Electrophysiology sheath, electrophysiology catheter, and electrophysiology system

By designing a rotatable connection between the electrophysiological sheath and the catheter handle, the problem of entanglement between the electrophysiological sheath and the catheter is solved, simplifying the untangling operation, shortening the operation time, and reducing the risk.

CN122229461APending Publication Date: 2026-06-19SHENZHEN MINDRAY BIO MEDICAL ELECTRONICS CO LTD +1

Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
SHENZHEN MINDRAY BIO MEDICAL ELECTRONICS CO LTD
Filing Date
2025-12-30
Publication Date
2026-06-19

AI Technical Summary

Technical Problem

Existing electrophysiological sheaths and catheters are prone to entanglement during operation, making the procedure cumbersome, time-consuming, affecting the smoothness of the operation and increasing the risk.

Method used

The handles of the electrophysiological sheath and catheter are designed to be rotatable, allowing the cable to remain electrically connected during rotation by rotating the tail end, thus simplifying the untangling process.

Benefits of technology

It enables rapid untangling, shortens operation time, reduces surgical risks, and improves surgical efficiency.

✦ Generated by Eureka AI based on patent content.

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Abstract

This invention relates to the field of medical devices and discloses an electrophysiological sheath, an electrophysiological catheter, and an electrophysiological system. The electrophysiological sheath includes a first tube body, a first position detection device, a first handle, and a first cable. The first tube body has a first distal end and a first proximal end. The first position detection device is located at the first distal end. The first handle includes a first bending portion and a first tail end. The first bending portion is electrically connected to the first position detection device and is used to control the bending of the first distal end. The first tail end is rotatably connected to the first bending portion, and the first tail end and the first bending portion maintain electrical connection during relative rotation. One end of the first cable is electrically connected to the first tail end, and the other end of the first cable is used for electrical connection to the electrophysiological device. This invention simplifies the untangling operation of the first cable.
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Description

Technical Field

[0001] This invention relates to the field of medical devices, and more particularly to an electrophysiological sheath, an electrophysiological catheter, and an electrophysiological system having the electrophysiological sheath and / or the electrophysiological catheter. Background Technology

[0002] The related technology provides an electrophysiological system that uses an electrophysiological sheath to construct a guiding channel for the electrophysiological catheter from outside the patient's body to inside the patient's body. The sheath's handle has a first cable (first tail cable) for connecting to a mapping system at its tail end. The electrophysiological catheter's handle also has a second cable (second tail cable) for connecting to the mapping system and / or an ablation device. In practical applications, the user needs to adjust the bending angle of the electrophysiological sheath using its handle to achieve stable support (e.g., against a pulmonary vein), while simultaneously rotating the internal electrophysiological catheter for precise positioning.

[0003] The electrophysiological sheaths provided by the aforementioned technologies have the following shortcomings in practical applications: When the electrophysiological sheath is used in combination with the internal electrophysiological catheter, the first tail wire of the electrophysiological sheath is prone to entanglement with the electrophysiological catheter. This entanglement restricts the axial movement and rotational freedom of the electrophysiological catheter within the electrophysiological sheath, forcing the surgeon to interrupt the procedure to untangle it. Since the first tail wire and the entire handle of the electrophysiological sheath are relatively fixed, the only way to untangle it is by gradually rotating the electrophysiological catheter in the opposite direction. Each untangling operation takes an average of 3 to 5 minutes. The untangling process is cumbersome and time-consuming, and at least 5 to 10 untangling operations are required in atrial fibrillation ablation surgery. The cumulative untangling operations can extend the operation time by 5% to -10% or more, seriously affecting the smoothness of the operation and increasing the risk of complications. In addition, excessive traction on the tail filament of the electrophysiological sheath can easily damage the filament, resulting in distortion of the visualization image of the electrophysiological sheath. For example, the bend shape of the electrophysiological sheath displayed by the mapping system may not match the actual shape, thereby increasing the risk of surgery.

[0004] The electrophysiological catheters provided by the aforementioned technologies have the following shortcomings in practical applications: During the process of rotating the electrophysiological catheter for positioning, the second tail wire at the end of the handle of the electrophysiological catheter is prone to self-entanglement. When the second tail wire contains a large number of thick wires, the self-entanglement of the second tail wire will increase the difficulty of rotating and positioning the electrophysiological catheter. Summary of the Invention

[0005] The first objective of this invention is to provide an electrophysiological sheath that solves the technical problem in the related art where the cable at the tail of the electrophysiological sheath and the electrophysiological catheter are easily entangled, and the untangling operation is cumbersome and time-consuming.

[0006] To achieve the above objectives, the present invention provides an electrophysiological sheath, at least for constructing a guiding channel from outside the patient to inside the patient for an electrophysiological catheter independent of the electrophysiological sheath and used for mapping and / or ablation, the electrophysiological sheath comprising: A first tube body, the first tube body having a first distal end and a first proximal end that are spaced apart and opposite to each other, the first distal end being used for insertion into the patient's body; A first position detection device is disposed at the first far end to obtain position information of the first far end; A first handle, comprising a first bending portion and a first tail portion, wherein the first bending portion is connected to or integrally formed with the first proximal end, and the first bending portion is electrically connected to the first position detection device, and the first bending portion is used to control the bending of the first distal end; the first tail portion is disposed on the side of the first bending portion away from the first distal end, the first tail portion is rotatably connected to the first bending portion, and the first tail portion and the first bending portion maintain electrical connection during relative rotation. A first cable, one end of which is electrically connected to the first tail, and the other end of which is used to be electrically connected to an electrophysiological device independent of the electrophysiological sheath; An axial through hole is formed inside the electrophysiological sheath, which sequentially passes through the first tail section, the first bending section, and the first tube body to form a guide channel for the electrophysiological catheter to pass through.

[0007] A second object of the present invention is to provide an electrophysiological catheter for mapping and / or ablation, the electrophysiological catheter comprising: The second tube has a second distal end and a second proximal end that are spaced apart and opposite to each other. The second distal end is used to be inserted into the patient's body. The second distal end is provided with a second position detection device to obtain the position information of the second distal end. The second handle includes a second bending portion and a second tail portion. The second bending portion is connected to or integrally formed with the second proximal end, and is electrically connected to the second position detection device and / or the ablation energy output device. The second bending portion is used to control the bending of the second distal end. The second tail portion is located on the side of the second bending portion away from the second distal end. The second tail portion is rotatably connected to the second bending portion, and the second tail portion and the second bending portion maintain electrical connection during relative rotation. A second cable, one end of which is electrically connected to the second tail, and the other end of which is used for electrical connection to an electrophysiological device independent of the electrophysiological catheter.

[0008] A third objective of this invention is to provide an electrophysiological system comprising: At least one electrophysiological device; At least one of the above-mentioned electrophysiological sheaths and / or at least one of the above-mentioned electrophysiological catheters; Wherein, at least one electrophysiological sheath is electrically connected to one of the electrophysiological devices via the first cable, for transmitting the location information of the first distal end to one of the electrophysiological devices; The at least one electrophysiological catheter is electrically connected to the at least one electrophysiological device via the second cable for mapping and / or ablation. The electrophysiological sheath provided by the first objective of this invention comprises a first handle consisting of a first bending section and a first tail section, with the first tail section and the first bending section designed to be rotatably electrically connected. One end of a first cable for electrical connection with the electrophysiological equipment is connected to the first tail section, allowing the first cable to rotate relative to the first bending section with the first tail section. In practical applications, when the first cable becomes entangled with the electrophysiological catheter inserted within the electrophysiological sheath, the surgical operator can quickly untangle the cable by rotating the first tail section without interrupting the surgery. The untangling operation is simple and quick, reducing the duration of the surgery and thus lowering the surgical risk.

[0009] The second objective of this invention provides an electrophysiological catheter that comprises a second handle consisting of a second bend and a second tail. The second tail and the second bend are designed to be rotatably electrically connected. One end of a second cable, used for electrical connection to the electrophysiological device, is connected to the second tail, allowing the cable to rotate relative to the second bend. In practical applications, when the second cable becomes entangled, the surgeon can quickly untangle it by rotating the second tail without interrupting the surgery. This untangling method is simple and quick, reducing surgical time and thus minimizing surgical risks.

[0010] The electrophysiological system provided by the third objective of this invention, by employing the aforementioned electrophysiological sheath and / or electrophysiological catheter, makes the untangling operation of at least one of the electrophysiological sheath and electrophysiological catheter very simple and quick, thus shortening the operation time and reducing the risk of surgery. Attached Figure Description

[0011] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the structures shown in these drawings without creative effort.

[0012] Figure 1 This is a three-dimensional schematic diagram of an electrophysiological sheath and electrophysiological catheter provided in an embodiment of the present invention; Figure 2 yes Figure 1 A exploded view of the electrophysiological sheath in a diagram. Figure 3 yes Figure 1 A schematic diagram of the electrophysiological sheath from another perspective; Figure 4 yes Figure 1 Another exploded diagram of the electrophysiological sheath in the image; Figure 5 yes Figure 1 A cross-sectional schematic diagram of the electrophysiological sheath in the middle; Figure 6 yes Figure 2 A schematic diagram showing the distribution of the first elastic conductive element on the first circuit board; Figure 7 yes Figure 3 A schematic diagram showing the distribution of the first conductive slip ring on the second circuit board; Figure 8 This is a three-dimensional schematic diagram of an electrophysiological sheath provided in another embodiment of the present invention; Figure 9 yes Figure 8 A exploded view of the electrophysiological sheath in a diagram. Figure 10 yes Figure 8 A schematic diagram of the electrophysiological sheath from another perspective; Figure 11 This is an exploded view of an electrophysiological catheter provided in an embodiment of the present invention; Figure 12 yes Figure 11 A breakdown diagram of the electrophysiological catheter from another perspective.

[0013] Reference numerals in the attached figures: 100, Electrophysiological sheath; 110, First tube body; 120, First handle; 121, First bending section; 1211, Annular flange; 122, First tail; 1221, Annular groove; 130, First cable; 140, First conductive slip ring; 150, First elastic conductive element; 151, Electrical connection; 152, Fixing part; 160, First circuit board; 161, First through hole; 170, Second circuit board; 171, Second through hole; 180, First locking component; 190, First fastener; 101, Axial through hole; 200, Electrophysiological catheter; 210, Second tube body; 220, Second handle; 221, Second bending section; 222, Second tail; 230, Second cable; 240, Second conductive slip ring; 250, Second elastic conductive element; 260, Third circuit board; 270, Fourth circuit board. Detailed Implementation

[0014] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0015] The embodiments of the present invention are applicable to electrophysiological scenarios in which an electrophysiological sheath is used as a guide channel for an electrophysiological catheter, and are particularly applicable to cardiac electrophysiological scenarios in which an electrophysiological sheath is used as a guide channel for an electrophysiological catheter to perform cardiac mapping and / or cardiac ablation.

[0016] like Figures 1 to 12As shown, a first aspect of the present invention provides an electrophysiological sheath 100, which is at least used to construct a guide channel from outside the patient's body to inside the patient's body for an electrophysiological catheter 200, which is independent of the electrophysiological sheath 100 and is used for mapping and / or ablation. The electrophysiological sheath 100 includes a first tube body 110, a first position detection device, a first handle 120, and a first cable 130. The first tube body 110 has a first distal end and a first proximal end disposed at a distance from each other, the first distal end being used for insertion into the patient's body. The first position detection device is disposed at the first distal end for acquiring position information of the first distal end. The first handle 120 includes a first bending portion 121 and a first tail portion 122. The first bending portion 121 is connected to or integrally formed with the first proximal end, and the first bending portion 121 is electrically connected to the first position detection device, the first bending portion 121 being used to control the bending of the first distal end. The first tail portion 122 is located on the side of the first bending portion 121 away from the first distal end. The first tail portion 122 and the first bending portion 121 are rotatably connected, and the first tail portion 122 and the first bending portion 121 maintain electrical connection during relative rotation. One end of the first cable 130 is electrically connected to the first tail portion 122, and the other end of the first cable 130 is used for electrical connection to an electrophysiological device independent of the electrophysiological sheath 100. An axial through hole 101 is formed inside the electrophysiological sheath 100, which sequentially passes through the first tail portion 122, the first bending portion 121, and the first tube body 110 to form a guide channel for the insertion of the electrophysiological catheter 200. The first cable 130 is the tail wire of the electrophysiological sheath 100. This implementation scheme divides the first handle 120 of the electrophysiological sheath 100 into two parts: a first bending section 121 and a first tail section 122. The first tail section 122 and the first bending section 121 are designed to be rotatably electrically connected. One end of the first cable 130, which is used to electrically connect to the electrophysiological equipment, is connected to the first tail section 122, so that the first cable 130 can rotate relative to the first bending section 121 with the first tail section 122. In practical applications, when the first cable 130 becomes entangled with the electrophysiological catheter 200 inserted in the electrophysiological sheath 100, the surgical operator can quickly untangle the first cable 130 from the electrophysiological catheter 200 by rotating the first tail section 122 without interrupting the surgery. The untangling operation is simple and quick, which helps to shorten the operation time and thus reduce the risk of surgery.

[0017] In one embodiment, one of the first bending portion 121 and the first tail portion 122 is provided with a first conductive slip ring 140, and the other is provided with a first elastic conductive element 150. The first tail portion 122 and the first bending portion 121 are electrically connected through the contact between the first elastic conductive element 150 and the first conductive slip ring 140. One of the first conductive slip ring 140 and the first elastic conductive element 150 is fixedly connected to the first bending portion 121, and the other is fixedly connected to the first tail portion 122. That is, one of the first conductive slip ring 140 and the first elastic conductive element 150 is fixedly disposed relative to the first bending portion 121, and the other is fixedly disposed relative to the first tail portion 122. In this way, when the first bending portion 121 and the first tail portion 122 rotate relative to each other, the first conductive slip ring 140 and the first elastic conductive element 150 also rotate relative to each other. The annular structure of the first conductive slip ring 140 ensures that the first elastic conductive element 150 remains in contact with the first conductive slip ring 140 during relative rotation between the first conductive slip ring 140 and the first elastic conductive element 150. This guarantees that the first elastic conductive element 150 and the first conductive slip ring 140 maintain electrical connection during relative rotation between the first tail portion 122 and the first bending portion 121, thereby facilitating the reliability of the electrical connection between the first position detection device and the first cable 130. The elastic performance of the first elastic conductive element 150 ensures reliable contact between the first elastic conductive element 150 and the first conductive slip ring 140 through its elastic force, and also allows the first elastic conductive element 150 and the first conductive slip ring 140 to rotate relative to each other under external force through its elastic deformation capability.

[0018] In one embodiment, the first elastic conductive element 150 is disposed on the first bending portion 121, and the first conductive slip ring 140 is disposed on the first tail portion 122. Of course, in specific applications, as an alternative embodiment, the first elastic conductive element 150 may be disposed on the first tail portion 122, and the first conductive slip ring 140 may be disposed on the first bending portion 121.

[0019] In one embodiment, the first bending section 121 is provided with a first circuit board 160, and the first tail section 122 is provided with a second circuit board 170. One of the first circuit board 160 and the second circuit board 170 is provided with a first conductive slip ring 140, and the other is provided with a first elastic conductive element 150. The first position detection device is electrically connected to the first circuit board 160; the first cable 130 is electrically connected to the second circuit board 170. The first circuit board 160 and the second circuit board 170 are spaced apart along the axial direction of the electrophysiological sheath 100. The first conductive slip ring 140 and the first elastic conductive element 150 are respectively provided on two facing panels of the first circuit board 160 and the second circuit board 170. This embodiment realizes the installation of the first elastic conductive element 150 and the first conductive slip ring 140, and the electrical connection between the first position detection device and the first cable 130 through the first circuit board 160 and the second circuit board 170.

[0020] In one embodiment, the first elastic conductive member 150 has an electrical connection portion 151 for cooperating with the first conductive slip ring 140. The electrical connection portion 151 has a circumferentially symmetrical structure in the electrophysiological sheath 100. This facilitates smooth rotation of the first elastic conductive member 150 and the first conductive slip ring 140 relative to each other, both counterclockwise and clockwise.

[0021] In one implementation, the first elastic conductive element 150 is a metal spring sheet, which can be manufactured by stamping, facilitating mass production and reducing manufacturing costs. Of course, in specific applications, as an alternative implementation, the first elastic conductive element 150 can also be a metal needle or other elastic conductive element.

[0022] In one embodiment, the metal spring includes a fixing part 152 and two electrical connection parts 151. The fixing part 152 is used to connect to the first circuit board 160, and the two electrical connection parts 151 are symmetrically arranged at both ends of the fixing part 152 along the circumference of the electrophysiological sheath 100.

[0023] In one embodiment, the fixing part 152 is attached to the first circuit board 160, and the two electrical connection parts 151 are bent and extended from both ends of the fixing part 152 to a position with a certain distance from the first circuit board 160, so that the two electrical connection parts 151 have a certain elastic deformation space.

[0024] In one embodiment, the middle position of the first circuit board 160 is provided through the first through hole 161, and the middle position of the second circuit board 170 is provided through the second through hole 171. The first through hole 161 and the second through hole 171 are used for the power supply physiological catheter 200 to pass through the first circuit board 160 and the second circuit board 170.

[0025] In one implementation, the first circuit board 160 is connected to the first bending part 121 by a first screw, and the second circuit board 170 is connected to the first tail part 122 by a second screw. The installation method is simple and the fastening is reliable.

[0026] In one implementation, the number of first conductive slip rings 140 and first elastic conductive elements 150 is at least two. At least two first conductive slip rings 140 are arranged radially spaced along the electrophysiological sheath 100, meaning at least two first conductive slip rings 140 are concentric rings with different diameters. At least two first elastic conductive elements 150 are arranged radially spaced along the electrophysiological sheath 100, and each first conductive slip ring 140 is electrically connected to at least one first elastic conductive element 150, i.e., at least two first elastic conductive elements 150 are distributed on concentric rings of different diameters and aligned with at least two first conductive slip rings 140. In this embodiment, setting the number of first conductive slip rings 140 and first elastic conductive elements 150 to at least two facilitates the formation of an electrical connection circuit. Distributing at least two first conductive slip rings 140 radially spaced along the electrophysiological sheath 100 facilitates the placement of all first conductive slip rings 140 on one end face, which is beneficial for circuit design and manufacturing.

[0027] Of course, in specific applications, the at least two first conductive slip rings 140 are not limited to being distributed radially. For example, as an alternative implementation, the number of both the first conductive slip rings 140 and the first elastic conductive elements 150 is at least two, with at least two first conductive slip rings 140 spaced apart along the axial direction of the electrophysiological sheath 100, and at least two first elastic conductive elements 150 spaced apart along the axial direction of the electrophysiological sheath 100. Each first conductive slip ring 140 is electrically connected to at least one first elastic conductive element 150. The axial direction of the electrophysiological sheath 100 is the length direction of the electrophysiological sheath 100. In this embodiment, the at least two first conductive slip rings 140 are spaced apart along the axial direction of the electrophysiological sheath 100, which also facilitates the separate electrical connection of at least two first conductive slip rings 140 to at least two first elastic conductive elements 150.

[0028] In one implementation, the number of first elastic conductive elements 150 is greater than the number of first conductive slip rings 140, and at least two first elastic conductive elements 150 are arranged at circumferential intervals along the electrophysiological sheath 100 and electrically connected to the same first conductive slip ring 140. In this embodiment, one first conductive slip ring 140 is in contact with at least two first elastic conductive elements 150 simultaneously, which helps to ensure the reliability of the conductive connection between the first conductive slip ring 140 and the first elastic conductive elements 150.

[0029] In a first embodiment of locking and positioning the first bending portion 121 and the first tail portion 122, the first bending portion 121 and the first tail portion 122 are prevented from rotating relative to each other by the frictional force between the first conductive slip ring 140 and the first elastic conductive member 150. However, when an external force overcomes the frictional force between the first conductive slip ring 140 and the first elastic conductive member 150, relative rotation between the first tail portion 122 and the first bending portion 121 is permitted. In this embodiment, the frictional force between the first conductive slip ring 140 and the first elastic conductive member 150 prevents arbitrary relative rotation between the first tail portion 122 and the first bending portion 121 without the need for additional components to lock them. This structure is simple and easy to implement.

[0030] In a second embodiment of locking and positioning the first bending portion 121 and the first tail portion 122, the electrophysiological sheath 100 further includes a first locking member 180, which has a first assembly state and a second assembly state. In the first assembly state, the first locking member 180 locks the first tail portion 122 and the first bending portion 121 to prevent relative rotation between them. In the second assembly state, the first locking member 180 releases the first tail portion 122 and the first bending portion 121 to allow relative rotation between them. This embodiment, by adding the first locking member 180 to lock the first tail portion 122 and the first bending portion 121, improves the reliability of the positioning of the first tail portion 122 and the first bending portion 121.

[0031] As a further embodiment of the second implementation of the locking and positioning of the first bending portion 121 and the first tail portion 122, the first bending portion 121 or the first tube body 110 has a first connecting tube rotatably inserted into the first tail portion 122; the electrophysiological sheath 100 also includes a first fastener 190, which is connected to the end of the first connecting tube away from the first bending portion 121 and engages with the first tail portion 122 to prevent the first connecting tube from slipping off the first tail portion 122; in the first assembled state, the first locking member 180 extends from the outer side wall of the first tail portion 122 and abuts against the outer side wall of the portion of the first connecting tube located inside the first tail portion 122; in the second assembled state, the first locking member 180 disengages from the first connecting tube. In this embodiment, the first fastener 190 axially limits the first connecting tube, which helps to ensure the stable and reliable installation of the first connecting tube.

[0032] As a further embodiment of the second implementation of the locking and positioning of the first bending portion 121 and the first tail portion 122, the first locking member 180 is a screw threadedly connected to the first tail portion 122. In specific applications, the locking of the first tail portion 122 and the first bending portion 121, as well as the loosening of the first tail portion 122 and the first bending portion 121, can be achieved by screwing the first locking member 180 in and out. The locking and loosening operation is simple and easy to implement.

[0033] In a further embodiment of the second locking and positioning method of the first bending portion 121 and the first tail portion 122, the end of the first connecting tube away from the first bending portion 121 is located inside the first tail portion 122, and the first fastener 190 is a screw that is threaded to the first connecting tube and engages with the first tail portion 122. The first fastener 190 has a third through hole through which the power supply physiological catheter 200 passes axially. Alternatively, as an alternative embodiment, the end of the first connecting tube away from the first bending portion 121 is located inside the first tail portion 122, and the first fastener 190 is a retaining ring installed on the first connecting tube and engaging with the first tail portion 122; the retaining ring is a retaining spring.

[0034] In one implementation, the electrophysiological sheath 100 further includes a first wireless signal transmission device, which is disposed within the first tail portion 122 for transmitting first distal location information to the electrophysiological device. In this embodiment, the first distal location information can be transmitted to the electrophysiological device via either the first cable 130 or the first wireless signal transmission device. Of course, in specific applications, as an alternative implementation, the electrophysiological sheath 100 may only have one of the first cable 130 and the first wireless signal transmission device; that is, the electrophysiological sheath 100 may include the first cable 130 but not the first wireless signal transmission device; or the electrophysiological sheath 100 may include the first wireless signal transmission device but not the first cable 130.

[0035] In one implementation, the first position detection device includes a first magnetic coil and / or a first electrode. That is, the first position detection device can use a magnetic coil for position detection, or it can use an electrode for position detection, or it can use both a magnetic coil and an electrode for position detection.

[0036] In one embodiment, one end of the first bending portion 121 and the first tail portion 122 is fitted inside one end of the other and can be rotatably connected.

[0037] In one embodiment, one end of the first bending portion 121 and the first tail portion 122 has an annular groove 1221 on its outer side wall, and the other end has an annular flange 1211 protruding inward. The first bending portion 121 and the first tail portion 122 are rotatably connected by the snap-fit ​​of the annular flange 1211 and the annular groove 1221.

[0038] In one implementation, an annular groove 1221 is formed on the first tail portion 122, and an annular flange 1211 is formed on the first bending portion 121. Of course, in specific applications, as an alternative implementation, the annular flange 1211 may be formed on the first tail portion 122, and the annular groove 1221 may be formed on the first bending portion 121.

[0039] A second aspect of this invention provides an electrophysiological catheter 200 for mapping and / or ablation. The electrophysiological catheter 200 includes a second tube body 210, a second handle 220, and a second cable 230. The second tube body 210 has a second distal end and a second proximal end spaced apart and opposite to each other. The second distal end is inserted into a patient's body and is equipped with a second position detection device to acquire position information of the second distal end. The second handle 220 includes a second bending portion 221 and a second tail portion 222. The second bending portion 221 is connected to or integrally formed with the second proximal end and is electrically connected to the second position detection device and / or an ablation energy output device. The second bending portion 221 is used to control the bending of the second distal end. The second tail portion 222 is located on the side of the second bending portion 221 away from the second distal end. The second tail portion 222 is rotatably connected to the second bending portion 221 and maintains electrical connection with the second bending portion 221 during relative rotation. One end of the second cable 230 is electrically connected to the second tail 222, and the other end of the second cable 230 is used for electrical connection to an electrophysiological device independent of the electrophysiological catheter 200. This embodiment configures the second handle 220 of the electrophysiological catheter 200 as comprising a second bending section 221 and a second tail 222, and designs the second tail 222 and the second bending section 221 as rotatably electrically connected. One end of the second cable 230, used for electrical connection to the electrophysiological device, is connected to the second tail 222, allowing the second cable 230 to rotate relative to the second bending section 221 with the second tail 222. Thus, in practical applications, when the second cable 230 becomes entangled, the surgical operator can quickly untangle the second cable 230 by rotating the second tail 222 without interrupting the surgery. The untangling operation of the electrophysiological catheter 200 provided by this embodiment is simple and quick, which helps to shorten the operation time and thus reduce the surgical risk. In one embodiment, one of the second bending portion 221 and the second tail portion 222 is provided with a second conductive slip ring 240, and the other is provided with a second elastic conductive element 250. The second tail portion 222 and the second bending portion 221 are electrically connected through the contact between the second elastic conductive element 250 and the second conductive slip ring 240. The setting principle and implementation method of the second conductive slip ring 240 and the second elastic conductive element 250 are similar to the setting principle and implementation method of the first conductive slip ring 140 and the first elastic conductive element 150 described above, and will not be described in detail here.

[0040] In one embodiment, the number of second conductive slip rings 240 and second elastic conductive elements 250 is at least two. At least two second conductive slip rings 240 are arranged radially spaced along the electrophysiological catheter 200, and at least two second elastic conductive elements 250 are arranged radially spaced along the electrophysiological catheter 200. Each second conductive slip ring 240 is electrically connected to at least one second elastic conductive element 250. Alternatively, the number of second conductive slip rings 240 and second elastic conductive elements 250 is at least two. At least two second conductive slip rings 240 are arranged axially spaced along the electrophysiological catheter 200, and at least two second elastic conductive elements 250 are arranged axially spaced along the electrophysiological catheter 200. Each second conductive slip ring 240 is electrically connected to at least one second elastic conductive element 250.

[0041] In one implementation, the number of second elastic conductive elements 250 is greater than the number of second conductive slip rings 240, and at least two second elastic conductive elements 250 are arranged at circumferential intervals along the electrophysiological catheter 200 and electrically connected to the same second conductive slip ring 240. In one implementation, the second bending section 221 is provided with a third circuit board 260, and the second tail section 222 is provided with a fourth circuit board 270. One of the third circuit board 260 and the fourth circuit board 270 is provided with a second conductive slip ring 240, and the other is provided with a second elastic conductive element 250. The second position detection device is electrically connected to the third circuit board 260, and the second cable 230 is electrically connected to the fourth circuit board 270. The setting principle and implementation method of the third circuit board 260 and the fourth circuit board 270 are similar to those of the first circuit board 160 and the second circuit board 170 described above, and will not be described in detail here. In a first embodiment of locking and positioning the second bending portion 221 and the second tail portion 222, the second bending portion 221 and the second tail portion 222 are prevented from rotating relative to each other by the frictional force between the second conductive slip ring 240 and the second elastic conductive member 250; and when an external force overcomes the frictional force between the second conductive slip ring 240 and the second elastic conductive member 250, the second tail portion 222 and the second bending portion 221 are allowed to rotate relative to each other.

[0042] As a second embodiment of locking and positioning the second bend 221 and the second tail 222, the electrophysiological catheter 200 further includes a second locking component, which has a third assembly state and a fourth assembly state. In the third assembly state, the second locking component locks the second tail 222 and the second bend 221 to prevent relative rotation between the second tail 222 and the second bend 221. In the fourth assembly state, the second locking component releases the second tail 222 and the second bend 221 to allow relative rotation between the second tail 222 and the second bend 221. The setting principle and implementation method of the second locking component are similar to those of the first locking component 180 described above, and will not be detailed here.

[0043] As a further embodiment of the second embodiment of locking and positioning the second bending portion 221 and the second tail portion 222, the second bending portion 221 or the second tube body 210 has a second connecting tube that can be rotatably inserted into the second tail portion 222; the electrophysiological catheter 200 also includes a second fastener, which is connected to the end of the second connecting tube away from the second bending portion 221 and engages with the second tail portion 222 to prevent the second connecting tube from slipping off the second tail portion 222; in the third assembly state, the second locking member extends from the outer side wall of the second tail portion 222 and abuts against the outer side wall of the portion of the second connecting tube located inside the second tail portion 222; in the fourth assembly state, the second locking member disengages from the second connecting tube.

[0044] As a further embodiment of the second embodiment of locking and positioning the second bending part 221 and the second tail part 222, the second locking member is a screw that is threadedly connected to the second tail part 222.

[0045] As a further embodiment of the second embodiment for locking and positioning the second bending portion 221 and the second tail portion 222, the end of the second connecting tube away from the second bending portion 221 is located inside the second tail portion 222, and the second fastener is a screw that is threaded to the second connecting tube and engages with the second tail portion 222; or, the end of the second connecting tube away from the second bending portion 221 is located inside the second tail portion 222, and the second fastener is a retaining ring that is installed on the second connecting tube and engages with the second tail portion 222.

[0046] In one implementation, the electrophysiological catheter 200 further includes a second wireless signal transmission device, which is disposed within the second tail portion 222 for transmitting the location information of the second distal end to the electrophysiological device. The principle and implementation of the second wireless signal transmission device are similar to those of the first wireless signal transmission device described above, and will not be detailed here.

[0047] In one implementation, the second position detection device includes a second magnetic coil and / or a second electrode.

[0048] A third aspect of this invention provides an electrophysiological system comprising at least one electrophysiological device, at least one electrophysiological sheath 100 and / or at least one electrophysiological catheter 200; wherein at least one electrophysiological sheath 100 is electrically connected to an electrophysiological device via a first cable 130 for transmitting first distal location information to the electrophysiological device; and at least one electrophysiological catheter 200 is electrically connected to at least one electrophysiological device via a second cable 230 for mapping and / or ablation. The electrophysiological system provided in this embodiment, by employing the aforementioned electrophysiological sheath 100 and / or electrophysiological catheter 200, simplifies the untangling operation of at least one of the electrophysiological sheath 100 and electrophysiological catheter 200, reducing operation time and thus shortening surgical duration and risk. In one implementation, at least one electrophysiological device includes a mapping system. The electrophysiological system includes at least one electrophysiological sheath 100 and at least one electrophysiological catheter 200, with the at least one electrophysiological sheath 100 electrically connected to the mapping system. The at least one electrophysiological catheter 200 is a mapping catheter, electrically connected to the mapping system, and is used to penetrate from outside the patient's body into the patient's body through a guiding channel formed by the at least one electrophysiological sheath 100 for mapping. In this embodiment, the electrophysiological device is a mapping system. The mapping system can combine the spatial position of the mapping catheter with electrical signals to construct a three-dimensional geometric model of the heart.

[0049] Alternatively, as another implementation, at least one electrophysiological device includes an ablation device, and the electrophysiological system includes at least one electrophysiological catheter 200, which is an ablation catheter electrically connected to the ablation device. The ablation device is used to perform ablation treatment on the patient through the ablation catheter. The ablation device is one of the key devices in cardiac electrophysiological interventional surgery, and it is mainly used to deliver ablation energy, such as radiofrequency ablation energy or pulsed ablation energy, to the ablation catheter to perform ablation treatment on the lesion site.

[0050] Alternatively, as another implementation, at least one electrophysiological device includes an ablation device and a mapping system. The electrophysiological system includes at least one electrophysiological sheath 100 and at least two electrophysiological catheters 200. The at least two electrophysiological catheters 200 include at least one mapping catheter and at least one ablation catheter. The electrophysiological sheath 100, the at least one mapping catheter, and the at least one ablation catheter are all electrically connected to the mapping system. The at least one mapping catheter and the at least one ablation catheter are used to penetrate from outside the patient's body into the patient's body through the guiding channel formed by the at least one electrophysiological sheath 100. The mapping catheter is used for mapping. The at least one ablation catheter is also electrically connected to the ablation device, which is used to perform ablation treatment on the patient through the ablation catheter.

[0051] Alternatively, in yet another implementation, at least one electrophysiological device includes a control platform integrating an interface unit, an ablation unit, and a mapping unit. The electrophysiological system includes at least one electrophysiological sheath 100 and at least two electrophysiological catheters 200. The at least two electrophysiological catheters 200 include at least one mapping catheter and at least one ablation catheter. The electrophysiological sheath 100, the at least one mapping catheter, and the at least one ablation catheter are all electrically connected to the mapping unit via the interface unit. The at least one mapping catheter and the at least one ablation catheter are used to penetrate from outside the patient's body into the patient's body through the guide channel formed by the at least one electrophysiological sheath 100. The mapping catheter is used for mapping. The at least one ablation catheter is also electrically connected to the ablation unit via the interface unit. The ablation unit is used to perform ablation treatment on the patient through the ablation catheter.

[0052] The above description is merely a preferred embodiment of the present invention and does not limit the patent scope of the present invention. Any equivalent structural transformations made using the contents of the present invention's specification and drawings under the inventive concept of the present invention, or direct / indirect applications in other related technical fields, are included within the patent protection scope of the present invention.

Claims

1. An electrophysiological sheath, at least for constructing a guiding channel from outside the patient to inside the patient for an electrophysiological catheter independent of said electrophysiological sheath and used for mapping and / or ablation, characterized in that: The electrophysiological sheath includes: A first tube body, the first tube body having a first distal end and a first proximal end that are spaced apart and opposite to each other, the first distal end being used for insertion into the patient's body; A first position detection device is disposed at the first far end to obtain position information of the first far end; A first handle, comprising a first bending portion and a first tail portion, wherein the first bending portion is connected to or integrally formed with the first proximal end, and the first bending portion is electrically connected to the first position detection device, and the first bending portion is used to control the bending of the first distal end; the first tail portion is disposed on the side of the first bending portion away from the first distal end, the first tail portion is rotatably connected to the first bending portion, and the first tail portion and the first bending portion maintain electrical connection during relative rotation. A first cable, one end of which is electrically connected to the first tail, and the other end of which is used to be electrically connected to an electrophysiological device independent of the electrophysiological sheath; An axial through hole is formed inside the electrophysiological sheath, which sequentially passes through the first tail section, the first bending section, and the first tube body to form a guide channel for the electrophysiological catheter to pass through.

2. The electrophysiological sheath as described in claim 1, characterized in that: One of the first bending section and the first tail section is provided with a first conductive slip ring, and the other is provided with a first elastic conductive element. The first tail section and the first bending section are electrically connected through the contact between the first elastic conductive element and the first conductive slip ring.

3. The electrophysiological sheath as described in claim 2, characterized in that: The number of the first conductive slip ring and the first elastic conductive element is at least two. The at least two first conductive slip rings are arranged radially spaced along the electrophysiological sheath, and the at least two first elastic conductive elements are arranged radially spaced along the electrophysiological sheath. Each first conductive slip ring is electrically connected to at least one first elastic conductive element. Alternatively, the number of the first conductive slip ring and the first elastic conductive element is at least two, the at least two first conductive slip rings are arranged at intervals along the axial direction of the electrophysiological sheath, and the at least two first elastic conductive elements are arranged at intervals along the axial direction of the electrophysiological sheath, with each first conductive slip ring being electrically connected to at least one first elastic conductive element.

4. The electrophysiological sheath as described in claim 3, characterized in that: The number of the first elastic conductive elements is greater than the number of the first conductive slip rings, and at least two of the first elastic conductive elements are arranged at circumferential intervals along the electrophysiological sheath and are electrically connected to the same first conductive slip ring.

5. The electrophysiological sheath as described in claim 2, characterized in that: The first bending section is provided with a first circuit board, and the first tail section is provided with a second circuit board. One of the first circuit board and the second circuit board is provided with the first conductive slip ring, and the other is provided with the first elastic conductive element. The first position detection device is electrically connected to the first circuit board; The first cable is electrically connected to the second circuit board.

6. The electrophysiological sheath as described in claim 2, characterized in that: The first elastic conductive element is a metal spring needle or a metal spring sheet; And / or, the first elastic conductive element has an electrical connection portion for engaging with the first conductive slip ring, the electrical connection portion having a circumferentially symmetrical structure in the electrophysiological sheath.

7. The electrophysiological sheath as described in any one of claims 2 to 6, characterized in that: The first bending section and the first tail section are prevented from rotating relative to each other by the friction between the first conductive slip ring and the first elastic conductive element; Furthermore, when an external force overcomes the friction between the first conductive slip ring and the first elastic conductive element, the first tail portion and the first bending portion are allowed to rotate relative to each other.

8. The electrophysiological sheath as described in any one of claims 1 to 6, characterized in that: The electrophysiological sheath further includes a first locking component, which has a first assembly state and a second assembly state. In the first assembly state, the first locking component locks the first tail and the first bending part to prevent the first tail and the first bending part from rotating relative to each other. In the second assembly state, the first locking component releases the first tail and the first bending part to allow the first tail and the first bending part to rotate relative to each other.

9. The electrophysiological sheath as described in claim 8, characterized in that: The first bending section or the first tube body has a first connecting tube that can be rotatably inserted into the first tail section; The electrophysiological sheath further includes a first fastener, which is connected to the end of the first connecting tube away from the first bending portion and engages with the first tail portion to prevent the first connecting tube from slipping off the first tail portion. In the first assembled state, the first locking member extends from the outer side wall of the first tail portion and abuts against the outer side wall of the portion of the first connecting tube located inside the first tail portion. In the second assembly state, the first locking component is disengaged from the first connecting tube.

10. The electrophysiological sheath as described in claim 9, characterized in that: The first locking component is a screw that is threadedly connected to the first tail portion; And / or, the end of the first connecting pipe away from the first bending portion is located inside the first tail portion, and the first fastener is a screw that is threaded to the first connecting pipe and engages with the first tail portion; or, the end of the first connecting pipe away from the first bending portion is located inside the first tail portion, and the first fastener is a retaining ring that is installed on the first connecting pipe and engages with the first tail portion.

11. The electrophysiological sheath as described in any one of claims 1 to 6, characterized in that: The electrophysiological sheath also includes a first wireless signal transmission device, which is disposed in the first tail portion for transmitting the location information of the first distal end to the electrophysiological device. And / or, the first position detection device includes a first magnetic coil and / or a first electrode.

12. An electrophysiological catheter for mapping and / or ablation, characterized in that: include: The second tube has a second distal end and a second proximal end that are spaced apart and opposite to each other. The second distal end is used to be inserted into the patient's body. The second distal end is provided with a second position detection device to obtain the position information of the second distal end. The second handle includes a second bending portion and a second tail portion. The second bending portion is connected to or integrally formed with the second proximal end, and is electrically connected to the second position detection device and / or the ablation energy output device. The second bending portion is used to control the bending of the second distal end. The second tail portion is located on the side of the second bending portion away from the second distal end. The second tail portion is rotatably connected to the second bending portion, and the second tail portion and the second bending portion maintain electrical connection during relative rotation. A second cable, one end of which is electrically connected to the second tail, and the other end of which is used for electrical connection to an electrophysiological device independent of the electrophysiological catheter.

13. The electrophysiological catheter as described in claim 12, characterized in that: One of the second bending section and the second tail section is provided with a second conductive slip ring, and the other is provided with a second elastic conductive element. The second tail section and the second bending section are electrically connected through the contact between the second elastic conductive element and the second conductive slip ring.

14. The electrophysiological catheter as described in claim 13, characterized in that: The number of the second conductive slip ring and the second elastic conductive element is at least two. The at least two second conductive slip rings are arranged radially spaced along the electrophysiological catheter, and the at least two second elastic conductive elements are arranged radially spaced along the electrophysiological catheter. Each second conductive slip ring is electrically connected to at least one second elastic conductive element. Alternatively, the number of the second conductive slip ring and the second elastic conductive element is at least two, the at least two second conductive slip rings are spaced apart along the axial direction of the electrophysiological catheter, and the at least two second elastic conductive elements are spaced apart along the axial direction of the electrophysiological catheter, each second conductive slip ring being electrically connected to at least one second elastic conductive element.

15. The electrophysiological catheter as described in claim 14, characterized in that: The number of the second elastic conductive elements is greater than the number of the second conductive slip rings, and at least two of the second elastic conductive elements are arranged at circumferential intervals along the electrophysiological catheter and are electrically connected to the same second conductive slip ring; And / or, the second bending section is provided with a third circuit board, the second tail section is provided with a fourth circuit board, one of the third circuit board and the fourth circuit board is provided with a second conductive slip ring, and the other is provided with a second elastic conductive element; the second position detection device is electrically connected to the third circuit board; the second cable is electrically connected to the fourth circuit board.

16. The electrophysiological catheter according to any one of claims 13 to 15, characterized in that: The second bending part and the second tail part are prevented from rotating relative to each other by the friction between the second conductive slip ring and the second elastic conductive element; Furthermore, when an external force overcomes the friction between the second conductive slip ring and the second elastic conductive element, the second tail and the second bending part are allowed to rotate relative to each other.

17. The electrophysiological catheter according to any one of claims 12 to 15, characterized in that: The electrophysiological catheter further includes a second locking component, which has a third assembly state and a fourth assembly state. In the third assembly state, the second locking component locks the second tail and the second bending part to prevent the second tail and the second bending part from rotating relative to each other; In the fourth assembly state, the second locking component releases the second tail and the second bending part to allow the second tail and the second bending part to rotate relative to each other.

18. The electrophysiological catheter as described in claim 17, characterized in that: The second bending section or the second tube body has a second connecting tube that can be rotatably inserted into the second tail section; The electrophysiological catheter further includes a second fastener, which is connected to the end of the second connecting tube away from the second bending portion and engages with the second tail portion to prevent the second connecting tube from slipping off the second tail portion; In the third assembly state, the second locking member extends from the outer side wall of the second tail and abuts against the outer side wall of the portion of the second connecting tube located inside the second tail. In the fourth assembly state, the second locking component is disengaged from the second connecting tube.

19. The electrophysiological catheter as described in claim 18, characterized in that: The second locking component is a screw that is threadedly connected to the second tail portion; And / or, the end of the second connecting pipe away from the second bending portion is located inside the second tail portion, and the second fastener is a screw that is threaded to the second connecting pipe and engages with the second tail portion; or, the end of the second connecting pipe away from the second bending portion is located inside the second tail portion, and the second fastener is a retaining ring that is installed on the second connecting pipe and engages with the second tail portion.

20. The electrophysiological catheter according to any one of claims 12 to 15, characterized in that: The electrophysiological catheter also includes a second wireless signal transmission device, which is disposed in the second tail portion for transmitting the location information of the second distal end to the electrophysiological device. And / or, the second position detection device includes a second magnetic coil and / or a second electrode.

21. An electrophysiological system, characterized in that: include: At least one electrophysiological device; At least one electrophysiological sheath as described in any one of claims 1 to 11 and / or at least one electrophysiological catheter as described in any one of claims 12 to 20; Wherein, at least one electrophysiological sheath is electrically connected to one of the electrophysiological devices via the first cable, for transmitting the location information of the first distal end to one of the electrophysiological devices; The at least one electrophysiological catheter is electrically connected to the at least one electrophysiological device via the second cable for mapping and / or ablation.

22. The electrophysiological system as claimed in claim 21, characterized in that: The at least one electrophysiological device includes a mapping system, the electrophysiological system includes at least one electrophysiological sheath and at least one electrophysiological catheter, and the at least one electrophysiological sheath is electrically connected to the mapping system, the at least one electrophysiological catheter is a mapping catheter, the mapping catheter is electrically connected to the mapping system, and the mapping catheter is used to pass through the guide channel formed by the at least one electrophysiological sheath from outside the patient into the patient's body for mapping; Alternatively, the at least one electrophysiological device includes an ablation device, the electrophysiological system includes at least one electrophysiological catheter, the at least one electrophysiological catheter is an ablation catheter, the ablation catheter is electrically connected to the ablation device, and the ablation device is used to perform ablation treatment on the patient through the ablation catheter; Alternatively, the at least one electrophysiological device includes an ablation device and a mapping system. The electrophysiological system includes at least one electrophysiological sheath and at least two electrophysiological catheters. The at least two electrophysiological catheters include at least one mapping catheter and at least one ablation catheter. The electrophysiological sheath, the at least one mapping catheter, and the at least one ablation catheter are all electrically connected to the mapping system. The at least one mapping catheter and the at least one ablation catheter are used to pass through the guide channel formed by the at least one electrophysiological sheath from outside the patient's body into the patient's body. The mapping catheter is used for mapping. The at least one ablation catheter is also electrically connected to the ablation device, and the ablation device is used to perform ablation treatment on the patient through the ablation catheter. Alternatively, the at least one electrophysiological device includes a control platform integrating an interface unit, an ablation unit, and a mapping unit. The electrophysiological system includes at least one electrophysiological sheath and at least two electrophysiological catheters. The at least two electrophysiological catheters include at least one mapping catheter and at least one ablation catheter. The electrophysiological sheath, the at least one mapping catheter, and the at least one ablation catheter are all electrically connected to the mapping unit via the interface unit. The at least one mapping catheter and the at least one ablation catheter are used to penetrate from outside the patient's body into the patient's body through the guiding channel formed by the at least one electrophysiological sheath. The mapping catheter is used for mapping. The at least one ablation catheter is also electrically connected to the ablation unit via the interface unit. The ablation unit is used to perform ablation treatment on the patient through the ablation catheter.