Ingestible capsule device for collecting fluid aspirates

Abstract

An ingestible capsule device collects fluid aspirates from locations within the body, locations such as the small intestine, and retains the fluid aspirates free from contamination as the capsule device is expelled from the body. The device allows for microbial and metabolomics analysis for a variety of gastrointestinal, allergic, endocrinologic, and oncologic diseases. In some examples, the capsule device is a multi-stroke device that includes a capsule shell and two reservoirs located within the shell. Check valves work in conjunction with a vacuum pressure pumping mechanism to control fluid movement from one reservoir to another, where one of the reservoirs may be expandable and permeable to some fluids. In other examples, the capsule device employs a peristaltic pump fluid control with the capsule device, and a single semi-permeable bladder stores collected fluid aspirate.

1 .- 22 . (canceled) 
     
     
         23 . An ingestible multi-stroke capsule device comprising:
 a capsule shell having an inlet for receiving a fluid into a first reservoir in the capsule device during an intake stroke;
 a first check valve positioned in fluid communication with the inlet and configured to controllably pass the fluid into the first reservoir during the intake stroke, in response to actuation by vacuum pressure pumping mechanism in the capsule device; 
   a second reservoir in the capsule device, the second reservoir in fluid communication with the first reservoir through a second check valve configured to pass fluid accumulated in the first reservoir, over one or more intake strokes, into the second reservoir during an exhaust stroke and in response to actuation by the vacuum pressure pumping mechanism,   wherein the first check valve and the second check valve are simultaneously controlled by the vacuum pressure pumping mechanism to block fluid from passing from the second reservoir into the first reservoir during operation of the capsule device.   
     
     
         24 . The ingestible multi-stroke capsule device of  claim 23 , wherein the second reservoir is permeable to some fluids. 
     
     
         25 . The ingestible multi-stroke capsule device of  claim 24 , wherein the second reservoir includes a bellows made from an electrospun polymer that is permeable to some fluids. 
     
     
         26 . The ingestible multi-stroke capsule device of  claim 23 , wherein the second reservoir is expandable within the capsule shell. 
     
     
         27 . The ingestible multi-stroke capsule device of  claim 23 , wherein the second reservoir has (i) a receiving end adjacent the first reservoir and configured such that the receiving end is maintained in a fixed position relative to the first reservoir and (ii) a distal end expandable in response to increases in fluid in the second reservoir. 
     
     
         28 . The ingestible multi-stroke capsule device of  claim 23 , wherein the second reservoir has a maximum volume equal to or greater than one cubic centimeter. 
     
     
         29 . The ingestible multi-stroke capsule device of  claim 23 , further including a controller connected to a battery and to the vacuum pressure pumping mechanism. 
     
     
         30 . The ingestible multi-stroke capsule device of  claim 29 , wherein the controller includes a collection mode program that, when activated, causes the vacuum pressure pumping mechanism to move continuously between the intake stroke and the exhaust stroke, opens the first check valve and closes the second check valve during the intake stroke, and closes the first check valve and opens the second check valve during the exhaust stroke. 
     
     
         31 . The ingestible multi-stroke capsule device of  claim 30 , wherein the controller is further connected to a timer, and the timer activates the collection mode program. 
     
     
         32 . The ingestible multi-stroke capsule device of  claim 30 , wherein the controller is further connected to a sensor disposed on the capsule shell, and a condition sensed by the sensor activates the collection mode program. 
     
     
         33 . The ingestible multi-stroke capsule device of  claim 32 , wherein the sensor is a pH sensor. 
     
     
         34 . The ingestible multi-stroke capsule device of  claim 32 , wherein the sensor is a an impedance sensor. 
     
     
         35 . The ingestible multi-stroke capsule device of  claim 33 , wherein the condition sensed by the pH sensor is a pH level between 5.5 and 8.0. 
     
     
         36 . The ingestible multi-stroke capsule device of  claim 30 , wherein the collection mode program runs for a set period of time. 
     
     
         37 . The ingestible capsule device of  claim 30 , wherein the collection mode program runs multiple times. 
     
     
         38 . The ingestible capsule device of  claim 37 , wherein the multiple times the collection mode program runs are at predetermined intervals. 
     
     
         39 . The ingestible multi-stroke capsule device of  claim 29 , wherein the controller includes a wireless receiver for receiving a wireless signal that activates the controller to at least one of: initiate the intake stroke, initiate the exhaust stroke, open the first check valve, close the first check valve, open the second check valve, and close the second check valve. 
     
     
         40 . The ingestible multi-stroke capsule device of  claim 39 , further including a remote wireless transmitter for transmitting a wireless signal that activates the controller to at least one of: initiate the intake stroke, initiate the exhaust stroke, open the first check valve, close the first check valve, open the second check valve, and close the second check valve. 
     
     
         41 . The ingestible multi-stroke capsule device of  claim 40 , wherein the collection mode program is activated by a signal transmitted from the remote wireless transmitter to the wireless receiver. 
     
     
         42 . The ingestible multi-stroke capsule device of  claim 23 , wherein the vacuum pressure pumping mechanism includes a diaphragm providing a movable casing for the first reservoir. 
     
     
         43 . The ingestible multi-stroke capsule device of  claim 31 , wherein the vacuum pressure pumping mechanism includes a magnetic solenoid driver configured to controllably move the diaphragm between an intake stroke position and an exhaust stroke position. 
     
     
         44 . The ingestible multi-stroke capsule device of  claim 31 , wherein the vacuum pressure pumping mechanism comprises a spring. 
     
     
         45 . The ingestible multi-stroke capsule device of  claim 31 , wherein the vacuum pressure pumping mechanism comprises a gear mechanism. 
     
     
         46 . The ingestible multi-stroke capsule device of  claim 31 , wherein the diaphragm is bistable. 
     
     
         47 . The ingestible multi-stroke capsule device of  claim 30 , wherein the controller includes a contamination resistance mode program that when activated, closes the first check valve, closes the second check valve, and stops movement of the pumping mechanism. 
     
     
         48 . The ingestible multi-stroke capsule device of  claim 47 , wherein the contamination resistance mode is activated by cessation of the collection mode program. 
     
     
         49 . The ingestible multi-stroke capsule device of  claim 47 , wherein the contamination resistance mode is activated by a signal transmitted from the remote wireless transmitter to the wireless receiver.