Transcatheter Prosthetic Heart Valve Delivery Device with Stability Tube and Method
First Claim
1. A delivery device for percutaneously delivering a stented prosthetic heart valve, the prosthetic heart valve being radially self-expandable from a compressed arrangement to a normal, expanded arrangement, the delivery device comprising:
- a delivery sheath assembly defining a lumen and including a distal capsule and a proximal shaft, wherein the capsule is configured to compressively contain the prosthetic heart valve;
a handle including;
a housing defining a proximal side and a distal side,an actuator mechanism maintained by the housing and coupled to the shaft such that the shaft extends distal the distal side, wherein the actuator mechanism is configured to selectively move the shaft relative to the housing; and
an outer stability tube coupled to the housing and coaxially received over the shaft such that the shaft is slidable relative to the outer tube, wherein a distal end of the outer stability tube is proximal the capsule;
wherein the actuator mechanism is operable to transition the delivery device from a delivery state in which the capsule encompasses the prosthetic heart valve to a deployed state in which the capsule is withdrawn from the prosthetic heart valve, the shaft sliding relative to the outer stability tube and transitioning from the delivery state to the deployed state.
1 Assignment
0 Petitions
Accused Products
Abstract
A device for percutaneous delivery of a stented prosthetic. heart valve. The device includes a sheath, a handle, and an outer stability tube. The sheath includes a distal capsule and a proximal shaft. The handle has a housing maintaining an actuator mechanism that is coupled to the shaft. The actuator mechanism is configured to selectively move the shaft, and thus the capsule, relative to the housing. The stability tube is coupled to the housing and is coaxially received over the shaft such that the shaft is slidable relative to the stability tube. In a delivery state, the capsule encompasses the prosthetic valve. In a deployed state, the capsule is withdrawn from the prosthetic valve. The shaft slides relative to the stability tube in transitioning from the loaded state to the deployed state. When used with an introducer device, the stability tube frictionally isolates the sheath.
142 Citations
22 Claims
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1. A delivery device for percutaneously delivering a stented prosthetic heart valve, the prosthetic heart valve being radially self-expandable from a compressed arrangement to a normal, expanded arrangement, the delivery device comprising:
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a delivery sheath assembly defining a lumen and including a distal capsule and a proximal shaft, wherein the capsule is configured to compressively contain the prosthetic heart valve; a handle including; a housing defining a proximal side and a distal side, an actuator mechanism maintained by the housing and coupled to the shaft such that the shaft extends distal the distal side, wherein the actuator mechanism is configured to selectively move the shaft relative to the housing; and an outer stability tube coupled to the housing and coaxially received over the shaft such that the shaft is slidable relative to the outer tube, wherein a distal end of the outer stability tube is proximal the capsule; wherein the actuator mechanism is operable to transition the delivery device from a delivery state in which the capsule encompasses the prosthetic heart valve to a deployed state in which the capsule is withdrawn from the prosthetic heart valve, the shaft sliding relative to the outer stability tube and transitioning from the delivery state to the deployed state. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A system for restoring a defective heart valve of a patient, the system comprising:
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a delivery device including; an outer stability tube defining a distal end, a delivery sheath assembly defining a lumen and including a distal capsule and a proximal shaft, the shaft slidably received within the outer stability tube, a handle including; a housing defining a distal side and coupled to the outer stability tube such that the outer stability tube extends distal the distal side, an actuator mechanism maintained by the housing and coupled to the shaft such that the delivery sheath assembly extends distal the distal side and is selectively moveable relative to the outer stability tube with operation of the actuator mechanism; and a prosthetic heart valve having a stent frame and a valve structure attached to the frame and forming at least two valve leaflets, the prosthetic heart valve being self-expandable from a compressed arrangement to a natural arrangement; wherein the system is configured to be transitionable from a loaded condition in which the prosthetic heart valve is retained within the capsule and deployed condition in which the capsule is withdrawn from the prosthetic heart valve to permit the prosthetic heart valve to self-expand to the natural arrangement and release from the delivery device, the actuator mechanism being configured to effectuate transitioning from the loaded condition to the deployed condition by sliding the delivery sheath assembly relative to the prosthetic heart valve and the stability tube. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17, 18)
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19. A method for restoring a defective heart valve of a patient, the method comprising:
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receiving a delivery device loaded with a radially expandable prosthetic heart valve having a stent frame to which a valve structure is attached, the delivery device including a delivery sheath containing the prosthetic heart valve in a compressed arrangement and an outer stability tube coaxially received over the delivery sheath and terminating proximal the prosthetic heart valve in a delivery state of the delivery device; establishing an access portal to a bodily lumen of the patient with an introducer device including an introducer sheath and a valve; inserting the prosthetic heart valve into the bodily lumen through the introducer valve while the prosthetic heart valve is constrained within the delivery sheath, including hemostasis being established between the introducer valve and the outer stability tube; manipulating the delivery system to guide the prosthetic heart valve through the patient'"'"'s vasculature and into the defective heart valve; and withdrawing the delivery sheath from the prosthetic heart valve, including the delivery sheath sliding relative to the outer stability tube to release the prosthetic heart valve from the delivery sheath and permitting the prosthetic heart valve to self-expand into engagement with the native heart valve. - View Dependent Claims (20, 21, 22)
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Specification