WO2018129691A1 - 一种隔离装置的回收系统及预装载、后装载的介入系统 - Google Patents

一种隔离装置的回收系统及预装载、后装载的介入系统 Download PDF

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Publication number
WO2018129691A1
WO2018129691A1 PCT/CN2017/070966 CN2017070966W WO2018129691A1 WO 2018129691 A1 WO2018129691 A1 WO 2018129691A1 CN 2017070966 W CN2017070966 W CN 2017070966W WO 2018129691 A1 WO2018129691 A1 WO 2018129691A1
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WO
WIPO (PCT)
Prior art keywords
outer tube
recovery
distal end
sheath
locking
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Application number
PCT/CN2017/070966
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English (en)
French (fr)
Inventor
梅奇峰
孙智慧
张瑞岩
李寅
Original Assignee
上海心瑞医疗科技有限公司
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Application filed by 上海心瑞医疗科技有限公司 filed Critical 上海心瑞医疗科技有限公司
Priority to PCT/CN2017/070966 priority Critical patent/WO2018129691A1/zh
Publication of WO2018129691A1 publication Critical patent/WO2018129691A1/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
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord

Definitions

  • the present invention relates to the field of medical devices, and in particular to an apparatus for performing an interventional operation of a cardiac isolation device, and more particularly to a recovery system for an isolation device; and an intervention system preloaded with an isolation device and a rear loading Intervention system.
  • heart failure one of the final outcomes of all heart diseases, has always threatened human health.
  • CN103800045A provides a medical cardiac isolation device that includes a support frame and a base.
  • the support frame is composed of a plurality of developable devices, a plurality of fixed tips, a plurality of rib-shaped joint rods and a plurality of curved surfaces, wherein each adjacent two rib-shaped joint rods are connected by a curved surface to form an inverted umbrella shape
  • the support frame and the umbrella of the support frame are turned outwards around the periphery, and one end of the rib-shaped joint rod is connected with a corresponding fixed tip and a fixed tip is placed on the umbrella edge of the support frame, and each fixed tip is provided with a developable device, and each The rib-shaped section rod and the fixed tip are covered with a polymer isolation film, and the bottom of the support frame is connected with the base, and the bottom of the base is in a plane.
  • the isolation device can be delivered into the human heart by a percutaneous intervention using a sheath and delivery system to improve ventricular remodeling and cardiac function in the patient.
  • a percutaneous intervention using a sheath and delivery system to improve ventricular remodeling and cardiac function in the patient.
  • the product size is too small to meet the disease demand or other reasons, it is necessary to surgically remove the isolation device, which brings a great trauma to the patient.
  • the present invention provides a recovery system for an isolation device and an intervention system for preloading and postloading, which can be used for converging and recovering an unsuccessful release device by means of a catheter. .
  • a recycling system for an isolation device comprising a suture for converging and a connected wire head, the recovery system comprising: for transporting within the sheath Recycling device and catching device, wherein:
  • the recovery device includes a recovery conduit transported within the sheath, and a ram within the recovery conduit for resisting the isolation device;
  • the catching device is configured to: when the release device is unsuccessfully released, the suture line of the isolation device is grasped and converged by the catching device and the recovery device.
  • an elastic flaring structure is disposed at a distal end of the recovery conduit, and the flaring structure is configured to release the flaring structure when the flaring structure extends out of the sheath tube When the flared structure is located within the sheath, the flared structure is compressed within the sheath.
  • a quick exchange port is further disposed on a sidewall of the recovery conduit; the quick exchange port extends along an axial direction of the recovery conduit.
  • the grasping device comprises an outer tube having a proximal end and a distal end, a notch is disposed on the tube wall of the outer tube; and a locking push rod extending from the proximal end of the outer tube, The locking pusher is configured to extend into a position in the outer tube that exceeds the indentation; a gap between the locking push rod and the outer tube at the gap location is configured to prevent passage of the thread of the suture.
  • the grasping device comprises an outer tube having a proximal end and a distal end; further comprising an occlusion portion, the occlusion portion partially blocking the distal end of the outer tube and forming a notch at the distal end;
  • the utility model further comprises a locking rod radially connected in the outer tube, wherein a side wall of the locking rod is provided with a groove extending along an axial direction thereof, and a locking relationship between the locking rod and the outer tube is as follows: the locking The rod has a free state of rotation to expose the recess in the notch position; and a locked state of rotating the recess to the position of the occlusion portion, in the locked state, between the distal end of the locking rod and the occluding portion
  • the gap is configured to block the passage of the thread of the suture.
  • the grasping device comprises an outer tube having a proximal end and a distal end, the distal end of the outer tube having a blade face, and a tightening line for pre-attaching the suture through the outer tube ;
  • Also includes A push rod extending from the proximal end of the outer tube, the push rod extending from the distal end of the outer tube is provided with a plug for engaging the blade surface.
  • the outer tube is entirely made of a metal material, and an outer wall of the distal end of the outer tube is tapered to form the blade surface.
  • the outer tube comprises a resin tube, and the blade surface is formed on a metal nozzle integrally connected with the resin tube.
  • the grasping device comprises an outer tube substantially at a central position of the isolation device and having a proximal end and a distal end, and further comprising a locking guide wire extending from the proximal end of the outer tube, the locking guide wire extending
  • the distal end of the outer tube has a curved portion bent toward the outer side, and a distal end of the locking guide wire is provided with a hook body, the hook body being disposed by the curved portion to the suture position of the isolating device, and the bending portion The bend is configured to deform to match the shape of the outer tube when the guide wire is pulled back.
  • the end of the conveyor is provided with a threaded connection for threaded connection to the isolating device.
  • an interventional system preloaded with an isolation device, the isolation device comprising a suture for converging and a connected wire end, the interventional system comprising an implantation system and a recovery system;
  • the implant system includes a sheath and a conveyor for transporting the isolation device within the sheath;
  • the recovery system includes: a recovery device for transporting within the sheath and a capture device, wherein:
  • the recovery device includes a recovery conduit transported within the sheath, and a ram within the recovery conduit for resisting the isolation device;
  • the suture of the isolation device is preloaded on the capture device, and the capture device is configured to: when the conveyor is successfully released, the capture device unloads the suture of the isolation device; when the conveyor is released Upon success, the capture device is withdrawn and the opening of the isolation device is converged.
  • an elastic flaring structure is disposed at a distal end of the recovery conduit, and the flaring structure is configured to release the flaring structure when the flaring structure extends out of the sheath tube When the flared structure is located within the sheath, the flared structure is compressed within the sheath.
  • a quick exchange port is further disposed on a sidewall of the recovery duct.
  • the quick exchange port extends along the axial direction of the recovery conduit.
  • the grasping device comprises an outer tube having a proximal end and a distal end, a notch is disposed on the tube wall of the outer tube; and a locking push rod extending from the proximal end of the outer tube, The locking pusher is configured to extend into a position in the outer tube that exceeds the indentation; a gap between the locking push rod and the outer tube at the gap location is configured to prevent passage of the thread of the suture.
  • the grasping device comprises an outer tube having a proximal end and a distal end; further comprising an occlusion portion, the occlusion portion partially blocking the distal end of the outer tube and forming a notch at the distal end;
  • the utility model further comprises a locking rod radially connected in the outer tube, wherein a side wall of the locking rod is provided with a groove extending along an axial direction thereof, and a locking relationship between the locking rod and the outer tube is as follows: the locking The rod has a free state of rotation to expose the recess in the notch position; and a locked state of rotating the recess to the position of the occlusion portion, in the locked state, between the distal end of the locking rod and the occluding portion
  • the gap is configured to block the passage of the thread of the suture.
  • the grasping device comprises an outer tube having a proximal end and a distal end, the distal end of the outer tube having a blade face, and a tightening line for pre-attaching the suture through the outer tube
  • a push rod extending from the proximal end of the outer tube, the push rod extending from the distal end of the outer tube is provided with a plug for mating with the blade face.
  • the outer tube is entirely made of a metal material, and an outer wall of the distal end of the outer tube is tapered to form the blade surface.
  • the outer tube comprises a resin tube, and the blade surface is formed on a metal nozzle integrally connected with the resin tube.
  • the end of the conveyor is provided with a threaded connection for threaded connection to the isolating device.
  • an interventional system for post-loading of an isolation device comprising a suture for converging and a connected wire head
  • the interventional system comprising an implantation system and a recovery system
  • the implant system includes a sheath tube and a conveyor for transporting the isolation device within the sheath tube;
  • the recovery system includes: a recovery device for transporting within the sheath tube and a capture device, wherein:
  • the recovery device includes a recovery conduit transported within the sheath, and a ram within the recovery conduit for resisting the isolation device;
  • the recovery device and the catching device are configured to: when the release device is unsuccessfully released, transport the grasping device and the recovery device in the sheath tube to grasp and consolidate the suture of the isolation device.
  • an elastic flaring structure is disposed at a distal end of the recovery conduit, and the flaring structure is configured to release the flaring structure when the flaring structure extends out of the sheath tube When the flared structure is located within the sheath, the flared structure is compressed within the sheath.
  • a quick exchange port is further disposed on a sidewall of the recovery duct.
  • the quick exchange port extends along the axial direction of the recovery conduit.
  • the grasping device comprises an outer tube substantially at a central position of the isolation device and having a proximal end and a distal end, and further comprising a locking guide wire extending from the proximal end of the outer tube, the locking guide wire extending
  • the distal end of the outer tube has a curved portion bent toward the outer side, and a distal end of the locking guide wire is provided with a hook body, the hook body being disposed by the curved portion to the suture position of the isolating device, and the bending portion The bend is configured to deform to match the shape of the outer tube when the guide wire is pulled back.
  • the hardness of the hook body on the locking guide wire is greater than the hardness of the remaining position on the locking guide wire.
  • the hook body on the locking guide wire is made of a different material from the rest of the position.
  • the jack and the catching device are transported within the same chamber of the recovery conduit.
  • the recovery conduit has a plurality of chambers extending axially along the recovery conduit, the ram and the capture device being transported within different chambers of the recovery conduit.
  • the end of the conveyor is provided with a threaded connection for threaded connection to the isolating device.
  • the recovery system of the isolation device of the invention and the pre-loading and post-loading intervention system can conceal and recover the unsuccessful release device by means of a catheter, thereby avoiding the use of the surgical method to the isolation device. Recycling reduces damage to the patient.
  • FIG. 1 is a schematic structural view of an isolation device in the prior art.
  • Figure 2 is a schematic illustration of the operation of the recovery system of the present invention.
  • Figure 3 is a schematic view showing the structure of the recovery apparatus of the present invention.
  • Figure 4 is a view showing the cooperation of the catching device and the isolating device according to the first embodiment of the present invention.
  • Figure 5 is a partial enlarged view of the catching device of Figure 4 in a notched position.
  • Figure 6 is a partial enlarged view of another preferred embodiment of the catching device of Figure 4.
  • Figure 7 is a view showing the cooperation of the catching device and the isolating device of the second embodiment of the present invention.
  • Figure 8 is a schematic view showing the structure of a catching device according to a third embodiment of the present invention.
  • Fig. 9 is a structural schematic view showing another angle of the catching device of the third embodiment of the present invention.
  • Figure 10 is a schematic view showing the structure of a catching device according to a fourth embodiment of the present invention.
  • Figure 11 is a schematic view showing the structure of the locking guide wire of Figure 10.
  • Figure 12 is a schematic view showing the structure of a catching device according to a fifth embodiment of the present invention.
  • Figure 13 is a schematic illustration of the recovery system of the present invention in the recovery of the isolation device.
  • Figure 14 is a schematic illustration of the construction of the interventional system of the present invention.
  • FIG. 1 shows a schematic structural view of a prior art isolation device 1 including an umbrella structure supported above a base 1b, the umbrella structure including a plurality of support bars arranged on a circumference, the plurality The shape of the support rod arrangement is similar to the rib structure. Also included is a film 1a fixed to the plurality of support rods, the film 1a forming an umbrella-like structure with one end closed and one end gradually opened under the support of the support rod. A loop 1c is provided at the edge of the open end of the film 1a, and the ends of the stitch 1c are joined together to form a thread 1d.
  • the enlarged thread head 1d can also be formed at the end position of the suture 1c by knotting or other means known to those skilled in the art.
  • the line head 1d can be set as many as needed.
  • the open end of the film 1a can be bundled by the suture 1c.
  • the structure of the isolation device 1 and its working principle are all common knowledge of those skilled in the art, and will not be specifically described herein.
  • the present invention provides an interventional system for implanting the above-described isolation device 1 at a corresponding location in the heart, including an implantation system and a recovery system.
  • the above-described isolation device 1 can be implanted into the corresponding position of the ventricle 2 by the implantation system to make it function, referring to FIG. 2; when it is required to be taken out of the ventricle 2, it can be recovered by the recovery system of the present invention, Refer to Figure 13.
  • the implant system of the present invention can include a sheath 3 and a conveyor 7 for transporting the isolation device 1 within the sheath 3, the end of the conveyor 7 having a connection 70 through which the connection 70 is The connection of the conveyor 7 to the isolating device 1 is achieved.
  • the isolating device 1 is loaded into the sheath 3 together with the conveyor 7, the isolating device 1 is transported to a predetermined position by the conveyor 7, and the isolating device 1 is passed out from the distal end of the sheath 3. Thereby, the isolating device 1 is released; after that, the conveyor 7 is detached from the isolating device 1 to complete the implantation of the isolating device 1.
  • the connecting portion 70 of the conveyor 7 of the present invention may be a threaded structure by which a threaded connection is made to the isolating device 1 to facilitate disengagement of the conveyor 7 from the isolating device 1.
  • the recovery system of the present invention comprises a sheath 3 and a recovery device 4 and a catching device 6 located in the sheath 3.
  • the recovery device 4 and the capture device 6 can be operated in the sheath 3 to complete the isolation. Recycling of device 1.
  • a plurality of chambers extending in the axial direction of the sheath tube 3 may be disposed in the sheath tube 3.
  • the recovery device 4 and the catching device 6 may be disposed in the same chamber of the sheath tube 3, or may be disposed in the same chamber. Different chambers of the sheath 3.
  • FIG 3 shows a schematic view of the structure of the recovery device 4 of the present invention, which includes a recovery conduit 40 for transport within the sheath 3, and a ram 43 located within the recovery conduit 40.
  • the role of the jack 43 is When the suture 1c of the isolating device 1 is grasped by the catching device 6, the jack 43 is placed at the center of the isolating device 1 so that the catching device 6 grasps the suture 1c of the isolating device 1 for converging.
  • the ejector 43 of the present invention can also be replaced by the conveyor 7 itself, that is to say, by the cooperation of the conveyor 7 described above with the catching device 6, the splicing of the isolating device 1 can also be achieved.
  • the ejector rod 43 and the catching device 6 of the present invention are preferably respectively connected by a plurality of segments having different hardnesses.
  • the ejector rod 43 and the middle portion of the catching device 6 may be made of a soft material or structure, so that the The section is bent to pass through the sheath 3.
  • the middle section of them may be a spiral tube structure or the like which is easy to bend.
  • the positions of the apex 43 and the catching device 6 at both ends can be made of a hard material to meet the operational requirements.
  • the distal end of the plunger 43 preferably has a ball-end structure by which the distal end of the plunger 43 can be smoothly fitted to the center of the spacer.
  • the recovery conduit 40 can extend from the proximal end of the sheath 3 and partially exit from the distal end of the sheath 3. Wherein the distal end of the recovery duct 40 is provided with a resilient flared structure 41, and the flared structure 41 is configured to release the flared structure 41 when the flared structure 41 extends out of the sheath 3. When the flared structure 41 is located within the sheath 3, the flared structure 41 is compressed within the sheath 3.
  • the flared structure 41 of the present invention has a flared shape in a released state, and the flared structure 41 can be made of an elastic material to have a certain elastic deformation capability.
  • the flared structure 41 may be a self-elastic polymer material well known to those skilled in the art.
  • a film type polymer material may be used, which may be formed by one molding or shear molding. Made by the way.
  • the flared structure 41 may be made of a metal mesh material, which may be formed by braiding or laser cutting.
  • the recovery duct 40 of the present invention may be made of the same material as the flared structure 41 or may be of a different material. Since the recovery duct 40 mainly functions as a transport and connection, it may be made of a common metal material or a polymer material.
  • the recovery conduit 40 and the flared structure 41 are loaded into the sheath tube 3 together, at which time the flared structure 41 is compressed so that it can be transported together with the recovery conduit 40 within the sheath tube 3; Flared structure 41 from the far side of the sheath 3 After the end is worn out, the flaring structure 41 can be released under its own restoring force due to the loss of the limitation of the sheath tube 3, thereby facilitating the reception of the isolating device 1.
  • the recovery conduit 40 can be withdrawn from the sheath 3 to complete the recovery of the isolation device 1.
  • the ram 43 of the present invention can be inserted through the recovery conduit 40, which is primarily used to cooperate with the catching device 6 to complete the converging of the isolating device 1.
  • a quick exchange port 42 is further provided on the side wall of the recovery duct 40.
  • the quick exchange port 42 may be circular or square, preferably extending along the axial direction of the recovery conduit 40, with reference to FIG.
  • the quick exchange port 42 is disposed on the side wall of the recovery conduit 40 such that the desired components can pass through the quick exchange port 42 through the flared structure 41 of the recovery conduit 40 to facilitate operation of the associated instrument.
  • the side wall of the recovery duct may not be provided with a quick exchange port, and the relevant components directly pass through the same chamber or different chambers of the recovery duct.
  • the catching device 6 of the present invention can also be transported within the recovery conduit 40, which can be transported with the ram 43 in the same chamber of the recovery conduit 40.
  • the recovery conduit 40 preferably has a plurality of chambers distributed axially along the recovery conduit 40, the ram 43 and the capture device 6 being located in different chambers.
  • 4 to 12 are schematic views showing five different implementation structures of the catching device 6 of the present invention.
  • the catching device 6 includes an outer tube 610 that can serve as a main portion of the catching device 6 in the sheath 3 or the recovery conduit. Delivery within 40.
  • the outer tube 610 has a proximal end and a distal end.
  • a notch 612 is provided in the wall of the outer tube 610, and the notch 612 may be in the shape of a rectangle, a circle, or other shape known to those skilled in the art.
  • the capture device 6 of the present invention further includes a locking push rod 611 extending from the proximal end of the outer tube 610, and the locking push rod 611 is configured to extend into the outer tube 610 beyond the gap 612;
  • the gap between the locking push rod 611 and the outer tube 610 at the position of the notch 612 is configured to prevent the thread end 1d of the suture 1c from passing.
  • the outer tube 610 of the present invention may be made of a metal material, and the locking push rod 611 may be in the form of a filament or a sheet, which may be made of a metal material.
  • a locking push rod 611 is introduced from the proximal end of the outer tube 610 and extends along the extending direction of the outer tube 610 to a position beyond the gap 612, so that The suture 1c can be caught between the locking push rod 611 and the inner wall of the outer tube 610 at the position of the notch 612. Since the size of the wire end 1d is much larger than the size of the suture 1c, the wire end 1d does not always pass between the locking push rod 611 and the outer tube 610 during the pulling of the suture 1c.
  • the notch 612 of the present invention is preferably disposed adjacent the distal end of the outer tube 610 to facilitate grasping of the isolation device 1.
  • the locking push rod 611 is pulled out to expose the notch 612 of the outer tube 610, the suture 1c adjacent to the position of the head 1d is placed on the notch 612, and the suture 1c is attached to the outer tube 610 as much as possible.
  • the locking push rod 611 is pushed and the distal end thereof is passed over the notch 612 of the outer tube 610, which presses the suture 1c between the locking push rod 611 and the outer casing 610.
  • the loading of the suture 1c with the catching device 6 is achieved.
  • the ejector rod 43 of the recovery device 4 is placed at the center of the isolation device 1, and the outer tube 610 and the suture 1c are extracted outward, thereby closing the opening of the isolation device 1, for reference. Figure 13; Finally, with the control of the ejector 43 and the outer tube 610, the confined isolation device 1 is moved into the recovery conduit 40 or the flared structure 41, and the isolation device 1 is removed by retracting the recovery conduit 40.
  • the distal end of the outer tube 610 may be closed or non-closed.
  • the distal end of the outer tube 610 preferably has a curved surface or a spherical surface, so that the distal end of the outer tube 610 can be prevented from causing damage to the human body.
  • the distal end of the outer tube 610 is made of an elastic polymer material.
  • the distal end of the outer tube 610 and the remaining portion of the outer tube 610 may be of different materials and may be joined together by subsequent assembly.
  • the catching device 6 of the present invention unloads the isolator device 1, it is only necessary to retract the locking push rod 611 and expose the notch 612 of the outer tube 610 to release the suture 1c.
  • the notch 612 of the outer tube 610 of the present invention may also be provided with two, respectively, and the two thread ends on the suture 1c are loaded by two notches 612 positions, which can further ensure the loading of the suture 1c and the catching device. Reliability.
  • FIG. 7 is a schematic view showing the structure of a second embodiment of the grasping device of the present invention, the catching device comprising an outer tube 620 which can serve as a main portion of the catching device in the sheath 3 or the recovery conduit 40 Delivery inside.
  • the outer tube 620 has a proximal end and a distal end. Among them, The distal end of the outer tube 620 has a blade face 622 that can be distributed in the circumferential direction of the distal end of the outer tube 620.
  • the outer tube 620 of the present invention may be entirely made of a metal material, and the outer wall of the distal end of the outer tube 620 is tapered to form the blade surface 622.
  • the outer tube 620 may also be made of a non-metallic material.
  • the outer tube 620 may include a resin tube, and the blade surface 622 is formed on a metal nozzle integrally connected with the resin tube. That is, the outer tube 620 is formed by connecting a resin tube and a metal nozzle, and the blade surface 622 may be disposed at a metal nozzle position.
  • the capture device of the present invention also includes a tightening wire 624 that passes through the outer tube 620, which may utilize PP, PET material, or other materials well known to those skilled in the art. It extends from the proximal end of the outer tube 620 and exits from the distal end of the outer tube 620. At the time of loading, the tightening wire 624 can be fastened to the suture 1c of the isolator device 1 to effect loading of the catching device 6 and the isolator device 1.
  • the grasping device of the present invention further includes a push rod 621 extending from the proximal end of the outer tube 620.
  • the push rod 621 may be made of a metal material, which may be in the form of a filament or a sheet.
  • the distal end of the push rod 621 extends from the distal end of the outer tube 620, and a plug 623 for mating with the blade surface 622 is coupled to the extended position.
  • the plug 623 is much larger in size than the push rod 621 and may be cylindrical, rounded or otherwise shaped as is known to those skilled in the art.
  • the push rod 621 can be pulled to make the plug 623 and the blade at the distal end of the push rod 621.
  • the faces 622 are brought into contact with each other to cut the tightening wire 624 to complete the unloading of the isolating device 1 and the catching device.
  • the release device fails to be released, the tightening wire 624 and the suture 1c connected to the tightening wire 624 can be pulled, and the opening of the isolating device 1 can be closed by the ejector rod 43 of the recovery device; finally, the ejector 43 is engaged.
  • the control of the outer tube 620 and the tightening line 624 the converging isolation device 1 is moved to the recovery duct 40 or the flared structure 41, and the isolation device 1 is taken out by the withdrawal recovery duct 40.
  • FIGS. 8 and 9 are schematic views showing the structure of a third embodiment of the grasping device of the present invention, the catching device comprising an outer tube 630, which can be used as a main part of the catching device in the sheath 3 or recycled Delivery within the catheter 40.
  • the outer tube 630 has a proximal end and a distal end.
  • a occlusion portion 633 disposed at a distal end of the outer tube 630, the occlusion portion 633 partially blocking the outer tube
  • a notch 634 is formed at a position where the distal end of the outer tube 630 is not blocked.
  • the outer tube of the present invention may be made of a metal material or a non-metal material, and for example, a polymer material may be used.
  • the occluding portion 633 and the outer tube 630 can be obtained by integral molding.
  • the catching device of the present invention further includes a locking rod 631 radially rotatably coupled within the outer tube 630, the locking rod 631 being radially rotatable in the outer tube 630.
  • a blocking portion or a bearing structure or the like may be provided in the outer tube 630.
  • the locking rod 631 of the present invention may be made of a metal material or a polymer material.
  • a groove 632 is provided on a side wall of the lock lever 631. Referring to FIG. 9, the groove 632 extends in the axial direction of the lock lever 631.
  • the locking rod 631 and the outer tube 630 have the following relationship: the locking rod 631 has a free state of rotating to expose the groove 632 at the position of the notch 634; and rotating the groove 632 to the blocking portion In the locked state of position 633, in the locked state, the gap between the distal end of the locking rod 631 and the occluding portion 633 is configured to block the passage of the thread 1d of the suture 1c.
  • the groove 632 of the lock lever 631 can be rotated to a position exposed to the notch 634, as shown in FIG.
  • the suture 1c of the isolating device 1 and the wire end 1d can be inserted into the groove 632 of the locking rod 631 through the notch 634; the locking rod 631 is rotated, and the groove 632 thereon is rotated and blocked.
  • the position of the portion 633 is at this time, the suture 1c is caught in the gap between the distal end of the locking rod 631 and the occluding portion 633, thereby realizing the loading of the suture 1c with the catching device.
  • the shape of the recess 632 of the present invention may be rectangular, semi-circular, or other shapes well known to those skilled in the art.
  • the locking rod 631 can adopt a semi-annular flat tube structure, that is, a circular tube is cut along its axial direction to form a flat tube tube having a semi-annular cross section. Structure.
  • the area of the occlusion portion 633 may be greater than or equal to the area of the notch 634 to facilitate loading the suture 1c of the isolation device 1.
  • FIGS. 10 and 11 are schematic views showing the structure of a fourth embodiment of the grasping device of the present invention, which includes an outer tube 640 substantially at the center of the spacer device 1, which can be used as a main portion of the catching device in the sheath
  • the tube 3 or the recovery conduit 40 is transported.
  • the outer tube 640 has a proximal end and a distal end.
  • a locking guidewire 641 extending from the proximal end of the outer tube 640, the locking guidewire 641 extending from the proximal end of the outer tube 640 and extending therefrom.
  • the locking guide wire 641 protrudes from the distal end of the outer tube 640 with a curved portion 643 bent toward the outside, and a hook body 642 is provided at the distal end of the locking guide wire 641.
  • the hook body 642 is disposed by the curved portion 643 to the position of the suture 1c of the isolating device 1, and the curved portion 643 is configured to deform the curved portion 643 to the outside when the locking guide wire 641 is pulled back.
  • the shape of the tube 640 matches.
  • the outer tube 640 of the present invention extends from the sheath tube 3 or the recovery conduit 40 for subsequent recovery of the isolation device 1 into the recovery conduit 40, which is substantially centered on the isolation device 1 after it has been extended. Since the space at the time of the intervention is too small, in order to extend the hook body 642 to the position of the suture 1c of the isolator 1, the curved portion 643 is provided, and the bending deformation of the curved portion 643 causes the hook body 642 and the suture The wires 1c are as close together as possible so as to grasp the suture 1c by the hooks 642.
  • the grasping device of the present invention firstly needs to load the locking guide wire 641 into the outer tube 640, and at this time, the curved portion 643 can be squeezed to deform, so that the hook body 642 is close to the body of the locking guide wire 641, and Filled in the outer tube 640; when the curved portion 643 is passed out from the distal end of the outer tube 640, under the elastic restoring force of itself, the curved portion 643 is reset, so that the hook body 642 is fitted to the suture of the isolating device 1 1c position.
  • the suture 1c can be grasped by the hook body 642 by a minute operation.
  • the outer tube 640 of the present invention may be made of a metal material or a polymer material.
  • the locking guide wire 641 can also be made of a metal material or a polymer material.
  • the hardness of the hooking body 642 of the locking guide wire 641 is greater than the hardness of the remaining position on the locking guide wire 641.
  • the hook body 642 on the locking guide wire 641 and the remaining positions may be made of different materials or processed through different processes to ensure the hardness of the hook body 642.
  • FIG 12 is a schematic view showing the structure of a fifth embodiment of the grasping device of the present invention.
  • the grasping device employs a longer tightening wire 650, and one end of the tightening wire 650 is passed through the suture of the isolating device. 1c, then fold back.
  • the release device is successfully released, one end of the tightening wire 650 is released, and the tightening wire 650 is pulled out; when the release device is unsuccessfully released, both ends of the tightening wire 650 are simultaneously extracted, and the isolating device is closed. .
  • the invention also provides a method for intervention of a preloading type isolation device, comprising the following steps:
  • the above method is implanted or recovered by pre-loading the suture of the isolation device.
  • the connection between the grasping device and the suture is unloaded, and the grasping device shown in FIG. 4 to FIG. 9 and FIG. Both need to be recycled in a preloaded manner.
  • the present invention also provides an intervention method for a back loading type isolation device, which includes the following step:
  • the method is to recover in a later loading manner, that is to say, when it is judged that the release device is unsuccessfully released, the recovery device and the catching device are fed along the sheath tube, and the grasping device can be used to complete the grasping of the suture line of the isolating device. take.
  • the catching device shown in Figures 10 and 11 is suitable for recycling in this post-loading mode.
  • the interventional system provided by the present invention can also be distinguished as an interventional system preloaded by the isolation device and an interventional system loaded behind the isolation device.
  • the isolation device can be recovered by the recovery device and the capture device, and the recovery method of the catheter can avoid the damage caused by the recovery of the surgery.

Abstract

一种用于隔离装置（1）的回收系统及预装载、后装载的介入系统，隔离装置（1）包括用于收束的缝合线（1c）以及连接的线头（1d），回收系统包括：用于在鞘管（3）内进行输送的回收装置（4）以及抓捕装置（6），回收装置（4）包括在鞘管（3）内输送的回收导管（40），以及位于回收导管（40）内的用于顶住隔离装置（1）的顶杆（43）；抓捕装置（6）被配置为：当隔离装置（1）释放不成功，则通过抓捕装置（6）以及回收装置（4）对隔离装置（1）的缝合线（1c）进行抓取、收束。该回收系统可以避免采用外科手术的方式对隔离装置进行回收，减少了对患者的损伤。

Description

一种隔离装置的回收系统及预装载、后装载的介入系统 技术领域
本发明涉及医疗器械领域，具体地说，特别涉及到一种实施心脏隔离装置介入手术的器械，尤其涉及一种隔离装置的回收系统；还涉及一种隔离装置预装载的介入系统及后装载的介入系统。
背景技术
近年来心脏病的治疗有了长足的发展，但是作为所有心脏病最终结局之一的心力衰竭却始终威胁着人类健康。导致心力衰竭的原因众多，最常见的病因之一为急性心肌梗死。急性心肌梗死由于心肌损伤以及随后的瘢痕化，导致心脏扩大以及心力衰竭的发生，尤其是前壁心肌梗死合并室壁瘤的患者更容易发生心力衰竭，不仅影响患者的生活质量，还造成巨大的家庭和社会的经济负担。
为了治疗心脏病，特别是充血性心力衰竭，一种潜在的治疗方法是在病人左心室植入一种伞状的隔离装置，CN103800045A提供了一种医疗用心脏隔离装置，其包括支撑架和底座，所述支撑架由多个可显影装置、多个固定尖、多个伞骨状节杆和多个弧面构成，其中每相邻两个伞骨状节杆通过弧面连接构成倒置伞状形的支撑架且支撑架的伞沿周围向外翻，伞骨状节杆的一端连接相应的固定尖且固定尖搭在支撑架的伞沿上，每个固定尖上装有可显影装置，每个伞骨状节杆和固定尖上均覆有高分子隔离膜，支撑架的底部与底座连接，底座的底部呈一平面。
该隔离装置可以通过经皮介入方式用鞘管和输送系统将其输送进人体心脏内，改善心室重构和患者的心功能。但是在手术时，当发生植入位置不合适、产品尺寸太小无法满足病变需求或者其它的原因时，就需要通过外科手术的方式将隔离装置取出，这给患者带来了较大的创伤。
发明内容
为了解决现有技术中存在的问题，本发明提供了一种隔离装置的回收系统及预装载、后装载的介入系统，可通过经导管的方式对释放不成功的隔离装置进行收束、回收。
根据本发明的一个方面，提供了一种用于隔离装置的回收系统，所述隔离装置包括用于收束的缝合线以及连接的线头，所述回收系统包括：用于在鞘管内进行输送的回收装置以及抓捕装置，其中：
所述回收装置包括在鞘管内输送的回收导管，以及位于回收导管内的用于顶住所述隔离装置的顶杆；
所述抓捕装置被配置为：当隔离装置释放不成功，则通过抓捕装置以及回收装置对隔离装置的缝合线进行抓取、收束。
可选地，所述回收装置中，在所述回收导管的远端设置有弹性的扩口结构，所述扩口结构被配置为：当扩口结构伸出鞘管时释放所述扩口结构；当扩口结构位于鞘管内时，所述扩口结构被压缩在所述鞘管内。
可选地，在所述回收导管的侧壁还设置有快速交换口；所述快速交换口沿着回收导管的轴向延伸。
可选地，所述抓捕装置包括具有近端和远端的外管，在所述外管的管壁上设置有缺口；还包括从外管近端伸入的锁紧推杆，所述锁紧推杆被配置为伸入至外管内超过缺口的位置；所述锁紧推杆与外管在所述缺口位置的间隙被配置为阻止缝合线的线头通过。
可选地，所述抓捕装置包括具有近端和远端的外管；还包括封堵部，所述封堵部部分封堵所述外管的远端，并在远端形成缺口；
还包括径向转动连接在外管内的锁紧杆，在所述锁紧杆的侧壁设置有沿其轴向延伸的凹槽，所述锁紧杆与外管的配合关系如下：所述锁紧杆具有一转动至使凹槽露出在缺口位置的自由状态；以及将凹槽转动至封堵部位置的锁紧状态，在锁紧状态，所述锁紧杆的远端与封堵部之间的间隙被配置为阻止缝合线的线头通过。
可选地，所述抓捕装置包括具有近端和远端的外管，所述外管的远端具有刃面，还包括穿过所述外管的用于预先连接缝合线的收紧线；还包括 从外管近端伸入的推杆，所述推杆伸出外管远端的位置设置有用于与所述刃面配合的堵头。
可选地，所述外管整体采用金属材料，所述外管远端的外壁呈锥面，以形成所述刃面。
可选地，所述外管包括树脂管材，所述刃面形成在与树脂管材连接成一体的金属管口上。
可选地，所述抓捕装置包括基本位于隔离装置的中心位置且具有近端和远端的外管，还包括从外管近端伸入的锁紧导丝，所述锁紧导丝伸出外管远端的位置具有朝向外侧弯曲的弯曲部，在所述锁紧导丝的远端设置有钩体，所述钩体被弯曲部配置至隔离装置的缝合线位置，且所述弯曲部被配置为在回拉锁紧导丝时，所述弯曲部变形至与外管的形状匹配。
可选地，所述输送器的端头设置有用于与隔离装置螺纹连接的螺纹连接部。
根据本发明的另一方面，提供了一种隔离装置预装载的介入系统，所述隔离装置包括用于收束的缝合线以及连接的线头，所述介入系统包括植入系统以及回收系统；所述植入系统包括鞘管，以及在鞘管内对隔离装置进行输送的输送器；
所述回收系统包括：用于在鞘管内输送的回收装置以及抓捕装置，其中：
所述回收装置包括在鞘管内输送的回收导管，以及位于回收导管内的用于顶住所述隔离装置的顶杆；
所述隔离装置的缝合线预装载在抓捕装置上，且所述抓捕装置被配置为：当输送器释放成功，则抓捕装置卸载所述隔离装置的缝合线；当输送器释放不成功，则回撤所述抓捕装置，并将隔离装置的开口收束。
可选地，所述回收装置中，在所述回收导管的远端设置有弹性的扩口结构，所述扩口结构被配置为：当扩口结构伸出鞘管时释放所述扩口结构；当扩口结构位于鞘管内时，所述扩口结构被压缩在所述鞘管内。
可选地，在所述回收导管的侧壁还设置有快速交换口。
可选地，所述快速交换口沿着回收导管的轴向延伸。
可选地，所述抓捕装置包括具有近端和远端的外管，在所述外管的管壁上设置有缺口；还包括从外管近端伸入的锁紧推杆，所述锁紧推杆被配置为伸入至外管内超过缺口的位置；所述锁紧推杆与外管在所述缺口位置的间隙被配置为阻止缝合线的线头通过。
可选地，所述抓捕装置包括具有近端和远端的外管；还包括封堵部，所述封堵部部分封堵所述外管的远端，并在远端形成缺口；
还包括径向转动连接在外管内的锁紧杆，在所述锁紧杆的侧壁设置有沿其轴向延伸的凹槽，所述锁紧杆与外管的配合关系如下：所述锁紧杆具有一转动至使凹槽露出在缺口位置的自由状态；以及将凹槽转动至封堵部位置的锁紧状态，在锁紧状态，所述锁紧杆的远端与封堵部之间的间隙被配置为阻止缝合线的线头通过。
可选地，所述抓捕装置包括具有近端和远端的外管，所述外管的远端具有刃面，还包括穿过所述外管的用于预先连接缝合线的收紧线；还包括从外管近端伸入的推杆，所述推杆伸出外管远端的位置设置有用于与所述刃面配合的堵头。
可选地，所述外管整体采用金属材料，所述外管远端的外壁呈锥面，以形成所述刃面。
可选地，所述外管包括树脂管材，所述刃面形成在与树脂管材连接成一体的金属管口上。
可选地，所述输送器的端头设置有用于与隔离装置螺纹连接的螺纹连接部。
根据本发明的另一方面，提供了一种隔离装置后装载的介入系统，所述隔离装置包括用于收束的缝合线以及连接的线头，所述介入系统包括植入系统以及回收系统；所述植入系统包括鞘管，以及在鞘管内对隔离装置进行输送的输送器；
所述回收系统包括：用于在鞘管内进行输送的回收装置以及抓捕装置，其中：
所述回收装置包括在鞘管内输送的回收导管，以及位于回收导管内的用于顶住所述隔离装置的顶杆；
所述回收装置、抓捕装置被配置为：当隔离装置释放不成功时，则在鞘管内输送所述抓捕装置、回收装置，以对隔离装置的缝合线进行抓取、收束。
可选地，所述回收装置中，在所述回收导管的远端设置有弹性的扩口结构，所述扩口结构被配置为：当扩口结构伸出鞘管时释放所述扩口结构；当扩口结构位于鞘管内时，所述扩口结构被压缩在所述鞘管内。
可选地，在所述回收导管的侧壁还设置有快速交换口。
可选地，所述快速交换口沿着回收导管的轴向延伸。
可选地，所述抓捕装置包括基本位于隔离装置的中心位置且具有近端和远端的外管，还包括从外管近端伸入的锁紧导丝，所述锁紧导丝伸出外管远端的位置具有朝向外侧弯曲的弯曲部，在所述锁紧导丝的远端设置有钩体，所述钩体被弯曲部配置至隔离装置的缝合线位置，且所述弯曲部被配置为在回拉锁紧导丝时，所述弯曲部变形至与外管的形状匹配。
可选地，所述锁紧导丝上钩体的硬度大于锁紧导丝上其余位置的硬度。
可选地，所述锁紧导丝上的钩体与其余位置采用不同的材料。
可选地，所述顶杆以及抓捕装置在回收导管的同一腔室内输送。
可选地，所述回收导管具有多个沿回收导管轴向延伸的腔室，所述顶杆以及抓捕装置在回收导管不同的腔室内输送。
可选地，所述输送器的端头设置有用于与隔离装置螺纹连接的螺纹连接部。
本发明的一种隔离装置的回收系统及预装载、后装载的介入系统，可通过经导管的方式对释放不成功的隔离装置进行收束、回收，可以避免采用外科手术的方式对隔离装置进行回收，减少了对患者的损伤。
通过以下参照附图对本发明的示例性实施例的详细描述，本发明的其它特征及其优点将会变得清楚。
附图说明
构成说明书的一部分的附图描述了本发明的实施例，并且连同说明书一起用于解释本发明的原理。
图1是现有技术中隔离装置的结构示意图。
图2是本发明回收系统的操作示意图。
图3是本发明回收装置的结构示意图。
图4是本发明第一种实施方式抓捕装置与隔离装置的配合图。
图5是图4中抓捕装置位于缺口位置的局部放大图。
图6是图4中抓捕装置另一种优选实施方式的局部放大图。
图7是本发明第二种实施方式抓捕装置与隔离装置的配合图。
图8是本发明第三种实施方式抓捕装置的结构示意图。
图9是本发明第三种实施方式抓捕装置另一角度的结构示意图。
图10是本发明第四种实施方式抓捕装置的结构示意图。
图11是图10中锁紧导丝的结构示意图。
图12是本发明第五种实施方式抓捕装置的结构示意图。
图13是本发明回收系统在回收隔离装置时的示意图。
图14是本发明介入系统构成的示意图。
具体实施方式
现在将参照附图来详细描述本发明的各种示例性实施例。应注意到：除非另外具体说明，否则在这些实施例中阐述的部件和步骤的相对布置、数字表达式和数值不限制本发明的范围。
以下对至少一个示例性实施例的描述实际上仅仅是说明性的，决不作为对本发明及其应用或使用的任何限制。
对于相关领域普通技术人员已知的技术和设备可能不作详细讨论，但在适当情况下，所述技术和设备应当被视为说明书的一部分。
在这里示出和讨论的所有例子中，任何具体值应被解释为仅仅是示例性的，而不是作为限制。因此，示例性实施例的其它例子可以具有不同的值。
应注意到：相似的标号和字母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讨论。
图1示出了现有技术中隔离装置1的结构示意图，该隔离装置1包括支撑在基座1b上方的伞状结构，该伞状结构包括在圆周上排列的多个支撑杆，该多个支撑杆排布的形状类似伞骨结构。还包括固定在该多个支撑杆上的膜1a，所述膜1a在支撑杆的支撑作用下，形成了一端封闭、一端逐渐张开的伞状结构。在所述膜1a开口端的边缘位置设置有一圈缝合线1c，该缝合线1c的两端连接在一起，形成线头1d。当然，也可以在缝合线1c的端头位置通过打结或者本领域技术人员所熟知的其它方式形成膨大的线头1d。在此需要注意的是，线头1d可以根据需要设置多个。通过缝合线1c可以将膜1a的开口端收束起来。这种隔离装置1的结构及其工作原理均属于本领域技术人员的公知常识，在此不再具体说明。
本发明提供的是一种在心脏相应位置植入上述隔离装置1的介入系统，其包括植入系统以及回收系统。通过植入系统可以将上述隔离装置1植入心室2的相应位置，以使其发挥作用，参考图2；当需要将其从心室2中取出时，则可通过本发明的回收系统进行回收，参考图13。
参考图14，本发明的植入系统可以包括鞘管3以及在鞘管3内对隔离装置1进行输送的输送器7，该输送器7的端头具有一连接部70，通过该连接部70来实现输送器7与隔离装置1的连接。在进行介入操作时，将所述隔离装置1连同输送器7装填在鞘管3内，通过输送器7将隔离装置1输送至预定位置，并使隔离装置1从鞘管3的远端穿出，从而将隔离装置1释放出来；之后将输送器7与隔离装置1脱离，完成隔离装置1的植入。本发明输送器7的连接部70可以是螺纹结构，通过该螺纹结构与隔离装置1实现螺纹连接，从而便于输送器7与隔离装置1的脱离。
本发明的回收系统，包括鞘管3以及位于鞘管3内的回收装置4、抓捕装置6，所述回收装置4、抓捕装置6均可在鞘管3内进行操作，以完成对隔离装置1的回收。其中，在所述鞘管3内可以设置多个沿鞘管3轴向方向延伸的腔室，所述回收装置4与抓捕装置6可以设置在鞘管3的同一腔室内，也可以设置在鞘管3的不同腔室内。
图3示出了本发明回收装置4的结构示意图，其包括在鞘管3内进行输送的回收导管40，以及位于回收导管40内的顶杆43。顶杆43的作用是 在通过抓捕装置6抓取隔离装置1的缝合线1c时，将顶杆43顶在隔离装置1的中心位置，以便于抓捕装置6抓取隔离装置1的缝合线1c进行收束。在此需要注意的是，本发明的顶杆43也可以采用输送器7本身替代，也就是说，通过上述的输送器7与抓捕装置6的配合，也可以实现隔离装置1的收束。
本发明的顶杆43与抓捕装置6优选分别采用多个具有不同硬度的分段连接而成，例如顶杆43、抓捕装置6的中段可以采用较软的材料或结构，从而可以便于该段的弯曲，以穿过鞘管3。例如它们的中段可以采用容易弯曲的螺旋管结构等。顶杆43、抓捕装置6两端的位置可以采用较硬的材料，以满足操作的需求。另外，所述顶杆43的远端优选具有球头结构，通过所述球头结构可以使顶杆43的远端可以顺利地与隔离装置的中心位置配合在一起。
所述回收导管40可以从鞘管3的近端伸入，并从鞘管3的远端部分地穿出。其中，在所述回收导管40的远端设置有弹性的扩口结构41，且所述扩口结构41被配置为：当扩口结构41伸出鞘管3时释放所述扩口结构41；当扩口结构41位于鞘管3内时，所述扩口结构41被压缩在所述鞘管3内。
本发明的扩口结构41在释放状态时呈喇叭状，该扩口结构41可以采用弹性的材质，使其具有一定的弹性变形能力。
在本发明一个具体的实施方式中，所述扩口结构41可以采用本领域技术人员所熟知的自弹性的高分子材料，例如可以采用薄膜型高分子材料，其可以通过一次成型或者剪切成型的方式制得。
在本发明另一个具体的实施方式中，所述扩口结构41可以采用金属网材质，其可通过编织成型或者激光切割的方式成型。
本发明的回收导管40可以采用与扩口结构41相同的材质，也可以采用不同的材质，由于回收导管40主要起输送、连接的作用，因此其可以采用普通的金属材质或者高分子材质等。在装填的时候，将回收导管40以及扩口结构41一同装入鞘管3内，此时所述扩口结构41被压缩，使得其可以与回收导管40一起在鞘管3内进行输送；当扩口结构41从鞘管3的远 端穿出后，由于失去了鞘管3的限制，使得扩口结构41可以在其自身恢复力的作用下被释放出来，从而便于接收隔离装置1。当隔离装置1被收入回收导管40或扩口结构41内时，可以将回收导管40从鞘管3内抽出，以完成隔离装置1的回收。
本发明的顶杆43可从回收导管40内穿入，其主要用于与抓捕装置6配合，以完成对隔离装置1的收束。本发明的回收装置，优选的是，在所述回收导管40的侧壁还设置有快速交换口42。该快速交换口42可以呈圆形或者方形，优选其沿着回收导管40的轴向延伸，参考图3。将快速交换口42设置在回收导管40的侧壁，使得所需的各部件可以经过该快速交换口42穿过回收导管40的扩口结构41，以方便相关器械的操作。其中，回收导管的侧壁也可以不设置快速交换口，相关各部件直接通过回收导管的同一腔室或不同腔室。
其中，本发明的抓捕装置6也可以在回收导管40内输送，其与顶杆43可以在回收导管40的同一腔室内进行输送。所述回收导管40优选具有多个沿回收导管40轴向分布的腔室，所述顶杆43和抓捕装置6位于不同的腔室内。
图4至图12示出了本发明抓捕装置6五种不同的实施结构示意图。
参考图4、图5，在本发明第一个具体的实施方式中，所述抓捕装置6包括外管610，该外管610可以作为抓捕装置6的主体部分在鞘管3或者回收导管40内输送。所述外管610具有一近端以及一远端。在所述外管610的管壁上设置有缺口612，该缺口612的形状可以呈长方形、圆形或者本领域技术人员所熟知的其它形状。
本发明的抓捕装置6还包括从外管610近端伸入的锁紧推杆611，且所述锁紧推杆611被配置为伸入至外管610内超过缺口612的位置；所述锁紧推杆611与外管610在所述缺口612位置的间隙被配置为阻止缝合线1c的线头1d通过。
本发明的外管610可以采用金属材料，所述锁紧推杆611可以采用丝状或者片材状，其可以采用金属的材质。锁紧推杆611从外管610的近端引入，并沿着外管610的延伸方向伸入至越过所述缺口612的位置，使得 所述缝合线1c可以卡在锁紧推杆611与外管610在缺口612位置的内壁之间。由于线头1d的尺寸远大于缝合线1c的尺寸，在拉扯缝合线1c的过程中，线头1d始终不会从锁紧推杆611与外管610之间穿过。
本发明的缺口612优选设置在邻近所述外管610远端的位置，以便于对隔离装置1的抓取。
初始状态时，拉出所述锁紧推杆611以将外管610的缺口612暴露出来，将邻近线头1d位置的缝合线1c放置在缺口612上，并使缝合线1c尽量贴覆在外管610在缺口612位置的内壁上；此时推入锁紧推杆611并使其远端越过外管610的缺口612位置，这就将缝合线1c挤压在锁紧推杆611与外壳610之间，从而实现了缝合线1c的与抓捕装置6的装载。
在回收隔离装置1的时候，将回收装置4的顶杆43顶在隔离装置1的中心位置，向外抽取所述外管610以及缝合线1c，从而将隔离装置1的开口收束起来，参考图13；最后配合顶杆43以及外管610的控制，将收束后的隔离装置1移动至回收导管40或者扩口结构41中，通过回撤所述回收导管40将隔离装置1取出。
本发明的抓捕装置，所述外管610的远端可以是封闭的，也可以是非封闭的。当外管610的远端采用封闭的结构时，其远端优选呈弧面或者球面，使得可以避免外管610远端对人体造成损害。进一步优选的是，所述外管610的远端采用弹性高分子材料。优选的是，外管610的远端与外管610其余位置的部分可以采用不同的材料，并可通过后续的装配将二者连接在一起。
本发明的抓捕装置6在卸载隔离装置1的时候，只需要将锁紧推杆611回撤，将外管610的缺口612露出，即可将缝合线1c释放出来。
参考图6，本发明外管610上的缺口612也可以设置有两个，分别通过两个缺口612位置对缝合线1c上的两个线头进行装载，可进一步保证缝合线1c与抓捕装置装载的可靠性。
图7示出了本发明抓捕装置第二个具体实施方式的结构示意图，所述抓捕装置包括外管620，该外管620可以作为抓捕装置的主体部分在鞘管3或者回收导管40内输送。所述外管620具有一近端以及一远端。其中，所 述外管620的远端具有刃面622，该刃面622可以分布在外管620远端的圆周方向上。
本发明的外管620整体可以采用金属材料，所述外管620远端的外壁呈锥面，以形成所述刃面622。所述外管620也可以选用非金属材料，例如，所述外管620可以包括树脂管材，所述刃面622形成在与树脂管材连接成一体的金属管口上。也就是说，所述外管620由树脂管材和金属管口连接而成，所述刃面622可以设置在金属管口位置。
本发明的抓捕装置，还包括穿过所述外管620的收紧线624，该收紧线624可以采用PP、PET材料或者本领域技术人员所熟知的其它材料。其从外管620的近端伸入，并从外管620的远端穿出。在装载的时候，可将收紧线624扣在隔离装置1的缝合线1c上，从而实现抓捕装置6与隔离装置1的装载。
本发明的抓捕装置，还包括从外管620近端伸入的推杆621，该推杆621可以采用金属材料制成，其可以采用丝状或者片材状。所述推杆621的远端从外管620的远端伸出，并在该伸出位置连接有用于与所述刃面622配合的堵头623。所述堵头623的尺寸远大于推杆621的尺寸，其可以呈圆柱状、圆台状或者本领域技术人员所熟知的其它形状。
由于该抓捕装置中的收紧线624连接在隔离装置1的缝合线1c上，当判断隔离装置释放成功后，可通过拉取推杆621，使得推杆621远端的堵头623与刃面622接触配合在一起，从而将收紧线624切断，以完成隔离装置1与抓捕装置的卸载。当判断隔离装置释放失败后，可拉取收紧线624以及与收紧线624连接的缝合线1c，并配合回收装置的顶杆43将隔离装置1的开口收束起来；最后配合顶杆43以及外管620、收紧线624的控制，将收束后的隔离装置1移动至回收导管40或者扩口结构41中，通过回撤回收导管40将隔离装置1取出。
图8、图9示出了本发明抓捕装置第三种实施方式的结构示意图，所述抓捕装置包括外管630，该外管630可以作为抓捕装置的主体部分在鞘管3或者回收导管40内输送。所述外管630具有一近端以及一远端。还包括设置在外管630远端的封堵部633，所述封堵部633部分封堵所述外管 630的远端，所述外管630远端没有被封堵的位置则形成一缺口634。
本发明的外管可以采用金属材料，也可以采用非金属材料，例如可以采用高分子材质。所述封堵部633与外管630可以采用一体成型的方式得到。
本发明的抓捕装置，还包括径向转动连接在外管630内的锁紧杆631，所述锁紧杆631在外管630可以发生径向的转动。为了避免锁紧杆631发生轴向的位移，可在外管630内设置阻挡部或者轴承结构等，这种结构属于本领域技术人员的公知常识，在此不再具体说明。
本发明的锁紧杆631可以采用金属材质，也可以采用高分子材质。在所述锁紧杆631的侧壁设置有凹槽632，参考图9，所述凹槽632沿着锁紧杆631的轴向延伸。其中，所述锁紧杆631与外管630的配合关系如下：所述锁紧杆631具有一转动至使凹槽632露出在缺口634位置的自由状态；以及将凹槽632转动至封堵部633位置的锁紧状态，在锁紧状态，所述锁紧杆631的远端与封堵部633之间的间隙被配置为阻止缝合线1c的线头1d通过。
具体地，在径向转动锁紧杆631时，可以将锁紧杆631的凹槽632转动至暴露在缺口634的位置，如图9示出的状态。此时可以将隔离装置1的缝合线1c以及线头1d通过所述缺口634塞入锁紧杆631的凹槽632中；转动锁紧杆631，并将其上的凹槽632转动至与封堵部633对应的位置，此时，所述缝合线1c被卡在锁紧杆631远端与封堵部633之间的间隙中，从而实现了缝合线1c的与抓捕装置的装载。在通过外管630拉取缝合线1c时，由于线头1d被卡在锁紧杆631的凹槽中，从而可以防止缝合线1c的窜动，保证了隔离装置1与抓捕装置的稳固装载。
在进行卸载的时候，只需要转动锁紧杆631，将其上的凹槽632重新暴露在缺口634的位置，即可释放所述缝合线1c，完成抓捕装置与隔离装置1的卸载。
本发明凹槽632的形状可以是矩形、半圆形或者本领域技术人员所熟知的其它形状。所述锁紧杆631可以采用半圆环的扁管结构，也就是说，将一圆管沿着其轴向的方向进行切割，从而形成截面呈半圆环状的扁管结 构。优选的是，所述封堵部633的面积可以大于或等于缺口634的面积，以便于装载隔离装置1的缝合线1c。
图10、图11示出了本发明抓捕装置第四种实施方式的结构示意图，其包括基本位于隔离装置1中心位置的外管640，该外管640可以作为抓捕装置的主体部分在鞘管3或者回收导管40内输送。所述外管640具有一近端以及一远端。
还包括从外管640近端伸入的锁紧导丝641，所述锁紧导丝641从外管640的近端伸入，并从其远端伸出。所述锁紧导丝641伸出外管640远端的位置具有朝向外侧弯曲的弯曲部643，在所述锁紧导丝641的远端设置有钩体642。其中，所述钩体642被弯曲部643配置至隔离装置1的缝合线1c位置，且所述弯曲部643被配置为在回拉锁紧导丝641时，所述弯曲部643变形至与外管640的形状匹配。
本发明的外管640从鞘管3或者回收导管40伸出，为了后续便于将隔离装置1回收至回收导管40中，所述外管640伸出后，其基本位于隔离装置1的中心位置。由于介入时的空间过小，因此，为了将钩体642延伸至隔离装置1的缝合线1c位置，设置了所述弯曲部643，通过该弯曲部643的弯曲变形，从而使钩体642与缝合线1c尽量靠近在一起，以便于通过钩体642抓取缝合线1c。
本发明的抓捕装置，首先需要将锁紧导丝641装填在外管640内，此时可以挤压其弯曲部643发生变形，使其钩体642靠近锁紧导丝641的本体，并将其装填在外管640内；当弯曲部643从外管640的远端穿出后，在其自身的弹性恢复力下，所述弯曲部643复位，从而使钩体642配合在隔离装置1的缝合线1c位置。通过细微的操作即可通过钩体642将缝合线1c抓取住。
当钩体642抓取缝合线1c后，在回拉锁紧导丝641时，所述弯曲部643需要发生变形至与外管640的形状匹配，使得可以将钩体642往外管640内回撤，从而将隔离装置1的开口收束起来。
本发明的所述外管640可以采用金属材料或高分子材料。所述锁紧导丝641也可以采用金属材料或高分子材料。在回拉缝合线1c的时候，由于 缝合线1c会对钩体642产生反向的拉力，为了避免钩体642发生变形，所述锁紧导丝641上钩体642的硬度大于锁紧导丝641上其余位置的硬度。所述锁紧导丝641上的钩体642与其余位置可以采用不同的材料，或者经过不同的工艺处理，以保证钩体642的硬度。
图12示出了本发明抓捕装置第五种实施方式的结构示意图，该抓捕装置采用了一根较长的收紧线650，将该收紧线650的一端穿过隔离装置的缝合线1c，再折回。当隔离装置释放成功时，则松开收紧线650的一端，并将收紧线650抽出；当隔离装置释放不成功时，则同时抽取收紧线650的两端，将隔离装置收束起来。
本发明还提供了一种预装载方式的隔离装置的介入方法，其包括以下步骤：
a)将隔离装置装载在输送器上，并将隔离装置的缝合线预装载在抓捕装置上；
d)将输送器、隔离装置、抓捕装置一同沿鞘管送至心室的合适位置；
c)释放所述隔离装置，并判断隔离装置是否释放成功；
如果隔离装置释放成功，则执行
d10)卸载缝合线，并使输送器与隔离装置脱离，输送器与抓捕装置一同从鞘管撤回；
如果隔离装置释放不成功，则执行
d20)将输送器与隔离装置分离，并撤回所述输送器；
d21)将回收装置沿鞘管送入，待扩口结构释放后，推进顶杆顶住隔离装置的中部；
d22)回拉抓捕装置，使隔离装置的开口收束，并将隔离装置拉入回收装置的扩口结构内；
d23)回撤整个抓捕装置以及回收装置，完成隔离装置的回收。
上述方法是以预先装载隔离装置缝合线的方式进行植入或回收的，当植入成功后，则卸载抓捕装置与缝合线的连接，图4至图9、图12示出的抓捕装置均需要以预装载的方式进行回收。
本发明还提供了一种后装载方式的隔离装置的介入方法，其包括以下 步骤：
a)将隔离装置装载在输送器上，将输送器、隔离装置一同沿鞘管送至心室的合适位置；
d)释放所述抓捕装置，并判断隔离装置是否释放成功；
如果隔离装置释放成功，则执行
d10)将输送器与隔离装置脱离，并使输送器从鞘管撤回；
如果隔离装置释放不成功，则执行
d20)将输送器与隔离装置分离，并撤回所述输送器；
d21)将回收装置以及抓捕装置沿鞘管送入，待扩口结构释放后，通过抓捕装置抓取隔离装置的缝合线；
d22)推进顶杆顶住隔离装置的中部，回拉抓捕装置，使隔离装置的开口收束，并将隔离装置拉入回收装置的扩口结构内；
d23)回撤整个抓捕装置以及回收装置，完成隔离装置的回收。
该方法是以后装载的方式进行回收，也就是说，当判断隔离装置释放不成功时，将回收装置以及抓捕装置沿鞘管送入，并可利用抓捕装置来完成隔离装置缝合线的抓取。图10、图11示出的抓捕装置适合这种后装载方式的回收。
上述两个方法的区别在于，一种是采用抓捕装置与隔离装置在体外的预装载方式，一种采用抓捕装置与隔离装置在体内的后装载方式。因此，本发明提供的介入系统也可以被区分为隔离装置预装载的介入系统以及隔离装置后装载的介入系统。
本发明的介入系统，当隔离装置释放不成功时，可以通过回收装置以及抓捕装置对隔离装置进行回收，采用这种经导管的回收方式，可以避免外科手术进行回收所带来的损伤。
虽然已经通过示例对本发明的一些特定实施例进行了详细说明，但是本领域的技术人员应该理解，以上示例仅是为了进行说明，而不是为了限制本发明的范围。本领域的技术人员应该理解，可在不脱离本发明的范围和精神的情况下，对以上实施例进行修改。本发明的范围由所附权利要求来限定。

Claims (30)

  1. 一种用于隔离装置的回收系统，所述隔离装置包括用于收束的缝合线以及连接的线头，其特征在于：所述回收系统包括：用于在鞘管内进行输送的回收装置以及抓捕装置，其中：
    所述回收装置包括在鞘管内输送的回收导管，以及位于回收导管内的用于顶住所述隔离装置的顶杆；
    所述抓捕装置被配置为：当隔离装置释放不成功，则通过抓捕装置以及回收装置对隔离装置的缝合线进行抓取、收束。
  2. 根据权利要求1所述的回收系统，其特征在于：所述回收装置中，在所述回收导管的远端设置有弹性的扩口结构，所述扩口结构被配置为：当扩口结构伸出鞘管时释放所述扩口结构；当扩口结构位于鞘管内时，所述扩口结构被压缩在所述鞘管内。
  3. 根据权利要求1所述的回收系统，其特征在于：在所述回收导管的侧壁还设置有快速交换口；所述快速交换口沿着回收导管的轴向延伸。
  4. 根据权利要求1所述的回收系统，其特征在于：所述抓捕装置包括具有近端和远端的外管，在所述外管的管壁上设置有缺口；还包括从外管近端伸入的锁紧推杆，所述锁紧推杆被配置为伸入至外管内超过缺口的位置；所述锁紧推杆与外管在所述缺口位置的间隙被配置为阻止缝合线的线头通过。
  5. 根据权利要求1所述回收系统，其特征在于：所述抓捕装置包括具有近端和远端的外管；还包括封堵部，所述封堵部部分封堵所述外管的远端，并在远端形成缺口；
    还包括径向转动连接在外管内的锁紧杆，在所述锁紧杆的侧壁设置有沿其轴向延伸的凹槽，所述锁紧杆与外管的配合关系如下：所述锁紧杆具有一转动至使凹槽露出在缺口位置的自由状态；以及将凹槽转动至封堵部位置的锁紧状态，在锁紧状态，所述锁紧杆的远端与封堵部之间的间隙被配置为阻止缝合线的线头通过。
  6. 根据权利要求1所述的回收系统，其特征在于：所述抓捕装置包括具有近端和远端的外管，所述外管的远端具有刃面，还包括穿过所述外管的用于预先连接缝合线的收紧线；还包括从外管近端伸入的推杆，所述推杆伸出外管远端的位置设置有用于与所述刃面配合的堵头。
  7. 根据权利要求6所述的回收系统，其特征在于：所述外管整体采用金属材料，所述外管远端的外壁呈锥面，以形成所述刃面。
  8. 根据权利要求6所述的回收系统，其特征在于：所述外管包括树脂管材，所述刃面形成在与树脂管材连接成一体的金属管口上。
  9. 根据权利要求1所述的介入系统，其特征在于：所述抓捕装置包括基本位于隔离装置的中心位置且具有近端和远端的外管，还包括从外管近端伸入的锁紧导丝，所述锁紧导丝伸出外管远端的位置具有朝向外侧弯曲的弯曲部，在所述锁紧导丝的远端设置有钩体，所述钩体被弯曲部配置至隔离装置的缝合线位置，且所述弯曲部被配置为在回拉锁紧导丝时，所述弯曲部变形至与外管的形状匹配。
  10. 根据权利要求1所述的回收系统，其特征在于：所述输送器的端头设置有用于与隔离装置螺纹连接的螺纹连接部。
  11. 一种隔离装置预装载的介入系统，所述隔离装置包括用于收束的缝合线以及连接的线头，其特征在于：所述介入系统包括植入系统以及回收系统；所述植入系统包括鞘管，以及在鞘管内对隔离装置进行输送的输送器；
    所述回收系统包括：用于在鞘管内输送的回收装置以及抓捕装置，其中：
    所述回收装置包括在鞘管内输送的回收导管，以及位于回收导管内的用于顶住所述隔离装置的顶杆；
    所述隔离装置的缝合线预装载在抓捕装置上，且所述抓捕装置被配置为：当输送器释放成功，则抓捕装置卸载所述隔离装置的缝合线；当输送器释放不成功，则回撤所述抓捕装置，并将隔离装置的开口收束。
  12. 根据权利要求11所述的介入系统，其特征在于：所述回收装置中，在所述回收导管的远端设置有弹性的扩口结构，所述扩口结构被配置 为：当扩口结构伸出鞘管时释放所述扩口结构；当扩口结构位于鞘管内时，所述扩口结构被压缩在所述鞘管内。
  13. 根据权利要求11所述的介入系统，其特征在于：在所述回收导管的侧壁还设置有快速交换口。
  14. 根据权利要求13所述的介入系统，其特征在于：所述快速交换口沿着回收导管的轴向延伸。
  15. 根据权利要求11所述的介入系统，其特征在于：所述抓捕装置包括具有近端和远端的外管，在所述外管的管壁上设置有缺口；还包括从外管近端伸入的锁紧推杆，所述锁紧推杆被配置为伸入至外管内超过缺口的位置；所述锁紧推杆与外管在所述缺口位置的间隙被配置为阻止缝合线的线头通过。
  16. 根据权利要求11所述的介入系统，其特征在于：所述抓捕装置包括具有近端和远端的外管；还包括封堵部，所述封堵部部分封堵所述外管的远端，并在远端形成缺口；
    还包括径向转动连接在外管内的锁紧杆，在所述锁紧杆的侧壁设置有沿其轴向延伸的凹槽，所述锁紧杆与外管的配合关系如下：所述锁紧杆具有一转动至使凹槽露出在缺口位置的自由状态；以及将凹槽转动至封堵部位置的锁紧状态，在锁紧状态，所述锁紧杆的远端与封堵部之间的间隙被配置为阻止缝合线的线头通过。
  17. 根据权利要求11所述的介入系统，其特征在于：所述抓捕装置包括具有近端和远端的外管，所述外管的远端具有刃面，还包括穿过所述外管的用于预先连接缝合线的收紧线；还包括从外管近端伸入的推杆，所述推杆伸出外管远端的位置设置有用于与所述刃面配合的堵头。
  18. 根据权利要求17所述的介入系统，其特征在于：所述外管整体采用金属材料，所述外管远端的外壁呈锥面，以形成所述刃面。
  19. 根据权利要求17所述的介入系统，其特征在于：所述外管包括树脂管材，所述刃面形成在与树脂管材连接成一体的金属管口上。
  20. 根据权利要求11所述的介入系统，其特征在于：所述输送器的端头设置有用于与隔离装置螺纹连接的螺纹连接部。
  21. 一种隔离装置后装载的介入系统，所述隔离装置包括用于收束的缝合线以及连接的线头，其特征在于：所述介入系统包括植入系统以及回收系统；所述植入系统包括鞘管，以及在鞘管内对隔离装置进行输送的输送器；
    所述回收系统包括：用于在鞘管内进行输送的回收装置以及抓捕装置，其中：
    所述回收装置包括在鞘管内输送的回收导管，以及位于回收导管内的用于顶住所述隔离装置的顶杆；
    所述回收装置、抓捕装置被配置为：当隔离装置释放不成功时，则在鞘管内输送所述抓捕装置、回收装置，以对隔离装置的缝合线进行抓取、收束。
  22. 根据权利要求21所述的介入系统，其特征在于：所述回收装置中，在所述回收导管的远端设置有弹性的扩口结构，所述扩口结构被配置为：当扩口结构伸出鞘管时释放所述扩口结构；当扩口结构位于鞘管内时，所述扩口结构被压缩在所述鞘管内。
  23. 根据权利要求22所述的介入系统，其特征在于：在所述回收导管的侧壁还设置有快速交换口。
  24. 根据权利要求23所述的介入系统，其特征在于：所述快速交换口沿着回收导管的轴向延伸。
  25. 根据权利要求21所述的介入系统，其特征在于：所述抓捕装置包括基本位于隔离装置的中心位置且具有近端和远端的外管，还包括从外管近端伸入的锁紧导丝，所述锁紧导丝伸出外管远端的位置具有朝向外侧弯曲的弯曲部，在所述锁紧导丝的远端设置有钩体，所述钩体被弯曲部配置至隔离装置的缝合线位置，且所述弯曲部被配置为在回拉锁紧导丝时，所述弯曲部变形至与外管的形状匹配。
  26. 根据权利要求25所述的介入系统，其特征在于：所述锁紧导丝上钩体的硬度大于锁紧导丝上其余位置的硬度。
  27. 根据权利要求25所述的介入系统，其特征在于：所述锁紧导丝上的钩体与其余位置采用不同的材料。
  28. 根据权利要求21所述的介入系统，其特征在于：所述顶杆以及抓捕装置在回收导管的同一腔室内输送。
  29. 根据权利要求21所述的介入系统，其特征在于：所述回收导管具有多个沿回收导管轴向延伸的腔室，所述顶杆以及抓捕装置在回收导管不同的腔室内输送。
  30. 根据权利要求21所述的介入系统，其特征在于：所述输送器的端头设置有用于与隔离装置螺纹连接的螺纹连接部。
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