Stent loading device
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.
1. A loading device for collapsing a collapsible stent in preparation for delivery and implantation into a body, the loading device comprising:
a proximal decreasing diameter section comprising a conical outer diameter and further defining a lumen with a conical inner diameter smaller than the conical outer diameter and smoothly transitioning and ranging from a maximum diameter at a proximal end to a minimum diameter at a distal end of the proximal decreasing diameter section;
a constant diameter section connected to, or integrated with, the proximal decreasing diameter section at the distal end of the proximal decreasing diameter section and comprising an outer diameter and further defining a lumen with an inner diameter that is substantially constant and substantially equal to the minimum diameter of the proximal decreasing diameter section, wherein 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;
a sheath comprising a lumen extending lengthwise therethrough and operatively connected to, and extending within, the lumen of the constant diameter section, the sheath comprising an outer diameter that is the same as, or smaller than, the minimum diameter of the proximal decreasing diameter section, wherein the sheath extends all the way through the lumen defined by the constant diameter section; and
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;
wherein the loading device is configured to collapse the collapsible stent and to deliver the collapsed stent into the lumen of the sheath;
wherein the sheath comprises:
a planar sheet that is adaptable to define a tubular form with an outer diameter that enables translation and/or rotation within the lumen of the constant diameter section; and
a longitudinal slot extending along an entire length of the sheath when in the tubular form; and
wherein 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.
2. The loading device of claim 1 , wherein relative rotation between the sheath and the constant diameter section is prevented by the engagement of the male member with the longitudinal slot.
3. The loading device of claim 1 , wherein the sheath further comprises a radial slot in communication with the longitudinal slot, wherein the male member is further adapted to slide within the radial slot to prevent longitudinal translation between the constant diameter section and the sheath.
4. A method of loading and/or pre-loading a collapsible stent for the collapsing of the stent within a loading device lumen, comprising:
providing the collapsible stent;
providing the loading device comprising:
a proximal decreasing diameter section defining a lumen with an inner diameter smoothly transitioning and ranging from a maximum at a proximal end to a minimum at a distal end of the proximal decreasing diameter section; and
a constant diameter section connected to, or integrated with, the distal end of the proximal decreasing diameter section and defining a lumen with an inner diameter that is substantially equal to the minimum diameter of the proximal decreasing diameter section; and
a sheath comprising a lumen therethrough and operatively connected to, and extending within, the lumen of the constant diameter section, the sheath comprising an outer diameter that is the same as, or smaller than, the minimum inner diameter of the proximal decreasing diameter section;
translating the stent distally within the proximal decreasing diameter section to begin the collapsing of the stent; 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;
wherein the sheath comprises:
a planar sheet that is adaptable to define a tubular form with an outer diameter that enables translation and/or rotation within the lumen of the constant diameter section; and
a longitudinal slot extending along an entire length of the sheath when in the tubular form.
5. The method of claim 4 , further comprising continuing to apply pressure to distally translate the stent all the way into the lumen of the constant diameter section to completely collapse the stent therein.
6. The method of claim 5 , further comprising continuing to apply pressure to distally translate the completely collapsed stent at least partially into the lumen of the sheath.