A cardiac assist system includes a pneumatic effector which is implanted beneath a pericardial sac and over a myocardial surface overlying the patient's left ventricle. A port is implanted and receives a percutaneously introduced cannula. The port is connected to supply a driving gas received from the cannula to the pneumatic effector. An external drive unit includes a pump assembly and control circuitry which operate the pump to actuate the pneumatic effector in response to the patient's sensed heart rhythm. A connecting tube has a pump end connected to the pump and a percutaneous port-connecting end attached to the implantable port.

A cardiac assist system includes a pneumatic effector which is implanted beneath a pericardial sac and over a myocardial surface overlying the patient's left ventricle. A port is implanted and receives a percutaneously introduced cannula. The port is connected to supply a driving gas received from the cannula to the pneumatic effector. An external drive unit includes a pump assembly and control circuitry which operate the pump to actuate the pneumatic effector in response to the patient's sensed heart rhythm. A connecting tube has a pump end connected to the pump and a percutaneous port-connecting end attached to the implantable port.

A dual balloon catheter having two independently inflatable balloons that provides complete or intermittent synchronous occlusion of blood vessels (such as the contralateral iliac veins, for example) via the balloons, which can be used for the purpose of decreasing the pressure in the inferior vena cava, which results in decongestion of the kidneys, liver/splanchnic compartment, lymphatic system, and the heart.

Some embodiments of percutaneous ventricular assist devices have a two-part design that includes a housing component and a separately deployable rotatable inner catheter component. The housing component can include an expandable pump housing. The inner catheter can include an expandable pump impeller and an associated flexible drive shaft. The drive shaft can be coupled to a motor located external to the patient. The motor can rotate the drive shaft to spin the pump impeller inside of the pump housing, causing blood to be pumped within the patient. In some embodiments, the pump impeller is inflatable or self-expandable. The two-part percutaneous ventricular assist devices with inflatable or self-expandable pump impellers are designed to have very small delivery profiles. Accordingly, various deployment modalities, including radial artery deployment, are practicable using the two-part percutaneous ventricular assist devices described herein.

Diffusion and infusion resistant implantable devices and methods for reducing pulsatile pressure are provided. The implantable device includes a balloon implantable within a blood vessel of a patient, e.g., the pulmonary artery. The balloon is injected with a fluid mixture comprising a constituent fluid(s) and a diffusion-resistant gas to provide optimal balloon volume and limit fluid diffusion throughout multiple cardiac cycles. The fluid mixture may be pressurized such that the balloon is transitionable between an expanded state and a collapsed state responsive to pressure fluctuations in the blood vessel.

Apparatus, systems, and methods are provided for optimizing intracardiac filling pressures and cardiac output in patients with heart failure, conduction disease, and atrial fibrillation. The system is able to adjust and optimize intracardiac filling pressures and cardiac output by adjusting heart rate and the effective amount of total body blood volume. The device includes an adjustable member that may create a mean pressure differential in order to manifest an effective “mechanical diuresis” by sequestering extraneous blood volume to the high-capacitance of the venous vasculature. The system is therefore designed to reduce intracardiac filling pressures while maintaining or even increasing cardiac output.

Several embodiments of a catheter are described, having a balloon configured to slowly inflate and then quickly deflate to create an area of low pressure in the vessels. The balloon can be cycled near the vessels of the kidneys, thereby helping to draw out blood from the kidneys and enhance fluid processing to the bladder.

The invention relates to a catheter assembly for the intermittent occlusion of the coronary sinus (CS, 60). The catheter assembly comprises a shaft (17, 126). The shaft (17, 126) has a plurality of lumens (7A, 7B, 35, 38, 40, 40A, 40B), a distal end (22) with a distal tip (20A, 20B, 20C), an occlusion device (24, 56, 142) fixed to the distal tip (20A, 20B, 20C) and operable through at least one of the plurality of lumens (7A, 7B, 35, 38, 40, 40A, 40B) and a proximal handle (10). The catheter assembly further having at least one of the following: the occlusion device (24, 142) having a diameter of 5 - 20 mm and adapted to occlude the coronary sinus ostium, means of measuring the pressure at the distal tip (20 a, 20B, 20C) of the catheter assembly and distally to the occlusion device (24, 142), preferably using an optical pressure sensor (28), an anchoring device (30, 54, 65, 80, 90A, 122) for anchoring the occlusion device (24, 142) in a predefined position in the coronary sinus (CS, 60), preferably in the ostium, the distal end (22) being deflectable/steerable with deflection being controlled by an actuator arranged at the proximal handle (10).

An integrated sheath assembly for inserting a medical device such as a percutaneous pump into a vessel can include a first sheath having a first lumen defining a first opening between proximal and distal ends of the first sheath for passage of a portion of the pump and a second sheath having a second lumen defining a second opening between proximal and distal ends of the second sheath. The second lumen is expandable to allow passage of the first sheath containing the portion of the pump. The first sheath fills a space between the second sheath and the portion of the percutaneous pump when the first sheath containing the percutaneous pump is inserted into the second lumen. The first sheath has a first hub, and the second sheath has a second hub. In some embodiments, a single sheath and a movable connector can be integrated on the medical device.

An integrated sheath assembly for inserting a medical device such as a percutaneous pump into a vessel can include a first sheath having a first lumen defining a first opening between proximal and distal ends of the first sheath for passage of a portion of the pump and a second sheath having a second lumen defining a second opening between proximal and distal ends of the second sheath. The second lumen is expandable to allow passage of the first sheath containing the portion of the pump. The first sheath fills a space between the second sheath and the portion of the percutaneous pump when the first sheath containing the percutaneous pump is inserted into the second lumen. The first sheath has a first hub, and the second sheath has a second hub. In some embodiments, a single sheath and a movable connector can be integrated on the medical device.