Abstract: Forming a proximal anastomosis on an aortic wall includes method and instrumentation and apparatus for forming an aortic puncture and inserting into the vessel through the puncture a fluid-impervious sealing element with a protruding retainer. An anastomosis of a graft vessel over the puncture is partially completed with the retainer of the sealing element protruding through the partial anastomosis. The retainer facilitates removal of the sealing element from the partial anastomosis prior to completion of the procedure.

Abstract: Forming a proximal anastomosis on an aortic wall includes method and instrumentation and apparatus for forming an aortic puncture and inserting into the vessel through the puncture a fluid-impervious sealing element with a protruding retainer. An anastomosis of a graft vessel over the puncture is partially completed with the retainer of the sealing element protruding through the partial anastomosis. The retainer facilitates removal of the sealing element from the partial anastomosis prior to completion of the procedure.

Abstract: An apparatus for endovascularly replacing a patient's heart valve. In some embodiments, the apparatus includes a replacement heart valve implant comprising a valve and an expandable anchor; and a deployment tool adapted to endovascularly deliver the replacement heart valve implant to an implant site within the patient, the deployment tool comprising an actuator adapted to exert an axially directed force on the anchor. The invention also provides a method for endovascularly replacing a heart valve of a patient. In some embodiments, the method includes the steps of endovascularly delivering a replacement heart valve implant having a valve and an anchor to an implant site within the patient; and applying an axially directed force from an actuator outside of the patient to the anchor. In invention also provides deployment tools for performing the method.

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: Forming a proximal anastomosis on an aortic wall includes method and instrumentation and apparatus for forming an aortic puncture and inserting a fluid-impervious sealing element with a lateral flange and central stem into the vessel through the puncture. An anastomosis of a graft vessel over the puncture is partially completed with the central stem of the sealing element protruding through the partial anastomosis. A removal instrument attaches to the central stem and retrieves the sealing element that disassembles in helical disassociation of the flange and stem into a continuous strand that is withdrawn from the partial anastomosis prior to completion of the procedure.

Abstract: A support member for a catheter sheath is disclosed. The support member has a series of ribs with a distal member having integrated fingers for providing radial compliance. The support member provides sufficient axial stiffness to provide a desired pushability of a minimally invasive device for replacing a heart valve. Various alternative embodiments are also described.

Abstract: A positioning anchor is provided for a stent-graft for implantation to treat a damaged body lumen. The positioning anchor is generally tubular surrounding a primary fluid conduit. Arms extend laterally from the generally tubular structure of the anchor surrounding lateral fluid conduits. The form of these arms is preferably custom configured to match a particular patient's luminal geometry. The anchor thus fits within the luminal geometry to remain in a desired fixed position for implantation of the anchor and any stent-graft coupled to the anchor. The anchor is most preferably formed with two walls having a void therebetween which can be filled with fixation media to further secure the anchor at the desired implantation site. A lumen shaper balloon and delivery catheter are also disclosed for proper delivery, expansion and inflation of the positioning anchor and stent-graft elements according to this invention.

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 present invention provides methods and apparatus for endovascularly replacing a patient's heart valve. The apparatus includes a replacement valve and an anchor having an expandable braid. In some embodiments, the expandable braid is fabricated from a single strand of wire. In some embodiments, the expandable braid comprises at least one turn feature. The anchor and the valve preferably are configured for endovascular delivery and deployment.

Abstract: The present invention relates to apparatus and methods for performing valvuloplasty. In some embodiments, the apparatus includes an expandable braid valvuloplasty device. In some embodiments, the methods and apparatus may be used as an adjunct to percutaneous heart valve replacement. In some embodiments, the apparatus and methods may provide a medical practitioner with feedback, monitoring or measurement information, e.g., information relevant to percutaneous transcatheter heart valve replacement.

Abstract: A medical implant deployment tool and deployment method are disclosed. One aspect of the invention provides an implant system including an implant adapted for endovascular delivery and deployment; and a deployment tool adapted to deploy the implant, with the deployment tool having an actuation controller; a plurality of actuation elements adapted to apply forces to one or more implant deployment mechanisms and each adapted to extend along an actuation element path within a patient's vasculature; and an actuation element compensation mechanism adapted to compensate for differences in length between the actuation element paths.

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: Methods and devices which a surgeon may use to stabilize the beating heart during a surgical procedure on the heart. A stabilizing device may be introduced through an opening in the chest and brought into contact with the beating heart. By contacting the heart with the device and by exerting a stabilizing force on the device, the motion of the heart caused by the contraction of the heart muscles in a vicinity of a site of surgery to be performed, is effectively eliminated. A surgeon may contact the heart with the stabilizing means, assess the degree of movement of the anastomosis site, and exert a force on the stabilizing means such that the contraction of the beating heart causes only minimal excess motion at the surgery site. The stabilizing means may be attached to a rigid support or may be attached to a semi-rigid support which is rendered motionless mechanically, chemically, or by human intervention.

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: 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 present invention provides intravascular embolic protection apparatus including a blood filter element having an accommodating passageway adapted to permit passage of a procedure device therethrough and to substantially seal against passage of particles between the embolic protection apparatus and the procedure device by accommodating to a size and shape of the procedure device. Furthermore, the present invention provides a method of performing an endovascular procedure on a patient including the steps of delivering an embolic protection apparatus to a location within a vascular lumen of the patient; passing a procedure device through an accommodating passageway of the apparatus, the accommodating passageway accommodating to a size and shape of the procedure device; performing the endovascular procedure; and removing the procedure device from the patient.

Abstract: Forming a proximal anastomosis on an aortic wall includes method and instrumentation and apparatus for forming an aortic puncture and inserting a fluid-impervious sealing element with a lateral flange and central stem into the vessel through the puncture. An anastomosis of a graft vessel over the puncture is partially completed with the central stem of the sealing element protruding through the partial anastomosis. A removal instrument attaches to the central stem and retrieves the sealing element that disassembles in helical disassociation of the flange and stem into a continuous strand that is withdrawn from the partial anastomosis prior to completion of the procedure.

Abstract: An apparatus for endovascularly replacing a patient's heart valve. In some embodiments, the apparatus includes a replacement heart valve implant comprising a valve and an expandable anchor; and a deployment tool adapted to endovascularly deliver the replacement heart valve implant to an implant site within the patient, the deployment tool comprising an actuator adapted to exert an axially directed force on the anchor. The invention also provides a method for endovascularly replacing a heart valve of a patient. In some embodiments, the method includes the steps of endovascularly delivering a replacement heart valve implant having a valve and an anchor to an implant site within the patient; and applying an axially directed force from an actuator outside of the patient to the anchor. In invention also provides deployment tools for performing the method.