# US 2014/0155824 A1 · Drug Delivery Medical Devices

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- Number: US 2014/0155824 A1
- Document ID: US20140155824A1
- Status: Published application
- Kind: A1
- Application number: 14/176,980
- Filed: 2014-02-10
- Published: 2014-06-05
- Earliest claimed: 2007-06-25
- Assignees: Abbott Cardiovascular Systems Inc.
- Applicants: Abbott Cardiovascular Systems Inc.
- Inventors: John E. Papp
- Web page: https://patentgrep.com/patent/US20140155824A1

## CPC

- A61M 37/0015: {by using microneedles}
- 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 25/10185: {Valves}
- A61F 2/91: made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
- A61M 2025/105: {having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes}
- A61M 2025/1086: {having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves}
- A61M 2037/0023: {Drug applicators using microneedles}
- A61M 2037/003: {having a lumen}
- A61M 2037/0061: {Methods for using microneedles}
- 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)}
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

Medical devices for delivering a bioactive agent and methods of use thereof are provided. The device includes a balloon having micro-needles for delivery of the bioactive agent.

## Claims

### Claim 1

A medical device, comprising:
a catheter;
a balloon disposed at an end of the catheter, the balloon having a first balloon membrane and a second balloon membrane; and
micro-needles disposed in the first balloon membrane, the micro-needles including a hollow area in which a drug can reside, wherein the second balloon membrane is configured to penetrate into the hollow areas so as to push the drug out of the hollow area of the micro-needles for application of the drug to a tissue where the balloon has been positioned and expanded, and wherein the first balloon membrane is in fluid communication with a first fluid path for expansion of the first balloon membrane and the second balloon membrane is in fluid communication with a second fluid path, separate from the first fluid path, for expansion of the second balloon membrane into the hollow area to push the drug out of the hollow area of the micro-needles.

### Claim 2 (depends on 1)

The device of claim 1, wherein the first fluid path is operably controlled by a stop cock and a relief valve for maintaining a pressure against the first balloon membrane.

### Claim 3 (depends on 1)

The device of claim 1, wherein the second balloon membrane is in fluid communication with the second fluid path for expansion of the second balloon membrane to push the micro-needles into the tissue for delivery of the drug.

### Claim 4 (depends on 1)

The device of claim 1, wherein the first balloon membrane is configured to apply a pressure against a vessel wall when a pressure is applied inside of the balloon and the second balloon membrane is configured to push against ends of the micro-needles to cause the micro-needles to penetrate into the tissue.

### Claim 5 (depends on 1)

The device of claim 1, wherein the second balloon membrane is responsive to pressure to push the micro-needles into the tissue for delivery of the drug.

### Claim 6 (depends on 1)

The device of claim 1, wherein the micro-needles include a first conical shaped portion transitioning into a second conical shaped portion.

### Claim 7 (depends on 1)

The device of claim 1, wherein the micro-needles include a cylindrical portion and a conical shaped portion extending out from the cylindrical portion.

### Claim 8

A medical device, comprising:
a catheter;
a balloon disposed at an end of the catheter, the balloon having a first balloon membrane and a second balloon membrane; and
micro-needles disposed in the first balloon membrane, the micro-needles including a hollow area in which a drug can reside, wherein the second balloon membrane is configured to push the drug out of the hollow area of the micro-needles for application of the drug to a tissue where the balloon has been positioned and expanded, wherein the second balloon membrane resides within the hollow area of the micro-needles and functions as a piston-like device to push the drug out of the micro-needles upon application of a pressure to the second balloon membrane.

### Claim 9

A medical device, comprising:
a catheter;
a balloon disposed at an end of the catheter, the balloon having a first balloon membrane and a second balloon membrane; and
micro-needles disposed in the first balloon membrane, the micro-needles including a hollow area in which a drug can reside, wherein the second balloon membrane is configured to push the drug out of the hollow area of the micro-needles for application of the drug to a tissue where the balloon has been positioned and expanded wherein the second balloon membrane is a flexible membrane positioned beneath and in contact with the first balloon membrane, the first balloon membrane is configured to apply a pressure against a vessel wall when a pressure is applied inside of the balloon and the second balloon membrane is configured to penetrate into ends of the micro-needles when a pressure is applied inside of the balloon.
