Ablation equipment and assembly method thereof

Abstract

The invention provides ablation equipment and an assembly method of the ablation equipment, which are used for solving the problem that in the prior art, after a focus is ablated, an ablation area formed by two adjacent groups of electrodes has an interval or is narrow. The distance C between two adjacent copper foils between two groups of electrodes is set to be larger than or equal to one third of the center distance between the two copper foils of the same group of electrodes minus the width of the copper foils and smaller than or equal to four times of the center distance between the two copper foils of the same group of electrodes. Therefore, the problem that the inner side wall part of the duodenum is not ablated due to the fact that the distance between the copper foils of the two groups of electrodes is too large can be avoided, and the problem that the space between two ablation areas is narrow can also be avoided.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and particularly relates to an ablation device and an assembly method thereof. Background Art

[0002] Type II diabetes is a complex metabolic disease, the mechanism of which causes hyperglycemia disorder through insulin resistance (body cells cannot correctly utilize the produced insulin) and insufficient insulin production to meet the body's needs, and then causes the body's autoimmune destruction of pancreatic β cells, resulting in the body's inability to produce enough insulin.

[0003] To treat type II diabetes, an ablation device can be inserted into the duodenum, and a flexible circuit board is expanded by an expansion member to make the flexible circuit board fit against the inner wall of the duodenum; then an energy delivery unit supplies energy to the flexible circuit board to ablate the diseased mucosa on the inner wall of the duodenum through the flexible circuit board. After ablation, the mucosal repair and healing reaction is triggered to reconstruct healthy mucosal tissue, so as to achieve the purpose of treating type II diabetes.

[0004] In actual use, since the duodenal lesions of diabetic patients are usually circumferentially all lesions, circumferential ablation of the duodenal mucosa is required. When ablating the mucosal layer simultaneously, due to the large ablation area, the impedance is significantly reduced, which is easily confused with the situation of short circuit, and is not conducive to safety control. Therefore, multiple groups of electrodes are arranged at intervals on the flexible circuit board, and at least one copper foil for contacting the diseased mucosa is arranged on each group of electrodes. Multiple groups of electrodes can ablate the diseased mucosa simultaneously, or ablate one by one, or only use one or more of them each time for ablation.

[0005] However, due to the multiple groups of electrodes on the flexible circuit board being arranged at intervals, if the interval distance between adjacent two groups of electrodes is too large, after ablation, there will be an interval between the ablation areas formed on the inner wall of the duodenum. The generation of the interval will cause changes in the process of cell regeneration. In addition to the fact that the same lesion cannot be completely ablated at one time, the mucosa at the interval can complete mucosal repair through cell migration, without triggering the healing reaction and without reconstructing the healthy mucosal reaction. If the interval distance between adjacent two groups of electrodes is too small, the interval area will be repeatedly ablated, resulting in overlap or adhesion between the ablation areas formed on the inner wall of the duodenum, that is, stenosis is formed. Summary of the Invention

[0006] In view of the above-mentioned disadvantages of the prior art, the purpose of the present invention is to provide an ablation device and an assembly method thereof, which are used to solve the problem that there is an interval or stenosis between the ablation areas formed by adjacent two groups of electrodes after ablating the lesion in the prior art.

[0007] To achieve the above and other related objectives, the present invention provides an ablation device, comprising: a catheter, an expansion member, a flexible circuit board, and an energy delivery mechanism; the expansion member is connected to the distal end of the catheter, the flexible circuit board is disposed on the expansion member, and can be unfolded or rolled up circumferentially along the expansion member under the action of the expansion member; the energy delivery mechanism is disposed at the proximal end of the catheter and is electrically connected to the flexible circuit board for supplying energy to the flexible circuit board; the flexible circuit board includes multiple groups of electrodes, at least two copper foils are disposed on each group of electrodes, the center distance between adjacent two copper foils is Amm, the width of the copper foil is Bmm, and the distance between adjacent two copper foils of adjacent two groups of electrodes is Cmm; wherein, 4A≧C≧1 / 3(A - B).

[0008] Optionally, the expansion member includes a first limiting portion, a second limiting portion, and an expansion member body, the first limiting portion and the second limiting portion are spaced apart on the expansion member body; one end of the flexible circuit board is connected to the expansion member body, and the flexible circuit board is located between the first limiting portion and the second limiting portion; in the unexpanded state of the expansion member, the diameters of the first limiting portion and the second limiting portion are greater than the diameter of the expansion member body.

[0009] Optionally, the width of the flexible circuit board is greater than or equal to 10mm; and / or, the diameter of the expansion member after expansion is 20 - 45mm; and / or, the value range of the center distance A between adjacent two copper foils on each group of electrodes is 0.3mm - 4mm; and / or, the relationship between the center distance A between adjacent two copper foils and the width B of the copper foil on each group of electrodes is 3 / 4A≥B≥1 / 20A; and / or, the thickness of the first limiting portion and the second limiting portion is greater than the thickness of the expansion member body; and / or, the thickness of the first limiting portion and the second limiting portion is greater than or equal to the thickness of the flexible circuit board.

[0010] Optionally, the flexible circuit board is in a spiral shape, one end of the inner layer of the flexible circuit board is connected to the expansion member, and limiting blocks are respectively disposed on the upper side and the lower side of the inner layer of the flexible circuit board.

[0011] On the other hand, the present invention also provides an assembly method of an ablation device, including assembling an ablation device as described above, comprising: an assembly step of the catheter and the expansion member: sleeving the expansion member on the catheter; an assembly step of the expansion member and the flexible circuit board: bonding one end of the flexible circuit board to the expansion member.

[0012] Optionally, the shaping process of the flexible circuit board includes the following steps: S1. Fix the bent flexible circuit board by using a shaping tool; S2. Perform high-temperature treatment on the bent flexible circuit board to obtain a shaped flexible circuit board.

[0013] First, fix the bent flexible circuit board by using a shaping tooling fixture, so that the molecular chains of the substrate in the flexible circuit board undergo directional relaxation under the constraint of the shaping tooling fixture, initially forming a bent shape. Then, perform high-temperature treatment on the bent flexible circuit board, effectively enhancing the movement ability of the polymer molecular segments. At the same time, the high-temperature treatment promotes the recrystallization of copper grains in the flexible circuit board to change the original state of the flexible circuit board and control the deformation error within ±5%, thereby ensuring the accuracy and process realization of the shaped flexible circuit board. Furthermore, after high-temperature treatment, the residue of the adhesive is effectively decomposed, the extractables are reduced, and a dense CuO / Cu2O film (thickness 50 - 100 nm) is formed on the high-temperature oxidized copper layer to inhibit the migration of copper ions, thereby improving the biological safety of the FPC. It solves the problem that the existing FPC cannot achieve three-dimensional structure shaping, and also solves the problem of biological safety existing in the existing FPC.

[0014] Optionally, the shaping process of the flexible circuit board further includes: S3. According to the process design, perform at least one S1 and S2 operation on the obtained shaped flexible circuit board. The operation is directed at the remaining unshaped part of the shaped flexible circuit board, and the three-dimensional structure shaping of the entire flexible circuit board is gradually completed through multiple segmented operations.

[0015] The inventor of this case found in actual research that for some complex three-dimensional structures, when using two or more shaping tooling fixtures to shape different parts of the flexible circuit board simultaneously, there will not only be inconvenience in operation, making the process difficult to implement, but also a large deformation error after subsequent high-temperature treatment, making it difficult to meet the accuracy requirements. After multiple experimental studies, it was found that it can be completed by using the method of step-by-step heating and shaping, that is, through at least two repeated shaping and high-temperature treatments. The first time, shape the part with less bending deformation and a flatter shape, and the second time, perform a second treatment on the local structure with larger deformation, successfully controlling the deformation error within ±5%, thereby ensuring the accuracy and process realization of the shaped flexible circuit board.

[0016] Among them, when performing S3, it is necessary to remove the obtained shaped flexible circuit board from the shaping tooling fixture and then re-fix the bent flexible circuit board by using the shaping tooling fixture. The shaping tooling fixture used for each operation is selected according to the actual situation. When the shaped parts have the same shape, the same shaping tooling fixture can be used; when the shaped parts have different shapes, different shaping tooling fixtures are used.

[0017] Optionally, the temperature of the high-temperature treatment is greater than 250 °C.

[0018] Optionally, the flexible printed circuit board includes a substrate and conductors, and the conductors are connected to the substrate through an adhesive; the number of layers of the flexible printed circuit board includes single-sided boards, double-sided boards, triple-sided boards, and quadruple-sided boards.

[0019] Optionally, the thickness of the flexible printed circuit board is less than 0.5 mm.

[0020] Optionally, the substrate of the flexible printed circuit board is made of polyimide (PI) and / or polyester (PET) film.

[0021] Optionally, when the crystallization temperature of polyimide (PI) in the flexible printed circuit board is 280 - 350 °C, the temperature of the high-temperature treatment is 250 - 410 °C (excluding 250 °C and 410 °C), that is, the temperature of the high-temperature treatment is greater than 250 °C and less than 410 °C.

[0022] By precisely controlling that the temperature of the high-temperature treatment is not higher than the glass transition temperature (Tg) of polyimide (PI) plus 60 °C, the structural damage caused by the glass transition of the polymer material is avoided.

[0023] Optionally, the adhesive is selected from adhesive films, and the temperature of the high-temperature treatment is higher than the melting point of the adhesive film.

[0024] By precisely controlling that the temperature of the high-temperature treatment is higher than the melting point of the adhesive film, the purpose is to remove the residual adhesive layer to ensure biosafety.

[0025] Optionally, the adhesive film is selected from at least one of epoxy resin adhesives, acrylic adhesives, and polyurethane adhesives.

[0026] Optionally, the conductors are selected from copper, and the surface of the copper is often immersed in gold, plated with gold, or plated with silver.

[0027] Among them, immersion gold belongs to the electroless plating (electroless) process and is divided into two steps: 1) Electroless Nickel (EN) A layer of nickel-phosphorus alloy (Ni-P, the phosphorus content is usually 5 - 10%) is deposited on the copper surface through a chemical reaction, and the thickness is generally 3 - 6 μm.

[0028] The function of the nickel layer: prevent copper from diffusing into the gold layer (to avoid affecting weldability); provide mechanical support and enhance wear resistance.

[0029] 2) Immersion Gold (IG) or Immersion Silver Immersion Gold: A very thin layer of gold (0.05 - 0.1 μm) is deposited on the surface of the nickel layer through a displacement reaction.

[0030] Function of the gold layer: Provide low contact resistance and good solderability, avoid copper contacting the tissue, inhibit copper ion migration, and ensure biosafety.

[0031] Immersion silver: Deposit a very thin silver layer (0.05 - 0.1 μm) on the surface of the nickel layer through a displacement reaction.

[0032] Function of the silver layer: Provide low contact resistance and good solderability, avoid copper contacting the tissue, inhibit copper ion migration, and ensure biosafety.

[0033] Optionally, use a sizing tooling to fix the deformation of the bent flexible circuit board to be greater than or equal to the target deformation.

[0034] By controlling the sizing tooling to fix the deformation of the bent flexible circuit board to be greater than or equal to the target deformation, the springback problem after demolding is effectively avoided.

[0035] Optionally, the time of the high-temperature treatment is 5 - 60 min (excluding 5 min and 60 min), that is, the time of the high-temperature treatment is greater than 5 min and less than 60 min.

[0036] Optionally, the time of the high-temperature treatment is 10 - 40 min.

[0037] By precisely controlling the time of the high-temperature treatment, the quality and performance of the bent flexible circuit board are ensured, and the phenomenon of damage and blackening is avoided.

[0038] Optionally, the sizing tooling is a steel pipe with a cylindrical, square, rectangular, elliptical, polygonal, conical, or special-shaped structure. Among them, the shape of the sizing tooling can be adaptively set according to the configuration of the flexible circuit board to be sized in the actual process design. The material of the sizing tooling can also be selected according to the actual situation.

[0039] Optionally, the sizing tooling is a stainless steel pipe with a cylindrical structure. The sizing tooling of the stainless steel pipe with a cylindrical structure is used to locally size the flexible circuit board into a cylindrical shape in the natural state.

[0040] Optionally, the sizing tooling is composed of two stainless steel pipes with cylindrical structures of different diameters connected together by a connector. The connection method can be welding, riveting, etc. The sizing tooling composed of two stainless steel pipes with cylindrical structures of different diameters connected together by a connector is used to size a part of the flexible circuit board into a cylindrical shape in the natural state and a part into a semi-circular shape in the natural state.

[0041] Optionally, the sizing tooling includes a lower die base and an upper die base, which are buckled together. The lower die base is provided with a groove for sizing the flexible circuit board.

[0042] When dealing with a flexible circuit board for shaping a complex three-dimensional structure, various shaping tools with different configurations can be combined and applied, that is, the operations of S1 and S2 can be repeated for shaping different parts.

[0043] As described above, the present invention provides an ablation device and an assembly method of the ablation device, which at least have the following beneficial effects: 1. By setting the distance C between two adjacent copper foils between two groups of electrodes to be greater than or equal to one-third of the center distance between two copper foils of the same group of electrodes minus the width of the copper foil, and less than or equal to four times the center distance between two copper foils of the same group of electrodes, it is possible to avoid that due to the too large distance between the copper foils of the two groups of electrodes, some positions on the inner wall of the duodenum are not ablated, and it is also possible to avoid the problem of stenosis between two ablation regions.

[0044] 2. By using a shaping tool to fix the bent flexible circuit board, the molecular chains of the substrate in the flexible circuit board undergo directional relaxation under the constraint of the shaping tool, initially forming a bent shape. Then, the bent flexible circuit board is subjected to high-temperature treatment, which effectively enhances the movement ability of the polymer molecular chain segments. At the same time, the high-temperature treatment promotes the recrystallization of copper grains in the flexible circuit board to change the original state of the flexible circuit board, and controls the deformation error within ±5%, thereby ensuring the accuracy and process realization of the shaped flexible circuit board. Moreover, after high-temperature treatment, the residue of the adhesive is effectively decomposed, the extractables are reduced, and a dense CuO / Cu2O film (with a thickness of 50 - 100 nm) is formed on the high-temperature oxidized copper layer to inhibit the migration of copper ions, thereby improving the biosecurity of the FPC. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] Figure 1 It is a schematic structural diagram of an ablation device of the present invention from an angle, at this time the expansion member is in an unexpanded state.

[0046] Figure 2 It is a schematic structural diagram of another angle of an ablation device of the present invention, at this time the expansion member is in an expanded state.

[0047] Figure 3 It is a partial structural diagram of the flexible circuit board of an ablation device of the present invention, used to show the distance between the copper foils of two adjacent groups of electrodes.

[0048] Figure 4 It is a schematic structural diagram of an ablation device of the present invention from an angle in another implementation manner, at this time the expansion member is in an unexpanded state.

[0049] Figure 5 It is a schematic structural diagram of an ablation device of the present invention from an angle in yet another implementation manner, at this time the expansion member is in an expanded state.

[0050] Figure 6 Schematic diagram of the flexible circuit board structure of another implementation of the ablation device of the present invention. At this time, the flexible circuit board is in an unfolded state.

[0051] Figure 7 The first copper foil arrangement form of multiple groups of electrodes of the flexible circuit board of an ablation device of the present invention.

[0052] Figure 8 The second copper foil arrangement form of multiple groups of electrodes of the flexible circuit board of an ablation device of the present invention.

[0053] Figure 9 The third copper foil arrangement form of multiple groups of electrodes of the flexible circuit board of an ablation device of the present invention.

[0054] Figure 10 The fourth copper foil arrangement form of multiple groups of electrodes of the flexible circuit board of an ablation device of the present invention.

[0055] Figure 11 The fifth copper foil arrangement form of multiple groups of electrodes of the flexible circuit board of an ablation device of the present invention.

[0056] Figure 12 The sixth copper foil arrangement form of multiple groups of electrodes of the flexible circuit board of an ablation device of the present invention.

[0057] Figure 13 Schematic diagram of the assembly of mold A and the bent flexible circuit board.

[0058] Figure 14 Physical diagram of the shaped flexible circuit board obtained in Example 3.

[0059] Figure 15 Physical diagram of the flexible circuit board before shaping in Example 8.

[0060] Figure 16 Schematic diagram of the assembly of mold C and the bent flexible circuit board.

[0061] Figure 17 Physical diagram of the once-shaped flexible circuit board obtained in Example 8.

[0062] Figure 18 Schematic diagram of the assembly of mold B and the bent flexible circuit board.

[0063] Figure 19 Physical diagram of the shaped flexible circuit board with a complex three-dimensional structure obtained in Example 8.

[0064] Figure 20It is a physical diagram of the shaped flexible circuit board obtained in Comparative Example 1.

[0065] Figure 21 It is a physical diagram of the shaped flexible circuit board obtained in Comparative Example 2.

[0066] Figure 22 It is a physical diagram of the shaped flexible circuit board obtained by treating at different high-temperature treatment times.

[0067] Among them, 1. catheter, 2. expansion member, 21. first limiting portion, 22. second limiting portion, 23. expansion member body, 3. flexible circuit board, 31. limiting block, 4. mold A, 5. mold B, 51. left cylindrical tube, 52. right cylindrical tube, 53. connecting member, 6. mold C, 61. lower mold base, 62. upper mold base, 63. groove, 7. bent flexible circuit board. Detailed implementation manners

[0068] The following specific embodiments illustrate the implementation manners of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification.

[0069] Please refer to all the following drawings. It should be noted that the structures, ratios, sizes, etc. shown in the drawings of this specification are only used to cooperate with the content disclosed in the specification for those skilled in the art to understand and read, and are not used to limit the limiting conditions for the implementation of the present invention. Therefore, they do not have technical essential meanings. Any modification of the structure, change of the proportional relationship or adjustment of the size, without affecting the effects that the present invention can produce and the purposes that can be achieved, should still fall within the scope covered by the technical content disclosed in the present invention. At the same time, the terms such as "upper", "lower", "left", "right", "middle" and "one" cited in this specification are only for the convenience of clear narration, and are not used to limit the scope for the implementation of the present invention. The change or adjustment of their relative relationships, without substantial change in the technical content, should also be regarded as the scope for the implementation of the present invention.

[0070] The terms "distal end", "proximal end", etc. used in the present invention are only for better understanding the solution of the present invention and cannot be construed as limitations on the present invention. Generally, during the use of the ablation device, the distal part of the ablation device will extend into the human body, while the proximal part of the ablation device will remain outside the human body so that the operator can hold the handle for operation. Therefore, the "distal end" can be understood as the part of a certain part or component of the ablation device relatively close to the inside of the human body, and the "proximal end" can be understood as the part of a certain part or component of the ablation device relatively close to the outside of the human body.

[0071] The following various embodiments are only for illustration. Combinations can be made between various embodiments, and it is not limited to the content shown in the following single embodiment.

[0072] Example 1 Please refer to Figures 1 - 5 , this embodiment provides an ablation device, including: a catheter 1, a dilation member 2, a flexible circuit board 3, and an energy delivery mechanism; the dilation member 2 is connected to the distal end of the catheter 1, the flexible circuit board 3 is disposed on the dilation member 2, and can be deployed or rolled up circumferentially along the dilation member 2 under the action of the dilation member; the energy delivery mechanism is disposed at the proximal end of the catheter 1 and is electrically connected to the flexible circuit board 3 for supplying energy to the flexible circuit board 3; the flexible circuit board 3 includes multiple groups of electrodes, each group of electrodes may respectively include a positive electrode and a negative electrode, the positive electrode and the negative electrode are respectively electrically connected to the energy delivery mechanism, during use, the energy delivery mechanism can simultaneously deliver energy to multiple groups of electrodes, or can separately or one by one deliver energy to each group of electrodes to achieve ablation of the diseased mucosa on the inner wall of the duodenum. At least two copper foils are disposed on each group of electrodes, and the two copper foils are spaced apart on the flexible circuit board 3. During use, the copper foils are in direct contact with the inner wall of the duodenum, and after being electrified, each group of electrodes forms an ablation area on the inner wall of the duodenum. The center distance between two adjacent copper foils is Amm, the width of the copper foil is Bmm, and the distance between two adjacent copper foils of adjacent two groups of electrodes is Cmm; wherein, 4A≧C≧1 / 3(A - B). By setting the distance between two adjacent copper foils between two groups of electrodes, when using the ablation device to ablate the diseased mucosa on the inner wall of the duodenum to form a complete ablation area, it is possible to avoid that due to the excessive distance between the copper foils of two groups of electrodes, some positions on the inner wall of the duodenum are not ablated, and it is also possible to avoid the problem of stenosis between two ablation areas.

[0073] The value range of the center distance A between two adjacent copper foils on each group of electrodes of the flexible circuit board is 0.3mm - 4mm, and specifically it can be 1.6mm; the relationship between the center distance A between two adjacent copper foils on each group of electrodes of the flexible circuit board and the width B of the copper foil is 3 / 4A≥B≥1 / 20A; to ensure that when each group of electrodes is in use, there will be no intervals or stenosis problems within the ablation area formed by each group of electrodes.

[0074] The copper foils of multiple groups of electrodes on the flexible circuit board 3 can be linear, for example Figure 7 its extending direction can be set to coincide with the axial direction of the dilation member 2, or can also be set perpendicular to the axial direction of the dilation member 2 as shown in Figure 8 . The copper foils within multiple groups of electrodes on the flexible circuit board 3 can also be non - linear, for example Figures 9 - 12The shape shown. However, no matter how they are arranged, the distances between the multiple copper foils within each group of electrodes always remain the same, so as to ensure that there will be no stenosis or unablated blind spots in the ablation area formed after ablation of each group of electrodes.

[0075] Please refer to Figures 1 - 2 , the expansion member 2 may include a first limiting portion 21, a second limiting portion 22 and an expansion member body 23. The first limiting portion 21 and the second limiting portion 22 are arranged at intervals on the expansion member body 23. One end of the flexible circuit board 3 is connected to the expansion member body 23, and the flexible circuit board 3 is located between the first limiting portion 21 and the second limiting portion 22. When the expansion member 2 is in the unexpanded state, the diameters of the first limiting portion 21 and the second limiting portion 22 are greater than the diameter of the expansion member body 23. The first limiting portion 21 is arranged near the distal end of the catheter 1, and the second limiting portion 22 is arranged near the proximal end of the catheter 1.

[0076] Specifically, the expansion member 2 can be a balloon. The balloon can be a compliant balloon or a non-compliant balloon. In this embodiment, the balloon is a compliant balloon. The material of the compliant balloon is soft, which can avoid scratching the inner wall mucosa of the duodenum.

[0077] The balloon includes an inner layer, an outer layer and a receiving cavity for receiving a medium between the inner layer and the outer layer. When a medium such as gas or liquid is introduced into the receiving cavity, the outer layer of the balloon can undergo elastic deformation to cause the balloon to expand. The balloon can be sleeved on the outer wall of the catheter 1, and the inner layer of the balloon and the catheter 1 can be fixed together by bonding or other means to prevent the balloon from detaching from the catheter 1 during use.

[0078] As Figures 1 - 2 shown, the first limiting portion 21 and the second limiting portion 22 are provided protruding from the expansion member body 23. The first limiting portion 21 and the second limiting portion 22 can be integrally formed with the expansion member body 23. Specifically, the first limiting portion 21 and the second limiting portion 22 are connected together by an arc transition section to form the outer layer of the balloon.

[0079] Please refer to Figure 4 , the first limiting portion 21 and the second limiting portion 22 can also be cap-shaped structures, which can be sleeved on the expansion member body at intervals by bonding or other means, so that the first limiting portion 21 and the second limiting portion 22 form a limiting structure for limiting the flexible circuit board on the expansion member body 23.

[0080] One end of the flexible circuit board 3 is connected to the expansion member body 23. Specifically, one end (fixed end) of the flexible circuit board 3 can be bonded to the expansion member body 23 by means of glue or the like, and the other end (movable end) is not connected to the expansion member body 23. When the balloon is in the unexpanded state, the flexible circuit board 3 is wound around the expansion member body 23 in a multi-layered spiral structure. When the balloon changes from the unexpanded state to the expanded state, the movable end of the flexible circuit board 3 moves circumferentially around the expansion member body 23 to adapt to the diameter change of the expansion member body 23 of the balloon.

[0081] When the balloon is in the unexpanded state, the diameters of the first limiting portion 21 and the second limiting portion 22 are larger than the diameter of the expansion member body 23. Thus, by the action of the first limiting portion 21 and the second limiting portion 22, the flexible circuit board 3 is not in contact with the inner wall of the duodenum, so as to prevent damage to the inner wall of the duodenum. In addition, the first limiting portion 21 and the second limiting portion 22 can also play a role in limiting the flexible circuit board 3 when the balloon changes from the unexpanded state to the expanded state, so as to ensure that the flexible circuit board 3 can be reset to the multi-layered spiral shape.

[0082] When the balloon is in the expanded state, the diameter of the expansion member body 23 can be greater than or equal to the diameters of the first limiting portion 21 and the second limiting portion 22, so as to ensure that the flexible circuit board 3 can be in contact with the inner wall of the duodenum.

[0083] The thickness of the expansion member body 23 is less than the thicknesses of the first limiting portion 21 and the second limiting portion 22, so as to ensure that when the expansion member body 23 is in the expanded state, its diameter can be greater than or equal to the diameters of the first limiting portion 21 and the second limiting portion 22. Further, the difference between the thicknesses of the first limiting portion 21 and the second limiting portion 22 and the thickness of the expansion member body is not less than 0.5 mm, such as 0.6 mm, 0.8 mm, 0.9 mm, 1 mm. In addition, the thicknesses of the first limiting portion and the second limiting portion are greater than or equal to the thickness of the flexible circuit board, ensuring the normal use of the expansion member.

[0084] The width of the flexible circuit board 3 is greater than or equal to 10 mm, such as 10 mm, 11 mm, 12 mm, 15 mm, etc., so as to reduce the number of ablation times.

[0085] The diameter of the expansion member 2 after expansion is 20 - 45 mm, so as to ensure that after the expansion member 2 expands, the flexible circuit board 3 can be in contact with the inner wall of the duodenum.

[0086] Please refer to Figures 5 - 6, In other implementation manners, the flexible circuit board is in a spiral structure. One end (fixed end) of the inner layer of the flexible circuit board is connected to the expansion member, and limiting blocks are respectively arranged on the upper side and the lower side of the inner layer of the flexible circuit board. The limiting blocks can be bonded to the inner layer of the flexible circuit board by means of glue or the like after the flexible circuit board is processed into a spiral structure, and are used to limit the axial offset of the movable end of the flexible circuit board on the expansion member. The limiting blocks can be made of materials such as silica gel with certain elasticity, so that when the limiting blocks are in contact with the inner wall of the duodenum, the limiting blocks will not scratch the inner wall of the duodenum.

[0087] Embodiment 2 This embodiment provides an assembly method for an ablation device, including an ablation device as described in Embodiment 1, and further including: Assembly steps of the catheter 1 and the expansion member 2: The expansion member 2 is sleeved on the catheter 1. Specifically, when the expansion member 2 is a balloon, the inner layer of the balloon and the outer side wall of the catheter 1 can be fixed on the catheter 1 by means of bonding or the like.

[0088] Assembly steps of the expansion member 2 and the flexible circuit board 3: One end of the flexible circuit board 3 is bonded to the expansion member 2. Specifically, the fixed tube of the flexible circuit board 3 and the expansion member body 23 of the expansion member 2 are fixed together by means of bonding or the like. The pasting length of the flexible circuit board 3 in the circumferential direction of the expansion member 2 is 5 - 30 mm, specifically, it can be 6 mm, 10 mm, 15 mm, 20 mm, 25 mm, to ensure the firm connection between the flexible circuit board 3 and the expansion member 2.

[0089] In addition, as an advanced electronic component, the flexible printed circuit (FPC) shows broad application prospects in many fields due to its unique flexible structure, especially in the medical device field with high requirements for lightness and bendability. The FPC can achieve the light weight and flexibility that are difficult to achieve by traditional rigid circuit boards, providing strong support for the miniaturization and portability of medical devices. For example, in products such as wearable medical devices and portable diagnostic instruments, the FPC can fit with the complex shapes of the human body or devices due to its flexible characteristics, providing stable and reliable solutions for functions such as signal transmission and power management.

[0090] However, although the FPC has many advantages in the medical device field, some of its own limitations also restrict its application in a wider range of scenarios. First of all, the FPC is in a planar design. Although its bendability is suitable for some non-contact hardware (such as the cable of an endoscope or an external monitoring device), in scenarios that require complex three-dimensional structures (such as the multi-directional electrodes of a cardiac ablation catheter or the curved surface fitting of a nerve stimulator), the planar FPC cannot take into account both the passability of the catheter 1 and the tissue fitting, especially in the scenario that requires circumferential ablation of human tissue, which limits its development in related fields.

[0091] Secondly, the biosafety issue of FPC is also one of the important factors restricting its wide application in the medical device field. When medical devices come into contact with the human body, they must strictly comply with biocompatibility standards to ensure that they do not cause irritation, allergy, or other adverse reactions to human tissues. The materials of traditional FPCs have deficiencies in biocompatibility and cannot be directly used for components in contact with the human body. This limits the application of FPCs in medical devices mainly to the hardware parts that do not directly contact the human body, such as the signal transmission lines inside the device housing, etc., and their potential advantages when directly contacting human tissues cannot be fully utilized.

[0092] The following provides a shaping process for flexible printed circuit boards to solve the problem that existing FPCs cannot achieve three-dimensional structure shaping and can also solve the biosafety problem of existing FPCs.

[0093] Example 3 A shaping process for flexible printed circuit boards, comprising the following steps: S1. In order to locally shape the flexible printed circuit board into a cylindrical shape, the flexible printed circuit board is bent into a multi-layer cylindrical shape and placed in a shaping tooling with a cylindrical tubular structure (see the mold A4 shown in Figure 13 ) to complete shape fixation; wherein, the flexible printed circuit board includes a substrate, a conductor is provided on the substrate, the conductor is connected to the substrate through an epoxy resin film, the flexible printed circuit board is a double-sided board, the number of layers is a double-layer board, the substrate is a PI material, the conductor is copper, and the copper surface has been subjected to normal immersion gold treatment; S2. Under the condition of a temperature of 300 °C, the mold A4 and the bent flexible printed circuit board 7 are subjected to high-temperature treatment for 20 min together to obtain a shaped flexible printed circuit board. As shown in Figure 14 , the shaped flexible printed circuit board is cylindrical in the natural state.

[0094] Example 4 A shaping process for flexible printed circuit boards, comprising the following steps: S1. In order to locally shape the flexible printed circuit board into a cylindrical shape, the flexible printed circuit board is bent into a multi-layer cylindrical shape and placed in a shaping tooling with a cylindrical tubular structure (see the mold A4 shown in Figure 13 ) to complete shape fixation; wherein, the flexible printed circuit board includes a substrate, a conductor is provided on the substrate, the conductor is connected to the substrate through an epoxy resin film, the flexible printed circuit board is a double-sided board, the number of layers is a double-layer board, the substrate is a PI material, the conductor is copper, and the copper surface has been subjected to normal immersion gold treatment; S2. Under the condition of a temperature of 260 °C, the mold A and the bent flexible printed circuit board are subjected to high-temperature treatment for 20 min together to obtain a shaped flexible printed circuit board, and the shaped flexible printed circuit board is cylindrical in the natural state.

[0095] Example 5 A shaping process for a flexible circuit board, comprising the following steps: S1. In order to locally shape the flexible circuit board into a cylindrical shape, the flexible circuit board is bent into a multi-layer cylindrical shape and placed in a shaping tooling with a cylindrical tubular structure (see the mold A4 shown in Figure 13 ) to complete shape fixation; wherein, the flexible circuit board includes a substrate, a conductor is provided on the substrate, the conductor is connected to the substrate through an epoxy resin film, the flexible circuit board is a double-sided board, the number of layers is a double-layer board, the substrate is made of PI material, the conductor is copper, and the surface of the copper has been subjected to normal immersion gold treatment; S2. Under the condition of a temperature of 400 °C, the mold A and the bent flexible circuit board are subjected to high-temperature treatment together for 20 min to obtain a shaped flexible circuit board, and the shaped flexible circuit board is cylindrical in the natural state.

[0096] Example 6 A shaping process for a flexible circuit board, comprising the following steps: S1. In order to locally shape the flexible circuit board into a cylindrical shape, the flexible circuit board is bent into a multi-layer cylindrical shape and placed in a shaping tooling with a cylindrical tubular structure (see the mold A4 shown in Figure 13 ) to complete shape fixation; wherein, the flexible circuit board includes a substrate, a conductor is provided on the substrate, the conductor is connected to the substrate through an epoxy resin film, the flexible circuit board is a double-sided board, the number of layers is a double-layer board, the substrate is made of PI material, the conductor is copper, and the surface of the copper has been subjected to normal immersion gold treatment; S2. Under the condition of a temperature of 300 °C, the mold A and the bent flexible circuit board are subjected to high-temperature treatment together for 10 min to obtain a shaped flexible circuit board, and the shaped flexible circuit board is cylindrical in the natural state.

[0097] Example 7 A shaping process for a flexible circuit board, comprising the following steps: S1. In order to locally shape the flexible circuit board into a cylindrical shape, the flexible circuit board is bent into a multi-layer cylindrical shape and placed in a shaping tooling with a cylindrical tubular structure (see the mold A4 shown in Figure 13 ) to complete shape fixation; wherein, the flexible circuit board includes a substrate, a conductor is provided on the substrate, the conductor is connected to the substrate through an epoxy resin film, the flexible circuit board is a double-sided board, the number of layers is a double-layer board, the substrate is made of PI material, the conductor is copper, and the surface of the copper has been subjected to normal immersion gold treatment; S2. Under the condition of a temperature of 300 °C, the mold A and the bent flexible circuit board are subjected to high-temperature treatment together for 40 min to obtain a shaped flexible circuit board, and the shaped flexible circuit board is cylindrical in the natural state.

[0098] Example 8 A shaping process for a flexible circuit board. In order to shape the flexible circuit board in sections (the left side is shaped into a cylindrical shape, the middle is shaped into a bent shape, and the right side is shaped into a semi-circular shape), the following steps are included: S1. First, shape the flexible circuit board (see Figure 15 shown) into a bent shape. Place the flexible circuit board into the groove 63 of the lower die base 61 of the shaping tooling (see the mold C6 shown in Figure 16 ), and then close the upper die base 62 to complete the fixation of the bent shape of the flexible circuit board. Among them, the mold C6 includes a lower die base 61 and an upper die base 62, which are buckled together. The lower die base 61 is provided with a groove 63 for shaping. The flexible circuit board includes a substrate, on which a conductor is provided. The conductor is connected to the substrate through an epoxy resin film. The flexible circuit board is a double-sided board with a double-layer structure. The substrate is made of PI material, and the conductor is copper, and the surface of the copper has been subjected to normal immersion gold treatment; S2. Under the condition of a temperature of 300 °C, perform high-temperature treatment on the mold C and the bent flexible circuit board together for 20 minutes to obtain a once-shaped flexible circuit board. As shown in Figure 17 , the once-shaped flexible circuit board is in a bent form in the natural state; S3. Take out the once-shaped flexible circuit board in S2 from the mold C6, and then bend the right side of the once-shaped flexible circuit board and place it into the right cylindrical tube 52 of the shaping tooling (see the mold B5 shown in Figure 18 ), and then bend the left side of the once-shaped flexible circuit board into a multi-layer cylindrical shape and place it into the left cylindrical tube 51 of the mold B5 to complete the shape fixation. Among them, the mold B5 includes a left cylindrical tube 51 and a right cylindrical tube 52. One end of the connecting piece 53 is welded and fixed to the left cylindrical tube 51, and the other end is welded and fixed to the right cylindrical tube 52; Under the condition of a temperature of 300 °C, perform high-temperature treatment on the mold B and the bent once-shaped flexible circuit board together for 20 minutes to obtain a shaped flexible circuit board with a complex three-dimensional structure. As shown in Figure 19 , the shaped flexible circuit board with a complex three-dimensional structure is in a cylindrical shape on one side, bent in the middle, and semi-circular on the other side in the natural state.

[0099] Example 9 A shaping process for a flexible circuit board includes the following steps: S1. In order to locally shape the flexible circuit board into a cylindrical shape, bend the flexible circuit board into a multi-layer cylindrical shape and place it into a cylindrical-shaped shaping tooling (see Figure 13The shape is fixed in the shown mold A4); wherein, the flexible circuit board includes a substrate, a conductor is provided on the substrate, the conductor is connected to the substrate through an epoxy resin film, the flexible circuit board is a double-sided board, the number of layers is a double-layer board, the substrate is made of PI material, the conductor is copper, and the copper surface has been subjected to normal immersion gold treatment; S2. Under the condition that the temperature is 300 °C, the mold A and the bent flexible circuit board are subjected to high-temperature treatment for 10 min together to obtain a shaped flexible circuit board.

[0100] Example 10 A shaping process for a flexible circuit board includes the following steps: S1. In order to locally shape the flexible circuit board into a cylindrical shape, the flexible circuit board is bent into a multi-layer cylindrical shape and placed in a shaping tooling with a cylindrical tubular structure (see the shown mold A4) to complete shape fixation; wherein, the flexible circuit board includes a substrate, a conductor is provided on the substrate, the conductor is connected to the substrate through an epoxy resin film, the flexible circuit board is a double-sided board, the number of layers is a double-layer board, the substrate is made of PI material, the conductor is copper, and the copper surface has been subjected to normal immersion gold treatment; Figure 13 The shape is fixed in the shown mold A4); wherein, the flexible circuit board includes a substrate, a conductor is provided on the substrate, the conductor is connected to the substrate through an epoxy resin film, the flexible circuit board is a double-sided board, the number of layers is a double-layer board, the substrate is made of PI material, the conductor is copper, and the copper surface has been subjected to normal immersion gold treatment; S2. Under the condition that the temperature is 300 °C, the mold A and the bent flexible circuit board are subjected to high-temperature treatment for 30 min together to obtain a shaped flexible circuit board.

[0101] Control Example 1 An ordinary shaping process for a flexible circuit board includes the following steps: S1. In order to locally shape the flexible circuit board into a cylindrical shape, the flexible circuit board is bent into a multi-layer cylindrical shape and placed in a shaping tooling with a cylindrical tubular structure (see the shown mold A4) to complete shape fixation; wherein, the flexible circuit board includes a substrate, a conductor is provided on the substrate, the conductor is connected to the substrate through an epoxy resin film, the flexible circuit board is a double-sided board, the number of layers is a double-layer board, the substrate is made of PI material, the conductor is copper, and the copper surface has been subjected to normal immersion gold treatment; Figure 13 The shape is fixed in the shown mold A4); wherein, the flexible circuit board includes a substrate, a conductor is provided on the substrate, the conductor is connected to the substrate through an epoxy resin film, the flexible circuit board is a double-sided board, the number of layers is a double-layer board, the substrate is made of PI material, the conductor is copper, and the copper surface has been subjected to normal immersion gold treatment; S2. Under the conditions that the temperatures are 250 °C, 200 °C, and 150 °C respectively, the mold A and the bent flexible circuit board are subjected to high-temperature treatment for 20 min together to obtain a shaped flexible circuit board. The physical diagram of the shaped flexible circuit board is as shown in Figure 20 shown, Figure 20 in which, from left to right, the high-temperature treatment temperatures correspond to 250 °C, 200 °C, and 150 °C in sequence.

[0102] Control Example 2 An ordinary shaping process for a flexible circuit board includes the following steps: S1. In order to locally shape the flexible circuit board into a cylindrical shape, the flexible circuit board is bent into a multi-layer cylindrical shape and placed in a shaping tooling with a cylindrical tubular structure (see Figure 13The shape is fixed in the shown mold A4); wherein, the flexible circuit board includes a substrate, a conductor is provided on the substrate, the conductor is connected to the substrate through an epoxy resin film, the flexible circuit board is a double-sided board, the number of layers is a double-layer board, the substrate is a PI material, the conductor is copper, and the copper surface has been subjected to normal immersion gold treatment; S2. Under the condition that the temperature is 410 °C, the mold A and the bent flexible circuit board are subjected to high-temperature treatment together for 20 min to obtain a shaped flexible circuit board. The physical diagram of the shaped flexible circuit board is as Figure 21 shown.

[0103] Control Example 3 A general shaping process for a flexible circuit board includes the following steps: S1. In order to locally shape the flexible circuit board into a cylindrical shape, the flexible circuit board is bent into a multi-layer cylindrical shape and placed in a shaping tooling with a cylindrical tubular structure (see the mold A4 shown in Figure 13 ); the shape is fixed therein; wherein, the flexible circuit board includes a substrate, a conductor is provided on the substrate, the conductor is connected to the substrate through an epoxy resin film, the flexible circuit board is a double-sided board, the number of layers is a double-layer board, the substrate is a PI material, the conductor is copper, and the copper surface has been subjected to normal immersion gold treatment; S2. Under the condition that the temperature is 300 °C, the mold A and the bent flexible circuit board are subjected to high-temperature treatment together for 5 min to obtain a shaped flexible circuit board.

[0104] Control Example 4 A general shaping process for a flexible circuit board includes the following steps: S1. In order to locally shape the flexible circuit board into a cylindrical shape, the flexible circuit board is bent into a multi-layer cylindrical shape and placed in a shaping tooling with a cylindrical tubular structure (see the mold A4 shown in Figure 13 ); the shape is fixed therein; wherein, the flexible circuit board includes a substrate, a conductor is provided on the substrate, the conductor is connected to the substrate through an epoxy resin film, the flexible circuit board is a double-sided board, the number of layers is a double-layer board, the substrate is a PI material, the conductor is copper, and the copper surface has been subjected to normal immersion gold treatment; S2. Under the condition that the temperature is 300 °C, the mold A and the bent flexible circuit board are subjected to high-temperature treatment together for 60 min to obtain a shaped flexible circuit board.

[0105] Detection and analysis 1) Physical diagram comparison The physical diagram of the shaped flexible circuit board prepared by Example 1 is as Figure 14 shown. The physical diagram of the shaped flexible circuit board prepared by Control Example 1 is as Figure 20 shown. The physical diagram of the shaped flexible circuit board prepared by Control Example 2 is as Figure 21 shown.

[0106] From Figure 14 、 Figure 20 and Figure 21 Through comparative analysis, it can be seen that the flexible circuit board has a good shaping effect after being shaped at the ideal temperature (300°C), without rebound. When the temperature is lower than 300°C, obvious rebound will occur, resulting in poor shaping effect. When the temperature is higher than 410°C, the flexible circuit board will show obvious damage and blackening. This proves that precise control of the high-temperature treatment temperature is one of the key conditions to ensure the shaping and quality of the flexible circuit board.

[0107] The physical pictures of the shaped flexible circuit boards prepared in Example 9 and Example 10, and the shaped flexible circuit board prepared in Comparative Example 3 are as Figure 22 shown.

[0108] Figure 22 From left to right in [Figure] are the shaped flexible circuit boards prepared in Comparative Example 3, Example 9, Example 10, and Comparative Example 4. Through Figure 22 comparative analysis, it can be seen that when the high-temperature treatment time is less than 5 minutes, serious rebound occurs in the obtained shaped flexible circuit board. When the high-temperature treatment time is 10 minutes and 30 minutes, the obtained shaped flexible circuit board not only maintains good shaping but also does not show blackening or damage. This proves that precise control of the high-temperature treatment time is one of the key conditions to ensure the shaping and quality of the flexible circuit board.

[0109] 2) Biocompatibility test The shaped flexible circuit boards prepared in Examples 3 to 5, Examples 9 and 10, the shaped flexible circuit boards prepared in Comparative Examples 1 to 4, and the flexible circuit board before bending in Example 3 were respectively subjected to biocompatibility tests. The calculation of the biocompatible surface area was carried out according to the standard of GB / T 16886.12-2017. Since the thickness of the flexible FPC is less than 0.5 mm, according to the standard, the extraction ratio is 6 cm 2 / L, and 3 identical samples were selected for each extraction to meet the requirements of the surface area. The extraction method and the selection of the extraction solution were tested according to GB / T 16886.5-2017. The samples were extracted with a serum-containing culture medium at 37°C for 24 hours, and the cytotoxicity of the parts was evaluated by observing the cell morphology and survival rate. The safety standard refers to GB / T 16886.5-2017, and the safety standard is that the cell survival rate is not less than 70%. The test results are shown in Table 1.

[0110] Table 1 shows the survival rate test results under the condition of 100% extraction concentration Temperature / °C Time / min Survival rate (%) Flexible circuit board before bending in Example 3 \ Untreated 1 Control Example 1 150 20 1 200 20 1 250 20 45 Example 3 300 20 81 Example 4 260 20 50 Example 5 400 20 1 Example 6 300 10 70 Example 7 300 40 82 Flexible circuit board with one - time shaping in Example 9 300 20 78 Flexible circuit board with complex three - dimensional structure shaping in Example 9 300 20 80 Control Example 2 410 20 1 Example 9 300 10 71 Example 10 300 20 78 Control Example 3 300 5 1 Control Example 4 300 60 38 Table 2 shows the results of the survival rate test under the condition of 75% extraction concentration. Temperature / °C Time / min Survival rate (%) Flexible circuit board before bending in Example 1 \ Untreated 1 Control Example 1 150 20 1 200 20 1 250 20 54 Example 3 300 20 87 Example 4 260 20 58 Example 5 400 20 1 Example 6 300 10 80 Example 7 300 40 85 Flexible circuit board with one - time shaping in Example 9 300 20 82 Flexible circuit board with complex three - dimensional structure shaping in Example 9 300 20 83 Control Example 2 410 20 1 Example 9 300 10 85 Example 10 300 20 83 Control Example 3 300 5 1 Control Example 4 300 60 46 Table 3 shows the results of the survival rate test under the condition of 50% extraction concentration. Temperature / °C Time / min Survival rate (%) Flexible circuit board before bending in Example 3 \ Untreated 30 Control Example 1 150 20 31 200 20 32 250 20 64 Example 3 300 20 95 Example 4 260 20 67 Example 5 400 20 3 Example 6 300 10 88 Example 7 300 40 96 Flexible circuit board with one - time shaping in Example 9 300 20 90 Flexible circuit board with complex three - dimensional structure shaping in Example 9 300 20 93 Control Example 2 410 20 3 Example 9 300 10 91 Example 10 300 20 95 Control Example 3 300 5 30 Control Example 4 300 60 60 Table 4 shows the results of the survival rate test under the condition of 25% extraction concentration. Temperature / °C Time / min Survival rate (%) Flexible circuit board before bending in Example 3 \ Untreated 61 Control Example 1 150 20 62 200 20 61 250 20 80 Example 3 300 20 99 Example 4 260 20 85 Example 5 400 20 5 Example 6 300 10 95 Example 7 300 40 99 Flexible circuit board with one - time shaping in Example 9 300 20 97 Flexible circuit board with complex three - dimensional structure shaping in Example 9 300 20 98 Control Example 2 410 20 5 Example 9 300 10 98 Example 10 300 20 99 Control Example 3 300 5 61 Control Example 4 300 60 70 In Table 1, the 100% extraction concentration refers to the liquid obtained by soaking the medical device material in accordance with the standard ratio (6 cm 2 / mL) under specific conditions (temperature, time). The 100% extraction concentration means directly using this extraction solution for testing without any dilution, in order to reflect the biocompatibility risk of the material under the most stringent conditions. The 75% extraction concentration in Table 2 refers to the solution obtained by diluting the 100% extraction solution with physiological saline at a volume ratio of 1:3. The 50% extraction concentration in Table 3 refers to the solution obtained by diluting the 100% extraction solution with an equal volume of physiological saline (1:1 dilution). The 25% extraction concentration in Table 4 refers to the solution obtained by diluting the 100% extraction solution with physiological saline at a volume ratio of 3:1.

[0111] It can be analyzed from Tables 1 to 4 that the cell survival rates of the formed flexible circuit boards prepared in Examples 3 to 5, and Examples 9 and 10 under different concentration conditions after extraction are all greater than 70%, all meeting the safety regulation standards. At the same time, it also proves that both the temperature and time of the high-temperature treatment are the key factors affecting the biocompatibility of the formed flexible circuit board.

[0112] In summary, the present invention effectively overcomes various disadvantages in the prior art and has high industrial utilization value.

[0113] The above embodiments are only illustrative of the principles and effects of the present invention, and are not used to limit the present invention. Any person familiar with this technology can modify or change the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or changes completed by those with ordinary knowledge in the technical field without departing from the spirit and technical idea disclosed by the present invention should still be covered by the claims of the present invention.

Claims

1. An ablation device, characterized in that, Comprising: A catheter, a dilation member, a flexible circuit board, and an energy delivery mechanism; The dilation member is connected to the distal end of the catheter. The flexible circuit board is disposed on the dilation member and can be unfolded or rolled up circumferentially along the dilation member under the action of the dilation member. The energy delivery mechanism is disposed at the proximal end of the catheter and is electrically connected to the flexible circuit board for supplying energy to the flexible circuit board; The flexible circuit board includes multiple groups of electrodes. At least two copper foils are disposed on each group of electrodes. The center distance between two adjacent copper foils is A mm, the width of the copper foil is B mm, and the distance between two adjacent copper foils of two adjacent groups of electrodes is C mm. Wherein, 4A ≥ C ≥ 1 / 3(A - B).

2. The ablation device according to claim 1, wherein: The dilation member includes a first limiting portion, a second limiting portion, and a dilation member body. The first limiting portion and the second limiting portion are spaced apart on the dilation member body. One end of the flexible circuit board is connected to the dilation member body, and the flexible circuit board is located between the first limiting portion and the second limiting portion; When the dilation member is in an unexpanded state, the diameters of the first limiting portion and the second limiting portion are greater than the diameter of the dilation member body.

3. The ablation device according to claim 2, wherein: The width of the flexible circuit board is greater than or equal to 10 mm; And / or, the diameter of the dilation member after expansion is 20 - 45 mm; And / or, the value range of the center distance A between two adjacent copper foils on each group of electrodes is 0.3 mm - 4 mm; And / or, the relationship between the center distance A between two adjacent copper foils on each group of electrodes and the width B of the copper foil is 3 / 4A ≥ B ≥ 1 / 20A; And / or, the thicknesses of the first limiting portion and the second limiting portion are greater than the thickness of the dilation member body; And / or, the thicknesses of the first limiting portion and the second limiting portion are greater than or equal to the thickness of the flexible circuit board.

4. An ablation device according to claim 1, characterized in that: The flexible circuit board is in a spiral shape. One end of the inner layer of the flexible circuit board is connected to the dilation member, and limiting blocks are respectively disposed on the upper side and the lower side of the inner layer of the flexible circuit board.

5. An assembly method of an ablation device, characterized in that, For assembling an ablation device according to any one of claims 1 - 4, comprising: Assembly steps of the catheter and the dilation member: sleeving the dilation member on the catheter; Assembly steps of the dilation member and the flexible circuit board: bonding one end of the flexible circuit board to the dilation member.

6. The assembly method of an ablation device according to claim 5, wherein: The shaping process of the flexible circuit board includes: S1. Fixing the bent flexible circuit board by using a shaping tooling; S2. Performing high-temperature treatment on the bent flexible circuit board to obtain a shaped flexible circuit board; S3. According to the process design, performing at least one operation of S1 and S2 on the obtained shaped flexible circuit board. The operation is directed to the remaining unfixed part of the shaped flexible circuit board, and the three-dimensional structure shaping of the entire flexible circuit board is gradually completed through multiple segmented operations.

7. The assembly method of an ablation device according to claim 6, wherein: The temperature of the high-temperature treatment is greater than 250 °C; The flexible circuit board includes a substrate and a conductor, and the conductor is connected to the substrate through an adhesive; The number of layers of the flexible printed circuit board includes at least one of a single-sided board, a double-sided board, a triple-sided board, a quadruple-sided board, and the flexible part of a rigid-flex board; The base material of the flexible printed circuit board is selected from at least one of polyimide (PI) and polyester film.

8. The assembling method of an ablation device according to claim 7, wherein: When the crystallization temperature of polyimide in the flexible printed circuit board is 280 - 350 °C, the temperature of the high-temperature treatment is 250 - 410 °C; And / or, the adhesive is selected from adhesive films, and the temperature of the high-temperature treatment is higher than the melting point of the adhesive film; And / or, the conductor is selected from copper, and the surface of the copper is often immersed in gold, plated with gold or silver.

9. The assembling method of an ablation device according to claim 6, characterized in that: The deformation amount of the bent flexible printed circuit board fixed by the shaping tooling is greater than or equal to the target deformation amount; And / or, the total time of the high-temperature treatment is 5 - 60 min.

10. The assembling method of an ablation device according to claim 6, characterized in that: The shaping tooling is a steel pipe with a cylindrical, square, rectangular, oval, polygonal, conical, or special-shaped structure; Or, the shaping tooling is composed of two steel pipes with cylindrical structures of different diameters connected together by a connecting piece; Or, the shaping tooling includes a lower die base and an upper die base, the lower die base and the upper die base are buckled together, and the lower die base is provided with a groove for shaping the flexible printed circuit board.

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