FLUID SENSOR MODULE
20220291165 · 2022-09-15
Inventors
Cpc classification
A61M1/1605
HUMAN NECESSITIES
A61M1/1619
HUMAN NECESSITIES
G01N27/4163
PHYSICS
A61M1/3609
HUMAN NECESSITIES
A61M1/367
HUMAN NECESSITIES
International classification
Abstract
A fluid sensor device can include a housing having an inlet and an outlet. The housing can have a fluid reservoir, a sensing assembly, a plunger, a valve, and a plurality of channels. The fluid sensor module can be used to sense constituents in a sample fluid (e.g. patient's blood or dialysate) during a treatment process, such as kidney dialysis procedures. The fluid sensor module can be connected in-line to a medical device to sense the sample fluid.
Claims
1. A fluid sensor module comprising: a sensing assembly; a fluid pathway configured to transfer a sample fluid to be in fluid communication with the sensing assembly; and a valve movable between a sensing position in which the sample fluid is transferred along the fluid pathway and a calibration position in which a calibration fluid is transferred from a calibration fluid reservoir along the fluid pathway.
2. The fluid sensor module of claim 1, further comprising a housing, the sensing assembly coupled to or formed with the housing.
3. The fluid sensor module of claim 2, further comprising a fluid inlet to transfer the sample fluid into the housing and a fluid outlet to transfer the sample fluid out of the housing, wherein when the valve is in the sensing position, the sample fluid is conveyed from the fluid inlet, along the fluid pathway, and through the outlet.
4. The fluid sensor module of claim 3, wherein when the valve is in the calibration position, the calibration fluid is conveyed from the calibration fluid reservoir, along the fluid pathway, and through the outlet.
5. The fluid sensor module of claim 4, wherein when the valve is in the calibration position, the sample fluid is conveyed from the fluid inlet to the fluid outlet so as to bypass the fluid pathway.
6. The fluid sensor module of claim 3, wherein the valve has a bypass position in which the fluid inlet is directly connected to the fluid outlet such that the sample fluid is conveyed from the fluid inlet to the fluid outlet so as to bypass the fluid pathway, the valve in the bypass position blocking the calibration fluid from entering the fluid pathway.
7. The fluid sensor module of claim 3, wherein the valve has a fill position in which the fluid inlet is directly connected to the calibration fluid reservoir to transfer the calibration fluid from an external source to the calibration fluid reservoir.
8. The fluid sensor module of claim 3, wherein when the valve is in the sensing position, a portion of the sample fluid flows directly between the fluid inlet and the fluid outlet so as to bypass the fluid pathway.
9. The fluid sensor module of claim 3, wherein when the valve is in the sensing position, an entirety of the sample fluid flows along the fluid pathway such that substantially no portion of the sample fluid bypasses the fluid pathway.
10. The fluid sensor module of claim 2, further comprising a plunger coupled to the housing in the calibration fluid reservoir, the plunger movable to drive the calibration fluid along a calibration fluid pathway to the valve.
11-12. (canceled)
13. The fluid sensor module of claim 1, wherein the sensing assembly comprises a functionalized electrode configured to, in response to interacting with the sample fluid, transmit a signal indicative of a constituent component of the sample fluid.
14-15. (canceled)
16. The fluid sensor module of claim 1; further comprising a reader, the fluid sensor module configured to electrically and mechanically connect to the reader.
17-37. (canceled)
38. A multi-port fluid valve for a fluid sensor module, the valve comprising: a valve body configured to be in operable communication with a first inlet channel through which a sample fluid enters the fluid sensor module, a second outlet channel through which fluid exits the fluid sensor module, a third calibration channel through which a calibration fluid flows, a fourth sample entry channel to transfer the sample fluid to be in fluid communication with a sensing assembly, and a fifth sample exit channel to transfer the sample fluid away from the sensing assembly, wherein the valve has a sensing mode in which the first inlet channel and the fourth sample entry channel are connected, the fifth sample exit channel and the second outlet channel are connected, and the third calibration channel is closed, and wherein the valve has a calibration mode in which the first inlet channel and the second outlet channel are connected, the third calibration channel and the fourth sample entry channel are connected, and the fifth sample exit channel and the second outlet channel are connected.
39. The valve of claim 38, wherein, in the sensing mode, the first inlet channel and the second outlet channel are partially connected to provide a regulated flow rate therebetween.
40. The valve of claim 38, wherein the valve has a bypass mode in which the first inlet channel and the second outlet channel are connected, and in which the third calibration channel, the fourth sample entry channel, and the fifth sample exit channel are closed.
41. The valve of claim 38, wherein the valve has a filling mode in which the first inlet channel is connected to the third calibration channel, and in which the second outlet channel, the fourth sample entry channel, and the fifth sample exit channel are closed.
42. The valve of claim 41, wherein the valve body comprises a through recess formed vertically through a head of the valve body, the through recess extending circumferentially along the valve body at a first angle; an upper partial recess formed partially through the head of the valve body, the upper partial recess extending circumferentially along the valve body at a second angle; a first lower partial recess formed partially through the head of the valve body, the first lower partial recess extending circumferentially along the valve body at a third angle; and a second lower partial recess formed partially through the head of the valve body, the second lower partial recess extending circumferentially along the valve body at a fourth angle.
43-71. (canceled)
72. A method of sensing fluid comprising: rotating a valve body to switch between a plurality of operating modes, the plurality of operating modes comprising a sensing mode and a calibration mode, sensing one or more constituent component of a sample fluid in the sensing mode using one or more functionalized electrodes, and calibrating the one or more functionalized electrodes by driving a calibration fluid over the one or more functionalized electrodes in the calibration mode.
73. The method of sensing fluid of claim 72, further comprising: rotating the valve body to switch to a bypass mode, and directing the sample fluid to be conveyed from a fluid inlet to a fluid outlet, bypassing the fluid pathway.
74. The method of sensing fluid of claim 72, further comprising: rotating the valve body to switch to a filling mode, and driving the calibration fluid through the fluid inlet and to a calibration fluid reservoir.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0025]
[0026]
[0027]
[0028]
[0029]
[0030]
[0031]
[0032]
[0033]
[0034]
[0035]
[0036]
[0037]
[0038]
[0039]
[0040]
[0041]
[0042]
[0043]
[0044]
[0045]
[0046]
[0047]
[0048]
[0049]
[0050]
[0051]
[0052]
[0053]
[0054]
[0055]
[0056]
[0057]
[0058]
[0059]
[0060]
[0061]
DETAILED DESCRIPTION
[0062] Various embodiments relate herein to a fluid sensor module configured to connected in-line to a medical device, such as a dialysis treatment system. For example, in kidney hemodialysis systems, blood can be transferred from the patient, through the dialysis treatment system, and back into the patient, to treat the patient's blood. In a peritoneal dialysis (PD) system, the treatment system can pump dialysate in a circulation through the abdominal cavity. During a treatment procedure, it can be important to monitor the composition of constituent materials in a sample fluid such as a treatment fluid (e.g., dialysate) and/or the patient's blood, such as creatinine, potassium, sodium, or any other constituent material that should be monitored. The fluid sensor module can be placed upstream or downstream of the treatment system to monitor the constituent materials.
[0063] Beneficially, the fluid sensor module can be sized and configured to be used at home by the patient, or in a clinical setting such as a hospital or clinic. For example, the fluid inlet and outlet can connect to the treatment system by way of a quick connection such as a luer lock or other fluid coupling. The fluid sensor module can mechanically and electrically connect to a reader which can both control the operation of the fluid sensor module and receive and transmit sensing information from the fluid sensor module.
[0064] The sensor module can comprise a sensing assembly including a plurality of functionalized electrodes (e.g., twelve electrodes in the illustrated embodiment) that, when exposed to the sample fluid, transmit a signal indicative of a particular constituent component of the sample fluid. A fluid pathway can extend and circulate over the functionalized electrodes to expose the functionalized electrodes to the sample fluid. As shown, the fluid pathway can comprise a curved pathway formed in the housing to convey the sample fluid (and calibration fluid) over the electrodes. The electrodes can electrically connect to corresponding I/O pads.
[0065]
[0066]
[0067]
[0068]
[0069] During a treatment procedure, the fluid sensor module can operate in a plurality of modes. As shown in
[0070] For example, in a bypass mode 510, the valve 102 can be placed in the bypass position 501. A valve motor disposed in a reader can connect to the valve 102 of the fluid sensor module 100 by way of a valve connector (e.g., a valve opening) configured to operably connect to a motor shaft of the valve motor. Processing electronics in the reader can be configured to send instructions to the valve motor to place the fluid sensor module in the bypass mode 510 by, e.g., rotating the valve 102 to the bypass position 501. In the bypass position 501, the channels 1 and 2 can be connected to each other allowing a fluid to flow through while the channels 3, 4, 5 are blocked by the valve head 120 (see
[0071] During a calibration mode 520, the valve motor can place the valve 102 in the calibration position 502 as shown in
[0072] During the calibration mode 520, processing electronics of a reader connected to a fluid sensor module can send instructions to a plunger motor of the reader. The plunger motor can rotate the plunger 108 of the fluid sensor module 100 by a specified amount to drive a predetermined volume of the calibration fluid from the reservoir 105, through the calibration channel 135, and into the fluid pathway 130 to purge the electrodes of the sensing assembly 104 of sample fluid and any other materials as shown in
[0073] During a sensing mode 530, the valve motor of the reader can rotate the valve 102 of a fluid sensor module 100 to the sensing position 503 as shown in
[0074] The processing electronics of the reader can be programmed to automatically switch between various modes of the fluid sensor module. For example, the process electronics can be programmed to automatically cycle between the sensing mode (in which the constituent component(s) of the sample fluid are monitored) and the calibration mode (in which the calibration fluid flushes the sensing assembly). In some embodiments, the processing electronics can be further configured to automatically switch into the bypass mode when the sensing device is to be inactive. In some embodiments, the user (e.g., patient or clinician) can manually switch modes by engaging a user interface (UI) of the reader. The UI of the reader can comprise a touch screen and/or buttons that enable the user and/or clinician to interact with the reader. In some embodiments, the UI can include a display that indicates the levels of the constituent fluids.
[0075] In addition, the sensor module can include a fill mode 540 by rotating the valve 102 to a fill position 504. In the fill mode 540, the calibration fluid 52 can be pumped or otherwise driven into the fluid inlet 106. In some embodiments, as shown in
[0076]
[0077]
[0078]
[0079] Beneficially, the fluid system disclosed herein can enable the patient to conduct medical treatments (such as dialysis) at home, or otherwise outside of a clinical setting. As one example, when the patient goes to bed for the night, the patient can initiate the dialysis system, and connect the fluid sensor module to the reader. The fluid inlet and fluid outlet of the fluid sensor module can fluidly connect to the treatment system of the medical device, for example, by way of a luer lock or other fluid coupler. The dialysis (or other) machine can be activated, and the sensor module can automatically cycle between bypass mode, calibration mode, and sensing mode (in any suitable order). If an anomaly is detected during the sensing mode, the reader can transmit an alarm to the clinician and/or otherwise modify the treatment procedure automatically. Once the treatment procedure is completed, the patient can disengage the treatment system, and remove the fluid sensor module. The fluid sensor module can be disposed and, for the next treatment procedure, a new fluid sensor module can be inserted into the reader and connected to the medical device.
[0080] Although the devices and methods were described to be used with medical treatment and in medical settings, it is to be appreciated that the procedures and devices disclosed herein may be performed on or applied to any kinds of sample or fluid to be tested or sensed with sensors.
[0081] Unless the context clearly requires otherwise, throughout the description and the claims, the words “comprise,” “comprising,” “include,” “including” and the like are to be construed in an inclusive sense, as opposed to an exclusive or exhaustive sense; that is to say, in the sense of “including, but not limited to.” The word “coupled”, as generally used herein, refers to two or more elements that may be either directly connected, or connected by way of one or more intermediate elements. Likewise, the word “connected”, as generally used herein, refers to two or more elements that may be either directly connected, or connected by way of one or more intermediate elements. Additionally, the words “herein,” “above,” “below,” and words of similar import, when used in this application, shall refer to this application as a whole and not to any particular portions of this application. Moreover, as used herein, when a first element is described as being “on” or “over” a second element, the first element may be directly on or over the second element, such that the first and second elements directly contact, or the first element may be indirectly on or over the second element such that one or more elements intervene between the first and second elements. Where the context permits, words in the above Detailed Description using the singular or plural number may also include the plural or singular number respectively. The word “or” in reference to a list of two or more items, that word covers all of the following interpretations of the word: any of the items in the list, all of the items in the list, and any combination of the items in the list.
[0082] Moreover, conditional language used herein, such as, among others, “can,” “could,” “might,” “may,” “e.g.,” “for example,” “such as” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and/or states. Thus, such conditional language is not generally intended to imply that features, elements and/or states are in any way required for one or more embodiments.
[0083] While certain embodiments have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of the disclosure. Indeed, the novel apparatus, methods, and systems described herein may be embodied in a variety of other forms; furthermore, various omissions, substitutions and changes in the form of the methods and systems described herein may be made without departing from the spirit of the disclosure. For example, while blocks are presented in a given arrangement, alternative embodiments may perform similar functionalities with different components and/or circuit topologies, and some blocks may be deleted, moved, added, subdivided, combined, and/or modified. Each of these blocks may be implemented in a variety of different ways. Any suitable combination of the elements and acts of the various embodiments described above can be combined to provide further embodiments. The accompanying claims and their equivalents are intended to cover such forms or modifications as would fall within the scope and spirit of the disclosure.