A method for preparing an ablation device and a compatibilizer

Abstract

The embodiments of this specification disclose a method for preparing an ablation device and a compatibilizer, wherein the ablation device includes a catheter and a balloon, the catheter includes a delivery section and a freezing section, and the balloon includes an inner balloon and an outer balloon; the freezing section extends into the interior of the inner balloon, the outer balloon includes a multilayer material, and an electrode is arranged on the outer surface of the outer balloon; the multilayer material includes at least a hydrophilic layer arranged on the inner side of the outer balloon and an elastic layer arranged on the outer side of the outer balloon, and a compatibilizer is included between the hydrophilic layer and the elastic layer.

Description

Technical Field

[0001] This specification relates to the field of medical devices, and in particular to a method for preparing an ablation device and a compatibilizer. Background Art

[0002] Atrial fibrillation (AF) is one of the most common cardiac arrhythmias in clinical practice. The resulting stroke and other thromboembolic events are the leading causes of death and disability. In recent years, non-drug treatments for AF have become a research hotspot both domestically and internationally.

[0003] Clinical studies have demonstrated that electrical isolation of the pulmonary veins using ablation techniques can effectively prevent recurrence of atrial fibrillation. Currently, several ablation methods for the pulmonary veins are available, including cryoablation, pulsed electric field ablation, and radiofrequency ablation. Each of these methods has its advantages, but also its own drawbacks. Therefore, there is a desire to develop an ablation device to address the shortcomings of existing technologies. Summary of the Invention

[0004] An embodiment of the present specification provides an ablation device, comprising a catheter and a balloon, wherein the catheter comprises a delivery section and a freezing section, and the balloon comprises an inner balloon and an outer balloon; wherein the freezing section extends into the interior of the inner balloon, the outer balloon comprises a multilayer material, and an electrode is provided on the outer surface of the outer balloon; the multilayer material comprises at least a hydrophilic layer provided on the inner side of the outer balloon and an elastic layer provided on the outer side of the outer balloon, and a compatibilizer is provided between the hydrophilic layer and the elastic layer.

[0005] In some embodiments, the molecular structure of the hydrophilic layer material includes a first segment; the molecular structure of the elastic layer material includes a second segment; and the molecular structure of the compatibilizer material includes at least the first segment and the second segment.

[0006] In some embodiments, the molecular structure of the compatibilizer includes an ABAB repeating structure, wherein A is the second segment and B is the first segment.

[0007] In some embodiments, the ABAB repeating structure is arranged in a zigzag shape, wherein A and B as end groups are located on both sides of the central axis of the zigzag shape.

[0008] In some embodiments, the first segment comprises a polyurethane segment and the second segment comprises a polystyrene segment.

[0009] In some embodiments, the multi-layer material is obtained by co-extrusion using an extrusion device.

[0010] In some embodiments, the multilayer material is conductive, and an insulating layer is provided on the outer surface of the outer balloon where the electrodes are not printed.

[0011] The embodiments of this specification also provide a method for preparing a compatibilizer, which includes: preparing a first material with a preset molecular weight; performing end-capping treatment on the first material to obtain a second material; mixing a first auxiliary material into the second material to obtain a first mixed material; mixing a second auxiliary material into the first mixed material to obtain a second mixed material; and performing a polymerization reaction on the second mixed material to obtain a compatibilizer.

[0012] In some embodiments, the preset molecular weight is 1000-5000, the first material includes polyurethane, and the mass fraction of isocyanate in the first material is 5%-10%.

[0013] In some embodiments, the preparation of the first material with a preset molecular weight includes: taking polyester polyol or polyether polyol, adding diisocyanate at a first temperature, and heating to a second temperature within a preset time, and reacting to obtain the first material.

[0014] In some embodiments, the end-capping treatment of the first material to obtain the second material comprises: adding an end-capping agent having an olefinic unsaturated bond to the first material and stirring the reaction for 15 to 30 minutes, wherein the end-capping agent comprises allyl polyether alcohol.

[0015] In some embodiments, the first auxiliary material includes styrene, and mixing the first auxiliary material into the second material to obtain the first mixed material includes: adding styrene monomer to the second material, stirring and dissolving, and obtaining a uniformly mixed first mixed material.

[0016] In some embodiments, the second auxiliary material includes azobisisobutyronitrile, and the step of uniformly mixing the second auxiliary material into the first mixed material to obtain the second mixed material comprises: adding azobisisobutyronitrile to the first mixed material and stirring and dissolving for 30 minutes to 40 minutes.

[0017] In some embodiments, the polymerizing the second mixture to obtain the compatibilizer includes: controlling the temperature at 75° C. to 80° C. and the rotation speed at 150 rpm to 300 rpm under nitrogen protection, and polymerizing the second mixture for 4 to 5 hours.

[0018] The embodiments of this specification also provide a method for preparing a compatibilizer, which includes: preparing a first prepolymer having a hydroxyl group at the end, the molecular structure of the first prepolymer including a second segment; adding diisocyanate to the first prepolymer, and reacting to obtain a compatibilizer, wherein the molecular structure of the compatibilizer includes a first segment and a second segment.

[0019] In some embodiments, the molecular structure of the compatibilizer includes an ABAB repeating structure, wherein A is the second segment, B is the first segment, and the ABAB repeating structure is arranged in a zigzag shape, with A and B as end groups located on both sides of the central axis of the zigzag shape.

[0020] In some embodiments, the preparation of a first prepolymer having a hydroxyl end group, wherein the molecular structure of the first prepolymer includes a second chain segment, comprises: dissolving styrene in a solvent and adding 1% to 5% by weight of 2,2′-azobisisobutyric acid bis(2-hydroxyethyl) ester; and carrying out a polymerization reaction in a constant temperature water bath under nitrogen protection for 0.5-2 hours to obtain the first prepolymer; wherein the molecular structure of the first prepolymer includes a HO-A-OH structure, and the second chain segment includes a polystyrene chain segment.

[0021] In some embodiments, the adding of diisocyanate to the first prepolymer to react to obtain the compatibilizer includes: controlling the temperature of the first prepolymer to a first temperature and adding the diisocyanate; and raising the temperature to a second temperature within a preset time to react to obtain the compatibilizer.

[0022] In some embodiments, the step of adding diisocyanate to the first prepolymer to react to obtain the compatibilizer further includes: drying the first prepolymer before adding the diisocyanate.

[0023] In some embodiments, the step of adding diisocyanate to the first prepolymer to react to obtain a compatibilizer further includes: performing a degassing operation on the compatibilizer. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The embodiments of this specification will be further described in the form of exemplary embodiments, which will be described in detail with reference to the accompanying drawings. These embodiments are not restrictive, and in these embodiments, the same numbers represent the same structures, wherein:

[0025] Figure 1 It is a schematic diagram of the structure of the ablation device provided in some embodiments of this specification.

[0026] Figure 2 It is a schematic diagram of the balloon structure of the ablation device provided in some embodiments of this specification.

[0027] Figure 3 This is a schematic diagram of the electrode structure of the ablation device provided in some embodiments of this specification.

[0028] Figure 4 This is a schematic diagram of the electrode arrangement of the ablation device provided in some embodiments of this specification.

[0029] Figure 5It is a schematic diagram of the structure of the multilayer material in the balloon structure provided in some embodiments of this specification.

[0030] Figure 6 It is a schematic diagram of the structure of the multilayer material in the balloon structure provided in other embodiments of this specification.

[0031] Figure 7 It is a schematic flow chart of the preparation method of the compatibilizer provided in some embodiments of this specification.

[0032] Figure 8 It is a schematic flow chart of the preparation method of the compatibilizer provided in other embodiments of this specification. DETAILED DESCRIPTION

[0033] In order to more clearly illustrate the technical solutions of the embodiments of this specification, the following is a brief introduction to the drawings required for the description of the embodiments. Obviously, the drawings described below are only some examples or embodiments of this specification. For ordinary technicians in this field, this specification can also be applied to other similar scenarios based on these drawings without paying any creative work. It should be understood that these exemplary embodiments are provided only to enable technicians in the relevant fields to better understand and implement this specification, and do not limit the scope of this specification in any way. Unless it is obvious from the language environment or otherwise explained, the same reference numerals in the figures represent the same structure or operation.

[0034] As used in this specification and claims, unless the context clearly indicates otherwise, the terms "a," "an," "an," and / or "the" are not intended to refer to the singular and may include the plural. Generally speaking, the terms "comprises" and "include" only indicate the inclusion of the steps and elements specifically identified, and these steps and elements do not constitute an exclusive list; the method or apparatus may also include additional steps or elements. The term "one embodiment" means "at least one embodiment"; the term "another embodiment" means "at least one additional embodiment."

[0035] In the description of this specification, it should be understood that the terms "distal end", "proximal end", "inside", "outside", "far away", "close", "one end", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings. They are only for the convenience of describing this specification and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, they should not be understood as limitations on this specification.

[0036] In this specification, unless otherwise specified or limited, terms such as "mounted," "connected," "connect," and "fixed" should be interpreted broadly. For example, "connected" can refer to a fixed connection, a removable connection, or integration; it can refer to a direct connection or an indirect connection through an intermediate medium; it can refer to internal communication between two components or an interaction between the two components. Unless otherwise specified, persons of ordinary skill in the art will understand the specific meanings of these terms in this specification based on the specific circumstances.

[0037] Clinical studies have demonstrated that electrical isolation of the pulmonary veins using ablation techniques can effectively prevent recurrence of atrial fibrillation. Currently, several ablation methods for the pulmonary veins include cryoablation, pulsed electric field ablation, and radiofrequency ablation. Each of these methods has its advantages, but also its own drawbacks. Therefore, the embodiments of this specification provide an ablation device that combines cryoablation with pulsed electric field ablation and incorporates corresponding improvements to address the shortcomings of existing technologies.

[0038] The following is a detailed description of the ablation device provided in the embodiments of this specification in conjunction with the accompanying drawings. It should be noted that the following embodiments are only used to explain this application and do not constitute a limitation of this application.

[0039] Figure 1 It is a schematic diagram of the structure of the ablation device provided in some embodiments of this specification.

[0040] Reference Figure 1 In some embodiments, the ablation device 100 may include a catheter 110, a balloon 120, and a handle 130, wherein one end of the handle 130 is connected to one end of the catheter 110, and the balloon 120 is disposed at the end of the catheter 110 away from the handle 130. In some embodiments, the balloon 120 can be used to abut against ablation target tissues such as the pulmonary veins to perform an ablation procedure on the ablation target tissues. In some embodiments, an operator (e.g., a doctor) can operate or control the ablation device 100 through the handle 130. For example, in some embodiments, the handle 130 may include an adjustment button 140 for controlling the bending of the catheter 110. By using the adjustment button 140, the direction of the catheter 110 can be adjusted so that the balloon 120 can better abut against the ablation target tissue.

[0041] Figure 2 It is a schematic diagram of the balloon structure of the ablation device provided in some embodiments of this specification.

[0042] Reference Figure 1 and Figure 2In some embodiments, the catheter 110 may include a delivery section 111 and a freezing section 112, and the balloon 120 may include an outer balloon 121 and an inner balloon 122. The outer balloon 121 is sheathed outside the inner balloon 122, and the outer balloon 121 and the inner balloon 122 can expand or contract synchronously. The delivery section 111 and the freezing section 112 may include a metal tube 1121 for delivering refrigerant, and the portion of the metal tube 1121 located in the freezing section 112 extends into the interior of the inner balloon 122. Figure 2 In some embodiments, the end of the metal tube 1121 extending into the interior of the inner balloon 122 may include a spiral structure 1122 with an air outlet (not shown). Refrigerant transported through the metal tube 1121 can be sprayed onto the inner wall of the inner balloon 122 through the air outlet provided on the spiral structure 1122. During the spraying process, the refrigerant transforms from liquid to gas, evaporating and absorbing heat, thereby rapidly lowering the temperature of the balloon 120. At this point, the low temperature is transmitted to the adjacent human tissue through the balloon 120, causing the diseased tissue cells to freeze and inactivate, blocking the conduction of abnormal electrical potentials, and thus achieving cryoablation.

[0043] In some embodiments, the refrigerant may include nitrous oxide. In some embodiments, in order to better transfer the cooling effect of the refrigerant from the inner balloon 122 to the outer balloon 121, a vacuum can be used to extract the gas between the inner balloon 122 and the outer balloon 121, so that the inner balloon 122 and the outer balloon 121 are in close contact. It should be noted that in some embodiments, by configuring the balloon 120 as a double-layer balloon structure, the strength and sealing of the balloon 120 can be better ensured, thereby preventing refrigerant leakage from the balloon 120 from causing damage to the patient.

[0044] In some embodiments, in order to combine cryoablation with pulse ablation technology, it is necessary to provide an electrode on the outer surface of the balloon 120. In some embodiments, in order to meet the working requirements of cryoablation and the requirements of the electrode for the flexibility of the balloon 120, the material of the balloon 120 can be improved accordingly. For example, the outer balloon 121 can be configured to include multiple layers of material to ensure its flexibility. In some embodiments, the electrode can be a flexible electrode. In some embodiments, the electrode includes a conductive material, and exemplary conductive materials include carbon nanotubes, graphene, composite materials, polymer materials, nanomaterials, nanowires, etc. In some embodiments, to ensure the conductivity of the electrode, its resistance should be less than 3Ω.

[0045] More details about the multilayer material and electrodes can be found elsewhere in this specification (for example, more details about the electrodes can be found in Figure 3 、 Figure 4For more details on multilayer materials, please refer to Figure 5 Part and related discussions), which will not be described in detail here.

[0046] It should be noted that the main mechanisms of action of cryoablation technology include physical killing and inactivation of target tissues by freezing, immediate tissue damage through freezing and thawing; freezing-induced microvascular constriction and thrombosis leading to progressive microcirculatory failure and blood stasis; freeze-thaw-induced tumor cell rupture and induction of specific and nonspecific anti-tumor immune responses. After frozen tumor cells undergo necrosis, specific tumor antigens are produced, which can be recognized by the body's antigen-presenting cells, stimulating the body to produce specific immune antibodies. Through antigen-antibody binding, specific immune killing of tumor cells is initiated, which can eliminate residual tumor cells. Cryoballoons have been on the market for about ten years, and the adverse reactions they produce and the operation methods to address them are relatively mature. However, their selectivity for cells / tissues is relatively poor, and they cannot effectively protect key structures around target cells / tissues.

[0047] Pulse ablation involves applying high-voltage electrical pulses to the phospholipid bilayer of the cell membrane over a short period of time. This creates an unstable transmembrane potential, leading to irreversible permeable damage to the cell membrane and the creation of nanoscale pores. This leads to changes in cell membrane permeability, disrupting intracellular homeostasis, and ultimately causing apoptosis. By "killing" the vestibuloatrial muscle of the pulmonary veins through pulsed electric field ablation, the potential within the pulmonary veins is prevented from being transmitted, ultimately eliminating atrial fibrillation. Cryoablation can partially address the current limitation of cryoablation, which is prone to freezing damage to non-target cells / tissues. However, due to the structure and size of the electrodes themselves, reversal within the pulmonary veins can be difficult. Even if they are removed from the pulmonary veins, reversal within the left atrium and reinsertion into the pulmonary veins can be challenging, making this approach relatively unfeasible.

[0048] In some embodiments of the present specification, by combining pulse ablation technology with cryoablation technology, the selectivity for cells / tissues can be improved to a certain extent, thereby better protecting the critical structures surrounding the target cells / tissues. At the same time, by disposing the electrodes on the outer surface of balloon 120, the electrodes can be expanded or contracted along with balloon 120, thereby improving its feasibility to a certain extent. In other words, by combining pulse ablation technology with cryoablation technology, pulse ablation technology and cryoablation technology can complement each other, thereby to a certain extent alleviating the aforementioned shortcomings of cryoablation and pulse ablation technology.

[0049] Figure 3 This is a schematic diagram of the electrode structure of the ablation device provided in some embodiments of this specification.

[0050] Reference Figure 3 In some embodiments, the electrodes 1211 can be printed on the outer surface of the outer balloon 121 to achieve uniform electrode distribution and avoid the need for repeated inflation and deflation of the balloon 120, which would increase material requirements. Furthermore, by combining the electrodes 1211 with the balloon 120 through printing, the electrodes 1211 can be maintained on the outer surface of the outer balloon 121 during the inflation and deflation process, thereby improving the contact between the electrodes 1211 and the target tissue.

[0051] In some embodiments, the electrodes 1211 can be printed on the entire surface of the outer balloon 121. In some embodiments, considering that the outer surface of the outer balloon 121 is a spherical curved surface, its proximal hemisphere is usually difficult to abut the target tissue after the diameter of the outer balloon 121 reaches its maximum position. Therefore, the distal hemisphere of the outer balloon 121 is the main position for ablation of the target tissue. Based on this, in some embodiments, the electrodes 1211 can be printed only on the outer surface of the distal hemisphere of the outer balloon 121. It should be noted that in this specification, the distal hemisphere of the outer balloon 121 can refer to the 1 / 2 portion of the outer balloon 121 away from the handle 130. Similarly, the proximal hemisphere of the outer balloon 121 can refer to the 1 / 2 portion of the outer balloon 121 close to the handle 130.

[0052] Continue to refer to Figure 3 Each electrode 1211 can be connected to an energy processing unit via a separate wire 1212, allowing the energy processing unit to independently control each electrode 1211. The energy processing unit may refer to a device for generating or controlling voltage pulses. In some embodiments, the energy processing unit may include a DC voltage / signal generator and a controller for triggering voltage pulses, wherein the voltage pulses can be applied to one or more selected electrodes 1211. When the outer balloon 121 is inflated, the electrodes 1211 can be applied to the target tissue. In some embodiments, the electrodes 1211 can be energized via monopolar or bipolar energy delivery. In some embodiments, the electrodes 1211 can be used to detect physiological signals. When the balloon 120 is in contact with the target tissue, the electrodes 1211 in contact with the tissue can measure changes in cellular electrical potential. Furthermore, based on the feedback of the physiological signals detected by the electrodes 1211 and the preset coordinates of the electrodes 1211, the contact status of the electrodes 1211 can be determined, thereby achieving precise ablation and preventing the formation of bubbles and, consequently, air emboli, from the electrodes 1211 that are not fully in contact.

[0053] It should be noted that in some embodiments, the electric field strength in the corner area between the outer balloon 121 and the pulmonary vein can be reduced through the current shunt path, local or regional hot spots can be suppressed or eliminated, and local heating of the pulmonary vein tissue caused by larger current density values ​​can be avoided, thereby obtaining a safer environment and a more effective ablation effect. At the same time, the strong electric field near or inside the internal blood vessel wall can be reduced and / or eliminated, thereby reducing the possibility of blood vessel wall perforation.

[0054] In some embodiments, the outer surface of the outer balloon 121 may include a plurality of electrodes 1211, and the shapes of the electrodes 1211 include but are not limited to regular shapes such as circles, ellipses, rectangles, polygons, or other irregular shapes. In some embodiments, the plurality of electrodes 1211 may be arranged on the outer surface of the outer balloon 121 according to certain rules to facilitate coordinate positioning and printing. For example, in some embodiments, the electrodes 1211 may be arranged based on the meridians and wefts of the outer balloon 121. The meridian may refer to an arc connecting the distal endpoint and the proximal endpoint on the outer surface of the outer balloon 121, and the meridian direction may be the extension direction of the catheter 110 (refer to FIG. Figure 1 In the a direction). The latitude line may refer to a circle formed by the trajectory of a point on the spherical surface when the outer balloon 121 rotates around the extension direction of the catheter 110. The latitude line may include several circles of the same or different lengths, and any longitude lines and latitude lines are perpendicular to each other. In some embodiments, the connection line of at least two of the multiple electrodes 1211 may constitute a longitude line on the outer surface of the outer balloon 121. For example, electrode A and electrode C may constitute a longitude line, and electrode B and electrode D may constitute a longitude line. In some embodiments, the connection line of at least two of the multiple electrodes 1211 may constitute a latitude line on the outer surface of the outer balloon 121. For example, electrode A and electrode D may constitute a latitude line, and electrode B and electrode C may constitute a latitude line. In some embodiments, the multiple longitude lines and the multiple latitude lines on the outer surface of the outer balloon 121 intersect, and the electrode 1211 may be arranged at the intersection of the longitude lines and the latitude lines.

[0055] Figure 4 This is a schematic diagram of the electrode arrangement of the ablation device provided in some embodiments of this specification.

[0056] Reference Figure 4 In some embodiments, the electrodes 1211 can be positioned according to spatial locations. For example, the coordinates of any electrode 1211 can be expressed as Here, r may represent the distance between (the center point of) the electrode 1211 and the origin, which may be the center O of the outer balloon 121. π / 2-θ corresponds to the angle between the line between the electrode 1211 and the origin and the z-axis. It can represent the angle between the projection of the line between the electrode 1211 and the origin on the XOY plane and the X axis. Among them, the z axis can refer to the axial direction of the outer balloon 121, and the x axis, y axis, and z axis are perpendicular to each other. r, θ, The value range of is r∈[0,+∞),θ∈[0,π],

[0057] In some embodiments, the fit of the electrode to the pulmonary vein can be determined based on the positioning of the electrode 1211, and only the electrode 1211 that fits the pulmonary vein is used, thereby accurately achieving annular damage, reducing damage to the myocardium and blood vessels, accurately achieving annular damage, and forming isolation of the pulmonary vein potential.

[0058] In some embodiments, the diameter of electrode 1211 can be between 0.5 mm and 1.5 mm. If the diameter of electrode 1211 is too small, the distance between the two electrodes must be small enough, otherwise the damage caused to the target tissue will not be sufficient to connect them together. If the diameter of electrode 1211 is too large, the target tissue area will easily overheat and the voltage it can withstand will be greatly limited. Therefore, in some embodiments of the present disclosure, by controlling the diameter of electrode 1211 between 0.5 mm and 1.5 mm, the damage caused and the voltage it can withstand can be more appropriate. Preferably, in some embodiments, the diameter of electrode 1211 can be 1 mm.

[0059] In some embodiments, the distance between adjacent electrodes 1211 may be less than or equal to a preset distance. In some embodiments, the value of the preset distance is related to the size of the electrode 1211. For example, when the size of the electrode 1211 is 1 mm, the preset distance may be 1 to 10 mm.

[0060] In some embodiments, the flexible electrode 1211 can use a polyimide material as a substrate. The polyimide film has good flexibility and has good bonding strength with commonly used titanium or chromium. However, since the balloon is an interventional medical device, it needs to meet basic biocompatibility requirements. If metals such as titanium or chromium are used, the biocompatibility parameters will be affected. Therefore, in order to avoid using similar metals with poor biocompatibility and reduce the risks to the human body, in some embodiments, the flexible electrode 1211 can be prepared by combining metal nanoparticles with organic adhesives, and an organic solvent is used when preparing the conductive coating. At this time, how to reduce the harmfulness of organic solvents is also a matter of concern.

[0061] Specifically, due to the limited aggregation properties of metal nanoparticles, their conductivity is poor, requiring the addition of appropriate carbon materials to enhance conductivity, followed by the addition of a large amount of conductive elastomer. Furthermore, due to the reduced viscosity, the moldability of the resulting conductive layer deteriorates, resulting in a high probability of cracking and breaking.

[0062] Furthermore, the presence of the conductive layer can easily concentrate stress and / or force on the balloon 120. Repeated inflation of the balloon 120 can cause compression of the balloon 120 and potentially lead to its rupture. Current transmitted to the conductive electrode region of the balloon may also tend to accumulate along the edges of the electrodes 1211. This accumulation of current can cause the temperature at the edges of the electrodes 1211 to rise, which can also reduce the long-term elasticity of the balloon 120, making it more susceptible to brittle fracture during repeated cooling. Therefore, fundamentally changing the material of the balloon 120 is key to resolving this issue.

[0063] Based on this, it is of great significance to improve the structure of the balloon 120 to solve the unstable problems such as easy rupture and poor performance of the balloon material. Figure 5 and Figure 6 The balloon structure provided in some embodiments of this specification is described in detail.

[0064] Figure 5 It is a schematic diagram of the structure of the multilayer material in the balloon structure provided in some embodiments of this specification.

[0065] Reference Figure 5 In the embodiment of the present specification, the outer balloon 121 may include a multilayer material, including a hydrophilic layer 1213 disposed on the inner side of the outer balloon 121 and an elastic layer 1214 disposed on the outer side of the outer balloon 121. The hydrophilic layer 1213 may refer to a structural layer having a certain hydrophilic property, and the elastic layer 1214 may refer to a structural layer having a certain elastic deformation capability.

[0066] It should be noted that by providing the hydrophilic layer 1213, the outer balloon 121 can have a certain degree of hydrophilicity, thereby improving its pushing performance in the human body. However, if only hydrophilicity is considered, it may affect the adhesion of the printed electrode 1211 to the outer surface of the outer balloon 121. Therefore, in the embodiment of this specification, an elastic layer 1214 is also provided on the outside of the outer balloon 121 to improve the connection strength between the printed electrode and the outer balloon 121, and to avoid the problem of unstable coating of the electrode 1211 provided on its outer surface due to the low temperature of the cryoballoon, so that the outer balloon 121 has a multi-layer structure. In some embodiments, by configuring the outer balloon 121 to include multiple layers of material, the flexibility of the outer balloon 121 can be improved to a certain extent, thereby meeting the flexibility requirements of the electrode 1211 to the outer balloon 121.

[0067] In some embodiments, the hydrophilic layer 1213 may include a hydrophilic or hydratable matrix material, such as a hydrophilic polyurethane, a hydrophilic polyether block amide, a block copolymer with a built-in hydrophilic block, etc., wherein the block copolymer with a built-in hydrophilic block may include an ion conductor polymer, an electrical conductor polymer, a metal or nanoparticle filled polymer, etc. By mixing the hydrophilic block into the hydrophilic layer 1213, a conductive material can be incorporated. In some embodiments, the hydrophilic layer 1213 can exhibit a hydrophilicity (or water absorption rate) of 20% to 120%. In some embodiments, the elastic layer 1214 may include a thermoplastic elastomer matrix material, such as a styrene-based thermoplastic elastomer, etc. The elastic layer 1214 and the hydrophilic layer 1213 may be directly or indirectly connected.

[0068] In some embodiments, considering the risk of delamination when the elastic layer 1214 is directly connected to the hydrophilic layer 1213, and the reduced low-temperature stability, which may increase the risk of balloon rupture after freezing, in some embodiments, the multilayer material may further include a compatibilizer 1215 connecting the hydrophilic layer 1213 and the elastic layer 1214. It should be noted that, in this specification, the compatibilizer 1215 may refer to a connecting structure or substance that can improve the compatibility or adhesion between the hydrophilic layer 1213 and the elastic layer 1214. By providing the compatibilizer 1215 between the hydrophilic layer 1213 and the elastic layer 1214, a stress relief effect is generated at the interface between the two layers, thereby improving the compatibility of the multilayer material of the outer balloon 121, ensuring good uniformity between the hydrophilic layer 1213 and the elastic layer 1214, and resolving the problem of low adhesion due to the large difference in surface energy between the two layers, thereby preventing delamination between the hydrophilic layer 1213 and the elastic layer 1214. At the same time, the hydrophilic layer 1213 and the elastic layer 1214 are connected by the compatibilizer 1215, which can solve the unstable problems of the balloon material such as easy rupture and poor performance.

[0069] In some embodiments, the material molecules of the hydrophilic layer 1213 include a first chain segment, and the material molecules of the elastic layer 1214 include a second chain segment. In order to ensure that the compatibilizer 1215 has good compatibility with both the hydrophilic layer 1213 and the elastic layer 1214, the material molecules of the compatibilizer 1215 can include the aforementioned first chain segment and second chain segment at the same time.

[0070] It should be noted that the aforementioned first segment may refer to the smallest unit that can be arbitrarily oriented on the molecular chain of the material molecules of the hydrophilic layer 1213. Similarly, the second segment may refer to the smallest unit that can be arbitrarily oriented on the molecular chain of the material molecules of the elastic layer 1214.

[0071] It should also be noted that the above material molecules of the compatibilizer 1215 are merely exemplary. In some embodiments, the compatibilizer 1215 may include other components in addition to the aforementioned first segment and second segment.

[0072] In some embodiments, the molecular structure of compatibilizer 1215 may include an ABAB repeating structure, where A may represent the aforementioned second segment, and B may represent the aforementioned first segment. In some embodiments, this ABAB repeating structure allows compatibilizer 1215, when added to the mixed interface of the first segment and the second segment, to be cross-compatible with both materials, and to be connected to the two materials in both the axial and radial directions at the interface. In other words, this ABAB repeating structure allows compatibilizer 1215 to be grafted between the two materials like a three-dimensional network, thereby tightly connecting the hydrophilic layer 1213 and the elastic layer 1214. In some embodiments, the first segment may include a polyurethane segment, and the second segment may include a polystyrene segment.

[0073] Figure 6 It is a schematic diagram of the structure of the multilayer material in the balloon structure provided in other embodiments of this specification.

[0074] Reference Figure 6 In some embodiments, the aforementioned ABAB repeating structure can be arranged in a zigzag pattern, with A and B acting as end groups located on either side of the zigzag axis. Specifically, in the molecular structure of the compatibilizer 1215, the first segment B and the second segment A can be located at the peak and valley of the ABAB repeating structure, respectively. The first segment B can be connected to the hydrophilic layer 1213, and the second segment A can be connected to the elastic layer 1214.

[0075] It should be noted that through Figure 6 The structure shown can increase the connection between the hydrophilic layer 1213 and the elastic layer 1214, improve the mechanical properties of the connection, and thus strengthen the connection force between the two. Figure 6 The compatibilizer having the broken-line ABAB repeating structure can enhance the mechanical properties of the molecular chain, further improve the adhesion between the hydrophilic layer 1213 and the elastic layer 1214 , and avoid stratification between the hydrophilic layer 1213 and the elastic layer 1214 .

[0076] More details about the compatibilizer 1215 can be found elsewhere in this specification (e.g. Figure 7 and Figure 8 Part and related discussions), which will not be described in detail here.

[0077] In some embodiments, the multilayer material contained in the outer balloon 121 can be obtained by implementing a multilayer extrusion process using an extrusion device, for example, by co-extrusion. In some embodiments, the compatibilizer 1215 can be first added to the material of the hydrophilic layer 1213 or the elastic layer 1214, and then the two materials are extruded to obtain the multilayer material used to constitute the outer balloon 121. When the two materials of the hydrophilic layer 1213 and the elastic layer 1214 are compatible at the extrusion interface, other segments of the compatibilizer 1215 on the surface of the material are then combined with the other layer of material. As a result, the compatibilizer 1215 can combine the two layers of material together, and the connection interface is in a state of connection with the two materials in both the axial and radial directions, presenting a three-dimensional network connection structure, reducing the interfacial energy between the two materials, thereby making the hydrophilic layer 1213 and the elastic layer 1214 show good uniformity and resist delamination.

[0078] In some embodiments, the multilayer material contained in the outer balloon 121 may be conductive. In some embodiments, in order to improve the conductivity of the multilayer material, one or more carbonaceous materials selected from graphite and graphene carbon-based materials may be added to the mixed solution while the hydrophilic layer 1213 and the elastic layer 1214 are mixed. It should be noted that, in this specification, the multilayer material being conductive may refer to at least a portion of the region or structure in the multilayer material being conductive. For example, in some embodiments, only the portion of the multilayer material where the electrode 1211 is printed can be conductive, and the remaining portion where the electrode 1211 is not printed is sealed with an insulating material to form an insulating layer, thereby achieving accuracy in electrode positioning, so that the ablation energy is more concentrated, thereby achieving a deeper degree of damage to the target tissue.

[0079] In some embodiments, an insulating layer can be provided before or after printing electrode 1211. In some embodiments, the insulating layer can comprise a flexible polymer, such as polyimide, PTFE (Polytetrafluoroethylene, also known as Teflon), or the like. In some embodiments, the insulating layer can have a thickness of 0.01 mm to 0.03 mm. In some embodiments, the insulating layer can comprise a non-conductive polymer, such as a non-hydrophilic polyurethane, homo- and copolymeric polyurethanes, polyether block amides, nylon, polyester, or block copolymers.

[0080] In some embodiments, the conductive region or structure in the multilayer material has good adhesion to the insulating layer. For example, in some embodiments, the conductive region or structure in the multilayer material can be bonded to the insulating layer using an organic adhesive. Exemplary organic adhesives include DMF (N,N-dimethylformamide), THF (tetrahydrofuran), acetone, xylene, and the like.

[0081] The following combination Figure 7 and Figure 8 The preparation method of the compatibilizer 1215 involved in the examples of this specification is described in detail.

[0082] Figure 7 It is a schematic flow chart of the preparation method of the compatibilizer provided in some embodiments of this specification.

[0083] Reference Figure 7 In some embodiments, the method 200 for preparing the compatibilizer 1215 may include:

[0084] Step 210: Prepare a first material with a preset molecular weight.

[0085] In some embodiments, the preset molecular weight in step 210 may be 1000 to 5000. In some embodiments, the first material may include polyurethane. In other words, the first material prepared in step 210 may be polyurethane with a molecular weight of 1000 to 5000.

[0086] In some embodiments, the first material may include isocyanate groups, and the mass fraction of the isocyanate groups in the first material may be 5% to 10%. For example, in some embodiments, the mass fraction of the isocyanate groups in the first material may be 8%.

[0087] In some embodiments, the first material can be prepared by adding a certain amount of polyester polyol or polyether polyol to a diisocyanate at a first temperature, then heating the mixture to a second temperature within a predetermined time period to produce the first material. Specifically, in some embodiments, the first material can be prepared by adding a certain amount of polyester polyol or polyether polyol to a diisocyanate at 60°C, then slowly heating the mixture to 80°C over 10 to 30 minutes, and finally vacuum degassing the mixture for 30 minutes.

[0088] In some embodiments, the polyester polyol or polyether polyol may be dehydrated before the diisocyanate is added. Specifically, in some embodiments, the polyester polyol or polyether polyol may be vacuum dehydrated at 100° C. for 2 hours, cooled to 60° C., and then the diisocyanate is added.

[0089] It should be noted that the temperature, time, and other parameters involved in preparing the compatibilizer 1215 in this specification are merely illustrative. In some embodiments, these parameters can be varied within a certain range (e.g., ±10%). The same applies to the following text and will not be further elaborated in this specification.

[0090] Step 220: performing end-capping treatment on the first material to obtain a second material.

[0091] After obtaining the first material, the first material can be end-capped to produce a second material. Specifically, an end-capping agent having an olefinic unsaturated bond can be added to the first material obtained in step 210, and the mixture can be stirred and reacted for 15 to 30 minutes to produce the second material. In some embodiments, the end-capping agent includes allyl polyether alcohol.

[0092] Step 230: Mix the first auxiliary material into the second material to obtain a first mixed material.

[0093] After obtaining the second material, the first auxiliary material can be mixed into the second material to obtain a first mixed material. In some embodiments, the first auxiliary material can include styrene. Specifically, styrene monomer can be added to the second material and then dissolved by stirring to obtain a uniformly mixed first mixed material. In some embodiments, the stirring and dissolving time after adding the styrene monomer can be 15 to 30 minutes.

[0094] Step 240: mixing the second auxiliary material into the first mixed material to obtain a second mixed material.

[0095] After obtaining the first mixed material, a second auxiliary material may be added to the first mixed material to obtain a second mixed material. In some embodiments, the second auxiliary material may include azobisisobutyronitrile. Specifically, azobisisobutyronitrile may be added to the aforementioned first mixed material as an initiator, and the mixture may be stirred and dissolved for 30 to 40 minutes to obtain the second mixed material. It should be noted that the initiator can increase the rate of the polymerization reaction to a certain extent. Therefore, in some embodiments, by adding azobisisobutyronitrile as an initiator to the aforementioned first mixed material, it helps to increase the reaction rate of the subsequent polymerization reaction.

[0096] Step 250: polymerize the second mixture to obtain a compatibilizer.

[0097] After obtaining the second mixed material, the second mixed material may be polymerized to obtain the compatibilizer 1215. In some embodiments, the polymerization process of the second mixed material may include: controlling the temperature at 75° C. to 80° C. and the stirring speed of a polymerization reaction apparatus (e.g., a polymerization kettle) at 150 rpm to 300 rpm under nitrogen protection, and polymerizing the second mixed material for 4 to 5 hours to obtain the compatibilizer 1215.

[0098] In some embodiments, the compatibilizer 1215 prepared by the above process can be first added to the raw material of the hydrophilic layer 1213 (such as polyurethane) or the raw material of the elastic layer 1214 (such as styrene-based thermoplastic elastomer) during the multi-layer material extrusion process of the outer balloon 121, so that one end of the chain segment of the compatibilizer 1215 is first combined with one of the layers of material, and then, when the extrusion interface of the two materials is compatible, the other end of the compatibilizer 1215 on the surface of the material is combined with the other layer of material. In this way, the compatibilizer 1215 can combine the two layers of materials together, reduce the interfacial energy between the two materials, so that the hydrophilic layer 1213 and the elastic layer 1214 show good uniformity and resist stratification.

[0099] Figure 8 It is a schematic flow chart of the preparation method of the compatibilizer provided in other embodiments of this specification.

[0100] In other embodiments, the molecular structure of the compatibilizer 1215 includes an ABAB repeating structure, wherein A is the second segment and B is the first segment. In some embodiments, the first segment may include a polyurethane segment and the second segment may include a polystyrene segment.

[0101] Reference Figure 8 The method 300 for preparing the compatibilizer 1215 may include:

[0102] Step 310: Prepare a first prepolymer having a hydroxyl group at the end, wherein the molecular structure of the first prepolymer includes a second segment.

[0103] In some embodiments, to prepare the aforementioned compatibilizer 1215, a first prepolymer with a hydroxyl group at the end can be prepared, wherein the molecular structure of the first prepolymer includes the aforementioned second segment. Specifically, the preparation process of the first prepolymer can be referred to as follows: styrene is dissolved in a solvent (e.g., toluene), and 1% to 5% by weight of 2,2′-azobisisobutyric acid bis(2-hydroxyethyl) ester is added; then, under nitrogen protection, in a constant temperature water bath, the polymerization reaction is carried out for 0.5-2 hours to obtain the first prepolymer. The molecular structure of the first prepolymer may include a HO-A-OH structure, where A may represent the aforementioned second segment, which may include a polystyrene segment, and HO and OH may represent hydroxyl groups, that is, the end groups of the first prepolymer include hydroxyl groups.

[0104] In step 320 , diisocyanate is added to the first prepolymer to react to obtain a compatibilizer, wherein the molecular structure of the compatibilizer includes a first segment and a second segment.

[0105] After obtaining the aforementioned first prepolymer, diisocyanate may be added to the first prepolymer to react and produce the aforementioned compatibilizer 1215. Specifically, this process may include: controlling the temperature of the first prepolymer to a first temperature, adding the diisocyanate; and raising the temperature to a second temperature within a preset time, reacting to produce the compatibilizer 1215. The first temperature may be 60° C., the second temperature may be 80° C., and the preset time may be 10 to 30 minutes.

[0106] In some embodiments, before adding the diisocyanate, the first prepolymer may be purified, vacuum dried, or the like.

[0107] In some embodiments, the process of preparing the compatibilizer 1215 may further include degassing the compatibilizer 1215 .

[0108] In some embodiments, step 320 may include the following specific process: the first prepolymer may be subjected to vacuum dehydration at 100° C. for 2 hours, and after cooling to 60° C. (i.e., the first temperature), diisocyanate is added, and the temperature is slowly raised (e.g., over 10 to 30 minutes) to 80° C. (i.e., the second temperature), followed by vacuum degassing for 30 minutes, thereby preparing a compatibilizer having an ABAB repeating structure. Wherein, B may represent the first segment, which may include a polyurethane segment.

[0109] Similar to the aforementioned method 200, the compatibilizer 1215 prepared by the above-mentioned method 300 can be first added to the raw material of the hydrophilic layer 1213 (such as polyurethane) or the raw material of the elastic layer 1214 (such as styrene-based thermoplastic elastomer) in the multi-layer material extrusion process of the outer balloon 121, so that one end of the chain segment of the compatibilizer 1215 is first combined with one of the layers of material, and then, when the extrusion interface of the two materials is compatible, the other end of the compatibilizer 1215 on the material surface is combined with the other layer of material. In this way, the compatibilizer 1215 can combine the two layers of materials together, reduce the interfacial energy between the two materials, so that the hydrophilic layer 1213 and the elastic layer 1214 show good uniformity and resist stratification.

[0110] In some embodiments, testing revealed that when the mass fraction of bis(2-hydroxyethyl)-2,2'-azobisisobutyrate was 0%, 2%, 3%, 4%, and 5%, respectively, the resulting compatibilizer 1215, after being used to connect the hydrophilic layer 1213 and the elastic layer 1214, could withstand tensile strengths of 56.8 MPa, 59.9 MPa, 63.3 MPa, 67.3 MPa, and 57.4 MPa, respectively, and the corresponding elongations at break were 903%, 933%, 958%, 989%, and 900%, respectively. This indicates that when the mass fraction of bis(2-hydroxyethyl)-2,2'-azobisisobutyrate was 4%, the resulting compatibilizer 1215 exhibited relatively superior performance.

[0111] The beneficial effects that may be brought about by the ablation device provided in some embodiments of this specification include but are not limited to: (1) by combining pulse ablation technology with cryoablation technology, the pulse ablation technology and cryoablation technology can be made complementary, thereby improving the above-mentioned deficiencies of cryoablation technology and pulse ablation technology to a certain extent; (2) by setting the outer balloon to include multiple layers of material, the flexibility of the outer balloon can be improved to a certain extent, thereby meeting the flexibility requirements of the electrode on the outer balloon and improving the adhesion between the printed electrode and the outer surface of the outer balloon; (3) by setting a compatibilizer between the hydrophilic layer and the elastic layer, the outer balloon can be made more flexible. The two layers of materials are combined together, and the axial and radial directions of the connection interface are both in a state of connection with the two materials, presenting a three-dimensional network connection structure, reducing the interfacial energy between the two materials, thereby improving the connection strength between the hydrophilic layer and the elastic layer, making the hydrophilic layer and the elastic layer show good uniformity and resist delamination; (4) the hydrophilic layer and the elastic layer are connected by a compatibilizer with a broken line ABAB repeating structure, increasing the connection bond between the hydrophilic layer and the elastic layer, and improving the mechanical properties of the connection bond, thereby strengthening the connection force between the two, and further avoiding delamination between the hydrophilic layer and the elastic layer.

[0112] It should be noted that different embodiments may produce different beneficial effects. In different embodiments, the beneficial effects that may be produced may be any one or a combination of the above, or any other possible beneficial effects.

[0113] While the basic concepts have been described above, it will be apparent to those skilled in the art that the detailed disclosure is merely illustrative and does not limit this specification. Although not explicitly stated herein, various modifications, improvements, and revisions to this specification may be made by those skilled in the art. Such modifications, improvements, and revisions are suggested in this specification and remain within the spirit and scope of the exemplary embodiments of this specification.

[0114] This specification also uses specific terms to describe the embodiments of this specification. For example, "one embodiment," "an embodiment," and / or "some embodiments" refer to a feature, structure, or characteristic associated with at least one embodiment of this specification. Therefore, it should be emphasized and noted that references to "one embodiment," "an embodiment," or "an alternative embodiment" two or more times in different locations in this specification do not necessarily refer to the same embodiment. Furthermore, certain features, structures, or characteristics of one or more embodiments of this specification may be appropriately combined.

[0115] Similarly, it should be noted that, in order to simplify the presentation of this specification and thus facilitate understanding of one or more embodiments of the invention, the foregoing descriptions of the embodiments of this specification sometimes combine multiple features into a single embodiment, figure, or description thereof. However, this disclosure method does not imply that the subject matter of this specification requires more features than those recited in the claims. In fact, an embodiment may have fewer features than all of the features of a single disclosed embodiment.

[0116] In some embodiments, numbers are used to describe the quantity of components and attributes. It should be understood that such numbers used in the description of the embodiments are modified by the modifiers "about", "approximately" or "substantially" in some examples. Unless otherwise stated, "about", "approximately" or "substantially" indicate that the numbers are allowed to vary by ±20%. Accordingly, in some embodiments, the numerical parameters used in the description and claims are approximate values, which may change according to the required characteristics of individual embodiments. In some embodiments, the numerical parameters should take into account the specified significant digits and adopt the general method of retaining digits. Although the numerical domains and parameters used to confirm the breadth of their range in some embodiments of this specification are approximate values, in specific embodiments, the settings of such numerical values ​​are as accurate as possible within the feasible range.

[0117] Each patent, patent application, patent application publication, and other materials, such as articles, books, specifications, publications, and documents, cited in this specification is hereby incorporated by reference in its entirety. This includes application history documents that are inconsistent with or conflicting with the content of this specification, as well as documents that limit the broadest scope of the claims (currently or subsequently attached to this specification). It should be noted that if the descriptions, definitions, and / or terminology used in the accompanying materials are inconsistent or conflicting with the content of this specification, the descriptions, definitions, and / or terminology used in this specification will control.

[0118] Finally, it should be understood that the embodiments described in this specification are intended only to illustrate the principles of the embodiments of this specification. Other variations may also fall within the scope of this specification. Therefore, by way of example and not limitation, alternative configurations of the embodiments of this specification may be considered consistent with the teachings of this specification. Accordingly, the embodiments of this specification are not limited to the embodiments explicitly described and illustrated in this specification.

Claims

1. An ablation device, characterized in that: It comprises a catheter and a balloon, wherein the catheter comprises a delivery section and a freezing section, and the balloon comprises an inner balloon and an outer balloon; wherein, The freezing section extends into the interior of the inner balloon, the outer balloon includes a multilayer material, and a plurality of electrodes are arranged on the outer surface of the outer balloon, and the plurality of electrodes are arranged based on the warp and weft of the outer balloon; the warp refers to an arc connecting the distal end point and the proximal end point on the outer surface of the outer balloon, and the warp direction is the extension direction of the catheter; the weft refers to a circle formed by the trajectory of a point on the spherical surface when the outer balloon rotates around the extension direction of the catheter, and the weft includes a plurality of circles of the same or different lengths, and any of the warp and weft are perpendicular to each other; The multilayer material at least comprises a hydrophilic layer disposed on the inner side of the outer balloon and an elastic layer disposed on the outer side of the outer balloon, and a compatibilizer is included between the hydrophilic layer and the elastic layer; The material molecular structure of the hydrophilic layer includes a first segment; the material molecular structure of the elastic layer includes a second segment; the material molecular structure of the compatibilizer includes at least the first segment and the second segment; The molecular structure of the compatibilizer includes an ABAB repeating structure, wherein A is the second segment and B is the first segment; The ABAB repeating structure is arranged in a zigzag shape, wherein A and B as end groups are respectively located on both sides of the central axis of the zigzag shape; The first segment includes a polyurethane segment, and the second segment includes a polystyrene segment; The multi-layer material is obtained by co-extrusion through an extrusion device; The multilayer material is conductive, and an insulating layer is provided at the portion of the outer surface of the outer balloon where the electrode is not printed.

2. The ablation device according to claim 1, characterized in that: The compatibilizer is prepared by the following method: preparing a first material having a predetermined molecular weight; Performing end-capping treatment on the first material to obtain a second material; Mixing the first auxiliary material into the second material to obtain a first mixed material; Mixing a second auxiliary material into the first mixed material to obtain a second mixed material; The second mixed material is polymerized to obtain a compatibilizer.

3. The ablation device according to claim 2, characterized in that: The preset molecular weight is 1000-5000, the first material includes polyurethane, and the mass fraction of isocyanate in the first material is 5%-10%.

4. The ablation device according to claim 2, characterized in that: The step of preparing a first material having a preset molecular weight comprises: Take polyester polyol or polyether polyol, add diisocyanate at a first temperature and heat to a second temperature within a preset time to react to obtain the first material.

5. The ablation device according to claim 2, characterized in that: The method of performing end-capping treatment on the first material to obtain the second material comprises: adding an end-capping agent having an olefinic unsaturated bond to the first material and stirring the reaction for 15 to 30 minutes, wherein the end-capping agent comprises allyl polyether alcohol.

6. The ablation device according to claim 2, characterized in that: The first auxiliary material includes styrene, and mixing the first auxiliary material into the second material to obtain the first mixed material includes: adding styrene monomer to the second material, stirring and dissolving, and obtaining the uniformly mixed first mixed material.

7. The ablation device according to claim 2, characterized in that: The second auxiliary material includes azobisisobutyronitrile, and the second auxiliary material is uniformly mixed into the first mixed material to obtain the second mixed material, including: adding azobisisobutyronitrile to the first mixed material, and stirring and dissolving for 30 minutes to 40 minutes.

8. The ablation device according to claim 2, characterized in that: The step of polymerizing the second mixed material to obtain a compatibilizer comprises: Under nitrogen protection, the temperature is controlled at 75°C to 80°C, and the rotation speed is controlled at 150 rpm to 300 rpm, and the second mixture is polymerized for 4 to 5 hours.

9. The ablation device according to claim 1, characterized in that: The compatibilizer is prepared by the following method: preparing a first prepolymer having a hydroxyl group at the end, wherein the molecular structure of the first prepolymer includes a second segment; Adding diisocyanate to the first prepolymer to react to obtain a compatibilizer, Wherein, the molecular structure of the compatibilizer includes a first segment and a second segment.

10. The ablation device according to claim 9, characterized in that: The molecular structure of the compatibilizer includes an ABAB repeating structure, wherein A is the second segment, B is the first segment, the ABAB repeating structure is arranged in a zigzag shape, and A and B as end groups are respectively located on both sides of the central axis of the zigzag shape.

11. The ablation device according to claim 10, characterized in that: The first prepolymer having a hydroxyl group at the end is prepared, wherein the molecular structure of the first prepolymer includes a second segment, including: Dissolve styrene in a solvent, and add 1% to 5% by weight of bis(2-hydroxyethyl)-2,2′-azobisisobutyrate; Under nitrogen protection, in a constant temperature water bath, polymerizing for 0.5-2 hours to obtain the first prepolymer; Wherein, the molecular structure of the first prepolymer includes a HO-A-OH structure, and the second segment includes a polystyrene segment.

12. The ablation device according to claim 9, characterized in that: The step of adding diisocyanate to the first prepolymer to react and obtain a compatibilizer comprises: controlling the temperature of the first prepolymer to a first temperature, and adding the diisocyanate; The temperature is raised to a second temperature within a preset time to obtain the compatibilizer through reaction.

13. The ablation device according to claim 12, characterized in that: The method of adding diisocyanate to the first prepolymer to react and obtain a compatibilizer further comprises: Prior to adding the diisocyanate, the first prepolymer is dried.

14. The ablation device according to claim 12, characterized in that: The process of adding diisocyanate to the first prepolymer to react to obtain a compatibilizer also includes: degassing the compatibilizer.

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