DESC:TECHNICAL FIELD
[0001] The present invention relates, generally, to a flexible medical device on for perivascular implantation on lumen, tract or duct and particularly related to flexible medical devices having an active agent containing composition to deliver the active agent to treat resistant hypertension by altering the behavior of nerves situated in renal artery.

BACKGROUND
[0002] Resistant hypertension refers to a condition of high blood pressure which is not responding to medication. Renal denervation (RDN) is a minimally invasive procedure to treat resistant hypertension. This process causes a reduction in the nerve activity, which decreases blood pressure. Majority of these nerves are situated in the adventitia (outer) layer of the artery i.e. the renal nerves are closer to outer peripheral wall of the renal artery and up to some extent exposed on the outer wall as well. Hence, the main objective is to reach to the renal nerves and deliver the energy to deactivate these nerves, from outer side of the artery. This nerve deactivation causes reduction of sympathetic afferent and efferent activity to the kidney and blood pressure can be decreased.
[0003] Though renal denervation is a minimally invasive procedure but this procedure has some shortcomings too based on the mode of procedure employed. Commonly used procedures include electromagnetic radiation, ablation through thermal or electric energy etc. However, these cause irreversible and excessive injuries to the efferent (sympathetic) and afferent (sensory) fibers that constitute the renal nerves. This can alter renal function and central hemodynamics. Other possible complications include pseudoaneurysm (a bruise caused by a leaking hole in an artery) and tearing in the renal arteries. Instead of radiation or thermal or electrical energy the application of an active agent, including a chemical compound, pharmaceutical compound or a biological compound, is comparatively safer and can be continuously transferred to lumen, tract or duct for long durations.
[0004] Hence, it is an objective of the invention to provide a medical device having an active agent that achieves controlled release of the active agent at a target lesion by bringing the active agent or the active agent containing composition in perivascular contact with the target nerves present in the target lesion to treat diseases including Resistant Hypertension.
[0005] The above aspects are further illustrated in the figures and described in the corresponding description below. It should be noted that the description and figures merely illustrate principles of the present invention. Therefore, various arrangements that encompass the principles of the present invention, although not explicitly described or shown herein, may be devised from the description, and are included within its scope.

BRIEF DESCRIPTION OF ACCOMPANYING DRAWINGS
[0006] The detailed description is described with reference to the accompanying figures.
FIG. 1 illustrates a detailed view of a perivascularly wrapped active agent containing polymeric sheet, according to an embodiment of the present invention.
FIG. 2 illustrates an accelerated active agent release profile from a perivascular wrapped active agent containing polymeric sheet, according to an embodiment of the present invention.

DESCRIPTION OF THE INVENTION
[0007] An aspect of the present invention is to address at least the abovementioned problems and/or disadvantages and to provide at least the advantages described below.
[0008] As used herein, the term “an active agent” refers to a chemical compound, any biologically active compound or a pharmaceutical molecule that can be used in the formulation that is suitable for administration in mammals including humans.
[0009] As used herein, the term “lumen” refers to arteries or veins, the term “duct” refers to hollow vessels through which fluid passes from organs e.g. bile duct from liver, the term “tract” refers to hollow organs which may be connected as well e.g. gastrointestinal tract of mammals including humans.
[0010] As used herein, the term “micro-needles” refers to small geometrical indentations protruding from a surface of the medical device.
[0011] The present invention is directed towards a flexible medical device having an active agent that is implantable in a perivascular manner to achieve application of the active agent on to the outer surface of a lumen, duct or tract in the body of an animal including human.
[0012] According to an embodiment of the present disclosure, the flexible medical device comprising an active agent for perivascular application on an artery enables the transfer of the active agent to an area of the artery covered by the medical device.
[0013] In an embodiment, the flexible medical device comprises the active agent either in pure form or present in a composition.
[0014] In another embodiment, the medical device itself may be made of the active agent or the active agent containing composition.
[0015] In an aspect of the invention, the flexible medical device comprising the active agent or a composition comprising the active agent, on coming into contact with the artery in a perivascular manner, delivers the active agent which comes in contact with the tissues thus enabling transfer of the active agent from the medical device to the artery tissues through absorption and diffusion. The transferred active agent is selected or designed in such a manner so it affects the entire outer peripheral surface of the artery covered by the flexible medical device perivascularly or the active agent will only interact and affect the specific points or parts of the artery or within the wall of the artery e.g. nerve nodes. The active agent chemically or biologically reacts with specific nerves, molecules, cells or cell manufacturing matter to eliminate or change them to alter specific symptoms.
[0016] According to an embodiment of the present disclosure, the flexible medical device of the present invention is a flexible sheet made of an active agent or an active agent containing composition.
[0017] In another embodiment of the present disclosure, the active agent containing composition is a polymeric sheet comprising a polymeric matrix in which the active agent is dispersed throughout the polymeric matrix. In addition, the polymeric matrix may have more than one active agent as well. The other active agent is selected so that it may target the same symptoms or different symptoms or treat the after-effects generated due to sheet deployment or due to action of the active agent. Further, the polymeric sheet or the polymeric matrix may also have additional additives to enhance other required properties. These additives include, but not limited to, plasticizer, antioxidant, filler, lipophilic agent, hydrophilic agent, spacer agent, osmogenes, salts or combinations thereof.
[0018] Further, the polymeric matrix may comprise a polymer or a plurality of different polymeric materials. The polymeric sheet is wrapped around a lumen, specifically a renal artery, using a minimally invasive access instrument such as a laparoscope or an endoscope. However, the invention can be practiced using traditional surgery methods and through endovascular route or a combination of endovascular-perivascular route as well. By controlling different structural configurations and ratio of components in the polymeric matrix, the rate of release of the active agent can be controlled and a prolonged active agent delivery is achieved.
[0019] According to an embodiment of the present disclosure, the polymeric sheet is made of a composition comprising a biodegradable polymer, an active agent and a solvent. In the composition, the active agent to polymer ratio is between 5:95 to 70:30. The polymeric sheet is transportable to the target lesion site on the artery, specifically the renal artery, through a specifically designed access instrument. At the target lesion site, the polymeric sheet or the polymeric sheet with the polymeric matrix either can be put as a patch or can be wrapped around (in perivascular or periadventitial manner).
[0020] According to an embodiment of the present disclosure, the solvent for the composition to make the polymeric sheet is selected from water, polymeric solvent, non-polymeric solvent, saline, biodegradable polymeric liquid or a mixture thereof.
[0021] In an embodiment of the invention, biocompatible or biodegradable adhesive, dissolvable/non-dissolvable stitches, staples, or sutures can be used with the polymeric sheet to ensure attachment of the polymeric sheet with the artery’s outer peripheral wall after the procedure.
[0022] In an embodiment of the invention, after wrapping the polymeric sheet or wrapping the polymeric sheet with the polymeric matrix or placing the polymeric patch around the specific artery; the active agent dispersed in the polymeric sheet or the polymeric patch or the polymeric matrix comes in contact with the wall of the artery, and starts absorbing onto the wall of the artery by diffusion. The absorbed active agent comes in contact with the nerves, molecules, cells or cell manufacturing matter and reduces their activity.
[0023] According to an embodiment of the present disclosure, the polymeric sheet or the polymeric matrix or the patch comprises a plurality of layers.
[0024] According to another embodiment of the present disclosure, the polymeric sheet or the polymeric matrix or the patch may have transferable micro-needles made of free active agent or active agent containing polymeric composition and in form of indentations of same or different geometrical shapes and protruding from a surface of the polymeric sheet or the polymeric matrix or the patch.
[0025] According to another embodiment of the present disclosure, the active agent containing polymeric matrix is a hydrogel instead of polymeric sheet. The hydrogel can be released through a syringe around the artery. The active agent is dispersed in the hydrogel similar to the polymeric sheet. However, the hydrogel approach will not require any staple, suture or stiches. Further, the properties of the hydrogel can be controlled by varying the polymeric composition and polymer structure.
[0026] According to an embodiment of the present disclosure, a polymeric matrix comprises poly-L-lactide and the active agent is sirolimus. The drug to polymer ratio in this polymeric composition is between 5:95 to 70:30. The polymeric matrix is designed to release the active agent in two phases: there is an initial burst of the active agent in first phase followed by a sustained release of the active agent in second phase. Initial burst of the active agent ensures required drug transfer and retention while the second phase active agent release replenishes the consumed quantity of the active agent over a period of time. The amount of active agent in the initial burst varies from 10 weight percent to 80 weight percent, preferably 15 weight percent to 60 weight percent and more preferably, 20 weight percent to 50 weight percent of the total amount of the drug present in the polymeric matrix.
[0027] In an aspect of the present invention, the flexible medical device comprising the polymeric matrix or hydrogel or an active agent or an active agent containing polymeric sheet successfully achieves perivascular implantation on the outer periphery of a lumen, tract or duct. Once an implanting equipment reaches the target lesion, a distal part of the equipment transfers the polymer matrix or hydrogel or an active agent or an active agent containing polymeric sheet.
[0028] In an embodiment of the invention, the implanting equipment may be selected from a group comprising a catheter, balloon catheter, syringe, a specifically designed catheter, a laparoscope or an endoscope.
[0029] Active agent based renal denervation procedures provide better precision in terms of delivery location and the amount of active agent need to be delivered. Also, it allows parallel or follow-up administration of medication at the target lesion to treat after-effects of the procedure. In addition, in some embodiments, this administration can be prolonged for a specific time duration. Hence, active agent based renal denervation provides a better alternative to traditional denervation systems to achieve dose-dependent, predictable, safe and essentially painless renal denervation.
[0030] Explained below is an exemplary embodiment of the present disclosure. As illustrated in Fig. 1, an active agent wrapped in a perivascular manner, containing polymeric sheet (302) is used to treat renal denervation in perivascular manner. In this procedure, using a laparoscope or endoscope, the active agent containing polymeric sheet is wrapped around the affected artery (304) and kept in wrapped condition using glue, adhesive, staples, sutures or stitches. In similar manner, an active agent containing hydrogel, instead of polymeric sheet (302), is disposed around the artery (304) in perivascular manner using a minimally invasive surgical instrument such as a catheter, endoscope or a laparoscope.
[0031] Fig. 2 illustrates a drug release profile of a sirolimus containing poly-L-lactide based flexible sheet exposed to a release medium (simulated biological fluid). The release profile is studied in accelerated condition for a duration of 24 hours. The release medium for accelerated study is a mixture of phosphate buffer saline, non-ionic surfactant and an organic solvent. The pH of the solution is kept at 7.4 and the release study is studied at 37° C temperature to mimic temperature of a normal human body. The drug release profile clearly shows two phases of active agent release: first phase is an initial burst of the active agent followed by a second phase of sustained release.
[0032] The non-ionic surfactant is selected from, but not limited to, different grades from a surfactant family selected from Tween, Brij, and Triton. The organic solvent is selected from, but not limited to, methanol, ethanol, Allyl alcohol, Ethanolamine, Hexane, Heptane, Cyclohexane, 1-octanol, Pentane, Xylene Acetone, Acetonitrile, Tetrahydrofuran, Nitromethane, chloroform, Dichloromethane, Ethyl acetate, or combinations thereof.
[0033] According to an embodiment of the present disclosure, the polymer in the polymeric sheet or polymeric matrix or hydrogel is selected from, but not limited to, biodegradable polymers, non-biodegradable polymers, polymers of L-lactide, Glycolide or combinations thereof, poly(hydroxybutyrate), polyorthoesters, poly anhydrides, poly(glycolic acid), poly(glycolide), poly(L-lactic acid), poly(L-lactide), poly(D-lactic acid), poly(D-lactide), poly(caprolactone), poly(trimethylene carbonate), polyester amide, polyesters, polyolefins, polycarbonates, polyoxymethylenes, polyimides, polyethers, and copolymers and combinations thereof.
[0034] According to an embodiment of the present disclosure, one or more active agent is selected from, but not limited to, anti-restenosis drugs, Neurolytic agents, Quaternary ammonium salts, Sodium Channel Blockers, Anesthetics, Conductive Fluids, Amino Acids, Amines, Calcium Channel Blockers, Diuretics, Heated fluids e.g. Saline, Hypotonic Fluids, Vasovasorum Constrictors, Neurotransmitter Chemicals, Venom, Sclerosant Agents, Anti-Nerve Growth Agents, Aminosteroids, Neurotoxins, Alcohols, 6-Hydroxydopamine, Acebutolol, Acetic Acid, Acetic Anhydride, Acetyl Chloride, Acetylcholine, Adenosine, Aflatoxins, Ambrisentan, Amiloride, Amiodarone, Amlodipine, Ammonia, Anti-Acetylcholinesterase, Anti-Dopamine Beta-Hydroxylase, Anti-Dopamine Beta-Hydroxylase Immunotoxin (DHIT), Anti-Dopamine Beta-Hydroxylase Saporin (DBH-SAP), Argon, Arsenic, Atenolol, Azitoxin, Benazepril, Benzocaine, Bepridil, Betanidine, Betaxolol, Bisoprolol, Bleomycin, Bosentan, Botulinum toxin, Bretylium Tosylate, BuLi, Bungarotoxin, Bupivacaine, Bupranolol hydrochloride, Butanol, Ca(OH)2, Caffeine, Calciceptin, Calcycludin, Capsaicin, Carbamazepine, Carbon Dioxide, Cardiac Glycoside, Caribodotoxin, Carteolol, Carteolol hydrochloride, Catopril, Cetylcholine, Cevacine, Cevadine, Chloroquine, Chlorotoxin, Clonidine, Conotoxin, Curare, Cymarins, Cytochalasin D, Debrisoquine, Decarbamoyl Saxitoxins, Dibucaine, Digitalis, Digitoxins, Digoxins, Diltiazem, Dimethyl Sulfoxide, Diprophylline, Disopyramide, Dobutamine hydrochloride, Domoic Acids, Dopamine hydrochloride, Doxazosin, Doxycycline, Enalapril, Enalaprilat, Encainide, Epinephrin, Esmolol, Ethanol, Ethanolamine Oleate, Ethyl Acetate, Ethyl Chloroformate, Ethyl Iodide, Ethyl Lactate, Ethyl Nitrate, Ethylene glycol, Everolimus, pimecrolimus, tacrolimus, rapamycin, biolimus Felodipine, Fimolol, Flecainide, Fosinopril, Furosemide, Glutamate, Glycerin, Glycerol, Guanabenz, Guanacline, Guanadrel, Guanazodine, Guanethidine, Guanethidine Sulfates, Guanfacine, Guanidinium, Guanoclor, Guanoxabenz, Guanoxan, H2O2, Helium, Hexane, Hydriodic Acid, Hydrobromic Acid, Hydrochloric Acid, Hypertonic Saline, Indoramin, Isobutanol, Isopropanol, Isopropyl Acetate, Isopropyl Iodide, Isoquinoline, Isradipine, K2CO3, Ketanserin, KH, KOH, Labetalol, Lactic Acid, Laureth (Polidocanol), Leptocurare, Lidocaine, Lipiodol, Lisinopril, Losartan, Malonic Acid, Malonyl Chloride, Margatoxin, Maurotoxin, Mecamylamine, Methanol, Methyl Acetate, Methyldopa, Metildigoxin, Metirosine, Metoprolol, Metoprolol tartrate, Mexiletine, Minosteroids, Moexipril, Moricizine, Morrhuate Sodium, Moxonidine, Mycophenolic Acid, N-(2-Chloroethyl)-N-Ethyl-2-Bromobenzylamine (DSP4), Nadolol, NaH, NaHCO3, NaOEt, NaOH, NaSEt, Neosaxitoxins, NH4OH, Nicardipine, Nifedipine, Nimodipine, Nitric Acid, Nitric oxide, Nitrogen, Nitrous Acid, N-Methyl-(R)-Sarsolinol, Octopamine hydrochloride, Oleandrins, Ouabin, Oxalic Acid, Oxprenolol hydrochloride, Oxygen, Oxytetracycline, Pachycurare, Paclitaxel, Pargyline, Penbatolol, Peracetic Acid, Perchloric Acid, Phenol, Phentolamine, Pheoxybenzamine, Phosphoric Acid, Phtx3 (Phoneutria toxin), Pindolol, Polidocanol, Potassium Chloride, Povidone Iodine, Prazosin, Prazosin hydrochloride, Prazosin Plus Polythiazide, Procainamide, Propafenone, Propanol, Propranolol, Propranolol hydrochloride, Propyl Iodide, Proscillaridin, Pyruvic Acid, Quabains, Quinacrine, Quinapril, Quinidine, Quinine, Ramipril, Relmenidine, Rescinnamine, Reserpine, Resiniferatoxin, Saline, Saxitoxins, Sirolimus, MK-0431 (Sitagliptin phosphate), Sitaxentan, slatatoxin, Slototoxin, Sodium Chloride (Salt), Sodium Morrhuate, Sodium Tetradecyl Sulfate, Sotalol, Staurosporines, Sulfuric Acid, Talc, Taxol, Terazosin, Tetanus Toxin, Tetracaine, Tetracycline, Tetraethylammonium, Tetrodotoxin, Tocainide, Trichlormethiazide, Trimazosin, Trimethaphan, Tycatoxin, Ubidecarenon, Urapidil, Urea, Vanilloids, Vanilloylzygadenine, Heftoxin, Verapamils, Veratridine, Veratroylzygadenine with saline solution, Vinblastin, Vincristine, Zotarolimus, Zygacine, ß-carboline derivative, ?-conotoxin, Heparinized Saline, Butorakotoshkin, neuromodulators, botulinum oxide or combinations thereof.

[0035] The flexible medical device of the present invention is used for delivery of the active agent wherein the medical device comprises the active agent by way of a polymeric matrix, a flexible polymeric sheet or a hydrogel or a patch. Delivery of the active agent is achieved successfully by perivascular application of the polymeric matrix, the flexible polymeric sheet or the hydrogel or the patch around the outer periphery of an artery. The arteries may be femoral artery, renal artery, superficial femoral artery, popliteal artery, tibial artery, genicular artery, cerebral artery, carotid artery, vertebral artery, subclavian artery, radial artery, brachial artery, axillary artery, coronary artery, peripheral artery, iliac artery, or neuro-arteries. For example, the renal denervation catheter may be used in chemical renal denervation procedure.
[0036] In the above description, for the purpose of explanation, specific details are set forth in order to provide an understanding of the present disclosure. It will be apparent, however, to one skilled in the art that the present disclosure may be practiced without these details. One skilled in the art will recognize that embodiments of the present disclosure, one of which is described below, may be incorporated into a number of systems. Further, structures and devices shown in the figures are illustrative of exemplary embodiment of the present disclosure and are meant to avoid obscuring the present disclosure.
,CLAIMS:
1. A flexible medical device for the perivascular administration of an active agent to the lumen, tract or duct of a mammal, comprising:
a flexible medical device made of a composition which further comprises;
a polymer;
an active agent;
optionally a solvent; and
optionally, an additive,
wherein the amount of active agent and the polymer in the composition are in a ratio of 5:95 to 70:30.
2. The flexible medical device as claimed in claim 1, wherein the composition is in form of a polymeric sheet, polymeric matrix, hydrogel, patch, or combinations thereof.
3. The flexible medical device as claimed in claim 2, wherein the polymeric sheet, the polymeric matrix or the patch comprises a plurality of layers.
4. The flexible medical device as claimed in claim 1, wherein the polymer comprised in the composition is selected from a biodegradable polymer, a non-biodegradable polymer or combinations thereof.

5. The flexible medical device as claimed in claim 1, wherein the medical device is selected from a group including a catheter, balloon catheter, syringe, laproscope and endoscope.
6. The flexible medical device as claimed in claim 1, wherein the medical device is preferably a catheter.

7. The flexible medical device as claimed in claim 1 wherein the active agent in the composition comprised in the medical device is selected from anti-restenosis drugs, Neurolytic agents, Quaternary ammonium salts, Sodium Channel Blockers, Anesthetics, Conductive Fluids, Amino Acids, Amines, Calcium Channel Blockers, Diuretics, Saline, Hypotonic Fluids, Vasovasorum Constrictors, Neurotransmitter Chemicals, Venom, Sclerosant Agents, Anti-Nerve Growth Agents, Aminosteroids, Neurotoxins, Alcohols, 6-Hydroxydopamine, Acebutolol, Acetic Acid, Acetic Anhydride, Acetyl Chloride, Acetylcholine, Adenosine, Aflatoxins, Ambrisentan, Amiloride, Amiodarone, Amlodipine, Ammonia, Acetylcholinesterase, Anti-Dopamine, Beta-Hydroxylase, Anti-Dopamine Beta-Hydroxylase Immunotoxin, Beta-Hydroxylase Saporin, Argon, Arsenic, Atenolol, Azitoxin, Benazepril, Benzocaine, Bepridil, Betanidine, Betaxolol, Bisoprolol, Bleomycin, Bosentan, Botulinum toxin, Bretylium Tosylate, BuLi, Bungarotoxin, Bupivacaine, Bupranolol hydrochloride, Butanol, calcium hydroxide, Caffeine, Calciceptin, Calcycludin, Capsaicin, Carbamazepine, Carbon Dioxide, Cardiac Glycoside, Caribodotoxin, Carteolol, Carteolol hydrochloride, Catopril, Cetylcholine, Cevacine, Cevadine, Chloroquine, Chlorotoxin, Clonidine, Conotoxin, Curare, Cymarins, Cytochalasin D, Debrisoquine, Decarbamoyl Saxitoxins, Dibucaine, Digitalis, Digitoxins, Digoxins, Diltiazem, Dimethyl Sulfoxide, Diprophylline, Disopyramide, Dobutamine hydrochloride, Domoic Acids, Dopamine hydrochloride, Doxazosin, Doxycycline, Enalapril, Enalaprilat, Encainide, Epinephrin, Esmolol, Ethanol, Ethanolamine Oleate, Ethyl Acetate, Ethyl Chloroformate, Ethyl Iodide, Ethyl Lactate, Ethyl Nitrate, Ethylene glycol, Everolimus, pimecrolimus, tacrolimus, rapamycin, biolimus Felodipine, Fimolol, Flecainide, Fosinopril, Furosemide, Glutamate, Glycerin, Glycerol, Guanabenz, Guanacline, Guanadrel, Guanazodine, Guanethidine, Guanethidine Sulfates, Guanfacine, Guanidinium, Guanoclor, Guanoxabenz, Guanoxan, hydrogen peroxide, Helium, Hexane, Hydriodic Acid, Hydrobromic Acid, Hydrochloric Acid, Hypertonic Saline, Indoramin, Isobutanol, Isopropanol, Isopropyl Acetate, Isopropyl Iodide, Isoquinoline, Isradipine, potassium carbonate, Ketanserin, potassium hydride, potassium hydroxide, Labetalol, Lactic Acid, Laureth, Leptocurare, Lidocaine, Lipiodol, Lisinopril, Losartan, Malonic Acid, Malonyl Chloride, Margatoxin, Maurotoxin, Mecamylamine, Methanol, Methyl Acetate, Methyldopa, Metildigoxin, Metirosine, Metoprolol, Metoprolol tartrate, Mexiletine, Minosteroids, Moexipril, Moricizine, Morrhuate Sodium, Moxonidine, Mycophenolic Acid, N-(2-Chloroethyl)-N-Ethyl-2-Bromobenzylamine, Nadolol, sodium hydride, sodium bicarbonate, NaOEt, NaSEt, Neosaxitoxins, ammonium hydroxide, Nicardipine, Nifedipine, Nimodipine, Nitric Acid, Nitric oxide, Nitrogen, Nitrous Acid, N-Methyl-(R)-Sarsolinol, Octopamine hydrochloride, Oleandrins, Ouabin, Oxalic Acid, Oxprenolol hydrochloride, Oxygen, Oxytetracycline, Pachycurare, Paclitaxel, Pargyline, Penbatolol, Peracetic Acid, Perchloric Acid, Phenol, Phentolamine, Pheoxybenzamine, Phosphoric Acid, Phoneutria toxin, Pindolol, Polidocanol, Potassium Chloride, Povidone Iodine, Prazosin, Prazosin hydrochloride, Prazosin Plus Polythiazide, Procainamide, Propafenone, Propanol, Propranolol, Propranolol hydrochloride, Propyl Iodide, Proscillaridin, Pyruvic Acid, Quabains, Quinacrine, Quinapril, Quinidine, Quinine, Ramipril, Relmenidine, Rescinnamine, Reserpine, Resiniferatoxin, Saline, Saxitoxins, Sirolimus, Sitagliptin phosphate, Sitaxentan, slatatoxin, Slototoxin, Sodium Chloride, Sodium Morrhuate, Sodium Tetradecyl Sulfate, Sotalol, Staurosporines, Sulfuric Acid, Talc, Taxol, Terazosin, Tetanus Toxin, Tetracaine, Tetracycline, Tetraethylammonium, Tetrodotoxin, Tocainide, Trichlormethiazide, Trimazosin, Trimethaphan, Tycatoxin, Ubidecarenon, Urapidil, Urea, Vanilloids, Vanilloylzygadenine, Heftoxin, Verapamils, Veratridine, Veratroylzygadenine with saline solution, Vinblastin, Vincristine, Zotarolimus, Zygacine, ß-carboline derivative, ?-conotoxin, Heparinized Saline, Butorakotoshkin, neuromodulators, botulinum oxide.
8. A composition as claimed in claim 1 wherein the polymer is selected from poly-L-lactide, poly(hydroxybutyrate), polyorthoesters, poly anhydrides, poly(glycolic acid), poly(glycolide), poly(L-lactic acid), poly(D-lactic acid), poly(D-lactide), poly(caprolactone), poly(trimethylene carbonate), polyester amide, polyesters, polyolefins, polycarbonates, polyoxymethylenes, polyimides, polyethers, their copolymers or terpolymers or combinations thereof.
9. The flexible medical device as claimed in claim 1, wherein the solvent for the composition is selected from water, polymeric solvent, non-polymeric solvent, saline, biodegradable polymeric liquid or a mixture thereof.
10. The flexible medical device as claimed in claims 1-2, wherein the composition comprising the active agent, wraps around a lumen, duct or tract of a mammal including humans.
11. The flexible medical device as claimed in claim 1 and claim 10, wherein the composition comprising the active agent wraps around a lumen selected from femoral artery, renal artery, superficial femoral artery, popliteal artery, tibial artery, genicular artery, cerebral artery, carotid artery, vertebral artery, subclavian artery, radial artery, brachial artery, axillary artery, coronary artery, peripheral artery, iliac artery, neuro-artery, or combinations thereof.