CN114027960A

CN114027960A - Orthopedic implant device

Info

Publication number: CN114027960A
Application number: CN202210012777.4A
Authority: CN
Inventors: 丁建忠; 钟振西; 刘建
Original assignee: JIANGSU BAIDE MEDICAL INSTRUMENT CO Ltd
Current assignee: JIANGSU BAIDE MEDICAL INSTRUMENT CO Ltd
Priority date: 2022-01-07
Filing date: 2022-01-07
Publication date: 2022-02-11
Anticipated expiration: 2042-01-07
Also published as: CN114027960B

Abstract

The invention discloses an orthopedic implant device, which comprises an intramedullary nail main body in a core-shell structure, wherein the main body core improves the bending strength by laminating a continuous fiber composite material, and the main body shell improves the torsional strength by the continuous fiber composite material obliquely arranged with the main body core. The expansion cavity is formed in the sealing cap hole of the intramedullary nail main body, the unit is taken out to form the expansion structure, the surface of the expansion structure is attached to or partially attached to the side wall of the expansion cavity, the shearing stress area is increased, namely, the requirement on the shearing strength of the material is correspondingly reduced, and simultaneously, the clamping force is formed between the expansion structure and the side wall of the expansion cavity.

Description

Orthopedic implant device

Technical Field

The invention relates to the technical field of medical instruments, in particular to an orthopedic implant device which is manufactured by using a laminated continuous fiber composite material for an intramedullary nail main body.

Background

In current orthopedic implants, intramedullary nails are generally composed of a combination of an intramedullary nail body, lag screws, and fixation screws. The material is stainless steel and titanium alloy metal with good biocompatibility, and the material generally has high strength and modulus (stress shielding can be caused after implantation), development under X-ray (artifacts can be easily caused on a bone fusion surface), and general fatigue performance (fracture rate of orthopedic implant is generally 9% in clinic). Which may be used to locate and fix fractures of long bones such as the femur in which an intramedullary nail body may be inserted into the intramedullary canal of the femur and placed to extend along the fracture line of the femur, and then inserted through holes formed in the intramedullary nail body on opposite sides of the fractured femur using set screws and/or other fixation devices to secure the opposite sections of the fractured femur together.

However, when the intramedullary nail needs to be taken out of the femur, the nail taking device is needed, at the moment, the fixing screw and the lag screw are taken down, then the sealing cap is taken down, and the nail taking device is installed. For example, chinese patent document CN201624770U discloses an interlocking intramedullary nail extractor leakage-free expansion rod, which comprises an expansion rod, a screw rod, a deformation groove and an annular inclined surface, wherein the screw rod is tubular, the expansion rod is located in the screw rod and is combined with the inner wall of the screw rod through threads, the outer wall of the lower end of the screw rod is provided with three deformation grooves distributed along the circumference of the screw rod, the outer wall of the lower end of the screw rod is provided with threads, the inner wall of the lower end of the screw rod is provided with a ring of annular inclined surface integrated with the screw rod, and the annular inclined surface encloses the inner part of the lower end of the screw rod into a space in the shape of an inverted circular truncated cone. In the process of opening the thread, the end part of the expansion rod does not need to be exposed, so that the end part of the expansion rod is prevented from being exposed, the effective depth of the screw rod inserted into the tail screw hole of the interlocking intramedullary nail is prevented from being shortened due to the exposed end part of the expansion rod, the number of turns of thread combination of the screw rod and the interlocking intramedullary nail is increased, the screwing force between the screw rod and the interlocking intramedullary nail is greatly increased, and the interlocking intramedullary nail is ensured to be taken out smoothly. It can be seen that the extractor is tightly combined with the screw thread at the tail of the nail through the expansion of the end part of the screw rod, the contact between the external screw thread of the screw rod and the screw thread at the tail of the nail is increased, the contact area and the contact force between the screw threads are increased, and therefore the intramedullary nail is smoothly extracted. However, the above-mentioned intramedullary nail extractor is only suitable for intramedullary nails made of metal materials, and for intramedullary nails made of continuous fiber composite materials, especially for intramedullary nails made of continuous fiber composite materials in order to ensure the bending strength, the laminated structure makes the shearing strength of the thread in the nail tail screw hole very low (when the angle between the laying direction of the continuous fiber composite fibers and the axis of the nail tail screw hole is 0-45 °). For another example, U.S. patent No. 10028777B2 discloses a bone implant comprising a matrix of fiber-reinforced polymer, especially an intramedullary nail structure, and in order to remove the nail, the said patent discloses two removal structures, a dovetail barb structure and a T-shaped structure, wherein the dovetail barb structure requires a new hole on the matrix, at this time, the hole easily grows into bone tissue, which makes the removal of the nail difficult, and the T-shaped structure requires a notched inner cavity to be added in the nail tail cap mounting hole, so that the T-shaped rod extends into the inner cavity and is rotationally locked, and then pulled outwards to remove the nail, but the T-shaped rod structure will be notched at the thread part, the thread strength will be reduced, the thread strength of the layered fiber composite material is very low, the probability of tooth breakage during processing and use is very high, and the T-shaped rod cannot be completely matched with the inner cavity, when the intramedullary nail is used, the moving space is large, relative shaking or sliding is easily caused, and the T-shaped structure only has 2 stress points and small contact area because the matrix is formed by laminated fiber reinforced polymers, so that the intramedullary nail is easily cracked, and the intramedullary nail is damaged. In summary, the conventional intramedullary nail has a good effect on the extraction of the metal intramedullary nail, but when the intramedullary nail is formed by the continuous fiber composite material, the mounting hole of the intramedullary nail sealing cap is easy to be broken or cracked when the conventional extractor or extraction device is used.

Disclosure of Invention

In order to solve the technical problems, the invention provides an orthopedic implant device, which comprises an intramedullary nail unit, a fixing unit and a tension fixing unit, wherein the intramedullary nail unit comprises an intramedullary nail main body, the fixing unit and the tension fixing unit, the intramedullary nail main body is made of continuous fiber composite materials, the intramedullary nail main body comprises a main body core and a main body shell, and the main body core is made of continuous fiber composite materials which are laid in a multi-layer mode and are molded; a fixing hole, a tension fixing hole and a cap sealing hole are formed in the intramedullary nail main body, wherein the cap sealing hole is formed in the main body core, a cap sealing is screwed in the cap sealing hole, the fixing unit is matched with the fixing hole, and the tension fixing hole is matched with the tension fixing unit; the nail taking device comprises a main nail taking device with a through hole and an auxiliary nail taking device, wherein one end of the auxiliary nail taking device extends into the through hole to stretch one end of the main nail taking device to form an expansion structure; the expansion cavity is of a frustum structure and is arranged in the cap sealing hole between the tension fixing hole and the threaded part of the cap sealing hole, the small end of the expansion cavity is connected with the threaded part of the cap sealing hole or is close to the threaded part of the cap sealing hole, and the surface of the expansion structure is attached to or partially attached to the side wall of the expansion cavity; when one end of the main nail extractor extends into the cap sealing hole and is expanded to form an expansion structure, the main nail extractor is not in contact with the threaded part of the cap sealing hole; wherein, the intramedullary nail main body is prepared by the following steps of continuous fiber composite materials: step 1, laying continuous fiber composite materials in multiple layers, and then putting the continuous fiber composite materials into a mold to form a core structure with a steel core through mold pressing; 2, winding the continuous fiber composite material on the outer surface of the molded core structure in an inclined way, and finally carrying out compression molding on the continuous fiber composite material and the core structure again to form a matrix of the intramedullary nail main body; step 3, carrying out mould pressing on the moulded matrix again at a certain temperature so as to bend various physiological anatomical angles; and 4, machining the bent matrix to form various hole sites and screw teeth so as to obtain the intramedullary nail main body with a main body core and a main body shell structure, wherein the main body core is formed by mould pressing and then processing the continuous fiber composite material which is laid in multiple layers in the step 1, in the main body core, the angle between the axial direction of the cap sealing hole and the laying direction of the continuous fiber composite material in the step 1 is 0-45 degrees, preferably 0 degree, when 0 degree is adopted, the bending strength of the intramedullary nail main body can be improved to the maximum extent, and the main body shell is formed by mould pressing and then processing the continuous fiber composite material which is obliquely wound in the step 2, so that the torsional strength of the intramedullary nail main body can be improved.

The side wall of the expansion cavity is a smooth surface, and the surface of the expansion structure is a smooth surface.

Furthermore, one end of the through hole of the main nail extractor forms a tapered structure, one end of the main nail extractor is an expansion end, at least two deformation grooves are formed in the circumferential direction of the expansion end, and one end of the auxiliary nail extractor extends into the tapered structure and props the expansion end to form an expansion structure.

Furthermore, the tapered structure comprises a cone frustum structure and a spherical cambered surface structure with holes, and one end of the auxiliary nail extractor extending into the through hole forms the spherical cambered surface structure.

Further, a main handle end is formed on the main nail extractor; an auxiliary handle end is formed on the auxiliary nail extractor, and an auxiliary hole is formed on the auxiliary handle end; form the internal thread on the lateral wall of through hole, form the external screw thread on the vice nail ware of getting, vice nail ware of getting stretches into behind the through hole, internal thread and external screw thread cooperation realize vice one end of getting the nail ware is propped open the main expansion end that gets the nail ware forms expanded structure.

Furthermore, the tension fixing unit comprises a tension fixing sleeve and a tension fixing bolt, the tension fixing sleeve penetrates through the tension fixing hole to be installed, the tension fixing bolt penetrates through the tension fixing sleeve to be installed, and the tension fixing bolt and the tension fixing sleeve form an interlocking fixing structure.

Furthermore, an anti-rotation block is formed on the tension fixing hole, and an anti-rotation groove matched with the anti-rotation block is formed on the tension fixing sleeve.

Further, a first developing structure is arranged on the intramedullary nail main body.

Further, the developing sleeve is arranged on the fixing hole and/or the tension fixing hole.

Further, the tension fixing unit is made of a continuous fiber composite material, and a second developing structure is arranged on the tension fixing unit.

Compared with the prior art, the technical scheme of the invention has the following advantages:

(1) the orthopedic implant device is made of the continuous fiber composite material, diagnosis is performed under the conditions of X-ray, CT and the like, no development is performed (a specific part is provided with a development structure), no artifact is generated, and misjudgment of doctors is avoided.

(2) The orthopedic implant device is made of continuous fiber composite materials, and due to the anisotropy and designability of the materials, the materials have high strength, modulus close to that of human bones and high fatigue, stress shielding after operation is reduced, and the implantation time of the materials in vivo is prolonged.

(3) The orthopedic implant device of the invention forms an expansion cavity in the hole of the sealing cap, and simultaneously the unit is taken out to form an expansion structure, the surface of the expansion structure is jointed or partially jointed with the side wall of the expansion cavity, a clamping force is formed between the expansion structure and the side wall, when the intramedullary nail is pulled out, the intramedullary nail is pulled out by the resultant force of the clamping force, meanwhile, a certain angle is formed between the resultant force of the clamping force and the axial direction of the seal cap hole, and also between the resultant force of the clamping force and the laying direction of the main body core, the resultant force direction of the clamping force is vertical to the side wall of the expansion containing cavity, the stress position and the stress direction of the thread part in the prior art are changed, so that the friction force and/or the acting compressive stress which originally acts on the thread part of the cap sealing hole are changed into the resultant force of the clamping force acting between the side wall of the expansion containing cavity and the surface of the expansion structure, and the cracking and the disintegration caused by the action of the friction force and/or the compressive stress on the thread teeth of the thread part of the cap sealing hole formed by the layered main body core are avoided; furthermore, the stress of the thread part is changed into the stress of the side wall of the expansion cavity, the stress area is enlarged, the stress strength is reduced by phase change, the damage to the inner wall of the hole of the intramedullary nail sealing cap is reduced, the intramedullary nail can be taken out of the medullary cavity by using the same extraction force without damaging the side wall of the expansion cavity, particularly when the expansion cavity is a frustum, and the expansion structure is close to the frustum structure; the structure can be well adapted to the taking out of the intramedullary nail of the main body core formed by laying and molding continuous fiber composite materials in multiple layers (the angle between the laying direction and the axial direction of the cap sealing hole is 0-45 degrees), and the intramedullary nail is prevented from being in thread contact with the inner thread of the cap sealing hole in the taking out process, so that the cracking and the fragmentation of the thread teeth of the thread caused by the contact with the thread or the expansion and the increase of the thread contact force are greatly avoided; meanwhile, redundant openings of the intramedullary nail main body are avoided being increased, tissue ingrowth is avoided, and nail taking difficulty is increased; meanwhile, the increase of the contact area correspondingly reduces the requirement of the shearing strength of the material, the stress is uniform, and the material cracking of the intramedullary nail, the serious damage to the intramedullary nail and even the difficulty in taking out caused by the fact that the local stress is overlarge and the pressure between layers is pulled apart are avoided.

(4) The tapered structure of the orthopedic implant device comprises a truncated cone structure and a spherical arc surface structure with holes, one end of the auxiliary nail extractor extending into the through hole forms the spherical arc surface structure, and the deformation of the expansion end of the auxiliary nail extractor is mild in the operation process through the design of the spherical arc surface structure, so that the side wall of the expansion cavity is prevented from being impacted due to the over-fast deformation, and the damage to the side edge of the expansion cavity is reduced.

(5) According to the orthopedic implant device, the tension fixing bolt and the tension fixing sleeve form an interlocking fixing structure, and the tension fixing bolt and the tension fixing sleeve are installed at a certain angle, so that loosening is avoided; furthermore, form on the pulling force fixed orifices and prevent revolving the piece, form on the pulling force fixed sleeve with prevent revolving the groove soon of preventing that piece looks adaptation for should prevent revolving structure convenient to use, reduce among the prior art through fixed knot structure fixed in the trompil on the intramedullary nail main part, further reduce the trompil operation of intramedullary nail main part, guarantee the intensity of intramedullary nail main part.

(6) According to the orthopedic implant device, the developing sleeve is arranged on the fixing hole and/or the tension fixing hole, so that the developing sleeve is used for achieving a larger developing effect and accurate positioning, and the developing sleeve is used for covering possible fiber leakage caused by punching.

Drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and it is obvious for those skilled in the art to derive other drawings without creative efforts.

Fig. 1 is a perspective view of an intramedullary nail unit of the present invention;

FIG. 2 is a perspective view of the intramedullary nail body of the present invention;

FIG. 3 is a cross-sectional view of the intramedullary nail body of the present invention;

FIG. 4 is a front view of the closure of the present invention;

FIG. 5 is a front view of the take-out unit of the present invention;

FIG. 6 is a schematic sectional view showing the structure of the take-out unit of the present invention;

FIG. 7 is an enlarged view at A in FIG. 6;

FIG. 8 is a perspective view of the tension set screw of the present invention;

FIG. 9 is a disassembled view of the tension set screw of the present invention;

FIG. 10 is a perspective view of the tension lock sleeve of the present invention;

FIG. 11 is a schematic structural view of a fixing hole setting developing structure of the present invention;

FIG. 12 is a schematic view of the structure of a developing polymer sleeve in which a tension fixing hole is provided according to the present invention;

FIG. 13 is a schematic view of the expanded end of the present invention expanded to form an expanded configuration;

FIG. 14 is a schematic structural view of the core-shell layer of the intramedullary nail body of the present invention;

FIG. 15 is an enlarged view taken at I in FIG. 14;

FIG. 16 is an enlarged view taken at II in FIG. 14;

FIG. 17 is a structural view showing a direction of a resultant force of a click force in the present invention;

the reference numbers in the figures denote: 1-intramedullary nail main body; 2-a fixation unit; 3-fixing holes; 4-a tension fixing hole; 5-capping the hole; 6-sealing the cap; 7-main nail extractor; 8-an expansion end; 9-auxiliary nail extractor; 10-an expansion volume; 11-a tapered structure; 12-deformation groove; 13-a main handle end; 14-secondary handle end; 15-auxiliary holes; 16-internal threads; 17-external threads; 18-a tension fixing sleeve; 19-a tension fixing bolt; 20-anti-rotation block; 21-anti-rotation groove; 22-developing sleeve; 23-a developing end; 24-a development bar; 25-tension fixing bolt main body; 26-a threaded sleeve; 27-a body core; 28 body shell.

Detailed Description

The present invention now will be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all embodiments of the invention are shown. The embodiments in the present invention, other embodiments obtained by persons skilled in the art without any inventive work, belong to the protection scope of the present invention.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present invention.

In addition, the technical features involved in the different embodiments of the present invention described below may be combined with each other as long as they do not conflict with each other.

Example 1

As shown in fig. 1-16, the present embodiment discloses an orthopedic implant device comprising an intramedullary nail unit comprising an intramedullary nail body 1, a fixation unit 2 and a tension fixation unit, the intramedullary nail body 1 being made of a continuous fiber composite material, the intramedullary nail body 1 comprising a body core 27 and a body shell 28, wherein the body core 27 is made of a multi-layered lay-molded continuous fiber composite material. The intramedullary nail main body 1 is prepared by the following specific steps:

step 1 (core molding): laying continuous fiber composite materials in multiple layers, and then putting the continuous fiber composite materials into a mould with a steel core to form a core structure by mould pressing; optionally, two halves are formed first and then embedded into the steel core to be molded into a whole; the pressure is 1-4MPa, preferably 2MPa, the temperature is 370-410 ℃, preferably 400 ℃, the pressure is maintained for 5-40 minutes, preferably 30 minutes, and the temperature reduction rate is 1-10 degrees/minute, preferably 5 degrees/minute.

Step 2 (shell molding): obliquely winding the continuous fiber composite material on the outer surface of the formed core structure, wherein the winding angle can be +/-30 degrees, 60 degrees or 45 degrees, and preferably +/-45 degrees; optionally, the sleeve can be woven by adopting various angles to be sleeved on the outer surface of the core; and finally, the intramedullary nail body 1 is formed again with the core.

And step 3: molding the molded matrix again at a certain temperature so as to bend various physiological anatomical angles; preheating the main nail at 400 ℃ for 10 minutes, pressing by a pressing machine, keeping the pressure at 1-4MPa, preferably 2MPa, the temperature at 370 ℃ and 410 ℃, preferably 400 ℃, keeping the pressure for 5-40 minutes, preferably 5 minutes, and reducing the temperature at the rate of 1-10 degrees/minute, preferably 10 degrees/minute.

And 4, step 4: and machining the bent matrix to form various hole positions and screw teeth, thereby obtaining the intramedullary nail main body 1 with a structure comprising a main body core 27 and a main body shell 28. Wherein, the main body core 27 is formed by mould pressing and post-processing the continuous fiber composite material which is laid in multiple layers in the step (1), and in the main body core 27, the angle between the axial direction of the sealing cap hole 5 and the laying direction of the continuous fiber composite material in the step (1) is 0-45 degrees, preferably 0 degree; the main body case 28 is molded and processed from the continuous fiber composite material wound obliquely in step 2.

It should be noted that the structure of the continuous fiber composite material used in step 1 and step 2 may be a unidirectional tape, a block, a strip, or the like, and a unidirectional tape is preferable. Of course, in step 2, the diagonal winding may also be laid at an angle to the core structure formed in step 1.

Of course, in step 1, a development mark may be added at the time of laying. The number of layers of the outer shell after the intramedullary nail body 1 is manufactured is not particularly limited, and in the present embodiment, 5 layers of the body shell 28 are provided outside the body core 27 as shown in fig. 14 to 16.

Wherein the matrix in the continuous fiber composite material is a thermoplastic polymer material or a thermosetting polymer resin. Wherein the thermoplastic polymer is selected from Polyaryletherketone (PAEK) or Polyetheretherketone (PEEK) or other polyketone-based polymers, in particular Polyetherketoneketone (PEKK), polyphenylene, polyphenylsulfone, polyamideimide, polyphenylsulfide or polysulfone, or the like. The thermosetting polymer resin is selected from epoxy resin or polyester or polyimide or bismaleimide, and can be reinforced by carbon and/or Ultra High Density Polyethylene (UHDPE) fiber. Of course, reference may also be made to aramid fibers, such as Kevlar ®, quartz, basalt, polyethylene, boron or glass available from DuPont. Optionally, two or more of these may be used together. Optionally, the fibers comprise 40 to 80 volume percent of the continuous fiber composite. In an exemplary embodiment, the fibers comprise 60 volume percent of the continuous fiber composite. The fiber adopts carbon fiber, and the matrix adopts PEEK resin.

A through hole, a fixing hole 3, a tension fixing hole 4 and a cap sealing hole 5 are formed in the intramedullary nail main body 1, wherein the cap sealing hole 5 is formed in the main body core 27, a cap sealing 6 is installed in the cap sealing hole 5, the cap sealing hole and the cap sealing hole are installed through threads, an internal thread is formed in the cap sealing hole 5, an external thread is formed on the cap sealing 6, the fixing unit 2 is matched with the fixing hole 3, in the embodiment, the fixing unit 2 is a fixing screw, and the material of the fixing unit can be common metal or continuous fiber composite material; the tension fixing hole 4 is matched with the tension fixing unit; the nail taking device further comprises a taking-out unit, wherein the taking-out unit comprises a main nail taking device 7 with a through hole and an auxiliary nail taking device 9, one end of the auxiliary nail taking device extends into the through hole to expand one end of the main nail taking device 7 to form an expansion structure; the expansion cavity 10 is of a frustum structure, the expansion cavity 10 is arranged in the cap sealing hole 5 between the tension fixing hole 4 and the threaded portion of the cap sealing hole 5, the small end of the expansion cavity 10 is connected with the threaded portion of the cap sealing hole 5 or close to the threaded portion of the cap sealing hole 5, and the surface of the expansion structure is attached to the side wall of the expansion cavity 10 or partially attached to the side wall of the expansion cavity. When one end of the main nail extractor 7 extends into the expansion containing cavity 10 through the thread part of the cap sealing hole 5 before being expanded, the main nail extractor 7 cannot contact or touch the thread part of the cap sealing hole 5, that is, at least the diameter of the outer diameter of the part of the main nail extractor 7 extending into the expansion containing cavity 10 through the thread part of the cap sealing hole 5 or the diameter of the circumscribed circle of the outer diameter is smaller than the inner diameter of the thread part of the cap sealing hole 5, and only when one end of the main nail extractor 7 is expanded to form an expansion structure, the part of the main nail extractor 7 extending into the cap sealing hole 5 cannot touch the thread part of the cap sealing hole 5. The side wall of the expansion cavity 10 is a smooth surface, the surface of the expansion structure is a smooth surface, and other structures can be selected for the side wall and the surface of the expansion structure, and the smooth surfaces are selected to facilitate processing and avoid burrs.

Specifically, the main nail ware 7 of getting is the body, just the main one end of getting the through hole of nail ware 7 forms tapered structure 11, just the main one end of getting nail ware 7 is expansion end 8, and its circumference sets up two at least deformation grooves 12, the one end of vice nail ware 9 of getting stretches into tapered structure 11 and with expansion end 8 struts and forms the expanded structure. As for the tapered structure 11, it is configured that one end of the secondary nail extractor 9 extends into the through hole, in this embodiment, the secondary nail extractor 9 is preferably a cylinder, and the extending end of the cylinder forms a spherical arc structure, and the tapered structure 11 is configured according to the diameter of the spherical arc structure, such as a spherical arc structure including a truncated cone structure and a perforated spherical arc structure, and as for the perforated spherical arc structure, there may be one or two connected structures, and in this embodiment, there are two connected structures. As for the deformation groove 12, it is generally strip-shaped, and as for the number or number thereof, four are preferable. As regards the structure of the expansion volume 10, in the present embodiment said expansion volume 10 has a truncated cone structure.

Further, a main handle end 13 is formed on the main nail extractor 7; the auxiliary nail extractor 9 is provided with an auxiliary handle end 14, the auxiliary handle end 14 is provided with an auxiliary hole 15, the torsion can be increased by using a rod body to penetrate through rotation through the auxiliary hole 15, and the main handle end 13 and the auxiliary handle end 14 are preferably of a cylindrical structure with a groove; form internal thread 16 on the lateral wall of through hole, form external screw thread 17 on the vice nail ware 9 of getting, vice nail ware 9 of getting stretches into behind the through hole, internal thread 16 and external screw thread 17 cooperation are realized vice one end of getting nail ware 9 is propped open slowly the expansion end 8 of mainly getting nail ware 7 forms expanded structure.

Further, the tension fixing unit comprises a tension fixing sleeve 18 and a tension fixing bolt 19, the tension fixing sleeve 18 penetrates through the tension fixing hole 4 to be installed, the tension fixing bolt 19 penetrates through the tension fixing sleeve 18 to be installed, and during installation, the external thread of the tension fixing bolt 19 is matched with the internal thread of the tension fixing sleeve 18 to be screwed in; the tension fixing bolt 19 and the tension fixing sleeve 18 form an interlocking fixing structure. Further, an anti-rotation block 20 is formed on the tension fixing hole 4, an anti-rotation groove 21 matched with the anti-rotation block 20 is formed on the tension fixing sleeve 18, when the patient recovers during installation, the anti-rotation block 20 is matched with the anti-rotation groove 21 to prevent the tension fixing sleeve 18 from rotating, the number of the rotating blocks 20 is not particularly limited, 2 symmetrical rotating blocks are preferred, and meanwhile, the outer side surface of the rotating block 20 is designed and transited in an arc surface mode; the anti-rotation block 20 also has a mounting guide function. As for the preparation material of the tension fixing unit, a common metal material can be used, a continuous fiber composite material can be used, and other polymers or a combination of polymers can be used.

Further, the intramedullary nail body 1 is further provided with a first developing structure, the position, specific structure and developing material of the first developing structure are not specifically limited, and the position is, for example, the fixing hole 3, the tension fixing hole 4 and the like of the intramedullary nail body 1, in this embodiment, the first developing structure is a developing sleeve 22, the structure of the developing sleeve 22 is set according to the use position, preferably, the fixing hole 3 and/or the tension fixing hole 4, as shown in fig. 12, the tension fixing hole 4 is set, and when in use, the developing sleeve 22 is prepared according to the specific installation position, and then is installed, and then is in interference fit; the developing material can be tantalum, titanium, stainless steel or barium sulfate polymer, preferably a developing sleeve 22 matched with a barium sulfate composite material, so as to realize the sleeve press fit matched with the PEEK/barium sulfate composite material, and the setting mode of the developing sleeve 22 can be that a finished sleeve is firstly manufactured and then is loaded and then trimmed, or a semi-finished sleeve or a semi-finished shape is firstly manufactured and then is put into a die to be extruded and molded and then is trimmed; of course, the first developing structure may have other shapes such as a bar, a block, a line, etc., and the position is not limited to the fixing hole 3 and/or the tension fixing hole 4, but may be along the length direction of the main body, as shown in fig. 11, which shows the developing block disposed in the fixing hole 3. Specifically, the developing material is pressed into the matching holes, and then machining is carried out, or the developing material is ground into micron-sized powder, a polymer is matched to prepare a polymer developing coating, the polymer developing coating is coated on a part needing developing, then the part is solidified on a main body or a nail, the PEEK is preferably selected as the polymer, the developing material is made into a thin rod or a block, corresponding clamping grooves are machined on the side surfaces of the tension nail holes or the fixing holes 3, and developing is used as the guide of the nail.

When the tension fixing unit is made of a continuous fiber composite material, a second developing structure is arranged on the tension fixing unit, the position, specific structure and developing material of the second developing structure are not specifically limited, and a developing point, a developing strip and the like can be selected as the specific structure, in the embodiment, the end part of the tension fixing sleeve 18 forms a developing end 23, the range is not specifically limited, and during preparation, developing material powder can be mixed into the material of the tension fixing sleeve 18; a developing rod 24 is arranged in the tension fixing bolt 19, and can be a titanium alloy rod; the developing material can use tantalum, titanium, stainless steel or barium sulfate polymer, can be powder, and can be in other specific shapes, strips, blocks and the like; preferably, the tension fixing bolt 19 is composed of two parts, a tension fixing bolt main body 25 and a bolt sleeve 26, wherein the tension fixing bolt main body 25 is made of a continuous fiber composite material, the bolt sleeve 26 is made of metal, the tension fixing bolt main body 25 is completed through interference fit or co-molding, and meanwhile, a developing rod 24 is arranged in the tension fixing bolt main body 25. As for the thread of the tension fixing bolt 19, a rectangular thread is used.

Of course, the tension fixing unit may be a separate tension bolt made of a continuous fiber composite material, and may be provided with a developing mark, such as the developing rod 24, during the manufacturing process.

The using process of the invention is as follows:

when the intramedullary nail needs to be taken out, the fixing unit 2 and the tension fixing unit are removed, the sealing cap 6 is removed, the taking-out unit is extended into the sealing cap hole 5, the auxiliary nail extractor 9 is slowly screwed, the expansion end 8 of the main nail extractor 7 is expanded to form an expansion structure close to a frustum structure, the expansion structure is attached to or partially attached to the side wall of the expansion containing cavity 10 in the sealing cap hole 5, then the taking-out unit and other auxiliary structures are pulled, and at the moment, as shown in fig. 17, the intramedullary nail is taken out through the resultant force F of the clamping force formed between the expansion structure and the auxiliary structures.

As regards the direction of the resultant force F of the snap-in forces, as shown in fig. 17, perpendicular to the expansion volume side wall, at an angle to the axial direction of the capping hole 5 and also at an angle to the direction of laying of the body core, which in fig. 17 is laid (for example at 0 °) as a filler wire structure in a cross-sectional view of the intramedullary nail body 1.

It should be understood that the above examples are only for clarity of illustration and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. And obvious variations or modifications therefrom are within the scope of the invention.

Claims

1. An orthopedic implant device is characterized by comprising an intramedullary nail unit, wherein the intramedullary nail unit comprises an intramedullary nail main body, a fixing unit and a tension fixing unit, the intramedullary nail main body is made of continuous fiber composite materials, the intramedullary nail main body comprises a main body core and a main body shell, and the main body core is made of continuous fiber composite materials which are laid and molded in multiple layers; a fixing hole, a tension fixing hole and a cap sealing hole are formed in the intramedullary nail main body, wherein the cap sealing hole is formed in the main body core, a cap sealing is screwed in the cap sealing hole, the fixing unit is matched with the fixing hole, and the tension fixing hole is matched with the tension fixing unit; the nail taking device comprises a main nail taking device with a through hole and an auxiliary nail taking device, wherein one end of the auxiliary nail taking device extends into the through hole to stretch one end of the main nail taking device to form an expansion structure; the expansion cavity is of a frustum structure, the expansion cavity is arranged between the tension fixing hole and the threaded portion of the sealing cap hole, the small end of the expansion cavity is connected with the threaded portion of the sealing cap hole or close to the threaded portion of the sealing cap hole, and the surface of the expansion structure is attached to or partially attached to the side wall of the expansion cavity.

2. The orthopedic implant device of claim 1, wherein one end of the through hole of the primary staple remover is formed into a tapered structure, one end of the primary staple remover is an expanded end provided with at least two tapered grooves circumferentially, and one end of the secondary staple remover extends into the tapered structure and expands the expanded end into an expanded structure.

3. The orthopedic implant device of claim 2, wherein the tapered structure is a spherical-arc structure comprising a truncated cone structure and a hole, wherein the end of the secondary staple remover extending into the through-hole forms a spherical-arc structure.

4. The orthopedic implant device of claim 3, wherein the primary staple remover has a primary handle end formed thereon; an auxiliary handle end is formed on the auxiliary nail extractor, and an auxiliary hole is formed on the auxiliary handle end; form the internal thread on the lateral wall of through hole, form the external screw thread on the vice nail ware of getting, vice nail ware of getting stretches into behind the through hole, internal thread and external screw thread cooperation realize vice one end of getting the nail ware is propped open the main expansion end that gets the nail ware forms expanded structure.

5. The orthopedic implant device of any of claims 1-4, wherein the tension fixation unit comprises a tension fixation sleeve and a tension fixation bolt, the tension fixation sleeve is installed through the tension fixation hole, the tension fixation bolt is installed through the tension fixation sleeve, and the tension fixation bolt and the tension fixation sleeve form an interlocking fixation structure.

6. The orthopedic implant device of claim 5, wherein the tension fixation hole is formed with an anti-rotation block, and the tension fixation sleeve is formed with an anti-rotation groove adapted to the anti-rotation block.

7. The orthopedic implant device of claim 6, wherein the intramedullary nail body has a first visualization structure disposed thereon.

8. The orthopedic implant device of claim 7, wherein the fixation holes and/or the tension fixation holes are provided with a visualization sleeve.

9. The orthopedic implant device of claim 8, wherein the tension fixation unit is made of a continuous fiber composite material with a second visualization structure disposed thereon.