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

• US 6,283,951 B1
• Filed: 03/25/1998
• Issued: 09/04/2001
• 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: Flaherty, J. Christopher, Makower, Joshua, Whitt, Jason B., Evard, Philip C., Colloton, Robert C., Macfarlane, K. Angela, MacAulay, Patrick E.
• Primary Examiner(s): Nguyen, Anhtuan T.
• Assistant Examiner(s): Thissell, Jeremy
• Application Number:
  US09/048,147
• Time in Patent Office: 1,259 Days
• Field of Search: 604/20, 604/21, 604/187, 604/198, 604/174, 604/264, 604/272, 604/523, 604/528, 604/529, 604/103.01, 604/103.02, 604/164.01, 604/164.1, 604/164.11, 604/164.13, 604/165.04, 604/96.01
• US Class Current: 604/529
• 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 for delivering a drug to a tissue region from a blood vessel, such as a coronary vein, includes a catheter having a distal portion with puncturing, orientation, drug delivery, and imaging elements. The puncturing element is deployable for penetrating the vessel wall to access the tissue region. The orientation element, e.g. a “cage” including a plurality of struts and/or a radiopaque marker, has a predetermined relationship with the puncturing element, the imaging element detecting the location of the orientation element with respect to the tissue region to orient the puncturing element. The catheter is percutaneously introducing into the vessel, the puncturing element is oriented towards the tissue region, the puncturing element is deployed to access the tissue region, and the drug is delivered to the tissue region. An ablation device may also be deployed to create a cavity in the tissue region for receiving the drug therein, or an indwelling catheter may be advanced into and left in the tissue region. An implantable reservoir device is also disclosed, including an enclosed membrane on an expandable frame that defines a reservoir and includes a porous region. The reservoir device 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. Alternatively, a pair of expandable endovascular blockers 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 substance towards a target 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 rotational 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;

a drug delivery element on the distal portion for delivering a substance towards the target region beyond a wall of the blood vessel, the drug delivery element being aligned with the peripheral orientation of the orientation element; and

an imaging element adjacent the orientation element for detecting the rotational orientation of the orientation element with respect to the target region.

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 1, wherein the orientation element has an asymmetric configuration aligned with the drug delivery element for providing the peripheral orientation about the longitudinal axis.

6. The system of claim 1, wherein the orientation element comprises a cage structure including a plurality of struts extending axially along the distal portion.

7. The system of claim 1, wherein the orientation element comprises a first strut at a location in direct axial alignment with the drug deliver element.

8. The system of claim 7, wherein the orientation element further comprises a pair of struts opposite the first strut.

9. A system for delivering a substance to a target 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 target region beyond the wall of the blood vessel;

a drug delivery element on the distal portion for delivering a substance to the target region;

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

an imaging element adjacent the orientation element for detecting the location of the orientation element with respect to the target region.

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

11. The system of claim 9, wherein the catheter includes a lumen extending from the proximal portion to the distal portion for receiving the imaging element therein.

12. The system of claim 9, 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.

13. The system of claim 9, 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.

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

15. The system of claim 14, 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.

16. The system of claim 9, wherein the drug delivery element comprises an indwelling catheter deployable in combination with the puncturing element to the tissue region.

17. The system of claim 9, wherein the puncturing element comprises a guide wire, and wherein the drug delivery element is deployable over the guide wire.

18. The system of claim 17, wherein the drug delivery element comprises an infusion catheter.

19. The system of claim 17, wherein the drug delivery element comprises a perfusion balloon.

20. The system of claim 17, wherein the guide wire includes an anchoring tip for fixing the guide wire in the tissue region.

21. The system of claim 17, wherein the drug delivery element includes an anchoring tip for fixing the drug delivery element in the tissue region.

22. The system of claim 9, 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.

23. The system of claim 22, wherein the second electrode is attachable to a surface region of the patient being treated.

24. 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;

a rotational 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;

a drug delivery assembly deployable from the distal portion and aligned with the peripheral orientation of the orientation element, the drug delivery assembly including a puncturing element for penetrating a wall of a blood vessel to access a tissue region beyond the wall of the blood vessel, and including a drug element comprising a lumen for delivering a drug to the tissue region; and

an imaging element adjacent the orientation element for detecting the relationship of the orientation element with respect to the tissue region.

25. The system of claim 24, wherein the drug delivery assembly further comprises means for creating a cavity within the target region.

26. The system of claim 25, wherein the means for creating a cavity comprises a balloon.

27. The system of claim 26, wherein the drug delivery element comprises a drug delivery catheter having the balloon on a distal portion thereof.

28. The system of claim 27, wherein the balloon comprises a porous region in communication with the lumen.

29. The system of claim 24, wherein the puncturing element comprises a needle or a guide wire deployable from the distal portion of the catheter.

30. The system of claim 29, wherein the needle or guidewire is deployable substantially radially from the distal portion of the catheter.

31. The system of claim 30, further comprising a control mechanism on the proximal portion of the catheter linked to the needle or guide wire for deploying the needle or guidewire a precise distance radially from the distal portion.

32. The system of claim 24, wherein the catheter includes a deflecting element for directing the puncturing element substantially transversely with respect to the longitudinal axis when the puncturing element is deployed.

33. The system of claim 24, wherein the imaging element comprises an ultrasound transducer.

34. The system of claim 24, wherein the catheter includes a lumen extending from the proximal portion to the distal portion for receiving the imaging element therein.

35. The system of claim 24, wherein the drug delivery element comprises an indwelling catheter deployable in combination with the puncturing element to the target region.

36. The system of claim 24, wherein the drug delivery element comprises an infusion catheter.

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

38. The system of claim 24, 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 substance from the drug delivery element is ionophoretically directed from the drug delivery element towards the second electrode.

39. The system of claim 24, wherein the imaging element comprises an ultrasound transducer.

40. The system of claim 39, wherein the ultrasound transducer is configured for imaging in an imaging plane substantially normal to the longitudinal axis of the catheter.

41. The system of claim 39, wherein the ultrasound transducer is insertable into a lumen of the catheter until it is disposed adjacent the orientation element.