A pneumatic cardiac assist device (PCAD) leak detection apparatus and method is described. The embodiments offer efficient and effective detection of leaks in PCADs, including but not limited to counterpulsation devices. A leak is detected based on measured pressures and temperatures at a first time and at a second time and further while accounting for a change in PCAD system pressure that is attributable to the change in temperature over the period of time. The PCAD system may be controlled by the leak detection.
Intravascularly delivered blood pumps and associated devices, systems, and methods, are disclosed herein. A method of intravascularly delivering a blood pump in accordance with embodiments of the present technology can include, for example, advancing an elongated delivery dilator through a patient's vasculature such that a first portion of the elongated delivery dilator is externally accessible proximate to the subclavian artery and a second portion of the elongated delivery dilator is externally accessible proximate to the femoral artery. The method can further include attaching the second portion of the elongated delivery dilator to a driveline, which is coupled to a balloon at the opposite end, and then pulling on the first portion of the elongated delivery dilator to move the driveline and the balloon through the patient's vasculature to a target site with the balloon positioned within the aorta.
A61M 39/06 - Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
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 60/178 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
A drive unit system for operating a cardiac assist device is disclosed. The drive unit system may include an R-wave detection module that makes a speculative detection of an R-wave associated with a received electrocardiogram (ECG) signal of a patient's heart and a conservative detection of the R-wave. The drive unit system includes a drive unit that may be coupled to the cardiac assist device and may operate the cardiac assist device based on the speculative detection and the conservative detection.
A61M 60/161 - 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 mechanically acting upon the outside of the patient’s blood vessel structure, e.g. compressive structures placed around a vessel
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
4.
SYSTEM AND METHOD FOR PREVENTING GAS LEAKAGE FROM AN INTRA-AORTIC BALLOON
A system for limiting inflation of an expandable member (e.g., a balloon) in an intravascular circulatory support system of a patient may comprise a drive unit and an air mover limiter. The drive unit may include an air mover and a motor. The air mover may have a first end and a second end. The first end may be fixed and have a pneumatic output in fluid connection with the expandable member. The second end may be movable and pneumatically closed. The air mover limiter may be configured to restrict displacement of the second end to under-inflate the expandable member based on the blood pressure of the patient. Displacement of the second end moves a volume of air into or out of the expandable member. The volume of air corresponds to the air mover limiter configuration.
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
A61M 60/531 - Regulation using real-time patient data using blood pressure data, e.g. from blood pressure sensors
A blood pump assembly comprises a balloon defining an elongated inflatable chamber with an opening at the proximal end. The proximal region of the balloon is substantially cylindro-conically shaped, and tapering toward the proximal end of the balloon, the central region of the balloon is substantially cylindrically shaped with a substantially uniform exterior diameter. The distal region of the balloon is substantially cylindro-conically shaped, the distal region of the balloon tapering toward the distal end of the balloon. The length of the distal region of the balloon is greater than approximately 15% of the combined length of the proximal and central regions of the balloon. A driveline may be coupleable to the opening and have a connection element disposed at a proximal end of the driveline. A radio opaque marker may be integrated into the driveline at a distal end of the driveline.
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 60/289 - Devices for mechanical circulatory actuation assisting the residual heart function by means mechanically acting upon the patient's native heart or blood vessel structure, e.g. direct cardiac compression [DCC] devices
A61M 60/497 - Details relating to driving for balloon pumps for circulatory assistance
A61M 60/841 - Constructional details other than related to driving of balloon pumps for circulatory assistance
A61M 60/843 - Balloon aspects, e.g. shapes or materials
6.
BLOOD PUMP SUPPORT APPARATUS AND METHOD FOR A BLOOD PUMP ASSEMBLY
A blood pump assembly has a balloon disposed at a distal region and a driveline disposed at a proximal region and is capable of being employed to provide mechanical circulatory support (e.g., counterpulsation). A blood pump support apparatus has a support structure with a head region and a tail region that is removably disposable in the blood pump assembly. When the support structure is disposed in the blood pump assembly, the head region is disposed within the balloon. When the blood pump assembly is implanted in the descending aorta and the support structure is disposed in the blood pump assembly, forces act on the balloon that would cause the balloon to roll or fold upon itself along an angle with respect to the balloon's longitudinal axis. The head region of support structure opposes these forces.
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 blood pump assembly comprises a balloon defining an elongated inflatable chamber with an opening at the proximal end. The proximal region of the balloon is substantially cylindro-conically shaped, and tapering toward the proximal end of the balloon, the central region of the balloon is substantially cylindrically shaped with a substantially uniform exterior diameter. The distal region of the balloon is substantially cylindro-conically shaped, the distal region of the balloon tapering toward the distal end of the balloon. The length of the distal region of the balloon is greater than approximately 15% of the combined length of the proximal and central regions of the balloon. A driveline may be coupleable to the opening and have a connection element disposed at a proximal end of the driveline. A radio opaque marker may be integrated into the driveline at a distal end of the driveline.
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
A61M 60/843 - Balloon aspects, e.g. shapes or materials
8.
INTRA-AORTIC BALLOON PUMP ASSEMBLY WITH PRESSURE SENSOR
An intra-aortic balloon pump (IABP) assembly is configured to be positioned in a patient's descending aorta to provide support to the patient. The IABP assembly includes an expandable member having a distal end and a proximal end and a driveline having a distal end and a proximal end, the distal end of the driveline is configured to be coupleable to the proximal end of the expandable member. The IABP assembly also includes a first driveline pressure sensor device disposed within the driveline that is configured to generate a first driveline pressure signal communicative of the pressure of the environment external to the driveline. The first driveline pressure sensor device includes a first driveline sensing element that is sensitive to changes in ambient pressure and positioned at or proximate to the distal end of the driveline.
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
A61M 60/538 - Regulation using real-time blood pump operational parameter data, e.g. motor current
9.
DRIVE UNIT FOR INTRAVASCULAR CIRCULATORY SUPPORT SYSTEMS
A drive unit for intravascular circulatory support systems may include a motor, a ball nut, a ball screw, and a bellows. The motor may include a rotor and a stator. The ball nut may be affixed to the rotor. The bellows may have a first end and an second end and a bellows cavity located there between. The first end may be in fixed position and the second end may be defined by a dynamic flange having a recess carried by the bellows cavity. In turn, the recess of the dynamic flange may carry at least a portion of the motor. The second end may also receive the ball screw. Rotation of the rotor causes linear motion of the ball screw within the ball nut to actuate the bellows.
A61M 60/497 - Details relating to driving for balloon pumps for circulatory assistance
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 60/515 - Regulation using real-time patient data
10.
DRIVE UNIT FOR INTRAVASCULAR CIRCULATORY SUPPORT SYSTEMS
A drive unit for intravascular circulatory support systems may include a motor, a ball nut, a ball screw, and a bellows. The motor may include a rotor and a stator. The ball nut may be affixed to the rotor. The bellows may have a first end and an second end and a bellows cavity located there between. The first end may be in fixed position and the second end may be defined by a dynamic flange having a recess carried by the bellows cavity. In turn, the recess of the dynamic flange may carry at least a portion of the motor. The second end may also receive the ball screw. Rotation of the rotor causes linear motion of the ball screw within the ball nut to actuate the bellows.
The present disclosure is directed towards systems and methods built for predictively timing the inflation and/or deflation of an intra-aortic balloon pump. A controller operates in three states: (1) initialization state, (2) learning state, and (3) peak detection state. The controller decomposes a patient's electrocardiogram signal to a power signal. It then learns characteristics of the patient's electrocardiogram signal during the learning state and computes adaptive threshold parameter values. During the peak detection state, the controller applies the learnt threshold parameter values on a current electrocardiogram signal to identify occurrence and timings of R peaks in the electrocardiogram signal. The R-to-R peak timings are then used to trigger inflation of an intra-aortic balloon pump.
A61B 5/347 - Detecting the frequency distribution of signals
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 60/295 - Balloon pumps for circulatory assistance
Intravascularly delivered blood pumps and associated devices, systems, and methods, are disclosed herein. A method of intravascularly delivering a blood pump in accordance with embodiments of the present technology can include, for example, advancing an elongated delivery dilator through a patient's vasculature such that a first portion of the elongated delivery dilator is externally accessible proximate to the subclavian artery and a second portion of the elongated delivery dilator is externally accessible proximate to the femoral artery. The method can further include attaching the second portion of the elongated delivery dilator to a driveline, which is coupled to a balloon at the opposite end, and then pulling on the first portion of the elongated delivery dilator to move the driveline and the balloon through the patient's vasculature to a target site with the balloon positioned within the aorta.
Intravascularly delivered blood pumps and associated devices, systems, and methods, are disclosed herein. A system for intravascularly implanting a blood pump in accordance with embodiments of the present technology can include, for example, an elongated delivery dilator having a first end portion, a second end portion, and a lumen extending between the first end portion and the second end portion. The elongated delivery dilator is configured to advance over a guidewire positioned within the patient's vasculature and to extend through the patient's vasculature between a first blood vessel and a second blood vessel. A pump assembly includes an expandable member and a driveline. The expandable member is configured to be positioned in a patient's descending aorta to provide circulatory support to the patient's heart.
A61M 39/06 - Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
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 60/178 - Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient’s body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
The present disclosure is directed towards systems and methods built for predictively timing the inflation and/or deflation of an intra-aortic balloon pump. A controller operates in three states: (1) initialization state, (2) learning state, and (3) peak detection state. The controller decomposes a patient's electrocardiogram signal to a power signal. It then learns characteristics of the patient's electrocardiogram signal during the learning state and computes adaptive threshold parameter values. During the peak detection state, the controller applies the learnt threshold parameter values on a current electrocardiogram signal to identify occurrence and timings of R peaks in the electrocardiogram signal. The R-to-R peak timings are then used to trigger inflation of an intra-aortic balloon pump.
A61B 5/316 - Modalities, i.e. specific diagnostic methods
A61B 5/352 - Detecting R peaks, e.g. for synchronising diagnostic apparatusEstimating R-R interval
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
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
15.
PREDICTIVE QRS DETECTION AND R-TO-R TIMING SYSTEMS AND METHODS
The present disclosure is directed towards systems and methods built for predictively timing the inflation and/or deflation of an intra-aortic balloon pump. A controller operates in three states: (1) initialization state, (2) learning state, and (3) peak detection state. The controller decomposes a patient's electrocardiogram signal to a power signal. It then learns characteristics of the patient's electrocardiogram signal during the learning state and computes adaptive threshold parameter values. During the peak detection state, the controller applies the learnt threshold parameter values on a current electrocardiogram signal to identify occurrence and timings of R peaks in the electrocardiogram signal. The R-to-R peak timings are then used to trigger inflation of an intra-aortic balloon pump.
The present disclosure is directed towards systems and methods built for predictively timing the inflation and/or deflation of an intra-aortic balloon pump. A controller operates in three states: (1) initialization state, (2) learning state, and (3) peak detection state. The controller decomposes a patient's electrocardiogram signal to a power signal. It then learns characteristics of the patient's electrocardiogram signal during the learning state and computes adaptive threshold parameter values. During the peak detection state, the controller applies the learnt threshold parameter values on a current electrocardiogram signal to identify occurrence and timings of R peaks in the electrocardiogram signal. The R-to-R peak timings are then used to trigger inflation of an intra-aortic balloon pump.
Medical apparatus for the treatment of heart failure;
Medical apparatus, namely, an intravascular ventricular
assist system comprised of a blood pump, skin interface
device, arterial interface device, subcutaneous ECG leads,
internal drive line, and drive unit for use in the treatment
of advanced heart failure; Medical devices for supporting
cardiac function in humans, namely, blood pumps for use in
the cardiovascular system to the heart, catheters,
intravascular access devices and external power sources
specially adapted therefor, sold as a unit.
(1) Medical apparatus for the treatment of heart failure; Medical apparatus, namely, an intravascular ventricular assist system comprised of a blood pump, skin interface device, arterial interface device, subcutaneous ECG leads, internal drive line, and drive unit for use in the treatment of advanced heart failure; Medical devices for supporting cardiac function in humans, namely, blood pumps for use in the cardiovascular system to the heart, catheters, intravascular access devices and external power sources specially adapted therefor, sold as a unit.
The invention provides an introducer assembly for delivering a blood pump into vasculature of a subject, as well as a method for utilizing the assembly.
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 60/148 - 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
Medical apparatus for the treatment of heart failure; Medical apparatus, namely, an intravascular ventricular assist system comprised of a blood pump, skin interface device, arterial interface device, subcutaneous ECG leads, internal drive line, and drive unit for use in the treatment of advanced heart failure; Medical devices for supporting cardiac function in humans, namely, blood pumps for use in the cardiovascular system to the heart, catheters, intravascular access devices and external power sources specially adapted therefor, sold as a unit
21.
BLOOD PUMP DEVICES AND ASSOCIATED SYSTEMS AND METHODS
The present technology provides a blood pump device and associated systems and methods of use thereof to assist blood circulation in a patient. The blood pump device includes a flexible member disposed within a housing. Movement of the flexible member in the housing varies the volume of chambers within the housing and effectuates pumping of blood to and from a vessel in fluid connection with a chamber of the blood pump device.
The present technology provides a blood pump device and associated systems and methods of use thereof to assist blood circulation in a patient. The blood pump device includes a flexible member disposed within a housing. Movement of the flexible member in the housing varies the volume of chambers within the housing and effectuates pumping of blood to and from a vessel in fluid connection with a chamber of the blood pump device.
A61M 60/274 - Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders the inlet and outlet being the same, e.g. para-aortic counter-pulsation blood pumps
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 60/268 - 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 60/892 - Active valves, i.e. actuated by an external force
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
The invention provides a blood pump for use with an intravascular ventricular assist system (iVAS), as well as a method for utilizing the blood pump to treat heart failure.
The invention provides a blood pump for use with an intravascular ventricular assist system (iVAS), as well as a method for utilizing the blood pump to treat heart failure.
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 60/139 - 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 60/865 - Devices for guiding or inserting pumps or pumping devices into the patient’s body
A61M 60/867 - Devices for guiding or inserting pumps or pumping devices into the patient’s body using position detection during deployment, e.g. for blood pumps mounted on and driven through a catheter
A61M 60/843 - Balloon aspects, e.g. shapes or materials
A61M 60/295 - Balloon pumps for circulatory assistance
A61M 60/497 - Details relating to driving for balloon pumps for circulatory assistance
A61M 60/861 - Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient’s body
The invention provides an introducer assembly for delivering a blood pump into vasculature of a subject, as well as a method for utilizing the assembly.
The invention provides an introducer assembly for delivering a blood pump into vasculature of a subject, as well as a method for utilizing the assembly.
A skin interface device (“SID”) for a cardiac assist device, including a SID cap having a first housing, an annular sleeve, and a first annular winding disposed over said annular sleeve. The SID further includes a SID base having a second housing formed to include a tubular portion, a cylindrical member disposed in said tubular portion, and a second annular winding disposed around said cylindrical member. The SID cap is configured to be rotationally attached to said SID base. When the SID cap is attached to the SID base, the second annular winding is disposed within the first annular winding, and the relative positions of the first annular winding and the second annular winding are fixed both laterally and vertically.
The present invention provides a skin attachment device for use with implantable medical devices which extend through the skin for prolonged durations.
A skin interface device (“SID”) for a cardiac assist device, including a SID cap having a first housing, an annular sleeve, and a first annular winding disposed over said annular sleeve. The SID further includes a SID base having a second housing formed to include a tubular portion, a cylindrical member disposed in said tubular portion, and a second annular winding disposed around said cylindrical member. The SID cap is configured to be rotationally attached to said SID base. When the SID cap is attached to the SID base, the second annular winding is disposed within the first annular winding, and the relative positions of the first annular winding and the second annular winding are fixed both laterally and vertically.
