Stent delivery system and method of use

• US 6,196,230 B1
• Filed: 09/10/1998
• Issued: 03/06/2001
• Est. Priority Date: 09/10/1998
• Status: Expired due to Fees

• Current Assignee: Horizon Technology Funding Co. LLC (Horizon Technology Finance Management LLC)
• Original Assignee: Percardia, Inc.
• Inventors: Wilk, Peter J., Furnish, Simon M., Hall, Todd A., Wolf, Scott J., Phelps, David Y., Pompili, Vincent, Furnish, Greg R.
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US09/150,181
• Time in Patent Office: 908 Days
• Field of Search: 606/198, 606/194, 606/195, 606/1, 606/108, 606/200, 623/1, 623/12, 604/96, 600/16, 128/898
• US Class Current: 128/898
• 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 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61F 2/2493 Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/0197 for creating an artificial passage within the body, e.g. in order to go around occlusions
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1006 Balloons formed between concentric tubes
• CPC Class Codes: Y10S 623/903 Blood vessel

Abstract

Described herein are various methods and apparatuses for delivering stents and other devices into the myocardium of a patient. One preferred stent delivery system provides access to the insertion site in the myocardium by advancing a delivery catheter through a blockage in a coronary artery, or around the blockage through a coronary vein or through a channel or tunnel formed around the blockage. In one embodiment, once the distal end of the delivery catheter is adjacent the myocardium, an angled bend is created in the catheter by actuating expandable steering guides mounted to the catheter which cooperate with the walls of the blood vessel to cause the catheter to turn. Then, a guidewire is advanced through the delivery catheter and into the myocardium. In another embodiment, a tip-deflecting pull wire extends from the distal end of the delivery catheter which may be actuated to turn towards and then inserted into the myocardium. In another embodiment, an exit port facing the insertion site is provided within the catheter or a balloon mounted on the catheter so that a guidewire may be directed through a lumen and out the exit port into the myocardium. Once the guidewire punctures into the myocardium, the guidewire is anchored using barbs, balloons or other actuatable members to secure the guidewire to the myocardium. Subsequently, using a push-pull mechanism, stents and other medical devices can be advanced over the guidewire into the myocardium.

Claims

1. A method for delivering a medical device into the myocardium of a patient, comprising:

delivering a guidewire into the patient, the guidewire once delivered having a proximal end extending out of the patient and a distal end positioned adjacent the myocardium;

inserting the distal end of the guidewire into the myocardium;

creating a passage in the myocardium by expansion of an expandable member; and

after creating the passage, advancing an introducer catheter carrying the medical device over the guidewire to deliver the device into the myocardium.

2. The method of claim 1, wherein the guidewire is delivered percutaneously into the patient.

3. The method of claim 2, wherein the distal end of the guidewire is advanced through a blockage in a coronary artery.

4. The method of claim 2, wherein the distal end of the guidewire is advanced through a coronary vein.

5. The method of claim 2, wherein the distal end of the guidewire is advanced into the left ventricle.

6. The method of claim 1, further comprising advancing a delivery catheter into the patient prior to delivering the guidewire, the delivery catheter comprising a tubular body having a proximal end and a distal end and a lumen extending at least partially therethrough, until the distal end of the delivery catheter is positioned adjacent the myocardium.

7. The method of claim 6, further comprising turning the distal end of the guidewire toward the myocardium prior to inserting the distal end of the guidewire, by:

actuating an anchoring member mounted on the distal end of the delivery catheter to secure the delivery catheter within the patient; and

actuating a steering member mounted on the distal end of the tubular body at a position distal to that of the anchoring member to turn the distal end of the delivery catheter toward the myocardium; and

advancing the guidewire through the lumen in the delivery catheter and out the distal end of the delivery catheter.

8. The method of claim 1, wherein the guidewire is a tip-deflecting wire, and further comprising turning the distal end of the guidewire toward the myocardium prior to inserting the distal end of the guidewire by actuating the tip-deflecting wire.

9. The method of claim 1, further comprising:

providing a passageway adjacent the myocardium having a proximal opening for receiving the distal end of the guidewire and a side port exit facing the myocardium;

wherein delivering the guidewire comprises advancing the distal end of the guidewire through the passageway toward the myocardium.

10. The method of claim 9, wherein the passageway is provided through a lumen in a delivery catheter.

11. The method of claim 9, wherein the passageway is provided through an anchoring member mounted to a distal end of a delivery catheter.

12. The method of claim 1, further comprising anchoring the guidewire to the myocardium.

13. The method of claim 12, wherein anchoring the guidewire to the myocardium comprises providing at least one barb attached to the distal end of the guidewire, the barb having a shape that facilitates advancement of the guidewire distally through the myocardium but prevents retraction of the guidewire proximally.

14. The method of claim 1, wherein inserting the distal end of the guidewire into the myocardium comprises advancing the guidewire from a coronary blood vessel until the distal end extends into the left ventricle.

15. The method of claim 12, wherein anchoring the guidewire further comprises expanding an anchoring member mounted on the distal end of the guidewire within the left ventricle.

16. The method of claim 15, wherein the anchoring member is an inflatable balloon.

17. The method of claim 12, wherein advancing the introducer catheter carrying a medical device further comprises:

member into the aneurysm.

18. The method of claim 1, wherein the step of creating a passage includes advancing a second introducer catheter into the myocardium.

19. The method of claim 1, wherein the expandable member is inflatable.

20. The method fo claim 19, wherein the expandable member is a balloon.

21. A method for delivering a medical device into a body tissue of a patient comprising:

inserting a guidewire having a proximal end and a distal end into the myocardium from a coronary blood vessel;

anchoring the guidewire to the body tissue;

pushing the medical device over the guidewire into the body tissue; and

pulling on the proximal end of the guidewire while advancing the medical device through the body tissue.

22. The method of claim 21, wherein anchoring the guidewire comprises actuating an expandable member.

23. The method of claim 22, wherein the expandable member is an inflatable balloon.

24. The method of claim 21, further comprising providing at least one barb on the distal end of the guidewire to anchor the guidewire to the myocardium.

25. A method for delivering a stent into the myocardium of a patient to bypass a blockage formed in a coronary artery, comprising:

advancing a catheter having a proximal end and a distal end and a lumen extending at least partially therethrough from the proximal end to a distal opening through the coronary artery of the patient until the distal opening is past the blockage;

turning the catheter so that the distal opening faces the myocardium;

extending a wire having a proximal end and a distal end through the distal opening such that the distal end punctures into the myocardium;

anchoring the distal end of the wire to the myocardium;

delivering a dilation catheter over the wire, the catheter carrying a dilation balloon on a distal end thereof, until the balloon is within the myocardium;

inflating the dilation balloon to create an opening in the myocardium;

deflating the dilation balloon and removing the dilation catheter from the wire;

delivering a stent introducer catheter over the wire, the stent introducer catheter carrying a stent on a distal end thereof, until the stent is located within the opening in the myocardium, and

deploying the stent within the opening in the myocardium.

26. A method for creating a passage defined by a heart wall, comprising:

inserting a guidewire through the heart wall such that a portion of the guidewire rests in the heart wall;

positioning an expandable member over the portion of the guidewire in the heart wall;

expanding the expandable member within the heart wall to form the passage in the heart wall;

removing the expandable member from the heart wall; and

after removal of the expandable member, delivering a stent to the passage formed in the heart wall.

27. The method of claim 26, wherein positioning the expandable member includes disposing the expandable member on a catheter and advancing the catheter over the guidewire until the expandable member is over the portion of the guidewire in the heart wall.

28. The method of claim 26, wherein prior to inserting the guidewire through the heart wall, a distal end of the guidewire penetrates a wall of a coronary vessel.

29. The method of claim 28, wherein the coronary vessel is a coronary artery and the distal end of the guidewire penetrates the posterior wall of the coronary artery.

30. The method of claim 29, wherein the guidewire enters the coronary vessel percutaneously.

31. The method of claim 26, wherein the stent is configured to have a diameter such that the stent lies flush with the passage.

32. The method of claim 31, wherein delivering the expandable member includes advancing a first catheter over the guidewire, the expandable member being disposed on the first catheter, and wherein delivering the stent includes advancing a second catheter over the guidewire, the stent being disposed on the second catheter.

33. The method of claim 31, wherein delivering the stent includes delivering the stent in a collapsed configuration to the passage formed in the heart wall and expanding the stent in the passage so that the stent lies flush with the passage.

34. The method of claim 33, wherein expanding the stent includes providing a second expandable member which carries the stent during delivery to the passage and expanding the second expandable member in the passage to thereby expand the stent.

35. The method of claim 34, wherein expanding the expandable members includes inflating the expandable members.

36. The method of claim 33, wherein delivering the stent includes disposing the stent on a catheter and advancing the catheter over the guidewire and into the passage.

37. The method of claim 26, wherein the passage connects the left ventricle to the coronary artery.

38. The method of claim 26, wherein the expandable member and the stent are on separate catheters.