Tracheal Tube Assembly

Abstract

A tracheostomy tube assembly is proposed. The assembly may include an outer cannula configured to be disposed within the airway. The assembly may also include an outer cannula connector coupled to a proximal end of the outer cannula, the outer cannula connector including a proximal region. The proximal region of the outer cannula connector may include a notch extending along the length of the outer cannula connector. The assembly may further include an inner cannula configured to be disposed within the outer cannula. The proximal region of the inner cannula may include gripping protrusions configured to be grasped by a user's fingers. The gripping protrusions may be at least partially received in and exposed by the notches of the outer cannula connector when the inner cannula is inserted into the outer cannula via the outer cannula connector.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application is a continuation of U.S. Patent Application No. 18 / 176,988, filed March 1, 2023, which was filed concurrently with U.S. Design Application entitled "INNER CANNULA FOR TRACHEAL TUBE ASSEMBLY" (Attorney Docket No. PASSY.042DA1) and U.S. Design Application entitled "TRACHEAL TUBE ASSEMBLY" (Attorney Docket No. PASSY.042DA2), the entire contents of each of which are incorporated herein by reference in their entirety.

[0002] The described technology generally relates to tracheal tube assemblies (hereinafter used interchangeably as "tracheostomy tube assemblies," "tracheostomy tube(s)," or "tracheal tube(s)"). [Background technology]

[0003] Tracheal tubes can be used to create an artificial airway that allows or controls the flow of air or other gases through a patient's trachea, or airway. Such tracheal tubes can also include tracheostomy tubes. Tracheostomy tubes are typically used for long-term ventilation because they are more comfortable for the patient. A typical tracheostomy tube is inserted into the trachea, generally through a surgical incision in the neck or percutaneously at the bedside. After the tube is inserted into the trachea, a portion of the tracheostomy tube remains outside the patient. Summary of the Invention

[0004] The embodiments disclosed herein each have several aspects, no single one of which is solely responsible for the desirable attributes of the present disclosure. Without limiting the scope of the present disclosure, some exemplary features and combinations are briefly described below. Upon review of this discussion, and particularly upon reading the "Detailed Description" section, one will understand how the features of the embodiments described herein provide advantages in connection with digital occlusion of tracheostomy tubes.

[0005] One aspect is a tracheostomy tube assembly that includes an inner cannula that can be easily detached from an outer cannula or an outer cannula connector (or hub).

[0006] Another aspect is a tracheostomy tube assembly including an outer cannula connector and an inner cannula that does not interfere with other devices connected to the outer cannula connector (e.g., speaking valves, heat and moisture exchangers, etc.), allowing the patient to occlude the tracheostomy tube with their fingers, with an inner cannula that can be easily removed or attached without applying excessive force to the outer cannula connector.

[0007] In a non-limiting example, the proximal region of the outer cannula connector may include one or more notches that facilitate insertion and removal of the inner cannula from the outer cannula connector.

[0008] In a non-limiting example, the outer cannula connector may include a tapered region that can facilitate manual removal and insertion of the inner cannula and prevent interference with devices connected to the outer cannula connector.

[0009] In a non-limiting example, the inner cannula may include one or more gripping protrusions that can facilitate grasping the proximal region through a notch in the outer cannula connector to compress the inner cannula in the area of ​​the notch prior to insertion and removal of the inner cannula. Additionally, insertion or removal of the inner cannula may be performed by hand in a manner that does not interfere with the outer cannula or outer cannula connector being attached to the patient.

[0010] In a non-limiting example, one or more gripping protrusions on the inner cannula can partially or completely fill a notch in the outer cannula connector, causing the outer cannula connector to become a uniform standard 15mm hub when the inner cannula is inserted.

[0011] In a non-limiting example, the proximal region of the inner cannula may be smaller in diameter than the widest portion of the outer cannula connector, but the face of the inner cannula is larger than the proximal end of the outer cannula connector. In this example, the outer cannula connector may form the connector portion for attachment to upstream medical tubing and / or devices, but the face of the inner cannula may be uninterrupted to allow for digital occlusion.

[0012] In a non-limiting example, the proximal region of the inner cannula, including the face of the inner cannula that rests in the gap of the ridge or lip at the more proximal end of the outer cannula, may be smaller in diameter than the widest portion of the outer cannula connector. In this example, the outer cannula connector may form a structure for attachment to upstream medical tubing and / or devices, while the inner cannula seals the cutout in the outer cannula connector while providing an uninterrupted surface on the front of the device to allow for finger occlusion.

[0013] These and other features of the present disclosure will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings, in which: The present disclosure will be described with additional specificity and detail using the accompanying drawings, with the understanding that these drawings depict only some embodiments in accordance with the present disclosure and are not to be considered as limiting the scope of the disclosure. [Brief explanation of the drawings]

[0014] [Figure 1] 1 shows an example of a tracheostomy tube assembly, a portion of which is inserted into a patient's trachea. [Figure 2A] FIG. 1 is a perspective view of an exemplary tracheostomy tube assembly with the inner cannula completely removed from the outer cannula and outer cannula connector. [Figure 2B] FIG. 2B is another perspective view of the exemplary tracheostomy tube assembly of FIG. 2A. [Figure 2C] FIG. 10 is a perspective view of another exemplary tracheostomy tube assembly with the inner cannula completely removed from the outer cannula and outer cannula connector. [Figure 2D] FIG. 2D is another perspective view of the exemplary tracheostomy tube assembly of FIG. 2C. [Figure 3A] FIG. 1 is a perspective view of an exemplary inner cannula. [Figure 3B] FIG. 3B is a side view of the exemplary inner cannula of FIG. 3A. [Figure 3C] FIG. 10 is a perspective view of another exemplary inner cannula. [Figure 3D] FIG. 3D is a side view of the exemplary inner cannula of FIG. 3C. [Figure 3E] FIG. 10 is a side view of another exemplary inner cannula. [Figure 3F] FIG. 10 is another side view of another exemplary inner cannula. [Figure 4A] FIG. 1 is a perspective view of an exemplary tracheostomy tube assembly with the inner cannula fully inserted into the outer cannula via the outer cannula connector. [Figure 4B]FIG. 4B is a side view of the exemplary tracheostomy tube assembly of FIG. 4A. [Figure 4C] FIG. 4B is an enlarged view of the outer cannula connector of the tracheostomy tube assembly of FIG. 4A. [Figure 4D] FIG. 4B is another side view of the tracheostomy tube assembly of FIG. 4A. [Figure 5A] FIG. 10 is a perspective view of another exemplary tracheostomy tube assembly, with the inner cannula fully inserted into the outer cannula via the outer cannula connector. [Figure 5B] FIG. 5B is a side view of the exemplary tracheostomy tube assembly of FIG. 5A. [Figure 5C] FIG. 10 is a side view of another tracheostomy tube assembly. [Figure 6A] FIG. 10 is a perspective view of another exemplary tracheostomy tube assembly, with the inner cannula fully inserted into the outer cannula via the outer cannula connector. [Figure 6B] FIG. 6B is a plan view of the tracheostomy tube assembly of FIG. 6A. [Figure 6C] FIG. 6B is a side view of the tracheostomy tube assembly of FIG. 6A. [Figure 7] 10 is a flowchart showing a procedure for inserting an inner cannula into an outer cannula via an outer cannula connector. [Figure 8] 10 is a flowchart illustrating a procedure for detaching the inner cannula from the outer cannula via the outer cannula connector. DETAILED DESCRIPTION OF THE INVENTION

[0015] In the following detailed description, reference is made to the accompanying drawings, which form a part of the detailed description. In the drawings, like symbols generally refer to like components unless the context dictates otherwise. Thus, in some embodiments, part numbers may be used for like components in multiple figures or the part numbers may vary from figure to figure. The illustrative embodiments described in the detailed description, drawings, and claims are not meant to be limiting. Some embodiments may be utilized, and other changes may be made, without departing from the spirit or scope of the subject matter presented herein. It will be readily understood that aspects of the present disclosure, as generally described herein and illustrated in the figures, can be arranged, substituted, combined, and designed in a wide variety of configurations, all of which are expressly considered and made a part of this disclosure.

[0016] References herein to "one embodiment," "an embodiment," or "in some embodiments" mean that a particular feature, structure, or characteristic described in connection with an embodiment is included in at least one embodiment of the present invention. Moreover, appearances of these or similar phrases throughout this specification do not necessarily all refer to the same embodiment, nor are separate or alternative embodiments necessarily mutually exclusive. Various features are described herein that may be present in some embodiments but not in other embodiments. Similarly, various requirements are described that may be required in some embodiments but not in other embodiments. <Summary>

[0017] A tracheostomy tube is an artificial airway inserted into a patient's trachea, allowing more direct access to mechanical and non-mechanical ventilation. A tracheostomy tube assembly typically includes an outer cannula configured to be positioned in the patient's airway, a flange member (or "neck plate") secured around the outer cannula, an outer cannula connector (or "hub") coupled to the proximal end of the outer cannula, and an inner cannula positioned inside the outer cannula and outer cannula connector. The inner cannula is removed for cleaning or replacement, for example, when secretions or other contaminants accumulate. Furthermore, if the inner cannula becomes completely or partially blocked by secretions, the patient may be unable to breathe through the inner cannula. Therefore, it is important that the inner cannula be easily removed without obstructing the outer cannula and the patient's airway.

[0018] One problem that arises with tracheostomy tubes with inner cannulas is the need to remove the inner cannula without disturbing the outer cannula or interfering with the placement of the tracheostomy tube in the patient. Excessive force on the tracheostomy tube, such as twisting or pulling, can result in dislodgement of the tracheostomy tube, patient discomfort, damage to the tissue surrounding the tracheostomy tube, or damage to the patient's airway.

[0019] Some patients who are not mechanically ventilated and cannot tolerate a speaking valve communicate by occluding the tracheostomy tube with their fingers. Occluding the tube with their fingers directs the patient's exhaled air into the upper airway, vocal cords, mouth, and nose, restoring communication. A problem encountered with some tracheostomy tubes with inner cannulas is that the face (or face portions) of the inner cannula may be shaped in a way that makes it impossible or difficult to occlude the tracheostomy tube with their fingers. For example, some designs have two tabs protruding from the face of the inner cannula that are compressed to remove the inner cannula (see, e.g., Figure 8 of U.S. Pat. No. 11,007,336). While these designs allow for easy cannula removal, the tabs prevent the fingers from sealing the inner cannula and allowing full airflow to the upper airway.

[0020] Therefore, there is a need for an improved tracheostomy tube, particularly one that allows for easy placement and removal of the inner cannula, does not interfere with other devices connected to the hub, and / or allows the patient to occlude the tracheostomy tube with their fingers.

[0021] FIG. 1 illustrates an exemplary tracheostomy tube assembly 100, a portion of which is inserted into the trachea 210 of a patient 200. The tracheostomy tube assembly 100 illustrated in FIG. 1 is exemplary only, and the present disclosure is not limited thereto. For example, the dimensions of the elements of the tracheostomy tube assembly 100 illustrated in FIG. 1 are exemplary only, and other dimensions are possible. Furthermore, the shapes of the elements of the tracheostomy tube assembly 100 are exemplary only, and other shapes are possible. Furthermore, some elements are optional and may be deleted, and / or other elements may be added to the exemplary tracheostomy tube assembly 100.

[0022] In the illustrated example, the tracheostomy tube assembly 100 includes an outer cannula 110, a flange 120, an outer cannula connector 130, and an inner cannula 140. The outer cannula 110 can be inserted into the trachea 210 of the patient 200 through a surgical incision or “stoma” in the patient's neck. The outer cannula 110 can house a cranial or proximal region of the inner cannula 140 therein. The outer cannula 110 can at least partially protect the inner cannula 140 from various bodily secretions of the patient when the tracheostomy tube assembly 100 is positioned inside the patient. The tracheostomy tube assembly 100 may also include a pilot balloon 160 and a cuff 114 attached to the outer cannula 110 (a “cuffed design”). The pilot balloon 160 can be used to inflate the cuff 114 to hold the outer cannula 110 in place within the trachea 210. The pilot balloon 160 inflates with the cuff 114 and may serve to indicate the air pressure within the cuff 114. The pilot balloon 160 may be used to inflate the cuff 114. The tracheostomy tube assembly 100 may not include the pilot balloon 160 and the cuff 114 (a "cuffless design"). That is, the pilot balloon 160 and the cuff 114 may be optional elements.

[0023] Inner cannula 140 may be inserted into outer cannula 110 via outer cannula connector 130. Inner cannula 140 includes an opening 170 (not shown in FIG. 1 , see FIG. 3C ) for controlling the flow of air or other gases through the patient's trachea 210. Patient 200 can place their finger over opening 170 to block the flow of air from outside into the patient's trachea (referred to as a "finger occlusion," although it will be understood that this term also includes occlusion devices other than a finger). The patient or user (e.g., a caregiver or healthcare professional) can remove their finger from opening 170 to unblock the airflow into the patient's trachea 210.

[0024] In some embodiments, inner cannula 140 may include one or more gripping protrusions (described in more detail below) to facilitate insertion into and removal from outer cannula connector 130. For example, patient 200 may grasp one or more gripping protrusions with their fingers when removing and / or inserting inner cannula 140 into outer cannula connector 130. Inner cannula 140 may be removed from outer cannula 110 for cleaning, replacement, or other reasons. In some embodiments, inner cannula 140 may include one or more mating protrusions (described in more detail below) on its outer wall that easily and / or smoothly engage with outer cannula connector 130 with some friction and that engage with one or more mating recesses or one or more mating protrusions (described in more detail below) formed on the inner wall of outer cannula connector 130 for removal from outer cannula connector 130.

[0025] Flange 120 can support outer cannula 110 and outer cannula connector 130. For example, outer cannula connector 130 may extend from the front of flange 120. When outer cannula 110 is positioned within trachea 210 of patient 200, the rear of flange 120 may be positioned against the patient's neck.

[0026] Outer cannula connector 130 receives inner cannula 140 such that inner cannula 140 is inserted into outer cannula 110. The inner diameter of outer cannula connector 130 may be approximately the same as or slightly larger than the outer diameter of the largest portion of inner cannula 140 such that the front (or head) of inner cannula 140 is inserted into outer cannula connector 130. Outer cannula connector 130 may be constructed of a different material than inner cannula 140. For example, inner cannula 140 may be constructed of a flexible material, while outer cannula connector 130 is constructed of a hard material such as plastic. Outer cannula connector 130 may be used by the patient to hold outer cannula connector 130 (in addition to or instead of holding flange 120) when inner cannula 140 is inserted into or removed from outer cannula connector 130.

[0027] In some embodiments, outer cannula connector 130 may include one or more notches (described in more detail below) configured to expose one or more gripping protrusions of inner cannula 140 when inner cannula 140 is fully inserted into outer cannula 110 through outer cannula connector 130. As disclosed herein, "the inner cannula is fully inserted into the outer cannula" means that the inner cannula is properly attached to the outer cannula by fully inserting a portion (e.g., the body) of the inner cannula into the outer cannula through the outer cannula connector. This does not mean that the entire inner cannula is positioned completely within the outer cannula, but may generally mean that the body of the inner cannula is inserted into the outer cannula and the head of the inner cannula is inserted into the outer cannula connector. In some embodiments, each of the inner cannula 140 or outer cannula connector 130 may include at least one of 1) one or more mating protrusions or 2) one or more mating recesses for smooth engagement and disengagement with each other with some friction. <Tracheostomy tube assembly (with inner cannula removed)>

[0028] Figure 2A is a perspective view of an exemplary tracheostomy tube assembly 100a with the inner cannula 140 completely removed from the outer cannula 110 and the outer cannula connector 130. Figure 2B is another perspective view of the exemplary tracheostomy tube assembly 100a. The exemplary tracheostomy tube assembly 100a may be substantially identical to or similar to the tracheostomy tube assembly 100 of Figure 1.

[0029] The outer cannula connector 130 may include a distal region 122 coupled to the flange 120 and a proximal region 124 opposite the distal region 122. As disclosed herein, the proximal region or proximal end may refer to a region closer to a user of the tracheostomy tube assembly 100 than the distal region or distal end. The outer cannula connector 130 may include one or more notches 132 extending longitudinally of the outer cannula connector 130. The one or more notches 132 may be disposed or formed in the proximal region 124 of the outer cannula connector 130. The one or more notches 132 may be configured to expose one or more gripping protrusions 148 formed on the proximal region (or head) 144 of the inner cannula 140 when the inner cannula 140 is fully inserted into the outer cannula 110. At least one of the one or more notches 132 may be sized to fully expose the one or more gripping protrusions 148 when inner cannula 140 is fully inserted into outer cannula 110. In the illustrated example, outer cannula connector 130 includes two notches 132. However, the present disclosure is not limited in this respect. For example, a single notch, or three or more notches, may be provided in proximal region 124 of outer cannula connector 130.

[0030] 2B, each of the one or more notches 132 includes an opening distance (L) and a depth (W). The opening distance (L) may be between about 8 mm and about 15 mm (e.g., about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, and ranges between these values). For example, the opening distance (L) may be between about 10 mm and about 12 mm.

[0031] The depth (W) may be between about 1 mm and about 8 mm (e.g., about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, and ranges between these values). For example, the depth (W) may be between about 3 mm and about 6 mm.

[0032] Outer cannula connector 130 may further include ridge 134. Ridge 134 may be adjacent to one or more notches 132. Ridge 134 may be configured such that the outer end of proximal region 144 of inner cannula 140 (or the surface shown in FIG. 3A, 3C, 3E, or 3F) rests on ridge 134. Ridge 134 may be tapered. For example, ridge 134 may gradually thin from proximal region 124 to distal region 122 of outer cannula connector 130. In some embodiments, ridge 134 may have a diameter of approximately 15 mm or less to comply with current ISO standards (e.g., ISO Standard 5366). Outer cannula connector 130 may be tapered from proximal region 124 to distal region 122. In a non-limiting example, the diameter of the largest portion of outer cannula connector 130 may be approximately 15 mm or less to comply with current ISO standards.

[0033] Outer cannula connector 130 may include one or more mating features on its inner wall configured to connect with one or more mating features on the outer wall of inner cannula 140. In a non-limiting example, outer cannula connector 130 may include one or more mating recesses 136 formed on its inner wall. One or more mating recesses 136 may engage with one or more mating protrusions formed on the outer wall of inner cannula 140 when inner cannula 140 is inserted into outer cannula 110 via outer cannula connector 130. For example, one or more mating recesses 136 may be sized to respectively receive one or more mating protrusions of inner cannula 140 when inner cannula 140 is inserted into outer cannula 110. One or more mating recesses 136 may include one or more first mating recesses 136 and one or more second mating recesses (not shown in FIG. 2A ). The one or more second mating recesses may be disposed opposite the one or more first mating recesses 136. The number of mating recesses described above is merely exemplary, and the present disclosure is not limited thereto. For example, the one or more first recesses 136 may include three or more sets of mating recesses, each set including one or more mating recesses.

[0034] In some embodiments, in addition to or instead of one or more mating recesses 136, outer cannula connector 130 may include one or more mating protrusions configured to engage with two or more mating protrusions on inner cannula 140. In other words, inner cannula 140 may include one or more mating protrusions 146 for each mating protrusion on outer cannula connector 130. In a non-limiting example, inner cannula 140 includes two mating protrusions 146 arranged parallel to one another along the length of proximal region 144. As shown in FIG. 3A , inner cannula 140 may include multiple sets of these mating protrusions 146 circumferentially spaced from one another around proximal region 144. Outer cannula connector 130 may include one mating protrusion configured to be disposed between two mating protrusions 146 of inner cannula 140 such that one mating protrusion of outer cannula connector 130 is latched (secured) between two mating protrusions 146 of inner cannula 140. In another non-limiting example, if inner cannula 140 includes three mating protrusions, outer cannula connector 130 may include two mating protrusions configured to be disposed between three mating protrusions of inner cannula 140 such that two mating protrusions of outer cannula connector 130 are latched between three mating protrusions of inner cannula 140. In some embodiments, when the two mating protrusions of outer cannula connector 130 include first and second mating protrusions and the three mating protrusions of inner cannula 140 include first, second, and third mating protrusions, the first mating protrusion of outer cannula connector 130 may be latched between the first and second mating protrusions of inner cannula 140. Similarly, the second mating protrusion of outer cannula connector 130 may be latched between the second and third mating protrusions of inner cannula 140.

[0035] In some embodiments, outer cannula connector 130 may include one or more mating protrusions instead of one or more mating recesses. In these embodiments, inner cannula 140 may include one or more mating recesses. One or more mating protrusions of outer cannula connector 130 may engage with one or more mating recesses of inner cannula 140. In the above embodiments, outer cannula connector 130 may include one or more mating protrusions in the same number as the number of one or more mating recesses of inner cannula 140.

[0036] In some embodiments, neither outer cannula connector 130 nor inner cannula may include one or more mating protrusions or recesses. In these embodiments, the outer diameter of inner cannula 140 may be slightly larger than examples of inner cannulas that include one or more mating protrusions to provide some friction against the inner wall of outer cannula connector 130.

[0037] In the illustrated example, one or more mating recesses 136 of outer cannula connector 130 are positioned so as not to overlap ridges 134 in the longitudinal direction of outer cannula connector 130. However, the present disclosure is not limited in this respect. For example, one or more mating recesses 136 and / or one or more additional mating protrusions or mating recesses may be positioned so as to overlap ridges 134 in the longitudinal direction of outer cannula connector 130.

[0038] Each of the one or more mating recesses 136 has a length (L mr ), width (W mr ), and height or depth (H mr ) including (L mr , W mr , and H mr (not shown in the drawing). Length (L mr ) can be between about 1 mm and about 8 mm (e.g., about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, and ranges between these values). For example, the length (L mr The width (W) may be between about 3 mm and 5 mm. mr) can be between about 0.5 mm and about 4 mm (e.g., about 0.5 mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, and ranges between these values). For example, the width (W mr The height (H) may be between about 1 mm and 2.5 mm. mr ) may be between about 0.5 mm and about 3.5 mm (e.g., about 0.5 mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, and ranges between these values). For example, the height (H mr ) may be between about 1 mm and 2 mm. If outer cannula connector 130 includes one or more mating protrusions, the dimensions of at least one of the one or more mating protrusions of outer cannula connector 130 may be the same as the dimensions of one or more mating recesses 136 described above.

[0039] Inner cannula 140 may include a head or proximal region 144 and a body 142. At least a portion of the body may be referred to as the distal region. At least a portion of proximal region 144 may be exposed by outer cannula connector 130 when inserted into outer cannula 110 through connector opening 180 (see FIG. 2A ) of outer cannula connector 130. In some embodiments, body 142 of inner cannula 140 may have a length that allows it to be completely contained within outer cannula 110 such that no portion of body 142 protrudes beyond inner end 112 of outer cannula 110. In some embodiments, body 142 of inner cannula 140 may have a length that allows it to protrude beyond inner end 112 of outer cannula 110. Proximal region 144 may be larger in diameter or width than body 142 so that body 142 can be easily inserted into outer cannula 110 while proximal region 144 can engage the inner wall of outer cannula connector 130.

[0040] In some embodiments, inner cannula 140 may include one or more gripping protrusions 148 that allow a patient or user to grasp the inner cannula 140 with their fingers when removing it from and / or inserting it into outer cannula connector 130. The one or more gripping protrusions 148 may be fully exposed by one or more notches 132 when inner cannula 140 is fully inserted into outer cannula 110. At least one of the one or more gripping protrusions 148 may be tapered toward body 142. In a non-limiting example, the diameter of the largest portion of inner cannula 140 may be approximately 15 mm or less to comply with current ISO standards. This may facilitate manual removal and insertion of inner cannula 140 while preventing interference with various devices (e.g., speaking valves, occlusion adapters, etc.) that may be connected to outer cannula connector 130.

[0041] In the illustrated example, inner cannula 140 includes two sets of single grip protrusions 148 (see FIGS. 2A and 2B ) located on opposite sides of proximal region 144 of inner cannula 140. However, the present disclosure is not limited thereto. In a non-limiting example, each set of grip protrusions may include two or more grip protrusions. In these embodiments, the two or more grip protrusions may be sized to fully receive within notch 132 of outer cannula connector 130. In another non-limiting example, the sets of grip protrusions may include different numbers of grip protrusions. For example, one set of grip protrusions may include two or more grip protrusions, while another set of grip protrusions may include a single grip protrusion, or three or more grip protrusions. In these embodiments, the two or more grip protrusions, or the three or more grip protrusions, may be sized to fully receive within notch 132 of outer cannula connector 130. In some embodiments, each set of grip protrusions may include at least one grip protrusion having a different size from the other grip protrusions of the other set of grip protrusions. As shown, inner cannula 140a includes a pair of gripping protrusions 148 that project radially outward from the body of proximal region 144. A pair of gripping protrusions 150 are disposed opposite one another. Grip protrusions 150 may project radially outward relative to mating protrusions 146. Grip protrusions 150 may extend a greater distance around the circumference of proximal region 144 than mating protrusions 146. Each gripping protrusion 150 extends from face 154 of inner cannula 140. Each gripping portion 150 may be arcuate.

[0042] Each of the one or more gripping protrusions 148 has a length (L gp ), width (W gp ), and height (H gp ) including (L gp , W gp , and H gp (not shown in the drawing). Length (L gp ) can be between about 4 mm and about 10 mm (e.g., about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, and ranges between these values). For example, the length (Lgp The width (W) may be between about 6.5 mm and about 8 mm. gp ) can be between about 0.5 mm and about 4 mm (e.g., about 0.5 mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, and ranges between these values). For example, the width (W gp The height (H) may be between about 1 mm and about 2.5 mm. gp ) may be between about 0.5 mm and about 3.5 mm (e.g., about 0.5 mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, and ranges between these values). For example, the height (H gp ) may be between about 1 mm and about 2 mm.

[0043] In some embodiments, inner cannula 140 may include one or more mating protrusions 146 formed on the outer wall of proximal region 144. In some embodiments, one or more mating protrusions 146 can engage with one or more mating recesses 136 formed on the inner wall of outer cannula connector 130. One or more mating protrusions 146 can engage with one or more mating protrusions formed on the inner wall of outer cannula connector 130.

[0044] In some embodiments in which outer cannula connector 130 may include one or more mating protrusions, inner cannula 140 may include one or more mating recesses configured to engage with one or more mating protrusions of outer cannula connector 130.

[0045] In some embodiments in which outer cannula connector 130 may include one or more mating protrusions and one or more mating recesses, inner cannula 140 may include one or more mating recesses configured to engage with one or more mating protrusions of outer cannula connector 130, and one or more mating protrusions configured to engage with one or more mating recesses of outer cannula connector 130.

[0046] Each of the one or more mating projections 146 has a length (L mp ), width (W mp ), and height (Hmp ) including (L mp , W mp , and H mp (not shown in the drawing). Length (L mp ) can be between about 1 mm and about 8 mm (e.g., about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, and ranges between these values). For example, the length (L mp The width (W) may be between about 3 mm and 5 mm. mp ) can be between about 0.5 mm and about 4 mm (e.g., about 0.5 mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, and ranges between these values). For example, the width (W mp The height (H) may be between about 1 mm and 2.5 mm. mp ) may be between about 0.5 mm and about 3.5 mm (e.g., about 0.5 mm, about 1 mm, about 1.5 mm, about 2 mm, about 2.5 mm, about 3 mm, about 3.5 mm, and ranges between these values). For example, the height (H mp ) may be between about 1 mm and 2 mm.

[0047] The above dimensions of the notch 132, mating recess (and / or mating protrusion) 136, gripping protrusion 148, and mating protrusion (and / or mating recess) 146 are merely exemplary, and the present disclosure is not limited thereto. In some embodiments, at least one dimension of the mating protrusion, mating recess, or gripping protrusion may be larger or smaller than the ranges described above. For example, each dimension described above may be larger or smaller than the corresponding dimension by about 0.5%, about 1%, about 5%, about 10%, about 20%, about 30%, about 40%, about 50%, or any number therebetween. When a dimension of one element is made smaller or larger, the dimensions of the other elements are made proportionally smaller or larger.

[0048] Inner cannula 140 may be manufactured from a variety of materials, including, but not limited to, polytetrafluoroethylene (PTFE), low-density polyethylene (LDPE), high-density polyethylene (HDPE), polyvinyl chloride (PVC), or polymethylpentene (PMP). Outer cannula connector 130 may be manufactured from a variety of materials, including, but not limited to, polytetrafluoroethylene (PTFE), low-density polyethylene (LDPE), high-density polyethylene (HDPE), polyvinyl chloride (PVC), polymethylpentene (PMP), or silicone rubber. Outer cannula 110 may be manufactured from a variety of materials, including, but not limited to, polytetrafluoroethylene (PTFE), low-density polyethylene (LDPE), high-density polyethylene (HDPE), polyvinyl chloride (PVC), polymethylpentene (PMP), or silicone rubber.

[0049] Mating recesses 136 or mating protrusions of outer cannula connector 130 may be formed using the same manufacturing process (e.g., molding) as outer cannula connector 130. For example, mating recesses 136 or mating protrusions of outer cannula connector 130 may be integrally formed with the remainder of outer cannula connector 130. Mating protrusions 146 of inner cannula 140 may be formed using the same manufacturing process (e.g., molding) as inner cannula 140. For example, mating protrusions 146 or mating recesses of inner cannula 140 may be integrally formed with the remainder of inner cannula 140. Grip protrusions 148 of inner cannula 140 may be formed using the same manufacturing process (e.g., molding) as inner cannula 140. For example, grip protrusions 148 may be integrally formed with the remainder of the proximal region of inner cannula 140.

[0050] Figure 2C is a perspective view of another exemplary tracheostomy tube assembly 100b in which the inner cannula 140 is completely removed from the outer cannula 110 and the outer cannula connector 130. Figure 2D is another perspective view of the exemplary tracheostomy tube assembly 100b of Figure 2C. The exemplary tracheostomy tube assembly 100b of Figures 2C and 2D is substantially identical to or similar to the exemplary tracheostomy tube assembly 100a of Figures 2A and 2B, except that in the exemplary tracheostomy tube assembly 100b of Figures 2C and 2D, the inner cannula 140 may include gripping protrusions 150 that are larger than the gripping protrusions 148 of the exemplary tracheostomy tube assembly 100a of Figures 2A and 2B. The gripping protrusions 150 may be substantially fully received in the notches 132 of the outer cannula connector 130. For example, gripping projections 150 may have the same, substantially the same, or similar dimensions as notch 132 of outer cannula connector 130. In these embodiments, gripping projections 150 may be completely or substantially completely received within notch 132. Grip projections 150 may be flush or substantially flush with the outer wall of outer cannula connector 130 adjacent gripping projections 150 when inner cannula 140 is fully inserted into outer cannula 110. In some embodiments, gripping projections 150 may be lower than the outer wall of outer cannula connector 130. In some embodiments, the dimensions of gripping projections 150 may be slightly smaller than the dimensions of notch 132. In these embodiments, gripping projections 150 may be completely received within notch 132. Grip projections 150 may be formed by the same manufacturing process (e.g., molding) used to manufacture inner cannula 140. For example, gripping projections 150 may be integrally formed with the remainder of the proximal region of inner cannula 140. At least one of the one or more gripping projections 150 may be tapered in a direction toward the body 142. In a non-limiting example, the diameter of the largest portion of the inner cannula 140 (e.g., the gripping projection 150) may be approximately 15 mm or less to comply with current ISO standards.This allows inner cannula 140 to be easily removed and inserted by hand while preventing interference with various devices that can be connected to outer cannula connector 130. <Inner cannula>

[0051] Figure 3A is a perspective view of an exemplary inner cannula 140a. Figure 3B is a side view of the exemplary inner cannula 140a of Figure 3A. The exemplary inner cannula 140a may be substantially the same as or similar to the inner cannula 140 of Figure 1.

[0052] Inner cannula 140a can be used with tracheostomy tube assembly 100a shown in Figures 2A and 2B. Inner cannula 140a may include a head or proximal region 144 and a body 142. Proximal region 144 may include one or more gripping protrusions 148, one or more sets of mating protrusions 146, and a face 154. At least one of gripping protrusions 148, mating protrusions 146, or face 154 may be integrally formed with proximal region 144 or the remainder of inner cannula 140.

[0053] In the illustrated example, the proximal region 144 includes two grip protrusions 148. The two grip protrusions 148 may be located on opposite sides of the proximal region 144. However, the present disclosure is not limited thereto. For example, the proximal region 144 may include one grip protrusion, or three or more grip protrusions located at different locations on the proximal region 144. As another example, each set of grip protrusions may include two or more grip protrusions located at two or more locations on the proximal region 144. As another example, one set of grip protrusions may include a single grip protrusion, and another set of grip protrusions may include two or more grip protrusions.

[0054] At least one of gripping protrusions 148 may be flush with the outer surface of outer cannula connector 130 adjacent to gripping protrusion 148 when inner cannula 140 is fully inserted into outer cannula 110. However, the present disclosure is not limited in this respect. For example, at least one of gripping protrusions 148 may not be flush with the outer surface of outer cannula connector 130 adjacent to gripping protrusion 148 when inner cannula 140 is fully inserted into outer cannula 110. In this example, at least one of gripping protrusions 148 may be shorter in height than the outer surface of outer cannula connector 130 when inner cannula 140 is fully inserted into outer cannula 110.

[0055] At least one of the one or more gripping protrusions 148 may be tapered in a direction toward body 142. In a non-limiting example, the diameter of the largest portion of inner cannula 140a (e.g., gripping protrusion 148) may be approximately 15 mm or less to comply with current ISO standards. This allows for easy manual removal and insertion of inner cannula 140 while preventing interference with various devices that may be connected to outer cannula connector 130.

[0056] Proximal region 144 may include an opening 158 for a user to occlude tracheostomy tube assembly 100a with a finger or with an occlusion adapter, which may be configured to cover opening 158 and a portion of proximal region 144. Opening 158 may be sized to be completely covered by an average adult's finger.

[0057] In some embodiments, proximal region 144 may taper in a direction toward body 142. In some embodiments, proximal region 144 may not be tapered. In these examples, the outer diameter of proximal region 144 may not be greater than 15 mm in accordance with current ISO standards so that the proximal region can fit into outer cannula connector 130. Face 154 may be larger in diameter than the outer diameter of outer cannula connector 130 so that a user can grip face 154 when inserting into and removing from outer cannula connector 130. In a non-limiting example, the diameter of face 154 may be 15 mm or less to comply with current ISO standards.

[0058] FIG. 3C is a perspective view of another exemplary inner cannula 140b. FIG. 3D is a side view of the exemplary inner cannula 140b of FIG. 3C. The exemplary inner cannula 140b of FIGS. 3C and 3D is substantially identical to the exemplary inner cannula 140a of FIGS. 3A and 3B, except that the exemplary inner cannula 140b of FIGS. 3C and 3D includes gripping protrusions 150 that are larger than the gripping protrusions 148 shown in FIGS. 3A and 3B. In some embodiments, the gripping protrusions 150 may have the same or substantially the same dimensions as the dimensions of the notch 132 of the outer cannula connector 130. In these embodiments, the gripping protrusions 150 may be fully or substantially fully received in the notch 132 when the inner cannula 130 is inserted into the outer cannula 110. As shown, the inner cannula 140b includes a pair of gripping protrusions 150 that protrude radially outward from the body of the proximal region 144. The pair of gripping protrusions 150 are disposed opposite each other. The gripping protrusions 150 may project radially outward relative to the mating protrusions 146. Each gripping protrusion 150 extends from a surface 154 of the inner cannula 140. Each gripping portion 150 may be semicircular.

[0059] In a non-limiting example, gripping protrusions 150 may be flush or nearly flush with the portion of outer cannula connector 130 adjacent notch 132 when inner cannula 140 is fully inserted into outer cannula 110. In another non-limiting example, gripping protrusions 150 may not be flush with the portion of outer cannula connector 130 adjacent notch 132 when inner cannula 140 is fully inserted into outer cannula 110. In this example, gripping protrusions 150 may be shorter in height than the portion of outer cannula connector 130 adjacent notch 132 when inner cannula 140 is fully inserted into outer cannula 110. In some embodiments, the dimensions of gripping protrusions 150 may be slightly smaller than the dimensions of notch 132. In these embodiments, gripping protrusions 150 may be fully received within notch 132. In the example shown in Figures 3A to 3D, the user can grasp at least one of the grip protrusions (148 / 150) or the surface portion 154 when inserting the inner cannula 140 into the outer cannula 110 or when removing the inner cannula 140 from the outer cannula 110.

[0060] Figure 3E is a side view of another exemplary inner cannula 140c. The exemplary inner cannula 140c of Figure 3E is substantially the same as or similar to the exemplary inner cannula 140a of Figures 3A and 3B, except that the exemplary inner cannula 140c of Figure 3E does not include gripping protrusions. In some embodiments, the outer cannula connector 130 may not include a notch.

[0061] Inner cannula 140c may include face 154. Face 154 may be exposed by outer cannula connector 130 when inner cannula 140c is inserted into outer cannula 110. As described above, face 154 may have a larger diameter than at least a portion of outer cannula connector 130 immediately adjacent face 154 when inner cannula 140 is inserted into outer cannula 110. Face 154 may thus provide a user with a grip when inserting or removing inner cannula 140c from outer cannula 110, even if proximal region 144 of inner cannula 140 does not include gripping protrusions (e.g., 148 or 150).

[0062] In some embodiments, surface 154 may be manufactured in the same manufacturing process as inner cannula 140c. In a non-limiting example, inner cannula 140c may be manufactured by a molding process, and surface 154 may be manufactured by the same molding process. Surface 154 may be integrally formed with proximal region 144 of inner cannula 140c.

[0063] Figure 3F is a side view of another exemplary inner cannula 140d. Exemplary inner cannula 140d in Figure 3F is substantially the same as or similar to exemplary inner cannula 140c in Figure 3E, except that exemplary inner cannula 140d in Figure 3F includes larger surface 156 compared to smaller surface 154 of exemplary inner cannula 140c in Figure 3E. As in Figure 3E, in this example, outer cannula connector 130 may not include a notch.

[0064] In a non-limiting example, face 156 may have a diameter of 15 mm or less to comply with current ISO standards. In this example, due to the larger face 156, the outer diameter of proximal region 144 of inner cannula 140d shown in FIG. 3F may be smaller than the outer diameter of proximal region 144 of inner cannula 140c in FIG. 3E.

[0065] In a non-limiting example, surface portion 1556 may be about 5% to about 20% larger than surface portion 154. Surface portion 156 may be exposed by outer cannula connector 130 when inner cannula 140d is inserted into outer cannula 110. In this example, surface portion 156 may be grippable by the user when inserting inner cannula 140d into outer cannula 110 or when removing inner cannula 140d from outer cannula 110.

[0066] Like face portion 154, face portion 156 may be manufactured in the same manufacturing process as inner cannula 140d. In a non-limiting example, inner cannula 140d may be manufactured in a molding process, and face portion 156 may be manufactured in the same molding process. Face portion 156 may be integrally formed with proximal region 144 of inner cannula 140d. Face portion 156 may be made of the same material as the rest of inner cannula 140d, including the material of proximal region 144. <Tracheostomy tube assembly (with inner cannula inserted)>

[0067] Figure 4A is a perspective view of an exemplary tracheostomy tube assembly 100c with an inner cannula (not shown in Figure 4A) fully inserted into the outer cannula 110 via the outer cannula connector 130. Figure 4B is a side view of the exemplary tracheostomy tube assembly 100c of Figure 4A. Figure 4C is an enlarged view of the outer cannula connector 130 of the tracheostomy tube assembly 100c of Figure 4A. Figure 4D is another side view of the tracheostomy tube assembly 100c of Figure 4A. The exemplary tracheostomy tube assembly 100c of Figure 4A may be substantially identical to or similar to the exemplary tracheostomy tube assembly 100a of Figure 2A.

[0068] 4A, 4C, and 4D, grip protrusions 148 are exposed by notches 132 when the inner cannula is fully inserted into outer cannula 110 through outer cannula connector 130, allowing the user to easily hold grip protrusions 148 when attempting to remove or insert the inner cannula from or into outer cannula 110.

[0069] In some embodiments, as shown in FIG. 4B , mating projections 146 of the inner cannula engage mating recesses or projections of the outer cannula connector 130. In the illustrated example, the mating projections / recesses are positioned to be aligned with the gripping projections 148 in the longitudinal direction of the outer cannula connector 130. However, the present disclosure is not limited thereto. For example, in addition to or instead of the mating projections 146 (or recesses), additional mating projections and / or recesses may be formed at other positions that do not overlap with the gripping projections in the longitudinal direction. The proximal region 144 of the inner cannula may taper toward the flange 120. For example, the width or diameter of the proximal region may gradually decrease from the left end toward the right end, which is closer to the flange 120 than the left end. This tapered structure may facilitate easier insertion or removal of the inner cannula 140 into or from the outer cannula connector 130 due to reduced friction between the tapered outer wall of the inner cannula and the inner wall of the outer cannula connector 130.

[0070] In some embodiments, the outer wall of the proximal region 144 of the inner cannula may not be tapered. In these embodiments, the inner wall of the outer cannula connector 130 may taper in the opposite direction (i.e., the inner wall widens from the left end to the right end). In some embodiments, the outer wall of the proximal region 144 of the inner cannula may taper in one direction, and the inner wall of the outer cannula connector 130 may taper in the opposite direction. In the above embodiments in which at least one of the outer wall of the proximal region 144 or the inner wall of the outer cannula connector 130 is tapered, the first portion 162 of the outer cannula connector 130 may contact the outer wall of the proximal region 144, and the second portion 164 of the outer cannula connector 130 may not contact the outer wall of the proximal region 144. There may be a gap (G) formed between the outer wall of the proximal region 144 and the inner wall of the outer cannula connector 130 (at the second portion 164) (see FIG. 4B).

[0071] Figure 5A is a perspective view of an exemplary tracheostomy tube assembly 100d with an inner cannula (not visible in Figure 5A) fully inserted into an outer cannula 110 via an outer cannula connector 130. Figure 5B is a side view of the exemplary tracheostomy tube assembly 100d of Figure 5A.

[0072] The exemplary tracheostomy tube assembly 100d of FIG. 5A is substantially identical to or similar to the exemplary tracheostomy tube assembly 100c of FIG. 4A, except that the exemplary tracheostomy tube assembly 100d of FIG. 5A includes larger gripping protrusions 150 compared to the smaller gripping protrusions 148 of the exemplary tracheostomy tube assembly 100c of FIG. 4A.

[0073] 5B, in some embodiments, the outer wall of inner cannula proximal region 144 may contact the inner wall of outer cannula connector 130. In these embodiments, the outer wall of inner cannula proximal region 144 may not be tapered or may be less tapered than the outer wall of inner cannula proximal region 144 shown in FIG.

[0074] FIG. 5C is a side view of another exemplary tracheostomy tube assembly 100e. The exemplary tracheostomy tube assembly 100e of FIG. 5C is substantially identical to the exemplary tracheostomy tube assembly 100d of FIGS. 5A and 5B, except that the exemplary tracheostomy tube assembly 100e of FIG. 5C includes deeper gripping protrusions 152 compared to the gripping protrusions 150 of the exemplary tracheostomy tube assembly 100d of FIGS. 5A and 5B. In some embodiments, similar to the embodiment of FIG. 4B, the outer cannula connector 130 includes a first portion 162 that may contact the outer wall of the proximal region 144 and a second portion 164 that may not contact the outer wall of the proximal region 144, thereby forming a gap (G) between the outer wall of the proximal region 144 and the inner wall of the outer cannula connector 130 (at the second portion 164). However, the present disclosure is not limited thereto. For example, similar to the embodiment of Figure 5B, the outer wall of the proximal region 144 of the inner cannula may contact the inner wall of the outer cannula connector 130. For convenience, mating projections and recesses are not shown in Figure 5C.

[0075] Figure 6A is a perspective view of an exemplary tracheostomy tube assembly 100f with an inner cannula (not visible in Figure 6A) fully inserted into an outer cannula 110 via an outer cannula connector 130. Figure 6B is a top view of the exemplary tracheostomy tube assembly 100f of Figure 6A. Figure 6C is a side view of the exemplary tracheostomy tube assembly 100f of Figure 6A.

[0076] The exemplary tracheostomy tube assembly 100f of Figure 6A is substantially the same as or similar to the exemplary tracheostomy tube assembly 100e of Figure 5C, except that the exemplary tracheostomy tube assembly 100f of Figure 6A includes deeper gripping protrusions 166 compared to gripping protrusions 152 of the exemplary tracheostomy tube assembly 100e of Figure 5C. In these embodiments, the outer cannula connector 130 may include a deeper notch 138.

[0077] The notch 138 may include an opening distance similar to that of FIG. 2B (e.g., between about 8 mm and about 15 mm). The notch 138 may have a depth (W1) greater than the depth (W) of the embodiment of FIG. 2B. For example, the depth (W1) may be between about 4 mm and about 15 mm (e.g., about 4 mm, about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, and ranges between these values). For example, the depth (W1) of the notch 138 may be between about 6 mm and about 12 mm. <How to use the tracheostomy tube assembly>

[0078] FIG. 7 is a flowchart illustrating an exemplary procedure 700 for using a tracheostomy tube assembly. The exemplary procedure 700 involves inserting an inner cannula into an outer cannula. The procedure illustrated in FIG. 7 is provided for illustrative purposes only. It will be understood that one or more of the steps of the procedure illustrated in FIG. 7 may be omitted and the order of the steps may be changed. For convenience, the procedure 700 will be described with reference to the tracheostomy tube assembly 100 shown in FIG. 1 . However, the exemplary procedure 700 can also be used with other tracheostomy tube assemblies disclosed herein. It is assumed that a tracheostomy tube, including an outer cannula 110, an outer cannula connector 130, and a flange, is already installed in the trachea, and the procedure 700 involves inserting the inner cannula 140 into the installed tracheostomy tube.

[0079] In step 710, the user may begin inserting the inner cannula 140 into the outer cannula 110. As disclosed herein, the user may be the patient themselves, or a caregiver or medical professional handling the tracheostomy tube assembly 100 for the patient. In some embodiments, the user may first grasp or hold at least one of the flange 120 or the outer cannula connector 130 with one hand. This step may serve to keep the outer cannula 110, flange 120, and / or outer cannula connector 130 from moving, thereby stabilizing the tracheostomy tube assembly 100 and preventing discomfort to the user (if the user is the patient) or the patient (if the user is a caregiver or medical professional). The user may use either the left or right hand for this step. In a non-limiting example, a user may grasp or hold grip projections 148 of inner cannula 140 with the other hand and insert inner cannula 140 into outer cannula 110 through connector opening 180 (see FIG. 2A ) of outer cannula connector 130. In another non-limiting example, a user may grasp or hold face 154 or 156 of inner cannula 140 with the other hand and insert inner cannula 140 into outer cannula 110 through connector opening 180 (see FIG. 2A ) of outer cannula connector 130. A user may use either the right or left hand for this step. A user may begin inserting inner cannula 140 into connector opening 180 while holding at least one of flange 120 or outer cannula connector 130 with one hand and grip projections 148 or face 154 or 156 with the other hand.

[0080] In step 720, the user can continue inserting inner cannula 140 until the mating protrusions and / or mating recesses of inner cannula 140 engage with the mating protrusions and / or mating recesses of outer cannula connector 130. The user can also continue inserting inner cannula 140 into connector opening 180 while holding at least one of flange 120 or outer cannula connector 130 with one hand and grip protrusion 148 or face 154 or 156 with the other hand. In a non-limiting example, inner cannula 140 may include one or more mating protrusions, and outer cannula connector 130 may include one or more mating recesses configured to engage with the one or more mating protrusions. In another non-limiting example, inner cannula 140 may include one or more mating recesses, and outer cannula connector 130 may include one or more mating protrusions configured to engage with the one or more mating recesses. In another non-limiting example, inner cannula 140 may include two or more mating protrusions, and outer cannula connector 130 may include one or more mating protrusions configured to latch between two or more mating protrusions of inner cannula 140. In another non-limiting example, outer cannula connector 130 may include two or more mating protrusions, and inner cannula 140 may include one or more mating protrusions and may be configured to latch between two or more mating protrusions of outer cannula connector 130. A user can sense engagement between a mating protrusion and a recess, or between two or more protrusions and one or more protrusions.

[0081] In step 730, the user can complete the insertion of inner cannula 140 into outer cannula 110 by exposing gripping projections 148 from notches 132 formed in outer cannula connector 130. The user can release both hands once inner cannula 140 is fully inserted into outer cannula 110. The patient may then use tracheostomy tube assembly 100.

[0082] FIG. 8 is a flow chart illustrating another exemplary procedure 800 for using a tracheostomy tube assembly. The exemplary procedure 800 is for removing the inner cannula 140 from the outer cannula 110. The procedure illustrated in FIG. 8 is provided for illustrative purposes only. It will be understood that one or more of the steps of the procedure illustrated in FIG. 8 may be omitted and the order of the steps may be changed. For convenience, the procedure 800 will be described with reference to the tracheostomy tube assembly 100 illustrated in FIG. 1 . However, the exemplary procedure 800 can also be used with other tracheostomy tube assemblies disclosed herein. The removal procedure 800 of FIG. 8 is generally the reverse of the insertion procedure 700 of FIG. 7 . It is assumed that the tracheostomy tube assembly 700, including the outer cannula 110, outer cannula connector 130, flange 120, and inner cannula 140, has already been installed, and the procedure 800 is for removing the inner cannula 140 from the installed tracheostomy tube assembly 100.

[0083] In step 810, the user may begin removing inner cannula 140 from outer cannula 110. In some embodiments, the user may first grasp or hold at least one of flange 120 or outer cannula connector 130 with one hand (e.g., left or right) to stabilize tracheostomy tube assembly 100. The user may also grasp or hold gripping projections 148 on inner cannula 140 (or face 154 in FIG. 3E or face 156 in FIG. 3F ) with the other hand (e.g., right or left) and begin removing inner cannula 130 from outer cannula 110. The user may begin removing inner cannula 140 from outer cannula 110 while holding at least one of flange 120 or outer cannula connector 130 with one hand and gripping projections 148 or face 154 or 156 with the other hand.

[0084] In step 820, the user can continue to remove inner cannula 140 until the mating protrusions and / or mating recesses of inner cannula 140 disengage from the mating protrusions and / or mating recesses of outer cannula connector 130. The user can also continue to remove inner cannula 140 from outer cannula 110 while holding at least one of flange 120 or outer cannula connector 130 with one hand and gripping protrusions 148 or faces 154 or 156 with the other hand. The user can sense when the mating protrusions and recesses disengage, or when two or more protrusions and one or more protrusions disengage.

[0085] In step 830, the user may complete the removal of inner cannula 140 from outer cannula 110. The user may release both hands once inner cannula 140 is completely removed from outer cannula 110. The user may then clean the removed inner cannula 140. After cleaning is complete, the user may return inner cannula 140 to outer cannula 110. <Other Examples>

[0086] Various exemplary embodiments of the present disclosure can be described by the following clauses.

[0087] Section 1 an outer cannula configured to be disposed within a trachea, the outer cannula having a distal end and a proximal end, the distal end configured to be disposed within the trachea and the proximal end opposite the distal end and configured to be exposed to the environment; and an outer cannula connector configured to be coupled to the outer cannula, the outer cannula connector including a proximal region including a notch extending in a length direction of the outer cannula connector, the outer cannula connector including at least one of a non-annular mating recess or a non-annular mating protrusion formed in an inner wall thereof, the outer cannula connector including a connector opening; and an inner cannula comprising: a distal region and a proximal region opposite the distal region, the distal region configured to be disposed inside the outer cannula, and an inner cannula, the proximal region of the inner cannula configured to be inserted into the proximal region of the outer cannula connector through the connector opening, the proximal region of the inner cannula including gripping projections extending from an outer wall of the proximal region of the inner cannula, the outer wall configured to face the inner wall of the outer cannula connector, the gripping projections configured to be at least partially received within and exposed by the notches in the proximal region of the outer cannula connector when the inner cannula is inserted into the outer cannula, and the inner cannula including at least one of non-annular mating projections or non-annular mating recesses formed in the outer wall and configured to engage with the non-annular mating recesses or at least one of the non-annular mating projections of the outer cannula connector.

[0088] Section 2 2. The assembly of claim 1, wherein the gripping projections are configured to be fully received in notches in a proximal region of the outer cannula connector.

[0089] Section 3 3. The assembly of claim 1 or 2, wherein the gripping projection has approximately the same dimensions as the notch.

[0090] Section 4 The assembly of any one of paragraphs 1 to 3, wherein the notches include a first notch disposed on a first side of the proximal region of the outer cannula connector and a second notch disposed on a second side of the proximal region of the outer cannula connector, and the gripping projections include a first gripping projection configured to be received in the first notch and a second gripping projection configured to be received in the second notch.

[0091] Section 5 5. The assembly of claim 4, wherein the first side and the second side are opposed.

[0092] Section 6 6. The assembly of claim 4 or 5, wherein the first gripping protrusion and the second gripping protrusion are disposed on opposite sides of the outer wall of the proximal region of the inner cannula.

[0093] Item 7: The assembly according to any one of items 1 to 6, wherein the gripping protrusions include a plurality of pairs of gripping protrusions spaced apart from one another.

[0094] Clause 8. The assembly of clause 7, wherein each of the sets of gripping projections includes two or more gripping projections.

[0095] Section 9 8. The assembly of claim 7, wherein the plurality of sets of gripping projections includes a first set of one or more gripping projections and a second set of one or more gripping projections spaced apart from one another.

[0096] Section 10 10. The assembly of claim 9, wherein the number of the one or more gripping protrusions in the first set is different from the number of the one or more gripping protrusions in the second set.

[0097] Section 11 10. The assembly of clause 9, wherein the number of the one or more gripping protrusions in the first set is the same as the number of the one or more gripping protrusions in the second set.

[0098] Section 12 12. The assembly according to any one of claims 7 to 11, wherein the notches include a plurality of sets of notches configured to respectively receive the plurality of sets of gripping protrusions.

[0099] Section 13 13. The assembly according to any one of items 1 to 12, wherein the non-annular mating recess includes a plurality of mating recesses that are discontinuous with each other and spaced apart from each other.

[0100] Section 14 Item 14. The assembly of item 13, wherein the plurality of mating recesses include a first non-annular mating recess and a second non-annular mating recess disposed on opposite sides of the inner wall of the proximal region of the outer cannula connector.

[0101] Section 15 15. The assembly according to any one of items 1 to 14, wherein the non-annular mating projection includes a plurality of mating projections that are discontinuous and spaced apart from one another.

[0102] Section 16 16. The assembly of clause 15, wherein the plurality of mating projections include a first non-annular mating projection and a second non-annular mating projection disposed on opposite sides of the inner wall of the proximal region of the inner cannula.

[0103] Section 17 16. The assembly of claim 15, wherein the plurality of mating projections includes a first set of one or more mating projections and a second set of one or more mating projections spaced apart from the first set of one or more mating projections.

[0104] Section 18 18. The assembly of any one of paragraphs 1 to 17, wherein the proximal region of the outer cannula connector includes a tapered portion adjacent the notch.

[0105] Section 19 The assembly described in any one of paragraphs 1 to 18, wherein the outer end of the proximal region of the inner cannula is configured to be flush with the outer end of the proximal region of the outer cannula connector when the inner cannula is inserted into the outer cannula.

[0106] Section 20 20. The assembly according to any one of claims 1 to 19, wherein the gripping projection is substantially aligned with the fitting projection in the longitudinal direction of the inner cannula.

[0107] Section 21 21. The assembly according to any one of paragraphs 1 to 20, wherein the gripping protrusions are tapered.

[0108] Section 22 22. The assembly of any one of claims 1 to 21, wherein the proximal region of the inner cannula includes a face at its outer end, the face having a larger diameter than an adjacent portion of the proximal region of the inner cannula immediately adjacent to the face.

[0109] Section 23 23. The assembly of clause 22, wherein the face is configured to rest against a ridge on the proximal region of the outer cannula connector when the inner cannula is inserted into the outer cannula.

[0110] Section 24 24. The assembly of any one of paragraphs 1 to 23, wherein the proximal region of the inner cannula is tapered.

[0111] Section 25 an outer cannula configured to be placed within a trachea, the outer cannula having a distal end and a proximal end, the distal end configured to be placed within the trachea and the proximal end opposite the distal end and configured to be exposed to the environment; and an outer cannula connector configured to be coupled to the outer cannula, the outer cannula connector including a proximal region, the proximal region including a notch extending a length of the outer cannula connector, the outer cannula connector including a connector opening; and an inner cannula comprising: a distal region and a proximal region opposite the distal region, the distal region comprising: an inner cannula configured to be disposed inside the outer cannula, the proximal region of the inner cannula configured to be inserted into the proximal region of the outer cannula connector through the connector opening, the proximal region of the inner cannula including gripping projections extending from an outer wall of the proximal region of the inner cannula, the outer wall configured to face the inner wall of the outer cannula connector, the gripping projections configured to be at least partially received within and exposed by the notches in the proximal region of the outer cannula connector when the inner cannula is inserted into the outer cannula.

[0112] Section 26 26. The assembly of claim 25, wherein the outer cannula connector includes an inner wall configured to face an outer wall of the proximal region of the inner cannula, the outer cannula connector including at least one of a non-annular mating recess or a non-annular mating protrusion formed in the inner wall, and the inner cannula includes at least one of a non-annular mating protrusion or a non-annular mating recess formed in the outer wall and configured to engage with the at least one of the non-annular mating recess or the non-annular mating protrusion of the outer cannula connector.

[0113] Section 27 27. The assembly of clause 26, wherein at least one of the inner wall of the outer cannula connector or the outer wall of the proximal region of the inner cannula is tapered.

[0114] Section 28 28. The assembly of clause 27, wherein both the inner wall of the outer cannula connector and the outer wall of the proximal region of the inner cannula are tapered in opposite directions.

[0115] Section 29 29. The assembly of any one of claims 26 to 28, wherein the gripping projections are configured to be fully received in notches in the proximal region of the outer cannula connector.

[0116] Section 30 30. The assembly according to any one of items 26 to 29, wherein the non-annular mating recess includes a plurality of sets of mating recesses that are discontinuous and spaced apart from one another.

[0117] Section 31 31. The assembly according to any one of items 26 to 30, wherein the non-annular mating projections include a plurality of sets of mating projections that are discontinuous and spaced apart from one another.

[0118] Section 32 an outer cannula configured to be placed inside a trachea, the outer cannula having a distal end and a proximal end, the distal end configured to be placed inside the trachea and the proximal end opposite the distal end and configured to be exposed to the environment; an outer cannula connector configured to be coupled to the outer cannula, the outer cannula connector including a proximal region, the outer cannula connector including at least one of a non-annular mating recess or a non-annular mating protrusion formed on an inner wall thereof, the outer cannula connector including a connector opening; and an inner cannula comprising a distal region and a proximal region opposite the distal region, the distal region configured to be placed inside the outer cannula, the proximal region of the inner cannula being connected to the outer cannula through the connector opening. and an inner cannula configured to be inserted into the proximal region of the outer cannula connector, the inner cannula including at least one of a non-annular mating recess or a non-annular mating protrusion formed on an outer wall configured to face the inner wall of the outer cannula connector, the at least one of the non-annular mating protrusion or the non-annular mating recess of the inner cannula configured to engage with the at least one of the non-annular mating recess or the non-annular mating protrusion of the outer cannula connector, the proximal region of the inner cannula including a face portion at an outer end thereof, the face portion having a larger diameter than an adjacent portion of the proximal region of the inner cannula immediately adjacent the face portion, the face portion configured to rest on a ridge on the proximal region of the outer cannula connector when the inner cannula is inserted into the outer cannula.

[0119] Section 33 33. The assembly of claim 32, wherein the proximal region of the outer cannula connector includes a notch extending lengthwise of the outer cannula connector, and the proximal region of the inner cannula includes gripping projections extending from the outer wall of the proximal region of the inner cannula, the gripping projections being configured to be at least partially received within and exposed by the notch in the proximal region of the outer cannula connector when the inner cannula is inserted into the outer cannula.

[0120] Section 34 a body configured to be disposed within an outer cannula of a tracheal tube assembly, the outer cannula configured to be disposed within a trachea and configured to be coupled to an outer cannula connector, the outer cannula including a distal end configured to be disposed within the trachea and a proximal end opposite the distal end configured to be exposed to the environment, the outer cannula connector including a notch extending along the length of the cannula connector, the outer cannula connector including at least one of a non-annular mating recess or a non-annular mating protrusion formed on an inner wall thereof; and a proximal end extending from the body and exposed to the environment. 1. An inner cannula for a tracheal tube assembly, comprising: a head configured to be inserted into the outer cannula connector, the head including gripping projections extending from an outer wall thereof, the gripping projections configured to be at least partially received within and exposed by the notches of the outer cannula connector when the body is inserted into the outer cannula; and at least one of a non-annular mating projection or a non-annular mating recess formed on the outer wall of the head, the non-annular mating projection or a non-annular mating recess configured to engage with the non-annular mating recess or the non-annular mating projection of the outer cannula connector.

[0121] Section 35 35. The inner cannula of clause 34, wherein the gripping projections are configured to be fully received within the notches.

[0122] Section 36 36. The inner cannula of claim 34 or 35, wherein the non-annular mating recesses include a plurality of sets of mating recesses that are discontinuous and spaced apart from one another.

[0123] Section 37 37. The assembly according to any one of items 34 to 36, wherein the non-annular mating projections include a plurality of sets of mating projections that are discontinuous and spaced apart from one another.

[0124] Section 38 1. A method of using a tracheostomy tube assembly, comprising: providing a tracheostomy tube including an outer cannula, a flange, and an outer cannula connector, wherein the flange is coupled to the outer cannula and the outer cannula connector, the outer cannula connector including a notch extending lengthwise of the cannula connector, the outer cannula connector including a connector opening, the outer cannula connector including at least one of a non-annular mating recess or a non-annular mating protrusion formed on an inner wall thereof, the tracheostomy tube being positioned in the trachea such that the outer cannula is disposed within the trachea and the flange is exposed to the environment and pressed against the neck; and providing an inner cannula including a proximal region, wherein the proximal region a proximal region of an outer cannula connector including a gripping projection extending from an outer wall thereof, the outer wall configured to face the inner wall of the outer cannula connector, the inner cannula including at least one of a non-annular mating projection or a non-annular mating recess formed in the outer wall, the method comprising: starting insertion of the inner cannula into the outer cannula through the connector opening; engaging the non-annular mating projection or the mating recess of the inner cannula with the non-annular mating recess or the non-annular mating projection of the outer cannula connector; and completing insertion of the inner cannula into the outer cannula by exposing the gripping projection of the inner cannula through a notch in the outer cannula connector.

[0125] Section 39 39. The method of clause 38, wherein the initiating includes holding at least one of the flange or the outer cannula connector with one hand and grasping the gripping protrusions of the inner cannula with the other hand; and inserting the inner cannula into the outer cannula through the connector opening while holding at least one of the flange or the outer cannula connector with the one hand and grasping the gripping protrusions of the inner cannula with the other hand.

[0126] Section 40 40. The method of clause 39, wherein the gripping protrusions include two gripping protrusions, the notches include two notches configured to accommodate the two gripping protrusions respectively, and the grasping includes grasping the two gripping protrusions with at least two fingers of the other hand.

[0127] Section 41 The method of any one of paragraphs 38 to 40, wherein the inner cannula includes two or more non-annular mating protrusions and the outer cannula connector includes two or more non-annular mating recesses, and the engaging step includes engaging the two or more non-annular mating protrusions of the inner cannula with the two or more non-annular mating recesses of the outer cannula connector.

[0128] Section 42 42. The method of any one of claims 38 to 41, wherein the inner cannula includes two or more non-annular mating projections, the outer cannula connector includes one or more non-annular mating projections such that the number of the one or more non-annular mating projections is less than the number of the two or more non-annular mating projections, and the engaging includes engaging the two or more non-annular mating projections of the inner cannula with the one or more non-annular mating projections of the outer cannula connector such that the one or more non-annular mating projections of the outer cannula connector are latched between the two or more non-annular mating projections of the inner cannula.

[0129] Section 43 43. The method of any one of paragraphs 38 to 42, wherein the proximal region of the inner cannula includes a face at its outer end, the face having a larger diameter than an adjacent portion of the proximal region immediately adjacent the face, and wherein the starting includes holding at least one of the flange or the outer cannula connector with one hand and grasping the face of the inner cannula with the other hand, and inserting the inner cannula into the outer cannula through the connector opening while holding at least one of the flange or the outer cannula connector with the one hand and grasping the face of the inner cannula with the other hand.

[0130] Section 44 1. A method of using a tracheostomy tube assembly, the method comprising: providing a tracheostomy tube including an outer cannula, a flange, and an outer cannula connector, the flange being coupled to the outer cannula and the outer cannula connector, the outer cannula connector including a notch extending along the length of the cannula connector, the outer cannula connector including a connector opening; the tracheostomy tube being placed in the trachea such that the outer cannula is positioned within the trachea and the flange is exposed to the environment and pressed against the neck; providing an inner cannula including a proximal region including gripping projections extending from an outer wall of the proximal region, the outer wall being configured to face the inner wall of the outer cannula connector; and completing insertion of the inner cannula into the outer cannula by exposing the gripping projections of the inner cannula through the connector opening.

[0131] Section 45 45. The method of claim 44, wherein the outer cannula connector includes at least one of a non-annular mating recess or a non-annular mating protrusion formed on an inner wall thereof, and the inner cannula includes at least one of a non-annular mating protrusion or a non-annular mating recess formed on an outer wall facing the inner wall, and further comprising, before completing the step, engaging at least one of the non-annular mating protrusion or mating recess of the inner cannula with at least one of the non-annular mating recess or the non-annular mating protrusion of the outer cannula connector.

[0132] Section 46 46. ​​The method of clause 45, wherein the initiating includes holding at least one of the flange or the outer cannula connector with one hand and grasping the gripping protrusions of the inner cannula with the other hand; and inserting the inner cannula into the outer cannula through the connector opening while holding at least one of the flange or the outer cannula connector with the one hand and grasping the gripping protrusions of the inner cannula with the other hand.

[0133] Section 47 47. The method of claim 45 or 46, wherein the gripping protrusions include two gripping protrusions, the notches include two notches configured to accommodate the two gripping protrusions respectively, and the grasping includes grasping the two gripping protrusions with at least two fingers of the other hand.

[0134] Section 48 48. The method of any one of paragraphs 44 to 47, wherein the proximal region of the inner cannula includes a face at its outer end, the face having a larger diameter than an adjacent portion of the proximal region immediately adjacent the face, and the starting includes holding at least one of the flange or the outer cannula connector with one hand and grasping the face of the inner cannula with the other hand, and inserting the inner cannula into the outer cannula through the connector opening while holding at least one of the flange or the outer cannula connector with the one hand and grasping the face of the inner cannula with the other hand.

[0135] Section 49 A method of using a tracheostomy tube assembly, comprising providing a tracheostomy tube assembly for placement within a trachea, the tracheostomy tube assembly including an outer cannula, a flange, an outer cannula connector, and an inner cannula, the flange supporting the outer cannula and the outer cannula connector, the outer cannula connector coupled to the outer cannula and including a connector opening, the outer cannula connector including a notch extending along the length of the cannula connector, the outer cannula connector including at least one of a non-annular mating recess or a non-annular mating protrusion formed in an inner wall thereof, the inner cannula being positioned inside the outer cannula and the outer cannula connector. the inner cannula includes a proximal region, the proximal region of the inner cannula including gripping protrusions, the inner cannula including at least one of a non-annular mating protrusion or a non-annular mating recess formed on an outer wall of the proximal region, the outer wall configured to face the inner wall of the outer cannula connector, the method comprising: initiating removal of the inner cannula from the outer cannula; disengaging the at least one of the non-annular mating recess or the non-annular mating protrusion of the outer cannula connector from the at least one of the non-annular mating protrusion or the mating recess of the inner cannula; and completing removal of the inner cannula from the outer cannula by separating the inner cannula from the outer cannula connector.

[0136] Section 50 50. The method of clause 49, wherein the initiating includes holding at least one of the flange or the outer cannula connector with one hand and grasping the gripping protrusions of the inner cannula with the other hand, and removing the inner cannula from the outer cannula while holding at least one of the flange or the outer cannula connector with the one hand and grasping the gripping protrusions of the inner cannula with the other hand.

[0137] Section 51 51. The method of claim 49 or 50, wherein the gripping protrusions include two gripping protrusions, the notches include two notches configured to accommodate the two gripping protrusions respectively, and the grasping includes grasping the two gripping protrusions with at least two fingers of the other hand.

[0138] Section 52 The method of any one of paragraphs 49 to 51, wherein the inner cannula includes two or more non-annular mating protrusions and the outer cannula connector includes two or more non-annular mating recesses, and the engaging step includes engaging the two or more non-annular mating protrusions of the inner cannula with the two or more non-annular mating recesses of the outer cannula connector.

[0139] Section 53 53. The method of any one of paragraphs 49 to 52, wherein the inner cannula includes two or more non-annular mating projections, the outer cannula connector includes one or more non-annular mating projections, and the engaging includes engaging the two or more non-annular mating projections of the inner cannula with the one or more non-annular mating projections of the outer cannula connector such that the one or more non-annular mating projections of the outer cannula connector are latched between the two or more non-annular mating projections of the inner cannula.

[0140] Section 54 54. The method of any one of paragraphs 49 to 53, wherein the proximal region of the inner cannula includes a face at its outer end, the face having a larger diameter than an adjacent portion of the proximal region immediately adjacent to the face, and the starting includes holding at least one of the flange or the outer cannula connector with one hand and grasping the face of the inner cannula with the other hand, and removing the inner cannula from the outer cannula while holding at least one of the flange or the outer cannula connector with the one hand and grasping the face of the inner cannula with the other hand.

[0141] Section 55 1. A method of using a tracheostomy tube assembly, the method comprising: providing a tracheostomy tube assembly for placement in a trachea, the tracheostomy tube assembly including an outer cannula, a flange, an outer cannula connector, and an inner cannula, the flange supporting the outer cannula and the outer cannula connector, the outer cannula connector coupled to the outer cannula and including a connector opening, the outer cannula connector including a notch extending along the length of the cannula connector, the inner cannula being disposed inside the outer cannula and the outer cannula connector, the inner cannula including a proximal region, the proximal region of the inner cannula including gripping protrusions extending from an outer wall of the proximal region of the inner cannula; and completing the removal of the inner cannula from the outer cannula by separating the inner cannula from the outer cannula connector.

[0142] Section 56 56. The method of claim 55, wherein the outer cannula connector includes at least one of a non-annular mating recess or a non-annular mating protrusion formed on an inner wall thereof, and the inner cannula includes at least one of a non-annular mating protrusion or a non-annular mating recess formed on an outer wall of the proximal region, and the method includes disengaging the at least one of the non-annular mating recess or the non-annular mating protrusion of the outer cannula connector from the at least one of the non-annular mating protrusion or the mating recess of the inner cannula.

[0143] Section 57 57. The method of claim 55 or 56, wherein the starting includes holding at least one of the flange or the outer cannula connector with one hand and grasping the gripping protrusions of the inner cannula with the other hand, and removing the inner cannula from the outer cannula while holding at least one of the flange or the outer cannula connector with the one hand and grasping the gripping protrusions of the inner cannula with the other hand.

[0144] Section 58 The method according to any one of paragraphs 55 to 57, wherein the gripping protrusions include two gripping protrusions, the notches include two notches configured to accommodate the two gripping protrusions respectively, and gripping the gripping protrusions includes gripping the two gripping protrusions with at least two fingers of the other hand.

[0145] Section 59 The method of any of paragraphs 55 to 58, wherein the proximal region of the inner cannula includes a face at its outer end, the face having a larger diameter than an adjacent portion of the proximal region immediately adjacent to the face, and the starting includes holding at least one of the flange or the outer cannula connector with one hand and grasping the face of the inner cannula with the other hand, and removing the inner cannula from the outer cannula while holding at least one of the flange or the outer cannula connector with the one hand and grasping the face of the inner cannula with the other hand.

[0146] Section 60 an outer cannula configured to be placed within a trachea, the outer cannula having a distal end and a proximal end, the distal end configured to be placed within the trachea and the proximal end opposite the distal end and configured to be exposed to the environment; an outer cannula connector configured to be coupled to the outer cannula, the outer cannula connector including a proximal region, the proximal region including a notch extending a length of the outer cannula connector, the outer cannula connector including a connector opening; and an inner cannula comprising a distal region and a proximal region opposite the distal region, the distal region configured to be placed inside the outer cannula, the proximal region of the inner cannula being adapted to be inserted into the proximal region of the outer cannula connector through the connector opening. an inner cannula, wherein the proximal region of the inner cannula includes gripping protrusions extending from an outer wall of the proximal region of the inner cannula, the gripping protrusions configured to be at least partially received within and exposed by the notches in the proximal region of the outer cannula connector when the inner cannula is inserted into the outer cannula, the inner cannula including at least one of a non-annular mating protrusion or a non-annular mating recess formed in the outer wall of the proximal region, the outer cannula connector including an inner wall configured to face the outer wall of the proximal region of the inner cannula, the outer cannula connector including at least one of a non-annular mating recess or a non-annular mating protrusion formed in the inner wall configured to engage with the at least one of the non-annular mating protrusion or the non-annular mating recess of the inner cannula.

[0147] Section 61 an outer cannula configured to be placed within a trachea, the outer cannula having a distal end and a proximal end, the distal end configured to be placed within the trachea and the proximal end opposite the distal end and configured to be exposed to the environment; and an outer cannula connector configured to be coupled to the outer cannula, the outer cannula connector including a proximal region, the proximal region including a notch extending a length of the outer cannula connector, the outer cannula connector including a connector opening; and an inner cannula connector comprising a distal region and a proximal region opposite the distal region. and an inner cannula, the distal region of which is configured to be disposed inside the outer cannula, the proximal region of the inner cannula configured to be inserted into the proximal region of the outer cannula connector through the connector opening, the proximal region of the inner cannula including gripping projections extending from an outer wall of the proximal region of the inner cannula, the gripping projections configured to be at least partially received within and exposed by the notches in the proximal region of the outer cannula connector when the inner cannula is inserted into the outer cannula.

[0148] While certain embodiments are described herein with one set of mating features on the inner cannula and another set of mating features on the outer cannula, it should be understood that the features on the inner and outer cannula may be reversed. For example, while certain embodiments are described as having a mating recess on the outer cannula and a mating protrusion on the inner cannula, it is also envisioned that a mating recess is on the inner cannula and a mating protrusion is on the outer cannula. Furthermore, while certain embodiments are described as having a single mating feature on the outer cannula mating with a pair of mating features on the inner cannula, this arrangement may be reversed.

[0149] As used herein, conditional language (such as "can," "could," "might," "may," "eg," etc.) is generally intended to convey that certain embodiments include certain features, elements, and / or conditions, and other embodiments do not, unless otherwise specified or the context of use requires otherwise. The terms "comprising," "including," "having," etc. are synonymous and are used inclusively and open-endedly and do not exclude additional elements, features, acts, operations, etc.

[0150] Ranges disclosed herein encompass all overlaps, subranges, and combinations thereof. Terms such as "up to," "at least," "greater than," "less than," and "between" are inclusive of the referenced number. Numbers preceded by terms such as "about" or "approximately" are inclusive of the referenced number and should be interpreted in accordance with the context (e.g., as precisely as reasonably possible given the circumstances, e.g., ±5%, ±10%, ±15%, etc.). For example, "about 0.3 inches" is intended to include "0.3 inches." Terms preceded by terms such as "substantially" are inclusive of the referenced number and should be interpreted in accordance with the context (e.g., as precisely as reasonably possible given the circumstances). For example, "substantially covers" includes "completely covers." Unless otherwise specified, all measurements are taken under standard conditions, including those regarding temperature and pressure. The phrase "at least one of" is intended to require at least one item from the subsequent list, not one of each item in the subsequent list. For example, "at least one of A, B, and C" may include A, B, C, A and B, A and C, B and C, or A, B, and C.

[0151] Alternative language such as "at least one of X, Y, Z" is understood in conjunction with the context as generally used to indicate that an item, term, etc. may be either X, Y, Z, or any combination thereof (e.g., X, Y, and / or Z), unless otherwise noted. Thus, such alternative language is generally not intended to, and should not suggest, that a particular embodiment requires that at least one of X, at least one of Y, and at least one of Z be present.

[0152] Unless expressly stated otherwise, articles such as "a" or "an" should generally be construed to include one or more of the described items. Thus, phrases such as "an apparatus configured to" are intended to include one or more of the described apparatuses. Such one or more described apparatuses may be collectively configured to perform the specified items. For example, "a processor configured to perform descriptions A, B, and C" may include a first processor configured to perform description A in cooperation with a second processor configured to perform descriptions B and C.

[0153] Although the methods disclosed herein may include specific actions performed by a practitioner, the methods may also include, explicitly or implicitly, any third-party instruction of those actions. For example, an action such as "connecting a tracheostomy occlusion adapter to a tracheostomy tube" includes "instructing the connection of the tracheostomy occlusion adapter to a tracheostomy tube."

Claims

1. 1. An outer cannula configured to be placed in the trachea, the outer cannula having a distal end and a proximal end; the distal end is configured to be placed within the trachea; an outer cannula, the proximal end opposite the distal end and configured to be exposed to the environment; an outer cannula connector configured to be coupled to the outer cannula, the outer cannula connector includes a proximal region; the proximal region includes a notch extending along the length of the outer cannula connector; the outer cannula connector includes at least one of a non-annular mating recess or a non-annular mating protrusion formed on an inner wall thereof; an outer cannula connector, the outer cannula connector including a connector opening; 1. An inner cannula comprising a distal region and a proximal region opposite the distal region, the distal region is configured to be disposed inside the outer cannula; the proximal region of the inner cannula is configured to be inserted into the proximal region of the outer cannula connector through the connector opening; the proximal region of the inner cannula includes gripping projections extending from an outer wall of the proximal region of the inner cannula, the outer wall configured to face the inner wall of the outer cannula connector; the gripping projections are configured to be at least partially received within and exposed by the notches in the proximal region of the outer cannula connector when the inner cannula is inserted into the outer cannula; an inner cannula including at least one of a non-annular mating protrusion or a non-annular mating recess formed in the outer wall and configured to engage with at least one of the non-annular mating recess or the non-annular mating protrusion of the outer cannula connector; A tracheal tube assembly comprising:

2. The assembly of claim 1 , wherein the gripping projections are configured to be fully received in the notches in the proximal region of the outer cannula connector.

3. 3. The assembly of claim 1 or 2, wherein the gripping projection has approximately the same dimensions as the notch.

4. the notches include a first notch disposed on a first side of the proximal region of the outer cannula connector and a second notch disposed on a second side of the proximal region of the outer cannula connector; The gripping projections include a first gripping projection configured to be received in the first notch and a second gripping projection configured to be received in the second notch. Assembly according to any one of claims 1 to 3.

5. The assembly of claim 4 , wherein the first side and the second side are opposed.

6. The assembly of claim 4 or 5, wherein the first gripping projection and the second gripping projection are disposed on opposite sides of the outer wall of the proximal region of the inner cannula.

7. An assembly according to any preceding claim, wherein the gripping projections comprise a plurality of sets of gripping projections spaced apart from one another.

8. The assembly of claim 7 , wherein each of the sets of gripping projections includes two or more gripping projections.

9. The assembly of claim 7 , wherein the plurality of sets of gripping projections includes a first set of one or more gripping projections and a second set of one or more gripping projections spaced apart from one another.

10. 10. The assembly of claim 9, wherein a number of the one or more gripping projections in the first set is different from a number of the one or more gripping projections in the second set.

11. 10. The assembly of claim 9, wherein the number of the one or more gripping projections in the first set is the same as the number of the one or more gripping projections in the second set.

12. An assembly according to any one of claims 7 to 11, wherein the notches include a plurality of sets of notches configured to respectively receive the plurality of sets of gripping protrusions.

13. The assembly according to any one of claims 1 to 12, wherein the non-annular mating recess comprises a plurality of mating recesses that are discontinuous and spaced apart from one another.

14. The assembly of claim 13 , wherein the plurality of mating recesses includes a first non-annular mating recess and a second non-annular mating recess disposed on opposite sides of the inner wall of the proximal region of the outer cannula connector.

15. The assembly of any one of claims 1 to 14, wherein the non-annular mating projections comprise a plurality of mating projections that are discontinuous and spaced apart from one another.

16. The assembly of claim 15 , wherein the plurality of mating projections includes a first non-annular mating projection and a second non-annular mating projection disposed on opposite sides of the inner wall of the proximal region of the inner cannula.

17. 16. The assembly of claim 15, wherein the plurality of mating projections includes a first set of one or more mating projections and a second set of one or more mating projections spaced apart from the first set of one or more mating projections.

18. The assembly of any preceding claim, wherein the proximal region of the outer cannula connector includes a tapered portion adjacent the notch.

19. 19. The assembly of claim 1, wherein an outer end of the proximal region of the inner cannula is configured to be flush with an outer end of the proximal region of the outer cannula connector when the inner cannula is inserted into the outer cannula.

20. The assembly of any preceding claim, wherein the gripping projections are generally aligned with the mating projections along the length of the inner cannula.

21. An assembly according to any preceding claim, wherein the gripping projections are tapered.

22. 22. The assembly of any one of claims 1 to 21, wherein the proximal region of the inner cannula includes a face at its outer end, the face having a larger diameter than an adjacent portion of the proximal region of the inner cannula immediately adjacent the face.

23. 23. The assembly of claim 22, wherein the face is configured to rest against a ridge on the proximal region of the outer cannula connector when the inner cannula is inserted into the outer cannula.

24. The assembly of any preceding claim, wherein the proximal region of the inner cannula is tapered.

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