Patent Application
20130047993
The present disclosure relates generally to medical devices and, more particularly, to airway devices, such as tracheostomy tubes.
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.
In the course of treating a patient, a tube or other medical device may be used to control the flow of air, food, fluids, or other substances into the patient. For example, medical devices, such as tracheal tubes, may be used to control the flow of air and medicaments into or out of a patient's airway. In many instances, it is desirable to provide a seal between the outside of the tube or device and the interior of the passage in which the tube or device is inserted. In this way, substances can only flow through the passage via the tube or other medical device, allowing a medical practitioner to maintain control over the type and amount of substances flowing into and out of the patient.
More specifically, tracheal tubes may be used to control the flow of air or other gases through a patient's trachea. Such tracheal tubes may include endotracheal tubes or tracheostomy tubes. While patients may be intubated using endotracheal tubes during emergencies or shorter hospital stays, tracheostomy tubes are typically used for prolonged ventilation, as the use of a tracheostomy tube may be more comfortable for a patient.
A typical tracheostomy tube is generally inserted into the trachea via a stoma, which is a surgical incision in the neck. After insertion of the tube into the trachea, a portion of the tracheostomy 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. Generally, this exterior portion of the tube is held in place by a flange that rests on the patient's neck and is further secured by straps to the patient. The inserted portion of the tracheostomy tube is generally mechanically coupled to the flange, typically by a snap or screw mechanism or bonding on the underside of the flange, which rests on the patient's neck. During prolonged intubation periods, this mechanical connection point may cause irritation at the stoma site, thereby causing discomfort for the patient. Additionally, the portions of the flange that contact the patient's neck are often rigid, and, accordingly, when such portions rub against the patient's neck during movement of the patient, the patient may experience additional discomfort.
Certain devices attempt to address these problems by providing pillow or fabric protectors for the neck that may lift the flange slightly off the neck to avoid skin irritation, providing some additional comfort. However, these devices may be a less stable base for the tube at the patient's neck. Additionally, these devices often need to be replaced during periods of prolonged intubation, and it can be difficult for a medical practitioner to replace these devices since they are typically located between the flange and the patient's neck. Still further, during replacement, when the exterior portion of the tube (e.g., the flange) is shifted or moved, these movements may be translated to the interior potion of the tube. These movements may cause some additional discomfort for the patient if the tracheostomy tube shifts position within the trachea. Accordingly, there exists a need for tracheostomy tubes that overcome these drawbacks.
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.
As described in detail below, provided herein are tracheostomy tube assemblies including one or more flange members having a variable volume. For example, in presently contemplated embodiments, the flange member may be inflatable and capable of engaging a patient's neck to maintain a portion of the tracheostomy tube assembly outside of the patient's body. As compared to traditional designs, such tube assemblies may enable increased patient comfort during use. For example, as compared to conventional flanges that are often made of a relatively hard, inflexible material, the provided inflatable flanges may better conform to the patient's anatomy, possibly reducing or preventing the likelihood of discomfort at the stoma site. The foregoing feature may increase patient comfort since the allowed movement of the inflatable flange member, which rests against the patient's neck, may more closely follow patient movement as compared to traditional inflexible designs.
The provided tracheostomy 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,
In some embodiments, the cannula 12 may also include a suction lumen (not shown in
The tracheostomy tube assembly 10 also features a flange 28 having a variable volume and being connected to the proximal end 14 of the cannula 12. In the depicted embodiment, the flange 28 is an inflatable flange fluidly accessible via notch 30 coupled to inflation lumen 32. This lumen 32 is an airway that may be used to fill the inflatable flange 28. That is, during use, a medical practitioner may inject a suitable fluid, such as air, into the lumen 32 via inflation tube 34 and inflation assembly 36, thereby transferring the air to the inflatable flange 28. In this manner, the flange 28 may be inflated to a desired volume, which may be determined by the medical professional based on factors such as the patient's size, the tracheostomy tube size, and so forth. When inflated, the flange 28 is designed to rest on the neck of the patient to maintain a portion of the tracheostomy tube assembly 10 outside of the patient's body.
Features of the flange 28 having a variable volume and being illustrated in
In embodiments in which the variable volume flange is an inflatable flange, the walls of the flange 28 may be made of a polyurethane (e.g., Dow Pellethane® 2363-80A) having suitable mechanical and chemical properties. In other embodiments, the walls of the flange 28 may be made of silicone or a suitable polyvinyl chloride (PVC). In certain embodiments, the inflatable flange 28 may be generally sized and shaped as a high volume, low pressure cuff that may be designed to be inflated to pressures between approximately 15 cm H2O and 30 cm H2O. Additionally, in some embodiments, the wall thickness of the inflatable flange 28 may vary depending on the intended use of the tracheostomy tube assembly 10. Still further, in some embodiments, the flange 28 may not be inflatable, but instead, the flange 28 may be made of a material, such as foam, that is capable of expanding and contracting to various volumes. Additionally, it should be noted that the flange 28 may take on a variety of suitable shapes and sizes, not limited to the shapes of the depicted embodiments.
Additionally, the flange 28 may feature a conduit 38 that is substantially in-line with the proximal end 14 of the cannula 12. Generally, the conduit 38 may be adapted to connect the tracheostomy tube assembly 10 to any suitable medical device. For example, in certain embodiments, the conduit 38 may serve as an insertion point for a disposable cannula lining or may be suitably sized and shaped to connect the tracheostomy tube assembly 10 via medical tubing or other devices to a mechanical ventilator.
In the depicted embodiment, the tracheostomy tube assembly 10 also includes an inflatable cuff member 40 disposed about the cannula 12. During use, the cuff member 40 is adapted to be inserted into the patient's trachea and to remain within the patient's airway throughout the period of ventilation of the patient. More specifically, the cuff member 40 may be inserted into the patient's airway in a deflated state and subsequently inflated when the tracheostomy tube assembly 10 is appropriately positioned. To that end, a notch 42 coupled to an inflation lumen 44, an inflation tube 46, and an inflation assembly 48 enable a user to insert air into the cuff member 40 to inflate the cuff member 40 to the desired volume within the patient's trachea. In the depicted embodiment, the inflatable flange 28 and the cuff member 40 are designed to be inflated on opposite sides of the stoma, thereby securing the tracheostomy tube assembly 10 in the desired position, as discussed in more detail below with respect to
Turning now to
Likewise, the inflatable flange 28 is illustrated in an inflated state, for example, after the medical practitioner has inflated the flange 28 to the desired volume for the given application. Still further, in the depicted embodiment, a stoma pad 56 is positioned between the flange 28 and the tracheal wall 52 to decrease patient discomfort due to irritation of the stoma. In certain embodiments, the inflatable flange 28 may offer advantages over rigid flanges having a predetermined volume because the inflatable flange 28 may be deflated and re-inflated during the intubation period as desired. For example, in instances of prolonged ventilation, it may be desirable to remove and replace the stoma pad 56. By varying the volume of the flange 28 between a fully inflated state and a partially or completely deflated state, the stoma pad 56 may be more easily removed and replaced with a reduced level of discomfort experienced by the patient.
Still further, when inflated and positioned as illustrated, the flange 28 exerts pressure on the stoma pad 56, and the cuff member 40 exerts pressure on the tracheal wall 52. In this manner, the stoma pad 56 and the tracheal wall 52 become compressed between the flange 28 and the cuff member 40, and the tracheostomy tube assembly becomes secured in the patient's trachea. The foregoing feature may reduce or eliminate the desirability of including the cuff 22 on the cannula 12 in some embodiments. However, if desired, the cuff 22 may also be provided to center or otherwise position the cannula 12 within the trachea 50.
Still further, it should be noted that although in the illustrated embodiments, the cuff member 40 is coupled to a cannula that includes the inflatable flange member 28, in other embodiments, the cuff member 40 may be utilized in conjunction with other variable or constant volume flanges. For example, in one embodiment, the cuff member 40 may be utilized with a traditional rigid flange member. In these embodiments, the stoma pad 56 and the tracheal wall 52 may be compressed between the conventional, rigid flange member and the cuff member 40 to secure the tracheostomy tube assembly in the patient.
To facilitate insertion of the cannula 12 into the patient's trachea 50, it may be desirable to maintain the cuff member 40 in a deflated position until the cannula 12 is advanced beyond the stoma site 58.
In some embodiments, the medical practitioner may verify that the cuff member (e.g., cuff member 40) is substantially deflated (block 66). Again, the cuff member may be designed for positioning within the patient's trachea when the cannula is in its fully inserted position. The patient may then be intubated with the tracheostomy tube assembly having the cuff member in a deflated state (block 68). Once the cannula is inserted to the desired position, the cuff member is inflated to the desired volume (block 70), and the tracheal wall becomes compressed between the exteriorly located flange and the interiorly located cuff member. If the medical practitioner desires to remove the tracheostomy tube assembly from the patient's trachea, the cuff member may be deflated (block 72), and the tracheostomy tube may be removed from the patient's airway (block 74).
To enable independent inflation of each of the inflatable regions 80 and 82, inflation lumens 84 and 86 are provided. Specifically, a user may insert air into inflatable region 80 via notch 88, inflation lumen 84, inflation tube 90, and inflation assembly 92. Similarly, a user may insert air into inflatable region 82 via notch 94, inflation lumen 86, inflation tube 96, and inflation assembly 98. As such, the two inflation regions 80 and 82 may be inflated or deflated to the desired volumes.
It should be noted that based on the intended use of the tracheostomy tube assembly, a different arrangement or quantity of inflatable regions may be provided. The inflatable flanges and/or cuff members of presently disclosed embodiments may take on various forms having a variety of arrangements of inflatable regions. For example, embodiments of the inflatable flanges and/or cuff members may have any combination of any quantity of vertically, horizontally, or angularly disposed inflatable regions, such as regions arranged in a honeycomb structure, among other desirable structures.
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.
