Medical catheter and three-dimensional magnetic positioning system

Abstract

The present invention provides a medical catheter and a three-dimensional positioning system. The medical catheter comprises a catheter body, a first magnetic sensor, and a second magnetic sensor. The catheter body comprises a head end section, an adjustable bend section, and a straight section, which are connected in axial sequence. The first and second magnetic sensors are both located on the head end section. This system provides more precise positioning of the medical catheter, thereby improving the control accuracy of the medical catheter.

Description

Technical Field

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

[0002] Cardiovascular disease poses a serious threat to human health, with high rates of morbidity, disability, and mortality. Currently, minimally invasive interventional procedures have become a relatively effective method for the clinical diagnosis and treatment of cardiovascular disease. These procedures require the use of medical catheters of various structures, shapes, and sizes. During the design and manufacturing process of medical catheters, the distal tip is pre-shaped into different bends depending on the intended use, adapting it to the anatomical morphology of the specific lesion site and facilitating the alignment of the distal tip of the catheter within the human body. In recent years, medical catheters with pre-shaped distal tips of various shapes and angles have been developed and put into clinical use. However, due to individual differences in human anatomy, even pre-shaped distal catheters designed for a specific anatomical structure cannot adapt to individual physiology and anatomy. This often requires replacement of pre-shaped catheters with different shapes during surgery, increasing the surgical burden on the patient. Consequently, adjustable distal tip bending technology has been developed in recent years. This allows the distal tip of the medical catheter to be repeatedly adjusted externally to accommodate varying anatomical morphologies.

[0003] Traditional electrophysiology interventional procedures are performed in a two-dimensional environment. Under the guidance of an X-ray machine, specialized physicians use a combination of X-ray imaging and maneuvering techniques to guide the distal end of a medical catheter into the lesion within the human body. This procedure is time-consuming, inaccurate, and carries a high risk. Furthermore, even physicians with extensive experience in electrophysiology interventional procedures still require multiple X-rays to visualize the heart's shape and determine the catheter's position, exposing both patients and physicians to significant radiation exposure.

[0004] Based on this, existing medical catheters with force-sensing magnetic positioning and controllable bending have emerged. These catheters sense the contact force between the distal end of the catheter and tissue, as well as its distal position information. Based on this measured contact force and position information, they calculate a contact force vector to identify specific anatomical structures. For example, when the distal end of a medical catheter enters a pulmonary vein ostium and slides outward, the direction of the contact force vector changes dramatically. This change in the direction of the contact force vector allows a physician to determine that the distal end of the medical catheter is currently located at the pulmonary vein ostium. When a medical catheter with magnetic positioning is used in conjunction with a three-dimensional positioning device, the device can estimate the location of the distal end of the catheter in contact with tissue on an electroanatomical map of the heart based on the position signal and contact force vector of the distal end, thereby updating the electroanatomical map. Furthermore, the device can calculate the bending direction based on the contact force and position information of the distal end of the medical catheter. This allows the physician to precisely control the medical catheter, ensuring that the distal end of the medical catheter is in contact with the target tissue and assessing its contact, avoiding the need for X-rays to determine the contact, reducing radiation damage to both the physician and the patient, and improving surgical safety. However, this type of medical catheter in the prior art has the problem that the magnetic positioning sensor is not set in an appropriate position, resulting in inaccurate positioning. Summary of the Invention

[0005] The purpose of the present invention is to provide a medical catheter and a three-dimensional magnetic positioning system, which aims to accurately locate and display the position of the head end section of the medical catheter through a magnetic sensor, thereby improving the control accuracy of the medical catheter and the accuracy of interventional surgery, while protecting both doctors and patients from radiation and improving surgical safety.

[0006] To achieve the above-mentioned objectives, the present invention provides a medical catheter, 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 straight pipe section axially connected in sequence; the first magnetic sensor and the second magnetic sensor are both arranged on the head-end pipe section.

[0007] Optionally, the first magnetic sensor and the second magnetic sensor are arranged at an angle.

[0008] Optionally, the angle formed by the first magnetic sensor and the second magnetic sensor is 5° to 175°.

[0009] Optionally, the head end pipe section includes a structural member, a proximal end of the structural member is connected to the adjustable bend section; and the first magnetic sensor is arranged on the structural member.

[0010] Optionally, a first channel is provided on the structural member, and an axis of the first channel is arranged at an angle to an axis of the structural member;

[0011] The first magnetic sensor is at least partially disposed in the first channel.

[0012] Optionally, the second magnetic sensor is arranged on the structural member.

[0013] Optionally, a second channel is further provided on the structural member, and the second channel and the first channel are arranged at intervals along the circumference of the structural member, and the axis of the second channel is set at an angle to the axis of the first channel; the second magnetic sensor is at least partially set in the second channel.

[0014] Optionally, the axis of the second channel is arranged parallel to the axis of the structural member.

[0015] Optionally, the structural member is further configured to have ferromagnetism, and the second magnetic sensor includes an induction coil, and the induction coil is at least partially wound around the outer circumference of the structural member; or,

[0016] The structural member includes a non-ferromagnetic structural member body and a ferromagnetic core tube sleeved outside the structural member body, and the first channel is arranged in the structural member body; the second magnetic sensor includes an induction coil, and the induction coil is at least partially wound around the outer circumference of the ferromagnetic core tube.

[0017] Optionally, the angle formed by the axis of the first channel and the axis of the structural component is 5° to 10°.

[0018] Optionally, the structural member is provided with one first channel and three second channels arranged at intervals along its circumference; the second channels are arranged at an angle to the first channels; and on the radial cross-section of the structural member, the contour line of each second channel is at least partially open.

[0019] Optionally, the second channel is used to install the second magnetic sensor, or to pass the second magnetic sensor and a wire of the second magnetic sensor, or to allow a medium to flow;

[0020] In the circumferential direction of the structural member, one of the three second channels is arranged opposite to the first channel, and the other two second channels are respectively located on both sides of the first channel; and in the radial cross-section of the structural member, the contour line of each second channel includes an arcuate edge and two straight edges respectively connected to the two ends of the arcuate edge.

[0021] Optionally, the straight side of the second channel arranged opposite to the first channel is parallel to the connecting line between the center of the first channel and the center of the arcuate side of the second channel arranged opposite to it; the straight side of one of the other two second channels is perpendicular to the connecting line, and the straight side of the other is inclined relative to the connecting line, and the distance from the center of the arcuate side of the other to the center of the arcuate side of the second channel arranged opposite to the first channel is less than the distance from the center of the arcuate side of the other to the center of the first channel.

[0022] Optionally, the head end pipe section includes a head electrode, the head electrode is placed at the distal end of the head end pipe section, a third channel is provided on the head electrode, and the second magnetic sensor is at least partially disposed in the third channel.

[0023] Optionally, the first magnetic positioning sensor and the second magnetic sensor are staggered with each other in the circumferential direction and the axial direction of the head end pipe section.

[0024] Optionally, the axis of the third channel is parallel to the axis of the head electrode.

[0025] Optionally, the head end pipe section further includes an elastic body, on which a strain sensor is provided, and the strain sensor is used to sense the magnitude of the external force applied to the head end pipe section when the head end pipe section is deformed.

[0026] Optionally, the medical catheter further includes a third magnetic sensor and a fourth magnetic sensor, wherein the third magnetic sensor and the fourth magnetic sensor are arranged in the straight pipe section and located at the distal end of the straight pipe section; the third magnetic sensor and the fourth magnetic sensor are arranged at an angle.

[0027] Optionally, the first magnetic sensor, the second magnetic sensor, the third magnetic sensor and the fourth magnetic sensor are all five-degree-of-freedom sensors.

[0028] To achieve the above-mentioned object, the present invention further provides a three-dimensional magnetic positioning system, comprising a positioning device and a medical catheter as described in any of the preceding items;

[0029] The positioning device includes a positioning processing unit and a display unit; the first magnetic sensor and the second magnetic sensor are both used to communicate with the positioning processing unit;

[0030] 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, and obtain the posture information of the head-end pipe section according to the posture information of the first magnetic sensor and the posture information of the second magnetic sensor;

[0031] The display unit is in communication with the positioning processing unit and is configured to receive and display the position information of the head end pipe segment.

[0032] Optionally, when the medical catheter further includes a third magnetic sensor and a fourth magnetic sensor, the third magnetic sensor and the fourth magnetic sensor are disposed within the straight tube section and located at the distal end of the straight tube section; the third magnetic sensor and the fourth magnetic sensor are both configured to communicate with the positioning processing unit;

[0033] The positioning processing unit is further configured to obtain the posture information of the third magnetic sensor and the posture information of the fourth magnetic sensor, and obtain the posture information of the far end of the straight pipe section based on the posture information of the third magnetic sensor and the posture information of the fourth magnetic sensor; and obtain the posture information of the adjustable bend section based on the posture information of the head end pipe section and the posture information of the far end of the straight pipe section;

[0034] The display unit is configured to receive and display the posture information of the adjustable bending section.

[0035] Optionally, the positioning processing unit is configured to perform graphical processing on the posture information of the head end pipe section and the posture information of the adjustable bend section, the display unit is configured to receive and display the posture information after the graphical processing, and / or, the positioning processing unit is further configured to obtain the expected bending direction of the adjustable bend section based on the posture information of the head end pipe section.

[0036] Optionally, the medical catheter further comprises a strain sensor, which is provided on the head end tube section and is used to sense the magnitude of the external force when the head end tube section is subjected to an external force and deformed; the strain sensor is used to communicate with the positioning processing unit;

[0037] The positioning processing unit is further configured to obtain a force vector applied to the head-end pipe segment according to the posture information of the head-end pipe segment and the magnitude of the external force applied to the head-end pipe segment;

[0038] The display unit is configured to receive and display the force vector.

[0039] Compared with the prior art, the medical catheter and three-dimensional magnetic positioning system of the present invention have the following advantages:

[0040] The aforementioned medical catheter includes a catheter body, a first magnetic sensor, and a second magnetic sensor, wherein the catheter body includes a head-end tube section, an adjustable bend section, and a straight tube section, which are axially connected in sequence; the first magnetic sensor and the second magnetic sensor are both disposed on the head-end tube section. During interventional surgery, the medical catheter can be used in conjunction with a positioning device to locate the position of the head-end tube section within the human body, and under image guidance, the operator can precisely control the bend of the adjustable bend section to ensure that the distal end of the medical catheter reaches the target position and protect both the doctor and the patient from radiation. Since both magnetic sensors are disposed on the head-end tube section, the position of the head-end tube section can be more accurately determined. Furthermore, when the medical catheter is bent, the two magnetic sensors are not affected by the bending control, reducing the risk of magnetic sensor breakage and ensuring the reliability of magnetic positioning. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] The accompanying drawings are provided for a better understanding of the present invention and are not intended to limit the present invention.

[0042] Figure 1 Schematic diagram of an application scenario of a three-dimensional magnetic positioning system provided by an embodiment of the present invention;

[0043] Figure 2 is a schematic structural diagram of a medical catheter provided according to the first embodiment of the present invention;

[0044] Figure 3 1 is a schematic structural diagram of a head end section of a medical catheter provided according to the first embodiment of the present invention;

[0045] Figure 4 yes Figure 3 A schematic diagram of the head end section of the medical catheter shown;

[0046] Figure 5 yes Figure 4 A BB cross-sectional view of the head end tube section of the medical catheter shown;

[0047] Figure 6 is a rotation coordinate diagram of the six-degree-of-freedom sensor in embodiment 1 of the present invention;

[0048] Figure 7 is a cross-sectional view of a medical catheter provided according to embodiment 1 of the present invention;

[0049] Figure 8 yes Figure 7 An enlarged schematic diagram of the medical catheter C is shown;

[0050] Figure 9 A schematic diagram of an end surface of a structural component of a medical catheter provided in accordance with the first embodiment of the present invention;

[0051] Figure 10 yes Figure 9 DD cross-sectional view of the structural member of the medical catheter shown;

[0052] Figure 11 A schematic structural diagram of the head end section of a medical catheter provided in accordance with the second embodiment of the present invention;

[0053] Figure 12 yes Figure 11 The E-direction schematic diagram of the head end section of the medical catheter shown;

[0054] Figure 13 yes Figure 12 FF cross-sectional view of the head end tube section of the medical catheter shown;

[0055] Figure 14 1 is a schematic structural diagram of a head end section of a medical catheter provided according to a third embodiment of the present invention;

[0056] Figure 15 yes Figure 14 A G-direction schematic diagram of the head end section of the medical catheter shown;

[0057] Figure 16 yes Figure 15 HH cross-sectional view of the tip end section of the medical catheter is shown. DETAILED DESCRIPTION

[0058] The following describes the embodiments of the present invention through specific specific examples. Those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the illustrations provided in this embodiment only illustrate the basic concept of the present invention in a schematic manner, and the drawings only show components related to the present invention rather than being drawn according to the number, shape and size of components during actual implementation. During actual implementation, the type, quantity and proportion of each component can be changed at will, and the component layout type may also be more complicated.

[0059] In addition, each embodiment described below has one or more technical features. However, this does not mean that users of the present invention must implement all technical features in any embodiment at the same time, or that they can only implement some or all technical features in different embodiments separately. In other words, as long as implementation is possible, those skilled in the art can, based on the disclosure of the present invention and depending on design specifications or implementation requirements, selectively implement some or all technical features in any embodiment, or selectively implement a combination of some or all technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present invention.

[0060] As used in this specification, the singular forms "a", "an" and "the" include plural objects, and the plural form "a plurality" includes more than two objects, unless the content clearly indicates otherwise. As used in this specification, the term "or" is generally used in the sense of including "and / or", unless the content clearly indicates otherwise, and the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediate medium, and it can be the internal connection of two elements or the interaction relationship between two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances. The term "proximal end" is generally the end close to the operator, and the term "distal end" is generally the end close to the patient (i.e., the end that first enters the patient's body and is close to the lesion).

[0061] The core concept of the present invention is to provide a three-dimensional magnetic positioning system, comprising a positioning device and a medical catheter. The positioning device includes a positioning processing unit and a display unit. 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 straight pipe section, which are axially connected in sequence. The first and second magnetic sensors are both disposed on the head-end pipe section and are respectively in communication with the positioning processing unit. The positioning processing unit is configured to obtain position information from the first and second magnetic sensors, and obtain position information of the head-end pipe section based on the position information from the first and second magnetic sensors. The display unit is in communication with the positioning processing unit and is configured to receive and display the position information of the head-end pipe section. Further preferably, the positioning processing unit can graphically process the position information of the head-end pipe section, and the display unit receives and displays the graphically processed position information. The present invention does not limit the manner in which the positioning processing unit graphically processes the position information. It should be noted 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.

[0062] When performing an interventional procedure using the three-dimensional magnetic positioning system, the position and orientation of the medical catheter's tip section within the human body can be tracked in real time using the first and second magnetic sensors, and displayed synchronously on a display unit. This improves the control accuracy of the medical catheter. For example, when the medical catheter is a guide sheath, it facilitates the rapid establishment of a guide channel within the body. When the medical catheter is an electrophysiology catheter, it facilitates the guidance of the distal end of the medical catheter to the target location. It also protects both the doctor and the patient from radiation exposure, improving the safety of the interventional procedure. In particular, by placing both magnetic sensors on the tip section of the medical catheter, the position and orientation of the tip section can be more accurately determined. Furthermore, placing the magnetic sensors on the tip section prevents it from being affected by the bending control of the adjustable bend section and causing breakage, thus ensuring the reliability of magnetic positioning.

[0063] To make the objects, advantages, and features of the present invention more apparent, the present invention is further described below in detail with reference to the accompanying drawings. It should be noted that the drawings are greatly simplified and not to exact scale, and are intended solely to facilitate and clearly illustrate the embodiments of the present invention. The same or similar reference numerals in the drawings represent the same or similar components.

[0064] like Figure 1 As shown, the embodiment of the present invention relates to a three-dimensional magnetic positioning system, including a medical catheter and a positioning device. The positioning device includes a positioning processing unit 100 and a display unit 200. Figure 2 The medical catheter includes a connected catheter body 300 and a control handle 400. The catheter body 300 includes a head end tube section 310, an adjustable bend section 320, and a straight tube section 330, which are axially connected in sequence. The proximal end of the straight tube section 330 is connected to the control handle 400, and the control handle 400 is used to control the bending of the adjustable bend section 320. The medical catheter can be a guide sheath, a mapping catheter, or an ablation catheter.

[0065] like Figure 3 and Figure 4 As shown, the medical catheter also includes a first magnetic positioning mechanism for locating the position information of the head end tube segment 310. It should be noted that position information includes spatial position information and directional information. The first magnetic positioning mechanism is disposed on the head end tube segment 310. This arrangement provides a more accurate position determination of the head end tube segment 310 and prevents the first magnetic positioning mechanism from being adversely affected during bending of the adjustable bend segment 320, thereby preventing breakage of the first magnetic positioning mechanism and resulting in loss of magnetic positioning functionality.

[0066] In the embodiment of the present invention, the first magnetic positioning mechanism includes a first magnetic sensor 341 and a second magnetic sensor 342. Preferably, please refer to Figure 5The first magnetic sensor 341 and the second magnetic sensor 342 are arranged at an angle on the head-end pipe section 310, and the angle formed between the two is 5° to 175° (inclusive). Preferably, the angle between the two magnetic sensors is 90°. It should be understood that the angle between the two magnetic sensors refers to the angle formed by the axes of the two magnetic sensors when the head-end pipe section 310 is in a straight state.

[0067] During an interventional procedure, both the first magnetic sensor 341 and the second magnetic sensor 342 are communicatively connected to the positioning processing unit 100, for example, via a connecting tail 500 and a device connector 600. The positioning processing unit 100 is configured to obtain the position information of the first magnetic sensor 341 and the second magnetic sensor 342, and then obtain the position information of the head-end pipe segment 310 based on the position information of the first magnetic sensor 341 and the second magnetic sensor 342. The display unit 200 is configured to receive and display the position information of the head-end pipe segment 310, allowing the operator to understand the current position of the head-end pipe segment 310 in real time. Furthermore, the positioning processing unit 100 is also used to obtain the expected bending direction of the adjustable bend section 320 based on the posture information of the head end tube section 310, and the display unit 200 is used to receive and display the expected bending direction of the adjustable bend section 320. The operator can then manipulate the control handle 400 to make the adjustable bend section 320 bend according to the expected bending direction to improve the control accuracy of the medical catheter.

[0068] Optionally, both the first magnetic sensor 341 and the second magnetic sensor 342 are five-degree-of-freedom sensors. This arrangement allows the first magnetic sensor 341 and the second magnetic sensor 342 to be combined into a six-degree-of-freedom sensor. This is equivalent to tracking the position of the head-end tube section 310 using a single six-degree-of-freedom sensor, resulting in excellent positioning. Compared to directly using a six-degree-of-freedom sensor, this approach occupies less space and is less expensive, thus reducing both the size and manufacturing cost of the medical catheter.

[0069] Based on the structure of the medical catheter, the positioning processing unit 100 is configured to synthesize the pose information of a six-degree-of-freedom sensor based on the pose information of the first magnetic sensor 341 and the pose information of the second magnetic sensor 342, and to obtain the pose information of the head-end tube section 310 based on the pose information of the six-degree-of-freedom sensor. In the present invention, the method of synthesizing a six-degree-of-freedom sensor using two five-degree-of-freedom sensors is prior art, and therefore, this synthesis method is not described in detail.

[0070] It should be understood that the synthesized 6-DOF sensor can rotate and move freely within space, and the position, rotation, and movement of the synthesized 6-DOF sensor correspond to the position, rotation, and movement of the tip tube segment 310. This configuration allows the 6-DOF sensor to accurately determine the position and orientation of the tip tube segment 310, thereby improving the positioning accuracy of the medical catheter, facilitating improved control precision of the medical catheter, and facilitating rapid and accurate delivery of the distal end of the medical catheter to the lesion.

[0071] The directional information of the head-end pipe section 310 is mainly obtained by obtaining the angle information of the head-end pipe section 310, 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 directional information of the head-end pipe section 310 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 angle θ, the rotation matrix R can be obtained based on the quaternion:

[0072]

[0073] 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 new reference system is obtained from a fixed and known reference system through a series of basic rotations. 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.

[0074] When the posture of the head end pipe segment 310 is expressed using Euler angles, it is first described using the following matrix:

[0075]

[0076] Formula (1-1) is equivalent to

[0077] in:

[0078] r 11 =cos θ+x 2 (1-cosθ); r 12 = -zsinθ+xy(1-cosθ);

[0079] r 13=ysinθ+xz(1-cosθ); r 21 =zsinθ+xy(1-cosθ);

[0080] r 22 =cosθ+y 2 (1-cosθ); r 23 = -xsinθ+yz(1-cosθ);

[0081] r 31 =-ysinθ+xz(1-cosθ); r 32 =xsinθ+yz(1-cosθ);

[0082] r 33 =cosθ+z 2 (1-cosθ). α is the angle between the x-axis and the N-axis, representing rotation about the z-axis; β is the angle between the z-axis and the Z-axis, representing rotation about the N-axis; γ is the angle between the N-axis and the x-axis, representing rotation about the Z-axis.

[0083] Then, the corresponding Euler angle can be obtained through the rotation matrix R:

[0084] θ x =atan2(r 32 , r 33 ),

[0085]

[0086] θ z =atan2(r 21 , r 11 ),

[0087] Where: θ x ,θ v and θ z The Euler angles 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 by the Euler angles, that is, the posture of the head end pipe section 310 can be determined.

[0088] Those skilled in the art will appreciate that when the relative positions of two magnetic sensors (e.g., the first magnetic sensor 341 and the second magnetic sensor 342) remain fixed and have a certain angle between them, the spatial position of each magnetic sensor can be determined. For example, a magnetic field generator is provided external to the magnetic sensor. The magnetic field generates an induced current on the magnetic sensor, which is fed back to the positioning processing unit 100. The positioning processing unit 100 processes the position of the magnetic sensor in the magnetic field and ultimately determines the specific spatial position of the magnetic sensor. When the two magnetic sensors are relatively fixed and the angle between them is fixed, when the medical catheter rotates, the spatial position of the head-end pipe section 310 can be obtained based on the spatial coordinates of the two magnetic sensors, thereby achieving real-time tracking of the head-end pipe section 310. In an embodiment of the present invention, the head-end pipe section 310 may include a structural member 312 for mounting at least one magnetic sensor, such as the first magnetic sensor 341.

[0089] Furthermore, in an embodiment of the present invention, the head-end tube segment 310 is capable of deforming when subjected to an external force. In actual operation, the external force is, for example, the contact force when the head-end tube segment 310 contacts human tissue. The medical catheter further includes a strain sensor (not shown in the figure), which is disposed on the head-end tube segment 310 and is used to sense the magnitude of the contact force applied to the head-end tube segment 310 when the head-end tube segment 310 contacts human tissue and deforms. The strain sensor 310 is used to communicate with the positioning processing unit 100. The positioning processing unit 100 is further used to obtain the force vector applied to the head-end tube segment 310 based on the position information of the head-end tube segment 310 and the magnitude of the contact force applied to the head-end tube segment 310. The operator can judge the contact between the head-end tube segment 310 and the human tissue based on the force vector applied to the head-end tube segment 310.

[0090] For details, please refer to Figure 3The head end tube section 310 may include an elastic body 311. When the elastic body 311 is deformed by an external force, the head end tube section 310 is also deformed. The elastic body 311 may be axially connected to the structural member 312, wherein the proximal end of the structural member 312 is connected to the distal end of the adjustable bend section 320. Alternatively, the head end tube section 310 may further include a head electrode 313, and the head electrode 313 is connected to the distal end of the elastic body 311. The material of the elastic body 311 is a soft and deformable polymer material. When the head end tube section 310 contacts human tissue and there is a contact force between the two, the elastic body 311 is deformed by the force, so that the strain sensor can be installed on the elastic body 311. The material of the structural member 312 is stainless steel or other polymer materials with a certain toughness. The head electrode 313 may be a platinum-iridium alloy electrode, which can be used to sense electrophysiological signals and / or perform ablation.

[0091] Typically, the outer diameter of the elastomer 311 is smaller than the outer diameter of the adjustable bend section 320. By providing the structural member 312, on the one hand, the coaxiality of the elastomer 311 and the head electrode 313 with the adjustable bend section 320 can be ensured. On the other hand, it also facilitates the installation of the first magnetic positioning mechanism (for example, for installing the first magnetic sensor and the second magnetic sensor, or only for installing the first magnetic sensor, and the second magnetic sensor is installed on the head electrode 313. The specific installation method will be introduced in detail later). In addition, the toughness of the structural member 312 itself can also protect the magnetic sensor installed thereon, thereby avoiding damage to the magnetic sensor due to the force applied to the head end pipe section 310.

[0092] It should be understood that when the medical catheter is a guide sheath, the head end tube segment 310 may not include the head electrode 313, and when the head end tube segment 310 includes the head electrode 313, the head end tube segment 310 may have mapping and / or ablation functions.

[0093] For further information, please refer to Figure 7 and Figure 8The medical catheter may also include a second magnetic positioning mechanism disposed within the straight tube section 320 and located at the distal end of the straight tube section 330 (i.e., adjacent to the adjustable bend section 320), for locating the distal end of the straight tube section 330. The second magnetic positioning mechanism includes a third magnetic sensor 351 and a fourth magnetic sensor 352. Both the third magnetic positioning sensor 351 and the fourth magnetic sensor 352 are communicatively connected to the positioning processing unit 100 (this can be achieved via the aforementioned connecting tail 500 and the device connector 600). The positioning processing unit 100 is used to obtain the position information of the third magnetic positioning sensor 351 and the position information of the fourth magnetic positioning sensor 352, and obtain the position information of the far end of the straight pipe section 330 based on the position information of the third magnetic positioning sensor 351 and the position information of the fourth magnetic positioning sensor 352. In addition, the position information of the adjustable bend section 320 (i.e., the bend shape of the adjustable bend section 320) is obtained based on the position information of the head end pipe section 310 and the position information of the far end of the straight pipe section 330. The display unit 200 is used to receive and display the position information of the adjustable bend section 320.

[0094] Similar to the first magnetic positioning mechanism, the third magnetic positioning sensor 351 and the fourth magnetic sensor 352 are also arranged at an angle. The third magnetic sensor 351 and the fourth magnetic sensor 352 are preferably five-degree-of-freedom sensors, and the third magnetic sensor 351 and the fourth magnetic sensor 352 are combined into a six-degree-of-freedom sensor to track the position of the distal end of the straight pipe section 330. Therefore, the positioning processing unit 100 is configured to synthesize the position information of the six-degree-of-freedom sensor based on the position information of the third magnetic sensor 351 and the position information of the fourth magnetic sensor 352, and obtain the position information of the distal end of the straight pipe section 330 based on the position information of the six-degree-of-freedom sensor.

[0095] Furthermore, the positioning processing unit is further configured to graphically process the posture information of the head end pipe section 310 and the posture information of the adjustable bend section 320. The display unit 200 is configured to receive and display the posture information after the graphical processing.

[0096] Next, the structure of the medical catheter will be further described in detail with reference to several preferred embodiments. The following embodiments utilize an example in which the tip section includes a tip electrode (i.e., the medical catheter has mapping and / or ablation functions). The following description only highlights the differences between the present invention and the prior art. However, it should be understood that the following embodiments are not intended to limit the present invention.

[0097] <Example 1>

[0098] Please refer back to Figures 3 to 5 and Figure 9 、 Figure 10 In this embodiment, both the first magnetic sensor 341 and the second magnetic sensor 342 are disposed on the structural member 312. Specifically, the structural member 312 is provided with a first channel 314 and at least one second channel 315 spaced apart along its circumference. The axis of the first channel 314 forms an angle with the axis of the second channel 315. Preferably, the axis of the first channel 314 forms an angle with the axis of the structural member 312, preferably between 5° and 10°. The axis of the second channel 315 is parallel to the axis of the structural member 312. The first magnetic sensor 341 is at least partially disposed in the first channel 314, and the second magnetic sensor 342 is at least partially disposed in one of the second channels 315. As a result, the angle formed by the first and second magnetic sensors 341 and 342 is between 5° and 10°. Furthermore, the first and second magnetic sensors 341 and 342 are staggered along the circumference of the structural member 312, reducing mutual interference and improving positioning accuracy. It can be understood that the axis of the first channel 314 is related to the shape of its cross section, and the axis of the second channel 315 is also related to the shape of its cross section, which will be explained later.

[0099] In addition, please refer to Figure 5 In this embodiment, the distance from the axis of the first channel 314 to the axis of the structural member 312 gradually decreases from the proximal end to the distal end, and preferably, the distal end of the first magnetic sensor 341 extends out of the first channel 314 and extends into the elastomer 311, and the proximal end of the second magnetic sensor 342 extends out of the second channel 315 and extends into the adjustable bend section 320. The advantage is that the axial length of the structural member 312 is reduced, the interference with the deformation of the head end pipe section 310 is reduced, and the space utilization rate can also be improved.

[0100] Since the head end tube section 310 includes the head electrode 313, the number of the second channels 315 can be three, one of which can be used to install the second magnetic sensor 342, another of which can be used to pass sensor wires and / or other wires (such as force sensor wires, temperature sensor wires, and / or wires of the head electrode 313), and another of which can be used as a medium channel, the medium being, for example, saline, for cooling the head electrode 313. It should be understood that the adjustable bend section 320 is a multi-lumen tube, the chambers thereon being arranged in a one-to-one correspondence with the three second channels 315. The structure of the adjustable bend section 320 is prior art and will not be described in detail here.

[0101] Please continue to refer to Figure 9, on the radial cross-section of the structural member 312, the shape of the first channel 314 can be a regular structure such as a circle or an ellipse. The second channel 315 can be a special-shaped structure, and the outline of each second channel 315 is at least partially open. The open setting means that the second channel 315 has an open outline. The second channel 315 located in the middle is arranged opposite to the first channel 314, and the other two second channels 315 are distributed on both sides of the first channel 314. Furthermore, the outline of each second channel 315 includes an arcuate edge and two straight edges respectively connected to the two ends of the arcuate edge, and the two straight edges of each second channel 315 are parallel to each other. In this embodiment, the straight edge of the second channel 315 (i.e., the second channel 315 in the middle) arranged opposite to the first channel 314 is parallel to the connecting line d of the center of the circle of the first channel 314 and the center of the arcuate edge of the second channel 315 opposite to it. The straight side of one of the two second channels 315 located on both sides of the first channel 314 is perpendicular to the connecting line d, and the straight side of the other is inclined relative to the connecting line d, and the arcuate side of the other is closer to the second channel 315 arranged opposite the first channel 314, that is, the distance from the center of the arcuate side of the other to the center of the arcuate side of the second channel 315 arranged opposite the first channel 314 is smaller than the distance from the center of the arcuate side of the other to the center of the first channel 314. Figure 9 Taking the orientation shown as an example, the straight edge of the second channel 315 located to the left of the first channel 314 is perpendicular to the connecting line d, while the straight edge of the second channel 315 located to the right of the first channel 314 is tilted upward. This arrangement is intended to improve the spatial utilization of the structural member 312, maximize the angle between the first magnetic sensor 341 and the second magnetic sensor 342 while maintaining the radial dimensions of the structural member 312, and accommodate the layout of the various wires within the catheter body. It should be noted that in this embodiment, the axis of each second channel 315 refers to a straight line passing through the center of the arcuate edge of the second channel 315.

[0102] Furthermore, in this embodiment, the third magnetic sensor 351 and the second magnetic sensor 352 can be arranged within the distal end of the straight pipe section 330 in any suitable manner, as long as they are arranged at an angle. For example, the third magnetic sensor 351 is arranged on the inner wall of the straight pipe section 330 and is parallel to the axis of the straight pipe section 330, and the fourth magnetic sensor 352 is arranged obliquely within the straight pipe section 330 via an oblique groove fixture 700. Alternatively, the straight pipe section is a double-layer tube, and two oblique grooves arranged at an angle are defined on the outer surface of the inner tube of the straight pipe section, and the third magnetic sensor 351 and the fourth magnetic sensor 352 are each arranged within one of the oblique grooves.

[0103] It should also be noted that the medical catheter also includes an outer sleeve (not shown). Typically, the outer diameter of the elastic body 311 is smaller than the outer diameter of the controllable bend section 320, and the maximum outer diameter of the structural member 312 can be equal to the outer diameter of the controllable bend section 320. The distal end of the structural member 312 can be connected to the slot 311a at the proximal end of the elastic body 311 via a snap-fit ​​structure 312a. The outer sleeve is then fitted over the distal ends of the elastic body 311 and the structural member 312 and connected by glue injection to enhance the bonding strength between the elastic body 311 and the structural member 312. After the outer sleeve is installed, the head end tube section 310 has a smooth outer surface.

[0104] <Example 2>

[0105] The difference between this embodiment and the first embodiment is that Figures 11 to 13 As shown, the structural member 312 is configured to have ferromagnetism, the first magnetic sensor 341 is at least partially disposed within the first channel of the structural member 312, and the second magnetic sensor 342 includes an induction coil that is at least partially wound around the outer circumference of the structural member 312. In this way, two of the three second channels 315 can be used to pass various wires, while the other one remains as a medium channel. Compared to the first embodiment, the advantage of this embodiment is that it can reduce the axial length of the structural member 312, thereby reducing the hard section length of the head end tube section 310, improving the flexible responsiveness of the catheter within the body, and maximizing the angle (acute angle) formed between the first magnetic sensor 341 and the second magnetic sensor 342. Furthermore, by adjusting the length of the first magnetic sensor 341 extending into the elastic body 311, interference with the deformation of the head end tube section 310 can be reduced. The induction coil can be directly wound with enameled wire, or the induction coil can be wound with conductive metal with a dielectric layer provided between two adjacent turns.

[0106] In some implementations, the structural member 312 may be entirely made of ferromagnetic material. Alternatively, in another implementation, such as Figures 11 to 13 As shown, the structural member 312 is a split structure comprising a structural member body 312b and a ferromagnetic core tube 312c. The structural member body 312b is non-ferromagnetic and is provided with the first channel 314 and the second channel 315. The ferromagnetic core tube 312c is sleeved onto the structural member body 312b. As a result, the second magnetic sensor 342 is at least partially wrapped around the outer circumference of the ferromagnetic core tube 312c. This design increases the size of the second magnetic sensor, further enhancing the magnetic sensor signal and improving the accuracy and sensitivity of the resulting six-degree-of-freedom magnetic positioning sensor.

[0107] In this embodiment, the maximum outer diameter of the structural component 312 may be smaller than the outer diameter of the controllable bending section 320 , and the outer sleeve further covers the second magnetic sensor 342 .

[0108] <Example 3>

[0109] The difference between this embodiment and the first embodiment is that the first magnetic sensor 341 is disposed on the structural component 312 , and the second magnetic sensor 342 is disposed on the head electrode 313 .

[0110] Specifically, please refer to Figures 14 to 16 The head electrode 313 is provided with a third channel 316, the axis of which is preferably parallel to the axis of the head electrode 313. It is understood that when the head-end tube section 310 is in a straight state (i.e., the head-end tube section 310 is not deformed), the head electrode 313 and the structural member 312 are coaxially arranged, and thus the axis of the third channel 316 is also parallel to the axis of the structural member 312. The second magnetic sensor 342 is at least partially disposed within the third channel 316. Preferably, the distal end of the second magnetic sensor 342 is located within the third channel 316, while the proximal end extends beyond the third channel 316 and into the elastic body 311. The advantage of this arrangement is that, on the one hand, the second magnetic sensor does not occupy the space of the structural member 312 and the proximal end of the elastomer 311, so that the two magnetic sensors can form a larger angle (acute angle) in a limited space. In this embodiment, the angle formed by the second magnetic sensor 342 and the first magnetic sensor 341 can reach 20°, thereby improving the positioning accuracy of the magnetic sensor; on the other hand, the second magnetic sensor 342 is closer to the distal end of the catheter body, making the positioning of the catheter head end more accurate; on the other hand, the first magnetic sensor 341 and the second magnetic sensor 342 are staggered in the axial direction, which can reduce interference between the two.

[0111] Preferably, the first channel 314 and the third channel 316 are staggered circumferentially along the head-end tube section 310 (i.e., the axis of the first channel 314 is not aligned with the axis of the third channel 316), further reducing interference between the two magnetic sensors. The third channel 316 is aligned with one of the second channels 315, such as the central second channel 315 opposite the first channel 314, to facilitate the arrangement of the wires of the second magnetic sensor 342 and the placement of the medium flow channel 317 at the center of the head electrode 313.

[0112] While the present invention is disclosed above, it is not limited thereto. Those skilled in the art may make various modifications and variations to the present invention without departing from the spirit and scope of the present invention. Thus, the present invention is intended to encompass such modifications and variations as long as they fall within the scope of the claims and their equivalents.

Claims

1. A medical catheter, characterized in that: The device 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 straight pipe section connected in sequence axially; the first magnetic sensor and the second magnetic sensor are both arranged on the head end pipe section; the first magnetic sensor and the second magnetic sensor are arranged at an angle; The head end pipe section includes a structural member, a proximal end of which is connected to the adjustable bend section; a first channel is provided on the structural member, an axis of the first channel is arranged at an angle to an axis of the structural member, and the first magnetic sensor is at least partially disposed in the first channel; The structural member is further configured to have ferromagnetism, the second magnetic sensor includes an induction coil, and the induction coil is at least partially wound around the outer circumference of the structural member; or the structural member includes a non-ferromagnetic structural member body and a ferromagnetic core tube sleeved outside the structural member body, and the first channel is provided in the structural member body; the second magnetic sensor includes an induction coil, and the induction coil is at least partially wound around the outer circumference of the ferromagnetic core tube.

2. The medical catheter according to claim 1, wherein The angle formed by the first magnetic sensor and the second magnetic sensor is 5° to 175°.

3. The medical catheter according to claim 2, wherein: The angle formed by the axis of the first channel and the axis of the structural component is 5° to 10°.

4. The medical catheter according to claim 2, wherein The structural member is provided with one first channel and three second channels spaced apart along its circumference; the second channels are arranged at an angle to the first channels; and on a radial cross section of the structural member, the contour line of each second channel is at least partially open.

5. The medical catheter according to claim 4, characterized in that The second channel is used for passing the guide wire of the medical catheter or for allowing the medium to flow; In the circumferential direction of the structural member, one of the three second channels is arranged opposite to the first channel, and the other two second channels are respectively located on both sides of the first channel; and in the radial cross-section of the structural member, the contour line of each second channel includes an arcuate edge and two straight edges respectively connected to the two ends of the arcuate edge.

6. The medical catheter according to claim 5, characterized in that The straight side of the second channel arranged opposite to the first channel is parallel to the connecting line between the center of the first channel and the center of the arcuate side of the second channel arranged opposite to it; the straight side of one of the other two second channels is perpendicular to the connecting line, and the straight side of the other is inclined relative to the connecting line, and the distance from the center of the arcuate side of the other channel to the center of the arcuate side of the second channel arranged opposite to the first channel is less than the distance from the center of the arcuate side of the other channel to the center of the first channel.

7. The medical catheter according to claim 1, wherein The head end pipe section further includes an elastic body, on which a strain sensor is provided. The strain sensor is used to sense the magnitude of the external force applied to the head end pipe section when the head end pipe section is deformed.

8. The medical catheter according to claim 1, wherein The medical catheter further includes a third magnetic sensor and a fourth magnetic sensor, which are arranged in the straight tube section and located at the distal end of the straight tube section; the third magnetic sensor and the fourth magnetic sensor are arranged at an angle.

9. The medical catheter according to claim 8, characterized in that The first magnetic sensor, the second magnetic sensor, the third magnetic sensor, and the fourth magnetic sensor are all five-degree-of-freedom sensors.

10. A three-dimensional magnetic positioning system, characterized in that: comprising a positioning device and a medical catheter as claimed in any one of claims 1 to 9; The positioning device includes a positioning processing unit and a display unit; the first magnetic sensor and the second magnetic sensor are both used to communicate with the positioning processing unit; 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, and obtain the posture information of the head-end pipe section according to the posture information of the first magnetic sensor and the posture information of the second magnetic sensor; The display unit is in communication with the positioning processing unit and is configured to receive and display the position information of the head end pipe segment.

11. The three-dimensional magnetic positioning system according to claim 10, characterized in that: When the medical catheter further includes a third magnetic sensor and a fourth magnetic sensor, the third magnetic sensor and the fourth magnetic sensor are disposed within the straight tube section and at a distal end of the straight tube section; the third magnetic sensor and the fourth magnetic sensor are both configured to communicate with the positioning processing unit; The positioning processing unit is further configured to obtain the posture information of the third magnetic sensor and the posture information of the fourth magnetic sensor, and obtain the posture information of the far end of the straight pipe section based on the posture information of the third magnetic sensor and the posture information of the fourth magnetic sensor; and obtain the posture information of the adjustable bend section based on the posture information of the head end pipe section and the posture information of the far end of the straight pipe section; The display unit is configured to receive and display the posture information of the adjustable bending section.

12. The three-dimensional magnetic positioning system according to claim 10, characterized in that: The positioning processing unit is configured to perform graphical processing on the posture information of the head end pipe section and the posture information of the adjustable bend section, the display unit is configured to receive and display the posture information after the graphical processing, and / or the positioning processing unit is further configured to obtain the expected bending direction of the adjustable bend section based on the posture information of the head end pipe section.

13. The three-dimensional magnetic positioning system according to claim 10, characterized in that: The medical catheter further includes a strain sensor, which is disposed on the head end tube section and is used to sense the magnitude of the external force when the head end tube section is subjected to an external force and deforms; the strain sensor is used to communicate with the positioning processing unit; The positioning processing unit is further configured to obtain a force vector applied to the head-end pipe segment based on the posture information of the head-end pipe segment and the magnitude of the external force applied to the head-end pipe segment; The display unit is configured to receive and display the force vector.

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