Abstract:
A method and assembly for attaching a flexible longitudinal medical element to the face of a patient by providing a polymer strip having adhesive material on one side and hook material on the other. Also, a strip of loop material is affixed about the flexible longitudinal element. The loop material is engaged to and secured by the hook material, thereby affixing the flexible longitudinal element to the patient&#39;s face, at a desired location.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application is a continuation of application Ser. No. 10/667,728, filed Sep.22, 2003. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    An issue may arise when attaching a respiratory tube to a patient of finding a attachment location additional to the nose itself to attach the device so that the but stays correctly oriented relative to the nose. This problem is also encountered in the attachment, in general, of flexible longitudinal medical elements to a patient&#39;s face. 
       SUMMARY 
       [0003]    The present invention is a method and assembly for attaching a flexible longitudinal medical element to the face of a patient by providing a polymer strip having adhesive material on one side and hook material on the other. Also, a strip of loop material is affixed about the flexible longitudinal element. The loop material is engaged to and secured by the hook material, thereby affixing the flexible longitudinal element to the patient&#39;s face, at a desired location. 
         [0004]    The foregoing and other objectives, features and advantages of the invention will be more readily understood upon consideration of the following detailed description of the preferred embodiment(s), taken in conjunction with the accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS  
         [0005]      FIG. 1  is a top view of an infant nasal CPAP cannula seal according to the present invention. 
           [0006]      FIG. 2  is a cross-sectional view of the infant nasal CPAP cannula seal of  FIG. 1 , taken along line  2 - 2  of  FIG. 1 . 
           [0007]      FIG. 3A  is an illustration of opening an antiseptic container in a method of using a CPAP cannula seal according to the present invention. 
           [0008]      FIG. 3B  is an illustration of peeling a cannula seal from its releasable liner in a method of using a CPAP cannula seal according to the present invention. 
           [0009]      FIG. 3C  is an illustration of carrying a cannula seal to an infant&#39;s face in a method of using a CPAP cannula seal according to the present invention. 
           [0010]      FIG. 3D  is an illustration of placing a cannula seal on an infant&#39;s face in a method of using a CPAP cannula seal according to the present invention. 
           [0011]      FIG. 3E  is an illustration of placing a cannula seal over an infant&#39;s nose in a method of using the CPAP cannula seal according to the present invention. 
           [0012]      FIG. 4A  is an illustration of placing a strip of loop material about a cannula in a method of using a CPAP cannula seal according to the present invention. 
           [0013]      FIG. 4B  is an illustration of placing an additional loop material about a cannula in a method of using a CPAP cannula seal according to the present invention. 
           [0014]      FIG. 4C  is an illustration of a CPAP cannula seal having strips of loop material applied to, which represents a stage in a method of using a CPAP cannula seal according to the present invention. 
           [0015]      FIG. 5A  is an illustration of an alternative CPAP cannula seal assembly according to the present invention, in which the releasable liner assembly includes a first releasable liner, and a second releasable liner overlaps said first releasable liner. 
           [0016]      FIG. 5B  is an illustration of an alternative CPAP cannula seal assembly according to the present invention, in which the releasable liner assembly includes a releasable liner and a tab. 
           [0017]    FIG. SC is an illustration of an alternative CPAP cannula seal assembly according to the present invention, in which the releasable liner assembly includes a releasable liner that is cut into parts. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0018]    One embodiment of the present invention is a nasal CPAP seal  10  ( FIG. 1 ). Referring to  FIG. 2 , seal  10  is made principally of a  25  micrometer thick strip of flexible polyurethane  12  having a hydrocolloid  14  ( FIG. 2 ) laminated to it. Unlike CPAP seals that are cut out of wound dressing, seal  10  is semi-transparent. Wound dressing, because it is placed directly on an open wound, must be sterilized and because of its composition the only practical way of doing this is by bombarding it with gamma rays, which causes it to become opaque. Seal  10 , however, is not intended for use in treating open wounds, but rather to be placed on intact skin and mucous membrane. Although the manufacturing process is sanitary, there is no need to sterilize the seals  10 , allowing the production of a translucent, semi-transparent seal  10 , which permits inspection of the underlying skin and mucous membrane. As noted in the Background section this inspection is extremely important in the prevention of skin necrosis due to an imperfectly applied seal and in the prevention of nasal passageway closure, due to mucous build-up, which is a potentially life threatening condition. 
         [0019]    Seal  10 , which is between 10 mm and 15 mm long and between 3 mm and 10 mm wide, includes a pair of adherence wings  16 , for gently fixing the seal  10  onto the cheeks of an infant patient and a lip covering region  18  for adherence to the upper lip. Toward the center of seal  10 , a nose-covering region  20  defines a pair of apertures  22 , which are between 2 mm and 4.5 mm in major axis length and are spaced apart by from 1.5 mm to 3 mm, and are adapted to accommodate a pair of terminal air channels  24  ( FIGS. 4A-4C ) of the CPAP cannula  26  ( FIGS. 4A-4C ) . Although these apertures are shown as being round, an alternative preferred embodiment they are D-shaped. Significantly, a set of radially outwardly extending cuts or stellations  28  emanate from each aperture  22  ( FIG. 1 ). Not only do stellations  28  permit apertures  22  to accommodate any one of a few different cannula makes, as the cannula is inserted through aperture  22 , a set of tabs  30  defined by the stellations  28  are pushed inwardly so that they extend into the infant&#39;s nostrils, contacting and providing gentle support to the delicate intranasal mucous membrane. Only very small stellations  28  emanate from the septum side of the apertures  22 , to avoid weakening the thin strip of material between the apertures  22 . 
         [0020]    The nose-covering region  2 Q is defined, in part by a pair of cuts  32 , which facilitate region  20  in being folded upwardly relative to the lip adherence region  18  and wings  16 . Some embodiments do not include cuts  32 , as the wound dressing material is quite flexible and compressible. 
         [0021]    A v-shaped cleft  34  is defined by region  20  and helps region  20  fold in about the infant nose. In addition, a strip of hook material  50  is present on the lower part of lip covering region  18  and wings  16 . Material  50  is used to attach seal  10  to the cannula  26 , which is fitted with a pair of loop material strips  54  ( FIGS. 4A-4C ). 
         [0022]    In addition material  50  imparts structural rigidity to seal  10 , which is of value in the handling of seal  10 . 
         [0023]    A set of differently sized nasal CPAP seals of this make will be sold to accommodate various sizes of CPAP cannulas. It is anticipated that medical personnel will keep a range of seals on hand and pick an appropriate sized seal when needed. 
         [0024]    Referring to  FIGS. 3A-3E , a seal  10  is used by first removing it from a releasable liner  70  ( FIG. 3B ). It should be noted that liner  70  is not the same size and shape as seal  10 , as it would be if seal and liner were simultaneously cut from the same piece of wound dressing, as is the current practice. As liner  70  extends outwardly beyond the limits of seal  10 , it is easier for a user to first grasp liner  70  and then pry seal  10  free of it. In a neo-natal care unit setting where every second can make a difference to the health of the infant, this ease of use could well be a life saving feature in some instances. Next ( FIG. 3C ) seal  10  is supported in transport to the infant&#39;s face, so that adhering portions do not adhere to each other. Then, wings  16  are pressed into the infant patients cheeks ( FIG. 3D ). Finally nose-covering region  20  is folded upwardly to cover the infant nose, nostril apertures  22  are lined up with the nostrils ( FIG. 3E ) and region  20  is folded over the infant nose thereby closing cleft  34 . Finally, terminal air channels  24  are fitted into nostril apertures  22  and loop material  54  ( FIG. 4C ) is mated to hook material  50  to keep cannula  26  supported and in place. 
         [0025]    Referring to  FIG. 5A , in an alternative preferred embodiment, a release liner assembly  80  is made up of two a first release liner  82 , having a portion that is folded upwardly to provide a free area  86  and a second release liner  84 , which overlaps liner  82 , thereby providing a second free area  88  that a user may grasp in removing the second liner from the seal  10 .  FIG. 5B  shows yet another release liner assembly  90  in which a tab  92  is interposed between release liner  84  and seal  10 . In use tab  92  is grasped by a user and used to peel the release liner  84  away from seal  10 .  FIG. 5C  shows a still further release liner assembly  100  having a first release  102  and a second release liner  104 . When assembly  100  is bent and bowed outwardly, liners  102  and  104  partially separate from seal  10  to form a pair of free areas  1 Q 6 . 
         [0026]    The terms and expressions that have been employed in the foregoing specification are used as terms of description and not of limitation. There is no intention, in the use of such terms and expressions, of excluding equivalents of the features shown and described or portions thereof, it being recognized that the scope of the invention is defined and limited only by the claims which follow.