Methods and devices for deploying and releasing a temporary implant within the body
View Patent ↗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 first fluid impermeable surface material forming 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 fluid tunnel ending within the interior reservoir; and
a release channel formed by an interior of a second fluid impermeable material, where the release channel is in fluid communication with the interior reservoir and is temporarily fluidly sealed by a release material located in the interior reservoir about an exterior of the second fluid impermeable material to mechanically secure the second fluid impermeable material to fluidly seal the release channel and to prevent fluid transfer to or from the patient's body until the fluid filler material reduces the structural integrity of the release material to unseal the release channel.
2. The device of claim 1 , where the fluid impermeable material forming the release channel comprises a portion of the surface material.
3. The device of claim 2 , where the second fluid impermeable material forming the release channel comprises at least two layers of the second fluid impermeable surface sealed along at least one edge.
4. The device of claim 1 , where the second fluid impermeable material forming the release channel comprises a tapered shape.
5. The device of claim 1 , where the second fluid impermeable material forming the release channel and the first fluid impermeable surface material are joined together.
6. The device of claim 1 , where upon the addition of the fluid filler material to the interior reservoir the release material begins to structurally degrade to unseal the release channel.
7. The device of claim 1 , where the release channel includes an axis and where the second fluidly impermeable material is twisted about the axis prior to being temporarily restrained.
8. The device of claim 7 , further comprising an energy storage element located within the release channel, where the energy storage element is restrained by the release material in a compressed configuration.
9. The device of claim 8 , where the energy storage element comprises an elastically resilient member, on release of the temporary restraint, the elastically resilient member expands the release channel.
10. The device of claim 1 , further comprising at least one suture member, where the at least one suture member mechanically couples a fluid conduit to at least one wall of the fluid tunnel.
11. The device of claim 10 , where the suture is coupled to at least one weakened section of the wall of the fluid tunnel such that applying a proximal force on the suture member detaches the weakened section from the wall of the fluid tunnel to decouple the fluid tunnel from the fluid conduit.
12. The device of claim 10 , where the conduit is coupled to at least one weakened section of the wall of the fluid tunnel such that applying a tensile force on the conduit detaches the weakened section from the wall of the fluid tunnel to decouple the conduit from the fluid tunnel.
13. The device of claim 10 , further comprising a swellable material located between the fluid tunnel and the fluid conduit.
14. 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 being expandable to an active profile upon addition of the fluid filler material into the interior reservoir;
a valve extending within the interior reservoir, the valve being pre-disposed to obstruct fluid flow therethrough; and
a fluid passage formed by an interior a section of material, where the fluid passage is in fluid communication with the interior reservoir and where the section of material is temporarily mechanically closed from an exterior of the section of material to fluidly seal the fluid passage to prevent fluid transfer between the interior reservoir and the patient's body until the fluid filler reduces the structural integrity of a segment of a release material to unseal the fluid passage, where the segment of the release material is located in the interior reservoir and does not extend into the fluid passage.
15. The device of claim 14 , where the section of material comprises a tapered shape.
16. The device of claim 14 , where the device body is formed from a fluid impermeable surface material and where the section of material is joined with the fluid impermeable surface material.
17. The device of claim 14 , where the release material comprises a rate of hydrolysis that causes degradation of the release material after a predetermined time of at least two weeks.
18. The device of claim 14 , where on the addition of the fluid filler material to the interior reservoir, the release material structurally degrades sufficiently to release the section of material from restraint.
19. The device of claim 14 , where the fluid passage includes an axis and where the section of material is twisted about the axis prior to being temporarily restrained.
20. The device of claim 14 , where the section of material is folded about the axis prior to being temporarily restrained.
21. The device of claim 14 , further comprising an energy storage element located within the fluid passage, where the energy storage element is restrained by a temporary restraint in a compressed configuration.
22. The device of claim 14 , further comprising at least one suture member, where the at least one suture member mechanically couples a fluid conduit to the valve.
23. The device of claim 22 , where at least a first end of the suture member extends to a proximal end of the fluid conduit.
24. The device of claim 23 , where the first and a second end of the suture member extends to the proximal end of the fluid conduit, and a middle portion of the suture member mechanically couples the fluid conduit to the valve, where pulling on the first or second end of the suture member decouples the fluid conduit from the valve.
25. The device of claim 22 , where the suture is detachably coupled to the valve such that applying a proximal force on the suture member detaches the weakened section from the valve to decouple the valve from the fluid conduit.
26. The device of claim 22 , further comprising a swellable material located between the valve and the fluid conduit.
27. A medical device for use with a fluid filler material 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 upon receiving the fluid filler material expands to an active profile;
a valve within the interior reservoir, the valve being pre-disposed to obstruct flow therethrough;
a release material; and
a fluid passage formed by a section of material, where the section of material extends inward into and is temporarily restrained within the reservoir by a section of the release material that is located within the reservoir and exterior to the fluid passage, wherein when temporarily restrained, fluid is prevented from passing from the reservoir through the fluid passage and into the patient's body, and where degradation of the section of the release material frees the section of material from restraint to permit opening of the fluid passage to allow egression of fluids from the interior reservoir.
28. The device of claim 1 , where a fluid conduit having a distal portion disposed within the fluid tunnel to create a fluid path through the fluid tunnel for delivery of the fluid filler material into the interior reservoir.