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 body having an interior reservoir;
a fluid filler material configured to expand within the interior reservoir;
a fill valve configured to deliver the fluid filler material into the interior reservoir, wherein expansion of the fluid filler material increases pressure against the fill valve, wherein the fill valve comprises a first layer and a second layer and a flow control material between the first layer and the second layer, wherein the fill valve comprises a first fluid path between the first layer and the second layer, wherein the fluid filler material closes the first fluid path by pressing the first layer and the second layer toward the flow control material such that the first fluid path is closed;
a release channel providing a second fluid path between an exterior of the device body and the interior reservoir;
a restraining element that closes the release channel 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, wherein the restraining element is monolithic; and
wherein the fluid filler material degrades the restraining element to unseal the release channel.
2. 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.
3. The medical device of claim 1 , further comprising an energy storage element coupled to the release channel, wherein the energy storage element is an elastically resilient member, wherein the elastically resilient member is configured to expand the release channel upon degradation of the restraining element.
4. The medical device of claim 1 , wherein the first layer is positioned outside of a surface of the device and comprises a preformed first opening, wherein the second layer is positioned inside of the surface of the device and comprises a preformed second opening, wherein the flow control material is impermeable to fluid, and wherein the fill valve has a first configuration wherein the first 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 first fluid path is blocked by the flow control material.
5. The medical device of claim 4 , 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.
6. The medical device of claim 5 , 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 first 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 first fluid path.
7. The medical device of claim 4 , wherein the first layer and the second layer are partially permeable.
8. The medical device of claim 7 , wherein the first layer and the second layer are permeable to fluid material and impermeable to non-fluid material.
9. The medical device of claim 1 , further comprising an exogenous stimuli configured to cause degradation of the restraining element when the exogenous stimuli acts on the restraining element.
10. A medical device for occupying a space within a patient's body, the medical device comprising:
a device body having an interior reservoir;
a fluid filler material configured to expand within the interior reservoir;
a fill valve configured to deliver the fluid filler material into the interior reservoir, wherein expansion of the fluid filler material increases pressure against the fill valve, wherein the fill valve comprises a first layer and a second layer and a flow control material between the first layer and the second layer, wherein the fill valve comprises a first fluid path between the first layer and the second layer, wherein the fluid filler material closes the first fluid path by pressing the first layer and the second layer toward the flow control material such that the first fluid path is closed;
a release channel configured to control flow through a second-first fluid path, where the second 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 second fluid path and an open configuration permitting flow of the fluid filler material through the second fluid path; and
a restraining element that closes the release channel in the sealed configuration 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, wherein the restraining element is monolithic; and
wherein the fluid filler material degrades the restraining element to unseal the release channel and to assist in opening the release channel.
11. The medical device of claim 10 , wherein the restraining element is physically separated from fluids within the patient's body, wherein the restraining element is within the interior reservoir.
12. The medical device of claim 10 , further comprising an energy storage element coupled to the release channel, 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.
13. The medical device of claim 10 , the first layer is positioned outside of a surface of the device and comprises a preformed first opening, wherein the second layer is positioned inside of the surface of the device and comprises a preformed second opening, wherein the flow control material is impermeable to fluid, and wherein the fill valve has a first configuration wherein the first 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 first fluid path is blocked by the flow control material.
14. The medical device of claim 13 , 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.
15. The medical device of claim 14 , 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 first 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 first fluid path.
16. The medical device of claim 13 , wherein the first layer and the second layer are partially permeable.
17. The medical device of claim 16 , wherein the first layer and the second layer are permeable to fluid material and impermeable to non-fluid material.
18. The medical device of claim 10 , further comprising an exogenous stimuli configured to cause degradation of the restraining element when the exogenous stimuli acts on the restraining element.