The present disclosure relates generally to the field of tracheal tubes and, more particularly, to a tracheal tube flange having customizable flanges.
This section is intended to introduce the reader to various aspects of art that may be related to various aspects of the present disclosure, which are described and/or claimed below. This discussion is believed to be helpful in providing the reader with background information to facilitate a better understanding of the various aspects of the present disclosure. Accordingly, it should be understood that these statements are to be read in this light, and not as admissions of prior art.
A wide variety of situations exist in which artificial ventilation of a patient may be desired. For short-term ventilation or during certain surgical procedures, endotracheal tubes may be inserted through the mouth to provide oxygen and other gasses to a patient. For other applications, particularly when longer-term intubation is anticipated, tracheostomy tubes may be preferred. Tracheostomy tubes are typically inserted through an incision made in the neck of the patient and through the trachea. A resulting stoma is formed between the tracheal rings below the vocal chords. The tracheostomy tube is then inserted through the opening.
The opening created by the tracheal tube may be utilized to define a clear passageway for air, other gases, and medicaments to the trachea and lungs, thus providing an artificial airway for spontaneous or mechanical ventilation of a patient. Such tracheal tubes may include endotracheal tubes and tracheostomy tubes. When the inner or distal end of the tracheostomy tube is properly inserted into the trachea, the tracheostomy tube may be secured in place by flanges (e.g., “wings”). The flanges may be positioned on the neck and may then be secured in placed by a strap such as a ribbon or soft tie. However, in patients having certain neck obstructions and/or having unusual anatomies, the flanges may not be suitable for their intended purpose. There is a need, therefore, for improved tracheal tubes, and particularly for improved tracheostomy tube flanges. It would be desirable to provide a tube flange that is customizable for a variety of anatomies.
This disclosure provides a novel tracheal tube having customizable flanges designed to respond to such needs. The tube flanges allow for a tailored fit at the clinical site, suitable for conforming to a variety of patient sizes and anatomies. Indeed, instead of submitting a special modification to the manufacturer, a clinician or user may customize the flange to fit a particular patient anatomy. In a tracheostomy tube embodiment, for example, the customizable flange fits adjacent to the neck of a patient and certain customizable features are provided, including areas with perforations and/or areas of reduced mechanical strength. The clinician or user may cut the flange to a desired shape and/or size by using the aforementioned areas. For example, the flange may be cut to a shape having a geometry suitable for avoiding a neck protrusion, or at a size suitable for comfortably fitting to a variety of patients.
In another embodiment, the customizable flange may include a “clip-on” flange member, such as a manually removable and replaceable member of the flange, as described in more detail below. Various flange members of different sizes and shapes may be provided, suitable for coupling with a receiving member of the customizable flange. Accordingly, the clinician or user may select a flange member more suitable for a given patient anatomy. The selected flange member may be manually secured to the flange, thus customizing the flange to comfortably fit the patient. Flange members of various sizes and shapes may be provided as a kit, thus enabling a custom fit at the clinical site. Indeed, the customizable flanges may allow for a proper positioning of the tracheal tube in a wide range of patients, including pediatric and adult patients. Different colors of flanges, flange portions, and cannulae may also be provided, useful in identifying parts as well as in improving aesthetics and providing for different styling options.
The systems disclosed herein also include a removable flange with flange features allowing the flange to be placed onto the patient's neck, prior to insertion, giving the clinician or user an opportunity to draw a profile onto the flange, and/or to assess a shape on the flange that may make the flange more comfortable while in use after insertion.
Thus, in accordance with a first aspect, a tracheal tube assembly includes a cannula configured to be positioned in a patient airway and a customizable flange configured to be secured about the cannula. The customizable flange further includes a first flange portion and a second flange portion. The second flange portion is configured to be selectively removed from the customizable flange to customize the length of the customizable flange.
In accordance with another aspect, a tracheal tube assembly includes a cannula configured to be positioned in a patient airway and a customizable flange configured to be secured about the cannula. The customizable flange further includes a receiving member and a first flange member. The first flange member is configured to be coupled to the receiving member to customize the length, the width, or a combination thereof, of the customizable flange.
Also disclosed herein is a tracheal tube assembly including a cannula configured to be positioned in a patient airway and a customizable flange configured to be secured about the cannula. The customizable flange comprises a first length and a first width. The customizable flange customizable flange is configured to be customized to a second length, a second width, or a combination thereof.
Various aspects of the disclosed techniques may become apparent upon reading the following detailed description and upon reference to the drawings in which:
One or more specific embodiments of the present techniques will be described below. In an effort to provide a concise description of these embodiments, not all features of an actual implementation are described in the specification. It should be appreciated that in the development of any such actual implementation, as in any engineering or design project, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with system-related and business-related constraints, which may vary from one implementation to another. Moreover, it should be appreciated that such a development effort might be complex and time consuming, but would nevertheless be a routine undertaking of design, fabrication, and manufacture for those of ordinary skill having the benefit of this disclosure.
A tracheal tube according to a preferred embodiment is illustrated in
A cannula 14 is illustrated extending both distally as well as proximally from the flange 12. The cannula 14 may include an opening 16 disposed on a proximal end of an end connector 18. During intubation, the tracheal tube assembly 10 is placed through an opening formed in the neck and trachea of a patient, and extending into the patient airway. The embodiment illustrated in the figures includes a sealing cuff 20, although in practice a wide range of tube designs may be used, including tubes having no cuffs or tubes having multiple cuffs around the outer cannula 14. The cannula 14 in the illustrated embodiment forms a conduit from which liquids or gases, including medications, may enter through the proximal opening 16 an exit through a distal opening 22. The cannula 14 has an outer dimension 24 allowing it to fit easily through an incision made in the neck and trachea of the patient. In practice, a range of such tubes may be provided to accommodate the different contours and sizes of patients and patient airways. Such tube families may include tubes designed for neonatal and pediatric patients as well as for adults. By way of example only, outer dimension 24 of the cannula 14 may range from 4 mm to 16 mm.
In one embodiment, the outer cannula 14 enters the flange 12 along a lower face 26 and protrudes through an upper face 28 of the flange 12. When in use, the face 26 will generally be positioned against the neck of a patient, with the cannula extending through an opening formed in the neck and trachea. The flanges 12 extend laterally and serve to allow a strap or retaining member (not shown) to hold the tube assembly in place on the patient. In the illustrated embodiment, apertures 30 are formed in each side flange 12 to allow the passage of such a retaining device. In many applications, the flange 12 may be taped or sutured in place as well.
The end connector 18 is formed in accordance with industry standards to permit and facilitate connection to ventilating equipment (not shown). By way of example, standard outer dimensions may be provided as indicated at reference numeral 32 that allow a mating connector piece to be secured on the connector shown. By way of example, a presently contemplated standard dimension 32 accommodates a 15 mm connector, although other sizes and connector styles may be used. In use, then, air or other gas may be supplied through the connector and the cannula 14, and gases may be extracted from the patient. For example, the tube assembly 10 may be inserted into the patient's airways, and the cuff 20 may then be inflated through an inflation lumen 34. A pilot balloon 36 may then indicate that air is in the cuff 20, thus sealing the patient's airway. Once the tracheal tube is positioned and secured, a ventilator may be coupled to the end connector 18 to provide for respiratory support.
Certain portions of the flange 12, as described in more detail below with respect to
The indentations 42 may be manufactured in an approximately circular shape, as depicted, or in other geometric shapes (e.g., squares, rectangles, triangles). Non-geometric shapes may also be used. By providing for the indentations 42, the portions 38 and 40 may be of lesser mechanical strength when compared to other portions (e.g., 44, 46) of the flanges 12. Accordingly, the clinician or user may comfortably fit the flanges 12 to a desired shape, for example, by cutting a desired shape at the portions 38 and/or 40, as described in more detail below with respect to
In the depicted embodiment, the portion 48 may have been removed, for example, for resizing purposes and/or to overcome obstructions in the neck area, such as a catheter (e.g., central venous catheter), sutures, a medical instrument (e.g., endoscope), anatomical protrusions, and so forth. While portion 38 is depicted as unexcised, a clinician or user may, of course, also remove a section of the portion 38. The clinician or user may then insert a strap or retaining member through the openings or apertures 30 to secure the tracheal tube assembly 10 to the patient's neck. In other embodiments, the lessened mechanical strength at portions 38 and or 40 may be provided by through holes or openings, as depicted in
In the illustrated embodiment depicted in
As mentioned above, the tracheal tube assembly 10 may be customized to fit a variety of anatomies and sizes, for example, by cutting at the portions 38 and 40 to reshape or customize the tracheal flange 12.
The cannula 14 may then be inserted into the trachea, and the flanges 12 may be positioned on the neck. A retaining member (not shown), such as a soft tie, may then be inserted through the apertures 30 and used to securely fasten the tracheal tube assembly 10 to the patient. In this manner, a more custom fit of the tracheal tube assembly 10 for a specific patient anatomy may be provided.
In an embodiment depicted in
Turning now to
In the illustrated embodiment, the flange members 60 and 62 include a rectangular protrusion 68 useful in securing the flange members 60 and 62 to the receiving members 64 and 66. The receiving members 64 and 66 include a receptacle 70 having a shape designed to receive or “mate” with the protrusion 68, as described in more detail below with respect to
In some embodiments, an audible noise, such as a click, may denote the secure engagement of the projections 72 inside the holes 74. In another embodiment, the projections 72 and holes 74 may not be used. In this embodiment, and interference fit or press fit created by coupling the flange member 60 to the receiving member 64 securely fastens the components 60 and 64 to each other. However, the interference fit may enable a clinician or user to apply a manual force suitable for separating the components 60 and 64. Accordingly, the clinician or user may manually attach or remove the flange member 60 from the receiving member 64, when desired.
In other embodiments, such as the embodiments show in
In other embodiments, such as the embodiments show in
During in situ assembly, the clinician or user may place the flange member 82 on top of the receiving member 64 so that the protrusion 84 is directly over the receptacle 86. The flange member 82 and receiving member 64 may then be manually pressed inwardly towards each other, for example, by using a thumb and an index finger, thus inserting the protrusion 84 into the receptacle 86. An interference fit between the flange member 82 and receiving member 64 may securely fasten the components 82 and 64 to each other. Additionally, projections, such as the projections 72 depicted in
The clinician or user may also manually attach or remove the flange member 92. For example, during in situ assembly, the clinician or user may place the flange member 92 on top of the receiving member 64 so that the protrusion 94 is directly over the receptacle 96. The flange member 92 and receiving member 64 may then be manually pressed inwardly towards each other, thus inserting the protrusion 94 into the receptacle 96. An interference fit between the flange member 92 and receiving member 64 may securely fasten the components 92 and 64 to each other. During removal, a manual force, such as the force 90 depicted as a normal vector to the force 88 may be applied, thus disengaging the flange member 92 from the receiving member 64. In this manner, the flange member 92 may be easily attached and/or removed from the receiving member 64.