摘要:
Devices for, and methods of, compressing a stented prosthetic heart valve are disclosed. The method including inserting a stented prosthetic heart valve having a self-expandable stent frame into a container, initiating a cooling element in the container, transferring heat through a thermal conductor to cool an interior of the container, reducing a temperature of the self-expandable stent frame while located within the container to a critical temperature of not greater than 8° C., and compressing an outer diameter of the stented prosthetic heart valve while the stented prosthetic heart valve is at the critical temperature.
摘要:
Methods of compressing a stented prosthetic heart valve are disclosed. The method including inserting a stented prosthetic heart valve having a self-expandable stent frame into a container, initiating a cooling element in the container, transferring heat through a thermal conductor to cool an interior of the container, reducing a temperature of the self-expandable stent frame while located within the container to a critical temperature of not greater than 8° C., and compressing an outer diameter of the stented prosthetic heart valve while the stented prosthetic heart valve is at the critical temperature.
摘要:
A “dry” packaging in which a prosthetic heart valve is packaged within a container with hydrogel that can be provided in many forms. Certain embodiments include hydrogel that is preloaded with glycerol or the like. The hydrogel regulates the humidity within the container through a diffusion-driven mechanism if a gradient of humidity between the inside and the outside of the hydrogel exists. Humidity regulation is important to prevent the tissue of the valve structure from drying out. When the partially-hydrated hydrogel is present within container, which is saturated with air of a predefined humidity, the water molecules from the air will be absorbed by the hydrogel if the air humidity is high (i.e. when the thermodynamics favor hydrogel hydration) or vice versa. Various embodiments are configured to also house at least a portion of a delivery device for delivering the prosthetic heart valve.
摘要:
Methods of compressing a stented prosthetic heart valve are disclosed. The method including inserting a stented prosthetic heart valve having a self-expandable stent frame into a container, initiating a cooling element in the container, transferring heat through a thermal conductor to cool an interior of the container, reducing a temperature of the self-expandable stent frame while located within the container to a critical temperature of not greater than 8° C., and compressing an outer diameter of the stented prosthetic heart valve while the stented prosthetic heart valve is at the critical temperature.
摘要:
A “dry” packaging in which a prosthetic heart valve is packaged within a container with hydrogel that can be provided in many forms. Certain embodiments include hydrogel that is preloaded with glycerol or the like. The hydrogel regulates the humidity within the container through a diffusion-driven mechanism if a gradient of humidity between the inside and the outside of the hydrogel exists. Humidity regulation is important to prevent the tissue of the valve structure from drying out. When the partially-hydrated hydrogel is present within container, which is saturated with air of a predefined humidity, the water molecules from the air will be absorbed by the hydrogel if the air humidity is high (i.e. when the thermodynamics favor hydrogel hydration) or vice versa. Various embodiments are configured to also house at least a portion of a delivery device for delivering the prosthetic heart valve.
摘要:
Methods of compressing a stented prosthetic heart valve are disclosed. The method including inserting a stented prosthetic heart valve having a self-expandable stent frame into a container, initiating a cooling element in the container, transferring heat through a thermal conductor to cool an interior of the container, reducing a temperature of the self-expandable stent frame while located within the container to a critical temperature of not greater than 8° C., and compressing an outer diameter of the stented prosthetic heart valve while the stented prosthetic heart valve is at the critical temperature.
摘要:
A transcatheter valve prosthesis including a sealing component formed from a tissue having an altered extracellular matrix. The altered extracellular matrix includes at least one weakened connection such that the tissue is configured to swell or expand upon contact with a fluid. The altered extracellular matrix does not reduce compressibility of the tissue such that the delivery profile of the transcatheter valve prosthesis is not adversely affected. The tissue having an altered extracellular matrix transforms from a compressed state for delivery within a vasculature to an expanded state in situ when blood infiltrates or flows within the at least one weakened connection. The sealing component in the expanded state conforms to the geometry of the native valve tissue, thereby preventing paravalvular leakage at the implantation site.
摘要:
Methods of compressing a stented prosthetic heart valve are disclosed. The method including inserting a stented prosthetic heart valve having a self-expandable stent frame into a container, initiating a cooling element in the container, transferring heat through a thermal conductor to cool an interior of the container, reducing a temperature of the self-expandable stent frame while located within the container to a critical temperature of not greater than 8° C., and compressing an outer diameter of the stented prosthetic heart valve while the stented prosthetic heart valve is at the critical temperature.
摘要:
Aspects of the disclosure include sizing catheters and methods for determining the size and other physical parameters of an internal orifice or lumen. Embodiments include a sizing catheter assembly having a handle assembly and a catheter assembly including at least one catheter extending from the handle assembly. The catheter assembly also includes at least two sizers, which can be adjustably spaced from each other. Each of the sizers are configured to conform to respective portions of a lumen of a patient's anatomy. The sizing catheter is configured such that the sizers are configured to specify or determine first and second dimensions of the lumen and also distance between the sizers. The sizers can include valve leaflets or the sizing catheter can include a temporary valve. Additional aspects include software/methods of assessing and determining an appropriate implantable device that can include assessing the biomechanical interaction between the device and the anatomy.
摘要:
Methods of compressing a stented prosthetic heart valve are disclosed. The method including inserting a stented prosthetic heart valve having a self-expandable stent frame into a container, initiating a cooling element in the container, transferring heat through a thermal conductor to cool an interior of the container, reducing a temperature of the self-expandable stent frame while located within the container to a critical temperature of not greater than 8° C., and compressing an outer diameter of the stented prosthetic heart valve while the stented prosthetic heart valve is at the critical temperature.