IP Library Granted Patent US 12,290,694
Granted Patent B2
US 12,290,694 · App. 17/725,785 · Granted May 6, 2025

Atrial appendage occlusion and arrhythmia treatment

Inventors: David Zarbatany (Lake Forest, CA); Randell Werneth (Lake Forest, CA)
Assignee: Ventrimed Inc
A61N1/3756A61B17/0057A61B2017/00243A61B2017/00592A61B2017/00597A61B2017/00601A61B2017/00615
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Quick Facts
Patent No.
US 12,290,694
App. No.
17/725,785
Granted
May 6, 2025
Kind
B2
Abstract

Atrial appendage occlusion devices and cardiac monitoring positioned within the left atrial appendage and/or left atrium. In some embodiments the devices include an anchoring portion adapted to anchor the device in place adjacent the left atrial appendage, the anchoring portion comprising distal deformable anchoring portion adapted to be deployed in the left atrial appendage and a proximal deformable anchoring portion being adapted to be deployed in the left atrium, a barrier element secured to the anchoring portion and adapted to cover the left atrial appendage when implanted, and adapted to prevent blood clots from passing through the barrier element, and a cardiac monitoring element secured to at least one of the anchoring portions, the monitoring element including one or more sensors within in the left atrial appendage and/or left atrium and adapted to monitor left atrial cardiac data.

Claims (45)

1. A left atrial appendage (LAA) occlusion implant, comprising:

a proximal portion comprising multiple sized leaflets adapted to engage the atrial wall around the LAA, the multiple sized leaflets include:

a first set of leaflets sized to not obstruct blood flow through the mitral valve or the pulmonary vein; and

a second set of leaflets, larger than the first set of leaflets, sized to provide more surface contact with the atrial wall than the first set of leaflets,

the multiple sized leaflets having:

a frame element having a triangular or elliptical shape made from shape memory material with two ends coupled to a hub;

a barrier covering the frame element, the barrier being adapted to prevent blood clots from passing through the LAA;

wherein the frame element includes an outer portion adapted to collapse into a delivery configuration and self-expand when delivered; and

a distal portion comprising a plurality of anchors having a triangular or elliptical shape made of a shape memory material with two ends coupled to the hub, the plurality of anchors having an outer portion adapted to collapse into a delivery configuration and self-expand when delivered.

2. The implant of claim 1 , wherein a central portion of each frame element is adapted to bend outward to ease in the collapse of the frame element, and a central portion of each anchor is adapted to bend outward to ease in the collapse of the anchors.

3. The implant of claim 1 , wherein the multiple sized leaflets are adapted to overlap one another into a staggered orientation when collapsed.

4. The implant of claim 1 , wherein the multiple sized leaflets and anchors are adapted to be delivered through a delivery instrument.

5. A left atrial appendage (LAA) occlusion implant, comprising:

a proximal portion comprising multiple sized leaflets adapted to engage the atrial wall around the LAA, the multiple sized leaflets include:

a first set of leaflets sized to not obstruct blood flow through the mitral valve or the pulmonary vein; and

a second set of leaflets, larger than the first set of leaflets, sized to provide more surface contact with the atrial wall than the first set of leaflets;

the multiple sized leaflets having:

a frame element having a triangular or elliptical shape with two ends coupled to a tubular element;

a barrier covering the frame element, the barrier being adapted to prevent blood clots from passing through the LAA; and

a distal portion comprising a plurality of struts extending from the tubular element and adapted to expand within the LAA to secure the implant.

6. The implant of claim 5 , wherein the frame element is made of a shape memory material adapted to collapse into a delivery configuration and self-expand when delivered.

7. The implant of claim 5 , wherein the struts are made of a shape memory material and adapted to collapse into a delivery configuration and self-expand when delivered.

8. A left atrial appendage (LAA) occlusion implant, comprising:

a proximal portion comprising multiple sized leaflets adapted to engage the atrial wall around the LAA, the multiple sized leaflets include:

a first set of leaflets sized to not obstruct blood flow through the mitral valve or the pulmonary vein; and

a second set of leaflets, larger than the first set of leaflets, sized to provide more surface contact with the atrial wall than the first set of leaflets,

the multiple sized leaflets having:

a frame element having a triangular or elliptical shape with two ends coupled to a tubular hub;

a barrier covering the frame element, the barrier being adapted to prevent blood clots from passing through the LAA; and

a distal portion comprising a plurality of anchors with two generally straight sections extending from the tubular hub with a curved section in between.

9. The implant of claim 8 , wherein the frame element is made of a shape memory material adapted to collapse into a delivery configuration and self-expand when delivered in the LAA.

10. The implant of claim 8 , wherein the anchors are made of a shape memory material and adapted to collapse into a delivery configuration and self-expand when delivered.

11. A left atrial appendage (LAA) occlusion implant, comprising:

a proximal portion comprising:

a first set of leaflets sized to not obstruct the blood flow through the mitral valve or the pulmonary vein and made from shape memory material coupled to a hub in a first row; and

a second set of leaflets, larger than the first set of leaflets, sized to provide more surface contact with the atrial wall than the first set of leaflets and made from shape memory material coupled to a hub in a second row, the second set of leaflets disposed distally relative to first set of leaflets;

the second set of leaflets configured to overlap the first set of leaflets creating a barrier configured to engage the atrial wall around the LAA and seal off the LAA to prevent blood flow into the LAA; and

a distal portion comprising a plurality of anchors made of a shape memory material with a first end coupled to the hub and a second end configured to engage the LAA to secure the implant;

wherein the first set of leaflets, second set of leaflets, and plurality of anchors are configured to collapse into a delivery configuration such that they can be delivered endoluminally to the LAA in a delivery sheath or catheter, then self-expand once delivered to the LAA.

12. The implant of claim 11 , wherein the first and second leaflets include:

a frame having a triangular or elliptical shape with two ends coupled to the hub; and

a barrier covering the frame element, the barrier being adapted to prevent blood clots from passing through.

13. The implant of claim 11 , wherein the first set of leaflets are small leaflets and the second set of leaflets are large leaflets, the large leaflets having outer portions configured to extend further in the proximal direction than outer portions of the small leaflets.

14. The implant of claim 11 , wherein the first and second set of leaflets are adapted to overlap one another in a staggered orientation when collapsed into the delivery configuration.

15. The implant of claim 11 , wherein the first set of leaflets and the second set of leaflets are adapted to collapse downward in the proximal direction to be disposed within a delivery catheter, sheath, or other delivery instrument, and the plurality of anchors are adapted to collapse downward in the distal direction to be disposed within the delivery catheter, sheath, or other delivery instrument.

Continuity (4)
Continuation 15876128 · Jan 20, 2018
Continuation 13368685 · Feb 8, 2012
Provisional Application 61441627 · Feb 10, 2011
Related Publication 20220257955A1 · Aug 18, 2022
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