Apparatus and method for the ligation of tissue

• US 10,327,780 B2
• Filed: 02/11/2016
• Issued: 06/25/2019
• Est. Priority Date: 10/09/2003
• Status: Active Grant

• Current Assignee: SentreHeart, LLC (Atricure, Inc.)
• Original Assignee: SentreHEART Incorporated (Atricure, Inc.)
• Inventors: Liddicoat, John R., Cohn, William E., Laham, Roger
• Primary Examiner(s): Tanner, Jocelin C
• Application Number:
  US15/041,777
• Publication Number:
  US 20160235412A1
• Time in Patent Office: 1,230 Days
• 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
• 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 positioning a ligating device near a patient'"'"'s heart comprising:

advancing a first alignment element transeptally into a left atrial appendage;

expanding an expandable element relative to the first alignment element;

advancing a second alignment element into a pericardial space from outside a patient'"'"'s heart;

aligning the first and second alignment elements to assist in positioning the ligating device, wherein the ligating device comprises a ligating element that is releasably secured to a nitinol structure; and

advancing the ligating element to the left atrial appendage.

2. The method of claim 1, wherein aligning the first and second alignment elements assists in positioning the ligating device in the pericardial space.

3. The method of claim 2, wherein aligning the first and second alignment elements assists in positioning the ligating device at a neck of the left atrial appendage.

4. The method of claim 1 further comprising ligating the left atrial appendage with the ligating element.

5. The method of claim 1, wherein advancing the ligating element to the left atrial appendage comprises advancing the ligating element relative to the second alignment element.

6. The method of claim 1, wherein the alignment elements are aligned end-to-end.

7. The method of claim 1, wherein each of the first and second alignment elements comprise magnets.

8. The method of claim 1, wherein the first alignment element is part of a guide device.

9. The method of claim 8, wherein the guide device further comprises the expandable element.

10. The method of claim 9, wherein the expandable element is an inflatable balloon.

11. The method of claim 9 further comprising expanding the expandable element within the left atrial appendage.

12. The method of claim 11 further comprising ligating the left atrial appendage with a ligating element, wherein the expanded expandable element is used to assist in positioning the ligating element around a neck of the left atrial appendage.

13. The method of claim 9, wherein the first alignment element comprises a magnet and the expandable element is positioned near a distal end of the guide device and proximal to the magnet.

14. The method of claim 1, wherein the second alignment element is part of the ligating device.

15. The method of claim 1, where in the first alignment element is visualized as it is advanced into the left atrial appendage.

16. The method of claim 15, wherein the first alignment element is visualized using fluoroscopy or ultrasound.

17. The method of claim 1, wherein the pericardial space is accessed by making an incision below the xiphoid process.

18. The method of claim 1, wherein the pericardial space is accessed by using a series of dilators.