System for treatment of plantar fasciitis

An stretch resistant plantar fascia support system is provided. The stretch resistant plantar fascia support system is adhesively applied to the foot of a patient for providing relief from plantar fasciitis. A portion of the stretch resistant plantar fascia support system is adhesively attached to the bottom surface of the foot for reducing stress on the plantar fascia.

Not Applicable.

REFERENCE TO MATERIALS ON COMPACT DISC

Not Applicable.

BACKGROUND OF THE INVENTION

The present invention generally relates to a stretch resistant plantar fascia support system. More particularly, the present invention relates to a stretch resistant plantar fascia support system that may be adhesively applied to a foot to provide relief from plantar fasciitis.

FIG. 1is a dissected bottom view of a human foot100provided to illustrate some of the parts of a plantar fascia110located in the bottom of the human foot100. As shown inFIG. 1, the plantar fascia110extends from about the location of the heel101to about the location of the ball102of the foot. The plantar fascia110includes medial plantar fascia120, superficial tracts130, a central component of the plantar fascia140, and a lateral component of the plantar fascia150. The separate portions of the plantar fascia110act as a shock absorber while walking and transfer tensile forces along the bottom of the foot100.

FIG. 2illustrates a simplified side view of tissue and bone structure in the human foot100. As shown inFIG. 2, the human foot100includes the plantar fascia110, a plantar calcaneus160, a talus162, a navicular164, a cuneiform166, a cuboid168, metatarsals170, phalanges172, a sesamoid174, a fat pad area176, and an outer skin surface178. From the side view inFIG. 2, the plantar calcaneus160, the talus162, the navicular164, the cuneiform166, the cuboid168, the metatarsals170, and the sesamoid174form what resembles the shape of an arch. This shape is commonly referred to as the longitudinal arch. Another arch commonly referred to as the transverse arch (metatarsal) also exists in about the same area in a perpendicular direction that runs laterally across the width of the foot.

The plantar fascia110serves the vital role of maintaining the shape of the two anatomical arches of the foot, the transverse arch and the longitudinal arch. As illustrated inFIGS. 1 and 2, the plantar fascia110runs across the bottom of the foot100from the heel101to the ball102and spreads out across the width of the foot100. As longitudinal and lateral tensile stresses are produced in the bottom of the foot100, the plantar fascia110absorbs the tensile forces and maintains the shape of the two anatomical arches.

For example, while standing or while in motion, forces experienced by the foot100act in a direction which tends to flatten the arches. The stress line300inFIG. 2shows an approximation of the line of forces transferred through foot100during typical motion. As shown inFIG. 2, the stress line300resembles the shape of an archer's bow. The plantar fascia110running along near the bottom surface of the foot100is analogous to a string in the archer's bow. Forces that tend to move the ends of the bow apart increase tension on the string. In other words, as forces on the arch push the bones downward, the plantar fascia110is subjected to tensile forces.

If the tension on the plantar fascia110becomes excessive, the plantar fascia110may be damaged and produce a condition called plantar fasciitis. Plantar fasciitis is a painful medical condition resulting from inflammation of the plantar fascia110. The plantar fascia110is thick and essentially inelastic. Overstressing the plantar fascia110may produce tears in the plantar fascia110or separate the plantar fascia110from bone and other surrounding materials. Tearing and separation of the plantar fascia110produces the painful inflammation known as plantar fasciitis. Frequently, the inflamed areas305are along the arch of the foot100or near the heel101of the foot100as shown inFIG. 2.

Plantar fasciitis may be quite debilitating in that everyday activities such as walking and standing may be very painful. Typical treatments for plantar fasciitis may involve oral anti-inflammatories, ice packs, bedrest, stretching, steroid injections, night splints and wedge-shaped arch supports. In extreme cases, treatment of plantar fasciitis may require corrective surgery.

For example, a design for an orthotic device for treatment of plantar fasciitis is disclosed in Gleason, U.S. Pat. No. 5,865,779. The device of Gleason is an elastic sock that is worn on a patient's foot. The elastic sock exerts compressive forces along the longitudinal and transverse axes of the patient's foot.

While some patients may be willing to wear an elastic sock, the elastic sock is both inconvenient and cumbersome. In order to be installed on the foot, the elastic sock must be stretched to fit over the heel and toe of the foot. Because the sock is elastic, the sock allows the foot to move and stretch. Consequently, the plantar fascia may still be subjected to excessive tensile forces during the critical heeling process. Re-subjecting the plantar fascia to tensile forces before it has completely healed may re-aggravate damaged portions of the plantar fascia and undermine the healing process.

In addition, the elastic sock is meant to be worn multiple times and may require regular cleaning to avoid odors and foot infections. Also, the sock may not fit inside a shoe while being worn and may be considered unsightly while walking around with bare feet. Consequently, the elastic sock does not prevent excessive stretching of the plantar fascia and is both inconvenient and cumbersome.

Another typical example of treatment for plantar fasciitis includes medical personnel strapping strips of tape to the bottom of an injured foot. Strips of tape are applied at various angles across the bottom of the foot. The tape is difficult to remove from the rolls and bunches up during the taping process. Thus, care must be exercised during the application of the tape to avoid blister-causing wrinkles in the tape and other problems.

As the patient walks with the taped foot, the tape works loose and stretches with time. In addition, the tape cannot be effectively applied by the patient to the patient's own foot and requires application by another individual such as a trained medical technician. Consequently, taping the foot is cumbersome, inefficient, and ineffective in preventing excessive stretching of the plantar fascia.

Sometimes when current methods of treatment for plantar fasciitis are ineffective, expensive surgical procedures are required to relieve the pain of plantar fasciitis. To get at the plantar fascia, surgeons may perform either an endoscopic procedure requiring small incisions or conventional direct visualization requiring the underside of the foot to be opened up. With either painful procedure, scars may result and recovery time may be from weeks to months.

Even with treatment, improper treatment of plantar fasciitis may lead to other medical problems. For example, if inflammation near the heel is allowed to continue for a long period of time, calcium deposits may build-up in the damaged region. As the calcium builds-up, bony outcroppings may develop in the heel that are commonly referred to as “heel spurs”. The longer the plantar fascia remains inflamed around the heel, the stronger the conditions are for the development of heel spurs. Protrusion of the heel spurs into the surrounding tissue may result in a cycle of irritation, inflammation, and pain known as heel spur syndrome.

Heel spur syndrome is commonly treated with a surgical procedure requiring removal of the heel spurs from within the foot. An endoscopic procedure is typically not used for removal of heel spurs and open surgery is typically required. Recovery time from such surgery may range from weeks to months, during which time the patient has to curtail the amount of stress placed on the foot.

Thus, it may be highly desirable to have a system for avoiding and/or treating the pain of plantar fasciitis. It may also be highly desirable to have a system for treating plantar fasciitis that is economical and may be easily applied by the patient. It may also be highly desirable to have a system for treating plantar fasciitis that is discretely attached to the sole of the patient's foot and includes a substantially stretch resistant material to reduce tensile forces in the plantar fascia.

BRIEF SUMMARY OF THE INVENTION

A preferred embodiment of the present invention provides a system for treatment of plantar fasciitis. The system is economical and may be easily applied by a patient.

A stretch resistant plantar fascia support system is provided with a foot sole support. The foot sole support may be a thin one-piece device made of a uniform substantially stretch resistant material of a uniform thickness or the foot sole support may be made with a strip of substantially stretch resistant material bounded by a more deformable material. The foot sole support may be shaped to conform to the outline of the bottom of a foot or shaped to cover only a portion of the bottom of a foot. Straps and tabs may be included with the foot sole support for providing additional support to both the foot and other portions of the stretch resistant plantar fascia support system. The foot sole support, straps, and tabs have adhesive applied to portions of the surface of the foot sole support, the straps, and the tabs. Removable protective covers are applied over the adhesive and the removable protective covers may include indicia signifying the order in which the portions of the stretch resistant plantar fascia support system are to be applied to the foot.

To relieve the symptoms of plantar fasciitis, tensile stresses in the plantar fascia are reduced. The tensile stresses in the plantar fascia are reduced by adhering the foot sole support to the foot of the patient. The foot sole support absorbs tensile stress in the lower foot thereby reducing the tensile stress experienced by the plantar fascia and surrounding tissues. The straps and tabs may be attached in the prescribed order to the foot sole support and wrapped around or attached to portions of the foot to provide additional support to the stretch resistant plantar fascia support system.

Certain embodiments of the present invention include an article of manufacture that is a kit for at least one of providing anatomical support to the arch of the foot, treating arch pain, treating heel pain, increasing tissue healing and rehabilitation in a human afflicted with plantar fasciitis, and preventing injury to the plantar fascia. The kit includes a sheet of material having a support layer, an adhesive layer for applying at least a portion of the support layer to the foot, and a cover layer that covers at least a portion of the adhesive layer and that may be removed from the support layer and adhesive layer. The kit includes instructions for applying the support layer to the foot for at least one of supporting the arch, reducing stress on the plantar fascia or surrounding tissues, and treating plantar fasciitis. The kit includes packaging carrying the sheet and instructions.

Certain embodiments of the present invention include a kit for managing foot pain. The kit includes a sheet of material configured to be affixed to at least a portion of a foot, the sheet including a stretch resistant support layer joined to a cover layer by adhesive, wherein the cover layer is removed from the adhesive and the support layer is affixed to the portion of the foot by the adhesive. The kit includes instructions instructing how to apply the support layer to the portion of the foot.

Certain embodiments of the present invention include a process for controlling stress on a plantar fascia of a foot. The process includes providing a sheet of material and instructions for using the sheet of material to control stress on the plantar fascia, wherein the sheet has a stretch resistant support layer joined to a cover layer by adhesive. The process includes reviewing the instructions, conforming the sheet of material to the shape of a portion of a foot, removing the cover layer from the adhesive and the support layer, applying the support layer to the portion of the foot such that the adhesive retains the support layer to the portion of the foot, and adjusting the support layer to the portion of the foot where the applying step results in an unsatisfactory application.

Certain embodiments of the present invention include an article of manufacture for managing foot pain. The article includes a sheet of material including a substantially stretch resistant Rayon support layer having a thickness of less than 15 mils, an adhesive layer, and a release liner. The sheet of material is configured to be conformed with cutting tools to the shape of at least a portion of the human foot. The support layer of the conformed sheet is affixed to the foot by the adhesive layer in order to control stress on the plantar fascia or support the arch of the foot.

Certain embodiments of the present invention include a sheet of material having a Rayon layer having a nominal thread count of 3600, a hypoallergenic adhesive on the layer, and a release liner affixed to the adhesive. The sheet of material has a thickness of less than 30 mils.

The foregoing summary, as well as the following detailed description of certain embodiments of the present invention, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there is shown in the drawings, certain embodiments. It should be understood, however, that the present invention is not limited to the arrangements and instrumentality shown in the attached drawings.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 3illustrates a stretch resistant plantar fascia support system400in accordance with an embodiment of the present invention. The stretch resistant plantar fascia support system400includes a foot sole support410, an adhesive layer411, indicia415, removable protective covers416, arch straps420, heel strap430, heel strap tabs432, toe strap440, toe strap tab442, front straps450, and heel tabs460.

The arch straps420, the heel strap430, the toe strap440, the front straps450, and the heel tabs460are connected to the foot sole support410. The arch straps420project from the sides of the foot sole support410approximately midway along the longitudinal axis of the foot sole support410. The heel strap430projects from the back edge of the foot sole support410and the heel strap tabs432project from the sides of the heel strap430. The toe strap440projects from the front edge of the foot sole support410and the toe strap tab projects from a side of the toe strap440. The front straps450project from the sides of the of the foot sole support410adjacent the front edge of the foot sole support410. The heel tabs460project from the sides of the foot sole support410adjacent the back edge of the foot sole support410.

The adhesive layer411is applied to the top or inner surface of the foot sole support410, the arch straps420, the heel strap430, the toe strap440, the front straps450, and the heel tabs460. The removable protective covers416are removably adhered to the adhesive layer411. Indicia415are printed on the removable protective covers416.

In operation, the stretch resistant plantar fascia support system400is adhesively attached to a human foot100. To adhesively attach the stretch resistant plantar fascia support system400to the human foot100, the removable protective cover416adhered to the top of the foot sole support410is removed. The foot sole support410is pressed against the outer skin surface178on the bottom of the human foot100.

Adhesion of the foot sole support410to the outer skin surface178on the bottom of the human foot100prevents extension and stretching of tissue on the bottom of the foot. By restricting extension of the tissue on the bottom of the foot, the level of tensile stress on the plantar fascia is reduced.

In the alternative, adhesive may be applied to select portions of the foot sole support410, the straps420,430,440and450, and the tabs432,442, and462. For example, to reduce the chance of irritation to sensitive skin regions along an arch of the foot or to accommodate users with high arches, adhesive may only be applied to the portion of the foot sole support410contacting the ball of the foot and the heel of the foot.

In another alternative embodiment, adhesive may be applied to the sole of the foot. For example, adhesive sprays may be used to spray an adhesive layer on select portions of the foot. If a strong enough adhesive spray is used that would hold the foot sole portion410in place, then the stretch resistant plantar fascia support system400may be supplied without the adhesive layer411and removable protective covers416.

To help maintain the position of the foot sole support410on the bottom of the human foot100and further reduce tensile stress on the plantar fascia, the arch straps420may be wrapped laterally over the arch of the foot. To install the arch straps420, the removable protective cover416adhered to the inner surface of the arch straps420is removed. The arch straps420are then wrapped up and over the top of the foot100. To secure the arch straps420in place, one of the arch straps420may overlap another arch strap420and be adhered to the outer surface of the other arch strap420.

In the alternative, only one arch strap420may be used. With only one arch strap420, the arch strap420may wrap laterally over the top of the arch and adhere to the bottom surface of the foot sole support410on the opposite side of the foot100.

In another alternative embodiment, only one arch strap420may be used and the arch strap420may be separate and distinct from the foot sole support410. With the foot sole support410already installed on the bottom of the foot100, the arch strap420may be adhered to the foot sole support410on one side of the foot100. The arch strap420may then be wrapped laterally over the arch, down the opposite side of the foot100, and adhered to the foot sole support410on the opposite side of the foot100.

Installation of the arch straps420also reduces stress on the plantar fascia. As presented earlier with regard toFIG. 2, the stress line300inFIG. 2resembles an archer's bow. The stress line300passes through the talus162, the navicular164, the cuneiform166, and the cuboid168. Laterally wrapping the arch straps420over and around the top of the foot near the arch provides resistance to vertical and lateral movement of the talus162, the navicular164, the cuneiform166, and the cuboid168. Provision of the resistance to vertical and lateral movement by the arch straps420reduces flexure of the “bow” and related changes in stress on the plantar fascia.

To provide extra support to the heel of the human foot100and help maintain the position of the foot sole support410on the bottom of the human foot100, the heel strap430may be adhered to the heel of the foot100. To further support the heel and help maintain the position of the foot sole support410, the heel strap430includes heel strap tabs432. To install the heel strap430and heel strap tabs432, the removable protective cover416adhered to the inner surface of the heel strap430and heel strap tabs432are removed. The heel strap430is then pressed against the back of the heel of the foot100and secured in place by contact between the adhesive layer411and the outer skin surface178. The heel strap tabs432are pressed against the outer skin surface178along the sides of the heel of the foot100.

In an alternative embodiment, the stretch resistant plantar fascia support system400may include a heel strap430without heel strap tabs432. The heel strap430may be installed as described above by removing the removable protective cover416and adhering the heel strap430to the back of the heel.

Installation of the heel strap430provides extra support to the heel and helps maintain the position of the foot sole support410. Adhesion of the heel strap430to the back of the heel provides an anchor point for the rear portion of the foot sole support410. During the course of walking, the foot sole support410may be subjected to lateral and longitudinal forces from contact between the foot sole support410and other surfaces such as the interior of shoes or floor surfaces. Depending on the level of the lateral and longitudinal forces, the resistance to lateral and longitudinal forces provided by the adhesive layer411may be exceeded. Adhering the heel strap430to the heel of the foot100provides extra resistance to lateral and longitudinal forces that may otherwise cause the foot sole support410to shift around on the bottom of the foot.

Additionally, the heel strap430provides extra support to the heel of the foot100. The human foot has a complex structure of tissue and bones. Tissues in the heel interact with other tissues in the foot to transfer forces exhibited during walking. As shown inFIG. 1, portions of the plantar fascia attach to the heel and other tissues that continue up around the back of the heel. Through these attachments, tissues in the heel transfer forces to and from the plantar fascia. Providing extra support to the heel of the foot100reduces the amount of stress transferred between the heel and the plantar fascia.

The stretch resistant plantar fascia support system400also includes heel tabs460. Similar to the heel strap430, the heel tabs460assist in maintaining the position of the foot sole support410. To install the heel tabs460, the removable protective covers416adhered to the inner surface of the heel tabs460are removed. The heel tabs460are then pressed against the sides of the heel of the foot100and secured in place by contact between the adhesive layer411and the outer skin surface178. As the foot sole support410is subjected to lateral and longitudinal forces, the heel tabs460provide additional resistance to the lateral and longitudinal forces to help maintain the installed position of the foot sole support410.

The stretch resistant plantar fascia support system400also includes front straps450. The front straps450assist in maintaining the position of the foot sole support410and provide extra support to the area near the ball of the foot100. To install the front straps450, the removable protective covers416adhered to the inner surface of the front straps450are removed. The front straps450are then wrapped up and over the top of the foot100. To secure the front straps450in place, one of the front straps450may overlap another front strap450and be adhered to the outer surface of the other front strap450.

In the alternative, only one front strap450may be used. With only one front strap450, the front strap450may wrap laterally over the top of the foot100and adhere to the bottom surface of the foot sole support410on the opposite side of the foot100.

In another alternative embodiment, only one front strap450may be used and the front strap450may be separate and distinct from the foot sole support410. With the foot sole support410already installed on the bottom of the foot100, the front strap450may then be adhered to the foot sole support410on one side of the foot100. The front strap450may then be wrapped laterally over the foot100, down the opposite side of the foot100, and adhered to the foot sole support410on the opposite side of the foot100.

During the course of walking, the foot sole support410may be subjected to lateral and longitudinal forces from contact between the foot sole support410and other surfaces such as the interior of shoes or floor surfaces. Depending on the level of the lateral and longitudinal forces, the resistance to lateral and longitudinal forces provided by the adhesive layer411may be exceeded. Adhering the front straps450near the ball of the foot100provides extra resistance to lateral and longitudinal forces that may otherwise cause the foot sole support410to shift around on the bottom of the foot.

Installation of the front straps450also reduces stress on the plantar fascia. As shown inFIG. 1, portions of the plantar fascia attach to the ball of the foot and other portions such as the superficial tracts130continue past the ball of the foot100to the toe region. Due to the complex structure of tissue and bones in the human foot, tissues near the ball of the foot interact with other tissues in the foot to transfer forces induced during walking. Through the attachments near the ball of the foot, tissues near the ball of the foot transfer forces to and from the plantar fascia110. Providing extra support near the ball of the foot100reduces the amount of stress transferred between the ball of the foot and the plantar fascia110.

The stretch resistant plantar fascia support system400includes a toe strap440. Installation of the toe strap440assists in maintaining the position of the foot sole support410. To install the toe strap440, the removable protective cover416adhered to the inner surface of the toe strap440is removed. The toe strap440is then pressed against the underside of the toe and the adhesive layer secures the toe strap440in place.

To further secure the toe strap440in place, the toe strap440includes a toe strap tab442. To install the toe strap tab442, the removable protective cover416adhered to the inner surface of the toe strap tab442is removed. The toe strap tab442is then wrapped up and over the top of the toe of the foot100. The toe strap is wrapped back down the opposite side of the toe and adhered to the underside of toe strap440on the opposite side of the toe.

In the alternative, more than one toe strap tab442may be attached to the toe strap440. For example, a second toe strap tab may be positioned opposite the toe strap tab shown inFIG. 3on the opposite side of the toe strap440. To install the toe strap tabs442, the removable protective cover416adhered to the inner surface of the toe strap tabs442is removed. The toe strap tabs442are then wrapped up and over the top of the toe. To secure the toe strap tabs442in place, one of the toe strap tabs442may overlap the other toe strap tab442and be adhered to the outer surface of the other toe strap tab442similar to the arch straps420shown inFIG. 3.

In another alternative embodiment, only one toe strap tab442may be used and the toe strap tab442may be separate and distinct from the toe strap440and the foot sole support410. With the toe strap440already installed on the bottom of the toe, the toe strap tab442may then be adhered to the toe strap440on one side of the toe. The toe strap tab442may then be wrapped laterally over the toe, down the opposite side of the toe, and adhered to the toe strap440on the opposite side of the toe.

The stretch resistant plantar fascia support system410may also include indicia415printed on the removable protective covers416. The indicia415may represent instructions for the installation of the stretch resistant plantar fascia support system410. For example, the indicia415may be numerical or alphabetic designations for the order in which portions of the stretch resistant plantar fascia support system410are to be installed. InFIG. 3, the indicia415on the removable protective cover416over the foot sole support410is the number “1” designating that the foot sole support410is to be installed first. The indicia415on the removable protective cover416on the arch straps420is the number “2” designating that the arch straps420are the next portion to be installed. Thus, the indicia may be increased or decreased incrementally to designate the order in which the portions of the stretch resistant plantar fascia support system400are to be installed.

In the alternative, letters or words may be used instead of numerals as the indicia415to designate the order in which the portions of the stretch resistant plantar fascia support system400are to be installed. For examples, letters “A”, “B”, and “C” or the words “First”, “Second”, and “Third” may be used to designate the order in which the first three portions are to be installed.

In the alternative, the indicia415may be printed on the various portions of the stretch resistant plantar fascia support system400. For example, if an adhesive spray is applied to the skin rather than using an adhesive layer411and removable protective covers416, the indicia415may be printed on the inner surface of components such as the foot sole support410and a consumer may still be able to see the indicia and determine the order of application.

In an alternative embodiment, the stretch resistant plantar fascia support system400may include the foot sole support410without the arch straps420, the heel strap430, the toe strap440, and front strap450and the heel tabs460. Similar to the embodiment shown inFIG. 3, the foot sole support410would be adhesively applied to the bottom surface of the foot.

In the alternative, the stretch resistant plantar fascia support system400may include various combinations of the arch straps420, the heel strap430, the toe strap440, and front straps450and the heel tabs460. For example, an alternative embodiment of the stretch resistant plantar fascia support system400may include the foot sole support410with arch straps420. Another alternative embodiment of the stretch resistant plantar fascia support system400may include the foot sole support410with the heel strap430. Yet another alternative embodiment of the stretch resistant plantar fascia support system400may include the foot sole support410with the toe strap440. Consequently, various alternative embodiments of the stretch resistant plantar fascia support system400may be used that include the foot sole support410with different combinations of the arch straps420, the heel strap430, the toe strap440, and front strap450and the heel tabs460.

FIG. 4illustrates a stretch resistant plantar fascia support system500as an alternative embodiment of the stretch resistant plantar fascia support system400ofFIG. 3installed on a human foot. The alternative embodiment shown inFIG. 4includes a foot sole support410, arch straps420, heel strap430, heel strap tabs432, toe strap440, and toe strap tab442.

As shown inFIG. 4, the foot sole support410may be adhered to the sole of the foot to provide additional support to the region underneath the plantar fascia. The arch straps420may be wrapped around the top of the foot to provide additional support near the arch. The heel strap430may be adhered to the back of the heel to provide additional support to the heel and stabilize the position of the foot sole support410. The toe strap440may be adhered to the bottom of the toe and the toe strap442wrapped around the toe to provide additional support to the toe and stabilize the position of the foot sole support410.

FIG. 5illustrates stresses in the human foot100shown inFIG. 2with a stretch resistant plantar fascia support system400attached to the human foot100in accordance with an embodiment of the present invention. As described previously with regard toFIG. 2, the stress line300shows an approximation of the line of forces transferred through a foot100during typical motion. The stress line300resembles the shape of an archer's bow. The plantar fascia110running along near the bottom surface of the foot100is analogous to a string in the archer's bow. Forces that tend to move the ends of the bow apart increase tension on the string. In other words, as forces on the arch push the bones downward, the plantar fascia110is subjected to tensile forces.

To reduce the tensile forces on the plantar fascia110, the stretch resistant plantar fascia support system400is attached to the bottom of the foot. As depicted inFIG. 5, the stretch resistant plantar fascia support system400is analogous to another string in the archer's bow connected in parallel with the plantar fascia110. Tensile forces induced in the bottom of the foot are shared between the plantar fascia110and the stretch resistant plantar fascia support system400. Consequently, tensile force in the plantar fascia110is reduced and damaged areas may heal with a reduced likelihood of being subjected to excessive tensile forces.

Thus, a stretch resistant plantar fascia support system using a substantially stretch resistant material may be conveniently and easily applied to the foot of a patient by the patient for the treatment of plantar fasciitis. For example, the entire foot sole support, or portions of the foot sole support, of the stretch resistant plantar fascia support system may be made of a flexible material that exhibits less than 15 percent elongation when subjected to a251btensile load under test conditions specified in ASTM D3759. In addition, a material with a ratio of elongation to tensile strength (lb/in-width) that is less than 0.9 may be used to provide a balanced combination of strength and resistance to elongation.

Additionally, to simplify manufacturing and reduce cost, the stretch resistant plantar fascia support system may be made of a uniform material supplied in sheet form. Portions of the stretch resistant plantar fascia support system may be cut or punched from sheets of material. For example, the foot sole support may be shaped to resemble the outline of the sole of a left or right foot. Alternatively, the foot sole support may also be shaped for interchangeable use on either a left or right foot.

The stretch resistant plantar fascia support system may then be packaged individually, in multiples, or in a continuous package such as a roll with individual patches separated by perforations. For example, the individual packaging could be used by the average consumer for everyday use around the home. The continuous packaging could be used in high use situations such as locker rooms where access to stretch resistant plantar fascia support systems is required by multiple people.

Alternatively, the invention includes an article of manufacture that is an anatomical foot support kit for treating plantar fasciitis and other kinds of foot pain. The kit includes at least one sheet of stretch resistant material that can be adapted for application to the user's foot as a support system to treat plantar fasciitis, instructions that instruct the user on how to apply and use the support system, and packaging that allows for the distribution of the support system and instructions.

FIG. 6illustrates a top view of a sheet500of material. A support system504is formed and removed from the sheet500of material for use as the stretch resistant plantar fascia support system on the user's foot. The support system504is shaped to be applied to the user's foot or a portion of the foot. The support system504includes a sole portion502shaped for application to the sole of a foot, a ball strap506and heel tabs510for retaining the sole portion502to the foot or a portion of the foot. Alternatively, support system504may be shaped like the support system400shown inFIGS. 3 and 4or have any number of other shapes for being connected to the user's foot. The support system504may be shaped for either a left or a right foot. The support system504may be pre-cut or perforated into the sheet500for the user to punch out of the sheet500. Alternatively, the user may use cutting tools to cut the support system504from the sheet500along an outline imprinted on the sheet500or cut by freehand to suit the user's particular foot shape. The sheet500may be large enough to include more than one support system504. Alternatively, the sheet500may be smaller such that the user may remove multiple smaller portions of a single support system504from the sheet500for application to the foot. The sheet500may be manufactured by a number of different techniques. Additionally, the sheet500may be pre-cut or perforated to form the support system504by a number of different techniques. By way of example only, the sheet500may be cut by die-cutting or laser cutting.

FIG. 7illustrates an enlarged cross-sectional side view of the sheet500ofFIG. 6taken along lines7-7. Similar to the support system400ofFIG. 3, the sheet500includes a backing or support layer508, an adhesive layer512, and a removable protective cover layer or release liner516. Alternatively, the adhesive layer512may be an adhesive that is applied or coated to the support layer508. The sheet500has a generally uniform thickness. By way of example only, the sheet500may have a thickness of up to ⅜ inch. By way of example only, the thickness of the sheet500, including all three layers508,512, and516, may be less than 60 mils. By way of example only, the thickness of the sheet500, including all three layers508,512, and516, may be less than 45 mils. The relative thicknesses of the layers508,512, and516may vary from each other differently from what is shown inFIG. 7.

Returning toFIG. 6, the support layer508is made of a material having the mechanical integrity to provide support under cyclic loading for the duration of application to the user's foot without excessive elongation, fraying or other forms of degradation. The support layer508is sufficiently flexible so that it can conform to the shape of the section of the foot to which it is adhesively connected and provide structural support to the body part. The material of the support layer508may be made of a single layer or a plurality of layers. By way of example only, the support layer508may be less than 15 mils thick and by further way of example may be less than 5 mils thick. The support layer508more easily conforms to the shape of the foot where the material of the support layer508is thinner. Additionally, the support layer508may also be compliant and non-irritating to the skin of the user. Furthermore, the support layer508may be of any color. For example, the support layer508may be tan or a skin-tone color such that the support layer508is less visible when applied to the user's foot.

The material of the support layer508is substantially stretch resistant in at least one direction. By way of example only, the support layer508may exhibit less than 15 percent total elongation in at least one direction when subjected to a251btensile load under test conditions specified in ASTM (American Society for Testing and Materials) D3759. In addition, by way of example only, the support layer508may have a ratio of elongation to tensile strength (lb/in-width) that is less than 0.9 to provide a balanced combination of strength and resistance to elongation. By way of example only, the support layer508may have a tensile strength of greater than 10 lb/in-width per ASTM D-1000 and by further way of example may have a tensile strength of greater than 20 lb/in-width per ASTM D-1000.

The support layer508may be manufactured from a wide range of materials such as woven and non-woven materials, polymeric materials such as apertured formed thermoplastic films, or apertured plastic films, synthetic or natural fibers, or a combination of materials. By way of example only, the support layer may be made of a woven rayon microfiber with a 3600 thread count and/or thickness of less than 30 mils, or alternatively less than 15 mils, such that the stretch resistant plantar fascia support system is thin enough to comply with the contours of the foot and strong enough to provide adequate strength.

Additionally, the support layer508may be breathable. By way of example only, the support layer508may have a moisture vapor transfer rate (MVTR) of at least 100 g/24 h/m2. By way of example only, the support layer508may have a MVTR of greater than 400 100 g/24 h/m2.

The adhesive layer512includes an adhesive that provides the requisite degree of adhesion to hold the support layer508against the user's foot for the duration of use and is relatively easy to remove at the end of use. The adhesive on the adhesive layer512is non-toxic and non-allergenic or hypoallergenic and may or may not be vapor permeable. The adhesive may provide enough tack such that the support layer508may be easily applied and re-adjusted to the foot if necessary. The adhesive is highly resistant to slippage or movement caused by the potentially high sheer stresses of the application. By way of example only, the adhesive layer512may be less than 10 mils thick, and by further way of example may be less than 5 mils thick. By way of example only, the adhesive may provide a holding strength of greater that 15 oz/in when tested according to a PSTC-3 (Pressure sensitive tape council) standard Adhesion-to-Steel 180 degree Peel test. By way of example only, the adhesive may provide a holding strength of greater that 30 oz/in when tested according to the Adhesion-to-Steel 180 degree Peel test.

The release paper516is provided over the adhesive layer512. The release paper516should remain in place over the adhesive layer512until removed by the user. By way of example only, the release paper516may be made of 3.5 mil, 60# Kraft paper. The release paper516may include a tab518that can be pulled to easily remove the release paper516from the adhesive layer512. Alternatively, to ease removal of the support layer508of the support system504from the release paper516, the support layer508and the adhesive layer512that form the shape of the support system504may not be surrounded by any further support layers508or adhesive layers512on the release paper516such the surrounding release liner512is visible about the support system504. Alternatively, the sheet500may be the shape of the support system504so that the support system504does not need to be removed from a larger sheet. Thus, the user can simply remove the release paper516from the sheet500in order to apply the support system504.

As shown inFIG. 8, the sheet500(or multiple sheets500) may be provided in a package522for sales or distribution in stacked flat layers and sealed in a pouch or bag520with labeling524. By way of example only, the bag520may be cellophane or another suitable material. Alternatively, as shown inFIG. 9, the sheet500(or multiple sheets500) may be packaged by wrapping a plurality of sheets500about themselves in the shape of a roll528. A specific sheet, bearing reference numeral501, in a roll528is connected to an adjacent sheet, bearing reference numeral502, in the roll528along a perforation532. Alternatively, the user may unroll the sheets500and cut adjacent sheets501and502from each other. Alternatively, the roll528may include just one continuous sheet500wrapped about itself that the user may unwrap and cut where appropriate. The roll528may include a center spool (not shown) about which the sheet(s)500are wrapped. The roll528may be packaged in a labeled box or bag, or any number of other kinds of packaging.

Alternatively, the sheet500or multiple sheets500may be packaged in any number of other ways in boxes, bags, envelops, pouches, bottles, jars, cartons, packets, tubes, or any combination thereof or any number of other forms of packaging.

Returning toFIG. 6, instructions536are included with the sheet500instructing the user on how to apply and use the sheet500as a support system to treat plantar fasciitis. The instructions536instruct the user on how to cut or remove or shape the portion504to conform to the foot, and/or apply the portion504of material in a manner intended to provide anatomical support to the arch of the foot. As shown inFIG. 27, the instructions536may also direct the user to a specific computer internet website700. The website700may provide a set of instructions704for cutting, removing, shaping and/or applying the portion504to the foot. The instructions536may also provide information on, or direct the user to a website700that provides information on, the causes and treatments of plantar fasciitis, and/or heel pain, and/or arch pain. Furthermore, the set of instructions536may contain, or direct the user to a website700that contains, other helpful and commonly known information regarding diagnosing or treating plantar fasciitis, heal pain and arch pain, including such items as stretching or therapeutic exercises, which may be used in combination with the support system of the sheet500. The instructions536may be provided by a printed statement, indicia (such as alphabetical or numerical indicia similar to those shown inFIG. 3), a pattern, a photograph, an illustration, or an outline printed separately with, or directly on, the sheet500or portion504. Alternatively, the instructions536may be provided on a brochure, print advertisement, card, manual, leaflet, or an electronic media storage device (such as a compact disc, digital video disc, memory stick, etc.) included in the packaging or the instructions536may be printed directly on the packaging522as shown inFIG. 8. Alternatively, the instructions536may be provided by any combination of the above.

Furthermore, the instructions536may direct the user to an interactive website700or other media where the user may further learn about the support system504, plantar fasciitis, foot pain, arch pain, heal pain, and treatments and exercises. For example, the website700may provide the user with illustrations, descriptions of symptoms, and provide answers to questions to assist the user in confirming the diagnosis of plantar fasciitis. The website700may have numbered illustrations of the foot or sections of the foot that the user can select to describe the location of the pain. The website700may provide a questionnaire asking about the user's height, weight, age, flexibility, activities and activity level, changes in height or activity level, foot type (high arched, normal arched, flat footed), family history of plantar fasciitis, severity of pain, shoe sizes, shoes types and any number of other topics that will allow the website to advise the user on whether the user has plantar fasciitis and/or other kinds of foot pain or injuries such as a bruised heel, bunion, plantar wart, or any number of other problems. The website700helps the user determine whether the user actually has plantar fasciitis and thus whether the user should use the support system504. People suffering from foot problems other than plantar fasciitis may not benefit from using the support system504.

The interactive process of the website700provides the user with illustrations and instructions to help the user determine whether the user should use the support system504and determine the best size and shape of the support system504for the user to use. The interactive process may further instruct the user as to how to prepare the foot for application of the support system504, such as by shaving or removing hair from the foot and removing oils and lotions from the foot. The interactive process may further instruct the user on the temperature at which to use the support system504and what tension levels are appropriate for use of the support system504. The interactive process may further allow the user to chart and report progress in treating plantar fasciitis and answer questions the user may have during the course of the treatment. The interactive process may also provide methods to ease removal of the support system504.

The website700may also educate the user on the causes of stress on the plantar fascia and the factors which may contribute to plantar fasciitis such that the user may be able to change or alter activities that irritate or damage the plantar fascia. For example, the website700may inform users who climb stairs for exercise that such a practice may contribute to plantar fasciitis and provide ways to alter the user's behavior so as to reduce inflammation of the plantar fascia.

As part of the interactive process, the website700may provide the user with therapeutic exercises or stretches to perform while using the support system504. Stretches which focus on the plantar fascia may be appropriate in later stages of treatment, and the interactive process may recommend exercises to the user at the appropriate point in the user's recovery that will further benefit the recovery. For example, because a biomechanical relationship exists between the calf muscle, the Achilles tendon, and the plantar fascia, the website may recommend exercises to stretch these areas while the user wears the support system such that the stress on the plantar fascia is controlled during stretching. The website700may recommend common calf-stretching exercises that incorporate the use of an angled board, stairs, a block, or a towel while wearing the support system504. Examples of such exercises are described in American Family Physician, Vol. 63, Number 3, pages 469-470, the subject matter of which is incorporated herein by reference.

The interactive process of the website700may also suggest a particular shape or size of the support system504for the user based on the user's particular condition, footwear, or activities. By way of example only, the website700may recommend a support system504having a strapless sole portion502for a woman who wishes to wear open toed shoes. By way of example only, the website700may recommend a support system504having a sole portion502, heel tabs510, a ball strap506and an additional strap (not shown) for the arch of the foot to an overweight user who places a lot of weight to the arch of the foot. By way of example only, the website700may recommend a support system504having no straps across the arch of the foot to a runner that wears good arch-supporting running shoes.

In order to gain access to the interactive website700, the user may be required to log-on with a code that is provided with the support system504. Medical professionals such as doctors who are not the end users of the support system504may be allowed to enter and use the interactive website through separate method of access.

In operation, the user removes a sheet500from the packaging522ofFIG. 8. The user may review the instructions536that come with the sheet500to learn how to apply and use the support system504. The user removes or punches or cuts out the support system504from the sheet500.

Referring toFIG. 10, a support system504has been removed from the sheet500. A release liner516is separated or perforated into a sole section542, strap sections546, and a tab section550such that different sections of the release liner516may be removed from the support system504as necessary. Alternatively, the release liner516may have any number of sections as necessary to accommodate the shape and use of the support system504. After removing the support system504from the sheet500, the user may further cut and form the support system504as necessary for application. For example, the user may trim the heel tab510such that the heel tab510better fits the user's foot.

Referring toFIGS. 11-14, a support system504is applied to a foot540or a portion of the foot540. The user peels the tab section550(FIG. 10) of the release liner516(FIG. 7) from the heel tab510of the support system504and applies the heel tab510of the support layer508to the heel554of the user's foot540such that the adhesive layer512(FIG. 7) is affixed to the skin of the user's heel554and retains the support layer508to the heel554. The user then peels the sole section542of the release liner516from the sole portion502of the support system504and adhesively applies the sole section542of the support layer508to the sole558of the user's foot540. The sole portion502should be positioned about the sole558of the foot540from the bottom566of the heel554along a longitudinal axis570axis of the foot540to the ball574of the foot540. The user then peels the strap sections546of the release liner516from the ball strap506of the support system504and adhesively applies the ball strap506of the support layer508transversely to the longitudinal axis570of the foot540across the sole558of the foot540about the sides560and top562of the user's foot540to secure the sole portion502about the sole558. Thus, the multiple sections of the release liner516allow the user to use the heel tab510as an anchoring connection to the foot540such that the sole section542and the ball strap506may be more easily aligned and affixed to the foot540than if the entire support layer508was applied to the foot540at once. The user may remove and re-apply or adjust the support layer508on the foot540to obtain a better placement. Once the support layer508has been secured to the foot540as shown inFIGS. 11-14, the support layer508may be worn all day long and changed on a daily basis. The support system504may be used continuously or on a periodic basis as needed. Once each support layer508has been used, the user removes and disposes of the support layer508and reapplies a new support layer508. The support layer508may be used with orthotic practices, physical therapy, and other treatment modalities to treat plantar fasciitis and other foot pain.

Alternatively, the support system may have any number of different configurations for use with a foot. Referring toFIG. 15, a support system804includes an additional arch strap578having first and second ends582and586extending transversely from the sole portion502.FIGS. 16-18illustrate multiple views of the support system804ofFIG. 15applied to a foot540. The support system804is applied to the foot540in generally the same manner as the support system ofFIGS. 11-14. However, the user also adhesively applies the arch strap578of the support layer508transversely to the longitudinal axis570and arch590of the foot540across the sole558of the foot540and about the sides560and top562of the user's foot540such that the first and second ends582and586may or may not overlap and are adhesively connected at the top562of the user's foot540. The embodiment of the support system804with the arch strap578provides additional support along the arch590of the foot540.

Referring toFIG. 19, a support system904may include a strapless sole portion502that is adhesively applied to the entire sole558of the foot540from the bottom566of the heel554along the longitudinal axis570axis of the foot540to the ball574of the foot540. Alternatively, the sole portion502may only cover a portion of the sole558. Because the support system904does not include any straps, users may discretely wear the support system904with shoes that reveal the top and sides of the user's foot, such as sandals or other open shoes.

Alternatively, as shown inFIG. 20, the support system940may include separate portions that can be removed from the sheet500. The support system940includes the sole portion502with heel tabs510, the ball strap506, and the arch strap578, each of which can be removed separately from the sheet500for application to the foot540. For example, the user may apply the sole portion502first, and then apply either or both of the ball strap506and the arch strap578as the user sees fit. Alternatively, the user may only apply one of the sole portion502, the ball strap506or the arch strap578, or any combination thereof. Thus, the embodiment ofFIG. 20offers the user more flexibility in tailoring the treatment to the user's specific needs for treating pain while limiting the visibility of the support system940.

Alternatively, the support system may include a single strap that the user can use in combination with orthotic practices to address specific pain problems. The strap may be sized and shaped to address the particular areas of the user's foot that need treatment.FIGS. 21 and 22illustrate opposite side views of a strap594applied to a foot540. The single strap594may be applied to the foot540transversely to the arch590and longitudinal axis570of the foot540from ankle598to ankle602. The strap594provides constant pressure along the arch590of the foot540to reduce inflammation and thus reduces pain. The strap594may be worn at night when the user sleeps. Alternatively, as shown inFIG. 23, the strap594may include a support strap606configured to hold the strap594about the ankles598and602. By way of example only, the support strap606may be retained about the leg610by adhesive, elastic, or Velcro.

FIG. 24illustrates a top view of a diamond-shaped strap614that may be provided on a sheet500as part of a support system according to an embodiment of the present invention. As shown inFIG. 25, the strap614may be applied to the foot540transversely to the longitudinal axis570and arch590of the foot540across the sole558of the foot540and about the sides560and top562of the user's foot540like the arch strap578ofFIG. 15. The strap614anatomically supports the medial arch of the foot540instead of specifically to the longitudinal arch.

FIG. 26illustrates a top view of the support system980in accordance with an embodiment of the present invention. The support system504includes holes618along the ball strap506and heel tabs510and slots622and a tear-shaped aperture626along the sole portion502. Alternatively, the support system980may include any number of apertures having other shapes. Alternatively, the support system504may have at least one of, or any combination of, the holes618, slots622and aperture626at any other locations thereon. The holes618, slots622, and aperture626are provided to alter the stretch resistant properties of the support system980, focus or transfer the stress carried by the support system980, or aid in preventing direct application of pressure to inflamed areas of the foot when the support layer508of the support system980is applied to the user's foot. Also, the holes618, slots622, and aperture626allow the skin from the foot to breathe and allow the skin to contact surfaces in order to reduce the possibility of the user slipping while wearing the support system980. Additionally, the holes618, slots622, and aperture6226, may be ornamental. The holes618, slots622, and aperture626may be pre-cut into the support system980or may be created by the user.

Like the support system400ofFIG. 3, the foot support kit serves to restrict extension of the tissue on the bottom of the foot and thus the level of tensile stress on the plantar fascia to reduce foot pain, arch pain, and heel pain, and to rehabilitate the plantar fascia, and to prevent injury to the plantar fascia. The stretch resistant properties of the support layer508share the stresses normally absorbed by the plantar fascia alone. The support layer508manages foot pain and addresses the cause of plantar fasciitis by controlling and limiting the stress on the plantar fascia and surrounding tissues across both the medial and longitudinal arches and thus minimizes tears in the plantar fascia.

The stretch resistant plantar fascia support system of the different embodiments may be used while sleeping, while walking around with barefeet, or while wearing various types of footwear. Also, the stretch resistant plantar fascia support system non-invasively reduces the level of tensile stress carried by the plantar fascia and may prevent the need for complex and expensive surgery.

For example, a consumer may wake-up in the morning and experience pain along the bottom of the consumer's foot. The consumer may recognize the pain as plantar fasciitis and desire to treat the pain. Rather than schedule an appointment with a doctor and have to travel to the doctor's office for treatment, during which time the plantar fascia may be subjected to further excessive tensile stress, the consumer may desire to treat the pain at home.

With the stretch resistant plantar fascia support system of the present invention, the consumer may save the time, expense, and pain of traveling to a doctor's office for treatment. To use the stretch resistant plantar fascia support system, the consumer would simply remove the removable protective covers that protect the adhesive layer and apply the stretch resistant plantar fascia support system to the affected area.

While the above scenario described the consumer applying the stretch resistant plantar fascia support after waking up in the morning, the stretch resistant plantar fascia support system may also be worn to bed at night. By wearing the stretch resistant plantar fascia support system to bed at night, the stretch resistant plantar fascia support system may aid in the healing process while the consumer sleeps and protects the plantar fascia during the first few steps in the morning when stress is re-applied.

In addition, the stretch resistant plantar fascia support system may be comfortably worn when the consumer is not currently experiencing pain, but anticipates the potential for injury during a strenuous activity. For example, a consumer with a history of frequent occurrences of plantar fasciitis may desire to return to a strict exercise regiment following a prolonged period of inactivity. To avoid overstressing the plantar fascia until the foot has had enough time to become re-accustomed to the stresses of exercise, the consumer may desire to use the easily applied stretch resistant plantar fascia support system rather than some of the more cumbersome, less effective, and inconvenient alternatives such as taping and molded arch supports.

To aid the consumer with installation of the stretch resistant plantar fascia support system, the removable protective covers, or other portions of the stretch resistant plantar fascia support system, may include numerical indicia that indicate the order in which portions of the stretch resistant plantar fascia support system are applied to the foot. The consumer then applies the stretch resistant plantar fascia support system to the consumer's foot in the prescribed order.

In addition, the stretch resistant plantar fascia support system is comfortable and form fitting. The stretch resistant plantar fascia support system may be supplied for a plurality of foot sizes and the consumer may select the stretch resistant plantar fascia support system much like shoes are selected based upon standard shoe sizes. The foot sole support of the stretch resistant plantar fascia support system may even be shaped to conform to the shape of the sole of a foot. If an adjustment is needed to adapt the stretch resistant plantar fascia support system to an irregularity in a particular consumer's foot, the stretch resistant plantar fascia support system may be easily adapted by cutting the stretch resistant plantar fascia support system to accommodate the irregularity.

Because the stretch resistant plantar fascia support system is form fitting, the consumer may wear the stretch resistant plantar fascia support system in a variety of situations. For example, if a woven rayon microfiber with a 3600 thread count and/or thickness less than 30 mils, or alternatively less than 15 mils, is used, then the stretch resistant plantar fascia support system is thin enough to comply with contours of the foot and strong enough to provide adequate strength. While the consumer has the stretch resistant plantar fascia support system attached to the consumer's foot, the consumer has the option of walking around in bare feet, pulling a sock over the foot, or putting on shoes. The consumer may also wear the stretch resistant plantar fascia support system while using other additional devices such as arch supports, night splints, and custom orthotics.

Also, the stretch resistant plantar fascia support system does not interfere with rotation and movement of the ankle or calves. The stretch resistant plantar fascia support system is positioned beneath the ankle. The heel straps and the heel strap tabs are sized to avoid interference with the ankle bone. Because the stretch resistant plantar fascia support system is positioned beneath the ankle, contact between adhesive and leg hair is reduced. Thus, the need for shaving portions of the leg and ankle is reduced.

Also, different embodiments of the stretch resistant plantar fascia support system may be used depending on the type of footwear the consumer desires to wear while the stretch resistant plantar fascia support system is attached. For example, if the consumer is going to wear sandals, the consumer may desire to use a stretch resistant plantar fascia support system with a foot sole support and no adhesive straps or tabs to reduce the visibility of the stretch resistant plantar fascia support system. On the other hand, the consumer may desire to wear boots, where visibility of the stretch resistant plantar fascia support system is not an issue, and the consumer desires to have straps and tabs along with the foot sole portion for added stability.

The present invention may also include other items that can benefit a user. For example, to minimize the potential for skin damage and foot odor from the presence of moisture, the stretch resistant plantar fascia support system may be made of a permeable material. The stretch resistant plantar fascia support system may be made of a permeable material that wicks moisture away from the skin or the stretch resistant plantar fascia support system may include holes in the material to allow for the evaporation of moisture. In conjunction with the permeable material, adhesive may be applied in an intermittent manner to further increase the permeability and reduce the presence of moisture trapped between the foot and the stretch resistant plantar fascia support system. Also, the stretch resistant plantar fascia support system may include additives such as medicines, anti-fungal treatments, anti-microbial treatments, anti-inflammatory treatments, cooling compounds, heating compounds, deodorants, zeolite, perfumes, moisturizers, tee tree oil, talcum powder, and zinc oxide.

Thus, the present invention provides an effective system for the treatment of plantar fasciitis that is both economical and easy to use. The present invention provides a stretch resistant system that may be discretely attached to a patient's foot and reduces stress on the plantar fascia.