WO2020121318A1

WO2020121318A1 - Composition of multi-layered coating for balloon and process of coating thereof

Info

Publication number: WO2020121318A1
Application number: PCT/IN2019/050075
Authority: WO
Inventors: Deveshkumar Mahendralal KOTHWALA; Rajnikant Gandalal Vyas; Dr. Pramod Kumar MINOCHA
Original assignee: Meril Life Sciences Pvt. Ltd
Priority date: 2018-12-13
Filing date: 2019-02-01
Publication date: 2020-06-18

Abstract

A composition of multi-layered coating for balloon and process of coating thereof is disclosed. The composition of the multi-layered coating includes a base layer and a top layer. The base layer includes at least one hydrophilic compound in a concentration of 1.0%w/v to 5.0%w/v and at least one crosslinker in a concentration of 0.01% w/v to 0.09%w/v dissolved in at least two solvents. The top layer includes at least one hydrophobic compound in a concentration of 1.0%w/v to 13.0%w/v and at least one hydrophilic surfactant present in a concentration of 0.1%w/v to 1.6%w/v, dissolved in at least two solvents. The process of coating the multi-layered coating includes coating of a base layer followed by a primary heat curing step. Subsequently, the top layer is coated followed by a secondary heat curing step.

Description

COMPOSITION OF MULTI-LAYERED COATING FOR BALLOON AND PROCESS OF COATING

THEREOF

FIELD OF INVENTION

[1] The present invention relates to a coating composition, more specifically relates to a

composition of a coating to be applied on an intra-aortic balloon.

BACKGROUND

[2] Heart failure is a condition or process in which heart is unable to pump enough blood to meet the needs of body's tissues. The heart weakens over a course of months or years and becomes unable to pump out all the blood that enters its chambers. As a result, fluid starts to build up in lungs and other tissues, leading to congestion. Several medical devices such as cardiopulmonary bypass pumps/ ECMOs, internal or external counter-pulsation and/or various modes of auxiliary heart pumps have been in use to treat the aforesaid condition.

[3] Mechanical assistance may also be used for appropriate blood circulation through the

heart. One of the most common forms of the mechanical support may be an intra-aortic balloon pump (IABP).

[4] Conventionally, the IABP is made up of flexible thin-walled balloon which is inflatable

balloon mounted on a catheter device. The balloon is reached in deflated and furled condition to the aortic pumping site through a small puncture opening or through an introducer cannula into the selected artery. At the pumping site, balloon is unfurled and then sequentially and quickly inflated and deflated in synchronism with the patient's cardiac pulsation.

[5] However, IABP procedure requires insertion of relatively large balloon through small

opening of tortuous arterial lumens and therefore, it is advantageous that the furled balloon and catheter should be slippery during insertion for ease of insertion through small lumens and passage pathway. From the advent of IABP, numerous developments have been made in IABP which include smaller intra-aortic balloon (IAB) catheters and sheath-less insertion techniques. However, patients still experience complications during percutaneous IAB counter pulsation. Hydrophilic coating is widely applied to angioplasty catheters and guidewire to reduce the coefficient of friction. However, such coating can lead to the "self- adhesive" effect and become sticky which may damage the coating and performance of the balloon. [6] Hence, an intra-aortic balloon which has adequate lubricity to prevent fiction during operation of intra- aortic balloon and at the same time is dry enough to prevent damage due to too much moisture is required to be devised.

SUMMARY

[7] The present invention discloses a coating composition to be applied on the balloon surface.

An outer surface of the balloon is coated with at least two layers of the coating the two layers of the coating includes a base layer having one hydrophilic compound present in the concentration of 1.0%w/v to 5.0%w/v, one crosslinker present in the concentration of 0.01%w/v to 0.09%w/v prepared in a solvent. A top layer having one hydrophobic compound present in the concentration of 1.0%w/v to 13.0%w/v, one surfactant present in the concentration of 0.1%w/v to 1.6%w/v prepared in a solvent.

BRIEF DESCRIPTION OF THE DRAWINGS

[8] The summary above, as well as the following detailed description of illustrative

embodiments, is better understood when read in conjunction with the appended drawings. For the purpose of illustrating the present disclosure, exemplary constructions of the disclosure are shown in the drawings. However, the disclosure is not limited to specific methods and instrumentalities disclosed herein. Moreover, those in the art will understand that the drawings are not to scale.

[9] FIG.l represents a cross-sectional view of a balloon surface and coating layers in accordance with an embodiment of the present invention.

[10] FIG. 2 represents a flow chart depicting a process involved in coating of a balloon

surface in accordance with an embodiment of the present invention.

DETAILED DESCRIPTION OF THE DRAWINGS

[11] Prior to describing the invention in detail, definitions of certain words or phrases used throughout this patent document will be defined: the terms "include" and "comprise", as well as derivatives thereof, mean inclusion without limitation; the term "or" is inclusive, meaning and/or; the phrases "coupled with" and "associated therewith", as well as derivatives thereof, may mean to include, be included within, interconnect with, contain, be contained within, connect to or with, couple to or with, be communicable with, cooperate with, interleave, juxtapose, be proximate to, be bound to or with, have a property of, or the like; Definitions of certain words and phrases are provided throughout this patent document, and those of ordinary skill in the art will understand that such definitions apply in many, if not most, instances to prior as well as future uses of such defined words and phrases.

[12] Particular embodiments of the present disclosure are described herein below with

reference to the accompanying drawings, however, it is to be understood that the disclosed embodiments are merely examples of the disclosure, which may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail.

[IB] Therefore, specific structural and functional details disclosed herein are not to be

interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.

[14] In accordance with the present disclosure, an intra- aortic balloon (IAB) with a multi layered coating is disclosed. The IAB of the present invention may be used as a circulatory assist device in critically ill patients with cardiac disease. In an embodiment, the IAB is used to improve the ventricular performance of the heart by facilitating an increase in myocardial oxygen supply and a decrease in myocardial oxygen demand. The IAB may be deployed in a patient by means of a catheter.

[15] The multi-layered coating on the balloon of the present invention is dry and has

adequate lubricity. The lubricity of the multi-layered coating prevents friction during operation of intra- aortic balloon. Further, the multi-layered coating maintains its lubricity during long term storage. The multi-layered coating is dry enough to prevent damage to the intra-aortic balloon due to moisture. In an embodiment, the lubricity of the multi-layered coating ranges from 25g to 40g. Hence, the multi-layered coating imparts hydrophobicity, lubricity, abrasion resistance, and/or durability to the balloon. Moreover, the multi-layered coating remains intact during advancement of balloon to a treatment site. Further, the multi-layered coating may reduce complications such as without limitation difficulty in insertion of device in a patient, damage to tissue and blood vessel due to abrasion during insertion and/or removal of device during treatment. [16] In an embodiment, the multi-layered coating is applied as two separate layers i.e. a base layer and a top layer. The base layer may include a hydrophilic coating formulation. In an embodiment, the top layer may include a hydrophobic coating formulation. Hence, the base layer imparts lubricity to the multi-layered coating while the top layer helps to keep the multi-layered coating sufficiently dry.

[17] The multi-layered coating may be applied by layer by layer via dip coating process. Post coating each layer, the balloon may be employed for heat curing at a predefined

temperature and time. Heat curing enhances toughens and hardens the coated layers and enhances the durability and abrasion resistance of the intra-aortic balloon.

[18] Now referring specifically to drawings, FIG.l represents a schematic view of an intra aortic balloon 100 in accordance with an embodiment of the present invention. The intra aortic balloon 100 includes a balloon 10 with an outer surface 10a. The outer surface 10a of balloon 10 is coated with a multi-layered coating 10b. In an embodiment, the multi-layered coating includes two layers i.e. a base layer 103 and a top layer 105.

[19] The balloon 10 may be an expandable balloon known in the art. The balloon 10 may be made of a polymeric material. The polymeric material may include without limitation polypropylene (PP), polyetherimide (PEI), polyetheretherketone (PEEK), poly amides (nylon), and PEBAX^®, polyethylene, (PE), polyurethane (PU), polycarbonate (PC),

polyvinylchloride (PVC), polyethersulfone (PES) and a mixture thereof. In an embodiment, the balloon 100 is made of polyurethane. The balloon 10 may include a predefined shape and dimensions. The outer surface 10a of the balloon 10 may be a smooth surface or a pitted surface.

[20] In an embodiment, the base layer 103 includes a hydrophilic coating formulation. The composition of the hydrophilic coating formulation may include, one or more of, a hydrophilic compound and a cross linker dissolved in one or more solvents. The

concentration of the hydrophilic compound may be in a range of 1.0% w/v to 5.0%w/v. The concentration of the cross linker may be in a range of 0.01%w/v to 0.09%w/v.

[21] The hydrophilic compound(s) may be a hydrophilic polymer(s). The hydrophilic polymers may include, without limitation, poly-carboxyl acids and/or their derivatives,

polyvinylpyrrolidone (PVP), polyvinyl alcohol (PVA), amides of poly(meth)acrylic acid, cellulosic compound such as methyl cellulose, carboxy methyl cellulose, hydroxyl methyl cellulose, polyethyleneimines, polypeptides such as collagens, fibrins, and elastin, polysaccharides such as chitosan, hyaluronic acid, alginates, gelatin, and chitin, copolymers of poly (methyl vinyl ether/ maleic anhydride), pluronic, poloxamer 407 and polyglycols like polyethyleneglycol (PEG), polyesters such as polylactides, polyglycolides, and

polycaprolactones or mixture thereof.

[22] In an embodiment, polyvinylpyrrolidone (PVP K-90) is used. PVP is an inert, hydroscopic and amorphous polymer that is widely used as common organic plasticizer. The molecular weight of polyvinylpyrrolidone ranges from 5,00,000 g/mol to 22,00,000 g/mol, preferably ranges from 7,00,000 g/mol to 20,00,000 g/mol, and more preferably from 10,00,000 g/mol to 17,00,000 g/mol. The concentration of the polyvinylpyrrolidone (PVP K-90) may be in a range of 1.0%w/v to 5.0%w/v, preferably 2.5%w/v to 3.5%w/v, and more preferably 2.8%w/v to 3.3%w/v.

[23] The hydrophilic compound(s) in base layer 103 provides lubricity and friction resistance at the treatment site during balloon inflation and/or deflation. The presence of hydrophilic compounds ensures lubricity for easy passage of the intra-aortic balloon 100 and also reduces friction during implantation of the intra-aortic balloon 100. Further, the hydrophilic compound adheres to the balloon surface and acts as a support layer to firmly bind the top layer 105.

[24] Further, one or more cross linkers may be added to improve the abrasion resistance of the base layer 103. The cross linkers may be selected from one or more of epoxies, melamines, aziridines, isocyanates, dibutyltin dilaurate, Isophorone diisocyanate, hexamethylene diisocyanate, blocked isocyanates, carbodiimides, blocked melamines and their combination. In an embodiment, dibutyltin dilaurate is used as a cross-linker. The concentration of the crosslinker may be in a range of 0.01%w/v to 0.09%w/v, preferably 0.03%w/v to 0.07%w/v.

[25] The solvent(s) may provide a base for mixing the hydrophilic compound and the cross linker. The solvents may be selected from one or more of but not limited to, water, heptane, pentane, butane, methanol, 1-ethanol, 1-propanol, iso propyl alcohol, dimethyl sulfoxide (DMSO), N,N'-dimethylacetamide (DMAC), N-methyl-2-pyrrolidone (NMPO), 1,3- dimethyl-2-imidazolidinone (DMEU), methyl acetate, ethyl acetate, acetone, diethyl ether, xylene, and their mixtures. In an embodiment, a mixture of heptane and iso propyl alcohol is used as the solvent in a ratio ranging from 30:70 to 70:30, preferably 60:40 to 50:50. [26] In order to achieve sufficient lubricity to prevent friction during operation of intra aortic balloon 100 and to prevent damage to the intra-aortic balloon 100 due to moisture, the top layer 105 is coated over the base layer 103. Further, the top layer 105 prevents bridging and adhesion between abutting surfaces during wrapping/folding of the intra aortic balloon 100.

[27] In an embodiment, the top layer 105 comprises a hydrophobic coating. The top layer 105 may include one or more of a hydrophobic compound and a surfactant dissolved in a mixture of at least two solvents. The concentration of the hydrophobic compound may be in a range of 1.0%w/v to 13.0%w/v. The concentration of the surfactant may be in a range of 0.1%w/v to 1.6%w/v. The ratio of the solvent may be in a range of 60:40 to 50:50.

[28] The hydrophobic compound(s) may include silanes, silicone oil, fluorosilane,

alkanes, oils, fats, and greasy substances in general. Silanes are widely used as coating formulation component for achieving hydrophobic surface. Example of useful silanes may include octyltrichlorosilane, triacetoxy(methyl)silane, triacetoxy(vinyl)silane,

propyltrichlorosilane, hexadecyltrichlorosilane, 3-aminopropyltriethoxysilane, chloro- dimethyl-octadecylsilane, dimethoxymethyl-octadecylsilane, buthyltrimethoxysilane (BTMOS), Polydimethylsiloxane (PDMS), methyltrimethoxysilane (MTMOS), n- octylmethyldichlorosilane, tetramethoxysilane (TMOS), tetraethoxysilane (TEOS) or combinations thereof.

[29] In an embodiment, polydimethylsiloxane (PDMS) is used as a hydrophobic compound.

The polydimethylsiloxane is an optically clear, biocompatible, and biodurable hydrophobic compound having a molecular weight in a range of lOOg/mol to 270,000 g/mol. The viscosity of PDMS may range from 20cst to 12,000 cst, more preferably ranges from lOOcst to lOOOcst. In an embodiment, the concentration of the PDMS may be in a range of 1.0%w/v to 13.0%w/v, preferably from 4.0%w/v to 9.0%w/v, and more preferably 6.0%w/v to 7.0%w/v.

[30] The hydrophobic compound may limit moisture absorption by keeping the intra-aortic balloon 100 dry. Hence, the hydrophobic compound(s) prevent sticking of pleats during folding of intra-aortic balloon 100 and facilitate uniform opening of the intra-aortic balloon at the treatment site. Moreover, the hydrophobic compound may prevent excessive loss of hydrophilic constituent from the coating layer during transit of the balloon to treatment site. [31] In an embodiment, the surfactant is a hydrophilic surfactant. The addition of hydrophilic surfactant(s) in the top layer 105 provides sufficient lubricity for insertion and delivery of the intra-aortic balloon 100 at the treatment site. Further, the surfactant acts as a carrier to aid in removal of the top layer 105 upon entry of the intra-aortic balloon 100 into an aqueous environment i.e inside the body.

[32] The hydrophilic surfactant may include without limitation triton X-100, polysorbate, pluronic F 127, perfluorooctanesulfonate (PFOS), cetyl trimethylammonium chloride (CTAC), betaines. The hydrophilic surfactant may work as a carrier to aid removal of the top layer 105 upon entry into an aqueous environment. In an embodiment, pluronic F 127 is used as the hydrophilic surfactant. The concentration of the pluronic F 127 may be in a range of 0.1%w/v to 1.6%w/v, preferably 0.4%w/v to 1.2%w/v, and more 0.7%w/v to 1.0%w/v.

[33] The solvent(s) provides a base for mixing hydrophobic compound and the cross linker.

The solvent may be selected from, without limitation, water, heptane, pentane, butane, methanol, 1-ethanol, 1-propanol, iso propyl alcohol, dimethyl sulfoxide (DMSO), N,N'- dimethylacetamide (DMAC), N-methyl-2-pyrrolidone (NMPO), l,3-dimethyl-2- imidazolidinone (DMEU), methyl acetate, ethyl acetate, acetone, diethyl ether, xylene, and their mixtures. In an embodiment, a mixture of heptane and iso propyl alcohol is used as the solvent. The ratio of heptane and iso propyl alcohol may range from 30:70 to 70:30, more preferably 60:40 to 50:50.

[34] The multi-layered coating composed of the base layer 103 and the top layer 105, impart enough lubricity to the intra-aortic balloon 100 and reduce friction during treatment.

Further, the coating remains intact during advancement to a treatment site and during long storage of the intra-aortic balloon 100.

[35] In accordance with the present invention, FIG.2 represents a flow chart depicting a

process of manufacturing the intra -aortic balloon 100 with multi-layered coating. In an embodiment, the process commences at step 201. At step 201, the balloon 10 is fabricated. The balloon 10 may be made form any polymeric material may be fabricated by means of extruding a polymeric material via blow molding. In an alternate embodiment, the balloon 10 may be fabricated by means of dip molding.

[36] Following fabrication of the balloon 10 at the previous step, the base layer 103 is coated on the outer surface 10a of the balloon 10 at step 203. The coating of the balloon 10 may be performed by any process known in the art such as without limitation, spin coating, spray coating, rolling, sputtering, electro-spin coating, vapour deposition, dip coating, etc. In an embodiment, the balloon 10 is coated by means of dip coating. The dip coating is performed to achieve a simultaneous and uniform coating over the outer surface 10a.

[37] In an embodiment, the balloon 10 is immersed in the coating solution with a constant immersion speed of 5 mm/sec to 25 mm/sec, more preferably 10 mm/sec to 15 mm/sec. The balloon 10 may be withdrawn from the coating solution at a withdrawal speed of 1 mm/sec to 8 mm/sec, preferably 3 mm/sec to 6 mm/sec. In an embodiment, the coating thickness of the base layer 103 obtained is around 5pm to 80pm, preferably around 10pm to 50pm.

[38] At step 205, the base layer 103 is subjected to a primary heat curing process. In an embodiment, the primary heat curing process is performed at a first temperature in a range of 55°C to 65°C for a first time duration of 40 minutes to 80 minutes. In an embodiment, the primary heat curing is performed at a first temperature of 60°C for first time duration of 60 minutes. The primary heat curing process conducted at 60°C translates into better stability of the multi-layered coating and better long term performance. Further, the process of primary heat curing removes excess solvent from the outer surface 10a and improves wrapping characteristics of the balloon 10 without damaging the base layer 103.

[39] Following primary heat curing process, the top layer 105 is coated over the base layer 103 at step 207. The coating of the balloon 10 may be performed by any process known in the art such as without limitation, spin coating, spray coating, rolling, sputtering, electro spin coating, vapour deposition, dip coating. In an embodiment, the top layer 105 is coated by means of dip coating.

[40] In an embodiment, the balloon 10 is immersed in coating solution of the top layer 105 at a constant immersion speed of 5 mm/sec to 25 mm/sec, more preferably 10 mm/sec to 15 mm/sec. The balloon 10 may be withdrawn from the coating solution of the top layer 105 at a withdrawal speed of from 10 mm/sec to 40 mm/sec, more preferably ranges from 20 mm/sec to 30 mm/sec. In an embodiment, the coating thickness of the top layer 105 obtained may be around lOpm to 70pm, preferably around 20pm to 60pm.

[41] At step 209, following coating of the top layer 105, the top layer 105 is subjected to a secondary heat curing. The process of secondary heat curing of the top layer 105 may be performed for longer time duration as compared to the heat curing of the base layer 103 due to the presence of silicone in the top layer 105. In an embodiment, the secondary heat curing process is performed at a second temperature in a range of 55°C to 65°C for second time duration of 100 minutes to 140 minutes. In an embodiment, the secondary heat curing is performed for 120 minutes. The process of secondary heat curing may be performed to remove excess solvent from the outer surface, improvement of wrapping characteristics and performance of the balloon 10 without damaging the top layer 105.

[42] Optionally/additionally, at step 211, the balloon 10 is pleat folded and subjected to sterilization to yield the intra-aortic balloon 100. The sterilization may be performed by any means but not limited to ETO sterilization, radiation sterilization i.e., gamma or e-beam for sterilization. The process of ETO sterilization may depend upon various experimental factors such as pre-condition time, exposure time of ethylene oxide gas, degassing time and aeration time. In an embodiment, the ETO sterilization is used to sterilize the balloon 10 for time duration of 10 hours to 15 hours, preferably around 12 hours. The pre-condition time is in a range of 35 minutes to 115 minutes, preferably from 55 minutes to 95 minutes, and more preferably from 65 minutes to 85 minutes. The exposure time of ethylene oxide gas is in a range of 240 minutes to 400 minutes, preferably ranges from 270 minutes to 370 minutes, and more preferably ranges from 300 minutes to 340 minutes. Degassing time is in a range of 50 minutes to 230 minutes, preferably 100 minutes to 180 minutes, and more preferably 120 minutes to 160 minutes. Aeration time is in a range of 130minutes to 350minutes, preferably 180minutes to 300minutes, and more preferably 220minutes to 260minutes. The temperature during the sterilization process is in the range of 25°C to 58°C, and more preferably 35°C to 48°C. The relative humidity may range from 20% to 60%, more preferably ranges from 35% to 45%.

The invention is now explained with the help of following examples.

EXAMPLE 1

[43] In the present example, a balloon made of polymer is obtained. The balloon surface is coated with a base layer. The base layer formulation comprises an excipient, polyethylene oxide (PEO) in a concentration of 0.6%w/v and a crosslinker, dibutylin dilurate in a concentration of 0.02%w/v. The excipient and the crosslinker is dissolved in a solvent of n-

Heptane: Iso propyl alcohol (1:1). Further, the base layer is heat cured at a temperature of

50 ± 5 °C for around 300 minutes. Thereafter, a top layer is coated on the heat cured base layer. The formulation of the top layer comprises Polydimethyl siloxane (PDMS) in a concentration of 4.0%w/v in the solvent of n-Heptane: Iso propyl alcohol (1:1).

Subsequently, the top layer is heat cured at a temperature of 50 ± 5 °C for a time duration of around 120 minutes. Following heat curing of the top layer, the balloon is wrapped and coating lubricity of the balloon is analyzed by means of average tensile force testing. Higher the average tensile force of coating depicts poor lubricity of coating on balloon surface. In the present example, tensile force of coating is 42. Og to 50. Og and lubricity of coating is not adequate. Following, wrapping, the balloon is packed in a tyvek pouch and sterilized by EtO sterilization method. After sterilization of balloon, coating lubricity on balloon surface is analyzed by means of average tensile force testing. There is no significant change in the balloon average tensile force after EtO sterilization which indicates the robustness and durability of the coating on the balloon surface.

EXAMPLE 2

[44] In the present example, coating formulation of the base layer comprises a hydrophilic compound, PVP in a concentration of 3.0%w/v and a crosslinker, dibutylin dilurate in a concentration of 0.05%w/v. The hydrophilic compound and the crosslinker is dissolved in a solution of n-Heptane and Iso propyl alcohol (1:1). The base layer coating is performed by means of dip coating. Following coating, the base layer is heat cured at a temperature of 60 ± 5 °C for a time duration of around 60 minutes. Thereafter, a top layer is coated on the heat cured base layer. The formulation of the top layer comprises a hydrophilic surfactant, pluronic F 127 in a concentration of 0.75%w/v and a hydrophobic compound, Poly dimethyl siloxane in a concentration of 6.7%w/v. The hydrophilic surfactant and the hydrophobic compound is dissolved in a solvent of n-Heptane: Iso propyl alcohol (1:1). Subsequently, the top layer is heat cured at a temperature of 60 ± 5 °C for a time duration of around 120 minutes. Following heat curing of the top layer, the balloon is wrapped and coating lubricity of the balloon is analyzed by means of average tensile force testing. Lower the average tensile force of coating depict superior lubricity of coating on the balloon surface. In the present example, tensile force of coating is 28. Og to 35. Og and lubricity of coating is adequate. Following, wrapping, the balloon is packed in a tyvek pouch and sterilized by EtO sterilization method. After sterilization of balloon, coating lubricity on balloon surface is analyzed by means of average tensile force testing. There is no significant change in the balloon average tensile force after EtO sterilization which indicates the robustness and durability of the coating on the balloon surface.

[45] The scope of the invention is only limited by the appended patent claims. More

generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings of the present invention is/are used.

Claims

We claim

1. A composition of a multi-layered coating comprising: at least two layers coated over a balloon, the at least two layers including: a base layer, the base layer including at least one hydrophilic compound in a concentration of 1.0%w/v to 5.0%w/v, at least one crosslinker in a concentration of 0.01% w/v to 0.09%w/v dissolved in at least two solvents; and a top layer, the top layer including at least one hydrophobic compound in a concentration of 1.0%w/v to 13.0%w/v, at least one hydrophilic surfactant present in a concentration of 0.1%w/v to 1.6%w/v dissolved in at least two solvents.

2. The multi-layered coating as claimed in claim 1 wherein the at least one hydrophilic compound is selected from polyvinylpyrrolidone (PVP), polyvinyl alcohol (PVA), amides of poly(meth)acrylic acid, methyl cellulose, carboxy methyl cellulose, hydroxyl methyl cellulose, polyethyleneimines, polypeptides such as collagens, fibrins, and elastin, chitosan, hyaluronic acid, alginates, gelatin, and chitin, copolymers of poly (methyl vinyl ether/ maleic anhydride), pluronic, poloxamer 407 and polyglycols like

polyethyleneglycol (PEG), and polyesters or combinations thereof.

3. The multi-layered coating as claimed in claim 1 wherein the at least one crosslinker is selected from epoxies, melamines, aziridines, isocyanates, dibutyltin dilaurate,

Isophorone diisocyanate, Hexamethylene diisocyanate, blocked isocyanates, carbodiimides, blocked melamines or combinations thereof.

4. The coating on the balloon as claimed in claim 1 wherein the at least one hydrophobic compound is selected from octyltrichlorosilane, triacetoxy(methyl)silane,

triacetoxy(vinyl)silane, propyltrichlorosilane, hexadecyltrichlorosilane, 3- aminopropyltriethoxysilane, chloro-dimethyl-octadecylsilane, dimethoxymethyl- octadecylsilane, buthyltrimethoxysilane (BTMOS), polydimethylsiloxane (PDMS), methyltrimethoxysilane (MTMOS), n-octylmethyldichlorosilane, tetramethoxysilane (TMOS), tetraethoxysilane (TEOS) or combinations thereof.

5. The multi-layered coating as claimed in claim 1 wherein the at least one hydrophilic surfactant is selected from triton X-100, polysorbate, pluronic F 127,

perfluorooctanesulfonate (PFOS), cetyl trimethylammonium chloride (CTAC), betaines or combinations thereof.

6. The multi-layered coating as claimed in claim 1 wherein the at least two solvents are selected from water, heptane, pentane, butane, methanol, 1-ethanol, 1-propanol, iso propyl alcohol, dimethyl sulfoxide (DMSO), N,N'-dimethylacetamide (DMAC), N-methyl- 2-pyrrolidone (NMPO), l,3-dimethyl-2-imidazolidinone (DMEU), methyl acetate, ethyl acetate, acetone, diethyl ether, xylene, or mixture thereof.

7. A process for providing a multi-layered coating on a balloon, the process comprising: a. fabricating a balloon having an outer surface; b. coating a base layer on the outer surface of the balloon; c. performing primary heat curing of the base layer at a first temperature for a first time duration of 40 to 80 minutes to form a heat cured base layer; d. coating a top layer over the heat cured base layer of the balloon; and e. performing secondary heat curing of the top layer at a second temperature for a second time duration of 100 to 140 minutes to form an intra-aortic balloon.

8. The process as claimed in claim 7 wherein the fabricating the balloon includes

fabricating the balloon by means of blow molding or dip molding.

9. The process as claimed in claim 8 wherein the polymeric material is selected from

polypropylene (PP), polyetherimide (PEI), polyetheretherketone (PEEK), poly amides (nylon), and PEBAX^®, polyethylene, (PE), polyurethane (PU), polycarbonate (PC), polyvinylchloride (PVC), polyethersulfone (PES) or a mixture thereof.

10. The process as claimed in claim 7 wherein the coating is performed by dip coating

process.

11. The process as claimed in claim 7 wherein the first temperature and the second

temperature is in a range of 55°C to 65°C.