CN117771510A - Steering system for interventional operation - Google Patents

Abstract

The invention relates to a steering system for interventional operation, and belongs to the technical field of medical appliances. The steering system comprises a steering device for guiding the catheter to change the advancing direction, and the steering device comprises a first rotating shaft arranged along the radial direction of the interventional tube cavity and a second rotating shaft arranged along the radial direction of the interventional tube cavity and perpendicular to the first rotating shaft; the front and rear side guide pipes of the steering device are respectively provided with a distal end section connected with the second rotating shaft and a proximal end section connected with the first rotating shaft; the steering device is provided with a first driving device for driving the first rotating shaft, the second rotating shaft and the distal end section to axially rotate around the central shaft of the first rotating shaft; the steering device is also provided with a second driving device for driving the second rotating shaft and the distal end section to axially rotate around the central shaft of the second rotating shaft. The steering information of the guide wire catheter can be accurately obtained through the angle sensors arranged on the first rotating shaft and the second rotating shaft, so that a hardware basis is provided for realizing more accurate and easier intervention operation and reducing the dependence on the actual experience value of an operator.

Description

A steering system for interventional surgery

Technical field

The invention relates to a steering system for interventional surgery and belongs to the technical field of medical devices.

Background technique

One of the current means of treating cardiovascular diseases is to open blood vessels using guidewires, catheter-delivered stents, etc. This type of interventional surgery mainly relies on skilled doctors to complete the interventional operation of surgical instruments such as catheters, guidewires, microcatheters and balloons in a manual manner under the monitoring and guidance of X-rays or other devices that can provide grayscale images. The blood vessels in the human body are characterized by being curved, narrow, irregular, and having many branches. There are certain risks when doctors perform such interventional operations. The operation is complicated, the operation time is long, and there are many factors that affect the quality of the operation. The success of the operation depends largely on the experience of the specific operator. Conventional guidewires or catheters are soft, slender strip-shaped components that can usually be manipulated from outside the body in two degrees of freedom (axial push and pull and axial rotation). The operator navigates the head end of these instruments to the target position through axial and radial manipulation. At present, one of the main challenges in cardiovascular or intravascular interventional surgery is the manipulation and navigation of the guidewire. For this type of surgery, it is particularly important to have an accurate and reliable control device to guide the guide wire to adapt to the changes in the shape and direction of the human anatomical structure; there are many technical solutions in the prior art that have made various attempts, such as Chinese patents, application number "202211223827.X", application number "202011132124.7", etc., by adding active or passive mechanisms to the guide wire and catheter to enhance the steering ability of such devices. Common methods include increasing the steering ability of the head end by incorporating a pull wire connected to the head end of the device into the device; connecting the main catheter shaft comprising a higher hardness material to the distal section comprising a lower hardness material. This difference in material composition ensures that manipulation of the wire will first manipulate the distal tip. Bending of the distal end relative to the main axis can be achieved by applying a pulling force to the pull wire: the pulling force is parallel but offset relative to the main axis of the device.

In the prior art, the method of adding a pull wire is widely used in steerable catheters and steerable guidewires, and allows multiple degrees of freedom of movement control of the tip of the device. For example, the Chinese patent application number is "201980029400.6". However, this type of method in the existing technology still has shortcomings in terms of precise tracking and ease of operation: through wire steering, the end steering angle cannot be accurately known, and monitoring of image equipment is still required. Manual and uninterrupted correction operations are carried out, and such correction operations often rely heavily on the doctor's personal experience; multiple pull wires are used, and multiple pull wires are concentrated outside the body, and each pull wire needs to be pushed and pulled separately when turning. The operation increases the complexity of the specific operator's operation and is prone to misoperation. In recent years, with the development of robotic technology, vascular interventional surgical robots have also developed rapidly as an emerging industry in the field of minimally invasive vascular interventional surgery. The main working process of the minimally invasive vascular interventional surgery robot is as follows: with the help of the imaging module, the doctor operates the operating module and uses the execution module to perform actions on the microcatheter/guidewire instead of the doctor according to the doctor's instructions. The use of minimally invasive vascular interventional surgery robots can make the operation more precise and shorten the operation time. It can also avoid the physical fatigue and injuries caused by doctors wearing heavy lead suits and receiving X-rays. This also puts forward new demands for the head-end steering method of interventional surgical devices. This technical field urgently needs to obtain a new steering mechanism and navigation method to meet the needs of surgeons or surgical robots to accurately obtain guidewire catheter steering information. Achieve more accurate and easier operation, reduce dependence on the operator's actual experience value, and overcome the shortcomings of the existing technology.

Contents of the invention

The purpose of the present invention is to solve how to obtain a new steering mechanism and navigation method to meet the needs of surgeons or surgical robots to accurately obtain guidewire catheter steering information, achieve more accurate and easier operations, and reduce the actual impact on the operator. Technical issues with experience value dependence.

In order to achieve the purpose of solving the above problems, the technical solution adopted by the present invention is to provide a steering device for interventional surgery. The head section of the interventional instrument is provided with a steering device for guiding the instrument to change its forward direction.

The steering device comprises a first rotating mechanism and a second rotating mechanism; the first rotating mechanism is provided with a first rotating shaft along the radial direction of the cross section of the intervention lumen, and the second rotating mechanism is provided with a second rotating shaft along the radial direction of the cross section of the intervention lumen; the second rotating shaft is vertically connected to the first rotating shaft;

The front and rear ends of the steering device along the interventional operation direction are respectively set as a distal section away from the operator and a proximal section close to the operator; the distal section is connected to the rotating shaft; the proximal section is connected to the rotating shaft. Shaft one connection;

The steering device is provided with a driving device for driving the rotation axis one, the rotation axis two and the distal section to rotate axially around the central axis of the rotation axis one; the steering device is also provided with a driving device for driving the rotation axis two and the distal section to rotate around The central shaft of the second shaft rotates axially in the driving device two.

Preferably, the interventional instrument comprises a catheter or a microcatheter.

Preferably, the steering device is provided at the end of a microcatheter, the microcatheter is inserted into an interventional catheter, and a guidewire is provided in the microcatheter; the front and rear sides of the steering device along the interventional direction are The microcatheters are respectively provided with a distal section far away from the operator and a proximal section close to the operator; the distal section is connected to the second rotation shaft; the proximal section is connected to the first rotation shaft.

Preferably, a retractable elastic catheter is provided between the distal section and the proximal section.

Preferably, the rotating shaft 1 is provided with a gear 1 for driving the rotating shaft 1 to rotate around a central axis of the rotating shaft 1.

Preferably, a rotating shaft is passed through the shaft body of the rotating shaft one, and the rotating shaft is perpendicular to the rotating shaft two; the rotating shaft two is perpendicularly arranged on the shaft body of the rotating shaft one, and one end of the rotating shaft two is meshedly connected with one end of the rotating shaft through a gear.

Preferably, the rotating shaft is provided with a second gear for driving the rotating shaft to rotate around a central axis of the rotating shaft.

Preferably, the gear one and the gear two are provided with pull wires for pulling the gears to rotate.

The present invention provides a steering system for interventional surgery. The steering system includes the above-mentioned steering device; and the first rotation axis and the second rotation axis are provided with angle sensors.

Preferably, the steering system comprises a software module for calculating the rotation angle of the intervention object through data of the rotation angles of the first rotation axis and the second rotation axis, and a software module for simulating the rotation angle of the intervention object in a virtual human body in vitro.

Compared with the existing technology, the present invention has the following beneficial effects:

1. The present invention achieves the purpose of large-scale steering of interventional instruments during interventional surgery.

2. The present invention uses an external wire pulling operation to rotate the first and second rotating shafts, and through the external monitoring imaging system, it is easier to grasp the angle and steering direction of the interventional instrument; it reduces the actual need for repeated attempts in the steering operation in the prior art. The time and risk taken; reduce the current situation that the success of the turn depends greatly on the actual experience of the specific operator.

3. In the rotating device of the present invention, the rotating axis one and the rotating axis two are connected through gear transmission, which is a mechanical hard connection, so that the relative positions between the rotating axis one, the rotating axis two and the intervening catheter are clear; and then the angle sensor is provided to make The rotation angles of the first and second rotating axes can be monitored, which meets the needs of surgeons or surgical robots to accurately obtain guidewire catheter steering information. In order to achieve more accurate and easier interventional operations, it also reduces the need for the operator's actual experience value. Dependencies provide the hardware foundation.

4. The present invention reduces the number of pull wires. In practical applications, the pull wires that control the rotation of the first or second rotation axis can be connected in a ring shape outside the body. When turning, you only need to pull the two pulling wires forward or reverse to complete the work of controlling the rotation of the first or second rotating axis, making the operation more convenient.

Description of drawings

FIG. 1 is a structural diagram of a steering device according to a preferred embodiment of the present invention.

Figure 2 is the second structural diagram of the steering device according to a preferred embodiment of the present invention.

Figure 3 is a top view of the steering device according to a preferred embodiment of the present invention.

Figure 4 is a cross-sectional view of A-A in Figure 3.

Figure 5 is a steering diagram 1 of a preferred embodiment of the present invention.

Figure 6 is a schematic diagram of the steering in blood vessels according to a preferred embodiment of the present invention.

Reference signs: 1. Steering device; 2. Rotating axis one; 3. Rotating axis two; 4. Distal section; 5. Proximal section; 6. Microcatheter; 7. Interventional catheter; 8. Guide wire; 9. Gear one; 10. Rotation axis; 11. Gear two; 12. Pull wire; 13. Gear three; 14. Gear four; 15. External ring pull wire.

Detailed ways

In order to make the present invention more obvious and understandable, the preferred embodiments are described in detail as follows together with the accompanying drawings:

As shown in Figures 1-6, the present invention provides a steering device 1 for interventional surgery. In the interventional surgery, the end section of the interventional object is provided with a steering device 1 for guiding the interventional object to change its forward direction. The steering device 1 includes a rotation mechanism. 1 and rotating mechanism 2; rotating mechanism 1 is provided with a rotating shaft 2 along the radial direction of the interventional lumen, and rotating mechanism 2 is provided with a rotating shaft 23 along the radial direction of the interventional lumen; rotating shaft 23 is perpendicular to the rotating shaft 12 Connection; The intervention objects on the front and rear sides of the steering device 1 along the intervention direction are respectively arranged as a distal section 4 away from the operator and a proximal section 5 close to the operator; the distal section 4 is connected to the rotation axis 23; the proximal end Section 5 is connected to the rotating shaft 2; the steering device 1 is provided with a driving device 1 for driving the rotating shaft 2, the rotating shaft 2 3 and the distal section 4 to rotate axially around the central axis of the rotating shaft 2; the steering device 1 also A driving device 2 is provided for driving the rotating shaft 2 3 and the distal section 4 to rotate axially around the central axis of the rotating shaft 2 3 .

The interventional objects in the interventional procedure include (but are not limited to) catheters or microcatheters.

The steering device 1 is arranged at the end of a microcatheter 6, which is inserted into the interventional catheter 7, and a guide wire 8 is also inserted into the microcatheter 6; the microcatheters 6 on the front and rear sides of the steering device 1 along the interventional direction are respectively arranged as a distal section 4 away from the operator and a proximal section 5 close to the operator; the distal section 4 is connected to the rotation shaft 2 3; the proximal section 5 is connected to the rotation shaft 1 2. A retractable elastic catheter is arranged between the distal section 4 and the proximal section 5, and the function of the retractable elastic catheter is that when the distal section 4 rotates, the distance between the distal section 4 and the proximal section 5 will change, and the retractable elastic catheter can just meet the need of this change.

In another embodiment, the distal section 4 and the proximal section 5 can also be arranged in an interrupted manner. This discontinuous design does not affect the movement of the guide wire 8 threaded in the microcatheter 6 from the proximal section 5 Enter distal segment 4.

The rotating shaft 2 is provided with a gear 9 for driving the rotating shaft 2 to rotate around the central axis of the rotating shaft 2 . A rotating shaft 10 is passed through the body of the rotating shaft 2, and the rotating shaft 10 is perpendicular to the rotating shaft 23; the rotating shaft 23 is vertically arranged on the body of the rotating shaft 2, and one end of the rotating shaft 3 is connected to the rotating shaft 2. One end of the shaft 10 is connected through gear meshing. The rotating shaft 10 is provided with a gear 11 for driving the rotating shaft 10 to rotate around the central axis of the rotating shaft 10 . Gear one 9 and gear two 11 are provided with pull wires 12 for pulling the gears to rotate.

The present invention also provides a steering system for interventional surgery. The steering system includes the above-mentioned steering device; and the rotating shaft 2 and the rotating shaft 2 3 are provided with angle sensors. The steering system also includes a software module that calculates the rotation angle of the guide wire 8 based on the rotation angle data of the rotation axis 2 and the rotation axis 2 3 and a software module that simulates the rotation angle of the guide wire 8 in the virtual human body in vitro.

Example

As shown in Figure 1-6, the end section of the microcatheter 6 is provided with a steering device 1, the microcatheter 6 can be inserted into the interventional catheter 7, and the microcatheter 6 is further equipped with a guide wire 8;

The steering device 1 includes a rotation axis 2 along the radial direction of the lumen of the interventional catheter 7 and a rotational axis 23 along the radial direction of the lumen of the interventional catheter 7. The rotational axis 12 is perpendicular to the rotational axis 23;

The microcatheters 6 on the front and rear sides of the steering device 1 along the intervention direction are respectively set as a distal section 4 away from the operator and a proximal section 5 close to the operator; the distal section 4 is connected to the rotation axis 2 3 through an arc plate. Fixed connection, when the rotating shaft 23 rotates, the distal section 4 rotates together with the rotating shaft 23.

The proximal section 5 is movably connected to the rotating shaft 2 through an arc plate; when the pull wire is in a relaxed state, the rotating shaft 2 is in a state where it can rotate.

A telescopic elastic catheter is provided between the distal section 4 and the proximal section 5 .

The shaft body of the rotating shaft - 2 is hollow, and a gear - 9 for driving the rotating shaft - 2 to rotate around the central axis of the rotating shaft - 2 is set around the body of the rotating shaft - 2.

A rotating shaft 10 is passed through the hollow shaft body of the rotating shaft 12. One end of the rotating shaft 10 is provided with a bevel gear 4 14, and the other end of the rotating shaft 10 is provided with a gear 2 11;

The central axis of the rotating shaft 10 is perpendicular to the central axis of the rotating shaft two 3; the rotating shaft two 3 is vertically clamped on the shaft body of the rotating shaft one 2, and the end of the rotating shaft two 3 is inserted into the shaft body of the rotating shaft one 2 , the end of the rotating shaft 23 is provided with a bevel gear 313, and the bevel gear 313 is connected to the bevel gear 414 at one end of the rotating shaft 10 through gear meshing.

The rotating shaft 10 is provided with a gear 2 11 for driving the rotating shaft 10 to rotate around the central axis of the rotating shaft 10; when the rotating shaft 10 rotates, the rotating shaft 2 is driven by the gear meshing transmission of the bevel gear 4 14 and the bevel gear 3 13. 3 rotates, thereby driving the distal section 4 of the microcatheter 6 to rotate left and right.

Gear one 9 and gear two 11 are respectively provided with pull wires for pulling gear one 9 and gear two 11 to rotate. Different pulling wires are pulled outside the body to drive gear one 9 and gear two 11 to rotate respectively.

The pull wires that control the rotation of gear one 9 or gear two 11 can be connected in a ring shape outside the body to form an extracorporeal ring pull wire 15, and a mechanical structure can be used to tighten or relax the ring pull wire; the external ring pull wire 15 is in the body The ends are respectively connected to gear one 9 or gear two 11; when turning, you only need to perform a forward or reverse operation on the two annular cables respectively to control the rotation of gear one 9 or gear two 11, that is, to complete the rotation axis one 2 or the rotation axis 2.3 The work of turning.

The present invention also provides a steering system for interventional surgery. The steering system includes the above-mentioned steering device; and the rotating shaft 2 and the rotating shaft 2 3 are provided with angle sensors. The steering system also includes a software program, which can calculate the rotation angle of the distal section 4 of the microcatheter 6 and the guide wire 8 through the obtained rotation angle data of the rotation axis one 2 and the rotation axis two 3; the software program can also calculate The guide wire 8 is simulated to rotate in a virtual human body outside the body, thereby helping the doctor or guiding the surgical robot to complete the interventional surgery.

Use of the present invention:

When the guide wire 8 needs to enter the target branch blood vessel, the pull wire is pulled outside the body to drive the gear 9 to rotate. The rotation of the gear 9 drives the rotation shaft 2 to rotate. Since the rotation shaft 2 3 is vertically stuck on the shaft body of the rotation shaft 2 , therefore, the rotating shaft 2 3 also rotates with the rotation of the rotating shaft 2 3; when the rotating shaft 2 3 rotates, the distal section 4 of the microcatheter 6 fixedly connected to the rotating shaft 2 3 also rotates along with the rotating shaft 2 3 Rotate, thereby causing the distal segment 4 to move up and down relative to the plane formed by the rotation axis 2 and the proximal segment 5;

After the distal section 4 rotates to a certain position, the pull wire is pulled outside the body to drive gear 2 11 to rotate. Gear 2 11 rotates to drive the rotating shaft 10 to rotate around the central axis of the rotating shaft 10, and then the gear meshing transmission between bevel gear 4 14 and bevel gear 3 13 drives the rotating shaft 2 3 to rotate, thereby driving the distal section 4 to rotate left and right relative to the plane formed by the rotating shaft 2 3 and the proximal section 5.

Thus, the distal section 4 can move up and down relative to the horizontal plane of the catheter, and move left and right relative to the vertical plane of the catheter.

In this way, by pulling the different pull wires back and forth, the distal segment 4 is driven first up and down, and then left and right, thereby driving the distal segment 4 to obtain a wide range of steering space similar to a universal joint type. Finally, align the distal segment 4 with the target branch blood vessel, and then push the guide wire 8 so that the guide wire 8 enters the target branch blood vessel;

After the guide wire 8 enters the target blood vessel, loosen all the pulling wires so that the rotation axis 1 2 and the rotation axis 2 3 are in a passive and following state; the distal segment 4 can freely change the direction of travel along with the direction of the guide wire 8, so that The steering device 1 can move forward or backward along with the guide wire 8 .

Further, angle sensors are provided on the rotation axis one 2 and the rotation axis two 3. The steering system also includes a software module that calculates the rotation angle of the distal segment 4 based on the rotation angle data of the rotation axis one 2 and the rotation axis two 3, and simulates the distal segment 4 in vitro. The software module allows the distal segment 4 to rotate at an angle in the virtual human body and match the target branch blood vessel; it is more convenient to fine-tune gear one 9 and gear two 11 to align the distal segment 4 with the target branch blood vessel more quickly, so that The guide wire 8 can enter the target branch blood vessel more quickly.

The present invention enables the interventional guide wire 8 to obtain four degrees of freedom: up and down, left and right, axial push and pull, and axial rotation, thereby increasing the movement modes of the interventional guide wire 8;

Through the present invention, the interventional catheter obtains the function of realizing steering in a wide range, and by designing a mechanical structure with mechanically controllable steering, the steering operation is no longer an operation with a chance of success. It can greatly improve the steering success rate, better cope with abnormal blood vessel directions during surgery due to individual differences in patients, reduce the guidewire steering operation time, and reduce the dependence on the operator's actual experience.

The above are only preferred embodiments of the present invention, and do not limit the present invention in any form or substance. It should be pointed out that those of ordinary skill in the art can also make other modifications without departing from the present invention. Several improvements and additions are made, and these improvements and additions should also be regarded as the protection scope of the present invention. Those skilled in the art who are familiar with the art can make slight changes, modifications and equivalent changes based on the technical content disclosed above without departing from the spirit and scope of the invention. Equivalent embodiments; at the same time, any equivalent changes, modifications and evolutions made to the above embodiments based on the essential technology of the present invention still fall within the scope of the technical solution of the present invention.

Claims (10)

1. A steering device for interventional surgery. The end section of the intervention is provided with a steering device for guiding the intervention to change its forward direction. It is characterized by: The steering device includes a rotating mechanism 1 and a rotating mechanism 2; the rotating mechanism 1 is provided with a rotating shaft 1 along the radial direction of the interventional lumen, and the rotating mechanism 2 is provided with a rotating shaft 2 along the radial direction of the interventional lumen; The second rotation axis is vertically connected to the first rotation axis; The front and rear intervention objects of the steering device along the intervention direction are respectively set as a distal section away from the operator and a proximal section close to the operator; the distal section is connected to the second rotating shaft; the proximal section is connected to the first rotating shaft; The steering device is provided with a driving device 1 for driving the rotating shaft 1, the rotating shaft 2 and the distal section to rotate axially around the central axis of the rotating shaft 1; the steering device is also provided with a driving device 2 for driving the rotating shaft 2 and the distal section to rotate axially around the central axis of the rotating shaft 2. 2. A steering device for interventional surgery according to claim 1, characterized in that the interventional object includes a catheter or a microcatheter. 3. A steering device for interventional surgery according to claim 2, characterized in that the steering device is provided at the end of a microcatheter, and the microcatheter is penetrated in the interventional catheter. The catheter is provided with a guide wire; the microcatheters on the front and rear sides of the steering device along the intervention direction are respectively set as a distal section far away from the operator and a proximal section close to the operator; the distal section is connected to the rotation axis. Connect; the proximal section is connected to the rotation axis. 4. A steering device for interventional surgery according to claim 3, characterized in that a telescopic elastic catheter is provided between the distal section and the proximal section. 5. A steering device for interventional surgery according to claim 3, characterized in that the rotating shaft is provided with a gear for driving the rotating shaft to rotate around the central axis of the rotating shaft. 6. A steering device for interventional surgery according to claim 5, characterized in that a rotation axis is penetrated through the body of the first rotation axis, and the rotation axis is perpendicular to the second rotation axis; the second rotation axis is perpendicular to It is arranged on the shaft body of the first rotating shaft, and one end of the second rotating shaft is connected to one end of the rotating shaft through gear meshing. 7. A steering device for interventional surgery according to claim 6, characterized in that the rotating shaft is provided with a second gear for driving the rotating shaft to rotate around the central axis of the rotating shaft. 8. A steering device for interventional surgery according to claim 7, characterized in that the first gear and the second gear are provided with pull wires for pulling the gears to rotate. 9. A steering system for interventional surgery, characterized in that the steering system includes the steering device according to any one of claims 1 to 8; the first rotation axis and the second rotation axis are provided with There is an angle sensor. 10. A steering system for interventional surgery according to claim 9, characterized in that the steering system includes a software module for calculating the rotation angle of the intervention object through the data of the rotation angles of the first rotation axis and the second rotation axis. A software module that simulates the rotation angle of an interventional object in the virtual human body in vitro.