JP2018033671A - Gamma type nail device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a gamma type nail device that facilitates observation of an affected area without being affected by the presence or absence of X-ray transparency in the X-ray surgical operation and X-ray diagnosis, and can also use a space in the nail.SOLUTION: A nail 4, a lag screw 2, a horizontal stopper screw 5 and further an end cap 6 are made by a PEEK resin carbon-fiber composite. The nail 4 and the lag screw 2 are configured such that the PEEK resin is impregnated in the tube obtained by cross-knitting of the UD tape 16 making a roving bundle band, or the UD tape 10 obtained by impregnating the PEEK resin in the roving bundle band is cross-knitted, and heating and pressurization are performed to make a cylindrical shape, respectively, and then the cross-knitted tube 17 being cooled and solidified or a cross-braided tube 11 is formed. Inner shells 13A, 13B and outer shells 15A, 15B for covering the tube cylinder surface are also included.SELECTED DRAWING: Figure 1

Description

  The present invention relates to a gamma-type nail device, and is a fixing device of a type in which a hollow rod is inserted into a bone marrow cavity and a fractured bone head is fixed with a screw. This is related to a gamma type nail that is pulled and fixed to a nail embedded in the bone marrow cavity by screwing and is prevented from coming off by a lateral screw.

  When using a gamma-type nail to assist in the repair of a fracture, a lag screw is screwed into the cancellous bone inside the head, and the screw is attached to a nail that is fixed to the femur, and the fractured head is connected to the femur. In other words, it is possible to integrate the head and femur via a gamma-type nail, or to enable integration of the humeral head and humerus, and serve as an aid for early repair of fractures and injuries. . By the way, the name "gamma" is derived from the fact that the lag screw and the rod-shaped nail (intramedullary nail) form the letter "γ" by inserting the lag screw diagonally upward from the middle part of the nail. To do.

  This gamma-type nail is composed of a nail, a lag screw, a lateral screw described later, an end cap of the nail, etc., all of which are required to be safe for a living body and are usually made of a titanium alloy. For example, JP-A-2013-2400555 and JP-A-2013-2400556 describe gamma-type nails, but improvements in shape and structure are discussed on the assumption that the material is metal. Needless to say, machining of titanium requires time and effort, and preparing a product of a dimension suitable for the individual (patient) to be applied has a great influence on the price.

  The biggest difficulty of the metal gamma nail is that it does not have X-ray transmission function, and this early repair aid hinders the rear view. Not only at the time of treatment, but also in post-diagnosis diagnosis, it is very obtrusive, hindering confirmation of recovery and progress. In addition, metals have limited fatigue strength and are sometimes forced to be replaced. In addition, although the nail is a hollow product, in order to use its internal space, it is not easy to form a circulation hole with the outside or modeling of the holding structure of the container, and if a circulation hole is provided, The presence of the small holes invites a decrease in the fatigue strength of the metal material, which is not preferable.

JP2013-2400555A JP2013-2400556A

  The present invention has been made in view of the above-mentioned problems, and its purpose is to use an apparatus having a femoral and humerus damaged head as an effect of the presence or absence of X-ray permeability in X-ray monitoring and subsequent X-ray diagnosis. That makes it easy to observe the affected area without suffering from the damage, does not cause material fatigue as a holding device, can sustain the function semi-permanently, and also causes adverse effects when trying to use the space inside the nail It is to provide a gamma-type nail device that never happens.

The present invention relates to a gamma type in which a bone head that is likely to fall off or has been dropped is attracted and fixed to a nail embedded in a bone marrow cavity by screwing a lag screw so that the removal of the nail is prevented by a lateral screw. Applies to nails. Refer to FIG. 1 for the features.
PEEK resin carbon fiber composite material nail 4 is inserted obliquely upward from the middle part of the nail 4 to form a γ-shaped lag screw 2 and a lateral locking screw that penetrates the distal portion of the nail 4 substantially horizontally. 5, and also the end cap 6 screwed into the proximal portion of the nail 4 is made of PEEK resin carbon fiber composite material.
The nail 4 and the lag screw 2 are cross-knitted tubes in which PEEK resin is impregnated into a tube in which a UD tape 16 (see FIG. 6) forming a roving bundle is cross-knitted, heated and pressed into a cylindrical shape, and then cooled and solidified. 17 or a cross-networked tube 11 cross-knitted with a UD tape 10 (see FIG. 3) impregnated with PEEK resin in a roving bundle, and heated and pressed into a cylindrical shape, and then cooled and solidified, and the tube In order to cover the tube surface, the UD tape 12 is laminated with orientations of 0, 90, 45, and -45 degrees with respect to the tube axis direction, and the upper and lower semicircular cross sections solidified after heating and pressurization. After the UD tape 14 is cross-oriented and laminated to cover the inner shells 13A and 13B (see FIG. 4) and the entire inner shells 13A and 13B by shifting 90 degrees from the mating portions. The shell 15A of the semicircular arc cross-section of the solidified in heating and after pressurization right and left, and a 15B (see Figure 5).
The transverse screw 5 includes a cross knitted tube 17 in which PEEK resin is impregnated into a tube obtained by cross knitting a UD tape 16 (see FIG. 6) forming a roving bundle, and a UD tape 18 for covering the tube surface of the cross knitted tube. And a covering 19 having a semi-circular cross-section with a double crack shape, which is oriented and laminated in the tube axis direction and solidified after heating and pressing. And
The upper and lower inner shells 13A and 13B and the right and left outer shells 15A and 15B are combined and placed in an injection mold with a round bar core inserted in the tube, and fiber chips are mixed. The molten PEEK resin compound is press-fitted to form the surface layer / shell, and the resin 20 in the combination is integrated by remelting with the molten compound to form a thread 20 (see FIG. 7) and Each tip of the molded product is shaped by the melt compound, and after the mold of the injection mold is opened, any core is removed to make the molded product hollow.

  When the cross knitted tube 17 is formed by impregnating PEEK resin into a tube knitted with a UD tape 16 forming a roving bundle band so as to form a hollow pipe shape (see FIG. 7), only the carbon fiber is cross knitted. It is assumed that the PEEK resin film is applied to only the outer surface or the inner and outer surfaces of the carbon tube, and the PEEK resin is impregnated by heating and pressing.

  When the cross netting tube 11 is formed by cross-knitting the UD tape 10 in which the roving bundle band is impregnated with PEEK resin (see FIG. 3), the tube 11 is heated to form a hollow pipe by the triaxial braiding method. The PEEK resin-impregnated UD tape 10 may be a triaxial mesh assembly.

  The triaxial braiding of the roving bundle band is to form a reticulated winding layer by the UD tape 10 oriented so as to intersect with the longitudinal direction (the axial direction of the tube) with an inclination and a reverse inclination. In this case, when the UD tape 10 impregnated with PEEK resin is fed, it is assumed that the mesh-like winding layer is passed through a heating head for heating.

  As shown in FIG. 7, the lag screw 2 is composed of a screw portion that is screwed into the cancellous bone inside the head 1 and a journal portion 2B that is pivotally supported at an intermediate portion of the nail 4, and a lug at the end opposite to the screw. A wrench engaging portion 25 for screwing the screw 2 is formed.

  A hole 21 (see FIG. 2) through which the lag screw 2 provided in an intermediate portion of the nail 4 is inserted is formed by drilling after molding of the molded product from which the core has been removed to form a hollow body.

  A bushing having the same knitting structure as that of the cross knitted tube 17 or the cross braided tube 11 is fitted into a hole 21 (see FIG. 2) through which the lag screw 2 provided in an intermediate portion of the nail 4 is inserted.

  In the lamination of the UD tapes 12, 14, and 18 in the inner shells 13 </ b> A and 13 </ b> B, the outer shells 15 </ b> A and 15 </ b> B, and the covering 19, the number of plies is different depending on the nail portion.

  A UD tape 22 (see FIG. 3) extending in the longitudinal direction may be mixed with the mesh winding layer.

  A stainless steel wire 23 (see FIG. 9A) extending in the longitudinal direction is laid on the mesh winding layer.

  The end cap 6 (see FIG. 8) is formed by a molding die for injecting a molten compound independently of the nail and lag screw, and the male screw 24 formed at the end cap end is solid.

  As shown in FIG. 8, a small hole 26 extending from the outer layer of the nail 4 to the internal cavity is opened, and the drug contained in the internal cavity 27 (a biodegradable carrier is mixed with a bone growth stimulating agent or an antibiotic for preventing infection) Is provided with a medicinal function capable of exuding and releasing from the surface of the nail to the cancellous bone 29 in particular.

  As shown in FIG. 8, a small hole 31 extending from the outer layer of the lag screw 2 to the inner cavity 28 is opened, and a drug contained in the inner cavity (a biodegradable carrier is mixed with a bone growth stimulating agent or an antibiotic for preventing infection) Is provided with a medicinal function capable of exuding and releasing from the surface of the lag screw to the cancellous bone 29 in particular.

  According to the present invention, the nail, lag screw, side screw, and end cap that constitute the gamma type nail device are all made of PEEK resin carbon fiber composite material, so that it is extremely light compared to the metal gamma type nail device. And reduce the static and dynamic burden on the affected area. X-ray permeability is also exhibited, and the gamma-type nail device does not hinder the observation of the affected part in postoperative diagnosis, and the degree of recovery and the like can be confirmed very easily. Also, unnecessary procedures are avoided because it does not react to metal detectors at airports.

  The fatigue strength of a gamma-type nail device made of a resin carbon fiber composite material is very high compared to that of a metal device, enabling an increase in service life and reducing the chance of re-treatment. Because it is a resin molded product, it is easy to form cavities inside the nail and lag screw, which gives room for additional mechanisms and functions. Since the fatigue strength is low, it is not a problem to have a structure with a resin wall through hole by adding a mechanism or adding a function.

  Nail and lag screw are equipped with a cross netted tube, upper and lower semi-circular cross-section inner shells, and right and left semi-circular cross-section outer shells. In particular, the inner shell body is specialized in a structure that exhibits bending and twisting strength, and the outer shell body is reinforced in a structure that suppresses torsional strength reduction due to cross-sectional defects due to insertion holes provided in the nail. Accordingly, a gamma-type nail device that exhibits a load sharing function with little excess or deficiency can be obtained.

  The cross knitted tube is made by impregnating PEEK resin into a tube knitted with UD tape forming a roving bundle, and the cross-woven tube is made by cross knitting UD tape impregnated with PEEK resin in a roving bundle, It is assumed that it is cooled and solidified after it is made into a cylindrical shape, but by diversifying its molding and manufacturing procedures, it is possible to select flexible processes with choices for those who produce patient-friendly fittings It becomes like this.

  The inner shell consists of the upper and lower semicircular cross sections obtained by laminating UD tape at 0, 90, 45 and -45 degrees orientation with respect to the tube axis direction and solidifying after heating and pressing. Since it is made into a shell, setting in the injection mold by covering the cylindrical surface of the cross netting tube is extremely facilitated. In addition, if the insertion holes for the lag screw are formed at the upper and lower mating edges, the influence on the twisting strength of the oriented UD tape due to the cross-sectional defect of the inner shell can be minimized.

  The outer shell is formed by cross-orientating lamination of UD tapes, and then solidified after heating and pressurizing, so that the outer shell has a semicircular cross section on the right and left sides, and the entire inner shell is shifted by 90 degrees from the mating portion. Since the inner shell body of the right and left semicircular cross sections is covered, the setting in the injection mold by covering the outer surface of the inner shell body is facilitated. Moreover, the complementary effect of the torsional strength can be exhibited in the vicinity of the mating edge of the inner shell whose strength is reduced by the insertion hole for the lag screw.

  Since the transverse screw is provided with a cross-knitted tube and a cover with a cracked shape, the tube is specialized in a structure that exhibits torsional resistance, and a structure with a bending strength that is provided with a double-cracked cover. It is possible to specialize and to exhibit sufficient strength to prevent the lateral movement of the nail embedded in the bone marrow cavity. In addition, if the cross knitted tube is made by impregnating PEEK resin into a tube knitted with a UD tape forming a roving bundle, a commercially available carbon fiber tube can be used, which can contribute to lowering the cost of the gamma type nail device. it can.

  With the round bar core inserted in the tube, the right and left outer shells, the upper and lower inner shells are combined and placed in an injection mold, and the molten PEEK resin compound with mixed fiber chips is placed. Press-fit to shape the surface layer and shell, and to reintegrate each resin in the combination by re-melting with a molten compound, forming the screw thread part and each tip of the molded object by the molten compound, Any hollow core can be removed after the injection mold is opened to realize a hollow product.

  If a cross-knitted tube is impregnated with PEEK resin by applying PEEK resin film only on the outer surface or inner / outer surface of a carbon tube that is cross-knitted with carbon fiber only, the UD tape forming the roving bundle is crossed. A hollow pipe can be formed by a knitted tube. That is, it is possible to suppress a rise in the gamma nail apparatus using a commercially available carbon fiber tube.

  If the UD tape impregnated with PEEK resin heated by the triaxial braiding method is used as a crossed network tube with a triaxial mesh, a hollow pipe with a tube in which a UD tape impregnated with PEEK resin in a roving bundle is cross knitted. The shape can be made. This cross netting tube can be obtained with a thickness greater than that of a commercially available carbon fiber tube, and it is possible to improve the quality of nails and lag screws by using a strong cross netting tube with excellent torsional rigidity.

  Since the triaxial braiding of the roving bundle band is formed by forming a mesh-like wound layer with a UD tape oriented so as to intersect with the longitudinal direction (the axial direction of the tube) with an inclination and a reverse inclination, the torsional rigidity is extremely high. In addition, the load resistance against dynamic loads and repeated loads from the patient's body is also strong.

  When a PEEK resin-impregnated UD tape is fed out in triaxial braiding, a dense cross-meshing tube can be obtained which is easy to increase the volume of the mesh winding layer and passes through a heating head for heating.

  The lag screw consists of a screw part that is screwed to the cancellous bone in the bone head and a journal part that is pivotally supported at the middle part of the nail, and a wrench engaging part for screwing the lag screw is formed at the opposite end of the screw If so, the attachment to the nail is very smooth. The function as a lag screw can be fulfilled sufficiently, and the structure and the function are stable.

  If the insertion hole is formed by drilling after the nail that has been hollowed out by removing the core is formed, it is possible to reliably provide the lag screw support mechanism provided in the intermediate portion. .

  If the cross knitted tube or cross braided tube and the bushing with the same material and knitted structure are fitted in the hole through which the lag screw is inserted, the cavity of that part of the nail is closed, and the lag screw's The shaft support is made on a support surface with high torsional rigidity, which is smooth and reliable.

  The lamination of the UD tape in the inner shell, the outer shell, and the cover can be made as a laminated structure adjusted so that the bending strength is not improved or excessive or insufficient if the number of plies is different depending on the nail site. .

  If a UD tape extending in the longitudinal direction is also mixed with the mesh winding layer, the yield strength against bending and tensile force can be increased.

  If the stainless steel wire extending in the longitudinal direction is laid on the mesh winding layer, X-rays do not pass through only that part, and the position of the nail or lag screw that is in the shadowed state is improved by increasing the permeability. be able to.

  The end cap is formed by a mold that injects the melt compound independently of the nail or lag screw. If the male screw formed at the end cap end is solid, the end cap is not bent or force-operated. This makes it easy to provide a threaded structure with a nail holding jig (for example, a fragment control grip) used during surgery.

  If a small hole from the outer layer of the nail and lag screw to the inner cavity is opened so that the drug contained in the inner cavity can be released slowly from the surface of the nail or lag screw, the introduction of the nail or lag screw Bone growth stimulants and antibiotics for preventing infection can be gradually supplied to damaged cancellous bone, etc. over time, promoting bone quality and resuscitation, and speeding up postoperative recovery. That is, for example, a gamma nail device having a medicinal function for one month or more can be obtained.

It is a gamma type nail device concerning the present invention, and is a whole schematic diagram showing signs that a lag screw is fixed by a nail embedded in a femur and fixation of a bone head is aimed at. A nail unit is shown, (a) is a longitudinal sectional view, (b) is an external view, and (c) is a plan view. It is an external view of the mesh winding layer of the cross braided tube in a nail and a lag screw, (a) is a mesh winding layer only of a cross UD tape, (b) is a mesh winding with which the UD tape extended in a longitudinal direction is also mixed. layer. The perspective view when it is going to overlap an inner shell on a cross netting tube. The perspective view at the time of covering the cross netting tube with which the inner shell was piled up with an outer shell. The perspective view at the time of covering the cross-knitting tube for a transverse screw with a covering. A lag screw is shown, (a) is a longitudinal cross-sectional view, (b) is an external view. The gamma type nail device of a drug carrying structure is shown, (a) is an external view, (b) is a sectional view showing a state in which a drug is slowly released into the femur. (A) is an example in which a gamma-type nail device is applied to the humerus, (b) is a cross braided tube or cross braided tube embedded with a sunless wire that reacts to X-rays to give the operator information on position and posture. The schematic diagram of a state of being.

  Below, the gamma type nail device concerning the present invention is explained in detail based on a drawing. This is because the bone head 1 that may or may not fall off as shown in FIG. 1 is pulled and fixed to the nail (innerum nail) 4 embedded in the medullary cavity 3 by screwing the lag screw 2 so that the nail is pulled out sideways. It is a device that is blocked by a set screw 5. The term “gamma” has already been described by inserting the lag screw 2 obliquely upward from an intermediate portion of the nail 4 in the vertical position, but the lag screw and the rod-shaped nail are substantially “γ”. By taking the form of letters.

  The gamma-type nail device disclosed here is a bone head fixing device having a nail 4, a lag screw 2, a transverse screw 5, and an end cap 6. It should be noted that all of them are PEEK ( Polyether ether ketone) resin carbon fiber composite material. Although the nail 4 is embedded in the bone marrow cavity 3, for example, it is only fitted into the femur 7, so that a hole 8 (see FIG. 2) is formed in the distal portion of the nail 4, and the femur 7 and the side screw 5 which crosses the nail 4 substantially horizontally are indispensable. Further, an end cap 6 is screwed to keep the proximal portion, that is, the top portion of the nail 4 closed. This is because, although the nail 4 immediately after implantation is in the bone marrow cavity 3, a female screw 9 for screwing the tip of a fragment control grip (not shown) or the like that prevents the posture of the nail from changing during the operation. (See FIG. 2 (a) and FIG. 8 (a) described later) is formed on the top of the nail 4, and the end cap 6 closes the opening formed on the top of the nail when the grip is removed in the second half of the treatment. It is for keeping. In addition, this fragment control grip is substantially C-shaped, and the body torso is arranged outside the femur, and it also informs the practitioner of information (index) of the nail embedding position and posture, Omit the details.

  The above-described nail 4 and lag screw 2 are cross-woven tube 11 (a UD tape 10 impregnated with PEEK resin in a roving bundle is cross-knitted at 45 degrees, heated and pressed into a cylindrical shape, and then cooled and solidified. In order to cover the cross-knitted tube cylinder surface, the UD tape 12 is laminated at orientations of 0, 90, 45, and -45 degrees with respect to the tube axis direction, and then heated and heated. The inner shells 13A and 13B having the upper and lower semicircular arc cross sections shown in FIG. 4 solidified after pressing and the entire inner shells are shifted by 90 degrees from the mating portions to cover the UD tape 14 in a cross orientation. After the lamination, the outer and outer shell bodies 15A and 15B having a semicircular cross section on the right side and the left side shown in FIG.

  On the other hand, as shown in FIG. 6, the transverse screw 5 is used to cover a cross knitted tube 17 in which PEEK resin is impregnated into a tube obtained by cross knitting a UD tape 16 forming a roving bundle, and a tube surface of the cross knitted tube. A UD tape 18 is oriented and laminated in the tube axis direction, and is provided with a cover 19 having a semicircular arc cross-section having a half crack shape that is solidified after heating and pressurization.

  Next, the integration of these components is performed as follows. At that time, not only integration but also external modeling and functional site formation are performed. First, the upper and lower inner shells 13A and 13B are overlapped (see FIG. 4) with the round rod-shaped cores (not shown) inserted in the crossed net tube 11 described above (see FIG. 4), and the outer right and left outer sides are overlapped. The shells 15A and 15B are combined so as to be horizontally applied (see FIG. 5), and placed in an injection mold (not shown). The molten high-temperature PEEK resin compound mixed with fiber chips is pressed to form the surface layer / shell, and each resin in the combination is re-melted by the retained heat of the molten compound for integration. The part for molding the screw thread 20 shown in FIG. 7 and the shaping of each tip of the molded product are made by this melting compound. If any core is removed after the mold of the injection mold is opened, a hollow molded product is obtained.

  As can be seen, all of the nail 4, the lag screw 2, the transverse screw 5, and the end cap 6 constituting the gamma type nail device are made of PEEK resin carbon fiber composite material. In comparison, it is extremely lightweight and reduces the static and dynamic burden on the affected area. Needless to say, X-ray transparency and MRI compatibility are exhibited. The accuracy of the image diagnosis is improved, and the observation of the affected area in the postoperative diagnosis is not hindered, so that it is very easy to confirm the progress of recovery. Also, unnecessary procedures are avoided because it does not react to metal detectors at airports.

  The fatigue strength of a gamma-type nail device made of a resin carbon fiber composite material is very high compared to that of a metal device, which makes it possible to extend the service life and minimize the chance of re-treatment. Since it is a resin molded product, it is easy to form cavities inside the nail or lag screw, and this is used to provide room for additional mechanisms and functions (see the medicinal structure described later). Since the fatigue strength is low, it is not a problem to have a structure with a hole penetrating the resin wall where stress is likely to concentrate. Moreover, since it is stable without corrosion or hydrolysis, the durability is very high.

  The nail 4 and the lag screw 2 are provided with a cross-meshing tube 11, inner shells 13A and 13B having upper and lower semicircular cross sections, and outer shell bodies 15A and 15B having right and left semicircular cross sections. The cross netting tube 11 is specialized in a structure that exhibits torsional resistance, the inner shells 13A and 13B are specialized in a structure that exhibits bending and twisting resistance, and the outer shells 15A and 15B are provided on the nail 4. A gamma-type nail device that exhibits a load-sharing function with little excess or deficiency according to each part by virtue of a structure for suppressing a decrease in torsional strength due to a cross-sectional defect by an insertion hole 21 for a lag screw (see FIG. 2). be able to.

  The cross knitted tube 17 is obtained by impregnating PEEK resin into a tube formed by cross knitting a UD tape 12 forming a roving bundle, and then cooling and solidifying the tube by heating and pressing to form a cylindrical shape. Is a cross-knit UD tape 10 impregnated with PEEK resin in a roving bundle, heated and pressed to form a cylindrical shape, and then cooled and solidified. Makes it easy to select flexible fitting and shaping processes with options for the manufacturer.

  By the way, when it is set as the cross netting tube 11 which cross-knitted the UD tape 10 which impregnated PEEK resin in the roving bundle band, the triaxial braiding method was used to make the PEEK resin-impregnated UD tape 10 heated by the triaxial braiding method. It should be. According to this, it is possible to form a hollow pipe with a tube in which the UD tape 10 in which the roving bundle band is impregnated with PEEK resin is cross-knitted. This cross-meshing tube can be made thicker than commercially available carbon fiber tubes, and can obtain a strong tube with excellent torsional rigidity, achieving a structure and quality that are convenient for the nail 4 and lag screw 2 To do.

  The triaxial braiding of the roving bundle band is to form a reticulated winding layer by the UD tape 10 oriented so as to intersect with the longitudinal direction (the axial direction of the tube) by 45 degrees and reversely inclined. Previously, delamination that occurred when winding high-performance composite materials could not be removed, and buckling failure was often caused by torsional load. However, according to the triaxial braiding of this roving bundle, the torsional rigidity Is extremely high, and the load resistance against dynamic loads and repeated loads from the patient's body is also strong.

  At the time when the UD tape 10 impregnated with PEEK resin is fed out, it is necessary to melt the PEEK resin. This is because, by passing through this forming head, it is easy to increase the volume of the mesh winding layer, and a dense cross-knitted tube can be obtained.

  As shown in FIG. 3B, a UD tape 22 extending in the longitudinal direction is often mixed with the mesh winding layer. In this case, it goes without saying that the yield strength with respect to bending and tensile force becomes remarkable. The triaxial braiding method is to seamlessly form a carbon fiber from three ends into a uniform structure while incorporating carbon fiber in three directions. In that case, the braided yarn is impregnated with PEEK resin and heated with a UD tape. The above-mentioned UD tape 22 functions as a center yarn extending so as to pass through the braided yarn at the intersection, for example, with the braided angle 10 (inclination angle with respect to the longitudinal direction) being 45 degrees. The cross UD tape 10 effectively exhibits a counter force when twisting acts on the tube (see, for example, Japanese Patent No. 3624178).

  The lamination of the UD tape in the inner shells 13A and 13B, the outer shells 15A and 15B, and the covering 18 has a laminated structure in which the number of plies is changed depending on the nail portion and the bending strength is adjusted so as not to be improved or excessive or insufficient. I can leave. The inner shells 13A and 13B were formed by laminating the UD tape 12 (see FIG. 4) at orientations of 0 degrees, 90 degrees, 45 degrees, and −45 degrees with respect to the tube axis direction, and solidifying after heating and pressing. Since the upper and lower semicircular arc sections are used, setting in the injection mold by covering the cylindrical surface of the cross-knitted tube is facilitated. Further, if the insertion holes 21 for the lag screw 2 are formed at the upper and lower mating edges, the influence on the twisting strength of the oriented UD tape 10 due to the cross-sectional defect of the inner shell bodies 13A and 13B is minimized.

  The outer shells 15A and 15B are the right and left outer shells 15A and 15B, which are solidified after heating and pressurization after the UD tape 14 is cross-oriented and laminated, and these are the inner shells 13A and 13B. Since the inner shells 13A and 13B have a semicircular arc cross section on the right and left sides that cover the entire portion by shifting 90 degrees from the cross-sectional view from the mating portion, the inside of the injection mold covering the outer surfaces of the inner shells 13A and 13B Easy to set up. Moreover, the complementary effect of the torsional strength in the vicinity of the mating edge of the inner shells 13A and 13B having the reduced yield strength can be exhibited by the insertion hole for the lag screw 2. According to the outer shells 15A and 15B, the fibers are cut in the drilling process in the next step, but the load can be transmitted by additionally laminating the “lateral reinforcing structure” from the lateral direction. it can. By the way, when the inner shell and outer shell are manufactured, the UD tape cut to the appropriate size is temporarily fixed at the welding spot when it is placed in the dedicated mold for the inner shell or outer shell. In addition, it is only necessary to suppress the arrangement disorder due to the inflow of the molten resin.

  Since the transverse screw 5 includes the cross knitted tube 16 and the cover 19 having a two-crack shape, the tube is specialized in a structure that exhibits a twist resistance, and the cover 19 having a two-split shape has a bending strength. Specializing in the structure to be exerted, it can be finished to have a strength sufficient to prevent the lateral movement of the nail embedded in the bone marrow cavity. If the cross-knitted tube is made by impregnating PEEK resin into a tube knitted with UD tape 16 forming a roving bundle, a commercially available carbon fiber tube can also be used, which contributes to cost reduction. Can do.

  By the way, in forming and shaping as a gamma-type nail device, first, the right and left outer shells 15A and 15B, the upper and lower inner shells are inserted with a round bar-like core (not shown) inserted into the tube. The bodies 13A and 13B are combined and placed in an injection mold, and a melted PEEK resin compound in which fiber chips are mixed is press-fitted to form a surface shell and a surface layer, and remelting of each resin in the combination by melting compound Thus, the parts that form the threads and the tips of the molded product are shaped by the melt compound.

  As shown in FIG. 9B, a stainless steel wire 23 extending in the longitudinal direction is preferably laid on the mesh winding layer. X-rays do not pass through only that part, and this laying wire teaches the position and posture of the nail 4 and lag screw 2 that are in the shadowed state due to the increased permeability.

  The above-described end cap 6 is formed by a molding die for injecting a molten compound independently of the nail 4 and the lag screw 2. The male screw 24 (see FIG. 8A) formed at the end cap end is a solid body. It is easy to form an end cap that does not act on bending or force, and it is easy to give a screwing structure in a nail holding jig used during surgery. The female screw 9 to which the male screw 24 is screwed is a uniting means with the fragment control grip as described above.

  The lag screw 2 is composed of a screw portion 2A shown in FIG. 7 that is screwed into the cancellous bone in the inside of the bone head 1, and a journal portion 2B that is pivotally supported at an intermediate portion of the nail 4, but at the opposite end of the screw. A wrench engaging portion 25 for screwing the lag screw 2 is formed, and a rotational force that makes the attachment to the nail smooth can be given. The function as a lag screw becomes stable, and the physical burden on the patient is eased.

  The hole 21 (see FIG. 2) through which the lag screw 2 provided in the intermediate portion of the nail 4 is inserted is formed by drilling after molding of the molded product from which the core has been removed to form a hollow body. According to this machining, it is possible to reliably form a hole through which the lag screw 2 provided at the intermediate portion is inserted.

  The insertion hole 21 may be fitted with a bushing (not shown) having the same material and knitting structure as the cross netting tube 11 and the cross knitting tube 16. The cavity of the portion of the nail 4 is closed, and the rigidity of the nail can be increased by the blocking. The shaft support of the lag screw 2 is also made on a support surface with high torsional rigidity, realizing a smooth and reliable operation and enhancing the stability.

  The cross netting tube 11 of the nail 4 and the lag screw 2 is cross-knitted with the UD tape 10 impregnated with PEEK resin in the roving bundle already described in detail above, and is heated and pressed into a cylindrical shape, and then cooled and solidified. It was. Instead, as a cross-knit tube 17 (see FIG. 8) in which PEEK resin is impregnated into a tube in which a UD tape 16 forming a roving bundle is cross-knitted, impregnated with PEEK resin, and then cooled and solidified. Also good.

  Incidentally, when the cross knitted tube 17 is formed by impregnating PEEK resin into a tube knitted with a UD tape 16 forming a roving bundle band so as to form a hollow pipe shape, The PEEK resin film (not shown) may be applied only on the outer surface or on the inner and outer surfaces, and the PEEK resin may be impregnated by heating and pressurization. If such a cross-knitted tube 17 is used, a tube formed by cross-knitting a UD tape 16 forming a roving bundle can be formed into a hollow pipe shape. That is, it is possible to suppress the increase in the gamma nail apparatus by using a commercially available carbon fiber tube.

  By the way, when repairing a fracture part with a gamma type nail, the fractured bone head is connected to the femur by screwing the nail into the cancellous bone inside the bone head. In that case, the screwed part is the cancellous bone inside the bone head. Since this part has extremely low bone density and low strength, the nail may not work effectively. Therefore, it is necessary to improve the bone strength around the threaded portion of the nail and lag screw. If the bone growth stimulant can be leached to the periphery of the nail or lag screw to increase the bone density, the therapeutic effect can be dramatically improved. In particular, it is said that the gait function after surgery is reduced in about half of patients with hip fractures in the elderly, aiming for early bone fusion with an osteogenesis promoter, avoiding post-operative muscle atrophy with a muscle atrophy prevention drug, etc. Combining with drugs will solve these problems.

  Therefore, as shown in FIG. 8 (a), a small hole 26 extending from the outer layer of the nail 4 to the internal cavity is opened, and a drug 28 contained in the internal cavity 27 (a biodegradable carrier is used to prevent bone growth stimulating agents and infections). It is expected that an antibiotic for use) will be provided with a medicinal function that allows the cancellous bone 29 to exude and release more than one month from the nail surface. A small hole 31 extending from the outer layer of the lag screw 2 to the internal cavity 30 is opened, and a drug carrying function capable of leaching and releasing the drug contained in the internal cavity can be provided. It can promote bone quality and promote resuscitation and accelerate postoperative recovery.

  This is because the high-performance composite material utilizes the feature that fatigue strength hardly decreases even when stress is concentrated in a small hole or the like. Moreover, it is stable without corrosion and hydrolysis, and has very high durability.

  It is possible to form a medicinal support structure that can effectively and continuously infiltrate the nail 4 and screw / bone joint surface, and to form a cylindrical medicinal support part for storage. can do. It can also be seen that the FRP gamma-type nail device is a type of fixing device in which a hollow rod is inserted into the bone marrow cavity and the fractured bone head is fixed with a screw, so that it is suitable for incorporating a medicinal structure. In a metal gamma-type nail device, fatigue strength decreases when a small hole through which a drug leaches is formed. However, since there is no problem in fatigue strength of a composite material, it is necessary to make a drug-supporting structure.

  In the above description, the application to the gamma-type nail device for the femur has been mainly described. However, the gamma-type nail device for the humerus 32 and the locking screw system for fixing the pelvis shown in FIG. It can also be applied to.

  DESCRIPTION OF SYMBOLS 1 ... Bone head, 2 ... Lag screw, 3 ... Bone marrow cavity, 4 ... Nail, 5 ... Side screw, 6 ... End cap, 7 ... Femur, 8 ... Hole, 10 ... UD tape, 11 ... Cross braided tube, DESCRIPTION OF SYMBOLS 12 ... UD tape, 13A, 13B ... Inner shell of upper and lower semicircular cross section, 14 ... UD tape, 15A, 15B ... Outer shell of right and left semicircular cross sections, 16 ... UD tape, 17 ... Cross knitted tube, 18 ... UD tape, 19 ... Cover with half-circular cross section, 21 ... Insertion hole, 22 ... UD tape, 23 ... Stainless steel wire, 26 ... Small hole, 27 ... Nail cavity, 28 ... medicine, 29 ... cancellous bone, 30 ... lag screw cavity, 31 ... small hole, 32 ... humerus.

Claims (14)

In the gamma type nail that pulls and fixes the head of the bone that is likely to fall off or dropped to the nail embedded in the bone marrow cavity by screwing the lag screw, so that the removal of the nail is prevented by the lateral screw,
A lug screw that forms a γ shape with the nail by being inserted obliquely upward from an intermediate portion of the nail made of PEEK resin carbon fiber composite material, the transverse screw that penetrates the distal portion of the nail substantially horizontally, Furthermore, the end cap screwed into the proximal part of the nail is also made of PEEK resin carbon fiber composite material,
The above-mentioned nail and lag screw are made by impregnating PEEK resin into a tube in which a UD tape forming a roving bundle band is cross-knitted, and then cooling and solidifying by heating and pressurizing into a cylindrical shape, or PEEK resin in a roving bundle band Cross-knitted UD tape impregnated with, and heated and pressed into a cylindrical shape and then cooled and solidified, and the UD tape is 0 degrees with respect to the tube axis direction to cover the tube cylinder surface. The inner shell of the upper and lower semicircular cross sections laminated at 90 °, 45 °, and −45 ° orientation and solidified after heating and pressurization, and the entire inner shell are 90 ° from the mating portion. After cross-orientation lamination of UD tape to cover it in a shifted manner, it comprises right and left outer shells that are solidified after heating and pressurization,
The transverse screw includes a cross knitted tube in which PEEK resin is impregnated into a tube in which a UD tape forming a roving bundle is cross-knitted, and a UD tape oriented and laminated in the tube axial direction to cover the cross-knitted tube cylindrical surface,・ Has a half-circular cross-section covering solidified after pressurization,
With the round bar-shaped core inserted in the tube, the upper and lower inner shells, the right and left outer shells are combined and placed in an injection mold, and molten PEEK mixed with fiber chips. The resin compound is press-fitted to form the surface layer and shell, and the resin in the combination is remelted by melting the compound, and the parts forming the thread and the molding of each tip of the molded product are melted. A gamma-type nail device, which is made of a compound and has a hollow body formed by removing any of the cores after the mold is opened.   When the cross knitted tube is formed by impregnating PEEK resin into a tube obtained by cross knitting a UD tape forming a roving bundle band so as to form a hollow pipe shape, the outer surface or the inner surface of the carbon tube formed by cross knitting only carbon fibers. 2. The gamma nail device according to claim 1, wherein a PEEK resin film is applied to the outer surface and impregnated with PEEK resin by heating and pressurization.   When the cross netting tube is formed by cross-knitting a UD tape impregnated with PEEK resin in a roving bundle, the PEUD resin-impregnated UD tape heated to form a hollow pipe by a triaxial braiding method The gamma-type nail device according to claim 1, wherein the gamma-type nail device is a three-axis network assembly.   The triaxial braiding of the roving bundle band is a method of forming a reticulated winding layer by a UD tape oriented so as to intersect with each other by being inclined and reversely inclined in the longitudinal direction. Gamma type nail device.   4. The gamma nail device according to claim 3, wherein the EK tape impregnated with PEEK resin is reticulated and wound through a forming head for heating.   The lag screw consists of a screw part that is screwed to the cancellous bone in the bone head and a journal part that is pivotally supported at the middle part of the nail, and a wrench engaging part for screwing the lag screw is formed at the opposite end of the screw The gamma nail device according to claim 1, wherein the gamma nail device is provided.   The hole through which the lag screw provided in the intermediate part of the nail is inserted is formed by drilling after molding of a molded product in which the core is removed to form a hollow body. The gamma-type nail device described in 1.   7. A bushing having the same knitting structure as that of the cross netting tube or the cross knitting tube is fitted into a hole through which the lag screw provided at an intermediate portion of the nail is inserted. Gamma-type nail device.   The lamination of the UD tape material in the inner shell body, the outer shell body, and the covering body is different in any one of claims 1 to 8, wherein the number of plies is different depending on a nail portion. Gamma type nail device.   The gamma nail device according to claim 9, wherein a UD tape extending in a longitudinal direction is also mixed with the mesh winding layer.   The gamma nail device according to claim 9, wherein a stainless steel wire extending in a longitudinal direction is laid on the mesh winding layer.   The end cap is formed by a molding die for injecting a molten compound independently of the nail or lag screw, and the male screw formed at the end cap end is solid. The gamma nail device according to claim 11.   A small hole extending from the outer layer of the nail to the internal cavity is opened, and a drug-carrying function is provided so that the drug contained in the internal cavity can be exuded and gradually released from the surface of the nail, particularly into the cancellous bone. A gamma nail device according to any one of claims 1 to 12.   A small hole extending from the outer layer of the lag screw to the internal cavity is opened, and a drug-carrying function is provided so that the drug contained in the internal cavity can be exuded and gradually released from the surface of the lag screw, particularly into the cancellous bone. 13. A gamma nail device according to any one of claims 1 to 12, characterized in that it is characterized in that: