Treatment systems, small volume applicators, and methods for treating submental tissue

Abstract

Systems for treating a subject's tissue can include a thermally conductive cup, a tissue-receiving cavity, and a vacuum port. The vacuum port is in fluid communication with the tissue-receiving cavity to provide a vacuum for drawing the submental tissue, or other targeted tissue, into the tissue-receiving cavity. A thermal device can cool and/or heat the conductive cup such that the conductive cup non-invasively controls the temperature of subcutaneous lipid-rich cells in the tissue. A restraint apparatus can hold a the conductive cup in thermal contact with the target region.

1 . An apparatus for treating a subject's submental tissue, comprising:
 a thermally conductive cup including a first sidewall, a second sidewall, and a bottom;   a tissue-receiving cavity;   at least one vacuum port in fluid communication with the tissue-receiving cavity to provide a vacuum for drawing the submental tissue into the tissue-receiving cavity, wherein the tissue-receiving cavity is sufficiently shallow to allow the subject's submental tissue to occupy substantially the entire tissue-receiving cavity when the vacuum is drawn via the at least one vacuum port; and   a thermal device in thermal communication with the conductive cup, wherein the thermal device is configured to cool the conductive cup such that the first sidewall, the second sidewall, and the bottom together non-invasively cool subcutaneous lipid-rich cells in the submental tissue an amount sufficient to be biologically effective in damaging and/or reducing the subcutaneous lipid-rich cells.   
     
     
         2 . The apparatus of  claim 1  wherein each of the first sidewall, the second sidewall, and the bottom is positioned to absorb heat from the submental tissue to damage and/or reduce the lipid-rich cells, which are in a subcutaneous layer of adipose tissue, in number and/or size to an extent while non-lipid-rich cells deeper than the subcutaneous layer of adipose tissue are not reduced in number and/or size to the extent. 
     
     
         3 . The apparatus of  claim 1 , further comprising
 a pressurization device in fluid communication with the tissue-receiving cavity via the vacuum port; and   a controller with instructions for causing the apparatus to hold the submental tissue in the tissue-receiving cavity using suction provided by the pressurization device while the conductive cup conductively cools the subject's tissue.   
     
     
         4 . The apparatus of  claim 1  wherein the conductive cup includes a metal surface that faces the tissue-receiving cavity and has an area equal to or less than about 40 cm 2 . 
     
     
         5 . The apparatus of  claim 1  wherein the tissue-receiving cavity has a length between opposing end walls of the conductive cup, a width between the first and second sidewalls, and a depth between an opening of the tissue-receiving cavity and the bottom of the conductive cup, wherein the depth is substantially uniform along most of the length of the tissue-receiving cavity. 
     
     
         6 . The apparatus of  claim 1 , further comprising a restraint apparatus configured to hold a subject's head, wherein the restraint apparatus includes
 an adjustable pillow including a head cradle portion and being operable to controllably adjust tilt of the subject's head supported by the head cradle portion; and   at least one restraint coupleable to the pillow such that the at least one restraint holds the conductive cup in thermal contact with the subject's submental region while the subject's head is supported by the head cradle portion.   
     
     
         7 . An apparatus for treating a subject's tissue, comprising:
 a submental vacuum applicator including
 a tissue-receiving cavity, 
 a contoured lip defining a mouth of the tissue-receiving cavity and including a first arcuate lip portion and a second arcuate lip portion, wherein the contoured lip is configured to engage a submental area of the subject such that mostly submental tissue of the subject extends through the mouth and fills substantially all of the tissue-receiving cavity while the submental vacuum applicator draws a vacuum and the first and second arcuate lip portions surround at least a portion of the subject's body, and 
 a thermal device positioned to be in thermal contact with the submental tissue in the tissue-receiving cavity such that the thermal device is operable to non-invasively cool subcutaneous lipid-rich cells in the submental tissue an amount sufficient to be biologically effective in damaging and/or reducing the subcutaneous lipid-rich cells. 
   
     
     
         8 . The apparatus of  claim 7 , further comprising a controller with instructions for causing the thermal device to cool a conductive cup of the submental vacuum applicator such that the submental vacuum applicator non-invasively cools the subcutaneous lipid-rich cells to a temperature less than about 0° C. 
     
     
         9 . The apparatus of  claim 7  wherein the tissue-receiving cavity includes a first end, a second end, and a central section extending between the first and second ends, and wherein the central section has a curved longitudinal axis and a substantially uniform maximum depth along most of the curved longitudinal axis. 
     
     
         10 . The apparatus of  claim 9  wherein the curved longitudinal axis has the same curvature as a curvature of at least one of the first and second arcuate lip portions. 
     
     
         11 . The apparatus of  claim 7  wherein the tissue-receiving cavity has a substantially uniform maximum depth along most of a longitudinal length of the tissue-receiving cavity. 
     
     
         12 . The apparatus of  claim 7 , further comprising a vacuum source fluidically coupled to the tissue-receiving cavity and configured to provide sufficient vacuum to draw the submental tissue to a bottom of the tissue-receiving cavity to bring the submental tissue into thermal contact with a concave metal heat-exchanging surface of the submental vacuum applicator. 
     
     
         13 . The apparatus of  claim 7  wherein the submental vacuum applicator includes an applicator unit and a liner assembly removably attached to the applicator unit. 
     
     
         14 . A method of non-invasively cooling a submental region of a subject, the method comprising:
 placing a submentum applicator on the subject, wherein the submentum applicator includes a vacuum cup and a tissue-receiving cavity;   drawing submental tissue through the tissue-receiving cavity and into thermal contact with a section of the vacuum cup located at a bottom of the tissue-receiving cavity; and   conductively extracting heat from the submental tissue to the submentum applicator so as to cool the submental tissue an amount sufficient to be biologically effective in selectively damaging and/or reducing subcutaneous submental lipid-rich cells.   
     
     
         15 . The method of  claim 14  wherein conductively extracting heat from the submental tissue causes damage to and/or reduction of a sufficient amount of the submental subcutaneous lipid-rich cells to visibly reduce a double chin of the subject. 
     
     
         16 . The method of  claim 14 , further comprising
 supporting the subject's head on an adjustable pillow, wherein the adjustable pillow includes a deployable head cradle portion and is capable of controllably adjusting the forward tilt of a subject's head supported by the head cradle portion; and   holding the submentum applicator in thermal contact with the submental region using at least one restraint coupled to the pillow.   
     
     
         17 . A system for treating a subject, comprising:
 a restraint apparatus configured to hold a subject's head and including
 an adjustable pillow including a head cradle portion, wherein the adjustable pillow is operable to controllably adjust tilt of the subject's head supported by the head cradle portion; and 
 at least one restraint coupleable to the adjustable pillow such that the at least one restraint holds a tissue-cooling apparatus in thermal contact with the subject's submental region while the subject's head is supported at a desired angle by the head cradle portion 
   
     
     
         18 . The system of  claim 17 , further comprising the tissue-cooling apparatus, wherein the at least one restraint and the adjustable pillow are configured to cooperate to inhibit movement of the tissue-cooling apparatus relative to the subject's submental region while the tissue-cooling apparatus non-invasively cools subcutaneous lipid-rich cells at the subject's submental region an amount sufficient to be biologically effective in damaging and/or reducing the subcutaneous lipid-rich cells. 
     
     
         19 . The system of  claim 17  wherein the restraint apparatus further comprises
 a head adjuster device operable to reconfigure the head cradle portion to achieve the desired tilt of the subject's head; and 
 a neck adjuster device independently operable to reconfigure a neck support portion of the adjustable pillow to achieve desired neck tilt of the subject. 
 
     
     
         20 . The system of  claim 17  wherein the restraint apparatus further includes
 a cradle adjuster device with a first expandable element that expands a sufficient amount to tilt the head cradle portion and increase forward tilt of the subject's head; and 
 a neck adjuster device with a second expandable element that independently expands so as to cause a neck support portion of the pillow to push against a posterior region of the subject's neck. 
 
     
     
         21 . (canceled)