INSERTION DEVICES AND METHODS OF USE THEREOF
Aspects of the present disclosure are directed to devices for inserting expandable balloons into an implantation site of a patient. Such devices may include a base ( 326 ) having a longitudinal axis and defining a cavity ( 322 ); an expandable balloon ( 330 ) disposed within the cavity in a collapsed configuration; and a flexible lumen ( 310 ) extending proximally from the balloon to a pump ( 302 ), the flexible lumen fluidly connecting the balloon to the pump. The base may include a projection extending distally, parallel to the longitudinal axis, wherein at least a portion of the balloon is coupled to the projection. Further, for example, the device may include a cover ( 324 ) coupled to the base and movable relative to the base to selectively cover and expose the cavity to deploy the balloon.
1 . An insertion device, comprising:
a base having a longitudinal axis and defining a cavity;
an expandable balloon disposed within the cavity in a collapsed configuration; and
a flexible lumen extending proximally from the balloon to a pump, the flexible lumen fluidly connecting the balloon to the pump.
2 . The device of claim 1 , wherein the base includes a projection extending distally, parallel to the longitudinal axis, wherein at least a portion of the balloon is coupled to the projection.
3 . The device of claim 2 , wherein the balloon is affixed to the projection with an adhesive.
4 . The device of claim 2 or 3 , wherein a longitudinal length of the projection is at least half a longitudinal length of a tube that defines the cavity.
5 . The device of claim 1 , wherein the device includes a cover coupled to the base and movable relative to the base to selectively cover and expose the cavity to deploy the balloon.
6 . The device of claim 5 , wherein the cover is slidable relative to the base along the longitudinal axis, or wherein the cover is coupled to the base with a removable clip.
7 . The device of claim 5 or 6 , wherein the cover is configured to completely enclose the balloon within the cavity.
8 . The device of any of the preceding claims, wherein a distal end of the base includes a tapered atraumatic tip.
9 . The device of any of the preceding claims, wherein a proximal portion of the base includes a handle.
10 . The device of any of the preceding claims, wherein the base includes a plurality of measurement markings.
11 . The device of any of the preceding claims, wherein a diameter of the balloon in the collapsed configuration is between about 10 mm and about 15 mm.
12 . The device of any of the preceding claims, wherein the balloon is in fluid communication with a supply of air.
13 . The device of any of the preceding claims, wherein a cross-sectional dimension of the base is less than about 3 cm, such as from about 0.5 cm to 3 cm.
14 . A kit, comprising:
the device of any of the preceding claims; and
a cup defining an interior volume, the cup configured to be placed external to a target site and to limit expansion of the balloon inside the target site.
15 . The kit of claim 14 , wherein the cup includes a side opening.
16 . An insertion device, comprising:
a base including a proximal end portion, a distal end portion, and a cavity, the cavity including an opening;
a balloon disposed within the cavity in a collapsed configuration;
a cover movably coupled to the base, wherein the cover, when in a closed configuration with the base, restricts movement of the balloon; and
a flexible lumen extending from the balloon through the proximal end portion of the base to a pump, the flexible lumen fluidly connecting the balloon to the pump.
17 . The device of claim 16 , wherein the distal end portion of the base is tapered.
18 . The device of claim 16 , wherein the cover partially obstructs the opening of the cavity in the closed configuration with the base.
19 . The device of claim 16 , wherein the cavity is disposed at or proximate the distal end portion of the base, and wherein the device further comprises a handle at the proximal end portion of the base.
20 . The device of claim 16 , wherein the cover is slidable relative to the base in a direction parallel to a proximal-distal axis of the base.
21 . The device of claim 16 , wherein the cover is frangibly connected to the base.
22 . The device of claim 16 , wherein the cover includes parallel extensions configured to restrict movement of the balloon.
23 . The device of claim 16 , wherein the base and cover define a length extending along a proximal-distal axis, and a width perpendicular to the length, wherein the length is greater than the width.
24 . The device of claim 16 , wherein the base and the cover include complementary features that restrict rotational movement of the base and the cover relative to each other.
25 . The device of claim 24 , wherein complementary features of the base and the cover permit the base and the cover to slide relative to each other along a proximal-distal axis.
26 . The device of claim 16 , wherein the base and the cover are coupled to one another by a clip extending at least partly around a circumference of the device.