Abstract:
A device for evaluating loss of protective sensation, which comprises a probe mounted on a head that is pivotally attached to a handle member, is provided. The handle member has a protective channel. When the head is pivoted so that the device is operative, the probe extends outwardly from the handle member. When the head is pivoted into a closed position, the probe is stored within the protective channel.

Description:
FIELD OF THE INVENTION 
     The present invention relates to a device used by health care providers for detecting patients&#39; loss of protective sensation. More particularly, it relates to an improved monofilament-type device used for this purpose. 
     BACKGROUND OF THE INVENTION 
     Protective sensation, or ability to feel pain, is a warning system that enables an individual to avoid injury and that alerts the individual when injury does occur. Certain neurological and other medical examinations require the detection of impaired or lost sensitivity. Such detection is particularly important for patients with certain diseases or disabilities. For example, nearly half of all diabetes patients in the United States develop diabetic neuropathy, a complication that suppresses a patient&#39;s ability to feel pain. Diabetic peripheral neuropathy is characterized by loss of protective sensation, which may be manifested as analgesia (absence of pain or touch sensitivity), hyposthesia (reduced sensitivity), weakness, or autonomic changes. Loss of protective sensation is that degree of sensory loss that permits cutaneous injury to occur without being perceived by the patient as painful. 
     When due to neuropathy, loss of protective sensation is a major permissive factor in the pathogenesis of foot injury, and often leads to ulceration, infection, and, potentially, amputation. These problems are significant: Approximately 15% of diabetes patients sustain foot or leg ulcers, and may reacquire them in the absence of preventive and protective intervention. In addition, diabetic foot ulcers account for more than 20% of total hospital days for patients with diabetes, and they are the leading cause of hospital admissions for diabetic patients. Approximately 50% of all nontraumatic amputations in the United States are caused by complications from diabetes. 
     Routine testing for loss of protective sensation is critical, particularly for atrisk patients, such as those with diabetes. Prior art devices, however, are cumbersome and relatively expensive, and thus hinder such routine testing. For example, the device disclosed by Low et. al, U.S. Pat. No. 3,662,744, issued May 16, 1972, telescopically extends and retracts a monofilament. This device requires the health care practitioner to turn a knob to extend the monofilament each time the device is used, to ensure the proper length of monofilament is extended from the device, and to turn the knob to retract the monofilament when done. Because the length of monofilament extended from the device is variable, the health care practitioner has difficulty knowing how much force is being exerted by the monofilament on the patient. The device also has many moving parts, and thus is relatively costly to manufacture. 
     The Semmes-Weinstein esthesiometer, which currently is in widespread use, also has disadvantages. The Semmes-Weinstein device consists of a monofilament that is permanently attached at a 90 degree angle to the end of a plastic rod. The monofilament is always exposed, and thus is prone to damage. To compensate, the device generally is kept in a protective case in a drawer. The result is that the device is often not conveniently accessible to the health care provider, and thus is not used on a consistent basis. 
     There is an unmet need for a device for evaluating protective sensation that is convenient to carry and easy to operate and clean, thereby enabling health care practitioners to evaluate routinely whether their patents have lost protective sensation. Such a device preferably also will be inexpensive, small, and lightweight. 
     SUMMARY OF THE INVENTION 
     The present invention relates to a device that tests for loss of protective sensation. The device has a probe, preferably a monofilament, with a stimulating tip at one end. The other end of the probe is attached to a pivoting head, which itself is mounted toward the end of a handle member. When the head is pivoted into its open position, the probe extends outwardly (and, preferably, generally perpendicularly) from the handle member. In this position the device is operational. When the head is rotated into the closed position, the probe is moved into a protective channel in the handle member. A pocket clip is provided to assist in making the device easy to carry. 
     A primary object of the present invention is to provide a device for testing for loss of protective sensation that is easily opened for operation and closed for storage. A further object of the present invention is to ensure that the probe is protected when the device is in the closed position. Another object of the present invention is to provide a testing device that is small, light, and easy to carry. Still another object of the present invention is that the device be inexpensive and simple to manufacture. It is yet another object of the present invention that the device be easy to clean, and thus reusable. 
    
    
     These and other objects of the present invention will become apparent with reference to the drawings, the description of the preferred embodiment, and the appended claims. 
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is an isometric view of the present invention in its open state. 
     FIG. 2 is an isometric view of the present invention in its closed state. 
     FIG. 3 is a fragmentary front elevational view of the present invention in its open state with portions shown in phantom. 
     FIG. 4 is a fragmentary front elevational view of the present invention in its closed state with portions shown in phantom. 
     FIG. 5 is a fragmentary side elevational view. 
     FIG. 6 is an isometric view showing the present invention in use. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     FIG. 1 depicts the sensitivity-testing device  10  of the present invention. The device  10  has a handle member  12 , which is made of a generally rigid material, such as plastic. The handle member  12  has a grip portion  13  and an extension portion  15  with a channel  14  that extends from the pivot end  30  of the handle member  12  to a point located approximately midway along the handle member  12 . A pocket clip  16  is located at the grip end  32  of the handle member  12 . The handle member  12  and clip  16  preferably are formed into a single, continuous piece. The grip portion  13  has grip ridges  18  opposite the clip  16 . In addition, the clip  16  has clip ridges (reference numeral  19  in FIG. 5) on its exterior surface. The clip ridges  19  and grip ridges  18  provide the health care practitioner a comfortable and secure grip. 
     A pivoting head  20  is positioned at the pivot end  30  of the handle member  12 . The head  20  preferably is made of a plastic material, and it has head ridges  22  on its back. A probe  24  is permanently inserted into the front of the head  20 . The probe  24  preferably is a monofilament that is relatively stiff but flexible. The preferred monofilament is generally cylindrically shaped, is approximately 38.5 millimeters in length, and is approximately 0.017 inches in diameter. The monofilament used in the present invention preferably is made of a polymeric material such as nylon. The monofilament that is preferred for the present invention has a filament index number of 5.07, and is available as Nylon 612 from DuPont. In use, a probe  24  of the preferred type applies a force to the patient&#39;s skin of 10 grams; when more than 10 grams of force is applied by the health care practitioner, the probe  24  bends, and eventually will slip off the user&#39;s skin or kink. By using a thicker or shorter probe  24 , the device  10  can be made to exert greater force on the patient&#39;s skin. Conversely, when a thinner or longer probe  24  is used, the device  10  will exert less force on the patient&#39;s skin. 
     FIG. 1 depicts the device  10  of the present invention in its open position; i.e., the probe  24  is depicted extending outwardly from the handle member  12 . FIG. 2 depicts the device  10  in its closed position; i.e., the front of the head  20  has been rotated approximately  90  degrees toward the grip end  32  of the handle member  12 ,and the probe  24  thereby has been moved entirely into the channel  14 . 
     As can be seen in FIG. 3, the handle member  12  is bent at a relatively small angle  26  midway along its length. When the health care practitioner holds the device  10  in a natural, comfortable manner, the angle  26  ensures that the probe  24  is in the optimal position for testing cutaneous sensitivity. The angle  26  also makes the device  10  more ergonomically comfortable for the practitioner. This angle  26  is between 0 degrees and about 30 degrees, is preferably between 0 degrees and about 15 degrees, and most preferably is about 6 degrees. The head  20  is held in place by pins  28 , which may extend completely through the head  20 , but preferably are only stub pins that extend from and are formed integrally with the inner surface of the channel  14 . Stub pins are preferable because they permit the head  20  to be snapped into place at the pivot end  30  of the handle member  12 . 
     FIG. 4 depicts the device  10  in its closed position. It can be seen that, when the device  10  is closed, the probe  24  is located entirely within the protective channel  14 , and thus is out of harm&#39;s way. Its nature also is concealed from the patient, who will then have no preconceived notions about the sensation he or she soon may feel. This helps ensure an unbiased response. 
     FIG. 5 depicts the clip  16  used with the present invention. The clip  16  preferably is formed from the same material as that used for the handle member  12 . FIG. 5 depicts the clip  16  in its relaxed state, as shown by the solid lines. The position the clip  16  may assume in use is shown in phantom. 
     The use of the present invention now will be described. To open the present invention, the health care practitioner rotates the head  20  so that the probe  24  extends outwardly from the handle member  12 . This can be done with a single hand, simply by flipping the head  20  with a thumb. In use, the probe is opened and applied perpendicular to the skin, out of the patient&#39;s sight. The health care practitioner applies enough force to the handle member  12 , and thereby against the patient&#39;s skin, to bend the probe  24  for approximately 1.5 seconds. As can be seen in FIG. 6, when force is applied against the patient&#39;s skin, the probe  24  will bend. Patients who cannot feel the kind of pressure applied by the device  10  have lost protective sensation, and are at increased risk for injuries that may lead to neuropathic ulcers. Upon detection of a patient&#39;s loss of protective sensation, proper medical treatment may be prescribed. After using the device  10 , the health care practitioner may clean the probe  24  by wiping it with alcohol or by washing it with detergent and water. The device  10  is closed simply by rotating the head  20  with a thumb. 
     Although the description of the preferred embodiment has been presented, it is contemplated that various changes may be made without deviating from the spirit of the present invention. Accordingly, it is intended that the scope of the present invention not be limited strictly to that of the description of the preferred embodiment of the present invention.