# US 8,771,332 B2 · Multi-layer balloon design for use in combination with catheter assemblies, and methods of making the same

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- Number: US 8,771,332 B2
- Document ID: US8771332B2
- Status: Granted
- Kind: B2
- Application number: 12/129,210
- Filed: 2008-05-29
- Published: 2009-12-03
- Granted: 2014-07-08
- Earliest claimed: 2008-05-29
- Assignees: Boston Scientific Scimed, Inc.
- Applicants: Patricia Johnson; Sean O'Connor; Raymond Langan; Michael McGuinness; Kieran Kelly
- Inventors: Patricia Johnson; Sean O'Connor; Raymond Langan; Michael McGuinness; Kieran Kelly
- Web page: https://patentgrep.com/patent/US8771332B2

## CPC

- A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00})
- A61M 25/1029: {Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril}
- A61M 2025/1031: {Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface}
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

An expandable medical device having a static state and at least one expanded state, the expandable medical device in the static state including at least one first inner layer and at least one second outer layer, the outer layer having an inner surface and an outer surface, the outer layer having a closed lattice in the inner surface or the outer surface of the outer layer, wherein the lattice is open when the expandable medical device is in the at least one expanded state, and methods of making the same.

## Claims

### Claim 1

An expandable medical device having a static state and at least one expanded state, the expandable medical device in said static state comprising:
at least one first inner layer formed from a first polymer composition;
at least one intermediate layer; and
at least one second outer layer formed from a second polymer composition which is the same as or different than said first polymer composition, said at least one second outer layer having an inner surface and an outer surface and the at least one second outer layer comprising a closed lattice in said inner surface or said outer surface of said at least one second outer layer, the closed lattice is defined by channels having a thinner wall than corresponding areas of the outer surface; and
wherein said lattice is closed in said static state and said at least one intermediate layer is unexposed and said lattice is open when said expandable medical device is in said at least one expanded state, exposing said intermediate layer.

### Claim 2 (depends on 1)

The expandable medical device of claim 1 wherein said at least one intermediate layer comprises at least one lubricious polymer material, at least one therapeutic agent or a combination thereof.

### Claim 3 (depends on 1)

The expandable medical device of claim 1 wherein said at least one intermediate layer comprises a lubricious gel.

### Claim 4 (depends on 3)

The expandable medical device of claim 3 wherein said lubricious gel is a hydrogel.

### Claim 5 (depends on 1)

The expandable medical device of claim 1 wherein said at least one intermediate layer comprises at least one therapeutic agent.

### Claim 6 (depends on 1)

The expandable medical device of claim 1 wherein first polymer composition comprises a polyether-block-amide copolymer.

### Claim 7 (depends on 1)

The expandable medical device of claim 1 wherein said closed lattice is in said outer surface of said at least one second outer layer.

### Claim 8 (depends on 1)

The expandable medical device of claim 1 in combination with a catheter assembly, the catheter assembly having a distal end, the expandable medical device disposed on the distal end of said catheter assembly.

### Claim 9 (depends on 1)

The expandable medical device of claim 1 in combination with a stent, said stent disposed on said expandable medical device.

### Claim 10 (depends on 1)

The expandable medical device of claim 1, the device comprising cone, waist and body portions, the intermediate layer is on the body portion of the device.

### Claim 11

An expandable medical device for the controlled, localized delivery of a therapeutic agent, said expandable medical device having at least one static state and at least one expanded state, said expandable medical device comprising:
at least one first inner layer formed from a first polymer composition;
at least one second outer layer formed from a second polymer composition which is the same as or different than said first polymer composition, said at least one second outer layer having an inner surface and an outer surface and the at least one second outer layer comprising a closed lattice in said inner surface or said outer surface of said at least one second outer layer, the closed lattice is defined by channels having a thinner wall than corresponding areas of the outer surface; and
an intermediate layer, said intermediate layer comprising at least one therapeutic agent;
wherein said lattice is closed in said static state and said intermediate layer is unexposed and said lattice is open when said expandable medical device is in said at least one expanded state, exposing said intermediate layer for delivery of said at least one therapeutic agent.

### Claim 12

An expandable medical device for the delivery of an implantable medical device, said expandable medical device having a static state, at least one expanded state and at least one deflated state, said expandable medical device disposed at the distal end of a catheter assembly, said implantable medical device disposed about said expandable medical device when said expandable medical device is in said at least one deflated state, said expandable medical device comprising:
at least one first inner layer formed from a first polymer composition;
at least one second outer layer formed from a second polymer composition which is the same as or different than said first polymer composition, said at least one second outer layer having an inner surface and an outer surface and the at least one second outer layer comprising a closed lattice in said inner surface or said outer surface of said at least one second outer layer, the closed lattice is defined by channels having a thinner wall than corresponding areas of the outer surface; and
an intermediate layer, said intermediate layer comprising at least one lubricious polymer material;
wherein in said static state said lattice is closed and said intermediate layer is unexposed and said lattice is open when said expandable medical device is in said at least one expanded state, exposing said intermediate layer.

### Claim 13

An expandable medical device having a static state and at least one expanded state, the expandable medical device in said static state comprising:
at least one first inner layer formed from a first polymer composition; and
at least one second outer layer formed from a second polymer composition which is the same as or different than said first polymer composition, said at least one second outer layer having an inner surface and an outer surface and the at least one second outer layer comprising a closed lattice in said inner surface or said outer surface of said at least one second outer layer, the closed lattice is defined by channels having a thinner wall than corresponding areas of the outer surface;
said lattice is open when said expandable medical device is in said at least one expanded state; and
wherein fluid is prevented from flowing through the outer surface or inner surface of the at least one second outer layer when the lattice is closed and wherein fluid can flow through said outer surface of inner surface of said outer layer at least one second when said lattice is open.
