Shape-shifting catheter and methods of use

Abstract

The application discloses a morphologically variable catheter and a use method, and belongs to medical instruments, and comprises a head end, an upper arm, a branch arm, an electrode, a lower arm, a proximal tube body and a traction component. The upper arm, the branch arm and the lower arm form a grid-shaped structure through a Y-shaped structure, and the structure can be transformed between a natural state and an unfolded state through the traction component. When the structure is naturally close, the structure is olive-shaped, when the structure is unfolded under stress, the structure is spherical, and when the structure is unfolded to a final state, the structure is petal-shaped. The catheter can increase the supporting and restraining effects of the branch arm, maintain the supporting stability, ensure that the electrode is well attached to the cavity tissue, is suitable for cavity tissues with different diameters and shapes, prevents the electrodes from being overlapped, ensures the safety and effectiveness of energy release, avoids irreversible damage to non-lesion tissues, and the multiple electrodes distributed on the branch arm can improve the accuracy of mapping. Different mapping and ablation modes are formed through different electrode combinations, and the catheter has high practicability.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of catheter medical devices, in particular to a catheter with variable shape and a use method thereof. BACKGROUND

[0002] In catheter intervention therapy, the electrode of the catheter is attached to the target tissue, and then radio frequency energy or high-voltage pulse energy is released between the electrode and the back electrode plate or the electrode to form a loop, and the Joule heat generated by the ion conduction current in the biological tissue and the heat generated by the dielectric loss of the biological tissue in the high-frequency electromagnetic field make the temperature of the lesion tissue rise, because the target tissue is poor in heat dissipation and sensitive to high heat, so as to achieve the purpose of treatment.

[0003] At present, the catheter commonly used for lumen tissue ablation is prone to the risk of electrode overlap or insufficient attachment. Electrode overlap may cause damage to non-lesion tissue; insufficient attachment will affect the ablation efficiency and ablation effect. In addition, the catheter used for lumen tissue ablation also has the problem that different sizes of lumen tissue need to use different specifications of electrodes, such a catheter does not have universality and will bring great burden to doctors, so a catheter that can fully attach and avoid overlap and whose electrode size can be adjusted is needed. In addition, because inaccurate mapping results can cause irreversible ablation damage to other healthy tissues, accurate positioning of the lesion site is required before ablation to avoid unnecessary harm to the patient during ablation, so the designed catheter should be able to accurately map, especially in non-circular isolated ablation of lumen tissue. Overall, the catheter of the prior art has the following problems:

[0004] 1. The catheter commonly used for lumen tissue ablation cannot attach to the tissue well, thereby affecting the ablation efficiency and effect; and there is electrode overlap, causing damage to non-lesion tissue.

[0005] 2. Different sizes of lumen tissue require different specifications of electrodes, increasing the difficulty and time of the operation, and increasing the operation cost of the patient.

[0006] 3. Inaccurate mapping can cause irreversible ablation damage to non-lesion sites, especially in non-circular isolated ablation of lumen tissue. SUMMARY

[0007] The purpose of the present application is to overcome the above-mentioned deficiencies of the catheter in the prior art, provide a catheter with variable shape and a use method thereof, which can maintain stable support and ensure that the electrode is well attached to the tissue, and the catheter can be applied to lumen tissue of different diameters and shapes, and has strong applicability.

[0008] In order to achieve the above-mentioned application purpose, the present application provides the following technical solutions:

[0009] A morphologically variable catheter, comprising a head end, an electrode, a proximal tube body, and a traction member connecting the head end and the proximal tube body, further comprising upper arms, branch arms, and lower arms, the upper arms and the lower arms each have a Y-shaped structure comprising a main branch and two sub-branches, the head end is connected to the main branches of at least two upper arms, the proximal tube body is connected to the main branches of at least two lower arms, the branch arms are connected to the sub-branches of the upper arms and the lower arms at two ends respectively, the adjacent sub-branches of two adjacent lower arms are connected to the two sub-branches of the same upper arm through the branch arms respectively, and the adjacent sub-branches of two adjacent upper arms are connected to the two sub-branches of the same lower arm through the branch arms respectively, so that the sub-branches of the upper arms and the sub-branches of the lower arms are connected in staggered mode through the branch arms, and the electrode is sleeved on the branch arms.

[0010] The head end, the electrode, and the proximal tube body move through the traction of the traction member, so that the plurality of Y-shaped structures and the branch arms of the catheter can be unfolded to form a grid-shaped three-dimensional spherical shape, and the structure has good supportability, so that the catheter can be well attached to the cavity tissue; and when subjected to external pressure, the structure can also keep the catheter in the original state, prevent the electrodes from being overlapped, and avoid the misjudgment of the lesion by the doctor, thereby preventing the damage to the non-lesion tissue.

[0011] In the preferred embodiment of the present application, when the catheter is in a natural state, the upper arms, the branch arms, and the lower arms are close to each other to form an olive shape, and when the head end and the proximal tube body are close to each other, the upper arms, the branch arms, and the lower arms are unfolded to form a spherical shape, and then the upper arms, the branch arms, and the lower arms are unfolded to form a petal shape; through the close and unfolding of the upper arms, the branch arms, and the lower arms, the spherical pipeline can enter and pass through in a smaller cavity tissue, which is conducive to the formation of pre-attachment and contact in the cavity tissue, and the diameter of the spherical pipeline can be changed in a larger cavity tissue, so that the catheter is suitable for different sizes of cavity tissues and forms stable attachment for ablation.

[0012] In the preferred embodiment of the present application, the upper arms, the branch arms, and the lower arms are internally provided with elastic members, the elastic members are wrapped outside the wires or arranged inside the wires, and the elastic members are in the form of wire, sheet, or tube to serve as a framework for support; further, the elastic members are composite materials with shape memory function; further, the elastic material comprises nickel-titanium alloy, nickel-titanium-palladium alloy, and shape memory polymer; through the elastic members, certain tension, elastic force, and torque are provided, so that the elastic members can serve as a framework for support and provide the required level of support and rigidity for the upper arms, the branch arms, and the lower arms.

[0013] In the preferred embodiment of the present application, at least one electrode is arranged on each of the above-mentioned arms, the electrodes at the same corresponding positions on different arms are arranged on the same circle, and there are at least one circle, the radius of the circle increases after the upper arm and the lower arm are unfolded, the axis of the traction member has an included angle with the plane of the electrodes on the circle, and the included angle ranges from 80° to 90°; further, the traction member is coaxially arranged with the head end and the proximal tube, that is, the three are located on the same axis, and the traction member is perpendicular to the plane on which the plurality of electrodes are located, so that the electrodes can be synchronously contracted or unfolded, and can be well supported on the inner wall of the cavity tissue, and the plurality of electrodes can be used to ablate the tissue.

[0014] In the preferred embodiment of the present application, the electrodes include ring electrodes, shuttle-shaped electrodes, flat electrodes, rod-shaped electrodes or special-shaped electrodes, the length of the electrodes ranges from 0.5 mm to 30.0 mm, and the outer diameter ranges from 0.5 mm to 30.0 mm; the size of the electrodes can be set according to different uses, and different sizes of cavity tissues can be adapted.

[0015] In the preferred embodiment of the present application, all the upper arms, the arms and the lower arms are arranged around the traction member, the main branches of all the upper arms are arranged around the axis of the head end, and the main branches of all the lower arms are arranged around the axis of the proximal tube; a symmetrical structure is formed, so that the upper arms, the arms and the lower arms can diverge when unfolded, and balanced and stable support in the cavity tissue is formed.

[0016] In the preferred embodiment of the present application, during the approach of the head end and the proximal tube, the catheter changes from a natural state to a fully unfolded state, and then to a petal state, and all the electrodes change from being distributed along the direction of the traction member to being distributed along the radial direction of the traction member, and then to being distributed on a plane; the electrodes can be adjusted according to the state change of the catheter, and different positions of the cavity tissue are provided by the change of the position and distribution of the electrodes.

[0017] In the preferred embodiment of the present application, the head end is provided with a head end electrode and a first magnetic positioning sensor, and the proximal tube is provided with a proximal electrode and a second magnetic positioning sensor, which are used to determine the position of the catheter; the position of the three-dimensional electric field display can be corrected by using electric field positioning combined with magnetic field, so that the electrode position relationship can be accurately determined, and the electrodes can be accurately displayed.

[0018] A use method of a shape-variable catheter, using the shape-variable catheter described above, comprising the following steps:

[0019] S1, the catheter in a natural state is inserted into the cavity tissue;

[0020] S2, by pulling the head end through the traction member, the upper arm, the branch and the lower arm are unfolded or close, the radial dimension of the catheter is enlarged or reduced, all the electrodes and the branch form a circumferential support on the inner wall of the cavity tissue, and the circumferential support matches the cavity tissue of different sizes;

[0021] S3, the electrode is used to stimulate the cavity tissue, the position of the lesion tissue is confirmed, and if ablation is needed, the electrode is discharged to ablate the lesion tissue.

[0022] The use of the catheter can adjust the shape of the catheter according to the inner diameter of the cavity tissue, when the inner diameter of the cavity tissue is small, the catheter in the natural state is used to abut against the cavity tissue, when the inner diameter of the cavity tissue is large, the diameter of the catheter is increased, so that the catheter abuts against the cavity tissue; the catheter can be stably unfolded, so that the electrodes stably abut against the tissue, the electrodes are prevented from being overlapped, the position of the lesion tissue is found through the electrode stimulation, and ablation is performed through the electrode discharge.

[0023] In the preferred embodiment of the present application, the electrode stimulation or discharge mode in the above step S3 includes three modes:

[0024] At least two electrodes on all the branch arms are used as a whole discharge end to stimulate or discharge, the at least two electrodes refer to two or more electrodes as the discharge end, but all the electrodes are excluded; all the electrodes on all the branch arms are stimulated or discharged; at least one electrode is used to stimulate or discharge the back electrode plate; further, the electrode stimulation is performed by using low-frequency energy or high-frequency energy, and the electrode discharge is performed by using radio frequency energy or high-voltage pulse energy.

[0025] Through the three stimulation or discharge modes, different technical effects are achieved, the lesion position is accurately found through the precise stimulation between the electrodes, the local tissue superficial ablation is achieved through the discharge between the electrodes, and the damage area is small; the annular ablation isolation belt is formed through the discharge of all the electrodes, the annular superficial ablation is achieved, and the deep ablation is achieved through the discharge between the electrode and the back electrode plate.

[0026] Compared with the prior art, the present application has the following beneficial effects:

[0027] 1. The branch arms are connected with the Y-shaped structure to form a staggered connection structure, a grid-shaped spherical structure is formed, the support and restraint effects are achieved, the catheter can stably maintain the shape, and the catheter can be well abutted against the inner wall of the cavity tissue.

[0028] 2. The unfolded state of the upper arm, the branch arm and the lower arm can effectively avoid the problem that the electrodes are overlapped due to external force, the energy is smoothly released and the safety is ensured, and the healthy human tissue is not damaged.

[0029] 3. By traction, the upper arm, the branch arm and the lower arm can be changed from an olive shape to a spherical or petal shape, suitable for different diameter and shape of cavity tissues, and has strong applicability.

[0030] 4. By combination of multiple electrodes, different mapping and ablation methods are formed, and multiple stimulation and discharge ablation modes are provided to adapt to the search and treatment of different lesion sites.

[0031] 5. By discharging the electrodes of the catheter to the cavity tissue, the local tissue and the tissue in the ring area are ablated, and different discharge modes can realize local ablation, accurate ablation and ring ablation of the lesion tissue position.

[0032] 6. By discharging between the electrodes of the catheter and between the electrodes and the back electrode plate, the lesion tissue can be superficially ablated and deeply ablated to achieve different ablation effects. BRIEF DESCRIPTION OF DRAWINGS

[0033] Figure 1 The schematic diagram of the shape-variable catheter of the present application embodiment 1 in a natural state is shown in the figure.

[0034] Figure 2 The schematic diagram of the shape-variable catheter of the present application is shown in the figure.

[0035] Figure 3 The schematic diagram of the shape-variable catheter of the present application is shown in the figure.

[0036] Figure 4 The schematic diagram of the shape-variable catheter of the present application embodiment 1 is shown in the figure.

[0037] Figure 5 The schematic diagram of the shape-variable catheter of the present application embodiment 1 in an expanded state is shown in the figure.

[0038] Figure 6 The schematic diagram of the shape-variable catheter of the present application embodiment 1 in a petal state is shown in the figure.

[0039] Figure 7 The schematic diagram of the shape-variable catheter of the present application embodiment 1 in a vascular tissue is shown in the figure.

[0040] Figure 8 The schematic diagram of the shape-variable catheter of the present application embodiment 1 in a pulmonary vein is shown in the figure.

[0041] Figure 9 The schematic diagram of the shape-variable catheter of the present application embodiment 2 is shown in the figure. Figure 1

[0042] Figure 10 The schematic diagram of the shape-variable catheter of the present application embodiment 2 is shown in the figure. Figure 2 ​​

[0043] Figure 11 For the present invention Figure 9 cross-sectional view of the first electrode plane;

[0044] Figure 12 The method for using the catheter of the embodiments 3 and 4 of the present invention.

[0045] The figure is marked: 1 - head; 2 - proximal tube body; 3 - electrode; 4 - upper arm; 5 - lower arm; 6 - traction member; 7 - branch arm; 8 - axis; 9 - pulmonary vein vestibule; 10 - first magnetic positioning sensor; 11 - second magnetic positioning sensor; 12 - head electrode; 13 - proximal electrode; 14 - vascular tissue; 55 - hollow channel; 66 - first electrode plane; 77 - second electrode plane. DETAILED DESCRIPTION

[0046] The present invention will be further described in conjunction with test examples and specific embodiments. However, this should not be understood as limiting the scope of the above-mentioned subject matter of the present invention to the following examples only, and any technology realized based on the content of the present invention falls within the scope of the present invention.

[0047] Example 1

[0048] Please refer to Figure 1 The embodiment of the present invention provides a morphologically variable catheter, which comprises a head 1, a proximal tube body 2, an electrode 3, an upper arm 4, a lower arm 5, and a branch arm 7, and a traction member 6 connecting the head 1 and the proximal tube body 2, a plurality of upper arms 4 are connected to the head 1, a plurality of lower arms 5 are connected to the proximal tube body 2, the upper arms 4 and the lower arms 5 are connected through the branch arms 7, the branch arms 7 have a plurality of, at least one electrode 3 is arranged on the branch arm 7, the electrode 3 can adopt a ring electrode, a shuttle-shaped electrode, a rod-shaped electrode, a flat electrode or other special-shaped electrodes, such as Figure 2 and Figure 3 The present embodiment adopts a ring electrode, i.e. a sleeve-shaped electrode 3; through the approximation or unfolding of the upper arms 4, the branch arms 7 and the lower arms 5, the catheter can be in a natural state or an unfolded state, the catheter is olive-shaped in the natural state, the catheter is spherical in the unfolded state, and the catheter is petal-shaped in the final unfolded state; the catheter can increase the support and restraint of the branch arms 7, so that the catheter is more stable and not easy to deform, ensures that the ring electrodes 3 are well attached to the cavity tissue, prevents the ring electrodes 3 from overlapping, and at the same time, through the change of the shape, the catheter can be applied to cavity tissues of different diameters and shapes, and the distribution of the plurality of ring electrodes 3 on the branch arms 7 can improve the accuracy of mapping and avoid irreversible damage to non-disease tissues.

[0049] Please refer to Figure 4The head 1 of the embodiment has a round head structure, and is used for accommodating and fixing the upper arm 4 and the traction member 6. The axial center line of the head 1 is aligned with the axial center line of the traction member 6 and the axial center line of the proximal tube body 2. The head 1, the traction member 6 and the proximal tube body 2 are existing structures. The two ends of the traction member 6 are respectively connected to the end surface of one end of the head 1 and the end surface of one end of the proximal tube body 2. The traction member 6 has a traction guide wire inside. The end of the traction guide wire has a retractable outlet at the end of the head 1. The outlet is a hollow channel 55. The above structure is the traction structure of the existing catheter. The traction member 6 is provided with a core tube. One end of the core tube is connected to the handle at the end of the catheter. The other end of the core tube extends to the head 1. The traction member 6 can be controlled through the handle, so as to realize the extension and retraction of the head 1 relative to the proximal tube body 2, and further adjust the unfolding degree of the upper arm 4, the support arm 7 and the lower arm 5. In the embodiment, the head 1 is provided with a head electrode 12 and a first magnetic positioning sensor 10. The first magnetic positioning sensor 10 is arranged in the annular inside of the head electrode 12, or can be arranged beside the head electrode 12. The proximal tube body 2 is provided with a proximal electrode 13 and a second magnetic positioning sensor 11. The second magnetic positioning sensor 11 is arranged in the annular inside of the proximal electrode 13, or can be arranged beside the proximal electrode 13. The first magnetic positioning sensor 10 and the second magnetic positioning sensor 11 are used for determining the position of the catheter. The position of the three-dimensional electric field display can be corrected by combining the electric field and the magnetic field. The position relationship of the ring electrode 3 can be accurately determined. The shape acquisition and display of the catheter are more accurate. The head 1 is connected with the upper arm 4. The proximal tube body 2 is connected with the lower arm 5. The upper arm 4 and the lower arm 5 are connected through the support arm 7. The head 1, the upper arm 4, the support arm 7 and the lower arm 5 are respectively made of a biocompatible flexible material. The flexible material is a heat-insulating and insulating material, including at least one of polyurethane, polyamide, polyimide, polyether-amide block copolymer, polyethylene terephthalate, polypropylene, elastic polyurethane and polyether ether ketone polymer. The embodiment adopts polyamide. The above-mentioned materials make the head 1, the upper arm 4, the support arm 7 and the lower arm 5 form a flexible structure, have the effect of preventing damage, and reduce the harm to the inner wall of the cavity tissue. The head 1 has a round head end, has low hardness, has a smooth surface after forming, is easy to provide the flexibility required by the design, has good heat-insulating and insulating properties, avoids the conduction of heat and electric energy between the parts, and ensures the normal work of the catheter.

[0050] The catheter is positioned by the first magnetic positioning sensor 10 and the second magnetic positioning sensor 11. However, positioning using an electric field is usually inaccurate and can only calculate the relative positional relationship. But by combining the magnetic field, the positional relationship of the ring electrode 3 can be accurately determined. Since there are no positioning sensors near the ring electrodes 3 on the support arm 7, their accurate positional relationship needs to be calculated using an electric field. Theoretically, since multiple ring electrodes 3 are evenly or regularly distributed on the support arm 7, after the ring electrodes 3 expand, they will also be evenly divided into 360° or regularly distributed on the annular circumference. This can be calculated using the first magnetic positioning sensor 10 and the second magnetic positioning sensor 11. However, in actual applications, the ring electrodes 3 will be affected by tissue interference and will deform to varying degrees. Therefore, a combination of magnetic field and electric field calculation is adopted. In the array of ring electrodes 3 on the head end electrode 12, the proximal end electrode 13, and the support arm 7, the relative spatial positional relationship of the ring electrodes 3 can be calculated by applying a three-dimensional electric field. Then, the positional relationship displayed by the three-dimensional electric field is corrected using the absolute position of the head end electrode 12 and the proximal end electrode 13 (calculated using the absolute positional relationship with the magnetic sensor), and then the accurate ring electrode 3 component morphology is displayed.

[0051] Please refer to Figure 5 In this embodiment, there are two upper arms 4 and two lower arms 5. The two upper arms 4, four support arms 7 and two lower arms 5 are all arranged around the traction member 6. The main support of the two upper arms 4 is arranged around the axis 8 of the head end 1, and the main support of the two lower arms 5 is arranged around the axis 8 of the proximal tube 2. The two upper arms 4 and the two lower arms 5 form a symmetrical structure about the traction member 6, so that when the upper arms 4, support arms 7 and lower arms 5 are extended, they can spread out in all directions to form a balanced and stable support within the cavity tissue. The upper arm 4 and lower arm 5 are Y-shaped structures, each consisting of a main branch and two sub-branches. The head end 1 connects to the main branches of the two upper arms 4, and the proximal tube body 2 connects to the main branches of the two lower arms 5. The two ends of the four support arms 7 are connected to branches of the upper arm 4 and branches of the lower arm 5, respectively. Adjacent branches of the two lower arms 5 are connected to the two branches of the same upper arm 4 via support arms 7, and adjacent branches of the two upper arms 4 are connected to the two branches of the same lower arm 5 via support arms 7. This allows the branches of the upper arm 4 and the branches of the lower arm 5 to be connected in a staggered manner via support arms 7. The branches of the upper arm 4, support arms 7, and branches of the lower arm 5 are all coaxially arranged, meaning that the branches of the upper arm 4, support arms 7, and branches of the lower arm 5 are located on the same axis, resulting in a smooth connection between the upper arm 4, support arms 7, and lower arm 5. The four Y-shaped structures and support arms 7 of the catheter form a grid-like three-dimensional sphere. This structure has excellent support, allowing the catheter to fit well within the tissue cavity, and it can also maintain the original state of the catheter when subjected to external pressure.

[0052] The inner filling of the outer material of the upper arm 4, the branch arm 7 and the lower arm 5 is provided with an elastic material piece, a temperature sensor and an electrode lead wire, wherein the temperature sensor and the electrode lead wire are prior art, the temperature sensor is connected with the electrode lead wire, the electrode lead wire has the functions of signal acquisition, signal release, energy release and temperature detection, the temperature sensor is used for sensing the temperature near the catheter, the electrode lead wire is used for energy transmission and temperature detection of the ring electrode 3, the elastic material piece is in the form of a wire, a sheet or a tube, and is used as a framework to provide the required level of support and rigidity for the upper arm 4, the branch arm 7 and the lower arm 5, and at the same time, the elastic material piece provides certain tension, elasticity and torque, so that the upper arm 4, the branch arm 7 and the lower arm 5 have certain toughness, are easy to bend and restore deformation, and the elastic material piece is a composite material with shape memory function, including nickel-titanium alloy, nickel-titanium-palladium alloy and shape memory polymer.

[0053] The four branch arms 7 of the embodiment are respectively provided with two ring electrodes 3, the two ring electrodes 3 are arranged at intervals, and the positions of the ring electrodes 3 on different branch arms 7 are opposite, when the ring electrodes 3 are selected to discharge, at least two ring electrodes 3 are selected as the whole discharge end to stimulate or ablate, at least one ring electrode 3 is used as the positive electrode, and at least one ring electrode 3 is used as the negative electrode; after the upper arm 4 and the lower arm 5 are unfolded, the ring electrodes 3 on the four branch arms 7 are arranged on two circles, four ring electrodes 3 are located on the same circle, and the other four ring electrodes 3 are located on the other circle, the plane where the ring electrodes 3 are located is an electrode plane, the two circles are respectively located on two parallel electrode planes, which are a first electrode plane 66 and a second electrode plane 77, the included angle between the axial direction of the traction member 6 and the electrode plane where the circle is located ranges from 80° to 90°, and the embodiment is a perpendicular relationship, that is, the traction member 6 is coaxially arranged with the head end 1 and the proximal tube body 2, that is, the three are located on the same axial line 8, and the traction member 6 is perpendicular to the first electrode plane 66 and the second electrode plane 77, so that the ring electrodes 3 can be synchronously contracted or unfolded, can be well supported on the inner wall of the cavity tissue, and can ablate the tissue through the multiple ring electrodes 3; the size of the embodiment is as follows: the length of the ring electrode 3 is 0.5 mm, the outer diameter is 0.5 mm, the circle formed by the four ring electrodes 3 has a circle diameter of 3.0 mm in a natural state, the size of the ring electrode 3 can be set according to different uses, and different sizes of cavity tissues can be adapted.

[0054] When the head end 1, the upper arm 4, the branch arm 7, the lower arm 5 and the proximal tube body 2 are in the natural state, the upper arm 4, the branch arm 7 and the lower arm 5 are close to each other and are in the shape of an olive. This makes it easier for the spherical tube to enter and pass through a small cavity tissue and helps to form a pre-sticking and contact in the cavity tissue. In actual use, in some relatively narrow or difficult-to-enter cavity tissues, in order to smoothly pass through, a guide instrument such as a guide wire can be used in the hollow channel 55 of the catheter to guide the catheter to make it more easily and quickly enter the target tissue area, which is very effective. When the head end 1 and the proximal tube body 2 are close to each other by pulling the pulling member 6, the upper arm 4, the branch arm 7 and the lower arm 5 expand to form a sphere. At this time, the first electrode plane 66 and the second electrode plane 77 are always perpendicular to the axis 8, and the circumference where the ring electrodes 3 are located becomes larger. In this way, the spacing between the ring electrodes 3 on different branch arms 7 increases, which prevents the ring electrodes 3 from overlapping and avoids the wrong judgment of the lesion by the doctor, causing damage to the non-lesion tissue. Please refer to Figure 6 When the head end 1 and the proximal tube body 2 are close to each other until the upper arm 4, the branch arm 7 and the lower arm 5 expand to form a petal shape, i.e. the first electrode plane 66 and the second electrode plane 77 overlap together, during the process that the head end 1 and the proximal tube body 2 are close to each other, the catheter changes from the natural state to the fully expanded state, and then to the petal state. All the ring electrodes 3 change from being distributed along the pulling member 6 to being distributed radially along the pulling member 6, and then to being distributed on a plane. With the change of the state of the catheter, the ring electrodes 3 adjust, and through the change of the position and distribution of the ring electrodes 3, different positions of stimulation and ablation modes are provided for the cavity tissue. Through the expansion of the upper arm 4, the branch arm 7 and the lower arm 5, the catheter can complete the variable diameter of the spherical tube in a large-diameter cavity tissue, so that the catheter is suitable for different sizes of cavity tissues and forms a stable sticking to perform ablation. When ablation is performed on the cavity tissue, the shape of the catheter can be adjusted according to the diameter of the cavity. When the diameter of the cavity is small, please refer to Figure 7 , such as blood vessel tissue 14, the natural state of the catheter can be used to ablate the sticking to the cavity structure, and when the diameter of the cavity is large, please refer to Figure 8 , such as the pulmonary vein vestibule 9, the petal shape can be changed to increase the diameter of the catheter so that the ring electrodes 3 can stably stick to the tissue for ablation.

[0055] Example 2

[0056] This embodiment is substantially the same as example 1, except that the number of Y-shaped structures of the upper arm 4 and the lower arm 5 and the number of branch arms 7 are different, the grid-shaped three-dimensional spherical structure formed by the upper arm 4, the branch arm 7 and the lower arm 5 is different, and the size of the ring electrodes 3 is also different.

[0057] Please refer to Figure 9 , Figure 10 and Figure 11In the embodiment, the upper arms 4 and the lower arms 5 are each provided as four, and the Y-shaped structures are eight in total. The loop electrodes 3 on each support arm 7 are also two, and the four upper arms 4, the eight support arms 7 and the four lower arms 5 are all arranged around the traction member 6. The main branches of the four upper arms 4 are arranged around the axis 8 of the head end 1, and the main branches of the four lower arms 5 are arranged around the axis 8 of the proximal tube body 2. The four upper arms 4 and the four lower arms 5 form structures symmetrical about the traction member 6, respectively, so that when the upper arms 4, the support arms 7 and the lower arms 5 are unfolded, they can diverge to all directions to form balanced and stable support in the cavity tissue. The upper arms 4 and the lower arms 5 are each in a Y-shaped structure, which includes a main branch and two branches. The head end 1 is connected to the main branches of the four upper arms 4, and the proximal tube body 2 is connected to the main branches of the four lower arms 5. The two ends of the eight support arms 7 are connected to the branches of the upper arms 4 and the branches of the lower arms 5, respectively. The adjacent branches of the two adjacent lower arms 5 are connected to the two branches of the same upper arm 4 through the support arm 7, and the adjacent branches of the two adjacent upper arms 4 are connected to the two branches of the same lower arm 5 through the support arm 7. The branches of the upper arms 4 and the branches of the lower arms 5 are connected in a staggered manner through the support arm 7, and the branches of the upper arms 4, the support arm 7 and the branches of the lower arms 5 are coaxially arranged, i.e., the branches of the upper arms 4, the support arm 7 and the branches of the lower arms 5 are located on the same axis, so that the upper arms 4, the support arm 7 and the lower arms 5 are smoothly connected. Through the eight Y-shaped structures and the support arms 7 of the catheter, a grid-shaped three-dimensional spherical shape is formed. This structure has good supportability, so that the catheter can be well attached to the cavity tissue, and when subjected to external pressure, the catheter can also maintain the original state.

[0058] The loop electrodes 3 in the embodiment are 16 in total. Every two loop electrodes 3 are sleeved on the same support arm 7, and the eight loop electrodes 3 on different support arms 7 are located on the same circumference. There are two circumferences, and the planes where the two circumferences are located are the first electrode plane 66 and the second electrode plane 77, respectively. The length of the loop electrode 3 is 5.0 mm, and the outer diameter is 3.0 mm. The size of the electrode 3 can also be: length 30.0 mm, outer diameter 30.0 mm. The diameter of the circumference formed by the plurality of loop electrodes 3 in the fully unfolded state is 30.0 mm. The size of the loop electrode 3 can be set according to different uses to adapt to different sizes of cavity tissues.

[0059] Embodiment 3

[0060] Please refer to Figure 12 The embodiment provides a use method of the shape-variable catheter. The shape-variable catheter in Embodiment 1 or Embodiment 2 is used, and the use method comprises the following steps.

[0061] S1, the catheter in a natural state is inserted into the cavity tissue;

[0062] S2, through the traction member 6, the head end 1, the upper arm 4, the branch arm 7 and the lower arm 5 are stretched out or close, the radial dimension of the catheter is enlarged or reduced, and the circumferences of all the ring electrodes 3 and the branch arms 7 are supported on the inner wall of the cavity tissue, matching different sizes of the cavity tissue;

[0063] S3, through the ring electrodes 3, the lesion tissue position is confirmed, and the ring electrodes 3 are used for accurate stimulation to find the accurate position of the lesion tissue, and the stimulation of the ring electrodes 3 is carried out by using low-frequency energy or high-frequency energy.

[0064] The stimulation mode of the ring electrodes 3 is used to accurately position the lesion tissue position, including three kinds:

[0065] At least two ring electrodes 3 on all branch arms 7 are used as a whole discharge end for stimulation; here, at least two ring electrodes 3 on the same branch arm 7 can be selected, or at least two ring electrodes 3 on different branch arms 7 can be selected, that is, two or more ring electrodes 3 are selected as the discharge end, but the selection of all ring electrodes 3 is not included, in the embodiment, two ring electrodes 3 on the branch arm 7 are used as a whole discharge end, and the device sends a stimulation signal to the two ring electrodes 3, one of which is used as a positive electrode and the other of which is used as a negative electrode, and similarly, two ring electrodes 3 on different branch arms 7 can also be used as a discharge end, and the stimulation mode is used to roughly find the lesion tissue position and determine that the target point is closer to a certain ring electrode 3, and then the next operation is performed.

[0066] All ring electrodes 3 on all branch arms 7 are stimulated to find the target point or test the ablation effect, and the isolation operation of the cavity tissue can be performed on each ring electrode 3, and after all the ring electrodes 3 are in close contact with the cavity tissue, the lesion tissue position of the cavity tissue can be found by stimulating all the ring electrodes 3.

[0067] At least one ring electrode 3 is used to stimulate the back electrode plate; the back electrode plate is attached to the back of the patient or the outside of other tissues of the patient, and then one or more ring electrodes 3 of the catheter are selected, and the multiple ring electrodes 3 can be located on the same branch arm 7 or on different branch arms 7, and then the selected ring electrodes 3 are stimulated to find the lesion tissue position.

[0068] Embodiment 4

[0069] The embodiment provides a use method of a shape-variable catheter, and the shape-variable catheter in the above embodiment 1 or the embodiment 2 is used, and the use method comprises the following steps:

[0070] S1, the catheter in a natural state is inserted into the cavity tissue;

[0071] S2, by pulling the head end 1, the upper arm 4, the branch arm 7 and the lower arm 5 through the traction member 6, the radial dimension of the catheter is enlarged or reduced, and the circumferential support formed by all the ring electrodes 3 and the branch arms 7 matches the inner wall of the cavity tissue of different sizes;

[0072] S3, by stimulating the cavity tissue through the ring electrodes 3, the lesion tissue position is confirmed, and then the ring electrodes 3 are discharged to ablate the lesion tissue. The discharge of the ring electrodes 3 is carried out by using radio frequency energy or high voltage pulse energy.

[0073] The discharge mode of the ring electrodes 3 for ablation of the lesion tissue includes three modes:

[0074] At least two ring electrodes 3 on all branch arms 7 are used as a whole discharge end for discharge. Here, it means that at least two ring electrodes 3 on the same branch arm 7 or on different branch arms 7 are selected as the discharge end, that is, two or more ring electrodes 3 are selected as the discharge end, but the selection of all ring electrodes 3 is not included. The discharge mode is that the lesion tissue position has been roughly found out, and when it is not determined that the lesion tissue target point is closer to a certain ring electrode 3, such as the midpoint between two ring electrodes 3, the discharge of the two ring electrodes 3 is selected. In this embodiment, the two ring electrodes 3 on the branch arm 7 are used as a whole discharge end, and the ablation energy is emitted to the two ring electrodes 3 by the device, one ring electrode 3 is used as the positive electrode, and the other ring electrode 3 is used as the negative electrode. Similarly, different ring electrodes 3 on different branch arms 7 can be used as the discharge end, and the above discharge end is used for ablation to achieve the purpose of ablation with smaller damage area.

[0075] All ring electrodes 3 on all branch arms 7 are discharged. All ring electrodes 3 on all branch arms 7 are discharged to form a ring-shaped ablation isolation band, such as the isolation operation of the pulmonary vein vestibule 9. Each ring electrode 3 can be discharged to form a ring-shaped isolation. After the ring electrodes 3 are in close contact with the tissue of the pulmonary vein vestibule 9, the discharge ablation is carried out, and the energy between the ring electrodes 3 acts on the tissue to form the ablation of the tissue in the electrode area. After the above ablation operation of all ring electrodes 3 on all branch arms 7, a ring-shaped ablation isolation band is formed in the area of the pulmonary vein vestibule 9.

[0076] Among them, the discharge of at least two ring electrodes 3 and all ring electrodes 3 belongs to the inter-electrode discharge mode, which can produce the effect of shallow ablation of the lesion tissue with smaller damage area.

[0077] The back electrode plate can also be discharged by at least one ring electrode 3; one ring electrode 3 on the support arm 7 can be selected to discharge the back electrode plate, or any two or more ring electrodes 3 on any support arm 7 can be selected to discharge the back electrode plate, or all ring electrodes 3 on all support arms 7 can be selected to discharge the back electrode plate; the back electrode plate is attached to the back of the patient or other tissues on the outside of the patient, and then the selected ring electrode 3 is used to discharge the back electrode plate to achieve the purpose of deep ablation.

[0078] The use of the catheter can adjust the shape of the catheter according to the inner diameter of the cavity tissue; when the inner diameter of the cavity tissue is small, the catheter in the natural state is used to adhere to the cavity tissue; when the inner diameter of the cavity tissue is large, the diameter of the catheter is increased to make the catheter adhere to the cavity tissue; the catheter can be stably deployed, the Y-shaped structure can make the ring electrode 3 stably adhere to the tissue to perform ablation and prevent the ring electrode 3 from overlapping; through the three stimulation or discharge modes, different technical effects are achieved; through the multiple electrode stimulation modes, the lesion tissue position is accurately found; through the inter-electrode discharge mode of the multiple ring electrodes 3 and all ring electrodes 3, the lesion tissue is superficially ablated; through the discharge between the single ring electrode 3 and the back electrode plate, the multiple ring electrodes 3 and the back electrode plate, and all ring electrodes 3 and the back electrode plate, deep ablation of the lesion tissue is achieved.

[0079] The upper arm 4 and the lower arm 5 provide a Y-shaped structure, the support arm 7 is connected to the Y-shaped structure to form a staggered connection structure, adjacent branches of adjacent upper arms 4 are connected to the same lower arm 5 through the support arm 7, adjacent branches of adjacent lower arms 5 are connected to the same upper arm 4 through the support arm 7, the head end 1 and the proximal tube body 2 are pulled close to each other or naturally stretched through the traction of the traction member 6, the structure formed by the upper arm 4, the support arm 7 and the lower arm 5 is deployed or close, when deployed, a grid-shaped spherical structure is formed, which plays a supporting and restraining effect, so that the catheter can stably maintain the shape and be supported on the inner wall of the cavity tissue; the catheter can maintain stability, ensure that the ring electrode 3 is well attached to the tissue, effectively avoid the problem of electrode overlapping due to external force, ensure the smooth release of energy and safety, achieve the purpose of not damaging healthy human tissues, in addition, the catheter can be applied to cavity tissues of different diameters and shapes, and has strong applicability.

[0080] The above only describes the preferred embodiments of the present application and is not intended to limit the present application, any modification, equivalent replacement and improvement made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A morphologically variable catheter, comprising a distal end, an electrode, a proximal body, and a traction component connecting the distal end and the proximal body, characterized in that, It also includes an upper arm, a support arm, and a lower arm. The upper arm and lower arm are each Y-shaped, with each Y-shaped structure including a main branch and two branches. The head end connects to at least two main branches of the upper arm, and the proximal tube connects to at least two main branches of the lower arm. The two ends of the support arm connect to branches of the upper arm and branches of the lower arm, respectively. Adjacent branches of two adjacent lower arms are connected to two branches of the same upper arm via support arms, and adjacent branches of two adjacent upper arms are connected to two branches of the same lower arm via support arms, so that the branches of the upper arm and the branches of the lower arm are connected in a staggered manner via support arms. The electrode is sleeved on the support arm. The upper arm, support arm, and lower arm are close to each other in an olive shape, and the head end and the proximal tube are close to each other. When unfolded, the upper arm, support arm, and lower arm expand to form a spherical shape, until they expand into a petal shape. The upper arm, support arm, and lower arm are internally provided with elastic components and wires. The elastic components are either wrapped around the outside of the wires or located inside the wires. The elastic components are filamentous, sheet-like, or tubular, serving as a support skeleton. Each support arm is provided with at least one electrode. Electrodes at the same corresponding position on different support arms are arranged on the same circumference, forming at least one circumference. After the upper arm and lower arm expand, the radius of the circumference increases. The axial direction of the traction member forms an angle with the electrode plane of the circumference, the angle ranging from 80° to 90°. There are three ways to stimulate or discharge electrodes: stimulating or discharging at least two electrodes on all arms as a whole, stimulating or discharging all electrodes on all arms, and stimulating or discharging the back plate through at least one electrode.

2. The morphologically variable catheter according to claim 1, characterized in that, The electrode includes a ring electrode, a spindle-shaped electrode, a flat electrode, a rod-shaped electrode, or an irregularly shaped electrode, and the length of the electrode ranges from 0.5 mm to 30.0 mm, and the outer diameter ranges from 0.5 mm to 30.0 mm.

3. The morphologically variable catheter according to claim 1, characterized in that, All of the upper arms, outriggers, and lower arms are arranged around the traction member, with the main support of all the upper arms arranged around the axis of the head end and the main support of all the lower arms arranged around the axis of the proximal tube.

4. The morphologically variable catheter according to claim 1, characterized in that, As the head end and proximal end of the tube approach each other, the catheter changes from a natural state to a fully expanded state, and then to a petal-like state. All the electrodes change from being distributed along the direction of the traction member, to being distributed radially along the traction member, and then to being distributed on a single plane.

5. The morphologically variable catheter according to any one of claims 1-4, characterized in that, The head end is provided with a head end electrode and a first magnetic positioning sensor, and the proximal end tube is provided with a proximal end electrode and a second magnetic positioning sensor to determine the position of the catheter.

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