JP5283377B2 - Ligament or tendon anchor, graft ligament set using the same, and ligament transplantation method using the same - Google Patents

Description

  The present invention relates to an anchor for fixing a ligament or a tendon, a transplant ligament set using the anchor, and a ligament transplant method using the anchor.

Illustrated Knee Clinic (Edited by Keisuke Fujita, pages 14-15 published by Medical View, April 1999) Knee sports injuries (Edited by Nei Fumino, 1995, published by the School of Medicine, 188-191) International Publication No. WO2006 / 033455A1

  Non-Patent Document 1 discloses primary repair using a semi-tendon-like tendon pedicle graft as shown in FIG. 6 as a surgical treatment of an anterior cruciate ligament. In this repair, drill holes 103 and 104 are drilled in the femur 101 and the tibia 102, respectively, and the reconstructed ligament 105 constituted by bundling various tendon tissues of the person is penetrated through the drill holes, and the end portion that has come out Is fixed to the bone surface with a fixing member such as a screw 106 and a spiked washer 107. Reference numeral 108 denotes a fractured end of the damaged anterior cruciate ligament.

  Further, in Non-Patent Document 1, depending on the type of ligament or tendon to be transplanted, autotransplantation, allogeneic transplantation (using tendons at different sites such as Achilles tendon), xenotransplantation (using bovine tendons treated with glutaraldehyde, etc.) In addition, the use of artificial ligaments (constructed by bundling synthetic fibers, carbon fibers, etc.) is also disclosed. Non-Patent Document 2 discloses a method similar to the ligament surgical therapy of Patent Document 1.

  Further, a method of transplanting the knee cruciate ligament as shown in FIG. 7 is known. In this method, first, a support hole 109 is formed with a drill or the like so as to cross the tendon tissue in the femur 101, and the support rod 110 is inserted into the support hole 109. Next, drill holes 103 and 104 for inserting the reconstructed ligament 111 into the femur 101 and the tibia 102 are drilled. Thereafter, one end of the reconstructed ligament 111 in which the various tendon tissues of the user are bundled is inserted from the drill hole 103 of the femur 101, and the reconstructed ligament 111 is folded back and fixed by the support rod 110 (clothes for drying clothes). Then, the other end of the reconstructed ligament 111 is inserted into the drill hole 104 of the tibia 102 and penetrated, and fixed to the surface of the tibia 102 with a fixing tool such as a screw 106 and a spiked washer 107.

  On the other hand, FIG. 3 of Patent Document 1 discloses a scaffold material used for artificial tooth roots and artificial joints composed of a cylindrical titanium rod and a metal fiber layer having an average pore size of 100 to 400 μm provided on the inner and outer surfaces thereof. Has been. Titanium fiber is used as the metal fiber layer.

  Non-patent documents 1, 2 and the anchor used to fix the ligament to the bone used in the method of FIG. 7 are a screw 106 or a stapler screwed into the outer surface of the bone, and a semi-tendon-like shape through a drill hole formed in the bone Since the muscle tendon is pulled and fixed, a high level of skill is required. Moreover, it can be used only when the bone strength is sufficient.

  On the other hand, the scaffold material of Patent Document 1 has an excellent effect on the connection between the alveolar bone and joint bone and the surrounding tissue. An object of the present invention is to provide an anchor that can be used for ligament transplantation and the like by applying the technique of Patent Document 1 and that can easily perform a firm bond between a bone and a tendon. Furthermore, it is an object of the present invention to provide a graft ligament set and a ligament graft method using the anchor.

  The anchor of the present invention is an anchor that fixes a mammalian ligament or tendon to a bone, and includes a porous cylindrical body that is formed in a cylindrical shape by entanglement with a biocompatible metal fiber. It is a feature. In such an anchor, an average pore size of the porous cylindrical body is preferably 100 to 400 μm. The metal fibers are preferably titanium fibers having a diameter of 5 to 400 μm. Furthermore, an anchor impregnated with an undifferentiated mesenchymal cell (bone marrow fluid) collected from a living body or a dispersion obtained by treating a ligament fragment collected from a living body by enzymatic digestion is preferable. The ligament is preferably a knee cruciate ligament connecting the femur and tibia.

  The transplant ligament set of the present invention is a transplant ligament set for transplanting a ligament to a mammal (including a human), and includes a ligament-like string body and the anchors fixed to both ends of the ligament-like string body. It is characterized by becoming. In such a graft ligament set, the ligament-like string body is a ligament collected from a living body, and the end of the ligament is covered with the anchor and cultured to grow the ligament tissue to the inside of the anchor gap. Those are preferred. Further, the ligament-like string body is a ligament or tendon collected from a living body, and the anchor is a dispersion obtained by treating an undifferentiated mesenchymal cell (bone marrow fluid) collected from a living body or a ligament fragment collected from a living body by enzymatic digestion. A liquid impregnated with a ligament or tendon inserted into the anchor gap is preferred.

  The ligament transplantation method of the present invention is a method of transplanting a ligament to a mammal other than a human, wherein holes for embedding anchors are formed in advance in two bones to be connected by the ligament, and the above-mentioned holes are formed in the holes. It is characterized by embedding an anchor of a graft ligament set. This transplantation method can also be adopted for humans.

  In the anchor of the present invention, the tissue of the ligament or tendon to be transplanted is grown in the anchor, and the tissue is integrated and implanted in a hole formed in the bone connected to the ligament or tendon to be transplanted. As a result, the bone tissue penetrates into the anchor and is firmly joined. In this way, when the anchor of the present invention is employed, the bone and the ligament or tendon are firmly joined via the anchor, so there is no need to use a screw or a stapler. Moreover, even if it uses, it remains an auxiliary role. Therefore, surgery is easy and the success rate is high.

When the average pore size of the porous cylindrical body is 100 to 400 μm, ligaments or tendon or bone tissue can easily enter and be integrated. Further, when the metal fiber is a titanium fiber having a diameter of 5 to 400 μm, a porous cylindrical body having high strength and appropriate porosity can be obtained.
In addition, when impregnated with undifferentiated mesenchymal cells (bone marrow fluid) collected from a living body or a dispersion obtained by treating a fragment of a ligament collected from a living body by enzymatic digestion, the ligament or tendon inserted into the anchor and the anchor The bond formation period is short.

  When the ligament is a knee cruciate ligament connecting the femur and the tibia, it is required that the joint strength between the ligament and the bone is high, but the requirement can be sufficiently satisfied by using the anchor described above.

  In the graft ligament set of the present invention, since the anchor is fixed to both ends of the ligament-like string body to be transplanted, the ligament and the bone are surely integrated and the joint strength is high. Moreover, it is not necessary to use a screw or a stapler.

  When the ligament-like string body is a ligament or tendon collected from a living body, the end of the collected ligament or tendon is covered with the anchor and cultured outside the body to grow the ligament tissue into the anchor gap. Can be made. The obtained graft ligament set can be used for transplantation as it is. The ligament to be collected in this case may be the ligament or tendon of the living body itself (autograft), or may be the ligament or tendon of another mammal (transplant).

  Further, the ligament-like string body is a ligament or tendon collected from a living body, and the anchor treats undifferentiated mesenchymal cells (bone marrow fluid) collected from a living body or a ligament fragment collected from a living body by enzymatic digestion. When the ligament or tendon is inserted into the anchor gap, the bond formation period between the ligament or tendon inserted into the anchor and the anchor is short. Therefore, it may be used after being cultured in vitro, or may be bonded in vivo while temporarily fixing the anchor and the ligament or tendon.

  Since the ligament transplantation method of the present invention uses the aforementioned graft ligament set, the joint strength between the ligament and the bone is high, and the operation is relatively easy.

  Next, the anchor, graft ligament set, and patella ligament graft method of the present invention will be described with reference to the drawings. FIG. 1 is a perspective view showing an embodiment of the anchor of the present invention, FIG. 2 is a sectional view of the anchor, FIG. 3 is a perspective view showing an embodiment of a graft ligament set using the anchor, and FIG. FIG. 5a shows another graft ligament set using the anchor of FIG. 1, and FIG. 5b shows another embodiment of the ligament graft method using the ligament set. FIG. 5c shows another set of graft ligaments using the anchor of FIG.

  An anchor 10 shown in FIGS. 1 and 2 is an anchor that fixes a mammal's ligament or tendon to a bone. The anchor 10 is made of a porous cylindrical body that is formed in a cylindrical shape by entanglement with a biocompatible metal fiber 11. Become. The outer diameter D of the anchor 10 is preferably 8 to 16 mm, the inner diameter d is 4 to 12 mm, and the length L is preferably about 10 to 40 mm. The average pore size of the porous cylindrical body is preferably 100 to 400 μm. When the thickness is less than 100 μm, tendon and bone tissue are difficult to enter. On the other hand, when it exceeds 400 μm, the bond strength with bone tissue, ligament or tendon tissue is lowered.

  Titanium fibers are preferable as the metal fibers constituting the porous cylindrical body. Instead of titanium, titanium alloy, gold, gold alloy and the like can be used, and any metal having high biocompatibility and high strength such as stainless steel and cobalt-chromium alloy can be used. . The metal fiber preferably has a diameter of 5 to 400 μm. When the diameter is less than 5 μm, the strength is low and manufacturing becomes difficult, and when the diameter exceeds 400 μm, it becomes difficult to form a desired pore size.

  As the cross-sectional shape of the metal fiber, various cross-sectional shapes such as a circular shape, a rectangular shape such as a quadrangle and a hexagon, and a flat shape whose thickness is about 1/1 to 1/10 of the width can be adopted. . These may have a twisted shape. In order to form a cylindrical body, for example, a metal fiber is entangled around a core material having a diameter of 1 to 10 mm and wound to a thickness of about 10 μm to 3 mm, or a nonwoven fabric or a woven material having a thickness of 10 μm to 2 mm in advance. A web formed in the form of a cloth is wound and vacuum sintered. Thereby, the metal fibers in contact are welded and joined. The sintering temperature varies depending on the melting point (Tm · ° C.) of the metal wire, and is preferably about 0.3 to 0.9 times the melting point (Tm · ° C.) of the metal or metal alloy. When titanium fiber is used as the metal fiber, the melting point of titanium is 1668 ° C., and therefore the sintering temperature is preferably about 500 to 1500 ° C.

The obtained anchor 10 can be used as it is, but the surface may be coated with an inducing agent for inducing living cells. Examples of such inducers include hydroxyapatite containing carbonate apatite and other calcium phosphate compounds. As a result, a collaboration zone in which the bone tissue created by the osteoblast and the metal fiber layer of the anchor 10 are integrated can be achieved in a short period of time.
Alternatively, the anchor 10 may be impregnated in a dispersion obtained by treating an undifferentiated mesenchymal cell (bone marrow fluid) collected from a living body or a ligament fragment collected from a living body by enzymatic digestion. Thereby, the joint formation period of the ligament or tendon inserted in the space | gap of an anchor and an anchor can be shortened. In that case, the ligament or tendon may be temporarily fixed to the anchor and the ligament or tendon may be grown in vivo without culturing in vitro.

  In such an anchor 10, a tube made of a thin metal plate may be disposed on the outer surface or the inner surface of a cylindrical body of metal fiber, and the metal fiber and the tube may be integrated when vacuum sintering is performed. Thereby, a reinforcing effect is obtained and the strength is increased. In addition, it is preferable to form a large number of small holes in the tube so as not to prevent the entry of osteoblasts, ligaments or tendon cells.

  The graft ligament set 12 shown in FIG. 3 includes a ligament-like string body 13 and an anchor 10 that is integrally bonded to both ends of the ligament-like string body 13. The ligament-like string body 13 is used in place of a damaged ligament and has a thickness similar to that of a ligament to be transplanted by bundling tendon tissue collected from, for example, a patient to be transplanted or an Achilles tendon of a mammal other than a human. It is a thing. In addition, when transplanting to a human, another person's ligament can also be used, and the mammal's ligament or tendon similar in size to humans, such as a pig, can also be extract | collected and used. Furthermore, an artificial ligament obtained by bundling fibers made of an organic material such as a synthetic fiber having high strength and fibers made of an inorganic material such as carbon fiber and glass fiber into a ligament shape can be used.

  When used for transplantation of the cruciate ligament, the thickness of the ligament-like cord body 13 is preferably about 4 to 16 mm, and the length is preferably about 20 to 80 mm. In the case of mammals other than humans, such as cattle, pigs, horses and other livestock, dogs, cats and other pets, they are collected or prepared according to the thickness and length of their ligaments.

  In order to join the anchor 10 to both ends of the ligament-like string body 13 collected as described above, the end part of the ligament-like string body 13 is inserted into the hollow part of the anchor 10 and consists of an amino acid-containing cell culture basic solution. After culturing in the culture solution for about 1 to 3 weeks, the ligament tissue is infiltrated into the gap between the metal fibers of the anchor 10 and integrated. In the case of an artificial ligament, the anchor 10 is joined with a biocompatible adhesive such as cyanoacrylate.

  The graft ligament set 12 obtained as described above is transplanted so that the femur 15 and the tibia 16 are connected by the procedure shown in FIG. First, the graft ligament set 12 is created as described above (first step S1). Next, holes 17 and 18 for inserting the anchor 10 into the femur 15 and the tibia 16 are formed by a drill or the like (second step S2). The holes 17 and 18 are easier to form if they are through holes. However, the hole may be closed on one side, in which case the bone strength is not reduced. Subsequently, the anchors 10 and 10 of the graft ligament set 12 prepared as described above are inserted into the holes 17 and 18 and sutured. And it fixes with a wire steel wire etc. so that a knee joint may not move, and it cures for about 1-3 weeks (3rd step S3). Thereby, osteoblasts enter the anchor 10 from around the holes 17 and 18 and are integrated.

  As described above, in this ligament transplantation method, since the joint strength between the ligament-like string body 13 and the bone is high, it is not necessary to screw or drive a screw or stapler into the bone. However, a screw or a stapler can be used in combination as a reinforcing means.

  5a and 5b, another embodiment of a transplant ligament set and a ligament transplant method using the same will be described. First, a graft ligament set 21 including a ligament-like cord body 13, an anchor 10a integrally connected through one end thereof, and an anchor 10b integrally connected to the other end is prepared (see FIG. 5a). Next, a support hole 22 is formed in the femur 15 with a drill or the like so as to cross the tendon tissue, and a support bar 23 is inserted into the support hole 22. Further, holes 17 and 18 for inserting the graft ligament set 21 are drilled in the femur 15 and the tibia 16. At this time, the hole 17 of the femur 15 and the support hole 22 intersect.

  Here, one end 13a of the ligament-like string body of the graft ligament set 21, that is, a portion protruding from the anchor 10a of the ligament-like string body 13 is inserted through the hole 17 of the femur 15 and folded so as to be hooked on the support bar 23, Thereafter, the anchor 10 a is fixed in the hole 17. At this time, the one end 13 a may be fixed to the anchor 10 a or may be fixed to a part of the ligament-like string body 13. Finally, the anchor 10 b of the graft ligament set 21 is inserted into the hole 18 of the tibia 16.

  Moreover, as shown in FIG. 5c, a graft ligament set 21a including a ligament-like string body 13 and anchors 10a and 10b integrally penetrated through both ends thereof may be used. In this case, as shown by the imaginary line in FIG. 5b, the other end 13b of the band-like string body is passed through the hole 18 of the tibia and fixed with a fixture or the like. In this case, it can be fixed firmly although it takes time.

  In the above embodiment, the knee cruciate ligament transplantation method has been described, but other ligaments or tendons can be transplanted in the same manner. Moreover, although the case where it transplanted to the mammal or patient (human) which treats the ligament collected from the biological body (donor) was demonstrated in the said embodiment, the artificial ligament using the string body for ligaments comprised from the organic material or the inorganic material The same applies to. In the case of an artificial ligament, it is not necessary to culture, but it is preferable to bond the ligament string and the anchor with various bioadhesives to increase the bonding strength. Alternatively, the artificial ligament may be inserted through the anchor, and the tip of the artificial ligament may be temporarily fixed to the bone with a screw or the like that absorbs bone.

It is a perspective view which shows one Embodiment of the anchor of this invention. It is sectional drawing of the anchor of FIG. It is a perspective view which shows one Embodiment of the graft ligament set using the anchor of FIG. It is process explanatory drawing which shows one Embodiment of the ligament transplantation method using the anchor of FIG. Fig. 5a is another graft ligament set using the anchor of Fig. 1, Fig. 5b is an explanatory view showing another embodiment of a ligament transplantation method using the ligament set, and Fig. 5c is an illustration of the anchor of Fig. 1. It is the other transplant ligament set used. It is process drawing which shows an example of the conventional ligament transplantation method. It is process drawing which shows the other example of the conventional ligament transplantation method.

Explanation of symbols

10, 10a, 10b Anchor 11 Metal fiber 12 Implanted ligament set 13 Ligament-like string body 13a One end 13b of ligament-like string body 15 Other end of ligament-like string body 15 Femur 16 Tibia 17, 18 Hole 21, 21a Implanted ligament set 22 Support Hole 23 Support rod

Claims (4)

An anchor provided with a porous cylindrical body formed by intertwining metal fibers having biocompatibility, a ligament-like string body, and the anchor is fixed to the ligament-like string body, and the ligament-like string A transplant ligament set for transplanting the body to a mammal,
The anchor has a hollow portion provided as a through-hole in the axial direction of the cylindrical body, and the ligament-like string body has the end portion of the ligament-like string body extended from the anchor by a predetermined amount. Arranged in the hollow portion, the ligament-like string body is a ligament or tendon collected from a living body, and the tissue of the ligament or tendon is previously grown into the void of the anchor, and the anchor and the ligament-like string body are integrated. A graft ligament set, characterized in that it is bonded to the ligament. When the ligament-like string body is inserted into a hole formed in the bone, the end of the ligament-like string body can be fixed to the bone with a fixture, and is separated from the end of the ligament-like string body by a predetermined amount. The graft ligament set according to claim 1, wherein a predetermined amount is extended from the anchor so that the position can be fixed to the bone by the anchor.   The ligament-like string body is a ligament or tendon collected from a living body, and the anchor is an undifferentiated mesenchymal cell (bone marrow fluid) collected from a living body or a fragment obtained by treating a fragment of a ligament collected from a living body by enzymatic digestion The transplanted ligament set according to claim 1, which is impregnated with a liquid, and a ligament or tendon is inserted into a gap of an anchor.   A method for transplanting a ligament to a mammal other than a human, wherein holes for embedding an anchor are formed in advance in two bones to be connected by the ligament, and the anchor of the transplant ligament set according to claim 1 Embedding a ligament transplantation method.