Apparatus and methods for delivering devices for reducing left atrial pressure

• US 9,713,696 B2
• Filed: 05/20/2014
• Issued: 07/25/2017
• 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
• Primary Examiner(s): WEISBERG, AMY REGINA
• Application Number:
  US14/282,615
• Publication Number:
  US 20140350565A1
• Time in Patent Office: 1,162 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
• 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 delivering a device for regulating blood pressure between a patient'"'"'s left atrium and right atrium, the apparatus comprising:

one or more latching legs having a hook portion and a ramp portion disposed proximal to the hook portion;

a release ring coupled to the one or more latching legs, the release ring configured to move from a first position, where the release ring contacts a first section of the ramp portion such that the one or more latching legs extend radially outward, to 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 to release the device;

a pull chord coupled to the release ring, wherein actuation of the pull chord moves the release ring proximally from the first position to the second position; and

a catheter having a lumen, the one or more latching legs, the release ring, and the pull chord at least partially disposed within the lumen.

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

3. The apparatus of claim 2, wherein the device is configured to be disposed within the sheath in a contracted, delivery state.

4. The apparatus of claim 1, wherein the apparatus is configured to deliver the device to an atrial septum of the patient.

5. The apparatus of claim 1, further comprising a handle coupled to the pull chord and disposed at a proximal end of the catheter, wherein the pull chord is actuated via the handle.

6. The apparatus of claim 1, wherein the device comprises a first flared end region for placement in a right atrium, a second flared end region for placement in the left atrium, and a neck between the first and second flared end regions for placement at the atrial septum.

7. The apparatus of claim 1, further comprising a release ring base coupled to the release ring and the pull chord, wherein the pull chord moves the release ring base to move the release ring proximally from the first position to the second position.

8. The apparatus of claim 7, further comprising a spring coupled to the release ring base, the spring configured to bias the release ring towards the first position.

9. The apparatus of claim 8, further comprising an annular member disposed proximal to the release ring base and configured to maintain the spring between the release ring base and the annular member.

10. 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.

11. The apparatus of claim 1, wherein the catheter comprises a catheter end having an end lumen extending therethrough, and

wherein the one or more latching legs, the release ring, and the pull chord are at least partially disposed within the end lumen.

12. A method of delivering a device to a subject with heart pathology, the subject having a heart with an atrial septum having a fossa ovalis therein, the method comprising:

coupling a hook portion of a delivery apparatus to the device, the delivery apparatus comprising one or more latching legs having the hook portion and a ramp portion disposed proximal to the hook portion, a release ring coupled to the one or more latching legs, and a catheter having a lumen, the one or more latching legs and the release ring at least partially disposed within the lumen;

positioning the device across a puncture through the fossa ovalis; and

moving the release ring proximally via a pull chord from a first position, where the release ring contacts a first section of the ramp portion such that the one or more latching legs extend radially outward, to 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 to decouple the hook portion from the device such that the device engages the atrial septum.

13. The method of claim 12, further comprising inserting the device in a sheath, partially retracting the sheath such that the device engages the left side of the atrial septum, and then fully retracting the sheath such that the device is partially disposed in a right atrium.

14. The method of claim 12, wherein the one or more latching legs are configured to move the device longitudinally forward and longitudinally backward through a sheath.

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

16. The method of claim 12, wherein the device has first and second flared end regions and a neck region disposed therebetween.

17. The method of claim 16, wherein positioning the device comprises positioning the device across the puncture through the fossa ovalis such that the neck region is positioned in the puncture, and

wherein the first flared end region is disposed in a right atrium and the second flared end region is disposed in a left atrium.

18. The method of claim 12, further comprising identifying the middle of the 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 device is deployed away from the limbus, atrial wall, and the ridge between the inferior vena cava and coronary sinus.

19. The method of claim 12, wherein the heart pathology comprises at least one of heart failure, pulmonary congestion, pulmonary hypertension, or myocardial infarction.

20. A method of delivering a device to a subject with heart pathology, the subject having a heart with an atrial septum having a fossa ovalis therein, the method comprising:

coupling a hook portion of a delivery apparatus to the device, the delivery apparatus comprising one or more latching legs having the hook portion and a ramp portion disposed proximal to the hook portion, a release ring coupled to the one or more latching legs, and a catheter having a lumen and a center axis, the one or more latching legs and the release ring at least partially disposed within the lumen;

positioning the device across a puncture through the fossa ovalis at a non-perpendicular angle between the center axis of the catheter and an outer wall of the atrial septum; and

moving the release ring proximally via a pull chord from a first position, where the release ring contacts a first section of the ramp portion such that the one or more latching legs extend radially outward, to 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 to decouple the hook portion from the device such that the device engages the atrial septum.

21. A method of delivering a device to a subject with heart pathology, the subject having a heart with an atrial septum having a fossa ovalis therein, the method comprising:

coupling a hook portion of a delivery apparatus to the device, the delivery apparatus comprising one or more latching legs having the hook portion and a ramp portion disposed proximal to the hook portion, a release ring coupled to the one or more latching legs, and a catheter having a lumen and a center axis, the one or more latching legs and the release ring at least partially disposed within the lumen, the device comprising first and second flared end regions and a neck region disposed therebetween;

positioning the device across a puncture through the fossa ovalis using the delivery apparatus such that the second flared end region is disposed within an atrial chamber of the heart;

expanding the second flared end within the atrial chamber;

back tenting the fossa ovalis by pulling the delivery apparatus proximally such that the expanded second flared end at least partially engages an outer wall of the fossa ovalis; and

moving the release ring proximally via a pull chord from a first position, where the release ring contacts a first section of the ramp portion such that the one or more latching legs extend radially outward, to 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 to decouple the delivery apparatus from the device such that the device engages the fossa ovalis.

22. The method of claim 21, wherein the device is configured to be disposed within a sheath in a contracted, delivery state, and

wherein expanding the second flared end in the atrial chamber comprises retracting the sheath such that the second flared end expands in the atrial chamber when exposed from the sheath.

23. The method of claim 21, further comprising identifying the middle of the 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 device is deployed away from the limbus, atrial wall, and the ridge between the inferior vena cava and coronary sinus.

24. The method of claim 21, wherein the heart pathology comprises at least one of heart failure, pulmonary congestion, pulmonary hypertension, or myocardial infarction.

25. The method of claim 21, wherein positioning the device across the puncture through the fossa ovalis is executed at a non-perpendicular angle between a center axis of the catheter and an outer wall of the fossa ovalis.