Tracheostomy trainer device and related method thereof

A training device and related method designed to provide a user or trainee with a realistic tactile sensation or feel for inserting a penetrating device, such as a tracheotomy tube, into the stoma of a subject. The device and method provides a means for providing the user with a high level of initial resistance followed by a relatively quick transition to a lower level of resistance. The resistance will change after the user has pushed the penetrating device past a certain threshold of force or displacement. The resulting transition to a lower level of force, or “pop”, provides the user with a realistic feel to prepare them for procedures on the stoma of an actual subject. A user may then become acclimated to the feel of proper insertion technique. The training device may also be used to train care, cleaning, maintenance, suction, and ventilation of a subject as necessary.

TECHNICAL FIELD

This invention relates generally to the field of medical training devices. More specifically, the invention is directed towards a training device for lay people who may need to know how to care for a patient with a tracheostomy.

BACKGROUND

There are products on the market that allow a user to practice or be trained in tracheostomy care, but these products are aimed at creating a lifelike visual representation of the patient. However, the present inventor recognizes that it is important for a user or trainee to experience the tactile sensations of inserting a tracheotomy tube, and performing other procedures or activities regarding the tracheostomy. Also, the majority of products currently on the market are large, expensive, and bulky.

In summary, there is still a need for a tracheostomy trainer device that allows a user to gain experience in the tactile sensation of inserting a tracheotomy tube and in performing other procedures on a patient that has a tracheostomy.

OVERVIEW

A patient with a tracheostomy requires special care and attention. As a result, when a patient with a tracheostomy is discharged from the hospital, it is important that persons who will participate in the care of that patient are trained in proper insertion, removal, and maintenance of the tracheotomy tube that passes through the tracheostomy.

An aspect of an embodiment of the present invention device provides the user with an inexpensive, portable, and convenient method to practice insertion or cannulation of a tracheotomy tube into a tracheostomy. The device is intended to create a realistic feeling of insertion of the tracheostomy tube. In particular, the device is well suited for creating a high level of initial resistance that quickly transitions into a lower level of resistance once the tracheotomy tube has passed a certain level of force and insertion. The combination of a surface with an aperture with a diaphragm that provides either another aperture of smaller size or a slit valve allows for a staggered two-level resistance that is similar to that of an actual patient tracheostomy. This recreates the tactile sensations of insertion of a tracheotomy tube into a patient for the user providing a real-life feel. Furthermore, the tracheostomy trainer device is inexpensive to produce, portable, and may be provided as a self contained kit that is easily transported and stored. The device may be produced in a way so as to be light weight and hand held.

The device can also be used for a number of other procedures or activities that are necessary for a patient with a tracheostomy and tracheotomy tube. Procedures, in addition to insertion or cannulation, may include suction, ventilation, cleaning, care, and other maintenance procedures. The device allows the user to gain an appreciation and become acclimated to the feeling and tactile experience that they will encounter during the care of a patient.

An aspect of an embodiment of the present invention provides, but not limited thereto, a device for training an operator to care for a subject with a tracheostomy. The device may comprise: a rigid or semi-rigid surface; the surface containing at least one surface aperture; at least one diaphragm in communication with the rigid or semi-rigid surface; at least one diaphragm aperture in each of the at least one diaphragm; the at least one diaphragm aperture being smaller in size than the surface aperture; the at least one diaphragm aperture being configured for an interference fit with an outer portion of a tracheotomy tube or penetrating instrument; the interference fit configured to produce an initial resistance to insertion of the tracheotomy tube or penetrating instrument followed by lower resistance after the tracheotomy tube or penetrating instrument is displaced past a threshold of the at least one diaphragm aperture causing a sudden change in resistance; and the sudden change in resistance configured to provide the inexperienced operator with a tactile sensation similar to that of insertion of a tracheotomy tube into the tracheostomy of the subject.

An aspect of an embodiment of the present invention provides, but not limited thereto, a method for training an operator to care for a subject with a tracheostomy. The method may comprise: providing a rigid or semi-rigid surface; providing at least one diaphragm in communication with the rigid or semi-rigid surface, wherein the at least one diaphragm includes a diaphragm aperture; and inserting a tracheotomy tube or penetrating instrument into the at least one diaphragm aperture causing interference between the tracheotomy tube or penetrating instrument and the diaphragm, wherein the interference produces an initial resistance to insertion of the tracheotomy tube or penetrating instrument followed by lower resistance after the tracheotomy tube or penetrating instrument is displaced past a threshold of the at least one diaphragm aperture causing a sudden change in resistance.

An aspect of an embodiment of the present invention provides, but not limited thereto, a training device (and related method of use and manufacture) designed to provide a user or trainee with a realistic tactile sensation or feel for inserting a penetrating device, such as a tracheotomy tube, into the stoma of a subject. The device (and related method) provides a means for providing the user with a high level of initial resistance followed by a relatively quick transition to a lower level of resistance. The resistance will change after the user has pushed the penetrating device past a certain threshold of force or displacement. The resulting transition to a lower level of force, or “pop”, provides the user with a realistic feel to prepare them for procedures on the stoma of an actual subject. A user may then become acclimated to the feel of proper insertion technique. The training device (and related method) may also be used to train care, cleaning, maintenance, suction, and ventilation of a subject as necessary.

These and other objects, along with advantages and features of various aspects of embodiments of the invention disclosed herein, will be made more apparent from the description, drawings and claims that follow.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

FIG. 1provides a back view schematic illustration of an aspect of an embodiment of the tracheostomy trainer device1. The device1may be comprised of, but not limited to, a surface11having an outer side (not shown) and an inner side12. The surface11has a surface aperture42having a diameter DSin communication with a diaphragm21, which has a diaphragm aperture41having a diameter DD. In this illustration, the diaphragm21is in communication with the outer side of the surface11, and the view is taken from the direction of the inner side12(or back side). Diameters DSand DDare related in that DSis larger than DDproviding for a delta57between DSand DD. The delta may be increased or decreased as desired or required for carrying out the aspects of the various embodiments of the invention disclosed herein.

FIG. 2provides a schematic illustration of a side sectional view of an aspect of an embodiment of the device1. Shown from the side, the inner side12and outer side13of the surface11are visible. Here, it can be seen that the surface11has a surface aperture42having a diameter of DS. The surface aperture42is in communication with the diaphragm21, which has its own diaphragm aperture41, also having a diameter of DD. In this view, it can be more clearly seen that the surface aperture42is larger than the diaphragm aperture41which creates a delta57between the surface aperture42and the diaphragm aperture41. Said differently, it can be seen that DSis larger than DDcreating the delta57.

Referring to bothFIG. 1andFIG. 2, it should be appreciated that there are a number of suitable materials that can be used to construct both the surface11and the diaphragm21. The list of possible materials may include, but is not limited to, metals, ceramics, glass, plastics, polymers, rubber, elastomeric compounds, or any combination thereof. In one aspect of an embodiment of the present invention, it should be appreciated that the material selected for the surface11is preferably rigid or semi-rigid. Rigid materials are those which do not appreciably deflect during their normal use in function. Said differently, a rigid material is one where the flexure of the material does not add to or enhance the function of the device1, but rather is only a side effect of its use. A semi-rigid material is one that does intentionally flex during use for the enhancement of function, in this case the recreation of a realistic tactile sensation of inserting a tracheotomy tube through a patient tracheostomy, but that the material does not permanently deform during normal use or have a lasting change in its dimensions or properties.

Still referring toFIG. 1andFIG. 2, it should also be appreciated that the illustrations shown are not to scale, and are not to be construed as limiting the device1to any particular geometry. Notably, in an aspect of an embodiment of the present invention, the diaphragm21may take on a number of different geometries, shapes, or locations. For instance, the diaphragm21may be located on the inner side12or outer side13of the surface11. The diaphragm21may be mounted or attached to the surface11in any number of ways, including, but not limited to, the use of fasteners, adhesives, or to be molded directly onto the surface11. Furthermore, multiple diaphragms may be used on either the inner side12or outer side13of the surface11, or both the inner side12and outer side13simultaneously. It should also be appreciated that the diaphragm21may take on a number of geometries, including that of a grommet. The diaphragm21may also have multiple threshold surfaces sized as DD, or may pass through and wrap around the surface aperture42.

FIG. 3provides a schematic sectional view of the device1being penetrated by the outer cannula32of a tracheotomy tube. Once again, the surface11is shown with an inner side12and outer side13. The surface11is shown with a surface aperture42, sized at a diameter DS. The surface aperture42and the surface11are in communication with a diaphragm21having a diaphragm aperture41sized at diameter DD.FIG. 3further shows that the diaphragm21is penetrated through the diaphragm aperture41by the outer cannula32of a tracheotomy tube. The outer cannula32has an outer diameter of DC. It should be appreciated that the diameter DCof the outer cannula32is greater in size than the diaphragm aperture41and smaller than the surface aperture42. This difference in size creates an interference I which is defined by the difference between the diameter DCof the outer cannula32and the diameter DDof the diaphragm aperture41.

It should be appreciated that a user may alter, modify, or specify the tactile sensation received by the user, the force necessary to penetrate the diaphragm with the cannula of a tracheotomy tube, and the change in force from the initial application of the tracheotomy tube cannula, through penetration, and then further movement of the tube through the diaphragm. A number of parameters may be adjusted, set, or modified in order to create the desired feel, and to customize the device to different tracheotomy tubes having different sizes of cannula or different penetrative properties. For example, the choice of materials, both for the diaphragm and the surface, may be chosen based on their relative stiffness, pliability, and frictional properties. It should also be appreciated that the mechanical and dynamic properties of the device may be altered by varying the relative sizes of the surface aperture and the diaphragm aperture. Different tactile sensations for the user may be achieved, for example, by having a larger or smaller delta between the surface aperture and the diaphragm aperture. Similarly, different amounts of interference between the diaphragm and the outer cannula of a tracheotomy tube will create different sensations and tactile responses for the user. The diaphragm may also take on a number of different geometries, including different methods of attachment, different thicknesses, and a larger number of interference thresholds that allow a user to tailor a particular feel for different sizes and materials of tracheotomy tubes, or to customize the device to recreate the tactile sensations of differences in anatomy that may be due to age, sex, or the relative size of a patient.

FIG. 4provides a schematic sectional side view of an aspect of an embodiment of the device1in communication with the ground or a base3and a stand2. In this view, the surface11can be seen to have an inner side12and an outer side13. The surface11has a surface aperture42with diameter DS. The surface11is in communication with a diaphragm21, which has a diaphragm aperture41of diameter DD. As shown, the outer cannula32of a tracheotomy tube having a diameter DCis poised at the threshold TH of the diaphragm aperture41. In an aspect of an embodiment of the device1, the device may be in communication with a stand2or similar means for propping or holding the device up above the ground or a base3. It should be appreciated that the device1may itself include the base3, or that the base3may consist of the ground, a table, or other suitable surface that the device1may be used on in conjunction with the stand2.

FIG. 5provides a schematic sectional side view of an aspect of an embodiment of the device1in communication with the ground or a base3and a stand2. In this view, the surface11can be seen to have an inner side12and an outer side13. The surface11has a surface aperture42with diameter DS. The surface11is in communication with a diaphragm21, which has a diaphragm aperture41of diameter DD. As shown, the outer cannula32of a tracheotomy tube having a diameter DChas penetrated the threshold of the diaphragm aperture41creating an interference I between the outer cannula32and the diaphragm21which recreates the tactile sensation of a user pressing a tracheotomy tube through the tracheostomy of a patient. In an aspect of an embodiment of the device1, the device may be in communication with a stand2or similar means for propping or holding the device up above the ground or a base3. It should be appreciated that the device1may itself include the base3, or that the base3may consist of the ground, a table, or other suitable surface that the device1may be used on in conjunction with the stand2.

FIG. 6provides a schematic perspective view of an aspect of an embodiment of the present invention. The device1has a surface11with an outer side13. The surface11is in communication with a diaphragm21having a diaphragm aperture41. The surface11has been configured into a cylindrical shape having a bottom15. It should be appreciated that the surface11may be configured into a hollow cylinder preserving a space inside the surface11that may be used for storage or other purposes.

FIG. 7provides a schematic view of an aspect of an embodiment of the present invention. The device1has a surface11with an outer side13. The surface11is in communication with a diaphragm21having a diaphragm aperture41. The surface11has been configured into a semi-cylindrical shape having a bottom15.

It should be appreciated that the surface of the device may be configured into a number of different shapes to provide various functional properties other than serving as the support for the diaphragm. For instance, the surface may be relatively planar to allow for easy stacking, storage, or shipping. The surface may also be configured into any three dimensional shape, such as a cylinder, semi cylinder, or any other shape (or housing) that is desired or required. In an aspect of an embodiment of the present invention, the surface may be shaped so as to be open, for example, having one or more openings at any location on the device allowing for access to the inner portions. In another aspect of an embodiment of the present invention, the surface may be configured to have openings which can be selectively closed or opened by lids, which may be hinged, attached via tether, or completely detachable. As such, the surface may be configured to have an interior space that may provide storage for replacement parts or other items which may be included with the device, such as in a kit.

It should also be appreciated that the device may be provided with a flat panel disposed across from the surface aperture and diaphragm. This flat portion of the surface would allow the device to be placed on a table, floor, bed, or other work area and provide stability for the user during training. The flat portion of the surface would also provide additional functionality by providing an ideal location for instructional materials. The instructions may be included as, but not limited to, a relief sculpture of the relevant anatomy, optionally with molded in or applied color for differentiation of particular areas, or an area for printing, coloring, or the location of a decal for instructional and educational materials for the user.

FIG. 8provides a back view schematic illustration of an aspect of an embodiment of the present invention. The device1has a surface11having an inner side12and an outer side (not shown). The surface11is in communication with a diaphragm21. In this representation, the diaphragm21is in communication with the outer side of the surface11and the view is taken from the direction of the inner side12. The diaphragm21is disposed over the surface aperture42. In an aspect of an embodiment of the present invention, the diaphragm21has a slit valve covering the surface aperture42. The slit valve may be comprised of, but is not limited to, one or more panels56containing or defining one or more slits55. The slit valve may dilate on application of a tracheotomy tube to provide the initial resistance to penetration and to provide the user with the resultant tactile sensation of penetrating the tracheostomy of an actual patient.

FIG. 9provides a side view schematic sectional illustration of an aspect of an embodiment of the present invention. The device1has a surface11with an inner side12and an outer side13. The surface11has a surface aperture42with a diameter of DSthat is in communication with a diaphragm21. The diaphragm21provides a slit valve comprised of, but not limited to, one or more panels56containing or defining one or more slits55. In this particular representation of an aspect of an embodiment of the present invention, the slit valve contains two panels56and one slit55that allows for dilation and the passage of a tracheotomy tube through the diaphragm21.

FIG. 10provides a side view schematic sectional illustration of an aspect of an embodiment of the present invention. The device1has a surface11with an inner side12and an outer side13. The surface11has a surface aperture42and is in communication with a diaphragm21. The diaphragm21provides a slit valve comprised of, but not limited to, two panels56. The panels56are flexed and disposed towards the inner side12of the surface11due to the penetration of the outer cannula32past the threshold TH. The penetration of the tracheotomy tube has caused a region of interference I. It should be appreciated that the diameter DCof the outer cannula32is less than the diameter DSof the surface aperture42.

FIG. 11provides a schematic illustration of an aspect of an embodiment of the present invention. Here, the diaphragm21is shown as a slit valve comprised of panels56which are defined by slits55. In this representation, the slit valve has four panels55which are defined by four slits55. However, it should be appreciated that the number and shape of panels56and slits55may be modified as desired or required to provide the functionality required by any particular aspect of an embodiment of the present invention.

It should be appreciated that the diaphragm in the form of a slit valve may be modified in a number of ways, including but not limited to the same ways that an aperture diaphragm may be modified, in order to provide the desired tactile sensations to the user. For instance, the slit valve may be composed of a number of different materials to provide different qualities of flexibility, pliability, or friction. The geometry of the slit valve may also be modified in order to provide different values of resistance and different qualities of change in resistance as the slit valve is penetrated by the tracheotomy tube. For instance, the slit valve diaphragm may be located on the inside or outside of the surface of the device, or both. The slit valve may also be comprised of one piece of material that has been cut to provide a number of slits and panels, or it may be comprised of multiple different pieces of material, the boundaries of which define the slits that allow for dilation and penetration. Other aspects of the slit valve may also be altered to provide different tactile sensations to the user. For instance, the thickness of the material, slit size, both in length and width of the slits, and the individual panels may placed so as to provide slits which consist of overlapping portions of panels. The device may also be altered by having multiple slit valves to provide multiple levels of penetration, and that the ratio of the surface opening to the outer cannula size of the tracheotomy tube may be used to adjust the mechanical and dynamic properties of the device.

It should also be appreciated that any of the listed potential modifications to the aperture diaphragm may be applied to the slit valve diaphragm, and vice versa, unless such modifications would be non-functional. It should also be appreciated that other modifications not listed would be possible to either style of diaphragm in order to produce the desired results.

It should be appreciated that a number of different geometries or device configurations may be used to provide a realistic feel or tactile sensation to the user. For instance, an alternative method of mounting the diaphragm to the surface may be used. As an example of an aspect of an embodiment of the present invention, the diaphragm may be molded or formed directly onto the surface aperture. As opposed to mounting the diaphragm either to the inner side or outer side of the surface, the diaphragm may be attached or molded directly onto the inner boundary of the surface aperture, providing a smooth appearance to the user. The transition from surface material to diaphragm material may or may not include a seam in this case. All of the methods for adjusting the feel or sensation to the user for a diaphragm would be available for these embodiments.

Another example of an aspect of an embodiment of the present invention would be for the surface itself to provide a realistic tactile sensation or feel to the user. In this case, the surface itself would be molded, cut, modified, or otherwise formed to provide this functionality. For example, the surface itself may be directly formed with a slit valve (or any other access means or mechanism as provided throughout this disclosure) where the surface aperture would otherwise be located. The surface aperture itself may me formed in such a way as to provide dilation upon insertion of a penetrating instrument by having a surface aperture diameter that is smaller than the diameter of the penetrating instrument. The surface may also be formed so as to have an integrated flap, panel or door that the user may force a penetrating instrument past so as to provide realistic feel or tactile sensation that recreates the insertion of a penetrating instrument into a subject stoma. In the case of the surface itself providing realistic feel to the user, the resulting tactile sensation may be adjusted as desired or required through the following parameters: material choice, aperture size, type of aperture obstruction, if any, aperture size, amount of interference between the aperture and the tracheotomy tube or penetrating instrument, threshold geometry (i.e. rounded, square, napier profile, tapered, etc.), thickness of surface material, and changes to the thickness of the surface material at or near the penetration site (e.g. thinning, thickening, or variations thereof). The previous list of parameters is not an exhaustive list, and other opportunities for modification of feel are possible. Moreover, any combinations of such parameters may be implemented.

Yet another example of an aspect of an embodiment of the present invention may allow for the diaphragm to be replaced with a mechanical resistance device that would provide realistic tactile sensations to the user. For instance, the surface aperture may be obscured or covered by a small flap, panel or door that is mechanically linked to the surface. A hinge, spring, flexible tether, or other means may provide a mounting that allows for high initial resistance followed by a fast transition to lower resistance to penetration past a certain displacement or application of force. The means for attachment of the flap, panel or door should provide the proper resistance profile and should assist in locating the moveable flap, panel, or door at the site of the surface aperture. It should be appreciated that multiple panels, flaps, or doors may be used at a surface aperture, and these multiple panels, flaps, or doors may share or have separate linking means. It should also be appreciated that the feel for the user may be adjusted or modified as desired or required by altering the parameters of the specific linking means that is used in that specific embodiment of the present invention. Furthermore, the tactile sensation experienced by the user may be adjusted through adjusting the geometry, size, material, thickness, or relative amount of covering that the flap, panel or door provides; or any combination thereof. That is, the flaps, panels or doors may cover the entire surface aperture, or it may only cover a portion of the surface aperture leaving a portion of the surface aperture exposed.

FIG. 12provides a schematic illustration of a tracheotomy tube65inserted through a tracheostomy67(e.g., stoma) into the trachea64. Various parts of anatomy are displayed for illustrative purposes, including the thyroid cartilage61, cricoid cartilage62, esophagus63, and tracheal cartilage66. Also for illustrative purposes, the tracheotomy tube65components are shown, including the inner cannula133, retainer135, inflatable cuff137, pilot balloon138, and cuff inflation line139.

FIG. 13provides a schematic illustration of a tracheotomy tube device with several parts disassembled for illustrative purposes. A tracheotomy tube device may be comprised of parts such as an outer cannula32, inner cannula33, obturator34, retainer for outer cannula35, retainer eyelets36, an inflatable cuff37, a pilot balloon38, a cuff inflation line39, and a trachea plug40. It should be appreciated that the shown tracheotomy tube is for illustration purposes only. Actual tracheotomy tubes that may be used with the tracheostomy training device may vary in their shape, size, or number and type of included parts.

FIG. 14provides a front view schematic illustration of an aspect of an embodiment of the present invention wherein the device1has a tracheotomy tube mounted to it. The device1is shown with a surface11having an inner side (not shown) and an outer side13. The device1is position on a base or surface3which may or may not be an integral part of the device1. A strap43is mounted around the outer side13of the surface11of the device1, and is in communication with the eyelets36of the tracheotomy tube. The inner cannula33is visible in this representation of the present invention.FIG. 14illustrates how the tracheotomy tube may be mounted onto the device1during use.

FIG. 15provides a schematic illustration of an aspect of an embodiment of the device1provided to the end user as part of a kit for training a user in various aspects of tracheostomy care and maintenance. As illustrated, the device1has a surface11with an outer side13and a bottom15. In this depiction of the device1the bottom15is integrated into the surface11, though it should be appreciated that the bottom15may also be a replaceable or removable part. The device1also comes equipped with a lid14to allow for selective access to the interior of the device, and to allow for the device1to enclose or contain other parts of the kit. It should be appreciated that the kit may be delivered with the device1, or the kit may be assembled on site from the device1and equipment or components that are available in a hospital, doctor's office, the home of the patient, or purchased from a medical supply company. In an aspect of an embodiment of the present invention, the device1is delivered with mechanical test lungs44, a syringe45, a ventilation strap46, a drain sponge47, a strap43, an inner cannula33, a retainer35, a pilot balloon38, and a cuff inflation line39.

FIG. 16provides a schematic illustration of an aspect of an embodiment of the present invention as used to simulate the insertion or cannulation of a tracheotomy tube. The device1is shown with a surface11that has an inner side (not shown) and an outer side13. A diaphragm21is in communication with the surface1land has a diaphragm aperture41. InFIG. 16, a user4can be seen using the device1to simulate the insertion of a tracheotomy tube. As illustrated, the tracheotomy tube consists of an outer cannula32with a user inflatable cuff37. The outer cannula32is also in communication with a retainer35and an obturator34. A cuff inflation line39is also visible, and allows the user to inflate the cuff37. In this representation of an aspect of an embodiment of the present invention, the user4is performing insertion or cannulation of the outer cannula32into the diaphragm aperture41, and is simultaneously applying a lubricant48from a lubricant package53. It should be appreciated thatFIG. 16is for illustrative purposes only, and should not be construed as to limit the invention to this particular representation. The device1may take on many more forms, and it may be used with a number of different styles, shapes, or sizes of tracheotomy tube. Also, additional parts or features may be present, and some features, for example the lubricant48, may not be necessary for all simulation purposes.

One feature of an aspect of an embodiment of the present invention is to provide a device that allows for the training of a user in the insertion or cannulation of a tracheotomy tube into the tracheostomy (or stoma) of a patient. In particular, the device is intended to offer a realistic tactile experience to the user. That is, the user should feel an initial high resistance, followed by a fast transition to a lower resistance as the tracheotomy tube passes through the diaphragm into the device. A user may describe this feeling as a “pop”. The intention of the device is to acclimate and educate a user on the proper insertion procedures, and what a user should expect to feel during the procedure. This realistic tactile sensation may or may not be accompanied by a realistic appearance of the device. It should be appreciated that an embodiment of the device may be applicable to any type of stoma of various anatomies.

It should be appreciated that an embodiment of the present invention may include a surface or related components that are opaque, transparent, or translucent (or any combination thereof). Moreover, for a opaque surface (device material) then the user may need to rely on tactile sensations rather than visual sensation.

FIG. 17provides a schematic illustration of an aspect of an embodiment of the present invention where the device1is used to demonstrate to a user4the care and cleaning of the tracheostomy opening, here represented by the diaphragm aperture (not visible). The device1has a surface11with an outer side13. In this particular representation, the device1is shown with a bottom15and a removable and replaceable lid14. It should be appreciated that the bottom15and lid14are not essential to the operation of the device, and may be included or omitted as desired or required. The surface11is in communication with a diaphragm21which already has a tracheotomy tube inserted through it. The outer portions of the tracheotomy tube may be seen inFIG. 17as represented by the portions that are visible to the user as represented by the inner cannula33, retainer35, and cuff inflation line39. The user4then has access to the portions that they would normally see during use with an actual patient. The tracheotomy tube is held onto the device1by a strap43, as is commonly used with an actual patient. The user4may then practice the care and cleaning of the patient tracheostomy. For example, inFIG. 17, the user4is replacing a drain sponge47that is used to maintain a clean and dry area around the tracheotomy tube. It should be appreciated that this is only one illustrated example of care, cleaning, and maintenance that may be simulated by the device1, and that others are also possible.

FIG. 18provides a schematic illustration of an aspect of an embodiment of the present invention wherein a user4is simulating the suctioning of the tracheotomy tube and trachea of a patient. The device1is shown with a surface11having an outer side13, a bottom15, and a removable lid14. The device1is also shown having a device plug48, which may consist of a grommet, plug, seal, or other means for sealing up a small opening in the bottom15of the device. It should be appreciated that it is not required for the device1to have a device plug48, and that the device plug48may be located anywhere on the device as desired or required for additional functionality. Furthermore, the device may be provided with multiple device plugs as needed. The device1is shown with a tracheotomy tube inserted through the diaphragm aperture (not shown). The tracheotomy tube is represented by the parts which are visible, including the inner cannula33, retainer35, and cuff inflation line39. The tracheotomy tube is held to the device1by a strap43which is attached to the retainer35. A drain sponge47is also shown for illustrative purposes. The user4is simulating the procedure of providing suction to the tracheotomy tube and trachea to remove any fluids or obstructions that may be present. In this representation, the user4is performing suction by inserting suctioning tubing49into the inner cannula33. The suctioning tubing is further connected to a tubing adapter54, which allows the suctioning tubing49to be attached to a larger or smaller size of tubing that may be attached to a suction source (not shown). It should be appreciated that the plug may be a variety of sizes including occupying an entire side of the container or housing of the device, or it may be a portion of the side of a container or housing, for example.

FIG. 19provides a schematic illustration of an alternate view of an aspect of an embodiment of the present invention during the simulation of a suction procedure. In this view, the interior of device1can be seen during the suction simulation. The device1has a surface11having an inner side12and an outer side13. The device1also has a bottom15. The inner side12of the surface11is in communication with a diaphragm21having a diaphragm aperture41. The outer cannula32of a tracheotomy tube can be seen passing through the diaphragm aperture42. The outer cannula32is in communication with a cuff37that may be inflated by the user. A drain sponge47is also shown for illustrative purposes. In this depiction of an aspect of an embodiment of the present invention, the user4is passing suctioning tubing49from the outside of the device1, through the tracheotomy tube to the inside of the device1. The end of the suctioning tubing49can be seen extending from the end of the outer cannula32and inflatable cuff37. The end of the suctioning tubing49is shown extending from the outer cannula32into simulated sputum50. It should be appreciated that the simulated sputum50may consist of any liquid or material that would be beneficial in training the user4on proper suctioning techniques.

It should also be appreciated that simulation of suctioning techniques may include other apparatus than shown inFIG. 19. The device may be modified or used as necessary to accommodate a wide variety of suctioning devices or methods. Also, it should be appreciated that the particular embodiment illustrated is not the only embodiment of the device that may be used for the simulation of suction procedures.

FIG. 20provides a schematic illustration of an aspect of an embodiment of the present invention being used to simulate ventilation and proper tracheotomy tube cuff inflation. The device1is shown having a surface11with an outer side13and an inner side12. The device1is shown in an inverted position with the bottom15located at the top ofFIG. 20. The surface11is in communication with a diaphragm21that has a diaphragm aperture (not shown). A tracheotomy tube is positioned through the diaphragm aperture, and the visible portions of the tracheotomy tube, including the inner cannula33and the retainer35are visible inFIG. 20. The tracheotomy tube is held to the device1by a strap43which is in communication with the retainer35. In this depiction of an aspect of an embodiment of the present invention, the device1has been configured with other equipment, which may or may not be included with the device1as a kit, in order to simulate ventilation and tracheotomy tube cuff inflation. In this illustration, the user4is inflating the cuff (not visible) by attaching a syringe45to the pilot balloon38and passing air through the cuff inflation line39to inflate the cuff (not visible). In an aspect of an embodiment of the present invention, the tracheotomy tube that is inserted through the diaphragm aperture has the portion of the outer cannula with the inflatable cuff inserted into a length of corrugated tubing52. This allows the user4to practice inflation of the cuff using the syringe45or other means to achieve proper cuff inflation. The user4may also connect the length of corrugated tubing52to a mechanical test lung44and connect the tracheotomy tube to a ventilation device51. The user4then may use the device1to simulate proper ventilation of a patient through a tracheotomy tube. A user4may use either a manual or mechanical ventilation device as is desired or required. It should be appreciated that a tube or conduit structure other than corrugated tubing may be used to simulate the feel of anatomy.

It should be appreciated that container may utilize an aperture vacated by a plug to provide access to or for any of the components or activities discussed herein.

It should be appreciated that the device may be provided alone, or in combination with the other equipment shown to provide a kit for the end user. The device may also be provided alone to a hospital or other care facility that may then add the necessary equipment to provide a kit to the end user. Also, it should be appreciated that the device may be used with a wide variety of equipment, and the equipment shown in the figures is for illustrative purposes only. The device may be compatible with a number of different medical devices, and it may be used in conjunction with any device that the user may need in addition to those shown in the figures and described above.

The device may also provide additional functionality based on the particular design and implementation of its features. For example, when the device is configured as a container, as illustrated inFIGS. 15-20, the device may be oriented in different ways to offer different functionality and training opportunities. ComparingFIG. 18andFIG. 19toFIG. 20, we can see that the device1may be inverted to change its functionality. InFIGS. 18 and 19, the bottom15of the device1is placed downwards, allowing it to serve as a reservoir or holding area for a fluid to be suctioned out by the user4. However, when the device1is inverted as inFIG. 20, the bottom15is now located above the opening. This provides access to the interior of the device1to allow the user4to connect a length of corrugated tubing52to allow for simulation of tracheotomy tube cuff inflation and ventilation of a patient.

An alternative method for providing added functionality is the addition of the device plug48as shown inFIG. 18. Here, the device plug48allows the bottom15to hold liquid or simulated sputum50for suctioning, or to provide support for a vessel which holds the liquid or simulated sputum50. Then, to simulate ventilation, the user4may clean out the liquid or simulated sputum50and remove the device plug48from the bottom15. The user4then would have an opening through which to feed a length of corrugated tubing as seen inFIG. 20. The user4could then simulate ventilation with the device1without having to reorient it. This may be useful in cases where the user4wishes to mount the device1permanently or semi-permanently and still retain multiple training functionalities. For instance, the device1may be attached to a pillow or mattress using forceps to maintain stability and placement during use. It should be appreciated that other mechanism may be utilized to provide stability.

Various components of the device may be reusable and/or disposable after each use. For instance,

It should be appreciated that as discussed herein, a subject may be a human or any animal. It should be appreciated that an animal may be a variety of any applicable type, including, but not limited thereto, mammal, veterinarian animal, livestock animal or pet type animal, etc. As an example, the animal may be a laboratory animal specifically selected to have certain characteristics similar to human (e.g. rat, dog, pig, monkey), etc. It should be appreciated that the subject may be any applicable human patient, for example. It should be appreciated that the dimensions provided for the device in the present disclosure are associated with humans. It should be appreciated that the scale of the dimension of the device may vary relative to the given species, animal type, or subject size. It should be appreciated that the scale of the dimension of the device may vary if utilized for other anatomical spaces or structures.

It should be appreciated that various sizes, dimensions, contours, rigidity, shapes, flexibility and materials of any of the components or portions of components in the various embodiments discussed throughout may be varied and utilized as desired or required. Similarly, locations and alignments of the various components may vary as desired or required.

It should be appreciated that any of the components or modules referred to with regards to any of the present invention embodiments discussed herein, may be integrally or separately formed with one another. Further, redundant functions or structures of the components or modules may be implemented.

It should be appreciated that the device and related components discussed herein may take on all shapes along the entire continual geometric spectrum of manipulation of x, y and z planes to provide and meet the anatomical, environmental, and structural demands and operational requirements. Moreover, locations and alignments of the various components may vary as desired or required.

EXAMPLES

Practice of an aspect of an embodiment (or embodiments) of the invention will be still more fully understood from the following example, which is presented herein for illustration only and should not be construed as limiting the invention in any way.

A device for training an operator to care for a subject with a tracheostomy. The device may comprise: a rigid or semi-rigid surface; the surface containing at least one surface aperture; at least one diaphragm in communication with the rigid or semi-rigid surface; at least one diaphragm aperture in each of the at least one diaphragm; the at least one diaphragm aperture being smaller in size than the surface aperture; the at least one diaphragm aperture being configured for an interference fit with an outer portion of a tracheotomy tube or penetrating instrument; the interference fit configured to produce an initial resistance to insertion of the tracheotomy tube or penetrating instrument followed by lower resistance after the tracheotomy tube or penetrating instrument is displaced past a threshold of the at least one diaphragm aperture causing a sudden change in resistance; and the sudden change in resistance configured to provide the inexperienced operator with a tactile sensation similar to that of insertion of a tracheotomy tube into the tracheostomy of the subject.

The device of example 1, wherein the rigid or semi-rigid surface comprises a housing. It should be appreciated that the housing may have any geometrical shape or configuration as desired or required.

The device of example 2, wherein the housing is an open cylinder.

The device of example 2, wherein the housing is an open semi-cylinder.

The device of example 1 (as well as subject matter of one or more of any combination of examples 2-4), wherein the rigid or semi-rigid surface comprises a flat surface opposite of the at least one surface aperture.

The device of example 1 (as well as subject matter of one or more of any combination of examples 2-5), further comprising instructional materials on the rigid or semi-rigid surface.

The device of example 6 (as well as subject matter of one or more of any combination of examples 2-6), wherein the instructional materials comprise a relief mold.

The device of example 7 (as well as subject matter of one or more of any combination of examples 2-7), wherein the relief mold comprises multiple colors for understanding.

The device of example 5 (as well as subject matter of one or more of any combination of examples 2-8), wherein the instructional materials comprise printing on the rigid or semi rigid surface.

The device of example 5 (as well as subject matter of one or more of any combination of examples 2-9), wherein the instructional materials comprise a decal or sticker.

The device of example 1 (as well as subject matter of one or more of any combination of examples 2-10), wherein the rigid or semi-rigid surface comprises a container.

The device of example 11 (as well as subject matter of one or more of any combination of examples 2-10), wherein the container has one open end.

The device of example 12 (as well as subject matter of one or more of any combination of examples 2-11), further comprising a repeatably removeable lid.

The device of example 11 (as well as subject matter of one or more of any combination of examples 2-10 or 12-13), further comprising a bottom aperture in the bottom of the container and a plug to close the bottom aperture.

The device of example 1 (as well as subject matter of one or more of any combination of examples 2-14), wherein the at least one diaphragm is comprised of two or more layers.

The device of example 1 (as well as subject matter of one or more of any combination of examples 2-15), wherein the at least one diaphragm is replaceable.

The device of example 1 (as well as subject matter of one or more of any combination of examples 2-16), wherein the at least on diaphragm comprises a grommet.

The device of example 1 (as well as subject matter of one or more of any combination of examples 2-17), wherein the at least one diaphragm dilates on insertion of the tracheotomy tube.

The device of example 1 (as well as subject matter of one or more of any combination of examples 2-18), wherein the at least one diaphragm aperture is coaxial with the at least one surface aperture.

The device of example 1 (as well as subject matter of one or more of any combination of examples 2-19), wherein the at least one diaphragm aperture comprise a slit valve.

The device of example 1 (as well as subject matter of one or more of any combination of examples 2-20), wherein the rigid or semi-rigid surface is opaque.

The device of example 1 (as well as subject matter of one or more of any combination of examples 2-21), wherein the device is configured to be portable.

The device of example 1 (as well as subject matter of one or more of any combination of examples 2-22), wherein the device is provided as a kit with any one or a combination of the following: cuffed tracheotomy tube, plastic corrugated tubing, tracheostomy tube ties, drain sponge, syringe, forceps, water based surgical lubricant, simulated sputum, tubing, tubing adapter, mechanical test lungs, or a manual ventilation device.

The device of example 11 (as well as subject matter of one or more of any combination of examples 2-10 and 12-23), wherein the container is configured to enclose any one or a combination of the following: cuffed tracheotomy tube, plastic corrugated tubing, tracheostomy tube ties, drain sponge, syringe, forceps, water based surgical lubricant, simulated sputum, tubing, tubing adapter, mechanical test lungs, or a manual ventilation device.

The device of example 1 (as well as subject matter of one or more of any combination of examples 2-24), wherein the device is configured for training an operator in the care of the subject with a tracheostomy in any one or a combination of the following procedures: cleaning, cannulation, suction, mechanical ventilation, manual ventilation, proper cuff inflation, or general care.

The device of example 1 (as well as subject matter of one or more of any combination of examples 2-25), wherein the rigid or semi-rigid surface is planar.

A method for training an operator to care for a subject with a tracheostomy. The method may comprise: providing a rigid or semi-rigid surface; providing at least one diaphragm in communication with the rigid or semi-rigid surface, wherein the at least one diaphragm includes a diaphragm aperture; and inserting a tracheotomy tube or penetrating instrument into the at least one diaphragm aperture causing interference between the tracheotomy tube or penetrating instrument and the diaphragm, wherein the interference produces an initial resistance to insertion of the tracheotomy tube or penetrating instrument followed by lower resistance after the tracheotomy tube or penetrating instrument is displaced past a threshold of the at least one diaphragm aperture causing a sudden change in resistance.

The method of using any of the devices or its components provided in any one or more of examples 1-26.

The method of manufacturing any of the devices or its components provided in any one or more of examples 1-26.

REFERENCES

The following patents, applications and publications as listed below and throughout this document are hereby incorporated by reference in their entirety herein. The devices, systems, compositions, and methods of various embodiments of the invention disclosed herein may utilize aspects disclosed in the following references, applications, publications and patents and which are hereby incorporated by reference herein in their entirety (and which are not admitted to be prior art with respect to the present invention by inclusion in this section):1. U.S. Patent Application Publication No. US 2012/0202180 A1, Stock, et al., “Training Device for Medical Procedures”, Aug. 9, 2012.2. U.S. Patent Application Publication No. US 2007/0218438 A1, Sanders, et al., “Tracheotomy Teaching Aid”, Sep. 20, 2007.3. U.S. Pat. No. 5,846,087, Scherer, A., “Anatomical Simulator and Method for Tracheostomy Tube Placement”, Dec. 8, 1998.4. U.S. Pat. No. 6,662,804 B2, Ortiz, A., “Tracheostomy Tube with Cuff on Inner Cannula”, Dec. 16, 2003.5. U.S. Pat. No. 4,817,598, LaBombard, D., “Tracheostomy Tube with Ring Pull Removable Inner Cannula”, Apr. 4, 1989.

In summary, while the present invention has been described with respect to specific embodiments, many modifications, variations, alterations, substitutions, and equivalents will be apparent to those skilled in the art. The present invention is not to be limited in scope by the specific embodiment described herein. Indeed, various modifications of the present invention, in addition to those described herein, will be apparent to those of skill in the art from the foregoing description and accompanying drawings. Accordingly, the invention is to be considered as limited only by the spirit and scope of the following claims (or disclosure herein), including all modifications and equivalents.

Still other embodiments will become readily apparent to those skilled in this art from reading the above-recited detailed description and drawings of certain exemplary embodiments. It should be understood that numerous variations, modifications, and additional embodiments are possible, and accordingly, all such variations, modifications, and embodiments are to be regarded as being within the spirit and scope of this application. For example, regardless of the content of any portion (e.g., title, field, background, summary, abstract, drawing figure, etc.) of this application, unless clearly specified to the contrary, there is no requirement for the inclusion in any claim herein or of any application claiming priority hereto of any particular described or illustrated activity or element, any particular sequence of such activities, or any particular interrelationship of such elements. Moreover, any activity can be repeated, any activity can be performed by multiple entities, and/or any element can be duplicated. Further, any activity or element can be excluded, the sequence of activities can vary, and/or the interrelationship of elements can vary. Unless clearly specified to the contrary, there is no requirement for any particular described or illustrated activity or element, any particular sequence or such activities, any particular size, speed, material, dimension or frequency, or any particularly interrelationship of such elements. Accordingly, the descriptions and drawings are to be regarded as illustrative in nature, and not as restrictive. Moreover, when any number or range is described herein, unless clearly stated otherwise, that number or range is approximate. When any range is described herein, unless clearly stated otherwise, that range includes all values therein and all sub ranges therein. Any information in any material (e.g., a United States/foreign patent, United States/foreign patent application, book, article, etc.) that has been incorporated by reference herein, is only incorporated by reference to the extent that no conflict exists between such information and the other statements and drawings set forth herein. In the event of such conflict, including a conflict that would render invalid any claim herein or seeking priority hereto, then any such conflicting information in such incorporated by reference material is specifically not incorporated by reference herein.