Patent Application
20250222221
Accidental tracheostomy dislodgement (decannulation) is the leading cause of death in pediatric patients. Decannulations usually happen when the tracheostomy tube tie is too loose or, otherwise, when the patient coughs or pulls and/or tugs on the tracheostomy tube. Since many pediatric patients with tracheostomy tubes are non-verbal, it is very difficult for the patient to alert a caregiver when a decannulation occurs, especially if the caregiver and the patient are not in the same room. This is further exacerbated because the end of the tracheostomy tube that passes through the stoma may remain hidden from view of the caregiver even during decannulation. When the tracheostomy tube becomes dislodged, the stoma may close before the decannulation of the tracheostomy tube has been noticed, which can lead to asphyxiation of the patient. If the decannulation is noticed before the stoma fully closes, it may be possible for the caregiver to insert the same or, often, a smaller diameter tracheostomy tube to keep the airway open to prevent asphyxiation of the patient until the patient can be transported to a medical site, such as a hospital, for assistance in replacing the smaller tracheostomy tube with the original tracheostomy tube. Given this unmet need and the dire consequences associated with unnoticed decannulation of a tracheostomy tube, a tracheostomy decannulation detection device that can alert caregivers when a decannulation event is occurring or about to occur is urgently needed. When a caregiver is provided with sufficient notice of a decannulation event or an impending event, this would allow an adequate response time for taking remediative actions. Such a decannulation detection device will allow the caregiver to reinsert the tracheostomy tube before the stoma closes or reposition the tracheostomy to prevent total decannulation, decreasing the incidence of death by asphyxiation for pediatric patients with tracheostomy tubes.
According to an example embodiment a decannulation detection system is provided herein, the decannulation detection system comprising: a dressing for application over a wound or incision site, the dressing comprising a first electric circuit portion; a tube assembly for positioning in contact with the dressing, the tube assembly comprising a second electric circuit portion; and a controller; wherein, when the tube assembly is in contact with the dressing, the first and second electrical circuit portions form a complete electric circuit; wherein the controller is electrically connected to the complete electric circuit and is configured to monitor electrical continuity in the complete electric circuit; and wherein, when the controller detects an electrical discontinuity in the complete electric circuit, the controller is configured to trigger an alert regarding a possible occurrence of a decannulation event.
In some embodiments of the decannulation detection system, at least a portion of the tube assembly extends at least partially within a wound or incision at the wound or incision site.
In some embodiments of the decannulation detection system, the wound or incision comprises a stoma and the tube assembly comprises a tracheostomy tube assembly.
In some embodiments of the decannulation detection system, the first electrical circuit portion comprises a plurality of discontinuous wires, or foil sheets that are formed in or on an outer surface of the dressing, the outer surface being opposite a surface of the dressing that is against the skin of a patient in which the wound or incision site is formed; the tube assembly comprises a center portion and flanges, the flanges extending from opposite sides of the center portion; the second electrical circuit portion comprises, formed in each of the flanges, at least one electrical contact that protrudes through a surface of a corresponding one of the flanges when the tube assembly contacts the dressing; and when the tube assembly is in contact with the dressing, each of the one or more electrical contacts form an electrical connection between different ones of the plurality of discontinuous wires or foil sheets to form the complete electric circuit.
In some embodiments of the decannulation detection system, the one or more electrical contacts comprise spring-loaded pins.
In some embodiments of the decannulation detection system, when the tube assembly moves away from the dressing during the decannulation event, at least one of the one or more electrical contacts are separated from the dressing to cause the electrical discontinuity in the complete electrical circuit.
In some embodiments of the decannulation detection system, each flange comprises a plurality of electrical contacts spaced apart from each other in an anticipated direction of movement or rotation of the tube assembly away from the dressing during the decannulation event.
In some embodiments of the decannulation detection system, the complete electric circuit is formed only when the tube assembly is in direct contact with the dressing.
According to another example embodiment, a method for detecting a decannulation event is provided, the method comprising: providing a controller; applying a dressing over a wound or incision site, the dressing comprising a first electric circuit portion; positioning a tube assembly adjacent to the dressing, the tube assembly comprising a second electric circuit portion, wherein, when the tube assembly is in contact with the dressing, the first and second electric circuit portions form a complete electric circuit; connecting the controller to the complete electric circuit; monitoring, using the controller, electrical continuity in the complete electric circuit; and triggering, via the controller, an alert regarding a possible occurrence of the decannulation event when the controller detects the electrical discontinuity in the complete electric circuit.
In some embodiments of the method, at least a portion of the tube assembly extends at least partially within a wound or incision at the wound or incision site.
In some embodiments of the method, the wound or incision comprises a stoma and the tube assembly comprises a tracheostomy tube assembly.
In some embodiments of the method, the electrical discontinuity in the complete electric circuit occurs only when the tube assembly has moved at least a predetermined distance away from the dressing, the predetermined distance being correlated with the possible occurrence of the decannulation event.
In some embodiments of the method: the first electrical circuit portion comprises a plurality of discontinuous wires, or foil sheets that are formed in or on an outer surface of the dressing, the outer surface being opposite a surface of the dressing that is against the skin of a patient in which the wound or incision site is formed; the tube assembly comprises a center portion and flanges, the flanges extending from opposite sides of the center portion; the second electrical circuit portion comprises, formed in each of the flanges, at least one electrical contact that protrudes through a surface of a corresponding one of the flanges when the tube assembly contacts the dressing; and when the tube assembly is in contact with the dressing, each of the one or more electrical contacts form an electrical connection between different ones of the plurality of discontinuous wires or foil sheets to form the complete electric circuit.
In some embodiments of the method, the one or more electrical contacts comprise spring-loaded pins.
In some embodiments of the method, when the tube assembly moves away from the dressing during the decannulation event, at least one of the one or more electrical contacts are separated from the dressing to cause the electrical discontinuity in the complete electrical circuit.
In some embodiments of the method, each flange comprises a plurality of electrical contacts spaced apart from each other in an anticipated direction of movement or rotation of the tube assembly away from the dressing during the decannulation event
In some embodiments of the method, the complete electric circuit is formed only when the tube assembly is in direct contact with the dressing.
According to another example embodiment, a decannulation detection system is provided, the decannulation detection device comprising: a tube assembly for positioning in contact with a dressing applied over a wound or incision site or over skin at the wound or incision site, wherein the tube assembly at least partially extends within a wound or incision at the wound or incision site and comprises one or more light sensors; and a controller; wherein the one or more light sensors are positioned on the tube assembly such that light can only be received by the one or more light sensors from a side of the tube assembly that is positioned against the dressing or skin at the wound or incision site; wherein the tube assembly is configured such that, when pressed against the dressing or the skin, no ambient light from outside the tube assembly can be received by the one or more light sensors; wherein, during a decannulation event, the tube assembly is shifted away from the dressing or skin, so as to allow the ambient light to be received by the one or more light sensors; and wherein, when any of the one or more light sensors detects light above a predetermined threshold corresponding to the decannulation event, the controller is configured to trigger an alert regarding a possible occurrence of a decannulation event.
In some embodiments of the decannulation detection system, the wound or incision comprises a stoma and the tube assembly comprises a tracheostomy tube assembly.
In some embodiments of the decannulation detection system, the tube assembly comprises a center portion and flanges, the flanges extending from opposite sides of the center portion; each flange comprises a cavity with a slot formed therein, the slot being formed to extend from the cavity through a surface of the flange that contacts the dressing or the skin; the one or more light sensors comprises a plurality of light sensors, each of the plurality of light sensors being attached to one of the flanges; a photosensor of each light sensor is aligned with the slot of the flange to which such light sensor is attached; and the flanges of the tube assembly comprise a deformable material configured to conform to the surface of the dressing or the skin to block the ambient light from the photosensor of the light sensor when the tube assembly is pressed against the dressing or the skin.
In some embodiments of the decannulation detection system, the deformable material comprises silicone.
In some embodiments of the decannulation detection system, when the tube assembly moves away from the dressing during the decannulation event, one or more of the flanges are separated from the dressing or the skin to allow the ambient light to be incident on the photosensor of a corresponding one of the light sensors.
In some embodiments, the decannulation detection system comprises a light emitter configured to emit a designated wavelength of light, wherein, during the decannulation event, the light sensor is configured to receive light from the light emitter to cause the controller to issue the alert regarding the occurrence of the decannulation event.
In some embodiments of the decannulation detection system, the decannulation detection system is configured to detect the decannulation event in an environment in which no ambient light is present.
In some embodiments of the decannulation detection system, the tube assembly is in direct contact with the dressing or the skin.
According to another example embodiment, a method for detecting a decannulation event is provided, the method comprising: providing a controller; attaching one or more light sensors on the tube assembly; positioning the tube assembly in contact with a dressing applied over a wound or incision site or over skin at the wound or incision site, wherein the tube assembly at least partially extends within a wound or incision at the wound or incision site and comprises one or more light sensors, wherein: the one or more light sensors are positioned on the tube assembly such that light can only be received by the one or more light sensors from a side of the tube assembly that is positioned against the dressing or skin at the wound or incision site; when pressed against the dressing or the skin, no ambient light from outside the tube assembly can be received by the one or more light sensors due to the tube assembly being pressed against the dressing or the skin; and during a decannulation event, the tube assembly is shifted away from the dressing or skin, so as to allow the ambient light to be received by the one or more light sensors; the method further comprising detecting, using the one or more light sensors, light; and triggering, via the controller, an alert regarding a possible occurrence of the decannulation event when any of the one or more light sensors detects light above a predetermined threshold corresponding to the decannulation event.
In some embodiments of the method, the wound or incision comprises a stoma and the tube assembly comprises a tracheostomy tube assembly.
In some embodiments of the method, light is detected by the one or more light sensors only when the tube assembly has moved at least a predetermined distance away from the dressing, the predetermined distance being correlated with the possible occurrence of the decannulation event.
In some embodiments of the method: the tube assembly comprises a center portion and flanges, the flanges extending from opposite sides of the center portion; each flange comprises a cavity with a slot formed therein, the slot being formed to extend from the cavity through a surface of the flange that contacts the dressing or the skin; the one or more light sensors comprises a plurality of light sensors, each of the plurality of light sensors being attached to one of the flanges; a photosensor of each light sensor is aligned with the slot of the flange to which such light sensor is attached; and the flanges of the tube assembly comprise a deformable material configured to conform to the surface of the dressing or the skin to block the ambient light from the photosensor of the light sensor when the tube assembly is pressed against the dressing or the skin.
In some embodiments of the method, the deformable material comprises silicone.
In some embodiments of the method, when the tube assembly moves away from the dressing during the decannulation event, one or more of the flanges are separated from the dressing or the skin to allow the ambient light to be incident on the photosensor of a corresponding one of the light sensors.
In some embodiments, the method comprises emitting, from a light emitter, light having a designated wavelength, wherein, during the decannulation event, the light sensor receives the light having the designated wavelength from the light emitter to cause the controller to issue the alert regarding the occurrence of the decannulation event.
In some embodiments of the method, the decannulation detection system can detect the decannulation event in an environment in which no ambient light is present.
In some embodiments of the method, the tube assembly is in direct contact with the dressing or the skin.
According to another example embodiment, a decannulation detection system is provided, the decannulation detection device comprising: a dressing for application over a wound or incision site, the dressing comprising one or more first capacitive plates; a tube assembly for positioning in contact with the dressing and comprising one or more second capacitive plates; an electrical circuit that is connected to the one or more first capacitive plates and the one or more second capacitive plates; and a controller that is configured to detect and monitor a capacitance between the one or more first capacitive plates and the one or more second capacitive plates, wherein the capacitance varies based on a distance between the one or more first capacitive plates and the one or more second capacitive plates; wherein, when the controller detects that the capacitance between the one or more first capacitive plates and the one or more second capacitive plates is not within a predetermined range of capacitance values or is above or below a threshold capacitance value, the controller is configured to trigger an alert regarding a possible occurrence of a decannulation event.
In some embodiments of the decannulation detection system, at least a portion of the tube assembly extends at least partially within a wound or incision at the wound or incision site.
In some embodiments of the decannulation detection system, the wound or incision comprises a stoma and the tube assembly comprises a tracheostomy tube assembly.
In some embodiments, the decannulation detection system comprises an insulator positioned directly between each of one or more first capacitive plates and/or the one or more second capacitive plates to prevent direct contact between one or more first capacitive plates and the one or more second capacitive plates.
In some embodiments of the decannulation detection system, when the tube assembly moves away from the dressing during the decannulation event, the one or more first capacitive plates and the one or more second capacitive plates are moved away from each other by a corresponding distance, which causes a change in the capacitance measured between the one or more first capacitive plates and the one or more second capacitive plates.
In some embodiments of the decannulation detection system, the tube assembly comprises a center portion and flanges, the flanges extending from opposite sides of the center portion.
In some embodiments of the decannulation detection system, each flange comprises at least one of the one or more first capacitive plates, such that the tube assembly comprises a plurality of first capacitive plates and the dressing comprises a same quantity of the one or more second capacitive plates as a total quantity of plurality of first capacitive plates.
According to another example embodiment, a method for detecting a decannulation event is provided, the method comprising: applying a dressing over a wound or incision site, the dressing comprising one or more first capacitive plates; positioning the tube assembly in contact with the dressing, the tube assembly comprising one or more second capacitive plates; providing an electrical circuit that is connected to the one or more first capacitive plates and the one or more second capacitive plates; detecting, using a controller, a capacitance between the one or more first capacitive plates and the one or more second capacitive plates, wherein the capacitance varies based on a distance between the one or more first capacitive plates and the one or more second capacitive plates; monitoring the capacitance; and triggering, using the controller, an alert regarding a possible occurrence of the decannulation event when the controller detects that the capacitance between the one or more first capacitive plates and the one or more second capacitive plates is not within a predetermined range of capacitance values or is above or below a threshold capacitance value.
In some embodiments of the method, at least a portion of the tube assembly extends at least partially within a wound or incision at the wound or incision site.
In some embodiments of the method, the wound or incision comprises a stoma and the tube assembly comprises a tracheostomy tube assembly.
In some embodiments, the method comprises positioning an insulator directly between each of one or more first capacitive plates and/or the one or more second capacitive plates to prevent direct contact between one or more first capacitive plates and the one or more second capacitive plates.
In some embodiments of the method, when the tube assembly moves away from the dressing during the decannulation event, the one or more first capacitive plates and the one or more second capacitive plates are moved away from each other by a corresponding distance, which causes a change in the capacitance measured between the one or more first capacitive plates and the one or more second capacitive plates.
In some embodiments of the method, the tube assembly comprises a center portion and flanges, the flanges extending from opposite sides of the center portion.
In some embodiments of the method, each flange comprises at least one of the one or more first capacitive plates, such that the tube assembly comprises a plurality of first capacitive plates and the dressing comprises a same quantity of the one or more second capacitive plates as a total quantity of plurality of first capacitive plates.
According to another example embodiment, a decannulation detection system is provided, the decannulation detection device comprising: a dressing for application over a wound or incision site, the dressing comprising one or more first inductors; a tube assembly for positioning in contact with the dressing and comprising one or more second inductors; and an electric circuit that is connected to the one or more first inductors and the one or more second inductors; and a controller that is configured to detect and monitor an inductance, optionally a mutual inductance, between the one or more first inductors and the one or more second inductors, wherein the inductance varies based on a distance between the one or more first inductors and the one or more second inductors; wherein, when the controller detects that the inductance between the one or more first inductors and the one or more second inductors is not within a predetermined range of inductance values or is above or below a threshold inductance value, the controller is configured to trigger an alert regarding a possible occurrence of a decannulation event.
In some embodiments of the decannulation detection system, at least a portion of the tube assembly extends at least partially within a wound or incision at the wound or incision site.
In some embodiments of the decannulation detection system, the wound or incision comprises a stoma and the tube assembly comprises a tracheostomy tube assembly.
In some embodiments of the decannulation detection system, the one or more first inductors each comprise coils of a wire in the electric circuit; and/or the one or more second inductors each comprise coils of a wire in the electric circuit.
In some embodiments of the decannulation detection system, when the tube assembly moves away from the dressing during the decannulation event, the one or more first inductors and the one or more second inductors are moved away from each other by a corresponding distance, which causes a change in the inductance measured between the one or more first inductors and the one or more second inductors.
In some embodiments of the decannulation detection system, the tube assembly comprises a center portion and flanges, the flanges extending from opposite sides of the center portion.
In some embodiments of the decannulation detection system, each flange comprises at least one of the one or more first inductors, such that the tube assembly comprises a plurality of first inductors and the dressing comprises a same quantity of the one or more second inductors as a total quantity of plurality of first inductors.
According to another example embodiment, a method for detecting a decannulation event is provided, the method comprising: applying a dressing over a wound or incision site, the dressing comprising one or more first inductors; positioning the tube assembly in contact with the dressing, the tube assembly comprising one or more second inductors; providing an electric circuit that is connected to the one or more first inductors and the one or more second inductors; detecting, using a controller, an inductance, optionally a mutual inductance, between the one or more first inductors and the one or more second inductors, wherein the inductance varies based on a distance between the one or more first inductors and the one or more second inductors; monitoring the inductance; and triggering, using the controller, an alert regarding a possible occurrence of the decannulation event when the controller detects that the inductance between the one or more first inductors and the one or more second inductors is not within a predetermined range of inductance values or is above or below a threshold inductance value.
In some embodiments of the method, at least a portion of the tube assembly extends at least partially within a wound or incision at the wound or incision site.
In some embodiments of the method, the wound or incision comprises a stoma and the tube assembly comprises a tracheostomy tube assembly.
In some embodiments of the method, the one or more first inductors each comprise coils of a wire in the electric circuit; and/or the one or more second inductors each comprise coils of a wire in the electric circuit.
In some embodiments of the method, when the tube assembly moves away from the dressing during the decannulation event, the one or more first inductors and the one or more second inductors are moved away from each other by a corresponding distance, which causes a change in the inductance measured between the one or more first inductors and the one or more second inductors.
In some embodiments of the method, the tube assembly comprises a center portion and flanges, the flanges extending from opposite sides of the center portion.
In some embodiments of the method, each flange comprises at least one of the one or more first inductors, such that the tube assembly comprises a plurality of first inductors and the dressing comprises a same quantity of the one or more second inductors as a total quantity of plurality of first inductors.
The presently disclosed subject matter now will be described more fully hereinafter, in which some, but not all embodiments of the presently disclosed subject matter are described. Indeed, the presently disclosed subject matter can be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements.
To meet the aforementioned challenges and requirements, disclosed herein are example systems and methods for using a tracheostomy tube assembly to detect the occurrence of a movement of a tube assembly (e.g., a tracheostomy tube assembly, but not being limited thereto) to and/or beyond a predetermined amount, or degree, of movement. Movement of the tube assembly to and/or beyond the predetermined amount of movement is indicative of the occurrence of a decannulation event, in which the tracheostomy tube is removed fully or partially from the stoma, that may otherwise go unnoticed in a sufficient amount of time for a caregiver to take remediative actions.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood to one having ordinary skill in the art to which the presently disclosed subject matter belongs. Although any methods, devices, and materials similar or equivalent to those described herein can be used in the practice or testing of the presently disclosed subject matter, representative methods, devices, and materials are now described.
Following long-standing patent law convention, the terms “a”, “an”, and “the” refer to “one or more” when used in this application, including the claims. Thus, for example, reference to “a capacitive plate” can include a plurality of such capacitive plates, and so forth.
Unless otherwise indicated, all numbers expressing quantities of length, diameter, width, and so forth used in the specification and claims are to be understood as being modified in all instances by the terms “about” or “approximately”. Accordingly, unless indicated to the contrary, the numerical parameters set forth in this specification and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by the presently disclosed subject matter.
As used herein, the terms “about” and “approximately,” when referring to a value or to a length, width, diameter, temperature, time, volume, concentration, percentage, etc., is meant to encompass variations of in some embodiments ±20%, in some embodiments ±10%, in some embodiments ±5%, in some embodiments ±1%, in some embodiments ±0.5%, and in some embodiments ±0.1% from the specified amount, as such variations are appropriate for the disclosed apparatuses and devices.
The term “comprising”, which is synonymous with “including” “containing” or “characterized by” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. “Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements can be added and still form a construct within the scope of the claim.
As used herein, the phrase “consisting of” excludes any element, step, or ingredient not specified in the claim. When the phrase “consists of” appears in a clause of the body of a claim, rather than immediately following the preamble, it limits only the element set forth in that clause; other elements are not excluded from the claim as a whole. As used herein, the phrase “consisting essentially of” limits the scope of a claim to the specified materials or steps, plus those that do not materially affect the basic and novel characteristic(s) of the claimed subject matter.
With respect to the terms “comprising”, “consisting of”, and “consisting essentially of”, where one of these three terms is used herein, the presently disclosed and claimed subject matter can include the use of either of the other two terms.
As used herein, the term “and/or” when used in the context of a listing of entities, refers to the entities being present singly or in combination. Thus, for example, the phrase “A, B, C, and/or D” includes A, B, C, and D individually, but also includes any and all combinations and sub-combinations of A, B, C, and D.
The term “subject”, “individual”, and “patient” are used interchangeably herein, and refer to an animal, especially a mammal, for example a human, to whom treatment or monitoring, with a device or system as described herein, is provided. The term “mammal” is intended to encompass a singular “mammal” and plural “mammals,” and includes, but is not limited: to humans, primates such as apes, monkeys, orangutans, and chimpanzees; canids such as dogs and wolves; felids such as cats, lions, and tigers; equids such as horses, donkeys, and zebras, food animals such as cows, pigs, and sheep; ungulates such as deer and giraffes; rodents such as mice, rats, hamsters and guinea pigs; and bears.
As shown in
As shown in
Each flange 118 comprises a tie hole (e.g., 90, see
The electrical contact 130 in the form of a spring-loaded pin provides the ability to accommodate varying anatomy and small movement (e.g., breathing, etc.) without resulting in false alerts for the occurrence of a decannulation event. If the tracheostomy tube 116 becomes partially or completely dislodged, the spring pin electrical contact 130 will break contact with (e.g., become electrically discontinuous with) the metallic material of the dressing and the detection circuit (e.g., 140, see
As shown in
An alternate embodiment of a tracheostomy tube assembly, generally designated 102, which is configured to detect a decannulation event via monitoring electrical continuity, is shown in
Further configurations of suitable electric circuits in addition to those shown in
A decannulation detection system that is based on light detection can use an active light source, such as an LED, and/or can rely on ambient light.
In either embodiment, a light sensor 400 is provided to monitor for the presence or absence of light that is incident upon the light sensor 400. When the amount (e.g., intensity) of light incident on the light sensor 400 exceeds a predetermined threshold that has been determined to be correlated to the possible occurrence of a partial or complete decannulation event, the decannulation detection system is configured to trigger an alert to notify caregivers of the possible occurrence of a decannulation event. As shown, the tracheostomy tube assembly 103 may be configured to have mounted thereto a plurality of light sensors 400. These light sensors 400 can be configured to operate substantially identically to each other or different from each other, such that one or both light sensors 400 could be active, one or both light sensors 400 could be passive, or one light sensor 400 could be active and the other light sensor 400 could be passive.
In embodiments in which one or more light sensors 400 are configured as an active light-detection sensor, the decannulation detection system can use one or more active light sources, or light emitters. The light emitters can be configured to emit light having a designated wavelength of light that corresponds to a wavelength of light that the photosensor 442 is configured to detect. This designated wavelength of light can be a wavelength outside of the visible light spectrum and, in some instances, can be a wavelength of light that is not found in ambient light on Earth. One or more such light emitters can be paired with a corresponding one or more of the light sensors 400, so as to advantageously improve the performance of such light-detection sensors 400 having an active configuration. Thus, each light sensor 400 can have associated therewith one or more light emitters. The use of one or more active light source for each light sensor 400 provides a more robust light-detection method, as filters and/or wavelength selection can be used (e.g., by a controller and/or by the light sensor 400 itself) to reduce the probability of false positives or false negatives. The use of an active light source provides the additional safeguard for operation of the decannulation detection system in low-light environments (e.g. nighttime, dark room, or for instances where clothing may be worn by the patient that might block ambient light from reaching the photosensor even during a decannulation event).
As shown in
In order for such a known tracheostomy tube holder to be used as part of a decannulation detection system, a light sensor housing 300 is attached (e.g., in a press-fit, or interference fit, manner, or via any other suitably rigid attachment type) by insertion through one of the tie holes formed through the flange 118, thereby forming a quasi-extension of the flange 118. Aspects of the light sensor housing 300 are further illustrated in
As shown in
In some embodiments, the flanges 118 and/or the light sensor housings 300 comprise a deformable material (e.g., silicone or similar suitable material) that is configured to conform to the surface of the dressing 10 or to the skin of the patient (e.g., in instances in which the tracheostomy tube holder 103 may be used in a configuration in which the light sensors 400 are positioned to extend beyond the perimeter of the dressing 10, this deformable aspect allowing for ambient light to be blocked from being incident upon the photosensor 442 of the light sensor 400 when the tracheostomy tube assembly 103 is pressed against the dressing or the skin.
The dressing 10 has a first capacitive plate 20 on an outer surface thereof (e.g., the surface that is opposite the surface by which the dressing 10 is attached, for example, adhesively, to the skin of the patient about the incision or wound site). The second capacitive plate 120 is attached to the rear surface of the central portion 112 and flanges 118, the rear surface being the surface that is opposite to the surface to which the raised portion 114 is attached to the central portion 112 and also the surface that will be adjacent to (e.g., closest to) the dressing 10 when the tracheostomy tube 116 is inserted through the incision or wound site (e.g., stoma). Thus, when the tracheostomy tube 116 is inserted within the stoma, the first and second capacitive plates 20, 120 are positioned adjacent to each other (e.g., positioned within a distance from each other to measure a change in capacitance therebetween due to relative movement between the first and second capacitive plates 20, 120, for example, towards/away from each other).
According to this example embodiment, the relative position between the first capacitive plate 20 attached to the dressing 10 and the second capacitive plate 120 attached to the tracheostomy tube assembly 104 can be determined by measuring one or more capacitance values between the first and second capacitive plates 20, 120 to detect the occurrence of a decannulation event (e.g., in realtime). In some embodiments, the first and second capacitive plates 20, 120 can each be subdivided into a plurality of capacitive plates, such that a plurality of first capacitive plates 20 are provided on the dressing 10 and a plurality of second capacitive plates 120 are provided on the tracheostomy tube assembly 104. Each of the first capacitive plates 20 is positioned on the dressing 10 such that, when the tracheostomy tube assembly 104 is positioned over the dressing 10, each such first capacitive plate 20 will be positioned adjacent to a corresponding one of the second capacitive plates, such that each of the first capacitive plates 20 forms a capacitive plate pair with one of the second capacitive plates 120, thereby allowing for capacitance to be measured between such capacitive plate pairs to advantageously detect a partial or full decannulation event that may not be recognized when using a single first capacitive plate 20 and a single second capacitive plate 120. The capacitive plate pairs may be arranged in any pattern and/or position without limitation.
In the example embodiments shown in
As the position of the second capacitive plate 120 on the tracheostomy tube assembly 104 changes relative to the first capacitive plate 20 on the dressing 10, accumulated charge varies, or is modified, this change in cumulative charge being used to infer a position of the tracheostomy tube assembly 104 relative to the dressing 10. The detection of capacitance may be intermittently monitored or continuously monitored. As shown in
The dressing 10 has a first inductor 22 on an outer surface thereof (e.g., the surface that is opposite the surface by which the dressing 10 is attached, for example, adhesively, to the skin of the patient about the incision or wound site). This first inductor 22 can be, for example, in the form of an inductance source, such as a plurality of flattened coils in the form of an electromagnet. The first inductor 22 is shown being concentrically arranged about the hole 16 in the dressing 10 through which the tracheostomy tube 116 is inserted for insertion through the wound and/or incision site (e.g., into the stoma). However, the first inductor 22 is not limited to the position, size, and/or shape shown in
In the example embodiment shown, the first and second inductors 22, 122 are flattened coils formed out of wire. The first or second inductors 22, 122 can be continuously or intermittently provided with an electric current through an electrical circuit connected thereto. The electric current provided to the first and/or second inductors 22, 122 can be variable or constant without limitation. The first and second inductors 22, 122 are substantially coaxially aligned with each other when the tracheostomy tube assembly 105 is positioned against, or adjacent to, the dressing 10, with the tracheostomy tube 116 being inserted within and through the stoma. The electric current flowing through the first and/or second inductors 22, 122 (e.g., whichever is the “active,” or transmitting, inductor) will cause the corresponding first and/or second inductor 22, 112 that receives the electric current to generate a magnetic field that is oriented so as to induce a corresponding voltage and electrical current in the other of the first and/or second inductors 22, 122 (e.g., the “passive,” or receiving, inductor).
Thus, in some instances, the decannulation detection system 1-3 can be configured such that the first inductor 22 is provided with an electrical current and, thus, also considered as the “active” inductor, in which case the first inductor 22 generates a magnetic field that is oriented so as to induce a corresponding voltage and electrical current in the second inductor 122, which is thus considered as the “passive” inductor, in the manner of an inductance sensor. Furthermore, in some other instances, the decannulation detection system 1-3 can be configured such that the second inductor 122 is provided with an electrical current and, thus, also considered as the “active” inductor, in which case the second inductor 122 generates a magnetic field that is oriented so as to induce a corresponding voltage and electrical current in the first inductor 22, which is thus considered as the “passive” inductor, in the manner of an inductance sensor.
Regardless of the configuration and which of the first and second inductors 22, 122 is regarded as the “active” inductor and which is regarded as the “passive” inductor, the current and voltage induced in the “passive” inductor is measured and/or monitored and used to trigger an alert when a change in the voltage and/or current induced in the “passive” inductor is determined to be outside of a predetermined range, or greater than or less than a threshold value associated with the voltage and/or the current. This predetermined range or threshold value for the voltage and/or current is correlated with (e.g., in a calibrated, precise manner) a movement of the tracheostomy tube assembly 104 away from the dressing 10 that has been determined empirically (e.g., during design of the decannulation detection 1-3 for a particular size, configuration, etc.) to be indicative of the possible occurrence and/or initiation of a decannulation event. In some embodiments, a transfer function (e.g., impedance) can be used as a proxy to infer a distance between the tracheostomy tube assembly 105 and the dressing 10.
According to the example embodiment of the decannulation detection system 1-3, the relative position between the first inductor 22 attached to the dressing 10 and the second inductor 122 attached to the tracheostomy tube assembly 105 can be determined by measuring one or more inductance parameters (e.g., of a magnetic field produced by the inductor) to detect the occurrence of a decannulation event (e.g., in realtime).
In some embodiments, a plurality of first inductors 22 can be provided on the dressing 10 and a plurality of second inductors 122 can be provided on the tracheostomy tube assembly 105 and arranged, with respect to each other, to form inductor pairs, in which the first and second inductors 22, 122 of each such inductor pair are substantially coaxial with each other when the tracheostomy tube assembly 105 is in an installed position, against or adjacent to the dressing 10. These inductor pairs can thus be provided at a plurality of different positions on the tracheostomy tube assembly 105 and dressing 10, respectively, such that inductance between the first and second inductors 22, 122 can be measured between each of the inductor pairs to advantageously more readily detect a partial or full decannulation event than may be possible using a single first inductor 22 and a single second inductor 22. While one or more of the first and second inductors 22, 122 of the respective pluralities thereof can be provided around (e.g., coaxial with) the hole 16, in embodiments of the decannulation detection system 1-3 in which such inductor pairs are provided, it is possible in some configurations for none of the inductor pairs to be positioned around the hole 16, whether coaxially arranged or otherwise; instead, in some instances, all of the inductor pairs may be spaced apart from the hole 16, such that none of the inductor pairs is arranged coincident or around any of the hole 16, of any portion thereof. The inductor pairs may be arranged in any pattern and/or position without limitation. In some embodiments having a plurality of first inductors 22 and a plurality of second inductors 122, in some of the inductor pairs the first inductor 22 thereof may be the “active” inductor and the second inductor 122 thereof may be the “passive” or sensing inductor and, in the other inductor pairs, the first inductor 22 thereof may be the “passive” or sensing inductor and the second inductor 122 thereof may be the “active” inductor.
In some embodiments, the decannulation detection system 1-3 can comprise N (e.g., a plurality) of each of the first and second inductors 22, 122, in the manner of inductor pairs described elsewhere herein. These inductor pairs can be, for example, in the form of respective pairs of concentric coils of electrically conductive material. As the position of the second inductor 122 on the tracheostomy tube assembly 105 changes relative to the first inductor 22 on the dressing 10, a change in inductance (e.g., mutual inductance) is detected. This change in inductance is then used to infer a position of the tracheostomy tube assembly 105 relative to the dressing 10. The detection of inductance may be intermittently monitored or continuously monitored. As shown in
Each of the example embodiments of the decannulation detection systems and/or tracheostomy tube assemblies disclosed herein is suitable for use in detecting dislodgement of a tracheostomy tube from a wound or incision cite before a full decannulation event has occurred.
Each of the example embodiments of the decannulation detection systems and/or tracheostomy tube assemblies disclosed herein is able to adapt to various types of conventional pediatric tracheostomy tubes.
Each of the example embodiments of the decannulation detection systems and/or tracheostomy tube assemblies disclosed herein is low-profile, meaning that each of the respective tracheostomy tube assemblies is not prevented from sitting flush against the patient's neck dressing 10 and/or skin.
Each of the example embodiments of the decannulation detection systems and/or tracheostomy tube assemblies disclosed herein is suitable for use in a home healthcare setting.
Each of the example embodiments of the decannulation detection systems and/or tracheostomy tube assemblies disclosed herein have been evaluated to demonstrate the ability to detect partial and/or complete decannulation of a tracheostomy tube. Ambient light detection (e.g., in the manner of tracheostomy tube holder 103) has been determined to have high sensitivity, along with a correspondingly higher potential for false positives, while the use of a spring pin (e.g., in the manner of tracheostomy tube assemblies 101, 102) and detection of electrical continuity has slightly less sensitivity and is a binary signal.
In each of the example embodiments of the decannulation detection systems and/or tracheostomy tube assemblies disclosed herein, the sensor housings (e.g., 200, 300) sit flush with the surface of the flange 118 of the tracheostomy tube assembly (e.g., 101, 103).
Each of the example embodiments of the decannulation detection systems and/or tracheostomy tube assemblies disclosed herein is configured to detect when the flange 118 of the tracheostomy tube assembly 100-105 is no longer flush with the dressing 10. In some embodiments, the decannulation detection systems disclosed herein are configured to distinguish between displacement of a sensor on any or all of the flanges of the tracheostomy tube assembly.
In each of the example embodiments of the decannulation detection systems and/or tracheostomy tube assemblies disclosed herein, the tracheostomy tube assemblies are able to be fastened with conventional tracheostomy collar fastening methods (e.g., hook-and-loop collar, etc.).
While the decannulation detection systems described in the example embodiments disclosed herein pertain to decannulation of a tracheostomy tube, such decannulation detection systems are not limited to such applications. To the contrary, such decannulation detection systems can be applied to detect decannulation of any tube, wire, etc. inserted through an orifice or incision formed in the body of a patient (e.g., a human, but also including other animals) for which unintended removal thereof would advantageously be guarded against or prevented and/or would benefit from early warning of possible partial and/or complete decannulation thereof.
While the term “tracheostomy tube assembly” is used to illustrate an example application of the decannulation detection systems disclosed herein, such decannulation detection systems are not limited to tracheostomy tube applications. In fact, the decannulation detection systems disclosed herein can be used to detect decannulation of essentially any—ostomy tube from a wound or incision site without limitation.
The description herein describes embodiments of the presently disclosed subject matter, and in some cases notes variations and permutations of such embodiments. This description is merely exemplary of the numerous and varied embodiments. The description or mentioning of one or more representative features of a given embodiment is likewise exemplary. Such an embodiment can typically exist with or without the feature(s) mentioned; likewise, all of the features disclosed in each of the example embodiments can be applied to any of the other example embodiments disclosed herein without limitation and without regard to whether the combination of such features is expressly described herein, unless a preclusion against the combination of such features is expressly noted herein.
It will be understood that various details of the presently disclosed subject matter may be changed without departing from the scope of the presently disclosed subject matter. Furthermore, the foregoing description of the example embodiments disclosed herein is only provided for the purpose of illustration only and is not to be used to limit in any way the scope of the subject matter disclosed herein.
This application claims priority to U.S. Provisional Patent Application Ser. No. 63/297,974, filed on Jan. 10, 2022, the disclosure of which is incorporated herein by reference in its entirety.
This invention was made with government support under Grant No. TR002489 awarded by the National Institutes of Health. The government has certain rights in the invention.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2023/010487 | 1/10/2023 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63297974 | Jan 2022 | US |
