Novel medicine balloon device and using method

Abstract

The invention relates to the technical field of clinical drug balloons, in particular to a novel drug balloon device and a using method. The balloon catheter comprises a balloon, a catheter body and a connecting base, the balloon is installed at the front end of the catheter body and intervenes in a blood vessel for treatment, the balloon comprises an outer balloon body and an inner balloon body, the outer balloon body wraps the inner balloon body, a gap is formed between the outer balloon body and the inner balloon body, and medicine is stored in the gap formed between the outer balloon body and the inner balloon body. The balloon is used for puncturing into a blood vessel to perform expansion support treatment on a narrow part of the blood vessel, and is also used for conveying medicine to a blood vessel wall and treating the narrow part of the blood vessel and vascular hyperplasia, and the catheter is used for operating and controlling the balloon to move in the blood vessel, so that an operation doctor can perform an interventional operation conveniently; the outer balloon and the inner balloon are used for making contact with the blood vessel wall and controlling expansion respectively, operation is convenient, the expansion size is limited, operation errors are reduced, and the medicine can be stored conveniently through the gap interlayer between the outer balloon and the inner balloon and can be directly fed into the diseased position.

Description

Technical Field

[0001] The present invention relates to the technical field of clinical drug balloons, and in particular to a novel drug balloon device and a use method thereof. Background Art

[0002] For severe cardiovascular stenosis, drug therapy is sometimes difficult to control the symptoms of angina pectoris, and surgical treatment is finally necessary. In order to solve cardiovascular stenosis, the method currently used is mainly interventional treatment. Surgical drug balloon is a device widely used in interventional treatment.

[0003] The basic function of the drug-eluting balloon is the same as that of an ordinary balloon. First, the narrowed blood vessels are opened by mechanical expansion. After the balloon is introduced into the blood vessel, it is expanded by inflation, thereby compressing the blood vessel wall and restoring the patency of the blood vessel. During the expansion process, the surface of the drug-eluting balloon is coated with anti-proliferative drugs. When the balloon is inflated, these drugs will be released into the blood vessel wall and surrounding tissues. The purpose of drug release is to inhibit the proliferation of smooth muscle cells and reduce the risk of restenosis.

[0004] However, there are some technical problems with the drug-eluting balloons commonly used in clinical practice. These problems include the difficulty in accurately controlling the rate and total amount of drug release, which may lead to excessively high or low local drug concentrations. In addition, the use of drug-eluting balloons requires operators to have a high level of technical skills, and improper operation may lead to poor results or complications.

[0005] Among them, patent CN213158822U discloses a novel drug balloon catheter, including a catheter body, on which a needle seat, a catheter part, a balloon body and a catheter tip are connected in sequence from the proximal end to the distal end. The balloon body includes an outer balloon and an inner balloon. The drug coating is sprayed on the surface of the inner balloon, and the surface of the folded outer balloon is provided with a hydrophilic coating. At the same time, a plurality of micropores are provided on the surface of the outer balloon, wherein liquid needs to be perfused for drug delivery, which is difficult to operate. At the same time, the drug action time is short, which is not conducive to the drug being fully absorbed by the blood vessel wall, thereby reducing the treatment effect. Summary of the invention

[0006] In order to solve the problem of uneven drug release from a drug balloon and reduce the difficulty of using the drug balloon, the present invention provides a novel drug balloon device and a method of using the drug balloon.

[0007] On the one hand, the present invention provides a novel drug balloon device adopts the following technical solution:

[0008] A novel drug balloon device and a method of use, comprising a balloon, a catheter and a connecting seat, wherein the balloon is installed at the front end of the catheter and intervenes in the blood vessel for treatment, and the connecting seat is installed at the rear end of the catheter and manipulates the balloon and the catheter to intervene in the blood vessel outside the body to reach the treatment position, and the balloon comprises an outer balloon and an inner balloon, wherein the outer balloon is wrapped around the outside of the inner balloon and a gap is formed between the outer balloon and the inner balloon, and drugs are stored in the gap formed between the outer balloon and the inner balloon, and the therapeutic drugs are released toward the blood vessel wall by supporting or expanding the inner balloon.

[0009] The balloon is used to puncture into the blood vessel to expand and support the stenosis of the blood vessel, and is also used to deliver drugs to the blood vessel wall to treat vascular stenosis and vascular hyperplasia. The catheter is used to operate and control the movement of the balloon in the blood vessel and cooperate with the connecting seat to perform surgical operations, making it easier for the doctor to perform interventional surgery. The outer balloon and the inner balloon are used to contact the blood vessel wall and control expansion respectively, which facilitates operation and limits the size of expansion, reducing surgical errors. The gap between the outer balloon and the inner balloon is convenient for storing drugs, which is conducive to delivering drugs directly to the diseased area.

[0010] Furthermore, the outer balloon is provided with a drug delivery hole, and the drug flows out from the drug delivery hole and is released onto the blood vessel wall that needs to be treated. The end of the inner balloon is connected to the outer balloon through a connecting joint and controls the fixed or rotating state of the inner balloon.

[0011] The drug delivery hole is used to transport drugs from the inside of the balloon to the outside, reducing drug loss when the balloon moves in the blood vessel, and facilitating the drug to act evenly on the blood vessel wall. The connecting joint is used to connect the outer balloon and the inner balloon, which is convenient for fixing the position between the outer balloon and the inner balloon and facilitating the control and fixation of the inner balloon.

[0012] Furthermore, the drug delivery hole includes a dialysis through hole, which penetrates the outer balloon and connects the gap between the outer balloon and the inner balloon and the external space of the outer balloon, and releases the drug in the gap between the outer balloon and the inner balloon onto the blood vessel wall through the dialysis through hole.

[0013] The dialysis through hole is conducive to slowly releasing the drug into the blood vessel wall, thereby enhancing the effect of the drug on the blood vessel wall.

[0014] Furthermore, the drug delivery hole includes a hollow through hole, which is evenly arranged and independently opened on the outer balloon, an outer micro blind hole is opened on the outer surface of the outer balloon, and an inner micro blind hole is opened on the outer surface of the inner balloon, the drug stored in the outer micro blind hole is directly released onto the blood vessel wall, and the drug stored in the inner micro blind hole is released onto the blood vessel wall through the hollow through hole, and a blood through hole is physically opened at the gap between the hollow through holes of the outer balloon, and the blood in the blood vessel flows through the blood through hole at both ends of the outer balloon blockage.

[0015] The hollow through holes facilitate the direct large-area drug action on the blood vessel wall, and the hollow through holes form a closed space, which is conducive to the long-term action of the drug on the blood vessel wall and improves the drug effect. The outer micro-blind holes and the inner micro-blind holes are used for applying and storing drugs in advance, which is convenient for delivering drugs into blood vessels, eliminating the step of injecting drugs, facilitating operation and reducing drug delivery costs. The blood through holes are used to allow blood to pass through, which is conducive to keeping the airbag in the blood vessel for a long time, improving the drug action time and avoiding the side effect of long-term blockage of blood vessels.

[0016] Furthermore, the outer balloon is coated with a surface coating, which protects the drug from attaching to the outer balloon and / or assists in releasing and fixing the drug to the surface of the blood vessel wall. The surface coating that protects the drug from attaching to the outer balloon includes a hydrophobic coating, and the surface coating that assists in releasing and fixing the drug to the surface of the blood vessel wall includes a releasing agent and an adhesive.

[0017] Surface coating is used to protect drugs and reduce drug loss caused by friction between the outer balloon and the blood vessel wall when passing through the blood vessel. It is also helpful to fix the drugs on the blood vessel wall and increase the time the drugs act on the blood vessel wall. Hydrophobic coating is used to reduce drug loss caused by blood scouring during intravascular delivery. Release agents and adhesives are used to increase the drug release rate and increase the time the drugs adhere to the blood vessel wall.

[0018] Furthermore, the connecting joint includes a fixed joint or a rotating joint, the fixed joint connects the outer balloon and the inner balloon and fixes them to each other, and the rotating joint connects the nested outer balloon and the inner balloon and assists the inner balloon to rotate relative to the outer balloon.

[0019] The fixed joint is used to fix the outer balloon and the inner balloon, and to prevent the outer balloon and the inner balloon from being displaced relative to each other. The rotating joint facilitates the outer balloon and the inner balloon to rotate relative to each other, and is convenient for operating the outer balloon or the inner balloon to rotate and act on the blood vessel wall.

[0020] Furthermore, a cutting structure is provided on the outer surface of the inner balloon, and the cutting structure includes a protruding airbag and an air hole. One side of the protruding airbag is installed on the outer surface of the inner balloon and connected to the inner cavity of the inner balloon through the air hole, and the other side of the protruding airbag is wedge-shaped and expands outward to squeeze the blood vessel wall.

[0021] The cutting structure is used to cut the calcified plaque on the blood vessel wall, which facilitates the cleaning of the calcified plaque and improves the treatment effect. The cutting is performed by inflating the protruding airbag, which facilitates the control of the cutting and the cutting force, thereby reducing damage to the blood vessel wall.

[0022] Furthermore, the drugs released from the outer balloon and the inner balloon are mixed in a drug-carrying matrix, which drives the drug transport and release and adheres to the blood vessel wall. The drug-carrying matrix includes a hydrophilic matrix, a stabilizer and a solvent, and the drug and the drug-carrying matrix are micronized and dissolved.

[0023] The drug-loaded matrix is ​​used to carry and fix the drug, further reducing drug shedding and premature release. The hydrophilic matrix, stabilizer and solvent can effectively fix the drug and help increase the drug release rate, acting on the blood vessel wall for a long time, improving the treatment effect and reducing the recurrence of the disease.

[0024] Furthermore, the catheter is connected to and installed with an injection tube near the connecting seat, and the injection tube injects the drug along the catheter into the gap between the outer balloon and the inner balloon. A control tube is arranged in the catheter, and the control tube connects the inner balloon and the connecting seat and connects the inner balloon and the inflation device.

[0025] The injection tube is used to inject drugs and release the drugs into the blood vessel wall in cooperation with the expansion of the inner balloon. The control tube controls the rotation and inflation of the inner balloon.

[0026] On the other hand, the present invention provides a novel method for using a drug balloon device using the following technical solution:

[0027] A novel method for using a drug balloon device includes the following methods and steps:

[0028] The balloon and the catheter are punctured into the blood vessel under the control of the connecting seat and reach the lesion position along the blood vessel;

[0029] The outer balloon and the inner balloon are inflated to prop up the narrowed blood vessel, the inner balloon actively expands to prop up the outer balloon, and the outer balloon limits the expansion size of the inner balloon;

[0030] The drugs carried by the outer balloon and the inner balloon are released onto the blood vessel wall, and the inner balloon is further expanded and squeezed to accelerate the release of the drugs carried by the outer balloon and the inner balloon onto the blood vessel wall;

[0031] The outer balloon and the inner balloon are deflated and then withdrawn along the blood vessel and finally removed from the blood vessel.

[0032] The outer and inner balloons are inflated to effectively increase the diameter of the blood vessels and effectively treat vascular stenosis. The drugs on the outer and inner balloons are used to slow down and treat the proliferation of the blood vessel walls, reduce the recurrence of the disease, reduce surgical risks and improve the treatment effect.

[0033] In summary, the present invention has the following beneficial technical effects:

[0034] 1. The balloon is used to puncture into the blood vessel to expand and support the stenosis of the blood vessel, and is also used to deliver drugs to the blood vessel wall to treat vascular stenosis and vascular hyperplasia. The catheter is used to operate and control the movement of the balloon in the blood vessel and cooperate with the connecting seat for surgical operations, which is convenient for the doctor to perform interventional surgery. The outer balloon and the inner balloon are used to contact the blood vessel wall and control the expansion respectively, which is convenient for operation and limits the expansion size, reducing surgical errors. The gap between the outer balloon and the inner balloon is convenient for storing drugs, which is conducive to delivering drugs directly to the diseased area.

[0035] 2. The drug delivery hole is used to transport drugs from the inside of the balloon to the outside, reducing drug loss when the balloon moves in the blood vessel, and facilitating the drug to act evenly on the blood vessel wall. The connecting joint is used to connect the outer balloon and the inner balloon, which is convenient for fixing the position between the outer balloon and the inner balloon and facilitating the control and fixation of the inner balloon. The dialysis through hole is conducive to slowly releasing the drug to the blood vessel wall and improving the effect of the drug on the blood vessel wall.

[0036] 3. The hollow through holes facilitate the direct large-area drug action on the blood vessel wall, and the hollow through holes form a closed space, which is conducive to the long-term action of the drug on the blood vessel wall and improves the effect of the drug. The outer micro-blind holes and the inner micro-blind holes are used to apply and store the drug in advance, which is convenient for delivering the drug into the blood vessel, eliminating the step of injecting the drug, facilitating operation and reducing the cost of drug delivery. The blood through hole is used to allow blood to pass through, which is conducive to keeping the airbag in the blood vessel for a long time, improving the drug action time and avoiding the side effect of long-term blockage of the blood vessel.

[0037] 4. Surface coating is used to protect drugs and reduce drug loss caused by friction between the outer balloon and the blood vessel wall when passing through the blood vessel. It is also helpful to fix the drugs on the blood vessel wall and increase the time the drugs act on the blood vessel wall. Hydrophobic coating is used to reduce drug loss caused by blood scouring during intravascular delivery. Release agents and adhesives are used to increase the drug release rate and increase the time the drugs adhere to the blood vessel wall.

[0038] 5. The fixing section is used to fix the outer balloon and the inner balloon, and to place the outer balloon and the inner balloon in a displaced manner relative to each other. The rotating section facilitates the outer balloon and the inner balloon to rotate relative to each other, and is convenient for operating the outer balloon or the inner balloon to rotate and act on the blood vessel wall. The cutting structure is used to cut the calcified plaque on the blood vessel wall, which is convenient for cleaning the calcified plaque and improving the treatment effect. Cutting is performed by inflating the protruding airbag, which is convenient for controlling the cutting and cutting force, and reducing damage to the blood vessel wall.

[0039] 6. The drug-loaded matrix is ​​used to carry and fix the drug, further reducing drug shedding and premature release. The hydrophilic matrix, stabilizer and solvent can effectively fix the drug and help increase the drug release rate. It can act on the blood vessel wall for a long time, improve the treatment effect and reduce the recurrence of the disease. The injection tube is used to inject the drug and release the drug to the blood vessel wall in conjunction with the expansion of the inner balloon. The control tube controls the rotation and inflation of the inner balloon.

[0040] 7. The outer and inner balloons are inflated to effectively increase the diameter of the blood vessels and effectively treat vascular stenosis. The drugs on the outer and inner balloons are used to slow down and treat the proliferation of the blood vessel walls, reduce the recurrence of the disease, reduce surgical risks and improve the treatment effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] Figure 1 This is a schematic diagram of the structure of Embodiment 1 of the present invention;

[0042] Figure 2 This is a schematic diagram of the structure of Embodiment 2 of the present invention;

[0043] Figure 3 This is a schematic diagram of the structure of Embodiment 3 of the present invention;

[0044] Figure 4 This is a schematic diagram of the structure of Example 4 of the present invention.

[0045] Description of reference numerals:

[0046] Figure 1 The double-dotted circle in the figure is a partially enlarged schematic diagram of the cross-sectional structure of the outer balloon wall;

[0047] Figure 2 The middle dotted circle is a partially enlarged schematic diagram of the cross-sectional structure of the balloon, and the double-dotted circle is a partially enlarged schematic diagram of the cross-sectional structure of the outer balloon wall;

[0048] Figure 3 The middle dotted circle is a partially enlarged schematic diagram of the cross-sectional structure of the balloon, and the double-dotted circle is a partially enlarged schematic diagram of the cross-sectional structure of the outer balloon wall;

[0049] Figure 4 The middle dotted circle is a partial enlarged schematic diagram of the balloon surface structure, and the double-dotted circle is a partial enlarged schematic diagram of the cross-sectional structure of the outer balloon and inner balloon wall;

[0050] 1. Balloon, 11. Outer balloon, 1111. Dialysis through hole, 1112. Outer micro blind hole, 1113. Hollow through hole, 112. Blood through hole, 1131. Hydrophobic coating, 1132. Release agent, 1133. Adhesive, 12. Inner balloon, 1211. Fixed joint, 1212. Rotating joint, 122. Inner micro blind hole, 123. Cutting structure, 1231. Protruding airbag, 1232. Air hole, 2. Catheter, 21. Injection tube, 22. Control tube, 3. Connecting seat. DETAILED DESCRIPTION

[0051] The following will be combined with the attached Figure 1-Figure 4, the technical solutions in the embodiments of the present invention are clearly and completely described. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0052] In the description of the present invention, it should be understood that the terms "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside" and "outside" etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present invention.

[0053] Embodiment 1:

[0054] The present invention discloses a novel drug balloon device, referring to Figure 1 , including a balloon 1, a catheter 2 and a connecting seat 3, wherein the balloon 1 is installed at the front end of the catheter 2 and intervenes in the blood vessel for treatment, and the connecting seat 3 is installed at the rear end of the catheter 2 and manipulates the balloon 1 and the catheter 2 to intervene in the blood vessel to reach the treatment position outside the body, and the balloon 1 includes an outer balloon 11 and an inner balloon 12, wherein the outer balloon 11 is wrapped around the outside of the inner balloon 12 and a gap is formed between the outer balloon 11 and the inner balloon 12, and drugs are stored in the gap formed between the outer balloon 11 and the inner balloon 12, and the therapeutic drugs are released to the blood vessel wall by the support or expansion of the inner balloon 12.

[0055] Preferred drugs for treating angiogenesis include any one of macrolide immunosuppressants, paclitaxel, cyclosporine, gingerol, losartan, daidzein, docetaxel, dexamethasone, methotrexate, dextran, mitomycin, heparin sodium, doxorubicin hydrochloride, hirudin, argatroban, dipyridamole, prostacyclin, prostacyclin analogs, nitroglycerin, nitroprusside, suramin, endostatin, serotonin blockers, steroids or oligopeptides, or a combination of at least two thereof.

[0056] Reference Figure 1 The outer balloon 11 is provided with a drug delivery hole, and the drug flows out from the drug delivery hole and is released onto the blood vessel wall that needs to be treated. The end of the inner balloon 12 is connected to the outer balloon 11 through a connecting joint and controls the fixed or rotating state of the inner balloon 12.

[0057] Reference Figure 1The drug delivery hole includes a dialysis through hole 1111, which penetrates the outer balloon 11 and connects the gap between the outer balloon 11 and the inner balloon 12 and the external space of the outer balloon 11, and releases the drug in the gap between the outer balloon 11 and the inner balloon 12 onto the blood vessel wall through the dialysis through hole 1111.

[0058] Reference Figure 1 The outer side of the outer balloon 11 is coated with a surface coating, and the surface coating protects the drug from being attached to the outer balloon 11 . The surface coating that protects the drug from being attached to the outer balloon 11 includes a hydrophobic coating 1131 .

[0059] Reference Figure 1 The connecting section includes a fixing section 1211, and the fixing section 1211 connects the outer balloon 11 and the inner balloon 12 and fixes them to each other.

[0060] Reference Figure 1 The drugs released from the outer balloon 11 and the inner balloon 12 are mixed in the drug-carrying matrix, and the drug-carrying matrix drives the drug to be transported and released and adheres to the blood vessel wall. The drug-carrying matrix includes a hydrophilic matrix, a stabilizer and a solvent. The drug and the drug-carrying matrix are micronized and dissolved.

[0061] Preferably, the drug-carrying matrix is ​​a hydrophilic drug-carrying matrix, such as iopromide.

[0062] Good solvents for pharmaceutically active ingredients include one or more of ethanol, methanol, isopropanol, tetrahydrofuran, ethyl acetate, acetonitrile, chloroform, and acetone.

[0063] There are two ways to carry out drug coating operation:

[0064] 1. The drug and drug-loaded matrix are micronized by air flow milling method to form nano-scale crystals, stabilizers are added to stabilize the crystal morphology, and dissolved in a benign solvent. The micro-pressurized balloon is immersed in the drug solution, and the drug solution is immersed in the gap between the inner and outer balloons through the dialysis pores. The balloon is then dried, so that the drug can be loaded into the chambers in the inner and outer balloons.

[0065] 2. Microneedles are used to deliver drugs between the inner and outer chambers of the balloon. To ensure the uniformity of the drugs, high-speed uniform rotation and cooling are performed simultaneously to allow the drug solution to quickly precipitate crystals.

[0066] After the balloon 1 is pressurized, the outer protective layer ruptures, and a channel is formed between the chamber and the outside through the dialysis through hole 1111. Blood penetrates into the chamber, brings out the drug and releases it. To ensure the release effect, a hydrophilic drug-carrying matrix is ​​selected, which can better bring out the drug. At the same time, the inner balloon 12 is a compliant balloon, and the outer balloon 11 is a semi-compliant balloon. The inner balloon 12 will squeeze the outer balloon 11, which can ensure the full release of the drug in the chamber. At the same time, because the drug is evenly distributed in the chamber, it can ensure that the inner wall of each blood vessel receives the drug evenly.

[0067] The double-layer balloons on the market are used by infusing drugs. This method has great difficulties in use. Doctors are required to infuse the prepared liquid drugs through the infusion seat. Doctors need to prepare and use the drugs, which is equivalent to increasing the difficulty of the operation. Secondly, it is impossible to accurately deliver a certain amount of drugs according to the conditions of the blood vessels. For example, the current clinically effective drug dose is 3ug / mm2. During the infusion process, the drugs will definitely cause residues or other waste in the slender delivery lumen, resulting in the doctor's inability to accurately control the infusion volume to ensure that both the use effect can be achieved and the toxins are not generated. In addition, different blood vessel conditions require different infusion volumes, which makes it very difficult to use. The present invention can avoid this problem. According to the needs of the blood vessels, balloons 1 suitable for various specifications can be directly produced, and the drug dose can be controlled in advance. When using it, the doctor only needs to use it in the same way as ordinary drug balloons.

[0068] Because the perfusion method is used, the liquid flows from one end to the other end. During the flow, it will also seep out through the dialysis pores, resulting in uneven drug delivery to the blood vessels. This product is coated in advance to prepare a uniform drug coating, so that the drug can be evenly output through the dialysis pores.

[0069] The invention solves a key problem that the double-layer drug perfusion balloon is difficult to realize. Currently, liquid drugs are perfused through the perfusion port after being pressurized. However, the common drug on the market is paclitaxel, and the soluble liquid of paclitaxel is an organic solvent, which cannot be perfused into the body. Therefore, it is difficult to inject the drug directly into the human body through perfusion.

[0070] Embodiment 2:

[0071] The present invention discloses a novel drug balloon device, referring to Figure 2, including a balloon 1, a catheter 2 and a connecting seat 3, wherein the balloon 1 is installed at the front end of the catheter 2 and intervenes in the blood vessel for treatment, and the connecting seat 3 is installed at the rear end of the catheter 2 and manipulates the balloon 1 and the catheter 2 to intervene in the blood vessel to reach the treatment position outside the body, and the balloon 1 includes an outer balloon 11 and an inner balloon 12, wherein the outer balloon 11 is wrapped around the outside of the inner balloon 12 and a gap is formed between the outer balloon 11 and the inner balloon 12, and drugs are stored in the gap formed between the outer balloon 11 and the inner balloon 12, and the therapeutic drugs are released to the blood vessel wall by the support or expansion of the inner balloon 12.

[0072] Reference Figure 2 The outer balloon 11 is provided with a drug delivery hole, and the drug flows out from the drug delivery hole and is released onto the blood vessel wall that needs to be treated. The end of the inner balloon 12 is connected to the outer balloon 11 through a connecting joint and controls the fixed or rotating state of the inner balloon 12.

[0073] Reference Figure 2 The drug delivery hole includes a dialysis through hole 1111, which penetrates the outer balloon 11 and connects the gap between the outer balloon 11 and the inner balloon 12 and the external space of the outer balloon 11, and releases the drug in the gap between the outer balloon 11 and the inner balloon 12 onto the blood vessel wall through the dialysis through hole 1111.

[0074] Reference Figure 2 The outer balloon 11 is coated with a surface coating on the outside, and the surface coating assists the drug release and fixation to the surface of the blood vessel wall. The surface coating assists the drug release and fixation to the surface of the blood vessel wall and includes a releasing agent 1132 and an adhesive 1133.

[0075] The Schiff base hydrogel bioactive adhesive 1133 and the release agent 1132 are mixed and sprayed on the balloon surface by ultrasonic spraying. The release agent 1132 plays the role of a spacer adhesive, and the adhesive 1133 can firmly fix the spray layer on the balloon.

[0076] Reference Figure 2 The connecting joint includes a rotating joint 1212 , which connects the nested outer balloon 11 and the inner balloon 12 and assists the inner balloon 12 to rotate relative to the outer balloon 11 .

[0077] Reference Figure 2 The outer surface of the inner balloon 12 is provided with a cutting structure 123, and the cutting structure 123 includes a protruding airbag 1231 and an air hole 1232. One side of the protruding airbag 1231 is installed on the outer surface of the inner balloon 12 and connected to the inner cavity of the inner balloon 12 through the air hole 1232, and the other side of the protruding airbag 1231 is wedge-shaped and expands outward to squeeze the blood vessel wall.

[0078] Reference Figure 2The drugs released from the outer balloon 11 and the inner balloon 12 are mixed in the drug-carrying matrix, and the drug-carrying matrix drives the drug to be transported and released and adheres to the blood vessel wall. The drug-carrying matrix includes a hydrophilic matrix, a stabilizer and a solvent. The drug and the drug-carrying matrix are micronized and dissolved.

[0079] The balloon 1 is pressurized and infused with drugs. When pressurized, the drugs seep out through the dialyzer holes 1111 and are released on the blood vessel wall. The adhesive coating is ruptured by the pressurization and the protruding structure. The adhesive is quickly dispersed under the action of the release agent and combines with the drugs, so that the drugs are closely attached to the blood vessel wall, which can retain the drugs for a longer time. At the same time, the inner balloon 12 is inflated by the pressurization. Affected by the dialyzer holes, the protruding airbag 1231 will be inflated and stand up from a folded state. During the standing up process, affected by the power, the protruding airbag 1231 cuts the plaque. At the same time, because of the protection of the outer balloon 11, the protruding airbag 1231 will not damage the blood vessel wall. And because of the squeezing effect of the protruding airbag 1231 on the blood vessel wall, the drugs can be released deeply and evenly.

[0080] The protruding airbag 1231 is in a folded state. When it stands up, it will be affected by kinetic energy and cut the calcified plaque. The special design of the protruding airbag 1231 can basically cover the entire blood vessel wall. The present invention is different from other similar balloons. It not only relies on the sharp surface to cut, but more on the action of the protruding airbag 1231 in the folding and standing process to cut. The outer balloon 11 is very thin, which can produce an excellent cutting effect while reducing friction with the blood vessel wall, and the protruding design can better allow the drug to penetrate and release.

[0081] The protruding airbag 1231 of the present invention can achieve cutting of calcified plaques and also play a supporting role. Moreover, because there is no blood blockage, it can support for a longer time and continuously release drugs, thereby greatly improving the treatment effect.

[0082] Embodiment 3:

[0083] The present invention discloses a novel drug balloon device, referring to Figure 3 , including a balloon 1, a catheter 2 and a connecting seat 3, wherein the balloon 1 is installed at the front end of the catheter 2 and intervenes in the blood vessel for treatment, and the connecting seat 3 is installed at the rear end of the catheter 2 and manipulates the balloon 1 and the catheter 2 to intervene in the blood vessel to reach the treatment position outside the body, and the balloon 1 includes an outer balloon 11 and an inner balloon 12, wherein the outer balloon 11 is wrapped around the outside of the inner balloon 12 and a gap is formed between the outer balloon 11 and the inner balloon 12, and drugs are stored in the gap formed between the outer balloon 11 and the inner balloon 12, and the therapeutic drugs are released to the blood vessel wall by the support or expansion of the inner balloon 12.

[0084] Reference Figure 3The outer balloon 11 is provided with a drug delivery hole, and the drug flows out from the drug delivery hole and is released onto the blood vessel wall that needs to be treated. The end of the inner balloon 12 is connected to the outer balloon 11 through a connecting joint and controls the fixed or rotating state of the inner balloon 12.

[0085] Reference Figure 3 The drug delivery hole includes a dialysis through hole 1111, which penetrates the outer balloon 11 and connects the gap between the outer balloon 11 and the inner balloon 12 and the external space of the outer balloon 11, and releases the drug in the gap between the outer balloon 11 and the inner balloon 12 onto the blood vessel wall through the dialysis through hole 1111.

[0086] Reference Figure 3 The outer side of the outer balloon 11 is coated with a surface coating, and the surface coating protects the drug from being attached to the outer balloon 11 . The surface coating that protects the drug from being attached to the outer balloon 11 includes a hydrophobic coating 1131 .

[0087] Reference Figure 3 The connecting joint includes a rotating joint 1212 , which connects the nested outer balloon 11 and the inner balloon 12 and assists the inner balloon 12 to rotate relative to the outer balloon 11 .

[0088] Reference Figure 3 The outer surface of the inner balloon 12 is provided with a cutting structure 123, and the cutting structure 123 includes a protruding airbag 1231 and an air hole 1232. One side of the protruding airbag 1231 is installed on the outer surface of the inner balloon 12 and connected to the inner cavity of the inner balloon 12 through the air hole 1232, and the other side of the protruding airbag 1231 is wedge-shaped and expands outward to squeeze the blood vessel wall.

[0089] Reference Figure 3 The drugs released from the outer balloon 11 and the inner balloon 12 are mixed in the drug-carrying matrix, and the drug-carrying matrix drives the drug to be transported and released and adheres to the blood vessel wall. The drug-carrying matrix includes a hydrophilic matrix, a stabilizer and a solvent. The drug and the drug-carrying matrix are micronized and dissolved.

[0090] Embodiment 4:

[0091] The present invention discloses a novel drug balloon device, referring to Figure 4 , including a balloon 1, a catheter 2 and a connecting seat 3, wherein the balloon 1 is installed at the front end of the catheter 2 and intervenes in the blood vessel for treatment, and the connecting seat 3 is installed at the rear end of the catheter 2 and manipulates the balloon 1 and the catheter 2 to intervene in the blood vessel to reach the treatment position outside the body, and the balloon 1 includes an outer balloon 11 and an inner balloon 12, wherein the outer balloon 11 is wrapped around the outside of the inner balloon 12 and a gap is formed between the outer balloon 11 and the inner balloon 12, and drugs are stored in the gap formed between the outer balloon 11 and the inner balloon 12, and the therapeutic drugs are released to the blood vessel wall by the support or expansion of the inner balloon 12.

[0092] Reference Figure 4 The outer balloon 11 is provided with a drug delivery hole, and the drug flows out from the drug delivery hole and is released onto the blood vessel wall that needs to be treated. The end of the inner balloon 12 is connected to the outer balloon 11 through a connecting joint and controls the fixed or rotating state of the inner balloon 12.

[0093] Reference Figure 4 The drug delivery hole includes a hollow through hole 113, and the hollow through holes 113 are evenly arranged and independently opened on the outer balloon 11. The outer surface of the outer balloon 11 is provided with an outer micro blind hole 1112, and the outer surface of the inner balloon 12 is provided with an inner micro blind hole 122. The drugs stored in the outer micro blind holes 1112 are directly released onto the blood vessel wall, and the drugs stored in the inner micro blind holes 122 are released onto the blood vessel wall through the hollow through holes 113. A blood through hole 112 is physically opened at the gap between the hollow through holes 113 of the outer balloon 11, and the blood in the blood vessel flows through the blood through hole 112 at both ends of the blockage of the outer balloon 11.

[0094] Reference Figure 4 The outer balloon 11 is coated with a surface coating on the outside, and the surface coating protects the drug from attaching to the outer balloon 11 and / or assists the drug in releasing and fixing to the surface of the blood vessel wall. The surface coating that protects the drug from attaching to the outer balloon 11 includes a hydrophobic coating 1131, and the surface coating that assists the drug in releasing and fixing to the surface of the blood vessel wall includes a releasing agent 1132 and an adhesive 1133.

[0095] Reference Figure 4 The connecting section includes a fixed section 1211 or a rotating section 1212. The fixed section 1211 connects the outer balloon 11 and the inner balloon 12 and fixes them to each other. The rotating section 1212 connects the nested outer balloon 11 and the inner balloon 12 and assists the inner balloon 12 to rotate relative to the outer balloon 11.

[0096] The catheter 2 is a double-layer design, connected to the inner and outer layers respectively. Through this design, the rotation of the fixed position of the internal coating can be achieved.

[0097] Reference Figure 4 The drugs released from the outer balloon 11 and the inner balloon 12 are mixed in the drug-carrying matrix, and the drug-carrying matrix drives the drug to be transported and released and adheres to the blood vessel wall. The drug-carrying matrix includes a hydrophilic matrix, a stabilizer and a solvent. The drug and the drug-carrying matrix are micronized and dissolved.

[0098] After the balloon 1 is sprayed, it is dried and the inner balloon 12 is rotated when the slightly-inflated inner balloon 12 is not tightly attached, so that the sprayed part of the inner balloon 12 is hidden under the outer balloon 11. The outer balloon 11 and the inner balloon 12 below both contain medicine, and the inner balloon 12 is partially a bare balloon. There is a gap in the double-layer balloon in the slightly-inflated state, and the balloon will not be lost due to friction during rotation.

[0099] After the balloon 1 reaches the designated position, the balloon 1 is pressurized to a slightly pressurized state, the inner balloon 12 is rotated to expose the inner and outer drug-containing portions, and the balloon 1 continues to be pressurized.

[0100] The double-layer balloon 1 part is higher than the single-layer inner balloon 12 part because there is an outer balloon 11 outside the inner balloon 12. When the double-layer balloon 1 is close to the blood vessel wall, the inner balloon 12 will not. The unique hollow design of the outer balloon 11, the blood vessel wall and the adjacent outer balloon 11 form chambers, which reduces the inner balloon 12 being washed away by the drug blood, and has more time to contact and act on the blood vessel wall. At the same time, there are blood through holes 112 in the side walls of the hollow outer balloon 11, which can allow part of the blood flow to pass through without completely blocking the blood flow.

[0101] Embodiment 5:

[0102] The embodiment of the present invention discloses a novel method for using a drug balloon device, including the following method and steps:

[0103] The balloon 1 and the catheter 2 are punctured into the blood vessel under the control of the connecting seat 3 and reach the lesion position along the blood vessel;

[0104] The outer balloon 11 and the inner balloon 12 are inflated to prop up the narrowed blood vessel. The inner balloon 12 actively expands to prop up the outer balloon 11, and the outer balloon 11 limits the expansion size of the inner balloon 12.

[0105] The drugs carried by the outer balloon 11 and the inner balloon 12 are released onto the blood vessel wall, and the inner balloon 12 is further expanded and squeezed to accelerate the release of the drugs carried by the outer balloon 11 and the inner balloon 12 onto the blood vessel wall;

[0106] The outer balloon 11 and the inner balloon 12 are deflated and contracted, and then withdrawn along the blood vessel and finally removed from the blood vessel.

[0107] The above contents are merely examples and explanations of the structure of the present invention. The technicians in this technical field may make various modifications or additions to the specific embodiments described or replace them in a similar manner. As long as they do not deviate from the structure of the invention or exceed the scope defined by the claims, they should all fall within the protection scope of the present invention.

Claims

1. A novel drug balloon device, comprising a balloon (1), a catheter (2) and a connecting seat (3), wherein the balloon (1) is installed at the front end of the catheter (2) and is inserted into a blood vessel for treatment, and the connecting seat (3) is installed at the rear end of the catheter (2) and is used to control the balloon (1) and the catheter (2) to be inserted into a blood vessel to reach a treatment position outside the body, characterized in that: The balloon (1) comprises an outer balloon (11) and an inner balloon (12), wherein the outer balloon (11) is wrapped around the outer side of the inner balloon (12) and a gap is formed between the outer balloon (11) and the inner balloon (12), and drugs are stored in the gap formed between the outer balloon (11) and the inner balloon (12), and the therapeutic drugs are released toward the blood vessel wall by supporting or expanding the inner balloon (12).

2. A novel drug balloon device according to claim 1, characterized in that: The outer balloon (11) is provided with a drug delivery hole, and the drug flows out from the drug delivery hole and is released onto the blood vessel wall that needs to be treated. The end of the inner balloon (12) is connected to the outer balloon (11) through a connecting joint and controls the fixed or rotating state of the inner balloon (12).

3. A novel drug balloon device according to claim 2, characterized in that: The drug delivery hole includes a dialysis through hole (1111), which passes through the outer balloon (11) and connects the gap between the outer balloon (11) and the inner balloon (12) and the external space of the outer balloon (11), and releases the drug in the gap between the outer balloon (11) and the inner balloon (12) onto the blood vessel wall through the dialysis through hole (1111).

4. A novel drug balloon device according to claim 2, characterized in that: The drug delivery hole comprises a hollow through hole (113), the hollow through holes (113) are evenly arranged and independently opened on the outer balloon (11), the outer surface of the outer balloon (11) is opened with an outer micro blind hole (1112), the outer surface of the inner balloon (12) is opened with an inner micro blind hole (122), the drug stored in the outer micro blind hole (1112) is directly released onto the blood vessel wall, and the drug stored in the inner micro blind hole (122) is released onto the blood vessel wall through the hollow through hole (113), and a blood through hole (112) is physically opened at the gap between the hollow through holes (113) of the outer balloon (11), and the blood in the blood vessel flows through the blood through hole (112) at both ends of the outer balloon (11) that are blocked.

5. A novel drug balloon device according to claim 2, characterized in that: The outer balloon (11) is coated with a surface coating on the outside, and the surface coating protects the drug from being attached to the outer balloon (11) and / or assists the drug in being released and fixed to the surface of the blood vessel wall. The surface coating that protects the drug from being attached to the outer balloon (11) includes a hydrophobic coating (1131), and the surface coating that assists the drug in being released and fixed to the surface of the blood vessel wall includes a releasing agent (1132) and an adhesive (1133).

6. A novel drug balloon device according to claim 2, characterized in that: The connecting section includes a fixed section (1211) or a rotating section (1212), wherein the fixed section (1211) connects the outer balloon (11) and the inner balloon (12) and fixes them to each other, and the rotating section (1212) connects the nested outer balloon (11) and the inner balloon (12) and assists the inner balloon (12) to rotate relative to the outer balloon (11).

7. A novel drug balloon device according to claim 2, characterized in that: The outer surface of the inner balloon (12) is provided with a cutting structure (123), and the cutting structure (123) includes a protruding airbag (1231) and an air hole (1232). One side of the protruding airbag (1231) is installed on the outer surface of the inner balloon (12) and connected to the inner cavity of the inner balloon (12) through the air hole (1232), and the other side of the protruding airbag (1231) is wedge-shaped and expands outward to squeeze the blood vessel wall.

8. A novel drug balloon device according to claim 2, characterized in that: The drugs released from the outer balloon (11) and the inner balloon (12) are mixed in a drug-carrying matrix, which drives the drug to be transported and released and adheres to the blood vessel wall. The drug-carrying matrix includes a hydrophilic matrix, a stabilizer and a solvent. The drug and the drug-carrying matrix are micronized and dissolved.

9. A novel drug balloon device according to claim 2, characterized in that: The catheter (2) is connected to and installed with an injection tube (21) near the connecting seat (3), and the injection tube (21) injects drugs along the catheter (2) into the gap between the outer balloon (11) and the inner balloon (12). A control tube (22) is arranged in the catheter (2), and the control tube (22) connects the inner balloon (12) and the connecting seat (3) and connects the inner balloon (12) and the inflation device.

10. A method for using a novel drug balloon device, using the novel drug balloon device according to any one of claims 1 to 9, characterized in that: Including the following usage methods and steps: The balloon (1) and the catheter (2) are punctured into the blood vessel under the control of the connecting seat (3) and reach the lesion position along the blood vessel; The outer balloon (11) and the inner balloon (12) are inflated to prop up the narrowed blood vessel, the inner balloon (12) actively expands to prop up the outer balloon (11), and the outer balloon (11) limits the expansion size of the inner balloon (12); The drugs carried by the outer balloon (11) and the inner balloon (12) are released onto the blood vessel wall, and the inner balloon (12) is further expanded and squeezed to accelerate the release of the drugs carried by the outer balloon (11) and the inner balloon (12) onto the blood vessel wall; The outer balloon (11) and the inner balloon (12) are deflated and contracted, and then withdrawn along the blood vessel and finally removed from the blood vessel.

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