Abstract: A tunneling device for creating a pathway in subcutaneous tissue of a person's body. The tunneling device includes a member having two ends, where each of the ends defines an insertion surface that facilitates the insertion of the ends into the subcutaneous tissue of the person's body. The tunneling device includes an interchangeable handle connectable to each of the ends. The handle defines a grasping surface and an opening. The opening is configured to receive either of the ends. The grasping surface enables a user to securely hold the handle with one hand to forcibly move the member through the subcutaneous tissue of the person's body to create the pathway in the subcutaneous tissue, and pull a cable of an implant device through the created pathway.

Abstract: A tool for coring a hole in a portion of a patient's body. A cylindrical sheath includes a hollow bore open at both ends. A shaft is axially movable back and forth within the bore. A blade assembly is attached to one end of the shaft. The blade assembly comprises a hollow open cup portion having a closed end and a cutting edge formed around the margin of the open end. An interface is attached to the sheath which is shaped and dimensioned to communicate with a connector used to connect a medical device to a patient's body.

Abstract: A ventricular assist device incorporating a rotary pump, such as a rotary impeller pump is implantable in fluid communication with a ventricle and an artery to assist blood flow from the ventricle to the artery. The device includes a pump drive circuit supplying power to the pump, one or more sensors for sensing one or more electrophysiological signals such as electrogram signals in and a signal processing circuit connected to the sensors and the pump drive circuit. The signal processing circuit is operative to detect the sensor signals and control power supplied to the pump from the pump drive circuit so that the pump runs in a pulsatile mode, with a varying speed synchronized with the cardiac cycle. When an arrhythmia is detected, the pump drive circuit may also run the pump in an atrial arrhythmia mode or a ventricular arrhythmia mode different from the normal pulsatile mode.

Abstract: A cover for a percutaneous connector extending through the skin of a patient. The cover includes a structure having an inner side and an outer side. A first separable connector is mounted to the structure and disposed entirely within the structure, the first separable connector being configured to detachably engage and electrically connect with the percutaneous connector. A second separable connector is mounted to the structure and electrically connected to the first separable connector, the second separable connector being exposed at the outer side of the structure and being configured to detachably engage and electrically connect with an external device. The inner side of the structure defines a skin-engaging surface at least partially surrounding the first separable connector and the percutaneous connector, when the first separable connector is engaged with the percutaneous connector.

Abstract: A method of implanting a blood pump in a heart of a mammalian subject includes maintaining a temporary plug in an inlet opening of a pump having a pump body and an outlet cannula projecting from the pump body, advancing the pump into a ventricle of the heart through a hole in a wall of the heart so that the inlet of the pump is disposed within the ventricle and the outlet cannula extends through a valve of the heart into an artery, and then withdrawing the temporary plug from the inlet of the pump.

Abstract: An apparatus includes a tubular member defining a lumen and a channel, and a support member. The tubular member has a connection portion configured to be coupled to an organ wall. An outer edge of the connection portion is configured to contact a first portion of an inner surface of the wall when the connection portion is in an expanded configuration such that an interior volume of the organ is in fluid communication with the lumen. The support member is movably disposed within the channel and is configured to minimize movement of the wall relative to the tubular member. An end portion of the support member is disposed within the channel when the support member is in a first configuration. The end portion of the support member configured to contact a second portion of the inner surface of the wall when the support member is in a second configuration.

Abstract: A mounting element defining a bore, the mounting element being configured to mount to an exterior surface of an organ of a patient. A one way valve sized to be received and retained within the bore of the mounting element is included, the one way valve having an open position and a closed position. The one way valve substantially occludes the bore when the valve is in the closed position. The one way valve is biased in the closed position. A plug having a lumen extending there through is included, the plug being configured to be releasably inserted through at least a portion of the one way valve. The plug is configured to transition the one way valve from the closed position to the open position and to maintain the one way valve in the open position when the plug is inserted within the bore.

Abstract: A kit including a sheath having a tubular body with proximal and distal ends, an axis extending between the ends and a wall defining a bore extending along the axis to the distal end of the body. A delivery tube having proximal and distal ends and a lumen is adapted for disposition within the bore of the sheath in sealing engagement with the sheath, the delivery tube being slideable distally relative to the sheath. An elongated cannula having proximal and distal ends and a lumen is adapted for disposition inside the lumen of the delivery tube and an elongated dilator is adapted to fit within the lumen of the cannula with a proximal portion of the dilator extending proximally beyond the proximal ends of the cannula and delivery tube and in sealing engagement with the delivery tube proximal to the cannula.

Abstract: A tissue anchor includes an elongated body having a proximal end and a distal end, and a barb mounted to the elongated body adjacent the proximal end for movement between a retracted position and an extended position in which the barb projects outwardly from the elongated body. An anchoring system includes an implantable device with a tissue contacting surface facing in a proximal direction, the tissue anchor having its distal end engageable with the implantable device and its proximal end adapted to project proximally beyond the tissue contacting surface to grip a living tissue, and a second resilient element that is mounted between the distal end of the anchor and the implantable device, the second resilient element being adapted to bias the anchor distally relative to the implantable device. Tooling and methods of insertion and removal are provided.

Abstract: A connection system implantable within a living body having an exterior skin includes a male connector and a female connector. The male connector includes a shaft extending along an axis between a proximal end and a distal end, the shaft having an exterior surface surrounding the axis, at least one shaft contact carried on the shaft and exposed at the exterior surface, and a retaining element mounted to the shaft. The female connector includes a structure defining a bore extending along an axis between a proximal end and a distal end, at least one bore contact mounted to the structure and exposed within the bore and a catch element mounted to the structure. The catch and retaining elements allow the shaft to be inserted into the bore to align the contacts. A locking element rotatably locks the shaft in the bore. A method of implanting the system is also provided.

Abstract: A mounting ring for a ventricular assist device or other device used in the heart includes a plate adapted to be secured to the exterior of the heart by rigid anchors such as hook, pin, or screw. When hooks are used, they can be pivotally mounted to the plate so that the hooks can rotate from retracted positions to advanced positions. A tool can be included in a mounting ring kit to move the hooks from their retracted positions to their advanced positions so that the hooks secure the plate to the heart. Preferably, all of the hooks are advanced simultaneously. The VAD or other device is then secured to the plate. The plate can be mounted to the heart in less time than required to install a traditional mounting ring by suturing to the heart.

Abstract: A holder for a housing of an electronic device includes an extruded metal portion adapted to receive the housing and a securement element that is either mounted to the extruded metal portion or integral with the extruded metal portion. The securement element is adapted to secure the housing in the extruded metal portion.

Abstract: A ventricular assist system includes a ventricular assist device (“VAD”) and an expandable stent. The VAD may include a pump and an inlet element defining an inlet opening communicating with the pump, the inlet element being adapted for positioning with the inlet opening disposed within a ventricle of a heart when the system is in an operative condition. The expandable stent may be adapted for positioning within the ventricle when the system is in the operative condition. The pump may be operated to draw blood from the ventricle and return the blood to the artery, and a wall of the ventricle may be held away from the inlet opening with the stent. The stent may be passed through a channel in the ventricular assist device while the stent is in a collapsed condition.

Abstract: A hand-held apparatus for repairing a defect in an outer jacket of an elongated wire or cable includes a portable die and a source of a settable material. The die has a first portion connected by a hinge to a second portion. They cooperatively define a channel in a closed configuration. The source is connected to the channel through an opening between the inlet and outlet. A heating element is adapted to heat the settable material into a flowable condition and a control circuit is adapted to vary the supply of heat. The die is juxtaposed around the jacket near the defect. As the settable material is introduced into the channel, the wire or cable is moved along the channel relative to the die in the closed configuration such that a coating is formed over the defect. When the die is removed, the settable material sets into a solid condition.

Abstract: The present disclosure provides for methods and devices for determining the probability of a patient's aortic valve being open or closed. In one embodiment, a plurality of flow rate data points are obtained from a blood pump, a portion of the flow rate data points are identified, first and second index values characterizing properties of at least part of the identified portion of the flow rate data points determined using only arithmetic and/or exponentiation operations, and a probability is determined of whether the patient's aortic valve is open or closed based on the first and second index values.

Abstract: One aspect of an intravascular ventricular assist device is an implantable blood pump where the pump includes a housing defining a bore having an axis, one or more rotors disposed within the bore, each rotor including a plurality of magnetic poles, and one or more stators surrounding the bore for providing a magnetic field within the bore to induce rotation of each of the one or more rotors. Another aspect of the invention includes methods of providing cardiac assistance to a mammalian subject as, for example, a human. Further aspects of the invention include rotor bodies having helical channels formed longitudinally along the length of the body of the rotor where each helical channel is formed between peripheral support surface areas facing radially outwardly and extending generally in circumferential directions around the rotational axis of the rotor.

Abstract: An axial-flow blood pump for pumping blood includes a substantially cylindrical outer enclosure. A tubular housing concentric with and located within the outer enclosure has at one end an inlet and at an opposite end an outlet. A motor stator is concentric with and located between the outer enclosure and the tubular housing. An impeller is concentric with and located within the tubular housing. The impeller is suspended in operation by a combination of passive magnetic forces between magnets within the impeller or magnetized regions of the impeller and the motor stator and hydrodynamic thrust forces generated as blood flows between the tubular housing and a plurality of hydrodynamic thrust bearing surfaces located on the impeller. A volute may be in fluid-tight connection with the outlet of the tubular housing for receiving blood in the axial direction and directing blood in a direction normal to the axial direction.

Abstract: In one embodiment, the present invention includes a connector ring assembly to attach a VAD to a heart. The assembly includes a clamp which can rotate completely about the annular wall in a first state and is fixed relative to the annular wall in a second state. The clamp transitions from the first state to the second state via an actuator. The actuator can be configured with an axis of rotation generally parallel to the opening of the annular wall, thereby allowing manipulation of the actuator through the same surgical accessway as that used to implant the connector ring assembly. At least one embodiment provides a connector flange separately from an annular wall to provide greater access to the connector flange during implantation. The annular wall and clamp are attached to the connector flange after the flange is fixed to the heart.

Abstract: The present disclosure provides a system for oxygenating blood. The system may include an implantable blood pump that may draw a supply of blood from the circulatory system of a mammalian subject, such as a human being. The blood pump may provide the supply of blood to an adaptor, where the supply of blood may be supplied to either or both of a first branch or second branch. The first branch may lead to an external blood oxygenator. The oxygenator may oxygenate the blood, and the blood may be returned to the circulatory system of the mammalian subject. The second branch may bypass the oxygenator and may connect to the circulatory system of the mammalian subject. In this regard, while the blood is supplied to the second branch, the oxygenator may be disconnected and blood may be prevented from entering the first branch.

Abstract: A ventricular assist device incorporating a rotary pump (3) such as a rotary impeller pump implantable in fluid communication with a ventricle and an artery to assist blood flow from the ventricle to the artery. The device includes a pump drive circuit (6) supplying power to the pump, one or more sensors (10) for sensing one or more electrophysiological signals such as electrogram signals in and a signal processing circuit (23) connected to the sensors and to the pump drive circuit. The signal processing circuit is operative to detect the sensor signals and control power supplied to the pump from the pump drive circuit so that the pump runs in a normal sinus rhythm mode, with a varying speed synchronized with the cardiac cycle. When a bradycardia arrhythmia is detected, the pump drive circuit may also nm the pump in a sinus bradycardia mode or a heart block mode different from the normal sinus rhythm mode.