Abstract:
A device ( 22 ) for analgesic immobilization in the event of thorax or rib fractures. The immobilization device ( 22 ) includes a flat splint element ( 24 ) which covers a large area of the region of the break ( 19 ), and is provided with an adhesive layer ( 26 ) which is located on the side thereof facing the body and which is used to adhere the immobilization device ( 22 ) to the body.

Description:
TECHNICAL FIELD  
       [0001]     The present invention relates to the field of medical aids. It comprises a device for analgesic immobilisation of fractured ribs (thorax immobilization device) according to the preamble part of claim  1 .  
         [0002]     Such a device is known from e.g. U.S. Pat. No. 4,312,334.  
       BACKGROUND ART  
       [0003]     Ribfractures are very painful, especially if more ribs are fractured simultaneously. The fractured ribs loose their mechanical stability, moreover, in specific cases, such as e.g. window-fractures, they are not capable any more of keeping the chest so thrown out that the lung inside could work undisturbed. This can be noticed especially at breathing when the patient experiences pain und this makes him/her to breath flatly (reduced forced vital capacity, FVC), or (in case of multiple fractures) forcing the patient to breath in a paradox way, in which the chest parts paricipating in breathing move in the opposite direction as usual. As in most of the rib fracture cases no intervention is performed, but natural healing occurs, it is desirable to administer some medicine for killing the pain of the patient in order to achieve better breathing.  
         [0004]     It has already been known for a long time that for immobilizing fractured ribs, the side with the fracture in the thorax can be fixed by an adhesive plaster, in order to reduce the movement of the fractured rib, however, this is usually not sufficient. There is a suggestion (GB-A-624,425) to use bundle-like, stretchable stripes instead of the plaster, which can be prestreched by means of a releasable stretching device. However, those immobilizing devices ensure a limited movability in the region of the fracture, but, at the same time, they hinder breathing to a large extent, as well.  
         [0005]     The earlier mentioned description U.S. Pat. No. 4,312,334 suggests to bind a frame around the patient the front side of the frame consisting of two vertical, arched supporting elements over the chest. The indented part of the thorax being in the fracture area is drawn out by means of a wire fixed on its one end to the chest and on the other end to the regarding supporting element. In this way, the fractured ribs can be kept in a position suitable for healing, easing the breathing resp. reducing pain.  
         [0006]     The draw-backs of this arrangement are partly the necessary intervention and the difficulty in positioning the wire, and partly the hindering of the patient in his/her movements by the streched wire and the frame.  
       SUMMARY OF THE INVENTION  
       [0007]     Based on the above, the task of the present invention is to create an analgesic immobilizing device for use in thorax fractures eliminating the draw-backs of the devices known, the device is simple to produce, easy to apply, quite safe to use and the application of the device results in a reduction of pain and improvement of breathing, without influencing significantly the free movement of the patient.  
         [0008]     The task is solved according to features described in claim  1 . The essence of the invention lies in a flat splint element covering the fracture area and possibly the fractured rib(s) and the neighbouring, not fractured ribs as well, which splint is provided with an adhesive layer on its side facing the body suitable for adhering the immobilizing device to the body. The splint element can be adhered to the fractured part of the thorax (fracture area) so that preferably the neighbouring, not fractured parts are also covered. The fractured ribs can be thus secured by the splint element being relatively rigid in itself, and at the same time, can be supported also by the uninjured ribs. This stabilization leads to reducing the pain and can facilitate breathing.  
         [0009]     In a preferred embodiment of the invention the splint element can be fitted to the outside contour of the thorax particularly without any additional aid or tool, whereas it preferably contains a deformable plastic plate or a plastically deformable metal plate. This plate increases further the efficiency of the splint and makes its application simpler.  
         [0010]     The plastically deformable metal plate is made preferably of aluminium, where the plastically deformable metal plate is corrugated in order to improve local deformability with increasing at the same time the rigidity, and the crests of corrugations of the plate are essentially parallel to the ribs to be treated. Such a splint material has already successful applications for different purposes (WO-A1-97/22312).  
         [0011]     The wear of such a splint element can be made more comfortable so that the upper and/or lower side of the splint element is provided with a covering, made preferably of some tissue, or of an elastic foam material particularly provided with open pores. In addition, some perforation can also be made in the splint element in order to achieve better permeability of the immobilizing device.  
         [0012]     In order to protect the immobilizing device against external effects, such as water or similar substances, it is preferable to use a protecting foil for covering the upper side of the splint element. This protecting foil can be adhered onto the splint element after applying the splint on the body. A protection of the sides can also be achieved in easy way so that the foil over the splint element sticks out on the sides, and forms a continuous rimstrip, whereas the lower side of the protecting foil is also provided with an adhesive layer in the field of the rimstrip.  
         [0013]     In order to reduce further the pain caused by rib fractures it is preferred if the immobilizing device is provided additionally also with some local analgesic substance. For this purpose, pain killers may be contained in pads or cushions coupled to the immobilizing device by a releasable bond. Another possibility is that parts of or the total of the adhesive layer contains a pain killer. 
     
    
     BRIEF DESCRIPTION OF THE FIGURES  
       [0014]     The invention will be explained on the basis of figures showing some embodiments.  
         [0015]      FIG. 1  illustrates a very simplified perspective view of a first embodiment of the immobilizing device of the invention for putting to rest position the injured ribs,  
         [0016]      FIG. 2  shows a top view of the immobilizing device shown in  FIG. 1 ,  
         [0017]      FIG. 3  is a top view from the front of an example of rib fracture showing four ribs from among which the second from the top is fractured,  
         [0018]      FIG. 4  shows the rib fracture in  FIG. 3  in a simplified section along the line IV-IV with the fracture area,  
         [0019]      FIG. 5  is a top view from the front of a second embodiment of the invention showing the immobilizing device adhered to the rib fracture shown in  FIG. 3 ,  
         [0020]      FIG. 6  illuestrates the effect of the adhered immobilizing device in a view similar to that in  FIG. 4 ,  
         [0021]      FIG. 7  shows an enlarged view of a section through the immobilizing device shown in  FIGS. 5 and 6 . 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0022]     The device according to the invention is applied to fractured (thorax fractures) or bruized ribs. In these cases the object is to prevent the movement of the injured ribs in the chest, or at least to reduce it to a great extent. It is especially of advantage that in case of a window-fracture (e.g. when more ribs being in a distance from each other are fractured forming thereby a window in the chest), the paradox breathing characteristic in these cases can be influenced in a positive way.  
         [0023]     An embodiment of such an immobilizing device and its application are shown in a significantly simplified way in  FIGS. 1 and 2 .  FIG. 1  shows the scheme of four ribs  15 - 18  from one side of a chest  13 , from among which the second rib from the top, rib  16  has a fracture  14 . The tissue and skin layers of the body over ribs  15 - 18  are not shown for simplicity reasons. The intercostal musculature is not shown either. A flat, splint-like immobilizing device  10  fitted to the arching of chest  13  is adhered to the area of chest  13  surrounding fracture  14 , on a large part of, or on the total surface. The main component of the immobilizing device  10  consists of a splint element  12  ( FIG. 2 ) in form of a plate made of a suitably rigid but plastically deformable material. Adhering is achieved by applying an appropriate adhesive layer  11  on the inside of splint element  12 , similarly to plasters ( FIG. 2 ). The size (lateral dimension) of the immobilizing device  10  is chosen preferably so that the immobilizing device  10  covers not only the injured rib  16 , but also the neighbouring ribs  15  and  17  in a sufficient manner.  
         [0024]     Through adhering, the immobilizing device  10  is supported by the not fractured part of the injured rib(s) and by the uninjured neighbouring ribs  15  and  17  and keeps the fractured rib  16  in a fixed position relative to the neighbouring ribs  15  and  17 . This hinders to a great extent any painful movement of the injured rib  16  at breathing, coughing, laughing or in other similar situations eliminating or at least reducing thereby the pain caused by these movements.  
         [0025]     Additionally, some means can also be applied locally to the inside of the immobilizing device  10  for reducing the pain caused by the injured rib  16 . Preferably pads or cushions impregnated with some analgesic material having its effect through the skin are used, which are connected to the inside of immobilizing device  10  by a releasable bond, e.g. by adhering or by hook and loop fastener. Another solution may be to impregnate parts of or the total adhesive layer  11  with a suitable pain killer.  
         [0026]     The effect of the immobilizing device  10  according to the present invention may be explained on the basis of  FIGS. 3-6 . In this case, we also have four parallel ribs  15 - 18 , from among which the second one from the top, rib  16  has a fracture  14  (of course, it is also possible that more fractured ribs are present). Considering the section of the chest along the line IV-IV in  FIG. 3 , the configuration shown in  FIG. 4  is obtained in a simplified form. Ribs  15 - 18  are embedded into intercostal musculatur  21  serving, among other things, for breathing. This is covered by a multilayer consisting of skin and fat tissues which, in a simplified way, can be denoted as a skin/fat tissue layer  20 . In the area of fracture (fracture area  19 ), the fractured rib  16  looses at least in part its stability, and as a result, a frictional movement (marked in  FIGS. 3 and 4  by duble arrows) of the ends of the fracture relatively to each other may occur causing significant pain to the patient at any movement of the chest.  
         [0027]     If, according to  FIGS. 5 and 6  a flat immobilizing device  22  is adhered to fracture area  19  involving rib  16  and preferably to the not injured ribs  15 ,  17  and  18  as well, fracture area  19  is stabilized so that rib  16  is immobilized in se and also relative to the other ribs  15 ,  17  and  18 . This leads to a less painful breathing of the patient improving thereby the way of his/her breathing, as well.  
         [0028]     Clinical experiments were carried out in 42 patients (33 of them using the immobilizing device, 9 being in the control group) which patients had fractures up to 5 neighbouring ribs, in which experiments the intensity of pain was determined by an analogous scale before the admission of the patients to the study, and 1-2, 24 and 48 hours after that. In comparing with the control group, the intensity of pain in rest (p&lt;0.05), and especially at forced inspiration (p&lt;0.01) was over the whole period significantly less than in the control patients. The reduction of pain owing to the use of immobilizing devices  10  or  22  was measurable already even 1 hour after putting them on, whereas the control patients experienced a measurable reduction of pain only after 2-3 days.  
         [0029]     Spirometric measurements were carried out in 18 patients before, and 1-2, 24 and 48 hours after the adhering of the immobilizing device (in several patients in all these periods). Two different sizes of immobilizing devices (12×17 cm and 15×18 cm) were used according to the size of the fracture area. In five further patients (control patients) was the fracture area covered only by operation pads. In these control patients the forced vital capacity (FVC) hindered by the fracture, was further reduced by 174 ml in the average after 1-2 hours, and improved within further 24 or 48 hours only by 4 or 34 ml. To the contrary, in patients treated with the immobilizing device, the FVC continuously and significantly improved (p&lt;0.001), by 153 ml in the average already after 1-2 hours, and by 384 and 474 ml after 24 and 48 hours, after the application of the immobilizing device. Just like FVC, the spirometric parameters FEV1, IVC and PEF improved also by using the immobilizing device.  
         [0030]     A preferred embodiment of immobilizing device  22  is shown in  FIGS. 5-7 . The immobilizing device  22  comprises a flat splint element  24  as central component, in the present case made of a corrugated aluminium plate. The thickness and corrugation of the plate are chosen so that splint element  24  may be fitted easily to the area of the fracture to be treated in the arching of the chest by bare hands without any additional aid, and on the other hand, it is appropriately rigid for its function as support and immobilizing means for the fracture. Splint elements described in WO-A1-97/22312 are also suitable for this purpose (this is why the dates about the material used in that description are taken over in the present application).  
         [0031]     In order to fit immobilizing device  22  best to the chest, the crests of the corrugations of splint element  24  are arranged parallel to the ribs. Splint element  24  is provided with a covering  25  on its lower side and covering  23  on its upper side for making its wearing more comfortable. Coverings  23  and  25  are preferably made of an elastic, foamed open-pored or perforated plastic material. Covering  25  at the lower side is provided with an adhesive layer  26  on its outer surface, by means of which the immobilizing device  22  can be adhered to the fracture area. As adhesive materials for the adhesive layer, every adhesive suitable for medical applications can be used. During application, the upper side of the immobilizing device  22 , e.g. the outer surface of covering  23  is adhered to a protecting foil  27  which is greater on the sides than the covering, thus forming a protruding rim  28  ( FIG. 5 ). If the protecting foil  27  with its protruding rim  28  is adhered to the skin of the patient, immobilizing device  22  is protected against external effects, thus the patient can e.g. take a shower without any negative consequence. The protecting foil is permeable for air (so called breathing foil) and water-tight. Splint elements  24  in the present invention may be made of other materials than corrugated aluminium plate, such as plastic plates or similar materials being rigid enough and at the same time, sufficiently plastically deformable. Splint element  24  is preferably provided with holes, e.g. in form of a perforation, in order to be permeable and being more comfortable to wear.  
       REFERENCE NUMBERS  
       [0000]    
       
           10 ,  22  immobilizing device  
           11  adhesive layer  
           12  splint element (flat)  
           13  chest  
           14  fracture  
           15 - 18  ribs  
           19  fracture area  
           20  skin/fat tissue layer  
           21  intercostal musculature  
           23  upper covering  
           24  splint element (flat)  
           25  lower covering  
           26  adhesive layer  
           27  protecting foil  
           28  rim (protecting foil)