METHODS AND APPARATUS FOR REDUCING LOCALIZED CIRCULATORY SYSTEM PRESSURE

• US 20140128796A1
• Filed: 01/13/2014
• Published: 05/08/2014
• Est. Priority Date: 04/20/2001
• Status: Abandoned Application

• Current Assignee: V-Wave Ltd.
• Original Assignee: V-Wave Ltd.
• Inventors: KEREN, Gad, KESTEN, Randy
• Application Number:
  US14/154,088
• Publication Number:
  US 20140128796A1
• Time in Patent Office: Days
• US Class Current: 604/9
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• 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 2/2493 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
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves
• CPC Class Codes: A61M 60/13 by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/165 implantable in, on, or around the heart
• CPC Class Codes: A61M 60/17 inside a ventricle, e.g. intraventricular balloon pumps
• CPC Class Codes: A61M 60/178 drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
• CPC Class Codes: A61M 60/216 including a rotating member acting on the blood, e.g. impeller
• CPC Class Codes: A61M 60/515 Regulation using real-time patient data
• CPC Class Codes: A61M 60/569 synchronous with the native heart beat
• CPC Class Codes: A61M 60/861 Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
• CPC Class Codes: A61M 60/892 Active valves, i.e. actuated by an external force
• CPC Class Codes: A61M 60/894 Passive valves, i.e. valves actuated by the blood
• CPC Class Codes: A61M 60/896 having flexible or resilient parts, e.g. flap valves

Abstract

The present invention is thus directed to methods and apparatus for decreasing pressure in a first portion of a vessel of the cardiac structure of a patient by implanting a shunt communicating with an area outside said first portion, whereby a volume of blood sufficient to reduce pressure in said first portion is released.

Claims

1. A system for delivering an implantable device to an atrial septum, the system comprising:

a sheath having a lumen and a distal opening, the sheath sized for percutaneous advancement across the atrial septum such that the distal opening is disposed within a left atrium;

a delivery catheter sized for advancement through the lumen of the sheath;

an implantable device configured to be coupled to the delivery catheter and sized to be advanced through the lumen of the sheath, the implantable device having a passageway configured to permit passage of blood therethrough and first and second self-expanding end regions; and

a control wire coupled to the implantable device, the control wire configured to permit independent translational control of the implantable device within the lumen of the sheath.

2. The system of claim 1, wherein the implantable device comprises a shunt having a first end adapted to communicate with the left atrium and a second end adapted to communicate with a right atrium.

3. The system of claim 1, wherein the first and second self-expanding regions are configured to be compressed in the lumen of the sheath.

4. The system of claim 3, wherein the lumen of the sheath has a lumen diameter and the first and second self-expanding regions each have a diameter, and

wherein the diameter is greater than the lumen diameter.

5. The system of claim 1, wherein the implantable device has a valve disposed therein, the valve configured to open to permit blood to flow from the left atrium to a right atrium only when the left atrial pressure exceeds a pressure in the right atrium.

6. The system of claim 1, further comprising radiopaque markers disposed on at least one of the delivery catheter and the sheath.

7. The system of claim 1, wherein at least one of the delivery catheter and the sheath are configured to permit fluoroscopic visualization thereof.

8. The system of claim 1, wherein the control wire is configured to detach from the implantable device upon receipt of a prescribed tension level.

9. The system of claim 1, further comprising at least one of a needle and a guidewire configured for transseptal puncture.

10. The system of claim 1, wherein the first self-expanding end region is configured to provide tactile feedback once deployed.

11. The system of claim 1, further comprising at least one of hemodynamic and ECG monitoring equipment configured to measure patient vital signs.

12. A method for delivering an implantable device to an atrial septum in a patient, the method comprising:

percutaneously delivering a sheath across the atrial septum such that a distal opening of the sheath is disposed within a left atrium;

advancing a delivery catheter coupled to an implantable device through a lumen of the sheath;

retracting the sheath such that a first self-expanding end region of the implantable device expands in the left atrium;

further retracting the sheath such that a second self-expanding end region of the implantable device expands in the right atrium and the implantable device is secured at the atrial septum to permit blood to flow through the implantable device; and

removing the sheath and the delivery catheter from the patient.

13. The method of claim 12, further comprising translating the implantable device within the sheath using a control wire coupled to the implantable device.

14. The method of claim 13, further comprising applying tension to the control wire to detach the control wire from the implantable device.

15. The method of claim 12, wherein percutaneously delivering comprises percutaneously delivering the sheath via a femoral vein access point.

16. The method of claim 12, further comprising, prior to percutaneously delivering the sheath, percutaneously delivering at least one of a needle and a guidewire to the atrial septum and puncturing the atrial septum.

17. The method of claim 16, wherein the sheath is delivered over the guidewire,

18. The method of claim 12, further comprising visualizing at least one of the delivery catheter and the sheath prior to removing the sheath and the delivery catheter.

19. The method of claim 12, further comprising, after retracting the sheath such that the first self-expanding end region of the implantable device expands, providing tactile feedback that first self-expanding end region is seated against the atrial septum.

20. The method of claim 12, wherein the first and second self-expanding end regions are configured to expand to engage opposing sides of the atrial septum.

21. The method of claim 12, further comprising measuring patient vital signs using at least one of hemodynamic and ECG monitoring equipment.