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Publication Number
US-10617859-B2
Publication Date
2020-04-14
Expiration Date
Abstract
A valve (100) for use in delivering a medical device comprises first and second ends and an hourglass shaped centre section defining an aperture (34) for accepting a guidewire. The application of torsion about the centre section closes the aperture to seal against the guidewire.
Core Innovation
The disclosure describes a valve for use in delivering a medical device in which a body defines a passage between a first end and a second end along a longitudinal axis, and a wall defining the passage includes a flexible member defining an aperture. The aperture has a first diameter when in an unstressed state that is less than the internal diameter of the passage at one or both of the first and second ends. When an element having an external diameter greater than the first diameter is inserted into the aperture, the diameter of the aperture increases to accommodate the element and to create a seal around the element.
The valve is fixed in a twisted state, with the flexible member under a fixed degree of torsion and the first end of the body nonrotatably secured relative to the second end, while the wall defining the passage is in longitudinal tension between the first and second ends. In this fixed twisted state and without any element in the aperture, the diameter of the aperture is reduced and is maintained reduced prior to subsequent insertion.
In further embodiments, the disclosure specifies longitudinal tension geometry and dimensional relationships to reduce creep and improve sealing performance over time, including a body length along the longitudinal axis between 120% and 150% of the body’s unstretched length. Additional optional features include resistance means that resist an increase of the diameter of the aperture, and an optional tubular liner such as an ePTFE tubular liner to reduce insertion force and prevent adhesion (“sticktion”). Alternative embodiments include a multi-aperture sequential design for higher pressure sealing.
Claims Coverage
The document includes two independent claims, each directed to a valve for delivering a medical device and both requiring a fixed twisted state together with longitudinal tension to maintain a reduced aperture diameter prior to insertion and to enable sealing around an inserted element.
Valve with reduced unstressed aperture diameter that seals upon insertion
A valve for use in delivering a medical device, including a body having a first end and a second end disposed along a longitudinal axis, and a wall defining a passage between the first and second ends; a flexible member disposed about the passage, the flexible member being spaced from each of the first and second ends and defining an aperture along the passage, the aperture having a first diameter when in an unstressed state, wherein the first diameter is less than the internal diameter of the passage at one or both of the first and second ends, and when an element having an external diameter greater than the first diameter is inserted into the aperture, the diameter of the aperture increases to accommodate the element and to create a seal around the element.
Fixed twisted state with longitudinal tension to reduce aperture diameter prior to insertion
The valve fixed in a twisted state, with the flexible member under a fixed degree of torsion, with the first end of the body being nonrotatably secured relative to the second end, with the wall defining the passage being in longitudinal tension between the first and second ends of the body, and without any element being within the aperture of the flexible member.
Converging passage defining a narrowed aperture that seals when element diameter exceeds aperture diameter
A valve for use in delivering a medical device, including a body having a wall defining a passage extending between a first end and a second end, the passage converging inwardly from the first end and from the second end to define a narrowed aperture between the first and second ends, wherein the wall is flexible about the aperture, whereby the aperture seals about an element of a medical device inserted therein if the element has a diameter greater than the diameter of the aperture.
Fixed twisted and longitudinally tensioned valve that reduces aperture diameter prior to subsequent insertion
The valve fixed in a twisted state, with one of the first and second ends of the body being twisted and nonrotatably fixed with respect to the other such that the body is in a fixed degree of torsion and the wall defining the passage is in longitudinal tension between the first and second ends of the body, without any element being in the aperture, whereby the diameter of the aperture is reduced prior to subsequent insertion of any element therein.
Both independent claims define a valve that includes a reduced-diameter aperture formed by a flexible wall/member that seals when an inserted element is larger than the aperture diameter. The central claim coverage feature is maintaining a reduced aperture diameter before insertion by fixing the valve in a twisted (torsioned) state while applying longitudinal tension between the body ends, with nonrotatable fixation of the ends relative to each other.
Stated Advantages
Sealing around the inserted element.
Reduced aperture diameter maintained prior to subsequent insertion of any element.
Improved sealing performance associated with reducing creep, as described in the disclosure’s performance discussion.
Optional resistance means to resist increase of the diameter of the aperture.
Optional tubular liner to reduce insertion force and prevent adhesion (“sticktion”).
Documented Applications
Endovascular medical implant delivery, including delivery of a stent graft (described as an example endovascular medical implant delivery system).
Valved vascular access sheath and delivery catheter sheath (described in the disclosure context as examples).
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