CN115778457A - Bone implant, positioning sleeve, inserter and implantation system - Google Patents
Bone implant, positioning sleeve, inserter and implantation system Download PDFInfo
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- CN115778457A CN115778457A CN202211406025.2A CN202211406025A CN115778457A CN 115778457 A CN115778457 A CN 115778457A CN 202211406025 A CN202211406025 A CN 202211406025A CN 115778457 A CN115778457 A CN 115778457A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
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- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- Heart & Thoracic Surgery (AREA)
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Abstract
The invention discloses a bone implant, a positioning sleeve, an inserter and an implantation system for soft tissue fixation, wherein the bone implant comprises a first bone implant and a second bone implant and a coupling element, 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 is free outside the linking element through the linking element after forming the suture loop, and the second suture is free outside the linking element through the linking element after forming the suture loop; after the first and second bone implants are deployed on the target object, respectively, the first and second sheaths are deformed into flexible knots that tighten the first and second sutures, respectively, and the coupling element is secured to the surface of the target object. The invention can implant two bone implants into bone at the same time to realize soft tissue fixation, and simultaneously, the two bone implants are connected by two connecting elements without knotting on the bone surface.
Description
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to a bone implant, a positioning sleeve, an inserter and an implantation system for soft tissue fixation.
Background
In recent years, the suture anchor technology using titanium alloy, PEEK and polylactic acid as materials is widely used for repairing the damage of the soft tissue and bone tissue connection, such as: rotator cuff injury, labral injury, femoral proximal tendon injury, injury to the anterior and posterior aspects of the labrum on the shoulder joint, ulnar collateral ligament injury reconstruction, biceps brachii distal tendon injury, navicular intercostal ligament repair, triangular fibrocartilage repair, extensor tendon injury repair, and the like. The hard anchor is screwed on the bone tissue near the position needing to be fixed like a screw, the preloaded suture on the anchor penetrates through the soft tissue needing to be repaired, and the soft tissue is contacted and fixed with the surface of the bone tissue by binding and tensioning the suture, so that the physical repair of the damaged tissue is completed.
As the use of hard material anchor technology has become widespread, hard material anchors are known to suffer from a number of drawbacks: after the titanium alloy metal anchor is implanted, inflammation is easy to occur due to rejection reaction, so that bone dissolution occurs at an implanted part, the anchor is loosened and displaced, and the fixing failure is caused. PLA absorbable anchors may be degraded and broken prematurely after being implanted, the fixing firmness is reduced due to the fact that the anchor is displaced secondarily, and synovitis, osteolysis and other problems may be caused by degradation products. Although the problem that the titanium alloy anchor is easy to loosen and shift after being implanted is solved by the suture anchor made of the PEEK material, the problems that the anchor made of the absorbable material is cracked or degraded prematurely after being implanted into a person, the fixation firmness is reduced due to secondary shift, synovitis and bone dissolution are easily caused by degraded substances, the problem that the bone path of the implanted part of the anchor is large, the bone removal amount is large, and fracture or bone fracture is easy to occur are solved. In addition, once detached from the bone tract after implantation, hard anchors can cause damage to nearby joint tissue and bone surfaces; the hard anchor is difficult to repair and causes great pain to patients.
In order to solve the problems of hard material anchors, full suture anchor products have emerged. The anchor portion of the product is made of a material that can be used to make sutures. Has the following advantages: the shape of the soft material anchor can be changed at will, the bone path required by fixation is small, and the bone removal amount is small; the bone tunnel is easy to remove and repair, the bone tunnel can be slightly enlarged during repair, and hard material anchors are used for replacement; even if the soft full suture anchor is separated from the bone canal after being implanted, the soft full suture anchor can not damage the surrounding joints and the surface of the bone.
In the actual operation, the suture needs to be tied with the soft tissue first, and then the soft tissue is fixed at the anchoring or operation point by knotting. The method is effective, but as known by people in the industry, when foreign matters in human bodies are recovered at a later stage, connective tissues like bags are usually grown to wrap the foreign matters, the knotting of the suture is equivalent to the foreign matters, and the larger the knot is, the larger the bag is, and the foreign matters are easy to be inflamed.
Disclosure of Invention
The bone implant provided by the invention can simultaneously implant two bone implants into bone to realize soft tissue fixation, and simultaneously the two bone implants are connected by adopting two coupling elements without knotting on the bone surface.
In order to realize the purpose, the technical scheme of the invention is as follows:
a bone implant for soft tissue fixation comprising 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 second bone implant comprises a second suture and a second round sheath through which the second suture passes;
said first suture being free from said coupling element through said coupling element after forming a suture loop, said second suture being free from said coupling element through said coupling element after forming a suture loop;
after the first and second bone implants are deployed on the target object, the first and second circular sheaths are deformed into flexible knots to tighten the first and second sutures, respectively, and the coupling element is fixed on the surface of the target object.
In one embodiment of the invention, the bone implant is a braided wire formed by braiding, the coupling element is a circular tube on the braided wire, the through holes at two ends of the circular tube are a first hole and a second hole, and the braided wire at two sides of the circular tube is a first suture and a second suture.
In one embodiment of the invention, the first suture bend passes through a first hole of the coupling element and out of a second hole; the second suture bend passes through a second aperture of the coupling element and out of the first aperture.
In one embodiment of the invention, the coupling element is further provided with a third hole and/or a fourth hole, and the first suture is bent to penetrate into the first hole of the coupling element and penetrate out of the third hole or the fourth hole; the second suture bend passes through the second aperture of the coupling element and out of the third aperture or the fourth aperture.
In one embodiment of the present invention, the braided wire is formed by braiding a raw material of an ultra-high molecular weight polyethylene fiber or a raw material of a polyester fiber.
In an embodiment of the present invention, the first round sheath and/or the second round sheath are each a braided sleeve structure, the first round sheath is provided on the first suture, and the second round sheath is provided on the second suture.
In an embodiment of the present invention, the cross section of the sleeve structure is circular or flat.
In one embodiment of the invention, the first round sheath and/or the second round sheath are both in a sheet-shaped braided structure,
the first round sheath is at least provided with a first threading hole and a second threading hole, and the first suture line sequentially passes through the first threading hole and the second threading hole;
and the second round sheath is at least provided with a third threading hole and a fourth threading hole, and the second suture line sequentially passes through the third threading hole and the fourth threading hole.
The invention also provides an inserter which is applied to the bone implant for soft tissue fixation and comprises a handle, a first shaft and a second shaft, wherein the first shaft and the second shaft are fixed on the handle, the distal end of the first shaft is provided with a first groove along the axial direction of the first shaft, the distal end of the second shaft is provided with a second groove along the axial direction of the second shaft, a first round sheath in the first bone implant is embedded in the first groove, a second round sheath in the second bone implant is embedded in the second groove, the first suture and the second suture are pulled, the first round sheath is abutted in the first groove, and the second round sheath is abutted in the second groove.
In one embodiment of the invention, the coupling element of the bone implant is detachably connected to the handle, the free ends of the first and second sutures are free outside the inserter, and the first and second circular sheaths are seated within the first and second grooves, respectively, after the coupling element is secured at the handle.
In one embodiment of the invention, the handle comprises a first handle and a second handle, the joint of the distal ends of the first handle and the second handle is provided with a gap, and the connecting element is detachably pressed at the gap.
In an embodiment of the present invention, a pressing member is disposed on the first handle for controlling the coupling element to press the gap.
In an embodiment of the present invention, a third groove is formed 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, the other end of the elastic member is fixedly connected to the pressing member, the pressing member extends along an axial direction of the inserter to form an extending portion, and the extending portion and the handle press the coupling element by squeezing.
In an embodiment of the present invention, the first shaft and the second shaft are made of titanium alloy, stainless steel or nickel-titanium alloy.
The invention also provides a positioning sleeve for the bone implant for soft tissue fixation and the inserter, wherein 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 for positioning a target position on a target object;
the first and second shafts of the inserter are inserted into and exit the first and second cannulae, respectively.
In an embodiment of the present invention, the first sleeve and the second sleeve are made of titanium alloy, stainless steel or nickel-titanium alloy.
The invention also provides an implant system for soft tissue fixation, comprising the bone implant described above, an inserter described above for positioning a target site on a target object, and a positioning sleeve described above for deploying the bone implant within the target object;
a bone implant comprising first and second bone implants and a coupling element, the first bone implant comprising a first suture and a first round sheath through which the first suture passes;
the second bone implant comprises a second suture and a second round sheath through which the second suture passes;
said first suture being free from said coupling element through said coupling element after forming a suture loop, said second suture being free from said coupling element through said coupling element after forming a suture loop;
the inserter comprises a handle, a first shaft and a second shaft, wherein the first shaft and the second shaft are fixed on the handle, the distal end of the first shaft is provided with a first groove along the axial direction of the first shaft, the distal end of the second shaft is provided with a second groove along the axial direction of the second shaft, a first round sheath in the first bone implant is embedded in the first groove, a second round sheath in the second bone implant is embedded in the second groove, 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.
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 for positioning a target position on a target object;
the positioning sleeve is used for positioning a target position on the surface of a target object, a first bone implant is embedded in the first groove, a second bone implant is embedded in the second groove, a first shaft and a 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 and are drawn out of the inserter, the first round sheath and the second round sheath are deformed and contracted to form a flexible knot, the inserter and the positioning sleeve are completely drawn out, free ends of the first suture and the second suture are respectively pulled, and the coupling element is fixed on the surface of the target object.
In one embodiment of the invention, the bone implant is a braided wire formed by braiding, the coupling element is a circular tube on the braided wire, the through holes at two ends of the circular tube are a first hole and a second hole, and the braided wire at two sides of the circular tube is a first suture and a second suture.
In one embodiment of the invention, the first suture bend passes through a first hole of the coupling element and out of a second hole; the second suture bend passes through a second aperture of the coupling element and out of the first aperture.
In one embodiment of the invention, the coupling element is further provided with a third hole and/or a fourth hole, and the first suture is bent to penetrate into the first hole of the coupling element and penetrate out of the third hole or the fourth hole; the second suture bend passes through the second aperture of the coupling element and out of the third aperture or the fourth aperture.
In one embodiment of the present invention, the braided wire is formed by braiding a raw material of an ultra-high molecular weight polyethylene fiber or a raw material of a polyester fiber.
In an embodiment of the present invention, the first round sheath and/or the second round sheath are each a braided sleeve structure, the first round sheath is provided on the first suture, and the second round sheath is provided on the second suture.
In an embodiment of the present invention, the cross section of the sleeve structure is circular or flat.
In one embodiment of the invention, the first round sheath and/or the second round sheath are both in a sheet-shaped braided structure,
the first round sheath is at least provided with a first threading hole and a second threading hole, and the first suture line sequentially passes through the first threading hole and the second threading hole;
and the second round sheath is at least provided with a third threading hole and a fourth threading hole, and the second thread sequentially penetrates through the third threading hole and the fourth threading hole.
Due to the adoption of the technical scheme, compared with the prior art, the invention has the following advantages and positive effects:
the invention provides a bone implant comprising a first suture and a first round sheath, a second bone implant comprising a second suture and a second round sheath, the first and second bone implants being implanted in respective bone tunnels, and at least one of the two bone marrow tracts being made in a bone having soft tissue, the first and second sutures being withdrawn, respectively, the first and second round sheaths forming a flexible knot in the bone, respectively, and a coupling element connecting the first and second bone implants. In addition, because the first suture and the second suture are both passed through the coupling element, after the first bone implant and the second bone implant are pulled, the first suture and the second suture are drawn again, the coupling element is also fixed on the bone, and the coupling element is equivalent to a lock catch and fixes the soft tissue on the surface of the bone without knotting outside the soft tissue, thereby achieving the effect of avoiding knotting.
The bone implant provided by the invention can replace the traditional function of the anchor with the wire, so that the simultaneous fixation of the inner row of the anchors and the outer row of the anchors is realized, and the redundant first suture and second suture are omitted after the bone implant is implanted into the bone, so that the knotting-free effect is realized, the inner row of the anchors and the outer row of the anchors can be implanted simultaneously, and the operation time of the operation is greatly reduced.
The invention is characterized in that the first bone implant and the second bone implant are connected by the coupling element, after the first bone implant and the second bone implant are implanted into the bone, the coupling element fixes the soft tissue on the surface of the bone and fixes the coupling element on the surface of the bone after the first suture and the second suture are tightened. The bone implant of the invention is therefore used directly for soft tissue fixation, allowing rapid fixation of soft tissue to the bone surface. In addition, the first bone implant and the second bone implant can be deformed into a flexible knot after being implanted into the bone, so that the two bone implants of the invention also replace the function of a full suture anchor.
The invention also provides an inserter for driving the bone implant of the invention, the inserter comprising a handle and first and second shafts, each of the first and second shafts being fixed to a distal end of the handle, a first round sheath of the bone implant fitting into a first recess provided at a distal end of the first shaft and a second round sheath fitting into a second recess provided at a distal end of the second shaft, a coupling element connecting the first bone implant and the second bone implant being preferably releasably pressed at the handle, the first and second sutures being free from the handle. The pressing member is preferably used to control whether the coupling member is pressed at the handle. Tapping on the proximal end of the handle implants the first and second bone implants may be implanted into the bone.
The invention also provides a positioning sleeve for positioning and drilling a proper marrow channel on the surface of a bone, wherein the positioning guide pipe comprises a first sleeve and a second sleeve, the marrow channel is drilled in the bone by generally adopting a Kirschner wire, a hole is drilled and positioned at a proper position of a patient by adopting the Kirschner wire, then the Kirschner wire is kept at the positioning point, then the first sleeve is inserted, the positioning sleeve is rotated to search a second position point, and then another Kirschner wire is inserted into the second sleeve to drill a second marrow channel. During implantation of the bone implant, after the first and second bone implants are mounted on the first and second shafts, respectively, the kirschner wires in the first and second sleeves are removed, the first and second shafts are inserted into the first and second sleeves, respectively, the proximal end of the inserter is struck until the distal end of the inserter handle contacts the proximal end of the positioning sleeve, whereupon the first and second bone implants are implanted into the bone tunnel, the inserter is withdrawn from the positioning sleeve a distance to deform the first and second sheaths into flexible knots, the coupling element is then released, the inserter and positioning sleeve are removed, the first and second sutures are pulled, the coupling element is secured to the bone surface, and finally, securing of the soft tissue to the bone surface is achieved.
Drawings
FIG. 1 is a block diagram of one embodiment of a bone implant for soft tissue fixation according to example 1 of the present invention;
fig. 2 is a schematic view showing a state in which a bone implant for soft tissue fixation according to embodiment 1 of the present invention is implanted in a bone;
fig. 3 is a block diagram of another embodiment of a bone implant for soft tissue fixation according to example 1 of the present invention;
FIG. 4 is a schematic structural view of an interposer according to embodiment 2 of the present invention;
FIG. 5 is an enlarged view of portion A of FIG. 4;
FIG. 6 is a schematic view of the assembled inserter and bone implant of embodiment 2 of the present invention;
FIG. 7 is an enlarged view of portion B of FIG. 6;
FIG. 8 is a cross-sectional view at the handle of the inserter of embodiment 2 of the present invention;
FIG. 9 is a schematic structural view of a positioning sleeve according to embodiment 3 of the present invention;
FIG. 10 is a first schematic structural view of an implantation system according to embodiment 4 of the present invention;
FIG. 11 is a second schematic structural view of an implantation system according to embodiment 4 of the present invention;
fig. 12 is a schematic view 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 a flat shape;
fig. 13 is a schematic view showing the first round sheath or the second round sheath in the bone implant for soft tissue fixation according to embodiment 1 of the present invention in a sheet-like woven structure.
Detailed Description
A bone implant, a positioning sleeve, an inserter and an implantation system according to the present invention for soft tissue fixation will be described in further detail with reference to the accompanying drawings and specific embodiments. The advantages and features of the present invention will become more apparent from the following description. It is to be understood that the embodiments described are only a few embodiments of the present invention, and not all embodiments. The components of embodiments of the present invention generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations.
Thus, the following detailed description of the embodiments of the present invention, presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
It should be noted that: like reference numerals refer to like items in the following figures, and thus, once an item is defined in one figure, it need not be further defined and explained in subsequent figures.
In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. indicate orientations or positional relationships based on orientations or positional relationships shown in the drawings or orientations or positional relationships that the present product is conventionally placed in use, and are only for convenience of describing the present invention and simplifying the description, but do not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," "third," and the like are used solely to distinguish one from another and are not to be construed as indicating or implying relative importance.
Furthermore, the terms "horizontal", "vertical" and the like do not imply that the components are required to be absolutely horizontal or pendant, but rather may be slightly inclined. For example, "horizontal" merely means that the direction is more horizontal than "vertical" and does not mean that the structure must be perfectly horizontal, but may be slightly inclined.
In the description of the present application, "proximal" is the end closer to the operator and "distal" is the end further from the operator.
In addition, as a suture anchor widely used for repairing damage at a joint between soft tissue and bone tissue, regardless of whether the suture anchor is a hard material suture anchor or a soft material suture anchor, after the suture anchor is implanted into bone, a suture free outside the bone is passed through the soft tissue using a thread guide, the suture is tensioned, and the suture is knotted and fixed on the surface of the soft tissue, thereby repairing the damaged soft tissue.
Therefore, in actual operation, the suture is required to pass through the soft tissue, and then the soft tissue is fixed at the anchoring or operation point by knotting. The method is effective, but as known by people in the industry, when foreign matters in human bodies are recovered at a later stage, connective tissues like bags are usually grown to wrap the foreign matters, the knotting of the suture is equivalent to the foreign matters, and the larger the knot is, the larger the bag is, and the foreign matters are easy to be inflamed.
Example 1
For the reasons described above, with reference to fig. 1, the present embodiment provides a bone implant for soft tissue fixation, comprising a first bone implant 1 and a second bone implant 2, as well as a coupling element 3, the first bone implant 1 comprising a first suture 102 and a first round sheath 101, the first suture 102 being passed through the first round sheath 101;
the second bone implant 2 comprises a second suture 202 and a second round sheath 201, the second suture 202 passing through the second round sheath 201;
after the first and second bone implants 1, 2, respectively, are deployed into bone, the first and second round sheaths 101, 201 are deformed into flexible knots 1', 2', respectively, tightening the first and second sutures 102, 202, respectively, and the coupling element 3 is secured to the bone surface.
The present embodiment provides a bone implant comprising a first bone implant 1 (first anchor), a second bone implant 2 (second anchor) and a coupling element 3 connecting the first bone implant 1 and the second bone implant 2, the first bone implant 1 comprising a first suture 102 and a first round sheath 101 and the second bone implant 2 comprising a second suture 202 and a second round sheath 201. In an actual surgical procedure, two bone marrow tracts are first drilled in the bone of a patient, and one of the two bone tunnels is drilled at least on the bone 5 side with the soft tissue 4, the first bone implant 1 and the second bone implant 2 are implanted in the two bone marrow tracts, respectively, and 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). With first suture 102 threaded through coupling member 3 and free out and second suture 202 threaded through coupling member 3 and free out, the free ends of first suture 102 and second suture 202, respectively, are pulled, allowing coupling member 3 to advance uniformly and eventually secure to the surface of bone 5, achieving a secure attachment of soft tissue 4 to the surface of bone 5, with the excess first suture 102 and second suture 202 sheared off. After the first and second bone implants 1 and 2 are implanted, the coupling elements 3 act as locking fasteners to secure the soft tissue 4 to the bone 5 (as shown in fig. 2), and the first and second sutures 102 and 202 do not need to be tied, thereby achieving a knotting-free effect and avoiding inflammation during the later recovery period.
Meanwhile, 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 can be deformed into the flexible knots 1 'and 2', which illustrates that the bone implant of the embodiment is equivalent to an anchor made of a soft material, and the first round sheath 101 and the second round sheath 201 can be made of materials for making a suture, and meanwhile, a deeper bone marrow channel does not need to be drilled in the bone of a patient, so that the pain of the patient is reduced, and the operation recovery period is also reduced.
It should be noted that, in the prior art, the anchor with thread repairs the soft tissue 4, but there is a problem that the fixing strength is insufficient, and it is necessary to use the anchor without knot in cooperation with the anchor with thread, after the anchor with thread is implanted into the bone, the soft tissue 4 is fixed on the surface of the bone with thread, then a bone marrow channel is drilled at a proper position, the thread is passed through the threading hole of the anchor without knot, and the anchor without knot is implanted into the bone tunnel, and the soft tissue 4 thread is also fixed in the bone. A suture bridge is formed between the suture anchor and the knotless anchor (the suture anchor is generally referred to as an inner row anchor and the knotless anchor is generally referred to as an outer row anchor), and the soft tissue 4 is fixed to the bone surface, but the inner row anchor and the outer row anchor need to be implanted into the bone one after the other.
The bone implant of the present embodiment includes two bone implants, and the first bone implant 1 and the second bone implant 2 are directly and simultaneously implanted, that is, the implantation of the inner row anchors and the outer row anchors is simultaneously achieved, which not only can achieve the repair of the soft tissue 4, but also can greatly reduce the operation time of the operation.
Referring specifically to fig. 1, the bone implant may be a braided wire formed by braiding, and the coupling element 3 is a circular tube on the braided wire, the through holes at both ends of the circular tube being a first hole 301 and a second hole 302, the circular tube dividing the braided wire into a first suture line 102 and a second suture line 202, i.e., the braided wire on both sides of the circular tube being the first suture line 102 and the second suture line 202.
In one embodiment of the embodiment, the first suture line 102 is bent to penetrate into the first hole 301 of the coupling element 3 and then penetrates out of the second hole 302, the first suture line 102 forms a first U-shape, and the first round sheath 101 is arranged at the bottom of the first U-shape in a penetrating manner; second suture 202 is bent to pass through second hole 302 of coupling member 3 and out through first hole 301. Forming a second U-shape, 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 aperture of the suture loop formed by the first suture 102 and the suture loop formed by the second suture 202 can both be reduced, and the linking element 3 is brought closer to the first round sheath 101 and the second round sheath 201.
In another embodiment of this embodiment, referring to fig. 3, coupling member 3 further has a third aperture 303, and first suture 102 is bent to pass through first aperture 301 of coupling member 3 and out of third aperture 303; second suture 202 is bent to pass through second hole 302 of coupling member 3 and out third hole 303, i.e. both first suture 102 and second suture 202 pass out third hole 303, and first suture 102 and second suture 202 may also pass out different holes, i.e. coupling member 3 is further provided with a fourth hole, i.e. first suture 102 is bent to pass through first hole 301 of coupling member 3 and pass out third hole 303; second suture 202 is bent and threaded into second hole 302 of coupling member 3 and threaded out through the fourth hole. With both embodiments, pulling tight on the free ends of the first suture 102 and the free ends of the second suture 202 also allows the linking element 3 to approach the first round sheath 101 and the second round sheath 201.
The braided wire can be braided by ultra-high molecular weight polyethylene fiber or polyester fiber raw material.
In one embodiment of the present embodiment, the first round sheath 101 and the second round sheath 201 are respectively of a braided sleeve structure, 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 cannula structure is circular (shown in fig. 1 and 3) or flat (the first round sheath is shown as an example in fig. 12), but may be other shapes such as square, and the like, which is not limited herein.
In another embodiment of this embodiment, as shown in fig. 13, the first round sheath 101 and the second round sheath 201 may also be configured as a sheet-shaped braided structure, the first round sheath 101 is at least provided with a first threading hole and a second threading hole, and the first suture 102 sequentially passes through the first threading hole and the second threading hole;
the second round sheath 201 is at least provided with a third threading hole and a fourth threading hole, and the second suture 202 sequentially passes through the third threading hole and the fourth threading hole;
the relative movement of the first suture 102 and the first round sheath 101, the second suture 202 and the second round sheath 201 can be generated, and after the first bone implant 1 and the second bone implant 2 are implanted into the bone marrow, the first round sheath 101 and the second round sheath 201 are folded and deformed, and finally, flexible knots 1 'and 2' are formed. Of course, the first circular sheath 101 and the second circular sheath 201 may have three or four threading holes (four threading holes are shown in fig. 13) in addition to two threading holes, which is not described herein.
The first round sheath and the second round sheath, whether in a sleeve configuration or a sheet-like braided configuration, may be both in a sleeve configuration or a sheet-like braided configuration when constructing the first bone implant and the second bone implant; when the first round sheath and the second round sheath are of the sleeve structure, the cross sections of the first round sheath and the second round sheath can be in the same shape or different shapes; when the first round sheath and the second round sheath are of the sheet-shaped braided structure, the first round sheath and the second round sheath are provided with the same number of threading holes, or the first round sheath and the second round sheath can be provided with different numbers of threading holes; the first round sheath and the second round sheath can also be of a sleeve structure and a sheet-shaped braided structure.
Example 2
Since example 1 provides a disposable implantable two full suture anchor, this example provides an inserter 6 applied to example 1 for bone implants for soft tissue 4 fixation, see in particular fig. 4-8, comprising a handle 603 and a first shaft 601 and a second shaft 602, the handle 603, the first shaft 601, the second shaft 602 each 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, as shown in fig. 5, the distal end of the first shaft 601 having a first groove 6011 along the axial direction of the first shaft 601, the distal end of the second shaft 602 having a second groove 6021 along the axial direction of the second shaft 602, the first round sheath 101 in the first bone implant 1 being nested in the first groove 6011, the second round sheath 201 in the second bone implant 2 being nested in the second groove 6021, the first suture 102 and the second suture 202 being pulled, the first round sheath 101 resting in the first groove 6011, the second round sheath 201 resting in the second groove 6021 (see fig. 7).
After the first round sheath 101 and the second round sheath 201 are nested in the first recess 6011 and the second recess 6021, respectively, the coupling element 3 may be fixed to the handle 603 or may be fixed outside the handle 603. Preferably, the coupling element 3 of the bone implant is detachably connected to the handle 603. Referring to fig. 6-7, the free ends of the first suture 102 and the second suture 202 are free outside the inserter 6, and after the coupling element 3 is fixed to the handle 603, the first round sheath 101 and the second round sheath 201 are abutted against the first recess 6011 and the second recess 6021, respectively.
Specifically, the handle 603 includes a first handle 6031 and a second handle 6032, and the joint of the distal ends of the first handle 6031 and the second handle 6032 has a gap where the coupling member 3 is detachably pressed.
The first handle 6031 is provided with a pressing member 604 for controlling the coupling member 3 to be pressed at the gap. Specifically, a third groove 607 is formed in the second handle 6032, an elastic member 606 is arranged in the third groove 607, one end of the elastic member 606 is fixedly connected with the second handle 6032, the other end of the elastic member is fixedly connected with the pressing member 604, the pressing member 604 extends along the axial direction of the inserter 6 to form an extension 6041, and the extension 6041 and the handle 603 are used for pressing the coupling element 3 by extrusion. The pressing member 604 is pressed and the extension 6041 is separated from the handle 603, and the coupling member 3 can be put into the third recess 607, and when the pressing member 604 is released, the elastic member 606 is rebounded and the extension 6041 is brought into contact with the handle 603, and the coupling member 3 can be released from the coupling gap between the first handle 6031 and the second handle 6032 by pressing the pressing member 604 again, and pressing the pressing member 604.
The first shaft 601 and the second shaft 602 may be made of titanium alloy, stainless steel or nickel titanium alloy, which is not limited herein.
Example 3
The present embodiment provides a positioning sleeve 7 applied to the bone implant for soft tissue 4 fixation of embodiment 1 and the inserter 6 described in embodiment 2, and specifically referring to fig. 9, the positioning sleeve 7 comprises a first sleeve 701, a second sleeve 702 and a housing 703, the first sleeve 701 and the second sleeve 702 are fixed in the housing 703, and the first sleeve 701 and the second sleeve 702 are penetratingly disposed in the housing 703, when drilling a bone marrow tract on a bone surface, the positioning sleeve 7 is used for positioning a target position on the bone surface, firstly, a kirschner wire is used for positioning the bone tract at a proper position where the soft tissue 4 needs to be repaired, then, the electric drill is removed, the kirschner wire is retained at the positioning point, then, the kirschner wire of the positioning point is inserted into the first sleeve 701 of the positioning sleeve 7, the positioning sleeve 7 is rotated to find a second position point, then, another kirschner wire is inserted into the second sleeve 702, and another bone marrow tract is drilled by the electric drill. The distance between the first cannula 701 and the second cannula 702 can be specifically set according to different parts or different individual patient soft tissue 4 repairs.
When implanting the bone implant, the k-wires in the first and second sleeves 701, 702 are removed and the first and second shafts 601, 602 of the inserter 6 are inserted into the first and second sleeves 701, 702, respectively (see fig. 10-11).
The material of the first sleeve 701 and the second sleeve 702 may be titanium alloy, stainless steel or nickel titanium alloy, which is not limited herein.
Example 4
Referring to fig. 10-11, the present embodiment provides an implant system for soft tissue 4 fixation comprising the bone implant of embodiment 1, the inserter 6 of embodiment 2 and the positioning sleeve 7 of embodiment 3, wherein the first and second bone implants 1 and 2 of the bone implant are simultaneously implanted into the damaged soft tissue 4 using the inserter 6 and the positioning sleeve 7 to achieve fixation of the soft tissue 4 to the bone surface.
When the positioning sleeve 7 is used for positioning a target position, firstly, an electric drill is used for drilling a marrow channel at a proper position of a soft tissue 4 to be repaired for positioning, then, the electric drill is taken down, the Kirschner wire is kept at the positioning point, then, the Kirschner wire at the positioning point is inserted into the first sleeve 701 of the positioning sleeve 7, the positioning sleeve 7 is rotated to search a second position point, then, the other Kirschner wire is inserted into the second sleeve 702, and the electric drill is used for drilling the other marrow channel;
when the bone implant is implanted, the first bone implant 1 is embedded in the first groove 6011, the second bone implant 2 is embedded in the second groove 6021, then the pressing piece 604 is pressed, the connecting element 3 is embedded in the joint gap of the first handle 6031 and the second handle 6032, then the pressing piece 604 is released, the connecting element 3 is fixed at the joint gap of the first handle 6031 and the second handle 6032, the first suture 102 and the second suture 202 are free outside the handle 603, then the kirschner wires in the first sleeve 701 and the second sleeve 702 are taken out, 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, the proximal end of the handle 603 is knocked by using an instrument until the distal end of the handle 603 contacts the proximal end of the positioning sleeve 7;
taking up the thread, slightly pulling the inserter 6 out for a certain distance, deforming the first round sheath 101 and the second round sheath 201 into flexible knots 1', 2', then pressing the pressing member 604, releasing the coupling element 3, removing the inserter 6 and the positioning sleeve 7, finally uniformly pulling the free ends of the first suture 102 and the second suture 202, uniformly moving the coupling element 3, finally fixing on the surface of the soft tissue 4, and cutting off the redundant first suture 102 and the second suture 202. The final bone implant implanted state in the bone 5 is shown in fig. 2.
The bone implant of the present embodiment is adapted such that at least one bone marrow tract is located on a bone surface having soft tissue 4, and that after implantation of the first and second bone implants 1 and 2, the coupling elements 3 are fixed to the bone surface as snap fasteners, wherein the soft tissue 4 is located at one of the bone surfaces, i.e. the soft tissue 4 is fixed to the bone. Is particularly suitable for the repair operation of the tearing or ripping of the soft tissue 4 from the bone surface.
The embodiments of the present invention have been described in detail with reference to the accompanying drawings, but the present invention is not limited to the above embodiments. Even if various changes are made to the present invention, it is still within the scope of the present invention if they fall within the scope of the claims of the present invention and their equivalents.
Claims (18)
1. A bone implant for soft tissue fixation comprising 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 through which the first suture passes;
the second bone implant comprises a second suture and a second round sheath, the second suture passing through the second round sheath;
said first suture being free from said coupling element through said coupling element after forming a suture loop, said second suture being free from said coupling element through said coupling element after forming a suture loop;
after the first and second bone implants are deployed on the target object, the first and second circular sheaths are deformed into flexible knots to tighten the first and second sutures, respectively, and the coupling element is fixed on the surface of the target object.
2. The bone implant for soft tissue fixation as recited in claim 1, wherein the bone implant is a braided wire formed by braiding, the coupling element is a circular tube on the braided wire, the through holes at both ends of the circular tube are a first hole and a second hole, and the braided wire on both sides of the circular tube is a first suture and a second suture.
3. The bone implant for soft tissue fixation as recited in claim 2, wherein the first suture bend passes into a first aperture of the coupling element and out of a second aperture; the second suture bend passes through a second aperture of the coupling element and out of the first aperture.
4. The bone implant for soft tissue fixation as recited in claim 2, wherein the coupling element further has a third aperture and/or a fourth aperture thereon, the first suture bend passing through the first aperture of the coupling element and out the third aperture or the fourth aperture; the second suture bend passes through the second aperture of the coupling element and out of the third aperture or the fourth aperture.
5. The bone implant for soft tissue fixation as recited in claim 2, wherein the braided wire is braided from an ultra high molecular weight polyethylene or polyester fiber stock.
6. The bone implant for soft tissue fixation according to any one of claims 1-5, wherein the first round sheath and/or the second round sheath are each a braided sleeve structure, the first round sheath being disposed over the first suture and the second round sheath being disposed over the second suture.
7. The bone implant for soft tissue fixation as recited in claim 6, wherein the cannula structure is circular or flat in cross-section.
8. The bone implant for soft tissue fixation according to any one of claims 1 to 5, wherein the first round sheath and/or the second round sheath are each a sheet-like braided structure,
the first round sheath is at least provided with a first threading hole and a second threading hole, and the first suture line sequentially passes through the first threading hole and the second threading hole;
and the second round sheath is at least provided with a third threading hole and a fourth threading hole, and the second thread sequentially penetrates through the third threading hole and the fourth threading hole.
9. An inserter for use in a bone implant for soft tissue fixation as claimed in any of claims 1 to 8, comprising a handle and first and second shafts secured to the handle, the first shaft having a first recess at its distal end and a second recess at its distal end, a first round sheath in the first bone implant resting against the base of the first recess and a second round sheath in the second bone implant resting against the base of the second recess.
10. The inserter of claim 9, wherein the coupling element of the bone implant is detachably connected to the handle, and the free ends of the first and second sutures are free outside the inserter.
11. The inserter according to claim 10, wherein the handle comprises a first handle and a second handle, and the coupling member is removably pressed at a distal junction of the first and second handles.
12. Inserter according to claim 10 or 11, characterized in that a pressing member is arranged on the first handle for controlling the pressing of the coupling element at the slit.
13. An inserter according to claim 12, wherein a resilient member is provided in the second handle, the resilient member having one end secured to the second handle and the other end secured to the pressing member, the pressing member extending axially of the inserter to form an extension which presses the coupling element with the handle by squeezing action.
14. The inserter of claim 9, wherein the first shaft and the second shaft are each titanium alloy, stainless steel, or nitinol.
15. A positioning sleeve for use with a bone implant for soft tissue fixation according to any one of claims 1 to 8 and an inserter according to any one of claims 9 to 14, wherein the positioning sleeve comprises a first sleeve, a second sleeve and a housing, the first and second sleeves being fixed within the housing, the positioning sleeve being for positioning a target site on a target;
the first and second shafts of the inserter are inserted into and out of the first and second cannulae, respectively.
16. The positioning sleeve of claim 15, wherein the first sleeve and the second sleeve are made of titanium alloy, stainless steel or nickel-titanium alloy.
17. An implant system for soft tissue fixation, comprising a bone implant for soft tissue fixation according to any one of claims 1 to 8, an inserter according to any one of claims 9 to 14 and a positioning sleeve according to claim 14 or 15, the positioning sleeve being for positioning a target site on a target object, the inserter being for driving deployment of the bone implant within the target object.
18. The soft tissue fixation implant system as recited in claim 17, wherein the positioning sleeve locates the target site, the first bone implant is nested within the first recess, the second bone implant is nested within the second recess, the first and second shafts are inserted into the first and second sleeves, respectively, and the inserter is stroked until the distal end of the handle contacts the proximal end of the positioning sleeve, the first and second bone implants being deployed into the target subject, respectively;
withdrawing a portion of the inserter, deforming and shrinking the first round sheath and the second round sheath to form a flexible knot, completely withdrawing the inserter and the positioning sleeve, respectively pulling the free ends of the first suture and the second suture, and fixing the coupling element on the surface of the target object.
Priority Applications (2)
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CN202211406025.2A CN115778457A (en) | 2022-11-10 | 2022-11-10 | Bone implant, positioning sleeve, inserter and implantation system |
PCT/CN2023/126177 WO2024099065A1 (en) | 2022-11-10 | 2023-10-24 | Bone implant, positioning sleeve, inserter, and implantation system |
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Cited By (1)
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WO2024099065A1 (en) * | 2022-11-10 | 2024-05-16 | 上海利格泰生物科技股份有限公司 | Bone implant, positioning sleeve, inserter, and implantation system |
Family Cites Families (10)
Publication number | Priority date | Publication date | Assignee | Title |
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US20170055975A1 (en) * | 2015-09-02 | 2017-03-02 | Raymond Thal | Adjustable, locking all-suture anchor assembly and method for repair |
CN207545268U (en) * | 2017-04-18 | 2018-06-29 | 上海利格泰生物科技有限公司 | The graft Suspending fixation device of adjustable in length |
CN207575224U (en) * | 2018-05-31 | 2018-07-06 | 上海凯利泰医疗科技股份有限公司 | A kind of shoulder joint bone grafting device |
CN109223076A (en) * | 2018-09-28 | 2019-01-18 | 北京市春立正达医疗器械股份有限公司 | Pre-knotted holdfast and its implanted device |
CN110215247A (en) * | 2019-06-25 | 2019-09-10 | 上海利格泰生物科技有限公司 | The more suture holdfasts of circle sheath and implanted device |
CN110215245A (en) * | 2019-06-25 | 2019-09-10 | 上海利格泰生物科技有限公司 | Circle sheath suture holdfast and implanted device |
CN210811258U (en) * | 2019-08-26 | 2020-06-23 | 上海大博医疗科技有限公司 | Full suture anchor |
CN216021207U (en) * | 2021-07-31 | 2022-03-15 | 江苏爱厚朴医疗器械有限公司 | Knotting-free full suture anchor |
CN115153799A (en) * | 2022-07-11 | 2022-10-11 | 重庆熙科医疗科技有限公司 | Adjustable flexible bone-to-bone fixing device and implanting mechanism |
CN115778457A (en) * | 2022-11-10 | 2023-03-14 | 上海利格泰生物科技有限公司 | Bone implant, positioning sleeve, inserter and implantation system |
-
2022
- 2022-11-10 CN CN202211406025.2A patent/CN115778457A/en active Pending
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WO2024099065A1 (en) * | 2022-11-10 | 2024-05-16 | 上海利格泰生物科技股份有限公司 | Bone implant, positioning sleeve, inserter, and implantation system |
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