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 and for use with a fluid delivery conduit that allows transport of a fluid into the medical device, the medical device comprising:
a device body defining a reservoir;
a tunnel member comprising a first open end located within the reservoir and a second open end, the tunnel member having at least two interior opposing surfaces that define a tunnel lumen extending between the first open end and the second open end;
where the tunnel lumen is sized to slidably receive the fluid delivery conduit such that the fluid delivery conduit is slidably located within the tunnel lumen causing the at least two interior opposing surfaces to hold the fluid delivery conduit in place by friction where the tunnel member assumes an axial profile similar to a portion of the fluid delivery conduit placed therein allowing the fluid delivery conduit to transport the fluid into the reservoir, wherein upon removal of the fluid delivery conduit the at least two interior opposing surfaces of the tunnel member flatten without providing support to the tunnel member such that the tunnel member is unable to maintain a straight profile or the axial profile and bends to a second arcuate profile;
where a portion of the tunnel member is attached to an interior surface within the reservoir of the device body to prevent folding of the tunnel member upon removal of the fluid delivery conduit; and
a substance adjacent to the at least two interior opposing surfaces of the tunnel member, such that upon removal of the fluid delivery conduit, a cohesion of the substance causes the at least two interior opposing surfaces of the tunnel member to stick together increasing a force required to separate the at least two interior opposing surfaces and increasing a resistance to fluid flow through the tunnel lumen.
2. The medical device of claim 1 , wherein the tunnel member comprises a flexible thin wall material such that increasing a pressure within the reservoir increases the resistance to fluid flow through the tunnel lumen.
3. The medical device of claim 1 , wherein the substance comprises a viscous material.
4. The medical device of claim 1 , where the second open end is located exterior to the device body.
5. The medical device of claim 1 , wherein the substance comprises a low-solubility material.
6. The medical device of claim 5 , wherein the substance comprises a bio-compatible lubricant.
7. The medical device of claim 1 , wherein the tunnel member further comprises a first layer and a second layer sealed along at least a first longitudinal edge, the tunnel lumen being adjacent to the at least the first longitudinal edge.
8. The medical device of claim 7 , further comprising a second longitudinal edge adjacent to the tunnel lumen and opposite to the first longitudinal edge, where the first layer and second layer are sealed along the second longitudinal edge.
9. The medical device of claim 1 , further comprising an attachment that couples the fluid delivery conduit to a portion of the tunnel member extending exterior to the device body.
10. The medical device of claim 9 , wherein the attachment comprises a suture.
11. The medical device of claim 9 , wherein the attachment comprises a mechanical or chemical bond.
12. The medical device of claim 1 , wherein a transverse dimension of the tunnel lumen is constant.
13. The medical device of claim 1 , wherein a transverse dimension of the tunnel lumen varies within the tunnel member.
14. The medical device of claim 1 , further comprising at least one pocket in fluid communication with the tunnel lumen where the at least one pocket is configured to retain a substance therein.
15. The medical device of claim 1 , wherein the tunnel member comprises a detachable section having a region of reduced tensile strength, such that application of a tensile force causes detachment of the detachable section.
16. A medical device for occupying a space within a patient's body, the medical device comprising:
a device body defining a reservoir;
a tunnel member comprising a first open end located within the reservoir and a second open end, the tunnel member having at least two interior opposing flexible membranes each having a surface that define a tunnel lumen extending between the first open end and the second open end;
a fluid delivery conduit that allows transport of a fluid into the reservoir, the fluid delivery conduit extending into the second open end of the tunnel member through to at least the first open end;
where the tunnel lumen is sized to slidably receive the fluid delivery conduit within the second open end such that the fluid delivery conduit separates the interior opposing surfaces and where the tunnel member assumes an axial profile similar to a portion of the fluid delivery conduit placed therein allowing the fluid delivery conduit to transport the fluid into the reservoir wherein upon removal of the fluid delivery conduit the at least two interior opposing surfaces of the tunnel member flatten without providing support to the tunnel member such that the tunnel member is unable to maintain a straight profile or the axial profile and collapses to a second-arcuate profile; and
a substance adjacent to the at least two interior opposing surfaces of the tunnel member, such that upon removal of the fluid delivery member, a cohesion of the substance causes the at least two interior opposing surfaces of the tunnel member to stick together increasing a force required to separate the at least two interior opposing surfaces and increasing a resistance to fluid flow through the tunnel lumen; and
where the device body, tunnel member, and a portion of the fluid delivery conduit located within the tunnel member can be compressed to fit within an oral dosage form to allow ingestion or swallowing of the medical device.
17. The medical device of claim 16 , where the fluid delivery member extends within the tunnel member such that the at least two interior opposing surfaces of the tunnel member hold the fluid delivery member in place by friction until withdrawn by pulling of the fluid delivery member.
18. The medical device of claim 16 , wherein the substance comprises a viscous material.
19. The medical device of claim 16 , further comprising at least one pocket in fluid communication with the tunnel lumen where the at least one pocket is configured to retain the substance therein.