Endovascular splinting devices and methods

• US 20040225304A1
• Filed: 12/12/2003
• Published: 11/11/2004
• Est. Priority Date: 10/06/2000
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Myocor, Inc. (Edwards Lifesciences Corporation)
• Inventors: Simmon, Marc A., Vidlund, Robert M., Keith, Peter T., Mortier, Todd J., Schweich, Cyril J. Jr., Kalgreen, Jason, Schroeder, Richard F.
• Application Number:
  US10/735,269
• Publication Number:
  US 20040225304A1
• Time in Patent Office: Days
• US Class Current: 606/151
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0682 for applying U-shaped staples or clamps, e.g. without a forming anvil
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00907 for light
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/048 for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints

Abstract

A method for placing a splint assembly transverse a heart chamber includes providing an elongate member having a first end and a second end and a deployable heart-engaging assembly connected to at least the first end. The method includes advancing the elongate member through vasculature structure and into the heart chamber such that the first end of the elongate member extends through a first location of a wall surrounding the heart chamber and the second end extends through a second location of the heart chamber wall substantially opposite the first location. A deployable heart-engaging assembly is deployed such that it engages with a first exterior surface portion of the heart chamber wall adjacent the first location. The elongate member is secured with respect to the heart with a second heart-engaging assembly connected to the second end. The second heart-engaging assembly engages with a second exterior surface portion of the heart chamber wall adjacent the second location. A splint assembly includes an expandable heart-engaging assembly formed partially from portions forming the elongate member of the splint assembly. A delivery tool includes a tubular member configured to be advanced through vasculature structure and has a curved distal end.

Claims

1. A method for direct localized therapeutic treatment of myocardial tissue in heart having a pathological condition comprising the steps of:

a. identifying a target region of the myocardium;

b. applying material directly and substantially only to at least a portion of the myocardial tissue of the target region substantially identified in step (a) to physically modify the mechanical properties of said tissue.

2. The method of claim 1 wherein the modified mechanical properties include an increase in systolic performance.

3. The method of claim 1 wherein the modified mechanical properties include substantially no decrease in global diastolic performance.

4. The method of claim 1, wherein the material applied is passive.

5. The method of claim 1, wherein said target region includes a myocardial infarct.

6. The method of claim 1, wherein said target region at least in part underlies the papillary muscles associated with a cardiac valve.

7. The method of claim 6, wherein said cardiac valve is the mitral valve.

8. The method of claim 1, wherein said material applied to the myocardial tissue is a device.

9. The method of claim 1, wherein said material applied to the myocardial tissue comprises a polymer.

10. The method of claim 1, wherein said material applied to the myocardial tissue comprises a bioactive agent.

11. The method of claim 1, wherein said applying step includes employing a catheter.

13. The method of claim 1, wherein said applying step is preceded by performing a mini-thoracotomy.

14. The method of claim 1, wherein said applying step includes applying material intramyocardially.

12. The method of claim 12, wherein said catheter is employed percutaneously.

15. A method for direct localized therapeutic treatment of myocardial tissue in heart having a pathological condition comprising the steps of:

a. identifying a target region of the myocardium;

b. advancing an element across the septum of the heart to deliver material; and

c. applying said material directly and substantially only to at least a portion of the myocardial tissue of the target region substantially identified in step (a) to physically modify the mechanical properties of said tissue.

16. The method of claim 15 wherein the modified mechanical properties include an increase in systolic performance.

17. The method of claim 16 wherein the modified mechanical properties include substantially no decrease in global diastolic performance.

18. The method of claim 15 wherein the material applied is passive.

19. The method of claim 15, wherein said target region includes a myocardial infarct.

20. The method of claim 15 wherein said target region at least in part underlies the papillary muscles associated with a cardiac valve.

21. The method of claim 20 wherein said cardiac valve is the mitral valve.

22. The method of claim 15 wherein said material applied to the myocardial tissue is a device.

23. The method of claim 15 wherein said material applied to the myocardial tissue comprises a polymer.

24. The method of claim 15, wherein said material applied to the myocardial tissue comprises a bioactive agent.

25. The method of claim 15, wherein said applying step includes employing a catheter.

26. The method of claim 25, wherein said catheter is employed percutaneously.

27. The method of claim 15 wherein said applying step is preceded by performing a mini-thoracotomy.

28. The method of claim 15 wherein said applying step includes applying material intramyocardially.

29. The method of claim 15, further comprising the step of performing an additional therapeutic or diagnostic procedure either before or after said applying step employing access to the heart gained during said advancing step.

30. The method of claim 29, wherein said additional therapeutic or diagnostic procedure is one or more procedures selected from the set consisting of pressure monitoring, angiography, ablation, placement of pacing leads, electrophysiology mapping, and placement of LVAD cannulae.

31. The method of claim 15, wherein said advancing step comprises advancing an element across the atrial septum of the heart.

32. The method of claim 15, wherein said advancing step comprises advancing an element across the ventricular septum of the heart.

33. The method of claim 15, wherein said advancing step comprises advancing an element across both the atrial and ventricular septa of the heart.