Abstract:
A retainer is provided comprising a ring configured to fit over a readily available tracheostomy tube and be securable thereto, and further having cooperating straps configured to extend around and secure an auxiliary device coupled to the tracheostomy tube, such as a ventilator tube. The retainer is configured to be selectively and easily attachable to existing tracheostomy tubes to provide a platform for securing an auxiliary device.

Description:
BACKGROUND OF THE INVENTION 
   1. Field of the Invention 
   The current invention relates to medical devices, and more specifically, to a securement device for inhibiting unintentional disconnection of an auxiliary device attached to a tracheostomy tube. 
   2. Description of the Related Art 
   Tracheotomy is a surgical procedure in which an incision, called a tracheostomy, is made into the trachea through the neck tissues that forms a temporary or permanent opening, called a stoma. A tracheostomy tube is inserted through the opening to allow passage of air and removal of secretions. The tracheostomy tube allows air to flow through the tube and into the patient&#39;s lungs and further allows passage of other medical instruments into the trachea and connected organs. 
   Once the tracheostomy tube has been inserted it is important that the position of the tube be stabilized such that it is not inadvertently withdrawn from the trachea, and such that the tube is otherwise positioned to function properly. Currently, tracheostomy tubes typically have a laterally extending flange surface configured to extend parallel to the front portion of the patient&#39;s neck when the tube is installed. The flange generally has two slots for connecting with a strip or band to encircle the patient&#39;s neck to hold the tracheostomy tube securely in place. 
   Oftentimes, an auxiliary device is connected to the tracheostomy tube. Such auxiliary devices are desirable for monitoring a patient&#39;s breathing or for aspirating secretions. It is desirable that any auxiliary device remains securely attached to the tracheostomy tube to inhibit inadvertent separation. This is especially important with young children who may attempt to remove such auxiliary devices. Moreover, it is advantageous to secure the auxiliary devices during sleep periods, during which a patient may inadvertently disconnect the auxiliary device. 
   SUMMARY OF THE INVENTION 
   It is therefore an object of the present invention to provide a simple device that is easily attachable to current tracheostomy tubes and collars and which is configured to securely attach an auxiliary device to a tracheostomy tube. The present invention results, in part, from the realization that many current tracheostomy tubes are configured with a generally round tube and have a laterally extending flange surface configured with slots designed to receive the straps of a collar to secure the tracheostomy tube to a patient&#39;s neck. By taking advantage of the typical structure of modem tracheostomy tubes, embodiments of the present invention are configured to be used with a wide variety of tracheostomy tubes and provide the added advantage of securing an auxiliary device to a readily available tracheostomy tube. 
   According to one embodiment, an apparatus is provided for securing an auxiliary device to a tracheostomy tube. The apparatus comprises a ring having a pair of opposed extensions defining strap holds, and further having a pair of secondary strap holds. A void within the ring is configured to allow passage of a tracheostomy tube through the right. A pair of auxiliary device straps are affixed to each of the secondary strap holds, the auxiliary straps configured so that, when the tracheostomy tube extends through the rnig void, the auxiliary straps extend around an auxiliary device that is fit onto the tracheostomy tube so as to maintain a maximum spatial relationship between the auxiliary device and the ring. The auxiliary device straps can be configured with fastening elements to releasably secure the auxiliary device straps together, such as hook and loop fastener, for example. A tracheostomy collar can be provided having a neck strap and the ring can be secured to the tracheostomy collar by the neck strap. In one embodiment, the neck strap connects to the tracheostomy collar and the, strap holds of the ring. In some embodiments, the ring has a major axis extending between the strap holds and a minor axis extending between the secondary strap holds, and the major axis is greater than the minor axis. 
   According to another embodiment, a method of securing an auxiliary device to a flanged tracheostomy tube comprises the steps of providing a flanged tracheostomy tube; providing an auxiliary device; providing a tracheostomy collar having a neck strap; providing a retainer configured to fit over the tracheostomy tube, the retainer having a retainer strap configured for releasable engagement with the auxiliary device, and further having two or more strap holds configured to receive the neck strap; fitting the retainer over the tracheostomy tube; securing thee neck strap to the flanged tracheostomy tube and to the retainer thereby securing the retainer to the tracheostomy tube; engaging the auxiliary device with the tracheostomy tube; and securing the retainer to the auxiliary device with the retainer strap. Optionally, the neck strap can pass through slots on the tracheostomy tube and also pass through the strap holds on the retainer. In addition, the method can further comprise the step of fastening a pair of retainer straps having a hook and loop fastening closure around the auxiliary device. Finally, the neck strap can connect to both the tracheostomy tube and the strap holds. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
       FIG. 1  illustrates a perspective view of one embodiment of a tracheostomy tube and a collar. 
       FIG. 2  is a plan view of one embodiment of a securement device for use with a tracheostomy tube. 
       FIG. 3  is a perspective view of the securement device of  FIG. 2  engaging a tracheostomy tube. 
       FIG. 4  shows the arrangement of  FIG. 3  and further shows the securement device engaging an auxiliary device connected to the tracheostomy tube. 
       FIG. 5  is a plan view of an additional securement device embodiment. 
       FIG. 6  is a plan view of an additional securement device embodiment. 
       FIG. 7  is a plan view of another securement device embodiment. 
       FIG. 8  is a plan view of yet another securement device embodiment. 
   

   DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
   In the following description, reference is made to the accompanying drawings which form a part of this written description which show, by way of illustration, specific embodiments in which the invention can be practiced. It is to be understood that other embodiments may be utilized and structural changes may be made without departing from the scope of the present invention. Where possible, the same reference numbers will be used throughout the drawings to refer to the same or like components. Numerous specific details are set forth in order to provide a thorough understanding of specific embodiments; however, it is to be understood that the present invention may be practiced without the specific details or with certain alternative equivalent devices and methods to those described herein. In other instances, well-known methods, procedures, components and devices have not been described in detail so as not to unnecessarily obscure aspects of the present invention. 
     FIG. 1  illustrates a typical, commercially available tracheostomy tube  10  and a collar  20  designed to hold the tracheostomy tube  10  in place. The tracheostomy tube (“trach tube”) generally comprises a down tube  22  and an out tube  24  connected by an elbow  26 . Typically, the down tube  22 , out tube  24 , and elbow  26  are of unitary construction, however, it is conceivable that these components could be separate and connected to form a trach tube. A flange  30 , which is also typically formed integral with the trach tube, extends from the out tube  24  and defines a generally planar surface extending perpendicular to the out tube  24 . The typical flange  30  defines two apertures  32 ,  34 . As used herein, the terms tracheostomy tube, trach tube, and endotracheal tube are used interchangeably and all refer to a device configured to reside at least partially within a patient&#39;s trachea and to provide a conduit for breathing, and are used in their broadest sense. 
   With continued reference to  FIG. 1 , the collar  20  typically comprises a neck band  40  and one or more straps  42  configured to attach the collar  20  to the flange  30  at the flange apertures  32 . In many available collars  20 , the straps  42  are flexible and oftentimes formed of a resilient material. They may be secured to the flange  30  in any of a number of methods; however, one common method secures a collar  20  to a trach tube flange  30  by passing the straps  42  through the flange apertures  32 , and then fastening the strap  42  either to itself, or to another portion of the collar  20 . The strap  42  is often fastened by configuring the neck strap  42  with hook and loop fastener. Of course, other methods of securing the collar  20  to the flange  30  are possible, such as by using tie strings, snaps, or other suitable releasable fastening connectors. 
   When worn by a patient, the flange  30  usually rests against the patient&#39;s neck and thereby stabilizes the trach tube  10  from unintentional movement, which can cause discomfort to the patient. Moreover, during installation, the trach tube  10  is inserted until the flange  30  rests against the patient&#39;s neck which provides for repeatable placement. The neck strap is preferably configured to maintain the trach tube  10  in its desired position. 
   Oftentimes, it is desirable or necessary to attach an auxiliary device  50  to a trach tube  10 . The auxiliary device  50  may be any of a number of useful devices, such as, for example, a ventilation tube, a heat or moisture exchanger, a filter, or the like. The auxiliary device  50  typically comprises an attachment portion  52  configured to engage the out tube  24 . The auxiliary device  50  attachment portion  52  may be configured as a cylinder with a diameter slightly larger than the out tube  24  such that the attachment portion  52  may slide engagingly over the out tube  24 . In many cases, the auxiliary device  50  is attached by friction. However, it is desirable in certain circumstances to secure the auxiliary device  50  to the trach tube  10  by a more secure device and method. 
   Referring to  FIG. 2 , one embodiment of a tracheostomy tube attachment securing device, or retainer  60 , is shown. In the illustrated embodiment, the retainer  60  comprises a generally circular ring  62 , an upper strap  64 , and a lower strap  66 . As used herein, the term “ring” is a broad term and is used to describe any regular or irregular peripheral shape that defines an opening through its center. For example, a ring may be shaped as a circle, oval, rectangle, oblong, or any other regular or irregular shape. Moreover, a ring need not define a closed shape, but also includes open configurations, such as U-shaped or C-shaped configuration. In addition, the term “ring” also includes shapes that are selectively configurable, such as having a hinge, or one that is separable into two or more pieces. Likewise, the term strap is a broad term and is used herein to refer to any device that extends from the ring and is configured to secure, engage, be attached to, or otherwise hold onto another component. 
   The ring  62  illustrated in  FIG. 2  defines a closed shape and generally defines a circle having two lateral extensions  68 ,  70 . The interior of the ring  62  is configured with a void  72  dimensioned to allow a tracheostomy tube  10  to pass therethrough. The void  72  is further configured to cooperate with the lateral extensions  68 ,  70  to provide strap holds  74 ,  76 . In addition, the void  72  cooperates with the ring  62  to define secondary strap holds  78 ,  80  configured to accommodate the upper strap  64  and the lower strap  66 . In the illustrated embodiment, the upper strap  64  and the lower strap  66  are permanently attached to the ring  60 . In one embodiment, the upper strap  64  passes through the void  72  and is then affixed to itself, such as by sewing, adhesives, or other mechanical or chemical bonding. The lower strap  66  is similarly attached to the ring  62 . In other embodiments, the upper strap  64  and lower strap  66  are selectively removable from the ring  62 , and may be attached through a releasable connection, such as hook and loop fastener. 
   The strap holds  74 ,  76  are preferably configured to allow a neck strap  42  provided with a standard tracheostomy collar  20 , such as the one illustrated in  FIG. 1 , to engage the strap holds  74 ,  76  without causing the neck strap  42  to crease or fold. In one embodiment, this is accomplished by forming the strap holds  74 ,  76  to be at least the width of a standard neck strap  42  found on traditional tracheostomy collars  20 , which allows the neck strap  42  to lay substantially flat through the strap holds  74 ,  76  without folding or creasing. 
   The ring  62  may be formed of any suitable material, such as polymers, metals, composites, or combinations thereof, and by any suitable method, such as injection molding or machining. In one preferred embodiment, the ring  62  is injection molded of a suitable polymer, such as polyethylene or polyurethane, for example. The upper strap  64  and lower strap  66  can be formed of any suitable material, such as nylon, plastic, or any other suitable textile or polymeric material. Of course, other materials for the various components will be readily apparent to those of skill in the art and the scope of the invention should not be limited to those specific materials or manufacturing processes disclosed herein. 
   Referring to  FIG. 3 , the retainer  60  is illustrated secured to the trach tube  10 . With the trach tube  10  inserted into the patient, the retainer  60  is slipped over the out tube  24 . Referring to a first side  81  of the assembly, the neck strap  42  first passes through the flange aperture  32  by being inserted from the back of the flange  30  and exiting the front of the flange  30 . The neck strap  42  then passes through the retainer void  72  from the rear of the retainer  60  and is then secured in any suitable manner. As discussed above, many tracheostomy collar neck straps  42  are secured by hook and loop fastener, snaps, or otherwise. However, for convenience, the remainder of this disclosure will use hook and loop fastener as an example. Once the neck strap  42  passes through the retainer  60 , it engages the strap hold  74 , which presents a substantially flat surface to inhibit the neck strap  42  from bending or folding along its longitudinal length. The neck strap  42  may be optionally routed back through the flange aperture  32 , or it may simply pass over the flange  30  before it is secured. After the neck strap  42  has been routed through the flange aperture  32  and the retainer  60 , it is tensioned appropriately and is secured to itself by hook and loop fastener. 
   The second side  83  of the assembly is configured in substantially the same way, with the neck strap  42  passing first through the flange aperture  34  from the back of the flange  30  and exiting the front of the flange  30 . The neck strap  42  then passes through the void  72  from the back of the retainer  60  and exits the front of the retainer  60 . The neck strap  42  can then either pass over the retainer  60  and flange  30  and be secured as illustrated in  FIG. 3 , or it may pass over the retainer  60  and back through the flange aperture  34  before it is secured. Thus, with the neck strap appropriately tensioned and secured, the neck strap  42  exerts a force on the retainer  60  that urges the retainer against the flange  30 , thereby keeping the flange  30  against the patient. 
   As can be seen, the neck strap  42  passes through the flange apertures  32 ,  34  and can hold the flange  30  even in the absence of the retainer  60  as illustrated in  FIG. 1 . Hence, the neck strap  42  holds the flange  30  firmly in place whether or not the retainer  60  is present. Thus, a significant advantage of described embodiments is that the retainer  60  can be added and removed from a commercially available assembly quickly and easily and without requiring the addition or removal of additional components. For example, with a typical tracheostomy tube  10  and flange  30  as illustrated in  FIG. 1 , the addition of the retainer  60  described herein merely requires a user to (1) release a first strap  42  and pass it through the first strap hold  74  of the retainer  60  and reattach the strap  42 , (2) release the second strap  42  and pass it through the second strap hold  76  and reattach the strap, and (3) place the retainer over the trach tube  10 . Of course, the listed steps do not need to be performed in the described order. For example, the retainer  60  may be placed over the trach tube  10  first and then the straps  42  can be routed through the strap holds  74 ,  76  before being reattached. The straps  42  are preferably configured as described herein to allow efficient attachment and removal to allow quick and easy attachment and removal of the retainer  60 , as desired. 
   Referring to  FIG. 4 , an auxiliary device  50  is shown attached to the trach tube  10 . Although the illustrated auxiliary device  50  is shown friction fit over the out tube  24 , the auxiliary device  50  may be attached in any suitable manner. Once the auxiliary device  50  is connected to the trach tube  10  in a suitable manner, the upper strap  64  and lower strap  66  pass around the auxiliary device  50  and connect to one another. In the illustrated embodiment, the upper strap  64  and lower strap  66  are configured with hook and loop fastener and cooperate to securely grasp one another and hold the auxiliary device  50  in its attached configuration. Of course, in other embodiments, the upper strap  64  and lower strap  66  could be suitably configured with any type of fastening mechanism to allow the upper strap  64  and lower strap  66  to releasably and securely hold the auxiliary device  50  in its attached configuration. Alternatively, a single strap could be used to pass around the auxiliary device  50  and then connect to the retainer  60 . 
   As an additional feature to securing the auxiliary device  50 , once the upper strap  64  and lower strap  66  are appropriately tensioned about the auxiliary device  50 , the straps  64 ,  66  oppose rotation of the auxiliary device about the trach tube  10 . This further enhances the connection and inhibits undesirable movement. 
   As thus described, one embodiment of the retainer  60  is securely held against the trach tube flange  30  by the neck straps  42 . In turn, the auxiliary device  50  is held to the trach tube  10  by the retainer  60  auxiliary straps  64 ,  66 . Thus, in some embodiments, the auxiliary device  50  is connected to the flange  30  via the retainer  62  and can be attached or disconnected without disturbing the flange  30 . 
     FIG. 5  illustrates an additional embodiment of a retainer  60  having a ring  62 , a void  72  defined within the central portion of the ring  62 , lateral strap holds  74 ,  76  secondary strap holds  78 ,  80 , and an upper strap  64  and a lower strap  66 . In this embodiment, the ring is generally circular in shape and also defines a generally circular void  72 . The void is preferably configured to allow passage of a trach tube  10  therethrough. The ring  62  defines a thickness between a front surface and a back surface. In one embodiment, the ring thickness is within the range of from about 0.0625 inches to about 0.125 inches or more. 
   The strap holds  74 ,  76  are defined by apertures formed through the ring  62 . Likewise, the secondary strap holds  78 ,  80  are also formed by apertures through the ring  62 . In some embodiments, the void  72  is specifically shaped to cooperate with a specific trach tube  10 . For example, a trach tube can be configured with an annular ridge spaced away from the flange  30 , in which case, the retainer  60  can be specifically configured with a void  72  that passes over the trach tube  10  but interferes with the ridge to space the retainer  60  away from the flange  30  a desired distance. 
     FIG. 6  illustrates an additional embodiment of a ring  62  for use as a retainer  60  according to embodiments described herein. The ring is generally oval, or oblong, in shape. As such, the strap holds  74 ,  76  are spaced further apart than the secondary strap holds  78 ,  80 . Such a configuration can be advantageous to influence the direction of forces acting on the ring because the spacing of the strap holds  74 ,  76  directly influences the magnitude of the force tending to urge the ring against the trach tube flange. In addition, spacing the strap holds  74 ,  76  allows for easier installation and removal of the retainer  60 . 
   The tensioned neck strap  42  imparts a force onto the ring  62  that urges the ring  62  against the trach tube flange  30 . Given a constant tension on the neck strap  42 , the force is at a maximum when the neck strap  42  exerts a force in which the force vector is directly toward the trach tube flange  30 , i.e. perpendicular to the plane of the flange  30 . The force approaches zero as the force vector approaches a direction that is parallel to the plane defined by the front surface of the ring  62  and therefore only minimally urges the ring  62  against the trach tube flange  30 . The direction of the force vector is controlled, in part, by the configuration of the ring  62 . 
   As the ring  62  is reduced in size, such that the strap holds  74 ,  76  approach one another, the neck strap  42  is required to wrap more fully around the wearer&#39;s neck. As such, the neck strap  42  approaches the ring  62  from a direction that is nearly parallel to the plane of the ring  62 , and thus, the force vector is likewise nearly parallel to the plane of the ring  62 . Likewise, as the strap holds  74 ,  76  are spaced further apart, the neck strap  42  need not wrap completely around a wearer&#39;s neck and thus, approach the ring  62  from a direction that is perpendicular to the plane of the ring. For example, when the distance between the strap holds  74 ,  76  is equal to the diameter of a wearer&#39;s neck, the neck strap  42  will approach the ring at a direction that is directly perpendicular to the ring  62 , and the force will reach a maximum. The above example assumes a flat, planar, ring, and is used for illustrative purposes only and not limiting. Of course, the ring  62  could be contoured to approximate the curvature of a wearer&#39;s neck, or otherwise curved so that it does not lie in a single plane. 
   As discussed above, spaced apart strap holds  74 ,  76 , will apply a greater holding force urging the ring  62  against the flange  30  than if the strap holds  74 ,  76  are close together. However, in some preferred embodiments, the ring  62  is preferably not substantially larger than the trach tube flange  30 . 
   It is desirable that the ring  62  not cause an excessive amount of discomfort to the patient. Thus, in some preferred embodiments, the height h of the ring is less than or equal to the height of the trach tube flange  30  so as to not further interfere with patient movement any more than the trach tube  10  alone. 
   With these considerations in mind, some preferred embodiments incorporate a ring  62  that distances the strap holds  74 ,  76  farther than the secondary strap holds  78 ,  80 . In these embodiments, a major axis extends between the strap holds  74 ,  76  while a minor axis extends between the secondary strap holds  78 ,  80 , with the major axis being greater than the minor axis. Some preferred ring shapes are oblong, oval, or rectangular in shape. Of course, the outer shape of the ring  62  may be circular or square and the void  72  can be configured to produce the desired spacing of the strap holds  74 ,  76 . For example, with reference to  FIG. 2 , the ring  62  is substantially circular in shape and the configuration of the void  72  defines the spacing between the strap holds  74 ,  76  and the secondary strap holds  78 ,  80 . 
     FIGS. 7 and 8  illustrate yet additional embodiments of a ring  62  that can be used with the retainer described herein. In these additional embodiments, each ring  62  defines lateral extensions  68 ,  70  extending away from an otherwise circular or oval ring  62 . Each embodiment further defines a top extension  84  and a lower extension  86  protruding from the ring  62 . In each embodiment, the void  72  closely tracks the outer shape of the ring  62 . The size of the void  72  will materially affect the strength of the ring  62 , and hence, the ring  62  is preferably designed to withstand forces during normal use. 
   Although this invention has been disclosed in the context of certain preferred embodiments and examples, it will be understood by those skilled in the art that the present invention extends beyond the specifically disclosed embodiments to other additional embodiments and/or uses of the invention and obvious modifications and equivalents thereof. For example, while a few examplary embodiments have been shown and described herein, it will become readily apparent to those of skill in the art that several different ring shapes are capable of being used in conjunction with the claimed invention. In addition, while a number of variations of the invention have been shown and described in detail, other modifications, which are within the scope of this invention, will be readily apparent to those of skill in the art based upon this disclosure. It is also contemplated that various combinations or subcombinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the invention. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the disclosed invention. Thus, it is intended that the scope of the present invention herein disclosed should not be limited by the particular disclosed embodiments described above, but should be determined only by a fair reading of the claims that follow.