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WO2026000367A1 - Ensemble panier et cathéter à panier - Google Patents

Ensemble panier et cathéter à panier

Info

Publication number
WO2026000367A1
WO2026000367A1 PCT/CN2024/102560 CN2024102560W WO2026000367A1 WO 2026000367 A1 WO2026000367 A1 WO 2026000367A1 CN 2024102560 W CN2024102560 W CN 2024102560W WO 2026000367 A1 WO2026000367 A1 WO 2026000367A1
Authority
WO
WIPO (PCT)
Prior art keywords
connector
distal
basket assembly
proximal
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.)
Pending
Application number
PCT/CN2024/102560
Other languages
English (en)
Chinese (zh)
Inventor
张媛
谢宇
冯君
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.)
Enchannel Medical Guangzhou Inc
Original Assignee
Enchannel Medical Guangzhou Inc
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
Application filed by Enchannel Medical Guangzhou Inc filed Critical Enchannel Medical Guangzhou Inc
Priority to PCT/CN2024/102560 priority Critical patent/WO2026000367A1/fr
Publication of WO2026000367A1 publication Critical patent/WO2026000367A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Definitions

  • This invention relates to the field of electrophysiological catheters, and more specifically to basket catheters and basket components of basket catheters.
  • Electrophysiology catheters can be used for cardiac electrophysiological mapping and cardiac ablation.
  • the diagnosis of arrhythmias often relies on high-density contact mapping techniques.
  • high-density contact mapping techniques During mapping, it is crucial to ensure good electrode contact with cardiac tissue to guarantee accuracy.
  • basket catheters i.e., mapping catheters with a basket structure, are frequently used because this structure can accommodate more electrodes.
  • the basket assembly of the basket catheter may include a distal connector, a proximal connector, and a spline connecting the distal connector and the proximal connector.
  • the spline may be made of materials such as nickel-titanium alloy, which has good elasticity. Electrodes may be set on the spline to achieve mapping and/or ablation.
  • the spline needs to have a certain stiffness.
  • the stiffness of the spline will limit the flexibility of the basket assembly, affect the deformation of the basket assembly, and make it difficult for the basket assembly to adhere well to the target biological tissue.
  • the present invention mainly solves the technical problem that the basket assembly is not easy to adhere well to the target biological tissue.
  • the present invention provides a basket assembly.
  • the basket assembly includes a near-end connector, a far-end connector, and a spline
  • the proximal connector is used for fixed connection of the proximal end of the spline
  • the distal connector is used for fixed connection of the distal end of the spline
  • the spline As the distal connector approaches and moves away from the proximal connector, the spline has a retracted state and an open state.
  • the spline includes:
  • a support frame wherein the support frame is elastic
  • a flexible connector is attached to the support frame.
  • the flexible connector includes an extended portion and a folded portion.
  • the extended portion protrudes from the distal end of the support frame.
  • the folded portion is connected to the extended portion and folded towards the proximal end of the basket assembly.
  • the folded portion is fixed to the distal end connector.
  • the flexible connector includes an arc-shaped bend portion connecting the extended portion and the reverse bend portion, the arc-shaped bend portion forming a "U" shape with the extended portion and the reverse bend portion, the opening of the "U" shape facing the proximal end of the basket assembly.
  • the arc-shaped bend protrudes beyond the distal end face of the distal connector, or the distal end of the arc-shaped bend is flush with the distal end face of the distal connector.
  • a flexible circuit board is included, the flexible circuit board including an insulating substrate and electrodes, and the flexible connector is formed from the flexible circuit board.
  • the flexible circuit board has an inner side surface, which is the side of the flexible circuit board near the line connecting the proximal connector and the distal connector, and a flexible reinforcing layer is provided on the inner side surface.
  • the flexible circuit board has an inner side surface, which is the side of the flexible circuit board near the line connecting the proximal connector and the distal connector, and the support frame is disposed on the inner side surface of the flexible circuit board.
  • a retaining ring is included, which is sleeved on the outside of the distal connector.
  • the folded portion has a fixing segment, which is disposed between the retaining ring and the outer peripheral surface of the distal connector.
  • a curing colloid is included, at least a portion of which is located on the distal side of the fixing ring, the curing colloid being elastic; the flexible connector has a transition section located on the distal side of the fixing section, the curing colloid fixing the transition section to the distal connector.
  • the proximal end of the support frame is parallel to the line connecting the proximal connector and the distal connector, the proximal end of the support frame is fixed to the proximal connector, and when the spline is in the retracted state, the folded portion is parallel to the support frame.
  • the present invention provides a basket guide tube.
  • Net basket conduit including:
  • An insertion tube is connected to the distal end of the handle
  • a basket assembly wherein the basket assembly is any one of the basket assemblies described above, and the basket assembly is connected to the distal end of the insertion tube;
  • a pull rod which is movably disposed in the insertion tube and is connected to the distal connector of the basket assembly to drive the distal connector toward and away from the proximal connector.
  • a spline is connected between a distal connector and a proximal connector.
  • the elastic support frame allows the spline to have a retracted and open state.
  • the spline includes a flexible connector.
  • the extended portion of the flexible connector, protruding from the distal end of the support frame, is connected to a folded portion, which is fixed to the distal connector. This folded portion allows the distal portion of the spline to flexibly deflect circumferentially along the basket assembly, move radially along the basket assembly, or undergo a certain degree of torsional deformation through its own deformation. This provides good self-adaptability when the basket assembly is in contact with the target biological tissue, making it easier to adhere to the target biological tissue.
  • the flexible deformation of the folded part can prevent the basket assembly from making hard contact with the organism, which helps to avoid scratching the organism, improves safety, and also helps to prevent the spline from breaking due to excessive stress.
  • Figure 1 is a schematic diagram of an embodiment of the basket assembly of the present invention in the fully open state
  • Figure 2 is a magnified view of the spline area in Figure 1;
  • Figure 3 is a cross-sectional view of the connection between the spline and the distal connector in Figure 2;
  • Figure 4 is a perspective view of the connection between the spline and the distal connector in Figure 2;
  • Figure 5 is a partial three-dimensional view of the basket assembly in Figure 1 when it is in the retracted state.
  • Figure 6 is a cross-sectional view of the basket assembly in Figure 5;
  • Figure 7 is a schematic diagram of the structure of the distal part of the spline in Figure 6.
  • connection and “linkage” used in this application, unless otherwise specified, include both direct and indirect connections (linkages).
  • the spline 300 of the basket assembly is provided with a flexible connector 330.
  • the distal end of the flexible connector 330 is provided with a folded portion 333, which is fixed on the distal connector 200, forming a deformable hinge structure. This allows the spline 300 to move adaptively when subjected to the reaction force of the target biological tissue, thereby making it easier to adhere to the target biological tissue.
  • the basket assembly includes a proximal connector 100, a distal connector 200, and a spline 300.
  • the proximal connector 100 provides a proximal fixed connection for the spline 300
  • the distal connector 200 provides a distal fixed connection for the spline 300.
  • proximal and distal used in this article are conventional terms in the medical field.
  • the proximal end is the end closer to the operator, and the distal end is the end farther away from the operator.
  • the distal end is usually the end that enters the patient's body first.
  • the proximal and distal ends can be referred to the orientation shown in Figure 1.
  • the proximal connector 100 can be a section of tubing, the inner cavity of which forms a connecting cavity for the proximal insertion and fixed connection of the spline 300.
  • the specific fixing method between the spline 300 and the proximal connector 100 is not limited; for example, they can be fixedly connected by bonding, welding, or other methods.
  • the proximal connector 100 can be connected to the insertion tube of the basket conduit, allowing the basket assembly to be transported to the target location by the insertion tube.
  • the distal connector 200 is a sleeve structure.
  • a central hole in the sleeve allows a pull rod 500 to be connected, enabling the distal connector 200 to move via the pull rod 500.
  • a sensor 600 can also be installed within the central hole of the distal connector 200.
  • the sensor 600 is used for position detection of the basket assembly; for example, it can be a magnetoelectric positioning sensor.
  • the pull rod 500 can pass through the insertion tube of the basket guide tube and connect to the handle of the basket guide tube.
  • a drive button can be installed on the handle. Operating the drive button moves the pull rod 500 towards the distal or proximal end of the basket assembly, thereby driving the distal connector 200 to move towards the distal or proximal end of the basket assembly via the pull rod 500.
  • proximal connector 100 and the distal connector 200 can be replaced with other structural forms, as long as the spline 300 can be installed; the accessories connected to the proximal connector 100 and the distal connector 200 can also be set as needed.
  • specific structure of the pull rod 500 and the handle can refer to existing structures in related technologies, and considering that they are not directly related to the innovative content of this application and the technical problem to be solved, they will not be described in detail here.
  • the proximal connector 100 is fixed to the insertion tube 700, when the distal connector 200 moves towards the proximal end of the basket assembly, the distal connector 200 gradually approaches the proximal connector 100, and the basket assembly gradually opens from a retracted state until it reaches its maximum stroke, at which point the basket assembly is in a fully open state.
  • the spline 300 can smoothly bend radially outwards towards the basket assembly, as shown in Figures 1 to 4.
  • the open state of the basket assembly refers to the state in which the basket assembly can be used for electrophysiological mapping or ablation of the heart; the basket assembly can have different degrees of opening depending on the morphology and size of the target biological tissue.
  • Figures 1 to 4 only show the state when the basket assembly is fully open.
  • the structure of the spline 300 itself and the connection structure of the spline 300 between the proximal connector 100 and the distal connector 200 will affect the opening shape of the basket assembly, which will be described in detail below. It should be noted that the number of splines 300 is not limited in this invention.
  • spline 300 may include a support frame 310 and a flexible circuit board 320.
  • the support frame 310 is elastic and can be made of an elastic metal, such as a nickel-titanium alloy, which has good biocompatibility and can rebound well to its initial shape after being deformed by external force.
  • the support frame 310 can be a straight structure, allowing the spline 300 to be close to the distal connector 200 and the pull rod 500, thus minimizing the radial dimension of the basket assembly.
  • the support frame 310 can be sheet-like, facilitating the connection of the flexible circuit board 320.
  • the support frame 310 can also be replaced with other forms, such as a linear form.
  • the flexible circuit board 320 has an inner side surface, which is the side of the flexible circuit board 320 near the line connecting the proximal connector 100 and the distal connector 200.
  • the support frame 310 can be disposed on the inner side surface of the flexible circuit board 320, so that the electrodes 322 on the flexible circuit board 320 face the outer side of the basket assembly, thereby enabling them to adhere to the target biological tissue.
  • the flexible circuit board 320 can be fixed to the support frame 310 by adhesive bonding, and the adhesive can be polyurethane glue, UV glue, epoxy resin, acrylic resin, etc.
  • the proximal end of the support frame 310 can be flush with the proximal end of the spline 300, and the portion of the support frame 310 and the flexible circuit board 320 connected to the support frame 310 together form the main body of the spline.
  • the flexible circuit board 320 may include an insulating substrate 321 and electrodes 322.
  • the insulating substrate 321 may be made of polyimide (PI), polyethylene terephthalate (PET), etc.
  • the electrodes 322 may be made of platinum-iridium alloy, stainless steel alloy, copper, etc.
  • the bonding method of the electrodes 322 to the insulating substrate 321 is not limited; for example, they can be bonded to the insulating substrate 321 by means of bonding, etching, plating, etc.
  • the electrodes 322 have exposed discharge surfaces and can form an electric field during use.
  • the flexible circuit board 320 may also include a cover layer.
  • the material of the cover layer may be the same as that of the insulating substrate 321, and it can be bonded to the insulating substrate 321 by means of bonding, hot pressing, etc., providing protection for the circuit on the insulating substrate 321.
  • the length of the flexible circuit board 320 is greater than the length of the support frame 310.
  • the distal end of the flexible circuit board 320 extends beyond the distal end of the support frame 310, forming an overhang portion 331.
  • the flexible circuit board 320 includes a folded portion 333, which connects to the overhang portion 331 and folds towards the proximal end of the basket assembly. The folded portion 333 is fixed to the distal connector 200.
  • each corresponding spline 300 can be displaced relatively easily, for example, in the direction indicated by the bidirectional arrow in Figure 2, or in the radial direction corresponding to the corresponding spline 300 on the basket assembly. This can increase the compliance of the entire basket assembly, so as to fit more closely to the target biological tissue.
  • the flexible connector 330 can also prevent the spline 300 from breaking due to the tearing of the opening on the flexible circuit board 320 caused by external force, thus ensuring the reliability of the basket assembly.
  • the splines 300 of the basket cannula are arranged at intervals along the circumference.
  • the target biological tissue may enter the intervals between the splines 300.
  • the biological tissue may be easily scratched.
  • the flexible hinge formed by the extended portion 331 and the folded portion 333 can prevent hard contact between the splines 300 and the biological tissue, which helps to avoid the basket assembly scratching the biological tissue and improves the safety of the operation.
  • the flexible connector 330 may also be a separate structure independent of the flexible circuit board 320, such as a sheet structure formed of polyimide (PI), polyethylene terephthalate (PET), etc. Additionally, in some other embodiments, the proximal end of the flexible connector 330 may be directly connected to the distal end of the support frame 310.
  • PI polyimide
  • PET polyethylene terephthalate
  • the basket assembly may include a retaining ring 400, which is sleeved on the outside of the distal connector 200.
  • the folded portion 333 has a fixing section, which is the portion of the folded portion 333 located between the retaining ring 400 and the outer peripheral surface of the distal connector 200.
  • the folded portion 333 is inserted into the gap between the distal connector 200 and the retaining ring 400, and then glue is applied to bond and fix the folded portion 333 to the distal connector 200.
  • the retaining ring 400 can play an auxiliary fixing and positioning role, ensuring the uniform distribution of each spline 300.
  • the folded portion 333 can also be secured by the retaining ring 400.
  • the aforementioned fixing ring 400 can be a contrast ring, which can be used simultaneously for contrasting the tip of the basket catheter and fixing the flexible circuit board 320. This reduces the number of parts, saves space, and lowers costs.
  • the contrast ring in the ablation catheter can be made of precious metals such as platinum and iridium. Such rings are clearly visible under X-rays, allowing doctors to precisely control the catheter's position during the procedure.
  • a separate ring body can be used as the fixing ring 400, solely for fixing the folded portion 333 to the distal connector 200.
  • the folded portion 333 can be directly bonded to the outer peripheral surface of the distal connector 200 or the wall of the central hole of the distal connector 200.
  • the end of the folded portion 333 can also have an L-shaped bend, which fixes it to the end face of the distal connector 200.
  • a fixed connection area can be formed between the folded portion 333 and the distal connector 200, and there is a gap between the distal edge of the fixed connection area and the distal end of the flexible connector 330. This gap increases the flexibility of the spline 300 during the opening of the basket.
  • the fixed connection area corresponds to the fixed segment of the folded portion 333 and is distributed around the axis of the distal connector 200.
  • the flexible connector 330 includes an arc-shaped bend 332, which connects the extended portion 331 and the reverse bend 333.
  • the arc-shaped bend 332, the extended portion 331, and the reverse bend 333 form a "U" shape, with the opening of the "U" facing the proximal end of the basket assembly.
  • the bend allows for a smooth reverse bend of the flexible circuit board 320, which is more conducive to preventing breakage of the flexible circuit board 320.
  • the reverse bend 333 can also be directly folded back, forming a crease between the extended portion 331 and the reverse bend 333.
  • the arc-shaped bend 332 protrudes from the distal end face of the distal connector 200; in some other embodiments, the distal end of the arc-shaped bend 332 may also be flush with the distal end face of the distal connector 200.
  • the aforementioned protruding or flush structure increases the flexibility of the spline 300's movement and makes the distal side of the basket assembly flatter after opening, preventing the distal connector 200 from protruding from the spline 300.
  • this allows the electrode 322 to better adhere to the target biological tissue.
  • the pressure generated is also lower compared to a structure where the distal connector protrudes from the spline, thus increasing patient safety.
  • the distal end of the arc-shaped bend 332 may be closer to the proximal end of the basket assembly than the distal end face of the distal connector 200.
  • the basket assembly may further include a curable adhesive (not shown in the figure), at least a portion of which is located on the distal side of the fixing ring 400.
  • the curable adhesive is elastic.
  • the curable adhesive can be formed by curing polyurethane, epoxy resin, acrylate, or other adhesives.
  • the flexible connector 330 has a transition section located on the distal side of the fixing section, and the curable adhesive fixes the transition section to the distal connector 200. By providing the curable adhesive and the transition section, the elastic curable adhesive can deform along with the flexible connector 330, providing cushioning and protection.
  • the flexible connector 330 formed by the flexible circuit board 320 will not rub against or be cut by the fixing ring 400 during movement, which helps prevent breakage of the flexible circuit board 320 and improves the operational reliability of the basket assembly.
  • the flexible circuit board 320 includes a flexible reinforcing layer 323 disposed on the inner surface of the flexible circuit board 320.
  • the flexible reinforcing layer 323 can be polyurethane, polyimide, polyethylene fiber, polyester fiber, nylon fiber, polyester fiber, polyethylene terephthalate, etc.
  • the flexible reinforcing layer 323 can be bonded and fixed to the side of the insulating substrate 321 facing away from the electrode 322.
  • the flexible reinforcing layer 323 can be bent synchronously with the insulating substrate 321 to improve the bending fatigue strength of the flexible circuit board 320.
  • the flexible reinforcing layer 323 can have the same width as the insulating substrate 321; in some other embodiments, the width of the flexible reinforcing layer 323 can be smaller or larger than the insulating substrate 321.
  • the flexibility of the flexible reinforcing layer 323 should be greater than the flexibility of the supporting frame 310, that is, it can be deformed more easily than the supporting frame 310.
  • the flexible reinforcing layer 323 can be provided only at the location on the flexible circuit board 320 used to form the flexible connector 330, or it can be provided on the entire flexible circuit board 320.
  • the proximal end of the support frame 310 is parallel to the line connecting the proximal connector 100 and the distal connector 200.
  • the proximal end of the support frame 310 is fixed to the proximal connector 100.
  • the folded portion 333 is parallel to the support frame 310.
  • the basket assembly can form a pear-shaped structure with a larger distal diameter and a smaller proximal diameter when opened, making it easier to meet mapping or ablation requirements.
  • the folded portion 333 may also have an angle with the axis of the basket assembly.
  • the basket assembly including the aforementioned flexible connector 330 can be used for electrophysiological mapping of the heart. In some other embodiments, the basket assembly including the aforementioned flexible connector 330 can also be used for cardiac ablation, such as pulsed electric field ablation (PFA) or radiofrequency ablation (RF).
  • PFA pulsed electric field ablation
  • RF radiofrequency ablation
  • the basket guide tube includes a handle, an insertion tube, a basket assembly, and a pull rod 500.
  • the insertion tube is connected to the distal end of the handle, and the basket assembly is connected to the distal end of the insertion tube.
  • the basket assembly is any of the basket assemblies described in the above embodiments, and will not be repeated here.
  • the pull rod 500 is movably disposed in the insertion tube and is connected to the distal end connector 200 of the basket assembly to drive the distal end connector 200 closer to and further away from the proximal end connector 100.

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  • Surgical Instruments (AREA)

Abstract

La présente invention se rapporte au domaine des cathéters électrophysiologiques, et concerne en particulier un cathéter à panier et un ensemble panier du cathéter à panier. Sont décrits un ensemble panier et un cathéter à panier. L'ensemble panier comprend une base de connexion proximale, une base de connexion distale, et des cannelures. La base de connexion proximale est conçue pour être connectée de manière fixe à des extrémités proximales des cannelures, et la base de connexion distale est conçue pour être connectée de manière fixe à des extrémités distales des cannelures. Pendant des processus au cours desquels la base de connexion distale se rapproche et s'éloigne de la base de connexion proximale, les cannelures présentent un état fermé et un état ouvert. La cannelure comprend : un cadre de support présentant une certaine élasticité ; et un élément de connexion flexible fixé au cadre de support. L'élément de connexion flexible comprend une partie d'extension et une partie de pliage inverse. La partie d'extension est exposée au-delà d'une extrémité distale du cadre de support, la partie de pliage inverse est connectée à la partie d'extension et pliée vers une extrémité proximale de l'ensemble panier, et la partie de pliage inverse est fixée à la base de connexion distale. La présente invention résout principalement le problème technique selon lequel l'ensemble panier n'est pas facilement bien fixé au tissu biologique cible.
PCT/CN2024/102560 2024-06-28 2024-06-28 Ensemble panier et cathéter à panier Pending WO2026000367A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/CN2024/102560 WO2026000367A1 (fr) 2024-06-28 2024-06-28 Ensemble panier et cathéter à panier

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/CN2024/102560 WO2026000367A1 (fr) 2024-06-28 2024-06-28 Ensemble panier et cathéter à panier

Publications (1)

Publication Number Publication Date
WO2026000367A1 true WO2026000367A1 (fr) 2026-01-02

Family

ID=98220547

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2024/102560 Pending WO2026000367A1 (fr) 2024-06-28 2024-06-28 Ensemble panier et cathéter à panier

Country Status (1)

Country Link
WO (1) WO2026000367A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104434083A (zh) * 2013-09-16 2015-03-25 韦伯斯特生物官能(以色列)有限公司 具有可挠曲脊的网篮导管技术领域
CN114191071A (zh) * 2021-11-19 2022-03-18 杭州德诺电生理医疗科技有限公司 消融装置
CN114343831A (zh) * 2020-10-12 2022-04-15 伯恩森斯韦伯斯特(以色列)有限责任公司 具有球囊的篮状导管
CN115736931A (zh) * 2023-01-05 2023-03-07 心航路医学科技(广州)有限公司 网篮电极及网篮导管
CN116549093A (zh) * 2022-01-28 2023-08-08 心航路医学科技(广州)有限公司 超声双层网篮消融导管
CN118236157A (zh) * 2024-05-27 2024-06-25 心航路医学科技(广州)有限公司 网篮电极骨架、网篮电极组件及网篮导管

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104434083A (zh) * 2013-09-16 2015-03-25 韦伯斯特生物官能(以色列)有限公司 具有可挠曲脊的网篮导管技术领域
CN114343831A (zh) * 2020-10-12 2022-04-15 伯恩森斯韦伯斯特(以色列)有限责任公司 具有球囊的篮状导管
CN114191071A (zh) * 2021-11-19 2022-03-18 杭州德诺电生理医疗科技有限公司 消融装置
CN116549093A (zh) * 2022-01-28 2023-08-08 心航路医学科技(广州)有限公司 超声双层网篮消融导管
CN115736931A (zh) * 2023-01-05 2023-03-07 心航路医学科技(广州)有限公司 网篮电极及网篮导管
CN118236157A (zh) * 2024-05-27 2024-06-25 心航路医学科技(广州)有限公司 网篮电极骨架、网篮电极组件及网篮导管

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