The present disclosure relates generally to methods, apparatuses, and systems that assist in the clearing of a patient's airway. More specifically, the present disclosure relates to methods, apparatuses, and systems that assist in aspirating the airway of a patient and where the apparatus is orientation independent and/or has an improved flow path.
Airway injuries, which may result from blunt force and penetrating injuries to the neck and chest, can be life threatening conditions, particularly on a battlefield. The presence of concomitant severe injuries and non-specific symptoms and signs for this type of injury may delay diagnosis and lead to early fatal outcome due to asphyxiation from airway obstruction or death from tension pneumothorax, or late sequela such as airway stenosis and recurrent pulmonary infections.
Airway obstruction and compromise is the second leading cause of preventable battlefield death, which can be attributed to the unavailability of sufficiently powerful portable suction systems, among other factors. Therefore, prompt diagnosis is mandatory for the survival of these patients. However, treatment of these patients is challenging and includes securing a patient airway that will allow adequate ventilation and then repairing the injury with a smaller impact on the respiratory function and the quality of life of the patient.
Portable suction devices available in the market are either manually powered and less efficient, or battery powered and bulky/heavy for combat medics to carry in their kits. Examples of portable suction devices include the Laerdal Compact Suction Unit® 4 (LCSU® 4) by Laerdal Medical; the SSCOR Quickdraw® by SSCOR, Inc.; and the Clario Airway Suction Pump by Medela AG.
The LCSU® 4 includes a collection cannister supported by a wire bracket. The collection cannister can come in a 300 mL size or an 800 mL size container when extra suction volume is needed. The LCSU® 4 weighs between 3.3 to 4.3 pounds depending on the collection cannister size and provides between 50 mmHg to 550 mmHg vacuum pressure for about 45 minutes when powered by batteries. The collection cannister must also be correctly oriented to fit into the wire bracket. An air flow rate of 30 L/min can be obtained with the device. The overall dimensions of the LCSU® 4 are 18.5 cm×26.2 cm×8.12 cm with a 300 mL cannister and 23.6 cm×19 cm×23.6 cm with an 800 mL cannister.
The SSCOR Quickdraw® Tactical requires 10 AAA sized batteries to power the device for 60 to 100 minutes. A maximum negative pressure of >500 mmHg and a low negative pressure setting of 80 mmHg to 100 mmHg can be achieved with the device. The drainable collection cannister can hold a maximum of 300 mL. The collection cannister must also be correctly oriented. The SSCOR Quickdraw® Tactical weighs 2.6 pounds and has overall dimensions of 27 cm×11 cm×11 cm.
The Clario Airway Suction Pump by Medela AG is intended for home health use and can operate for about 50 minutes when powered using the rechargeable battery. A low vacuum setting of 135 mmHg, a medium vacuum setting of 270 mmHg, and a maximum vacuum setting of 600 mmHg can be achieved with the device. The collection cannister can hold a maximum of 550 mL and must also be correctly oriented during operation. A fluid flow rate of 15 L/min can be obtained with the device. The Clario Airway Suction Pump weighs about 2.0 kilograms and has overall dimensions of 22.3 cm×25.5 cm×9.5 cm. Market assessments and surveys conducted by the inventors have demonstrated that combat medics require a lightweight, compact, efficient, and reliable portable suction alternative for the battlefield because combat medics are required to carry everything on their backs. Similarly, civilian EMS providers need a lightweight, reliable, and effective means of clearing debris such as saliva and vomitus from the airway of critical patients. Thus, portability, effectiveness, and ruggedness are key attributes for an airway suction device.
Current designs fall short on many aspects because they were developed using poor/outdated technology. The designs are typically heavy, bulky, provide inadequate suction, and have a short battery life. This results in unnecessary patient suffering and can lead to death from suffocation due to inadequate aspiration of debris or the inability to gain control of the patient's airway in a timely manner.
In view of the foregoing, it is apparent that there exists a need for a device and method to clear airways of patients that overcomes, mitigates, or solves the above problems in the art. Embodiments described herein fulfill this and other needs in the art, which will become apparent to the skilled artisan once given the following disclosure.
This disclosure includes implementations of methods and configurations of apparatuses and systems for aspirating the airway of a patient that address the deficiencies of the devices described above. Non-limiting examples of conditions that benefit from this disclosure include, but are not limited to, tracheobronchial injuries, asphyxiation from airway obstruction, and tension pneumothorax. Certain embodiments are directed to an apparatus for aspirating an airway of a patient, the apparatus comprising a pump portion operatively coupled to a cannister portion. The device being configured to be orientation independent, which is defined by the ability to remain operable when the orientation of the device is changed, that is the device is designed to remain operable when rotated in the x, y, and/or z plane. The pump portion can include one or more pressure sensor, controller, pump, and/or memory. The controller can be in communication with the pressure sensor. The controller can include a processor and a memory. A power source, e.g., a battery, can be in communication with the controller and optionally included in the pump or cannister portion. The cannister portion can include or house a liquid collection cannister (“cannister” or “low-pressure area”). The cannister portion or the liquid collection cannister can have a first or proximal end coupled to the pump portion. In other embodiments the cannister can be coupled to the pump portion or pump assembly at both ends. In certain aspects there may be two pump portions or pump assemblies at both ends of the cannister.
Certain embodiments are directed to a liquid collection cannister comprising a first end and a second end connected by a body wall forming a cannister lumen for receiving fluid during use, the body wall having one or more inlets configured to be coupled with one or more aspiration tubes, at least one of the first end or second end having at least two hydrophobic filters coupled to one or more vacuum inlet, the hydrophobic filters being configured to retain liquid in the cannister and allow gas to be removed from the cannister during use. Further embodiments are directed to a liquid collection cannister comprising a first end and a second end connected by a body wall forming a cannister for receiving and retaining fluid during use, the body wall having one or more inlets configured to be coupled with one or more aspiration tubes. The first end having a hydrophobic filter assembly comprising at least one hydrophobic filter and the second end having a hydrophobic filter assembly having at least one hydrophobic filter, the hydrophobic filters are configured to retain liquid in the cannister and allow gas to be removed from the cannister during use. In certain aspects the cannister is a cylinder. The cannister can have a length of 3 cm to 100 cm and a radius of 0.5 cm to 50 cm. In certain aspects the first end and second end can have at least two hydrophobic filters each. The at least two hydrophobic filters can be positioned on opposite sides of the interior face of the first end and/or second end. The hydrophobic filters can be configured as vacuum conduits connecting the vacuum source to the cannister to provide vacuum to an aspiration tube. The hydrophobic filters can be paper filters. In other aspects the hydrophobic filters comprise a paper filter on a mesh support. The hydrophobic filters can be two-dimensional disks or three-dimensional hollow filters, the three-dimensional hollow filters forming vacuum conduits. The three-dimensional hollow filters can project from the first end and the second end into the cannister and are operably coupled to the vacuum source forming vacuum conduits. The cannister can further comprise an aspiration coupling for attaching an aspiration tube or the like. The cannister can further comprise an aspiration tube coupled to the cannister via the aspiration coupling. The aspiration tube can have a suction tip. In certain aspects, filter(s) can be position at one or both ends of the cannister to provide suction during changes in orientation.
The controller can be configured to measure a pressure at the inlet and shut off the pump when the measured pressure falls below a threshold pressure. The apparatus of any embodiment described herein can further include a light source coupled to or integrated into the handle, the pump portion, cannister portion or any combination thereof. In certain aspects, the apparatus of any embodiment described herein can further include an outer cover configured to be coupled to the pump portion or cannister portion and enclose that portion. The interior walls of the liquid collection cannister can be modified or coated, for example the interior wall of the cannister can be coated, completely or partially with super absorbent polymers, pH reagents, and/or oxygen-sensitive luminescent materials that will assist with demobilizing fluid contents located inside for evacuation from device and assist with content characterization. Certain embodiments can include design elements that provide for characterization of fluid content, these elements include but are not limited to (i) a separate sample chamber couple to the cannister, either upstream or downstream with respect to the cannister; (ii) sensors that measure metrics that help identify fluid sources, such as pH or blood oxygenation, this allows for determination if accumulated fluids include arterial blood (indicating a dangerous hemorrhage), vomit, or other components that may dictate clinical response; (iii) a multi-lumen tubing can be utilized to provide a conduit for wiring, etc. and/or (iv) a “periscope-like” orifice in the housing located over the cannister for assisted viewing of cannister content.
In certain aspects, multi lumen tubing can be included as a suction catheter equipped with additional features without becoming large and bulky, the features include, but are not limited to (i) fiber optic cables inserted through a small channel of the tubing—eliminating the need for an LED, switch, and a battery to be embedded into the catheter; and/or (ii) electrical controls and/or connections for the operation of the suction tip, this may also allow for small data lines to be passed through the small channel to transmit information to a CPU within the pump housing.
A centrifugal pump or diaphragm pump can be configured to generate a vacuum pressure of at least or about 400, 500, 600, to 700 mmHg, including all values and ranges there between. The controller can be configured to evacuate water, vomitus, solid pieces, solid particulates, and/or blood at a flow rate of at least or about 0.5, 0.75, 1.0, 1.25, 1.5, 2.0, 3.0, 4.0, 5.0 to 10 L/min, including all values and ranges there between. The liquid collection cannister can have a storage volume of at least 0.2, 0.5, 1.0, 1.5, 2.0 L to 3.0 L. The processor can be configured to determine patient condition via optical and/or electrochemical analysis. The pump portion, liquid collection cannister, and/or outer cover includes a surface coating with one or more characteristics including one or more of an anti-reflective, a camouflage, an electromagnetic shielding, or combinations thereof. The apparatus of any embodiment described herein can further include a muffler system coupled to the main body to reduce operating noise. The controller can be configured to provide a pressure range for treating pneumothorax (e.g., 5 to 20 mmHg).
Certain embodiments are directed to methods for aspirating an airway of a patient, the method comprising: (a) providing any one of the apparatuses described herein; (b) inserting the suction tube into the airway of the patient; (c) aspirating a fluid from the airway using any one of the apparatuses described herein. The method can further include (e) detecting a patient condition via optical and/or electrochemical analysis using any one of the apparatuses described herein.
The term “coupled” is defined as connected, although not necessarily directly, and not necessarily mechanically; two items that are “coupled” may be unitary with each other.
The terms “a” and “an” are defined as one or more unless this disclosure explicitly requires otherwise.
The term “substantially” is defined as largely but not necessarily wholly what is specified (and includes what is specified, e.g., substantially 90 degrees includes 90 degrees and substantially parallel includes parallel), as understood by a person of ordinary skill in the art. In any configuration or implementation of the present devices, apparatuses, kits, and methods, the term “substantially” may be substituted with “within [a percentage] of” what is specified, where the percentage includes 0.1, 1, 5, and/or 10 percent.
The terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as “has” and “having”), “include” (and any form of include, such as “includes” and “including”) and “contain” (and any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, an apparatus, device, or kit that “comprises,” “has,” “includes” or “contains” one or more elements possesses those one or more elements but is not limited to possessing only those elements. Likewise, a method that “comprises,” “has,” “includes” or “contains” one or more steps possesses those one or more steps but is not limited to possessing only those one or more steps.
Further, an apparatus, device, or structure that is configured in a certain way is configured in at least that way, but it can also be configured in other ways than those specifically described.
Any configuration or implementation of any of the present devices, apparatuses, kits, and methods can consist of or consist essentially of—rather than comprise/include/contain/have—any of the described steps, elements, and/or features. Thus, in any of the claims, the term “consisting of” or “consisting essentially of” can be substituted for any of the open-ended linking verbs recited above, in order to change the scope of a given claim from what it would otherwise be using the open-ended linking verb.
Details associated with the configurations described above and others are presented below.
The following drawings illustrate by way of example and not limitation. For the sake of brevity and clarity, every feature of a given structure is not always labeled in every figure in which that structure appears. Identical reference numbers do not necessarily indicate an identical structure. Rather, the same reference number may be used to indicate a similar feature or a feature with similar functionality, as may non-identical reference numbers. The figures are drawn to scale (unless otherwise noted), meaning the sizes of the depicted elements are accurate relative to each other for at least the configurations depicted in the figures.
Certain embodiments are directed to a lock and pop design, see
Referring to
In some configurations, a controller is configured to measure a pressure at the inlet and shut off the pump when the measured pressure falls below a threshold pressure. In some configurations, the controller is configured to evacuate water, vomitus, solid pieces, solid particulates, and/or blood at a flow rate of at least 0.5 L/min. In some configurations, the controller is configured to provide a pressure range for treating pneumothorax. In some configurations, the processor is configured to determine a patient condition via optical and/or electrochemical analysis.
In some configurations, the aspiration device outer surface includes a surface coating selected from the group of surface coating characteristics consisting of anti-reflective, camouflage, electromagnetic shielding, and combinations thereof. In some configurations, a muffler system can be operatively coupled to the aspiration device to reduce operating noise.
In some configurations, the aspiration device has an overall dimension of 5, 10, 20, 30, 40, 50, 60, 70, 80, 90 to 100 cm×2, 5, 10, 15, 20, 25, 30, 35, 40, 45, to 50 cm×2, 5, 10, 15, 20, 25, 30, 35, 40, 45, to 50 cm or less. In some configurations, the aspiration device has an overall weight of at least, at most, or about 0.25, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, to 10 kg, including all values and ranges there between. In certain aspects the aspiration device has an overall weight of 0.25 to 2 kg. In other aspects the aspiration device has an overall weight of 2 to 7.5 kg.
In some implementations, a method for aspirating an airway of a patient includes (a) providing an aspiration device described herein; (b) inserting the suction tube into the airway of the patient; (c) aspirating a fluid from the airway using an aspiration device described herein. In some implementations, the method further includes detecting a condition in a patient via optical and/or electrochemical analysis of a fluid or liquid collected or during collection using an aspiration device described herein.
Hydrophobic Filters.
Hydrophobicity in the context of this text is to be understood as the tendency of the filtering media to adsorb little or no water. Whereas a hydrophilic filtering media exhibits an affinity for water and readily adsorbs water, a hydrophobic filtering material has the opposite response to water interaction compared to hydrophilic materials. Hydrophobic materials have little or no tendency to adsorb water and water tends to bead on their surfaces (i.e. to form discrete droplets). Hydrophobic materials generally possess low surface tension values and lack active groups in their surface chemistry for formation of “hydrogen-bonds” with water. Water or other aqueous solutions hence generally may not pass the hydrophobic structure of the filtering media, such that water or other aqueous solutions and also debris particles or the like are blocked by the filter such that air or another gaseous flow is filtered. the filter material 144 can be made of a hydrophobic or hydrophilic material or can be coated with a hydrophobic or hydrophilic material for selective filtering.
The above specification and examples provide a complete description of the structure and use of exemplary configurations. Although certain configurations have been described above with a certain degree of particularity, or with reference to one or more individual configurations, those skilled in the art could make numerous alterations to the disclosed configurations without departing from the scope of this invention. As such, the various illustrative configurations of the present devices, apparatuses, kits, and methods are not intended to be limited to the particular forms disclosed. Rather, they include all modifications and alternatives falling within the scope of the claims, and configurations other than the one shown may include some or all of the features of the depicted configuration. For example, components may be combined as a unitary structure, and/or connections may be substituted. Further, where appropriate, aspects of any of the examples described above may be combined with aspects of any of the other examples described to form further examples having comparable or different properties and addressing the same or different problems. Similarly, it will be understood that the benefits and advantages described above may relate to one configuration or may relate to several configurations.
The claims are not intended to include, and should not be interpreted to include, means-plus- or step-plus-function limitations, unless such a limitation is explicitly recited in a given claim using the phrase(s) “means for” or “step for,” respectively.
The following references, to the extent that they provide exemplary procedural or other details supplementary to those set forth herein, are specifically incorporated herein by reference.
This application claims priority to U.S. Provisional Patent Application No. 63/424,063 filed Nov. 9, 2022. The entire contents of the above-referenced disclosure is incorporated herein by reference in its entirety.
Number | Date | Country | |
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63424063 | Nov 2022 | US |