Method and a balloon catheter assembly for treating bifurcation lesions

• US 8,585,642 B2
• Filed: 01/17/2011
• Issued: 11/19/2013
• Est. Priority Date: 01/22/2010
• Status: Active Grant

• Current Assignee: Concept Medical Research Private Limited
• Original Assignee: Concept Medical Research Private Limited
• Inventors: Doshi, Manish, Sherdiwala, Divyesh, Sojitra, Prakash
• Primary Examiner(s): FLICK, JASON E
• Application Number:
  US13/124,119
• Publication Number:
  US 20120283635A1
• Time in Patent Office: 1,037 Days
• Field of Search: 604/101.04
• US Class Current: 604/101.04
• CPC Class Codes: A61K 9/127 Liposomes
• CPC Class Codes: A61L 2300/624 Nanocapsules
• CPC Class Codes: A61L 2400/12 Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61M 2025/1045 for treating bifurcations, e.g. balloons in y-configuration, separate balloons or special features of the catheter for treating bifurcations
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

The invention discloses a balloon catheter assembly for delivering nano-carriers to bifurcation lesions in one or more of a main branch and a side branch of a blood vessel bifurcation within 30 to 90 seconds. The balloon catheter assembly includes two or more balloons designed for use in the blood vessel bifurcation. A surface of one or more of the two or more balloons is coated with the nano-carriers. The nano-carriers include one or more drugs encapsulated with one or more biological agents.

Claims

1. A drug delivery system for delivering at least one drug to at least one of a first branch and a second branch of a blood vessel bifurcation, the drug delivery system comprising:

a first balloon catheter assembly having a first balloon capable of passing through the blood vessel and being at least partially positioned in the first branch;

a second balloon catheter assembly having a second balloon capable of passing through the blood vessel and being at least partially positioned in the second branch, wherein at least one of the first balloon and the second balloon is coated with a plurality of nano-carriers, the plurality of nano-carriers comprising at least one drug encapsulated with at least one biological agent, the at least one of the first balloon and the second balloon capable of delivering the plurality of nano-carriers to at least one of the first branch and the second branch upon being positioned and inflated in the at least one of the first branch and the second branch respectively;

wherein at least one of the first balloon and the second balloon comprises a hydrophilic surface and a non-hydrophilic surface, the hydrophilic surface being coated with the plurality of nano-carriers, wherein a set of nano-carriers of the plurality of nano-carriers is released from the hydrophilic surface within a predetermined duration in response to inflating the at least one of the first balloon and the second balloon at a target site in the at least one of the first branch and the second branch respectively;

wherein the hydrophilic surface has a layer coated thereon, the layer comprising nano-particles of one of the at least one biological agent and at least one polymer; and

wherein the layer further comprises a plurality of pores, wherein at least one nano-carrier of the plurality of nano-carriers is deposited in at least one pore of the plurality of pores, wherein the hydrophilic surface is exposed through the plurality of pores and the at least one nano-carrier is in direct contact with the hydrophilic surface.

2. The drug delivery system of claim 1, wherein a proximal diameter of the second balloon is smaller than a distal diameter of the second balloon in an inflated state and a proximal diameter of the first balloon is smaller than or equal to a distal diameter of the first balloon in an inflated state.

3. The drug delivery system of claim 1, wherein the first balloon has at least one of a shape, a size and dimensions different from the second balloon.

4. The drug delivery system of claim 1, wherein the predetermined duration ranges from 30 to 90 seconds.

5. The drug delivery system of claim 1, wherein the at least one biological agent exhibits an effect, the effect is at least one of stabilizing the at least one drug, and affinity for tissues of the blood vessel bifurcation.

6. The drug delivery system of claim 1, wherein the plurality of nano-carriers have an average diameter ranging between 1 nm to 1000 nm.

7. The drug delivery system of claim 1, wherein the plurality of nano-carriers further comprise a first set of nano-carriers having a first average diameter and a second set of nano-carriers having a second average diameter, the first average diameter being different from the second average diameter.

8. The drug delivery system of claim 7, wherein the first average diameter ranges from 1 nm to 700 nm and the second average diameter ranges from 300 nm to 1000 nm.

9. The drug delivery system of claim 1, wherein the plurality of nano-carriers further comprise a first set of nano-carriers with a first average diameter, a second set of nano-carriers with a second average diameter, and a third set of nano-carriers with a third average diameter.

10. The drug delivery system of claim 9, wherein the first average diameter ranges from 1 nm to 500 nm, the second average diameter ranges from 300 nm to 800 nm, and the third average diameter ranges from 500 nm to 1000 nm.

11. The drug delivery system of claim 1, wherein the at least one biological agent is selected from a group comprising drug carriers, excipients, blood components, excipients derived from blood, phospholipids, solid lipid nano-particles, lipoids, vitamins and sugar molecules.

12. The drug delivery system of claim 1, wherein the at least one biological agent is selected from at least one of a steroid, a vitamin, an estradiol, an esterified fatty acid, a non-esterified fatty acid, glucose, inositol, L-lactate, a lipoprotein, a carbohydrate, tricalcium phosphate, precipitated calcium phosphate, a substance derived from at least one of human, egg and soybean, phospholipon 80H, phospholipon 90H, a preparation containing fat free soybean phospholipids with 70% phosphatidylcholine, a preparation containing egg phospholipids with 80% phosphatidylcholine, a preparation containing 20% soybean oil, 1.2% egg yolk phospholipids, 2.25% glycerin, and water, hydrogenated phosphatidylcholine from egg, a preparation containing 72.6% phosphatidylcholine, 13.5% phosphatidylethanolamine, 2.6% lysophosphatidylcholine, and 2.3% sphingomyelin, a lipid obtained from egg, a lipid obtained from soya, phosphatidylcholine, phosphatidylglycerol, phosphatidylinositol, phosphatidylserine, phosphatidic acid, cardiolipin, and phosphatidylethanolamine.

13. The drug delivery system of claim 1, wherein at least one nano-carrier of the plurality of nano-carriers further comprises at least one nano-particle of the at least one drug encapsulated with nano-particles of the at least one biological agent and nano-particles of at least one polymer, the at least one polymer comprising at least one of a biodegradable polymer, a non-degradable polymer, a bioderodable polymer, an excipient, a drug, and a polymer matrix.

14. The drug delivery system of claim 13, wherein the at least one polymer is selected from at least one of poly(1-lactide), racemic polylactide, poly(1-lactide-co-glycolide), racemic poly(1-lactide-co-glycolide), poly(1-lactide-co-caprolactone poly(d,1-lactide-co-caprolactone), poly(1-lactide-co-trimethylene carbonate) and poly(d,1-lactide-co-trimethylene carbonate), and wherein the at least one polymer is covalently attached to at least one of the at least one drug and the at least one biological agent.

15. The drug delivery system of claim 1, wherein the at least one drug is selected from at least one of an anti-proliferative agent, an anti-inflammatory agent, an anti-neoplastic agent, an anti-coagulant agent, an anti-fibrin agent, an antithrombotic agent, an anti-mitotic agent, an antibiotic agent, an anti-allergic agent, an antioxidant, at least one flavonoid, an estrogen, a protease inhibitor, an antibody, an immunosuppressive agent, a cytostatic agent, a cytotoxic agent, a calcium channel blocker, a phosphodiesterase inhibitor, a prostaglandin inhibitor, a dietary supplement, a vitamin, an anti-platelet aggregating agent, and genetically engineered epithelial cells, wherein the at least one flavonoids is selected from at least one of narigenin, naringin, eriodictyol, hesperetin, hesperidin (esperidine), kampferol, quercetin, rutin, cyanidol, meciadonol, catechin, epi-gallocatechin-gallate, taxifolin (dihydroquercetin), genistein, genistin, daidzein, biochanin, glycitein, chrysin, diosmin, luetolin, apigenin, tangeritin and nobiletin.

16. The drug delivery system of claim 1, wherein the at least one drug is selected from a group comprising sirolimus, paclitaxel, tacrolimus, clobetasol, dexamethasone, genistein, heparin, beta-estadiol, rapamycin, everolimus, ethylrapamycin, zotarolimus, ABT-578, umirolimus, docetaxel, methotrexate, azathioprine, vincristine, vinblastine, fluorouracil, doxorubicin hydrochloride, mitomycin, sodium heparin, low molecular weight heparin, heparinoid, hirudin, argatroban, forskolin, vapiprost, prostacyclin, prostacyclin analogues, dextran, D-phe-pro-arg-chloromethylketone, dipyridamole, glycoprotein IIb/IIIa, recombinant hirudin, bivalirudin, nifedipine, colchicines, lovastatin, nitroprusside, suramin, serotonin blockers, a steroid, thioprotease inhibitors, triazolopyrimidine, nitric oxide, nitric oxide donors, super oxide dismutase, super oxide dismutase mimetics, estradiol, aspirin, angiopeptin, captopril, cilazapril, lisinopril, permirolast potassium, alpha-interferon, and bioactive RGD.

17. The drug delivery system of claim 1, wherein the at least one drug is sirolimus.

18. The drug delivery system of claim 1, wherein the at least one drug is paclitaxel.

19. The drug delivery system of claim 1, wherein the drug delivery system is used to treat a medical condition associated with the blood vessel bifurcation, wherein the medical condition is at least one of stenosis, restenosis, blockage in an artery, thrombus in an artery, acute myocardial infarction, and arterial lesions.

20. The drug delivery system of claim 1, wherein the hydrophilic surface and the non-hydrophilic surface are coated with the plurality of nano-carriers.

21. The drug delivery system of claim 20, wherein at least one of the plurality of nano-carriers, the nano-particles of the at least one drug, the nano-particles of the at least one biological agent, and at least one excipient are deposited in a polymer matrix coated on at least one of the hydrophilic surface and the non-hydrophilic surface.