Medical interventional catheter components, medical interventional catheters and medical interventional systems

Abstract

The application provides a medical interventional catheter component, a medical interventional catheter and a medical interventional system. The medical interventional catheter component comprises a catheter body, a needle assembly, a first position sensor and a second position sensor. The needle assembly is movably arranged along the axial direction of the catheter body. The first position sensor is fixedly arranged on the catheter body. The second position sensor is fixedly arranged on the needle assembly. In this way, the distance between the second position sensor and the first position sensor can be obtained through the positional relationship between the two position sensors, and then the length of the needle assembly extending out of the catheter body in the axial direction can be known. Therefore, the extension length of the needle assembly can be accurately controlled to obtain a better treatment effect.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a medical interventional catheter component, a medical interventional catheter, and a medical interventional system. Background Technology

[0002] Interventional catheters with retractable needles are playing an increasingly important role in interventional procedures, especially in the treatment of heart diseases. Their applications are mainly twofold: 1. Interventional catheters for injecting drugs and biological agents (such as cell cultures, growth factors, and therapeutic drugs); 2. Ablation catheters for ablation using retractable needles. Injection catheters can be used to treat coronary artery disease, while ablation catheters can be used to treat hypertrophic cardiomyopathy, among other conditions.

[0003] Coronary artery disease is a serious illness that easily leads to death. When the coronary arteries are severely blocked, the long-term decrease in blood flow can cause loss of myocardial function. Ischemia causes myocardial cell death, and these dead myocardial cells cannot be replaced or regenerated. Therefore, scarring occurs after the wound heals, and the scarred area cannot contract normally. This inevitably increases the load on other areas of the heart, leading to gradual cardiac degeneration and failure. In existing technologies, some interventional catheters with retractable injection needles have an adjustable bend at the distal end, facilitating smooth access to the treatment area in the heart. When the retractable needle is extended, it is inserted into the target area to inject drugs or biological agents into the myocardium, thereby achieving a therapeutic effect. The proximal end of the handle has a push button to control the needle extension length and a knob to control the extension range.

[0004] Hypertrophic cardiomyopathy reduces the amount of blood the heart pumps throughout the body, eventually leading to heart failure. Furthermore, lesions within the hypertrophic myocardium can cause abnormal electrical conduction, resulting in severe arrhythmias. Ablation has become a popular treatment option in recent years. This type of arrhythmia ablation requires a larger and deeper ablation zone. Methods to increase the size of the ablation zone include increasing the electrode diameter, increasing the contact area between the electrode and the tissue, increasing tissue conductivity, and increasing the direct mechanical penetration of the needle / ablation electrode into the tissue. Needle electrode ablation is the most effective because while traditional ablation zones can be enlarged, the maximum depth is only about 7mm. Needle electrode ablation not only provides sufficient depth, but the conductive fluid injected into the needle cools the electrode and increases tissue conductivity, thereby increasing the ablation power and the size of the ablation zone. In the prior art, some catheters into which ablation needles can be inserted have a handle at the proximal end for controlling the extension and retraction of the needle and another handle for controlling the curvature of the distal end of the catheter. The needle extending from the catheter can be inserted into the myocardium for ablation. Saline is infused into the needle to cool the ablation needle and increase the conductivity of the myocardium, thereby increasing the ablation area of ​​the myocardium. Another path of saline is infused between the outer wall of the needle and the middle of the catheter to flush the gap between the needle and the catheter and prevent thrombus formation.

[0005] Compared to other treatment methods, both of these devices can achieve certain therapeutic effects. However, when controlling the extension of the injection or ablation needle proximally, or when the needle is inserted into the myocardium, the extension length can fluctuate significantly. The needle extension length is one of the important factors affecting the therapeutic effect of injection and ablation needles. If the needle extension length cannot be precisely controlled, the injection or ablation needle cannot reach the target depth, cannot form the required size ablation lesion, and cannot achieve the ideal therapeutic effect. Summary of the Invention

[0006] The purpose of this invention is to provide a medical interventional catheter component, a medical interventional catheter, and a medical interventional system to solve the problem in the prior art that interventional catheters with retractable needles cannot accurately control the needle extension length.

[0007] To solve the above-mentioned technical problems, the present invention provides a medical interventional catheter component, which includes: a catheter body, a needle assembly, a first position sensor and a second position sensor;

[0008] The catheter body has a hollow first inner cavity, the needle assembly is arranged along the axial direction of the catheter body, and the needle assembly is movable along the axial direction of the catheter body between a retracted position and an extended position.

[0009] The first position sensor is fixedly mounted on the catheter body, and the second position sensor is fixedly mounted on the needle assembly; the position information of the first position sensor and the position information of the second position sensor are used to determine the axial distance of the needle assembly relative to the catheter body.

[0010] Optionally, the retracted position is set such that the needle assembly is completely inserted into the first inner cavity; the extended position is set such that the distal end of the needle assembly extends out of the distal end of the first inner cavity.

[0011] Optionally, the position information of the first position sensor and the position information of the second position sensor are used to calculate the spatial straight-line distance between the distal end of the needle assembly and the distal end of the catheter body, and the spatial straight-line distance and the radial distance between the first position sensor and the second position sensor are used to calculate the axial distance between the distal end of the needle assembly and the distal end of the catheter body.

[0012] Optionally, the needle assembly includes a hollow needle and an injection tube, the injection tube being connected to the proximal end of the hollow needle; the second position sensor is fixed to the hollow needle or the injection tube.

[0013] Optionally, the second position sensor is fixedly disposed on the outer wall of the hollow needle and located at the connection between the hollow needle and the injection tube.

[0014] Optionally, the second position sensor and its wire are disposed in the wall of the injection tube.

[0015] Optionally, the needle assembly further includes a temperature sensor, which is fixedly disposed on the outer wall, inner wall, or needle wall of the hollow needle, for sensing the temperature of the hollow needle.

[0016] Optionally, the needle assembly includes a wire protection tube, which is inserted inside the injection tube for the wires of the second position sensor to pass through.

[0017] Optionally, the needle assembly further includes a solid ablation needle and an ablation lead, wherein the solid ablation needle is electrically connected to the ablation lead.

[0018] Optionally, the catheter body includes a guide tube, which is fixedly inserted into the first inner cavity along the axial direction of the catheter body. The guide tube has a second inner cavity for the needle assembly to pass through, and the first position sensor is disposed outside the guide tube.

[0019] To address the aforementioned technical problems, the present invention also provides a medical interventional catheter, which includes a control handle and the medical interventional catheter components as described above; the control handle is connected to the proximal end of the catheter body, and the control handle includes a knob for driving the needle assembly to move.

[0020] To address the aforementioned technical problems, the present invention also provides a medical interventional system, comprising a medical interventional catheter, a magnetic field generator, a reference electrode, and a control device as described above; the first position sensor, the second position sensor, the magnetic field generator, and the reference electrode are respectively communicatively connected to the control device; the first position sensor and the second position sensor are used to sense the magnetic field of the magnetic field generator to obtain a sensing signal; the control device obtains the position information of the first position sensor and the position information of the second position sensor based on the sensing signal and the reference electrode, and determines the axial distance of the needle assembly relative to the catheter body.

[0021] Optionally, the medical interventional system includes: a display device, which is communicatively connected to the control device, and the display device is used to display the axial distance of the distal end of the needle assembly relative to the distal end of the first lumen.

[0022] Optionally, the knob is communicatively connected to the control device; the control device is configured to calculate the axial distance between the distal end of the needle assembly and the distal end of the first inner cavity based on the position information of the first position sensor and the position information of the second position sensor, and control the knob to drive the needle assembly to move according to the comparison result of the calculated axial distance between the distal end of the needle assembly and the distal end of the first inner cavity with a set value, so that the axial distance between the distal end of the needle assembly and the distal end of the first inner cavity is kept within a preset range.

[0023] Optionally, the medical interventional catheter further includes a force sensor disposed on the needle assembly and / or the catheter body, the force sensor being communicatively connected to the control device for sensing the feedback force of the catheter body and / or the needle assembly; the control device is configured to issue a warning signal when the feedback force of the catheter body and / or the needle assembly sensed by the force sensor is greater than a preset threshold.

[0024] In summary, the medical interventional catheter component, medical interventional catheter, and medical interventional system provided by this invention include a catheter body, a needle assembly, a first position sensor, and a second position sensor. The needle assembly is movably disposed along the axial direction of the catheter body. The first position sensor is fixedly disposed on the catheter body, and the second position sensor is fixedly disposed on the needle assembly. With this configuration, the distance between the second position sensor and the first position sensor can be obtained through the positional relationship between the two position sensors, thereby determining the axial extension length of the needle assembly beyond the catheter body. Therefore, better therapeutic effects can be achieved by precisely controlling the extension length of the needle assembly. Attached Figure Description

[0025] Those skilled in the art will understand that the accompanying drawings are provided to better understand the invention and do not constitute any limitation on the scope of the invention. Wherein:

[0026] Figure 1 This is a schematic diagram of the medical interventional catheter component provided in Embodiment 1 of the present invention;

[0027] Figure 2 This is a schematic diagram of the medical interventional catheter provided in Embodiment 1 of the present invention;

[0028] Figure 3 This is a schematic diagram of the use of the medical interventional system provided in Embodiment 1 of the present invention;

[0029] Figure 4 This is a schematic diagram of the needle assembly provided in Embodiment 1 of the present invention;

[0030] Figure 5This is a cross-sectional view of the medical interventional catheter component provided in Embodiment 1 of the present invention;

[0031] Figure 6a and Figure 6b This is a schematic diagram of the telescopic extension of the medical interventional catheter component provided in Embodiment 1 of the present invention;

[0032] Figures 7a-7c This is a schematic diagram of the needle assembly provided in Embodiment 2 of the present invention;

[0033] Figures 8a-8c This is a schematic diagram of the needle assembly provided in Embodiment 3 of the present invention;

[0034] Figure 9 This is a schematic diagram of the needle assembly provided in Embodiment 4 of the present invention;

[0035] Figure 10 This is a schematic diagram of a medical interventional catheter component provided in Embodiment Six of the present invention, wherein the catheter body includes a force sensor;

[0036] Figure 11 This is a schematic diagram of a needle assembly provided in Embodiment Six of the present invention, wherein the needle assembly includes a force sensor.

[0037] In the attached image:

[0038] 1-Medical interventional catheter; 3-Perfusion or injection equipment; 4-Heart; 5-Ablation equipment;

[0039] 10-Catheter body; 11-Guide tube;

[0040] 20-Needle assembly; 21-Hollow needle; 22-Injection tube; 23-Wire protection tube; 24-Temperature sensor; 25-Fixing tube; 31-First position sensor; 32-Second position sensor; 320-Wire of the second position sensor; 36-Force sensor; 40-Control handle; 41-Knob; 42-Electrical connector;

[0041] 51-Magnetic field generator; 52-Reference electrode; 53-Control device; 54-Display device; Detailed Implementation

[0042] To make the objectives, advantages, and features of this invention clearer, the invention will be further 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 facilitate and clarify the explanation of the embodiments of this invention. Furthermore, the structures shown in the drawings are often part of the actual structures. In particular, different figures may emphasize different aspects and may sometimes use different scales.

[0043] As used in this specification, the singular forms “a,” “an,” and “the” include plural objects unless otherwise expressly indicated. As used in this specification, the term “or” is generally used to mean “and / or,” and unless otherwise expressly indicated, the term “proximal” generally refers to the end closer to the operator, and the term “distal” generally refers to the end closer to the lesion near the patient.

[0044] This invention provides a medical interventional catheter component, a medical interventional catheter, and a medical interventional system to solve the problem of inaccurate control of needle extension length in existing interventional catheters with retractable needles. The medical interventional catheter component includes: a catheter body, a needle assembly, a first position sensor, and a second position sensor. The catheter body has a hollow first inner cavity. The needle assembly is arranged axially along the catheter body and is movable axially between a retracted position and an extended position. The first position sensor is fixedly mounted on the catheter body, and the second position sensor is fixedly mounted on the needle assembly. The position information of the first and second position sensors is used to determine the axial distance of the needle assembly relative to the catheter body. With this configuration, the distance between the second and first position sensors can be obtained through the positional relationship between the two position sensors, thus determining the axial extension length of the needle assembly beyond the catheter body. Therefore, better treatment effects can be achieved by precisely controlling the extension length of the needle assembly.

[0045] The following description refers to the accompanying drawings.

[0046] Example 1

[0047] Please refer to Figures 1 to 6b ,in, Figure 1 This is a schematic diagram of the medical interventional catheter component provided in Embodiment 1 of the present invention. Figure 2 This is a schematic diagram of the medical interventional catheter provided in Embodiment 1 of the present invention. Figure 3 This is a schematic diagram of the medical interventional system provided in Embodiment 1 of the present invention. Figure 4 This is a schematic diagram of the needle assembly provided in Embodiment 1 of the present invention. Figure 5 This is a cross-sectional view of the medical interventional catheter component provided in Embodiment 1 of the present invention. Figure 6a and Figure 6b This is a schematic diagram of the extension and retraction of a medical interventional catheter component provided in Embodiment 1 of the present invention.

[0048] As described in the background section, when controlling the extension of the needle assembly at the proximal end of a medical interventional catheter with a retractable needle assembly, or when the needle assembly is inserted into the myocardium, the extension length of the needle assembly fluctuates significantly. The inventors have found the main reasons to be as follows: 1. There is friction between the inner wall of the catheter and the needle assembly, and this friction increases when the catheter is bent; 2. The pusher assembly is relatively long and has limited rigidity, making it impossible to transmit the pushing force from the proximal end to the distal end of the needle assembly in a 1:1 ratio; 3. There is a certain gap between the inner wall of the catheter and the outer wall of the needle assembly, and the extension length of the needle assembly will vary depending on the bending state of the catheter; 4. When the needle assembly is inserted into the tissue, the pusher assembly is subjected to compressive force, which may cause the length of the needle assembly inserted into the myocardium to be less than the length set before insertion. Thus, the needle extension length often cannot be precisely controlled.

[0049] To address this problem, Embodiment 1 of the present invention provides a medical interventional catheter component, such as... Figure 1 As shown, the medical interventional catheter component includes: a catheter body 10, a needle assembly 20, a first position sensor 31, and a second position sensor 32. The catheter body 10 has a hollow first inner cavity. The needle assembly 20 is arranged along the axial direction of the catheter body 10 and is movable along the axial direction of the catheter body 10 between a retracted position and an extended position. Optionally, the retracted position is set such that the needle assembly 20 is completely inserted into the first inner cavity; the extended position is set such that the distal end of the needle assembly 20 extends beyond the distal end of the first inner cavity. The first position sensor 31 is fixedly mounted on the catheter body 10, and the second position sensor 32 is fixedly mounted on the needle assembly 20. The position information of the first position sensor 31 and the position information of the second position sensor 32 are used to determine the axial distance of the needle assembly 20 relative to the catheter body 10. With this configuration, the distance between the second position sensor 32 and the first position sensor 31 can be obtained through the positional relationship between the two position sensors, thereby determining the length of the needle assembly 20 extending axially from the catheter body 10. Therefore, better treatment results can be achieved by precisely controlling the extension length of the needle assembly 20.

[0050] like Figure 2 As shown, Embodiment 1 of the present invention also provides a medical interventional catheter, which includes a control handle 40 and the medical interventional catheter components described above. The control handle 40 is connected to the proximal end of the catheter body 10. The control handle 40 includes a knob 41, which is used to drive the needle assembly 20 to move. Further, the control handle 40 also includes an electrical connector 42, which is connected to a first position sensor 31 and a second position sensor 32 via wires, and is used to establish an electrical connection with an external control device to transmit the signals sensed by the first position sensor 31 and the second position sensor 32.

[0051] refer to Figure 1 and combined Figure 5 In some embodiments, the catheter body 10 includes a guide tube 11, which is fixedly inserted into the first inner cavity along the axial direction of the catheter body 10. The guide tube 11 has a second inner cavity through which the needle assembly 20 passes. Optionally, the first inner cavity of the catheter body 10 is divided into multiple sub-cavities, and the guide tube 11 is fixed in one of these sub-cavities. The needle assembly 20 can move back and forth within the guide tube 11 (i.e., move along the axial direction of the catheter body 10) under the drive of the knob 41. Preferably, as... Figure 4 As shown, the needle assembly 20 includes a hollow needle 21 and an injection tube 22. The injection tube 22 is connected to the proximal end of the hollow needle 21, such as by fitting the injection tube 22 outside the proximal end of the hollow needle 21 to form a fixed connection. The second position sensor 32 is fixed to the hollow needle 21, for example, by fixing the second position sensor 32 in the outer wall, inner wall, or needle wall of the hollow needle 21, the outer wall, inner wall, or tube wall of the injection tube 22. Optionally, in some embodiments, the needle assembly 20 further includes a fixing tube 25, in which the hollow needle 21 and the second position sensor 32 are both inserted and sealed with glue to achieve a fixed connection between the hollow needle 21 and the second position sensor 32. The fixing tube 25 is axially movably inserted into the second inner cavity of the guide tube 11, while the first position sensor 31 is disposed outside the guide tube 11.

[0052] Please refer to Figure 4In one exemplary embodiment of the needle assembly 20, the second position sensor 32 is fixedly disposed on the outer wall of the hollow needle 21 and located at the connection between the hollow needle 21 and the injection tube 22. Optionally, the second position sensor 32 is connected to the proximal control handle 40 via a wire, the wire 320 of which is disposed in the injection tube 22. Since the second position sensor 32 is disposed at the connection between the hollow needle 21 and the injection tube 22, the wire 320 of the second position sensor can be directly inserted into the injection tube 22 from the distal end and extend proximally. In some embodiments, the needle assembly 20 includes a wire protection tube 23, which is disposed within the injection tube 22 for the wire 320 of the second position sensor to pass through. Since injection fluid passes through the injection tube 22, the wire protection tube 23 can be used to protect the wire 320 of the second position sensor from contact with the injection fluid, and the distal end of the wire protection tube 23 can be sealed with adhesive. The second position sensor 32 can preferably be fitted with another protective tube and fixed with glue. Optionally, the first position sensor 31 is fixedly disposed in another sub-cavity of the catheter body 10 and glued to maintain its position relative to the distal end of the catheter body 10. When the needle assembly 20 moves back and forth in the guide tube 11, the second position sensor 32 changes position with the needle electrode 20, thus undergoing axial displacement relative to the first position sensor 31 during the movement of the needle assembly 20. Using the position information of the first position sensor 31 and the second position sensor 32, the axial distance (i.e., needle extension length) of the distal end of the needle assembly 20 relative to the distal end of the first inner cavity can be calculated.

[0053] Please refer to Figure 3 To achieve the sensing of position information of the first position sensor 31 and the second position sensor 32, this embodiment of the invention also provides a medical interventional system, which includes: a medical interventional catheter as described above, a magnetic field generator 51, a reference electrode 52, and a control device 53; the first position sensor 31, the second position sensor 32, the magnetic field generator 51, and the reference electrode 52 are respectively communicatively connected to the control device 53. The first position sensor 31 and the second position sensor 32 are used to sense the magnetic field of the magnetic field generator 51 to obtain a sensing signal. The control device 53 obtains the position information of the first position sensor 31 and the position information of the second position sensor 32 based on the sensing signal and the reference electrode 52, and determines the axial distance of the needle assembly 20 relative to the catheter body 10. Preferably, the medical interventional system further includes a display device 54, which is communicatively connected to the control device 53. The display device 54 is used to display the axial distance of the distal end of the needle assembly relative to the distal end of the first lumen. In one application example, combined with The three-dimensional cardiac electrophysiological mapping system, after sensing the needle extension length using two position sensors of the medical interventional catheter, can also be used by the operator to observe the needle extension length. Specifically, the medical interventional system includes a medical interventional catheter 1, an ablation device 5, and a perfusion or injection device 3. The medical interventional catheter 1 is used to intervene in the human heart 4 to perform ablation or injection treatment. The control device 53 includes a positioning processing unit, a patient interface unit, and a computer workstation. During the operation, a magnetic field generator 51 is located near the patient's heart under the operating table, and the positioning processing unit controls the operation of the magnetic field generator 51. A reference electrode 52 is attached to the patient's back and connected to the patient interface unit. The proximal end of the medical interventional catheter enters the lesion area of ​​the patient's heart through intervention. The first position sensor 31 and the second position sensor 32 can sense the magnetic field of the magnetic field generator 51 and generate a weak current signal. This current signal is transmitted to the positioning processing unit and processed in conjunction with the patient interface unit. The medical interventional catheter is used to inject or ablate at different locations in the heart. The three-dimensional position and orientation information of the tip and needle assembly of the medical interventional catheter, as well as the electrocardiogram signal, are transmitted to the computer workstation. The software constructs a three-dimensional cardiac anatomical model and superimposes electrophysiological information to form an electroanatomical diagram. The three-dimensional image of the interventional catheter needle exit and the needle exit length are displayed on the display device 54.

[0054] Preferably, the position information of the first position sensor 31 and the position information of the second position sensor 32 are used to calculate the spatial linear distance between the distal end of the needle assembly 20 and the distal end of the catheter body 10, and the spatial linear distance and the radial distance between the first position sensor 31 and the second position sensor 32 are used to calculate the axial distance between the distal end of the needle assembly 20 and the distal end of the catheter body 10. The following is combined with... Figure 1 , Figure 5 , Figure 6a and Figure 6b This example illustrates the principle behind calculating the needle length.

[0055] The control device 53 acquires the current signal generated by the magnetic field of the magnetic field generator 51 sensed by the first position sensor 31 and the second position sensor 32, thereby obtaining the spatial coordinates of the two position sensors. The coordinates of the first position sensor 31 are (x1, y1, z1), and the coordinates of the second position sensor 32 are (x2, y2, z2). Therefore, the spatial linear distance L between the two position sensors is:

[0056]

[0057] The control device 53 can calculate the spatial linear distance L in real time using the current signals from the two position sensors. The radial distance L2 between the first position sensor 31 and the second position sensor 32 remains constant during the movement of the needle assembly 20, and can be pre-set in the control device 53. Simultaneously, the spatial linear distance L between the two position sensors also satisfies: Where L1 is the axial distance between the first position sensor 31 and the second position sensor 32, therefore, the axial distance between the first position sensor 31 and the second position sensor 32 Furthermore, in Figure 1 In the example shown, the first position sensor 31 is located near the distal end of the catheter body 10, and the second position sensor 32 is located near the proximal end of the hollow needle 21. Since the hollow needle 21 has a certain length, when the distal end of the needle assembly 20 is flush with the distal end of the catheter body 10, the second position sensor 32 is located relatively near the proximal end of the first position sensor 31. Furthermore, the retraction position is set to the point where the needle assembly 20 is fully retracted to the maximum stroke of the catheter body 10 (i.e., the needle assembly 20 is at its closest point of stroke), at which point the axial distance between the two position sensors is L. 初 Optionally, the distal end of the needle assembly 20 is positioned proximal to the distal end of the catheter body 10 (this state is not shown). When the distal end of the needle assembly 20 is flush with the distal end of the catheter body 10, the axial distance between the two position sensors is L0. It is understood that since the length of the hollow needle 21 is a fixed value, L0 is also a fixed value. Figure 6a As shown. The extension position is set at the maximum stroke point where the needle assembly 20 is fully extended from the catheter body 10 (i.e., the needle assembly 20 is at its farthest point of stroke), at which point the axial distance between the two position sensors is L. max ,like Figure 6b As shown. Therefore, during the process of the needle assembly 20 moving from the retracted position to the extended position (i.e., the needle extension process), the axial distance between the two position sensors changes from L... 初 Decrease to L0, then decrease to 0mm, and then gradually increase from 0mm to L. max .

[0058] Preferably, the control device 53 can determine the relative position of the first position sensor 31 and the second position sensor 32. When it is determined that the second position sensor 32 is near the first position sensor 31, that is, the axial distance between the two position sensors is L... 初 During the process of reducing to 0mm, the needle length L 出针=L0- L1, where L0 is a constant, L1 is obtained according to the above formula (3), and L1 is a variable that changes according to the movement of the needle assembly 20. It can be understood that when it is determined that the second position sensor 32 is relative to the far end 31 of the first position sensor, that is, the distance between the two position sensors increases from 0mm to L. max During the process, the needle length L 出针 =L0+L1.

[0059] Therefore, the calculation of the axial distance (i.e., needle extension length) of the distal end of the needle assembly 20 relative to the distal end of the catheter body 10 is first based on the position information of the first position sensor 31 and the position information of the second position sensor 32 to obtain the spatial linear distance of the distal end of the needle assembly 20 relative to the distal end of the first lumen. Then, the axial distance (i.e., needle extension length) of the distal end of the needle assembly 20 relative to the distal end of the catheter body is calculated based on the spatial linear distance and the radial distance between the first position sensor 31 and the second position sensor 32.

[0060] In some embodiments, reference Figure 3 and Figure 4 The medical interventional catheter is illustrated using an ablation needle catheter and an infusion ablation needle catheter as examples. The hollow needle 21 is configured as an ablation electrode, which is used to insert into the predetermined lesion site and infuse saline solution to the distal end through the injection tube 22. The hollow needle 21 is electrically connected to the ablation lead and is connected to the electrical connector 42 of the proximal control handle 40 through the ablation lead, thereby connecting to the external ablation device.

[0061] The needle assembly 20 is not limited to including a hollow needle 21. In some other embodiments, the needle assembly 20 includes a solid ablation needle (not shown) and an ablation wire, wherein the solid ablation needle is electrically connected to the ablation wire.

[0062] Optionally, the needle assembly 20 further includes a temperature sensor 24, which is fixedly disposed on the outer wall, inner wall, or needle wall of the hollow needle 21, and connected to an electrical connector 42 via a wire, for sensing the temperature of the hollow needle 21. The wire protection tube 23 located in the injection tube 22 is also used for the wires of the temperature sensor 24 and / or the ablation wires to pass through. Of course, the wires of the temperature sensor 24 and / or the ablation wires can also be independently passed outside the wire protection tube 23, or other protective tubes can be used separately. Furthermore, those skilled in the art can, according to existing technology, provide a head electrode and a ring electrode at the distal end of the catheter body 10, which will not be described in detail here. Of course, in other embodiments, the medical interventional needle assembly can also be other types of needle assemblies, such as an injection needle assembly, and the needle in the medical interventional needle assembly can also be a solid ablation needle; this invention does not limit this.

[0063] In summary, by fixing the first position sensor 31 to the catheter body 1 and the second position sensor 32 to the movable needle assembly 20, the fixing method of these two position sensors ensures that, on the one hand, the position sensors can be inserted into the human body and move freely in the magnetic field without being restricted by the magnetic field; on the other hand, the relative motion relationship can be measured, so as to calculate the important needle length.

[0064]

Example 2

[0065] Please refer to Figures 7a-7c This is a schematic diagram of the needle assembly provided in Embodiment 2 of the present invention.

[0066] The medical interventional catheter component, medical interventional catheter, and medical interventional system provided in Embodiment 2 of the present invention are basically the same as those provided in Embodiment 1. The same parts will not be described again, and only the differences will be described below.

[0067] like Figures 7a-7c As shown, unlike Embodiment 1, in this Embodiment 2, the second position sensor 32 is fixed to the injection tube 22. For example, the second position sensor 32 is fixedly disposed on the outer wall of the injection tube 22, the inner wall of the injection tube 22, or in the tube wall of the injection tube 22. Figure 7a This illustrates one embodiment in which the second position sensor 32 is fixedly mounted on the outer wall surface of the injection tube 22. Figure 7b This illustrates one embodiment in which the second position sensor 32 is fixedly disposed on the inner wall surface of the injection tube 22. Figure 7c This illustration shows one embodiment where the second position sensor 32 is fixedly disposed within the wall of the injection tube 22. The second position sensor 32 can be disposed on the surface of the outer or inner wall of the injection tube 22, for example, by using glue injection for fixation. Alternatively, if the second position sensor 32 is disposed within the wall of the injection tube 22, it can be manufactured by molding the second position sensor 32 and the injection tube 22 together.

[0068] Furthermore, the needle assembly 20 includes a lead wire protection tube 23, which passes through the injection tube 22. Optionally, the lead wire protection tube 23 is located near the proximal end of the second position sensor 32, allowing the lead wire 320 of the second position sensor to pass through. This method of installing the sensor lead wire facilitates the protection and installation of the lead wire and is also easy to implement in the process.

[0069]

Example 3

[0070] Please refer to Figures 8a-8c This is a schematic diagram of the needle assembly provided in Embodiment 3 of the present invention.

[0071] The medical interventional catheter component, medical interventional catheter, and medical interventional system provided in Embodiment 3 of the present invention are basically the same as those provided in Embodiment 1. The same parts will not be described again, and only the differences will be described below.

[0072] like Figures 8a-8c As shown, unlike Embodiment 1, in this Embodiment 3, the second position sensor 32 is fixedly disposed on the outer wall, the inner wall, or the wall of the injection tube 22. Specifically, Figure 8a This illustrates one embodiment in which the second position sensor 32 is fixedly mounted on the outer wall surface of the injection tube 22. Figure 8b This illustrates one embodiment in which the second position sensor 32 is fixedly disposed on the inner wall surface of the injection tube 22. Figure 8c This illustration shows one embodiment where the second position sensor 32 is fixedly disposed within the wall of the injection tube 22. Furthermore, the wire 320 of the second position sensor is disposed within the wall of the injection tube 22 and extends proximally. In practice, the injection tube 22 can be composed of a combination of tubing and wire. This method of sensor wire installation saves installation space, allowing full utilization of the internal space of the injection tube 22, providing space for the passage of other wires and liquid, thus facilitating product performance optimization. Specifically, as... Figure 8c In the embodiment shown, there are no protrusions on the inner and outer walls of the injection tube 22 and the inner and outer walls of the hollow needle 21. The needle assembly 20 has low movement resistance and low flow resistance to the injection or perfusion liquid. The lead wire is embedded in the tube wall through a composite structure and will not come into contact with the injection or perfusion liquid, resulting in high reliability.

[0073] Furthermore, when the medical interventional catheter is configured as an ablation needle catheter and an infusion ablation needle catheter, the wires of the temperature sensor and / or the ablation wires can also be compositely formed with the wires 320 of the second position sensor in the wall of the injection tube 22.

[0074]

Example 4

[0075] Please refer to Figure 9 This is a schematic diagram of the needle assembly provided in Embodiment 4 of the present invention.

[0076] The medical interventional catheter component, medical interventional catheter and medical interventional system provided in Embodiment 4 of the present invention are basically the same as those provided in Embodiment 1. The same parts will not be described again. The following only describes the differences.

[0077] like Figure 9As shown, in this fourth embodiment, the second position sensor 32 is fixedly mounted on the inner wall of the hollow needle 21. This method saves installation space at the tip of the second position sensor 32, reducing the overall diameter of the needle assembly 20, and thus reducing the diameter of the entire medical interventional catheter, facilitating interventional procedures. Furthermore, it also helps protect the second position sensor 32 and ensures the implementation of product bending control and other performance characteristics.

[0078] In other embodiments, the second position sensor 32 may also be disposed within the needle wall of the hollow needle 21. For example, the hollow needle 21 may be made of a composite of a polymer material and the second position sensor 32, with the second position sensor 32 placed within the needle wall of the hollow needle 21. Furthermore, when the medical interventional catheter is configured as an ablation needle catheter and an infusion ablation needle catheter, electrodes may be formed on the outer wall of the hollow needle 21 by means of electroplating or other methods.

[0079] Example 5

[0080] The medical interventional catheter component, medical interventional catheter, and medical interventional system provided in Embodiment 5 of the present invention are basically the same as those provided in Embodiment 1. The same parts will not be described again, and only the differences will be described below.

[0081] In the medical interventional system provided in Embodiment 5, the knob 41 is communicatively connected to the control device 53. The control device 53 is configured to calculate the axial distance between the distal end of the needle assembly 20 and the distal end of the first lumen based on the position information of the first position sensor 31 and the position information of the second position sensor 32. Based on a comparison between the calculated axial distance between the distal end of the needle assembly 20 and the distal end of the first lumen and a preset value, the control device 53 controls the knob 41 to drive the needle assembly 20 to move, so that the axial distance between the distal end of the needle assembly 20 and the distal end of the first lumen is maintained within a preset range. Both the preset value and the preset range can be set differently according to actual conditions. The selected preset value should ensure that the needle assembly 20 enters the lesion area at a predetermined depth to achieve a therapeutic effect. The selected preset range should ensure that the needle length of the needle assembly 20 does not fluctuate too much when subjected to reaction forces from human tissue. Preferably, the control device 53 compares the needle extension length of the needle assembly 20 with the set value in real time. If the comparison result of the needle extension length and the set value exceeds the preset range, the control knob 41 is controlled in time to adjust the needle extension length of the needle assembly 20 so that the needle extension length of the needle assembly 20 is kept near the set value.

[0082] Optionally, a drive element is mounted on the knob 41, and the control device 53 can drive the knob 41 through the drive element to adjust the needle length of the needle assembly 20. Those skilled in the art can make appropriate selections of the drive element according to existing technology.

[0083] Example 6

[0084] Please refer to Figure 10 and Figure 11 ,in, Figure 10 This is a schematic diagram of a medical interventional catheter component provided in Embodiment Six of the present invention, wherein the catheter body includes a force sensor. Figure 11 This is a schematic diagram of a needle assembly provided in Embodiment Six of the present invention, wherein the needle assembly includes a force sensor.

[0085] The medical interventional catheter component, medical interventional catheter, and medical interventional system provided in Embodiment Six of the present invention are basically the same as those provided in Embodiment One. The same parts will not be described again, and only the differences will be described below.

[0086] The medical interventional catheter 1 further includes a force sensor 36 disposed on the needle assembly 20 and / or the catheter body 10. The force sensor 36 is communicatively connected to the control device 53 and is used to sense the feedback force of the catheter body 10 and / or the needle assembly 20. The control device 53 is configured to issue a warning signal when the feedback force of the catheter body 10 and / or the needle assembly 20 sensed by the force sensor 36 is greater than a preset threshold.

[0087] Figure 10 An exemplary embodiment is shown in which the distal end of the medical interventional catheter 1 includes a force sensor 36 disposed within the catheter body 10, preferably located inside the head electrode or between the head electrode and the distal end of the catheter body 10. Preferably, the force sensor 36 may be a ring-shaped or other shaped structure with a pressure strain gauge, or it may be made of a pressure-sensitive element or a photoelectric element. When the needle assembly 20 is inserted into a predetermined tissue and reaches a predetermined depth, the feedback force of the catheter body 10 sensed by the force sensor 36 is within a preset threshold. If the insertion force continues to be applied, the distal end of the catheter body 10 is subjected to a feedback force from the tissue surface (such as...). Figure 10 As indicated by the middle arrow, when the feedback force exceeds the preset threshold and reaches the danger limit, the control device 53 will issue a warning signal, such as triggering a workstation alarm, to prompt the operator to stop applying insertion force to the catheter body 10, thereby avoiding the distal end of the catheter body 10 from penetrating into the tissue due to excessive force, which could cause adverse consequences such as myocardial perforation.

[0088] Figure 11Another exemplary embodiment is shown, in which the distal end of the medical interventional catheter 1 includes a force sensor 36 disposed on the needle assembly 20, preferably located on the inner surface, outer surface, or wall of the hollow needle 21, or on the inner surface, outer surface, or wall of the injection tube 22. Preferably, the force sensor 36 may be a ring-shaped or other shaped structure with a pressure strain gauge, or it may be made of a pressure-sensitive element or a photoelectric element. When the needle assembly 20 is inserted into a predetermined tissue (such as myocardium), the feedback force sensed by the force sensor 36 should be within a preset threshold. If the feedback force sensed by the force sensor 36 is too large, exceeding the preset threshold, it indicates that the needle assembly 20 may have punctured the wrong location (such as a valve, tendon, or other tissue). This would not only fail to achieve the therapeutic effect but would also worsen the patient's condition. During the procedure, the operator can determine whether the needle has been inserted into the myocardium that should be treated by monitoring the magnitude of the feedback force sensed by the force sensor 36.

[0089] It should be noted that the various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. Similar or identical parts between embodiments can be referred to interchangeably. Furthermore, the different parts between embodiments can be combined, and this invention does not limit this. For example, the second position sensor 32 can be fixed to the outer wall of the hollow needle 21 using the method described in Embodiment 1, while the wires of the second position sensor 32 can be placed in the wall of the injection tube 22 using the method described in Embodiment 3. Those skilled in the art can make different combinations based on the above description.

[0090] The above description is merely a description of preferred embodiments of the present invention and is not intended to limit the scope of the present invention in any way. Any changes or modifications made by those skilled in the art based on the above disclosure shall fall within the protection scope of the claims.

Claims

1. A medical interventional catheter component, characterized by Comprising: a catheter body, a needle assembly, a first position sensor and a second position sensor; the catheter body has a hollow first inner cavity, the needle assembly is arranged along the axial direction of the catheter body, and the needle assembly can move along the axial direction of the catheter body between a retracted position and an extended position; the first position sensor is fixedly arranged on the catheter body, and the second position sensor is fixedly arranged on the needle assembly; wherein the first position sensor and the second position sensor are used to induct the magnetic field of a magnetic field generator to obtain an inductive signal, and the inductive signal is configured to obtain the position information of the first position sensor and the position information of the second position sensor in combination with a reference electrode; the position information of the first position sensor and the position information of the second position sensor are used to judge the axial distance of the movement of the needle assembly relative to the catheter body; the position information of the first position sensor and the position information of the second position sensor are used to calculate the spatial straight-line distance of the distal end of the needle assembly relative to the distal end of the catheter body in real time, and the spatial straight-line distance and the radial distance between the first position sensor and the second position sensor are used to calculate the axial distance of the distal end of the needle assembly relative to the distal end of the catheter body.

2. The medical intervention catheter component of claim 1, wherein, The retracted position is set as the needle assembly is completely arranged in the first inner cavity; the extended position is set as the distal end of the needle assembly extends out of the distal end of the first inner cavity.

3. The medical intervention catheter component of claim 1, wherein, The needle assembly comprises a hollow needle and a syringe tube, the syringe tube is connected to the proximal end of the hollow needle; the second position sensor is fixed with the hollow needle or the syringe tube.

4. The medical intervention catheter component of claim 3, wherein, The second position sensor is fixedly arranged on the outer wall of the hollow needle at the connection between the hollow needle and the syringe tube.

5. The medical intervention catheter component of claim 3, wherein, The second position sensor and the lead wire of the second position sensor are arranged in the tube wall of the syringe tube.

6. The medical intervention catheter component of claim 3, wherein, The needle assembly further comprises a temperature sensor, which is fixedly arranged in the outer wall of the hollow needle, the inner wall of the hollow needle or the needle wall of the hollow needle, and is used to sense the temperature of the hollow needle.

7. The medical intervention catheter component of claim 3, wherein, The needle assembly further comprises a lead wire protection tube, which is arranged in the syringe tube, and is used for the lead wire of the second position sensor to pass through.

8. The medical intervention catheter component of claim 1, wherein, The needle assembly further comprises a solid ablation needle and an ablation lead wire, and the solid ablation needle is electrically connected with the ablation lead wire.

9. The medical intervention catheter component of claim 1, wherein, The catheter body comprises a guide tube, which is fixedly arranged in the first inner cavity along the axial direction of the catheter body, and has a second inner cavity for the needle assembly to pass through; the first position sensor is arranged outside the guide tube.

10. A medical intervention catheter, characterized by Comprising: a control handle and the medical interventional catheter part according to any one of claims 1-9; the control handle is connected with the proximal end of the catheter body, and the control handle comprises a knob for driving the movement of the needle assembly.

11. A medical intervention system, characterized by Comprising: The medical intervention catheter, the magnetic field generator, the reference electrode and the control device according to claim 10; the first position sensor, the second position sensor, the magnetic field generator and the reference electrode are respectively connected in communication with the control device, the first position sensor and the second position sensor are used to induce the magnetic field of the magnetic field generator to obtain an induction signal, the control device obtains position information of the first position sensor and position information of the second position sensor based on the induction signal and the reference electrode, and judges an axial distance of the needle assembly relative to the catheter body movement.

12. The medical intervention system of claim 11, characterized in that Comprising: a display device connected in communication with the control device, the display device being used to display an axial distance of a distal end of the needle assembly relative to a distal end of the first inner cavity.

13. The medical interventional system of claim 11, wherein, The knob is connected in communication with the control device; the control device is configured to calculate an axial distance of a distal end of the needle assembly relative to a distal end of the first inner cavity based on the position information of the first position sensor and the position information of the second position sensor, and to control the knob to drive the needle assembly to move according to a comparison result of the calculated axial distance of the distal end of the needle assembly relative to the distal end of the first inner cavity with a set value, so as to keep the axial distance of the distal end of the needle assembly relative to the distal end of the first inner cavity within a preset range.

14. The medical interventional system of claim 11, wherein, The medical intervention catheter further comprises a force sensor arranged on the needle assembly and / or the catheter body, the force sensor being connected in communication with the control device and being used to sense a feedback force of the catheter body and / or the needle assembly; The control device is configured to issue a warning signal when the feedback force of the catheter body and / or the needle assembly sensed by the force sensor is greater than a preset threshold value.

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