JP5259159B2

Medical fluid therapy flow control systems

Abstract

This record has no abstract on file.

Term

No projected expiry on record.

21 claims: 3 independent, 18 dependent

1
A hemofiltration system for treating renal failure:腎不全を処置するための血液濾過システムであって: Hemofiltration device that communicates with extracorporeal circuits;体外回路と連絡する血液濾過デバイス;A first pump that is in fluid communication with the first line and pumps fluid to the hemofiltration device;第1ラインと流体連絡する第1ポンプであって、該血液濾過デバイスに流体をポンプ輸送する形態の第1ポンプ;A second pump that connects the fluid to the second line and pumps the fluid from the hemofiltration device;第2ラインと流体連絡する第2ポンプであって、該血液濾過デバイスから流体をポンプ輸送する形態の第2ポンプ;An equilibrium chamber in fluid contact with the first line and the second line, wherein the equilibrium chamber contains a flexible membrane that creates two variable capacitance cavities therein, as well as fresh and used fluids. Equilibrium chamber, which is a form that exchanges the capacity of 該第1ラインおよび該第2ラインと流体連絡する平衡チャンバであって、該平衡チャンバがその中に2つの可変容量キャビティを生成する可撓性の膜を含み、そして新鮮および使用済み流体の同様の容量を交換するような形態である平衡チャンバ;Multiple valves;and to operate the multiple valves and allow the used fluid drawn from the equilibrium chamber to supplement the volume of fresh fluid delivered to the hemofiltration device.、Through a recirculation loop containing the second line、A hemofiltration system, comprising a control scheme, which is programmed to allow recirculation into the equilibrium chamber. 複数のバルブ;および該複数のバルブを作動し、該平衡チャンバから引き出された使用済み流体が、該血液濾過デバイスに送達される新鮮流体の容量を補填するために、該第2ラインを含む再循環ループを通って、該平衡チャンバに再循環されることを可能にするようにプログラムされた制御スキーム、を備える、血液濾過システム。
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A hemofiltration system for treating renal failure:腎不全を処置するための血液濾過システムであって: Hemofiltration device that communicates with extracorporeal circuits;体外回路と連絡する血液濾過デバイス;A first pump that connects the fluid to the first line and pumps the fluid to the hemofiltration device and the extracorporeal circuit;第1ラインと流体連絡する第1ポンプであって、該血液濾過デバイスおよび該体外回路に流体をポンプ輸送する形態の第1ポンプ;A second pump that connects the fluid to the second line and pumps the fluid from the hemofiltration device;第2ラインと流体連絡する第2ポンプであって、該血液濾過デバイスから流体をポンプ輸送する形態の第2ポンプ;An equilibrium chamber in fluid contact with the first line and the second line, wherein the equilibrium chamber contains a flexible membrane that creates two variable capacitance cavities therein, as well as fresh and used fluids. Equilibrium chamber, which is a form that exchanges the capacity of 該第1ラインおよび該第2ラインと流体連絡する平衡チャンバであって、該平衡チャンバがその中に2つの可変容量キャビティを生成する可撓性の膜を含み、そして新鮮および使用済み流体の同様の容量を交換するような形態である平衡チャンバ;Multiple valves;and the second line to operate the multiple valves and allow the used fluid drawn from the equilibrium chamber to supplement the volume of fresh fluid delivered to the hemofiltration device and the extracorporeal circuit. A hemofiltration system comprising a control scheme, programmed to allow recirculation into the equilibrium chamber through a recirculation loop comprising. 複数のバルブ;および該複数のバルブを作動し、該平衡チャンバから引き出された使用済み流体が、該血液濾過デバイスおよび該体外回路に送達される新鮮流体の容量を補填するために該第2ラインを含む再循環ループを通って該平衡チャンバに再循環されることを可能にするようにプログラムされた制御スキーム、を備える血液濾過システム。
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A hemofiltration system for treating renal failure:腎不全を処置するための血液濾過システムであって: Hemofiltration device that communicates with extracorporeal circuits;体外回路と連絡する血液濾過デバイス;A first pump that connects the fluid to the first line and pumps the fluid to the extracorporeal circuit;第1ラインと流体連絡する第1ポンプであって、該体外回路に流体をポンプ輸送する形態の第1ポンプ;A second pump that connects the fluid to the second line and pumps the fluid from the hemofiltration device;第2ラインと流体連絡する第2ポンプであって、該血液濾過デバイスから流体をポンプ輸送する形態の第2ポンプ;An equilibrium chamber in fluid contact with the first line and the second line, wherein the equilibrium chamber contains a flexible membrane that creates two variable capacitance cavities therein, as well as fresh and used fluids. Equilibrium chamber, which is a form that exchanges the capacity of 該第1ラインおよび該第2ラインと流体連絡する平衡チャンバであって、該平衡チャンバがその中に2つの可変容量キャビティを生成する可撓性の膜を含み、そして新鮮および使用済み流体の同様の容量を交換するような形態である平衡チャンバ;Multiple valves;and a recirculation loop containing the second line to operate the multiple valves and allow the used fluid drawn from the equilibrium chamber to compensate for the volume of fresh fluid delivered to the extracorporeal circuit. A hemofiltration system, comprising a control scheme, programmed to allow recirculation into the equilibrium chamber through. 複数のバルブ;および該複数のバルブを作動し、該平衡チャンバから引き出された使用済み流体が、該体外回路に送達される新鮮流体の容量を補填するために該第2ラインを含む再循環ループを通って該平衡チャンバに再循環されることを可能にするようにプログラムされた制御スキーム、を備える血液濾過システム。

Independent claims3

75 paragraphs, as filed

The present invention relates to a medical system, particularly to a drug solution therapy.

Disease, injury or other causes can cause the human kidney system to fail. In the case of renal failure of any cause, there are several physiological disorders. The equilibrium of water, minerals and excretions of the daily metabolic load is reduced or not possible in the case of renal failure. In the event of renal failure, toxic end products of nitrogen metabolism (eg, urea, creatinine, uric acid, etc.) can accumulate in blood and tissues.

Renal failure and hypofunction have been treated with dialysis. Dialysis removes from the human body waste, toxins and excess water that would otherwise have been removed by the functioning kidneys. Dialysis therapy, which replaces renal function, is essential for many because it is a life-sustaining treatment. People with renal dysfunction cannot sustain life, at least without alternatives to the filtering function of the kidneys.

Hemodialysis (HD), hemofiltration (HF), hemodiafiltration (HDF) and peritoneal dialysis (PD) are commonly used to treat loss of renal function. Peritoneal dialysis uses a bactericidal dialysis solution, or "dialysis fluid," which is injected into the patient's abdominal cavity and comes into contact with the patient's peritoneum. Waste products, toxins and excess water are sent from the patient's bloodstream through the peritoneum into the dialysate. The transport of waste products, toxins and excess water from the bloodstream into the dialysate is caused by diffusion and penetration during the pause period as the penetrants in the dialysate form an osmotic gradient across the membrane. The used dialysate is later drained from the patient's abdominal cavity to remove waste products, toxins and excess water from the patient.

Hemodialysis therapy removes waste products, toxins and excess water directly from the patient's blood. The patient is connected to a hemodialysis machine and the patient's blood is pumped from the machine. The needle or catheter is inserted into the patient's veins and arteries to form a blood flow path to and from the hemodialysis machine. As blood passes through the dialysis machine in the hemodialysis machine, the dialysis machine removes waste products, toxins and excess water from the patient's blood and returns the washed blood to the patient. For example, a large amount of dialysate of about 90 to 120 liters is used by most hemodialysis machines, and the blood is dialyzed during one hemodialysis treatment. The used dialysate is discarded. Hemodialysis therapy lasts for several hours and is typically given at a treatment center about three times a week.

Hemofiltration is an effective convection-based blood cleaning technique. Access to blood can be via the static vein or the arteries and veins. As blood flows through the hemofilter, the intermembrane pressure gradient between the blood compartment and the ultrafiltration compartment allows plasma water to be filtered across the highly permeable membrane. When water crosses the membrane, it convects small and large molecules across the membrane to wash the blood. Large amounts of plasma water are eliminated by filtration. Therefore, in order to maintain the equilibrium of water in the body, the fluid must be continuously replenished with an equilibrium electrolyte solution (replacement or replenisher) injected intravenously. The replacement fluid can be injected into the arterial blood line leading to the hemofilter (pre-dilution), or into the venous blood line exiting the hemofilter (post-dilution), or both. Another type of treatment, hemodiafiltration, combines hemodialysis and hemofiltration diffusion and convection lavage modes.

The hematocrit of a patient, which is the proportion of red blood cells in the blood, is about 32 to 36% by volume, and the amount of fluid in the blood is in the range of about 64 to 68%. In typical HDF and HF therapies, the blood flow is about 300 milliliters per minute, about 100 milliliters of fluid per minute is removed through the filter, and a relatively small percentage of blood exits the hemofilter and then. It remains as a fluid that receives a certain amount of dialysate.

Post-dilution is a more efficient blood purification mode than pre-diluted HF or HDF. In some cases, post-diluted HF or HDF may be 50% more effective than pre-diluted HF or HDF. However, in the case of post-dilution purification, the blood leaves the human body and enters the filter before the extracorporeal circuit contains the therapeutic fluid or dialysate. Post-dilution purification condenses or coagulates the hemofilter, as a hemodialysis device or hemofilter can remove a good portion of the liquid from the patient's blood. Prediluted purification, on the other hand, injects fresh therapeutic fluid into the extracorporeal circuit prior to the filter, at least substantially reducing blood coagulation in the hemofilter or hemodialysis machine.

In the case of pre-diluted HF or HDF, the dialysate is fed to the extracorporeal circuit prior to the hemofilter. Second, some of this fluid is immediately removed by the filter, so the therapeutic effect is lower than post-dilution therapy. However, the blood leaving the filter has the same proportion of fluid as when the blood exits the patient, eg 64-68%, and the blood has a very high proportion of solids, causing platelets to coagulate or The possibility of agglomeration is reduced.

Therefore, it is desirable to provide hemofiltration and / or hemodiafiltration that can perform both pre-dilution and post-dilution purification modes.

It is also desirable to provide an HF and / or HDF system that provides priming function, bolus volume infusion function and / or blood rinseback function. System priming is done at the beginning of treatment to remove air from the line, as it is harmful when supplied to the patient. The prime purges the air with a sterile or substantially sterile electrolyte solution.

It is necessary to supply the patient with a bolus amount or a relatively large amount of fluid for a certain period of time during HF or HDF treatment. During treatment, too much blood may be removed from the patient too quickly. The patient's vasculature contains only 5-6 liters of blood. Excessively removing too much blood can reduce the pressure in the vascular interstitial space. The patient's heartbeat becomes faster and the vascular system contracts in an attempt to compensate for the decrease in blood pressure, but such measures are not sufficient to prevent the patient from becoming hypotensive. In this case, supplying the patient with a bolus amount or a large amount of fluid is one effective procedure for raising blood pressure in the vascular system.

In addition, it is desirable to have an HF or HDF system capable of performing a blood rinse back at the end of treatment. At the end of treatment, there is generally blood remaining in the extracorporeal circuit. It is desirable to return as much blood as possible to the patient. Therefore, the blood therapy system needs to be able to pass a large amount of fluid through the blood circuit to push the blood remaining in the blood circuit back to the patient.

Both the bolus amount function and the rinseback function present a problem to the machine maker. For example, if the machine uses a fluid equilibrium system or a compatible flow balancer that removes an equal amount of fluid from the patient and supplies each amount of fluid to the patient, such an equilibrium system produces a positive net fluid volume for the patient. Must be considered so that it can be supplied to. Second, the bolus volume or rinseback fluid must be sterile or injectable quality as the fluid is fed directly to the extracorporeal circuit.

Removing the ultrafiltration solution (UF) from the patient is a precise task that requires the removal of a specific amount of fluid from the patient during the course of treatment. Therefore, the amount of fluid removed from the patient needs to be carefully monitored. In this connection, problems arise when one or more devices that control the speed or amount of UF discharged fail, for example when a valve fails. Therefore, it is desirable to have an ultrafiltration flow control device that blocks the fluid flow due to failure and does not result in uncontrolled UF removal.

Certain HF and HDF machines produce fluids that are used at the time and location of treatment during treatment. These machines are called "online" machines because they produce and supply solutions online. The online machine uses a microfilter or ultrafilter to sterilize the solution or bring it to injectable quality before feeding the solution to the patient's extracorporeal circuitry. Over time, the filter accumulates bacterial and intracellular toxins along the outer filtration surface of the membrane located within the filter. Therefore, it is desirable to have a method and device that removes, or at least reduces, the amount of bacterial and intracellular toxins that accumulate and are present along the membrane of the filter used to produce dialysate online. ..

(Disclosure of Invention) The present invention provides systems and methods for improving a drug solution supply system, such as a hemodialysis (HD), hemofiltration (HF) and hemodiafiltration (HDF) system. The present invention comprises a plurality of aspects relating to the flow of the drug solution. In one aspect, a system and method of selectively performing pre-dilution and post-dilution HF and HDF purification modes is provided. In another aspect, a system and method for providing priming, bolus volume and volume of rinseback fluid during / after HF and HDF treatment is provided. Yet another major aspect provides an improved system and method for removing the ultrafiltration from the patient. The present invention, in yet another aspect, provides improved filtration configurations and methods. One aspect of the invention provides an HF or HDF system in which pre-dilution purification modes and post-dilution purification modes are performed, for example, together or simultaneously. The system rigidly uses flow components that perform both pre-dilution purification mode and post-dilution purification mode. For example, the system does not require an extra pump or additional pump segment located within the replenisher line, and such additional components are mechanically responsive to alarms and operator settings, etc. Will have to be incorporated within. The pre / post dilution function of the present invention uses the "Y" connector located at the output of the replenishment line of the system instead. The first leg of the "Y" connector extends into the post-dilution infusion chamber. The first check valve is located on the first leg to prevent blood from flowing back into the first leg or the replenisher infusion line. The second leg of the "Y" can be used for multiple purposes, such as connecting to a pre-dilution infusion chamber or arterial line to prime extracorporeal circuits. In the present invention, the second leg is used to supply dialysate, pre-filter to the blood line. Therefore, the second check valve is located on the second leg to prevent blood from flowing back into the replenishment line. One or two refill line pinch clamps are provided at the inlet of each leg of the "Y" connector leg. In one embodiment, the arterial line is primed if pre-dilution and post-dilution are desired during the same treatment. When the patient or nurse is ready to connect the dialysate line to the dialyzer, the second leg of the "Y" connector is fluidly connected to the arterial infusion chamber located upstream from the blood pump. The first leg of the "Y" connector is fluidly connected to the IV chamber. Pinch clamps on the electrically or pneumatically operated replenishment line are located on each of the first and second legs extending from the "Y" connector to control the amount of replenisher used for pre-dilution and post-dilution injections. To do. In one embodiment, the operator sets the total target replenisher volume received by the patient. In addition, the operator enters a pre-dilution vs. post-dilution setting, so that, for example, a specific pre-dilution volume or flow rate or post-dilution volume or flow rate is set, or a pre-dilution vs. post-dilution rate is entered. To do. After starting treatment, one replenishment pump operates continuously and the clamp alternately achieves the desired pre-dilution and post-dilution rates. For example, if the total replenishment flow is 150 ml / min (ml / min) and a pre-dilution flow of 50 ml / min is desired, close the post-dilution clamp, open the pre-dilution clamp for example 5 seconds, then Close the pre-dilution clamp and open the post-dilution clamp for 10 seconds. The result is a continuous flow of fluid to either the arterial or intravenous drip chamber, for example, with improved purification capacity, post-dilution therapy is performed for most of the time, resulting in blood coagulation and hypotension. Pre-dilution therapy is performed for a time sufficient to prevent it. The system is provided with alarms and guarantees, such as sensors that detect if one or both clamps are in the wrong position and both clamps close at the same time. In this case, the machine sends an appropriate alarm and takes appropriate evasive action. There are many alternative techniques for sensing the position of the clamp, such as microswitches, reed switches, Hall effect switches, light sensing, ultrasonic sensing, pressure conversion qi. Another aspect of the invention provides an HF / HDF system that performs specialized fluid delivery functions such as prime, bolus volume function using fluid components in an effective sequence and blood rinseback. These functions can be initiated manually or automatically, for example, after receiving a signal from the appropriate biosensor. In one embodiment, a two-way isolation valve is placed within the post-dialysis machine therapeutic fluid or dialysate circuit. The isolation valve is electrically or pneumatically controlled by a mechanical controller to perform one of its functions at a desired time during treatment. In one embodiment, the isolation valve is used to inject a bolus volume, for example, to stabilize a patient with low blood pressure, i.e. hypotension. The bolus amount is predetermined or entered when needed. After an operator's input or an appropriate signal from the sensor, the bypass valve on the upstream dialysate line closes or deenergizes, resulting in a stop of normal flow to the dialyzer and the power supply for the ultrafiltration fluid flow meter. Will expire. The isolation valve located downstream of the dialysis machine is also closed and the dialysis machine is isolated between the bypass and the isolation valve. The limit of the intermembrane pressure difference (TMP) alarm that can be operated during normal treatment is disabled and the dialysis machine is isolated. After the purge valve located upstream from the bypass valve opens and was previously sent to the drain tube, the fluid from the dialysis machine is drained through the purge valve to accommodate the flow of fluid to the patient through the equilibrium chamber or flow balancer. be able to. The amount of fluid flowing to the patient flows through at least one filter, exits the replenishment port, is pumped into the IV chamber via the replenishment pump, and flows to the patient through the venous approach line. After the bolus volume is supplied, the purge valve is closed and the patient's blood pressure stabilizes. The isolation valve is then opened, the TMP limit is reset, and normal treatment resumes. The above device is also suitable for rinsing back the replenisher at the end of treatment to wash the blood remaining in the extracorporeal circuit and return it to the patient. In this case, the operator presses the "rinse back" button and probably presses the "verify" confirmation input to start the procedure. Rinse-back functions such as bolus amount can be started automatically. The amount of rinseback solution is preset or set during the procedure. The above valve configuration and operation is repeated with bypass valves, isolation valves, TMP alarm limits, and purge valves. The replenishment pump supplies the patient with a programmed rinse-back amount. The solution is also pulled back from the system to equilibrate the fluid flowing to the patient through a compatible flow balancer. In this case, as much extracorporeal circuit as possible is cleaned because this amount is supplied to the arterial approach line in front of the arterial infusion chamber rather than being supplied to the intravenous dialysis machine as in the case of bolus volume solution. To connect the replacement pump to the arterial approach line, the operator can connect the approach line to the second leg of the "Y" connector described above. Alternatively, when the system is used in combination with the pinch clamp described above, the post-dilution clamp closes and the pre-dilution clamp opens, allowing automatic operation. The machine is set to alert the operator when the rinseback is complete. After the fluid pressure stabilizes, the purge valve closes, the isolation and bypass valves open, the TMP limit is activated, and treatment is terminated by normal procedures. In yet another aspect of the invention, the machine replaces the more complex, more accident-prone, and more expensive diaphragm pump type UF flowmeter assembly due to ultrafiltration (UF). , Use a ceramic piston rotary reciprocating pump. The location of the ceramic pump is the pre-dialysis machine directly downstream of the purge valve. The rotary reciprocating piston pump can operate at a reasonably high rate of speed, such as 4-8 liters per hour, in wash and sterilization modes. During treatment, the pump operates at a flow rate equal to the desired patient UF rate. The flow rate of the replenisher and the equivalent amount of the patient's UF are obtained from the predialysis machine in the channel, i.e., the fresh solution is removed from the system. In one embodiment, the ceramic pump operates in an equilibrium chamber that adds and removes an equal amount of fluid to and from the system. The fluid that the ceramic piston pump obtains from the system and the replenisher given to the patient as an HDF or HF infusion are automatically removed from the patient by the post-flow balancing chamber. The fresh solution is removed from the dialysate downstream from the dialysate flow path and thus the equilibrium chamber so as not to impair the dialysate equilibrium. There are many advantages when using ceramic pumps and associated flow configurations. Rotating reciprocating ceramic piston pumps flow directly from the input to the output, in contrast to the balanced chamber type UF flowmeter. Failure of a balanced chamber type UF device can result in uncontrolled flow in the middle of the cycle, resulting in patient overfiltration. On the other hand, the piston pump of the present invention is not affected by this type of failure because its input port does not fluidly communicate with the pump outlet port. If the pump fails, it closes and stops the fluid flow. This piston also prevents UF errors due to purge valve errors. Pump rotation is monitored using reed switches, optical sensors, flow meters, speedometers or other types of feedback devices, pump rotation, and the corresponding ultrafiltration amount removed by individual mechanisms. Can be inspected. The pump is placed in front of the dialysis machine to prevent the pump from being blocked by organic matter removed from the dialysis machine. However, the pump is located downstream from at least one membrane filter used to facilitate purification of fresh dialysate. This configuration provides continuous purification along the surface of the filter membrane. This purification removes at least a portion of the accumulation of bacterial and intracellular toxins along the membrane surface. Yet another advantage is that this configuration also removes air from the membrane filter during treatment. Removing the equilibrium chamber type UF meter and adding a rotary reciprocating pump will relatively simplify the flow path of the dialysis system and improve equipment safety and performance. The ceramic piston pump according to one embodiment is used to perform the rinseback and bolus volume injection functions described above. The pumps of these examples operate in opposite directions so that the flow moves to the patient. In yet another aspect, an improved filter configuration and filtration method is provided. This configuration comprises at least two filters, which are arranged in series between a pump or other hydraulically complex flow mechanism. The filter portion of the dialysate flow path reduces the accumulation of bacterial and intracellular toxins. Also, the pump located upstream of the filter operates to produce a higher flow rate than the pump located downstream of the filter. This flow rate difference also helps to exfoliate the accumulated bacteria and intracellular toxins from the membrane surface located within the filter and the tubes connecting the filters. Each of the above embodiments can be used alone or in some combination with each other. Therefore, an advantage of the present invention is to provide a hemofiltration (HF) or hemodiafiltration (HDF) system that can perform pre-dilution purification mode and post-dilution purification mode with a single replenishment pump. Another advantage of the present invention is to provide an HF or HDF system that performs certain positive net fluid flow functions such as prime, bolus volume and rinseback functions. Yet another advantage of the present invention is to provide an improved ultrafiltration fluid flow metering system. Yet another advantage of the present invention is to provide an HF or HDF system with improved safety features. Further, an advantage of the present invention is to provide an HF or HDF system with a simplified flow form. Further, an advantage of the present invention is to provide an HF or HDF system with improved performance features. Yet another advantage of the present invention is to provide an HF or HDF system with improved filtration systems and methods.In addition to the above, the present invention provides:(Item 1)It s a chemical system, A chemical flow path having a chemical supply source, a first pump that can operate to lift the chemical from the source to an extracorporeal circuit, and a second pump that can operate to lift the fluid from the hemofiltration device. , A branch located downstream from the first pump and (i) a branch, (ii) a first clamp device that can selectively allow and block the flow through the first branch line, and (iii) an extracorporeal circuit located upstream from the hemofiltration device. The first branch line that fluidly connects to the first position in the (i) a bifurcation, (ii) a second clamp device that can selectively allow and block the flow through the second bifurcation line, and (iii) an extracorporeal circuit located downstream from the hemofiltration device. The second branch line that fluidly connects to the second position in the A drug solution system comprising a control scheme capable of operating at least one of the first and second clamp devices at a time and selectively.(Item 2)The drug solution system according to item 1, wherein at least two of the bifurcation, the first clamp device, and the second clamp device are packaged together.(Item 3)The drug solution system according to item 1, comprising at least one of a first unidirectional flow device in the first branch line and a second unidirectional flow device in the second branch line.(Item 4)The drug solution system according to item 3, wherein at least one of the first and second unidirectional flow devices is located upstream from the first and second clamp devices, respectively.(Item 5)The drug solution system according to item 1, wherein at least one of the first and second contact positions comprises an air separation device.(Item 6)The drug solution system according to item 1, wherein the first position is located so that the drug solution is supplied sufficiently upstream of the hemofiltration device in the extracorporeal circuit to perform a blood rinseback procedure.(Item 7)The chemical solution system according to item 1, wherein the chemical solution flow path comprises a membrane filter capable of operating to filter the chemical solution, and an ultrafiltration solution pump located downstream from the filter particle discharge outlet of the filter.(Item 8)The drug solution system according to item 1, wherein the first and second clamp devices are controlled via an electronic or pneumatic signal.(Item 9)The chemical system according to item 1, wherein the control scheme can operate to open the first clamp device only for the first designated period and then open the second clamp device for the second designated period only.(Item 10)The chemical system according to item 1, wherein the control scheme can operate to open the first clamp device for a first percentage of time and the second clamp device for a second percentage of time.(Item 11)The control scheme can operate to open one of the first and second clamp devices for the first designated period and then open both the first and second clamp devices for the second designated period. The chemical system according to item 1.(Item 12)The chemical solution system according to item 1, wherein the chemical solution is a solution of injectable quality.(Item 13)The chemical solution system according to item 1, wherein the first pump is stopped when it is detected that the chemical solution is out of at least one of a preset conductive range and a preset temperature range.(Item 14)It s a chemical system, A drug solution flow having a drug solution source, a first pump that can operate to pump the drug solution from the source to an extracorporeal circuit / hemofiltration device, and a second pump that can operate to draw fluid from the hemofiltration device. Road and A device that can operate to isolate the hemofiltration device from the rest of the drug flow path, It comprises a control scheme in which (i) the isolation device isolates the hemofiltration device and (ii) the first pump can selectively and simultaneously instruct the extracorporeal circuit to supply a certain amount of fluid. , Chemical system.(Item 15)The drug solution system according to item 14, wherein the amount of fluid is the amount of bolus supplied during treatment to help prevent the patient's blood pressure from dropping.(Item 16)The drug solution system according to item 15, wherein the control scheme can operate to receive an operator's input to initiate the supply of the bolus amount.(Item 17)The chemical system according to item 15, wherein the amount of bolus amount is entered by the operator when the supply of bolus amount is started.(Item 18)The drug solution system according to item 15, wherein the amount of bolus is predetermined before starting treatment.(Item 19)The drug solution system according to item 15, wherein the control scheme is operational after the input of the biosensor to initiate the supply of the bolus amount.(Item 20)Item 19. The drug solution system according to item 19, wherein the biosensor is selected from the group consisting of a hematocrit sensor, a blood volume sensor, an electrolyte sensor, an oxygen sensor and some combination thereof.(Item 21)The drug solution system according to item 14, wherein the amount of fluid is the amount of rinseback supplied at the end of treatment to wash the blood in the extracorporeal circuit and return it to the patient.(Item 22)21. The drug solution system according to item 21, wherein the control scheme can operate to receive an operator's input to initiate the supply of the rinseback amount.(Item 23)21. The drug solution system according to item 21, wherein the control scheme can act to automatically initiate the supply of rinseback doses at the end of treatment.(Item 24)The drug solution system according to item 21, wherein the amount of rinseback is entered by the operator when the supply of rinseback amount is started.(Item 25)The drug solution system according to item 21, wherein the amount of rinse back is predetermined before the start of treatment.(Item 26)21. The drug solution system according to item 21, wherein the control scheme can operate to supply a rinseback amount until the threshold amount of blood is no longer sensed in the extracorporeal circuit.(Item 27)The drug solution system according to item 14, wherein the amount of fluid is the prime supplied at the beginning of treatment to remove air from the extracorporeal circuit.(Item 28)The drug solution system according to item 27, wherein the control scheme can operate to receive an operator's input to initiate the supply of prime.(Item 29)28. The drug solution system according to item 27, wherein the control scheme can operate to automatically initiate a prime supply at the start of treatment.(Item 30)The drug solution system according to item 27, wherein the amount of prime is entered by the operator when starting the supply of prime.(Item 31)The drug solution system according to item 27, wherein the amount of prime is predetermined prior to the start of treatment.(Item 32)28. The drug solution system according to item 27, wherein the control scheme can operate to supply prime until air is no longer perceived in the extracorporeal circuit.(Item 33)14. The drug solution system of item 14, wherein the system is operational to perform hemodiafiltration and the isolation device comprises first and second valves located upstream and downstream of the hemofiltration device.(Item 34)The drug solution system according to item 14, wherein the system is operable to perform hemofiltration and the isolation device comprises a valve located downstream of the hemofiltration device.(Item 35)The drug solution system according to item 14, wherein the isolation device comprises a bypass valve capable of operating to bypass the fresh drug solution around the hemofiltration device in the drug solution flow path.(Item 36)The drug solution system according to item 14, wherein the drug solution flow path is configured to selectively supply the drug solution to an extracorporeal circuit upstream or downstream of the hemofiltration device.(Item 37)The chemical solution system according to item 14, wherein the chemical solution flow path is configured to remove the ultrafiltration solution from the chemical solution flow path upstream from the position where the chemical solution is supplied to the extracorporeal circuit.(Item 38)The control scheme can be operated to stop the first pump when the drug solution is sensed outside of at least one of a preset conductive range and a preset temperature range, item 14. Chemical solution system.(Item 39)It s a chemical system, A drug solution flow having a drug solution source, a first pump that can operate to pump the drug solution from the source to an extracorporeal circuit / hemofiltration device, and a second pump that can operate to draw fluid from the hemofiltration device. Road and A drug solution system comprising an ultrafiltration solution pump configured and arranged to remove the ultrafiltration solution from the drug solution flow path upstream from the location where the drug solution is supplied to the extracorporeal circuit and hemofiltration device.(Item 40)39. The chemical system according to item 39, wherein when the pump pumps fluid into and out of the pump, there is no fluid communication between the fluid inlet and outlet of the pump.(Item 41)The ultrafiltration fluid pump comprises at least one membrane filtration device capable of operating the chemical flow path to filter fresh chemicals before the fluid reaches the extracorporeal circuit / dialysis machine, and the ultrafiltration fluid pump is the filtered particles of the membrane filtration device. The chemical system according to item 39, located downstream of the exit port.(Item 42)The chemical flow path comprises at least one membrane filtration device capable of operating to filter fresh chemicals before the fluid reaches the extracorporeal circuit / dialysis machine, and an ultrafiltration pump has at least particles from the filtration device. 39. The chemical system according to item 39, which is arranged to wash a portion.(Item 43)The ultrafiltration fluid pump is confined within the filtration device, with at least one membrane filtration device that allows the solution flow path to operate to filter fresh chemicals before the fluid reaches the extracorporeal circuit / dialysis machine. 39. The chemical system according to item 39, which is arranged to purge at least a portion of the air.(Item 44)39. The drug solution system of item 39, wherein the drug solution flow path is configured to selectively supply the drug solution to an extracorporeal circuit upstream or downstream of the hemofiltration device.(Item 45)39. The drug solution system of item 39, comprising an actuating isolation device that isolates the hemofiltration device from other parts of the drug solution flow path so that a positive net drug solution volume can be delivered to the patient.(Item 46)It s a chemical system, In order Chemical solution source and With the first pump With the first filter With the second filter With the third filter It has a chemical flow path that communicates with the second pump, the first pump can operate to pump the chemical through the filter, and the second pump lifts the fluid from the third filter into the extracorporeal circuit. A drug solution system that can operate to pump and has an extracorporeal circuit with a blood filtration device.(Item 47)46. The drug solution system according to item 46, wherein at least one of the first, second and third filters is a microfilter.(Item 48)46. The chemical system according to item 46, wherein at least one of the first, second and third filters is an ultrafilter.(Item 49)46. The drug solution system of item 46, wherein the flow path communicates with at least one flow component and the flow component is located between at least one pair of first, second and third filters.(Item 50)46. The chemical system according to item 46, wherein the filters are arranged in series.(Item 51)It is equipped with a third pump that communicates fluid with the hemofiltration device, the third pump being capacitively matched to the first pump, so that substantially the same amount of fluid entering the extracorporeal circuit is bleeding by the third pump. 40. The chemical system according to item 46, which is removed through a filtration device.(Item 52)The chemical solution system according to item 46, wherein the chemical solution is a fluid of an electrolyte.(Item 53)46. The drug solution system of item 46, wherein the drug solution flow path is configured to selectively supply the drug solution to an extracorporeal circuit upstream or downstream of the hemofiltration device.(Item 54)46. The chemical solution system of item 46, wherein the chemical flow path is configured to remove the ultrafiltration from the chemical flow path upstream from a position where the chemical solution is supplied to an extracorporeal circuit.(Item 55)46. The chemical solution system of item 46, wherein the first pump is stopped when the chemical solution is detected to be outside at least one of a preset conductive range and a preset temperature range.(Item 56)It s a chemical method, With the step of using post-dilution purification mode as the primary means for blood purification, through at least two-thirds of blood treatment for patients, A drug solution method consisting of steps using a pre-dilution purification mode to help prevent the patient's blood from concentrating through less than one-third of blood therapy.(Item 57)56. The drug solution method of item 56, comprising the steps of configuring a pre-dilution purification mode and a post-dilution purification mode to be performed at different times during treatment.(Item 58)56. The drug solution method of item 56, comprising steps constituting at least a portion of the pre-dilution purification mode and the post-dilution purification mode so that they are performed simultaneously within the treatment.(Item 59)56. The chemical method according to item 56, comprising directing the chemicals pumped from the replenishment pump to perform either pre-dilution purification or post-dilution purification.(Item 60)58. The drug solution according to item 56, further comprising a step that allows the drug solution that is first performed and pumped by the replenishment pump to perform both pre-dilution and post-dilution purification at a second point in the treatment. Law.(Item 61)56. The drug solution method according to item 56, which comprises the step of supplying a drug solution in a blood rinse back amount.(Item 62)56. The drug solution method according to item 56, which comprises the step of supplying a bolus amount of the drug solution at the time of treatment.(Item 63)56. The drug solution method of item 56, comprising removing the ultrafiltration from the patient during at least one of the pre-dilution purification mode and the post-dilution purification mode used for blood therapy.(Item 64)63. The drug solution method of item 63, comprising removing the ultrafiltration solution upstream from the position where the drug solution is fed to the patient's extracorporeal circuit during either pre-dilution mode or post-dilution mode.(Item 65)58. The drug solution method of item 56, comprising the step of further injecting the drug solution into the hemofiltration device, at least one of the pre-dilution purification mode and the post-dilution purification mode used for blood therapy.(Item 66)56. The chemical solution method according to item 56, comprising interrupting the flow of the chemical solution when the chemical solution is detected to be outside at least one of the conductive range and the temperature range.(Item 67)It s a chemical method, Steps to inject the drug solution into the extracorporeal circuit / hemofiltration device, The steps to remove the fluid from the hemofiltration device so that the net fluid volume is removed from the patient, With the step of isolating the hemofiltration device from a pump that can operate to remove the fluid from the hemofiltration device, A drug solution method that includes a step of supplying a patient with a certain amount of fresh drug solution.(Item 68)The step of isolating the blood filtration device from the pump is a first portion of the isolation steps, isolation steps, such that fluid does not enter the blood filtration device, bypass the chemical further comprising Ru, according to item 67 Chemical method.(Item 69)67. The drug solution method of item 67, comprising restarting the infusion and removal steps after the amount has been supplied.(Item 70)67. The drug solution method of item 67, comprising the step of supplying the patient with that amount of fresh drug solution at the end of treatment and washing the blood back to the patient.(Item 71)67. The drug solution method of item 67, comprising a step that allows the amount to be selected near the point of supply.(Item 72)67. The drug solution method of item 67, comprising a step that allows the amount to be preselected.(Item 73)67. The drug solution method of item 67, comprising a step that allows the amount to be automatically controlled by supplying the amount until an input from the sensor is received.(Item 74)67. The drug solution method of item 67, wherein the injection and removal steps include selectively performing pre-diluted injection, post-diluted injection, or both at the same time.(Item 75)67. The drug solution method of item 67, comprising removing the ultrafiltration solution upstream from the position where the drug solution is fed to the extracorporeal circuit / hemofiltration device, between at least one of the infusion step and the removal step.(Item 76)67. The chemical solution method according to item 67, which comprises the step of interrupting the flow of the chemical solution when it is detected that the chemical solution is out of at least one of the conductive range and the temperature range.(Item 77)After receiving the input from the biosensor, the biosensor is selected from the group consisting of a hematocrit sensor, a blood volume sensor, an electrolyte sensor, an oxygen sensor and some combination thereof, including a step of automatically supplying the amount. , Item 67.(Item 78)It s a chemical method, With the step of injecting a first amount of fresh drug solution from the source into the extracorporeal circuit / hemofiltration device, With the step of removing a second amount of fluid from the hemofiltration device, The second amount includes the step of removing a third amount of fresh drug solution from the source and preventing the third amount from being fed to the extracorporeal circuit / hemofiltration device along with the first amount. A drug solution method that is substantially equal to the combined amount of the amount of and the third amount.(Item 79)58. The chemical method according to item 78, which comprises the step of removing a third amount downstream from at least one chemical membrane filtration device.(Item 80)Item 78, including the step of removing the third volume through an ultrafiltration pump that can operate to separate the fluid inlet of the pump from the fluid outlet of the ultrafiltration pump during the infusion / drain stroke. The chemical method described in.(Item 81)58. The chemical method according to item 78, which comprises the step of removing a third fluid volume via a pump that can operate to expose the fresh chemical to air.(Item 82)58. The chemical method according to item 78, which comprises the step of cleaning the particles from at least one reusable chemical filter using a third fluid volume.(Item 83)58. The chemical method according to item 78, which comprises the step of purging air from at least one reusable chemical filter using a third fluid volume.(Item 84)28. The drug solution method of item 78, comprising monitoring the removal of the third amount so that the third amount can be controlled to match a predetermined ultrafiltration amount of the patient.(Item 85)The drug solution method according to item 78, wherein the first volume of injection comprises selectively performing pre-diluted injection, post-diluted injection, or both at the same time.(Item 86)58. The drug solution method of item 78, further comprising the step of supplying a blood rinseback amount of the drug solution to an extracorporeal circuit.(Item 87)58. The drug solution method of item 78, comprising supplying a bolus amount of drug solution to an extracorporeal circuit during treatment.(Item 88)58. The chemical method of item 78, comprising the step of recirculating at least a portion of a third volume injected with the source fluid.(Item 89)88. The chemical method of item 88, comprising removing air from the recirculating portion before the portion is combined with the fluid of the source.(Item 90)The chemical solution method according to item 78, which comprises a step of interrupting the flow of the chemical solution when it is detected that the chemical solution is out of at least one of the conductive range and the temperature range.(Item 91)It s a chemical method, A flow path is configured such that the first pump pumps the drug solution through the first filter, the second filter, and the third filter in order, so that the filter removes the intracellular toxin from the drug solution source. Steps that are operational and A chemical method that includes the step of operating a second pump to pump fluid from a third filter into an extracorporeal circuit.(Item 92)The chemical method according to item 91, which comprises the step of filtering bacteria from a medical source.(Item 93)The chemical method according to item 91, which comprises the steps of constructing an extracorporeal circuit such that pre-dilution injection, post-dilution injection, or both are selectively performed at the same time.(Item 94)The chemical solution method according to item 91, which comprises a step of removing the ultrafiltration solution upstream from the position where the chemical solution is supplied to the extracorporeal circuit.(Item 95)The chemical solution method according to item 91, which comprises a step of interrupting the flow of the chemical solution when it is detected that the chemical solution is out of at least one of the conductive range and the temperature range.(Item 96)It s a chemical method, A chemical treatment flow path is configured such that at least one filter is arranged between the upstream first pump and the downstream second pump, and the solution is pumped at a flow rate faster than that of the second pump to be inside the filter. A chemical method that includes the step of operating the first pump to help prevent areas of fluid stagnation in.(Item 97)The chemical method according to item 96, comprising the step of configuring the filter as a reusable filter.(Item 98)The chemical solution method according to item 96, which comprises supplying a filtered chemical solution to an extracorporeal circuit. Yet other features and advantages of the invention are described in the "Detailed Description of the Invention" and drawings below, which will become apparent.

(Detailed description of the invention) The present invention provides systems and methods for improving a drug solution supply system, such as a hemodialysis (HD), hemofiltration (HF) and hemodiafiltration (HDF) system. In various embodiments, systems and methods for selectively performing pre-diluted and post-diluted HF and HDF purification modes are provided. In other embodiments, systems and methods are provided for providing bolus amounts, prime and rinseback fluid amounts during HD, HF and HDF treatments. In yet another embodiment, a system and method for removing the ultrafiltration solution from the patient is provided. In addition, the present invention provides improved filtration configurations and methods.

(Pre-diluted / post-diluted HDF and HF) Next, referring to the drawings, in particular FIG. 1, the HF and / or HDF system 10 is shown. The system 10 of one embodiment is part of a machine capable of performing HD, HF or HDF of choice by a physician or nurse. This machine is commonly used in treatment centers, and in one embodiment, the production unit 12 produces a dialysis solution. One suitable dialysate generation unit 12 for System 10 is described in the maintenance instructions for Baxter's System 1000® treatment machine. However, from the disclosures herein, the invention is not limited to dialysate delivery systems or in-center systems, but rather applies to the treatment of appropriate drug solution therapies.

System 10 comprises a dialysate flow path 20 and an extracorporeal or blood circuit 70, whether operating in HF or HDF mode. In the dialysate flow path 20, the fluid generated by the generation unit 12 is pumped through the supply regulator 16 via the supply pump 14, and the supply regulator 16 sets the maximum pressure of the dialysate in the flow path. To do. The dialysate flow path 20 uses a number of flow control devices that ensure that the desired amount of fluid is delivered and removed from the patient (as described in US Pat. No. 5,486,286 by the same owner as the present application). The implications of this patent are incorporated herein by reference). In particular, the dialysate flow path 20 comprises a flow rate balancer or balance chamber 30 and an ultrafiltration fluid flow meter 50. The flow balancer 30 comprises a pair of fixed capacitance chambers 32 and 34, each chamber having a flexible membrane inside and having four variable cavities C1, C2, C3 and C4. For the fixed chamber 32, the capacitance in the variable cavity C1 is inversely proportional to the capacitance in the variable cavity C2. Similarly, for the fixed chamber 34, the capacitance in the variable cavity C3 is inversely proportional to the capacitance in the variable cavity C4.

In pairs 32 and 34 of the two chambers, one fixed capacity chamber 32 or 34 pumps fluid to the filter / dialysis machine, while the second fixed capacity chamber 32 or 34 filters equal volume of fluid. It is provided to be lifted from the dialysis machine. Therefore, the compatible flow rate balancer or balance chamber 30 ensures that the fluid coming in through the balancer 30 is in turn removed from the balancer 30 and the net fluid increase or loss to the patient is zero. Cavities 32 and 34 are alternated in each stroke so that fluid is lifted to and from the patient, resulting in a stable, or non-pulsatile, flow profile.

Cavities 32 and 34 operate on inlet valves 36 and outlet valves 38, which are arranged alternately to achieve the flow equalization described above. In particular, these valves are configured such that one of the chamber pairs 32 or 34 contains dialysate flowing from regulator 16 through line 18 and fills one of cavities C2 or C4. This filling action reduces the volume of the corresponding one of the cavities C1 or C3, and the post-use dialysate or used dialysate that fills the cavities C1 or C3 in the previous stroke is output from line 22 to the output pressure balancer 24. Drain to line 40 through the blood leak detector 26 and flow resistance 28. When this operation occurs, the dialysate pressure pump 42 draws the used dialysate from the filter / dialyzer 44 and through the pressure regulating recirculation loop 46 to the other flow chamber vs. 32 or 34, the used dialysate. Extrude. Pump 42 pushes the fluid into one of the variable used dialysate cavities C1 or C3.

As the amount of used dialysate in the variable chamber increases, the same amount of fresh dialysate that fills the variable cavity C2 or C4 in the previous process inevitably decreases, pushing this fresh dialysate toward the patient. .. Fresh dialysate is extruded from line 48 through the output pressure balancer 24, the first ultrafilter 52, part of the filtration line 88, the second ultrafilter 54, and the dialysate monitoring multi-tube 56. The brands of suitable ultrafilters are listed below. From the diversified tube 56, fresh filtration fluid flows through the three-way bypass valve 58, from the bypass valve through line 60 into the filter / dialysis machine 44, or out of replenishment port 86, on filtration line 88. It flows through the rest to the blood circuit 70.

As shown, the second outlet of the bypass line 62 extends from the bypass valve 58 and into the line 64 of the post-dialysis machine, leading to the pressure regulating recirculation loop 46 or, according to another method, cleaning. It extends into line 66 and leads to outlet 40 through wash valve 68. Bypass line 62, wash line 66 and wash valve 68 allow various system components to be washed or cleaned before the start of treatment.

The blood circuit 70 includes an arterial approach line 72 and a venous approach line 74. The arterial approach line 72 includes a Y connection 76 that connects to the dialysate input line described below. The arterial line 72 transports blood from the patient 78 to the arterial infusion chamber 80. Blood is transported through the extracorporeal circuit 70 by the peristaltic blood pump 82. Pump 82 pumps blood from the arterial line through the drip chamber 80 to the blood inlet of the dialysis machine 44. Blood is pumped through the membrane contained within the dialysis machine, toxins and waste products are diffusely transported from the blood, transported from the output of the dialysis machine 44 into the venous drip chamber 84, and venous approach line 74. It is transported back to patient 78 through.

Other parts of the pre-dialysis machine dialysate line 60, dialysate 44, post-dialysis machine line 64 and dialysate flow path 20 are maintained at a pressure below the blood pressure in circuit 70, resulting in dialysis of waste products. Convective transport is performed from the membrane within device 44, and waste products and other unwanted substances are transported from the patient's blood. System 10 can perform additional or alternative hemofiltration, in which case the solution is along filtration line 88, replenishment port 86, microfilter / ultrafilter 90, post-filter line 92, It flows directly to the blood circuit 70 through the replenisher pump 94 and the pre / post dilution fluid multi-tube 100.

Further, referring to FIG. 2 in connection with FIG. 1, the pre- / post-diluted multi-diversified tube 100 is shown in detail. The filter 90 according to one embodiment is a microfilter. One suitable microfilter is the Pall® Gelman® disposable 0.22 μm filter. In another embodiment, the filter 90 is an ultrafilter. One suitable reusable ultrafiltration is the Medica® Diapure® 28 filter. One suitable disposable ultrafilter is the Medica® 150 filter. In general, microfilters differ from ultrafilters in the ability of various filters to remove small particles. In general, ultrafilters can remove relatively small particles compared to microfilters. For the purposes of the present invention, the term "microfilter" refers to the size of membrane micropores or membrane openings of about 1000 to about 10.5Includes filters that are angstroms (Å), such filters that effectively filter particles such as red blood cells, yeasts, fungi, bacteria and certain proteins. As used herein, the term "ultrafiltration" includes filters in which the diameter or length of membrane micropores or membrane openings is about 10 to about 1000 Å, such filters. Effectively filters intracellular toxins (pyrogeneous substances), viruses and proteins. In a preferred embodiment, the ultrafilter used in the present invention has a micropore size range of about 10 to about 40 Å.

The filter 90 is an ultrafiltrationr 52 such that sterile or injectable quality fluid is pumped through the replenishment pump 94 and enters the post-dilution line 104 or pre-dilution line 106 through the Y connection 102. Works with and 54. The fluid is pumped through the Y connection 102 via the pump 94 into the post-dilution line 104 or the pre-dilution line 106. Cap 108 is shown removed from fitting 109 located at the end of pigtail 126 on line 106. The diversified tube 100 of another embodiment forms only the post-dilution line 104 and the pigtail 126, the rest of the line 106 is removed and the corresponding output from the Y-connector 102 is terminated by a cap 108. The rest of the line 106 can now be selectively added to the pigtail 126 by removing the cap 108. Once the pre-dilution line 106 is fully connected, the system 10 can perform either pre- / post-dilution HF or HDF as needed.

As shown in FIG. 1, the post-dilution line 104 extends into the intravenous drip chamber 84. The pre-dilution line 106, in one embodiment, extends to a rank 3 Y-connector or T-connector 76 located between the pump 82 and the drip chamber 80. In another embodiment, line 106 (shown by imaginary line) extends through solenoid valve 77 (shown by imaginary line) to a second Y-connector or T-connector 79 located within arterial approach line 72. The arterial approach line 72 is then supplied into the posterior pump line 73. Another embodiment is used for the rinseback function described below. As described in detail below, it is advantageous to connect the pre-dilution line 106 to the arterial approach line 72 via the connector 79 when the system 10 is associated with the bolus volume, prime and rinseback functions described below. However, pre-dilution therapy should also be evaluated to operate with connection to the arterial approach line 72 via connector 79 and to line 73 via connector 76.

The check valve 110 is located within the post-dilution line 104, allowing fluid to flow only in the direction of blood circuit 70 from pump 94, and blood flowing from lines 92 and 88 through filters 52 and 54, or dialysate flow path. Prevent backflow into 20 other parts. Similarly, the check valve 112 is located within the pre-dilution line 106 to prevent blood from flowing back from the pre-dilution line 106 into the dialysate flow path 20.

The post-dilution line 104 comprises a pinch clamp 114. The pre-dilution line 106 also comprises a pinch clamp 116. Suitable pinch clamps for System 10 are provided, for example, by the Medica® model M03122. Clamps 114 and 116 are electrically operated, pneumatically operated, or otherwise controlled by the microprocessor of System 10 to selectively open and close as specified for each treatment. The multi-vessel 100 of System 10 (i) opens valve 114 throughout treatment and only by closing valve 116 through post-dilution purification, (ii) opens valve 116 throughout treatment and valve 114. Only by closing the valve (iii) sequentially open the valve 114 while the valve 116 is closed, and then reverse this condition and the valve 114 is closed. By opening valves 116 in between, via pre-diluted purification mode and post-diluted purification mode, or (iv) by opening valves 114 and 116 simultaneously, through pre-diluted purification mode and post-diluted purification mode. Allows HF or HDF therapy to be performed.

Although not shown, when pre-dilution and post-dilution treatments are performed simultaneously, variable flow limiters should be placed on pre-dilution and / or post-dilution lines 106 and 104, respectively, to separate the flow rates of dialysate through lines 104 and 106. (For example, 80% flow through the post-dilution line 104 and the remaining 20% through the pre-dilution line 106). Therefore, the valves 114 and 116 may instead be puncture type valves that allow the desired percentage to selectively pass through lines 104 and 106. Alternatively, such a puncture valve is placed in combination with the on / off valves 114 and 116 so that the valve sets the flow rate limit and on / off control in both pre-dilution and / or post-dilution purification modes. be able to.

In one embodiment, the operator sets an overall target replenishment amount into the machine using the system 10. The operator then inputs the velocity or volume factor of the pre-diluted vs. post-diluted fluid flow. One replenishment pump 94 operates continuously. Clamps 114 and 116 are arranged alternately to achieve pre-dilution and post-dilution purification rates. In one example, if the desired rate breakdown is two-thirds post-dilution and one-third pre-dilution and the total flow rate is 150 ml / min, the post-dilution clamp is closed for 5 seconds and the pre-dilution clamp 116. Is open. This condition is then reversed, the pre-dilution clamp 116 closes and the post-dilution clamp 114 opens for the next 10 seconds. This sequence is repeated throughout the treatment, or at least in the part of the treatment that includes convective purification. According to another method, flow limiting means are placed on lines 104 and 106 to form the desired post-dilution two-thirds and pre-dilution one-third profiles, with valves 114 and 116 throughout the convection purification portion of the treatment. Open with.

The goal of bypassing part of the convection from post-dilution to pre-dilution is to prevent blood concentration, primarily when performing post-dilution therapy. Therefore, it is desirable that the valve does not circulate for an excessively long time so that such a condition does not occur. On the other hand, for wear and maintenance purposes, it is also desirable not to circulate the valve too often. The desired cycle time for the valve is selected to fit both of these factors.

(Bolus amount and rinse back function) Further referring to FIG. 1, a second primary embodiment of the present invention is not only to perform a priming sequence, but also to provide a bolus amount of fluid to the patient as needed and to perform a blood rinse back at the end of treatment. Includes the capabilities of System 10. The bolus amount function and the blood rinseback function will be described in order below.

(Injection of bolus amount) For example, to provide a patient with a certain bolus or fluid volume when the patient loses too much fluid from the patient's vasculature, the bypass valve 58 allows the dialysate to flow further into the predialysis machine line 60. Rather, it bypasses the filter / dialysis machine 44 and line 60 and is set to flow through bypass line 62 instead. The wash valve 68 is closed, the dialysate flowing through the line 62 is connected to the dialysate return line 64 in a T-shape, and the fluid passing through the compatible flow balancer 30 is shunted to the discharge port 40. The bypass valve 58 configuration has the effect of modifying the dialysate flow path 20 so that the dialysate flow rate bypasses the filter / dialyzer 44. As described above, the dialysate returning through line 64 circulates through the pressure regulating circulation loop 46 via the dialysate pump 42. The recirculation loop 46 serves to control the pressure at the inlet of the flow balancer 30. In particular, the recirculation loop 46 operates on the input pressure balancer 118 and the supply regulator 16. The feed pump 14 sets the pressure along line 18. The pressure in line 18 moves the diaphragm in the input pressure balancer 118 back and forth, limiting the orifices that form pressure in loop 46 or opening the orifices that reduce pressure in loops, resulting in , Circulate some fluid in loop 46.

The bypass valve 58 is deenergized so that the dialysate flows through the bypass line 62, the flow meter 50 is stopped, and the isolation valve 120 arranged in the post-dialysis machine line 64 is closed. Valves 58 and 120 completely isolate the filter / dialyzer 44 from the rest of the dialysate flow path 20. In order to generate the bolus amount while the filter / dialysis device 44 is isolated, the purge valve 122 is opened and discharged. At the same time, a portion of the fluid flowing from the flow balancer 30 to the bypass valve 58 flows through the filtration line 88 through the replenishment port 86, through the filter 90, the post-filter line 92, the replenishment pump 94 and the post-dilution line. Lifted through the IV chamber 84 via 104 (or pre-dilution line 106), the IV chamber 84 purges air from the solution and injectable quality bolus or fluid volume into the venous approach line 74. Allows flow to patient 78 through. The valve 122 is connected to an open fluid source, i.e., from the fluid being pumped through the cavities C1 and C3 of the flow balancer, the flow limiter 28, line 125 and line 126 (indicated by bidirectional arrows). An equal amount of fluid pumped by the pump 94 to the extrapolopeal circuit 70, as it is connected to an open fluid source through it, is injected into the system between the front and rear flow balancers of the balancer 30. be able to. The fluid flow passes through the valves 122 and then through the filters 52, 54 and 90 and is monitored for proper conductivity and temperature. Pump 94 shuts down if any of these measurements are out of the correct range.

The control scheme of System 10 can be manipulated to start the bolus amount manually or automatically. In one embodiment, the control scheme automatically initiates the bolus volume function after receiving the appropriate signal from a biosensor such as a blood sensor, blood volume sensor, electrolyte sensor, oxygen sensor, or any combination thereof. ..

It is important to note that the intermembrane pressure difference (TMP) alarm limit must be disabled or opened when the isolation valve is closed. The TMP alarm confirms that there is a positive pressure difference from the blood circuit 70 through the dialyzer 44 to the dialysate flow path 20 during normal operation, so that the net flow rate of the liquid is from the bloodstream to the dialysate. Up to the flow path 20. In addition, the TMP is monitored to detect pressure changes that may indicate a problem. When the isolation valve 120 is closed, the TMP in the dialysis machine 44 isolated between the valve 120 and the bypass valve 58 tends to equalize. However, since dialysis is performed at this point, such equalization is not a problem and no alarm is required.

The flow balancer 30 requires an equal volume of fluid to flow from line 18 to the balancer as the capacitance flows from the recirculation loop 46 to the balancer 30. Since a certain amount of fluid is supplied to the patient, the fluid cannot be withdrawn from the patient with the dialyser 44 isolated, compared to the amount of fresh fluid supplied from the source 12 to the flow balancer 30. It should be evaluated that there is little fluid returning to the flow balancer 30 through line 62. Therefore, a fluid replenishment source is needed. For example, if the supply pump 14 supplies 300 ml / min to the flow balancer 30 and 100 ml / min is withdrawn from the replacement port 86 to the patient, then only 200 ml / min is bypass line 62, post-dialysis machine line 64, recirculation. It returns to the flow rate balancer 30 through the loop 46. The returning fluid is 100 ml / min deficient for 300 ml / min, which is widely supplied via the source 12, and such deficiency causes the flow balancer 30 to operate improperly.

To supply additional fluid, the purge valve 122 operated by the ultrafilter 52 is opened when injecting the bolus amount as described above. Purge valves 122 and 124 typically operate on ultrafiltrations 52 and 54, respectively, allowing the filters to be cleaned prior to treatment. Opening the purge valve 122 allows additional required fluid, such as an additional 100 ml / min, to be drawn from lines 125 and 126 into the dialysate flow path 20. The liquid drawn from the discharge line 126 previously flowed through the dialysis machine 44, passed through the flow balancer 30, and then was pumped to the discharge port 40. Therefore, the additional fluid drawn from line 126 must be sterilized and of injectable quality. Filters 52 and 54, as well as an additional disposable filter 90 in the filtration line 88, meet this requirement. That is, fluid entering system 20 through the purge valve 122 exits replenishment port 86 after passing through ultrafiltrations 52 and 54, passes through a third ultrafilter or microfilter 90, and finally patient 78. To. The filters 52 and 54 are, in one embodiment, disposable filters having a large surface area. The disposable filter 90 may be an ultrafilter or a microfilter. With the three filters in series, System 10 is triple redundant for bolus volume injection during normal operation.

As a special safety measure, if for some reason the replenisher fluid drawn from drain line 126 and passing through both filters 52 and 54 does not produce a solution of injectable quality, dialysate conductive probe, temperature sensor, The dialysate monitoring multi-purpose tube 56 including the flow sensor and dialysate pressure converter activates an alarm after turning off the replenishment pump 94. When the alarm is activated and the replenishment pump 94 is stopped, the configuration of the peristaltic pump 94 is that the rotating head clamps the tubing off a position along the tubing that wraps around the pump head and the fluid at that position. It is a configuration that effectively stops the flow.

To supply the bolus volume, the replenishment pump 94 pumps the bolus volume into the IV chamber 84 through a check valve such as the check valve 110 on the post-dilution line 104. It should be evaluated that the pre-diluted and post-diluted multi-diversified tubes 100 do not necessarily have to carry out the bolus volume solution function of the present invention. However, the amount of bolus solution can be carried out via the pre-diluted and post-diluted multi-diversified tubes 100 described above. Therefore, the pinch clamp 114 is opened so that the bolus amount penetrates the check valve 110 and passes through the clamp 114 and moves to the drip chamber 84 via the line 104, or the pinch clamp 116 is opened. The amount of bolus passes through the check valve 112, passes through the clamp 116, and moves to the drip chamber 80 via the line 106. From the drip chamber 80 or 84, the bolus volume is transferred to patient 78 via the venous approach line 74.

The bolus amount is predetermined or set by the operator, for example, via a touch screen control device, after the bolus amount function is started. In one embodiment, the bolus amount is set in the machine using the system 10 via a keypad on the touch screen. The amount of bolus can be controlled, for example, by monitoring the rotation speed of the replenishment pump 94 or by lifting with one of the biosensors described above until the desired setting is obtained. After the bolus volume has been supplied to the patient, the isolation valve 120 opens, the purge valve 122 closes, the bypass valve 58 is urged, and the dialysate flows through the predialysis machine line 60 instead of line 62. Can be done. Opening valves 120 and 58 reestablishes fluid communication with the dialysis machine 44. The TMP limit is reset or restarted accordingly. The UF flow meter 50 moves one stroke before the isolation valve 120 opens, and when the isolation valve 120 opens, it is possible to promote the generation of an intermembrane pressure difference. This procedure helps to achieve the UF goals set for the patient.

(Blood rinse back) The blood rinse-back function of the present invention operates in a manner similar to the bolus amount injection function described above. The amount of blood rinseback can be set at the beginning of the procedure or preset according to the prescription or treatment plan. In addition, a touch screen having a keypad can be used to set the rinse-back amount. Although the rinse-back function can be initiated manually in one embodiment, the present invention also intends to automatically initiate the rinse-back function at the end of treatment. In addition, the blood rinseback procedure can be controlled by entering a set amount of fluid, but this function can be controlled via a blood detector located near the patient end of the venous approach line 74. The blood detector can detect if there is no more blood in the blood circuit 70 and automatically shut down the replenishment pump 94 accordingly.

Each of the above major steps for performing a bolus volume infusion procedure can also be performed for a blood rinseback procedure. Obviously, there are different procedures for different purposes, so this procedure is done at different times during treatment. The bolus volume function described above is initiated manually or automatically when the patient's blood pressure appears to be or is decreasing. A blood rinseback is performed at the end of treatment, pushing the blood remaining in the system back to patient 78. Nevertheless, both procedures involve using the isolation valve 120 and the bypass valve 58 to isolate the dialyzer 44 from the rest of the dialysate flow path 20. In addition, when the purge valve 122 is opened, an equal amount of fluid supplied to the patient 78 can be drawn into the dialysate flow path 20 through the discharge line 126, the filters 52, 54 and 90, resulting in a flow balancer. 30 works properly.

One difference between the bolus volume function and the blood rinseback procedure is the position where the blood rinseback volume is supplied to the extracorporeal circuit 70. As mentioned above, the bolus amount can be supplied to the IV chamber 84. On the other hand, the rinse-back amount is supplied to the end of the arterial approach line 72 marked by the Y-connector or T-connector 79, or at the location of the arterial approach line 72, pump 82, arterial infusion chamber. 80, dialysis apparatus 44, intravenous drip chamber 84 and finally fed in a position suitable for purifying blood in the arterial line 72 through the venous approach line 74 to the patient 78. The connector 79 is connected to the pre-dilution line 106 via a solenoid valve 77, allowing automatic control of the rinse-back function. Therefore, using the pre-diluted and post-diluted diversified tubes 100 in combination with the rinse-back function of System 10, the rinse-back amount is passed from the replenishment pump 94 through the Y-connector 102, before including the check valve 112 and pinch valve 116. It is intended to feed arterial approach line 72 at connector 79 through dilution line 106, line 106 and solenoid 77.

However, it should be evaluated that the multi-purpose tube 100 does not necessarily have to supply the rinse-back amount of the present invention. For example, fluid connections can be made manually by the operator or nurse. 1 and 2 show a cap 108 that connects to a fitting 109 located at the end of the pigtail 126. If a rinse-back amount is required, instead of using the existing pre-dilution line 106, the cap 108 is removed from the pigtail 126 fitting 109 and the refill line (not shown) is manually removed from the patient before the end of the pigtail 126 and It connects to connector 76 located in line 73, either by connecting to connector 79 on line 72, or, for example, by removing the cap from connection 76. In a preferred embodiment, the replenishment line will include a one-way valve or a check valve, eg, a check valve 112, at its end.

To manually connect the replacement line to connector 76 or 79, power off the blood pump 82 and remove the cap from connector 79 or separate the arterial approach line 72 of the catheter inserted into patient 78 from the arterial needle. Blood is not lost from the patient because the clamp is closed at the end of the arterial needle. The connector 76 or 79 is then connected to the replenishment line, which is also connected to the end of the pigtail 126. In yet another alternative embodiment, a luer connector with a rotating hub is provided at the end of the arterial approach line 72 in one embodiment and connects this line directly to a replacement line extending from the pigtail 126. After forming this connection, the rinseback amount is supplied as described above.

A known method of rinsing back is to separate the arterial approach line 72 from the arterial needle and then connect the saline bag to the arterial approach line 72. Then, the saline solution flows through the artery approach line 72 from the saline solution bag, and the saline solution is rinsed back or washed. Both the manual and automated embodiments described above allow the system 10 to eliminate the need for a separate saline or injectable solution source and provide a blood rinse back.

(Prime) The prime function of the present invention operates using the device described above in connection with FIG. 1 with respect to the bolus amount and rinseback function for prime the extracorporeal circuit 70 prior to treatment. The prime contains a certain amount of fluid, such as dialysate, that is supplied at the beginning of treatment and removes air from the extracorporeal circuit. The prime function is used within a system or with a system controller that can be actuated to receive operator input to initiate the supply of prime. Alternatively, the system or controller can be actuated to automatically initiate the supply of prime at the start of treatment. In one embodiment, the amount or volume of prime is entered by the operator when starting the supply of prime. The amount or volume can be predetermined prior to the start of treatment. According to another method, the quantity or capacity is supplied until no air is perceived in the extracorporeal circuit.

(UF flow meter) Next, with reference to FIGS. 3 to 7, another main embodiment of the present invention is shown. 3 and 4 show systems 150 and 160, respectively, which contain many of the same components as described above in relation to FIGS. 1 and 2, respectively. These components are designated by the same reference numerals as in FIGS. 1 and 2. The description of these elements, including the respective alternatives described above in relation to FIGS. 1 and 2, applies equally to similar reference numerals in FIGS. 3 and 4.

One of the major differences between the embodiments described in FIGS. 1 and 2 when compared to the systems 150 and 160 of FIGS. 3 and 4 is that the UF flowmeter 50 has been removed in FIGS. 3 and 4. That is. The function of the UF flowmeter shown in FIGS. 1 and 2 is to remove the fluid accumulated in the patient's body from the patient 78 over time between the patient's last treatment and the current treatment. One of the problems that arises with renal failure is that patients often lose some or all of their urinary function. The fluid that would otherwise be removed from the patient by urination is stored in the patient's blood and surrounding tissues. Therefore, the dialysis machine, and the infusion of a clean solution into the patient 78, acts to remove waste products and other unwanted substances from the patient 78, whereas the UF flow meter 50 is a fluid that the patient obtains during treatment. It acts to remove an additional amount of fluid equivalent to the amount from the patient.

The UF flow meter 50 operates in a manner similar to one of the chamber pairs 32 and 34 of the flow balancer 30. The UF flow meter 50 defines a fixed volume chamber 132 separated by a diaphragm into two alternating variable capacitance cavities C5 and C6. The fixed volume chamber 132 is formed in the size of the desired relationship to the matching volume chambers 32 and 34. The inlet valves 136 and 138 of the UF flow meter 50 can circulate with the inlet valve 36 and the outlet valve 38 of the flow balancer 30. For this method, a known amount of fluid is removed at each stroke or valve cycle. The valves 136 and 138 alternate so that the cavity C6 pushes the fluid previously drawn into the cavity C5 through one of the outlet valves 138, after which the valve fills the capacity of the cavity C5 previously filled. It fills the cavity C6 and switches to push through the other outlet valve 138.

The UF flowmeter 50 is an effective but relatively complex device. Also, failure of either valve 136 or 138 results in uncontrolled flow in the middle of the diaphragm cycle, resulting in patient overfiltration.

Another problem with System 10 shown in Figure 1 is that air can be trapped inside the ultrafilters 52 and 54. However, air can also be trapped inside the disposable filter 90, which is more likely than if the air enters the reusable filters 52 and 54. Another problem with system 10 is that the dialysate pump 42 is located directly in front of the UF removal line 134 and leads to the UF flow meter 50. This configuration can cause blockage of the UF meter 50. Also, the purge valves 122 and 124 are closed during normal treatment in System 10 so that there is no flow across the membranes of these filters (the operational flow through the filters is the inlet of the filters. From to the outside of the membrane inside the ultrafilter, through the walls of the membrane, inside the membrane outside the outlet of the ultrafilter). The material filtered in the filters 52 and 54 remains in the filter after treatment until the purge valves 122 and 124 are opened and a wash cycle is performed. That is, recent and intracellular toxins filtered by the membranes in the ultrafilters 52 and 54 remain inside such filters throughout the treatment period.

Another potential problem with System 10 in Figure 1 is that if one of the purge valves 122 and 124 is not functioning properly, the only way to detect it is to detect an increase or decrease in TMP. TMP errors that are not properly tested and diagnosed by the operator can cause errors in the patient's UF.

Then, referring to FIGS. 3 and 4, the above problem is solved by removing the UF flowmeter 50 and replacing it with the ceramic UP pump 140 in the dialysate flow path 20. Ultra-high purity dialysate for online HF and online HDF treatments uses a ceramic pump 140 downstream from a single purge valve 122 for system 150 in Figure 3, double purge valve 122 and for system 160 in Figure 4. This is possible by placing it downstream of 124. In each case, the purge valve is located downstream from one of the flush outlets 142 of the ultrafilter 52 or 54. Therefore, the fluid reaching the pump 140 is removed along the discharge line 126. As described below, the pump 140 is, in one embodiment, a ceramic rotary reciprocating piston pump, which is advantageous in that it does not establish fluid communication between the inlet and outlet of the pump. This pump configuration enables fail-safe and does not result in uncontrolled fluid flow.

It is even more advantageous if the ceramic pump 140 is located downstream of the purge valves 122 and 124. That is, in addition to isolating the pump inlet and outlet, thereby eliminating the possibility of UF error due to component failure, placing the pump 140 in the predialysis machine can block or damage the UF pump with organic material. Sex decreases. That is, the UF removed and discharged from the pump 140 is a clean or sterile solution from the production unit 12. Therefore, the possibility of UF error due to intracellular toxins and bacteria accumulating in the UF removal device is substantially reduced in the systems 150 and 160 of the present invention.

Also, since the pump 140 draws fluid from the cleaning outlets 142 of the filters 52 and 54, the systems 150 and 160 perform continuous cleaning along the outside of the membrane inside these filters. In the case of system 160 of FIG. 4, the purge valves 122 and 124 circulate 50%, for example for each valve, so that both filters 52 and 54 are cleaned and cleaned when treatment is performed. Cleaning along the outer surface of the membranes of the filters 52 and 54 also removes air from the filters continuously or semi-continuously during treatment. The pump 140 removes the fresh dialysate as UF, while the dialyzer 44 functions as described above, diffusing waste products from the patient's blood. Waste products are also removed by convective transport produced by injecting blood directly into the extracorporeal circuit 70. The waste product is then pumped through the equilibrium chamber 30 to the outlet via the dialysate pump 42. UF pumping of fresh dialysate by pump 140 does not alter the therapeutic effect of systems 150 and 160.

As mentioned above, one major advantage of using the ceramic rotary reciprocating piston pump 140 is that there is no fluid communication between the inlet and outlet of the UF pump 140. 5 to 7 show an embodiment of the UF pump 140, which is a rotary and reciprocating piston pump. 5 to 7 show the rotary reciprocating piston pump 140 in three states: the fluid inflow state of FIG. 5, the pause state of FIG. 6, and the outflow state of FIG. One suitable rotary reciprocating piston pump is supplied by Diener Precision Pumps in Embluff, Switzerland.

In FIGS. 5-7, valve 140 comprises a rotary chamber 142, which defines an opening 144 that accommodates the ends of rotary and reciprocating pistons 146. The end of the piston 146 comprises an arm 148 having a ball bearing type head 152, which is slidably housed in a coupling opening 154 that fluidly communicates with the opening 144. Since the chamber 142 rotates through a shaft 156 having a substantially vertical axis, the head 152 is supported by the outer wall of the coupling opening 154, thereby rotating the arm 148 and the shaft 146. Due to the angle of the shaft 146 with respect to the substantially vertical shaft 156, the head 152, the arm 148 and the shaft 146 also translate back and forth in the angular direction of the shaft 146 according to the rotational position of the coupling opening 154 as the chamber 142 rotates. .. As shown in FIG. 5, in the inflow state, the piston head 152 is pulled further away from the pump body 158 compared to the vertical distance between the piston head 152 and the body 158 in the outflow state of the pump 140 in FIG. .. The piston head 152 is correspondingly in an intermediate relative position away from the body 158 in the paused state of the pump 140 shown in FIG. Therefore, the rotation of the drive shaft 156 causes the shaft 146 to rotate and translate with respect to the fixed body 158.

The body 158 defines a port opening 162 that allows a lubricant, such as water, to lubricate the sliding engagement between the shaft 146 and the inner bore of the body 158. The body 158 also defines inlet and exit ports 164 and 166, respectively. The lower end of the shaft 146 defines the notch 168. The notch 168 in the inflow state of the pump 140 allows fluid to enter the pump chamber 170 through the inlet port 164. Importantly, there is no fluid communication between the pump chamber 170 and the outlet port 166 in the inflow state. In the paused state of pump 140 in FIG. 6, shaft 146 is rotated so that the notch 168 faces port 164 or 166 or does not have fluid contact, between the pump chamber 170 and the openings of ports 164 and 166. Do not contact the fluid. In the outflow state of the pump 140 of FIG. 7, the shaft 146 is rotated to a position where the notch 168 allows fluid communication between the pump chamber 170 and the outlet port 166. Importantly, there is no fluid communication between the pump chamber 170 and the inlet port 164 in the outflow condition.

During operation, when the shaft moves from the outflow state (FIG. 7) to the inflow state (FIG. 5), the capacity in the pump chamber 170 increases to create a vacuum and the fluid is drawn into the chamber 170. In the paused state (FIG. 6), the capacity in the pump chamber 170 is reduced from the capacity in the inflow state (FIG. 5), creating a positive pressure in the chamber 170. As the shaft 146 moves from the paused state (FIG. 6) to the outflow state (FIG. 7), the capacity in the chamber 170 is further reduced, pushing fluid out of the outlet port 166.

Because the inlet port 164 is not in fluid communication with the outlet port 166, the pump 140 is unable to carry uncontrolled UF flow in the event of a failure or power loss, and the prior art flowmeter 50 and this flowmeter 50 Compared to the error inherent in its own valves 136 and 138, the potential for inherent error is significantly reduced, as is the potential UF error that can result from the failure of one of the purge valves 122 and 124.

As implied above, the amount of ultrafiltration fluid removed from the patient is controlled in one embodiment by monitoring the rotation speed of the shaft 146. The rotary reciprocating piston pump 140 is inherently accurate. However, if desired, a flow measuring device can be placed within the discharge line 126 to monitor the outlet of pump 140.

Pump 140 is the embodiment described above in connection with FIGS. 1 and 2 and is used for each of the embodiments including pre-dilution and post-dilution functions, bolus volume function and rinse back purge. In particular, FIGS. 3 and 4 can use the above-mentioned diversified pipe 100 related to FIG. 1, but are not shown for clarity. To inject the bolus amount and the rinseback amount, the pump 140 rotates in the opposite direction to draw the fluid from the line 126 indicated by the double-headed arrow in FIGS. 3 and 4 as above.

(Filtration configuration) The present invention of FIGS. 1 and 4 shows an improved filtration configuration. To produce a replacement solution suitable for patient 78, an electrolyte solution such as dialysate is filtered through an ultrafilter and / or microfilter to produce an injectable quality product. The present invention uses three filters in series and there is no pump intervening between the filters. Each filter adds a continuous log reduction of bacteria and intracellular toxins. When placed between filters, the pump is a place of accumulation of bacteria and intracellular toxins during downtime, such as when the system is powered off. Therefore, the present invention eliminates the need to place pumps between series filters. However, it should be appreciated that in addition to the pump, sensors and other flow components are intended to be placed between series filters.

In an attempt to eliminate as much bacteria and intracellular toxins as possible, the system of the invention shown in FIGS. 1 and 4 uses three series filters, namely filters 52, 54 and 90. These filters help ensure the quality of the solution by providing a continuous logarithmic reduction of bacteria and intracellular toxins. Filters 52, 54 and 90 may be in combination with disposable or reusable ultrafilters, microfilters or other intracellular toxin / bacteria reduction devices such as clarigen dial guard columns. In one embodiment, the filters 52 and 54 are reusable and the hydraulic path 88 is configured to not have a complex hydraulic function such as a pump after the first filter in the system, as a result. The risk of bacterial and biofilm growth is reduced after the solution is first filtered. In one embodiment, the filter 90 is a disposable microfilter.

For proper log reduction, it is important to reduce the likelihood that the bacterium will grow and subsequently produce intracellular toxins. Therefore, the filtration configurations of FIGS. 1 and 4 do not use a pump between filters 52, 54 or 90. The flow of drug solution from filters 52 and 54 passes through sterile tubing (and possibly other flow components) to reach the inlet of the next filter. Due to the greater likelihood of biofilm formation on the more complex lumen surfaces of the flow components, only tubing is provided between the filters 52 and 54 in one embodiment for single dialysate monitoring. The dialysis tube 56 is arranged between the filters 54 and 90. Limiting the components between filters to only simple tubes (and perhaps sensor components) helps prevent bacteria from growing on complex surfaces and ensures the effectiveness of disinfection. ..

The purging function in the preparation phase of the drug solution system of the present invention also helps to remove bacteria or intracellular toxins that have grown since the last use of the machine. However, the simplified route between filters 52, 54 and 90 grows very little.

When pumps are placed before and after the filters 52, 54 and 90, the flow rate of fluid pumped through the filter, for example via dialysate pump 42, is the flow rate pumped to patient 78 via, for example, infusion pump 94. It is possible to do more. Therefore, the system of FIGS. 1 and 4 can be set so that the drug solution flowing to patient 78 is a small part (but potentially a large part) of the total flow rate flowing out of the filter. For example, if the system is used for hemofiltration and the replacement fluid for patient 78 is set to a flow rate of 250 ml / min, the flow rate flowing out of the filters 52, 54 and 90 may be 300 ml / min. The purpose of such excess flow is to prevent stagnant areas at the connection between the filter and the filtration line 88 within the reusable filter, which allows bacteria to stagnate during downtime. Helps prevent proliferation between filters 52 and 54 in device 54 or filtration line 88, or after filter 54.

By using the filter in the above manner, the filter generally only needs to filter dirt from the incoming medical solution, thus ensuring the quality of the replacement solution by reducing the logarithm of the filter. .. Moreover, if one of the filters fails, nevertheless, the resulting logarithmic reduction of the remaining filters is in most cases sufficient to provide a medical grade solution. In addition, the smooth, clean surface between the filters is easily and effectively sterilized, preventing growth during periods of inactivity. The filtration configurations described herein are particularly well suited for the systems of FIGS. 1 and 4, but this configuration is expressly intended for use in the other functions and inventions described in these drawings. Of course, it should be evaluated that it can be applied to many different types of infusion fluid flow forms and configurations.

It should be appreciated that various changes and modifications to the currently preferred embodiments described herein are apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the invention and without diminishing the intended benefits. Therefore, such changes and amendments are intended to be included in the appended claims.

<figref num="1">FIG. 1 shows a system and method according to the invention for providing pre-diluted and / or post-diluted HF / HDF purification modes, bolus volume for a patient, prime and / or blood rinse back volume for a patient.</figref><figref num="2">FIG. 2 shows an embodiment of a therapeutic fluid supply diversified tube used in the system and method shown in FIG.</figref><figref num="3">3 and 4 show the systems and methods according to the invention for removing the ultrafiltration fluid from the patient and filtering the medical therapeutic fluid.</figref><figref num="4">3 and 4 show the systems and methods according to the invention for removing the ultrafiltration fluid from the patient and filtering the medical therapeutic fluid.</figref><figref num="5">5-7 show an embodiment of an ultrafiltration pump used in the systems and methods shown in FIGS. 3 and 4.</figref><figref num="6">5-7 show an embodiment of an ultrafiltration pump used in the systems and methods shown in FIGS. 3 and 4.</figref><figref num="7">5-7 show an embodiment of an ultrafiltration pump used in the systems and methods shown in FIGS. 3 and 4.</figref>

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Document	Office	Kind	Date
10738446	United States of America	–	2003-12-16
73844603	United States of America	A	2003-12-16
2003738446	–	–	–
US20030738446	–	–	–

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2013-01-22	Transfer of reconsideration by examiner before appeal (zenchi)AppealA911	A911
2013-01-12	Written amendmentA521	A521
2012-09-13	Decision of refusalA02	A02
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2011-12-05	Notification of reasons for refusalA131	A131
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2010-07-08	Written request for extension of timeA601	A601
2010-04-26	Notification of reasons for refusalA131	A131

Medical fluid therapy flow control systems

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