Drug delivery shockwave balloon catheter system

• US 9,180,280 B2
• Filed: 10/19/2009
• Issued: 11/10/2015
• Est. Priority Date: 11/04/2008
• Status: Active Grant

• Current Assignee: Shockwave Medical, Incorporated
• Original Assignee: Shockwave Medical, Incorporated
• Inventors: Hawkins, Daniel, Adams, John M.
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Zhang, Jenna
• Application Number:
  US12/581,295
• Publication Number:
  US 20100114065A1
• Time in Patent Office: 2,213 Days
• Field of Search: 604/103.02, 604/22, 604/509
• US Class Current: 1/1
• 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 17/22022 using electric discharge
• CPC Class Codes: A61B 17/22029 Means for measuring shock waves
• CPC Class Codes: A61B 17/2256 with means for locating or checking the concrement, e.g. X-ray apparatus, imaging means A61B17/2255 takes precedence
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/22024 with a part reflecting mechanical vibrations, e.g. for focusing
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2017/22088 ultrasound absorbing, drug activated by ultrasound
• 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 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/1006 Balloons formed between concentric tubes
• CPC Class Codes: A61M 25/104 used for angioplasty

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 by the shock waves.

Claims

1. A catheter comprising:

an elongated carrier;

a balloon carried by the elongated carrier in sealed relation thereto, the balloon having an outer surface and being arranged to receive fluid therein that inflates the balloon;

a shock wave generator including a pair of electrodes located within the balloon, said pair of electrodes configured so that when a high voltage pulse is delivered thereto, a plasma arc is created which in turn creates a mechanical shock wave within the balloon; and

a medicinal agent attached to the outer surface of the balloon, the medicinal agent being releasable from the outer surface of the balloon in response to the shock wave created within the balloon,

wherein, the outer surface of the balloon remains sealed both during and after the creation of the shock wave and the release of the medicinal agent from the outer surface of the balloon.

2. The catheter of claim 1, wherein the medicinal agent is contained within a plurality of microspheres attached to the outer surface of the balloon.

3. The catheter of claim 2, wherein the plurality of microspheres have a diameter of between about 2 microns and about 100 microns.

4. The catheter of claim 1, wherein the medicinal agent is contained within a plurality of microcapsules attached to the outer surface of the balloon, wherein the medicinal agent is releasable from the plurality of microcapsules in response to the shock wave.

5. The catheter of claim 4, wherein the plurality of microcapsules have a diameter of between about 2 microns and about 100 microns.

6. The catheter of claim 4, wherein the plurality of microcapsules are arranged to crack open in response to the shock wave.

7. The catheter of claim 4, wherein the plurality of microcapsules comprise a polymer.

8. The catheter of claim 4, wherein the plurality of microcapsules comprise a starch.

9. The catheter of claim 4, wherein the plurality of microcapsules comprise glucose.

10. The catheter of claim 1, wherein the medicinal agent is in the form of a layer of a drug bonded to the balloon outer surface.

11. The catheter of claim 1, wherein the balloon is a dilation balloon.

12. The catheter of claim 1, wherein the elongated carrier includes a guide wire lumen.

13. A method comprising:

providing a catheter comprising an elongated carrier, a balloon carried by the elongated carrier in sealed relation thereto, a shock wave generator within the balloon, a medicinal agent attached to an outer surface of the balloon,

inserting the catheter into a blood vessel to be treated;

inflating the balloon with a liquid; and

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 to release the medicinal agent from the outer surface of the balloon with the outer surface of the balloon remaining sealed both during and after the creation of the shock wave and the release of the medicinal agent from the outer surface of the balloon.

14. The method of claim 13, wherein the medicinal agent is contained within a plurality of microspheres.

15. The method of claim 14, wherein the plurality of microspheres have a diameter of between about 2 microns and about 100 microns.

16. The method of claim 13, wherein the medicinal agent is contained within a plurality of microcapsules having a drug therein, wherein the drug is releasable from the plurality of microcapsules in response to the shock wave.

17. The method of claim 16, wherein the plurality of microcapsules have a diameter of between about 2 microns and about 100 microns.

18. The method of claim 16, wherein the mechanical shock wave generates sufficient energy to cause the plurality of microcapsules to crack open to release the drug.

19. The method of claim 16, wherein the plurality of microcapsules comprise a polymer.

20. The method of claim 16, wherein the plurality of microcapsules comprise a starch.

21. The method of claim 16, wherein the plurality of microcapsules comprise glucose.

22. The method of claim 13, wherein the medicinal agent is in the form of a layer of a drug bonded to the balloon outer surface.

23. The method of claim 13, further including the step of placing the balloon into a vessel or artery before inflating the balloon, wherein the balloon is a dilation balloon, and wherein the inflating step includes dilating the vessel or artery.