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 use with a fluid filler material and for occupying a space within a patient's body, the medical device comprising:
a device body having an interior reservoir, the device body having a deployment profile and expandable to an active profile upon receiving the fluid filler material within the interior reservoir;
a fill valve configured to deliver the fluid filler material into the interior reservoir; and
a release channel providing a first fluid path between an exterior of the device body and the interior reservoir;
an energy storage element coupled to the release channel;
a restraining element that closes the release channel and compresses the energy storage element, such that the restraining element temporarily fluidly constrains the release channel closed to prevent fluid transfer between the exterior of the device body and the interior reservoir until the fluid filler material reduces a structural integrity of the restraining element to unseal the release channel and cause expansion of the energy storage element to assist in opening the release channel, wherein the restraining element is monolithic.
2. The medical device of claim 1 , wherein the fluid filler material is liquid.
3. The medical device of claim 1 , wherein the restraining element is physically separated from fluids within the patient's body, wherein the restraining element is within the interior reservoir.
4. The medical device of claim 1 , wherein the energy storage element is an elastically resilient member, wherein the elastically resilient member is configured to expand the release channel upon breakdown of the restraining element.
5. The medical device of claim 1 , wherein the fill valve comprises a first layer and a second layer, wherein the first layer is positioned outside of a surface of the device and comprises a first opening, wherein the second layer is positioned inside of the surface of the device and comprises a second opening, wherein the fill valve comprises a flow control material between the first layer and the second layer, wherein the flow control material is impermeable to fluid, and wherein the fill valve has a first configuration wherein a second fluid path between the first opening and the second opening is configured for access to an interior of the interior reservoir by a catheter, wherein the fill valve has a second configuration wherein the second fluid path is blocked by the flow control material.
6. The medical device of claim 5 , wherein a first region of the flow control material is attached to the first layer, wherein a second region of the flow control material is attached to the second layer.
7. The medical device of claim 6 , wherein in the first configuration the medical device has no internal pressure such that the first layer and the second layer are separated to form part of the second fluid path, wherein in the second configuration the medical device has an internal pressure such that the first layer and the second layer are juxtaposed to block the second fluid path.
8. The medical device of claim 5 , wherein the first layer and the second layer are partially permeable.
9. The medical device of claim 8 , wherein the first layer and the second layer are permeable to fluid material and impermeable to non-fluid material.
10. The medical device of claim 1 , wherein the fluid filler material is configured to expand within the interior reservoir and increase pressure against the fill valve when expanded.
11. A medical device for use with a fluid filler material and for occupying a space within a patient's body, the medical device comprising:
a device body having an interior reservoir, the device body having a deployment profile and expandable to an active profile upon receiving the fluid filler material within the interior reservoir;
a fill valve configured to deliver the fluid filler material into the interior reservoir; and
a release channel configured to control flow through a first fluid path, where the first fluid path extends between an exterior of the device body and the interior reservoir, the release channel having a sealed configuration preventing flow of the fluid filler material through the first fluid path and having an open configuration permitting flow of the fluid filler material through the first fluid path; and
wherein in the sealed configuration, a restraining element compresses an energy storage element such that when compressed the energy storage element applies a tensile force on the restraining element, such upon degradation of the restraining element by the fluid filler material, the energy storage element expands to assist the release channel in assuming the open configuration.
12. The medical device of claim 11 , wherein the fluid filler material is liquid.
13. The medical device of claim 11 , wherein the restraining element is physically separated from fluids within the patient's body, wherein the restraining element is within the interior reservoir.
14. The medical device of claim 11 , wherein the energy storage element is an elastically resilient member, wherein the elastically resilient member is configured to expand the release channel upon breakdown of the restraining element.
15. The medical device of claim 11 , wherein the fill valve comprises a first layer and a second layer, wherein the first layer is positioned outside of a surface of the device and comprises a first opening, wherein the second layer is positioned inside of the surface of the device and comprises a second opening, wherein the fill valve comprises a flow control material between the first layer and the second layer, wherein the flow control material is impermeable to fluid, and wherein the fill valve has a first configuration wherein a second fluid path between the first opening and the second opening is configured for access to an interior of the interior reservoir by a catheter, wherein the fill valve has a second configuration wherein the second fluid path is blocked by the flow control material.
16. The medical device of claim 15 , wherein a first region of the flow control material is attached to the first layer, wherein a second region of the flow control material is attached to the second layer.
17. The medical device of claim 16 , wherein in the first configuration the medical device has no internal pressure such that the first layer and the second layer are separated to form part of the second fluid path, wherein in the second configuration the medical device has an internal pressure such that the first layer and the second layer are juxtaposed to block the second fluid path.
18. The medical device of claim 15 , wherein the first layer and the second layer are partially permeable.
19. The medical device of claim 18 , wherein the first layer and the second layer are permeable to fluid material and impermeable to non-fluid material.
20. The medical device of claim 11 , wherein the fluid filler material is configured to expand within the interior reservoir and increase pressure against the fill valve when expanded.