Transformable tissue bulking device
A medical device and methods for filling tissue are disclosed. The device is transformable between a first configuration wherein the device can pass through a small catheter or needle placed in the tissue to be filled and a second configuration in which the device is enlarged within the tissue to be filled. The exterior profile of the expanded device may be customized along its length to achieve a desired result. In one embodiment, the device comprises an outer sleeve having a filler. The device may be used to reduce facial wrinkles or augment facial features such as the lips.
1 . A tissue filling device having a first configuration and a second configuration, wherein the first configuration is adapted to fit through a tubular access channel and the second configuration is adapted to fill tissue with a tissue augmenting size and shape and where said device is transformable from the first configuration to the second configuration by introduction of a filler into the device following delivery of the device into said tissue through the tubular channel.
2 . The device in claim 1 where the device comprises a flexible polymeric tube.
3 . The device in claim 1 where the filler comprises shape memory wire.
4 . The device in claim 1 where the filler comprises a plurality of coils.
5 . The device in claim 1 where the filler is a liquid.
6 . The device in claim 1 where the filler is a gel.
7 . The device in claim 1 where the filler comprises beads suspended in a liquid.
8 . The device in claim 1 where filler is polymerizable in situ.
9 . The device in claim 1 where the filler is a cross-linked in situ.
10 . The device in claim 1 where the filler changes viscosity in situ.
11 . The device in claim 1 where the distal and proximal ends are softer than the mid portion.
12 . The device in claim 1 where the device comprises a balloon.
13 . The device in claim 1 where the second configuration has a flattened cross section.
14 . The device in claim 1 where the device is at least partially covered with a polymer.
15 . The device in claim 1 where the device is at least partially covered with e-PTFE.
16 . The device in claim 1 where the device is at least partially covered with a laminate of e-PTFE and a thermoplastic.
17 . The device in claim 1 where the device is at least partially covered with a laminate of e-PTFE and polyethylene.
18 . The device in claim 1 where the device is at least partially covered with a polymer layer having a thickness between about 0.001 and about 0.010″.
19 . The device in claim 1 where the device is at least partially covered with two sheets of polymer bound together such that a chamber is formed therebetween.
20 . The device in claim 1 where the device is covered with two sheets of polymer bound to a Nitinol frame such that a chamber is formed therebetween.
21 . The device in claim 1 where the device is covered with a polymer and the polymer is supported by a metallic frame.
22 . The device in claim 1 where the device is covered with a polymer and the polymer is supported by a Nitinol frame.
23 . The device of claim 1 where the tubular channel is a needle.
24 . The device of claim 1 where the tubular channel is a catheter.
25 . The device of claim 1 where the tubular channel is a cannula.
26 . The device of claim 1 where the tubular channel has a noncircular cross section.
27 . The device in claim 1 where the tissue is the skin.
28 . The device in claim 1 where the tissue is the gastro-esophageal junction.
29 . The device in claim 1 where the tissue is the myocardium.
30 . The device in claim 1 where the tissue is the stomach wall.
31 . The device in claim 1 where the tissue augmenting size and shape is configured to fill the tissue beneath nasolabial fold.
32 . The device in claim 1 where the tissue augmenting size and shape is configured to enhance the upper lip.
33 . The device in claim 1 where the tissue augmenting size and shape is configured to enhance the right half of the upper lip.
34 . The device in claim 1 where the tissue augmenting size and shape is configured to enhance the left half of the upper lip.
35 . The device in claim 1 where the tissue augmenting size and shape is configured to enhance the lower lip.
36 . The device in claim 1 where the tissue augmenting size and shape is configured to fill the tissue beneath facial folds.
37 . The device in claim 1 where the tissue augmenting size and shape is configured to enlarge the cheeks.