Medical catheter and positioning method thereof and three-dimensional magnetic positioning system

Abstract

The present invention relates to a medical catheter and a positioning method and a three-dimensional magnetic positioning system. The three-dimensional magnetic positioning system includes a positioning device and a medical catheter. The medical catheter includes a catheter body, a first magnetic sensor and a second magnetic sensor. The catheter body includes a head end pipe section, an adjustable bend section and a non-adjustable bend section that are axially connected in sequence. The first and second magnetic sensors are fixedly arranged inside the adjustable bend section. The positioning device includes a positioning processing unit and a display unit; the first and second magnetic sensors are respectively connected to the positioning processing unit for communication; the positioning processing unit obtains the posture information of the first and second magnetic sensors, and obtains the posture information of the head end pipe section based on the posture information of the first and second magnetic sensors; the display unit receives the posture information of the head end pipe section and displays it. The advantage of the present invention is that the position of the head end pipe section can be accurately located, thereby improving the positioning accuracy of the medical catheter and the safety of interventional surgery.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a medical catheter and a positioning method thereof and a three-dimensional magnetic positioning system. Background Art

[0002] Cardiovascular disease is a serious threat to human health, with high morbidity, disability and mortality rates. At present, minimally invasive interventional surgery has become a relatively effective method for clinical diagnosis and treatment of cardiovascular disease. It usually requires the use of various guide sheaths 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 ablation catheters, drugs, etc. to the patient's lesion site, thereby achieving the purpose of diagnosing and locally treating lesions in the human body. The guide sheath is usually composed of a tube body and a handle body. The tube body is long and has an inner cavity used as a channel. The tube body has a distal end and a proximal end. The distal end can easily enter the human body's lumen (such as a blood vessel), and the proximal end is connected to the handle body for professional doctors to operate.

[0003] During the design and manufacturing process of the guide sheath, the distal end will be pre-shaped into different bends according to its intended use, so that it can adapt to the anatomical morphology of the specific lesion site, so as to facilitate the distal end of the guide sheath to align with the lesion site in the human body. In recent years, various shapes and angles of distal pre-shaped guide sheaths have been developed and put into clinical use, which requires hospitals to prepare all specifications and models of guide sheaths, increasing the cost of the hospital. However, when there are individual differences in the physiological and anatomical structure of the human body, even the distal pre-shaped guide sheath designed according to the specific physiological and anatomical structure of the human body cannot adapt to the individual physiological and anatomical structure. During the operation, it is usually necessary to replace the pre-shaped guide sheath of other shapes, which increases the surgical burden on patients. Therefore, in recent years, the technology of adjustable distal bend of the guide sheath has been developed, which allows the distal end of the guide sheath to repeatedly change between different angles through in vitro adjustment to adapt to different physiological and anatomical forms.

[0004] Traditional electrophysiological interventional surgery is performed in a two-dimensional mode. Professional doctors can only establish a channel in the human body under the guidance of an X-ray machine, combining X-ray imaging and operation methods. The operation time is long, the accuracy is low, and the risk is high. Moreover, even doctors with good experience in electrophysiological interventional surgery still need to use X-rays many times to display the shape of the heart and determine the position of the guide sheath, which causes a lot of radiation to patients and doctors. Therefore, at present, the channel for guiding electrophysiological catheters in the human body is still in a two-dimensional mode combined with X-ray imaging, which not only easily exposes both doctors and patients to a high radiation environment, but also has low positioning accuracy, which is not convenient for doctors to accurately grasp the position of the electrophysiological catheter relative to the patient, reducing the accuracy and safety of interventional surgery. On the other hand, in other existing medical catheters, although the position of the catheter has been located and displayed by setting a magnetic positioning sensor to avoid excessive X-ray radiation for patients and doctors, there is a magnetic positioning sensor that is only set on one side of the catheter or the magnetic positioning position is set unreasonably, so that the position of the catheter cannot be accurately displayed. Summary of the invention

[0005] The purpose of the present invention is to provide a medical catheter and a positioning method thereof and a three-dimensional magnetic positioning system, aiming to solve one or more problems existing in the background technology, accurately locate and display the position and direction of the head end tube section of the medical catheter through a magnetic sensor, improve the control accuracy of the medical catheter, improve the accuracy of interventional surgery, and at the same time protect both doctors and patients from radiation as much as possible, thereby improving the safety of interventional surgery.

[0006] To achieve the above-mentioned purpose, according to a first aspect of the present invention, a medical catheter is provided, comprising a catheter body, a first magnetic sensor and a second magnetic sensor; the catheter body comprises a head end pipe section, an adjustable bend section and a non-adjustable bend section which are axially connected in sequence; the first magnetic sensor and the second magnetic sensor are both fixedly arranged inside the adjustable bend section.

[0007] Optionally, the first magnetic sensor and the second magnetic sensor are symmetrically arranged inside the adjustable bending section.

[0008] Optionally, the first magnetic sensor and the second magnetic sensor are arranged in parallel or non-parallel.

[0009] Optionally, the first magnetic sensor and the second magnetic sensor are arranged at an angle, and the angle is 5° to 175°.

[0010] Optionally, the angle is 90°.

[0011] Optionally, the medical catheter further comprises a traction ring and a traction wire, wherein the traction ring is arranged inside the distal end of the adjustable bending section, the traction wire is movably arranged in the catheter body, one end of the traction wire is connected to the traction ring, and the traction wire and the traction ring cooperate to control the bending direction of the adjustable bending section;

[0012] The first magnetic sensor and the second magnetic sensor are arranged between the traction ring and the boundary line between the head end pipe section and the adjustable bending section, or at least a part of the first magnetic sensor and at least a part of the second magnetic sensor are arranged on the traction ring.

[0013] Optionally, the first magnetic sensor and the second magnetic sensor both have relative connecting ends and free ends, and the free end of the first magnetic sensor and / or the free end of the second magnetic sensor is located at the dividing line, or, at a radial section of the catheter body along the dividing line, the free end of the first magnetic sensor and / or the free end of the second magnetic sensor is aligned with the dividing line.

[0014] Optionally, the catheter body includes an inner tube and an outer tube, and the traction ring is sleeved on the inner tube; the medical catheter further includes a mounting component, which is located inside the adjustable bend section and fixedly mounted on the inner tube;

[0015] A first positioning groove and a second positioning groove are provided on the mounting component; a part of the first magnetic sensor is provided in the first positioning groove, and another part is provided on the inner tube, a part of the second magnetic sensor is provided in the second positioning groove, and another part is provided on the inner tube; or, the first magnetic sensor is entirely provided in the first positioning groove, and the second magnetic sensor is entirely provided in the second positioning groove.

[0016] Optionally, the mounting component is made of a developing material, or an outer surface of the mounting component is coated with a developing material.

[0017] Optionally, the mounting component includes a structural member disposed at a distal end of the traction ring.

[0018] Optionally, the structural member includes a first positioning block and a second positioning block, the first positioning block and the second positioning block are both triangular blocks and are symmetrically arranged on the inner layer tube, the first positioning groove is arranged on the first positioning block, and the second positioning groove is arranged on the second positioning block; or, the structural member is a hollow cylindrical body and is sleeved on the inner layer tube, and the first positioning groove and the second positioning groove are both arranged on the outer circumferential surface of the hollow cylindrical body.

[0019] Optionally, the traction ring is used as the mounting component.

[0020] Optionally, the first magnetic sensor and the second magnetic sensor are located on opposite sides of the adjustable bending section, or the first magnetic sensor and the second magnetic sensor are located on the same side of the adjustable bending section and distributed along the axial direction.

[0021] Optionally, the first magnetic sensor and the second magnetic sensor are both five-degree-of-freedom sensors.

[0022] Optionally, the medical catheter is a guide sheath or an electrophysiological catheter.

[0023] When the medical catheter is a guide sheath, it can be used to quickly and conveniently establish a channel in the body and accurately guide the medical catheter to the lesion site.

[0024] To achieve the above objective, according to a second aspect of the present invention, a three-dimensional magnetic positioning system is provided, comprising any one of the medical catheters and the positioning device.

[0025] The positioning device includes a positioning processing unit and a display unit; the first magnetic sensor and the second magnetic sensor are respectively connected to the positioning processing unit for communication;

[0026] The positioning processing unit is configured to obtain the position information of the first magnetic sensor and the position information of the second magnetic sensor, and obtain the position information of the head end pipe section according to the obtained position information of the first magnetic sensor and the position information of the second magnetic sensor;

[0027] The display unit is communicatively connected to the positioning processing unit, and is configured to receive and display the position information of the head end pipe segment.

[0028] Optionally, the first magnetic sensor and the second magnetic sensor are symmetrically arranged inside the adjustable bending section and located on two opposite sides;

[0029] The positioning processing unit is configured to obtain the middle position information of the head end pipe section according to the obtained position information of the first magnetic sensor and the position information of the second magnetic sensor, and simulate an image model through the middle position information of the head end pipe section;

[0030] The image model is used to represent the position and posture of the head end pipe segment, and the image model is displayed through the display unit.

[0031] Optionally, the first magnetic sensor and the second magnetic sensor are both five-degree-of-freedom sensors;

[0032] The positioning processing unit is configured to synthesize the posture information of a six-degree-of-freedom sensor based on the posture information of the two five-degree-of-freedom sensors, and use the posture information of the six-degree-of-freedom sensor to obtain the middle position information of the head-end pipe segment.

[0033] Optionally, the positioning processing unit is further configured to perform graphical processing on the position and posture information of the head end pipe segment; and the display unit is configured to receive and display the graphically processed position and posture information.

[0034] To achieve the above object, according to a third aspect of the present invention, a positioning method for a medical catheter is provided, wherein the medical catheter comprises a catheter body, a first magnetic sensor and a second magnetic sensor, wherein the catheter body comprises a head end pipe section, an adjustable bend section and a non-adjustable bend section which are axially connected in sequence, and the first magnetic sensor and the second magnetic sensor are fixedly arranged inside the adjustable bend section, and the positioning method comprises:

[0035] Acquiring position information of the first magnetic sensor and position information of the second magnetic sensor;

[0036] According to the acquired posture information of the first magnetic sensor and the posture information of the second magnetic sensor, the posture information of the remote end of the head end is acquired and displayed.

[0037] Optionally, the first magnetic sensor and the second magnetic sensor are symmetrically arranged inside the adjustable bend section and located on opposite sides, and the method for acquiring the position information of the head end pipe section includes:

[0038] Acquire the middle position information of the head-end pipe section according to the acquired position information of the first magnetic sensor and the position information of the second magnetic sensor;

[0039] An image model is obtained by simulating the intermediate information of the head-end pipe segment, and the image model is used to represent the position and posture of the head-end pipe segment;

[0040] The image model is displayed.

[0041] Optionally, the first magnetic sensor and the second magnetic sensor are both five-degree-of-freedom sensors, and the step of acquiring the intermediate position information of the head-end pipe section includes:

[0042] The posture information of a six-degree-of-freedom sensor is synthesized according to the posture information of the two five-degree-of-freedom sensors, and the middle position information of the head-end pipe section is acquired by using the posture information of the six-degree-of-freedom sensor.

[0043] The medical catheter and its positioning method and three-dimensional magnetic positioning system provided by the present invention have the following advantages:

[0044] In interventional surgery, through the cooperation of the above-mentioned medical catheter and the positioning device, the position and direction of the head end tube section of the medical catheter in the body can be accurately located, and under the guidance of the image, the operator can accurately control the bending direction of the head end tube section. For example, when the medical catheter is a guide sheath, it can be used to conveniently and quickly establish a channel in the body, accurately guide the medical catheter to the lesion site, and at the same time protect both the doctor and the patient from radiation, thereby improving the accuracy and safety of the interventional surgery. In particular, the two magnetic sensors are arranged between the traction ring and the dividing line between the head end tube section and the adjustable bending section or on the traction ring, so that the two magnetic sensors are arranged adjacent to the head end tube section, which is convenient for more accurate judgment of the position of the head end tube section, and when the bending is controlled, the two magnetic sensors will not be affected by the bending control, reducing the risk of magnetic sensor breakage and ensuring the reliability of magnetic positioning.

[0045] The above-mentioned medical catheter preferably installs two magnetic sensors through a mounting component, which can ensure the installation accuracy of the magnetic sensors on the one hand, and reduce the process difficulty of installing the magnetic sensors on the other hand, thereby reducing the manufacturing cost. In addition, the above-mentioned mounting component is preferably capable of developing, and a traction ring is more preferably used as the mounting component to avoid the introduction of an additional structural member, and the functions of positioning, developing and pulling can be integrated into one, while ensuring the precise positioning of the two magnetic sensors, and playing a role in confirming the positions of the two magnetic sensors before surgery, and avoiding increasing the length of the hard section of the head end tube section, reducing the risk of the hard section of the head end tube section scratching the myocardium or blood vessels during the bending control, and further improving the safety of interventional surgery.

[0046] The two magnetic positioning sensors of the above-mentioned medical catheter are preferably arranged on the traction ring. Since the traction ring is located closest to the head end pipe section, the middle position information of the head end pipe section obtained according to the posture information of the two magnetic positioning sensors on the traction ring can more accurately judge the position of the head end pipe section, thereby further improving the control accuracy of the medical catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0047] Those skilled in the art will appreciate that the accompanying drawings are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention.

[0048] Figure 1 This is an application scenario diagram of a three-dimensional magnetic positioning system in a preferred embodiment of the present invention;

[0049] Figure 2 is a schematic diagram of the structure of the guide sheath in a preferred embodiment of the present invention, wherein the adjustable bending section is shown in an unbent state, a bent state to one side, and a bent state to the other side;

[0050] Figure 3 is a schematic structural diagram of a guide sheath tube in a preferred embodiment of the present invention, wherein the adjustable bending section is in an unbent state;

[0051] Figure 4 is along Figure 3 A cross-sectional view of the guide sheath obtained by cutting along the line AA;

[0052] Figure 5 yes Figure 4 A partial enlarged view of the guide sheath at position I is shown, wherein for the purpose of explanation, a partial enlarged view of two magnetic sensors placed inside the adjustable bend is additionally shown using leads B1 and B2, so as to more clearly show the structures at these positions;

[0053] Figure 6 is a rotation coordinate diagram of a six-degree-of-freedom sensor in an embodiment of the present invention;

[0054] Figure 7 is a schematic structural diagram of the guide sheath tube in the first embodiment of the present invention;

[0055] Figure 8 is along Figure 7 The cross-sectional view of the guide sheath is obtained by cutting along the line BB;

[0056] Fig. 9 is a three-dimensional schematic diagram of the placement of the magnetic sensor on the guide sheath in the first embodiment of the present invention, that is, Figure 8 A partial enlarged view of the guide sheath at position II is shown;

[0057] Fig.10 yes Fig. 9 A top view of the magnetic sensor shown being placed on the guide sheath;

[0058] Fig.11 is along Fig.10 The cross-sectional view obtained by cutting the CC line of the guide sheath shown;

[0059] Fig.12 is a three-dimensional schematic diagram of the placement position of the magnetic sensor on the guide sheath in the second embodiment of the present invention;

[0060] Fig.13 yes Fig.12 A top view of the magnetic sensor shown being placed on the guide sheath;

[0061] Fig.14 is along Fig.13 The cross-sectional view obtained by cutting the guide sheath along the DD line shown;

[0062] Fig.15 is a three-dimensional schematic diagram of the placement position of the magnetic sensor on the guide sheath in the third embodiment of the present invention;

[0063] Fig.16 yes Fig.15A top view of the magnetic sensor shown being placed on the guide sheath;

[0064] Fig.17 is along Fig.16 The cross-sectional view obtained by cutting the guide sheath along the EE line shown;

[0065] Fig.18 is a schematic structural diagram of the guide sheath tube in the fourth embodiment of the present invention;

[0066] Fig.19 is along Fig.18 The cross-sectional view of the guide sheath is obtained by cutting along the line FF;

[0067] Fig. 20 yes Fig.19 A partial enlarged view of the guide sheath at position III is shown, wherein for the purpose of explanation, a partial enlarged view of two magnetic sensors placed on the positioning block is additionally shown using leads C1 and C2, so as to more clearly show the structures at these positions;

[0068] Fig.21 is a three-dimensional schematic diagram of the placement position of the magnetic sensor on the guide sheath in the fifth embodiment of the present invention;

[0069] Fig. 22 yes Fig.21 A top view of the magnetic sensor shown being placed on the guide sheath;

[0070] Fig.23 is along Fig. 22 A cross-sectional view of the guide sheath tube shown is obtained by cutting along the HH line;

[0071] The following are the descriptions of the reference numerals:

[0072] Guide sheath-10; head end tube section-11; adjustable bend section-12; handle body-13; side branch-14; non-adjustable bend section-15; magnetic positioning structure-16; first magnetic sensor-161; second magnetic sensor-162; connecting tail line-17; traction ring-18; traction wire-191; inner tube-192; electrophysiological catheter-20; positioning device-30; positioning processing unit-31; display unit-32; equipment connector-33; structural parts-41, 42, 43, 44; first positioning block-411; second positioning block-412; first dividing line-S1; second dividing line-S2. DETAILED DESCRIPTION

[0073] The core idea of ​​the present invention is to provide a three-dimensional magnetic positioning system, including a positioning device and a medical catheter. The positioning device includes a positioning processing unit and a display unit.

[0074] The medical catheter comprises a catheter body, a first magnetic sensor and a second magnetic sensor. The catheter body comprises a head end pipe section, an adjustable bend section and a non-adjustable bend section which are connected in sequence axially. The first magnetic sensor and the second magnetic sensor are both fixedly arranged inside the adjustable bend section.

[0075] The first magnetic sensor and the second magnetic sensor are respectively connected to the positioning processing unit for communication. The positioning processing unit is configured to obtain the posture information of the first magnetic sensor and the posture information of the second magnetic sensor. The positioning processing unit is also configured to obtain the posture information of the head-end pipe segment according to the posture information of the first magnetic sensor and the posture information of the second magnetic sensor. The display unit is connected to the positioning processing unit for communication, and is configured to receive and display the posture information of the head-end pipe segment. Further, the positioning processing unit can perform graphical processing on the posture information of the head-end pipe segment, and the display unit receives and displays the graphically processed posture information. The present invention does not limit the manner in which the positioning processing unit performs graphical processing on the posture information of the head-end pipe segment. For example, the graphical processing method may include using vector lines to represent the posture information of the head-end pipe segment, or using a graphic similar to or identical to the shape of the head-end pipe segment to represent the posture information of the head-end pipe segment. It should be known that the posture information includes spatial position information and direction information. In addition, the medical catheter may be a guide sheath or an electrophysiological catheter, and the electrophysiological catheter may be a radiofrequency ablation catheter or a mapping catheter.

[0076] With such configuration, when performing interventional surgery, the position and direction of the head end tube section of the medical catheter in the cavity can be tracked in real time by two magnetic sensors, and the position and direction of the head end tube section can be displayed in real time by the display unit. In this way, the control accuracy of the medical catheter is improved. For example, when the medical catheter is a guide sheath, it is convenient to quickly establish a channel in the body and accurately guide the medical catheter to the lesion site. At the same time, it can also protect both the doctor and the patient from radiation, thereby improving the accuracy and safety of the interventional surgery. In particular, considering that the magnetic sensor is relatively fragile, in order to avoid the problem of its breakage during use, the two magnetic sensors are arranged between the traction ring and the dividing line between the head end tube section and the adjustable bend section or on the traction ring, that is, the present invention arranges the two magnetic sensors adjacent to the head end tube section, which is convenient for more accurate judgment of the position of the head end tube section and improves the catheter positioning accuracy, but does not increase the hardness of the head end tube section. Moreover, when the adjustable bend section is controlled to bend, the two magnetic sensors will not be affected by the control of the bend, thereby reducing the risk of the magnetic sensor breakage and ensuring the reliability of magnetic positioning.

[0077] To make the purpose, advantages and features of the present invention clearer, the present invention is further described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the accompanying drawings are all in a very simplified form and are not drawn to scale, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention. In addition, the structure shown in the accompanying drawings is often a part of the actual structure. In particular, the emphasis of each accompanying drawing is different, and sometimes different proportions are used. As used in this specification, the singular forms "one", "an" and "the" include plural objects, unless the content clearly indicates otherwise. As used in this specification, the term "or" is usually used in the sense of including "and / or", unless the content clearly indicates otherwise, the term "proximal end" is usually the end close to the operator, and the term "distal end" is usually the end close to the patient (i.e., close to the lesion).

[0078] In the following description, a medical catheter is used as a guide sheath as an illustration to further illustrate the structure and usage of the three-dimensional magnetic positioning system of the present invention, but the medical catheter of the present invention can also be a radiofrequency ablation catheter or a mapping catheter.

[0079] like Figure 1 As shown, this embodiment relates to a three-dimensional magnetic positioning system, which includes a guide sheath 10, an electrophysiological catheter 20 and a positioning device 30. The positioning device 30 includes a positioning processing unit 31 and a display unit 32. The electrophysiological catheter 20 can be a mapping catheter or a radiofrequency ablation catheter. The guide sheath 10 includes a catheter body and a control handle connected to each other, and the catheter body includes a proximal part and a distal part.

[0080] like Figure 2 As shown, the distal part includes a head end pipe section 11 and an adjustable bend section 12 connected thereto. The head end pipe section 11 is located at the distal end of the adjustable bend section 12, and its material is usually a soft polymer material, and its function is to avoid scratching the blood vessels or myocardium in the blood vessels or the heart. Usually, at least one exhaust hole is provided on the side wall of the head end pipe section 11, which is helpful for suction operation and reduces cavities and bubbles. The proximal part includes a non-adjustable bend section 15, and the proximal end of the adjustable bend section 12 is connected to the non-adjustable bend section 15. The control handle includes a handle body 13 and a side branch 14. The side branch 14 provides an input and output interface, which can be used for surgical operations such as suction, fluid infusion, blood sampling, and pressure monitoring. This is a prior art and will not be described in detail. The proximal end of the non-adjustable bend section 15 is connected to the handle body 13. Furthermore, in order to more clearly understand the boundary position between the adjustable bend section 12 and the non-adjustable bend section 15, for example, Figures 2 to 4Or other figures mark the boundary position of the adjustable bend section 12 and the non-adjustable bend section 15, and indicate it with a first dividing line S1. The position far from the first dividing line S1 is the adjustable bend section 12, and the position close to the first dividing line S1 is the non-adjustable bend section 15. The boundary position of the head end pipe section 11 and the adjustable bend section 12 is also marked, and indicated by a second dividing line S2. It should be understood that the material hardness of the head end pipe section 11, the adjustable bend section 12 and the non-adjustable bend section 15 is different, the material of the head end pipe section 11 is softer, and the material hardness of the adjustable bend section 12 is lower than the material hardness of the non-adjustable bend section 15 and higher than the material hardness of the head end pipe section 11, so that the adjustable bend section 12 is easy to bend under pulling, while the non-adjustable bend section 15 (or straight pipe section) is not bendable.

[0081] like Figures 3 to 5 As shown, the guide sheath 10 also includes a magnetic positioning structure 16 for locating the position and direction (i.e., posture) of the head end pipe section 11. The magnetic positioning structure 16 is arranged inside the adjustable bend section 12 and away from the first dividing line S1. Preferably, the magnetic positioning structure 16 is arranged between the traction ring 18 and the second dividing line S2 or on the traction ring 18. The advantage is that the magnetic positioning structure 16 is arranged adjacent to the head end pipe section 11, which facilitates more accurate positioning of the head end pipe section 11, and when the adjustable bend section 12 is controlled to bend, the magnetic positioning structure 16 (including two magnetic sensors) will not be affected by the control bending, which reduces the risk of the magnetic sensor breaking and ensures the reliability of the magnetic positioning.

[0082] The magnetic positioning structure 16 specifically includes a first magnetic sensor 161 and a second magnetic sensor 162, both of which are fixedly arranged inside the adjustable bend section 13, and are preferably arranged adjacent to the head end pipe section 11. In this embodiment, each magnetic sensor has a relative connection end A and a free end B, wherein one end of each magnetic sensor connection wire is the connection end A, and the other end is the free end B. Preferably, the free end B of at least one of the two magnetic sensors is located at the second dividing line S2, or, at the radial section of the catheter body along the second dividing line S2, the free end B of at least one of the two magnetic sensors is aligned with the second dividing line S2. For example, in some embodiments, the two magnetic sensors are distributed in the circumference of the adjustable bend section 12 and are located on opposite sides of the adjustable bend section 12. At this time, the free ends B of the two magnetic sensors are preferably located at the second dividing line S2 or aligned with the second dividing line S2. In other embodiments, the two magnetic sensors are distributed in the axial direction of the adjustable bend section 12 and are located on the same side inside the adjustable bend section 12, that is, the two magnetic sensors are on a straight line on a circular surface parallel to the central axis of the catheter body. At this time, the free end B of one of the magnetic sensors is preferably located at the second dividing line S2 or aligned with the second dividing line S2.

[0083] In addition, the two magnetic sensors are arranged at an angle on the catheter body, and the angle is 0° to 180° (including 0° and 180°). Preferably, the angle is 5° to 175°, and more preferably, the angle is 90°. It should be understood that the angle between the two magnetic sensors refers to the angle between the two rays, that is, the angle between the two AB direction rays on the two magnetic sensors is the angle between the two magnetic sensors. Preferably, the first magnetic sensor 161 and the second magnetic sensor 162 are symmetrically arranged inside the adjustable bend 12. The two symmetrically arranged magnetic sensors help to improve the positioning accuracy, and can also simplify the calculation workload of the positioning processing unit 31 and improve the processing efficiency. Further, the first magnetic sensor 161 and the second magnetic sensor 162 can be arranged in parallel or not in parallel. In addition, the first magnetic sensor 161 and the second magnetic sensor 162 are both connected to the positioning processing unit 31 for communication, for example, through the connecting tail line 17 to communicate with the positioning processing unit 31. Optionally, the connecting tail line 17 is connected to the device connector 33 of the positioning processing unit 31. The display unit 32 is in communication connection with the positioning processing unit 31 .

[0084] In actual use, the positioning processing unit 31 is used to obtain the posture information of the first magnetic sensor 161 and the posture information of the second magnetic sensor 162, and then, based on the obtained posture information of the first magnetic sensor 161 and the posture information of the second magnetic sensor 162, the posture information of the head-end pipe segment 11 is obtained. Furthermore, the display unit 32 receives the posture information of the head-end pipe segment 11 and displays it. Further, the first magnetic sensor 161 and the second magnetic sensor 162 are symmetrically arranged inside the adjustable bending section 12 and located on opposite sides. Preferably, the positioning processing unit 31 is configured to obtain the intermediate position information of the head end pipe section 11 (i.e., the position of the central axis of the catheter body) according to the acquired position information of the first magnetic sensor 161 and the second magnetic sensor 162, and simulate an image model through the intermediate position information of the head end pipe section 11. The image model can be a straight line (such as a length of 5mm to 6mm), or the image model is a three-dimensional model similar in shape and / or size to the head end pipe section 11, and the image model is displayed by the display unit 32. With this structure, the head end pipe section 11 can be simplified by the image model, and the image model is displayed by the display unit 32. Therefore, when controlling the bending, the operator can more accurately judge the position and direction of the head end pipe section 11 according to the display of the image.

[0085] The first magnetic sensor 161 and the second magnetic sensor 162 are preferably five-degree-of-freedom sensors, and two five-degree-of-freedom sensors are used to synthesize a six-degree-of-freedom sensor, which is equivalent to tracking the position and direction of the head-end pipe segment 11 through a six-degree-of-freedom sensor, and the positioning effect is good. Further, the positioning processing unit 31 uses the posture information of the six-degree-of-freedom sensor to obtain the intermediate position information of the head-end pipe segment 11. Further, the positioning processing unit 31 can directly use the uncorrected posture information of the six-degree-of-freedom sensor as the intermediate position information of the head-end pipe segment 11, and the positioning processing unit 31 can also use the corrected posture information of the six-degree-of-freedom sensor as the intermediate position information of the head-end pipe segment 11. In the present invention, how to use two five-degree-of-freedom sensors to synthesize a six-degree-of-freedom sensor is a prior art, and therefore, the present invention does not describe this synthesis method in detail. The present invention uses two five-degree-of-freedom sensors to track the position and direction of the head end tube segment 11. Compared with directly using a six-degree-of-freedom sensor, the cost is lower and the space occupied is also small. It not only reduces the size of the guide sheath (or other medical catheter), but also reduces the manufacturing cost of the guide sheath (or other medical catheter). At the same time, the two magnetic sensors are arranged on opposite sides of the catheter body, which can more accurately determine the position of the guide sheath 10 (or other medical catheter). It should be understood that the synthesized six-degree-of-freedom sensor can rotate and move freely in space, and the position, rotation and movement of the six-degree-of-freedom sensor correspond to the position, rotation and movement of the head end tube segment 11. In this way, the position and direction of the head end tube segment 11 can be accurately determined by the six-degree-of-freedom sensor, which facilitates the operator to accurately control the bending direction of the adjustable curved section 12 according to the position and direction of the six-degree-of-freedom sensor, thereby improving the control accuracy of the guide sheath 10 (or other medical catheter), facilitating the rapid establishment of a channel in the body, and enabling the electrophysiological catheter 20 to be more accurately positioned to the lesion during ablation or mapping.

[0086] In more detail, the direction information of the head end pipe section 11 is mainly to obtain the angle information of the head end pipe section 11, that is, the angle information of the six-degree-of-freedom sensor. Generally, it can be represented by a rotation matrix, a rotation vector, a quaternion or an Euler angle, and these quantities can also be converted to each other, among which the Euler angle is more widely used. In some embodiments, the direction information of the head end pipe section 11 can be represented by a rotation matrix. Taking the rectangular coordinate system xyz as an example, it is known that the quaternion q = (θ xyz) T ; where θ is the axis angle; (xyz) is a vector; x is the coordinate value of the x-axis; y is the coordinate value of the y-axis; z is the coordinate value of the z-axis. When the unit vector ω=(xyz) is rotated by an angle of θ, the rotation matrix R can be obtained based on the quaternion:

[0087]

[0088] The above rotation matrix R can also be expressed in Euler angles, that is, a series of rotations around the axes of a coordinate system, describing in space how a fixed, known reference system is obtained through a series of basic rotations to obtain another new reference system. Figure 6 As shown, the coordinate axes of the original reference system xyz are defined as x, y, and z, and the coordinate axes of the new reference system XYZ after rotation are defined as X, Y, and Z; N is called the intersection line, which is a line where the xy and XY coordinate planes intersect.

[0089] When the posture of the head end pipe section 11 is represented by Euler angles, it is first described by the following matrix:

[0090]

[0091] Formula (1-1) is equivalent to

[0092] Where: r 11 =cosθ+x 2 (1-cosθ); r 12 = -zsinθ+xy(1-cosθ);

[0093] r 13 =ysinθ+xz(1-cosθ); r 21 =zsinθ+xy(1-cosθ); r 22 =cosθ+y 2 (1-cosθ);

[0094] r 23 = -xsinθ+yz(1-cosθ); r 31 = -ysinθ+xz(1-cosθ); r 32 =xsinθ+yz(1-cosθ);

[0095] r 33 =cosθ+z 2 (1-cosθ). α is the angle between the x-axis and the N-axis, representing the rotation around the z-axis; β is the angle between the z-axis and the Z-axis, representing the rotation around the N-axis; γ is the angle between the N-axis and the x-axis, representing the rotation around the z-axis.

[0096] Then, the corresponding Euler angle can be obtained through the rotation matrix R:

[0097] θ x =atan2(r 32 , r 33 )

[0098]

[0099] θz =atan2(r 21 , r 11 )

[0100] Where: θ x ,θ y and θ z are the rotation angles around the x-axis, y-axis and z-axis respectively. The posture of the six-degree-of-freedom sensor can be determined through the Euler angle, that is, the posture of the head end pipe section 11 is determined.

[0101] Those skilled in the art should understand that when the relative position of the two magnetic sensors remains fixed and has a certain angle, the spatial position of each magnetic sensor can be determined. For example, a magnetic field generator is set outside the magnetic sensor, and the magnetic sensor is affected by the magnetic field to generate an induced current, which is fed back to the positioning processing unit 31 through the connecting tail line 17. The positioning processing unit 31 processes the position of the magnetic sensor in the magnetic field and finally determines the specific position of the magnetic sensor in space. When the two magnetic sensors are relatively fixed and the angle is fixed, when the guide sheath 10 rotates, the spatial position of the head end pipe segment 11 can be obtained according to the spatial coordinates of the two magnetic sensors, thereby achieving the purpose of real-time tracking of the head end pipe segment 11.

[0102] In this embodiment, the catheter body preferably includes an inner tube 192 (see Figures 9 to 23 ) and an outer tube (not shown) wrapped outside the inner tube 192, that is, the catheter body is a double-tube structure. In addition, two magnetic sensors are arranged between the inner tube 192 and the outer tube. For example, the two magnetic sensors are fixedly arranged on the inner tube 192, or fixedly arranged on the outer tube. In this embodiment, it is preferred that the two magnetic sensors are fixedly arranged on the inner tube 192, which is not only convenient for installation, but also can reduce the influence on the magnetic sensors when forming the outer tube, ensure that the magnetic sensors will not be displaced, and ensure the positioning accuracy of the magnetic sensors.

[0103] See also Figure 5, the guide sheath 10 also includes a traction ring 18 and a traction wire 191. The traction ring 18 is arranged inside the adjustable bend section 12 and is sleeved on the inner tube 192, and the traction ring 18 is arranged adjacent to the head end tube section 11, that is, the traction ring 18 is arranged adjacent to the second dividing line S2. Preferably, the magnetic positioning structure 16 is arranged on the traction ring 18 so that the magnetic positioning structure 16 is arranged adjacent to the head end tube section 11. Since the position of the traction ring 18 is closer to the head end tube section 11, two magnetic positioning sensors are arranged on the traction ring 18, which can accurately locate the position of the head end tube section 11, improve the control accuracy of the guide sheath 10, and no additional structural parts are required to install the magnetic positioning structure 16, thereby avoiding increasing the hardness and length of the adjustable bend section 12. In other embodiments, the magnetic positioning structure 16 may not be arranged together with the traction ring 18, but the magnetic positioning structure 16 may be installed by an additional structural member, and the structural member is fixedly arranged on the inner tube 192 and located at the distal end of the traction ring 18. Preferably, the structural member is in close contact with the traction ring 18. In addition, the traction wire 191 is inserted into the catheter body, and one end is connected to the traction ring 18, and the other end is connected to the handle body 13. The traction wire 191 can move in the catheter body, and the bending angle of the adjustable bend section 12 can be changed by the movement of the traction wire 191, that is, the bending direction of the adjustable bend section 12 is controlled by the cooperation of the traction ring 18 and the traction wire 191.

[0104] As mentioned above, the two magnetic sensors may be arranged in parallel or in a non-parallel manner. Figure 5 As shown, the first magnetic sensor 161 and the second magnetic sensor 162 are symmetrically fixedly arranged on the inner tube 192, and are located on opposite sides of the inner tube 192 along the circumferential direction. At the same time, the two magnetic sensors are not only arranged in parallel, but also parallel to the central axis of the guide sheath 10. At this time, the angle between the two magnetic sensors is 0°, and the middle position information of the head end tube segment 11 can be obtained based on this, and then the image model is obtained and displayed on the display unit 32. In other embodiments, when the two magnetic sensors are located on opposite sides of the inner tube 192, the two may also be arranged non-parallel. In these methods, the middle position information of the head end tube segment 11 can be obtained by two magnetic sensors on different sides and preferably symmetrically arranged, so that the image model used to represent the middle position of the head end tube segment 11 is displayed on the display unit 32, which is convenient for the operator to more accurately judge the position of the guide sheath 10 and improve the control accuracy of the guide sheath 10.

[0105] Furthermore, in order to ensure the installation accuracy of the magnetic sensor, reduce the process difficulty of installing the magnetic sensor, and reduce the manufacturing cost, the guide sheath 10 also includes a mounting component, which is fixedly arranged on the inner tube 192, specifically arranged on the inner tube 192 of the adjustable bend section 12, and is used to install two magnetic sensors. Among them, at least part of the first magnetic sensor 161 and at least part of the second magnetic sensor 162 are arranged on the mounting component. That is, it can be that a part of each magnetic sensor is arranged on the mounting component, and the other part is arranged on the inner tube 192, or each magnetic sensor is entirely arranged on the mounting component. In this embodiment, a first positioning groove and a second positioning groove are provided on the mounting component, and the first positioning groove is used to place the first magnetic sensor, and the second positioning groove is used to place the second magnetic sensor. For example, in some embodiments, a portion of the first magnetic sensor 161 is disposed in the first positioning groove, and another portion is disposed on the inner tube 192; a portion of the second magnetic sensor 162 is disposed in the second positioning groove, and another portion is disposed on the inner tube 192. This design can reduce the length and hardness of the mounting components and reduce the impact on the bending performance of the adjustable bending section 12. In other embodiments, the first magnetic sensor 161 is entirely disposed in the first positioning groove, and the second magnetic sensor 162 is entirely disposed in the second positioning groove. The provision of the positioning groove facilitates the installation of the magnetic sensor in a narrow space, and also facilitates the setting of the angle between the two magnetic sensors and the precise positioning of the magnetic sensor by the slotting direction of the positioning groove.

[0106] In this embodiment, the installation component may include a structural member, which is fixedly arranged on the inner tube 192 and located at the distal end of the traction ring 18, and the first positioning groove and the second positioning groove are arranged on the structural member. That is, two magnetic sensors are installed by introducing an additional structural member to ensure the positioning accuracy of the magnetic sensors. Preferably, in another embodiment, the traction ring 18 is used as the installation component, so that the first positioning groove and the second positioning groove are arranged on the traction ring 18. Through this design, the introduction of an additional structural member is avoided, and the hardness of the adjustable bend section 12 is also avoided to be increased, and the structure is simpler and the safety is better.

[0107] Further preferably, the mounting component is configured to be able to be developed, that is, the developing component and the mounting component are integrated together. Through this design, before the operation or at the beginning of positioning using the magnetic sensor, the operator can verify the position of the magnetic sensor by developing the mounting component under X-rays, and use the advantages of both to ensure the positioning accuracy of the head end tube segment 11. In addition, there is no need to set an additional developing component (such as a developing ring or a ring electrode) on the head end tube segment 11, thereby shortening the length of the hard segment of the head end tube segment 11, reducing the risk of the hard segment of the head end tube segment 11 scratching the myocardium or blood vessels when performing bending control, and further improving the safety of interventional surgery. Furthermore, the mounting component can be a ring electrode with developing properties.

[0108] In particular, when the traction ring 18 is used as the installation component, the functions of positioning, developing and pulling can be integrated into one, and while ensuring the accurate positioning of the first magnetic sensor 161 and the second magnetic sensor 162, it also plays a role in confirming the position of the first magnetic sensor 161 and the second magnetic sensor 162 before the operation, and avoids increasing the length of the hard section of the head end tube section 11, and avoids increasing the hardness of the adjustable curved section 12. It should be known that during the operation, the position of the head end tube section 11 can be tracked by the developing performance of the installation component, or by two magnetic sensors. The surgeon can use either method, especially when there is no three-dimensional imaging condition during the operation, the developing performance of the installation component can be used to track the head end tube section 11, or when there is no X-ray imaging condition during the operation, the two magnetic sensors can be used to track the head end tube section 11. Such a design makes the use of the guide sheath 10 more flexible and convenient, and can better meet various usage requirements.

[0109] The present invention does not limit the method of preparing the mounting component to be developable, and the mounting component can be prepared by using a developing material, or the developing material can be coated on the outer surface of the mounting component. For example, for the traction ring 18, it is preferred to coat the surface of the traction ring 18 with a developing material to make it developable, so as to avoid the traction ring 18 being easily deformed by tension when the traction ring 18 is made of the developing material as a whole. For example, for a structural part, it is preferred to prepare the structural part with a developing material to make it developable.

[0110] Next, the installation method of the magnetic sensor on the catheter body is further described in more detail in combination with several preferred embodiments. However, it should be understood that the following installation method is not intended to limit the present invention.

[0111] Embodiment 1

[0112] Figure 7 is a schematic structural diagram of the guide sheath tube in the first embodiment of the present invention, Figure 8 is along Figure 7 The cross-sectional view of the guide sheath is obtained by cutting along the BB line. Fig. 9 is a three-dimensional schematic diagram of the placement position of the magnetic sensor in the first embodiment of the present invention, Fig.10 yes Fig. 9 A top view of the structure shown, Fig.11 is along Fig.10 The cross-sectional view shown is taken along the CC line. It should be understood that Figures 9 to 11 The structure shown is Figure 8 The structure of the middle guide sheath 10 at position II.

[0113] like Figures 7 to 11 As shown, the installation component includes a structural member 41, which is composed of two positioning blocks, namely a first positioning block 411 and a second positioning block 412. The structural member 41 is arranged on the traction ring 18 (refer to Figure 5 ) and is preferably arranged close to the traction ring 18. Among them, the two positioning blocks are both arranged on the inner tube 192 and located on the opposite sides of the inner tube 192. Preferably, the two positioning blocks are symmetrically arranged on the inner tube 192. And the two positioning blocks are triangular blocks, that is, as Fig.11 As shown, in the axial section, the two positioning blocks each have a right-angled side (unnumbered), the right-angled side is fitted with the outer surface of the inner tube 192, and the two positioning blocks also have a hypotenuse (unnumbered) that is at an angle to the right-angled side, and a positioning groove is provided on the hypotenuse, and the bottom surface of the positioning groove is parallel to the corresponding hypotenuse. Among them, the first magnetic sensor 161 is entirely arranged in the first positioning groove of the first positioning block 411, and the second magnetic sensor 162 is entirely arranged in the second positioning groove of the second positioning block 412. Since the positioning grooves on the two positioning blocks form an angle α, the angle between the two magnetic sensors is also α, and α is preferably 5° to 175°, and more preferably 90°. In addition, in clinical applications, a variety of guide sheaths 10 with different angles α can be configured to meet different positioning requirements. In addition, the two magnetic sensors are preferably arranged symmetrically, and can be arranged in parallel or non-parallel.

[0114] In this embodiment, by setting the mounting components into two triangular blocks and setting them on opposite sides of the inner tube 192, it is helpful to reduce the hardness of the adjustable bend section 12 and reduce the impact on the bending performance of the adjustable bend section 12. In addition, the material of the structural member 41 can be a developing material or a non-developing material. If the structural member 41 is a non-developing material, a developing component, such as a developing ring or a ring electrode, is set on the side of the structural member 41 away from the traction ring 18. The developing component is set at the distal end of the adjustable bend section 12, mainly at the second dividing line S2, or between the second dividing line S2 and the structural member. If the structural member 41 is a developing material, the developing component set on one side of the structural member 41 can be cancelled, thereby effectively shortening the length of the hardness of the head end pipe section 11, reducing the risk of the hard section of the head end pipe section 11 scratching the blood vessel or the myocardium during the bending adjustment, and improving the safety of the interventional surgery. Moreover, by developing the structural member 41, not only can material costs be saved, but also the position of the magnetic sensor can be calibrated by developing the structural member 41 under X-rays before surgery, thereby utilizing the advantages of both to ensure the positioning accuracy of the head end pipe section 11.

[0115] Embodiment 2

[0116] Fig.12 is a three-dimensional schematic diagram of the placement position of the magnetic sensor in the second embodiment of the present invention, Fig.13 yes Fig.12 A top view of the structure shown, Fig.14 is along Fig.13 The cross-sectional view is taken along the DD line.

[0117] like Figure 12 to Figure 14 As shown, the mounting component includes a structural member 42. Different from the first embodiment, the structural member 42 is a hollow cylinder and is sleeved on the inner tube 192, and a first positioning groove and a second positioning groove are provided on the outer circumferential surface of the cylinder, and the two positioning grooves are on opposite sides of the inner tube 192. Among them, a part of the first magnetic sensor 161 is provided in the first positioning groove, and the other part is directly provided on the inner tube 192. A part of the second magnetic sensor 162 is provided in the second positioning groove, and the other part is directly provided on the inner tube 192. Therefore, the two magnetic sensors are obliquely provided on the inner tube 192, and the angle between the two is α, and α is preferably 5° to 175°. Similarly, if the angle α needs to be changed, it is only necessary to adjust the slotting direction of the positioning groove and the position of the other part of the magnetic sensor on the inner tube 192.

[0118] In this embodiment, the material of the structural member 42 is a non-developing material. In this case, a developing component (not shown) is additionally provided on the side of the structural member 42 away from the traction ring 18. The developing component may be a developing ring or a ring electrode. Alternatively, the material of the structural member 42 may also be a developing material. When the structural member 42 is developable, the developing component provided on one side of the structural member 42 may be eliminated, thereby effectively shortening the length of the hardness of the head end pipe segment 11, reducing the risk of the hard segment of the head end pipe segment 11 scratching the blood vessels or myocardium during bending, and improving the safety of interventional surgery. Moreover, through the development of the structural member 42, not only can the material cost be saved, but also the position of the magnetic sensor can be calibrated by developing the structural member 42 under X-rays before the operation, and the advantages of both can be used to ensure the positioning accuracy of the head end pipe segment 11.

[0119] Compared with the design scheme in the first embodiment, the design scheme in the second embodiment can further shorten the axial length of the structural member and reduce the length and hardness of the adjustable bending section 12 .

[0120] Embodiment 3

[0121] Fig.15 is a three-dimensional schematic diagram of the placement position of the magnetic sensor in the third embodiment of the present invention, Fig.16 yes Fig.15 A top view of the structure shown, Fig.17 is along Fig.16 The cross-sectional view of the EE line shown in FIG. Figures 15 to 17 The traction ring 18 is not shown at all.

[0122] like Figures 15 to 17 As shown, the mounting component includes a structural member 43. Different from the first embodiment, the structural member 43 is a hollow cone and is sleeved on the inner tube 192, and a first positioning groove and a second positioning groove are arranged on the outer circumference of the cone, and the two positioning grooves are arranged on opposite sides of the inner tube 192. The bottom surface of each positioning groove is parallel to the inclined surface of the cone. Among them, the first magnetic sensor 161 is entirely arranged in the first positioning groove, and the second magnetic sensor 162 is entirely arranged in the second positioning groove. Since the two positioning grooves form an angle α, the angle between the two magnetic sensors is also α, and α is preferably 5° to 175°. Similarly, in this embodiment, the material of the structural member 43 can be a non-developing material, and a developing component (not shown) is arranged on the side of the structural member 43 away from the traction ring 18. The developing component can be a developing ring or a ring electrode. Alternatively, the material of the structural member 43 can also be a developing material. When the structural member 43 can be developed, the developing component arranged on one side of the structural member 43 can be cancelled. The advantages are the same as those of the second embodiment and will not be repeated.

[0123] Embodiment 4

[0124] Fig.18 19 is a structural diagram of the guide sheath tube in the fourth embodiment of the present invention, Fig.18 The axial cross-section of the guide sheath tube is obtained by cutting along the FF line. Fig. 20 yes Fig.19 For the purpose of explanation, Fig. 20 An additional partial enlarged view of the placement of two magnetic sensors on the positioning block is shown using leads C1 and C2 to more clearly show the structure of these locations.

[0125] like Figures 18 to 20 As shown, the mounting component includes a structural member 41 of the same structure as that in the first embodiment. Different from the first embodiment, the first magnetic sensor 161 and the second magnetic sensor 162 are located on the same side of the inner tube 192 and are distributed axially along the catheter body. In this case, the two positioning blocks (411 and 412) can be symmetrically arranged or asymmetrically arranged. Furthermore, the two magnetic sensors can be symmetrically arranged or asymmetrically arranged, and the two magnetic sensors can be parallel or non-parallel. Preferably, the two magnetic sensors are on a straight line on a circumferential surface parallel to the central axis of the catheter body. In addition, the two magnetic sensors can be as follows Fig. 20 The adjacent arrangement shown may also be a non-adjacent arrangement.

[0126] Compared with the design solutions in the above embodiments, the design solution in the fourth embodiment can obtain the position information of one side of the head end pipe section 11 through the posture information of the two magnetic sensors.

[0127] Embodiment 5

[0128] Fig.21 is a three-dimensional schematic diagram of the placement position of the magnetic sensor in the fifth embodiment of the present invention, Fig. 22 yes Fig.21 A top view of the structure shown, Fig.23 is along Fig. 22 The cross-sectional view is taken along the line HH.

[0129] like Figure 21 to Figure 23 As shown, the mounting component includes a traction ring 18, and the magnetic sensor is mounted through the traction ring 18. The traction ring 18 is a hollow cylinder, and its diameter is larger than the outer diameter of the inner tube 192 of the catheter body. Therefore, two positioning grooves are provided on the traction ring 18, and a part of the two magnetic sensors is respectively arranged in the corresponding positioning grooves, and the other part is arranged on the inner tube 192. Preferably, the traction ring 18 is sprayed with a developing material for development.

[0130] Compared with embodiments one, two and three, the hard section of the head end pipe section 11 can be further shortened through the development of the traction ring 18, and the hardness of the adjustable bend section 12 will not be increased, which is better than setting a developable structural part at the far end of the traction ring 18, and better than setting a developing component on one side of the structural part.

[0131] Embodiment 6

[0132] This embodiment provides a positioning method for a medical catheter, wherein the medical catheter may be a guide sheath or an electrophysiological catheter, and the positioning method includes:

[0133] Acquire the position information of the first magnetic sensor 161 and the position information of the second magnetic sensor 162;

[0134] Based on the acquired posture information of the first magnetic sensor 161 and the posture information of the second magnetic sensor 162 , the posture information of the head end pipe section 11 is acquired and displayed.

[0135] Furthermore, the first magnetic sensor 161 and the second magnetic sensor 162 are symmetrically arranged inside the adjustable curved section 12 and located on opposite sides, and the method for obtaining the position information of the head end pipe section 11 includes:

[0136] Acquire the middle position information of the head-end pipe section 11 according to the acquired position information of the first magnetic sensor 161 and the acquired position information of the second magnetic sensor 162;

[0137] An image model is obtained by simulating the intermediate information of the head-end pipe segment, and the image model is used to represent the position and posture of the head-end pipe segment;

[0138] The image model is displayed.

[0139] Furthermore, the first magnetic sensor 161 and the second magnetic sensor 162 are symmetrically arranged inside the adjustable bend section 12 and located on the same side, and the method for obtaining the position information of the head end pipe section 11 includes:

[0140] Acquire position information of one side of the head-end pipe section 11 according to the acquired position information of the first magnetic sensor 161 and the acquired position information of the second magnetic sensor 162;

[0141] An image model is obtained by simulating the position information of one side of the head-end pipe segment, and the image model is used to represent the position and posture of the head-end pipe segment;

[0142] The image model is displayed.

[0143] Further, when both the first magnetic sensor 161 and the second magnetic sensor 162 are five-degree-of-freedom sensors, the step of obtaining the intermediate position information of the head-end pipe section includes:

[0144] The posture information of a six-degree-of-freedom sensor is synthesized according to the posture information of the two five-degree-of-freedom sensors, and the middle position information or one side position information of the head-end pipe section is obtained by using the posture information of the six-degree-of-freedom sensor.

[0145] It should be understood that the present invention has no particular restrictions on the type of positioning processing unit 31, which can be hardware that performs logical operations, such as a single-chip microcomputer, a microprocessor, a programmable logic controller (PLC) or a field programmable gate array (FPGA), or a software program, functional module, function, object library or dynamic link library that implements the above functions based on hardware. Or, it is a combination of the above two. Based on the content disclosed in this application, a person skilled in the art should know how to specifically implement the functions of the positioning processing unit.

[0146] The above description is only a description of the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention. Any changes or modifications made by a person skilled in the art in the field of the present invention based on the above disclosure shall fall within the protection scope of the present invention.

Claims

1. A medical catheter, It is characterized in that It includes a traction ring, a catheter body, a first magnetic sensor and a second magnetic sensor; the catheter body includes a head end pipe section, an adjustable bend section and a non-adjustable bend section which are axially connected in sequence; the first magnetic sensor and the second magnetic sensor are both fixedly arranged inside the adjustable bend section, the first magnetic sensor and the second magnetic sensor are located on opposite sides of the adjustable bend section, or the first magnetic sensor and the second magnetic sensor are located on the same side of the adjustable bend section and are distributed along the axial direction; the traction ring is arranged inside the distal end of the adjustable bend section; the first magnetic sensor and the second magnetic sensor are arranged between the traction ring and the dividing line between the head end pipe section and the adjustable bend section, or at least a part of the first magnetic sensor and at least a part of the second magnetic sensor are arranged on the traction ring.

2. The medical catheter according to claim 1, It is characterized in that The first magnetic sensor and the second magnetic sensor are symmetrically arranged inside the adjustable bending section.

3. The medical catheter according to claim 1 or 2, It is characterized in that The first magnetic sensor and the second magnetic sensor are arranged in parallel or non-parallel.

4. The medical catheter according to claim 1 or 2, It is characterized in that The first magnetic sensor and the second magnetic sensor are arranged at an angle, and the angle is 5° to 175°.

5. The medical catheter according to claim 4, It is characterized in that The angle is 90°.

6. The medical catheter according to claim 1, It is characterized in that The medical catheter further comprises a traction wire, which is movably arranged in the catheter body, one end of which is connected to the traction ring, and the traction wire and the traction ring cooperate to control the bending direction of the adjustable bending section.

7. The medical catheter according to claim 6, It is characterized in that The first magnetic sensor and the second magnetic sensor each have a relative connection end and a free end, and the free end of the first magnetic sensor and / or the free end of the second magnetic sensor is located at the dividing line, or, at a radial section of the catheter body along the dividing line, the free end of the first magnetic sensor and / or the free end of the second magnetic sensor is aligned with the dividing line.

8. The medical catheter according to claim 6, It is characterized in that The catheter body includes an inner tube and an outer tube, and the traction ring is sleeved on the inner tube; the medical catheter also includes a mounting component, which is located inside the adjustable bend section and fixedly mounted on the inner tube; The mounting component is provided with a first positioning groove and a second positioning groove; a part of the first magnetic sensor is provided in the first positioning groove, and another part is provided on the inner tube; a part of the second magnetic sensor is provided in the second positioning groove, and another part is provided on the inner tube; or, The first magnetic sensor is entirely disposed in the first positioning groove, and the second magnetic sensor is entirely disposed in the second positioning groove.

9. The medical catheter according to claim 8, It is characterized in that The mounting component is made of a developing material, or an outer surface of the mounting component is coated with a developing material.

10. The medical catheter according to claim 8 or 9, It is characterized in that The mounting component comprises a structural member, which is arranged at the distal end of the traction ring.

11. The medical catheter according to claim 10, It is characterized in that The structural member includes a first positioning block and a second positioning block, the first positioning block and the second positioning block are both triangular blocks and are symmetrically arranged on the inner layer tube; the first positioning groove is arranged on the first positioning block, and the second positioning groove is arranged on the second positioning block; or, the structural member is a hollow cylindrical body and is sleeved on the inner layer tube, and the first positioning groove and the second positioning groove are both arranged on the outer circumferential surface of the hollow cylindrical body.

12. The medical catheter according to claim 8 or 9, It is characterized in that The traction ring is used as the mounting part.

13. The medical catheter according to claim 1 or 2, It is characterized in that The first magnetic sensor and the second magnetic sensor are both five-degree-of-freedom sensors.

14. The medical catheter according to claim 1 or 2, It is characterized in that The medical catheter is a guide sheath or an electrophysiological catheter.

15. A three-dimensional magnetic positioning system, It is characterized in that A medical catheter comprising a positioning device and any one of claims 1 to 14; The positioning device includes a positioning processing unit and a display unit; the first magnetic sensor and the second magnetic sensor are respectively connected to the positioning processing unit for communication; The positioning processing unit is configured to obtain the position information of the first magnetic sensor and the position information of the second magnetic sensor, and obtain the position information of the head end pipe section according to the obtained position information of the first magnetic sensor and the position information of the second magnetic sensor; The display unit is communicatively connected to the positioning processing unit, and is configured to receive and display the position information of the head end pipe segment.

16. The three-dimensional magnetic positioning system according to claim 15, It is characterized in that The first magnetic sensor and the second magnetic sensor are symmetrically arranged inside the adjustable bending section and located on two opposite sides; The positioning processing unit is configured to obtain the middle position information of the head end pipe section according to the obtained position information of the first magnetic sensor and the position information of the second magnetic sensor, and simulate an image model through the middle position information of the head end pipe section; The image model is used to represent the position and posture of the head end pipe segment, and the image model is displayed through the display unit.

17. The three-dimensional magnetic positioning system according to claim 16, It is characterized in that The first magnetic sensor and the second magnetic sensor are both five-degree-of-freedom sensors; The positioning processing unit is configured to synthesize the posture information of a six-degree-of-freedom sensor based on the posture information of the two five-degree-of-freedom sensors, and use the posture information of the six-degree-of-freedom sensor to obtain the middle position information of the head-end pipe segment.

18. A three-dimensional magnetic positioning system according to any one of claims 15 to 17, It is characterized in that The positioning processing unit is further configured to perform graphical processing on the position and posture information of the head end pipe segment; The display unit is configured to receive and display the graphically processed posture information.

19. A method for positioning a medical catheter, It is characterized in that Based on the medical catheter according to any one of claims 1 to 14, the positioning method comprises: Acquiring position information of the first magnetic sensor and position information of the second magnetic sensor; According to the acquired posture information of the first magnetic sensor and the posture information of the second magnetic sensor, the posture information of the head end pipe section is acquired and displayed.

20. The method for positioning a medical catheter according to claim 19, It is characterized in that The first magnetic sensor and the second magnetic sensor are symmetrically arranged inside the adjustable bend section and located on opposite sides, and the method for obtaining the position information of the head end pipe section includes: Acquire the middle position information of the head-end pipe section according to the acquired position information of the first magnetic sensor and the position information of the second magnetic sensor; An image model is obtained by simulating the intermediate information of the head-end pipe segment, and the image model is used to represent the position and posture of the head-end pipe segment; The image model is displayed.

21. The method for positioning a medical catheter according to claim 20, It is characterized in that The first magnetic sensor and the second magnetic sensor are both five-degree-of-freedom sensors, and the step of obtaining the intermediate position information of the head end pipe section includes: The posture information of a six-degree-of-freedom sensor is synthesized according to the posture information of the two five-degree-of-freedom sensors, and the middle position information of the head-end pipe section is acquired by using the posture information of the six-degree-of-freedom sensor.

Images