This disclosure relates to devices for the delivery of apneic oxygenation and suction, and more specifically devices for delivery of apneic oxygenation and on-demand suction through an endotracheal tube during the process of intubation.
Airway intubation is the placement of an endotracheal tube into a patient's airway to a depth below the vocal cords. It is a procedure that can occur electively in order to protect the airway and respiration of a patient during surgery or can occur in a critical illness. It is a high-risk procedure as it occurs when patients are apneic (not breathing) either due to their illness or from medications, and a narrow time window is available to the intubator prior to a dangerous decrease in the patient's blood oxygen levels, which significantly are worsened in the presence of disease. An intubation attempt may be prolonged due to airway anatomy that either prevents good visualization of the airway or due to difficulty advancing the endotracheal tube. It may also be prolonged if fluids (secretions or blood) obscure the intubator's view of the endotracheal tube's path, requiring a suction catheter to be introduced into the patient's mouth.
Apneic oxygenation is the delivery of flowing oxygen into a patient's nares via nasal cannula tubing during intubation attempts, and provides a proven safety benefit by delaying the time to oxygen desaturation. This oxygen flow can be blocked by the same airway conditions or fluids mentioned above, negating this safety benefit. Therefore, providing a tracheal intubation device that can, while being inserted into the patient's airway, be switched by the clinician from delivering oxygen and providing suction if needed would be very advantageous and increase the safety of the insertion procedure.
Provided is a tracheal intubation device designed to improve safety during intubation attempts. The device allows for the delivery of oxygen (or other medical gas) flow through the endotracheal tube (or through a laryngeal mask airway or other supraglottic device that secures a patient's airway) itself during intubation attempts. This moves the source of apneic oxygen lower in the patient's airway to bypass nasopharynx anatomy that otherwise can obstruct oxygen flow. The device can also switch on-demand to generating suction through the endotracheal tube to clear away fluids that block the intubator's view and that block oxygen flow. There are currently no devices that can deliver both oxygen and on-demand suction using the endotracheal tube as the flow conduit during the process of intubation. The present device accomplishes these tasks while incorporating non-obvious elements to optimize its use and efficacy.
The present device comprises an endotracheal tube adaptor that connects to the patient-exterior-end of the endotracheal tube, a control unit that connects to standard medical gas and suction tubing and controls medical gas and suction delivery, and a length of lightweight flexible tubing that connects the adaptor to the control unit.
During intubation, a semi-rigid stylet is placed within the endotracheal tube to make it rigid enough to allow it to advance rather than bending as it slides along airway surfaces. The distal end of this stylet sits at the airway-end of the endotracheal tube, while the proximal end of the stylet emerges from the patient-exterior-end of the endotracheal tube, and prevents the application of oxygen supply tubing to the endotracheal tube. Our device's adaptor to the patient-exterior-end of the endotracheal tube allows for a stylet using an in-line self-sealing minimal-leak port, allowing oxygen flow or suction to occur via a second off-axis adaptor conduit.
An intubation requires the clinician to use one hand to control a laryngoscope (a blade with a light source) to generate a view of the airway, and the other hand to manipulate the endotracheal tube towards the vocal cords. Our device utilizes lightweight flexible tubing to connect its endotracheal tube adaptor to a control unit. The on-demand suction control components as well as bulky tubing running from medical gas and suction sources are thus kept away from the patient-exterior-end of the endotracheal tube. This maintains a clear visual axis for the intubator, and ensures that the endotracheal tube does not become difficult to manipulate, as it would if the mass of these components were added directly to its patient-exterior-end. It allows an assistant to activate on-demand suction at a location where their manipulation of the device will not obscure the intubator's view or create traction on the endotracheal tube that would make it more difficult to manipulate.
The application of high pressures into a patient's airway can cause airway tissue damage (barotrauma). The present control device contains a pressure-release valve that activates automatically if pressure within the flexible tubing rises above a set level, thus preventing barotrauma.
Thus disclosed herein is an airway device for delivering medical gas to a patient, comprising:
The device medical gas input control unit may further comprise a suction supply coupling located at the first end of the housing and being connectable to a source of suction, and the control unit may include a hand-operated control mechanism for controlling both suction and medical gas flow.
The hand-operated control mechanism may be a finger activated switch for switching between the source of suction and the source of medical gas, and the control unit may be configured such that when the finger activated mechanism is not activated, medical gas flows to the airway access device, and when activated the medical gas flow is stopped and suction is applied to the airway access device, so that medical gas and suction cannot be provided at the same time.
The hand-operated control mechanism may be a finger activated switch for switching between the source of suction and the source of medical gas and the control unit may be configured such that when the finger activated mechanism is not activated, medical gas flows to the airway access device, and when activated the medical gas flow is reduced to a preselected flow rate and suction is simultaneously applied to the airway access device, so that medical gas and suction are provided at the same time.
The airway access device adaptor may be connected to, and in flow communication with, the airway access device by means of elongate flexible tubing.
The pressure limiting device may be any one of a pressure relief valve, a pressure regulating valve, a rupture disc, an aperture, or a breather vent.
The airway access device may be any one of an endotracheal tube, Laryngeal mask airway, tracheostomy tube, nasopharyngeal airway or tube, oropharyngeal tube, cricothyrotomy tube, and the like.
The present disclosure provides an airway device for delivering medical gas to a patient, comprising:
The hand-operated control mechanism may be a finger activated switch for switching between the source of suction and the source of medical gas, the control unit being configured such that when the finger activated mechanism is not activated, medical gas flows to the airway access device, and when activated the medical gas flow is stopped and suction is applied to the airway access device, so that medical gas and suction cannot be provided at the same time.
The hand-operated control mechanism may be a finger activated switch for switching between the source of suction and the source of medical gas, the control unit being configured such that when the finger activated mechanism is not activated, medical gas flows to the airway access device, and when activated the medical gas flow is reduced to a preselected flow rate and suction is simultaneously applied to the airway access device, so that medical gas and suction are provided at the same time.
The airway access device adaptor may be connected to, and in flow communication with, the airway access device by means of elongate flexible tubing.
The pressure limiting device may be any one of a pressure relief valve, a pressure regulating valve, a rupture disc, an aperture, or a breather vent.
The airway access device may be any one of an endotracheal tube, Laryngeal mask airway, tracheostomy tube, nasopharyngeal airway or tube, oropharyngeal tube, cricothyrotomy tube, and the like.
The present disclosure provides an airway device for delivering medical gas to a patient, comprising:
The medical gas input control unit may further comprise a suction supply coupling located at the first end of the housing and being connectable to a source of suction, the control unit including a hand-operated control mechanism for controlling both suction and medical gas flow.
The pressure limiting device may be a pressure relief valve is located adjacent to the second end of the housing with the medical gas supply coupling being located between said pressure relief valve and said suction supply coupling.
The suction supply coupling may be located adjacent to the first end of the housing, and wherein the medical gas supply coupling is located adjacent to the second opposed end, and wherein said pressure limiting device is a pressure relief valve located between the medical gas supply coupling and the suction supply coupling.
A further understanding of the functional and advantageous aspects of the disclosure can be realized by reference to the following detailed description and drawings.
The disclosure will be more fully understood from the following detailed description thereof taken in connection with the accompanying drawings, which form part of this application, and in which:
The devices described herein are directed, in general, to tracheal intubation devices and more specifically to tracheal intubation devices for delivery of apneic oxygenation (or other medical gases) and on-demand suction. Although embodiments of the present invention are disclosed herein, the disclosed embodiments are merely exemplary and it should be understood that the invention relates to many alternative forms, including different shapes and sizes. Furthermore, the Figures are not drawn to scale and some features may be exaggerated or minimized to show details of particular features while related elements may have been eliminated to prevent obscuring novel aspects. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting but merely as a basis for the claims and as a representative basis for enabling someone skilled in the art to employ the present invention in a variety of manners.
As used herein, the terms “comprises”, “comprising”, “includes” and “including” are to be construed as being inclusive and open ended, and not exclusive. Specifically, when used in this specification including claims, the terms “comprises”, “comprising”, “includes” and “including” and variations thereof mean the specified features, steps or components are included. These terms are not to be interpreted to exclude the presence of other features, steps or components.
As used herein, the terms “about” and “approximately”, when used in conjunction with ranges of dimensions, compositions of mixtures or other physical properties or characteristics, is meant to cover slight variations that may exist in the upper and lower limits of the ranges of dimensions so as to not exclude embodiments where on average most of the dimensions are satisfied but where statistically dimensions may exist outside this region. It is not the intention to exclude embodiments such as these from the present invention.
As used herein, the coordinating conjunction “and/or” is meant to be a selection between a logical disjunction and a logical conjunction of the adjacent words, phrases, or clauses. Specifically, the phrase “X and/or Y” is meant to be interpreted as “one or both of X and Y” wherein X and Y are any word, phrase, or clause.
As used herein the phrase “airway access device” refers to any medical device used by a clinician to access a patient's airway. Thus the airway access device may include any of, but is not limited to, an endotracheal tube, Laryngeal mask airway, tracheostomy tube, nasopharyngeal airway or tube, oropharyngeal tube, cricothyrotomy tube, and the like.
While the following disclosure and figures illustrates the present airway device for delivering medical gas and suction to a patient using an endotracheal tube as the airway access device, it will be appreciated that with minor design modifications the present device can be adapted for any airway access device, such as, but not limited, to those mentioned above.
The tracheal intubation device of the present disclosure, an embodiment of which is shown in
The endotracheal tube adaptor 12 of the present disclosure, an embodiment of which is shown in
The airway connector 20 is shaped such that the patient-exterior end 30 of an endotracheal tube 28 can be removably attached to the airway connector 20 such that medical gas and/or suction may be conducted through the airway connector between the airway end 32 of the endotracheal tube 28 and the body chamber 26. In a preferred embodiment, the airway connector 20 is cylindrical and is shaped such that the universal 15 mm diameter connector of an endotracheal tube or laryngeal mask airway or other supraglottic airway device can be removably attached by snug fit to the airway connector 20. In the embodiment of the disclosure shown in
The stylet accommodator 22 is attached to the body 18 of the endotracheal tube adaptor 12 and allows a semi-rigid stylet 34 to be removably positioned within the endotracheal tube 28 during intubation to make the endotracheal tube 28 rigid enough to allow it to advance into the airway rather than bending on airway surfaces. The diameter of the endotracheal tube 28 is greater than the diameter of the stylet 34 allowing medical gas or suction to be delivered during intubation. The stylet accommodator 22 is a self-sealing minimal-leak port, allowing medical gas and suction flow between the tubing component 14 and the endotracheal tube 28 via the endotracheal tube adaptor 12.
In the embodiment of the disclosure shown in
In an alternate embodiment of the disclosure, the stylet accommodator 22 is a removable plastic cap with a hole in the center of said cap so an intubation stylet can be inserted into the endotracheal tube through the hole in said cap. It will be appreciated by one skilled in the art that a cap with no hole in it can be used if the device of the present disclosure is being used without an intubation stylet.
The tubing port 24 is attached to the body 18 of the endotracheal tube adaptor 12 and is shaped such that the tubing component 14 can is removably attachable to the endotracheal tube adaptor 12. The tubing port 24 conducts medical gas flow or suction between the body chamber 26 of the endotracheal tube adaptor 12 and the tubing component 14. In a preferred embodiment shown in
In the embodiment of the present disclosure shown in
The tubing component 14, an embodiment of which is shown in
The control unit 16, shown in
The body 38 of the control unit 16 has a hollow main chamber 50 made of rigid material. In a preferred embodiment, the body 38 is a cylinder.
In the embodiment of the present disclosure shown in
The control apparatus 40 enables an operator to switch from medical gas supply to on-demand suction. In the embodiment shown in
In the embodiment of the disclosure shown in
The medical gas input port 42 attaches to the body 38 of the control unit 16 such that a medical gas supply tube is attachable to the medical gas input port 42 and medical gas is able to flow from a medical gas supply tube through the medical gas input port 42 into the main chamber 50. In the embodiment shown in
The suction port 44 attaches to the body 38 of the control unit 16 such that a suction supply tube is attachable to the suction port and suction is able to be supplied to the suction chamber 52 of the control unit 16. The suction port enables the flow of matter and medical gas from the suction chamber 52 through the suction port 44 into the suction supply tube if the control apparatus 54 is activated. In the embodiment shown in
The tubing component port 46 is attached to the body 38 such that the end of the tubing component 14 that is not attached to the endotracheal tube adaptor 12 is removably attached to the tubing component port 46. The tubing component port 46 enables medical gas flow or suction to be conducted between the main chamber 50 of the control unit 16 and the tubing component 14. In the embodiment shown in
The pressure release valve 48 is attached to the body 38 such that the valve opens if the pressure within the main chamber 50 is above a predetermined level. When the pressure release valve 48 is opened, any pressure throughout the tracheal intubation device 10 that is above the setting on the pressure release valve 48 is released. The pressure release valve 48 opens to release pressure within the tracheal intubation device 10 if the pressure within the system is at a dangerous level, decreasing the risk of barotrauma (tissue damage in the airway due to high pressure). It will be appreciated by those skilled in the art that a cap may be placed around the pressure release valve 48 to disable the pressure release valve 48. By setting the flow of medical gas into the device at a level that leads to opening of the pressure release valve 48, the device will also provide continuous positive airway pressure at a level determined by the setting of the pressure release valve 48. This pressure release valve 48 may have a single pressure level at which it opens, or may be of an adjustable design to allow it to open at any selected pressure level within a range of pressures, 1 cm H20 to 100 cm H20, for example.
In an alternate embodiment of the endotracheal intubation device shown in
In
It will be appreciated by those skilled in the art that any other elastic object with a similar function to the spring 100 may be used so that the apparatus automatically returns to a default state. For example, sponge can be used instead of a spring. Alternatively, it will also be appreciated by those skilled in the art that the control apparatus 84 of the control unit 72 does not need an automatic return mechanism if it is not desirable.
In
It will be appreciated by those skilled in the art that any other channel selection feature with a similar function to a stopcock may be used so that the control apparatus automatically returns to a default state. Alternatively, it will also be appreciated by those skilled in the art that the channel selector of the control unit does not need an automatic return mechanism if it is not desirable.
In
The channel selector 132 also preferably possesses an automatic return feature such that once the channel selector 132 is no longer actively engaged, the channel selector 132 returns to the default state in which medical gas flow is communicated to the medical gas channel 134 within the body and suction is blocked from communicating with the suction channel 136 within the body of the control unit. In this embodiment, the tubing component consists of two separate channels, one for medical gas flow 138 and one for suction 140, and the tubing attachment of the endotracheal tube adaptor is different from tubing attachment 24, such that it is compatible with the tubing component of the present embodiment. In the present embodiment, the medical gas tube and suction tube may be connected to form one dual channel tubing component. This dual channel tubing may consist of side-by-side channels, or one smaller diameter channel dwelling within one large diameter channel.
It will be appreciated by those skilled in the art that any other channel selection feature with a similar function to a stopcock may be used so that the apparatus automatically returns to a default state. Alternatively, it will also be appreciated by those skilled in the art that the channel selector of the control unit does not need an automatic return mechanism if it is not desirable.
In addition, it will be understood that the present tracheal intubation device may be produced without suction and the associated suction control, and instead provides only medical gas supply and its associated control unit.
Another tracheal intubation device 142 is shown in
An embodiment of the present disclosure is shown in
In an alternate embodiment of the disclosure, the tracheal intubation device may be included in a portable unit 158 with stand-alone medical gas and suction supplies, as shown in
Another embodiment of the system is shown in
A medical gas input port 208 and suction input port 210 are connected to the control apparatus 204, shown in
The control apparatus 204 is an off-the-shelf spring-return 5-way valve with two input ports 240 and 242, and three output ports 244, 246, and 248, shown in
Shown in
Control apparatus 204 output port 244 is connected to internal body channel 250 via an internal pipe connector 212, control apparatus 204 output port 246 is connected to internal body channel 252 via an internal pipe connector 212, and control apparatus 204 output port 248 is connected to internal body channel 254 via an internal pipe connector 212, as shown in
The control apparatus 204 enables an operator to switch from medical gas supply to on-demand suction. The device is configured to deliver medical gas when in the non-activated state. As shown in
The body extension 226 protects an operator from unintentionally preventing suction flow from entering the exhaust port 222. The dedicated suction channel 250 and suction output port 220 are idle in this non-activated configuration, and only medical gas is delivered to the patient.
In the activated configuration shown in
An embodiment of the present disclosure is shown in
Shown in
Shown in
Ventilation includes both conventional and non-conventional modalities. Non-conventional modalities including but not limited to high frequency oscillation (HFO) in which delivered medical gas is rapidly moved back and forth to provide active inspiration and active expiration. The oscillation is achieved using mechanical methods such as a piston, membrane, flow interrupter, or switching valves. Non-conventional modalities also include high or low frequency jet ventilation, in which high pressured medical gas is intermittently delivered by means of flow interruption. High frequency jet ventilation achieves flow interruption by mechanical methods such as solenoid valves, fluidic or rotating valves, and other pneumatically or electronically controlled devices. Low frequency jet ventilation is typically achieved by hand-triggered flow interruption devices. The control unit of the present airway device for delivering medical gas to a patient can be readily modified to operate in these non-conventional modalities. For example, the present control unit may be modified as disclosed above to deliver gas in any of these non-conventional modalities.
In an embodiment the present disclosure provides an airway access device configured to be coupled to a patient's airway and which comprises;
In an embodiment the device medical gas input control unit further comprises a suction supply coupling located at the first end of the housing and being connectable to a source of suction, and the control unit may include a hand-operated control mechanism for controlling both suction and medical gas flow.
In an embodiment the hand-operated control mechanism is a finger activated switch for switching between the source of suction and the source of medical gas, and the control unit may be configured such that when the finger activated mechanism is not activated, medical gas flows to the airway access device, and when activated the medical gas flow is stopped and suction is applied to the airway access device, so that medical gas and suction cannot be provided at the same time.
In an embodiment the hand-operated control mechanism is a finger activated switch for switching between the source of suction and the source of medical gas and the control unit may be configured such that when the finger activated mechanism is not activated, medical gas flows to the airway access device, and when activated the medical gas flow is reduced to a preselected flow rate and suction is simultaneously applied to the airway access device, so that medical gas and suction are provided at the same time.
In an embodiment the airway access device adaptor is connected to, and in flow communication with, the airway access device by means of elongate flexible tubing.
In an embodiment the pressure limiting device is any one of a pressure relief valve, a pressure regulating valve, a rupture disc, an aperture, or a breather vent.
In an embodiment the airway access device is any one of an endotracheal tube, Laryngeal mask airway, tracheostomy tube, nasopharyngeal airway or tube, oropharyngeal tube, cricothyrotomy tube, and the like.
In an embodiment the present disclosure also provides an airway device for delivering medical gas to a patient, comprising:
In an embodiment the hand-operated control mechanism is a finger activated switch for switching between the source of suction and the source of medical gas, the control unit being configured such that when the finger activated mechanism is not activated, medical gas flows to the airway access device, and when activated the medical gas flow is stopped and suction is applied to the airway access device, so that medical gas and suction cannot be provided at the same time.
In an embodiment the hand-operated control mechanism is a finger activated switch for switching between the source of suction and the source of medical gas, the control unit being configured such that when the finger activated mechanism is not activated, medical gas flows to the airway access device, and when activated the medical gas flow is reduced to a preselected flow rate and suction is simultaneously applied to the airway access device, so that medical gas and suction are provided at the same time.
In an embodiment the airway access device adaptor is connected to, and in flow communication with, the airway access device by means of elongate flexible tubing.
In an embodiment the pressure limiting device is any one of a pressure relief valve, a pressure regulating valve, a rupture disc, an aperture, or a breather vent.
In an embodiment the airway access device is any one of an endotracheal tube, Laryngeal mask airway, tracheostomy tube, nasopharyngeal airway or tube, oropharyngeal tube, cricothyrotomy tube, and the like.
In an embodiment the present disclosure provides an airway device for delivering medical gas to a patient, comprising:
In this embodiment the medical gas input control unit further comprises a suction supply coupling located at the first end of the housing and being connectable to a source of suction, the control unit including a hand-operated control mechanism for controlling both suction and medical gas flow.
In this embodiment the pressure limiting device is a pressure relief valve is located adjacent to the second end of the housing with the medical gas supply coupling being located between said pressure relief valve and said suction supply coupling.
In this embodiment the suction supply coupling is located adjacent to the first end of the housing, and wherein the medical gas supply coupling is located adjacent to the second opposed end, and wherein said pressure limiting device is a pressure relief valve located between the medical gas supply coupling and the suction supply coupling.
In summary, the present disclosure provides an airway device for delivering medical gas to a patient and suction, ideally but not exclusively intended for the delivery of apneic oxygenation (or other medical gas), with a pressure relief valve for protection from high pressure. The device includes an intubation stylet and optional medical aspiration directly through an endotracheal patient tube during intubation, without need for a bendable soft catheter. The patient end allows for connection to a standard endotracheal tube connector and the devices includes a self-sealing port at the patient end which allows for the application of an intubation stylet while maintaining airflow with minimal leakage. The patient end of the device and the control unit for controlling medical gas flow and suction are separated by semi-rigid or flexible tubing. The control unit includes a port for the application of standard small bore medical gas tubing that allows for the delivery of apneic oxygenation during insertion of the endotracheal tube into the patient's airway. The control unit includes a pressure release valve that protects the patient airway from high pressures. The control unit further includes a plunger switch that can be engaged by the clinician to provide access medical aspiration directly to the endotracheal tube. The control unit also includes a port that can be connected to standard suction tubing to regulated suction.
It will be understood that while the present device has been described and illustrated as being configured for providing oxygen during the apneic portion of intubation with an endotracheal tube, this device may have other applications. It is essentially a device that allows and controls flow of medical suction and medical gas (that may or may not be oxygen) to an airway device (that may or may not be an endotracheal tube).
The foregoing description of the preferred embodiments of the disclosure has been presented to illustrate the principles of the disclosure and not to limit the disclosure to the particular embodiment illustrated. It is intended that the scope of the disclosure be defined by all of the embodiments encompassed within the following claims and their equivalents.
Number | Date | Country | |
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62489624 | Apr 2017 | US |
Number | Date | Country | |
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Parent | 16608251 | Oct 2019 | US |
Child | 18386749 | US |