In some variations, a circulatory assist system may include a pump body comprising a conduit having an inflow region and an outflow region, and a volume displacement member arranged in the conduit and operable between an expansion phase and a contraction phase. The circulatory assist system may also include an inlet valve arranged in the inflow region and comprising a plurality of leaflets. The inlet valve may receive blood into the conduit and the pump body may convey the received blood through the outflow region via cyclical operation of the volume displacement member between the expansion phase and the contraction phase. In some variations, the inlet valve may operate between open and closed states at high frequencies while withstanding a high pressure differential when the circulatory assist system is in use.
A61M 60/13 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable via, into, inside, in line, branching on, or around a blood vessel by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
A61M 60/135 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting
A61M 60/139 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting inside the aorta, e.g. intra-aortic balloon pumps
A61M 60/268 - Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
A61M 60/295 - Balloon pumps for circulatory assistance
A61M 60/497 - Details relating to driving for balloon pumps for circulatory assistance
A61M 60/843 - Balloon aspects, e.g. shapes or materials
Circulatory assist devices and methods are disclosed herein. In some variations, a circulatory assist system may be configured for placement in a cardiovascular lumen (e.g., aorta) and include a pump arrangement comprising a pump region configured to receive blood, an outflow region, and a pump in the pump region and configured to drive the received blood toward the outflow region. The circulatory assist system may further include a vascular seal configured to form a peripheral seal between the pump arrangement and an inner wall of the cardiovascular lumen.
A61M 60/13 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable via, into, inside, in line, branching on, or around a blood vessel by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
A61M 60/135 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting
A61M 60/139 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting inside the aorta, e.g. intra-aortic balloon pumps
A61M 60/216 - Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
A61M 60/295 - Balloon pumps for circulatory assistance
A61M 60/33 - Medical purposes thereof other than the enhancement of the cardiac output for enhancement of in vivo organ perfusion, e.g. retroperfusion of kidneys
In some variations, a medical device may include an expandable support with an interior region and a seal arranged within the interior region of the expandable support. The expandable support may have a delivery configuration with a first diameter and a deployment configuration with a second diameter larger than the first diameter. The seal may include a seal opening and a sealing element configured to seal around a circulatory assist device seated in the seal opening. In some variations, the medical device may be delivered to a treatment site in a cardiovascular lumen (e.g., descending aorta) of a patient, and the circulatory assist device may be operated while positioned in the seal opening to provide circulatory support to the patient.
A61M 60/13 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable via, into, inside, in line, branching on, or around a blood vessel by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
A61M 60/237 - Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller the blood flow through the rotating member having mainly axial components, e.g. axial flow pumps
A61M 60/268 - Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
Circulatory assist systems, devices, and methods are disclosed herein. In some variations, a circulatory assist system may include a pump body including a conduit having a longitudinal flow axis extending between the inlet and the outlet and a volume displacement member arranged in the conduit and operable in an expansion phase and a contraction phase. The circulatory assist system may also include an inlet valve configured to receive a fluid along the flow axis. The pump body may be configured to convey the received fluid through the outlet during both the expansion phase and the contraction phase, such as at least partially due to sustained momentum of fluid during at least a portion of the expansion phase and at least a portion of the contraction phase.
A61M 60/135 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting
A61M 60/165 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable in, on, or around the heart
A61M 60/268 - Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
A61M 60/295 - Balloon pumps for circulatory assistance
A61M 60/427 - Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being hydraulic or pneumatic
A61M 60/497 - Details relating to driving for balloon pumps for circulatory assistance
5.
INLET VALVES FOR A CARDIAC ASSIST DEVICE AND RELATED TECHNOLOGY
A cardiac assist device includes a cup having a cup wall defining an inner cup volume, and an outflow element having an aperture for expelling a fluid during operation. A balloon has a balloon wall positioned inside the cup. A lumen is present for inflating and deflating the balloon during operation, creating a pumping operational mode and a filling operational mode, respectively. One or more one-way valves are arranged in the cup wall to allow the fluid to flow into the cup during the filling operational mode. One or more of the one-way valves comprise apertures and flaps arranged to close off the apertures during the pumping operational mode.
A61M 60/139 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting inside the aorta, e.g. intra-aortic balloon pumps
A61M 60/295 - Balloon pumps for circulatory assistance
A61M 60/497 - Details relating to driving for balloon pumps for circulatory assistance
A cardiac assist device includes an expandable cup with a pumping chamber having at least one inflow aperture, an outflow nozzle in communication with the chamber, and a volume displacement member inside the chamber. The volume displacement member is cyclically movable between a low-volume state and a high-volume state at a frequency F, wherein a displacement volume of blood Vd is displaced from the chamber through the nozzle during each cycle. When the volume displacement member moves at frequency F, the device increases momentum of blood flowing through the device such that flow rate of blood exiting the nozzle is substantially greater than the frequency F multiplied by the displacement volume Vd. In some embodiments, the volume displacement member includes a balloon having a proximal region that is distanced from an inner wall of the chamber more than a distal region of the balloon when the balloon is fully inflated.
A61M 60/17 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps
A61M 60/268 - Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
A61M 60/295 - Balloon pumps for circulatory assistance
A61M 60/427 - Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being hydraulic or pneumatic
A61M 60/497 - Details relating to driving for balloon pumps for circulatory assistance
A61M 60/837 - Aspects of flexible displacement members, e.g. shapes or materials
A61M 60/896 - Passive valves, i.e. valves actuated by the blood having flexible or resilient parts, e.g. flap valves
A61M 60/898 - Valves the blood pump being a membrane blood pump and the membrane acting as inlet valve
A61M 60/174 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps discharging the blood to the ventricle or arterial system via a cannula internal to the ventricle or arterial system
7.
Cardiac assist device with high frequency operation
A cardiac assist device with an expandable cup (4) having a transport state and an operational state, the expandable cup comprising a plurality of inflow apertures (5), and an outflow nozzle (6), and an inflatable balloon (8) positioned inside the expandable cup (4). A catheter assembly (3) is connected to the inflatable balloon (8) during operation, and a control unit (2) is connected to the catheter assembly (3). The control unit (2) is arranged to operate the inflatable balloon (8) with a frequency of more than 100 beats per minute.
A61M 60/139 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting inside the aorta, e.g. intra-aortic balloon pumps
A61M 60/295 - Balloon pumps for circulatory assistance
A61M 60/427 - Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being hydraulic or pneumatic
A cardiac assist device includes a cup having a cup wall defining an inner cup volume, and an outflow element having an aperture for expelling a fluid during operation. A balloon has a balloon wall positioned inside the cup. A lumen is present for inflating and deflating the balloon during operation, creating a pumping operational mode and a filling operational mode, respectively. One or more one-way valves are arranged in the cup wall to allow the fluid to flow into the cup during the filling operational mode. One or more of the one-way valves comprise apertures and flaps arranged to close off the apertures during the pumping operational mode.
A61M 60/17 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps
A61M 60/268 - Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
A61M 60/295 - Balloon pumps for circulatory assistance
A61M 60/174 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps discharging the blood to the ventricle or arterial system via a cannula internal to the ventricle or arterial system
A61M 60/427 - Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being hydraulic or pneumatic
A cardiac assist device (1) with a cup element (2), an inner balloon element (5) and a tube element (6). The cup element (2) has a cup wall (2a), one or more in-flow openings (3), and an outflow element (4 having an aperture (4a). The inner balloon element (5) is positioned inside the cup element (2) free from the outflow element (4). The tube element (6) is arranged for inflating and deflating the inner balloon element (5) during operation. During operation in a pumping operational mode, the combination of first material, dimensions of the cup wall (2a), and dimensions of the outflow element (4) provides a containment force by the cup element (2) counteracting an outward directed force of the inner balloon element (5).
A61M 60/174 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps discharging the blood to the ventricle or arterial system via a cannula internal to the ventricle or arterial system
A61M 60/295 - Balloon pumps for circulatory assistance
A61M 60/515 - Regulation using real-time patient data
10.
CARDIAC ASSIST DEVICE WITH HIGH FREQUENCY OPERATION
A cardiac assist device with an expandable cup (4) having a transport state and an operational state, the expandable cup comprising a plurality of inflow apertures (5), and an outflow nozzle (6), and an inflatable balloon (8) positioned inside the expandable cup (4). A catheter assembly (3) is connected to the inflatable balloon (8) during operation, and a control unit (2) is connected to the catheter assembly (3). The control unit (2) is arranged to operate the inflatable balloon (8) with a frequency of more than 100 beats per minute.
A61M 60/13 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable via, into, inside, in line, branching on, or around a blood vessel by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
A61M 60/139 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting inside the aorta, e.g. intra-aortic balloon pumps
A61M 60/17 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps
A61M 60/268 - Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
A61M 60/295 - Balloon pumps for circulatory assistance
A61M 60/427 - Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being hydraulic or pneumatic
A cardiac assist device with an expandable cup (4) having a transport state and an operational state, the expandable cup comprising a plurality of inflow apertures (5), and an outflow nozzle (6), and an inflatable balloon (8) positioned inside the expandable cup (4). A catheter assembly (3) is connected to the inflatable balloon (8) during operation, and a control unit (2) is connected to the catheter assembly (3). The control unit (2) is arranged to operate the inflatable balloon (8) with a frequency of more than 100 beats per minute.
A61M 60/13 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable via, into, inside, in line, branching on, or around a blood vessel by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
A61M 60/139 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting inside the aorta, e.g. intra-aortic balloon pumps
A61M 60/17 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps
A61M 60/268 - Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
A61M 60/295 - Balloon pumps for circulatory assistance
A61M 60/427 - Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being hydraulic or pneumatic
A heart support device for circulatory assistance is disclosed. The device comprises a chamber body defining a chamber having an internal volume configured to be filled with blood. The chamber body has a first opening and the chamber is dimensioned such that the first opening and the chamber are fully disposed within a chamber of the human heart. A dynamic volume body is provided and configured to be inflated or deflated to alternately increase or decrease the interior volume of the chamber. A catheter comprising at least one lumen in fluid communication with the dynamic volume body is configured to deliver fluid to the dynamic volume body to inflate the dynamic volume body. A directional flow structure is configured to direct a flow of blood out of the chamber in a direction substantially aligned with a direction in which the catheter extends.
A61M 60/148 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable via, into, inside, in line, branching on, or around a blood vessel in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
A61M 60/268 - Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
A61M 60/17 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps
A device (2) for providing circulatory assistance is provided and comprises a balloon (4) comprising a membrane defining a cavity having an internal volume (Vc), wherein the balloon comprises a proximal portion (4a) comprising a proximal end and a distal portion (4b) comprising a distal end. The device (2) further comprises a first catheter, affixed to the distal end of the balloon (4) at a first fixation point (P1) and a second catheter (8), affixed to the proximal end of the balloon at a second fixation point (P2). The second catheter (8) is configured for axial movement with respect to the first catheter or guide wire (6) between a first position in which the first and second fixation points (P1, P2) are spaced apart from each other in the longitudinal direction by a first distance (Dx), which is variable to bring about inversion of the balloon.
A61M 60/17 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps
A61M 60/268 - Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
A61M 60/427 - Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being hydraulic or pneumatic
A61M 60/865 - Devices for guiding or inserting pumps or pumping devices into the patient’s body
A heart support device for circulatory assistance is disclosed. The device (2) comprises a chamber body (4) comprising an outer wall and defining an internal volume (Vx) configured to receive a volume of fluid. The chamber body (4) comprises an outlet opening (8) at its proximal end (4a), the outlet opening (8) being in fluid communication with an exterior volume in which the chamber body (4) is disposed. The outer wall of the chamber body (4) is configured to alternately collapse and expand between a first configuration in which the internal volume Vx=V1 and a second configuration in which the internal volume Vx=V2, wherein Vi is larger than V2, and thereby pump the fluid through the outlet opening (8). The cross-sectional internal diameter of the outlet opening (8) is less than a maximum cross-sectional internal diameter of the chamber body (4).
A61M 60/148 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable via, into, inside, in line, branching on, or around a blood vessel in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
A61M 60/268 - Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
A61M 60/17 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps
A cardiac assist device (1) with a cup element (2), an inner balloon element (5) and a tube element (6). The cup element (2) has a cup wall (2a), one or more in-flow openings (3), and an outflow element (4 having an aperture (4a). The inner balloon element (5) is positioned inside the cup element (2) free from the outflow element (4). The tube element (6) is arranged for inflating and deflating the inner balloon element (5) during operation. During operation in a pumping operational mode, the combination of first material, dimensions of the cup wall (2a), and dimensions of the outflow element (4) provides a containment force by the cup element (2) counteracting an outward directed force of the inner balloon element (5).
A61M 60/174 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps discharging the blood to the ventricle or arterial system via a cannula internal to the ventricle or arterial system
A61M 60/295 - Balloon pumps for circulatory assistance
A61M 60/497 - Details relating to driving for balloon pumps for circulatory assistance
A61M 60/515 - Regulation using real-time patient data
A61M 60/843 - Balloon aspects, e.g. shapes or materials
A61M 60/898 - Valves the blood pump being a membrane blood pump and the membrane acting as inlet valve
A61M 60/268 - Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
A61M 60/427 - Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being hydraulic or pneumatic
A61M 60/837 - Aspects of flexible displacement members, e.g. shapes or materials
A61M 60/896 - Passive valves, i.e. valves actuated by the blood having flexible or resilient parts, e.g. flap valves
A heart support device for circulatory assistance is disclosed. The device comprises a chamber body (10) defining a chamber having an internal volume configured to be filled with blood. The chamber body (10) has a first opening (12) and the chamber is dimensioned such that the first opening (12) and the chamber are fully disposed within a chamber of the human heart. A dynamic volume body (14) is provided and configured to be inflated or deflated to alternately increase or decrease the interior volume of the chamber. A catheter (16) comprising at least one lumen in fluid communication with the dynamic volume body is configured to deliver fluid to the dynamic volume body to inflate the dynamic volume body. A directional flow structure is configured to direct a flow of blood out of the chamber in a direction substantially aligned with a direction in which the catheter (16) extends.
A61M 60/17 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps
A61M 60/148 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable via, into, inside, in line, branching on, or around a blood vessel in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
A61M 60/268 - Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
A61M 60/497 - Details relating to driving for balloon pumps for circulatory assistance
A61M 60/812 - Vanes or blades, e.g. static flow guides
x1x2122, and thereby pump the fluid through the outlet opening (8). The cross-sectional internal diameter of the outlet opening (8) is less than a maximum 10 cross-sectional internal diameter of the chamber body (4).
A stented valve suitable for use in body ducts. The valve includes an expandable support structure and an attached flexible membrane that changes shape when the valve opens and closes. The expandable support structure has the shape of a stent with a series of interconnected expandable unit cells and elongated support beams. When the valve is open, body fluid can flow around the membrane and pass through the gap between it and the inner stent surface. In one configuration, a set of two valves is combined with an intermediate inflatable balloon to create a cardiac assist pumping device. In another embodiment, valve closure can be achieved by remotely controlled valve leaflets actuation. A double aorta valve frame is used to accommodate shape and diameter variations of the annulus in an outer valve frame, while the inner valve frame has dimensions for optimized performance of the valve membrane.