WO2024099065A1 - 一种骨植入物、定位套管、***器及植入*** - Google Patents
一种骨植入物、定位套管、***器及植入*** Download PDFInfo
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- WO2024099065A1 WO2024099065A1 PCT/CN2023/126177 CN2023126177W WO2024099065A1 WO 2024099065 A1 WO2024099065 A1 WO 2024099065A1 CN 2023126177 W CN2023126177 W CN 2023126177W WO 2024099065 A1 WO2024099065 A1 WO 2024099065A1
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- Prior art keywords
- suture
- bone implant
- sleeve
- hole
- bone
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- 210000000988 bone and bone Anatomy 0.000 title claims abstract description 221
- 239000007943 implant Substances 0.000 title claims abstract description 166
- 238000002513 implantation Methods 0.000 title abstract description 13
- 210000004872 soft tissue Anatomy 0.000 claims abstract description 67
- 230000008878 coupling Effects 0.000 claims description 59
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- 238000005859 coupling reaction Methods 0.000 claims description 59
- 229910001069 Ti alloy Inorganic materials 0.000 claims description 9
- 239000000835 fiber Substances 0.000 claims description 8
- 229910001000 nickel titanium Inorganic materials 0.000 claims description 6
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- 229910001256 stainless steel alloy Inorganic materials 0.000 claims description 6
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- 101100012902 Saccharomyces cerevisiae (strain ATCC 204508 / S288c) FIG2 gene Proteins 0.000 description 2
- JUPQTSLXMOCDHR-UHFFFAOYSA-N benzene-1,4-diol;bis(4-fluorophenyl)methanone Chemical compound OC1=CC=C(O)C=C1.C1=CC(F)=CC=C1C(=O)C1=CC=C(F)C=C1 JUPQTSLXMOCDHR-UHFFFAOYSA-N 0.000 description 2
- 210000002808 connective tissue Anatomy 0.000 description 2
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Classifications
-
- 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
-
- 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
Definitions
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- the second suture forms a suture loop and passes through the coupling element to be free outside the coupling element
- 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.
- 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
- the braided wires on both sides of the round tube are the first suture and the second suture.
- 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.
- 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.
- the braided wire is braided from ultra-high molecular weight polyethylene fiber or polyester fiber raw material.
- 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.
- the cross section of the sleeve structure is circular or flat.
- 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.
- 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.
- 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.
- a pressing piece is provided on the first handle for controlling the coupling element to be pressed at the gap.
- 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.
- 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.
- 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 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
- the second suture forms a suture loop and passes through the coupling element to be free outside the coupling element
- 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.
- 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
- the braided wires on both sides of the round tube are the first suture and the second suture.
- 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.
- 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.
- the braided wire is braided from ultra-high molecular weight polyethylene fiber or polyester fiber raw material.
- 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.
- the cross section of the sleeve structure is circular or flat.
- 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 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.
- 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.
- 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.
- 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.
- 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.
- a Kirschner wire is used to punch a medullary canal in the bone.
- 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.
- the first sleeve is inserted, the positioning sleeve is rotated, and a second position point is found.
- another Kirschner wire is inserted into the second sleeve to punch a second medullary canal.
- 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.
- 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.
- 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;
- Example 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.
- 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.
- 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.
- horizontal does not mean that the components are required to be absolutely horizontal or suspended, but can be slightly tilted.
- 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.
- proximal end refers to the end close to the operator
- distal end refers to the end far from the operator
- 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.
- 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.
- 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.
- 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
- the second bone implant 2 includes a second suture 202 and a second round sheath 201.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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
- the braided wire can be braided from ultra-high molecular weight polyethylene fiber or polyester fiber raw material.
- 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.
- 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'.
- 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.
- the first round sheath and the second round sheath can be both a sleeve structure or a sheet-like woven structure.
- 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.
- 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
- 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).
- the connecting element 3 can be fixed on the handle 603 or fixed outside the handle 603.
- 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.
- 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.
- 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.
- the elastic member 606 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.
- 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.
- the positioning sleeve 7 is used to locate the target position on the bone surface.
- 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.
- 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.
- 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.
- the positioning sleeve 7 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;
- 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;
- 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 bone implant of this embodiment is suitable for at least one medullary canal on the bone surface with soft tissue 4.
- 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.
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Abstract
一种用于软组织(4)固定的骨植入物、定位套管(7)、***器(6)及植入***,骨植入物包括第一骨植入物(1)和第二骨植入物(2)以及联结元件(3),第一骨植入物(1)包括第一缝线(102)和第一圆鞘(101),第一缝线(102)穿过第一圆鞘(101);第二骨植入物(2)包括第二缝线(202)和第二圆鞘(201),第二缝线(202)穿过第二圆鞘(201);第一缝线(102)形成缝线环后穿过联结元件(3)游离在联结元件(3)外,第二缝线(202)形成缝线环后穿过联结元件(3)游离在联结元件(3)外;第一骨植入物(1)和第二骨植入物(2)分别被配置目标对象后,第一圆鞘(101)和第二圆鞘(201)形变为柔性结(1',2'),分别收紧第一缝线(102)和第二缝线(202),联结元件(3)固定在目标对象表面。可同时将两个骨植入物(1,2)植入骨(5)中,实现软组织(4)固定,同时两个骨植入物(1,2)采用两个联结元件(3)连接,无需在骨面上打结。
Description
本发明属于医疗器械技术领域,尤其涉及一种用于软组织固定的骨植入物、定位套管、***器及植入***。
近年来,以钛合金、PEEK和聚乳酸材料为材质的带线锚钉技术广泛用于软组织与骨组织连接处损伤的修复,如:肩袖损伤,盂唇损伤,股骨近端肌腱损伤,肩关节上盂唇前后部的损伤,尺侧副韧带损伤重建,肱二头肌远端肌腱损伤,舟月骨间韧带修复,三角纤维软骨修复,伸指肌腱损伤修复等。这类硬质锚钉类似螺丝钉旋于需要固定部位附近的骨组织上,锚钉上预载的缝线穿过需要修复的软组织,通过捆绑拉紧缝线将软组织与骨组织表面接触固定,完成受损组织的物理修复。
随着硬材质锚钉技术应用日趋广泛,硬材质锚钉已知存在很多缺陷:钛合金金属锚钉植入后容易因排异反应发生炎症,造成植入部位发生骨溶解,引发锚钉松动、移位,造成固定失败。PLA类可吸收锚钉植入后可能会过早降解和破碎,继发锚钉移位导致固定牢固度下降,降解物可能导致滑膜炎,骨溶解等问题。尽管PEEK材质的带线锚钉解决了钛合金锚钉植入后容易松动、移位等问题,也解决了可吸收材质的锚钉植人后破裂或过早降解,继发移位导致固定牢固度下降,降解物容易导致滑膜炎,骨溶解等问题,但是仍然存在锚钉植入部位骨道较大,致使骨去除量较大,容易发生骨折或者骨破裂等问题。此外,硬材质锚钉植入后一旦从骨道脱离,硬质锚钉会对附近关节组织和骨表面造成损伤;硬质锚钉返修不但非常困难而且会对病人造成很大痛苦。
为了解决硬材质锚钉存在的问题,出现了全缝线锚钉产品。该产品锚钉部分采用可以用来制作缝线的材料制成。具有以下优点:软材料锚钉可以任意改变形状,固定时所需的骨道小,骨移除量少;容易移除和返修,返修时可稍微扩大骨道,换用硬材质锚钉;即便软材质的全缝线锚钉植入后从骨道中脱出,不会对周围关节和骨表面造成损伤。
不管是硬质锚钉还是软质带线锚钉,在实际手术时,缝线均需先与软组织捆绑,然后通过打结的方式将软组织固定于锚固出或手术点。该方式固然有效,但业内人士都知道,人体内有异物在后期恢复时,通常会长出“包”一样的***对异物进行包裹,缝线打结相当于异物,打结越大“包”越大,且容易发炎。
发明内容
为解决上述的技术问题,本发明提供了一种用于软组织固定的骨植入物、定位套管、***器及植入***,本发明提供的骨植入物可同时将两个骨植入物植入骨中,实现软组织固定,同时两个骨植入物采用两个联结元件连接,无需在骨面上打结。
为实现上述目的,本发明的技术方案为:
一种用于软组织固定的骨植入物,包括第一骨植入物和第二骨植入物以及联结元件,所述第一骨植入物包括第一缝线和第一圆鞘,所述第一缝线穿过所述第一圆鞘;
所述第二骨植入物包括第二缝线和第二圆鞘,所述第二缝线穿过所述第二圆鞘;
所述第一缝线形成缝线环后穿过所述联结元件游离在所述联结元件外,所述第二缝线形成缝线环后穿过所述联结元件游离在所述联结元件外;
所述第一骨植入物和第二骨植入物分别被配置目标对象后,所述第一圆鞘和第二圆鞘形变为柔性结,分别收紧第一缝线和第二缝线,联结元件固定
在目标对象表面。
本发明一实施方式中,所述骨植入物为编织形成的编织线,所述联结元件为所述编织线上的圆管,所述圆管两端的通孔为第一孔和第二孔,所述圆管两侧的编织线为第一缝线和第二缝线。
本发明一实施方式中,所述第一缝线折弯穿入所述联结元件的第一孔,从所述第二孔穿出;所述第二缝线折弯穿入所述联结元件的第二孔,从所述第一孔穿出。
本发明一实施方式中,所述联结元件上还具有第三孔和/或第四孔,所述第一缝线折弯穿入所述联结元件的第一孔,从所述第三孔或第四孔穿出;所述第二缝线折弯穿入所述联结元件的第二孔,从所述第三孔或第四孔穿出。
本发明一实施方式中,所述编织线为超高分子量聚乙烯纤维或聚酯纤维原料编织而成。
本发明一实施方式中,所述第一圆鞘和/或第二圆鞘分别为编织形成的套管结构,所述第一圆鞘套设在所述第一缝线上,所述第二圆鞘套设在所述第二缝线上。
本发明一实施方式中,所述套管结构的横截面为圆形或扁形状。
本发明一实施方式中,所述第一圆鞘和/或第二圆鞘均为片状编织结构,
所述第一圆鞘上至少开设有第一穿线孔和第二穿线孔,所述第一缝线依次穿过所述第一穿线孔和第二穿线孔;
所述第二圆鞘上至少开设有第三穿线孔和第四穿线孔,所述第二缝线依次穿过所述第三穿线孔和第四穿线孔。
本发明还提供了一种***器,应用于上述的用于软组织固定的骨植入物,包括手柄和第一轴和第二轴,所述第一轴和第二轴固定于所述手柄,所述第一轴的远端具有沿第一轴轴向的第一凹槽,所述第二轴的远端具有沿第二轴轴向的第二凹槽,第一骨植入物中第一圆鞘嵌设在所述第一凹槽内,所述第二骨植入物中第二圆鞘嵌设在所述第二凹槽内,牵拉所述第一缝线和第二缝
线,所述第一圆鞘抵靠在第一凹槽内,第二圆鞘抵靠在所述第二凹槽内。
本发明一实施方式中,所述骨植入物的联结元件可拆卸地连接于所述手柄,第一缝线和第二缝线的游离端游离在所述***器外,联结元件固定在手柄处后,第一圆鞘和第二圆鞘分别抵靠在第一凹槽和第二凹槽内。
本发明一实施方式中,所述手柄包括第一手柄和第二手柄,所述第一手柄和第二手柄远端结合处具有缝隙,所述联结元件可拆卸地压制在所述缝隙处。
本发明一实施方式中,所述第一手柄上设置按压件,用于控制所述联结元件压制于所述缝隙处。
本发明一实施方式中,所述第二手柄内开设第三凹槽,所述第三凹槽内设置弹性件,所述弹性件的一端固连所述第二手柄,另一端固连所述按压件,所述按压件沿所述***器的轴向延伸,形成延伸部,所述延伸部与所述手柄通过挤压压制所述联结元件。
本发明一实施方式中,所述第一轴和第二轴的材质为钛合金、不锈钢或镍钛合金。
本发明还提供了一种定位套管,应用于上述的用于软组织固定的骨植入物和上述的***器,所述定位套管包括第一套管、第二套管和外壳,所述第一套管和第二套管固定于所述外壳内,所述定位套管用于在目标对象上定位目标位置;
所述***器的第一轴和第二轴分别***所述第一套管和第二套管,并穿出所述第一套管和第二套管。
本发明一实施方式中,所述第一套管和第二套管的材质为钛合金、不锈钢或镍钛合金。
本发明还提供了一种软组织固定的植入***,包括上述的骨植入物、上述的***器和上述的定位套管,所述定位套管用于在目标对象上定位目标位置,所述***器用于将所述骨植入物配置在所述目标对象内;
骨植入物包括第一骨植入物和第二骨植入物以及联结元件,所述第一骨植入物包括第一缝线和第一圆鞘,所述第一缝线穿过所述第一圆鞘;
所述第二骨植入物包括第二缝线和第二圆鞘,所述第二缝线穿过所述第二圆鞘;
所述第一缝线形成缝线环后穿过所述联结元件游离在所述联结元件外,所述第二缝线形成缝线环后穿过所述联结元件游离在所述联结元件外;
所述***器包括手柄和第一轴和第二轴,所述第一轴和第二轴固定于所述手柄,所述第一轴的远端具有沿第一轴轴向的第一凹槽,所述第二轴的远端具有沿第二轴轴向的第二凹槽,第一骨植入物中第一圆鞘嵌设在所述第一凹槽内,所述第二骨植入物中第二圆鞘嵌设在所述第二凹槽内,牵拉所述第一缝线和第二缝线,所述第一圆鞘抵靠在第一凹槽内,第二圆鞘抵靠在所述第二凹槽内。
所述定位套管包括第一套管、第二套管和外壳,所述第一套管和第二套管固定于所述外壳内,所述定位套管用于在目标对象上定位目标位置;
所述定位套管在目标对象表面定位目标位置,第一骨植入物嵌设在所述第一凹槽内,第二骨植入物嵌设在所述第二凹槽内,第一轴和第二轴分别***所述第一套管和第二套管,直到手柄远端接触所述定位套管的近端,第一骨植入物和第二骨植入物分别被配置到目标对象内,抽离所述***器,所述第一圆鞘和第二圆鞘均形变收缩形成柔性结,所述***器和定位套管完全抽离,分别牵拉第一缝线和第二缝线的游离端,联结元件固定在目标对象表面。
本发明一实施方式中,所述骨植入物为编织形成的编织线,所述联结元件为所述编织线上的圆管,所述圆管两端的通孔为第一孔和第二孔,所述圆管两侧的编织线为第一缝线和第二缝线。
本发明一实施方式中,所述第一缝线折弯穿入所述联结元件的第一孔,从所述第二孔穿出;所述第二缝线折弯穿入所述联结元件的第二孔,从所述第一孔穿出。
本发明一实施方式中,所述联结元件上还具有第三孔和/或第四孔,所述第一缝线折弯穿入所述联结元件的第一孔,从所述第三孔或第四孔穿出;所述第二缝线折弯穿入所述联结元件的第二孔,从所述第三孔或第四孔穿出。
本发明一实施方式中,所述编织线为超高分子量聚乙烯纤维或聚酯纤维原料编织而成。
本发明一实施方式中,所述第一圆鞘和/或第二圆鞘分别为编织形成的套管结构,所述第一圆鞘套设在所述第一缝线上,所述第二圆鞘套设在所述第二缝线上。
本发明一实施方式中,所述套管结构的横截面为圆形或扁形状。
本发明一实施方式中,所述第一圆鞘/或第二圆鞘均为片状编织结构,
所述第一圆鞘上至少开设有第一穿线孔和第二穿线孔,所述第一缝线依次穿过所述第一穿线孔和第二穿线孔;
所述第二圆鞘上至少开设有第三穿线孔和第四穿线孔,所述第二缝线依次穿过所述第三穿线孔和第四穿线孔。
本发明由于采用以上技术方案,使其与现有技术相比具有以下的优点和积极效果:
本发明提供的骨植入物,包括第一骨植入物、第二骨植入物以及连接第一骨植入物和第二骨植入物的联结元件,第一骨植入物包括第一缝线和第一圆鞘,第二骨植入物包括第二缝线和第二圆鞘,第一骨植入物和第二骨植入物分别植入各自骨隧道内,且两个骨髓道至少一个是在具有软组织的骨头上打出,分别抽拉第一缝线和第二缝线,第一圆鞘和第二圆鞘分别在骨中内形成柔性结。另外由于第一缝线和第二缝线均穿过联结元件,因此在第一骨植入物和第二骨植入物后,再次抽拉第一缝线和第二缝线,联结元件也固定在骨上,且联结元件相当于锁扣,将软组织固定在骨表面,而无需在软组织外打结,达到免打结效果。
本发明提供的骨植入物可代替传统的带线锚钉功能,实现内外排锚钉同
时固定,骨植入物植入骨中后减掉多余第一缝线和第二缝线,不仅实现免打结的效果,还可以同时植入内排锚钉和外排锚钉,大幅度减少手术操作时间。
本发明由于采用联结元件将第一骨植入物和第二骨植入物连接,在第一骨植入物和第二骨植入物植入骨中后,收紧第一缝线和第二缝线后,联结元件将软组织固定在骨表面,同时联结元件也固定在骨表面。因此本发明的骨植入物直接用于软组织固定,可以迅速将软组织固定到骨表面。另第一骨植入物和第二骨植入物植入骨中后可变形成柔性结,因此本发明的两个骨植入物也替代了全缝线锚钉功能。
本发明还提供了驱动本发明骨植入物的***器,***器包括手柄和第一轴和第二轴,第一轴和第二轴均固定在手柄的远端,骨植入物的第一圆鞘嵌设在第一轴远端的第一凹槽,第二圆鞘嵌设在第二轴远端的第二凹槽,连接第一骨植入物和第二骨植入的联结元件优选可拆卸地压制在手柄处,第一缝线和第二缝线游离在手柄外。优选采用按压件控制联结元件是否压制在手柄处。敲击手柄的近端,可将第一骨植入物和第二骨植入物植入到骨内。
本发明还提供了定位套管,用于在骨表面定位打合适的骨髓道,定位导管包括第一套管和第二套管,一般采用克氏针在骨中打骨髓道,先采用一根克氏针在患者合适位置打孔定位,然后将克氏针保留在定位点,然后***第一套管,旋转定位套管,寻找第二个位置点,然后将另一根克氏针***第二套管内打第二个骨髓道。在骨植入物植入过程中,第一骨植入物和第二骨植入物分别安装到第一轴和第二轴后,取出第一套管和第二套管内的克氏针,将第一轴和第二轴分别***第一套管和第二套管内,敲击***器的近端,直到***器手柄的远端接触定位套管的近端,此时将第一骨植入物和第二骨植物植入骨隧道内,然后将***器从定位套管内拔出一端距离,使第一圆鞘和第二圆鞘形变成柔性结,然后释放联结元件,取出***器和定位套管,牵拉第一缝线和第二缝线,使联结元件固定在骨表面,最终实现将软组织固定在骨表面。
图1为本发明实施例1用于软组织固定的骨植入物的一种实施方式结构图;
图2为本发明实施例1用于软组织固定的骨植入物植入骨中后的状态示意图;
图3为本发明实施例1用于软组织固定的骨植入物的另一种实施方式结构图;
图4为本发明实施例2***器的结构示意图;
图5为图4中A部分的放大图;
图6为本发明实施例2***器与骨植入物装配后的结构示意图;
图7为图6中B部分的放大图;
图8为本发明实施例2***器手柄处的剖面图;
图9为本发明实施例3的定位套管的结构示意图;
图10为本发明实施例4的植入***的结构示意图一;
图11为本发明实施例4的植入***的结构示意图二;
图12为本发明实施例1用于软组织固定的骨植入物中的第一圆鞘或第二圆鞘为扁形状的示意图;
图13为本发明实施例1用于软组织固定的骨植入物中的第一圆鞘或第二圆鞘为片状编织结构的示意图。
以下结合附图和具体实施例对本发明提出的一种用于软组织固定的骨植入物、定位套管、***器及植入***作进一步详细说明。根据下面说明,本发明的优点和特征将更清楚。显然,所描述的实施例是本发明一部分实施例,而不是全部的实施例。通常在此处附图中描述和示出的本发明实施例的组件可以以各种不同的配置来布置和设计。
因此,以下对在附图中提供的本发明的实施例的详细描述并非旨在限制要求保护的本发明的范围,而是仅仅表示本发明的选定实施例。基于本发明中的实施例,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
应注意到:相似的标号在下面的附图中表示类似项,因此,一旦某一项在一个附图中被定义,则在随后的附图中不需要对其进行进一步定义和解释。
在本发明的描述中,需要说明的是,术语“中心”、“上”、“下”、“左”、“右”、“竖直”、“水平”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系,或者是该发明产品使用时惯常摆放的方位或位置关系,仅是为了便于描述本发明和简化描述,而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作,因此不能理解为对本发明的限制。此外,术语“第一”、“第二”、“第三”等仅用于区分描述,而不能理解为指示或暗示相对重要性。
此外,术语“水平”、“竖直”等术语并不表示要求部件绝对水平或悬垂,而是可以稍微倾斜。如“水平”仅仅是指其方向相对“竖直”而言更加水平,并不是表示该结构一定要完全水平,而是可以稍微倾斜。
在本申请描述中,“近端”为靠近操作者的一端,“远端”为远离操作者的一端。
需要说明的是,作为广泛用于软组织与骨组织连接处损伤的修复的带线锚钉,无论是硬质材质的带线锚钉,还是软质材质的带线锚钉,带线锚钉植入骨中后,采用引线器将游离在骨外的缝线穿过软组织,拉紧缝线并将在软组织的表面上缝线打结固定,实现受损软组织的修复。
因此在实际手术时,缝线均需先穿过软组织,然后通过打结的方式将软组织固定于锚固出或手术点。该方式固然有效,但业内人士都知道,人体内有异物在后期恢复时,通常会长出“包”一样的***对异物进行包裹,缝线打结相当于异物,打结越大“包”越大,且容易发炎。
实施例1
基于上述的原因,参看图1,本实施例提供了一种用于软组织固定的骨植入物,包括第一骨植入物1和第二骨植入物2以及联结元件3,第一骨植入物1包括第一缝线102和第一圆鞘101,第一缝线102穿过第一圆鞘101;
第二骨植入物2包括第二缝线202和第二圆鞘201,第二缝线202穿过第二圆鞘201;
第一缝线102形成缝线环后穿过联结元件3游离在联结元件3外,第二缝线202形成缝线环后穿过联结元件3游离在联结元件3外;
第一骨植入物1和第二骨植入物2分别被配置骨中后,第一圆鞘101和第二圆鞘201形变为柔性结1’、2’,分别收紧第一缝线102和第二缝线202,联结元件3固定在骨表面。
本实施例提供的骨植入物,包括了第一骨植入物1(第一锚钉)、第二骨植入物2(第二锚钉)以及将第一骨植入物1和第二骨植入物2连接的联结元件3,第一骨植入物1包括第一缝线102和第一圆鞘101,第二骨植入物2包括第二缝线202和第二圆鞘201。在实际的手术过程中,首先是在患者的骨中打出两个骨髓道,并且两个骨隧道中的一个至少是在具有软组织4的骨5面上打出的,将第一骨植入物1和第二骨植物物2分别植入两个骨髓道内,第一骨植入物1和第二骨植入物2植入后,第一圆鞘101和第二圆鞘201形变为柔性结1’、2’(如图2所示)。由于第一缝线102穿过联结元件3并游离在外,第二缝线202穿过联结元件3并游离在外,分别牵拉第一缝线102和第二缝线202的游离端,使联结元件3均匀前移,最终固定在骨5表面,实现将软组织4固定在骨5表面,剪掉多余的第一缝线102和第二缝线202。第一骨植入物1和第二骨植入物2植入完成后,联结元件3相当于锁扣,将软组织4固定在骨5表面(如图2所示),第一缝线102和第二缝线202也无需打结,实现了免打结的效果,进而避免了后期恢复期的发炎。
同时,在第一骨植入物1和第二骨植入物2植入后,第一圆鞘101和第
二圆鞘201可变形为柔性结1’、2’,说明本实施例的骨植入物相当于软质材料的锚钉,第一圆鞘101和第二圆鞘201可以用来制作缝线的材料制成,同时无需在患者骨中打较深的骨髓道,对于患者来说,减小的痛苦,也减小了手术恢复期。
需要说明的是,在现有技术中,带线锚钉修复软组织4,但存在固定强度不足的问题,需要使用无结锚钉与带线锚钉配合使用,带线锚钉植入骨中后,用缝线将软组织4固定在骨表面,然后在合适的位置再打一个骨髓道,将缝线穿入无结锚钉的穿线孔中,无结锚钉被植入骨隧道的同时,软组织4缝线也被固定在骨中。带线锚钉和无结锚钉两者之间形成缝线桥(带线锚钉通常意义上称为内排锚钉,无结锚钉通常意义上称为外排锚钉),将软组织4固定在骨表面,但是需要先后将内排锚钉和外排锚钉先后植入骨中。
而作为本实施例的骨植入物,具有两个骨植入物,直接同时植入第一骨植入物1和第二骨植入物2,即同时实现内排锚钉和外排锚钉的植入,既能实现软组织4的修复,还能大幅度减少手术操作时间。
具体参看图1,骨植入物可以为编织形成的编织线,联结元件3为编织线上的圆管,圆管两端的通孔为第一孔301和第二孔302,圆管将编织线分为第一缝线102和第二缝线202,即圆管两侧的编织线为第一缝线102和第二缝线202。
本实施例的一个实施方式中,第一缝线102折弯穿入联结元件3的第一孔301,从第二孔302穿出,第一缝线102形成第一U型,第一圆鞘101穿设在第一U型底部;第二缝线202折弯穿入联结元件3的第二孔302,从第一孔301穿出。形成第二U型,第二圆鞘201穿设在第二U型的底部。牵拉第一缝线102和第二缝线202的游离端,第一缝线102形成的缝线环和第二缝线202形成的缝线环的孔径均可减小,联结元件3向第一圆鞘101和第二圆鞘201靠近。
本实施例的另一实施方式中,参看图3,联结元件3上还具有第三孔303,
第一缝线102折弯穿入联结元件3的第一孔301,从第三孔303穿出;第二缝线202折弯穿入联结元件3的第二孔302,从第三孔303穿出,即第一缝线102和第二缝线202均从第三孔303穿出,第一缝线102和第二缝线202也可从不同的孔穿出,即在联结元件3还具有第四孔,即第一缝线102折弯后穿入联结元件3的第一孔301,从第三孔303穿出;第二缝线202折弯后穿入联结元件3的第二孔302,从第四孔穿出。采用两种实施方式,牵拉紧第一缝线102的游离端和第二缝线202的游离端,也可实现联结元件3向第一圆鞘101和第二圆鞘201靠近。
编织线可以为超高分子量聚乙烯纤维或聚酯纤维原料编织而成。
本实施例的一个实施方式中,第一圆鞘101和第二圆鞘201分别为编织形成的套管结构,第一圆鞘101套设在第一缝线102上,第二圆鞘201套设在第二缝线202上。套管结构的横截面为圆形(图1和3示出)或扁形状(图12中以第一圆鞘为例示出),当然也可以为正方形等其他形状,在此不做限制。
本实施例的另一实施方式中,如图13所示,第一圆鞘101和第二圆鞘201也可以构造为片状编织结构,第一圆鞘101上至少开设有第一穿线孔和第二穿线孔,第一缝线102依次穿过第一穿线孔和第二穿线孔;
第二圆鞘201上至少开设有第三穿线孔和第四穿线孔,第二缝线202依次穿过第三穿线孔和第四穿线孔;
第一缝线102和第一圆鞘101、第二缝线202和第二圆鞘201可发生相对的移动,第一骨植入物1和第二骨植入物2植入骨髓道后,第一圆鞘101和第二圆鞘201发生折叠变形,最终形成柔性结1’、2’。当然第一圆鞘101和第二圆鞘201上除了具有两个穿线孔,也可具有三个、四个穿线孔等(图13展示的具有四个穿线孔),在此不做赘述。
第一圆鞘和第二圆鞘无论是套管结构或片状的编织结构,在构成第一骨植入物和第二骨植入物时,第一圆鞘和第二圆鞘可以同时为套管结构或片状
的编织结构;在同为套管结构时,第一圆鞘和第二圆鞘的横截面的形状可以为相同形状,也可以为不同形状;在同为片状的编织结构时,第一圆鞘和第二圆鞘上具有的相同数量的穿线孔,也可为不同数量的穿线孔;第一圆鞘和第二圆鞘也可以为套管结构和片状的编织结构。
实施例2
由于实施例1提供了一次性可植入两个全缝线锚钉,因此本实施例提供一种应用于实施例1用于软组织4固定的骨植入物的***器6,具体参看图4-8,包括手柄603和第一轴601和第二轴602,手柄603、第一轴601、第二轴602均具有近端和远端,第一轴601的远端和第二轴602的远端固定于手柄603,参看图5所示,第一轴601的远端具有沿第一轴601轴向的第一凹槽6011,第二轴602的远端具有沿第二轴602轴向的第二凹槽6021,第一骨植入物1中第一圆鞘101嵌设在第一凹槽6011内,第二骨植入物2中第二圆鞘201嵌设在第二凹槽6021内,牵拉第一缝线102和第二缝线202,第一圆鞘101抵靠在第一凹槽6011内,第二圆鞘201抵靠在第二凹槽6021内(参看图7)。
第一圆鞘101和第二圆鞘201分别嵌设在第一凹槽6011和第二凹槽6021内后,联结元件3可以固定在手柄603上,也可以在手柄603外固定,优选地,骨植入物的联结元件3可拆卸地连接于手柄603,参看图6-7,第一缝线102和第二缝线202的游离端游离在***器6外,联结元件3固定在手柄603后,第一圆鞘101和第二圆鞘201分别抵靠在第一凹槽6011和第二凹槽6021内。
具体地,手柄603包括第一手柄6031和第二手柄6032,第一手柄6031和第二手柄6032远端结合处具有缝隙,联结元件3可拆卸地压制在缝隙处。
第一手柄6031上设置按压件604,用于控制联结元件3压制于缝隙处。具体在第二手柄6032内开设第三凹槽607,在第三凹槽607内设置弹性件606,
弹性件606的一端固连第二手柄6032,另一端固连按压件604,按压件604沿***器6的轴向延伸,形成延伸部6041,延伸部6041与手柄603通过挤压压制联结元件3。按压按压件604,延伸部6041与手柄603分开,此时可将联结元件3放入第三凹槽607内,松开按压件604后,弹性件606回弹,延伸部6041与手柄603接触,通过挤压压制住联结元件3,再次按压按压件604,可将联结元件3从第一手柄6031和第二手柄6032的结合缝隙处释放。
第一轴601和第二轴602的材质可以为钛合金、不锈钢或镍钛合金,在此不做限制。
实施例3
本实施例提供了一种定位套管7,应用于实施例1的用于软组织4固定的骨植入物,以及实施例2所述的***器6,具体参看图9,定位套管7包括第一套管701、第二套管702和外壳703,第一套管701和第二套管702固定于外壳703内,且第一套管701和第二套管702贯穿设置在外壳703内,在骨表面打骨髓道时,定位套管7用于在骨表面上定位目标位置,首先使用电钻,将一根克氏针,在需要修复软组织4的合适位置打骨髓道定位,然后取下电钻,将克氏针保留在定位点,然后将定位点的克氏针***定位套管7的第一套管701,旋转定位套管7,寻找第二个位置点,然后将另一个克氏针***第二套管702内,使用电钻打另一个骨髓道。第一套管701和第二套管702的距离可根据不同部位或不同患者个体软组织4修复进行具体设置。
在植入骨植入物时,取出第一套管701和第二套管702内的克氏针,***器6的第一轴601和第二轴602分别***第一套管701和第二套管702(参看图10-11)。
第一套管701和第二套管702的材质可以为钛合金、不锈钢或镍钛合金,在此不做限制。
实施例4
参看图10-11,本实施例提供了一种软组织4固定的植入***,包括实
施例1的骨植入物、实施例2的***器6和实施例3的定位套管7,采用***器6和定位套管7将骨植入物的第一骨植入物1和第二骨植入物2同时植入受损软组织4出,实现将软组织4固定在骨表面上。
定位套管7用于定位目标位置时,首先使用电钻,将一根克氏针,在需要修复软组织4的合适位置打骨髓道定位,然后取下电钻,将克氏针保留在定位点,然后将定位点的克氏针***定位套管7的第一套管701,旋转定位套管7,寻找第二个位置点,然后将另一个克氏针***第二套管702内,使用电钻打另一个骨髓道;
在植入骨植入物时,第一骨植入物1嵌设在第一凹槽6011内,第二骨植入物2嵌设在第二凹槽6021内,然后按压按压件604,将联结元件3嵌入第一手柄6031和第二手柄6032的结合缝隙处,然后松开按压件604,联结元件3固定在第一手柄6031和第二手柄6032的结合缝隙处,第一缝线102和第二缝线202游离在手柄603外,然后取出第一套管701和第二套管702内的克氏针,***器6的第一轴601和第二轴602分别***第一套管701和第二套管702内,使用器械敲击手柄603的近端,直到手柄603的远端接触到定位套管7的近端;
收线,轻微将***器6拔出一段距离后,使第一圆鞘101和第二圆鞘201形变成柔性结1’、2’,然后按压按压件604,释放联结元件3,取出***器6和定位套管7,最后均匀牵拉第一缝线102和第二缝线202的游离端,使联结元件3均匀移动,最终固定在软组织4表面,剪掉多余的第一缝线102和第二缝线202。最终将骨植入物植入骨5中后的状态如图2所示。
本实施例的骨植入物适用于,至少一个骨髓道是在具有软组织4的骨表面上,第一骨植入物1和第二骨植入物2植入后,联结元件3相当于锁扣,固定在骨表面,其中一处具有软组织4,即可将软组织4与骨固定。特别适用于软组织4从骨表面撕脱或撕裂的修复手术。
上面结合附图对本发明的实施方式作了详细说明,但是本发明并不限于
上述实施方式。即使对本发明做出各种变化,倘若这些变化属于本发明权利要求及其等同技术的范围之内,则仍落入在本发明的保护范围之中。
Claims (18)
- 一种用于软组织固定的骨植入物,其特征在于,包括第一骨植入物和第二骨植入物以及联结元件,所述第一骨植入物包括第一缝线和第一圆鞘,所述第一缝线穿过所述第一圆鞘;所述第二骨植入物包括第二缝线和第二圆鞘,所述第二缝线穿过所述第二圆鞘;所述第一缝线形成缝线环后穿过所述联结元件游离在所述联结元件外,所述第二缝线形成缝线环后穿过所述联结元件游离在所述联结元件外;所述第一骨植入物和第二骨植入物分别被配置目标对象后,所述第一圆鞘和第二圆鞘形变为柔性结,分别收紧第一缝线和第二缝线,联结元件固定在目标对象表面。
- 根据权利要求1所述的用于软组织固定的骨植入物,其特征在于,所述骨植入物为编织形成的编织线,所述联结元件为所述编织线上的圆管,所述圆管两端的通孔为第一孔和第二孔,所述圆管两侧的编织线为第一缝线和第二缝线。
- 根据权利要求2所述的用于软组织固定的骨植入物,其特征在于,所述第一缝线折弯穿入所述联结元件的第一孔,从所述第二孔穿出;所述第二缝线折弯穿入所述联结元件的第二孔,从所述第一孔穿出。
- 根据权利要求2所述的用于软组织固定的骨植入物,其特征在于,所述联结元件上还具有第三孔和/或第四孔,所述第一缝线折弯穿入所述联结元件的第一孔,从所述第三孔或第四孔穿出;所述第二缝线折弯穿入所述联结元件的第二孔,从所述第三孔或第四孔穿出。
- 根据权利要求2所述的用于软组织固定的骨植入物,其特征在于,所述编织线为超高分子量聚乙烯纤维或聚酯纤维原料编织而成。
- 根据权利要求1-5任意一项所述的用于软组织固定的骨植入物,其特征在于,所述第一圆鞘和/或第二圆鞘分别为编织形成的套管结构,所述第一 圆鞘套设在所述第一缝线上,所述第二圆鞘套设在所述第二缝线上。
- 根据权利要求6所述的用于软组织固定的骨植入物,其特征在于,所述套管结构的横截面为圆形或扁形状。
- 根据权利要求1-5任意一项所述的用于软组织固定的骨植入物,其特征在于,所述第一圆鞘和/或第二圆鞘均为片状编织结构,所述第一圆鞘上至少开设有第一穿线孔和第二穿线孔,所述第一缝线依次穿过所述第一穿线孔和第二穿线孔;所述第二圆鞘上至少开设有第三穿线孔和第四穿线孔,所述第二缝线依次穿过所述第三穿线孔和第四穿线孔。
- 一种***器,应用于权利要求1-8任一项所述的用于软组织固定的骨植入物,其特征在于,包括手柄和第一轴和第二轴,所述第一轴和第二轴固定于所述手柄,所述第一轴的远端具有第一凹槽,所述第二轴的远端具有第二凹槽,第一骨植入物中第一圆鞘抵靠在所述第一凹槽的底部,所述第二骨植入物中第二圆鞘抵靠在所述第二凹槽的底部。
- 根据权利要求9所述的***器,其特征在于,所述骨植入物的联结元件可拆卸地连接于所述手柄,第一缝线和第二缝线的游离端游离在所述***器外。
- 根据权利要求10所述的***器,其特征在于,所述手柄包括第一手柄和第二手柄,所述联结元件可拆卸地压制在所述第一手柄和第二手柄远端结合处。
- 根据权利要求10或11所述的***器,其特征在于,所述第一手柄上设置按压件,用于控制所述联结元件压制于所述缝隙处。
- 根据权利要求12所述的***器,其特征在于,所述第二手柄内设置弹性件,所述弹性件的一端固连所述第二手柄,另一端固连所述按压件,所述按压件沿所述***器的轴向延伸,形成延伸部,所述延伸部与所述手柄通过挤压作用压制所述联结元件。
- 根据权利要求9所述的***器,其特征在于,所述第一轴和第二轴的材质均为钛合金、不锈钢或镍钛合金。
- 一种定位套管,应用于权利要求1-8任一项所述的用于软组织固定的骨植入物和权利要求9-14任一项所述的***器,其特征在于,所述定位套管包括第一套管、第二套管和外壳,所述第一套管和第二套管固定于所述外壳内,所述定位套管用于在目标物上定位目标位置;所述***器的第一轴和第二轴分别***所述第一套管和第二套管,并穿出所述第一套管和第二套管。
- 根据权利要求15所述的定位套管,其特征在于,所述第一套管和第二套管的材质均为钛合金、不锈钢或镍钛合金。
- 一种软组织固定的植入***,其特征在于,包括权利要求1-8任一项所述的用于软组织固定的骨植入物、权利要求9-14任一项所述的***器和权利要求14或15所述的定位套管,所述定位套管用于在目标对象上定位目标位置,所述***器用于驱动所述骨植入物配置在所述目标对象内。
- 根据权利要求17所述的软组织固定的植入***,其特征在于,所述定位套管定位目标位置,第一骨植入物嵌设在第一凹槽内,第二骨植入物嵌设在第二凹槽内,第一轴和第二轴分别***第一套管和第二套管内,敲击所述***器,直到所述手柄的远端接触所述定位套管的近端,所述第一骨植入物和第二骨植入物分别被配置到目标对象内;抽离部分所述***器,所述第一圆鞘和第二圆鞘均形变收缩形成柔性结,完全抽离所述***器和定位套管,分别牵拉第一缝线和第二缝线的游离端,联结元件固定在目标对象表面。
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