Abstract:
A mechanical load bearing indicator producing signals to a user when the user applies more than selected amounts of load between an extremity of the use and a surface. The indicator has a base plate adapted to establish a frame of reference with the surface, a load plate mounted for movement toward and away from the base plate and adapted to receive loads from the user&#39;s extremity, and at least two snap domes mechanically engaged between the base plate and the load plate for generating two signals when more than two different respective loads are applied to the load plate by the extremity. The domes are either in series between the plates or are together in a dual dome containing both, or are one or more stacks of domes which individually collapse under incremental loads which are added together to form the selected lower and higher loads.

Description:
FIELD AND BACKGROUND OF THE INVENTION 
       [0001]    The present invention relates, in general, to force indicators for medical or biological uses, and in particular, to a new and useful weight bearing indicator which is purely mechanical yet provides an unambiguous message, both tactile and audible, to a person wearing the indicator when two different amounts of force between the person&#39;s foot and the ground have been exceeded. 
         [0002]    Following orthopedic surgery or injury to the lower extremities, patients are encouraged to gradually bear weight on their limb, but are warned not to exert more than a certain limited amount of force on the injured extremity. 
         [0003]    As a result, most patients do not apply any weight or apply insufficient weight to the injured lower extremity in fear of causing further damage or pain. The application of weight is necessary, however, for proper recovery and not applying any weight is almost as detrimental as applying too much weight. A survey was conducted at Albany Medical College (Albany, N.Y.) involving over 100 patients. The patients indicated that often no weight was applied to the injured foot. Furthermore, a pilot clinical study was conducted on twenty bunionectomy patients who were given surgical sandals equipped with weight bearing indicator based on U.S. Pat. No. 6,405,606 (which will be discussed in greater detail later in this disclosure) and told to partial weight bear for a period of six weeks. Over two thirds of the patients that responded indicated that the device was useful for their recovery. Also see Walczyk, D. F., Bartlet, J. P., “An Inexpensive Weight Bearing Indicator Used for Rehabilitation of Patients with Lower Extremity Injuries,”  Journal of Medical Devices,  2006. 
         [0004]    Electronic devices are known which sense the force applied to a foot and provide a signal to the wearer. See, for example, U.S. Pat. No. 5,408,873 which discloses a foot force sensor and U.S. Pat. No. 5,357,696 which discloses a device for measuring force applied to a wearer&#39;s foot. 
         [0005]    Additional relevant patents, are listed by patent number and title as follows: 
         [0000]    
       
         
               
               
             
           
               
                   
               
               
                 Patent 
                   
               
               
                 Number 
                 Title of Invention 
               
               
                   
               
             
             
               
                 6,122,846 
                 Force Monitoring Shoe 
               
               
                 6,031,463 
                 Load Signaling Device for a Patient&#39;s Foot 
               
               
                 5,619,186 
                 Foot Weight Alarm 
               
               
                 5,323,650 
                 System for Continuously Measuring Forces Applied to the 
               
               
                   
                 Foot 
               
               
                 5,269,081 
                 Force Monitoring Shoe 
               
               
                 5,253,654 
                 Orthopedic Weight Monitor 
               
               
                 4,858,620 
                 Warning System for Excessive Orthopedic Pressures 
               
               
                 4,814,661 
                 Systems for Measurement and Analysis of Forces Exerted 
               
               
                   
                 During Human Locomotion 
               
               
                 4,745,930 
                 Force Sensing Insole for Electro-Goniometer 
               
               
                 4,647,918 
                 Multi-event Notification System for Monitoring Critical 
               
               
                   
                 Pressure Points on Persons with Diminished Sensation of the 
               
               
                   
                 Foot 
               
               
                 3,974,491 
                 Load Signaling Device for a Patient&#39;s Foot 
               
               
                 3,791,375 
                 Device for Sensing and Warning of Excessive Ambulation 
               
               
                   
                 Force 
               
               
                 3,702,999 
                 Partial Weight Bear Warning Device. 
               
               
                   
               
             
          
         
       
     
         [0006]    An electronic weight bearing alarm contained within a surgical shoe is also available under the trademark PEDALERT from Planet, LLC (Madison, Wis.). This device monitors the amount of weight a patient places on his or her lower limb through an advanced membrane sensor. An audible beep warning is generated when the weight limit is exceeded. A similar electronic device that can be placed in a patient&#39;s shoe is available under the trademark SANOSTEPPER from Sanostep, GmbH or Tauting, Germany. 
         [0007]    Two patents of particular relevance since they use simple mechanical snap members to signal the wearer of the device and require no power and no complex mechanism, are U.S. Pat. No. 6,405,606, issued to one of the co-inventors of the present application (Walczyk) and another inventor in 2002 for Mechanical Weight Bearing Indicator for the Foot, and U.S. Pat. No. 6,752,028, issued in 2004 for Load Monitoring Test Device for a Patient&#39;s Foot. U.S. Pat. No. 6,405,606 is incorporated here by reference. 
         [0008]    Neither of these patents disclose or suggest how, without power or complex mechanisms, two separate signals can be issued to the person wearing the device, which correspond to two different loads. 
         [0009]    The need remains for a simple mechanical device which produces unmistakable feedback signals for a patient when two different loads are being applied to the patient&#39;s foot, so that the patient can be taught to exert a minimum desirable load on the foot during each step, but to avoid exerting more than a maximum desirable load. 
       SUMMARY OF THE INVENTION 
       [0010]    An object of the present invention is to provide a simple mechanical device which produces at least two separate tactile and audible feedback signals for a person or patient who wears the device in his or her shoe, sandal, boot, or other medical appliance for the foot (collectively referred to here as footwear), corresponding to two different loads applied to the persons foot during each step. 
         [0011]    The device of the present invention resets automatically when the load is removed and requires no power source. Accordingly, there are no batteries to run down and no recharging required to maintain the usefulness of the invention for long periods of time. 
         [0012]    A patient recovering from lower extremity injuries, surgery or other conditions such as orthopedic patients, neurological patients (e.g., stroke victims), athletes and the like, simply inserts the device of the present invention into his or her footwear, or wears footwear containing the device of the present invention, and walks in a normal fashion or as prescribed by a medical professional. The present invention can also be incorporated into an orthotic device or cast worn by the patient on their foot. Any such foot covering structure is also considered to be footwear for the purpose of this disclosure. 
         [0013]    The invention is a purely mechanical device which reacts to a first amount of weight or load being applied through it, that is, between the bottom of the patient&#39;s foot and the ground, and indicates to the patient when a first level of load has been achieved. The patient is encouraged to step firmly enough to generate this first signal for faster healing of the injury, and since this amount of load has been authorized by the patient&#39;s medical professional, the patient is less afraid of further injury by taking such a firm step. 
         [0014]    To avoid further injury, however, a second signal is generated if the person applies more that a maximum desired load to the foot during each step. This second signal, also generated without external electrical power and automatically reset after each step, corresponds to a pre-selected value, e.g., the maximum weight permitted at the particular stage of the patient&#39;s recovery. 
         [0015]    All embodiments of the invention are reusable and automatically reset. In this way, the patient is provided with ongoing feedback on the amount of force he or she may apply to the injured area. 
         [0016]    According to the invention, the device can be configured to provide indications at different minimum and maximum loads so that the patient can be permitted to exert higher force as the healing process continues. 
         [0017]    Since the device is purely mechanical, there is no threat of electrical shock to the patient. Furthermore, a mechanical design is inherently more robust and inexpensive to manufacture, as compared to an electronic device such as the PEDALERT device. 
         [0018]    Another advantage of the invention is that the feedback signal, including the audible sound, is perceptible, generally only by the patient so that less attention is drawn to the patient or the patient&#39;s condition as compared to other devices. 
         [0019]    In addition to its therapeutic value, the present invention is also a simple device for use in athletics, physical therapy, gait analysis and the like, wherever a set force limit is desirable or not desirable for applying between a part of the body and another surface. 
         [0020]    Accordingly an object of the present invention is to provide a purely mechanical load bearing indicator for producing signals to a user when the user applies more than selected amounts of load between an extremity being used and a surface, comprising a base plate adapted to establish a frame of reference with the surface, a load plate mounted for movement toward and away from the base plate and adapted to receive loads from the user&#39;s extremity, and at least two snap domes mechanically engaged between the base plate and the load plate for generating two signals when more than two different respective loads are applied to the load plate by the extremity. 
         [0021]    Another object of the invention is to provide the domes in series or as a dual dome containing both, as one or more stacks of domes which individually collapse under incremental loads which are added together to form the selected lower and higher loads. Another object of the present invention is to provide a mechanical weight bearing indicator which is simple in design, rugged in construction and economical to manufacture. 
         [0022]    The various features of novelty which characterize the invention are pointed out with particularity in the claims annexed to and forming a part of this disclosure. For a better understanding of the invention, its operating advantages and specific objects attained by its uses, reference is made to the accompanying drawings and descriptive matter in which preferred embodiments of the invention are illustrated. 
     
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0023]      FIG. 1  is a side elevational view that is partly in section of a first embodiment of the mechanical weight bearing indicator of the present invention; 
           [0024]      FIG. 2  is a top plan view of a snap dome that can be used in many of the embodiments on the invention, including the embodiment of  FIG. 1 ; 
           [0025]      FIG. 3  is a perspective view of the embodiment of  FIG. 1  with an upper load transfer partly transparent to reveal the snap dome structure; 
           [0026]      FIG. 4  is a view similar to that of  FIG. 1 , but of a second embodiment of the invention; 
           [0027]      FIG. 5  is a view similar to  FIG. 3  but of the second embodiment; 
           [0028]      FIG. 6  is a view similar to  FIG. 5  but with additional features according to a third embodiment of the invention; 
           [0029]      FIG. 7  is a perspective view of footwear it a portion cut away to reveal the mechanical weight bearing indicator of  FIG. 6  in combination with the footwear; 
           [0030]      FIG. 8  is a side elevational view, partly in section of a fourth embodiment of the invention; 
           [0031]      FIG. 9  is a perspective view thereof; 
           [0032]      FIG. 10  is a view similar to  FIG. 8  but of a fifth embodiment of the invention; 
           [0033]      FIG. 11  is a view similar to  FIG. 9  but of the fifth embodiment; 
           [0034]      FIG. 12  is a schematic side view of a sixth embodiment of the invention; 
           [0035]      FIG. 13  is a schematic side view of a seventh embodiment of the invention; 
           [0036]      FIG. 14  is a schematic side view of an eighth embodiment of the invention; 
           [0037]      FIG. 15  is a schematic side view of a ninth embodiment of the invention; 
           [0038]      FIG. 16  is a schematic side view of a tenth embodiment of the invention; 
           [0039]      FIG. 17  is a schematic side view of an eleventh embodiment of the invention; 
           [0040]      FIG. 18  is a schematic side view of a twelfth embodiment of the invention; 
           [0041]      FIG. 19  is a schematic side view of a thirteenth embodiment of the invention; 
           [0042]      FIG. 20  is a schematic side view of a fourteenth embodiment of the invention; 
           [0043]      FIG. 21  is a schematic side view of a fifteenth embodiment of the invention; 
           [0044]      FIG. 22  is a schematic side view of a sixteenth embodiment of the invention; 
           [0045]      FIG. 23  is a schematic side view of a seventeenth embodiment of the invention; 
           [0046]      FIG. 24  is a schematic side view of an eighteenth embodiment of the invention; 
           [0047]      FIG. 25  is a schematic side view of a nineteenth embodiment of the invention; 
           [0048]      FIG. 26  is a schematic side view of a twentieth embodiment of the invention; and 
           [0049]      FIG. 27  is a schematic side view of a twenty-first embodiment of the invention. 
       
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0050]    Referring to the drawings in particular, the invention embodied in  FIGS. 1 ,  2  and  3  comprises a purely mechanical weight bearing indicator generally designated  10 , having a load transfer plate and base plate that sandwiches two snap domes  16  and  18  of different buckling loads in a back-to-back arrangement, that is with the large diameter bases of the domes, facing away from each other. One snap dome buckles at the lower load of a limb load range prescribed by a medical professional (e.g., an orthopedist), for example 40 lbs., while the other snap dome buckles at the higher or maximum load, e.g. 100 lbs. In this arrangement, the lower load dome  18  will buckle first when the total load through the stack exceeds 40 lbs., followed by the large dome  16  buckling when the total load exceeds 100 lbs. In normal operation, the patient will hear and feel a high-pitched click from the lower load dome buckling every time they exceed 40 lbs. For correct rehabilitation, the patient should hear and feel this every time they step on the injured limb. However, they will hear and feel a louder click from the upper load dome buckling every time they exceed 100 lbs. This indicates that the patient has put too much load on the limb. 
         [0051]    The choice of snap dome(s) buckling load for the upper and lower load limits is critical to the operation of this invention. In general, the upper load snap dome(s) must buckle at a load greater than the lower load snap dome(s). For example, if the lower load is 20 lbs, then a single or stack of domes would be chosen appropriately to buckle at this load. Then, the upper single or stack of domes for the upper load must be chosen so as to buckle at a load greater than 20 lbs; say 30 lbs for this example. The load limb range would approximately be 20 lbs (i.e. lower load dome(s) buckling) to 50 lbs (i.e. lower load dome(s) compressed at 20 lbs+30 lbs from upper load dome(s) buckling). In essence, the upper and lower load domes behave similarly to two springs in a series arrangement. If the upper load dome(s) were chosen to buckle at less than 20 lbs, say 15 lbs for this same example, then 15 lbs would actually serve as the lower load limit. 
         [0052]      FIG. 2  is a non-limiting example of a metal snap dome that is commercially available in a wide variety of sizes and load specifications. If has four curved lobes  20  formed as one piece with a central concave area  22  having a hole  24  through its center. 
         [0053]    Such snap domes are available, for example from, Snaptron Inc. of 960 Diamond Valley Drive, Windsor, Colo. 80550. While these domes are used primarily in switches, the person of ordinary skill in the art of the present invention can utilize their service to provide snap domes for use with the present invention. Snaptron Inc. maintains a website at URL: http://www.snaptron.com/f_series.cfm. A wide variety of snap domes in various designs and loads are available from this company. 
         [0054]    When a snap dome with lobes (see  FIG. 2 ) is used in a stack for the upper and/or lower load, the lobes must be aligned with each other as shown at  28  in  FIGS. 4 and 5  for the stack to work properly. Furthermore, for the embodiments shown in  FIGS. 1 ,  3 ,  4  and  5 , the lobes of the upper and the lower snap domes (or stacks) should be offset with respect to each other, for optimal performance of the device. Or else the lobes will interfere with each other due to their collision preventing the apex of the snap dome from reaching the neutral plane coincident with the lobes of the same snap dome, if a plate is placed between the two individual or stacked domes, the bent ends of the domes will provide interference of a similar fashion. 
         [0055]    In practice, the mechanism of the present invention is meant to be placed inside a shoe or orthotic, e.g. in the heel area as shown in  FIG. 7 , so that the upper plate  12  may or may not come into direct contact with the wearer&#39;s heel or other area of the foot and the lower plate  14  will not come into direct contact with the ground. The forces, however, from the foot to the ground are transmitted through the device. 
         [0056]    Each snap dome  16  and  18  is preferably a thin dome-shaped disk of spring metal (e.g. stainless steel) or plastic which is shown in its stable condition in  FIGS. 1 and 3 , and, when receiving more than its design load, will snap-through to an unstable compressed condition. The domes operate in the same way as the bottom of an oil-can or lid of a canning jar. If sufficient downward force is exerted, the snap dome will snap or buckle into its unstable position shown, becoming now upwardly concave. If the force is removed, a restoring internal force, from a build-up of internal material strains similar to a compressed spring, will cause dome to return to its upwardly dome-shaped position of  FIGS. 1 and 3 . The upper plate  12  and lower plate  14  are made of any suitable material, for example, hard ABS plastic, metal or the like. 
         [0057]    Plates  12 , 14  are approximately 3 to 5 cm in diameter to fit comfortably in a patient&#39;s shoe or medical appliance. Varying thicknesses, material and geometry (i.e., radius of curvature, height, diameter) of each dome  16  and  18  can be selected so that they collapse or buckle to their unstable conditions under different, but specifically selected, forces corresponding to minimum and maximum weights or load desired for the user&#39;s heel. The material of each dome may be any spring-like metal such as steel or other metal alloy, having high tensile strength, or may be plastic capable of having the stable and unstable positions, such as nylon. The overall height of the device  10  should be approximately 0.6 to 1.2 cm so that it can be received in the shoe, medical appliance, or orthotic without obstruction. 
         [0058]    As noted above, no power source is needed and the invention automatically resets once the load has been removed. 
         [0059]    A second embodiment of the invention is illustrated in  FIGS. 4 and 5  where rather than two single snap domes  16  and  18 , at least one of the domes or both of them are replaced by one or two stacks  26  and  28  of at least two snap disks for each dome. A stack of identical domes buckles at the combined buckling loads of the individual domes. Instead of the medical professional having to stock an assortment of domes or disks depending on the load range required for their patient, they would only stock one load disk of, for example 10 or 20 lbs. If the desired minimum load range were 40 to 100 lbs, as before, the medical professional would stack two 20-lb disks (40 lbs total) concave up under the upper transfer plate  12 , and three more 20-lb disks (for a total of 100 lbs) concave down on the base plate  14 . The stack  26  of two snap domes would be the first to buckle when the limb load exceeds 40 lbs, followed by the stack  28  of three snap domes buckling when the limb load rises an additional 60 lbs to reach the desired maximum of 100 lbs. The stock domes can also be pre-packaged depending upon patients weight range. 
         [0060]    A third embodiment of the invention is illustrated in  FIG. 6 . 
         [0061]    It is noted that in a preferred form of the invention as shown in all of  FIGS. 1 ,  3 ,  4 ,  5  and  6 , the load transfer plate  12  has a center post  30  to retain the lateral positions of both dome stacks. All snap domes in these embodiments will have the central hole  24  (see  FIG. 2 ). This post  30  rides in a hole  32  provided in the base plate  14  as the plates are force toward each other during each step the user takes. The load transfer plate  12  will also be covered with a low-durometer foam or polymeric gel material, if needed. 
         [0062]    Assembly of all the components is facilitated by a snap fit between the load transfer plate  12  which, as shown in  FIG. 6  has multiple, e.g. four, retaining legs  40  that are evenly spaced around the plate  12  and embrace the base plate  14 . Four support tabs guide the load transfer plate. 
         [0063]      FIG. 7  shows the embodiment of  FIG. 6  installed in the heel of a shoe  60  but it will be understood that any embodiment of the invention as illustrated here or to be developed in the future can be installed in any part of footwear to be used with the present invention. 
         [0064]    A fourth embodiment of the invention is illustrated in  FIGS. 8 and 9  and uses low and high load domes  54  and  52  respectively, that are integrated into a single component  50  shown in the un-loaded position in  FIG. 8 . This dual snap dome is custom manufactured and includes a large diameter dome  52  that is in contact with the base plate  14 , and a smaller snap dome  54  whose apex is in contact with the load transfer plate  10 . When the lower desired load is reached, part  54  will buckle signaling the wearer via an audible click and a tactile sensation under the foot. When the upper desired load is reached, part  52  will buckle with the smaller diameter part  54  still in its compressed condition and, again, signaling the wearer with a lower-pitched audible click and tactile sensation under the foot. 
         [0065]    A fifth embodiment of the invention is illustrated in  FIGS. 10 and 11 , which is very similar to the fourth embodiment except that the smaller diameter dome  56  is a separate part that nests in a recess at the apex of the large diameter dome  52  of the two-part dome  50 . 
         [0066]    Other non-limiting embodiments of the invention are shown in  FIGS. 12 to 27 . 
         [0067]    In these embodiments a separator plate  62  is provided between the load transfer plate  12  and base plate  14  in each case, and in each case, between the two single domes ( 16  and  16 ), two dome stacks ( 28  and  28 ), or single dome and a dome stack ( 16  and  28 ). In this way the two domes, two dome stacks, or single dome and dome stack that provide the lower and the upper load signal, can be oriented to be both concave up as in  FIGS. 12 to 15 , or concave down as in  FIGS. 16 to 19 , or concave away from each other as in  FIGS. 20 to 23  (which was also the case in  FIGS. 1-4  except without the plate  62 ), or concave toward each other as in  FIGS. 24 to 27 . 
         [0068]    While specific embodiments of the invention have been shown and described in detail to illustrate the application of the principles of the invention, it will be understood that the invention may be embodied otherwise without departing from such principles.