METHOD AND APPARATUS FOR TRANSAPICAL ACCESS AND CLOSURE

• US 20120116418A1
• Filed: 06/27/2011
• Published: 05/10/2012
• Est. Priority Date: 06/26/2010
• Status: Active Grant

• Current Assignee: VasoStitch Inc (CardioLogical Solutions, Inc.)
• Original Assignee: VasoStitch Inc (CardioLogical Solutions, Inc.)
• Inventors: Belson, Amir, Burke, Phillip Charles, Johnson, Eric Thomas, Safa, Bauback
• Granted Patent: US 9,277,915 B2
• Time in Patent Office: Days
• US Class Current: 606/139
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/06 Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials puncturing needles A61B17/34; hypodermic needles A61M5/32 ; sewing needles D05B85/00
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3421 Cannulas
• 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 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/0243 for immobilizing local areas of the heart, e.g. while it beats
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
• CPC Class Codes: A61B 2017/06076 helically or spirally coiled
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs
• CPC Class Codes: A61B 2017/3405 using mechanical guide means
• CPC Class Codes: A61B 2017/3427 for intercostal space
• CPC Class Codes: A61B 2017/3458 threaded
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/00392 : Transmyocardial revascularisation

Abstract

Methods and apparatus for providing transapical access to a heart chamber for performing an intra cardiac procedure are described. The apparatus include a helical needle driver, a dilator, a straight access needle, and optionally a guidewire. After entering the heart chamber with the straight access needle, the helical needle driver is used to place a helical suture within the myocardium. After removing the needle driver, the dilator is advanced through the pre-placed helical suture, dilating both a passage and the circumscribing suture. After performing procedure, the pre-placed suture may be closed by proximally retracting an external end of the suture.

Claims

1. A method for transapical access to a heart chamber, said method comprising:

advancing a helical needle to helically position a suture through an apical region of the myocardium of the heart;

withdrawing the helical needle leaving the suture in place; and

dilating a passage through the helical suture into the heart chamber, wherein the passage maybe closed by drawing on the helical suture.

2. A method as in claim 1, wherein all methods steps are performed while the heart is beating.

3. A method as in claim 1, wherein tension is maintained on the pericardium to stabilize the heart while the helical needle is being advanced.

4. A method as in claim 3, wherein the helical needle is first passed through the pericardium surrounding the heart, the helical needle is then drawn proximally to tension the pericardium and stabilize the heart, and the helical needle is advanced into the myocardium while the tension is maintained on the pericardium.

5. A method as in claim 1, wherein the helical needle is first positioned adjacent the apical region of the heart via an intercostal approach.

6. A method as in claim 1, wherein the needle is first positioned adjacent the apical region of the heart via an subxiphoid approach.

7. A method as in claim 1, further comprising advancing a straight needle through the apical region prior to advancing the helical needle.

8. A method as in claim 6, further comprising visualizing advancement of the straight needle.

9. A method as in claim 6, wherein the helical needle is advanced over the straight needle.

10. A method as in claim 1, further comprising positioning a guiding apparatus through an intercostal penetration and through the myocardium, and advancing the dilator over said guiding apparatus while a counter traction is applied to the heart with the guiding apparatus.

11. A method as in claim 6, wherein a guidewire is placed through the straight needle and the helical needle is advanced over the guidewire.

12. A method as in claim 1, wherein advancing comprises advancing two or more helical needles simultaneously to position two or more helical sutures.

13. A method as in claim 12, wherein the two or more helical needles are coaxially nested with a radially inner needle and a radially outer needle.

14. A method as in claim 12, wherein the two or more helical needles are located in a common cylindrical envelope.

15. A method as in claim 14, wherein the needles have tissue penetrating tips which are rotationally offset.

16. A method as in claim 14, wherein the needles have tissue penetrating tips which are axially offset.

17. A method as in claim 1, wherein a distal end of the suture is anchored in the myocardium.

18. A method as in claim 17, wherein a distal portion of the suture has self-deploying barbs which anchor when the suture is tensioned proximally.

19. A method as in claim 1, wherein a distal end of the suture is anchored in the heart chamber.

20. A method as in claim 1, wherein a distal end of the suture has a T-bar anchor.

21. A method for performing a cardiac procedure, said method comprising:

accessing a heart chamber as in claim 1;

introducing at least one tool through the dilated passage while the helical suture remains in place;

performing the cardiac procedure with the at least one tool;

removing the at least one tool from the dilated passage; and

drawing on the suture to close the dilated passage.

22. A method as in claim 21, wherein the cardiac procedure comprises valve replacement.

23. A method as in claim 21, wherein the cardiac procedure comprises valve repair.

24. A method as in claim 21, wherein the cardiac procedure comprises left atrial appendage closure.

25. A method as in claim 21, wherein the cardiac procedure comprises cardiac ablation.

26. A method as in claim 21, wherein the cardiac procedure comprises closure of an atrial septal defect.

27. A method as in claim 21, wherein the cardiac procedure comprises closure of a patent foramen ovale.

28. A method as in claim 21, wherein the cardiac procedure comprising aneurysmectomy.

29. A system for establishing transapical access through myocardial tissue to a heart chamber, said system comprising:

a cylindrical shaft having a distal end, a proximal end, and a central passage extending between said ends;

a helical needle coupled to the distal end of the shaft;

suture releasably carried by the helical needle; and

a dilator having a width greater than that of the shaft, said dilator being adapted to be advanced over or in exchange for the shaft to enlarge a passage through the suture which is left in place through the myocardium.

30. A system as in claim 29, further comprising a sheath for accessing the pericardium over an apical region of the heart through an intercostal access site, wherein the cylindrical shaft is adapted to be advanced through the sheath.

31. A system as in claim 29, further comprising a sheath for accessing the pericardium over an apical region of the heart through a subxiphoid approach, wherein the cylindrical shaft is adapted to be advanced through the sheath.

32. A system as in claim 29, wherein the helical needle is fixedly attached to the distal end of the cylindrical shaft so that the needle is advanced through tissue by rotating the shaft.

33. A system as in claim 29, further comprising a driver for rotating the helical needle relative to the cylindrical shaft to advance the helical needle through tissue.

34. A system as in claim 29, wherein the helical needle is hollow and the suture is received in the needle.

35. A system as in claim 29, wherein the suture carries barbs along a distal region, wherein the barbs are adapted to self-deploy to anchor in myocardial tissue as the helical needle is withdrawn.

36. A system as in claim 29, wherein the suture carries a T-bar to anchor in a heart chamber as the helical needle is withdrawn.

37. A system as in claim 29, further comprising a straight needle for initially accessing the heart chamber through the myocardium.

38. A system as in claim 37, wherein the cylindrical shaft and helical needle are adapted to be advanced over the straight needle.

39. A system as in claim 37, wherein the needle is adapted to position a guidewire through the myocardium and the cylindrical shaft and helical needle are adapted to be advanced over the guidewire.

40. A system as in claim 29, wherein the dilator has a threaded exterior to facilitate advancement through tissue.

41. A system as in claim 29, wherein the dilator comprises an outer sleeve and an inner obturator, wherein the obturator can be removed to leave the sleeve in place in a dilated tissue tract.

42. A system as in claim 41, wherein the sleeve includes a hemostatic valve.