WO2001052773A1

WO2001052773A1 - Ligament reinforcing material

Info

Publication number: WO2001052773A1
Application number: PCT/JP2001/000273
Authority: WO
Inventors: Tomoaki Koseki
Original assignee: Matsuda Medical Co.,Ltd.
Priority date: 2000-01-17
Filing date: 2001-01-17
Publication date: 2001-07-26
Also published as: JP2001198147A

Abstract

A ligament reinforcing material, wherein three components, annular, linear and branch portions (linear portions and annular portion), are each braded using a braid production gadget or joined to the linear portions by using soft metal, or a sheet is used to elaborately fix the end, thereby this material supplements the strength of the self-tissue, is simple and convenient, provides stabilized results, has a stretch elongation agreeing with the human tissue, allows the fixing of the cut end at an optional position, and reduces the volume of the fixing material to be embedded in the human body. The mounting of an end plate, end screw or end stopper in the ligament reinforcing material shortens operation hours, reduces residual wounds, and reduces bone tunnel volume. A human body reinforcing material having a rotary body attached thereto to protect the self-tissue from damage.

Description

Description Ligament reinforcement Technical field

The present invention relates to a ligament reinforcing material to be attached to supplement the strength of a substitute autologous tissue during ligament reconstruction surgery. Conventional technology

In order to reconstruct the damaged anterior cruciate ligament (ligament connecting the femur and tibia), in general, a substitute autologous tissue such as semiten (hemistenoid tendon) or gracilus (thin muscle) is collected and sewn in a ring. After pulling the loop in two directions with two tapes (17) or an artificial object such as a string, and passing through the bone tunnel, one end is attached to the femur using the end button (16), and the other end. Are fixed to the tibia surface using staples or the like.

In surgery to repair and reconstruct the medial patellofemoral ligament (ligament that connects the patella and femur), a hole is drilled through the patella from two directions in the upper and lateral directions, an artificial ligament (tape-like band) is passed through, and tape is attached with a staple etc. Is fixed to the femur so that it is sandwiched from above. Problems to be solved by the invention

The anterior cruciate ligament is a heavy part of the human body, but if you try to replace it all with a substitute for humans, it is strong enough but has poor affinity for bone, and it is too strong for bone. There were problems such as sharpening the corner.

At present, the hybrid method (the method of fixing both ends of the above-mentioned autologous tissue to the bone with a tape) is the mainstream, but the above problem is solved, but the autologous tissue in the central portion is sewn in a ring, which is complicated and complicated. It hinders surgery within a limited time that is performed by interrupting blood circulation to the lower limbs. In addition, since the area of the sewn portion is large, the result is greatly affected by the technique of the operator, and problems such as insufficient strength and insufficient blood circulation due to excessive sewing are also occurring.

Since the end button (16) for fixing the tape to the femur has a single-plate shape, when reaching the bone surface, the end button (16) may pinch soft tissue, which causes tissue necrosis. At the same time, when the _c- tape is fixed to the tibia, which is likely to leave a wound on the thigh to try to pull it out from the femur, the current method is to drive the staple into the tape so that it is inserted into the tape. Because of the heavy burden, you have to use a step with a large volume to be buried in the body. A large amount of foreign body buried in the body may cause pain and infection. Reconstruction of the medial patellofemoral ligament has the same problem because the tape is fixed to the femur so that the tape is sandwiched from above with a stable or the like. Means for solving the problem

The ligament reinforcement is considered as a three-part structure consisting of both ends connected to the central part, and the strength is secured by sewing the self-organized tissue (13) to the central part to the extent that it does not come off in a ring shape, making it easier and more stable. Surgery can be performed.

Since the central part of the ligament reinforcement is interlocked with the self-made yarn (13), the tensile elongation is preferably equal to the self-organized structure. In addition, it is desirable that both ends are stably fixed to the inner wall surface in the bone tunnel, and ideally the tensile elongation is set to a value close to zero.

The rear end of the ligament reinforcing material that is branched into a plurality of holes is formed with holes for driving staples, etc., and is passed through the legs of fixing material, such as staples, so that the tape can be inserted and fixed. There is no slippage that occurs and the fixing force is greater. As a result, the volume of the fixing material embedded in the body can be reduced. In addition, the conventional surgeon had no U-shaped stapling power or choice as a material for fixing the stump, but it became possible to select a screw or nail depending on the situation.

The end button (16) has the shape of a single plate, so that it is large when it comes out on the bone surface. Lowering and easy to pinch soft tissue. When passing through the bone tunnel, it is in a closed state. When the end plate (15) that expands when it reaches the bone surface and a ligament reinforcing material insertion device with end plates are used, the soft tissue can be sandwiched. can avoid. In addition, since incision from the side of the femur is unnecessary, residual wounds can be reduced.

Use of the end screw (2 1) requires time to rotate, but the fixation force is stable, and there is no need to open the bone tunnel on the femur side to the surface. It is needless to mention again that a smaller bone tunnel volume is preferable in terms of securing bone strength and histology. The hollow structure also promotes bone tissue induction.

The end stopper (24) can be fixed at any position in the bone tunnel. After inserting, if you pull it a little, the sharp protrusions at both ends will be pierced on both sides of the tunnel and fixed. The fixing force is increased by changing the insertion direction of the projections and mounting multiple pieces. In addition, since it is only an insertion operation, the operation time can be greatly reduced.

When one of the end plate (15), the end screw (21), and the end stop (24) is fixed to both the femoral and tibia bone tunnels, the knee center (drill insertion part) ), And the remaining wound is further reduced. In recent years, minimally invasive treatment has been called for, but since ligament injuries are more prevalent in young people, it is also a gospel, especially for young women who should not leave large surgical scars.

By attaching the seat (26), fixing materials such as stables, screws, and nails can be driven into any position. Avoiding tissue necrosis by compression by avoiding direct contact between bone and metal. Embodiment of the Invention

Hereinafter, embodiments of the present invention will be described with reference to the drawings. FIG. 1 illustrates an external view of a ligament reinforcing material according to claims 1 and 2. One straight string (2) is connected to one end of the loop (1), and the end is branched into two branches. Holes (7) for driving a stapler, screw or nail into each of the branched strings. , 8, 9, 10) in succession Has been established. If the inner periphery of the hole is reinforced with eyelets or the like, the hole will be formed even when pulled, and it will also protect the fibers when driving a step, screw or nail. For reinforcement of eyelets or the like, a metallic material such as SUS316L stainless steel or pure titanium having high biocompatibility is preferable. Sew the autologous tissue (13) in a loop so that it passes through the loop and the fork. Self-organizing structure The torsional anti-twisting material (11, 12) is applied to the bifurcated part from the ring (1) where both ends contact and the bifurcation part at the rear end. To prevent damage. It is recommended that the torsion-prevention reinforcing material be made of metal such as SUS316L stainless steel or pure titanium and be rounded so as not to have burrs. Alternatively, sewn a material with high biocompatibility and high surface smoothness, such as EPTFE (expanded polytetrafluoroethylene), can prevent damage to autologous tissue due to friction.

The tensile elongation increases when the fiber is knitted with a large amount of clogging in the longitudinal direction, and conversely, when the yarn is loosely knitted and the warp is close to a straight line, the tensile elongation decreases. Applying this principle, the tensile elongation of the central straight part is equal to that of the own tissue, and the tensile elongation of the ring (1) at one end and the branched linear parts (3, 4, 5, 6) at the other end is zero. It can be set to a value close to. The material is preferably high in strength and biocompatibility, and polyester, polyethylene or EPTFE (expanded polytetrafluoroethylene) which is a fiber is preferred. In particular, polyethylene and EPTFE have high strength and low elongation and are suitable for the material as a ligament reinforcing material of the present invention.

The diagram on the right side of FIG. 1 according to claim 2 shows a case in which a portion below the branch portion is made of a flexible metal (14). For connection with the straight string (2), attach a horizontal bar inside the central part of the tube, and pass the lower end of the small string-shaped straight string (2). In order to maintain the strength, it is better not to weld this bar but to cut it out from a cylinder. The left and right branches are formed with two continuous holes for driving a stable, screw or nail in the same way as the left figure. The thickness of this part is set so that it can be easily deformed by the surgeon's hand. Thereby, it can be fixed corresponding to the inclination and curvature on the tibia surface. 5 Suitable material is soft stainless steel or pure titanium. Since it is made of metal, its tensile elongation is close to zero.

Fig. 2 is an external view and a sectional view of the end plate (15) according to claim 3 when it passes through the bone tunnel and on the surface of the femur (when it reaches the femur). Fits into the width of the cartilage tunnel The back of the two-leaf metal piece is hemispherically recessed so that the tip (1 9) of the ligament reinforcement inserter with end plate fits. For this purpose, titanium 6/4 alloy is preferred, and for stainless steel, SUS316L is suitable.

FIG. 3 is an external view and a cross-sectional view when the end button (16) passes through the bone tunnel and reaches the surface of the femur. In the bone tunnel, it is oriented vertically, and when it comes out to the surface of the femur, it is operated so that it is horizontal. An incision must be made on the side of the femur so that it can be pulled up and placed from the side of the femur. Also, after pulling up, it is easy to pinch the soft tissue when pulling down.

FIG. 4 illustrates an external view of a ligament reinforcing material insertion device with an end plate according to claim 4. The tip has a protrusion (19) that pushes up the lower part of the end plate, and the hand has a protrusion (20) that inserts into a hole for driving a stable, screwed or nailed branch of ligament reinforcing material. Have. Furthermore, this projection slides back and forth, and acts to open the end plate (15) with the panel. The movement of the slide of the projection makes it possible to confirm that the end plate has reached the surface of the femur.

The left part of FIG. 5 is an example of a ligament reinforcing material with an end screw (21) according to claim 5. The inside of the column is hollow and the outside is threaded. The outer diameter is designed equal to the inner diameter of the bone tunnel. There are two notches at the bottom of the thread so that they can be turned with a special screwdriver. A rod is passed across the lower part of the hollow inside, and the connection is made by straddling the ligament reinforcing material according to claim 1 or 2.

The right side of FIG. 5 illustrates a ligament reinforcing material with an end screw (21) having an insertion portion with a pipe-shaped rotating body (23) according to claim 7. Sew autologous tissue to metal instead of fiber P01 / 0 273

In this case, the strength is high and there is no risk of twisting, but the knee tissue may rub against the metal surface due to flexion and extension of the knee, and the fibrous material may be destroyed, causing a risk of tearing. A rotating body (2 3) is wrapped around a central cylindrical horizontal bar (2 2) made of a machined 6-4 titanium alloy formed in a ladder shape and sewn. A self-organization (1 3) is straddled on this. The autologous tissue is pulled around the central columnar bar (2 2) as the knee flexes and stretches, but the rotating body (2 3) rotates and rotates in conjunction with this, and the autologous tissue (1 3) is brought into contact with the metal surface. Avoid direct rubbing. Wrapping the rotating body not only on the central horizontal bar (2 2) but also on the adjacent upper and lower vertical bars allows for complicated knee movements. The most suitable material for the rotating body is EPTFE (expanded polytetrafluoroethylene), which has high biocompatibility, antithrombotic properties, pressure resistance, abrasion resistance, and moderate cushioning properties. The whole is turned with a special screwdriver and fixed in the tunnel.

FIG. 6 shows an example of a ligament reinforcing material provided with an end stopper (24) having an insertion portion with a pipe-shaped rotating body (23) according to claims 6 and 7. The upper end of the vertically long ring-shaped flat plate has a sharp beak-like projection, and the lower end has a tail-like sharp projection with the tip directed in the opposite direction to the upper end. Use two of them, back to back, and pass through the inverted U-shaped shaft. The hole in the ring has a slight bulge on the lower end opposite the tail. When pushing up the entire ligament reinforcement to the femur side, the inverted U-shaped shaft is located at the corner of the ring hole on the beak-shaped side, and in this state, the tail-shaped protrusion at the lower end is slightly It only contacts the bone tunnel wall. Conversely, when trying to pull down the entire ligament-strengthening material toward the tibia, the inverted U-shaped shaft enters the bulged portion at the lower end of the ring hole, so the caudal protrusion is pushed by this to the wall of the bone tunnel. Insert. At the same time, the upper beak side falls down into the wall of the opposite bone tunnel and penetrates. The other piece of the back-to-back movement works in the opposite direction, and the deeper the force, the deeper the four protrusions penetrate the bone tunnel.

FIG. 7 illustrates an external view of a braid manufacturing device according to claim 10. First, the weight is hung down from the center hole and connected to the thread bundle. Before installing the end plate, end screw, end stopper, etc. Keep it. When manufacturing the ligament reinforcing material according to claim 1, the bone tunnel insert is formed into a ring (1) without braiding, and then the center straight portion (2) is started to be assembled. Adjust the number of eyes in this part so that it has the same tensile elongation as the anterior cruciate ligament. If the cross section of the round eights is circular, it will be easier to pass through the bone tunnel. Next, at the branching point, do not bundle the yarn bundle again and leave a little space in the straight state (3, 4, 5, 6). The holes (7, 8, 9, 10) into which the staples, screws or nails are driven are formed in a ring with a flat eight or the like. Behind the loops a little tail-shaped to prevent fraying. The parts that remain straight (1, 3, 4, 5, 6) without forming a bundle of yarn are coated with honey, etc., and are kept intact. When manufacturing the ligament reinforcement according to claim 2, after assembling the central straight portion (2), assembling is performed while passing a small ring for metal connection through the metal rod. Behind the loop is a tail, as described above. In the case of manufacturing a ligament reinforcing material having a rotating bone tunnel insertion part according to claims 7 and 8, small loops for metal connection are formed at both ends of the central straight line (2) and assembled while passing through a metal rod. The back of the wheel is tail-shaped as before. When welded at the rear end with an ultrasonic power cutter, it finishes neatly without fraying.

Figure 8 shows a mushroom-shaped endplate for drilling holes attached to a bone tunnel. In the middle of the bone tunnel, the two-leaf plate is closed. When reaching the top of the bone tunnel, pulling the lever (2 9), the push-up rod (2 5) is pushed by the tip (30) of the special instrument inserted from the extrusion hole (28), and the two-leaf plate is be opened. The lower end of FIG. 8 is a view attached with a soft sheet (26) for driving a fixing tool such as a stable according to claim 9. The end of the sheet passed through the metal ring is widened so that a stable or the like can be hit at any position. By setting the width larger than the stable width, it is possible to prevent the stepping from slipping through the gap. When divided into left and right, and spread and hit, it can cope with pulling from all directions and increase the fixing force. If one is temporarily fixed and the other is fully fixed while pulling, the tension of the ligament can be confirmed by the feel of the hand. Even if the staples are pulled down by strong tension and the staples fall down, the seat becomes a cushion, preventing tissue necrosis due to compression. The material is highly biocompatible and has high strength and moderate cushioning EPTFE is suitable.

FIG. 9 illustrates the insertion device of the mushroom-type end hole for a drill hole shown in FIG. It has a bifurcated arm that wraps around the lower end (27) at the tip, and a member (30) for pushing up the push-up rod (25) from inside is provided. The member (30) is pushed out by pulling the lever (29), and the end of the two leaves of the end plate is opened.

FIG. 10 is an overall view of the operation. The upper part is the femur, the lower part is the tibia, and the middle part is the anterior cruciate ligament. If the sewn autologous tissue is gradually inserted into both the femur and tibia, osseointegration is likely to occur. The invention's effect

In the ligament reinforcing material of the present invention, the strength of the autologous tissue is ensured according to claims 1 and 2, and the operation can be performed more easily and with stable results. In addition, it provides tensile elongation that matches the body tissue, and stabilizes the fixation of autogenous tissue and bone. Adoption of the branched tibial side driving portion or the soft sheet described in claim 9 allows the ligament reinforcing material stump to be fixed at a position that was difficult to fix conventionally, such as a curved portion, and maintains strength against loads from all directions It is possible to do this. It also prevents compression tissue necrosis due to direct metal contact.

The lower end of the ligament reinforcing material is formed in an annular shape, or the adoption of the soft sheet according to the ninth aspect enables the use of various fasteners such as staples, nails, and screws at the discretion of the operator. In addition, since the fixing force is higher than when the tape is sandwiched, the volume of the part buried in the body can be reduced.

Since the third aspect incision from Endobotan _c The femoral avoid pinching of soft tissue due to the femoral side is unnecessary can be kept small residual wound. According to claim 4, the ligament reinforcing material with the end plate can be easily inserted into the bone tunnel. _{C According to} claims 3, 5, and 6, fixation in the middle of the bone tunnel becomes possible, and the volume of the bone tunnel can be reduced. Furthermore, claim 6 makes it possible to significantly reduce the operation time. According to claim 7, the self-tissue rubs against the metal surface due to the flexion and extension of the knee, and the fibrous material is prevented from being broken and broken.

According to claim 8, an incision is made only in the central part of the knee (drill insertion part), and the residual wound is further reduced.

According to the tenth aspect, it is possible to manufacture a string portion of the ligament reinforcing material having the above characteristics. BRIEF DESCRIPTION OF THE FIGURES

Figure 1 is an external view of a ligament reinforcement and a ligament reinforcement sewn with its own tissue. FIG. 2 is an external view and a cross-sectional view of the end plate.

FIG. 3 is an external view and a cross-sectional view of the end button.

Figure 4 is an external view of the ligament reinforcement set in the ligament reinforcement insertion device with endplate.

Figure 5 is an external view of a ligament reinforcement with an end screw.

FIG. 6 is an external view of a ligament reinforcement with an end stopper.

FIG. 7 is an external view of a braid manufacturing device.

FIG. 8 is a cross-sectional view of a mushroom-type end hole for a drill hole, and an external view with a soft sheet for driving a fixing tool.

Figure 9 shows a mushroom-type end plate insertion tool for drill holes.

FIG. 10 is an overall view of the operation. Explanation of reference numerals

One wheel

2 Straight string

3, 4, 5, 6 branched straight section

7, 8, 9, 10 holes 1 1, 1 2 Reinforcement

1 3 Self-organization

1 Flexible metal

1 5 Endos Topper

1 6 End button

1 7 tape

1 8 Pull cord

1 9 Push-up protrusion

20 protrusion to be inserted into the hole

21 Ends Cryut

22 Central cylindrical bar

23 rotating body

24 End Stopper

25 push-up bar

26 Soft seat for hammering fixture 27 Overall lower edge

28 Extruded hole

29 lever

30 Parts to extrude

Claims

Scope of Claim Claim 1. A string to be attached to supplement the strength of the autologous tissue substitute during ligament reconstruction surgery. One straight string (2) is connected to one end of the ring (1). The trailing end is branched into multiple parts, and a step (a U-shaped nail), a screw (a screw) or a nail is attached to each of the branched straight strings (3, 4, 5, 6). One or more holes (7, 8, 9, 10) for driving are continuously formed at regular intervals, and the inner periphery of the holes is reinforced with eyelets, etc. Each branch at the rear end is provided with a torsion-preventing reinforcing material (11, 12), and the tensile elongation of the central straight line is set to be the same as that of the in-house tissue (13). A ligament reinforcing material with the tensile elongation of the ring at one end (1) and the branched straight part (3, 4, 5, 6) at the other end set to a value as close to zero as possible.

Claim 2. The ligament reinforcing material is formed with straight portions (3, 4, 5, 6) after branching and holes (7, 8, 9, 10) for driving staples, screws or nails. The ligament reinforcement according to claim 1, wherein the portion of the ligament is made of a flexible metal (14).

Claim 3. With the ligament reinforcing material, the two-leaf metal pieces are closed in the bone tunnel, and the two-leaf metal pieces are opened in the middle of the bone tunnel or at the time of reaching the bone surface. The ligament reinforcement according to claim 1 or 2, wherein an end plate (15) having a structure that does not return is attached to the ring (1) at one end.

Claim 4. When inserting the ligament reinforcement with the end plate into the bone tunnel, the end plate is kept closed in the bone tunnel, and the tip is opened so that the end plate opens when it reaches the bone surface. It has a protrusion (19) that pushes up the lower part of the end plate, and a protrusion (20) that is inserted into a hole (7, 8, 9, 10) for driving a staple or nail of a branched string of the ligament reinforcement on the hand side. A ligament-capturing material insertion device with an endplate that slides back and forth with this projection and acts to open the endplate with the panel.

Claim 5. The ligament reinforcing material, wherein the screw has the same outer diameter as the bone tunnel lumen, and has a hollow structure. The ligament reinforcing material according to claim 1 or 2, wherein the end screw (2 1) is mounted on a ring at one end.

Claim 6. The ligament reinforcing material has sharp projections at both ends of the vertically elongated ring-shaped flat plate for penetrating the surface of the bone tunnel, and when a force is applied so that the ring hole is pulled back in the bone tunnel, the projection at one end becomes bone. An end stopper (24) having a structure of sticking to the surface, falling down so that the whole is in a parallel direction, inserting a protrusion at the other end to the opposite side, and not returning in the opposite direction, is attached to the ring at one end. The ligament-strengthening material described in 2.

Claim 7. The bone ligament reinforcing material according to claim 3, 5 or 6, wherein a bone-shaped tunnel-inserted portion is provided with a pipe-shaped rotating body (23) attached to both ends of the autologous tissue sewn in an annular shape. Ligament reinforcement.

Claim 8. The above-mentioned ligament reinforcing material is provided with a bone tunnel insertion part to which the pipe-shaped rotating body (23) according to claim 7 is attached at both ends of the central straight string part (2). A ligament reinforcement having one end plate (15), one end screw (21) or one end stop (24) connected to its end.

Claim 9. The ligament reinforcing material has a structure in which a soft sheet (26) for driving a fixing tool such as a staple or the like with a metal loop or the like can be attached to a stump of one end of the central straight string portion (2). 9. The ligament reinforcing material according to claim 8, having a ligament reinforcing material.

Claim 10 0. Using the braid manufacturing device, the ligament reinforcement material loop (1) is joined in a state close to a straight line without weaving, and the center straight string portion (2) is formed in a circular cross section. The braided and branched straight sections (3, 4, 5, 6) are not braided, and the holes (7, 8, 9, 10) for driving staples, screws or nails are braided annularly. The method for producing a string portion of a ligament reinforcing material according to claim 1, 2, 3, 5, 6, 7, 8, or 9, which is formed.