Abstract: Apparatus for reconfiguring tissue, the apparatus comprising a shaft having a distal end and a proximal end; at least one effector mechanism movably mounted to the distal end of the shaft, each effector mechanism comprising at least one gripping element for gripping tissue to that effector mechanism, the at least one effector mechanism being configured to capture the gripped tissue against said shaft, at least one actuating mechanism mounted to the proximal end of the shaft, and at least one connection mechanism connecting the at least one actuating mechanism to the at least one effector mechanism, whereby a user may utilize the at least one actuating mechanism to actuate the at least one effector mechanism so as to reconfigure tissue.

Abstract: Apparatus for filtering and entrapping debris in the vascular system of a patient, the apparatus including a filter to allow blood to flow therethrough and to restrict passage of debris, wherein the filter captures debris carried in a first direction of blood flow. The apparatus further includes an entrapment mechanism which allows passage of debris and blood therethrough, in the first direction of blood flow and prevents debris passage in a second direction. The entrapment mechanism and filter allow blood and debris therethrough in the first direction of blood flow. The entrapment mechanism prevents debris flow in the second direction of blood flow. A method for filtering and entrapping debris in the vascular system includes inserting the apparatus into the vascular system, allowing blood and debris carried therein to flow through the entrapment mechanism, and removing the apparatus and accumulated debris from the vascular system.

Abstract: A fixation band has a tubular frame and a tube, wherein the tubular frame comprises longitudinally-extending members having a hook on its distal end and fixation means on its proximal end. The tubular frame preferably comprises a laterally-extending member for stabilization. The tube is positioned inside longitudinally-extending members and a sewing cuff is formed in the tube distal to the distalmost end of the longitudinally-extending members. A standard prosthetic valve can be secured to the fixation band by suturing the prosthetic valve's sewing cuff to the fixation band's sewing cuff and the prosthetic valve can be advanced to a valve seat. By pulling the tubular frame proximally, the hooks pass into surrounding tissue so that the fixation band and prosthetic valve are fixed against proximal movement. The fixation means then secure the fixation band to the surrounding tissue so that the prosthetic valve is fixed against distal movement.

Abstract: Apparatus for reconfiguring tissue, the apparatus comprising a shaft having a distal end and a proximal end; at least one effector mechanism movably mounted to the distal end of the shaft, each effector mechanism comprising at least one gripping element for gripping tissue to that effector mechanism, the at least one effector mechanism being configured to capture the gripped tissue against said shaft, at least one actuating mechanism mounted to the proximal end of the shaft, and at least one connection mechanism connecting the at least one actuating mechanism to the at least one effector mechanism, whereby a user may utilize the at least one actuating mechanism to actuate the at least one effector mechanism so as to reconfigure tissue.

Abstract: Apparatus for filtering and entrapping debris in the vascular system of a patient, the apparatus including a filter to allow blood to flow therethrough and to restrict passage of debris, wherein the filter captures debris carried in a first direction of blood flow. The apparatus further includes an entrapment mechanism which allows passage of debris and blood therethrough, in the first direction of blood flow and prevents debris passage in a second direction. The entrapment mechanism and filter allow blood and debris therethrough in the first direction of blood flow. The entrapment mechanism prevents debris flow in the second direction of blood flow. A method for filtering and entrapping debris in the vascular system includes inserting the apparatus into the vascular system, allowing blood and debris carried therein to flow through the entrapment mechanism, and removing the apparatus and accumulated debris from the vascular system.

Abstract: A novel catheter-based system that ligates the left atrial appendage (LAA) on the outside of the heart, preferably using a combination of catheters and/or instruments, e.g., a guide catheter inserted into the interior of the left atrial appendage that may assist in locating the left atrial appendage and/or assist in the optimal placement of a ligature or constricting element on the outside of the appendage, and a ligating catheter and/or instrument outside the heart in the pericardial space to set the ligature or constricting element at the neck of the left atrial appendage.

Abstract: Methods for replacing native valve function of a diseased aortic valve are disclosed. In an embodiment, a method for replacing native valve function of a diseased aortic valve in a patient includes: (a) receiving an artificial heart valve assembly mounted about a first mounting position on a catheter system, (b) guiding the artificial heart valve assembly through the vasculature of the patient, (c) while the catheter system having the artificial heart valve assembly mounted thereto is in the patient's vasculature, mounting the artificial heart valve assembly about a second mounting position on the catheter system, (d) delivering the artificial heart valve assembly to the region of the diseased aortic valve, (e) expanding the artificial heart valve assembly in the region of the diseased aortic valve, and (f) withdrawing the catheter system from the patient's vasculature.

Abstract: A novel catheter-based system that ligates the left atrial appendage (LAA) on the outside of the heart, preferably using a combination of catheters and/or instruments, e.g., a guide catheter inserted into the interior of the left atrial appendage that may assist in locating the left atrial appendage and/or assist in the optimal placement of a ligature or constricting element on the outside of the appendage, and a ligating catheter and/or instrument outside the heart in the pericardial space to set the ligature or constricting element at the neck of the left atrial appendage.

Abstract: Apparatus for reconfiguring tissue, the apparatus comprising a shaft having a distal end and a proximal end; at least one effector mechanism movably mounted to the distal end of the shaft, each effector mechanism comprising at least one gripping element for gripping tissue to that effector mechanism, the at least one effector mechanism being configured to capture the gripped tissue against said shaft, at least one actuating mechanism mounted to the proximal end of the shaft, and at least one connection mechanism connecting the at least one actuating mechanism to the at least one effector mechanism, whereby a user may utilize the at least one actuating mechanism to actuate the at least one effector mechanism so as to reconfigure tissue.

Abstract: A novel catheter-based system which ligates the left atrial appendage (LAA) on the outside of the heart, preferably using a combination of catheters and/or instruments, e.g., a guide catheter positioned inside the left atrial appendage which may assist in locating the left atrial appendage and/or assist in the optimal placement of a ligature on the outside of the appendage, and a ligating catheter and/or instrument outside the heart in the pericardial space to set a ligating element at the neck of the left atrial appendage.

Abstract: A fixation band has a tubular frame and a tube, wherein the tubular frame comprises longitudinally-extending members having a hook on its distal end and fixation means on its proximal end. The tubular frame preferably comprises a laterally-extending member for stabilization. The tube is positioned inside longitudinally-extending members and a sewing cuff is formed in the tube distal to the distalmost end of the longitudinally-extending members. A standard prosthetic valve can be secured to the fixation band by suturing the prosthetic valve's sewing cuff to the fixation band's sewing cuff and the prosthetic valve can be advanced to a valve seat. By pulling the tubular frame proximally, the hooks pass into surrounding tissue so that the fixation band and prosthetic valve are fixed against proximal movement. The fixation means then secure the fixation band to the surrounding tissue so that the prosthetic valve is fixed against distal movement.

Abstract: Device and method for sub-xiphoid ablation of patient tissue. A sub-xiphoid access clamp has a handle, an elongate neck coupled to the handle and first and second opposing jaws. The first and second opposing jaws have first and second opposing relief segments being generally co-planar and concave with respect to one another to form a void therebetween, and first and second opposing elongate ablation elements positioned along the first and second opposing jaws and distal of the first and second opposing relief segments relative to the handle. The first and second opposing jaws are articulate between a closed position and an open position to admit, at least in part, a second portion of tissue of the patient within the void created by the first and second opposing relief segments while the first portion of tissue is positioned between the first and second ablation elements in the closed position.

Abstract: A novel catheter-based system which ligates the left atrial appendage (LAA) on the outside of the heart, preferably using a combination of catheters and/or instruments, e.g., a guide catheter positioned inside the left atrial appendage which may assist in locating the left atrial appendage and/or assist in the optimal placement of a ligature on the outside of the appendage, and a ligating catheter and/or instrument outside the heart in the pericardial space to set a ligating element at the neck of the left atrial appendage.

Abstract: Apparatus for filtering and entrapping debris in the vascular system of a patient, the apparatus including a filter to allow blood to flow therethrough and to restrict passage of debris, wherein the filter captures debris carried in a first direction of blood flow. The apparatus further includes an entrapment mechanism which allows passage of debris and blood therethrough, in the first direction of blood flow and prevents debris passage in a second direction. The entrapment mechanism and filter allow blood and debris therethrough in the first direction of blood flow. The entrapment mechanism prevents debris flow in the second direction of blood flow. A method for filtering and entrapping debris in the vascular system includes inserting the apparatus into the vascular system, allowing blood and debris carried therein to flow through the entrapment mechanism, and removing the apparatus and accumulated debris from the vascular system.

Abstract: Devices and methods for performing intravascular procedures without cardiac bypass include embodiments of temporary filter devices, temporary valves, and prosthetic valves. The temporary filter devices have a cannula which provides access for surgical tools for effecting repair of cardiac valves. The cannula may have filters which prevent embolitic material from entering the coronary arteries and aorta. The valve devices may also have a cannula for insertion of the valve into the aorta. The valve devices expand in the aorta to occupy the entire flow path of the vessel and operate to prevent blood flow and to permit flow through the valve. The prosthetic valves include valve fixation devices which secure the prosthetic valve to the wall of the vessel. The prosthetic valves are introduced into the vascular system in a compressed state, advanced to the site of implantation, and expanded and secured to the vessel wall.

Abstract: Methods for replacing native valve function of a diseased aortic valve are disclosed. In an embodiment, a method for replacing native valve function of a diseased aortic valve in a patient includes: (a) receiving an artificial heart valve assembly mounted about a first mounting position on a catheter system, (b) guiding the artificial heart valve assembly through the vasculature of the patient, (c) while the catheter system having the artificial heart valve assembly mounted thereto is in the patient's vasculature, mounting the artificial heart valve assembly about a second mounting position on the catheter system, (d) delivering the artificial heart valve assembly to the region of the diseased aortic valve, (e) expanding the artificial heart valve assembly in the region of the diseased aortic valve, and (f) withdrawing the catheter system from the patient's vasculature.

Abstract: A fixation band has a tubular frame and a tube, wherein the tubular frame comprises longitudinally-extending members having a hook on its distal end and fixation means on its proximal end. The tubular frame preferably comprises a laterally-extending member for stabilization. The tube is positioned inside longitudinally-extending members and a sewing cuff is formed in the tube distal to the distalmost end of the longitudinally-extending members. A standard prosthetic valve can be secured to the fixation band by suturing the prosthetic valve's sewing cuff to the fixation band's sewing cuff and the prosthetic valve can be advanced to a valve seat. By pulling the tubular frame proximally, the hooks pass into surrounding tissue so that the fixation band and prosthetic valve are fixed against proximal movement. The fixation means then secure the fixation band to the surrounding tissue so that the prosthetic valve is fixed against distal movement.

Abstract: Apparatus for filtering and entrapping debris in the vascular system of a patient, the apparatus including a filter to allow blood to flow therethrough and to restrict passage of debris, wherein the filter captures debris carried in a first direction of blood flow. The apparatus further includes an entrapment mechanism which allows passage of debris and blood therethrough, in the first direction of blood flow and prevents debris passage in a second direction. The entrapment mechanism and filter allow blood and debris therethrough in the first direction of blood flow. The entrapment mechanism prevents debris flow in the second direction of blood flow. A method for filtering and entrapping debris in the vascular system includes inserting the apparatus into the vascular system, allowing blood and debris carried therein to flow through the entrapment mechanism, and removing the apparatus and accumulated debris from the vascular system.

Abstract: Devices and methods for performing intravascular procedures without cardiac bypass include embodiments of temporary filter devices, temporary valves, and prosthetic valves. The temporary filter devices have a cannula which provides access for surgical tools for effecting repair of cardiac valves. The cannula may have filters which prevent embolitic material from entering the coronary arteries and aorta. The valve devices may also have a cannula for insertion of the valve into the aorta. The valve devices expand in the aorta to occupy the entire flow path of the vessel and operate to prevent blood flow and to permit flow through the valve. The prosthetic valves include valve fixation devices which secure the prosthetic valve to the wall of the vessel. The prosthetic valves are introduced into the vascular system in a compressed state, advanced to the site of implantation, and expanded and secured to the vessel wall.

Abstract: A fixation band for affixing a prosthetic heart valve to tissue having proximal and distal annular portions positionable relative to one another, the proximal and distal annular portions each having a proximal and distal sides, the proximal side of the distal annular portion and the distal side of the proximal annular portion being oriented toward one another, and a prosthetic heart valve being attachable to one of the distal side of the distal annular portion and the proximal side of the proximal annular portion; staples configured between the distal side of the proximal annular portion and the proximal side of the distal annular portion; and a compression device operative between the proximal and distal annular portions for selectively positioning the proximal and distal annular members toward one another for compressing the staples therebetween and deploying the staples into tissue so as to affix the prosthetic heart valve to tissue.