APPARATUS AND METHODS FOR DELIVERING DEVICES FOR REDUCING LEFT ATRIAL PRESSURE

• US 20170319823A1
• Filed: 07/21/2017
• Published: 11/09/2017
• Est. Priority Date: 05/21/2013
• Status: Active Grant

• Current Assignee: V-Wave Ltd.
• Original Assignee: V-Wave Ltd.
• Inventors: Yacoby, Menashe, Harari, Boaz, NITZAN, Yaacov
• Granted Patent: US 10,478,594 B2
• Time in Patent Office: Days
• 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 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00601 Implements entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202

Abstract

A device for regulating blood pressure between a patient'"'"'s left atrium and right atrium, and apparatus for delivery the device, are provided. The delivery apparatus may include one or more latching legs, a release ring, a pull chord, and a catheter wherein the latching legs are configured to engage the device for delivery. The inventive devices may reduce left atrial pressure and left ventricular end diastolic pressure, and may increase cardiac output, increase ejection fraction, relieve pulmonary congestion, and lower pulmonary artery pressure, among other benefits. The inventive devices may be used, for example, to treat subjects having heart failure, pulmonary congestion, or myocardial infarction, among other pathologies.

Claims

1. An apparatus for coupling to an atrial shunt for regulating blood pressure between a patient'"'"'s left atrium and right atrium, the apparatus comprising:

a catheter having a proximal region and a distal region, the distal region sized and shaped to be advanced to the patient'"'"'s atrial septum;

one or more latching legs disposed at the distal region of the catheter, the one or more latching legs having a hook portion and a ramp portion disposed proximal to the hook portion;

a ring coupled to the one or more latching legs; and

an actuator disposed at the proximal region of the catheter, the actuator configured to move the ring between a first position, where the ring contacts a first section of the ramp portion such that the one or more latching legs extend radially outward, and a second position, where the release ring contacts a second section of the ramp portion such that the one or more latching legs move radially inward.

2. The apparatus of claim 1, wherein the apparatus is configured to deliver the atrial shunt to the atrial septum of the patient such that a first flared end region of the atrial shunt is disposed in the right atrium in an expanded state, a second flared end region of the atrial shunt is disposed in the left atrium in an expanded state, and a neck region between the first and second flared end regions is positioned at the atrial septum.

3. The apparatus of claim 1, wherein the catheter comprises a lumen extending between the proximal region and the distal region of the catheter.

4. The apparatus of claim 3, wherein the one or more latching legs and the ring are at least partially disposed within the lumen.

5. The apparatus of claim 1, further comprising a sheath, wherein the catheter is configured to be at least partially disposed within the sheath.

6. The apparatus of claim 5, wherein the sheath is configured to receive the atrial shunt in a contracted state.

7. The apparatus of claim 1, further comprising a pull chord coupled to the ring, wherein the actuator is configured to move the pull chord to move the ring between the first position and the second position.

8. The apparatus of claim 1, further comprising a ring base coupled to the ring and the actuator, wherein the actuator causes the ring base to move the ring between the first position and the second position.

9. The apparatus of claim 8, further comprising a spring coupled to the ring base, the spring configured to bias the ring toward the first position.

10. The apparatus of claim 9, further comprising an annular member disposed proximal to the ring base and configured to maintain the spring between the ring base and the annular member.

11. The apparatus of claim 1, wherein the one or more latching legs comprise two latching legs that share a common ramp portion and a third latching leg having a separate ramp portion.

12. The apparatus of claim 1, wherein the hook portion of the one or more latching legs hooks outwardly away from a center axis of the catheter.

13. A method of coupling to an atrial shunt configured for implantation at an atrial septum, the method comprising:

advancing a distal region of a catheter of an apparatus to the atrial septum, the apparatus further comprising an actuator at a proximal region of the catheter, one or more latching legs disposed at the distal region of the catheter and having a hook portion and a ramp portion disposed proximal to the hook portion, and a ring coupled to the one or more latching legs; and

actuating the actuator to move the ring between a first position, where the ring contacts a first section of the ramp portion such that the one or more latching legs extend radially outward, and a second position, where the ring contacts a second section of the ramp portion such that the one or more latching legs move radially inward.

14. The method of claim 13, wherein the advancing further comprises advancing the atrial shunt in a sheath, the method further comprising:

expanding a second flared end of the atrial shunt from the sheath such that the atrial shunt engages the left side of the atrial septum; and

retracting the sheath such that a first flared end of the atrial shunt expands and is disposed in a right atrium.

15. The method of claim 13, wherein the one or more latching legs are configured to move the atrial shunt longitudinally forward and longitudinally backward through a sheath.

16. The method of claim 13, further comprising positioning the atrial shunt across a puncture through a fossa ovalis such that a neck region of the atrial shunt is positioned in the puncture, and wherein a first flared end region of the atrial shunt is disposed in a right atrium in an expanded state and a second flared end region is disposed in a left atrium in an expanded state.

17. The method of claim 16, wherein positioning the atrial shunt comprises positioning the atrial shunt across the puncture through the fossa ovalis at a non-perpendicular angle between a center axis of the catheter and an outer wall of the atrial septum.

18. The method of claim 16, wherein positioning the atrial shunt comprises back tenting the fossa ovalis by pulling the apparatus proximally such that the expanded second flared end of the atrial shunt at least partially engages an outer wall of the fossa ovalis.

19. The method of claim 13, further comprising identifying a middle of a fossa ovalis of the atrial septum by pressing a needle against the fossa ovalis to partially tent the fossa ovalis, and puncturing the middle of the fossa ovalis with the needle such that the atrial shunt is deployed away from a limbus, an atrial wall, and a ridge between an inferior vena cava and coronary sinus.

20. The method of claim 13, wherein the atrial shunt is configured for implantation at an atrial septum of a patient having a heart pathology comprising at least one of heart failure, pulmonary congestion, pulmonary hypertension, or myocardial infarction.