# US 9,039,748 B2 · Method of securing a medical device onto a balloon and system thereof

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- Number: US 9,039,748 B2
- Document ID: US9039748B2
- Status: Granted
- Kind: B2
- Application number: 12/419,617
- Filed: 2009-04-07
- Published: 2010-03-18
- Granted: 2015-05-26
- Earliest claimed: 2008-04-07
- Assignees: Abbott Cardiovascular Systems Inc.
- Applicants: Keith R. Cromack; Donald Verlee
- Inventors: Keith R. Cromack; Donald Verlee
- Web page: https://patentgrep.com/patent/US9039748B2

## CPC

- A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)}
- A61L 29/085: {Macromolecular materials}
- B29C 65/483: {Reactive adhesives, e.g. chemically curing adhesives}
- A61L 2300/00: Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- B29C 35/02: Heating or curing, e.g. crosslinking or vulcanizing {during moulding, e.g. in a mould}(cold vulcanisation B29C35/18 {; vulcanising tyres, presses therefor B29D30/0601})
- B29C 65/4835: {Heat curing adhesives}
- B29C 65/4895: {Solvent bonding, i.e. the surfaces of the parts to be joined being treated with solvents, swelling or softening agents, without adhesives}
- B29C 65/52: {characterised by the way of} applying the adhesive {(B29C65/50 takes precedence; apparatus for applying liquids in general B05C; processes for applying liquids in general B05D)}
- B29C 66/71: {characterised by the composition of the plastics material of the parts to be joined (welding bar compositions B29C65/125)}
- B29C 66/73791: {biodegradable}
- B29C 66/73793: {soluble, e.g. water-soluble}
- B29K 2023/00: Use of polyalkenes {or derivatives thereof} as moulding material
- B29K 2023/16: {EPM, i.e. ethylene-propylene copolymers; EPDM, i.e. ethylene-propylene-diene copolymers; EPT, i.e. ethylene-propylene terpolymers}
- B29K 2027/12: containing fluorine
- B29K 2067/00: Use of polyesters {or derivatives thereof}, as moulding material
- B29K 2067/006: {PBT, i.e. polybutylene terephthalate}
- B29K 2067/046: {PLA, i.e. polylactic acid or polylactide}
- B29K 2071/00: Use of polyethers {, e.g. PEEK, i.e. polyether-etherketone or PEK, i.e. polyetherketone or derivatives thereof}, as moulding material
- B29K 2075/00: Use of {PU, i.e.} polyureas or polyurethanes {or derivatives thereof}, as moulding material
- B29K 2077/00: Use of {PA, i.e.} polyamides, e.g. polyesteramides {or derivatives thereof}, as moulding material
- B29K 2079/08: {PI, i.e. polyimides or derivatives thereof}
- B29K 2083/00: Use of polymers having silicon, with or without sulfur, nitrogen, oxygen, or carbon only, in the main chain, as moulding material
- B29K 2101/10: Thermosetting resins
- B29K 2101/12: Thermoplastic materials
- B29K 2305/00: Use of metals, their alloys or their compounds, as reinforcement
- B29L 2023/007: {Medical tubes other than catheters (catheters B29L2031/7542)}
- B29L 2031/7542: {Catheters}
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00)
- B29K: INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR {MOULDS, } REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29L: INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES

## Abstract

A method for securing an implantable medical device onto a balloon which includes applying a coating, which includes a film-forming polymer and at least one solvent, to the outer surface of the balloon. The solvents can include alcohol, water, ether and combinations thereof. The film-forming polymer can include a zwitterionic polymer, such as, for example a phosphorylcholine polymer. The coating can be applied to the entire balloon surface or a portion of the surface. The implantable medical device is then positioned on the outer surface of the balloon and secured. The film-forming polymer is then allowed to cure in order to define an adhesive layer between an inner surface of the implantable medical device and the outer surface of the balloon. This method prevents or reduces the leaching or redistribution of any therapeutic agents dispersed within or on the surface of the implantable medical device.

## Claims

### Claim 1

A method for securing an implantable medical device onto a balloon, the method comprising:
applying a coating to at least a portion of an outer surface of the balloon, the coating comprising a film-forming polymer and at least a first solvent;
curing the film-forming polymer coating to define a solid, adherent layer on the outer surface of the balloon;
positioning an implantable medical device on the solid, adherent layer, the implantable medical device including at least one therapeutic agent on at least a portion thereof;
securing the implantable medical device on the surface of the balloon; and
applying at least a second solvent to at least a portion of the secured implantable medical device and of the balloon to partially dissolve the solid, adherent layer between an inner surface of the implantable medical device and the outer surface of the balloon to define an adhesive layer disposed between the inner surface of the implantable medical device and the outer surface of the balloon, with reduced leaching of the therapeutic agent from the implantable medical device to the adhesive layer, wherein the at least first solvent is the same as or different from the at least second solvent.

### Claim 2 (depends on 1)

The method of claim 1, wherein the implantable medical device is positioned on the surface of the balloon before the coating is dried.

### Claim 3 (depends on 1)

The method of claim 1, wherein the implantable medical device is positioned on the surface of the balloon after the coating is dried.

### Claim 4 (depends on 1)

The method of claim 1, wherein the film-forming polymer is cured by heating.

### Claim 5 (depends on 1)

The method of claim 1, wherein the at least first solvent and at least second solvent are selected from the group consisting of, alcohol, water, ether, alkane, and mixtures thereof.

### Claim 6 (depends on 1)

The method of claim 1, wherein at least a portion of the inner surface of the implantable medical device also includes the coating.

### Claim 7 (depends on 1)

The method of claim 1, wherein the film-forming polymer is a zwitterionic polymer.

### Claim 8 (depends on 7)

The method of claim 7, wherein the film-forming polymer is a phosphorylcholine polymer.

### Claim 9 (depends on 7)

The method of claim 7, wherein the film-forming polymer is selected from the group consisting of amino acids, non-ionic hydrophilics, ionic hydrophilics, waxes, hydrophobics, aliphatic polyesters, and any combination thereof.

### Claim 10 (depends on 1)

The method of claim 1, wherein the at least first solvent in the coating comprises two solvents.

### Claim 11 (depends on 1)

The method of claim 1, wherein the implantable medical device is a stent or graft.

### Claim 12 (depends on 1)

The method of claim 1, wherein the at least one therapeutic agent is selected from the group consisting of anti-proliferative agents, anti-platelet agents, anti-inflammatory agents, anti-thrombotic agents and thrombolytic agents.

### Claim 13 (depends on 1)

The method of claim 1, wherein the curing step includes removal of the at least first solvent from the coating.

### Claim 14 (depends on 13)

The method of claim 13, wherein removal of the at least first solvent occurs by evaporation.

### Claim 15 (depends on 1)

The method of claim 1, wherein the film-forming polymer is biodegradable or bioresorbable.

### Claim 16

A method for securing an implantable medical device onto a balloon, the method comprising:
applying a coating to at least a portion of an outer surface of a balloon, the coating comprising a film-forming polymer and at least a first solvent;
positioning an implantable medical device onto the outer surface of the balloon;
securing the implantable medical device on the surface of the balloon;
introducing at least a second solvent to at least a portion of the secured implantable medical device and of the balloon after applying the coating to dissolve the film forming polymer between an inner surface of the implantable medical device and the outer surface of the balloon, wherein the at least first solvent is the same as or different from the at least second solvent; and
curing the film-forming polymer coating to define an adhesive layer between the inner surface of the implantable medical device and the outer surface of the balloon.

### Claim 17 (depends on 16)

The method of claim 16, wherein the at least second solvent is spray coated on the surface of the secured implantable medical device and balloon.

### Claim 18 (depends on 16)

The method of claim 16, wherein the at least second solvent is introduced as a vapor or mist.

### Claim 19 (depends on 16)

The method of claim 16, wherein at least a portion of the inner surface of the implantable medical device includes the coating.

### Claim 20 (depends on 16)

The method of claim 16, wherein the film-forming polymer is cross-linkable.

### Claim 21 (depends on 20)

The method of claim 20, wherein the curing step includes a step of cross-linking the polymer.

### Claim 22 (depends on 16)

The method of claim 16, wherein at least a portion of an outer surface of the implantable medical device includes a therapeutic agent.
