WO2022113054A1 - Dispositif de création de stomie et système de création de stomie - Google Patents

Dispositif de création de stomie et système de création de stomie Download PDF

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Publication number
WO2022113054A1
WO2022113054A1 PCT/IB2021/061139 IB2021061139W WO2022113054A1 WO 2022113054 A1 WO2022113054 A1 WO 2022113054A1 IB 2021061139 W IB2021061139 W IB 2021061139W WO 2022113054 A1 WO2022113054 A1 WO 2022113054A1
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WO
WIPO (PCT)
Prior art keywords
stoma
ablation
wire
ostomy device
sheath core
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PCT/IB2021/061139
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English (en)
Chinese (zh)
Inventor
高国庆
潘晓彤
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杭州诺生医疗科技有限公司
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Publication of WO2022113054A1 publication Critical patent/WO2022113054A1/fr

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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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • 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
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00595—Cauterization
    • 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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00702—Power or energy
    • 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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00714—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1407—Loop
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe

Definitions

  • Atrial septal ostomy is performed by forming a stoma on the atrial septal tissue between the left atrium and the right atrium of the patient, so as to form a shunt between the left and right atrium, so as to improve the prognosis of patients with heart failure or pulmonary hypertension. symptom.
  • the traditional method of atrial septal stoma is by implanting a shunt device at the atrial septal stoma.
  • a shunt device is implanted at the atrial septal puncture site to keep the shunt opening unobstructed.
  • the shunt device easily leads to the formation of blood test, and the endothelium is easy to climb and adhere to the shunt device, which may easily cause the shunt opening to be blocked, thereby losing the shunt function of the left and right atrium.
  • the ostomy is performed on the atrial septum with an ostomy device and the stoma device is withdrawn after the operation.
  • the ostomy appliance includes a cutting device and a grasping device.
  • the grasping device first locates and grasps the tissue to be cut, and then the cutting part of the cutting device cuts the part of the tissue grasped by the grasping device, and the cut part of the tissue is taken by the grasping device. out of the body to form a stoma.
  • the grasping device is prone to loosening during the operation, resulting in damage to other myocardial tissue, and when the grasping device is recovered, the cut tissue may fall off, resulting in the formation of embolism.
  • the existing atrial septal tissue stoma method requires mechanical puncture of the atrial septal tissue before the stoma, which is not only difficult to puncture, but also easily causes the atrial septal tissue to tear.
  • embodiments of the present invention need to provide an ostomy device and an ostomy system to solve the above technical problems.
  • an embodiment of the present invention provides an ostomy device, comprising an expandable stoma member and a sheath core passing through the stoma member, the stoma member including a stoma portion, and the sheath core remote settings
  • a first ablation piece electrically connected to the ablation power source, and the first ablation piece is used for ablation of the tissue, so that the stoma part is passed through the puncture of the tissue and expanded to stretch the tissue.
  • an embodiment of the present invention provides an ostomy system, including a control handle, a sheath, and the ostomy device as described above, the control handle is externally connected to the ablation energy source, and the control handle is used to control the ostomy
  • the mouthpiece and the sheath core are movably accommodated in the sheath tube or extend out of the sheath tube.
  • FIG. 1 is a schematic structural diagram of an atrial septal tissue stoma system provided by a first embodiment of the present invention.
  • FIG. 2 is a cross-sectional view of a partial structure of the sheath core of the atrial septostomy system in FIG. 1 .
  • FIG. 3 is a cross-sectional view of the sheath core in FIG. 2 taken along the line III-III.
  • FIG. 4 is a schematic structural diagram of the stoma component of the atrial septal tissue stoma system in FIG. 1 .
  • FIG. 5 is a schematic structural diagram of the atrial septal tissue stoma system provided by the second embodiment of the present invention.
  • FIG. 6 is a cross-sectional view of a partial structure of the sheath core of the atrial septostomy system in FIG. 5 .
  • FIG. 7 is a cross-sectional view of the sheath core in FIG. 6 along line VII-VII.
  • FIG. 8 is a schematic structural diagram of the stoma component of the atrial septal stoma system in FIG. 5 .
  • the end of the instrument close to the operator is usually called the proximal end (ie, the operation end), and the end of the instrument away from the operator is called the distal end (ie, the insertion end).
  • the distal end refers to the end of the instrument that can be freely inserted into the animal or human body.
  • the proximal end refers to the end that is operated by a user or machine or used to connect other devices.
  • the atrial septostomy system 1000 includes an atrial septostomy device 100 , a sheath 200 and a control handle 300 .
  • the control handle 300 is externally connected with an ablation energy source.
  • the control handle 300 is used to control the atrial septostomy device 100 to be movably accommodated in the sheath tube 200 or extended out of the sheath tube 200 .
  • the atrial septostomy device 100 includes a stoma member 10 and a sheath core 20 inserted into the stoma member 10 , and the stoma member 10 includes a stoma portion 11 .
  • the distal end of the sheath core 20 is provided with a first ablation member 21 that is electrically connected to the ablation power source.
  • the first ablation member 21 is used to ablate and puncture the atrial septal tissue, so that the stoma 11 can be inserted through the puncture site of the atrial septal tissue and expand to stretch the atrial septal tissue.
  • FIG. 1 is only an example of the atrial septostomy system 1000, and does not constitute a limitation to the atrial septostomy system 1000, and the atrial septostomy device 100 and the atrial septostomy system 1000 It may include more or less components than those shown in FIG. 1, or some components may be combined, or different components.
  • the atrial septostomy device 100 may also include a measuring device for measuring the diameter of the stoma, and the like.
  • the mouth system 1000 may also include a pusher or the like.
  • a developing member is provided on or near the first ablation member, which facilitates positioning the first ablation member to the atrial septal tissue, so as to accurately ablate and puncture the atrial septal tissue.
  • the developing member includes, but is not limited to, a developing ring, a developing point, a developing wire and some other radiopaque developing methods.
  • the developing material may include, but is not limited to: pyri-iridium alloy, tantalum, gold, and the like.
  • the developing member may be fixed on the first ablation member or a position on the sheath core adjacent to the first ablation member by fixing means such as heat fusion, bonding, pressing, or the like.
  • the ablation energy sources may include, but are not limited to, radio frequency energy, pulse energy, laser energy, ultrasonic energy, microwave energy, freezing energy, thermosphere and other energy sources with ablation effects.
  • the ablation energy source is radio frequency energy
  • the first ablation element is a radio frequency electrode.
  • the atrial septostomy device 100 further includes a catheter 40 sheathed outside the sheath core 20 .
  • the stoma member 10 is fixedly positioned at the distal end of the catheter 40 .
  • the sheath core 20 is movably received in the lumen of the catheter 40 , so that the sheath core 20 can extend out of the catheter 40 and be exposed at the distal end of the stoma member 10 .
  • the maximum axial length of the distal end of the sheath core 20 exposed to the catheter 40 is 50-60 mm.
  • the catheter 40 is movably accommodated in the lumen of the sheath tube 200 , so that the stoma member 10 can extend out of the distal end of the sheath tube 200 .
  • the delivery of the stoma member 10 and the sheath core 20 to the tissue to be punctured through the sheath tube 200 is not only convenient for transportation, but also avoids the problem that the stoma member 10 and the sheath core 20 cause damage to other tissues.
  • the stoma member 10 is contracted so that the radially outer diameter of the stoma member 10 is smaller than the inner diameter of the sheath tube 200 to be accommodated in the sheath tube 200 .
  • FIG. 2 is a cross-sectional view of a partial structure of the sheath core 20 of the atrial septostomy device 100
  • FIG. 3 is a radial cross-sectional view of the sheath core.
  • the distal end of the first ablation member 21 forms a closed flexible tip.
  • the flexible tip means that the material of the distal end of the first ablation member 21 can be a flexible and bendable material, and the flexible tip is configured as a smooth transition structure 210, so as to avoid
  • the first ablation member 21 scratches the non-puncture site of the operator or the patient during the puncture operation.
  • the first ablation member 21 is made of metal material.
  • the metal material includes, but is not limited to, at least one of gold, platinum, and platinum-iridium alloys.
  • the first ablation member 21 is electrically connected to the ablation power source through the first wire 22, so as to perform ablation and puncture on the atrial septal tissue.
  • the sheath core 20 has a first wire channel 201 for receiving the first wire 22 in the axial direction.
  • the distal end of the first wire 22 is connected to the first ablation member 21, and the proximal end of the first wire 22 is connected to the ablation power source.
  • the first ablation member 21 is provided with at least one irrigation port 23 .
  • the sheath core 20 is provided with a perfusion channel 203 communicating with at least one perfusion port 23 .
  • the perfusion channel 203 is used to deliver perfusate.
  • the perfusate can be, but is not limited to, fluids such as physiological saline, contrast agents, or pharmaceuticals. When the perfusate is a contrast agent, the position of the first ablation member 21 can be quickly and accurately located, thereby improving the safety of the puncture operation.
  • the perfusate is a medicament, such as heparin
  • the perfusate also has a cooling function.
  • the perfusate can be used to cool the first ablation member 21, thereby avoiding the discomfort of the patient during the puncture operation.
  • the first ablation member 21 is provided with a plurality of irrigation ports 23, and the plurality of irrigation ports are evenly spaced on the first ablation member 21 to achieve rapid cooling or cooling of the first ablation member 21. positioning use.
  • the perfusion channel 203 is provided in isolation from the first lead channel 201 , so as to prevent the liquid in the perfusion channel 203 from damaging or affecting the performance of the first lead 22 .
  • the perfusion channel 203 is arranged at the position of the central axis P1 of the sheath core 20, so that the perfusion liquid can be uniformly discharged from the at least one perfusion port 23, and the connection between the first ablation member 21 and the sheath core 20 is improved. stability.
  • the first lead channel 201 is radially disposed close to the outer peripheral surface of the sheath core 20, that is, the first lead channel 201 is deviated from the central axis P1 of the sheath core 20, which simplifies the processing technology of the first ablation member 21 and the sheath core 20 and facilitates the first ablation The connection between the piece 21 and the first wire 22. It should be noted that, the perfusion channel 203 and the first wire channel 201 may also be disposed at other positions of the sheath core 20, which are not specifically limited in the present invention. In some embodiments, the atrial septostomy device 100 also includes at least one temperature sensor 50 .
  • the temperature sensor 50 can be disposed on the first ablation member 21; or, can also be disposed near the first ablation member 21, to detect the temperature of the atrial septal tissue during the ablation and puncture, so as to prevent the temperature from being too low or too high . If the temperature detected by the temperature sensor 50 is too low, the output power of the ablation power source can be controlled to be increased; The first ablation member 21 can be heated; alternatively, the first ablation member 21 can be cooled by the perfusion fluid, so as to avoid charring and thrombosis of the ablated tissue in the heart. In this embodiment, the temperature sensor 50 is disposed at the junction of the first ablation member 21 and the sheath core 20 .
  • the temperature sensor 50 is disposed on the outer peripheral wall of the sheath core 20 adjacent to the first ablation member 21 so as to be closer to the atrial septal tissue during puncture, thereby improving the accuracy of the detection result of the temperature sensor 50 .
  • at least one temperature sensor 50 is disposed on the first ablation member 21 .
  • the temperature sensor 50 is arranged in isolation from the perfusion channel 203, so that the accuracy of the detection result of the temperature sensor 50 can be further improved.
  • the sheath core 20 is movably inserted into the stoma member 10 .
  • the sheath core 20 can extend out of the stoma member 10, so that the first ablation member 21 is exposed outside the stoma member 10, Therefore, the puncture of the atrial septal tissue by the first ablation member 21 is more accurate and rapid, and the problem of damage to the surrounding tissue of the atrial septal tissue caused by the stoma member 10 when the first ablation member 21 is used to ablate and puncture the atrial septal tissue is avoided. Thus, the safety of the puncture operation is improved.
  • the sheath core 20 can be retracted into the stoma member 10, so that the first ablation member 21 is embedded in the stoma member 10, thereby avoiding the first ablation member 21 Affects the stoma member 10 to expand the stoma to the atrial septal tissue to the desired stoma diameter.
  • the shape of the stoma member 10 may include, but is not limited to, various applicable shapes such as approximately spherical shape, ball table shape, cage shape, straight cylindrical shape, disc shape, cone shape, etc., which are not limited herein.
  • the stoma member 10 is a radially contractible and expandable elastic stent or balloon.
  • the stoma member 10 is a nickel alloy stent.
  • the stoma member 10 can be cut from a nickel alloy tube or woven from a nickel alloy wire.
  • the stoma member 10 has a mesh structure, and the density of the mesh structure is set as required.
  • the stoma member 10 is formed by continuously arranging a circle of diamond-shaped structural units in the circumferential direction.
  • the diameter can be contracted to a smaller state for delivery in the sheath 200; when released in the heart, it can be automatically expanded to the desired shape and size, and can be applied to the tissue in contact therewith Produce a certain radial support.
  • the stoma member may also be other radially expandable and contractible structures such as balls.
  • the main function of the stoma 11 is to expand the atrial septum by radial expansion.
  • the stoma portion 11 is provided on the stoma member 10 .
  • the stoma portion 11 may be arranged at the distal end of the stoma member 10 ; or, may be arranged at the middle portion of the stoma member 10 .
  • the stoma portion 11 is arranged along the circumferential direction of the stoma member 10, so as to spread the interatrial septum tissue evenly.
  • the stoma member 10 includes the stoma portion 11 and a body portion 13 connected to the proximal end of the stoma portion 11 in the axial direction.
  • the stoma 11 can be, but is not limited to, a wave-shaped stent segment, a mesh-shaped stent segment, a rod-shaped stent segment, or a tubular structure, a cylindrical structure, or a ring-shaped structure formed by their combination.
  • the maximum diameter of the main body portion 13 is larger than the maximum diameter of the stoma portion 11 .
  • the stoma portion 11 is connected to the distal end of the body portion 13 .
  • the stoma portion 11 is a cylindrical structure formed by a rod-shaped stent segment.
  • the stoma 11 is formed by cross-connecting a plurality of struts, and its shape is a cylindrical structure or an elliptical cylindrical structure. Consistent with the stoma member 10, the stoma portion 11 also needs to be radially contracted, so as to be retracted into the sheath tube 200 during transportation.
  • the shape of the stoma 11 may be various, for example, the stoma 11 may be a concave side wall or/and an outer curved surface, a cylindrical shape, an elliptical cylindrical shape, or a combination thereof.
  • the curved shape is to form a curved surface structure in the circumferential direction, and the positions of the convex and concave can be set according to the needs.
  • the stoma portion 11 adopts a cylindrical structure, and smoothly transitions with the body portion 13 to form an integral cylindrical structure.
  • the axial length of the stoma 11 is set according to actual needs, and generally matches the thickness of the atrial septal tissue.
  • the stoma 11 and the first ablation member 21 are insulated and isolated to avoid damage during ablation and puncture other tissue problems, thereby improving the safety of the use of the atrial septostomy device 100 .
  • the outer surface of the stoma portion 11 is provided with a conductive portion 111 electrically connected to the ablation power source along the circumferential direction.
  • the conductive portion 111 is used to ablate the atrial septal tissue after the stoma portion 11 is inserted into the puncture site of the atrial septal tissue.
  • the conductive portion 111 may be a metal electrode attached to the outer surface of the stoma portion 11 .
  • An insulator is provided between the conductive portion 111 and the stoma portion 11 to prevent electrical conduction between the two, or the stoma portion 11 where the conductive portion 111 is attached is at least surface-insulated. Both methods can be used.
  • Insulators can be in various ways, such as insulating gaskets, insulating coatings, and insulating sleeves.
  • the surface of the nickel-titanium alloy stent of the interatrial septostomy device 100 is entirely plated with an insulating coating of PI to form an insulator, which is insulated from the conductive portion 111 .
  • the conductive portion 111 may also be a bare conductive metal piece.
  • the conductive metal piece may be additionally provided in the stoma 11 , or may be a part of the stoma 11 or both are integrally formed.
  • An additional arrangement is that a conductive part 111 made of metal is embedded or pasted on the stoma part 11 .
  • the method of using a part of the stoma 11 is to directly utilize the conductive properties of the metal material of the stoma 11 .
  • the conductive part 111 is made of a bare conductive metal piece means that the conductive part 111 is directly made of metal, and the shape of the conductive part 111 can be an independent sheet shape, a network shape, a rod shape, etc. according to the shape of the stoma part 11. A plurality of them are provided at intervals around the stoma portion 11 .
  • the conductive portion 111 may also be a conductive portion 111 in which a continuous or discontinuous annular structure is provided around the stoma 11 in one circle.
  • the annular structure of one circle is a structure that can be contracted toward the center or a structure that can be bent softly, so that the sheath tube 200 can be easily received. Since the conductive portion 111 is electrically connected to the ablation power source, the conductive portion 111 can be used to ablate part of the tissue in contact with the stoma portion 11 . The conductive portion 111 of the stoma portion 11 conducts electricity only in the corresponding stoma tissue, and cannot affect other parts of the heart.
  • an insulating member is provided between the conductive portion 111 and the stoma portion 11 to prevent electrical conduction between them, or the other stoma portion 11 and the stoma member 10 other than the conductive portion 111 are required to be at least in contact with blood. External surface insulation.
  • the structure in which the stoma portion 11 is located in the middle of the cylindrical structure is directly used as the conductive portion 111 .
  • the conductive portion 111 is provided with at least one first developing positioning member 113 .
  • the conductive part 111 defines at least one control hole 1101 . The developing material is filled in the control hole 1101 to form the first developing positioning member 113 .
  • the developing material is, for example, but not limited to, a precious metal material such as gold, platinum, or tantalum.
  • the first developing positioning member 113 is a gold developing positioning member.
  • the filling method of the developing material can be inlaying, welding, bonding, etc. by mechanical deformation.
  • the first imaging positioning member 113 is used to display the position of the conductive portion 111 during the operation, so that the operator can determine the position of the conductive portion 111 and accurately place the conductive portion 111 at the atrial septal stoma.
  • the conductive portion 111 is electrically connected to the temperature sensor.
  • the temperature sensor is adjacent to the conductive portion 111 and is in contact with the interatrial septum tissue to detect the temperature of the conductive portion 111 .
  • the temperature sensor is also electrically connected to the ablation power source.
  • the temperature sensor may be disposed on the conductive portion 111 of the stoma 11 ; or may be disposed near the conductive portion 111 .
  • the stoma member 100 further includes a positioning portion 12 located at the distal end of the stoma portion 11 . In the fully expanded state of the stoma member 100 , the maximum diameter of the positioning portion 12 is larger than the maximum diameter of the stoma portion 11 .
  • the positioning portion 12 When the stoma portion 11 is pierced at the puncture site of the atrial septum, the positioning portion 12 abuts against the left atrial tissue surface of the atrial septal tissue, the body portion 13 abuts against the right atrial tissue surface of the atrial septal tissue, and the positioning portion 12 and the body portion 13 The atrial septum tissue is sandwiched therebetween, so that the stoma 11 can be accurately positioned at the puncture site of the atrial septal tissue.
  • the positioning portion 12 includes a plurality of V-shaped struts, and the plurality of struts are connected and arranged in a circle along the circumferential direction. The opening of the V-shaped strut faces the stoma 11 .
  • the radial diameter of the positioning portion 12 gradually increases from the end connected to the stoma portion 11 in the direction toward the distal end, thereby forming a flared shape.
  • the opposing surfaces of the positioning portion 12 and the body portion 13 respectively form positioning surfaces.
  • the positioning surface of the positioning portion 12 may be configured as a conical surface structure or a planar structure, and the positioning surface of the body portion 13 may also be configured as a tapered surface structure or a planar structure.
  • the positioning surfaces of the positioning portion 12 and the body portion 13 are both configured as a conical surface structure, for example, in the shape of a conical surface flange.
  • both the positioning portion and the positioning surface of the body portion are configured as a plane structure, for example, in the shape of a plane flange.
  • one of the positioning surfaces of the positioning portion 12 and the positioning surface of the body portion 13 may be configured as a conical surface structure, and the other may be configured as a planar structure.
  • the tapered structure may be in the shape of a tapered flange, and the flat structure may be in the shape of a flat flange.
  • one side of the positioning surface of the body portion 13 also includes a plurality of V-shaped struts, and the plurality of V-shaped struts are also connected in a circumferential direction and arranged in a circle.
  • the opening of the V-shaped strut of the body portion 13 also faces the stoma portion 11 and is symmetrically arranged with the V-shaped strut of the positioning portion 12 .
  • the radial diameter of the positioning surface of the body portion 13 gradually increases in the proximal direction from the connection with the stoma portion 11 .
  • the stoma member 10 further includes a retrieval portion 14 connected to the proximal end of the body portion 13 .
  • the recovery part 14 has a substantially conical shape.
  • the recovery part 14 is provided with a connector for connecting the catheter 40 to connect the stoma member 10 with the catheter 40 .
  • the connection manner of the stoma member 10 and the catheter 40 includes, but is not limited to, screw connection, bonding, welding, crimping or snap connection, and the like.
  • the stoma member 10 is connected with the catheter 40 through a connector, which not only facilitates processing and molding, but also improves the reliability of the connection between the stoma member 10 and the catheter 40 .
  • the proximal end of the recovery portion 14 is contracted to form a recovery port 15 , and a connector is disposed in the recovery port 15 for connecting the catheter 40 .
  • the connector can be in a variety of forms depending on how it is recycled.
  • the connecting member is a nut 151 with an inner thread 152 disposed in the recovery port 15, and is matched with the outer thread of the conduit to form a threaded connection.
  • the stoma member 10 further includes an adjustment mechanism 30 for adjusting the radial dimension of the stoma portion 11 .
  • the adjustment mechanism 30 may have various implementations, and the present invention is applicable to any structure that realizes radial restraint. Since the stoma member 10 needs to be placed in the sheath tube 200 for delivery, the addition of the adjusting mechanism 30 is beneficial to realize the radial contraction of the stoma member 10 .
  • the adjustment mechanism 30 may adopt a soft structure or a telescopic structure.
  • the soft structure can be a control wire.
  • the adjustment mechanism 30 includes at least two control wires 31 , and the two ends of the control wires 31 respectively pass through different positions in the circumferential direction of the stoma portion 11 and converge into a bundle at the center of the stoma portion 11 .
  • the adjustment mechanism 30 includes four control wires 31 of equal length, and the two ends of each control wire 31 pass through two adjacent control holes 1101 from the outside to the inside from the stoma 11 . There are two thread ends going through. All the thread ends meet at the central axis of the stoma 11 and are joined by knotting and form the connecting ring 32 .
  • the adjustment mechanism includes a control wire; the control wire simultaneously passes through different positions on the circumference of the stoma and is fixed at both ends to limit the radial size of the stoma.
  • the wire ends at both ends can be placed in the stoma.
  • the central axes of the parts 11 converge and form a confluence by knotting and form a connecting ring 32; or one end is fixed to the stoma member 10, and the other end is connected to the control end.
  • the adjustment mechanism includes at least one control wire; the control wire passes through different positions in the circumferential direction of the stoma, and one end of each control wire is fixed to the stoma or is connected to the atrial septal tissue stoma device for delivery At the distal end of the system, the other end of the control wire is connected to a control mechanism for controlling the implantation of the atrial septal tissue stoma device, so as to control the radial size of the stoma.
  • the adjustment mechanism includes at least one control wire; the control wire passes through different positions in the circumferential direction of the stoma, at least one of the two ends of each control wire is passed through the delivery system, and is manually operated to Controls the radial dimension of the stoma.
  • the adjustment mechanism adopts a telescopic structure, it can be an elastic coil, a coil spring, etc., and the radial adjustment of the stoma 11 is realized by adjusting the length or diameter of the elastic coil and the coil spring. As shown in FIG. 1 and FIG. 4 , when the interatrial septostomy device 100 is completely released, the stoma portion 11 is a curved surface of revolution with a concave generatrix.
  • a conductive portion 111 is provided on the stoma portion 11 .
  • Four control holes 1101 are uniformly arranged on the circumference of the smallest diameter of the stoma 11 .
  • the stoma component 10, the sheath core 20, the sheath tube 200 and the control handle 300 constitute a complete system.
  • the operation method of the atrial septostomy system 1000 in this embodiment is as follows .
  • the atrial septostomy device 100 is sent to the right atrium through the sheath tube 200, and the first ablation member 21 is exposed from the sheath tube 200.
  • the first lead 22 of the first ablation element 21 is connected to the ablation power source, the ablation power source is turned on, and parameters (such as power 30W, duration 120S) are set, and then the first ablation element 21 is used to ablate and puncture the atrial septal tissue.
  • the atrial septal tissue is detected by the first ablation element temperature sensor 50, and when the temperature is too low or too high, the power of the ablation power source should be adjusted or the heating should be stopped.
  • the sheath tube 200 is continuously transported forward until the front end of the sheath tube 200 is located in the left atrium, and the first imaging positioning member 113 at the control hole 1101 is located at the atrial septal tissue.
  • the diameter of the stoma portion 11 of the stoma member 10 is the smallest. Since the atrial septal tissue may be torn by the one-time expansion in place, it is necessary to control the diameter of the stoma part 11 of the stoma member 10 by using the control handle 300 to perform multiple expansions until the preset stoma diameter is reached (For example, the preset stoma diameter range is 2mm-14mm). At this time, the stoma 11 spreads the atrial septal tissue located at the stoma.
  • the stoma component 10 is cooled by heat or by adjusting the power of the ablation power supply and flushing with irrigating fluid.
  • the instrument can be recovered to the sheath tube 200 and removed from the body along with the sheath tube 200, and it is measured whether the diameter of the stoma reaches the expectation. If the stoma diameter is not as expected, repeat the above steps 2-6 to perform the stoma again until the desired stoma diameter is reached.
  • the ablation energy source received by the first ablation piece can be used to perform ablation on the atrial septal tissue.
  • Ablation puncture eliminates the need to cut the atrial septum tissue, thereby avoiding the problem of damage caused by mechanical puncture, facilitating the puncture operation, and ensuring that the atrial septal tissue stoma is not easily retracted or closed.
  • the problems of thrombosis caused by leaving the device or the embolism caused by the device falling off are avoided, thereby improving the atrial septal stoma device and its system. safety of use. Please refer to FIG. 1 and FIG. 5 to FIG. 8 together.
  • FIG. 1 and FIG. 5 to FIG. 8 Please refer to FIG. 1 and FIG. 5 to FIG. 8 together.
  • FIG. 5 is a schematic structural diagram of an interatrial septostomy system 1000a according to a second embodiment of the present invention.
  • the structure of the atrial septostomy system 1000a of the second embodiment is similar to that of the atrial septostomy system 1000 of the first embodiment.
  • the second embodiment is different from the first embodiment in that the atrial septostomy device 100a is different.
  • the atrial septostomy device 100a in the second embodiment is similar to the atrial septostomy device 100 in the first embodiment, the difference is that the atrial septostomy device 100a in the second embodiment further includes a sheath core 20a fixed at least one second ablation member 25 on the upper part.
  • the second ablation member 25 is disposed on the outer peripheral surface of the sheath core 20a and is located at the proximal end of the first ablation member 21 .
  • the fixed connection manner of the second ablation member 25 and the jug core 20a includes, but is not limited to, welding, bonding, snap connection, and the like.
  • the second ablation member 25 is used to ablate the atrial septal tissue again after the stoma member 10a makes the atrial septal tissue stoma, so as to further ensure that the atrial septal tissue stoma is not easily retracted or closed.
  • the second ablation member 25 can also be used to ablate the puncture site again after the first ablation member 21 ablates the puncture, so as to further ensure that the stoma of the atrial septum is not easily retracted or closed.
  • the second ablation member 25 and the first ablation member 21 are provided in isolation from each other.
  • the first ablation member 21 and the second ablation member 25 work staggered, that is, when the first ablation member 21 performs ablation of the atrial septum tissue, the second ablation member 25 stops performing ablation of the atrial septal tissue;
  • the ablation element 25 performs ablation of the atrial septal tissue
  • the first ablation The ablation element 21 stops performing ablation of the atrial septal tissue, so that the problem of damage caused by the second ablation element 25 or the first ablation element 21 ablating and puncturing other tissues other than the atrial septal stoma can be avoided.
  • the second ablation member 25 is made of a metal material, and the metal material includes at least one of gold, platinum, and uranium-iridium alloy.
  • at least one second ablation member 25 is provided with a second imaging positioning member 27, which facilitates positioning the second ablation member 25 to the atrial septal stoma, so as to more accurately ablate the atrial septal tissue.
  • the second ablation member 25 includes, but is not limited to, an annular electrode or an electrode pad.
  • the second developing positioning member 27 includes, but is not limited to, a developing ring, a developing point, a developing wire and some other radiopaque developing methods.
  • the developing material may include but is not limited to: uranium-iridium alloy, tantalum, gold.
  • the fixing method can be: hot-melting, bonding, pressing, etc.
  • the second ablation member 25 is an annular electrode
  • the second developing positioning member 27 is a developing ring.
  • the two developing rings are respectively arranged at the proximal end and the distal end of the annular electrode, so that a larger viewing angle can be provided in the circumferential direction of the annular electrode to quickly and accurately position the annular electrode The position of the electrode, thereby improving the safety of the puncture operation.
  • the fact that the developing ring is disposed at the proximal end and the distal end of the annular electrode can also facilitate the rapid installation of the developing ring on the annular electrode, and improve the stability of the connection between the annular electrode and the developing ring.
  • the developing ring may be provided, and the developing ring may be disposed at the proximal end or the distal end of the annular electrode; or, other positions of the annular electrode are not specifically limited in the present invention.
  • the number of the second ablation members 25 is one. In some embodiments, the number of the second ablation members is multiple, and the plurality of second ablation members are arranged in isolation from each other. A plurality of second ablation elements may work at the same time, or a preset number of second ablation elements may be selected to work at the same time according to actual needs.
  • the quantity of the at least one second ablation member 25 is set according to the structure of the stoma tissue, which is not specifically limited in the present invention.
  • the second ablation member 25 and the second developing positioning member 27 are embedded on the core 20a.
  • the second ablation member 25 and the second development positioning member 27 are sleeved on the sheath core 20a, thereby facilitating assembly and ensuring the connection stability of the second ablation member 25 and the second development positioning member 27 and the sheath core 20a. and reliability.
  • the outer peripheral wall of the sheath core 20a defines a receiving groove 2010 along the circumferential direction for receiving the second ablation member 25 and the second developing positioning member 27.
  • the second ablating member 25 and the second developing positioning member 27 are embedded in the receiving groove 2010, and the first The two ablation members 25 are axially adjacent to the second developing positioning member 27 .
  • the outer peripheral walls of the second ablation member 25 and the second developing positioning member 27 are spliced at the same height with the outer peripheral wall of the sheath core 20a to form a continuous and smooth outer surface, thereby forming a continuous and smooth outer surface.
  • the smoothness of the sheath core 20a during assembly and surgical delivery is improved, and the problem of tissue damage caused by the irregular outer wall is avoided.
  • the first ablation member 21 is electrically connected to the ablation power source through the first wire 22 .
  • At least one second ablation element 25 is electrically connected to the ablation power source through a second wire 24, and the first wire 22 and the second wire 24 are insulated and isolated.
  • the sheath core 20 is provided with a first wire channel 201 and a second wire channel 202 along the axial direction, and the first wire channel 201 and the second wire channel 202 are arranged at intervals in the radial direction.
  • the first wire 22 is accommodated in the first wire channel 201
  • the second wire 24 is accommodated in the second wire channel 202 .
  • the first wire and the second wire may also be accommodated in the same wire channel to simplify the processing of the sheath core.
  • the first wire channel 201 and the second wire channel 202 are arranged in a symmetrical manner with respect to the central axis P1 of the sheath core 20, thereby simplifying the manufacturing process.
  • the receiving groove 2010 is arranged in isolation from the first wire channel 201 and the second wire channel 202 .
  • the sheath core 20 defines a through hole that communicates with the second wire channel 202 and the receiving groove 2010 at a position corresponding to the second ablation member 25 , and the second wire 24 passes through the through hole and is electrically connected to the second ablation member 25 . In this way, it is avoided that the second ablation member 25 is electrically connected with the first wire 22 to affect the working performance of the first ablation member 21 .
  • the atrial septostomy device 100a also includes at least one temperature sensor 50 .
  • the temperature sensor 50 is disposed at or near the position of at least one of the stoma 11 , the first ablation member 21 , and the second ablation member 25 . In this way, during the puncture process, when the temperature detected by the temperature sensor 50 is too high, the first ablation member 21 and/or the second ablation member 25 can be cooled by the perfusion fluid, so as to avoid the discomfort of the patient during the puncture operation. ; When the temperature detected by the temperature sensor 50 is too low, control to increase the output power of the ablation power source.
  • an adjustable bendable structure 26 is disposed within the sheath core 20 .
  • the adjustable bendable structure 26 is used to adjust the curvature of the sheath core 20, so that the puncture and ablation can be realized more accurately, and the safety of the operation is improved.
  • the bendable structure 26 may be brushed.
  • the sheath core 20 is provided with a drawing channel 204 along the axial direction for receiving the drawing wire.
  • the distal end of the sheath core 20 is provided with an adjustable bending section 2012 .
  • the adjustable bendable segment 2012 is located at the proximal end of the second ablation member 25 .
  • the distal end of the adjustable bendable structure 26 is fixed on the first ablation member 21 , the second ablation member 25 or the adjustable bendable segment 2012 , and the proximal end of the adjustable bendable structure 26 is fixed on the control handle 300 .
  • the proximal end of the adjustable bendable structure 26 is controlled by the control handle 300 to adjust the bending state of the adjustable bendable structure 26 or restore the straight state. Since the structure of the sheath core 20 is flexible, the first ablation member 21 and the second ablation member 21 can be more accurately realized.
  • the ablation of the ablation element 25 ensures the smooth completion of the operation.
  • the wire drawing is used to pull the adjustable section 2012 to bend or restore straightness, and has a certain strength.
  • the wire drawing is a single-strand structure, and a multi-strand structure may also be used.
  • the cross-sectional shape of the wire drawing can be various shapes such as a circle, which is not specifically limited here.
  • the radial section should be as small as possible.
  • the wire drawing is a metal wire, that is, the wire drawing is made of a metal material.
  • the metal material is, for example, but not limited to stainless steel, tungsten alloy, cobalt-chromium alloy, or nickel-titanium alloy, etc., and can also be made of a polymer with a certain strength, and its material is not specifically limited here.
  • the adjustable bending structure 26 is preferably a stainless steel wire.
  • the wire drawing channel 204 is isolated from the first wire channel 201, the second wire channel 202 and the perfusion channel 203, so as to prevent wire drawing from interfering with the normal operation of the first wire 22 and the second wire 24, and ensure the first wire 22 and the first ablation.
  • the connection between the element 21 and the second wire 24 and the second ablation element 25 is stable and reliable.
  • the stoma member 10a in the second embodiment is similar to the stoma member 10 (see Figure 4) in the first embodiment. The difference is that the conductive portion may not be provided on the stoma portion 11 of the stoma member 10a.
  • the atrial septal tissue is stomated through the stoma member 10a, and then the first ablation member 21 and/or the second ablation member 25 is used to puncture the tissue at the atrial septal stoma. Ablation is performed to further ensure that the atrial septal stoma is not retracted or closed.
  • the stoma member 10 in the first embodiment is applicable to the interatrial septostomy device 100a in the second embodiment.
  • the stoma member 10a, The sheath core 20a, the sheath tube 200 and the control handle 300 are constructed as a complete system.
  • the operation method of the atrial septostomy system 1000a in this embodiment is as follows.
  • the atrial septostomy device 100a is sent to the right atrium through the sheath tube 200, and the first ablation member 21 is exposed from the sheath tube 200. Connect the first lead 22 of the first ablation piece 21 to the ablation power supply, turn on the ablation power supply and set parameters (eg, power 30W, duration 120s), and then use the first ablation piece 21 to ablate and puncture the atrial septal tissue.
  • the atrial septal tissue is detected by the temperature sensor 50 at the first ablation element 21, and when the temperature is too low or too high, the power of the ablation power source should be adjusted or the heating should be stopped.
  • the sheath tube 200 is continuously transported forward until the front end of the sheath tube 200 is located in the left atrium, and the first imaging positioning member at the control hole 1101 is located at the atrial septal tissue.
  • the diameter of the stoma portion 11 of the stoma member 10 is the smallest. Since the atrial septal tissue may be torn by the one-time expansion in place, it is necessary to control the diameter of the stoma part 11 of the stoma member 10 by using the control handle 300 to perform multiple expansions until the preset stoma diameter is reached (For example, the preset stoma diameter range is 2mm-14mm). At this time, the stoma 11 stretches the atrial septal tissue located at the stoma.
  • the sheath tube 200 is slightly withdrawn to a preset position, and the second ablation member 25 is positioned at the atrial septostomy by the imaging positioning member 27 located on the second ablation member 25.
  • the second lead 24 of the second ablation piece 25 to the ablation power supply, turn on the ablation power supply and set parameters (eg power 30W, duration 120S), and then use the second ablation piece 25 to ablate the tissue at the atrial septal stoma ablation.
  • the adjustable bending structure 26 can also be manipulated by operating the control handle, so that the second ablation member 25 can ablate the atrial septal tissue more flexibly. It can be understood that the first ablation member 21 can also be used to ablate the atrial septal tissue again.
  • the adjustable structure 26 can be manipulated by operating the control handle, so that the first ablation member 21 can be more flexible and comprehensive on the atrial septum. tissue for ablation. Finally, the temperature of the atrial septal tissue is detected by the temperature sensor. When the detected temperature is too high, the power of the ablation power supply should be adjusted or the heating should be stopped and the ostomy member should be lowered by flushing with perfusion fluid 10/jm.o
  • the instrument can be recovered to the sheath tube 200 and removed from the body, and the diameter of the stoma can be measured to determine whether it reaches the expectation. If the stoma diameter is not as expected, repeat the above steps 2-6 to perform the stoma again until the desired stoma diameter is reached.
  • the ablation energy source received by the first ablation piece can be used to perform ablation on the atrial septal tissue.
  • Ablation puncture eliminates the need to cut the atrial septum tissue, thereby avoiding the problem of damage caused by mechanical puncture, facilitating the puncture operation, and ensuring that the atrial septal tissue stoma is not easily retracted or closed.
  • the stoma component and sheath core can be withdrawn from the atrial septal tissue, it is The problem of embolism caused by thrombosis or device falling off, thereby improving the safety of using the atrial septostomy device and its system.
  • the distal end of the sheath core is also provided with at least one second ablation piece, so that after the stoma component makes an incision on the atrial septum tissue, the at least one second ablation piece can ablate the atrial septum tissue again , thereby further avoiding the recovery or closure of the assembly at the septostomy.
  • the bendable segment is disposed at the proximal end of the first ablation member 21 .

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Abstract

Un dispositif de création de stomie et un système de création de stomie sont divulgués. Le dispositif (100, 100a) de création de stomie comprend un élément (10, 10a) de création de stomie extensible et une partie centrale de gaine (20) disposée sur l'élément (10, 10a) de création de stomie. L'élément (10, 10a) de création de stomie comprend une partie (11) de création de stomie, et l'extrémité distale de la partie centrale de gaine (20) est pourvue d'une première pièce d'ablation (21) électriquement connectée à une alimentation électrique d'ablation, la première pièce d'ablation (21) étant utilisée pour l'ablation d'un tissu, pour permettre à la partie (11) de création de stomie de pénétrer à travers une position de perforation d'un tissu et de s'étendre de façon à pousser le tissu en l'ouvrant.
PCT/IB2021/061139 2020-11-30 2021-11-30 Dispositif de création de stomie et système de création de stomie WO2022113054A1 (fr)

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CN112603524B (zh) * 2020-11-30 2023-02-24 杭州诺生医疗科技有限公司 房间隔组织造口装置及房间隔组织造口系统
CN114176720B (zh) * 2021-12-21 2024-07-02 上海申淇医疗科技有限公司 一种房间隔造口装置

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