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Publication Number
US-9168060-B2
Publication Date
2015-10-27
Expiration Date
Abstract
An introducer sheath and methods of making the introducer sheath are described. The introducer sheath may include a hub portion and a tubular portion. The hub portion may include a substantially non-planar valve portion in a relaxed state. The valve portion may include an aperture configured to receive a medical device. A hub portion may be formed using a forming device. An aperture may be formed through a distal surface of the valve portion.
Core Innovation
The invention relates to an introducer sheath having an elongate tubular portion that is elastically deformable about a longitudinal axis and a hub portion with a substantially non-planar valve portion in a relaxed state. The valve portion includes an aperture configured to receive a medical device, where the aperture is substantially conical in the relaxed state and substantially cylindrical when the valve is in a substantially planar, deformed state. A sealing surface is provided that is not generally parallel to a longitudinal axis through the aperture in the relaxed state and that forms a seal in the deformed state.
The hub portion and the valve portion are formed as a monolithic, integral, unitary member. In described configurations, the hub portion and valve portion are formed as a monolithic, integral, unitary member together with the tubular portion, so that the tubular portion, hub portion, and valve portion are formed as monolithically, integrally, and unitarily formed of a single material.
The invention further includes manufacturing approaches that form the hub portion and the tubular portion as a unitary or monolithic member and align lumen alignment between the sheath and hub. Described valve forming includes an aperture through a distal surface of the valve portion configured to receive a medical device, where the aperture transitions from a conical aperture in a relaxed state to a substantially cylindrical aperture in a deformed state using forming devices and a blade, including variants that correspond to concave/convex and flared/planar forming geometries.
Claims Coverage
The independent claims cover six core inventive features: an introducer sheath with an elastically deformable tubular portion and a non-planar valve whose aperture changes from conical to cylindrical; monolithic, integral, unitary formation of the valve and hub, and in some claims the tubular portion as well; a concave non-planar valve in a relaxed state; sealing-surface constraints defined by distal and proximal circumferential edges; seal formation between the substantially cylindrical portion of the medical device and the hub in the deformed state; and single-material monolithic formation.
Monolithic integral unitary valve and hub with shape-changing aperture
The hub portion has a substantially non-planar valve portion in a relaxed state, the valve portion has an aperture configured to receive a medical device, the aperture is substantially conical when the valve is in the relaxed state and substantially cylindrical when the valve is in a substantially planar, deformed state, and the hub portion and the valve portion are formed as a monolithic, integral, unitary member.
Elastically deformable tubular portion with non-planar valve aperture transition
The introducer sheath comprises an elongate tubular portion having a longitudinal axis, the elongate tubular portion being elastically deformable about the longitudinal axis, and a hub portion and a valve portion formed as a monolithic, integral, unitary member with said tubular portion, where the valve portion is substantially non-planar in a relaxed state, the valve portion has an aperture configured to receive a medical device, the aperture is substantially conical when the valve is in the relaxed state and substantially cylindrical when the valve is in a substantially planar, deformed state.
Concave non-planar valve in relaxed state
The hub portion has a substantially non-planar valve portion that is substantially concave in a relaxed state.
Sealing surface defined by distal and proximal circumferential edges with orientation constraint
The aperture forms a distal circumferential edge and a proximal circumferential edge defining a sealing surface, the sealing surface being not generally parallel about a longitudinal axis through the aperture in the relaxed state.
Sealing via changing distal/proximal edge diameters from relaxed to deformed state
The distal circumferential edge has a first diameter and the proximal circumferential edge has a second diameter, the sealing surface is configured to form a seal between the substantially cylindrical portion of the medical device and the hub in the deformed state, the first diameter being larger than the second diameter in the relaxed state and the first diameter and the second diameter being substantially the same when in the deformed state.
Single-material monolithic integrally unitary tubular, hub, and valve
The tubular portion, the hub portion, and the valve portion are monolithically, integrally, and unitarily formed of a single material.
Across the independent claims, the introducer sheath is characterized by an elastically deformable tubular portion and a monolithic, integral, unitary hub/valve construction in which a non-planar valve aperture transitions from substantially conical in a relaxed state to substantially cylindrical in a substantially planar, deformed state. For the system claim, the sealing surface is defined by distal and proximal circumferential edges with an orientation constraint in the relaxed state and sealing behavior based on changing distal/proximal diameters from relaxed to deformed state, with the tubular portion, hub portion, and valve portion formed from a single material.
Stated Advantages
Documented Applications
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