Patent Application
20230381439
The present invention relates generally to human and veterinary medical devices. Specifically, the present invention relates to an airway stabilization system designed to maintain an airway device in a preselected position in the trachea of a human patient or an animal and for preventing clinically significant movement thereof and unintentional extubation of the patient or animal in response to the application of significant multidirectional forces to the airway device. More specifically, the system of the present invention relates to an adjustable airway securement device or Interlock collar and stabilization system that enables precise, safe and effective positioning of airway devices or endotracheal tube apparatus (ETT) of different lengths and diameters adapted to fit the airways of patients having oral and tracheal anatomical structures and facial geometries of various sizes.
Endotracheal intubation is a medical procedure used to place an airway device (artificial airway) into a patient's trachea or airway. The use of an airway device is mandated in situations where an individual, or an animal in veterinary applications, is unable to independently sustain the natural breathing function or maintain an open airway due to unconsciousness, trauma, disease, drugs or anesthesia. Thus, life-saving mechanical ventilation is provided through the airway device, which may be in the form of an endotracheal tube (ETT), or a supraglottic airway device such as a laryngeal mask airway (LMA), King Airway, or one of several other commercially available airway devices.
Endotracheal intubation is accomplished by inserting an airway device into the mouth, down through the throat and larynx, and into the trachea. This procedure creates an artificial passageway through which air can freely and continuously flow in and out of a patient's lungs and prevents the patient's airway from collapsing or occluding.
It is very important that the airway device be positioned correctly and maintained in the correct position in the trachea. If the device moves out of its proper position in the trachea and into either the right or left main stem bronchial tube, only one lung will be ventilated. Failure to ventilate the other lung can lead to a host of severe pulmonary complications. Moreover, if the airway device moves completely out of the trachea and into the pharynx, esophagus or completely outside the body, the patient will become hypoxic due to the lack of ventilation to the lungs, a condition which typically results in life-threatening brain injury and death within a matter of only a few minutes.
Even after an airway device has been positioned correctly, subsequent movement of the patient can lead to inadvertent movement of the device, as hereinabove described. An intubated patient may restlessly move about and, on his or her own, may also attempt to forcibly remove an airway device, whether conscious or subconscious, particularly if the patient is uncomfortable or having difficulty breathing, which can lead to panic. In the case of an animal patient, agitation may be particularly pronounced due to the animal's lack of cognitive awareness or understanding of its circumstances and an instinctual survival fight or flight response. A large animal or a carnivore can pose a serious danger not only to itself but also to a treating veterinarian and anyone in close proximity under such circumstances.
Medical emergencies may occur anywhere. Accordingly, emergency medical service personal (i.e., paramedics) may be called upon to insert airway devices in out-of-hospital emergency settings, for example at accident scenes, and military personnel in combat situations, in emergency response vehicles, as well as in hospital settings by emergency department physicians, anesthesiologists, and critical care clinicians. Therefore, such unintentional movement of either the patient or an airway device is not uncommon, particularly when the patient is moved from an out-of-hospital setting, such as any one of the afore-mentioned scenarios, to an emergency department of a hospital. Further, anytime an intubated patient is be moved, for example, not only from an ambulance to a trauma facility, but also from one hospital to another hospital, from one area of the hospital to another area in the same hospital (imaging, laboratory, operating theater), or from a hospital to an outpatient rehabilitation facility, unintentional movement of an airway device is a risk. Even repositioning an intubated patient in a hospital bed, or in the case of an animal, in a recovery cage, may cause unintentional movement of the endotracheal tube.
Inadvertent movement of an airway device may also occur as a result of moving external ventilation equipment, such as a conventional mechanical ventilator or bag valve mask. Typically, the external ventilation equipment is connected to the external end of the device by an air conduit to establish air flow to and from the lungs. Inadvertent pulling on, or other excessive movement of the air conduit, may not only disconnect it from the airway device, but may also transfer movement to the airway device, thereby shifting it from its proper position and causing unplanned extubation.
Unplanned extubation is a hazardous and costly problem in humans, a problem which studies have established occurs at an unacceptably high rate. For example, Statistics published by the Society for Critical Care Medicine states that in 2017 there were 1.65 Million intubated, mechanically ventilated ICU patients in the United States (Medicine, S.f.C.C. Critical Care Statistics 2017). A review of the world-wide medical literature suggests that the world-wide rate of unplanned extubation averages approximately 7.31% of extubated patients. Lucas de Silva, Unplanned Endotracheal Extubation in the Intensive Care Unit: Systematic Review, Critical Appraisal, and Evidence-Based Recommendations. Anesth Analg 2012; 114:1003-14. Applying the world-wide average to the U.S. figure above, an estimated 120,000 patients in the United States alone experience an unplanned extubation each year. Such incidents of unplanned extubation are costly, not only for patients who experience increased rates of morbidity and mortality, but also for hospitals, physicians and insurance companies who incur the liability costs associated therewith. The annual intensive care unit (ICU) bed cost associated with unplanned extubations in the United States alone is estimated at $4.9 Billion, which includes imaging, pharmacy, and laboratory expenses. (Extrapolated using data from the Carson study referenced above and the cost of long-term care according to the U.S. Department of Health and Human Services National Clearinghouse for long-term care information. See also S. K. Epstein, M. L. Nevins & J. Chung, Effect of Unplanned Extubation on Outcome of Mechanical Ventilation, Am. Journal of Respiratory and Critical Care Medicine, 161: 1912-1916 (2000) which discusses the increased likelihood of long-term care outcome). Moreover, it is not unknown for jury damage awards in personal injury lawsuits arising from unplanned extubations to be in excess of $35 M.
Clearly, the economic losses related to unintentional extubation of animals are not as serious as the well-documented economic losses in human cases. Nonetheless, economic losses in the agricultural sector of valuable farm animals, breeding stock, and food resources, particularly in underdeveloped countries, cannot be ignored. On the domestic side, as anyone who has lost a beloved pet can attest, the emotional pain can equal that experienced at the loss of a family member. In view of the foregoing, the high incidence of unplanned extubation and the associated increase in healthcare costs implies that an improved restraining system is sorely needed, a system which has the capacity to resist the application of forces which would otherwise result in movement of the airway device.
Various prior art systems have attempted to address the problem of maintaining an airway device in the correct position and preventing unintentional extubation. The most common approach for securing an airway device (typically, an endotracheal tube/ETT) is with adhesive tape, which is applied to the patient's upper lip and then around the smooth outside surface of the ETT. Umbilical tape can also be used to secure the airway device and is tied around the patient's neck and then around the ETT. Both tapes are typically anchored to the corner of the patient's mouth; however, they may be anchored to the center of the mouth, as well. Both present the same challenges. Arranged in this fashion, the tape is intended to anchor the endotracheal tube and prevent its unintentional movement. While the use of tape in this manner provides some benefit, the restraint available from the tape usually diminishes because the tape becomes covered and/or saturated with blood, saliva, or other bodily fluids. Consequently, the endotracheal tube may be readily moved from its preferred position in a patient's trachea. In spite of its widespread use, adhesive or surgical tape is woefully inadequate in providing protection against movement resulting from the application of multidirectional forces such as bending, torsional/rotational or substantial lateral forces to the device, forces which may exceed fifty (50) pounds in magnitude.
The results of two studies of the restraint capabilities of current devices and methods are set forth in Tables 1, 2 and 3 below. Such devices and methods do not provide sufficient resistance to prevent unplanned extubation. Clinically significant movement is defined as longitudinal movement of the airway device in a direction away from the patient's mouth to a point where the tip of the airway device has moved beyond the larynx or vocal cords. Typically, such movement in a human patient is in the range of five (5) to seven (7) centimeters. In an animal, it may be significantly more or less, depending upon the size of the animal. For example, clinically significant movement in a cat is considerably less than clinically significant movement in a long-necked animal such as a horse or a giraffe.
Frequently, to maintain an effective restraint, attending medical personnel increase the amount of clamping force applied on an airway device. Increasing the amount of clamping force to an effective level may pinch the device to the point where a portion of the inner tube diameter (and hence air passageway) is significantly restricted. Restricting the cross-sectional size of the air passageway decreases the ventilatory efficiency of the tube, thereby decreasing the respiratory airflow and increasing the work associated with the breathing process. The restriction of the cross-sectional size of the air passageway creates resistance to both inspiratory airflow and expiratory airflow. Insufficient airflow during inspiration can lead to hypoxemia, which is problematic, but can be overcome by increasing the positive pressure of the ventilation source. However, during expiration, any increased pressure due to constriction or decreased tube diameter, increases the amount of work a patient must perform to simply exhale. Increased pressure can also lead to barotrauma in the lungs and resistance to expiratory airflow can lead to multiple other adverse effects within the lungs. Impairing a patient's ventilation may result in serious medical effects, particularly with patients whose functions are already compromised. Therefore, the ability for clinicians to adequately stabilize an airway device for prevention of unplanned extubation without constriction of the air passageway is crucial for patient safety.
Moreover, issues related to the wide range of ETT tube sizes and patient facial geometries remain unaddressed. Unplanned and accidental extubation of children and neonates is an area of significant concern. Infants and children have unique challenges with endotracheal tube securement, and pediatric patients are at particularly high risk for unplanned extubation due to anatomic and physiologic factors. Unplanned extubations in newborns and pediatric patients are unfortunately common, potentially devastating and costly, often leading to the same life-threatening cardiovascular and respiratory complications experienced by adults, such as hypoxia, hypercarbia, airway trauma, ventilator associated pneumonia, intraventricular hemorrhage, and death. Intubation systems presently available for mechanical ventilation of more fully developed children and adult patients are simply unsuitable for intubation of young children and infants. An improved pediatric securement system that reduces the rate of unplanned extubation in infants and children is needed which would improve outcomes for these categories of patients.
In view of the foregoing, it will be apparent to those skilled in the art from this disclosure that a need exists for an adjustable airway securement device or Interlock collar that may be affixed to any airway device and a stabilization system which cooperates with the Interlock collar/airway device unit to not only protect an airway device from occlusion and crushing, but which also facilitates application thereof to a patient. The stabilization system secures the Interlock collar/airway device unit to the patient, maintains the airway device in its preferred position in a patient's trachea, and prevents clinically significant movement thereof with respect to the vocal cords as a result of the application of multidirectional forces of significant magnitude thereto. Specific needs exist to address the variations which may be encountered in effective positioning of any commercially available airway device or endotracheal tube apparatus (ETT) having a diameter and a length selected to fit properly in an airway of patients having anatomical and facial geometries of various sizes and to address the unique challenges associated with maintaining the mechanical ventilation of infants and children. The present invention addresses these needs in the art as well as other needs, all of which will become apparent to those skilled in the art from the accompanying disclosure.
In order to address the aforementioned needs in the art, an adjustable airway stabilization system including a securing apparatus or stabilizer and an adjustable securement device or Interlock collar is provided which is adapted to stabilize and secure any airway device, aftermarket or otherwise, that may be used with human patients or with animal patients in veterinary applications regardless of size to maintain an airway in a human or animal patient's trachea. The securing apparatus or stabilizer and the Interlock collar cooperate with one another to prevent clinically significant movement of the airway device with respect to a patient's vocal cords in response to the application of forces in any direction to the device, be they longitudinal, torsional/rotational or bending.
The airway device has a flexible elongate body which is installed in a patients trachea. The airway device includes a continuous sidewall having outer and inner surfaces extending intermediate a proximal and a distal end portion thereof circumferentially about and longitudinally parallel to a central axis, thereby forming a hollow conduit through which the airway is established.
In an embodiment, a securing apparatus or stabilizer portion of an adjustable airway stabilization system includes a frame, bridge or support member secured to the patient and a tower structure or clamshell-type clamping member operatively connected thereto. The clamping member is configured to interact in clamping engagement with the continuous sidewall of the airway device via the adjustable Interlock collar selectively positioned in the tower structure to prevent clinically significant movement of the distal end of the airway device with respect to the vocal cords of the patient. The bridge or support member is of unitary construction to allow greater ease of application, the bridge member being structured and arranged to be secured over the face of a patient and operatively connected to the clamping member while, at the same time, providing ease of access to the patient's oral cavity for administration of medications and oral hygiene.
The tower structure or clamping member is adjustably secured to the frame or support member and extends outwardly therefrom along a longitudinal axis which extends coaxially with the longitudinal axis of the airway device in a direction away from a patient's face. The clamping member includes a pair of oppositely disposed pivotally interconnected c-shaped collars or clamshells, each collar or clamshell having a first end and a second end and a body portion extending therebetween, the body portion having an inner surface and an outer surface, the inner surface of at least one of the body portions including a plurality of substantially uniformly spaced-apart annular flanges positioned axially along the inner surface of the body portion and extending substantially inwardly therefrom, and a plurality of structural recesses positioned axially along the inner surface of the body portion intermediate an adjacent two of the plurality of substantially uniformly spaced-apart annular flanges the ribs and structural recesses of the clamshells.
In an embodiment, the adjustable Interlock collar includes a pair of pivotally interconnected elongate c-shaped cylindrical members, each positioned within and operatively connected in clamping engagement to a respective one of the c-shaped collars or clamshells of the tower structure and extending outwardly from the patient's face coaxially with the longitudinal axis of the tower structure or clamping member. Each of the elongate cylindrical members includes first and second ends and a body portion having an inner surface and an outer surface extending therebetween. The outer surface of at least one cylindrical member includes at least one annular flange and structural recess extending radially outwardly from the outer surface and adapted to operatively interact with one of the plurality of structural recesses formed intermediate the substantially uniformly spaced-apart annular flanges positioned axially along the inner surface of each of the clamshells to retain the airway device in a preselected position in a patient's airway.
In an embodiment, the inner surface of the Interlock collar may be coated with an adhesive or friction-based material layer, by way of example and not of limitation, a pressure sensitive adhesive (PSA) adapted to adhesively engage the outer surface of an airway device.
In yet another embodiment, the inner surface of the Interlock collar may be textured, for example, like the surface texturing found on a porcupine quill, minute suction structures, or micro texture surface technologies such as a Sharklet® micropattern to selectively prevent axial motion of an airway device along its longitudinal axis in one or both axial directions.
In still another embodiment, the Interlock collar includes a mechanism for selectively deploying a bonding agent intermediate the inner surface of at least one of the pair of pivotally interconnected elongate c-shaped cylindrical members and the outer surface of the continuous sidewall of an airway device.
In yet another embodiment, the bonding agent comprises cyclohexanone.
In another embodiment, at least one of the c-shaped cylindrical members of the Interlock collar includes a vertical flex beam member adapted to releasably engage airway devices having different diameters.
In still another embodiment, at least one of the c-shaped cylindrical members of the Interlock collar includes one or more radial flex beam members adapted to releasably engage airway devices having different diameters.
In yet another embodiment, at least one of the c-shaped cylindrical members of the Interlock collar includes a linear wave spring adapted to releasably engage airway devices having different diameters.
In another embodiment, at least one of the c-shaped cylindrical members of the Interlock collar includes a compression spring adapted to releasably engage airway devices having different diameters.
In an embodiment, the adjustable airway securement device or Interlock collar includes a latch mechanism adapted to secure the Interlock collar in a selected position on an airway device.
In another embodiment, the adjustable airway securement device or Interlock collar includes a cam cleat lock mechanism adapted to secure the Interlock collar in a preselected position on an airway device.
In another embodiment, the adjustable airway securement device or Interlock collar includes an internal flexure structure lock mechanism adapted to secure the Interlock collar in a preselected position on an airway device.
In another embodiment, the adjustable airway securement device or Interlock collar includes a c-clamp and adjustable belt or strap lock mechanism adapted to secure the Interlock collar in a preselected position on an airway device.
In yet another embodiment, the airway stabilization system includes a lateral position adjustment mechanism adapted to laterally adjust the position of the tower structure on the bridge or support member.
In an embodiment, the adjustable airway stabilization system tower structure includes a locking mechanism adapted to releasably lock the pivotally interconnected clamshells together circumferentially around the Interlock collar in stabilizing and supporting engagement therewith.
In another embodiment the airway stabilization system/tower structure locking mechanism further includes a release mechanism, for example, a quick-release actuator or button whereby the c-shaped collars or clamshells may be easily and rapidly released from locking engagement with one another.
In still another embodiment, the Interlock collar is adapted to be secured to a patient by tape, twill, and/or thread.
These and other features, aspects and advantages of the present invention will become apparent to those skilled in the art from the following detailed description of preferred embodiments taken in connection with the accompanying drawings, which are briefly summarized below, and by reference to the appended claims.
Referring now to the attached drawings which form a part of this original disclosure:
Selected embodiments of the present invention will now be explained with reference to the drawings. It will be apparent to those skilled in the art from this disclosure that the following descriptions of the embodiments of the present invention are provided for illustration only and not for the purpose of limiting the invention as defined by the appended claims and their equivalents.
Referring initially to
As will be described in greater detail below, Interlock collar secured to the airway device is adapted to maintain an air passageway to a patient's lungs via the patient's mouth, oral cavity, throat, past a patient's vocal cords or larynx into a patient's trachea, the trachea having a length and forming an airway in the patient, and to a patient's carina (the point where the trachea bifurcates into a left and a right bronchial tube) for respiration of the patient. By way of example and not of limitation, the airway device may be in the form of an endotracheal tube (ETT) as shown in the accompanying figures, one of several commercially available endotracheal tubes or one of several commercially available supraglottic airway devices such as a King LT™ airway device manufactured by King Systems, Noblesville, Indiana or a laryngeal mask airway (LMA) such as a LMA Classic™ manufactured by LMA North America, San Diego, California.
Referring to
As shown in
Referring again to
The tower structure or clamping member includes a pair of oppositely disposed pivotally interconnected c-shaped collars or clamshell clamping members, more specifically, a tower clamshell clamping member 80 as shown in greater detail in
As best viewed in
The second edge surface 86 extends radially outwardly in a direction perpendicular to the body 81 of the tower clamshell thereby forming an end face 86′ of a housing 110 for containing a release mechanism or release button, as will be described in greater detail below. The end face 86′ has at least one, and in a preferred embodiment shown, two apertures 112 formed therein, each aperture being adapted to releasably receive a respective latch member 625 operatively connected to the door 600 (
Referring now to the second edge surface 88 of the tower clamshell 80 in
The attachment bracket 160 includes a pair of opposing, spaced apart L-shaped channel members 180, 182, each channel member including a vertically extending body or leg member 184, 186 and opposing legs 188, 190 operatively connected thereto or formed integrally therewith, each leg extending perpendicularly from the respective body member to which it is attached in a direction toward the opposing leg. In the embodiment shown, channel member 180 is formed integrally with the second end 150 of the downwardly extending body 147 of the mounting arm 140. However, it is to be understood that the channel member may be a separate structure attached to the second end by suitable fasteners such as bolts, pins or other attachment devices. An attachment member 192 connects the channel member 182 to the mounting arm 147. In the embodiment shown, the attachment member 192 is in the form of a rectangular block or plate having an upper surface 194, a lower surface 196, and a first stepped edge 198 in mating connecting engagement with a corresponding stepped shelf 200 formed in the second end 150. The attachment member or plate 192 also includes a second end 202 having a flange or rib 204 extending downwardly from and transversely across the bottom surface. The flange or rib 204 is in mating connecting engagement with a corresponding stepped shelf 206 formed on an end 208 of vertically extending body or leg member 186. The attachment bracket 160 is structured to attach to a release attachment mechanism illustrated in
Referring now to
The release attachment mechanism is structured and arranged to moveably fit over the linear track 220 and be releasably secured thereto. By way of example and not of limitation, the release mechanism is operated by manually manipulating or squeezing together outwardly biased ears, wings or levers 242 and 244 connected to a first respective end of one of the pair of pinch tab members 235, 237, which flexes each of the second ends 230, 232 apart releasing them from recesses 227. Squeezing the ears or levers and releasing the ends of the pinch tabs allows adjustment of the lateral position of the release attachment mechanism and the securing apparatus or stabilizer 70 operatively connected thereto in the direction of the arrow C-C on a patient in response to the patient's anatomical features.
As best shown in
Referring now to
Referring now to
In the embodiment shown, the elongate c-shaped cylindrical members 300, 400 of the Interlock collar 5 are pivotally interconnected by a collar pin 430 shown in
In the embodiment of
Referring to
The release button 650 further includes a fist end 670 formed integrally with or operatively connected to a side panel 672 via a curved corner section 675. An aperture 678 is formed in the first end section, the aperture having a resilient outwardly biased latch member 680 structured and arranged to be releasably received in locking engagement in aperture 122 formed in the open-ended receptacle 127 of the tower clamshell 81. An opposite or second end 682 is open and includes two rectangularly-shaped apertures 682, 685 separated by a horizontally extending actuating member 687. The apertures 683 and 685 are aligned and cooperate with apertures 112 to receive a respective one of the one or more latch members 624 connected to the door. Both the horizontally extending actuating member 687 and a second horizontally extending actuating member 689 extending parallel thereto along the bottom surface panel 660 have an upper beveled surface 688 and 690 respectively, each beveled surface being adapted to slideably engage a parallel beveled surface 625 formed on each of the one or more latch members 624. The release button is biased by the coil spring 665 and the outwardly biased latch member into the latched position. When pressure is applied manually to the scalloped top surface 657, the horizontally extending actuating members are lowered, thus permitting withdrawal of the latch members from the apertures and opening of the clamshells. The top scalloped portion of the release button is recessed slightly within the open-ended receptacle to prevent accidental depression of the release button and release of the latching mechanism, which would allow the door to open inadvertently.
To prevent premature closure and latching of the Interlock collar during shipping, storage, and distribution and to facilitate ease of workflow during application, a packaging wedge indicated at 700 in
The elements of the packing wedge are shown in greater detail in
As best viewed in
Referring now to
The housing 808 includes a generally rectangularly shaped body 812 having an inner side 814, an outer side 816 and a pair of oppositely disposed end members or panels 818, 820 extending therebetween. As shown in
In operation, when generally cylindrically-shaped tower structure or clamshell-type clamping member 72 and the adjustable airway securement device or Interlock collar 5 are closed into securing engagement with the airway device, the second end 454 of the flexible beam member 450 engages the external surface 20 of an airway device body, and, held in place in a closed configuration by latch mechanism 470, the elastomeric energy stored in the flexible beam, either acting alone, or in cooperation with restraining forces which may be provided by adhesive or textured features of the surfaces 312 and 460, prevents unintended movement of airway devices of different sizes in response to the application of multidirectional forces thereto. Moreover, when engaged, releasable latch mechanism 113 maintains the least one annular flange 322 and structural recess 324 extending radially outwardly from the outer surface 314 of cylindrical member 300 in operative engagement with one of the plurality of structural recesses 100 formed intermediate the substantially uniformly spaced-apart annular flanges 98 positioned axially along the inner surface 90 of clamping member clamshell 80. This novel feature permits rapid engagement and disengagement of the clamping member clamshell and the Interlock collar whereby the position of an airway device in a patient's trachea may be quickly and accurately adjusted along axis B-B in response to a patient's anatomy and situational events arising during treatment requiring rapid response. By way of further example and not of limitation, one or more of the ribs on the cylindrical members 300 may be omitted, thereby providing a surface or slot for receiving securing tape, twine or string.
While only selected embodiments have been chosen to illustrate the present invention, it will be apparent to those skilled in the art from this disclosure that various changes and modifications can be made herein without departing from the scope of the invention as defined in the appended claims. Furthermore, the foregoing descriptions of the embodiments according to the present invention are provided for illustration only, and not for the purpose of limiting the invention as defined by the appended claims and their equivalents.
This application claims priority to U.S. Provisional Patent Application Ser. No. 63/108,274 filed on Oct. 30, 2020, the entire contents of which are incorporated herein by reference.
This invention was made with Government support under Contract No. FA8629-20-C-5014 awarded by the United States Air Force. The Government has certain rights in the invention.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US21/57464 | 10/29/2021 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63108274 | Oct 2020 | US |
