Selective drug delivery in a lumen

• US 8,396,548 B2
• Filed: 11/11/2009
• Issued: 03/12/2013
• Est. Priority Date: 11/14/2008
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Vessix Vascular, Inc. (Boston Scientific Corporation)
• Inventors: Perry, Mike, Stone, Corbett W., Gustus, Rolfe Tyson, Schreiber, Ronda, Mazor, Meital, Conn, Brian
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US12/616,720
• Publication Number:
  US 20100125239A1
• Time in Patent Office: 1,217 Days
• Field of Search: 600/381, 604/20, 604/21, 604/53, 604/96, 604/99, 604/101, 604/101.04, 60410301-10311, 604/265, 604/266, 604/509, 604/890.1, 604/892.1, 606/27, 606/32, 606/192, 606/194
• US Class Current: 604/21
• 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 catheter system for selective drug delivery to a body tissue being disposed about a lumen, the system comprising:

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, wherein the energy delivery portion comprises a plurality of electrodes mounted on a surface of the expandable balloon;

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 plurality of electrodes with a controller configured to selectively energize one or more electrodes of the plurality of electrodes to selectively heat and liquefy a portion of the thermally changeable coating to release the drug to the body tissue, wherein the portion is less than the entire coating,

wherein the plurality of electrodes comprise a plurality of bipolar electrode pairs disposed about the expandable balloon, the controller configured to selectively energize selected electrode pairs of the plurality to heat and liquefy portions of the thermally changeable coating between the electrode pairs to release the drug to the body tissue.

2. The system of claim 1, wherein the body tissue of the lumen includes a diseased portion and select electrode pairs are energized to selectively heat the thermally changeable coating proximate the diseased portion.

3. The system of claim 1, wherein the energy delivery portion comprises a plurality of electrodes disposed about the expandable balloon so as to define a plurality of remodeling zones in the tissue when the balloon is expanded within the lumen, the electrodes being radially coupled with the tissue so that energy is transmitted between the electrodes and the tissue.

4. The system of claim 1, further comprising a tissue analyzer configured to characterize the body tissue using the plurality of electrodes.

5. The system of claim 4, wherein the controller is configured to selectively energize the one or more electrodes to heat the thermally changeable coating to release the drug in response to a characterization of the body tissue by the tissue analyzer.

6. The system of claim 1, wherein the energy delivery portion is energized to heat the body tissue before, during and/or after the drug delivery.

7. The system of claim 1, wherein the thermally changeable coating includes more than one releasable drug.

8. The system of claim 1, wherein the drug includes any of a lubricant to allow higher temperatures without sticking, an electrically conductive compound to lower the impedance at an electrode, an electrically insulating compound to prevent treatment to tissue that does not need treatment, an electrically conductive compound that is intended to migrate through the endothelial layers of tissue to carry energy to the interstitial layers, or a combination of the above.

9. The system of claim 1, wherein the energy source is a RF energy source and the energy delivery portion is configured to transmit RF energy.

10. A method for selective drug delivery in a lumen, the method comprising:

engaging a body tissue disposed about the lumen with a thermally changeable coating having a releasable drug disposed on a radially expandable balloon near a distal end of a catheter when the expandable balloon expands, wherein the balloon includes an energy delivery portion comprising a plurality of electrodes mounted on a surface of the balloon;

selectively energizing one or more electrodes of the plurality of electrodes so as to heat and liquefy a select portion of the thermally changeable drug coating, wherein the portion is less than the entire coating; and

releasing the drug from the heated portion of the thermally changeable coating into the body tissue,

wherein the plurality of electrodes comprises a plurality of bipolar electrode pairs disposed about the expandable balloon and selectively energizing one or more electrodes comprises selectively energizing selected electrode pairs of the plurality so as to heat and liquefy portions of the thermally changeable drug coating between the selected electrode pairs.

11. The method of claim 10, wherein the body tissue of the lumen includes a diseased portion and select electrode pairs are energized to heat the thermally changeable coating proximate the diseased portion.

12. The method of claim 10, further comprising characterizing the body tissue using the plurality of electrodes to identify body tissue to be treated and selectively heating portions of the thermally changeable coating to release the drug in response to the characterized body tissue to treat the identified body tissue.

13. The method of claim 10, further comprising heating the body tissue before, during and/or after the drug delivery.

14. The method of claim 10, wherein the drug includes any of a lubricant to allow higher temperatures without sticking, an electrically conductive compound to lower the impedance at an electrode, an electrically insulating compound to prevent treatment to tissue that does not need treatment, an electrically conductive compound that is intended to migrate through the endothelial layers of tissue to carry energy to the interstitial layers, or a combination of the above.

15. The method of claim 10, wherein the energy delivery portion is energized with RF energy.

16. A catheter system for drug delivery to a body tissue being disposed about a lumen, the system comprising:

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, wherein the energy delivery portion comprises a plurality of electrodes mounted on a surface of the balloon;

a plurality of biomolecules having a thermally releasable drug component and an inert component covalently bound to the balloon; and

an energy source operatively coupled to the plurality of electrodes with a controller configured to selectively heat a select portion of the balloon and the associated biomolecules coupled thereto so as to release the drug portion to the body tissue, wherein the portion is less than the entire balloon,

wherein the plurality of electrodes comprises a plurality of bipolar electrodes disposed about the expandable balloon, the controller configured to selectively energize selected electrode pairs to heat portions of the balloon between the selected electrode pairs so as to heat the associated biomolecules to release the drug portion to the body tissue.

17. The system of claim 16, wherein the body tissue of the lumen includes a diseased portion and select electrode pairs are energized to selectively heat the biomolecules proximate the diseased portion.

18. The system of claim 16, wherein the biomolecules are oriented to be urged against the body tissue when the expandable balloon expands.

19. The system of claim 16, further comprising a tissue analyzer configured to characterize the body tissue using the plurality of electrodes.

20. The system of claim 19, wherein the controller is configured to selectively energize the one or more electrodes to heat the biomolecules to release the drug component in response to a characterization of the body tissue by the tissue analyzer.

21. The system of claim 16, wherein the energy delivery portion is energized to heat the body tissue before, during and/or after the drug delivery.

22. The system of claim 16, wherein the biomolecules include more than one releasable drug.

23. The system of claim 16, wherein the drug portion includes any of a lubricant to allow higher temperatures without sticking, an electrically conductive compound to lower the impedance at an electrode, an electrically insulating compound to prevent treatment to tissue that does not need treatment, an electrically conductive compound that is intended to migrate through the endothelial layers of tissue to carry energy to the interstitial layers, or a combination of the above.

24. A method for drug delivery in a lumen, the method comprising:

engaging a body tissue disposed about the lumen with a plurality of biomolecules having a thermally releasable drug component and an inert component covalently bound to the balloon near a distal end of a catheter when the expandable balloon expands, wherein the balloon includes an energy delivery portion comprising a plurality of electrodes mounted to a surface of the balloon;

selectively energizing one or more electrodes of the plurality so as to heat a select portion of the balloon and the associated biomolecules bound thereto, the select portion being less than the entire balloon; and

releasing the drug component from the biomolecules into the body tissue,

wherein the plurality of electrodes comprises a plurality of bipolar electrode pairs disposed about the expandable balloon and wherein selectively energizing the one or more electrodes comprises selectively energizing select electrode pairs of the plurality so as to heat the biomolecules in the portion of the balloon between the select electrode pairs to release the drug component in the portion to the body tissue.

25. The method of claim 24, further comprising heating the body tissue before, during and/or after the drug delivery.

26. The method of claim 24, further comprising characterizing the body tissue with the plurality of electrodes to identify body tissue to be treated and selectively energizing the one or more electrodes to heat the biomolecules to release the drug portion in response to the characterized body tissue to treat the identified body tissue.

27. A catheter system for selective fluid delivery to a body tissue being disposed about a lumen, the system comprising:

an elongated flexible catheter body having a proximal end and a distal end;

a radially expandable structure near the distal end of the catheter body having a plurality of electrodes mounted thereon;

a plurality of fluid delivery channels oriented to be urged against the body tissue when the expandable structure expands, the fluid delivery channels being initially blocked with a thermally changeable material; and

an energy source connector operatively coupled to the plurality of electrodes proximate the fluid delivery channels with a controller configured to selectively energize one or more electrodes of the plurality so as to heat and liquefy the thermally changeable material to selectively open a portion of the fluid delivery channels for fluid release, the portion being less than all the fluid delivery channels.

28. The system of claim 27, wherein the plurality of fluid delivery channels protrude from the expandable structure to penetrate the body tissue of the lumen.

29. The system of claim 27, further comprising a tissue analyzer configured to characterize the body tissue using the plurality of electrodes.

30. The system of claim 29, wherein the fluid delivery channels can be selectively energized to selectively open one or more fluid delivery channels in response to the characterized body tissue.

31. The system of claim 27, wherein the radially expandable structure comprises a balloon and the fluid delivery channels are mounted on a circumference of the balloon.

32. The system of claim 27, wherein the radially expandable structure comprises an expandable basket and the fluid delivery channels are mounted on a circumference of the basket.

33. The system of claim 27, wherein the body tissue of the lumen includes a diseased portion and wherein the controller is configured to selectively energize select electrodes to selectively open one or more fluid delivery channels proximate the diseased portion.

34. The system of claim 27, wherein the controller is configured to selectively energize select electrodes to heat the body tissue in conjunction with the release of the fluid in the lumen.

35. The system of claim 27, wherein the fluid includes any of a lubricant to allow higher temperatures without sticking, an electrically conductive compound to lower the impedance at an electrode, an electrically insulating compound to prevent treatment to tissue that does not need treatment, an electrically conductive compound that is intended to migrate through the endothelial layers of tissue to carry energy to the interstitial layers, or a combination of the above.

36. A catheter system for selective fluid delivery to body tissue being disposed about a lumen, the system comprising:

an elongated flexible catheter body having a proximal end and a distal end;

a radially expandable structure near the distal end of the catheter body;

a plurality of fluid delivery channels oriented to be urged against the body tissue of the lumen when the expandable structure expands, the fluid delivery channels being initially closed; and

a plurality of micro-electromechanical systems (MEMS) coupled to the fluid delivery channels with a controller configured to selectively activate one or more MEMS of the plurality so as to open one or more fluid delivery channels and release a fluid in the lumen.

37. The system of claim 36, wherein the fluid includes any of a lubricant to allow higher temperatures without sticking, an electrically conductive compound to lower the impedance at an electrode, an electrically insulating compound to prevent treatment to tissue that does not need treatment, an electrically conductive compound that is intended to migrate through the endothelial layers of tissue to carry energy to the interstitial layers, or a combination of the above.

38. A method for selective fluid delivery in a lumen, the method comprising:

engaging a body tissue disposed about the lumen with a plurality of fluid delivery channels on a radially expandable structure near a distal end of a catheter when the expandable structure expands;

selectively opening one or more fluid delivery channels such that at least some of the fluid delivery channels remain closed; and

releasing a fluid from the select fluid delivery channels into the lumen,

wherein selectively opening one or more fluid delivery channels comprises selectively energizing electrodes coupled to the select fluid delivery channels to heat the select fluid delivery channels to liquefy a thermal material initially closing the fluid delivery channel.

39. The method of claim 38, wherein the one or more fluid delivery channels comprises a plurality of micro-electromechanical systems (MEMS) coupled to the fluid delivery channels configured to selectively open and/or close the fluid delivery channels.

40. The method of claim 38, further comprising characterizing the body tissue to identify body tissue to be treated and selectively opening or closing one or more fluid delivery channels in response to the characterized body tissue to treat the identified body tissue.

41. The method of claim 38, wherein the plurality of fluid delivery channels are configured to penetrate into the lumen wall.

42. The method of claim 38, wherein the radially expandable structure comprises a balloon and the fluid delivery channels are mounted on a circumference of the balloon.

43. The method of claim 38, wherein the radially expandable structure comprises an expandable basket and the fluid delivery channels are mounted on a circumference of the basket.

44. The method of claim 38, further comprising heating the body tissue in conjunction with releasing the fluid.

45. The method of claim 38, wherein the fluid includes any of a lubricant to allow higher temperatures without sticking, an electrically conductive compound to lower the impedance at an electrode, an electrically insulating compound to prevent treatment to tissue that does not need treatment, an electrically conductive compound that is intended to migrate through the endothelial layers of tissue to carry energy to the interstitial layers, or a combination of the above.