Exclusion of the left atrial appendage

• US 9,486,225 B2
• Filed: 12/22/2005
• Issued: 11/08/2016
• Est. Priority Date: 12/22/2005
• Status: Active Grant

• Current Assignee: Albert N. Santilli, Robert E. Michler
• Original Assignee: Albert N. Santilli, Robert E. Michler
• Inventors: Michler, Robert E., Santilli, Albert N.
• Primary Examiner(s): Anderson, Gregory
• Application Number:
  US11/315,799
• Publication Number:
  US 20070149988A1
• Time in Patent Office: 3,974 Days
• Field of Search: 606/151, 606/157, 606/158
• US Class Current: 1/1
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00584 Clips
• CPC Class Codes: A61B 2017/00632 Occluding a cavity, i.e. closing a blind opening

Abstract

A device for excluding the left atrial appendage (LAA) includes first and second members, each with first and second ends. The second ends are connected by a hinge. The first ends interlock to close the device about the LAA. The members are shaped such that they can exclude the LAA without causing the development of necrotic tissue. If desired, a flexible cover can be provided and the first and second members can be disposed within the cover. If such a cover is used, it will contact the LAA in order to cushion the contact between the members and the LAA and minimize the tendency of the LAA to bleed. The invention also includes methods for using the device to exclude the LAA.

Claims

1. A device for excluding the left atrial appendage (LAA), comprising:

a first member having first and second ends adapted to extend from one side of the LAA to the other and to contact the LAA on a selected side thereof adjacent the heart;

a second member having first and second ends adapted to extend from one side of the LAA to the other and to contact the LAA on the other side thereof adjacent the heart;

the first and second ends of the first and second members lying in a first plane;

a hinge that connects the second ends of the first and second members, the hinge being generally U-shaped and constituting an integral extension of the second ends of the first and second members to establish a structure that is closed at the second ends of the first and second members and open at the first ends of the first and second members when the first and second members are in a first, open position;

the first and second members being generally arc-shaped when viewed from above and lying in a second plane that is generally orthogonal to the first plane;

the first ends of the first and second members being movable in the first plane from the first, open position in which the LAA can fit therebetween to a second, closed position in which the first and second members are disposed generally parallel with each other and are sufficiently close to each other to compress the LAA between them without causing the development of necrotic tissue;

an interlock that connects the first ends of the first and second members to maintain the first and second members in a fixed position relative to each other when the first and second members are in the second, closed position;

those portions of the first and second members that contact the LAA being configured to minimize stress concentrations in the LAA, said portions being substantially round in cross-section; and

a flexible cover for the first and second members and the hinge, the cover being biocompatible with the LAA, the cover not extending beyond the first ends of the first and second members such that the device, when provided with the flexible cover, remains open at the first ends of the first and second members when the first and second members are in the first, open position and the interlock is exposed.

2. The device of claim 1, wherein those portions of the first and second members that come into contact with the LAA are round in cross-section.

3. The device of claim 1, wherein the first and second members, in cross-section, are round.

4. The device of claim 1, wherein the interlock is defined by:

a protrusion extending from the first end of a selected one of the first or second members, the protrusion being disposed approximately at a right angle to the member from which it extends, the protrusion having a tooth along its length; and

the first end of the other member being configured such that it can engage the tooth and thereby retain the first and second members in a fixed position relative to each other.

5. The device of claim 1, wherein the flexible cover is a mesh made of polyester fabric.

6. The device of claim 1, wherein the material from which the first and second members is made is biocompatible with the LAA.

7. The device of claim 6, wherein the material from which the first and second members is made is selected from the group consisting of titanium, titanium alloys, stainless steel, tantalum, tantalum alloys, and mixtures thereof.

8. The device of claim 1, wherein a selected one of the first and second members has an opening, and the cover is connected to the first and second members by being sewn to the opening.

9. The device of claim 1, wherein the protrusion has a plurality of teeth along its length and the first end of the other member being configured such that it can engage a selected tooth.

10. The device of claim 1, wherein the first and second ends of the first and second members have straight segments that lie in the first plane.

11. A device for excluding the left atrial appendage (LAA), comprising:

a first member having first and second ends adapted to extend from one side of the LAA to the other and to contact the LAA on a selected side thereof adjacent the heart;

a second member having first and second ends adapted to extend from one side of the LAA to the other and to contact the LAA on the other side thereof adjacent the heart;

the first and second ends of the first and second members lying in a first plane;

the first ends of the first and second members being movable in the first plane from a first, open position in which the LAA can fit therebetween to a second, closed position in which the first and second members are disposed generally parallel with each other and are sufficiently close to each other to compress the LAA between them without causing the development of necrotic tissue;

a hinge that connects the second ends of the first and second members, the hinge being generally U-shaped and constituting an integral extension of the second ends of the first and second members to establish a structure that is closed at the second ends of the first and second members and open at the first ends of the first and second members when the first and second members are in the first, open position;

the first and second members being generally arc-shaped when viewed from above and lying in a second plane that is generally orthogonal to the first plane;

the first end of a selected one of the first or second members being defined by a protrusion disposed approximately at a right angle to the member from which it extends, the protrusion having a tooth along its length and the first end of the other member being configured such that it can engage the tooth and thereby retain the first and second members in a fixed position relative to each other when the first and second members are in the second, closed position;

those portions of the first and second members that contact the LAA being substantially round in cross-section to minimize stress concentrations in the LAA; and

a flexible cover for the first and second members and the hinge, the cover being made of a material biocompatible with the LAA, the cover not extending beyond the first ends of the first and second members such that the device, when provided with the flexible cover, remains open at the first ends of the first and second members when the first and second members are in the first, open position and the interlock is exposed.

12. The device of claim 11, wherein the material from which the first and second members is made is selected from the group consisting of titanium, titanium alloys, stainless steel, tantalum, tantalum alloys, and mixtures thereof.

13. The device of claim 11, wherein those portions of the first and second members that contact the LAA are round in cross-section.

14. The device of claim 11, wherein a selected one of the first and second members has an opening, and the cover is connected to the first and second members by being sewn to the opening.

15. The device of claim 11, wherein the flexible cover is a mesh made of polyester fabric.

16. The device of claim 11, wherein the protrusion has a plurality of teeth along its length and the first end of the other member being configured such that it can engage a selected tooth.

17. The device of claim 11, wherein the first and second ends of the first and second members have straight segments that lie in the first plane.

18. A device for excluding the left atrial appendage (LAA), comprising:

a first member having first and second ends adapted to extend from one side of the LAA to the other and to contact the LAA on a selected side thereof adjacent the heart;

a second member having first and second ends adapted to extend from one side of the LAA to the other and to contact the LAA on the other side thereof adjacent the heart;

the first and second ends of the first and second members lying in a first plane;

the first ends of the first and second members being movable in the first plane from a first, open position in which the LAA can fit therebetween to a second, closed position in which the first and second members are disposed generally parallel with each other and are sufficiently close to each other to compress the LAA between them without causing the development of necrotic tissue;

a hinge that connects the second ends of the first and second members, the hinge being generally U-shaped and constituting an integral extension of the second ends of the first and second members to establish a structure that is closed at the second ends of the first and second members and open at the first ends of the first and second members when the first and second members are in the first, open position;

the first and second members and the hinge being made from a material selected from the group consisting of titanium, titanium alloys, stainless steel, tantalum, tantalum alloys, and mixtures thereof;

when viewed from above the first and second members having a central portion that is generally arc-shaped that lies in a second plane that is generally orthogonal to the first plane and the first and second ends of the first and second members having straight segments that lie in the first plane;

the first end of a selected one of the first or second members being defined by a protrusion disposed approximately at a right angle to the member from which it extends, the protrusion having a tooth along its length and the first end of the other member being configured such that it can engage the tooth and thereby retain the first and second members in a fixed position relative to each other when the first and second members are in the second, closed position;

those portions of the first and second members that contact the LAA being round in cross-section to minimize stress concentrations in the LAA;

a flexible fabric cover for the first and second members and the hinge, the cover being made of a material biocompatible with the LAA, the cover not extending beyond the first ends of the first and second members such that the device, when provided with the flexible cover, remains open at the first ends of the first and second members when the first and second members are in the first, open position and the protrusion and the first end of the other member are exposed; and

wherein a selected one of the first and second members has an opening, and the cover is connected to the first and second members by being sewn to the opening.

19. The device of claim 18, wherein the flexible cover is a mesh made of polyester fabric.

20. The device of claim 18, wherein the protrusion has a plurality of teeth along its length and the first end of the other member being configured such that it can engage a selected tooth.