Abstract: The present invention relates to apparatus and methods for endovascularly delivering and releasing a prosthesis, e.g., an aortic prosthesis, within and/or across a patient's native heart valve, referred to hereinafter as replacing the patient's heart valve. In some embodiments the delivery system comprises a plurality of first actuatable element adapted to engage a plurality of second elements in a first configuration to capture the implant within the delivery system, and wherein the plurality of first actuatable element are adapted to engage the plurality of second elements in a second configuration and to release the implant from the delivery system.

Abstract: Apparatus for endovascularly replacing a patient's heart valve, including: a replacement valve adapted to be delivered endovascularly to a vicinity of the heart valve; an expandable anchor adapted to be delivered endovascularly to the vicinity of the heart valve; and a lock mechanism configured to maintain a minimum amount of anchor expansion. The invention also includes a method for endovascularly replacing a patient's heart valve. In some embodiments the method includes the steps of: endovascularly delivering a replacement valve and an expandable anchor to a vicinity of the heart valve; expanding the anchor to a deployed configuration; and locking the anchor in the deployed configuration.

Abstract: The invention includes methods of and apparatus for endovascularly replacing a heart valve of a patient. One aspect of the invention provides a method including the steps of endovascularly delivering a replacement valve and an expandable anchor to a vicinity of the heart valve in an unexpanded configuration; and applying an external non-hydraulically expanding or non-pneumatically expanding actuation force on the anchor to change the shape of the anchor, such as by applying proximally and/or distally directed force on the anchor using a releasable deployment tool to expand and contract the anchor or parts of the anchor. Another aspect of the invention provides an apparatus including a replacement valve; an anchor; and a deployment tool comprising a plurality of anchor actuation elements adapted to apply a non-hydraulically expanding or non-pneumatically expanding actuation force on the anchor to reshape the anchor.

Abstract: Steerable medical delivery devices and their methods of use.

Abstract: The invention includes methods of and apparatus for endovascularly replacing a heart valve of a patient. One aspect of the invention provides a method including the steps of endovascularly delivering a replacement valve and an expandable anchor in an unexpanded configuration within a sheath to a vicinity of the heart valve; deploying the anchor from the sheath; expanding the anchor with a deployment tool comprising a plurality of actuation elements to contact tissue at an anchor site; and retrieving the anchor into the sheath.

Abstract: The invention provides a two-part package and method of use for a pre-attached medical implant and delivery tool system. The package includes a wet compartment and a dry compartment and allows a pre-attached implant and delivery tool system to be at least partially stored immersed in a fluid in the wet compartment and at least partially stored in the dry compartment. In one embodiment the implant comprises a replacement heart valve, and the heart valve is stored inside the wet compartment while the heart valve delivery tool remains dry in the dry compartment.

Abstract: The invention provides a two-part package and method of use for a pre-attached medical implant and delivery tool system. The package includes a wet compartment and a dry compartment and allows a pre-attached implant and delivery tool system to be at least partially stored immersed in a fluid in the wet compartment and at least partially stored in the dry compartment. In one embodiment the implant comprises a replacement heart valve, and the heart valve is stored inside the wet compartment while the heart valve delivery tool remains dry in the dry compartment.

Abstract: Apparatus and methods for pumping and oxygenating blood are provided that include a gas removal system. An integrated blood processing unit is provided in which a gas removal/blood filter, pump and blood oxygenation element are mounted within a common housing. The gas removal system includes a sensor mounted on the housing to sense the presence of gas, and a valve is operably coupled to the sensor to evacuate gas from the system when the sensor detects an accumulation of gas.

Abstract: A method for percutaneously replacing a heart valve of a patient. In some embodiments the method includes the steps of percutaneously delivering a replacement valve and an expandable anchor to a vicinity of the heart valve in an unexpanded configuration; expanding the anchor to a deployed configuration in which the anchor contacts tissue at a first anchor site; repositioning the anchor to a second anchor site; and deploying the anchor at the second anchor site.

Abstract: Apparatus for endovascularly replacing a patient's heart valve, including: a delivery catheter having a diameter of 21 french or less; an expandable anchor disposed within the delivery catheter; and a replacement valve disposed within the delivery catheter. The invention also includes a method for endovascularly replacing a heart valve of a patient. In some embodiments the method includes the steps of: inserting a catheter having a diameter no more than 21 french into the patient; endovascularly delivering a replacement valve and an expandable anchor to a vicinity of the heart valve through the catheter; and deploying the anchor and the replacement valve.

Abstract: Apparatus for endovascularly replacing a patient's heart valve, including: a delivery catheter having a diameter of 21 french or less; an expandable anchor disposed within the delivery catheter; and a replacement valve disposed within the delivery catheter. The invention also includes a method for endovascularly replacing a heart valve of a patient. In some embodiments the method includes the steps of: inserting a catheter having a diameter no more than 21 french into the patient; endovascularly delivering a replacement valve and an expandable anchor to a vicinity of the heart valve through the catheter; and deploying the anchor and the replacement valve.

Abstract: Methods and devices for assessing the operation of a replacement heart valve. The method includes endovascularly delivering a replacement heart valve to a vicinity of a heart valve in an unexpanded configuration, and assessing the operation of the replacement heart valve in the vicinity of the heart valve before fully expanding the replacement heart valve. Methods and devices for assessing the location of a replacement heart valve. The method includes endovascularly delivering a replacement heart valve to a vicinity of the heart valve in an unexpanded configuration, expanding the replacement heart valve to a partially deployed configuration, and assessing the location of the replacement heart valve in the vicinity of the heart valve before fully expanding the replacement heart valve.

Abstract: The present invention relates to apparatus and methods for endovascularly delivering and releasing a prosthesis, e.g., an aortic prosthesis, within and/or across a patient's native heart valve, referred to hereinafter as replacing the patient's heart valve. In some embodiments the delivery system comprises a plurality of first actuatable element adapted to engage a plurality of second elements in a first configuration to capture the implant within the delivery system, and wherein the plurality of first actuatable element are adapted to engage the plurality of second elements in a second configuration and to release the implant from the delivery system.

Abstract: The invention provides a two-part package and method of use for a pre-attached medical implant and delivery tool system. The package includes a wet compartment and a dry compartment and allows a pre-attached implant and delivery tool system to be at least partially stored immersed in a fluid in the wet compartment and at least partially stored in the dry compartment. In one embodiment the implant comprises a replacement heart valve, and the heart valve is stored inside the wet compartment while the heart valve delivery tool remains dry in the dry compartment.

Abstract: The invention includes methods of and apparatus for endovascularly replacing a heart valve of a patient. One aspect of the invention provides a method including the steps of endovascularly delivering a replacement valve and an expandable anchor to a vicinity of the heart valve in an unexpanded configuration; and applying an external non-hydraulic or non-pneumatic actuation force on the anchor to change the shape of the anchor, such as by applying proximally and/or distally directed force on the anchor using a releasable deployment tool to expand and contract the anchor or parts of the anchor.

Abstract: The invention includes methods of and apparatus for endovascularly replacing a heart valve of a patient. One aspect of the invention provides a method including the steps of endovascularly delivering a replacement valve and an expandable anchor to a vicinity of the heart valve in an unexpanded configuration; and applying an external non-hydraulically expanding or non-pneumatically expanding actuation force on the anchor to change the shape of the anchor, such as by applying proximally and/or distally directed force on the anchor using a releasable deployment tool to expand and contract the anchor or parts of the anchor. Another aspect of the invention provides an apparatus including a replacement valve; an anchor; and a deployment tool comprising a plurality of anchor actuation elements adapted to apply a non-hydraulically expanding or non-pneumatically expanding actuation force on the anchor to reshape the anchor.

Abstract: Apparatus for oxygenating and pumping blood includes a housing defining a blood flow path including, in series, a gas collection plenum, a pump space and a blood oxygenation element. A pump disposed in the pump space is configured to draw blood from the gas collection plenum and propel blood from the pump space through a heat exchanger and the blood oxygenation element. The heat exchanger includes a heat exchange plate and a coolant space.

Abstract: Apparatus for oxygenating and pumping blood includes a housing defining a blood flow path including, in series, a gas collection plenum, a pump space and a blood oxygenation element. A pump disposed in the pump space is configured to draw blood from the gas collection plenum and propel blood from the pump space through a heat exchanger and the blood oxygenation element. The heat exchanger includes a heat exchange plate and a coolant space.

Abstract: Apparatus and methods for pumping and oxygenating blood are provided that include a gas removal system. An integrated blood processing unit is provided in which a gas removal/blood filter, pump and blood oxygenation element are mounted within a common housing. The gas removal system includes a sensor mounted on the housing to sense the presence of gas, and a valve is operably coupled to the sensor to evacuate gas from the system when the sensor detects an accumulation of gas.

Abstract: Apparatus and methods for pumping and oxygenating blood are provided that include a gas removal system. An integrated blood processing unit is provided in which a gas removal/blood filter, pump and blood oxygenation element are mounted within a common housing. The gas removal system includes a sensor mounted on the housing to sense the presence of gas, and a valve is operably coupled to the sensor to evacuate gas from the system when the sensor detects an accumulation of gas.