Expandable tracheostomy tube

Abstract

An expandable tracheostomy tube and methods of use thereof are disclosed. The expandable tracheostomy tube may comprise an elastic and / or expandable outer cannula and a rigid inner cannula. In turn, the rigid inner cannula (and not the expandable outer cannula) need only be replaced to downsize the tracheostomy tube, improving patient outcomes and avoiding issues such as dysphagia, aspiration, and aphonia / dysphonia. The shape of the tracheostomy tube may be personalized, such as being shaped in an oblong, rather than substantially circular, shape.

Description

009642.00052EXPANDABLE TRACHEOSTOMY TUBE AND METHODS OF USE THEREOFCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of, and priority to, U.S. Patent Application No. 63 / 704,784 filed on October 8, 2024, the content of which is expressly incorporated herein by reference in its entirety for any and all non-limiting purposes.FIELD OF USE

[0002] Aspects of the disclosure relate generally to an expandable tracheostomy tube. More particularly, aspects described herein describe an expandable tracheostomy tube that allows care providers to change and / or expand the outer diameter of the tube(s).BACKGROUND

[0003] In a tracheostomy, tracheostomy tubes may be placed through the skin and soft tissues of the anterior neck and into the trachea (the windpipe). Over 100,000 tracheostomies are performed each year in the United States. Presently, tracheostomy tubes come in different sizes, which are generally configured for different patients (e.g., different patient habitus and patient needs). In general, transitioning to a smaller tracheostomy tube size promotes better swallowing and speech outcomes, which are desirable because speech and swallow rehabilitation after a tracheostomy tube placement can be difficult. To perform such transitioning, a patient might start with a larger tube, and that tube might be downsized over time. That said, presently, to perform this down-sizing, the larger tracheostomy tube must be first removed. This introduces significant risk: for example, tracheostomy tube exchange can introduce a risk of airway obstruction due to the inability to replace the smaller tracheostomy tube through the surgical tract.SUMMARY

[0004] The following presents a simplified summary of various aspects described herein. This summary is not an extensive overview, and is not intended to identify key or critical elements or to delineate the scope of the claims. The following summary merely presents some concepts in a simplified form as an introductory prelude to the more detailed description provided below.009642.00052

[0005] Aspects described herein relate to an expandable tracheostomy tube that can, among other things, reduce risk by keeping an outer cannula in place, allowing care providers to replace only the inner cannula as desired to increase and / or decrease the size of the inner cannula. Further, the expandable tracheostomy tube uses an elastic outer cannula and rigid inner cannula to allow customization of the intraluminal tracheostomy tube. Along those lines, the expandable tracheostomy tube may permit care providers to personalize the shape of a tracheostomy for long-term tracheostomy and pediatric patients.

[0006] For instance, aspects described herein relate to an expandable tracheostomy tube comprising an expandable outer cannula configured to expand to account for a variety of different inner cannula. The expandable outer cannula may be configured to permit (e.g., allow, make easier) a patient to exhale air. The expandable outer cannula may additionally and / or alternatively one or more openings that permit a diameter of the expandable outer cannula to expand. For instance, the expandable outer cannula may be made of a flexible material. The expandable tracheostomy tube may additionally and / or alternatively comprise a substantially rigid inner cannula configured for insertion through the expandable outer cannula and into a trachea of the patient. The substantially rigid inner cannula may be configured to permit airflow into an airway of the patient. The substantially rigid inner cannula may additionally and / or alternatively be configured to be removed from the expandable outer cannula and replaced with a smaller substantially rigid inner cannula without requiring removal, from the patient, of the expandable outer cannula (e.g., withdrawal of all or portions of the outer cannula). The substantially rigid inner cannula may be a variety of shapes, such as oval-shaped.

[0007] Corresponding methods, apparatus, systems, and non-transitory computer-readable media are also within the scope of the disclosure.

[0008] These features, along with many others, are discussed in greater detail below.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The present disclosure is illustrated by way of example and not limited in the accompanying figures in which like reference numerals indicate similar elements and in which:

[0010] FIG. 1 depicts an outer cannula, which may comprise the outer portion of the expandable tracheostomy tube.009642.00052

[0011] FIG. 2 depicts an inner cannula, which may comprise the inner portion of the expandable tracheostomy tube.

[0012] FIG. 3A depicts the inner cannula of the expandable tracheostomy tube substantially inside the outer cannula.

[0013] FIG. 3B depicts the inner cannula of the expandable tracheostomy tube pushed outward from the outer cannula.

[0014] FIG. 4A depicts different sizes of inner cannula inside of the same outer cannula.

[0015] FIG. 4B depicts different sizes of inner cannula inside of the same outer cannula from a different perspective.

[0016] FIG. 4C depicts different sizes of inner cannula.

[0017] FIG. 4D depicts cutaway views of three different sizes of the inner cannula of the expandable tracheostomy tube substantially inside the same outer cannula.

[0018] FIG. 5 depicts a different shape of an inner cannula.DETAILED DESCRIPTION

[0019] In the following description of the various embodiments, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration various embodiments in which aspects of the disclosure may be practiced. It is to be understood that other embodiments may be utilized and structural and functional modifications may be made without departing from the scope of the present disclosure. Aspects of the disclosure are capable of other embodiments and of being practiced or being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein are for the purpose of description and should not be regarded as limiting. Rather, the phrases and terms used herein are to be given their broadest interpretation and meaning. The use of “including” and “comprising” and variations thereof is meant to encompass the items listed thereafter and equivalents thereof as well as additional items and equivalents thereof.

[0020] By way of introduction, while the inner diameter of a tracheostomy tube may dictate air flow into the patient's airway, the outer diameter may control the ability for exhaled air to escape past the tracheostomy tube and out the mouth / nose. The ability to pass air into009642.00052 the mouth / nose can be critical for safe swallow and speech. In turn, the sooner patient can be downsized (e.g., changed to a smaller tracheostomy tube outer diameter), the better the outcomes for safe swallow and speech. That said, conventionally, an initial tracheostomy tube must be removed in order to place a new, smaller tracheostomy tube. This removal process introduces significant risks adverse events. Because of this, most surgeons may wait five days on average prior to exchanging a tracheostomy tube to increase the likelihood that the tract through the skin and soft tissues retains its shape. This delay in tracheostomy tube exchange can itself introduce significant and potentially long-term adverse effects, such as dysphagia (difficulties swallowing), aspiration (fluids or solids falling into the airway), and aphonia / dysphonia (absent or poor speech). These also lead to significant downstream effects such as pneumonia from aspiration and depression from poor speech.

[0021] Described herein is an expandable tracheostomy tube that uses an elastic outer cannula and rigid inner cannula to allow customization of the intraluminal tracheostomy tube. The expandable tracheostomy tube may allow a surgeon to change the outer diameter of the first tracheostomy tube placed, eliminating the need to remove it. In turn, removal of an inner cannula from the outer cannula need not require removal of the outer cannula. In this context, expandable may refer to the ability to the first tracheostomy tube to deform, expand, and / or otherwise modify its shape relative to an original shape. This persistence of the first tracheostomy tube may reduce the risks related to tracheostomy tube exchange (most notably asphyxia) while also reducing the amount of time needed to change to a smaller outer diameter. In turn, use of such an expandable tracheostomy tube may provide to earlier improvements in swallow and speech.

[0022] Moreover, an expandable tracheostomy tube may also offer a potential for shapes the differ from a perfectly concentric tube. For example, the tube could be oblong, an oval, or a variety of other shapes. These shapes may help facilitate personalization of the tracheostomy tube, which is important for patients that require tracheostomy tubes for long term. Similarly, the ease of changing trach tube diameter size and shape and eliminating the need to exchange tracheostomy tubes may mean that patients can receive personalize care sooner with the help of a speech therapist, opposed to having to coordinate with a surgeon to exchange different trach sizes (and, of course, the inherent risks with such exchange). These benefits may be significantly impactful in the pediatric population.009642.00052

[0023] FIG. 1 depicts an outer cannula 100, which may comprise the outer portion of the expandable tracheostomy tube. The outer cannula 100 may be elastic and / or expandable. For example, the outer cannula might have a shore hardness of approximately 60a. In turn, the outer cannula 100 may be capable of expanding or contracting to account for a wide variety of different inner cannula. The outer cannula 100 may comprise standoffs, offsets, bumps, grooves, or similar elements configured to maintain some degree of space (e.g., an air gap) between the interior of the outer cannula 100 and the exterior of the inner cannula. Note that both cannula may comprise, but need not comprise, a cutting edge or other edge. While some cannula might comprise an edge (e.g., a sharp edge) for the purposes of insertion into a human body, aspects described herein need not have such an edge.

[0024] The outer cannula 100 may be configured to expand in various ways. The material of the outer cannula 100 may permit expansion. For example, the outer cannula 100 may be made from rubber, relatively flexible and thin plastic, or some other material which permits the outer cannula 100 to expand in various dimensions. Additionally and / or alternatively, the outer cannula 100 may comprise one or more open side walls (e.g., openings such as cuts, slits) that permit expansion. For example, the outer cannula 100 may be comprised of relatively less elastic material but may comprise slits that permit expansion of the diameter of the outer cannula 100 when an inner cannula is inserted. A combination of such approaches may be implemented as well. For example, the outer cannula 100 may be multi-layered with both a relatively flexible material (e.g., rubber, latex) without cuts or openings surrounded by a relatively less flexible material (e.g., plastic) with cuts or openings to permit expansion. Such a combination may be beneficial where, for example, the rigidity of the less flexible material is desired but where the properties of a contiguous outer cannula 100 are desired.

[0025] The outer cannula 100 may be configured such that it may be biased to remain in a first position / shape (e.g., substantially cylindrical) but may be configured to expand outwardly (e.g., into a spherical and / or otherwise bulging shape) to a second position / shape. For instance, and end of the outer cannula 100 may comprise three regions: a first region at the distal end of the outer cannula 100, a second region that can be expanded (e.g., by comprising one or more cuts, a different and more flexible material compared to other regions, or the like), and a third region. In such an example, by moving the first and third regions closer together (e.g., and shortening the distance between the two to thereby squeeze the second region), the second region may expand outwardly from the original diameter of the outer cannula 100. For009642.00052 instance, the first region and the second region may comprise arms, and modification of the spacing of those arms relative to the length of the outer cannula 100 may compress the length of the second region and thereby cause it to bulge outward relative to a diameter of the outer cannula 100 and thereby expand the diameter of the outer cannula 100 within the second region. In this manner, a portion of the material used to define the length of the outer cannula 100 may be compressed to expand a diameter of the outer cannula 100. To make such expansion more reliable and / or uniform across the radius of the outer cannula 100, various cuts, slits, and / or other openings may be defined. For example, lengthwise slits may be used such that, when compressed, portions of the outer cannula 100 uniformly expand.

[0026] Expansion of one or more portions of the outer cannula 100 may be based on various forms of motion. For example, when an inner cannula is inserted into the outer cannula 100, movement of the inner cannula (e.g., sliding it away from a distal end of the outer cannula 100) when the inner cannula is attached to a distal end of the outer cannula 100 may cause the distal end of the outer cannula 100 to move backwards and cause expansion (e.g., expansion of the diameter of) the outer cannula 100. In this way, for example, pulling of an inner cannula within the outer cannula 100 may cause a portion of the outer cannula 100 to expand outwardly.

[0027] FIG. 2 depicts an inner cannula 200, which may comprise the inner portion of the expandable tracheostomy tube. The inner cannula 200 may be rigid. For example, the inner cannula may have a shore hardness of approximately 80a to 90a. In this context, rigid need not mean totally immovable or fixed: rather, the rigidity of the inner cannula 200 may be relative to the flexibility of other portions described herein (e.g., the outer cannula 100). For example, the inner cannula 200 may be made of a stiff rubber, firm plastic, metal, or some other material which may maintain the shape of the inner cannula 200. In turn, the material of the inner cannula 200 may be firmer than the material of the outer cannula, such that insertion of the inner cannula 200 into the outer cannula 100 may cause the outer cannula to expand and / or contact as desired. With that said, in some instances, such as where the outer cannula 100 features openings (e.g., cuts, slits) that are configured to deform and / or expand based on the inner cannula 200, the outer cannula 100 and the inner cannula 200 may be made of the same or a substantially similar material.

[0028] FIG. 3A depicts the inner cannula 200 of the expandable tracheostomy tube substantially inside the outer cannula 100. In such an example, the outer cannula may be located towards a hole located through the skin and soft tissues of the anterior neck. As can be009642.00052 observed from the depiction in FIG. 3A, when fully inside the outer cannula 100, the inner canula 200 may stick out slightly, with a wider portion located at the distal end of the expandable tracheostomy tube.

[0029] FIG. 3B depicts the inner cannula 200 of the expandable tracheostomy tube pushed outward from the outer cannula 100. This depicts a circumstance where, for example, a care provider inserts the inner cannula 200 further into the trachea of a patient. In such an example, with respect to the patient, the outer cannula 100 may not move.

[0030] FIG. 4A depicts different sizes of inner cannula 200 inside of the same outer cannula 100. One advantage of the present expandable tracheostomy tube is that different inner cannula (e.g., inner cannula 200A, inner cannula 200B, inner cannula 200C, each of which may be of a different size, different material, or the like) may be inserted into the same outer cannula 100.

[0031] FIG. 4B depicts different sizes of inner cannula (e.g., the inner cannula 200A, the inner cannula 200B, and the inner cannula 200C) inside of the same outer cannula 100, albeit from a different perspective. This perspective is slightly rotated relative to the depictions in FIG. 4A.

[0032] FIG. 4C depicts how the inner cannula 200A, the inner cannula 200B, and the inner cannula 200C may be of different sizes, shapes, and / or made of different material. For example, the diameter of each of the inner cannula 200A, the inner cannula 200B, and / or the inner cannula 200C may be different. As another example, the material with which the inner cannula 200 A, the inner cannula 200B, and / or the inner cannula 200C are made may be different. As yet another example, the inner cannula 200A, the inner cannula 200B, and / or the inner cannula 200C may have different shapes: one may be substantially circular, another may be oblong, and the like.

[0033] FIG. 4D depicts cutaway views of the inner cannula 200A, the inner cannula 200B, and the inner cannula 200C substantially inside the outer cannula 100. In such a circumstance, each different inner cannula fits within the outer cannula 100 because the outer cannula 100 may be made of material that expands and / or otherwise accommodates the different sizes / shapes / configurations of the inner cannula.009642.00052

[0034] FIG. 5 depicts a different shape of an inner cannula 200D. In this example, the size, shape, material, and other properties of the inner cannula 200D may be personalized for a patient. For example, the shape and size of the inner cannula 200D may be selected to be smaller for a pediatric or physically smaller patient. As another example, an oval and / or oblong-shaped version of the inner cannula 200D may be used for patients with certain properties.

[0035] Although the subject matter has been described in language specific to structural features and / or methodological acts, it is to be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described above. Rather, the specific features and acts described above are disclosed as example forms of implementing the claims.

Claims

009642.00052CLAIMSWhat is claimed is:

1. An expandable tracheostomy tube comprising: an expandable outer cannula configured to expand to account for a variety of different inner cannula, wherein the expandable outer cannula is configured to permit a patient to exhale air; and a substantially rigid inner cannula configured for insertion through the expandable outer cannula and into a trachea of the patient, wherein the substantially rigid inner cannula is configured to permit airflow into an airway of the patient, and wherein the substantially rigid inner cannula is configured to be removed from the expandable outer cannula and replaced with a smaller substantially rigid inner cannula without requiring removal, from the patient, of the expandable outer cannula.

2. The expandable tracheostomy tube of claim 1, wherein the substantially rigid inner cannula is oval- shaped.

3. The expandable tracheostomy tube of claim 1, wherein the expandable outer cannula comprises one or more openings that permit a diameter of the expandable outer cannula to expand.

4. The expandable tracheostomy tube of claim 1, wherein the expandable outer cannula is made of a flexible material.

5. The expandable tracheostomy tube of claim 1, wherein a diameter of the outer cannula is configured for insertion into the trachea of the patient.

6. The expandable tracheostomy tube of claim 1, wherein the smaller substantially rigid inner cannula has a smaller diameter relative to the substantially rigid inner cannula.

7. The expandable tracheostomy tube of claim 1, wherein a material of the smaller substantially rigid inner cannula is different from a material of the substantially rigid inner cannula.009642.000528. The expandable tracheostomy tube of claim 1, wherein the substantially rigid inner cannula has a shore hardness that is at least 20a greater than the outer cannula.

9. A medical device comprising: an expandable outer cannula configured to expand to account for a variety of different inner cannula; and a substantially rigid inner cannula configured for insertion through the expandable outer cannula, wherein the substantially rigid inner cannula is configured to permit airflow, and wherein the substantially rigid inner cannula is configured to be removed from the expandable outer cannula and replaced with a smaller substantially rigid inner cannula without requiring modification of a location of the expandable outer cannula.

10. The medical device of claim 9, wherein the substantially rigid inner cannula is ovalshaped.

11. The medical device of claim 9, wherein the expandable outer cannula comprises one or more openings that permit a diameter of the expandable outer cannula to expand.

12. The medical device of claim 9, wherein the expandable outer cannula is made of a flexible material.

13. The medical device of claim 9, wherein a diameter of the outer cannula is configured for insertion into a trachea of a patient.

14. The medical device of claim 9, wherein the smaller substantially rigid inner cannula has a smaller diameter relative to the substantially rigid inner cannula.

15. The medical device of claim 9, wherein a material of the smaller substantially rigid inner cannula is different from a material of the substantially rigid inner cannula.

16. The medical device of claim 9, wherein the substantially rigid inner cannula has a shore hardness that is at least 20a greater than the outer cannula.009642.0005217. An expandable tracheostomy tube comprising: an expandable outer cannula configured to expand to account for a variety of different inner cannula, wherein the expandable outer cannula comprises one or more openings that permit a diameter of the expandable outer cannula to expand, and wherein the expandable outer cannula is made of a flexible material; and a substantially rigid inner cannula configured for insertion through the expandable outer cannula and into a trachea of a patient, wherein the substantially rigid inner cannula is configured to permit airflow into an airway of the patient, and wherein the substantially rigid inner cannula is configured to be removed from the expandable outer cannula and replaced with a smaller substantially rigid inner cannula without requiring removal, from the patient, of the expandable outer cannula.

18. The expandable tracheostomy tube of claim 17, wherein the substantially rigid inner cannula is oval- shaped.

19. The expandable tracheostomy tube of claim 17, wherein the smaller substantially rigid inner cannula has a smaller diameter relative to the substantially rigid inner cannula.

20. The expandable tracheostomy tube of claim 17, wherein a material of the smaller substantially rigid inner cannula is different from a material of the substantially rigid inner cannula.

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