Atrial maze-type pulsed electric field ablation catheter and device thereof

Abstract

The present invention relates to an atrial maze-type pulsed electric field ablation catheter and its equipment, belonging to the field of medical device technology. It includes a handle, a sheath, a plug, an annular adjustable catheter, a support guide wire, an annular electrode and an insulated wire; the handle is provided with a sheath, and the end of the sheath away from the operator is provided with a plug; an annular adjustable catheter is passed through the plug, and the annular adjustable catheter is provided with a support guide wire connected to the handle for adjusting the length of the annular adjustable catheter; the annular adjustable catheter is provided with an annular electrode, and the annular electrode is connected to the handle through an insulated wire. The present invention provides an ablation device consisting of an ablation catheter with adjustable ablation section length and adjustable curvature. It can achieve ablation in any direction in the atrium, and the ablation position is more flexible; it can achieve a variety of ablation paths, forming grid-type and maze-type ablation, and the ablation effect is more thorough; the ablation electrode with adjustable length can achieve ablation in a wider range.

Description

Technical Field

[0001] The present invention relates to an atrial maze-type pulsed electric field ablation catheter and its equipment, belonging to the technical field of medical devices. In the present invention, the end close to the operator is set as the proximal end, and the end away from the operator is set as the distal end. Background Art

[0002] In clinical procedures to eliminate atrial fibrillation, pulmonary vein isolation is often used to achieve electrical conduction block between the pulmonary veins and the atria, thereby eliminating atrial fibrillation. Ablation energy can be delivered in the form of radiofrequency, cryotherapy, or pulsed electric fields, and in the form of balloons or electrodes. Radiofrequency and pulsed electric field electrodes are typically arranged in straight, circular, or spiral shapes, placed against the pulmonary vein ostia to ablate myocardial cells, achieving ablation isolation. In existing technologies, ablation methods such as radiofrequency and cryotherapy can cause side effects such as pulmonary vein stenosis and esophageal damage, and are non-selective for different tissues, indiscriminately ablating myocardial cells, blood vessels, nerves, and other tissues during pulmonary vein ablation. In existing technologies, when pulsed electric field energy is combined with electrodes in linear, circular, or petal-shaped structures, the ablation site is limited to the vicinity of the pulmonary vein ostia, forming a continuous ablation zone to achieve electrical conduction block between the pulmonary veins and the atria. This can lead to incomplete ablation and recurrence, and the need to ablate multiple pulmonary veins requires frequent bending and positioning, which is time-consuming and complex for doctors operating in a radiation environment.

[0003] Currently in the field of electric pulse ablation, the ablation locations of most ablation catheters are at the ports and interiors of the pulmonary veins. Chinese patents No. CN201780005770 and CN201880033278 disclose an electrode structure for pulsed electric field ablation, which distributes the electrodes on different splines, which can be unfolded into petal-shaped structures and spherical structures, and can ablate the pulmonary vein ports and interiors, but cannot achieve ablation of other parts. Chinese patent No. CN201680046257 discloses an electrode structure for pulsed electric field ablation, which arranges the electrodes into a circular ring structure, and can only ablate the location of the pulmonary vein ports. Therefore, this technical field is in urgent need of a pulsed electric field ablation catheter and equipment with variable ablation position, reasonable ablation area, and thorough ablation. Summary of the Invention

[0004] The purpose of the present invention is to solve the technical problems of the prior art of single intra-atrial ablation position, fixed ablation area and incomplete ablation.

[0005] In order to achieve the purpose of solving the above problems, the technical solution adopted by the present invention is to provide an atrial maze pulsed electric field ablation catheter, including a handle, a sheath, a plug, an annular adjustable catheter, a support guide wire, an annular electrode and an insulated wire; the handle is provided with a sheath, and the end of the sheath away from the operator is provided with a plug; the annular adjustable catheter is passed through the plug, and the annular adjustable catheter is provided with a support guide wire connected to the handle for adjusting the length of the annular adjustable catheter; the annular adjustable catheter is provided with an annular electrode, and the annular electrode is connected to the handle through an insulated wire.

[0006] Preferably, the handle is provided with a driving button, which is connected to the supporting guide wire.

[0007] Preferably, a circular groove for rotating the plug is provided on the outer periphery of the plug; a rotating knob is provided on the handle, and a driving guide wire is provided between the rotating knob and the plug for connecting the rotating knob and the plug and rotating synchronously.

[0008] Preferably, the handle is provided with a bending knob for adjusting the curvature of the sheath.

[0009] Preferably, a highly elastic, pre-shaped annular support guide wire is provided in the annular adjustable catheter; and a plurality of annular electrodes are provided on the annular adjustable catheter.

[0010] Preferably, an electrical connector is provided on the handle, and an insulated wire is provided between the electrical connector and the ring electrode.

[0011] Preferably, the plug is a soft double-hole plug with two through holes, one of the two through holes is fixedly connected to one end of the annular adjustable conduit, and the other end of the movable annular adjustable conduit is passed through the other hole; a seal is provided between the through hole and the annular adjustable conduit.

[0012] Preferably, the plug is a soft single-hole plug with a through hole, one end of a movable annular adjustable conduit is passed through the through hole, the other end of the annular adjustable conduit is set as a closed end, and a seal is provided between the through hole and the annular adjustable conduit.

[0013] The present invention provides an ablation device composed of an atrial maze-type pulsed electric field ablation catheter. The ablation device also includes a high-voltage pulse generator and a control module. The control module is connected to the ablation catheter via the high-voltage pulse generator.

[0014] Compared with the prior art, the present invention has the following beneficial effects:

[0015] The present invention provides an ablation device consisting of an ablation catheter with adjustable ablation segment length and curvature. This device enables ablation in any direction within the atrium, providing greater flexibility in ablation location. It also enables diverse ablation paths, forming grid-like and maze-like ablations for more thorough ablation results. Furthermore, the device incorporates adjustable-length ablation electrodes, enabling a wider range of ablation. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 The diagram is a schematic diagram of an atrial maze-type pulsed electric field ablation catheter and its equipment structure according to the present invention.

[0017] Figure 2 Schematic diagram of the ablation catheter structure of the present invention.

[0018] Figure 3 This is a schematic diagram of the structure of the electrode ablation segment of the present invention.

[0019] Figure 4 Schematic diagram of the structure of a soft double-hole plug according to an embodiment of the present invention

[0020] Figure 5 Schematic diagram of ablation position in the atrial meridian direction of the present invention.

[0021] Figure 6 Schematic diagram of the area produced by ablation in the atrial meridian direction according to the present invention.

[0022] Figure 7 Schematic diagram of the ablation position in the atrial latitude direction of the present invention.

[0023] Figure 8 Schematic diagram of the area produced by atrial latitudinal ablation according to the present invention.

[0024] Figure 9 This is a schematic diagram of the structure of the electrode ablation segment according to an embodiment of the present invention.

[0025] Figure 10 This is a schematic diagram of the structure of a single-hole soft plug according to an embodiment of the present invention.

[0026] Figure numerals: 1. High-voltage pulse generator; 2. Control module; 3. Ablation catheter; 31. Handle; 32. Sheath; 33. Soft double-hole plug; 34. Annular adjustable catheter; 35. Ring electrode; 36. Support guide wire; 37. Insulated wire; 38. Round groove; 39. Rotary drive guide wire; 311. Bending knob; 312. Drive push button; 313. Electrical connector; 314. Rotating knob. DETAILED DESCRIPTION

[0027] In order to make the present invention more clearly understood, preferred embodiments are described in detail below with reference to the accompanying drawings:

[0028] like Figure 1-10 As shown, the present invention provides an atrial labyrinth pulsed electric field ablation catheter 3, comprising a handle 31, a sheath 32, a plug, an annular adjustable catheter 34, a support guidewire 36, a ring electrode 35, and an insulated wire 37. The handle 31 is provided with the sheath 32, with the plug provided at the end of the sheath 32 away from the operator. The plug passes through the annular adjustable catheter 34, which is provided with a support guidewire 36 connected to the handle 31 for adjusting the length of the annular adjustable catheter 34. The annular adjustable catheter 34 is provided with a ring electrode 35, which is connected to the handle 31 via an insulated wire 37. The handle 31 is provided with a drive button 312, which is connected to the support guidewire 36. The plug is provided with a circular groove 38 on its outer periphery for rotation. The handle 31 is provided with a rotation knob 314, and a rotation drive guidewire 39 is provided between the rotation knob 314 and the plug for synchronous rotation of the rotation knob 314 and the plug. The handle 31 is provided with a bending knob 311 for adjusting the curvature of the sheath 32. A highly elastic, pre-shaped annular support guide wire 36 is provided in the annular adjustable catheter 34; a plurality of annular electrodes 35 are provided on the annular adjustable catheter 34. An electrical connector 313 is provided on the handle 31, and an insulated wire 37 is provided between the electrical connector 313 and the annular electrode 35. The plug is configured as a soft double-hole plug 33 with two through holes, one of the two through holes is fixedly connected to one end of the annular adjustable catheter 34, and the other hole is provided with the other end of the movable annular adjustable catheter 34; a sealing member is provided between the through hole and the annular adjustable catheter 34. Optionally, the plug is configured as a soft single-hole plug with one through hole, one end of the movable annular adjustable catheter 34 is provided in the through hole, the other end of the annular adjustable catheter 34 is configured as a closed end, and a sealing member is provided between the through hole and the annular adjustable catheter 34.

[0029] The present invention provides an ablation device composed of an atrial maze-type pulsed electric field ablation catheter, which also includes a high-voltage pulse generator 1 and a control module 2. The control module 2 is connected to the ablation catheter 3 through the high-voltage pulse generator 1.

[0030] like Figure 1-10As shown, the present invention provides an ablation catheter 3 with adjustable ablation section length, rotation, and curvature to achieve adjustment in any direction, including a handle 31, a sheath 32, a soft double-hole plug 33, an annular adjustable catheter 34, a support guide wire 36, an annular electrode 35, and an insulated wire 37; the handle 31 is provided with a bending knob 311, a driving push button 312, a rotating knob 314, and an electrical connector 313. The bending knob 311 is connected to the distal end of the sheath 32 through a guide wire and a pull ring, and the driving push button 312 is connected to the distal end of the sheath 32 through a guide wire and a pull ring. The movable push button 312 is connected to the supporting guide wire 36, and the rotating knob 314 is connected to the soft double-hole plug 33 by rotating the driving guide wire 39. A semicircular groove 38 is provided on the distal end of the sheath 32, and the semicircular groove 38 accommodates the soft double-hole plug 33; the double holes of the soft double-hole plug 33 can accommodate the movement of the annular adjustable catheter 34 and maintain sealing; a highly elastic, predetermined annular supporting guide wire 36 is provided in the tube of the annular adjustable catheter 34; a ring electrode 35 and an insulated wire 37 are provided on the annular adjustable catheter 34.

[0031] like Figure 1-10 As shown, the ablation device of the present invention is composed of a high-voltage pulse generator 1, a control module 2, and an ablation catheter 3, wherein:

[0032] 1) The high-voltage pulse generator 1 is connected to the ablation catheter 3 via the electrical connector 313. The parameters of the pulses sent by the high-voltage pulse generator 1 are controlled and adjusted by the control module 2. The electrical pulses are transmitted to the ring electrode 35 via the insulated wire 37.

[0033] 2) The annular electrode 35 and the annular adjustable catheter 34 are integrated into one structure by heat melting, gluing, welding, etc.; the semicircular groove 38 is integrated into the distal end of the sheath tube 32 by heat melting, gluing, welding, etc.;

[0034] 3) Both ends of the support guide wire 36 are connected to the drive push button 312 via a common mechanical structure such as a gear and a rack. Pushing the drive push button 312 forward and backward drives the support guide wire 36, thereby adjusting the length of the annular adjustable catheter 34 exposed from the flexible double-hole plug 33 while maintaining a seal.

[0035] 4) The rotating knob 314 is connected to the soft double-hole plug 33 by rotating the driving guide wire 39 to achieve synchronous rotation;

[0036] 5) The bending knob 311 is connected to the distal end of the sheath through a guide wire and a pull ring to achieve bidirectional bending adjustment.

[0037] Before atrial defibrillation ablation begins, the drive button 312 is adjusted to retract the annular adjustable catheter 34 into the sheath 32. The sheath 32 of the ablation catheter 3 passes through the delivery sheath and enters the left atrium after a transseptal puncture. The distal end of the sheath 32 is exposed from the delivery sheath. The annular adjustable catheter 34 and the annular electrode 35 thereon protrude from the soft double-hole plug 33 under the push of the drive button 312. The specific embodiment is as follows:

[0038] 1) If Figure 5 and Figure 6 As shown, the annular adjustable catheter 34 and the annular electrode 35 thereon expose the soft double-hole plug 33 under the push of the driving push button 312, and expand into a ring. According to the diameter of the expansion adjusted by the driving push button 312, it is pressed against the inner surface of the atrium, and electric pulse ablation is started to produce the required ablation area (meridian position) on the inner surface of the atrium; the position of the handle 31 and the sheath 32 remains unchanged, and the rotation knob 314 is adjusted to drive the rotation of the soft double-hole plug 33 by rotating the driving guide wire 39, so that the annular adjustable catheter 34 is rotated to different angles, and the driving push button 312 is adjusted to adjust the diameter of the expanded annular adjustable catheter 34 to press against the surface of the atrium, and ablation is started. The operation is repeated multiple times, and a variety of rotation angles are selected according to the actual situation of the patient;

[0039] 2) If Figure 7 and Figure 8 As shown, the depth of the handle 31 and the sheath 32 entering the atrium is adjusted, the bending angle of the distal end of the sheath 32 is adjusted by adjusting the bending knob 311, and the driving push button 312 is adjusted to push the annular adjustable catheter 34 into a ring shape to fit the latitude position of the atrium, and ablation is started. The depth of the handle 31 and the sheath 32 entering the atrium, the handle 31 is rotated, and the bending knob 311 is adjusted to achieve ablation in the latitude direction of the entire inner surface of the atrium;

[0040] 3) In summary of the above operations, adjustment and ablation in any direction can be achieved by adjusting the rotating knob 314 and the bending knob 311, forming a maze-like ablation area inside the atrium.

[0041] In another embodiment, the annular adjustable catheter 34 can be a non-closed ring, and the corresponding soft plug is a single hole. When not ablated, the annular adjustable catheter 34 is retracted into the sheath 32 under the adjustment of the driving button 312. During ablation, the driving button 312 pushes the annular adjustable catheter 34 out. The supporting guide wire 36 inside the annular adjustable catheter 34 is a memory alloy wire such as nickel-titanium wire that is pre-shaped into an annular or elliptical shape. Under the joint adjustment of the rotating knob 314 and the bending knob 311, adjustment and ablation in any direction can be achieved, forming a maze-like ablation area inside the atrium. See the schematic diagram for details. Figure 9 .

[0042] The above description is only a preferred embodiment of the present invention and does not limit the present invention in any form or substance. It should be pointed out that ordinary technicians in this technical field can make several improvements and supplements without departing from the present invention, and these improvements and supplements should also be regarded as the scope of protection of the present invention. Any equivalent changes, modifications and evolutions made by technicians familiar with this profession without departing from the spirit and scope of the present invention by using the technical content disclosed above are all equivalent embodiments of the present invention; at the same time, any equivalent changes, modifications and evolutions made to the above embodiments based on the essential technology of the present invention are still within the scope of the technical solution of the present invention.

Claims

1. An atrial maze pulsed electric field ablation catheter, characterized by: The device comprises a handle, a sheath, a plug, an annular adjustable catheter, a support guide wire, an annular electrode and an insulated wire; the handle is provided with a sheath, and the end of the sheath away from the operator is provided with a plug; the annular adjustable catheter is passed through the plug, and the annular adjustable catheter is provided with a support guide wire connected to the handle for adjusting the length of the annular adjustable catheter; the annular adjustable catheter is provided with an annular electrode, and the annular electrode is connected to the handle via an insulated wire; The handle is provided with a driving button, which is connected to the supporting guide wire; The outer periphery of the plug is provided with a circular groove for rotating the plug; a rotating knob is provided on the handle, and a driving guide wire is provided between the rotating knob and the plug for connecting the rotating knob and the plug and rotating synchronously; The handle is provided with a bending knob for adjusting the curvature of the sheath tube; The annular adjustable catheter is provided with a highly elastic, pre-shaped annular support guide wire; A plurality of ring electrodes are provided on the ring-shaped adjustable catheter; The plug is configured as a soft double-hole plug with two through holes, one of the two through holes is fixedly connected to one end of the annular adjustable conduit, and the other hole is passed through the other end of the annular adjustable conduit; a sealing member is provided between the through hole and the annular adjustable conduit; or The plug is a soft single-hole plug with a through hole, one movable end of an annular adjustable conduit is passed through the through hole, the other end of the annular adjustable conduit is set as a closed end, and a seal is provided between the through hole and the annular adjustable conduit.

2. The atrial maze pulsed electric field ablation catheter according to claim 1, characterized in that: An electric connector is provided on the handle, and an insulated wire is provided between the electric connector and the ring electrode.

3. An atrial maze pulsed electric field ablation catheter ablation device according to any one of claims 1 to 2, characterized in that: It also includes a high-voltage pulse generator and a control module; the control module is connected to the ablation catheter through the high-voltage pulse generator.

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