Devices and methods for pericardial access

• US 20060247672A1
• Filed: 04/27/2005
• Published: 11/02/2006
• Est. Priority Date: 04/27/2005
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Inventors: Vidlund, Robert M., Schweich, Cyril J. Jr., Ekvall, Craig A., Santer, Jeffrey D.
• Application Number:
  US11/115,408
• Publication Number:
  US 20060247672A1
• Time in Patent Office: Days
• US Class Current: 606/190
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• 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 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61B 2017/3486 Balloon
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2090/036 abutting on tissue or skin

Abstract

Devices and methods for establishing pericardial access to facilitate therapeutic and/or diagnostic applications. Pericardial access is facilitated, in part, by a tissue grasping device that reliably holds pericardial tissue, even in the presence of fatty deposits. The tissue grasping portion may include a tissue penetrating tip, a tissue dilating distal section, a tissue retention neck, and a tissue stop. When advanced into the pericardium, the tip may serve to create an opening (e.g., pierce, cut, etc.) in the pericardium, the distal section may serve to dilate the opening, the neck may serve to hold the tissue upon recoil of the dilated opening, and the stop may serve to limit further penetration once tissue is retained in the neck.

Claims

1. A method for accessing the pericardial space of the heart, the method comprising:

from a remote location, inserting a portion of an access device through the pericardium such that the portion automatically is inserted to a predetermined depth beyond the pericardium; and

after inserting the portion through the pericardium, separating the pericardium from the epicardium via the inserted portion of the access device.

2. The method of claim 1, wherein the separating of the pericardium from the epicardium occurs without the use of suction.

3. The method of claim 1, wherein the separating of the pericardium from the epicardium occurs by engaging the portion with an inner surface of the pericardium.

4. The method of claim 1, wherein the inserting the portion of the access device includes inserting a distal portion of the access device, the distal portion comprising a dilation member and a region of reduced cross-section proximal the dilation member.

5. The method of claim 1, wherein the inserting the portion of the access device includes piercing the pericardium.

6. The method of claim 1, wherein the inserting the portion of the access device includes dilating the pericardium.

7. The method of claim 6, wherein dilating the pericardium includes elastically dilating the pericardium.

8. The method of claim 7, further comprising allowing the pericardium to elastically recoil around a region of reduced cross-section of the portion once the portion has been inserted to the predetermined depth.

9. The method of claim 7, wherein elastically dilating the pericardium includes elastically dilating the pericardium by an amount such that the pericardium can be separated from the epicardium without tearing the pericardium.

10. The method of claim 1, wherein the inserting of the portion of the access device such that the portion automatically is inserted to a predetermined depth includes inserting the portion until a region of enlarged cross-section of the portion abuts the pericardium, the region of enlarged cross-section being configured such that it cannot be inserted past the pericardium.

11. The method of claim 10, wherein the region of enlarged cross-section includes a shoulder.

12. The method of claim 1, wherein the separating of the pericardium from the epicardium includes retracting the portion in a proximal direction substantially opposite to the direction of insertion.

13. The method of claim 12, wherein retracting the portion includes releasing tissue less fibrous than the pericardium from the portion of the device.

14. The method of claim 13, wherein the less fibrous tissue includes at least one of epicardial tissue and myocardial tissue.

15. The method of claim 1, wherein the separating of the pericardium from the epicardium includes engaging the pericardium with a region of enlarged cross-section of the portion of the access device.

16. The method of claim 1, further comprising piercing the pericardium with a stylet.

17. The method of claim 1, wherein the access device includes a trocar and the method further comprises piercing the pericardium with a stylet received in a lumen of the trocar.

18. The method of claim 17, further comprising removing the stylet from the trocar after the pericardium is separated from the epicardium.

19. The method of claim 1, wherein the inserting of the portion of the access device through the pericardium includes inserting the portion through varying types of tissue layers making up the pericardium.

20. The method of claim 19, wherein inserting the portion through varying types of tissue layers includes inserting the portion through fibrous tissue and less-fibrous tissue.

21. The method of claim 20, wherein inserting the portion through the fibrous tissue includes inserting the portion through pericardial tissue.

22. The method of claim 21, wherein inserting the portion through less-fibrous tissue includes inserting the portion through fatty tissue.

23. The method of claim 22, wherein the fatty tissue is exterior to the pericardial tissue.

24. The method of claim 1, further comprising performing a medical procedure in the pericardial space.

25. The method of claim 24, wherein the medical procedure is chosen from a diagnostic or treatment procedure.

26. The method of claim 24, wherein the medical procedure is chosen from epicardial lead placement and pacing, cardiac repair, valve repair, left atrial appendge occlusion, pulmonary vein occlusion, cardiac ablation, drug delivery, cardiac tamponade relief, cardiac biopsy, and minimally invasive CABG.

27. The method of claim 24, further comprising delivering a medical device to the pericardial space.

28. The method of claim 27, wherein the delivering of the medical device includes delivering a medical device chosen from epicardial pacing leads, cardiac restraint devices, valve repair devices, left atrial appendage occlusion devices, pulmonary vein occlusion devices, cardiac ablation devices, drug delivery devices, cardiac tamponade relief devices, biopsy devices, and minimally invasive CABG devices.

29. The method of claim 24, further comprising inserting a medical tool into the pericardial space.

30. The method of claim 29, wherein the inserting of the medical tool includes inserting a medical tool chosen from at least one of catheters, sheaths, dilators, and guidewires into the pericardial space.

31. The method of claim 1, further comprising imaging the distal portion of the access device.

32. The method of claim 31, further comprising adjusting and/or confirming the position of the distal portion via the imaging.

33. The method of claim 1, further comprising advancing the access device toward the heart from one of a sub-xyphoid and intercostal approach.

34. The method of claim 1, further comprising traversing soft tissue and dermal layers with the access device prior to inserting the access device into the pericardium.

35. The method of claim 34, wherein the traversing the soft tissue and dermal layers includes percutaneously and/or surgically traversing the soft tissue and dermal layers.

36. A method for separating a first tissue layer from a second tissue layer that is less fibrous than the first tissue layer, so as to provide access to the space between the tissue layers, the method comprising:

inserting a portion of an access device through the first tissue layer such that the portion automatically is inserted to a predetermined depth beyond the first tissue layer;

engaging the first tissue layer with the inserted portion of the device; and

separating the first tissue layer from the second tissue layer by moving the inserted portion in a proximal direction substantially opposite to the direction of insertion.

37. The method of claim 36, wherein the separating of the first tissue layer from the second tissue layer occurs without the use of suction.

38. The method of claim 36, wherein the separating of the first tissue layer from the second tissue layer occurs without direct visualization of the layers.

39. The method of claim 36, wherein the moving of the portion to perform the separating step includes manipulating the portion from a location remote from the tissue layers.

40. The method of claim 36, further comprising dilating the first tissue layer.

41. The method of claim 40, wherein the dilating includes elastically dilating the first tissue layer.

42. The method of claim 40, wherein the dilating includes dilating tissue of the first tissue layer substantially without tearing the tissue.

43. The method of claim 40, wherein the dilating occurs during the inserting of the portion.

44. The method of claim 40, further comprising allowing the dilated tissue layer to recoil around a region of reduced cross-section of the portion.

45. The method of claim 36, further comprising inserting a medical instrument into the space between the separated tissue layers.

46-135. -135. (canceled)