WO2020094085A1 - 改进消融效果的房间隔造口装置及房间隔造口系统 - Google Patents

改进消融效果的房间隔造口装置及房间隔造口系统 Download PDF

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Publication number
WO2020094085A1
WO2020094085A1 PCT/CN2019/116184 CN2019116184W WO2020094085A1 WO 2020094085 A1 WO2020094085 A1 WO 2020094085A1 CN 2019116184 W CN2019116184 W CN 2019116184W WO 2020094085 A1 WO2020094085 A1 WO 2020094085A1
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Prior art keywords
positioning
interatrial
ablation member
ablation
atrial
Prior art date
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PCT/CN2019/116184
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English (en)
French (fr)
Inventor
王永胜
董元博
王坤
Original Assignee
杭州诺生医疗科技有限公司
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Priority claimed from CN201821850409.2U external-priority patent/CN209611296U/zh
Priority claimed from CN201811336604.8A external-priority patent/CN111166462A/zh
Application filed by 杭州诺生医疗科技有限公司 filed Critical 杭州诺生医疗科技有限公司
Publication of WO2020094085A1 publication Critical patent/WO2020094085A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes

Definitions

  • the present application relates to the technical field of interventional medical devices, and in particular to an atrial septostomy device for improving the ablation effect of percutaneous intervention and an atrial septostomy system provided with the atrial septostomy device.
  • Heart failure (abbreviated as heart failure) is a complex set of clinical syndromes that lead to impaired ventricular filling or impaired ejection capacity due to any abnormal structure or function of the heart. Its main clinical manifestations are dyspnea and fatigue (limited activity tolerance), and Fluid retention (pulmonary congestion and peripheral edema). Heart failure is a serious and end stage of various heart diseases, with a high incidence, and is one of the most important cardiovascular diseases today. According to the location of heart failure, it can be divided into left heart, right heart and whole heart failure.
  • Heart failure is a serious disease with a high incidence and mortality.
  • the incidence of heart failure in China is 2-3%, and the number of patients with heart failure is more than 12 million.
  • the main causes of heart failure are hypertension, coronary heart disease, myocardial infarction, heart valve disease, atrial fibrillation, cardiomyopathy and so on.
  • Cardiovascular diseases cause damage to the left ventricle, leading to pathological remodeling of the left ventricle, resulting in hypofunction.
  • Each successful treatment of a patient with a myocardial infarction brings a potential heart failure patient.
  • Cardiac resynchronization therapy is not suitable for all heart failure patients, and more than 20% of patients are not effective for cardiac resynchronization pacing.
  • the operation of left ventricular assist device requires extracorporeal circulation and high trauma complication rate, which is expensive and difficult to obtain.
  • Heart transplantation is the ultimate solution, but the source of donors is very limited and expensive.
  • pulmonary hypertension is a group of diseases characterized by a progressive increase in circulatory resistance of the pulmonary artery system.
  • Pathological changes include pulmonary vasoconstriction and remodeling, abnormal proliferation of pulmonary vascular smooth muscle and endothelial cells, in situ thrombosis, etc. Causes right heart failure and death.
  • the treatment plan for pulmonary hypertension should be individualized and systematic, and can not be treated by a single drug.
  • the treatment methods include: general therapy, non-specific drug therapy, targeted drug therapy, NO inhalation therapy, gene therapy, intervention With surgical treatment.
  • Atrial septostomy is a stoma at the patient's interatrial septum to form a shunt in the left and right heart chambers. It can be used to treat pulmonary hypertension (right-to-left shunt) or left heart failure (left-to-right shunt). Effectiveness.
  • Atrial septostomy methods such as balloon atrial septostomy
  • a ostomy stent which can be published separately for an atrial shunt implant, which is characterized by percutaneous atrial septal puncture, after Percutaneous delivery of an implant implants a shunting device at the puncture of the interatrial septum to keep the shunt opening unobstructed.
  • Another ostomy instrument includes a cutting device and a grasping device.
  • the grasping device first positions and grasps a part of the tissue to be cut; then the grasping part of the cutting device grasps A part of the tissue grabbed by the taking device is cut, and the cut part of the tissue is taken out of the body by the grabbing device, thereby forming a stoma.
  • the implant used for atrial shunt leaving the instrument at the stoma, is likely to cause thrombosis, or the instrument is detached, forming an embolism.
  • the endothelium crawling can cause the opening of the device to be blocked, the channel is closed and the shunt effect is lost.
  • there is a high risk of cutting the intracardiac tissue by mechanical or high-frequency electrocautery during the operation such as loosening during the operation of the intraoperative grasping device or recovery, it may cause the cut tissue to fall off and Embolism is formed.
  • the grasping device is loosened during the cutting process, other myocardial tissues are easily damaged.
  • the purpose of the present application is to provide an atrial septal ostomy device which is not easy to block the stoma and improve the ablation effect, and an interatrial septal ostomy system provided with the atrial septal ostomy device.
  • an atrial septal stoma device with improved ablation effect which includes a support frame for propelling perforations in the interatrial septum.
  • the support frame is provided with at least one ablation member.
  • the ablation member contacts the interatrial septum and is used to ablate the atrial septum.
  • the device cannot ablate blood or tissue except the ablation member.
  • the present application also provides an atrial septostomy system, which includes an atrial septostomy device, a ostomy device control mechanism that controls the atrial septostomy device, and a radio frequency power supply.
  • the ablation member of the atrial septal ostomy device is electrically connected.
  • the atrial septal ostomy device includes a support frame for propelling a perforation in the atrial septum.
  • the support frame is provided with at least one ablation device, and the ablation device contacts
  • the interatrial septum is used to ablate the atrial septum, and the device cannot ablate blood or tissue except the ablation member.
  • the interatrial ostomy device of the interatrial ostomy system includes a support skeleton for propelling the perforation in the interatrial septum, and an ablation member provided on the support skeleton, the ablation member is used for the vicinity of the stoma Atrial septal tissue is ablated, and blood or tissue cannot be ablated on the device except the ablation member.
  • the supporting framework can expand the perforations in the interatrial septum to form a stoma, and ablate the atrial septal tissue around the stoma through the ablation member, and the stoma treated by the atrial septal stoma device
  • the shape is relatively regular, and it is not easy to block, and it can keep the stoma open, so that the blood flow in the left and right heart rooms is smooth.
  • FIG. 1 is a schematic structural diagram of a first implementation manner of an interatrial ostomy system provided by the first example of the present application;
  • FIG. 2 is an enlarged view of the interatrial ostomy device of the interatrial ostomy system in FIG. 1;
  • FIG. 3 is an expanded schematic view of the wire assembly of the interatrial septal ostomy device in FIG. 2;
  • FIG. 4 is a schematic cross-sectional structural view of one of the wires of the wire assembly in FIG. 3;
  • FIG. 5 is an enlarged schematic view of part V in FIG. 1.
  • FIG. 6 is a cross-sectional view taken along line VI-VI in FIG. 5;
  • FIG. 7 is a cross-sectional view taken along line VII-VII in FIG. 5;
  • FIGS. 8 to 11 are schematic diagrams of the operation process of the interatrial ostomy system provided by the first embodiment of the present application.
  • FIG. 12 is a schematic structural diagram of an ablation and sealing device for an interatrial septal ostomy system according to a second embodiment of the present application.
  • FIG. 13 is a front partial cross-sectional view of the ablation plugging device in FIG. 12;
  • FIG. 14 is a schematic structural diagram of an ablation and sealing device of an interatrial septal ostomy system according to a third embodiment of the present application.
  • 15 is a schematic structural diagram of an ablation sealing device of an interatrial septal ostomy system provided in a fourth embodiment of the present application.
  • 16 is a schematic structural diagram of an ablation and sealing device for an interatrial septal ostomy system according to a fifth embodiment of the present application.
  • FIG. 17 is a schematic structural diagram of an interatrial septal ostomy system provided by a sixth embodiment of the present application.
  • FIG. 18 is a schematic diagram of the structure of the ablation sealing device of FIG. 17 to remove the insulating film;
  • FIG. 19 is a schematic structural view of an interatrial septal ostomy system provided by a seventh embodiment of the present application.
  • FIG. 20 is a schematic structural diagram of an interatrial septal ostomy system provided in an eighth embodiment of the present application.
  • 21 is a schematic structural diagram of an interatrial septal ostomy system provided in a ninth embodiment of the present application.
  • FIG. 22 is a schematic view of the structure of the ablation sealing device of FIG. 21 to remove the insulating film;
  • FIG. 23 is a cross-sectional view taken along line XXIII-XXIII in FIG. 21;
  • 25 is a schematic structural diagram of an interatrial septal ostomy system provided in a tenth embodiment of the present application.
  • 26 is a schematic diagram of the structure of the ablation sealing device of FIG. 25 to remove the insulating film;
  • FIG. 27 is a schematic structural diagram of an interatrial septostomy system provided in an eleventh embodiment of the present application.
  • distal means the end far away from the operator during the surgical operation
  • proximal means the end close to the operator during the surgical operation.
  • FIG. 1 is a schematic structural diagram of a first implementation manner of an interatrial ostomy system provided in the first example of the present application
  • FIG. 2 is an interatrial ostomy of the interatrial ostomy system in FIG. 1.
  • the present application provides an atrial septostomy system 100, which includes an atrial septostomy device 20 and a ostomy device control mechanism 50 for controlling the atrial septostomy device 20.
  • the interseptal ostomy device 20 includes a support frame 21 for opening the perforations in the interatrial septum to open the perforations to form the ostomy.
  • the supporting framework 21 is provided with at least one ablation member 210 which contacts the interatrial septal tissue adjacent to the perforation on the interatrial septum and is used to ablate the atrial septal tissue, that is, the atrial septum Except for the ablation member 210, the ostomy device 20 cannot ablate blood or tissue.
  • the ablation member 210 includes at least one electrode for ablation. At least one of the electrodes may be an external electrode or an electrode directly disposed on the support frame 21, and at least one of the electrodes is electrically connected In the radio frequency power supply, at least one of the electrodes receives the energy of the radio frequency power supply to ablate the interatrial septum tissue around the stoma.
  • the atrial septal ostomy device 20 of the interatrial septal ostomy system 100 of the present application includes a support skeleton 21 that extends through the perforation of the interatrial septum, and an ablation member 210 provided on the support skeleton 21, the ablation member 210 is used to
  • the atrial septal tissue around the stoma is ablated, and the support frame 21 is insulated at least on the outer surface of the contact area of the ablation member 210. Therefore, the support frame 21 can open the perforations in the interatrial septum to form a stoma, and ablate the interstitial tissue around the stoma through the ablation member 210.
  • the shape of the treated ostomy is relatively regular, and it is not easy to block, which can keep the opening of the ostomy smooth, and then make the blood flow of the left and right heart chambers smooth.
  • An insulating film 27 is provided between the supporting frame 21 and the ablation member 210, and the insulating film 27 may be, but not limited to, a polytetrafluoroethylene film, a polyurethane film, or a polyimide film.
  • the insulating film 27 can not only isolate the heat conduction between the ablating member 210 and the supporting framework 21, that is, to prevent energy from being transferred to the support On the skeleton 21, so that heat can be concentrated on the ablation member 210 to ablate interstitial tissue and improve energy utilization; and the insulating film 27 can also form an insulating barrier on the side of the ablation member 210 facing the blood, thereby reducing The small current density through the blood reduces the heating of the blood by the ablation member 210 and reduces the risk of thrombosis.
  • the insulating film 27 is provided on the outer wall surface of the support frame 21 corresponding to the ablation member 210. Specifically, the insulating film 27 is connected to the outer wall surface of the support frame 21 by stitching or gluing.
  • the insulating film 27 may also be provided on the surface of the ablation member 210 corresponding to the support skeleton 21, specifically, the insulating film 27 is adhered to the ablation member 210 by means of gluing Facing the outer surface of the support frame 21.
  • the support framework 21 is coated with an insulating coating corresponding to the surface of the ablation member 210, or the ablation member 210 is coated with an insulating coating corresponding to the surface of the support framework 21, and the insulating coating It may be, but not limited to, parylene coating, polytetrafluoroethylene coating, polyurethane coating, or polyimide coating. Since the support framework 21 and the ablation member 210 are insulated by an insulating coating, the energy of the ablation member 210 is not easily transmitted to the support framework 21, and the energy is concentrated on the ablation member 210 to perform interatrial septum Ablation, improve energy utilization.
  • the support skeleton 21 is a self-expanding ostomy device, and the support skeleton 21 may be an elastic metal stent or an elastic non-metal stent.
  • the supporting framework 21 is a nickel alloy stent.
  • the diameter of the supporting framework 21 can be reduced to a smaller state for transport in the sheath; when When the interatrial septal ostomy device 20 is released in the heart, the supporting framework 21 can automatically expand to the desired shape and size, so that the supporting framework 21 can open the stoma on the interatrial septum, that is, the supporting framework 21 is in the The part of the stoma produces radial support for the tissue of the stoma.
  • the support frame 21 can be cut from a nickel alloy tube or braided from nickel alloy wire.
  • the degree of density of the mesh structure supporting the skeleton 21 is set as required.
  • diamond-shaped structural units are continuously arranged in a circle, and the overall shape of the supporting skeleton 21 may be a variety of suitable shapes such as a straight cylinder, a disc, and a cone, which are not limited herein.
  • An insulating coating is applied on both the outer wall surface and the inner wall surface of the support frame 21, and the insulating coating may be, but not limited to, polytetrafluoroethylene coating, polyurethane coating, or polyimide coating.
  • the outer wall surface and the inner wall surface of the support frame 21 are coated with a polytetrafluoroethylene coating.
  • the nickel alloy wire of the support frame 21 may also be covered with an insulating sleeve.
  • the supporting framework 21 includes a cylindrical expansion part 211, a first positioning part 213 provided at one end of the expansion part 211, The opening portion 211 faces away from an extension portion 214 at one end of the first positioning portion 213, and a recovery portion 215 disposed at the end of the extension portion 214 away from the extension portion 211.
  • the expansion part 211 is used to expand the perforation on the interatrial septum to form a stoma; the first positioning part 213 is used to position the support frame 21 into the stoma of the interatrial septum; the extension part 214 can prevent the expansion part 211 from deviating from the stoma when extending to the distal end, which can not expand the tissue there, so that the extension part 214 can compensate for the defects caused by the expansion part 211 deviating from the stoma influences.
  • the expansion portion 211 when the supporting frame 21 is fully released, the expansion portion 211 can expand radially after being released, so that the perforations in the interatrial septum can be evenly expanded, and the perforations in the interatrial septum can be expanded to form a structure. hole.
  • the spreading portion 211 is a continuous circular ring-shaped structure, and the proximal end of the first positioning portion 213 is connected to the spreading portion 211, that is, the first positioning portion 213 and the wave-shaped ring shape The wave crests of the structure are connected, and the distal end of the first positioning portion 213 extends radially to form a tapered surface or a circular surface.
  • the proximal end of the extension portion 214 is connected to the spreading portion 211, that is, the extension portion 214 is connected to the trough of the wave-shaped structure, and the distal end of the extension portion 214 extends axially; the proximal end of the recovery portion 215 Connected to the extension portion 214, the distal end of the recovery portion 215 extends axially and merges.
  • the spreading portion 211 may be a net-shaped support, a rod-shaped support, a multi-layer wave-shaped support, or a tubular structure or a ring structure formed by a combination thereof.
  • the mesh bracket has obvious interlaced warp and weft structure, or has a repeating cell structure, which can be woven or cut, and the interlaced warp and weft parts can be relatively slidable or fixed to each other;
  • the wave support has a multi-loop ring-shaped wave structure , Including wave crests, wave troughs and wave rods, circumferentially adjacent wave rods are connected at the proximal end to form a wave peak, and the distal end is connected to form a wave trough;
  • tubular structure can be understood as extending a distance in the axial direction, for example, the axial size is greater than or equal to the tubular structure
  • the outer diameter of the ring structure is slightly smaller than that of the tubular structure, which is generally smaller than the outer diameter of
  • the shape of the spreading portion 211 may be various, for example, the spreading portion 211 may be concave, or / and convex, curved, cylindrical, oval, or a combination thereof.
  • the curved shape is to form a closed curved structure in the circumferential direction.
  • the positions of the convex and concave can be set according to the needs.
  • the convex or concave structure can be formed separately, or the convex or concave structure can be combined and set in On the same spreading part 211.
  • the convex structure such as a disc shape, a ball table shape, etc., and the concave structure such as a waist drum shape.
  • a cylindrical structure is used, which smoothly transitions from the straight cylindrical shape of the support frame 21 to form an overall cylindrical structure.
  • the axial length of the spreading portion 211 is set according to actual needs, and generally matches the thickness of the interatrial septum.
  • the recovery part 215 has a conical shape, and the proximal end of the recovery part 215 is connected to the extension part 214.
  • the distal end of the recovery part 215 merges with a connecting piece 2152.
  • the connecting piece 2152 is used to connect a stoma device control mechanism 50.
  • the recovery part 215 includes a plurality of extension pieces 2151 connected between the extension part 214 and the connector 2152, and the connector 2152.
  • the connecting member 2152 is a tubular structure, and the outer diameter of the tubular structure in the released state is smaller than the outer diameter of the extended portion 214 in the released state.
  • the connecting member 2152 is provided with a plurality of fixing holes 2154 along the circumferential direction.
  • the fixing holes 2154 are used to fix the connecting member 2152 to the ostomy device control mechanism 50.
  • the ablation member 210 is disposed on the spreading portion 211. Specifically, the ablation member 210 is disposed on an outer wall surface of the spreading portion 211. The ablation member 210 and the spreading portion 211 The insulating film 27 is disposed between the outer wall surfaces, and the area of the ablation member 210 projected onto the insulating film 27 is located in the insulating film 27, that is, the area of the ablation member 210 projected on the insulating film 27 is less than or equal to the area of the insulating film 27.
  • the ablation member 210 is an external electrode.
  • the ablation member 210 is a unipolar electrode.
  • the unipolar electrode is connected to a radio frequency source and used in conjunction with an external neutral electrode plate to organize the interatrial septum. Perform ablation.
  • the external electrode refers to an electrode that is independent of the support frame 21 and is connected to the support frame 21 by means of gluing or stitching.
  • the ablation member 210 includes a plurality of flexible wires 2102, an ablation portion 2104 disposed at the proximal end of each wire 2102, and a connection portion 2105 disposed at the distal end of each wire 2102.
  • Each wire 2102 is stitched to the outer wall surface of the support frame 21 by gluing or stitching.
  • the ablation portion 2104 of each wire 2102 is located on the outer wall surface of the expansion portion 211, and these ablation portions 2104 are provided at least one turn along the circumferential direction of the expansion portion 211; the connection portion 2105 of each wire 2102 extends axially
  • the connecting piece 2152 is connected and electrically connected to the radio frequency source.
  • the wire 2102 includes a flexible metal layer 2106, an insulating layer 2107 sleeved over the metal layer 2106, and an insulating layer 2107 glued to the wire 2102 is used to connect the wire 2102 is adhered to the adhesive layer 2108 on the support frame 21.
  • the ablation part 2104 removes the insulating layer 2107 on the side facing away from the adhesive layer 2108 at the proximal end of the lead 2102; the connection part 2105 removes the insulating layer 2107 and adhesive at the distal end of the lead 2102 Level 2108.
  • the insulating film 27 is further provided between the ablation portion 2104 and the spreading portion 211.
  • the insulating film 27 is a ring-shaped structure covering the circumference of the outer wall surface of the spreading portion 211.
  • the film 27 is stitched around the outer wall surface of the spreading portion 211 by a suture, so that the ablation portion 2104 and the spreading portion 211 are insulated.
  • the control mechanism 50 of the ostomy device includes a pushing member 52, an outer sheath assembly 54, and a control handle 56.
  • the pushing member and the interstitial stoma device can be set as a detachable connection or an integral fixed connection.
  • the pushing member 52 and the interstitial stoma device 20 are integrally fixedly connected, and the pushing member 52
  • the lead wire 521 is provided, and the lead wire 521 is electrically connected to the connecting portion 2105 of the interseptal stoma device 20.
  • the pushing member 52 includes a double-lumen tube 520 and a connecting sleeve 523 sleeved on the outer wall of the proximal end of the double-lumen tube 520.
  • the proximal outer wall surface of the double-lumen tube 520 is circumferentially provided with a receiving port 5202
  • the connecting sleeve 523 is sleeved on the double-lumen tube 520 and received in the receiving port 5202.
  • the outer surface of the connecting sleeve 523 is aligned with the outer surface of the dual-lumen tube 520.
  • the double-lumen tube 520 is made of polyethylene or other polymer materials.
  • the double-lumen tube 520 includes an axially extending first cavity 5201 and a second cavity 2503.
  • the first cavity 5201 is used to place a sheath core, and the second cavity 2503 is used to receive a wire 521.
  • the proximal end of the pushing member 52 and the connecting member 2152 of the distal end of the atrial septostomy device 20 are connected by a mechanism.
  • connection sleeve 523 is a tube made of conductive metal, the proximal end of the connection sleeve 523 is sleeved with the distal end of the connection piece 2152, and the proximal end of the wire 521 in the pushing piece 52 After passing through the wall of the double-lumen tube 520 and welding to the connecting sleeve 523, the distal end of the wire 521 extends along the second cavity 2503 until it is connected to the radio frequency power source.
  • the connection portion 2105 of the flexible wire 2102 of the ablation member 210 is welded to the outer wall surface of the connection sleeve 523.
  • the connecting sleeve 523 and the connecting piece 2152 are also sleeved with a protective tube 527, which is made of polytetrafluoroethylene, polyurethane or polyimide and other insulating materials.
  • the protective tube 527 is near The end sleeve is disposed on the outer wall surface of the connection sleeve 523 and the connection piece 2152.
  • the distal end of the protection tube 527 extends backward from the proximal end of the pushing piece 52 until it covers a length behind the connection sleeve 523.
  • the connection portion 2105 of each lead 2102 of the ablation member 210 is located between the connection sleeve 523 and the protection tube 527. All materials at the connection sleeve 523 are also fused together, and the welding place is completely fused inside the material, thereby ensuring the safety and reliability of the electrical connection.
  • the outer sheath tube assembly 54 includes a sheath tube 540 having a sheath lumen 541 and a sheath core 543.
  • the pushing member 52 is located in the sheath lumen 541, and the sheath core 543 is located in the first cavity 5201 of the pushing member 52.
  • the sheath core 543 includes a PEEK tube 5432 having a cavity, and a plug 5434 disposed at the front end of the PEEK tube 5432 and matched with the sheath tube 540.
  • the PEEK tube 5432 is accommodated in the first cavity 5201 of the pusher 52, and the plug 5434 has a guiding function when the interatrial septal ostomy device 20 is inserted into the perforation of the interatrial septum.
  • the rear ends of the pushing member 52, the sheath tube 540, and the sheath core 543 are respectively connected to the control handle 56.
  • the distal end connected to the control handle 56 is provided with a connector 562 connected to the radio frequency power supply.
  • the distal end of the wire 521 of the pusher 52 is electrically connected to the joint 562.
  • the control handle 56 is provided with mutually independent motion mechanisms, which can realize the independent movement of the pushing member 52, the sheath tube 540, and the sheath core 543.
  • the atrial septostomy device 20 the pusher 52, the sheath core 543, the sheath tube 540, and the control handle 56 are a complete system.
  • the operation procedure of the interatrial ostomy system in this embodiment is as follows:
  • the puncture mechanism is used to puncture the interatrial septum 601. After the puncture, the guide wire is fed into the left upper pulmonary vein 605 and the puncture kit is withdrawn;
  • Withdrawing the sheath tube 540 completely removes the sheath from the first positioning portion 213 of the atrial septostomy device 20, and the first positioning portion 213 is fully opened. It is determined whether the first positioning portion 213 is fully opened by ultrasound or DSC. In the process, it is necessary to ensure that the distal end of the sheath 540 is always in the left atrium. Then maintain no relative movement between the instruments and pull the sheath 540 backward so that the first positioning portion 213 is tightly attached to the surface of the interatrial septum 601 facing the left atrium;
  • sheath tube 540 completely removes the sheath 211 of the atrial septal ostomy device 20, judging by ultrasound or DSC, and opening the atrial septum 601 into a small hole, that is, forming a stoma 603 on the atrial septum 601 ;
  • the ablation member 210 make good contact with the tissue of the interatrial septum 601, and then set the heating parameters (such as power 30W, duration 120S), and then start heating.
  • the heating parameters such as power 30W, duration 120S
  • the spreading portion 211 of the interstitial space ostomy device 100 of the interstitial space ostomy system 100 expands the perforation in the interatrial space to form a stoma
  • the ablation member 210 on the spreading portion 211 can The tissue on the inner wall of the stomal is separated to prevent the endothelium from covering the stomal to block the stomal and keep the stomal smooth
  • the insulating film 27 can be formed on the ablation member 210 and the blood-facing side Insulation barrier, reduces the current density through the blood, reduces the heating of the blood by the current, and reduces the risk of thrombosis
  • the interatrial ostomy device 20 can be recovered after the ostomy is completed, that is, the atrial septostomy The device 20 does not need to remain in the interatrial septum, thereby preventing the instrument from falling off and forming an embolism.
  • FIG. 12 is a schematic structural diagram of an ablation plugging device for an interatrial septal ostomy system according to a second embodiment of the present application
  • FIG. 13 is a front partial cross-sectional view of the ablation plugging device in FIG. 12.
  • the structure of the ablation sealing device provided in the second embodiment of the present application is similar to the structure of the first embodiment, except that in the second embodiment, the supporting framework 21 of the interatrial septal ostomy device 20a is also self-expanding Nickel alloy stent, the interatrial septal ostomy device 20a, when fully released, also includes a cylindrical expansion portion 211, a first positioning portion 213, an extension portion 214, and a recovery portion 215, of which the first positioning portion 213 is located at one end of the spreading portion 211, and the extending portion 214 is located at the end of the spreading portion 211 away from the first positioning portion 213.
  • the proximal end of the recovery portion 215 is connected to the end of the extension portion 214 away from the spreading portion 211, and the distal end of the recovery portion 215 is retracted by the connector 2152.
  • the connecting member 2152 is cylindrical, and a positioning member 2155 is provided in the connecting member 2152.
  • the positioning member 2155 is glued, snapped, or screwed into the connecting member 2152.
  • the positioning member 2155 is a metal conductive member.
  • the positioning member 2155 is a metal nut.
  • the inner surface of the connecting member 2152 is provided with internal threads.
  • the positioning member 2155 is screwed into the connecting member 2152. .
  • a screw hole 2157 is axially opened in the middle of the positioning member 2155, and the screw hole 2157 is used to connect the pushing member 52.
  • the positioning member 2155 and the connecting member 2152 are insulated.
  • the positioning member 2155 may have an interference fit with the connecting member 2152, so that the positioning member 2155 is snapped into the connecting member 2152; the positioning member 2155 may also be connected to the connecting member 2152 by gluing .
  • one end of the flexible wire 2102 on the support frame 21 is electrically connected to the ablation member 210a, and the other end of the flexible wire 2102 is electrically connected to the positioning member 2155.
  • the flexible wire 2102 is located in the support frame 21, one end of the flexible wire 2102 passes through the support frame 21 and is welded to the ablation member 210a, and the other end of the flexible wire 2102 is welded to the positioning member 2155.
  • the positioning member 2155 is electrically connected to the radio frequency power source through the wire in the pushing member 52.
  • the positioning member 2155 may also be made of a non-conductive material, the positioning member 2155 is axially provided with a threading hole, and the end of the flexible wire 2102 on the supporting frame 21 away from the ablation member 210a passes through The threading hole is directly electrically connected to the radio frequency power supply.
  • a plurality of through holes 2112 are formed in the spreading portion 211, and the through holes 2112 are arranged in a circle along the circumferential direction of the spreading portion 211.
  • One end of the flexible wire 2102 passes through one of the through holes 2112 and is electrically connected to the ablation member 210a.
  • Development marks 2114 are provided in the other through holes 2112, that is, these development marks 2114 surround the expansion portion 211 once, so as to facilitate the implantation and positioning of the support frame 21.
  • the developing mark 2114 is provided in the corresponding through hole 2112 by mechanical, welding or bonding.
  • the material of the developing mark 2114 can be selected from, but not limited to: gold, platinum, platinum-tungsten, palladium, platinum-iridium, rhodium, tantalum, or alloys or composites of these metals.
  • the first positioning portion 213 is a disk-shaped structure formed by radiating radially from a connection point connecting the end of the expansion portion 211, and the diameter of the disk-shaped structure is larger than the diameter of the expansion portion 211.
  • the first positioning portion 213 is configured as a circular single-layer planar structure, and the circular single-layer planar structure can be used as a positioning structure for fixing the position of the spreading portion 211.
  • the first positioning portion 213 further includes an outer edge tilting structure, and the outer edge tilting structure is a smooth transition curved from the outer edge portion of the first positioning portion 213 to a side away from the spreading portion 211, Avoid damage to atrial tissue.
  • the planar structure of the first positioning portion 213 at least partially fits the surface of the interatrial septum facing the left atrium, and the ablation member 210a is located between the first positioning portion 213 and the surface of the atrial septum facing the left atrium, so that the ablation The member 210a contacts the surface of the interatrial septum facing the left atrium.
  • the ablation member 210a is a ring electrode connected or spaced at least one turn along the circumferential direction of the spreading portion 211, and the ring electrode is an external electrode.
  • the ablation member 210a is a ring-shaped electrode disposed around the spreading portion 211, and the radial distance between the ring-shaped electrode and the spreading portion 211 can be set to 0-5 mm, preferably 3 mm.
  • the ablation element 210a is a continuous ring-shaped, highly elastic and flexible metal wire. Such as nickel-titanium multi-strand wire, or gold-coated nickel-titanium multi-strand wire and other structures.
  • the ablation member 210a may be attached to the first positioning portion 213 by suture stitching and / or binding. One end of the wire 2102 is welded to the ring electrode, and the other end is electrically connected to the positioning member 2155.
  • the inner and outer surfaces of the support frame 21 are coated with an insulating layer, for example, coated with Parylene insulating coating, so that the ablation member 210a and the support frame 21 are insulated from each other.
  • an insulating film 27a is provided between the ablation member 210a and the first positioning portion 213.
  • the insulating film 27a is provided in a ring structure.
  • the insulating film 27a includes a first ring-shaped insulating film 271 covering the first positioning portion 213 adjacent to the expansion portion 211, and covering the expansion portion 211 adjacent to the first positioning
  • the second ring-shaped insulating film 273 at the portion 213 is round.
  • the ablation member 210a and the first positioning portion 213 can be isolated, which not only can isolate the heat conduction between the first positioning portion 213 and the support frame 21, and prevent energy from being transferred to the support frame 21, thereby concentrating the energy on the ablation On the piece 210a, to ablate the tissue of the interatrial septum facing the left atrium around the stoma to improve energy utilization; and the insulating film 27a can form an insulating barrier on the blood-facing side of the ablation piece 210a to reduce the passage of blood The current density reduces the current heating of the blood and reduces the risk of thrombosis.
  • the insulating film 27a may only include the first annular insulating film 271 covering the first positioning portion 213 adjacent to the spreading portion 211, that is, the insulating film 27a may omit the second annular insulating film 273.
  • the first annular insulating film 271 is used to isolate the ablation member 210a from the first positioning portion 213.
  • the positioning member 2155 is connected to the pushing member, that is, the proximal end of the pushing member can be screwed to the positioning member 2155, that is, the positioning member 2155 is connected to the pushing member through the screw hole 2157 of the positioning member 2155.
  • the wire in the pushing member is electrically connected to the positioning member 2155, so that the ablation member 210a is electrically connected to the radio frequency power source through the flexible wire 2102, the positioning member 2155 and the wire in the pushing member.
  • the interatrial septostomy system When using the interatrial septostomy system in this embodiment, it needs to be used in conjunction with a loader, a sheath tube, a sheath core, a conductive pusher, a radio frequency power supply and a power connection line, and a neutral electrode plate.
  • a loader When using the interatrial septostomy system in this embodiment, it needs to be used in conjunction with a loader, a sheath tube, a sheath core, a conductive pusher, a radio frequency power supply and a power connection line, and a neutral electrode plate.
  • the spreading portion 211 of the inter-atrial septostomy device 20a can expand the perforation in the interatrial septum to form a stoma.
  • the ablation member 210a on the first positioning portion 213 can The tissue around the stoma is separated from the room, so that the endothelium near the stoma can be blocked to block the stoma, prevent the stoma from being blocked, and keep the stoma open; second, the insulating film 27 also An insulating barrier may be formed on the side of the ablation member 210a facing the blood, thereby reducing the current density through the blood, reducing the heating of the blood by the ablation member 210a, and reducing the risk of thrombosis.
  • the interatrial ostomy device 20a After the ostomy is completed, it can be recovered, that is, the interatrial septal ostomy device 20a does not need to remain on the atrial septum, thereby preventing the instrument from falling off and forming an embolism.
  • the ablation member 210a may be an annular electrode disposed on the outer wall surface of the expansion portion 211 at least once around the expansion portion 211.
  • the ablation element 210a and the expansion portion 211 An insulating film 27a is provided between the wall surfaces.
  • the ablation member 210a may be a wave-shaped ring electrode surrounding at least one turn of the expansion part 211 and the outer wall surface of the expansion part 211 and the first positioning part 213, that is, the wave Part of the ring-shaped electrode is located on the outer wall surface of the spreading portion 211, the other part is located on the outer wall surface of the first positioning portion 213, the ablation member 210a and the spreading portion 211 and the first positioning portion 213 outside An insulating film 27a is provided between the wall surfaces.
  • FIG. 14 is a schematic structural diagram of an ablation sealing device of an interatrial septal ostomy system according to a third embodiment of the present application.
  • the structure of the ablation plugging device provided by the third embodiment of the present application is similar to the structure of the first embodiment, except that the structure of the ablation member in the third embodiment is different from the first embodiment.
  • the ablation member 210b of the ablation plugging device 20b includes a plurality of spaced dot-shaped electrodes, and the dot-shaped electrodes are external electrodes, and these dot-shaped electrodes are provided at least one turn along the circumferential direction of the outer wall surface of the support frame 21.
  • these dot-shaped electrodes are circumferentially arranged along the outer wall surface of the spreading portion 211, and the ablation member 210b and the support frame 21 are insulated.
  • the insulation treatment method is to apply an insulating coating on the outer wall surface of the support frame 21 in contact with the point electrode, or insert an insulating sleeve on the metal wire in contact with the point frame electrode, the insulating sleeve
  • An outer wall surface of the metal wire wrapped around the support frame 12 is provided with an insulating film 27 between the ablation member 210b and the support frame 21.
  • the insulating coating or sleeve material may be selected from FEP / ETFE / PFA, and the insulating film 27 may be, but not limited to, polytetrafluoroethylene film, polyurethane film, or polyimide film.
  • These dot-shaped electrodes are used as ablation electrodes. These dot-shaped electrodes are electrically connected to the flexible lead 2102 through a wire in series, and the flexible lead 2102 is provided with the connecting piece 2152, the connecting sleeve 523, and the pushing piece. The wire is electrically connected to the RF power supply.
  • the interatrial septostomy system When using the interatrial septostomy system in this embodiment, it needs to be used in conjunction with a loader, a sheath tube, a sheath core, a conductive pusher, a radio frequency power supply and a power connection line, and a neutral electrode plate.
  • a loader When using the interatrial septostomy system in this embodiment, it needs to be used in conjunction with a loader, a sheath tube, a sheath core, a conductive pusher, a radio frequency power supply and a power connection line, and a neutral electrode plate.
  • the expansion part 211 of the interstitial stoma device 20b expands the perforation in the interatrial septum to form a stoma.
  • the ablation member 210b on the expansion part 211 can The tissue on the inner wall of the stoma is dissected, so that the endothelium near the stoma can be blocked to block the stoma, preventing the stoma from being blocked, and keeping the stoma open; secondly, the insulating film 27 can also be ablated
  • the side of the member 210b facing the blood forms an insulating barrier, thereby reducing the current density through the blood, reducing the heating of the blood by the ablation member 210b, and reducing the risk of thrombosis.
  • the atrial septal ostomy device 20b is completed. It can be recovered after the oral cavity, that is, the interatrial septal ostomy device 20b does not need to remain in the interatrial septum, thereby preventing the instrument from falling off and forming an embolism.
  • At least one circle of dot-shaped electrodes may be disposed on the outer wall surface of the first positioning portion 213 facing the spreading portion 211, and an insulating film 27 is provided between the at least one circle of dot-shaped electrodes and the first positioning portion 213 .
  • FIG. 15 is a schematic structural diagram of an ablation sealing device of an interatrial septal ostomy system according to a fourth embodiment of the present application.
  • the structure of the ablation plugging device provided in the fourth embodiment of the present application is similar to the structure of the first embodiment, except that the structure of the ablation member in the fourth embodiment is different from the first embodiment.
  • the ablation member 210c of the ablation plugging device 20c is a single-ring intermittent ring-shaped electrode provided in the circumferential direction of the outer wall of the support frame 21, the ring electrode is an external electrode, and the ring electrode is insulated from the support frame 21 deal with.
  • a single-ring intermittent ring-shaped electrode is provided on the outer wall surface of the spreading portion 211, and an insulating film 27 is provided between the ring-shaped electrode and the spreading portion 211.
  • the ring electrode is electrically connected to the wire 2102 through a wire in series, and the wire 2102 is connected to the radio frequency power supply.
  • the interatrial septostomy system When using the interatrial septostomy system in this embodiment, it needs to be used in conjunction with a loader, a sheath tube, a sheath core, a conductive pusher, a radio frequency power supply and a power connection line, and a neutral electrode plate.
  • a loader When using the interatrial septostomy system in this embodiment, it needs to be used in conjunction with a loader, a sheath tube, a sheath core, a conductive pusher, a radio frequency power supply and a power connection line, and a neutral electrode plate.
  • the spreading portion 211 of the interstitial space ostomy device 20c can expand the perforation in the interatrial septum to form a stoma.
  • the ablation member 210c on the spreading portion 211 can The tissue on the inner wall of the stoma is dissected to prevent the endothelium covering the stoma from clogging the stoma, preventing the stoma from being blocked, and keeping the stoma open; second, the insulating film 27 can also be The ablation member 210c forms an insulating barrier on the side facing the blood, thereby reducing the current density through the blood, reducing the heating of the blood by the ablation member 210c, and reducing the risk of thrombosis.
  • the atrial septostomy device 20c is completed It can be recovered after the stoma, that is, the interatrial septal ostomy device 20c does not need to remain on the interatrial septum, thereby preventing the instrument from falling off and forming an embolism.
  • a single-turn intermittent ring-shaped electrode may be disposed on the outer wall surface of the first positioning portion 213 facing the expansion portion 211, and a single-turn intermittent ring-shaped electrode may be provided between the first positioning portion 213 There is an insulating film 27.
  • FIG. 16 is a schematic structural diagram of an interatrial ostomy device of an interatrial ostomy system provided by a fifth embodiment of the present application.
  • the structure of the ostomy system provided by the fifth embodiment of the present application is similar to the structure of the second embodiment, except that the structure of the ablation member in the fifth embodiment is different from the second embodiment.
  • the ablation member 210d of the interseptal ostomy device 20d includes a plurality of spaced rod electrodes.
  • the rod electrodes are external electrodes, and each rod electrode extends along the axial direction of the support frame 21. Set at least one circle in the circumferential direction.
  • these rod-shaped electrodes are provided at least one turn along the outer wall surface of the spreading portion 211, and the ablation member 210d and the support frame 21 are insulated.
  • the insulation treatment method is to apply an insulating coating on the outer wall surface of the support frame 21 in contact with the rod-shaped electrode, or insert an insulating sleeve on the metal wire in contact with the rod-shaped electrode, the insulating sleeve
  • An insulating film 27a is provided between the ablation element 210d and the support frame 21 on the outer wall surface of the metal wire wrapped around the support frame 21.
  • the insulating coating or sleeve material may be selected from FEP / ETFE / PFA, and the insulating film 27 may be a polytetrafluoroethylene film, a polyurethane film, or a polyimide film.
  • the interatrial septostomy system in this embodiment needs to be used in combination with a loader, a sheath tube, a sheath core, a conductive pusher, a radio frequency power supply and a power connection line, and a neutral electrode plate.
  • the specific use flow and method are the same as those in the second embodiment, and will not be repeated here.
  • the expansion part 211 of the interatrial ostomy device 20d of the interatrial ostomy system in this embodiment can expand the perforation in the interatrial septum to form a stoma, and the ablation member 210d on the expansion part 211 can
  • the tissue on the inner wall of the stoma is dissected, which can prevent the endothelium covering the stoma from clogging the stoma, preventing the stoma from being blocked, and keeping the stoma open;
  • the insulating film 27a can also be
  • the ablation member 210d forms an insulating barrier on the side facing the blood, thereby reducing the current density through the blood, reducing the heating of the blood by the ablation member 210d, and reducing the risk of thrombosis.
  • the atrial septostomy device 20d is completed It can be recovered after the ostomy, that is, the interatrial septal ostomy device 20d does not need to remain on the atrial septum, thereby preventing the instrument from falling off and forming an embolism.
  • At least one circle of rod-shaped electrodes may be disposed on the outer wall surface of the first positioning portion 213 facing the spreading portion 211, and at least one circle of rod-shaped electrodes is disposed between the first positioning portion 213 There is an insulating film 27a.
  • FIG. 17 is a schematic structural diagram of an interatrial septal ostomy system provided in a sixth embodiment of the present application
  • FIG. 18 is a schematic structural diagram of the interatrial septal ostomy system in FIG. 17 after removing an insulating film.
  • the structure of the interatrial septal ostomy system provided in the sixth embodiment of the present application is similar to that of the first embodiment, except that in the sixth embodiment, in a state where the atrial septal ostomy device 20e is completely released
  • the support frame 21a includes a cylindrical expansion portion 211, a first positioning portion 213a provided at one end of the expansion portion 211, and a second positioning portion provided at the opposite end of the expansion portion 211 217; the proximal end of the first positioning portion 213a is connected to the spreading portion 211, the distal end extends axially and merges; the proximal end of the second positioning portion 217 is connected to the spreading portion 211, the distal end Extend axially and merge.
  • the support skeleton 21a is a braided mesh nickel-titanium alloy stent.
  • the diameter of the support skeleton 21a can be reduced to a smaller state for delivery in the sheath; when When released in the heart, it can automatically expand to the desired shape and size, and the expansion portion 211 can produce a certain radial support effect on the perforated inner wall tissue of the interatrial septum in contact with it, and can expand the perforation to Forming a stoma;
  • the first positioning portion 213a is located in the left atrium and is at least partially attached to the surface of the interatrial septum facing the left atrium, and the second positioning portion 217 is located in the right atrium and at least partially attached to the back of the atrial septum Facing the surface of the left atrium, so that the spreader 211 can be positioned within the stoma of the interatrial septum.
  • the first positioning portion 213a includes a positioning surface 2132 radially extending from an end edge of the spreading portion 211 to form a planar or near-planar conical or curved surface, and connected to the positioning surface 2132
  • the first thrombus catching cage 2133 at the outer edge and toward the end away from the spreading portion 211 is tapered.
  • the distal end of the first thrombus catching cage 2133 is closed to form a first closing surface 2135, the first closing surface 2135 is a conical cone surface, and the distal ends of the first closing surface 2135 merge into one Vertex 2136.
  • the outer surface of the first thrombosis catching cage 2133 is not in contact with the interatrial septum, and the apex 2136 is used for the apex 2136 to smoothly pass through the perforation of the interatrial septum when the interatrial septostomy device 20e is implanted .
  • the second positioning portion 217 includes a positioning surface 2172 that extends radially from an end edge of the spreading portion 211 to form a planar or near-planar conical or curved surface, and is connected to the positioning surface 2172 At the outer edge and toward the end away from the spreading portion 211, a cone-shaped second thrombus catching cage 2173 extends.
  • the distal end of the second thrombus catching cage 2173 is closed to form a second closing surface 2175
  • the second closing surface 2175 is a conical cone surface
  • the distal ends of the second closing surface 2175 merge into one Cone top 2176.
  • the outer surface of the second thrombus catching cage 2173 is not in contact with the interatrial septum, and the cone top 2176 is used to connect the proximal end of the pushing member 52a.
  • two ablation members 210e are provided.
  • One ablation member 210e is provided with at least one ring of connected or spaced ring electrodes along the circumferential direction of the expansion portion 211, and the other ablation member 210e is provided on the first At least one ring of connected or spaced ring electrodes is provided on the positioning surface 2172 of the two positioning portions 217 and along the circumferential direction of the spreading portion 211, and both of the ring electrodes are external electrodes.
  • the ablation member 210e on the spreading portion 211 is a continuous ring electrode; the ablation member 210e on the positioning surface 2172 of the second positioning portion 217 is also a continuous ring electrode, the ring electrode
  • the radial distance from the spreading portion 211 may be set to 0-5 mm, preferably 3 mm.
  • Each ring-shaped electrode is a metal wire or sheet with high elasticity and flexibility, such as a nickel-titanium multi-strand wire or a gold-spring-coated nickel-titanium multi-strand wire.
  • Each ablation member 210e is sutured or glued to the support frame 21a with a suture.
  • Each ablation member 210e is insulated from the support frame 21a. Specifically, the inner and outer surfaces of the support frame 21a are coated with an insulating layer, such as a Parylene insulating coating, so that the ablation member 210e and the support frame 21a are insulated from each other.
  • an insulating layer such as a Parylene insulating coating
  • an insulating film 27 is provided between the outer wall surface of the spreading portion 211 and the corresponding ablation member 210e, and an insulating film 27 is also provided between the outer wall surface of the second positioning portion 217 and the corresponding ablation member 210e;
  • the insulating film 27 on the spreading portion 211 covers the outer wall surface of the spreading portion 211, and the insulating film 27 on the outer wall surface of the second positioning portion 217 covers the outer wall surface of the second positioning portion 217, and extends to The second thrombus caught on cage 2173.
  • the insulating film 27 on the spreading portion 211 and the insulating film 27 on the outer wall surface of the second positioning portion 217 may be two separate insulating films or may be combined into one insulating film.
  • the ablation member 210e and the support skeleton 21a can be isolated, and not only the heat conduction between the ablation member 210e and the support skeleton 21a can be isolated, preventing energy from being transferred to the support skeleton 21a, thereby concentrating energy on the ablation member 210e,
  • the insulating film 27 can form an insulating barrier on the side of the electrode facing the blood and reduce the passage The current density of blood reduces the heating of blood by current and reduces the risk of thrombosis.
  • Each ablation element 210e is electrically connected to a radio frequency power source through a wire 521, and the outer surface of the wire 521 is insulated. Specifically, one end of the lead wire 521 is connected to the corresponding ablation member 210e by welding, and the other end of the lead wire 521 is connected to the radio frequency power supply via the second thrombosis catching cage 2173, the cone top 2176, and the pushing member 52a.
  • the polarity selection of the ablation element 210e on the spreading portion 211 and the ablation element 210e on the second positioning portion 217 includes but is not limited to the following three schemes:
  • the ablation element 210e on the spreading portion 211 and the ablation element 210e on the second positioning portion 217 are both connected to the same radio frequency output port through a wire 521, and the neutral electrode plate is connected to the radio frequency power supply circuit end.
  • the ablation element 210e on the spreading portion 211 is connected to the RF output port through the wire 521, and the ablation element 210e on the second positioning portion 217 is connected to the RF power supply circuit end through the wire 521 without a neutral electrode plate.
  • the ablation element 210e on the second positioning portion 217 is connected to the RF output port through the wire 521, and the ablation element 210e on the expansion portion 211 is connected to the RF power supply circuit end through the wire without a neutral electrode plate.
  • the expansion portion 211 expands the perforation of the interatrial septum to form a ostomy; the first thrombosis cage 2133 is deployed in the left atrium, and the first positioning portion 213a
  • the positioning surface 2132 is attached to the interatrial septum
  • the second thrombus catching cage 2173 is deployed in the right atrium
  • the positioning surface 2172 of the second positioning portion 217 is attached to the interatrial septum to fix the three-dimensional space area near the heating area of the atrial septum Enveloped to prevent emboli formed by blood from heating into the circulatory system and prevent embolism.
  • the pushing member 52a is a solid structure
  • the pushing member body is made of an insulating polymer material
  • the cone tip 2176 of the second positioning portion 217 of the interatrial ostomy device 20e and the proximal end of the pushing member body are melted by heat Or adhesive.
  • the wire 521 extends to the tail end through the pushing member 52a and is electrically connected to the tail end connector 562.
  • the connector 562 is used to electrically connect the radio frequency power supply.
  • the interatrial septostomy device 20e in this embodiment When the interatrial septostomy device 20e in this embodiment is used, it needs to be used in conjunction with a loader, a sheath tube, a sheath core, a radio frequency power supply and a power connection line, and a neutral electrode plate.
  • the method of use is as follows:
  • the guide wire was fed into the left upper pulmonary vein, and the puncture kit was removed. Push the sheath core and sheath tube into the left atrium along the guide wire, and remove the guide wire and sheath core.
  • interatrial septostomy device 20e Choose a suitable size of interatrial septostomy device 20e.
  • the pusher is passed through the proximal end of the loader, and the distal end of the interatrial septostomy device 20e is connected to the proximal end of the pusher.
  • the retractor pushes the interatrial septostomy device 20e into the loader.
  • the expansion part 211 is accommodated in the perforation of the interatrial septum, and the expansion part 211 is fully expanded to expand the perforation to form a stoma, and the first thrombus grasps
  • the positioning surface 2132 on the cage 2133 abuts on the surface of the interatrial septum.
  • the sheath tube is withdrawn, so that the second thrombus catching cage 2173 of the second positioning portion 217 is fully opened.
  • the second thrombus catching cage 2173 is located in the right atrium
  • the positioning surface 2172 on the inner and second thrombus capture cage 2173 is closely attached to the surface of the interatrial septum facing away from the left atrium.
  • the distal end of the pusher After confirming that the ablation part 210e on the spreading part 211 and the second positioning part 217 are completely fitted to the interatrial septum, connect the distal end of the pusher to the RF power supply, and set the heating parameters (such as power 50W, duration 30S), and then start heating.
  • the heating parameters such as power 50W, duration 30S
  • the interatrial septal ostomy device 20e can be recovered to the sheath and removed from the body, and it is measured whether the diameter of the ostomy is as expected.
  • the distal end of the first positioning portion 213a extends radially to form a plurality of positioning rods, the positioning rods are conical or circular, and the ablation member 210e is disposed on the positioning rods So that the ablation member 210e contacts the interatrial septum.
  • the positioning surface 2132 is provided with a plurality of positioning points, and the ablation element 210e is arranged on the positioning point, so that the ablation element 210e contacts the interatrial septum.
  • a plurality of positioning rods are provided on the positioning surface 2132, and the ablation member 210e is disposed on the positioning rod, so that the ablation member 210e contacts the interatrial septum.
  • FIG. 19 is a schematic structural diagram of an interatrial septostomy system provided in a seventh embodiment of the present application.
  • the structure of the atrial septostomy system provided in the seventh embodiment of the present application is similar to that of the sixth embodiment, except that in the seventh embodiment, the positioning of the first positioning portion 213a of the atrial septostomy device 20f On the surface 2132, at least one ring of connected or spaced ring electrodes 210e is provided in the circumferential direction of the spreading portion 211, and at least one ring of connected or spaced ring electrodes 210e is provided in the circumferential direction of the spreading portion 211.
  • the ring electrodes are external electrodes.
  • the ablation element 210e on the spreading portion 211 is a continuous ring electrode; the ablation element 210e on the positioning surface 2132 of the first positioning portion 213a is a continuous ring electrode, and the ring electrode
  • the radial distance from the spreading portion 211 may be set to 0-5 mm, preferably 3 mm.
  • Each ring-shaped electrode is a metal wire or sheet with high elasticity and flexibility, such as a nickel-titanium multi-strand wire or a gold-spring-coated nickel-titanium multi-strand wire.
  • Each ablation member 210e is sutured or glued to the support frame 21a with a suture.
  • An insulating film 27 is provided between the outer wall surface of the spreading portion 211 and the corresponding ablation material 210e, and an insulating film 27 is also provided between the outer wall surface of the first positioning portion 213a and the corresponding ablation material 210e.
  • the insulating film 27 on the spreading portion 211 covers the outer wall surface of the spreading portion 211, and the insulating film 27 on the outer wall surface of the first positioning portion 213a covers the outer wall surface of the positioning surface 2132 and extends to the first The thrombus catches the cage 2133.
  • the insulating film 27 on the spreading portion 211 and the insulating film 27 on the outer wall surface of the first positioning portion 213a may be two separate insulating films or may be combined into one insulating film.
  • the ablation member 210e and the support skeleton 21a can be isolated, and not only the heat conduction between the ablation member 210e and the support skeleton 21a can be isolated, preventing energy from being transferred to the support skeleton 21a, thereby concentrating energy on the ablation member 210e,
  • the insulating film 27 can form an insulating barrier on the side of the electrode facing the blood and reduce the passage The current density of blood reduces the heating of blood by current and reduces the risk of thrombosis.
  • the interatrial septostomy system When using the interatrial septostomy system in this embodiment, it needs to be used in conjunction with a loader, a sheath tube, a sheath core, a conductive pusher, a radio frequency power supply and a power connection line, and a neutral electrode plate.
  • a loader When using the interatrial septostomy system in this embodiment, it needs to be used in conjunction with a loader, a sheath tube, a sheath core, a conductive pusher, a radio frequency power supply and a power connection line, and a neutral electrode plate.
  • FIG. 20 is a schematic structural diagram of an interatrial septal ostomy system according to an eighth embodiment of the present application.
  • the structure of the interatrial septal ostomy system provided in the eighth embodiment of the present application is similar to that of the sixth embodiment, except that in the eighth embodiment, the positioning of the first positioning portion 213a of the interatrial ostomy device 20g
  • At least one ring of connected or spaced ring electrodes 210e is provided on the surface 2132 along the circumferential direction of the spreading portion 211, and at least one ring of connected or spaced ring shapes is provided on the positioning surface 2172 of the second positioning portion 217 along the circumferential direction of the spreading portion 211
  • the electrode 210e, the ring electrode is an external electrode.
  • the ablation element 210e on the positioning surface 2132 of the first positioning portion 213a is a continuous ring electrode, and the radial distance between the ring electrode and the spreading portion 211 can be set to 0-5 mm, preferably 3 mm .
  • the ablation element 210e on the positioning surface 2172 of the second positioning portion 217 is a continuous ring-shaped electrode.
  • the radial distance between the ring-shaped electrode and the spreading portion 211 can be set to 0-5 mm, preferably 3 mm.
  • Each ring-shaped electrode is a metal wire or sheet with high elasticity and flexibility, such as a nickel-titanium multi-strand wire or a gold-spring-coated nickel-titanium multi-strand wire.
  • Each ablation member 210e is sutured or glued to the support frame 21a with a suture.
  • An insulating film 27 is provided between the outer wall surface of the first positioning portion 213a and the corresponding ablation element 210e; an insulating film 27 is also provided between the outer wall surface of the second positioning portion 217 and the corresponding ablation element 210e.
  • the insulating film 27 on the outer wall surface of the first positioning portion 213a covers the outer wall surface of the positioning surface 2132 and extends to the first thrombus catching cage 2133; the insulating film on the outer wall surface of the second positioning portion 217 27 covers the outer wall surface of the positioning surface 2172 for one week, and extends onto the second thrombus catching cage 2173.
  • the ablation member 210e and the support skeleton 21a can be isolated, and not only the heat conduction between the ablation member 210e and the support skeleton 21a can be isolated, preventing energy from being transferred to the support skeleton 21a, thereby concentrating energy on the ablation member 210e,
  • the insulating film 27 can An insulating barrier is formed on the side to reduce the current density through the blood, reduce the heating of the blood by the current, and reduce the risk of thrombosis.
  • the interatrial septostomy system When using the interatrial septostomy system in this embodiment, it needs to be used in conjunction with a loader, a sheath tube, a sheath core, a conductive pusher, a radio frequency power supply and a power connection line, and a neutral electrode plate.
  • a loader When using the interatrial septostomy system in this embodiment, it needs to be used in conjunction with a loader, a sheath tube, a sheath core, a conductive pusher, a radio frequency power supply and a power connection line, and a neutral electrode plate.
  • the outer wall surface of the spreading portion 211 may also be covered with an insulating film, and the insulating films on the spreading portion 211, the first positioning portion 213a, and the second positioning portion 217 may be manufactured as an integrated structure.
  • FIG. 21 is a schematic structural view of the interatrial septal ostomy system provided in the ninth embodiment of the present application
  • FIG. 22 is a structure of the insulating film removal device of the atrial septal ostomy system in FIG. 21.
  • FIG. 23 is a cross-sectional view taken along line XXIII-XXIII in FIG. 21;
  • FIG. 24 is an enlarged view of the XXIV part in FIG.
  • the structure of the interatrial septal ostomy system provided in the ninth embodiment of the present application is similar to the structure of the sixth embodiment, except that in the ninth embodiment, in the state in which the interatrial septal ostomy device 20h is completely released, it is supported
  • the skeleton 21b includes a recessed curved surface expansion portion 211, a first positioning portion 213b provided at one end of the expansion portion 211, and a second positioning portion 217a provided at the opposite end of the expansion portion 211.
  • the proximal end of the first positioning portion 213b is connected to the spreading portion 211, and the distal end radially extends; the proximal end of the second positioning portion 217a is connected to the spreading portion 211, and the distal end extends axially And converge.
  • the support skeleton 21b is a braided mesh nickel-titanium alloy stent
  • the first positioning portion 213b is a single-layer braided mesh structure.
  • the diameter of the support skeleton 21b may shrink To a smaller state for delivery in the sheath; when released in the heart, it can automatically expand to the desired shape and size, and the expansion portion 211 can produce a certain radial support effect on the perforated inner wall tissue of the interatrial septum in contact with it , And can open the perforation of the interatrial septum to form a stoma;
  • the first positioning portion 213b is attached to the surface of the interatrial septum facing the left atrium, and the second positioning portion 217a is located in the right atrium and is attached to the atrium
  • the septum faces away from the surface of the left atrium, thereby positioning the spreader 211 within the stoma of the atrial septum.
  • the first positioning portion 213a includes a conical or circular positioning surface 2132 formed radially extending from the end edge of the spreading portion 211, and a curved frame 2134 bent distally from the outer edge of the positioning surface 2132
  • the curved frame 2134 is smoothly curved toward the distal end to avoid damage to the atrial tissue.
  • the second positioning portion 217a includes a conical or circular positioning surface 2172 that extends radially outward from the end edge of the spreading portion 211, and is connected to the outer edge of the positioning surface 2172 and A conical second thrombus catching cage 2173 extending toward an end away from the spreading portion 211.
  • the distal end of the second thrombus catching cage 2173 is closed to converge on a cone tip 2176.
  • the cone tip 2176 is used to connect the proximal end of the pushing member 52a.
  • This embodiment includes an ablation element 210e provided on the positioning surface 2172 of the second positioning portion 217a, and an ablation element 210f provided on the positioning surface 2132 of the first positioning portion 213a.
  • the ablation member 210e is a ring electrode connected or spaced at least one circle along the circumferential direction of the spreading portion 211, and the ring electrode is an external electrode.
  • the ablation member 210e is a continuous ring electrode, and the radial distance between the ring electrode and the spreading portion 211 can be set to 0-5 mm, preferably 3 mm.
  • the ablation member 210e is a highly flexible, flexible metal wire or metal sheet, such as a nickel-titanium multi-strand wire, or a gold-spring-coated nickel-titanium multi-strand wire.
  • the ablation member 210e is stitched or glued to the positioning surface 2172 of the second positioning portion 217a by a suture.
  • the ablation member 210f is a partially electrically exposed wire on the positioning surface 2132 of the first positioning portion 213a, and part of the electrically exposed region directly serves as an electrode, that is, the metal wire supporting the skeleton 21b corresponds to the ablation member 210f on the positioning surface 2132
  • the area of is not coated with an insulating coating, and the area of the electrically exposed metal wire on the positioning surface 2132 is connected or spaced at least one turn along the circumferential direction of the spreading portion 211.
  • the ablation member 210f is a bare metal wire material connected in a circle along the circumferential direction of the expansion portion 211, and the radial distance between the ablation element 210f and the expansion portion 211 can be set to 0-5 mm, preferably Set 3mm.
  • the bare metal wire may be selected from memory alloys or stainless steel, preferably memory alloys, preferably nickel titanium alloys.
  • the ablation element 210e and the positioning surface 2172 of the second positioning portion 217a are insulated from each other.
  • the outer surface of the support frame 21a that is in contact with tissue or blood at least outside the area corresponding to the ablation element 210f There is an insulating coating, that is, all surfaces except the ablation member 210f are coated with an insulating coating, such as a parylene insulating coating, so that the ablation member 210e and the support frame 21a are insulated from each other.
  • the outer wall surface of the second positioning portion 217a is entirely covered with an insulating film 27 that insulates the ablation member 210e from the support frame 21b.
  • the side of the first positioning portion 213a facing away from the spreading portion 211 is coated with an insulating coating corresponding to the ablation member 210f, and the insulating coating may be, but not limited to, parylene coating, polytetrafluoroethylene Coating, polyurethane coating, or polyimide coating.
  • the insulating film 27 By using the insulating film 27, the ablation member 210e and the support frame 21b can be isolated.
  • the inner and outer surfaces of the first positioning portion 213a except for the ablation member 210f are coated with an insulating material to isolate the ablation member 210f from the support frame 21b, not only the ablation member
  • the heat conduction between 210e, 210f and the support skeleton 21b prevents the energy from being transferred to the support skeleton 21b, thereby concentrating the energy on the ablation members 210e, 210f to face the surface of the interatrial septum facing the left atrium and the tissue near the stoma And the surface facing away from the left atrium is ablated in the tissue near the stoma to improve energy utilization; and the insulating film 27 and insulating coating can form an insulating barrier on the side of the electrode facing the blood, reducing the current density through the blood, Reduce the current heating of blood, reduce the risk of thrombosis.
  • an insulating sleeve is sleeved on the outer surface of the first positioning portion 213a except for the ablation member 210f.
  • the side of the first positioning portion 213a facing away from the spreading portion 211 is provided with an insulating film corresponding to the region of the ablation member 210f, and the insulating film is stitched or glued to the support frame by stitches on.
  • the ablation element 210e is electrically connected to the radio frequency power supply through a wire 521, and the outer surface of the wire 521 is insulated. Specifically, one end of the wire 521 is connected to the ablation member 210e by welding, and the other end of the wire 521 is connected to the radio frequency power source through the second positioning portion 217a, the cone top 2176, the pushing member 52a, and the connector 562.
  • the ablation member 210f is electrically connected to the RF power source through another wire 521.
  • one end of the other wire 521 is welded to the cone top 2176 of the support frame 21b, so that the support frame 21b is electrically connected to the wire 521, and the other of the wire One end is connected to the radio frequency power supply via the pusher 52a and the connector 562.
  • the polarity selection of the ablation elements 210e and 210f in this embodiment includes but is not limited to the following three schemes:
  • Both the ablation member 210e and the ablation member 210f are connected to the same radio frequency output port through a wire 521, and the neutral electrode plate is connected to the radio frequency power supply circuit end.
  • the ablation member 210e is connected to the RF output port through the wire 521, and the ablation member 210f is connected to the RF power supply circuit end through the wire 521, without a neutral electrode plate.
  • the ablation member 210f is connected to the radio frequency output port through the wire 521, and the ablation member 210e is connected to the radio frequency power supply circuit end through the wire, without a neutral electrode plate.
  • the interatrial septostomy system When using the interatrial septostomy system in this embodiment, it needs to be used in conjunction with a loader, a sheath tube, a sheath core, a conductive pusher, a radio frequency power supply and a power connection line, and a neutral electrode plate.
  • a loader When using the interatrial septostomy system in this embodiment, it needs to be used in conjunction with a loader, a sheath tube, a sheath core, a conductive pusher, a radio frequency power supply and a power connection line, and a neutral electrode plate.
  • FIG. 25 is a schematic structural view of the interatrial septal ostomy system provided in the tenth embodiment of the present application
  • FIG. 26 is a structure of the ablation sealing device of FIG. 25 to remove the insulating film. schematic diagram.
  • the structure of the interatrial septal ostomy system provided in the tenth embodiment of the present application is similar to the structure of the sixth embodiment, except that: in a state where the interatrial septal ostomy device 20i is completely released, the support skeleton 21c includes a cylinder The shape of the expansion portion 211, a first positioning portion 213c provided at one end of the expansion portion 211, and a second positioning portion 217b provided at the opposite end of the expansion portion 211; the first positioning portion 213c The proximal end of is connected to the spreading portion 211, and the distal end extends axially and merges; the proximal end of the second positioning portion 217 is connected to the spreading portion 211, and the distal end extends axially and merges.
  • the first positioning portion 213c and the second positioning portion 217b are both double-layer woven mesh structures.
  • the support frame 21c is a braided mesh nickel-titanium alloy stent.
  • the diameter of the support frame 21c can be contracted to a smaller state for delivery in the sheath; when When released in the heart, it can automatically expand to the desired shape and size, and the expansion portion 211 can produce a certain radial support effect on the perforated inner wall tissue of the perforation of the interatrial septum in contact with it, and can expand the perforation of the atrial septum to Forming a stoma;
  • the first positioning portion 213c is located in the left atrium and fits to the surface of the interatrial septum facing the left atrium, and the second positioning portion 217b is located in the right atrium and fits to the atrial septum facing away from the left atrium The surface, thereby positioning the spreader 211 within the stoma of the interatrial septum.
  • the first positioning portion 213c includes a positioning surface 2132 extending radially outward from the end of the spreading portion 211, and connected to the outer edge of the positioning surface 2132.
  • the conical first thrombus catching cage 2133 extends toward the end away from the spreading portion 211.
  • the positioning surface 2132 may be a planar or nearly planar conical surface or a curved surface, and the outer surface of the first thrombus catching cage 2133 does not abut against the interatrial septum.
  • the distal end of the first thrombosis cage 2133 converges on an apex 2136, which is used for the apex 2136 to smoothly pass through the perforation in the interatrial septum when implanting the atrial septostomy device 20 .
  • the second positioning portion 217b includes a positioning surface 2172 extending radially outward from an end of the spreading portion 211, and connected to the outer edge of the positioning surface 2172 and facing away from the spreading A conical second thrombus catching cage 2173 extending at one end of the portion 211.
  • the positioning surface 2172 may be a planar or nearly planar tapered surface or a curved surface.
  • the outer surface of the second positioning portion 217b does not abut against the interatrial septum.
  • the distal end of the second thrombus catching cage 2173 is closed and merged on a cone tip 2176, and the cone tip 2176 is used to connect the proximal end of the pushing member 52a.
  • three ablation elements are provided, which are an ablation element 210e provided on the outer wall surface of the expansion portion 211, and an ablation element 210f provided on the positioning surface 2132 of the first positioning portion 213c. And an ablation element 210f provided on the positioning surface 2172 of the second positioning portion 217b.
  • the ablation member 210e on the spreading part 211 is a ring electrode connected or spaced at least one circle along the circumferential direction of the spreading part 211, the ring electrode is an external electrode, specifically, the spreading part 211
  • the ablation member 210e on the top is a continuous ring of ring electrodes.
  • the ring electrode is a metal wire or sheet with high elasticity and flexibility, such as a nickel-titanium multi-strand wire or a gold-spring-coated nickel-titanium multi-strand wire. structure.
  • the ablation member 210e is sutured or glued to the support frame 21a by sutures.
  • the ablation element 210f on the positioning surface 2132 of the first positioning portion 213c is a part of the electrically exposed metal wire on the positioning surface 2132 of the support frame 21c, that is, the metal wire material supporting the frame 21c is provided as the ablation element 210f No insulating coating is applied on the area, and part of the electrically exposed metal wire material directly serves as the electrode of the ablation member 210f.
  • the exposed metal wire regions on the positioning surface 2132 are connected or spaced at least one turn along the circumferential direction of the spreading portion 211.
  • the ablation element 210f on the first positioning portion 213c is circumferentially connected along the expansion portion 211, and the radial distance between the ablation element 210f and the expansion portion 211 can be set to 0-5 mm. It is preferably set to 3 mm.
  • the ablation member 210f on the positioning surface 2172 of the second positioning portion 217b is a partially exposed metal wire on the positioning surface 2172 of the supporting frame 21c, that is, the metal wire supporting the frame 21c is provided with ablation on the positioning surface 2172 An insulating coating is not applied on the area of the piece 210f, and the bare metal wire area on the positioning surface 2172 is connected or spaced at least one turn along the circumferential direction of the spreading portion 211.
  • the ablation element 210f on the second positioning portion 217b is circumferentially connected along the expansion portion 211, and the radial distance between the ablation element 210f and the expansion portion 211 can be set to 0-5 mm. It is preferably set to 3 mm.
  • the bare metal wire may be selected from memory alloys or stainless steel, preferably memory alloys, preferably nickel titanium alloys.
  • the ablation member 210e and the spreading portion 211 are insulated from each other. Specifically, all the inner and outer surfaces of the supporting framework 21c except the ablation member 210f are plated with Parylene insulating coating, so that the ablation members 210e, 210f and the supporting framework 21a are insulated from each other. Further, an insulating film 27 is provided between the spreading portion 211 and the ablation member 210e, that is, the insulating film 27 covers the outer wall surface of the spreading portion 211 all around, so that the insulating film 27 insulates the ablation member 210e from the support frame 21c .
  • the inner and outer surfaces of the first positioning portion 213c and the second positioning portion 217b are coated with an insulating coating except for the area of the ablation member 210f, and the insulating coating may be, but not limited to, parylene coating, PTFE Vinyl coating, polyurethane coating, or polyimide coating.
  • the insulating film 27 and the insulating coating the ablation members 210e, 210f and the support skeleton 21b can be isolated, not only can the heat conduction between the ablation members 210e, 210f and the support skeleton 21c be isolated, and the energy can be prevented from being transferred to the support skeleton 21c.
  • the ablation members 210e, 210f to the internal surface of the stoma of the atrial septum, the surface of the atrial septum facing the left atrium near the stoma tissue and the surface of the atrial septum facing away from the left atrium near the stoma All tissues are ablated to improve energy utilization; and the insulating film 27 and insulating coating can form an insulating barrier on the side of the electrode facing the blood, reduce the current density through the blood, reduce the heating of the blood by the current, and reduce the thrombus shape At risk.
  • the ablation element 210e is electrically connected to the radio frequency power supply through a wire 521, and the outer surface of the wire 521 is insulated. Specifically, one end of the lead wire 521 is connected to the corresponding ablation member 210e by welding, and the other end of the lead wire 521 is connected to the radio frequency power supply via the second thrombosis catching cage 2173, the cone top 2176, the pushing member 52a, and the connector 562 .
  • the two ablation pieces 210f are electrically connected to the radio frequency power source through another wire 521. Specifically, one end of the other wire 521 is welded to the cone top 2176 of the support frame 21c, so that the support frame 21c is electrically connected to the wire 521. The other end of the wire is connected to the radio frequency power supply via the pusher 52.
  • the polarity selection of the ablation member 210e on the spreading portion 211 and the second positioning portion 217b and the ablation member 210f on the first positioning portion 213c includes but is not limited to the following three schemes:
  • the ablation element 210e on the spreading portion 211 and the ablation element 210f on the second positioning portion 217b and the first positioning portion 213c are all connected to the same RF output port via a wire 521, and the neutral electrode plate is connected to the RF power circuit end.
  • the ablation member 210e on the spreading part 211 is connected to the RF output port through the wire 521, and the ablation member 210f on the second positioning part 217b and the first positioning part 213c is connected to the RF power supply circuit end through the wire 521 without a neutral electrode plate.
  • the ablation element 210f on the second positioning portion 217b and the first positioning portion 213c is connected to the RF output port through the wire 521, and the ablation element 210e on the expansion portion 211 is connected to the RF power supply circuit end through the wire without a neutral electrode plate.
  • the interatrial septostomy system When using the interatrial septostomy system in this embodiment, it needs to be used in conjunction with a loader, a sheath tube, a sheath core, a conductive pusher, a radio frequency power supply and a power connection line, and a neutral electrode plate.
  • a loader When using the interatrial septostomy system in this embodiment, it needs to be used in conjunction with a loader, a sheath tube, a sheath core, a conductive pusher, a radio frequency power supply and a power connection line, and a neutral electrode plate.
  • FIG. 27 is a schematic structural diagram of an interatrial septostomy system provided in an eleventh embodiment of the present application.
  • the structure of the atrial septal ostomy system provided in the eleventh embodiment of the present application is similar to that of the sixth embodiment, except that in the eleventh embodiment, three ablation members 210e are provided, one of which is At least one ring of connected or spaced ring electrodes is provided along the circumferential direction of the spreading portion 211; another ablation member 210e is provided on the positioning surface 2132 of the first positioning portion 213a and is provided along the circumferential direction of the spreading portion 211 At least one ring of connected or spaced ring electrodes; there is also an ablation member 210e provided on the positioning surface 2172 of the second positioning portion 217 and at least one ring of connected or spaced ring along the circumferential direction of the spreading portion 211 electrode.
  • the ablation element 210e on the spreading portion 211 is a continuous ring electrode; the ablation elements 210e on the positioning surfaces 2132, 2172 of the first positioning portion 213a and the second positioning portion 217 are continuous one
  • the ring-shaped ring electrode, the radial distance between the ring electrode and the spreading portion 211 may be set to 0-5 mm, preferably 3 mm.
  • Each ring-shaped electrode is a metal wire or sheet with high elasticity and flexibility, such as a nickel-titanium multi-strand wire or a gold-spring-coated nickel-titanium multi-strand wire.
  • Each ablation member 210e is sutured or glued to the support frame 21a with a suture.
  • Each ablation member 210e and the support frame 21a are insulated from each other.
  • the outer surface of the support frame 21a is coated with Parylene insulating coating, so that the ablation member 210e and the support frame 21a are insulated from each other.
  • an insulating film 27 is provided between the outer wall surface of the spreading portion 211 and the corresponding ablation element 210e, and an insulating film 27 is also provided between the outer wall surface of the first positioning portion 213a and the corresponding ablation element 210e, and An insulating film 27 is also provided between the outer wall surface of the second positioning portion 217 and the corresponding ablation tool 210e.
  • the insulating film 27 on the spreading portion 211 covers the outer wall surface of the spreading portion 211 around; the insulating film 27 on the outer wall surface of the first positioning portion 213a covers the positioning surface 2132 of the second positioning portion 213a, And extends to the first thrombus catching cage 2133; the insulating film 27 on the outer wall surface of the second positioning portion 217 covers the positioning surface 2172 of the second positioning portion 217, and extends to the second thrombus catching cage 2173.
  • the three insulating films 27 may be three separate insulating films or may be combined into one insulating film.
  • the three ablation members 210e and the support skeleton 21a can be isolated, which not only isolates the heat conduction between the ablation member 210e and the support skeleton 21a, prevents energy from being transferred to the support skeleton 21a, and thus concentrates the energy on the ablation member 210e
  • Each ablation element 210e is electrically connected to a radio frequency power source through a wire 521, and the outer surface of the wire 521 is insulated. Specifically, one end of each wire 521 is connected to the corresponding ablation member 210e by welding, and the other end of the wire 521 is connected to the radio frequency power supply via the support frame 21a and the pushing member 52a.
  • the polarity selection of the three ablation members 210e on the support frame 21a includes but is not limited to the following six schemes:
  • the ablation element 210e on the spreading portion 211, the ablation element 210e of the first positioning portion 213a, and the ablation element 210e of the second positioning portion 217 are all connected to the same RF output port, and the neutral electrode plate is connected to the RF power supply circuit end.
  • the ablation element 210e of the second positioning portion 217 and the ablation element 210e of the first positioning portion 213a are connected to the RF output port, and the ablation element 210e on the expansion portion 211 is connected to the end of the RF power supply circuit without a neutral electrode plate.
  • the ablation element 210e on the spreading portion 211 is connected to the RF output port, the ablation element 210e of the second positioning portion 217 and the ablation element 210e of the first positioning portion 213a are connected to the RF power circuit end, and there is no neutral electrode plate.
  • the ablation element 210e of the second positioning portion 217 and the ablation element 210e on the spreading portion 211 are connected to the RF output port, and the ablation element 210e of the first positioning portion 213a is connected to the RF power circuit end without a neutral electrode plate.
  • the ablation element 210e of the second positioning portion 217, the ablation element 210e of the first positioning portion 213a, and the ablation element 210e on the expansion portion 211 are connected to the three-phase voltage source A-phase, B-phase, and C-phase output ports, respectively.
  • the port outputs three sinusoidal alternating currents of equal amplitude, same frequency, and phase angle that are sequentially different by 120 °, and the neutral electrode plate is connected to the RF power supply circuit end.
  • the ablation element 210e of the second positioning portion 217, the ablation element 210e of the first positioning portion 213a, and the ablation element 210e on the expansion portion 211 are connected to the three-phase voltage source A-phase, B-phase, and C-phase output ports, respectively
  • the port outputs three sinusoidal alternating currents of equal amplitude, same frequency, and phase angle that sequentially differ by 120 ° without a neutral electrode plate.
  • the interatrial septostomy system When using the interatrial septostomy system in this embodiment, it needs to be used in conjunction with a loader, a sheath tube, a sheath core, a conductive pusher, a radio frequency power supply and a power connection line, and a neutral electrode plate.
  • a loader When using the interatrial septostomy system in this embodiment, it needs to be used in conjunction with a loader, a sheath tube, a sheath core, a conductive pusher, a radio frequency power supply and a power connection line, and a neutral electrode plate.

Abstract

一种改进消融效果的房间隔造口系统(100)，包括房间隔造口装置(20,20a,20b, 20c, 20d,20e,20f,20g,20h,20i)、控制房间隔造口装置(20,20a,20b,20c,20d,20e, 20f,20g,20h,20i)的造口装置控制机构(50)及射频电源，射频电源通过造口装置控制机构(50)与房间隔造口装置(20,20a,20b,20c,20d,20e,20f,20g,20h,20i)的消融件(210,210a,210b,210c,210d,210e,210f)电连接，房间隔造口装置(20,20a,20b,20c, 20d,20e,20f,20g,20h,20i)包括用于撑开房间隔(601)上的穿孔的支撑骨架(21,21a, 21b,21c)，支撑骨架(21,21a,21b,21c)上设置有至少一消融件(210,210a,210b, 210c, 210d,210e,210f)，消融件(210,210a,210b,210c,210d,210e,210f)接触房间隔(601)并用于对房间隔(601)进行消融，房间隔造口装置(20,20a,20b,20c,20d,20e,20f,20g, 20h,20i)上除消融件(210,210a,210b,210c,210d,210e,210f)外不能对血液或组织进行消融。一种房间隔造口系统(100)的房间隔造口装置(20,20a,20b,20c,20d,20e, 20f,20g,20h,20i)。

Description

改进消融效果的房间隔造口装置及房间隔造口系统 技术领域
本申请涉及介入医疗器械技术领域，尤其涉及一种经皮介入的改进消融效果的房间隔造口装置，以及设置有所述房间隔造口装置的房间隔造口系统。
背景技术
心力衰竭(简称心衰)，是由于任何心脏结构或功能异常导致心室充盈或射血能力受损的一组复杂临床综合征，其主要临床表现为呼吸困难和乏力(活动耐量受限)，以及液体潴留(肺淤血和外周水肿)。心衰为各种心脏疾病的严重和终末阶段，发病率高，是当今最重要的心血管病之一。根据心力衰竭发生的部位可分为左心、右心和全心衰竭。
心衰是一种发生率和致死率高的严重疾病。我国心衰发病率为2-3％，心衰患病人数在1200万以上。心衰的病因主要有高血压，冠心病，心肌梗死，心脏瓣膜疾病，房颤，心肌病等。心血管疾病造成左心室损伤，导致左心室病理性重构，造成心功能减退。每次成功治疗一位心肌梗死的病人，就带来一位潜在的心衰病人。
在治疗上，优化药物治疗后，患者症状仍反复发作，且目前药物治疗几乎只对射血分数降低的患者有较好的疗效，对射血分数保留的患者疗效并不理想。心脏再同步化治疗并非适合所有的心衰患者，超过20％的患者对于心脏再同步起搏无效。左心室辅助装置手术需体外循环创伤大并发症发生率高，价格昂贵难以获得。心脏移植是最终的解决方案，但是供体的来源非常有限，且价格昂贵。
另一方面，肺动脉高压是以肺动脉系统循环阻力进行性增加为特征的一组疾病，其病理变化包括肺血管收缩与重构、肺血管平滑肌和内皮细胞的异常增殖、原位血栓形成等，最终导致右心功能衰竭而死亡。目前，随着对肺动脉高压发病机制的研究越来越深入，其治疗方法也越来越多。肺动脉高压的治疗方案应是具备个体化及系统化特征的，绝非单一药物可以治疗的，其治疗方式包括：一般治疗、非特异性药物治疗、靶向药物治疗、NO吸入治疗、基因治疗、介入与手术治疗。肺动脉高压患者疾病后期，经上述综合治疗后效果往往不明显、存活率低、预后极差，这时可试行房间隔造瘘术、肺移植、心肺联合移植等外科治疗方法，从而挽救患者生命，但该类治疗方法存在手术风险大、供体缺乏、移植排斥反应、后续治疗费用高等诸多因素。
房间隔造口术是在患者房间隔处造口，从而形成左右心房间的分流，可用于治疗肺动脉高压(右向左分流)或左心衰(左向右分流)，并在临床上证明了有效性。
传统的房间隔造口方法，如球囊房隔造口术，在造口后有心肌组织有回弹的趋势，并在一段时间以后造口会缩小甚至完全闭合。为了解决造口缩小甚至闭合的问题，现有技术中提供了一种造口支架，可分别公布了一种用于心房分流的植入物，其特点是在经皮房间隔穿刺术后，经皮输送一植入物在房间隔穿刺处植入分流器械，以保持分流开口处通畅。
另外一种造口器械，包括切割装置及抓取装置，器械在对组织进行造口时，抓取装置先对所需要切割的部分组织进行定位并抓取；然后由切割装置的切割部对抓取装置所抓取的部分组织进行切割，切割下来的部分组织被抓取装置带出体外，从而形成造口。
上述技术存在如下缺陷：用于心房分流的植入物，在造口处留下了器械，容易导致血栓形成，或器械脱落，形成栓塞。此外，由于内皮爬覆可导致器械开口被封堵，通道关闭失去分流作用。另外，在手术过程中通过机械或高频电刀对心内组织进行切割，有较高的风险，如在术中抓取装置手术中发生松动或在回收时，可能导致所切割的组织脱落并形成栓塞。此外，如果在切割过程中，抓取装置的松动极易导致其它心肌组织受损。
申请内容
本申请的目的在于提供一种造口不易封堵的、改进消融效果的房间隔造口装置，以及设置有所述房间隔造口装置的房间隔造口系统。
为了解决上述技术问题，本申请提供了一种改进消融效果的房间隔造口装置，其包括用于撑开房间隔上的穿孔的支撑骨架，所述支撑骨架上设置有至少一消融件，所述消融件接触所述房间隔并用于对所述房间隔进行消融，所述装置上除所述消融件外不能对血液或组织进行消融。
本申请还提供一种房间隔造口系统，其包括房间隔造口装置、控制所述房间隔造口装置的造口装置控制机构及射频电源，所述射频电源通过造口装置控制机构与所述房间隔造口装置的消融件电连接， 所述房间隔造口装置包括用于撑开房间隔上的穿孔的支撑骨架，所述支撑骨架上设置有至少一消融件，所述消融件接触所述房间隔并用于对所述房间隔进行消融，所述装置上除所述消融件外不能对血液或组织进行消融。
本申请提供的房间隔造口系统的房间隔造口装置包括撑开房间隔上的穿孔的支撑骨架，以及设置于所述支撑骨架上的消融件，所述消融件用于对所述造口附近的房间隔组织进行消融，且所述装置上除所述消融件外不能对血液或组织进行消融。因此，所述支撑骨架能将房间隔上的穿孔撑开以形成造口，并通过消融件对所述造口四周的房间隔组织进行消融，经所述房间隔造口装置处理后的造口形状较为规则，且不易封堵，能保持造口的通畅，进而使左右心房间的血液分流顺畅。
附图说明
为了更清楚地说明本申请实施例中的技术方案，下面将对实施例中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的明显变形方式。
图1是本申请第一实施例提供的房间隔造口系统的第一种实施方式的结构示意图；
图2是图1中的房间隔造口系统的房间隔造口装置的放大图；
图3是图2中的房间隔造口装置的导线组件的展开示意图；
图4是图3中的导线组件的其中一导线的剖视结构示意图；
图5是图1中V部分的放大示意图。
图6是图5中沿VI-VI线的剖视图；
图7是图5中沿VII-VII线的剖视图；
图8至图11是本申请第一实施例提供的房间隔造口系统的使用操作过程示意图。
图12是本申请第二实施例提供的房间隔造口系统的消融封堵装置的结构示意图；
图13是图12中消融封堵装置的正面部分剖视图；
图14是本申请第三实施例提供的房间隔造口系统的消融封堵装置的结构示意图；
图15是本申请第四实施例提供的房间隔造口系统的消融封堵装置的结构示意图；
图16是本申请第五实施例提供的房间隔造口系统的消融封堵装置的结构示意图；
图17是本申请第六实施例提供的房间隔造口系统的结构示意图；
图18是图17中的房间隔造口系统的消融封堵装置去除绝缘膜的结构示意图；
图19是本申请第七实施例提供的房间隔造口系统的结构示意图；
图20是本申请第八实施例提供的房间隔造口系统的结构示意图；
图21是本申请第九实施例提供的房间隔造口系统的结构示意图；
图22是图21中的房间隔造口系统的消融封堵装置去除绝缘膜的结构示意图；
图23是图21中沿XXIII-XXIII线的剖视图；
图24是图23中XXIV部分的放大图；
图25是本申请第十实施例提供的房间隔造口系统的结构示意图；
图26是图25中的房间隔造口系统的消融封堵装置去除绝缘膜的结构示意图；
图27是本申请第十一实施例提供的房间隔造口系统的结构示意图。
具体实施方式
下面将结合本申请实施例中的附图，对本申请实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本申请一部分实施例，而不是全部的实施例。基于本申请中的实施例，本领域普通技术人员在没有付出创造性劳动前提下所获得的所有其它实施例，都属于本申请保护的范围。
为了更加清楚地描述止血阀、鞘管及导管鞘组件的结构，本申请所述的限定术语“近端”及“远端”为介入医疗领域惯用术语。具体而言，“远端”表示手术操作过程中远离操作人员的一端，“近端”表示手术操作过程中靠近操作人员的一端。除非另有定义，本申请所使用的所有的技术和科学术语与属于本申请的技术领域的技术人员通常理解的含义相同。本申请在说明书中所使用的惯用术语只是为了描述具体实施例的目的，并不能理解为对本申请的限制。
请参阅图1及图2，图1是本申请第一实施例提供的房间隔造口系统的第一种实施方式的结构示意图；图2是图1中的房间隔造口系统的房间隔造口装置的放大图。本申请提供一种房间隔造口系统100，其包括一房间隔造口装置20及用于控制所述房间隔造口装置20的造口装置控制机构50。所述房间隔造 口装置20包括用于撑开房间隔上的穿孔的一支撑骨架21，以撑开所述穿孔形成造口。所述支撑骨架21上设置有至少一消融件210，所述消融件210接触邻近所述房间隔上的穿孔附近的房间隔组织，并用于对所述房间隔组织进行消融，即所述房间隔造口装置20上除所述消融件210外不能对血液或组织进行消融。
本实施例中，所述消融件210包括用于消融的至少一电极，至少一所述电极可以是外部电极，也可以是直接设置于支撑骨架21上的电极，至少一所述电极电性连接于射频电源，至少一所述电极接收所述射频电源的能量用于对所述造口四周的房间隔组织进行消融。
本申请的房间隔造口系统100的房间隔造口装置20包括撑开房间隔上的穿孔的支撑骨架21，以及设置于所述支撑骨架21上的消融件210，所述消融件210用于对所述造口四周的房间隔组织进行消融，且所述支撑骨架21上至少在消融件210接触区域的外表面进行绝缘处理。因此，所述支撑骨架21能将房间隔上的穿孔撑开以形成造口，并通过消融件210对所述造口四周的房间隔组织进行消融，因此，经所述房间隔造口装置20处理后的造口形状较为规则，且不易封堵，能保持造口的通畅，进而使左右心房间的血液分流顺畅。
所述支撑骨架21与所述消融件210之间设置有绝缘膜27，所述绝缘膜27可以是但不限于聚四氟乙烯薄膜、聚氨酯薄膜、或聚酰亚胺薄膜等。由于所述支撑骨架21与所述消融件210之间通过绝缘膜27进行隔离，因此，所述绝缘膜27不仅能隔绝消融件210与支撑骨架21之间的热量传导，即防止能量传递至支撑骨架21上，从而能将热量集中在消融件210上以对房间隔组织进行消融，提高能量利用率；并且所述绝缘膜27还可以在消融件210面向血液的一侧形成绝缘屏障，从而减小通过血液的电流密度，减小消融件210对血液的加热，降低血栓形在的风险。
本实施例中，所述绝缘膜27设置于所述支撑骨架21对应所述消融件210的外壁面上。具体的，所述绝缘膜27通过缝线缝合或胶粘的方式连接于所述支撑骨架21的外壁面上。
在其他实施例中，所述绝缘膜27也可以设置于所述消融件210对应所述支撑骨架21的表面，具体的，所述绝缘膜27通过胶粘的方式贴合于所述消融件210面朝所述支撑骨架21的外表面上。
在其他实施例中，所述支撑骨架21对应所述消融件210的表面涂设绝缘涂层，或者所述消融件210对应所述支撑骨架21的表面涂设绝缘涂层，所述绝缘涂层可以是但不限定为派瑞林涂层、聚四氟乙烯涂层、聚氨酯涂层、或聚酰亚胺涂层。由于所述支撑骨架21与所述消融件210之间通过绝缘涂层进行绝缘，从而能使消融件210的能量不易传导至支撑骨架21上，将能量集中在消融件210上以对房间隔进行消融，提高能量利用率。
如图2所示，所述支撑骨架21为自膨胀式造口装置，所述支撑骨架21可以是弹性金属支架或弹性的非金属支架。本实施例中，所述支撑骨架21为镍合金支架，当房间隔造口装置20通过鞘管输送时，所述支撑骨架21的直径可收缩至较小状态以便在鞘管中输送；当所述房间隔造口装置20在心脏内释放时，支撑骨架21可自动膨胀至所需形状尺寸，以使所述支撑骨架21能撑开房间隔上的造口内，即所述支撑骨架21于所述造口中的部分对造口的组织产生径向的支撑作用。
支撑骨架21可以采用镍合金管切割而成，也可以采用镍合金丝编织而成。支撑骨架21的网状结构的疏密程度根据需要设定。本实施例中采用菱形结构单元连续周向排布一圈形成，支撑骨架21整体形状可以是直筒形、盘状、锥形等多种适用形状，在此不作限定。
所述支撑骨架21的外壁面及内壁面上均涂设有绝缘涂层，所述绝缘涂层可以是但不限定于聚四氟乙烯涂层、聚氨酯涂层或聚酰亚胺涂层等。本实施例中，所述支撑骨架21的外壁面及内壁面上均涂设有聚四氟乙烯涂层。
在其他实施例中，所述支撑骨架21的镍合金丝上也可以套设有绝缘套管。
在所述房间隔造口装置20完全释放的状态下，支撑骨架21包括圆柱形的一撑开部211、设置于所述撑开部211一端的一第一定位部213、设置于所述撑开部211背朝所述第一定位部213一端的一延伸部214，以及设置于所述延伸部214远离所述撑开部211一端的一回收部215。所述撑开部211用于撑开所述房间隔上的穿孔以形成造口；所述第一定位部213用于定位所述支撑骨架21至所述房间隔的造口内；所述延伸部214能够避免撑开部211向远端延伸时偏离所述造口，而导致无法扩张该处组织，从而使所述延伸部214能够补偿撑开部211偏离所述造口处而带来的不良影响。
本实施例中，当所述支撑骨架21在完全释放的状态下，所述撑开部211释放后能径向膨胀，从而能均匀撑开房间隔上穿孔，能扩大房间隔上的穿孔以形成造孔。具体的，撑开部211为连续周向排布一圈波形环状结构，所述第一定位部213的近端与所述撑开部211相连接，即第一定位部213与波形环状结构的波峰相连接，所述第一定位部213的远端径向辐射延伸以形成锥形面或圆形面。延伸部214的近端与所述撑开部211相连，即所述延伸部214与所述波形状结构的波谷相连接，所述延伸部214的远端 轴向延伸；回收部215的近端与所述延伸部214相连接，所述回收部215的远端轴向延伸并汇合。
在其他实施例中，撑开部211可以是网状支架、杆状支架、多层的波形支架或它们组合形成的管状结构或环状结构。网状支架具有明显的经纬交错结构，或具有重复的单元格结构，既可以采用编织也可以是切割方式，经纬交错部位既可以相对滑动也可以相互固定；波形支架具有多圈环状的波形结构，包括波峰、波谷和波杆，周向相邻的波杆在近端相连接形成波峰，远端相连接形成波谷；管状结构可理解为轴向上延伸一段距离，例如轴向尺寸大于等于管状结构的外径，相对于管状结构，环状结构的轴向尺寸略小，一般小于环状结构的外径；轴向相邻的两圈波形结构可通过覆膜连接，或者多圈覆膜固定连接于管状覆膜上；杆状支架具有多根轴向延伸的支撑杆，支撑杆合围形成管状结构，支撑杆之间可通过高分子聚合物的覆膜连接，或者支撑杆固定连接于管状覆膜上。
所述撑开部211的形状可以有多种，例如撑开部211可以为外侧壁内凹或/和外凸的曲面形、圆筒形、椭圆筒形或者是它们的组合。曲面形是在周向形成一个封闭的曲面结构，外凸和内凹的位置可以根据需要设定，可以单独形成外凸结构或内凹结构，也可以将外凸或内凹结构相结合设置在同一个撑开部211上。外凸结构如：盘状、球台形等，内凹结构如：腰鼓形，本实施例中采用圆筒形结构，与支撑骨架21的直筒形平滑过渡形成一个整体圆筒结构。撑开部211的轴向长度根据实际需要设定，一般与房间隔的厚度匹配即可。
所述回收部215呈圆锥状，其近端与所述延伸部214相连接，所述回收部215的远端汇至于一连接件2152上，所述连接件2152用于连接造口装置控制机构50。具体的，所述回收部215包括连接于延伸部214与连接件2152之间的若干延伸片2151，及所述连接件2152。所述连接件2152为管状结构，所述管状结构的释放状态的外径小于延伸部214的释放状态的外径。所述连接件2152上沿周向开设有若干固定孔2154，所述固定孔2154用于将连接件2152固定于造口装置控制机构50上。本实施例中，消融件210设置在撑开部211上，具体的，所述消融件210设置于所述撑开部211的外壁面上，所述消融件210与所述撑开部211的外壁面之间设置有所述绝缘膜27，消融件210投影至绝缘膜27上的区域位于绝缘膜27内，即消融件210在绝缘膜27上的投影面积小于或等于绝缘膜27的面积。
本实施例中，所述消融件210为外部电极，具体的，所述消融件210为单极电极，所述单极电极与射频源相连接，配合外加中性电极板使用以对房间隔组织进行消融。所述外部电极是指独立于所述支撑骨架21的电极通过胶粘或缝线缝合等方式连接于所述支撑骨架21上的电极。
请一并参阅图2至图4，所述消融件210包括若干柔性导线2102、设置于每一导线2102近端的消融部2104，以及设置于每一导线2102远端的连接部2105。每一导线2102通过胶粘或缝线缝合至所述支撑骨架21的外壁面上。每一导线2102的消融部2104位于所述撑开部211的外壁面上，这些消融部2104沿所述撑开部211的周向设置至少一圈；每一导线2102的连接部2105轴向延伸出所述连接件2152并电性连接于射频源。
如图4所示，本实施例中，导线2102包括柔性的金属层2106、套设于所述金属层2106外的绝缘层2107，以及胶贴于所述导线2102的绝缘层2107用于将导线2102粘贴于支撑骨架21上的胶粘层2108。所述消融部2104为所述导线2102的近端去除背朝所述胶粘层2108的一侧的绝缘层2107；所述连接部2105为所述导线2102的远端去除绝缘层2107及胶粘层2108。
所述消融部2104与所述撑开部211之间还设置有所述绝缘膜27，具体的，所述绝缘膜27为覆盖于撑开部211的外壁面一周的环状结构，所述绝缘膜27通过缝线缝合于所述撑开部211的外壁面一周，以使消融部2104与所述撑开部211之间进行绝缘处理。
如图1、图5及图6，所述造口装置控制机构50包括推送件52、一外鞘管组件54、及一控制手柄56。所述推送件和房间隔造口装置可设置为可拆卸连接或者一体固定连接，在本实施例中，所述推送件52与房间隔造口装置20为一体固定连接，所述推送件52内设置有导线521，导线521与房间隔造口装置20的连接部2105电连接。
推送件52包括一双腔管520及套设于所述双腔管520近端外壁上的一连接套523。具体的，所述双腔管520的近端外壁面上周向开设有收容口5202，所述连接套523套接于所述双腔管520上并收容于所述收容口5202内，此时，所述连接套523的外表面与所述双腔管520的外表面对齐。所述双腔管520由聚乙烯或其它高分子材料制成，所述双腔管520包括轴向延伸的第一腔体5201及第二腔体2503。所述第一腔体5201用于放置鞘芯，所述第二腔体2503用于收容导线521。推送件52的近端与所述房间隔造口装置20的远端的连接件2152通过机构连接。具体的，所述连接套523是由导电金属制成的管体，所述连接套523的近端套接于所述连接件2152的远端，所述推送件52内的导线521的近端穿过双腔管520的管壁后焊接于所述连接套523上，所述导线521的远端沿第二腔体2503延伸直至连接于射频电源。消融件210的柔性导线2102的连接部2105焊接于连接套523的外壁面上。
所述连接套523及所述连接件2152外还套设有保护管527，所述保护管527由聚四氟乙烯、聚氨酯或聚酰亚胺等绝缘材料制成，所述保护管527的近端套设于所述连接套523及连接件2152的外壁面上，保护管527的远端从推送件52近端向后一直延伸，直到覆盖过连接套523后面一段长度。此时，所述消融件210的每一导线2102的连接部2105位于所述连接套523与所述保护管527之间。所述连接套523处的所有材料也熔合在一起，焊接处完全熔于材料内部，从而保证电性连接的安全可靠。
如图1所示，外鞘管组件54包括具有鞘管腔541的鞘管540，及鞘芯543。所述推送件52位于鞘管腔541内，鞘芯543位于所述推送件52的第一腔体5201内。鞘芯543包括由具有空腔的PEEK管5432，及设置于所述PEEK管5432的前端并与所述鞘管540相匹配的顶头5434。所述PEEK管5432收容于所述推送件52的第一腔体5201内，所述顶头5434在所述房间隔造口装置20插入房间隔的穿孔时具有引导的作用。
推送件52、鞘管540、鞘芯543的后端分别与控制手柄56连接。控制手柄56连接的远端设置有与射频电源连接的接头562。推送件52的导线521远端与接头562电性连接。控制手柄56设置有相互独立的运动机构，可以实现推送件52、鞘管540、鞘芯543相互独立的运动。
请一并参阅图1、图2及图8至图11，本实施例中，房间隔造口装置20、推送件52、鞘芯543、鞘管540和控制手柄56为一套完整的系统，本实施例的房间隔造口系统操作流程如下所示：
采用穿刺机构对房间隔601穿刺，穿刺后，将导丝送入到左上肺静脉605内并撤出穿刺套件；
连接手柄近端的接头562到射频电源(射频电源)，并沿导丝将预装在鞘管540内的房间隔造口装置20推送至体内并使鞘管前端位于左心房606内；
后撤鞘管540使房间隔造口装置20的第一定位部213完全出鞘，第一定位部213完全张开，通过超声或DSC判断第一定位部213是否完全张开。过程中需保证鞘管540远端一直位于左心房内。然后保持器械间无相对运动并向后拉动鞘管540使第一定位部213紧贴在房间隔601面朝所述左心房的表面上；
后撤鞘管540使房间隔造口装置20的撑开部211完全出鞘，通过超声或DSC判断，并将房间隔601撑开一小孔，即在所述房间隔601上形成造口603；
观察并使消融件210与房间隔601的组织接触良好，然后设置加热参数(如功率30W，持续时间120S)，然后启动加热。
加热停止后，向前推送鞘管540，使回收部215及延伸部214收缩至较小尺寸并收入鞘管540中，再向前推送鞘管540使撑开部211及第一定位部213均完全回收至鞘管，并整体后撤。然后通过超声或DSC测量造口603大小是否达到临床需求。
本实施例中的房间隔造口系统100的房间隔造口装置20的撑开部211扩张房间隔上的穿孔而形成造口，所述撑开部211上的消融件210能将所述造口内壁面上的组织进行消隔，从而能防止造口附近的内皮爬覆封堵所述造口，能保持造口的通畅；其次，绝缘膜27能在消融件210与面向血液的一侧形成绝缘屏障，减小通过血液的电流密度，减小电流对血液的加热，降低血栓形在的风险；另外，房间隔造口装置20在完成造口后能进行回收，即所述房间隔造口装置20无需保留在房间隔上，从而避免了器械脱落形成栓塞。
请一并参阅图12及图13，图12是本申请第二实施例提供的房间隔造口系统的消融封堵装置的结构示意图；图13是图12中消融封堵装置的正面部分剖视图。本申请第二实施例提供的消融封堵装置的结构与第一实施例的结构相似，不同之处在于：在第二实施例中，房间隔造口装置20a的支撑骨架21也是自膨胀式的镍合金支架，所述房间隔造口装置20a在完全释放的状态下，其也包括圆筒状的撑开部211、第一定位部213、延伸部214及回收部215，其中第一定位部213位于撑开部211的一端，延伸部214位于撑开部211远离所述第一定位部213的一端。
回收部215的近端连接于延伸部214远离撑开部211的一端，回收部215的远端收缩于连接件2152。所述连接件2152为圆筒状，连接件2152内设置有一定位件2155，所述定位件2155通过胶粘、卡接或螺接于所述连接件2152内。本实施例中，定位件2155为金属导电件，具体的，定位件2155为金属螺母，所述连接件2152的内表面设置有内螺纹，所述定位件2155螺接于所述连接件2152内。所述定位件2155的中部轴向开设有螺孔2157，所述螺孔2157用于连接推送件52。所述定位件2155与所述连接件2152通过绝缘处理。
在其他实施例中，定位件2155可以与连接件2152过盈配合，使所述定位件2155卡接于所述连接件2152内；定位件2155也可以通过胶粘连接于所述连接件2152内。
本实施例中，支撑骨架21上的柔性导线2102的一端电性连接于消融件210a，所述柔性导线2102的另一端电性连接于所述定位件2155。具体的，所述柔性导线2102位于所述支撑骨架21内，所述柔性 导线2102的一端穿过支撑骨架21后焊接于消融件210a，所述柔性导线2102的另一端焊接于定位件2155，所述定位件2155通过推送件52内的导线电性连接于射频电源。
在其他实施例中，所述定位件2155也可以由不导电材料制成，所述定位件2155轴向地开设有穿线孔，支撑骨架21上的柔性导线2102远离消融件210a的一端穿过所述穿线孔后直接电性连接于射频电源。
在撑开部211上开设有若干通孔2112，这些通孔2112沿所述撑开部211的周向排列一圈。所述柔性导线2102的一端穿过其中一通孔2112后电性连接于消融件210a。在其他的通孔2112内设置有显影标志2114，即这些显影标志2114围绕撑开部211一圈，以方便支撑骨架21的植入及定位。显影标志2114通过机械、焊接或粘接的方式设置于对应的通孔2112内。显影标志2114的材料可选择但不限于：金、铂、铂-钨、钯、铂-铱、铑、钽，或这些金属的合金或复合物。
第一定位部213为从连接所述撑开部211的端边的连接点径向辐射出去形成的盘状结构，所述盘状结构的直径大于撑开部211的直径。在本实施例中，所述第一定位部213设置为一圆形单层平面结构，所述圆形单层平面结构可作为固定撑开部211位置的定位结构。当所述撑开部211穿置于房间隔的造口内时，第一定位部213面朝所述撑开部211的外表面与房间隔于造口的外周面抵接，以避免所述撑开部211偏离房间隔的造口位置。
进一步的，所述第一定位部213包括还包括外缘翻翘结构，所述外缘翻翘结构为自第一定位部213的外缘部分向远离撑开部211的一侧圆滑过渡弯曲，避免损伤心房组织。
第一定位部213的平面结构至少部分与房间隔面朝左心房的表面相贴合，所述消融件210a位于第一定位部213与房间隔面朝左心房的表面之间，使所述消融件210a接触所述房间隔面朝左心房的表面。所述消融件210a是沿撑开部211的周向设置至少一圈连接的或间隔的环形电极，所述环形电极是外部电极。本实施例中，所述消融件210a是围绕撑开部211设置一圈的环形电极，所述环形电极与撑开部211的径向距离可设置为0～5mm，优选设置3mm。
具体的，消融件210a为一连续环状的、有较高弹性的、柔软的金属线材。如镍钛多股丝、或黄金弹簧包裹的镍钛多股丝等结构。消融件210a可通过缝线缝合和(或)捆绑附着在第一定位部213上。导线2102的一端焊接于所述环形电极上，另一端电性连接于定位件2155。
支撑骨架21内外表面均涂设有绝缘层，如镀有派瑞林绝缘涂层，从而使消融件210a与支撑骨架21相互绝缘。进一步的，在消融件210a与第一定位部213之间设置有绝缘膜27a。具体的，绝缘膜27a设置为环状结构，绝缘膜27a包括覆盖于第一定位部213邻近撑开部211处一周的第一环状绝缘膜271，以及覆盖于撑开部211邻近第一定位部213处一周的第二环状绝缘膜273。通过使用绝缘膜27a能隔绝消融件210a和第一定位部213，不仅可以隔绝第一定位部213与支撑骨架21之间的热量传导，防止能量传递至支撑骨架21上，从而将能量集中在消融件210a上，以对房间隔面朝左心房的表面于造口四周的组织进行消融，提高能量利用率；并且绝缘膜27a能在消融件210a面向血液的一侧形成绝缘屏障，减小通过血液的电流密度，减小电流对血液的加热，降低血栓形在的风险。
在其他实施例中，绝缘膜27a也可以仅包括覆盖于第一定位部213邻近撑开部211处一周的第一环状绝缘膜271，即绝缘膜27a可以省略第二环状绝缘膜273。所述第一环状绝缘膜271用于隔绝消融件210a和第一定位部213。
将定位件2155连接于推送件，即推送件的近端可以通过螺接于定位件2155，即定位件2155通过定位件2155的螺孔2157连接于推送件上。所述推送件内的导线电性连接于定位件2155，从而使消融件210a通过柔性导线2102、定位件2155及推送件内的导线电性连接于射频电源。
本实施例中的房间隔造口系统在使用时，需与装载器、鞘管、鞘芯、可导电的推送器、射频电源及电源联接线、中性电极板等联合使用。具体的使用流程及方法与第一实施例相同，在此不再赘述。
本实施例中的房间隔造口系统的房间隔造口装置20a的撑开部211能扩张房间隔上的穿孔而形成造口，所述第一定位部213上的消融件210a能将所述房间隔于造口四周的组织进行消隔，从而能防止造口附近的内皮爬覆封堵所述造口，防止造口封堵，能保持造口的通畅；其次，所述绝缘膜27还可以在消融件210a面朝血液的一侧形成绝缘屏障，从而减小通过血液的电流密度，减小消融件210a对血液的加热，降低血栓形在的风险另外；另外，房间隔造口装置20a在完成造口后能进行回收，即所述房间隔造口装置20a无需保留在房间隔上，从而避免了器械脱落形成栓塞。
在其他实施例中，消融件210a可以是围绕撑开部211设置于所述撑开部211的外壁面上的至少一圈的环形电极，所述消融件210a与所述撑开部211的外壁面之间设置有绝缘膜27a。
在其他实施例中，消融件210a可以是围绕撑开部211设置于所述撑开部211及所述第一定位部213的外壁面上的至少一圈的波浪型环形电极，即所述波浪型环形电极的一部分位于所述撑开部211的外壁 面上，另一部分位于第一定位部213的外壁面上，所述消融件210a与所述撑开部211及第一定位部213的外壁面之间设置有绝缘膜27a。
请参阅图14，图14是本申请第三实施例提供的房间隔造口系统的消融封堵装置的结构示意图。本申请的第三实施例提供的消融封堵装置的结构与第一实施例的结构相似，不同之处在于：第三实施例中的消融件的结构与第一实施不同，在第三实施例中，消融封堵装置20b的消融件210b包括若干间隔的点状电极，所述点状电极为外部电极，这些点状电极沿支撑骨架21的外壁表面的周向设置至少一圈。具体的，这些点状电极沿撑开部211的外壁表面周向设置一圈，消融件210b与支撑骨架21之间绝缘处理。所述绝缘处理的方式为在与点状电极接触的支撑骨架21的外壁面涂覆绝缘涂层，或者在所述支撑骨架21与点状电极接触的金属丝上穿插绝缘套管，绝缘套管包裹在所述支撑骨架12的金属丝的外壁面，并且在消融件210b与支撑骨架21之间设置有绝缘膜27。所述绝缘涂层或套管材料可选自FEP/ETFE/PFA，所述绝缘膜27可以是但不限于聚四氟乙烯薄膜、聚氨酯薄膜、或聚酰亚胺薄膜等。
这些点状电极是作为消融的电极，这些点状电极通过一根导线串联后电性连接于柔性导线2102，所述柔性导线2102通过所述连接件2152、连接套523、及推送件内设置有导线电性连接于射频电源。
本实施例中的房间隔造口系统在使用时，需与装载器、鞘管、鞘芯、可导电的推送器、射频电源及电源联接线、中性电极板等联合使用。具体的使用流程及方法与第一实施例相同，在此不再赘述。
本实施例中的房间隔造口系统的房间隔造口装置20b的撑开部211将房间隔上的穿孔撑开而形成造口，所述撑开部211上的消融件210b能将所述造口内壁的组织进行消隔，从而能防止造口附近的内皮爬覆封堵所述造口，防止造口封堵，能保持造口的通畅；其次，所述绝缘膜27还可以在消融件210b面朝血液的一侧形成绝缘屏障，从而减小通过血液的电流密度，减小消融件210b对血液的加热，降低血栓形在的风险另外；另外，房间隔造口装置20b在完成造口后能进行回收，即所述房间隔造口装置20b无需保留在房间隔上，从而避免了器械脱落形成栓塞。
在其他实施例中，至少一圈点状电极可以设置于第一定位部213面朝撑开部211的外壁面上，至少一圈点状电极与所述第一定位部213之间设置有绝缘膜27。
请参阅图15，图15是本申请第四实施例提供的房间隔造口系统的消融封堵装置的结构示意图。本申请第四实施例提供的消融封堵装置的结构与第一实施例的结构相似，不同之处在于：第四实施例中的消融件的结构与第一实施不同，在第四实施例中，消融封堵装置20c的消融件210c为设置在支撑骨架21的外壁周向上的单圈间断的环状电极，所述环状电极为外部电极，所述环状电极与支撑骨架21之间绝缘处理。具体的，单圈间断的环状电极设置于撑开部211的外壁面上，所述环状电极与所述撑开部211之间设置有绝缘膜27。环状电极通过一根导线串联后电性连接于导线2102，所述导线2102再与射频电源连接。
本实施例中的房间隔造口系统在使用时，需与装载器、鞘管、鞘芯、可导电的推送器、射频电源及电源联接线、中性电极板等联合使用。具体的使用流程及方法与第一实施例相同，在此不再赘述。
本实施例中的房间隔造口系统的房间隔造口装置20c的撑开部211能将房间隔上的穿孔撑开而形成造口，所述撑开部211上的消融件210c能将所述造口内壁的组织进行消隔，从而能防止造口附近的内皮爬覆封堵所述造口，防止造口封堵，能保持造口的通畅；其次，所述绝缘膜27还可以在消融件210c面朝血液的一侧形成绝缘屏障，从而减小通过血液的电流密度，减小消融件210c对血液的加热，降低血栓形在的风险另外；另外，房间隔造口装置20c在完成造口后能进行回收，即所述房间隔造口装置20c无需保留在房间隔上，从而避免了器械脱落形成栓塞。
在其他实施例中，单圈间断的环状电极可以设置于第一定位部213面朝撑开部211的外壁面上，单圈间断的环状电极与所述第一定位部213之间设置有绝缘膜27。
请参阅图16，图16是本申请第五实施例提供的房间隔造口系统的房间隔造口装置的结构示意图。本申请第五实施例提供的造口系统的结构与第二实施例的结构相似，不同之处在于：第五实施例中的消融件的结构与第二实施不同，在第五实施例中，房间隔造口装置20d的消融件210d包括若干间隔的杆状电极，杆状电极为外部电极，每一杆状电极沿支撑骨架21的轴向延伸，这些杆状电极沿支撑骨架21的外壁面的周向设置至少一圈。具体的，这些杆状电极沿撑开部211的外壁面设置至少一圈，消融件210d与支撑骨架21之间绝缘处理。所述绝缘处理的方式为在与杆状电极接触的支撑骨架21的外壁面涂覆绝缘涂层，或者在所述支撑骨架21与杆状电极接触的金属丝上穿插绝缘套管，绝缘套管包裹在所述支撑骨架21的金属丝的外壁面，并且在消融件210d与支撑骨架21之间设置有绝缘膜27a。所述绝缘涂层或套管材料可选自FEP/ETFE/PFA，所述绝缘膜27可以是聚四氟乙烯薄膜、聚氨酯薄膜、或聚酰亚胺薄膜等。
本实施例中的房间隔造口系统在使用时，需与装载器、鞘管、鞘芯、可导电的推送器、射频电源 及电源联接线、中性电极板等联合使用。具体的使用流程及方法与第二实施例相同，在此不再赘述。
本实施例中的房间隔造口系统的房间隔造口装置20d的撑开部211能将房间隔上的穿孔撑开而形成造口，所述撑开部211上的消融件210d能将所述造口内壁的组织进行消隔，从而能防止造口附近的内皮爬覆封堵所述造口，防止造口封堵，能保持造口的通畅；其次，所述绝缘膜27a还可以在消融件210d面朝血液的一侧形成绝缘屏障，从而减小通过血液的电流密度，减小消融件210d对血液的加热，降低血栓形在的风险另外；另外，房间隔造口装置20d在完成造口后能进行回收，即所述房间隔造口装置20d无需保留在房间隔上，从而避免了器械脱落形成栓塞。
在其他实施例中，至少一圈的杆状电极可以设置于第一定位部213面朝撑开部211的外壁面上，至少一圈的杆状电极与所述第一定位部213之间设置有绝缘膜27a。
请参阅图17及图18，图17是本申请第六实施例提供的房间隔造口系统的结构示意图；图18是图17中的房间隔造口系统去除绝缘膜后的结构示意图。本申请第六实施例提供的房间隔造口系统的结构与第一实施例的结构相似，不同之处在于：在第六实施例中，在所述房间隔造口装置20e完全释放的状态下，所述支撑骨架21a包括圆筒状的撑开部211、设置于所述撑开部211一端的第一定位部213a，以及设置于所述撑开部211相对的另一端的第二定位部217；所述第一定位部213a的近端与所述撑开部211相连，远端轴向延伸并汇合；所述第二定位部217的近端与所述撑开部211相连，远端轴向延伸并汇合。
本实施例中，支撑骨架21a为编织网状的镍钛合金支架，当房间隔造口装置20e通过鞘管输送时，支撑骨架21a的直径可收缩至较小状态以便在鞘管中输送；当在心脏中释放时，可自动膨胀至所需形状尺寸，并且撑开部211能对与其接触的房间隔上的穿孔的内壁组织产生一定的径向支撑作用，并能将所述穿孔撑开以形成造口；所述第一定位部213a位于左心房内且至少部分贴合于房间隔面朝左心房的表面，所述第二定位部217位于右心房内且至少部分贴合于房间隔背朝左心房的表面，从而能将撑开部211定位于房间隔的造口内。
所述第一定位部213a包括自所述撑开部211的端边缘径向辐射延伸以形成平面状或近似平面的锥面或弧面状的一定位面2132，以及连接于所述定位面2132外边缘处并朝向远离所述撑开部211的一端延伸的锥状的第一血栓抓捕笼2133。所述第一血栓抓捕笼2133的远端收口以形成一第一收口面2135，所述第一收口面2135为一圆锥状的锥面，所述第一收口面2135的远端汇合于一顶点2136上。所述第一血栓抓捕笼2133的外表面不与房间隔相贴靠，所述顶点2136用于在植入所述房间隔造口装置20e时顶点2136能顺畅地穿过房间隔上的穿孔。
所述第二定位部217包括自所述撑开部211的端边缘径向辐射延伸以形成平面状或近似平面的锥面或弧面状的一定位面2172，以及连接于所述定位面2172外缘处并朝向远离所述撑开部211的一端延伸的锥状的第二血栓抓捕笼2173。所述第二血栓抓捕笼2173的远端收口以形成一第二收口面2175，所述第二收口面2175为一圆锥状的锥面，所述第二收口面2175的远端汇合于一锥顶2176上。第二血栓抓捕笼2173的外表面不与房间隔相贴靠，所述锥顶2176用于连接推送件52a的近端。
本实施例中设置有两个消融件210e，其中一个消融件210e是沿所述撑开部211周向设置至少一圈连接的或间隔的环形电极，另一个消融件210e是设置于所述第二定位部217的定位面2172上并沿撑开部211周向设置至少一圈连接的或间隔的环形电极，两个所述环形电极均为外部电极。具体的，所述撑开部211上的消融件210e为连续一圈的环形电极；所述第二定位部217的定位面2172上的消融件210e也是连续一圈的环形电极，所述环形电极与撑开部211的径向距离可设置为0～5mm，优选设置3mm。每一环形电极为具有较高弹性的，柔性的金属线材或金属片，如镍钛多股丝、或黄金弹簧包裹的镍钛多股丝等结构。每一消融件210e通过缝线缝合或胶粘于支撑骨架21a上。
每一消融件210e与支撑骨架21a之间相互绝缘。具体的，支撑骨架21a内外表面涂设有绝缘层，如镀有派瑞林绝缘涂层，从而使消融件210e与支撑骨架21a相互绝缘。进一步的，在撑开部211的外壁面与对应的消融件210e之间设置有绝缘膜27，在第二定位部217的外壁面与对应的消融件210e之间也设置有绝缘膜27；所述撑开部211上的绝缘膜27覆盖撑开部211的外壁面一周，所述第二定位部217的外壁面上的绝缘膜27覆盖第二定位部217的外壁面一周，且延伸至第二血栓抓捕笼2173上。所述撑开部211上的绝缘膜27与第二定位部217的外壁面上的绝缘膜27可以是两片分离的绝缘膜，也可以合并成一片绝缘膜。通过使用绝缘膜27能隔绝消融件210e和支撑骨架21a，不仅可以隔绝消融件210e与支撑骨架21a之间的热量传导，防止能量传递至支撑骨架21a上，从而将能量集中在消融件210e上，以对房间隔的造口内表面的组织及背朝左心房的表面于造口附近的组织进行消融，提高能量利用率；并且绝缘膜27能在电极面向血液的一侧形成绝缘屏障，减小通过血液的电流密度，减小电流对血液的加热，降低血栓形在的风险。
每一消融件210e通过导线521电性连接于射频电源，导线521的外表面绝缘处理。具体的，导线521的一端通过焊接连接于对应的消融件210e上，所述导线521的另一端经第二血栓抓捕笼2173、锥顶2176，及推送件52a连接于射频电源。
所述撑开部211上的消融件210e与第二定位部217上的消融件210e的极性选择包括但不限于以下三种方案：
1.撑开部211上的消融件210e与第二定位部217上的消融件210e均通过导线521连接于同一射频输出端口，中性电极板连接射频电源回路端。
2.撑开部211上的消融件210e通过导线521连接射频输出端口，第二定位部217上的消融件210e通过导线521连接射频电源回路端，无中性电极板。
3.第二定位部217上的消融件210e通过导线521连接射频输出端口，撑开部211上的消融件210e通过导线连接射频电源回路端，无中性电极板。
本实施例中的房间隔造口装置20e在使用时，撑开部211撑开房间隔上的穿孔以形成造口；第一血栓抓捕笼2133在左心房内展开，且第一定位部213a的定位面2132贴合于房间隔，第二血栓抓捕笼2173在右心房内展开，且第二定位部217的定位面2172贴合于房间隔，以将房间隔的加热区域附近的三维空间区域笼罩住，防止血液因加热形成的栓子进入循环系统，预防栓塞。
本实施例中的推送件52a为实心结构，推送件主体为绝缘的高分子材料制成，房间隔造口装置20e的第二定位部217的锥顶2176与推送件主体的近端通过热熔或胶粘剂相连接。导线521通过推送件52a内部延伸至尾端并与尾端连接头562电性连接，所述连接头562用于电性连接射频电源。
本实施例中的房间隔造口装置20e在使用时，需与装载器、鞘管、鞘芯、射频电源及电源联接线、中性电极板等联合使用。使用方法如下：
房间隔穿刺后，将导丝送入到左上肺静脉内，撤去穿刺套件。将鞘芯和鞘管沿导丝推送至左心房内，撤除导丝和鞘芯。
选用合适大小的房间隔造口装置20e。将推送器从装载器近端穿过，将房间隔造口装置20e远端与推送器近端连接。后撤推送器将房间隔造口装置20e收入装载器内。
连接装载器远端至鞘管近端，前推推送器使房间隔造口装置20e输送至鞘管前端。然后缓慢推送推送器或后撤鞘管，使房间隔造口装置20e的第一血栓抓捕笼2133完全张开(通过超声或DSA判断)。然后保持器械间无相对运动并向后拉动鞘管使撑开部211收容于房间隔的穿孔内，使撑开部211完全张开以撑开所述穿孔以形成造口，且第一血栓抓捕笼2133上的定位面2132紧贴在房间隔表面上。然后保持房间隔造口装置20和推送件位置不动，后撤鞘管，使第二定位部217的第二血栓抓捕笼2173完全打开，此时，第二血栓抓捕笼2173位于右心房内且第二血栓抓捕笼2173上的定位面2172紧贴在房间隔背朝左心房的表面上。
确认撑开部211及第二定位部217上的消融件210e均与房间隔完全贴合后，连接推送器远端到射频电源，并设置加热参数(如功率50W，持续时间30S)，然后启动加热。
加热停止后，可将房间隔造口装置20e回收至鞘管并撤除体外，并测量造口直径是否达到预期。
在其他实施例中，所述第一定位部213a的远端径向辐射延伸以形成若干定位杆，若干所述定位杆围成锥形或圆形，消融件210e设置于若干所述定位杆上，使消融件210e接触房间隔。
在其他实施例中，所述定位面2132上设置有若干定位点，消融件210e设置于定位点上，使消融件210e接触房间隔。
在其他实施例中，所述定位面2132上设置有若干定位杆，消融件210e设置于定位杆上，使消融件210e接触房间隔。
请参阅图19，图19是本申请第七实施例提供的房间隔造口系统的结构示意图。本申请第七实施例提供的房间隔造口系统的结构与第六实施例的结构相似，不同之处在于：在第七实施例中，房间隔造口装置20f的第一定位部213a的定位面2132上沿撑开部211周向设置至少一圈连接的或间隔的环形电极210e，撑开部211周向设置至少一圈连接的或间隔的环形电极210e，环形电极为外部电极。具体的，所述撑开部211上的消融件210e为连续一圈的环形电极；所述第一定位部213a的定位面2132上的消融件210e为连续一圈的环形电极，所述环形电极与撑开部211的径向距离可设置为0～5mm，优选设置3mm。每一环形电极为具有较高弹性的，柔性的金属线材或金属片，如镍钛多股丝、或黄金弹簧包裹的镍钛多股丝等结构。每一消融件210e通过缝线缝合或胶粘于支撑骨架21a上。
在撑开部211的外壁面与对应的消融件210e之间设置有绝缘膜27，在第一定位部213a的外壁面与对应的消融件210e之间也设置有绝缘膜27。所述撑开部211上的绝缘膜27覆盖撑开部211的外壁面一周，所述第一定位部213a的外壁面上的绝缘膜27覆盖定位面2132的外壁面一周，且延伸至第一血 栓抓捕笼2133上。所述撑开部211上的绝缘膜27与第一定位部213a的外壁面上的绝缘膜27可以是两片分离的绝缘膜，也可以合并成一片绝缘膜。通过使用绝缘膜27能隔绝消融件210e和支撑骨架21a，不仅可以隔绝消融件210e与支撑骨架21a之间的热量传导，防止能量传递至支撑骨架21a上，从而将能量集中在消融件210e上，以对房间隔的造口内表面的组织及面朝左心房的表面于造口附近的组织进行消融，提高能量利用率；并且绝缘膜27能在电极面向血液的一侧形成绝缘屏障，减小通过血液的电流密度，减小电流对血液的加热，降低血栓形在的风险。
本实施例中的房间隔造口系统在使用时，需与装载器、鞘管、鞘芯、可导电的推送器、射频电源及电源联接线、中性电极板等联合使用。具体的使用流程及方法与第六实施例相同，在此不再赘述。
请参阅图20，图20是本申请第八实施例提供的房间隔造口系统的结构示意图。本申请第八实施例提供的房间隔造口系统的结构与第六实施例的结构相似，不同之处在于：在第八实施例中，房间隔造口装置20g的第一定位部213a的定位面2132上沿撑开部211周向设置至少一圈连接的或间隔的环形电极210e，第二定位部217的定位面2172上沿撑开部211周向设置至少一圈连接的或间隔的环形电极210e，环形电极为外部电极。具体的，所述第一定位部213a的定位面2132上的消融件210e为连续一圈的环形电极，所述环形电极与撑开部211的径向距离可设置为0～5mm，优选设置3mm。所述第二定位部217的定位面2172上的消融件210e为连续一圈的环形电极，所述环形电极与撑开部211的径向距离可设置为0～5mm，优选设置3mm。每一环形电极为具有较高弹性的，柔性的金属线材或金属片，如镍钛多股丝、或黄金弹簧包裹的镍钛多股丝等结构。每一消融件210e通过缝线缝合或胶粘于支撑骨架21a上。
在第一定位部213a的外壁面与对应的消融件210e之间设置有绝缘膜27；在第二定位部217的外壁面与对应的消融件210e之间也设置有绝缘膜27。所述第一定位部213a的外壁面上的绝缘膜27覆盖定位面2132的外壁面一周，且延伸至第一血栓抓捕笼2133上；所述第二定位部217的外壁面上的绝缘膜27覆盖定位面2172的外壁面一周，且延伸至第二血栓抓捕笼2173上。通过使用绝缘膜27能隔绝消融件210e和支撑骨架21a，不仅可以隔绝消融件210e与支撑骨架21a之间的热量传导，防止能量传递至支撑骨架21a上，从而将能量集中在消融件210e上，以对房间隔面朝左心房的表面于造口附近的组织及背朝左心房的表面于造口附近的组织均进行消融，提高能量利用率；并且绝缘膜27能在环形电极面向血液的一侧形成绝缘屏障，减小通过血液的电流密度，减小电流对血液的加热，降低血栓形在的风险。
本实施例中的房间隔造口系统在使用时，需与装载器、鞘管、鞘芯、可导电的推送器、射频电源及电源联接线、中性电极板等联合使用。具体的使用流程及方法与第六实施例相同，在此不再赘述。
在其他实施例中，撑开部211的外壁面上也可以覆盖一周绝缘膜，所述撑开部211、第一定位部213a及第二定位部217上的绝缘膜可以制作成一体结构。
请参阅图21-图24，图21是本申请第九实施例提供的房间隔造口系统的结构示意图；图22是图21中的房间隔造口系统的消融封堵装置去除绝缘膜的结构示意图；图23是图21中沿XXIII-XXIII线的剖视图；图24是图23中XXIV部分的放大图。本申请第九实施例提供的房间隔造口系统的结构与第六实施例的结构相似，不同之处在于：在第九实施例中，在房间隔造口装置20h完全释放的状态下，支撑骨架21b包括内凹的回转曲面的撑开部211、设置于所述撑开部211一端的第一定位部213b，以及设置于所述撑开部211相对的另一端的第二定位部217a。所述第一定位部213b的近端与所述撑开部211相连，远端径向辐射延伸；所述第二定位部217a的近端与所述撑开部211相连，远端轴向延伸并汇合。
本实施例中，支撑骨架21b为编织网状的镍钛合金支架，第一定位部213b为单层编织网结构，当房间隔造口装置20h通过鞘管输送时，支撑骨架21b的直径可收缩至较小状态以便在鞘管中输送；当在心脏中释放时，可自动膨胀至所需形状尺寸，并且撑开部211能对与其接触的房间隔的穿孔内壁组织产生一定的径向支撑作用，并能将房间隔的穿孔撑开以形成造口；所述第一定位部213b贴合于房间隔面朝左心房的表面，所述第二定位部217a位于右心房内且贴合于房间隔背朝左心房的表面，从而将撑开部211定位于房间隔的造口内。
所述第一定位部213a包括自所述撑开部211的端边缘径向辐射延伸形成的圆锥形或圆形的一定位面2132，以及自定位面2132外缘向远端弯曲的弯曲框2134，所述弯曲框2134朝远端圆滑过渡弯曲，避免损伤心房组织。
所述第二定位部217a包括自所述撑开部211的端边缘径向朝外辐射延伸以形成的圆锥形或圆形的一定位面2172，以及连接于所述定位面2172外缘处并朝向远离所述撑开部211的一端延伸的圆锥状的第二血栓抓捕笼2173。所述第二血栓抓捕笼2173的远端收口以汇合于一锥顶2176上。所述锥顶2176用于连接推送件52a的近端。
本实施例中包括设置于第二定位部217a的定位面2172的消融件210e，以及设置于第一定位部213a的定位面2132上的消融件210f。所述消融件210e是沿撑开部211周向设置至少一圈连接的或间隔的环形电极，所述环形电极为外部电极。具体的，消融件210e为连续一圈的环形电极，所述环形电极与撑开部211的径向距离可设置为0～5mm，优选设置3mm。消融件210e为具有较高弹性的，柔性的金属线材或金属片，如镍钛多股丝、或黄金弹簧包裹的镍钛多股丝等结构。消融件210e通过缝线缝合或胶粘于第二定位部217a的定位面2172上。消融件210f是第一定位部213a的定位面2132上的部分电性裸露的金属丝材，部分电性裸露区域直接作为电极，即支撑骨架21b的金属丝材在定位面2132上对应消融件210f的区域没有涂设绝缘涂层，所述定位面2132上电性裸露的金属丝材区域是沿撑开部211周向设置连接的或间隔的至少一圈。本实施例中，消融件210f是沿撑开部211周向连接的设置一圈的裸露的金属丝材，所述消融件210f与撑开部211的径向距离可设置为0～5mm，优选设置3mm。裸露的金属丝材可选自记忆合金或者不锈钢，优选记忆合金，优选镍钛合金。
如图21所示，消融件210e与第二定位部217a的定位面2172之间相互绝缘，具体的，支撑骨架21a上至少在对应消融件210f的区域外与组织或血液接触的外表面涂设有绝缘涂层，即除设置为消融件210f以外的表面全部涂设有绝缘涂层，如镀有派瑞林绝缘涂层，从而使消融件210e与支撑骨架21a相互绝缘。进一步的，在第二定位部217a的外壁面全部覆盖有绝缘膜27，所述绝缘膜27将消融件210e与支撑骨架21b绝缘。所述第一定位部213a的背朝所述撑开部211的侧面对应消融件210f处涂设有绝缘涂层，所述绝缘涂层可以是但不限于派瑞林涂层、聚四氟乙烯涂层、聚氨酯涂层、或聚酰亚胺涂层。通过使用绝缘膜27能隔绝消融件210e和支撑骨架21b，第一定位部213a除设置为消融件210f以外的内外表面涂设有绝缘材料能隔绝消融件210f与支撑骨架21b，不仅可以隔绝消融件210e、210f与支撑骨架21b之间的热量传导，防止能量传递至支撑骨架21b上，从而将能量集中在消融件210e、210f上，以对房间隔面朝左心房的表面于造口附近的组织及背朝左心房的表面于造口附近的组织均进行消融，提高能量利用率；并且绝缘膜27及绝缘涂层能在电极面向血液的一侧形成绝缘屏障，减小通过血液的电流密度，减小电流对血液的加热，降低血栓形在的风险。
在其他实施例中，所述第一定位部213a上除设置为消融件210f以外的外表面均套设有绝缘套管。
在其他实施例中，所述第一定位部213a背朝所述撑开部211的侧面对应消融件210f的区域设置有绝缘膜，所述绝缘膜通过缝线缝合或胶粘于所述支撑骨架上。
消融件210e通过导线521电性连接于射频电源，导线521的外表面绝缘处理。具体的，导线521的一端通过焊接连接于消融件210e上，导线521的另一端经第二定位部217a、锥顶2176，推送件52a及连接头562连接于射频电源。消融件210f通过另一导线521电性连接于射频电源，具体的，另一导线521的一端焊接于支撑骨架21b的锥顶2176，使支撑骨架21b电性连接于导线521，所述导线的另一端经推送件52a及连接头562连接于射频电源。
本实施例中的消融件210e、210f的极性选择包括但不限于以下三种方案：
1消融件210e与消融件210f均通过导线521连接于同一射频输出端口，中性电极板连接射频电源回路端。
2.消融件210e通过导线521连接射频输出端口，消融件210f通过导线521连接射频电源回路端，无中性电极板。
3.消融件210f通过导线521连接射频输出端口，消融件210e通过导线连接射频电源回路端，无中性电极板。
本实施例中的房间隔造口系统在使用时，需与装载器、鞘管、鞘芯、可导电的推送器、射频电源及电源联接线、中性电极板等联合使用。具体的使用流程及方法与第六实施例相同，在此不再赘述。
请参阅图25及图26，图25是本申请第十实施例提供的房间隔造口系统的结构示意图；图26是图25中的房间隔造口系统的消融封堵装置去除绝缘膜的结构示意图。本申请第十实施例提供的房间隔造口系统的结构与第六实施例的结构相似，不同之处在于：在房间隔造口装置20i完全释放的状态下，所述支撑骨架21c包括圆筒状的撑开部211、设置于所述撑开部211一端的第一定位部213c，以及设置于所述撑开部211相对的另一端的第二定位部217b；所述第一定位部213c的近端与所述撑开部211相连，远端轴向延伸并汇合；所述第二定位部217的近端与所述撑开部211相连，远端轴向延伸并汇合。所述第一定位部213c和第二定位部217b均为双层编织网结构。
本实施例中，支撑骨架21c为编织网状的镍钛合金支架，当房间隔造口装置20i通过鞘管输送时，支撑骨架21c的直径可收缩至较小状态以便在鞘管中输送；当在心脏中释放时，可自动膨胀至所需形状尺寸，并且撑开部211能对与其接触的房间隔的穿孔的内壁组织产生一定的径向支撑作用，并能将房间隔的穿孔撑开以形成造口；所述第一定位部213c位于左心房内且贴合于房间隔面朝左心房的表面，所 述第二定位部217b位于右心房内且贴合于房间隔背朝左心房的表面，从而将撑开部211定位于房间隔的造口内。
如图26所示，所述第一定位部213c包括自所述撑开部211的端边径向朝外辐射延伸以形成的一定位面2132，以及连接于所述定位面2132外缘处并朝远离所述撑开部211的一端延伸的圆锥状的第一血栓抓捕笼2133。所述定位面2132可以为平面状或近似平面的锥面或弧面状，所述第一血栓抓捕笼2133的外表面不与房间隔相贴靠。所述第一血栓抓捕笼2133的远端收口汇合于一顶点2136上，所述顶点2136用于在植入所述房间隔造口装置20时顶点2136能顺畅地穿过房间隔上的穿孔。
所述第二定位部217b包括自所述撑开部211的端边径向朝外辐射延伸以形成的一定位面2172，以及连接于所述定位面2172外缘处并朝向远离所述撑开部211的一端延伸的圆锥状的第二血栓抓捕笼2173。所述定位面2172可以为平面状或近似平面的锥面或弧面状，所述第二定位部217b的外表面不与房间隔相贴靠。所述第二血栓抓捕笼2173的远端收口并汇合于一锥顶2176上，所述锥顶2176用于连接推送件52a的近端。
本实施例中设置有三个消融件，分别为设置于所述撑开部211的外壁面上的一消融件210e、设置于所述第一定位部213c的定位面2132上的一消融件210f，以及设置于所述第二定位部217b的定位面2172上的一消融件210f。所述撑开部211上的消融件210e是沿所述撑开部211周向设置至少一圈连接的或间隔的环形电极，所述环形电极为外部电极，具体的，所述撑开部211上的消融件210e为连续一圈的环形电极，所述环形电极为具有较高弹性的，柔性的金属线材或金属片，如镍钛多股丝、或黄金弹簧包裹的镍钛多股丝等结构。消融件210e通过缝线缝合或胶粘于支撑骨架21a上。
所述第一定位部213c的定位面2132上的消融件210f是支撑骨架21c的定位面2132上的部分电性裸露的金属丝材，即支撑骨架21c的金属丝材在设置为消融件210f的区域上没有涂设绝缘涂层，部分电性裸露的金属丝材直接作为消融件210f的电极。所述定位面2132上裸露的金属丝材区域是沿撑开部211周向连接的或间隔的设置至少一圈。本实施例中，第一定位部213c上的消融件210f是沿撑开部211周向连接的设置一圈，所述消融件210f与撑开部211的径向距离可设置为0～5mm，优选设置3mm。所述第二定位部217b的定位面2172上的消融件210f是支撑骨架21c的定位面2172上的部分电性裸露的金属丝材，即支撑骨架21c的金属丝材在定位面2172设置有消融件210f的区域上没有涂设绝缘涂层，所述定位面2172上裸露的金属丝材区域是沿撑开部211周向设置连接的或间隔的至少一圈。本实施例中，第二定位部217b上的消融件210f是沿撑开部211周向连接的设置一圈，所述消融件210f与撑开部211的径向距离可设置为0～5mm，优选设置3mm。裸露的金属丝材可选自记忆合金或者不锈钢，优选记忆合金，优选镍钛合金。
如图25所示，消融件210e与撑开部211之间相互绝缘。具体的，支撑骨架21c上除设置为消融件210f以外的内外表面全部镀有派瑞林绝缘涂层，从而使消融件210e、210f与支撑骨架21a相互绝缘。进一步的，在撑开部211与消融件210e之间设置有绝缘膜27，即绝缘膜27覆盖于撑开部211的外壁面一周，使所述绝缘膜27将消融件210e与支撑骨架21c绝缘。所述第一定位部213c及第二定位部217b的内外表面除消融件210f的区域外均涂设有绝缘涂层，所述绝缘涂层可以是但不限于派瑞林涂层、聚四氟乙烯涂层、聚氨酯涂层、或聚酰亚胺涂层。通过使用绝缘膜27及绝缘涂层能隔绝消融件210e、210f与支撑骨架21b，不仅可以隔绝消融件210e、210f与支撑骨架21c之间的热量传导，防止能量传递至支撑骨架21c上，从而将能量集中在消融件210e、210f上，以对房间隔的造口的内表面、所述房间隔面朝左心房的表面于造口附近的组织及房间隔背朝左心房的表面于造口附近的组织均进行消融，提高能量利用率；并且绝缘膜27及绝缘涂层能在电极面向血液的一侧形成绝缘屏障，减小通过血液的电流密度，减小电流对血液的加热，降低血栓形在的风险。
消融件210e通过导线521电性连接于射频电源，导线521的外表面绝缘处理。具体的，导线521的一端通过焊接连接于对应的消融件210e上，所述导线521的另一端经第二血栓抓捕笼2173、锥顶2176、推送件52a，及连接头562连接于射频电源。两个消融件210f通过另一导线521电性连接于射频电源，具体的，另一导线521的一端焊接于支撑骨架21c的锥顶2176处，使支撑骨架21c电性连接于导线521，所述导线的另一端经推送件52连接于射频电源。
所述撑开部211上的消融件210e与第二定位部217b和第一定位部213c上的消融件210f的极性选择包括但不限于以下三种方案：
1.撑开部211上的消融件210e与近第二定位部217b及第一定位部213c上的消融件210f均通过导线521连接于同一射频输出端口，中性电极板连接射频电源回路端。
2.撑开部211上的消融件210e通过导线521连接射频输出端口，第二定位部217b及第一定位部213c上的消融件210f通过导线521连接射频电源回路端，无中性电极板。
3.第二定位部217b及第一定位部213c上的消融件210f通过导线521连接射频输出端口，撑开部211上的消融件210e通过导线连接射频电源回路端，无中性电极板。
本实施例中的房间隔造口系统在使用时，需与装载器、鞘管、鞘芯、可导电的推送器、射频电源及电源联接线、中性电极板等联合使用。具体的使用流程及方法与第六实施例相同，在此不再赘述。
请参阅图27，图27是本申请第十一实施例提供的房间隔造口系统的结构示意图。本申请第十一实施例提供的房间隔造口系统的结构与第六实施例的结构相似，不同之处在于：在第十一实施例中设置有三个消融件210e，其中一个消融件210e是沿所述撑开部211周向设置至少一圈连接的或间隔的环形电极；另一个消融件210e是设置于所述第一定位部213a的定位面2132上并沿撑开部211周向设置至少一圈连接的或间隔的环形电极；还有一个消融件210e是设置于所述第二定位部217的定位面2172上并沿撑开部211周向设置至少一圈连接的或间隔的环形电极。具体的，所述撑开部211上的消融件210e为连续一圈的环形电极；所述第一定位部213a及第二定位部217的定位面2132、2172上的消融件210e均为连续一圈的环形电极，所述环形电极与撑开部211的径向距离可设置为0～5mm，优选设置3mm。每一环形电极为具有较高弹性的，柔性的金属线材或金属片，如镍钛多股丝、或黄金弹簧包裹的镍钛多股丝等结构。每一消融件210e通过缝线缝合或胶粘于支撑骨架21a上。
每一消融件210e与支撑骨架21a之间相互绝缘，具体的，支撑骨架21a外表面镀有派瑞林绝缘涂层，从而使消融件210e与支撑骨架21a相互绝缘。进一步的，在撑开部211的外壁面与对应的消融件210e之间设置有绝缘膜27，在第一定位部213a的外壁面与对应的消融件210e之间也设置有绝缘膜27，以及在第二定位部217的外壁面与对应的消融件210e之间也设置有绝缘膜27。具体的，所述撑开部211上的绝缘膜27覆盖撑开部211的外壁面一周；所述第一定位部213a的外壁面上的绝缘膜27覆盖第二定位部213a的定位面2132，且延伸至第一血栓抓捕笼2133上；所述第二定位部217的外壁面上的绝缘膜27覆盖第二定位部217的定位面2172，且延伸至第二血栓抓捕笼2173上。三个绝缘膜27可以是三片分离的绝缘膜，也可以合并成一片绝缘膜。通过使用绝缘膜27能隔绝三个消融件210e和支撑骨架21a，不仅可以隔绝消融件210e与支撑骨架21a之间的热量传导，防止能量传递至支撑骨架21a上，从而将能量集中在消融件210e上，以对房间隔的造口内表面的组织、面朝左心房的表面于造口附近的组织，以及背朝左心房的表面于造口附近的组织进行消融，提高能量利用率；并且绝缘膜27能在电极面向血液的一侧形成绝缘屏障，减小通过血液的电流密度，减小电流对血液的加热，降低血栓形在的风险。
每一消融件210e通过导线521电性连接于射频电源，导线521的外表面绝缘处理。具体的，每一导线521的一端通过焊接连接于对应的消融件210e上，所述导线521的另一端经支撑骨架21a及推送件52a连接于射频电源。
所述支撑骨架21a上的三个消融件210e的极性选择包括但不限于以下六种方案：
1.撑开部211上的消融件210e、第一定位部213a的消融件210e和第二定位部217的消融件210e均连接同一射频输出端口，中性电极板连接射频电源回路端。
2.第二定位部217的消融件210e和第一定位部213a的消融件210e连接射频输出端口，撑开部211上的消融件210e连接射频电源回路端，无中性电极板。
3.撑开部211上的消融件210e连接射频输出端口，第二定位部217的消融件210e和第一定位部213a的消融件210e连接射频电源回路端，无中性电极板。
4.第二定位部217的消融件210e和撑开部211上的消融件210e连接射频输出端口，第一定位部213a的消融件210e连接射频电源回路端，无中性电极板。
5.第二定位部217的消融件210e、第一定位部213a的消融件210e与撑开部211上的消融件210e分别连接三相电压源A相、B相、C相输出端口，三个端口输出三路等幅值、同频率、相位角依次相差120°的正弦交流电，中性电极板连接射频电源回路端。
6.第二定位部217的消融件210e、第一定位部213a的消融件210e与撑开部211上的消融件210e分别连接三相电压源A相、B相、C相输出端口，三个端口输出三路等幅值、同频率、相位角依次相差120°的正弦交流电，无中性电极板。
本实施例中的房间隔造口系统在使用时，需与装载器、鞘管、鞘芯、可导电的推送器、射频电源及电源联接线、中性电极板等联合使用。具体的使用流程及方法与第六实施例相同，在此不再赘述。
以上是本申请实施例的实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本申请实施例原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也视为本申请的保护范围。

Claims (28)

  1. 一种改进消融效果的房间隔造口装置，其包括用于撑开房间隔上的穿孔的支撑骨架，其特征在于，所述支撑骨架上设置有至少一消融件，所述消融件接触所述房间隔并用于对所述房间隔进行消融，所述装置上除所述消融件外不能对血液或组织进行消融。
  2. 根据权利要求1所述的房间隔造口装置，其特征在于，所述消融件为设置于所述支撑骨架上的外部电极。
  3. 根据权利要求2所述的房间隔造口装置，其特征在于，所述外部电极通过缝线缝合或胶粘至所述支撑骨架上。
  4. 根据权利要求2所述的房间隔造口装置，其特征在于，所述消融件为设置于所述支撑骨架上的若干点状电极或者杆状电极，若干所述点状电极或者杆状电极沿所述支撑骨架设置至少一圈。
  5. 根据权利要求2所述的房间隔造口装置，其特征在于，所述消融件为设置于支撑骨架的外壁周向上的环状电极。
  6. 根据权利要求2所述的房间隔造口装置，其特征在于，所述支撑骨架上至少在与所述消融件接触区域的外表面进行绝缘处理。
  7. 根据权利要求6所述的房间隔造口装置，其特征在于，所述支撑骨架与所述消融件之间设置有绝缘膜。
  8. 根据权利要求7所述的房间隔造口装置，其特征在于，所述绝缘膜设置于所述支撑骨架对应所述消融件的表面，或者贴合于所述消融件对应所述支撑骨架的表面。
  9. 根据权利要求6所述的房间隔造口装置，其特征在于，所述支撑骨架对应所述消融件的表面涂设绝缘涂层，或者所述消融件对应所述支撑骨架的表面涂设绝缘涂层。
  10. 根据权利要求1所述的房间隔造口装置，其特征在于，所述支撑骨架是金属支架，所述消融件是在所述金属支架贴合于所述房间隔的外壁面上设置至少一圈连接的或间断的电性裸露区域。
  11. 根据权利要求10所述的房间隔造口装置，其特征在于，所述支撑骨架除对应所述消融件的区域外进行绝缘处理。
  12. 根据权利要求10所述的房间隔造口装置，其特征在于，所述支撑骨架，至少在除对应所述消融件的区域外与组织或血液接触的外表面涂设有绝缘涂层。
  13. 根据权利要求1至12任一所述的房间隔造口装置，其特征在于，所述支撑骨架包括用于撑开所述房间隔上的穿孔的撑开部、设置于所述撑开部一端的第一定位部，以及设置于所述撑开部相对的另一端的第二定位部，所述消融件设置于所述撑开部的外壁面、第一定位部的外壁面，或者第二定位部的外壁面，所述消融件与所述撑开部、所述第一定位部，或者所述第二定位部之间设置有绝缘膜或绝缘涂层。
  14. 根据权利要求13所述的房间隔造口装置，其特征在于，所述消融件可设置在所述撑开部、所述第一定位部或者所述第二定位部上与房间隔接触的位置。
  15. 根据权利要求13所述的房间隔造口装置，其特征在于，所述消融件沿所述撑开部的外壁面设置至少一圈。
  16. 根据权利要求14所述的房间隔造口装置，其特征在于，所述第一定位部位于左心房内且至少部分贴合于所述房间隔，所述消融件是绕所述撑开部至少一圈设置于所述第一定位部上的连接的或间断的环状电极，所述绝缘膜或所述绝缘涂层位于所述环状电极与所述第一定位部之间。
  17. 根据权利要求16所述的房间隔造口装置，其特征在于，所述第一定位部包括自所述撑开部的端边缘径向辐射延伸以形成的定位面，所述定位面至少部分贴合于所述房间隔，所述环状电极设置于所述定位面上，所述绝缘膜或所述绝缘涂层位于所述环状电极与所述定位面之间。
  18. 根据权利要求13所述的房间隔造口装置，其特征在于，所述第二定位部位于右心房内且贴合于所述房间隔，所述消融件是绕所述撑开部至少一圈设置于所述第二定位部上的连接的或间断的环状电极，所述绝缘膜或所述绝缘涂层位于所述环状电极与所述定位框之间。
  19. 根据权利要求18所述的房间隔造口装置，其特征在于，所述第二定位部包括自所述撑开部的端边缘径向辐射延伸以形成的定位面，所述定位面至少部分贴合于所述房间隔，所述环状电极设置于所述定位面上，所述绝缘膜或所述绝缘涂层位于所述环状电极与所述定位面之间。
  20. 根据权利要求13所述的房间隔造口装置，其特征在于，所述撑开部的径向尺寸可以调节。
  21. 根据权利要求13所述的房间隔造口装置，其特征在于，所述消融件包括两个电极，两个所述电极同时设置于所述撑开部、所述第一定位部、所述第二定位部三者之一上；两个所述电极分别设置于所述撑开部、所述第一定位部、所述第二定位部的三者之二上。
  22. 根据权利要求21所述的房间隔造口装置，其特征在于，两个所述电极均电性连接于射频电源输出端。
  23. 根据权利要求21所述的房间隔造口装置，其特征在于，其中一电极电性连接于射频电源输出端，另一电极连接射频电源回路端。
  24. 根据权利要求13所述的房间隔造口装置，其特征在于，所述消融件包括三个电极，三个所述电极同时设置于所述撑开部、所述第一定位部、所述第二定位部三者之一上；三个所述电极分别设置于所述撑开部、所述第一定位部、所述第二定位部的三者之二上；或三个所述电极分别设置于所述撑开部、所述第一定位部、所述第二定位部。
  25. 根据权利要求24所述的房间隔造口装置，其特征在于，三个所述电极均电性连接于射频电源。
  26. 根据权利要求24所述的房间隔造口装置，其特征在于，其中二个所述电极电性连接于射频电源，另一电极连接射频电源回路端；或者其中一所述电极电性连接于射频电源，另一电极连接射频电源回路端。
  27. 根据权利要求24所述的房间隔造口装置，其特征在于，三个所述电极分别连接于三相电源。
  28. 一种房间隔造口系统，包括权利要求1-27任意一项所述的房间隔造口装置、控制所述房间隔造口装置的造口装置控制机构及射频电源，所述射频电源通过造口装置控制机构与所述房间隔造口装置的消融件电连接。
PCT/CN2019/116184 2018-11-09 2019-11-07 改进消融效果的房间隔造口装置及房间隔造口系统 WO2020094085A1 (zh)

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