HK1227687B - Therapeutic skin lifting device and related systems and methods - Google Patents

Description

Therapeutic skin lifting devices and related systems and methods

This application is a divisional application. The application date of the original application is February 27, 2013, the application number is 201380022871.7 (PCT/US2013/028099), and the name of the invention is “Therapeutic skin lifting device and related systems and methods”.

Field of the Invention

The present invention relates to a medical device for reducing symptoms of physical diseases and conditions, including pain and discomfort associated with carpal tunnel syndrome (CTS), migraines, and other stress-related diseases and conditions.

background

Carpal tunnel syndrome (CTS) is an idiopathic median neuropathy that occurs in the human wrist. Referring to FIG1 , the muscles underlying the thumb 106 and pinky finger 108 of a human hand 100 are shown, including the abductor pollicis brevis 102 and the abductor digiti minimi 104, respectively. Muscles 102 and 104 define a transverse carpal arch 110 with a recess 112 between them that typically aligns with the third finger 114. The tissue underlying recess 102 is the carpal tunnel 116, where the median nerve 118 enters the hand 100. This tunnel is typically narrow because it is also occupied by the flexor tendons 120, so any swelling of the adjacent tissues, including the flexor retinaculum ligament 122, can pinch the nerve and cause pain, numbness, tingling, or weakness.

The pathology of CTS is not fully understood, but it is believed to be compression of the median nerve, which passes through the carpal tunnel. Many studies have been conducted to identify the cause, but the evidence is unclear. Various results published in the 1990s found a strong correlation between the prevalence of CTS and forceful and repetitive wrist movements, such as working on a keyboard and computer. However, more recent studies have cited genetics and obesity as potentially greater factors than use and have promoted attention in attributing causality.

Pregnant women, especially those in their third trimester, may experience hand pain and discomfort, such as numbness, tingling, or pain in the hands and wrists, particularly at night when fluids are more equally distributed throughout the body rather than just in the lower extremities. Because pregnancy causes swelling in many parts of the body, extra pressure can be placed on the nerves in the hands and wrists, including the median nerve.

The only scientifically 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 patients showed a recurrence of painful symptoms. Moreover, surgery carries many risks and is not suitable for temporary CTS, such as experienced by pregnant women. Palliative treatment for CTS includes the use of night splints and corticosteroid injections. Other non-surgical treatments include hand braces, exercises, ergonomic devices, oral diuretics, and nonsteroidal anti-inflammatory drugs (NSAIDs). Websites including www.mycarpaltunnel.com discuss different treatment options. Other methods include gloves, as described in U.S. Patent No. 6,006,751 and the prior art cited therein. Obviously, such gloves can be relatively expensive and are not disposable. Gloves can also limit manual dexterity and tactile sensitivity.

Exercise tape has also been used as a non-surgical treatment for CTS. Conventional exercise tape is made of highly elastic cord wrapped in cotton fibers. It is used as a light stretch therapy for soft tissue disorders and repetitive strain injuries. The exercise tape has an elasticity that is expected to match a person's skin, muscle, cartilage, and connective fascia tissue. However, there are many different methods and techniques for taping around the hand and wrist, and improper taping can cause additional discomfort or even additional damage to the median nerve. Moreover, if the patient cannot apply the tape without assistance, proper taping often requires the use of two hands, which makes it difficult.

Hand braces and splints, as well as temporary, removable devices worn on the hand, are also known, such as the distraction hand device described in U.S. Patent No. 6,315,748 and sold under the trademark THE CARPAL SOLUTION. The device includes a central, resilient, distractible tensioning segment with a plurality of relatively less distractible adhesive straps secured to the segment. In use, the segment is placed on the back of the patient's hand, and the straps are pulled over it in an extended segment manner and attached to the patient's palm. In this orientation, the control segment exerts a continuous yield force or tension through the straps, which in turn reduces nerve compression and alleviates symptoms of carpal tunnel syndrome.

Another serious condition that a significant portion of the population suffers from is migraine. Migraine pain occurs when irritated brain cells trigger the trigeminal nerve to release chemicals that irritate and cause blood vessels on the surface of the brain to swell. These swollen blood vessels send pain signals to the brainstem, the area of the brain that processes pain information. Migraine pain is referred pain, often felt around the eyes or temples.

In addition to prescription and over-the-counter medications, there are many migraine relief methods, including sleep, caffeine, ice packs, and avoiding sunlight or certain foods. Exercise bands have also been used to relieve severe headaches. Experts believe that banding can significantly help reduce headaches by repositioning stressed muscles and thus helping to relieve tension in the neck.

Adhesive tape or strips have numerous medical uses and applications beyond wound dressing. For example, snoring strips are sheets of elastic plastic embedded in a plaster for attachment across the outside of the nose. Shape memory causes the plastic to straighten, effectively widening the nasal passages to allow for improved airflow. These strips are disposable and simplified in design, construction, and use.

Therefore, there is a desire for a device that can reduce the symptoms of stress-related conditions and diseases, including CTS and migraines. There is also a desire for a device that is simple in design, construction, and use and that can lift the skin over potentially sensitive areas.

SUMMARY OF THE INVENTION

The device of the present invention is primarily intended for those suffering from carpal tunnel syndrome (CTS), but also has application in alleviating migraines and other conditions where lifting skin and tissue over potentially sensitive areas would provide benefit.

The present invention provides an inexpensive, reliable and easy-to-use device that lifts an area of skin upward in a direction generally perpendicular to the skin surface. It does not interfere with the user's sleep and is a low-cost disposable product. In a preferred embodiment, for CTS, the device comprises a thin, generally rectangular component having a long dimension and a short dimension. The component is made of plastic and has "shape memory" and its normal configuration is generally flat. When pressure is applied perpendicularly to the component, the component deforms. When released from the pressure, the "shape memory" component is elastic and bounces back to its normal configuration as much as possible. On the bottom (towards the skin) surface of the device, an adhesive or attachment component (used interchangeably herein) is provided on at least a portion of the central portion. A removable protective cover (e.g., a release liner made of wax paper) is applied to the adhesive.

During use, the protective cover is removed and the adhesive is applied to the palm near the wrist by pressing the center of the component toward the palm, securing the center of the component to the palm. The component is oriented so that its long dimension spans the palm between the thumb and pinky finger. Because the adhesive is applied to the concave portion of the palm, the device forms a bridge across the palm. The side portions of the component supporting the center are not attached to the palm, allowing them to slide freely in contact with the palm. When the component is peeled off and rebounds using its "shape memory," the negative pressure pulls the skin of the palm, which was adhered to the component's adhesive, upward.

The adhesive can be applied to the device by any conventional method so that when the protective backing is removed, the adhesive remains on the component. Alternatively, the adhesive can be applied directly to the component by the user or to the user's palm or skin. Lifting and/or stretching the skin in the palm or treatment area can alleviate symptoms, including those of CTS.

While the preferred embodiment contemplates the use of a single piece of spring type plastic, other designs may be incorporated to provide a resilient or shape memory component such as synthetic whalebone, polyester boning material, metal, metal alloys such as Nitinol, etc.

Thus, the present invention relates to a therapeutic device adapted for application to skin overlying a treatment site on a patient's body, comprising a generally rigid but resiliently deformable body having at least one support portion and a bridge portion, the support portion being adapted to be placed on the skin, the bridge portion having an adhesive that adheres to at least a portion of the skin, wherein the body is adapted to adopt a neutral configuration in which the adhesive and the skin portion are separated by a void, and an adhered configuration in which the skin portion adheres to the adhesive that is lifted and/or stretched at the treatment site. The body is further adapted to adopt a stressed configuration in which the body is deformed from the neutral configuration and the bridge portion is pressed to bring the adhesive into contact with the skin portion.

When in its neutral configuration, the body supports the bridge portion at a maximum height relative to the skin surface of the treatment area, and when in its compressed configuration, the body supports the bridge portion at a minimum height. Furthermore, when in its adhesive configuration, the body supports the bridge portion at a height between greater than the minimum height and less than the maximum height. The adhesive provided on the inner skin-facing surface may include a coating or layer of adhesive material, double-sided tape, at least one suction cup, and/or micro-suction cup tape.

In a more detailed embodiment, the therapeutic device comprises a sheet body having a "butterfly" configuration, wherein the support portion supporting the bridge portion includes a lateral planar portion adapted to be placed on the skin. The butterfly configuration is well-suited for application to the palm of a patient's hand, with the device positioned on the palm and the bridge portion longitudinally aligned with the median nerve of the palm. The adhesive is adapted to adhere to the skin beneath the device and above the median nerve.

The sheet body can also be configured in a rectangular shape with rounded corners and one or more curved sides. In this way, the device is also suitable for application to other areas of the patient's body. The rounded corners are atraumatic, and the curved side(s) conform to the features, curves, and contours of the face or body, such as the nose, eyes, knuckles, elbows, knees, and ankles.

In another more detailed embodiment, the treatment device has a body formed of a thin sheet having an outer peripheral edge and a raised central bridge portion. The edge and bridge portion can have a common shape, for example, a circle, a rectangle, a square, or a polygon. The bridge portion is supported by at least three legs extending upward from the edge. The formed body is well suited for application to the patient's forehead, for example, the temporal region. Each leg can 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 edge.

According to a feature of the invention, the body of the device may have one or more predetermined bends in one or more directions. When the device is in its normal or neutral configuration, the bend(s) are adapted to ensure that the bridge portion is raised and separated from the underlying skin by a gap. The bend(s) are also adapted to strengthen the bridge portion against the pull of the adhered skin when the device has been pressed and applied to the treatment site and allowed to rebound to or toward its neutral configuration under the shape memory of its body. In a more detailed embodiment, the bridge portion of the device has a bend or depression in at least one direction toward the interior, toward the surface of the skin.

The device can also be configured as a flexible belt or sleeve or semi-rigid cuff to be worn on an appendage. The body is adapted to be wrapped around or around an appendage, such as an arm or leg, and the inner, skin-facing surface has at least two protrusions or ridges with an adhesive located therebetween for adhering to the skin, wherein the skin is lifted when attached to the adhesive.

The present invention also includes a method and system for manufacturing the aforementioned therapeutic device. The manufacturing process includes:

1. Pass a sheet of plastic material through a heated tunnel to flatten or smooth the material.

2. Pass the material over rollers, such as silicone coated rollers, to bend the material to the desired radius.

3. Pass the material through an adhesive applicator, which applies adhesive, including tape with or without a release liner.

4. The material is passed through a cutting chamber, such as a set of dies, which cuts the body of the device from the material.

The order of the above steps may be changed if desired or appropriate.

The manufacturing method may further include customizing the therapeutic device by preparing a mold of the body portion that mates with the device and a set of dies to customize the mold.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other characteristics 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 should be understood that selected structures and features have not been shown in some of the drawings in order to provide a better view of the remaining structures and features.

1 is a perspective view of a hand with a cross-sectional view of the proximal portion including the median nerve and carpal tunnel.

2A is a top plan view of a therapeutic device, according to one embodiment of the present invention.

2B is a bottom plan view of the therapeutic device of FIG. 2A .

Figure 2C is a transverse cross-sectional view of the therapeutic device of Figure 2A taken along line C-C.

Figure 2D is a longitudinal cross-sectional view of the therapeutic device of Figure 2A taken along line D-D.

3 is a top plan view of the treatment device of FIG. 2A when applied to the palm of a user.

3A is a cross-sectional view of the therapeutic device of FIG. 2A in a neutral configuration.

3B is a cross-sectional view of the therapeutic device of FIG. 2A in a compressed configuration.

3C is a cross-sectional view of the therapeutic device of FIG. 2A in an adhered configuration.

4A is a top plan view of a therapeutic device according to another embodiment of the present invention.

4B is a bottom plan view of the therapeutic device of FIG. 4A .

Figure 4C is a transverse cross-sectional view of the therapeutic device of Figure 4A taken along line C-C.

Figure 4D is a longitudinal cross-sectional view of the therapeutic device of Figure 4A taken along line D-D.

5A is a top plan view of a therapeutic device according to another embodiment of the present invention.

5B is a bottom plan view of the therapeutic device of FIG. 5A .

Figure 5C is a transverse cross-sectional view of the therapeutic device of Figure 5A taken along line C-C.

Figure 5D is a longitudinal cross-sectional view of the therapeutic device of Figure 5A taken along line D-D.

6 is a top plan view of the treatment device of FIGS. 4A and 5A when applied to the forehead of a user.

FIG. 7 is a schematic diagram of a system for implementing a manufacturing method according to an embodiment of the present invention.

7A is a perspective view of a machine system for manufacturing and packaging the treatment device of FIG. 2A at one stage of operation in accordance with an embodiment of the present invention.

7B is a perspective view of the machine system of FIG. 7A at another stage of operation according to an embodiment of the present invention.

8A is a perspective view of a therapeutic device according to another embodiment of the present invention.

8B is a top plan view of the therapeutic device of FIG. 8A in a neutral configuration.

8C is a bottom plan view of the therapeutic device of FIG. 8A .

Figure 8D is a cross-sectional view of the therapeutic device of Figure 8B taken along line D-D.

8E is a cross-sectional view of the therapeutic device of FIG. 8A in a compressed configuration when applied to the skin.

8F is a cross-sectional view of the therapeutic device of FIG. 8A in an adhesive configuration when applied to the skin.

8G is a cross-sectional view of a therapeutic device according to another embodiment of the present invention.

9 is a top plan view of the therapeutic device of FIG. 8A when applied to the temporal region of a user.

10 is a schematic diagram of a system for implementing a method of manufacturing a therapeutic device according to another embodiment of the present invention.

11 is a perspective view of a therapeutic device according to another embodiment of the present invention.

12 is a perspective view of the device of FIGS. 11 and 14 as applied to a user's forearm.

13 is a perspective view of the device of FIG. 11 when applied to a user's thigh and foot.

14 is a perspective view of a therapeutic device according to another embodiment of the present invention.

Detailed Description of the Invention

The present invention relates to a device having a bridge portion that is adapted to be releasably attached to a skin patch to lift the skin patch over a sensitive underlying treatment site in order to reduce discomfort or pain associated with tissue compression at the treatment site. The device is placed on the patient so that the bridge portion is lifted over the treatment site in a direction generally perpendicular to the skin patch, with the exposed adhesive facing the skin patch to be lifted and/or stretched outward. As pressure is applied to elastically deform the device from its initial neutral configuration, the bridge portion begins to contact the skin patch, attaching the skin to the adhesive. When the pressure is removed, the device rebounds and generally assumes its original configuration again, with the bridge portion lifting the attached skin patch when it returns to a height at or near its initial height.

2A-2D , the device 200 comprises a sheet body 202 having a longer length dimension L and a shorter width dimension W. The body 202 comprises an outer surface 204 and an inner (skin-contacting or skin-facing) surface 206. The body 202 can be constructed of any suitable material having a "memory" such that the body can deform from an initial shape or configuration under the application of a force or load and elastically return to the initial shape or configuration after the force or load is removed. Depending on the underlying material comprising the body 202, the body 202 can have a thickness T ranging between approximately 0.012 and 0.018 inches (0.30 mm-0.45 mm) and preferably approximately 0.015 inches (0.40 mm). The body 202 can also be provided with one or more predetermined curvatures C, such as concave or convex, in one or both axes L and W.

Suitable materials for body 102 include biocompatible or FDA-approved plastics, acrylics, polymers, metals such as aluminum or stainless steel, or even wood or wood composites. A currently preferred material is polyethylene terephthalate (PET).

For use of the device 200 to treat CTS symptoms, the device's sheet body 202 has a "butterfly" configuration suitable for securing to a user's palm 113, as shown in FIG3 . 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 is between about _{1 1/2} ^inches and 1 _3/4 inches, and preferably about 1 ^1/4 inches, in the direction of the shorter/width dimension or axis W, and about 2 1/2 inches and 2 3/4 inches, and preferably about 2 ^1/4 inches, in the direction of the longer/ _length dimension or axis L.

The bridge portion 208 is rectangular, elongated along axis W and spanning approximately 3/8 inch at axis L. Each of the side portions 220 has a rounded "petal" shape, having a larger outer width 221 that tapers slightly to a thinner inner width 122 adjacent the body 208.

Furthermore, the body 202 is provided with at least one predetermined curvature relative to the axis to conform to the contours of the palm 113 proximal to the wrist and carpal tunnel ( FIG. 1 ). In the illustrated embodiment of FIG. 2C and FIG. 3 , the body 202 has a predetermined concavity in the axis W toward the inner surface 206 to correspond to the convexity proximal to the palm 113 ( FIG. 1 ). The predetermined concavity of the body relative to the axis W can generally trace a circle defined by a radius R having a diameter between about 4 and 6 inches, preferably about 5 inches.

The inner surface 206 of the bridge portion 208 is provided with an adhesive member or adhesive 226, for example, a coating or layer of adhesive, for releasably securing the device 200 to the palm of the hand. The adhesive 226 is covered and protected by a release liner 228, which is removed prior to use and application of the device 200 to the user's skin.

3 and 3A-3C , the 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 on the palm 113 with the inner surface 106 and the adhesive 226 facing the palm 113. The device 200 is oriented so that its longer axis L is generally transverse to the middle finger 114. As shown in FIG3A , the device is positioned so that each wing portion 220 is placed on the convex surface of the respective palm near the muscles 102 and 104. In its initial and neutral configuration, the bridge portion 208 spans linearly between the muscles 102 and 104 and rises from the recess 112 and the median nerve 118. Advantageously, the slight but predetermined concavity of the device 100 in its transverse or W axis ( FIG2C ) allows the device to conform to the convex surface of the palm 113, with the bridge portion 108 rising and separated from the underlying skin by a gap G. As shown in Figure 3B, to apply the device, pressure P is then applied, for example, by the user's other hand or an assistant's hand, to the outer surface 204 of the bridge portion 208 toward the skin over the adhesive 226 to deform the bridge portion 208 (and any other portion of the body 202), bringing the adhesive 226 into contact with the skin and allowing the adhesive 226 to adhere to the skin, reducing or eliminating the gap G.

When pressure P is removed and body 202 is peeled off, the elastically deformable body 202 generally returns to its initial neutral position, with at least a portion of the skin in recess 112 adhered to adhesive 226, as shown in FIG3C , after reasserting the pre-set concavity and linear orientation between bridge portion 208 and wing portions 220. Advantageously, the linear orientation or "bridging" of bridge portion 208 pulls the attached skin and adjacent tissue in the area of recess 112 outward or away from median nerve 118 as body 202 rebounds, resulting in reduced negative pressure and compression of the median nerve. According to features of the present invention, the lifted skin or tissue can be elevated or repositioned by a distance of between 1.0 mm and 5 mm, preferably between 2.0 mm and 4.0 mm, and more preferably approximately 3.0 mm, from its initial position. Furthermore, the concavity of body 202 extending across bridge portion 208 further reinforces bridge portion 208 when lifting the skin against the tension of the adjacent skin. Moreover, when secured to the palm of the hand, the opposing ends 208E of portion 208—each having three sides not connected to body 102—make device 200 more flexible and comfortable, while providing additional bridging strength to bridge portion 208 against pull forces against adjacent skin, and providing additional surface area for adhesive 226 to adhere to the skin.

In the disclosed embodiment, the bridge portion 208 is attached to the skin, while the wing portions 220 are free of adhesive and unattached, but move and slide freely relative to the skin. This freedom of movement increases the comfort of the device user by minimizing pinching or pricking, which could otherwise cause discomfort if the wing portions (or any portion thereof) were also attached to the skin. In this regard, a layer of fabric or lining or a friction-reducing gel coating can be provided on the inner surface of the wing portions 220 to prevent skin irritation. However, it should be understood that adhesive and cohesive components can be applied to one or more areas on the inner surface of the body and configured to cover more than the bridge portion, for example, all or part(s) of each or both wing portions 220.

It should be 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 match the other. One wing can be larger, wider, and/or longer than the other, as desired or appropriate. Symmetry about the L or W axes is not required.

In an alternative embodiment of the present invention, a device 300 for treating the symptoms of migraine headaches is shown in Figures 4A-4D. Similarities between devices 200 and 300 (as well as other devices described herein) are indicated by similar reference numerals. However, each device has a different adaptation for application and fixation to a patient's body. For example, device 300 is adapted for application and fixation to a generally flat skin site, such as forehead 130 (Figure 6), although it should be understood that device 200 can also be used to treat migraine headaches. The body 302 of device 300 has a generally rectangular configuration with rounded corners 340 and a bridge portion 308 adjacent to two opposing rectangular or square side support portions 320. The body 302 spans between approximately ¾ inch and 1-1/4 inches, and preferably approximately 1.0 inch, in the shorter/width dimension or axis W, and between approximately 2.0 inches and 2-1/2 inches, and preferably approximately 2-1/4 inches, in the longer/length dimension or axis L. The bridge portion 308 is rectangular, elongated about the W axis and spans about the L axis.

The body 302 has at least two predetermined curvatures (of equal or different degrees), one in axis W ( FIG. 4C ) and another in axis L ( FIG. 4D ), to provide concavity toward the inner surface 304 in at least two directions.

In another embodiment of the present invention for treating migraine symptoms, a device 300' similar to Figures 5A-5D may have one or more arcuate longitudinal edges 342 that can accommodate placement of the device around the eyes, nose, or ears, particularly in the center of the forehead above the nose as shown in Figure 6.

For device 300 or 300', the inner surface 206 of the bridge portion 208 is provided with an adhesive component or adhesive, which may include one or more suction cups 330 (Figures 4A-4D) or a micro-suction cup strip 332 (Figures 5A-5D), which has a surface with a plurality of tiny crescents 334 that function by creating a plurality of partial vacuums between the strip and the target surface. The strip 332 can reliably rebound and does not leave residue on the skin. A preferred strip is the 3M-made No. MSX-6800, DC Conformable Hi-Tack strip.

Furthermore, for device 300 or 300', each side support portion 320 includes a protrusion, such as a raised ridge 346 having a height H, on the inner surface 306 at or near the lateral edge 344 (Figures 5A-5B), which elevates the body 302 away from the skin so that the bridge portion 308 forms a bridge separated from the skin with a gap therebetween. From this point, the body 302 has sufficient rigidity to provide linearity between portions 308 and 320. Each ridge 346 can have a different height, depending on the contours of the site. The ridge 346 can be constructed of the same material as the body 302 or any other suitable material that provides sufficient form and structure to elevate the body 302. If the body 302 spans approximately 1-7/16 inches along axis L and approximately 1-3/16 inches along axis W, each ridge 346 can have a thickness of approximately 3/16 inches and a width ranging between approximately 1/8 inch and 1/4 inch. The end of each ridge may terminate approximately 1/8 inch from the longitudinal edge 240 .

It should be noted that the concavity/concavities of the body (actual or as caused by ridges 346) should be of sufficient degree so that the surrounding edges, including longitudinal edge 340 and transverse edge 344, extend beyond the adhesive (e.g., adhesive coating, tape, suction cup, or micro-suction cup tape) to raise the adhesive from the skin and provide a starting gap before the skin is attached to the device (as shown in Figures 4C, 4D, and 5D).

In use, the adhesive 326 is exposed and the device 300' is placed over the target skin site with the inner surface 306 and adhesive 326 facing the skin. The device 300 is oriented with the ridge 346 spanning the skin site so that the bridge portion 308 and adhesive 326 are directly over the sensitive skin site. By raising the ridge 346, the bridge portion 308 is positioned above the skin, separated by the 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 over the adhesive 326 and toward the skin, to deform the bridge portion 308 (and any other portion of the body 302), bringing it into contact with the skin and allowing the adhesive 326 to adhere to the skin.

When pressure is removed and the body 302 is peeled off, the elastically deformable body 302 generally returns to its original neutral state, wherein a linear position is again assumed between the bridge portion 308 and the side portions 320, thereby lifting the attached skin and tissue and reducing compression in that area. The device can be placed around the eyes, near the temples, or on the forehead above the nose, as facilitated by the arched longitudinal edges 240, as shown in FIG6 .

Referring to FIG7 , the above device can be manufactured according to the following method:

1. Provide a single flat sheet 150 of suitable material,

2. Heating the sheet to smooth the sheet 150 and remove wrinkles and bends;

3. Punch, die cut or otherwise cut sheet 150 to form the device.

4. Apply adhesive to the inner surface of the bridge portion.

The method may include forming sheet 270 having at least one predetermined curvature.

Heating the sheet 170 may include passing the sheet 170 through a heat tunnel 151 and/or under or between heated rollers 152. Forming the sheet 150 having at least one predetermined curvature may include passing the sheet through heated rollers 154. Stamping, die-cutting, or otherwise cutting the sheet into the device body may be performed by a die set comprising rollers 154 and a movable punch 156. The movable punch 156 may be bent to accommodate the curvature of the rollers 154 to simultaneously form the device body having at least one or more predetermined curvatures. 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 a medical grade adhesive suitable for topical use. It may take the form of a solid coating or layer (or multiple adhesive lines), double-sided tape, suction cups (one or more), or micro-suction cup tape. Any release liner may be applied simultaneously with or after the application of the adhesive.

When the device has ridges 246, the die set can be configured to stamp the ridges into the sheet or they can be assembled after stamping. Alternatively, the manufacturing method can include applying or attaching the ridges 246 to the inner surface of the bridge portion before, during, or after applying the adhesive to the inner surface.

An embodiment of a machine system 160 for implementing the method of manufacturing and packaging the device is shown in Figures 7A and 7B. The machine system 160 includes a longitudinal transport platform 161 that defines a conveying path P from a first end 162 downstream to a second end 164. At or near the first end 162 is a dispenser roll 166 for sheet material 167. The sheet material is stored in roll form and advantageously has a pre-formed curve. At that end, the dispenser roll 166 in one embodiment of the present invention has an initial diameter of 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, which is configured to flatten the sheet material and remove wrinkles or ridges. Downstream of the smooth roller 168 is a tape applicator roller 172, which applies a strip of double-sided adhesive tape 174 to the upward facing surface 175 of the sheet material (which becomes the inner/skin-facing surface of the device). The strip 174 is secured to the applicator roller 172 with its exposed adhesive surface 171 facing outward so that it contacts and adheres to the upward facing surface 175 of the sheet material 167 after pressure is applied by the roller 172. When the device is applied, a release liner strip 173 is attached to the opposite surface of the applied strip 174 for later removal by the user.

Downstream of the applicator roller 172 is a die press 179 having an upper platen 176 and lower platens 178A and 178B driven by air hydraulics 180. The upper platen 176 is driven toward the first lower platen 178A in a first phase of die press operation and toward the second lower platen 178B in a second phase of die press operation, as described below, to die-cut a plurality of individual devices 10A and 10B from the sheet material 167 and the strip 174 attached thereto.

The lower platens 178A and 178B are supported on a carrier 182 adapted for translational movement in opposite directions T1 and T2 along a path generally transverse to the transport path P. In a first phase of operation ( FIG. 7A ), the carrier 182 slides in direction T1 to position the first lower platen 178A just below the upper platen 176 , wherein the upper platen 176 engages the first lower platen 178A and cuts the device 10A in the die recess 181A, exposing the second lower platen 178B away from the side of the transport platform 161 and proximate to the transport member 184B. In the second phase ( FIG. 7B ), the carrier 182 slides in direction T2 to position the second lower platen 178B just below the upper platen 176, wherein the upper platen 176 engages the second lower platen 178B and cuts the device 10B in the die recess 181B, exposing the first lower platen 178A on the opposite side of the transfer platform 161 and bringing it into proximity with the opposing transfer member 184A. Thus, the carrier 182 translates each lower platen 178A and 178B between an engaged position below the upper platen 176 and an unloaded position below the respective transfer member 184A. A complete punching cycle of the press includes sequential first phase operations followed by second phase operations, wherein the hydraulic assembly drives the press 179 and the carrier 182 in such a manner that one of the lower platens is positioned below the upper platen 176 for punching, while the other lower platen is exposed and in proximity with the respective transfer member 184. That is, during one phase of operation, one lower deck is in the engaged position and the other lower deck is in the unloaded position, and during the other phase of operation, the other lower deck is in the engaged position and one lower deck is in the unloaded position.

In addition to driving the molding press 179 and carrier 182, the hydraulics 180 also drives the support arms 185 to move the transfer members 184A and 184B between at least three positions: a waiting position, a loading position, and an unloading position. The transfer members are adapted to secure a load of devices and transfer the devices from the lower platens 178A and 178B to a packaging or dispenser 183 disposed on tray members 186A and 186B, which are disposed in their exposed positions beneath the lower platens. As shown in FIG7A , when the lower platen 178B is exposed and in proximity to the transfer members 184B, the transfer members 184 are actuated by the hydraulics 180 to move from their waiting position to the loading position, where they pick up the devices 10B from the lower platen 178B. In the illustrated embodiment, the transfer members 184 include grippers, including vacuum/suction cups 189 mounted on posts 190, which are activated to individually grasp the devices 10B. After loading the device onto the plate, the transport member 184B is actuated by the hydraulic member 180 to move toward the tray member 186B located below the exposed position of the lower platen 176B into the unloading position and release the device 10B into the dispenser 183B. When the lower platen 176B contains more cutting devices and is exposed and accessible again, the transport member 184B then returns to its waiting position for the next cycle.

The tray assembly 186B is supported on a carrier 188B that translates the tray assembly 186B in a direction C parallel to the conveying path P so that the tray assembly 186B can be transitioned between different positions for efficient loading of the dispenser 184. In the illustrated embodiment, the tray assembly translates between two positions: a proximal position and a distal position.

It should be understood that the activation and movement of the embossing machine 179, carrier 182, transfer members 184A and 184B, and carrier 188 can be coordinated and synchronized with one another as desired or appropriate for efficient operation of the machine system. For example, the upper platen 176 can be driven to engage the lower platen 178A when the support arm 185B is driven to pick up the device 10B from the lower platen 178B, and when the support arm 185A is releasing the device into the dispenser 181A. Suitable systems and machines for transferring workpieces are described in U.S. Patent No. 8,230,989, entitled SHUTTLE MACHINE FOR MACHINE TOOL, the entire contents of which are incorporated herein by reference.

The spent sheet material 167 downstream of the die press 179 is pulled downstream by a servo driven roller 190 and collected on a waste roller 192 at the second end 164 of the transfer platform 161.

Another embodiment of the present invention is shown in Figures 8A-8C. Device 400 has a thin sheet body 402 that has been formed with an elevated central profile. Body 402 has a support portion 402 and a raised, planar central bridge portion 408. Support portion 402 is adapted for placement on the skin over a sensitive underlying area, such as the temples 132, as shown in Figure 9. Support portion 402 includes an outer edge or base 450 and radially extending L-shaped legs or posts 454 projecting therefrom, connecting base 450 and bridge portion 408. Base 450 is adapted to be placed on and generally surround the skin over a sensitive underlying area, such as the temples 132, as shown in Figure 9. Between adjacent pairs of legs are openings 456. As better seen in Figures 8D-8F, each leg has a radial portion 460 coplanar with bridge portion 408 and an axial portion 462 extending between the radial portion and base 450. The axial portion 462 may extend from the base 450 at an angle of about 45 to 120 degrees, preferably between about 60 to 100 degrees, and more preferably about 90 degrees. The plurality of legs 454 ranges between about two and five.

8A-8F , the illustrated embodiment of the device has three legs 454 positioned equidistant from one another (e.g., centered at approximately 0, 120, and 240 degrees) and three openings 456. Furthermore, each leg presents a 90-degree angle between a radial portion 460 and an axial portion 462, and also between the axial portion 462 and the base 450. The width of the legs can vary, depending on the desired flexibility of the plurality of legs and the bridge portion 408. The inner surface 406 of the bridge portion 408 has an adhesive component or adhesive 426, such as an adhesive coating or layer, tape, or micro-cup tape, as described above. The inner surface of the side 450 can also be provided with an adhesive component or adhesive to assist in securing the device to the skin.

In one embodiment, the outer radius r of the base 450 is 1.375 inches, the radius R of the bridge portion 408 is 0.5 inches, the width WA of the axial portion 462 is 0.625 inches, and the width WB of the base 450 is 0.125 inches. The height H of the bridge portion 408 from the base 450 is 0.1875 inches, and the thickness of the body 402 of the device 10 is 0.015 inches.

The base 450 and the bridge portion 408 can each be any shape, for example, rectangular, polygonal, oval or circular. In the illustrated embodiment, the base and the bridge portion are both circular.

In use, adhesive 426 is exposed and device 400 is placed over a target skin site, with the base generally surrounding the site and adhesive 426 facing the skin and tissue, as shown in FIG8D . Elevated by legs 454, bridge portion 408 is positioned above the skin, separated by a gap generally equal to height H. With the device so positioned, pressure P is applied by the user (or an assistant) to outer surface 404 of bridge portion 408 toward the skin to deform upper body 452 (including either bridge portion 408 and/or legs 454), bringing bridge portion 408 into contact with the skin and allowing adhesive 426 to adhere to the skin, as shown in FIG8E .

When pressure is removed and the upper body 452 is peeled away, the elastically deformable body 402 springs back and generally returns to a height at or near its original height, with the bridge portion 408 lifting the attached skin and tissue and reducing compression at the site.

As shown in FIG8D , the bridge portion 408 and radial leg portions 460 may extend perpendicularly relative to the axial leg portions 462, or portions 408 and 460 may have at least one predetermined curvature in one direction. As shown in FIG8F , the device 400′ has an upper body 462′ having curvature in more than one axial direction to provide a concavity toward the inner surface 406 forming a raised dome.

The device of the present invention can be worn at all times, or only during designated periods, such as at night or during sleep. Each device can be reused as long as the adhesive is effective. If it is not effective, the device can be discarded, or new adhesive can be applied to the device over or in place of the used adhesive. Due to the low cost of the device and its components, the device can be economically disposed of or recycled.

Referring to FIG10 , the device 400 may be manufactured as follows:

1. Forming device;

(a) Injecting, pressing, or vacuum forming the base 450, bridge portion 408, and 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 through a heat tunnel 471; and/or

2. Heated by heated roller(s) 472.

(ii) stamping, die-cutting, or otherwise cutting the sheet to form base 450, bridge portion 408, and legs 454;

1. Use die set 473 to punch out opening 456 to form the legs;

2. Apply adhesive 426 to the inner surface 406 of the bridge portion 408 .

Stamping, die-cutting, or otherwise cutting the sheet may include cutting the base 450, bridge portion 408, and legs 454 from the sheet and reshaping/reshaping to provide a curvature in the upper body 452 and/or an angle or bend in the legs 454 for lifting the bridge portion 408 from the base 450. Application of the adhesive 426 may occur before, during, or after stamping, die-cutting, or otherwise cutting the sheet.

In another embodiment of the present invention, device 500 can be worn as a belt or sleeve around a limb or part thereof. With reference to Figure 10, device 500 is extended to define a length axis L and a width axis W. Device 500 has a generally rigid but pliable main body 511 having a planar, generally rectangular form and two fastening side portions 513, each having a generally rectangular form and adjoining opposite side edges 515 of the main body 511. The main body 511 can be made of the same aforementioned suitable material. The side portions 513 can be made of elastic, stretchable material or fabric. On the inner surface 506 of the main body 511, an adhesive component 526 is provided and positioned between the projections 546 of at least two bridge portions 508 that limit elevation.

In use, the device 500 is positioned on a limb, for example, on a forearm (FIG. 12), thigh, or foot (FIG. 13), with the exposed adhesive component 526 and projection 546 facing the skin above the treatment site. The side portions 513 surround the limb and are releasably fastened to each other by fasteners 517, for example, hook and loop fasteners, eye and hook fasteners, snap fasteners, etc. The device 500 in a neutral configuration presents a portion 508 of the bridge in an elevated position above the skin, the two being separated by a gap. When pressure is applied to the outer surface 504 of the bridge portion 508, the device takes a deformed configuration so that the adhesive component 526 begins to contact 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 slightly preset curve or concave surface in the L axis toward the inner surface 506 to better fit the limb.

In another embodiment of the present invention, a device 500' can be worn as a cuff around the wrist, as shown in Figure 12. Device 500', shown in Figure 11, has a similar construction to device 500 of Figure 10, except that the device is smaller and has a significant pre-set curve or concavity in the L-axis toward the inner surface 506 to better fit the wrist.

The present invention also includes a method of making a customized treatment device, wherein a mold of the treatment site, eg, the palm, forearm, thigh, is prepared and a set of dies for making the device is customized based on the mold.

The foregoing description has been presented with reference to the presently preferred embodiments of the invention. It will be understood by those skilled in the art and technology to which the invention pertains that changes and variations of the described structures may be implemented without intentionally departing from the principles, spirit and scope of the invention. As will be appreciated by those skilled in the art, the drawings are not necessarily to scale. The dimensions of the device may be modified to accommodate users of different sizes. As mentioned above, the device may have more than one adhesive or adhesive component that may be applied to different areas of the device beyond the bridge portion. Therefore, the foregoing description should not be read as pertaining solely to the precise structures described or illustrated in the drawings, but rather should be read as consistent with and supporting the claims which follow in their fullest and unbroken scope.

Claims (5)

1. Suitable therapeutic devices for reducing pain associated with carpal tunnel syndrome by lifting the skin above the median nerve in the palm of the hand, including: A typically rigid but elastically deformable sheet body, the sheet body having a first surface and a second surface, the sheet body defining a longitudinal dimension and a transverse dimension, the sheet body having: The bridge portion has a first surface with an adhesive suitable for bonding to the skin over the median nerve in the palm, wherein the bridge portion is a rectangle having a length extending in the lateral dimension and a width extending in the longitudinal dimension; and Two support wings, each extending outward from the bridge portion in opposite directions along the longitudinal dimension, each wing having a rounded outer free edge, each wing having a wider portion in the lateral dimension away from the bridge portion and a narrower portion in the lateral dimension closer to the bridge portion, wherein the two support wings are unadhesive. 2. The treatment device of claim 1, wherein the bridge portion is narrower than each wing in the longitudinal dimension. 3. The treatment device of claim 1, wherein the sheet body spans between 2 ^1/2 _inches and 2 ^3/4 _inches in the longitudinal dimension and between 1 ^1/2 _inches and 1 ^3/4 _inches in the transverse dimension. 4. The treatment device of claim 1, wherein the bridge portion spans 3/8 inch in the longitudinal dimension of the sheet body. 5. The treatment device of claim 1, wherein the bridge portion is adapted to be linearly positioned between the abductor digiti minimi muscle and the abductor pollicis brevis muscle of the human hand.