Balloon expandable crush-recoverable stent device
First Claim
Patent Images
1. A balloon expandable crush-recoverable stent, comprising:
- at least two radial elements arranged to form a tubular member, the radial elements being slidably interconnected for allowing the tubular member to expand from a collapsed diameter to an expanded diameter, at least one radial element comprising;
a locking mechanism for maintaining the tubular member in the expanded diameter after deployment, the locking mechanism comprising a plurality of teeth disposed on a first deflectable member that extends from a first end of the at least one radial element to a second end thereof, the locking mechanism further comprising a locking tab disposed at the first end of the at least one radial element; and
a constraining mechanism integrated into the at least one radial element for maintaining the tubular member in the collapsed diameter until released by radial expansion, the constraining mechanism comprising at least one recess disposed on a first containment member that extends from the first end of the at least one radial element to the second end thereof, the constraining mechanism further comprising a hold-down tab disposed at the second end of the at least one radial element;
wherein the radial elements are fabricated from a shape-memory material for providing crush-recoverability.
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Abstract
An intraluminal, balloon expandable stent for implantation in a body lumen is disclosed. The present invention provides a lumen support stent with an unobstructed through-lumen for use in a blood vessel. A constraining mechanism is provided for securely maintaining the stent in the collapsed condition during delivery. The stent is preferably formed with a series of interconnected slide and lock mechanisms for permitting movement from a collapsed condition to an expanded condition and inhibiting radial recoil from the expanded condition. The stent may be formed from a shape memory alloy for providing crush-recovery after deployment.
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Citations
67 Claims
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1. A balloon expandable crush-recoverable stent, comprising:
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at least two radial elements arranged to form a tubular member, the radial elements being slidably interconnected for allowing the tubular member to expand from a collapsed diameter to an expanded diameter, at least one radial element comprising; a locking mechanism for maintaining the tubular member in the expanded diameter after deployment, the locking mechanism comprising a plurality of teeth disposed on a first deflectable member that extends from a first end of the at least one radial element to a second end thereof, the locking mechanism further comprising a locking tab disposed at the first end of the at least one radial element; and a constraining mechanism integrated into the at least one radial element for maintaining the tubular member in the collapsed diameter until released by radial expansion, the constraining mechanism comprising at least one recess disposed on a first containment member that extends from the first end of the at least one radial element to the second end thereof, the constraining mechanism further comprising a hold-down tab disposed at the second end of the at least one radial element; wherein the radial elements are fabricated from a shape-memory material for providing crush-recoverability. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. A balloon expandable stent, comprising:
a substantially flat sheet fabricated from a shape-memory material, the flat sheet comprising at least one radial element being configured to be rolled into a cylindrical configuration for providing a tubular member, the tubular member being configured for expansion from a collapsed diameter to an expanded diameter, the at least one radial element comprising; a locking mechanism provided along the at least one radial element for maintaining the tubular member in the expanded diameter, the locking mechanism comprising first and second deflectable members extending from a first end of the at least one radial element to a second end thereof, the locking mechanism further comprising a locking tab disposed at the first end of the at least one radial element, the first and second deflectable members forming a gap therebetween, the gap being configured to receive the locking tab therein; and a constraining mechanism integrated into the at least one radial element for maintaining the tubular member in the collapsed diameter until released by radial expansion, the constraining mechanism comprising first and second containment members extending from the first end of the at least one radial element to the second end thereof, the first containment member being disposed adjacent to the first deflectable member of the locking mechanism to form a first gap therebetween, the second containment member being disposed adjacent to the second deflectable member of the locking mechanism to form a second gap therebetween, the constraining mechanism further comprising a hold-down tab disposed at the second end of the at least one radial element, the hold-down tab being positionable over first and second deflectable members and positionable through first and second gaps to maintain the at least one radial element in a slidable relationship. - View Dependent Claims (14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29)
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30. A balloon expandable crush-recoverable stent, comprising:
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a tubular member comprising a series of pivotally connected links fabricated from a shape-memory material, each link comprising a first end and a second end, each link comprising one or more ridges along the surface thereof, the ridges of a given link being configured to contact ridges of an adjacent pivotally connected link to limit the pivoting of the given link and the adjacent link relative to each other in a collapsed direction, the pivotally connected links being configured for allowing the tubular member to be adjusted from a collapsed diameter to an expanded diameter, at least one link comprising; a locking mechanism formed between the first and second ends of the at least one link, the locking mechanism configured for maintaining the tubular member in the expanded diameter; and a constraining mechanism integrated into the tubular member and formed between the first and second ends of the at least one link, the constraining mechanism configured for maintaining the tubular member in the collapsed diameter until released by radial expansion of the balloon; and a flexible mechanism for connecting multiple links together to form a stent having a desired axial length. - View Dependent Claims (31, 32, 33)
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34. An expandable stent, comprising:
a tubular member comprising a series of slidably interconnected elements fabricated from a biocompatible material, the tubular member being configured for expansion from a collapsed diameter to an expanded diameter, at least one element comprising; a locking mechanism for maintaining the tubular member in the expanded diameter, the locking mechanism comprising a plurality of teeth disposed on a deflectable member that extends from a first end of the at least one element to a second end thereof, the locking mechanism further comprising a locking tab disposed at the first end of the at least one element; and a constraining mechanism for maintaining the tubular member in the collapsed diameter until released by radial expansion, the constraining mechanism comprising at least one lock formed along a containment member that extends from the first end of the at least one element to the second end thereof, the constraining mechanism further comprising at least one arm disposed at the second end of the at least one element, the arm extending from the at least one element such that the arm of the at least one element contacts a lock of an element to provide initial resistance to radial expansion, the arm being deflectable relative to the lock to disengage with the lock upon forcible radial expansion. - View Dependent Claims (35, 36, 37)
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38. An expandable stent, comprising:
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first and second expandable modules, each expandable module comprising at least one radial element, each expandable module forming a substantially tubular member and being adjustable from a collapsed condition to an expanded condition, at least one radial element comprising; a locking mechanism for maintaining the tubular member in the expanded diameter after deployment, the locking mechanism comprising a plurality of teeth disposed on a first deflectable member that extends from a first end of the at least one radial element to a second end thereof, the locking mechanism further comprising a locking tab disposed at the first end of the at least one radial element; and a constraining mechanism for maintaining the stent in the collapsed condition during delivery to a treatment site, the constraining mechanism comprising at least one recess disposed on a first containment member that extends from the first end of the at least one radial element to the second end thereof, the constraining mechanism further comprising a hold-down tab disposed at the second end of the at least one radial element; and a flexible coupling portion for coupling the first and second expandable modules together; wherein each of the expandable modules is substantially independently expandable. - View Dependent Claims (39, 40, 41, 42, 43, 44, 45, 46, 47)
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48. An expandable stent for supporting a blood vessel, comprising:
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a tubular member fabricated from a biocompatible material, the tubular member comprising at least one radial element and having a first end portion and a second end portion, the tubular member being configured for expansion from a collapsed diameter to an expanded diameter, the tubular member having a central region disposed between the first end portion and the second end portion, the at least one radial element comprising; a locking mechanism for maintaining the tubular member in the expanded diameter after deployment, the locking mechanism comprising a plurality of teeth disposed on a first deflectable member that extends from a first end of the at least one radial element to a second end thereof, the locking mechanism further comprising a locking tab disposed at the first end of the at least one radial element; and a constraining mechanism for maintaining the tubular member in the collapsed diameter until released by radial expansion, the constraining mechanism comprising at least one recess disposed on a first containment member that extends from the first end of the at least one radial element to the second end thereof, the constraining mechanism further comprising a hold-down tab disposed at the second end of the at least one radial element; and wherein at least a portion of the central region of the tubular member is formed with a substantially impermeable wall. - View Dependent Claims (49, 50)
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51. A balloon expandable crush-recoverable stent, comprising:
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a first row of radial elements extending along the longitudinal axis of the stent; a second row of radial elements extending along the longitudinal axis of the stent; wherein a radial element of the first row and a corresponding radial element of second row each comprises; a locking mechanism comprising a plurality of teeth disposed on a first deflectable member that extends from a first end of the radial element to a second end thereof, the locking mechanism further comprising a locking tab disposed at the first end of the radial element; and a constraining mechanism comprising at least one loop formed along a first containment member that extends from the first end of the radial element to a second end thereof, the constraining mechanism further comprising at least one hook disposed at the second end of the radial element; wherein the locking tab of the radial element of the second row is operative to engage the teeth of the radial element of the first row; and wherein the radial elements in the first row slidably interconnect with the radial elements in the second row for providing a series of expandable modules, the constraining mechanism maintaining at least one expandable module in a collapsed diameter until released by radial expansion of an inflatable balloon, wherein each of the modules is expandable to a different diameter. - View Dependent Claims (52, 53, 54, 55, 56)
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57. A balloon expandable crush-recoverable stent, comprising:
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a first row of radial elements extending along the longitudinal axis of the stent; a second row of radial elements extending along the longitudinal axis of the stent; wherein at least one radial element comprises; a locking mechanism comprising a plurality of teeth disposed on a first deflectable member that extends from a first end of the at least one radial element a second end thereof, the locking mechanism further comprising a locking tab disposed at the first end of the at least one radial element, the locking tab of the at least one radial element being operative to engage the teeth of another radial element; and a constraining element comprising a gap formed by at least one deflectable member at a second end of the at least one radial element, the constraining mechanism further comprising a flexible wing disposed at the second end of the at least one radial element, the flexible wing defining a passing profile that is larger than the gap, the wing being configured such that the wing can be disposed through a gap of another radial element with the stent being in an unexpanded state and provide initial resistance to radial expansion of the stent until deflecting and exiting the gap; wherein the first and second rows of radial elements form at least a portion of a tubular member, the first and second rows of radial elements being slidably interconnected along a plurality of points for allowing the tubular member to expand from a collapsed condition to an expanded condition, the constraining mechanism maintaining the tubular member in the collapsed condition until released by radial expansion of an inflatable balloon. - View Dependent Claims (58, 59)
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60. A balloon expandable crush-recoverable stent, comprising:
first and second expandable modules, each module comprising a series of slidably interconnected elements fabricated from a shape-memory material, each element comprising a pair of containment members extending generally parallel to at least one deflectable member that is spaced between the containment members, the containment members and the deflectable member extending from a first end of the element to a second end thereof, the containment members being spaced from the at least one deflectable member to define first and second gaps therebetween, the interconnected elements being configured for allowing the module to be adjusted from a collapsed diameter to an expanded diameter, each element further comprising; a locking mechanism being configured such that the interconnected elements are slidable in only one direction for maintaining the expandable module in the expanded diameter; and a constraining mechanism comprising a hold-down tab extending from the second end of each radial element, a hold-down tab of a first radial element being disposed over at least one deflectable member and disposed through first and second gaps of a second radial element to maintain the first and second radial elements in a slidable relationship, the constraining mechanism being configured to maintain the expandable module in the collapsed diameter until released by radial expansion of an inflatable balloon during deployment at a treatment site. - View Dependent Claims (61, 62)
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63. A balloon expandable stent, comprising:
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at least two substantially flat elements configured to be rolled into a cylindrical configuration to provide a tubular member, each of the flat elements forming a portion of a circumference of the tubular member, the elements being slidably interconnected for allowing the tubular member to expand from a collapsed diameter to an expanded diameter without any substantial plastic deformation of the elements, at least one element comprising; a locking mechanism comprising a plurality of teeth disposed on a first deflectable member that extends from a first end of the at least one element to a second end thereof, the locking mechanism further comprising a locking tab disposed at the first end of the at least one element; and a constraining mechanism for maintaining the tubular member in the collapsed diameter until released by radial expansion, the constraining mechanism comprising at least one loop formed along a first containment member that extends from the first end of the at least one element to the second end thereof, the constraining mechanism further comprising at least one hook disposed at the second end of the at least one element; and an expandable sheath disposed over the tubular member, the expandable sheath being configured to expand during deployment of the stent at the treatment site. - View Dependent Claims (64, 65, 66, 67)
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Specification