Abstract: A steerable catheter, such as a dilator, includes an elongated shaft including a proximal end portion and a distal end portion, an end effector disposed at the distal end portion of the shaft, and a handle disposed at the proximal end portion of the shaft. The end effector includes a dilation portion disposed proximate the distal end portion of the shaft, a transition portion disposed distally on the dilation portion, and a distal tip portion disposed distally on the transition portion. The tip portion is movable relative to the dilation portion. The handle includes a tip portion steering actuator enabling a user to steer the tip portion. The tip portion has a tip portion diameter. The dilation portion has a dilation portion diameter which is greater than the tip portion diameter. The transition portion tapers from the tip portion diameter to the dilation portion diameter.

Abstract: A head stabilization system including a head restraint mechanism and a head harness configured to engage a head of a patient. The head restraint mechanism is configured to be operatively disposed on a patient support device and includes a generally vertically upstanding arcuate tilt guide. The head harness is releasably attachable to and at least partially supported by the head restraint mechanism. The head harness is selectively repositionable generally vertically relative to the tilt guide. The head restraint mechanism is configured to stabilize the head harness relative to the patient support device. The head restraint mechanism is configured to selectively allow lateral flexion of a neck of the patient, lateral rotation of the head of the patient, and extension and flexion of the neck of the patient.

Abstract: An angioplasty balloon including a non-deployable stent to prevent or reduce the potential for slippage of the inflated balloon with respect to the vessel wall being treated. The balloon includes a non-deployable stent that is adapted to be secured to the balloon or angioplasty balloon catheter. The stent has a proximal end, a distal end, and at least three radially-spaced struts, each, each strut connecting the proximal end to the distal end and having one or more bends that allow expansion of the strut to accommodate the inflation of the balloon. The stem is made or a material so that the stent collapses upon deflation of the balloon.

Abstract: A device for sealing an opening through a biologic tissue membrane against leakage. The device includes an implantable fluid sealing plug including a structural hydrogel. The fluid sealing plug is configured to be positioned at least partially within the opening through a biologic tissue such as a membrane. The fluid sealing plug is configured to increase in diameter upon absorbing a fluid, and the increase in diameter of the fluid sealing plug upon absorbing the fluid seals the opening through a biologic tissue membrane.

Abstract: An implantable closure device for sealing an opening through a biologic tissue membrane against leakage of biological fluid includes a fluid sealing plug configured to be positioned within the opening. One or more retainer sections are configured to secure the fluid sealing plug within the opening. The retainer sections include at least one of a distal retainer section coupled to a distal end of the fluid sealing plug and configured to be disposed distally on the biologic tissue membrane, or a proximal retainer section coupled to a proximal end of the fluid sealing plug and configured to be disposed proximally on the biologic tissue membrane.

Abstract: An implantable closure device for sealing an opening, such as a puncture, through a biologic tissue membrane, such as the meninges, against leakage of biological fluid. The closure device includes a fluid sealing plug configured to be positioned at least partially within the opening through the biologic tissue membrane. A retainer is configured to secure the fluid sealing plug at least partially within the opening. The retainer includes a proximal retainer portion configured to be disposed proximally on the biologic tissue membrane, a distal retainer portion configured to be disposed distally on the biologic tissue membrane, and a central retainer portion connecting the proximal retainer portion and the distal retainer portion. The central retainer portion is configured to extend through the opening. The fluid sealing plug is coupled to the central retainer portion.

Abstract: A control circuit includes a pump shutdown module responsive to one or more inputs indicating at least from the group consisting of an operational error at the implantable blood pump and an adverse physiological state of a user of the implantable blood pump. The pump shutdown module ceases operation of the implantable blood pump in response to the one or more inputs. A pump restart module configured to resume operation of the implantable blood pump in response to a first pump restart input and a second pump restart input is included. A pump restart lockout module configured to initiate a pump lockout mode in response to a lockout input is included. The pump lockout mode prevents resumption of operation of the implantable blood pump in response to the first pump restart input and allows resumption of operation of the implantable blood pump in response to the second pump restart input.

Abstract: An endovascular anastomotic connector and method of using the same. The endovascular anastomotic connector includes a vascular conduit and a supply conduit. The vascular conduit has proximal and distal ends that reside within a vascular structure. The supply conduit extends at an angle from the vascular conduit. The proximal end of the supply conduit is configured to be attached to an auxiliary device.

Abstract: A control circuit includes a pump shutdown module responsive to one or more inputs indicating at least from the group consisting of an operational error at the implantable blood pump and an adverse physiological state of a user of the implantable blood pump. The pump shutdown module ceases operation of the implantable blood pump in response to the one or more inputs. A pump restart module configured to resume operation of the implantable blood pump in response to a first pump restart input and a second pump restart input is included. A pump restart lockout module configured to initiate a pump lockout mode in response to a lockout input is included. The pump lockout mode prevents resumption of operation of the implantable blood pump in response to the first pump restart input and allows resumption of operation of the implantable blood pump in response to the second pump restart input.

Abstract: A system for drawing blood from a heart of a patient, includes a blood pump, an outflow cannula and a flexible cannula assembly. The cannula assembly further includes a flexible cannula body including a proximal end, a distal end, an inner wall defining a lumen, and an outer wall. A tip is coupled with the distal end of the cannula body, and an anchor is coupled to the tip. The anchor is configured to engage an internal structure of the heart and resists movement of the cannula assembly in at least one direction along the flexible cannula body. A ring member is configured to be coupled to the heart wall and is positioned at least partially around the outer wall of the cannula body proximally relative to the tip. The ring member is further configured to provide hemostasis between the heart wall and the cannula body.

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 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 system for facilitating fluid connection between cannulae and a blood pump. The system includes a cannula having a distal end adapted to be in fluid communication with the circulatory system and a proximal end configured to couple to an inlet of the blood pump. Further included is a tunneling device configured to be inserted into a body of a patient to direct the proximal end of the cannula adjacent to the inlet and including a second connecting structure. Further included is a plug which has a first plug part and a second plug part. The first plug part includes a second connecting structure, the first and second connecting structures being selectively engageable. The second plug part is configured to be inserted in the proximal end of the cannula. The first and second plug parts are selectively disengageable to allow in situ disconnection between the cannula and tunneling device.

Abstract: A malleable cannula. The malleable cannula includes a polymeric jacket and a malleable member. The malleable member, being surrounded by the jacket, includes a proximal end, a distal end, and a lumen extending therebetween and along a lengthwise axis of the malleable cannula. The malleable member further includes a longitudinal strut that is parallel to the lengthwise axis and a plurality of transverse struts coupled to and extending laterally away from the longitudinal strut and at least a portion of the lumen. The malleable member is configured to assume and maintain a shape of the malleable cannula.

Abstract: A blood circulation assist system comprising an inflow cannula having a lumen and an insertion device configured to be received therein and to facilitate insertion of a portion of the inflow cannula into a heart chamber. The insertion device includes a shaft having distal and proximal end portions and a plurality of lumens. A first lumen is configured to receive a guidewire and a second lumen is configured to receive a pressurized fluid. A tip connected to the distal end portion of the shaft is configured for insertion into the heart chamber. The tip has a hollow interior communicating with the first shaft lumen. An inflatable member is coupled to the distal end portion of the shaft and includes a hollow interior in fluid communication with the second shaft lumen. The inflatable member is movable between deflated and inflated configurations for releasably securing the insertion device to the inflow cannula.

Abstract: A control circuit includes a pump shutdown module responsive to one or more inputs indicating at least from the group consisting of an operational error at the implantable blood pump and an adverse physiological state of a user of the implantable blood pump. The pump shutdown module ceases operation of the implantable blood pump in response to the one or more inputs. A pump restart module configured to resume operation of the implantable blood pump in response to a first pump restart input and a second pump restart input is included. A pump restart lockout module configured to initiate a pump lockout mode in response to a lockout input is included. The pump lockout mode prevents resumption of operation of the implantable blood pump in response to the first pump restart input and allows resumption of operation of the implantable blood pump in response to the second pump restart input.

Abstract: A system for facilitating fluid connection between cannulae and a blood pump. The system includes a cannula having proximal and distal ends. The distal end of the cannula adapted to be in fluid communication with the circulatory system. The proximal end of the cannula configured to couple to an inlet of the blood pump. The system further includes a tunneling device configured to be inserted into a body of a patient to direct the proximal end of the cannula adjacent to the inlet for connection thereto. The cannula further includes a first connecting structure. The tunneling device further includes a second connecting structure. The first and second connecting structures are selectively engageable to allow connection and disconnection between the cannula and tunneling device.

Abstract: A control circuit includes a pump shutdown module responsive to one or more inputs indicating at least from the group consisting of an operational error at the implantable blood pump and an adverse physiological state of a user of the implantable blood pump. The pump shutdown module ceases operation of the implantable blood pump in response to the one or more inputs. A pump restart module configured to resume operation of the implantable blood pump in response to a first pump restart input and a second pump restart input is included. A pump restart lockout module configured to initiate a pump lockout mode in response to a lockout input is included. The pump lockout mode prevents resumption of operation of the implantable blood pump in response to the first pump restart input and allows resumption of operation of the implantable blood pump in response to the second pump restart input.

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 cannula assembly for directing blood from the heart of a patient and a minimally invasive method of implanting the same. The cannula assembly includes a flexible cannula body having a proximal end and a distal end with a receiving portion, and a transseptal tip having a distal end and a proximal end with an engaging portion. First and second anchors are coupled to the transseptal tip and configured to be deployed from a contracted state to an expanded state. The engaging portion of the transseptal tip is operable to removably engage the receiving portion of the flexible cannula body in vivo.