TECHNICAL FIELD

The present disclosure relates to intravascular blood pumps such as ventricular assist devices (VADs), and more particularly relates to right ventricular assist devices (RVADs) and left ventricular assist devices (LVADs).

BACKGROUND

One prior art intravascular blood pump is described in U.S. Pat. No. 5,928,132 to Leschinsky, the entire contents of which are incorporated by reference herein. The Leschinsky device includes a catheter with an inflatable balloon positioned within a pumping chamber at or near a distal end of the catheter. The balloon is alternately inflated and deflated by an external pump drive. Deflation of the balloon within pumping chamber of the catheter allows blood to flow into the pumping chamber from the heart. Inflation of the balloon displaces the blood and causes the blood to be expelled from the catheter through outlet valves positioned, for example, on the pumping chamber, thereby supporting the heart. Leschinsky notes that with minor variations, such a device may be used as a right ventricular assist device.

Challenges exist in providing intravascular blood pumping devices that are optimally effective given variations in patient anatomy, such as differences in diameter of aorta or vena cava between patients. Design challenges relate to the need to balance maximizing cannula size for maximum blood flow and reducing cannula size to improve blood flow around and external to the cannula as well as permit smaller profiles for insertion through narrow portions of a patient's vasculature. Further, elements on the cannula itself may reduce or slow blood flow around the cannula. Improvements to device safety and manufacturability are also desired.

SUMMARY

In one aspect of the disclosure, an intravascular device for pumping blood includes a catheter comprising a membrane chamber located between a proximal end and a distal end of the catheter, an inflatable membrane disposed within the membrane chamber, and a valve chamber separate from the membrane chamber. The intravascular device includes a first one-way valve configured to permit blood flow in a first direction.

In another aspect of the disclosure, an intravascular device for pumping blood includes a catheter comprising a membrane chamber located between a proximal tube portion and a distal tube portion. The proximal and distal tube portions each have a profile, when viewed along a lengthwise direction of the device, smaller than the outer profile of the membrane chamber. An inflatable membrane is disposed within the membrane chamber. The intravascular device further includes a first one-way valve associated with a first valve chamber of the catheter, the first valve chamber having a profile, when viewed along a lengthwise direction of the device, smaller than the profile of the membrane chamber.

In yet another aspect of the disclosure, a system for pumping blood includes an intravascular device comprising a catheter comprising a membrane chamber located between a proximal end and a distal end of the catheter, an inflatable membrane disposed within the membrane chamber, and an inlet and an outlet positioned external to and in fluid communication with the membrane chamber. The system further includes a connector assembly configured to connect to the intravascular device and to a pump console and configured to allow settings on the pump console to be altered for use with the intravascular device.

In yet another aspect of the disclosure, a method of forming an intravascular device includes forming at least one valve chamber, the chamber comprising a one-way valve, forming a membrane chamber of an expandable material, the membrane chamber having an expanded configuration and a contracted configuration, coupling at least one valve chamber to the membrane chamber, and coupling a catheter tube to the valve chamber.

In yet another aspect of the disclosure, a method of assisting circulation of blood in a body includes inserting a catheter into a venous structure. The catheter comprises a membrane chamber located between a proximal end and a distal end of the catheter. An inflatable membrane is disposed within the membrane chamber. The catheter includes a first valve chamber forming a portion of or containing a first one-way valve configured to permit blood flow in a first direction, and the first one-way valve is positioned proximal to the membrane chamber. The method further includes positioning the catheter such that the first valve chamber is positioned substantially adjacent to one of a renal vein and a hepatic vein, expanding the membrane chamber from a contracted position to an expanded position, and cyclically supplying a fluid to the inflatable membrane to inflate and deflate the inflatable membrane. Inflation of the membrane permits blood to exit the catheter and deflation of the membrane permits blood to enter the catheter through the first one-way valve.

In yet another aspect of the disclosure, a method of assisting circulation of blood in a body includes inserting a catheter into an arterial structure. The catheter comprises a membrane chamber located between a proximal end and a distal end of the catheter, an inflatable membrane disposed within the membrane chamber, and a first valve chamber forming a portion of or containing a first one-way valve configured to permit blood flow in a first direction. The first valve chamber is positioned proximal to the membrane chamber. The method further includes positioning the catheter such that the first valve chamber is substantially adjacent to a renal artery, expanding the membrane chamber from a contracted position to an expanded position, and cyclically supplying a fluid to the inflatable membrane to inflate and deflate the inflatable membrane, wherein inflation of the membrane permits blood to exit the catheter through the first one-way valve and deflation of the membrane permits blood to enter the catheter.

In accordance with yet another aspect of the present disclosure, an intravascular device for pumping blood includes a catheter comprising a membrane chamber located between a proximal tube portion and a distal tube portion with a distal end. At least one one-way valve is located proximal to or distal to the membrane chamber. The at least one one-way valve is positioned along a length of the device and relative to the distal end such that when the distal end is positioned at a target location relative to a first vascular structure, the at least one one-way valve is positioned adjacent a second vascular structure different from the first vascular structure.

Additional objects, features, and/or other advantages will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the present disclosure and/or claims. At least some of these objects and advantages may be realized and attained by the elements and combinations particularly pointed out in the appended claims.

Both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the claims; rather the claims should be entitled to their full breadth of scope, including equivalents.

