WO2020094087A1 - Dispositif de septostomie auriculaire à méthode d'ablation améliorée et système de septostomie auriculaire - Google Patents

Dispositif de septostomie auriculaire à méthode d'ablation améliorée et système de septostomie auriculaire Download PDF

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Publication number
WO2020094087A1
WO2020094087A1 PCT/CN2019/116191 CN2019116191W WO2020094087A1 WO 2020094087 A1 WO2020094087 A1 WO 2020094087A1 CN 2019116191 W CN2019116191 W CN 2019116191W WO 2020094087 A1 WO2020094087 A1 WO 2020094087A1
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Prior art keywords
electrode
positioning
interatrial
support frame
power supply
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PCT/CN2019/116191
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English (en)
Chinese (zh)
Inventor
王永胜
王坤
董元博
Original Assignee
杭州诺生医疗科技有限公司
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Priority claimed from CN201821851963.2U external-priority patent/CN209611297U/zh
Priority claimed from CN201811336798.1A external-priority patent/CN111166463A/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 WO2020094087A1 publication Critical patent/WO2020094087A1/fr

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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

Definitions

  • the present application relates to the technical field of interventional medical devices, in particular to an atrial septostomy device with an improved ablation method for 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 with an improved ablation method that is difficult to seal the ostomy, and an atrial septal ostomy system provided with the atrial septal ostomy device.
  • the present application provides an improved ablation method of an interatrial septal ostomy device, which includes a supporting framework for expanding a perforation on the interatrial septum, and the interatrial ostomy device further includes a support provided on the support
  • An ablation member on the skeleton the ablation member includes a first electrode and a second electrode, one of the first electrode and the second electrode is electrically connected to the RF power supply, and the other electrode is connected to the RF power supply circuit end, to Form a current loop to receive energy from the radio frequency power supply to ablate the interatrial septum.
  • 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.
  • a perforated support skeleton on the interval, the interatrial septal stoma device further includes an ablation member provided on the support skeleton, the radio frequency power supply is electrically connected to the interatrial septal stoma device through a stoma device control mechanism, the ablation
  • the device includes a first electrode and a second electrode, one of the first electrode and the second electrode is electrically connected to the output end of the RF power supply, and the other electrode is connected to the RF power supply loop end to form a current loop to receive the RF power supply Energy ablate the interatrial septum.
  • the interatrial septal ostomy system of the present application includes a support frame that expands the perforations in the interatrial septum, and an ablation member provided on the support frame, wherein one electrode is electrically connected to the output end of the RF power supply, and the other electrode is connected to the RF power supply circuit End, so that the first electrode and the second electrode form a current loop to receive the energy of the radio frequency power to ablate the atrial septum, inactivate the atrial septal tissue near the perforation, and prevent endothelial crawling due to tissue repair
  • the perforation is blocked, and after the stoma is made through the interatrial septostomy system, the shape of the perforation after the stoma can be fixed, the stoma is not easy to block, and the stoma can be kept smooth; in addition, the first electrode and the second electrode are provided On the supporting framework, it is easy to control the current distribution of the ablation piece, so that the current can be concentrated in the interat
  • FIG. 1 is a schematic structural diagram of an interatrial septal ostomy system provided in the first embodiment 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 schematic structural diagram of an ablation and sealing device for an interatrial septal ostomy system according to a third embodiment of the present application.
  • FIG. 14 is a schematic structural diagram of an ablation and sealing device for an interatrial septal ostomy system according to a fourth embodiment of the present application.
  • FIG. 15 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.
  • 16 is a schematic structural diagram of an ablation and sealing device for an interatrial septal ostomy system according to a sixth embodiment of the present application.
  • FIG. 17 is a schematic structural diagram of an ablation and sealing device for an interatrial septal ostomy system according to a seventh embodiment of the present application.
  • FIG. 18 is a schematic structural diagram of an interatrial septal ostomy system provided in an eighth embodiment of the present application.
  • FIG. 19 is a schematic structural view of the insulating film added to the ablation sealing device of the interatrial septostomy system in FIG. 18;
  • FIG. 20 is a schematic structural diagram of an interatrial septal ostomy system provided in a ninth embodiment of the present application.
  • 21 is a schematic structural diagram of an interatrial septal ostomy system provided in a tenth embodiment of the present application.
  • FIG. 22 is a schematic structural diagram of an interatrial septal ostomy system provided in an eleventh embodiment of the present application.
  • FIG. 23 is a schematic structural view of the insulating film added to the ablation sealing device of the interatrial septal ostomy system in FIG. 22;
  • FIG. 24 is a cross-sectional view taken along line XXIV-XXIV in FIG. 23;
  • FIG. 25 is an enlarged view of the XXV part in FIG. 24;
  • 26 is a schematic structural diagram of an interatrial septal ostomy system provided in a twelfth embodiment of the present application.
  • FIG. 27 is a schematic structural view of the insulating film added to the ablation and sealing device of the atrial septal ostomy system in FIG. 26;
  • FIG. 28 is a schematic structural diagram of an interatrial septostomy system provided in the thirteenth 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 embodiment of an improved ablation septal ostomy system according to a first embodiment of the present application
  • FIG. 2 is an interatrial septal ostomy system in FIG. 1 Enlarged view of the atrial septal ostomy device.
  • 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 interatrial septal ostomy device 20 includes a support frame 21 for expanding the perforations in the interatrial septum, and the support frame 21 is used for expanding the perforations to form a stoma.
  • the support frame 21 is provided with an ablation element 23, the ablation element 23 includes a first electrode 231 and a second electrode 233, the first electrode 231 and the second electrode 233 are in contact with the interatrial septum, the first electrode One of the electrode 231 and the second electrode 233 is electrically connected to the output terminal of the RF power supply, and the other electrode is connected to the loop end of the RF power supply, that is, when the first electrode 231 is electrically connected to the output terminal of the RF power supply, the second electrode 233 is connected to the RF power supply Loop end; or when the second electrode 233 is electrically connected to the output end of the RF power supply, the first electrode 231 is connected to the loop end of the RF power supply.
  • the first electrode 231 and the second electrode 233 form a current loop to receive energy from the output end of the radio frequency power supply to ablate the interatrial septum.
  • the first electrode 231 is used as an electrode for ablation
  • the second electrode 233 is used as an electrode connected to the RF power supply circuit end.
  • the atrial septostomy device 20 of the interatrial septostomy system 100 of the present application includes a support frame 21 that expands the perforations in the interatrial septum, and an ablation member 23 provided on the support frame 21, the first electrode 231 and the first Both electrodes 233 are in contact with the interatrial septum tissue near the perforation, one of the electrodes is electrically connected to the output end of the RF power supply, the other electrode is connected to the end of the RF power supply loop, and the first electrode 231 and the second electrode 233 form a current
  • the circuit ablates the interatrial septum with the energy of the radio frequency power supply, thereby inactivating the interstitial septal tissue near the perforation, preventing the repair of tissues from clogging the perforation by endothelial crawling, and making the ostomy through the atrial septostomy system 100 After that, the form of perforation after stoma can be fixed.
  • the shape of the stoma treated by the interatrial septal ostomy device 20 is relatively regular, and is not easy to block, which can keep the stoma open and further smooth the blood flow in the left and right heart chambers.
  • the distance between the first electrode 231 and the second electrode 233 is short, and it is easy to control the current distribution of the ablation member 23, so that the current can be concentrated on
  • the interstitial tissue is released between the first electrode 231 and the second electrode 233, that is, the energy is easily gathered and can cause continuous damage, prevent the loss of radio frequency energy on the electrode, improve the ablation efficiency, and prevent damage to other tissues of the body.
  • the support skeleton 21 is a self-expanding ostomy device.
  • the support skeleton 21 may be a superelastic or memory alloy metal support skeleton or an elastic non-metallic support skeleton.
  • 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 atrial septal ostomy device 20 is released in the vicinity of the cardiac atrial septum, the support skeleton 21 can automatically expand to the desired shape and size, so that the support skeleton 21 can expand the perforation in the atrial septum to form a stoma, that is, the The part of the support frame 21 inside the perforation produces a radial support effect on the inner wall of the perforation.
  • 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 or diamond-like 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 disk, 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 perforation of the interatrial septum; the extension 214 The perforation that deviates from the interatrial septum when the extension part 211 extends to the distal end can be avoided, which can not expand the tissue there. Therefore, the extension part 214 can compensate for the defects caused by the extension part 211 deviating from the perforation influences.
  • the expansion portion 211 when the supporting framework 21 is completely released into the perforation of the interatrial septum, the expansion portion 211 can expand radially after being released, so that the perforation of the interatrial septum can be evenly expanded to expand the perforation of the interatrial septum Form a 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 peaks of the structure are connected, and the distal end of the first positioning portion 213 extends radially to form a tapered or circular positioning surface 2132.
  • the first positioning portion 213 further includes an outer edge warping structure, which is a smooth transition curve from the outer edge portion of the first positioning portion 213 to the side away from the spreading portion 211 to avoid damage to the atrium organization.
  • 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 supporting skeleton 21 may be a mesh-shaped bracket, a rod-shaped bracket, a multi-layer wave-shaped bracket, 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
  • the shape of the spreading portion 211 may be various, for example, the spreading portion 211 may be a curved shape, a cylindrical shape, an elliptical cylindrical shape or a combination thereof in which the outer side wall is concave or / and convex.
  • 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 portion 215 is conical, and includes a plurality of extension pieces 2151 provided at the proximal end, and a connecting piece 2152 located at the distal end.
  • the plurality of extension pieces 2151 are connected between the extension portion 214 and the connection piece 2152.
  • the connection piece 2152 is used for ⁇ ⁇ ostomy device control mechanism 50.
  • 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 control mechanism 50 of the ostomy device.
  • the first electrode 231 of the ablation member 23 is disposed on the spreading portion 211, and the second electrode 233 is disposed on the first positioning portion 213.
  • the first electrode 231 is disposed on the outer wall surface of the expansion portion 211
  • the second electrode 233 is disposed on the positioning surface 2132 of the first positioning portion 213, the outer wall surface of the expansion portion 211 and the first positioning portion 213
  • both the first electrode 231 and the second electrode 233 contact the interatrial septum, and a current loop is formed between the first electrode 231 and the second electrode 233, that is, current flows only between the first electrode 233 and the second electrode 233
  • the tissues in the room are separated to prevent the current from damaging other tissues of the human body, and the radio frequency energy can be concentrated for the first electrode 233 for ablation to achieve a better ablation effect.
  • the ablation member 23 includes a plurality of first flexible wires 235 and a plurality of second flexible wires 236.
  • the structure of the first flexible wire 235 is the same as that of the second flexible wire 236. Only the length is different.
  • the first flexible wire 235 and the second flexible wire 236 are arranged side by side at intervals.
  • the proximal end of each first flexible wire 235 is provided with an ablation portion, which is the first electrode 231, and the distal end of the first flexible wire 235 is provided with a connection portion 237.
  • Each first flexible wire 235 is sewn to the outer wall surface of the support frame 21 by gluing or stitching.
  • the first electrode 231 of each first flexible wire 235 is located on the outer wall surface of the expansion portion 211. Specifically, the first electrodes 231 are arranged at least one turn along the circumferential direction of the expansion portion 211; A connecting portion 237 of a flexible wire 235 extends axially out of the connecting member 2152 and is electrically connected to the radio frequency source.
  • the proximal end of each second flexible wire 236 is provided with an ablation portion, the ablation portion is the second electrode 233, the distal end of the second flexible wire 236 is provided with a connection portion 237, the second of each second flexible wire 236
  • the electrodes 233 are located on the positioning surface 2132 of the first positioning portion 213. Specifically, the second electrodes 233 are provided at least one turn along the circumferential direction of the spreading portion 211.
  • the connecting portion 237 of each second flexible wire 236 extends axially out of the connecting member 2152 and is connected to the RF power circuit end.
  • both the first flexible wire 235 and the second flexible wire 236 include a flexible metal layer 2351, an insulating layer 2353 sleeved over the metal layer 2351, and glued to the
  • the insulating layer 2353 is used for the adhesive layer 2355 pasted on the support frame 21.
  • the first electrode 231 and the second electrode 233 are formed by removing the insulating layer 2353 on the side facing away from the adhesive layer 2355 at the proximal ends of the first flexible wire 235 and the second flexible wire 236, respectively; the connection portion 237 is respectively
  • the insulating layer 2353 and the adhesive layer 2355 are formed at the distal ends of the first flexible wire 235 and the second flexible wire 236.
  • the ostomy device control mechanism 50 includes a pushing member 52, an outer sheath tube assembly 54, and a control handle 56.
  • the pushing member 52 is detachably connected or integrally connected to the interosseous stoma device 20.
  • the pushing member 52 is provided with a wire 521, and the wire 521 is connected to the first flexible wire 235 and the second flexibility of the interatrial stoma device 20
  • the wire 236 is electrically connected.
  • 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 dual-lumen tube 520 is made of polyethylene.
  • the dual-lumen tube 520 includes a first cavity 5201 and a second cavity 2503 that extend axially.
  • 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 one of the wires 521 in the push piece 52
  • the proximal end passes through the wall of the double-lumen tube 520 and is welded to the connecting sleeve 523.
  • the distal end of the wire 521 extends along the second cavity 2503 until it is connected to the output end of the RF power supply.
  • connection portion 237 of the first flexible wire 235 of the ablation member 23 is welded to the outer wall surface of the connection sleeve 523; the connection portion 237 of the second flexible wire 236 is directly electrically connected to another wire 521 in the pushing member 52, so The other wire 521 is connected to the RF power circuit end.
  • the first electrode 231 serves as an ablation electrode
  • the second electrode 233 serves as an electrode connected to the RF power supply circuit end.
  • 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, and 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.
  • connection portion 237 of each of the first flexible wire 235 and the second flexible wire 236 of the ablation member 23 is located between the connection sleeve 523 and the protection tube 527, and the first flexible wire 235 is The second flexible wires 236 are insulated. 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 of 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 connector 562, so that the first electrode 231 is connected to the ablation power supply, and the second electrode is connected to the radio frequency power supply circuit end.
  • 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 closely attached to the surface of the interatrial septum 601 facing the left atrium, and the second electrode 233 is brought into contact with the tissue of the atrial septum 601 good;
  • 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 23 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 expansion part 211 of the interatrial septal ostomy system 100 in this embodiment expands the perforation on the interatrial septum to form a stoma, and the ablation member 23 on the support skeleton 21 can separate the interstitial septum from the tissue near the perforation Isolation is performed to prevent the endothelium crawling near the perforation from blocking the stoma and keeping the stoma open; secondly, since the first electrode 231 and the second electrode 233 are both located on the support skeleton 21 Therefore, the distance between the first electrode 231 and the second electrode 233 is short, and it is easy to control the current distribution of the ablation member 23, that is, the current only passes through the interatrial septum tissue between the first electrode 231 and the second electrode 233.
  • the radio frequency energy can be concentrated in the interatrial septum and released between the first electrode 231 and the second electrode 233, that is, the energy is easy to gather and can cause continuous damage, prevent the radio frequency energy loss on the electrode, improve the ablation efficiency, and prevent the body from other Injury of tissue;
  • the interatrial septal ostomy device 20 can be recovered after the ostomy is completed, that is, the interatrial septal ostomy device 20 does not need to remain on the interatrial septum, thereby preventing the instrument from falling off and forming an embolism.
  • the first electrode 231 may be disposed on the positioning surface 2132 of the first positioning portion 213, and the second electrode 233 may be disposed on the outer wall surface of the spreading portion 211; the first electrode 231 and the second electrode 233 Both can be spaced apart from each other on the positioning surface 2132 of the first positioning portion 213 or the outer wall surface of the spreading portion 211; the second electrode 233 can also be disposed on the outer wall surface of the extension portion 214, and the first electrode 231 can also be disposed on The positioning surface 2132 of the first positioning portion 213 and the outer wall surface of the expansion portion 211.
  • the distal end of the first positioning portion 213 extends radially to form a plurality of positioning rods, and the positioning rods form a cone or a circle.
  • the first electrode 231 and / or the second electrode 233 are disposed on the positioning rod, so that the first electrode 231 and / or the second electrode 233 contact the interatrial septum.
  • the distal end of the first positioning portion 213 extends radially to form a plurality of positioning rods.
  • the positioning rods form a cone or a circle, and the positioning rods are provided with positioning points.
  • the first electrode 231 and / or the second electrode 233 are disposed on several of the positioning points, so that the first electrode 231 and / or the second electrode 233 contact the interatrial septum.
  • the distal end of the first positioning portion 213 extends radially to form a positioning surface, the positioning surface is provided with a number of positioning points, and the first electrode 231 and / or the second electrode 233 are provided for positioning At the point, the first electrode 231 and / or the second electrode 233 are brought into contact with the interatrial septum.
  • FIG. 12 is a schematic structural diagram of an ablation sealing device of an interatrial septal ostomy system according to a second embodiment of the present application.
  • 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 support skeleton 21 is a metal support skeleton, specifically, the support skeleton 21 is The nickel alloy supports the skeleton, and the support skeleton 21 serves as an ablation member 23 connected to the end of the RF power supply circuit.
  • an electrically exposed area is provided on the positioning surface 2132 of the first positioning portion 213, and the outer surface of the support frame 21 is coated with an insulating coating except for the electrically exposed area, and the electrically exposed area As the second electrode 233 of the ablation member 23.
  • the electrically exposed area may be provided on at least one location on the positioning surface 2132.
  • the connecting piece 2152 of the supporting frame 21 is connected to the RF power supply circuit end through the push piece 52 through a wire, so that the electrically exposed area is connected to the RF power supply circuit end, that is, the second electrode 233 is connected to the RF power supply circuit end.
  • each lead 235 is provided with a first electrode 231, the first electrode 231 is glued to the outer wall surface of the spreading portion 211, these first electrodes 231 are provided along the outer wall surface of the spreading portion 211 circumferentially connected or Intermittent at least one lap.
  • the distal end of each wire 235 is electrically connected to the connection sleeve, and then electrically connected to the radio frequency power supply through the wire 521 and the connector 562 of the pusher 52.
  • the first electrode 231 serves as an ablation electrode
  • the second electrode 233 serves as an electrode connected to the RF power supply circuit end.
  • the spreading part 211 is supported in the perforation of the interatrial septum, so that the first electrode 231 contacts the interatrial septum; 233 contacts the interatrial septum; the first electrode 231 and the second electrode 233 form a current loop, current only flows through the tissue of the interatrial septum between the first electrode 233 and the second electrode 233, and the first electrode 231 receives the
  • the energy at the output end of the radio frequency power supply ablate the interatrial septum, inactivate the tissue of the interatrial septum near the perforation, and prevent the perforation from being blocked by tissue repairing endothelial crawling.
  • the electrically exposed area on the positioning surface 2132 of the first positioning portion 213 is at least one circle connected or intermittently arranged along the circumferential direction of the spreading portion 211, and the supporting frame 21 passes through the wires in the pushing member 52 521 is electrically connected to the output end of the RF power supply, that is, the second electrode 233 is electrically connected to the output end of the RF power supply; the first electrode 231 can be connected to the end of the RF power supply circuit through the wire in the pushing member 52, that is, the electrically exposed area serves as an ablation electrode Perform on the interatrial septum.
  • the second electrode 233 is an ablation electrode
  • the first electrode 231 is used as an electrode connected to the RF power supply circuit end.
  • the outer wall surface of the spreading portion 211 is provided with at least one circle of connected or intermittent electrically exposed areas along the circumferential direction, the electrically exposed areas pass through the wires in the support frame 21 and the pushing member 52 It is connected to the RF power supply loop end or electrically connected to the RF power supply output end, that is, the electrically exposed area can be used as both an ablation electrode and an RF power supply loop end electrode.
  • interatrial septal ostomy system When using the interatrial septal ostomy system in this embodiment, it needs to be used in conjunction with a loader, a sheath tube, a sheath core, a conductive pusher, an RF power output end, and a power connection line.
  • a loader When using the interatrial septal ostomy system in this embodiment, it needs to be used in conjunction with a loader, a sheath tube, a sheath core, a conductive pusher, an RF power output end, and a power connection line.
  • the specific use flow and method are the same as those in the first embodiment, and will not be repeated here.
  • FIG. 13 is a schematic structural diagram of an ablation sealing device of an interatrial septostomy system according to a third embodiment of the present application.
  • the structure of the ablation plugging device provided in the third embodiment of the present application is similar to that of the first embodiment, except that in the third embodiment, an insulating film 27 is provided between the support frame 21 and the ablation member 23. Further, the insulating film 27 is located between the first electrode 231 of the ablation member 23 and the support frame 21.
  • the insulating film 27 may be, but not limited to, a polytetrafluoroethylene film, a polyurethane film, or a polyimide film.
  • the first electrode 231 is an ablation electrode
  • the second electrode 233 is an electrode connected to a radio frequency power supply circuit end
  • the first electrode 231 is used to ablate interatrial septal tissue. Since the supporting frame 21 and the first electrode 231 are separated by an insulating film 27, the insulating film 27 can not only isolate the heat conduction between the ablation electrode and the supporting frame 21, that is, prevent energy from being transferred to the support On the skeleton 21, so that heat can be concentrated on the first electrode 231 to ablate the interatrial septum tissue and improve energy utilization; and the insulating film 27 can also form an insulating barrier on the side of the first electrode 231 facing the blood, This reduces the current density through the blood, reduces the heating of the blood by the ablation member 23, and reduces the risk of thrombosis.
  • the insulating film 27 is provided on the outer wall surface of the supporting frame 21 corresponding to the ablation member 23. 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 23 corresponding to the support frame 21, specifically, the insulating film 27 is adhered to the ablation member 23 by adhesive Facing the outer surface of the support frame 21.
  • the area of the ablation member 23 projected onto the insulation film 27 is located in the insulation film 27, that is, the projected area of the ablation member 23 on the insulation film 27 is less than or equal to the area of the insulation film 27, thereby isolating the first electrode 231 from the support frame Heat transfer between 21.
  • the interatrial septal ostomy 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.
  • the specific use flow and method are the same as those in the first embodiment, and will not be repeated here.
  • FIG. 14 is a schematic structural diagram of an ablation sealing device of an interatrial septostomy system according to a fourth embodiment of the present application.
  • the structure of the ablation plugging device provided by the fourth embodiment of the present application is similar to the structure of the third embodiment, except that the structure of the ablation member in the fourth embodiment is different from the third embodiment, in the fourth embodiment
  • the first electrode 231a of the ablation member 23 of the ablation plugging device 20 includes a plurality of spaced dot-shaped electrodes, and these dot-shaped electrodes are arranged at least one turn along the circumferential direction of the outer wall surface of the support frame 21.
  • these dot-shaped electrodes are arranged one circle along the outer wall surface of the spreading portion 211, and the first electrode 231a 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 insulating film 27 is provided between the ablation member 23 and the support frame 21 on the outer wall surface of the wire wrapped around the support frame 12.
  • 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 wire 235 through a wire in series, and the flexible wire 235 passes through the connector 2152, the connection sleeve 523, and The wire in the push piece is electrically connected to the radio frequency power supply.
  • the interatrial septal ostomy 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.
  • the specific use flow and method are the same as those in the third embodiment, and will not be repeated here.
  • the expansion part 211 of the interatrial septal ostomy device 20 in this embodiment expands the perforation in the interatrial septum to form a stoma.
  • the first electrode 231a of the ablation member 23 on the expansion part 211 can change the inner wall of the perforation
  • the tissues are separated to prevent the endothelium crawling near the perforation from blocking the perforation, preventing the perforation from blocking, and keeping the perforation smooth;
  • the insulating film 27 can also be placed on the first electrode 231a of the ablation member 23
  • An insulating barrier is formed on the side facing the blood, thereby reducing the current density through the blood, reducing the heating of the blood by the first electrode 231a, and reducing the risk of thrombosis.
  • the atrial septostomy device 20 is completing the ostomy It can be recovered afterwards, that is, the interatrial septal ostomy device 20 does not need to remain in the interatrial septum, thereby preventing the device from falling off and forming an embolism; and, the current of the ablation member 23 only flows between the first electrode 231a and the second electrode 233
  • the interatrial septum prevents the loss of radio frequency energy on the electrodes, improves the ablation efficiency, and prevents damage to other tissues of the body.
  • FIG. 15 is a schematic structural diagram of an ablation sealing device of an interatrial septal ostomy system according to a fifth embodiment of the present application.
  • the structure of the ablation sealing device provided by the fifth embodiment of the present application is similar to the structure of the third embodiment, except that the structure of the ablation member in the fifth embodiment is different from the third embodiment.
  • the first electrode 231b of the ablation member 23 of the ablation sealing device 20 is a single-ring intermittent ring-shaped electrode provided in the circumferential direction of the outer wall of the support frame 21, and the ring electrode is insulated from the support frame 21.
  • 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-shaped electrode is electrically connected to the wire 235 through a wire in series, and the wire 235 is connected to the output terminal of the radio frequency power supply through the connecting sleeve 523 and the wire 521 in the pushing member 52.
  • 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 first electrode 231c of the ablation member 23 may be a single-ring uninterrupted ring-shaped electrode disposed in the circumferential direction of the outer wall of the support frame 21, and the ring-shaped electrode is connected to the output terminal of the RF power supply through a wire.
  • FIG. 16 is a schematic structural diagram of an ablation sealing device of an interatrial septal ostomy system according to a sixth embodiment of the present application.
  • the structure of the ablation plugging device provided in the sixth embodiment of the present application is similar to the structure of the third embodiment, except that the structure of the ablation member in the sixth embodiment is different from the third embodiment, in the sixth embodiment
  • the first electrode 231c of the ablation member 23 includes a plurality of spaced rod-shaped electrodes, each rod-shaped electrode extends along the axial direction of the support frame 21, and these rod-shaped electrodes are arranged at least one turn along the circumference of the outer wall surface of the support frame 21 .
  • these rod-shaped electrodes are arranged at least once along the outer wall surface of the spreading portion 211, and the ablation member 23 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 27 is provided between the ablation member 23 and the support frame 21 on the outer wall surface of the 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 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. 17 is a schematic structural diagram of an ablation sealing device of an interatrial septal ostomy system according to a seventh embodiment of the present application.
  • the structure of the ablation sealing device provided in the seventh embodiment of the present application is similar to the structure of the first embodiment, except that in the seventh embodiment, the support skeleton 21 is a metal support skeleton.
  • the support skeleton 21 is The self-expanding nickel alloy stent, the interatrial ostomy device 20 is fully released, and the interatrial ostomy device 20 also includes a cylindrical expansion portion 211, a first positioning portion 213, an extension portion 214, and a recovery portion 215, wherein the first positioning portion 213 is located at one end of the expansion portion 211, and the extension portion 214 is located at the end of the expansion 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 first electrode 231d of the ablation member 23 in this embodiment is a ring-shaped electrode provided on the positioning surface 2132 of the first positioning portion 213.
  • the ring-shaped electrode surrounds a circle along the circumferential direction of the spreading portion 211.
  • a gap is provided in the radial direction with the spreading part 211, specifically, the radial distance between the ring electrode and the spreading part 211 can be set to 0-5 mm, preferably 3 mm; the second electrode 233a is along the spreading part 211
  • the outer wall surface surrounds at least one ring electrode.
  • the first electrode 231d is electrically connected to the positioning member 2155 through a flexible wire 238.
  • the flexible wire 238 is located in the support frame 21, one end of the flexible wire 238 passes through the support frame 21 and is welded to the first electrode 231d, and the other end of the flexible wire 238 is welded to the positioning member 2155,
  • the positioning member 2155 is electrically connected to the output end of the radio frequency power supply through the wire in the pushing member 52.
  • the second electrode 233a is connected to the RF power supply loop end through another flexible wire 238.
  • both the first electrode 231d and the second electrode 233a are a continuous ring-shaped, highly elastic and flexible metal wire.
  • the first electrode 231d and the second electrode 233a may be attached to the support frame 21 by stitching and / or binding.
  • 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 238 remote from the ablation member 23 passes through the threading hole directly It is electrically connected to the output end of the RF power supply or the loop end of the RF power supply.
  • the support frame 21 is provided with at least one circle of development marks 2114 circumferentially on the outer wall surface of the spreading portion 211. Specifically, a plurality of through holes 2112 are formed on the expansion portion 211 adjacent to the ablation member 23, and these through holes 2112 are arranged in a circle along the circumferential direction of the expansion portion 211. The proximal ends of the two flexible wires 23 respectively pass through the two through holes 2112 and are electrically connected to the first electrode 231d and the second electrode 233a. 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 side surface of the circular single-layer planar structure facing the expansion portion 211 is a positioning surface 2132.
  • 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 inner and outer surfaces of the support frame 21 are coated with an insulating layer, such as a Parylene insulating coating, so as to insulate the first electrode 231d and the second electrode 233a from the support frame 21 from each other.
  • an insulating film 27 is provided between the ablation member 23 and the support frame 21. Specifically, the insulating film 27 is provided in a ring structure.
  • the insulating film 27 includes a first ring-shaped insulating film covering the first positioning portion 213 adjacent to the expansion portion 211 and covering the expansion portion 211 adjacent to the first positioning portion The second ring-shaped insulating film at 213 places.
  • the ablation member 23 and the support skeleton 21 can be isolated, not only can the heat conduction between the ablation member 23 and the support skeleton 21 be isolated, the energy is prevented from being transferred to the support skeleton 21, and the energy is concentrated on the first electrode 231d ,
  • the insulating film 27 can form an insulating barrier on the side of the ablation member 23 facing the blood, reducing the current density through the blood, Reduces the heating of blood by the current and reduces the risk of thrombosis; in addition, the current of the ablation member 23 only flows through the interatrial septum between the first electrode 231d and the second electrode 233a, preventing the loss of radio frequency energy on the electrode and improving ablation Efficiency and prevent damage to other tissues of the body.
  • the insulating film 27 may only include the first annular insulating film covering the first positioning portion 213 adjacent to the expansion portion 211, that is, the insulating film 27 may omit the second annular insulating film.
  • the first annular insulating film is used to isolate the first electrode 231d 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. Specifically, the positioning member 2155 is connected to the pushing member through the screw hole 2157.
  • the wire in the pushing member is electrically connected to the positioning member 2155, so that the first electrode 231d is electrically connected to the output end of the RF power supply through the flexible wire 238, the positioning member 2155 and the wire in the pushing member; connected to the second electrode 233a
  • the upper flexible wire 238 is connected to the radio frequency power supply circuit end through the pushing piece.
  • the interatrial septal ostomy 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.
  • the specific use flow and method are the same as those in the first embodiment, and will not be repeated here.
  • the first electrode 231d may be a ring-shaped electrode disposed at least once around the expansion portion 211 on the outer wall surface of the expansion portion 211, the first electrode 231d and the expansion portion 211 An insulating film 27 is provided between the outer wall surfaces of.
  • the first electrode 231d may be a wave-shaped ring electrode surrounding at least one turn on the outer wall surface of the expansion portion 211 and the positioning surface 2132 of the first positioning portion 213 around the expansion portion 211 That is, part of the wave-shaped ring electrode is located on the outer wall surface of the spreading portion 211, and the other part is located on the positioning surface 2132 of the first positioning portion 213, the first electrode 231d and the spreading portion 211 and An insulating film 27 is provided between the outer wall surfaces of the first positioning portion 213.
  • FIG. 18 is a schematic structural view of an interatrial septal ostomy system provided in an eighth embodiment of the present application
  • FIG. 19 is a structure of an insulation film added to the ablation sealing device of the interatrial septal ostomy system in FIG. schematic diagram.
  • the structure of the interatrial septal ostomy system provided in the eighth embodiment of the present application is similar to the structure of the first embodiment, except that in the eighth embodiment, the atrial septal ostomy device 20 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 217 provided at the opposite end of the expansion portion 211;
  • the proximal end of a positioning portion 213a is connected to the spreading portion 211, and the distal end extends and merges along the axial direction of the spreading portion 211;
  • the proximal end of the second positioning portion 217 is connected to the spreading portion 211, far The ends extend along the axial direction of the spreading portion 211 and merge.
  • the support skeleton 21a is a metal support skeleton.
  • the support skeleton 21a is a self-expanding nickel alloy stent.
  • the support frame 21a is a braided mesh nickel-titanium alloy stent.
  • the diameter of the support frame 21a can be contracted to a smaller state for delivery in the sheath tube;
  • 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 attached to the surface of the interatrial septum facing the left atrium
  • the second positioning portion 217 is located in the right atrium and is attached to the atrial septum facing away from the left atrium The surface 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 extending radially from an end edge of the spreading portion 211 to form a planar or nearly planar conical or arc-shaped surface, and connected to the positioning surface 2132
  • the first thrombus catching cage 2133 at the 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 The top rod 2136.
  • the first positioning portion 213a is located in the left atrium and the positioning surface 2132 is fitted to the interatrial septum, and the outer surface of the first thrombosis cage 2133 does not abut the interatrial septum.
  • the ejector rod 2136 is used for the ejector rod 2136 to smoothly pass through the perforation in the interatrial septum when the interatrial septal ostomy device 20 is implanted.
  • the second positioning portion 217 includes a positioning surface 2172 radially extending from an end edge of the spreading portion 211 to form a planar or nearly planar conical or arc-shaped surface, and connected to the positioning surface 2172 A second thrombus catching cage 2173 at the edge and extending toward the end away from the spreading portion 211.
  • 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, and the distal ends of the second closing surface 2175 merge into one Cone top 2176.
  • the second positioning portion 217 is located in the right atrium and the positioning surface 2172 fits the atrial septum, and the outer surface of the second thrombosis cage 2173 does not abut the atrial septum.
  • the cone tip 2176 is used to connect the proximal end of the pusher 52a.
  • the ablation member 23 includes a first electrode 231f provided on the spreading portion 211, and a second electrode 233b provided on the second positioning portion 217.
  • the first electrode 231f is a ring electrode connected or spaced at least one circle along the circumferential direction of the spreading portion 211
  • the second electrode 233b is disposed on the positioning surface 2172 of the second positioning portion 217
  • the spreading portion 211 is circumferentially provided with at least one ring of connected or spaced ring electrodes.
  • the first electrode 231f on the spreading part 211 is a continuous ring of ring electrodes; the second electrode 233b is also a continuous ring of ring electrodes, and the ring electrode and the spreading part 211 are provided with a gap in the radial direction Specifically, the radial distance between the second electrode 233b 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. Both the first electrode 231f and the second electrode 233b are stitched or glued to the support frame 21 by sutures.
  • Each ablation member 23 and the support frame 21a are insulated from each other. 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 23 and the support frame 21a are insulated from each other.
  • an insulating layer such as a Parylene insulating coating
  • the proximal end of the second positioning portion 217 extends radially to form a plurality of positioning rods, and the positioning rods form a cone or a circle.
  • the first electrode 231f and / or the second electrode 233b are disposed on the positioning rod, so that the first electrode 231f and / or the second electrode 233b contact the interatrial septum.
  • the proximal end of the second positioning portion 217 extends radially to form a plurality of positioning rods, and the positioning rods form a cone or a circle, and the positioning rods are provided with positioning points.
  • the first electrode 231f and / or the second electrode 233b are disposed at a plurality of the positioning points, so that the first electrode 231f and / or the second electrode 233b contact the interatrial septum.
  • the proximal end of the second positioning portion 217 extends radially to form a positioning surface, the positioning surface is provided with a plurality of positioning points, and the first electrode 231f and / or the second electrode 233b are disposed at the positioning At the point, the first electrode 231f and / or the second electrode 233b are brought into contact with the interatrial septum.
  • an insulating film 27 is provided between the outer wall surface of the spreading portion 211 and the first electrode 231f, and an insulating film is also provided between the positioning surface 2172 of the second positioning portion 217 and the second electrode 233b 27; the insulating film 27 on the expansion portion 211 covers the outer wall surface of the expansion portion 211 a week, the insulating film 27 on the positioning surface 2172 of the second positioning portion 217 covers the positioning surface 2172 of the second positioning portion 217 a week , And extends to the second thrombosis 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 23 and the support skeleton 21a can be isolated, not only can the heat conduction between the ablation member 23 and the support skeleton 21a be isolated, and energy can be prevented from being transferred to the support skeleton 21a, thereby concentrating energy on the ablation member 23,
  • 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 the blood reduces the heating of the blood by the current and reduces the risk of thrombosis; in addition, the distance between the first electrode 231f and the second electrode 233b is short, and it is easy to control
  • Both the first electrode 231f and the second electrode 233b are electrically connected to the output end of the RF power supply or the end of the RF power supply through the wire 521, and the outer surface of the wire 521 is insulated. Specifically, one end of the wire 521 is connected to the first electrode 231f or the second electrode 233b by welding, and the other end of the wire 521 is connected to the radio frequency power supply via the second thrombus catch cage 2173, cone tip 2176, and the pushing member 52a The output end may be connected to the RF power supply loop end.
  • the polarity selection of the first electrode 231f and the second electrode 233b includes but is not limited to the following two schemes:
  • the first electrode 231f is connected to the RF output port through the wire 521, and the second electrode 233b is connected to the RF power supply circuit end through the wire 521, without a neutral electrode plate. At this time, the first electrode 231f serves as an ablation electrode, and the second electrode 233b serves as a terminal electrode connected to the RF power supply circuit (the electrode connected to the RF power supply circuit may also be referred to as a ground electrode).
  • the second electrode 233b is connected to the RF output port through the wire 521, and the first electrode 231f is connected to the RF power supply circuit end through the wire 521, without a neutral electrode plate. At this time, at this time, the second electrode 233b serves as an ablation electrode, and the first electrode 231f serves as an electrode connected to the RF power supply circuit end.
  • the expansion portion 211 expands the perforation of the interatrial septum to form a ostomy; the first thrombus grasping cage 2133 is deployed in the left atrium, and the positioning surface 2132 is attached to Interatrial septum; the second thrombosis cage 2173 is deployed in the right atrium, and the positioning surface 2172 is attached to the interatrial septum to cover the three-dimensional space area near the heating area of the interatrial septum to prevent blood from entering due to heating. Circulatory system to prevent embolism.
  • the pushing member 52a is made of an insulating polymer material, and the cone tip 2176 of the second positioning portion 217 of the interatrial ostomy device 20 and the proximal end of the pushing member body are connected by hot melt or adhesive.
  • a threading hole is axially opened in the pushing member 52a.
  • the wire 521 extends to the tail end through the threading hole in the pushing member 52a and is electrically connected to the tail connector 562.
  • the connector 562 is used to electrically connect the radio frequency power supply.
  • the interatrial septostomy device 20 in this embodiment When the interatrial septostomy device 20 in this embodiment is used, it needs to be used in combination with a loader, a sheath tube, a sheath core, a radio frequency power supply, and a power connection cable.
  • 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.
  • interstitial stoma device 20 of appropriate size. Pass the pusher from the proximal end of the loader, and connect the distal end of the interatrial septostomy device 20 to the proximal end of the pusher. The retractor pushes the interatrial septostomy device 20 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 inner and positioning surface 2172 clings to the surface of the interatrial septum facing away from the left atrium.
  • the distal end of the pusher After confirming that the first electrode 231f on the spreading part 211 and the second electrode 233b on 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 20 can be recovered to the sheath and removed from the body, and it is measured whether the diameter of the ostomy is as expected.
  • FIG. 20 is a schematic structural diagram of an interatrial septostomy system provided in a ninth embodiment of the present application.
  • the structure of the atrial septostomy system provided in the ninth embodiment of the present application is similar to that of the eighth embodiment, except that in the ninth embodiment, the first electrode 231f of the atrial septostomy device 20 is provided at the first On a positioning portion 213a, the second electrode 233b is disposed on the spreading portion 211.
  • the first electrode 231f is provided on the positioning surface 2132 of the first positioning portion 213a with at least one ring of connected or spaced ring electrodes along the circumferential direction of the expansion portion 211, and the second electrode 233b is circumferentially arranged on the expansion portion 211 At least one ring of connected or spaced ring electrodes is provided.
  • the first electrode 231f is a continuous ring electrode disposed on the positioning surface 2132.
  • the ring electrode and the spreading portion 211 are provided with a gap in the radial direction.
  • the ring electrode and the spreading portion The radial distance of 211 can be set to 0-5mm, preferably 3mm;
  • the second electrode 233b is a ring-shaped electrode arranged on the spreading part 211 in a continuous circle;
  • each ring-shaped electrode is a flexible metal wire with high elasticity Or metal sheet, such as nickel-titanium multi-strand wire, or gold spring-coated nickel-titanium multi-strand wire and other structures.
  • Both the first electrode 231f and the second electrode 233b are stitched or glued to the support frame 21a with stitches.
  • the first electrode 231f may be electrically connected to the output terminal of the RF power supply through the wire 521, the second electrode 233b is connected to the RF power supply circuit end through the wire 521, at this time, the first electrode 231f serves as an ablation electrode, and the second electrode 233b serves as a connection to the RF power supply circuit Terminal electrode; or the second electrode 233b can be electrically connected to the output end of the RF power supply through the wire 521, the first electrode 231f is connected to the RF power supply circuit end through the wire 421, the second electrode 233b is used as an ablation electrode, and the first electrode 231f is used to connect the RF power supply Loop end electrode.
  • An insulating film 27 is provided between the outer wall surface of the spreading portion 211 and the corresponding second electrode 233b, and an insulating film 27 is also provided between the positioning surface 2132 of the first positioning portion 213a and the corresponding first electrode 231f.
  • the insulating film 27 on the outer wall surface of the first positioning portion 213a covers the positioning surface 2132 for one round, and extends onto the first thrombus catching cage 2133.
  • the insulating film 27 on the spreading portion 211 and the insulating film 27 on the positioning surface 2132 of the first positioning portion 213a may be two separate insulating films or may be combined into one insulating film.
  • the ablation member 23 and the support skeleton 21a can be isolated, not only can the heat conduction between the ablation member 23 and the support skeleton 21a be isolated, and energy can be prevented from being transferred to the support skeleton 21a, thereby concentrating energy on the ablation member 23,
  • 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 the blood reduces the heating of the blood by the current and reduces the risk of thrombosis; in addition, the distance between the first electrode 231f and the second electrode 233b is short, and it is easy to control the current distribution of the ablation member 23, that is, the current Only the tissue flowing through the interatrial septum between the first electrode 231f and the second electrode 233b can prevent the current from damaging other tissues of the human body.
  • the interatrial septal ostomy 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.
  • the specific use flow and method are the same as those in the sixth embodiment, and will not be repeated here.
  • FIG. 21 is a schematic structural diagram of an interatrial septostomy system provided in a tenth embodiment of the present application.
  • the structure of the atrial septostomy system provided in the tenth embodiment of the present application is similar to that of the eighth embodiment, except that in the tenth embodiment, the first electrode of the ablation member 23 of the atrial septostomy device 20 231f is provided on the first positioning portion 213a, and the second electrode 233b is provided on the second positioning portion 217.
  • the first electrode 231f is provided on the positioning surface 2132 of the first positioning portion 213a with at least one ring of connected or spaced ring electrodes along the circumferential direction of the spreading portion 211, and the second electrode 233b is located on the second positioning portion 217
  • the positioning surface 2172 is provided with at least one ring of connected or spaced ring electrodes along the circumferential direction of the spreading portion 211.
  • the first electrode 231f is a ring-shaped electrode disposed on the positioning surface 2132 of the first positioning portion 213a and continuous around the expansion portion 211 in the circumferential direction.
  • the ring electrode and the expansion portion 211 are arranged in the radial direction There is a gap.
  • the radial distance between the ring electrode and the spreading portion 211 may be set to 0-5 mm, preferably 3 mm.
  • the second electrode 233b is a ring-shaped electrode provided on the positioning surface 2172 of the second positioning portion 217 and continuous around the expansion portion 211 circumferentially.
  • the ring electrode and the expansion portion 211 are provided with a gap in the radial direction.
  • 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.
  • Both the first electrode 231f and the second electrode 233b are stitched or glued to the support frame 21a with stitches.
  • the first electrode 231f is electrically connected to the output terminal of the RF power supply through a wire
  • the second electrode 233b is connected to the RF power supply circuit end through a wire
  • the first electrode 231f serves as an ablation electrode
  • the second electrode 233b serves as an electrode connected to the RF power supply circuit end
  • the electrode 233b is electrically connected to the output terminal of the RF power supply through a wire
  • the first electrode 231f is connected to the RF power supply circuit end through a wire
  • the second electrode 233b serves as an ablation electrode
  • the first electrode 231f serves as an electrode connected to the RF power supply circuit end.
  • an insulating film 27 is provided between the positioning surface 2132 of the first positioning portion 213a and the first electrode 231f; an insulating film 27 is also provided between the positioning surface 2172 of the second positioning portion 217 and the second electrode 233b.
  • An insulation 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; in addition, the distance between the first electrode 231f and the second electrode 233b is short, which is easy to control the ablation
  • the distribution of the current of 23, that is, the current only flows through the interatrial tissue between the first electrode 231f and the second electrode 233b, can prevent the current from damaging other tissues of the human body, and can concentrate radio frequency energy for ablation Part 23, to achieve a better ablation effect.
  • the interatrial septal ostomy 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.
  • the specific use flow and method are the same as those in the sixth embodiment, and will not be repeated here.
  • 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. 22 is a schematic structural diagram of an interatrial septal ostomy system provided in an eleventh embodiment of the present application.
  • FIG. 23 is an ablation sealing device of the interatrial septal ostomy system in FIG. Structure diagram;
  • FIG. 24 is a cross-sectional view taken along line XXIV-XXIV in FIG. 23;
  • FIG. 25 is an enlarged view of the XXV part in FIG. 24.
  • the structure of the interatrial septal ostomy system provided in the eleventh embodiment of the present application is similar to the structure of the eighth embodiment, except that in the eleventh embodiment, in a state where the interatrial septal ostomy device 20 is completely released ,
  • the support frame 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 provided at the opposite end of the expansion portion 211 217a.
  • 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 is spread along The axial direction of the portion 211 extends and merges.
  • the support framework 21b is a metal support framework. Specifically, the support framework 21b is a self-expanding nickel alloy stent.
  • the support frame 21b is a braided mesh nickel-titanium alloy bracket
  • the first positioning portion 213b is a single-layer braided mesh structure
  • the second positioning portion 217a is a double-layer braided mesh structure.
  • the diameter of the support skeleton 21b can be contracted 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 expand
  • the portion 211 can produce a certain radial support effect on the perforated inner wall tissue of the interatrial septum with which it contacts, and can expand the perforation of the interatrial septum to form a stoma;
  • the first positioning portion 213b is located in the left atrium and fits to the atrium The septum faces the surface of the left atrium, and the second positioning portion 217a is located in the right atrium and is attached to the surface of the interatrial septum facing away from the left atrium, thereby positioning the expansion portion 211 in the stoma of the atrial septum.
  • the first positioning portion 213b 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 and merged on a cone top 2176.
  • the cone tip 2176 is used to connect the proximal end of the pushing member 52a.
  • the ablation member 23 in this embodiment includes a first electrode 231f provided on the positioning surface 2172 of the second positioning portion 217a, and a second electrode 233b provided on the positioning surface 2132 of the first positioning portion 213b.
  • the first electrode 231f is a ring electrode connected or spaced at least one circle along the circumferential direction of the spreading portion 211, and the ring electrode and the spreading portion 211 are provided with a gap in the radial direction.
  • the ring electrode The radial distance from the spreading portion 211 may be set to 0-5 mm, preferably 3 mm.
  • the first electrode 231f is a flexible metal wire or metal sheet with high elasticity, such as a nickel-titanium multi-strand wire or a gold-spring-coated nickel-titanium multi-strand wire.
  • the first electrode 231f is stitched or glued to the positioning surface 2172 of the second positioning portion 217a by a suture.
  • the second electrode 233b is an electrically exposed area provided on the positioning surface 2132, that is, the nickel-titanium alloy supporting the skeleton 21b is not coated with an insulating coating on the positioning surface 2132 corresponding to the second electrode 233b.
  • the positioning surface 2132 The electrically exposed nitinol region may be connected or spaced at least one turn along the circumferential direction of the spreading portion 211.
  • the second electrode 233b is a ring-shaped electrically-exposed ring-shaped nickel-titanium region that is circumferentially connected along the spreading portion 211, and the ring-shaped nickel-titanium alloy region and the spreading portion 211 are in the radial direction A gap is provided, and a specific radial distance between the annular nickel-titanium alloy region and the spreading portion 211 may be set to 0-5 mm, preferably 3 mm.
  • the first electrode 231f is electrically connected to the output end of the RF 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 first electrode 231f by welding, and the other end of the wire 521 is connected to the output end of the RF power source through the second positioning portion 217a, the cone tip 2176, the pushing member 52a and the connector 562.
  • the second electrode 233b is connected to the end of the RF power supply circuit through a wire 521.
  • one end of the 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 end of the wire is connected to the RF power circuit end via the pushing member 52a and the connector 562.
  • the first electrode 231f serves as an ablation electrode
  • the second electrode 233b serves as an electrode connected to the RF power supply circuit end.
  • the first electrode 231f is connected to the RF power supply circuit end through the wire 521
  • the second electrode 233b is electrically connected to the RF power supply output end through the wire 521.
  • the outer surface of the wire 521 is insulated, one end of the wire 521 is connected to the first electrode 231f by welding, the other end of the wire 521 is connected to the radio frequency through the second positioning portion 217a, the cone top 2176, the pushing member 52a and the connector 562 Power circuit end; 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 end of the wire 521 is connected to the radio frequency power supply via the pusher 52a and the connector 562 Output.
  • the second electrode 233b serves as an ablation electrode
  • the first electrode 231f serves as an electrode connected to the RF power supply circuit end.
  • a plurality of positioning points are provided on the positioning surface 2132, and these positioning points are set as electrically exposed areas.
  • the proximal end of the first positioning portion 213b extends radially to form a plurality of positioning rods, and the positioning rods are conical or circular. The surface of these positioning rods contacting the interatrial septum provides an electrically exposed area.
  • the proximal end of the first positioning portion 213b extends radially to form a plurality of positioning rods, and a plurality of positioning points are provided on the positioning rods, and these positioning points are configured as electrically exposed areas.
  • the ablation member 23 and the supporting frame 21b are insulated from each other. Specifically, all surfaces of the supporting frame 21b except the second electrode 233b are coated with an insulating coating, such as Parylene insulation The coating layer insulates the ablation member 23 and the support frame 21b from each other. Furthermore, the outer wall surface of the second positioning portion 217a is entirely covered with an insulating film 27 that insulates the first electrode 231f from the support frame 21b.
  • an insulating coating such as Parylene insulation
  • the side of the first positioning portion 213b facing away from the spreading portion 211 is coated with an insulating coating corresponding to the second electrode 233b, and the insulating coating may be, but not limited to, Parylene coating, PTFE Vinyl coating, polyurethane coating, or polyimide coating.
  • the first electrode 231f and the support frame 21b can be isolated, not only can the heat conduction between the ablation member 23 and the support frame 21b be isolated, preventing energy from being transferred to the support frame 21b, thereby concentrating the energy on the ablation member 23
  • the insulating film 27 and insulating coating can An insulating barrier is formed on the side facing the blood, reducing the current density through the blood, reducing the heating of the blood by the current, and reducing the risk of thrombosis; in addition, the current only flows between the first electrode 231f and the second electrode 233b
  • the tissues in the room can prevent the current from damaging other tissues of the human body, and can concentrate the radio frequency energy for the ablation member 23 for ablation to achieve a better ablation effect.
  • an area of the side of the first positioning portion 213b facing away from the spreading portion 211 corresponding to the second electrode 233b is provided with an insulating film, the insulating film is stitched or glued to the support by stitching On the skeleton.
  • the polarity selection of the first electrode 231f and the second electrode 233b in this embodiment includes but is not limited to the following two schemes:
  • the first electrode 231f is connected to the RF output port through the wire 521, and the second electrode 233b is connected to the RF power supply circuit end through the wire 521, without a neutral electrode plate. At this time, the first electrode 231f serves as an ablation electrode, and the second electrode 233b serves as an electrode connected to the RF power supply circuit end.
  • the second electrode 233b is connected to the radio frequency output port through the wire 521, and the first electrode 231f is connected to the radio frequency power supply circuit end through the wire, without a neutral electrode plate. At this time, the second electrode 233b serves as an ablation electrode, and the first electrode 231f serves as an electrode connected to the RF power supply circuit end.
  • the interatrial septal ostomy system in this embodiment needs to be used in conjunction with a loader, a sheath tube, a sheath core, a conductive pusher, an RF power output end and a power connection line, and a neutral electrode plate.
  • the specific use flow and method are the same as those in the sixth embodiment, and will not be repeated here.
  • FIG. 26 is a schematic structural diagram of the interatrial septal ostomy system provided in the twelfth embodiment of the present application.
  • FIG. 27 is an ablation sealing device of the interatrial septal ostomy system in FIG. Schematic.
  • the support skeleton 21c includes a circle A cylindrical expansion part 211, a first positioning part 213c provided at one end of the expansion part 211, and a second positioning part 217b provided at the opposite end of the expansion part 211; the first positioning part The proximal end of 213c is connected to the spreading portion 211, and the distal end extends and merges in the axial direction of the spreading portion 211; the proximal end of the second positioning portion 217 is connected to the spreading portion 211, and the distal end extends along the stretch The axial direction of the opening portion 211 extends and merges.
  • the first positioning portion 213c and the second positioning portion 217b are both double-layer woven mesh structures.
  • the support skeleton 21c is a braided mesh nickel-titanium alloy stent.
  • the diameter of the support skeleton 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 and away from the spreading surface A conical first thrombus catching cage 2133 extending at one end of the 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 catching cage 2133 converges on a plunger 2136, and the plunger 2136 is used for the plunger 2136 to smoothly pass through the interatrial septum when the atrial septostomy device 20 is implanted On the hole.
  • 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.
  • the ablation member 23 includes two first electrodes 231f and one second electrode 233b.
  • the two first electrodes 231f are respectively disposed on the positioning surface 2132 of the first positioning portion 213c and the positioning surface of the second positioning portion 217b 2172, the second electrode 233b is disposed on the outer wall surface of the spreading portion 211.
  • the first electrode 231f on the positioning surface 2132 of the first positioning portion 213c is an electrically exposed area provided on the positioning surface 2132 of the supporting frame 21c, that is, the outer surface of the supporting frame 21c is removed from the electrically exposed area An insulating coating is applied outside the area, and the electrically exposed area on the positioning surface 2132 is connected or spaced at least one turn along the circumferential direction of the spreading portion 211.
  • the first electrode 231f on the first positioning portion 213c is provided in a circle connected along the circumferential direction of the expansion portion 211, and the radial distance between the first electrode 231f and the expansion portion 211 can be set to 0-5 mm. It is preferably set to 3 mm.
  • the first electrode 231f on the positioning surface 2172 of the second positioning portion 217b is an electrically exposed area provided on the positioning surface 2172 of the supporting frame 21c, that is, the outer surface of the supporting frame 21c except the electrically exposed area An insulating coating is applied, and the electrically exposed areas on the positioning surface 2172 are connected or spaced at least one turn along the circumferential direction of the spreading portion 211.
  • the first electrode 231f on the second positioning portion 217b is circumferentially connected along the expansion portion 211, and the radial distance between the first electrode 231f and the expansion portion 211 can be set to 0 ⁇ 5mm, preferably 3mm.
  • the second electrode 233b on the spreading portion 211 is a ring electrode connected or spaced at least one ring along the circumferential direction of the spreading portion 211. Specifically, the second electrode 233b is a continuous ring electrode.
  • the ring electrode is a flexible metal wire or metal sheet with high elasticity, such as a nickel-titanium multi-strand wire or a gold-spring-coated nickel-titanium multi-strand wire.
  • the second electrode 233b is stitched or glued to the support frame 21c by sutures.
  • the two first electrodes 231f are electrically connected to the output end of the RF power source through a wire 521. Specifically, one end of the 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 521 is connected to the output end of the RF power supply via the pushing member 52.
  • the second electrode 233b is connected to the end of the RF power supply circuit through another wire 521. Specifically, one end of the wire 521 is connected to the second electrode 233b by welding, and the other end of the wire 521 is caught by the second thrombosis cage 2173, cone tip 2176, The pusher 52a and the connector 562 are connected to the RF power circuit end. At this time, the two first electrodes 231f are both ablation electrodes, and the second electrodes 233b are electrodes connected to the RF power supply circuit end.
  • interatrial septal ostomy system When using the interatrial septal ostomy system in this embodiment, it needs to be used in conjunction with a loader, a sheath tube, a sheath core, a conductive pusher, an RF power output end, and a power connection line.
  • a loader When using the interatrial septal ostomy system in this embodiment, it needs to be used in conjunction with a loader, a sheath tube, a sheath core, a conductive pusher, an RF power output end, and a power connection line.
  • the specific use flow and method are the same as those in the sixth embodiment, and will not be repeated here.
  • the two first electrodes 231f are connected to the end of the RF power supply circuit through a wire 521.
  • one end of the wire 521 is welded to the cone top 2176 of the support frame 21c to electrically connect the support frame 21c to the wire 521,
  • the other end of the wire is connected to the end of the RF power circuit via the pusher 52.
  • the second electrode 233b is connected to the output end of the RF power supply through another wire 521.
  • one end of the wire 521 is connected to the second electrode 233b by welding, and the other end of the wire 521 is caught by the second thrombus catching cage 2173 and the cone top 2176
  • the pusher 52a and the connector 562 are connected to the output end of the RF power supply.
  • the two first electrodes 231f are both electrodes connected to the RF power circuit end, and the second electrodes 233b are ablation electrodes.
  • a plurality of positioning points are provided on the positioning surface 2172, and these positioning points are set as electrically exposed areas.
  • the proximal end of the second positioning portion 217b radially extends radially to form a plurality of positioning rods, and a plurality of the positioning rods surround a cone or a circle. The surface of these positioning rods contacting the interatrial septum provides an electrically exposed area.
  • the proximal end of the second positioning portion 217b extends radially to form a plurality of positioning rods, and a plurality of positioning points are provided on the positioning rods, and these positioning points are set as electrically exposed areas.
  • an insulating film 27 is provided between the stretched portion 211 and the second electrode 233b, that is, the insulating film 27 covers the outer wall surface of the stretched portion 211 all the way around, so that the insulating film 27 connects the second electrode 233b to
  • the support frame 21c is insulated.
  • 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 first electrode 231f, and the insulating coating may be, but not limited to, parylene coating, polytetrafluoroethylene Vinyl fluoride coating, polyurethane coating, or polyimide coating.
  • FIG. 28 is a schematic structural diagram of an interatrial septal ostomy system provided in a thirteenth embodiment of the present application.
  • the structure of the atrial septal ostomy system provided in the thirteenth embodiment of the present application is similar to the structure of the eighth embodiment, except that the thirteenth embodiment is provided with three electrodes, and three of the electrodes may include two The first electrode 231f and one second electrode 233b, or two second electrodes 233b and one first electrode 231f.
  • the first electrode 231f and the second electrode 233b may simultaneously provide one of the outer wall surface of the spreading portion 211, the positioning surface 2132 of the first positioning portion 213a, and the positioning surface 2172 of the second positioning portion 217 Upper; the first electrode 231f and the second electrode 233b may also be provided on the outer wall surface of the spreading portion 211, the positioning surface 2132 of the first positioning portion 213a, the positioning surface 2172 of the second positioning portion 217
  • the three electrodes can also be provided on the outer wall surface of the spreading portion 211, the positioning surface 2132 of the first positioning portion 213a, and the positioning surface 2172 of the second positioning portion 217, respectively.
  • the ablation member 23 includes two first electrodes 231f and one second electrode 233b.
  • the two first electrodes 231f are respectively disposed on the positioning surface 2132 of the first positioning portion 213a and the outer wall surface of the spreading portion 211
  • the second electrode 233b is provided on the positioning surface 2172 of the second positioning portion 217.
  • the first electrode 231f on the positioning surface 2132 of the first positioning portion 213a is a ring electrode connected or spaced on the positioning surface 2132 and provided with at least one turn along the circumferential direction of the expansion portion 211;
  • the first electrode 231f is a ring electrode connected or spaced at least one circle along the circumferential direction of the spreading portion 211;
  • the second electrode 233b of the positioning surface 2172 of the second positioning portion 217 is disposed on the positioning surface 2172 and along
  • the spreading portion 211 is circumferentially provided with at least one ring of connected or spaced ring electrodes.
  • 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 ring electrode is sutured or glued to the support frame 21a by sutures.
  • the ablation member 23 and the support frame 21a are insulated from each other. Specifically, an insulating film 27 is provided between the outer wall surface of the spreading portion 211 and the corresponding first electrode 231f, and the outer wall surface of the first positioning portion 213a is An insulating film 27 is also provided between the first electrodes 231f, and an insulating film 27 is also provided between the outer wall surface of the second positioning portion 217 and the second electrode 233b.
  • 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 ablation member 23 and the support skeleton 21a can be isolated, not only can the heat conduction between the ablation member 23 and the support skeleton 21a be isolated, and energy can be prevented from being transferred to the support skeleton 21a, thereby concentrating energy on the ablation member 23,
  • 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 the blood reduces the heating of the blood by the current and reduces the risk of thrombosis; the current only flows through the tissue of the interatrial septum between the first electrode 231f and the second electrode 233b, which can prevent the current from affecting other tissues of the body
  • the polarity selection of the two first electrodes 231f and the second electrode 233b on the support frame 21a includes but is not limited to the following four schemes:
  • the two first electrodes 231f are electrically connected to the RF output port through the wire 521, and the second electrode 233b is connected to the RF power supply circuit end through the wire 521.
  • the second electrode 233b is electrically connected to the RF output port through the wire 521, and the two first electrodes 231f are connected to the RF power supply circuit end through the wire 521.
  • One of the first electrodes 231f and the second electrode 233b is connected to the RF output port through the wire 521, and the other first electrode 231f is connected to the RF power supply circuit end through the wire 521.
  • the two first electrodes 231f and the second electrode 233b are respectively connected to the three-phase voltage source A-phase, B-phase, and C-phase output ports, and the three ports output three channels of equal amplitude, the same frequency, and the phase angle are sequentially different by 120 ° With sinusoidal alternating current, the neutral electrode plate is connected to the RF power supply loop end.
  • the interatrial septal ostomy system in this embodiment needs to be used in conjunction with a loader, a sheath tube, a sheath core, a conductive pusher, an RF power output end and a power connection line, and a neutral electrode plate.
  • the specific use flow and method are the same as those in the sixth embodiment, and will not be repeated here.

Abstract

L'invention concerne un système de septostomie auriculaire (100) à méthode d'ablation améliorée, comprenant un dispositif de septostomie auriculaire (20), un mécanisme (50) de commande de dispositif de stomie permettant de commander le dispositif de septostomie auriculaire, et une source d'énergie radiofréquence. Le dispositif de septostomie auriculaire (20) comprend un cadre de support (21, 21a, 21b, 21c) permettant de dilater un trou dans le septum auriculaire. Le dispositif de septostomie auriculaire (20) comprend en outre un élément d'ablation (23) disposé sur le cadre de support (21, 21a, 21b, 21c). La source d'énergie radiofréquence est connectée électriquement au dispositif de septostomie auriculaire (20) par l'intermédiaire du mécanisme (50) de commande de dispositif de stomie. L'élément d'ablation (23) comprend une première électrode (231, 231a, 231b, 231c, 231d, 231f) et une seconde électrode (233, 233a, 233b). L'une parmi la première électrode (231, 231a, 231b, 231c, 231d, 231f) et la seconde électrode (233, 233a, 233b) est connectée électriquement à une extrémité de sortie de la source d'énergie radiofréquence, et l'autre électrode est connectée à une extrémité en boucle de la source d'énergie radiofréquence afin de former une boucle de courant pour recevoir l'énergie en provenance de la source d'énergie radiofréquence pour ablater le septum auriculaire. La présente invention concerne en outre un dispositif de septostomie auriculaire (20) destiné à être utilisé dans le système de septostomie auriculaire (100).
PCT/CN2019/116191 2018-11-09 2019-11-07 Dispositif de septostomie auriculaire à méthode d'ablation améliorée et système de septostomie auriculaire WO2020094087A1 (fr)

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CN201821851963.2U CN209611297U (zh) 2018-11-09 2018-11-09 改进消融方式的房间隔造口装置及房间隔造口系统
CN201811336798.1 2018-11-09
CN201821851963.2 2018-11-09
CN201811336798.1A CN111166463A (zh) 2018-11-09 2018-11-09 改进消融方式的房间隔造口装置及房间隔造口系统

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