Vaginal insert method of manufacture
View Patent ↗A method of manufacture for a vaginal insert. The vaginal insert may have a core, a cover, and a removal element. In various embodiments, the cover can be conformed to the vaginal insert.
1. A method of manufacturing a vaginal insert, the method comprising the steps of:
a. providing a core capable of transitioning between a compressed configuration and a radially expanded configuration, the core comprising:
i. an anchoring element;
ii. a supporting element; and
iii. a node connecting the anchoring element and the supporting element;
b. providing a cover blank, the cover blank, when viewed in a flat configuration prior to a step of inserting the core into the cover blank, comprising:
i. a first layer of material and a second layer of material in a face-to-face relationship with the first layer of material;
ii. a four-sided trapezoidal shape when viewed in a flat configuration prior to the step of inserting the core into the cover blank, wherein two sides of the four-sided trapezoidal shape are provided by a first side seam and a second side seam bonding the first layer of material to the second layer of material, a third side of the four-sided trapezoidal shape is provided by a third side seam bonding the first layer of material to the second layer of material wherein the third side seam extends between and connects the first side seam and the second side seam, and the fourth side of the four-sided trapezoidal shape is provided by an unbonded opening between a pair of overlapping end edges wherein a first end edge of the pair of overlapping end edges is a portion of the first layer of material and a second end edge of the pair of overlapping end edges is a portion of the second layer of material, wherein the fourth side of the four-sided trapezoidal shape is parallel to the third side and extends between and connects the first side seam and the second side seam; and
iii. a first width dimension of the third side of the trapezoidal shape and a second width dimension of the fourth side of the trapezoidal shape which is greater than the first width dimension;
c. inserting the core into the cover blank by placing the third side of the cover blank into contact with a portion of the supporting element of the core and inverting the cover blank over the core resulting in a core and cover blank combination and the third side of the cover blank in proximity to the supporting element of the core and the fourth side of the cover blank in proximity to the anchoring element of the core;
d. attaching a removal element to the cover blank;
e. bonding together the portions of the first layer of material and the second layer of material forming the fourth side of the four-sided trapezoidal shape of the cover blank to form a fourth side seam in the proximity to the anchoring element of the core to fully encase the core within the four side seams thereby converting the cover blank into a cover; and
f. conforming the cover to the core in the area of the node of the core by reducing the dimension of the cover at the node of the core, wherein the step of reducing the dimension of the cover at the node further comprises a step of wrapping a band of material around the cover at the node of the core and maintaining the reduced dimension of the cover by attaching the band of material to the cover.
2. The method of claim 1 wherein the step of attaching the removal element to the cover blank further comprises the step of rotating the core and cover blank combination.