Method and apparatus for transapical access and closure

• US 9,277,915 B2
• Filed: 06/27/2011
• Issued: 03/08/2016
• Est. Priority Date: 06/26/2010
• Status: Expired due to Fees

• 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
• Primary Examiner(s): Scherbel, Todd J
• Application Number:
  US13/169,454
• Publication Number:
  US 20120116418A1
• Time in Patent Office: 1,716 Days
• Field of Search: 606/139, 606/144, 606/148, 606/228
• US Class Current: 1/1
• 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 trocars attached to inner organs or inner body tissue A61B2017/3488
• 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 hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2017/06076 helically or spirally coiled for sutures A61B2017/06171
• 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:

positioning a guiding apparatus through a tissue tract through a myocardium of an apical region of the heart;

advancing a helical needle over the guiding apparatus to helically position a suture surrounding the tissue tract through the apical region of the myocardium of the heart, wherein an anchor on a terminal distal end of the suture anchors in the myocardium or in the heart chamber;

withdrawing the helical needle leaving the helical suture in place; and

dilating the tissue tract through the helical suture into the heart chamber;

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

performing a 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.

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

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

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

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

7. The method as in claim 1, wherein positioning the guiding apparatus comprises advancing a straight needle through the apical region prior to advancing the helical needle.

8. The method as in claim 7, further comprising visualizing advancement of the straight needle.

9. The method as in claim 7, wherein a guidewire is placed through the straight needle and the helical needle is advanced over the guidewire.

10. The method as in claim 1, wherein the guiding apparatus is positioned through an intercostal penetration and through the myocardium, and wherein dilating the tissue tract comprises advancing a dilator over said guiding apparatus while a counter traction is applied to the heart with the guiding apparatus.

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

12. The method as in claim 11, wherein the two or more helical needles are coaxially nested with a radially inner needle and a radially outer needle.

13. The method as in claim 11, wherein the two or more helical needles are located in a common cylindrical envelope.

14. The method as in claim 13, wherein the two or more helical needles have tissue penetrating tips which are rotationally offset.

15. The method as in claim 13, wherein the two or more helical needles have tissue penetrating tips which are axially offset.

16. The method as in claim 1, wherein the anchor on the distal end of the suture anchors in the myocardium.

17. The method as in claim 16, wherein the anchor comprises self-deploying barbs which anchor when the suture is tensioned proximally.

18. The method as in claim 1, wherein the anchor on the distal end of the suture anchors in the heart chamber.

19. The method as in claim 1, wherein the anchor comprises T-bar anchor.

20. The method as in claim 1, wherein the cardiac procedure comprises valve replacement.

21. The method as in claim 1 , wherein the cardiac procedure comprises valve repair.

22. The method as in claim 1, wherein the cardiac procedure comprises left atrial appendage closure.

23. The method as in claim 1, wherein the cardiac procedure comprises cardiac ablation.

24. The method as in claim 1, wherein the cardiac procedure comprises closure of an atrial septal defect.

25. The method as in claim 1, wherein the cardiac procedure comprises closure of a patent foramen ovale.

26. The method as in claim 1, wherein the cardiac procedure comprises an aneurysmectomy.