Fluid distribution device

Abstract

A fluid distribution device includes a disposable housing and a disposable fluid connector connectable to a compatible panel connector of a control system. The fluid distribution device may also include two manifolds within the housing, the two manifolds being connected to each other via a plurality of fluid interconnectors, each of which is controllable by a valve system. One manifold may include a fluid inlet for receiving fluid from a panel connector, while the other manifold may include a plurality of fluid distribution ports adapted to establish fluid communication between the fluid interconnectors and fluid lines external to the fluid distribution device.

Description

[0001] Related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 020,047, filed May 5, 2020, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0003] In some embodiments of the present invention, the present invention relates to fluid management, and more particularly, but not exclusively, to a fluid distribution device. The fluid distribution device is particularly useful during mechanical ventilation through an endotracheal tube. Background Art

[0004] Mechanical ventilation is necessary to help patients who have difficulty breathing on their own. In the medical treatment of patients who need respiratory assistance, an endotracheal tube is usually inserted into the patient's trachea through the mouth, nose or any other surgically created opening (including tracheostomy). One end of the endotracheal tube is connected to a ventilator, which periodically forces air through the tube into the lungs. The distal end of the tube is usually provided with an inflatable cuff, which is inflated by conventional means after the tube is inserted into the trachea. The inflated cuff is assumed to provide a seal against the inner wall of the trachea.

[0005] To ventilate a patient, air is forced into the patient's lungs via a mechanical ventilation system. The forced air is transferred from the ventilator to the lungs via an endotracheal tube, which is connected to the ventilator tubing at its proximal end and has its distal end in the trachea above the keel flap. During exhalation, air flows back from the lungs through the tube. The endotracheal tube is inserted into the trachea to maintain an open air passage or to deliver oxygen and allow mucus to be suctioned out of the lungs.

[0006] The length of the endotracheal tube is designed so that the proximal end of the tube connects to a tube attached to the ventilator, while the distal end of the tube resides in the patient's trachea, past the vocal cords above the keel flap.

[0007] Recently, the mechanical ventilation industry and the endotracheal tube industry have independently introduced new brands with advanced features to improve the care of intubated patients.

[0008] U.S. Published Application No. 20140366874 (the contents of which are incorporated herein by reference) discloses a system for controlling and monitoring flow in a cuffed endotracheal tube device. A connector panel has three or more connectors for establishing fluid communication with the proximal ends of several lines of the endotracheal tube device. A processing unit instructs a control unit to perform various operations on each line. Summary of the Invention

[0009] According to one aspect of some embodiments of the present invention, a fluid distribution device is provided. The fluid distribution device comprises: a disposable housing and a disposable fluid connector that can be connected to a compatible panel connector of a control system. The fluid distribution device may also include a first manifold and a second manifold, each of the first manifold and the second manifold being mounted within the disposable housing and connected to each other via a plurality of fluid interconnectors, each of the fluid interconnectors being controllable by a valve system. The first manifold may include one or more fluid inlets for receiving fluid from one or more panel connectors, and the second manifold may include a plurality of fluid distribution ports suitable for establishing fluid communication between the fluid interconnectors and external fluid lines.

[0010] According to one aspect of some embodiments of the present invention, a fluid distribution device for mechanical ventilation is provided. The fluid distribution device comprises: a disposable housing; a disposable fluid connector that can be connected to a compatible panel connector of a control system, wherein the control system is used to control the flow in an endotracheal tube device. The fluid distribution device may also include a first manifold and a second manifold, each of the first manifold and the second manifold being mounted within the disposable housing and connected to each other via a plurality of fluid interconnectors, each of the fluid interconnectors being controllable by a valve system. The first manifold may include a fluid inlet for receiving fluid from one of the panel connectors, and the second manifold may include a plurality of fluid distribution ports suitable for establishing fluid communication between the fluid interconnectors and the fluid lines of the endotracheal tube device.

[0011] According to some embodiments of the present invention, the device second manifold is configured to establish separate flow paths to at least two different dispensing ports.

[0012] According to some embodiments of the present invention, the separate flow paths include a first fluid path between a first pair of fluid interconnectors and a first dispensing port, and a second fluid path between a second pair of fluid interconnectors and a second dispensing port.

[0013] According to some embodiments of the present invention, the second manifold is configured to establish separate flow paths to at least three different distribution ports.

[0014] According to some embodiments of the present invention, the separate flow paths include a first fluid path between a first pair of fluid interconnectors and a first distribution port, a second fluid path between a second pair of fluid interconnectors and a second distribution port, and a third fluid path between an additional fluid interconnector and a third distribution port.

[0015] According to some embodiments of the present invention, the disposable fluid connector comprises a disposable cuff inflation connector connectable to a compatible control panel cuff inflation connector. According to some embodiments of the present invention, the second manifold comprises a cuff inflation port for establishing fluid communication between the disposable cuff inflation connector and a cuff inflation line of the endotracheal tube device.

[0016] According to some embodiments of the present invention, the disposable fluid connector includes a disposable vacuum connector connectable to a compatible control panel vacuum connector. According to some embodiments of the present invention, the second manifold includes a vacuum port for establishing fluid communication between the disposable vacuum connector and a vacuum line, the vacuum line generating negative pressure in a waste collection container that receives waste fluid from the subject.

[0017] According to some embodiments of the present invention, the first manifold includes a waste port connectable to a waste line that delivers the waste fluid to the waste collection container.

[0018] According to some embodiments of the present invention, the first manifold includes a first fluid channel and a second fluid channel separated from each other. According to some embodiments of the present invention, the waste port of the first manifold is configured to be fed by fluid from the second fluid channel and is fluidically separated from the first fluid channel within the first manifold.

[0019] According to some embodiments of the present invention, the first manifold includes at least two separate fluid channels therein.

[0020] According to some embodiments of the present invention, the disposable fluid connector comprises a disposable fluid inlet connector connectable to a compatible gas supply panel connector of a control system. According to some embodiments of the present invention, the first fluid channel is in fluid communication with the disposable fluid inlet connector, and wherein the second fluid channel is fluidly separated from the disposable fluid inlet connector within the first manifold.

[0021] According to some embodiments of the present invention, the device comprises a saline inlet port connectable to a saline supply line. According to some embodiments of the present invention, the first fluid channel is configured to be fed with saline from the saline inlet port, and wherein the second fluid channel is fluidly isolated from the saline inlet port within the first manifold.

[0022] According to some embodiments of the present invention, the device includes a saline inlet port connectable to a saline supply line. According to some embodiments of the present invention, the first fluid channel is configured to be fed with saline from the saline inlet port, and wherein the second fluid channel is fluidly isolated from the saline inlet port within the first manifold.

[0023] According to some embodiments of the present invention, the valve system is external to the fluid interconnector.

[0024] According to some embodiments of the present invention, the valve system is external to the disposable housing.

[0025] According to some embodiments of the present invention, the valve system includes a plurality of movable press members, each press member aligned to engage a wall of one of the fluid interconnectors such that movement of the press member toward the corresponding wall generates a compressive force on the corresponding wall and restricts or stops flow through the corresponding fluid interconnector.

[0026] According to some embodiments of the present invention, the valve system includes a camshaft having a plurality of cams, each cam being aligned with one of the press members such that rotation of a cam creates linear motion of the corresponding press member.

[0027] According to one aspect of some embodiments of the present invention, there is provided a method of dispensing fluid in an endotracheal tube device, the method comprising connecting the device as described above, and optionally and preferably as described in further detail below, to a control system, and operating a controller of the control system to transmit a control signal to the valve system.

[0028] According to one aspect of some embodiments of the present invention, a system for controlling and monitoring flow in a cuffed endotracheal tube device is provided. The system comprises: a connector panel adapted to be connected to a disposable housing of a fluid distribution device and having a plurality of panel connectors adapted to be connected to disposable fluid connectors of the fluid distribution device; a valve system configured to selectively control flow within the fluid distribution device; and a controller configured to send control signals to the valve system. According to some embodiments of the present invention, the fluid distribution device comprises a first manifold and a second manifold, both mounted within the disposable housing and connected to each other via a plurality of fluid interconnects, each of the plurality of fluid interconnects being controllable by the valve system. According to some embodiments of the present invention, the first manifold comprises a fluid inlet for receiving fluid from one of the panel connectors, and wherein the second manifold comprises a plurality of fluid distribution ports adapted to establish fluid communication between the fluid interconnect and a fluid line of the endotracheal tube device.

[0029] According to one aspect of some embodiments of the present invention, a method for distributing fluid in an endotracheal tube device is provided. The method comprises connecting a fluid distribution device to a control system for controlling flow in the endotracheal tube device; and operating a controller of the control system to transmit a control signal to a valve system for controlling flow within the fluid distribution device. The fluid distribution device optionally and preferably comprises: a disposable housing; and a disposable fluid connector that is connectable to a compatible panel connector of the control system. The first manifold and the second manifold are both mounted within the disposable housing and connected to each other via a plurality of fluid interconnects, each of which is controllable by the valve system. According to some embodiments of the present invention, the first manifold comprises a fluid inlet for receiving fluid from one of the panel connectors, and wherein the second manifold comprises a plurality of fluid distribution ports adapted to establish fluid communication between the fluid interconnect and a fluid line of the endotracheal tube device.

[0030] According to some embodiments of the present invention, the valve system is external to the disposable housing.

[0031] According to some embodiments of the present invention, the disposable housing comprises a window exposing the fluid interconnect to allow the valve system to engage the fluid interconnect.

[0032] According to some embodiments of the present invention, the first manifold includes a waste port connectable to a waste line that delivers waste fluid to a waste collection container.

[0033] According to some embodiments of the present invention, the disposable fluid connector comprises a disposable vacuum connector connectable to a compatible control panel vacuum connector of the system. According to some embodiments of the present invention, the second manifold comprises a vacuum port for establishing fluid communication between the disposable vacuum connector and a vacuum line, the vacuum line generating negative pressure in the waste collection container.

[0034] According to some embodiments of the present invention, the control signal comprises a signal causing the valve system to open a fluid path from a fluid dispensing port to the waste port.

[0035] According to some embodiments of the present invention, the signal also causes the valve system to simultaneously open another fluid path from a panel connector of the control system to another fluid dispensing port.

[0036] According to some embodiments of the invention, the control signal comprises a signal causing the valve system to open a fluid path from a panel connector of the control system to one of the interconnectors and to open a fluid path from the interconnector to the waste port through another interconnector.

[0037] According to an aspect of some embodiments of the present invention, there is provided a valve system. The valve system comprises: a plurality of flexible wall interconnectors, and a plurality of movable pressing members. Each movable pressing member is optionally and preferably aligned to engage a wall of one of the interconnectors such that movement of the pressing member toward the corresponding wall generates a compressive force on the corresponding wall and restricts or stops flow through the corresponding interconnector. The valve system may further comprise a camshaft having a plurality of cams, each cam being aligned with one of the pressing members such that rotation of the cam establishes linear motion of the pressing member.

[0038] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as those of ordinary skill in the art to which the present invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present invention, exemplary methods and / or materials are described below. In the event of a conflict, the patent specification (including definitions) shall prevail. In addition, materials, methods, and examples are illustrative only and are not necessarily limiting.

[0039] The implementation of the method and / or system of the embodiments of the present invention may involve performing or completing selected tasks manually, automatically, or a combination thereof. In addition, actual instruments and devices according to embodiments of the method and / or system of the present invention may implement several selected tasks through hardware, through software, through firmware, or through the use of a combination of operating systems.

[0040] For example, the hardware for performing the selected tasks according to an embodiment of the present invention can be implemented as a chip or circuit. As software, the selected tasks according to an embodiment of the present invention can be implemented as multiple software instructions executed by a computer using any appropriate operating system. In an exemplary embodiment of the present invention, one or more tasks according to the exemplary embodiments of the method and / or system described herein are performed by a data processor, such as a computing platform for executing multiple instructions. Optionally, the data processor includes a volatile memory for storing instructions and / or data and / or a non-volatile memory for storing instructions and / or data, for example, a magnetic hard disk and / or removable media. Optionally, a network connection is also provided. A display and / or a user input device such as a keyboard or mouse are also optionally provided. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] Some embodiments of the present invention are described herein by way of example only and with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is emphasized that the details shown are by way of example and are intended to provide an illustrative discussion of the embodiments of the present invention. At this point, the description taken in conjunction with the drawings will make it apparent to those skilled in the art how to practice the embodiments of the present invention.

[0042] In the attached figure:

[0043] Figure 1 is a schematic diagram of a control system and a fluid distribution device for controlling flow in an endotracheal tube according to some embodiments of the present invention;

[0044] Figure 2A and 2B is the rear side of the fluid dispensing device according to some embodiments of the present invention ( Figure 2A ) and front side ( Figure 2B ) is a schematic diagram of an external perspective view;

[0045] Figure 3 is a schematic diagram of the interior of a fluid dispensing device according to some embodiments of the present invention;

[0046] Figure 4A -D is a schematic diagram of a first manifold according to some embodiments of the present invention, and in more detail, wherein: Figure 4A shows an isometric view, and 4B-D show Figure 4A Along line AA ( Figure 4B ), A'-A' line ( Figure 4C ) and A”-A” line ( Figure 4D ) cross-sectional view;

[0047] Figure 5 is a schematic diagram of representative examples of independent flow paths within a manifold according to some embodiments of the present invention;

[0048] Figure 6A - C is a schematic diagram of a valve system according to various exemplary embodiments of the present invention; and

[0049] Figure 7A -M is a schematic diagram showing several examples of fluid path fluid distribution devices according to some embodiments of the present invention. DETAILED DESCRIPTION

[0050] In some embodiments of the present invention, the present invention relates to fluid management, and more particularly, but not exclusively, to a fluid distribution device. The fluid distribution device is particularly useful during mechanical ventilation through an endotracheal tube.

[0051] Before explaining at least one embodiment of the present invention in detail, it should be understood that the present invention is not necessarily limited in its application to the details of construction and arrangement of components and / or methods set forth in the following description and / or shown in the accompanying drawings and / or embodiments. The present invention is capable of other embodiments or can be practiced or implemented in various ways.

[0052] The present embodiment includes a fluid distribution device. The fluid distribution device is useful in many applications where it is necessary to deliver fluid to and from a cavity. Preferably, but not necessarily, the fluid distribution device is used in a medical application, in which case the cavity is the inner cavity of a mammal (e.g., a human subject). For example, the fluid distribution device can be used during mechanical ventilation to provide fluid communication with a fluid line of an endotracheal tube device. Alternatively, the fluid distribution device can be used to provide fluid communication with a fluid line connected to other parts of the body (e.g., the abdominal space, a blood vessel, or the bladder). The fluid distribution device can be used to deliver fluid to and from the cavity of a hospitalized subject, for example, in an emergency room, during open surgery, etc.

[0053] When the fluid distribution device is used during mechanical ventilation, it may be used by a control system to control flow in a tracheal tube device, such as, but not limited to, an endotracheal tube device or a tracheostomy tube device.

[0054] When a fluid distribution device provides fluid communication with a blood vessel or bladder, it can aid in distributing fluids delivered to and from the body during various procedures such as, but not limited to, aspiration, pumping, irrigation, ventilation, and the like.

[0055] As used herein, "fluid" refers to any substance in liquid or gaseous state.

[0056] A representative example of a control system that can optionally utilize a fluid distribution device is the control system described in the aforementioned U.S. Published Application No. 20140366874, the contents of which are incorporated herein by reference. Such a control system can perform adjustable evacuation or suctioning of tracheal secretions, controlled irrigation and / or ventilation of the subglottic volume, and / or dynamic cuff sealing.

[0057] While the following embodiments particularly emphasize the use of a fluid distribution device during mechanical ventilation, it should be understood that some embodiments of the present invention utilize a fluid distribution device during other medical procedures and / or for other purposes.

[0058] The inventors have discovered that combining a fluid distribution device with a control system is beneficial because it reduces the maintenance complexity of the control system. In some embodiments of the present invention, the fluid distribution device is configured such that all fluid extracted from the endotracheal tube device passes through the fluid distribution device and not the control system. These embodiments advantageously eliminate the need to sterilize the control system between patients.

[0059] The fluid dispensing device is optionally and preferably entirely disposable so that it can be discarded with other hospital waste after use with an endotracheal or tracheostomy tube device.

[0060] Figure 1 A control system for controlling flow in an endotracheal tube device suitable for use with the fluid distribution device of this embodiment is shown. The control system is indicated by 100 and the fluid distribution device is indicated by 10.

[0061] The device 10 includes a housing 12 having a disposable fluid connector 14 and a fluid dispensing port 16. The housing 12 is preferably removably mounted on the system 100. A connector, such as a barb (not shown, see e.g., Figure 3 ), optionally and preferably mounted on each of the ports 16. The device 10 may also include a saline inlet port 18 having a connector 18a mounted thereon for connecting to a saline supply line 28 that provides saline from a saline source 29. The system 100 and device 10 are particularly useful for controlling and monitoring flow in a cuffed endotracheal tube device 102 having a main lumen 202, a cuff 210, a cuff inflation line 106c, and one or more additional fluid lines 106a, 106b. Two or more of the lines 106a-c, preferably each of the lines 106a-c, include a fluid connector (not shown) at their proximal ends that is compatible in shape and size with the connector of one of the fluid dispensing ports 16 to allow it to be connected to the corresponding connector of the fluid dispensing port, thereby establishing fluid communication between the corresponding line of the device 102 and the corresponding fluid dispensing port of the device 10. The connector of one of the dispensing ports (e.g., port 16d) is optionally and preferably compatible in shape and size with a fluid connector (not shown) at the proximal end of the retractable catheter 105, which is introduced into the main lumen 202 of the endotracheal tube device 102.

[0062] The connectors mounted on one or more dispensing ports 16 and the connectors at the proximal ends of the tubing 106a-c to be connected to the dispensing port 16 are optionally and preferably provided with matching colors to prevent misconnection. As a representative example, which should not be considered limiting, the connector of port 16a can have the same color as tubing 106a, so that when the device 10 is in use, the proximal connector of tubing 106a is connected to the connector of port 16a, the connector of port 16b can have the same color as tubing 106b, so that when the device 10 is in use, the proximal connector of tubing 106b is connected to the connector of port 16b. The connector of port 16c can have the same color as tubing 106c, so that when the device 10 is in use, the proximal connector of tubing 106c is connected to the connector of port 16c, and the connector of port 16d can have the same color as tubing 105, so that when the device 10 is in use, the proximal connector of tubing 105 is connected to the connector of port 16d.

[0063] System 100 and device 10 are suitable for use in conjunction with device 102 during any intubation procedure, including but not limited to oral, nasotracheal intubation, and tracheostomy.

[0064] In some embodiments of the present invention, the device 10 includes a waste port 20 having a connector 20a that can be connected to a waste line 22 to deliver waste fluid to a waste collection container 138, such as a capture bottle, having negative pressure therein. In these embodiments, the device 10 optionally and preferably includes a vacuum port 26 having a connector 26a that can be connected to a cleaning line 24 leading from an outlet 139 of the collection container 138. The outlet 139 can be provided with a mechanism, such as a floating member (not shown), to prevent the waste fluid from overflowing from the outlet 139, as is known in the art.

[0065] A more detailed description of the principles and operation of device 10 is provided below.

[0066] The system 100 includes a connector panel 108 having several panel connectors 132. Each panel connector 132 is optionally and preferably compatible in shape and size with one of the disposable fluid connectors 14 of the device 10 so that when the device 10 is mounted on the connector panel 108, the connector of the device 10 engages and matingly connects to the corresponding connector of the panel 108. The connector panel 108 may also include additional connectors for other operations, typically but not exclusively, those performed using negative pressure, such as but not limited to antibacterial toothbrushing and for draining secretions from the oropharynx. The panel 108 may optionally and preferably include additional connectors for connecting various filters, including but not limited to antibacterial filters and humidity filters. One or more connectors on the panel 108 are optionally and preferably controlled by an electro-optical switch (not shown), which can be configured to alarm in the event of a disconnection.

[0067] The connector 132 may include a gas (e.g., air) supply connector 172 for providing a flow of gas, for example, for ventilating a subglottic volume or a waste collection container 138. Figure 1 In FIG. 1 , the gas supply connector 172 is compatible in shape and size with the disposable fluid connector 14c.

[0068] The connector 132 may also include a vacuum connector 176 for connecting the device 10 to an external negative pressure line or vacuum pump, such as through a hospital's vacuum network. Alternatively, the system 100 may include a pump for providing vacuum conditions. The vacuum level is typically expressed in pressure units, where lower pressures correspond to higher vacuum levels and higher pressures correspond to lower vacuum levels. Figure 1In the embodiment, the vacuum connector 176 is compatible in shape and size with the disposable fluid connector 14a.

[0069] Optionally, the connector 132 also includes a cuff inflation connector 174 for providing a cuff inflation fluid (e.g., air, saline) specifically for inflating the cuff 210 via the cuff inflation line 106c. In these embodiments, one of the fluid dispensing ports 16 of the device 10, such as port 16c, is optionally and preferably in direct fluid communication with a disposable fluid connector of the device 10 that is connected to the cuff inflation connector 174 ( Figure 1 106b) and is connected to the proximal connector of tubing 106c when the device 10 is in use.

[0070] The system 100 optionally and preferably includes a power supply 112, which can be a medical grade isolated power supply. Alternatively, the system 100 can be connected to an external power supply unit (not shown). Preferably, power is distributed to the components of the system via a power distributor panel 114, which provides the appropriate voltage for each component. In some embodiments of the present invention, the system 100 includes an uninterruptible power supply (UPS) to ensure continuous operation of the system 100, for example, when it is necessary to disconnect the system from the main power supply for a short period of time or the main power supply is turned off. Any type of UPS can be used, such as one or more series of lithium-ion batteries, etc.

[0071] The system 100 preferably includes a processing system 116 and a control system 118. The control system may include a main controller 120 and one or more operating modules 122. The controller 120 and the operating modules 122 optionally and preferably have electronic circuits, wherein the electronic circuits of the controller 120 are configured to control the operation of the electronic circuit modules 122 in response to signals received from the processing system 116. Figure 1 As shown, systems 116, 118, and 120 may be provided as separate system units, or two or more of these systems may be combined into a single unit. Thus, for example, the main controller 120 of system 118 may also have processing capabilities, in which case system 118 also functions as system 116 and does not include a separate processing system. Below, references to processing unit 116 include both embodiments in which unit 116 is a separate system and embodiments in which system 118 also functions as a processing system.

[0072] Processing system 116 can be a general-purpose processor or a dedicated circuit and is configured to instruct the control system to perform the various operations described herein. The operations are based on algorithms that can be added to processing system 116. For example, the algorithms can be written to a tangible computer-readable medium, such as optical, magnetic, or non-volatile electronic memory accessible by processing system 116. Processing system 116 can also receive signals from system 118. In these embodiments, processing system 116 analyzes the signals transmitted by system 118 to extract information from the signals. Based on the extracted information, system 118 performs operations.

[0073] The extracted information may also be displayed on the display device 124 or sent via the I / O communication panel 126. The panel 126 may include one or more communication ports, such as a universal serial bus (USB) port, to allow the system 100 to connect to an external device, such as an external computer, an external hard drive, an external storage medium, an external monitor, an external personal device (e.g., a personal digital assistant (PDA), a smartphone, etc.), or any other device capable of communicating via a communication port such as a USB port. The panel 126 may include an RS232 connector for connecting to an external monitor. Other types of connectors, such as a PS2 port and a LAN port, are also contemplated. The panel 126 is configured to allow corresponding external devices to download data from the system 100 or upload data to the system 100. Representative examples of data that may be uploaded to the system 100 include, but are not limited to, software updates for the processing system 116 and historical data for a particular target. Representative examples of data that may be downloaded from the system 100 include, but are not limited to, parameters detected and / or calculated by the processing system 116.

[0074] Thus, the processing system 116 is optionally and preferably configured to communicate with other processing units or computers. Such communication may be wired communication, such as via a USB port, etc., and / or it may be wireless communication, such as Or WiFi communication, which can establish a connection between the system 116 and a remote location, for example, via the Internet. When the communication is wireless, the panel 126 includes suitable wireless communication means for establishing such communication.

[0075] System 116 may also be configured to communicate (via wired or wireless communications) with systems that are capable of receiving and processing data but may also have other functionality. Representative examples include, but are not limited to, cellular telephones with data processing functionality, personal digital assistants (PDAs) with data processing functionality, portable email devices with data processing functionality (e.g., devices), portable media players with data processing capabilities (e.g., Apple ), portable gaming devices with data processing capabilities (e.g. ). And a flat panel or touch screen display device with data processing function (for example, Apple ). System 116 may be configured to receive data from and send data to any of these systems.

[0076] The processing system 116 directs the control system 118, via the main controller 120, to perform operations according to program instructions corresponding to a proprietary algorithm designed by the inventors of the present invention. The processing system 116 is preferably also configured to record data calculated by the system 116 or received by the controller 120 or from an external source (via the panel 126) on a storage medium. Representative parameters that may be recorded by the system 116 include, but are not limited to, event time, cuff pressure, cuff leak, obstruction of one or more fluid lines, lung compliance, lung resistance, alarms, and one or more statistical analysis reports in the frequency domain or time domain related to monitored cuff pressure control, coughing, and other events.

[0077] The recorded data can be displayed on the display device 124, for example, upon a specific request by the operator. The recorded data can also be sent or downloaded to an external system having processing capabilities. The recorded data can also be used by the system 116 or a physician in various calculations or estimates that may require the use of pre-recorded data. For example, the recorded data can be used to analyze trends in lung compliance and resistance, thereby reducing the risk of abnormal lung conditions (e.g., acute respiratory distress syndrome, acute lung injury, ventilator-associated lung injury). Such analysis can include calculating the flow resistance in the main chamber of the device 102 based on the history of tracheal and ventilator pressures. The flow resistance is typically expressed in pressure units that describe the pressure drop along the length of the main chamber device 102. The resistance to flow history can be used to calculate lung compliance in order to warn of the development of ventilator-associated lung injury.

[0078] The system 116 can monitor and operate the controller 120, display data via the display 124, process a graphical user interface (GUI) displayed on the display 124, record the operation and alarms of the system 100, and / or send and receive data from external devices via the I / O communication panel 126. The data can be displayed graphically and / or in alphanumeric representation on the display 124. The system 116 is preferably configured to display visual messages, such as warning messages and system status messages, via the display 124. In some embodiments of the present invention, the system 100 includes an electro-acoustic device 130, such as a speaker or buzzer, for generating an acoustic signal in response to an electrical signal from the processing system 116. For example, the system 116 can be configured to accompany a warning message with an alarm signal.

[0079] The controller 120 and / or system 116 may optionally and preferably also receive input from a user interface system 128. The system 128 may include operating buttons and / or a touch screen to allow an operator to insert target details, select an operating profile, select a display mode, change profile parameters, and react to alarms, etc. The system 128 is preferably configured to allow an operator to override a procedure and / or bypass a procedure prescribed by the system 116. In various exemplary embodiments of the present invention, the display 124 may be provided as a touch screen to allow the display 124 to also function as a user interface system, in addition to or in lieu of operating buttons that the system 128 may or may not include.

[0080] The system 100 preferably also includes a valve system 180 controlled by the controller 120. According to the program executed by the controller 120, the valve system 180 allows selective fluid communication between the dispensing port 16 and the connector on the panel 108, and optionally and preferably also allows selective fluid communication between the dispensing port 16 and the saline inlet port 18 and the waste port 20. Preferably, the valve system 180 does not come into contact with the fluid passing through the corresponding ports. In some embodiments of the present invention, the valve system 180 is external to the device 10. For example, the housing 12 of the device 10 can be provided with a window 30 through which the valve system 180 engages and controls the fluid interconnects in the device 10, as described in more detail below.

[0081] In some embodiments of the present invention, the control system 118 performs operations including at least one of an irrigation procedure, an aspiration procedure, a cuff inflation procedure, a leak detection procedure, and a ventilation procedure based on, among other things, algorithms and using the valve system 180. This can be achieved by providing the system 118 with at least one of: an irrigation module 152 for performing an irrigation operation, an aspiration module 154 for performing an aspiration operation, a cuff inflation module 156 for performing a cuff inflation operation, a leak detection module 158 for performing a leak detection operation, and a ventilation module 160 for performing a deflation operation.

[0082] In some embodiments of the present invention, system 100 includes an additional suction module 155, which is generally used to automatically remove lung secretions from the lower portion of the trachea near or at the lungs. It should be understood that although modules 154 and 155 are shown as separate modules, this need not be the case, as for some applications, suction operations above and / or below the cuff may not necessarily be performed by separate modules. Therefore, in some embodiments, module 154 also performs the operations described herein with respect to module 155. In these embodiments, system 100 optionally includes only one suction module 154.

[0083] For any of the flushing, aspiration, leak detection, and ventilation operations, system 118 optionally and preferably automatically signals device 10 to select a fluid line from lines 106a and 106b and perform the corresponding operation through the selected line.

[0084] Modules 152, 154, 155, 156, and 160 may perform operations as described above in US Published Application No. 20140366874, the contents of which are incorporated herein by reference. Some operating principles of the modules of system 118 will now be explained.

[0085] The suction module 154 may include an adjustable pressure regulator and / or a flow meter (not shown). The pressure regulator controls the suction vacuum applied by the module 154, and the flow meter measures the flow rate generated by the suction operation. Regulating the suction vacuum is advantageous because it allows secretions to be suctioned with improved efficiency and reduces the risk of tissue damage. Measuring flow is advantageous because it allows determination of whether the corresponding fluid line is blocked, and optionally determines the level of blockage (e.g., percentage). This is preferably performed by the processing system 116, which receives flow rate data from the module 154 via the controller 120 and determines whether a blockage is present based on the flow rate data, and optionally also determines the level of blockage. This determination may include threshold processing.

[0086] Optionally, the suction module 154 also performs suction beneath the cuff to drain secretions, as described in further detail below.

[0087] Optionally, the suction module 154 can also be manually operated, for example, for draining oropharyngeal secretions using a separate suction conduit introduced externally into the main lumen of the device 102, and / or for providing negative pressure to a tooth brushing device for brushing the teeth while draining secretions from the oropharynx.

[0088] Flushing module 152 optionally includes a pump and is configured to introduce flushing fluid into one of lines 106a and 106b. Flushing module 152 is controlled by controller 120, which establishes fluid communication between flushing module 152 and one of lines 106a and 106b (e.g., by sending a signal to valve system 180), and then sends a signal to flushing module 152 to pump the flushing fluid. Controller 120 can select either line 106a or 106b for a flushing operation. During ventilation of the subject, there is preferably at least one time period during which controller 120 selects line 106a for a flushing operation and at least one time period during which controller 120 selects line 106b for a flushing operation.

[0089] The irrigation fluid may be of any type, including but not limited to a liquid, that includes an antiseptic substance, a biomarker substance, a local analgesic substance, and / or a secretion-diluting substance.

[0090] The cuff inflation module 156 may include one or more pressure sensors (not shown) that monitor the pressure within the cuff inflation line 106 c (and therefore within the cuff). Optionally and preferably, there is more than one pressure sensor for safety and to improve the accuracy of the measurement. For example, the module 156 may include two sensors, and the processing system 116 may compare the pressure values ​​measured by the two sensors and issue an alarm when the values ​​disagree (e.g., deviate from each other by 10% or more). The module 156 also includes a micropump that forces fluid (typically air) into the cuff inflation line 106 c and one or more valves that control the amount and rate of fluid delivered to the line 106 c or to deflate the cuff at a controlled rate.

[0091] The leak detection module 158 helps assess the level of seal provided by the cuff. This can be accomplished in more than one manner, for example, as described in U.S. Patent No. 6,843,250 and U.S. Published Application No. 20090229605, both of which are assigned to the same assignee as the present application and are incorporated herein by reference in their entireties as if fully set forth herein. Regardless of the technology used by the module to detect leaks, the main controller 120 preferably receives leak detection data from the module 158 and operates the cuff inflation module 156 in response to the data. For example, the controller 120 can instruct the module 156 to increase the pressure in the cuff when data from the module 158 indicates that a tubing leak has formed, and the controller 120 can decrease the pressure in the cuff when the data indicates that the cuff provides an adequate seal.

[0092] In some embodiments of the present invention, the controller 120 monitors changes in cuff pressure and operates the cuff inflation module 156 in response to the monitored pressure. The inventors have discovered that the subject's breathing may affect the pressure within the cuff. Therefore, the pressure change pattern can be analyzed based on periodicity and / or amplitude to maintain an adequate seal without over-inflating the cuff. According to some embodiments of the present invention, when the amplitude of the cuff pressure change is above a predetermined pressure threshold (typically from about 14 mmHg to about 16 mmHg, for example, about 15 mmHg) for a period of time above a predetermined time threshold (typically from about 15 minutes to about 25 minutes, for example, about 20 minutes), the controller 120 instructs the module 156 to preferably gradually reduce the cuff pressure.

[0093] The correlation between changes in cuff pressure and the subject's respiratory cycle is optionally and preferably also used to detect an obstruction in the cuff inflation line. In these embodiments, the controller 120 provides monitoring data related to cuff pressure as a function of time to the processing system 116. The system 116 analyzes the data and extracts respiratory features from the data, as described in further detail below. The present inventors have discovered that a lack of correlation between changes in cuff pressure and respiratory rate indicates that the cuff inflation line is obstructed. Therefore, according to some embodiments of the present invention, when the system 116 is unable to extract a respiratory feature from the cuff pressure data, or when the extracted feature does not correlate with a respiratory rate within a predetermined threshold (e.g., from 4 to 60 or from 10 to 20 breaths / minute for an adult, or from 20 to 40 breaths / minute for a child or infant), the controller 120 signals the ventilation module 160 to force air or other gas into the cuff inflation line 106c, thereby clearing the obstruction.

[0094] The module 155 may include a pressure regulator and / or a flow meter (not shown). The pressure regulator controls the aspiration vacuum applied by the module 155, and the flow meter measures the flow rate generated by the aspiration operation.

[0095] Patients connected to a ventilator require periodic removal of fluid from the trachea. Conventional practice in hospitals is to disconnect the ventilator from the patient and insert a retractable catheter 105 through the main lumen of the endotracheal tube, which is used to remove fluid from the trachea. The catheter 105 is introduced into the main lumen 202 of the device 102 so that its distal end is positioned outside the distal end 214 of the device 102 toward the lungs (according to the standard of care of 1-2 cm above the keel flap). The proximal end of the tubing 105 is connected to one of the fluid dispensing ports of the device 10 (e.g., port 16d).

[0096] The main controller 120 can synchronize the suction operation with the subject's respiratory cycle and / or tracheal pressure, wherein the module 155 performs a deep suction operation through the pipeline 105 based on data representing the respiratory cycle and / or tracheal pressure. The main controller 120 can send a signal to the module 155 to perform a deep suction operation during the exhalation phase of the respiratory cycle. The main controller 120 can dynamically update the negative pressure applied by the module 155 in response to the cuff pressure drop during exhalation. In an embodiment of the present invention, the main controller 120 adjusts the negative pressure so that the suction force generated remains approximately constant (e.g., within 20%) throughout the deep suction operation. The main controller 120 can adjust the negative pressure so that the effective negative pressure at the distal end of the pipeline 105 is about 0 mmHg to about 300 mmHg throughout the suction phase. This can be achieved by applying a pulsating high vacuum level, for example, every few respiratory cycles.

[0097] The following is a more detailed description of the principles and operation of the fluid dispensing device 10 according to some embodiments of the present invention, with reference to Figure 2A-7M .

[0098] Figure 2A and 2B is the rear side of the fluid dispensing device 10 according to some embodiments of the present invention ( Figure 2A ) and front side ( Figure 2B ). The rear side can be connected to a connector panel of a control system. In embodiments where the fluid dispensing device 10 is used during ventilation, for example and without limitation, the rear side can be connected to the connector panel 108 of the system 100 such that the disposable connector 14 connects to the panel connector 132, as further described above.

[0099] The fluid dispensing device 10 optionally and preferably includes a housing 12 from which a disposable connector 14 optionally protrudes. Optionally and preferably, a disposable connector 18a leading to a saline inlet port 18 also protrudes from the housing 12. The housing 12 can be opened using one or more clamps 32, such as snap-action clamps for opening and closing the disposable housing 12. Optionally and preferably, but not necessarily, the housing 12 is provided with reinforcing ribs 40 to further ensure the pressure resistance of the device. In some embodiments of the present invention, the housing 12 is shaped to allow for easy gripping, such as Figure 2B As shown by line 42. Preferably, the housing 12 is disposable. The housing 12 is optionally and preferably provided with a window 30 through which the valve system 180 engages and controls the fluid interconnectors in the device 10, as described below.

[0100] The housing 12 is optionally and preferably formed with dedicated areas 34, 36, 38 for attaching additional components (such as, but not limited to, instruction stickers, logos, etc.). Optionally and preferably, the device 10 includes an identification tag (not shown) that can be attached to one or more of the dedicated areas 34, 36, 38. The identification tag can be of any machine-readable type known in the art, such as, but not limited to, a barcode (e.g., a QR tag), RFID, and RTLS. Preferably, the walls of the housing 12 are thinner at the dedicated areas 34, 36, 38 to mark their locations for attaching the aforementioned additional components and to save material.

[0101] Figure 31 is a schematic diagram of the interior of the device 10, e.g., as viewed when the housing 12 is open. The device 10 preferably includes a first manifold 44 and a second manifold 46, both of which can be mounted within the housing 12. The fluid dispensing ports 16a-d described above, and optionally and preferably, the vacuum port 26, can be formed in the second manifold 46. A connector, such as, but not limited to, a barb, can be mounted on the second manifold 46 at each port 16a-d. These connectors are shown at 86a-d, respectively. The connectors 86a-d are optionally and preferably within the housing 12 and can be accessed by opening the housing 12 to connect to an external fluid line (e.g., a line of the endotracheal tube device 102). Alternatively, one or more of the connectors 86a-d can protrude from the housing 12, similar to the connector 18a.

[0102] Manifolds 44 and 46 are optionally connected to each other by a plurality of fluid interconnectors 48, each of which may be connected by a valve system 180 (not shown, see Figure 1 ) control. Specifically, each of the manifolds 44 and 46 may optionally include a plurality of interconnection ports, and the interconnector 48 is individually connected between the interconnection ports of the manifold 44 and the interconnection ports of the manifold 46. The interconnection ports of the manifold 44 are shown at 72 and 74, and the interconnection ports of the manifold 46 are shown at 76 and 78.

[0103] Preferably, interconnects 48 are connected between the interconnect ports of the manifolds in a one-to-one manner, i.e., each interconnect port of manifold 44 is connected to one interconnect port of manifold 46, such that the interconnect ports are paired between the manifolds. For example, a barb may be installed on each port of manifolds 44 and 46, wherein fluid interconnects 48 are compatible in shape and size with the barbs, and wherein each fluid interconnect 48 is connected between a barb of manifold 44 and a barb of manifold 46. The barbs of manifolds 44 and 46 are generally designated 54 and 56, respectively. Figure 3 Five interconnects and interconnect ports are shown for each manifold, but other numbers of interconnects and interconnect ports are also contemplated.

[0104] Figure 4A -D schematically illustrates the first manifold 44 according to some embodiments of the present invention, and in more detail, wherein: Figure 4A shows an isometric view, and 4B-D show Figure 4A Along line AA ( Figure 4B ), A'-A' line ( Figure 4C ) and A”-A” line ( Figure 4D ). The first manifold 44 preferably includes a fluid inlet 50 for receiving fluid from one of the panel connectors. For example, the disposable connector 14c can be mounted on the fluid inlet 50, in which case the inlet 50 is connected to the panel connector 172 (see Figure 1) receives fluid (e.g., air). In embodiments where the device 10 includes a saline inlet port 18 and / or a waste port 20, these ports may also be formed on the first manifold 44, with corresponding connectors 18a, 20a, optionally and preferably disposable connectors mounted thereon.

[0105] The manifold 44 preferably includes two or more separate fluid passages therein. Figure 4A In the schematic illustration shown in FIG. 4A , which is not to be considered limiting, the manifold 44 includes five interconnecting ports, two of which (shown at 72) are part of the first fluid passage 58 and three of which (shown at 74) are part of the second fluid passage 60. Preferably, any fluid communication between the first passage 58 and the second passage 60 within the manifold 44 is prevented. The separation between the passages 58 and 60 ensures that there is no mixing in the manifold 44 between fluids delivered through different external lines (e.g., to and from the endotracheal tube device 102).

[0106] The first fluid channel 58 communicates with both the inlet 50 and the inlet 18 (when in use), so that the interconnection port 72 serves as an outflow port for delivering fluid (e.g., air, saline) from the inlet 50 or 18 to the channel 58 and out of the manifold 44. Preferably, but not necessarily, a one-way valve 52 is mounted within the disposable fluid connector 14c. An advantage of these embodiments is that the one-way valve 52 prevents saline from entering the system 100 from the port 18 through the gas supply connector 172.

[0107] The interconnection port 74 of the second fluid channel 60 is preferably used to receive fluid (e.g., air, saline, secretions) into the manifold 44. In some embodiments of the present invention, the waste port 20 is located within or otherwise in fluid communication with the second fluid channel 60. Because the waste port 20 is connected to the waste collection container 138, the negative pressure in the container 138 also exists in the waste port 20, and thus, the flow into the channel 60 through the interconnection port 74 can be established by means of the negative pressure in the waste port 20.

[0108] Some of the interconnection ports of the second manifold 46 serve as inflow interconnection ports 78 through which fluid enters the manifold 46 from the channels 58 of the manifold 44, while other interconnection ports serve as outflow interconnection ports 76 through which fluid exits the manifold 46 into the channels 60 of the manifold 44. In embodiments where the interconnectors 48 are connected between the interconnection ports of the manifolds in a one-to-one relationship, the number of interconnection ports in the manifolds 44 and 46 is the same, with each outflow interconnection port of the manifold 44 connected to an inflow interconnection port of the manifold 46 via an interconnector, and each inflow interconnection port of the manifold 44 connected to an outflow interconnection port of the manifold 46 via an interconnector.

[0109] In some embodiments of the present invention, the second manifold 46 is configured to establish two or more separate flow paths, more preferably three or more different distribution ports. Preferably, but not necessarily, the second manifold 46 establishes a separate flow path for each distribution port.

[0110] The flow paths established within the manifold 46 preferably do not form a one-to-one mapping between distribution ports and interconnection ports. That is, there is at least one distribution port that is in fluid communication with more than one interconnection port. For example, a particular fluid distribution port (e.g., at least one of ports 16a and 16b) can be in fluid communication with one inflow interconnection port 78 and one outflow interconnection port 76 of the second manifold 46. An advantage of this embodiment is that it allows the same fluid distribution port to also deliver fluid from the endotracheal tube device 102. In various exemplary embodiments of the present invention, there is also at least one distribution port that is fluidically isolated from all interconnection ports within the manifold 46. For example, when port 16c is in direct fluid communication with the disposable fluid connector 14b connected to the cuff inflation connector 174, port 16c can be fluidically isolated from all interconnection ports 16a-d and the vacuum port 26 within the manifold 46.

[0111] Representative examples of separate flow paths within manifold 46 according to some embodiments of the present invention are shown in FIG. Figure 5 It is shown schematically in Figure 5 Separate fluid paths are illustrated by dashed lines in FIG. As shown, first fluid path 82 is a bifurcated path between a first pair 84 of fluid interconnects 76, 78 and first dispensing port 16a, second fluid path 86 is a bifurcated path between a second pair 88 of fluid interconnects 76, 78 and second dispensing port 16b, and third fluid path 80 is a non-bifurcated path establishing a one-to-one fluid connection between one fluid interconnect 76 and one dispensing port 16d. Preferably, first fluid path 84 and second fluid path 88 are dedicated to delivering fluid to or extracting fluid from fluid lines 106a, 106b of endotracheal tube device 102, but not to or extracting fluid from cuff inflation line 106c of endotracheal tube device 102, while third fluid path 80 is dedicated to extracting fluid from collapsible catheter 105.

[0112] Now refer to Figure 6A -C, Figure 6A-C is a schematic diagram of a valve system 180 according to various exemplary embodiments of the present invention. The valve system 180 is particularly useful for controlling flow in a fluid interconnector 48 of the device 10, but can also be used with any system that needs to control flow through a piping system having a fluid interconnector without requiring an opening in the piping system or a joint in the piping system, and without requiring direct contact with the fluid contained in the piping. The valve system 180 is capable of controlling flow in a tube having flexible walls. Therefore, when the valve system 180 is used to control flow in a fluid interconnector, the fluid interconnector is a flexible-walled tube. Specifically, when the valve system 180 is used to control flow in the fluid interconnectors 48 of the device 10, the wall of each fluid interconnector 48 is made flexible and compressible.

[0113] The valve system 180 generally includes a main structure 182 to which the various components of the valve system 180 can be mounted. When the valve system 180 is used with the system 100 to control flow in the fluid interconnect 48 of the device 10, the main structure 182 of the system 180 can be mounted on the system 100 opposite the window 30 of the housing 12 (see FIG. Figure 1 ). The valve system 180 preferably includes a plurality of movable pressing members 184, which are typically, but not necessarily, formed as pressing fingers. Each pressing member 184 is aligned to engage a wall of the interconnector 48 (not shown, see Figure 3 ), such that movement of the pressing member toward the corresponding wall of the interconnector generates a compressive force on the corresponding wall and restricts or stops the flow through the corresponding interconnector.

[0114] The movement of the pressing member 184 is preferably reciprocating linear motion. This can be achieved by providing the valve system 180 with a camshaft 186 having a plurality of cams 188, which can be rotated, for example, by means of a motor 190 and, optionally and preferably, a transmission gear 192. The motor 190 is preferably controlled by the controller 120 of the system 100 to perform various operations in response to signals received from the processing system 116. Each of the cams 188 is aligned with one of the pressing members 184, so that rotation of the cam 188 creates reciprocating linear motion of the pressing member 184. Alternatively, the movement of the pressing member 184 can be controlled by applying other types of forces. For example, one or more of the components 184 can be pneumatically, electrically, or electromagnetically driven pistons. Although the following embodiments are described with particular emphasis on the pressing member 184 being controlled by a camshaft, it should be understood that other types of mechanisms for controlling the pressing member 184, such as, but not limited to, the pneumatic, electric, or electromagnetic mechanisms described above, are also contemplated according to some embodiments of the present invention.

[0115] When used with the system 100 and the device 10, the controller 120 signals the motor 190 to rotate the shaft 186 so that the press member 184 selectively and individually restricts (e.g., blocks) or allows flow in the interconnect 48, thereby closing and opening the fluid path between the dispense port 16 and the connector on the faceplate 108, and optionally and preferably also closing and opening the fluid path between the dispense port 16 and the saline inlet port 18, and / or the waste port 20, according to a program executed by the controller 120.

[0116] Now refer to Figure 7A -M, Figure 7A -M describes several examples of such fluid paths according to some embodiments of the present invention. Figure 7A In the examples, an "X" symbol in a fluid interconnector 48 indicates a state in which the valve system 180 blocks flow in the fluid interconnector (e.g., by pressing the corresponding member 184 against the wall of the fluid interconnector); a dashed line between the connector 20a and the waste collection container 138, or between the connector 20a and the vacuum port connector 26a, indicates a state in which no flow is flowing into or out of the container 138; a solid line indicates an open fluid path, and arrows indicate the direction of flow along the corresponding fluid path. These examples relate to a configuration having five fluid interconnectors 48, indicated by reference numerals 48a, 48b, 48c, 48d, and 48e.

[0117] Figure 7A A standby state is shown in which all fluid paths are closed and there is no flow into or out of the container 138 .

[0118] Figure 7B The state in which interconnects 48a and 48d are open and all other interconnects are closed is shown. Fluid enters manifold 46 through port 16a, continues through interconnect 48a, enters manifold 44 through inflow interconnect port 74, and is redirected into container 138 through waste port 20 by negative pressure delivered by vacuum port 26. Gas (e.g., air) delivered by system 100 via gas supply connector 172 enters manifold 44 through port 50, exits manifold 44 through one of outflow ports 72, continues into interconnect 48d, enters manifold 46 through one of inflow ports 78, and exits manifold 46 through port 16b. This state is particularly useful for forcing air through line 106b of endotracheal tube device 102 while simultaneously draining tracheal secretions through line 106a.

[0119] Figure 7CThe state in which interconnects 48b and 48e are open and all other interconnects are closed is shown. Fluid enters manifold 46 through port 16b, continues through interconnect 48e, enters manifold 44 through inflow interconnect port 74, and is redirected into container 138 through waste port 20 by negative pressure delivered by vacuum port 26. Gas (e.g., air) delivered by system 100 via gas supply connector 172 enters manifold 44 through port 50, exits manifold 44 through one of outflow ports 72, continues into interconnect 48b, enters manifold 46 through one of inflow ports 78, and exits manifold 46 through port 16a. This state is particularly useful for forcing air through line 106a of endotracheal tube device 102 while simultaneously draining tracheal secretions through line 106b.

[0120] Figure 7D The state in which interconnects 48a and 48d are open and all other interconnects are closed is shown. Fluid enters manifold 46 through port 16a, continues in interconnect 48a through one of the inflow interconnect ports 74 into manifold 44, and is redirected into container 138 through waste port 20 by the negative pressure delivered by vacuum port 26. Saline delivered by saline source 29 enters manifold 44 through port 18, exits manifold 44 through one of the outflow ports 72, continues into interconnect 48d, enters manifold 46 through one of the inflow ports 78, and exits manifold 46 through port 16b. This state is particularly useful for flushing saline through line 106b of endotracheal tube device 102 while simultaneously draining tracheal secretions through line 106a.

[0121] Figure 7E The state in which interconnects 48b and 48e are open and all other interconnects are closed is shown. Fluid enters manifold 46 through port 16b, continues in interconnect 48e through one of the inflow interconnect ports 74 into manifold 44, and is redirected into container 138 through waste port 20 by the negative pressure delivered by vacuum port 26. Saline delivered by saline source 29 enters manifold 44 through port 18, exits manifold 44 through one of the outflow ports 72, continues into interconnect 48b, enters manifold 46 through one of the inflow ports 78, and exits manifold 46 through port 16a. This state is particularly useful for flushing saline through line 106a of endotracheal tube device 102 while simultaneously draining tracheal secretions through line 106b.

[0122] Figure 7FThe interconnect 48b is shown open, the interconnects 48a, 48c and 48d are closed, and the port 26 is not delivering a vacuum so that there is no flow into or out of the container 138. The interconnect 48e may also be closed, but since there is no flow to the container 138, the interconnect 48e may also remain open, as shown. Figure 7F As shown, saline delivered by saline source 29 enters manifold 44 through port 18, exits manifold 44 through one of outflow ports 72, continues into interconnector 48b, enters manifold 46 through one of inflow ports 78, and exits manifold 46 through port 16a. This state is particularly useful for flushing saline through tubing 106a of endotracheal tube device 102.

[0123] Figure 7G The interconnect 48d is shown open, the interconnects 48b, 48c and 48e are closed, and the port 26 is not delivering a vacuum so that there is no flow into or out of the container 138. The interconnect 48a may also be closed, but since there is no flow to the container 138, the interconnect 48a may also remain open, as shown. Figure 7G As shown, saline delivered by saline source 29 enters manifold 44 through port 18, exits manifold 44 through one of outflow ports 72, continues into interconnector 48d, enters manifold 46 through one of inflow ports 78, and exits manifold 46 through port 16b. This state is particularly useful for flushing with saline via tubing 106b through endotracheal tube device 102.

[0124] Figure 7H The interconnector 48a is shown to be open, the interconnectors 48b, 48c and 48e are closed, and no gas or saline is delivered to the manifold 44. The interconnector 48d may also be closed, but the interconnector 48d may also remain open because gas or saline is delivered, as shown in FIG. Figure 7H Fluid enters manifold 46 through port 16a, continues through one of inflow interconnect ports 74 in interconnector 48a, enters manifold 44, and is redirected by negative pressure delivered through vacuum port 26 through waste port 20 into container 138. This state is particularly useful for performing leak detection procedures via line 106a of endotracheal tube device 102.

[0125] Figure 7I The interconnector 48e is shown to be open, the interconnectors 48a, 48c and 48d are closed, and no gas or saline is delivered to the manifold 44. The interconnector 48b may also be closed, but the interconnector 48b may also remain open because gas or saline is being delivered, as shown in FIG. Figure 7IFluid enters manifold 46 through port 16b, continues through one of inflow interconnect ports 74 in interconnector 48e, enters manifold 44, and is redirected by negative pressure delivered by vacuum port 26 through waste port 20 into container 138. This state is particularly useful for performing leak detection procedures via line 106b of endotracheal tube device 102.

[0126] Figure 7J and 7K The interconnector 48c is shown in a state where it is open, and the interconnectors 48a, 48d and 48e ( Figure 7J ) or 48a, 48b and 48e( Figure 7K ) is closed and no gas or saline is delivered to the manifold 44. Figure 7J The interconnector 48b may also be closed, but the interconnector 48b may also remain open because gas or saline is being delivered. Figure 7K Interconnect 48d can also be closed, but can also remain open as gas or saline is delivered. Fluid enters manifold 46 through port 16d, continues through interconnect 48e through one of the inflow interconnect ports 74 into manifold 44, and is redirected into container 138 through waste port 20 by the negative pressure delivered by vacuum port 26. This state is useful for more than one operation.

[0127] In some embodiments of the present invention, the status is used to perform a leak detection procedure through the circuit 106a of the endotracheal tube device 102.

[0128] In some embodiments of the present invention, said state is used to perform evacuation of secretions using a separate suction catheter 105 , the proximal end of which is connected to the connector 86 d and the distal end of which is introduced into the main lumen of the device 102 .

[0129] In some embodiments of the present invention, the state is used to remove contaminated gas from the container 138, for example, gas from the trachea of ​​a subject and accumulated in the container 138 while the system 100 applies suction to one or more lines 106a of the endotracheal tube device 102. By allowing clean gas to enter the manifold 46 through port 16d, the contaminated gas can be removed from the container 138. Thus, this embodiment establishes fluid communication between the connector 86d and a source of ambient air or clean gas (not shown), rather than between the connector 86d and the main chamber of the device 102. Through the negative pressure delivered by the vacuum port 26, the clean gas or ambient air flows through the connector 86d, into the manifold 46, and on to the manifold 44, where it is redirected into the container 138 and replaces at least a portion of the contaminated gas therein.

[0130] Figure 7L A state is shown in which all interconnects are closed and no gas or saline is being delivered to the manifold 44. This state is particularly useful for checking for leaks in the container 138.

[0131] Figure 7M The state in which interconnects 48a and 48b are open and all other interconnects are closed is shown. Gas (e.g., air) delivered by system 100 via gas supply connector 172 enters manifold 44 through port 50, exits manifold 44 through one of outflow ports 72, continues into interconnect 48b, enters manifold 46 through one of inflow ports 78, is redirected back to manifold 44 through one of outflow ports 76 and interconnect 48a, and enters manifold 44 through one of inflow interconnect ports 74. Furthermore, negative pressure delivered through vacuum port 26 is redirected through waste port 20 into container 138. This state is particularly useful for forcing air into container 138 to vent the container.

[0132] As used herein, the term "about" refers to ±10%.

[0133] The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any embodiment described as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments and / or to exclude the incorporation of features from other embodiments.

[0134] The word “optionally” is used herein to mean “provided in some embodiments and not provided in other embodiments.” Any particular embodiment of the invention may include multiple “optional” features, unless such features are in conflict.

[0135] The terms "including," "comprising," "containing," "comprising," "having" and their equivalents mean "including but not limited to."

[0136] The term "consisting of" means "including and limited to."

[0137] The term "consisting essentially of" means that a composition, method, or structure may include additional ingredients, steps, and / or parts, but only when the additional ingredients, steps, and / or parts do not materially alter the basic and novel characteristics of the claimed composition, method, or structure.

[0138] As used herein, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. For example, the term "a compound" or "at least one compound" may include a plurality of compounds, including mixtures thereof.

[0139] Throughout this application, various embodiments of the present invention may be presented in range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Therefore, the description of a range should be considered to have specifically disclosed all possible subranges and individual numerical values ​​within the range. For example, a description of a range such as 1 to 6 should be considered to have specifically disclosed subranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., as well as individual numbers within the range, such as 1, 2, 3, 4, 5, and 6. This applies regardless of the width of the range.

[0140] Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integer) within the indicated range. The phrases "a range" between a first indicated numeral and a second indicated numeral and "a range from a first indicated numeral to a second indicated numeral" are used interchangeably herein and are meant to include the first indicated numeral and the second indicated numeral and all fractions and integers therebetween.

[0141] It should be understood that certain features of the present invention described in the context of separate embodiments for the sake of clarity may also be provided in combination in a single embodiment. Conversely, various features of the present invention described in the context of a single embodiment for the sake of brevity may also be provided separately or in any suitable subcombination, or as suitable features in any other described embodiment of the present invention. Certain features described in the context of various embodiments should not be considered essential features of those embodiments unless the embodiment is inoperative without those elements.

[0142] Although the present invention has been described in conjunction with specific embodiments thereof, it is apparent that many substitutions, modifications and variations will be apparent to those skilled in the art. Therefore, the present invention is intended to include all such substitutions, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0143] All publications, patents and patent applications mentioned in this specification are incorporated herein by reference in their entirety, and their extent is as if each independent publication, patent or patent application specifically and individually points out that they are incorporated herein by reference. In addition, the quoting or identification of any reference in this application should not be construed as admitting that such reference can be used as the obtainable prior art of the present invention. In the case of using part titles, they should not be construed as necessary restrictions. In addition, any priority document of the application is incorporated herein by reference in its entirety.

Claims

1. A fluid distribution device for mechanical ventilation, comprising: Disposable housing; a disposable fluid connector connectable to a compatible panel connector of a control system that controls flow in the endotracheal tube device; as well as a first manifold and a second manifold, each mounted within the disposable housing and connected to one another via a plurality of fluid interconnects, each of the fluid interconnects being controllable by a valve system; wherein the first manifold comprises a fluid inlet for receiving fluid from one of the panel connectors, and wherein the second manifold comprises a plurality of fluid distribution ports adapted to establish fluid communication between the fluid interconnector and the fluid lines of the endotracheal tube device.

2. The device according to claim 1, wherein The second manifold is configured to establish separate flow paths to at least two different dispensing ports.

3. The device according to claim 2, wherein The separate flow paths include a first fluid path between a first pair of fluid interconnectors and a first dispensing port, and a second fluid path between a second pair of fluid interconnectors and a second dispensing port.

4. The device according to claim 1, wherein The second manifold is configured to establish separate flow paths to at least three different distribution ports.

5. The device according to claim 4, wherein The separate flow paths include a first fluid path between a first pair of fluid interconnectors and a first dispensing port, a second fluid path between a second pair of fluid interconnectors and a second dispensing port, and a third fluid path between an additional fluid interconnector and a third dispensing port.

6. The device according to claim 1, wherein The disposable fluid connector comprises a disposable cuff inflation connector connectable to a compatible control panel cuff inflation connector, and wherein the second manifold comprises a cuff inflation port for establishing fluid communication between the disposable cuff inflation connector and a cuff inflation line of the endotracheal tube device.

7. The device according to any one of claims 2 to 5, wherein: The disposable fluid connector comprises a disposable cuff inflation connector connectable to a compatible control panel cuff inflation connector, and wherein the second manifold comprises a cuff inflation port for establishing fluid communication between the disposable cuff inflation connector and a cuff inflation line of the endotracheal tube device.

8. The device according to claim 1, wherein The disposable fluid connector includes a disposable vacuum connector connectable to a compatible control panel vacuum connector, and wherein the second manifold includes a vacuum port for establishing fluid communication between the disposable vacuum connector and a vacuum line that creates negative pressure in a waste collection container that receives waste fluid from the subject.

9. The device according to any one of claims 2 to 6, wherein: The disposable fluid connector includes a disposable vacuum connector connectable to a compatible control panel vacuum connector, and wherein the second manifold includes a vacuum port for establishing fluid communication between the disposable vacuum connector and a vacuum line that creates negative pressure in a waste collection container that receives waste fluid from the subject.

10. The device according to claim 8, wherein The first manifold includes a waste port connectable to a waste line that delivers the waste fluid to the waste collection container.

11. The device according to claim 9, wherein The first manifold includes a waste port connectable to a waste line that delivers the waste fluid to the waste collection container.

12. The device according to claim 10, wherein The first manifold includes a first fluid channel and a second fluid channel therein that are separated from each other, and wherein the waste port of the first manifold is configured to be fed by fluid from the second fluid channel and is fluidly separated from the first fluid channel within the first manifold.

13. The device according to claim 11, wherein The first manifold includes a first fluid channel and a second fluid channel therein that are separated from each other, and wherein the waste port of the first manifold is configured to be fed by fluid from the second fluid channel and is fluidly separated from the first fluid channel within the first manifold.

14. The device according to claim 1, wherein The first manifold includes at least two separate fluid channels therein.

15. The device according to any one of claims 2 to 6, wherein: The first manifold includes at least two separate fluid channels therein.

16. The device according to claim 14, wherein The disposable fluid connector comprises a disposable fluid inlet connector connectable to a compatible gas supply panel connector of the control system, wherein a first fluid channel is in fluid communication with the disposable fluid inlet connector, and wherein a second fluid channel is fluidly isolated from the disposable fluid inlet connector within the first manifold.

17. The device according to claim 15, wherein The disposable fluid connector comprises a disposable fluid inlet connector connectable to a compatible gas supply panel connector of the control system, wherein a first fluid channel is in fluid communication with the disposable fluid inlet connector, and wherein a second fluid channel is fluidly isolated from the disposable fluid inlet connector within the first manifold.

18. The device of claim 16, comprising a saline inlet port connectable to a saline supply line, wherein the first fluid channel is configured to be fed by saline from the saline inlet port, and wherein the second fluid channel is fluidly isolated from the saline inlet port within the first manifold.

19. The device of claim 17 , comprising a saline inlet port connectable to a saline supply line, wherein the first fluid channel is configured to be fed by saline from the saline inlet port, and wherein the second fluid channel is fluidly isolated from the saline inlet port within the first manifold.

20. The device of claim 14, comprising a saline inlet port connectable to a saline supply line, wherein the first fluid channel is configured to be fed by saline from the saline inlet port, and wherein the second fluid channel is fluidly isolated from the saline inlet port within the first manifold.

21. The device of claim 15, comprising a saline inlet port connectable to a saline supply line, wherein the first fluid channel is configured to be fed by saline from the saline inlet port, and wherein the second fluid channel is fluidly isolated from the saline inlet port within the first manifold.

22. The device according to claim 1, wherein The valve system is external to the fluid interconnector.

23. The device according to any one of claims 2-6, 8, 10, 12, 14, 16, 18, and 20, wherein: The valve system is external to the fluid interconnector.

24. The apparatus according to claim 22, wherein The valve system is external to the disposable housing.

25. The apparatus according to claim 23, wherein The valve system is external to the disposable housing.

26. The apparatus according to claim 24, wherein The disposable housing includes a window that exposes the fluid interconnect to allow the valve system to engage the fluid interconnect.

27. The apparatus according to claim 25, wherein The disposable housing includes a window that exposes the fluid interconnect to allow the valve system to engage the fluid interconnect.

28. The apparatus according to claim 1, wherein The valve system includes a plurality of movable press members, each press member aligned to engage a wall of one of the fluid interconnectors such that movement of the press member toward the corresponding wall generates a compressive force on the corresponding wall and restricts or stops flow through the corresponding fluid interconnector.

29. The device according to any one of claims 2-6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26, wherein The valve system includes a plurality of movable press members, each press member aligned to engage a wall of one of the fluid interconnectors such that movement of the press member toward the corresponding wall generates a compressive force on the corresponding wall and restricts or stops flow through the corresponding fluid interconnector.

30. The apparatus according to claim 28, wherein The valve system includes a camshaft having a plurality of cams, each cam being aligned with one of the press members such that rotation of a cam creates linear motion of the corresponding press member.

31. The apparatus according to claim 29, wherein The valve system includes a camshaft having a plurality of cams, each cam being aligned with one of the press members such that rotation of a cam creates linear motion of the corresponding press member.

32. A system for controlling and monitoring flow in a cuffed endotracheal tube device, comprising: a connector panel adapted to be connected to a disposable housing of a fluid dispensing device and having a plurality of panel connectors adapted to be connected to disposable fluid connectors of the fluid dispensing device; a valve system configured to selectively control flow within the fluid dispensing device; as well as a controller configured to send a control signal to the valve system; wherein the fluid distribution device comprises a first manifold and a second manifold, both of which are mounted within the disposable housing and connected to each other via a plurality of fluid interconnectors, each of which is controllable by the valve system, wherein the first manifold comprises a fluid inlet for receiving fluid from one of the panel connectors, and wherein the second manifold comprises a plurality of fluid distribution ports adapted to establish fluid communication between the fluid interconnectors and the fluid lines of the endotracheal tube device.

33. The system of claim 32, wherein: The valve system is external to the disposable housing.

34. The system of claim 33, wherein: The disposable housing includes a window that exposes the fluid interconnect to allow the valve system to engage the fluid interconnect.

35. The system of claim 32, wherein: The first manifold includes a waste port connectable to a waste line that delivers waste fluid to a waste collection container.

36. The system according to any one of claims 33-34, wherein: The first manifold includes a waste port connectable to a waste line that delivers waste fluid to a waste collection container.

37. The system of claim 35, wherein: The disposable fluid connector includes a disposable vacuum connector connectable to a compatible control panel vacuum connector of the system, and wherein the second manifold includes a vacuum port for establishing fluid communication between the disposable vacuum connector and a vacuum line that creates negative pressure in the waste collection container.

38. The system of claim 36, wherein: The disposable fluid connector includes a disposable vacuum connector connectable to a compatible control panel vacuum connector of the system, and wherein the second manifold includes a vacuum port for establishing fluid communication between the disposable vacuum connector and a vacuum line that creates negative pressure in the waste collection container.

39. The system of claim 35, wherein: The control signal includes a signal that causes the valve system to open a fluid path from a fluid dispensing port to the waste port.

40. The system of claim 36, wherein: The control signal includes a signal that causes the valve system to open a fluid path from a fluid dispensing port to the waste port.

41. The system of claim 39, wherein: The signal also causes the valve system to simultaneously open another fluid path from the panel connector of the system to another fluid dispensing port.

42. The system of claim 40, wherein: The signal also causes the valve system to simultaneously open another fluid path from the panel connector of the system to another fluid dispensing port.

43. The system of claim 37, wherein: The control signals include signals that cause the valve system to open a fluid path from a panel connector of the system to one of the interconnectors and to open a fluid path from the interconnector to the waste port through another interconnector.

44. The system of claim 38, wherein: The control signals include signals that cause the valve system to open a fluid path from a panel connector of the system to one of the interconnectors and to open a fluid path from the interconnector to the waste port through another interconnector.

45. A fluid dispensing device comprising a disposable fluid connector connectable to a compatible panel connector of a control system, a first manifold, and a second manifold, wherein the first manifold and the second manifold are connected to each other by a plurality of fluid interconnectors, each fluid interconnector being controllable by a valve system; the first manifold including at least two separate fluid channels therein; The first manifold includes at least one fluid inlet for receiving fluid from at least one panel connector; The second manifold includes a plurality of fluid distribution ports adapted to establish fluid communication between the fluid interconnector and external fluid lines.

46. ​​The apparatus of claim 45, wherein The second manifold is configured to establish separate flow paths to at least two different dispensing ports.

47. The apparatus of claim 46, wherein: The separate flow paths include a first fluid path between a first pair of fluid interconnectors and a first dispensing port, and a second fluid path between a second pair of fluid interconnectors and a second dispensing port.

48. The apparatus of claim 45, wherein The second manifold is configured to establish separate flow paths to at least three different distribution ports.

49. The apparatus according to claim 48, wherein The separate flow paths include a first fluid path between a first pair of fluid interconnectors and a first dispensing port, a second fluid path between a second pair of fluid interconnectors and a second dispensing port, and a third fluid path between an additional fluid interconnector and a third dispensing port.

50. The device according to any one of claims 45 to 49, wherein The disposable fluid connector includes a disposable vacuum connector connectable to a compatible control panel vacuum connector, and wherein the second manifold includes a vacuum port for establishing fluid communication between the disposable vacuum connector and a vacuum line that creates negative pressure in a waste collection container that receives waste fluid from the subject.

51. The apparatus of claim 50, wherein: The first manifold includes a waste port connectable to a waste line that delivers the waste fluid to the waste collection container.

52. The apparatus of claim 51, wherein The first manifold includes a first fluid channel and a second fluid channel therein that are separated from each other, and wherein the waste port of the first manifold is configured to be fed by fluid from the second fluid channel and is fluidly separated from the first fluid channel within the first manifold.

53. The device according to any one of claims 45 to 49, wherein The disposable fluid connector comprises a disposable fluid inlet connector connectable to a compatible gas supply panel connector of the control system, wherein a first fluid channel is in fluid communication with the disposable fluid inlet connector, and wherein a second fluid channel is fluidly isolated from the disposable fluid inlet connector within the first manifold.

54. The device of claim 53, comprising a saline inlet port connectable to a saline supply line, wherein the first fluid channel is configured to be fed by saline from the saline inlet port, and wherein the second fluid channel is fluidly isolated from the saline inlet port within the first manifold.

55. The device according to any one of claims 45 to 49, wherein The valve system is external to the fluid interconnector.

56. The device of claim 55, further comprising a disposable housing, the disposable housing comprising a window exposing the fluid interconnect to allow the valve system to engage the fluid interconnect.

57. The device according to any one of claims 45 to 49, wherein The valve system includes a plurality of movable press members, each press member aligned to engage a wall of one of the fluid interconnectors such that movement of the press member toward the corresponding wall generates a compressive force on the corresponding wall and restricts or stops flow through the corresponding fluid interconnector.

58. The apparatus of claim 57, wherein The valve system includes a camshaft having a plurality of cams, each cam being aligned with one of the press members such that rotation of a cam creates linear motion of the corresponding press member.

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