TISSUE EXPANSION DEVICES, SYSTEMS AND METHODS
A device for expanding tissue comprises at least one fluid delivery tube and at least one fluid delivery element in fluid communication with the at least one fluid delivery tube. The at least one fluid delivery tube comprises a proximal end, a distal end, and a lumen therebetween. The device is constructed and arranged to perform a near full circumferential expansion of luminal wall tissue. Systems and methods are also provided, including a system for expanding tissue layers and treating tissue proximate to the expanded tissue layers.
1 - 12 . (canceled)
13 . A device for expanding tissue comprising:
an elongate shaft;
at least one fluid delivery tube comprising a proximal end, a distal end and a lumen therebetween, wherein the elongate shaft has a distal end that surrounds at least part of the at least one fluid delivery tube;
at least two hollow fluid delivery needles in fluid communication with the lumen of the at least one fluid delivery tube; and
an expandable support having a recess constructed and arranged to slidingly receive a hollow fluid delivery needle of the at least two hollow fluid delivery needles;
wherein the at least two hollow fluid delivery needles-are constructed and arranged to deliver fluid into luminal wall tissue.
14 . The device of claim 13 , wherein the device is configured to expand tissue in the duodenum and the elongate shaft is configured to be inserted through a mouth and has a working length greater than or equal to 100 cm.
15 . The device of claim 13 , wherein the at least one fluid delivery tube comprises a first fluid delivery tube and a second fluid delivery tube, and wherein the at least two hollow fluid delivery needles comprise a first hollow fluid delivery needle fluidly connected to the first fluid delivery tube and a second hollow fluid delivery needle fluidly connected to the second fluid delivery tube.
16 . The device of claim 13 , wherein the at least one fluid delivery tube comprises a first fluid delivery tube, and wherein the at least two hollow fluid delivery needles comprise a first hollow fluid delivery needle fluidly connected to the first fluid delivery tube and a second hollow fluid delivery needle fluidly connected to the first fluid delivery tube.
17 . The device of claim 16 , further comprising a fluid dispersion manifold coupled between the at least one fluid delivery tube and the at least two hollow fluid delivery needles.
18 . The device of claim 13 , wherein the at least two hollow fluid delivery needles comprise a circumferential array of at least three fluid delivery elements.
19 . The device of claim 13 , wherein the at least two hollow fluid delivery needles comprise at least three hollow fluid delivery needles equally spaced along a circumference.
20 . The device of claim 13 , wherein at least one said hollow fluid delivery needle of the at least two hollow fluid delivery needles comprises an advanceable fluid delivery element.
21 . The device of claim 20 , further comprising a surface positioned to limit the advancement of the at least one hollow fluid delivery needle.
22 . The device of claim 13 , further comprising a spring-loaded hollow fluid delivery needle advancement assembly coupled to the at least two hollow fluid delivery needles.
23 . The device of claim 22 , wherein the spring-loaded hollow fluid delivery needle advancement assembly is constructed and arranged to simultaneously advance multiple hollow fluid delivery needles.
24 . The device of claim 13 , further comprising a pressure sensor, wherein the device is constructed and arranged to monitor pressure prior to, during and/or after the delivery of fluid into the luminal wall tissue.
25 . The device of claim 13 , wherein the expandable support comprises an element selected from the group consisting of: at least one balloon; two or more support arms; a radially deployable structure; and combinations thereof.
26 . The device of claim 13 , wherein the expandable support is configured to apply a vacuum to each recess.
27 . The device of claim 13 , further comprising a vacuum source configured to bring the elongate shaft in contact with tissue.
28 . The device of claim 13 , wherein the recess comprises an axial length up to 5 mm and/or width up to 2 mm.