Abstract: The invention provides a device for fine adjustment of a prosthetic valve device and a method of adjusting the position of a prosthetic valve after implantation. The adjustment mechanism includes complementary structures on a valve member and device frame that cooperate to provide relative axial and/or angular motion between the valve member and device frame (and thus the native vessel). The adjustment mechanism of the invention may also include a means for selectively maintaining the relative position of the valve member and device frame. The device and method are particularly applicable for use with a modular prosthetic valve device that is assembled in the body lumen.

Abstract: The present invention relates to methods and compositions designed for the treatment or management of acute coronary syndromes, particularly, unstable angina and acute myocardial infarction. The methods of the invention comprise the administration of an effective amount of a formulation containing one or more therapeutic agents which specifically decreases or inhibits the activity of phagocytic cells and/or eliminates or diminishes the amount of phagocytic cells including, but not limited to, macrophages and monocytes. The formulations are specifically targeted to phagocytic cells. The invention also provides pharmaceutical compositions of formulations containing one or more therapeutic agents of the invention for administration to subjects currently suffering from or having recently suffered an acute coronary syndrome such as unstable angina and acute myocardial infarction.

Abstract: The devices and methods generally relate to vibratable sensors for measuring ambient fluid pressure, in particular implantable sensors. The devices and methods are particularly well-suited to implantation within the body of a living animal or human to monitor physiological conditions, such as portal and/or hepatic venous blood pressure, and allow frequent, remote interrogation of venous pressure using the resonance frequency of an implanted sensor. The sensor devices are relatively small compared to conventional devices for measuring fluid pressure and can be implanted in the porto-hepatic venous system, whereas conventional devices are too large. The small size of the device is accomplished by using a thick sensor membrane, compared to conventional devices, and by limiting the size of additional elements of the device relative to the size of the sensor membrane. The thicker sensor member also obviates the need for multiple sensor arrays and maintains the accuracy and robustness of the sensor device.

Abstract: The devices and methods generally relate to vibratable sensors for measuring ambient fluid pressure, in particular implantable sensors. The devices and methods are particularly well-suited to implantation within the body of a living animal or human to monitor physiological conditions, such as portal and/or hepatic venous blood pressure, and allow frequent, remote interrogation of venous pressure using the resonance frequency of an implanted sensor. The sensor devices are relatively small compared to conventional devices for measuring fluid pressure and can be implanted in the porto-hepatic venous system, whereas conventional devices are too large. The small size of the device is accomplished by using a thick sensor membrane, compared to conventional devices, and by limiting the size of additional elements of the device relative to the size of the sensor membrane. The thicker sensor member also obviates the need for multiple sensor arrays and maintains the accuracy and robustness of the sensor device.

Abstract: The present invention relates to a liposomal formulation containing a therapeutic agent and a process for producing the formulation. The liposomal formulation comprises particular characteristics that enhance uniformity and stability of the formulation. The manufacturing process is a novel process that produces a liposomal formulation of a uniform size with many desirable properties that may be independently controlled. Further, the invention relates to a liposome formulation made in accordance with the manufacturing process.

Abstract: The present invention relates to a liposomal formulation containing a therapeutic agent and a process for producing the formulation. The liposomal formulation comprises particular characteristics that enhance uniformity and stability of the formulation. The manufacturing process is a novel process that produces a liposomal formulation of a uniform size with many desirable properties that may be independently controlled. Further, the invention relates to a liposome formulation made in accordance with the manufacturing process.

Abstract: The present invention relates to use of bisphosphonate formulations for the treatment and management of HIV/AIDS. The method of the invention comprises administering a formulation comprising an effective amount of a bisphosphonate that specifically inhibits the activity and/or decreases the number of monocytes and/or macrophages, thereby reducing or eliminating HIV reservoirs. The invention also provides a method of complementing an HIV antiviral therapy, such as the highly active antiretroviral therapy (HAART), with a bisphosphonate formulation to improve clinical outcome.

Abstract: The present invention relates to methods and compositions designed for the treatment or management of acute coronary syndromes, particularly, unstable angina and acute myocardial infarction. The methods of the invention comprise the administration of an effective amount of a formulation containing one or more therapeutic agents which specifically decreases or inhibits the activity of phagocytic cells and/or eliminates or diminishes the amount of phagocytic cells including, but not limited to, macrophages and monocytes. The formulations are specifically targeted to phagocytic cells. The invention also provides pharmaceutical compositions of formulations containing one or more therapeutic agents of the invention for administration to subjects currently suffering from or having recently suffered an acute coronary syndrome such as unstable angina and acute myocardial infarction.

Abstract: The present invention relates to methods and compositions designed for the treatment or management of acute coronary syndromes, particularly, unstable angina and acute myocardial infarction. The methods of the invention comprise the administration of an effective amount of a formulation containing one or more therapeutic agents which specifically decreases or inhibits the activity of phagocytic cells and/or eliminates or diminishes the amount of phagocytic cells including, but not limited to, macrophages and monocytes. The formulations are specifically targeted to phagocytic cells. The invention also provides pharmaceutical compositions of formulations containing one or more therapeutic agents of the invention for administration to subjects currently suffering from or having recently suffered an acute coronary syndrome such as unstable angina and acute myocardial infarction.

Abstract: The present invention relates to use of bisphosphonate formulations for the treatment and management of HIV/AIDS. The method of the invention comprises administering a formulation comprising an effective amount of a bisphosphonate that specifically inhibits the activity and/or decreases the number of monocytes and/or macrophages, thereby reducing or eliminating HIV reservoirs. The invention also provides a method of complementing an HIV antiviral therapy, such as the highly active antiretroviral therapy (HAART), with a bisphosphonate formulation to improve clinical outcome.

Abstract: A percutaneous device including a temporary valve attached to a sheath, the sheath having an inverting section for delivery and removal thereof from a blood vessel. The sheath is inverted for delivery, housing the valve between inverted layers thereof. To deploy said valve, the sheath is everted to position the temporary valve on an outer surface thereof. The temporary valve and sheath are reversibly movable between inverted and deployed configurations. Upon eversion, the temporary valve assumes a radially expanded canopy shape having an outer diameter selected to contact the vessel wall and allow blood flow in only one direction. The temporary valve may be removed by releasing one end of the valve from the sheath, flattening the temporary valve along the longitudinal axis of the sheath. Also provided is a temporary valve system comprising a dilator for inverting and everting the sheath, said dilator being removably connected to the sheath.

Abstract: A system and process for placing a percutaneous valve device in a body lumen at the location of implantation is provided which enhances the accuracy of the placement. Anchors and placement wires are used to fix the implantation target and guide the device to the implantation site. The system and method are applicable to pre-assembled percutaneous valve devices as well as a modular prosthetic valve device. The modular valve device comprises two or more device modules and is designed to be delivered unassembled and then assembled in the body lumen at or near the site where implantation occurs. The device modules may be assembled before or after the implantation target is fixed with the anchor, and then placed using the placement system in a manner similar to how a pre-assembled percutaneous valve device may be placed in accordance with the invention.

Abstract: The invention provides a multi-component (modular) percutaneous valve device that includes a valve module having valve leaflets and a valve frame. The valve frame includes one or more, for example two, ring members and a plurality of masts. Also provided is a valve frame having specially designed pivot points at the connection between masts and first and second ring members to assist folding the valve module and minimizing delivery diameter. The valve frame may also include wire guides to facilitate combining the valve module with a support module. The masts or a ring of the valve frame may also include locking members, such as shafts for closing the valve module and securing the valve module to the support module. The support module includes corresponding locking members, such as spears that align with the shafts on the valve module for assembly and locking the valve module to the support module.

Abstract: A system and process for placing a percutaneous valve device in a body lumen at the location of implantation is provided, which enhances the accuracy of the placement. Anchors and placement wires are used to fix the implantation target and guide the device to the implantation site. The system and method are applicable to preassembled percutaneous valve devices as well as a modular prosthetic valve device. The modular valve device comprises two or more device modules and is designed to be delivered unassembled and then assembled in the body lumen at or near the site where implantation occurs. The device modules may be assembled before or after the implantation target is fixed with the anchor, and then placed using the placement system in a manner similar to how a preassembled percutaneous valve device may be placed in accordance with the invention.

Abstract: The invention provides a multi-component (modular) percutaneous valve device that includes a valve module having valve leaflets and a valve frame. The valve frame includes one or more, for example two, ring members and a plurality of masts. Also provided is a valve frame having specially designed pivot points at the connection between masts and first and second ring members to assist folding the valve module and minimizing delivery diameter. The valve frame may also include wire guides to facilitate combining the valve module with a support module. The masts or a ring of the valve frame may also include locking members, such as shafts for closing the valve module and securing the valve module to the support module. The support module includes corresponding locking members, such as spears that align with the shafts on the valve module for assembly and locking the valve module to the support module.

Abstract: The present invention relates to methods and compositions designed for the treatment or management of acute coronary syndromes, particularly, unstable angina and acute myocardial infarction. The methods of the invention comprise the administration of an effective amount of a formulation containing one or more therapeutic agents which specifically decreases or inhibits the activity of phagocytic cells and/or eliminates or diminishes the amount of phagocytic cells including, but not limited to, macrophages and monocytes. The formulations are specifically targeted to phagocytic cells. The invention also provides pharmaceutical compositions of formulations containing one or more therapeutic agents of the invention for administration to subjects currently suffering from or having recently suffered an acute coronary syndrome such as unstable angina and acute myocardial infarction.

Abstract: The invention provides a device for fine adjustment of a prosthetic valve device and a method of adjusting the position of a prosthetic valve after implantation. The adjustment mechanism includes complementary structures on a valve member and device frame that cooperate to provide relative axial and/or angular motion between the valve member and device frame (and thus the native vessel). The adjustment mechanism of the invention may also include a means for selectively maintaining the relative position of the valve member and device frame. The device and method are particularly applicable for use with a modular prosthetic valve device that is assembled in the body lumen.

Abstract: A method and an apparatus to create a more favorable flow regime in a lumen. An artificial shape in the lumen is created to at least one of eliminate flow disturbances and enhance aspects of fluid flow through a treatment site.

Abstract: The present invention provides a modular prosthetic valve device having two or more device modules for percutaneous delivery unassembled at or near the valve implantation site and assembly at least in part using a self-assembly member, and a system and method of folding, delivering and assembling the device. The device modules may include a support structure and a valve module. The valve module has an unassembled, folded delivery configuration, and an unfolded, assembled (via the self-assembly member) working configuration. The valve module may be a single-piece leaflets substructure or a plurality of valve sections. The self-assembly member has a delivery configuration and may be reverted to a preset configuration for valve module assembly. The unassembled valve module may be rolled along its circumferential axis towards its height to a folded diameter equivalent to one rolled leaflet, providing a percutaneous valve device having a smaller delivery diameter than pre-assembled valve devices.

Abstract: A method and an apparatus to create a more favorable flow regime in a lumen. An artificial shape in the lumen is created to at least one of eliminate flow disturbances and enhance aspects of fluid flow through a treatment site.