# US 10,441,300 B2 · Drug delivery shock wave balloon catheter system

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- Number: US 10,441,300 B2
- Document ID: US10441300B2
- Status: Granted
- Kind: B2
- Application number: 15/491,408
- Filed: 2017-04-19
- Published: 2018-10-25
- Granted: 2019-10-15
- Earliest claimed: 2017-04-19
- Assignees: Shockwave Medical, Inc.
- Applicants: Shockwave Medical, Inc.
- Inventors: Daniel Hawkins
- Web page: https://patentgrep.com/patent/US10441300B2

## CPC

- A61B 17/2202: {the ultrasound transducer being inside patient's body at the distal end of the catheter}
- A61K 41/0028: {Disruption, e.g. by heat or ultrasounds, sonophysical or sonochemical activation, e.g. thermosensitive or heat-sensitive liposomes, disruption of calculi with a medicinal preparation and ultrasounds}
- A61K 47/6957: {the form being a device or a kit, e.g. stents or microdevices}
- A61L 29/16: Biologically active materials, e.g. therapeutic substances {(A61L29/048 takes precedence)}
- A61M 25/104: {used for angioplasty}
- A61B 2017/003: {Steerable}
- A61B 2017/00703: {correcting for movement of heart, e.g. ECG-triggered}
- A61B 2017/22021: {electric leads passing through the catheter}
- A61B 2017/22024: {with a part reflecting mechanical vibrations, e.g. for focusing}
- A61B 2017/22025: {applying a shock wave (A61B2017/22091 takes precedence)}
- A61B 2017/22061: {for spreading elements apart}
- A61B 2017/22062: {to be filled with liquid}
- A61B 2017/22084: {stone- or thrombus-dissolving}
- A61B 2017/22088: {ultrasound absorbing, drug activated by ultrasound}
- A61L 2300/622: Microcapsules
- A61M 37/0092: {using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis}
- A61M 2025/105: {having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- 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)
- 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

A catheter comprises an elongated carrier and a balloon carried by the carrier in sealed relation thereto. The balloon has an outer surface and is arranged to receive a fluid therein that inflates the balloon. The catheter further comprises a shock wave generator within the balloon that forms mechanical shock waves within the balloon, and a medicinal agent carried on the outer surface of the balloon. The medicinal agent is releasable from the balloon either before or in response to the shock wave.

## Claims

### Claim 1

A method comprising:
providing a catheter having an elongated carrier, a balloon carried by the elongated carrier in sealed relation thereto, a shock wave generator within the balloon, and a medicinal agent applied to the outer surface of the balloon;
inserting the catheter into a blood vessel to be treated;
inflating the balloon with a liquid to a pressure between 1 to 4 atmospheres to cause a release of the medicinal agent from the balloon;
generating a shock wave within the balloon to crack calcified lesions in the vessel and facilitate uptake of the medicinal agent into the blood vessel with the balloon remaining sealed both during and after the creation of the shock wave; and
after the generating step, further inflating the balloon with the liquid to further release the medicinal agent.

### Claim 2 (depends on 1)

The method of claim 1 wherein said shock wave is generated by supplying a high voltage pulse to a pair of electrodes located within the balloon to produce a plasma arc which in turn creates a mechanical shock wave within the balloon.

### Claim 3 (depends on 1)

The method of claim 1 wherein the medicinal agent is in the form of a drug coated on the outer surface of the balloon.

### Claim 4 (depends on 1)

The method of claim 1 wherein the medicinal agent is coated on the outer surface of the balloon with an excipient.

### Claim 5 (depends on 1)

The method of claim 1, wherein the medicinal agent is contained within a plurality of microspheres.

### Claim 6 (depends on 1)

The method of claim 1, wherein the medicinal agent is a drug contained within a plurality of microcapsules, wherein the drug is releasable from the plurality of microcapsules in response to the shock wave.