Transcatheter Prosthetic Heart Valve Delivery System and Method With Stretchable Stability Tube
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:
- an inner shaft assembly including a coupling structure configured to selectively engage a prosthetic heart valve;
a delivery sheath assembly slidably disposed over the inner shaft assembly and including a distal capsule and a proximal shaft, wherein the capsule is configured to compressively contain the prosthetic heart valve in a compressed arrangement;
an outer stability tube coaxially received over the shaft, the stability tube including a proximal region and a distal region;
wherein a circumferential rigidity of the capsule is greater than a circumferential rigidity of the distal region; and
a handle maintaining the inner shaft assembly, the delivery sheath assembly, and the stability tube, the handling including;
a housing,an actuator mechanism maintained by the housing and coupled to the shaft, wherein the actuator mechanism is operable to selectively move the delivery sheath assembly relative to the inner shaft assembly and the delivery tube;
wherein the delivery device is configured to provide;
a delivery state in which the capsule compressively contains the prosthetic heart valve and the distal region of the stability tube is proximal the capsule, an inner diameter of the distal region being less than an outer diameter of the capsule in the delivery state,a deployed state in which the capsule is withdrawn from the prosthetic heart valve and at least partially into the distal region to permit the prosthetic heart valve to self-deploy, wherein the capsule forces the distal region to expand in diameter upon placement within the distal region.
1 Assignment
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Accused Products
Abstract
A device for percutaneously delivering a stented prosthetic heart valve. The device includes an inner shaft, a delivery sheath, stability tube, and a handle. The delivery sheath is slidably disposed over the inner shaft, and includes a capsule compressively containing the prosthesis over the inner shaft. The stability tube is coaxially received over the delivery sheath, and includes a distal region. A circumferential rigidity of the capsule is greater than a circumferential rigidity of the distal region. In transitioning from a delivery state to a deployed state, the capsule is withdrawn from the prosthetic heart valve and at least partially into the distal region to permit the prosthesis to self-deploy. The capsule forces the distal region to stretch and expand in diameter.
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Citations
33 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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an inner shaft assembly including a coupling structure configured to selectively engage a prosthetic heart valve; a delivery sheath assembly slidably disposed over the inner shaft assembly and including a distal capsule and a proximal shaft, wherein the capsule is configured to compressively contain the prosthetic heart valve in a compressed arrangement; an outer stability tube coaxially received over the shaft, the stability tube including a proximal region and a distal region; wherein a circumferential rigidity of the capsule is greater than a circumferential rigidity of the distal region; and a handle maintaining the inner shaft assembly, the delivery sheath assembly, and the stability tube, the handling including; a housing, an actuator mechanism maintained by the housing and coupled to the shaft, wherein the actuator mechanism is operable to selectively move the delivery sheath assembly relative to the inner shaft assembly and the delivery tube; wherein the delivery device is configured to provide; a delivery state in which the capsule compressively contains the prosthetic heart valve and the distal region of the stability tube is proximal the capsule, an inner diameter of the distal region being less than an outer diameter of the capsule in the delivery state, a deployed state in which the capsule is withdrawn from the prosthetic heart valve and at least partially into the distal region to permit the prosthetic heart valve to self-deploy, wherein the capsule forces the distal region to expand in diameter upon placement within the distal region. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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16. A system for repairing a defective heart valve of a patient, the system comprising:
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a prosthetic heart valve including a stent frame and a valve structure attached to the frame and forming at least two valve leaflets, the prosthetic heart valve being radially self-expandable from a compressed arrangement to a normal, expanded arrangement; and a delivery device comprising; an inner shaft assembly including a coupling structure configured to selectively engage the prosthetic heart valve, a delivery sheath assembly slidably disposed over the inner shaft assembly and including a distal capsule and a proximal shaft, wherein the capsule is configured to compressively contain the prosthetic heart valve in the compressed arrangement, an outer stability tube coaxially received over the shaft such that the shaft is slidable relative to the stability tube, the stability tube including a proximal region and a distal region terminating at a distal end, wherein a circumferential rigidity of the capsule is greater than a circumferential rigidity of the distal region, a handle maintaining the inner shaft assembly, the delivery sheath assembly and the stability tube, the handle including; a housing, an actuator mechanism maintained by the housing and coupled to the shaft, wherein the actuator mechanism is operable to selectively move the delivery sheath assembly relative to the inner shaft assembly and the delivery tube; wherein the system is configured to provide; a loaded condition in which the capsule compressively contains the prosthetic heart valve over the inner shaft assembly in the compressed arrangement, the distal end of the stability tube located immediately proximal the capsule, and the distal region defining an inner diameter that is less than an outer diameter of the capsule, a deployed condition in which the capsule is retracted from the prosthetic heart valve to permit the prosthetic heart valve to self-deploy toward the normal arrangement and release from the delivery device, wherein the system transitions from the loaded condition to the deployed condition by proximally sliding the delivery sheath assembly relative to the inner shaft assembly and the stability tube, including the capsule at least partially sliding within the distal region and forcing the distal region to expand in diameter. - View Dependent Claims (17, 18, 19, 20, 21, 22, 23, 24, 25)
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26. A method of repairing a defective heart valve of a patient, the method comprising:
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receiving a delivery device in a delivery state and loaded with a radially self-expandable prosthetic heart valve having a stent frame to which a valve structure is attached, the delivery device including a delivery sheath having a capsule extending distally from a shaft and containing the prosthetic heart valve in a compressed arrangement, and an outer stability tube coaxially received over the delivery sheath, the stability tube including a distal region terminating at a distal end; delivering the prosthetic heart valve in the compressed arrangement through a bodily lumen of the patient to an implantation site of the defective heart valve via the delivery device; arranging the distal end of the stability tube immediately proximal the capsule, wherein prior to transitioning of the delivery device from the delivery state, the distal region has an inner diameter that is less than an outer diameter of the capsule; and proximally retracting the capsule from over the prosthetic heart valve and at least partially into the distal region such that the prosthetic heart valve self-deploys from the delivery device and implants within the defective heart valve; wherein upon retraction of the capsule into the distal region, the capsule forces the distal region to expand in diameter. - View Dependent Claims (27, 28, 29, 30, 31, 32, 33)
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Specification