An interventional catheter and an interventional device

Abstract

The application provides an interventional diagnosis and treatment catheter and a diagnosis and treatment equipment. It relates to the field of medical devices. The diagnosis and treatment equipment comprises a catheter sheath, a transducer unit and a catheter end interface, wherein the catheter end interface is connected to a host end interface; the catheter sheath is arranged outside the transducer unit, the distal end of the transducer unit is a detection end, and the detection end is located at the distal end of the catheter sheath; the proximal end of the catheter sheath is connected to a first shell of the catheter end interface, and the first shell is rotationally connected to a first rotating inner core of the catheter end interface; the proximal end of the transducer unit comprises a driving end and a signal transmission end, the driving end is connected to the first rotating inner core, and the signal transmission end is connected to a contact module in the first rotating inner core; in the case that the first shell is clamped to a second shell of the host end interface, the first rotating inner core is in transmission connection with a second rotating inner core of the host end interface, and the contact module is in electrical connection with a probe module in the second rotating inner core. The panoramic detection control is realized in all directions, and the detection signal can be fed back in real time.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an interventional catheter and a diagnosis and treatment device. BACKGROUND

[0002] At present, interventional diagnosis and treatment is a method that can intervene in the lesion of a patient under the guidance of medical imaging equipment (such as X-ray, CT, ultrasound, magnetic resonance imaging, etc.), and perform diagnosis and treatment by using a specially designed catheter and other instruments.

[0003] Current various catheters often provide limited-angle local information near the probe, and it is difficult to achieve real-time panoramic detection of 360 degrees, but in cardiovascular diseases, for example, panoramic imaging guidance is of great significance to the success of the operation. SUMMARY

[0004] Therefore, the present application provides an interventional catheter and a diagnosis and treatment device, which aims to solve the problem of difficult multi-directional panoramic detection.

[0005] In a first aspect, the present application provides an interventional catheter, which comprises a catheter sheath, a transducer unit 2 and a catheter end interface 3, wherein the catheter end interface 3 is connected to a host end interface 4.

[0006] The catheter sheath is sleeved on the outside of the transducer unit 2, the distal end of the transducer unit 2 is a detection end, and the detection end is located at the distal end of the catheter sheath.

[0007] The proximal end of the catheter sheath is connected to a first housing 31 of the catheter end interface 3, the first housing 31 is rotationally connected to a first rotating inner core 32 of the catheter end interface 3, the proximal end of the transducer unit 2 comprises a driving end and a signal transmission end, the driving end is connected to the first rotating inner core 32, and the signal transmission end is connected to a contact module 33 in the first rotating inner core 32.

[0008] When the first housing 31 and a second housing 41 of the host end interface 4 are clamped, the first rotating inner core 32 is in transmission connection with a second rotating inner core 42 of the host end interface 4, and the contact module 33 is in electrical connection with a probe module 43 in the second rotating inner core 42.

[0009] Optionally, the transducer unit 2 comprises a transducer 21, a torque spring 22 and a flexible circuit 23.

[0010] The transducer 21 is a detection end of the transducing unit 2, a distal end of the torque spring 22 is fixedly connected to the transducer 21, a proximal end of the torque spring 22 is fixedly connected to the first rotating inner core 32, a distal end of the flexible circuit 23 passes through an inner side of the torque spring 22 and is electrically connected to the transducer 21, and a proximal end of the flexible circuit 23 is electrically connected to the contact module 33.

[0011] Optionally, the transducing unit 2 further comprises a bearing 24, the bearing 24 comprises a supporting part and a connecting part;

[0012] A supporting plane of the supporting part supports and fixes the transducer 21 and part of the flexible circuit 23, and the connecting part fixedly connects the torque spring 22.

[0013] Optionally, the catheter sheath comprises a sheath tube 5 and a protective sheath 1 of the transducer 21;

[0014] The protective sheath 1 has acoustic transmittance;

[0015] An inner cavity of the protective sheath 1 communicates with the central cavity 51 of the sheath tube 5 to form a first chamber, the first chamber is a sealed chamber, and the first chamber is filled with a liquid acoustic matching medium 25.

[0016] Optionally, a plurality of bending guide wire cavities 52 are arranged in the length direction in the tube wall of the sheath tube 5, the plurality of bending guide wire cavities 52 are uniformly distributed around the central axis of the sheath tube 5, and a bending guide wire is arranged in each of the bending guide wire cavities 52.

[0017] The inner wall of the central cavity 51 of the sheath tube 5 is embedded with a braided layer.

[0018] Optionally, two sides of one of the plurality of bending guide wire cavities 52 are respectively provided with one mounting cavity 53 for arranging electronic devices, and the electronic devices include electronic devices for spatial perception.

[0019] Optionally, a sensor 7 is embedded on the tube wall of the sheath tube 5 near the protective sheath 1, the sensor 7 is used for multi-modal non-acoustic mapping; and / or, an electromagnetic ablation assembly 8 is embedded on the tube wall of the sheath tube 5 near the protective sheath 1.

[0020] Optionally, a catheter fixing part 35, a rotating bearing 36 and the first rotating inner core 32 are sequentially and sealingly connected in the first housing 31 from a first end connected to the catheter sheath to a second end connected to the second housing 41, and the spring fixing part 34 and the contact module 33 are sequentially arranged in the first rotating inner core 32 along the axis;

[0021] The first end of the catheter fixing member 35 is connected with the proximal end of the catheter sheath through the through hole of the first housing 31, and the first housing 31 is rotationally connected with the first rotating inner core 32 through the rotating bearing 36.

[0022] The catheter fixing member 35 comprises a first through hole 351 for accommodating the torque spring 22, the spring fixing member 34 comprises a second through hole 341 for accommodating the torque spring 22, the flexible circuit 23 passes through the first through hole and the second through hole 341 in sequence and is electrically connected with the contact module 33, and the second through hole 341 fixes the torque spring 22 and is sealed at the second end close to the contact module 33.

[0023] Optionally, the host interface 4 further comprises a mounting seat, the mounting seat comprises a base plate and a rotating shaft seat 45 rotationally connected with the base plate, the rotating shaft seat 45 is rotationally connected with the second rotating inner core 42, and the rotating shaft seat 45 is perpendicular to the base plate.

[0024] The second rotating inner core 42 is provided with a probe module 43, the probe module 43 comprises a contact pin array base module 431, a contact pin array 432 and a constraint workpiece 433 corresponding to the contact pin array 432, the first end of the contact pin array 432 is electrically connected with the contact pin array base module 431, and the second end of the contact pin array 432 is used for electrically connecting with the contact module 33.

[0025] In the second aspect, the application provides a diagnosis and treatment equipment, and the diagnosis and treatment equipment is the interventional diagnosis and treatment catheter.

[0026] The application provides an interventional diagnosis and treatment catheter and a diagnosis and treatment equipment. The interventional diagnosis and treatment catheter comprises a catheter sheath, a transducer unit and a catheter end interface, the catheter end interface is connected with a host end interface; the catheter sheath is arranged outside the transducer unit, a distal end of the transducer unit is a detection end, and the detection end is located at a distal end of the catheter sheath; a proximal end of the catheter sheath is connected with a first shell of the catheter end interface, and the first shell is rotationally connected with a first rotating inner core of the catheter end interface; a proximal end of the transducer unit comprises a driving end and a signal transmission end, the driving end is connected with the first rotating inner core, and the signal transmission end is connected with a contact point module in the first rotating inner core; when the first shell of the catheter end interface is clamped with a second shell of the host end interface, the first rotating inner core in the first shell and a second rotating inner core in the second shell are in transmission connection, the second rotating inner core drives the first rotating inner core to rotate through driving of the host end, and then the transducer unit can rotate in the catheter sheath, so that the detection end of the transducer unit can realize 360-degree rotary detection. In addition, the signal transmission end of the transducer unit is connected with the contact point module in the first rotating inner core, and the contact point module is electrically connected with a probe module of the host end, so as to realize transmission of electrical signals of the host end and the transducer unit. In this way, omnibearing panoramic detection control can be realized, and detection signals can be fed back in real time. BRIEF DESCRIPTION OF DRAWINGS

[0027] In order to more clearly illustrate the technical solutions in the embodiments or the prior art, the drawings needed to be used in the embodiments or the prior art description will be briefly introduced. Obviously, the drawings in the following description are only some embodiments of the application, and other drawings can be obtained by those skilled in the art without any creative effort.

[0028] Figure 1 A connection schematic diagram of the interventional diagnosis and treatment catheter provided by the embodiments of the application is provided.

[0029] Figure 2 An internal structure schematic diagram of the catheter end interface provided by the embodiments of the application is provided.

[0030] Figure 3 An internal structure schematic diagram of the host end interface provided by the embodiments of the application is provided.

[0031] Figure 4 A structure schematic diagram of the transducer unit in the catheter sheath provided by the embodiments of the application is provided.

[0032] Figure 5Cross-section structure of the catheter sheath transducer provided by the embodiment of the present application and 360° rotation schematic diagram of the transducing unit

[0033] Figure 6 Structure of the multifunctional section and the ordinary section of the adjustable bending section sheath tube and cross-section structure schematic diagram after the torque spring and the flexible circuit are installed respectively provided by the embodiment of the present application

[0034] Figure 7 Schematic diagram of the combination structure of the probe module and the contact module provided by the embodiment of the present application

[0035] Figure 8 Schematic diagram of the transmission structure of the first rotating inner core and the second rotating inner core provided by the embodiment of the present application

[0036] Figure 9 Schematic diagram of the combination structure of the catheter end interface and the host end interface provided by the embodiment of the present application

[0037] Explanation of figure number: 1-protective sheath; 2-transducing unit; 21-transducer; 22-torque spring; 23-flexible circuit; 24-bearing; 25-liquid acoustic matching medium; 241-supporting part; 242-connecting part; 3-catheter end interface; 31-first housing; 311-elastic clamping block; 312-guiding block; 32-first rotating inner core; 33-contact module; 34-spring fixing part; 341-second through hole; 35-catheter fixing part; 351-first through hole; 36-rotating bearing; 37-first sealing rubber ring; 38-second sealing rubber ring; 4-host end interface; 41-second housing; 411-guiding groove; 412-limiting hole; 42-second rotating inner core; 43-probe module; 431-needle array base module; 432-needle array; 433-restraining workpiece; 44-base; 45-rotating shaft seat; 5-sheath tube; 51-central cavity; 52-bending guide wire cavity; 53-mounting cavity; 6-catheter bending control mechanism; 7-sensor; 8-electromagnetic ablation assembly DETAILED DESCRIPTION

[0038] The imaging capability of the existing imaging catheter is limited to local imaging, for example, the catheter for intracardiac intervention imaging such as intracardiac echocardiography (ICE) can only provide local information within a limited angle near the probe, and it is difficult to provide 360° real-time panoramic structure, access and functional information in the heart, and the guiding ability in diagnosis and treatment is still insufficient. In addition, the existing intracardiac intervention catheter has a single function, for example, the imaging catheter, the electrophysiological mapping catheter and the ablation catheter are usually independent, the diagnosis and treatment functions are separated, and multiple catheters may be required during the intervention diagnosis and treatment, which increases the operation complexity and operation time, and also increases the cost. At the same time, the non-acoustic mapping capability is insufficient, and the existing intracardiac intervention catheter has not effectively integrated the measurement of non-acoustic information such as spatial positioning, electrophysiological monitoring or hemodynamics with imaging function, which limits the comprehensive utilization of multi-modal information.

[0039] In summary, the present application provides an intervention diagnosis and treatment catheter, which is provided with a transducer unit 2 capable of 360° rotation in the catheter sheath, and the first rotating inner core 32 in the first shell 31 and the second rotating inner core 42 in the second shell 41 can be drivingly connected while the first shell 31 and the second shell 41 are clamped, the second rotating inner core 42 drives the first rotating inner core 32 to rotate through the host end drive, and the transducer unit 2 can rotate in the catheter sheath, so that the detection end of the transducer unit 2 can realize 360° rotation detection. And the signal transmission end of the transducer unit 2 is connected with the contact module 33 in the first rotating inner core 32, the contact module 33 is electrically connected with the probe module 43 of the host end, the transmission of electrical signals between the host end and the transducer unit 2 is realized, the panoramic detection control is realized, and the detection signal can be fed back in real time. In addition, the catheter end interface 3 and the host end interface 4 are hot-plug connected, which is also convenient and flexible to replace.

[0040] Further, the sheath tube 5 side wall of the catheter sheath can be externally embedded with a sensor 7 for multi-modal non-acoustic mapping and an electromagnetic ablation assembly 8, and the pipe wall of the sheath tube 5 is arranged with a mounting cavity 53 containing electronic devices on both sides of one of the plurality of bending guide wire cavities 52 provided with bending guide wires, and the electronic devices of the mounting cavity 53 include but are not limited to electronic devices for spatial perception, so that the detection advancing direction of the sheath tube 5 is adjusted by controlling the swinging direction of the sheath tube 5 through the bending guide wire, and at the same time, the detection direction of the sheath tube 5 is fed back in real time by arranging the electronic devices for spatial perception, so that the spatial positioning, the non-acoustic information such as electrophysiological monitoring or hemodynamics obtained through the non-acoustic mapping sensor 7 and the imaging function are combined, which is beneficial to the comprehensive utilization of multi-modal information.

[0041] In order to enable a more detailed understanding of the features and technical content of the embodiments of the present disclosure, the implementation of the embodiments of the present disclosure will be described in detail below with reference to the accompanying drawings, which are only used for reference and do not limit the embodiments of the present disclosure. In the following technical description, in order to facilitate explanation, a plurality of details are provided to provide a full understanding of the disclosed embodiments. However, one or more embodiments can still be implemented without these details. In other cases, well-known structures and devices can be simplified to facilitate the drawings.

[0042] The terms "first", "second", and the like in the specification and claims of the embodiments of the present disclosure and the above-mentioned drawings are used to distinguish similar objects, and do not necessarily describe a specific order or sequence. It should be understood that the data thus used can be interchanged under appropriate circumstances, so that the embodiments of the present disclosure described herein can be implemented. In addition, the terms "include" and "have" and any variations thereof are intended to cover non-exclusive inclusion.

[0043] Unless otherwise specified, the term "a plurality of" means two or more. In the embodiments of the present disclosure, the character " / " represents that the objects before and after are in an "or" relationship. For example, A / B represents: A or B. The term "and / or" is a description of the association between objects, which means that there can be three relationships. For example, A and / or B, which means: A or B, or, A and B, three relationships.

[0044] In order to make the purposes, technical solutions and advantages of the embodiments of the present application more clear, the technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, not all embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative labor fall within the scope of protection of the present application.

[0045] Referring to Figure 1 A connection diagram of an interventional diagnosis and treatment catheter provided by the embodiments of the present application and Figure 4 A structural diagram of a catheter sheath internal transducer unit, an interventional diagnosis and treatment catheter, comprising: a catheter sheath, a transducer unit 2 and a catheter end interface 3, the catheter end interface 3 is connected to a host end interface 4;

[0046] The catheter sheath is arranged outside the transduction unit 2, the distal end of the transduction unit 2 is a detection end, and the detection end is located at the distal end of the catheter sheath; the proximal end of the catheter sheath is connected to a first shell 31 of a catheter terminal interface 3, the first shell 31 is rotationally connected to a first rotating inner core 32 of the catheter terminal interface 3, the proximal end of the transduction unit 2 includes a driving end and a signal transmission end, the driving end is connected to the first rotating inner core 32, and the signal transmission end is connected to a contact module 33 in the first rotating inner core 32; in the clamped state of the first shell 31 and a second shell 41 of a host terminal interface 4, the first rotating inner core 32 is in transmission connection with a second rotating inner core 42 of the host terminal interface 4, and the contact module 33 is in electrical connection with a probe module 43 in the second rotating inner core 42.

[0047] The transduction unit 2 described above is connected to the contact module 33 in the first rotating inner core 32 through the signal transmission end, is connected to the probe module 43 in the second rotating inner core 42 through the contact module 33, receives an electrical signal sent by the host terminal, converts the electrical signal into a detection signal at the detection end, obtains a feedback signal based on the detection signal, and feeds back the feedback signal to the host terminal.

[0048] Optionally, the transmission structure in transmission connection between the first rotating inner core 32 and the second rotating inner core 42 is any one of a spiral riveting transmission structure, a tooth-embedded flange transmission structure, an end face tooth flange transmission structure, and a magnetic coupling transmission structure.

[0049] Optionally, the contact module 33 and the probe module 43 are in electrical connection, which can be one-to-one correspondence between a contact pin in the probe module 43 and a contact in the contact module 33, electrical connection in the manner of a PCB, or electrical connection of any type of male and female connector, such as an aviation male and female connector with multiple contact pins, an IDC connector with multiple contact pins, and a PCB connector with multiple contact pins.

[0050] The catheter sheath described above is used to protect the transduction unit 2 and also provides a space for the transduction unit 2 to rotate for detection. Therefore, the catheter sheath is connected to the first shell 31 of the catheter terminal interface, and the transduction unit 2 is connected to the first rotating inner core 32 arranged inside the first shell 31 and rotationally connected to the first shell 31. In this way, when the host terminal drives the second rotating inner core 42 in the host terminal interface 4 to rotate, the first rotating inner core 32 in transmission connection with the second rotating inner core 42 can also be driven to rotate, and the transduction unit 2 in the catheter sheath can be driven to rotate by 360 degrees for omnidirectional detection.

[0051] In this way, based on the diagnosis and treatment catheter described above, omnidirectional panoramic detection control is achieved, and the detection signal can be fed back in real time. In addition, the catheter terminal interface 3 and the host terminal interface 4 are in hot plug connection, which is convenient and flexible for replacing the catheter.

[0052] In the embodiments of the present application, the above Figure 1 The transduction unit 2 has possible implementation manners, which are specifically introduced below. It should be noted that the implementation manners given in the following introduction are only exemplary and do not represent all implementation manners of the embodiments of the present application.

[0053] Referring to Figure 4 The transduction unit 2 has possible implementation manners, which are specifically introduced below. It should be noted that the implementation manners given in the following introduction are only exemplary and do not represent all implementation manners of the embodiments of the present application. Figure 5 The transduction unit 2 has possible implementation manners, which are specifically introduced below. It should be noted that the implementation manners given in the following introduction are only exemplary and do not represent all implementation manners of the embodiments of the present application.

[0054] The transduction unit 2 includes a transducer 21, a torque spring 22 and a flexible circuit 23.

[0055] The transducer 21 is a detection end of the transduction unit 2, the distal end of the torque spring 22 is fixedly connected to the transducer 21, the proximal end of the torque spring 22 is fixedly connected to the first rotating inner core 32, the distal end of the flexible circuit 23 passes through the inside of the torque spring 22 and is electrically connected to the transducer 21, and the proximal end of the flexible circuit 23 is electrically connected to the contact module 33.

[0056] Optionally, the transducer 21 at the detection end of the transduction unit 2 can be provided with a plurality of transducers 21, which can form a transducer 21 array in any form, such as a linear array, an arc surface array, etc., and the parameters of the array are not limited, and different arrays can be selected according to different application environments in terms of frequency, array element number, array element spacing, array element distribution scheme, etc. Optionally, the plurality of transducers 21 provided at the detection end of the transduction unit 2 can also be divided into a plurality of transducer 21 modules, each transducer 21 module includes at least one transducer 21, and the layout of the plurality of transducer 21 modules can be a layout form in which a plurality of linear arrays, a combination of linear arrays and surface arrays, and a plurality of surface arrays are combined with each other.

[0057] The proximal end of the torque spring 22 is a driving end, the first rotating inner core 32 is driven to rotate by the host end, the torque spring 22 fixedly connected to the first rotating inner core 32 also rotates, and then drives the transducer 21 fixedly connected to the distal end of the torque spring 22 to rotate, so as to realize 360-degree omnidirectional detection, as shown in Figure 5 The dashed arrow indicates the rotation track of the 360-degree rotation of the transducer 21, and the shaded area of the trapezoid is an acoustic detection coverage diagram of the transducer 21.

[0058] The proximal end of the flexible circuit 23 connected with the contact module 33 is a signal transmission end, the flexible circuit 23 passes through the hollow area inside the torque spring 22, and the distal end of the flexible circuit 23 is electrically connected with the transducer 21. The high-frequency electric signal sent by the host end is transmitted through the flexible circuit 23, the transducer 21 sends the ultrasonic wave emission excitation signal for detection and the high-frequency echo signal received and feeds back to the host end based on the high-frequency electric signal.

[0059] Further, referring to Figure 4 , the catheter sheath includes the sheath tube 5 and the protective sheath 1 of the transducer 21.

[0060] The protective sheath 1 has acoustic permeability; the inner cavity of the protective sheath 1 is in communication with the central cavity 51 of the sheath tube 5 to form a first chamber, the first chamber is a sealed chamber, and the first chamber is filled with the liquid acoustic matching medium 25.

[0061] The opening end of the protective sheath 1 with acoustic permeability is fusion sealed corresponding to the distal end of the sheath tube 5 to form the first chamber, the first chamber is a sealed chamber, the transducer 21 is isolated from the external environment, and the liquid acoustic matching medium 25 is filled to ensure acoustic permeability, so that the transducer 21 can stably emit the ultrasonic wave excitation signal for detection and the high-frequency echo signal received.

[0062] In a possible implementation, referring to Figure 4 , the transduction unit 2 further includes a carrier 24, the carrier 24 includes a supporting part 241 and a connecting part 242; the supporting plane of the supporting part 241 supports and fixes the transducer 21 and part of the flexible circuit 23, and the connecting part 242 is fixedly connected with the torque spring 22.

[0063] Optionally, the connecting part 242 can be a circular ring, one end of the connecting part 242 is fixed with the supporting part 241, and the other end of the connecting part 242 is coaxially fixed with the torque spring 22; the part of the flexible circuit 23 is located between the connecting part 242 and the transducer 21, and the part of the flexible circuit 23 can pass through the inner ring via hole of the connecting part and be arranged in adhesion with the supporting plane.

[0064] Optionally, the carrier 24 of the transducer 21 is matched and arranged according to the designed transducer 21 array in structure.

[0065] In this way, the torque spring 22 transmits the rotation torque generated by the host end to the carrier 24 of the transducer 21, drives the transducer 21 to rotate together with the flexible circuit 23, and realizes that the acoustic detection range of the transducer 21 covers the 360° circumferential area, as Figure 4 .

[0066] In the embodiment of the application, the above Figure 4The sheath pipe can have various possible implementations, which will be described in detail below. It should be noted that the implementations given in the following description are only exemplary and do not represent all implementations of the present application.

[0067] In one possible implementation, the sheath pipe 5 can be divided into an adjustable bending section and a protection section, or can be entirely adjustable bending section. The structure of the adjustable bending section of the sheath pipe 5 can be seen from Figure 6 The sheath pipe shown in the adjustable bending section has a multifunctional section and a common section, each having a structure and a cross-sectional structure after installation of a torque spring and a flexible circuit. A plurality of bending guide wire cavities 52 are arranged in the pipe wall of the sheath pipe 5 along the length direction, and the plurality of bending guide wire cavities 52 are uniformly distributed around the central axis of the sheath pipe 5. A bending guide wire is arranged in each of the bending guide wire cavities 52.

[0068] The inner wall of the central cavity 51 of the sheath pipe 5 is embedded with a braided layer for adjusting the bending rigidity of the catheter at different catheter sections.

[0069] The bending guide wire can be arranged in the front section of the sheath pipe 5. The bending guide wire is led out from the bending guide wire cavity 52 close to the end of the main machine and connected with the catheter bending control mechanism 6. By pulling the bending guide wire in the bending guide wire cavity 52 corresponding to the target direction, the bending guide wire controls the front section of the sheath pipe 5 to swing towards the target direction, thereby guiding the protection sheath 1 to detect towards the target direction.

[0070] Optionally, the number of bending guide wire cavities 52 on the sheath pipe 5 is four. The four bending guide wire cavities 52 are uniformly distributed around the central axis of the sheath pipe 5, i.e. on the vertical cross section of the sheath pipe 5, the angle between the center lines of the two adjacent bending guide wire cavities 52 is 90 degrees. Of course, other numbers are also possible.

[0071] Optionally, the plurality of bending guide wire cavities 52 can be arranged adjacent to the inner wall of the sheath pipe 5 in the pipe wall of the sheath pipe 5.

[0072] Further, one of the plurality of bending guide wire cavities 52 is provided with two mounting cavities 53 for arranging electronic devices on both sides, respectively. The electronic devices include electronic devices for spatial perception.

[0073] Optionally, the mounting cavities 53 can also form electronic paths with wiring.

[0074] Optionally, the electronic devices embedded in the mounting cavities 53 can also include other devices capable of providing guidance for catheter diagnosis and treatment.

[0075] For example, the electronic device for spatial perception can perceive the position and posture of the catheter and feed back the perception information through the electronic channel in the installation cavity 53, to provide more accurate orientation guidance. For example, the electromagnetic sensor 7 can perceive the strength and direction of the magnetic field based on a low-strength alternating magnetic field generated by the magnetic field generator, and calculate the position, direction and posture of the catheter in the body according to the change of the magnetic field signal received by the electromagnetic sensor 7.

[0076] Further, referring to Figure 6 The sheath tube of the adjustable bending section can be divided into a multifunctional section and a common section, wherein the multifunctional section is arranged adjacent to the protective sheath 1, and the specific structure of the multifunctional section of the adjustable bending section sheath tube 5 can further be that a sensor 7 for multi-modal non-acoustic mapping is embedded on the outer wall of the multifunctional section of the sheath tube 5, and / or an electromagnetic ablation assembly 8 is embedded on the outer wall of the sheath tube 5 adjacent to the protective sheath 1.

[0077] In one possible case, the sheath tube 5 has a sensor 7 for multi-modal non-acoustic mapping embedded on the outer wall of the sheath tube 5 adjacent to the protective sheath 1. In another possible case, the sheath tube 5 has an electromagnetic ablation assembly 8 embedded on the outer wall of the sheath tube 5 adjacent to the protective sheath 1. In yet another possible case, the sheath tube 5 has a sensor 7 for multi-modal non-acoustic mapping and an electromagnetic ablation assembly 8 embedded on the outer wall of the sheath tube 5 adjacent to the protective sheath 1.

[0078] Optionally, a balloon, a flexible electrode, etc. can also be arranged on the outer wall of the multifunctional section of the adjustable bending section sheath tube 5 as needed.

[0079] The sheath tube 5 forms a torque spring 22 transmission channel, a bending guide wire traction channel and an electronic sensor channel through the inner layer structure of the multi-chamber, and the outer layer structure of the sheath tube 5 can embed multiple electrodes and multiple sensors 7 for mapping electrophysiological information, environmental pressure and other non-acoustic parameters, and integrate a radiofrequency ablation module to support treatment functions. Through the structural design of the multi-chamber and the inner and outer layer multifunctional area, the catheter not only has the ability to map spatial position, electrophysiological information and pressure information and other non-acoustic information and the function of electromagnetic ablation while being bent and transported in the channel to intervene the detection end, but also can fuse image, multi-modal information mapping and ablation treatment functions, realize the development of a multifunctional diagnosis and treatment integrated catheter, and improve the diagnosis and treatment efficiency of doctors and reduce costs.

[0080] In the embodiments of the present application, the above Figure 1 The catheter end interface 3 and the host end interface 4 can be implemented in various ways, which will be described in detail below. It should be noted that the implementation modes given in the following description are only exemplary and do not represent all implementation modes of the embodiments of the present application.

[0081] Referring toFigure 2 An internal structure diagram of one of the conduit end interfaces is shown. The internal structure of the conduit end interface 3 can be as follows:

[0082] The first housing 31 is sequentially connected with a conduit fixing member 35, a rotating bearing 36 and a first rotating inner core 32 from a first end connected with a conduit sheath to a second end connected with a second housing 41, and the first rotating inner core 32 is sequentially installed with a spring fixing member 34 and a contact module 33 along an axis;

[0083] The first end of the conduit fixing member 35 is connected with the proximal end of the conduit sheath through a through hole of the first housing 31, and the first housing 31 is rotationally connected with the first rotating inner core 32 through the rotating bearing 36;

[0084] The conduit fixing member 35 includes a first through hole 351 through which the torque spring 22 passes, the spring fixing member 34 includes a second through hole 341 through which the torque spring 22 passes, the flexible circuit 23 sequentially passes through the first through hole and the second through hole 341 and is electrically connected with the contact module 33, and the second through hole 341 fixes the torque spring 22 and is sealed near the second end of the contact module 33.

[0085] Referring to Figure 2 , the first housing 31 is connected with the conduit sheath through the conduit fixing member 35. For example, the conduit fixing member 35 is sealingly connected with the first housing 31, the first end of the conduit fixing member 35 is sealingly connected with the conduit sheath, and the conduit fixing member 35 is provided with a limiting block on the side wall near the second end. The first housing 31 is provided with a mounting through hole (optionally, a sealing rubber ring can be arranged between the through hole and the conduit fixing member 35 for sealing connection) corresponding to the conduit fixing member 35 and a sink corresponding to the limiting block protruding on the side wall of the conduit fixing member 35, so as to limit the rotation of the conduit fixing member 35 relative to the first housing 31.

[0086] The spring fixing member 34 is mounted and fixed in the first rotating inner core 32, and the side wall of the spring fixing member 34 and the through hole corresponding to the first rotating inner core 32 can be sealingly connected through a sealing rubber ring.

[0087] Referring to Figure 2 , the first housing 31 is rotationally connected with the first rotating inner core 32 through the rotating bearing 36, a first sealing rubber ring 37 is arranged between the first housing 31 and the rotating bearing 36, and a second sealing rubber ring 38 is arranged between the rotating bearing 36 and the first rotating inner core 32. In this way, the decoupling design of the first housing 31 and the first rotating inner core 32 is realized through the rotating bearing 36.

[0088] Further, the conduit fixing member 35 is provided with a hollow first through hole 351 from the first end to the second end, and the torque spring 22 and the flexible circuit 23 in the torque spring 22 pass through the first through hole 351 into the first shell 31. Further, the torque spring 22 and the flexible circuit 23 in the torque spring 22 entering the first shell 31 also extend to the second through hole 341 of the spring fixing member 34, wherein the flexible circuit 23 passes through the second through hole 341 to be electrically connected with the contact module 33 for electrical signal transmission, and the torque spring 22 extends to the end face of the second through hole 341 close to the host end and is fixed with the spring fixing member 34 to seal the end face of the second through hole 341 close to the host end, so that the first cavity forms a sealed cavity.

[0089] Further, referring to Figure 3 the internal structure of the host end interface shown in the internal structure diagram of the host end interface. The internal structure of the host end interface 4 can be:

[0090] The host end interface 4 further comprises a mounting seat, the mounting seat comprises a chassis and a rotating shaft seat 45 rotationally connected with the chassis, the rotating shaft seat 45 has a rotation axis perpendicular to the chassis, the chassis is fixedly connected with the second shell 41, and the rotating shaft seat 45 is fixedly connected with the second rotating inner core 42.

[0091] The second rotating inner core 42 is provided with a probe module 43, the probe module 43 comprises a contact pin array base module 431, a contact pin array 432 and a constraint workpiece 433 corresponding to the contact pin array 432, a first end of the contact pin array 432 is electrically connected with the contact pin array base module 431, and a second end of the contact pin array 432 is used for electrical connection with the contact module 33.

[0092] Referring to Figure 7 the combined structure diagram of the probe module and the contact module, the contact pin array 432 of the host end is fixed into a specific spatial shape through the constraint workpiece 433 and is embedded into the contact pin array base module 431, and the contact pin array base module 431 is connected with the host through a transmission link. The second end of the contact pin array 432 is used for electrical connection with the contact module 33.

[0093] In addition, the second shell 41 of the host end interface 4 is directly connected with the host shell, so as to ensure stability and structural integrity.

[0094] Referring to Figure 8 the transmission structure diagram of the first rotating inner core and the second rotating inner core, optionally, the transmission structure of the transmission connection between the first rotating inner core 32 and the second rotating inner core 42 is a spiral riveting transmission structure, so as to realize self-anchoring docking function at any angle.

[0095] Optionally, the matching structure of the clamping of the first shell 31 and the second shell 41 can be seen from Figure 9 The schematic diagram of the combination structure of the catheter end interface and the host end interface is shown in the first shell 31, which includes the elastic clamping blocks 311 symmetrically arranged on both sides of the first shell 31 and the guide blocks 312 symmetrically arranged on both sides of the first shell 31. The second shell 41 is provided with a guide groove 411 corresponding to the guide blocks, and is provided with a limiting hole 412 corresponding to the elastic clamping blocks 311. In this way, when the guide blocks 312 of the first shell 31 move along the guide groove 411 of the second shell 41 and the elastic clamping blocks 311 are clamped into the corresponding limiting holes 412, the clamping is completed.

[0096] Optionally, the transmission structure of the transmission connection between the first rotating inner core 32 and the second rotating inner core 42 can also be any other type of contact and non-contact self-adaptive riveting transmission structure. For example, the contact type is a toothed flange transmission structure, an end face tooth flange transmission structure, etc.; the non-contact type is a magnet coupling transmission structure, etc.

[0097] The catheter end interface 3 and the host end interface 4 are hot-plug connected to realize the connection of the transmission structure (including the torque spring 22, the spring fixing part 34, the first rotating inner core 32, the second rotating inner core 42, etc.) and the signal link structure (the flexible circuit 23, the contact module 33 in the first rotating inner core 32 and the probe module 43 in the second rotating inner core 42) between the catheter end and the host end. The rotating inner core and the corresponding shell are decoupled to protect the stability of the transmission structure in the shell. In this way, the hot-plug connection between the catheter end interface 3 and the host end interface 4 is realized while maintaining the communication of the transmission link and the signal link, and the flexibility and replaceability of the catheter are realized in hardware.

[0098] The application also provides a diagnosis and treatment device for realizing the scheme provided in the application.

[0099] The diagnosis and treatment device applies the diagnosis and treatment catheter provided in any one of the above embodiments.

[0100] The "first" and "second" in the names mentioned in the embodiments of the application are only used for name identification, and do not represent the first and second in order. Each embodiment in the specification is described in a progressive manner, and the same parts of each embodiment can be referred to each other. Each embodiment focuses on the differences from other embodiments.

[0101] The above is only an exemplary embodiment of the application, and is not used to limit the protection scope of the application.

Claims

1. An interventional diagnostic and therapeutic catheter, characterized in that, include: The catheter sheath, the transducer unit, and the catheter end interface are connected to the host end interface. The catheter sheath is sleeved on the outside of the transducer unit, and the distal end of the transducer unit is the probe end, which is located at the distal end of the catheter sheath. The proximal end of the catheter sheath is connected to a first outer shell of the catheter end interface, and the first outer shell is rotatably connected to a first rotating inner core of the catheter end interface. The proximal end of the transducer unit includes a driving end and a signal transmission end. The driving end is connected to the first rotating inner core, and the signal transmission end is connected to the contact module in the first rotating inner core. When the first outer shell and the second outer shell of the host interface are engaged, the first rotating inner core is drivenly connected to the second rotating inner core of the host interface, and the contact module is electrically connected to the probe module in the second rotating inner core. The transducer unit includes a transducer, a torque spring, and a flexible circuit. The transducer is the detection end of the transducer unit. The distal end of the torque spring is fixedly connected to the transducer, and the proximal end of the torque spring is fixedly connected to the first rotating inner core. The distal end of the flexible circuit passes through the inner side of the torque spring and is electrically connected to the transducer. The proximal end of the flexible circuit is electrically connected to the contact module. The first outer shell contains a catheter fixing component, a rotary bearing, and a first rotating inner core, which are sequentially sealed and connected from the first end of the connecting catheter sheath to the second end of the connecting catheter sheath. The first rotating inner core contains a spring fixing component and a contact module sequentially installed along the axis. The first end of the catheter fixation component passes through the through hole of the first housing and is sealed to the proximal end of the catheter sheath. The first housing and the first rotating inner core are rotatably connected through the rotating bearing. The conduit fixing member includes a first through hole for accommodating the torque spring, and the spring fixing member includes a second through hole for accommodating the torque spring. The flexible circuit passes through the first through hole and the second through hole in sequence and is electrically connected to the contact module. The second through hole fixes and seals the torque spring at a second end adjacent to the contact module. The host interface also includes a mounting base, which includes a chassis and a rotating shaft seat rotatably connected to the chassis. The rotating shaft seat has a rotation axis perpendicular to the chassis. The chassis is fixedly connected to the second outer shell, and the rotating shaft seat is fixedly connected to the second rotating inner core. The second rotating inner core is equipped with a probe module, which includes a stylus array base module, a stylus array, and a constraint workpiece set with the stylus array. The first end of the stylus array is electrically connected to the stylus array base module, and the second end of the stylus array is used to be electrically connected to the contact module.

2. The catheter according to claim 1, characterized in that, The transducer unit also includes a support member, which includes a supporting part and a connecting part; The supporting plane of the supporting part supports and fixes the transducer and part of the flexible circuit, and the connecting part is fixedly connected to the torque spring.

3. The catheter according to claim 1, characterized in that, The catheter sheath includes a sheath tube and a protective sheath for the transducer; The protective sheath is acoustically permeable; The inner cavity of the protective sheath is connected to the central cavity of the sheath tube to form a first chamber. The first chamber is a sealed chamber and is filled with a liquid acoustic matching medium.

4. The catheter according to claim 3, characterized in that, The sheath has multiple bending guide wire cavities arranged along its length inside the tube wall. These cavities are evenly distributed around the central axis of the sheath, and each cavity contains a bending guide wire. The inner wall of the central cavity of the sheath is inlaid with a braided layer.

5. The catheter according to claim 4, characterized in that, One of the multiple bending guide wire cavities has a mounting cavity on each side for arranging electronic devices, including electronic devices for spatial sensing.

6. The catheter according to claim 4 or 5, characterized in that, The sheath has a sensor embedded in the outer wall near the protective sheath, the sensor being used for multimodal non-acoustic mapping; and / or, the sheath has an electromagnetic ablation component embedded in the outer wall near the protective sheath.

7. A diagnostic and treatment device, characterized in that, The interventional diagnostic and therapeutic catheter described in any one of claims 1-6 is applied.

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