Positioning sheath and sheath positioning system

Abstract

A positioning sheath and sheath positioning system are disclosed. The positioning sheath includes a sheath body, a magnetic sensor, a ring electrode, and a tail wire socket. The sheath body includes a main body segment, a bending segment, and a distal head segment connected sequentially from proximal to distal. At least two magnetic sensors are present, with at least one sensor installed at the proximal and distal ends of the bending segment. At least one ring electrode is installed in the bending segment. The tail wire socket is installed at the proximal end of the main body segment and is electrically connected to the magnetic sensor and the ring electrode. In this application, the positioning sheath integrates a magnetic sensor for positioning and modeling, and a ring electrode for mapping and display. It can be independently displayed during surgery, enabling the construction of a three-dimensional model of the cardiac chamber without relying on a magnetic positioning catheter. Furthermore, when the magnetic positioning catheter passes through the positioning sheath, the relative position of the positioning sheath and the catheter can be accurately displayed, allowing the surgeon to intuitively understand the catheter's movement path, optimize the rationality of the treatment plan, and improve surgical efficiency and safety.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more particularly to a positioning sheath and a sheath positioning system. Background Technology

[0002] Cardiovascular disease is a major public health problem facing both globally and in China, with high morbidity, disability, and mortality rates, seriously threatening human health. Minimally invasive interventional surgery has become one of the effective means of treating this disease in clinical practice. As an important instrument in this type of surgery, the sheath (also known as a catheter sheath or sheath system) provides intravascular access for various catheters during the procedure, assisting the catheters in reaching the lesion site for diagnosis and treatment.

[0003] Currently, the sheaths used in electrophysiological interventional surgeries both domestically and internationally are primarily two-dimensional imaging sheaths. This means that the sheath's location within the heart is determined by the imaging point at its distal end under X-ray. For complex procedures, frequent suture verification is necessary, increasing radiation exposure for both doctors and patients and reducing surgical efficiency. Furthermore, for atrial septal puncture requiring the establishment of a left atrial passage, X-rays cannot directly pinpoint the location of the fossa ovalis, and there is a lack of precise three-dimensional structural indication. In cases of patient cardiac abnormalities or insufficient X-ray machine clarity, this severely impacts the success rate and safety of the puncture.

[0004] In recent years, sheaths capable of three-dimensional display have emerged, allowing the position and shape of the sheath to be displayed in real time on a three-dimensional device via sheath electrodes. However, the sheath cannot be displayed independently; it requires a magnetic positioning catheter to first establish a three-dimensional matrix within the cardiac chamber, and then the three-dimensional display is achieved through the electrical positioning function of the sheath electrodes. Surgical convenience, sheath display accuracy, and other aspects need further improvement.

[0005] Therefore, how to improve the technical defects existing in the prior art has always been a problem that ordinary people skilled in the art need to solve. Utility Model Content

[0006] The purpose of this application is to provide a positioning sheath and a sheath positioning system, which can be independently displayed during the operation, and helps the catheter to reach the specific site smoothly and quickly for diagnosis and treatment under low or even zero X-ray conditions, thereby improving surgical efficiency and safety.

[0007] The technical solution provided by this utility model is as follows:

[0008] A positioning sheath, comprising:

[0009] The sheath body comprises a main body segment, a bending segment, and a distal head segment connected sequentially from the proximal end to the distal end.

[0010] Magnetic sensors, the number of which is at least two, and at least one magnetic sensor is installed at the far end and the near end of the bending section respectively;

[0011] An annular electrode, with at least one annular electrode, is installed in the bending section;

[0012] The tail wire socket is installed near the main body section and is electrically connected to the magnetic sensor and the ring electrode.

[0013] In some embodiments, the sheath body has a wire cavity that extends axially through the sheath body to accommodate the wires of the magnetic sensor and the ring electrode.

[0014] In some implementations, there are two magnetic sensors, including a first magnetic sensor installed at the far end of the bending section and a second magnetic sensor installed at the near end of the bending section.

[0015] There are two lead cavities, including a first lead cavity and a second lead cavity;

[0016] The wires of the first magnetic sensor and the annular electrode are passed through the first wire cavity, and the wires of the second magnetic sensor are passed through the second wire cavity; or, the wires of the first magnetic sensor and the second magnetic sensor are passed through the first wire cavity, and the wires of the annular electrode are passed through the second wire cavity.

[0017] In some embodiments, the first guide cavity and the second guide cavity are arranged symmetrically along the central axis of the sheath body.

[0018] In some embodiments, a pull wire ring is installed at the distal end of the bending section. The pull wire ring is located on the proximal side of the first magnetic sensor. At least two pull wires are provided at the proximal end of the pull wire ring, and the pull wires extend to the proximal end of the sheath body.

[0019] A bend control handle is installed near the proximal end of the sheath body, and the bend control handle is configured to be suitable for pulling the cable.

[0020] In some embodiments, the sheath body is provided with a pull wire cavity, which extends axially through the sheath body and is provided with pull wires corresponding to each other to accommodate the pull wires.

[0021] In some embodiments, the sheath body includes an inner tube, a braided layer, and an outer tube, which are sequentially sleeved from the inside to the outside.

[0022] A pull ring is fitted onto the inner tube. The first magnetic sensor, the wire cavity, and the pull cavity are fixed to the outer wall of the inner tube. The second magnetic sensor is fixed to the outer wall of the inner tube, the outer wall of the wire cavity, the outer wall of the pull cavity, or the outer wall of the braided layer.

[0023] In some embodiments, a hemostatic valve is provided at the proximal end of the sheath body. The hemostatic valve is located inside the bending handle, and a tube body is connected to the proximal end of the hemostatic valve. The end of the tube body away from the hemostatic valve extends out from inside the bending handle.

[0024] In some embodiments, the distal end has at least one side hole that connects to the inside of the inner tube; and a three-way valve is connected to the end of the tube body away from the hemostatic valve.

[0025] This application also provides a sheath positioning system, comprising:

[0026] The positioning processing unit, the display unit, and the positioning sheath provided in any of the above embodiments;

[0027] The tail wire socket is electrically connected to the positioning processing unit via a cable. The positioning processing unit is configured to acquire the position information of the magnetic sensor and the ring electrode, and transmit the position information to the display unit. The display unit is configured to receive the position information and output image information of the positioning sheath based on the position information.

[0028] The technical advantages of this application are as follows:

[0029] 1. This application integrates the positioning and modeling functions of the magnetic sensor and the mapping and display functions of the ring electrode by setting a magnetic sensor and a ring electrode in the sheath body. In this way, the positioning sheath can complete the construction of a three-dimensional model of the heart chamber without the assistance of a magnetic positioning catheter, thus simplifying the surgical procedure.

[0030] 2. In this application, at least one magnetic sensor is installed at the distal and proximal ends of the bending segment. When used in conjunction with a compatible 3D device, it can accurately display the position and shape of the distal tip of the positioning sheath and the bending segment within the cardiac chamber in real time. When the magnetically positioned catheter passes through the positioning sheath, it can also accurately display the relative position of the sheath and the catheter, allowing the surgeon to intuitively understand the catheter's movement path, optimize the rationality of the treatment plan, and improve surgical efficiency and safety.

[0031] 3. In this application, the ring electrode is installed in the bending section. It is matched and calibrated by its impedance information and the position information of the magnetic sensor. It can perform ECG signal mapping and electrode visualization in the three-dimensional positioning system. With the magnetic sensors at the distal and proximal ends of the bending section, it is convenient for the operator to grasp the position of the positioning sheath and the expected bending direction in real time.

[0032] 4. In this application, there are two magnetic sensors, including a first magnetic sensor installed at the far end of the bending section and a second magnetic sensor installed at the near end of the bending section. This ensures that the operator can monitor the position of the positioning sheath and the expected bending direction in real time, while also reducing the impact on the first and second magnetic sensors when the positioning sheath is bent. This reduces the risk of damage to the magnetic sensors and the outer tube, and ensures the reliability of magnetic positioning. Attached Figure Description

[0033] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments:

[0034] Figure 1 This is a schematic diagram of the positioning sheath provided in one embodiment of the present application;

[0035] Figure 2 This is a cross-sectional view of the sheath body provided in one embodiment of this application;

[0036] Figure 3 This is an internal structural view of the sheath body provided in one embodiment of this application;

[0037] Figure 4 This is an internal structural view of the sheath body provided in another embodiment of this application;

[0038] Figure 5 This is an internal structural view of the sheath body provided in yet another embodiment of this application;

[0039] Figure 6 This is a schematic diagram of a sheath positioning system provided in one embodiment of this application;

[0040] Figure 7 This is a three-dimensional schematic diagram of a sheath positioning system provided in one embodiment of this application.

[0041] Figure label:

[0042] 100. Sheath body; 110. Main body section; 120. Transition section; 130. Bending section; 131. Pull ring; 140. Distal end section; 141. Side hole; 151. First guide tube cavity; 152. Second guide tube cavity; 160. Pull tube cavity; 170. Inner tube; 180. Braided layer; 190. Outer tube;

[0043] 210. First magnetic sensor; 220. Second magnetic sensor;

[0044] 300. Ring electrode;

[0045] 400. Bending handle; 410. Tail cable socket; 420. Pipe body; 421. Three-way valve;

[0046] 500. Positioning processing unit;

[0047] 600. Display unit;

[0048] 700. Cables;

[0049] 800. Equipment connector;

[0050] 900, catheter. Detailed Implementation

[0051] In the following description, specific details such as particular system architectures and techniques are set forth for illustrative purposes and not for limitation, in order to provide a thorough understanding of the embodiments of this application. However, those skilled in the art will understand that this application can also be implemented in other embodiments without these specific details. In other instances, detailed descriptions of well-known systems, apparatuses, circuits, and methods have been omitted so as not to obscure the description of this application with unnecessary detail.

[0052] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the specific implementation methods of this application will be described below with reference to the accompanying drawings. Obviously, the drawings described below are merely some embodiments of this application. For those skilled in the art, other drawings and other implementation methods can be obtained based on these drawings without any creative effort.

[0053] To keep the drawings concise, each drawing only schematically shows the parts relevant to this application, and they do not represent the actual structure of the product. Furthermore, for ease of understanding, in some drawings, only one of the components with the same structure or function is schematically shown, or only one is labeled. In this document, "one" not only means "only one," but can also mean "more than one."

[0054] It should also be further understood that the term “and / or” as used in this application specification and the appended claims means any combination of one or more of the associated listed items and all possible combinations, and includes such combinations.

[0055] In this document, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium; and they can refer to the internal connection between two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0056] In the embodiments shown in the accompanying drawings, the directional indications (such as up, down, left, right, front, and back) used to explain the structure and movement of the various components of this application are relative rather than absolute. These descriptions are appropriate when these components are in the positions shown in the drawings. If the description of the positions of these components changes, these directional indications also change accordingly.

[0057] Furthermore, in the description of this application, the terms "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0058] The sheath is a crucial instrument in interventional medical procedures, primarily used to establish stable vascular or cavitary access, facilitating the insertion and removal of catheters, guidewires, balloons, stents, and other devices. Currently, the sheaths used in electrophysiological interventional procedures both domestically and internationally are mostly two-dimensional, meaning their location in the heart is determined by the visual points at the distal end of the sheath under X-ray. This method has poor display accuracy and can cause varying degrees of harm to both the doctor and the patient. Although sheaths capable of three-dimensional display have emerged in recent years, allowing the sheath's position and shape to be displayed in real-time on a three-dimensional device via sheath electrodes, these sheaths cannot be displayed independently. They require a magnetically positioned catheter to first establish a three-dimensional matrix within the heart chambers, and then the three-dimensional display is achieved through the electropositional function of the sheath electrodes.

[0059] In response, this application discloses a positioning sheath that can be independently displayed during surgery, allowing the auxiliary catheter to smoothly and quickly reach specific sites for diagnosis and treatment under low or even zero X-ray conditions, thereby improving surgical efficiency and safety.

[0060] In one specific embodiment, see Figure 1 , Figure 3 and Figure 7 The positioning sheath includes a sheath body 100, magnetic sensors, a ring electrode 300, and a tail wire socket 410. The sheath body 100 comprises a main segment 110, a bending segment 130, and a distal tip segment 140 connected sequentially from proximal to distal. The main segment 110 is made of a high-polymer material with a certain degree of rigidity to facilitate the establishment of an intravascular access by the sheath body 100 and provide sufficient radial support for the catheter 900. The bending segment 130 is made of a flexible high-polymer material, facilitating bending and thus better assisting the catheter 900 in flexibly reaching the desired position within the heart chamber for proper contact. At least two magnetic sensors are present, with at least one installed at the distal and one at the proximal end of the bending segment 130. The position, orientation, or movement of the bending segment 130 can be determined by detecting changes in the magnetic field or bioimpedance. At least one ring electrode 300 is installed in the bending segment 130 to assist in the construction of a three-dimensional model within the heart chamber. The tail wire socket 410 is installed at the proximal end of the main body section 110 and is electrically connected to the magnetic sensor and the ring electrode 300 for docking with external three-dimensional equipment. The operator can intuitively understand the treatment path of the catheter 900 through the external three-dimensional equipment.

[0061] This embodiment integrates a magnetic sensor for positioning and modeling, and a ring electrode 300 for mapping and display on the sheath body 100. When used with compatible 3D equipment, it enables visualization of the positioning sheath without the aid of X-rays or a magnetically positioned catheter. Compared to traditional two-dimensional imaging sheaths, the positioning sheath helps surgeons intuitively understand the surgical path and assists the catheter 900 in reaching specific sites smoothly and quickly for diagnosis and treatment in low-X-ray or even zero-X-ray environments, improving surgical efficiency and reducing radiation damage. Compared to electrically positioned 3D display sheaths, the positioning sheath can complete the construction of intracardiac 3D models without the aid of magnetically positioned catheters, simplifying the surgical procedure, providing higher positioning accuracy, and superior 3D display accuracy.

[0062] Because the bending section 130 and the main body section 110 have different hardness requirements, in this embodiment, the sheath body 100 may further include a transition section 120. The transition section 120 is located between the bending section 130 and the main body section 110 and is made of a polymer material with gradually varying hardness, serving as a transition connection. At this time, the magnetic sensor located near the bending section 130 is correspondingly installed at the connection between the bending section 130 and the transition section 120.

[0063] Conversely, a magnetic sensor located at the distal end of the bending section 130 is installed at the connection between the bending section 130 and the distal head section 140. In addition to determining the position, direction or movement of the bending section 130, the magnetic sensor can also determine the position, direction or movement of the distal head section 140, and determine the relative position of the positioning sheath and the catheter 900 when the magnetic positioning catheter passes through the positioning sheath. This allows the surgeon to intuitively understand the movement path of the catheter 900, optimize the rationality of the treatment plan, and improve surgical efficiency and safety.

[0064] In this embodiment, the main body segment 110 can also be made of a polymer material with gradually varying hardness. In this case, the transition segment 120 and the main body segment 110 can be regarded as a whole made of a polymer material with gradually varying hardness.

[0065] Specifically, each annular electrode 300 and magnetic sensor is connected to a wire. To improve the structural rationality of the positioning sheath and protect the wire from damage, the sheath body 100 may be provided with a wire cavity. The wire cavity extends axially through the sheath body 100 to accommodate the wires of the magnetic sensor and the annular electrode 300. After the wire extends from the proximal end of the sheath body 100, it is connected to the tail wire socket 410 by welding or other methods. After the tail wire socket 410 is connected to an external three-dimensional device, functions such as visualization of the positioning sheath are realized.

[0066] In one example embodiment, see Figures 1 to 3The system employs two magnetic sensors: a first magnetic sensor 210 installed at the distal end of the bending section 130 (corresponding to the proximal end of the distal head section 140) and a second magnetic sensor 220 installed at the proximal end of the bending section 130 (corresponding to the distal end of the transition section 120). The first magnetic sensor 210 is used to locate the position and orientation of the distal head section 140, and the second magnetic sensor 220 is used to locate the position and orientation of the transition section 120. Furthermore, based on the position and orientation information corresponding to the first magnetic sensor 210 and the second magnetic sensor 220, the spatial position and orientation information of the adjustable bending section 130 can be obtained. Combined with the annular electrode 300 installed on the bending section 130, this allows the surgeon to monitor the position and expected bending direction of the positioning sheath in real time.

[0067] This embodiment achieves visualization of the positioning sheath by using a minimum number of magnetic sensors in conjunction with the annular electrode 300, resulting in a more reasonable structural design and lower cost. Furthermore, the first magnetic sensor 210 and the second magnetic sensor 220 are located at the axial ends of the bending section 130, making them less susceptible to the effects of bending of the bending section 130. This reduces the risk of magnetic sensor damage caused by bending of the bending section 130 during controlled bending operations, ensuring the reliability of magnetic positioning.

[0068] Conversely, the number of annular electrodes 300 can also be two, and the two annular electrodes 300 are arranged sequentially along the axial direction of the sheath body 100 for ECG signal mapping and electrode visualization in three-dimensional display. The number of lead cavities is also two, including a first lead cavity 151 and a second lead cavity 152. The lead wires of the first magnetic sensor 210 and the annular electrode 300 pass through the first lead cavity 151, and the lead wires of the second magnetic sensor 220 pass through the second lead cavity 152. Of course, in actual production, the lead wires of the first magnetic sensor 210 and the second magnetic sensor 220 can both pass through the first lead cavity 151, and the lead wires of the annular electrode 300 can pass through the second lead cavity 152.

[0069] As a preferred option, see Figure 2 The first guide cavity 151 and the second guide cavity 152 are arranged symmetrically along the central axis of the sheath body 100.

[0070] Further, see Figure 1 and Figure 3 A pull-wire ring 131 is also installed at the distal end of the bending section 130. The pull-wire ring 131 is located on the proximal side of the first magnetic sensor 210. At least two pull wires are provided at the proximal end of the pull-wire ring 131. The pull wires extend to the proximal end of the sheath body 100. A bending control handle 400 is installed at the proximal end of the sheath body 100. The bending control handle 400 is preferably made of polycarbonate material and is configured to pull the pull wires so that the operator can push, twist, and bend the positioning sheath, and assist the catheter 900 in adapting to different physiological and anatomical shapes.

[0071] Specifically, see Figure 2 The pull ring 131 is equipped with two pull wires, and the two pull wires are symmetrically arranged with respect to the central axis of the pull ring 131. By controlling the bending control handle 400, the operator can make the bending section 130 form a unidirectional or bidirectional (roughly symmetrical) bend to assist the catheter 900 in flexibly reaching the required position in the heart chamber for good fit.

[0072] In this embodiment, the sheath body 100 is provided with a pull wire cavity 160, which extends through the sheath body 100 along the axial direction and is arranged one-to-one with the two pull wires on the pull wire ring 131 (arranged symmetrically with respect to the sheath body 100) to accommodate the two pull wires respectively. The two pull wires are preferably made of metal.

[0073] In one specific embodiment, see Figure 1 and Figure 2 The sheath body 100 includes an inner tube 170, a braided layer 180, and an outer tube 190, which are sequentially fitted from the inside out. The inner tube 170 is preferably made of a polymer material, providing excellent lubricity and significantly reducing frictional resistance when the catheter 900 moves within the positioning sheath, making it suitable for tortuous blood vessels or long-distance delivery. The braided layer 180 is made of metal, ensuring good shape retention and guaranteeing that the positioning sheath, especially the bending section 130, maintains its original structure even after repeated bending and twisting. The outer tube 190 is preferably made of a polymer material with its hardness arranged in a specific pattern, providing sufficient radial support for the catheter 900.

[0074] A pull ring 131 is fitted onto the outer wall of the inner tube 170 and connected to the distal end of the braided layer 180; both the pull cavity 160 and the wire cavity are fixed to the outer wall of the inner tube 170 and located between the inner tube 170 and the braided layer 180; the first magnetic sensor 210 is fixed to the outer wall of the inner tube 170 and the second magnetic sensor 220 is fixed between the inner tube 170 and the outer tube 190.

[0075] For example, see Figure 2 and Figure 3 Both the first magnetic sensor 210 and the second magnetic sensor 220 can be fixed to the outer wall of the inner tube 170 by means of bonding or other methods. At this time, the wires of the first magnetic sensor 210 and the annular electrode 300 can be placed in the first wire cavity 151, while the wires of the second magnetic sensor 220 are placed in the second wire cavity 152. In the actual manufacturing process of this embodiment, the second magnetic sensor 220 should be installed first, followed by the fixing of the wire cavity 160 and the wire cavities (first wire cavity 151 and second wire cavity 152). The first magnetic sensor 210 should be installed after the braided layer 180 is completed, which helps to maintain the dimensional stability of the positioning sheath.

[0076] Or see Figure 2 and Figure 4 The second magnetic sensor 220 can also be fixed to the outer layer of the draw wire cavity 160 and / or the wire cavity (first wire cavity 151, second wire cavity 152). In this case, the wires of the first magnetic sensor 210 and the annular electrode 300 are simultaneously placed in the first wire cavity 151, and the wires of the second magnetic sensor 220 are placed in the second wire cavity 152. In the actual manufacturing process of this embodiment, the draw wire cavity 160 and the wire cavity are fixed first, and then the second magnetic sensor 220 is installed. The first magnetic sensor 210 is installed after the braided layer 180 is completed. This helps to maintain the straightness of the draw wire cavity 160 and the wire cavity and reduce the resistance when the draw wire and the wire are inserted.

[0077] In addition, see Figure 2 and Figure 5 The second magnetic sensor 220 can also be fixed to the outer layer of the braided layer 180. At this time, the wires of the first magnetic sensor 210 and the second magnetic sensor 220 are simultaneously placed in the first wire cavity 151, and the wire of the annular electrode 300 is placed in the second wire cavity 152. In the actual manufacturing process of this embodiment, the fixing of the wire cavity 160 and the wire cavities (first wire cavity 151, second wire cavity 152) and the fabrication of the braided layer 180 are completed first, and then the first magnetic sensor 210 and the second magnetic sensor 220 are installed. The welding position of the first magnetic sensor 210, the second magnetic sensor 220 and the wire is preferably fixed with a polymer protective tube of a certain length. On the one hand, this can prevent the wire from separating from the corresponding magnetic sensor at the welding point, and on the other hand, it can isolate the uninsulated section of the wire from the braided layer 180, reducing the risk of poor insulation of the positioning sheath.

[0078] Specifically, see Figure 1 The proximal end of the sheath body 100 is also equipped with a hemostatic valve. This hemostatic valve is made of materials such as silicone and is fixed to the proximal end of the sheath body 100 by means of bonding or other methods and placed inside the bending control handle 400. It can provide a good sealing effect when instruments such as the catheter 900 enter and exit, reduce intraoperative blood loss, and reduce the risk of air entering the positioning sheath and forming an air embolism.

[0079] Furthermore, a tube 420 is connected to the proximal end of the hemostatic valve. The tube 420 is a flexible polymer single-lumen tube. The end of the tube furthest from the hemostatic valve extends into the self-controlled bending handle 400 and is connected to a three-way valve 421, so that the operator can perform aspiration, fluid resuscitation and other operations during the operation.

[0080] In this embodiment, see Figure 1 and Figure 2 At least one side hole 141 is provided at the distal end of the head section 140. The side hole 141 is connected to the inside of the inner tube 170, which helps to ensure the stable progress of intraoperative operations such as aspiration, fluid resuscitation, blood sampling and pressure monitoring.

[0081] In a preferred embodiment, the tail wire socket 410 may also be integrated into the inside of the bend control handle 400 and extend out from the inside of the bend control handle 400; and the tail wire socket 410 is exposed on the wire portion of the bend control handle 400, and its exterior is preferably covered with a flexible polymer tube for protection.

[0082] See Figure 1 , Figure 6 and Figure 7 This application also provides a sheath positioning system, including a positioning processing unit 500, a display unit 600, and the positioning sheath provided in any of the above embodiments. A tail wire socket 410 is electrically connected to the positioning processing unit 500 via a cable 700. The positioning processing unit 500 is configured to acquire position information of the magnetic sensor and the ring electrode 300, and transmit the position information to the display unit 600. The display unit 600 is configured to receive the position information and output image information of the positioning sheath based on the position information.

[0083] Taking a magnetic sensor comprising a first magnetic sensor 210 installed at the distal end of the bending section 130 (corresponding to the proximal end of the distal head section 140) and a second magnetic sensor 220 installed at the proximal end of the bending section 130 (corresponding to the distal end of the transition section 120) as an example, in practical applications, when the positioning sheath moves in the ultra-low magnetic field generated by the magnetic field generator, the first magnetic sensor 210 and the second magnetic sensor 220 cut the magnetic field lines to generate a weak current. This current is collected and processed by the positioning processing unit 500 to obtain the spatial position and orientation information of the first magnetic sensor 210 and the second magnetic sensor 220. When the annular electrode 300 on the positioning sheath moves in the low-voltage electric field applied externally, it can collect cardiac electrophysiological signals, and through matching and calibration using the position information of the first magnetic sensor 210 and the second magnetic sensor 220 and the impedance information of the positioning sheath electrode, the spatial position information of the annular electrode 300 is calculated. The positioning processing unit 500, combined with the known dimensions of the positioning sheath, can perform image processing on the spatial position and orientation information of the distal tip 140, the bending section 130, and the annular electrode 300 to obtain a real-time three-dimensional display image of the positioning sheath. The display unit 600, connected to the positioning processing unit 500, can receive and display the image-processed spatial position and orientation information, accurately showing the position and shape of the distal tip 140, the bending section 130, and the annular electrode 300, facilitating the surgeon's real-time monitoring of the sheath's position and expected bending direction. Furthermore, when the catheter 900 with a magnetic sensor (magnetic positioning catheter) passes through the positioning sheath, the relative position of the positioning sheath and catheter 900 can be accurately displayed, allowing the surgeon to intuitively understand the catheter 900's movement path, optimize the rationality of the treatment plan, and improve surgical efficiency and safety.

[0084] In this embodiment, when performing interventional surgery using a magnetic sensor and a three-dimensional positioning system, the positioning sheath can directly perform three-dimensional modeling of the cardiac chamber without relying on the magnetic positioning catheter. The annular electrode 300 can perform electrocardiogram signal mapping and electrode visualization, thereby accurately displaying the position and shape of the distal tip 140 and the bending section 130 of the positioning sheath, as well as the relative position of the positioning sheath and the catheter 900, in the three-dimensional positioning system. The operator can monitor the position and expected bending direction of the positioning sheath in real time without the aid of X-rays, intuitively understand the treatment path of the catheter 900, and quickly and accurately assist the catheter 900 to reach the required part of the cardiac chamber by pushing, twisting, and controlling the bending of the positioning sheath, effectively improving the efficiency and safety of the operation.

[0085] Furthermore, the sheath positioning system also includes a device connector 800, which is used to electrically connect the cable 700 and the positioning processing unit 500, thereby enabling the connection of the first magnetic sensor 210, the second magnetic sensor 220, the ring electrode 300 and the positioning processing unit 500.

[0086] Taking atrial septal puncture as an example, the clinical application process of the sheath positioning system disclosed in this embodiment is as follows: S1. Prepare the femoral vein approach and place the positioning sheath into the right atrium. S2. Using the first magnetic sensor 210, the second magnetic sensor 220, and the ring electrode 300, construct a three-dimensional model of the right atrium. S3. Confirm the location of the fossa ovalis based on the three-dimensional model, insert the dilator and atrial septal puncture needle into the positioning sheath, and complete the atrial septal puncture. S4. Push the positioning sheath forward and observe the distal straight segment of the positioning sheath passing through the fossa ovalis and entering the left atrium. Once the electrophysiological signal collected by the ring electrode 300 changes from a right atrial signal to a left atrial signal, withdraw the dilator and the atrial septal puncture needle. S5. Insert the catheter 900 into the positioning sheath. The catheter 900 and the positioning sheath are displayed in the three-dimensional system, completing the subsequent surgery.

[0087] Compared with traditional two-dimensional imaging, the above process allows the surgeon to intuitively understand the surgical path in three dimensions, improving surgical efficiency and reducing radiation damage. Compared with electro-positioning three-dimensional display, it eliminates the need for prior modeling and position calibration using magnetic positioning catheters, simplifying the surgical process and providing higher positioning accuracy and better three-dimensional display accuracy.

[0088] In the above embodiments, the descriptions of each embodiment have different focuses. For parts that are not described in detail or recorded in a certain embodiment, please refer to the relevant descriptions of other embodiments.

[0089] It should be noted that the above embodiments can be freely combined as needed. The above are merely preferred embodiments of this application. It should be pointed out that for those skilled in the art, several improvements and modifications can be made without departing from the principles of this application, and these improvements and modifications should also be considered within the scope of protection of this application.

Claims

1. A positioning sheath, characterized in that, include: The sheath body comprises a main body segment, a bending segment, and a distal head segment connected sequentially from the proximal end to the distal end; The magnetic sensor has at least two components, and at least one magnetic sensor is installed at the far end and the near end of the bending section, respectively. An annular electrode, wherein the number of the annular electrodes is at least one, is installed in the bending section; The tail wire socket is installed near the main body section and is electrically connected to the magnetic sensor and the ring electrode.

2. The positioning sheath according to claim 1, characterized in that, The sheath body has a wire cavity that extends axially through the sheath body and is used to accommodate the wires of the magnetic sensor and the annular electrode.

3. The positioning sheath according to claim 2, characterized in that, The number of magnetic sensors is two, including a first magnetic sensor installed at the far end of the bending section and a second magnetic sensor installed at the near end of the bending section; The number of the wire cavity is two, including a first wire cavity and a second wire cavity; The wires of the first magnetic sensor and the wires of the annular electrode pass through the first wire cavity, and the wires of the second magnetic sensor pass through the second wire cavity; Alternatively, the wires of the first magnetic sensor and the second magnetic sensor may pass through the first wire cavity, and the wires of the annular electrode may pass through the second wire cavity.

4. The positioning sheath according to claim 3, characterized in that, The first guide cavity and the second guide cavity are arranged symmetrically along the central axis of the sheath body.

5. The positioning sheath according to claim 3, characterized in that, A pull wire ring is installed at the far end of the bending section. The pull wire ring is located on the proximal side of the first magnetic sensor. At least two pull wires are provided at the proximal end of the pull wire ring, and the pull wires extend to the proximal end of the sheath body. A bend control handle is installed at the proximal end of the sheath body, and the bend control handle is configured to pull the cable.

6. The positioning sheath according to claim 5, characterized in that, The sheath body is provided with a pull wire cavity, which extends through the sheath body axially and is arranged in a one-to-one correspondence with the pull wire to accommodate the pull wire.

7. The positioning sheath according to claim 5, characterized in that, The sheath body includes an inner tube, a braided layer, and an outer tube, with the inner tube, the braided layer, and the outer tube sequentially sleeved from the inside to the outside; A pull ring is fitted onto the inner tube. The first magnetic sensor, the wire cavity, and the pull cavity are fixed to the outer wall of the inner tube. The second magnetic sensor is fixed to the outer wall of the inner tube, the outer wall of the wire cavity, the outer wall of the pull cavity, or the outer wall of the braided layer.

8. The positioning sheath according to claim 7, characterized in that, A hemostatic valve is provided at the proximal end of the sheath body. The hemostatic valve is located inside the bending handle, and a tube is connected to the proximal end of the hemostatic valve. The end of the tube away from the hemostatic valve extends out from inside the bending handle.

9. The positioning sheath according to claim 8, characterized in that, The distal end has at least one side hole, which connects to the inside of the inner tube; and a three-way valve is connected to the end of the tube body away from the hemostatic valve.

10. A sheath positioning system, characterized in that, include: The positioning processing unit, the display unit, and the positioning sheath as described in any one of claims 1-9; The tail wire socket is electrically connected to the positioning processing unit via a cable. The positioning processing unit is configured to acquire the position information of the magnetic sensor and the annular electrode, and transmit the position information to the display unit. The display unit is configured to receive the position information and output image information of the positioning sheath based on the position information.

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