A control knob for a torquing handle of a dielectric mapping catheter

Abstract

This invention discloses a transmission handle for controlling a ring-shaped dielectric mapping catheter. The transmission handle of this invention is mounted on a robotic arm and controlled by the robotic arm. The transmission handle includes a rotation control assembly, a traction wire fixing cylinder, a fixing part, and a hand-held part. The transmission handle designed by this invention can achieve precise control of the bidirectional bending, forward and backward pushing, and axial rotation of the catheter. Thus, under the guidance of a three-dimensional mapping system, precise control of the catheter tip can be achieved, reducing the difficulty of surgery and improving the quality and efficiency of surgery.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a drive handle for controlling a ring dielectric mapping catheter. Background Technology

[0002] Catheter radiofrequency ablation is currently the most commonly used minimally invasive interventional technique for treating arrhythmias. In clinical practice, catheter ablation surgery requires first performing percutaneous vascular puncture to establish a catheter access route. Under fluoroscopic or 3D imaging guidance, the catheter is inserted into the target cardiac chamber. Then, under the guidance of electrophysiological and 3D imaging technology, the surgeon manually manipulates the catheter outside the patient's body to locate and ablate the arrhythmia lesion. However, this entire process requires the surgeon to precisely manipulate the catheter manually, and the stability and accuracy of manual catheter manipulation cannot be effectively guaranteed. Therefore, current methods of performing radiofrequency ablation by manually manipulating the catheter have many inconveniences and safety risks. Summary of the Invention

[0003] This invention provides a drive handle for controlling an annular dielectric mapping catheter, thereby solving the problem that existing technologies cannot accurately control ablation catheters.

[0004] This invention provides a control device for a ring-shaped dielectric calibration catheter. The transmission handle is mounted on a robotic arm and includes a rotation control assembly, a traction wire drive cylinder, a fixing part, and a handheld part. The catheter enters through the head of the traction wire drive cylinder and is connected to a signal line at the end of the traction wire drive cylinder. The rotation control assembly is fixed to one side of the head of the traction wire drive cylinder. The fixing part is disposed on the catheter at the end of the traction wire drive cylinder. The handheld part is sleeved around the traction wire drive cylinder for gripping.

[0005] The catheter is symmetrically embedded with a first traction wire and a second traction wire, wherein the first end of the first traction wire and the first end of the second traction wire are both located at a preset position at the head of the catheter, and the second end of the first traction wire and the second end of the second traction wire are both connected to the end of the traction wire transmission cylinder.

[0006] Based on the control of the robotic arm, with the cooperation of the rotation control component and the traction wire drive cylinder, the rotation control component pulls the first traction wire or the second traction wire to achieve bidirectional bending of the catheter tip, and the rotation control component is controlled to achieve the rotation of the catheter, ultimately realizing the target mapping process.

[0007] Optionally, the rotary control assembly includes: a first bevel gear and a second bevel gear;

[0008] The first bevel gear is disposed at the head of the traction wire drive cylinder, and the first bevel gear and the second bevel gear rotate synchronously to drive the guide tube to rotate axially;

[0009] The second bevel gear is rotatably connected to the first bevel gear. The rotation of the second bevel gear drives the first traction wire or the second traction wire to achieve bidirectional bending of the catheter tip.

[0010] Optionally, the inner wall of the traction wire drive cylinder is provided with a position locking groove, which enables the first bevel gear and the traction wire drive cylinder to rotate synchronously along the axial direction, and the second bevel gear is screwed onto the outside of the traction wire drive cylinder.

[0011] Optionally, the second bevel gear is provided with a limiting groove for engaging the first bevel gear, the limiting groove being used to restrict the radial movement of the second bevel gear.

[0012] Optionally, the end of the traction wire drive cylinder is provided with a first connecting hole and a second connecting hole. The first traction wire is fixed to the first connecting hole, and the second traction wire is fixed to the second connecting hole by passing around the fixing member on the fixing part. This allows the rotation of the second bevel gear in different directions to pull the first traction wire or the second traction wire to achieve bending of the catheter tip in different directions.

[0013] Optionally, the transmission handle is fixed to the robotic arm by a support, the support being provided with a third bevel gear and a fourth bevel gear, wherein the third bevel gear meshes with the first bevel gear and the fourth bevel gear meshes with the second bevel gear;

[0014] The control commands on the robotic arm are transmitted to the rotary control assembly via the third and fourth bevel gears.

[0015] Optionally, the conduit is secured within the transmission handle by a snap-fit ​​device.

[0016] Optionally, the head of the catheter is provided with an annular mapping section with a ring-shaped opening, and the annular mapping section is made of shape memory material, and the annular mapping section is provided with more than 10 mapping electrodes.

[0017] Optionally, the catheter is embedded with a metal braided mesh, which is located radially outside the first traction wire and the second traction wire.

[0018] Optionally, the robotic arm is connected to the main control data processing system, which controls the rotation control component through the robotic arm to pull the first traction wire or the second traction wire to achieve bidirectional bending of the guide tube tip, ultimately realizing the target mapping process.

[0019] The beneficial effects of this invention are as follows:

[0020] The transmission handle of the present invention is mounted on a robotic arm and controlled by the robotic arm. The transmission handle includes a rotation control assembly, a traction wire transmission cylinder, a fixing part, and a hand-held part. The transmission handle designed by the present invention can achieve precise control of the bidirectional bending, forward and backward pushing, and axial rotation of the catheter. Thus, under the guidance of the three-dimensional mapping system, precise control of the catheter tip can be achieved, reducing the difficulty of surgery and improving the quality and efficiency of surgery.

[0021] The above description is merely an overview of the technical solution of the present invention. In order to better understand the technical means of the present invention and to implement it in accordance with the contents of the specification, and in order to make the above and other objects, features and advantages of the present invention more apparent and understandable, specific embodiments of the present invention are described below. Attached Figure Description

[0022] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the invention. Furthermore, the same reference numerals denote the same parts throughout the drawings. In the drawings:

[0023] Figure 1 This is a schematic diagram of the overall structure of the transmission handle for controlling the annular dielectric calibration guide provided in an embodiment of the present invention;

[0024] Figure 2 This is a schematic diagram of the internal structure of the transmission handle of a control ring dielectric measuring guide provided in an embodiment of the present invention;

[0025] Figure 3 This is a schematic diagram of the structure of the traction wire drive cylinder provided in an embodiment of the present invention;

[0026] Figure 4 This is a schematic diagram of a unidirectional electrode acquiring node signal provided in an embodiment of the present invention;

[0027] Figure 5 This is a schematic diagram of a catheter tip structure provided in an embodiment of the present invention;

[0028] Figure 6 This is a schematic diagram of another catheter tip structure provided in an embodiment of the present invention;

[0029] Figure 7 This is a schematic diagram of the catheter tip insertion structure provided in an embodiment of the present invention;

[0030] Figure 8 This is a schematic diagram of the catheter cross-section provided in an embodiment of the present invention;

[0031] Figure 9 This is an overall schematic diagram of the catheter control system provided in an embodiment of the present invention;

[0032] Figure 10 This is a schematic diagram of the signal control method of the catheter control system provided in an embodiment of the present invention.

[0033] Reference numerals: 1. conduit, 2. spin control assembly, 3. handheld part, 4. fixing part, 5. signal line, 6. traction wire drive cylinder, 7. robotic arm, 8. support, 9. main control data processing system, 10. control terminal;

[0034] 11 Electrode pair, 12 Visual electrode, 13 Catheter cannula, 14 Metal braided mesh, 15 Electrode signal line, 16 First traction wire, 17 Second traction wire;

[0035] 21 First bevel gear, 22 Second bevel gear;

[0036] 41. Fasteners;

[0037] 61 First connecting hole, 62 Second connecting hole, 63 External thread, 64 Position locking groove. Detailed Implementation

[0038] The present invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and do not limit the scope of the invention.

[0039] This invention provides a drive handle for controlling an annular dielectric calibration catheter, see [link to relevant documentation]. Figure 1 and Figure 2 The transmission handle is mounted on the robotic arm 7, and the main control data processing system 9 controls the transmission handle through the robotic arm 7 to ultimately achieve the target measurement process.

[0040] In this embodiment of the invention, the transmission handle includes: a rotation control assembly 2, a traction wire transmission cylinder 6, a fixing part 4, and a handheld part 3. The conduit 1 enters from the head of the traction wire transmission cylinder 6 and is connected to the signal line 5 (which is connected to the electrode signal line 15) at the end of the traction wire transmission cylinder 6. The rotation control assembly 2 is fixed to one side of the head of the traction wire transmission cylinder 6. The fixing part 4 is disposed at the conduit 1 at the end of the traction wire transmission cylinder 6. The handheld part 3 is sleeved around the traction wire transmission cylinder 6 for gripping.

[0041] It should be noted that the length of the traction wire drive cylinder 6 in this embodiment of the invention can be set as needed, specifically to meet the basic principle of operator grip.

[0042] The catheter 1 is symmetrically embedded with a first traction wire 16 and a second traction wire 17. The first end of the first traction wire 16 and the first end of the second traction wire 17 are both located at a preset position at the head of the catheter 1. The second end of the first traction wire 16 and the second end of the second traction wire 17 are both connected to the end of the traction wire transmission cylinder 6.

[0043] In specific embodiments of the present invention, the connection method between the first traction wire 16 and the second traction wire 17 and the traction wire transmission cylinder 6 can be arbitrarily set by those skilled in the art. For example, a first connecting hole 61 and a second connecting hole 62 can be provided at the end of the traction wire transmission cylinder 6. The first traction wire 16 is directly fixed to the first connecting hole 61, and the second traction wire 17 bypasses the fixing member 41 on the fixing part 4 and is fixed to the second connecting hole 62. This allows the rotation of the second bevel gear 22 in different directions to pull the first traction wire 16 or the second traction wire 17 to achieve bending of the head end of the conduit 1 in different directions.

[0044] Of course, the first traction wire 16 and the second traction wire 17 can also be controlled by setting different rotation control components 2. In this case, the first traction wire 16 and the second traction wire 17 can be directly fixed to the traction wire transmission cylinder 6 without having to go around the fixing member 41 on the fixing part 4.

[0045] The specific details can be set arbitrarily by those skilled in the art, and this invention will not elaborate on them.

[0046] Based on the control of the robotic arm 7, with the cooperation of the rotation control component 2 and the traction wire transmission cylinder 6, the rotation control component 2 pulls the first traction wire 16 or the second traction wire 17 to achieve bidirectional bending of the head end of the catheter 1, and the axial rotation of the catheter 1 is achieved by controlling the rotation control component 2, ultimately realizing the target marking process.

[0047] To prevent the catheter 1 from vibrating or rotating due to accidental contact, after the catheter 1 is embedded into the transmission handle, this embodiment of the invention further uses a snap-fit ​​device to hold the catheter 1 in the transmission handle, so as to achieve precise control of the catheter 1.

[0048] It should be noted that the buckling component in the embodiments of the present invention can be set on any side of the conduit 1 entering the transmission handle. For example, the buckling component can be set on the fixing part 4. In addition, the buckling component in the embodiments of the present invention can be any structure that can fix the conduit 1. Those skilled in the art can set it arbitrarily, and the present invention does not make any specific limitation.

[0049] In general, the transmission handle in this embodiment of the invention is mounted on the robotic arm 7 and controlled by the robotic arm 7. The transmission handle includes a rotation control component 2, a traction wire transmission cylinder 6, a fixing part 4, and a handheld part 3. The transmission handle designed by this invention can achieve precise control of the bidirectional bending, forward and backward pushing, and axial rotation of the catheter 1. Thus, under the guidance of the three-dimensional mapping system, precise control of the tip of the catheter 1 can be achieved, reducing the difficulty of the operation and improving the quality and efficiency of the operation.

[0050] In specific implementation, the rotary control component 2 in this embodiment of the invention includes: a first bevel gear 21 and a second bevel gear 22; wherein,

[0051] In this embodiment of the invention, the first bevel gear 21 is disposed at the head of the traction wire transmission cylinder 6. The first bevel gear 21 and the second bevel gear 22 rotate synchronously to drive the guide tube 1 to rotate axially.

[0052] In this embodiment of the invention, the second bevel gear 22 is rotatably connected to the first bevel gear 21. The second bevel gear 22 rotates to drive the first traction wire 16 or the second traction wire 17 to achieve bidirectional bending of the head end of the catheter 1.

[0053] That is, in the embodiment of the present invention, the first bevel gear 21 and the second bevel gear 22 are sequentially arranged at the head of the traction wire transmission cylinder 6, and then a hand-held part 3 is provided after the second bevel gear 22. The hand-held part 3 is sleeved on the outside of the traction wire transmission cylinder 6, and a fixing part 4 is provided at the end of the traction wire transmission cylinder 6. A fixing member 41 is provided on the fixing part 4.

[0054] See Figure 2 In specific implementation, the first bevel gear 21 and the traction wire drive cylinder 6 are locked in position to each other in this embodiment of the invention, and the second bevel gear 22 is screwed onto the outside of the traction wire drive cylinder 6. Furthermore, the second bevel gear 22 is provided with a limiting groove for connecting to the first bevel gear 21, and the limiting groove is used to restrict the radial movement of the second bevel gear 22.

[0055] With this configuration, the first bevel gear 21 and the second bevel gear 22 rotate synchronously to drive the catheter 1 to rotate axially, and the second bevel gear 22 rotates to drive the first traction wire 16 or the second traction wire 17, thereby achieving bidirectional bending of the catheter 1 tip.

[0056] See Figure 3 As can be seen, in this embodiment of the invention, the inner wall of the traction wire drive cylinder is provided with a position locking groove 64, which enables the first bevel gear 21 and the traction wire drive cylinder 6 to rotate synchronously along the axial direction.

[0057] Furthermore, the second bevel gear 22 in this embodiment of the invention is provided with an internal thread, which cooperates with the external thread 63 of the traction wire transmission cylinder 6 to ultimately realize the extension of the traction wire controlled by the second bevel gear 22.

[0058] Specifically, in this embodiment of the invention, the traction wire drive cylinder 6 is driven to move forward or backward by the synchronous rotation of the first bevel gear 21 and the traction wire drive cylinder 6, and by the rotation of the second bevel gear 22. Since one traction wire is directly fixed to the traction wire drive cylinder 6, while the other traction wire is fixed to the traction wire drive cylinder 6 after passing around the fixing member 41 on the fixing part 4, the above two transmission methods can achieve different control of the two traction wires, and finally control the bidirectional bending of the head of the conduit 1 by controlling the traction wire.

[0059] It should be noted that in the embodiments of the present invention, the fixing part 4 and the traction wire transmission cylinder 6 are connected by bypassing the traction wire on the fixing member 41. That is, the fixing part 4 and the traction wire transmission cylinder 6 are movably connected. In specific implementation, the fixing member 41 in the embodiments of the present invention can be a movable pulley or other structure. Those skilled in the art can make specific settings as needed. The embodiments of the present invention do not make specific limitations in this regard.

[0060] Specifically, in this embodiment of the invention, one end of the conduit 1 is embedded in a transmission handle. The transmission handle includes a first bevel gear 21, which is fixedly sleeved on the conduit 1. Rotation of the first bevel gear 21 can drive the conduit 1 to rotate circumferentially around its central axis, thereby achieving the purpose of rotating the conduit 1. The transmission handle also includes a second bevel gear 22. One end of the second bevel gear 22 is provided with a limiting groove for connecting to the first bevel gear 21. The limiting groove can restrict the radial movement of the second bevel gear 22. The second bevel gear 22 can rotate relative to the first bevel gear 21. A traction wire transmission cylinder 6 is threadedly connected to the inner wall of the second bevel gear 22. Rotation of the second bevel gear 22 can drive the threadedly connected traction wire transmission cylinder 6 to rotate. The moving cylinder 6 moves axially. One end of the traction wire drive cylinder 6 is symmetrically provided with a first connecting hole 61 and a second connecting hole 62 about its central axis. The first traction wire 16 connects to the first connecting hole 61. The second traction wire 17 passes through the traction wire drive cylinder 6, bypasses the fixing member 41 fixed to the fixing block, and returns to connect to the second connecting hole 62. Due to the presence of the fixing member 41, when the traction wire drive cylinder 6 moves, it will have opposite effects on the two traction wires. That is, when the traction wire drive cylinder 6 moves away from the deflectable section of the conduit 1, the first traction wire 16 tightens, and the second traction wire 17 loosens, causing the deflectable section of the conduit 1 to bend towards the side of the first traction wire 16, and vice versa, bending towards the side of the second traction wire 17, thus achieving bidirectional bending of the conduit 1. See details [link to documentation]. Figure 1-4 As shown.

[0061] In this embodiment of the invention, the measuring guide tube 1 can be mounted on the robotic arm 7 via a support 8. The support 8 is provided with a third bevel gear and a fourth bevel gear. After the transmission handle is mounted on the support 8, the bevel gears on the support 8 mesh with the bevel gears on the transmission handle. After the guide tube 1 is mounted on the robotic arm 7 via the support 8, the two output shafts of the robotic arm are inserted into the third bevel gear and the fourth bevel gear respectively and mesh with them. The robotic arm 7 controls the rotation of the first and second bevel gears 22 of the transmission handle by driving the third and fourth bevel gears to rotate, thereby realizing the rotation of the guide tube 1 and the bidirectional bending of the deflectable section. When controlling the rotation of the guide tube 1, the first and second bevel gears 22 must be rotated synchronously, that is, the second bevel gear 22 and the transmission handle must be kept relatively stationary. Otherwise, while the guide tube 1 is rotating, the guide tube 1 will bend synchronously. Therefore, the rotation of the guide tube 1 is controlled by rotating the first and second bevel gears 22 synchronously, and the bidirectional bending of the guide tube 1 is controlled by rotating the second bevel gear 22 alone. The pushing and retraction of the guide tube 1 is completed by moving the robotic arm 7 back and forth. The robot controls the entire robotic arm 7 to move back and forth to push and retract the conduit 1. The transmission handle can be connected to the robot platform and the movement of the conduit 1 can be controlled by the remote master control data processing system 9 to mark the target position.

[0062] See Figure 6-7 In this embodiment of the invention, catheter 1 is divided into an annular mapping section, a deflectable section, and a rigid catheter section. The annular mapping section is located at the tip of catheter 1, and the deflectable section is located posterior to the annular mapping section. A cross-sectional view of catheter 1 is shown below. Figure 8 As shown, the inner extension catheter of the catheter 1 is symmetrically provided with a first traction wire 16 and a second traction wire 17. The two traction wires are respectively connected to the end of the deflectable section away from the drive handle, and the other end of the two traction wires is connected to the drive handle.

[0063] The annular mapping section of the catheter is an open ring made of shape memory material. It is an open ring when there is no external force. The front end of the catheter 1 is also provided with a catheter sleeve 13. The length of the sleeve is greater than the length of the straightened annular mapping section. The sleeve is fitted on the catheter 1 and can slide along the axial direction of the catheter 1. The sleeve is used to straighten the annular mapping section at the head end of the catheter 1 and put it into the sleeve. Then the sleeve is connected to the robot's adjustable bending sheath, so that the annular mapping section enters and passes through the sheath in a straight strip shape, which facilitates the entry and passage of the annular mapping section of the mapping catheter through the sheath.

[0064] The annular mapping section has no fewer than 10 electrodes. It can be arranged in a ring with either a high density of 20 electrodes or a low density of 10 electrodes. The 20 electrodes can be paired into 10 pairs (with equal spacing between adjacent electrode pairs). In the lasso catheter 1, electrode distance can be divided into inter-electrode distance and bipolar distance. The inter-electrode distance is the distance between two adjacent electrodes, while the bipolar distance is the distance between two pairs of adjacent electrodes. The distance between electrodes within the same pair on the annular mapping section is 2 mm, and the bipolar distance is 5 mm. This closer proximity between the two electrodes within the same pair reduces signal averaging and cancellation effects, allowing for the recording of higher bipolar voltage amplitudes and shorter electrogram durations, thus achieving more accurate time annotation. The mapping catheter can then map faster and with higher accuracy. All 10 pairs of electrodes can collect electrophysiological signals and cardiac and blood impedance, enabling 3D modeling of the heart within the 3D mapping system. Figure 1-2 As shown, one end of the transmission handle is also equipped with a connection interface for the electrode signal line 5 of the catheter 1, which is used to electrically connect the electrode to the main control data processing system 9 and transmit the signal received by the electrode back to the main control data processing system 9. During mapping, the annular mapping section at the tip of the catheter moves along the endocardial wall, accurately recording the electrode position and corresponding electrocardiogram during this period. By moving the catheter 1, electrode information of new points is obtained, and three-dimensional anatomical maps are created or developed in real time to perform three-dimensional modeling of the heart.

[0065] See Figure 8 The number of electrodes on the annular measuring section is 10, and the electrodes are evenly arranged on the annular measuring section at a distance of 4mm.

[0066] In this embodiment of the invention, the annular mapping catheter 1 completes three-dimensional mapping of the heart chambers using a dielectric positioning system. The catheter 1 integrates high-density electrodes to acquire dielectric data. The dielectric three-dimensional positioning system transmits three 1 mA small currents through the chest by setting three pairs of skin electrodes in three orthogonal directions on the body. The frequency used in each direction is slightly different. A 30 kHz signal recorded from each electrode of catheter 1 can be digitally separated using a bandpass filter to measure the amplitude of each of the three frequency components. These three electric field strengths can be automatically calculated by measuring the amplitude differences between adjacent electrode pairs 11 using a known inter-electrode distance D, where the dipole region has ≥3 different spatial directions. The 3D position of each electrode is then calculated using the corresponding electric field strength.

[0067] Figure 5 This refers to a method of acquiring dielectric signals through electrodes in a single direction. For example... Figure 5 As shown, an externally applied 1 mA current at 30 kHz generates a voltage gradient across each component of the circuit. Under a fixed transthoracic current of 1 mA, voltage losses in the skin and lung regions do not affect the voltage drop across the entire heart. Moving catheter 1 from left to right records voltage changes from 150 mV to 160 mV. When current is applied externally through the chest, a voltage drop is generated between internal organs such as the heart. This voltage can be recorded using standard catheter electrodes. By measuring changes in dielectric parameters based on conductivity and capacitance constants from the electrodes, and combining this with the known distance between adjacent electrodes, the position of each electrode in 3D space is calculated.

[0068] The resolution of standard mapping catheter 1 is also affected by electrode size and electrode spacing. Due to large electrodes and wide electrode spacing, the spatial resolution of mapping catheters is limited. These catheters 1 can only record signals generated by relatively large tissue blocks, and are therefore more likely to exhibit large bipolar electrogram amplitudes. Furthermore, when recording with large electrodes, low-amplitude signals generated by smaller masses of living tissue may be lost. Therefore, while large areas of non-excitable scar tissue may be identified, small fibrotic chains containing arrhythmogenic matrix may escape detection against a background of high-amplitude far-field signals. Similarly, small strands of viable myocardium within dense scar areas may not be detectable during mapping. Smaller electrodes with closer electrode spacing record signals from smaller tissue blocks and are subject to less signal averaging and cancellation effects. Therefore, data acquisition using smaller electrodes can accurately monitor very small amplitude signals while limiting the influence of far-field signals and background noise. This is particularly advantageous in low-voltage areas and regions with uneven scar distribution.

[0069] Two additional visualization electrodes are located posterior to the annular mapping segment. These two visualization electrodes can be displayed within the 3D mapping system, allowing the operator to understand the relative position of the tip of the mapping catheter 1 and the tip of the sheath, as well as the orientation of the deflectable segment of the mapping catheter. This enables the operator to determine whether the annular mapping segment and the deflectable segment of the tip of the mapping catheter 1 have extended beyond the tip of the sheath. Since the annular mapping segment is made of shape memory material, it is easy to straighten and insert into the sheath. After the annular mapping segment extends beyond the tip of the sheath, when it is not constrained by external forces, it will revert to an open ring shape within the patient's body. After position adjustment, the target mapping position of the patient is mapped to complete the 3D modeling.

[0070] See Figure 9 The catheter 1 has a metal braided mesh 14 embedded inside. The metal braided mesh is disposed on the outer ring of the first traction wire 16 and the second traction wire 17, so that the body of the catheter 1 can withstand the reaction compressive load without deformation during the application of tension to the traction wire. In response to the change of rotation direction of the proximal part of the catheter 1, it can transmit torque from the proximal part of the catheter 1 to the distal part along the longitudinal axis of the catheter 1 to improve rotational fidelity. The outer diameter of the catheter 1 is no greater than 8Fr and is compatible with guide sheaths with a diameter of 8.5Fr or more.

[0071] The mapping catheter 1 is designed in four sections, from the tip to the rear: 1. Annular mapping section at the tip; 2. A deflectable section made of flexible material; 3. The main body of the catheter made of rigid material, with metal braided material embedded inside; 4. A drive handle.

[0072] See Figure 10 The surgeon sends control commands (specifically, these commands may include the three degrees of freedom of the catheter 1 and / or sheath) to the main control data processing system 9 through the doctor's control terminal 10. After receiving the commands from the doctor's control terminal 10, the main control data processing system 9 manipulates the remote robotic arm 7 to control the catheter 1 and sheath to perform corresponding surgical actions. The electrical signals are transmitted to the main control data processing system 9 through the electrodes on the annular mapping section of the mapping catheter 1. The main control data processing system 9 then processes the received electrical signals and converts them into image signals, which are displayed on the three-dimensional mapping and navigation system interface to complete the mapping of the target location.

[0073] In other words, the present invention uses the main control data processing system 9 to control the rotation control component 2 through the robotic arm 7, thereby pulling the first traction wire 16 or the second traction wire 17 to achieve bidirectional bending of the head end of the catheter 1 and axial rotation of the catheter 1, ultimately achieving the target mapping process.

[0074] The working process of the transmission handle of this invention is as follows:

[0075] 1. Move robotic arm 7 to the appropriate surgical position using the robotic arm support;

[0076] 2. Install the conduit support 8 onto the robotic arm 7, so that the two output shafts of the robotic arm 7 are respectively inserted into the third and fourth bevel gears of the conduit support 8 and mesh with the internal gears of the third and fourth bevel gears;

[0077] 3. Install the conduit onto the conduit support 8, so that the first and second bevel gears 22 mesh with the third and fourth bevel gears respectively;

[0078] 4. Close the hinge on the catheter support 8 to secure the catheter to the catheter support 8 on the robotic arm 7;

[0079] 5. Establishing intravascular catheter access using a sheath;

[0080] 6. Since the annular mapping section at the tip of the catheter is made of shape memory metal, the annular mapping section is first inserted straight into the sheath. The operator controls the doctor's end and uses the robotic arm 7 to advance the catheter within the catheter pathway until it moves out of the tip of the sheath. Without external force intervention, the annular mapping section returns to its open ring shape. The relative position of the catheter and the tip of the sheath is obtained through the two visual electrodes 12 at the rear end of the annular mapping section. After the catheter extends an appropriate distance out of the tip of the sheath, the advancement of the catheter is stopped.

[0081] 7. The operator controls the doctor's control terminal 10 and controls the circumferential rotation and bidirectional bending of the catheter through the robotic arm 7. The circular mapping section at the tip of the catheter is used to map the target position. The received electrical signals are transmitted back to the main control data processing system 9 through the electrodes on the circular mapping section. The main control data processing system 9 processes the received electrical signals and converts them into image information, which is displayed on the three-dimensional mapping navigation interface to complete the three-dimensional modeling of the heart.

[0082] 8. The surgeon performs ablation on the target location under the guidance of the three-dimensional mapping system;

[0083] 9. After ablation is completed, the operator moves the ring-shaped mapping segment to the ablation site using the doctor's end, re-maps the ablation site to check if there are still abnormal electrical signals, and marks the specific location. The operator then performs ablation on the same area again. If no abnormal electrical signals are transmitted, the ablation is considered successful.

[0084] Overall, this invention utilizes a robotic arm 7 to control the bidirectional bending, rotation, and axial pushing and retraction of the catheter, enabling precise control of the catheter tip movement, resulting in more stable catheter movement and higher mapping accuracy. Furthermore, the annular catheter tip of this invention is an open ring shape, and can be equipped with more than 20 high-density electrodes, arranged in pairs of more than 10 pairs. This not only increases the number of electrodes but also reduces the distance between electrodes within the same pair, minimizing signal averaging and cancellation effects. Therefore, it can record higher bipolar voltage amplitudes and shorter electrogram durations, achieving more accurate time annotation, faster catheter mapping speed, and higher mapping accuracy. Additionally, the catheter body of this invention incorporates metal braided material, improving rotational fidelity and enabling more precise control of catheter rotation. 4. The catheter can be bent bidirectionally, resulting in higher mapping efficiency and simpler, more convenient operation. Furthermore, this invention displays the distance the catheter travels from the tip of the guide sheath to the end of the guide sheath by setting two additional visualization electrodes at the rear of the catheter tip. This prevents operations from being performed before the catheter is fully extended from the guide sheath, as the sheath would interfere with the bending and rotating of the catheter.

[0085] Although preferred embodiments of the invention have been disclosed for illustrative purposes, those skilled in the art will recognize that various modifications, additions, and substitutions are possible, and therefore the scope of the invention should not be limited to the embodiments described above.

Claims

1. A transmission handle for controlling an annular dielectric calibration guide tube, characterized in that, The transmission handle is mounted on the robotic arm and includes: a rotation control assembly, a traction wire transmission cylinder, a fixing part, and a handheld part. A guide tube enters from the head of the traction wire transmission cylinder and connects to a signal line at the end of the traction wire transmission cylinder. The rotation control assembly is fixed to one side of the head of the traction wire transmission cylinder. The fixing part is located on the guide tube at the end of the traction wire transmission cylinder. The handheld part is sleeved around the traction wire transmission cylinder for gripping. The catheter is symmetrically embedded with a first traction wire and a second traction wire, wherein the first end of the first traction wire and the first end of the second traction wire are both located at a preset position at the head of the catheter, and the second end of the first traction wire and the second end of the second traction wire are both connected to the end of the traction wire transmission cylinder. Based on the control of the robotic arm, with the cooperation of the rotary control component and the traction wire drive cylinder, the rotary control component pulls the first traction wire or the second traction wire to achieve bidirectional bending of the catheter tip, and the axial rotation of the catheter is achieved by controlling the rotary control component, ultimately realizing the target mapping process; The rotary control assembly includes: a first bevel gear and a second bevel gear; The first bevel gear is disposed at the head of the traction wire drive cylinder, and the first bevel gear and the second bevel gear rotate synchronously to drive the guide tube to rotate axially; The second bevel gear is rotatably connected to the first bevel gear. The rotation of the second bevel gear drives the first traction wire or the second traction wire to achieve bidirectional bending of the catheter tip. The end of the traction wire drive cylinder is provided with a first connecting hole and a second connecting hole. The first traction wire is fixed to the first connecting hole, and the second traction wire passes around the reversing pulley on the fixed part and is fixed to the second connecting hole, so that the rotation of the second bevel gear in different directions can pull the first traction wire or the second traction wire to achieve bending of the catheter tip in different directions. The synchronous rotation of the first bevel gear and the traction wire drive cylinder, and the rotation of the second bevel gear, drive the traction wire drive cylinder to move forward or backward. Thus, different control of the first and second traction wires is achieved through two transmission methods. When the traction wire drive cylinder moves, it will have opposite effects on the first and second traction wires, causing the deflectable section of the guide tube to bend towards the first traction wire and vice versa. The fixed part and the traction wire drive cylinder are connected by the traction wire that passes around the fixed part, and the fixed part and the traction wire drive cylinder are movably connected; The transmission handle is fixed to the robotic arm by a support, which is provided with a third bevel gear and a fourth bevel gear. The third bevel gear meshes with the first bevel gear, and the fourth bevel gear meshes with the second bevel gear. The control commands on the robotic arm are transmitted to the rotary control assembly via the third and fourth bevel gears.

2. The transmission handle according to claim 1, characterized in that, The inner wall of the traction wire drive cylinder is provided with a position locking groove, which enables the first bevel gear and the traction wire drive cylinder to rotate synchronously along the axial direction. The second bevel gear is screwed onto the outside of the traction wire drive cylinder.

3. The transmission handle according to claim 2, characterized in that, The second bevel gear is provided with a limiting groove for connecting with the first bevel gear, and the limiting groove is used to restrict the radial movement of the second bevel gear.

4. The transmission handle according to any one of claims 1-3, characterized in that, The conduit is secured within the transmission handle by a snap fastener.

5. The transmission handle according to any one of claims 1-3, characterized in that, The head of the catheter is provided with an annular mapping section with a ring-shaped opening, and the annular mapping section is made of shape memory material and has more than 10 mapping electrodes.

6. The transmission handle according to any one of claims 1-3, characterized in that, The catheter is embedded with a metal braided mesh, which is located on the outer side of the first traction wire and the second traction wire in the radial direction.

7. The transmission handle according to any one of claims 1-3, characterized in that, The robotic arm is connected to the main control data processing system, which controls the rotary control component through the robotic arm to pull the first traction wire or the second traction wire to achieve bidirectional bending of the catheter tip, ultimately realizing the target mapping process.

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