Patent Publication Number: US-11653994-B2

Title: Therapeutic skin lifting device and related systems and methods

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 15/067,132, filed Mar. 10, 2016, which is a continuation-in-part of U.S. patent application Ser. No. 13/825,759, filed on Mar. 22, 2013, which is National Phase Patent Application and claims priority to and the benefit of International Application Number PCT/US2013/28099, filed on Feb. 27, 2013, which claims priority to and the benefit of U.S. Provisional Application No. 61/685,545, filed on Mar. 20, 2012; U.S. Provisional Application No. 61/685,752, filed on Mar. 22, 2012, and U.S. Provisional Application No. 61/690,106, filed Jun. 19, 2012, the entire contents of all of which are incorporated herein by reference. 
    
    
     FIELD OF INVENTION 
     The present invention relates to a medical device for reducing symptoms of physical ailments and conditions, including pain and discomfort associated with Carpal Tunnel Syndrome (CTS), migraine headaches and other pressure-related ailments and conditions. 
     BACKGROUND 
     Carpal Tunnel Syndrome (CTS) is idiopathic median neuropathy at the carpal tunnel of a human hand. With reference to  FIG.  1   , a human hand  100  is illustrated with muscles in a proximate portion, below thumb  106  and pinky finger  108 , including abductor pollicis brevis  102  and abductor digit minimi  104 , respectively. The muscles  102  and  104  define transverse carpal arch  110  with a recess  112  therebetween that is generally aligned with third finger  114 . In tissues below the recess  102  is carpal tunnel  116  where median nerve  118  enters the hand  100 . This tunnel is normally narrow as it is also occupied by flexor tendons  120 , so any swelling of adjacent tissue, including the flexor retinaculum ligament  122 , can pinch the nerve and cause pain, numbness, tingling or weakness. 
     The pathology of CTS is not completely understood but can be considered compression of the median nerve traveling through the carpal tunnel. Many studies have been conducted to identify causes but the evidence is not clear. Various results published in the 1990&#39;s found strong associations between the prevalence of CTS and forceful and repetitive wrist movements such as work on keyboard and computers. However, more recent research has cited genetics and obesity as possibly larger factors than use, and has encouraged caution in ascribing causality. 
     Pregnant women, especially those in their third trimester, may experience hand pain and discomfort, for example, numbness, tingling sensation, or aching in the hands and wrists, particularly at night when bodily fluids are more equally distributed throughout the body and not just in the lower extremities. Because pregnancy causes swelling in many parts of the body, extra pressure may be present on the nerves in the hands and wrists, including the median nerve. 
     The only scientific established disease modifying treatment is surgery to cut or divide the transverse carpal ligament. However, one study found that within two years of surgery, 75% of the patients showed recurrence of pain symptoms. Moreover, surgery has many risks and is not suitable for temporary CTS, such as that experienced by pregnant women. Palliative treatments for CTS include use of night splints and corticosteroid injection. Other nonsurgical treatment methods include hand braces, exercises, ergonomic equipment, oral diuretics and nonsteroidal anti-inflammatory drugs (NSAIDs). Websites including www.mycarpaltunnel.com discusses different treatment options. Other approaches include gloves, such as described in U.S. Pat. No. 6,006,751 and the prior art cited therein. Obviously, such gloves may be relatively expensive and are not disposable. Gloves may also limit manual dexterity and tactile sensitivity. 
     Kinesio tape has also been used as a nonsurgical treatment for CTS. Conventional kinesio tape is manufactured from a highly elastic strand wrapped in cotton fibers. It is employed as a gentle stretching therapy for soft tissue disorders and repetitive strain injuries. Kinesio tape has elasticity intended to match that of a person&#39;s skin, muscles, cartilage and connective fascia tissue. However, there are many different methods of taping around the hand and wrist and improper taping may cause further discomfort or even further damage to the median nerve. Moreover, proper taping often requires the use of two hands making it difficult if not impossible for a patient to apply the tape without assistance. 
     Hand braces and splints and temporary, removable devices worn on the hand are also known, for example, a stretching hand device described in U.S. Pat. No. 6,315,748 and sold under the mark THE CARPAL SOLUTION. The device includes a central, resilient, stretchable tensioning segment with a plurality of relatively less stretchable adhesive straps secured to the segment. In use, the segment is placed on the back of a patient&#39;s hand, whereupon the straps are pulled and adhered to the patient&#39;s palm in a fashion to expand the segment. In this orientation, the control segment exerts continuous yielding or tensile forces through the straps which in turn reduces carpal tunnel syndrome nerve compression and alleviates symptoms. 
     Another severe condition suffered by a significant portion of the population is migraine headaches. The pain of migraine occurs when excited brain cells trigger the trigeminal nerve to release chemicals that irritate and cause swelling of blood vessels on the surface of the brain. These swollen blood vessels send pain signals to the brainstem, an area of the brain that processes pain information. The pain of migraine is referred pain that is typically felt around the eye or temple area. 
     In addition to prescription and over-the-counter drugs, there are many remedies for migraines, including sleeping, taking caffeine, ice packs, and avoiding sunlight or certain foods. Kinesio tape has also been used to alleviate severe headaches. Experts believe that taping can significantly help reduce headaches by repositioning the muscles that are under stress and therefore helping to relieve tension in the neck. 
     Indeed, the adhesive tape or strips have many medical uses and applications beyond bandaging wounds. For example, nasal snoring strips are pieces of elastic plastic that are embedded in a sticking plaster for attachment across the outside of the nose. Shape-memory causes the plastic to straighten which effectively widens the nasal passages to allow for improved airflow. These strips are disposable and simplistic in design, construction and use. 
     Accordingly, there is a desire for a device that can reduce the symptoms of pressure-related conditions and ailments, including CTS and migraines. There is also a desire for the device to be simplistic in design, construction and use and be able to lift skin above a sensitive underlying site. 
     SUMMARY OF THE INVENTION 
     The device of the present invention is primarily intended for use in those suffering from Carpal Tunnel Syndrome (CTS), but also has application for relieving migraine headaches and other situations where lifting the skin and tissue above a sensitive underlying site would provide benefits. 
     The present invention provides for an inexpensive, reliable and easy to use device which lifts an area of skin upwardly in a direction generally perpendicular to the skin surface. It does not interfere with the sleep of the user and is a low cost disposable item. In a preferred embodiment, used for CTS, the device comprises a thin, generally rectangular member with a long dimension and a short dimension. The member is made from a plastic material, with “shape memory”, which in its normal configuration is generally flat. When pressure is applied orthogonally to the member, the member deforms. When released from pressure, the “shape memory” member has spring and rebounds to its normal configuration as much as possible. On a bottom (skin-facing) surface of the device, adhesive or adhesion member (used interchangeably herein) is provided on at least part of a central portion. A removable protective cover (e.g., release liner of wax paper) is applied over the adhesive. 
     In use, the protective cover is removed and the adhesive is applied to the palm proximate the wrist by a force depressing the center portion of the member toward the palm and fixes the center portion of the member to the palm. The member is oriented with the long dimension of the member across the palm between the thumb and the pinky finger. Since the adhesive is applied to a concave portion of the palm, the device forms a bridge across the palm. Side portions of the member supporting the center portion are not adhered to the palm so they can slide freely in contact with the palm. The skin of the palm adhering to the adhesive of the member is pulled upwardly as a result of negative pressure when the member is released and rebounds with its “shape memory”. 
     The adhesive can be applied to the device by any conventional means so that the adhesive remains on the member when the protective backing is removed. Alternatively, the adhesive can be applied by a user directly to the member or to the palm or skin of the user. Lifting and/or stretching the skin in the area of the palm or treatment site relieves symptoms, including the symptoms of CTS. 
     While a preferred embodiment envisions use of a single piece of spring-type plastic material, it is possible to incorporate other designs to provide a resilient or shape-memory member, such as synthetic whalebone, polyester boning material, metal, metal alloys, such as nitinol, and the like. 
     Accordingly, the present invention is directed a therapeutic device adapted for application to skin covering a treatment site on a patient&#39;s body, having a generally rigid but elastically deformable body with at least one support portion and a bridge portion, the support portion adapted to rest on the skin, the bridge portion having an adhesive adapted to adhere to at least a portion of the skin, wherein the body is adapted to assume a neutral configuration with the adhesive and the portion of the skin separated by an air gap, and an adhesion configuration with the portion of the skin adhering to the adhesive being lifted and/or stretched at the treatment site. The body is also adapted to assume a depressed configuration the wherein the body is deformed from the neutral configuration with the bridge portion being depressed to bring the adhesive into contact with the portion of the skin. 
     The body while in its neutral configuration supports the bridge portion at a highest elevation relative to the skin surface of the treatment site, where as the body while in its depressed configuration supports the bridge portion at a lowest elevation. Moreover, the body while in its adhesion configuration supports the bridge portion at an in-between elevation greater than the lowest elevation and lesser than the greatest elevation. The adhesive provided on an inner, skin-facing surface may include a coating or layer of adhesive material, double sided adhesive tape, at least one suction cup, and/or micro-suction cup tape. 
     In a more detailed embodiment, the therapeutic device has a thin sheet body with a “butterfly” configuration wherein the support portion supporting the bridge portion includes side planar portions adapted to rest on the skin. The butterfly configuration is well-suited for application to a palm of the patient&#39;s hand with the device positioned on the palm and the bridge portion longitudinally aligned with a median nerve of the palm. The adhesive is adapted for adhesion to skin below the device and above the median nerve. 
     The thin sheet body may also be configured rectangularly with rounded corners and one or more curved edges. As such, the device is also adapted for application on other areas of the patient&#39;s body. The rounded corners are atraumatic and the curved edge(s) accommodate features, curves and contours of the face or body, for example, nose, eyes, knuckles, elbows, knees and ankles. 
     In another more detailed embodiment, the therapeutic device has a thin sheet preformed body having an outer surrounding rim and a raised center bridge portion. The rim and the bridge portion may have a common shape, for example, circular, rectangular, square or polygonal. The bridge portion is supported by at least three legs extending upwardly from the rim. The preformed body is well-suited for application to a forehead, e.g., a temple region, of the patient. Each leg may be L-shaped including a radial leg portion and an axial leg portion. The radial leg portion extends between the bridge portion and the axial leg portion, and the axial leg portion extends between the radial leg portion and the outer rim. 
     In accordance with a feature of the present invention, the body of the device may have one or more predetermined curvatures in one or more directions. The curvature(s) serve to ensure that the bridge portion is elevated and separated from the skin below by an air gap when the device in its normal or neutral configuration. The curvature(s) also serve to strengthen the bridge portion against the pull of the adhered skin when the device has been depressed and applied to the treatment site and allowed to rebound to or toward its neutral configuration under its body&#39;s shape memory. In a more detailed embodiment, the bridge portion of the device has a curvature or concavity in at least one direction toward the inner, skin-facing surface. 
     The device may also be configured as a flexible band or sleeve or semi-rigid cuff to be worn on an appendage. The body is adapted to encircle or wrap around the appendage, e.g., an arm or a leg, with an inner, skin-facing surface having at least two projections or ridges with an adhesive positioned therebetween for adhesion to the skin, wherein the skin is lifted when adhered to the adhesive. 
     The present invention also includes a method and system for manufacturing the aforementioned therapeutic device. The manufacturing process includes: 
     1. A sheet of plastic material is passed through a heating tunnel to flatten or smooth the material. 
     2. The material is passed through rollers, for example, silicone coated rollers, to curve the material with a desired radius. 
     3. The material is passed through an adhesive applicator which applies adhesive, including adhesive tape, with or without a release liner. 
     4. The material is passed through a cutting chamber, for example a die set, which cuts bodies of the devices out of the material. 
     Sequence of the above steps may be varied as desired or appropriate. 
     The method of manufacturing may also include custom-fitting the therapeutic device by making a mold of a body part to be fitted with the device and customizing the die set to the mold. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       These and other features and advantages of the present invention will be better understood by reference to the following detailed description when considered in conjunction with the accompanying drawings. It is understood that selected structures and features have not been shown in certain drawings so as to provide better viewing of the remaining structures and features. 
         FIG.  1    is a perspective view of a hand with a cross-sectional view of a proximal portion including a median nerve and a carpal tunnel. 
         FIG.  2 A  is a top plan view of a therapeutic device, in accordance with one embodiment of the present invention. 
         FIG.  2 B  is a bottom plan view of the therapeutic device of  FIG.  2 A . 
         FIG.  2 C  is a lateral cross-sectional view of the therapeutic device of  FIG.  2 A , taken along line C-C. 
         FIG.  2 D  is a longitudinal cross-sectional view of the therapeutic device of  FIG.  2 A , taken along line D-D. 
         FIG.  3    is a top plan view of the therapeutic device of  FIG.  2 A , as applied to a user&#39;s palm. 
         FIG.  3 A  is a cross-sectional view of the therapeutic device of  FIG.  2 A , in a neutral configuration. 
         FIG.  3 B  is a cross-sectional view of the therapeutic device of  FIG.  2 A , in a depressed configuration. 
         FIG.  3 C  is a cross-sectional view of the therapeutic device of  FIG.  2 A , in an adhesion configuration. 
         FIG.  4 A  is a top plan view of a therapeutic device, in accordance with another embodiment of the present invention. 
         FIG.  4 B  is a bottom plan view of the therapeutic device of  FIG.  4 A . 
         FIG.  4 C  is a lateral cross-sectional view of the therapeutic device of  FIG.  4 A , taken along line C-C. 
         FIG.  4 D  is a longitudinal cross-sectional view of the therapeutic device of  FIG.  4 A , taken along line D-D. 
         FIG.  5 A  is a top plan view of a therapeutic device, in accordance with another embodiment of the present invention. 
         FIG.  5 B  is a bottom plan view of the therapeutic device of  FIG.  5 A . 
         FIG.  5 C  is a lateral cross-sectional view of the therapeutic device of  FIG.  5 A , taken along line C-C. 
         FIG.  5 D  is a longitudinal cross-sectional view of the therapeutic device of  FIG.  5 A , taken along line D-D. 
         FIG.  6    is a top plan view of the therapeutic devices of  FIGS.  4 A and  5 A , as applied to a forehead of a user. 
         FIG.  7    is a schematic diagram of a system implementing a method of manufacture in accordance with an embodiment of present invention. 
         FIG.  7 A  is a perspective view of a machine system for manufacturing and packaging the therapeutic device of  FIG.  2 A , in one stage of operation in accordance with an embodiment of the present invention. 
         FIG.  7 B  is a perspective view of the machine system of  FIG.  7 A  in another stage of operation in accordance with an embodiment of the present invention. 
         FIG.  8 A  is a perspective view of a therapeutic device, in accordance with another embodiment of the present invention. 
         FIG.  8 B  is a top plan view of the therapeutic device of  FIG.  8 A , in a neutral configuration. 
         FIG.  8 C  is a bottom plan view of the therapeutic device of  FIG.  8 A . 
         FIG.  8 D  is a cross-sectional view of the therapeutic device of  FIG.  8 B , taken along line D-D. 
         FIG.  8 E  is a cross-sectional view of the therapeutic device of  FIG.  8 A , in a depressed configuration, as applied to skin. 
         FIG.  8 F  is a cross-sectional view of the therapeutic device of  FIG.  8 A , in an adhesion configuration, as applied to skin. 
         FIG.  8 G  is a cross-sectional view of a therapeutic device, in accordance with another embodiment of the present invention. 
         FIG.  9    is a top plan view of the therapeutic device of  FIG.  8 A , as applied to a temple region of a user. 
         FIG.  10    is a schematic diagram of a system for implementing a method of manufacturing a therapeutic device in accordance with another embodiment of the present invention. 
         FIG.  11    is a perspective view of a therapeutic device in accordance with another embodiment of the present invention. 
         FIG.  12    is a perspective view of the devices of  FIGS.  11  and  14   , as applied to forearm of a user. 
         FIG.  13    is a perspective view of the device of  FIG.  11   , as applied to a thigh and a foot of a user. 
         FIG.  14    is a perspective view of a therapeutic device in accordance with another embodiment of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The present invention is directed to a device having a bridge portion adapted for releasable adherence to a patch of skin so as to lift the patch of skin above a sensitive underlying treatment site in reducing discomfort or pain associated with tissue compression at the treatment site. The device is positioned on the patient such that the bridge portion is elevated above the treatment site in a direction generally perpendicular to the patch of skin with an exposed adhesive facing the patch of skin to be lifted and/or stretched outwardly. With the application of pressure to elastically deform the device from its original neutral configuration, the bridge portion is brought into contact with the patch of skin, adhering the skin to the adhesive. When the pressure is removed, the device rebounds and generally reassumes its original configuration with the bridge portion lifting the attached patch of skin as it returns to an elevation at or near its original elevation. 
     With reference to  FIGS.  2 A- 2 D , a device  200  has a thin sheet body  202  with a longer length dimension L and a shorter width dimension W. The body  202  has an outer surface  204  and an inner (skin-contacting or skin-facing) surface  206 . The body  202  may be constructed of any suitable material with “memory” such that the body can be deformed under application of a force or load from an original shape or configuration and elastically return to the original shape or configuration after removal of the force or load. Depending on the underlying material of which the body  202  is constructed, the body  202  may have a thickness T ranging between about 0.012 and 0.018 inches (0.30 mm-0.45 mm), and preferably about 0.015 inches (0.40 mm). The body  202  may also be provided with one or more predetermined curvatures C, such as concavity or convexity, in one or both axes L and W. 
     Suitable materials for the body  102  include materials that are biocompatible or FDA-approved plastics, acrylate, polymers, metal, such as aluminum or stainless steel, or even wood or wood composites. A presently preferred material is polyethylene terephthalate (PET). 
     For use of the device  200  to treat the symptoms of CTS, the thin sheet body  202  of the device has a “butterfly” configuration adapted affixation to a palm  113  of a user, as illustrated in  FIG.  3   . The body  202  of the device  200  has two larger side support portions or “wings”  120  and an elevated bridge portion  208  extending between the support portions  120 . The body  202  spans between about 1½ inches and 1¾ inches (about 3.81 cm and 0.69 cm), and preferably about 1¼ inches (about 0.49 cm) in the direction of the shorter/width dimension or axis W, and about 2½ inches and 2¾ inches (about 0.98 cm and 1.08 cm), and preferably about 2¼ inches (about 0.89 cm) in the direction of the longer/length dimension or axis L. 
     In other embodiments, the body  202  has a thickness T ranging between about 0.012 and 0.016 inches (about 0.030 cm and 0.040 cm), and spans between about 1 inch and 1⅓ inches (about 0.0047 cm and 0.0063 cm), and preferably about 1⅕ (1.235) inches (about 0.486 cm) in the direction of the shorter/width dimension or axis W, and about 1⅘ inches and 2.0 inches (about 0.71 cm and 0.79 cm), and preferably 1 9/10 (1.900) inches (about 0.75 cm) in the direction of the longer/length dimension or axis L. 
     The bridge portion  208  is rectangular, being elongated along the axis W and spanning about ⅜ inch (about 0.15 cm) in the L axis. Each of the side portions  220  has a rounded “petal” shape with a greater outer width  221  that tapers slightly to a lesser inner width  122  adjacent the body  208 . 
     Moreover, the body  202  is provided with at least one predetermined curvature relative to an axis to conform to contours of the palm  113  near the wrist and location of the carpal tunnel ( FIG.  1   ). In the illustrated embodiment of  FIGS.  2 C and  3   , the body  202  has a predetermined concavity in the axis W toward the inner surface  206  to correspond with the convexity at the proximal end of the palm  113  ( FIG.  1   ). The predetermined concavity of the body relative to the axis W may generally trace a circle defined by a radius R ranging between about 4 to 6 inch diameter (about 1.57 cm to about 2.36 cm, preferably about a 5 inch diameter (about 1.97 cm). 
     The inner surface  206  of the bridge portion  208  is provided with an adhesion member or adhesive  226 , for example, a coating or layer of adhesive for releasably affixing the device  200  to the palm. The adhesive  226  is covered and protected by a release liner  228  that is removed prior to use of the device  200  and application onto the user&#39;s skin. 
     With reference to  FIGS.  3  and  3 A- 3 C , use of the device  200  is described as follows. After the release liner  228  has been removed to expose the adhesive  226 , the device  200  is placed over the palm  113  with the inner surface  106  and the adhesive  226  facing the palm  113 . The device  200  is oriented with its longer axis L being generally transverse to middle finger  114 . As shown in  FIG.  3 A , the device is positioned with each wing portion  220  resting on a respective convexity of the palm near muscles  102  and  104 . With the device in its original and neutral configuration, the bridge portion  208  spans linearly in between the muscles  102  and  104 , and elevated from the recess  112  and the median nerve  118 . Advantageously, the slight but predetermined concavity of the device  100  in the lateral or W axis ( FIG.  2 C ) enables the device to conform to the convexity of the palm  113 , with the bridge portion  108  being elevated and separated from the skin below by an air gap G. As shown in  FIG.  3 B , to apply the device, pressure P is then applied, for example, by the user&#39;s other hand or that of an assistant, to the outer surface  204  of the bridge portion  208  above the adhesive  226  toward the skin so as to deform the bridge portion  208  (and any other portions of the body  202 ), bring the adhesive  226  into contact with the skin and allow the adhesive  226  to adhere to the skin, reducing or eliminating the air gap G. 
     When the pressure P is removed and the body  202  is released, the elastically deformable body  202  generally returns to its original neutral state in reassuming the predetermined concavity and the linearity between the bridge portion  208  and the wing portions  220 , with at least a portion of the skin of the recess  112  adhering to the adhesive  226 , as shown in  FIG.  3 C . Advantageously, the linearity or “bridging” of the bridge portion  208  when the body  202  rebounds pulls the adhered skin and adjacent tissue in the region of the recess  112  outwardly or away from the median nerve  118  to result in negative pressure and reduction of compression of the median nerve. In accordance with a feature of the invention, the lifted skin or tissue may be raised or repositioned from its original position a distance ranging between 1.0 mm to 5 mm, preferably 2.0 mm to 4.0 mm, and more preferably about 3.0 mm. To that end, the concavity of the body  202  which extends across the bridge portion  208  further strengthens the bridge portion  208  when lifting the skin against the pull of adjacent skin. Moreover, opposing ends  208 E of the portion  208 , each with three sides unattached to the body  102 , allow the device  200  to be more flexible and comfortable while affixed to the palm, while providing additional bridging strength to the bridge portion  208  against the pull of adjacent skin, as well as providing additional surface area for the adhesive  226  to adhere with the skin. 
     In the disclosed embodiment, the bridge portion  208  is adhered to the skin, whereas the wing portions  220  are without adhesive and are not attached but are free to move and slide relative to the skin. This freedom of movement increases comfort to the user of the device by minimizing pinching or poking that may otherwise resulting discomfort if the wing portions (or any portions thereof) were also adhered to the skin. In that regard, a layer of fabric or liner or a coating of friction reducing gel may be provided on the inner surface of the wing portions  220  to prevent chafing. However, it is understood that the adhesive and adhesion member may be applied to one or more regions on the inner surface of the body and configured to cover beyond the bridge portion, for example, all or portion(s) of each or both wing portions  220 . 
     It is understood that the bridge portion  208  need not be centered between the wing portions  220 . That is, the size and/or shape of each wing portion  220  need not be equal or matching to the other. One wing may be larger, wider and/or longer than the other, as need or appropriate. There need not be symmetry about the axis L or W. 
     In an alternative embodiment of the present invention, a device  300  to treat the symptoms of a migraine headache is illustrated in  FIGS.  4 A- 4 D . Similarities between the devices  200  and  300  (as well as other devices described herein) are denoted by similar reference numerals. However, each device has different adaptations for application and affixation to the patient&#39;s body. For example, the device  300  has adaptations for application and affixation to a generally flat skin site such as forehead  130  ( FIG.  6   ), although it is understood that the device  200  may also be used to treat migraine headaches. A body  302  of the device  300  has a generally rectangular configuration with rounded corner  340 , and a bridge portion  308  contiguous with two opposing rectangular or square side support portions  320 . The body  302  spans between about ¾ inches and 1¼ inches (about 0.30 cm and 0.49 cm), and preferably about 1.0 inches (about 0.39 cm) in the direction of the shorter/width dimension or axis W, and about 2.0 inches and 2½ inches (0.79 about cm and 0.98 cm), and preferably about 2¼ inches (about 0.89 cm) in the direction of the longer/length dimension or axis L. The bridge portion  308  is rectangular, being elongated relative to the axis W and spanning about ⅜ inch (about 0.15 cm′ in the L axis. 
     The body  302  has at least two predetermined curvatures (same or different degree of curvatures), one in the axis W ( FIG.  4 C ) and another in the axis L ( FIG.  4 D ), to provide concavity toward the inner surface  304  in at least two directions. 
     In another embodiment of the present invention for treatment of migraine symptoms, especially in the center of the forehead above the nose as illustrated in  FIG.  6   , a similar device  300 ′ of  FIGS.  5 A- 5 D  may have one or more arcuate longitudinal edges  342  which can accommodate placement of the device around eyes, nose or ears. 
     For either device  300  or  300 ′, inner surface  206  of the bridge portion  208  is provided with adhesion member or adhesive, which may include one or more suction cups  330  ( FIGS.  4 A- 4 D ) or micro suction cup tape  332  ( FIGS.  5 A- 5 D ) having a surface with a multitude of microscopic craters  334  that work by creating many partial vacuums between the tape and target surface. The tape  332  can rebond repeatedly, and leaves no residue on the skin. A preferred tape is No. MSX-6800, DC Conformable Hi-Tack Type tape manufactured by 3M. 
     Moreover, for either device  300  or  300 ′, on the inner surface  306  at or near lateral edges  344 , each side support portion  320  includes a projection, such as a raised ridge  346  with a height H ( FIGS.  5 A- 5 B ) which elevates the body  302  away from the skin so that the bridge portion  308  forms a bridge that is separated from the skin with an air gap in between. In that regard, the body  302  has sufficient rigidity to provide linearity between the portions  308  and  320 . Each ridge  346  may have a different height, depending on the contour of the site. The ridges  346  may be constructed of the same material as the body  302  or of any other suitable material that provides sufficient form and structure to lift the body  302 . Where the body  302  spans about 1 7/16 inches (about 0.81 cm) along the axis L, and about 1 3/16 inches (about 3.02 cm) along the axis W, each ridge  346  may have a thickness of about 3/16 inch (0.48 about cm) and a width ranging between about ⅛ inch and ¼ inch (about 0.32 cm and 0.64 cm). Ends of each ridge may terminate a distance of about ⅛ inch (about 0.32 cm) from the longitudinal edges  240 . 
     It is noted that the concavity/ies of the bodies (actual or as effectuated by the ridges  346 ) should be of a sufficient degree such that peripheral edges, including longitudinal edges  340  and lateral edges  344  extend beyond the adhesive (e.g., adhesive coating, adhesive tape, suction cups, or micro-suction cup tape) so as to elevate the adhesive from skin and provide an initial air gap before the skin is adhered to the device (as shown in  FIGS.  4 C,  4 D and  5 D ). 
     In use, the adhesive  326  is exposed and the device  300 ′ is placed over the target skin site with the inner surface  306  and the adhesive  326  facing the skin. The device  300  is oriented with the ridges  346  straddling the skin site so that the bridge portion  308  and the adhesive  326  is directly over the sensitive skin site. Elevated by the ridges  346 , the bridge portion  308  is situated above the skin, separated by an air gap. With the device so positioned, pressure is then applied by the user (or an assistant) to the outer surface  304  of the bridge portion  208  directly above the adhesive  326  toward the skin so as to deform the bridge portion  308  (and any other portions of the body  302 ), bring it into contact with the skin and allow the adhesive  326  to adhere to the skin. 
     When the pressure is removed and the body  302  is released, the elastically deformable body  302  generally returns to its original neutral state in reassuming the linearity between the bridge portion  308  and the side portions  320 , thereby lifting the adhered skin and tissue and reducing compression at the site. The device can be situated around the eyes, near a temple, or above the nose on the forehead, as facilitated by the arcuate longitudinal edges  240 , as shown in  FIG.  6   . 
     With reference to  FIG.  7   , the foregoing devices may be manufactured in accordance with the following method: 
     1. Providing a single flat sheet  150  of suitable material; 
     2. Heating the sheet to smooth the sheet  150  and remove wrinkles and bends; 
     3. Stamping, die-cutting or otherwise cutting the sheet  150  to form the device. 
     4. Applying the adhesive to the inner surface of the bridge portion. 
     The method may include forming the sheet  270  with at least one predetermined curvature. 
     Heating the sheet may include passing the sheet  170  through a heat tunnel  151 , and/or under or between heated roller(s)  152 . Forming the sheet  150  with at least one predetermined curvature may include passing the sheet through heated roller(s)  154 . Stamping, die-cutting or otherwise cutting the sheet into device bodies may be performed by a die set including roller  154  and a movable punch  156 . The movable punch  156  may be curved to conform to the curvature of the roller  154  to simultaneously form the device body with at least one or more predetermined curvature. Applying the adhesive  326  may occur at any stage, including before, during or after stamping, die-cutting or otherwise cutting the sheet. As mentioned, the adhesive may be medical grade adhesive suitable for topical use. It may take the form of a solid coating or layer (or a plurality of adhesive lines), double-sided adhesive tape, suction cup(s) or micro-suction cup tape. Any release liner may be applied simultaneously with the application of the adhesive or afterwards. 
     Where the device has ridges  246 , the die set may have formations to stamp the ridges into the sheet, or they may be mounted after stamping. Alternatively, the method of manufacture may include applying or adhering the ridges  246  to the inner surface of the bridge portion before, during or after application of the adhesive to the inner surface. 
     An embodiment of a machine system  160  implementing a method of manufacture and packaging of the device is illustrated in  FIGS.  7 A and  7 B . The machine system  160  includes a longitudinal conveying platform  161  that defines a conveying pathway P from a first end  162  downstream to a second end  164 . At or near the first end  162  is dispenser roller  166  of sheet material  167 . Stored in roll form, the sheet material advantageously has a preformed curvature. To that end, the dispenser roller  166  in one embodiment of the invention has an initial diameter no greater than about 25 inches and more preferably no greater than about 20 inches. 
     Downstream of the dispenser roller  166  is a smooth roller  168  positioned to flatten the sheet material and remove wrinkles or bumps. Downstream of the smooth roller  168  is an adhesive tape applicator roller  172  which applies double-sided adhesive tape strips  174  onto an upward surface  175  of the sheet material (which becomes the inner/skin-facing surface of the device). The tape strips  174  are mounted on the applicator roller  172  with an exposed adhesive surface  171  facing outwardly so that it contacts and affixes to the upward surface  175  of the sheet material  167  upon pressure applied by the roller  172 . Release liner strips  173  are affixed to the opposing surface of the applied tape strips  174  for subsequent removal by users when applying the devices. 
     Downstream of the applicator roller  172  is a die press  179  with upper platen  176  and lower platens  178 A and  178 B driven by air hydraulics assembly  180 . The upper platen  176  is driven toward first lower platen  178 A in a first stage operation of the die press and toward the second lower platen  178 B in a second stage operation of the die press, as described below, to die cut a plurality of individual devices  10 A and  10 B from the sheet material  167  and the tape strips  174  affixed thereon. 
     The lower platens  178 A and  178 B are supported on a carrier  182  that is adapted for translational movement in opposition directions T 1  and T 2  along a pathway generally transverse to the conveying pathway P. In a first stage operation ( FIG.  7 A ), the carrier  182  slides in direction T 1  to position the first lower platen  178 A directly below the upper platen  176  wherein the upper platen  176  engages the first lower platen  178 A and cuts devices  10 A in die recesses  181 A, exposing the second lower platen  178 B off one side of the conveying platform  161  and rendering it accessible to a transport member  184 B. In the second stage ( FIG.  7 B ), the carrier  182  slides in direction T 2  to position the second lower platen  178 B directly below the upper platen  176 , wherein the upper platen  176  engages the second lower platen  178 B and cuts devices  10 B in die recesses  181 B, exposing the first lower platen  178 A off the opposite side of the conveying platform  161  and rendering it accessible to an opposing transport member  184 A. Accordingly, the carrier  182  translates each lower platen  178 A and  178 B between an engagement position under the upper platen  176  and an unload position under respective a transport member  184 A. Where a full die cut cycle of the die press involves the first stage operation followed by the second stage operation in sequence, the hydraulics assembly drives the die press  179  and carrier  182  in a manner whereby one of the lower platen is placed under the upper platen  176  for die cutting and while the other lower platen is exposed and accessible to a respective transport member  184 . That is, in one stage of operation, the one lower platen is in the engagement position whereas the other lower platen is in the unload position, and in the other stage of operation, the other lower platen is in the engagement position whereas the one lower platen is in the unload position. 
     In addition to driving the die press  179  and the carrier  182 , the hydraulics assembly  180  also drives support arms  185  to move the transport members  184 A and  184 B between at least three positions: a wait position, a load position, and an off-load position. The transport members are adapted to secure a load of devices and transport the devices from the lower platens  178 A and  178 B to packaging or dispensers  183  arranged on tray members  186 A and  186 B arranged below the lower platens in their exposed positions. As shown in  FIG.  7 A , when lower platen  178 B is exposed and accessible to transport member  184 B, the transport member  184  is actuated by the hydraulics assembly  180  to move from its wait position to the load position where it picks up devices  10 B from the lower platen  178 B. In the illustrated embodiment, the transport member  184  includes grippers with vacuum/suction cups  189  mounted on posts  190  which are activated to grab the devices  10 B individually. With a load of devices on board, the transport member  184 B is actuated by the hydraulics assembly  180  to move into the off-load position toward the tray member  186 B positioned below the exposed position of the lower platen  176 B and release the devices  10 B into dispensers  183 B. The transport member  184 B is then returned to its wait position for the next cycle when the lower platen  176 B contains more cut devices and is exposed and accessible again. 
     The tray member  186 B is supported on carrier  188 B which translates the tray member  186 B along direction C parallel with the conveying pathway P so that the tray member  186 B can shift between different positions for efficient loading of the dispensers  184 . In the illustrated embodiment, the tray member is translated between two positions: a proximal position and a distal position. 
     It is understood that the actuation and movement of the die press  179 , the carrier  182 , the transport members  184 A and  184 B and the carriers  188  may be coordinated and synchronized with each other, as desired or appropriate for efficient operation of the machine system. For example, the upper platen  176  may be driven to engage lower platen  178 A as the support arm  185 B is driven to pick up devices  10 B from the lower platen  178 B, and as the support arm  185 A is releasing devices into the dispensers  181 A. A suitable system and machine for transporting work pieces is described in U.S. Pat. No. 8,230,989, entitled SHUTTLE MACHINE FOR MACHINE TOOL, the entire contents of which are hereby incorporated by reference. 
     The spent sheet material  167  downstream of the die press  179  is drawn downstream by a servo drive rollers  190  and collected on a waste roller  192  at the second end  164  of the conveying platform  161 . 
     Another embodiment of the present invention is illustrated in  FIGS.  8 A- 8 C . A device  400  has a thin sheet body  402  which has been formed with a raised center profile. The body  402  has a support portion  402  and an elevated planar center bridge portion  408 . The support portion  402  is adapted to rest on skin above a sensitive underlying site, such as temple  132 , as shown in  FIG.  9   . The support portion  402  includes an outer rim or base  450  and radially extending L-shaped legs or posts  454  projecting therefrom that connect the base  450  and the bridge portion  408 . The base  450  is adapted to rest on and generally surround skin of a sensitive underlying site, such as temple  132 , as shown in  FIG.  9   . Between adjacent pairs of legs is an opening  456 . As better seen in  FIGS.  8 D- 8 F , each leg has a radial portion  460  coplanar with the bridge portion  408  and an axial portion  462  extending between the radial portion and the base  450 . The axial portion  462  may extend at an angle ranging between about 45 to 120 degrees, preferably about 60 to 100 degrees, and more preferably about 90 degrees, from the base  450 . The plurality of legs  454  ranges between about two and five. 
     With reference to  FIGS.  8 A- 8 F , the illustrated embodiment of the device has three legs  454  positioned equidistance from each other (e.g., centered at about 0, 120 and 240 degrees), and three openings  456 . Moreover, each leg presents a 90 degree angle between the radial portion  460  and the axial portion  462 , and also between the axial portion  462  and the base  450 . Width of the legs can vary depending on the plurality of legs and the desired flexibility of the bridge portion  408 . An inner surface  406  of the bridge portion  408  has an adhesion member or adhesive  426 , for example, a coating or layer of adhesive, an adhesive tape or a micro suction cup tape, as described above. An inner surface of the rim  450  may also be provided with an adhesion member or adhesive to help secure the device on the skin. 
     In one embodiment, the outer radius r of the base  450  is 1.375 inches (about 3.50 cm), the radius R of the bridge portion  408  is 0.5 inch (about 1.27 cm), the width WA of the axial portion  462  is 0.625 inch (about 1.59 cm), and the width WB of the base  450  is 0.125 inch (about 0.32 cm). The height H of the bridge portion  408  from the base  450  is 0.1875 inch (about 0.48 cm) and the thickness of the body  402  throughout the device  10  is 0.015 inch (about 0.038 cm). 
     The base  450  and the bridge portion  408  may each be any shape, for example, rectangular, polygonal, oval, or circular. In the illustrated embodiment, both the base and the bridge portion are circular. 
     In use, the adhesive  426  is exposed and the device  400  is placed over the target skin site with the base generally surrounding the site and the adhesive  426  facing the skin and tissue, as shown in  FIG.  8 D . Elevated by the legs  454 , the bridge portion  408  is situated above the skin, separated by an air gap generally equal to the height H. With the device so positioned, pressure P is applied by the user (or an assistant) to the outer surface  404  of the bridge portion  408  toward the skin so as to deform the upper body  452  (including the bridge portion  408  and/or any of the legs  454 ), bring the bridge portion  408  into contact with the skin and allow the adhesive  426  to adhere to the skin, as shown in  FIG.  8 E . 
     When the pressure is removed and the upper body  452  is released, the elastically deformable body  402  rebounds and generally returns to an elevation at or near its original elevation wherein the bridge portion  408  lifts the adhered skin and tissue and reducing compression at the site. 
     As shown in  FIG.  8 D , the bridge portion  408  and the radial leg portion  460  may extend perpendicularly relative to the axial leg portion  462 , or the portions  408  and  460  may have at least one predetermined curvature in a direction. As illustrated in  FIG.  8 F , device  400 ′ has an upper body  462 ′ with curvature in more than on axial direction to provide a concavity toward the inner surface  406  that forms an elevated dome. 
     The devices of the present invention may be worn at all times, or only a specified time periods, such as night time, during sleep. Each device may be reused so long as the adhesive is functional. If not, the device may be discarded, or new adhesive may be applied to the device over or in place of the spent adhesive. Due to the inexpensive cost of the device and its components, the device may be economically discarded as trash or for recycling. 
     With reference to  FIG.  10   , the device  400  can be manufactured as follows: 
     1. Forming the device;
         (a) Injection, press or vacuum forming the base  450 , bridge portion  408  and the legs  454 ; or   (b) Providing a single flat sheet  470  of suitable material;
           (i) Heating the sheet to smooth the sheet  370  and remove wrinkles or bends;
               1. Heating by passing through a heat tunnel  471 ; and/or   2. Heating by heated roller(s)  472 .   
               (ii) Stamping, die-cutting or otherwise cutting sheet to form the base  450 , the bridge portion  408  and the legs  454 ;
               1. Die punching out the openings  456  to form the legs with die set  473 ;   
               
               

     2. Applying the adhesive  426  to the inner surface  406  of the bridge portion  408 . 
     The stamping, die-cutting or otherwise cutting of the sheet may include both cutting of the base  450 , bridge portion  408  and legs  454  from the sheet and reforming/reshaping to provide the curvature of the upper body  452  and/or angulation or bend in the leg  454  for elevating the bridge portion  408  from the base  450 . The application of the adhesive  426  may occur before, during or after stamping, die-cutting or otherwise cutting of the sheet. 
     In yet another embodiment of the present invention, a device  500  may be worn as a band or sleeve encircling a limb or a portion thereof. With reference to  FIG.  10   , the device  500  is elongated defining a length axis L and a width axis W. The device  500  has a generally rigid yet flexible main body  511  having a planar, generally rectangular form, and two fastening side portions  513 , each having a generally rectangular form and adjoined to an opposing side edge  515  of the main body  511 . The main body  511  may be constructed of the same aforementioned suitable materials. The side portion  513  may be constructed of an elastic, stretchable material or fabric. On an inner surface  506  of the main body  511 , an adhesion member  526  is provided and situated between at least two projections  546  defining an elevated bridge portion  508 . 
     In use, the device  500  is positioned on a limb, for example, a forearm ( FIG.  12   ), a thigh or a foot ( FIG.  13   ), with the exposed adhesion member  526  and projections  546  facing the skin above the treatment site. The side portions  513  are wrapped around the limb and releasably fastened to each other by fasteners  517 , e.g., hook and loop fasteners, eye and hook fasteners, snap fasteners, etc. The device  500  in a neutral configuration presents the bridge portion  508  at an elevated position above the skin, the two separated by an air gap. When pressure is applied to outer surface  504  of the bridge portion  508 , the device assumes a deformed configuration so that the adhesion member comes  526  into contact with the skin. When the pressure is removed, the device rebounds and the skin is lifted by the bridge portion. The device  500  may have a slight predetermined curvature or concavity in the L axis toward the inner surface  506  to better conform to the limb. 
     In a further embodiment of the present invention, a device  500 ′ may be worn as a cuff on the wrist, as shown in  FIG.  12   . The device  500 ′, as illustrated in  FIG.  11   , has a construction similar to that of the device  500  of  FIG.  10   , except that the device is smaller and has a pronounced predetermined curvature or concavity in the L axis toward the inner surface  506  to better conform to the wrist. 
     The present invention also includes a method of manufacturing a custom-fitted therapeutic device, wherein a mold of the treatment site, e.g., a palm, a forearm, a thigh, is made and a die set for manufacturing the device is customized according to the mold. 
     The preceding description has been presented with reference to presently preferred embodiments of the invention. Workers skilled in the art and technology to which this invention pertains will appreciate that alterations and changes in the described structure may be practiced without meaningfully departing from the principal, spirit and scope of this invention. As understood by one of ordinary skill in the art, the drawings are not necessarily to scale. Dimensions of the devices may be modified to fit different sized users. As noted above, the device may have more than one adhesive or adhesive member which may be applied to different areas of the device beyond the bridge portion. Accordingly, the foregoing description should not be read as pertaining only to the precise structures described and illustrated in the accompanying drawings, but rather should be read consistent with and as support to the following claims which are to have their fullest and fair scope.