Abstract:
An improved non-invasive ear compression dressing or splinting device is provided for prevention, treatment and recurrence of injuries to the outer ear such as auricular hematoma. The device includes a structure including a pair of first and second pads, and a pressure applying assembly. The pads are assembled in pairs in opposing, facing relation to compressibly engage the injured portion of an external ear. The pressure applying assembly includes an adjustment mechanism for forcing one pad assembly towards the other in a continuously adjustable, controlled manner creating a compression of the ear tissues required for proper healing between the two opposing pads.

Description:
[0001]    This application is a continuation of U.S. patent application Ser. No. 11/544,721 filed on Oct. 10, 2006. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    Devices and surgical procedures to aid in the prevention and healing of injuries to the external ear are rudimentary, crude, and painful. The most common such injury is auricular hematoma typically inflicted during contact sports such as wrestling, boxing, or rugby which if left untreated, or improperly treated, results in the hematomas becoming fibrotic and disfiguring, a thickening of the tissue known as “cauliflower ear”. Many protective devices such as U.S. Pat. Nos. 5,504,945 and 5,615,417 are intended to protect the tissues of the ear although history indicates devices such as these to either be too cumbersome to use consistently, minimally effective, or too inconvenient. 
         [0003]    In addition to use in the treatment of auricular hematomas, pressure dressings are also used in many other treatments of the ear, such as the covering and compressing of an acute wound to the ear, the excision of a skin cancer, the placement of a skin graft, the repair of a torn earlobe, the treatment of a localized burn, or the excision of a keloid which can form on the earlobe or other portions of the ear after piercing thereof. Similar injuries and treatments occur with ears of animals. 
         [0004]    Auricular hematomas are caused by a blunt trauma or shearing force to the external ear that disrupts the adherence of the perichondrium or skin of the ear to the underlying cartilage and the subsequent filling of the subperichondrial space with blood. Application of pressure when discomfort and preliminary trauma is incurred helps to prevent more serious damage. Once more serious damage has occurred, standard treatment involves needle aspiration of the hematoma or, better, incision and drainage, followed by compression of the injured area to prevent re-accumulation of fluid and to allow re-apposition of the perichondrium to the underlying cartilage; the application of pressure is crucial. Avoiding infection is another important measure to prevent further complications. 
         [0005]    Several different compression techniques using pressure dressings have been employed to keep the skin in the necessary close contact with the cartilage during healing. The pressure dressings generally fall into the categories of suture compression dressings, mastoid dressings (i.e. dressings attached to the head by adhesive tape or other such methods), and molds (e.g. silicone) which are used with or without suturing or mastoid dressings. 
         [0006]    Mastoid dressings are generally disfavored because of their bulkiness and tendency to come loose or be dislodged. Molds generally tend to be expensive and time consuming to apply. Since molds are very closely conforming, they do, however, tend to apply a more uniform pressure with force vectors that are directed orthogonally to a greater area of the structure involved in the injury. However, as the injured area becomes more or less inflamed either with the progression of healing and reduction of inflammation or by increased trauma and increase in inflammation, molds are unable to compensate for the adjustment in force required to maintain constant pressure. 
         [0007]    Suture dressings, while invasive, are less bulky and more often effective. The most common method of applying pressure to the effected area involves suturing pressure dressing materials (often cotton balls or dental rolls with an antibiotic/antiseptic applied) positioned on opposing sides of the injured portion of the ear. The sutures are passed through the cartilage of the ear to gently squeeze the skin and cartilage together between the dressings. This method often does not provide evenly distributed pressure over the injured area and as a result, blood can re-accumulate under the skin to reform the hematoma. Reformation of the hematoma requires repeated aspiration of the accumulated blood. In order to provide a more evenly distributed pressure over the entire area of the injury, multiple sutures are necessary. Not only do these sutures through the ear cause much pain, but the risk of infection increases; with each aspiration or re-incision, infection potential is greater. 
         [0008]    U.S. Pat. No. 5,827,212 attempts to more evenly distribute the pressure over the injured area although it still involves painful sutures through the ear tissue, introduces an increased risk of infection, and does not allow for adjustment of the applying force once installed. 
         [0009]    U.S. Pat. No. 5,295,950 provides a non-invasive resolution of providing pressure to the outer ear utilizing a ductile metal strip with cushioning pads, eliminating the pain and risk of infection associated with penetrating the ear tissue with sutures. However, the force and resulting pressure applied to the ear is fixed by the physical nature of the ductile metal and amount of pressure applied when installed. No adjustability which is critical over time is included in this design other than removing and reapplying the device. Since the healing process takes several weeks for the skin to reattach, the dressing must be left in position for extended periods. As the healing process continues and the fluid increases or decreases, this method is unable to adjust for the change in thickness of the ear and pressure within the subperichondrial space. Loose dressings become less effective in maintaining sufficient pressure for complete heating and thickening and permanent deformity of the tissue can result. 
         [0010]    A concept used for applying pressure on various other jointed body parts as in ankle, knee, neck or back splints and supports is a pneumatic concept and is utilized in U.S. Pat. Nos. 5,125,400, 5,316,547, 5,348,530, 5,407,421, 5,520,622, 5,542,911, and 5,623,723 although not specifically for ears 
         [0011]    The present inventors recognize it would be advantageous to provide a non-invasive device which provides a constant, evenly applied pressure over the effected area of the injured ear, by being able to be easily adjusted upon initial application and over the course of the healing process of several weeks. 
         [0012]    The present inventors recognize it would be advantageous to provide a device which reduces the pain associated with treatments currently used. 
         [0013]    The present inventors recognize it would be advantageous to minimize the risk of infection associated with treatments commonly in use. 
         [0014]    The present inventors recognize it would be advantageous to provide a reusable device. 
         [0015]    The present inventors recognize it would be advantageous to provide a device that can adjust continuously within an operative range the pressure applied. 
       SUMMARY OF THE INVENTION 
       [0016]    The invention provides a non-invasive compression type device for aiding in the prevention, treatment and healing of injuries of the external ear (pinna). The device provides n continuously adjustable within an operative range and re-useable mechanism for continuously applying even pressure directly to the outer ear often needed in the treatment of auricular hematoma. 
         [0017]    The device comprises a structure which extends over the cartilaginous rim portions of the ear or structures on either side of the external ear that allows application of pressure to the effected area is employed which incorporates pads or cushions. Application of pressure is accomplished by adjustably moving one of the pads closer towards the other creating a progressively smaller space between the pads within which the skin and tissue of the ear are caused to compress and re-adhere or remain intact; any fluids within the spaces of the perichondrium are forced out and cannot re-enter. 
         [0018]    The device comprises an adjustment mechanism for creating the force for applying pressure. The adjustment device may be implemented in various embodiments and include mechanisms such as a screw, eccentric cam, inclined plane, fluidic, electromagnetic, and magnetic. These mechanisms can provide continuous adjustability within an operative range, allows re-use of the device if removed from the ear for any reason, and manually compensates for increases or reductions in pressure of the subperichondrial space in the effected area from increasing inflammation or decreasing amounts of fluid due to healing or other factors. 
         [0019]    Numerous other advantages and features of the present invention will be become readily apparent from the following detailed description of the invention and the embodiments thereof, from the claims and from the accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0020]      FIG. 1  is a side view showing an embodiment of the invention positioned on an ear; 
           [0021]      FIG. 2  is a rear view taken from  FIG. 1  with a screw thread pressure applying mechanism; 
           [0022]      FIG. 3  is a rear view taken from  FIG. 1 , with a pressure applying mechanism located on the opposite (inside, close to the head) side of the ear as that shown in  FIG. 2 ; 
           [0023]      FIG. 4  is a section view of the embodiment shown in  FIG. 2  taken along line  4 - 4  of  FIG. 1 ; 
           [0024]      FIG. 5  is a section view similar to  FIG. 4  of an alternative embodiment having a screw thread pressure applying mechanism; 
           [0025]      FIG. 6  is a section view similar to  FIG. 4  of an alternative embodiment having a screw thread pressure applying mechanism; 
           [0026]      FIG. 7  is a section view similar to  FIG. 4  of an alternative embodiment having a screw thread pressure applying mechanism; 
           [0027]      FIG. 8  is a section view similar to  FIG. 4  of an alternative embodiment having an eccentric cam pressure applying mechanism; 
           [0028]      FIG. 9  is a section view similar to  FIG. 4  of an alternative embodiment having an inclined plane pressure applying mechanism; 
           [0029]      FIG. 10  is a section view similar to  FIG. 4  of an alternative embodiment having a fluidic (pneumatic) pressure applying mechanism; 
           [0030]      FIG. 11  is a section view similar to  FIG. 4  of an alternative embodiment having an electro-magnetic solenoid pressure applying mechanism; 
           [0031]      FIG. 12  is a section view similar to  FIG. 4  of an alternative embodiment having a magnetic pressure applying mechanism. 
       
    
    
     DETAILED DESCRIPTION 
       [0032]    While this invention is susceptible of embodiments in many different forms, there are shown in the drawings, and will be described herein in detail, specific embodiments thereof with the understanding that the present disclosure is to be considered as an exemplification of the principles of the invention and is not intended to limit the invention to the specific embodiments illustrated. 
         [0033]      FIG. 1  shows a side view of the pinna  15  or outer ear with a structure  16  of one embodiment of the invention utilizing one example of a screw thread pressure applying mechanism. Pad  17  is shown on the outside surface of the pinna  15  in relative position depending on specific location of the hematoma and to assure adequate compression of the underlying tissues of the perichondrium. 
         [0034]      FIG. 2  is a rear view of  FIG. 1  with the screw thread pressure applying device located on the outer (away from the head) side of the pinna  15 . As the screw thread  19  is adjusted so as to reduce the space between pads  17  and  18 , the underlying tissues of the perichondrium are compressed between said pads. In an embodiment, the pads  17 ,  18  comprise gelatinous fluid or other materials conformable to the contours of the pinna when engaged with the pinna. The gelatinous fluid or said other materials may be resilient to return the pad to its initial, nonconformed, condition when not engaged with the ear. 
         [0035]      FIG. 3  is a rear view of  FIG. 1  with the screw thread pressure applying mechanism located on the inner (close to the head) side of the pinna  15 . As the screw thread  19  is adjusted so as to reduce the space between pads  17  and  18 , the underlying tissues of the perichondrium are compressed between said pads. The operation of the pressure applying device is acting in the same manner as in  FIG. 2  only from this alternate position. 
         [0036]      FIG. 4  is a section view of the screw thread pressure applying device of  FIG. 2  showing the attachment detail of the threaded screw  19  to the actuating pad  17  holder  20 . The rotational movement of the threaded screw  19  is free with respect to the pad  17  holder  20  as the end of the threaded screw  19  is captured loosely within a cavity  21  in pad  17  holder  20  such that the pad  17  holder  20  is pushed or pulled as moves the threaded screw  19 , thus allowing the pad  17  to maintain its fixed position on the pinna  15  while the inward or outward movement of the threaded screw relative to the structure  16  creates the force which is transmitted directly to the pad  17 . This force creates an evenly applied pressure across the face of said pad  17  to the underlying tissues of the perichondrium and is equally resisted on the opposite side of the pinna  15  by the pad  18 . 
         [0037]      FIG. 5  is a section view similar to  FIG. 4  of an alternative embodiment having a structure  38  utilizing a second example of a threaded screw pressure applying device. As the rotational movement of the threaded screw  21  moves vertically downward, contact is made with the connecting arm  22  hinged at  23 . The force is transmitted through this connecting arm  22  to the actuating pad  17  holder  24  via the pivoting joint  25  whereby the pad  17  is free to maintain its fixed position against the pinna  15 . This creates an evenly applied pressure across the face of said pad  17  to the underlying tissues of the perichondrium which is equally resisted on the opposite side of the pinna  15  by the pad  18  via the structure  38 . As noted in  FIG. 3 , the pressure applying device may also be located on the inner side of the pinna  15 . 
         [0038]      FIG. 6  is a section view similar to  FIG. 4  of an alternative embodiment having a structure  38  utilizing a third example of a threaded screw pressure applying device. As the rotational movement of the threaded screw  26  moves vertically downward, contact is made with the angled pad  17  holder  27  hinged at  28  with a connecting swing arm  47  hinged at  25 . The force is transmitted through this angled pad  17  holder  27  to the actuating pad  17  such that the pad  17  is free to maintain its fixed position against the pinna  15  while the movement creates an evenly applied pressure across the face of said pad  17  to the underlying tissues of the perichondrium and is equally resisted on the opposite side of the pinna  15  by the pad  18  via the structure  38 . As noted in  FIG. 3 , the pressure applying device may also be located on the inner side of the pinna  15 . 
         [0039]      FIG. 7  is a section view similar to  FIG. 4  of an alternative embodiment having a fourth example of a threaded screw pressure applying device. The rotational movement of the threaded screw  29  is free with respect to the pad  17  holder  30  as the end of the threaded screw  29  is captured loosely within a cavity  31  in pad  17  holder  30  such that the pad  17  holder  30  is pushed or pulled as moves the threaded screw  29  in corresponding threads in pad  18  holder  32  thus allowing the pad  18  to maintain its fixed position on the pinna  15  while the inward or outward movement of the threaded screw  29  relative to pad  18  holder  32  creates the force which is transmitted directly to the pad  18 . This force creates an evenly applied pressure across the face of said pad  18  to the underlying tissues of the perichondrium and is equally resisted on the opposite side of the pinna  15  by the pad  17 . As noted in  FIG. 3 , the pressure applying device may also be located on the inner side of the pinna  15 . 
         [0040]      FIG. 8  is a section view similar to  FIG. 4  of an alternative embodiment having a structure  39  utilizing an eccentric cam lever  33  as the pressure applying device. As eccentric cam lever  33  rotates about pivot point  34 , the increasing or decreasing radius at the point of contact with pad  17  holder  35  causes pad  17  holder  35  and pad  17  to move inward or outward relative to pinna  15 . The force is transmitted through this pad  17  holder  35  to the pad  17  such that the pad  17  is free to maintain its fixed position against the pinna  15  while the movement creates an evenly applied pressure across the face of said pad  17  to the underlying tissues of the perichondrium and is equally resisted on the opposite side of the pinna  15  by the pad  18  via the structure  39 . As noted in  FIG. 3 , the pressure applying device may also be located on the inner side of the pinna  15 . 
         [0041]      FIG. 9  is a section view similar to  FIG. 4  of an alternative embodiment having a structure  40  utilizing an inclined plane  36  as the pressure applying device. As the inclined plane  36  is pushed vertically downward within slot  38  in structure  40  contact is made with the pad  17  holder  37  causing pad  17  holder  37  and pad  17  to move inward or outward relative to pinna  15 . The force is transmitted through pad  17  holder  37  to the pad  17  such that pad  17  and pad  17  holder  37  is free to maintain its fixed position against the pinna  15  while the movement creates an evenly app lied pressure across the face of said pad  17  to the underlying tissues of the perichondrium and is equally resisted on the opposite side of the pinna  15  by the pad  18  via the structure  40 . As noted in  FIG. 3 , the pressure applying device may also be located on the inner side of the pinna  15 . 
         [0042]      FIG. 10  is a section view similar to  FIG. 4  of an alternative embodiment having a structure  41  incorporating a fluidic pressure applying device. In this view, a pneumatic bladder  42  fills with air and expands thus causing pad  17  attached to pneumatic bladder  42  to move inward or outward relative to pinna  15 . The force is transmitted through pad  17  such that the movement creates an evenly applied pressure across the face of said pad  17  to the underlying tissues of the perichondrium and is equally resisted on the opposite side of the pinna  15  by the pad  18  via the structure  41 . As noted in  FIG. 3 , the pressure applying device may also be located on the inner side of the pinna  15 . 
         [0043]    Pressure is created by pressing on the flexible bulb  43  with the pressing member, usually a person&#39;s finger, covering the hole  45  with which air initially fills the space within the bulb. This pressing action and resulting collapse of the bulb causes the entrapped air to be pushed into the internal cavities of structure  41  through a pressure retention normally closed check valve  44  and into the pneumatic bladder  42 . Pressure can be manually released from the internal cavities of structure  41  and pneumatic bladder  42  by pressing pressure retention normally closed valve  46 . 
         [0044]      FIG. 11  is a section view similar to  FIG. 4  of an alternative embodiment having a structure  50  incorporating an electromagnetic solenoid pressure applying device. In this view, an electric solenoid coil  51  surrounds solenoid plunger  52  which is integrally attached to pad  17  holder  53 . Electrically connected to one end of the electric solenoid coil  51  wire is an electrical circuit including a variable resistance capability, electricity flow direction control, and on/off switching capability  55  which connects to the positive side of disk battery  54 . The other wire of the electric solenoid coil  51  is connected electrically to the negative side of disk battery  54 . As electricity is applied to electric solenoid coil  51  from disk battery  54  the electromagnetic field created causes the solenoid plunger  52  to move inward or outward relative to, pinna  15 . The movement is transmitted through pad  17  such that the force creates an evenly applied pressure across the face of said pad  17  to the underlying tissues of the perichondrium and is equally resisted on the opposite side of the pinna  15  by the pad  18  via the structure  50 . As noted in  FIG. 3 , the pressure applying device may also be located on the inner side of the pinna  15 . 
         [0045]      FIG. 12  is a section view similar to  FIG. 4  of an alternative embodiment having a magnetic pressure applying device. In this view, an electric coil  60  surrounds permanent magnet  61  which is integrally attached to pad  17 . Pad  18  is integrally attached to permanent magnet  62 . Each permanent magnet  61  and  62  have north-south poles as indicated, and are oriented such that the opposing poles attract each other. The magnetic forces thus created cause an evenly applied pressure across the face of pad  17  to the underlying tissues of the perichondrium and is equally resisted on the opposite side of the pinna  15  by the pad  18 . 
         [0046]    Electrically connected to one end of the electric coil  61  wire is an electrical circuit including a variable resistance capability, electricity flow direction control, and on/off switching capability  64  which connects to the positive side of disk battery  63 . The other wire of the electric coil  61  is connected electrically to the negative side of disk battery  63 . As electricity is applied to electric coil  61  from disk battery  63  the electromagnetic field, created causes the strength of permanent magnet to be reduced or increased depending on flow of electricity direction thereby allowing this electrical circuitry to provide adjustability of the magnetic attraction and resulting pressure transmitted across the face of pad  17  to the underlying tissues of the perichondrium which is equally resisted on the opposite side of the pinna  15  by the pad  18 . As noted in  FIG. 3 , the pressure applying device may also be located on the inner side of the pinna  15 . 
         [0047]    From the foregoing, it will be observed that numerous variations and modifications may be effected without departing from the spirit and scope of the invention. In actual production designs, provisions for user friendliness, for economic manufacturing practices and techniques, and for maximizing effectiveness would be included and provided for which have not been identified as part of this patent but which would still render the device as being completely covered under the intent of this patent. The embodiment previously described is illustrative of the principles of this invention. It should be understood, modifications can be made without departing from the scope of the invention. It is to be understood that no limitation with respect to the specific apparatus illustrated herein is intended or should be inferred. It is intended to cover by the appended claims all such modifications as fall within the scope of the claims.