US 11,986,235 B2
Systems, methods and devices for treatment of target tissue
Jay Caplan, Belmont, MA (US); Philip S. Levin, Storrs, CT (US); R. Maxwell Flaherty, Auburndale, FL (US); and J. Christopher Flaherty, Auburndale, FL (US)
Assigned to Fractyl Health, Inc., Lexington, MA (US)
Appl. No. 14/917,243
Filed by Fractyl Health, Inc., Lexington, MA (US)
PCT Filed Sep. 12, 2014, PCT No. PCT/US2014/055514
§ 371(c)(1), (2) Date Jul. 12, 2016,
PCT Pub. No. WO2015/038973, PCT Pub. Date Mar. 19, 2015.
Claims priority of provisional application 61/877,083, filed on Sep. 12, 2013.
Prior Publication US 2016/0354144 A1, Dec. 8, 2016
Int. Cl. A61B 18/14 (2006.01); A61B 8/12 (2006.01); A61B 18/00 (2006.01)
CPC A61B 18/1492 (2013.01) [A61B 8/12 (2013.01); A61B 2018/00023 (2013.01); A61B 2018/00041 (2013.01); A61B 2018/00166 (2013.01); A61B 2018/0022 (2013.01); A61B 2018/00482 (2013.01); A61B 2018/00494 (2013.01); A61B 2018/00577 (2013.01); A61B 2018/00714 (2013.01)] 23 Claims
OG exemplary drawing
 
1. A system for treating a patient comprising:
an elongate shaft comprising a distal portion, a proximal portion, and a single fluid exchange lumen therebetween having a single lumen attachment port, wherein the elongate shaft is constructed and arranged to be introduced into a duodenum of the patient;
an expandable reservoir positioned on the elongate shaft distal portion, wherein the expandable reservoir is constructed and arranged to receive a fixed amount of an ablative fluid from the single fluid exchange lumen and to deliver first and second thermal doses of energy to first and second portions of target tissue comprising duodenal mucosa, wherein the expandable reservoir has a tubular or round shape with a relatively uniform diameter configured to contact a wall of the patient's duodenum when expanded;
a fluid delivery assembly comprising a pumping assembly, a manifold, and a single manifold attachment port connecting the pumping assembly to the expandable reservoir via the single lumen attachment port and the single fluid exchange lumen; and
an energy delivery unit (EDU) including an ablative fluid reservoir and an evacuation reservoir which are fluidly connected to the manifold and the pumping assembly, wherein the ablative fluid reservoir and the evacuation reservoir are separate from each other;
a timer assembly, wherein the timer assembly is configured to control the manifold to selectively (1) deliver the ablative fluid from the ablative fluid reservoir sequentially through the pumping assembly, the single manifold attachment port, the single lumen attachment port, and the single fluid exchange lumen to the expandable reservoir and (2) remove the ablative fluid from the expandable reservoir sequentially through the single fluid exchange lumen, the single lumen attachment port, the single manifold attachment port, and the pumping assembly to the evacuation reservoir;
wherein the ablative fluid reservoir is configured to provide at least first and second fixed amounts of the ablative fluid to the fluid delivery assembly and the evacuation reservoir is configured to receive the at least first and second fixed amounts of the ablative fluid from the fluid delivery assembly; and
wherein the first and second fixed amounts of the ablative fluid may be delivered to and removed from the expandable reservoir to sequentially deliver the first and second thermal doses of energy to the first and second portions of target tissue comprising the duodenal mucosa.