A dual-curve robotic electrophysiology guide sheath

Abstract

This invention provides a double-bend robotic electrophysiological guidance sheath, comprising a sheath tube and a control assembly. A first traction wire and a second traction wire are symmetrically arranged within the sheath tube, respectively connected to the sheath tube and the control assembly. The control assembly pulls either the first or second traction wire, achieving bidirectional bending of the sheath tube. The control assembly can be connected to a robotic arm, which controls the sheath tube to the target surgical position, enabling circumferential rotation, bidirectional bending, and axial movement of the sheath tube, making the surgical procedure safer and more efficient.

Description

Technical Field

[0001] This invention relates to the field of medical ablation surgical instruments, and more particularly to a double-bend robotic electrophysiological guidance sheath. Background Technology

[0002] Atrial fibrillation is one of the more common arrhythmias in clinical practice, and its incidence has increased significantly in recent years. Treatment mainly focuses on controlling the ventricular rate and restoring sinus rhythm. Electrode catheters have been widely used in medical practice for many years. They are used to stimulate and map electrical activity in the heart and ablate abnormal activity sites. Catheter-guided radiofrequency ablation is a new method developed in recent years for treating various types of arrhythmias, and its effects are more pronounced than drug therapy. There are various methods of radiofrequency ablation, but regardless of the method used, the procedure must be performed within the atrium. First, a channel needs to be constructed within the blood vessel to reach the target lesion within the heart chambers through a sheath. The ablation catheter passes through the sheath to the target ablation site and ablates the lesion. Therefore, the operator needs to precisely position the sheath. Traditional guide sheaths are difficult to operate, have poor stability and precision, and bring many inconveniences to the procedure.

[0003] Currently, traditional sheaths used in clinical practice require the operator to manually guide them into the lesion location within the heart chamber under fluoroscopic or 3D imaging guidance after insertion into the blood vessel. This results in poor sheath stability and precision. Traditional sheaths lack bending capabilities or can only be bent in one direction. After entering the heart chamber, the sheath cannot accurately reach the target lesion location and can only be pushed axially. Most traditional sheaths have an arc-shaped tip, and the position of the tip can only be adjusted by rotating the sheath to get as close as possible to the target ablation site. Traditional sheaths require a 180° rotation to turn the tip to the other side, which is a large range of motion. Because the tip of the sheath is arc-shaped, it is easily limited by the size of the space within the heart chamber, especially in some narrow areas where it is impossible to complete the 180° turn of the arc-shaped tip of the sheath. Traditional unidirectional bending sheaths require straightening the sheath first, rotating it 180° in the second step, and finally bending it to the target lesion. Although it can achieve the goal, the operation is cumbersome and inefficient. Traditionally, the pushing, rotating, and bending of the sheath are all done manually by the surgeon. It is impossible to precisely control the variables of pushing, rotating, and bending. The surgeon can only control the sheath by feeling, resulting in poor surgical precision and high requirements for the surgeon's professional skills. During manual operation, factors such as doctor fatigue and unstable operation can easily affect the safety of the operation, especially the risk of cardiac perforation leading to cardiac tamponade during the operation.

[0004] In related art, a deflectable guide is disclosed, comprising: a shaft having a deflectable portion and an inner cavity through which a conduit can extend; a control drive handle; and first and second tension members extending from the control drive handle to the deflectable portion and returning to the control drive handle. The control drive handle has a deflection assembly of a deflection member and a rotatable member, the deflection member being rotatable about an axis generally perpendicular to the longitudinal axis of the control drive handle. The rotatable member has a first pulley engaging with a first proximal portion of the tension member located within the control drive handle, and a second pulley engaging with a second proximal portion of the tension member located within the control drive handle. Manipulating the deflection member in one direction attracts the first proximal portion of the tension member to deflect the deflectable portion of the shaft in that direction, and manipulating the deflection member in another direction pulls up the second proximal portion of the tension member to deflect the deflectable portion of the shaft in that other direction.

[0005] In the above-mentioned technical solution, the tensioning member extends from the control transmission handle to the deflectable part and loops back into the control transmission handle. The deflection of the deflectable part at the distal end of the sheath is controlled by the rotating member and the tensioning member. Although this method can achieve bidirectional deflection of the sheath, it cannot precisely control the amount of deflection. The deflection of the sheath still needs to be manually controlled, resulting in low surgical precision and a relatively cumbersome process. Summary of the Invention

[0006] This invention addresses the technical problems of instability in manual sheath operation and low precision in bidirectional bending of the sheath. It provides a bidirectional bending robotic electrophysiological guidance sheath that allows for precise control of the sheath through robotic control of bidirectional bending, rotation, and forward / backward movement, making the surgical procedure safer and more efficient.

[0007] This invention provides a double-bend robotic electrophysiological guidance sheath, comprising a sheath tube and a control assembly. The sheath tube contains a first traction wire and a second traction wire, which are respectively connected to the sheath tube and the control assembly. The control assembly pulls the first or second traction wire to achieve bidirectional bending of the sheath tube. The control assembly can be connected to a robotic arm, which controls the sheath tube to the target surgical position, enabling circumferential rotation, bidirectional bending, and axial movement of the sheath tube.

[0008] According to some embodiments of the present invention, the sheath includes a flexible segment and a rigid segment, wherein the flexible segment of the sheath can be bent after entering the target lesion; the rigid segment of the sheath is provided with a control component, which can control not only the bending of the flexible segment but also the axial rotation of the sheath. The control component of the rigid segment of the sheath does not enter the body.

[0009] According to some embodiments of the present invention, multiple electrodes are spaced apart along the axial direction of the flexible segment of the guide sheath to determine the spatial position and shape of the flexible segment. Electrode signal transmission lines are disposed within the sheath body.

[0010] According to some embodiments of the present invention, the control assembly includes: a first control part and a second control part, through which a sheath passes. The first control part is fixedly sleeved on the sheath and can drive the sheath to rotate circumferentially or move axially; the second control part is rotatably connected to the first control part and is used to control the bending of the sheath.

[0011] According to some embodiments of the present invention, the first control unit includes a first bevel gear, which is fixedly sleeved on the sheath tube. When the first bevel gear rotates, it drives the sheath tube to rotate circumferentially or move axially around the central axis.

[0012] According to some embodiments of the present invention, the second control unit includes a second bevel gear, a connecting cylinder, and a fixing block. The second bevel gear is rotatably connected to the first bevel gear. The second bevel gear is provided with a locking groove to restrict the radial movement of the second bevel gear relative to the first bevel gear. The connecting cylinder is connected to the internal thread of the second bevel gear via an external thread, and the connecting cylinder is also movably connected to the first control unit via a limiting groove. The fixing block is disposed near the connecting cylinder and fixedly sleeved on the end of the sheath tube.

[0013] According to some embodiments of the present invention, a first connecting hole and a second connecting hole are symmetrically arranged at the end of the connecting tube, and a reversing pulley is provided on the fixing block; the first end of the first traction wire inside the sheath is fixed at the first port of the sheath head, and the second end of the first traction wire is fixed at the first connecting hole of the connecting tube; the first end of the second traction wire is fixed at the second port of the sheath head, and the second end of the second traction wire passes around the reversing pulley and connects to the second connecting hole of the connecting tube. When the second bevel gear rotates, it can drive the connecting tube to move axially, thereby pulling the first traction wire or the second traction wire, realizing bidirectional bending of the sheath head.

[0014] According to some embodiments of the present invention, an ablation catheter is inserted into the sheath, and a three-way connector is installed on the sheath. The output channel of the three-way connector is connected to the channel of the ablation catheter, thereby injecting medical solvent into the channel of the ablation catheter.

[0015] According to some embodiments of the present invention, the guide sheath is embedded with a metal braided mesh, which is located radially outside the first traction wire and the second traction wire.

[0016] According to some embodiments of the present invention, the robotic arm is provided with a sheath support, the sheath support having a third bevel gear meshing with a first bevel gear and a fourth bevel gear meshing with a second bevel gear.

[0017] This invention enables bidirectional bending of the sheath by setting a control component, a first traction wire, and a second traction wire in the guide sheath. Furthermore, by providing a sheath support on the robotic arm to connect to the guide sheath, the invention completes the forward and backward pushing, rotation, and bidirectional bending of the sheath, thereby improving surgical precision and safety. Attached Figure Description

[0018] Figure 1 This is an overall structural diagram of the electrophysiological guidance sheath for a double-bend robot according to an embodiment of the present invention;

[0019] Figure 2 This is a schematic diagram of the cross-section of the electrophysiological guidance sheath of the double-bend robot according to an embodiment of the present invention;

[0020] Figure 3 This is a schematic diagram of the operation of the electrophysiological guidance sheath of the double-bend robot according to an embodiment of the present invention;

[0021] Figure 4 This is a diagram showing the internal structure of the electrophysiological guidance sheath for a double-bend robot according to an embodiment of the present invention.

[0022] Figure 5 This is an enlarged view of the internal structure of the connecting portion of the electrophysiological guidance sheath of the double-bend robot according to an embodiment of the present invention;

[0023] Figure 6 This is a schematic diagram of the bending of the flexible segment of the sheath of the double-bend robot electrophysiological guidance sheath according to an embodiment of the present invention;

[0024] Figure 7 This is a diagram showing the internal structure of the second conical gear of the electrophysiological guidance sheath for a double-bend robot according to an embodiment of the present invention.

[0025] Figure Labels

[0026] Guiding sheath 100,

[0027] Sheath 10, metal braided mesh 110, electrode 120, electrode signal transmission line 121, tee connector 130.

[0028] Control component 20,

[0029] First control unit 210, first bevel gear 211, first limit block 212

[0030] The system includes a second control unit 220, a second bevel gear 221, an internal thread 2210 on the second bevel gear, a connecting cylinder 222, an external thread 2220 on the connecting cylinder, a first connecting hole 2221, a second connecting hole 2222, a limiting groove 2223, a fixing block 224, and a reversing pulley 2240.

[0031] First traction wire 30, second traction wire 40, ablation catheter 50.

[0032] Robotic arm 60, sheath support 610,

[0033] Operating table 70, main control data processing system 80, doctor control terminal 90. Detailed Implementation

[0034] To further illustrate the technical means and effects of the present invention in achieving its intended purpose, the present invention will be described in detail below with reference to the accompanying drawings and preferred embodiments.

[0035] like Figure 1 As shown in Figure 2, the bi-bending robotic electrophysiological guidance sheath 100 according to an embodiment of the present invention includes a sheath tube 10 and a control component 20. A first traction wire 30 and a second traction wire 40 are symmetrically arranged inside the sheath tube 10. As shown in Figure 2, the first traction wire 30 and the second traction wire 40 are respectively connected to the sheath tube 10 and the control component 20. The control component 20 pulls the first traction wire 30 or the second traction wire 40 to achieve bi-directional bending of the sheath tube 10.

[0036] Control component 20 can be connected to robot arm 60, such as Figure 3 As shown, the robotic arm 60 controls the sheath 10 to the target surgical position, realizing the circumferential rotation, bidirectional bending and axial movement of the sheath 10.

[0037] In the doctor's control room, the main control data processing system 80 receives and processes the position signal of the sheath 10 tip. This position signal is then displayed on the 3D navigation interface screen for the doctor to view in real time. Based on the sheath 10 tip position signal, the doctor sends control commands to the main control data processing system 80 via the doctor's control terminal 90. The main control data processing system 80 then manipulates the robotic arm 60 in the operating room to control the guide sheath 100 to perform corresponding surgical actions. This invention allows the doctor to remotely operate the robotic arm from the doctor's control room to move, bend, or rotate the sheath 10, greatly improving surgical precision and safety.

[0038] According to some embodiments of the present invention, the sheath 10 includes a flexible segment and a rigid segment, wherein the flexible segment of the sheath 10 can be bent after entering the target lesion. Figure 6 The diagram shows the flexible segment of the sheath 10 bent at 270°, 0°, and -270°. A control component 20 is provided on the rigid segment of the sheath 10, which can control not only the bending of the flexible segment but also the axial rotation of the sheath 10. The control component 20 for the rigid segment of the sheath 10 does not enter the body.

[0039] According to some embodiments of the present invention, a plurality of electrodes 120 are provided at intervals in the axial direction of the flexible segment of the sheath 10. Figure 6The diagram illustrates a configuration where four electrodes 120 are evenly spaced along the flexible segment of the sheath 10. This configuration allows for the determination of the spatial position and shape of the flexible segment as it bends to varying degrees. The arrangement of the four electrodes 120 not only reveals the specific location of the flexible segment but also displays the bending and rotation of the sheath 10's tip, facilitating better control of the sheath 10. The electrode signal transmission lines 121 of the electrodes 120 are integrated within the sheath 10 body. Figure 2 As shown. Electrode 120 can feed back electrical signals to the main control data processing system 80. The main control data processing system 80 then processes the received signals and displays them on the three-dimensional navigation interface display screen. The doctor can then understand the spatial position information of the sheath 10 in the patient's body, effectively ensuring the safety of the surgical operation.

[0040] According to some embodiments of the present invention, the control assembly includes: a first control part 210 and a second control part 220, through which the sheath 10 passes. The first control part 210 is fixedly sleeved on the sheath 10 and can drive the sheath 10 to rotate circumferentially or move axially; specifically, the first control part 210 is fixedly sleeved on the rigid section of the sheath 10. The second control part 220 is rotatably connected to the first control part 210 and is used to control the bending of the sheath 10.

[0041] According to some embodiments of the present invention, the first control unit 210 includes a first bevel gear 211, which is fixedly sleeved on the sheath tube 10. When the first bevel gear 211 rotates, it drives the sheath tube 10 to rotate circumferentially or move axially around the central axis. Figure 1 As shown, the first control unit 210 may also include a first limiting block 212, which is fixedly connected to the sheath tube 10. The first bevel gear 211 is fixedly connected to the first limiting block 212, and when the first bevel gear 211 rotates, it drives the sheath tube 10 to rotate circumferentially or move axially around the central axis through the first limiting block 212.

[0042] According to some embodiments of the present invention, the second control unit 220 includes a second bevel gear 221, a connecting cylinder 222, and a fixing block 224. The second bevel gear 221 is rotatably connected to the first bevel gear 211. The second bevel gear 221 is provided with a locking groove to restrict radial movement of the second bevel gear 221 relative to the first bevel gear 211. The connecting cylinder 222 is connected to the internal thread 2210 of the second bevel gear 221 via an external thread 2220, and the connecting cylinder 222 is also movably connected to the first control unit 210 via a limiting groove 2223. The fixing block 224 is disposed near the connecting cylinder 222 and fixedly sleeved on the end of the sheath tube 10. Figure 5 As shown.

[0043] The limiting groove 2223 of the connecting cylinder 222 can be movably connected to the first bevel gear 211 or the first limiting block 212. Specifically, a protruding device that can extend into the limiting groove 2223 is provided at the end of the first bevel gear 211 or the end of the first limiting block 212. The length of the protruding device should ensure that the protruding device is always kept in the limiting groove 2223 when the connecting cylinder 222 moves axially.

[0044] When the first bevel gear 211 and the second bevel gear 221 remain relatively stationary and rotate synchronously, they can drive the sheath 10 to rotate synchronously. When the first bevel gear 211 remains stationary and the second bevel gear 221 rotates relative to the first bevel gear 211, the sheath 10 remains stationary. Rotation of the second bevel gear 221 will cause axial movement of the connecting cylinder 222, but the presence of the limiting groove 2223 of the connecting cylinder 222 restricts its rotation. It should be noted that since the connecting cylinder 222 is movably connected to the first limiting block 212 of the first control unit 210 or the protrusion on the first bevel gear 211 via the limiting groove 2223, the axial movement of the connecting cylinder 222 will not affect the axial movement of the sheath 10; that is, under the aforementioned rotational conditions, the sheath 10 will not move axially.

[0045] As described above, whether the second bevel gear 221 rotates or not does not affect the stationary or rotating state of the sheath 10. In the absence of other forces, the stationary or rotating state of the sheath 10 is controlled by the first bevel gear 211 or the first control unit 210.

[0046] According to some embodiments of the present invention, the connecting cylinder 222 is provided with a first connecting hole 2221 and a second connecting hole 2222 at its end, and the fixing block 224 is provided with a reversing pulley 2240, such as Figure 5 As shown, the first end of the first traction wire 30 inside the sheath 10 is fixed at the first port of the sheath 10 head end, and the second end of the first traction wire 30 is fixed at the first connecting hole 2221 of the connecting cylinder 222; the first end of the second traction wire 40 is fixed at the second port of the sheath 10 head end, and the second end of the second traction wire 40 passes around the reversing pulley 2240 and connects to the second connecting hole 2222 of the connecting cylinder 222. When the second bevel gear 221 rotates, it can drive the connecting cylinder 222 to move axially, thereby pulling the first traction wire 30 or the second traction wire 40, realizing bidirectional bending of the head end of the sheath 10.

[0047] Specifically, such as Figure 4 As shown, when the connecting tube 222 moves away from the flexible section of the sheath tube 10, the first traction wire 30 tightens and the second traction wire 40 loosens, causing the flexible section of the sheath tube 10 to bend towards the side of the first traction wire 30, and vice versa, to bend towards the side of the second traction wire 40, thereby achieving bidirectional bending of the sheath tube 10.

[0048] According to some embodiments of the present invention, an ablation catheter 50 is inserted into the sheath 10. The ablation catheter 50 enters the sheath 10 from the rear end of the rigid segment of the sheath 10, passes through the sheath 10, and directly reaches the target lesion location for ablation treatment. A three-way connector 130 is installed on the sheath 10, and the output channel of the three-way connector 130 communicates with the channel of the ablation catheter 50, thereby injecting saline, heparin anticoagulant, or cardiac contrast agent into the channel of the ablation catheter 50. The saline is mainly used for lubrication between the catheter and the sheath 10, while the heparin anticoagulant or cardiac contrast agent is mainly used for treatment of the target lesion. A hemostatic valve is built into the sheath 10.

[0049] According to some embodiments of the present invention, the guide sheath 100 sheath tube 10 is embedded with a metal braided mesh 110, which is located radially outside the first traction wire 30 and the second traction wire 40, such that the body of the sheath tube 10 can withstand the reaction compressive load without deformation during the tension applied by the traction wire, and in response to the change of the rotation direction of the flexible section of the sheath tube 10, torque can be transmitted along the longitudinal axis of the sheath tube 10 from the proximal portion to the distal portion to improve rotational fidelity.

[0050] According to some embodiments of the present invention, the robotic arm 60 is provided with a sheath support 610. The sheath support 610 is provided with a third bevel gear meshing with a first bevel gear 211 and a fourth bevel gear meshing with a second bevel gear 221. After the guide sheath 100 is mounted on the robotic arm 60 via the sheath support 610, the two output shafts of the robotic arm 60 are respectively inserted into and meshed with the third and fourth bevel gears. The robotic arm 60 controls the rotation of the first bevel gear 211 and the second bevel gear 221 of the sheath 10 by driving the third and fourth bevel gears to rotate, thereby realizing the rotation of the sheath 10 and the bidirectional bending of the deflectable section. The pushing and retraction of the sheath 10 is accomplished by the robot controlling the forward and backward movement of the entire robotic arm 60.

[0051] When controlling the rotation of the sheath 10, the first bevel gear 211 and the second bevel gear 221 must be rotated synchronously, that is, the second bevel gear 221 and the first bevel gear 211 must be kept relatively stationary. Otherwise, the sheath 10 will bend synchronously while rotating. Therefore, the rotation of the sheath 10 is controlled by rotating the first bevel gear 211 and the second bevel gear 221 synchronously, and the bidirectional bending of the sheath 10 is controlled by rotating the second bevel gear 221 alone. The pushing and retracting of the sheath 10 is completed by moving the entire robotic arm 60 back and forth.

[0052] Through the description of specific embodiments, a more in-depth and specific understanding should be gained of the technical means and effects adopted by the present invention to achieve the intended purpose. However, the accompanying drawings are only provided for reference and illustration and are not intended to limit the present invention.

Claims

1. A double-bend robotic electrophysiological guidance sheath, characterized in that, The guide sheath includes a sheath tube and a control component. The sheath tube contains a first traction wire and a second traction wire. The first traction wire and the second traction wire are respectively connected to the sheath tube and the control component. The control component pulls the first traction wire or the second traction wire to achieve bidirectional bending of the sheath tube. The control component includes: The first control unit includes a first bevel gear fixedly sleeved on the sheath tube. When the first bevel gear rotates, it can drive the sheath tube to rotate circumferentially around its central axis. The second control unit, rotatably connected to the first control unit, includes a second bevel gear, a connecting cylinder, and a fixing block; the second bevel gear is rotatably connected to the first bevel gear; the connecting cylinder is externally threaded to the internal thread of the second bevel gear and movably connected to the first control unit through a limiting groove, so that the connecting cylinder can move axially but cannot rotate; the fixing block is fixedly sleeved on the proximal end of the sheath. The connecting cylinder has a first connecting hole and a second connecting hole symmetrically arranged at its end, and the fixing block is provided with a reversing pulley; the second end of the first traction wire is fixed to the first connecting hole, and the second end of the second traction wire passes around the reversing pulley and is fixed to the second connecting hole; The control component is adapted to be connected to the sheath support of the robotic arm, and the robotic arm controls the sheath to the surgical target position, and realizes the circumferential rotation, bidirectional bending and axial movement of the sheath; The sheath support is provided with a third bevel gear that meshes with the first bevel gear and a fourth bevel gear that meshes with the second bevel gear. By driving the third bevel gear and / or the fourth bevel gear with the robotic arm, the following operations can be achieved: The first and second bevel gears are driven to rotate in the same direction and at the same speed, causing the sheath to rotate around the central axis while maintaining its curved shape. The second bevel gear is driven to rotate independently, and the first traction wire or the second traction wire is pulled by the axial movement of the connecting cylinder to achieve bidirectional bending of the distal end of the sheath. The axial advancement or retraction of the sheath is achieved through the overall movement of the robotic arm.

2. The double-bend robotic electrophysiological guidance sheath as described in claim 1, characterized in that, The sheath includes: Flexible segment, wherein the flexible segment is bendable; A rigid segment, on which the control component is provided.

3. The double-bend robot electrophysiological guidance sheath as described in claim 2, characterized in that, Multiple electrodes are spaced apart along the axial direction of the flexible sheath segment to determine its spatial position and shape.

4. The double-bend robotic electrophysiological guidance sheath as described in claim 1, characterized in that, An ablation catheter is inserted into the sheath, and the sheath is equipped with a three-way connector. The output channel of the three-way connector is connected to the ablation catheter channel to inject medical solvent into the ablation catheter channel through the three-way connector.

5. The double-bend robotic electrophysiological guidance sheath as described in any one of claims 1 to 4, characterized in that, The sheath is embedded with a metal braided mesh, which is located radially outside the first traction wire and the second traction wire.

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