Stent loading device with fluid reservoir

Inventors

Peterson, Alex A. • Diedering, Jason S. • Kumar, Saravana B.

Assignees

4C Medical Technologies Inc

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 alternating between two sections of decreasing diameter and two sections of constant diameter until reaching the inner diameter of the delivery sheath. A fluid-filled reservoir is provided at the proximal end of the loading device that is configured to provide moisture or wetting for materials associated with or attached to the stent that require moisture retention. Thus, as the stent is being collapsed with the loading device, at least a portion of the stent may be immersed in the fluid reservoir to preserve the subject material.

Core Innovation

The invention relates to a loading device for collapsing a stent comprising material requiring moisture retention in preparation for delivery and implantation into a body. The loading device includes a fluid reservoir with a curved inner surface operatively connected with a proximal end of the loading device and in fluid communication with an inner lumen of the loading device. The fluid reservoir includes an open upper surface configured to allow placement of the stent into contact with a fluid so that at least a portion of the stent is immersed in the fluid to support moisture retention of the material.

The loading device further defines the inner lumen geometry to initiate controlled, predictable collapsing of the stent. The inner lumen of the loading device comprises two sections of decreasing inner diameter in a proximal-to-distal direction and two sections of constant inner diameter. This staged diameter profile is configured so that the collapsed stent achieves a predetermined shape and diameter for translation, delivery and implantation.

In the method aspects, a collapsible and expandable stent is translated across the open upper surface and into the inner lumen to initiate controlled, predictable collapsing while ensuring that at least a portion of the stent is immersed within the fluid of the fluid reservoir. Pressure is applied to further translate the stent through the inner lumen so that the collapsed stent achieves the predetermined shape and diameter for translation, delivery and implantation. The method further includes translating the collapsed stent into a lumen of an operatively connected delivery sheath for translation, delivery and implantation.

A related method aspect covers pre-loading a stent to a collapsed configuration in preparation for subsequent translation and implantation within an anatomical target. The method provides a collapsible and expandable stent comprising a material requiring moisture retention, and a loading device with a fluid reservoir having a curved inner surface and an open upper surface and an inner lumen with two decreasing inner-diameter sections and two constant inner-diameter sections. The stent is translated across the open upper surface and partially into the inner lumen to initiate controlled, predictable partial collapsing while ensuring immersion in the fluid to wet the material requiring moisture retention, followed by further translation to achieve a predetermined collapsed shape and diameter for translation through an operatively connected delivery sheath.

Claims Coverage

The patent document provides three independent claims (a loading device claim and two method claims). Across these independent claims, the coverage centers on a fluid-reservoir loading device with a curved inner surface and open upper surface plus an inner lumen with a proximal-to-distal diameter profile that enables controlled, predictable collapsing to a predetermined collapsed shape and diameter, while maintaining moisture retention by immersion in reservoir fluid.

Claim coverage is anchored in the combination of a moisture-retaining fluid reservoir defined by a curved inner surface and open upper surface for stent contact, and an inner lumen having two decreasing-diameter sections and two constant-diameter sections to support controlled, predictable collapsing to a predetermined collapsed shape and diameter. The method claims add translation across the reservoir open upper surface, immersion during controlled collapsing, and subsequent pressure-based translation into an operatively connected delivery sheath, including a pre-loading variant with partial collapsing and moisture wetting.

Stated Advantages

Documented Applications