AU2016204226B2

AU2016204226B2 - Sensor apparatus systems, devices and methods

Info

Publication number: AU2016204226B2
Application number: AU2016204226A
Authority: AU
Inventors: Arun D. Chawan; Jason A. Demers; Kevin L. Grant; Dean Kamen; N. Christopher Perry; Brian Tracey
Original assignee: Deka Products LP
Current assignee: Deka Products LP
Priority date: 2007-02-27
Filing date: 2016-06-22
Publication date: 2017-08-24
Anticipated expiration: 2028-02-27
Also published as: AU2020202330A1; AU2017253581B2; AU2021221875B2; AU2016204226A1; AU2020202330B2; AU2017253581A1; AU2021221875A1

Abstract

SENSOR APPARATUS SYSTEMS, DEVICES AND METHODS A sensor manifold for use in a hemodialysis system including a plurality of fluid paths, each fluid path including at least one sensing probe, the sensing probe configured to detect a temperature or conductivity of a fluid in the fluid path, wherein one sensing probe is configured to detect temperature of the fluid and two sensing probes are configured to detect conductivity of the fluid.

Description

Regulation 3.2 2016204226 22 Jun2016

AUSTRALIA

Patents Act 1990

COMPLETE SPECIFICATION DIVISIONAL APPLICATION APPLICANT: DEKA Products Limited Partnership

Invention Title: SENSOR APPARATUS SYSTEMS, DEVICES AND

METHODS

The following statement is a full description of this invention, including the best method of performing it known to me: 2016204226 22 Jun2016

SENSOR APPARATUS SYSTEMS, DEVICES AND METHODS

Cross-Reference to Related Applications

This application is a continuation-in-part of Patent Application Serial No. : 11/871,821, filed October 12,2007 and entitled Sensor Apparatus Systems, Devices and 5 Methods, which application claims priority from the following United States Provisional Patent Applications, all of which are hereby incorporated herein by reference in their entireties: U.S. Provisional Patent Application No. 60/904,024 entitled Hemodialysis System and Methods filed on February' 27, 2007; and 10 U.S. Provisional Patent Application. No. 60/921.,314 entitled Sensor Apparatus filed on April 2, 2007.

This application is also related to the following United States Patent Applications, and are hereby incorporated herein by reference in their entireties: U.S. Patent Application Serial No. 11/871,712, filed October 12,2007 entitled 15 Pumping Cassette (Attorney Docket No. DEKA-020XX); U.S. Patent Application Serial No. 11/871,787, filed October 12, 2007 and entitled Pumping Cassette ( Attorney Docket No. DEKA-021XX); U.S. Patent Application Serial No. 1.1/87.1,793, filed October 12,2007 and entitled Pumping Cassette (Attorney Docket No. DEKA-022XX); U.S. Patent Application Serial No, 11/871,803, filed October 12,2007 and entitled Cassette System 20 Integrated Apparatus (Attorney Docket No. DEKA-023XX); and U.S. Patent Application Serial No. 11/871,828, filed October 12,2007 and entitled Peritoneal Dialysis Sensor Apparatus, Systems, Devices and Methods (Attorney Docket; F30 (previously DEKA-025 XX».

Further, this application is related to the following United States Patent 25 Applications, which are being filed on even date herewith and are hereby incorporated herein by reference in their entireties: U.S. Patent Application entitled Cassette System Integrated Apparatus (Attorney Docket No. F62); and U.S. Patent Application entitled Hemodialysis System and Methods ( Attorney Docket No. D0570/70019US00).

Technical Field 2016204226 22 Jun2016

The present invention relates to sensor systems, devices, and methods, and more particularly to systems, devices, and methods for sensors, sensor apparatus, and sensor apparatus systems. 5 Background Art

In many applications, the temperature of a media, whether a solid, liquid or gas, is determined. One method is introducing a temperature sensor apparatus or probe to the medium being measured. For accuracy, close proximity of the sensor to the subject media is desired. H owever , this me thod may lead to contamination of the sensor apparatus and/or 10 the fluid. Additional problems with harsh media or problems with the accuracy of the device used exist.

The concentration of a known compound in a media, whether fluid or otherwise, can be determined through measuring the conducti vity of the fluid. Determining the conductivity of a material can also provide useful information such as the composition or 15 presence of a particular compound in a material or irregularities in the conductive material between conductivity sensing probes. The presence, absence or variation of conductivity can also be a useful determinant of anomalies in a system.

There is a need for an apparatus that can both sense the temperature and the conductivity of a fluid or other media. There is a desire for a combination temperature and 20 conductivity sensor that avoid contamination with the subject media and is compact. Also, there is a desire for an accurate temperature sensing device.

Additionally, there is a need for an accurate measurement apparatus to measure the temperature, conductivity', and/or other condition of a subject media while avoiding contamination between with tire measurement apparatus and the subject media. There is 25 also a need for an accurate measurement apparatus that can measure the temperature, conductivity, and/or other condition of a subject media where such subject media is contained in and/or flowing through a disposable component such that part or all of the sensor apparatus can be reused and need not be disposed of along with the disposable component. >

Summary of the invention 2016204226 22 Jun2016

In accordance with one aspect of the invention there is provided a sensor apparatus system for determining one or more properties of a subject fluid in a cassette, the system comprising a probe housing; a thermal sensor in said probe housing having a sensing end 5 and a connector end; a probe tip thermally coupled to said sensing end of the thermal sensor and attached to said probe housing, the probe tip adapted for thermal coupling with an inner surface of a well installed in a cassette; and at least two leads connected to said connector end of said thermal sensor, whereby thermal energy is transferred from said well to said thermal sensor and whereby temperature information is conveyed through said leads, in 10 various alternative embodiments, the sensing probe may further include a third lead attached to one of the probe housing, the thermal sensor, and the probe tip for permi tting conductivity sensing. Alternatively, the sensing probe may further include a conductivity sensor attached to one of the probe housing, the thermal sensor, and the probe tip for permitting conductivity sensing; and a third lead attached to the conductivity sensor for 15 transmitting conductivity information. A urethane resin may be included between said probe tip and said probe housing. The probe tip may include a flange for mating with the housing. in various alternative embodiments of the sensor apparatus system described above, thermal epoxy may be included between said thermal sensor and said probe tip. The probe tip may be copper, steel, or a metal including at least one of silver, copper, steel, and 20 stainless steel In various embodiments, the housing may be plastic or metal The housing may include a flange disposed about said probe housing, and a spring may be used in conjunction with the flange. The housing may include an integrated flexible member.

Some embodi ments of this aspec t of the present invention include a wel l of a predetermined size and shape. The well mates with the probe and the probe tip is thermal 25 coupled to said well

In accordance with one aspect of the present invention the well includes a hollow housing of a thermally conductive material. The housing has an outer surface and au inner surface. The inner surface is a predetermined shape so as to form a mating relationship with a sensing probe. The mating thermally couples the inner surface with a sensing probe. 30 Some embodiments of this aspect of the present invention include a predetermined volume of thermal grease on the inner surface of the well

In accordance with, one aspect of the present invention, method for determining temperature and conductivity of a subject media in a cassette is described. The method 3 includes the following steps: installing at least one well in a cassette; thermally coupling a well and a sensing probe such that temperature and conductivity can be determined; transferring thermal and conductivity signals through at. least 3 leads from the sensing probe; and determining temperature and conductivity using the signals. 2016204226 22 Jun2016 5 In accordance with another aspect of the present invention, a method for detecting air in a fluid line contained in a cassette is described. The method includes the following steps: installing at least one well in a cassette; thermally coupling at least two wells located in a fluid line to sensing probes such that temperature and conductivity can be determined; transferring conductivity signals through at least 3 leads from the sensing probes; t o determining conducti vity for each sensing probe; calculating the difference of conducti vity front each sensing probe; and determining if the difference exceeds a threshold.

In accordance with another aspect of the invention there is provided apparatus comprising a fluid conduit in a cassette including a w!eil for at least one of transmitting temperature and permitting conductivity sensing of fluid passing through the conduit, 15 wherein the well is adapted for interconnection with a sensor. in various alternative embodiments, die apparatus may be configured so that a portion of the well comes into contact with fluid in the conduit or so that no portion of the well comes into contact with fluid in the conduit. The fluid conduit in die cassette may include plastic tubing or metal tubing, 20 in various embodiments, the cassette containing the fluid line comprises a rigid body overlaid on one or more sides with a flexible diaphragm. In various embodiments the flexible diaphragm cassette includes one or more pump chambers and/or one or more value stations. In various embodiments, one or more wells are positioned on the edge of the cassette. In certain of these embodiments, one or more wells are positioned on the bottom 25 edge of the cassette. in various embodiments, the cassette has a rigid front and/or back plate. One or more wells may be installed in the rigid cassette. Alternatively, one or more sensor leads may be installed in the rigid cassette. In various embodiments, the rigid cassette may contain one or more pod pumps. 30 The cassette and the well may be integrally formed from the same material.

Alternatively, the well may be coupled to the cassette, e.g., using at least one of press fit connection, flexible tabs, adhesive, ultrasonic weld, and a retaining plate and fastener. An ο-ring may be disposed between the 'well and the fluid conduit. The o-ring may include one of a round cross-section, a square cross-section, and an X-shaped cross- 4 section. The well may include a groove to receive a portion of the o-ring. A portion of the well in contact with the conduit may be flexible so as to deform the conduit and may include a plurality of cuts to provide such flexibility. 2016204226 22 Jun2016 in accordance with another aspect of the invention there is provided a fluid 5 pumping apparatus comprising at least one pump and a well for at least one of transmitting temperature and permitting conductivity sensing of fluid passing through the conduit, wherein the well is adapted for interconnection with a sensor, in various alternative embodiments, the at least one pump may include at least one pod pump and may include a pair of pod pumps. The at least one pump and the well may be in tegrated into a cassette, to In accordance with another aspect of the invention there is provided a sensing system comprising at least one sensing probe and at least one well installed in a cassette, the well in communicati on with the sensing probe for at least one of thermal sensing and conductivity sensing.

In accordance with another aspect of the invention there is provided a sensor 15 manifold comprising a cassette and at least one sensing probe for at least one of thermal sensing and conductivity sensing. In various embodiments, the sensor manifold contains two or more fluid paths and two or more sensing probes for at least one of thermal sensing and conductivity sensing. In various embodiments, the sensor manifold is passive with, respect to controlling the flow of the fluid in the fluid paths within the cassette, in such 20 embodiments, the sensor manifold may be free from valves and pumping mechanisms, in various embodiments, the sensor manifold may comprise a cassette with a rigid front and/or back plate and a mid-plate. In various embodiments, the sensor manifold may comprise electrical circuits connected to the sensing probes. In certain of these embodiments, the sensor manifold may comprise a printed circuit board. 25 These aspects of the invention are not meant to be exclusive or comprehensi ve and other features, aspects, and advantages of the present invention are possible and will be readily apparent to those of ordinary skill in the art when read in conjunction with the following description, the appended claims, and the accompanying drawings.

Brief Description of the Drawings 30 T he foregoing features of the invention wil l be more readily understood bv reference to the following detailed description, taken with reference to the accompanying drawings, wherein: 5 FIG, i A mid IB are embodiments of the sensing apparatus where the thermal well is a continuous part of the fl uid line; 2016204226 22 Jun2016 FIG. 2 A and 2B are embodiments of the sensing apparatus where the thermal well is a separate part from the fluid line; 5 FIG, 3A and 3B are embodiments of the sensing apparatus showing various lengths and widths of the thermal well; FIG. 4 is a pictorial view of a thermal well according to one embodiment of the sensing apparatus; FIG. 5 is a cross sectional view of an exemplary embodiment of the thermal well; JO FIGS. 6 A and 68 show section views of embodiments of thermal wells having variable wall thickness; FIGS. 7A-7S are sectional views of various embodiments of the thermal well embedded in a fluid line; FIG. 8 is a section side view of one embodiment of the sensing probe; J 5 FIG. 9 is an exploded view of the embodiment shown in FIG. 8; FIG. 10 is a sectional view of an alternate embodiment of the tip of the sensing probe; FIG. 11A is an alternate embodiment of the sensing probe; FIG, 11B is an alternate embodiment of the sensing probe; 20 FIG. 12 is a side view of an alternate embodiment of the sensing probe; FIG. 13 A is a section view of a sensing probe coupled to a thermal well; FIG. 13B Is an alternate embodiment of the sensing probe shown in FIG. 13 A; FIG, I4A is a section view of a sensing probe as shown in FIG, 8 coupled to a thermal well; 25 FIG. 14B is an alternate embodiment of the sensing probe shown in FIG. 1,4A; FIG. 15 is a sectional view of one exemplary embodiment of the sensor apparatus; FIG. 16 shows an alternate embodiment of a sensing probe coupled to a thermal well; FIG. 17 is a section view of one embodiment of a sensing probe coupled to a 30 thermal well and suspended by a spring; FIG. 18 is a section view of one embodiment of a sensing probe in a housing; FIG. 19 is a section view of one embodiment of a sensing probe in a housing: FIG. 20 is a section view of one embodiment of a sensing probe in a housing; FIG. 21 is a side view of a fluid line including two sensors; 6 FIG. 22 is a section view of a fluid line with, a sensor apparatus; 2016204226 22 Jun2016 FIG. 23 A is a section v iew of the back side of an exemplary cassette; FIG. 23B is a side view of the side of an exemplary cassette;

FiG. 23C is a section view of the front of an exemplary cassette; 5 FIG, 24 is a view of an exemplary cassette and thermal wells; FIG. 25 is a view of an exemplary cassette with thermal wells installed; FIG. 26 is a view of the thermal wells extending into a fluid line of an exemplar cassette; FIG. 27 is a close up certain features of FIG. 26; 10 FIG . 28 is a section view' of one embodiment of a sensing probe coupled to a thermal well installed in a cassette and suspended by a spring; FIG. 29 is a sectional view of one embodiment of a pod-pump that is incorporated into embodiments of cassette; FIGS. 30A are front and isometric views of the exemplary' embodiment of the fluid 15 side of the midplate of the cassette; FIGS. 30B are front and isometric views of the exemplary embodiment of the air si de of the midpla te of the cassette; FIGS. 31A are front and isometric views of the exemplary embodiment of the inner side of the bottom plate of the cassette; 20 FIGS, 3 LB are front and isometri c views of the exemplary embodiment of the outer side of the bottom plate of the cassette ; FIG. 31C is a side view of the exemplary' embodiment of the midplate plate of the cassette; FIG. 32A is a top view of the assembled exemplary embodiment of the cassette; 25 FIG. 32B is a bottom view' of the assembled exemplary1 embodiment of the cassette; FIG. 32C is an exploded view' of the assembled exemplary embodiment of the cassette; FIG. 32D is an exploded view' of the assembled exemplary' embodiment of the cassette; 30 FIGS, 33A-33C show cross sectional views of the exemplary embodiment of the assembled cassette FIG, 34 is a perspective view of a system having a base unit with a disposable unit containing a manifold according to one embodiment of the invention; FIG. 35 is a perspective view of the disposable unit containing a manifold shown, in FIG. 34; 2016204226 22 Jun2016 FIG. 36A is a perspective view of the components from the system of FIG. 34: FIG. 36B is a perspective, back-side cross-sectional view of the manifold of FIGS. 5 35 and 38A-B, in accordance with an exemplary embodiment of the present invention; FIG. 36C shows a thermal well that may be used in the manifold of FIGS. 2.49, and I3B in the heat-exchanger figure of FIG. I, in accordance with an exemplary embodiment of the present invention; FIG. 37 shows a view of the manifold interface, in accordance with an exemplary' 10 embodiment of the present invention; FIGS. 38A and 38B respectively show a perspective back-side view and a perspective bottom view' of the manifold from FIG. 35, in accordance with an exemplary embodiment of the present inve ntion ; FIG. 39 is a view' of an exemplary sensor manifold; and 15 FIG. 40 is a view of another exemplary sensor manifold. FIG. 41 is a view of another exemplary sensor manifold. FIG. 42 is a view of the fluid paths within the exemplary' sensor manifold shown in FIG. 41. FIG. 43 is a side view of the exemplary' sensor manifold shown in FIG. 41, 20 FIG. 44A is a cross sectional view of the exemplary sensor manifold shown in FIG. 41 at cross section A-A of FIG. 448. FIG. 44B is a front view of the exemplary' sensor manifold shown m FIG. 41. FIG. 45 is an exploded view of the exemplary' sensor manifold shown in FIG. 41,

FIG. 46 is a view of a printed circuit board and media edge connector in accordance 25 w'ith the exemplary sensor manifold shown in FIG. 4L FIG. 47 is an exemplary fluid schematic of a hemodialysis system.

It should be noted that the foregoing figures and the elements depicted therein are not necessarily drawn to consistent scale or to any scale. Unless the context otherwise suggests, like elements are indicated by like numerals. 30 Detailed Description of Specific Embodiments

Definitions. As used in this description and the accompanying claims, the following terms shall have the meanings indicated, unless the context otherwise requires: s “Spheroid” means any three-dimensional shape that generally corresponds to a o val rotated about one of its principal axes, major or minor, and incl udes three-dimensional egg shapes, oblate and prolate spheroids, spheres, and substantially equivalent shapes. 2016204226 22 Jun2016 ‘idemispherokf' means any three-dimensional shape that generally corresponds to 5 approximately half a spheroid. “Spherical” means generally spherical. “Hemispherical” means generally hemispherical. “Fluid” shall mean a substance, a liquid for example, that is capable of being pumped through a flow line. Blood is a specific example of a fluid. 10 A “patient” includes a person or animal from whom, or to whom, fluid is pumped, whether as part of a medical treatment or otherwise. “Subject media”' is any material, including any fluid, solid, liquid or gas, that is in contact directly with a sensing probe or indirectly via thermal wells, sensor extension pins, and other such devices for transferring information regarding one or more characteristics of 15 such subject media to one or more sensors.

Various aspects of the present invention are described below with reference to various exemplary embodiments. It should be noted that headings are included for convenience and do not limit the present invention in any way.

Various embodiments of sensors, including thermal and/or c onductivity sensors, 2d are described. Such ther mal/conducti vity sensors can be used in a wide variety of applications and are by no means limited to tliermai/conductivity measurements of fluids or to tliermai/conductivity .measurements in any particular context. Additionally, various embodiments of systems, devices, and methods for sensor interface, including direct sensor contact, sensor interface through the use of a thermal well, or otherwise with various 25 disposable and reusable components are described. Such systems, devices, and methods for sensor interface can be used with a wide variety of sensors and in a wide variety of applications. Such systems, devices, and methods for sensor interface are by no means limited to use with the various sensor embodiments or for use in any particular context.

1. THERMAL WELLS 30 In one exemplary embodiment, a thermal well is used to accommodate a sensor probe, such as a temperature sensing probe. The thermal well comes into direct contact with a subject media (e.g., a liquid such as blood or dialysate) and the sensing probe does not. Based on heat transfer dictated in large part by the thermodynamic properties of the thermal well and sensing probe construction, the sensing probe can determine the properties 9 of the subject media without coming into direct contact with the subject media. The accuracy aid efficiency of the sensor apparatus arrangement depends on many factors including, but not limited to: construction, material and geometry of both the probe and the thermal well. 2016204226 22 Jun2016 5 Referri ng now to FIGS, 1A and 1B, two embodi ments of the sensor apparatus which includes the thermal well 5100 and the sensing probe 5102, are shown in relation to a fluid line 5108. In these embodiments, the thermal well 5100 is integrated into the fluid line 5108. However, in other embodiment, some described below, the thermal well 5100 is not completely integrated into the fluid line 5108, i.e., the thermal well 5100 can be made from 10 different materials as compared with the fluid line 5108. in alternate embodiments, the thermal well 5100 is not integrated into any fluid line but can be integrated into anything or nothing at all. For example, in some embodiments, the thermal well 5100 can be integrated into a container, chamber, machine, protective sleeve, fluid pump, pump cassette, disposable unit, manifold, or other assembly, sub-assembly , or component. For purposes of 15 the description, an exemplary embodiment is described for illustrative purposes. The exemplary embodiment includes the embodiment where the thermal well 5100 is in a fluid line. However, the sensor apparatus and the thermal well can be used outside of a fluid line.

Referring now to FIG. I A, a side view' showing a thermal well 5100 formed in a fluid line 5108 which provides the space 5104 for subject media to flow through, and a 20 sensing probe 5102 is shown , Data from the sensing probe is transmitted using at least one lead 5106. An end view' of FIG. 1A is shown in FIG. IB.

In this embodiment, the thermal well 5100 is one piece with the fluid line 5108. The total ar ea of the thermal well 5100 can vary. By varying the geometry of the thermal well 5100, the variables, including, but not limited to, the thermal conductivity 25 characteristic of the thermal well 5100 and thus, the heat transfer between the thermal well 5100 and the sensing probe 5102 will vary. As described in more detail below, the material construction of the thermal wel l 5100 is another variable in the sensor apparatus.

In some embodiments, the fluid line 5108 is made from a material having a desired thermal conductivity. This material may vary depending on the purpose. The material can 30 be anything including, but not limited to, any plastic, ceramic, metals or alloys of metals or combinations thereof.

Referring now to FIGS. 2A and 2B, in these embodiments, the fluid line 5108 and the thermal well 5100 are separate parts. In some embodiments, the fluid line 5108 and the thermal well 5100 are made from different materials. U) FIGS. 1A-1B and FIGS. 2A-2B show relatively simple embodiments of the sensor apparatus. Thus, for these embodiments, the sensing apparatus includes a thermal well 5100 and a sensing probe 5102 where the thermal well either is integrated as one continuous part with the fluid line 5108 or is a separate part from the fluid line 5108. However, many 5 embodiments of the sensor apparatus are contemplated. Much of the various embodiments include variations on the materials and the geometries of the thermal well 5100 and/or the sensing probe 5102. These variations are dictated by multiple variables related to the intended use for the sensor apparatus. Thus, the subject media and the constraints of the desired sensor, for example, tire accuracy, time for results and die fluid flow and subject t o media characteristics are but a sampling of the various constraints that dictate the 2016204226 22 Jun2016 embodiment used. In most instances, each of the variables will affect at least one part of the embodiment of the sensor apparatus.

Thus, multiple variables affect the various embodiments of the sensor apparatus, these variables include but are not limited to; 1) geometry of the thermal well; 2) material 15 composition of the thermal well; 3) material composition of the sensing probe; 4) desired flow rate of the subject media; 5) length and width of the thermal well; 6) desired accuracy of the sensing probe; 7) wall thicknesses; 8) length and width of the sensing probe; 9} cost of manufacture; 10) subject media composition and characteristics including tolerance tor turbulence; 11) geometry of sensing probe; and 12) desired speed of readings. 20 in the foregoing, various embodiments of the sensor apparatus are described. The description is intended to provide information on the affect the variables have on the sensor apparatus embodiment design. However, these are but exemplary embodiments. Many additional embodiments are contemplated and can be easily designed based on the intended use of the sensor apparatus. Thus, by changing one or more of the above mentioned partial 25 list of variables, the embodiment of the sensor apparatus may vary.

Referring now to FIGS. 3 A and 3B, two embodiments of the thermal well. 5100 are shown as different parts from the fluid line 5108. These embodiments show two geometries of the thermal well 5100. In FIG. 3A, the geometry includes a longer thermal well 5100. in FIG. 3B, the thermal well 5100 geometry is shorter. The length and width of 30 the thermal well 5100 produce varying properties and accuracies of the thermal conductivity between the thermal well 5100 and the sensing probe 5102. Depending on the use of the sensor apparatus, the thermal well 5100 geometry is one variable.

Referring now to FIG. 3A, the longer thermal well. 5100 generally provides a greater isolation between the subject media temperature in the fluid line 5104 and the a ambient temperature. Although the longer thermal well 5160 geometry shown in FIG, 3A may be more accurate., the embodiment shown in FIG. 3B may be accurate enough for the purpose at hand. Thus, the length and width of the thermal well 5100 can be any length and width having the desired or tolerable accuracy characteristics. It should be understood that 5 two extremes of length are shown in these embodiments; however, any length is 2016204226 22 Jun2016 contemplated. The description herein is meant to explain some of the effects of the variables.

Still referring to FIGS, 3A and 3B, the longer thermal well 5100 shown in FIG. 3A. may impact fee fluid flow of the subject media in the fluid Hue 5108 to a greater degree than 10 the embodiment shown i n FIG. 3B. It should be under stood that the length of the thermal well 5100 may also impact the turbulence of fee fluid flow. Thus, the length and width of the 'thermal well 5100 may be changed to have greater or lesser impact on the fluid flow and turbulence of the fluid, while mitigating the other variables.

The shape of the thermal well 5100 is also a variable. Any shape desired is 15 contemplated. However, fee shape of the thermal well 5100, as with the other variables, is determined in part based on the intended use of the sensor apparatus. For purposes of description, an exemplary embodiment is described herein. However, the shape in the exemplary embodiment is not meant to be limiting.

Referring now FIG. 4 for purposes of description, the thermal well 5100 has 20 been divided into 3 zones. The top zone 5402 communicates wife the sensing probe (not sho wn); the middle zone 5404 provides the desired length of the thermal well 5100. As described above, the length may dictate the level of protrusion into the fluid path.. The length is dictated in part by the desired performance characteristics as discussed above. The middle zone 5404 also isolates the top zone 5402 from the ambient. The middle zone 5404 25 may also serve to locate, fasten or seal the thermal well 5.1.00 into the fluid line (shown as 5108 in FIGS. 1A-1B).

The bottom zone 5406, which in some embodiments may not be necessary (see FIG. 7K) thus, in these embodiments, fee middle zone 5404 and the bottom zone 5406 may be a single zone. However, in the exemplary embodiment, fee bottom zone 5406 is shaped 30 to aid In press fitting the thermal well into an area in the fluid line and may locate and/or fasten the thermal well 5100 into the fluid line 5108. In other embodiments, zone 5406 may be formed to facilitate various joining methods (see FIGS. 7A-7J, 7L-7S)

Referring now to FIG. 5 a cross section of the exemplary' embodiment of the thermal well 5100 is shown. The dimensions of fee exemplary embodiment of fee thermal well 5100 include a length A of approximately .113 inches (with a range from 0-.379 inches), a radius B of approximately ,066 inches and a wal l thickness C ranging from approximately .003-.009 inches. These dimensions are given for purposes of an exemplary embodiment only. Depending on the variables and the intended use of the sensing 5 apparatus, the thermal well 5100 dimensions may vary, and the various embodiments are not necessarily proportional. 2016204226 22 Jun2016

In some embodiments, the wall thickness can be variable, i.e., the wail thickness varies in different locations of the thermal well. Although these embodiments are shown with variable thicknesses in various locations, this is for description purposes only. Various 10 embodiments of the thermal well may incorporate varying wall thickness in response to variables, these varying wall thicknesses can he “mixed and matched” depending on the desired properties of the sensing apparatus . Thus, for example, in some embodiments, a thinner zone 5404 may be used with thinner zone 5400 and vice-versa. Or, any other combination of “thinner” and “thicker” may be used. Also, the terms used to describe the 15 wall, thicknesses are relative. Any thickness desired is contemplated. The figures shown are therefore for descriptive purposes and represent two embodiments where many more are contemplated

Referring now to FIGS. 6A and 6B, zone 5402 can be thicker or thinner as desired. The thinner zone 5402, amongst other variables, generally provides for a faster 20 sensing time while a thicker zone may he useful for harsh environments or where sensor damping is desired. Zone 5404 may be thicker, amongst other variables, for greater strength or thinner for, amongst other variables, greater isolation from ambient. Zone 5406 can be thinner or thicker depending on the fastening method used.

The thermal well 5100, in practice, can be embedded into a fluid line 5108, as a 25 separate part from the fluid line 5108. This is shown and described above with, respect to FIGS. 2A-2B. Various embodiments may be used for embedding the thermal well 5100 into the fluid line 5108. Although the preferred embodiments are described here, any method or process for embedding a thermal well 5100 into a fluid line 5108 can be used. Referring now to FIGS. 7A-7S, various configurations for embedding the thermal well 5100 30 into the fluid line 5108 are shown. For these embodiments, the thermal well 5100 can be made from any materials, including but not limited to, plastic, metal, ceramic or a combination thereof. The material may depend in some part on the compatibility with the intended subject media. The fluid line 5108, in these embodiments, may be made from plastic, metal, or any other material that is compatible with the subject media.

Referring first to FIG. 7A, the thermal well 5100 is shown press fit into the fluid line 5108 using the zone 5404 (shown in FIG. 4). In FIG. 7B, the thermal well 5100 is shown press fit into the fluid line 5108 using the zone 5406. Referring now to FIG. 7C, the thermal well 5100 is shown retained in the fluid line 5108 with flexible tabs 5704, an 0~ring 5 is also provided Referring now to FIG. 7D, the thermal well 5100 is shown inserted into the fluid hue 5108 with an O-ring 5702. The thermal well 5100 is also shown as an alternate embodiment, where the thermal well 5100 zone 5406 includes an O-ring groove. The O-ring groove can be cut, formed, spun, cast or in jection molded into the thermal welt, or formed into the thermal well 5100 by any other method. FIG. 7E shows a similar 10 embodiment to that shown in FIG. ?D, however, the O-ring groove is formed in zone 5406 rather than cut, molded or cast as shown in FIG. 7D. 2016204226 22 Jun2016

Referring now to FIG. 7F, the thermal well 5100 is shown press fit into the fluid line 5108, zone 5406 includes flexibility allowing the edge of zone 5406 to deform the material of the fluid line 5108. Referring now' to FIG. 7G, the thermal well 5100 includes 15 cuts 5706 on the zone 5406 providing flexibility of the zone 5406 for assembly with the fluid line 5108. An O-ring 5702 is also provided. Although two cuts are shown, a greater number or fewer cuts are used in alternate embodiments.

Referring now to FIG. 7H, the embodiment shown in FIG. 7F is shown with the addition of an O-ring 5702. Referring to FIG . 71, the thermal well 5100 is shown insert 20 molded in the fluid line 5108. Zone 5406 is formed to facilitate or enable assembly by insert molding, FIG. 7J shows an embodiment where the thermal well 5.1.00 is heat staked 5708 to retain the thermal well 5100 in the fluid line 5108. In some embodiments of FIG. 7j, an O-ring 5710 is also included. In this embodiment, the O-ring 5710 has a rectangular cross 25 section. However, in alternate embodiments, the O-ring may have a round or X-shaped cross section. Likewise, in the various embodiments described herein having an O-ring, the O-ring in those embodiments can have a round, rectangular or X-shaped cross section, or any cross sectional shape desired.

Referring now to FIG. 7K, the thermal well 51.00 is retained in the fluid line 30 5108 by adhesive 5712, The adhesive can be any adhesive, but in one embodiment, the adhesive is a UV curing adhesive. In alternate embodiments, the adhesive may be any adhesive that is compatible with the subject media. In this embodiment, the thermal well 5100 is shown without a zone 5406. 14

Referring now to FIG. 7L, thermal well 5100 is shown ultrasonically «'elded in the fluid Sine 5108. The zone 5406 is fabricated to enable joining by ultrasonic welding. 2016204226 22 Jun2016

Referring now to FIG. 7M, a thermal well 5100 is shown insert molded in the fluid line 5.1.08. Zone 5406 is a flange for the plastic in the fluid line 5108 to flow around. 5 In the embodiment shown, the flange is flat., however, in other embodiments; the flange may be bell shaped or otherwise.

Referring now' to FIG. 7N, the thermal well 5100 is shown retained in the fluid line 5108 by a retaining plate 5714 and a fastener 5716. O-ring 5702 is also shown.

Referring now' to FIGS. 70-7P, an end view is shown of a thermal well 5100 to that is retained in a fluid line 5108 by a retaining ring 5718 (FIG. 70) or in an alternate embodiment, a clip 5720 (FIG. 7P), O-ring 5702 is also shown.

Referri ng now to FIG. 7Q, the embodiment of FIG. 7C is shown with an alternate embodiment of the thermal well 5100. In this embodiment of the thermal well 5100 the referred to as zone 5404 in FIG. 4 includes a taper that may allow for easier 15 alignment with a sensing probe, better isolation of zone 5402 from the ambien t and better flow characteristics in the fluid path. The thermal well 5100 is shown retained in the fluid Hue 5108 using flexible tabs 5704, An O-ring is also provided, FIG, 7R shows the embodiment of F IG 7J with an alternate embodiment of the thermal well 5100, The thermal well 5100 shown in this embodiment has a taper in zone 20 5404 that may allow for easier alignment with a sensing probe, may allow better isolation of zone 5402 from the ambient and may allow better flow characteristics in the fluid path.

Zone 5402 provides a hemispherical contact for effective thermal coupling with a thermal probe. The thermal well 5100 is heat staked 5708 to retain the thermal well 5100 in the fluid line 5108. In some embodiments of FIG. 7R, an O-ring 5710 is also included, in this 25 embodiment, the O-ring 5710 has a rectangular cross section. However, in alternate embodiments, the O-ring can have a round or X-shaped cross section.

Referring now' to FIG. 7S, the embodiment of FIG. 7H is shown with an. alternate embodiment of the thermal well 5100. FIG. 7S is shown with the addi tion of an O-ring 5702. In this embodiment of the thermal well 5100 zone 5404 (as shown in. FIG. 4) 30 has convolutions that may allow better isolation of zone 5402 from the ambient. While several geometries have been shown for zone 5404, many others could be shown to achieve desired performance characteristics.

2. SENSING PROBES 15

Various embodiments of systems, devices, and methods for sensor interface, including direct sensor contact, sensor interface through the use of a thermal wel l, or otherwise with, various disposable and reusable components are described. Such systems, 2016204226 22 Jun2016 devices, and methods for sensor interface can be used with a wide variety of sensors and in 5 a wide variety of applications. Such systems, devices, and methods for sensor interface are by no means limited to use with the various sensor embodiments or for use in any particular context.

Referring now to FIG. 8, a sectional v iew of an exemplary1' embodiment of a sensing probe 5800 is shown. The housing 5804 is a hollow structure that attaches to the tip to 5802. The tip is made of a highly thermally conductive material The housing 5804, in the exemplary embodiment, is made from a thermally insulative material in some embodiments, the housing is made of a thermally and electrically insulative material, in the exemplary embodiment, the housing 5804 is made of plastic which is a thermally insulative and electrically insulative material The tip 5802 either contacts the subject media directly, 15 or else is mated with a thermal well in the exemplary embodiment, the tip 5802 is attached to the housing 5804 using a urethane resin or another thermal insulator in between (area 5807) the tip 5802 and the housing 5804. Urethane resin additionally adds structural support. In alternate embodiments, other fabrication and joining methods can be used to join the tip 5802 to the 20 housing 5804.

The tip 5802 of the sensing probe 5800 is made of a thermally conducti ve material The better thermally conductive materials, for example, copper, silver and steel, can be used, however, depending on the desired use for the sensing probe and the subject media; the materials may be selected to be durable and compatible for the intended use. 25 Additionally, factors such as cost and ease of manufacture may dictate a different material selection. In one exemplary embodiment, the tip 5802 is made from copper. In other embodiments, the material can be an alloy of copper or silver, or either solid or an alloy of any thermally conductive material or element, including but not limited to metals and ceramics. However, in the exemplary' embodiments, the tip 5802 is made from metal 30 In the exemplary embodiment, the tip 5802 is shaped to couple thermally with a thermal well as described in the exemplary embodiment of the thermal wel l abo ve. In the exemplary·' embodiment as well as in other embodiments, the tip 5802 may be shaped to insulate the thermal sensor 5808 from the ambient. In the exemplary embodiment, the tip 5802 is made from metal. 16 1ft alternate embodiments a non-electricaily conductive material is used for the tip. These embodiments may be preferred for use where it is necessary to electrically insulate the thermal well from the probe. In another alternate embodiment, the tip 5802 may be made from any thermally conductive ceramic. 2016204226 22 Jun2016 5 In the exemplary' embodiment, the thermal sensor 5808 is located in the housing and is attached to the interior of the tip 5802 with a thermally conductive epoxy 58.12, in the exemplary embodiment, the epoxy used is THERMALBOND, however, in other embodiments; any thermal grade epoxy can he used. However, in alternate embodiments, thermal grease may be used, in alternate embodiments, an epoxy or grease is not used, to The thermal sensor 5808, in the exemplary embodiment, is a thermistor. The thermistor generally is a highly accurate embodiment. However in alternate embodiments, the thermal sensor 5808 can be a thermocouple or any other temperature sensing device.

The choice of thermal sensor 5808 may again relate to the intended use of the sensing apparatus. 15 Leads 5814 front the thermal sensor 5808 exit the back of the housing 5804.

These leads 5814 attach to other equipment used for calculations. In the exemplary embodiment, a third lead 5816 from the tip 5802 is also included. This third lead 5816 is attached to the tip on a tab 5818. The third lead 5816 is attached to the tip 5802 because in this embodiment, die tip 5802 is metal and the housing is plastic. In alternate embodiments, 20 the housing 5804 is metal, dms die third lead 5816 may be attached to the housing 5804. Thus, the tip 5802, in the exemplary embodiment, includes a tab 5818 for attachment to a lead. However, in alternate embodiments, and perhaps depending on the intended use of the sensing apparatus, the third lead 5816 may not be included. Also, in alternate embodiments where a third lead is not desired, the tip 5802 may not include the tab 5818. Referring now 25 to FIG. 9, an exploded view of the sensing probe 5800 is shown.

Referring now to FIG. 10 an alternate embodiment of the exemplary' embodiment is shown, in this embodiment, tire tip 6002 of the sensing probe is shown. The tip 6002 includes a zone 6004 that will contact either a subject media to be tested or a thermal well. A zone 6006 attaches to the .sensor probe housing (not shown). An interior 30 area 6008 accommodates the thermal sensor (not shown). In this embodiment, the tip 6002 is made from, stainless steel. However, in other embodiments, the tip 6002 can be made from any thermally conductive material, including but not limited to: metals (including copper, silver, steel and stainless steel), ceramics or plastics. 17

In the exemplary embodiment, zone 600b includes a tab 6010. A third lead (as described with respect to FIG. 8,5816) attaches from the tab 6010. Referring next to FIGS. 2016204226 22 Jun2016 11A and 1 IB, the sensing probe 6000 is shown including the tip 6002 and the housing 6012. In one embodiment, the housing 6012 is made from any thermally insuiative material, 5 including but not limited to, plastic. In one embodiment, the housing 6012 is press fit to the tip 6002, glued or attached by any other method, in one embodiment, the thermal sensor 6014 is thermally coupled to the tip 6002 with thermal grade epoxy or, in alternate embodiments, thermal grease 6022. Two leads 6016 from tire thermal sensor 6014 extend to the distal end of the housing. In some embodiments, a third lead 6018 is attached to the 10 tip 6002 from the tab 6010. As discussed above, in some embodiments where the third lead is not desired, the tip 6002 does not include a tab 6010.

Referring now to FIG. 1 IB, an alternate embodiment of the sensing probe 6000 is shown. In this embodiment, the housing 6012 is a plastic molded over zone 6006 of the tip 6002 and the leads 6016, and in some embodiments, a third lead 6018. 15 10001] Referring now to FIG. 12, a full side view of one embodiment of the sensing probe 6000 shown in FIGS. KM IB is shown. The sensing probe 6000 includes a housing 6012, a tip 6002 and the leads 6016, 6018. Flange 6020 is shown. In some embodiment, flange 6020 is used to mount and/or attachment to equipment.

Referring now to FIG. 13A, the sensing probe 6000 shown in FIGS. 10-12, is 20 shown coupled to a thermal well 5100 which is fastened into a .fluid line 5108. In the embodiment as shown, two leads 6016 are shown at the distal end of the sensing probe 6000. And, in some embodiments, a third lead 6018 is also incorporated into the sensing probe 6000, FIG. 13B shows an alternate embodiment where the sensing probe 6000 includes two leads 6016 but does not include the third lead 6018. 25 Referring now to both FIGS. 13A and 138. the tip 6002 of the sensing probe 6000 is in direct contact with the thermal well 5100. Referring back, to FIG. 4 and still referring to FIG. ISA and I3B the thermal well 5100 includes a zone 5402. The thermal well 5100 is hollow, and the inner part, of zone 5402 is formed such that it will be in mating contact with the sensing probe tip 6002. As shown in this embodiment, the thermal well 30 5100 is designed to have a mating geometry with the sensing probe 6000. Thus, the geometry of the thermal well 5100 may depend on the geometry of the tip 6002 of the sensing probe 6000 and vice-versa. In some embodiments, it may be desirable that the sensing probe 6000 does not have a tight fit or a perfect mate with the thermal well 5100. 18

Referring now to FIG. 14 A, one embodiment of the sensing probe 5800 (as shown in FIG. 8) is shown coupled to a thermal well 5100 which is fastened into a fluid line 5108. In the embodiment as shown, two leads 5814 are shown at the distal end of the 2016204226 22 Jun2016 sensing probe 5800. In some embodiments, a third lead 5816 is also incorporated into the 5 sensing probe 5800. FIG. I4B shows an alternate embodiment where the sensing probe 5800 includes two leads 5814 but does not include the third lead 5816.

Referring now to both FIGS. I4A and 14B, the tip 5802 of the sensing probe 5800 is in direct contact with the thermal well 5100. Referring back to FIG. 4 and still referring to FIG. 14A and 14B, the thermal well 5100 includes a zone 5402. The thermal 10 well 5100 is hollow, and the inner part, of zone 5402 is formed such that it will be in mating contact with the sensing probe tip 5802. As shown in this embodiment die thermal well 5100 is designed to have a mating geometry with tire sensing probe 5800. Thus, the geometry of the thermal well 5100 depends on the geometry of the tip 5802 of the sensing probe 5800 and vice-versa.

15 3. SENSOR APPARATUS AND SENSOR APPARATUS SYSTEMS

3.1. SENSOR APPARATUS AND SENSOR APPARATUS SYSTEMS UTILIZED IN

CONNECTION WITH A. FLUID LINE

For purposes of description of the sensor apparatus, the sensor apparatus is described with respect to exemplary embodiments. The exemplary embodiments are shown 20 in FIGS. 13A, 13B, and FIG. 15, with alternate exemplary embodiments in 14A and 14B.

In alternate embodiments of the sensor apparatus, the sensing probe can be used outside of the thermal, well. However, the sensor apparatus has already been described herein alone. Thus, the description that follows describes one embodiment of the exemplary embodiment of the sensor appara tus which includes, for th is purpose, a sensing probe and a thermal well. 25 Referring now to FIG. 1.5, in an exemplary embodiment, tire sensing probe 6000 shown in FIG. 13 A. and the thermal well 5100 are shown coupled and. outside of a fluid line. As described above, the thermal well 5100 can be in a fluid line, a protective sleeve, any disposable, machine, chamber, cassette or container. However, for purposes of this description of the exemplary embodiment, the thermal, well 5100 is taken to be anywhere 30 where it is used to determine thermal and/or conductive properties (FIG. 13A) of a subject media. A subject media is in contact with the outside of zone 5402 of the thermal well 51.00. Thermal energy is transferred from the subject media to the thermal well 5100 and. further transferred to the tip 6002 of the sensing probe 6000. Thermal energy is then .19 conflicted to the thermal sensor 6014, The thermal sensor 6014 communicates via leads 6016 with equipment that can determine the temperature of die subject media based on feedback of the thermal sensor 6014. In embodiments where conductivity sensing is also desired, lead 6018 communicates with equipment that can determine the conductivity of the 5 subject media. With respect to determining the conductivity of the subjec t media, in 2016204226 22 Jun2016 addition to the lead 6018, a second electrical iead/contact (not shown) would also be used. The second lead could be a second sensor apparatus as shown in FIG. 15, or, alternatively, a second probe that is not necessarily the same as the sensor apparatus shown in FIG. 15, but rather, any probe or apparatus capable of sensing capacitance of the subject media, t o including, an electrical contact.

Heat transfer from the tip 6002 to the thermal sensor 6014 may be improved bv the use of a thermal epoxy or thermal grease 6022.

Referring now to FIGS. 1.4A and I4B, in the alternate exemplary embodiment, whilst fee sensing probe 5800 is coupled to fee thermal well 5100, the tip 5802, having the 15 geometry shown, forms an air gap 6402 between fee inner zones 5404 and 5406 of the thermal well 5100 and the tip 5802. The air gap 6402 provides an insulative barrier so that only the top of fee sensing tip of 5802 is in communication wife the top zone 5402 of the thermal well 5100.

The sensing probe 5800 and thermal well 5100 are shown coupled and outside 20 of a fluid line. As described above, the thermal well 51.00 can be in a fluid line, a protective sleeve, disposable unit, machine, non-disposable unit, chamber, cassette or container. However, for purposes of this description of the exemplary embodiment, the thermal ive.ll 5100 is taken to be anywhere where it is used to determine thermal and/or conductive properties (FIG. .14A.) of a subjec t media. 25 A subject media is in contact with the outside of zone 5402 of the thermal well 5100. Thermal energy is transferred from fee subject media to fee thermal well 5100 and further transferred to the tip 5802 of fee sensing probe 5800. Thermal energy is then conducted to fee thermal sensor 5808. The thermal sensor 5808 communicates via leads 5814 wife equipment that can determine the temperature of fee subject media based on 30 feedback of fee thermal seusor 5808. In embodiments where conductivity sensing is also desired, lead 5816 communicates wife equipment feat can determine fee conductivity of the subj ect media. Wife respect to determining the conductivity of the subject media, in addition to the lead 5816, a second electrical lead (not shown) would also be used. The second lead could be a second sensor apparatus as shown in FIG. 14A, or, alternatively, a 20 second probe that is not necessarily the same as the sensor apparatus shown in FIG. 14A, but rather, any probe or apparatus capable of sensing capacitance of the subject media, including, am electrical contact. 2016204226 22 Jun2016 I leal transfer from the tip 5802 to the thermal sensor 5808 can be improved by 5 the use of a thermal epoxy or thermal grease 5812.

Referring now to FIG. 16, an alternate embodiment showing a sensing probe 6602 coupled to a thermal well 5100 is shown. For purposes of this description, any embodiment of the sensing probe 6602 and any embodiment of the thermal well 5100 can he used. In this embodiment, to increase the thermal co upling between the tip of the 10 sensing probe 6602 and the thermal well 5100, thermal grease 6604 is present at the interlace of the tip of the sensing probe 6602 and the inner zone 5402 of the thermal well 5100. In one embodiment, the amount of thermal grease 6604 is a volume sufficient to only be present in. zone 5402. However, in alternate embodiments, larger or smaller volumes of thermal grease can be used. 15 Referring now to FIG. 1.7, a sensor apparatus system is shown, in the system, the sensor apparatus is shown in a device containing a fluid line 5108. The sensor apparatus includes the sensing probe 6000 and the thermal well 5100. In this embodiment, the thermal well 5100 and .fluid line 5108 is a disposable portion and the sensing probe 6000 is a reusable portion. Also in the reusable portion is a spring 6700. The spring 6700 and 20 sensing probe 6000 are located in a housing 6708. The housing 6708 can be in any machine, container, device or otherwise. The spring 6700 can be a conical, a coil spring, wave spring, or urethane spring.

In this embodiment, the thermal well 5100 and the sensing probe 6000 may include alignment features 6702,6704 that aid in the thermal well 5100 and sensing probe 25 6000 being aligned. The correct orientation of the thermal well 5100 and the sensing probe 6000 may aid in the mating of the thermal well 5100 and the sensing probe 6000 to occur. The configuration of the space 6706 provides the sensing probe 6000 with space for lateral movement. This allows the sensing probe 6000 to, if necessary; move laterally in order to align with the thermal well 5.1.00 for mating. 30 The sensing probe 6000 is suspended by a spring 6700 supported by the flange 6020. The spring 6700 allow vertical movement of the .sensing probe 6000 when the thermal well 5100 mates with the sensing probe 6000. The spring 6700 aids in establishing full contact of the sensing probe 6000 and the thermal well 5100. 21

The fluid line 5108 can be in any machine, container, device or otherwise. The fluid Hue 5108 contains a fluid path 5104. A subject media flows through the fluid path 5104 and the thermal well 5100, located in the fluid line 5108 such that the thermal well 5100 has ample contact with the fluid path 5104 and can sense the temperature properties 5 and, in some embodiments, the conductive properties of the subject- media. The location of the thermal well 5100 in the fluid path 5104, as described in more detail above, may be related to the desired accuracy, the subject media and other considerations. 2016204226 22 Jun2016

The spring 6700 and sensing probe 6000 assembly, together with the space 6706 in the housing 6708 may aid in alignment for the mating of the sensing probe 6000 and die to thermal well 51.00. The mating provides the thermal contact so that the thermal well 5100 and the sensing probe 6000 are thermally coupled. A wire 6710 is shown. The wire contains the leads. In some embodiments, there are two leads. Some of these embodiments are temperature sensing. In other embodiments, the wire contains three or more leads. Some of these embodiments are for 15 temperature and conductivity sensing.

Referring now to FIG. 18, an alternate embodiment of die system shown in FIG. 17 is shown. In this embodiment, the sensing probe 6000 is suspended by a coil spring 6800. A retaining plate 6802 captures die coil spring 6800 to retain the spring 6800 and sensing probe 6000. In one embodiment, die retaining plate 6802 is attached to the housing 20 6708 using screws. However, in alternate embodiments, the retaining plate 6802 is attached to the housing 6708 using any fastening method including but not limited to: adhesive, flexible tabs, press fit, and ultrasonic welding. A ligning features 6806 on the housing 6708 aid in alignment of the sensing probe 6000 to a. thermal well (not shown). Lateral movement of the sensing probe 6000 is provided for by c learance in areas 6808 in the 25 housing 6708. A wire 6710 is shown. 'l ire wire contains the leads. In some embodiments, there are two leads. Some of these embodiments are temperature sensing. In other embodiments, the wire con tains three or more leads. Some of these embodiments are for temperature and conductivity sensing.

Referring now to FIG. 19, a sensing probe 6000 is shown in a housing 6708. in 30 these embodiments, an alternate embodiment of a. spring, a flexible member 6900, is integrated with the sensing probe 6000 to allow vertical movement of the sensing probe 6000 within the housing 6708. A retaining plate 6902 captures the flexible member 6900 to retain the flexible member 6900 and sensing probe 6000. In one embodiment, the retaining plate 6902 is attached to the housing 6708 using screws. However, in alternate embodiments, the retaining plate 6902 is attached to the housing 6708 using any fastening method including but not limited to: adhesive, flexible tabs, press fit, and ultrasonic welding. Lateral movement of the sensing probe 6000 is provided for by clearance in. areas 6908 in the housing 6708. A ware 6710 is shown. The wire contains the leads, hr some 5 embodiments, there are two leads. Some of these embodiments are temperature sensing, in other embodiments, the wire contains three or more leads. Some of these embodiments are for temperature and conductivity sensing. 2016204226 22 Jun2016

Referring now to FIG; 20, an alternate embodiment of a sensing probe 6000 in a housing 7002 is shown, in this embodiment, flexible member 7000 is attached or part of the io housing 7002, provides for vertical movement of the sensing probe 6000. In this embodiment, the openings 7004, 7006 in housing 7002 are sized such that die sensing probe 6000 experiences limited lateral movement. Flexible member 7000 acts on the flange 7008 on the sensing probe 6000. A wire 6710 is shown. The wire contains the leads. In some embodiments, there are two leads. Some of these embodiments are temperature sensing. In 15 other embodiments, the wire contains three or more leads. Some of these embodiments are for temperature and conductivity sensing.

The flange, as shown and described with respect to FIGS. 12, 17, 20, can be located in any area desired on the sensing probe 6000. In other embodiments, the sensing probe may be aligned and positioned by other housing configurations. Thus, the 20 embodiments of the housing shown herein are only some embodiments of housings in which the sensor apparatus can be used. The sensor apparatus generally depends on being located amply with respect to the subject media. The configurations that accomplish this can vary depending on the subject media and the intended use of the sensing apparatus. Further, in some embodiments where tire thermal well is not used, but rather, the sensing 25 probe is used only. The housing configurations may vary as well.

The sensing apparatus, in some embodiments, is used to sense conductivity. In some embodiments, this is in addition to temperature sensing. In those embodiments where both temperature and conductivity sensing is desired, the sensing probe typically includes at least three leads, where two of these leads may be used for temperature sensing and the third 30 used for conductivity sensing.

Referring now to FIG. 21, for conductivity sensing, at least two sensors 7102, 7104 are located in an area containing the subject media. In tire embodiment shown, the area containing the subject media is a fluid path 5:104 inside a fluid line 5108. The conductivity sensors 7102,7104 can be one of the various embodiments of sensing probes as described above, or one of the embodiments of the sensor apparatus embodiments (including the thermal well) as described above. However, in other embodiments, only one of the sensors is one of the embodiments of the sensor apparatus or one of the embodiments of the sensing probe, and the second sensor is any electrical sensor known in the art. Thus, 5 in the systems described herein, conductivity and temperature can be sensed through using either one of the sensor apparatus or one of the sensor probes as described herein and a second capacitance sensor, or one of the sensor apparatus or one of the sensor probes as described herein and an electrical sensor. 2016204226 22 Jun2016

Referring now to FIG. 22, an alternate embodiment of a sensor apparatus 10 including a sensing probe 7200 and a thermal well 5100 is shown in a fluid line 5108. In this embodiment, the sensing probe 7200 is constructed of a metal housing. The thermal well 5100 is also constructed of metal. The thermal well 5100 and the sensing probe 7200 can be made from, the same metal or a different metal The metal, in the preferred embodiment, is a conductive metal, which may include stainless steel, steel, copper and 15 silver. A lead 7202 is attached to the sensing probe 7200 housing for conductivity sensing. The thermal sensing leads 7204 are attached to a thermal sensor located inside the sensing probe 7200 housing, in this embodiment, therefore, the third lead 7202 (or the lead for conductivity sensing) can be attached anywhere on the sensing probe 7200 because the sensing probe 7200 is constructed of metal. In the previously described embodiments, 20 where the sensing probe h ousing was constructed of plastic, and the sensing tip constructed of metal, the third lead for conductivity sensing was attached to the sensing tip. A known volume of subject media may be used to determine conductivity.

Thus, two sensors may be used and the volume of fluid between the two sensors can be determined. Conductivity sensing is done with the two electrical contacts (as described 25 above), where one or both can be tire sensor apparatus. The volume of subject media between the two contacts is known. 30

Conductivity sensing is done by determining the conductivity from each of the sensors and then determining the difference, if the difference is above a predetermined threshold, indicating an abnormal difference in conductivity between the first and second sensor (the designations “first” and “second” being arbitrary), then it can be inferred that air maybe trapped in the subject media and a bubble detection alarm may be generated to indicate a bubble. Thus, if there is a large decrease in conductivity (and likewise, a large increase in resistance) between the first and second sensor, air could be trapped and bubble presence may he detected 24

Leaks in a machine, system, device or container may be determined using the conductivity sensing. Where a sensing apparatus is in a machine, device or system, and that sensing apparatus senses conductivity, in one embodiment, a lead from the sensor apparatus (or electrical contacts) to an analyzer or computer machine may be present. 2016204226 22 Jun2016

In some embodiments, the analyzer that analyzes the electrical signals between the contacts is connected to the metal of die machine, device, system or container. If the analyzer senses an electrical signal from die machine, then a fluid leak may be inferred.

3.2. SENSOR APPARATUS AND SENSOR APPARATUS SYSTEMS UTILIZED IN CONNECTION WI TH A FLUID CASSETTE 10 The cassette embodiments shown and described in this description include exemplary and some alternate embodiments. However, any variety of cassettes are contemplated that include similar or additional functionality. As well, the cassettes may have varying fluid paths and/or valve placement and may utilize pumping functions, valving functions, and/or other cassette functions. All of these embodiments are within die scope of i5 the invention.

3.2.L FLEXIBLE MEMBRANE FLUID CASSETTE

Fluid cassettes, including flexible membrane fluid cassettes of the types described in U.S. Patent Nos.: 5,350,357 issued September 27, 1994 and endtledlPeritoneal Dialysis Systems And Methods Employing A Liquid Distribution And Pumping Cassette 20 That Emulates Gravity Flow; 5,755,683 issued May 26,1998 and entitled Cassette For

Intravenous-Line Flow-Control System; 6,223,130 issued April 24, 2001 entitled Apparatus And Method For Detection. Of A Leak In A Membrane Of A Fluid Flow Control System; 0,234,997 issued May 22, 2001 entitled System And Method For Mixing And Delivering Intravenous Drugs; 6,905,479 issued June 14, 2005 entitled Pumping Cartridge Having An 25 Integrated Filter And Method For Filtering A Fluid With The Cartridge; and U.S. Patent Applications: 10,412,658 filed April 10. 2003 entitled System And Method For Delivering A Target Volume Of Fluid; and 10/696,990 filed October 30,2003 entitled Pump Cassette Bank, all of which are hereby incorporated herein by reference in their entireti es, may be used in conjunction with the sensor apparatus and sensor apparatus systems described 30 herein. F IGS. 23A-C show an exemplary embodiment of a flexible membrane cassette of a similar type to those generally disclosed in U.S. Patent 5,350,357 and other of the patents and patent applications referenced above. Figures 23A-C shows back, side, and front views of exemplary cassette 2300. As FIGS . 23 A-C show, the cassette 2306 includes an injection molded body having back side 2310 shown in. FIGS. 23 A and front side 2311 shown in FIG. 23C. A flexible diaphragm (one of which is shown as 59 in FIG. 24} overlies the front side and back side of cassette 2300. 2016204226 22 Jun2016

The cassette 2300 is preferably made of a rigid plastic material and die 5 diaphragms are preferably made of flexible sheets of plastic, although many other materials may be utilized.

Exemplary cassette 2300 forms an array of interior ca vities in the shapes of wells and channels. In exemplary cassette 2300, the interior cavities create multiple paths, such as fluid path 2303, to convey liquid (as FIG . 23A shows). In exemplary cassette 2300, H) the interior cavities also create pump chambers, such as pump chambers 2301 and 2302 (as FIG, 23C shows) and multiple valve stations, such as valve station 2304 (as FIG. 23C shows). In the exemplary cassette 2300, the valve stations, such as valve station 2304, interconnect the multiple liquid paths, such as fluid path 2303, with pump chambers 2301 and 2302 and with each other. 15 hi certain embodiments, exemplary cassette 2300 may be utilized in conjunction with a device (not shown) that locally applies positive and negative pressure, including positive and negative fluid pressure of the type described in U.S. Patent 5,350,357 and other of the patents and patent applications referenced above, on die diaphragm regions overlying the valve stations aid pump chambers. While many different types of pump chambers and 20 valves may be utilized with cassette of the types described herein (or, in certain embodiments, not included at all), exemplary pump chambers and valve stations of the type shown in FIGS, 23A-C are described in more detail in U.S. Patent 5,350,357, incorporated herein. The presence, number, and arrangement of the pump chambers, liquid paths, and valve stations can vary. Additionally, alternative or additional cassette functionality may be 25 present in a given cassette.

With further reference to FIGS. 23A~C, exemplary cassette 2300 includes sensor ports 2305 and 2306 that extend into fluid path 2303. Sensor ports 2305 and 2306 may be used to insert a sensing probe, thermal well or other sensing element to allow. Exemplary cassette 2300 shows two sensor ports per cassette, but one port, two ports, or more than two 30 ports may be used depending on the configuration of the cassette and the type of sensor or sensors used.

Again, with reference to FIG. 23A-C, exemplary cassette 2300 is shown with sensor ports 2305 and 2306 position in the rigid body of cassette 2300. In the case of a rigid cassette body with two flexible membranes, one on either side of the rigid body , as shown 26 in FIG. 23A-C, in one embodiment sensor ports 2305 and 2306 may be position in the rigid body portion of the cassette (as shown best in FIG. 23B), However, in other embodiments, the sensor port may extend though one or more areas of the flexible diaphragm overlying the cassette. 2016204226 22 Jun2016 5 Referring now to FIG. 24, exemplary cassette 2300 is shown with sensor ports 2305 and 2306 extending into fluid path 2303 such that a component placed in sensor ports 2305 and 2306 would come into direct contact with the subject media contained in or flowing through fluid path 2303. FIG, 24 additionally shows thermal wells 5100 positioned near sensor ports 2305 and 2306. In this embodiment, cassette 2300 and thermal wells 5100 to are separate parts. In some embodiments, the cassette 2300 and the thermal well 5100 are made from different materials. For these embodiments, the thermal well 5100 can be made from any materials, including but not limited to, plastic, metal, ceramic or a combination thereof. The material may depend in some part on the compatibility with the intended subject media. In other embodiments, thermal well 5100 could be made from the same 15 material as cassette 2300. In yet further embodiments, thermal well 510ft could be formed as a pari of the structure of the rigid body of cassette 2300.

The length and width of the thermal well 5100 utilized with exemplary cassette 2300 can be any length and width having the desired or tolerable accuracy characteristics and which properly positions any sensor or sensing probe utilized with thermal well 5100 20 sufficiently in contact with the subject media contained in or flowing through fluid path 2306. lire length of thermal well 5100 may impact the fluid flow of the subject media in fluid path 2303 to a certain extent It also should be understood that the length of the thermal well 5100 may also impact the turbulence of the fluid flow. Thus, the length and width of the thermal well 5100 may be changed to have greater or lesser impact on the fluid 25 flow' and turbulence of the fluid, while mitigating the other variables.

The shape of the thermal well 5100 is also a variable. Any shape desired is contemplated. However, the shape of the thermal well 5100, as with the other variables, is determined in part based on the intended use of the sensor apparatus. For purposes of description, an exemplary embodiment is described herein. However, the shape in the 30 exemplary embodiment is not meant to be limiting. All of the various embodiments of thermal wells described herein may be used in conjunction with cassettes, such as exemplary' cassette 2300. FIG. 25 shows thermal wells 5100 installed in exemplary cassette 2300. T hermal well 5100 may be installed in exemplary cassette 2300 bv use of the ways described herein, including adhesive, welding (ultrasonic and otherwise), o-ring, retaining plate, and otherwise- The thermal well 5.100 used in connection with a cassette may be of 2016204226 22 Jun2016 various shapes and configurations. However, referring now to FIG. 4 for purposes of description, the embodiment of a thermal well 5100 shown may be utilized in conjunction 5 with a cassette, in the exemplary embodiment shown in FIG. 4, the bottom zone 5406 is shaped to aid in press fitting the thermal, well into the sensor port 2305 shown in FIGS. 23A-C and 24. FIG. 26 further shows thermal well 5100 installed in sensor port 2305 and 2306.

As may be best shown by FIG, 27, thermal well 5100 extends into fluid path 2303 so that to thermal well 5100 may come into direct contact with any subject media contained in or flowing through exemplary cassette 2300,

In certain embodiments of sensor apparatus and sensor apparatus systems used in conjunction with a flexible membrane cassette, a sensing probe may be installed directly into sensing ports 2305 and 2306 (sensing ports 2305 and 2306 as shown in. FIGS. 23A-C 15 and 24). In further embodiments of sensor apparatus and sensor apparatus systems used in conjunction with a flexible membrane, a sensing probe may be used with a thermal well.

As can be seen in FIG . 27, subject media is in contact with the outside of zone 5402 of the thermal well 5100, Thermal energy is transferred from the subject media to the thermal welt 5100, As may be seen with reference to FIG. I3A-B, the thermal energy can 20 them be .further transferred to the tip 6002 of the sensing probe 6000, Thermal energy is then conducted to the thermal sensor 6014. The thermal sensor 6014 communicates via leads 60.16 with equipment that can determine the temperature of the subject media based on feedback of the thermal sensor 6014, In embodiments where conductivity sensing is also desired, lead 6018 communicates with equipment that can determine the conductivity of the 25 subject media. With respect to determining the conductivity of the .subject media, in addition to the lead 6018, a second electrical lead/contact (not shown) would also be used. The second lead could be any probe or apparatus capable of sensing capacitance of the subject, media, including, an electrical contact.

Heat transfer from the tip 6002 to the thermal sensor 6014 may be improved by 30 the use of a thermal epoxy or thermal grease 6022,

Many different embodiments of sensing apparatus may be used in connection with a thermal well installed in a flexible cassette, including embodiments similar to those shown in FIGS. I4A-B, 15, and 16, and described above. 28

While several geometries have been described, many others could be shown to achieve desired performance characteristics. 2016204226 22 Jun2016

In certain embodiments, exemplary cassette 2300 may be utilized in conjunction with a device (not shown) that locally applies positive and negative pressure, including 5 positive and negative fluid pressure of the type described in U.S. Patent 5,350,357 and other of the patents and patent applications referenced above, on the diaphragm regions overlying the valve stations and pump chambers. When cassette 2300 is utilized in conjunction with a pressure applying device (not shown), cassette 2300 may be connected to the device in a number of different ways and in a number of different positions. Preferably , in certain 10 embodiments, cassette 2300 may be loaded in a device in other than a. horizontal orientation, such as a vertical or substantially vertical orientation. Placement of the cassette in a vertical or substantially vertical orientation may offer certain advantages depending on the configuration of the cassette such as to avoid ah: entrapment and to optimize application of positive and negative pressure, including positive and negative fluid pressure of the type 15 described in U .S. Patent 5,350,357 and other of the patents and patent applications referenced above, to the cassette.

Referring now to FIG. 28, a sensor apparatus system of the type generally shown may be used in connection with exemplary cassette 230(1. In the system, the sensor apparatus is installed in sensor ports 2305 and 2305 (not shown) extending into fluid path 20 2303. The sensor apparatus includes the sensing probe 6000 and the thermal well 5100. In this embodiment, the thermal well 5100 and fluid line 2303 is contained in an exemplary cassette 2300. In certain embodiments, exemplary cassette 2300 is intended to be disposable. Sensing probe 6000 is mounted in a reusable portion. Also in the reusable portion is a spring 2801. The spring 2801 and sensing probe 6000 are located in a housing 25 2800. The housing 2800 can be in any machine, container, device or otherw ise. In certain embodiments the reusable portion in contained in or otherwise a part of a pressure applying device (as described above). The spring 2801 can be a conical, a coil spring, wave spring, or urethane spring.

In certain embodiments, the thermal well 5100 and the sensing probe 6000 may 30 include alignment features (of the type shown in FIG. 17, 6702, 6704) that aid in the thermal well 5100 and sensing probe 6000 being aligned. The correct orientation of the thermal well 5100 and the sensing probe 6000 may aid in the mating of the thermal well 5100 and the sensing probe 6000 to occur. Referring again to FIG. 28, the configuration of the housing 2800 may provide the sensing probe 6000 with space for lateral movement. 29

This allows the sensing probe 6000 to, if necessary; move laterally in order to align with the thermal well 5100 for mating. 2016204226 22 Jun2016

In various embodiments, the sensing probe 6000 is configured with respect to the housing 2800 (as shown in FIG. 28) to facilitate engagement between the sensing probe 5 6000 and the thermal well 5100 and to aid in establishing full contact of the sensing probe 6000 and the thermal well 5100. Variations of the configurations generally shown in FIGS. 18-20 and described above may be used in conjunction with exemplary cassette 2300. in other embodiments, the sensing probe may be aligned and positioned by other housing configurations. Thus, the embodiments of the housing shown herein are only some to embodiments of housings in which the sensor apparatus can be used. The sensor apparatus generally depends on being located amply with respect to the subject media. Hie configurations that accomplish this can vary depending on the subject media and the intended use of the sensing apparatus. Further, in some embodiments where the thermal well is not used, but rather, the sensing probe is used only. The housing configurations may 15 vary as well.

In embodiments in which cassette 2300 is loaded into a device, such as a pressure applying device, in a vertical or substantially vertical orientation, it may be preferable for sensor ports 2305 and 2306 to be positioned in the bottom edge of cassette 2300 (the bottom edge as the cassette is shown in FIG. 23A). Positioning of the sensor 20 ports 2305 and 2306 along the bottom edge of exemplary cassette 2300 (such that sensor ports 2305 and 2306 and installed thermal wells 5100 extend into the bottom fluid line 2303 of the cassette) may facilitate engagement with the sensor apparatus as shown in FIG. 28.

In certain of these embodiments, the exemplary'' cassette 2300 with installed thermal wells 51.00 may be placed in position over sensor probes 6000, and then rotated vertically down 25 and onto the sensor probes 6000.

The sensing apparatus, in some embodiments, is used to sense conductivity of the subject media within a fluid line within a cassette. In some embodiments,, this is in addition to temperature sensing. In those embodiments where both temperature and conductivity sensing is desired, the sensing probe typically includes at least three leads, 30 where two of these leads may be used for temperature sensing and the third used for conductivity sensing.

Referring now to FIG. 21, for conductivity sensing, at least two sensors 7102, 7104 are located in an area containing the subject media. In the embodiment shown, the area containing the subject media is a fluid path 5104 inside a fluid line 5108. The 30 conductivity sensors 7102,7104 can be one of the various embodiments of sensing probes as described abo ve, or one of the embodiments of the sensor apparatus embodiments (including the thermal well) as described above. 2016204226 22 Jun2016

Referring now to FIG. 28, sensing probes 6000 installed in thermal wells 5100 5 in sensor ports 2305 and 2306 can be used for sensing the conductivity of the subject media located between sensor ports 2305 and 2306 in fluid line 2303. However, in other embodiments, only one of the sensors is one of the embodiments of the sensor apparatus or one of die embodiments of the sensing probe, a nd the second sensor is any electrical sensor known in the art. T hus, in the systems described herein, conducti vity and temperature can 10 be sensed through using either one of the sensor apparatus or one of the sensor probes as described herein and a second capacitance sensor, or one of the sensor apparatus or one of the sensor probes as described herein and an electrical sensor.

3.2.2. POD PUMP CASSETTE

Cassettes other than the flexible membrane cassette described above may be used in 15 conjunction with the sensor apparatus and sensor apparatus systems described herein.

Cassette, such as cassettes of the types described in Patent Application Serial No. 11/787,213 entitled Heat Exchange Systems, Devices and Methods which was filed on

April 13,2007 (E77); Patent Application Serial No. 11/787,213 entitled Fluid Pumping

Systems, Devices and Methods which was filed cm April 13,2007 (E78); and Thermal and 20 Patent Application Serial No. 11/787,213 entitled Conductivity Sensing Systems, Devices and Methods which was filed on April 13,2007 (E79), all of which are hereby incorporated herein by reference in their entireties, may be used in conjunction with the sensor apparatus and sensor apparatus systems described herein. Additionally, cassettes, cassette assemblies, and manifolds of the types described in the following applications may be used in 25 conjunction with the sensor apparatus and sensor apparatus systems described herein: U.S.

Patent Application Serial No. 11/871.680, filed October 12,2007 entitled Pumping Cassette (Attorney Docket No. DEKA-019XX); U.S. Patent Application Serial No.! 1/871,712, filed

October 12, 2007 entitled Pumping Cassette (Attorney Docket No. DEKA-020XX); U.S.

Patent Application Serial No. 11/871,787, filed October 1.2,2007 and entitled Pumping 30 Cassette (Attorney Docket No. DEKA-021XX); U.S. Patent Application Serial No. 11/871,793, filed October 12,2007 and entitled Pumping Cassette (Attorney Docket No. DEKA-022XX); and U.S. Patent Application Serial No. 11/871,803, filed October 12, 2007 and entitled Cassette System Integrated Apparatus (Attorney Docket No. DEKA-023XX).

Further, a variety of devices, including medical devices, such as the hemodialysis systems 31 and methods of the types described in U,S, Patent Application Serial No. 11/871,680, filed October 12,2007 entitled Pumping Cassette (Attorney Docket No. DEKA-019XX); as well as U.S. Patent Application entitled Hemodialysis System and Methods (Attorney Docket No. D057O/7OO19USO0) and U.S. Patent Application entitled Cassette System Integrated 5 Apparatus (Attorney Docket No. F62), which are being filed on even date herewith and are hereby incorporated herein by reference in their entirety. 2016204226 22 Jun2016

In an exemplary embodiment of other cassettes used in conjunction with the sensor apparatus and sensor apparatus systems described herein, the cassette includes a top plate, a midplate and a bottom plate. In general, the top plate includes pump chambers, and to potentially alternative or additional features; the midplate includes complementary fluid lines, metering pumps, valves and potentially alterative or additional features; and the bottom plate includes actuation chambers. In general, membranes are located between the midplate and the bottom plate; however, many alterative embodiments are possible. In the exemplary' embodiment, the cassettes are formed by placing the membranes in. their correct 15 locations, assembling the plates in order and laser welding the plates. The cassettes may be constructed of a variety of materials. Generally, in the various exemplary embodiment, the materials used are solid and non flexible. In the preferred embodiment, the plates are constaicted of polysilicone, but in other embodiments, the cassettes are constructed of any other solid material and in exemplary embodiment, of any thermoplastic. 20 FIG. 29 is a sectional view of an exemplary pump pod 100 that is incorporated into a fluid control or pump cassette, in accordance with an exemplary embodiment of the cassette. In this embodiment, the pump pod is formed from three rigid pieces, namely a “top” plate 106, a midpiate 108, and a “bottom” plate 110 (it should be noted that the terms “top” and “bottom” are relative and are used here for convenience with reference to the 25 orientation shown in FIG. 29). The top and bottom plates 106 and 110 include generally hemispheroid portions that when assembled together define a hemispheroid chamber, which is a pump pod 100. A membrane 112 separates the central cavity of the pump pod into two chambers.

Referring now to FIGS. 30A-B, in the exemplary embodiment of the cassette, 30 sensors are incorporated into the cassette so as to discern various properties of subject media contained in or flowing through the cassette, in various embodiments one sensor may be included to sense temperature and/or other properties of the subject media. In another embodiment, two sensors may be included, to sense temperature and/or conductivity and/or other properties of the subject media. In yet further embodiments, three 32 or more sensors may be included. However, in the exemplary embodiment, 6 sensors (2 sets of 3) are included. T he sensors are located in the sensor block 1314,1316. In this embodiment, a sensor block 1314,1316 is included as an area on the cassette for a sensor(s). In the exemplary embodiment, the three sensors of the two sensor blocks 1314, 2016204226 22 Jun2016 5 1316 are housed in respective sensor housings 1308,, 1310, 1312 and 1318,1320,1322. In the exemplary embodiment, two of the sensor housings 1308,1312 and 1318, 1320 accommodate a conductivity' sensor and the third sensor housing 1310,1322 accommodates a temperature sensor. The conductivity sensors and. temperature sensor can be any conductivity or temperature sensor in the art. In one embodiment, the conductivity sensor 10 elements (or sensor leads) are graphite posts. In other embodiments, the conductivity sensors elements are posts made from stainless steel, titanium, or any other material of the type typically used for (or capable of being used for) conductivity measurements, in certain embodiments, the conductivity sensors will include an electrical connection that transmits signals from the sensor lead to a sensor mechanism, controller or other device, in various } 5 embodiments, the temperature sensor can be any of the temperature sensors commonly used (or capable of being used) to sense temperature.

However, in alternate embodiments, a combination temperature and conductivity sensor is used of the types described above, in such alternate embodiments, thermal wells of the types described above may be installed in the cassette. In such embodiments, thermal 20 well 5100 may be installed in the cassette by use of any of the ways described herein, including adhesive, welding (ultrasonic and otherwise), ο-ring, retaining plate, and otherwise.

In alternate embodiments, there are either no sensors in the cassette or only a temperature sensor, only one or more conductivity sensors or one or more of another type of 25 sensor.

Referring now to FIGS. 3IA-13B. the bottom plate 1300 is shown. Referring first to FIGS. 31 A, the inner or inside surface of the bottom plate 1300 is shown. The inner or inside surface is the side that contacts the bottom surface of the midplate (not shown). The bottom plate .1300 attaches to the air or actuation lines (not shown). Hie corresponding 30 entrance holes for the air that actuates the pod pumps 820,928 and valves (not shown) in the midplate can be seen 1306. Holes 810,824 correspond to the first fluid inlet and first fluid outlet shown in FIGS. 30B, 810, 824 respectively. The corresponding halves of foe pod pumps 820,828 and mixing chamber 818 are also shown, as are foe raised fluid paths 1002 for the fluid paths. The actuation holes in foe pumps are also shown. Unlike the top plate, the bottom plate 1300 corresponding halves of the pod pomps 820, 828 and mixing chamber 818 make apparent the difference between the pod pumps 820 828 and mixing chamber 818. The pod pumps 820, 828 include an air/actuation path on the bottom plate 1300, while the mixing chamber 818 has identical construction to the half in the top plate. 2016204226 22 Jun2016 5 The mixing chamber 818 mixes liquid and therefore, does not include a membrane (not shown) nor an air/actuation path. The sensor block 1310,1316 with the three sensors housings 1308,1310,1312 and 1318,1320,1322 are also shown.

Referring now to FIGS. 3IB, the actuation ports 1306 are shown on the outside or outer bottom plate 1300. An actuation source is connected to these actuation ports 1306. H) Again, the mixing chamber 818 does not have an actuation port as it is not actuated by air. Referring to FIG. 31C, a side view of the exemplary embodiment of the bottom plate 1300 is shown.

Referring next to FIGS. 32A and 32B, the assembled exemplary embodiment of the cassette 1400 is shown. FIGS. 32C and 32D are exploded view of the exemplary 15 embodiment; of the cassette 1400. One embodiment of the conductivity sensors 1214,1216 and the temperature sensor 1218, which make up the sensor cell 1212, are also shown in FIGS. 32C and 32D, Still referring to FIGS. 32C and 32D, the sensors are housed in sensor blocks (shown as 1314,1316 in FIGS. SOB and 3FA) which include areas on the bottom plate 1300 and the midplate 1200. Ο-rings seal the sensor housings from the fluid lines 20 located on the upper side of the midplate 1200 and the inner side of the top plate 1100. However, in other embodiments, an o-ring is molded into the sensor block or any other me thod of sealing can be used.

Referring now' to FIGS. 33A-33C, various cross sectional views of the assembled cassette are shown. Referring now to FIG. 33B, the two conductivity sensors 1308,1312 25 and the temperature sensor 1310 are shown. As can be seen from the cross section, the sensors 1308,1310,1312 are in the thud line 824. Thus, the sensors 1308,1310,1312 are in fluid connection with the fluid line and can determine sensor data of the fluid exiting fluid outlet one 824. Still referring to FIG. 33B, a valve 826 cross section is shown.

Referring now to FIG. 33C, die two conductivity sensors 1318,1320 and the 30 temperature sensor 1322 are shown. As can be seen from the cross section, the sensors 1318,1320.1322 are in the fluid line 824. Thus, the sensors 1318, 1320,1322 are in fluid connection with the fluid line and can determine sensor data of the fluid entering the mixing chamber (not shown in this figure). 34

Thus, in the exemplary embodiment, the sensors 1318,1320,1322 are used to col Sect data regarding fluid being pumped into the mixing chamber. Referring back to FIG. 30B, sensors 1308,1310,1312 are used to collect data regarding fluid being pumped from the mixing chamber and to the fluid outlet. However, in alternate embodiments, no sensors 5 are or only one set, or only one type of sensor fi.e., either temperature or conductivity sensor) is used. Any type of sensor may be used and additionally, any embodiment of a temperature, a conductivity sensor or a combined temperature/conductivity sensor. 2016204226 22 Jun2016

3.3. SENSOR APPARATUS AND SENSOR APPARATUS SYSTEMS UTILIZED IN CONNECTION WI TH A MANIFOLD to FIG. 34 shows a system 10 in accordance with an exemplary embodiment of the present invention. System 10 includes a base unit 11 and a disposable unit 16 including a manifold. The disposable unit 16 is considered to be “disposable” in that it is generally discarded after a patient treatment, whereas the base unit 1.1. can be re-used repeatedly by simply installing a new disposable unit 16. 15 FIG. 35 show s relevant components of a disposable unit 16, in accordance with an exemplary embodiment of the present invention. The disposable unit 16 includes, among other things, a manifold 130, The disposable unit 16 preferably also includes a handle (not shown) that is used to mechanically interconnect the above-referenced components into a cohesive unit that can be readily installed into the base unit 11, which preferably includes a 20 manifold interface (described below) for receiving the manifold 130 and providing pneumatic and other connections. In this embodiment, the manifold 130 is integrated with the heat-exchanger bag 21 and is configured with appropriate tubing connections and supports that are used to interconnect the heat-exchanger bag 21 with the two pump pods 25a and 25b. in the embodiment shown in FIG. 35. the manifold '130 includes two flow-25 path inlets 23a and 23b (also referred to as “heat-exchanger bag inlets”) in fluid communication with one end of the fluid path 150 and a flow-path outlet 2? (also referred to as a “heat-exchanger bag outlet”) in fluid communication with the oilier end of the fluid path. 150. In alternative embodiments, manifold 1.30 may be used in connection with disposable unit 16 that does not include a heat-exchanger bag or other components shown in 30 FIG. 35. FIGS, 38 A and 38B respectively show a perspective back-side view and a perspective bottom view of die manifold 130 from FIG. 35, in accordance with an exemplary embodiment of the present invention. FIG. 38 A. shows bag inlet and outlet connectors 2053.. 2054 for connection at the inlet and outlet openings of the fluid channel 35 ISO of the bag 21. The bag inlet connector 2053 is in fluid communication with the inlets 23a, 231), while the bag outlet connector 2054 is in fluid communication with die outlet 27. The thermal wells 133a and 1.33b are shown in the outlet fluid path and the inlet fluid path, respectively. 2016204226 22 Jun2016 5 FIG. 13B show's a perspective back-side cross-sectional view of the manifold 130 of FIGS. 35,3SA, and 3SB, in accordance with an exemplary embodiment of the present invention. In this embodiment, the manifold 130 includes an inlet thermal well 133a located in a bag inlet 23a and an outlet thermal well 133b located in a bag outlet 27. The thermal wells 133a, 133b interface with corresponding probes in a manifold interface 10 of the base unit 11 (discussed below) when the disposable unit 16 is installed in the base unit 11. FIG. 13C shows a close-up view of an exemplary thermal well, although all of thermal well embodiments described herein may be utilized in connection with a manifold, such as manifold 130.

The thermal wells 133a, 133b provide for both thermal and electrical 15 interconnections between the base unit 11 and the disposable unit 16. Among other things, such thermal and electrical interconnections allow the controller 49 to monitor blood temperature as the blood enters and exits the heat-exchanger bag 21 and also allow the controller 49 to take other measurements (e.g., to detect the presence of blood or air in the heat-exchanger bag 21 and to perform leak detection) as discussed below, in this 20 embodiment, each of the thermal wells 133 a, 133 b is coupled so as to have a portion residing directly in the fluid path (i.e., in contact with the blood) so as to permit better transmission of blood temperature from the disposable unit 16 to the base unit 1.1. In lieu of, or in addition to, the thermal wells, the disposable unit 16 may include other temperature probes/sensors and interlaces by which the controller 49 can monitor blood temperature as 25 the blood enters and exits the heat-exchanger bag 21.

While the exemplary embodiment shown in FIGS. 8613, 38A, and 388 include thermal wells for transmitting thermal information to the base unit .11 and optionally for use in conductivity sensing, it should be noted that, other types of sensor components may be additionally or alternatively used. For example, rather titan using a thermal well, a sensor 36 component that sends temperature measurements or signals to the base unit 11 may be used. Various types and configurations of sensors are described below. In other embodiments, any of the sensor apparatus and sensor apparatus systems described herein may be used in conjunction with a manifold, such as manifold 130. FIG. 26 shows a close-up view of the manifold interface 2500 shown in FIG, 25, 2016204226 22 Jun2016 T he manifold interface 2500 includes, among other tilings, probes 61,62 and pneumatic ports 2539a, 2539b. With reference again to FIG. 1 IB, it can be seen that the manifold 130 can be installed in the manifold interface 2500 such that the probes 61,62 interface 5 respectively with the thermal wells 133a, 133b and the pneumatic ports 2539a, 2539b interface respectively with the pneumatic interfaces 139a, 139b. The manifold interface 2500 also includes a data key interface 2540 for interfacing with a corresponding data key in the disposable unit. The data key interface 2540 preferably provides a bi-directional communication interface through which the controller 49 can read information from the 10 disposable unit (e.g., serial/model number, expiration date, and prior usage information) and write information to the disposable unit (e.g., usage information). In an exemplary embodiment, the controller 49 may prevent the start of a treatment if the data key is not present or if the disposable unit is unusable, for example, because it includes an unacceptable serial/model number, is past a pre-con figured expiration date, or has already 15 been used. Hie controller 49 may terminate a treatment if tire data key is removed, in lieu of a data kev interface 2540. the base unit .11 or manifold interface 2500 mav include other types of interfaces for reading information from the disposable unit and/or writing information to the disposable unit (e.g., RFID, bar code reader, smart key interface).

It should be noted that one or more pumps (e.g,, pump pods) may be integral with, a 20 manifold such as the manifold 130 and placed in a base unit as a single cartridge. The assembly could include pneumatic connections from the pneumatic ports (which are connected to the base unit) directly to the pump actuation chambers so that no external tubing would be needed to make the pneumatic connections to the pump pods. The assembly could additionally or alternatively include fluidic connections (e.g., from the 25 pump outlets to the interface with the heat-exchanger bag) so that no external tubing would be needed between the pump outlets and the manifold or bag.

3.4. SENSOR APPARATUS AND SENSOR APPARATUS SYSTEMS UTILIZED IN CONNECTION WITH A SENSOR MANIFOLD

In various embodiments of the inventions described herein, a sensor apparatus 30 systems may be utilized that comprises a sensor manifold. A sensor manifold may allow subject media to be moved from one environment to another environment that is mote conducive to obtaining sensor readings. For example, the cassette manifold, may be contained in an area that is not subject to various types of environment conditions, such as temperature and/or humidity , which would not be preferable for sensor apparatus such as a 37 sensing probe. Alternatively, sensing apparatus and sensing apparatus system may be delicate and may be probe to greater malfunctions than other components of a system. Separating the sensor apparatus and the sensor apparatus systems from the remainder of the system by use of a sensor manifold may allow the sensing apparatus and sensing apparatus 5 systems to be repaired or replaced with minimal impact to the remainder of the system. Alternative, the sensor manifold may be replaced either more or less frequently than other components of the system. 2016204226 22 Jun2016

With reference to FIG. 39, an exemplary sensor manifold is shown, A subject media may he contained in or flow through cassette 3900. in this embodiment, cassette 3900 is 10 comprised of a rigid body overlaid by one or more flexible diaphragms of the types described herein, Pre-molded tube connector 3901 allows subject media to enter sensor cassette 3900 from another source and flow through fluid path 3903. Subject media exits the cassette through pre-molded tube connector 3902. While tube connectors 390.1. and 3902 are shown as pre-molded tube connectors, other embodiments may use any other fluid 15 transfer devices to allow subject, media into fluid path 3903,

With further reference to FIG. 39. cassette manifold 3900 includes sensor ports 3904,3905. and 3906 that extend into fluid path 3903. Sensor ports 3904,3905, and 3906 may be used to insert a sensing probe, thermal well or other sensing element to allow. Exemplary cassette manifold 3900 shows three sensor ports per cassette manifold, but any 20 number of ports may be used depending on the configuration of the cassette manifold and the type of sensor or sensors used.

Again, with reference to FIG. 39, exemplary cassette manifold 3900 is shown with sensor ports 3904,3905, and 3906 positioned in the rigid body of cassette manifold 3900,

In the case of a rigid cassette body with two flexible membranes, one on either side of the 25 rigid body, as shown in FIG. 39, in one embodiment sensor ports 3904, 3905, and 3906 maybe position in the rigid body portion of the cassette (as shown in FIG. 39). However, in other embodiments, the sensor port may extend though one or more areas of the flex ible diaphragm overlying the cassette manifold.

Referring again to FIG. 39, exemplary cassette manifold 3900 is shown with sensor 30 ports 3904,3905, and 3906 extending into fluid path 3903 such that a component placed in sensor ports 3904,3905, and 3906 would come into direct contact with tire subject media contained in or flowing through fluid path 3903. FIG. 39 additionally shows thermal wells 51.00 installed in sensor ports 3904,3905, and 3906. In certain embodiments, cassette manifold 2300 and thermal wells 5100 are separate parts, in some embodiments, the 38 cassette manifold 3900 and thermal well 5100 are made from different materials. For these embodiments, the thermal well 5100 can be made from any materials, including but not limited to, plastic, metal, ceramic or a combination thereof. The material may depend in some part on the compatibility with the intended subject media. In other: embodiments. 2016204226 22 Jun2016 5 thermal well 5100 could be made from the same material as cassette manifold 3900. In yet further embodiments, thermal well 5100 could be formed as apart of the structure of the rigid body of cassette manifold 3900.

The length and width of the thermal well 5100 utilized with exemplary cassette 2300 can be any length and width having the desired or tolerable accuracy characteristics and to which properly positions any sensor or sensing probe utilized with thermal well 5100 sufficiently in contact with the subject media contained in or flowing through fluid path 2306. Hie length of thermal well 5100 may impact the fluid flow of the subject media in fluid path 2303 to a certain extent It also should be understood that the length of the thermal well 5100 may also impact the turbulence of the fluid flow. Thus, the length and 15 width of the thermal well 5100 may be changed to have greater or lesser impact on the fluid flow' and turbulence of the fluid, while mitigating the other variables.

The shape of the thermal well 5100 is also a variable. Any shape desired is contemplated. However, the shape of the thermal well 5100, as with the other variables, is determined in part based on the intended use of the sensor apparatus. For purposes of 20 description, an exemplary embodiment is described herein. However, the shape in the exemplary embodiment is not meant to be limiting. All of the various embodiments of thermal wells described herein may be used in conjunction with cassettes, such as exemplary cassette 2300, FIG. 39 s'hmvs thermal wells 5100 installed in exemplary cassette manifold 3900. 25 T hermal well 5100 may be installed in exemplary cassette manifold 3900 by use of tire ways described herein, including adhesive, welding (ultrasonic and otherwise), o-ring, retaining plate, and otherwise. The thermal well 5100 used in connection with a cassette may be of various shapes and configurations. However, referring now to FIG . 4 for purposes of description, the embodiment of a thermal well 5100 shown may be utilized in 30 conjunction with a cassette, hr the exemplary embodiment shown in FIG. 4, the bottom zone 5406 is shaped to aid in press fitting the thermal well into the sensor port 2304,3905, and 3906 shown in FIG. 39. Subject media may come into contact with the outside of zone 5402 of the thermal well 5100 as described above. Thermal energy is transferred from the subject media to the thermal well 5100. As may be seen with reference to FIG. 13A-B, the 39 thermal energy can them be further transferred to the tip 6002 of the sensing probe 6000, Thermal energy is then conducted to the thermal sensor 6014. The thermal sensor 6014 communicates via leads 6016 with equipment that can determine the temperature of the subject media based on feedback of the thermal sensor 6014. In embodiments where 5 conductivity sensing is also desired, lead 6018 communicates with equipment that can determine the conductivity of the subject media. With respect to determining the conductivity of the subject media, in addition to the lead 6018, a second electrical lead/contact (not shown) would also be used. The second lead could be any probe or apparatus capable of sensing capacitance of the subject media, including, an electrical M) contact. 2016204226 22 Jun2016

Heat transfer from the tip 6002 to the thermal sensor 6014 may be improved by the use of a thermal epoxy or thermal grease 6022.

Many different embodiments of sensing apparatus may be used in connection, with a thermal well installed in a flexible cassette manifold, including embodiments similar to 15 those shown in FIGS. 14A-B, 15, and 16, and described above.

In certain embodiments of sensor apparatus and sensor apparatus systems used in conjunction with a flexible membrane cassette, a sensing probe may be installed directly into sensing ports 3904,3905, and 3906 (shown in FIG. 39). In further embodiments of sensor apparatus and sensor apparatus systems used in conj unction w ith a flexible 20 membrane, a sensing probe may be used with a thermal well.

In embodiments in which cassette manifold 3900 is used in conjunction with a sensing probe attached to a house, it may be preferable for sensor ports 3904,3905, and 3906 to be positioned in the bottom edge of cassette manifold 3900 (the bottom edge as die cassette manifold is shown in FIG. 39). Positioning of the sensor ports 3904,3905, and 25 3906 along the bottom edge of exemplary cassette manifold 3900 (such that sensor ports 2904,3905, and 3906 and installed thermal wells 5100 extend into the bottom fluid line 3903 of the cassette) may facilitate engagement with the sensor apparatus as shown in FIG. 28. in certai n of these embodiments, the exemplary cassette manifold 3900 with installed thermal wells 5100 may be placed in position over sensor probes 6000, and then rotated 30 vertically down and onto the sensor probes 6000.

While several geometries have been described, many others could be shown to achieve desired performance characteristics.

The sensing apparatus, in some embodiments, is used to sense conductivity of the subject media within a fluid line within a cassette, in some embodiments, this is in addition 40 to temperature sensing. In those embodiments where both temperature and conductivity sensing is desired, the sensing probe typically includes at least three leads, where two of these leads may be used for temperature sensing and the third used for conductivity sensing. 2016204226 22 Jun2016

Referring now to FIG. 21, for conductivity sensing, at least two sensors 7102, 7104 5 are located in an area containing the subject media. In the embodiment shown, the area containing the subject media is a fluid path 5104 inside a fluid line 5108. The conductivity sensors 7102, 7104 can be one of the various embodiments of sensing probes as described above, or one of the embodiments of the sensor apparatus embodiments (including the thermal well) as described above. 10 Referring now to FIG. 28, sensing probes 6000 installed in thermal wells 5100 in sensor ports 2305 and 2306 can be used for sensing the conductivity of the subject media located between sensor ports 2305 and 2306 in fluid line 2303. However, in other embodiments, only one of the sensors is one of the embodiments of the sensor apparatus or one of the embodiments of the sensing probe, and the second sensor is any electrical sensor 15 known in the art. Thus, In the systems described herein, conductivity and temperature can be sensed through using either one of the sensor apparatus or one of the sensor probes as described herein and a second capacitance sensor, or one of the sensor apparatus or one of the sensor probes as described herein and an electrical sensor.

For the various embodiments described herein, the cassette may be made of any 20 material, including plastic and metal. The plastic may be flexible plastic, rigid plastic, semi-flexible plastic, semi-rigid plastic, or a combination of any of these. In some of these embodiments the cassette includes one or more thermal wells. In some embodiments one or more sensing probes and/or one or more other devices for transferring information regarding one or more characteristics of such subject media are in direct contact with the 25 subject media. In some embodiments, the cassette is designed to hold fluid having a flow rate or pressure. In other embodiments, one or more compartments of the cassette is designed to hold mostly stagnant media or media held in the conduit even if the media has flow.

In some embodiments, the sensor apparatus may be used based on a need to separate 30 the subject media from the sensing probe. However, in other embodiments, the sensing probe is used for temperature, conductivity, and/or other sensing directly with subject media.

In some embodiments, the thermal well may be part of a di sposable portion of a device, machine, system or container. Thus, the thermal well may be in direct contact with 41 subject media and may be the only component that is contaminated by same, in these embodiments, the sensing probe may be part of a machine, device, system or container, and be disposable or non-disposable. 2016204226 22 Jun2016

With reference to FIG. 40, another embodiment of an exemplary sensor manifold is 5 shown. A subject media may be contained in or flow through cassette manifold 4000. Subject media may enter cassette manifold 4000 via pre-mokled. tube connector 4001a and exit the cassette manifold via pre-molded tube connector 4001b. Between tube connector 4001a and 4001b, there is a fluid path though the cassette (not shown). Likewise fluid paths (not shown) extend between tube connectors 4002a and 4002b and 4003a and 4003b. t o Referring again to FIG. 40, in this exemplary embodiment of cassettes that may be used in conjunction with the sensor apparatus and sensor apparatus systems described herein, the cassette includes a top plate, a midplate and a bottom plate. Fluid paths, such as the fluid path extending between tube connectors 4001a and 4001b extend through the midplate. In the exemplary embodi ment, the cassettes are formed by placing the 15 membranes in their correct locations, assembling the plates in order and laser welding the plates. The cassettes may be constructed of a variety of materials. Generally, in the various exemplary embodiment, the materials used are solid and non flexible, in the preferred embodiment, the plates are constructed of poiysulfone, but in other embodiments, the cassettes are constructed of any other solid material and in exemplary embodiment, of any 20 thermoplastic.

Referring now' to FIG. 40, in an exemplary embodiment of the cassette manifold, sensors are incorporated into the cassette so as to discern various properties of subject media contained in or flowing through the cassette, in various embodiments one sensor may be included to sense temperature and/or other properties of the subject media. In 25 another embodiment, two sensors may be included, to sense temperature and/or conductivity and/or other properties of the subject media, in yet further embodiments, three or more sensors may he included, in some embodiments, such as sensor element 4004, one sensor element of the type generally described above is included. In other embodiments, the sensors are located in the sensor block 4005. in this embodiment, a sensor block 4005 is 30 included as an area on the cassette manifold for sensor(s), such as temperature sensors and/or conductivity sensors. The conductivity sensors and temperature sensor can be any conductivity· or temperature sensor in the art. In one embodiment, the conductivity sensor elements (or sensor leads) are graphite posts. In other embodiments, the conductivity sensors elements are posts made from stainless steel, titanium, or any other material of the 42 type typically used for (or capable of being used for) conductivi ty measurements. In certain embodiments, the conductivity sensors will include an electrical connection that transmits signals from the sensor lead to a sensor mechanism, controller or other device. In various embodiments, the temperature sensor can be any of the temperature sensors commonly used 5 (or capable of being used) to sense temperature. 2016204226 22 Jun2016

However, in alternate embodiments, a combination temperature and conductivity sensor is used of the types described above. In such alternate embodiments, thermal wells of the types described above may be installed in the cassette. In such embodiments, the thermal well may be installed in the cassette by use of any of the ways described herein, to including adhesive, welding (ultrasonic and otherwise), o-ring, retaining plate, and otherwise.

Referring now' to FIG. 40, two conductivity sensors 4006 and 4007 and the temperature sensor 4008 are shown. In various embodiments, the sensors 4006,4007, and 4008 are in the fluid path (not shown) that extends between tube connectors 4002a and ! 5 4002b and 4003a and 4003b. 3.5, FLUID HANDLING SYSTEMS AND METHODS INCLUDING SENSOR APPARATUS AND SENSOR APPARA TUS SYSTEMS UTILIZED IN CONNECTION WITH A SENSOR MANIFOLD 20 In various embodiments of the inventions described herein, systems and methods for fluid handling may be utilized that comprise sensor apparatus systems comprising a sensor manifold. Examples of such embodiments may include systems and methods for the diagnosis, treatment, or amelioration of various medical conditions, including embodiments of systems and methods involving the pumping, metering, measuring, controlling, and/or 25 analysis of various bio logical fluids and/or therapeutic agents, such as various forms of dialysis, cardio bi-pass, and other types of extracorporeal treatments and therapies. Further examples include fluid treatment and preparation systems, including water treatment systems, water distillation systems, and systems for the preparation of fluids, including fluids utilized diagnosis, treatment, or amelioration of various medical conditions, such as 30 diaiysate.

Examples of embodiments of the inventions described herein may include dialysis systems and methods. More specifically, examples of embodiments of the inventions described herein may include hemodialysis systems and methods of the types described in U.S. Patent Application Serial No.l 1/871,680, tried October 12.2007 entitled Pumping 43

Cassette (Attorney Docket No, DEKA.-019XX); U.S. Patent Application entitled Hemodialysis System and Methods (Attorney Docket No. DO570/7O019USOO), filed on even date herewith; and U.S. Patent Application entitled Cassette System Integrated Apparatus (Attorney Docket No, F62), filed on even date herewith. 2016204226 22 Jun2016 5 In such systems and methods, the utilization of one or more sensor manifolds may allow subject media to be moved from one environment to another environment that is more conducive to obtain iug sensor readings. For example, the cassette manifold may be contained in an area that is less subject to various types of environment conditions, such as temperature and/or humidity, which would not be preferable for sensor apparatus such as a !0 sensing probe. Alternatively, sensing apparatus and sensing apparatus system may be delicate and may be more prone to mal functions than other components of a system. Separating the sensor apparatus and the sensor apparatus systems from other components of the system by use of a sensor manifold may allow the sensing apparatus and sensing apparatus systems to be cheeked, calibrated, repaired or replaced with minimal impact to 15 other components in the system. The ability to check, calibrate, repair or replace the sensor manifold with minimal impact to the remainder of the system may be particularly advantageous when utilized in connection with the integrated cassette systems and methods described in U.S. Patent Application entitled Hemodialysis System and Methods (Attorney Docket No, D0570/70019US00) and U.S. Patent Application entitled Cassette System 20 Integrated Apparatus (Attorney Docket No. F62), which are being filed on even date herewith. .Alternatively, the sensor manifold may fee replaced either more or less frequently than other components of the system.

With reference to FIGS. 41 - 46, various other embodiments of an exemplary sensor manifold is shown. One or more subject media, preferably a liquid in these exemplary 25 embodiments, may be contained in or flow through cassette manifold 4100 For example, one subject media may enter cassette manifold 4100 via pre-molded tube connector 4101 and exit the cassette manifold via pre-molded tube connector 4102. Between tube connector 4101 and 41.02, there is a fluid path though the cassette (best shown, as fluid path 4225 in FIG, 42). Likewise fluid paths (shown as fluid paths 4223,4220,4222,4224, and 30 4221 respectively in FIG. 42) extend between sets of tube connectors 4103 and 4104; 4105 and 4106; 4.107,4108, and 4109; 4110 and 4111; and 4112 and 4113. In certain embodiments, each fluid path may contain subject media of different composition or characteristics. In other embodiments, one or more fluid paths may contain the same or similar subject media. In certain embodiments, the same subject media may be flowed 44 through more than one flow path at the same time to check and/or calibrate the sensor apparatus systems associated with such fluid paths. 2016204226 22 Jun2016

Referring now to FIG. 43, in these exemplary embodiments of sensor manifold 4100 that may be used in conjunction with the sensor apparatus and sensor apparatus systems 5 described herein, the cassette includes a top plate 4302 and a base 4301. Fluid paths, such as the fluid path 4225 (as shown in FIG. 42) extending between tube connectors 4101 and 4102 extend between the base and top plate. The cassettes may be construc ted of a variety of materials. Generally, in the various exemplary embodiment, the materials used are solid and non flexible. In the preferred embodiment, the plates are constructed of polysulfone, 10 but in other embodiments, the cassettes are constructed of any other solid material and to exemplary embodiments, of any thermoplastic. Preferred embodiments of sensor manifold 4100 may be fabricated utilizing the systems and methods described in U S, Patent Application entitled Cassette System Integrated Apparatus (Attorney Docket No. F62), which is being filed on even date herewith. 15 Referring again to FIG. 43, in these exemplary embodiments of sensor manifolds that may be used in conjunction with the sensor apparatus and sensor apparatus systems described herein, the sensor manifold 4100 may also include printed circuit board (PCB) 4304 and a PCB cover 4305. Various embodiments may also include connector 4303 (also shown in FIGS. 41 and 44B) which may be utilized to mechanically connect the cassette 20 manifold 4100 to the system, such as a hemodialysis system. Cassette manifold 4100 may also utilize various means to hold the layers of sensor manifold 4100 together as a unit. In various embodiments, as shown in FIG. 43, connectors 4306 (also shown in FIG 44B), which in one embodiment is a screw, but in other embodiments may be any means for connection, are utilized, but any means known to one of skill in the art, such as other types 25 of screws, welds, clips, clamps, and other types of chemical and mechanical bonds may be utilized.

Referring now to FIG. 44A, in exemplary embodiments of the sensor manifold 4100, tube connectors, such as tube connector 4401, is utilized to bring subject media into or remove subject media from fluid path 4402. Sensing probes, such as sensing probe 4404 30 extending into fluid path 4402, are incorporated into sensor manifold 4100 so as to determine various properties of the subject media contained in or flowing through die particular fluid path in the sensor manifold. In various embodiments one sensing probe may be utilized to sense temperature and/or other properties of the subject media. In another embodiment, two sensing probes may be utilized to sense temperature and/or conductivity 45 and/or other properties of the subject media. In yet further embodiments, three or more sensing probes may be included, in some embodiments, one or more combination temperature and conductivity sensing probes of the types generally described herein may be utilized. In other embodiments, the conductivity sensors and temperature sensor can be any 5 conductivity or temperature sensor in the art. In one embodiment, the conductivity sensor elements for sensor leads) are graphite posts. In other embodiments, the conductivity sensors elements are posts made from stainless steel , titanium, or any other material of the type typically used for (or capable of being used for) conductivity measurements. In certain embodiments, the conductivity sensors will include an electrical connection that transmits to signals from the sensor lead to a sensor mechanism, controller or other device. In various embodiments, the temperature sensor can be any of the temperature sensors common ly used (or capable of being used) to sense temperature. 2016204226 22 Jun2016

Referring again to FIG. 44A, sensing probe 4404 is electrically connected to PCB 4405. In certain embodiments, an electrically conductive epoxy is utilized between sensor 15 element 4404 and PCB 4405 to ensure appropriate electrical connection, although other means known to those of skill in the art may be used to obtain an appropriate electrical connection between sensor element 4404 and PCB 4405. PCB 4405 is shown with edge connector 4406, In various embodiments, edge connector 4406 may be used to transmit sensor information from cassette manifold 4100 to the main system, such as embodiments 20 of the hemodialysis system described in U.S. Patent Application entitled Hemodialysis

System and Methods (Attorney Docket No. 00570/70019USOO). Edge connector 4406 may be connected to a media edge connector (such as media edge connector 4601 shown in FIG. 46). In various embodiments, media edge connector 4601 may be installed in a hemodialysis machine (not shown). In such embodiments, guide tracks 4310 and 4311 (as 25 shown in FIG. 43) may be utilized to assist in the connection of edge connector 4406 and media edge connector 4601. Various embodiments may also include connector 4303 (as shown in FIGS. 41,43 and 44B) which may be utilized to mechanically connect the cassette manifold 4100 to the system, such as a hemodialysis system.

Referring again to FIG. 44A, air trap 4410 is shown, i n certain embodiments, an air 30 trap, such as air trap 4410, may be utilized to trap and purge air in the system. As may be best shown in FIG. 42, subject media may flow through fluid path 4222 between tube connectors 4107 and 4109 in sensor manifold 4100. As the flow of the subject media is slowed around the turn in fluid path 4222 (near tube connector 4108), air may be removed from the subject media through connector 4108. 46

Referring now to FIG, 44B, PCS cover 4305 is shown, PCB cover 4305 may be connected to sensor manifold 4100 by connectors 4306. Edge connector 4406 is also 2016204226 22 Jun2016

In accordance with certain embodiments, sensor manifold 4J.00 is passive with 5 respect, to control of the fluid flow. In such embodiments, sensor manifold 4100 does not contain val ves or pumping mechanisms to control the flow of the subject media. In such embodiments, the flow of the subject media may be controlled by fluid control apparatus external to sensor manifold 4100. In other embodiments, the sensor manifold may include one or more mechanical valves, pneumatic valves or other type of valve generally used by to those of skill in the art. In such embodiments, the sensor manifold may include one or more pumping mechanisms, including pneumatic pumping mechanisms, mechanical pumping mechanisms, or other type of pumping mechanisms generally used by those of skill in the art. Examples of such valves and pumping mechanisms may include the valves and pumping mechanisms described in .U.S. Patent Application Serial No.11/871,680, filed 15 October 12, 2007 entitled Pumping Cassette (Attorney Docket No. DEKA-019XX); U .S. Patent Application entitled Hemodialysis System and Methods (Attorney Docket No. D057O/7OGf 9US00), filed on even date herewith; and U.S. Patent Application entitled Cassette System Integrated Apparatus {Attorney Docket No, F62), filed on even date herewith. 20 Referring now to FIG. 45, tube connector 4401. is shown in base 4301. Top plate 4302 is shown, along with connector 4303. Sensing probes, such as sensing probe 4501, extend through top plate 4302 into fluid path 4503. Sensing probe 4501 may be various types of sensors, including the embodiments of sensing probes generally shown in FIGS. 8 and 9 herein. 25 The sensing probes, such as sensing probe 4501, may be all die same, may be individually selected from various sensors based on the type of function to be performed, or the same probe may be individually modified based on the type of function to he performed. S imilarly, the configuration of the fl uid paths, such as t he length of the fluid path and the shape of the fluid path, may be selected based on the function to be performed. By way of 30 example, to detect the temperature of the subject media in a fluid path, a temperature sensor, such as a thermistor, may be used. Again, by way of example, to measure the conducti vity of the subject media, one sensing probe configured to measure temperature and conductivity, such as sensing probes of the type generally shown in FIGS, 8 and 9, and one sensing probe configured only to measure conductivity may be utilized, in other 47 embodiments, two or more sensing probes configured, to measure both temperature and conducti vity, such as sensing probes of the type generally shown in FIGS. 8 and 9, may be utilized. In various embodiments of such configurations, by way of example, the second temperature sensor may be present but not utilized in normal operation, or the second 5 temperature may be utilized for redundant temperature measurements, or the or the second temperature may be utilized for redundant temperature measurements. 2016204226 22 Jun2016

Referring again to FIG. 45, PCB 4562 is shown with electrical connection 4503. As farther shown in FIG. 46, FOB 4602 is shown with electrical connection 4603 for connection to a sensing probe (shown as 4501 in FIG. 45). FOB 4602 also contains opening 10 4604 for attachment to top plate (shown as 4305 in FIG. 45). In certain embodiments, electrical connection 4603 is mounted onto, or manufactured with, PCB 4602 with air gap 4606. In such embodiments, air gap 4606 may be utilized to provide protection to the electrical connection between sensing probe 4501 and PCB 4602 by allowing shrinking and expansion of the various components of sensor manifold 4100 with lesser impact to PCB 15 4602.

Referring again to FIG. 46, PCB 4602 is also shown with edge connector 4605. As described herein, edge connector 4605 may interface with edge connector receiver 4601, which may be connected to the system, such as the hemodialysis system, to which sensor manifold 4100 interfaces. 20 Various embodiments of exemplar}' sensor manifold 4100 shown in FIG. 41 -46 may be utilized in conjunction with hemodialysis systems and methods desscribed in U.S, Patent Application Serial No. 11/871.,680, filed October .12,2007 entitled Pumping Cassette (Attorney Docket No. DEKA-019XX); U.S, Patent Application entitled Hemodialysis System and Methods (Attorney Docket No. D0570/70019US00), filed on even date 25 herewith; and U.S. Patent Application entitled Cassette System Integrated Apparatus (Attorney Docket No. F62), filed on even date herewith. In certain embodiments, sensor manifold 4100 contains all of the temperature and conducti vity sensors shown in FIG. 47. FIG. 47 depicts a fluid schematic in accordance with one embodiment of the inventions described in the patent applications reference above. 30 By way of example, in various embodiments, the temperature and conductivity of the subject media at position 4701 as shown in FIG. 47 may be determined utilizing sensor manifold 4100. In such embodiments, subject media flows into tube connector 4105 (as shown in FIG. 41) through fluid path 4220 (as shown in FIG. 42) and exits at tube connector 4106 (as shown in FIG. 41). The conductivity of the subject media is measured 48 by t wo sensing probes (not shown) extending into fluid path 4220, at least one of which has been configured to include a temperature sensing element, such as a thermistor. T he conductivity measurement or the temperature measurement of the subject media may be utilized to determine and/or correlate a variety of information of utility to the hemodialy sis 5 system. For example, in various embodiments at position 4701 in FIG, 47, the subject media may be comprised of water to which a bicarbinated based solution has been added. Conductivity of the subject media at position 4701 may be utilized to determine if the appropriate amount of the bicarbona te based solution has been added prior to position 4701. In certain embodiments, if the conductivity measurement deviates from a predetermined 10 range or deviates from a predetermined measurement by more than a predetermined amount, then the subject media may not contain the appropriate concentration of the bicarbonate based solution. In such instances, in certain embodiments, the hemodialysis system may be alerted. 2016204226 22 Jun2016

Again, by way of example, in various embodiments, the conductivity of the subjec t 15 media at position 4702 as shown in FIG. 47 may be determined utilizing sensor manifold 4100. In such embodiments, subject media flows into tube connector 4112 (as shown in FIG, 41) through fluid path 4221 (as shown in FIG. 42) and exits at tube connector 4113 (as shown in FIG. 41). T he conductivity of the subject media is measured by two sensing probes (not shown) extending into fluid path 4221, at least one of which has been 20 configured to include a temperature sensing element, such as a thermistor. The conductivity measurement or the temperature measurement of the subject media may be utilized to determine and/or correlate a variety of information of utility to the hemodialysis system.

For example, in various embodiments at position 4702 in FIG. 47, the subject media may be comprised of water to which a bicarbinated based solution and then an acid based solution 25 has been added. Conductivity of the sub ject media at position 4702 may be utilized to determine if the appropriate amount of the acid based solution (and the bicarbonate based solution in a previous step) has been added prior to position 4702. In certain embodiments, if the conductivity measurement deviates from a predetermined range or deviates from a predetermined measurement by more than a predetermined amount, then the subject media 30 may not contain the appropriate concentration of the acid based solution and the bicarbonate based solution. In such instances, in certain embodiments, the hemodialysis system may be alerted.

By way of further example, in various embodimen ts, the temperature and conductivity of the subject media at position 4703 as shown in FIG. 47 may be determined 49 utilizing sensor manifold 4100. In such embodiments, subject media may flow into or out of tube connector 4107 (as shown In FIG. 41) through fluid path 4222 (as shown in FIG. 42) and may flow into or out of tube connector 4109 (as shown in FIG. 41). As described herein, air may be removed from the subject media as it moves past the turn in fluid path 5 4222. In such instances, a portion of the subject media may be removed through tube 2016204226 22 Jun2016 connector 4108 to the drain, bringing with it air from the air trap. The conductivity of the subject media is measured by two sensing probes (not shown) extending into fluid path 4222, at least one of which has been configured to include a temperature sensing element, such as a thermistor. T he conductivity measurement or the temperature measurement of the to subject media may be utilized to determine and/or cone late a variety of information of utility to the hemodialysis system. For example, in various embodiments, the conductivity measurement at position 4703 in FIG. 47 may be utilized to correlate to the clearance of the dialyzer. In such instances, in certain embodiments, this information may then be sent to the hemodialysis system. 15 Again, by way of further example, in various embodiments, the temperature of the subject media at position 4704 as shown in FIG. 47 may he determined utilizing sensor manifold 4100, in such embodiments, subject media flows into tube connector 4103 (as shown in FIG. 41) through fluid path 4223 (as shown in FIG. 42) and exits at tube connector 4104 (as shown in FIG . 41). The temperature of the subject media is measured 20 by one or more sensing probes (not shown) extending into fluid path 4223. The temperature measurement of the subject media at position 4704 may be utilized to determine and/or correlate a variety of information of utility to the hemodialysis system. For example, in various embodiments at position 4704 in FIG. 47, the temperature of the subject media is determined down stream of a heating apparatus 4706. If the temperature deviates from a 25 predetermined range or deviates from a predetermined measurement by more than a predetermined amount, then the hemodialysis system may be alerted. For example in certain embodiments, the subject media may be re-circulated through the heating apparatus 4706 until the temperature of the subject media is within a predetermined range.

Again, by way of further example, in various embodiments, the temerparure and 30 conductivity of the subject media at position 4705 as shown in FIG. 47 may be determined utilizing sensor manifold 4100. In such embodiments, subject media flows into tube connector 41.10 (as shown in FIG. 41) through fluid path 4224 (as shown in FIG. 42) and exits at tube connector 4111 (as shown in FIG. 41), The conductivity of the subject media is measured by two sensing probes (not shown) extending into fluid path 4224, at least one 50 of which has been configured to include a temperature sensing element, such as a thermistor. The conducti vity measurement or the temperature measurement of the subject media may be util ized to determine and/or correlate a variety of information of utility to the hemodialysis system. For example, the temperature and conductivity measurement at 5 position 4705 may be used as a further safety check to determine if the temperature, 2016204226 22 Jun2016 conductivity, and, by correlation, the composition of, the subject media is within acceptable ranges prior to the subject media reaching the dialyzer 4707 and, thus, the patient. In certain embodiments, if the temperature and/or conductivity measurement deviates from a predetermined range or deviates .from a predetermined measurement by more than a to predetermined amount, then the hemodialysis system may be alerted.

For the various embodiments described herein, the cassette maybe made of any material, including plastic and metal. The plastic may be flexible plastic, rigid plastic, semi-flexible plastic, semi-rigid plastic, or a combination of any of these. In some of these embodiments the cassette includes one or more thermal wells. In some embodiments one or 15 more sensing probes and/or one or more other devices for transferring information regarding one or more characteristics of suc h subject media are in direct contact with the subject media. In some embodiments, the cassette is designed to hold fluid having a flow rate or pressure, in other embodiments, one or more compartments of the cassette is designed to hold mostly stagnant media or media held in the conduit even if the media has 20 flow.

In some embodiments, the sensor apparatus may be used based on a need to separate the subject media from the sensing probe. However, in other embodiments, the sensing probe is used for temperature, conductivity, and/or other sensing directly with subject media. 25 Although the above discussion discloses various exemplary embodi ments of the invention, it should be apparent that those skilled in the art can make various modifications that will achieve some of the advantages of the invention without departing from the true scope of the invention. While the pri nciples of the invention have been described herein, it is to be understood by those skilled in the art that this description is made only by way of 30 example and not as a limitation as to the scope of the invention. Oilier embodiments are contemplated within the scope of the present invention in addition to the exemplary embodiments shown and described herein. Modifications and substitutions by one of ordinary skill in the art are considered to be within the scope of the present invention. 51 2016204226 22 Jun2016

Throughout this specification and the claims which follow, unless the context requires otherwise, the word "comprise", and variations such as "comprises" and "comprising", will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps. 5 The reference to any prior art in this specification is not, and should not be taken as, an acknowledgement or any form of suggestion that the prior art forms part of the common general knowledge in Australia. 52

Claims

Claims

1. A dialysis apparatus comprising a cassette for sensing liquid in the dialysis apparatus, the cassette comprising a housing having a plurality of fluid paths, each fluid path including a sensor element comprising a well for transmitting temperature and permitting conductivity sensing of fluid passing along the fluid path, wherein the well is adapted for interconnection with a sensor, wherein a first fluid path of the housing is configured to receive a first mixture of water and a bicarbonate buffer solution, and a second fluid path of the housing is configured to receive a second mixture of completed dialysate comprising the first mixture and an acid or electrolyte concentrate; wherein each fluid path comprises a conductivity sensing probe extending into the fluid path and spaced apart from the well.
2. The dialysis apparatus of claim 1, wherein each sensor is mounted onto and electrically connected with a printed circuit board having an edge connector through which sensor information may be transmitted from the sensors to a system controller.
3. The dialysis apparatus of claim 1, wherein the housing comprises a top plate and a base, the top plate being sealingly engaged with the base to define the volumes of the fluid paths, wherein sensor elements of each sensor penetrate the top plate to extend into the fluid paths.
4. The dialysis apparatus of claim 1, wherein the well is configured to make contact with fluid in the fluid path.
5. The dialysis apparatus of claim 4, wherein the well is coupled to the cassette using at least one of press fit connection, flexible tabs, adhesive, ultrasonic weld, and a retaining plate and fastener.
6. The dialysis apparatus of claim 1, wherein the sensor is a thermistor.
7. The dialysis apparatus of claim 1, wherein said well comprises a hollow housing of a thermally and electrically conductive material, said housing having an outer surface and an inner surface, said inner surface of a predetermined shape so as to form a mating relationship with a sensing probe, wherein said mating thermally and electrically couples the inner surface with the sensing probe.
8. The dialysis apparatus of claim 1, wherein each fluid path comprises a conductivity sensing probe extending into the fluid path and spaced apart from the well.
9. A dialysis apparatus comprising a cassette for sensing liquid in the dialysis apparatus, the cassette comprising a housing having a plurality of fluid paths, each fluid path including a sensor element comprising a well for transmitting temperature and permitting conductivity sensing of fluid passing along the fluid path, wherein the well is adapted for interconnection with a sensor, wherein a first fluid flow path of the housing is configured to receive a liquid via a first port and to expel the liquid via a second port located vertically above the first port, and wherein a third port above the first and second ports is arranged to vent gas that escapes from the liquid moving from the first port to the second port.
10. A dialysis apparatus comprising a cassette for sensing liquid in the dialysis apparatus, the cassette comprising a housing having a plurality of fluid paths, each fluid path including a sensor element comprising a well for transmitting temperature and permitting conductivity sensing of fluid passing along the fluid path, wherein a first fluid flow path of the housing is configured to receive dialysate solution that is flowing to a dialyzer, and a second fluid flow path of the housing is configured to receive dialysate solution directed to drain or to a heating apparatus; wherein each well of the plurality of fluid paths is adapted for interconnection with a thermistor.
11. The dialysis apparatus of claim 10, wherein the plurality of fluid paths each further comprises a conductivity sensing probe extending into the fluid path.