Remote intracardiac bending-adjustable sheathing canal device
By designing a remote intracardiac adjustable bending sheath device, the problem of linking manual sheaths with robots was solved, enabling visualization and precise control of the sheath, improving surgical efficiency and safety, and reducing the risk of vascular injury.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-08-09
- Publication Date
- 2026-04-07
AI Technical Summary
In existing technologies, manual sheaths cannot be directly linked with surgical robots, the saline contrast agent tubing and signal lines at the sheath handle are easily tangled, the sheath is not visible under a three-dimensional mapping system, and traditional fixed curved sheaths cannot adjust the bending angle, which can easily cause damage to the inner wall of blood vessels, resulting in low surgical efficiency and high risk.
A remote intracardiac adjustable bending sheath device was designed, including a tail wire guide component, a mechanical transmission component, and a visualization component. The device achieves axial advance and retreat, circumferential rotation, and bidirectional bending control of the sheath through a gear structure and traction wire. Combined with a visualization electrode ring, the sheath position is visualized under a three-dimensional mapping system, avoiding entanglement and damage.
It improves surgical efficiency and safety, reduces the risk of entanglement and jamming, enables visualization of the sheath under a three-dimensional mapping system, reduces the risk of vascular injury, and improves operational precision and adaptability to surgical robots.
Smart Images
Figure CN224085409U_ABST
Abstract
Description
Technical Field
[0001] This application relates to the field of medical device technology, and in particular to a remote intracardiac adjustable bendable sheath device. Background Technology
[0002] Cardiac interventional surgery is a novel technique for diagnosing and treating cardiovascular diseases. It involves inserting a guide sheath through a punctured blood vessel under continuous digital imaging, establishing a catheter pathway for subsequent treatment catheters to enter the heart. In cardiovascular interventional surgery, the surgeon typically needs to manipulate the sheath and catheter simultaneously with both hands to complete the intracardiac intervention. With the assistance of DSA angiography and a 3D mapping and navigation system, the surgeon manipulates the sheath and catheter manually, using multi-degree-of-freedom control to guide the interventional device through peripheral blood vessels to place the treatment tip of the interventional device at the specific location of the disease within the heart chamber. Once in place, the surgeon simultaneously injects contrast agent through the sheath's three-way connector to confirm the image location, and then completes the corresponding interventional treatment.
[0003] The process of catheter and sheath coordination is as follows: First, the sheath needs to be punctured through the femoral vein to enter the target cardiac chamber. The catheter, using the catheter channel established by the sheath, passes through the sheath and enters the target cardiac chamber. Since the tip of the sheath has a fixed bend, by rotating the sheath, the fixed bend at the tip of the sheath is directed towards the target ablation site. The sheath is pushed axially to bring the tip of the sheath as close as possible to the target ablation site. Then, the ablation catheter is pushed axially to pass through the fixed bend of the sheath and extend out of the tip of the sheath, ensuring that the adjustable bend of the ablation catheter is fully extended out of the tip of the sheath. Based on the fixed bend of the sheath, the catheter is manipulated to bend and rotate and pushed axially until the large electrode at the tip of the catheter reaches the target ablation position for ablation. During the operation, the doctor simultaneously injects contrast agent through the three-way connector on the sheath to confirm the position of the image.
[0004] The entire procedure is performed on a beating heart, so controlling the stability of the catheter is crucial during manual manipulation of interventional devices. Improper operation can easily lead to serious complications such as cardiac perforation. With the development of the medical industry, new medical devices offer doctors more treatment options. Surgery can be controlled by surgical robots, and this mechanized control ensures stable operation of the devices. However, directly entrusting the control of traditional interventional devices to a surgical robot can cause the following problems:
[0005] Manually operated sheaths cannot directly link with the robot's motor drive components. Specific modifications and adaptations are needed to the traditional sheath, adding an additional propulsion mechanism to achieve compatibility with the surgical robot's drive components and thus enable operation with the corresponding degrees of freedom.
[0006] When the surgical robot remotely controls the sheath to rotate, the saline contrast agent tubing at the sheath handle and the signal wire tail at the handle end are prone to getting tangled, which can cause jamming with the robot actuator. In severe cases, it can even jam the actuator, leading to surgical failure.
[0007] During surgery, the surgeon cannot perform three-dimensional imaging of the sheath using a three-dimensional mapping system. The sheath position can only be confirmed by X-ray angiography. In some special cardiac locations where the sheath and catheter need to be used in conjunction to make an S-bend, the surgeon needs to rely on extensive clinical experience to determine the actual position and condition of the sheath. This places very high demands on the surgeon's skills. The surgeon can only judge the next step by imagining the relative position of the sheath tip and the catheter in the body in three-dimensional space in order to control the catheter tip to be correctly positioned at the lesion. This greatly increases the surgeon's operation time, reduces surgical efficiency, and increases the risks during the operation.
[0008] Traditional sheaths are prone to causing damage to the inner wall of blood vessels during axial advance and retreat. The sheath body is hollow and when the tip of the sheath contacts the inner wall of the heart, the catheter will create a negative pressure space when it is withdrawn from the sheath. If the catheter is withdrawn quickly, it will cause damage to the inner wall of the heart.
[0009] Traditional fixed curved sheaths cannot achieve the desired bending angle at the sheath tip under the control of a surgical robot. The direction of the sheath bend can only be controlled by rotating the sheath, and the bending angle at the sheath tip cannot be adjusted. Utility Model Content
[0010] This application provides a remote intracardiac adjustable bending sheath device for adapting to the mechanical transmission of a surgical robot for axial advance, circumferential rotation, and bidirectional bending control, thereby assisting the surgeon in improving surgical efficiency and safety.
[0011] This application provides a remote intracardiac adjustable bendable sheath device for remote catheter guidance and bend control using a compatible interventional surgical robot. The aim is to address how, during cardiac interventional surgery, the surgeon can remotely control a bidirectional adjustable bendable guiding sheath directly via a surgical robot. The device includes:
[0012] The tail wire guide component 2 includes a handle, an electrode ring lead wire 21, and a saline tube 22. The tail wire guide component 2 is used to guide the electrode ring lead wire 21 and the saline tube 22 in a regular manner during the calibration process. The electrode ring lead wire 21 is electrically connected to the visualization electrode ring 31 of the visualization component 3 to connect to the calibration system. The saline tube 22 is connected to the guide sheath to provide saline during the calibration process.
[0013] A mechanical transmission component 1 is disposed on one end of the handle, and the other end of the mechanical transmission component 1 leads out of the guide sheath. The mechanical transmission component 1 is used to control the guide sheath to perform the required movement and / or bending action based on a gear structure.
[0014] The visualization component 3, based on the guide sheath, includes at least four visualization electrode rings 31, which are axially spaced at the head end of the guide sheath. The visualization electrode rings 31 lead out the electrode ring wires 21.
[0015] Optionally, the mechanical transmission component 1 specifically includes:
[0016] The handle housing 102 is a cover structure;
[0017] A double rack bending structure 101 is disposed within the handle housing 102, including a first rack 104, a second rack 105, and a rotating gear 106. The rotating gear 106 is rotatably sleeved within the handle housing 102. The first rack 104 and the second rack 105 are disposed opposite each other in the rack groove 103 and both mesh with the rotating gear 106, so that the rotation of the rotating gear 106 drives the traction wire of the guide sheath to complete the bending action.
[0018] Optionally, two traction wires are provided inside the guide sheath;
[0019] The first rack 104 and the second rack 105 are respectively provided with traction wire fixing holes 107. One end of the two traction wires is connected to the fixing rings on both sides of the guide sheath head end, and the other end is respectively connected to the traction wire fixing holes 107, so that the corresponding traction wires are pulled out under the movement of the first rack and the second rack, so that the guide sheath head end bends and completes the bending action.
[0020] Optionally, the guide sheath is provided with a braided mesh inside the tube, and the tube body of the guide sheath is made of different soft and hard materials to form a hardness difference between the bending section where the electrode ring 31 is provided and the rear end of the tube body.
[0021] Optionally, a fixing block 108 is provided at one end of the first rack 104 facing the head end of the guide sheath. The fixing block 108 has protrusions 109 on both sides. The cover of the handle housing 102 has a groove corresponding to the position of the protrusions 109, and forms an elongated slot 113 after the cover is closed, so that the protrusions 109 can move along the elongated slot. The front end of the handle housing 102 is also used to limit the fixing block 108.
[0022] Optionally, a gear sleeve 110 is fitted at the front end of the handle housing 102, and a bending gear 111 or a circumferential gear 112 is provided on the gear sleeve 110. The circumferential gear 112 or the bending gear 111 is fitted on the outside of the handle housing 102, and the required action is performed by driving the corresponding gear.
[0023] Optionally, the other end of the handle of the tail wire guide component 2 is also 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 on 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.
[0024] Optionally, a hemostatic valve assembly 20 is provided at the other end of the handle of the tail wire guide component 2.
[0025] Optionally, the guide sheath is provided with a wiring groove 33, which is used to lead out the wires of the visualization electrode ring 31, and the guide sheath head end of the wiring groove 33 is provided with a negative pressure prevention micropore 32.
[0026] The device in this application embodiment can be adapted to the mechanical transmission of surgical robots for axial forward and backward movement, circumferential rotation and bidirectional bending control, assisting surgeons in improving surgical efficiency and safety.
[0027] The above description is only an overview of the technical solution of this application. In order to better understand the technical means of this application and to implement it in accordance with the contents of the specification, and to make the above and other objects, features and advantages of this application more obvious and understandable, the following are specific embodiments of this application. Attached Figure Description
[0028] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the scope of this application. Furthermore, the same reference numerals denote the same parts throughout the drawings. In the drawings:
[0029] Figure 1 This is a schematic diagram of the overall structure of the remote intracardiac adjustable bendable sheath device according to an embodiment of this application.
[0030] Figure 2 This is an exploded view of the mechanical transmission components of the remote intracardiac adjustable bendable sheath device according to an embodiment of this application.
[0031] Figure 3 This is a schematic cross-sectional view of the mechanical transmission components of the remote intracardiac adjustable bendable sheath device according to an embodiment of this application;
[0032] Figure 4 This is a schematic diagram of the gear set structure of the mechanical transmission component of the remote intracardiac adjustable bendable sheath device according to an embodiment of this application.
[0033] Figure 5 This is a schematic diagram of the gear sleeve mounting structure of the remote intracardiac adjustable bendable sheath device according to an embodiment of this application;
[0034] Figure 6 This is a schematic diagram of the tail wire guide component of the remote intracardiac adjustable bendable sheath device according to an embodiment of this application.
[0035] Figure 7 This is a schematic diagram of the tail wire guide component of the remote intracardiac adjustable bendable sheath device according to an embodiment of this application.
[0036] Figure 8 This is a visual structural diagram of the components of the remote intracardiac adjustable bendable sheath device according to an embodiment of this application. Detailed Implementation
[0037] Exemplary embodiments of the present disclosure will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.
[0038] Interventional therapy is a modern medical procedure that has been rapidly adopted in recent decades. It typically requires the use of various catheter devices of different structures, shapes, and sizes to establish a channel between the lesion site in the patient's body and the external operating end, so as to introduce various diagnostic and therapeutic instruments, drugs, and implantable devices to the lesion site. In cardiovascular interventional surgery, the surgeon usually needs to use both hands to simultaneously manipulate the catheter and sheath to complete the intracardiac interventional procedure. With the assistance of DSA angiography and three-dimensional mapping and navigation systems, the doctor manipulates the sheath and catheter manually. Through multi-degree-of-freedom manipulation, the interventional device is placed in the designated cardiac chamber through peripheral blood vessels. By using a combination of a fixed bend at the sheath tip and an adjustable bend at the catheter tip, the catheter tip is controlled to move to the specific location in the cardiac chamber that requires ablation treatment, and ablation treatment is performed.
[0039] The above process requires the surgeon to wear heavy lead aprons while simultaneously manipulating the catheter and sheath, resulting in extremely high workload and impacting surgical efficiency. In recent years, with the rapid development of the medical surgical robot industry, surgeons can remotely control the axial movement and circumferential rotation of interventional instruments via robotic arms. Existing catheter ablation surgical robots can remotely control and fix curved sheaths, but this fixation is not visible under 3D imaging. The position and state of the sheath within the body can only be obtained through contrast agent injection and X-ray imaging. Because 3D mapping systems cannot visualize this, surgeons cannot intuitively understand the relative position and angle between the sheath and catheter, and must rely on surgical experience to visualize the current state of the sheath and catheter to determine the next surgical step. This method requires surgeons to have extensive surgical experience, making accurate judgments during manual surgery; long-term experience is crucial, placing extremely high demands on the surgeon.
[0040] Based on this, this application provides a remote intracardiac adjustable bending sheath device for remote catheter guidance and bending control using a compatible interventional surgical robot. The aim is to address how, during cardiac interventional surgery, the surgeon can remotely control a bidirectional adjustable bending guiding sheath via a surgical robot, thereby avoiding the influence of X-ray angiography. The adjustable bending sheath device of this application includes a guiding sheath and a sheath handle. A sheath visualization component is provided on the sheath body for visualization of the sheath tip in a three-dimensional mapping system during surgery, visually demonstrating the relative position and state of the sheath tip and the catheter tip, assisting the surgeon in improving surgical efficiency and safety. The sheath handle is equipped with a mechanical transmission component and a tail wire guiding component. The mechanical transmission component is used to adapt to the mechanical transmission of the surgical robot for axial advance / retreat, circumferential rotation, and bidirectional bending control. Specifically, the adjustable bending sheath device of this application, such as... Figure 1 As shown, it includes:
[0041] The tail wire guide component 2 includes a handle, an electrode ring lead wire 21, and a saline tube 22. The tail wire guide component 2 is used to guide the electrode ring lead wire 21 and the saline tube 22 in a regular manner during the calibration process. The electrode ring lead wire 21 is electrically connected to the visualization electrode ring 31 of the visualization component 3 to connect to the calibration system. The saline tube 22 is connected to the guide sheath to provide saline during the calibration process.
[0042] A mechanical transmission component 1 is disposed at one end of the handle, and the other end of the mechanical transmission component 1 extends out of the guide sheath. The mechanical transmission component 1 is used to control the guide sheath to perform the required movement and / or bending actions based on a gear structure. In some examples, the mechanical transmission component is used to control the guide sheath to complete remotely controlled axial movement, circumferential rotation, and bidirectional bending operations. For example, two gears can be provided. The first meshing gear is used to complete forward and reverse bending operations, and the simultaneous transmission of the two gears can complete the overall rotation of the sheath. The two gears also act as axial movement fixing frames, combined to complete axial forward and backward transmission.
[0043] The visualization component 3, implemented based on the guide sheath, includes at least four visualization electrode rings 31, which are axially spaced at the head end of the guide sheath. Electrode ring wires 21 extend from the visualization electrode rings 31. In some embodiments, the visualization electrode rings 31 are axially spaced at the head end of the guide sheath body; in some examples, the visualization electrode rings 31 are four platinum-iridium metal electrodes.
[0044] The device in this application embodiment can be adapted to the mechanical transmission of surgical robots for axial forward and backward movement, circumferential rotation and bidirectional bending control, assisting surgeons in improving surgical efficiency and safety.
[0045] Independently or additionally, the mechanical transmission component 1 specifically includes:
[0046] Handle housing 102 is a cover structure, such as Figure 2 As shown, the handle housing can be a top and bottom cover structure.
[0047] A double rack bending structure 101 is disposed within the handle housing 102, including a first rack 104, a second rack 105, and a rotating gear 106. The rotating gear 106 is rotatably sleeved within the handle housing 102. The first rack 104 and the second rack 105 are disposed opposite each other in the rack groove 103 and both mesh with the rotating gear 106, so that the rotation of the rotating gear 106 drives the traction wire of the guide sheath to complete the bending action.
[0048] like Figure 3 As shown, the mechanical transmission component 1 includes a double rack bending structure 101 disposed in the handle for completing the bidirectional bending function of the sheath tube. It includes a first rack 104, a second rack 105 and a rotating gear 106. The upper and lower covers of the handle are respectively provided with upper and lower rack grooves 103 for axial sliding of the first rack 104 and the second rack 105. The rotating gear 106 is rotatably sleeved on the fixed post of the lower cover.
[0049] The first rack 104 and the second rack 105 are arranged with their faces facing each other and parallel to each other. The corresponding rack faces are respectively meshed with the rotating gear 106 and connected by gear transmission. The axial movement of the first rack 104 can drive the rotation of the rotating gear 106, and the rotating gear 106 drives the second rack 105 to make an axial displacement in the opposite direction.
[0050] Independently or additionally, two traction wires are provided inside the guide sheath;
[0051] The first rack 104 and the second rack 105 are respectively provided with traction wire fixing holes 107. One end of the two traction wires is connected to the fixing rings on both sides of the guide sheath head end, and the other end is respectively connected to the traction wire fixing holes 107, so that the corresponding traction wires are pulled out under the movement of the first rack and the second rack, so that the guide sheath head end bends and completes the bending action.
[0052] Figure 4 This is a comparison diagram of the two racks before and after relative motion. Figure 3 The relative positions of the first rack 104, the second rack 105, and the rotating gear 106 in their original state are shown. Figure 4 This is a schematic diagram showing the relative position of the first rack 104 after it is pushed forward. Specifically, the first rack 104 and the second rack 105 are respectively provided with traction (steel) wire fixing holes 107. Two traction (steel) wires are provided inside the guide sheath tube. One end of the traction (steel) wire is connected to the traction (steel) wire fixing holes 107 on the first rack and the second rack respectively, and the other end is connected to the fixing rings on the left and right sides of the front end of the guide sheath tube respectively. Through the reverse movement of the first rack 104 and the second rack 105, the corresponding traction (steel) wire is pulled out, so that the front end of the tube body is bent by force, realizing bidirectional bending adjustment.
[0053] Independently or additionally, the guide sheath is provided with a braided mesh inside the tube. The tube is made of different soft and hard materials to form a hardness difference between the bending section where the visualization electrode ring 31 is provided and the rear end of the tube, thereby increasing the bending function and effect. The entire tube is provided with a braided mesh to enhance the support effect of the tube pushing and bending. The bidirectional bending of the sheath head can be controlled by the axial movement of the first rack 104.
[0054] Independently or additionally, a fixing block 108 is provided at one end of the first rack 104 facing the head end of the guide sheath. Protrusions 109 are provided on both sides of the fixing block 108. A groove is provided in the cover of the handle housing 102 corresponding to the position of the protrusions 109, forming an elongated slot 113 after the cover is closed, allowing the protrusions 109 to move along the elongated slot. The front end of the handle housing 102 also serves to limit the fixing block 108. For example... Figure 5In the gear sleeve 110, the width of the internal thread is adapted to the size of the protrusion. The other end is covered by the front cover. The protrusion 109 extends out of the handle housing and is embedded in the internal thread of the gear sleeve. The axial position of the protrusion 109 is determined according to the pattern of the internal thread, so that the protrusions on both sides of the fixing block 108 are embedded in the internal thread of the gear sleeve. By rotating the gear sleeve 110, the columnar fixing block 108 and the first rack 104 in the handle housing are moved axially as a whole, thereby controlling the bidirectional bending of the sheath head.
[0055] Independently or additionally, a gear sleeve 110 is fitted on the front end of the handle housing 102, and a bending gear 111 or a circumferential gear 112 is provided on the gear sleeve 110. The circumferential gear 112 or the bending gear 111 is fitted on the outside of the handle housing 102, and the required action is performed by driving the corresponding gear.
[0056] like Figure 5 As shown, the bending gear 111 and the circumferential gear 112 are both embedded in the adapted surgical robot actuator. The surgical robot can control the bidirectional bending of the sheath head by driving the rotation of the bending gear, and control the circumferential rotation of the entire sheath by simultaneously driving the rotation of the bending gear and the rotating gear. At the same time, the two gears also serve as fixed frames for axial movement, and the axial movement of the actuator drives the axial movement of the entire sheath.
[0057] Independently or additionally, the other end of the handle of the tail wire guide component 2 is also 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 on 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.
[0058] In a specific example, an electrode ring wire and a saline tube are connected to the side of the handle end. 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 electrode ring wire and saline tube are guided in a regular manner by the tail wire guiding component, so that they are regularly wound on the handle. Figure 6 The electrode ring wires and saline tubing are shown regularly wound around the sheath handle, and the sheath is in its initial state, as shown. Figure 6 As shown, the tail wire guide component 2 includes a guide slot 23 and an anti-winding baffle 24 disposed on the side of the guide sheath tube, wherein the guide slot 23 includes an electrode tail wire guide slot and a saline pipeline guide slot.
[0059] In a specific example, two guide slots are set on the side of the handle at a 90° angle to the handle's tail line, with the handle axis as the center. The axial position of the guide slots is half a tube length ahead of the corresponding tail line of the handle and the position of the saline tube, respectively, so that the guide electrode ring wire and the saline tube are regularly wound around the handle in a fixed direction.
[0060] like Figure 7 As shown, anti-winding baffles 24 are also provided on the electrode ring wire and the brine tube near the end of the handle to restrict the electrode ring wire and the brine tube from winding in a fixed direction and prevent reverse winding. At the same time, they also serve to isolate the electrode ring wire. When the electrode ring wire or the brine tube on the sheath handle has multiple turns, the electrode ring wire and the brine tube will not become entangled with each other, causing machine malfunctions and errors.
[0061] Independently or additionally, a hemostatic valve assembly 20 is provided at the other end of the handle of the tail wire guide component 2. For example... Figure 7 As shown, the hemostatic valve assembly 20 is fixed to the rear end of the handle. When it is necessary to change the catheter interventional instruments during the operation, the hemostatic valve can prevent blood from flowing out of the sheath tail. The sheath can be fixed as a whole to the actuator of the surgical robot, and the catheter can be replaced without removing the sheath from the surgical robot actuator. This avoids the manual operation of the sheath and the instrument assembly and switching between the robot operation, reduces operation time, improves surgical efficiency, and facilitates the promotion and application of surgical robot procedures.
[0062] Independently or additionally, the guide sheath is provided with a wiring groove 33 for leading out the wires of the visualization electrode ring 31, and the guide sheath head end of the wiring groove 33 is provided with a negative pressure prevention micropore 32.
[0063] like Figure 8 As shown in some specific examples, the guide sheath has an irregular, flat structure with a routing groove 33 on it. This facilitates the arrangement of the electrode ring leads and reduces the overall outer diameter and protrusion of the lumen. During the sheath forming process, the electrode leads pass through the routing groove, and a layer of water coating is applied to the outside of the sheath to form a smooth body, preventing damage to peripheral blood vessels during axial movement of the sheath. The electrode ring signal line passes through the routing groove 33 on the sheath body and is connected to an electrophysiological three-dimensional mapping system at the tail. Under both DSA angiography and the three-dimensional mapping system, the position and curvature of the sheath tip can be visualized. The surgeon can simultaneously see the relative position and corresponding curvature of the sheath tip and the catheter tip in the three-dimensional mapping system, gaining a more intuitive understanding of the current status of the catheter and sheath, as well as their relative position to the target ablation point. This facilitates the surgeon's understanding of the next surgical instructions, improves surgical efficiency, reduces surgical difficulty, and significantly shortens the surgeon's culture period.
[0064] In some other examples, the sheath tip is designed with a bend and a pointed tip to facilitate the sheath's entry into a specific location within the heart chamber. The sheath tip also integrates a negative pressure-preventing micropore 32. When the sheath contacts the inner wall of the heart, the catheter can easily create a negative pressure space at the sheath tip when it is withdrawn from the sheath. The negative pressure can be released through the negative pressure-preventing micropore, thus preventing damage to the inner wall of the heart when the catheter is withdrawn from the sheath.
[0065] In summary, the multi-electrode device at the sheath tip of this application can visualize the position and status of the sheath tip under DSA angiography and three-dimensional mapping systems, which can assist in cardiac interventional surgery and solve the problem that traditional fixed curved guide sheaths are not visible under three-dimensional navigation systems. During the operation, the surgeon can be more intuitively guided to perform the next surgical operation by controlling the sheath with the surgical robot.
[0066] The saline tubing and wire guiding structure of the device in this application allows the saline tubing and wires at the sheath handle to be regularly wound around the handle during rotational operation, preventing jamming of the surgical robot, solving the problem of surgical safety caused by wire and saline tubing entanglement during surgery, and resolving the surgical risks caused by this.
[0067] This application incorporates a double-rack bending structure within the handle, which is connected to the fixing ring at the sheath head end via a traction steel wire. By utilizing the relative motion relationship between the first and second racks, the front end of the tube is subjected to unilateral force bending, thereby controlling the bidirectional bending of the sheath head end with a control precision of up to 1°.
[0068] The tip-forming and anti-negative-pressure microporous design of the device tube in this application solves the problem of negative pressure damaging heart tissue when the sheath directly contacts the cardiac endothelial tissue of conventional catheters; at the same time, it solves the problem of sheath damage to the blood vessel wall when passing through peripheral blood vessels.
[0069] The device of this application features a sheath with a shaped tip and a bend to facilitate insertion of the sheath into a specific position in the heart chamber. The front end of the sheath also integrates anti-negative pressure micropores. When the sheath contacts the inner wall of the heart, the catheter retracts within the sheath, creating a negative pressure space. The negative pressure can be released through the anti-negative pressure micropores, preventing damage to the inner wall of the heart when manipulating the catheter.
[0070] The sheath handle of this application is a dedicated handle for interventional surgical robots. The handle end is equipped with a mechanical transmission component, which allows the surgical robot to control the sheath for circumferential rotation and axial movement without the need for an additional adapter. The axial movement accuracy can reach sub-millimeter level accuracy, far exceeding that of manual movement. At the same time, it can achieve high-precision rotation control. When performing catheter operations in local cardiac locations, the sheath device of this invention can achieve high-precision quantitative operation.
[0071] It should be noted that, in the embodiments of this application, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes that element.
[0072] The sequence numbers of the embodiments in this application are for descriptive purposes only and do not represent the superiority or inferiority of the embodiments.
[0073] The embodiments of this application have been described above with reference to the accompanying drawings. However, this application is not limited to the specific embodiments described above. The specific embodiments described above are merely illustrative and not restrictive. Those skilled in the art can make many other forms under the guidance of this application without departing from the spirit and scope of the claims. All of these forms are within the protection scope of this application.
Claims
1. A remote intracardiac adjustable bendable sheath device, characterized in that, include: 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 guide the electrode ring wire (21) and the saline tube (22) in a regular manner during the calibration process. The electrode ring wire (21) is electrically connected to the visualization electrode ring (31) of the visualization component (3) to connect to the calibration system. The saline tube (22) is connected to the guide sheath to provide saline during the calibration process. A mechanical transmission component (1) is disposed on one end of the handle, and the other end of the mechanical transmission component (1) leads out of the guide sheath. The mechanical transmission component (1) is used to control the guide sheath to perform the required movement and / or bending action based on a gear structure. The visualization component (3), based on the guide sheath, includes at least four visualization electrode rings (31), which are axially spaced at the head end of the guide sheath, and the visualization electrode rings (31) lead out the electrode ring wires (21).
2. The remote intracardiac adjustable bendable sheath device as described in claim 1, characterized in that, The mechanical transmission component (1) specifically includes: The handle housing (102) is a cover structure; A double rack bending structure (101) is disposed inside the handle housing (102), including a first rack (104), a second rack (105), and a rotating gear (106). The rotating gear (106) is rotatably sleeved inside the handle housing (102). The first rack (104) and the second rack (105) are disposed opposite to each other in the rack groove (103) and both mesh with the rotating gear (106) so that the traction wire of the guide sheath can be driven to complete the bending action based on the rotation of the rotating gear (106).
3. The remote intracardiac adjustable bendable sheath device as described in claim 2, characterized in that, The guide sheath contains two traction wires. The first rack (104) and the second rack (105) are respectively provided with traction wire fixing holes (107). One end of the two traction wires is connected to the fixing rings on both sides of the guide sheath head end, and the other end is respectively connected to the traction wire fixing holes (107) so that the corresponding traction wires are drawn out under the movement of the first rack and the second rack, so that the guide sheath head end bends and completes the bending action.
4. The remote intracardiac adjustable bendable sheath device as described in claim 3, characterized in that, The guide sheath has a braided mesh inside, and the guide sheath is made of different soft and hard materials to form a hardness difference between the bending section where the visualization electrode ring (31) is set and the rear end of the tube.
5. The remote intracardiac adjustable bendable sheath device as described in claim 3, characterized in that, The first rack (104) has a fixing block (108) at one end facing the head end of the guide sheath. The fixing block (108) has protrusions (109) on both sides. The handle housing (102) has a groove corresponding to the position of the protrusions (109) in the cover, and forms an elongated slot (113) after the cover is closed, so that the protrusions (109) can move along the elongated slot. The front end of the handle housing (102) is also used to limit the fixing block (108).
6. The remote intracardiac adjustable bendable sheath device as described in claim 5, characterized in that, The handle housing (102) is fitted with a gear sleeve (110) at the front end. The gear sleeve (110) is provided with a bending gear (111) or a circumferential gear (112). The handle housing (102) is fitted with a circumferential gear (112) or a bending gear (111). The required action is performed by driving the corresponding gear.
7. The remote intracardiac adjustable bendable sheath device as described in claim 1, characterized in that, The other end of the handle of the tail wire guide component (2) is also 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 on 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) respectively.
8. The remote intracardiac adjustable bendable sheath device as described in claim 7, characterized in that, The other end of the handle of the tail wire guide component (2) is provided with a hemostatic valve assembly (20).
9. The remote intracardiac adjustable bendable sheath device as described in claim 1, characterized in that, The guide sheath is provided with a wiring groove (33) for leading out the wires of the visualization electrode ring (31). The guide sheath head is provided with a negative pressure micropore (32) in the wiring groove (33).