Drug-coated balloon catheters for non-vascular stenosis

Abstract

The invention discloses a drug-coated balloon catheter for non-vascular stenosis. The catheter comprises a catheter, wherein a balloon is fixed on the right side of the catheter, a catheter shaft is fixed on the right side of the balloon, a connector is fixed on the left side of the catheter, a handle is fixed on the top of the connector, a connecting tube is fixed on the left side of the connector, a connecting base is fixed on the left end of the connecting tube, an inner wall coating is arranged on the inner wall of the catheter, the balloon comprises a composition, the composition comprises a hydrophobic therapeutic agent and one or more water-soluble additives, the hydrophobic therapeutic agent comprises paclitaxel, paclitaxel analogs, docetaxel, docetaxel analogs, taxol, taxol analogs, sirolimus, sirolimus analogs, sirolimus, sirolimus analogs, everolimus, everolimus analogs, tacrolimus, and tacrolimus analogs. The invention can realize delayed release of drugs and rapid separation of body cavity tissue from fat, thereby improving the efficiency of surgery.

Description

Technical Field

[0001] The invention relates to the technical field of drug-coated balloon catheters for non-vascular stenosis, in particular to drug-coated balloon catheters for non-vascular stenosis. Background Art

[0002] Drug-coated balloon catheters for non-vascular stenosis are mainly used to treat benign prostatic hyperplasia, urethral stenosis, ureteral stenosis and other diseases. Its role and significance include improving drug absorption efficiency, reducing complications, and providing long-term efficacy. Through specific coating technology, drugs can be more effectively absorbed by the body cavity wall, improving treatment efficiency. The use of drug-coated balloon catheters can reduce complications caused by surgery, such as bleeding and infection. Compared with traditional treatment methods, drug-coated balloon catheters can provide more lasting treatment effects and reduce recurrence rates. Since the number of repeated treatments required is reduced, the patient's comfort is improved. Although the initial investment may be high, in the long run, the overall medical costs may be reduced due to the reduced need for repeated treatments.

[0003] When the existing device is used, its contact surface reacts with the patient's body, thereby increasing the inflammatory response. At the same time, without the use of additives, the body cavity tissue and oil are difficult to be absorbed, which in turn creates a certain risk for the operation. At the same time, without a coating, the release of the drug is difficult to prolong. Therefore, we propose a drug-coated balloon catheter for non-vascular stenosis. Summary of the invention

[0004] The object of the present invention is to provide a drug-coated balloon catheter for non-vascular stenosis to solve the problems raised in the above background technology.

[0005] To achieve the above-mentioned purpose, the present invention provides the following technical solution: a drug-coated balloon catheter for non-vascular stenosis, comprising a catheter, a balloon fixed to the right side of the catheter, a catheter shaft fixed to the right side of the balloon, a connector fixed to the left side of the catheter, a handle fixed to the top of the connector, a connecting tube fixed to the left side of the connecting member, a connecting base fixed to the left end of the connecting tube, and an inner wall of the catheter provided with an inner wall coating.

[0006] Further, the balloon comprises a composition comprising a hydrophobic therapeutic agent and one or more water-soluble additives.

[0007] Further, the hydrophobic therapeutic agent includes paclitaxel, paclitaxel analogs, docetaxel, docetaxel analogs, taxol, taxol analogs, sirolimus, sirolimus analogs, sirolimus, sirolimus analogs, everolimus, everolimus analogs, tacrolimus, tacrolimus analogs, mammalian sirolimus target protein inhibitors, mTOR inhibitor analogs, or other combinations.

[0008] Further, the water-soluble additive is selected from N-acetylglucosamine, N-octyl-D-glucosamine, N-nonanoyl-N-methylglucamine, N-octanoyl-N-methylglutamine, C6-ceramide, dihydro-C6-ceramide, cerebroside, sphingomyelin, galactocerebroside, lactocerebroside, N-acetyl-D-sphingosine, PEG diglyceryl caprylate / diglyceryl caprate, PEG8 monoglyceryl caprylate / monoglyceryl caprate, PEG8 caprylate, PEG caprylate, PEG caproate, glyceryl monocaprylate, glyceryl monocaprate, glyceryl monocaproate, glyceryl monolaurate, glyceryl monocaprate, glyceryl monocaproate, glyceryl monomyristate Glycerides, glyceryl monopalmitate, glyceryl monooleate, creatine, creatinine, agmatine, citrulline, guanidine, sucralose, aspartame, hypoxanthine, theobromine, theophylline, adenine, uracil, uridine, guanine, thymine, thymidine, xanthine, xanthine, xanthosine monophosphate, caffeine, allantoin, urea, N,N-diurea, pentaerythritol ethoxylate, pentaerythritol propoxylate, pentaerythritol propoxylate / ethoxylate, glycerol ethoxylate, glycerol propoxylate, trimethylolpropane ethoxylate, pentaerythritol, dipentaerythritol, crown ethers, 18-crown-6, 15-crown-5, 12-crown-4, and other combinations.

[0009] Furthermore, the main passage of the catheter is in the narrow area of ​​the gastrointestinal tract, the narrow area of ​​the stomach, the narrow area of ​​the colon, the narrow area of ​​the small intestine, the narrow area of ​​the esophagus, the narrow area of ​​the bile duct, etc.

[0010] Furthermore, the instruments connected to the connector include an endoscope, a guide wire and a handle.

[0011] Compared with the prior art, the beneficial effects of the present invention are as follows: by providing a catheter, a balloon, a catheter shaft, a handle, etc., when in use, the medicine is injected into the catheter, and then the catheter shaft is inserted into the patient's lesion, and the medicine inside the catheter is released by expanding the balloon. At the same time, the coating inside the catheter prevents the body cavity tissue from sticking to the oil. Through the above design, the delayed release of the medicine and the rapid separation of the body cavity tissue from the oil can be achieved, thereby improving the efficiency of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 It is a schematic diagram of the three-dimensional structure of the present invention;

[0013] Figure 2 It is a schematic diagram of the first partial structure of the present invention.

[0014] In the figure: 1. catheter; 2. balloon; 3. catheter shaft; 4. handle; 5. connecting base; 6. connecting piece; 7. inner wall coating. DETAILED DESCRIPTION

[0015] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. 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.

[0016] See also Figures 1-2, a drug-coated balloon catheter for non-vascular stenosis, comprising a catheter 1, a balloon 2 is fixed on the right side of the catheter 1, a catheter shaft 3 is fixed on the right side of the balloon 2, a connector 6 is fixed on the left side of the catheter 1, a handle 4 is fixed on the top of the connector 6, a connecting tube is fixed on the left side of the connector 6, a connecting base 5 is fixed on the left end of the connecting tube, an inner wall coating 7 is provided on the inner wall of the catheter 1, the balloon 2 contains a composition, the composition contains a hydrophobic therapeutic agent and one or more water-soluble additives, the hydrophobic therapeutic agent includes paclitaxel, paclitaxel analogs, docetaxel, docetaxel analogs, taxol, taxol analogs, paclitaxel The invention relates to sirolimus, sirolimus analogs, sirolimus, sirolimus analogs, everolimus, everolimus analogs, tacrolimus, tacrolimus analogs, mammalian sirolimus target protein (mTOR) inhibitors, mTOR inhibitor analogs, or other combinations thereof, wherein the water-soluble additive is selected from N-acetylglucosamine, N-octyl-D-glucosamine, N-nonanoyl-N-methylglucamine, N-octanoyl-N-methylglutamine, C6-ceramide, dihydro-C6-ceramide, cerebroside, sphingomyelin, galactocerebroside, lactocerebroside, N-acetyl-D-sphingosine, PEG Diglyceryl Caprylate / Diglyceryl Caprylate, PEG8 Monoglyceryl Caprylate / Monoglyceryl Caprate, PEG8 Caprylate, PEG Caproate, Glyceryl Monocaprylate, Glyceryl Monocaprate, Glyceryl Monocaproate, Glyceryl Monolaurate, Glyceryl Monocaprate, Glyceryl Monocaproate, Glyceryl Monomyristate, Glyceryl Monopalmitate, Glyceryl Monooleate, Creatine, Creatinine, Agmatine, Citrulline, Guanidine, Sucralose, Aspartame, Hypoxanthine, Theobromine, Theophylline, Adenine, Uracil, Uridine, Guanine, Thymine, Thymidine, Xanthine, Xanthine, Xanthine Monophosphate, Caffeine, Allantoin , (2-hydroxyethyl) urea, N,N-di(hydroxymethyl) urea, pentaerythritol ethoxylate, pentaerythritol propoxylate, pentaerythritol propoxylate / ethoxylate, glycerol ethoxylate, glycerol propoxylate, trimethylolpropane ethoxylate, pentaerythritol, dipentaerythritol, crown ether, 18-crown-6, 15-crown-5, 12-crown-4, and other combinations. The main passages of the catheter 1 are in the gastrointestinal tract narrowing area, the stomach narrowing area, the colon narrowing area, the small intestine narrowing area, the esophageal narrowing area, the bile duct narrowing area, etc. The instruments connected to the connector 6 include an endoscope, a guide wire and a handle;

[0017] Note that in one embodiment of the medical device, the device is capable of releasing a therapeutic agent and an additive, and delivering the therapeutic agent to the tissue within about 0.1 to 10 minutes, in one embodiment, the concentration of the therapeutic agent in the layer is 1 to 20 μg / mm2, in one embodiment, the concentration of the therapeutic agent in the layer is 2 to 10 μg / mm2, in one embodiment, the therapeutic agent is not water soluble (e.g., hydrophobic), and the additive enhances the release of the therapeutic agent out of the balloon, in another embodiment, the additive enhances the penetration and absorption of the therapeutic agent in the tissue, in another embodiment, the solubility of the additive in water and ethanol is at least 1 mg / ml, and the therapeutic agent is not The water-soluble layer covering the outer surface of the medical device includes a therapeutic agent and at least two additives, wherein each of the additives includes a hydrophilic portion and a drug-affinity portion, wherein the drug-affinity portion is at least one of the following: a hydrophobic portion, a portion that has affinity for the therapeutic agent through hydrogen bonding, and a portion that has affinity for the therapeutic agent through van der Waals interactions, and wherein each of the additives is soluble in a polar organic solvent and in water. In one aspect of the invention, the polar organic solvent is selected from methanol, ethanol, isopropanol, acetone, dimethylformamide, tetrahydrofuran, methyl ethyl ketone, dimethyl sulfoxide, acetonitrile, ethyl acetate, and chloroform, and mixtures of these polar organic solvents with water.

[0018] Working principle: When in use, a balloon 2 is fixed to the right side of the catheter 1, a catheter shaft 3 is fixed to the right side of the balloon 2, a connector 6 is fixed to the left side of the catheter 1, a handle 4 is fixed to the top of the connector 6, a connecting tube is fixed to the left side of the connector 6, a connecting base 5 is fixed to the left end of the connecting tube, an inner wall coating 7 is provided on the inner wall of the catheter 1, and the balloon 2 contains a composition, the composition contains a hydrophobic therapeutic agent and one or more water-soluble additives, and the hydrophobic therapeutic agent includes paclitaxel, paclitaxel analogs, docetaxel, docetaxel analogs, taxol, taxol analogs, sirolimus, and sirolimus analogs The invention relates to a pharmaceutical composition comprising a pharmaceutical composition comprising: ... Diglyceryl glycol ester, PEG8 caprylic acid monoglyceride / capric acid monoglyceride, PEG8 caprylate, PEG caprylate, PEG caproate, glyceryl monocaprylate, glyceryl monocaprate, glyceryl monocaproate, glyceryl monolaurate, glyceryl monocaprate, glyceryl monocaproate, glyceryl monomyristate, glyceryl monopalmitate, glyceryl monooleate, creatine, creatinine, agmatine, citrulline, guanidine, sucralose, aspartame, hypoxanthine, theobromine, theophylline, adenine, uracil, uridine, guanine, thymine, thymidine, xanthine, xanthine, xanthine monophosphate, caffeine, allantoin, (2- 1-hydroxyethyl) urea, N,N-di(hydroxymethyl) urea, pentaerythritol ethoxylate, pentaerythritol propoxylate, pentaerythritol propoxylate / ethoxylate, glycerol ethoxylate, glycerol propoxylate, trimethylolpropane ethoxylate, pentaerythritol, dipentaerythritol, crown ether, 18-crown-6, 15-crown-5, 12-crown-4, and other combinations. The main passages of the catheter 1 are in the gastrointestinal tract narrowing area, the stomach narrowing area, the colon narrowing area, the small intestine narrowing area, the esophageal narrowing area, the bile duct narrowing area, etc. The instruments connected to the connector 6 include an endoscope, a guide wire and a handle;

[0019] Note that in one embodiment of the medical device, the device is capable of releasing a therapeutic agent and an additive, and delivering the therapeutic agent to the tissue within about 0.1 to 10 minutes, in one embodiment, the concentration of the therapeutic agent in the layer is 1 to 20 μg / mm2, in one embodiment, the concentration of the therapeutic agent in the layer is 2 to 10 μg / mm2, in one embodiment, the therapeutic agent is not water soluble (e.g., hydrophobic), and the additive enhances the release of the therapeutic agent out of the balloon, in another embodiment, the additive enhances the penetration and absorption of the therapeutic agent in the tissue, in another embodiment, the solubility of the additive in water and ethanol is at least 1 mg / ml, and the therapeutic agent is not The water-soluble layer covering the outer surface of the medical device includes a therapeutic agent and at least two additives, wherein each of the additives includes a hydrophilic portion and a drug-affinity portion, wherein the drug-affinity portion is at least one of the following: a hydrophobic portion, a portion that has affinity for the therapeutic agent through hydrogen bonding, and a portion that has affinity for the therapeutic agent through van der Waals interactions, and wherein each of the additives is soluble in a polar organic solvent and in water. In one aspect of the invention, the polar organic solvent is selected from methanol, ethanol, isopropanol, acetone, dimethylformamide, tetrahydrofuran, methyl ethyl ketone, dimethyl sulfoxide, acetonitrile, ethyl acetate, and chloroform, and mixtures of these polar organic solvents with water.

[0020] The above description is only a preferred specific implementation manner of the present invention, but the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field can make equivalent replacements or changes according to the technical scheme and inventive concept of the present invention within the technical scope disclosed by the present invention, which should be covered by the protection scope of the present invention.

Claims

1. A drug-coated balloon catheter for non-vascular stenosis, comprising a catheter (1), characterized in that: A balloon (2) is fixed to the right side of the catheter (1), a catheter shaft (3) is fixed to the right side of the balloon (2), a connector (6) is fixed to the left side of the catheter (1), a handle (4) is fixed to the top of the connector (6), a connecting tube is fixed to the left side of the connector (6), a connecting base (5) is fixed to the left end of the connecting tube, and an inner wall coating (7) is provided on the inner wall of the catheter (1).

2. The drug-coated balloon catheter for non-vascular stenosis according to claim 1, characterized in that: The balloon (2) contains a composition comprising a hydrophobic therapeutic agent and one or more water-soluble additives.

3. The drug-coated balloon catheter for non-vascular stenosis according to claim 2, characterized in that: The hydrophobic therapeutic agent includes paclitaxel, paclitaxel analogs, docetaxel, docetaxel analogs, taxol, taxol analogs, sirolimus, sirolimus analogs, sirolimus, sirolimus analogs, everolimus, everolimus analogs, tacrolimus, tacrolimus analogs, mammalian target of sirolimus (mTOR) inhibitors, mTOR inhibitor analogs, or other combinations.

4. The drug-coated balloon catheter for non-vascular stenosis according to claim 2, characterized in that: The water-soluble additive is selected from N-acetylglucosamine, N-octyl-D-glucosamine, N-nonanoyl-N-methylglucamine, N-octanoyl-N-methylglutamine, C6-ceramide, dihydro-C6-ceramide, cerebroside, sphingomyelin, galactocerebroside, lactocerebroside, N-acetyl-D-sphingosine, PEG diglyceryl caprylate / diglyceryl caprate, PEG8 monoglyceryl caprylate / monoglyceryl caprate, PEG8 caprylate, PEG caprylate, PEG caproate, monocaprylic acid glyceryl, monocapric acid glyceryl, monocaprylic acid glyceryl, monolauric acid glyceryl, monocapric acid glyceryl, monocapric acid glyceryl, monomyristic acid glyceryl, monopalmitic acid glyceryl Esters, monoolein, creatine, creatinine, agmatine, citrulline, guanidine, sucralose, aspartame, hypoxanthine, theobromine, theophylline, adenine, uracil, uridine, guanine, thymine, thymidine, xanthine, xanthosine, xanthosine monophosphate, caffeine, allantoin, (2-hydroxyethyl) urea, N,N-bis(hydroxymethyl) urea, pentaerythritol ethoxylate, pentaerythritol propoxylate, pentaerythritol propoxylate / ethoxylate, glycerol ethoxylate, glycerol propoxylate, trimethylolpropane ethoxylate, pentaerythritol, dipentaerythritol, crown ethers, 18-crown-6, 15-crown-5, 12-crown-4, and other combinations.

5. The drug-coated balloon catheter for non-vascular stenosis according to claim 1, characterized in that: The main passages of the catheter (1) are in the gastrointestinal tract stenosis area, the stomach stenosis area, the colon stenosis area, the small intestine stenosis area, the esophageal stenosis area, and the bile duct stenosis area.

6. The drug-coated balloon catheter for non-vascular stenosis according to claim 1, characterized in that: The instruments connected to the connecting piece (6) include an endoscope, a guide wire and a handle.

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