Remote visual guide sheath tube device

Abstract

The utility model discloses a remote visual guiding sheath tube device and system, and relates to the medical instrument technology, and the device comprises a tail line guiding part which comprises a handle, an electrode ring wire and a saline water pipe, and is used for regularly guiding the electrode ring wire and the saline water pipe in the mapping process; the mechanical transmission part is arranged at one end of the handle, and the other end of the mechanical transmission part is led out of the guide sheath tube; and the visual component is realized based on the guiding sheath tube and comprises visual electrode rings, and a plurality of visual electrode rings are arranged at the head end of the guiding sheath tube at intervals. The device can be matched with a compatible interventional operation robot to complete remote catheter guiding and bent guiding control, and the problem that in a cardiac interventional operation, a guiding sheath tube is directly controlled remotely through the operation robot, so that the influence of X-ray radiography is avoided.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a remote visualization guide sheath device. Background Art

[0002] Cardiac interventional surgery is a new technology for diagnosing and treating cardiovascular diseases. After puncturing the surface blood vessels, a guide sheath is inserted under continuous projection of digital silhouettes to establish a catheter pathway for subsequent treatment catheters to enter the heart. During cardiovascular interventional surgery, the surgeon usually needs to use both hands to simultaneously manipulate the sheath and catheter to complete the intracardiac interventional surgery. With the assistance of DSA angiography and three-dimensional mapping navigation system images, the doctor manually manipulates the sheath and catheter, and through multi-degree-of-freedom manipulation, passes through the peripheral blood vessels and places the treatment head of the interventional device at the specific location of the disease in the heart cavity. Once in place, the doctor simultaneously injects contrast agent through the three-way interface of the sheath to confirm the image position and then complete the corresponding interventional treatment. The entire operation is performed on a beating heart. Therefore, when the doctor manually manipulates the interventional device for treatment, it is very critical to control the stability of the catheter. Improper operation can easily cause serious complications such as cardiac perforation. With the development of the medical industry, some new medical devices provide doctors with more treatment methods. Surgery can be controlled by surgical robots. The mechanized control method provides a guarantee for the stable operation of treatment devices. However, when using surgical robots, directly handing over traditional interventional instruments to robots for control will cause the following problems:

[0003] Manual sheaths cannot be directly linked to the robot's motor drive components. Traditional sheaths need to be specifically improved and adapted, and additional propulsion mechanisms need to be added to complete the adaptation to the surgical robot's drive components, thereby completing operations with corresponding degrees of freedom.

[0004] When the surgical robot remotely controls the sheath for rotational movement, the saline contrast agent pipeline at the sheath handle and the tail wire of the signal line at the handle end are easily entangled at the handle, causing a jam with the robot actuator. In severe cases, the actuator may even be stuck, causing the operation to fail.

[0005] During the operation, the surgeon cannot use the three-dimensional mapping system to perform three-dimensional imaging of the sheath and can only confirm the position of the sheath through X-ray angiography. In some special positions of the heart, when the sheath and catheter need to cooperate to make an S-bend, the surgeon needs to use rich clinical experience to determine the actual position and status of the sheath. The surgeon's operation requirements are very high. The surgeon can only judge the next operation by imagining the relative position of the sheath tip and the catheter in the body in three-dimensional space, so as to control the catheter tip to the correct position of the lesion, thereby greatly increasing the surgeon's brain calculation amount and operation time, and indirectly increasing the risk during the operation.

[0006] Traditional sheaths are prone to causing damage to the inner wall of blood vessels during axial advancement and retreat. The sheath body is hollow. When the sheath tip contacts the inner wall of the heart, the catheter will form a negative pressure space when it retreats inside the sheath. If the catheter retreats quickly, it will damage the inner wall of the heart. Utility Model Content

[0007] An embodiment of the present application provides a remote visualization guide sheath device that can cooperate with a compatible interventional surgical robot to complete remote catheter guidance and bend guidance control, thereby solving the problem of directly controlling the guide sheath remotely through the surgical robot during cardiac interventional surgery, thereby avoiding the influence of X-ray angiography.

[0008] The present invention provides a remote visualization guide sheath device, comprising:

[0009] The tail wire guide component 2 includes a handle, an electrode ring wire 21, and a saline tube 22. The tail wire guide component 2 is used to regularly guide the electrode ring wire 21 and the saline tube 22 during the mapping process. The electrode ring wire 21 is electrically connected to the visualization electrode ring 11 of the visualization component 1 to access the mapping system. The saline tube 22 is connected to the guide sheath to provide saline during the mapping process.

[0010] a mechanical transmission component 3, which is provided on one end of the handle, and the other end of the mechanical transmission component 3 leads to the guide sheath, and the mechanical transmission component 3 is adapted to be adapted to the surgical robot to transmit the required action to the guide sheath under the control of the surgical robot;

[0011] The visualization component 1 is implemented based on the guide sheath and includes at least four visualization electrode rings 11 . The at least four visualization electrode rings 11 are axially spaced apart and arranged at the head end of the guide sheath. The visualization electrode rings 11 lead out the electrode ring wires 21 .

[0012] Optionally, the mechanical transmission component 3 includes an axial transmission component and a rotary transmission component, wherein the axial transmission component and the rotary transmission component are respectively used to connect to the actuator of the surgical robot to perform corresponding actions.

[0013] Optionally, the axial transmission assembly includes two fixing frames adapted to the surgical robot, so that after the actuator of the surgical robot is connected, the fixing frames are inserted into corresponding positions to control the axial movement of the guide sheath;

[0014] The rotary transmission assembly includes a rotary meshing gear, which is used to mesh with the actuator rotary driving gear of the surgical robot to control the rotation of the guide sheath.

[0015] Optionally, the tail wire guide component 2 is provided with a hemostatic valve assembly 25 at the other end of the handle.

[0016] Optionally, a wiring groove 13 is provided on the guide sheath, and the wiring groove 13 is used to lead out the wire of the visualization electrode ring 11. A negative pressure prevention microhole 12 is provided in the wiring groove 13 at the head end of the guide sheath.

[0017] Optionally, the other end of the handle of the tail wire guide component 2 is further provided with a guide slot 23 and an anti-winding baffle 24. In the initial state, the electrode ring wire 21 and the saline tube 22 can be wound around the tail wire guide component 2. The guide slot 23 is used to guide the winding of the electrode ring wire 21 and the saline tube 22 respectively, and the anti-winding baffle 24 is used to provide winding intervals for the electrode ring wire 21 and the saline tube 22 respectively.

[0018] Optionally, the guide slot 23 is centered on the handle axis and is arranged on the side of the handle at 90° to the handle tail line. The axial position of the guide slot is respectively forward of the handle corresponding tail line and saline tube position.

[0019] An embodiment of the present application also proposes a remote visualization guide sheath system, including a surgical robot and a remote visualization guide sheath device as described above, wherein the surgical robot is connected to the remote visualization guide sheath device through a corresponding actuator to control the remote visualization guide sheath device to perform corresponding actions according to control instructions.

[0020] The remote visualization guide sheath device of the embodiment of the present application can cooperate with a compatible interventional surgical robot to complete remote catheter guidance and bending guidance control, thereby solving the problem of remotely controlling the guide sheath through the surgical robot during cardiac interventional surgery, thereby avoiding the influence of X-ray angiography.

[0021] The above description is only an overview of the technical solution of the present application. In order to more clearly understand the technical means of the present application, it can be implemented in accordance with the contents of the specification. In order to make the above and other purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are listed below. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Various other advantages and benefits will become apparent to those skilled in the art upon reading the detailed description of the preferred embodiment below. The accompanying drawings are for illustration purposes only and are not to be considered as limiting the present application. The same reference symbols are used throughout the drawings to represent the same components. In the drawings:

[0023] Figure 1 This is a schematic diagram of the overall structure of the remote visualization guide sheath device according to an embodiment of the present application;

[0024] Figure 2This is a schematic diagram of the local structure of the guide sheath of the remote visualization guide sheath device according to an embodiment of the present application;

[0025] Figure 3 This is a schematic diagram of the structure of the tail wire guide component of the remote visualization guide sheath device according to an embodiment of the present application;

[0026] Figure 4 This is a schematic diagram of the mechanical transmission components and tail wire guide components of the remote visualization guide sheath device according to an embodiment of the present application;

[0027] Figure 5 This is a schematic diagram of the structure of the mechanical transmission components of the remote visualization guide sheath device according to an embodiment of the present application. DETAILED DESCRIPTION

[0028] Exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although exemplary embodiments of the present disclosure are shown in the accompanying drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of the present disclosure and to fully convey the scope of the present disclosure to those skilled in the art.

[0029] Interventional therapy is a modern medicine that has been rapidly promoted in recent decades. It usually requires the use of catheter devices of various structures, shapes, and sizes to establish a channel between the diseased area in the patient's body and the external operating end, so as to introduce various diagnostic and treatment instruments, drugs, and implantable devices to the patient's diseased area. During cardiovascular interventional surgery, the surgeon usually needs to use both hands to simultaneously control the catheter and sheath to complete the intracardiac interventional surgery. With the assistance of DSA angiography and three-dimensional mapping navigation system, the doctor manually operates the sheath and catheter, and through multi-degree-of-freedom manipulation, places the interventional device in the designated heart cavity through the peripheral blood vessels, and uses the combination of the fixed bend of the sheath tip and the adjustable bend of the catheter tip to control the movement of the catheter tip to the specific position in the heart cavity that requires ablation treatment, and then perform ablation treatment on it.

[0030] The coordination process between the catheter and the sheath is as follows: first, the sheath needs to be punctured through the femoral vein to enter the target heart cavity. The catheter uses the catheter channel established by the sheath to pass through the sheath and enter the target heart cavity. Since the sheath head is provided with a fixed bend, the fixed bend of the sheath head is pointed to the target ablation site by rotating the sheath. The sheath is pushed axially to make the sheath head as close to the target ablation site as possible. Then the ablation catheter is pushed axially to make the ablation catheter pass through the fixed bend of the sheath and extend out of the sheath head, ensuring that the adjustable bend of the ablation catheter is completely extended out of the sheath head. On the basis of the fixed bend of the sheath, the catheter is manipulated to bend and rotate and to push axially until the large head electrode at the catheter head reaches the target ablation position for ablation treatment. During the manipulation, the doctor also injects contrast agent through the three-way interface of the sheath to confirm the position of the image.

[0031] During this procedure, the surgeon is required to wear a heavy lead vest while simultaneously manipulating the catheter and sheath. This is extremely labor-intensive and impacts the surgeon's efficiency. In recent years, with the rapid development of the medical surgical robotics industry, surgeons can remotely control the axial movement and circumferential rotation of interventional instruments using a robotic arm. However, the sheath is still not visible in three-dimensional images, and its position and status within the body can only be determined through the continuous injection of contrast agent and development under X-rays. The surgeon has no way of intuitively understanding the relative position and corresponding angle between the sheath and catheter, and can only rely on surgical experience to conceive the current state of the sheath and catheter to determine the next surgical procedure.

[0032] During the atrial fibrillation ablation procedure, the catheter and sheath need to cooperate with each other to control the large-head electrode at the catheter tip to reach the target ablation point for treatment. The relative position and corresponding status of the catheter and sheath during the operation are very important. The three-dimensional mapping system only displays the three-dimensional image of the catheter. The operator can only rely on feel and experience to judge whether the adjustable bend part of the catheter tip is completely extended from the sheath tip and control the catheter to bend at a small angle. If the bending push rod is very heavy, it means that the adjustable bend part of the catheter tip is still in the sheath lumen. If the bending push rod is relatively heavy, it means that the adjustable bend part of the catheter tip has mostly extended out of the sheath lumen. If the bending push rod is loose, it means that the adjustable bend part of the catheter tip has completely extended out of the sheath lumen. During the operation, the operator can only rely on the weight of the bending feel to judge the relative position of the adjustable bend part of the catheter and the sheath. The above method requires the operator to have rich surgical experience to make accurate judgments, which is very demanding of the operator.

[0033] Based on this, the embodiment of the present application provides a remote visualization guide sheath device, which mainly includes a guide sheath and a sheath handle, wherein the sheath handle includes a mechanical transmission component and a tail wire guide component, and a sheath visualization component is provided on the guide sheath, which is used to visualize the sheath tip in a three-dimensional mapping system during surgery, intuitively demonstrate the relative position and status of the sheath tip and the catheter tip, and assist the surgeon in improving surgical efficiency and safety. Figure 1 As shown, specifically including:

[0034] The tail wire guide component 2 includes a handle, an electrode ring wire 21, and a saline tube 22. The tail wire guide component 2 is used to regularly guide the electrode ring wire 21 and the saline tube 22 during the mapping process. The electrode ring wire 21 is electrically connected to the visualization electrode ring 11 of the visualization component 1 to access the mapping system. The saline tube 22 is connected to the guide sheath to provide saline during the mapping process.

[0035] A mechanical transmission component 3 is provided on one end of the handle, and the other end of the mechanical transmission component 3 leads to the guide sheath. The mechanical transmission component 3 is used to adapt to the surgical robot to transmit the required action to the guide sheath under the control of the surgical robot. The remote visualization guide sheath device of the embodiment of the present application is provided with a mechanical transmission component 3 and a tail wire guide component 2 on the sheath handle. The mechanical transmission component is used to adapt to the mechanical transmission of the surgical robot for axial advance and retreat and circumferential rotation control. The tail wire guide component is used to guide the wire at the end of the sheath handle and the saline tube to be regularly wound around the handle, thereby preventing the surgical robot from malfunctioning due to the entanglement of the wire and the saline tube during surgery, thereby preventing surgical accidents.

[0036] The visualization component 1 is implemented based on the guide sheath and includes at least four visualization electrode rings 11. At least four visualization electrode rings 11 are axially spaced apart and arranged at the head end of the guide sheath. The visualization electrode rings 11 lead out the electrode ring wires 21. In some embodiments, the visualization electrode rings are at least four platinum-iridium metal electrodes. In other embodiments, during the sheath forming process, the electrode wires pass through the wiring groove, and a layer of clear water coating is applied to the outside of the tube to form a smooth tube body, thereby preventing the sheath from causing damage to the peripheral blood vessels during axial movement.

[0037] The remote visualization guide sheath device of the embodiment of the present application can cooperate with a compatible interventional surgical robot to complete remote catheter guidance and bending guidance control, thereby solving the problem of remotely controlling the guide sheath through the surgical robot during cardiac interventional surgery, thereby avoiding the influence of X-ray angiography.

[0038] Independently or additionally, the guide sheath is provided with a wiring groove 13, the wiring groove 13 is used to lead out the wire of the visualization electrode ring 11, and the wiring groove 13 at the head end of the guide sheath is provided with a negative pressure prevention microhole 12. Figure 2 As shown, in a specific application, the guide sheath body is an irregular flat structure, and a wiring groove is provided on the body to facilitate the arrangement of the electrode ring wires and reduce the overall outer diameter of the lumen and the appearance of the protrusion. In the sheath molding process, the electrode wires pass through the wiring groove. The electrode ring signal line passes through the wiring groove 13 of the sheath body, and is connected to the electrophysiological three-dimensional mapping system at the tail. Under DSA angiography and three-dimensional mapping systems, the position and bending direction of the sheath head can be visualized. The surgeon can see the relative position and corresponding bending of the sheath head and the catheter head at the same time in the three-dimensional mapping system, and more intuitively obtain the current status of the catheter and sheath and the relative position relationship with the target ablation point, which is convenient for the surgeon to clarify the next surgical instruction, improve surgical efficiency, reduce surgical difficulty, and significantly shorten the surgeon training cycle.

[0039] The sheath tube head end is provided with a fixed bend and a tip forming treatment at the same time, which makes it easier for the sheath tube to enter a specific position in the heart cavity. The sheath tube head end is also provided with a negative pressure prevention microhole 12. When the sheath tube contacts the inner wall of the heart, the catheter is withdrawn in the sheath tube and a negative pressure space is easily formed at the sheath tube head end. The negative pressure can be released through the negative pressure prevention microhole to avoid damage to the inner wall of the heart when the catheter is withdrawn in the sheath tube.

[0040] The saline pipeline and wire guiding structure of the present application can regularly wind the saline pipeline and electrode ring wire around the handle during rotational control, without causing jamming to the surgical robot, thereby solving the problem of safe surgical operation caused by entanglement of wires and saline pipeline during surgery and solving the problem of surgical accidents caused by this.

[0041] Independently or additionally, the tail wire guide component 2 has a hemostatic valve assembly 25 at the other end of the handle. Figure 3 As shown, the hemostatic valve assembly 25 is fixed to the rear end of the handle. When a catheter interventional instrument needs to be exchanged during surgery, the hemostatic valve assembly 25 can prevent blood from flowing out of the rear end of the sheath. The sheath can be fixed as a whole to the surgical robot's actuator, eliminating the need to remove the sheath from the robot's actuator to replace the catheter. This avoids the need to manually operate the sheath and switch between instrument assembly and robotic operation, reducing surgical time, improving surgical efficiency, and facilitating the promotion and application of robotic surgical procedures.

[0042] Independently or additionally, the tail wire guide component 2 is further provided with a guide slot 23 and an anti-winding baffle 24 at the other end of the handle. In the initial state, the electrode ring wire 21 and the saline tube 22 can be wound around the tail wire guide component 2. The guide slot 23 is used to guide the winding of the electrode ring wire 21 and the saline tube 22 respectively, and the anti-winding baffle 24 is used to provide winding intervals for the electrode ring wire 21 and the saline tube 22 respectively. Figure 4 As shown, the side of the tail end of the handle is externally connected to an electrode ring wire and a saline tube. The electrode ring wire is used to connect the electrode ring at the head end to the three-dimensional mapping system. During the process of the surgical robot controlling the rotation of the guide sheath, the tail wire guide component guides the electrode ring wire 21 and the saline tube 22 in a regular manner so that they are regularly wound on the handle. The electrode ring wire 21 and the saline tube 22 are also respectively provided with anti-winding baffles near the tail end of the handle to limit the winding of the electrode ring wire and the saline tube in a fixed direction and prevent reverse winding. At the same time, it also plays the role of isolating the electrode ring wire. When the electrode ring wire or the saline tube on the sheath handle is wound multiple times, the electrode ring wire and the saline tube will not be entangled with each other, causing a machine malfunction error.

[0043] Independently or additionally, the guide slot 23 is arranged on the side of the handle at 90 degrees to the tail line of the handle with the handle axis as the center of the circle. The axial position of the guide slot is respectively forward of the tail line and the saline tube position corresponding to the handle, for example, half the distance of the tube body in front, so as to guide the electrode ring wire 21 and the saline tube 22 to be regularly wound around the handle in a fixed direction.

[0044] Independently or additionally, the mechanical transmission component 3 includes an axial transmission component 31 and a rotary transmission component 32, wherein the axial transmission component 31 and the rotary transmission component 32 are respectively used to connect to the actuator of the surgical robot to perform corresponding actions.

[0045] In some embodiments, as Figure 5 As shown, the axial transmission assembly 31 includes two fixing frames adapted to the surgical robot, which are inserted into corresponding positions after the actuator of the surgical robot is connected to control the axial movement of the guide sheath;

[0046] The rotary transmission assembly 32 includes a rotary meshing gear, which is used to mesh with the actuator rotary driving gear of the surgical robot to control the rotation of the guide sheath.

[0047] The remote visualization guidance sheath device of the present application embodiment has four electrode rings spaced apart at the sheath tip, allowing the sheath tip and catheter to be visualized together under a three-dimensional mapping system. This allows the surgeon to more intuitively guide the next step of the procedure when the surgeon controls the sheath through a surgical robot. A guiding structure is provided at the handle end, which is arranged at a certain angle to the electrode ring wire outlet at the sheath handle end to guide the electrode ring wire to be regularly wound in a specified direction.

[0048] The sheath handle of the present application is a special handle for interventional surgical robots. A mechanical transmission component is provided at the handle end. Without adding an additional adapter, the sheath can be controlled by the surgical robot for circumferential rotation and axial motion control. The axial movement accuracy can reach sub-millimeter accuracy far exceeding manual movement. At the same time, high-precision rotation control can be achieved. When performing catheter operations at local positions in the heart, the sheath device of the present invention can achieve high-precision quantitative operations.

[0049] An embodiment of the present application also proposes a remote visualization guide sheath system, including a surgical robot and a remote visualization guide sheath device as described above, wherein the surgical robot is connected to the remote visualization guide sheath device through a corresponding actuator to control the remote visualization guide sheath device to perform corresponding actions according to control instructions.

[0050] It should be noted that, in the various embodiments of the present application, the terms "comprises," "includes," or any other variations thereof are intended to encompass non-exclusive inclusion, such that a process, method, article, or apparatus comprising a series of elements includes not only those elements, but also other elements not explicitly listed, or elements inherent to such process, method, article, or apparatus. In the absence of further limitations, an element defined by the phrase "comprising a ..." does not exclude the presence of other identical elements in the process, method, article, or apparatus comprising the element.

[0051] The serial numbers of the above embodiments of the present application are for description only and do not represent the advantages or disadvantages of the embodiments.

[0052] The embodiments of the present application are described above in conjunction with the accompanying drawings, but the present application is not limited to the above-mentioned specific implementation methods. The above-mentioned specific implementation methods are merely illustrative and not restrictive. Under the guidance of this application, ordinary technicians in this field can also make many forms without departing from the purpose of this application and the scope of protection of the claims, all of which are protected by this application.

Claims

1. A remote visualization guide sheath device, characterized in that: include: A tail wire guide component (2) comprises a handle, an electrode ring wire (21) and a saline tube (22); the tail wire guide component (2) is used to regularly guide the electrode ring wire (21) and the saline tube (22) during the mapping process; the electrode ring wire (21) is electrically connected to the visualization electrode ring (11) of the visualization component (1) to access the mapping system; the saline tube (22) is connected to the guide sheath to provide saline during the mapping process; A mechanical transmission component (3) is provided on one end of the handle, the other end of the mechanical transmission component (3) leading out of the guide sheath, and the mechanical transmission component (3) is adapted to be adapted to a surgical robot so as to transmit a required action to the guide sheath under the control of the surgical robot; The visualization component (1) is realized based on the guide sheath and comprises at least four visualization electrode rings (11). The at least four visualization electrode rings (11) are axially spaced and arranged at the head end of the guide sheath. The visualization electrode rings (11) lead out the electrode ring wires (21).

2. The remote visualization guide sheath device according to claim 1, characterized in that: The mechanical transmission component (3) comprises an axial transmission component and a rotary transmission component, wherein the axial transmission component and the rotary transmission component are respectively used to connect to the actuator of the surgical robot to perform corresponding actions.

3. The remote visualization guide sheath device according to claim 2, characterized in that: The axial transmission assembly includes two fixing frames adapted to the surgical robot, which are inserted into corresponding positions after the actuator of the surgical robot is connected to control the axial movement of the guide sheath; The rotary transmission assembly includes a rotary meshing gear, which is used to mesh with the actuator rotary driving gear of the surgical robot to control the rotation of the guide sheath.

4. The remote visualization guide sheath device according to claim 1, wherein: The tail wire guide component (2) has a hemostatic valve assembly (25) provided at the other end of the handle.

5. The remote visualization guide sheath device according to claim 1, characterized in that: The guide sheath is provided with a wiring groove (13), and the wiring groove (13) is used to lead out the wire of the visualization electrode ring (11). The wiring groove (13) at the head end of the guide sheath is provided with a negative pressure prevention microhole (12).

6. The remote visualization guide sheath device according to claim 1, characterized in that: The tail wire guide component (2) is further provided with a guide slot (23) and an anti-winding baffle (24) at the other end of the handle. In an initial state, the electrode ring wire (21) and the saline tube (22) can be wound around the tail wire guide component (2). The guide slot (23) is used to guide the winding of the electrode ring wire (21) and the saline tube (22), respectively. The anti-winding baffle (24) is used to provide winding intervals for the electrode ring wire (21) and the saline tube (22).

7. The remote visualization guide sheath device according to claim 6, characterized in that: The guide slot (23) is arranged on the side of the handle at 90 degrees to the handle tail line with the handle axis as the center of the circle. The axial position of the guide slot is respectively forward of the handle tail line and the saline tube position.

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