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

• US 7,670,329 B2
• Filed: 08/15/2006
• Issued: 03/02/2010
• Est. Priority Date: 10/13/1995
• Status: Expired due to Fees

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Colloton, Robert, MacFarlane, K. Angela, Flaherty, Christopher, Makower, Joshua, Macaulay, Patrick, Whitt, Jason, Evard, Philip
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): Anderson; Michael J
• Application Number:
  US11/464,644
• Publication Number:
  US 20070021730A1
• Time in Patent Office: 1,295 Days
• Field of Search: 604/506, 604/507, 604/500, 604/164.01, 604/164.11, 604/164.13, 604/529
• US Class Current: 604/506
• 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 or fluid reservoir in the tissue region for receiving the drug therein, or an indwelling catheter (214) may be advanced into and left in the tissue region.

Claims

1. A method for delivering a non-ablative substance to a location within a tissue region using a catheter system having a catheter body, a puncturing element that advances laterally from the catheter body, a substance delivery element, a feedback element, cavity forming apparatus useable to from a cavity within the tissue region and an orientation element, the method comprising the steps of:

positioning the catheter within the lumen of a blood vessel;

using the orientation element to adjust the rotational orientation of the catheter within the blood vessel, if necessary, to orient the puncturing element toward the tissue region;

advancing the puncturing element laterally from the catheter body towards the tissue region;

using the feedback element determine a physiological condition within the tissue region;

using the cavity forming apparatus to form a cavity within the tissue region; and

using the substance delivery element to deliver a quantity of the substance into the previously formed cavity to thereby create a substance reservoir.

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 tissue region comprises a location within cardiac tissue.

4. The method of claim 1, wherein the substance delivery element comprises an indwelling delivery catheter that may remain in place to deliver the substance into the cavity after the catheter body, puncturing element, substance delivery element and cavity forming apparatus have been removed.

5. The method of claim 1, wherein the step of using the cavity forming apparatus to form a cavity within the tissue region includes the steps of delivering an ablation element into the tissue region, and activating the ablation element to create the cavity.

6. The method of claim 1, further comprising the step of introducing a sealant into the drug reservoir to seal the cavity from the vessel location.

7. The method of claim 1, wherein the step of using the cavity forming apparatus to form a cavity within the tissue region includes the step of removing a portion of the tissue region.

8. The method of claim 1 wherein the feedback element is selected from the group consisting of:

sensors, pressure sensors, flow sensors, thermocouples, temperature sensors, electrodes and electrocardiograph leads.

9. The method of claim 1 wherein the feedback element comprises an electrode for measuring electrical activity.

10. The method of claim 9 wherein the tissue region is within the heart and the electrode senses cardiac electrical activity.

11. The method of claim 1 wherein the determination of a physiological condition by the feedback element is used to ascertain when the puncturing element has reached a desired location within tissue.

12. The method of claim 1 wherein the determination of a physiological condition by the feedback element is used to ascertain when the delivery of the substance has caused a desired effect.

13. The method of claim 12 wherein the tissue is cardiac tissue and wherein the feedback element is used to determine when the delivery of the substance has brought about a desired change in cardiac electrical activity.

14. The method of claim 1 wherein feedback element is located on the puncturing element.

15. The method of claim 1 wherein feedback element is located on the substance delivery element.

16. The method of claim 1 wherein feedback element is located on the catheter element.