Surgical stabilizer and closure system

• US 9,226,824 B2
• Filed: 11/21/2011
• Issued: 01/05/2016
• Est. Priority Date: 11/30/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Miraki, Manouchehr
• Primary Examiner(s): Nguyen, Victor
• Assistant Examiner(s): EVERAGE, KEVIN D
• Application Number:
  US13/301,515
• Publication Number:
  US 20120136200A1
• Time in Patent Office: 1,506 Days
• Field of Search: 623/2.11, 606/108, 606/222, 606/223, 606/226, 604/27, 604/28, 604/158, 604/264, 604/506
• US Class Current: 1/1
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• 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 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0243 for immobilizing local areas of the heart, e.g. while it beats
• CPC Class Codes: A61B 2017/0406 Pledgets
• 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 2017/061 hollow or tubular
• CPC Class Codes: A61B 2017/3425 for internal organs, e.g. heart ports
• CPC Class Codes: A61B 2017/3427 for intercostal space
• CPC Class Codes: A61B 90/50 Supports for surgical instruments, e.g. articulated arms
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61M 2025/0095 being one or more needles protruding from the distal tip and which are not used for injection nor for electro-stimulation, e.g. for fixation purposes
• CPC Class Codes: A61M 25/04 : in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

A system for stabilizing the heart via a helical needle, providing access to the interior of the heart via an introducer sheath, and forming a purse string suture using suture delivered by the helical needle. A helical needle projects distally from the device and terminates in a sharp distal tip. The helical needle is advanced into the heart wall, and is used to stabilize the heart and to pass a purse string suture through the heart tissue. An access port provides access to the interior of the heart via an opening passing through the heart wall in an area circumscribed by the helical needle. The helical needle may have a deflection segment adjacent the distal tip that is more flexible than the rest of the helical distal portion of the helical needle.

Claims

1. A method of accessing the interior of a heart using a device comprising an access port with at least one generally helical needle at a distal end thereof, the method comprising:

positioning a distal end of the generally helical needle against an apex of the heart;

advancing the generally helical needle into the heart wall at the apex of the heart without penetrating the interior of the heart, comprising rotating the helical needle in a first rotational direction with the distal end of the generally helical needle held against the apex of the heart;

stabilizing the heart by securing the access port and generally helical needle in a generally fixed position;

creating a puncture through the heart wall and into the interior of the heart at the apex of the heart using a puncture needle;

advancing a treatment instrument into the interior of the heart via the access port and the puncture;

performing a procedure on the heart using the treatment instrument;

removing the treatment instrument from the interior of the heart;

removing the generally helical needle from the heart wall at the apex of the heart, comprising rotating the generally helical needle in a second rotational direction, wherein the second rotational direction is opposite to the first rotational direction, wherein removing the generally helical needle from the heart wall occurs after performing the procedure on the heart using the treatment instrument.

2. The method of claim 1, wherein creating the puncture through the heart wall occurs after advancing the generally helical needle into the heart wall at the apex of the heart, and wherein the puncture is located in an area of the heart wall at least partially circumscribed by the generally helical needle.

3. The method of claim 1, wherein creating the puncture through the heart wall occurs before advancing the generally helical needle into the heart wall at the apex of the heart, and wherein the generally helical needle, as it advances into the heart wall, at least partially circumscribes the puncture through the heart wall.

4. The method of claim 1, wherein the device comprises a length of suture carried along the length of a distal portion of the generally helical needle, with a free end of the length of suture positioned at or adjacent a distal tip of the helical needle.

5. The method of claim 4, wherein the helical needle includes a deflection segment adjacent the distal tip that is more flexible than the rest of the distal portion of the helical needle, wherein the free end of the length of suture is at or adjacent the deflection segment, the method including deflecting the deflection segment in a proximal direction to direct the free end of the length of suture out of the heart wall tissue.

6. The method of claim 4, wherein the device further includes an inner needle arranged to translate through the helical needle and extend from the distal tip thereof, a portion of the length of suture positioned at the distal end portion of the inner needle, the inner needle having a relaxed shape at the distal end portion thereof that has a proximal bend so that it deflects in a proximal direction with respect to the helical needle when extended from the distal tip of the helical needle, the method including translating the inner needle along the helical needle so that the distal end portion of the inner needle extends from the distal tip of the helical needle and deflects in a proximal direction to direct the portion of the length of suture out of the heart wall tissue.

7. The method of claim 6, wherein the inner needle is hollow and the length of suture extends therethrough, the method including deflecting the distal end portion out of the tissue and grasping the portion of the length of suture.

8. The method of claim 4, further comprising:

securing the free end of the length of suture at a position outside of the heart wall, wherein securing the free end of the length of suture occurs prior to removing the generally helical needle from the heart wall at the apex of the heart;

after removing the generally helical needle from the heart wall, leaving a proximal portion of the length of suture extending from the point of entry of the helical needle;

applying tension to the free end and proximal portion of the length of suture to cinch the heart wall tissue and close the puncture.

9. The method of claim 8, wherein the treatment instrument includes an introducer sheath carrying a heart valve, and performing a procedure on the heart comprises performing a heart valve replacement using the introducer sheath extending through the puncture.

10. The method of claim 1, wherein the site of puncture is the apex of a ventricle, and wherein the puncture needle includes an inner lumen and distal opening, and the method further comprises:

installing a guidewire through the puncture needle inner lumen and into the ventricle;

wherein advancing the treatment instrument into the interior of the heart via the access port and the puncture comprises advancing the treatment instrument over the guidewire.