An access device for a heart chamber, a removable hemostatic valve unit, and a system and a method of creating a transapical passage on a beating heart are disclosed. In examples, the access device (1) includes an apical base plate (100) and a sealing unit (3) configured to provide a separation of a wet zone from a heart chamber and a dry zone with a gaseous environment outside of said heart chamber inside a patient body at the same time.

Percutaneous access devices (PAD) or other implantable medical devices formed with chain mail are provided. The use of chain mail allows for a flexible PAD that promotes the formation of natural biologic seals between the skin and the device to form a barrier to microbial invasion into the body. Percutaneous access devices may be used for cardiac assist systems, peritoneal dialysis catheters, Steinman pin, Kirschner wires, chronic indwelling venous access catheters that require skin penetration, and osseo-integrated percutaneous medical appliances. Unlike conventional chain mail that is only formed in two dimensional sheets, chain mail is formed in elongated linear chains with occasional interlinks, two dimensional sheets, and in other configurations and combinations including three dimensional structures, pendant petals, elongated linear chains, combined fractal structures having a non-integer dimensionality intermediate between 1 and 3, and combinations thereof. Chain mail may be formed of combinations of simpler structures to form higher-order structures.

Steering engagement catheter devices, systems, and methods of using the same for accessing a tissue, including internal and external tissues of a heart, are disclosed. In at least one embodiment, a steering engagement catheter is provided, comprising an elongated tube having a proximal end, a distal end, and a first wall positioned circumferentially along a length of the elongated tube, the elongated tube configured such that a delivery catheter is capable of at least partial insertion into the elongated tube, at least one steering wire having a proximal end and a distal end, the distal end of the at least one steering wire coupled to the first wall of the elongated tube at or near the distal end of the elongated tube, and a controller operably coupled to the at least one steering wire at or near the proximal end of the at least one steering wire.

The devices and method described herein allow for therapeutic damage to increase volume in these hyperdynamic hearts to allow improved physiology and ventricular filling and to reduce diastolic filling pressure by making the ventricle less stiff. For example, improving a diastolic heart function in a heart by creating at least one incision in cardiac muscle forming an interior heart wall of the interior chamber where the at least one incision extends into one or more layers of the interior heart wall without puncturing through the interior heart wall and the incision is sufficient to reduce a stiffness of the interior chamber to increase volume of the chamber and reduce diastolic filling pressure.

A mechanical circulatory support device. The mechanical circulatory support device includes an inner casing defining a fluid flow path, the fluid flow path defines a longitudinal axis. A rotor is mounted within the fluid flow path and configured to rotate about the longitudinal axis. A housing is included, the inner casing and the rotor being substantially disposed within the housing. The housing having a cross-sectional shape in a plane transverse to the longitudinal axis which decreases in thickness extending from a medial position to opposite lateral positions.

The invention comprises an apparatus and a method for operating a cardiac assist pump, comprising the steps of: (1) providing a cardiac monitor comprising: a cardiac output sensor including an activity sensor and at least two of: a pulse oximeter; an electrocardiogram meter; and a blood pressure monitor; (2) receiving time-varying cardiovascular input data, from the cardiac output sensor, related to a transient hemodynamic state of a cardiovascular system; (3) receiving and operating on time-varying activity input data, from the activity sensor, to generate cardiovascular state information; (4) sensing activity with the activity sensor to generate a target cardiovascular state; (5) repeating both the steps of receiving and operating to update the transient cardiovascular state information and the step of sensing to update the target cardiovascular state; and (6) directing the cardiac assist pump to adjust assisted blood flow, yielding the updated transient cardiovascular state, toward the target cardiovascular state.

The invention comprises an apparatus and a method for aiding function of a heart, comprising the steps of: (1) sensing a pulse; (2) providing a blood flow assist device, comprising: a first electroactive polymer sleeve segment circumferentially positioned about a portion of a first body part and a second electroactive polymer sleeve segment circumferentially positioned about a segment of a second body part; (3) sequentially constricting, timed to the pulse, the first electroactive polymer sleeve segment and the second electroactive polymer sleeve segment to aid the heart in circulation of blood; and (4) repeating the step of sensing the pulse and the step of constricting.

A device, a kit and a method are presented for permanently augmenting the pump function of the left heart. The basis for the presented innovation is an augmentation of the physiologically up and down movement of the mitral valve during each heart cycle. By means of catheter technique, minimal surgery, or open-heart surgery implants are inserted into the left ventricle, the mitral valve annulus, the left atrium and adjacent tissue in order to augment the natural up and down movement of the mitral valve and thereby increasing the left ventricular diastolic filling and the piston effect of the closed mitral valve when moving towards the apex of said heart in systole and/or away from said apex in diastole.

The present invention relates to an implantable heart help device for assisting the pump function of the heart by exerting an external force on the heart. The device is provided with a first fixating member adapted to be fixate the device to a part of the human body comprising bone, a heart pump device having a surface adapted to contact and exert an external force on the heart, a second fixating member in contact with the heart pump device. The second fixating member is displaceable in relation to the first fixating member for changing the position of the surface of the heart pump device, to allow the surface of the heart pump device to contact and exert the external force on at least two different positions on the heart.

The present invention relates to an implantable heart help device for assisting the pump function of the heart by exerting an external force on the heart. The device is provided with a first fixating member adapted to be fixate the device to a part of the human body comprising bone, a heart pump device having a surface adapted to contact and exert an external force on the heart, a second fixating member in contact with the heart pump device. The second fixating member is displaceable in relation to the first fixating member for changing the position of the surface of the heart pump device, to allow the surface of the heart pump device to contact and exert the external force on at least two different positions on the heart.