Drug delivery shock wave balloon catheter system

• US 10,441,300 B2
• Filed: 04/19/2017
• Issued: 10/15/2019
• Est. Priority Date: 04/19/2017
• Status: Active Grant

• Current Assignee: Shockwave Medical, Incorporated
• Original Assignee: Shockwave Medical, Incorporated
• Inventors: Hawkins, Daniel
• Primary Examiner(s): Stigell, Theodore J
• Application Number:
  US15/491,408
• Publication Number:
  US 20180303501A1
• Time in Patent Office: 909 Days
• CPC Class Codes: A61B 17/2202 the ultrasound transducer being inside patient's body at the distal end of the catheter
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00703 correcting for movement of heart, e.g. ECG-triggered
• CPC Class Codes: A61B 2017/22021 electric leads passing through the catheter
• CPC Class Codes: A61B 2017/22024 with a part reflecting mechanical vibrations, e.g. for focusing
• CPC Class Codes: A61B 2017/22025 applying a shock wave A61B2017/22091 takes precedence
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2017/22062 to be filled with liquid
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2017/22088 ultrasound absorbing, drug activated by ultrasound
• CPC Class Codes: 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
• CPC Class Codes: A61K 47/6957 the form being a device or a kit, e.g. stents or microdevices
• CPC Class Codes: A61L 2300/622 Microcapsules
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis

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

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.

2. 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.

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

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

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

6. 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.