U.S. patent application number 17/379547 was filed with the patent office on 2021-11-11 for ingestible capsule device for collecting fluid aspirates.
The applicant listed for this patent is UNIVERSITY OF MIAMI. Invention is credited to Alex Espinosa, Baharak Moshiree.
Application Number | 20210345904 17/379547 |
Document ID | / |
Family ID | 1000005724727 |
Filed Date | 2021-11-11 |
United States Patent
Application |
20210345904 |
Kind Code |
A1 |
Moshiree; Baharak ; et
al. |
November 11, 2021 |
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.
Inventors: |
Moshiree; Baharak;
(Charlotte, NC) ; Espinosa; Alex; (Miami,
FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
UNIVERSITY OF MIAMI |
Miami |
FL |
US |
|
|
Family ID: |
1000005724727 |
Appl. No.: |
17/379547 |
Filed: |
July 19, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16082009 |
Sep 4, 2018 |
11064905 |
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PCT/US17/20728 |
Mar 3, 2017 |
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17379547 |
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62303917 |
Mar 4, 2016 |
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62303917 |
Mar 4, 2016 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/14546 20130101;
A61B 2010/0061 20130101; A61B 5/1451 20130101; A61B 10/0045
20130101; A61B 5/073 20130101; A61B 5/14539 20130101 |
International
Class: |
A61B 5/07 20060101
A61B005/07; A61B 10/00 20060101 A61B010/00; A61B 5/145 20060101
A61B005/145 |
Claims
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.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] The priority benefit of U.S. Provisional Patent Application
No. 62/303,917, filed Mar. 4, 2016, and entitled "Ingestible
Capsule Device for Collecting Fluid Aspirates" is claimed and the
entire contents thereof are incorporated by reference herein.
FIELD OF THE DISCLOSURE
[0002] This disclosure relates generally to an ingestible capsule
device, and more specifically, to an ingestible capsule device
capable of collecting fluid aspirates from the small intestine for
microbial and metabolite composition analysis.
BACKGROUND
[0003] The background description provided herein is for the
purpose of generally presenting the context of the disclosure. Work
of the presently named inventors, to the extent it is described in
this background section, as well as aspects of the description that
may not otherwise qualify as prior art at the time of filing, are
neither expressly nor impliedly admitted as prior art against the
present disclosure.
[0004] Disturbances in the homeostasis of the gastrointestinal (GI)
tract's microbiome, called intestinal dysbiosis, is associated with
many diseases such as diabetes, obesity, colon cancer, inflammatory
bowel diseases such as Crohn's disease and irritable bowel syndrome
(IBS). Traditionally, information about specifically the small
intestine's microbiome has been collected in one of two ways.
First, a catheter may be introduced into a patient via a fiberoptic
endoscope advanced to the small intestine to collect fluid if fluid
is present. This method is invasive and presents a number of risks,
namely the risk of perforation from insertion of the endoscope, the
risk of the introduction of infection by the endoscope itself, the
risk of bleeding, the risks of sedation, and the risk of
contamination by fluid aspirated from other portions of the
digestive track through which the catheter travels, such as the
mouth which is often full of oral bacteria. Alternatively, a less
accurate noninvasive test which is noninvasive can be performed via
a hydrogen breath test to indirectly detect the end products of
bacteria via assessment of CO2 and methane production by bacteria.
However, the breath test does not enable identification of the
actual pathogenic bacteria in the small intestine, which is
sometimes necessary for proper antibiotic treatment. This test is
commonly performed in patients who complain of abdominal pain,
bloating, diarrhea and otherwise unexplained chronic
gastrointestinal symptoms.
[0005] Ingestible capsule devices have previously been developed
for drug delivery purposes. However, such capsule devices do not
provide a means by which to gather fluid aspirates from the small
intestine or other locations within the body. Moreover, with
conventional ingestible devices, keeping collected fluid aspirates
free from contamination (e.g., as the capsule device is expelled
from the body) is a challenge. Gathering fluid aspirates from the
small intestine is particularly challenging, because the small
intestine is filled with air along with the fluid aspirates. As a
result, a capsule device may suction air instead of or in addition
to fluid aspirate depending on the position of the capsule device
within the small intestine.
SUMMARY OF THE DISCLOSURE
[0006] The current disclosure is directed to multiple embodiments
of an ingestible capsule device that can collect fluid aspirates
from locations within the body such as the small intestine and keep
the fluid aspirates free from contamination from the mouth or colon
as the capsule device is expelled from the body. To achieve these
ends, in some embodiments, the capsule device has a multi-stroke
intake process. The capsule device includes a capsule shell and has
two reservoirs located within the shell. The capsule shell has an
inlet for receiving fluid that is connected to the first reservoir.
A first check valve located between the inlet and the first
reservoir controllably passes fluid into the first reservoir during
an intake stroke in response to actuation by a vacuum pressure
pumping mechanism in the capsule device. The second reservoir is 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. 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, thus ensuring that the fluid aspirates gathered by the
capsule device do not become contaminated as the capsule device is
expelled from a patient's body.
[0007] In some multi-stroke embodiments within the scope of the
present disclosure, the second reservoir is expandable within the
capsule shell and is also expandable outside the capsule if, for
example, a portion of the capsule shell is digestible. For example,
the second reservoir may have 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 a distal
end expandable in response to increases in fluid in the second
reservoir. The second reservoir may be a bellows. The maximum
volume of the second reservoir may be equal to or greater than one
cubic centimeter.
[0008] Because air may sometimes be taken in during the intake
process of the capsule device, in some multi-stroke embodiments
within the scope of the present disclosure, the second reservoir of
the capsule device is permeable to some fluids. This allows air,
for example, to exit the second reservoir, providing more space for
desired fluids such as fluid aspirate from the small intestine. In
some multi-stroke embodiments within the scope of the present
disclosure, the second reservoir may be a bellows made from an
electrospun polymer that is permeable to some fluids.
[0009] The vacuum pressure pumping mechanism of a multi-stroke
device may include a diaphragm providing a movable casing for the
first reservoir. The diaphragm may be controllably moved between an
intake stroke position and an exhaust stroke position by a magnetic
solenoid driver. The vacuum pressure pumping mechanism may include
a spring or a gear mechanism, and the diaphragm may be
bistable.
[0010] In other embodiments within the scope of the present
disclosure, a positive displacement pumping device may be used,
e.g., having a peristaltic pumping mechanism that collects fluid
from within the body. In such examples, in place of the two
reservoirs, the capsule device may be implemented with a single
reservoir, within a shell for storing the fluid aspirate. The
peristaltic pump may be driven by a high rotation rate motor
(mini-motor), capable of rotating of 10,000, 20,000, 30,000 to
40,000 rotations per minute, by way of example. The peristaltic
pump rotates at a lower rotation rate, determined by a gear ratio,
and may continuously receive fluid collected from an inlet hole and
aspirate that fluid into the collection reservoir.
[0011] The capsule device may include a non-dissolvable cap that
houses the peristaltic pump, which may be mounted on a universal
mount. An inlet conduit of the peristaltic pump may extend through
the inlet hole in the non-dissolvable cap, and an outlet conduit of
the peristaltic pump may extend through an outlet hole in the
universal mount. The outlet conduit may extend into a single
permeable bladder. The permeable bladder may be extendable, in some
embodiments doubling or tripling in size, between an initial size
and fluid-filled size. A dissolvable cap may cover the permeable
bladder. The non-dissolvable cap and the dissolvable cap may be
configured such that together they form a shell that can easily be
swallowed. The dissolvable cap may be ejected several minutes after
swallowing during transit through the patient's body by the
expansion of the permeable bladder. The semi-permeable bladder may
be separable from the mount and may include a bladder seal to close
the semi-permeable bladder upon removal of the outlet conduit.
[0012] The peristaltic pump in the capsule device includes a stator
with a central aperture with a notched edge. A cycloid gear engages
the stator. An eccentric or cam-shaped crank is connected to the
center of the cycloid gear. A stator cover covers the stator and
cycloid gear, and an output disk is connected outside the stator
cover to the eccentric crank. Output pins extend from the output
disk and are connected to rollers. A media tubing is secured in an
arc-configuration by the stator cover. As the eccentric crank
turns, the rollers are alternately engaged and disengaged with the
media tubing. When engaged with the media tubing, the rollers pinch
the media tubing closed, thus forcing fluid within the media tubing
to move through the media tubing. When the rollers disengage the
media tubing, fluid flow is induced by the newly created vacuum to
flow through the media tubing. The media tubing may be configured
to overlap for a distance, and the peristaltic pump may be sealed
by stopping a roller within the distance where the media tubing
overlaps.
[0013] In both multi-stroke and peristaltic pump embodiments within
the scope of the present disclosure, the capsule device may include
a controller connected to a battery and to the pumping mechanism.
The controller comprises at least one computer processor and at
least one memory storing computer-readable instruction (e.g.,
program) that when executed causes the processor to perform the
various control functions described herein. The controller may have
a number of programs to ensure proper collection of fluid
aspirates. For example, in multi-stroke embodiments, the controller
may have 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. In multi-stroke embodiments, the
controller may have a contamination resistance mode program that,
when activated, closes the first check valve, closes the second
check valve, and stops movement of the vacuum pressure pumping
mechanism. In embodiments that are not multi-stroke, the controller
may simply have a collection mode program and off mode program with
the peristaltic pump running during the collection mode program and
turned off during the off mode program. The collection mode program
may run for a set period of time, may run multiple times, and may
run multiple times at predetermined intervals.
[0014] The collection mode program may be connected to a timer, and
the timer may activate the collection mode program. Alternately,
the controller may be connected to a sensor disposed on the capsule
shell or non-dissolvable cap, and a condition sensed by the sensor
may activate the collection mode program. For example, the pH level
within the human digestive track changes depending on the organ,
with the small intestine generally having a pH range of 5.5 to 8.0.
The sensor may be a pH sensor, and the condition sensed by the
sensor to activate the collection mode may be a specific pH range
such as 5.5 to 8.0. The pH in the stomach usually ranges between 1
and 4 and the pH in the colon is less than 5.5. The motor
controller may monitor the current drawn from the motor and
identify periods when a greater amount of current is drawn and
periods when a lesser amount of current is drawn within a cycle of
a peristaltic pump, and the collection mode program may wait for a
period when a greater amount of current is drawn to end the
collection mode program as this may indicate that a roller is
within a distance of overlapping media tubing, thereby sealing the
peristaltic pump.
[0015] In some embodiments within the scope of the present
disclosure, the controller includes a wireless receiver, and the
capsule device includes a remote wireless transmitter. In
multi-stroke embodiments, the wireless receiver may receive from
the remote wireless transmitter a signal that activates the
controller to initiate an intake stroke, initiate an exhaust
stroke, open or close the first check valve, and open or close the
second check valve. In both multi-stroke and non-multi-stroke
embodiments, the wireless receiver may receive from the remote
wireless transmitter a signal to active the collection mode
program. In multi-stroke embodiments, the wireless receiver may
receive from the remote wireless transmitter a signal to activate
the contamination resistance mode program. Alternately, the
contamination resistance mode program may be activated by cessation
of the collection mode program. In peristaltic pump embodiments,
the wireless receiver may receive from the remote wireless
transmitter a signal that either starts or stops the running of the
control motor and the peristaltic pump. Peristaltic pump
embodiments may further include a sample dispensation mode. In
sample dispensation mode, the action of the peristaltic pump may be
reversed to dispense the collected sample.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] FIG. 1 illustrates an isometric view of a multi-stroke
capsule device of the present disclosure with a capsule shell in a
closed position.
[0017] FIG. 2 illustrates an isometric view of a multi-stroke
capsule device of the present disclosure with a capsule shell in an
open position.
[0018] FIG. 3A illustrates a cross-sectional view of a multi-stroke
capsule device of the present disclosure during an intake stroke
when the diaphragm is closed and the first check valve and second
check valve are closed.
[0019] FIG. 3B illustrates a cross-sectional view of a multi-stroke
capsule device of the present disclosure during an intake stroke
when the diaphragm is opening and the first check valve is
opening.
[0020] FIG. 3C illustrates a cross-sectional view of a multi-stroke
capsule device of the present disclosure during an intake stroke
when the diaphragm is open and the first check valve is open.
[0021] FIG. 3D illustrates a cross-sectional view of a multi-stroke
capsule device of the present disclosure during an intake stroke
when the diaphragm is open and the first check valve is again
closed.
[0022] FIG. 4A illustrates a cross-sectional view of a multi-stroke
capsule device of the present disclosure during an exhaust stroke
when the diaphragm is open and the first check valve and the second
check valve are closed.
[0023] FIG. 4B illustrates a cross-sectional view of a multi-stroke
capsule device of the present disclosure during an exhaust stroke
when the diaphragm is closing and the second check valve is
opening.
[0024] FIG. 4C illustrates a cross-sectional view of a multi-stroke
capsule device of the present disclosure during an exhaust stroke
when the diaphragm is closed and the second check valve is
open.
[0025] FIG. 4D illustrates a cross-sectional view of a multi-stroke
capsule device of the present disclosure during an exhaust stroke
when the diaphragm is closed and the second check valve is again
closed.
[0026] FIG. 5 illustrates an isometric view of a multi-stroke
capsule device of the present disclosure when the second reservoir
is expanded.
[0027] FIG. 6 illustrates a cross-sectional view of a peristaltic
pump capsule device of the present disclosure.
[0028] FIG. 7 illustrates an exploded view of a peristaltic pump
capsule device of the present disclosure.
[0029] FIG. 8A illustrates an exploded isometric view of a
peristaltic pump for a capsule device of the present
disclosure.
[0030] FIG. 8B illustrates a top view of the peristaltic pump
illustrated in FIG. 8A.
[0031] FIG. 8C illustrates a cross-sectional view of the
peristaltic pump illustrated in FIG. 8A.
[0032] FIG. 9 illustrates an alternate arrangement of a peristaltic
pump for a capsule device of the present disclosure.
[0033] FIG. 10A illustrates a cross-sectional view of a peristaltic
pump capsule device of the present disclosure adapted to split in
half after completing collection of fluid aspirate.
[0034] FIG. 10B illustrates a cross-sectional view of the
peristaltic pump capsule device illustrated in FIG. 10A after the
peristaltic pump capsule device has split in half.
[0035] FIG. 11 illustrates a block diagram of a controller for a
capsule device of the present disclosure.
DETAILED DESCRIPTION
[0036] FIG. 1 illustrates a multi-stroke capsule device 2 of the
present disclosure. The capsule device 2 has a capsule shell 4
surrounding a vacuum pressure pumping mechanism 6. In the
embodiment depicted in FIG. 1, the vacuum pressure pumping
mechanism 6 includes a diaphragm 8 connected to an actuator coil
10. A controller 12 and a battery 14 are in communication with the
actuator coil 10 and are contained within an enclosure 16 in the
capsule shell 4.
[0037] FIG. 2 illustrates a multi-stroke capsule device 2 of the
present disclosure with a capsule shell 4 in an open position. An
inlet 18 of the multi-stroke capsule device 2 is visible. In the
embodiment depicted in FIG. 2, a second reservoir 26 is expandable
and the outside of the second reservoir 26 is visible.
[0038] FIGS. 3A-3D illustrate the intake stroke of a multi-stroke
collection mode program carried out by the multi-stroke capsule
device 2. FIG. 3A illustrates the multi-stroke capsule device 2 of
the present disclosure during an intake stroke when the diaphragm 8
is closed and the first check valve 20 and second check valve 22
are closed. No fluid is located in the first reservoir 24 or the
second reservoir 26.
[0039] FIG. 3B illustrates the multi-stroke capsule device 2 of the
present disclosure during an intake stroke when the diaphragm 8 is
opening and the first check valve 20 is opening. Fluid aspirate 28
enters (see, inlet and arrow) the first reservoir 24 through the
first check valve 20. The second check valve 22 is still closed,
and no fluid aspirate 28 is able to enter the second reservoir
26.
[0040] FIG. 3C illustrates the multi-stroke capsule device 2 of the
present disclosure during an intake stroke when the diaphragm 8 is
deflected to receiver the aspirate 28 and when the first check
valve 20 is open. Fluid aspirate 28 fills the first reservoir 24
through the first check valve 20. The second check valve 22 is
still closed, and no fluid aspirate 28 is entering the second
reservoir 26.
[0041] FIG. 3D illustrates the multi-stroke capsule device 2 of the
present disclosure at the end of an intake stroke when the
diaphragm 8 is fully deflected (also termed fully opened) and the
first check valve 20 is again closed. Fluid aspirate 28 fills the
first reservoir 24. The second check valve 22 is still closed, and
no fluid aspirate 28 is entering the second reservoir 26.
[0042] In the illustrated example, the diaphragm 8 moves between
the closed and fully open position using a control mechanism, in
particular a magnetic solenoid driver having a magnetic member
mounted to a back surface of the diaphragm 8 and attracted and
repelled in response to control from a fixed magnetic member
surrounded by the coil spring controlling the generated magnetic
field to selectively alternate between an intake stroke and an
exhaust stroke. Thus, in some examples, the control mechanism may
be a vacuum pressure pumping mechanism that includes the diaphragm
8 providing a movable casing for the first reservoir 24. In some
examples, this vacuum pressure pumping mechanism uses a gear
mechanism, an example of which is discussed further below. In some
examples, the vacuum pressure pumping mechanism is designed such
that the diaphragm is bistable.
[0043] FIGS. 4A-4B illustrate the exhaust stroke of a multi-stroke
collection mode program carried out by a multi-stroke capsule
device 2. FIG. 4A illustrates the multi-stroke capsule device 2 of
the present disclosure at the beginning of an exhaust stroke when
the diaphragm 8 is open and the first check valve 20 and the second
check valve 22 are closed. Because the beginning of an exhaust
stroke generally occurs at the same time as the end of an intake
stroke, FIGS. 3D and 4A are identical.
[0044] FIG. 4B illustrates the multi-stroke capsule device 2 of the
present disclosure during an exhaust stroke when the diaphragm 8 is
closing (expelling the aspirate 28) and the second check valve 22
is opening. The first check valve 20 is closed. Fluid aspirate 28
in the first reservoir 24 begins to move to the second reservoir 26
through the second check valve 22.
[0045] FIG. 4C illustrates the multi-stroke capsule device 2 of the
present disclosure during an exhaust stroke when the diaphragm 8 is
closing (expelling the aspirate 28) and the second check valve 22
is open. The first check valve 20 is closed. Fluid aspirate 28 in
the first reservoir 24 continues to move to the second reservoir 26
through the second check valve 22. If the second check valve 22 is
expandable, the second check valve 22 may begin to expand as fluid
aspirate 28 enters.
[0046] FIG. 4D illustrates the multi-stroke capsule device 2 of the
present disclosure during an exhaust stroke when the diaphragm 8 is
closed (e.g., fully deflected away from the magnetic solenoid of
the vacuum pumping pressure mechanism) and the second check valve
22 is again closed. The first check valve 20 is also closed. Fluid
aspirate 28 has exited the first reservoir 24 and is now stored in
the second reservoir 26.
[0047] FIG. 5 illustrates the multi-stroke capsule device 2 of the
present disclosure when the second reservoir 26 is expanded. The
second reservoir 26 may be a bellows, and the maximum volume of the
second reservoir 26 may be a cubic centimeter. In some embodiments,
the second reservoir 26 may be made from a material that is
permeable to some fluids, such as air. For example, the second
reservoir 26 may be made from an electrospun polymer. The ability
of the second reservoir 26 to expel air, through a permeable
membrane, allows the volume of the second reservoir 26 to be
reserved for collection of a desired fluid, such as fluid aspirates
from the small intestine. As the reservoir 26 fills with fluid
aspirate, air is pushed out through the membrane.
[0048] FIG. 6 depicts a cross-section of a capsule device 102
having a peristaltic pump 130. As shown in FIGS. 6-8C, the
peristaltic pump 130 is attached to a universal mount 148. Fluid
aspirate is drawn into the peristaltic pump through an inlet
conduit 150, travels through media tubing 144, and exits the
peristaltic pump through an outlet conduit 152. A permeable bladder
154 is connected to the universal mount 148, and the outlet conduit
152 extends through an outlet hole 156 in the universal mount 148
into the permeable bladder 154. Like the second reservoir 26
discussed above, the permeable bladder 154 may be a bellows, and
the maximum volume of permeable bladder 154 may be a cubic
centimeter. In some embodiments, the permeable bladder 154 may be
made from a material that is permeable to some fluids, such as air.
For example, the permeable bladder 154 may be made from an
electrospun polymer. The permeable bladder may have a receiving end
adjacent universal mount and configured such that the receiving end
is maintained in a fixed position relative to the universal mount
and a distal end expandable in response to increases in fluid in
the permeable bladder. The receiving end may be formed of a
hardened material and includes a sealable connection mechanism for
attaching to the universal mount 148. The expandable end is formed
of an expandable material such as an electrospun polymer. The
expandable material may be air permeable throughout the entire
bladder 154 or only permeable over portions thereof, e.g., around
the distal tip end or around the cylindrical sides of the bladder
154.
[0049] In operation, a motor 151 in the pump 130 controls operation
of a peristaltic pumping mechanism (see, FIG. 8). The motor 151
includes a controller that determines the timing and operation of
the pump 130. That controller, for example, may receive wireless
control signals from an external transmitter indicating to start
and/or stop the pump 130. An example controller is described below
in reference to FIG. 11. In some examples, that controller is
programmed to start and stop operation of the pump 130 at
predetermined times, e.g., at a time at which point the pill should
be digested into the desired location in the GI track (1 hour, 2
hours, 3 hours, 6 hours, 7 hours, etc.). In some examples, the
controller is responsive to a sensor in the device 102, such as a
pH sensor or impedance sensors electronically coupled to the motor
151 and controller.
[0050] In any event, as fluid is aspirated into the bladder 154
using the peristaltic pump 130, the bladder 154 fills and presses
against the cap 160 and eventually, after a certain fluid volume,
forces the cap 160 to fully disengage and release from the
assembly. In some examples, the bladder 154 is multilayer
structure, having a permeable inner expandable layer and an
expandable outer layer that is not permeable. Both these layers may
be retained within the cap 160. During a sample dispensation mode,
the direction of the pump 130 may be reversed so that fluid
aspirate collected in the bladder 154 is expelled from the capsule
device 102 through the inlet conduit 150.
[0051] A non-dissolvable cap 158 may surround the peristaltic pump
130 and, in conjunction with the universal mount 148, form a shell
with a dissolvable cap 160 that surrounds the permeable bladder
154. The dissolvable cap 160 may be impermeable in order to, for
example, maintain the shape of the permeable bladder 154 prior to
the capsule device 102 reaching the small intestine or location
from which fluid is to be collected. The dissolvable cap 160 may be
forced off the universal mount 148 by the permeable bladder 154 as
the permeable bladder 154 fills with fluid and expands. The
non-dissolvable cap 158 may include an inlet hole 162 through which
the inlet conduit 150 may extend. FIG. 7 depicts the capsule device
102 shown in FIG. 6 in an expanded view.
[0052] FIGS. 8A-8C illustrate various elements of the peristaltic
pump 130 that may be used as a vacuum pressure pumping mechanism 6.
FIG. 8A illustrates an exploded isometric view of the peristaltic
pump 130 for a capsule device 102 of the present disclosure. The
peristaltic pump 130 includes a stator 132. A cycloid gear 134
engages the stator 132. An eccentric or cam-shaped crank 136 is
connected to the center of the cycloid gear 134. A stator cover 138
covers the stator 132 and cycloid gear 134, and an output disk 140
is connected outside the stator cover 138 to the eccentric crank
136. Output pins 142 extend from the output disk 140 and are
connected to rollers 146. A media tubing 144 is secured in an
arc-configuration by the stator cover 138. As the eccentric crank
136 turns, the rollers 146 are alternately engaged and disengaged
with the media tubing 144. When engaged with the media tubing 144,
the rollers 146 pinch the media tubing 144 closed, thus forcing
fluid within the media tubing 144 to move through the media tubing
144. When the rollers 146 disengage the media tubing 144, fluid is
induced by the newly created vacuum to flow through the media
tubing 144.
[0053] FIG. 8B illustrates a top view of the peristaltic pump 130
illustrated in FIG. 8A. The output disk 140 surrounds output pins
142, which are connected to rollers 146. FIG. 8C illustrates a
cross-sectional view of the peristaltic pump 130 illustrated in
FIGS. 8A and 8B. The stator 132 is engaged with the cycloid gear
134. The eccentric crank 136 is centered, while the rollers 142 are
located around the eccentric crank 136.
[0054] FIG. 9 illustrates an alternate arrangement of the
peristaltic pump 130. As in FIG. 8B, the output disk surrounds
output pins 142, which are connected to rollers 146. The rollers
146 are alternately engaged and disengaged with the media tubing
144, thus forcing fluid within the media tubing 144 to move through
the media tubing 144. However, in FIG. 9, the media tubing overlaps
itself for a distance x. If a roller 146 is stopped within distance
x, the media tubing 144 is sealed such that no fluid can enter or
exit media tubing 144. The motor responsible for movement of the
rollers 146, such as motor 151 in FIG. 7, draws a higher current
when a roller is engaged with the overlapping portion of the media
tubing within distance x. By monitoring the current drawn by the
motor, a capsule device 102 can be programmed to stop the motor
when a roller is within distance x, such that the media tubing 144
is sealed. For example, the capsule device 102 may run the
collection mode program for a set period of time, may check the
amount of current being drawn by the motor, and may stop movement
of the motor when the a higher amount of current is being drawn,
which indicates that media tubing 144 is sealed by a roller
146.
[0055] FIG. 10A illustrates a cross-section of a capsule device 102
having a peristaltic pump 130 similar to that depicted in FIG. 6,
except that the capsule device 102 is adapted to be split in half
after collection of fluid aspirate in order to facilitate movement
through lower portions of the GI tract. As shown in FIG. 10A, the
outlet conduit 152 extends through the universal mount 148 into the
permeable bladder 154. A bladder seal 170 may surround the outlet
conduit 152 within the permeable bladder 154. The bladder seal 170
may be disposed to close, such as by a spring, but may be held open
by the outlet conduit 152 when the capsule device 102 is not split
into two pieces, e.g., in two halves. As shown in FIG. 10B, the
capsule device may be split by separating cap 158 from cap 160. The
separation of cap 158 and 160 may be controlled by a controller,
such as the controller in motor 151, and may occur after fluid
aspirate has been collected, for example, at the end of a
collection mode or any time after a collection mode has been
completed. The splitting of the capsule device 102 may occur as a
result of external mechanical forces acting on the capsule device
102 as the capsule device 102 travels through the GI tract.
Alternately, any known mechanical mechanism in the art (not herein
depicted), such as an actuable clip, may be connected to the motor
151 and used to achieve separation of cap 158 and 160. In some
examples, the controller in motor 151 may cause the separation of
cap 158 and 160 in response to a sensed change in pH, after a set
period of time, or in response to an external control such as a
wireless signal received by a wireless receiver. When the cap 158
separates from the cap 160, the outlet conduit is pulled out of the
permeable bladder 154, and the bladder seal 170 closes. This
protects the collected fluid aspirate from contamination as the
permeable bladder 154 is expelled.
[0056] FIG. 11 illustrates a block diagram of an example controller
200 (such as controller 12 or the controller associated with motor
141) that may be utilized in a capsule device. The controller 200
may include, for example, one more central processing units (CPUs)
or processors 202, and one or more busses or hubs 204 that connect
the processor(s) 202 to other elements of the controller 200, such
as a volatile memory 208, a non-volatile memory 210, a display
controller 212, and an I/O interface 206. The volatile memory 208
and the non-volatile memory 210 may each include one or more
non-transitory, tangible computer readable storage media such as
random access memory (RAM), read only memory (ROM), FLASH memory, a
biological memory, a hard disk drive, a digital versatile disk
(DVD) disk drive, etc.).
[0057] In an embodiment, the memory 208 and/or the memory 210 may
store instructions that are executable by the processor 202. For
example, in a capsule device particularly configured to perform the
techniques described herein, the instructions may be the
instructions executed by the capsule device, such as the processes
described herein. The illustrated controller 200 is only one
example of a controller suitable to be particularly configured for
use in a capsule device. Other embodiments of the controller 200
may also be particularly configured for use in a capsule device,
even if the other embodiments have additional, fewer, or
alternative components than shown in FIG. 11, have one or more
combined components, or have a different configuration or
arrangement of the components. Moreover, the various components
shown in FIG. 11 can be implemented in hardware, a processor
executing software instructions, or a combination of both hardware
and a processor executing software instructions, including one or
more signal processing and/or application specific integrated
circuits.
[0058] Throughout this specification, plural instances may
implement components, operations, or structures described as a
single instance. Although individual operations of one or more
methods are illustrated and described as separate operations, one
or more of the individual operations may be performed concurrently,
and nothing requires that the operations be performed in the order
illustrated. Structures and functionality presented as separate
components in example configurations may be implemented as a
combined structure or component. Similarly, structures and
functionality presented as a single component may be implemented as
separate components. These and other variations, modifications,
additions, and improvements fall within the scope of the subject
matter herein.
[0059] Additionally, certain embodiments are described herein as
including logic or a number of routines, subroutines, applications,
or instructions. These may constitute either software (e.g., code
embodied on a machine-readable medium or in a transmission signal)
or hardware. In hardware, the routines, etc., are tangible units
capable of performing certain operations and may be configured or
arranged in a certain manner. In example embodiments, one or more
computer systems (e.g., a standalone, client or server computer
system) or one or more hardware modules of a computer system (e.g.,
a processor or a group of processors) may be configured by software
(e.g., an application or application portion) as a hardware module
that operates to perform certain operations as described
herein.
[0060] In various embodiments, a hardware module may be implemented
mechanically or electronically. For example, a hardware module may
comprise dedicated circuitry or logic that is permanently
configured (e.g., as a special-purpose processor, such as a field
programmable gate array (FPGA) or an application-specific
integrated circuit (ASIC)) to perform certain operations. A
hardware module may also comprise programmable logic or circuitry
(e.g., as encompassed within a general-purpose processor or other
programmable processor) that is temporarily configured by software
to perform certain operations. It will be appreciated that the
decision to implement a hardware module mechanically, in dedicated
and permanently configured circuitry, or in temporarily configured
circuitry (e.g., configured by software) may be driven by cost and
time considerations.
[0061] As used herein any reference to "one embodiment" or "an
embodiment" means that a particular element, feature, structure, or
characteristic described in connection with the embodiment is
included in at least one embodiment. The appearances of the phrase
"in one embodiment" in various places in the specification are not
necessarily all referring to the same embodiment.
[0062] Some embodiments may be described using the expression
"coupled" and "connected" along with their derivatives. For
example, some embodiments may be described using the term "coupled"
to indicate that two or more elements are in direct physical or
electrical contact. The term "coupled," however, may also mean that
two or more elements are not in direct contact with each other, but
yet still co-operate or interact with each other. The embodiments
are not limited in this context.
[0063] As used herein, the terms "comprises," "comprising,"
"includes," "including," "has," "having" or any other variation
thereof, are intended to cover a non-exclusive inclusion. For
example, a process, method, article, or apparatus that comprises a
list of elements is not necessarily limited to only those elements
but may include other elements not expressly listed or inherent to
such process, method, article, or apparatus. Further, unless
expressly stated to the contrary, "or" refers to an inclusive or
and not to an exclusive or. For example, a condition A or B is
satisfied by any one of the following: A is true (or present) and B
is false (or not present), A is false (or not present) and B is
true (or present), and both A and B are true (or present).
[0064] In addition, use of the "a" or "an" are employed to describe
elements and components of the embodiments herein. This is done
merely for convenience and to give a general sense of the
description. This description, and the claims that follow, should
be read to include one or at least one and the singular also
includes the plural unless it is obvious that it is meant
otherwise.
[0065] While the present invention has been described with
reference to specific examples, which are intended to be
illustrative only and not to be limiting of the invention, it will
be apparent to those of ordinary skill in the art that changes,
additions and/or deletions may be made to the disclosed embodiments
without departing from the spirit and scope of the invention.
[0066] The foregoing description is given for clearness of
understanding; and no unnecessary limitations should be understood
therefrom, as modifications within the scope of the invention may
be apparent to those having ordinary skill in the art.
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