Abstract: A device for suturing tissue includes a handle that has a proximal end and a distal end. The device also includes a generally hollow suturing needle including a pointed distal end, an opposite proximal end and an inner lumen having an suture exit port through which the suture exits. The device further includes a suture dispensing mechanism disposed within the handle and including an actuator which when manipulated by a user is configured to advance suture material within the handle such that the suture material is guided into the inner lumen of the hollow suturing needle and exits through the suture exit port. The device includes a safety mechanism that shields at least a portion of the needle.

Abstract: Devices and method are disclosed for reducing pressure in a patient's vena cava and in the right atrium of a patient's heart. A valve is implanted in the inferior vena cava (IFC) between the patient's renal veins and hepatic veins. When pressure in a patient's IFC reaches high levels, i.e., the pressure differential across the valve reaches high levels, the valve automatically closes or begins to close. The closing is caused by the pressure of the patient's blood moving one or more flaps in the valve to a closed or near-closed position. This prevents excessive pressure in the upper or superior vena cava and the right atrium of the patient's heart. The device also includes a pressure relief feature that opens and allows retrograde flow of blood if the pressure differential exceeds a yet higher pressure.

Abstract: Devices and methods for treating heart disease by normalizing elevated blood pressure in the left and right atria of a heart of a mammal are disclosed. Devices may include an adjustable hydraulic diameter and/or a removable and/or replaceable shunt portion. Devices may include absorbable materials, the absorption of which directly or indirectly causes alterations of the fluid flow capacities the devices.

Abstract: A suturing device of the present invention is in the form a compact, light-weight handheld device that includes a needle and suture assembly, a mechanism for gripping and releasing the needle/suture (a “needle transfer mechanism” or “needle shuttle mechanism”), safely capturing the needle/suture upon exit from the patient's tissue, and returning the needle to a position such that the process of delivering additional sutures to the patient can be repeated. A safety shield mechanism ensures the user is protected from the needle at all times. The device of the present invention accommodates the right or left-handed user, rests comfortably in the user's hand, allows sufficient visualization of the procedure site, and permits the user to either control penetration depth of the needle or default to a device-determined depth. The present device permits the user to utilize a wrist-rotation (pivoting) suture delivery technique.

Abstract: Devices and methods for treating heart disease by normalizing elevated blood pressure in the left and right atria of a heart of a mammal are disclosed. Devices may include an adjustable hydraulic diameter and/or a removable and/or replaceable shunt portion. Devices may include absorbable materials, the absorption of which directly or indirectly causes alterations of the fluid flow capacities the devices.

Abstract: A suturing device of the present invention is in the form a compact, light-weight handheld device that includes a needle and suture assembly, a mechanism for gripping and releasing the needle/suture (a “needle transfer mechanism” or “needle shuttle mechanism”), safely capturing the needle/suture upon exit from the patient's tissue, and returning the needle to a position such that the process of delivering additional sutures to the patient can be repeated. A safety shield mechanism ensures the user is protected from the needle at all times. The device of the present invention accommodates the right or left-handed user, rests comfortably in the user's hand, allows sufficient visualization of the procedure site, and permits the user to either control penetration depth of the needle or default to a device-determined depth. The present device permits the user to utilize a wrist-rotation (pivoting) suture delivery technique.

Abstract: Devices and methods for treating heart disease by normalizing elevated blood pressure in the left and right atria of a heart of a mammal are disclosed. Devices may include an adjustable hydraulic diameter shunt portion which can be manually adjusted in vivo. Methods are provided for adjusting the flow rate of the devices in vivo.

Abstract: A tissue anchoring system includes a tissue anchor member that is suitable for anchoring against tissue. The system also includes a tensioning member operatively connected to the anchor member such that the anchor member can slide relative to the tensioning member, the tensioning member capable of being pulled to cause the anchor member to move relative to the tensioning member into a position seated against the tissue. A hand operated deployment catheter is operable to extend and deploy the anchor member therefrom. The deployment catheter includes a rotatable member about which the tensioning member is routed and a clutch assembly for limiting tension within the tensioning member to prevent the deployed anchor from being pulled through the tissue.

Abstract: A tissue anchoring system includes a tissue anchor member that is suitable for anchoring against tissue. The system also includes a tensioning member operatively connected to the anchor member such that the anchor member can slide relative to the tensioning member, the tensioning member capable of being pulled to cause the anchor member to move relative to the tensioning member into a position seated against the tissue. A hand operated deployment catheter is operable to extend and deploy the anchor member therefrom. The deployment catheter includes a rotatable member about which the tensioning member is routed and a clutch assembly for limiting tension within the tensioning member to prevent the deployed anchor from being pulled through the tissue.

Abstract: Devices and methods for treating heart disease by normalizing elevated blood pressure in the left and right atria of a heart of a mammal are disclosed. Devices may include an adjustable hydraulic diameter shunt portion which can be manually adjusted in vivo. Methods are provided for adjusting the flow rate of the devices in vivo.

Abstract: The present disclosure relates to a method and a device for treating heart failure by normalizing elevated blood pressure in the left and right atria of a heart of a mammal The present disclosure includes methods for creating and maintaining an opening in the atrial septum. Tools for making an opening and enlarging the opening are also disclosed. Use of the techniques and tools described herein prolongs the patency of an intra-atrial pressure relief opening.

Abstract: A device according to one exemplary embodiment is a compact, light-weight handheld device that includes a needle and suture assembly, a mechanism for gripping and releasing the needle and suture assembly (a “needle transfer mechanism” or “needle shuttle mechanism”), safely capturing the needle assembly upon exit from the patient's tissue, and returning the needle to position such that the process of delivering additional sutures to the patient can be repeated. The device of the present invention accommodates the right or left-handed user, rests comfortably in the user's hand, allows sufficient visualization of the procedure site, and permits the user to either control penetration depth of the needle or default to a device-determined depth. The present device permits the user to utilize a wrist-rotation (pivoting) suture delivery technique that is familiar to a user based on experience with other surgical techniques.

Abstract: The present disclosure relates to a method and a device for treating heart failure by normalizing elevated blood pressure in the left and right atria of a heart of a mammal. The present disclosure includes methods for creating and maintaining an opening in the atrial septum. Tools for making an opening and enlarging the opening are also disclosed. Use of the techniques and tools described herein prolongs the patency of an intra-atrial pressure relief opening.

Abstract: A device for suturing tissue includes a handle that has a proximal end and a distal end. The device also includes a generally hollow suturing needle including a pointed distal end, an opposite proximal end and an inner lumen having an suture exit port through which the suture exits. The device further includes a suture dispensing mechanism disposed within the handle and including an actuator which when manipulated by a user is configured to advance suture material within the handle such that the suture material is guided into the inner lumen of the hollow suturing needle and exits through the suture exit port. The device includes a safety mechanism that shields at least a portion of the needle.

Abstract: A suturing device of the present invention is in the form a compact, light-weight handheld device that includes a needle and suture assembly, a mechanism for gripping and releasing the needle/suture (a “needle transfer mechanism” or “needle shuttle mechanism”), safely capturing the needle/suture upon exit from the patient's tissue, and returning the needle to a position such that the process of delivering additional sutures to the patient can be repeated. A safety shield mechanism ensures the user is protected from the needle at all times. The device of the present invention accommodates the right or left-handed user, rests comfortably in the user's hand, allows sufficient visualization of the procedure site, and permits the user to either control penetration depth of the needle or default to a device-determined depth. The present device permits the user to utilize a wrist-rotation (pivoting) suture delivery technique.

Abstract: The present disclosure relates to a method and a device for treating heart failure by normalizing elevated blood pressure in the left and right atria of a heart of a mammal The present disclosure includes methods for creating and maintaining an opening in the atrial septum. Tools for making an opening and enlarging the opening are also disclosed. Use of the techniques and tools described herein prolongs the patency of an intra-atrial pressure relief opening.

Abstract: A tissue anchoring system includes a tissue anchor member that is suitable for anchoring against tissue. The system also includes a tensioning member operatively connected to the anchor member such that the anchor member can slide relative to the tensioning member, the tensioning member capable of being pulled to cause the anchor member to move relative to the tensioning member into a position seated against the tissue. A hand operated deployment catheter is operable to extend and deploy the anchor member therefrom. The deployment catheter includes a rotatable member about which the tensioning member is routed and a clutch assembly for limiting tension within the tensioning member to prevent the deployed anchor from being pulled through the tissue.

Abstract: Devices and method are disclosed for reducing pressure in a patient's vena cava and in the right atrium of a patient's heart. A valve is implanted in the inferior vena cava (IFC) between the patient's renal veins and hepatic veins. When pressure in a patient's IFC reaches high levels, i.e., the pressure differential across the valve reaches high levels, the valve automatically closes or begins to close. The closing is caused by the pressure of the patient's blood moving one or more flaps in the valve to a closed or near-closed position. This prevents excessive pressure in the upper or superior vena cava and the right atrium of the patient's heart. The device also includes a pressure relief feature that opens and allows retrograde flow of blood if the pressure differential exceeds a yet higher pressure.