Measuring chemical properties of a sample fluid in dialysis systems
09599599 ยท 2017-03-21
Assignee
Inventors
- Stephen R. Ash (Lafayette, IN)
- Thomas A. Sullivan (Pine Village, IN, US)
- David Carr (West Lafayette, IN, US)
- Michael James Beiriger (Pittsburgh, PA, US)
Cpc classification
A61M2230/202
HUMAN NECESSITIES
Y10T436/171538
GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
Y10T436/117497
GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
Y10T436/175383
GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
Y10T436/204998
GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
A61M1/305
HUMAN NECESSITIES
International classification
G01N33/00
PHYSICS
A61M1/36
HUMAN NECESSITIES
A61M1/30
HUMAN NECESSITIES
Abstract
In one aspect of the invention, a method includes determining an amount of carbon dioxide (CO.sub.2) in dialysate flowing through a dialysis system using a CO.sub.2 sensor associated with the dialysis system, determining, using a pH sensor associated with the dialysis system, a pH level of the dialysate, and calculating a level of bicarbonate in the dialysate based at least in part on the determined amount of CO.sub.2 measured in the gas and the determined pH level of the dialysate.
Claims
1. A method comprising: causing dialysate to flow into a chamber having a gas-permeable membrane and a material that is configured to alter an appearance of the material based at least in part on a pH level of the dialysate, wherein the chamber is removably attached to a hemodialysis machine having: a CO.sub.2 sensor, a pH sensor, and a dialyzer, determining an amount of carbon dioxide in the dialysate using the CO.sub.2 sensor determining a pH level of the dialysate using the pH sensor; calculating a level of bicarbonate in the dialysate based at least in part on the determined amount of CO.sub.2 in the dialysate and the determined pH level of the dialysate; and causing bicarbonate to flow into the dialysate based at least in part on the calculated level of bicarbonate.
2. The method of claim 1 further comprising causing the dialysate to flow through the dialyzer after exiting the chamber.
3. The method of claim 2 further comprising determining an infusion amount of replacement substance based at least in part on the on the calculated level of bicarbonate.
4. The method of claim 1 further comprising causing the dialysate to flow from the dialyzer to the chamber.
5. The method of claim 1 wherein the membrane is configured to prevent liquid from passing through the membrane.
6. The method of claim 1 wherein the CO.sub.2 sensor comprises an infrared sensor.
7. The method of claim 1 further comprising causing the dialysate to contact the material.
8. The method of claim 1 wherein the material is configured to alter a color of the material based at least in part on the pH level of the dialysate.
9. The method of claim 1 wherein the material comprises a pH strip.
10. The method of claim 1 wherein the material comprises a sol-gel.
11. The method of claim 1 further comprising using the pH sensor to detect the alteration in the appearance of the material.
12. The method of claim 11 further comprising causing one or more artificial light sources to direct light toward the material such that the material reflects at least a portion of the directed light.
13. The method of claim 12, further comprising using the pH sensor to detect at least a portion of light reflected by the material.
14. The method of claim 1, wherein an amount of CO.sub.2 is emitted from the dialysate, and wherein determining the amount of CO.sub.2 in the dialysate comprises measuring the amount of CO.sub.2 emitted from the dialysate.
15. The method of claim 1, wherein an amount of CO.sub.2 is emitted from the dialysate, and wherein determining the amount of CO.sub.2 in the dialysate comprises determining a partial pressure of CO.sub.2 associated with a gas emitted by the dialysate.
16. A method comprising causing dialysate to flow into a chamber having a gas-permeable membrane and a material that is configured to alter an appearance of the material based at least in part on a pH level of the dialysate, wherein the chamber is removably attached to a hemodialysis machine having: a CO.sub.2 sensor, a pH sensor, and a dialyzer, the chamber being positioned upstream of the dialyzer; determining an amount of carbon dioxide in the dialysate using the CO.sub.2 sensor determining a pH level of the dialysate using the pH sensor; calculating a level of bicarbonate in the dialysate based at least in part on the determined amount of CO.sub.2 in the dialysate and the determined pH level of the dialysate; and determining a toxin removal efficiency based at least in part on the calculated bicarbonate level.
17. The method of claim 16 further comprising determining an infusion amount of replacement substance based at least in part on the toxin removal efficiency; and causing the replacement substance to flow into the dialysate.
18. The method of claim 17 wherein the replacement substance is bicarbonate.
19. The method of claim 16 wherein the membrane is configured to prevent liquid from passing through the membrane.
20. The method of claim 16 further comprising using the pH sensor to detect the alteration in the appearance of the material.
21. A method comprising: causing dialysate to flow into a first chamber positioned upstream from a dialyzer of a hemodialysis machine, the hemodialysis machine also having a CO.sub.2 sensor and a pH sensor, the chamber having a gas-permeable membrane and a material that is configured to alter an appearance of the material based at least in part on a pH level of the dialysate, wherein the first chamber is removably attached to the hemodialysis machine; determining a first amount of carbon dioxide in the dialysate using the CO.sub.2 sensor determining a first pH level of the dialysate using the pH sensor; calculating a first level of bicarbonate in the dialysate based at least in part on the determined amount of CO.sub.2 in the dialysate and the determined pH level of the dialysate; causing dialysate to flow into a second chamber having a gas-permeable membrane and a material that is configured to alter an appearance of the material based at least in part on the pH level of the dialysate, wherein the second chamber is removably attached to the hemodialysis machine downstream from the dialyzer; determining an second amount of carbon dioxide in the dialysate using the CO.sub.2 sensor; determining a second pH level of the dialysate using the pH sensor; and calculating a second level of bicarbonate in the dialysate based at least in part on the determined amount of CO.sub.2 in the dialysate and the determined pH level of the dialysate.
22. The method of claim 21 further comprising determining a patient disturbance of the bicarbonate levels of the dialysate based at least in part on comparing the first bicarbonate level to the second bicarbonate.
23. The method of claim 22 further comprising causing bicarbonate to flow into the dialysate based at least in part on the patient disturbance.
24. The method of claim 21 wherein the gas-permeable membranes are configured to prevent liquid from passing through the membrane.
25. The method of claim 21 further comprising using the pH sensor to detect the alteration in the appearance of the material.
Description
DESCRIPTION OF DRAWINGS
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DETAILED DESCRIPTION
(10)
(11) Certain desired substances (e.g., magnesium, calcium, potassium, and sodium) may be stripped from the dialysate as the dialysate passes through the sorbent device 120. Those stripped substances can be added to the dialysate exiting the sorbent device 120 (e.g., prior to drawing the dialysate into the bicarbonate measurement unit 125). As shown in
(12) As shown in
(13) The sodium concentration of the dialysate passing through the dialyzer 135 affects (e.g., increases or decreases) the sodium concentration in the patient's blood. If the sodium concentration in the patient's blood falls outside a desired range, the patient may experience discomfort or illness. For this reason, a conductivity meter may be positioned within the module 105 to measure the conductivity of dialysate after the dialysate exits the sorbent device 120. These conductivity readings can be used during treatment to determine the amount of sodium chloride solution or dilution water to be added to the recycled dialysate exiting the sorbent device 120. In particular, because the sodium in the dialysate is the predominant contributor to the conductivity of the dialysate, the sodium concentration of the dialysate can be determined or approximated based on the conductivity readings. The amount of sodium chloride solution or dilution water to add to the dialysate in order to achieve a desired sodium concentration within the dialysate can then be determined.
(14) In addition to the manifolds 130 and 140, the module 105 includes a manifold 175 to which fluid lines 177, 179 extending from the bag 180 are connected and a manifold 185 to which fluid lines 187, 189 extending from an ammonium (NH4) sensor 190 are connected. The module 105 further includes a manifold 200 by which a fresh dialysate container 202 and a drain container 203 are connected to the module 105 via a fluid line 204 and a drain line 205, respectively. Each of manifolds 130, 140, 175, 185, and 200 can, for example, include projections on which fluid lines can be positioned to connect the various components described above to their respective manifold. Any of various other suitable connection mechanisms can alternatively or additionally be used to connect the fluid lines to the manifolds.
(15) The manifold 175 allows dialysate to be transferred from the module 105 to the bag 180 and vice versa. In particular, using pumps and valves within the module 105, dialysate can be pumped into and suctioned out of the bag 180 via the fluid lines 177, 179 connected to the manifold 175. The manifold 185 permits dialysate to be transferred from the module 105 to the ammonium sensor 190 and vice versa. By activating pumps and valves within the module 105 in a desired manner, the dialysate can be pumped from the module 105 to the ammonium sensor 190 and can be drawn back to the module 105 from the ammonium sensor 190. By activating pumps and valves within the module, fluid can be drawn into the module 105 from the fresh dialysate container 202 via the fluid line 204, and fluid can be pumped from the module 105 to the drain container 203 via the drain line 205. With the sorbent device 120 positioned in the cartridge holder 115, as shown in
(16) Still referring to
(17) As the blood is pumped through the various blood lines and components of the blood component set 225, it may be desirable to inject certain substances, such as drugs and/or saline into the blood lines. As shown in
(18) In some examples, it is useful to measure an amount of bicarbonate in dialysate while dialysis is being performed on a patient. In some sorbent-based dialysis systems, a bicarbonate concentration of the dialysate is established by the concentration of the fresh dialysate, and by the donation of bicarbonate from the sorbent device 120 (or other sources, such as the bicarbonate container 192) during treatment. The bicarbonate in the premix is circulated through the sorbent device where some of the bicarbonate is broken down due to the acidity of the sorbent device 120. Additional bicarbonate is donated to the dialysate due to the breakdown of a patient's urea in the sorbent device 120. These factors complicate calculating or setting a fixed bicarbonate concentration for the dialysate. Accordingly, it can be useful to measure the bicarbonate concentration of the dialysate during treatment so that a bicarbonate concentration can be maintained during treatment that is appropriate for the patient.
(19) One technique for determining the bicarbonate concentration of a fluid such as dialysate is defined by the Henderson-Hasselbach equation. The Henderson-Hasselbach equation relates the bicarbonate concentration of a fluid with the acidity (pH) of the fluid and the partial pressure of carbon dioxide (CO2) of the fluid. The Henderson-Hasselbach equation is:
(20)
Thus, if two of the constituent concentrations of dialysate can be determined (e.g., the pH level and the partial pressure of CO2), the third concentration (e.g., the bicarbonate concentration) can be calculated based on the known values.
(21)
(22) As the dialysate passes through the sorbent device 120, certain substances, such as calcium, magnesium, potassium, and sodium may be stripped from the dialysate. As discussed above, the sorbent device 120 is also adapted to remove toxins, such as urea, from fluid flowing therethrough, but while the fresh dialysate from the fresh dialysate container 202 would generally not contain any such toxins, it would have some capacity to purify dialysate, allowing, for example, tap water to be used as dialysate.
(23) The infusate solution, which includes magnesium, calcium, and potassium, is then pumped into the fluid outlet line 275 from the infusate solution container 136 by activating a pump 244. As discussed above, the infusate solution can be added to the dialysate to restore concentrations of magnesium, calcium, and potassium to desired levels. Maintaining the concentration of these substances within the dialysis solution, such as calcium, magnesium, potassium, and sodium, can help to prevent the patient from experiencing discomfort during and after the treatment.
(24) After introducing the infusate solution into the dialysate, the mixture of the dialysate and infusate solution continues to flow through the fluid outlet line 275 and passes through the conductivity meter 145. The conductivity meter 145 can estimate, based on the conductivity of the dialysate passing therethrough, the concentration of sodium within the dialysate. A pump 246 can then be activated in a manner to introduce sodium chloride solution into the fluid outlet line 275 from the sodium chloride solution container 138 if the conductivity reading indicates that the sodium level in the dialysate is lower than desired. The pump 246 can be operated in a manner to meter a desired volume of sodium chloride solution into the dialysate at a desired rate.
(25) Similarly, a pump internal to the hemodialysis machine 110 can be activated to inject dilution water (e.g., tap water) from the dilution water container 141 into the dialysate exiting the hemodialysis machine 110 and entering the module 105 if the conductivity reading indicates that the sodium level in the dialysate is higher than desired. This dilution water pump can be operated in a manner to meter a desired volume of the dilution water into the dialysate at a desired flow rate.
(26) A microprocessor (which may include the previously mentioned control unit or a different processing device) is connected to the flow meter 242, the conductivity meter 145, and the pumps 241, 244, 246, 256 and 276. The microprocessor is also connected to the dilution water pump inside the hemodialysis machine 110. The measured flow rate of the dialysate is transmitted in the form of a signal from the flow meter 242 to the microprocessor. The microprocessor adjusts operation of the pumps 241 and 256 based on the measured flow rate at the flow meter 242 to ensure that a prescribed dialysate flow rate is achieved. The microprocessor also controls the pump 244 as a function of the flow rate of the dialysate measured by the flow meter 242. This arrangement helps to ensure that a desired amount of the infusate is added to the dialysate, and thus helps to ensure a desired proportion of the infusate to the dialysate.
(27) In response to receiving the signals from the conductivity meter 145, the microprocessor sends signals to the pumps 244 and 246 to cause some of the sodium chloride solution, if desired, to be introduced into the fluid outlet line 275. Similarly, in response to receiving these signals from the conductivity meter 145, the microprocessor can cause the dilution water pump in the hemodialysis machine 110 to pump dilution water, if desired, into the dialysate exiting the hemodialysis machine 110 and entering the module 105. As a result, the amount of sodium chloride and/or dilution water delivered to the dialysate can better achieve a desired sodium concentration within the dialysate (e.g., a sodium concentration that closely matches the sodium concentration prescribed by the dialysis patient's physician).
(28) After passing through the conductivity meter 145, the dialysate passes through a check valve 254 and into the ammonium sensor 190, which detects ammonium levels within the dialysate.
(29) After filling the bag 180 to a desired level with dialysate having a desired concentration of calcium, magnesium, potassium, and sodium, a pump 256 is activated to draw the dialysate from the bag 180 into the hemodialysis machine 110 via fluid line 257. Before entering the hemodialysis machine 110, the dialysate may be caused to flow (e.g., upon the activation of one or more valves) into the dialysate collection unit 300 via the inlet line 132. The amount of bicarbonate in the dialysate is measured by the bicarbonate measurement unit 125 while the dialysate flows through the dialysate collection unit 300 (e.g., using the techniques described below), and is returned to the fluid line 257 via the outline line 134.
(30) Based on the amount of bicarbonate measured in the dialysate by the bicarbonate measurement unit 125, bicarbonate can be added to the dialysate from the bicarbonate container 191. For example, a pump 276 can be activated which draws bicarbonate into the fluid line 275 via a bicarbonate fluid line 192 from the bicarbonate container 191. Drawing bicarbonate into the fluid line 275 will alter the bicarbonate level of the dialysate, and can be continuously measured by the bicarbonate measurement unit 125 and adjusted until the desired level of bicarbonate is reached (e.g., a level of bicarbonate that is appropriate for a patient).
(31) The dialysate is circulated through the hemodialysis machine 110 and passes through the dialyzer 135 connected to the hemodialysis machine 110. At the same time, a patient's blood is circulated through the blood component set 225, including the dialyzer 135, connected to the hemodialysis machine 110. As a result, toxins, such as urea, are transferred across a permeable membrane (e.g., permeable microtubes) of the dialyzer 135 from the patient's blood to the dialysate. The spent dialysate exiting the dialyzer 135 is then routed back to the module 105.
(32) The spent dialysate passes through a fluid line 258 in the module 105. Depending on the desired volume of dialysate to be cycled back to the dialysis machine, some of the spent dialysate can be routed to a spent dialysate chamber of the bag 180 via open valve 260 while the remainder of spent dialysate is routed toward the sorbent device via open valve 262. As a result of the dialysis, for example, fluid from the patient may be added to the dialysate as the dialysate passes through the dialyzer 135. Thus, routing some of the spent dialysate to the bag 180 can help to ensure that a substantially constant volume of dialysate is circulated through the module 105 and/or the hemodialysis machine 110 throughout treatment. The pump 241 along the fluid line 258 forces the volume of the spent dialysate that is not routed to the bag 180 into the sorbent device 120 via the cartridge holder 115. As the spent dialysate passes through the sorbent device 120, urea is removed from the spent dialysate. Calcium, magnesium, and potassium are also stripped from the spent dialysate by the sorbent device 120.
(33) In the manner discussed above, after the recycled dialysate exits the sorbent device 120, the infusate solution is introduced into the recycled dialysate and, based on the conductivity reading at the conductivity meter 145, sodium chloride may be added to the recycled dialysate. Similarly, dilution water can be added to the spent dialysate exiting the hemodialysis machine 110 and entering the module 105 based on the reading at the conductivity meter 145. In the initial stages of treatment, sodium levels in the recycled dialysate tend to be lower than desired due to the tendency of the sorbent device 120 to strip sodium from the dialysate passing therethrough. Consequently, in the early stages of the treatment, sodium chloride will typically be injected into a fluid line to increase the concentration of sodium in the recycled dialysate. In later stages of the treatment, however, the sorbent device 120 may contain high levels of sodium and thus release sodium into the spent dialysate as the spent dialysate passes through the sorbent device 120. This can lead to higher than desired levels of sodium in the recycled dialysate passing through the fluid outlet line 134. In such cases, dilution water is injected into the spent dialysate exiting the hemodialysis machine 110 and entering the module 105 to lower the sodium concentration of the spent dialysate. This spent dialysate then travels through the module 105 to the sorbent device 120 where the dilution water and spent dialysate are filtered.
(34) Injecting the dilution water into the spent dialysate before the spent dialysate passes through the sorbent device 120 to be filtered allows the use of tap water as the dilution water because the tap water will be filtered and purified as it passes through the sorbent device 120. This arrangement permits the hemodialysis system 100 to be operated with a readily available supply of dilution water and without the need for storing large volumes of dilution water on site.
(35) After flowing past the conductivity meter 145, the recycled dialysate passes through the check valve 254 and into the ammonium sensor 190. After exiting the ammonium sensor 190, some of the recycled dialysate is routed to the bag 180 and some of the recycled dialysate is routed to the hemodialysis machine 110. The dialysate may again enter the bicarbonate measurement unit 125 via the inlet line 132 and a valve if further monitoring of the dialysate's bicarbonate level is desired. The measurements provided by the bicarbonate measurement unit 125 can be used to further alter the bicarbonate level of the dialysate (e.g., by introducing additional bicarbonate from the bicarbonate container 191 into the dialysate).
(36) In order to ensure that an equal amount of fluid enters and exits the hemodialysis machine 110, a T-valve 264 is adapted to route a portion of the dialysate to the hemodialysis machine 110 via the fluid line 257 and to route excess dialysate to the fresh dialysate chamber of the bag 180. Because the flow rate of the dialysate at the T-valve 264 is generally greater than the rate at which the dialysate is being pulled into the hemodialysis machine 110, there will typically be excess dialysate passing through the T-valve 264 and that excess dialysate will be routed to the bag 180 where it is collected for later use.
(37) The dialysate that is delivered to the hemodialysis machine 110 again passes through the dialyzer where toxins are transferred from the patient's blood to the dialysate. The spent dialysate is then routed back to the module and the process is repeated until a desired amount of toxins has been removed from the patient's blood.
(38) After completing the patient's treatment, the dialysate can be removed from the bag 180. For example, the pumps and valves of the module 105 can be operated in a manner to pump the dialysate from the bag 180 into the drain container 203 or into a plumbing drain. Emptying the bag 180 can allow the user to more easily handle the bag 180 after treatment due to the decreased weight.
(39) After draining the bag 180 to a desired level, the external components (e.g., the sorbent device 120, the infusate container 136, the bicarbonate measurement device 125, the sodium chloride container 138, the bicarbonate container 192, the bag 180, the dialysate container 202, the drain container 203, and their associated fluid lines), which are constructed as disposable, single use components, are disconnected from the module 105 and discarded.
(40) Referring to
(41) The dialysate collection unit 300 includes a main body that is in fluid communication with the inlet line 132 that carries dialysate. In general, the main body of the dialysate collection unit 300 defines a chamber which is adapted to receive dialysate from the inlet line 132. The main body is also in fluid communication with the outlet line 134 that routes the dialysate back into the module 105. The inlet line 132 and the outlet line 134 may be detachably connected to the dialysate collection unit 300. In some examples, the main body is a cuvette (e.g., a tube of circular or square cross section, made of plastic, glass, or fused quartz, that is designed to hold samples, especially for spectroscopic experiments).
(42) A surface 303 of the main body of the dialysate collection unit 300 defines an opening 305. The opening 305 is covered by a gas-permeable membrane 311, such that dialysate flowing through the dialysate collection unit 300 will flow over (but not through) both the opening 305 and the gas-permeable membrane 311. In some examples, the gas-permeable membrane 311 is a breathable, waterproof fabric, such as Gor-Tex. The main body of the dialysate collection unit 300 also includes one or more surfaces (e.g., surface 303) to which a pH-reactive material 309 has been applied in such a way that dialysate flowing through the dialysate collection unit 300 will contact the pH-reactive material 309. As described in further detail below, when the pH-reactive material 309 and the gas-permeable membrane 311 are aligned with appropriate sensors (e.g., sensors located on the module 105), the bicarbonate measurement unit 125 can be used to measure the amount of bicarbonate in dialysate flowing through the main body of the dialysate collection unit 300 without contacting the liquid dialysate with sensors or probes.
(43) The main body of the dialysate collection unit 300 is configured to receive a flow of dialysate via the inlet line 132 and may partially or completely fill with dialysate. With dialysate flowing on one side of the gas-permeable membrane, gas emitted from the dialysate will pass through the gas-permeable membrane 311, and can be detected and analyzed by one or more sensors as described below. Thus, dialysate flows into the dialysate collection unit 300 via inlet line 132 and fills at least a portion of the main body and exits the main body via the outlet line 134. While the dialysate is in the main body of the dialysate collection unit 300, the pH-reactive material 309 and the gas-permeable membrane 311 can be used to determine the pH level and the partial pressure of CO.sub.2 of the dialysate, respectively. Examples of techniques and devices used to calculate the pH level and partial pressure of CO.sub.2 of the dialysate using, for example, the arrangement of
(44)
(45) As described above, when dialysate flows through the main body of the dialysate collection unit 300, gas emitted from the dialysate is transferred through the gas-permeable membrane 311. The gas emitted from the dialysate is transferred into a gas collection chamber 405 of the CO.sub.2 sensor 403, and may include both CO.sub.2 gas as well as other gases. After the gas has passed through the gas-permeable membrane 311 and has entered the gas collection chamber associated with the CO.sub.2 sensor 403, the CO.sub.2 sensor 403 can measure the concentration of CO.sub.2 gas present in the gas collected in the gas collection chamber 405. In some examples, the gas collection chamber forms a seal with the gas-permeable membrane 311 and/or a surface of the dialysate collection unit 300 such that most or all of the gas that has permeated the gas-permeable membrane 311 passes directly into the gas collection chamber 405 of the CO.sub.2 sensor 403.
(46) In some examples, the CO.sub.2 sensor 403 is an infrared gas sensor configured to detect an amount of CO.sub.2 in a fluid, such as the gas collected in gas collection chamber 405. The CO.sub.2 sensor 403 may include an infrared source (e.g., a lamp or laser), a wavelength filter, and an infrared detector. When the CO.sub.2 gas enters the CO.sub.2 measurement chamber, the gas concentration can be measured electro-optically by the gas's absorption of a specific wavelength in the infrared (IR). The IR light is directed through the gas collection chamber 405 a detector associated with the CO.sub.2 sensor. The IR light can also be reflected back toward a detector; that is, the detector does not necessarily need to be positioned opposite the IR source. The detector may include an optical filter that eliminates all light except the wavelength that the selected gas molecules can absorb, which allows the detector to measure the absorption of the characteristic wavelength of light absorbed by the CO.sub.2 gas in the gas collection chamber 405. The CO.sub.2 sensor 403 can then use the collected information to determine the concentration of CO.sub.2 in the gas collection chamber 405. The IR signal from the IR source can be chopped or modulated so that thermal background signals can be offset from the desired signal.
(47) According to Henry's law, the partial pressure of free CO.sub.2 in a gas in equilibrium with (e.g., above) the dialysate is proportional to the dissolved CO.sub.2 in the dialysate. That is, Henry's law describes the equilibrium between a vapor and a liquid. At a constant temperature, Henry's law states:
p=k.sub.Hc,
where p is the partial pressure of the solute in the gas in equilibrium with the solution, c is the concentration of the solute and kH is a constant with the dimensions of pressure divided by concentration. The constant, known as the Henry's law constant, depends on the solute, the solvent and the temperature. The relationship between the solubility of CO.sub.2 and temperature is shown below.
(48) TABLE-US-00001 Temperature ( C.) 0 10 20 30 40 50 80 100 Solubility 1.8 1.3 0.88 0.65 0.52 0.43 0.29 0.26 (cm3 CO.sub.2/g water)
Thus, using Henry's law in combination with the measured concentration of CO.sub.2 gas in equilibrium with the dialysate, the concentration of dissolved CO.sub.2 in the dialysate can be determined.
(49) As shown by the Henderson-Hasselbach equation above, once the CO.sub.2 of the dialysate has been determined, calculating the pH of the dialysate will yield the values that are necessary to calculate the bicarbonate concentration of the dialysate.
(50) The dialysate collection unit 300 is coupled to the module 105 such that the pH reactive material 309 is aligned with the pH sensor 401. As described above, when dialysate flows through the main body, the dialysate contacts and reacts with the pH reactive material 309 which can be a pH indicator strip. In general, a pH indicator strip is a material that changes color depending on the pHthe acidity or alkalinityof a liquid. pH indicators are sometimes weak acids or weak bases that change color at specific pHs. For instance, methyl red is a common indicator that is red at pH of 5 and yellow at a pH of 6. Indicators which are covalently bonded to the strip substrate can be used when using indicator strips to avoid contamination of the dialysate. In some examples, the pH reactive material 503 can be a sol-gel that is applied to one or more inner surfaces of the pH measurement chamber 309. The sol-gel can be of a type that reacts with the dialysate to change color in a manner similar to that of a pH indicator strip.
(51) In some examples, the pH reactive material 309 is coupled to an inner, clear surface of the main body of the dialysate collection unit 300 (e.g., a surface opposite the pH sensor 401, as shown in
(52)
(53)
(54)
(55) In some examples, it is also possible to measure bicarbonate levels or other chemical properties of a sample fluid (e.g., blood or dialysate) using other related techniques.
(56) In
(57) Once the sample fluid has been drawn into the measurement system 804, the sample fluid can be subjected to a number of conditions in order to identify one or more chemical properties of the sample fluid. For example, as described below, the measurement system 804 can be used to determine the blood urea nitrogen (BUN), ammonia (NH.sub.3), and total carbon dioxide (CO.sub.2, as a sum of pCO.sub.2 and bicarbonate) levels of the sample fluid. By liberating certain gases from the sample fluid using one or more conditions such as heat, chemical compounds, changes in pressure, or a combination thereof, an optical detection system that includes a laser 820 and an optical detector 822 can be used to identify properties of the sample fluid based on the liberated gases that rise into beams emitted by the laser 820. Other light sources and optical filters may be used in place of a laser.
(58) As shown in
(59) The measurement system 804 can also be used to measure the total CO.sub.2 of the sample fluid, where the total CO.sub.2 represents the sum of pCO.sub.2 and bicarbonate. In some examples, the fluid line 802 is arranged in position 1 and deposits sample fluid into the heated channel 812. The sample fluid travels down the heated channel 812 (which is formed in a declined surface of the heater block 806) and is deposited in a first chamber 816 of a container unit 808 that includes the first chamber 816 and a second chamber 818. In some examples, the container unit 808 can be a disposable unit that is discarded after a predetermined number of uses or after a predetermined time of service. The first chamber 816 contains an acid (e.g., diluted HCL) that has been heated to a predetermined temperature depending upon the desired reaction rate (e.g., 70 C.). Solid acids may also be used with the advantage of not evaporating during the course of the treatment. Metal bicarbonates (e.g., NaHCO3) are decomposed by acid (e.g. NaHCO.sub.3+HCL.fwdarw.NaCl+H.sub.2CO.sub.3, H.sub.2CO.sub.3.fwdarw.CO.sub.2+H.sub.2O), so depositing the sample fluid in the acid in the first chamber 816 will liberate CO2 gas associated with the decomposition of bicarbonates such as HCO.sub.3. Furthermore, because the vapor pressure of CO.sub.2 is higher than that of water, depositing the sample fluid in acid at a sufficiently high temperature will liberate substantially all of the dissolved CO2 from the sample fluid. Thus, the total CO.sub.2 (pCO.sub.2+bicarbonate) of the sample fluid can be determined by measuring the total CO.sub.2 emitted from the sample fluid deposited into the first chamber 816.
(60) The liberated CO.sub.2 gas travels up the chimney 805 into the path of the beam 826 emitted by the laser 820. The beam 826 is emitted at a wavelength (e.g., 2.10 m) that overlaps an absorption spectrum of CO.sub.2 gas but does not overlap the absorption spectrums of one or more of NH.sub.3 gas, acid gas, and water vapor. Accordingly, in a manner similar to that discussed above, the detector 822 can determine the level of CO.sub.2 in the gas emitted from the sample fluid that was deposited into the first chamber 816. The level of bicarbonate or pC0.sub.2 associated with the sample fluid can also be determined by calculation. For example, the CO.sub.2 concentration detected may be integrated over the detection time to give total CO.sub.2 emission in moles, giving moles of NaHCO.sub.3 (1:1). The NaHCO.sub.3 concentration may be computed from a known weight or volume of fluid; however, other salts may also contribute CO.sub.2.
(61) The measurement system 804 can also be used to measure the level or urea in the sample fluid. In some examples, the fluid line 802 is arranged in position 2 and deposits sample fluid into the heated channel 814. The sample fluid travels down the heated channel 814 (which is formed in a declined surface of the heater block 806) and is deposited in the second chamber 818 of the container unit 808. This container includes conditions that can liberate gases associated with the urea content of the sample fluid. For example, the second chamber 818 can contain a urease (e.g., jack bean meal urease) that decomposes the urea in the sample fluid, resulting in CO.sub.2 and NH.sub.3 reaction product gases. Either the CO.sub.2 or the NH.sub.3 reaction product gases can be measured using the laser 820 and the detector 822 to provide the level of urea in the sample fluid. Depending which reaction product gas is selected to be used as an indication of the urea in the sample fluid, a laser that has a wavelength overlapping an absorption factor of the selected reaction product gas is used to detect the properties of the gases emitted from the sample fluid.
(62)
(63) A portion of the sample fluid is caused to flow into a chamber to liberate a first CO.sub.2 gas (904). For example, as shown in
(64) A level of total CO.sub.2 in the sample fluid is determined based at least in part on the first CO.sub.2 gas (906). For example, using the laser detection arrangement shown in
(65) A portion of the sample fluid is caused to enter a second chamber to liberate a second CO.sub.2 gas (908). For example, the fluid line 802 can be actuated to a second position in order to deposit a second portion of the sample fluid (or all of the sample fluid) into a second heated channel that leads to a second chamber, or both chambers may be on a movable stage. The sample fluid can be heated to liberate one or more gases while the sample fluid travels toward the second chamber. The second chamber includes conditions to liberate gases from the sample fluid. For example, the second chamber can include a urease (e.g., jack bean meal urease) that decomposes urea to liberate a product CO.sub.2 gas. The amount of reactant provided in the second chamber should be sufficient to resist contaminates for the duration of the desired testing period (e.g., one chemical level test, one dialysis treatment session, or longer). The second chamber may contain other conditions, such as heat and/or pressure, which may also interact with the sample fluid to liberate a product gas. The liberated gases can drift upward toward a measurement point (e.g., the liberated gases can drift up a chimney such that they pass through one or more laser beams that traverse an opening of the chimney). While CO.sub.2 is used in this example as the product gas that will be measured, other gases could also be selected to serve as an indicator of the amount of urea in the sample fluid. For example, NH.sub.3 can also be liberated in the second chamber using jack bean meal urease and can be measured to determine the amount of urea in the sample fluid.
(66) A level of total urea in the sample fluid is determined based at least in part on the second CO.sub.2 gas (910). For example, using the laser detection arrangement illustrated in
(67) After one or both of the total CO2 and the total urea levels have been determined, adjustments can be made to the chemical composition of dialysate within the dialysis system. These adjustments can also be made to affect changes in the blood chemistry of a patient undergoing dialysis treatment.
(68) In some examples, the measurement system 804 can be used to measure an amount of ammonium (NH.sub.4+) in a sample fluid using a slightly different configuration. A hydrophobic membrane can be arranged in a wall of a fluid line containing the sample fluid, with a sealed chamber located on the opposite side of the membrane. Using this configuration, gas concentration will reach an equilibrium in the fluid and in the chamber on the other side of the membrane and can thus be measured by any suitable detection mechanism, such as those described above with regard to
(69) In some examples, if the sample fluid is dialysate, determining the chemical properties of the dialysate using the techniques described above can allow for the determination of certain aspects of a patient's blood chemistry. For example, if the total CO.sub.2, NH.sub.3, and urea are measured in a sample of dialysate, the total CO.sub.2, NH.sub.3, and urea can be determined for the patient's blood as well based at least in part on the measured properties of the sample dialysate.
(70) In some examples, the extraction point for the sample fluid can affect what inferences may be drawn from the chemical properties measured in the sample fluid. For example, if dialysate is extracted near the output of a dialyzer, properties of the extracted dialysate can be used to infer chemical properties of a patient's blood. If the dialysate is extracted near the input of a dialyzer, the chemical properties of the dialysate can be used to infer a measure of the efficiency of toxin removal or the correct infusion of replacement substances such as bicarbonate. Regardless of the extraction point, adjustments in the chemical composition of the dialysate can be made based on the measured chemical properties of the extracted sample fluid.
(71) While the condition that causes the decomposition of urea in the second chamber 818 has been described as a urease, applying a threshold level of heat and/or pressure to the sample fluid can also cause the liberation of product gases that can be used to determine the amount of urea in the sample fluid.
(72) While the examples above describe the use of a laser 822 and a detector 824 to measure the level of CO.sub.2 in a gas, other types of CO.sub.2 sensors can be used to accomplish a similar effect.
(73) While the examples above describe the pH sensor 401 as a camera or a phototransistor, the pH sensor 401 can also include one or more colorimeteric sensors. In general, a colorimeteric sensor is a semiconductor chip that senses color.
(74) While certain implementations have been described, other implementations are possible.
(75) In some implementations, the module 105 alternatively or additionally includes conductivity meters positioned slightly upstream of the sodium chloride container 138 and/or slightly upstream of the infusate solution container 136. These conductivity meters can be used to control the amounts of sodium chloride solution and/or infusate solution delivered to the fluid passing through the fluid outlet line 134.
(76) Blood can also be extracted as a sample fluid from the blood component set 225 (or from another component) via a pump, and techniques similar to those described above can be used to determine bicarbonate levels of the blood, as well as other blood chemistry information. Blood can also be used as a sample fluid to determine chemical properties of dialysate within a dialysis system using techniques similar to those described above. An ultrafilter or plasmafilter may also be used to remove macromolecules and cellular materials to prevent fouling of the chemical analysis system and to assure that the CO.sub.2 content measured is in the plasma, and not in the red cells.
(77) While the external components (e.g., the sorbent device 120, the bicarbonate measurement unit 125, the bicarbonate container 191, the infusate container 136, the sodium chloride container 138, the bag 180, the dialysate bag 202, the drain container 203, and their associated fluid lines) connected to the module 105 have been described as being disposable, single use disposable components, any of these components can alternatively be reusable. For example, they can be constructed to withstand disinfection techniques, such as chlorine bleach rinses and/or other chemical rinses.
(78) While the systems described herein have been described as including dialysate recycling modules that are connected to the dialysis machine 110, other arrangements are possible. In some implementations, for example, the various components of the module are incorporated into a single dialysis machine.
(79) While the hemodialysis system 100 is configured so that dilution water is introduced into the dialysate before the dialysate reaches the sorbent device 120 and sodium chloride solution is introduced into the dialysate after the dialysate exits the sorbent device 120, other arrangements are possible. In certain implementations, for example, the system is configured such that the dilution water and sodium chloride solution are both introduced to the dialysate before the dialysate enters the sorbent device 120. The pumps, pump lines, and line segments associated with the delivery of the dilution water container 141 and the sodium chloride solution container 138 can, for example, be reconfigured to deliver the dilution water and sodium chloride solution to the flowing dialysate. Alternatively, lines extending from the dilution water container 141 and the sodium chloride solution container 138 can be connected to a common line via an actuated three-way valve. The three-way valve can be actuated in a manner so that as the pump associated with the pump line is operated dilution water, sodium chloride solution, or no liquid is delivered to the dialysate via the common line.
(80) While the systems described above are configured to deliver dilution water (e.g., tap water) to dialysate before the dialysate enters the sorbent device 120 (i.e., at a pre-sorbent device location), any of the systems described herein can alternatively or additionally be configured so that dilution water is introduced to dialysate after the dialysate exits the sorbent device 120 (i.e., at a post-sorbent device location). In such implementations, the dilution water would not pass through the sorbent device 120 before being delivered to the dialyzer 135. Therefore, the dilution water in such implementations would typically be a pre-filtered or purified water, such as AAMI water.
(81) While the systems described above use the sorbent device 120 to remove toxins from the spent dialysate, other types of devices can alternatively or additionally be used to remove toxins from the spent dialysate.
(82) While the systems describe above describe the bicarbonate measurement unit 125 being positioned to receive dialysate just before the dialysate enters the hemodialysis machine 110, the bicarbonate measurement unit 125 can be positioned at other locations along the fluid path of the dialysate. Additionally, one or more additional bicarbonate measurement units may be provided to measure levels of bicarbonate at other points within the dialysis system 100. For example, an additional bicarbonate measurement device 125 could draw dialysate from the fluid line 258 (