is a mounting cavity, and the drug-carrying container 20 is a first drug-carrying ellipsoid 21, and the first drug-carrying ellipsoid 21 is interference-connected to the mounting cavity. In this way, at least half of the first drug-carrying ellipsoid 21 is exposed outside the outer surface of the handle body 102. When the anti-infective drug is loaded into the first drug-carrying ellipsoid 21, the anti-infective drug in the first drug-carrying ellipsoid 21 acts on the fracture through the sustained-release hole 25, which can achieve anti-infection, improve blood circulation around the fracture, and effectively shorten the bone healing time. The above-mentioned anti-infective drugs include but are not limited to gentamicin, vancomycin, meropenem, and voriconazole. The outer diameter of the short axis of the above-mentioned first drug-carrying ellipsoid 21 is in the range of 0.5 mm to 1.5 mm.

[0050] It should be noted that at least half of the first drug loaded ellipsoid 21 is exposed outside the outer surface of the handle body 102 means that only a part of the first drug loaded ellipsoid 21 is located inside the handle body 102 , and most of the first drug loaded ellipsoid 21 extends outside the outer surface of the handle body 102 .

[0051] like Figure 3 and Figure 6 As shown, there are multiple slow-release holes 25, which are arranged at intervals in the first drug-loaded ellipsoid 21. In this way, the multiple slow-release holes 25 make the anti-infection drug in the first drug-loaded ellipsoid 21 release faster, making the entire release cycle shorter, which is conducive to achieving anti-infection effects.

[0052] like Figure 4 and Figure 7 As shown, the mounting portion is a spherical cavity, and the drug-carrying container 20 is a second drug-carrying ellipsoid 22, and the second drug-carrying ellipsoid 22 is interference-connected to the spherical cavity. In this way, at least half of the second drug-carrying ellipsoid 22 is sunk into the outer surface of the handle body 102. When the osteogenic drug is loaded into the accommodating cavity of the second drug-carrying ellipsoid 22, the osteogenic drug in the second drug-carrying ellipsoid 22 acts on the fracture through the sustained-release hole 25, so that the blood supply around the fracture is good, bone integration can be achieved faster, and the bone healing time can be shortened. The above-mentioned osteogenic drugs include but are not limited to bisphosphonates, parathyroid hormone, fluoride, and growth hormone. The outer diameter of the short axis of the above-mentioned second drug-carrying ellipsoid 22 is in the range of 1 mm to 3 mm. When the anti-osteoporosis drug is loaded into the accommodating cavity of the second drug-loaded ellipsoid 22, the anti-osteoporosis drug in the second drug-loaded ellipsoid 22 acts on the osteoporosis through the sustained-release hole 25, so that the blood circulation around the osteoporosis is good, and osteoporosis can be treated quickly. The above-mentioned anti-osteoporosis drugs include but are not limited to teriparatide, salmon calcitonin, raloxifene, and zoledronic acid.

[0053] It should be noted that at least half of the second drug-loaded ellipsoid 22 is sunk into the outer surface of the handle 102 , which means that the second drug-loaded ellipsoid 22 is entirely located in the handle 102 , or a portion of the second drug-loaded ellipsoid 22 extends outward from the outer surface of the handle 102 .

[0054] In this embodiment, there are multiple mounting parts, which are arranged in multiple layers at intervals around the handle body 102, there are multiple drug containers 20, and the multiple drug containers 20 are arranged in a one-to-one correspondence with the multiple mounting parts, and there are multiple drug control cavities 11. When the handle body 102 is bent by the force F, the drug control cavity 11 is compressed, and multiple drug containers 20 located in the same layer among the multiple drug containers 20 are arranged in a one-to-one correspondence with the multiple drug control cavities 11.

[0055] like Figure 4 and Figure 7 As shown, there is one flow hole 24 and one sustained-release hole 25. Thus, one flow hole 24 and one sustained-release hole 25 slow down the release rate of the osteogenic drug in the second drug-loaded ellipsoid 22, making the entire release cycle longer, which is conducive to achieving the osteogenic effect and achieving faster bone integration.

[0056] The diameter of the accommodating cavity of the first drug-loaded ellipsoid 21 and the diameter of the accommodating cavity of the second drug-loaded ellipsoid 22 are both in the range of 0.3 mm to 2.5 mm.

[0057] like Figure 5 and Figure 8 As shown, the mounting portion is a cylindrical cavity, the drug-carrying container 20 is a drug-carrying tube 23, the drug-carrying tube 23 is interference-connected to the cylindrical cavity, the flow hole 24 is located at the first end of the cylindrical cavity, and the sustained-release hole 25 is located at the second end of the cylindrical cavity. In this way, at least half of the drug-carrying tube 23 is sunk into the outer surface of the handle body 102. When the anti-tumor drug is loaded into the accommodating cavity of the drug-carrying tube 23, the drug-carrying tube 23 with a larger accommodating cavity can carry more drug loading. The anti-tumor drug in the drug-carrying tube 23 acts on the tumor through the sustained-release hole 25, so that the blood circulation around the tumor is good and the tumor is treated faster. The above-mentioned anti-tumor drugs include but are not limited to alkylating agents and nitrogen mustards, platinum compounds, mitomycin, dihydrofolate reductase inhibitors, actinomycin D, paclitaxel, and docetaxel.

[0058] It should be noted that at least half of the drug-carrying tube 23 is sunk into the outer surface of the handle 102 , which means that the drug-carrying tube 23 is entirely located in the handle 102 , or a portion of the drug-carrying tube 23 extends outward from the outer surface of the handle 102 .

[0059] like Figure 5 and Figure 8 As shown, the drug-carrying tube 23 is a polyhedral structure. In this way, the cylindrical cavity is also a polyhedral structure. The drug-carrying tube 23 with a polyhedral structure can carry more drug loading, and at the same time, the sustained-release hole 25 is larger to increase the drug loading and release rate of the drug-carrying tube 23, so that the entire release cycle is shorter, which is conducive to achieving anti-tumor effects. The above-mentioned polyhedral structure is preferably honeycomb. The diameter of the inscribed circle of the honeycomb drug-carrying tube 23 is in the range of 0.05mm to 0.5mm, and the height is in the range of 1mm to 3mm.

[0060] like Figure 3 , Figure 4 , Figure 6 as well as Figure 7 As shown, the diameter of the flow hole 24 and the diameter of the sustained-release hole 25 are in the range of 100 microns to 800 microns, so that the sustained-release hole 25 can serve as a drug sustained-release window of the drug-carrying container 20, and slowly release the anti-infective drug or osteogenic drug or osteoporosis treatment drug or anti-tumor drug in the containing cavity of the drug-carrying container 20. In this way, during the operation, the drug contained in the drug-carrying container 20 on the handle body 102 is reasonably adjusted and matched, and different drugs such as anti-infective, osteogenic, osteoporosis treatment or anti-tumor can be selected, so as to realize flexible selection of patients who respond to fracture emergencies.

[0061] like Figures 1 to 5 As shown, when the liquid medicine is loaded into the containing cavity of the medicine container 20, in order to prevent the medicine from overflowing, the outer surface of the handle and the outer surface of the medicine container are covered with an anti-overflow layer. The anti-overflow layer is preferably biogel.

[0062] Of course, in an embodiment not shown in the drawings, the diameter of the flow hole or the diameter of the sustained-release hole may be in the range of 100 micrometers to 800 micrometers.

[0063] The handle body 102 of this embodiment further comprises a locking screw hole and a universal locking hole arranged on the handle body 102 , so that the femoral stem can be designed in accordance with the anatomical shape to achieve stable anatomical fixation.

[0064] like Figures 9 to 12 As shown, there are multiple mounting parts, which are arranged in multiple layers at intervals around the handle body 102, there are multiple drug containers 20, and the multiple drug containers 20 are arranged one-to-one corresponding to the multiple mounting parts, and there are multiple drug control cavities 11. When the handle body 102 is bent by force F, the drug control cavity 11 is compressed, because multiple drug containers 20 located in the same layer among the multiple drug containers 20 are arranged corresponding to one drug control cavity 11. In this way, one drug control cavity 11 can simultaneously control the release amount of drugs in multiple drug containers 20 located in the same layer, and while considering the internal structural stability of the femoral stem, the femoral stem can be equipped with more drug containers 20, thereby increasing the drug loading capacity of the femoral stem and achieving faster fracture healing.

[0065] It should be noted that the above-mentioned “multiple drug-containing containers 20 located at the same layer are correspondingly arranged with one drug control cavity 11” means that multiple drug-containing containers 20 at the same height in the horizontal direction or at a height within an angle of 30 degrees with the horizontal direction are correspondingly arranged with one drug control cavity 11 .

[0066] like Figures 9 to 12As shown, when multiple drug-carrying containers 20 located on the same layer among multiple drug-carrying containers 20 are arranged corresponding to a drug-controlling cavity 11, when the handle body 102 is bent by force F, the drug-controlling cavity 11 is compressed. Since the number of cavity sections of each drug-controlling cavity 11 includes two, the first cavity section includes a first annular arc surface 113 and a second annular arc surface 114 facing opposite to the opening of the first annular arc surface 113, and an annular opening is formed between the first annular arc surface 113 and the second annular arc surface 114. The flow holes 24 of the drug-carrying containers 20 located on the same layer among the multiple drug-carrying containers 20 are located at the annular opening. The medium in the drug-controlling cavity 11 diffuses to the surroundings and can flow out from the annular opening and enter the flow holes 24 on the same layer, so that the drug-controlling cavity 11 can provide a larger thrust to accelerate the release of the drug. When the fracture is not healed or the patient is more active, the amount of drug released in the accommodating cavity is greater, and vice versa, the amount of drug released in the accommodating cavity is smaller. In this way, the drug release can be dynamically controlled according to the actual situation of the patient. In order to accurately and dynamically control the drug release according to the actual situation of the patient, the second cavity segment includes a first plane and a second plane spaced apart from each other, the first plane is connected to the inner side of the first annular arc surface 113, and the second plane is connected to the inner side of the second annular arc surface 114.

[0067] The shapes of the first annular arc surface 113 and the second annular arc surface 114 ensure that the drug control cavity 11 has a certain support force, and can still ensure the internal structure of the handle body 102 is stable when the drug control cavity 11 is deformed by force. It should be noted that the first annular arc surface 113 and the second annular arc surface 114 can be arch bridge shaped or spherical segment shaped.

[0068] like Figure 2 and Fig.13 As shown, a plurality of mounting portions are arranged in multiple layers at intervals around the handle body 102, and a plurality of medicine containers 20 are provided, and the plurality of medicine containers 20 are arranged one-to-one corresponding to the plurality of mounting portions, and the medicine containers 20 can be arranged on the upper half of the handle body 102, or on the entire handle body 102. These two arrangements and other arrangements not shown in the figure can be adjusted according to the conditions of different patients.

[0069] The present application also provides a negative pressure drug loading device, such as Fig.14 As shown, the negative pressure drug loading device is used to load drugs into multiple drug loading containers 20 of the femoral stem. The negative pressure drug loading device includes: a box 51, a drug loading box 60, a vacuum pump 30, a drug push rod 40 and a box cover 52. The drug loading box 60 is arranged in the box 51, and the femoral stem can be removed and placed in the drug loading box 60, and the top of the drug loading box 60 has an opening. The vacuum pump 30 is connected to the inner cavity of the box 51. The drug push rod 40 is arranged in the box 51 and is connected to the inner cavity of the drug loading box 60. The box cover 52 can be opened and closed at the box opening of the box 51 to form a closed cavity between the box 51, thereby forming a sterile environment.

[0070] The medicine push rod 40 is filled with medicine, and the medicine push rod 40 slowly pushes the medicine into the medicine loading box 60, so that the medicine in the containing cavity of the medicine loading container 20 is loaded with the required medicine at one time under the action of the negative pressure suction of the vacuum pump 30. In this way, different medicines can be loaded according to actual clinical needs. Specifically, the medicine loading is carried out by placing the handle 102 with the medicine loading container 20 in the medicine loading box 60 through the vacuum pump 30, and the vacuum is evacuated to 1×10 -1 KPa, the valve of the drug push rod 40 is opened to suck the drug into the drug loading box 60. The negative pressure drug loading device can be placed in the operating room for real-time operation, and the first drug loading ellipsoid 21, the second drug loading ellipsoid 22 or the drug loading tube 23 can be selected according to actual clinical needs to load the corresponding type of drug. After the negative pressure drug loading is completed, the biogel needs to be applied on the outer surface of the handle body 102 with the drug loading container 20 to prevent the drug in the drug loading container 20 from overflowing.

[0071] like Fig.14 As shown, in order to perform high-temperature and high-pressure disinfection in the closed cavity, the negative pressure drug loading device also includes a heating tube 80 arranged in the box body 51. When the vacuum pump 30 is not working, the temperature in the closed cavity can reach a range of 118°C to 124°C, and the pressure can reach a range of 103KPa to 115KPa, so that the handle body 102 with the drug loading container 20 can carry out efficient drug loading in a sterile environment.

[0072] In the description of the present invention, it is necessary to understand that the directions or positional relationships indicated by directional words such as "front, back, up, down, left, right", "lateral, vertical, perpendicular, horizontal" and "top, bottom" are usually based on the directions or positional relationships shown in the drawings. They are only for the convenience of describing the present invention and simplifying the description. Unless otherwise specified, these directional words do not indicate or imply that the devices or elements referred to must have a specific direction or be constructed and operated in a specific direction. Therefore, they cannot be understood as limiting the scope of protection of the present invention. The directional words "inside and outside" refer to the inside and outside relative to the contours of each component itself.

[0073] For ease of description, spatially relative terms such as "above", "above", "on the upper surface of", "above", etc. may be used here to describe the spatial positional relationship between a device or feature and other devices or features as shown in the figure. It should be understood that spatially relative terms are intended to include different orientations of the device in use or operation in addition to the orientation described in the figure. For example, if the device in the accompanying drawings is inverted, the device described as "above other devices or structures" or "above other devices or structures" will be positioned as "below other devices or structures" or "below other devices or structures". Thus, the exemplary term "above" can include both "above" and "below". The device can also be positioned in other different ways (rotated 90 degrees or in other orientations), and the spatially relative descriptions used here are interpreted accordingly.

[0074] In addition, it should be noted that the use of terms such as "first" and "second" to limit components is only for the convenience of distinguishing the corresponding components. If not otherwise stated, the above terms have no special meaning and therefore cannot be understood as limiting the scope of protection of the present invention.

[0075] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. 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 femoral stem, characterized in that: include: A handle body (102), wherein a mounting portion is provided on the handle body (102); A medicine container (20) is fixedly mounted on the mounting portion, the medicine container (20) having a containing cavity for containing medicine, and the medicine container (20) is provided with flow holes (24) and sustained-release holes (25) communicating with the containing cavity at intervals; A drug control cavity (11) with a variable volume is provided in the handle body (102), the flow hole (24) is in communication with the drug control cavity (11), and the sustained-release hole (25) is in communication with the outside of the handle body (102), wherein the drug control cavity (11) comprises cavity segments that are arranged in sequence and in communication, and each cavity segment has a different volume; Each of the cavity segments comprises a first curved surface (111) and a second curved surface (112) facing opposite to the opening of the first curved surface (111), and when the handle (102) is subjected to force, the distance between the first curved surface (111) and the second curved surface (112) gradually decreases; The side of the first curved surface (111) of the cavity segment closest to the center line (L) of the handle body (102) is connected to the side of the second curved surface (112) of the cavity segment closest to the center line (L) of the handle body (102), and an open opening is formed between the side of the first curved surface (111) of the cavity segment farthest from the center line (L) of the handle body (102) and the side of the second curved surface (112) of the cavity segment farthest from the center line (L) of the handle body (102), and the flow hole (24) is located at the open opening; The number of the cavity segments is three between the outside of the handle body (102) and the center line (L) of the handle body (102), the cavity segment located in the middle of the three cavity segments has the smallest volume, and the curvature of the first curved surface (111) of the cavity segment located in the middle is the largest.

2. The femoral stem according to claim 1, characterized in that: The mounting portion is a mounting cavity, the drug-carrying container (20) is a first drug-carrying ellipsoid (21), and the first drug-carrying ellipsoid (21) is interference-connected to the mounting cavity.

3. The femoral stem according to claim 2, characterized in that: There are a plurality of sustained-release holes (25), and the plurality of sustained-release holes (25) are arranged at intervals on the first drug-loaded ellipsoid (21).

4. The femoral stem according to claim 1, characterized in that: The mounting portion is a spherical segment-shaped cavity, the drug-carrying container (20) is a second drug-carrying ellipsoid (22), and the second drug-carrying ellipsoid (22) is interference-connected to the spherical segment-shaped cavity.

5. The femoral stem according to claim 4, characterized in that: There is one flow-through hole (24) and one sustained-release hole (25).

6. The femoral stem according to claim 1, characterized in that: The mounting portion is a columnar cavity, the drug-carrying container (20) is a drug-carrying tube (23), the drug-carrying tube (23) is interference-connected to the columnar cavity, the flow hole (24) is located at a first end of the columnar cavity, and the slow-release hole (25) is located at a second end of the columnar cavity.

7. The femoral stem according to claim 6, characterized in that: The drug-carrying tube is a polyhedral structure.

8. The femoral stem according to claim 1, characterized in that: The diameter of the flow hole (24) and / or the diameter of the sustained-release hole (25) is in the range of 100 micrometers to 800 micrometers; When the drug-carrying container (20) is a drug-carrying ellipsoid, the outer diameter of the short axis of the drug-carrying ellipsoid is in the range of 0.5 mm to 3 mm, and the inner diameter of the short axis of the drug-carrying ellipsoid is in the range of 0.3 mm to 2.5 mm; when the drug-carrying container (20) is a drug-carrying tube, the inner diameter of the drug-carrying tube is in the range of 0.05 mm to 0.5 mm, and the height of the drug-carrying tube is in the range of 1 mm to 3 mm; The outer surface of the handle body (102) and the outer surface of the medicine container (20) are both covered with an anti-overflow layer.

9. A femoral stem, characterized in that: include: A handle body (102), wherein a mounting portion is provided on the handle body (102); A medicine container (20) is fixedly mounted on the mounting portion, the medicine container (20) having a containing cavity for containing medicine, and the medicine container (20) is provided with flow holes (24) and sustained-release holes (25) communicating with the containing cavity at intervals; A drug control cavity (11) with a variable volume is provided in the handle body (102), the flow hole (24) is in communication with the drug control cavity (11), and the sustained-release hole (25) is in communication with the outside of the handle body (102), wherein the drug control cavity (11) comprises cavity segments that are arranged in sequence and in communication, and each cavity segment has a different volume; There are a plurality of mounting portions, and the plurality of mounting portions are arranged in multiple layers at intervals around the handle body (102); there are a plurality of drug-carrying containers (20), and the plurality of drug-carrying containers (20) are arranged in a one-to-one correspondence with the plurality of mounting portions; there are a plurality of drug-controlling cavities (11), and a plurality of drug-carrying containers (20) located in the same layer among the plurality of drug-carrying containers (20) are arranged in a corresponding manner with one drug-controlling cavity (11); When a plurality of the drug-carrying containers (20) located on the same layer among the plurality of the drug-carrying containers (20) are arranged corresponding to one of the drug-controlling chambers (11), the number of the cavity sections of each of the drug-controlling chambers (11) includes two, the first cavity section includes a first annular arc surface (113) and a second annular arc surface (114) facing opposite to the opening of the first annular arc surface (113), an annular opening is formed between the outer side of the first annular arc surface (113) and the outer side of the second annular arc surface (114), and the flow holes (24) of the drug-carrying containers (20) located on the same layer among the plurality of the drug-carrying containers (20) are located at the annular opening; The second cavity segment comprises a first plane and a second plane which are spaced apart from each other in an upper and lower direction, wherein the first plane is connected to the inner side of the first annular arc surface (113), and the second plane is connected to the inner side of the second annular arc surface (114).

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