Selective drug delivery in a lumen

• US 9,327,100 B2
• Filed: 03/12/2013
• Issued: 05/03/2016
• Est. Priority Date: 11/14/2008
• Status: Active Grant

• Current Assignee: Vessix Vascular, Inc. (Boston Scientific Corporation)
• Original Assignee: Vessix Vascular, Inc. (Boston Scientific Corporation)
• Inventors: Perry, Michael, Stone, Corbett W., Schreiber, Ronda, Mazor, Meital, Conn, Brian D., Gustus, Rolfe Tyson
• Primary Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US13/796,777
• Publication Number:
  US 20130172815A1
• Time in Patent Office: 1,148 Days
• Field of Search: 600/381, 604/20, 604/21, 604/53, 604/96, 604/99, 60410301-10311, 604/265, 604/266, 606/27, 606/32, 606/192, 606/194
• US Class Current: 1/1
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2018/00154 containing and delivering drugs
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00898 Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 2018/1861 with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61L 2300/45 Mixtures of two or more drugs, e.g. synergistic mixtures
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 29/08 Materials for coatings
• CPC Class Codes: A61L 29/14 Materials characterised by their function or physical properties , e.g. lubricating compositions
• 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 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2025/1088 having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
• CPC Class Codes: 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
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
• CPC Class Codes: A61N 7/022 : intracavitary

Abstract

Methods and systems are disclosed for selective drug or fluid delivery in a lumen through a coating or fluid delivery channels. One system includes an elongate catheter having a proximal end and a distal end with an axis therebetween, the catheter having a radially expandable balloon near the distal end and an energy delivery portion proximate the balloon for transmission of energy, a thermally changeable coating having a releasable drug coupled to the balloon, the thermally changeable coating being oriented to be urged against the body tissue when the expandable balloon expands and an energy source operatively coupled to the energy delivery portion configured to energize the energy delivery portion to heat and liquefy the thermally changeable coating to release the drug to the body tissue.

Claims

1. A medical device, comprising:

a catheter shaft having a distal region;

an expandable member coupled to the distal region;

a coating disposed along the expandable member, the coating including a releasable drug;

a plurality of electrodes coupled to the expandable member;

wherein the plurality of electrodes includes one or more pairs of bipolar electrodes; and

wherein the electrodes are configured to induce a phase change in the coating and release the releasable drug from the coating.

2. The medical device of claim 1, wherein the expandable member includes a balloon.

3. The medical device of claim 2, wherein the electrodes are mounted to an outer surface of the balloon.

4. The medical device of claim 2, wherein the balloon is configured to be fully inflated with a pressure of 6 atmospheres or less.

5. The medical device of claim 2, wherein the balloon is configured to be fully inflated with a pressure of 1 to 2 atmospheres.

6. The medical device of claim 1, further comprising a generator coupled to the catheter shaft for selectively energizing the plurality of electrodes.

7. The medical device of claim 6, wherein the generator is configured to energize the electrodes for 1 to 180 seconds.

8. The medical device of claim 6, wherein the generator is configured to energize the electrodes with 0.25 to 5 Watts average power.

9. The medical device of claim 6, wherein the generator includes an RF energy source.

10. The medical device of claim 1, wherein at least some of the plurality of electrodes are configured to sense impedance.

11. The medical device of claim 1, wherein at least some of the plurality of electrodes are configured to characterize target tissue based on sensed impedance.

12. The medical device of claim 1, wherein the coating has coating melting temperature above 37°

Celsius.

13. The medical device of claim 1, wherein energizing the electrodes liquefies at least a portion of the coating.

14. A medical device, comprising:

a catheter shaft having a distal region;

a balloon coupled to the distal region;

a coating disposed on the balloon, the coating including a releasable drug;

one or more pairs of bipolar electrodes coupled to the balloon;

wherein the electrodes are configured to induce a phase change in the coating and release the releasable drug from the coating, wherein the phase change of the coating from a solid to a liquid releases the drug; and

a generator coupled to the catheter shaft, the generator being configured to selectively energize the electrodes.

15. The medical device of claim 14, wherein the generator includes an RF energy source.

16. The medical device of claim 14, wherein at least some of the one or more pairs of bipolar electrodes are configured to sense impedance and characterize target tissue based on sensed impedance.

17. The medical device of claim 14, wherein the coating has coating melting temperature above 37°

Celsius.

18. The medical device of claim 14, wherein energizing the electrodes liquefies at least a portion of the coating.

19. A medical device, comprising:

a catheter shaft having a distal region;

a balloon coupled to the distal region;

a thermally changeable coating disposed on the balloon, the coating including a releasable drug;

wherein the thermally changeable coating has a coating melting temperature above 37°

Celsius;

one or more pairs of bipolar electrodes coupled to the balloon;

wherein the electrodes are configured to heat the coating above the coating melting temperature so as to at least partially liquefy the coating and release the releasable drug from the coating; and

a generator coupled to the catheter shaft, the generator being configured to selectively energize the electrodes.