CN118058808A - Flexible substrate composite cutting balloon and preparation method thereof - Google Patents
Flexible substrate composite cutting balloon and preparation method thereof Download PDFInfo
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- CN118058808A CN118058808A CN202410227879.7A CN202410227879A CN118058808A CN 118058808 A CN118058808 A CN 118058808A CN 202410227879 A CN202410227879 A CN 202410227879A CN 118058808 A CN118058808 A CN 118058808A
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Abstract
The invention relates to the technical field of cutting balloons, and particularly discloses a flexible substrate composite cutting balloon which comprises a balloon outer layer, a balloon inner layer and a plurality of anti-bonding coating areas, wherein the anti-bonding coating areas are uniformly arranged along the outer surface of the balloon inner layer, the part, close to the periphery, of each anti-bonding coating area is covered by the balloon outer layer, and the rest parts are leaked; the balloon cutter device comprises a cutter seat fixed at the outer leakage part of the anti-adhesive coating area, and a cutter is fixed in the cutter seat; the protective housing structure, its both ends are the opening setting, are close to the inner of sacculus and fix on the sacculus inlayer of cutter seat periphery, and the outer is upwards uplifted, forms the side through the casing lateral wall and surrounds the cutter. The invention can hide and release the cutter by controlling the air pressure in the balloon and control the cutting depth of the tip of the cutter, thereby not only avoiding the damage to human body in the moving process of the cutting balloon, but also effectively adjusting the cutting depth according to the condition of the lesion area.
Description
Technical Field
The invention relates to the technical field of cutting balloons, in particular to a flexible substrate composite cutting balloon and a preparation method thereof.
Background
The cutting saccule is a saccule with special status in the coronary heart disease interventional therapy field, which tightly combines the micro-cutting technology with the traditional saccule dilating technology, and provides a brand new interventional therapy scheme for doctors. In the pretreatment process of the lesions, the application of the cutting saccule can accurately cut and remove the stenosis in the blood vessel, so that the subsequent interventional treatment scheme is more perfect and effective.
In the interventional treatment of coronary heart disease, dilating a stenosed vessel to restore blood flow is an essential step. Conventional metal stent implantation is one of the usual methods of expansion, however, the "interventional no-implant" technique is becoming a new trend for coronary heart disease treatment, as permanent implantation of a metal stent may cause complications such as thrombosis and restenosis. Cutting balloons are an excellent choice in this technique, which can effectively improve the condition of vascular stenosis by mechanically dilating and cutting the inside of the vessel, while avoiding the risks and side effects associated with permanent implants.
The cutting balloon is a special balloon and is used as a pretreatment measure in the interventional therapy of coronary heart disease. The surface longitudinal axis of the balloon is embedded with 3-4 blades with the height of about 0.2-0.3 mm at equal angles, and the blades can cut the intima and media of the lesion part when the balloon is expanded. Then, due to the squeezing action of the balloon during inflation, the proliferated intimal tissue within the stent is pushed out of the frame structure of the stent. Therefore, the cutting balloon has less damage to the vessel wall, and the inflammatory reaction of the vessel wall is light, so that the incidence rate of restenosis after operation can be reduced to about 15 percent.
In coronary interventions, the physician will deliver a guiding catheter to the coronary ostia to be dilated via the femoral or radial artery approach, and then deliver a correspondingly sized cutting balloon along the guiding wire to the stenosed segment. Then, according to the characteristics of the pathological changes, doctors can expand with proper pressure and time to achieve the purpose of relieving the stenosis. In cases where the stenosis is severe, the physician may first dilate the stenosed site with a balloon and then deliver the stented balloon to the stenosed site under the guidance of the guidewire. Then, the stent is released and tightly attached to the stenosis by the inflation pressurization of the pressure pump, thereby achieving the purposes of completely relieving the vascular stenosis and recovering the normal myocardial blood supply.
The existing cutting balloon body is of a single-layer structure and belongs to a non-compliant balloon, and a cutter is fixed on the surface of the cutting balloon to cut pathological tissues in a human body blood vessel and the like. In operation, the cutting depth of the cutter cannot be adjusted and controlled, so that the problems of incomplete cutting, scratching of the vascular wall of a human body and the like are easy to occur, and the operation risk is increased. Meanwhile, the situation that the cutting balloon scratches the vascular wall of a human body in the moving process often occurs, which is also a test for the operation technique of doctors, namely, the operation difficulty of the doctors is improved. In addition, the existing cutting balloon is limited by the structural reason of the existing cutting balloon, and when the atherosclerosis plaque in the blood vessel is cut, the risk that the cutter falls off also exists, on one hand, the contact area of the cutter and the balloon is small, the bonding effect is affected, and on the other hand, a corresponding cutter protection structure is not arranged, so that certain medical hidden danger exists.
Disclosure of Invention
Based on the above, the invention aims to overcome the defects in the prior art and provide a flexible substrate composite cutting balloon and a preparation method thereof.
In order to achieve the above purpose, the invention adopts the following technical scheme:
A flexible substrate composite cutting balloon comprises a balloon outer layer and a balloon inner layer;
The anti-bonding coating areas are uniformly arranged along the outer surface of the inner layer of the balloon, the part, close to the periphery, of each anti-bonding coating area is covered by the outer layer of the balloon, and the rest parts are leaked outwards;
the balloon cutter device comprises a cutter seat fixed at the outer leakage part of the anti-adhesive coating area, an inverted T-shaped groove structure is arranged in the cutter seat, the bottom end of a cutter is limited and fixed through the groove structure, and the tip end of the cutter is outwards arranged;
the protective housing structure, its both ends are the opening setting, are close to the inner of sacculus and fix on the sacculus inlayer of cutter seat periphery, and the outer is upwards uplifted, forms the side through the casing lateral wall and surrounds the cutter.
As a further improvement of the invention, the outer layer of the balloon is made of nylon or polyimide, the inner layer of the balloon is made of polyurethane or polyester, and the hardness and strength of the material of the outer layer of the balloon are larger than those of the inner layer of the balloon.
As a further improvement of the invention, the anti-bonding coating area is obtained by coating anti-bonding coating liquid through a spray coating/electrostatic adsorption/mechanical coating mode, and the anti-bonding coating liquid is prepared by mixing one or more of polytetrafluoroethylene, poly (perfluoroethylene propylene), poly (chlorotrifluoroethylene), polyvinylidene fluoride and perfluoroalkyl with one or more of tetrafluoroethylene copolymer and polyether ether ketone.
As a further improvement of the invention, the cutter tip comprises a cutting edge end and a supporting part, wherein the cutting edge end and the supporting part are exposed outside the cutter seat, the cutting edge angle alpha of the cutting edge end is more than or equal to 25 degrees and more than or equal to 10 degrees, and the enhanced supporting angle beta of the transition part between the supporting part and the cutting edge end is more than or equal to 170 degrees and more than or equal to 110 degrees.
As a further improvement of the invention, the side wall of the shell of the protective shell structure is of a uniform inward inclined structure; the opening at the outer end of the protective shell structure is used for allowing the cutter tip to come in and go out, and the size of the opening at the outer end is smaller than that of the cutter seat.
The preparation method of the flexible substrate composite cutting balloon comprises the following preparation steps:
1): selecting extrusion equipment and molding materials; polyurethane or polyester is used as an inner layer material, nylon or polyimide is used as an outer layer material, and one of polyoxymethylene, polytetrafluoroethylene and perfluoroethylene is used as an auxiliary molding material;
2): preparing an auxiliary molding material into a solid tube through extrusion equipment; simultaneously preparing PTFE emulsion for later use;
3): drying and dewatering the inner and outer layer materials to maintain the water content below 0.05%;
4): adding the inner layer material into a preheated extruder, and simultaneously penetrating out the solid tube from the machine head to perform inner layer cladding extrusion;
5): spraying/electrostatic adsorbing/mechanically brushing the prepared PTFE emulsion on the outer surface of the inner layer to form a plurality of anti-adhesion coating areas uniformly arranged along the outer surface of the inner layer, and performing quick drying treatment by using a drying tunnel after the spraying is finished;
6): performing outer layer cladding extrusion to obtain an original saccule blank, putting the original saccule blank into a water tank, cooling and shaping, and cutting the original saccule blank to a proper length;
7): placing the cut balloon raw material embryo into a die cavity of a balloon forming machine, so that the anti-bonding coating area is positioned at a relatively central position in the die cavity;
8): heating the balloon blank to 120-170 ℃, introducing compressed air into the balloon blank to raise the internal pressure of the balloon from 0.01MPa to 0.5MPa, enabling the balloon to be tightly attached to the inside of a cavity after being heated, keeping the set temperature, and cooling the forming die and the balloon blank after the internal pressure of the balloon reaches a constant state for 2-10min to shape the balloon blank;
9): taking out the semi-finished balloon and sealing one end of the balloon, and injecting clean liquid through the other end of the balloon to keep the balloon full;
10): heating a cutting tool specially customized according to the shape of the required anti-bonding coating area to 180-250 ℃, attaching the cutting tool to the surface of the outer layer of the balloon of the anti-bonding coating area, and cutting and stripping;
11): pre-folding the stripped saccule to ensure that the anti-adhesive coating area leaked outside after stripping is positioned below folds generated by folding;
12): ultrasonic cleaning is used for removing scattered anti-adhesion coating, drying is carried out after cleaning is finished, and a plasma mode is used for activating the dried balloon;
13): inflating the balloon, assembling the cutter and the cutter seat, adhering the cutter to the anti-adhesive coating area leaked from the stripping part in the step 10, and adhering the protective shell structure to the outer layer of the balloon on the periphery of the cutter seat;
14): releasing the gas in the saccule to shrink into a folded state, and carrying out heating shaping again to stabilize the folded state.
As a further improvement of the invention, the drying temperature in the step 5 is 80-140 ℃; the heat setting temperature in the step 14 is 60-120 ℃.
As a further improvement of the invention, the part of each anti-bonding coating area, which is close to the periphery, after cutting and peeling in the step 10 is covered by the outer layer of the balloon, and the rest parts are leaked; the shape of the anti-sticking coating area comprises one of a dot shape, a round shape, a square shape and an oval shape.
As a further improvement of the invention, the area of the anti-bonding coating area before inflation is 0.1mm minimum and 20mm maximum; the minimum thickness of the bond-preventing coating area before inflation is 0.001mm, and the maximum thickness is 0.02mm.
As a further improvement of the invention, the outer diameter of the prepared balloon raw material embryo is 0.5mm at the minimum and 8mm at the maximum; the balloon has the minimum outer diameter of 2mm and the maximum outer diameter of 32mm after inflation; the prepared balloon has the minimum length of 8mm and the maximum length of 80mm.
The beneficial effects of the invention are as follows:
1. The invention discloses a flexible substrate composite cutting balloon and a preparation method thereof, wherein the compliant balloon is improved and additionally arranged on the basis of a non-compliant balloon through structural and technological improvements, and a cutter can be hidden, released and the cutting depth of the tip of the cutter can be controlled by controlling the air pressure in the balloon, so that the damage to a human body in the moving process of the cutting balloon can be avoided, and the cutting depth can be effectively adjusted according to the condition of a lesion area.
2. The cutter is fixed on the inner layer and the anti-bonding coating area which are positioned in the protective shell structure and have lower hardness and strength by selecting different materials of the inner layer and the outer layer and the anti-bonding coating area and fixing the protective shell structure on the outer layer with higher hardness and strength, so that the relative position of the tip of the cutter can be adjusted by controlling the air pressure in the balloon.
3. In the cutting and peeling process of the outer layer of the balloon, the part, close to the periphery, of the anti-bonding coating area is kept to be covered by the outer layer of the balloon, so that the fixed part at the inner end of the protective shell structure is positioned on the inner layer, the anti-bonding coating area and the outer layer, and under the action of the anti-bonding coating area, the outer layer structure and the anti-bonding coating area are not completely fixed, so that a cutter seat on the leaked anti-bonding coating area is in a slightly floating state, and the cutter seat is more beneficial to extending and retracting in the protective shell structure. In addition, the deformation effect of the leakage-proof bonding coating area can be further ensured by pre-folding, shaping and the like of the balloon body.
4. By adding an activation treatment mode in the process steps, the fixing and bonding effect of the cutter seat and the anti-bonding coating area of the leakage part can be ensured, the cutter seat is relatively large in contact, and the bonding effect is good. In addition, the whole cutter is surrounded by the protective housing structure, and the contact bonding of its casing inner is more firm, and combines protective housing structure outer end opening size to be less than the cutter seat size, can directly avoid the cutter part to appear droing and leave over the risk in the blood vessel.
Drawings
In order to more clearly illustrate the embodiments of the invention or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described, it being obvious that the drawings in the following description are only some embodiments of the invention, and that other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
FIG. 1 is a schematic cross-sectional view of a cutting balloon blank tube according to the present invention.
Fig. 2 is a schematic view of the structure of the cutting balloon according to the present invention.
FIG. 3 is a cross-sectional view A-A of FIG. 2 in accordance with the present invention.
Fig. 4 is an enlarged view of the invention indicated by B in fig. 3.
Fig. 5 is a schematic view of a tool tip of the present invention.
FIG. 6 is a schematic diagram of a cutting balloon according to the present invention.
Fig. 7 is a schematic structural view of the balloon cutter device and the protective shell of the invention.
In the figure: the balloon comprises a balloon inner layer 1, an anti-bonding coating area 2, a balloon outer layer 3, a cutter seat 4, a cutter 5, a protective shell structure 6, an inverted T-shaped groove structure 41, a cutting edge end 51 and a supporting part 52.
Detailed Description
The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. It will be apparent that the described embodiments are only some, but not all, embodiments of the invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
As shown in fig. 1 to 7, a composite cutting balloon with a flexible substrate comprises an outer layer 3 and an inner layer 1 of the balloon, and a plurality of anti-adhesion coating areas 2, wherein the anti-adhesion coating areas 2 are uniformly arranged along the outer surface of the inner layer 1 of the balloon, and the part, close to the periphery, of each anti-adhesion coating area 2 is covered by the outer layer 3 of the balloon, and the rest parts are leaked. The saccule cutter device comprises a cutter seat 4 fixed at the outer leakage part of the anti-bonding coating area 2, wherein an inverted T-shaped groove structure 41 is arranged in the cutter seat 4, the bottom end of a cutter 5 is limited and fixed through the groove structure, namely, the bottom end of the cutter 5 is arranged into a T-shaped seat structure, and one end of the inverted T-shaped groove structure 41 penetrates and is fixed. Further, the tip of the cutter 5 is disposed outward. The protective shell structure 6 is further arranged, two ends of the protective shell structure are provided with openings, the inner ends close to the sacculus are fixed on the sacculus outer layer 3 on the periphery of the cutter seat 4, the outer ends are raised upwards, and side surrounding is formed on the cutter 5 through the side wall of the shell.
In a specific embodiment, further, the outer layer 3 of the balloon is made of nylon or polyimide, the inner layer 1 of the balloon is made of polyurethane or polyester, and the hardness and strength of the material of the outer layer 3 of the balloon are larger than those of the inner layer 1 of the balloon. The balloon outer layer 3 may be preferably made of ML21, peBax 7233, peBax6333, peBax25 2533 GRILAMID L25, VESTAMID L2101F, GRILAMID ELY60, etc., and the balloon inner layer 1 may be preferably made of POLYBLEND、CHRONOPRENE、Desmopan® 880A/B、Desmopan® 9370A、Estane® TPU TL-80D、Estane® MED 1074、OnFlex™ MED TPU 45D、OnFlex™ MED FG6-72D、Carbothane® 5320、Tecoflex® EG 80A, etc.
In a specific embodiment, the anti-adhesion coating area 2 is further obtained by coating an anti-adhesion coating liquid by spraying/electrostatic adsorption/mechanical brushing, wherein the anti-adhesion coating liquid is prepared by mixing one or more of polytetrafluoroethylene, poly (perfluoroethylene-propylene), poly (chlorotrifluoroethylene), polyvinylidene fluoride and perfluoro-alkyl with one or more of tetrafluoroethylene copolymer and polyether ether ketone.
In a specific embodiment, further, the tip of the cutter 5 comprises a cutting edge end 51 and a supporting part 52, and the cutting edge end 51 and the supporting part 52 are exposed outside the cutter seat 4, wherein the cutting edge angle alpha of the cutting edge end 51 is more than or equal to 25 degrees and more than or equal to 10 degrees, and the enhanced supporting angle beta of the transition part between the supporting part 52 and the cutting edge end 51 is more than or equal to 170 degrees and more than or equal to 110 degrees.
In a specific embodiment, further, the side wall of the shell of the protective shell structure 6 is in a uniform inward inclined structure; the opening at the outer end of the protective shell structure 6 is used for allowing the tip of the cutter 5 to go in and go out, and the size of the opening at the outer end is smaller than that of the cutter seat 4.
The preparation method of the flexible substrate composite cutting balloon comprises the following preparation steps:
1): selecting extrusion equipment and molding materials; polyurethane or polyester is used as an inner layer material, nylon or polyimide is used as an outer layer material, and one of polyoxymethylene, polytetrafluoroethylene and perfluoroethylene is used as an auxiliary molding material;
2): preparing an auxiliary molding material into a solid tube through extrusion equipment; simultaneously preparing PTFE emulsion for later use;
3): drying and dewatering the inner and outer layer materials to maintain the water content below 0.05%;
4): adding the inner layer material into a preheated extruder, and simultaneously penetrating out the solid tube from the machine head to perform inner layer cladding extrusion;
5): spraying/electrostatic adsorbing/mechanically brushing the prepared PTFE emulsion on the outer surface of the inner layer to form a plurality of anti-adhesion coating areas 2 which are uniformly arranged along the outer surface of the inner layer, and performing quick drying treatment by using a drying tunnel after the spraying is finished;
6): performing outer layer cladding extrusion to obtain an original saccule blank, putting the original saccule blank into a water tank, cooling and shaping, and cutting the original saccule blank to a proper length;
7): placing the cut saccule raw material embryo into a mould cavity of a saccule forming machine, so that the anti-bonding coating area 2 is positioned at a relatively central position in the mould cavity;
8): heating the balloon blank to 120-170 ℃, introducing compressed air into the balloon blank to raise the internal pressure of the balloon from 0.01MPa to 0.5MPa, enabling the balloon to be tightly attached to the inside of a cavity after being heated, keeping the set temperature, and cooling the forming die and the balloon blank after the internal pressure of the balloon reaches a constant state for 2-10min to shape the balloon blank;
9): taking out the semi-finished balloon and sealing one end of the balloon, and injecting clean liquid through the other end of the balloon to keep the balloon full;
10): heating a cutting tool specially customized according to the shape of the needed anti-bonding coating area 2 to 180-250 ℃, attaching the cutting tool to the surface of the balloon outer layer 3 of the anti-bonding coating area 2, and cutting and stripping; the cutting tool can be arc-shaped or annular-shaped and the like, the cutting edge of the cutting tool is sharp at the edge of the cutting tool, and the rest parts are smoothly arranged;
11): pre-folding the stripped saccule to ensure that the anti-adhesive coating area 2 which leaks outwards after stripping is positioned below folds generated by folding;
12): ultrasonic cleaning is used for removing scattered anti-adhesion coating, drying is carried out after cleaning is finished, and a plasma mode is used for activating the dried balloon; the wettability of the surface can be enhanced, and the subsequent bonding strength is improved;
13): inflating the balloon, assembling the cutter 5 and the cutter seat 4, bonding the cutter 5 and the cutter seat on the anti-bonding coating area 2 which is leaked outside at the stripping part in the step ten, and bonding the protective shell 6 on the balloon outer layer 3 at the periphery of the cutter seat 4; because cutter 5 and cutter seat 4 bond on sacculus inlayer 1 and anti-adhesion coating 2, protective housing structure 6 bonds on sacculus inlayer 3, and sacculus inlayer 1 adopts the flexible material, and its intensity, hardness are slightly less than sacculus inlayer 3 to the relative position of cutter 5 pointed end is adjusted to the size of accessible control sacculus inside atmospheric pressure, just has realized the adjustable of cutting depth. In addition, when entering the human body or exiting the human body, the cutter 5 can be completely hidden in the protective shell structure 6 by controlling the air pressure in the balloon;
14): releasing the gas in the saccule to shrink into a folded state, and carrying out heating shaping again to stabilize the folded state.
In a specific embodiment, further, the drying temperature in the fifth step is 80-140 ℃; the heat setting temperature in the fourteen steps is 60-120 ℃. In the step ten, the part, close to the periphery, of each anti-bonding coating area 2 after cutting and stripping is covered by the outer layer 3 of the balloon, and the rest parts are leaked outwards; the shape of the anti-adhesive coating area 2 includes one of a dot shape, a circular shape, a square shape, and an oval shape.
In a specific embodiment, further, the area of the bond preventing coating area 2 before inflation is a minimum of 0.1mm and a maximum of 20 mm; the minimum thickness of the bond preventing coating area 2 before inflation was 0.001mm, and the maximum thickness was 0.02mm. The outer diameter of the prepared saccule raw material embryo is 0.5mm at the minimum and 8mm at the maximum; the balloon has the minimum outer diameter of 2mm and the maximum outer diameter of 32mm after inflation; the prepared balloon has the minimum length of 8mm and the maximum length of 80mm.
The foregoing is a description of embodiments of the present application, and it should be noted that, for those skilled in the art, modifications and variations can be made without departing from the principles of the embodiments of the present application, and such modifications and variations are also considered to be within the scope of the present application.
Claims (10)
1. The flexible substrate composite cutting balloon is characterized by comprising a balloon outer layer and a balloon inner layer;
The anti-bonding coating areas are uniformly arranged along the outer surface of the inner layer of the balloon, the part, close to the periphery, of each anti-bonding coating area is covered by the outer layer of the balloon, and the rest parts are leaked outwards;
the balloon cutter device comprises a cutter seat fixed at the outer leakage part of the anti-adhesive coating area, an inverted T-shaped groove structure is arranged in the cutter seat, the bottom end of a cutter is limited and fixed through the groove structure, and the tip end of the cutter is outwards arranged;
the protective housing structure, its both ends are the opening setting, are close to the inner of sacculus and fix on the sacculus inlayer of cutter seat periphery, and the outer is upwards uplifted, forms the side through the casing lateral wall and surrounds the cutter.
2. The flexible substrate composite cutting balloon according to claim 1, wherein the outer layer of the balloon is made of nylon or polyimide, the inner layer of the balloon is made of polyurethane or polyester, and the hardness and strength of the material of the outer layer of the balloon are larger than those of the inner layer of the balloon.
3. The flexible substrate composite cutting balloon of claim 1, wherein the anti-adhesive coating area is obtained by coating an anti-adhesive coating liquid by spraying/electrostatic adsorption/mechanical brushing, and the anti-adhesive coating liquid is prepared by mixing one or more of polytetrafluoroethylene, poly (perfluoroethylene-propylene), poly (chlorotrifluoroethylene), poly (vinylidene fluoride) and perfluoro alkyl with one or more of tetrafluoroethylene copolymer and polyether ether ketone.
4. The flexible substrate composite cutting balloon of claim 1, wherein the cutter tip comprises a cutting edge end and a supporting portion, the cutting edge end and the supporting portion are exposed outside the cutter seat, wherein the cutting edge angle alpha of the cutting edge end is more than or equal to 25 degrees and more than or equal to 10 degrees, and the enhanced supporting angle beta of the transition part between the supporting portion and the cutting edge end is more than or equal to 170 degrees and more than or equal to 110 degrees.
5. The flexible substrate composite cutting balloon of claim 1, wherein the protective shell structure housing side walls are of a uniform inward sloping configuration; the opening at the outer end of the protective shell structure is used for allowing the cutter tip to come in and go out, and the size of the opening at the outer end is smaller than that of the cutter seat.
6. A method of preparing a flexible substrate composite cutting balloon according to any of claims 1 to 5, comprising the steps of:
1): selecting extrusion equipment and molding materials; polyurethane or polyester is used as an inner layer material, nylon or polyimide is used as an outer layer material, and one of polyoxymethylene, polytetrafluoroethylene and perfluoroethylene is used as an auxiliary molding material;
2): preparing an auxiliary molding material into a solid tube through extrusion equipment; simultaneously preparing PTFE emulsion for later use;
3): drying and dewatering the inner and outer layer materials to maintain the water content below 0.05%;
4): adding the inner layer material into a preheated extruder, and simultaneously penetrating out the solid tube from the machine head to perform inner layer cladding extrusion;
5): spraying/electrostatic adsorbing/mechanically brushing the prepared PTFE emulsion on the outer surface of the inner layer to form a plurality of anti-adhesion coating areas uniformly arranged along the outer surface of the inner layer, and performing quick drying treatment by using a drying tunnel after the spraying is finished;
6): performing outer layer cladding extrusion to obtain an original saccule blank, putting the original saccule blank into a water tank, cooling and shaping, and cutting the original saccule blank to a proper length;
7): placing the cut balloon raw material embryo into a die cavity of a balloon forming machine, so that the anti-bonding coating area is positioned at a relatively central position in the die cavity;
8): heating the balloon blank to 120-170 ℃, introducing compressed air into the balloon blank to raise the internal pressure of the balloon from 0.01MPa to 0.5MPa, enabling the balloon to be tightly attached to the inside of a cavity after being heated, keeping the set temperature, and cooling the forming die and the balloon blank after the internal pressure of the balloon reaches a constant state for 2-10min to shape the balloon blank;
9): taking out the semi-finished balloon and sealing one end of the balloon, and injecting clean liquid through the other end of the balloon to keep the balloon full;
10): heating a cutting tool specially customized according to the shape of the required anti-bonding coating area to 180-250 ℃, attaching the cutting tool to the surface of the outer layer of the balloon of the anti-bonding coating area, and cutting and stripping;
11): pre-folding the stripped saccule to ensure that the anti-adhesive coating area leaked outside after stripping is positioned below folds generated by folding;
12): ultrasonic cleaning is used for removing scattered anti-adhesion coating, drying is carried out after cleaning is finished, and a plasma mode is used for activating the dried balloon;
13): inflating the balloon, assembling the cutter and the cutter seat, adhering the cutter to the anti-adhesive coating area leaked from the stripping part in the step 10, and adhering the protective shell structure to the outer layer of the balloon on the periphery of the cutter seat;
14): releasing the gas in the saccule to shrink into a folded state, and carrying out heating shaping again to stabilize the folded state.
7. The method for preparing the flexible substrate composite cutting balloon according to claim 6, wherein the drying temperature in the step 5 is 80-140 ℃; the heat setting temperature in the step 14 is 60-120 ℃.
8. The method of manufacturing a composite cutting balloon with a flexible substrate according to claim 6, wherein the portion of each anti-adhesive coating area near the periphery after cutting and peeling in step 10 is covered by the outer layer of the balloon, and the remaining portion is leaked; the shape of the anti-sticking coating area comprises one of a dot shape, a round shape, a square shape and an oval shape.
9. The method of preparing a composite cutting balloon with a flexible substrate according to claim 6, wherein the area of the anti-bonding coating area before inflation is 0.1mm minimum and 20mm maximum; the minimum thickness of the bond-preventing coating area before inflation is 0.001mm, and the maximum thickness is 0.02mm.
10. The method for preparing the flexible substrate composite cutting balloon according to any one of claims 7 to 9, wherein the prepared raw material embryo of the balloon has the minimum outer diameter of 0.5mm and the maximum outer diameter of 8mm; the balloon has the minimum outer diameter of 2mm and the maximum outer diameter of 32mm after inflation; the prepared balloon has the minimum length of 8mm and the maximum length of 80mm.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202410227879.7A CN118058808A (en) | 2024-02-29 | 2024-02-29 | Flexible substrate composite cutting balloon and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202410227879.7A CN118058808A (en) | 2024-02-29 | 2024-02-29 | Flexible substrate composite cutting balloon and preparation method thereof |
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| Publication Number | Publication Date |
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| CN118058808A true CN118058808A (en) | 2024-05-24 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202410227879.7A Pending CN118058808A (en) | 2024-02-29 | 2024-02-29 | Flexible substrate composite cutting balloon and preparation method thereof |
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| Country | Link |
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| CN (1) | CN118058808A (en) |
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- 2024-02-29 CN CN202410227879.7A patent/CN118058808A/en active Pending
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