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Publication Number
US-11857441-B2
Publication Date
2024-01-02
Expiration Date
Abstract
A device and method for predictably and controlling the collapsing of a collapsible and expandable stent for subsequent translation through a delivery sheath lumen to an anatomical target such as a heart valve or intravascular location for expansion and implantation. The loading device defines in inner lumen comprising a successively decreasing, from the proximal to the distal direction, inner diameter to a region of constant inner diameter wherein the stent is in a collapsed configuration. The device and method may provide for an at least partially collapsed configuration of the stent that may be further collapsed as a part of the implantation procedure and may comprise a stent that is pre-loaded for future use.
Core Innovation
The invention relates to a loading device for collapsing a collapsible stent in preparation for delivery and implantation into a body. The loading device includes a proximal decreasing diameter section having a conical outer diameter and a lumen with a conical inner diameter smaller than the conical outer diameter, smoothly transitioning from a maximum diameter at a proximal end to a minimum diameter at a distal end. This proximal decreasing diameter geometry is used to collapse the collapsible stent.
A constant diameter section is connected to, or integrated with, the proximal decreasing diameter section at the distal end and defines a lumen with an inner diameter that is substantially constant and substantially equal to the minimum diameter of the proximal decreasing diameter section. The lumen of the constant diameter section extends from the distal end of the proximal decreasing diameter section to a distal end of the constant diameter section, and the sheath extends within and through the lumen defined by the constant diameter section. Liquid is disposed within the lumen of the proximal decreasing diameter section and/or the lumen of the constant diameter section and/or the lumen of the sheath.
The invention also includes a sheath operatively connected to and extending within the lumen of the constant diameter section, where the sheath comprises a planar sheet adaptable to define a tubular form with an outer diameter enabling translation and/or rotation within the lumen of the constant diameter section. The tubular form includes a longitudinal slot extending along an entire length of the sheath, and the constant diameter section comprises a male member adapted to engage with, and slide within, the longitudinal slot when the sheath is translated within the lumen of the constant diameter section.
Claims Coverage
The partial content provides two independent claims. Across these claims, there are three main inventive features: the loading device geometry with proximal decreasing and constant diameter sections, the sheath formed from a planar sheet with a longitudinal slot cooperating with a male member, and the use of liquid disposed within one or more of the lumen(s) for wetting/moisture retention while collapsing and delivering the stent into the sheath lumen.
Proximal decreasing and constant diameter lumen geometry for stent collapse
A proximal decreasing diameter section defining a lumen with an inner diameter smoothly transitioning from a maximum at a proximal end to a minimum at a distal end, and a constant diameter section connected to or integrated with the distal end and defining a lumen with an inner diameter substantially constant and substantially equal to the minimum diameter.
Sheath tubular form from planar sheet with longitudinal slot cooperating with a male member
A sheath operatively connected to and extending within the lumen of the constant diameter section, wherein the sheath comprises a planar sheet adaptable to define a tubular form enabling translation and/or rotation within the lumen of the constant diameter section, the tubular form having a longitudinal slot along an entire length of the sheath when in the tubular form, and wherein the constant diameter section includes a male member adapted to engage with, and slide within, the longitudinal slot when the sheath is translated within the lumen of the constant diameter section.
Liquid disposed within lumen(s) to wet the stent and/or loading device
Liquid disposed within the lumen of the proximal decreasing diameter section, the lumen of the constant diameter section and/or the lumen of the sheath, where the loading device is configured to collapse the collapsible stent and deliver the collapsed stent into the lumen of the sheath.
Stent pre-loading by distal translation and pressure into proximal decreasing and constant diameter sections
A method providing a collapsible stent and a loading device with a proximal decreasing diameter section and a constant diameter section connected to or integrated with the distal end, translating the stent distally within the proximal decreasing diameter section to begin collapsing, and applying pressure on the stent to translate the stent distally through the lumen of the decreasing diameter section and partially into the lumen of the constant diameter section to partially collapse the stent therein, with the sheath comprising a planar sheet adaptable to define a tubular form with a longitudinal slot.
The independent claim set centers on collapsing a collapsible stent using a proximal decreasing diameter section transitioning to a constant diameter section, while coordinating a planar-sheet-derived tubular sheath having a longitudinal slot with a male member sliding engagement, and disposing liquid within one or more lumen(s). A related independent method claim defines stent pre-loading by distally translating the stent and applying pressure so the stent partially collapses within the constant diameter section and is associated with the slot-based sheath structure.
Stated Advantages
Provides fluid/moisture retention by disposing fluid within the funnel and/or sheath so biologic materials remain wetted.
Documented Applications
Loading and delivery of a collapsed collapsible stent for delivery and implantation into a body, including delivery into the lumen of the sheath.
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