Devices, Systems and Methods for Acute or Chronic Delivery of Substances or Apparatus to Extravascular Treatment Sites

• US 20080051756A1
• Filed: 10/30/2007
• Published: 02/28/2008
• Est. Priority Date: 01/17/2002
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Chang, John, Tholfsen, David, Lamson, Theodore, Reggie, John, Flaherty, J. Christopher, Makower, Joshua, Catanese, Joseph
• Granted Patent: US 8,672,920 B2
• Time in Patent Office: Days
• US Class Current: 604/508
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• 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 2210/12 Blood circulatory system
• 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 5/007 for contrast media

Abstract

Methods and apparatus for delivery of substances or apparatus to target sites located outside blood vessels within the body of a human or animal patient. A vessel wall penetrating catheter is inserted into the vasculature, positioned and oriented within a blood vessel near the target extravascular site and a penetrator is advanced from the catheter so as to penetrate outwardly through the wall of the blood vessel in the direction of the target site. Thereafter, a delivery catheter is passed through a lumen of the penetrator to the target site. A desired substance or apparatus is then delivered to or obtained from the target site. In some applications, the penetrator may be retracted into the vessel wall penetrating catheter and the vessel wall penetrating catheter may be removed, leaving the delivery catheter in place for chronic or continuous delivery of substance(s) to and/or obtaining of information or samples from the target site. Alternatively, a delivery catheter having an occlusion member or balloon may be advanced into a vein or venule and the occlusion member or balloon may be used to occlude the lumen of the vein or venule during and after injection of a substance through the catheter, such that the substance will not be carried away by normal venous blood flow and will remain in the vein or venule for a sufficient period of time to have its intended effect (e.g. to enter adjacent tissues through capillary beds drained by that vein or venule).

Claims

1. A method for delivering a substance or article to one or more intramyocardial sites in the heart of a mammalian patient, the method comprising the steps of:

A. providing a tissue penetrating catheter system that comprises i) a catheter that is advanceable through the vasculature to a position within a chamber of the heart, ii) a tissue penetrator having a hollow bore extending therethrough, the penetrator being advancable from the tissue penetrating catheter, and iii) a delivery catheter that is advanceable through the bore of the penetrator and out of the penetrator into myocardial tissue;

B. inserting the tissue penetrating catheter into the patient'"'"'s vasculature and advancing the catheter to a position where the location on the catheter from which the tissue penetrator advances is located within a chamber of the patient'"'"'s heart;

C. advancing the tissue penetrator from the catheter, through the endocardium and into the myocardium;

D. advancing the delivery catheter through the bore of the penetrator and into the mycardial tissue; and

,

E. delivering the substance or article though the delivery catheter and into said one or more intramyocardial sites.

2. A method according to claim 1 wherein the penetrator is curved and wherein Step C further comprises advancing the curved penetrator to a position within the myocardium such that subsequent performance of Step D will not cause the delivery catheter to a) enter any chamber of the heart, b) pass outwardly through the epicardial surface of the heart and/or c) perforate any substantially sized coronary blood vessel in a manner that causes clinically significant bleeding or other clinically significant complications.

3. A method according to claim 2 wherein the penetrator is helically shaped and wherein Step C further comprises rotating the penetrator.

4. A method according to claim 2 further comprising the steps of:

F. retracting the delivery catheter into the bore of the penetrator;

G. repositioning the penetrator;

H. readvancing the delivery catheter through the bore of the repositioned penetrator and into the myocardium; and

,

I. delivering the substance or article though the delivery catheter and into said one or more additional intramyocardial sites that are different from the one or more intramyocardial sites into which the substance or article was delivered in Step E.

5. A method according to claim 4 wherein Steps F through G are repeated a plurality of times.

6. A method according to claim 1 wherein Steps D and E further comprise advancing the delivery catheter while periodically injecting the substance or article so as to deliver the substance or article into a plurality of spaced-apart intramyocardial sites.

7. A method according to claim 1 wherein Step E further comprises retracting the delivery catheter while periodically injecting the substance or article so as to deliver the substance or article into a plurality of spaced-apart intramyocardial sites.

8. A method according to claim 1 wherein Steps D and E further comprise advancing the delivery catheter while substantially continually injecting the substance or article so as to deliver a trail of the substance or article within the myocardial tissue.

9. A method according to claim 1 wherein Step E further comprises retracting the delivery catheter while substantially continually injecting the substance or article so as to deliver a trail of the substance or article within the myocardial tissue.

10. A method according to claim 1 wherein the penetrating catheter further comprises a guidance element useable by the operator to position the penetrating catheter body within the chamber of the heart vasculature of the heart such that when the penetrator is advanced from the catheter body it will penetrate through the endocardial surface and into the myocardiaum, and wherein Step C further comprises using said guidance element to position the penetrating catheter body within the chamber of the heart such that when the penetrator is advanced from the catheter body it will penetrate through the endocardium and into the myocardium.

11. A method according to claim 10 wherein the guidance element comprises an imaging apparatus and wherein Step C further comprises using the imaging apparatus to image at least one anatomical marker and using such image to guide the positioning of catheter such that the penetrator will enter the desired location of the myocardium.

12. A method according to claim 11 wherein the imaging apparatus is an ultrasound imaging apparatus and the image used in Step C is an ultrasound image.

13. A method according to claim 12 wherein the guidance element comprises indicia that indicates the path that will be followed by the penetrator when it is subsequently advanced from the catheter and wherein Step C further comprises obtaining an image of the imageable marker and using such image to guide the positioning of the penetrating catheter.

14. A method according to claim 10 wherein the guidance element comprises the combination of an imaging apparatus and at least one imageable marker on the penetrating catheter, and wherein Step C further comprises using the imaging apparatus to obtain an image of at least the imageable marker and using that image to guide the positioning of the penetrating catheter.

15. A method according to claim 14 wherein the imageable marker provides an indication of the direction in which the penetrator will advance and wherein Step C further comprises imaging of the imageable marker to obtain an indication of the direction in which the penetrator will advance and using said indication to rotationally orient the penetrating catheter such that subsequent advancement of the penetrator will cause the penetrator to travel in the direction of a desired intramyocardial site.

16. A method according to claim 10 wherein the guidance element comprises an emitter located on or in the catheter body, said emitter emitting a signal that is received by an extracorporeally situated signal-receiving apparatus and wherein Step C further comprises using an extracorporeally situated signal-receiving apparatus to receive a signal from the emitter and to thereby guide the placement of the penetrating catheter.

17. A method according to claim 1 wherein the system provided in Step A further comprises a guide catheter though which the penetrating catheter is advanceable and wherein, prior to performance of Step B, the method further comprises the step of:

inserting the guide catheter into the patient'"'"'s vasculature and advancing the guide catheter to a location within a chamber of the heart, and,

wherein Step B further comprises inserting the tissue penetrating catheter into the patient'"'"'s vasculature and advancing the tissue penetrating catheter through the guide catheter to a position where the location on the tissue penetrating catheter from which the tissue penetrator advances is located within a chamber of the patient'"'"'s heart.

18. A method according to claim 1 wherein the delivery catheter further comprises a position indicator for indicating the position of the delivery catheter within tissue and wherein the method further comprises the step of:

using the position indicator to discern the position of the delivery catheter within the patient'"'"'s body at at least one time during the procedure.

19. A method according to claim 18 wherein the position indicator comprises a radiographically visible marker and wherein the step of using the position indicator to discern the position comprises using a radiographic imaging apparatus to discern the location of the radiographically visible marker.

20. A method according to claim 1 wherein the method comprises advancing a delivery catheter through the penetrator and injecting a substance though the delivery catheter.

21. A method according to claim 20 wherein the method further comprises moving the delivery catheter while injecting the substance.

22. A method according to claim 21 wherein the delivery catheter is advanced while injecting the substance.

23. A method according to claim 21 wherein the delivery catheter is retracted while injecting the substance.

24. A method according to claim 18 wherein the substance is injected continuously while the delivery catheter is moved to deposit the substance over an elongate area or deposition.

25. A method according to claim 18 wherein boluses of the substance are injected at different times while the delivery catheter is moved to provide a plurality of discrete deposits of the substance at different locations on the path over which the delivery catheter was moved.

26. A method according to claim 1 further comprising the steps of:

obtaining a quantity of tissue or cellular matter for use as a tissue graft;

loading the tissue graft into the delivery catheter;

advancing the delivery catheter to an interstitial site; and

, delivering the tissue graft through the delivery catheter to the interstitial site.

27. A method according to claim 1 wherein a delivery catheter is advanced through the penetrator and to a location adjacent to an anatomical cavity, chamber or structure that the operator does not wish to penetrate with the delivery catheter and, wherein at least one of the penetrator and delivery catheter are of curved configuration such that the delivery catheter will advance through tissue on a path of advancement that is not directed into the anatomical cavity, chamber or structure that the operator does not wish to penetrate.

28. A method according to claim 27 wherein the delivery catheter is advanced into myocardial tissue adjacent to a chamber of the heart and at least one of the penetrator and delivery catheter are of a curved configuration that causes the delivery catheter to be advanced on a path of advancement that is generally tangential to the adjacent chamber of the heart, the delivery catheter being thereby advanced into the myocardial tissue without entering the chamber of the heart.