Apparatus and method for the ligation of tissue

• US 7,846,168 B2
• Filed: 10/11/2004
• Issued: 12/07/2010
• Est. Priority Date: 10/09/2003
• Status: Active Grant

• Current Assignee: SentreHeart, LLC (Atricure, Inc.)
• Original Assignee: SentreHEART Incorporated (Atricure, Inc.)
• Inventors: Cohn, William E., Liddicoat, John R., Laham, Roger
• Primary Examiner(s): Jackson; Gary
• Assistant Examiner(s): SZPIRA, JULIE ANN
• Application Number:
  US10/963,371
• Publication Number:
  US 20050154404A1
• Time in Patent Office: 2,248 Days
• Field of Search: 606/41, 606/1, 606/32, 606/49, 606/34, 606/200, 606/139, 606/191, 606/194, 606/148, 604/500, 604/508, 604/524, 604/526, 604/22, 604/107, 604/115, 607/5, 607/122, 607/126, 607/9, 128/887
• US Class Current: 606/139
• 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 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/12009 Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
• CPC Class Codes: A61B 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/30 Surgical pincettes without pivotal connectionsfor holding suture needles or materials A61B17/0483; wound clamps A61B17/08 ; hand-held gripping tools without pivotal connections in general B25B9/02
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/12018 Elastic band ligators
• CPC Class Codes: A61B 2017/308 with suction cups
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 2576/023 for the heart
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0127 Magnetic means; Magnetic markers
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A novel catheter-based system which ligates the left atrial appendage (LAA) on the outside of the heart, preferably using a combination of catheters and/or instruments, e.g., a guide catheter positioned inside the left atrial appendage which may assist in locating the left atrial appendage and/or assist in the optimal placement of a ligature on the outside of the appendage, and a ligating catheter and/or instrument outside the heart in the pericardial space to set a ligating element at the neck of the left atrial appendage.

Claims

1. A method for closing a left atrial appendage of a patient'"'"'s heart, comprising:

advancing a guide member transeptally into the left atrial appendage, wherein the guide member comprises an expandable element;

advancing a ligating assembly from the outside of a patient'"'"'s heart to a position adjacent to the left atrial appendage, wherein the ligating assembly comprises a support and a loop releasably attached to the support;

advancing the ligating assembly over an exterior surface of the left atrial appendage and over the expandable element so that the loop encircles the base of the left atrial appendage;

expanding the expandable element within the left atrial appendage;

closing the left atrial appendage with the ligating assembly;

confirming that the loop encircles the base of the left atrial appendage using fluoroscopy, echocardiographic guidance, or a combination thereof, prior to releasing the loop from the support;

releasing the loop from the support;

contracting and withdrawing the expandable element from the left atrial appendage; and

re-tightening the loop.

2. The method of claim 1, further comprising expanding the ligating assembly prior to advancing the ligating assembly over the exterior of the left atrial appendage, wherein the support comprises a plurality of struts, and wherein expanding the ligating assembly comprises radially expanding the plurality of struts.

3. The method of claim 2, wherein the plurality of struts radially expand into a bell-shaped crown.

4. The method of claim 1, wherein the loop comprises a ligature.

5. The method of claim 2, wherein the loop follows an arcuate path about the distal ends of the plurality of struts while the plurality of struts are radially expanded.

6. The method of claim 1, wherein the loop comprises a suture and the left atrial appendage is closed by tightening the suture around the left atrial appendage.

7. The method of claim 2, wherein the loop is released from the plurality of struts as the left atrial appendage is closed.

8. The method of claim 1, wherein the loop is radially contracted.

9. The method of claim 1, wherein the ligating assembly is advanced over a guidewire.

10. The method of claim 2, wherein the plurality of struts expands after exiting the distal end of a elongate tubular member.

11. The method of claim 2, wherein the plurality of struts are arranged in an arcuate configuration.

12. The method of claim 1, wherein the loop comprises polypropylene or PTFE.

13. The method of claim 1, further comprising grasping the left atrial appendage, wherein a tip of the left atrial appendage is grasped from outside the patient'"'"'s heart.

14. The method of claim 13, wherein grasping the left atrial appendage comprises applying a vacuum to the left atrial appendage.

15. The method of claim 1, wherein the ligating assembly is mounted on a distal region of an elongate member.

16. The method of claim 15, wherein the elongate member is inserted through an incision and advanced to a position adjacent the left atrial appendage.

17. The method of claim 16, wherein the incision is made over a second costal cartilage.

18. The method of claim 16, wherein the incision is made below the xyphoid process.

19. The method of claim 1, wherein the loop is radiopaque.

20. The method of claim 1, further comprising removing the ligating assembly.

21. The method of claim 20, wherein the loop remains closed around the left atrial appendage after removal of the ligating assembly.

22. The method of claim 1, wherein the ligating assembly is advanced through a pericardial space to a position adjacent the left atrial appendage.

23. The method of claim 22, wherein access to the pericardial space is obtained using a series of dilators.