Abstract: A silicone prosthesis delivery apparatus and associated methods are disclosed for facilitating the transport and subsequent insertion of a silicone prosthesis into a surgically developed pocket of a patient. In at least one embodiment, a flexible, substantially funnel-shaped delivery sleeve is constructed out of a material having a lubricating additive that forms a textured inner surface within the delivery sleeve. An entry portion of the delivery sleeve defines a stretchable entry opening configured for allowing the prosthesis to pass therethrough to a position inside the delivery sleeve. An opposing exit portion defines a stretchable exit opening configured for allowing the prosthesis to pass therethrough when the prosthesis is subsequently expelled from the delivery sleeve. A volume of surgical lubricating fluid coats the textured inner surface of the delivery sleeve so as to reduce the coefficient of friction between the inner surface of the delivery sleeve and the prosthesis.

Abstract: A silicone prosthesis delivery apparatus and associated methods are disclosed for facilitating the transport and subsequent insertion of a silicone prosthesis into a surgically developed pocket of a patient. In at least one embodiment, a flexible, substantially funnel-shaped delivery sleeve is configured for receiving and subsequently expelling the prosthesis therefrom. The delivery sleeve provides a substantially conical-shaped entry portion and a substantially conical-shaped exit portion, the entry portion and exit portion opposingly positioned and joined with one another so as to form a relatively larger diameter middle section. A tapered free end of the entry portion provides an entry opening configured for allowing the prosthesis to selectively pass therethrough when the prosthesis is inserted into the delivery sleeve.

Abstract: A silicone prosthesis delivery apparatus and associated methods are disclosed for facilitating the insertion of a silicone prosthesis into a surgically developed pocket of a patient. In at least one embodiment, a flexible, substantially hourglass-shaped delivery sleeve is configured for receiving and subsequently expelling the prosthesis therefrom. The delivery sleeve provides a substantially conical-shaped transfer channel and a substantially conical-shaped delivery chamber, the transfer channel and delivery chamber opposingly positioned and joined with one another so as to form a relatively smaller diameter passage therebetween. A free end of the transfer channel provides an entry opening configured for allowing the prosthesis to selectively pass therethrough when the prosthesis is inserted into the delivery sleeve, and a free end of the delivery chamber provides a closed end.

Abstract: A silicone prosthesis delivery apparatus and associated methods are disclosed for facilitating the transport and subsequent insertion of a silicone prosthesis into a surgically developed pocket of a patient. In at least one embodiment, a flexible, substantially funnel-shaped delivery sleeve is configured for receiving and subsequently expelling the prosthesis therefrom. The delivery sleeve provides a substantially conical-shaped entry portion and a substantially conical-shaped exit portion, the entry portion and exit portion opposingly positioned and joined with one another so as to form a relatively larger diameter middle section. A tapered free end of the entry portion provides an entry opening configured for allowing the prosthesis to selectively pass therethrough when the prosthesis is inserted into the delivery sleeve.

Abstract: An assembly includes an expandable prosthetic heart valve, a catheter shaft, and a stabilization device. The expandable prosthetic heart valve has a valve body and a plurality of leaflets coupled to the valve body. The catheter shaft has a proximal end portion and a distal end portion. The prosthetic heart valve is coupled to the distal end portion of the catheter shaft. The stabilization device is coupled to the catheter shaft adjacent the prosthetic heart valve and is movable between a contracted configuration and an expanded configuration. In the expanded configuration, the stabilization device is configured to contact surrounding tissue adjacent a site of implantation to stabilize the catheter shaft relative to the site of implantation while the prosthetic heart valve is radially expanded from a radially-compressed state to a radially-expanded state at the site of implantation.

Abstract: The invention provides systems and methods for sternum repair. A sternum repair device may include a central body, which may include a plurality of bands and buckles, such that a band extends from the central body and is received by a buckle component. The band may wrap around the sternum and the device may be tightened to keep the separate sternum pieces together.

Abstract: The invention provides systems and methods for sternum repair. A sternum repair device may include a central body, which may include a plurality of bands and buckles, such that a band extends from the central body and is received by a buckle component. The band may wrap around the sternum and the device may be tightened to keep the separate sternum pieces together.

Abstract: A method for delivering and deploying a self-expandable heart valve to a site of implantation such as the aortic annulus. The deployment step may include engaging an outer surface of the heart valve with a plurality of distal fingers and a plurality of proximal fingers. Controlled radial movement of the fingers regulates the expansion of the heart valve. The fingers may be removed prior to inflation of a balloon to fully expand the valve, or the fingers may be repositioned to the inside of the valve for this purpose. The deployment step may include an umbrella structure that forces the valve outward into its fully expanded configuration. Alternatively, a gear shaft that engages one or more gear tracks on the valve may be utilized to regulate expansion of the valve. A stabilization balloon may be used to axially and radially locate the deployment mechanism relative to the site of implantation.

Abstract: A method for replacing native valve function of a diseased aortic valve in a patient is provided. The method comprises: (a) guiding a catheter system having a balloon through the vasculature of the patient; (b) guiding an artificial heart valve assembly through the vasculature of the patient; (c) while the catheter system is in the patient's vasculature, positioning the artificial heart valve assembly about the balloon of the catheter system; (d) delivering the artificial heart valve assembly to the region of the diseased aortic valve; (e) while the patient's heart is beating, 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: Methods and devices for driving a suture assembly employing elastically pre-shaped needles for piercing a tissue. The pre-shaped needles are held in a constrained state and can revert to a natural pre-shaped state prior to or during ejection from the device before entry into tissue allowing for the suture to follow a defined path similar to the pre-shaped needle such that removal of the needle allows for subsequent securing of the suture in or around tissue.

Abstract: A system for delivering and deploying a self-expandable heart valve to a site of implantation such as the aortic annulus includes a deployment mechanism that engages the valve and regulates the rate of expansion of both the proximal and distal ends thereof. The heart valve may be a rolled-type valve and the deployment mechanism may include a plurality of distal fingers and a plurality of proximal fingers that engage the outer layer of the head valve. Controlled radial movement of the fingers regulates the unwinding of the rolled heart valve. The fingers may be removed prior to inflation of a balloon to fully expand the valve, or the fingers may be repositioned to the inside of the valve for this purpose. The deployment mechanism may include an umbrella structure that forces the rolled valve outward into its fully expanded configuration. Alternatively, a gear shaft that engages one or more gear tracks on the valve may be utilized to regulate expansion of the valve.

Abstract: A system for delivering and deploying a self-expandable heart valve includes a deployment mechanism that engages the valve and regulates the rate of expansion of both the proximal and distal ends thereof. The deployment mechanism may include a plurality of distal fingers and a plurality of proximal fingers that engage the end portions of the heart valve. Controlled radial movement of the fingers regulates the expansion of the heart valve such that the proximal and distal ends radially expand at the same rate. A stabilization balloon may be used to axially and radially locate the deployment mechanism relative to the site of implantation. Methods of operation of the delivery and deployment mechanism include regulating the rate of self-expansion of the valve and forcing the valve outward into its fully expanded configuration utilizing the same or different means.

Abstract: A system for delivering and deploying a self-expandable heart valve to a site of implantation such as the aortic annulus includes a deployment mechanism that engages the valve and regulates the rate of expansion of both the proximal and distal ends thereof. The heart valve may be a rolled-type valve and the deployment mechanism may include a plurality of distal fingers and a plurality of proximal fingers that engage the outer layer of the heart valve. Controlled radial movement of the fingers regulates the unwinding of the rolled heart valve. The fingers may be removed prior to inflation of a balloon to fully expand the valve, or the fingers may be repositioned to the inside of the valve for this purpose. The deployment mechanism may include an umbrella structure that forces the rolled valve outward into its fully expanded configuration. Alternatively, a gear shaft that engages one or more gear tracks on the valve may be utilized to regulate expansion of the valve.