WO2019128776A1 - 医用缝合装置及缝合系统 - Google Patents

医用缝合装置及缝合系统 Download PDF

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Publication number
WO2019128776A1
WO2019128776A1 PCT/CN2018/121735 CN2018121735W WO2019128776A1 WO 2019128776 A1 WO2019128776 A1 WO 2019128776A1 CN 2018121735 W CN2018121735 W CN 2018121735W WO 2019128776 A1 WO2019128776 A1 WO 2019128776A1
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WO
WIPO (PCT)
Prior art keywords
needle
proximal end
sheath
distal end
buckle
Prior art date
Application number
PCT/CN2018/121735
Other languages
English (en)
French (fr)
Inventor
周涵
陈文俊
Original Assignee
先健科技(深圳)有限公司
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Publication of WO2019128776A1 publication Critical patent/WO2019128776A1/zh

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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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • 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
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00628—T-shaped occluders
    • 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
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0403—Dowels
    • 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
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0417—T-fasteners
    • 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
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0464—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors for soft tissue

Definitions

  • the invention relates to the field of interventional medical technology, in particular to a medical suturing device and a suturing system.
  • patent foramen ovale is the most common congenital heart abnormality in adults. In the normal population, 20%-25% of the foramen ovale is not completely closed. Unclosed foramen ovale can cause thrombosis of deep veins or pelvic veins of the lower extremities, air emboli caused by diving or decompression sickness, and fat emboli formed after surgery or trauma enter the left heart system and cause corresponding clinical symptoms. . At the same time, patent foramen ovale is also closely related to decompression sickness, migraine and stroke.
  • patent foramen ovale mainly relied on surgery.
  • the success rate of surgical treatment was high, and the mortality rate was low.
  • the trauma was large, and complications such as atrial fibrillation, pericardial effusion, postoperative bleeding and wound infection may occur. It has rarely been adopted.
  • patent foramen ovale can be cured by interventional therapy.
  • Clinical practice in recent years has proven that this technique is a safe, effective and feasible way to permanently close an open foramen ovale.
  • the occluder generally comprises two mesh plates and a connecting piece connecting the two mesh plates.
  • the two mesh plates are respectively stuck in the left and right atrium and block the housing.
  • the outlet of the foramen ovale on both sides of the interval, the connecting member connects the left and right discs through the passage of the oval hole to complete the sealing on both sides.
  • Interventional treatment of the foramen ovale with an occluder can prevent the risk of surgery and the area of the wound, which can greatly reduce the risk of surgery and recovery.
  • the protruding portion in the left and right atrium is liable to cause a thrombus, and the foramen ovale is generally a sandwich structure, and a large deformation occurs when the occlusion device is used to clamp the interatrial septum. It will cause the left and right discs to be misaligned, and there is a drag force between the two discs, which will make the occluder's deformation amount and working load larger, so the overall structure will have certain fatigue risk under the heart pulsating motion.
  • the puncture assembly has only one needle, and the puncture tube needs to be puncture once before suturing, and then the puncture tube is adjusted and then puncture is performed, that is, not only the bending is required. Puncture the tube, but also push the puncture assembly twice to puncture, the operation is very inconvenient and takes a long time.
  • a medical suturing device comprising a puncture assembly, the puncture assembly comprising a first needle and a second needle, the tip of the first needle and the tip of the second needle are always facing the piercing assembly The distal extension.
  • the medical suturing device further includes a wire assembly including a suture, a first buckle, and a second buckle, one end of the suture being coupled to the first buckle, The other end is connected to the second buckle, the first buckle is connected to the first needle, the second buckle is connected to the second needle, and the suture is clamped to the first Between the needle and the second needle.
  • a wire assembly including a suture, a first buckle, and a second buckle, one end of the suture being coupled to the first buckle, The other end is connected to the second buckle, the first buckle is connected to the first needle, the second buckle is connected to the second needle, and the suture is clamped to the first Between the needle and the second needle.
  • the piercing assembly comprises a double-ended puncture needle and a thimble, the double-ended puncture needle comprising the first needle and the second needle, the first needle having a first cavity and two An end opening, the second needle has a second cavity open at both ends, a proximal end of the first needle being coupled to a proximal end of the second needle and maintaining a proximal end of the first needle and the first end a proximal end of the two needles is open, a side of the first needle opposite to the second needle is provided with a first opening, and a second needle is opposite to the first opening Opening, a distal end of the first opening extends to a distal end of the first needle, and a distal end of the second opening extends to a distal end of the second needle; the thimble a first ram and a second ram, the proximal end of the first ram being coupled to the proximal end of the second ram, the distal end of the
  • the piercing assembly further includes a fixing member and an outer tube
  • the fixing member has a cavity and the proximal end is provided with an opening, and the distal end of the outer tube and the proximal end of the fixing member Connecting, and an inner diameter of the outer tube is larger than a diameter of a proximal end opening of the fixing member, a proximal end of the double-ended puncture needle is connected to a distal end of the fixing member, and a proximal end of the thimble is received in the The cavity of the fixture.
  • the piercing assembly further includes a fixing block, the fixing block is received in the cavity of the fixing member, and the proximal end of the thimble is received in the cavity of the fixing member and fixed The remote connection of the block.
  • the medical suturing device further includes a first connector, the proximal end of the first needle being coupled to the proximal end of the second needle by the first connector.
  • the medical suturing device further includes a second connector, the proximal end of the first plunger and the proximal end of the second plunger being coupled by the second connector.
  • the first needle is connected to the second needle in a V-shape or a U-shape.
  • the first needle is parallel to the second needle, and the first plunger is parallel to the second plunger.
  • the first buckle is in the shape of a rod when being constricted in the first cavity, and is in a planar expansion after sliding out from the distal end of the first needle.
  • the two buckles are rod-shaped when being bundled in the second cavity, and are in a planar expansion shape after sliding out from the distal end of the second needle.
  • the piercing assembly includes a first jack and a second jack connected to the first jack, the first jack being the first needle, and the second jack a second needle; the first buckle is tubular, and the first buckle is sleeved on the first ram, the second buckle is tubular, and the second buckle Nested on the second ram.
  • the first delivery cable and the first sheath are further included, the medical suturing device of claim 1 further comprising a distal end of the first delivery cable connected to the piercing assembly
  • the piercing assembly is housed in the first sheath tube.
  • the medical suturing system further includes a towing assembly, a second delivery cable, and a second sheath, the tow assembly including a left and a third connector connected to each other, the third connector a proximal end coupled to the distal end of the second delivery cable, the tow assembly extending through the second sheath from a proximal end of the second sheath, and the second sheath is delivered from the delivery The proximal end of the first sheath extends through the first sheath.
  • the left disk is linear when the second sheath is closed, and the left disk is a disk-shaped body having a hollow when not being constricted in the second sheath.
  • the distal end of the piercing assembly can penetrate the left disk.
  • the third connector comprises a plurality of guide wires, a distal end of the guide wire is coupled to the left disk, and a proximal end of the guide wire is distal to the second delivery cable End connection.
  • the guide wires are arranged at intervals or by braiding to form the third connector.
  • the first sheath has a third cavity and a fourth cavity that are parallel to each other, the medical suturing device penetrating the first sheath from a proximal end of the first sheath,
  • the second sheath extends through the first sheath from a proximal end of the first sheath.
  • the medical suturing device not only does not need to adjust the puncture tube, but also needs to push the puncture component at one time, and can complete the two pinholes required for one suturing without repeatedly pushing the puncture component repeatedly, which is convenient to operate and saves a certain operation time. .
  • FIG. 1 is a schematic view showing the structure of a medical suturing system of Embodiment 1;
  • FIG. 2 is a schematic structural view of a suturing device in the medical suturing system of Embodiment 1;
  • Figure 3 is a cross-sectional structural view of the distal end of the suturing device of Figure 2;
  • Figure 4 is a schematic cross-sectional view showing the overall structure of the suturing device of Figure 2;
  • Figure 5 is a schematic view showing the structure of the towing assembly housed in the second sheath tube in the first embodiment
  • FIG. 6 is a schematic structural view of the towing assembly of the first embodiment after the left disk is released;
  • Figure 7 is a schematic view showing the structure of the body at the foramen ovale
  • Figure 8 is a schematic view showing the left disc in the left atrium after being released in the first embodiment
  • Figure 9 is a schematic view showing the suture device puncture the overlapping area of the atrial wall when the left disc drags the atrial wall in the first embodiment
  • Figure 10 is a schematic view of the dragging component of Figure 9;
  • Figure 11 is a schematic view of the suturing device of the first embodiment when the suture device is retained in the left atrium after suturing;
  • FIG. 12 is a schematic structural view of a double-ended puncture needle in the medical suturing system of Embodiment 1;
  • Figure 13 is a schematic structural view of a suturing device in the medical suturing system of Embodiment 2;
  • Figure 14 is a schematic cross-sectional view of Figure 13;
  • Figure 15 is a schematic view showing the structure of the double-headed puncture needle of Figure 13;
  • Figure 16 is a schematic view showing the structure of a wire assembly in the medical suturing system of the third embodiment.
  • the end of the medical device implanted in the human body or the animal body is generally referred to as the proximal end, and the end farther from the operator is referred to as the distal end, and This principle defines the proximal and distal ends of any component of a medical device.
  • Embodiment 1 provides a medical suturing system 10, see FIG. 1, including a medical suturing device 100, a first delivery cable 200, and a first sheath 300, further including a tow assembly 400, a second delivery cable 500, and a second Sheath 600.
  • the proximal end of the medical suturing device 100 is coupled to the distal end of the first delivery cable 200
  • the proximal end of the towing assembly 400 is coupled to the distal end of the second delivery cable 500.
  • the first sheath 300 has a third cavity that is parallel to each other.
  • the medical suturing device 100 penetrates the first sheath tube 300 from the proximal end of the first sheath tube 300
  • the towing assembly 400 penetrates the second sheath tube 600 from the proximal end of the second sheath tube 600, during delivery
  • the second sheath tube 600 extends through the first sheath tube 300 from the proximal end of the first sheath tube 300.
  • the medical suturing device 100 includes a wire assembly 110 and a piercing assembly 120.
  • the wire assembly 110 includes a suture 111, a first buckle 112 and a second buckle 113.
  • One end of the suture 111 is connected to the first buckle 112, and the other end is connected to the second buckle 113.
  • the first buckle 112 is tubular
  • the second buckle 113 is tubular
  • one end of the suture 111 is connected to the middle of the first buckle 112, and the other end is connected to the middle of the second buckle 113.
  • a hole is punched in the middle of each of the first buckle 112 and the second buckle 113, and one end of the suture 111 passes through the opening in the middle of the first buckle 112, and is knotted, so that one end of the suture 111 is first.
  • the buckle 112 is connected.
  • the other end of the suture 111 is knotted through the opening in the middle of the second buckle 113, thereby connecting the other end of the suture 111 to the second buckle 113.
  • the first buckle 112 and the second buckle 113 can be made of nickel-titanium alloy, titanium alloy, cobalt-chromium alloy, stainless steel 316L, polytetrafluoroethylene (PTFE), etc., or can be made of polylactic acid or magnesium.
  • the first buckle 112 and the second buckle 113 each have a length of 3 mm to 8 mm, and the shape may be a letter type, a Y shape or an X shape, wherein the end
  • the separate parts can be cut by the pipe or directly processed.
  • the diameter of the suture 111 is 0.1 mm to 0.5 mm, and the length thereof may be determined according to the distance to be sutured, and generally 2 mm to 8 mm may be selected.
  • the suture 111 can be made of the same material as the first buckle 112 or the second buckle 113, or a PA (nylon) thread, a PET (polyethylene terephthalate) thread, or a PE (polyethylene). ) Made of wire or ultra high molecular weight polyethylene wire.
  • the piercing assembly 120 includes a double-ended puncture needle 121 and a thimble 122, and further includes a fixed block 123, a fixture 124, and an outer tube 125.
  • the double-ended puncture needle 121 includes a first needle 1211 and a second needle 1212. The tip of the first needle 1211 and the tip of the second needle 1212 always extend toward the distal end of the puncture assembly 120.
  • the first needle 1211 has a first cavity 1213. And the two ends are open, the second needle 1212 has a second cavity 1214 and is open at both ends.
  • the proximal end of the first needle 1211 is connected to the proximal end of the second needle 1212 and maintains the proximal end of the first needle 1211 and the second needle 1212.
  • the first end of the first needle 1211 opposite to the second needle 1212 is provided with a first opening 1215
  • the second needle 1212 is provided with a second opening opposite to the first opening 1215 (not shown)
  • the distal end of the first opening 1215 extends to the distal end of the first needle 1211 and the distal end of the second opening extends to the distal end of the second needle 1212.
  • the ejector pin 122 includes a first ejector 1221 and a second ejector 1222.
  • the proximal end of the first ram 1221 is coupled to the proximal end of the second ram 1222.
  • the outer diameter of the first ejector 1221 is slightly smaller than the inner diameter of the first lance 1211.
  • the outer diameter of the first jack 1221 is larger than the outer diameter of the first buckle 112, the outer diameter of the second jack 1222 is slightly smaller than the inner diameter of the second needle 1212, and the outer diameter of the second jack 1222 is larger than the second card.
  • the outer diameter of the buckle 113 extends from the proximal end of the first needle 1211 into the first cavity 1213, and the distal end of the second plunger 1222 extends from the proximal end of the second needle 1212. Within the two chambers 1214.
  • the first buckle 112 is received in the first cavity 1213
  • the second buckle 113 is received in the second cavity 1214
  • the outer diameter of the first plunger 1221 is larger than the first An outer diameter of the buckle 112
  • the outer diameter of the second jack 1222 is larger than the outer diameter of the second buckle 113
  • the suture 111 is located between the first opening 1215 and the second opening, that is, the suture 111 is interposed. Between the first needle 1211 and the second needle 1212.
  • the first ejector pin 1221 pushes the first buckle 112 to move distally within the first cavity 1213, and the second ram 1222 pushes the second buckle 113 to the second cavity.
  • the inside of the 1214 moves toward the distal end, and at the same time, one end of the suture 111 moves distally along the first opening 1215, and the other end moves distally along the second opening.
  • the double-headed needle 121 can be made by cutting and heat setting a metal tube such as a nickel-titanium alloy, a titanium alloy, a cobalt-chromium alloy or a stainless steel 316L, or a polymer material such as polytetrafluoroethylene, which can be injection molded or processed. to make. Since the nickel-titanium alloy material has superelasticity and shape memory, the double-headed puncture needle 121 is preferably made of a nickel-titanium alloy tube, and the double-ended puncture needle 121 made of a nickel-titanium alloy tube is in a state of being confined in the first sheath tube 300. The compressed state, when extended from the first sheath tube 300, can rebound to its original shape.
  • a metal tube such as a nickel-titanium alloy, a titanium alloy, a cobalt-chromium alloy or a stainless steel 316L, or a polymer material such as polytetrafluoroethylene, which can be injection molded or
  • the maximum outer diameter of the double-ended puncture needle 121 is less than or equal to 1.8 mm, and the minimum inner diameter is greater than or equal to 0.6 mm.
  • the distance between the distal end of the first needle 1211 and the distal end of the second needle 1212 is 1.1-1.3 times the length of the suture 111.
  • the width of the first opening 1215 is slightly larger than the diameter of the suture 111, and the width of the second opening is also slightly larger than the diameter of the suture 111.
  • the thimble 122 can be made of the same material as the double-ended puncture needle 121.
  • the fixing member 124 has a cavity 1241 and a proximal end 1242.
  • the distal end of the outer tube 125 is connected to the proximal end of the fixing member 124 by gluing, screwing, welding, etc., and the outer diameter of the outer tube 125 is equal to Or slightly smaller than the diameter of the proximal opening 1242 of the fixing member 124, the proximal end of the double-ended puncture needle 121 is connected to the distal end of the fixing member 124, and the fixing block 123 is received in the cavity 1241 of the fixing member 124, and the proximal end of the thimble 122 It is received in the cavity 1241 of the fixing member 124 and connected to the distal end of the fixing block 123.
  • the distal end of the first delivery cable 200 extends from the proximal opening 1242 of the fixing member 124 into the cavity 1241 of the fixing member 124 and is connected to the proximal end of the fixing block 123.
  • the connection manner can be screw connection, gluing, and use. Tight fit for dimensional tolerances.
  • the outer tube 125 can be a metal tube or a polymer tube.
  • the fixing member 124 can be processed by using an implantable material such as titanium alloy, cobalt chromium alloy, stainless steel 316L or polytetrafluoroethylene.
  • the proximal end of the double-ended puncture needle 121 and the fixing member 124 can be fixedly connected by means of gluing or tight tolerance.
  • the distal end of the outer tube 125 and the proximal end of the fixing member 124 may be connected by threading, gluing or tight fitting.
  • the inner diameter of the outer tube 125 is slightly larger than the outer diameter of the first delivery cable 200.
  • the outer tube 125 may be a braided steel cable, or may be made of other metal materials such as a soft guide wire such as a titanium alloy, a cobalt chromium alloy, or a stainless steel 316L or a catheter.
  • the first transfer cable 200 and the second transfer cable 500 may each be a braided steel cable, or may be made of other metal materials such as a soft guide wire such as a titanium alloy, a cobalt chromium alloy, or a stainless steel 316L or a conduit.
  • the shape of the fixing member 124 is not limited as long as it can be accommodated in the cavity of the first sheath tube 300.
  • the shape of the fixing block 123 is not limited as long as it can be accommodated inside the fixing member 124 and slide in the axial direction of the fixing member 124.
  • the proximal end of the thimble 122 can be coupled to the distal end of the fixed block 123 in a variety of manners. In other embodiments, the proximal end of the first jack 1221 may not be connected to the proximal end of the second jack 1222. The proximal end of the first jack 1221 and the proximal end of the second jack 1222 may be respectively inserted into the fixing block 123.
  • the distal end is connected, and the connection method can be screw connection, gluing, tight fit with dimensional tolerances, and the like.
  • the piercing assembly 120 may not include the fixed block 123.
  • the distal end of the first delivery cable 200 extends from the proximal opening 1242 of the fixture 124 into the cavity 1241 of the fixture 124 and with the thimble 122.
  • the proximal connection is as long as the proximal end of the thimble 122 can be coupled to the distal end of the first delivery cable 200 and moved distally under the push of the first delivery cable 200.
  • the proximal end of the first needle 1211 and the proximal end of the second needle 1212 are connected by a first connecting member 1217, and the proximal end of the first plunger 1221 and the proximal end of the second plunger 1222 are connected by a fixing block 123.
  • the proximal end of the first needle 1211 can be directly coupled to the proximal end of the second needle 1212.
  • the proximal end of the first jack 1221 can be directly connected to the proximal end of the second jack 1222 or can be connected through the second connector.
  • the first needle 1211 and the second needle 1212 are V-shaped, and the first plunger 1221 and the second plunger 1222 are V-shaped.
  • the first needle 1211 is parallel to the second needle 1212 and the proximal end of the first needle 1211 and the proximal end of the second needle 1212 are connected by a first connecting member 1217.
  • the first needle 1211 and the second needle 1212 can be
  • the first ejector pin 1221 is parallel to the second ejector pin 1222 and the proximal end of the first ejector pin 1221 and the proximal end of the second ram 1222 are connected by a second connecting member.
  • the first ejector pin 1221 It can be seen as a U-shaped connection with the second jack 1222.
  • the towing assembly 400 is used to drag the tissue to be sutured, so that the tissue of the portion to be suture is not excessively deformed when the puncture assembly 120 is punctured, thereby affecting the suturing effect.
  • the towing assembly 400 includes a left disk 410 and a third connector 420 that are connected to each other.
  • the proximal end of the third connector 420 is coupled to the distal end of the second conveyor cable 500.
  • the towing assembly 400 The second sheath tube 600 is inserted from the proximal end of the second sheath tube 600.
  • the left disk 410 has elasticity and shape memory.
  • the left disk 410 is linear when it is converged in the second sheath 600 (please refer to FIG.
  • the left disk 410 is disk-shaped when it is not constricted in the second sheath 600.
  • the left disc 410 is a hollow disc having a hollow when it is not constricted within the second sheath 600, and the distal end of the double-ended puncture needle 121 can penetrate the left disc 410.
  • the overall shape of the left disc 410 may be a circle, a square, a diamond, or the like, and the shape is not limited.
  • the hollow shape on the left disc 410 is not limited as long as the distal end of the double-ended puncture needle 121 can penetrate the left disc 410.
  • the third connector 420 includes a plurality of guide wires 421, the distal end of which is coupled to the left disk 410, and the proximal end of the guide wire 421 is coupled to the distal end of the second delivery cable 500.
  • a plurality of guide wires 421 are spaced apart to form a third connecting member 420.
  • a plurality of guide wires 421 constitute a third connector 420 by weaving.
  • the left disk 410 can be heat-set by cutting a nickel-titanium alloy tube. Both ends of the third connecting member 420 may be connected to the distal ends of the left disc 410 and the second transporting steel cable 500 by welding, braiding, gluing or the like.
  • the guide wire 421 is a flexible metal wire, such as nickel titanium wire, stainless steel wire, PET wire, PA wire, PTFE wire, PE wire or ultra high molecular weight polyethylene wire, etc., so that it has good flexibility and can be bent at will, It has a certain strength and can withstand the sheath pull force of 40N or more.
  • the first sheath tube 300 having two cavities is used to separate the medical suturing device 100 and the towing assembly 400, thereby avoiding the inconvenience and risk of mutual interference between the two in the first sheath tube 300.
  • the first sheath tube 300 can also be a single lumen tube.
  • the medical suturing system 10 may not include the tow assembly 400 and the second delivery cable 500. After the medical suturing device 100 is coupled to the first delivery cable 200, it reaches the in vivo target area under the delivery of the first sheath 300. The target tissue can be sutured.
  • the treatment of patent foramen ovale is not limited, but the medical suturing device 100 is not limited to the treatment of patent foramen ovale.
  • the box shows a schematic diagram of the internal structure of the patent foramen ovale.
  • the two atrium walls of the patent foramen ovale have an overlapping area, which can be sutured in the overlapping area by the medical suturing device 100.
  • the two atrial walls are sutured together to achieve the purpose of blocking the blood shunt at the foramen ovale.
  • the stitching process includes the following steps:
  • a second sheath 600 (not shown) having a conical sheath core extends from the proximal end of the first sheath 300 into the fourth lumen 320 of the first sheath 300 and pushes it to the first The distal end of the sheath tube 300, and the distal end of the sheath core extends from the distal end of the second sheath tube 600;
  • the distal end of the first sheath tube 300 is delivered to the right atrium by means of a device such as a bronchoscope; the sheath core and the second sheath tube 600 are pushed out from the distal end of the first sheath tube 300 to make the sheath
  • the core and the second sheath tube 600 are inserted into the foramen ovale to the left atrium; the sheath core is withdrawn;
  • the first conveying cable 200 is pushed distally, and the distal end of the first conveying cable 200 drives the fixing block 123 and the thimble 122 to move toward the distal end synchronously.
  • the distal end of the first jack 1221 is at the first end.
  • the first buckle 112 is pushed into the cavity 1213 toward the end of the first needle 1211, and the distal end of the second plunger 1222 pushes the second buckle 113 in the second cavity 1214 toward the end of the second needle 1212.
  • the suture 111 moves distally between the first buckle 112 and the second buckle 113 as the first buckle 112 and the second buckle 113 move; when the distal end of the first buckle 112 is After the first cavity 1213 is pushed out and the distal end of the second buckle 113 is pushed out of the second cavity 1214, the outer tube 125 is pushed toward the proximal end and the double-ended puncture needle 121 is withdrawn.
  • the first buckle 112 and the second buckle 112 The buckle 113 is left in the left atrium and hung on the wall of the atrium, and most of the suture 111 remains in the right atrium, thereby suturing the two atrial walls at the foramen ovale;
  • the outer tube 125 is withdrawn to cause the puncture assembly 120 to be confined within the first sheath tube 300; the first sheath tube 300 and the puncture assembly 120 and the first delivery cable 200 that are confined within the first sheath tube 300 are withdrawn Out of the body, thus completing a suture.
  • the same operation can be used to stitch another wire assembly 110 to the overlap region to enhance the stitch tightness between the two sheets.
  • the number of repeated operations may be determined according to actual needs, and the number of required line components 110 is also determined according to the number of repeated operations.
  • the length of the suture 111 is d, and the distance between the distal end of the first needle 1211 and the distal end of the second needle 1212 is D, since the suture 111 is located at the first needle 1211 and The two needles 1212 are linear and therefore d is smaller than D, so that after suturing, the suture 111 is tightened between the two puncture points to ensure the suturing effect. It will be appreciated that by adjusting the angle between the first needle 1211 and the second needle 1212, and the initial mounting position of the suture 111 between the first needle 1211 and the second needle 1212, the suture 111 can be adjusted in two punctures. The degree of tightness between the points.
  • the medical suturing device 100 of the first embodiment can perform the suturing operation in the body simply and quickly by the cooperation of the puncture assembly 120 and the wire assembly 110 by using the interventional suturing means, thereby avoiding, for example, the thoracotomy when treating the patent foramen ovale.
  • the surgical risk and wound area are greatly reduced, which is conducive to postoperative recovery.
  • the suture 111 does not need to perform a knotting operation in the body, which reduces the difficulty of surgery, saves the operation time, and reduces the pain of the patient.
  • the wire assembly 110 is retained in the body. Due to the small volume of the wire assembly 110, the risk of complications of the implant in the body can be greatly reduced, and the surrounding tissue is not damaged. And because the tension of the suture 111 is small, the risk of fatigue failure is also low.
  • the first buckle 712 is tubular
  • the second buckle 713 is tubular
  • the suture 711 One end is connected to the middle of the first buckle 712, and the other end is connected to the middle of the second buckle 713
  • the outer diameter of the first jack 7221 is smaller than the inner diameter of the first buckle 712
  • the outer diameter of the second jack 7222 The inner diameter of the second buckle 713 is smaller than the inner diameter of the second buckle 713, so that the distal end of the first plunger 7221 can extend into the cavity of the first buckle 712, and the distal end of the second plunger 7222 can extend into the cavity of the second buckle 713.
  • the distal end of the first jack 7221 is in the shape of a needle
  • the distal end of the second plunger 7222 is in the shape of a needle. That is, the distal end of the first plunger 7221 functions the same as the first needle 1211 in the first embodiment, and the distal end of the second plunger 7222 functions as the second needle 1212 in the first embodiment.
  • the puncture function is the same. It can also be understood that the first plunger 7221 is the solid first needle 7211 in the present embodiment, and the second plunger 7222 is the solid second needle 7212 in the embodiment.
  • first opening 7215 is not provided with the first opening 1215
  • second opening 7212 is not provided with the second opening
  • the outer diameter of the first buckle 712 is greater than or equal to the inner diameter of the first needle 7211.
  • the outer diameter of the second buckle 713 is greater than or equal to the inner diameter of the second needle 7212.
  • the proximal end of the first buckle 712 is closer to the distal end of the medical suturing device than the distal end of the first needle 7211, and the proximal end of the second buckle 713 is closer.
  • the distal end of the second needle 7212 is adjacent the distal end of the medical suturing device.
  • the distal end of the first needle 7211 may remain in the shape of a needle in Embodiment 1, or may not be in the shape of a needle, and the distal end of the second needle 7212 may remain as in Embodiment 1.
  • the needle shape is also not a needle shape. It can also be understood that in other embodiments, the first needle 7211 and the second needle 7212 may also be omitted.
  • the principle of suturing is: conveying the distal end of the medical suturing device to the foramen ovale in the right atrium through the first sheath tube 300; and withdrawing the first sheath tube 300 to make the medical treatment
  • the distal end of the suturing device extends from the first sheath tube 300; the first delivery cable 200 is pushed distally so that the needle end of the first plunger 7221 and the needle end of the second plunger 7222 are punctured until The first buckle 712 and the second buckle 713 completely enter the left atrium; the position of the fixing fixture relative to the foramen ovale is unchanged, and the first delivery cable 200 is withdrawn to move the fixing block 723 toward the proximal end to the fixing member.
  • the first buckle 712 and the second buckle 713 are naturally detached into the left atrium, thereby completing the suturing operation, and the suturing effect is the same as that of the embodiment 1.
  • the length of the suture 711 is d, and the distance between the distal end of the first plunger 7221 and the distal end of the second plunger 7222 is D, since the suture 711 is located at the first plunger.
  • the 7221 and the second ejector rod 7222 are linear and so d is smaller than D, so that after suturing, the suture 711 is tightened between the two puncture points to ensure the suturing effect.
  • the suture 711 can be adjusted by adjusting the angle between the first ram 7221 and the second ram 7222 and the initial mounting position of the suture 711 between the first ram 7221 and the second ram 7222. The degree of tightness between the two puncture points.
  • Embodiment 3 and Embodiment 1 are not described herein again, and the difference mainly lies in that the first buckle 812 is rod-shaped when being constricted in the first cavity, and slides out from the distal end of the first needle.
  • the rearwardly flared shape see FIG. 16
  • the second buckle 813 is rod-shaped when it is converged in the second cavity, and is deployed in a plane after sliding out from the distal end of the second needle (see the figure). 16).
  • the first buckle 812 and the second buckle 813 are not limited in shape after deployment, and are used for fixing both ends of the suture at the end of the puncture point opposite to the main portion of the suture, as long as it is not easy to puncture after suturing One end of the point can be moved to the other end.
  • the piercing assembly used in conjunction with the wire assembly of Embodiment 3 can also be the piercing assembly of Embodiment 2.

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Abstract

一种医用缝合装置（100）和医用缝合系统（10），该医用缝合装置（100）包括穿刺组件（120），该穿刺组件（120）包括第一针头（1211）及第二针头（1212），该第一针头（1211）的针尖及该第二针头（1212）的针尖均始终朝该穿刺组件（120）的远端延伸。该医用缝合装置（100）和医用缝合系统（10）不仅无须调弯穿刺管，而且仅需一次推送穿刺组件（120），无需多次反复推送穿刺组件（120），即可完成一次缝合所需要的两个针孔，操作方便且节省操作时间。

Description

医用缝合装置及缝合系统 技术领域
本发明涉及介入医疗技术领域，尤其涉及一种医用缝合装置及缝合系统。
背景技术
卵圆孔未闭是目前成人中最为常见的一种先天心脏异常，在正常人群中有20％-25％的卵圆孔不完全闭合。不闭合的卵圆孔会导致下肢深静脉或盆腔静脉的血栓、潜水病或减压病所致的空气栓子，以及手术或外伤后形成的脂肪栓子进入左心系统而引起相应的临床症状。同时，卵圆孔未闭与减压病、偏头痛以及脑卒中也有着密切的联系。
以往治疗卵圆孔未闭主要依靠外科手术，手术治疗的成功率高，病死率低，但创伤大，可能会出现心房颤动、心包积液、术后出血和伤口感染等并发症，因此，近年来已很少采用。随着心导管技术的发展，卵圆孔未闭可经介入治疗进行根治。近年来的临床实践证明，这一技术能够永久性地关闭开放的卵圆孔，是安全、有效且可行的。
介入治疗大多是植入一种封堵器，封堵器一般包括两个网状盘以及连接这两个网状盘的连接件，两个网状盘分别卡在左右两个心房并堵住房间隔两侧的卵圆孔通路出口，连接件通过卵圆孔的通道将左右盘连接在一起完成两侧的封堵。卵圆孔用封堵器进行介入治疗，虽然可以避免开胸及开心手术，能够极大幅度减少手术风险和创口面积，有利于术后恢复。但是，由于封堵器的体积较大，在左右心房具有突出的部分容易造成血栓，且卵圆孔一般是一种夹层结构，在使用封堵器夹紧房间隔的时候会产生较大形变，会导致左 右盘发生错位，并且在两盘之间有拖拽力，会使得封堵器的变形量和工作负荷较大，故而整体结构在心脏脉动的运动下会有一定的疲劳风险。
而现有的采用穿刺针进行缝合的方式中，穿刺组件只有一个针头，且在缝合时需要借助穿刺管先进行一次穿刺，然后调弯穿刺管再进行一次穿刺，也就是说，不仅需要调弯穿刺管，而且还要推送两次穿刺组件进行穿刺，操作十分不便且需要的时间较长。
发明内容
基于此，有必要针对现有的采用穿刺针进行缝合的方式中存在的操作不便且操作时间较长的问题，提供一种医用缝合装置及缝合系统。
一种医用缝合装置，所述医用缝合装置包括穿刺组件，所述穿刺组件包括第一针头及第二针头，所述第一针头的针尖及所述第二针头的针尖均始终朝所述穿刺组件的远端延伸。
在其中一个实施例中，所述医用缝合装置还包括线组件，所述线组件包括缝合线、第一卡扣和第二卡扣，所述缝合线的一端与所述第一卡扣连接，另一端与所述第二卡扣连接，所述第一卡扣与所述第一针头相连，所述第二卡扣与所述第二针头相连，所述缝合线夹设于所述第一针头与所述第二针头之间。
在其中一个实施例中，所述穿刺组件包括双头穿刺针和顶针，所述双头穿刺针包括所述第一针头和所述第二针头，所述第一针头具有第一腔体且两端开口，所述第二针头具有第二腔体且两端开口，所述第一针头的近端与所述第二针头的近端连接且保持所述第一针头的近端和所述第二针头的近端均开口，所述第一针头的与所述第二针头相对的一侧设有第一开孔，所述第二针头上与所述第一开孔相对地设有第二开孔，所述第一开孔的远端延伸至所述第一针头的远端端部，所述第二开孔的远端延伸至所述第二针头的远端端部；所述顶针包括第一顶杆和第二顶杆，所述第一顶杆的近端与所述第二顶杆的近端连接，所述第一顶杆的远端从所述第一针头的近端伸入所述第一腔体内，所述第二顶杆 的远端从所述第二针头的近端伸入所述第二腔体内；所述第一卡扣收容于所述第一腔体内，所述第二卡扣收容于所述第二腔体内，且所述缝合线位于所述第一开孔和所述第二开孔之间。
在其中一个实施例中，所述穿刺组件还包括固定件和外管，所述固定件具有一腔体且近端设有一开孔，所述外管的远端与所述固定件的近端连接，且所述外管的内径大于所述固定件近端开孔的直径，所述双头穿刺针的近端与所述固定件的远端连接，所述顶针的近端收容于所述固定件的腔体内。
在其中一个实施例中，所述穿刺组件还包括固定块，所述固定块收容于所述固定件的腔体内，所述顶针的近端收容于所述固定件的腔体内且与所述固定块的远端连接。
在其中一个实施例中，所述医用缝合装置还包括第一连接件，所述第一针头的近端与所述第二针头的近端通过所述第一连接件连接。
在其中一个实施例中，所述医用缝合装置还包括第二连接件，所述第一顶杆的近端与所述第二顶杆的近端通过所述第二连接件连接。
在其中一个实施例中，所述第一针头与所述第二针头呈V字型或U字型连接。
在其中一个实施例中，所述第一针头与所述第二针头平行，所述第一顶杆与所述第二顶杆平行。
在其中一个实施例中，所述第一卡扣在被收束在所述第一腔体内时为杆状，在从所述第一针头的远端滑出后呈平面展开状，所述第二卡扣在被收束在所述第二腔体内时为杆状，在从所述第二针头的远端滑出后呈平面展开状。
在其中一个实施例中，所述穿刺组件包括第一顶杆及与所述第一顶杆相连的第二顶杆，所述第一顶杆为所述第一针头，所述第二顶杆为所述第二针头；所述第一卡扣为管状，且所述第一卡扣套设于所述第一顶杆上，所述第二卡扣为管状，且所述第二卡扣套设于所述第二顶杆上。
在其中一个实施例中，包括第一输送钢缆和第一鞘管，还包括上述权利要求1所述的医用缝合装置，所述第一输送钢缆的远端与所述穿刺组件相连，所述穿刺组件收容于所述第一鞘管。
在其中一个实施例中，所述医用缝合系统还包括拖曳组件、第二输送钢缆和第二鞘管，所述拖曳组件包括相互连接的左盘和第三连接件，所述第三连接件的近端与所述第二输送钢缆的远端连接，所述拖曳组件从所述第二鞘管的近端贯穿所述第二鞘管，且在输送时所述第二鞘管从所述第一鞘管的近端贯穿所述第一鞘管。
在其中一个实施例中，所述左盘收束在所述第二鞘管内时呈直线状，所述左盘未收束在所述第二鞘管内时为具有镂空的盘状体，且所述穿刺组件的远端可穿透所述左盘。
在其中一个实施例中，所述第三连接件包括若干根导丝，所述导丝的远端与所述左盘连接，所述导丝的近端与所述第二输送钢缆的远端连接。
在其中一个实施例中，所述导丝间隔排列或通过编织构成所述第三连接件。
在其中一个实施例中，所述第一鞘管具有相互平行的第三腔体和第四腔体，所述医用缝合装置从所述第一鞘管的近端贯穿所述第一鞘管，所述第二鞘管从所述第一鞘管的近端贯穿所述第一鞘管。
上述医用缝合装置，不仅无须调弯穿刺管，而且仅需一次推送穿刺组件，无需多次反复推送穿刺组件，即可完成一次缝合所需要的两个针孔，操作方便，节省了一定的操作时间。
附图说明
图1为实施例1的医用缝合系统的组成结构示意图；
图2为实施例1的医用缝合系统中缝合装置的结构示意图；
图3为图2中缝合装置的远端的剖面结构示意图；
图4为图2中缝合装置的整体剖面结构示意图；
图5为实施例1中拖曳组件收容于第二鞘管内的结构示意图；
图6为实施例1中拖曳组件在左盘被释放后的结构示意图；
图7为体内卵圆孔处的组织结构示意图；
图8为实施例1中左盘在左心房内被释放后的示意图；
图9为实施例1中当左盘拖曳住心房壁时缝合装置穿刺心房壁重合区域的 示意图；
图10为图9中撤回拖曳组件后的示意图；
图11为实施例1中缝合装置在缝合后卡扣留在左心房时的示意图；
图12为实施例1的医用缝合系统中双头穿刺针的结构示意图；
图13为实施例2的医用缝合系统中缝合装置的结构示意图；
图14为图13的剖面结构示意图；
图15为图13中双头穿刺针的结构示意图；
图16为实施例3的医用缝合系统中线组件的结构示意图。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本发明进行进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本发明，并不用于限定本发明。
需要说明的是，在介入医疗器械领域，一般将植入人体或动物体内的医疗器械的距离操作者较近的一端称为近端，将距离操作者较远的一端称为远端，并依据此原理定义医疗器械的任一部件的近端和远端。
以下将结合具体实施例进一步详细说明本发明的技术方案。
实施例1
实施例1提出一种医用缝合系统10，请参阅图1，包括医用缝合装置100、第一输送钢缆200和第一鞘管300，还包括拖曳组件400、第二输送钢缆500和第二鞘管600。医用缝合装置100的近端与第一输送钢缆200的远端连接，拖曳组件400的近端与第二输送钢缆500的远端连接，第一鞘管300具有相互平行的第三腔体310和第四腔体320，医用缝合装置100从第一鞘管300的近端贯穿第一鞘管300，拖曳组件400从第二鞘管600的近端贯穿第二鞘管600，在输送时第二鞘管600从第一鞘管300的近端贯穿第一鞘管300。
请一并参阅图2-图4，医用缝合装置100包括线组件110和穿刺组件120。线组件110包括缝合线111、第一卡扣112和第二卡扣113，缝合线111的一端与第一卡扣112连接，另一端与第二卡扣113连接。本实施例中，第一卡扣112 为管状，第二卡扣113为管状，缝合线111的一端与第一卡扣112的中部连接，另一端与第二卡扣113的中部连接，连接方式优选为在第一卡扣112和第二卡扣113各自的中部打孔，缝合线111的一端穿过第一卡扣112中部的开孔后打结，从而将缝合线111的一端与第一卡扣112连接，同样地，缝合线111的另一端穿过第二卡扣113中部的开孔后打结，从而将缝合线111的另一端与第二卡扣113连接。第一卡扣112和第二卡扣113均可以由镍钛合金、钛合金、钴铬合金、不锈钢316L、聚四氟乙烯(PTFE)等管材经切割后制成，也可以采用聚乳酸或者镁、铁及其合金等可吸收材料制成，第一卡扣112和第二卡扣113各自的长度为3mm-8mm，形状均可以为一字型、Y字型或X字型，其中，末端分开的部位可由管材切开或者直接加工而成。缝合线111的直径为0.1mm-0.5mm，其长度可根据需要缝合的距离而定，一般可选择2mm-8mm。缝合线111可选用与第一卡扣112或第二卡扣113相同的材料制成，也可以选用PA(尼龙)线、PET(聚对苯二甲酸乙二醇酯)线、PE(聚乙烯)线或者超高分子量聚乙烯线等制成。
穿刺组件120包括双头穿刺针121和顶针122，还包括固定块123、固定件124和外管125。双头穿刺针121包括第一针头1211和第二针头1212，第一针头1211的针尖及第二针头1212的针尖均始终朝穿刺组件120的远端延伸，第一针头1211具有第一腔体1213且两端开口，第二针头1212具有第二腔体1214且两端开口，第一针头1211的近端与第二针头1212的近端连接且保持第一针头1211的近端和第二针头1212的近端均开口，第一针头1211的与第二针头1212相对的一侧设有第一开孔1215，第二针头1212上与第一开孔1215相对地设有第二开孔(图未示)，第一开孔1215的远端延伸至第一针头1211的远端端部，第二开孔的远端延伸至第二针头1212的远端端部。顶针122包括第一顶杆1221和第二顶杆1222，第一顶杆1221的近端与第二顶杆1222的近端连接，第一顶杆1221的外径略小于第一针头1211的内径，且第一顶杆1221的外径大于第一卡扣112的外径，第二顶杆1222的外径略小于第二针头1212的内径，且第二顶杆1222的外径大于第二卡扣113的外径，第一顶杆1221的远端从第一针头1211的近端伸入第一腔体1213内，第二顶杆1222的远端从第二针头1212的近 端伸入第二腔体1214内。
在进行缝合时，请再次参阅图3，第一卡扣112收容于第一腔体1213内，第二卡扣113收容于第二腔体1214内，且第一顶杆1221的外径大于第一卡扣112的外径，第二顶杆1222的外径大于第二卡扣113的外径，缝合线111位于第一开孔1215和第二开孔之间，也即缝合线111夹设于第一针头1211与第二针头1212之间。当顶针122朝远端移动时，第一顶杆1221推着第一卡扣112在第一腔体1213内朝远端移动，第二顶杆1222推着第二卡扣113在第二腔体1214内朝远端移动，同时，缝合线111的一端沿着第一开孔1215朝远端移动，另一端沿着第二开孔朝远端移动。
双头穿刺针121可以由镍钛合金、钛合金、钴铬合金、不锈钢316L等金属管经切割和热定型制成，也可以采用高分子材料，例如聚四氟乙烯，经注塑或者加工成型制成。由于镍钛合金材料具有超弹性和形状记忆性，双头穿刺针121优选采用镍钛合金管制成，由镍钛合金管制成的双头穿刺针121在收束在第一鞘管300内时处于压缩状态，当从第一鞘管300内伸出后可以回弹至原有形状。双头穿刺针121的最大外径小于或等于1.8mm，最小内径大于或等于0.6mm。第一针头1211的远端端部与第二针头1212的远端端部之间的距离，是缝合线111的长度的1.1-1.3倍。第一开孔1215的宽度略大于缝合线111的直径，第二开孔的宽度也略大于缝合线111的直径。顶针122可采用与双头穿刺针121相同的材料制成。
固定件124具有一腔体1241且近端设有一开孔1242，外管125的远端与固定件124的近端通过胶粘、螺纹连接、焊接等方式连接，且外管125的外径等于或者略小于固定件124近端开孔1242的直径，双头穿刺针121的近端与固定件124的远端连接，固定块123收容于固定件124的腔体1241内，顶针122的近端收容于固定件124的腔体1241内且与固定块123的远端连接。第一输送钢缆200的远端从固定件124的近端开孔1242伸入固定件124的腔体1241内并与固定块123的近端连接，连接方式可以为螺纹连接、胶粘、用尺寸公差进行紧配合等。外管125可以为金属管或高分子管。固定件124可采用钛合金、钴铬合金、不锈钢316L、聚四氟乙烯等可植入材料加工而成。双头穿刺针121的 近端与固定件124可以采用胶粘或紧配合公差等方式进行固定连接。外管125的远端与固定件124的近端可采用螺纹、胶粘或者紧配合锁死等方式进行连接。外管125的内径略大于第一输送钢缆200的外径。外管125可以为编织钢缆，也可以采用其他金属材料，例如钛合金、钴铬合金、不锈钢316L等柔软导丝或者导管制成。第一输送钢缆200和第二输送钢缆500均可以为编织钢缆，也可以采用其他金属材料，例如钛合金、钴铬合金、不锈钢316L等柔软导丝或者导管制成。
固定件124的形状不限，只要能够收容于第一鞘管300的腔体内即可。固定块123的形状也不限，只要能够收容于固定件124的内部并沿固定件124的轴向滑动即可。顶针122的近端可采用多种方式与固定块123的远端连接。在其他实施例中，第一顶杆1221的近端也可不与第二顶杆1222的近端连接，第一顶杆1221的近端和第二顶杆1222的近端可分别插入固定块123的远端进行连接，连接方式可以为螺纹连接、胶粘、用尺寸公差进行紧配合等。在其他实施例中，穿刺组件120可以不包括固定块123，第一输送钢缆200的远端从固定件124的近端开孔1242伸入固定件124的腔体1241内并与顶针122的近端连接，只要顶针122的近端能够与第一输送钢缆200的远端连接并在第一输送钢缆200的推送下朝远端移动即可。
第一针头1211的近端与第二针头1212的近端通过第一连接件1217连接，第一顶杆1221的近端与第二顶杆1222的近端通过固定块123连接。在其他实施例中，第一针头1211的近端与第二针头1212的近端可直接连接。在其他实施例中，第一顶杆1221的近端与第二顶杆1222的近端可直接连接，也可通过第二连接件连接。
第一针头1211与第二针头1212呈V字型连接，第一顶杆1221与第二顶杆1222呈V字型连接。在其他实施例中，第一针头1211与第二针头1212平行且第一针头1211的近端与第二针头1212的近端通过第一连接件1217连接，第一针头1211与第二针头1212可视为呈U字型连接；第一顶杆1221与第二顶杆1222平行且第一顶杆1221的近端与第二顶杆1222的近端通过第二连接件连接，第一顶杆1221与第二顶杆1222可视为呈U字型连接。
拖曳组件400用于拖曳待缝合部位的组织，使穿刺组件120在穿刺时，待缝合部位的组织不会过度变形而影响缝合效果。请一并参阅图5-图6，拖曳组件400包括相互连接的左盘410和第三连接件420，第三连接件420的近端与第二输送钢缆500的远端连接，拖曳组件400从第二鞘管600的近端贯穿第二鞘管600。左盘410具有弹性和形状记忆性，左盘410收束在第二鞘管600内时呈直线状(请参阅图5)，左盘410未收束在第二鞘管600内时为盘状体(请参阅图6)，优选地，左盘410未收束在第二鞘管600内时为具有镂空的盘状体，且双头穿刺针121的远端可穿透左盘410。左盘410的整体形状可以为圆形、方形、菱形等，形状不限，左盘410上的镂空形状也不限，只要使双头穿刺针121的远端能够穿透左盘410即可。第三连接件420包括若干根导丝421，导丝421的远端与左盘410连接，导丝421的近端与第二输送钢缆500的远端连接。若干根导丝421间隔排列构成第三连接件420。在其他实施例中，若干根导丝421通过编织构成第三连接件420。
左盘410可由镍钛合金管经切割后热定型而成。第三连接件420的两端可以采用焊接、编织打结、胶粘等方式，分别与左盘410和第二输送钢缆500的远端进行连接。导丝421为柔性金属丝，例如镍钛丝、不锈钢丝、PET线、PA线、PTFE线、PE线或者超高分子量聚乙烯线等，因而具有很好的柔韧性，可以任意弯折，同时具有一定的强度，可以承受40N以上的进鞘拉力。
本实施例中采用具有两个腔体的第一鞘管300，将医用缝合装置100和拖曳组件400分隔开，避免两者在第一鞘管300内的互相干涉所带来的不便和风险。在其他实施例中，第一鞘管300也可以为单腔管，医用缝合装置100与第一输送钢缆200连接后，医用缝合装置100从第一鞘管300的近端贯穿第一鞘管300，拖曳组件400与第二输送钢缆500连接并收束在第二鞘管600的腔体内后，第二鞘管600从第一鞘管300的近端贯穿第一鞘管300。
在其他实施例中，医用缝合系统10可不包括拖曳组件400和第二输送钢缆500，医用缝合装置100与第一输送钢缆200连接后，在第一鞘管300的输送下到达体内靶区即可对靶区组织进行缝合。
以治疗卵圆孔未闭为例，但医用缝合装置100并不仅限于治疗卵圆孔未闭。 请参阅图7，方框所示为卵圆孔未闭的体内组织结构示意图，卵圆孔未闭处的两片心房壁有一重叠区域，可通过医用缝合装置100在该重叠区域进行缝合即可将两片心房壁缝合在一起，以达到阻断卵圆孔处血液分流的目的。
请一并参阅图8-图11，缝合过程包括如下步骤：
1、将第一输送钢缆200的远端穿过固定件124近端的开孔并与固定块123的近端连接；将第一卡扣112从第一针头1211的远端穿进第一腔体1213内，第二卡扣113从第二针头1212的远端穿进第二腔体1214内，并使缝合线111位于第一开孔1215和第二开孔之间；之后，将穿刺组件120的远端从第一鞘管300的近端穿进第三腔体310内，并将其推送至第一鞘管300的远端；
2、将具有锥头鞘芯的第二鞘管600(图未示)从第一鞘管300的近端伸入第一鞘管300的第四腔体320内，并将其推送至第一鞘管300的远端，且鞘芯的远端从第二鞘管600的远端伸出；
3、借助支气管镜等设备，通过股静脉穿刺后，将第一鞘管300的远端输送至右心房；将鞘芯和第二鞘管600从第一鞘管300的远端推出，使鞘芯和第二鞘管600插入卵圆孔至左心房；撤出鞘芯；
4、将第二输送钢缆500的远端与第三连接件420的近端连接；之后，将左盘410第二鞘管600的近端伸入第二鞘管600的腔体内，并将左盘410推送至第二鞘管600的远端；将第二鞘管600从第一鞘管300的近端伸入第四腔体320内，并将第二鞘管600推送至第一鞘管300的远端；
5、朝远端推送第二鞘管600，以使压缩状的左盘410的近端伸出第一鞘管300的远端；后撤第二鞘管600，使压缩状态的左盘410逐渐从第二鞘管600的腔体内推出进行释放，释放后的左盘410呈展开状；朝近端慢慢拉动第二输送钢缆500，以使左盘410紧贴卵圆孔；固定第二输送钢缆500，以使第二输送钢缆500相对鞘管不进行移动；
6、朝远端推送第一输送钢缆200，以使双头穿刺针121的远端对准卵圆孔的待缝合部位进行穿刺，直至第一针头1211和第二针头1212的针头端完全穿过房间隔；固定第一输送钢缆200，以使其相对于第一鞘管300不进行移动；
7、朝远端推送第二鞘管600使其穿过卵圆孔；后撤第二输送钢缆500，以 使左盘410被收束在第二鞘管600的腔体内；之后，撤出第二鞘管600至体外；
8、将第一输送钢缆200朝远端推送，第一输送钢缆200的远端带动固定块123和顶针122同步朝远端移动，此时，第一顶杆1221的远端在第一腔体1213内推着第一卡扣112朝第一针头1211的末端移动，第二顶杆1222的远端在第二腔体1214内推着第二卡扣113朝第二针头1212的末端移动，同时，缝合线111随着第一卡扣112和第二卡扣113的移动在第一卡扣112和第二卡扣113之间朝远端移动；当第一卡扣112的远端被推出第一腔体1213、第二卡扣113的远端被推出第二腔体1214后，朝近端推送外管125以后撤双头穿刺针121，此时，第一卡扣112和第二卡扣113均留在左心房并挂在心房壁上，缝合线111的大部分留在右心房，从而将卵圆孔处两片心房壁缝合在一起；
9、后撤外管125以使穿刺组件120收束在第一鞘管300内；将第一鞘管300及收束在第一鞘管300内的穿刺组件120、第一输送钢缆200撤出体外，从而完成一次缝合。
需要说明的是，可采用相同的操作将另一线组件110缝合在该重叠区域，以增强两片隔膜之间的缝合紧密度。重复操作的次数可根据实际需要而定，所需线组件110的个数也根据重复操作的次数而定。
请参阅图12，缝合线111的长度为d，第一针头1211的远端端部与第二针头1212的远端端部之间的距离为D，由于缝合线111位于第一针头1211和第二针头1212之间且呈直线状，故d小于D，因而在缝合后，缝合线111会在两个穿刺点之间拉紧从而保证缝合效果。可以理解，通过调整第一针头1211和第二针头1212之间的夹角，以及缝合线111在第一针头1211和第二针头1212之间的初始安装位置，可调节缝合线111在两个穿刺点之间的松紧程度。
实施例1的医用缝合装置100，采用介入缝合手段通过穿刺组件120和线组件110的配合，能够简单、快捷地完成体内缝合操作，避免了例如治疗卵圆孔未闭时的开胸手术，极大幅度地减少了手术风险和创口面积，有利于术后恢复。其次，缝合线111无需在体内进行打结操作，降低了手术难度，节省了手术时间，减轻病人的疼痛。再次，在缝合后，留入体内的仅仅为线组件110，由于线组件110的体积较小，能够大大降低植入物在体内带来并发症的风险，也不会 对周围组织带来损伤，且由于缝合线111承受的拉力较小，因而产生疲劳失效的风险也较低。
实施例2
实施例2与实施例1相同的部分在此不再赘述，其区别主要在于，请一并参阅图13-图14，第一卡扣712为管状，第二卡扣713为管状，缝合线711的一端与第一卡扣712的中部连接，另一端与第二卡扣713的中部连接，且第一顶杆7221的外径小于第一卡扣712的内径，第二顶杆7222的外径小于第二卡扣713的内径，使得第一顶杆7221的远端能够伸入第一卡扣712的腔体内，第二顶杆7222的远端能够伸入第二卡扣713的腔体内，第一顶杆7221的远端为针头状，第二顶杆7222的远端为针头状。也就是说，第一顶杆7221的远端作用与第一实施例中的第一针头1211的穿刺作用相同，第二顶杆7222的远端作用与第一实施例中的第二针头1212的穿刺作用相同，也可以理解为，第一顶杆7221即为本实施例中的实心的第一针头7211，第二顶杆7222即为本实施例中的实心的第二针头7212。
进一步地，第一针头7211上未设有第一开孔1215，第二针头7212上未设有第二开孔，且第一卡扣712的外径大于或等于第一针头7211的内径，第二卡扣713的外径大于或等于第二针头7212的内径，第一卡扣712的近端较第一针头7211的远端靠近医用缝合装置的远端，第二卡扣713的近端较第二针头7212的远端靠近医用缝合装置的远端。
需要说明的是，本实施例中，第一针头7211的远端可保留为实施例1中的针头状，也可以不为针头状，第二针头7212的远端也可保留为实施例1中的针头状，也可不为针头状。还可以理解的是，其他实施例中，第一针头7211及第二针头7212也可以省略不要。
实施例2的医用缝合装置在进行缝合时，缝合原理为：通过第一鞘管300将医用缝合装置的远端输送至右心房内的卵圆孔处；后撤第一鞘管300以使医用缝合装置的远端从第一鞘管300中伸出；朝远端推送第一输送钢缆200，以使第一顶杆7221的针头端和第二顶杆7222的针头端穿刺房间隔，直至第一卡扣 712和第二卡扣713完全进入左心房；保持固定件相对于卵圆孔的位置不变，后撤第一输送钢缆200以使固定块723朝近端移动至固定件的近端，此时，第一卡扣712和第二卡扣713自然脱落至左心房内，从而完成缝合操作，缝合效果与实施例1的缝合效果相同。
请参阅图15，缝合线711的长度为d，第一顶杆7221的远端端部与第二顶杆7222的远端端部之间的距离为D，由于缝合线711位于第一顶杆7221和第二顶杆7222之间且呈直线状，故d小于D，因而在缝合后，缝合线711会在两个穿刺点之间拉紧从而保证缝合效果。可以理解，通过调整第一顶杆7221和第二顶杆7222之间的夹角，以及缝合线711在第一顶杆7221和第二顶杆7222之间的初始安装位置，可调节缝合线711在两个穿刺点之间的松紧程度。
实施例3
实施例3与实施例1相同的部分在此不再赘述，其区别主要在于，第一卡扣812在被收束在第一腔体内时为杆状，在从第一针头的远端滑出后呈平面展开状(请参阅图16)，第二卡扣813在被收束在第二腔体内时为杆状，在从第二针头的远端滑出后呈平面展开状(请参阅图16)。第一卡扣812和第二卡扣813在展开后的形状不限，用于将缝合线的两端固定在穿刺点的与缝合线的主体部分相对的一端，只要在缝合后不易于从穿刺点的一端移动到另一端即可。在其他实施例中，与实施例3中线组件配合使用的穿刺组件，也可以为实施例2中的穿刺组件。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改 进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (17)

  1. 一种医用缝合装置，其特征在于，所述医用缝合装置包括穿刺组件，所述穿刺组件包括第一针头及第二针头，所述第一针头的针尖及所述第二针头的针尖均始终朝所述穿刺组件的远端延伸。
  2. 根据权利要求1所述的医用缝合装置，其特征在于，所述医用缝合装置还包括线组件，所述线组件包括缝合线、第一卡扣和第二卡扣，所述缝合线的一端与所述第一卡扣连接，另一端与所述第二卡扣连接，所述第一卡扣与所述第一针头相连，所述第二卡扣与所述第二针头相连，所述缝合线夹设于所述第一针头与所述第二针头之间。
  3. 根据权利要求2所述的医用缝合装置，其特征在于，所述穿刺组件包括双头穿刺针和顶针，所述双头穿刺针包括所述第一针头和所述第二针头，所述第一针头具有第一腔体且两端开口，所述第二针头具有第二腔体且两端开口，所述第一针头的近端与所述第二针头的近端连接且保持所述第一针头的近端和所述第二针头的近端均开口，所述第一针头的与所述第二针头相对的一侧设有第一开孔，所述第二针头上与所述第一开孔相对地设有第二开孔，所述第一开孔的远端延伸至所述第一针头的远端端部，所述第二开孔的远端延伸至所述第二针头的远端端部；所述顶针包括第一顶杆和第二顶杆，所述第一顶杆的近端与所述第二顶杆的近端连接，所述第一顶杆的远端从所述第一针头的近端伸入所述第一腔体内，所述第二顶杆的远端从所述第二针头的近端伸入所述第二腔体内；所述第一卡扣收容于所述第一腔体内，所述第二卡扣收容于所述第二腔体内，且所述缝合线位于所述第一开孔和所述第二开孔之间。
  4. 根据权利要求3所述的医用缝合装置，其特征在于，所述穿刺组件还包括固定件和外管，所述固定件具有一腔体且近端设有一开孔，所述外管的远端与所述固定件的近端连接，且所述外管的内径大于所述固定件近端开孔的直径，所述双头穿刺针的近端与所述固定件的远端连接，所述顶针的近端收容于所述固定件的腔体内。
  5. 根据权利要求4所述的医用缝合装置，其特征在于，所述穿刺组件还包括固定块，所述固定块收容于所述固定件的腔体内，所述顶针的近端收容于所 述固定件的腔体内且与所述固定块的远端连接。
  6. 根据权利要求3所述的医用缝合装置，其特征在于，所述医用缝合装置还包括第一连接件，所述第一针头的近端与所述第二针头的近端通过所述第一连接件连接。
  7. 根据权利要求6所述的医用缝合装置，其特征在于，所述医用缝合装置还包括第二连接件，所述第一顶杆的近端与所述第二顶杆的近端通过所述第二连接件连接。
  8. 根据权利要求1-7任一项所述的医用缝合装置，其特征在于，所述第一针头与所述第二针头呈V字型或U字型连接。
  9. 根据权利要求7所述的医用缝合装置，其特征在于，所述第一针头与所述第二针头平行，所述第一顶杆与所述第二顶杆平行。
  10. 根据权利要求3所述的医用缝合装置，其特征在于，所述第一卡扣在被收束在所述第一腔体内时为杆状，在从所述第一针头的远端滑出后呈平面展开状，所述第二卡扣在被收束在所述第二腔体内时为杆状，在从所述第二针头的远端滑出后呈平面展开状。
  11. 根据权利要求2所述的医用缝合装置，其特征在于，所述穿刺组件包括第一顶杆及与所述第一顶杆相连的第二顶杆，所述第一顶杆为所述第一针头，所述第二顶杆为所述第二针头；所述第一卡扣为管状，且所述第一卡扣套设于所述第一顶杆上，所述第二卡扣为管状，且所述第二卡扣套设于所述第二顶杆上。
  12. 一种医用缝合系统，其特征在于，包括第一输送钢缆和第一鞘管，还包括上述权利要求1所述的医用缝合装置，所述第一输送钢缆的远端与所述穿刺组件相连，所述穿刺组件收容于所述第一鞘管。
  13. 根据权利要求12所述的医用缝合系统，其特征在于，所述医用缝合系统还包括拖曳组件、第二输送钢缆和第二鞘管，所述拖曳组件包括相互连接的左盘和第三连接件，所述第三连接件的近端与所述第二输送钢缆的远端连接，所述拖曳组件从所述第二鞘管的近端贯穿所述第二鞘管，且在输送时所述第二鞘管从所述第一鞘管的近端贯穿所述第一鞘管。
  14. 根据权利要求13所述的医用缝合系统，其特征在于，所述左盘收束在所述第二鞘管内时呈直线状，所述左盘未收束在所述第二鞘管内时为具有镂空的盘状体，且所述穿刺组件的远端可穿透所述左盘。
  15. 根据权利要求13所述的医用缝合系统，其特征在于，所述第三连接件包括若干根导丝，所述导丝的远端与所述左盘连接，所述导丝的近端与所述第二输送钢缆的远端连接。
  16. 根据权利要求15所述的医用缝合系统，其特征在于，所述导丝间隔排列或通过编织构成所述第三连接件。
  17. 根据权利要求13-16任一项所述的医用缝合系统，其特征在于，所述第一鞘管具有相互平行的第三腔体和第四腔体，所述医用缝合装置从所述第一鞘管的近端贯穿所述第一鞘管，所述第二鞘管从所述第一鞘管的近端贯穿所述第一鞘管。
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