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 and method of drawing blood from the heart of a patient. The system includes a blood pump, an outflow cannula, and a flexible cannula assembly. The flexible cannula assembly includes a cannula body, a tip, and first and second anchors. The cannula body includes a proximal end coupled to the inlet of the blood pump, a distal end including a first locking element coupled to the tip. The first anchor has a first plurality of arms and is coupled to the tip and adapted to engage the internal surface of the heart wall. The second anchor includes a second plurality of arms and a second locking element and is slidably positioned on the outer wall of the cannula body and adapted to engage the first locking element of the distal end of the cannula body to couple the second anchor to the external surface of the heart wall.

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 kit for connecting a hollow cannula 40 to a hollow organ of a patient's body may include a sheath 70 having a tapered surface defined by a plurality of flaps at its distal end. A delivery tube 50 is slidably positioned within the sheath so that the sheath and delivery tube form a sealed enclosure that entirely contains the cannula. The enclosure and the cannula may be completely purged of air. An elongated dilator 10 may project through the sealed assembly in slideable engagement with the sheath and delivery tube. After advancing the liquid-filled enclosure into the organ, the distal end of the sheath is opened by advancing the delivery tube, and the cannula is advanced until an anchor 48 at the distal end of the cannula exits the delivery tube inside the organ and opens to anchor the cannula in place.

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 cannula for moving fluids between a pump and the circulatory system of a patient. The cannula includes a liner having an intermediate portion between a proximal portion and a distal portion, and a lumen extending between the proximal and distal portions. At least the intermediate portion of the liner is constructed from a tissue in-growth material for supporting the growth of endothelial cells. A jacket surrounds at least part of the liner.

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 transseptal cannula having a flexible cannula body, a left atrial anchor coupled to the distal end of the flexible cannula body, and a right atrial anchor operable to be attached to the left atrial anchor in vivo. The left and right atrial anchors are implanted and deployed separately. Delivery of the transseptal cannula to a heart tissue can include a low profile coaxial balloon catheter comprising a tube body including an inner member and an outer member surrounding the inner member and thereby creating an inflation channel between the inner and outer members, a hub coupled to the proximal portion of the tube body and including a fluid space in fluid communication with the inflation channel; and a balloon coupled to the distal portion of the tube body, wherein the balloon is in fluid communication with the inflation channel.

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 stent is made or a material so that the stent collapses upon deflation of the balloon.

Abstract: A malleable cannula for fluidically coupling with an anatomical structure includes a flexible cannula body wall having a proximal end, a distal end, and a lumen extending longitudinally between the proximal end and the distal end. The proximal end defines a first opening to the lumen and the distal end defining a second opening to the lumen. A channel is defined by a portion of the cannula body wall and extends longitudinally from the distal end toward the proximal end. The channel has a first end oriented toward the proximal end of the cannula body wall. A malleable member is provided within the channel and is fixedly connected to the cannula body wall at the first end of the channel. The malleable member is configured to assume and maintain a formed shape of the cannula body wall.

Abstract: A cannula assembly, further comprising a cannula body for directing blood from the heart of a patient, having distal and proximal ends and a lumen therebetween. A tip coupled to the distal end of the body, the tip having an opening. A pump for drawing blood into the cannula assembly and dispensing the blood from the cannula assembly and into the patient circulatory system. The lumen of the cannula body further comprises a first inner diameter at the proximal end and a second inner diameter at the distal end, the first inner diameter being larger than the second inner diameter. A tapered portion defined as a decrease in inner diameter from the first inner diameter to the second inner diameter between the proximal and distal ends, the tapered portion configured to prevent cavitation of the blood within the cannula.

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 cannula for insertion through a biologic tissue. The cannula includes a shaft having proximal and distal end portions with a lumen therebetween. The cannula further includes a tip having a proximal end portion, a distal tip end, and a lumen therebetween. The proximal end portion of the tip is secured to the distal end portion of the shaft so that the lumen of the tip is in fluid communication with the lumen of the shaft. The tip includes an opening that extends proximally relative to the distal tip end to permit the flow of fluid into the lumen of the tip even in the event that the distal tip end becomes obstructed.

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 cannula assembly, further comprising a cannula body for directing blood from the heart of a patient, having distal and proximal ends and a lumen therebetween. A tip coupled to the distal end of the body, the tip having an opening. A pump for drawing blood into the cannula assembly and dispensing the blood from the cannula assembly and into the patient circulatory system. The lumen of the cannula body further comprises a first inner diameter at the proximal end and a second inner diameter at the distal end, the first inner diameter being larger than the second inner diameter. A tapered portion defined as a decrease in inner diameter from the first inner diameter to the second inner diameter between the proximal and distal ends, the tapered portion configured to prevent cavitation of the blood within the cannula.

Abstract: A transseptal cannula having a flexible cannula body, a left atrial anchor coupled to the distal end of the flexible cannula body, and a right atrial anchor operable to be attached to the left atrial anchor in vivo. The left and right atrial anchors are implanted and deployed separately. Delivery of the transseptal cannula to a heart tissue can include a low profile coaxial balloon catheter comprising a tube body including an inner member and an outer member surrounding the inner member and thereby creating an inflation channel between the inner and outer members, a hub coupled to the proximal portion of the tube body and including a fluid space in fluid communication with the inflation channel; and a balloon coupled to the distal portion of the tube body, wherein the balloon is in fluid communication with the inflation channel.

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 bifurcated cannula for directing blood into the arterial system. The bifurcated cannula including an ingress channel and first and second egress channels. The first egress channel directs a first portion of the blood entering the bifurcated cannula into the arterial system in a first direction. The second egress channel directs a second portion of the blood entering the bifurcated cannula into the arterial system in a direction that opposes the first direction.

Abstract: A transseptal cannula having a flexible cannula body, a left atrial anchor coupled to the distal end of the flexible cannula body, and a right atrial anchor operable to be attached to the left atrial anchor in vivo. The left and right atrial anchors are implanted and deployed separately. Delivery of the transseptal cannula to a heart tissue can include a low profile coaxial balloon catheter comprising a tube body including an inner member and an outer member surrounding the inner member and thereby creating an inflation channel between the inner and outer members, a hub coupled to the proximal portion of the tube body and including a fluid space in fluid communication with the inflation channel; and a balloon coupled to the distal portion of the tube body, wherein the balloon is in fluid communication with the inflation channel.

Abstract: A cannula assembly, further comprising a cannula body for directing blood from the heart of a patient, having distal and proximal ends and a lumen therebetween. A tip coupled to the distal end of the body, the tip having an opening. A pump for drawing blood into the cannula assembly and dispensing the blood from the cannula assembly and into the patient circulatory system. The lumen of the cannula body further comprises a first inner diameter at the proximal end and a second inner diameter at the distal end, the first inner diameter being larger than the second inner diameter. A tapered portion defined as a decrease in inner diameter from the first inner diameter to the second inner diameter between the proximal and distal ends, the tapered portion configured to prevent cavitation of the blood within the cannula.