[go: up one dir, main page]

WO2022022528A1 - Dispositif de septostomie auriculaire - Google Patents

Dispositif de septostomie auriculaire Download PDF

Info

Publication number
WO2022022528A1
WO2022022528A1 PCT/CN2021/108733 CN2021108733W WO2022022528A1 WO 2022022528 A1 WO2022022528 A1 WO 2022022528A1 CN 2021108733 W CN2021108733 W CN 2021108733W WO 2022022528 A1 WO2022022528 A1 WO 2022022528A1
Authority
WO
WIPO (PCT)
Prior art keywords
diameter
waist
circumferential
adjusting
support frame
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/CN2021/108733
Other languages
English (en)
Chinese (zh)
Inventor
高国庆
王丹
王永胜
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hangzhou Noya Medtech Co Ltd
Original Assignee
Hangzhou Noya Medtech Co Ltd
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 CN202010756181.6A external-priority patent/CN114052889A/zh
Priority claimed from CN202021570248.9U external-priority patent/CN212490130U/zh
Application filed by Hangzhou Noya Medtech Co Ltd filed Critical Hangzhou Noya Medtech Co Ltd
Publication of WO2022022528A1 publication Critical patent/WO2022022528A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • 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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/00267—Expandable means emitting energy, e.g. by elements carried thereon having a basket shaped structure
    • 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
    • A61B2018/00357—Endocardium
    • 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
    • A61B2018/00577—Ablation

Definitions

  • the invention relates to the technical field of medical devices, in particular to a percutaneous interventional septostomy device.
  • Atrial septostomy (also known as atrial shunt) is an effective percutaneous interventional treatment for patients with heart failure. Patients with heart failure often present with elevated left atrial pressure, which can lead to pulmonary congestion and severely compromise the patient's quality of life. Through atrial septostomy, a shunt channel is established in the atrium, so that the capacity of the right heart system can be compensated to relieve the pressure load of the left heart system (especially the left atrium), which can directly improve the patient's hemodynamic status and reduce the left atrium.
  • Mean pressure and pulmonary capillary wedge pressure have high clinical significance in improving symptoms and prognosis in patients with heart failure.
  • the existing atrial septostomy device usually uses a plurality of diameter-adjusting wires to be respectively wound on the elastic support frame of the atrial septostomy device, and the size of the interatrial septal shunt channel is adjusted by involving the plurality of diameter-adjusting wires.
  • the larger the number of diameter adjusting wires the correspondingly larger diameter of the multi-lumen tube actually accommodated by the corresponding diameter adjusting wires.
  • Such a structure is not conducive to the traveling of the multi-lumen tube in the blood vessel.
  • the arrangement of multiple diameter-adjusting wires also increases the complexity of the winding, which is likely to cause uneven tension on the elastic support due to the mutual influence of multiple diameter-adjusting wires, resulting in axis offset and diameter adjustment of the elastic support frame.
  • the shape is asymmetric, and the elastic stent is difficult to accurately contact the blood vessel wall to form treatment and other undesirable phenomena.
  • the object of the present invention is to overcome the deficiencies of the prior art, provide a kind of atrial septostomy device capable of adjusting the size of the interatrial septal shunt channel, specifically including the following technical solutions:
  • An interatrial septostomy device comprising an elastic support frame, a handle and at least one diameter adjusting wire, the waist of the elastic support frame is provided with electrodes for ablating target tissue, and the waist of the elastic support frame is along the circumferential direction
  • a plurality of threading holes are also provided, the diameter-adjusting wire is wound between the threading holes and connected to the handle, and the handle pulls the diameter-adjusting wire to change the diameter of the waist, one of which is a diameter-adjusting wire. Pass through at least three of the threading holes.
  • At least one diameter adjusting wire is connected between the handle and the elastic support frame, and forms a circumferential section, a straight section, a winding section and a traction section, and the circumferential section passes through a plurality of the threading holes and extends along the Circumferentially surrounding the waist, both ends of each of the circumferential segments are respectively connected with a straight line segment in a threading hole, and each straight segment is connected between a threading hole and the winding portion.
  • the interatrial septostomy device further comprises a multi-lumen tube connecting between the handle and the elastic support frame, the multi-lumen tube is provided with a first lumen extending in the axial direction, and the traction section passes through Placed in the first inner cavity, one end of the traction segment is connected to the straight segment through the winding portion, and the other end of the traction segment is connected to the handle.
  • the winding portion is a knot formed by the diameter-adjusting wire.
  • the traction section is a traction member made of metal material, the distal end of the traction member is provided with a wire take-up hole used as the winding portion, and the straight line section is inserted into the wire take-up hole.
  • the winding portion is arranged in the space surrounded by the elastic support frame.
  • At least one diameter adjusting wire includes a plurality of the circumferential segments covering different circumferential regions of the waist, and at least three straight line segments passing through the different threading holes.
  • both ends of each of the circumferential segments are respectively connected to one of the straight segments at the positions of the two adjacent threading holes.
  • the two circumferential segments adjacent to the waist portion in the circumferential direction both pass through the threading holes between the two circumferential segments, and the two straight line segments are located between the two circumferential segments.
  • One end of one of the circumferential segments is respectively connected to the threading holes.
  • both ends of each of the circumferential segments are respectively connected with one of the straight line segments at two spaced positions of the threading holes.
  • the at least one diameter-adjusting line surrounds the waist for more than one circumference, and at least two of the circumferential segments overlap each other.
  • the number of the at least one diameter-adjusting wire is two, and the two diameter-adjusting wires are simultaneously used to form the circular segment and the straight line segment.
  • the circumferential segments formed by the two diameter adjusting lines do not overlap each other.
  • the at least one diameter-adjusting wire includes a first diameter-adjusting wire for forming the circumferential segment, and a second diameter-adjusting wire for forming the straight segment, the second diameter-adjusting wire passing through all the The threading hole is hooked with the first diameter-adjusting wire.
  • the elastic support frame includes at least three support parts arranged around its axis, the support parts are hollow structures, and each support part is provided with at least one threading hole.
  • the threading hole is arranged at the connection between the two supporting parts of the circuit.
  • the opening of the threading hole is disposed toward its axis.
  • the handle includes a base body and a diameter-adjusting member, the diameter-adjusting member is rotatably connected with the base body, the diameter-adjusting member is also connected with the diameter-adjusting wire, and is rotated relative to the base body to pull the diameter-adjusting member
  • the diameter-adjusting wire moves along the axis of the atrial septostomy device.
  • the handle and the elastic support frame are connected through the multi-lumen tube, and are wound in the threading hole of the waist of the elastic support frame through at least one diameter-adjusting wire. Then, the diameter adjusting wire is pulled by the handle to achieve the purpose of changing the waist size of the elastic support frame. And one of the diameter-adjusting wires passes through at least three threading holes, which is conducive to reducing the number of the diameter-adjusting wires, thereby reducing the diameter of the interatrial septostomy device, and helping to simplify the winding of the diameter-adjusting wires on the elastic support frame way to improve the smoothness of pulling the diameter-adjusting wire.
  • the reduction in the number of diameter adjustment wires can make the waist of the elastic support frame weaker in mutual influence during the size adjustment process, and the force is more uniform, so as to ensure the regular shape of the shunt channel.
  • FIG. 1 is a schematic structural diagram of an embodiment of the atrial septostomy device provided by the present invention when it is in a delivery state;
  • Fig. 2 is a partial structural schematic diagram of the atrial septostomy device in Fig. 1 in a supported state;
  • Fig. 3 is the schematic diagram of the winding mode of the atrial septostomy device in the prior art
  • Fig. 4 is the partial structural schematic diagram of another embodiment of the atrial septostomy device provided by the present invention.
  • Fig. 5 is the partial structural schematic diagram of the waist position of the elastic support frame in the embodiment of Fig. 4;
  • 6-11 are schematic diagrams of different winding modes of the diameter-adjusting wire provided by various embodiments of the present invention.
  • FIG. 12 is a partial structural schematic diagram of the interatrial septostomy device provided by the present invention corresponding to the winding method shown in FIG. 11 .
  • proximal end the end of the device or component that is close to the operator
  • distal end the end away from the operator
  • This definition is only for the convenience of expression, and should not be construed as a limitation of the present invention.
  • Axial refers to the axial direction of the elastic support frame, the multi-lumen tube or the handle.
  • the atrial septostomy device 100 has a delivery state (FIG. 1) in which the heart is inserted along the blood vessel, and a support state (FIG. 2) opened after being implanted in the heart, based on the different stages in the operation.
  • FIG. 2 Only the configuration of the distal portion of the atrial septostomy device 100 in the supported state is shown.
  • the atrial septostomy device 100 of the present invention includes an elastic support frame 10 , a handle 30 and a diameter adjusting wire 40 .
  • the atrial septostomy device 100 further includes a sheath tube 101 and a multi-lumen tube 20 .
  • the sheath tube 101 is connected to the handle 30, and the sheath tube 101 is wrapped around the elastic support frame 10 and the multi-lumen tube 20 when the atrial septostomy device 100 is in the delivery state, so as to limit the outer diameters of the elastic support frame 10 and the multi-lumen tube 20, and So that the two can be input into the heart along the blood vessels.
  • the elastic support frame 10 and the multi-lumen tube 20 are transported toward the distal end of the sheath tube 101 , and the elastic support frame 10 is separated from the sheath tube 101 and exposed outside the sheath tube 101 .
  • the elastic support frame 10 is unfolded under the action of its own elasticity and is fitted and supported in the stoma of the interatrial septum.
  • the waist 12 of the elastic support frame 10 is at the stoma position and forms support for the stoma.
  • the elastic support frame 10 is in the shape of an hourglass.
  • the diameters of both ends of the elastic support frame 10 are larger than the diameter of the waist 12 , and the waist 12 is located between the two ends of the elastic support frame 10 .
  • a support structure with a larger diameter is formed, and the diameter of the waist portion 12 is relatively reduced.
  • the supporting structures with larger diameters on both sides of the waist portion 12 are convenient for positioning them in the left and right atria respectively, and the waist portion 12 is correspondingly positioned at the position of the atrial septostomy.
  • the opposite ends of the multi-lumen tube 20 along its own length direction are respectively connected with a handle 30 and an elastic support frame 10 .
  • the inside of the multi-lumen tube 20 is a hollow tubular shape, wherein the diameter-adjusting wire 40 can be one or more than one. on the support frame 10.
  • the free state after the elastic support frame 10 is unfolded is a structure extending away from the handle 30 in an umbrella shape.
  • the waist portion 12 of the elastic support frame 10 is provided with an ablation electrode (not shown in the figure) along the circumferential direction, and the ablation electrode is used to ablate the target tissue.
  • the waist 12 of the elastic support frame 10 is also provided with a plurality of threading holes 11, and the diameter-adjusting wire 40 is wound in the plurality of threading holes 11, and the diameter-adjusting wire 40 also binds the waist 12 of the elastic support frame 10, so that the closer During the process of pulling the diameter-adjusting wire 40, the diameter of the waist 12 is reduced and the elastic support frame 10 is formed to shrink as a whole, or by releasing the diameter-adjusting wire 40, the diameter of the waist 12 is increased and the elastic support frame 10 is integrally formed. Expansion, the ablation treatment is realized by the fit of the waist 12 and the atrial septostomy.
  • the other end of the diameter-adjusting wire 40 is fixedly connected to the handle 30 , and the diameter-adjusting wire 40 can be pulled by the handle 30 , so that the diameter-adjusting wire 40 can be wrapped around the waist 12 of the elastic support frame 10 to form traction. That is, the pulling or releasing of the handle 30 can drive the diameter adjusting wire 40 to pull the waist 12 of the elastic support frame 10 to shrink or expand, so as to achieve the effect of changing the diameter of the waist 12 .
  • the diameter of the waist 12 is the size of the interatrial septum shunt channel formed by the atrial septotomy device 100 of the present invention.
  • the atrial septostomy device 100 of the present invention thus realizes the active adjustment of the waist 12 of the elastic support frame 10 function of diameter.
  • a plurality of diameter adjusting wires 40a respectively pass through each threading hole 11a at the waist 12a of the elastic support frame 10a, and simultaneously extend from each threading hole 11a to penetrate into the multi-lumen tube 20a to connect the handle (not shown).
  • the diameter-adjusting wire 40 is threaded in each threading hole 11a, and the diameter-adjusting wire 40a also passes through the multi-lumen tube 20a and is connected between each threading hole 11a and the handle, at this time the diameter-adjusting wire in the multi-lumen tube 20a
  • the number of wires 40a is relatively large, and the winding complexity of the entire interatrial septostomy device 100 is relatively high.
  • a large number of diameter adjusting wires 40a will increase the diameter of the multi-lumen tube 20a, which is inconvenient for the multi-lumen tube 20a to pass through the blood vessel.
  • the interatrial septostomy device 100 provided by the present invention is wound around the threading hole 11 of the elastic support frame 10 through at least one diameter-adjusting wire 40, and one of the diameter-adjusting wires 40 passes through at least three threading holes 11, which is beneficial to reduce The number of the diameter-adjusting wires 40 is reduced, thereby reducing the diameter of the atrial septostomy device 100 .
  • the diameter of the multi-lumen tube 20 is reduced, which is beneficial to simplify the winding method of the diameter-adjusting wire 40 on the elastic support frame 10 and improve the smoothness of pulling the diameter-adjusting wire 40 .
  • the reduction in the number of the diameter-adjusting wires 40 can make the waist 12 of the elastic support frame 10 less affected by the plurality of diameter-adjusting wires 40 during the size adjustment process, and the elastic support frame 10 can be stressed more evenly, ensuring the shape of the shunt channel. rule.
  • the diameter adjustment wire 40 connected between the handle 30 and the elastic support frame 10 is used to form the circumferential section 41 , the straight section 42 , the winding section 43 and the traction section respectively in the atrial septostomy device 100 of the present invention 44.
  • the specific implementation manner and structure of the winding portion 43 and the traction section 44 are not particularly limited.
  • the circumferential segment 41 passes through the plurality of threading holes 11 and surrounds the waist portion 12 of the elastic support frame 10 in the circumferential direction. between.
  • the multi-lumen tube 20 is provided with a first lumen 21 extending in the axial direction, the traction section 44 is inserted into the first lumen 21, and one end of the traction section 44 passes through the winding portion 43 (see FIG. 2 ,
  • the winding portion 43 is shown in FIG. 4 as a wire take-up hole 431 ) connected to the straight segment 42 , and the other end of the traction segment 44 is connected to the handle 30 .
  • the pulling force of the handle 30 pulling the diameter-adjusting wire 40 can be sequentially transmitted to the circumferential section 41 for holding the waist 12 through the pulling section 44 , the winding section 43 and the straight section 42 .
  • the handle 30 changes the diameter of the circumferential segment 41 by changing the length of the straight segment 42 to achieve the purpose of adjusting the diameter of the waist 12 .
  • a diameter adjusting wire 40 is used to pass through at least three threading holes 11, and a diameter adjusting wire 40 can be connected between at least three different threading holes 11 and the multi-lumen tube 20, thereby forming at least three straight line segments 42. Because the multi-lumen tube 20 is located inside the elastic support frame 10, a diameter adjustment wire 40 can form a pull on the waist portion 12 of the elastic support frame 10 from at least three directions, and the waist portion 12 is subjected to more uniform force during the diameter adjustment process. , can be pulled inwardly from at least three different directions. In the schematic diagram of FIG.
  • the number of the threading holes 11 is five, and the number of the diameter adjusting wires 40 is one.
  • a diameter-adjusting wire 40 is wound around the five threading holes 11 to form five straight segments 42 to hold the waist 12 . It can be understood that, because the diameter adjusting wire 40 passes through the five threading holes 11 , when the diameter of the waist portion 12 is adjusted, it can provide pulling forces in five different directions to act on the waist portion 12 , so that the waist portion 12 of the elastic support frame 10 is uniform. It is subjected to force and deformed, so that the diameter of the shunt channel can be adjusted, and the shape of the shunt channel can also be guaranteed.
  • At least three threading holes 11 need to be provided at the waist 12 of the elastic support frame 10 in the circumferential direction, so that the diameter adjusting wire 40 can form a relatively uniform coverage and traction force on the waist 12 of the elastic support frame 10 .
  • at least three threading holes 11 are uniformly distributed at the waist portion 12 along the circumferential direction.
  • the diameter-adjusting thread 40 is wound between more threading holes 11 and the winding portion 43 to form more straight segments 42 to achieve better performance for the elastic support frame 10 . Holding effect.
  • the traction provided when adjusting the diameter of the waist 12 is more uniform.
  • only one diameter-adjusting wire 40 can be used to pass through different threading holes 11 successively, that is, the same diameter-adjusting wire 40 can be passed between the threading hole 11 and the multi-lumen tube 20 .
  • the wire winding of the atrial septostomy device 100 in this embodiment is simpler.
  • the diameter-adjusting wire 40 is wound around more threading holes 11, which can better hold the waist 12, and also avoids the inconsistency in the shape adjustment of the elastic support frame 10 caused by the complicated winding method and multiple diameter-adjusting wires 40 intertwined with each other. average defect.
  • the circumferential segment 41 has multiple segments, and both ends of each circumferential segment 41 are respectively connected to a straight segment 42 at the position of a threading hole 11 , and each linear segment 42 is connected to the threading hole 11 respectively. between the hole 11 and the winding portion 43 .
  • a circumferential segment 41 together with the two straight segments 42 connected to both ends of the circumferential segment 41 forms a fan shape between the winding portion 43 and the waist portion 12 .
  • the two straight segments 42 are connected to the traction segment 44 through the winding portion 43 , when the handle 30 drives the traction segment 44 to move in the axial direction, the two linear segments 42 serving as the two sides of the sector are respectively aligned with each other from both ends.
  • the connected circumferential segments 41 are pulled or released, and the tensions on both ends of the circumferential segments 41 are relatively balanced, so the retaining force exerted by the circumferential segments 41 on the waist 12 between the two threading holes 11 is also relatively balanced, which can ensure that the waist 12 is in the position of the waist 12.
  • the deformation during diameter adjustment is more regular.
  • each circumferential segment 41 since opposite ends of each circumferential segment 41 are respectively connected with a straight line segment 42 at the two threading holes 11 , it is ensured that each circumferential segment 41 can be in relatively balanced contact with it.
  • the waist 12 forms the hold.
  • the traction force formed by the movement of the traction segment 44 in the axial direction to each straight segment 42 tends to be the same, so the holding force to the waist 12 among the plurality of circumferential segments 41 also tends to be uniform.
  • the straight section 42 and the circumferential section 41 are part of the continuous diameter adjusting line 40.
  • the circumferential section 41 connected to the end of the straight section 41 can be driven to move in the axial direction of the multi-lumen tube. Synchronized displacement in the circumferential direction. Since each linear segment 42 has the same moving distance in the axial direction, the displacement distance formed by the corresponding driven circumferential segment 41 in the circumferential direction is also the same. It can also be interpreted that the inter-atrial septostomy device 100 of the present invention can ensure that the pulling force provided by the diameter-adjusting wire 40 to the elastic support frame 10 is uniform during the diameter-adjustment process, and the shape of the waist 12 is kept regular, forming a shunt channel structure with precise dimensions. .
  • the winding portion 43 can be realized by a wire knot formed by the diameter-adjusting wire 40, so as to realize the fixation of each straight segment 42 relative to the traction segment 44.
  • the diameter-adjusting wire 40 forms the winding portion 43 by means of knots
  • the plurality of straight segments 42 can be held by the knots to fix their relative positions with the traction segment 44 and move with the axial direction of the traction segment 44 Rather, the circumferential segment 41 to which it is connected is involved.
  • the outer surface of the winding portion 43 can also be coated with glue, which can strengthen the fixation of the wire knot after the glue is cured.
  • the pulling section 44 (see FIG. 2 ) is configured as a pulling member 441 made of metal material in FIG. 4 , and the distal end of the pulling member 441 in FIG. (See Fig. 2) for the wire take-up hole 431.
  • the plurality of straight segments 42 are inserted into the wire take-up hole 431 , so that the plurality of straight segments 42 are wound between the wire take-up hole 431 and the wire thread hole 11 .
  • the wire take-up hole 431 is provided on the pulling member 441 of metal material, and the straight section 42 only needs to pass through the wire take-up hole 431 to be fixed relative to the pulling member 441 .
  • the diameter-adjusting wire 40 After the diameter-adjusting wire 40 completes the winding between the wire take-up hole 431 and the plurality of wire-threading holes 11 , it can also be knotted and fixed at the wire take-up hole 11 , and glue can also be applied to the knotted position.
  • the winding portion 43 is provided in the space surrounded by the elastic support frame 10 .
  • the wrapping portion 43 and the waist portion 12 of the elastic support frame 10 are located on the same plane.
  • Such a structure can ensure the shortest distance between the winding portion 43 and each threading hole 11 provided on the waist portion 12 , thereby shortening the length of the straight section 42 , and at the same time saving labor when controlling the total length of the diameter adjusting wire 40 .
  • the number of the diameter adjusting wires 40 is not particularly limited.
  • the plurality of circumferential segments 41 covering different areas on the waist 12 may be formed by repeatedly winding one diameter adjusting wire 40 , or may be formed by winding a plurality of diameter adjusting wires 40 respectively.
  • one of the diameter-adjusting wires 40 forms at least three straight segments 42 passing through different threading holes 11 , so that one diameter-adjusting wire 40 can pull the circumferential segment 41 from three different directions when the pulling segment 44 moves in the axis. , both of which are beneficial to improve the uniformity of the force on the waist 12 .
  • FIG. 5 shows the winding method of the diameter-adjusting wire 40 in the interatrial septostomy device 100 provided in FIG. 2 and FIG. 4 , the number of the diameter-adjusting wire 40 is one, and one diameter-adjusting wire 40 is wound around the winding portion 43 and A plurality of straight segments 42 are formed between the threading holes 11 to uniformly hold the waist portion 12 of the elastic support frame 10 .
  • the opposite ends of each circumferential segment 41 formed by a diameter adjusting wire 40 are respectively connected to a straight line segment 42 at the positions of the two adjacent threading holes 11 .
  • a diameter adjusting wire 40 protrudes from the winding portion 43, it first passes through a threading hole 11, surrounds the outer wall of the waist portion 12, and passes through the adjacent threading hole 11 and then extends to Winding portion 43 . Therefore, after a diameter-adjusting wire 40 circles around the outer wall of the waist portion 12 once, the diameter-adjusting wire 40 needs to pass through each threading hole 11 twice, and between the threading hole 11 and the winding portion 43 Two straight segments 42 are formed, and finally a fixed knot is formed at the winding portion 43 .
  • the winding part 43 is defined as the starting point and the end position 0 of the diameter-adjusting wire 40, and the waist 12 of the elastic support frame 10 has 1# threading holes 11, 2# threading holes 11, 3# threading holes 11, 4# threading holes 11, 5# There are five threading holes 11 in total.
  • the starting point and the ending point of the final adjusting wire 40 are fixed at position 0 by the winding portion 43 .
  • the diameter-adjusting wire 40 forms a five-lobed "petal" shape with a similar shape on the elastic support frame 10 .
  • a "petal" in Figure 6 is represented by a dashed-dotted line.
  • a circumferential segment 41 is formed between two adjacent threading holes 11 .
  • two adjacent circumferential segments 41 pass through the threading holes 11 between the two circumferential segments 41 , and the two straight segments 42 are respectively connected in the threading holes 11 between the two circumferential segments 41 .
  • One end of the circumferential segment 41 is also formed.
  • the pulling part 44 pulls the winding part 43 at the position 0, the 10 linear segments 42 move synchronously and act on one circumferential segment 41 two by two to form the holding of the waist 12 of the elastic support frame 10, so that the waist 12 is held in place.
  • the diameter is uniformly reduced or enlarged.
  • the diameter-adjusting wire 40 forms each circumferential segment 41 in sequence along the circumferential direction of the waist portion 12 .
  • the diameter-adjusting wire 40 can also be passed through the 3# threading hole 11 and the 4# threading hole 11. Or any one of the 5# threading holes 11 is passed through. That is to say, in the winding method of FIG. 6 , the adjacent two circumferential segments 41 can be formed sequentially or occasionally, as long as the shape of the diameter-adjusting wire 40 formed at the waist 12 of the elastic support frame 10 is adjacent to each other.
  • the five-petal "petal” structure can achieve the above-mentioned beneficial effect of uniformly enlarging or reducing the diameter of the waist 12 .
  • the shape of the petals in this embodiment is five petals.
  • the shape of the petals can be any number greater than or equal to two, which can achieve similar beneficial effects.
  • FIG. 7 Another winding method of the diameter-adjusting wire 40 can be seen in FIG. 7 .
  • both ends of each circumferential segment 41 are respectively connected with a straight line segment 42 at the positions of the two threading holes 11 spaced apart. That is, in the winding method of FIG. 7 , the circumferential segment 41 no longer passes through the adjacent threading holes 11 , but bypasses one or more threading holes 11 and passes through the spaced threading holes 11 , to The extent of the waist 12 held by each circumferential segment 41 is increased.
  • the number of threading holes 11 of the waist portion 12 is 8, which is an even number.
  • the winding sequence is: 1# threading hole 11 ⁇ 3 #Threading hole 11 ⁇ Position 0 ⁇ 3#Threading hole 11 ⁇ 5#Threading hole 11 ⁇ Position 0 ⁇ 5#Threading hole 11 ⁇ 7#Threading hole 11 ⁇ Position 0 ⁇ 7#Threading hole 11 ⁇ 1#Threading hole 11 ⁇ position 0.
  • the starting point and the ending point of the final adjusting wire 40 are fixed at position 0 by the winding portion 43 .
  • the diameter-adjusting wire 40 forms a similar four-lobed "petal" shape on the elastic support frame 10 .
  • each circumferential segment 41 passes through one threading hole 11 and then passes through the next threading hole 11 spaced from the threading hole 11 with which it is initially wound.
  • Such a winding method expands the scope of action of each circumferential segment 41, while maintaining the uniform traction force of the circumferential segment 41 acting on the waist 12 when adjusting the diameter, it also saves the length of the diameter-adjusting line 40 and simplifies the room of the present invention.
  • the winding step of the spacer ostomy device 100 For the convenience of distinction, a "petal" in Figure 7 is represented by a dashed-dotted line.
  • the number of threading holes 11 is an odd number, and the circumferential segments 41 still pass through the spaced threading holes 11 to form windings, increasing the number of each circumferential segment 41.
  • the circumferential segments 41 also overlap each other, so that at least a part of the waist 12 is held by the two circumferential segments 41 at the same time, so as to further uniform the force in the region and improve the precision and fineness of the diameter adjustment.
  • the winding sequence of the wire can be expressed as: 1# threading hole 11 ⁇ 3# threading hole 11 ⁇ position 0 ⁇ 2# Threading hole 11 ⁇ 4# Threading hole 11 ⁇ Position 0 ⁇ 3# Threading hole 11 ⁇ 5# Threading hole 11 ⁇ Position 0 ⁇ 4# Threading hole 11 ⁇ 1# Threading hole 11 ⁇ Position 0 ⁇ 5# Threading hole 11 ⁇ 2# Threading hole 11 ⁇ Position 0.
  • the starting point and the ending point of the final adjusting wire 40 are fixed at position 0 by the winding portion 43 .
  • the five-lobed “petal” shape formed by the diameter adjusting wire 40 on the elastic support frame 10 overlap each other two by two on the cross-sectional circle of the waist 12, and the action areas of the circumferential segments 41 also overlap each other two by two.
  • a "petal” in Figure 8 is represented by a dashed-dotted line.
  • the area between the adjacent threading holes 11 on the waist 12 is simultaneously held by the two circumferential segments 41, and the holding of the two circumferential segments 41 to the same area of the waist 12 can be balanced and restricted by each other. , so that the traction force received by this area during the diameter adjustment process is more balanced, thereby ensuring that the overall force of the waist 12 is uniform, avoiding irregular deformation of the waist 12 during the diameter adjustment process, and improving the accuracy of the diameter adjustment. level of sophistication.
  • winding method of the diameter-adjusting wire 40 shown in FIG. 7 or FIG. 8 and the winding order of the threading holes 11 can also be adjusted according to actual needs. Winding to further expand the action area of each circumferential segment 41, or setting the formation order of each "petal" to be reversed or disordered relative to the above-mentioned order, etc., will not affect the beneficial effects formed by the above-mentioned embodiments.
  • the number of diameter adjustment wires 40 is two, including a third diameter adjustment wire 403 and a fourth diameter adjustment wire 404 .
  • the fourth diameter adjustment line 404 in FIG. 9 is represented by a dashed-dotted line.
  • the third diameter-adjusting wire 403 and the fourth diameter-adjusting wire 404 are simultaneously used to form the circumferential section 41 and the straight section 42 .
  • FIG. 9 In the illustration of FIG.
  • the number of threading holes 11 at the waist 12 is 8, and the third diameter adjusting wire 403 is used to form four circles from the 1# threading hole 11 to the 5# threading hole in the clockwise direction segment 41, and each straight segment 42 connected between the four circumferential segments 41 and position 0; the fourth diameter adjusting wire 404 is used to form the 5# threading hole 11 in the clockwise direction to the 1# threading hole 11.
  • the four circumferential segments 41 and the respective straight segments 42 connected between the four circumferential segments 41 and position 0 need to be noted that the formation sequence of the multiple circumferential segments 41 and the multiple linear segments 42 is not limited. 41 and straight segments 42 may be formed in a clockwise, counterclockwise or other sequence. Or described as, in the embodiment of FIG.
  • the waist 12 is divided into two sides along the diameter direction, wherein the third adjusting line 403 is used to form each straight segment 42 and the circumferential segment 41 on one side, and the fourth adjusting line 404 is used to form each straight segment 42 and circumferential segment 41 on the other side.
  • Such a winding method enables the pulling section 44 to respectively drive the third diameter adjusting wire 403 to adjust the diameter of one side of the waist 12 and drive the fourth diameter adjusting wire 404 to adjust the other side of the waist 12 when pulling the winding portion 43 . diameter of the side.
  • Two diameter adjustment wires 40 are used to control the diameter adjustment of the waist portion 12 at the same time. Compared with the winding method using only one diameter adjustment wire 40, the length of a single diameter adjustment wire 40 in this embodiment is shorter, and the length of the single diameter adjustment wire 40 passing through it is shorter.
  • the number of threading holes 11 is less, and the number of threading holes 11 to be wound and the number of times of winding with the winding part 43 are less, which can effectively reduce the friction force generated by each diameter-adjusting wire 40 during the diameter-adjusting process, and ensure that the diameter-adjusting wire 40 is relatively opposite to each other.
  • the sliding of the elastic support frame 10 or the wrapping portion 43 is more stable, no local jamming phenomenon is caused, and the shape of the waist portion 12 is guaranteed to be regular.
  • FIG. 10 For another winding method, please refer to FIG. 10 .
  • the circumferential segments 41 formed by the third diameter-adjusting wire 403 and the fourth diameter-adjusting wire 404 still do not overlap, and the third diameter-adjusting wire 403 and the fourth diameter-adjusting wire 404 are formed by Circumferential segments 41 alternately cover the outer side of the waist 12 .
  • the two straight line segments 42 between any threading hole 11 and the winding portion 43 are formed by the third diameter adjustment line 403 and the fourth diameter adjustment line 404 respectively, and are adjacent to each other.
  • the two circumferential segments 41 are also formed by different diameter adjusting wires 40 . Compared with the winding method in FIG.
  • the distribution area of a single diameter-adjusting wire 40 on the circumference of the waist portion 12 in this embodiment is larger and more uniform.
  • the circumferential segment 41 formed by one of the diameter-adjusting wires 40 is stuck during the working process, the circumferential segments 41 formed by the other diameter-adjusting wire 40 located on both sides of the circumferential segment 41 can face the waist 12 . Holding is performed to ensure that the shape of the waist 12 remains regular.
  • the path of the fourth diameter adjustment line 404 in FIG. 10 is represented by a dashed-dotted line.
  • the number of the diameter-adjusting wires 40 used in the interatrial septostomy device 100 of the present invention can continue to be superimposed, and the plurality of diameter-adjusting wires 40 are respectively used to form a part of the circumferential segment 41, and a straight line segment 42 connected between the circumferential segment 41 and the winding portion 43 .
  • the arrangement of the plurality of diameter-adjusting wires 40 can further reduce the winding length of a single diameter-adjusting wire 40 , and reduce the influence of the irregular shape of the waist 12 caused by the jamming of the diameter-adjusting wires 40 .
  • the circumferential segments 41 formed by the two or more diameter-adjusting wires 40 may also overlap each other.
  • the waist portion 12 is restricted to balance the pulling force received by the waist portion 12 during diameter adjustment.
  • the diameter-adjusting wire 40 of the interatrial septostomy device 100 includes a first diameter-adjusting wire 401 for forming a circumferential segment 41 , and a second diameter-adjusting wire 402 for forming a straight segment 42 , the second diameter-adjusting wire 402 passing through the thread
  • the hole 11 is hooked up with the first diameter adjusting wire 401 .
  • the first diameter-adjusting wire 401 is a closed wire loop
  • the first diameter-adjusting wire 401 is arranged around the outer side of the waist 12 of the elastic support frame 10 to form a circumferential segment 41 covering a complete circumference of the waist 12 , to achieve the retention of the waist 12 .
  • the second diameter-adjusting wire 402 is repeatedly wound between the winding portion 43 and each threading hole 11 to form a straight segment 42 , wherein the second diameter-adjusting wire 402 for forming the straight segment 42 passes through each threading hole 11 and passes from each threading hole 11 .
  • the threading hole 11 bypasses the outside of the first diameter-adjusting wire 401 fixed on the outer side of the waist 12 , and after forming a hook with the first diameter-adjusting wire 401 , it is then passed back through the threading hole 11 to the winding portion 43 .
  • the first diameter adjustment line 401 in FIG. 11 and FIG. 12 is represented by a dashed-dotted line.
  • the second diameter adjusting wire 402 can drive the sleeved first diameter adjusting wire 401 to be partially recovered into the threading hole 11 , so that the The circumference of the circumferential section 41 formed by the first diameter-adjusting wire 401 for holding the waist 12 becomes smaller, so as to achieve the effect of reducing and adjusting the diameter of the waist 12 .
  • the circumferential section 41 and the straight section 42 are respectively composed of different diameter-adjusting wires 40, and the second diameter-adjusting wire 402 is only hooked to the first diameter-adjusting wire 401 at the position of the threading hole 11, which can also achieve the above-mentioned
  • the force of the waist 12 is uniform, and the beneficial effect of the regular shape of the waist 12 is limited.
  • the elastic support frame 10 includes at least three support parts 13 surrounding its axis (or the multi-lumen tube 20).
  • the support parts 13 are grid-shaped hollow structures, and Each support portion 13 is provided with at least one threading hole 11 . Further, each support portion 13 needs to provide a part of support structures on both sides of the waist portion 12 respectively, so as to fit the inner walls of the left and right ventricles and form support for the waist portion 12 .
  • the structure of the elastic support frame 10 is enclosed.
  • the elastic support frame 10 includes 10 hollow support parts 13 , and the threading holes 11 are arranged at the positions of the support parts 13 corresponding to the waist part 12 of the elastic support frame 10 .
  • the support parts 13 of the hollow structure are arranged along the circumferential direction of the elastic support frame 10 and are used to form the main structure of the elastic support frame 10 . Because the elastic support frame 10 needs to be retracted and wrapped outside the multi-lumen tube 20 in the delivery state, and the sheath tube 101 needs to be sheathed outside the elastic support frame 10, the hollow structure of the support portion 13 is more conducive to its shrinkage and deformation, and control The volume occupied after retraction.
  • the threading hole 11 is provided on the connecting portion 14 between two adjacent supporting portions 13 , and the plurality of supporting portions 13 are combined into a whole to improve the overall rigidity of the elastic support frame 10 .
  • ten supporting parts 13 are integrally connected to each other by ten connecting parts 14 .
  • the threading hole 11 is also provided on the support portion 13 .
  • five threading holes 11 are provided, which are provided on the supporting parts 13 spaced apart from each other. It can be understood that, in other embodiments, the threading hole 11 may also be provided on each connecting portion 14 , so as to wrap more diameter adjusting wires 40 in the spacer stoma device 100 .
  • the openings of each threading hole 11 are also arranged to face its axis (or the axis of the multi-lumen tube 20 ). Therefore, the straight section 42 of the diameter-adjusting wire 40 can directly pass through the threading hole 11 along the radial direction of the waist 12, thereby reducing the friction between the straight section 42 and the threading hole 11.
  • the handle 30 includes a base body 32 and a diameter adjusting member 31 .
  • the diameter adjusting member 31 rotates around the base body 32 to pull the traction segment 44, so that the traction segment 44 moves along the axis of the atrial septostomy device 100 (or the multi-lumen tube 20), and sequentially drives the winding portion 43, the straight segment 42 and the Circumferential section 41 to adjust the diameter of the elastic support frame 10 at the waist 12 .

Landscapes

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

Abstract

Dispositif de septostomie auriculaire (100), comprenant un cadre de support élastique (10), une poignée (30) et au moins une ligne de réglage de diamètre (40). La taille (12) du cadre de support élastique (10) est pourvue d'une électrode destinée à l'ablation d'un tissu cible et la taille (12) du cadre de support élastique (10) est en outre pourvue d'une pluralité de trous de filetage (11) le long de la direction circonférentielle. La ligne de réglage de diamètre (40) est enroulée parmi les trous de filetage (11) et reliée à la poignée (30), et la poignée (30) tire la ligne de réglage de diamètre (40) pour modifier le diamètre de la taille (12), une ligne de réglage de diamètre (40) passant à travers au moins trois trous de filetage (11). Selon le dispositif de septostomie auriculaire (100), le nombre de lignes de réglage de diamètre (40) est réduit, le mode d'enroulement de la ligne de réglage de diamètre (40) sur le cadre de support élastique (10) est simplifié, et la régularité de traction de la ligne de réglage de diamètre (40) est améliorée. De plus, après la réduction du nombre de lignes de réglage de diamètre (40), l'influence mutuelle des lignes de réglage de diamètre devient faible dans un processus de réglage de taille, la force appliquée sur le cadre de support élastique (10) est plus uniforme, et il peut être garanti que la forme d'un canal de dérivation soit régulière.
PCT/CN2021/108733 2020-07-30 2021-07-27 Dispositif de septostomie auriculaire Ceased WO2022022528A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN202010756181.6 2020-07-30
CN202010756181.6A CN114052889A (zh) 2020-07-30 2020-07-30 房间隔造口装置
CN202021570248.9U CN212490130U (zh) 2020-07-30 2020-07-30 房间隔造口装置
CN202021570248.9 2020-07-30

Publications (1)

Publication Number Publication Date
WO2022022528A1 true WO2022022528A1 (fr) 2022-02-03

Family

ID=80037628

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2021/108733 Ceased WO2022022528A1 (fr) 2020-07-30 2021-07-27 Dispositif de septostomie auriculaire

Country Status (1)

Country Link
WO (1) WO2022022528A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN118948508A (zh) * 2024-08-19 2024-11-15 杭州糖吉医疗科技有限公司 用于支架回收的自锁装置、支架和支架的回收方法

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108784896A (zh) * 2017-10-31 2018-11-13 杭州诺生医疗科技有限公司 房间隔造口装置、房间隔造口系统及其操作方法
WO2019085841A1 (fr) * 2017-10-31 2019-05-09 杭州诺生医疗科技有限公司 Dispositif de septostomie auriculaire, système de septostomie auriculaire, leur procédé de fonctionnement et procédé de création d'ouverture
CN209360888U (zh) * 2018-11-09 2019-09-10 杭州诺生医疗科技有限公司 房间隔造口装置及其房间隔造口系统
CN211934281U (zh) * 2019-12-31 2020-11-17 杭州诺生医疗科技有限公司 造口系统
CN212015753U (zh) * 2019-12-31 2020-11-27 杭州诺生医疗科技有限公司 造口系统
CN212490130U (zh) * 2020-07-30 2021-02-09 杭州诺生医疗科技有限公司 房间隔造口装置
CN112603524A (zh) * 2020-11-30 2021-04-06 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

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108784896A (zh) * 2017-10-31 2018-11-13 杭州诺生医疗科技有限公司 房间隔造口装置、房间隔造口系统及其操作方法
WO2019085841A1 (fr) * 2017-10-31 2019-05-09 杭州诺生医疗科技有限公司 Dispositif de septostomie auriculaire, système de septostomie auriculaire, leur procédé de fonctionnement et procédé de création d'ouverture
CN209360888U (zh) * 2018-11-09 2019-09-10 杭州诺生医疗科技有限公司 房间隔造口装置及其房间隔造口系统
CN211934281U (zh) * 2019-12-31 2020-11-17 杭州诺生医疗科技有限公司 造口系统
CN212015753U (zh) * 2019-12-31 2020-11-27 杭州诺生医疗科技有限公司 造口系统
CN212490130U (zh) * 2020-07-30 2021-02-09 杭州诺生医疗科技有限公司 房间隔造口装置
CN112603524A (zh) * 2020-11-30 2021-04-06 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

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN118948508A (zh) * 2024-08-19 2024-11-15 杭州糖吉医疗科技有限公司 用于支架回收的自锁装置、支架和支架的回收方法

Similar Documents

Publication Publication Date Title
US12102308B2 (en) Braided hemostasis shaft for improved torsional response
US8475378B2 (en) Method and apparatus for performing transesophageal cardiovascular procedures
JP3233627U (ja) 消化管セルフ吻合クリップ及びそのリリース装置
US10368942B2 (en) Devices and methods for treating cardiac tissue
WO2023240787A1 (fr) Cathéter à courbure réglable
CN212490130U (zh) 房间隔造口装置
US20230248556A1 (en) Control handle, bending control line and implant delivery device
CN105263444A (zh) 用于折叠或展开医疗植入物的设备、以及植入物
EP3744264B1 (fr) Dispositif d'occlusion et dispositif médical
WO2022022528A1 (fr) Dispositif de septostomie auriculaire
CN108670330A (zh) 外科手术用腔镜戳孔简易缝合装置
WO2023116837A1 (fr) Dispositif de fermeture et système de fermeture
CN114748117A (zh) 一种基于医疗腹腔镜使用的撑开组件
CN117426818A (zh) 一种用于介入治疗的缝合装置
CN109452992A (zh) 造口器械
CN211934273U (zh) 用于肺部神经消融的射频消融导管
CN112971883A (zh) 一种大伤口血管缝合装置
CN114052889A (zh) 房间隔造口装置
CN211934272U (zh) 网笼式的射频消融导管
WO2022002086A1 (fr) Dispositif d'occlusion et système d'occlusion
CN111000598B (zh) 封堵器
CN216317765U (zh) 一种用于开放腹腔术后的收线器
CN117426813A (zh) 一种带有磁性件的心脏介入缝合装置
CN216257330U (zh) 一种免缝合主动脉停跳液针
CN211325222U (zh) 介入引导装置

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: 21850217

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: 21850217

Country of ref document: EP

Kind code of ref document: A1