Directional Delivery of Energy and Bioactives

• US 20110130708A1
• Filed: 05/11/2010
• Published: 06/02/2011
• Est. Priority Date: 05/13/2009
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Vessix Vascular, Inc. (Boston Scientific Corporation)
• Inventors: Schreiber, Ronda, Stone, Corbett, Gustus, Rolfe T., Perry, Mike, Hoey, Michael F., Conn, Brian D.
• Granted Patent: US 8,551,096 B2
• Time in Patent Office: Days
• 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 18/1815 using microwaves
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 Balloons

Abstract

Systems and methods are disclosed for the treatment of a target tissue by directionally delivering energy and/or bioactive materials to achieve a therapeutic effect. A balloon catheter system having a balloon portion and a plurality of electrodes may be energized to selectively deliver energy, bioactive materials, or a combination thereof to target tissue including tissues disposed about a lumen. The tissue may be targeted by applying energy, making tissue impedance analysis, and further selectively energizing electrodes through the use of an energy source with a controller.

Claims

1. A system for the treatment of a target tissue by directionally delivering energy and/or bioactive material, 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 surface on the balloon;

a thermally changeable coating having a releasable bioactive material and coupled to the balloon, the thermally changeable coating being oriented to be urged against the target tissue when the balloon expands; and

an energy source operatively coupled to the catheter to energize the energy delivery surface so as to heat the thermally changeable coating and release the bioactive material to the target tissue.

2. The system of claim 1, wherein the energy delivery surface comprises a plurality of spaced electrodes disposed about the expandable balloon, the energy source operatively coupled to the plurality of electrodes so as to selectively energize electrode pairs to heat portions of the thermally changeable coating between the electrode pairs to release the bioactive material to the target tissue.

3. The system of claim 2, wherein the electrodes are coated with an insulating material.

4. The system of claim 1, wherein the balloon is encapsulated by a selectively permeable membrane overlaid by a plurality of circumferentially spaced electrodes.

5. The system of claim 4, wherein the balloon is configured to receive inflation media comprising bioactive material.

6. The system of claim 1, further comprising a tissue analyzer configured to characterize the body tissue.

7. The system of claim 6, wherein the electrode delivery portion is energized to heat the thermally changeable coating to release the bioactive material in response to the characterized body tissue.

8. The system of claim 1, wherein the electrode delivery portion is energized to heat the body tissue before, during and/or after the delivery of the bioactive material.

9. The system of claim 1, wherein the thermally changeable coating includes more than one releasable bioactive material, wherein each material may have a different phase change temperature.

10. The system of claim 1, wherein the bioactive material is selected from at least one of, an antiproliferative, an antithrombin, an immunosuppressant, a lipid, an anti-lipid, a liposome, an anti-inflamatory, an antineoplastic, an antiplatelet, an angiogenic agent, an anti-angiogentic agent, a vitamin, an aptamer, an antimitotic, a metalloproteinase inhibitor, a NO donor, an estradiol, an anti-sclerosing agent, a vasoactive, a growth factor, a beta blocker, an AZ blocker, a hormone, a statin, an antioxidant, a membrane stabilizing agent, a calcium antagonist, a retinoid, a peptide, a lipoprotein, a polypeptide, a polynucleotide encoding polypeptides, a protein, a protein drug, an enzyme, a genetic material, a cell, a chemical solvent, an energy-activated agent, an anti-lymphocyte, an anti-macrophage substance or a combination of any of the above.

11. The system of claim 1, wherein the bioactive material is attached to a portion of a liposome.

12. The system of claim 1, where in the thermally changeable coating is selected from at least one of, polylactic acid, polyglycolic acid, polyvinyl acetate, polyvinyl propylene, hydroxypropyl methylcellulose, methacrylate or a combination of any of the above

13. The system of claim 1, wherein the energy source is a RF energy source and the delivery portion is configured to transmit RF energy to release and/or activate at least one bioactive material.

14. The system of claim 1, wherein the energy source is a light energy source and the delivery portion is configured to transmit light energy to release and/or activate at least one bioactive material.

15. A method for the selective delivery of a releasable bioactive material, the method comprising:

engaging a body tissue disposed about a lumen with a thermally changeable coating by radially expanding a balloon of a catheter, the thermally changeable coating disposed on the balloon;

energizing a surface on the balloon to heat the thermally changeable coating; and

releasing the bioactive material from the thermally changeable coating into the body tissue in response to the heating.

16. The method of claim 15, wherein the delivery portion comprises a plurality of electrodes disposed about the expandable balloon and select electrode pairs are energized to heat and liquefy portions of the thermally changeable coating between the electrode pairs.

17. The method of claim 15, 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.

18. The method of claim 15, further comprising characterizing the body tissue to identify body tissue to be treated and selectively heating portions of the thermally changeable coating to release the bioactive material in response to the characterized body tissue to treat the identified body tissue.

19. The method of claim 15, further comprising heating the body tissue before, during and/or after the delivery of the bioactive material.

20. The method of claim 15, wherein the bioactive material is selected from at least one of a therapeutic fluid, an anesthetic drug, a therapeutic drug, a small molecule, a gene therapeutic compound, an anti-thrombolytic agent, 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.

21. The method of claim 15, wherein the delivery portion is energized with RF energy to release and/or activate at least one bioactive material.

22. The method of claim 15, wherein the delivery portion is energized with laser energy to release and/or activate at least one bioactive material.

23. The method of claim 15, wherein the delivery portion is energized with ultrasound energy to release and/or activate at least one bioactive material.

24. The method of claim 15, wherein the delivery portion is energized with microwave energy to release and/or activate at least one bioactive material.

25. A catheter system for bioactive material 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 surface proximate the balloon for transmission of energy;

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

an energy source operatively coupled to a controller to selectively energize the delivery portion so as to heat the biomolecules to release the bioactive material to the body tissue.

29. (canceled)

31-40. -40. (canceled)

42-46. -46. (canceled)

47. A method of delivering a bioactive material in a lumen, the method comprising:

engaging a body tissue disposed about the lumen with a plurality of biomolecules having a thermally releasable drug portion and an inert portion covalently bound to the balloon near a distal end of a catheter when the expandable balloon expands;

energizing an electrode delivery portion of the catheter proximate the balloon to heat the biomolecules; and

releasing the drug portion from the biomolecules into the body tissue in response to the heating of the biomolecules.

48. 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;

a plurality of fluid delivery channels expandable with the expandable structure, the fluid delivery channels being initially blocked with a thermally changeable material; and

an energy source operatively coupled to the fluid delivery channels so as to heat and liquefy the thermally changeable material to open one or more of the fluid delivery channels for fluid release.

49. The system of claim 48, wherein the plurality of fluid delivery channels protrude from the expandable structure to penetrate the body tissue of the lumen.

50. The system of claim 48, further comprising a tissue analyzer configured to characterize the body tissue.

51. The system of claim 48, 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.

52. The system of claim 48, wherein the radially expandable structure comprises a balloon and the fluid delivery channels are mounted on a circumference of the balloon.

53. The system of claim 48, wherein the radially expandable structure comprises an expandable basket and the fluid delivery channels are mounted on a circumference of the basket.

54. The system of claim 48, wherein the body tissue of the lumen includes a diseased portion and select electrodes are energized to selectively open one or more fluid delivery channels proximate the diseased portion.

55. The system of claim 48, wherein select electrodes are energized to heat the body tissue in conjunction with the release of the fluid in the lumen.

56. The system of claim 48, wherein the fluid is selected from at least one of, ceramide, suramin, rapamycin, paclitaxel, sirolimus, zotarolimus, everolimus, a therapeutic fluid, an anesthetic drug, a therapeutic drug, a small molecule, a gene therapeutic compound, an anti-thrombolytic agent, 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.

57. 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; and

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

58. 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 by a radially expanding a structure within the lumen;

selectively opening one or more of the fluid delivery channels; and

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

59. The method of claim 58, wherein selectively opening one or more fluid delivery channels comprises a plurality of micro-electromechanical systems (MEMS) coupled to the fluid delivery channels to selectively open and/or close the fluid delivery channels.

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

an elongate catheter having a proximal end and a distal end with an axis therebetween;

a radially expandable porous balloon having an inner surface and an outer surface;

wherein the balloon is positioned near the distal end of the catheter with an energy delivery surface proximate the balloon for transmission of energy;

a selectively porous membrane having an inner surface and an outer surface;

wherein the membrane is overlaid on the balloon;

an inflation media for inflating the balloon;

wherein the media includes a drug such that the drug is introduced between the outer surface of the porous balloon and the inner surface of the membrane when the balloon is inflated with the inflation media; and

an energy source coupled to the proximal end of the catheter to deliver energy to the energy delivery surface while the balloon is expanded within the lumen so as to deliver the drug from the outer surface of the balloon through the membrane to the body tissue

61. A catheter system for selective drug 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 balloon near the distal end of the catheter body having an inner and outer surface, the outer surface comprised of a biocompatible matrix;

a coating of a soluble bioactive material on the matrix, the material oriented toward a moist surface of the tissue to allow the moisture to solubilize the bioactive material and force it from the matrix when the balloon is expanded against the tissue and a fluid pressure overcomes an osmotic pressure.

62. A system for the treatment of a target tissue by directionally delivering energy and/or bioactive material, 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 surface on the balloon;

a changeable coating having a releasable bioactive material and coupled to the balloon, the changeable coating being oriented to be urged against the target tissue when the balloon expands; and

an energy source operatively coupled to the catheter to energize the energy delivery surface so as to change the changeable coating and release the bioactive material to the target tissue.