Patent Application
20140261403
The present disclosure relates to a tracheal phonation techniques, and more particularly to a phonation enabled tracheal tube.
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 range of applications exist for artificial ventilation, which may call for the use of tubes that are inserted into a patient. Such tubes may include endotracheal tubes, tracheostomy tubes, and so forth. In the latter case, the tubes are typically inserted into an opening or stoma formed in the neck and trachea of the patient. In both cases, the tubes may be used for artificial ventilation or for assisting patient ventilation. The stoma is typically formed either surgically, through a procedure such as a cricothyroidotomy, tracheostomy, or through a micro-surgical procedure such as percutaneous dilation. A tracheostomy tube is then typically inserted through the stoma, and used to provide for an artificial conduit into the patient's respiratory system.
Once the tracheostomy tube is in place, phonation or verbalizing becomes somewhat difficult, particularly when cuffed tracheostomy tubes are used. For example, the tracheostomy tube and/or cuff may interfere with the movement of air through the tracheal region used for phonation, thus blocking intelligible speech. It would be beneficial to provide for a tracheal apparatus that enables phonation, thus resulting in improved speech.
The present disclosure provides for novel tracheostomy tubes that improve phonation. In one embodiment an external cannula or “grommet” tube (e.g., tube with retaining member on distal end) may be used. The external cannula includes features useful for long term placement inside of the stoma, including a reduced length cannula suitable for minimizing or eliminating protruding into the patient's airway. The external “grommet” tube may be placed for long term use, and may act as a guide for placing a first inner cannula having one or more inflatable cuff's into the patient's airway. In certain embodiments, the first inner cannula may be manufactured in similar geometries to a traditional outer cannula of a tracheostomy tube, and may similarly include one or more inflatable cuffs. A second inner cannula may then be disposed inside of the first inner cannula. The second inner cannula may be manufactured in geometries similar to a traditional inner cannula, thus enabling the placement of the second inner cannula co-axially inside of the first inner cannula. Accordingly, the tracheostomy tube assembly described herein may include three cannulae placed co-axially with respect to each other. However, because of the reduced length of the grommet tube, only the first and/or the second inner cannulae may protrude into the patient's airway.
During use, a medical device, such as a ventilator, may be fluidly coupled to an end connector of the grommet tube tracheal assembly, thus enabling an artificial circuit into the patient airway suitable for providing gases (e.g., air) and medicine. In cases where the first inner cannula includes one or more cuffs, the one or more cuffs may be inflated to create a seal between the outside of the first inner cannula and the tracheal walls. In this manner, substances can only flow into the patient airway through the tracheal tube assembly, enabling a medical practitioner to maintain control over the type and amount of substances flowing into and out of the patient. The second inner cannula may be a disposable cannula. Indeed, the second inner cannula may be removed and replaced as needed, for example, to eliminate secretion build-up that may have otherwise blocked fluid flow. When phonation is desired, both the first and second inner cannulae may be removed but the grommet tube may be left in situ, as described in more detail below. Because the grommet tube may only minimally protrude into the airway region, improved phonation may be enabled, even with the grommet tube is left in situ. Accordingly, the grommet tube may be left on the trachea for extended periods of time, thus maintaining the stoma opening.
Advantages 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 assembly according to a preferred embodiment is illustrated in
A first inner cannula 18 is illustrated extending both distally as well as proximally from the outer cannula 12. The first inner cannula 18 may be provided in different sizes, and may be introduced through an opening of a connector 20 of the outer cannula 12. Also depicted is a second inner cannula 22. In the depicted embodiment, the second inner cannula 22 is a disposable inner cannula that may be removed and replaced as desired, for example, to eliminate any secretions that may have accumulated in the second inner cannula 22.
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 24, although in practice a wide range of tube designs may be used, including tubes having no cuffs or tubes having multiple cuffs around the first inner cannula 18. The second inner cannula 22 in the illustrated embodiment forms a conduit from which liquids or gases, including medications, may enter through a proximal opening 26 an exit through a distal opening 28 of the second outer cannula 22. The first inner cannula 18 has an outer dimension 30 allowing it to fit easily through an incision made in the neck and trachea of the patient. In practice, a range of such tubes 12, 18, 22 may be provided in different lengths and diameters 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 30 of the tube 18 may range from 4 mm to 16 mm.
In one embodiment, the outer cannula 12 enters the flange member 14 along a lower face 32 and protrudes through an upper face 34 of the flange member 14. When in use, the face 32 will generally be positioned against the neck of a patient, with the cannula 12 extending through an opening formed in the neck and trachea. A pair of side wings or flanges 36 extend laterally and serve to allow a strap (not shown) to hold the tube assembly in place on the patient. In the illustrated embodiment, the apertures 16 are formed in each side flange 36 to allow the passage of such a retaining device. In many applications, the flange member 14 may be taped or sutured in place as well.
In the depicted embodiment, the first inner cannula 18 includes an end connector 38. The end connector 38 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 40 that allow a mating connector piece to be secured on the connector shown. By way of example, a presently contemplated standard dimension 40 accommodates a 15 mm connector, although other sizes and connector styles may be used. In use, then, air or other gas may be supplied to the patient through the tube assembly 10, flow into the patient through to the second inner cannula 22, 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 24 may then be inflated through an inflation lumen 42. A pilot balloon 44 may then indicate that air is in the cuff 24, thus sealing the patient's airway. Once the tracheal tube is positioned and secured, a ventilator may be coupled to the end connector 38 and used to establish an artificial airway.
When improved phonation is desired, both the first and the second inner cannulae 12 and 22 may be removed, leaving the outer cannula 12 in place on the patient's trachea and neck. Because the outer cannula 12 includes a reduced length, the outer cannula 12 may only minimally protrude into the patient's airway. Accordingly, airflow through the patient's airway may be modestly affected, if all. The improved airflow may thus provide for enhanced phonation and patient comfort. Indeed, the patient may be able to speak without undue strain or painful vocalization, even when the outer cannula 12 is left in place. While in the depicted embodiment the outer cannula 12 is illustrated as a straight tube, in other embodiments, such as the embodiments described in more detail below with respect to
In the depicted embodiment, the first inner cannula 18 includes an abutment member 48 disposed distal to the end connector 38. During insertion, the abutment member 48 may contact the connector 20 of the outer cannula 12, thus enabling a desired positioning of the first inner cannula 18 with respect to the outer cannula 12. Likewise, distal walls 50 of a connector 52 may contact the abutment member 48 during insertion of the second inner cannula 22, thus also enabling a desired positioning of the second inner cannula 22 with respect to the first inner cannula 18.
The outer cannula 12 may be selected to include certain properties, such as a preferred length l1 and an outer diameter (OD) d1. The length l1 may be selected to approximate a length lp of a tracheal passageway 45 used to insert the outer cannula 18 into the patient. The length l1 is measured from the distal opening 47 up to but not including the flange 14. In one usage case, the length l1 may be chosen to substantially approximate the length lp. In another usage case, the length l1 may be chosen to extend the outer cannula 12 slightly past the length lp. In this second usage case, a distal opening 46 of the outer cannula 12 may extend less than 5 mm, less than 4 mm, less than 3 mm, less than 2 mm, or less than 1 mm into the patient's airway and past the length lp. In yet another usage case, the length l1 may be selected to be slightly smaller than the length lp so that the outer cannula 12 does not protrude into the airway and instead remains fully inside the tracheal passageway 45. By only minimally protruding into the airway, or by remaining inside of the tracheal passageway 45, the outer tube 12 may only minimally interfere with airflow and phonation, if at all. By way of example, only the length l1 may be between 5 mm to 50 mm. In another example, a ratio of the diameter d1 to the length l1 may be between 1:0.5 to 1:5.
The diameter d1 may be selected to fit a variety of stoma sizes, including adult sizes, pediatric sizes, and neonatal sizes. By way of example only, the diameter d1 may be of between 2 mm to 20 mm. Likewise, the OD d2 may be selected so that the first inner cannula 18 may be disposed inside of the outer cannula 12, and the OD d3 may be selected so that the second inner cannula 22 may be disposed inside of the first inner cannula 18. That is, the OD d2 may be selected to be of a size equal to or smaller than an inner diameter (ID) 49 of the outer cannula 12, and the OD d3 may similarly selected to have a size equal to or smaller than an ID 51 of the first inner cannula 18.
In one embodiment, the length l2 may be provided to enable a more efficient respiratory circuit when the tracheal tube assembly 10 is disposed on the patient, while minimizing patient discomfort. Accordingly, l2 may include lengths of between 50 mm to 200 mm. The length l2 is measured as between a distal end (e.g., opening 28) of the tube 18 and the abutment member 48. Of course, other lengths may also be used. The length l3 of the second inner cannula 22 is usually chosen to correspond to the length l2. In some cases, the length l3 may be chosen to be greater than, or less than l2, depending on a desired application. The length l3 is measured as between a distal end (e.g., opening 28) of the tube 22 and proximal end the abutment member 48. In one embodiment, an interference fit or friction fit may be used to couple the cannulae 12, 18, and 22. In other embodiments described below, threads and/or snap connectors may be used to couple the cannulae 12, 18, and 22, in addition to or alternative to the use of interference fit couplings. As a way of example, the ratio of the length l1 to the length l2 or to the length l3 would be between 1:1.1 to 1:15.
Different techniques may be used to manufacture the tube assembly 10. The cannulae 12, 18, 22 and related components (e.g., flange 14, end connector 38) may be molded, overmolded, computer numerical control (CNC) machined, milled, or otherwise formed into their desired shapes. The tube assembly 10 components may be manufactured of materials such as a polyvinyl chloride (PVC), a PEBAX silicone, a polyurethane, thermoplastic elastomers, a polycarbonate plastic, a silicon, an acrylonitrile butadiene styrene (ABS), a polytetrafluoroethylene (PTFE). Once assembled, the tube assembly 10 may then be disposed inside of the trachea as shown in
In use, when the first inner cannula 18 is inserted into the outer cannula 12, the threads 68 and 72 may engage each other. Then, depending on the thread type used (e.g., right-turn threading, left-turn threading), clockwise turns of the first inner cannula 18 may move the first inner cannula 18 inwardly further into the outer cannula 12, and counter-clockwise turns of the first inner cannula 18 may move the first inner cannula 18 outwardly from the outer cannula 12, or vice versa. In some embodiments, such as the depicted embodiments, the threads 68 and/or the threads 72 may be disposed on partially on the walls 70 and 74, respectively. In other embodiments, the threads 68 and/or the threads 72 may be disposed on the entirety of the walls 70 and 74, respectively. By providing for threaded embodiments, the first inner cannula 18 may be more securely and easily positioned inside of the outer cannula 12.
In some embodiments, such as the embodiment shown in a side view of
In the depicted embodiment, an obturator 76 may be inserted through the outer cannula 12 so that an obturator tip 78 contacts an abutment member 80 of the inner cannula 18 and pushes the inner cannula 18 inwardly, for example, into the airway 58. An abutment member 82 may be disposed in the inner walls 70 of the outer cannula 18, and be used as a distal stop for the abutment member 80. Accordingly, the first inner cannula 18 may be disposed at a desired position with respect to the outer cannula 12. When the outer cannula 12 is disposed in the trachea 54 and it is desired to insert the inner cannula 18 into the outer cannula 12, the clinician may grasp a handle 84 of the obturator 76 and push inwardly in a direction 85 until the abutment members 80 and 82 contact each other. In this position, an interference fit or friction fit force may securely couple the first inner cannula 18 to the outer cannula 12. The second inner cannula 22 may then be inserted into the outer cannula 12 and the first inner cannula 18 as described previously and used to provide for a fluid conduit into the patient. When it is desired to remove the first cannula 18 from the outer cannula 12, a retracting member 86 may be used, as described in more detail below with respect to
As mentioned above, the second inner cannula 22 may then be disposed inside of the first inner cannula 18 and the outer cannula 12, and the resulting tracheal tube assembly 10 may then be used to provide for ventilation into the airway 58. Also as mentioned previously with respect to
Referring now to
Referring to
