Systems and methods for delivering drugs to selected locations within the body

• US 20040133154A1
• Filed: 12/16/2003
• Published: 07/08/2004
• Est. Priority Date: 10/11/1996
• Status: Active Grant

• Current Assignee: TransVascular, Inc. (Medtronic Plc)
• Original Assignee: TransVascular, Inc. (Medtronic Plc)
• Inventors: Flaherty, J. Christopher, Makower, Joshua, Whitt, Jason B., Evard, Philip C., Colloton, Robert C., MacFarlane, K. Angela, MacAulay, Patrick E.
• Granted Patent: US 7,094,230 B2
• Time in Patent Office: Days
• US Class Current: 604/93.01
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/1477 Needle-like probes
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/00504 Tissue welding
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61B 2017/12127 Double occlusion, e.g. for creating blood-free anastomosis site
• CPC Class Codes: A61B 2017/22077 : with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/306 : holding by means of suction
• CPC Class Codes: A61B 2017/347 : Locking means, e.g. for locking instrument in cannula
• CPC Class Codes: A61B 2018/00392 : Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 8/12 : in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 90/40 : Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
• CPC Class Codes: A61F 2/2493 : Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61F 2002/30079 : magnetic
• CPC Class Codes: A61F 2210/009 : magnetic
• CPC Class Codes: A61M 2025/0037 : characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0076 : Unidirectional valves
• CPC Class Codes: A61M 2025/0086 : the needles having bent tips, i.e. the needle distal tips are angled in relation to the longitudinal axis of the catheter
• CPC Class Codes: A61M 2025/0087 : Multiple injection needles protruding laterally from the distal tip
• CPC Class Codes: A61M 2025/009 : the needle having a bent tip, i.e. the needle distal tip is angled in relation to the longitudinal axis of the catheter
• CPC Class Codes: A61M 2025/0096 : being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• 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 25/0069 : Tip not integral with tube
• CPC Class Codes: A61M 25/007 : Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0084 : being one or more injection needles
• CPC Class Codes: A61M 25/0108 : using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 39/0208 : Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 39/04 : having pierceable self-sealing members
• CPC Class Codes: A61M 5/007 : for contrast media
• CPC Class Codes: A61M 5/46 : having means for controlling depth of insertion

Abstract

A transvascular system (10) for delivering a drug to a tissue region from a blood vessel, such as a coronary vein, includes a catheter (12) having a distal portion (26) with puncturing (14), orientation (16), drug delivery (62), and imaging elements (18). The puncturing element (14) is deployable for penetrating the vessel wall to access the tissue region. The orientation element (16), e.g. a “cage” including a plurality of struts (38)(40) and/or a radiopaque marker, has a predetermined relationship with the puncturing element (14), the imaging element (18) detecting the location of the orientation element (16) with respect to the tissue region to orient the puncturing element. The catheter (12) is percutaneously introducing into the vessel, the puncturing element (14) is oriented towards the tissue region, the puncturing element (14) is deployed to access the tissue region, and the drug is delivered to the tissue region. An ablation device (230) may also be deployed to create a cavity in the tissue region for receiving the drug therein, or an indwelling catheter (214) may be advanced into and left in the tissue region. An implantable reservoir device (400) is also disclosed, including an enclosed membrane (408) on an expandable frame (402) that defines a reservoir (410) and includes a porous region (418). The reservoir device (400) may be deployed and expanded within a blood vessel, and may be filled in situ or prefilled with a drug that passes through the porous region (418). Alternatively, a pair of expandable endovascular blockers (500) may be used to isolate a section of a blood vessel which may be filled with a drug that may be absorbed by the surrounding tissue.

Claims

1. A system for delivering a drug towards a tissue region within a patient'"'"'s body, the system comprising:

a catheter having a proximal portion and a distal portion adapted for insertion into a blood vessel, and defining a periphery and a longitudinal axis;

an orientation element on the distal portion in a predetermined circumferential relationship with the periphery of the catheter for providing a peripheral orientation of the distal portion about the longitudinal axis; and

a drug delivery element on the distal portion for delivering a drug in a predetermined direction with respect to the longitudinal axis, the drug delivery element being aligned with the peripheral orientation of the orientation element.

2. The system of claim 1, wherein the drug delivery element comprises a needle deployable from the distal portion.

3. The system of claim 2, wherein the needle is deployable substantially radially from the distal portion.

4. The system of claim 3, further comprising a control mechanism on the proximal portion of the catheter linked to the needle for deploying the needle a precise distance radially from the distal portion, whereby the needle may be precisely deployed to a selected region remote from the catheter within a reference frame including a peripheral component and a radial component.

5. The system of claim 3, further comprising an imaging element adjacent the orientation element for detecting the relationship of the orientation element with respect to the selected region, thereby providing the peripheral component and the radial component of the selected region within the reference frame.

6. The system of claim 1, wherein the drug delivery element comprises an osmotic surface on a portion of the periphery aligned with the peripheral orientation of the orientation element.

7. A system for delivering a drug to a tissue region within a patient'"'"'s body, the system comprising:

a catheter having a proximal portion and a distal portion adapted for insertion into a blood vessel, and defining a periphery and a longitudinal axis;

a puncturing element deployable from the distal portion in a predetermined circumferential relationship with the periphery of the catheter, and including a distal tip adapted to penetrate a wall of a blood vessel to access a tissue region beyond the wall of the blood vessel;

a drug delivery element on the distal portion for delivering a drug to the tissue region; and

an orientation element on the distal portion in a predetermined relationship with the periphery of the catheter and the puncturing element.

8. The system of claim 7, further comprising an imaging element adjacent the orientation element for detecting the location of the orientation element with respect to the tissue region.

9. The system of claim 8, wherein the imaging element comprises an ultrasound transducer.

10. The system of claim 8, wherein the catheter includes a lumen extending from the proximal portion to the distal portion for receiving the imaging element therein.

11. The system of claim 7, further comprising:

a handle on the proximal portion; and

a control mechanism on the handle linked to the puncturing element for precisely advancing the puncturing element from the distal portion.

12. The system of claim 7, further comprising a peripheral opening at a predetermined circumferential location on the periphery of the distal portion through which the puncturing element may be deployed.

13. The system of claim 12, wherein the catheter includes a needle lumen communicating with the peripheral opening for receiving the puncturing element therethrough.

14. The system of claim 13, wherein the needle lumen includes a deflecting element adapted to direct the distal tip substantially transversely with respect to the longitudinal axis when the puncturing element is deployed.

15. The system of claim 7, wherein the puncturing element comprises a needle and wherein the drug delivery element comprises a lumen in the needle.

16. The system of claim 15, wherein the needle includes an array of outlet ports for providing a predetermined flow pattern of fluid into the tissue region accessed by the needle.

17. The system of claim 15, wherein the needle includes a plurality of lumens extending therethrough for independently introducing a plurality of drugs.

18. The system of claim 7, wherein at least a portion of the puncturing element comprises a conductive material electrically coupled to a proximal end of the puncturing element for coupling the puncturing element to a source of electric current.

19. The system of claim 7, wherein the puncturing element comprises a plurality of needles deployable from predetermined locations on the distal portion to provide a selected trajectory pattern for the drug delivery element.

20. The system of claim 7, further comprising an implantable port assembly including a hub that is attachable to the drug delivery element, and a penetrable seal providing a fluid-tight seal with the drug delivery element, the implantable port assembly being implantable in the patient'"'"'s body for providing long term access to the tissue region.

21. The system of claim 7, wherein the drug delivery element comprises an indwelling catheter deployable in combination with the puncturing element to the tissue region.

22. The system of claim 7, wherein the puncturing element comprises a guide wire, and wherein the drug delivery element is deployable over the guide wire.

23. The system of claim 22, wherein the drug delivery element comprises an infusion catheter.

24. The system of claim 22, wherein the drug delivery element comprises a perfusion balloon.

25. The system of claim 22, wherein the guide wire includes an anchoring tip for fixing the guide wire in the tissue region.

26. The system of claim 22, wherein the drug delivery element includes an anchoring tip for fixing the drug delivery element in the tissue region.

27. The system of claim 7, wherein the drug delivery element includes a first electrode thereon adapted to be electrically coupled to a second electrode, whereby when direct current is directed between the first and second electrodes, a drug from the drug delivery element is ionophoretically directed from the drug delivery element towards the second electrode.

28. The system of claim 27, wherein the second electrode is attachable to a surface region of the patient being treated.

29. The system of claim 7, wherein the drug delivery element comprises an osmotic surface on the distal portion of the catheter.

30. The system of claim 7, further comprising a feedback sensor on the drug delivery element or the puncturing element.

31. The system of claim 30, wherein the feedback sensor comprises an element for detecting a physiological condition at the tissue region.

32. The system of claim 30, wherein the feedback sensor comprises an EKG lead.

33. A system for delivering a drug to a tissue region within a patient'"'"'s body, the system comprising:

a catheter having a proximal portion and a distal portion adapted for insertion into a blood vessel, and defining a periphery and a longitudinal axis;

a needle deployable from the distal portion having a drug delivery lumen therein for delivering drugs therethrough;

an orientation element on the distal portion in a predetermined relationship with the needle; and

an imaging element adjacent the orientation element for detecting the location of the orientation element with respect to a tissue region surrounding the distal portion.

34. The system of claim 33, wherein

the catheter includes a needle lumen extending from the proximal portion to a peripheral opening at a predetermined circumferential location on the periphery of the distal portion through which the needle may be deployed, and

the orientation element has an asymmetric configuration aligned with the peripheral opening on the periphery.

35. The system of claim 34, wherein the orientation element comprises a plurality of struts extending axially along the distal portion.

36. The system of claim 34, wherein one of the plurality of struts is provided at a location in direct axial alignment with the peripheral opening.

37. The system of claim 34, wherein the orientation element comprises a radiopaque marker.

38. The system of claim 37, wherein the radiopaque marker comprises a pair of markers disposed opposite one another on the periphery.

39. A system for creating a reservoir in a tissue region within a patient'"'"'s body for receiving a drug therein, the system comprising:

a catheter having a proximal portion and a distal portion adapted for insertion into a blood vessel, and defining a periphery and a longitudinal axis;

a guide wire assembly deployable from the distal portion in a predetermined circumferential relationship with the periphery of the catheter;

an orientation element on the distal portion in a predetermined relationship with the guide wire assembly, the orientation element being detectable by an imaging element for detecting the location of the orientation element with respect to an extravascular tissue region surrounding the distal portion; and

a tissue ablation device deployable in combination with the guide wire assembly for forming a cavity in the extravascular tissue region.

40. The system of claim 39, further comprising an imaging element adjacent the orientation element for detecting the location of the orientation element with respect to an extravascular tissue region surrounding the distal portion.

41. A reservoir device for providing sustained delivery of a drug within the cardiovascular system of a patient, comprising:

an elongate frame adapted to expand between a collapsed condition for insertion into a blood vessel and an enlarged condition for engaging a wall of the blood vessel, the frame defining a longitudinal axis and a periphery; and

a flexible membrane attached to the frame and defining a reservoir therein, the membrane including a porous region.

42. The device of claim 41, wherein the porous region of the membrane is disposed along the periphery of the frame.

43. The device of claim 41, wherein the frame is biased towards the enlarged condition.

44. The device of claim 41, wherein the porous region comprises a semi-permeable material.

45. The device of claim 41, further comprising a drug within the reservoir adapted to pass through the porous region of the membrane.

46. The device of claim 45, further comprising an anti-coagulant compound within the reservoir.

47. The device of claim 41, wherein an end region of the membrane is penetrable by an injection device to facilitate in situ filling of the reservoir.

48. The device of claim 41, further comprising a septum dividing the reservoir into first and second reservoir regions.

49. The device of claim 48, wherein the membrane includes an osmotic region communicating with the first reservoir region.

50. The device of claim 49, wherein the porous region of the membrane communicates with the second reservoir region.

51. A method of delivering a selected to a selected tissue region within a patient'"'"'s body with a catheter having a deployable puncturing element, a drug delivery element and an orientation element on a distal portion thereof, the method comprising:

percutaneously introducing the distal portion of the catheter into a blood vessel;

directing the distal portion endovascularly to a vessel location adjacent to the selected tissue region;

orienting the puncturing element towards the selected tissue region;

deploying the puncturing element to access the selected tissue region; and

delivering a drug with the drug delivery element to the selected tissue region.

52. The method of claim 51, wherein the blood vessel comprises a vein.

53. The method of claim 51, wherein the blood vessel comprises a coronary vein, and the selected tissue region comprises myocardial tissue or a coronary artery.

54. The method of claim 51, wherein the orienting step includes the step of imaging the orientation element.

55. The method of claim 54, wherein the orientation element has a predetermined circumferential relationship about a periphery of the catheter with respect to the puncturing element.

56. The method of claim 54, wherein the catheter includes an imaging element adjacent the orientation element, and the imaging step includes the step of operating the imaging element.

57. The method of claim 56, wherein the imaging element comprises an ultrasound transducer, and the step of operating the imaging element includes the step of obtaining an image slice including the selected tissue region along a plane substantially normal to a longitudinal axis of the catheter.

58. The method of claim 51, wherein the puncturing element comprises a needle, and wherein the deploying step includes penetrating a wall of the blood vessel and entering the tissue region with a distal tip of the needle.

59. The method of claim 51, further comprising the step of mapping the selected tissue region prior to the step of delivering a drug.

60. The method of claim 59, wherein the mapping step includes introducing a radiographic agent into the selected tissue region.

61. The method of claim 51, wherein the delivering step includes the step of deploying the drug delivery element in combination with the puncturing element.

62. The method of claim 61, wherein the drug delivery element comprises an infusion catheter.

63. The method of claim 62, wherein the delivering step includes the step of inflating a porous balloon on the infusion catheter.

64. The method of claim 51, further comprising the steps of:

delivering an ablation element to the tissue region; and

activating the ablation element to create a drug reservoir within the tissue region.

65. The method of claim 64, wherein the step of delivering the ablation element includes the step of advancing the ablation element over the puncturing element into the tissue region.

66. A method of creating a fluid reservoir within an extravascular tissue region for sustained delivery of a drug using a catheter having a guide wire and an orientation element on a distal portion thereof, the method comprising the steps of:

percutaneously introducing the distal portion of the catheter into a blood vessel;

directing the distal portion endovascularly to a vessel location adjacent to the tissue region;

orienting the guide wire towards the tissue region;

deploying the guide wire into the tissue region; and

forming a drug reservoir within the tissue region.

67. The method of claim 66, wherein the blood vessel comprises a vein.

68. The method of claim 66, wherein the blood vessel comprises a coronary vein and the extravascular tissue region comprises myocardial tissue.

69. The method of claim 66, further comprising the step of introducing a drug into the drug reservoir.

70. The method of claim 66, wherein the step of forming a drug reservoir includes the steps of delivering an ablation element into the tissue region, and activating the ablation element to create the drug reservoir.

71. The method of claim 66, further comprising the step of introducing a sealant into the drug reservoir to seal the drug reservoir from the vessel location.

72. The method of claim 66, wherein the step of forming a drug reservoir includes the step of removing a portion of the tissue region.

73. A method for creating a drug reservoir within a blood vessel for delivering a drug to a tissue region adjacent the blood vessel, the method comprising the steps of:

advancing a first endovascular blocker in a collapsed condition along the blood vessel to a location adjacent the tissue region;

expanding the first endovascular blocker to an enlarged condition, thereby sealing the blood vessel at the location from fluid flow along the blood vessel;

advancing a second endovascular blocker in a collapsed condition along the blood vessel to the location;

expanding the second endovascular blocker to an enlarged condition, thereby further sealing the blood vessel at the location from fluid flow along the blood vessel; and

introducing a drug into the blood vessel adjacent the first endovascular blocker.

74. The method of claim 73, wherein the step of expanding the second endovascular blocker includes the step of deploying the second endovascular blocker adjacent to the first endovascular blocker, thereby defining a drug reservoir within the blood vessel between the first and second endovascular blockers.

75. The method of claim 73, wherein the introducing step includes the step of introducing the drug into the drug reservoir.

76. The method of claim 75, wherein the blood vessel comprises a vein.

77. The method of claim 75, wherein the blood vessel comprises a coronary vein, and wherein the tissue region comprises myocardial tissue or a coronary artery.

78. A method of providing access to a selected tissue region within a patient'"'"'s body from a blood vessel using a transvascular catheter having a deployable puncturing element, and an orientation element on a distal portion thereof, the method comprising:

percutaneously introducing the distal portion of the transvascular catheter into a blood vessel;

directing the distal portion endovascularly to a vessel location adjacent to the selected tissue region;

orienting the puncturing element towards the selected tissue region;

deploying the puncturing element to access the selected tissue region;

advancing a floppy catheter into the selected tissue region; and

removing the transvascular catheter from the body.

79. The method of claim 78, comprising the additional step of advancing a guide wire into the selected tissue region.

80. The method of claim 79, wherein the step of advancing a floppy catheter comprises tracking the floppy catheter over the guide wire into the selected tissue region.

81. The method of claim 78, comprising the additional step of securing a proximal end of the floppy catheter to a surface location of the patient'"'"'s body.

82. The method of claim 78, comprising the additional step of delivering a drug through the floppy catheter into the selected tissue region.

83. The method of claim 78, wherein the blood vessel comprises a vein.

84. The method of claim 78, wherein the blood vessel comprises a coronary vein, and wherein the selected tissue region comprises myocardial tissue or a coronary artery.