Patent Application
20140014095
The present disclosure relates generally to the field of tracheal tubes and, more particularly, to a tracheal tube having an inner cannula indication system.
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. In general, two procedures are common for insertion of tracheostomy tubes, including a surgical procedure and a percutaneous technique.
Such tubes may include an inner cannula, such as a reusable inner cannula, or a disposable inner cannula. The inner cannula may be disposed inside the tracheostomy tube and used as a conduit for liquids or gas being exchanged with the patient's lungs. The inner cannula may be removed for cleaning and for disposal of secretions without disturbing the placement of the tracheostomy tube. A connector is typically provided at an upper or proximal end where the tube exits the patient's airway, suitable for coupling the ventilator with the inner cannula. In some products, the inner cannula may be removed, cleaned, and reused. In other products, the inner cannula may be disposable, and a new inner cannula may then be positioned inside of the tracheal tube. By enabling the cleaning and/or replacement of the inner cannula, a ventilation circuit may be kept clean and free of secretions.
Standard connectors have been developed to allow the tracheal tube to be fluidly coupled to artificial ventilation equipment to supply the desired air or gas mixture to the patient, and to evacuate gases from the lungs. One difficulty that arises in the use of tracheal tubes in general, and tracheostomy tubes in particular, is in the connection of the tube to the ventilation equipment. For example, an inner cannula may not be installed, or may be installed improperly, possibly leading to difficulties when a connection is made to ventilation equipment.
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.
As described in detail below, provided herein are tracheal tube assemblies including indication systems that indicate when the inner cannula is in an operable position with respect to the outer cannula. For example, in presently contemplated embodiments, the indication system may receive information regarding whether or not the respective positions of the cannulas place the tracheal tube assembly in an operable configuration. In certain embodiments, the received information regarding the cannula positions may originate from an operator. For instance, an operator may directly input such information to the indication system, for example, by sliding a device located on a flange (or other airway component) of the assembly from one position to another. In other embodiments, however, the indication system may receive such information electronically, for example, from an associated sensor system that senses the position of the inner cannula with respect to the other cannula. Still further, in certain embodiments, the indication system may communicate whether or not the inner cannula is in an operable position with respect to the outer cannula to another system. For example, the indication system may be communicatively coupled to a ventilation system, which utilizes the relative positional information for control, for example, of the exchange of fluid between a ventilator and an airway of a patient.
The provided tracheal tube assemblies may be disposable rather than reusable and may be capable of conveying gas to and from the patient, such as during medical situations that necessitate prolonged ventilation. As such, the devices and techniques provided herein may enable maintaining a bidirectional gas flow between the patient and an external ventilation device. Accordingly, the tracheostomy tube assemblies provided herein may be adapted to be inserted into the trachea via a surgical incision in the neck such that after insertion of the tube into the trachea, a portion of the tube remains outside the patient. This portion extends outwards from the neck and may connect the tracheostomy tube to a ventilator or other medical device. That is, the provided tracheostomy tube assemblies may be used in conjunction with auxiliary devices, such as airway accessories, ventilators, humidifiers, and so forth, which may cooperate with the tube assemblies to maintain airflow to and from the lungs of the patient. For example, the tracheal tubes may be coupled to an adapter or connector that is configured to couple the tracheostomy tube assemblies described herein to the desired auxiliary device.
Turning now to the drawings, a tracheal tube consistent with one embodiment is illustrated in
The outer cannula 14 is illustrated extending both distally as well as proximally from a flange member 16. The inner cannula 12 may be introduced through an opening 18 of an end connector 20 inside of the outer cannula 14. In the depicted embodiment, an inner cannula status indication system 21 having a status indicator 22 is provided. In the embodiment of
Regardless of its location, however, the status indicator 22 may enable a clinician or other user to easily identify whether the inner cannula 12 is properly placed with respect to the outer cannula 14. The foregoing feature may offer advantages over existing systems because the operator may easily identify that the cannula assembly is in an operable configuration, thus ensuring proper placement of the inner cannula 12 during use.
In the embodiments illustrated in
Still further, it should be noted that the status indicator 22 may be capable of conveying at least one parameter of the position of the inner cannula 12 with respect to the outer cannula 14 through a variety of suitable devices and systems. For example, in one embodiment, the status indicator 22 may be color coded, with each color indicating a different relative position of the cannulas with respect to one another. In such an embodiment, a first color (e.g., grey) may indicate that the tracheal tube assembly is not configured to receive an inner cannula, a second color (e.g., green) may indicate that the tracheal tube assembly is configured to receive an inner cannula and the cannulas are positioned in an operable manner with respect to one another, and a third color (e.g., red) may indicate that the tracheal tube assembly is configured to receive an inner cannula but the cannulas are not positioned in an operable manner with respect to one another. Still further, in other embodiments, the status indicator 22 may be an electronic display configured to communicate the respective position of the inner cannula to the user, for example, via visual or audio cues. Indeed, the forms that the status indicator 22 may take are specific to the application and are subject to a variety of implementation-specific considerations. The embodiments disclosed herein are merely examples.
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's 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 outer cannula 14. The inner cannula 12 in the illustrated embodiment Rains a conduit from which liquids or gases, including medications, may enter through the proximal opening 18 and exit through a distal opening 26. The cannula has an outer dimension 28 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 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 28 of the tube 20 may range from approximately 4 mm to approximately 16 mm in some embodiments.
In one embodiment, the outer cannula 14 enters the flange member 16 along a lower face 30 and protrudes through an upper face 32 of the flange member 16. When in use, the face 30 will generally be positioned against the neck of a patient, with the cannula extending through an opening formed in the neck and trachea. A pair of side wings or flanges 34 extend laterally and enable a strap or retaining member (not shown) to hold the tube assembly in place on the patient. In the illustrated embodiment, apertures 35 are formed in each side flange 34 to allow the passage of such a retaining device. In many applications, the flange member 16 may be taped or sutured in place as well.
In some embodiments, the outer cannula 14 may also include a suction lumen (not shown in
The end connector 20 is formed in accordance with industry standards to permit and facilitate connection to a ventilation system. By way of example, standard outer dimensions may be provided as indicated at reference numeral 36 that enable a mating connector piece to be secured on the connector shown. By way of example, a presently contemplated standard dimension 36 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 inner cannula 12, 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 38. In some embodiments, a pilot balloon 40 may then indicate that air is in the cuff 24, thus sealing the patient's airway. However, in other embodiments, the pilot balloon 40 may be eliminated, or the pilot balloon 40 may be utilized as one indication device, which is relied upon in part in combination with other indicators to determine when air is in the cuff 24. Once the tracheal tube is positioned and secured, a ventilator may be coupled to the end connector 20, as described in more detail below. By providing the status indicator 22 (or any of the variety of other indicators and indication systems described below), the tube assembly 10 may enable a more efficient ventilation circuit and reduce or prevent the likelihood of certain errors, such as ventilating the tube assembly 10 when the assembly is missing the inner cannula 12.
As mentioned above, the tracheal tube assembly 10 of
Additionally, as appreciated by one skilled in the art, it should be noted that the components of the tracheal tube assembly 10 may be formed from various suitable materials via any appropriate manufacturing process. For example, the end connector 20 may be manufactured of materials such as a polyvinyl chloride (PVC), a PEBAX silicone, a polyurethane, thermoplastic elastomers, a polycarbonate plastic, a silicon, or an acrylonitrile butadiene styrene (ABS). For further example, the inner and/or outer cannulas 12 and 14 may be formed from a soft polyvinyl chloride (PVC) or another suitable plastic (e.g., polyurethane, thermoplastic elastomers, etc.) through an extrusion process.
Still further, in certain embodiment, the end connector 20 and/or of the flange member 16 may be molded, overmolded, computer numerical control (CNC) machined, milled, or otherwise formed into the desired shape. In one embodiment, such as that which is shown in
In certain embodiments, the illustrated components may be provided as a tube assembly kit instead of in an assembled form. In such embodiments, the user or clinician may perform final assembly of the tracheal tube 10 by selecting a desired inner cannula 12 and then inserting the inner cannula 12 into the outer cannula 14 prior to intubation of the patient. More specifically, a distal end of the inner cannula 12 may be manually inserted inwardly into the outer cannula 14 through the opening 18. If the inner cannula 12 has been properly inserted, the status indicator 22 may activate a display, or otherwise communicate to the user that the inner cannula 12 is now in place with respect to the outer cannula 14. Once assembled in this manner, the tracheal tube 10 may then be inserted into the patient's trachea, and, during ventilation activities, the clinician may easily verify the presence of the inner cannula 12, as well as the position of the inner cannula 12 relative to the outer cannula 14.
For instance, in one embodiment, the indication system 21 may alert the ventilation circuitry 54 when the cannulas are positioned in an operative position, and the ventilation system 52 may then begin the exchange of fluid from the ventilation circuitry 54 with the airway of the patient through a contiguous passageway formed by the properly placed inner cannula 12 and the connector 20. Additionally, if desired in the given application, the indication system 21 may also display the operable status of the tube assembly to the operator via the display 50. Still further, in instances in which the positional sensing system 46 indicates that the cannulas are in an inoperable position, the ventilation system 52 may alert the operator to the presence of an error and/or may cease the exchange of fluid between the ventilator and the patient, again depending on implementation-specific considerations. Indeed, the relative position of the inner cannula 12 with respect to the outer cannula 14 may be utilized in a variety of downstream control schemes or algorithms to aid in the operation of the overall system if desired.
Still further, it should be noted that in some embodiments, the indication system 21 may be completely or partially automated, and in such embodiments, control circuitry 60 may be provided with or without associated memory, energy storage device(s), and so forth. In other embodiments, however, the indication system 21 may be configured as a manual system in which a user inputs the information regarding the position of the cannulas and makes a mechanical adjustment that communicates that information to a future user. In such a system, the control circuitry 60 and any other electronics may be eliminated.
The method 62 proceeds with an inquiry as to whether the position of the inner cannula 12 with respect to the outer cannula 14 is in the desired place (block 70). That is, a check may be performed to identify whether the cannulas are positioned in an operable or inoperable position, for example, within a preset positional tolerance. If the cannulas are not in an operable position, a second type of status indicator is displayed (block 72). For example, a second color, such as red, may be displayed to the operator to communicate to the operator that the assembly is not ready for operation. However, if the cannulas are in an operable position, a third type of status indicator (e.g., a green color) is displayed (block 74). In this way, the status of the inner cannula may be communicated to the clinician, or other end user.
While the disclosure may be susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and have been described in detail herein. However, it should be understood that the embodiments provided herein are not intended to be limited to the particular forms disclosed. Rather, the various embodiments may cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure as defined by the following appended claims.
