Medical catheters, positioning devices and catheter systems

Abstract

The present invention provides a medical catheter, positioning device, and catheter system. The catheter system includes the medical catheter and the positioning device. An integrated circuit module is installed within the handle housing of the medical catheter. The integrated circuit module is configured to sense the radial orientation and motion state of the handle housing and transmit the sensing results to the positioning device. The positioning device determines the bending direction of the distal end of the medical catheter based on the three-dimensional position of the distal end of the medical catheter, the catheter property parameters of the medical catheter, and the sensing results transmitted by the medical catheter. Using the medical catheter, positioning device, and catheter system provided by the present invention, an operator can obtain real-time feedback on the catheter's rotation around different axial directions based on the bending direction of the distal end of the catheter, thereby reducing unnecessary operations (such as test excitation) during surgery, thereby reducing surgical time and surgical risks.

Description

Technical Field

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

[0002] Overactive nerves can have adverse effects on human organs or tissues, leading to a series of diseases. Common heart diseases, circulatory system diseases (hypertension) or kidney diseases may be caused by overactivity of local sympathetic nerves. For example, chronic activation of the renal sympathetic nerves can cause excessive secretion of one or more renin, leading to increased sodium ion reabsorption by the kidneys or increased cardiac output and ultimately increased blood pressure. In addition, long-term overactivity of the sympathetic nerves can cause excessive levels of certain hormones in the body (such as norepinephrine) that may cause irreversible damage to the internal organs. By inhibiting the activity level of local sympathetic nerves, such symptoms have the opportunity to be treated to a certain extent.

[0003] Radiofrequency ablation (RFA) is a major nerve ablation method that uses radiofrequency energy to generate high temperatures in local tissues, selectively blocking the conduction function of sympathetic nerve fibers in the area and reducing sympathetic nerve excitability, thereby achieving the therapeutic effect of alleviating symptoms (such as hypertension). For example, during renal sympathetic denervation (RDN) for the treatment of refractory hypertension, ablating afferent nerves can reduce nerve impulses to the central nervous system and sympathetic nerve excitability, thereby lowering heart rate, myocardial contractility, and stroke volume, reducing cardiac blood output and thus blood pressure. Ablating efferent nerves can reduce the activity of downstream nerves, thereby increasing the glomerular filtration rate and reducing the renal reabsorption capacity. This reduces the reabsorption of sodium ions and water, leading to increased sodium ions and water excretion, reducing blood volume, and lowering blood pressure.

[0004] Traditional radiofrequency ablation devices do not include any catheter movement or position feedback functions, and the position of the catheter during surgery is usually achieved by additional positioning devices (such as magnetic field positioning devices, electric field positioning devices, etc.). However, due to the axially symmetrical shape of the catheter, it is difficult for conventional positioning devices to identify the bending direction of the catheter through the external features of the catheter. The same is true for ablation devices with other energy sources, such as pulse ablation and cryoablation. Traditional equipment usually requires the operator to test it by themselves during the operation, and then adjust the bending direction of the catheter based on the test results; or mark the bending direction of the catheter on the handle to allow the operator to determine the bending direction of the catheter by identifying the relative position of the device and the human body. These two different types of solutions require the operator to perform different degrees of logical judgment or calculation to determine the bending direction of the catheter, which to a certain extent increases the difficulty of the operation and the risk of misoperation. Summary of the Invention

[0005] An object of the present invention is to provide a medical catheter, a positioning device, and a catheter system to solve one or more problems in the prior art.

[0006] In order to solve the above technical problems, the present invention provides a medical catheter, comprising: a catheter body and a handle, wherein the handle is connected to the proximal end of the catheter body,

[0007] The handle includes a housing and an integrated circuit module disposed within the housing. The integrated circuit module includes a first integrated circuit chip and a second integrated circuit chip. The first integrated circuit chip is used to sense the radial orientation of the housing to obtain a first sensing result. The second current collecting circuit chip is used to sense the movement state of the housing to obtain a second sensing result. The first sensing result and the second sensing result are used to combine with catheter attribute parameters of the medical catheter to obtain the radial orientation of the distal end of the catheter body.

[0008] Optionally, in the medical catheter, the integrated circuit module further includes a fixing member having two mounting grooves, the first integrated circuit chip and the second integrated circuit chip are respectively accommodated in the two mounting grooves, and the upper surfaces of the first integrated circuit chip and the second integrated circuit chip do not exceed the outermost outer surface of the fixing member.

[0009] Optionally, in the medical catheter, the fixing member is a hollow cylindrical structural member, and at least a portion of the outer contour of the fixing member matches the inner contour of the handle.

[0010] Optionally, in the medical catheter, the fixing member has a first limiting structure, and the shell has a second limiting structure, and the first limiting structure and the second limiting structure are matched and connected to define the relative position of the fixing member and the shell.

[0011] Optionally, in the medical catheter, one of the first limiting structure and the second limiting structure is a limiting groove, and the other is a protruding piece.

[0012] Optionally, in the medical catheter, the medical catheter further includes a torque sensor, which is used to sense the torque value of the catheter body affected by the connected handle, and the torque value is used to combine the catheter property parameters of the medical catheter, the first sensing result and the second sensing result to obtain the radial orientation of the end of the catheter body.

[0013] Optionally, in the medical catheter, the torque sensor is provided at the connection between the catheter body and the handle.

[0014] The present invention further provides a positioning device for use with the medical catheter as described in any of the above items, the positioning device comprising: a signal processing unit and a positioning unit; wherein,

[0015] The signal processing unit is configured to determine the radial orientation of the distal end of the catheter body according to the first sensing result and the second sensing result fed back by the handle, and the catheter attribute parameters of the medical catheter;

[0016] The positioning unit is used to locate the three-dimensional position of the distal end of the catheter body, and to determine the bending direction of the distal end of the catheter body according to the three-dimensional position and the radial orientation.

[0017] Optionally, in the positioning device, the positioning device also includes: a positioning display unit, which is used to display a positioning simulation image of the catheter body in the target object, and is used to mark the bending direction of the end of the catheter body on the displayed positioning simulation image according to the judgment result of the positioning unit.

[0018] Optionally, in the positioning device, the positioning display unit has an interactive interface, which is used for the operator to select the catheter type of the medical catheter, and the signal processing unit is further used to call the pre-stored corresponding catheter attribute parameters according to the catheter type selected by the operator on the positioning display unit.

[0019] Optionally, in the positioning device, the signal processing unit is used to determine the radial orientation of the end of the catheter body based on the first sensing result and the second sensing result fed back by the handle, the catheter property parameters of the medical catheter, and the torque value of the catheter body affected by the connected handle.

[0020] The present invention further provides a catheter system, characterized in that it comprises:

[0021] The medical catheter as described in any of the preceding items; and

[0022] The positioning device as described in any of the preceding items, wherein the positioning device is electrically connected to the integrated circuit module of the medical catheter.

[0023] Optionally, in the catheter system, the catheter body includes a radio frequency electrode, and the catheter system further includes a radio frequency transmitter, and the radio frequency transmitter is used to send a radio frequency signal to the radio frequency electrode.

[0024] In summary, the present invention provides a medical catheter, positioning device, and catheter system. The catheter system includes the medical catheter and the positioning device. An integrated circuit module is installed within the handle housing of the medical catheter. The integrated circuit module is used to sense the radial orientation and motion state of the handle housing and transmit the sensing results to the positioning device. The positioning device then determines the bending direction of the distal end of the medical catheter based on the three-dimensional position of the distal end of the medical catheter, the catheter attribute parameters of the medical catheter, and the sensing results transmitted by the medical catheter. Using the medical catheter, positioning device, and catheter system provided by the present invention, an operator can obtain real-time feedback on the catheter's rotation around different axial directions based on the bending direction of the distal end of the catheter, thereby reducing unnecessary operations (such as test excitation) during surgery, thereby reducing surgical time and surgical risks. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 Schematic diagram of the catheter rotating around the X-axis, Y-axis, and Z-axis;

[0026] Figure 2 A schematic diagram of the anatomical structure of a handle provided in an embodiment of the present invention;

[0027] Figure 3 A schematic diagram of the assembly of a handle provided in an embodiment of the present invention;

[0028] Figure 4 The handle provided by the embodiment of the present invention is Figure 3 Schematic diagram of the cross-sectional structure of the middle AA region;

[0029] Figure 5 This is a schematic structural diagram of an integrated circuit module according to an embodiment of the present invention;

[0030] Figure 6 A schematic diagram of the composition of a catheter system provided in an embodiment of the present invention;

[0031] Figure 7 Schematic diagram of the relationship between the radial direction of the catheter tip and the radial direction of the catheter handle in an embodiment of the present invention;

[0032] Figure 8 This is a flowchart of the working process of the catheter system in an embodiment of the present invention;

[0033] Figure 9 Schematic diagram of the effect of handle rotation on the bending direction of the catheter in an embodiment of the present invention;

[0034] Figure 10 Schematic diagram of the effect of handle rotation on the bending direction of the catheter when the catheter is bent in an embodiment of the present invention;

[0035] The descriptions of the reference numerals are as follows:

[0036] 1-handle; 2-main body; 3-bendable section; 4-electrode;

[0037] 5-RF transmitter; 6-signal processing unit; 7-positioning display unit; 8-positioning unit;

[0038] 9- Positioning device; 10- Medical catheter;

[0039] 11-integrated circuit module; 12-housing;

[0040] 13-Hollow structure characteristics;

[0041] 14a, 14b-mounting slots;

[0042] 15a, 15b-first limiting structure; 16-fixing member;

[0043] 17-first integrated circuit chip; 18-second integrated circuit chip;

[0044] 29-push rod; 30-bending direction; 31-right kidney; 32-renal artery. DETAILED DESCRIPTION

[0045] In order to make the objects, advantages and features of the present invention clearer, the present invention is described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that the 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 drawings is often a part of the actual structure. In particular, the emphasis required to be shown in each drawing is different, and sometimes different proportions are used. It should also be understood that, unless otherwise specified or indicated, the terms "first", "second", "third" and the like in the specification are only used to distinguish between the various components, elements, steps, etc. in the specification, and are not used to represent the logical relationship or sequential relationship between the various components, elements, steps, etc.

[0046] In this application document, "proximal" and "distal / terminal" refer to the relative orientation, position, and direction of components or actions relative to each other from the perspective of a doctor using the medical device. Although "proximal" and "distal / terminal" are not restrictive, "proximal" generally refers to the end of the medical device that is closest to the doctor during normal operation, and "distal / terminal" generally refers to the end that first enters the patient's body.

[0047] The catheter has six degrees of freedom of movement inside the human body. Traditional positioning equipment can determine the linear movement of the catheter body in the X, Y, and Z directions and the rotational movement of the catheter body around the Y and Z axes by capturing the appearance characteristics of the catheter (such as Figure 1However, due to the axial symmetry of the catheter body about the X-axis, a single appearance judgment is not enough to distinguish the rotational motion of the catheter around the X-axis (such as Figure 1 (The pitch-like rotational motion shown is shown here.) During actual surgical procedures, the bending direction of the distal end of the catheter is completely controlled by the catheter's rotation around the X-axis. Positioning systems that rely solely on the catheter's external features cannot identify this rotational motion, preventing the operator from receiving effective feedback at the motion input end. Therefore, using traditional positioning systems typically requires the operator to continuously activate the handle push rod to determine whether the catheter will bend in the target direction, which is difficult and carries a high risk of misoperation.

[0048] In view of this, an object of the present invention is to provide a catheter system that can automatically determine the bending direction of the catheter tip. The catheter system includes a catheter itself and a positioning device.

[0049] An embodiment of the present invention provides a medical catheter, comprising a catheter body and a handle, wherein the handle is connected to the proximal end of the catheter body. Figures 2 to 5 As shown, the handle includes a housing 12 and an integrated circuit module 11 disposed within the housing 12. The integrated circuit module 11 includes a first integrated circuit chip 17 and a second integrated circuit chip 18. The first integrated circuit chip 17 is used to sense the radial orientation of the housing 12 to obtain a first sensing result, and the second integrated circuit chip 18 is used to sense the movement state of the housing 12 to obtain a second sensing result. The first sensing result and the second sensing result are used to combine with the catheter attribute parameters of the medical catheter to obtain the radial orientation of the distal end of the catheter body.

[0050] Based on the same idea, see Figure 6 An embodiment of the present invention further provides a positioning device 9, which is used in conjunction with the medical catheter 10 provided in an embodiment of the present invention. The positioning device 9 includes: a signal processing unit 6 and a positioning unit 8; wherein the signal processing unit 6 is used to determine the radial orientation of the distal end of the catheter body based on the first sensing result and the second sensing result fed back by the handle 1, and the catheter attribute parameters of the medical catheter 10; the positioning unit 8 is used to locate the three-dimensional position of the distal end of the catheter body, and to determine the bending direction of the distal end of the catheter body based on the three-dimensional position and radial orientation of the distal end of the catheter body.

[0051] In addition, if Figure 6As shown, an embodiment of the present invention further provides a catheter system, which includes: the medical catheter 10 provided in an embodiment of the present invention and the positioning device 9 , wherein the positioning device 9 is electrically connected to the integrated circuit module 11 of the medical catheter 10 .

[0052] When the medical catheter 10 provided in this embodiment of the present invention is used in conjunction with the positioning device 9, the integrated circuit module 11 disposed within the handle housing 12 of the medical catheter 10 transmits the sensed radial orientation and motion state of the handle housing 12 to the positioning device 9. The positioning device 9 then determines the bending direction of the distal end of the medical catheter 10 based on the located three-dimensional position of the distal end of the medical catheter 10, the catheter attribute parameters of the medical catheter 10, and the data transmitted by the medical catheter 10. Using the medical catheter 10, positioning device 9, and catheter system provided in this embodiment of the present invention, the operator can obtain real-time feedback on the catheter's rotation around different axial directions based on the bending direction of the distal end of the catheter, reducing unnecessary operations (such as test stimulation) during surgery, thereby reducing surgical time and risks.

[0053] The medical catheter 10 , the positioning device 9 , and the catheter system provided in the embodiment of the present invention are described in further detail below.

[0054] As mentioned above, the first integrated circuit chip 17 is used to sense the radial orientation of the shell 12. Specifically, the first integrated circuit chip 17 can be a gravity sensing chip, a gyroscope, etc., but the present application is not limited to this. The second integrated circuit chip 18 is used to sense the motion state of the shell 12. Here, the motion state refers to the motion direction, speed, and acceleration of the shell 12. The second integrated circuit chip 18 can be an acceleration sensing chip, etc., but the present application is not limited to this.

[0055] like Figures 2 to 5 As shown, the first integrated circuit chip 17 and the second integrated circuit chip 18 can be fixed in the housing 12 by a fixing member 16. Preferably, as Figure 3As shown, the fixture 16 has two mounting slots 14a and 14b, which are used to accommodate the first integrated circuit chip 17 and the second integrated circuit chip 18, respectively. The top surfaces of the first integrated circuit chip 17 and the second integrated circuit chip 18 do not extend beyond the outermost surface of the fixture 16. The "outermost surface" herein refers to the outer surface of the fixture 16 radially farthest from the central axis of the fixture 16. The top surfaces of the first integrated circuit chip 17 and the second integrated circuit chip 18 are closer to the central axis of the fixture 16 than the outermost surface. The first integrated circuit chip 17 and the second integrated circuit chip 18 can be secured to the fixture 16 using nylon screws or adhesive. The provision of the two mounting slots 14a and 14b protects the first integrated circuit chip 17 and the second integrated circuit chip 18 from being squeezed or interfered with by the housing 12, thereby ensuring more accurate monitoring data. The present application does not impose any particular limitation on the relative positions of the two mounting grooves 14a and 14b. In this embodiment, the two mounting grooves 14a and 14b can be located on two opposing sides of the fixing member 16. In other embodiments, the two mounting grooves 14a and 14b can also be located side by side. The positions of the mounting grooves 14a and 14b can be adjusted based on the shape of the fixing member 16 and the connection method between the fixing member 16 and the housing 12.

[0056] The accommodation dimensions of the two mounting grooves 14a and 14b can match the dimensions of the first integrated circuit chip 17 and the second integrated circuit chip 18, respectively. Here, the term "matching" means that the bottom areas of the mounting grooves 14a and 14b are equal to the areas of the first integrated circuit chip 17 and the second integrated circuit chip 18, or the bottom areas of the mounting grooves 14a and 14b are larger than the areas of the first integrated circuit chip 17 and the second integrated circuit chip 18. The mounting grooves 14a and 14b can be grooves that surround the first integrated circuit chip 17 and the second integrated circuit chip 18, or, as Figure 5 In summary, the mounting grooves 14a and 14b are arranged so that the upper surfaces of the first integrated circuit chip 17 and the second integrated circuit chip 18 do not exceed the outermost surface of the fixing member 16.

[0057] More preferably, Figures 2 to 5As shown, the fixing member 16 is a hollow cylindrical structure having a hollow structural feature 13. At least a portion of the outer contour of the fixing member 16 matches the inner contour of the handle 1. For example, one end of the fixing member 16 is provided with a cylindrical protrusion having a circular outer contour (in this embodiment, the circular outer contour includes the outermost outer surface), and the handle 1 has a circular inner contour that matches the circular outer contour. When at least a portion of the outer contour of the fixing member 16 matches the inner contour of the handle 1, the connection strength and stability between the fixing member 16 and the handle 1 are improved. Furthermore, the hollow structural feature 13 of the fixing member 16 allows for the passage of wires, catheters, and coolant delivery tubes without affecting the arrangement of the catheter's own structural components.

[0058] Furthermore, the fixing member 16 has a first limiting structure, and the housing 12 has a second limiting structure. The first limiting structure and the second limiting structure are connected in a matching manner to limit the relative position of the fixing member 16 and the housing 12. The number and position of the first limiting structures can be designed according to the setting of the mounting slot, and the number and position of the second limiting structures are matched with the number and position of the first limiting structures. In a preferred embodiment, Figure 5 As shown, the two mounting grooves 14a and 14b are located on two opposite sides of the fixing member 16 along the first direction (groove depth direction), the number of the first limiting structures is two, and the two first limiting structures 15a and 15b are located on the other two opposite sides of the fixing member 16 along the second direction. The first direction intersects with the second direction, and in order to facilitate the arrangement of each structural unit, preferably, the first direction and the second direction are two directions perpendicular to each other, but the present application is not limited to this. For example, in some other embodiments, the number of the first limiting structures may also be only one, which is arranged in a ring shape along the circumference of the fixing member 16, and the two mounting grooves 14a and 14b may also be located on both sides of the first limiting structure, respectively.

[0059] In addition, preferably, one of the first limiting structure and the second limiting structure is a limiting groove, and the other is a protruding member. When the protruding member is inserted into the limiting groove, a stable connection is achieved between the housing 12 and the fixing member 16. When this structural combination design is adopted, the difficulty of connecting the fixing member 16 to the housing 12 can be reduced.

[0060] Figure 5 As shown in the figure, the second limiting structure is a ridge arranged along the axial direction of the fixing member 16, and the first limiting structures 15a and 15b are elongated limiting grooves arranged along the axial direction of the fixing member 16. However, it should be understood that Figure 5 The illustrations do not constitute a limitation to the present application.

[0061] In addition, the medical catheter 10 provided in the embodiment of the present invention has a catheter body that adopts a common catheter body structure, such as Figure 6 As shown, the catheter body includes a main section 2, a bendable section 3, and an electrode section 4, connected sequentially from the proximal end to the distal end (the distal end). The bending direction of the catheter distal end described above corresponds to the bending direction of the distal end of the bendable section 3. The proximal end of the main section 2 is connected to the handle 1. The electrode section 4 may include one or more electrodes and / or one or more sensors. The shape of the electrode section 4 is not limited to linear; it may also be spiral, annular, or other shapes. For non-linear electrode sections such as spiral or annular shapes, they are linear before entering the target area and return to a non-linear working state after positioning. Considering that if the catheter body is long and the elastic modulus of the catheter body is small, the torque between the catheter and the handle will have a certain impact on the final radial orientation of the catheter distal end. Therefore, the medical catheter 10 preferably also includes a torque sensor (not shown) for sensing the torque value of the catheter body affected by the connected handle to improve the accuracy of the final determination result. Preferably, the torque sensor is located at the connection between the main section 2 and the handle 1. The sensing data of the torque sensor can also be used to determine the radial orientation of the distal end of the catheter body. Please refer to the following for details, which will not be elaborated here.

[0062] In the positioning device 9 provided by the embodiment of the present invention, the positioning unit 8 can locate the three-dimensional position of the catheter in the target object during surgery through a magnetic field and / or an electric field.

[0063] Better, such as Figure 6 As shown, the positioning device 9 provided in the embodiment of the present invention further includes a positioning display unit 7, which is used to display a positioning simulation image of the catheter body in the target object, so that the operator can observe the status of the catheter body in the target object in real time.

[0064] In addition, in this embodiment, the positioning display unit 7 preferably has an interactive interface for the operator to select the catheter type of the medical catheter 10. The positioning simulation image can also be displayed through the interactive interface. For example, the interactive interface can have multiple windows, including a catheter type selection window and an image display window. The signal processing unit 6 is further configured to call pre-stored corresponding catheter attribute parameters based on the catheter type selected by the operator on the positioning display unit 7. That is, in this embodiment of the present invention, the catheter type of the catheter is selected by the operator.

[0065] In other embodiments, a catheter identification unit may also be provided. After the medical catheter 10 is connected, the unit is configured to automatically identify the catheter type of the medical catheter 10 and generate catheter attribute parameters for reference by the signal processing unit 6. However, the additional provision of this catheter identification unit increases hardware costs. Therefore, in this embodiment, the positioning display unit 7 is preferably designed with an interactive interface that allows the operator to directly select the catheter type. Furthermore, the positioning display unit 7 is preferably configured to mark the bending direction of the distal end of the catheter body on the displayed positioning simulation image based on the determination result of the positioning unit 8, for easy confirmation by the operator.

[0066] In the embodiment of the present invention, the catheter attribute parameters may include length L, radius r, stiffness coefficient G and mass M. The signal processing unit 6 determines the algorithm formula according to the called catheter attribute parameters. In an exemplary embodiment, Figure 7 As shown, the algorithm formula is, for example: Among them, the rotational inertia J of the catheter, the damping coefficient C of the catheter in the blood vessel (built-in as a fixed value according to experimental parameters) and the elastic coefficient k of the catheter (for example, in one case in is the cross-sectional polar moment of inertia of the catheter) is a constant, and is calculated by retrieving the catheter attribute parameters according to the catheter type. T represents the torque value (if high accuracy is not required, the T value can also be used as 0 in the calculation). As mentioned above, the torque value can be measured by setting a torsion sensor at the connection between the main section 2 and the handle 1 of the medical catheter. In other embodiments, the T value can also be measured by other methods, which will not be repeated here. represents the movement speed (including magnitude and direction) of the housing 12 measured by the second integrated circuit chip 18, represents the acceleration (including magnitude and direction) of the housing 12 measured by the second integrated circuit chip 18, from which Δθ can be calculated according to the above calculation formula, where Δθ is the radial direction of the catheter end toward θ tip With the catheter handle end radially toward θ handle The difference in the radial direction of the catheter handle end is θ handle When the radial direction of the catheter end is known, the tip .

[0067] In the positioning device 9 provided in an embodiment of the present invention, the positioning unit 8, the signal processing unit 6, and the positioning display unit 7 can be implemented in a single device, or any of these units can be split into multiple sub-functional units. Alternatively, at least part of the functions of one or more of the positioning unit 8, the signal processing unit 6, and the positioning display unit 7 can be combined with at least part of the functions of other units and implemented in a single functional unit. For example, in an alternative embodiment, the signal processing unit 6 in the positioning device 9 provided in an embodiment of the present invention can be disposed outside the medical catheter 10, or the signal processing unit 6 can be disposed in the handle 1 of the medical catheter. After the first integrated circuit chip 17 and the second current collection circuit chip 18 transmit their respective sensing data to the signal processing unit 6, the signal processing unit 6 then transmits the processing results to the positioning unit 8 outside the medical catheter 10. In this case, the signal processing unit 6 can also be considered part of the medical catheter 10. In another alternative embodiment, the signal processing unit 6 is disposed outside the medical catheter 10, and the sensing data of the first integrated circuit chip 17 and the second current collection circuit chip 18 are processed outside the medical catheter 10.

[0068] Regarding the catheter system, when the distal electrode segment 4 of the medical catheter 10 is equipped with a radio frequency electrode, the catheter system may further include a radio frequency generator 5, the radio frequency transmitter being used to transmit radio frequency signals to the radio frequency electrode. When the distal electrode segment 4 of the medical catheter 10 is equipped with a blood pressure sensor, the catheter system may further include a blood pressure monitoring device for monitoring the blood pressure level of the blood pressure sensor. When the distal electrode segment 4 of the medical catheter 10 is equipped with both a radio frequency electrode and a blood pressure sensor, the catheter system may include both the radio frequency generator 5 and the blood pressure monitoring device. In other words, the structure of the catheter system can be adjusted based on the type of electrode segment 4 of the medical catheter 10. While the remaining structural features of the medical catheter 10 are not described in detail in the embodiments of the present invention, it is understood that the medical catheter 10 in the embodiments of the present invention includes some structural features of conventional catheters, such as a push rod, a saline delivery tube for delivering saline, and a pull wire for adjusting the bend of the bendable segment 3.

[0069] Figure 8 The workflow of the catheter system using the embodiment of the present invention is described, including the following steps:

[0070] S10, reading the radial orientation of the catheter handle housing;

[0071] S11, reading the motion state (movement direction, speed and acceleration) of the catheter handle housing;

[0072] S12, after the operator selects a catheter to be used for surgery, calling the catheter attribute parameters of the selected catheter;

[0073] S20, calculating the radial orientation of the catheter tip based on the radial orientation and motion state of the catheter handle housing and the catheter attribute parameters;

[0074] S21, read the three-dimensional position of the catheter tip;

[0075] S30, combining the three-dimensional position and radial orientation of the catheter end to determine the bending direction of the catheter at that position;

[0076] S40: Mark the bending direction of the distal end of the catheter on the real-time positioning simulation image of the catheter.

[0077] Among them, the execution order of steps S10, S11, and S12 is not particular, and the execution order of S20 and S21 is not particular.

[0078] Steps S10 and S11 are implemented by the first integrated circuit chip 17 and the second integrated circuit chip 18, respectively. In step S20, the selection of the catheter type is implemented by the operator operating the interactive interface of the positioning display unit 7, that is, the operator can manually select the catheter to be used for the operation in the positioning display unit 7 before starting the surgical operation, and then call the catheter attribute parameters according to the selected catheter type through the signal processing unit 6. Step S20 is implemented by the signal processing unit 6. Steps S21 and S30 are implemented by the positioning unit 8, and step S40 is implemented by the positioning display unit 7. Of course, as in the aforementioned embodiment, step S11 can also include sensing the torque value of the catheter body affected by the connected handle, and step 20 can also be to calculate the radial orientation of the catheter tip in combination with the radial orientation and movement state of the catheter handle shell, the catheter attribute parameters and the torque value of the catheter body affected by the connected handle.

[0079] Figure 9 、 10 The figure shows how the catheter handle 11 controls the bending direction of the catheter during two different surgical procedures. Figure 9For example, the bending direction of the catheter in the renal artery 32 (right kidney 31, please note that the right kidney is displayed on the left due to image mirroring) is marked as 30, and is displayed in real time in the three-dimensional model through the positioning display unit 7. The initial bending direction of the catheter is to the right (the initial bending direction of the catheter is determined by the position of the distal end of the catheter relative to the handle 1 when the catheter is installed. The positioning device 9 can display the bending direction of the distal end of the catheter in real time through the gravity and angle parameters of the catheter handle 1 and the correspondence between the catheter handle 1 and the bending direction of the catheter). The catheter is controlled to rotate 180° counterclockwise to make the catheter bend to the left. After confirming that the catheter bending direction 30 marked by the positioning display unit 7 is consistent with the target bending direction, the push rod 29 is activated to make the distal end of the catheter enter the right renal artery (target). Similarly, if Figure 10 As shown, after the catheter has undergone one bend, its initial bend direction is downward. The catheter is then controlled to rotate counterclockwise 180° so that the bend direction is upward. After confirming that the catheter bend direction 30 marked on the positioning display unit 7 is consistent with the target direction, the push rod 29 is activated to place the catheter electrode segment 4 in contact with the upper wall of the right renal artery.

[0080] In summary, the present invention provides a medical catheter, positioning device, and catheter system. The catheter system includes the medical catheter and the positioning device. An integrated circuit module is installed within the handle housing of the medical catheter. The integrated circuit module is used to sense the radial orientation and motion state of the handle housing and transmit the sensing results to the positioning device. The positioning device determines the bending direction of the distal end of the medical catheter based on the three-dimensional position of the distal end of the medical catheter, the catheter attribute parameters of the medical catheter, and the sensing results transmitted by the medical catheter. Using the medical catheter, positioning device, and catheter system provided by the present invention, an operator can obtain real-time feedback on the rotation of the catheter around different axial directions based on the bending direction of the distal end of the catheter, thereby reducing unnecessary operations (such as test excitation) during surgery, thereby reducing surgical time and surgical risks.

[0081] Furthermore, it should be recognized that although the present invention has been disclosed above with reference to preferred embodiments, the above embodiments are not intended to limit the present invention. Any person skilled in the art can utilize the above disclosed technical content to make many possible changes and modifications to the technical solution of the present invention without departing from the scope of the technical solution of the present invention, or modify the technical solution of the present invention into equivalent embodiments with equivalent changes. Therefore, any simple modifications, equivalent changes, and modifications made to the above embodiments based on the technical essence of the present invention without departing from the content of the technical solution of the present invention shall still fall within the scope of protection of the technical solution of the present invention.

Claims

1. A medical catheter, characterized in that: include: A catheter body and a handle, wherein the handle is connected to the proximal end of the catheter body, wherein The handle includes a housing and an integrated circuit module disposed within the housing, the integrated circuit module including a first integrated circuit chip and a second integrated circuit chip, the first integrated circuit chip being configured to sense a radial orientation of the housing to obtain a first sensing result, and the second integrated circuit chip being configured to sense a motion state of the housing to obtain a second sensing result, the first sensing result and the second sensing result being used to determine the radial orientation of the distal end of the catheter body in combination with catheter attribute parameters of the medical catheter; The catheter property parameters include length L, radius r, rigidity coefficient G and mass M. The radial direction of the catheter body end is determined by the formula Calculation, J represents the moment of inertia of the catheter, C represents the damping coefficient of the catheter in the blood vessel, k represents the elastic coefficient of the catheter, J, C, k are all constants, T represents the torque value, represents the movement speed of the housing measured by the second integrated circuit chip, represents the acceleration of the housing measured by the second integrated circuit chip, and Δθ is the acceleration of the catheter end radially toward θ tip With the catheter handle end radially toward θ handle The difference.

2. The medical catheter according to claim 1, wherein The integrated circuit module also includes a fixing member having two mounting grooves, the first integrated circuit chip and the second integrated circuit chip are respectively accommodated in the two mounting grooves, and the upper surfaces of the first integrated circuit chip and the second integrated circuit chip do not exceed the outermost outer surface of the fixing member.

3. The medical catheter according to claim 2, wherein The fixing member is a hollow cylindrical structural member, and at least a portion of the outer contour of the fixing member matches the inner contour of the handle.

4. The medical catheter according to claim 2 or 3, wherein: The fixing member has a first limiting structure, and the housing has a second limiting structure. The first limiting structure and the second limiting structure are matched and connected to limit the relative position of the fixing member and the housing.

5. The medical catheter according to claim 4, wherein One of the first limiting structure and the second limiting structure is a limiting groove, and the other is a protruding piece.

6. The medical catheter according to claim 1, wherein The medical catheter further includes a torque sensor configured to sense a torque value of the catheter body affected by the connected handle. The torque value is used to combine the catheter property parameters of the medical catheter, the first sensing result, and the second sensing result to obtain the radial orientation of the distal end of the catheter body.

7. The medical catheter according to claim 6, wherein The torque sensor is arranged at the connection between the catheter body and the handle.

8. A positioning device for use with the medical catheter according to any one of claims 1 to 7, characterized in that: The positioning device includes: a signal processing unit and a positioning unit; wherein, The signal processing unit is configured to determine the radial orientation of the distal end of the catheter body according to the first sensing result and the second sensing result fed back by the handle, and the catheter attribute parameters of the medical catheter; The positioning unit is used to locate the three-dimensional position of the distal end of the catheter body, and to determine the bending direction of the distal end of the catheter body according to the three-dimensional position and the radial orientation of the distal end of the catheter body.

9. The positioning device according to claim 8, wherein: The positioning device further includes a positioning display unit for displaying a positioning simulation image of the catheter body in the target object, and for marking the bending direction of the distal end of the catheter body on the displayed positioning simulation image according to a determination result of the positioning unit.

10. The positioning device according to claim 9, wherein The positioning display unit has an interactive interface for an operator to select a catheter type of the medical catheter. The signal processing unit is further configured to call pre-stored corresponding catheter attribute parameters according to the catheter type selected by the operator on the positioning display unit.

11. The positioning device according to claim 8, wherein The signal processing unit is used to determine the radial orientation of the distal end of the catheter body based on the first sensing result and the second sensing result fed back by the handle, catheter property parameters of the medical catheter, and a torque value of the catheter body affected by the connected handle.

12. A catheter system, characterized in that: include: The medical catheter according to any one of claims 1 to 7; and The positioning device according to any one of claims 8 to 11, wherein the positioning device is electrically connected to the integrated circuit module of the medical catheter.

13. The catheter system of claim 12, wherein: The catheter body includes a radio frequency electrode, and the catheter system further includes a radio frequency transmitter. The radio frequency transmitter is used to send a radio frequency signal to the radio frequency electrode.

Images