WO2024099065A1

WO2024099065A1 - Bone implant, positioning sleeve, inserter, and implantation system

Info

Publication number: WO2024099065A1
Application number: PCT/CN2023/126177
Authority: WO
Inventors: 张凤羽; 葛立; 霍红亚; 王远强
Original assignee: 上海利格泰生物科技股份有限公司
Priority date: 2022-11-10
Filing date: 2023-10-24
Publication date: 2024-05-16
Also published as: CN115778457A

Abstract

Provided are a bone implant for fixing a soft tissue (4), a positioning sleeve (7), an inserter (6), and an implantation system. The bone implant comprises a first bone implant (1), a second bone implant (2), and a linking element (3). The first bone implant (1) comprises a first suture (102) and a first circular sheath (101), the first suture (102) passing through the first circular sheath (101). The second bone implant (2) comprises a second suture (202) and a second circular sheath (201), the second suture (202) passing through the second circular sheath (201). The first suture (102) forms a suture loop and then passes through the linking element (3) to be free outside the linking element (3). The second suture (202) forms a suture loop and then passes through the linking element (3) to be free outside the linking element (3). After the first bone implant (1) and the second bone implant (2) are each configured for a target object, the first circular sheath (101) and the second circular sheath (201) are deformed into flexible knots (1', 2'), respectively tightening the first suture (102) and the second suture (202), with the linking element (3) being fixed on the surfaces of the target objects. The two bone implants (1, 2) can be implanted into a bone (5) at the same time to fix the soft tissue (4), and the two bone implants (1, 2) are connected by using two linking elements (3), eliminating the need for knotting on the surface of the bone.

Description

Bone implant, positioning sleeve, inserter and implantation system

Technical Field

The present invention belongs to the technical field of medical devices, and in particular relates to a bone implant, a positioning sleeve, an inserter and an implantation system for soft tissue fixation.

Background technique

In recent years, the wire anchor technology made of titanium alloy, PEEK and polylactic acid materials has been widely used in the repair of injuries at the junction of soft tissue and bone tissue, such as: rotator cuff injury, labrum injury, proximal femoral tendon injury, anterior and posterior injuries of the labrum superior to the shoulder joint, reconstruction of ulnar collateral ligament injury, distal biceps tendon injury, scapholunate interosseous ligament repair, triangular fibrocartilage repair, extensor tendon injury repair, etc. This type of hard anchor is similar to a screw that is screwed onto the bone tissue near the part that needs to be fixed. The preloaded suture on the anchor passes through the soft tissue that needs to be repaired, and the soft tissue is fixed to the surface of the bone tissue by binding and tightening the suture to complete the physical repair of the damaged tissue.

With the increasing application of hard material anchor technology, hard material anchors are known to have many defects: titanium alloy metal anchors are prone to inflammation due to rejection reactions after implantation, causing bone dissolution at the implantation site, causing anchor loosening and displacement, resulting in fixation failure. PLA absorbable anchors may degrade and break prematurely after implantation, and secondary anchor displacement leads to reduced fixation firmness, and degradation products may cause synovitis, osteolysis and other problems. Although PEEK wire anchors solve the problems of easy loosening and displacement of titanium alloy anchors after implantation, and also solve the problems of rupture or premature degradation of absorbable material anchors after implantation, secondary displacement leads to reduced fixation firmness, and degradation products easily lead to synovitis, osteolysis and other problems, there are still problems such as large bone channels at the anchor implantation site, resulting in large bone removal, and prone to fractures or bone ruptures. In addition, once the hard material anchor is detached from the bone channel after implantation, the hard anchor will cause damage to the nearby joint tissue and bone surface; hard anchor repair is not only very difficult but also causes great pain to the patient.

In order to solve the problems of hard material anchors, full suture anchor products have emerged. The anchor part of this product is made of materials that can be used to make sutures. It has the following advantages: soft material anchors can change their shape at will, the bone channel required for fixation is small, and the amount of bone removed is small; it is easy to remove and repair, and the bone channel can be slightly enlarged during repair and replaced with hard material anchors; even if the soft material full suture anchor is removed from the bone channel after implantation, it will not cause damage to the surrounding joints and bone surfaces.

Whether it is a hard anchor or a soft anchor with a wire, during the actual operation, the sutures must be tied to the soft tissue first, and then the soft tissue is fixed to the anchor or the surgical point by tying a knot. This method is certainly effective, but people in the industry know that when there is a foreign body in the human body, it will usually grow a "bag" of connective tissue to wrap the foreign body during the later recovery. The knot of the suture is equivalent to the foreign body. The larger the knot, the larger the "bag" and the more prone to inflammation.

Summary of the invention

In order to solve the above technical problems, the present invention provides a bone implant, a positioning sleeve, an inserter and an implantation system for soft tissue fixation. The bone implant provided by the present invention can implant two bone implants into the bone at the same time to achieve soft tissue fixation. At the same time, the two bone implants are connected by two connecting elements without the need to tie a knot on the bone surface.

To achieve the above object, the technical solution of the present invention is:

A bone implant for soft tissue fixation, comprising a first bone implant and a second bone implant and a coupling element, wherein the first bone implant comprises a first suture and a first round sheath, and the first suture passes through the first round sheath;

The second bone implant comprises a second suture and a second round sheath, the second suture passing through the second round sheath;

The first suture forms a suture loop and passes through the coupling element to be free outside the coupling element, and the second suture forms a suture loop and passes through the coupling element to be free outside the coupling element;

After the first bone implant and the second bone implant are respectively configured on the target object, the first round sheath and the second round sheath are deformed into flexible knots, respectively tightening the first suture and the second suture, and the coupling element is fixed. On the surface of the target object.

In one embodiment of the present invention, the bone implant is a braided wire, the connecting element is a round tube on the braided wire, the through holes at both ends of the round tube are the first hole and the second hole, and the braided wires on both sides of the round tube are the first suture and the second suture.

In one embodiment of the present invention, the first suture is bent and inserted into the first hole of the coupling element and exits from the second hole; the second suture is bent and inserted into the second hole of the coupling element and exits from the first hole.

In one embodiment of the present invention, the connecting element further has a third hole and/or a fourth hole, the first suture is bent and inserted into the first hole of the connecting element, and comes out from the third hole or the fourth hole; the second suture is bent and inserted into the second hole of the connecting element, and comes out from the third hole or the fourth hole.

In one embodiment of the present invention, the braided wire is braided from ultra-high molecular weight polyethylene fiber or polyester fiber raw material.

In one embodiment of the present invention, the first circular sheath and/or the second circular sheath are respectively a sleeve structure formed by weaving, the first circular sheath is sleeved on the first suture, and the second circular sheath is sleeved on the second suture.

In one embodiment of the present invention, the cross section of the sleeve structure is circular or flat.

In one embodiment of the present invention, the first round sheath and/or the second round sheath are both sheet-like woven structures.

The first round sheath is provided with at least a first threading hole and a second threading hole, and the first suture passes through the first threading hole and the second threading hole in sequence;

The second round sheath is provided with at least a third threading hole and a fourth threading hole, and the second suture passes through the third threading hole and the fourth threading hole in sequence.

The present invention also provides an inserter, which is applied to the above-mentioned bone implant for soft tissue fixation, comprising a handle and a first shaft and a second shaft, wherein the first shaft and the second shaft are fixed to the handle, the distal end of the first shaft has a first groove along the axial direction of the first shaft, the distal end of the second shaft has a second groove along the axial direction of the second shaft, the first round sheath in the first bone implant is embedded in the first groove, the second round sheath in the second bone implant is embedded in the second groove, and the first suture and the second suture are pulled. The first round sheath abuts against the first groove, and the second round sheath abuts against the second groove.

In one embodiment of the present invention, the connecting element of the bone implant is detachably connected to the handle, and the free ends of the first suture and the second suture are free outside the inserter. After the connecting element is fixed to the handle, the first round sheath and the second round sheath are respectively against the first groove and the second groove.

In one embodiment of the present invention, the handle comprises a first handle and a second handle, a gap is provided at the distal end joint of the first handle and the second handle, and the coupling element is detachably pressed at the gap.

In one embodiment of the present invention, a pressing piece is provided on the first handle for controlling the coupling element to be pressed at the gap.

In one embodiment of the present invention, a third groove is defined in the second handle, an elastic member is disposed in the third groove, one end of the elastic member is fixedly connected to the second handle, and the other end is fixedly connected to the pressing member, the pressing member extends along the axial direction of the inserter to form an extension portion, and the extension portion and the handle compress the connecting element by extrusion.

In one embodiment of the present invention, the first shaft and the second shaft are made of titanium alloy, stainless steel or nickel-titanium alloy.

The present invention also provides a positioning sleeve, which is applied to the above-mentioned bone implant for soft tissue fixation and the above-mentioned inserter, the positioning sleeve comprises a first sleeve, a second sleeve and a shell, the first sleeve and the second sleeve are fixed in the shell, and the positioning sleeve is used to locate a target position on a target object;

The first shaft and the second shaft of the inserter are respectively inserted into the first sleeve and the second sleeve, and pass through the first sleeve and the second sleeve.

In one embodiment of the present invention, the first sleeve and the second sleeve are made of titanium alloy, stainless steel or nickel-titanium alloy.

The present invention also provides an implant system for soft tissue fixation, comprising the above-mentioned bone implant, the above-mentioned inserter and the above-mentioned positioning sleeve, wherein the positioning sleeve is used to locate a target position on a target object, and the inserter is used to configure the bone implant in the target object;

The bone implant comprises a first bone implant and a second bone implant and a coupling element, the first bone implant comprising a first suture and a first round sheath, the first suture passing through the first round sheath;

The inserter includes a handle and a first shaft and a second shaft, the first shaft and the second shaft are fixed to the handle, the distal end of the first shaft has a first groove along the axial direction of the first shaft, the distal end of the second shaft has a second groove along the axial direction of the second shaft, the first circular sheath in the first bone implant is embedded in the first groove, and the second circular sheath in the second bone implant is embedded in the second groove, and when the first suture and the second suture are pulled, the first circular sheath abuts against the first groove, and the second circular sheath abuts against the second groove.

The positioning sleeve comprises a first sleeve, a second sleeve and a shell, the first sleeve and the second sleeve are fixed in the shell, and the positioning sleeve is used to locate a target position on a target object;

The positioning sleeve is positioned at a target position on the surface of the target object, the first bone implant is embedded in the first groove, the second bone implant is embedded in the second groove, the first shaft and the second shaft are respectively inserted into the first sleeve and the second sleeve until the distal end of the handle contacts the proximal end of the positioning sleeve, the first bone implant and the second bone implant are respectively configured in the target object, the inserter is pulled out, the first circular sheath and the second circular sheath are both deformed and contracted to form a flexible knot, the inserter and the positioning sleeve are completely pulled out, the free ends of the first suture and the second suture are respectively pulled, and the connecting element is fixed to the surface of the target object.

Due to the adoption of the above technical solution, the present invention has the following advantages and positive effects compared with the prior art:

The bone implant provided by the present invention comprises a first bone implant, a second bone implant and a connecting element connecting the first bone implant and the second bone implant, wherein the first bone implant comprises a first suture and a first round sheath, the second bone implant comprises a second suture and a second round sheath, the first bone implant and the second bone implant are respectively implanted in respective bone tunnels, and at least one of the two medullary canals is punched on a bone with soft tissue, and the first suture and the second suture are respectively pulled, and the first round sheath and the second round sheath respectively form flexible knots in the bone. In addition, since both the first suture and the second suture pass through the connecting element, after the first bone implant and the second bone implant, the first suture and the second suture are pulled again, and the connecting element is also fixed on the bone, and the connecting element is equivalent to a lock, fixing the soft tissue on the bone surface without tying knots outside the soft tissue, thereby achieving a knot-free effect.

The bone implant provided by the present invention can replace the traditional anchor with wire function, and realize the inner and outer rows of anchors at the same time. During the fixation, the redundant first and second sutures are removed after the bone implant is implanted into the bone, which not only achieves the knot-free effect, but also allows the inner and outer row anchors to be implanted at the same time, greatly reducing the surgical operation time.

The present invention uses a coupling element to connect the first bone implant and the second bone implant. After the first bone implant and the second bone implant are implanted into the bone, the coupling element fixes the soft tissue on the bone surface after the first suture and the second suture are tightened, and the coupling element is also fixed on the bone surface. Therefore, the bone implant of the present invention is directly used for soft tissue fixation, and the soft tissue can be quickly fixed to the bone surface. In addition, the first bone implant and the second bone implant can be transformed into a flexible knot after being implanted into the bone, so the two bone implants of the present invention also replace the function of the full suture anchor.

The present invention also provides an inserter for driving the bone implant of the present invention, the inserter comprising a handle and a first shaft and a second shaft, the first shaft and the second shaft are both fixed at the distal end of the handle, the first round sheath of the bone implant is embedded in the first groove at the distal end of the first shaft, the second round sheath is embedded in the second groove at the distal end of the second shaft, the coupling element connecting the first bone implant and the second bone implant is preferably detachably pressed at the handle, and the first suture and the second suture are free outside the handle. Preferably, a pressing piece is used to control whether the coupling element is pressed at the handle. By knocking the proximal end of the handle, the first bone implant and the second bone implant can be implanted into the bone.

The present invention also provides a positioning sleeve for positioning and punching a suitable medullary canal on the bone surface. The positioning catheter includes a first sleeve and a second sleeve. Generally, a Kirschner wire is used to punch a medullary canal in the bone. First, a Kirschner wire is used to punch a hole at a suitable position of the patient, and then the Kirschner wire is retained at the positioning point. Then, the first sleeve is inserted, the positioning sleeve is rotated, and a second position point is found. Then, another Kirschner wire is inserted into the second sleeve to punch a second medullary canal. During the implantation of the bone implant, after the first bone implant and the second bone implant are respectively installed on the first shaft and the second shaft, the Kirschner wires in the first sleeve and the second sleeve are taken out, the first shaft and the second shaft are respectively inserted into the first sleeve and the second sleeve, and the proximal end of the inserter is knocked until the distal end of the inserter handle contacts the proximal end of the positioning sleeve. At this time, the first bone implant and the second bone implant are implanted into the bone tunnel, and then the inserter is pulled out of the positioning sleeve by one end distance, so that the first round sheath and the second round sheath are formed into a flexible knot, and then the coupling element is released, the inserter and the positioning sleeve are taken out, and the first suture and the second suture are pulled to fix the coupling element on the bone surface, and finally the soft tissue is fixed on the bone surface.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG1 is a structural diagram of an implementation of a bone implant for soft tissue fixation according to Example 1 of the present invention;

FIG2 is a schematic diagram of a state where the bone implant for soft tissue fixation according to Example 1 of the present invention is implanted into a bone;

FIG3 is a structural diagram of another embodiment of the bone implant for soft tissue fixation according to Example 1 of the present invention;

FIG4 is a schematic diagram of the structure of an inserter according to Embodiment 2 of the present invention;

FIG5 is an enlarged view of portion A in FIG4 ;

FIG6 is a schematic diagram of the structure of the inserter and the bone implant after assembly according to Embodiment 2 of the present invention;

FIG7 is an enlarged view of portion B in FIG6 ;

FIG8 is a cross-sectional view of the handle of the inserter according to Embodiment 2 of the present invention;

FIG9 is a schematic structural diagram of a positioning sleeve according to Embodiment 3 of the present invention;

FIG10 is a structural schematic diagram 1 of an implant system according to Embodiment 4 of the present invention;

FIG11 is a second structural schematic diagram of the implant system according to Embodiment 4 of the present invention;

FIG12 is a schematic diagram of a first round sheath or a second round sheath in a bone implant for soft tissue fixation according to Example 1 of the present invention in which the first round sheath or the second round sheath is flat;

13 is a schematic diagram showing that the first round sheath or the second round sheath in the bone implant for soft tissue fixation according to Example 1 of the present invention is a sheet-like woven structure.

Detailed ways

A bone implant, a positioning sleeve, an inserter and an implant system for soft tissue fixation proposed by the present invention are described in further detail below in conjunction with the accompanying drawings and specific embodiments. According to the following description, the advantages and features of the present invention will become clearer. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of the embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can be arranged and designed in various configurations.

Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the invention claimed for protection, but merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

It should be noted that similar reference numerals denote similar items in the following drawings, and therefore, once an item is defined in one drawing, further definition and explanation thereof is not required in the subsequent drawings.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. indicate positions or positional relationships based on the positions or positional relationships shown in the accompanying drawings, or the positions or positional relationships in which the inventive product is usually placed when in use. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific position, be constructed and operated in a specific position, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", "third", etc. are only used to distinguish the description, and cannot be understood as indicating or implying relative importance.

In addition, the terms "horizontal", "vertical" and the like do not mean that the components are required to be absolutely horizontal or suspended, but can be slightly tilted. For example, "horizontal" only means that its direction is more horizontal than "vertical", and does not mean that the structure must be completely horizontal, but can be slightly tilted.

In the description of this application, the “proximal end” refers to the end close to the operator, and the “distal end” refers to the end far from the operator.

It should be noted that as a wire anchor widely used in repairing damage at the junction of soft tissue and bone tissue, whether it is a wire anchor made of hard material or a wire anchor made of soft material, after the wire anchor is implanted in the bone, a wire guide is used to pass the suture free outside the bone through the soft tissue, tighten the suture and tie a knot on the surface of the soft tissue to fix it, thereby repairing the damaged soft tissue.

Therefore, in actual surgery, the sutures must first pass through the soft tissues, and then be fixed to the anchor point or surgical site by tying knots. This method is certainly effective, but people in the industry know that when there is a foreign body in the human body, a "bag" of connective tissue will usually grow to wrap the foreign body during the later recovery period. The knot of the suture is equivalent to the foreign body. The larger the knot, the larger the "bag" and the more prone to inflammation.

Example 1

Based on the above reasons, referring to FIG. 1 , this embodiment provides a bone implant for soft tissue fixation, comprising a first bone implant 1 and a second bone implant 2 and a coupling element 3, wherein the first bone implant 1 comprises a first suture 102 and a first round sheath 101, and the first suture 102 passes through the first round sheath 101;

The second bone implant 2 comprises a second suture 202 and a second round sheath 201, and the second suture 202 passes through the second round sheath 201;

The first suture 102 forms a suture loop and passes through the coupling element 3 to be free outside the coupling element 3. The second suture 202 forms a suture loop and passes through the coupling element 3 to be free outside the coupling element 3.

After the first bone implant 1 and the second bone implant 2 are respectively arranged in the bone, the first circular sheath 101 and the second circular sheath 201 are deformed into flexible knots 1', 2', respectively tightening the first suture 102 and the second suture 202, and the connecting element 3 is fixed on the bone surface.

The bone implant provided in this embodiment includes a first bone implant 1 (first anchor), a second bone implant 2 (second anchor), and a connecting element 3 connecting the first bone implant 1 and the second bone implant 2. The first bone implant 1 includes a first suture 102 and a first round sheath 101, and the second bone implant 2 includes a second suture 202 and a second round sheath 201. In the actual operation, two bone canals are firstly punched in the patient's bone, and at least one of the two bone tunnels is punched on the surface of the bone 5 with soft tissue 4. The first bone implant 1 and the second bone implant 2 are implanted into the two bone canals respectively. After the first bone implant 1 and the second bone implant 2 are implanted, the first round sheath 101 and the second round sheath 201 are deformed into flexible knots 1', 2' (as shown in FIG. 2). Since the first suture 102 passes through the coupling element 3 and is free outside, and the second suture 202 passes through the coupling element 3 and is free outside, the free ends of the first suture 102 and the second suture 202 are pulled respectively, so that the coupling element 3 is uniformly moved forward and finally fixed on the surface of the bone 5, so that the soft tissue 4 is fixed on the surface of the bone 5, and the redundant first suture 102 and the second suture 202 are cut off. After the first bone implant 1 and the second bone implant 2 are implanted, the coupling element 3 is equivalent to a lock, which fixes the soft tissue 4 on the surface of the bone 5 (as shown in FIG. 2), and the first suture 102 and the second suture 202 do not need to be knotted, so the knot-free effect is achieved, thereby avoiding inflammation in the later recovery period.

At the same time, after the first bone implant 1 and the second bone implant 2 are implanted, the first round sheath 101 and the second round sheath 102 are The two round sheaths 201 can be deformed into flexible knots 1', 2', indicating that the bone implant of this embodiment is equivalent to an anchor of soft material. The first round sheath 101 and the second round sheath 201 can be made of materials that can be used to make sutures. At the same time, there is no need to drill deeper medullary canals in the patient's bones. For the patient, the pain is reduced and the recovery period of the operation is also shortened.

It should be noted that in the prior art, the soft tissue 4 is repaired with a wire anchor, but there is a problem of insufficient fixing strength, and a knotless anchor needs to be used in conjunction with the wire anchor. After the wire anchor is implanted in the bone, the soft tissue 4 is fixed to the bone surface with sutures, and then a medullary canal is made at a suitable position, and the sutures are passed through the threading holes of the knotless anchor. When the knotless anchor is implanted in the bone tunnel, the sutures of the soft tissue 4 are also fixed in the bone. A suture bridge is formed between the wire anchor and the knotless anchor (the wire anchor is usually called the inner row anchor, and the knotless anchor is usually called the outer row anchor), which fixes the soft tissue 4 to the bone surface, but the inner row anchor and the outer row anchor need to be implanted into the bone one after another.

The bone implant of this embodiment has two bone implants, and the first bone implant 1 and the second bone implant 2 are directly implanted at the same time, that is, the inner row of anchors and the outer row of anchors are implanted at the same time, which can not only repair the soft tissue 4, but also greatly reduce the surgical operation time.

1 , the bone implant may be a braided wire formed by weaving, the connecting element 3 is a round tube on the braided wire, the through holes at both ends of the round tube are a first hole 301 and a second hole 302, and the round tube divides the braided wire into a first suture 102 and a second suture 202, that is, the braided wires on both sides of the round tube are the first suture 102 and the second suture 202.

In one implementation of this embodiment, the first suture 102 is bent and inserted into the first hole 301 of the coupling element 3, and comes out from the second hole 302. The first suture 102 forms a first U-shape, and the first round sheath 101 is arranged at the bottom of the first U-shape; the second suture 202 is bent and inserted into the second hole 302 of the coupling element 3, and comes out from the first hole 301. A second U-shape is formed, and the second round sheath 201 is arranged at the bottom of the second U-shape. By pulling the free ends of the first suture 102 and the second suture 202, the apertures of the suture loops formed by the first suture 102 and the second suture 202 can be reduced, and the coupling element 3 approaches the first round sheath 101 and the second round sheath 201.

In another embodiment of this embodiment, referring to FIG. 3 , the coupling element 3 further has a third hole 303 . The first suture 102 is bent and inserted into the first hole 301 of the coupling element 3, and comes out from the third hole 303; the second suture 202 is bent and inserted into the second hole 302 of the coupling element 3, and comes out from the third hole 303, that is, the first suture 102 and the second suture 202 both come out from the third hole 303, and the first suture 102 and the second suture 202 can also come out from different holes, that is, the coupling element 3 also has a fourth hole, that is, the first suture 102 is bent and inserted into the first hole 301 of the coupling element 3, and comes out from the third hole 303; the second suture 202 is bent and inserted into the second hole 302 of the coupling element 3, and comes out from the fourth hole. Two implementation methods are adopted, and the free ends of the first suture 102 and the second suture 202 are pulled tight, so that the coupling element 3 can also be brought close to the first round sheath 101 and the second round sheath 201.

The braided wire can be braided from ultra-high molecular weight polyethylene fiber or polyester fiber raw material.

In one implementation of this embodiment, the first round sheath 101 and the second round sheath 201 are respectively woven sleeve structures, the first round sheath 101 is sleeved on the first suture 102, and the second round sheath 201 is sleeved on the second suture 202. The cross section of the sleeve structure is circular (as shown in FIGS. 1 and 3 ) or flat (as shown in FIG. 12 using the first round sheath as an example), and of course, it can also be other shapes such as square, which is not limited here.

In another embodiment of the present embodiment, as shown in FIG. 13 , the first round sheath 101 and the second round sheath 201 may also be constructed as a sheet-like woven structure, and the first round sheath 101 is provided with at least a first threading hole and a second threading hole, and the first suture 102 passes through the first threading hole and the second threading hole in sequence;

The second round sheath 201 is provided with at least a third threading hole and a fourth threading hole, and the second suture 202 passes through the third threading hole and the fourth threading hole in sequence;

The first suture 102 and the first circular sheath 101, the second suture 202 and the second circular sheath 201 can move relative to each other. After the first bone implant 1 and the second bone implant 2 are implanted into the medullary canal, the first circular sheath 101 and the second circular sheath 201 are folded and deformed, and finally form flexible knots 1' and 2'. Of course, in addition to having two threading holes, the first circular sheath 101 and the second circular sheath 201 can also have three or four threading holes (four threading holes are shown in FIG. 13 ), which will not be described in detail here.

The first round sheath and the second round sheath can be both a sleeve structure or a sheet-like woven structure. When forming the first bone implant and the second bone implant, the first round sheath and the second round sheath can be both a sleeve structure or a sheet-like woven structure. woven structure; when both are sleeve structures, the cross-sections of the first round sheath and the second round sheath may be the same shape or different shapes; when both are sheet-like woven structures, the first round sheath and the second round sheath may have the same number of threading holes or different numbers of threading holes; the first round sheath and the second round sheath may also be sleeve structures and sheet-like woven structures.

Example 2

Since the embodiment 1 provides two all-suture anchors that can be implanted at one time, the present embodiment provides an inserter 6 for a bone implant used for fixing a soft tissue 4 in the embodiment 1, specifically referring to FIGS. 4-8, comprising a handle 603 and a first shaft 601 and a second shaft 602, the handle 603, the first shaft 601, and the second shaft 602 all having a proximal end and a distal end, the distal end of the first shaft 601 and the distal end of the second shaft 602 being fixed to the handle 603, referring to FIG. 5, the distal end of the first shaft 601 has a proximal end and a distal end. A shaft 601 has an axial first groove 6011, and a distal end of the second shaft 602 has a second groove 6021 along the axial direction of the second shaft 602. The first circular sheath 101 in the first bone implant 1 is embedded in the first groove 6011, and the second circular sheath 201 in the second bone implant 2 is embedded in the second groove 6021. The first suture 102 and the second suture 202 are pulled, and the first circular sheath 101 abuts against the first groove 6011, and the second circular sheath 201 abuts against the second groove 6021 (see Figure 7).

After the first circular sheath 101 and the second circular sheath 201 are respectively embedded in the first groove 6011 and the second groove 6021, the connecting element 3 can be fixed on the handle 603 or fixed outside the handle 603. Preferably, the connecting element 3 of the bone implant is detachably connected to the handle 603. Referring to Figures 6-7, the free ends of the first suture 102 and the second suture 202 are free outside the inserter 6. After the connecting element 3 is fixed to the handle 603, the first circular sheath 101 and the second circular sheath 201 are respectively against the first groove 6011 and the second groove 6021.

Specifically, the handle 603 includes a first handle 6031 and a second handle 6032 . A gap is provided at the distal joint of the first handle 6031 and the second handle 6032 , and the coupling element 3 is detachably pressed in the gap.

The first handle 6031 is provided with a pressing member 604 for controlling the coupling element 3 to be pressed at the gap. Specifically, a third groove 607 is provided in the second handle 6032, and an elastic member 606 is provided in the third groove 607. One end of the elastic member 606 is fixedly connected to the second handle 6032, and the other end is fixedly connected to the pressing member 604. The pressing member 604 extends along the axial direction of the inserter 6 to form an extension portion 6041. The extension portion 6041 and the handle 603 are pressed to press the coupling element 3. Pressing the pressing member 604 separates the extension portion 6041 from the handle 603, and the coupling element 3 can be placed in the third groove 607. After releasing the pressing member 604, the elastic member 606 rebounds, and the extension portion 6041 contacts the handle 603, and the coupling element 3 is pressed by pressing. Pressing the pressing member 604 again can release the coupling element 3 from the joint gap between the first handle 6031 and the second handle 6032.

The material of the first shaft 601 and the second shaft 602 can be titanium alloy, stainless steel or nickel-titanium alloy, which is not limited here.

Example 3

This embodiment provides a positioning sleeve 7, which is applied to the bone implant for fixing soft tissue 4 in embodiment 1, and the inserter 6 in embodiment 2. Specifically referring to FIG9, the positioning sleeve 7 includes a first sleeve 701, a second sleeve 702 and a shell 703. The first sleeve 701 and the second sleeve 702 are fixed in the shell 703, and the first sleeve 701 and the second sleeve 702 are arranged in the shell 703. When the bone marrow canal is drilled on the bone surface, the positioning sleeve 7 is used to locate the target position on the bone surface. First, an electric drill is used to drill a Kirschner wire at a suitable position where the soft tissue 4 needs to be repaired to locate the bone marrow canal, and then the electric drill is removed, and the Kirschner wire is kept at the positioning point, and then the Kirschner wire at the positioning point is inserted into the first sleeve 701 of the positioning sleeve 7, and the positioning sleeve 7 is rotated to find a second position point, and then another Kirschner wire is inserted into the second sleeve 702, and another bone marrow canal is drilled using the electric drill. The distance between the first sleeve 701 and the second sleeve 702 can be specifically set according to the repair of soft tissue 4 in different parts or different patients.

When implanting the bone implant, the Kirschner wires in the first sleeve 701 and the second sleeve 702 are taken out, and the first shaft 601 and the second shaft 602 of the inserter 6 are respectively inserted into the first sleeve 701 and the second sleeve 702 (see FIGS. 10-11 ).

The material of the first sleeve 701 and the second sleeve 702 can be titanium alloy, stainless steel or nickel-titanium alloy, which is not limited here.

Example 4

10-11, this embodiment provides an implant system for fixing soft tissue 4, including: The bone implant of Example 1, the inserter 6 of Example 2 and the positioning sleeve 7 of Example 3 use the inserter 6 and the positioning sleeve 7 to simultaneously implant the first bone implant 1 and the second bone implant 2 of the bone implant into the damaged soft tissue 4, thereby fixing the soft tissue 4 on the bone surface.

When the positioning sleeve 7 is used to locate the target position, first use an electric drill to insert a Kirschner wire to locate the medullary canal at a suitable position of the soft tissue 4 to be repaired, then remove the electric drill, keep the Kirschner wire at the positioning point, then insert the Kirschner wire at the positioning point into the first sleeve 701 of the positioning sleeve 7, rotate the positioning sleeve 7, find the second position point, then insert another Kirschner wire into the second sleeve 702, and use the electric drill to drill another medullary canal;

When implanting the bone implant, the first bone implant 1 is embedded in the first groove 6011, and the second bone implant 2 is embedded in the second groove 6021, and then the pressing piece 604 is pressed to embed the connecting element 3 into the joint gap between the first handle 6031 and the second handle 6032, and then the pressing piece 604 is released, the connecting element 3 is fixed at the joint gap between the first handle 6031 and the second handle 6032, and the first suture 102 and the second suture 202 are free outside the handle 603, and then the Kirschner wires in the first sleeve 701 and the second sleeve 702 are taken out, and the first shaft 601 and the second shaft 602 of the inserter 6 are respectively inserted into the first sleeve 701 and the second sleeve 702, and the proximal end of the handle 603 is knocked with an instrument until the distal end of the handle 603 contacts the proximal end of the positioning sleeve 7;

After the insertion device 6 is slightly pulled out for a distance, the first round sheath 101 and the second round sheath 201 are formed into flexible knots 1', 2', and then the pressing member 604 is pressed to release the coupling element 3, and the insertion device 6 and the positioning sleeve 7 are taken out. Finally, the free ends of the first suture 102 and the second suture 202 are pulled evenly to make the coupling element 3 move evenly and finally fixed on the surface of the soft tissue 4, and the excess first suture 102 and the second suture 202 are cut off. The state after the bone implant is finally implanted into the bone 5 is shown in FIG2.

The bone implant of this embodiment is suitable for at least one medullary canal on the bone surface with soft tissue 4. After the first bone implant 1 and the second bone implant 2 are implanted, the coupling element 3 is equivalent to a lock and is fixed on the bone surface. If there is soft tissue 4 at one place, the soft tissue 4 can be fixed to the bone. It is particularly suitable for repair surgery in which the soft tissue 4 is torn off or torn from the bone surface.

The embodiments of the present invention are described in detail above with reference to the accompanying drawings, but the present invention is not limited to Even if various changes are made to the present invention, if these changes fall within the scope of the claims of the present invention and their equivalents, they still fall within the protection scope of the present invention.

Claims

A bone implant for soft tissue fixation, characterized in that it comprises a first bone implant and a second bone implant and a coupling element, wherein the first bone implant comprises a first suture and a first round sheath, and the first suture passes through the first round sheath;

The second bone implant comprises a second suture and a second round sheath, the second suture passing through the second round sheath;

The first suture forms a suture loop and passes through the coupling element to be free outside the coupling element, and the second suture forms a suture loop and passes through the coupling element to be free outside the coupling element;

After the first bone implant and the second bone implant are respectively configured on the target object, the first circular sheath and the second circular sheath are deformed into flexible knots, respectively tightening the first suture and the second suture, and the connecting element is fixed on the surface of the target object.
The bone implant for soft tissue fixation according to claim 1 is characterized in that the bone implant is a braided wire formed by weaving, the connecting element is a round tube on the braided wire, the through holes at both ends of the round tube are the first hole and the second hole, and the braided wires on both sides of the round tube are the first suture and the second suture.
The bone implant for soft tissue fixation according to claim 2 is characterized in that the first suture is bent and penetrates into the first hole of the connecting element and comes out from the second hole; the second suture is bent and penetrates into the second hole of the connecting element and comes out from the first hole.
The bone implant for soft tissue fixation according to claim 2 is characterized in that the connecting element also has a third hole and/or a fourth hole, the first suture is bent and inserted into the first hole of the connecting element, and passes out from the third hole or the fourth hole; the second suture is bent and inserted into the second hole of the connecting element, and passes out from the third hole or the fourth hole.
The bone implant for soft tissue fixation according to claim 2 is characterized in that the braided wire is woven from ultra-high molecular weight polyethylene fiber or polyester fiber raw material.
The bone implant for soft tissue fixation according to any one of claims 1 to 5, characterized in that the first round sheath and/or the second round sheath are respectively braided sleeve structures, and the first The round sheath is sleeved on the first suture, and the second round sheath is sleeved on the second suture.
The bone implant for soft tissue fixation according to claim 6, characterized in that the cross-section of the sleeve structure is circular or flat.
The bone implant for soft tissue fixation according to any one of claims 1 to 5, characterized in that the first round sheath and/or the second round sheath are both sheet-like woven structures,

The first round sheath is provided with at least a first threading hole and a second threading hole, and the first suture passes through the first threading hole and the second threading hole in sequence;

The second round sheath is provided with at least a third threading hole and a fourth threading hole, and the second suture passes through the third threading hole and the fourth threading hole in sequence.
An inserter, applied to the bone implant for soft tissue fixation according to any one of claims 1 to 8, characterized in that it includes a handle and a first axis and a second axis, the first axis and the second axis are fixed to the handle, the distal end of the first axis has a first groove, the distal end of the second axis has a second groove, the first round sheath in the first bone implant abuts against the bottom of the first groove, and the second round sheath in the second bone implant abuts against the bottom of the second groove.
The inserter according to claim 9, characterized in that the coupling element of the bone implant is detachably connected to the handle, and the free ends of the first suture and the second suture are free outside the inserter.
The inserter according to claim 10, characterized in that the handle includes a first handle and a second handle, and the coupling element is detachably pressed at a junction of the distal ends of the first handle and the second handle.
The inserter according to claim 10 or 11 is characterized in that a pressing piece is provided on the first handle for controlling the connecting element to be pressed at the gap.
The inserter according to claim 12 is characterized in that an elastic member is provided in the second handle, one end of the elastic member is fixedly connected to the second handle, and the other end is fixedly connected to the pressing member, the pressing member extends along the axial direction of the inserter to form an extension portion, and the extension portion and the handle press the connecting element through an extrusion effect.
The inserter according to claim 9 is characterized in that the first shaft and the second shaft are made of titanium alloy, stainless steel or nickel-titanium alloy.
A positioning sleeve, applied to the bone implant for soft tissue fixation according to any one of claims 1 to 8 and the inserter according to any one of claims 9 to 14, characterized in that the positioning sleeve comprises a first sleeve, a second sleeve and a shell, the first sleeve and the second sleeve are fixed in the shell, and the positioning sleeve is used to locate a target position on a target object;

The first shaft and the second shaft of the inserter are respectively inserted into the first sleeve and the second sleeve and pass through the first sleeve and the second sleeve.
The positioning sleeve according to claim 15 is characterized in that the first sleeve and the second sleeve are made of titanium alloy, stainless steel or nickel-titanium alloy.
An implant system for soft tissue fixation, characterized in that it comprises a bone implant for soft tissue fixation as described in any one of claims 1 to 8, an inserter as described in any one of claims 9 to 14, and a positioning sleeve as described in claim 14 or 15, wherein the positioning sleeve is used to locate a target position on a target object, and the inserter is used to drive the bone implant to be configured in the target object.
The soft tissue fixation implant system according to claim 17, characterized in that the positioning sleeve locates the target position, the first bone implant is embedded in the first groove, the second bone implant is embedded in the second groove, the first shaft and the second shaft are respectively inserted into the first sleeve and the second sleeve, the inserter is struck until the distal end of the handle contacts the proximal end of the positioning sleeve, and the first bone implant and the second bone implant are respectively configured into the target object;

When the inserter is partially pulled out, the first circular sheath and the second circular sheath are deformed and contracted to form a flexible knot, and the inserter and the positioning sleeve are completely pulled out, and the free ends of the first suture and the second suture are pulled respectively, and the connecting element is fixed on the surface of the target object.