Tracheostomy trainer and method of use

Abstract

A tracheostomy trainer includes a head pivotally connected to a neck and a chest, he head, neck and chest define an interior space, and the neck defines a tracheostomy opening. The trainer further includes a tube entrance coupled to a mouth, an upper airway tube fluidly coupling a chest tube to the tube entrance, the upper airway tube residing at least partially in the head and at least partially in the neck, and the chest tube fluidly coupling the upper airway tube to a lung bag. The chest tube resides at least partially within the chest, and the lung bag resides within the chest. At least one of the upper airway tube or the chest tube defines a trach tube opening, the trach tube opening aligning with the tracheostomy opening, the upper airway tube, the chest tube, and the lung bag comprising an air tight fluid path, wherein fluid enters and exits the air tight fluid path via the mouth and the trach tube opening.

Description

TRACHEOSTOMY TRAINER AND METHOD OF USECROSS REFERENCES TO RELATED APPLICATIONS

[0001] The following application claims priority under 35 U.S.C. § 119 (e) to U.S. Provisional Patent Application Serial No. 63 / 543,178 filed October 9, 2023 entitled TRACHEOSTOMY TRAINER AND METHOD OF USE. The above-identified application is incorporated herein by reference in its entirety for all purposes.TECHNICAL FIELD

[0002] The present disclosure generally relates to a tracheostomy task trainer and method of use, and more particularly to a tracheostomy task trainer and method of use for training a wide variety of end users, including training for in-home and emergency care of tracheostomy patients.BACKGROUND

[0003] Tracheostomies require maintenance tasks, including tracheostomy (trach) suctioning, tracheostomy site cleaning, changing of trach ties, and routine trach changes. These routine skills are used on a frequent basis, and if performed well, reduce the probability of emergency situations. Beyond routine maintenance tasks, a trach patient may require emergency interventions such as an emergent trach change, managing an airway when the trach cannot be reinserted in a stoma, rescue breathing with a resuscitator bag, and cardiopulmonary resuscitation (CPR). As part of routine care, patients, non-medical, and medical professionals will inspect the stoma of the tracheostomy tube for signs of infection,including redness, warmth, and mucus. Currently, there are no tracheostomy trainers available for a wide variety of end-users (e.g., healthcare staff, healthcare programs, caregivers, community providers). Tracheostomy tubes can become blocked, inhibiting breathing and / or requiring cardiopulmonary resuscitation (CPR). There are currently no comprehensive commercially available emergency tracheostomy task trainers with or without CPR training options.SUMMARY

[0004] One aspect of the present disclosure comprises a tracheostomy task trainer comprising a head defining a mouth, the head pivotably connected to a neck and chest, the head, neck and chest defining an interior space, the neck defining a tracheostomy opening, a tube entrance coupled to a mouth, an upper airway tube fluidly coupling a chest tube to the tube entrance, the upper airway tube residing at least partially in the head and at least partially in the neck, and the chest tube fluidly coupling the upper airway tube to the lung bag, the chest tube residing at least partially within the chest, and the lung bag residing within the chest, the upper airway tube, the chest tube, and the lung bag comprising an air tight fluid path, at least one of the upper airway tube or the chest tube defining a trach tube opening, the upper airway tube, the chest tube, and the lung bag comprising an air tight fluid path, wherein fluid enters and exits the air tight fluid path via the mouth and the trach tube opening,

[0005] Another aspect of the present disclosure comprises a method of using a tracheostomy task trainer. The method inciudes positioning a head of the tracheostomy task trainer into a trach position, the head pivotably connected to a neck, the head, neck and chest defining an interior space, the head defining a mouth, wherein a tube entrance is coupled to the mouth, the interior space housing an upper airw'ay tube fluidly coupling a chest tube to the tube entrance, the neck defining a tracheostomy opening, the upper airway tube defining atrach tube opening, the chest tube coupled to a lung bag housed within the chest, wherein the trach position allows air flow from the mouth and / or nose to the lung bag. The method further includes inserting a tracheostomy tube into the tracheostomy opening with the trach tube opening and removing the tracheostomy tube from the tracheostomy opening with the trach lube opening.

[0006] Yet another aspect of the present disclosure comprises tracheostomy task trainer. The tracheostomy task trainer includes a head defining a mouth, the head pivotably connected to a neck and chest, the head, neck and chest defining an interior space, the neck defining a tracheostomy opening, and a tube entrance coupled to the mouth, an upper airway tube fluidly coupling a chest tube to the tube entrance. The upper airway tube resides at least partially in the head and at least partially in the neck, and the chest tube fluidly couples the upper airway tube to a lung bag, The chest tube resides at least partially within the chest, and the lung bag resides within the chest, and at least one of the upper airway tube or the chest tube defining a trach tube opening. The upper airway tube, the chest tube, and the lung bag form an air tight fluid path, wherein fluid enters and exits the air tight fluid path via at least one of the mouth and the trach tube opening.BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The foregoing and other features and advantages of the present disclosure will become apparent to one skilled in the art to which the present disclosure relates upon consideration of the following description of the disclosure with reference to the accompanying drawings, wherein like reference numerals, unless otherwise described refer to like parts throughout the drawings and in which:

[0008] FIG. 1 illustrates a tracheostomy task trainer, in accordance with one exampleembodiment of the present disclosure;

[0009] FIG. 2 illustrates a portion of a tracheostomy task trainer including a tracheostomy opening, in accordance with one example embodiment of the present disclosure;

[0010] FIG. 3 illustrates interior structures of a tracheostomy task trainer, in accordance with one example embodiment of the present disclosure;[0011 [ FIG. 4 illustrates interior structures of a tracheostomy task trainer, in accordance with one example em bodiment of the present disclosure;

[0012] FIG. 5 illustrates internal portions of a tracheostomy task trainer including a tracheostomy opening, in accordance with one example embodiment of the present disclosure;

[0013] FIG. 6 illustrates internal portions of a tracheostomy task trainer, in accordance with one example embodiment of the present disclosure:

[0014] FIG. 7 illustrates a support structure of a tracheostomy task trainer, in accordance with one example embodiment of the present disclosure;

[0015] FIG. 8 illustrates an internal portion of a chest portion of a tracheostomy task trainer, in accordance with one example embodiment of the present disclosure;

[0016] FIG. 9 illustrates a partially deconstructed tracheostomy task trainer, in accordance with one example embodiment of the present disclosure;

[0017] FIG. 10 illustrates a back of a tracheostomy task trainer, in accordance with one example embodiment of the present disclosure;

[0018] FIG. 11 illustrates a tracheostomy task trainer housing a tracheostomy tube, in accordance with one example embodiment of the present disclosure;[00.19] FIG. 12 illustrates a method of utilizing a tracheostomy task trainer, in accordance with one example embodiment of the present disclosure.

[0020] Skilled artisans will appreciate that elements in the figures are illustrated for simplicity' and clarity' and have not necessarily been drawn to scale. For example, the dimensions of some of the elements in the figures may be exaggerated relative to other elements to help to improve understanding of embodiments of the present disclosure.

[0021] The apparatus and method components have been represented where appropriate by conventional symbols in the drawings, showing only those specific details that are pertinent to understanding the embodiments of the present disclosure so as not to obscure the disclosure with details that will be readily apparent to those of ordinary skill in the art having the benefit of the description herein.DETAILED DESCRIPTION

[0022] Referring now to the figures generally wherein like numbered features shown therein refer to like elements throughout unless otherwise noted. The present disclosure generally relates to a tracheostomy task trainer and method of use, and more particularly to a tracheostomy task trainer and method of use for training a wide variety of end users, including training for in home and emergency care of tracheostomy patients.

[0023] FIGS 1 -11 illustrate an example embodiment of a tracheostomy task trainer 100, and specifically, FIG. 1 illustrates an example embodiment of the tracheostomy task trainer 100, wherein internal portions are illustrated with dashed lines. In this example embodiment, the tracheostomy task trainer 100 includes a head 102 pivotably connected to a neck 1 10 and chest 114, by a coupler 108. In one example embodiment, the head 102 includes a nose 104, including one or more openings 104a, 104b (e.g., mimicking nostrils), and a mouth 106. In one example embodiment, the head 102, neck 110 and chest 114 are molded as one or more pieces. In anotherexample embodiment, the head 102 is a separate element that is connectable to the neck 110, and the neck and chest 114 are a single piece. In one example embodiment, the head 102, neck 110 and chest 114 define interior spaces wherein interior components 140 reside. In one example embodiment, the head 102, neck 110 and chest 114 are made of a plastic and / or silicone material. As shown in the illustrated example embodiment, the neck 110 defines a tracheostomy opening 112. In one example embodiment, the tracheostomy opening 112 has an opening diameter of between 4.7mm to about 10mm. In another example embodiment, the tracheostomy opening 112 has the opening diameter between about 8mm and about 9mm.

[0024] As shown in the illustrated example embodiment, the tracheostomy task trainer 100 includes interior components 140. The interior components 140 include a tube entrance 150 defining an entrance to an upper airway tube 152, the upper airway tube 152 defining an airtight, space within the head 102 and at least partially into the neck 1 10. In one example embodiment, the coupling of the tube entrance 150 to the mouth 106 is air and / or fluid tight. The interior components 140 further include the upper airway tube 152 coupled to a chest tube 156 by a tube coupler 154. In one example embodiment, the upper airway tube 152 further comprises a rubber material. Herein, fluid includes gases, liquids, and solids that can travel along a fluid path.

[0025] In the illustrated example embodiments, the chest tube 156 defines a trach tube opening 158. In another illustrated example embodiments, the upper airway tube 152 defines the trach tube opening 158. In one example embodiment, the trach tube opening 158 has an opening diameter of between 5mm to about 14mm. In another example embodiment, the trach tube opening 158 has the opening diameter of about 10mm to about 14mm. In another example embodiment, the trach tube opening 158 and the tracheostomy opening 112 are a same or similar size. The combination of the trach tube opening 158 and the tracheostomy opening 112 mimic a stoma in a tracheostomy patient. In one example embodiment, the trach tube opening 158 alignswith the tracheostomy opening 1 12. In another example embodiment, a portion of the chest tube 156 is coupled to an interior portion of the neck 110, such that the trach tube opening 158 aligns with the tracheostomy opening 112. In another example embodiment, the interior components 140 includes a tube support 164. (see FIG. 7). In this example embodiment, a portion of the chest tube 156 is supported by the tube support 164, wherein the tube support is coupled to an interior portion of the neck 110, such that the trach tube opening 158 aligns with the tracheostomy opening 112. In yet another example embodiment, the chest tube 156 is not coupled to an interior portion of the neck 110, wherein, the head 102 must be positioned in a trach position to align the trach tube opening 158 with the tracheostomy opening 112. In one example embodiment, the trach position is wherein the head 102 is tilted away from the neck 110 via a pivot of the coupling 108. In another example embodiment, the trach position is wherein the head 102 is tilted a trach angle 111 from the neck 110, as measured from a bottom surface 102a of the head and a top surface 110a of the neck. In one example embodiment, the trach angle 11 1 is between 70° to about 110°. In another example embodiment, the trach angle 111 is 90°

[0026] In another example embodiment, the interior components 140 include a lung bag 160 coupled to the chest tube 156. In this example embodiment, the tube entrance 150, the upper airway tube 152, the chest tube 156, and the lung bag 160 form an airtight and / or fluid tight system, wherein air and / or fluid exit thought the mouth 106 and / or the trach tube opening 158. In one example embodiment, the upper airway tube 152, the tube coupler 154, the chest tube 156, and / or the lung bag 160 are made of plastic, rubber, and / or another air tight material.

[0027] In the example embodiment of FIG. 1 1 , a tracheostomy tube 170 has an outer cannula 172 that resides within the trachea and an inner cannula 174 which is removed from the outer cannula for cleaning, when secretions are blocking the airway, or the like. In anotherexample, the tracheostomy tube 170 is simple tube with no inner cannula. Utilizing the tracheostomy task trainer 100, a user practices inserting and removing the inner cannula. Further, as illustrated in the example embodiment of FIG. 2, the tracheostomy task trainer 100 includes a mucous module 136. In this example embodiment, the mucous module 136 comprises a viscous material that mimics mucous. The mucous module 136 is insertable into the mouth 106 and / or through the trach tube opening 158 and the tracheostomy opening 112. In another example embodiment, the mucous module 136 is insertable into the chest tube 156 (e.g., by disconnecting the coupler 154) and / or through the trach opening 158. A common procedure involved with tracheostomy tube management is the use of suction to remove excessive secretions or aspirated material from the tracheostomy tube. Advantageously, the tracheostomy task trainer 100 including the mucous module 136 allows a user to practice suction prior to performing it on a tracheostomy patient.

[0028] Further, tracheostomy patients undergo CPR when a blockage occurs for a prolonged period of time, inhibiting the tracheostomy patients breathing. In another example embodiment, tracheostomy patients utilize rescue breathing with a resuscitator bag and / or CPR when the tracheostomy tube 170 becomes blocked with mucous and / or or some other emergent reason that inhibits the tracheostomy patient's breathing leading to respiratory distress and / or failure. In one example embodiment, the prior to rescue breathing, the head 102 is placed into the trach position.

[0029] In one example embodiment, bag rescue breathing with a resuscitator bag is applied to the tracheostomy tube 170 that is inserted into the tracheostomy opening 112 and trach tube opening 158. The lung bag 160 will inflate in proportion to how much air is squeezed into the trach from the resuscitator bag. The inflation of the lung bag 160 will lift an anterior portion of the chest 114 to simulate chest rise, which provides real life feedback for rescue breathing. Inanother example embodiment, the bag rescue breathing is applied to the nose 104 and mouth 106 using a mask. This bag rescue breathing is applied to teach wherein the tracheostomy tube 170 cannot be inserted into the tracheostomy opening 112 and trach tube opening 158 due to a routine or emergent trach change. Bag rescue breathing is only effective if the tracheostomy opening 1 12 and trach tube opening 158 are occluded while giving rescue breaths using a mask over the nose 104 and mouth 106. The tracheostomy task trainer 100 teaches that when bag rescue breathing is performed correctly, (e.g., the tracheostomy opening 112 and trach tube opening 158 are occluded during rescue breathing), the lung bag 160 will inflate causing the anterior wall of the chest 114 to lift, which provides real life feedback that the bag rescue breathing is being done effectively.

[0030] In another example embodiment, a person provides nasal or oral rescue breaths with their mouth over the nose 104 and mouth 106, or over the mouth while occluding the nose 104. In this example embodiment, the nasal or oral rescue breathing is applied when the tracheostomy tube 170 cannot be inserted into the tracheostomy opening 112 and trach tube opening 158 due to a routine or emergent trach change. This nasal or oral rescue breathing is only effective if the tracheostomy opening 112 and trach tube opening 158 are occluded while giving the nasal or oral rescue breaths. If the nasal or oral rescue breathing is done correctly, the lung bag 160 will inflate causing the anterior wall of chest 114 to lift, which provides real life feedback that the lungs are receiving air is done effectively.

[0031] In one example embodiment, such as illustrated in FIGS. 1 and 10, the tracheostomy trainer 100 includes a spring 162 coupled to a back interior portion 114a of the chest 114. The spring 162 in conjunction with the lung bag 160 provides haptic feedback that mimics real world CPR. Further, caretakers of tracheostomy patients can practice suctioning (e.g, tracheostomy tube 170 and / or oral), stoma cleaning and trach tie change, trach change(replacement), rescue breathing, and CPR utilizing the tracheostomy trainer 100.

[0032] Illustrated in the example embodiment of FIG. 12 is a method 1200 of using the tracheostomy task trainer 100. At 1202, a user positions the tracheostomy task trainer 100 into a trach position to align the tracheostomy opening 112 and the trach opening 158. In one example embodiment, the tracheostomy opening 112 and the trach opening 158 are coupled and thus automatically aligned. At 1204, the tracheostomy tube 170 is inserted into the aligned tracheostomy opening 112 and trach opening 158. At 1206, an optional step of suctioning mucous suppled by the mucous module 136 is suctioned from the tracheostomy tube 170. At 1208, a second optional step of cleaning the tracheostomy tube 170 and / or surrounding area is performed. Both steps 1206, and 1208 can both be performed separately or in sequence. At 1210, the cannula 174 is inserted into the tracheostomy tube. Step 1210 is performed when the tracheostomy tube 170 is not a simple tube. At 1212, the cannula is removed from the tracheostomy tube 170. At 1214. an optional step of performing CPR on the tracheostomy task trainer is performed. At 1216. an optional step of performing rescue breathing on the tracheostomy task trainer is performed. Steps 1214 and 1216 can be performed before or after any step in the method 1200. At 1218, the tracheostomy tube 170 is removed from the aligned tracheostomy opening 112 and trach opening 158. In one example embodiment, the tracheostomy tube 170 is removal is emergent or routine. The method 1200 can be continued at step 1202.

[0033] In another example embodiment, a tube system mimicking a stomach is located within the chest 114 of the tracheostomy task trainer 100, wherein a stoma of a gastric tube is provided for training a user how to interact with, maintain, and clean a gastric tube.

[0034] The benefits, advantages, solutions to problems, and any element(s) that maycause any benefit, advantage, or solution to occur or become more pronounced are not to be construed as a critical, required, or essential features or elements of any or all the claims. The disclosure is defined solely by the appended claims including any amendments made during the pendency of this application and all equivalents of those claims as issued.

[0035] Moreover in this document, relational terms such as first and second, top and bottom, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. The terms "comprises," "comprising," “has”, “having,” “includes”, “including,” “contains”, “containing” or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises, has, includes, contains a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. An element proceeded by “comprises ...a”, “has ...a”, “includes ...a”, “contains ...a” does not, without more constraints, preclude the existence of additional identical elements in the process, method, article, or apparatus that comprises, has, includes, contains the element. The terms “a” and “an” are defined as one or more unless explicitly stated otherwise herein. The terms “substantially”, “essentially”, “approximately”, “about” or any other version thereof, are defined as being close to as understood by one of ordinary skill in the art. In one non-limiting embodiment the terms are defined to be within for example 10%, in another possible embodiment within 5%, in another possible embodiment within 1%, and in another possible embodiment within 0.5%. The term “coupled” as used herein is defined as connected or in contact either temporarily or permanently, although not necessarily directly and not necessarily mechanically. A device or structure that is “configured” in a certain way is configured in at least that way, but may also be configured inways that are not listed.

[0036] To the extent that the materials for any of the foregoing embodiments or components thereof are not specified, it is to be appreciated that suitable materials would be known by one of ordinary skill in the art for the intended purposes.

[0037] The Abstract of the Disclosure is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. In addition, in the foregoing Detailed Description, it can be seen that various features are grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed embodiments require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed embodiment. Thus the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separately claimed subject matter.

Claims

CLAIMSWhat is claimed is:

1. A tracheostomy task trainer comprising: a head defining a mouth, the head pivotably connected to a neck and chest, the head, neck and chest defining an interior space, the neck defining a tracheostomy opening; and a tube entrance coupled to the mouth, an upper airway tube fluidly coupling a chest tube to the tube entrance, the upper airway tube residing at least partially in the head and at least partially in the neck, and the chest tube fluidly coupling the upper airway tube to a lung bag, the chest tube residing at least partially within the chest, and the lung bag residing within the chest, at least one of the upper airway tube or the chest tube defining a trach tube opening, the upper airway tube, the chest tube, and the lung bag comprising an air tight fluid path, wherein fluid enters and exits the air tight fluid path via at ieast one of the mouth and the trach tube opening.

2. The tracheostomy task trainer of claim 1, comprising wherein the head is pivotably connected to the neck by a coupler.

3. The tracheostomy task trainer of claim 1, wherein the tube entrance defines an entrance to the upper airway tube, the upper airway tube defining an airtight space within the head and at least partially into the neck.

4. The tracheostomy task trainer of claim 1, wherein the trach tube opening and thetracheostomy opening are a same size, and the track tube opening aligns with the tracheostomy opening.

5. The tracheostomy task trainer of claim 1, further comprising one or more openings in the head above the mouth, the one or more openings mimicking nostrils the one or more openings fluidly coupled to the upper airway tube.

6. The tracheostomy task trainer of claim 1, wherein the track tube opening aligns with the tracheostomy opening, wherein a combination of the trach tube opening and the tracheostomy opening mimic a stoma in a tracheostomy patient.

7. The tracheostomy task trainer of claim 1, wherein the trach tube opening aligns with the tracheostomy opening defining a path for insertion of a tracheostomy tube.

8. The tracheostomy task trainer of claim 7, further wherein, the tracheostomy tube is removably housed within the trach tube opening and the tracheostomy opening.

9. The tracheostomy task trainer of claim 7, wherein, responsive to the head being positioned in a trach position and a tracheostomy tube not being housed with the path of insertion, rescue breathing through at least one of the nose or mouth will result in inflation of the lung bag, wherein the trach tube opening and the tracheostomy opening are occluded.

10. The tracheostomy task trainer of claim 7, further wherein, responsive to the head being positioned in a trach position and a tracheostomy tube not being housed with the pathof insertion, rescue breathing through at least one of the nose or mouth will not result in inflation of the lung bag, wherein the trach tube opening and the tracheostomy opening are not occluded.

11. A method of using a tracheostomy task trainer, the method comprising: positioning a head of the tracheostomy task trainer into a trach position, the head pivotably connected to a neck, the head, neck and chest defining an interior space, the head defining a mouth, wherein a tube entrance is coupled to the mouth, the interior space housing an upper airway tube fluidly coupling a chest tube to the tube entrance, the chest tube coupled to a lung bag housed within the chest, the neck defining a tracheostomy opening, the upper airway tube defining a trach tube opening, wherein the trach position allows air flow from the mouth and / or nose to the lung bag; and inserting a tracheostomy tube into the tracheostomy opening with the trach tube opening; and removing the tracheostomy tube from the tracheostomy opening with the trach tube opening.

12. The method of claim 11, further comprising inserting an inner cannula into an inserted tracheostomy tube.

13. The method of claim 12, further comprising, prior to insertion of the inner cannula, suctioning the inserted tracheostomy tube.

14. The method of claim 12, further comprising prior to insertion of the inner cannula suctioning the inserted tracheostomy tube, wherein the tracheostomy task trainer houses amucous module, wherein suction removes raucous supplied by the mucous module.

15. The method of claim I I, further comprising performing one of CPR or rescue breathing on the tracheostomy task trainer, wherein CPR is performed by interacting with the chest, wherein the chest tube is coupled to the lung bag comprising to define an air tight fluid path.

16. A tracheostomy task trainer comprising: a head defining a mouth and nose, the head pivotably connected to a neck and chest, the head, neck and chest defining an interior space, the neck defining a tracheostomy opening; and a tube entrance coupled to the mouth, an upper airway tube fluidly coupling a chest tube to the tube entrance, the upper airway tube residing at least partially in the head and at least partially in the neck, and the chest tube fluidly coupling the upper airway tube to a lung bag, the chest tube residing at least partially within the chest, and the lung bag residing within the chest, at least one of the upper airway tube or the chest tube defining a trach tube opening, the upper airway tube, the chest tube, and the lung bag comprising an air tight fluid path, wherein fluid enters and exits the air tight fluid path via at least one of the mouth, the nose and the trach tube opening, responsive to the head being positioned in a trach position.

17. The tracheostomy task trainer of claim 16, further comprising a mucous module housed within the chest tube, the mucous module comprising a viscous material that mimics mucous.

18. The tracheostomy task trainer of claim 16, wherein a combination of the trach tube opening and the tracheostomy opening mimic a stoma in a tracheostomy patient.

19. The tracheostomy task trainer of claim 16, comprising wherein the head is pivotably connected to the neck by a coupler, wherein the head pivots about the coupler to enter into a trach position, the trach position comprises wherein the head is tilted a trach angle relative to the neck, as measured from a bottom surface of the head and a top surface of the neck, wherein the trach angle is between 70° to about 110°.

20. The tracheostomy task trainer of claim 16, wherein the tube entrance defines an entrance to the upper airway tube, the upper airway tube defining an airtight space within the head and at least partially into the neck.

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