Abstract:
A method to and apparatus to prevent injury and infection of a health-care recipient as a result of anticipated possible complications associated with any ones of a predetermined plurality of health-care procedures. The invention provides specific unambiguous warning indications prohibiting one or more of the aforementioned procedures on the outer surface of a physical barrier which is placed onto said health-care recipient in such a way that the indications are clearly visible. The presence of said barrier is designed to significantly interferes with any reasonable application said plurality of procedures on said recipient.

Description:
RELATED APPLICATIONS  
       [0001]    This application is a continuation of provisional application Ser. No. 60/090,615 filed Jun. 25, 1998.  
     
    
     
       FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT  
         [0002]    Not Applicable.  
         BACKGROUND OF THE INVENTION  
         [0003]    This invention relates to the field of health care, and specifically to the use of coverings for limbs and other selected body parts to warn and prevent health care providers from inadvertently causing injury or infection to same limbs and selected body parts.  
           [0004]    This invention relates to use in hospitals, acute care centers, emergency rooms, doctor&#39;s offices, nursing homes, convalescent hospitals, field hospitals, and all other medical, nursing, and health-care facilities.  
           [0005]    There are many situations where a body part or extremity must be protected from such a hospital procedure. For example, many women being treated for breast cancer have had the lymph nodes under their arms removed. As a result, because of the risk of developing lymphedema, the arm which no longer has lymph nodes can never be used for intravenous cannula hook-ups, injections, or blood pressure readings.  
           [0006]    At the present time, the most commonly used technique for alerting medical personnel to this condition is through the use of a temporary, handwritten note or sign which is typically taped on the wall over a patient&#39;s bed. This procedure is fraught with obvious failings: the sign may fall off the wall; it may not be seen; it may be ignored or lost in the clutter; it may be misunderstood or misinterpreted; it may contain incorrect information; and, it may not even be posted at all. Furthermore, a patient may be transported from one room to another, and the warning sign may be left behind.  
         SUMMARY OF THE INVENTION  
         [0007]    It is an object of the present invention to specifically cover and protect a user&#39;s limb and/or other body part(s).  
           [0008]    It is another object of the present invention to specifically prohibit a health-care provider from providing particular health-care or medical procedures to the user.  
           [0009]    It is another object of the present invention to prevent and/or make very difficult particular predefined medical or health-care procedures from being performed on the user&#39;s covered and protected body parts.  
           [0010]    It is another object of the present invention to prevent injury to the user&#39;s body parts protected by the present invention by preventing easy access to same for medical or healthcare procedures.  
           [0011]    It is another object of the present invention to reduce risk of infection to same protected body parts by preventing easy access to same for medical or health-care procedures.  
           [0012]    It is another object of the present invention to force a health-care provider or medical person to explicitly and pro-actively do something in order to circumvent the protection afforded by the present invention in use.  
           [0013]    It is another object of the present invention to permit detection of the circumvention of the present invention in use.  
           [0014]    These and other aspects and attributes of the present invention will be discussed with reference to the following drawings and accompanying specification.  
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0015]    [0015]FIG. 1 is an illustration of one embodiment of the present invention as used on a person.  
         [0016]    [0016]FIG. 2 is an illustration of a blood pressure warning graphic and text associated with one embodiment of the present invention.  
         [0017]    [0017]FIG. 3 is an illustration of an injection warning graphic and text associated with one embodiment of the present invention.  
         [0018]    [0018]FIG. 4 is an illustration of an intravenous warning graphic and text associated with one embodiment of the present invention.  
         [0019]    [0019]FIG. 5 is an illustration of one embodiment of the present invention as used on a person&#39;s arm.  
         [0020]    [0020]FIG. 6 is an illustration of one embodiment of the present invention as used on a person&#39;s leg.  
         [0021]    [0021]FIG. 7. is an illustration of one embodiment of the present invention as used on a person&#39;s arm and shoulder.  
         [0022]    [0022]FIG. 8 is an illustration of one embodiment of the present invention as used on a person&#39;s ear.  
         [0023]    [0023]FIG. 9 is an illustration of one embodiment of the present invention as used on a person&#39;s feet.  
         [0024]    [0024]FIG. 10 is an illustration of one embodiment of the present invention as used on a person&#39;s arm and upper chest.  
         [0025]    [0025]FIG. 11 is an illustration of a intravenous warning graphic associated with one embodiment of the present invention.  
         [0026]    [0026]FIG. 12 is an illustration of a temperature warning graphic associated with an embodiment of the present invention.  
         [0027]    [0027]FIG. 13 is an illustration of a hypodermic warning graphic associated with an embodiment of the present invention.  
         [0028]    [0028]FIG. 14 is an illustration of a blood pressure warning graphic associated with an embodiment of the present invention.  
         [0029]    [0029]FIG. 15 is an illustration of a moisture warning graphic associated with an embodiment of the present invention.  
         [0030]    [0030]FIG. 16 is an illustration of a bright-light warning graphic associated with an embodiment of the present invention.  
         [0031]    [0031]FIG. 17 is an illustration of a one embodiment of the present invention in the process of being applied to a person&#39;s arm.  
         [0032]    [0032]FIG. 18 is an illustration of a one embodiment of the present invention having completed the process of being applied to a person&#39;s arm.  
         [0033]    [0033]FIG. 19 is an illustration of a one embodiment of the present invention as a single-ended cylindrical pocket.  
         [0034]    [0034]FIG. 20 is an illustration of a one embodiment of the present invention as a double-ended cylindrical sleeve.  
         [0035]    [0035]FIG. 21 is an illustration of another embodiment of the present invention as a double-ended cylindrical sleeve including tie straps.  
         [0036]    [0036]FIG. 22 is an illustration of a one embodiment of the present invention as a double-ended conical sleeve.  
         [0037]    [0037]FIG. 23 is an illustration of an alternate embodiment of the present invention as a shirt.  
         [0038]    [0038]FIG. 24 is an illustration of another alternate embodiment of the present invention as a warning patch with tie straps.  
         [0039]    [0039]FIG. 25 is an illustration of one embodiment of the present invention supplied as a continuous roll.  
         [0040]    [0040]FIG. 26 is an illustration of an alternate embodiment of the present invention including a battery-operated warning light.  
         [0041]    [0041]FIG. 27 is an illustration of another embodiment of the present invention which incorporates a support structure and an alternate fastening means.  
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0042]    While this invention is susceptible of embodiment in many different forms, there is 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 disclosed embodiments.  
         [0043]    The present invention provides a barrier, both physically and with a warning (visual, audible, etc.) to prevent access to a particular part of a patient, so as to inhibit access to the particular part of the patient to provide a barrier to a medical health care procedure. Various embodiments of the barrier include sleeves (arms, legs, etc.), vests (shoulder, chest, etc.), pockets (hands, feet, ankles, etc.), covers (ears, nose, face), screens, wraps, and others.  
         [0044]    In accordance with a first embodiment of the present invention, a sleeve is designed to shield, cover or protect an arm, hand, leg, foot, or any other body part or collection of body parts from a needle injection, intravenous hook-up, blood pressure reading, temperature measurement, or another similar medical procedure. (See FIG. 1, FIGS.  5 - 10 , and FIGS.  17 - 18 .)  
         [0045]    The safety sleeve embodiment of the present invention, once applied to the patient as a barrier to a medical health care procedure, eliminates the problems associated with the prior art methods. Through the use of bright colors and descriptive graphics (similar to the familiar “no smoking symbol”) emblazoned upon it, the present invention would automatically alert any medical staff member that the covered body part is not to be used for any such medical procedure.  
         [0046]    Some of the more common medical procedures are identified in FIGS.  2 - 4  and FIGS.  11 - 16 . FIGS. 2 and 14 illustrate alternate embodiments of warning indications for various graphics alerting medical staff that taking a blood pressure reading, and/or using a blood pressure cuff, on the relevant users&#39; body part(s) is prohibited. The graphical warning may be supplemented by a textual description or prohibition. Additionally, the textual warning may be supplied in more than one language.  
         [0047]    [0047]FIGS. 3 and 13 illustrate alternate embodiments of warning indication graphics alerting medical staff that injecting material, and/or using a hypodermic needle, on the relevant users&#39; body part(s) is prohibited. The graphical warning may be also be supplemented by a textual description or prohibition. As before, the textual warning may be supplied in more than one language.  
         [0048]    [0048]FIGS. 4 and 11 illustrate alternate embodiments of warning indication graphics alerting medical staff that drawing material, or using a cannula, on the relevant users&#39; body part(s) is prohibited. The graphical warning may be also be supplemented by a textual description or prohibition. As before, the textual warning may be supplied in more than one language.  
         [0049]    [0049]FIG. 12 illustrates an embodiment of a warning indication graphic alerting medical staff that taking or monitoring a temperature of the relevant body part is prohibited.  
         [0050]    [0050]FIG. 15 illustrates an embodiment of a warning indication graphic alerting medical staff that moisture on of the relevant body part is prohibited.  
         [0051]    [0051]FIG. 16 illustrates s an embodiment of a warning indication graphic alerting medical staff that bright light is to be avoided.  
         [0052]    The actual graphic images used in accordance with the invention are not limited to the examples shown. Additionally, images (preferably that have been tested to be readily discernable by the medical profession) could supplement or replace the examples shown herein. Any image may be supplemented by textual warnings, and the warnings may appear in any number of languages.  
         [0053]    In an alternate embodiment of the invention, the textual warnings stand-alone and are used in lieu of graphic images.  
         [0054]    The warning indication graphic images can be one or more of graphics, icons, pictographs, and other visual, audible, or other method or means used to convey information regarding prohibited medical procedures to medical staff.  
         [0055]    In an alternate embodiment as shown in FIG. 26, the invention incorporates an indicator  300  that lights up to draw attention to the warning  305 . One of the simplest embodiments is the use of a small battery operated flashing light-emitting diode (LED); such a device could run for weeks on a single battery  310 . Other embodiments may include incandescent bulbs, neon or other rare-gas bulbs, and others familiar to one skilled in the arts.  
         [0056]    An alternate embodiment features glow-in-the-dark material on the warning, such that the warning would be visible in darkness or near darkness.  
         [0057]    In all embodiments, the warning may be affixed to, woven into, painted or printed on, or otherwise made part of or visible from at least one surface of the safety sleeve or other barrier in accordance with the present invention. The key attribute of the warning is that it should provide a specific unambiguous warning indication, to clearly indicate to a healthcare provider or medical staff, that specific medical procedures are to be prohibited on the protected body part.  
         [0058]    In a preferred embodiment, more than one warning may be visible on the safety sleeve or other barrier embodiment In this embodiment, each warning is a clear indication of a specific medical procedure that is prohibited for the protected body part. As a result, this embodiment of the invention simultaneously prohibits a plurality of different medical procedures.  
         [0059]    In use, multiple instances of the safety sleeve or other barrier embodiment may be used on one patient simultaneously, generally on different body parts. It is also possible to use multiple safety sleeves on one specific body part.  
         [0060]    The barrier can be made out of inexpensive, disposable material that is durable enough to remain in place without easily tearing, but flexible enough not to cause any discomfort or pain. Materials suitable for construction of the present invention include paper, cotton, cloth, gauze, silk, plastic, latex, rubber, polyester, Nylon™, Kevlar™, Dacron™, Spandex™, Lycra™, Tyvek™, and other similar materials. The materials can alternatively be chosen for reusability, as durable and washable materials.  
         [0061]    In a preferred embodiment, the materials selected for construction would permit easy sterilization of the invention prior to use.  
         [0062]    [0062]FIG. 1 is an illustration of various embodiments of the present invention as used on a person. Two safety sleeve barriers are shown; one barrier  110  is present on one arm  101  of a person  100 , and one barrier  120  is on one leg  102  of a person  100 . One safety packet  130  is on one foot  103 .  
         [0063]    [0063]FIG. 5 is an illustration of one embodiment of a barrier sleeve  140  with warning indication  145  as used on a person&#39;s arm  101  including an elbow  104  but excluding both the hand  105  and shoulder  106 .  
         [0064]    [0064]FIG. 6 is an illustration of one embodiment of a barrier sleeve  150  with warning indication  155  on a viewable surface as used on a person&#39;s leg  102 , including the knee  107  and excluding the pelvis  108  and foot  103 .  
         [0065]    [0065]FIG. 7 is an illustration of one embodiment of a barrier  160  having a warning indication graphic  165  in accordance with the present invention as used on a person&#39;s arm  101  and shoulder  106 . This embodiment also illustrates the use of a strap  162  or belt to hold the upper portion of the sleeve in place. The illustrated embodiment has an opening at the bottom end permitting access to the patient&#39;s hand  105 . In an alternate embodiment, the bottom may be sealed thus preventing access to the patient&#39;s hand.  
         [0066]    [0066]FIG. 8 is an illustration of one embodiment of a barrier  170  having warning indication  175  in accordance with the present invention as used on a person&#39;s ear  109 . This embodiment also illustrates the use of straps or belts  180  to hold the surface of the protective cover in place. In a preferred embodiment, the straps would be constructed of a stretchable and breathable fabric such as an elastic weave.  
         [0067]    [0067]FIG. 9 is an illustration of one embodiment of a barrier  190  having warning indication  195  in accordance with the present invention as used on a person&#39;s feet  103 . FIG. 9 shows the use of two pockets  190 , one on each foot  103 , wherein the safety sleeve  190  is closed on the bottom end  191 . Each foot  103  is thus protected from the ankle  103   a  on down to the bottom end  191 .  
         [0068]    [0068]FIG. 10 is an illustration of one embodiment of a barrier  200 ,  201  having warning indication  205  in accordance with the present invention as used on a person&#39;s arm  101  and upper chest  111 . This illustration shows two safety sleeves  200 , 201  of differing design connected via fasteners to form a continuous safety covering.  
         [0069]    [0069]FIG. 17 is an illustration of a one embodiment of a barrier wrap  210  having warning indication  215  in accordance with the present invention in the process of being applied to a person&#39;s arm  101 . The safety sleeve is shown in the open configuration with fastener means  212  shown, with the arm  101  placed into the center of the sleeve, before the safety sleeve is closed around the patient&#39;s arm.  
         [0070]    FIGS.  18 - 24  show various embodiments of the present invention including the warning present on the outer surface of the safety sleeve. FIG. 18 illustrates the barrier wrap  210  of FIG. 17, having completed the process of being applied to a person&#39;s arm and being in the closed position or configuration. The safety barrier warp sleeve  210  is shown in the closed configuration, with the arm  101  encircled by the safety sleeve.  
         [0071]    Note that FIGS.  17 - 18  illustrate one seam in the safety sleeve  210 . In a preferred embodiment, no seam is present, and the safety sleeve represents a continuous unbroken cylinder as shown in FIGS.  19 - 20 . In another embodiment, the safety sleeve may have a plurality of seams, each with their own respective fastening means.  
         [0072]    [0072]FIG. 19 is an illustration of one embodiment of a single-ended cylindrical pocket barrier  230  with warning indication  235 , suitable for use on a patient&#39;s limb or other extremity.  
         [0073]    [0073]FIG. 20 illustrates one embodiment of a double-ended cylindrical sleeve barrier  240  with warning indication  245 , suitable for use on an elbow, wrist, knee, or ankle joint. A larger version of the embodiment shown in FIG. 20 is suitable for use on a torso.  
         [0074]    [0074]FIG. 21 is an illustration of another embodiment of a double-ended cylindrical sleeve barrier  250  having warning indication  255  including tie straps  256  to assist the positioning and placement of the safety sleeve  250 .  
         [0075]    [0075]FIG. 22 is an illustration of a one embodiment of a double-ended conical sleeve barrier  260  with warning indication  265 . This shape is more suitable for some patients to protect lower extremities such as a complete leg.  
         [0076]    [0076]FIG. 23 is an illustration of an embodiment of a shirt barrier  270  having warning indication, comprising holes for arms  271 , neck  272 , and torso  273 .  
         [0077]    [0077]FIG. 24 is an illustration of an alternate embodiment of a warning patch barrier  280  with warning indication  285  with tie straps  286 . This embodiment is suitable for very small areas that need protection that would be otherwise difficult to encompass by the other embodiments.  
         [0078]    [0078]FIG. 25 is an illustration of one embodiment of the present invention wherein the barrier is initially supplied as a continuous roll  290 . A number of segments  291  of safety sleeve are constructed with perforations separating each segment from the next, and the segments are rolled for distribution. In use, the user would select the number of segments required and tear off that length from the roll, thus reducing waste.  
         [0079]    The sleeve would remain in position on a patient through the use of any of the following devices, including self-adhesive strips, hook and loop fasteners, buttons, zippers, hooks and eyes, ties, buckles, belts, pins, string, elastic bands, rubber bands, snaps, clasps, Velcro™ tape fasteners, or any other clasping, fastening, or adhesive device.  
         [0080]    The fasteners may be used to fasten solely to other portions of the safety sleeve. In a preferred embodiment, the fasteners may alternatively fasten to elements of the patient&#39;s existing clothing, thus permitting additional ease of installation and use of the invention. In an alternate embodiment, the invention may be fastened directly to the patient&#39;s skin, using suitable adhesives well-known to those in the medical profession.  
         [0081]    In a preferred embodiment, the invention includes a means to detect if the invention has been removed and/or opened at any time during its use. This detection means may utilize any of fragile tape, single-use stickers, color-change chemicals, phase-change chemicals, a mechanical indicator, limit switches, or a position sensor. If the invention has been opened or removed at any time, the detection means provides obvious and unchangeable evidence of such tampering. In one preferred embodiment, the detection means provides an alarm trigger output, which can be used to alert medical or nursing staff at a monitoring station or within some signalling range that the invention has been tampered with.  
         [0082]    In addition to tampering and removal, one embodiment of the present invention permits detection of unusual attributes such as elevated or depressed temperature, high or low pH values, presence or absence of moisture, and so on. Additionally, in another embodiment motion inside the safety sleeve can be detected. A different embodiment of the invention permits sensing of blood oxygenation level. Each of these attributes may be used to trigger an alarm or as a data input to an external medical system.  
         [0083]    In an advanced embodiment, the safety sleeve includes motion and/or proximity sensors, using any conventional sensing means known to those skilled in the arts, including active and passive infrared (IR), ultrasonic, trembler, and vibration sensors. These sensors may trigger an alarm within some signalling range indicating attempted access or tampering with the safety sleeve by someone external to the patient  
         [0084]    In a preferred embodiment, the material of the safety sleeve is flexible, lightweight, inexpensive, sterile, and disposable. In one embodiment, the safety sleeve may be one of water-resistant, water-proof, or water-tight. In another embodiment, the safety sleeve may be gas-tight permitting air pressurization or vacuum.  
         [0085]    In one embodiment, as shown in FIG. 27, the safety sleeve incorporates internal support structures to permit the sleeve to maintain a shape or profile independently of the patient&#39;s body part. These supports may include ribs, rings, stays, splints, restraints, air cushions, water cushions, aerogels, braces, and/or supports. As shown in FIG. 27, support ribs  330  may be affixed to the safely sleeve barrier wrap  210  by means of stitches  335  or other attachment means. Alternatively, the support ribs may be formed as an integral part of the safety sleeve barrier wrap  210 . In the illustrated embodiment, self-adhesive tabs  340  are shown to fasten the safety sleeve in place.  
         [0086]    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. It is to be understood that no limitation with respect to the specific apparatus illustrated herein is intended or should be inferred. It is, of course, intended to cover by the appended claims all such modifications as fall within the scope of the claims.