METHODS AND DEVICES FOR INTRA-ATRIAL SHUNTS HAVING ADJUSTABLE SIZES

• US 20130178783A1
• Filed: 12/24/2012
• Published: 07/11/2013
• Est. Priority Date: 12/22/2011
• Status: Active Grant

• Current Assignee: Corvia Medical, Inc.
• Original Assignee: DC Devices Inc.
• Inventors: McNamara, Edward, Sutherland, Michael W., Forcucci, Stephen J., Finch, Matthew J.
• Granted Patent: US 8,951,223 B2
• Time in Patent Office: Days
• US Class Current: 604/9
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00584 Clips
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• 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: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2493 Transmyocardial revascularisation [TMR] devices
• 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

Devices and methods for treating heart disease by normalizing elevated blood pressure in the left and right atria of a heart of a mammal are disclosed. Devices may include an adjustable hydraulic diameter shunt portion which can be manually adjusted in vivo. Methods are provided for adjusting the flow rate of the devices in vivo.

Claims

1. An expandable device adapted for percutaneous delivery into a membrane of a patient'"'"'s heart, the device comprising:

an anchoring section comprising interconnected first and second anchors adapted to contact, respectively, first and second sides of the membrane;

a coil forming a tubular body having a longitudinal axis and first and second ends, the first end being attached to the anchoring section, the coil being adapted to permit blood to flow across the membrane at a first flow rate, the coil also having a ratcheting mechanism comprising a plurality of protrusions and a plurality of complementary recesses for receiving the protrusions configured so that when the second end is turned about the longitudinal axis to tighten the coil, the ratcheting mechanism releasably locks the tightening of the coil;

wherein turning the second end to tighten the coil adapts the coil to conduct blood across the membrane at a second flow rate that is different from the first flow rate.

2. The device of claim 1, wherein the coil further comprises a plurality of tangs, each of the tangs being adapted to be engaged to enable the first end to remain stationary when the second end rotated about the longitudinal axis to tighten the coil.

3. The device of claim 1, wherein the coil comprises at least one from the group consisting of stainless steel, MP35N, cobalt-chromium, a shape-memory type alloy, a super-elastic alloy, and a polymeric material.

4. The device of claim 1, wherein the membrane is the patient'"'"'s atrial septum.

5. A method for adjusting in vivo the hydraulic diameter of a shunt implanted in a membrane of a patient, the shunt comprising a coil forming a tubular body having a longitudinal axis and first and second ends, the first end being attached to an anchoring section, the coil being adapted to permit blood to flow across the membrane at a first flow rate, the coil also having a ratcheting mechanism comprising a plurality of protrusions and a plurality of complementary recesses for receiving the protrusions configured so that when the second end is turned about the longitudinal axis to tighten the coil, the ratcheting mechanism releasably locks the tightening of the coil, the method comprising the steps of:

using a catheter to access to the shunt; and

manipulating the coil to tighten or loosen the coil to adapt the coil to conduct blood across the membrane at a second flow rate that is different from the first flow rate.

6. The method of claim 5, wherein the first flow rate is greater than the second flow rate.

7. The method of claim 5, wherein the second flow rate is greater than the first flow rate.

8. The method of claim 5, wherein the coil further comprises a plurality of tangs, each of the tangs being adapted to be engaged to enable the first end to remain stationary when the second end rotated about the longitudinal axis to tighten the coil, and wherein the step of manipulating includes engaging at least one of the tangs to tighten or loosen the coil.

9. The device of claim 5, wherein the coil comprises at least one from the group consisting of stainless steel, MP35N, cobalt-chromium, a shape-memory type alloy, a super-elastic alloy, and a polymeric material.

10. The method of claim 5, wherein the membrane is the patient'"'"'s atrial septum.

11. The method of claim 10, further comprising the steps of evaluating patient'"'"'s heart condition at a time after the implantation of the shunt and determining a desirable value for the second flow rate through the shunt across the atrial septum.