WO2020094087A1 - 改进消融方式的房间隔造口装置及房间隔造口*** - Google Patents

改进消融方式的房间隔造口装置及房间隔造口*** Download PDF

Info

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
Authority
WO
WIPO (PCT)
Prior art keywords
electrode
positioning
interatrial
support frame
power supply
Prior art date
Application number
PCT/CN2019/116191
Other languages
English (en)
French (fr)
Inventor
王永胜
王坤
董元博
Original Assignee
杭州诺生医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN201811336798.1A external-priority patent/CN111166463A/zh
Priority claimed from CN201821851963.2U external-priority patent/CN209611297U/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/zh

Links

Images

Classifications

    • 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.

Landscapes

  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Otolaryngology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Plasma & Fusion (AREA)
  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

一种改进消融方式的房间隔造口***(100)，包括房间隔造口装置(20)、控制房间隔造口装置的造口装置控制机构(50)及射频电源，房间隔造口装置(20)包括用于撑开房间隔上的穿孔的支撑骨架(21,21a,21b,21c)，房间隔造口装置(20)还包括设置于支撑骨架(21,21a,21b,21c)上的消融件(23)，射频电源通过造口装置控制机构(50)与房间隔造口装置(20)电连接，消融件(23)包括第一电极 (231,231a,231b,231c,231d,231f) 及第二电极(233,233a,233b)，第一电极(231,231a,231b,231c,231d,231f)与第二电极(233,233a,233b)中的其中一电极电性连接于射频电源输出端，另一电极连接射频电源回路端，以形成电流回路接收射频电源的能量对房间隔进行消融。还涉及一种房间隔造口***(100)的房间隔造口装置(20)。

Description

改进消融方式的房间隔造口装置及房间隔造口*** 技术领域
本申请涉及介入医疗器械技术领域，尤其涉及一种经皮介入的改进消融方式的房间隔造口装置，以及设置有所述房间隔造口装置的房间隔造口***。
背景技术
心力衰竭(简称心衰)，是由于任何心脏结构或功能异常导致心室充盈或射血能力受损的一组复杂临床综合征，其主要临床表现为呼吸困难和乏力(活动耐量受限)，以及液体潴留(肺淤血和外周水肿)。心衰为各种心脏疾病的严重和终末阶段，发病率高，是当今最重要的心血管病之一。根据心力衰竭发生的部位可分为左心、右心和全心衰竭。
心衰是一种发生率和致死率高的严重疾病。我国心衰发病率为2-3％，心衰患病人数在1200万以上。心衰的病因主要有高血压，冠心病，心肌梗死，心脏瓣膜疾病，房颤，心肌病等。心血管疾病造成左心室损伤，导致左心室病理性重构，造成心功能减退。每次成功治疗一位心肌梗死的病人，就带来一位潜在的心衰病人。
在治疗上，优化药物治疗后，患者症状仍反复发作，且目前药物治疗几乎只对射血分数降低的患者有较好的疗效，对射血分数保留的患者疗效并不理想。心脏再同步化治疗并非适合所有的心衰患者，超过20％的患者对于心脏再同步起搏无效。左心室辅助装置手术需体外循环创伤大并发症发生率高，价格昂贵难以获得。心脏移植是最终的解决方案，但是供体的来源非常有限，且价格昂贵。
另一方面，肺动脉高压是以肺动脉***循环阻力进行性增加为特征的一组疾病，其病理变化包括肺血管收缩与重构、肺血管平滑肌和内皮细胞的异常增殖、原位血栓形成等，最终导致右心功能衰竭而死亡。目前，随着对肺动脉高压发病机制的研究越来越深入，其治疗方法也越来越多。肺动脉高压的治疗方案应是具备个体化及***化特征的，绝非单一药物可以治疗的，其治疗方式包括：一般治疗、非特异性药物治疗、靶向药物治疗、NO吸入治疗、基因治疗、介入与手术治疗。肺动脉高压患者疾病后期，经上述综合治疗后效果往往不明显、存活率低、预后极差，这时可试行房间隔造瘘术、肺移植、心肺联合移植等外科治疗方法，从而挽救患者生命，但该类治疗方法存在手术风险大、供体缺乏、移植排斥反应、后续治疗费用高等诸多因素。
房间隔造口术是在患者房间隔处造口，从而形成左右心房间的分流，可用于治疗肺动脉高压(右向左分流)或左心衰(左向右分流)，并在临床上证明了有效性。
传统的房间隔造口方法，如球囊房隔造口术，在造口后有心肌组织有回弹的趋势，并在一段时间以后造口会缩小甚至完全闭合。为了解决造口缩小甚至闭合的问题，现有技术中提供了一种造口支架，可分别公布了一种用于心房分流的植入物，其特点是在经皮房间隔穿刺术后，经皮输送一植入物在房间隔穿刺处植入分流器械，以保持分流开口处通畅。
另外一种造口器械，包括切割装置及抓取装置，器械在对组织进行造口时，抓取装置先对所需要切割的部分组织进行定位并抓取；然后由切割装置的切割部对抓取装置所抓取的部分组织进行切割，切割下来的部分组织被抓取装置带出体外，从而形成造口。
上述技术存在如下缺陷：用于心房分流的植入物，在造口处留下了器械，容易导致血栓形成，或器械脱落，形成栓塞。此外，由于内皮爬覆可导致器械开口被封堵，通道关闭失去分流作用。另外，在手术过程中通过机械或高频电刀对心内组织进行切割，有较高的风险，如在术中抓取装置手术中发生松动或在回收时，可能导致所切割的组织脱落并形成栓塞。此外，如果在切割过程中，抓取装置的松动极易导致其它心肌组织受损。
申请内容
本申请的目的在于提供一种造口不易封堵的、改进消融方式的房间隔造口装置，以及设置有所述房间隔造口装置的房间隔造口***。
为了解决上述技术问题，本申请提供了一种改进消融方式的房间隔造口装置，其包括用于扩张房间隔上的穿孔的支撑骨架，所述房间隔造口装置还包括设置于所述支撑骨架上的消融件，所述消融件包括第一电极及第二电极，所述第一电极与第二电极中的其中一电极电性连接于射频电源，另一电极连接射频电源回路端，以形成电流回路接收射频电源的能量对房间隔进行消融。
本申请还提供一种房间隔造口***，其包括房间隔造口装置、控制所述房间隔造口装置的造口装 置控制机构及射频电源，所述房间隔造口装置包括用于扩张房间隔上的穿孔的支撑骨架，所述房间隔造口装置还包括设置于所述支撑骨架上的消融件，所述射频电源通过造口装置控制机构与房间隔造口装置电连接，所述消融件包括第一电极及第二电极，所述第一电极与第二电极中的其中一电极电性连接于射频电源输出端，另一电极连接射频电源回路端，以形成电流回路接收射频电源的能量对房间隔进行消融。
本申请的房间隔造口***包括扩张房间隔上的穿孔的支撑骨架，以及设置于所述支撑骨架上的消融件，其中一电极电性连接于射频电源输出端，另一电极连接射频电源回路端，从而使所述第一电极与所述第二电极形成电流回路以接收所述射频电源的能量对房间隔进行消融，使穿孔附近的房间隔组织失去活性，防止因组织的修复内皮爬覆将所述穿孔堵塞，且经房间隔造口***造口后，能够固定造口后穿孔的形态，造口不易封堵，能保持造口的通畅；另外，第一电极与第二电极均设置于支撑骨架上，容易控制消融件的电流的分布，使电流能够集中在房间隔于第一电极与第二电极之间释放，即能量容易聚集并能造成持续性损伤，防止电极上的射频能量流失，提高消融效率，且防止身体的其他组织的损伤。
附图说明
为了更清楚地说明本申请实施例中的技术方案，下面将对实施例中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的明显变形方式。
图1是本申请第一实施例提供的房间隔造口***的结构示意图；
图2是图1中的房间隔造口***的房间隔造口装置的放大图；
图3是图2中的房间隔造口装置的导线组件的展开示意图；
图4是图3中的导线组件的其中一导线的剖视结构示意图；
图5是图1中V部分的放大示意图。
图6是图5中沿VI-VI线的剖视图；
图7是图5中沿VII-VII线的剖视图；
图8至图11是本申请第一实施例提供的房间隔造口***的使用操作过程示意图。
图12是本申请第二实施例提供的房间隔造口***的消融封堵装置的结构示意图；
图13是本申请第三实施例提供的房间隔造口***的消融封堵装置的结构示意图；
图14是本申请第四实施例提供的房间隔造口***的消融封堵装置的结构示意图；
图15是本申请第五实施例提供的房间隔造口***的消融封堵装置的结构示意图；
图16是本申请第六实施例提供的房间隔造口***的消融封堵装置的结构示意图；
图17是本申请第七实施例提供的房间隔造口***的消融封堵装置的结构示意图；
图18是本申请第八实施例提供的房间隔造口***的结构示意图；
图19是图18中的房间隔造口***的消融封堵装置增加绝缘膜的结构示意图；
图20是本申请第九实施例提供的房间隔造口***的结构示意图；
图21是本申请第十实施例提供的房间隔造口***的结构示意图；
图22是本申请第十一实施例提供的房间隔造口***的结构示意图；
图23是图22中的房间隔造口***的消融封堵装置增加绝缘膜的结构示意图；
图24是图23中沿XXIV-XXIV线的剖视图；
图25是图24中XXV部分的放大图；
图26是本申请第十二实施例提供的房间隔造口***的结构示意图；
图27是图26中的房间隔造口***的消融封堵装置增加绝缘膜的结构示意图；
图28是本申请第十三实施例提供的房间隔造口***的结构示意图。
具体实施方式
下面将结合本申请实施例中的附图，对本申请实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本申请一部分实施例，而不是全部的实施例。基于本申请中的实施例，本领域普通技术人员在没有付出创造性劳动前提下所获得的所有其它实施例，都属于本申请保护的范围。
此外，以下各实施例的说明是参考附加的图示，用以例示本申请可用以实施的特定实施例。本申 请中所提到的方向用语，例如，“上”、“下”、“前”、“后”、“左”、“右”、“内”、“外”、“侧面”等，仅是参考附加图式的方向，因此，使用的方向用语是为了更好、更清楚地说明及理解本申请，而不是指示或暗指所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本申请的限制。
为了更加清楚地描述止血阀、鞘管及导管鞘组件的结构，本申请所述的限定术语“近端”及“远端”为介入医疗领域惯用术语。具体而言，“远端”表示手术操作过程中远离操作人员的一端，“近端”表示手术操作过程中靠近操作人员的一端。除非另有定义，本申请所使用的所有的技术和科学术语与属于本申请的技术领域的技术人员通常理解的含义相同。本申请在说明书中所使用的惯用术语只是为了描述具体实施例的目的，并不能理解为对本申请的限制。
请参阅图1及图2，图1是本申请第一实施例提供的改进消融方式的房间隔造口***的第一种实施方式的结构示意图；图2是图1中的房间隔造口***的房间隔造口装置的放大图。本申请提供一种房间隔造口***100，其包括一房间隔造口装置20及用于控制所述房间隔造口装置20的造口装置控制机构50。所述房间隔造口装置20包括用于扩张房间隔上的穿孔的一支撑骨架21，所述支撑骨架21用于扩张所述穿孔以形成造口。所述支撑骨架21上设置有消融件23，所述消融件23包括第一电极231及第二电极233，所述第一电极231及第二电极233均与房间隔接触，所述第一电极231和第二电极233的其中一电极电性连接于射频电源输出端，另一电极连接射频电源回路端，即当第一电极231电性连接于射频电源输出端，第二电极233连接射频电源回路端；或者当第二电极233电性连接于射频电源输出端时，第一电极231连接射频电源回路端。所述第一电极231与所述第二电极233形成电流回路以接收所述射频电源输出端的能量对房间隔进行消融。
本实施例中，所述第一电极231作为消融用的电极，所述第二电极作233为连接射频电源回路端电极。
本申请的房间隔造口***100的房间隔造口装置20包括扩张房间隔上的穿孔的支撑骨架21，以及设置于所述支撑骨架21上的消融件23，所述第一电极231及第二电极233均接触所述穿孔附近的房间隔组织，其中一电极电性连接于射频电源输出端，另一电极连接射频电源回路端，所述第一电极231与所述第二电极233形成电流回路以接收所述射频电源的能量对房间隔进行消融，从而使穿孔附近的房间隔组织失去活性，防止因组织的修复内皮爬覆将所述穿孔堵塞，且经房间隔造口***100造口后，能够固定造口后穿孔的形态。因此，经所述房间隔造口装置20处理后的造口形状较为规则，且不易封堵，能保持造口的通畅，进而使左右心房间的血液分流顺畅；另外，由于所述第一电极231与所述第二电极233均位于所述支撑骨架21上，因此，第一电极231与第二电极233之间的距离较短，容易控制消融件23的电流的分布，使电流能够集中在房间隔组织于第一电极231与第二电极233之间释放，即能量容易聚集并能造成持续性损伤，防止电极上的射频能量流失，提高消融效率，且防止身体的其他组织的损伤。
如图2所示，所述支撑骨架21为自膨胀式造口装置，所述支撑骨架21可以是超弹性或记忆合金金属支撑骨架或弹性的非金属支撑骨架。本实施例中，所述支撑骨架21为镍合金支架，当房间隔造口装置20通过鞘管输送时，所述支撑骨架21的直径可收缩至较小状态以便在鞘管中输送；当所述房间隔造口装置20在心脏房间隔附近位置释放时，支撑骨架21可自动膨胀至所需形状尺寸，以使所述支撑骨架21能扩张房间隔上的穿孔以形成造口，即所述支撑骨架21在所述穿孔内的部分对穿孔的内壁产生径向的支撑作用。
支撑骨架21可以采用镍合金管切割而成，也可以采用镍合金丝编织而成。支撑骨架21的网状结构的疏密程度根据需要设定。本实施例中采用菱形或类菱形结构单元连续周向排布一圈形成，支撑骨架21整体形状可以是直筒形、盘状、锥形等多种适用形状，在此不作限定。
所述支撑骨架21的外壁面及内壁面上均涂设有绝缘涂层，所述绝缘涂层可以是但不限定于聚四氟乙烯涂层、聚氨酯涂层或聚酰亚胺涂层等。本实施例中，所述支撑骨架21的外壁面及内壁面上均涂设有聚四氟乙烯涂层。
在其他实施例中，所述支撑骨架21的镍合金丝上也可以套设有绝缘套管。
在所述房间隔造口装置20完全释放的状态下，支撑骨架21包括圆柱形的一撑开部211、设置于所述撑开部211一端的一第一定位部213、设置于所述撑开部211背朝所述第一定位部213一端的一延伸部214，以及设置于所述延伸部214远离所述撑开部211一端的一回收部215。所述撑开部211用于扩张所述房间隔上的穿孔以形成造口；所述第一定位部213用于定位所述支撑骨架21至所述房间隔的穿孔内；所述延伸部214能够避免撑开部211向远端延伸时偏离所述房间隔的穿孔，而导致无法扩张该处组织，因此，所述延伸部214能够补偿撑开部211偏离所述穿孔处而带来的不良影响。
本实施例中，当所述支撑骨架21完全释放于房间隔的穿孔内时，所述撑开部211释放后能径向膨胀，从而能均匀扩张房间隔上穿孔，以扩大房间隔上的穿孔形成造孔。具体的，撑开部211为连续周向 排布一圈波形环状结构，所述第一定位部213的近端与所述撑开部211相连接，即第一定位部213与波形环状结构的波峰相连接，所述第一定位部213的远端径向辐射延伸以形成锥形或圆形的定位面2132。所述第一定位部213包括还包括外缘翻翘结构，所述外缘翻翘结构为自第一定位部213的外缘部分向远离撑开部211的一侧圆滑过渡弯曲，避免损伤心房组织。延伸部214的近端与所述撑开部211相连，即所述延伸部214与所述波形状结构的波谷相连接，所述延伸部214的远端轴向延伸；回收部215的近端与所述延伸部214相连接，所述回收部215的远端轴向延伸并汇合。
在其他实施例中，支撑骨架21可以是网状支架、杆状支架、多层的波形支架或它们组合形成的管状结构或环状结构。网状支架具有明显的经纬交错结构，或具有重复的单元格结构，既可以采用编织也可以是切割方式，经纬交错部位既可以相对滑动也可以相互固定；波形支架具有多圈环状的波形结构，包括波峰、波谷和波杆，周向相邻的波杆在近端相连接形成波峰，远端相连接形成波谷；管状结构可理解为轴向上延伸一段距离，例如轴向尺寸大于等于管状结构的外径，相对于管状结构，环状结构的轴向尺寸略小，一般小于环状结构的外径；轴向相邻的两圈波形结构可通过覆膜连接，或者多圈覆膜固定连接于管状覆膜上；杆状支架具有多根轴向延伸的支撑杆，支撑杆合围形成管状结构，支撑杆之间可通过高分子聚合物的覆膜连接，或者支撑杆固定连接于管状覆膜上。
撑开部211的形状可以有多种，例如撑开部211可以为外侧壁内凹或/和外凸的曲面形、圆筒形、椭圆筒形或者是它们的组合。曲面形是在周向形成一个封闭的曲面结构，外凸和内凹的位置可以根据需要设定，可以单独形成外凸结构或内凹结构，也可以将外凸或内凹结构相结合设置在同一个撑开部211上。外凸结构如：盘状、球台形等，内凹结构如：腰鼓形，本实施例中采用圆筒形结构，与支撑骨架21的直筒形平滑过渡形成一个整体圆筒结构。撑开部211的轴向长度根据实际需要设定，一般与房间隔的厚度匹配即可。
回收部215呈圆锥状，其包括设置于近端的若干延伸片2151，以及位于远端的连接件2152，若干所述延伸片2151连接于延伸部214与连接件2152之间，连接件2152用于连接造口装置控制机构50。所述连接件2152为管状结构，所述管状结构的释放状态的外径小于延伸部214的释放状态的外径。所述连接件2152上沿周向开设有若干固定孔2154，固定孔2154用于将连接件2152固定于造口装置控制机构50上。
本实施例中，消融件23的第一电极231设置在撑开部211上，第二电极233设置于第一定位部213上。具体的，所述第一电极231设置于撑开部211的外壁面上，第二电极233设置于第一定位部213的定位面2132上，撑开部211的外壁面及第一定位部213的定位面2132均接触所述房间隔表面。因此，第一电极231及第二电极233均接触所述房间隔，第一电极231与第二电极233之间形成电流回路，即电流仅流过第一电极233与第二电极233之间的房间隔的组织，以防止电流对人体的其他组织的损坏，且能够将射频能量集中用于消融的第一电极233，达到更好的消融效果。
请一并参阅图2至图4，本实施例中，所述消融件23包括若干第一柔性导线235及若干第二柔性导线236，第一柔性导线235的结构与第二柔性导线236相同，仅长度不同。第一柔性导线235与第二柔性导线236间隔并排设置。每一第一柔性导线235的近端设置有消融部，所述消融部即为第一电极231，第一柔性导线235的远端设置有连接部237。每一第一柔性导线235通过胶粘或缝线缝合至所述支撑骨架21的外壁面上。每一第一柔性导线235的第一电极231位于所述撑开部211的外壁面上，具体的，这些第一电极231沿所述撑开部211的周向设置至少一圈；每一第一柔性导线235的连接部237轴向延伸出所述连接件2152并电性连接于射频源。每一第二柔性导线236的近端设置有消融部，所述消融部即为第二电极233，第二柔性导线236的远端设置有连接部237，每一第二柔性导线236的第二电极233位于所述第一定位部213的定位面2132上，具体的，这些第二电极233沿所述撑开部211的周向设置至少一圈。每一第二柔性导线236的连接部237轴向延伸出所述连接件2152并连接射频电源回路端。
如图4所示，本实施例中，第一柔性导线235及第二柔性导线236均包括柔性的金属层2351、套设于所述金属层2351外的绝缘层2353，以及胶贴于所述绝缘层2353外用于粘贴至支撑骨架21上的胶粘层2355。第一电极231及第二电极233是分别在第一柔性导线235及第二柔性导线236的近端去除背朝所述胶粘层2355的一侧的绝缘层2353而形成；连接部237是分别在第一柔性导线235及第二柔性导线236的远端去除绝缘层2353及胶粘层2355而形成。
如图1、图5及图6，造口装置控制机构50包括推送件52、一外鞘管组件54、及一控制手柄56。所述推送件52与房间隔造口装置20可拆卸连接或者一体固定连接，所述推送件52内设置有导线521，导线521与房间隔造口装置20的第一柔性导线235及第二柔性导线236电连接。
推送件52包括一双腔管520及套设于所述双腔管520近端外壁上的一连接套523。具体的，所述双腔管520的近端外壁面上周向开设有收容口5202，所述连接套523套接于所述双腔管520上并收容于 所述收容口5202内，此时，所述连接套523的外表面与所述双腔管520的外表面对齐。所述双腔管520由聚乙烯制成，所述双腔管520包括轴向延伸的第一腔体5201及第二腔体2503。所述第一腔体5201用于放置鞘芯，所述第二腔体2503用于收容导线521。推送件52的近端与所述房间隔造口装置20的远端的连接件2152通过机构连接。具体的，所述连接套523是由导电金属制成的管体，所述连接套523的近端套接于所述连接件2152的远端，所述推送件52内的其中一导线521的近端穿过双腔管520的管壁后焊接于所述连接套523上，所述导线521的远端沿第二腔体2503延伸直至连接于射频电源输出端。消融件23的第一柔性导线235的连接部237焊接于连接套523的外壁面上；第二柔性导线236的连接部237直接电性连接于所述推送件52内的另一导线521，所述另一导线521连接射频电源回路端。此时，第一电极231作为消融电极，第二电极233作为连接射频电源回路端电极。
所述连接套523及所述连接件2152外还套设有保护管527，所述保护管527由聚四氟乙烯、聚氨酯或聚酰亚胺等绝缘材料制成，所述保护管527的近端套设于所述连接套523及连接件2152的外壁面上，保护管527的远端从推送件52近端向后延伸，直到覆盖过连接套523后面一段长度。此时，所述消融件23的每一第一柔性导线235及第二柔性导线236的的连接部237位于所述连接套523与所述保护管527之间，所述第一柔性导线235与第二柔性导线236之间绝缘处理。所述连接套523处的所有材料也熔合在一起，焊接处完全熔于材料内部，从而保证电性连接的安全可靠。
如图1所示，外鞘管组件54包括具有鞘管腔541的鞘管540，及鞘芯543。所述推送件52位于鞘管腔541内，鞘芯543位于所述推送件52的第一腔体5201内。鞘芯543包括由具有空腔的PEEK管5432，及设置于所述PEEK管5432的前端并与所述鞘管540相匹配的顶头5434。所述PEEK管5432收容于所述推送件52的第一腔体5201内，所述顶头5434在所述房间隔造口装置20***房间隔的穿孔时具有引导的作用。
推送件52、鞘管540、鞘芯543的后端分别与控制手柄56连接。控制手柄56的远端设置有与射频电源连接的接头562。推送件52的导线521远端与接头562电性连接，从而使第一电极231连接消融电源，第二电极连接射频电源回路端。控制手柄56设置有相互独立的运动机构，可以实现推送件52、鞘管540、鞘芯543相互独立的运动。
请一并参阅图1、图2及图8至图11，本实施例中，房间隔造口装置20、推送件52、鞘芯543、鞘管540和控制手柄56为一套完整的***，本实施例的房间隔造口***操作流程如下所示：
采用穿刺机构对房间隔601穿刺，穿刺后，将导丝送入到左上肺静脉605内并撤出穿刺套件；
连接手柄近端的接头562到射频电源，并沿导丝将预装在鞘管540内的房间隔造口装置20推送至体内并使鞘管前端位于左心房606内；
后撤鞘管540使房间隔造口装置20的第一定位部213完全出鞘，第一定位部213完全张开，通过超声或DSC判断第一定位部213是否完全张开。过程中需保证鞘管540远端一直位于左心房内。然后保持器械间无相对运动并向后拉动鞘管540使第一定位部213紧贴在房间隔601面朝所述左心房的表面上，观察并使第二电极233与房间隔601的组织接触良；
后撤鞘管540使房间隔造口装置20的撑开部211完全出鞘，通过超声或DSC判断，并将房间隔601撑开一小孔，即在所述房间隔601上形成造口603；
观察并使消融件23与房间隔601的组织接触良好，然后设置加热参数(如功率30W，持续时间120S)，然后启动加热。
加热停止后，向前推送鞘管540，使回收部215及延伸部214收缩至较小尺寸并收入鞘管540中，再向前推送鞘管540使撑开部211及第一定位部213均完全回收至鞘管，并整体后撤。然后通过超声或DSC测量造口603大小是否达到临床需求。
本实施例中的房间隔造口***100的撑开部211将房间隔上的穿孔撑开而形成造口，所述支撑骨架21上的消融件23能将所述房间隔于穿孔附近的组织进行消隔，从而能防止穿孔附近的内皮爬覆封堵所述造口，能保持造口的通畅；其次，由于所述第一电极231与所述第二电极233均位于所述支撑骨架21上，因此，第一电极231与第二电极233之间的距离较短，容易控制消融件23的电流的分布，即电流仅经过第一电极231与第二电极233之间的房间隔组织，使射频能量能够集中在房间隔于第一电极231与第二电极233之间释放，即能量容易聚集并能造成持续性损伤，防止电极上的射频能量流失，提高消融效率，且防止身体的其他组织的损伤；另外，房间隔造口装置20在完成造口后能进行回收，即所述房间隔造口装置20无需保留在房间隔上，从而避免了器械脱落形成栓塞。
在其实施例中，第一电极231可以设置于第一定位部213的定位面2132面上，第二电极233可以设置于撑开部211的外壁面上；第一电极231及第二电极233均可相互间隔地设置于第一定位部213的定位面2132或撑开部211的外壁面上；第二电极233还可以设置于延伸部214的外壁面上，第一电极 231还可以设置于第一定位部213的定位面2132及撑开部211的外壁面。
在其他实施例中，所述第一定位部213的远端径向辐射延伸以形成若干定位杆，若干所述定位杆围成锥形或圆形。第一电极231和/或第二电极233设置于定位杆上，使第一电极231和/或第二电极233接触房间隔。
在其他实施例中，所述第一定位部213的远端径向辐射延伸以形成若干定位杆，若干所述定位杆围成锥形或圆形，这些定位杆上设置有若干定位点。第一电极231和/或第二电极233设置于若干所述定位点上，使第一电极231和/或第二电极233接触房间隔。
在其他实施例中，所述第一定位部213的远端径向辐射延伸以形成定位面，所述定位面上设置有若干定位点，第一电极231和/或第二电极233设置于定位点上，使第一电极231和/或第二电极233接触房间隔。
请一并参阅图12，图12是本申请第二实施例提供的房间隔造口***的消融封堵装置的结构示意图。本申请第二实施例提供的消融封堵装置的结构与第一实施例的结构相似，不同之处在于：在第二实施例中，支撑骨架21是金属支撑骨架，具体的，支撑骨架21是镍合金支撑骨架，支撑骨架21作为消融件23的连接射频电源回路端端。具体的，所述第一定位部213的定位面2132上设置有电性裸露区域，支撑骨架21的外表面除所述电性裸露区域外均涂设有绝缘涂层，所述电性裸露区域作为消融件23的第二电极233。所述电性裸露区域可以设置于定位面2132上的至少一处。支撑骨架21的连接件2152通过导线穿过推送件52连接射频电源回路端，从而使电性裸露区连接射频电源回路端，即第二电极233连接射频电源回路端。
每一导线235的近端均设置有第一电极231，第一电极231胶粘于撑开部211的外壁面上，这些第一电极231沿撑开部211的外壁面周向设置连接的或间断的至少一圈。每一导线235的远端电性连接于连接套，再通过推送件52的导线521及接头562电性连接于射频电源。第一电极231作为消融电极，第二电极233作为连接射频电源回路端电极。
使用消融封堵装置时，撑开部211支撑于房间隔的穿孔内，使第一电极231接触房间隔；第一定位部213位于左心房内且定位面2132接触房间隔表面，使第二电极233接触房间隔；所述第一电极231与所述第二电极233形成电流回路，电流仅流过第一电极233与第二电极233之间的房间隔的组织，第一电极231接收所述射频电源输出端的能量对房间隔进行消融，使穿孔附近的房间隔组织失去活性，防止因组织的修复内皮爬覆将所述穿孔堵塞。
在其他实施例中，第一定位部213的定位面2132上的电性裸露区域是沿撑开部211的周向设置连接的或间断的至少一圈，支撑骨架21通过推送件52内的导线521电性连接于射频电源输出端，即第二电极233电性连接于射频电源输出端；第一电极231可以通过推送件52内的导线连接射频电源回路端，即电性裸露区域作为消融电极对房间隔进行。此时，第二电极233为消融电极，第一电极231作为连接射频电源回路端电极。
在其他实施例中，撑开部211的外壁面上沿其周向设置连接的或间断的至少一圈的电性裸露区域，所述电性裸露区域通过支撑骨架21及推送件52内的导线连接射频电源回路端或电性连接射频电源输出端，即，所述电性裸露区域既可以当作消融电极，也可以当作连接射频电源回路端电极。
本实施例中的房间隔造口***在使用时，需与装载器、鞘管、鞘芯、可导电的推送器、射频电源输出端及电源联接线等联合使用。具体的使用流程及方法与第一实施例相同，在此不再赘述。
请参阅图13，图13是本申请第三实施例提供的房间隔造口***的消融封堵装置的结构示意图。本申请第三实施例提供的消融封堵装置的结构与第一实施例的结构相似，不同之处在于：在第三实施例中，支撑骨架21与消融件23之间设置有绝缘膜27。进一步的，绝缘膜27位于消融件23的第一电极231与支撑骨架21之间。所述绝缘膜27可以是但不限于聚四氟乙烯薄膜、聚氨酯薄膜、或聚酰亚胺薄膜等。所述第一电极231是消融电极，第二电极233为连接射频电源回路端电极，第一电极231用于对房间隔组织进行消融。由于所述支撑骨架21与所述第一电极231之间通过绝缘膜27进行隔离，因此，所述绝缘膜27不仅能隔绝消融电极与支撑骨架21之间的热量传导，即防止能量传递至支撑骨架21上，从而能将热量集中在第一电极231上以对房间隔组织进行消融，提高能量利用率；并且所述绝缘膜27还可以在第一电极231面向血液的一侧形成绝缘屏障，从而减小通过血液的电流密度，减小消融件23对血液的加热，降低血栓形成的风险。
本实施例中，所述绝缘膜27设置于所述支撑骨架21对应所述消融件23的外壁面上。具体的，所述绝缘膜27通过缝线缝合或胶粘的方式连接于所述支撑骨架21的外壁面上。
在其他实施例中，所述绝缘膜27也可以设置于所述消融件23对应所述支撑骨架21的表面，具体的，所述绝缘膜27通过胶粘的方式贴合于所述消融件23面朝所述支撑骨架21的外表面上。
消融件23投影至绝缘膜27上的区域位于绝缘膜27内，即消融件23在绝缘膜27上的投影面积小于或等于绝缘膜27的面积，从而使隔离所述第一电极231与支撑骨架21之间的热量传导。
本实施例中的房间隔造口***在使用时，需与装载器、鞘管、鞘芯、可导电的推送器、射频电源及电源联接线等联合使用。具体的使用流程及方法与第一实施例相同，在此不再赘述。
请参阅图14，图14是本申请第四实施例提供的房间隔造口***的消融封堵装置的结构示意图。本申请第四实施例提供的消融封堵装置的结构与第三实施例的结构相似，不同之处在于：在第四实施例中消融件的结构与第三实施不同，在第四实施例中，消融封堵装置20的消融件23的第一电极231a包括若干间隔的点状电极，这些点状电极沿支撑骨架21的外壁表面的周向设置至少一圈。具体的，这些点状电极沿撑开部211的外壁表面周向设置一圈，第一电极231a与支撑骨架21之间绝缘处理。所述绝缘处理的方式为在与点状电极接触的支撑骨架21的外壁面涂覆绝缘涂层，或者在所述支撑骨架21与点状电极接触的金属丝上穿插绝缘套管，绝缘套管包裹在所述支撑骨架12的金属丝的外壁面，并且在消融件23与支撑骨架21之间设置有绝缘膜27。所述绝缘涂层或套管材料可选自FEP/ETFE/PFA，所述绝缘膜27可以是但不限于聚四氟乙烯薄膜、聚氨酯薄膜、或聚酰亚胺薄膜等。
本实施例中，这些点状电极是作为消融的电极，这些点状电极通过一根导线串联后电性连接于柔性导线235，所述柔性导线235通过所述连接件2152、连接套523、及推送件内的导线电性连接于射频电源。
本实施例中的房间隔造口***在使用时，需与装载器、鞘管、鞘芯、可导电的推送器、射频电源及电源联接线等联合使用。具体的使用流程及方法与第三实施例相同，在此不再赘述。
本实施例中的房间隔造口装置20的撑开部211将房间隔上的穿孔扩张而形成造口，所述撑开部211上的消融件23的第一电极231a能将所述穿孔内壁的组织进行消隔，从而能防止穿孔附近的内皮爬覆封堵所述穿孔，防止穿孔封堵，能保持穿孔的通畅；其次，所述绝缘膜27还可以在消融件23的第一电极231a面朝血液的一侧形成绝缘屏障，从而减小通过血液的电流密度，减小第一电极231a对血液的加热，降低血栓形在的风险另外；另外，房间隔造口装置20在完成造口后能进行回收，即所述房间隔造口装置20无需保留在房间隔上，从而避免了器械脱落形成栓塞；还有，消融件23的电流仅流经第一电极231a与第二电极233之间的房间隔，防止电极上的射频能量流失，提高消融效率，且防止身体的其他组织的损伤。
请参阅图15，图15是本申请第五实施例提供的房间隔造口***的消融封堵装置的结构示意图。本申请第五实施例提供的消融封堵装置的结构与第三实施例的结构相似，不同之处在于：第五实施例中消融件的结构与第三实施不同，在第五实施例中，消融封堵装置20的消融件23的第一电极231b为设置在支撑骨架21的外壁周向上的单圈间断的环状电极，所述环状电极与支撑骨架21之间绝缘处理。具体的，单圈间断的环状电极设置于撑开部211的外壁面上，所述环状电极与所述撑开部211之间设置有绝缘膜27。环状电极通过一根导线串联后电性连接于导线235，所述导线235通过连接套523及推送件52内的导线521与射频电源输出端连接。
本实施例中的房间隔造口***在使用时，需与装载器、鞘管、鞘芯、可导电的推送器、射频电源及电源联接线、中性电极板等联合使用。具体的使用流程及方法与第一实施例相同，在此不再赘述。
在其他实施例中，消融件23的第一电极231c可以为设置在支撑骨架21的外壁周向上的单圈不间断的环状电极，环状电极通过导线与射频电源输出端连接。
请参阅图16，图16是本申请第六实施例提供的房间隔造口***的消融封堵装置的结构示意图。本申请第六实施例提供的消融封堵装置的结构与第三实施例的结构相似，不同之处在于：在第六实施例中的消融件的结构与第三实施不同，在第六实施例中，消融件23的第一电极231c包括若干间隔的杆状电极，每一杆状电极沿支撑骨架21的轴向延伸，这些杆状电极沿支撑骨架21的外壁面的周向设置至少一圈。具体的，这些杆状电极沿撑开部211的外壁面设置至少一圈，消融件23与支撑骨架21之间绝缘处理。所述绝缘处理的方式为在与杆状电极接触的支撑骨架21的外壁面涂覆绝缘涂层，或者在所述支撑骨架21与杆状电极接触的金属丝上穿插绝缘套管，绝缘套管包裹在所述支撑骨架21的金属丝的外壁面，并且在消融件23与支撑骨架21之间设置有绝缘膜27。所述绝缘涂层或套管材料可选自FEP/ETFE/PFA，所述绝缘膜27可以是聚四氟乙烯薄膜、聚氨酯薄膜、或聚酰亚胺薄膜等。
本实施例中的房间隔造口***在使用时，需与装载器、鞘管、鞘芯、可导电的推送器、射频电源及电源联接线、中性电极板等联合使用。具体的使用流程及方法与第二实施例相同，在此不再赘述。
请参阅图17，图17是本申请第七实施例提供的房间隔造口***的消融封堵装置的结构示意图。本申请第七实施例提供的消融封堵装置的结构与第一实施例的结构相似，不同之处在于：在第七实施例中，支撑骨架21为金属支撑骨架，具体的，支撑骨架21是自膨胀式的镍合金支架，房间隔造口装置20 在完全释放的状态下，房间隔造口装置20也包括圆筒状的撑开部211、第一定位部213、延伸部214及回收部215，其中第一定位部213位于撑开部211的一端，延伸部214位于撑开部211远离所述第一定位部213的一端。
回收部215的近端连接于延伸部214远离撑开部211的一端，回收部215的远端收缩于连接件2152。所述连接件2152为圆筒状，连接件2152内设置有一定位件2155，所述定位件2155通过胶粘、卡接或螺接于所述连接件2152内。本实施例中，定位件2155为金属导电件，具体的，定位件2155为金属螺母，所述连接件2152的内表面设置有内螺纹，所述定位件2155螺接于所述连接件2152内。所述定位件2155的中部轴向开设有螺孔2157，所述螺孔2157用于连接推送件52。所述定位件2155与所述连接件2152通过绝缘处理。
本实施例中的消融件23的第一电极231d为设置于第一定位部213的定位面2132上的环形电极，所述环形电极沿撑开部211的周向围绕一圈，所述环形电极与撑开部211在径向上设置有间隙，具体的，所述环形电极与撑开部211的径向距离可设置为0～5mm，优选设置3mm；第二电极233a为沿撑开部211的外壁面围绕至少一圈的环形电极。第一电极231d通过柔性导线238电性连接于定位件2155。具体的，所述柔性导线238位于所述支撑骨架21内，所述柔性导线238的一端穿过支撑骨架21后焊接于第一电极231d，所述柔性导线238的另一端焊接于定位件2155，所述定位件2155通过推送件52内的导线电性连接于射频电源输出端。第二电极233a通过另一柔性导线238连接射频电源回路端。
本实施例中，第一电极231d及第二电极233a均为一连续环状的、有较高弹性的、柔软的金属线材。如镍钛多股丝、或黄金弹簧包裹的镍钛多股丝等结构。第一电极231d及第二电极233a可通过缝线缝合和(或)捆绑附着在支撑骨架21上。
在其他实施例中，所述定位件2155也可以由不导电材料制成，所述定位件2155轴向地开设有穿线孔，柔性导线238远离消融件23的一端穿过所述穿线孔后直接电性连接于射频电源输出端或连接射频电源回路端。
所述支撑骨架21上于撑开部211的外壁面上周向设置有至少一圈的显影标志2114。具体的，在撑开部211上邻近消融件23处开设有若干通孔2112，这些通孔2112沿所述撑开部211的周向排列一圈。两根柔性导线23的近端分别穿过两个通孔2112后电性连接于第一电极231d及第二电极233a。在其他的通孔2112内设置有显影标志2114，即这些显影标志2114围绕撑开部211一圈，以方便支撑骨架21的植入及定位。显影标志2114通过机械、焊接或粘接的方式设置于对应的通孔2112内。显影标志2114的材料可选择但不限于：金、铂、铂-钨、钯、铂-铱、铑、钽，或这些金属的合金或复合物。
第一定位部213为从连接所述撑开部211的端边的连接点径向辐射出去形成的盘状结构，所述盘状结构的直径大于撑开部211的直径。在本实施例中，所述第一定位部213设置为一圆形单层平面结构，所述圆形单层平面结构面朝撑开部211的侧面为定位面2132。当所述撑开部211穿置于房间隔的造口内时，第一定位部213的定位面2132与房间隔于造口的外周面接触，以避免所述撑开部211偏离房间隔的造口位置。
进一步的，所述第一定位部213包括还包括外缘翻翘结构，所述外缘翻翘结构为自第一定位部213的外缘部分向远离撑开部211的一侧圆滑过渡弯曲，避免损伤心房组织。
支撑骨架21内外表面均涂设有绝缘层，如镀有派瑞林绝缘涂层，从而使第一电极231d及第二电极233a与支撑骨架21相互绝缘。进一步的，在消融件23与支撑骨架21之间设置有绝缘膜27。具体的，绝缘膜27设置为环状结构，绝缘膜27包括覆盖于第一定位部213邻近撑开部211处一周的第一环状绝缘膜，以及覆盖于撑开部211邻近第一定位部213处一周的第二环状绝缘膜。通过使用绝缘膜27能隔绝消融件23和支撑骨架21，不仅可以隔绝消融件23与支撑骨架21之间的热量传导，防止能量传递至支撑骨架21上，从而将能量集中在第一电极231d上，以对房间隔面朝左心房的表面于穿孔附近的组织进行消融，提高能量利用率；并且绝缘膜27能在消融件23面向血液的一侧形成绝缘屏障，减小通过血液的电流密度，减小电流对血液的加热，降低血栓形在的风险；另外，消融件23的电流仅流经第一电极231d与第二电极233a之间的房间隔，防止电极上的射频能量流失，提高消融效率，且防止身体的其他组织的损伤。
在其他实施例中，绝缘膜27也可以仅包括覆盖于第一定位部213邻近撑开部211处一周的第一环状绝缘膜，即绝缘膜27可以省略第二环状绝缘膜。所述第一环状绝缘膜用于隔绝第一电极231d与第一定位部213。
将定位件2155连接于推送件，即推送件的近端可以螺接于定位件2155，具体的，定位件2155通过螺孔2157连接于推送件上。所述推送件内的导线电性连接于定位件2155，从而使第一电极231d通过柔性导线238、定位件2155及推送件内的导线电性连接于射频电源输出端；连接于第二电极233a上的 柔性导线238通过推送件连接射频电源回路端。
本实施例中的房间隔造口***在使用时，需与装载器、鞘管、鞘芯、可导电的推送器、射频电源及电源联接线等联合使用。具体的使用流程及方法与第一实施例相同，在此不再赘述。
在其他实施例中，第一电极231d可以是围绕撑开部211设置于所述撑开部211的外壁面上的至少一圈的环形电极，所述第一电极231d与所述撑开部211的外壁面之间设置有绝缘膜27。
在其他实施例中，第一电极231d可以是围绕撑开部211设置于所述撑开部211的外壁面及所述第一定位部213的定位面2132上的至少一圈的波浪型环形电极，即所述波浪型环形电极的一部分位于所述撑开部211的外壁面上，另一部分位于第一定位部213的定位面2132上，所述第一电极231d与所述撑开部211及第一定位部213的外壁面之间设置有绝缘膜27。
请参阅图18及图19，图18是本申请第八实施例提供的房间隔造口***的结构示意图；图19是图18中的房间隔造口***的消融封堵装置增加绝缘膜的结构示意图。本申请第八实施例提供的房间隔造口***的结构与第一实施例的结构相似，不同之处在于：在第八实施例中，所述房间隔造口装置20完全释放的状态下，支撑骨架21a包括圆筒状的撑开部211、设置于所述撑开部211一端的第一定位部213a，以及设置于所述撑开部211相对的另一端的第二定位部217；第一定位部213a的近端与所述撑开部211相连，远端沿所述撑开部211的轴向延伸并汇合；第二定位部217的近端与所述撑开部211相连，远端沿所述撑开部211的轴向延伸并汇合。本实施例中，支撑骨架21a为金属支撑骨架，具体的，支撑骨架21a是自膨胀式的镍合金支架。
本实施例中，支撑骨架21a为编织网状的镍钛合金支架，当房间隔造口装置20通过鞘管输送时，支撑骨架21a的直径可收缩至较小状态以便在鞘管中输送；当在心脏中释放时，可自动膨胀至所需形状尺寸，并且撑开部211能对与其接触的房间隔上的穿孔的内壁组织产生一定的径向支撑作用，并能将所述穿孔撑开以形成造口；所述第一定位部213a位于左心房内并贴合于房间隔面朝左心房的表面，所述第二定位部217位于右心房内并贴合于房间隔背朝左心房的表面，从而能将撑开部211定位于房间隔的造口内。
所述第一定位部213a包括自所述撑开部211的端边缘径向辐射延伸以形成平面状或近似平面的锥面或弧面状的定位面2132，以及连接于所述定位面2132外边缘处并朝向远离所述撑开部211的一端延伸的锥状的第一血栓抓捕笼2133。所述第一血栓抓捕笼2133的远端收口以形成一第一收口面2135，所述第一收口面2135为一圆锥状的锥面，所述第一收口面2135的远端汇合于一顶杆2136上。当使用房间隔造口装置20时，第一定位部213a位于左心房内且定位面2132与房间隔贴合，第一血栓抓捕笼2133的外表面不与房间隔相贴靠。顶杆2136用于在植入所述房间隔造口装置20时顶杆2136能顺畅地穿过房间隔上的穿孔。
所述第二定位部217包括自所述撑开部211的端边缘径向辐射延伸以形成平面状或近似平面的锥面或弧面状的定位面2172，以及连接于所述定位面2172外缘处并朝向远离所述撑开部211的一端延伸的锥状的第二血栓抓捕笼2173。所述第二血栓抓捕笼2173的远端收口以形成一第二收口面2175，所述第二收口面2175为一圆锥状的锥面，所述第二收口面2175的远端汇合于一锥顶2176上。当使用房间隔造口装置20时，第二定位部217位于右心房内且定位面2172与房间隔相贴合，第二血栓抓捕笼2173的外表面不与房间隔相贴靠，所述锥顶2176用于连接推送件52a的近端。
本实施例中消融件23包括设置于撑开部211上的第一电极231f，以及设置于第二定位部217上的第二电极233b。具体的，第一电极231f是沿所述撑开部211周向设置至少一圈连接的或间隔的环形电极，第二电极233b是设置于所述第二定位部217的定位面2172上并沿撑开部211周向设置至少一圈连接的或间隔的环形电极。具体的，所述撑开部211上的第一电极231f为连续一圈的环形电极；第二电极233b也是连续一圈的环形电极，所述环形电极与撑开部211在径向上设置有间隙，具体的，第二电极233b与撑开部211的径向距离可设置为0～5mm，优选设置3mm。每一环形电极为具有较高弹性的，柔性的金属线材或金属片，如镍钛多股丝、或黄金弹簧包裹的镍钛多股丝等结构。第一电极231f及第二电极233b均通过缝线缝合或胶粘于支撑骨架21上。
每一消融件23与支撑骨架21a之间相互绝缘。具体的，支撑骨架21a内外表面涂设有绝缘层，如镀有派瑞林绝缘涂层，从而使消融件23与支撑骨架21a相互绝缘。
在其他实施例中，所述第二定位部217的近端径向辐射延伸以形成若干定位杆，若干所述定位杆围成锥形或圆形。第一电极231f和/或第二电极233b设置于定位杆上，使第一电极231f和/或第二电极233b接触房间隔。
在其他实施例中，所述第二定位部217的近端径向辐射延伸以形成若干定位杆，若干所述定位杆围成锥形或圆形，这些定位杆上设置有若干定位点。第一电极231f和/或第二电极233b设置于若干所述 定位点上，使第一电极231f和/或第二电极233b接触房间隔。
在其他实施例中，所述第二定位部217的近端径向辐射延伸以形成定位面，所述定位面上设置有若干定位点，第一电极231f和/或第二电极233b设置于定位点上，使第一电极231f和/或第二电极233b接触房间隔。
如图19所示，在撑开部211的外壁面与第一电极231f之间设置有绝缘膜27，在第二定位部217的定位面2172与及第二电极233b之间也设置有绝缘膜27；所述撑开部211上的绝缘膜27覆盖撑开部211的外壁面一周，所述第二定位部217的定位面2172上的绝缘膜27覆盖第二定位部217的定位面2172一周，且延伸至第二血栓抓捕笼2173上。所述撑开部211上的绝缘膜27与第二定位部217的外壁面上的绝缘膜27可以是两片分离的绝缘膜，也可以合并成一片绝缘膜。通过使用绝缘膜27能隔绝消融件23和支撑骨架21a，不仅可以隔绝消融件23与支撑骨架21a之间的热量传导，防止能量传递至支撑骨架21a上，从而将能量集中在消融件23上，以对房间隔的造口内表面的组织或背朝左心房的表面于造口附近的组织进行消融，提高能量利用率；并且绝缘膜27能在电极面向血液的一侧形成绝缘屏障，减小通过血液的电流密度，减小电流对血液的加热，降低血栓形在的风险；另外，第一电极231f及第二电极233b之间的距离较短，容易控制消融件23的电流的分布，即电流仅流过第一电极231f与第二电极233b之间的房间隔的组织，能防止电流对人体的其他组织的损坏，且能够将射频能量集中用于消融的第一电极233f，达到更好的消融效果。
第一电极231f与第二电极233b均通过导线521电性连接于射频电源输出端或连接射频电源回路端，导线521的外表面绝缘处理。具体的，导线521的一端通过焊接连接于第一电极231f或第二电极233b上，所述导线521的另一端经第二血栓抓捕笼2173、锥顶2176，及推送件52a连接于射频电源输出端或连接射频电源回路端。
第一电极231f与第二电极233b的极性选择包括但不限于以下二种方案：
1.第一电极231f通过导线521连接于射频输出端口，第二电极233b通过导线521连接射频电源回路端，无中性电极板。此时，第一电极231f作为消融电极，第二电极233b作为连接射频电源回路端电极(连接射频电源回路端电极也可称为接地电极)。
2.第二电极233b通过导线521连接射频输出端口，第一电极231f通过导线521连接射频电源回路端，无中性电极板。此时，此时，第二电极233b作为消融电极，第一电极231f作为连接射频电源回路端电极。
本实施例中的房间隔造口装置20在使用时，撑开部211撑开房间隔上的穿孔以形成造口；第一血栓抓捕笼2133在左心房内展开，且定位面2132贴合于房间隔；第二血栓抓捕笼2173在右心房内展开，且定位面2172贴合于房间隔，以将房间隔的加热区域附近的三维空间区域笼罩住，防止血液因加热形成的栓子进入循环***，预防栓塞。
本实施例中的推送件52a为绝缘的高分子材料制成，房间隔造口装置20的第二定位部217的锥顶2176与推送件主体的近端通过热熔或胶粘剂相连接。所述推送件52a的内部轴向开设有穿线孔，导线521通过推送件52a内部的穿线孔延伸至尾端并与尾端连接头562电性连接，所述连接头562用于电性连接射频电源。
本实施例中的房间隔造口装置20在使用时，需与装载器、鞘管、鞘芯、射频电源及电源联接线等联合使用。使用方法如下：
房间隔穿刺后，将导丝送入到左上肺静脉内，撤去穿刺套件。将鞘芯和鞘管沿导丝推送至左心房内，撤除导丝和鞘芯。
选用合适大小的房间隔造口装置20。将推送器从装载器近端穿过，将房间隔造口装置20远端与推送器近端连接。后撤推送器将房间隔造口装置20收入装载器内。
连接装载器远端至鞘管近端，前推推送器使房间隔造口装置20输送至鞘管前端。然后缓慢推送推送器或后撤鞘管，使房间隔造口装置20的第一血栓抓捕笼2133完全张开(通过超声或DSA判断)。然后保持器械间无相对运动并向后拉动鞘管使撑开部211收容于房间隔的穿孔内，使撑开部211完全张开以撑开所述穿孔以形成造口，且第一血栓抓捕笼2133上的定位面2132紧贴在房间隔表面上。然后保持房间隔造口装置20和推送件位置不动，后撤鞘管，使第二定位部217的第二血栓抓捕笼2173完全打开，此时，第二血栓抓捕笼2173位于右心房内且定位面2172紧贴在房间隔背朝左心房的表面上。
确认撑开部211上的第一电极231f及第二定位部217上的第二电极233b均与房间隔完全贴合后，连接推送器远端到射频电源，并设置加热参数(如功率50W，持续时间30S)，然后启动加热。
加热停止后，可将房间隔造口装置20回收至鞘管并撤除体外，并测量造口直径是否达到预期。
请参阅图20，图20是本申请第九实施例提供的房间隔造口***的结构示意图。本申请第九实施 例提供的房间隔造口***的结构与第八实施例的结构相似，不同之处在于：在第九实施例中，房间隔造口装置20的第一电极231f设置于第一定位部213a上，第二电极233b设置于撑开部211上。具体的，第一电极231f是在第一定位部213a的定位面2132上沿撑开部211周向设置至少一圈连接的或间隔的环形电极，第二电极233b是在撑开部211周向设置至少一圈连接的或间隔的环形电极。
本实施例中，第一电极231f为设置于定位面2132上连续一圈的环形电极，所述环形电极与撑开部211在径向上设置有间隙，具体的，所述环形电极与撑开部211的径向距离可设置为0～5mm，优选设置3mm；第二电极233b是设置于撑开部211上连续一圈的环形电极；每一环形电极为具有较高弹性的，柔性的金属线材或金属片，如镍钛多股丝、或黄金弹簧包裹的镍钛多股丝等结构。第一电极231f及第二电极233b均通过缝线缝合或胶粘于支撑骨架21a上。
第一电极231f可以通过导线521电性连接于射频电源输出端，第二电极233b通过导线521连接射频电源回路端，此时，第一电极231f作为消融电极，第二电极233b作为连接射频电源回路端电极；或者第二电极233b可以通过导线521电性连接于射频电源输出端，第一电极231f通过导线421连接射频电源回路端，第二电极233b作为消融电极，第一电极231f作为连接射频电源回路端电极。在撑开部211的外壁面与对应的第二电极233b之间设置有绝缘膜27，在第一定位部213a的定位面2132与对应的第一电极231f之间也设置有绝缘膜27。所述第一定位部213a的外壁面上的绝缘膜27覆盖定位面2132一周，且延伸至第一血栓抓捕笼2133上。所述撑开部211上的绝缘膜27与第一定位部213a的定位面2132上的绝缘膜27可以是两片分离的绝缘膜，也可以合并成一片绝缘膜。通过使用绝缘膜27能隔绝消融件23和支撑骨架21a，不仅可以隔绝消融件23与支撑骨架21a之间的热量传导，防止能量传递至支撑骨架21a上，从而将能量集中在消融件23上，以对房间隔的造口内表面的组织或面朝左心房的表面于造口附近的组织进行消融，提高能量利用率；并且绝缘膜27能在电极面向血液的一侧形成绝缘屏障，减小通过血液的电流密度，减小电流对血液的加热，降低血栓形在的风险；另外，第一电极231f及第二电极233b之间的距离较短，容易控制消融件23的电流的分布，即电流仅流过第一电极231f与第二电极233b之间的房间隔的组织，能防止电流对人体的其他组织的损坏。
本实施例中的房间隔造口***在使用时，需与装载器、鞘管、鞘芯、可导电的推送器、射频电源及电源联接线等联合使用。具体的使用流程及方法与第六实施例相同，在此不再赘述。
请参阅图21，图21是本申请第十实施例提供的房间隔造口***的结构示意图。本申请第十实施例提供的房间隔造口***的结构与第八实施例的结构相似，不同之处在于：在第十实施例中，房间隔造口装置20的消融件23的第一电极231f设置于第一定位部213a上，第二电极233b设置于第二定位部217上。具体的，第一电极231f是在第一定位部213a的定位面2132上沿撑开部211周向设置至少一圈连接的或间隔的环形电极，第二电极233b是在第二定位部217的定位面2172上沿撑开部211周向设置至少一圈连接的或间隔的环形电极。
本实施例中，第一电极231f为设置在第一定位部213a的定位面2132上的围绕撑开部211周向连续一圈的环形电极，所述环形电极与撑开部211在径向上设置有间隙，具体的，所述环形电极与撑开部211的径向距离可设置为0～5mm，优选设置3mm。第二电极233b为设置在所述第二定位部217的定位面2172上的围绕撑开部211周向连续一圈的环形电极，所述环形电极与撑开部211在径向上设置有间隙，具体的，所述环形电极与撑开部211的径向距离可设置为0～5mm，优选设置3mm。每一环形电极为具有较高弹性的，柔性的金属线材或金属片，如镍钛多股丝、或黄金弹簧包裹的镍钛多股丝等结构。第一电极231f及第二电极233b均通过缝线缝合或胶粘于支撑骨架21a上。
第一电极231f通过导线电性连接于射频电源输出端，第二电极233b通过导线连接射频电源回路端，第一电极231f作为消融电极，第二电极233b作为连接射频电源回路端电极；或者第二电极233b通过导线电性连接于射频电源输出端，第一电极231f通过导线连接射频电源回路端，第二电极233b作为消融电极，第一电极231f作为连接射频电源回路端电极。
进一步的，在第一定位部213a的定位面2132与第一电极231f之间设置有绝缘膜27；在第二定位部217的定位面2172与第二电极233b之间也设置有绝缘膜27。通过使用绝缘膜27能隔绝消融件23和支撑骨架21a，不仅可以隔绝消融件23与支撑骨架21a之间的热量传导，防止能量传递至支撑骨架21a上，从而将能量集中在消融件23上，以对房间隔面朝左心房的表面于造口附近的组织或背朝左心房的表面于造口附近的组织均进行消融，提高能量利用率；并且绝缘膜27能在环形电极面向血液的一侧形成绝缘屏障，减小通过血液的电流密度，减小电流对血液的加热，降低血栓形在的风险；另外，第一电极231f及第二电极233b之间的距离较短，容易控制消融件23的电流的分布，即电流仅流过第一电极231f与第二电极233b之间的房间隔的组织，能防止电流对人体的其他组织的损坏，且能够将射频能量集中用于消融的消融件23，达到更好的消融效果。
本实施例中的房间隔造口***在使用时，需与装载器、鞘管、鞘芯、可导电的推送器、射频电源及电源联接线等联合使用。具体的使用流程及方法与第六实施例相同，在此不再赘述。
在其他实施例中，撑开部211的外壁面上也可以覆盖一周绝缘膜，所述撑开部211、第一定位部213a及第二定位部217上的绝缘膜可以制作成一体结构。
请参阅图22-图25，图22是本申请第十一实施例提供的房间隔造口***的结构示意图；图23是图22中的房间隔造口***的消融封堵装置增加绝缘膜的结构示意图；图24是图23中沿XXIV-XXIV线的剖视图；图25是图24中XXV部分的放大图。本申请第十一实施例提供的房间隔造口***的结构与第八实施例的结构相似，不同之处在于：在第十一实施例中，在房间隔造口装置20完全释放的状态下，支撑骨架21b包括内凹的回转曲面的撑开部211、设置于所述撑开部211一端的第一定位部213b，以及设置于所述撑开部211相对的另一端的第二定位部217a。所述第一定位部213b的近端与所述撑开部211相连，远端径向辐射延伸；所述第二定位部217a的近端与所述撑开部211相连，远端沿撑开部211的轴向延伸并汇合。本实施例中，支撑骨架21b为金属支撑骨架，具体的，支撑骨架21b是自膨胀式的镍合金支架。
本实施例中，支撑骨架21b为编织网状的镍钛合金支架，第一定位部213b为单层编织网结构，第二定位部217a为双层编织网结构。当房间隔造口装置20通过鞘管输送时，支撑骨架21b的直径可收缩至较小状态以便在鞘管中输送；当在心脏中释放时，可自动膨胀至所需形状尺寸，并且撑开部211能对与其接触的房间隔的穿孔内壁组织产生一定的径向支撑作用，能将房间隔的穿孔撑开以形成造口；所述第一定位部213b位于左心房内且贴合于房间隔面朝左心房的表面，所述第二定位部217a位于右心房内且贴合于房间隔背朝左心房的表面，从而将撑开部211定位于房间隔的造口内。
所述第一定位部213b包括自所述撑开部211的端边缘径向辐射延伸形成的圆锥形或圆形的一定位面2132，以及自定位面2132外缘向远端弯曲的弯曲框2134，所述弯曲框2134朝远端圆滑过渡弯曲，避免损伤心房组织。
所述第二定位部217a包括自所述撑开部211的端边缘径向朝外辐射延伸以形成的圆锥形或圆形的一定位面2172，以及连接于所述定位面2172外缘处并朝向远离所述撑开部211的一端延伸的圆锥状的第二血栓抓捕笼2173。所述第二血栓抓捕笼2173的远端收口并汇合于一锥顶2176上。所述锥顶2176用于连接推送件52a的近端。
本实施例中的消融件23包括设置于第二定位部217a的定位面2172上的第一电极231f，及设置于第一定位部213b的定位面2132上的第二电极233b。具体的，第一电极231f是沿撑开部211周向设置至少一圈连接的或间隔的环形电极，所述环形电极与撑开部211在径向上设置有间隙，具体的，所述环形电极与撑开部211的径向距离可设置为0～5mm，优选设置3mm。第一电极231f为具有较高弹性的，柔性的金属线材或金属片，如镍钛多股丝、或黄金弹簧包裹的镍钛多股丝等结构。第一电极231f通过缝线缝合或胶粘于第二定位部217a的定位面2172上。
第二电极233b是设置于定位面2132上的电性裸露区域，即支撑骨架21b的镍钛合金在定位面2132上对应第二电极233b的区域没有涂设绝缘涂层，所述定位面2132上电性裸露的镍钛合金区域可以是沿撑开部211周向设置连接的或间隔的至少一圈。本实施例中，第二电极233b是沿撑开部211周向连接的设置一圈的电性裸露的环状镍钛合金区域，所述环状镍钛合金区域与撑开部211在径向上设置有间隙，具体的所述环状镍钛合金区域与撑开部211的径向距离可设置为0～5mm，优选设置3mm。
第一电极231f通过导线521电性连接于射频电源输出端，导线521的外表面绝缘处理。具体的，导线521的一端通过焊接连接于第一电极231f上，导线521的另一端经第二定位部217a、锥顶2176，推送件52a及连接头562连接于射频电源输出端。第二电极233b通过导线521连接射频电源回路端。具体的，导线521的一端焊接于支撑骨架21b的锥顶2176，使支撑骨架21b电性连接于导线521，所述导线的另一端经推送件52a及连接头562连接射频电源回路端。此时，第一电极231f作为消融电极，第二电极233b作为连接射频电源回路端电极。
在其他实施例中，第一电极231f通过导线521连接射频电源回路端，第二电极233b通过导线521电性连接于射频电源输出端。具体的，导线521的外表面绝缘处理，导线521的一端通过焊接连接于第一电极231f上，导线521的另一端经第二定位部217a、锥顶2176，推送件52a及连接头562连接射频电源回路端；另一导线521的一端焊接于支撑骨架21b的锥顶2176，使支撑骨架21b电性连接于导线521，所述导线521的另一端经推送件52a及连接头562连接于射频电源输出端。此时，第二电极233b作为消融电极，第一电极231f作为连接射频电源回路端电极。
在其他实施例中，所述定位面2132上设置有若干定位点，这些定位点设置为电性裸露区域。
在其他实施例中，所述第一定位部213b的近端径向辐射延伸以形成若干定位杆，若干所述定位杆 围成锥形或圆形。这些定位杆接触房间隔的表面设置电性裸露区域。
在其他实施例中，所述第一定位部213b的近端径向辐射延伸以形成若干定位杆，定位杆上设置有若干定位点，这些定位点设置为电性裸露区域。
如图23所示，消融件23与支撑骨架21b之间相互绝缘，具体的，支撑骨架21b上除设置为第二电极233b以外的表面全部涂设有绝缘涂层，如镀有派瑞林绝缘涂层，从而使消融件23与支撑骨架21b相互绝缘。进一步的，在第二定位部217a的外壁面全部覆盖有绝缘膜27，所述绝缘膜27将第一电极231f与支撑骨架21b绝缘。所述第一定位部213b的背朝所述撑开部211的侧面对应第二电极233b处涂设有绝缘涂层，所述绝缘涂层可以是但不限于派瑞林涂层、聚四氟乙烯涂层、聚氨酯涂层、或聚酰亚胺涂层。通过使用绝缘膜27能隔绝第一电极231f和支撑骨架21b，不仅可以隔绝消融件23与支撑骨架21b之间的热量传导，防止能量传递至支撑骨架21b上，从而将能量集中在消融件23上，以对房间隔面朝左心房的表面于造口附近的组织及背朝左心房的表面于造口附近的组织均进行消融，提高能量利用率；并且绝缘膜27及绝缘涂层能在电极面向血液的一侧形成绝缘屏障，减小通过血液的电流密度，减小电流对血液的加热，降低血栓形在的风险；另外，电流仅流过第一电极231f与第二电极233b之间的房间隔的组织，能防止电流对人体的其他组织的损坏，且能够将射频能量集中用于消融的消融件23，达到更好的消融效果。
在其他实施例中，所述第一定位部213b背朝所述撑开部211的侧面对应第二电极233b的区域设置有绝缘膜，所述绝缘膜通过缝线缝合或胶粘于所述支撑骨架上。
本实施例中的第一电极231f与第二电极233b的极性选择包括但不限于以下二种方案：
1.第一电极231f通过导线521连接射频输出端口，第二电极233b通过导线521连接射频电源回路端，无中性电极板。此时，第一电极231f作为消融电极，第二电极233b作为连接射频电源回路端电极。
2.第二电极233b通过导线521连接射频输出端口，第一电极231f通过导线连接射频电源回路端，无中性电极板。此时，第二电极233b作为消融电极，第一电极231f作为连接射频电源回路端电极。
本实施例中的房间隔造口***在使用时，需与装载器、鞘管、鞘芯、可导电的推送器、射频电源输出端及电源联接线、中性电极板等联合使用。具体的使用流程及方法与第六实施例相同，在此不再赘述。
请参阅图26及图27，图26是本申请第十二实施例提供的房间隔造口***的结构示意图；图27是图26中的房间隔造口***的消融封堵装置增加绝缘膜的结构示意图。本申请第十二实施例提供的房间隔造口***的结构与第八实施例的结构相似，不同之处在于：在房间隔造口装置20完全释放的状态下，所述支撑骨架21c包括圆筒状的撑开部211、设置于所述撑开部211一端的第一定位部213c，以及设置于所述撑开部211相对的另一端的第二定位部217b；所述第一定位部213c的近端与所述撑开部211相连，远端沿撑开部211的轴向延伸并汇合；所述第二定位部217的近端与所述撑开部211相连，远端沿撑开部211的轴向延伸并汇合。所述第一定位部213c和第二定位部217b均为双层编织网结构。
本实施例中，支撑骨架21c为编织网状的镍钛合金支架，当房间隔造口装置20通过鞘管输送时，支撑骨架21c的直径可收缩至较小状态以便在鞘管中输送；当在心脏中释放时，可自动膨胀至所需形状尺寸，并且撑开部211能对与其接触的房间隔的穿孔的内壁组织产生一定的径向支撑作用，并能将房间隔的穿孔撑开以形成造口；所述第一定位部213c位于左心房内且贴合于房间隔面朝左心房的表面，所述第二定位部217b位于右心房内且贴合于房间隔背朝左心房的表面，从而将撑开部211定位于房间隔的造口内。
所述第一定位部213c包括自所述撑开部211的端边径向朝外辐射延伸以形成的一定位面2132，以及连接于所述定位面2132外缘处并朝远离所述撑开部211的一端延伸的圆锥状的第一血栓抓捕笼2133。所述定位面2132可以为平面状或近似平面的锥面或弧面状，所述第一血栓抓捕笼2133的外表面不与房间隔相贴靠。所述第一血栓抓捕笼2133的远端收口汇合于一顶杆2136上，所述顶杆2136用于在植入所述房间隔造口装置20时顶杆2136能顺畅地穿过房间隔上的穿孔。
所述第二定位部217b包括自所述撑开部211的端边径向朝外辐射延伸以形成的一定位面2172，以及连接于所述定位面2172外缘处并朝向远离所述撑开部211的一端延伸的圆锥状的第二血栓抓捕笼2173。所述定位面2172可以为平面状或近似平面的锥面或弧面状，所述第二定位部217b的外表面不与房间隔相贴靠。所述第二血栓抓捕笼2173的远端收口并汇合于一锥顶2176上，所述锥顶2176用于连接推送件52a的近端。
本实施例中消融件23包括两个第一电极231f及一个第二电极233b，两个第一电极231f分别设置于第一定位部213c的定位面2132及第二定位部217b的定位面定位面2172，第二电极233b设置于撑开部211的外壁面上。具体的，所述第一定位部213c的定位面2132上的第一电极231f是设置于支撑骨架 21c的定位面2132上的电性裸露区域，即支撑骨架21c的外表面除所述电性裸露区域外均涂设有绝缘涂层，所述定位面2132上的电性裸露区域是沿撑开部211周向连接的或间隔的设置至少一圈。本实施例中，第一定位部213c上的第一电极231f是沿撑开部211周向连接的设置一圈，第一电极231f与撑开部211的径向距离可设置为0～5mm，优选设置3mm。所述第二定位部217b的定位面2172上的第一电极231f是设置于支撑骨架21c的定位面2172上的电性裸露区域，即支撑骨架21c的外表面除所述电性裸露区域外均涂设有绝缘涂层，所述定位面2172上的电性裸露区域是沿撑开部211周向连接的或间隔的设置至少一圈。本实施例中，第二定位部217b上的第一电极231f是沿撑开部211周向连接的设置一圈，所述第一电极231f与撑开部211的径向距离可设置为0～5mm，优选设置3mm。
所述撑开部211上的第二电极233b是沿所述撑开部211周向设置至少一圈连接的或间隔的环形电极，具体的，第二电极233b为连续一圈的环形电极，所述环形电极为具有较高弹性的，柔性的金属线材或金属片，如镍钛多股丝、或黄金弹簧包裹的镍钛多股丝等结构。第二电极233b通过缝线缝合或胶粘于支撑骨架21c上。
两个第一电极231f通过导线521电性连接于射频电源输出端，具体的，导线521的一端焊接于支撑骨架21c的锥顶2176处，使支撑骨架21c电性连接于导线521，所述导线521的另一端经推送件52连接于射频电源输出端。第二电极233b通过另一导线521连接射频电源回路端，具体的，导线521的一端通过焊接连接于第二电极233b上，导线521的另一端经第二血栓抓捕笼2173、锥顶2176、推送件52a，及连接头562连接射频电源回路端。此时，两个第一电极231f均为消融电极，第二电极233b为连接射频电源回路端电极。
本实施例中的房间隔造口***在使用时，需与装载器、鞘管、鞘芯、可导电的推送器、射频电源输出端及电源联接线等联合使用。具体的使用流程及方法与第六实施例相同，在此不再赘述。
在其他实施例中，两个第一电极231f通过导线521连接射频电源回路端，具体的，导线521的一端焊接于支撑骨架21c的锥顶2176处，使支撑骨架21c电性连接于导线521，所述导线的另一端经推送件52连接射频电源回路端。第二电极233b通过另一导线521连接于射频电源输出端，具体的，导线521的一端通过焊接连接于第二电极233b上，导线521的另一端经第二血栓抓捕笼2173、锥顶2176、推送件52a，及连接头562连接于射频电源输出端。此时，两个第一电极231f均为连接射频电源回路端电极，第二电极233b为消融电极。
在其他实施例中，所述定位面2172上设置有若干定位点，这些定位点设置为电性裸露区域。
在其他实施例中，所述第二定位部217b的近端径向辐射延伸以形成若干定位杆，若干所述定位杆围成锥形或圆形。这些定位杆接触房间隔的表面设置电性裸露区域。
在其他实施例中，所述第二定位部217b的近端径向辐射延伸以形成若干定位杆，定位杆上设置有若干定位点，这些定位点设置为电性裸露区域。
如图27所示，撑开部211与第二电极233b之间设置有绝缘膜27，即绝缘膜27覆盖于撑开部211的外壁面一周，使所述绝缘膜27将第二电极233b与支撑骨架21c绝缘。所述第一定位部213c及第二定位部217b的内外表面除第一电极231f的区域外均涂设有绝缘涂层，所述绝缘涂层可以是但不限于派瑞林涂层、聚四氟乙烯涂层、聚氨酯涂层、或聚酰亚胺涂层。
请参阅图28，图28是本申请第十三实施例提供的房间隔造口***的结构示意图。本申请第十三实施例提供的房间隔造口***的结构与第八实施例的结构相似，不同之处在于：在第十三实施例中设置有三个电极，三个电极中可以包括两个第一电极231f和一个第二电极233b，或者两个第二电极233b和一个第一电极231f。第一电极231f及第二电极233b可以同时设置所述撑开部211的外壁面、所述第一定位部213a的定位面2132、所述第二定位部217的定位面2172的三者之一上；第一电极231f及第二电极233b也可以分别设置于所述撑开部211的外壁面、所述第一定位部213a的定位面2132、所述第二定位部217的定位面2172的三者之二上；三个电极还可以分别设置于所述撑开部211的外壁面、所述第一定位部213a的定位面2132、所述第二定位部217的定位面2172。
本实施列中，消融件23包括两个第一电极231f和一个第二电极233b，两个第一电极231f分别设置于第一定位部213a的定位面2132上，以及撑开部211的外壁面，第二电极233b设置于第二定位部217的定位面2172上。具体的，第一定位部213a的定位面2132上的第一电极231f是设置于定位面2132上并沿撑开部211周向设置至少一圈连接的或间隔的环形电极；撑开部211上的第一电极231f是沿所述撑开部211周向设置至少一圈连接的或间隔的环形电极；第二定位部217的定位面2172的第二电极233b是设置于定位面2172上并沿撑开部211周向设置至少一圈连接的或间隔的环形电极。每一环形电极为具有较高弹性的，柔性的金属线材或金属片，如镍钛多股丝、或黄金弹簧包裹的镍钛多股丝等结构。每一环形电极通过缝线缝合或胶粘于支撑骨架21a上。
消融件23与支撑骨架21a之间相互绝缘，具体的，在撑开部211的外壁面与对应的第一电极231f之间设置有绝缘膜27，在第一定位部213a的外壁面与对应的第一电极231f之间也设置有绝缘膜27，以及在第二定位部217的外壁面与第二电极233b之间也设置有绝缘膜27。具体的，所述撑开部211上的绝缘膜27覆盖撑开部211的外壁面一周；所述第一定位部213a的外壁面上的绝缘膜27覆盖第二定位部213a的定位面2132，且延伸至第一血栓抓捕笼2133上；所述第二定位部217的外壁面上的绝缘膜27覆盖第二定位部217的定位面2172，且延伸至第二血栓抓捕笼2173上。三个绝缘膜27可以是三片分离的绝缘膜，也可以合并成一片绝缘膜。通过使用绝缘膜27能隔绝消融件23和支撑骨架21a，不仅可以隔绝消融件23与支撑骨架21a之间的热量传导，防止能量传递至支撑骨架21a上，从而将能量集中在消融件23上，以对房间隔的造口内表面的组织、面朝左心房的表面于造口附近的组织进行消融，提高能量利用率；并且绝缘膜27能在电极面向血液的一侧形成绝缘屏障，减小通过血液的电流密度，减小电流对血液的加热，降低血栓形在的风险；电流仅流过第一电极231f与第二电极233b之间的房间隔的组织，能防止电流对人体的其他组织的损坏，且能够将射频能量集中用于消融的消融件23，达到更好的消融效果。
支撑骨架21a上的两个第一电极231f和第二电极233b的极性选择包括但不限于以下四种方案：
1.两个第一电极231f通过导线521电性连接于射频输出端口，第二电极233b通过导线521连接射频电源回路端。
2.第二电极233b通过导线521电性连接射频输出端口，两个第一电极231f通过导线521连接射频电源回路端。
3.其中一个第一电极231f与第二电极233b通过导线521连接射频输出端口，另一个第一电极231f通过导线521连接射频电源回路端。
4.两个第一电极231f和第二电极233b分别连接三相电压源A相、B相、C相输出端口，三个端口输出三路等幅值、同频率、相位角依次相差120°的正弦交流电，中性电极板连接射频电源回路端。
本实施例中的房间隔造口***在使用时，需与装载器、鞘管、鞘芯、可导电的推送器、射频电源输出端及电源联接线、中性电极板等联合使用。具体的使用流程及方法与第六实施例相同，在此不再赘述。
以上是本申请实施例的实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本申请实施例原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也视为本申请的保护范围。

Claims (21)

  1. 一种改进消融方式的房间隔造口装置，其包括用于扩张房间隔上的穿孔的支撑骨架，其特征在于，所述房间隔造口装置还包括设置于所述支撑骨架上的消融件，所述消融件包括第一电极及第二电极，所述第一电极与第二电极中的其中一电极电性连接于射频电源输出端，另一电极连接射频电源回路端，以形成电流回路接收射频电源的能量对房间隔进行消融。
  2. 根据权利要求1所述的房间隔造口装置，其特征在于，所述支撑骨架包括用于扩张所述穿孔的撑开部，以及设置于所述撑开部端部的定位部，所述第一电极及所述第二电极同时设置于所述撑开部、所述定位部二者之一上；或所述第一电极及所述第二电极分别设置于所述撑开部及所述定位部上。
  3. 根据权利要求2所述的房间隔造口装置，其特征在于，所述定位部设置有接触所述房间隔的定位面、定位线或者定位点，所述第一电极和/或第二电极设置于所述定位面、定位线或者定位点上。
  4. 根据权利要求2所述的房间隔造口装置，其特征在于，所述支撑骨架是金属支撑骨架，所述支撑骨架上设置有接触房间隔的电性裸露区域，所述支撑骨架电性连接于射频电源输出端或连接射频电源回路端，使所述电性裸露区域形成所述消融件的第一电极或第二电极。
  5. 根据权利要求4所述的房间隔造口装置，其特征在于，所述支撑骨架的外表面除所述电性裸露区域外都涂设有绝缘涂层。
  6. 根据权利要求4所述的房间隔造口装置，其特征在于，所述电性裸露区域设置于所述撑开部的外壁面上，所述电性裸露区域沿所述撑开部的外壁面周向设置连接的或间断的至少一圈。
  7. 根据权利要求4所述的房间隔造口装置，其特征在于，所述定位部包括接触房间隔的定位面、定位线或者定位点，所述电性裸露区域设置于所述定位面、定位线或者定位点上，所述电性裸露区域沿所述撑开部的周向设置连接的或间断的至少一圈。
  8. 根据权利要求2所述的房间隔造口装置，其特征在于，所述第一电极和/或第二电极是设置于所述撑开部的外壁面和/或所述定位部上的环状电极，所述环状电极沿所述撑开部的外壁面周向设置连接的或间断的至少一圈。
  9. 根据权利要求2所述的房间隔造口装置，其特征在于，所述第一电极和/或第二电极是设置于所述撑开部上或所述定位部上的若干点状电极或者条状电极，若干所述点状电极或者条状电极环绕所述支撑骨架一圈，若干所述点状电极或者条状电极通过导线串联后连接于射频电源回路端或者输出端。
  10. 根据权利要求8或9所述的房间隔造口装置，其特征在于，所述消融件与所述支撑骨架之间进行绝缘处理。
  11. 根据权利要求10所述的房间隔造口装置，其特征在于，所述支撑骨架的外表面涂设有绝缘涂层。
  12. 根据权利要求10所述的房间隔造口装置，其特征在于，与射频电源电性连接的第一电极或第二电极与支撑骨架之间设置有绝缘膜。
  13. 根据权利要求10所述的房间隔造口装置，其特征在于，与射频电源电性连接的第一电极或第二电极与支撑骨架之间设置绝缘涂层。
  14. 根据权利要求2所述的房间隔造口装置，其特征在于，所述支撑骨架上于所述撑开部的外壁面上周向设置有至少一圈的显影标志。
  15. 根据权利要求1所述的房间隔造口装置，其特征在于，所述支撑骨架包括用于撑开所述穿孔的撑开部、位于所述撑开部一端的第一定位部，以及位于所述撑开部相对的另一端的第二定位部，所述第一电极及第二电极一同设置所述撑开部、所述第一定位部、所述第二定位部的三者之一上；或第一电极及第二电极分别设置于所述撑开部、所述第一定位部、所述第二定位部的三者之二上。
  16. 根据权利要求15所述的房间隔造口装置，其特征在于，所述第一电极及第二电极是沿所述撑开部的外壁面设置连接的或间断的至少一圈的环状电极。
  17. 根据权利要求15所述的房间隔造口装置，其特征在于，所述第一定位部及第二定位部均设置有接触房间隔表面的定位面、定位线或者定位点，所述第一电极及所述第二电极一同设置于第一定位部的定位面、定位线或者定位点或所述第二定位部的定位面、定位线或者定位点；或所述第一电极及所述第二电极分别设置于第一定位部及第二定位部的定位面、定位线或者定位点上。
  18. 根据权利要求17所述的房间隔造口装置，其特征在于，所述支撑骨架是金属支撑骨架，所述金属支撑骨架的撑开部的外壁面、第一定位部的定位面、定位线或者定位点、第二定位部的定位面、定位线或者定位点的三者之一上设置有电性裸露区域，所述支撑骨架电性连接于射频电源输出端或连接射频电源回路端，使所述电性裸露区域形成所述消融件的第一电极或第二电极。
  19. 根据权利要求17所述的房间隔造口装置，其特征在于，所述支撑骨架是金属支撑骨架，所述 金属支撑骨架的撑开部的外壁面、第一定位部的定位面、定位线或者定位点、第二定位部的定位面、定位线或者定位点的三者之二上分别设置有电性裸露区域，所述支撑骨架电性连接于射频电源输出端或连接射频电源回路端，使两个电性裸露区域一同形成所述消融件的第一电极或第二电极。
  20. 根据权利要求17所述的房间隔造口装置，其特征在于，所述第一定位部还包括连接于所述第一定位部和/或第二定位部的定位面外边缘的第一血栓抓捕装置。
  21. 一种房间隔造口***，其特征在于，其包括权利要求1-20任意一项所述的房间隔造口装置、控制所述房间隔造口装置的造口装置控制机构及射频电源，所述射频电源通过造口装置控制机构与房间隔造口装置电连接。
PCT/CN2019/116191 2018-11-09 2019-11-07 改进消融方式的房间隔造口装置及房间隔造口*** WO2020094087A1 (zh)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
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***
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***
CN201821851963.2 2018-11-09
CN201811336798.1 2018-11-09

Publications (1)

Publication Number Publication Date
WO2020094087A1 true WO2020094087A1 (zh) 2020-05-14

Family

ID=70611688

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2019/116191 WO2020094087A1 (zh) 2018-11-09 2019-11-07 改进消融方式的房间隔造口装置及房间隔造口***

Country Status (1)

Country Link
WO (1) WO2020094087A1 (zh)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022191076A1 (ja) 2021-03-08 2022-09-15 テルモ株式会社 医療デバイス
WO2022191075A1 (ja) 2021-03-08 2022-09-15 テルモ株式会社 医療デバイス
US11622695B1 (en) 2020-04-23 2023-04-11 Shifamed Holdings, Llc Intracardiac sensors with switchable configurations and associated systems and methods
US11633194B2 (en) 2020-11-12 2023-04-25 Shifamed Holdings, Llc Adjustable implantable devices and associated methods
US11801369B2 (en) 2020-08-25 2023-10-31 Shifamed Holdings, Llc Adjustable interatrial shunts and associated systems and methods

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100152732A1 (en) * 2007-08-28 2010-06-17 Terumo Kabushiki Kaisha Medical device
CN103519888A (zh) * 2013-10-30 2014-01-22 上海魅丽纬叶医疗科技有限公司 兼具测温功能和测阻抗功能的射频电极和射频消融仪
CN104224315A (zh) * 2014-08-05 2014-12-24 上海魅丽纬叶医疗科技有限公司 具有网管状支架结构的射频消融导管及其设备
CN107334512A (zh) * 2011-02-10 2017-11-10 可维亚媒体公司 用于建立和保持房内压力释放孔的装置
US20180193084A1 (en) * 2010-05-05 2018-07-12 Ablacor Medical Corporation Cardiac ablation system

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100152732A1 (en) * 2007-08-28 2010-06-17 Terumo Kabushiki Kaisha Medical device
US20180193084A1 (en) * 2010-05-05 2018-07-12 Ablacor Medical Corporation Cardiac ablation system
CN107334512A (zh) * 2011-02-10 2017-11-10 可维亚媒体公司 用于建立和保持房内压力释放孔的装置
CN103519888A (zh) * 2013-10-30 2014-01-22 上海魅丽纬叶医疗科技有限公司 兼具测温功能和测阻抗功能的射频电极和射频消融仪
CN104224315A (zh) * 2014-08-05 2014-12-24 上海魅丽纬叶医疗科技有限公司 具有网管状支架结构的射频消融导管及其设备

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11622695B1 (en) 2020-04-23 2023-04-11 Shifamed Holdings, Llc Intracardiac sensors with switchable configurations and associated systems and methods
US11801369B2 (en) 2020-08-25 2023-10-31 Shifamed Holdings, Llc Adjustable interatrial shunts and associated systems and methods
US11633194B2 (en) 2020-11-12 2023-04-25 Shifamed Holdings, Llc Adjustable implantable devices and associated methods
US11857197B2 (en) 2020-11-12 2024-01-02 Shifamed Holdings, Llc Adjustable implantable devices and associated methods
WO2022191076A1 (ja) 2021-03-08 2022-09-15 テルモ株式会社 医療デバイス
WO2022191075A1 (ja) 2021-03-08 2022-09-15 テルモ株式会社 医療デバイス

Similar Documents

Publication Publication Date Title
US20200238059A1 (en) Devices, systems, and methods for interatrial shunts
WO2020094087A1 (zh) 改进消融方式的房间隔造口装置及房间隔造口***
CN209059540U (zh) 心房间的压力调节装置
CN108784896B (zh) 房间隔造口装置、房间隔造口***及其操作方法
CN209360888U (zh) 房间隔造口装置及其房间隔造口***
WO2020259492A1 (zh) 房间隔造口装置
US20200008870A1 (en) Ablation and occlusive system
EP3019105B1 (en) Devices for nerve modulation
WO2019109013A1 (en) Transcatheter device for interatrial anastomosis
CN111166463A (zh) 改进消融方式的房间隔造口装置及房间隔造口***
CN105615993A (zh) 具有用于标测和消融管状区域的软的远侧末端的导管
WO2020094085A1 (zh) 改进消融效果的房间隔造口装置及房间隔造口***
CN111166461A (zh) 房间隔造口装置及其房间隔造口***
JP2010540198A (ja) 経中隔心臓処置のためのシステムおよび方法
CN111166462A (zh) 改进消融效果的房间隔造口装置及房间隔造口***
WO2022171142A1 (zh) 消融导管、消融装置及消融***
CN212346702U (zh) 多组件房间隔造口***及其房间隔造口装置
CN112754650A (zh) 改进安全性的心脏房间隔分流***
CN212165887U (zh) 心脏房间隔分流***
CN110215253A (zh) 左心耳封堵消融装置
CN208892867U (zh) 房间隔造口装置及其房间隔造口***
CN110215254A (zh) 一种左心耳封堵消融装置
CN212346703U (zh) 可调式房间隔造口装置
CN209611297U (zh) 改进消融方式的房间隔造口装置及房间隔造口***
WO2022135424A1 (zh) 左心耳消融装置及控制方法

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 19882774

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 19882774

Country of ref document: EP

Kind code of ref document: A1

122 Ep: pct application non-entry in european phase

Ref document number: 19882774

Country of ref document: EP

Kind code of ref document: A1