Methods and devices for deploying and releasing a temporary implant within the body
Methods, devices and systems for delivering a device assembly into a gastric or other space within the body, allowing the device to expand to occupy volume within the gastric space and, after an effective period of time, delivering a substance or stimulus to begin breakdown of the expanded device so that it may release from the body.
1. A medical device for occupying a space within a patient's body, the medical device comprising:
a device assembly comprising a barrier layer, the barrier layer defining a reservoir therein, where the device assembly is configured to expand from a deployment profile into an active profile upon delivery of a fluid into the reservoir, where the deployment profile permits positioning of the device assembly within the patient's body;
an elongate tubular structure extending into the reservoir, where the elongate tubular structure is configured to collapse to prevent movement of fluid therethrough;
an elongate conduit having a proximal end and a device end, where, the elongate conduit is positioned through the elongate tubular structure to deliver the fluid into the reservoir, where the device end of the elongate conduit is removably located within the elongate tubular structure, such that removal of the elongate conduit from the elongate tubular structure allows the elongate tubular structure to collapse and bend into an arcuate shape; and
wherein in the deployment profile the device assembly is configured to fit within an oral dosage form selected from a group consisting of a pill, capsule, and sleeve allowing for swallowing of the device assembly without the aid of another medical device.
2. The device of claim 1 , where the elongate conduit comprises a slidable fit with the elongate tubular structure.
3. The device of claim 1 , where elongate tubular structure is located within the reservoir and does not extend beyond the barrier layer.
4. The device of claim 1 , where the elongate tubular structure extends from within the reservoir to beyond the barrier layer.
5. The device of claim 1 , where the elongate conduit extends beyond the elongate tubular structure within the reservoir.
6. The device of claim 1 , where the elongate tubular structure is configured to seal upon hydrostatic pressure within the reservoir.
7. The device of claim 1 , where the barrier layer comprises at least one opening and where each of the at least one opening is covered by a release material.
8. The device of claim 7 , where the release material comprises a plurality of discrete portions covering a plurality of openings in the barrier layer.
9. The device of claim 1 , where the barrier layer comprises at least two edges that are mechanically bound together by a portion of a release material to close the barrier layer.
10. The device of claim 9 , where the at least two edges of the barrier layer are located on an interior of the device assembly.
11. The device of claim 1 , where a release material is located on an interior of the barrier layer such that the release material is physically separated from bodily fluids.
12. The device of claim 1 , further comprising a release channel located on the interior of the barrier layer, where a wall of the release channel separates a release material from the release channel such that the release material remains physically separated from an environment within the patient's body until reduction of the structural integrity of the release material prevents the release material from closing the release channel.
13. The device of claim 1 , wherein the barrier layer is fluid impermeable.
14. The device of claim 1 , where a volume of the device assembly is expandable to at least 300 ml in the active profile.
15. A medical device for occupying a space within a patient's body, the medical device comprising:
a device assembly comprising a barrier layer, the barrier layer defining a reservoir therein, where the device assembly is configured to expand from a deployment profile into an active profile upon delivery of a fluid into the reservoir, where the deployment profile permits positioning of the device assembly within the patient's body;
an elongate tubular structure extending into the reservoir and comprising at least a first layer and a second layer, where the first layer and the second layer are sealed together along at least two lateral edges of the elongate tubular member, and where the elongate tubular structure is configured to collapse to seal the elongate tubular structure upon an increase in a hydrostatic pressure in the reservoir by delivery of the fluid; and
an elongate conduit having a proximal end and a device end, where the device end is flexible to accommodate swallowing by the patient, the elongate conduit is positioned through the elongate tubular structure to deliver the fluid into the reservoir, where the device end of the elongate conduit is removably located within the elongate tubular structure, such that removal of the elongate conduit from the elongate tubular structure allows the elongate tubular structure to collapse and bend into an arcuate shape.
16. The device of claim 15 , where the elongate conduit comprises a slidable fit with the elongate tubular structure.
17. The device of claim 15 , where the elongate tubular structure is located within the reservoir and does not extend beyond the barrier layer.
18. The device of claim 15 , where the elongate tubular structure extends from within the reservoir to beyond the barrier layer.
19. The device of claim 15 , where a release material is located on an interior of the barrier layer such that the release material is physically separated from bodily fluids.