A high-pressure resistant folded balloon and a manufacturing method thereof, and a balloon dilatation catheter

Abstract

The application relates to the field of medical intervention instruments and discloses a high-pressure-resistant folding balloon, a manufacturing method thereof and a balloon dilatation catheter. The balloon comprises a first elastic section and a second elastic section; a tube wall of the balloon is formed by at least the first elastic section and the second elastic section which are alternately distributed in the circumferential direction; and the elastic modulus of the first elastic section is greater than that of the second elastic section. The first elastic section provides rigid support, and the second elastic section provides elastic buffering to prevent rupture under high pressure, and the folding process is coordinated, so that the balloon as a whole can withstand higher pressure, and the requirement of dilating calcified or stenotic blood vessel lesions can be met; when the balloon is reset after pressure release, the second elastic section is folded and contracted to form a plurality of folding wings, the shape of the balloon changes regularly, the catheter sheath can be conveniently withdrawn, the harm caused by difficult withdrawal to a patient is avoided, the stress and deformation mode of the balloon are optimized, the pressure resistance and the withdrawal performance are considered, and more reliable intervention instruments can be provided for vascular intervention and other operations.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical intervention instruments, in particular to a high-pressure resistant folding balloon and a manufacturing method thereof, and a balloon dilatation catheter. BACKGROUND

[0002] When a clinician faces a calcified or severely stenotic lesion that is difficult to dilate, a balloon capable of bearing higher pressure is used to dilate the lesion. For ordinary balloons, it is difficult to dilate the lesion due to insufficient pressure, and after the pressure is increased, the ordinary balloon is difficult to maintain the state before being inflated, and the size of the balloon is irregular and larger when the balloon is retracted, which makes it difficult to retract the balloon, and the balloon cannot be retracted into the catheter sheath, causing unnecessary harm to the patient.

[0003] In related technologies, high-pressure balloons such as non-compliant PET balloons improve pressure resistance by using a single high-strength material PET, but still randomly shrink after pressure relief.

[0004] Therefore, the current balloon is difficult to dilate the blood vessel in the calcified / severely stenotic lesion due to insufficient pressure resistance, and has the defects of insufficient pressure resistance and difficulty in retraction after pressure relief: the shape of the balloon changes irregularly after pressure relief, and cannot be regularly contracted, making it difficult to retract the catheter sheath. SUMMARY

[0005] Therefore, the present application provides a high-pressure resistant folding balloon and a manufacturing method thereof, and a balloon dilatation catheter to solve the problems in the background art.

[0006] In a first aspect, the present application provides a high-pressure resistant folding balloon, the balloon comprising a first elastic segment and a second elastic segment, the first elastic segment and the second elastic segment being made of an elastic polymer material; at least the first elastic segment and the second elastic segment are alternately distributed in the circumferential direction to form the tube wall of the balloon, the elastic modulus of the first elastic segment being greater than that of the second elastic segment.

[0007] When the balloon is inflated, the first elastic segment and the second elastic segment can expand and spread; when the balloon is pressure relieved and reset, the first elastic segment and the second elastic segment contract, the second elastic segment folds and contracts before the first elastic segment, and a plurality of folding wings are formed.

[0008] Beneficial effects: The tube wall of the balloon is formed by alternately distributing high-molecular materials with more than two different elastic moduli in the circumferential direction, the first elastic section provides rigid support, and the second elastic section provides elastic buffering to prevent rupture under high pressure, and cooperates with the folding process, so that the balloon as a whole can withstand higher pressure, meet the needs of expanding calcified or stenotic vascular lesions; when the balloon resets after pressure release, the second elastic section first folds and shrinks to form multiple folding wings, so that the balloon shape changes regularly and the size is controllable, the withdrawal performance is improved, the catheter sheath is easily withdrawn, and the harm caused by difficult withdrawal to the patient is avoided. The present application optimizes the stress and deformation mode of the balloon, balances the pressure resistance and withdrawal performance, and can provide more reliable interventional instruments for vascular intervention and other surgeries.

[0009] In some embodiments, the total proportion of the first elastic section in the circumferential direction is independently set to 10%-90%; and the total proportion of the second elastic section in the circumferential direction is independently set to 10%-90%;

[0010] The difference between the elastic moduli of the first elastic section and the second elastic section is greater than or equal to 200MPa.

[0011] The elongation at break of the first elastic section and / or the second elastic section is greater than 200%.

[0012] In some embodiments, the elastic modulus of the first elastic section is greater than or equal to 500MPa, and the first elastic section is at least one of polyamide, polyethylene terephthalate, and high-density polyethylene.

[0013] The elastic modulus of the second elastic section is less than or equal to 300MPa, and the second elastic section is at least one of polyether block amide, low-density polyethylene, and polytetrafluoroethylene.

[0014] Beneficial effects: The first elastic section is a high-elasticity modulus material, such as polyamide, polyethylene terephthalate, and high-density polyethylene, which ensures that the balloon has sufficient pressure resistance to cope with calcified lesions or narrow locations; the second elastic section is a low-elasticity modulus material, such as polyether block amide, low-density polyethylene, and polytetrafluoroethylene, which ensures that the balloon has sufficient flexibility and fatigue resistance for smooth folding and shrinking.

[0015] In some embodiments, the total proportion of the first elastic section in the circumferential direction is less than or equal to the total proportion of the second elastic section in the circumferential direction.

[0016] Beneficial effects: In terms of total proportion in the circumferential direction, the first elastic section is less than the second elastic section, so that the low-elasticity modulus material section has a larger proportion, and has a greater shrinking force when pressure is released to drive the high-modulus section to fold inward regularly to form more compact folding wings, which is beneficial to reducing the withdrawal diameter. In terms of total proportion in the circumferential direction, the first elastic section is equal to the second elastic section, which can make the stress distribution of the balloon more uniform during expansion and contraction, reduce local stress concentration, and improve the stability of the structure.

[0017] In some embodiments, the radial wall thickness of the second elastic segment is not less than the radial wall thickness of the first elastic segment.

[0018] Beneficial effects: the radial wall thickness of the second elastic segment is not less than the first elastic segment, which can ensure the flexibility of the low elastic modulus material segment when folded, and also has certain strength to prevent excessive deformation or damage in a high pressure environment, enhance the structural strength and durability of the balloon, and prolong the service life of the balloon; through the wall thickness design, the strength deficiency of the low elastic modulus material is compensated for, the overall structural strength is improved on the basis of maintaining good folding performance, so as to adapt to the high pressure working environment.

[0019] In some embodiments, the radial wall thickness of the first elastic segment is independently set to 0.1-1.5mm; and the radial wall thickness of the second elastic segment is independently set to 0.1-1.5mm.

[0020] Beneficial effects: setting the wall thickness of the first elastic segment and the second elastic segment in the range of 0.1-1.5mm helps to accurately control the pressure resistance, flexibility and folding performance of the balloon, so that it better matches the clinical use requirements, and at the same time facilitates the production process to be realized.

[0021] In some embodiments, at least one of the surfaces of the first elastic segment is provided with a functional area, and the functional area is used to carry a cutting element or a drug coating.

[0022] Beneficial effects: the functional area on the surface of the first elastic segment can be used to carry a cutting element to assist in treating complex lesions such as vascular calcification, or to coat a drug coating to achieve local drug release and prevent complications such as vascular restenosis, thereby increasing the clinical application value of the product.

[0023] In a second aspect, the application also provides a manufacturing method of a high-pressure-resistant directional folding balloon, comprising:

[0024] At least two high molecular materials with different elastic moduli are formed into a tubular preform by extrusion molding, injection molding or additive manufacturing process; at least a first elastic segment and a second elastic segment are alternately distributed in the circumferential direction of the tube wall to form the tube wall of the balloon, and the elastic modulus of the first elastic segment is greater than that of the second elastic segment.

[0025] Beneficial effects: the balloon is made by common processes such as extrusion molding, injection molding or additive manufacturing, which can be flexibly selected according to the production scale and equipment conditions, easy to realize large-scale production, optimize manufacturing efficiency and reduce cost.

[0026] In a third aspect, the present application further provides a balloon dilatation catheter, comprising a lumen tube, an outer tube and the balloon as described above, the proximal end of the balloon is connected with the end of the outer tube, and the distal end of the balloon is connected with the distal end of the lumen tube.

[0027] Beneficial effects: the balloon is assembled with the lumen tube and the outer tube into the balloon dilatation catheter, forming a complete interventional instrument, which is convenient for doctors to operate and use, and improves the operation efficiency and safety.

[0028] In some embodiments, the balloon dilatation catheter is configured such that the second elastic section is retracted before the first elastic section when the balloon is folded and reset, and the retraction diameter of the balloon after being folded is 0.5-3.0 mm.

[0029] Beneficial effects: the retraction diameter range of the balloon after being folded and reset is determined, which has good retraction performance, and is convenient for doctors to preoperatively evaluate the applicability of the instrument and reduce the operation risk.

[0030] In some embodiments, the working pressure of the balloon dilatation catheter is ≥20 ATM, and the burst pressure is ≥26 ATM.

[0031] Beneficial effects: the working pressure and the burst pressure of the balloon dilatation catheter are determined, which ensures that the balloon dilatation catheter can stably operate in a high-pressure environment and reliably complete the blood vessel dilatation task, and guarantees the operation effect and safety. BRIEF DESCRIPTION OF DRAWINGS

[0032] In order to more clearly illustrate the technical solutions in the specific embodiments or prior art of the present application, the drawings needed in the following specific embodiment or prior art description will be briefly introduced. Obviously, the drawings in the following description are some embodiments of the present application, and other drawings can also be obtained by those skilled in the art without creative labor.

[0033] Figure 1 It is a schematic diagram of the balloon dilatation catheter of the embodiment of the present application;

[0034] Figure 2 It is a schematic diagram of the balloon dilatation catheter of the embodiment of the present application;

[0035] Figure 3 It is a cross-sectional schematic diagram of the pressure relief folding of the balloon of the embodiment of the present application;

[0036] Figure 4 It is a cross-sectional schematic diagram of one of the balloon embodiments of the embodiment of the present application;

[0037] Figure 5 It is a structural schematic diagram of one of the balloon embodiments of the embodiment of the present application;

[0038] Figure 6 A cross-sectional view of a balloon embodiment two of the present application;

[0039] Figure 7 A structural view of a balloon embodiment two of the present application;

[0040] Figure 8 A cross-sectional view of a balloon embodiment three of the present application;

[0041] Figure 9 A structural view of a balloon embodiment three of the present application;

[0042] BRIEF DESCRIPTION OF THE DRAWINGS

[0043] 101, inner lumen tube; 102, outer lumen tube; 103, balloon; 104, catheter seat;

[0044] 201, first support section; 202, first folding section; 203, second support section; 204, second folding section; 205, third support section; 206, third folding section;

[0045] 301, first connecting section; 302, second connecting section; 303, third connecting section; 304, fourth connecting section; 305, fifth connecting section; 306, sixth connecting section;

[0046] 401, first combined section; 402, second combined section; 403, third combined section; 404, fourth combined section; 405, fifth combined section; 406, sixth combined section;

[0047] 501, first connecting section; 502, second connecting section; 503, third connecting section; 504, fourth connecting section; 505, fifth connecting section; 506, sixth connecting section. DETAILED DESCRIPTION

[0048] In order to make the objects, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are some but not all of the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by a person of ordinary skill in the art without creative work fall within the protection scope of the present application.

[0049] The balloon in the related art has the defects of insufficient pressure resistance and difficulty in withdrawing after pressure relief in calcification / severe stenosis lesions, and is difficult to expand the blood vessel due to insufficient pressure resistance. After the balloon is relieved, the shape changes irregularly, cannot be regularly contracted, and the catheter sheath is difficult to withdraw.

[0050] The present application aims to provide a balloon and a balloon dilatation catheter with both pressure resistance and retraction performance to solve the problems of insufficient pressure resistance and difficult retraction.

[0051] Embodiments of the present application will be described below in conjunction with Figures 1 to 9

[0052] According to an embodiment of the present application, in a first aspect, a high-pressure resistant folding balloon is provided, which is adapted to deform adaptively under a filling pressure and to return to its original shape after the filling pressure is removed.

[0053] In the embodiment, the balloon comprises a first elastic segment and a second elastic segment, both of which are made of an elastic polymer material; the tube wall of the balloon is formed by the first elastic segment and the second elastic segment being alternately distributed in the circumferential direction; and the elastic modulus of the first elastic segment is greater than that of the second elastic segment.

[0054] When the balloon 103 is filled, the first elastic segment and the second elastic segment can expand and spread out; and when the balloon 103 is deflated, the first elastic segment and the second elastic segment contract, the second elastic segment folds and contracts first, and a plurality of folding wings are formed.

[0055] The high-pressure resistant folding balloon provided in the embodiment is formed by more than two polymer materials with different elastic moduli being alternately distributed in the circumferential direction, the first elastic segment provides rigid support, and the second elastic segment provides elastic buffering to prevent rupture under high pressure, and the folding process is coordinated, so that the balloon 103 as a whole can withstand higher pressure and meet the needs of expanding calcified or stenotic blood vessels; when the balloon 103 is deflated, the second elastic segment folds and contracts first to form a plurality of folding wings, so that the shape of the balloon 103 changes regularly and the size is controllable, the retraction performance is improved, the catheter sheath is easily withdrawn, and the harm caused by difficult retraction to the patient is avoided.

[0056] The present application optimizes the stress and deformation mode of the balloon 103, and takes into account the pressure resistance and retraction performance, so as to provide more reliable interventional instruments for vascular intervention and other operations.

[0057] In a preferred embodiment, the total proportion of the first elastic segment in the circumferential direction is independently set to 10%-90%; the total proportion of the second elastic segment in the circumferential direction is independently set to 10%-90%; the difference between the elastic moduli of the first elastic segment and the second elastic segment is greater than or equal to 200MPa; and the elongation at break of the first elastic segment and / or the second elastic segment is greater than 200%.

[0058] In a specific embodiment, the elastic modulus of the first elastic segment is greater than or equal to 500MPa, and the elastic modulus of the second elastic segment is less than or equal to 300MPa.

[0059] ​The first elastic section is a high-elasticity modulus material, such as polyamide (PA), polyethylene terephthalate (PET), and high-density polyethylene (HDPE), which ensures that the balloon 103 has sufficient pressure resistance to cope with calcified lesions or narrow locations; the second elastic section is a low-elasticity modulus material, such as polyether block amide (Pebax), low-density polyethylene (LDPE), and polytetrafluoroethylene (PTFE), which ensures that the balloon 103 has sufficient flexibility and fatigue resistance to facilitate smooth folding and contraction.

[0060] In an exemplary embodiment, referring to Figure 3 , the balloon 103 includes a first support section 201, a first folding section 202, a second support section 203, a second folding section 204, a third support section 205, and a third folding section 206 connected in sequence in the circumferential direction; the first support section 201, the second support section 203, and the third support section 205 are made of the same high-molecular material, and the first folding section 202, the second folding section 204, and the third folding section 206 are made of the same high-molecular material; the first support section 201, the second support section 203, and the third support section 205 are all first elastic sections, serving as the main framework part of the balloon 103, and the first folding section 202, the second folding section 204, and the third folding section 206 are all second elastic sections, serving as the flexible part of the balloon 103 that can form folding wings. Under the same conditions, when the balloon 103 is reset after pressure relief, the first folding section 202, the second folding section 204, and the third folding section 206 will fold and contract before the first support section 201, the second support section 203, and the third support section 205 due to the difference in flexibility under the action of negative pressure, achieving the effect of regular automatic folding.

[0061] In a specific embodiment, according to the different number of folding sections, the folding wings formed after the balloon is pressure relieved are arranged in three, four, or more.

[0062] In a specific embodiment, referring to Figure 4 and Figure 5 , the balloon 103 includes a first connecting section 301, a second connecting section 302, a third connecting section 303, a fourth connecting section 304, a fifth connecting section 305, and a sixth connecting section 306 connected in sequence in the circumferential direction; the first connecting section 301, the third connecting section 303, and the fifth connecting section 305 are made of polyamide (PA), and the second connecting section 302, the fourth connecting section 304, and the sixth connecting section 306 are made of polyether block amide (Pebax); the first to sixth connecting sections 306 can have the same circumferential proportion, i.e., the balloon 103 is equally divided into six parts in the circumferential direction; by alternating the use of different materials, the elastic modulus difference between adjacent connecting sections is utilized to improve the pressure resistance of the balloon.

[0063] In some embodiments, the circumferential total proportion of the first elastic segment is equal to the circumferential total proportion of the second elastic segment. In terms of the circumferential total proportion, the first elastic segment is equal to the second elastic segment, which can make the balloon 103 have a more uniform stress distribution during expansion and contraction, reduce local stress concentration, and improve structural stability.

[0064] In some embodiments, the circumferential total proportion of the first elastic segment is less than the circumferential total proportion of the second elastic segment. In terms of the circumferential total proportion, the first elastic segment is less than the second elastic segment, which makes the proportion of the low elastic modulus material segment larger, and can have a greater contraction force when pressure is released, to drive the high modulus segment to fold inward regularly, forming a more compact folded wing, which is beneficial to reducing the retraction diameter.

[0065] In a specific embodiment, referring to Figure 6 and Figure 7 , the balloon 103 includes a first combined segment 401, a second combined segment 402, a third combined segment 403, a fourth combined segment 404, a fifth combined segment 405, and a sixth combined segment 406 in sequence along the circumference; there are two or more polymer materials in the six combined segments, and the proportion of each combined segment can be different; for example, the first combined segment 401, the third combined segment 403, and the fifth combined segment 405 are all first elastic segments, and a high elastic modulus polymer material such as polydodecanolactam (PA12) is selected, and the second combined segment 402, the fourth combined segment 404, and the sixth combined segment 406 are all second elastic segments, and a low elastic modulus polymer material such as polyether block amide (Pebax) is selected.

[0066] In a specific embodiment, the circumferential total proportion of the first combined segment 401, the third combined segment 403, and the fifth combined segment 405 is 10%, and the proportion of each segment can be different; the circumferential total proportion of the second combined segment 402, the fourth combined segment 404, and the sixth combined segment 406 is 90%, and the proportion of each segment can be different.

[0067] In some embodiments, a functional area is provided on the surface of the first elastic segment, and the functional area is used to carry cutting elements or drug coatings. The functional area provided on the surface of the first elastic segment can be used to carry cutting elements to assist in treating complex lesions such as vascular calcification, or to coat drug coatings to achieve local drug release and prevent complications such as vascular restenosis, thereby increasing the clinical application value of the product. Among them, the functional area is a surface modification of the first elastic segment, and the cutting elements added can be blades, needles, etc., forming a cutting balloon; adding a drug coating can form a drug balloon.

[0068] In some embodiments, the radial wall thickness of the second elastic section is not less than the radial wall thickness of the first elastic section. The radial wall thickness of the second elastic section is not less than the first elastic section, which can ensure the flexibility of the low elastic modulus material section when folded, and also has a certain strength to prevent excessive deformation or damage in a high pressure environment, enhance the structural strength and durability of the balloon 103, and prolong the service life of the balloon 103; through the wall thickness design, the low elastic modulus material is compensated for the lack of strength, and the overall structural strength is improved on the basis of maintaining good folding performance, so as to adapt to the high pressure working environment.

[0069] In a specific embodiment, referring to Figure 8 With Figure 9 , the balloon 103 includes a first connecting section 501, a second connecting section 502, a third connecting section 503, a fourth connecting section 504, a fifth connecting section 505 and a sixth connecting section 506 connected in sequence in the circumferential direction. The six connecting sections can be made into blocks with different thicknesses by injection molding or 3D printing process, and the wall thickness of the balloon after being formed is also regularly different. When the balloon is under negative pressure, the position with thin wall thickness will contract first than the position with thick wall thickness, which can also form an automatic folding effect.

[0070] In some embodiments, the radial wall thickness of the first elastic section is independently set to 0.1-1.5mm; the radial wall thickness of the second elastic section is independently set to 0.1-1.5mm.

[0071] Setting the wall thickness of the first elastic section and the second elastic section in the range of 0.1-1.5mm can help to accurately control the pressure resistance, flexibility and folding performance of the balloon 103, so that it can better match the clinical use requirements, and at the same time facilitate the production process to be realized.

[0072] In further embodiments, the balloon further includes a third elastic section, the tube wall of the balloon is formed by the first elastic section, the second elastic section and the third elastic section alternately distributed in the circumferential direction, and the elastic modulus of the third elastic section is less than the elastic modulus of the second elastic section; when the balloon 103 is reset after pressure relief, all the elastic sections contract, the third elastic section folds and contracts first, and the second elastic section folds and contracts first. Of course, the balloon can also include more elastic sections with different elastic moduli.

[0073] According to the embodiments of the present application, the second aspect provides a manufacturing method of a high-pressure-resistant directional folding balloon, comprising:

[0074] At least two high molecular materials with different elastic moduli are formed into a tubular preform by extrusion molding, injection molding or additive manufacturing process; at least the first elastic section and the second elastic section are alternately distributed in the circumferential direction of the tube wall to form the tube wall of the balloon, and the elastic modulus of the first elastic section is greater than the elastic modulus of the second elastic section.

[0075] The balloon is made by extrusion molding, injection molding or additive manufacturing process, which can be flexibly selected according to the production scale and equipment conditions, easy to realize large-scale production, optimize manufacturing efficiency and reduce cost.

[0076] According to the third aspect of the embodiments of the present application, a balloon dilatation catheter is provided, referring to Figure 1 With Figure 2 , the balloon dilatation catheter comprises an inner lumen tube 101, an outer lumen tube 102 and a balloon 103, the proximal end of the balloon 103 is connected with the end of the outer lumen tube 102, and the distal end of the balloon 103 is connected with the distal end of the inner lumen tube 101. Wherein, the inner lumen tube 101 and the outer lumen tube 102 form a filling channel communicating with the inner cavity of the balloon 103.

[0077] The balloon 103 is assembled with the inner lumen tube 101 and the outer lumen tube 102 to form a balloon dilatation catheter, which forms a complete interventional instrument, is convenient for doctors to operate and use, and improves the operation efficiency and safety.

[0078] In one structural embodiment, the catheter seat 104 is further provided with a filling port and a guide wire port, the filling port is in communication with the filling channel, and the guide wire port is in communication with the inner lumen tube 101.

[0079] In some embodiments, when the balloon 103 is folded and reset, the second elastic section is contracted before the first elastic section, and the withdrawal diameter of the folded balloon 103 is 0.5-3.0mm. The withdrawal diameter of the folded and reset balloon 103 is in the range of 0.5-3.0mm, which has good withdrawal performance, is convenient for doctors to evaluate the applicability of the instrument before operation, and reduces the risk of operation.

[0080] In some embodiments, the working pressure of the balloon dilatation catheter is ≥20ATM, and the burst pressure is ≥26ATM. The standards of the working pressure and the burst pressure of the balloon dilatation catheter are clear, which ensures the stable operation of the balloon dilatation catheter in high pressure environment, reliably completes the blood vessel dilatation task, and guarantees the operation effect and safety.

[0081] Although the embodiments of the present application are described in conjunction with the drawings, various modifications and changes can be made by those skilled in the art without departing from the spirit and scope of the present application, and such modifications and changes fall within the scope defined by the appended claims.

Claims

1. A high-pressure resistant folding balloon, characterized in that: the balloon comprises a first elastic section and a second elastic section, both of which are made of an elastic polymer material; the tube wall of the balloon is formed by at least the first elastic section and the second elastic section alternately distributed in the circumferential direction, the elastic modulus of the first elastic section is greater than that of the second elastic section; wherein, when the balloon is inflated, the first elastic section and the second elastic section can expand and spread out; when the balloon is pressure relieved and reset, the first elastic section and the second elastic section contract, the second elastic section folds and contracts first, and a plurality of folding wings are formed; the total proportion of the first elastic section in the circumferential direction is independently set to 10%-90%; the total proportion of the second elastic section in the circumferential direction is independently set to 10%-90%; the difference between the elastic modulus of the first elastic section and the second elastic section is ≥200MPa; the elongation at break of the first elastic section and / or the second elastic section is >200%; the elastic modulus of the first elastic section is ≥500MPa, and the first elastic section is at least one of polyamide, polyethylene terephthalate, and high-density polyethylene; the elastic modulus of the second elastic section is ≤300MPa, and the second elastic section is at least one of polyether block amide, low-density polyethylene, and polytetrafluoroethylene; the total proportion of the first elastic section in the circumferential direction is less than or equal to the total proportion of the second elastic section in the circumferential direction; the radial wall thickness of the second elastic section is not less than the radial wall thickness of the first elastic section.

2. The high-pressure resistant folding balloon according to claim 1, characterized in that: the radial wall thickness of the first elastic section is independently set to 0.1-1.5mm; the radial wall thickness of the second elastic section is independently set to 0.1-1.5mm.

3. The high-pressure resistant folding balloon according to claim 1, characterized in that: at least one of the first elastic sections is provided with a functional area on the surface, and the functional area is used to carry cutting elements or drug coatings.

4. A method of manufacturing a high-pressure resistant, directionally folded balloon, characterized by, including: at least two polymer materials with different elastic moduli are formed into a tubular preform by extrusion molding, injection molding or additive manufacturing process; at least the first elastic section and the second elastic section are alternately distributed in the circumferential direction of the tube wall to form the tube wall of the balloon of claim 1, and the elastic modulus of the first elastic section is greater than that of the second elastic section.

5. A balloon dilatation catheter characterized by, including an inner lumen tube (101), an outer lumen tube (102), and the balloon (103) of any one of claims 1-4, the proximal end of the balloon (103) is connected to the end of the outer lumen tube (102), and the distal end of the balloon (103) is connected to the distal end of the inner lumen tube (101).

6. The balloon dilation catheter of claim 5, wherein, When the balloon expansion catheter is folded and reset, the second elastic section contracts first, and the retracted diameter of the balloon (103) after folding is 0.5-3.0mm; and / or; the working pressure of the balloon expansion catheter is ≥20ATM, and the burst pressure is ≥26ATM.

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