Abstract: An aortic root replacement device is movable between a deployed configuration and a retracted configuration. The device includes an intraventricular stent having a proximal portion and a distal portion, the intraventricular stent is flared from the proximal portion towards the distal portion such that when the device is deployed in the ventricle below the aortic valve it is held in position in the ventricle. The device also includes—an aortic valve unit and an aortic stent extending from the intraventricular stent. The intraventricular stent, the aortic valve unit and the aortic stent form a unitary assembly in retracted configuration and in deployed configuration, the aortic stent includes at least three means for connecting the device to the coronary arteries.

Abstract: Methods and apparatuses to place a prosthesis within a receiving structure are provided. A delivery apparatus includes an elongated support member including a support member distal end. A stop cap is disposed at the support member distal end and includes a stop cap transverse dimension larger than an inner diameter of a receiving lumen of the receiving structure. An elongated prosthesis-positioning member extends along the support member and stop cap so a distal surface of the prosthesis-positioning member is disposed at a position longitudinally coincident with a portion of the stop cap. A sheath comprises a sheath lumen receiving the prosthesis-positioning member so the sheath translates longitudinally relative to the prosthesis-positioning member. The delivery apparatus has a loaded configuration in which the prosthesis is received in the sheath lumen with a proximal end of the prosthesis abutting the prosthesis-positioning member distal surface.

Abstract: Prostheses and methods of making the same are provided. The prosthesis has an internal branch configuration. A trough or branch opening is at least partially defined by a trough wall extending into a main lumen from a sidewall of the prosthesis. The internal branch extends from the trough within the main lumen towards one of the outflow end of the graft body in a helical, retrograde arrangement. Other arrangements are described. The prosthesis may include a scalloped fenestration having a width larger than the trough. The trough may be positioned along a tapered region of the prosthesis. The trough and internal branch may be made from the same graft material. The trough and internal branch, in addition to the main graft body, may be made from the same graft material.

Abstract: Systems and methods to place a prosthesis to have a preselected overlap with a receiving structure are provided. In one embodiment, a delivery system may include a primary sheath comprising a primary sheath lumen. The delivery system may further include a secondary sheath comprising a secondary sheath lumen. The primary sheath may be at least partially received within the secondary sheath lumen such that the primary sheath may translate longitudinally within the secondary sheath lumen. The delivery system may further include a prosthesis having proximal and distal ends and being received within the primary sheath lumen adjacent to the primary sheath distal end in a contracted delivery state. The delivery system may further include a length reference mechanism that indicates a length of the primary sheath distal end that extends distal to the secondary sheath distal end during the contracted delivery state of the prosthesis.

Abstract: The invention relates to a method for producing a vascular endoprosthesis for insertion into a natural cavity of a person's body. The method is based on a three-dimensional model including a main channel, at least one branch of the channel extending from the main channel, and an intersection between the main channel and the branch of the channel. The method includes producing an imprint structure which is designed to follow a shape of the main channel, the imprint structure comprising at least one location corresponding to the intersection of the three-dimensional model, placing a reinforcement at the location of the imprint structure, producing a prosthesis wall using the imprint structure, the prosthesis wall being made of polymer, a window or a branch of the prosthesis being produced at the location, producing the vascular endoprosthesis including the window or branch of the prosthesis.

Abstract: An endoluminal prosthesis system for being deployed in a patient's aorta near the heart includes a graft having a tubular body with a lumen extending from proximal end configured to be deployed near a patient's heart to a distal end configured to be deployed away from the patient's heart. A collar around the graft is sized and configured to be sutured to a patient's aorta. Passageways in the middle portion of the graft permit fluid communication from the lumen of the graft to an exterior of the graft. A respective bridging branch is disposed at each of the passageways, each of the bridging branches having an inner opening and an outer opening so that the bridging branches provide fluid communication from the lumen of the graft to the exterior of the graft. A respective bridging graft is sized and arranged to mate with each of the bridging branches.

Abstract: A pre-loaded delivery device that facilitates accurate placement of a stent graft assembly in the aorta is disclosed. A stent graft is carried on the delivery device and held in a pre-deployment configuration by a sheath. A split in the sheath facilitates the pre-cannulation of one or more branch arteries extending from the aorta before the stent graft is fully released in the aorta. The stent graft comprises a tubular body having at least one scalloped fenestration formed in one end of the graft material and at least one fenestration formed in the graft material of the main tubular body. A helical internal side branch extends from the fenestration within the lumen of the main tubular body. The helical side branch is configured to curve at least partially around the scalloped fenestration. The assembly further comprises a connection stent graft extending from the fenestration into a branch vessel.

Abstract: Systems and methods to place a prosthesis to have a preselected overlap with a receiving structure are provided. In one embodiment, a delivery system may include a primary sheath comprising a primary sheath lumen. The delivery system may further include a secondary sheath comprising a secondary sheath lumen. The primary sheath may be at least partially received within the secondary sheath lumen such that the primary sheath may translate longitudinally within the secondary sheath lumen. The delivery system may further include a prosthesis having proximal and distal ends and being received within the primary sheath lumen adjacent to the primary sheath distal end in a contracted delivery state. The delivery system may further include a length reference mechanism that indicates a length of the primary sheath distal end that extends distal to the secondary sheath distal end during the contracted delivery state of the prosthesis.

Abstract: Methods and apparatuses to place a prosthesis within a receiving structure are provided. A delivery apparatus includes an elongated support member including a support member distal end. A stop cap is disposed at the support member distal end and includes a stop cap transverse dimension larger than an inner diameter of a receiving lumen of the receiving structure. An elongated prosthesis-positioning member extends along the support member and stop cap so a distal surface of the prosthesis-positioning member is disposed at a position longitudinally coincident with a portion of the stop cap. A sheath comprises a sheath lumen receiving the prosthesis-positioning member so the sheath translates longitudinally relative to the prosthesis-positioning member. The delivery apparatus has a loaded configuration in which the prosthesis is received in the sheath lumen with a proximal end of the prosthesis abutting the prosthesis-positioning member distal surface.

Abstract: In the present invention, an imaging system and method is provided to obtain a fusion image of a patient anatomy used as a navigational 3D roadmap to guide an interventional device into the anatomy. The fusion image fuses in real-time, fluoroscopy images taken during the interventional procedure with pre-operative CTA images, so that the operator can see the anatomy in the fluoroscopy image without having to inject contrast agent. To correct for the deformation in the anatomy from the pre-op CTA images form the insertion of interventional devices during the procedure, a 3D ultrasound image is obtained after the insertion of the devices. The 3D ultrasound images are then utilized to correct the pre-op CTA images and provide the current vascular anatomy of the patient. This updated CTA image is fused with the intra-op fluoro images to provide an accurate 3D roadmap image that matches the deformed anatomy.

Abstract: An endoluminal prosthesis system for being deployed in a patient's aorta near the heart includes a graft having a tubular body with a lumen extending from proximal end configured to be deployed near a patient's heart to a distal end configured to be deployed away from the patient's heart. A collar around the graft is sized and configured to be sutured to a patient's aorta. Passageways in the middle portion of the graft permit fluid communication from the lumen of the graft to an exterior of the graft. A respective bridging branch is disposed at each of the passageways, each of the bridging branches having an inner opening and an outer opening so that the bridging branches provide fluid communication from the lumen of the graft to the exterior of the graft. A respective bridging graft is sized and arranged to mate with each of the bridging branches.

Abstract: An introducer for an endoluminal prosthesis and a methods for delivering a prosthesis within a body vessel are described. The introducer comprises pusher catheter having a lumen extending therethrough, the lumen being in communication with an opening formed in the sidewall of the pusher. A sheath is disposed over the pusher catheter and also has an opening formed in its sidewall. The sheath is longitudinally movable relative to the pusher catheter between a prosthesis delivery position and a prosthesis deployment position. When the sheath is in the deployment position, the opening formed in the sidewall of the pusher catheter is at least partially longitudinally aligned with the opening formed in the sidewall of the sheath. A wire may extend though the opening in the sheath, the opening in the pusher, through the lumen of the pusher and through a fenestration in a prosthesis to cannulate a branch vessel.

Abstract: A pre-loaded prosthesis delivery device is described. In one example, the prosthesis delivery device is pre-loaded with a single wire that allows the device to be tracked into place within a vessel and also facilitates cannulation of a branch vessel. The delivery device further comprises a prosthesis that is releasably coupled to a delivery catheter by using two attachment wires to secure the proximal end of the prosthesis to the delivery device in a tri-fold configuration.

Abstract: Prostheses and methods of making the same are provided. The prosthesis has an internal branch configuration. A trough or branch opening is at least partially defined by a trough wall extending into a main lumen from a sidewall of the prosthesis. The internal branch extends from the trough within the main lumen towards one of the outflow end of the graft body in a helical, retrograde arrangement. Other arrangements are described. The prosthesis may include a scalloped fenestration having a width larger than the trough. The trough may be positioned along a tapered region of the prosthesis. The trough and internal branch may be made from the same graft material. The trough and internal branch, in addition to the main graft body, may be made from the same graft material.

Abstract: A pre-loaded prosthesis delivery device is described. In one example, the prosthesis delivery device is pre-loaded with a single wire that allows the device to be tracked into place within a vessel and also facilitates cannulation of a branch vessel. The delivery device further comprises a prosthesis that is releasably coupled to a delivery catheter by using two attachment wires to secure the proximal end of the prosthesis to the delivery device in a tri-fold configuration.

Abstract: An introducer for an endoluminal prosthesis and a methods for delivering a prosthesis within a body vessel are described. The introducer comprises pusher catheter having a lumen extending therethrough, the lumen being in communication with an opening formed in the sidewall of the pusher. A sheath is disposed over the pusher catheter and also has an opening formed in its sidewall. The sheath is longitudinally movable relative to the pusher catheter between a prosthesis delivery position and a prosthesis deployment position. When the sheath is in the deployment position, the opening formed in the sidewall of the pusher catheter is at least partially longitudinally aligned with the opening formed in the sidewall of the sheath. A wire may extend though the opening in the sheath, the opening in the pusher, through the lumen of the pusher and through a fenestration in a prosthesis to cannulate a branch vessel.

Abstract: A pre-loaded delivery device that facilitates accurate placement of a stent graft assembly in the aorta is disclosed. A stent graft is carried on the delivery device and held in a pre-deployment configuration by a sheath. A split in the sheath facilitates the pre-cannulation of one or more branch arteries extending from the aorta before the stent graft is fully released in the aorta. The stent graft comprises a tubular body having at least one scalloped fenestration formed in one end of the graft material and at least one fenestration formed in the graft material of the main tubular body. A helical internal side branch extends from the fenestration within the lumen of the main tubular body. The helical side branch is configured to curve at least partially around the scalloped fenestration. The assembly further comprises a connection stent graft extending from the fenestration into a branch vessel.

Abstract: A method for preparing a biomaterial containing at least one bioactive molecule from a base biomaterial, comprising the following successive operations carried out on the base biomaterial: a) application of a solid mixture of: cyclodextrin(s) and/or cyclodextrin derivative(s) and/or cyclodextrin inclusion complex(es) and/or cyclodextrin derivative inclusion complex(es), at least one poly(carboxylic) acid, and optionally a catalyst; b) heating at a temperature between 100° C. and 200° C. for a period of 1 to 60 minutes; c) washing with water; d) drying, wherein at least one bioactive agent is incorporated in the biomaterial by impregnation of the biomaterial after the drying step in a concentrated solution of the bioactive agent.

Abstract: The present invention relates to a method of preparation of a biomaterial containing at least one bioactive molecule from a base biomaterial, characterized by the following successive operations carried out on the aforesaid base biomaterial: a) application of a solid mixture of: cyclodextrin(s) and/or cyclodextrin derivative(s) and/or cyclodextrin inclusion complex(es) and/or cyclodextrin derivative inclusion complex(es), at least one poly(carboxylic) acid, and optionally a catalyst; b) heating at a temperature between 100° C. and 220° C. for a period of 1 to 60 minutes; c) washing with water; d) drying, and wherein at least one bioactive agent is incorporated in the biomaterial by impregnation of the biomaterial after the drying step in a concentrated solution of bioactive agent.