WO2017139691A1

WO2017139691A1 - Closed suctioning endotracheal devices, systems and methods

Info

Publication number: WO2017139691A1
Application number: PCT/US2017/017545
Authority: WO
Inventors: Dani Hackner; Michael J. Baker; Gene WEY
Original assignee: Cedars-Sinai Medical Center
Priority date: 2016-02-12
Filing date: 2017-02-10
Publication date: 2017-08-17
Also published as: EP3413961A1; EP3413961A4

Abstract

In various embodiments, the present application discloses a closed suction system (CSS) for rinsing and suctioning a subject's airway and/or an endotracheal tube positioned therein. In certain embodiments, the rinsing and/or suctioning are controlled electronically, and each rinsing and/or suctioning event is automatically communicated to a patient's electronic health record. Various aspects of the apparatuses, systems and methods disclosed herein contribute to reducing the likelihood of infection and improving the likelihood that a patient is suctioned in the correct manner and frequency.

Description

CLOSED SUCTIONING ENDOTRACHEAL DEVICES, SYSTEMS AND METHODS

FIELD OF THE INVENTION

The present invention generally relates to apparatuses, systems and methods for medical procedures, and especially those that require injecting a substance into a subject's body. More particularly, the present disclosure relates to apparatuses, systems, and methods for endotracheal suctioning that automatically block suctioning or administering fluids to a patient to easily track fluid administration and suctioning while preventing infection.

BACKGROUND

All publications herein are incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. The following description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.

Endotracheal intubation involves the insertion of a flexible plastic tubular device, known as an endotracheal tube, into the trachea of a patient to protect the patient's airway and provide means of mechanical ventilation. The most common method teaches the passing of an endotracheal tube, with the assistance of a laryngoscope, through the mouth, larynx, and vocal cords into the trachea, terminating at a position above the carina.

The primary purposes of endotracheal intubation are to mechanically ventilate the patient's lungs when a disease or other condition prevents the patient from normal breathing induced ventilation, or to apply anesthetic gases during surgical intervention. In order to create enough air pressure to accomplish such mechanical ventilation and to prevent the escape of gases past the tube, it is necessary to seal the passageway around the endotracheal tube. When the endotracheal tube has been introduced into the patient's trachea, an inflatable cuff will normally be located a few centimeters above the carina and within the tube-like trachea. The inflatable cuff is then inflated so as to engage the wall of the trachea and to help secure it in place and protect the airway from blood, vomit, and secretions. Gases may then be introduced through the endotracheal tube and into the lungs of the patient.

Although endotracheal tubes have been effectively used in treating patients requiring respiratory ventilation, several complications may arise. In particular, many patients receiving endotracheal intubation develop complications resulting from an infection of the lungs, possibly induced by contaminated pooled secretions entering the trachea and lungs. Infectious secretions may also reach the lungs upon cessation of mechanical ventilation, particularly when the need for endotracheal intubation ends and the inflatable cuff of the endotracheal tube is deflated. This allows the infectious secretions which have pooled above the inflatable cuff to flow into the lungs. In certain instances, infectious secretions may reach the lungs during intubation, generally by aspiration of the secretions past the tracheal tube cuff.

Endotracheal suctioning is a common and effective procedure in patients receiving endotracheal intubation. In performing endotracheal suctioning, secretions accumulated in the tracheobronchial tree of the patient are cleared, leading to reduced incidence and frequency of infection and other complications due to accumulation of secretions. In addition, endotracheal suctioning promotes optimal oxygenation of the lungs. However, endotracheal suctioning has been known to have adverse effects; primarily, microbial contamination of the airway and lungs, and development of ventilator-associated pneumonia.

Suctioning is accomplished by using an open suctioning system ("OSS") or a closed suctioning system ("CSS"). OSSs have been used since the late 1970s, and involve a single- use device. An OSS requires the sealed ventilator circuit to be broken for enactment of endotracheal suctioning, thereby allowing for possible contamination and infection of both the caregiver and the patient. Closed suctioning systems ("CSSs") were introduced to limit the problems of contamination and infection associated with OSSs, and to allow the ventilator circuit to stay intact while performing endotracheal suctioning. In addition, a CSS may be complemented with the integration of a suction tube within the tracheal tube. The suction tube may be used to remove pooled secretions from the pulmonary area via endotracheal suctioning without disconnecting the patient from the ventilation system, which significantly reduces the incidence of infection. Based on advantages such as lower incidence of ventilator associated pneumonia, fewer physiological disturbances, decreased microbiological contamination, and low cost, CSSs have become increasingly popular, and account for the vast majority of endotracheal suctioning used in the United States. (Paul -Allen et al., Survey of Nursing Practices with Closed-System Suctioning, American Journal of Critical Care ((January 2000), 9(1):9-17)

It is worth noting that the progression of endotracheal suctioning methods from using OSSs to CSSs, and further safeguards produced in an attempt to reduce the rate of infection, have not entirely eliminated the incidents of infection and contamination, and therefore numerous patients continue to suffer from shortcomings of the most commonly used technologies.

For example, CSSs commonly employ a cavity found within the CSS system that allows a caregiver to inject liquid (such as saline) into the circuit or airway, before, during or after the suction procedure. As the injection requires a break in the system, the CSS is compromised, allowing for contamination. As a contaminated syringe, a contaminated liquid, or contaminated equipment associated with either the syringe or liquid, may be the culprit for infection, the incidence and possibility of disseminating a pathogen remains a primary health concern.

The incidence of infections and complications associated with infections are also exacerbated by the inaccurate administration of one or more liquid solutions, a common practice performed prior to endotracheal suctioning. An additional shortcoming of existing suctioning methods is that administration of lavage fluid is not electronically tracked by commercially available technologies. Instead, electronic health records typically require respiratory therapists or nurses to estimate the time of lavage/suctioning. Unfortunately, the frequency of suctioning is often not adequate in many healthcare environments, especially long-term care or at home care facilities. Finally, disturbances in the airway circuit lead to de-recruitment (decreasing functioning lung units), but this cannot be identified by previously available technologies.

An unfulfilled need exists for an improved apparatuses, systems, and methods for endotracheal suctioning that automatically block suctioning or administering fluids to a patient automatically to easily track fluid administration and suctioning while preventing infection.

BRIEF SUMMARY OF THE DISCLOSURE

An aspect of the present disclosure provides a system for endotracheal suctioning, the system including: (1) a fluid delivery apparatus that includes (a) a fluid delivery chamber configured to contain a fluid; (b) a fluid channel in fluid communication with said fluid delivery chamber; (c) a fluid inlet configured to direct the fluid into said fluid delivery chamber; (d) a fluid outlet in fluid communication with said fluid channel; (e) a plunger configured to engage in said fluid delivery chamber and advance the fluid contained therein through said fluid channel and out of said fluid outlet; and (f) a trifurcated fluid delivery connector (FDC) comprising first, second and third connected FDC lumens, wherein (i) said first FDC lumen is configured to connect to said fluid outlet, (ii) said second FDC lumen is configured to connect to an endotracheal tube (ETT), and (iii) said third FDC lumen is configured to connect to a ballard connector which is configured to facilitate suctioning by a ballard catheter; and (2) a trifurcated ballard connector (BC) comprising first, second and third connected BC lumens; wherein (i) said first BC lumen is operably connected to the third FDC lumen, (ii) said second BC lumen is configured to connect to a ventilator, and (iii) said third BC lumen is configured to accommodate a ballard catheter.

The fluid delivery chamber and plunger may be configured to be housed within a compressible outer shell comprising at least two opposing and nesting spring loaded components, which are configured such that compression of the outer shell causes the plunger to advance within the fluid delivery chamber and thereby advance fluid contained therein through said fluid channel and out of said fluid outlet.

The fluid inlet includes a one way inlet valve that is configured to deliver fluid into said fluid delivery chamber.

The fluid outlet comprises a one way outlet valve may be configured to receive fluid from said fluid channel.

In an embodiment of the present disclosure, the system may include an ETT operatively connected to said second FDC lumen.

The system may include a ballard catheter, said ballard catheter including a first end and a second end; wherein the first end of said ballard catheter may be configured to be introduced through (a) said BC, (b) said FDC, and (c) said ETT, such that the first end of said ballard catheter can be utilized to suction secretions located in a subject's airway and/or in the ETT, when the second end of the ballard catheter is connected to a vacuum source.

In another embodiment of the present disclosure, the system may include a fluid reservoir; and a connecting tube; wherein said connecting tube connects said fluid reservoir to said fluid inlet.

The system may include a fluid flow controller (FFC) that is configured to regulate the flow of fluid to the ETT.

The FFC may be configured to electronically record data indicating one or more of (a) the time and/or date fluid was introduced into the ETT, (b) the amount of fluid introduced into the ETT, or (c) the rate at which fluid was introduced into the ETT.

The FFC may be configured to electronically communicate recorded data to a computing device. The electronic communication may be wireless.

In an aspect of the present disclosure, a method for endotracheal suctioning is disclosed. The method includes (1) providing a system for endotracheal suctioning, including: (a) a fluid delivery apparatus, including: (i) a fluid delivery chamber configured to contain a fluid; (ii) a fluid channel in fluid communication with said fluid delivery chamber; (iii) a fluid inlet configured to direct the fluid into said fluid delivery chamber; (iv) a fluid outlet in fluid communication with said fluid channel; (v) a plunger configured to engage in said fluid delivery chamber and advance the fluid contained therein through said fluid channel and out of said fluid outlet; and (vi) a trifurcated fluid delivery connector (FDC) comprising first, second and third connected FDC lumens; wherein (i) said first FDC lumen is configured to connect to said fluid outlet, (ii) said second FDC lumen is configured to connect to an endotracheal tube (ETT), and (iii) said third FDC lumen is configured to connect to a ballard connector which is configured to facilitate suctioning by a ballard catheter; and (b) a trifurcated ballard connector (BC) comprising first, second and third connected BC lumens; wherein (i) said first BC lumen is operably connected to the third FDC lumen, (ii) said second BC lumen is configured to connect to a ventilator, and (iii) said third BC lumen is configured to accommodate the ballard catheter; (2) connecting said second FDC lumen to an ETT engaged in a subject's airway; (3) connecting said second BC lumen to a ventilator; (4) connecting a second end of a ballard catheter to a vacuum; (5) connecting the fluid inlet of the fluid delivery apparatus to a fluid reservoir containing a rinsing fluid; (6) introducing a quantity of the rinsing fluid from said fluid reservoir into said fluid delivery apparatus; (7) introducing said rinsing fluid from said fluid delivery apparatus into said endotracheal tube and/or said subject's airway; (8) suctioning secretions and/or rinsing fluid from said endotracheal tube and/or said subject's airway by utilizing the vacuum via the ballard catheter.

In yet another aspect of the present disclosure, a system for endotracheal suctioning is disclosed. The system includes (1) a fluid delivery apparatus, including: (a) a fluid delivery chamber configured to contain a fluid; (b) a fluid channel in fluid communication with said fluid delivery chamber; (c) a fluid inlet configured to direct the fluid into said fluid delivery chamber; (d) a fluid outlet in fluid communication with said fluid channel; and (e) a trifurcated fluid delivery connector (FDC) comprising first, second and third connected FDC lumens; wherein (i) said first FDC lumen is configured to connect to said fluid outlet, (ii) said second FDC lumen is configured to connect to an endotracheal tube (ETT), and (iii) said third FDC lumen is configured to connect to a ballard connector which is configured to facilitate suctioning by a ballard catheter; and wherein said fluid delivery chamber comprises a collapsible pleated bellows structure; and (2) a trifurcated ballard connector (BC) comprising first, second and third connected BC lumens; wherein (i) said first BC lumen is operably connected to the third FDC lumen, (ii) said second BC lumen is configured to connect to a ventilator, and (iii) said third BC lumen is configured to accommodate a ballard catheter.

The fluid delivery chamber may be housed within an outer shell comprising at least two opposing and nesting components, which when compressed cause said collapsible pleated bellows structure to collapse and thereby advance fluid contained therein through said fluid channel and out of said fluid outlet.

The fluid inlet may include a one way inlet valve that is configured to deliver fluid into said fluid delivery chamber.

The fluid outlet may include a one way outlet valve that is configured to receive fluid from said fluid channel.

The system may further include an ETT operatively connected to said second FDC lumen.

The system may also include (1) a fluid reservoir; and (2) a connecting tube; wherein said connecting tube connects said fluid reservoir to said fluid inlet.

The FFC may be configured to electronically communicate the recorded data to a computing device. The electronic communication may be wireless.

In yet another aspect of the present disclosure, a method for endotracheal suctioning is disclosed. The method includes (1) providing a system, including: (a) a fluid delivery apparatus, including: (i) a fluid delivery chamber configured to contain a fluid; (ii) a fluid channel in fluid communication with said fluid delivery chamber; (iii) a fluid inlet configured to direct the fluid into said fluid delivery chamber; (iv) a fluid outlet in fluid communication with said fluid channel; and (v) a trifurcated fluid delivery connector (FDC) comprising first, second and third connected FDC lumens; wherein (i) said first FDC lumen is configured to connect to said fluid outlet, (ii) said second FDC lumen is configured to connect to an endotracheal tube (ETT), and (iii) said third FDC lumen is configured to connect to a ballard connector which is configured to facilitate suctioning by a ballard catheter; and wherein said fluid delivery chamber comprises a collapsible pleated bellows structure; and (b) a trifurcated ballard connector (BC) comprising first, second and third connected BC lumens; wherein (i) said first BC lumen is operably connected to the third FDC lumen, (ii) said second BC lumen is configured to connect to a ventilator, and (iii) said third BC lumen is configured to accommodate a ballard catheter; and (2)

connecting said second FDC lumen to an ETT engaged in a subject's airway; (3) connecting said second BC lumen to a ventilator; (4) connecting a second end of a ballard catheter to a vacuum; (5) connecting the fluid inlet of the fluid delivery apparatus to a fluid reservoir containing a rinsing fluid; (6) introducing a quantity of the rinsing fluid from said fluid reservoir into said fluid delivery apparatus; (7) introducing said rinsing fluid from said fluid delivery apparatus into said endotracheal tube and/or said subject's airway; and (8) suctioning secretions and/or rinsing fluid from said endotracheal tube and/or said subject's airway by utilizing said ballard catheter.

BRIEF DESCRIPTION OF THE DRAWINGS

Exemplary embodiments are illustrated in the referenced figures. It is intended that the embodiments and figures disclosed herein are to be considered illustrative rather than restrictive.

FIG. 1 illustrates an example of a system for an endotracheal suctioning that is constructed in accordance with the principles of this disclosure.

FIG. 2 illustrates an example of an endotracheal suctioning device for closed suctioning that is constructed in accordance with the principles of this disclosure.

FIG. 3 illustrates an example of a side perspective view an endotracheal suctioning device for closed suctioning.

FIG. 4 illustrates an example of an exploded view an endotracheal suctioning device for closed suctioning that is constructed in accordance with the principles of the present disclosure.

FIGS. 5A and 5B illustrate an example of a cross section of a manifold of an endotracheal suctioning device that is constructed in accordance with the principles of the present disclosure.. FIG. 6 illustrates an example of a cross section of a manifold of an endotracheal suctioning device that is constructed in accordance with the principles of the present disclosure..

FIG. 7 illustrates an example of an endotracheal suctioning system (also referred to herein as a fluid flow controller).

DETAILED DESCRIPTION OF THE INVENTION

All references cited herein are incorporated by reference in their entirety as though fully set forth. Unless defined otherwise, technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Szycher 's Dictionary of Medical Devices CRC Press, 1995, may provide useful guidance to many of the terms and phrases used herein. One skilled in the art will recognize many methods and materials similar or equivalent to those described herein, which could be used in the practice of the present invention. Indeed, the present invention is in no way limited to the methods and materials specifically described.

In some embodiments, properties such as dimensions, shapes, relative positions, and so forth, used to describe and claim certain embodiments of the invention are to be understood as being modified by the term "about."

Various examples of the disclosure will now be described. The following description provides specific details for a thorough understanding and enabling description of these examples. One skilled in the relevant art will understand, however, that the disclosure may be practiced without many of these details. Likewise, one skilled in the relevant art will also understand that the disclosure can include many other obvious features not described in detail herein. Additionally, some well-known structures or functions may not be shown or described in detail below, so as to avoid unnecessarily obscuring the relevant description.

The terminology used below is to be interpreted in its broadest reasonable manner, even though it is being used in conjunction with a detailed description of certain specific examples of the disclosure. Indeed, certain terms may even be emphasized below; however, any terminology intended to be interpreted in any restricted manner will be overtly and specifically defined as such in this Detailed Description section.

While this specification contains many specific implementation details, these should not be construed as limitations on the scope of any disclosures or of what may be claimed, but rather as descriptions of features specific to particular implementations of particular disclosures. Certain features that are described in this specification in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a subcombination or variation of a subcombination.

In some embodiments, the terms "a" and "an" and "the" and similar references used in the context of describing a particular embodiment of the application (especially in the context of certain of the following claims) can be construed to cover both the singular and the plural. The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (for example, "such as") provided with respect to certain embodiments herein is intended merely to better illuminate the application and does not pose a limitation on the scope of the application otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the application.

The terms "patient" and "subject" are used interchangeably herein. These terms are intended to include all animal subjects, including mammals. Human patients/subjects are intended to be within the scope of the patients/subjects treated using the various embodiments of the inventive systems, apparatuses and methods described herein.

A term "wireless transmitter," as used in this disclosure, means at least one of microwave, Infrared or RF module or a cellular/wireless modem and is configured to transmit data.

The term "coupled" means at least either a direct electrical connection between the connected items or an indirect connection through one or more passive or active intermediary devices. The term "circuit" means at least either a single component or a multiplicity of components, either active and/or passive, that are coupled together to provide a desired function. The term "signal" as used herein may include any meanings as may be understood by those of ordinary skill in the art, including at least an electric or magnetic representation of current, voltage, charge, temperature, data or a state of one or more memory locations as expressed on one or more transmission mediums, and generally capable of being transmitted, received, stored, compared, combined or otherwise manipulated in any equivalent manner.

Terms such as "providing," "processing," "supplying," "determining," "calculating" or the like may refer at least to an action of a computer system, computer program, signal processor, logic or alternative analog or digital electronic device that may be transformative of signals represented as physical quantities, whether automatically or manually initiated.

A "computer," as used in this disclosure, means any machine, device, circuit, component, or module, or any system of machines, devices, circuits, components, modules, or the like, which are capable of manipulating data according to one or more instructions, such as, for example, without limitation, a processor, a microprocessor, a central processing unit, a general purpose computer, a cloud, a super computer, a personal computer, a laptop computer, a palmtop computer, a mobile device, a tablet computer, a notebook computer, a desktop computer, a workstation computer, a server, or the like, or an array of processors, microprocessors, central processing units, general purpose computers, super computers, personal computers, laptop computers, palmtop computers, mobile devices, tablet computers, notebook computers, desktop computers, workstation computers, servers, or the like.

A "server," as used in this disclosure, means any combination of software and/or hardware, including at least one application and/or at least one computer to perform services for connected clients as part of a client-server architecture. The at least one server application may include, but is not limited to, for example, an application program that can accept connections to service requests from clients by sending back responses to the clients. The server may be configured to run the at least one application, often under heavy workloads, unattended, for extended periods of time with minimal human direction. The server may include a plurality of computers configured, with the at least one application being divided among the computers depending upon the workload. For example, under light loading, the at least one application can run on a single computer. However, under heavy loading, multiple computers may be required to run the at least one application. The server, or any if its computers, may also be used as a workstation.

A "database," as used in this disclosure, means any combination of software and/or hardware, including at least one application and/or at least one computer. The database may include a structured collection of records or data organized according to a database model, such as, for example, but not limited to at least one of a relational model, a hierarchical model, a network model or the like. The database may include a database management system application (DBMS) as is known in the art. The at least one application may include, but is not limited to, for example, an application program that can accept connections to service requests from clients by sending back responses to the clients. The database may be configured to run the at least one application, often under heavy workloads, unattended, for extended periods of time with minimal human direction.

A "communications network," as used in this disclosure, means a wired and/or wireless medium that conveys data or information between at least two points. The wired or wireless medium may include, for example, a metallic conductor link, a radio frequency (RF) communication link, an Infrared (IR) communication link, telecommunications networks, an optical communication link, internet (wireless and wired) or the like, without limitation. The RF communication link may include, for example, WiFi, WiMAX, IEEE 802.11, DECT, 0G, 1G, 2G, 3G, 4G, 5G or future cellular standards, Bluetooth, Bluetooth Low Energy, NFC, ultrasound, induction, laser (or similar optical transmission) and the like.

A "computer-readable storage medium," as used in this disclosure, means any medium that participates in providing data (for example, instructions) which may be read by a computer. Such a medium may take many forms, including non-volatile media, volatile media, and transmission media. Non-volatile media may include, for example, optical or magnetic disks, flash memory, and other persistent memory. Volatile media may include dynamic random access memory (DRAM). Transmission media may include coaxial cables, copper wire and fiber optics, including the wires that comprise a system bus coupled to the processor. Transmission media may include or convey acoustic waves, light waves and electromagnetic emissions, such as those generated during radio frequency (RF) and infrared (IR) data communications. Common forms of computer-readable media include, for example, a floppy disk, a flexible disk, hard disk, magnetic tape, any other magnetic medium, a CD-ROM, DVD, any other optical medium, punch cards, paper tape, any other physical medium with patterns of holes, a RAM, a PROM, an EPROM, a FLASH-EEPROM, any other memory chip or cartridge, a carrier wave as described hereinafter, or any other medium from which a computer can read. The computer-readable medium may include a "Cloud," which includes a distribution of files across multiple (e.g., thousands of) memory caches on multiple (e.g., thousands of) computers.

Various forms of computer readable media may be involved in carrying sequences of instructions to a computer. For example, sequences of instruction (i) may be delivered from a RAM to a processor, (ii) may be carried over a wireless transmission medium, and/or (iii) may be formatted according to numerous formats, standards or protocols, including, for example, WiFi, WiMAX, IEEE 802.11, DECT, 0G, 1G, 2G, 3G or 4G cellular standards, Bluetooth, or the like.

A "network," as used in this disclosure means, but is not limited to, for example, at least one of a local area network (LAN), a wide area network (WAN), a metropolitan area network (MAN), a personal area network (PAN), a campus area network, a corporate area network, a global area network (GAN), a broadband area network (BAN), a cellular network, the Internet, the cloud network, or the like, or any combination of the foregoing, any of which may be configured to communicate data via a wireless and/or a wired communication medium. These networks may run a variety of protocols not limited to TCP/IP, IRC, SSL, TLS, UDP, or HTTP.

Overview

In order to address all of the aforementioned issues, improved apparatuses, systems and methods for endotracheal suctioning have been developed, with three central areas of improvement. First, in some embodiments the systems and apparatuses have been designed to block suctioning or administering fluids without an electronic signal from the user, thereby allowing tracking of such activity on an electronic health record. Second, in some

embodiments, components for measuring fluids administered through the endotracheal tube for lavage/airway maintenance are incorporated into the apparatus. On this basis, alarms and limits on quantities can be set. Third, in some embodiments, the systems and apparatuses described herein are configured with components that alert staff when there is a drop in pressure in the ventilator circuit associated with suctioning and lavage. This enables staff to monitor staff-related ventilation disturbances separate from patient or ventilator related issues Closed Suctioning System

With the aforementioned background in mind, several improvements to previously available suctioning apparatuses, systems and methods are described herein below.

In various embodiments, the invention provides a closed suctioning system that includes a fluid delivery apparatus configured to store and deliver a medically useful fluid (e.g. physiologically appropriate saline) into an endotracheal tube and/or a subject's airway in order to facilitate the cleansing and suctioning process described above. In some embodiments, the fluid delivery apparatus may include a fluid delivery chamber configured to contain a medically useful fluid. In certain embodiments, the fluid delivery apparatus may further include a fluid channel in fluid communication with the fluid delivery chamber, and configured to accept fluid from the fluid delivery chamber. The apparatus may further include a fluid inlet configured to direct fluid into the fluid delivery chamber, and a fluid outlet in fluid communication with the aforementioned fluid channel. In some embodiments, the device may include a plunger configured to engage in the fluid delivery chamber. In various embodiments, the tip of the plunger may be made of a rubber (or a similar material), and it may be configured to form a substantially fluid tight seal with the interior of the fluid delivery chamber. With this configuration, when the plunger is depressed, fluid is advanced from the chamber through the fluid channel and out of the fluid outlet. In some embodiments, the fluid delivery apparatus may further includes a trifurcated fluid delivery connector (FDC) that includes first, second and third connected FDC lumens. In some embodiments, (1) the first FDC lumen may be configured to connect to the fluid outlet of the apparatus (directly or through any appropriate fitting - e.g. collar, or other fastener); the second FDC lumen may be configured to connect to an endotracheal tube (ETT) (directly or through any appropriate fitting - e.g. collar, or other fastener), and (2) the third FDC lumen may be configured to connect to a ballard connector (directly or through any appropriate fitting - e.g. collar, or other fastener), which is in turn configured to facilitate suctioning by a ballard catheter.

In various embodiments, the system may further include a trifurcated ballard connector (BC). In some embodiments, the BC includes first, second and third connected BC lumens. In some embodiments, the first BC lumen is operably connected to the third FDC lumen. In certain embodiments, the second BC lumen is configured to connect to a ventilator. In some embodiments, the third BC lumen is configured to accommodate a ballard catheter configured for suctioning secretions deposited in the endotracheal tube, or along a subject's airway.

Although some embodiments described herein include only a single plunger and chamber pair, in other embodiments, the apparatus includes multiple paired plungers and chambers configured to deliver fluid, as demonstrated in FIG. 4.

In some embodiments, the fluid delivery chamber(s) and plunger(s) may be housed within a compressible outer shell comprising at least two opposing and nesting spring loaded components, which are configured such that compression of the outer shell causes the plunger(s) to advance within the fluid delivery chamber(s) and thereby advance fluid contained therein through the fluid channel and out of the fluid outlet. In certain embodiments, the fluid inlet may include a one way inlet valve configured to deliver fluid into said fluid delivery chamber. In certain embodiments, the fluid outlet includes a one way outlet valve configured to receive fluid from said fluid channel. An exemplary embodiment of a fluid delivery apparatus with a one way inlet valve and a one way outlet is depicted in FIG. 4.

In still other embodiments of the systems described herein above and below, the plunger and chamber configuration of the portion of the apparatus configured to hold liquid may be replaced with a self-sprung pleated bellows unit, as exemplified by the self-sprung pleated bellows unit 203 depicted in FIG. 6. The remainder of the fluid delivery apparatus may be generally configured in the same manner as the apparatus described above (e.g. as shown in FIG. 6), and additional system components described below can be attached to any of the bellows- or plunger-based fluid delivery apparatuses described above.

In certain embodiments, the suctioning system may further include an ETT operatively connected to the second FDC lumen (directly or through any appropriate fitting - e.g. collar, or other fastener). In certain embodiments, the invention may further include a ballard catheter, said ballard catheter comprising a first end and a second end; wherein the first end of said ballard catheter may be configured to be introduced through (a) said BC, (b) said FDC, and (c) said ETT, such that the first end of said ballard catheter may be utilized to suction secretions located in a subject's airway and/or in the ETT, when the second end of the ballard catheter is connected to a vacuum source. In some embodiments, the system may further include a fluid reservoir; and a connecting tube; wherein said connecting tube connects said fluid reservoir to said fluid inlet.

In various embodiments, the system may include a fluid flow controller (FFC). In some embodiments, the FFC may control a lockable blocking component configured to prevent the flow of fluid from the fluid delivery apparatus to the ETT, when the lockable blocking element is locked. In some embodiments, the FFC may include or is operably connected to a pressure sensor or flow meter configured to measure the pressure of fluid flowing from the fluid delivery device towards the ETT.

In some embodiments, the FFC may include a wireless transmitter configured to transmit data concerning (a) the locking and/or unlocking of the lockable blocking component, and/or (b) fluid flow detected by the pressure sensor. In some embodiments, the wireless transmitter may be configured to send the data to a device or set of devices that can facilitate the inclusion of the data in an electronic health record. The wireless transmitter may transmit the data through a communications network to a server (or admin computer), a computing device, or a database, wherein the server, the computing device, or the database may include a patient's electronic health record. In some embodiments, the data may include one or more of time of suctioning, duration of suctioning, volume of liquid delivered, and the like. In some embodiments, the fluid delivery apparatus includes one or more switch or button for electronically controlling fluid flow. In some embodiments, the FFC, or one or more of the components with which it communicates, may be configured to intervene between the fluid delivery apparatus and the endotracheal tube. In some embodiments, the FFC, or one or more of the components with which it communicates, may be configured to intervene between the fluid source and the fluid delivery device. In yet other embodiments, an FFC (dark box connected to the network) can be configured within the system as demonstrated in FIG. 7 and described in the description of the drawings set forth above. Any FFC may be connected to a network (e.g. as shown in FIG. 7), or not connected to a network.

In various embodiments, the invention provides a method that includes, providing a system described above, and then connecting the second FDC lumen to an ETT engaged in a subject's airway. The method may further comprise, consist of, or consist essentially of: (1) connecting the second BC lumen to a ventilator; (2) connecting the second end of a ballard catheter to a vacuum; (3) connecting the fluid inlet of the fluid delivery apparatus to a fluid reservoir containing a rinsing fluid (or other medically useful fluid); (4) introducing a quantity of the rinsing fluid from the fluid reservoir into the fluid delivery apparatus; and (5) introducing the rinsing fluid from the fluid delivery apparatus into the endotracheal tube and/or the subject's airway. The method may then include suctioning secretions and/or rinsing fluid from the endotracheal tube and/or the subject's airway by utilizing the ballard catheter. Importantly, the order described above, in which the various components of the system are connected, is not intended to be limiting, so long as suctioning and ventilation are safely accomplished.

The fluid delivery apparatuses described herein can be used for numerous applications, and therefore they are intended to be stand-alone inventive devices, that may or may not be integrated into any systems described herein.

In various embodiments, the invention teaches a kit that comprises, consists of, or consists essentially of any system, apparatus, connector or controller described herein (or combinations thereof), and optionally instructions for the use thereof to suction fluids and/or secretions from a subject's airway and/or monitor and/or control the suctioning of a subject's airway through an endotracheal tube engaged therein. EXAMPLES

Example 1

Endotracheal suctioning system FIG. 1 shows an example of a system that is constructed according to the principles of the disclosure that provides wireless transmission of patient's data from FFC (or endotracheal device 10). The system 100 includes at least one endotracheal device 10A, a network 30, a monitor (e.g., a system manager) computer (or computing device) 40, a hosted server (or computer) 50, and a database 60, all of which may be coupled to each other via communication links 20. For instance, the hosted server 50 and database 60 may be connected to each other and/or the network 30 via one or more communication links 20. The at least one endotracheal device 10A and the monitor computer 40 may be coupled to the network 30 via communication links 20. The at least one endotracheal device 10A may be used by, for example, an authorized user (e.g., doctor, nurse, or the like) of a patient to whom the at least one endotracheal device 10A is being used.

The at least one endotracheal device 10A, the monitor computer 40, the hosted server 50, and the database 60 may each include a computer-readable medium including a computer program that may be executed to carry out the processes disclosed herein. The computer- readable medium may include a code section or code segment for performing each step disclosed herein, e.g., FIG. 7.

The at least one endotracheal device 10A may include a communications device to transmit the patient's data from the at least one endotracheal device 10A (or FFC). The communications device may include at least one of RF module or a cellular/wireless modem and is configured to transmit the at least one measured output to the monitor computer 40 (or the hosted server 50 and the database 60).

The software products residing on the hosted server 50 may be effective to, for example, generate a graphical user interface (not shown) such as the patient's electronic health record, a website and associated web pages to display data received from the at least one endotracheal device 10A (or FFC). Data from the at least one endotracheal device 10A may further be stored in the database 50 in an account associated with the patient and used for retrieving the patient, such as, electronic health record.

The data from the at least one endotracheal device may also be used for data trending or other statistical analysis or reporting. The hosted server 50 may further provide software products for downloading via the graphical user interface or by other known transmission media (or via third party servers such as for example conventionally known mobile application markets) to the communications device or a remote device (not shown) such that upon execution of a host-provided program the user may be able to remotely access data from the communications device or the remote device. The remote device may include any of a number of computing devices, such as, e.g., desktops, laptops, tablets, smart-phones, etc., as operable to download the software products and execute the associated program features as described herein.

Example 2

Endotracheal suctioning apparatus I In one exemplary embodiment, the fluid delivery device of the closed suctioning system is configured as depicted in FIG. 4. The fluid delivery device 100 depicted in FIG. 4 includes a three chamber manifold 106 (shown in lengthwise cross section in FIG. 5 A and widthwise cross section in FIG. 5B). The three chambers are configured to hold liquid which enters the fluid delivery device 100 through a low pressure one way inlet valve 204 located/included in the inlet port 107 (see FIGS. 4, 5 A and 5B, and FIG. 6). Each of the three chambers is in fluid communication with a fluid channel 113 which leads to an outlet valve 108 (see FIG. 5 A). The outlet valve 108 is a high pressure one way valve (relative to the inlet valve) through which liquid can be expelled (see FIGS. 4, 5 A and 5B). The fluid delivery apparatus 100 depicted in FIG. 3 further includes a trifurcated fluid delivery connector (FDC) component 110 with 3 connected lumens. The first lumen 110a is connected to the high pressure one way outlet valve 108. The second lumen 110b is configured to be connected to an endotracheal tube (ETT). The third lumen 110c is configured to be connected to a ballard catheter device connector.

As shown in FIG. 4, the three chamber manifold 106 is housed within an outer casing which includes three nesting shell components 101, 105, and 109. The nesting shell components include two opposing shells 105,106 that fit together around the three chamber manifold 106. The first shell 109 envelops the section of the three chamber manifold 106 that includes the fluid channel. The second shell 105 envelops the section of the manifold that includes the three chambers. The third shell 101 is configured to accommodate a section of the second shell 105, such that the second shell 105 can partially (or optionally completely) nest within the third shell 101. The third shell 101 also houses three syringes 104a-c and rubber syringe stoppers/tips 103a-c configured to form a substantially fluid tight seal and to glide along/traverse the three chambers of the manifold (as shown in FIG. 5 A) and thereby push fluid out of the three chambers and into the fluid channel 113. Return springs 102a,b allow shell components 101,105, 109 to return to their original position with respect to one another, such that the plungers 104a-c, 103a-c are not significantly engaged in the three chamber manifoldl06, when the outer casing is released after being compressed, to expel liquid from the three chambers of the manifold 106.

Example 3

Endotracheal suctioning apparatus II

FIG. 6 depicts an alternative exemplary embodiment of the fluid delivery device. As shown in FIG. 6, the plunger and chambers of the fluid delivery device depicted in FIG. 4 can be replaced by a self-sprung pleated bellows chamber 203 as depicted in FIG. 6. The low pressure one way inlet valve 204, high pressure one way outlet valve 205and trifurcated connector (including lumens 206a-206c) of the fluid delivery device 200 depicted in FIG. 6 are the same as those of the fluid delivery device 100 shown in FIG. 4. Similarly, the three nested shells 201, 202, 209 that make up the outer casing of the fluid delivery device 200 shown in FIG. 6 also function similarly to those of the fluid delivery device 100 of FIG. 4, but no plungers or springs are included, because the bellows system is self-sprung.

Example 3

Endotracheal suctioning systems Although the fluid storage aspects of the fluid delivery devices shown in FIGS. 4 and

6 are different, the integration of each device within a larger system for closed-suctioning is similar. More specifically, as shown in FIG. 2, the fluid delivery devices of FIG. 4 (100) or FIG. 6 (200) can be attached via the trifurcated connector to an endotracheal tube on one side (via 110b), and a trifurcated ballard catheter device connector on the other side 400. The trifurcated ballard catheter device connector can then be connected to a ventilator through lumen 402. A ballard catheter can then be connected to a vacuum at one end, and the other end can be introduced through a lumen 403 of the trifurcated ballard catheter device connector, then through the lumen 100c of the trifurcated fluid delivery connector , and finally into the endotracheal tube. The fluid delivery device of FIG. 4 or FIG. 6 could then be connected through the inlet 107/204 to a saline bag, via a connecting tube (such as an IV bag tube). In an exemplary embodiment, the system is configured as shown in FIG. 2, and connected to a saline bag, vacuum, and ventilator, as well as an endotracheal tube engaged in a subject's airway.

In some embodiments one or more of the saline bag, vacuum, ventilator, endotracheal tube, and fluid flow controller (as described above) are a part of the endotracheal suctioning system.

In practice, the fluid delivery apparatus can be primed with liquid from the saline bag by squeezing and releasing the casing of the fluid delivery apparatus (of FIG. 4 or FIG. 6). This process can be repeated, if necessary, to increase the volume of fluid introduced into the fluid delivery apparatus. Then, the fluid delivery apparatus can be compressed to inject a quantity of physiologically suitable saline through the trifurcated fluid delivery connector device, then into the endotracheal tube, and optionally into the subject's airway. One of skill in the art would readily appreciate that the amount of saline dispensed can vary, depending upon the size and age of the subject and the nature of the secretions to be cleared from the endotracheal tube and/or airway. After the quantity of saline is introduced into the endotracheal tube and/or airway of the patient, the ballard catheter connected to a vacuum is introduced through the components of the system (as described above) and into the region containing the secretions to be removed. The secretions are then suctioned by turning on the vacuum, and the process is repeated, if necessary.

Example 4

Simulation Testing of Closed Tracheal Suction Device

Scenario 1 - Simulation testing of airway obstruction, baseline (1 hour)

Materials:

• Gaumard high fidelity human simulator (electronic)

• Gaumard moderate fidelity human simulator (pressure-driven)

• 7.5 ET tube with patent interior

• 7.5 ET tube with plugged interior (called "7.5obs")

• MAC 4 laryngoscope

• Stylet

• PB 840 Ventilator

• Ventilator tubing

• Ventilator filters

Rooms:

• ICU room

• Multipurpose room (light will be shut for UV photograph)

Staff:

• Runner

• Recorder • Physician (setup of ventilator)

Methods:

• Ventilator settings: tidal volume 350 ml, rate 12, Square Flow Wave Form, Flow 55 L/min, PEEP 5, Assist Control / Volume Control.

· Simulators placed in supine position

High Fidelity Tests

• High fidelity ventilator set with maximum resistance, normal compliance

• Hi7.5 ET tube placed in simulated airway via MAC 4 laryngoscope, stylet removed

• PB Ventilator attached to 7.5 ET tube.

· Measurements taken of ventilator

• 7.5obs ET tube placed in simulated airway via MAC 4 laryngoscope, stylet removed

• PB Ventilator attached to 7.5 ETobs tube.

• Measurements taken of ventilator

• Tubing removed and photographed

Moderate Fidelity Tests

• High fidelity ventilator set with maximum resistance, normal compliance

• PB Ventilator attached to 7.5 ET tube.

• Measurements taken of ventilator

· 7.5obs ET tube placed in simulated airway via MAC 4 laryngoscope, stylet removed

• PB Ventilator attached to 7.5 ETobs tube.

• Measurements taken of ventilator

• Tubing removed and photographed with and without UV

Measurements:

· Ventilator

o Observed Rate

o Observed Vt

o Observed Flow

o PIP

o Plateau pressure: (inspiratory pause) introduced.

o Compliance

o Flow volume curves

o Pressure and volume curves (vs. time)

Expected findings:

· 7.5 ET findings:

o Elevated PIP

o Relatively preserved plateau

o PIP-Plateaus > 10 mm Hg

o Flow mechanics consistent with flow resistance

· 7.5 obs findings

o No tidal volume on 7.5 obs

o Repeated alarming consistent with total obstruction Table 1. Summary Grid of Scenario I

Results:

• 7.5 ET findings:

o Elevated PIP was observed

o Relatively preserved plateau was observed

o PIP -Plateaus > 10 mm Hg was observed

o Flow mechanics consistent with flow resistance was observed

• 7.5obs findings

o No tidal volume on '7.5 obs' was observed

o Repeated alarming consistent with total obstruction was observed

Scenario II - Mod Fidelity Leak testing of obstructed tube (30 minutes)

Materials:

• Gaumard moderate fidelity human simulator (pressure-driven)

• 7.5 ET tube with plugged interior (called "7.5obs") loaded with lOcc GloGerm

• MAC 4 laryngoscope

• Stylet

• PB 840 Ventilator

• Ventilator tubing

• Ventilator filters Rooms:

• ICU room

• Multipurpose room (light will be shut for UV photograph)

Staff:

• Runner

• Recorder

• Physician (setup of ventilator)

Methods:

• Simulator placed in supine position

Moderate Fidelity Tests

• High fidelity ventilator set with maximum resistance, normal compliance

• 7.5obs ET tube with GloGerm placed in simulated airway via MAC 4 laryngoscope, stylet removed

• PB Ventilator attached to 7.5 ETobs Obs tube.

• Measurements taken of ventilator

• Tubing removed and photographed with and without UV

Expected findings:

• Tube removed and photographed under UV light (Woods Lamp) shows no leakage.

• If plugged tube passes test, proceed to third scenario.

Table 2. Summary Grid of Scenario II

test ng o mo erate i e ty.

• Tube removed and photographed under UV light (Woods Lamp) shows leakage.

• If plugged tube passes test, proceed to third scenario. Due to concern for

contamination of moderate fidelity (mechanical) lungs, opted to bypass further mod fi testing. Scenario III - High Fidelity simulation of suctioning during airflow resistance (30 min) Materials:

• Gaumard high fidelity human simulator (pressure-driven)

· 7.5 ET tube with plugged interior (called "7.5obs")

• 7.5 ET tube

• MAC 4 laryngoscope

• Stylet

• PB 840 Ventilator

· Ventilator tubing

• Ventilator filters

Rooms:

• ICU room

• Multipurpose room (light will be shut for UV photograph)

Staff:

• Runner

• Recorder

• Sim Resp Therapist

• Physician (setup of ventilator)

Methods:

• Simulator placed in supine position

Moderate Fidelity Tests

· High fidelity ventilator set with maximum resistance, normal compliance

• PB Ventilator attached to 7.5 ET tube.

• Measurements taken of ventilator

• Respiratory technician asked to suction airway using only Ballard

· Mechanics unchanged in scenario.

• Mannequin reintubated with obstructed tube.

• Mechanics measured again (as per scenario I)

• Tube removed and photographed under UV light (Woods Lamp)

Expected findings:

· 2-step scenario produces baseline ventilator mechanics observed in I and II

Table 3. Summary Grid of Scenario III

PB Flow vs vol In place, recorded X

Vent tubing Vol, P vs t In place X

Vent filters In place X

Ballard In place X

Observations: Full spectrum light and UV light visualization of

equipment adequate. Waveforms consistent with obstructed tube. No GloGerm in place for this test.

Scenario IV - High fidelity simulation of suctioning during airflow resistance followed by full airway obstruction, Ballard alone This scenario operates in a "real time" with respiratory therapist and physician expected to manager an airway in need of urgent troubleshooting over flow resistance and suspected airflow obstruction.

Materials:

• Gaumard high fidelity human simulator

· 7.5 ET tube with plugged interior (called "7.5obs" loaded with GolGerm) x 20

• 7.5 ET tube

• MAC 4 laryngoscope

• Stylet

• PB 840 Ventilator

· Ventilator tubing x 10

• Ventilator filters x 10

• GloGerm

• Saline aliquots for suctioning

• Ballard device

Rooms:

• ICU room

• Multipurpose room (light will be shut for UV photograph)

Staff:

• Runner

· Recorder

• Sim Resp Therapist

• Physician (setup of ventilator)

Methods:

• Simulator placed in supine position

High Fidelity Tests with Ballard (IV-A)

• High fidelity ventilator set with maximum resistance, normal compliance

• Hi7.5 ET tube placed in simulated airway via MAC 4 laryngoscope, stylet removed · PB Ventilator attached to 7.5 ET tube.

• Measurements taken of ventilator

• Mannequin reintubated with obstructed tube.

• Technician attempts suctioning using Ballard and saline

• Mechanics measured again (as per scenario I)

· 8 cycles repeated Expected findings:

• Contamination was observed

Table 4. Summary Grid of Scenario IV

Ratings: 0 - 0 contamination; 1 - 1 surface; 2 - 2 surfaces; 3 - 3 surfaces

Multiple Surfaces Contaminated as shown in, e.g., FIGS. 12A, 12B, 12C, and 12D. Scenario V - High fidelity simulation of suctioning during airflow resistance followed by full airway obstruction, closed suction device

This scenario operates in a "real time" with respiratory therapist and physician expected to manager an airway in need of urgent troubleshooting over flow resistance and suspected airflow obstruction.

Materials:

• Gaumard high fidelity human simulator

• 7.5 ET tube with plugged interior (called "7.5obs" loaded with GolGerm) x 20 · 7.5 ET tube

• MAC 4 laryngoscope

• Stylet

• PB 840 Ventilator

• Ventilator tubing x 10

· Ventilator filters x 10

• GloGerm

• Saline aliquots for suctioning

• Ballard device

• Closed suction device

Rooms:

• ICU room

• Multipurpose room (light will be shut for UV photograph)

Staff:

• Runner

· Recorder

• Sim Resp Therapist

• Physician (setup of ventilator)

Methods:

• Simulator placed in supine position

High Fidelity Tests with Ballard and Closed Suction Device

• High fidelity ventilator set with maximum resistance, normal compliance

• Measurements taken of ventilator

• Mannequin reintubated with obstructed tube.

• Technician attempts suctioning using Ballard and saline

• Mechanics measured again (as per scenario I)

· 10 cycles repeated

Expected findings:

• No contamination observed Table 5. Summary Grid of Scenario V

Ratings: 0 - 0 contamination; 1 - 1 surface; 2 - 2 surfaces; 3 - 3 surfaces

P< 0.02 compared to 8 paired items (no contamination with Closed Device)

No external contamination was detected. The filters, the setup, and the ballard cap (unopened during the procedure), all had no contamination.

Interpretation of results.

In the final comparisons of closed suction setups and Ballard-alone setups, the contamination was scored by numbers of external surfaces (connector, glove, surface of tube, clothing or Ballard cap). Scores ranged from 0-3. Due to the presence of zero scores and grades of contamination, a paired t-test was applied rather than a chi-Square. For paired t-tests, the p value was less than 0.02. This was largely due to the absence in all samples of the closed suction device of external contamination. Surprisingly, glove and surface contamination was more noticeable than cap contamination. However, this was a small sample, large enough to detect a difference but far too small to identify relative rates of contamination.

Early in the training phase of the testing, there was gross contamination when Ballard sheaths and patient gowns. These score were not included as they were part of the training phase. However, it is fair to note that if the Ballard suctioning is done with large aliquots and the suction catheter in a dependent fashion relative to the t-connector, it can reliably reproduce large surface contamination. This contamination was not readily visible without UV light-enhanced imaging, though it was obvious during the suctioning due to spray and moisture accumulation. Because suction fluids are frequently serous and partially

transparent, it is important to note that the partial contamination rendered in the final testing is probably an under-estimate of contamination done by untrained or undisciplined individuals.

Conclusion

In conclusion, the simulation testing of the closed suction device eliminated an important source of surface contamination— human error. It was demonstrated that Ballard devices in common use by a respiratory therapist and physician can lead to surface contamination and that contamination can be effectively simulated and documented with high-fidelity devices and simulation protocols.

The various methods and techniques described above provide a number of ways to carry out the invention. Of course, it is to be understood that not necessarily all objectives or advantages described can be achieved in accordance with any particular embodiment described herein. Thus, for example, those skilled in the art will recognize that the methods can be performed in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other objectives or advantages as taught or suggested herein. A variety of alternatives are mentioned herein. It is to be understood that some embodiments specifically include one, another, or several features, while others specifically exclude one, another, or several features, while still others mitigate a particular feature by inclusion of one, another, or several advantageous features.

Furthermore, the skilled artisan will recognize the applicability of various features from different embodiments. Similarly, the various elements, features and steps discussed above, as well as other known equivalents for each such element, feature or step, can be employed in various combinations by one of ordinary skill in this art to perform methods in accordance with the principles described herein. Among the various elements, features, and steps some will be specifically included and others specifically excluded in diverse embodiments.

Although the application has been disclosed in the context of certain embodiments and examples, it will be understood by those skilled in the art that the embodiments of the application extend beyond the specifically disclosed embodiments to other alternative embodiments and/or uses and modifications and equivalents thereof.

Certain embodiments of this application are described herein, including the best mode known to the inventors for carrying out the application. Variations on those embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. It is contemplated that skilled artisans can employ such variations as appropriate, and the application can be practiced otherwise than specifically described herein. Accordingly, many embodiments of this application include all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the application unless otherwise indicated herein or otherwise clearly contradicted by context.

All patents, patent applications, publications of patent applications, and other material, such as articles, books, specifications, publications, documents, things, and/or the like, referenced herein are hereby incorporated herein by this reference in their entirety for all purposes, excepting any prosecution file history associated with same, any of same that is inconsistent with or in conflict with the present document, or any of same that may have a limiting affect as to the broadest scope of the claims now or later associated with the present document. By way of example, should there be any inconsistency or conflict between the description, definition, and/or the use of a term associated with any of the incorporated material and that associated with the present document, the description, definition, and/or the use of the term in the present document shall prevail.

In closing, it is to be understood that the embodiments of the application disclosed herein are illustrative of the principles of the embodiments of the application. Other modifications that can be employed can be within the scope of the application. Thus, by way of example, but not of limitation, alternative configurations of the embodiments of the application can be utilized in accordance with the teachings herein. Accordingly,

embodiments of the present application are not limited to that precisely as shown and described.

Claims

What is claimed is:

1. A system for endotracheal suctioning, the system comprising:

(1) a fluid delivery apparatus that comprises:

(a) a fluid delivery chamber configured to contain a fluid;

(b) a fluid channel in fluid communication with said fluid delivery chamber;

(c) a fluid inlet configured to direct the fluid into said fluid delivery chamber;

(d) a fluid outlet in fluid communication with said fluid channel;

(e) a plunger configured to engage in said fluid delivery chamber and advance the fluid contained therein through said fluid channel and out of said fluid outlet; and

(f) a trifurcated fluid delivery connector (FDC) comprising first, second and third connected FDC lumens, wherein (i) said first FDC lumen is configured to connect to said fluid outlet, (ii) said second FDC lumen is configured to connect to an endotracheal tube (ETT), and (iii) said third FDC lumen is configured to connect to a ballard connector which is configured to facilitate suctioning by a ballard catheter; and

(2) a trifurcated ballard connector (BC) comprising first, second and third connected BC lumens; wherein (i) said first BC lumen is operably connected to the third FDC lumen, (ii) said second BC lumen is configured to connect to a ventilator, and (iii) said third BC lumen is configured to accommodate a ballard catheter.

2. The system of claim 1, wherein said fluid delivery chamber and plunger are housed within a compressible outer shell comprising at least two opposing and nesting spring loaded components, which are configured such that compression of the outer shell causes the plunger to advance within the fluid delivery chamber and thereby advance fluid contained therein through said fluid channel and out of said fluid outlet.

3. The system of claim 2, wherein said fluid inlet comprises a one way inlet valve that is configured to deliver fluid into said fluid delivery chamber.

4. The system of claim 3, wherein said fluid outlet comprises a one way outlet valve configured to receive fluid from said fluid channel.

5. The system of claim 4, further comprising an ETT operatively connected to said second FDC lumen.

6. The system of claim 5, further comprising a ballard catheter, said ballard catheter comprising a first end and a second end; wherein the first end of said ballard catheter is configured to be introduced through (a) said BC, (b) said FDC, and (c) said ETT, such that the first end of said ballard catheter can be utilized to suction secretions located in a subject's airway and/or in the ETT, when the second end of the ballard catheter is connected to a vacuum source.

7. The system of claim 6, further comprising:

a fluid reservoir; and

a connecting tube; wherein said connecting tube connects said fluid reservoir to said fluid inlet.

8. The system of claim 7, further comprising a fluid flow controller (FFC) configured to regulate the flow of fluid to the ETT.

9. The system of claim 8, wherein the FFC is configured to electronically record data indicating one or more of (a) the time and/or date fluid was introduced into the ETT, (b) the amount of fluid introduced into the ETT, or (c) the rate at which fluid was introduced into the ETT.

10. The system of claim 9, wherein the FFC is configured to electronically communicate recorded data to a computing device.

11. The system of claim 10, wherein the electronic communication is wireless.

12. A method for endotracheal suctioning, comprising:

(1) providing a system for endotracheal suctioning, comprising:

(a) a fluid delivery apparatus, comprising:

(i) a fluid delivery chamber configured to contain a fluid;

(ii) a fluid channel in fluid communication with said fluid delivery chamber;

(iii) a fluid inlet configured to direct the fluid into said fluid delivery chamber;

(iv) a fluid outlet in fluid communication with said fluid channel;

(v) a plunger configured to engage in said fluid delivery chamber and advance the fluid contained therein through said fluid channel and out of said fluid outlet; and

(vi) a trifurcated fluid delivery connector (FDC) comprising first, second and third connected FDC lumens; wherein (i) said first FDC lumen is configured to connect to said fluid outlet, (ii) said second FDC lumen is configured to connect to an endotracheal tube (ETT), and (iii) said third FDC lumen is configured to connect to a ballard connector which is configured to facilitate suctioning by a ballard catheter; and (b) a trifurcated ballard connector (BC) comprising first, second and third connected BC lumens; wherein (i) said first BC lumen is operably connected to the third FDC lumen, (ii) said second BC lumen is configured to connect to a ventilator, and (iii) said third BC lumen is configured to accommodate the ballard catheter;

(2) connecting said second FDC lumen to an ETT engaged in a subject's airway;

(3) connecting said second BC lumen to a ventilator;

(4) connecting a second end of a ballard catheter to a vacuum;

(5) connecting the fluid inlet of the fluid delivery apparatus to a fluid reservoir containing a rinsing fluid;

(6) introducing a quantity of the rinsing fluid from said fluid reservoir into said fluid delivery apparatus;

(7) introducing said rinsing fluid from said fluid delivery apparatus into said endotracheal tube and/or said subject's airway; and

(8) suctioning secretions and/or rinsing fluid from said endotracheal tube and/or said subject's airway by utilizing the vacuum via the ballard catheter.

A system for endotracheal suctioning, comprising:

(1) a fluid delivery apparatus, comprising:

(a) a fluid delivery chamber configured to contain a fluid;

(b) a fluid channel in fluid communication with said fluid delivery chamber;

(d) a fluid outlet in fluid communication with said fluid channel; and

(e) a trifurcated fluid delivery connector (FDC) comprising first, second and third connected FDC lumens; wherein (i) said first FDC lumen is configured to connect to said fluid outlet, (ii) said second FDC lumen is configured to connect to an endotracheal tube (ETT), and (iii) said third FDC lumen is configured to connect to a ballard connector which is configured to facilitate suctioning by a ballard catheter; and wherein said fluid delivery chamber comprises a collapsible pleated bellows structure; and

14. The system of claim 13, wherein said fluid delivery chamber is housed within an outer shell comprising at least two opposing and nesting components, which when compressed cause said collapsible pleated bellows structure to collapse and thereby advance fluid contained therein through said fluid channel and out of said fluid outlet.

15. The system of claim 14, wherein said fluid inlet comprises a one way inlet valve configured to deliver fluid into said fluid delivery chamber.

16. The system of claim 15, wherein said fluid outlet comprises a one way outlet valve configured to receive fluid from said fluid channel.

17. The system of claim 16, further comprising an ETT operatively connected to said second FDC lumen.

18. The system of claim 17, further comprising a ballard catheter, said ballard catheter comprising a first end and a second end; wherein the first end of said ballard catheter is configured to be introduced through (a) said BC, (b) said FDC, and (c) said ETT, such that the first end of said ballard catheter can be utilized to suction secretions located in a subject's airway and/or in the ETT, when the second end of the ballard catheter is connected to a vacuum source.

19. The system of claim 18, further comprising:

(1) a fluid reservoir; and

(2) a connecting tube; wherein said connecting tube connects said fluid reservoir to said fluid inlet.

20. The system of claim 19, further comprising a fluid flow controller (FFC) that is configured to regulate the flow of fluid to the ETT.

21. The system of claim 20, wherein the FFC is configured to electronically record data indicating one or more of (a) the time and/or date fluid was introduced into the ETT, (b) the amount of fluid introduced into the ETT, or (c) the rate at which fluid was introduced into the ETT.

22. The system of claim 21, wherein the FFC is configured to electronically communicate the recorded data to a computing device.

23. The system of claim 22, wherein the electronic communication is wireless.

24. A method, comprising:

(1) providing a system, comprising:

(a) a fluid delivery apparatus, comprising:

(i) a fluid delivery chamber configured to contain a fluid;

(ii) a fluid channel in fluid communication with said fluid delivery chamber;

(iv) a fluid outlet in fluid communication with said fluid channel; and

(v) a trifurcated fluid delivery connector (FDC) comprising first, second and third connected FDC lumens; wherein (i) said first FDC lumen is configured to connect to said fluid outlet, (ii) said second FDC lumen is configured to connect to an endotracheal tube (ETT), and (iii) said third FDC lumen is configured to connect to a ballard connector which is configured to facilitate suctioning by a ballard catheter; and wherein said fluid delivery chamber comprises a collapsible pleated bellows structure; and

(b) a trifurcated ballard connector (BC) comprising first, second and third connected BC lumens; wherein (i) said first BC lumen is operably connected to the third FDC lumen, (ii) said second BC lumen is configured to connect to a ventilator, and (iii) said third BC lumen is configured to accommodate a ballard catheter; and

(2) connecting said second FDC lumen to an ETT engaged in a subject's airway;

(3) connecting said second BC lumen to a ventilator;

(4) connecting a second end of a ballard catheter to a vacuum; (5) connecting the fluid inlet of the fluid delivery apparatus to a fluid reservoir containing a rinsing fluid;

(8) suctioning secretions and/or rinsing fluid from said endotracheal tube and/or said subject's airway by utilizing said ballard catheter.