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

• US 6,685,648 B2
• Filed: 04/03/2001
• Issued: 02/03/2004
• Est. Priority Date: 10/11/1996
• Status: Expired due to Term

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: TransVascular, Inc. (Medtronic Plc)
• Inventors: Makower, Joshua, Whitt, Jason B., Colloton, Robert C., Macfarlane, K. Angela, MacAulay, Patrick E., Flaherty, J. Christopher, Evard, Philip C.
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): Thissell, Jeremy
• Application Number:
  US09/826,049
• Publication Number:
  US 20020002349A1
• Time in Patent Office: 1,036 Days
• Field of Search: 604/529, 604/164.11, 604/164.13, 604/20, 604/21, 604/187, 604/198, 604/174, 604/264, 604/272, 604/523, 604/528, 604/103.01, 604/103.02, 604/164.01, 604/164.1, 604/165.04, 604/96.01, 600/462, 600/463, 600/466, 600/467
• US Class Current: 600/464
• 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 method is provided for delivering a drug 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 distal portion of the catheter is percutaneously introduced into a blood vessel, and directed endovascularly to a vessel location adjacent to the selected tissue region. The puncturing element is oriented towards the selected tissue region, and deployed to access the selected tissue region. A drug is delivered with the drug delivery element to the selected tissue region.

Claims

1. A method of delivering a drug 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;

rotating the catherer about its longitudinal axis while using the orientation element to orient the puncturing element towards the selected tissue region;

deploying the puncturing element through a wall of the vessel location to access the selected tissue region; and

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

2. The method of claim 1, wherein the blood vessel comprises a vein.

3. The method of claim 1, wherein the blood vessel comprises a coronary vein, and the selected tissue region comprises myocardial tissue or a coronary artery.

4. The method of claim 1, wherein the orienting step includes the step of imaging the orientation element.

5. The method of claim 4, wherein the orientation element has a predetermined circumferential relationship about a periphery of the catheter with respect to the puncturing element.

6. The method of claim 4, wherein the catheter includes an imaging element adjacent the orientation element, and the imaging step includes the step of operating the imaging element.

7. The method of claim 6, 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.

8. The method of claim 1, 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.

9. The method of claim 1, further comprising the step of mapping the selected tissue region prior to the step of delivering a drug.

10. The method of claim 9, wherein the mapping step includes introducing a radiographic agent into the selected tissue region.

11. The method of claim 1, wherein the delivering step includes the step of deploying the drug delivery element in combination with the puncturing element.

12. The method of claim 11, wherein the drug delivery element comprises an infusion catheter.

13. The method of claim 12, wherein the delivering step includes the step of inflating a porous balloon on the infusion catheter.

14. The method of claim 1, 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.

15. The method of claim 14, wherein the step of delivering the ablation element includes the step of advancing the ablation element over the puncturing element into the tissue region.

16. 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 using the orientation element;

deploying the puncturing element to access the selected tissue region;

advancing a floppy catheter into the selected tissue region via the transvascular catheter; and

removing the transvascular catheter from the body, leaving the floppy catheter in the selected tissue region.

17. The method of claim 16, comprising the additional step of advancing a guide wire into the selected tissue region in conjunction with the puncturing element.

18. The method of claim 17, wherein the step of advancing a floppy catheter comprises tracking the floppy catheter over the guide wire into the selected tissue region.

19. The method of claim 16, comprising the additional step of securing a proximal end of the floppy catheter to a surface location of the patient'"'"'s body.

20. The method of claim 16, comprising the additional step of delivering a drug through the floppy catheter into the selected tissue region.

21. The method of claim 16, wherein the blood vessel comprises a vein.

22. The method of claim 16, wherein the blood vessel comprises a coronary vein, and wherein the selected tissue region comprises myocardial tissue or a coronary artery.

23. A method for delivering a substance to a selected tissue region within a patient'"'"'s body with a catheter having a deployable puncturing element, a drug delivery element, an orientation element, and an imaging clement carried by a distal portion of the catheter, 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;

rotating the catheter about its longitudinal axis while imaging the orientation element with the imaging element to orient the puncturing element towards the selected tissue region;

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

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

24. The method of claim 23, wherein the blood vessel comprises a vein.

25. The method of claim 23, wherein the blood vessel comprises a coronary vein, and tbe selected tissue region comprises myocardial tissue or a coronary artery.

26. The method of claim 23, wherein the puncturing element comprises a needle, and wherein the deploying step includes penetrating through a wall of the blood vessel and entering the tissue region with a distal tip of the needle.

27. The method of claim 23, wherein the delivering step includes the step of deploying the drug delivery element in combination with the puncturing element.

28. The method of claim 27, wherein the drug delivery element comprises an infusion catheter.

29. The method of claim 28, wherein the delivering step includes the step of inflating a porous balloon on the infusion catheter.

30. The method of claim 23, 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.

31. The method of claim 30, wherein the step of delivering the ablation element includes the step of advancing the ablation element over the puncturing element into the tissue region.

32. A method for delivering a substance within a patient'"'"'s heart with a catheter having a 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 into a coronary vein or a coronary artery adjacent to a selected tissue region located beyond a wall of the coronary vein or coronary artery;

orienting the puncturing element towards the selected tissue region using the orientation element;

deploying the puncturing element from the catheter through the wall of the coronary vein or coronary artery to access the selected tissue region; and

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

33. The method of claim 32, wherein the catheter is rotated about its longitudinal axis while using the otientation element to orient the puncturing element towards the selected tissue region.