Intravascular Tissue Disruption

• US 20110257622A1
• Filed: 03/24/2011
• Published: 10/20/2011
• Est. Priority Date: 03/24/2010
• Status: Active Grant

• Current Assignee: Shifamed Holdings, LLC
• Original Assignee: Shifamed Holdings, LLC
• Inventors: Pai, Suresh, Spiridigliozzi, John, Krolik, Jeff, Schaer, Alan, Salahieh, Amr, Saul, Tom
• Granted Patent: US 8,840,601 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61M 2025/0079 Separate user-activated means, e.g. guidewires, guide tubes, balloon catheters or sheaths, for sealing off an orifice, e.g. a lumen or side holes, of a catheter
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• 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 2025/1097 with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
• CPC Class Codes: A61M 2202/0468 non-physiological
• CPC Class Codes: A61M 2202/0484 Alcohol
• CPC Class Codes: A61M 2202/049 Toxic
• CPC Class Codes: A61M 2202/20 Pathogenic agents
• CPC Class Codes: A61M 2210/12 Blood circulatory system
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0071 Multiple separate lumens multiple separate lumens throughout the catheter A61M25/0026
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 25/008 Strength or flexibility characteristics of the catheter tip
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

Disrupting tissue and devices and systems for disrupting tissue. The disclosure describes ways to deliver moieties to a target tissue, where the target tissue in general is not at the point of introduction, in such a way that minimal damage is produced in the tissue at the point of introduction. In some embodiments this is accomplished by jetting fluid at high velocity into the target tissue. The disclosure further describes novel agents deliverable in such systems for use in remodeling tissues. Some of these agents comprise a liquid while others do not. Additionally, although not specifically described in detail much of the disclosure may additionally be used in the delivery of therapeutic drugs.

Claims

1. A method of controlling the delivery of fluid from a medical delivery device, comprising:

a medical device comprising a distal delivery region comprising a plurality of fluid controls; and

selectively regulating the flow of a fluid through the plurality of fluid controls.

2. The method of claim 1 wherein selectively regulating comprises allowing the fluid to be delivered from a first fluid control while minimizing the fluid that is delivered from a second fluid control.

3. The method of claim 1 wherein selectively regulating comprises increasing the flow of fluid from a first fluid control without increasing the flow of fluid through a second fluid control.

4. The method of claim 1 wherein selectively regulating comprises increasing the fluid flow from a first fluid control a first amount and increasing the flow of fluid from a second fluid control a second amount, wherein the first amount is different than the second amount.

5. The method of claim 1 wherein selectively regulating comprising moving a first fluid control from a closed configuration to an open configuration without moving a second fluid control from a closed configuration to an open configuration.

6. The method of claim 5 wherein moving the first control to the open configuration comprises moving a first valve element with a first aperture therein relative to a second valve element with a second aperture therein until the apertures are in alignment.

7. The method of claim 5 wherein moving the first fluid control to the open configuration causes the fluid to flow from the first control at a high velocity, while the fluid flows out of the second fluid control at a low velocity.

8. The method of claim 1 wherein selectively regulating comprises flowing the fluid out of a first fluid control at a high velocity and flowing the fluid out of a second fluid control at a low velocity.

13. The method of claim 1 wherein regulating the volume of fluid released further comprises moving the apertures out of alignment to decrease the flow of fluid out of the fluid control.

14. The method of claim 1 wherein the first control element comprises a first tubular member and the second control element comprises a second tubular member disposed within the first tubular member, and wherein moving the apertures into alignment comprises moving the first tubular member relative to the second tubular member to thereby move the first aperture relative to the second aperture.

15. The method of claim 14 wherein moving the first tubular member relative to the second tubular member comprises at least one of axial movement and rotational movement.

9. A method of regulating the volume of a fluid delivered from a medical device, comprising:

a medical device comprising a distal delivery region comprising a fluid control in communication with a fluid source, wherein the fluid control comprises a first control element with a first aperture therein and a second control element with a second aperture therein;

positioning the distal delivery region near a target location within a patient; and

regulating the volume of fluid released from the fluid control by moving the apertures into alignment to increase the flow of the fluid through the fluid control.

10. The method of claim 9 wherein the regulating step occurs independently of transience generated at a fluid pressure source.

11. The method of claim 9 wherein the fluid source is disposed external to the patient, further comprising maintaining a substantially constant pressure at the fluid source.

12. The method of claim 11 further comprising varying the fluid velocity at the fluid control to regulate the volume of fluid released.

16. A method of periluminal tissue damage, comprising:

positioning a delivery device within a lumen without piercing the lumen wall;

delivering a fluid agent from the delivery device through the lumen wall; and

damaging tissue peripheral to the lumen wall with the fluid agent.

17. The method of claim 16 wherein the lumen wall comprises an intimal layer, and wherein the damaging step comprises damaging nerve cells peripheral to the intimal layer of the lumen wall.

18. The method of claim 17 wherein damaging comprises damaging nerves cells while minimally damaging tissue in the intimal layer of the vessel wall.

19. The method of claim 17 wherein the lumen wall comprises a medial layer, and wherein damaging comprises damaging tissue within the medial layer.

20. The method of claim 17 wherein damaging tissue comprises damaging cells in at least one of a medial layer of the lumen and nerve cells disposed within the adventitial layer.

21. The method of claim 17 wherein a damage cross section increases as the radial distance from the intimal layer increases.

22. The method of claim 16 wherein the delivery device comprises a first fluid control and a second fluid control, wherein delivering comprises delivering the fluid agent from the first fluid control to create a first damage region, and delivering the fluid agent from the second fluid control creates a second damage region, wherein portions of the first and second regions overlap.

23. The method of claim 16 wherein damaging comprises damaging tissue with the direct mechanical interaction of the fluid.

24. The method of claim 16 wherein damaging is caused by chemical interactions with the fluid.

25. The method of claim 24 wherein the fluid is hypotonic.

26. The method of claim 24 wherein the fluid is hypertonic.

27. The method of claim 24 wherein the fluid self-heats on interaction with tissue.

28. The method of claim 24 wherein the fluid has a pH significantly different from the pH of the tissue.

29. The method of claim 24 wherein the fluid comprises material toxic to the tissue.

30. The method of claim 24 wherein the fluid comprises material toxic to a particular tissue.

31. The method of claim 24 wherein the fluid comprises material which becomes toxic on interaction with the tissue.

32. The method of claim 24 wherein the fluid comprises material which is capable of absorbing energy delivered from a source external to the body.

33. The method of claim 16 wherein delivering a fluid agent from the delivery device through the lumen wall comprises delivering the fluid agent towards neural tissue peripheral to an intimal layer of the lumen.

34. The method of claim 16 wherein damaging comprises damaging renal nerve tissue peripheral to a lumen of a renal artery.

35. The method of claim 16 wherein damaging renal nerve tissue reduces hypertension.

36. An apparatus for releasing fluid within a patient'"'"'s body, comprising:

an elongate member comprising

a distal region comprising a plurality of fluid controls,

a lumen extending through the distal region and in fluid communication with the plurality of fluid controls, wherein the lumen is adapted to be in fluid communication with a fluid source,

wherein each of the plurality of fluid controls is adapted to be selectively addressable to regulate the volume of a fluid that is released from the lumen and out the plurality of fluid controls.

37. The apparatus of claim 36 wherein the fluid control has a closed configuration and an open configuration, wherein in the closed configuration a substantially smaller volume of fluid is allowed to be released out of the fluid control than in the open configuration.

38. The apparatus of claim 37 wherein substantially smaller is substantially no fluid.

39. The apparatus of claim 37 wherein in the open configuration the fluid control is adapted to release the fluid at high velocity.

40. The apparatus of claim 36 wherein the distal region comprises a plurality of fluid controls in fluid communication with the lumen, each fluid control has open and closed configurations, and wherein each fluid control is adapted to regulate the volume of fluid that is released from the fluid control when the fluid is delivered at high velocity.

41. The apparatus of claim 40 wherein the plurality of fluid controls are adapted to be individually opened.

42. The apparatus of claim 36 wherein the fluid control is adapted to be in fluid communication with a fluid source maintained at a substantially constant pressure.

43. The apparatus of claim 42 wherein the fluid control controls the volume of fluid that is released from the fluid control while the fluid source is maintained at the substantially constant pressure.

44. An apparatus for controllably releasing fluid within a patient'"'"'s body, comprising:

a first tubular element with a first aperture therein;

a second tubular element with a second aperture therein, wherein the second tubular element is disposed within the first tubular element and movable relative to the first tubular element, wherein the second tubular element has a lumen therethrough adapted to be in fluid communication with a fluid source, and

wherein the apertures have an aligned configuration that allows a fluid to pass from the lumen through the first and second apertures.

45. The apparatus of claim 44 wherein the apertures have an aligned configuration that allows a fluid to pass through the apertures at a high velocity.

46. The apparatus of claim 44 wherein second aperture has a smaller maximum dimension than a maximum dimension of the first aperture.

47. The apparatus of claim 44 further comprising a fluid source maintained at substantially a constant pressure.

48. The apparatus of claim 47 wherein the apertures are adapted to release a fluid therethrough at high velocity.

49. The apparatus of claim 47 wherein the apertures have an aligned configuration that allows fluid to pass therethrough when the fluid source is maintained at a substantially constant first pressure during a first delivery cycle and when the fluid source is maintained at a substantially constant second pressure during a second delivery cycle, wherein the first and second pressure are different.

50. The apparatus of claim 44 wherein the first tubular element has a deformed treatment configuration wherein at least a portion of the first tubular element is adapted to engage a lumen wall in which it is positioned.

51. The apparatus of claim 50 wherein the deformed treatment configuration is substantially spiral-shaped.

52. The apparatus of claim 50 further comprising an expandable element that is adapted to deform the first tubular element into contact with the lumen wall.

53. The apparatus of claim 52 wherein the expandable element comprises a balloon.

54. The apparatus of claim 52 wherein the expandable element is moveable relative to the first tubular element to cause the first tubular element to be deformed into the treatment configuration.

55. The apparatus of claim 44 further comprising a piercing element in fluid communication with the first aperture and extending from the first aperture, wherein the piercing element is adapted to pierce tissue and allow for the fluid to flow from the aperture and out of the piercing element.

56. The apparatus of claim 44 wherein the apertures have a non-aligned configuration that is adapted to allow fluid to flow therethrough at a low velocity.

57. An apparatus for controllably releasing fluid within a patient'"'"'s body, comprising:

an elongate member comprising a distal end, a proximal end, and a therapy portion in between the ends;

the therapy portion comprises a plurality of expandable elongate elements, each with a delivery configuration and a treatment configuration,

wherein each of the plurality of expandable elongate elements comprises a fluid control, and in the delivery configuration the control faces a first direction and in the treatment configuration the control faces a second direction different than first direction.

58. The apparatus of claim 57 wherein the second direction is generally orthogonal to a longitudinal axis of the elongate member.

59. The apparatus of claim 57 wherein the first direction is substantially parallel to a longitudinal axis of the elongate member.

60. The apparatus of claim 57 wherein the expandable elongate elements are tubular elements, and wherein the fluid controls are provided by removing sections from the tubular elements.

61. The apparatus of claim 57 wherein the fluid controls are proximal to distal ends of the elongate elements.

62. The apparatus of claim 57 wherein the expandable elongate elements are adapted to preferentially bend in the region of the fluid ports in the treatment configurations.

63. The apparatus of claim 57 wherein the expandable elongate elements are self-expanding.

64. The apparatus of claim 57 wherein the expandable elongate elements are actuatable.