Patent Publication Number: US-2007107723-A1

Title: Pediatric tracheostomy mask

Description:
BACKGROUND OF THE INVENTION  
      This invention relates generally to the field of medical respiratory devices encompassing devices that create an enclosed area about breathing orifices for the delivery of gases, vapors, treatment mists or the like to the breathing orifices without the need for insertion of tubes into the orifices, and more particularly to the field of such devices that are used in conjunction with tracheostomies.  
      Patients with respiratory obstructions that interfere with normal breathing are often treated with tracheostomy surgery to provide an opening or stoma through the neck and into the trachea whereby a tracheostomy tube can be inserted to create an alternative breathing passageway. The tube also allows for mechanical ventilation, removal of tracheobronchial secretions, access of instrumentation, delivery of medicine and other procedures. Because the body has no means to naturally moisten the air being delivered through the tube, it is desirable to provide a means to moisten the air prior to it being breathed by the patient.  
      The common solution to this problem is by the use of a tracheostomy mask that is positioned over the tracheal opening, the mask being held in place by an elastic strap that encircles the patient&#39;s neck. The mask is connected to a source of moist air, such as a nebulizer. Typically, the mask comprises a soft, flexible main body with a relatively rigid tubular adaptor joined to the soft body in a manner that allows the tubular adaptor to swivel or rotate such the angle of the tubular adaptor and the connected tube from nebulizer can be altered relative to the patient. An exhaust opening is provided such that exhaled air may exit from the mask. Examples of tracheostomy masks are seen in U.S. Pat. No. 3,236,236 to Hudson, U.S. Pat. No. 3,824,999 to King, U.S. Pat. No. 5,485,837 to Solesee et al., U.S. Pat. No. 5,749,360 to Lacey et al., and U.S. Pat. No. 6,698,426 to Wright.  
      Because the tracheostomy mask is positioned on the neck of the patient directly beneath the chin, a problem can arise in that the exhaust opening may be inadvertently obstructed by the patient&#39;s chin. This is a particular problem in relation to pediatric tracheostomy masks, where the mask is by necessity relatively small in dimension. This potential obstruction problem is especially exacerbated with infants due to the fact that the neck muscles and the ability to control the neck muscles may not be sufficiently developed. To address this, the infant&#39;s neck may be secured in a hyper-extended position or large cage-like cover guards may be used. Other problems encountered with traditional tracheostomy masks used in pediatric applications is that the masks can produce pressure sores.  
      It is an object of this invention to provide a tracheostomy mask for pediatric use that solves the problems set froth above, in that the structural design of the mask minimizes or eliminates the potential for obstruction of the exhaust opening, minimizes or eliminates pressure sores, and provides an improved position for the tubular adaptor relative to the main body of the mask such that a greater range of rotation of the tubular adaptor is present. These objects and other objects not expressed at this time will be readily apparent from the disclosure to follow.  
     SUMMARY OF THE INVENTION  
      A pediatric tracheostomy mask for use with infants and small children, the mask comprising a soft and flexible main body forming a three-dimensional, cup-like area that defines an enclosed area of sufficient size to encompass a tracheostomy opening, a soft, flexible flange member for contacting the patient&#39;s skin, a pair of lateral wing members, and a strap attached to the wing members for securing the mask to a patient. The mask further comprises a generally hemispherical, relatively rigid, rotating connector member for connecting a tubular adapter member to the mask, the connector member being mounted to the main body such that the connector member can be rotated about its central axis. The connector member is provided with multiple exhaust apertures in the form of slits. The tubular adaptor comprises an extended linear tube portion with an annular lip at its free end, an elbow portion and a short linear tube portion with a mounting flange for connection to the connector member. The tubular adaptor is rotatably mounted to the connector member.  
      The flange member is provided with a recess along the upper surface of the main body such that the flange member curves toward the front of the mask. A depression is provided in the upper surface of the main body extending forward from the flange recession. The lowermost point of the junction between the tubular adaptor and the connector member is elevated in comparison to typical masks, with the point of connection being at a point from the bottom of the main body approximately one quarter or more of the overall height of the main body. The plane of rotation of the tubular adaptor is approximately 45 degrees relative to the plane of rotation of the connector member. Preferably, the mask is provided in the shape of an elephant or other animal so as to reduce anxiety of both the patient and the parents.  
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       FIG. 1  is a perspective view of a preferred embodiment of the tracheostomy mask of the invention.  
       FIG. 2  is a front view.  
       FIG. 3  is a top view.  
       FIG. 4  is a side view.  
       FIG. 5  is a cross-sectional view taken along line V-V of  FIG. 2 , with a portion of the recess and depression features shown for clarity.  
    
    
     DETAILED DESCRIPTION OF THE INVENTION  
      With reference to the drawings, the invention will now be described in detail with regard for the best mode and the preferred embodiment. In general, the invention is an improved pediatric tracheostomy mask, that is, a mask that creates an enclosed environment about the exit port of a tracheostomy tube such that moistened air can be provided for breathing, and one which is down-sized so as to be appropriate for use with infants and small children. The improved pediatric tracheostomy mask provides a better fit to the infant or small child, reduces the likelihood that the exhaust openings will be obstructed by the patient, and provides a more optimum positioning of the tubular adaptor member that connects to the outlet hose of a nebulizer or similar equipment.  
      For purposes of this disclosure, directions shall be referenced from the orientation of the mask  10  as being attached to a patient sitting, standing or being held upright in a generally vertical manner, such that the front of the mask  10  extends away from the patient and the rear of the mask is in contact with the patient&#39;s neck. Likewise, the top of the mask shall mean the uppermost surface facing the chin of the patient and the bottom of the mask shall mean the lowermost surface facing in the direction of the patient&#39;s torso. In particular in this disclosure, true vertical shall be taken to mean the plane of rotation of the connector member  21  relative to the main body  11  of the mask  10 .  
      As shown in the figures, the invention is a pediatric tracheostomy mask  10  comprising in general a main body  11 , lateral wing members  12 , a strap member  13 , a rotating connector member  21  and a rotating tubular adaptor member  31 . The main body  10  is composed of a soft, flexible plastic and is formed in a three-dimensional, generally cup-like configuration such that the rear of the main body  11  presents a large open area  14 . The open rear area  14  is surrounded by a soft, flexible flange member  15  which serves as the contact member between the patient&#39;s skin and the mask  10 , the flange member  15  and main body  11  being able to conform to the surface shape of the patient&#39;s neck due to the material of construction. With the mask in position on the patient&#39;s neck, the tracheostomy opening or tube is encircled by the flange member  15  and the main body  11  defines an enclosed space from which moistened air or other chosen gas or vapor material is drawn into the tracheostomy tube and through which exhaust air can be exhaled. The main body  11  has a bottom edge  16  and a top edge  17  comprising the lower and upper portions of the flange member  15 .  
      Extending from each side of the main body  11  are lateral wing members  12 , preferably composed of a soft, flexible material similar or identical to the material composing the main body  11 . The wing members  12  are generally triangularly shaped and a strap connecting means is provided in each wing member  12  for connecting a strap member  13 , such that the strap member  13 , preferably composed of an elastic band, foam, fabric or the like, can be positioned bout the patient&#39;s neck to temporarily secure the mask  10 . While the strap member  13  may be permanently affixed to the wing members  12 , preferably strap member  13  is removably attached such that its length can be adjusted and such that at least one, and preferably, both ends of the strap member  13  can be removed from the wing members  12 . As shown in the drawings, the strap connecting means may comprise a mechanical fastener  18  and a strap aperture  19 . With this structure, the strap member  13  can be drawn through the strap aperture  19  and tied or knotted once the proper length is achieved.  
      Connector member connecting means are provided such that a connector member  21  may be rotatably mounted onto the front of the main body  11 . The connector member connecting means as shown comprises in combination an annular internal flange member  41  disposed about a circular opening  40  in the front of the main body  11  and an annular channel member  42  disposed about a circular opening in the rear of the connector member  21  and adapted to receive the annular internal flange member  41 , but it is to be understood that other structures may be provided for the connector member connecting means. Connector member  21  is preferably composed of a plastic material more rigid than that of the main body, the material having sufficient rigidity such that little or no deformation occurs under finger pressure. Connector member  21  is preferably circular in configuration at its rear, such that the junction of the connector member  21  with the main body  11  defines a substantially vertical plane of rotation, the interconnection of the annular interior flange member  41  and the annular channel member  42  enabling the connector member  21  to be rotated relative to the main body  11 , preferably over a range of 360 degrees. The spherical forward portion of the connecting member  21  is provided with a circular opening  22  defined by tubular adaptor connecting means. Above the circular opening  22  are positioned a plurality of elongated, generally horizontally disposed exhaust openings  23 , preferably in the configuration of slits of decreasing length from the uppermost slit to the lowermost slit. The exhaust openings  23  provide means for the discharge of exhaled air, the elongated configuration being less likely to be obstructed or occluded, such as could occur with standard circular exhaust openings should an infant insert a finger into the circular opening.  
      A tubular adaptor member  31 , being the direct means for connecting a nebulizer tube or the like to the mask  10  and composed of a relatively rigid material similar or identical in physical properties to the material of composition of the connector member  21 , is rotatably mounted to the connector member  21  by tubular adaptor connecting means, which as shown comprises in combination an annular rim member  43  which defines the circular opening  22  and an annular channel member  44  that receives the annular rim member  43 . As before, it is to be understood that other structures may be provided for the tubular adaptor connecting means. The tubular adaptor member  31  comprises an elongated, preferably linear, tube portion  32 , and a relatively short, preferably linear, tube portion  34  connected together at an elbow or curved joint  33 , whereby the central axis of the elongated linear portion  32  is not parallel to the central axis of the short tube portion  34 . Preferably, the angle formed between the elongated tube portion  32  and the short tube portion  34  is approximately 45 degrees. The tubular adaptor member  31  is mounted to the connector member  21  such that the tubular adaptor member  31  may rotate relative to the connector member  21  about the central axis of the short tube portion  34 , preferably over a range of 360 degrees. The plane of rotation defined by the junction  54  of the tubular adaptor connector means is preferably at approximately 45 degrees to the plane of rotation defined by the junction  55  of the connector member connecting means, and therefore the plane of rotation defined by the tubular adaptor connector means is also approximately 45 degrees from vertical. In this manner the position of the tubular adaptor member  31 , by rotation of the connector member  21  and or rotation of the tubular adaptor member  31 , can be altered in infinite ways so as to provide the most comfortable and least obstructed path and position for the nebulizer tube. The tubular adaptor member  31  is provided with an annular lip member  35  on its free end to better secure the nebulizer tube.  
      To address the problems of known pediatric tracheostomy masks, it is imperative that the mask  10  be structured to better fit the confines of an infant or small child neck and chin area. To this end, the central portion of the top edge  17  of the main body  11  and the corresponding central portion of the flexible flange member  15  are provided with a forward extending recess  51 , such that a pronounced concave configuration is imparted in the top edge  17  when viewed from above, as shown best in  FIG. 3 . Additionally, a concave depression  52  is provided in the upper surface  53  of the main body  11 , the depression  52  extending forward from the recess  51 . The combination of the recess  51  and depression  52  account for the proximity of the chin of the infant patient to the mask  10 , given the relatively short neck length. This short neck length is also addressed by dimensioning the mask  10  such that the distance between the bottom edge  16  of the main body  11  and the lowermost point of the junction  54  between the tubular adaptor member  31  and the connector member  21 , with the connector member  21  rotated relative to the main body  11  such that the tubular adaptor member  31  is at its lowermost position, is approximately one quarter or more the overall height of the main body  11 . With this structure, the junction between the tubular adaptor member  31  and the connector member  21  is located at a higher position on the main body  11  than found on standard masks.  
      As a representative example, suitable approximate dimensions for the mask  11  consist of a height of 1.893 inches for the main body  11 , a tubular adaptor member  31  having an elongated tube portion of 1.13 inches and a diameter of 0.1875 inches, where lowermost point of the junction between the tubular connector  31  and the connector member  21  is 0.459 inches above the bottom edge  16  of the main body  11 .  
      Preferably, the mask  10  is provided with features that provide the impression of an animal character. As shown, the mask  10  can be adapted to give the appearance of an elephant head by configuring the lateral wing members  12  in the shape of elephant ears and providing markings that simulate eyes. The purpose of this adaptation is to present a less threatening image for the mask  10 , which can be soothing for both the patient and the patient&#39; parents and siblings.  
      It is understood that equivalents and substitutions for certain elements and components set forth above may be obvious to those skilled in the art, and therefore the true scope and definition of the invention is to be as set forth in the following claims.