Cell collection and preparation devices and methods

Abstract

According to exemplary embodiments of the present disclosure, a system for collection and analysis of cells from a body lumen of a patient may include a diagnostics device including a tube having a distal end and a proximal end and a balloon having a first end coupled to the distal end of the tube. The balloon may be disposed in the tube in a first, inverted position and movable to a second, everted position. A push wire may have a distal end coupled to a second end of the balloon. The balloon may be movable from the first inverted position to the second everted position by actuation of the push wire. One or more receptacles may be included for processing a balloon sample. The system may further include at least one of a sample preparation fluid, a sample preservation liquid, or both. The sample may be preparable for cytological analysis.

What is claimed is: 
     
         1 . A system for collection and analysis of cells from a body lumen of a patient, comprising:
 a diagnostics device including a tube having a distal end and a proximal end, a balloon having a first end coupled to the distal end of the tube, the balloon being disposed in the tube in a first, inverted position and movable to a second, everted position, and a push wire having a distal end coupled to a second end of the balloon, wherein the balloon is movable from the first inverted position to the second everted position with actuation of the push wire;   one or more receptacles for processing a balloon sample; and   at least one of a sample preparation fluid, a sample preservation liquid, or both;   wherein the balloon sample is preparable for cytological analysis.   
     
     
         2 . The system according to  claim 1 , wherein in the second, everted position a surface of the balloon is contactable with an inner surface of the body lumen to collect a plurality of cells, the balloon and the collected cells being separable from the diagnostics device for the balloon sample. 
     
     
         3 . The system according to  claim 2 , wherein the diagnostics device further includes a sheath coaxial with the tube and slidably adjustable relative to the tube to cover at least a first length of the balloon extending outward from the distal end of the tube in the second, everted position. 
     
     
         4 . The system according to  claim 2 , wherein the diagnostics device further includes a filament extendable distally of the first end of the balloon. 
     
     
         5 . The system according to  claim 4 , wherein the balloon and/or the filament is/are separable into the one or more receptacles for processing the balloon sample and/or a filament sample for cytological analysis of the collected cells. 
     
     
         6 . The system according to  claim 2 , further comprising a compiled cell library, wherein the cytological analysis of the collected cells are analyzable against the compiled cell library. 
     
     
         7 . The system according to  claim 6 , wherein the cytological analysis of the collected cells is performable for a plurality of patients and are compilable into the cell library. 
     
     
         8 . The system according to  claim 7 , wherein the cells from the plurality of patients are sequenceable such that genetic code information from the sequenced cells for each of the plurality of patients is determinable, wherein the genetic code information is compilable for the plurality of patients into a genetic code library. 
     
     
         9 . The system according to  claim 7 , wherein a treatment, a clinical outcome, or both, of a selected patient from the plurality of patients is determinable with the collected cells from the selected patient and the cell library. 
     
     
         10 . The system according to  claim 9 , wherein the collected cells from the plurality of patients form an array. 
     
     
         11 . A system for collection and analysis of cells from a body lumen of a patient, comprising:
 a diagnostics device including a tube having a distal end and a proximal end, a retraction marker disposed on the tube, a balloon having a first end coupled to the distal end of the tube, the balloon being disposed in the tube in a first, inverted position and movable to a second, everted position, and a push wire having a distal end coupled to a second end of the balloon, wherein the balloon is movable from the first inverted position to the second everted position by actuation of the push wire, wherein the diagnostics device further includes a sheath coaxial with the tube and slidably adjustable relative to the tube to cover in at least a partially everted position at least a first length of the balloon extending outward from the distal end of the tube, and wherein the retraction marker is positioned to allow the user to visualize and confirm that the balloon is protected by the sheath;   one or more receptacles for processing a balloon-collected cell sample; and   at least one of a sample preparation fluid, a sample preservation liquid, or both;   wherein the balloon-collected cell sample is preparable for cytological analysis.   
     
     
         12 . The system according to  claim 11 , wherein in the second, everted position a surface of the balloon is contactable with an inner surface of the body lumen to collect a plurality of cells, the balloon and the collected cells being separable from the diagnostics device for the processing of the balloon-collected cell sample. 
     
     
         13 . The system according to  claim 12 , wherein the diagnostics device further includes a filament extendable distally of the first end of the balloon. 
     
     
         14 . The system according to  claim 13 , wherein the balloon and/or the filament is/are separable into the one or more receptacles for processing the balloon-collected cell sample and/or a filament-collected cell sample, or combinations thereof, for cytological analysis of the collected cells. 
     
     
         15 . The system according to  claim 14 , further comprising a centrifuge wherein the balloon-collected cell sample, the sheath-collected cell sample, or the filament-collected cell sample, or combinations thereof is/are spun in the one or more receptacles. 
     
     
         16 . The system according to  claim 12 , further comprising a compiled cell library, and wherein the cytological analysis of the collected cells are analyzable with reference to the compiled cell library. 
     
     
         17 . The system according to  claim 16 , wherein the cytological analysis of the collected cells is performable for a plurality of patients and the cell library can compile the cytological analysis. 
     
     
         18 . The system according to  claim 17 , wherein the cells from the plurality of patients are sequenceable such that genetic code information from the sequenced cells for each of the plurality of patients is determinable, further comprising a genetic code library wherein the genetic code information is compilable for the plurality of patients. 
     
     
         19 . A system for collection and analysis of cells from a body lumen of a patient, comprising:
 a diagnostics device including a tube having a distal end and a proximal end, a balloon having a first end coupled to the distal end of the tube, the balloon being disposed in the tube in a first, inverted position and movable to a second, everted position, and a push wire having a distal end coupled to a second end of the balloon, wherein the balloon is movable from the first inverted position to the second everted position by actuation of the push wire;   one or more receptacles for processing a balloon sample; and   at least one of a sample preparation fluid, a sample preservation liquid, or both;   wherein the balloon sample is preparable for cytological analysis; and   wherein the balloon is separable from the diagnostics device for the balloon sample.   
     
     
         20 . The system of  claim 19 , further comprising one or more markers disposed on the balloon that indicate potential locations to separate the balloon.