Disclosure of Invention
Objects of the present invention include, for example, providing a hydrophilic coating forming method and a balloon catheter, which can eliminate a viscous force between a valve and a flap after the balloon is folded into the flap.
Embodiments of the invention may be implemented as follows:
in a first aspect, the present invention provides a hydrophilic coating forming method for forming a hydrophilic coating on a balloon catheter surface, including the steps of:
applying pressure to the balloon catheter and maintaining the pressure to expand the balloon of the balloon catheter;
wrapping the balloon with a sealing film;
coating a hydrophilic coating liquid on the surface of the balloon catheter;
drying the balloon catheter;
and uncovering the sealing film.
In an alternative embodiment, the step of wrapping the balloon with a sealing film comprises:
determining the width dimension of the sealing film according to the length dimension of the balloon in the expanded state;
and winding the sealing film on the surface of the balloon.
In an alternative embodiment, the sealing film has a width dimension of 5mm to 50 mm.
In an alternative embodiment, the step of drying the balloon catheter comprises:
and drying the balloon catheter in an environment below 50 ℃.
In an alternative embodiment, the step of drying the balloon catheter comprises:
and drying the balloon catheter by using a drying box.
In an alternative embodiment, the balloon catheter is dried for 30-120 min.
In an optional embodiment, when the balloon catheter is dried, the humidity of the environment where the balloon catheter is located is 15% to 45%.
In an alternative embodiment, the step of applying pressure to the balloon catheter to inflate the balloon of the balloon catheter comprises:
applying pressure to the balloon catheter using a pressurizing device to gradually inflate the balloon;
closing a valve between the pressurizing device and the balloon catheter to stabilize the balloon in the inflated state.
In an alternative embodiment, the pressurizing device applies a pressure of 2atm to 6atm to the balloon catheter.
In an alternative embodiment, after the step of uncovering the sealing film, the method further comprises:
venting the balloon.
In a second aspect, the present invention provides a balloon catheter comprising a hydrophilic coating formed by the hydrophilic coating forming method according to any one of the preceding embodiments.
The beneficial effects of the embodiment of the invention include, for example:
the embodiment of the invention provides a hydrophilic coating forming method and a balloon catheter, wherein a balloon is expanded by applying pressure to the balloon catheter and maintaining the pressure. And then winding a sealing film on the surface of the balloon, so that the sealing film completely wraps the balloon to completely isolate the balloon from the outside. And then the hydrophilic coating liquid is coated on the surface of the balloon catheter, and the balloon is not touched by the hydrophilic coating liquid due to the isolation effect of the sealing film. And then, the balloon catheter is dried, and the balloon is decompressed, so that a hydrophilic coating is formed on the surface of the balloon catheter except the balloon, and after the balloon is folded in a split manner, viscous force does not exist between adjacent petals, the adverse phenomenon of tearing and blasting of the balloon is avoided, and medical accidents are avoided.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, but not all, embodiments of the present invention. The components of embodiments of the present invention generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations.
Thus, the following detailed description of the embodiments of the present invention, presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, it need not be further defined and explained in subsequent figures.
In the description of the present invention, it should be noted that if the terms "upper", "lower", "inside", "outside", etc. indicate an orientation or a positional relationship based on that shown in the drawings or that the product of the present invention is used as it is, this is only for convenience of description and simplification of the description, and it does not indicate or imply that the device or the element referred to must have a specific orientation, be constructed in a specific orientation, and be operated, and thus should not be construed as limiting the present invention.
Furthermore, the appearances of the terms "first," "second," and the like, if any, are used solely to distinguish one from another and are not to be construed as indicating or implying relative importance.
It should be noted that the features of the embodiments of the present invention may be combined with each other without conflict.
Interventional therapy is an emerging subject which is rapidly developed in recent years and integrates image diagnosis and clinical treatment, and is currently a clinical three-major-pillar subject which is parallel to traditional internal medicine and surgery. The device can be used for treating the lesion under the guidance and monitoring of digital subtraction angiography machines, CT, ultrasound, magnetic resonance and other imaging devices.
One currently used interventional therapy approach is to place a balloon catheter into the lesion of a patient, and inflate the balloon under a certain pressure to perform an expansion treatment on the lesion. For example, for coronary heart disease patients, with the aid of medical imaging equipment, a balloon catheter is inserted into a stenotic lesion of a blood vessel by using a skin puncture technique, and the balloon is inflated under a certain pressure, so that the stenotic lesion of the blood vessel is driven to expand, the lumen diameter of the blood vessel is restored to be normal, and the purpose of myocardial perfusion is improved. Or for a patient suffering from nasosinusitis, the balloon catheter is used for performing dilation treatment on a channel of a sinus, which is shrunk or blocked due to inflammation, so as to restore the sinus channel to a normal size. Can also be used for dilating patients with pathological changes due to obstruction of urethra and cystic duct.
The inventor researches and discovers that in the conventional balloon catheter, viscous force exists between adjacent valves after the balloon is folded into the valve sections. During interventional therapy by using the balloon catheter, the balloon can be rapidly expanded under external pressure, and the viscous force of the balloon needs to be overcome in the expansion process, so that the adverse phenomenon of tearing and blasting of the balloon can be caused, and medical accidents are caused. The reason for the viscous force exists, and the inventor finally proves that the existing balloon catheter is based on continuous calculation analysis and experiments, and in order to facilitate the balloon catheter to be placed in a lesion of a patient, a hydrophilic coating layer wrapping the balloon catheter is usually formed on the outer surface of the balloon catheter by using a hydrophilic coating liquid, the surface of the hydrophilic coating layer is soaked when the hydrophilic coating layer meets the liquid, so that the hydrophilic coating layer is activated to form colorless and transparent hydrogel which is highly lubricating and can bear repeated friction. However, the hydrophilic coating liquid has a certain viscosity, so that viscous force exists between adjacent lobes of the balloon.
In order to eliminate the viscous force between adjacent petals of the balloon, the inventor provides the following embodiments through research to improve the defects in the corresponding prior art, avoid the bad phenomenon caused by tearing and blasting the balloon, and avoid medical accidents.
Referring to fig. 1, an embodiment of the present invention provides a hydrophilic coating forming method for forming a hydrophilic coating 5 on a surface of a balloon catheter 100, including the steps of:
step S1: pressure is applied to the balloon catheter 100 to inflate the balloon 3 of the balloon catheter 100.
In this embodiment, a balloon catheter 100 as shown in fig. 2 is first provided, and the balloon catheter 100 includes a balloon 3, an outer tube 2 and an inner tube 1. The inner tube 1 has a first lumen 10 for passing a guide wire therethrough during an interventional procedure. The outer tube 2 is sleeved outside the inner tube 1, and a second tube cavity 20 is formed between the inner wall of the outer tube 2 and the outer wall of the inner tube 1. The balloon 3 is connected to the head end of the outer tube 2 and surrounds the inner tube 1, the head end of the balloon 3 is hermetically connected with the head end of the inner tube 1, for example, integrally formed or thermally fixed, and a third lumen 30 is formed between the inner wall of the balloon 3 and the outer wall of the inner tube 1, and the third lumen 30 is communicated with the second lumen 20. Wherein the tail end of the outer tube 2 is used for installing a pipe joint, and fluid can enter the third lumen 30 through the second lumen 20 under the action of the reinforcing device, so that the balloon 3 is gradually inflated along with the increase of the fluid in the third lumen 30.
In this step, a pressurizing device may be used to apply pressure to the balloon catheter 100, so that the balloon 3 is gradually inflated; the valve between the pressurizing means and the balloon catheter 100 is closed, stabilizing the balloon 3 in the inflated state.
Specifically, the balloon catheter 100 is inserted into the head end of the inner tube 1 by using a mandrel to fix the balloon 3, thereby facilitating the subsequent pressurizing operation. The tail end of the outer tube 2 is connected with a three-way valve through a luer connector, and the three-way valve is connected with an output port of a pressurizing device, so that a pressure supply route is formed. Wherein, the pressurizing device can adopt a pressure pump and can provide pressure. Luer connectors are common connections in the medical industry that greatly simplify the management of liquid and gaseous medical fluids. Connected by a male luer fitting and a mating female luer fitting. Either one of the male luer and the female luer is mounted on the rear end of the outer appearance, and correspondingly, the other one of the male luer and the female luer is connected with the three-way valve through a hose. The pressurizing device gradually inputs the gaseous fluid which does not react with the material phase of the balloon catheter 100 into the second lumen 20 through the luer connector and further flows into the third lumen 30, the balloon 3 is gradually expanded along with the elastic deformation, the three-way valve is rotated after the balloon is expanded to a certain degree, the passage between the pressurizing device and the balloon catheter 100 is closed, and the operation of the pressurizing device is stopped, so that the balloon 3 is stably in the expanded state.
Wherein the pressure range provided by the pressurizing device is 2 atm-6 atm. Where atm refers to standard atmospheric pressure. Of course, the specific pressure value is not limited in this embodiment, and may be any value between 2atm and 6atm, for example, 2atm, 3atm, 4atm, 5atm, 6atm, etc., depending on the actual required pressurization time.
Step S2: the balloon 3 is wrapped with a sealing film 4.
In this embodiment, the sealing film 4 is made of a material having water-proof and moisture-proof properties, and can effectively protect the anhydrous substance. Can be repeatedly folded for use, and can not be torn when being wound on an object with a sharp shape. The flexibility and softness can be correspondingly improved along with the temperature rise. Has good toughness and can generate elastic deformation. Meanwhile, the sealing tape has certain viscosity so as to realize seamless attachment with an object to be sealed and realize the purpose of sealing. For example, a rubber film, a plastic film, or the like may be used.
Referring to fig. 3, the sealing film 4 is used to wrap a layer around the surface of the balloon 3 to completely wrap the balloon 3. The width of the sealing film 4 is determined according to the length of the balloon 3 in the inflated state, and the sealing film 4 may be sufficient to completely wrap the balloon 3. For example, the length of the balloon 3 of the balloon catheter 100, which is commonly used at present, may be 5mm to 50mm, or may be 5mm, or 25mm or 50mm, or the like. The width of the sealing film 4 is adapted to the length of the balloon 3, that is, the width of the sealing film 4 is also in the range of 5mm to 50mm, and may be 5mm, 25mm, 50mm, or the like. The sealing film 4 can be manually wound on the surface of the balloon 3 to completely wrap the balloon 3, or the sealing film 4 can be wound on the surface of the balloon 3 by using an automatic device to completely wrap the balloon 3. Of course, in other embodiments, more than one layer, for example, two layers, three layers, four layers, etc., may be wound on the surface of the balloon 3 by using the sealing film 4 according to the winding requirement.
Step S3: the hydrophilic coating liquid is coated on the surface of the balloon catheter 100.
Specifically, the hydrophilic coating liquid may be applied to the surface of the balloon catheter 100 by dipping, microinjection, spraying, or the like. The dipping method is simple, complex equipment is not needed, only one container is needed, the hydrophilic coating liquid is placed in the container, the balloon catheter 100 is immersed in the hydrophilic coating liquid and then taken out, and the hydrophilic coating liquid can be coated on the surface of the balloon catheter 100. The microinjection method requires a micro syringe (microliter dose) to extract a certain amount of the hydrophilic coating liquid, and then injects the hydrophilic coating liquid onto the surface of the balloon catheter 100, so as to achieve the purpose of coating the hydrophilic coating liquid on the surface of the balloon catheter 100. The spraying method needs a sprayer, the hydrophilic coating liquid is loaded into the sprayer, and the hydrophilic coating liquid is sprayed on the surface of the balloon catheter 100 after being atomized by a spray head under the pressure action of the sprayer, so that the hydrophilic coating liquid can be coated on the surface of the balloon catheter 100. Of course, the above-mentioned manner is only a few exemplary illustrations, and does not limit the present embodiment, and the hydrophilic coating liquid may be coated on the surface of the balloon catheter 100 by using other coating methods commonly used in the art. The hydrophilic coating liquid can be a mixture of polyvinylpyrrolidone and an imide polymer.
After this step is performed, since the sealing film 4 is wound around the surface of the balloon 3 of the balloon catheter 100 and the sealing film 4 seals the balloon 3, the sealing film 4 has a function of isolating the balloon 3 from the hydrophilic coating liquid, and therefore, in the step of coating the hydrophilic coating liquid on the surface of the balloon catheter 100, the hydrophilic coating liquid does not adhere to the surface of the balloon 3 portion but adheres to the surface of the sealing film 4.
Step S4: drying the balloon catheter 100;
specifically, the sealing film 4 is softened and sticky to prevent the excessively high drying temperature from affecting the toughness of the sealing film 4. The balloon catheter 100 is thus dried in an environment below 50 ℃; in order to prevent moisture absorption of the cured hydrophilic coating 5 due to too high humidity during drying or cracking of the hydrophilic coating 5 due to too low humidity, it is desirable. Depending on the drying temperature and the humidity of the surrounding environment, the time for which the hydrophilic coating 5 is also cured to form the hydrophilic coating 5 may vary accordingly. For example, the balloon catheter 100 is dried by a drying device (e.g., a drying oven), the balloon catheter 100 is placed in the drying oven, the temperature in the drying oven is adjusted to 20 ℃ to 50 ℃, the ambient humidity is adjusted to 15% to 45%, and accordingly, the time required for drying is 30min to 120 min. Wherein, the drying temperature is 50 ℃, the humidity is 30%, which can ensure that the hydrophilic coating 5 formed by the solidification of the hydrophilic coating liquid can not absorb moisture and crack, and the required drying time is shortest. Of course, the above values and value ranges are exemplary illustrations, and this embodiment does not limit this, and the minimum value of 20 ℃ as the ambient temperature in the drying oven is only selected to prevent the curing time of the hydrophilic coating liquid from being too long, and those skilled in the art can select the temperature below 20 ℃ according to actual production requirements. In general, in this embodiment, the balloon catheter 100 may be dried at any temperature below 50 ℃ and any humidity between 15% and 45%, and accordingly, the required drying time is any time between 30min and 120min, 30min at 50 ℃ and 120min at 20 ℃ to solidify the hydrophilic coating liquid to form the hydrophilic coating 5. In other embodiments, the balloon catheter 100 may also be air-dried, so that the drying temperature and humidity are the temperature and humidity of the environment in which the balloon catheter 100 is located.
With reference to fig. 4, through the steps, the hydrophilic coating liquid on the surface of the balloon catheter 100 and the surface of the sealing film 4 can be cured to form the hydrophilic coating 5, the thickness of the hydrophilic coating 5 is within 5 μm, the hydrophilic coating 5 has good toughness, is not easy to be observed by naked eyes, and is soaked on the surface when encountering the liquid, so that the hydrophilic coating is activated to form colorless and transparent hydrogel which is highly lubricated and can bear repeated friction, so that the balloon catheter 100 can move in a human body, and the balloon catheter 100 can be conveniently placed in a lesion of the human body. Of course, due to the different properties of the selected sealing film 4, the corresponding drying temperature, the humidity in the drying box and the drying time can be adaptively adjusted by those skilled in the art, and are not limited in this embodiment.
S5: the sealing film 4 is peeled off.
Specifically, the sealing film 4 may be peeled off from the balloon 3 manually layer by layer, or the sealing film 4 may be peeled off by an automated apparatus. After this step, a balloon catheter 100 as shown in fig. 5 may be formed. Because sealing film 4 wraps up sacculus 3 completely, consequently can effectively guarantee that sacculus 3 can not be touched by hydrophilic coating liquid, thereby form hydrophilic coating 5 carrying out drying operation, and uncover sealing film 4 back, 3 surfaces of sacculus do not have hydrophilic coating 5, consequently folding 3 valving of sacculus, just do not have viscous force between adjacent lamella and the lamella yet, and because 3 surfaces of sacculus do not have hydrophilic coating 5, consequently the frictional force of sacculus 3 and pathological change department is great, can not produce relative slip, therefore can stop because of the bad phenomenon emergence of the sacculus 3 tear blasting, avoid medical accident.
S6: the balloon 3 is deflated.
Specifically, the connection between the male luer and the female luer is disconnected, and the valve of the three-way valve is rotated to disconnect the balloon catheter 100 from the pressurizing device, so that the gaseous fluid in the third lumen 30 and the second lumen 20 escapes to the outside, for example, air, through the luer, thereby depressurizing the balloon 3, and gradually deflating the balloon 3. Of course, the pressurizing device may also perform vacuum absorption to suck the fluid, thereby completing the pressure relief of the balloon 3.
In summary, according to the hydrophilic coating 5 forming method and the balloon catheter 100 of the embodiment of the present invention, the balloon 3 is inflated by applying pressure to the balloon catheter 100 and maintaining the pressure. And then the sealing film 4 is wound on the surface of the balloon 3, so that the sealing film 4 completely wraps the balloon 3 to completely isolate the balloon 3 from the outside. Then, the hydrophilic coating liquid is coated on the surface of the balloon catheter 100, and the balloon 3 is not touched by the hydrophilic coating liquid due to the isolation effect of the sealing film 4. Then, the balloon catheter 100 is dried, and the balloon 3 is decompressed, so that the hydrophilic coating 5 is formed on the surface of the balloon catheter 100 except the balloon 3, the lubricity of the balloon catheter 100 is facilitated, the balloon catheter is easy to place in a lesion, the balloon 3 is ensured to be folded in a split manner, no viscous force exists between adjacent petals, the bad phenomenon of tearing and blasting of the balloon 3 is avoided, and medical accidents are avoided. Moreover, because the surface of the balloon 3 of the existing balloon catheter 100 is covered with the hydrophilic coating 5, when the balloon 3 occasionally contacts with the wall of a diseased part along with the pulsation of the heart, the balloon 3 is easy to slide, which affects the normal operation of interventional therapy and can cause aggravation of the disease in serious cases.
The above description is only for the specific embodiments of the present invention, but the scope of the present invention is not limited thereto, and any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention are included in the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.