A drug balloon dilation catheter for non-vascular interventions

Abstract

This invention discloses a drug-eluting balloon dilation catheter for non-vascular interventional procedures, comprising a cutting element, a balloon, a guidewire, and an outer tube. The outer surface of the balloon is coated with an anti-proliferative drug, and the interior of the balloon has a hollow cavity. The cutting element is connected to the distal end of the balloon and has cutting blades. The outer tube is connected to the proximal end of the balloon and communicates with the cavity of the balloon. The guidewire is disposed within the cavity of the balloon and extends axially along the balloon. This design ensures that the drug-eluting balloon can smoothly pass through narrowed lesions in body cavities while minimizing drug loss.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a drug-eluting balloon dilation catheter for non-vascular interventional procedures. Background Technology

[0002] Stenosis of non-vascular cavities in the human body is a common type of disease, which mainly includes urinary tract stenosis (urethral stenosis and ureteral stenosis), digestive tract stenosis (esophageal stenosis and intestinal stenosis) and biliary tract stenosis.

[0003] The main causes of urinary tract stricture are trauma, chlamydial injury, and inflammation. There are many causes of gastrointestinal stricture, such as inflammatory stricture, postoperative anastomotic stricture, tumor-related stricture, developmental abnormalities, motility disorders (achalasia), and acid / alkali burns. Bile duct stricture is caused by bile duct injury and recurrent cholangitis, or by congenital scarring and narrowing of the bile duct lumen.

[0004] Currently available products primarily focus on drug-eluting balloon therapy for endovascular stenosis, with few reports on drug-eluting balloon therapy for stenosis of natural body cavities. These natural body cavities mainly include the ureter, urethra, digestive tract, biliary tract, and respiratory tract. The commonly used endovascular treatment for these cavities involves bare balloon dilation and stent placement. However, studies show that the restenosis rate after bare balloon dilation is as high as 30%–50%. Furthermore, stent placement can damage the cavity wall and, due to the prolonged implantation time, may cause irritation and inflammation. Additionally, stent implantation can lead to adhesion to the cavity wall, making subsequent removal difficult.

[0005] Drug-eluting balloons are a novel treatment for non-vascular stenosis. They work by applying a drug that inhibits cell proliferation to a balloon, delivering the balloon to the lesion site, and then dilating it to allow the drug to be transferred to the inner wall of the cavity, thereby inhibiting cell proliferation and preventing restenosis.

[0006] Drug-eluting balloon angioplasty was first used in the field of interventional vascular surgery. Based on current clinical results of commercially available drug-eluting balloons for interventional procedures, it has been found to be a very effective treatment for preventing restenosis. Furthermore, its "intervention without implantation" concept has made it widely accepted by doctors and patients. However, the requirements for drug-eluting balloons differ significantly from those for non-vascular cavities.

[0007] First, blood vessels are constantly flowing through them, so they are normally full, allowing drug-eluting balloons to pass through them easily. Non-vascular cavities, however, are normally deflated, making it difficult for balloons to pass through them. Second, vascular stenosis is mainly due to atherosclerosis. Except for some calcified lesions, the hardened stenosis within blood vessels is relatively soft, making it easier for drug-eluting balloons to pass through these areas. Furthermore, if the balloon comes into contact with these hardened areas, there is minimal drug loss on its surface. However, non-vascular cavities are mainly composed of scar tissue, which is harder, making it more challenging for drug-eluting balloons to pass through these narrow areas. Specifically, the cutting edge of the drug-eluting balloon may not be able to pass through the narrowed area. Even if the cutting edge can pass through, the balloon will scrape against the scar tissue during passage, resulting in significant drug loss.

[0008] Currently, there is still no drug-eluting balloon that is very suitable for non-vascular cavities, which can ensure that the drug-eluting balloon can pass smoothly through the stenotic lesion site while minimizing drug loss.

[0009] Therefore, it is necessary to develop a drug-eluting balloon dilation catheter suitable for non-vascular cavities, which can ensure that the drug-eluting balloon can pass smoothly through the stenotic lesion site while minimizing drug loss. Summary of the Invention

[0010] The purpose of this invention is to provide a drug-eluting balloon dilation catheter for non-vascular intervention, which can ensure that the drug balloon passes smoothly through the narrowed lesion site of the human body cavity while minimizing drug loss.

[0011] To achieve the above objectives, the present invention provides a drug-eluting balloon dilation catheter for non-vascular intervention, comprising a cutting element, a balloon, a guidewire, and an outer tube. The outer surface of the balloon is coated with an anti-proliferative drug, and the interior of the balloon has a hollow cavity. The cutting element is connected to the distal end of the balloon and has a cutting blade. The outer tube is connected to the proximal end of the balloon and communicates with the cavity of the balloon. The guidewire is disposed within the cavity of the balloon and extends axially along the balloon.

[0012] Preferably, the cutting element includes a mandrel and at least one cutting wing, the proximal end of the mandrel being connected to the distal end of the guide wire, the top of the cutting wing having a cutting blade extending axially along the mandrel, and the bottom of the cutting wing extending axially along the mandrel and connected to the outside of the mandrel.

[0013] Preferably, the number of cutting wings is 2 to 6, and they are evenly distributed along the circumference of the mandrel; the outer diameter of the cutting element is 0.8 to 1.2 times the outer diameter of the balloon when it is retracted.

[0014] Preferably, the distal ends of the plurality of cutting wings form a tapered structure in the direction away from the outer tube, with a taper of 5° to 20°.

[0015] Preferably, the thickness of the cutting blade is 0.01mm to 0.2mm.

[0016] Preferably, each of the cutting wings is slotted from the top to the bottom to form at least one groove.

[0017] Preferably, the number of grooves is 1-5.

[0018] Preferably, multiple imaging rings are provided outside the guide wire.

[0019] Preferably, the antiproliferative drug contains a first carrier and a second carrier, wherein the antiproliferative drug is paclitaxel, a paclitaxel derivative, rapamycin, or a rapamycin derivative, the first carrier is an ionic contrast agent or a monosaccharide, and the second carrier is a lipid-soluble compound having two or three hydrophilic groups.

[0020] Preferably, the anti-proliferative drug is paclitaxel, docetaxel, cabazitaxel, sirolimus, eucommilimus, everolimus, or zotalimus; the first carrier is meglumine diatrizoate, iodixanol, eucommiphene, sorbitol, glucose, or mannose; the second carrier is ferulic acid, salicylic acid, salicylol, citric acid, caffeic acid, vanillic acid, ethylene glycol salicylate, resveratrol, dihydroxyacetone, or astaxanthin.

[0021] Compared with existing technologies, this invention offers the following advantages: The drug-eluting balloon dilation catheter provided by this invention, through the placement of a cutting element at the distal end of the balloon, cuts the scar tissue as it passes through the lesion site, severing the fibrous tissue within the scar tissue. This ensures that the balloon can dilate the narrowed area with relatively low pressure during subsequent dilation. Furthermore, the cutting element supports the narrowed area to an appropriate size during its passage, facilitating the passage of the drug-eluting balloon through the narrowed area and reducing drug loss from the balloon surface. Additionally, this invention directly integrates the guidewire as part of the balloon structure, eliminating the need for a guidewire lumen. Therefore, during surgery, there is no need to insert a guidewire; the balloon catheter can be directly inserted into the lesion site for dilation. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of the distal end of the balloon dilation catheter in an embodiment of the present invention;

[0023] Figure 2 This is a schematic cross-sectional view of the distal end of the balloon dilation catheter in an embodiment of the present invention;

[0024] Figure 3aThis is a side view of the cutting component in an embodiment of the present invention; Figure 3b This is a front view of the cutting component in an embodiment of the present invention.

[0025] In the picture:

[0026] 21-Cutting component, 22-Balloon, 23-Guide wire, 24-Illuminating ring, 25-Outer tube, 31-Mandrel, 32-Cutting wing, 221-Cavity, 321-Distal end, 322-Tip, 323-Groove. Detailed Implementation

[0027] The present invention will now be further described with reference to the accompanying drawings and embodiments.

[0028] To more clearly describe the structural features of the present invention, the terms "proximal" and "distal" are used as directional terms, where "proximal" refers to the end closer to the operator during the procedure, and "distal" refers to the end farther from the operator. "Axial" refers to the direction of the central axis of the balloon or mandrel; "circumferential" refers to the direction along the circumference of the mandrel. The term "or" is generally used in a meaning that includes "and / or" unless otherwise expressly stated in the text.

[0029] Figure 1 This is a schematic diagram of the distal end of the balloon dilation catheter in an embodiment of the present invention; Figure 2 This is a schematic cross-sectional view of the distal end of the balloon dilation catheter in an embodiment of the present invention.

[0030] refer to Figure 1 and Figure 2 This embodiment provides a drug-eluting balloon dilation catheter for non-vascular interventional procedures, comprising a cutting element 21, a balloon 22, a guidewire 23, and an outer tube 25. The outer surface of the balloon 22 is coated with medication, and the interior of the balloon 22 has a hollow cavity 221. The cutting element 21 is connected to the distal end of the balloon 22 and has a cutting blade. The outer tube 25 is connected to the proximal end of the balloon 22 and communicates with the cavity 221 of the balloon 22. Normal saline can be infused into the cavity 221 of the balloon 22 through the outer tube 25 to dilate the balloon 22. The guidewire 23 is disposed within the cavity 221 of the balloon 22 and extends axially along the balloon 22. This invention directly integrates the guidewire 23 as part of the balloon 22 structure, eliminating the need for a guidewire lumen. Therefore, during surgery, there is no need to insert a guidewire; the balloon catheter can be directly inserted into the lesion site for dilation.

[0031] Figure 3a This is a side view of the cutting component in an embodiment of the present invention; Figure 3b This is a front view of the cutting component in an embodiment of the present invention.

[0032] refer to Figure 3a and Figure 3bIn one specific embodiment, the cutting element 21 includes a mandrel 31 and at least one cutting wing 32. The proximal end of the mandrel 31 is connected to the distal end of the guide wire 23. Preferably, the mandrel 31 is formed by extending the guide wire 23 distally. The top of the cutting wing 32 has a cutting blade extending axially along the mandrel 31, and the bottom of the cutting wing 32 extends axially along the mandrel 31 and is connected to the outside of the mandrel 31. The number of cutting wings 32 is preferably 2 to 6, evenly distributed circumferentially along the mandrel 31. Further, the distal ends 321 of the plurality of cutting wings 32 form a tapered structure in the direction away from the outer tube, with a taper of 5° to 20°. When the cutting element 21 contacts the narrow lesion site, it can easily open the scar tissue of the lesion site, facilitating the entry of the balloon 22. The cutting blade at the tip of the cutting wing 32 is preferably 0.01mm to 0.2mm thick. During the passage of the cutting element 21 through the narrow lesion, it cuts the fibrous tissue in the scar tissue, ensuring that the balloon 22 can expand the narrowed area with relatively low pressure during subsequent expansion. Each cutting wing 32 has at least one groove 323 formed from the top to the bottom. The groove 323 is preferably a U-shaped groove, and the number of grooves 323 is preferably 1-5. The grooves 323 ensure that the cutting element 21 has a certain degree of flexibility and toughness, preventing damage to the inner wall of the cavity due to excessive rigidity. Multiple imaging rings 24 are provided outside the guide wire 23 for convenient positioning and identification. Preferably, the outer diameter of the entire cutting element 21 is equal to, slightly larger than, or slightly smaller than the outer diameter of the balloon 22 after it is closed. This supports the narrowed area to a suitable size during the passage of the cutting element 21, facilitating the passage of the drug-coated balloon 22 through the narrowed area and reducing the loss of drug on the surface of the balloon 22. Preferably, the outer diameter of the cutting piece 21 is 0.8-1.2 times the outer diameter of the balloon 22 after it is folded up. For balloons 22 with a larger outer diameter, the outer diameter of the cutting piece 21 can be made slightly smaller than the outer diameter of the balloon 22 after it is folded up. For balloons 22 with a smaller outer diameter, the outer diameter of the cutting piece 21 can be made slightly larger than the outer diameter of the balloon 22 after it is folded up.

[0033] A first carrier and a second carrier are added to the anti-proliferative drug coated on the outer surface of the balloon 22. The anti-proliferative drug is selected from paclitaxel or paclitaxel derivatives, such as paclitaxel, docetaxel, etc., or rapamycin or rapamycin derivatives, such as sirolimus, eucommilimus, everolimus, etc., to inhibit cell proliferation and achieve the effect of preventing restenosis. The first carrier is an ionic contrast agent or a monosaccharide. Ionic contrast agents mainly include diatrizoate meglumine, iodixanol, or urofluidone, preferably urofluidone, which is a compound diatrizoate meglumine, the main components of which are diatrizoate meglumine and sodium diatrizoate. Monosaccharides mainly include sorbitol, glucose, or mannose, preferably mannose. The main reason for using ionic contrast agents is that, compared with non-ionic contrast agents, although ionic contrast agents are also hydrophilic, their viscosity does not decrease rapidly after dissolving in water, but still maintains a certain viscosity. Therefore, during water flow, the first carrier can still fix the drug on the balloon surface. The main reason for using monosaccharides is that monosaccharide molecules contain many hydrophilic groups, are easily soluble in water, and also produce a certain degree of viscosity, which can help attach the drug to the surface of the capsule. However, since hydrophilic carriers may cause uneven particle size of paclitaxel, this invention introduces a second carrier to solve this problem.

[0034] The second carrier is a lipophilic compound with two or three hydrophilic groups, such as ferulic acid, salicylic acid, salicylol, citric acid, caffeic acid, vanillic acid, ethylene glycol salicylate, resveratrol, dihydroxyacetone, astaxanthin, etc. Because the second carrier is lipophilic, it can form liposomes or polymer aggregates with the drug. Simultaneously, the lipophilic carrier can also produce fine and uniform drug particles, ultimately ensuring the drug release rate at the lesion site. Furthermore, since the first carrier is water-soluble and has a certain viscosity in water, some water can be locked on the balloon surface. The hydrophilic groups of the second carrier will then interact with this water, fixing the drug to the balloon surface during delivery and minimizing drug loss. When the balloon begins to dilate at the lesion site, and the drug comes into contact with the inner wall of the body's natural cavity, the second carrier has fewer hydroxyl groups and its affinity for water is less than its affinity for liposomes when it comes into contact with the inner wall of the cavity. Therefore, the second carrier will carry the drug and quickly detach from the first carrier and enter the inner wall of the cavity, thereby transferring a large amount of drug to the lesion site.

[0035] The drug-eluting balloon provided by this invention is used for balloon dilation treatment of non-vascular (natural human cavities) stenosis. Natural human cavities mainly include the ureter, urethra, digestive tract, biliary tract, and respiratory tract.

[0036] Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications and improvements without departing from the spirit and scope of the present invention. Therefore, the scope of protection of the present invention shall be defined by the claims.

Claims

1. A drug-eluting balloon dilation catheter for non-vascular interventional procedures, characterized in that, The device includes a cutting element, a balloon, a guide wire, and an outer tube. The outer surface of the balloon is coated with an anti-proliferative drug, and the interior of the balloon has a hollow cavity. The cutting element is connected to the distal end of the balloon. The outer tube is connected to the proximal end of the balloon and communicates with the cavity of the balloon. The guide wire is disposed within the cavity of the balloon and extends axially along the balloon. The cutting element includes a mandrel and at least one cutting wing. The proximal end of the mandrel is connected to the distal end of the guide wire. The top of the cutting wing has a cutting blade extending axially along the mandrel, and the bottom of the cutting wing extends axially along the mandrel and is connected to the outside of the mandrel.

2. The drug-eluting balloon dilation catheter according to claim 1, characterized in that, The number of cutting wings is 2 to 6, and they are evenly distributed along the circumference of the mandrel; the outer diameter of the cutting element is 0.8 to 1.2 times the outer diameter of the balloon when it is retracted.

3. The drug-eluting balloon dilation catheter according to claim 2, characterized in that, The distal ends of the plurality of cutting wings form a tapered structure along the direction away from the outer tube, with a taper of 5° to 20°.

4. The drug-eluting balloon dilation catheter according to claim 1, characterized in that, The thickness of the cutting disc is 0.01mm to 0.2mm.

5. The drug-eluting balloon dilation catheter according to claim 1, characterized in that, Each of the cutting blades is slotted from the top to the bottom to form at least one groove.

6. The drug-eluting balloon dilation catheter according to claim 5, characterized in that, The number of grooves is 1-5.

7. The drug-eluting balloon dilation catheter according to claim 1, characterized in that, Multiple imaging rings are provided outside the guide wire.

8. The drug-eluting balloon dilation catheter according to claim 1, characterized in that, The antiproliferative drug contains a first carrier and a second carrier. The antiproliferative drug is paclitaxel, a paclitaxel derivative, rapamycin, or a rapamycin derivative. The first carrier is an ionic contrast agent or a monosaccharide, and the second carrier is a lipid-soluble compound with two or three hydrophilic groups.

9. The drug-eluting balloon dilation catheter according to claim 8, characterized in that, The anti-proliferative drug is paclitaxel, docetaxel, cabazitaxel, sirolimus, eucommilimus, everolimus, or zotalimus; the first carrier is meglumine diatrizoate, iodixanol, eucommiphene, sorbitol, glucose, or mannose; the second carrier is ferulic acid, salicylic acid, salicylol, citric acid, caffeic acid, vanillic acid, ethylene glycol salicylate, resveratrol, dihydroxyacetone, or astaxanthin.

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