WO2019158747A1

WO2019158747A1 - Cleaning device and method for cleaning heater-cooler units

Info

Publication number: WO2019158747A1
Application number: PCT/EP2019/053950
Authority: WO
Inventors: Matthias Otten
Original assignee: MAQUET CARDIOPULMONARY GmbH
Priority date: 2018-02-19
Filing date: 2019-02-18
Publication date: 2019-08-22

Abstract

A cleaning device connectable to a heater-cooler unit of a cardiopulmonary bypass system, the cleaning device is operable for cleaning one or more internal tanks, pumps and tubing of the heater-cooler unit. The cleaning device includes: a first tank configured to receive a fresh fluid and an additive that form a cleaning fluid; a first supply line fluidly connected to the first tank for delivering the fresh fluid to the first tank; a second tank configured to receive a cycled cleaning fluid from the heater-cooler unit, and configured to discard a waste fluid from the cleaning device; a dosing device configured to deliver the additive to the first tank, wherein the dosing device is connected to the first tank by a second supply line; a first connection line fluidly connected to the first tank and that is fluidly connectable to the heater-cooler unit; a second connection line fluidly connected to the second tank and that is fluidly connectable to the heater- cooler unit; an optional third connection line fluidly connecting the second tank to the first connection line; and a control unit electronically connectable to the heater-cooler unit to establish electronic communication with the heater-cooler unit. The control unit is configured to control the flow of fluid in the first supply line, the first connection line, the second connection line and the optional third connection line (when present), and the movement of additive in the second supply line, in order to clean one or more internal tanks, pumps and tubing of the heater- cooler unit.

Description

Cleaning Device and Method for Cleaning Heater-Cooler Units

Field of the Disclosure

[0001] The field of the present disclosure pertains to that of cleaning devices and methods for cleaning heater-cooler units, particularly those relating to cardiopulmonary bypass systems.

More specifically, the present disclosure pertains to cleaning devices that operate to clean heater- cooler units with minimal operator involvement, and to more expeditious and efficient methods of cleaning heater-cooler units. A cardiopulmonary bypass system in accordance with this disclosure includes heart-lung machines, extracorporeal membrane oxygenation (ECMO) apparatuses, and pump assisted lung protection (PALP) apparatuses.

Background of the Disclosure

[0002] During cardiac surgery, heater-cooler units are used to control the patient’ s body temperature by means of heating and/or cooling the blood flow of an extracorporeal blood circuit and to apply thermal cardioplegia. Heater-cooler units include tubing, pumps and tanks containing temperature-controlled water that is provided to external heat exchangers or to warming/cooling blankets through closed water circuits. Because the water circuits are closed, the water in the circuits and the heater-cooler units does not come in contact with the blood of the patient.

[0003] Heater-cooler units and heater units are used in sensitive sterile environments, such as operation theatres. During cardiovascular procedures in on-pump cardiac surgery, the heater- cooler unit is applied to cool down a patient during an intervention (in order to reduce the metabolic rate and oxygen consumption for organ protection), to warm up the patient to a physiological temperature when the intervention is completed, as well as to keep a favored temperature constant during cardiopulmonary bypass surgery. The temperature transfer occurs via a heat exchanger in the coolant flow circuit and/or in the cardioplegia water circuit, and/or via a warming/cooling blanket. [0004] Some heater-cooler units have been shown to harbor and spread microbes, especially mycobacteria, which can lead to fatal infections. Therefore, cleaning cycles have been traditionally used to clean the heater-cooler units, wherein the units are taken off-line and their internal tanks, tubing and pumps are manually filled with disinfectants to reduce the number of microbes in the heater-cooler units.

[0005] However, one disadvantage of performing these cleaning cycles is that they are a frequent, time-consuming process. Because cleaning of a heater-cooler unit is currently performed manually by an operator, and more than three man-hours of time is typically required to perform the cleaning process, the cleaning process is labor intensive. Also, because recovery and multiplication of surviving microbes shortly after the end of a cleaning cycle is common, regular (e.g., weekly) cleaning cycles are typically performed. Thus, the cleaning of heater- cooler units is currently an overly time-consuming process for hospitals, especially those having multiple heater-cooler units.

[0006] Thus, there is a need in the art for an improved method of cleaning heater-cooler units in a more expeditious and efficient way. There is a further need for a cleaning device for a heater- cooler unit that will operate to clean the heater-cooler unit with minimal operator involvement.

Summary of the Disclosure

[0007] A non-limiting device is disclosed herein that constitutes a cleaning device for a heater- cooler unit. In accordance with a non-limiting illustrative embodiment of such a device, a cleaning device connectable to a heater-cooler unit of a cardiopulmonary bypass system, wherein the cleaning device is operable for cleaning or rinsing one or more internal tanks, pumps and tubing of the heater-cooler unit, is described that includes: (a) a first tank configured to receive a fresh fluid and an additive that form a cleaning fluid, wherein the first tank includes a first plurality of level sensors operable to detect a fluid level of at least one of the fresh fluid or the cleaning fluid within the first tank; (b) a first supply line fluidly connected to the first tank for delivering the fresh fluid to the first tank, wherein the first supply line is configured to control the flow of fresh fluid into the first tank; (c) a second tank configured to receive a cycled cleaning fluid from the heater-cooler unit, and the second tank is configured to discard a waste fluid from the cleaning device, wherein the second tank includes a second plurality of level sensors operable to detect a fluid level of waste fluid within the second tank; (d) a dosing device configured to deliver the additive to the first tank, wherein the dosing device is connected to the first tank by a second supply line; (e) a first connection line fluidly connected to the first tank and that is fluidly connectable to the heater-cooler unit, wherein the first connection line is configured to control the flow of cleaning fluid into the heater-cooler unit; (f) a second connection line fluidly connected to the second tank and that is fluidly connectable to the heater- cooler unit, wherein the second connection tine is configured to control the flow of cycled cleaning fluid into the second tank; and (g) a control unit in electronic communication with the first plurality of level sensors and the second plurality of level sensors, wherein the control unit is electronically connectable to the heater-cooler unit to establish electronic communication with the heater-cooler unit. In accordance with this non-limiting embodiment of the device, the control unit is configured to control the flow of fresh fluid in the first supply line, the movement of additive in the second supply line, the flow of cleaning fluid in the first connection line, and the flow of cycled cleaning fluid in the second connection line in order to clean the one or more internal tanks, pumps and tubing of the heater-cooler unit when the first connection line and the second connection line are fluidly connected to the heater-cooler unit, based on fluid level data received from the first plurality of level sensors, fluid level data received from the second plurality of level sensors, and a fluid level within at least one internal tank of the heater-cooler unit. Various other non-limiting illustrative embodiments of the device are also disclosed herein.

[0008] A method is disclosed herein that constitutes a method of cleaning the one or more internal tanks, pumps and tubing of a heater-cooler unit. Such a non-limiting illustrative embodiment of such a method of cleaning comprises the steps of: fluidly connecting an embodiment of the cleaning device of this disclosure to the heater-cooler unit; and operating the cleaning device such that the one or more internal tanks, pumps and tubing of the heater-cooler unit are cleaned. Various other non-limiting embodiments of this method are also disclosed herein.

[0009] A method is disclosed herein that constitutes a method of rinsing the one or more internal tanks, pumps and tubing of a heater-cooler unit. Such a non-limiting illustrative embodiment of such a method of rinsing comprises the steps of: fluidly connecting an embodiment of the cleaning device of this disclosure to the heater-cooler unit; and operating the cleaning device such that the one or more internal tanks, pumps and tubing of the heater-cooler unit are rinsed. Various other non-limiting embodiments of this method are also disclosed herein.

Brief Description of the Drawings

[0010] Figure 1 is a schematic illustration of a cleaning device connectable to a heater-cooler unit of a cardiopulmonary bypass system, in accordance with a non-limiting illustrative inventive embodiment of the present disclosure.

[0011] Figure 2 is a schematic illustration of a control unit of the cleaning device of Figure 1 employed to receive and send data from components of the cleaning device of Figure 1.

[0012] Figure 3 is a partial schematic illustration of the second connection line of another non limiting illustrative inventive embodiment of a cleaning device connectable to a healer-cooler unit of a cardiopulmonary bypass system of this disclosure.

Detailed Description of Illustrative, Non-limiting Inventive Embodiments

[0013] Various illustrative, non-limiting embodiments of this disclosure are described as follows with reference to the drawings, in which like parts are designated with like character references.

[0014] Figure 1 shows a cleaning device 100, which is connectable to a heater-cooler unit 200 of a cardiopulmonary bypass system. In Figure 1, the cleaning device 100 is connected to the heater-cooler unit 200. The cleaning device 100 is operable for cleaning one or more internal tanks 210, pumps 230 and tubing 220 of the heater-cooler unit 200. In Figure 1, the schematic representation of the one or more internal tanks 210, tubing 220 and pumps 230 is merely an illustration of the arrangement of such elements within a heater-cooler unit 200, and the cleaning device of the present disclosure is in no way limited to cleaning a heater-cooler unit 200 having such an internal arrangement of these elements. That is, the quantity and arrangement of these elements (internal tanks, tubing and pumps) within the heater-cooler unit may vary among different heater-cooler units; however, the cleaning device of the present disclosure can still be utilized to clean one or more internal tank(s), pump(s) and tubing of heater-cooler units having these different quantities and arrangements of these elements (internal tanks, tubing and pumps).

[0015] The cleaning device 100 includes a first tank 101. The first tank 101 includes a first plurality of level sensors 109, which operate to detect a fluid level within the first tank 101. In accordance with an embodiment of this disclosure, the first tank 101 includes at least four level sensors 109, and in the non-limiting embodiment shown in Figure 1, the first tank 101 includes four level sensors 109. In other embodiments of this disclosure, the first tank 101 includes one, two or three level sensors 109.

[0016] The first tank 101 receives fresh fluid via a first supply line 104, which is fluidly connected to the first tank 101, and which is configured to control the flow of fresh fluid into the first tank 101. For example, in the non-limiting embodiment shown in Figure 1, the first supply line 104 includes a fluid flow controller 105 and an optional fluid flow sensor 106, which operates to measure a flow rate of the fresh fluid in the first supply line 104. Fluid flow sensor 106 is primarily employed for handling flow error. In accordance with some embodiments of this disclosure, the fluid flow controller 105 is a two-way valve. In some embodiments of this disclosure, additional fluid flow sensors may be included in the different lines of the cleaning device 100 to measure the flow rates in the different lines. In certain embodiments of this disclosure, the fresh fluid employed in the cleaning device 100 is water-based, such as primarily sterile, filtered water; sterile, filtered saline; or other sterile and/or filtered electrolyte solution.

In the non-limiting embodiment shown in Figure 1, the first supply line 104 is connected to a source 300 of sterile, filtered water, or other suitable fresh fluid.

[0017] The cleaning device 100 also includes a dosing device, which is configured to deliver an additive to the first tank 101, and is connected to the first tank 101 by a second supply line 107. The additive may be in any form, such as a fluid or a solid ( e.g ., a powder). The additive is added to the fresh fluid in the first tank to form a cleaning fluid, which is used to disinfect or descale the one or more internal tanks, pumps and tubing of the heater-cooler unit 200. For example, the additive may be a descaling fluid, such as a 2% citric acid solution, or an antimicrobial fluid, such as a solution of chloramine-T ( e.g ., CLORINA®).

[0018] In the non-limiting embodiment shown in Figure 1, the dosing device is a third tank 103, which contains an additive fluid and is fluidly connected to the first tank 101 by the second supply line 107. In Figure 1, the second supply line 107 includes a fluid pump 108, which pumps the additive fluid from the third tank 103 to the first tank 101. In accordance with other embodiments of this disclosure, the dosing device is a dosing head attached to a container containing the additive in powder form. In such other embodiments, the dosing head allows for and controls the movement of the additive powder from the container to the first tank 101 via the second supply line.

[0019] The cleaning device 100 also includes a second tank 102, which is configured to receive cycled cleaning fluid from the heater-cooler unit 200, and configured to discard waste fluid from the cleaning device 100. As used herein,“cycled cleaning fluid” refers to that cleaning fluid or rinsing fluid disposed within, or exiting, the heater-cooler unit during the cleaning process. For example, in the non-limiting embodiment shown in Figure 1, the cleaning device 100 includes a second-tank inlet line 111 and a second-tank outlet line 112. The second-tank inlet line 111 is fluidly connected to the second tank 102, and is reversibly fluidly connectable to the heater- cooler unit 200. The second-tank inlet line 111 includes a fluid flow controller 113, which is operable for controlling the flow of fluid from the heater-cooler unit 200 into the second tank 102. In some embodiments of this disclosure, the fluid flow controller 113 is a two-way valve. The second-tank outlet line 112 is fluidly connected to the second tank 102, and includes a fluid pump 114, which pumps waste fluid out of the second tank 102 to be discarded from the cleaning device 100. For example, in the non-limiting embodiment shown in Figure 1, the waste fluid is sent to a drain 115 via the second-tank outlet line 112. As used herein,“waste fluid” refers to the fluid disposed within, or exiting, the second tank of the cleaning device.

[0020] The second tank 102 includes a second plurality of level sensors 110, which operate to detect a fluid level of waste fluid within the second tank 102. In accordance with an embodiment of this disclosure, the second tank 102 includes at least three level sensors 110, and in the non- limiting embodiment shown in Figure 1, the second tank 102 includes three level sensors 110. ln other embodiments of this disclosure, the second tank 102 includes one or two level sensors 110.

[0021] The cleaning device 100 also includes a first connection line 116, which is fluidly connected to the first tank 101 and is reversibly fluidly connectable to the heater-cooler unit 200. The first connection line 116 is configured to control the flow of cleaning fluid into the heater- cooler unit 200. For example, in the non-limiting embodiment shown in Figure 1, the first connection line 116 includes a fluid pump 117, a fluid flow controller 118 located downstream of the fluid pump 117, and a first recirculation branch 119. The first recirculation branch 119 fluidly connects the fluid flow controller 118 to the first tank 101. The fluid flow controller 118 operates to direct the fluid flowing therethrough into either the first recirculation branch 119 and back to the first tank 101, or into the first connection line 116 for use in cleaning the heater- cooler unit 200. Thus, when the fluid flow controller 118 directs the flow of fluid flowing therethrough into the first recirculation branch 119, the cleaning fluid within the first tank 101 can be recirculated, such as for example, in order to more completely mix the fresh fluid and the additive fluid within the first tank 101 as a result of the energy provided by the returning flow.

In some embodiments of this disclosure, the fluid flow controller 118 is a three-way valve. In accordance with some embodiments of this disclosure, any of the fluid flow controllers of the cleaning device 100 are at least one of chemically resistant and low-flow resistant.

[0022] The cleaning device 100 also includes a second connection line 121, which is fluidly connected to the second tank 102 and is reversibly fluidly connectable to the heater-cooler unit 200. In accordance with some embodiments of this disclosure, the second connection line is reversibly fluidly connectable to an external tube of the heater-cooler unit, such that the external tube of the heater-cooler unit can also be cleaned by the cleaning device. The second connection line 121 is configured to control the flow of cycled cleaning fluid into the second tank 102. For example, in the non-limiting embodiment shown in Figure 1, the second connection line 121 is reversibly fluidly connectable to an external tube 221 of the heater-cooler unit 200, and includes a fluid flow controller 122 and a second recirculation branch 123. The second recirculation branch 123 is fluidly connected to the fluid flow controller 122 and is reversibly fluidly connectable to an external tube 223 of the heater-cooler unit 200. The fluid flow controller 122 operates to direct the cycled cleaning fluid flowing therethrough into either the second recirculation branch 123 or into the second connection line 121. Thus, when the fluid flow controller 122 directs the flow of cycled cleaning fluid flowing therethrough into the second recirculation branch 123 and the second recirculation branch 123 is fluidly connected to the external tube 223 of the heater-cooler unit 200, the cycled cleaning fluid within the heater-cooler unit 200 can be recirculated, such as for example, during the method of cleaning the one or more internal tanks, pumps and tubing of the heater-cooler unit 200. In some embodiments of this disclosure, the fluid flow controller 122 is a three-way valve.

[0023] In the non-limiting embodiment shown in Figure 1, the cleaning device 100 includes the second connection line 121, which is separate and distinct from the first connection line 116. Thus, the cleaning fluid going to the healer-cooler unit (in the first connection line 116) does not come in contact with the cycled cleaning fluid coming from the heater-cooler unit (in the second connection line 121) during the cleaning process. In other words, the heater-cooler unit 200 is detachably disposed between the first connection line 116 and the second connection line 121 in a manner that keeps their flows separate. Therefore, any risk of renewed contamination of the heater-cooler unit during the cleaning process is greatly minimized in accordance with the design of the cleaning device 100.

[0024] In some embodiments of this disclosure, the cleaning device 100 also includes an optional third connection line 124, which is fluidly connected to both the second tank 102 and the first connection line 116. The third connection line 124 is configured to control the flow of cleaning fluid into the second tank 102. For example, in the non-limiting embodiment shown in Figure 1, the second tank 102 is configured to receive the cleaning fluid from the first tank 101, and the third connection line 124 includes a fluid flow controller 125. The fluid flow controller 125 operates to control the flow of cleaning fluid from the first tank 101 and the first connection line 116 into the second tank 102. Thus, when the fluid flow controller 125 controls the flow of cleaning fluid flowing therethrough into the second tank 102, the cleaning fluid within the first tank 101 can be drained into the second tank 102, as may be needed during operation of the cleaning device 100. Then, as waste fluid within the second tank 102, it can be discarded from the cleaning device 100. In accordance with some embodiments of this disclosure, the fluid flow controller 125 is a two-way valve. [0025] The cleaning device 100 also includes a control unit 130, which is in electronic communication with the first plurality of level sensors 109 and the second plurality of level sensors 110, and which is electronically connectable to the heater-cooler unit 200 to establish electronic communication with the heater-cooler unit, as shown schematically in Figure 2 (with the control unit 130 electronically connected to the heater-cooler unit 200). As used herein, the term“electronic communication” refers to the connection of elements, directly or wirelessly, for the transmission of electronic data from one element to the other element, or between the elements. Thus, the control unit 130 can receive fluid level data signals from the first plurality of level sensors 109 and the second plurality of level sensors 110 during the process of cleaning the one or more internal tanks 210, pumps 230 and tubing 220 of the heater-cooler unit 200. When the control unit 130 is electronically connected to the heater-cooler unit 200, the control unit 130 can also receive data signals from the heater-cooler unit 200 indicating, for example, a fluid level within at least one internal tank 210 of the heater-cooler unit 200, the status of the heater-cooler unit 200 during the cleaning process, and/or any other desired process variables from the heater- cooler unit 200 for the cleaning process.

[0026] The control unit 130 may be located within a housing 131 of the cleaning device 100, or on top of or attached to the housing 131, or located remotely from the housing 131, or located within a separate housing on the heater-cooler unit 200, or a combination of these configurations. In the non-limiting embodiment shown in Figure 1, the control unit 130 is located within the housing 131 of the cleaning device 100. In any of these locations, the control unit 130 may be directly connected to the first plurality of level sensors 109, the second plurality of level sensors 110 and the heater-cooler unit 200 via at least one data transmission cable between the respective elements, or the control unit 130 may be wirelessly connected to these elements, such as for example, via a Groupe Special Mobile (GSM), Bluetooth, or wireless local area network

(WLAN) connection.

[0027] The control unit 130 is operable for controlling the flow of fresh fluid through the first supply line 104, the movement of additive through the second supply line 107, the flow of cleaning fluid through the first connection line 116, the flow of cycled cleaning fluid through the second connection line 121, and the flow of cleaning fluid through the optional third connection line 124 (when present). For example, in the non-limiting embodiment shown in Figure 1, the first supply line 104 includes a fluid flow controller 105 and a fluid flow sensor 106; the second supply line 107 includes a fluid pump 108; the first connection line 116 includes a fluid pump 117 and a fluid flow controller 118 located downstream of the fluid pump 117; the second connection line 121 includes a fluid flow controller 122; and the third connection line 124 includes a fluid flow controller 125. In the non-limiting embodiment shown in Figure 1, the control unit 130 is in electronic communication with each of these fluid flow controllers, fluid pumps and the fluid flow sensor, as illustrated schematically in Figure 2. Thus, the control unit 130 can receive fluid flow rate data signals from the fluid flow sensor 106, and can send electronic control signals to each of these fluid flow controllers and fluid pumps in order to control the flow of fluid in the respective line, during the process of cleaning the one or more internal tanks 210, pumps 230 and tubing 220 of the heater-cooler unit 200. In Figure 1, the direction of the flow of fluid within the respective lines is indicated by arrows on the respective lines.

[0028] In a certain embodiment of the control unit 130, the control unit comprises an input and/or output unit 150 for the input of information by an operator and/or for the output of information to the operator. The input and/or output unit 150 is illustrated schematically in Figure 2, where it is located within a separate housing on top of the heater-cooler unit 200 and is in electronic communication with the rest of the control unit 130 and the heater-cooler unit 200. For example, the output information may include status indicators as to the progress of the cleaning method and/or the status of the elements (e.g., fluid flow controllers, fluid pumps, etc.) within the cleaning device 100, and possible error messages to indicate an incorrect fluid and/or electrical connection. The input information preferably includes control data by means of which the operator can control the cleaning device 100. For example, the input information may include the particular type and model of the heater-cooler unit 200 to be cleaned, and an acknowledgement that the cleaning device 100 has been completely and correctly connected to the heater-cooler unit 200 by the operator. The control unit 130 is, in accordance with an embodiment, configured to clean different types and models of the heater-cooler unit 200. Therefore, the control unit 130 is preferably programmed to control the flow of cleaning fluid through the different lines of the cleaning device 100 at different times and rates, depending upon the particular type and model of the heater-cooler unit to be cleaned. Thus, based on the operator input as to the particular type and model of the hcatcr-coolcr unit 200, the control unit 130 can then control a cleaning process particular for that type and model of heater-cooler unit 200. In accordance with some embodiments of this disclosure, the input and/or output unit 150 is designed as a touchscreen, such that only one single unit is required for input and output, and this single unit can be operated by the operator easily and intuitively. Thus, input errors are avoided and a simple handling is achieved.

[0029] In the non-limiting embodiment of the cleaning device 100 wherein the cleaning device 100 further comprises the second-tank inlet line 111 and the second-tank outlet line 112, the second-tank inlet line 111 includes the fluid flow controller 113 and the second-tank outlet line 112 includes the fluid pump 114. In this embodiment, the control unit 130 is operable for controlling the flow of cycled cleaning fluid through the second-tank inlet line 111 and the flow of waste fluid through the second-tank outlet line 112, and is also in electronic communication with the fluid flow controller 113 and the fluid pump 114, as shown schematically in Figure 2. Thus, the control unit 130 can send electronic control signals to the fluid flow controller 113 and the fluid pump 114 in order to control the flow of cycled cleaning fluid in the second-tank inlet line 111 and the flow of waste fluid in the second-tank outlet line 112, respectively, during the process of cleaning the one or more internal tanks 210, pumps 230 and tubing 220 of the heater- cooler unit 200. Therefore, the control unit 130 is further configured to control the flow of cycled cleaning fluid in the second-tank inlet line 111, and the flow of waste fluid in the second- tank outlet line 112 in order to clean the one or more internal tanks 210, pumps 230 and tubing 220 of the heater-cooler unit 200 when the first connection line 116 and the second connection line 121 are fluidly connected to the heater-cooler unit 200.

[0030] When the first connection line 116 and the second connection line 121 are fluidly connected to the heater-cooler unit 200 for cleaning the one or more internal tanks, pumps and tubing of the heater-cooler unit 200, the control unit 130 receives fluid level data from the first plurality of level sensors 109 and the second plurality of level sensors 110 during the cleaning process, as shown schematically in Figure 2. The control unit 130 may also receive fluid level data from one or more level sensors 209 located in the internal tank 210 during the cleaning process, as also shown schematically in Figure 2. In the non-limiting embodiment of the cleaning device 100, wherein the first supply line 104 includes the fluid flow sensor 106, the control unit 130 also receives fluid flow rate data signals from the fluid flow sensor 106, as shown schematically in Figure 2. Based on such fluid level data from the plurality of level sensors 109 and 110, the fluid level data from the one or more level sensors 209 when present, and the fluid flow rate data from the fluid flow sensor 106 when present, the control unit 130 is configured to control the flow of fresh fluid in the first supply line 104, the flow of additive fluid in the second supply line 107, the flow of cleaning fluid in the first connection line 116, the flow of cycled cleaning fluid in the second connection line 121, and the flow of cleaning fluid in the optional third connection line 124 when present, in order to clean the one or more internal tanks 210, pumps 230 and tubing 220 of the heater-cooler unit 200. Of course, the flow of cleaning fluid in the third connection line 124, when present, is employed to dispose of unused, excess cleaning fluid that will not be used to clean the one or more tanks 210, pumps 230 and tubing 220 of the heater-cooler unit 200. In addition, in the non-limiting embodiment of the cleaning device 100 wherein the cleaning device 100 further comprises the second- tank inlet line 111 and the second-tank outlet line 112, the control unit 130 is also configured to control the flow of cycled cleaning fluid in the second-tank inlet line 111 and the flow of waste fluid in the second- tank outlet line 112 in order to clean the one or more internal tanks 210, pumps 230 and tubing 220 of the heater-cooler unit 200.

[0031] In accordance with another non-limiting embodiment of this disclosure, the second connection line 121 further includes therein an additional fluid flow controller 142 and an additional recirculation branch 143, and an additional fluid flow controller 152 and an additional recirculation branch 153, wherein the three fluid flow controllers 122, 142, 152 are arranged in parallel in the second connection line 121, as shown schematically in Figure 3. The additional recirculation branch 143 is fluidly connected to the additional fluid flow controller 142 and is reversibly fluidly connectable to an external tube 243 of the heater-cooler unit 200, and that portion of the second connection line 121 including the additional fluid flow controller 142 is reversibly fluidly connectable to an external tube 241 of the heater-cooler unit 200. The additional recirculation branch 153 is fluidly connected to the additional fluid flow controller 152 and is reversibly fluidly connectable to an external tube 253 of the heater-cooler unit 200, and that portion of the second connection line 121 including the additional fluid flow controller 152 is reversibly fluidly connectable to an external tube 251 of the heater-cooler unit 200. In Figure 3, the additional recirculation branches 143, 153 are fluidly connected to the external tubes 243, 253, respectively, of the hcatcr-coolcr unit 200, and the additional portions of the second connection line 121 are fluidly connected to the external tubes 241, 251 of the heater- cooler unit 200. The additional fluid flow controller 142 operates to direct the cycled cleaning fluid flowing therethrough into either the additional recirculation branch 143 or into the second connection line 121, and the additional fluid flow controller 152 operates to direct the cycled cleaning fluid flowing therethrough into either the additional recirculation branch 153 or into the second connection line 121. Thus, when the fluid flow controller 142 directs the flow of cycled cleaning fluid flowing therethrough into the additional recirculation branch 143 and the additional recirculation branch 143 is fluidly connected to the external tube 243 of the heater- cooler unit 200, the cycled cleaning fluid within the heater-cooler unit 200 can be recirculated via this additional pathway. Similarly, when the fluid flow controller 152 directs the flow of cycled cleaning fluid flowing therethrough into the additional recirculation branch 153 and the additional recirculation branch 153 is fluidly connected to the external tube 253 of the heater- cooler unit 200, the cycled cleaning fluid within the heater-cooler unit 200 can be recirculated via this additional pathway. In accordance with certain embodiments of this disclosure, the additional fluid flow controllers 142, 152 are three-way valves. Also, the control unit 130 is in electronic communication with the additional fluid flow controllers 142, 152, as shown schematically in Figure 2. Thus, the control unit 130 can send electronic control signals to the fluid flow controllers 142, 152 in order to control the flow of cycled cleaning fluid in the second connection line 121 during the process of cleaning the one or more internal tanks 210, pumps 230 and tubing 220 of the heater-cooler unit 200. In Figure 3, the direction of the flow of fluid within the respective lines is indicated by arrows on the respective lines.

[0032] In accordance with another non-limiting embodiment of this disclosure, the second connection line 121 further includes therein only one additional fluid flow controller 142 and only one additional recirculation branch 143, wherein the two fluid flow controllers 122, 142 are arranged in parallel in the second connection line 121. In such an embodiment, the additional fluid flow controller 142 and additional recirculation branch 143 would function in the same manner as described in the preceding paragraph regarding the embodiment shown in Figure 3. In other words, this embodiment does not include the fluid flow controller 152 and associated structures such as corresponding portions of the second connection line 121 and additional recirculation branch 153. [0033] ln accordance with this disclosure, a non-limiting embodiment pertaining to a method of cleaning one or more internal tanks, pumps and tubing of a heater-cooler unit, is provided wherein the method includes the steps of: fluidly connecting an embodiment of the cleaning device of this disclosure to the heater-cooler unit; and (b) operating the cleaning device such that the one or more internal tanks, pumps and tubing of the heater-cooler unit are cleaned.

[0034] For example, in a non-limiting embodiment of the method of this disclosure, the one or more internal tanks, pumps and tubing of the heater-cooler unit are cleaned with an embodiment of the cleaning device as shown in Figure 3. The first connection line 116 and second- tank inlet line 111 of the cleaning device 100 are fluidly connected to the heater-cooler unit in such a way that cleaning fluid can flow through the one or more internal tanks, pumps and tubing of the heater-cooler unit. Referring to Figure 3, the second recirculation branch 123 is fluidly connected to the external tube 223, and the portion of the second connection line 121 including the fluid flow controller 122 is fluidly connected to the external tube 221, wherein the external tubes 221, 223 of the heater-cooler unit 200 correspond to a first patient water circuit of the heater-cooler unit 200. The additional recirculation branch 143 is fluidly connected to the external tube 243, and the portion of the second connection line 121 including the fluid flow controller 142 is fluidly connected to the external tube 241, wherein the external tubes 241, 243 of the heater-cooler unit 200 correspond to a second patient water circuit of the heater-cooler unit 200. In addition, the additional recirculation branch 153 is fluidly connected to the external tube 253, and the portion of the second connection line 121 including the fluid flow controller 152 is fluidly connected to the external tube 251, wherein the external tubes 251, 253 of the heater- cooler unit 200 correspond to a cardioplegia water circuit of the heater-cooler unit 200.

[0035] The cleaning device 100 is then operated such that cleaning fluid, which can include, for example, a descaling fluid or an antimicrobial fluid, is circulated through the one or more internal tanks, pumps and tubing of the heater-cooler unit. In addition, since the external lubes 221, 223, 241, 243, 251, 253 of the heater-cooler unit 200 are fluidly connected to the cleaning device 100, the cleaning fluid is also circulated through these external tubes. The cleaning device is then operated for an appropriate amount of time, such as for example, 60 to 120 minutes, or 90 minutes, or other appropriate time period, in order to clean the one or more internal tanks, pumps and tubing and the external tubes of the heater-cooler unit. After the cleaning process, the cycled cleaning fluid can be removed from the heater-cooler unit 200 via the external tubes 221, 241, 251 and the second-tank inlet line 111.

[0036] At that point, the cleaning device 100 can also be used to rinse the one or more internal tanks, pumps and tubing and the external tubes of the heater-cooler unit. The cleaning device 100 is then operated such that rinsing fluid, such as, for example, the fresh fluid, is circulated through the one or more internal tanks, pumps and tubing, as well as the external tubes of the heater-cooler unit. After rinsing, the rinsing fluid can be removed from the heater-cooler unit 200 via the external tubes 221 , 241 , 251 and the second-tank inlet line 111. The rinsing procedure can be repeated several times, such as two or three times, to thoroughly rinse the one or more internal tanks, pumps and tubing and the external tubes of the heater-cooler unit.

[0037] In other words, the cleaning device 100 may be operated in a first mode using a cleaning fluid in order to clean the heater-cooler unit 200, and in a second mode using a rinsing fluid in order to rinse components of the heater-cooler unit 200 after cleaning and before use on a patient. In addition, in the embodiments of this disclosure wherein the cleaning device includes the third connection line 124, the cleaning device 100 may also be operated in a third mode wherein any unused, excess cleaning or rinsing fluid that will not be used to clean or rinse, respectively, the one or more tanks, pumps and tubing of the heater-cooler unit 200 can be drained from the first tank 101 into the second tank 102 via the third connection line 124.

[0038] As mentioned above, the first connection line 116, second connection line(s) 121, second recirculation branch(es) 123, 143, 153 and second-tank inlet line 111 may be reversibly fluidly connectable to the heater-cooler unit (200). This means that these fluid conduits are detachable from the heater-cooler unit 200. Various types of connections may be used to detachably connect these fluid carrying structures 116, 121, 123, 143, 153 and 111 to the heater- cooler unit 200 in order to detachably connect the cleaning device 100 to the heater-cooler unit 200 in a manner that permits cleaning fluid from the cleaning device 100 to flow into the heater- cooler unit 200 and clean the one or more tanks, pumps, and tubing of the heater-cooler unit 200. Examples of types of connections that may be employed for this purpose include threaded connections, non-threaded connections, and quick couplers, such as, e.g., HANSEN couplings. The possible locations of these connections 500 are shown in Figures 1 and 3, and any combination of different types of connections 500 may be used (i.e., the connections 500 do not need to all be the same type of connector).

[0039] While the present disclosure provides multiple exemplary embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of this disclosure. In addition, many modifications may be made to adapt a particular situation or material to the teachings of this disclosure without departing from the essential scope thereof. Therefore, it is intended that the invention, as defined in the appended claims, not be limited to any particular embodiment disclosed herein, but that the invention will include all embodiments falling within the scope of the claims. Also, in the drawings and the description, there have been disclosed exemplary embodiments and, although specific terms may have been employed, they are unless otherwise stated used in a generic and descriptive sense only and not for purposes of limitation. Moreover, the use of the terms first, second, etc. do not denote any order or importance, but rather the terms first, second, etc. are used to distinguish one element from another. Furthermore, the use of the terms a, an, etc. do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced item unless otherwise explicitly indicated. In addition, unless otherwise indicated, use of the term“about” shall indicate a range of ±10% around the stated base value or range.

Claims

Wc claim:

1. A cleaning device connectable to a heater-cooler unit of a cardiopulmonary bypass system, wherein the cleaning device is operable for cleaning or rinsing one or more internal tanks, pumps and tubing of the heater-cooler unit, the cleaning device comprising:

a first tank configured to receive a fresh fluid and an additive that form a cleaning fluid, wherein the first tank includes a first plurality of level sensors operable to detect a fluid level of at least one of the fresh fluid or the cleaning fluid within the first tank;

a first supply line fluidly connected to the first tank for delivering the fresh fluid to the first tank, wherein the first supply line is configured to control the flow of fresh fluid into the first tank;

a second tank configured to receive a cycled cleaning fluid from the heater-cooler unit, and the second tank is configured to discard a waste fluid from the cleaning device, wherein the second tank includes a second plurality of level sensors operable to detect a fluid level of waste fluid within the second tank;

a dosing device configured to deliver the additive to the first tank, wherein the dosing device is connected to the first tank by a second supply line;

a first connection line fluidly connected to the first tank and that is fluidly connectable to the heater-cooler unit, wherein the first connection line is configured to control the flow of cleaning fluid into the heater-cooler unit;

a second connection line fluidly connected to the second tank and that is fluidly connectable to the heater-cooler unit, wherein the second connection line is configured to control the flow of cycled cleaning fluid into the second tank; and

a control unit in electronic communication with the first plurality of level sensors and the second plurality of level sensors, wherein the control unit is electronically connectable to the heater-cooler unit to establish electronic communication with the heater-cooler unit;

wherein the control unit is configured to control the flow of fresh fluid in the first supply line, the movement of additive in the second supply line, the flow of cleaning fluid in the first connection line, and the flow of cycled cleaning fluid in the second connection line in order to clean the one or more internal tanks, pumps and tubing of the heater-cooler unit when the first connection line and the second connection line are iluidly connected to the heater-cooler unit, based on fluid level data received from the first plurality of level sensors, fluid level data received from the second plurality of level sensors, and a fluid level within at least one internal tank of the heater-cooler unit.

2. The cleaning device of claim 1, wherein the dosing device is a third tank fluidly connected to the first tank by the second supply line.

3. The cleaning device of claim 1 or claim 2, further comprising a third connection line fluidly connecting the second tank to the first connection line, wherein the third connection line is configured to control the flow of cleaning fluid into the second tank from the first connection line;

wherein the second tank is configured to receive the cleaning fluid from the first tank; and

wherein the control unit is further configured to control the flow of cleaning fluid in the third connection line in order to clean the one or more internal tanks, pumps and tubing of the heater-cooler unit when the first connection line and the second connection line are fluidly connected to the heater-cooler unit, based on fluid level data received from the first plurality of level sensors, fluid level data received from the second plurality of level sensors, and a fluid level within at least one internal tank of the heater-cooler unit.

4. The cleaning device of any one of the preceding claims, wherein the first connection line includes a first fluid pump, a first fluid flow controller located downstream of the first fluid pump, and a first recirculation branch;

wherein the first recirculation branch fluidly connects the first fluid flow controller to the first tank;

wherein the first fluid flow controller is operable for directing the cleaning fluid flowing therethrough into the first recirculation branch or into the first connection line; and

wherein the control unit is in electronic communication with the first fluid pump and the first fluid flow controller.

5. The cleaning device of any one of the preceding claims, wherein the second connection line includes a second fluid flow controller and a second recirculation branch;

wherein the second recirculation branch is fluidly connected to the second fluid flow controller and is fluidly connectable to the heater-cooler unit;

wherein the second fluid flow controller is operable for directing the cycled cleaning fluid flowing therethrough into the second recirculation branch or into the second connection line; and

wherein the control unit is in electronic communication with the second fluid flow controller.

6. The cleaning device of claim 5, wherein the second connection line further includes a third fluid flow controller and a third recirculation branch;

wherein the third recirculation branch is fluidly connected to the third fluid flow controller and is fluidly connectable to the heater-cooler unit;

wherein the third fluid flow controller is operable for directing the cycled cleaning fluid flowing therethrough into the third recirculation branch or into the second connection line;

wherein the control unit is in electronic communication with the third fluid flow controller; and

wherein the second fluid flow controller and the third fluid flow controller are arranged in parallel in the second connection line.

7. The cleaning device of claim 6, wherein the second connection line further includes a fourth fluid flow controller and a fourth recirculation branch;

wherein the fourth recirculation branch is fluidly connected to the fourth fluid flow controller and is fluidly connectable to the heater-cooler unit;

wherein the fourth fluid flow controller is operable for directing the cycled cleaning fluid flowing therethrough into the fourth recirculation branch or into the second connection line; wherein the control unit is in electronic communication with the fourth fluid flow controller; and

wherein the second fluid flow controller, the third fluid flow controller and the fourth fluid flow controller are arranged in parallel in the second connection line.

8. The cleaning device of any one of the preceding claims, wherein the first supply line includes a fifth fluid flow controller and a fluid flow sensor operable to measure a flow rate of the fresh fluid;

wherein the fifth fluid flow controller is operable for controlling the flow of fresh fluid into the first tank;

wherein the control unit is in electronic communication with the fifth fluid flow controller and the fluid flow sensor; and

wherein the control unit is configured to control the flow of fresh fluid in the first supply line, the movement of additive in the second supply line, the flow of cleaning fluid in the first connection line, the flow of cycled cleaning fluid in the second connection line, and the flow of cleaning fluid in the third connection line in order to clean the one or more internal tanks, pumps, and tubing of the heater-cooler unit when the first connection line and the second connection line are fluidly connected to the heater-cooler unit, based on fluid level data received from the first plurality of level sensors, fluid level data received from the second plurality of level sensors, the fluid level within at least one internal tank of the heater-cooler unit, and fluid flow rate data received from the fluid flow sensor.

9. The cleaning device of any one of claims 3 to 8, wherein the third connection line includes a sixth fluid flow controller, wherein the sixth fluid flow controller is operable for controlling the flow of cleaning fluid from the first tank into the second tank, and wherein the control unit is in electronic communication with the sixth fluid flow controller.

10. The cleaning device of any one of the preceding claims, further comprising:

a second-tank inlet line fluidly connected to the second tank and that is fluidly

connectable to the heater-cooler unit, wherein the second-tank inlet line includes a seventh fluid flow controller; and

a second-tank outlet line fluidly connected to the second tank, wherein the second-tank outlet line includes a second fluid pump;

wherein the seventh fluid flow controller is operable for controlling the flow of cycled cleaning fluid from the heater-cooler unit into the second tank; wherein the control unit is in electronic communication with the seventh fluid flow controller and the second fluid pump; and

wherein the control unit is further configured to control the flow of cycled cleaning fluid in the second-tank inlet line, and the flow of waste fluid in the second-tank outlet line in order to clean the one or more internal tanks, pumps and tubing of the heater-cooler unit when the first connection line and the second connection line are fluidly connected to the heater-cooler unit.

11. The cleaning device of any one of claims 2 to 10, wherein the second supply line includes a third fluid pump, and wherein the control unit is in electronic communication with the third fluid pump.

12. The cleaning device of any one of the preceding claims, wherein the first plurality of level sensors includes at least four level sensors.

13. The cleaning device of any one of the preceding claims, wherein the second plurality of level sensors includes at least three level sensors.

14. The cleaning device of any one of the preceding claims, wherein the fresh fluid is sterile, filtered water.

15. The cleaning device of any one of claims 4 to 14, wherein each of the first fluid flow controller, the second fluid flow controller, the third fluid flow controller, and the fourth fluid flow controller are three-way valves.

16. The cleaning device of any one of claims 8 to 15, wherein each of the fifth fluid flow controller, the sixth fluid flow controller, and the seventh fluid flow controller are two-way valves.

17. The cleaning device of any one of claims 2 to 16, wherein the additive is a descaling fluid or an antimicrobial fluid.

18. A method of cleaning one or more internal tanks, pumps and tubing of a heater-cooler unit, the method comprising:

fluidly connecting the cleaning device of any one of the preceding claims to the heater- cooler unit; and

operating the cleaning device such that one or more internal tanks, pumps and tubing of the heater-cooler unit are cleaned.

19. A method of rinsing one or more internal tanks, pumps and tubing of a heater-cooler unit, the method comprising:

fluidly connecting the cleaning device of any one of claims 1 to 17 to the heater-cooler unit; and

operating the cleaning device such that one or more internal tanks, pumps and tubing of the heater-cooler unit are rinsed.