WO2007111922A2 - Adjustable pneumatic cell foot orthosis - Google Patents

Abstract

A device that can be inserted into footwear, or used as part of footwear that is designed to correct foot and ankle pathologies through user adjustable, strategically located fluid chamber or chambers.

Description

Adjustable Pneumatic Cell Foot Orthosis

Background of the Invention

Prior orthopedic devices have been developed for the purpose of applying supportive or corrective pressure to a foot, or for the purpose of cushioning or making space for ("accommodating") existing foot deformities. One form of such devices, collectively referred to as foot orthoses (singular, "orthotic device"), consist of molded, laminated, carved, or otherwise laminated materials placed under the foot. These devices use relatively static means of pressure application by applying a constant corrective ground reaction force that may only be adjusted by adding or subtracting material beneath the foot. The user must then adapt to these constant forces.

Numerous pathologies of the foot, ankle, and other parts of the body can be partially or completely alleviated with foot orthotic devices. These diseases and disorders include, but are not limited to: flat feet, fallen arches, painful feet, metatarsalgia, high arches, low arches, tendonitis, corns and calluses, neuroma, neuropathy, skin conditions, impingement syndromes, fasciitis, malalignment, stress fractures, bursitis, arthritis, ulcers, knee pain, hip pain, back pain, and arch fatigue.

Unlike prior art, which relies on passive, static cushioning and support, the present device is a dynamic foot orthotic device that utilizes one or more adjustable contoured pneumatic cells or group(s) of cells for the purpose of providing more supportive and corrective measures, variable and interactive support and/or corrective pressure. Our device is a prefabricated off-the-shelf foot orthosis, customizable instantaneously by the wearer. It does not require a skilled practitioner or complex tools or instruments or procedures to perform modifications. As such our invention bridges the two main categories of foot orthotics, prefabricated/mass produced while individually customizable.

The present device incorporates one or more robust air chambers that treat and/or correct medical conditions of the foot. The device is unlike one group of inflatable "insoles" where the inventors use a connected set of air cells to cushion the foot using padding to provide support. The way in which this invention inflates the insole would render it difficult to provide the corrective action required to address foot pathologies. These "insoles" would more provide comfort rather than corrective action. Essentially these insoles serve to cushion, reduce shear and provide comfort through a mechanism analogous to walking on a balloon, rather than providing stability and corrective action. U.S. Patent Nos. 6,976,321; 5,025,575; 5,846,063; and 6,510,624.

For many years there has been considerable interest and activity with respect to foot orthoses/orthotics. According to the International Organization for Standardization (ISO Standard 8549-1; 1989-07-01:1-6) the word 'orthotics' refers to the general category of external mechanical devices worn by a person to affect the structure and/or function of an existing body part. Orthotic devises are further divided into smaller categories named according to the anatomic joints they bridge. Therefore, foot orthoses cross the intrinsic joints of the foot and affect foot structure and/or function.

Many orthopedic diseases and disorders are treated with orthotic devises. These diseases and disorders include, but are not limited to: flat feet, fallen arches, painful feet, metatarsalgia, high arches, low arches, tendonitis, corns and calluses, neuroma, neuropathy, skin conditions, impingement syndromes, fasciitis, malalignment, stress fractures, bursitis, arthritis, ulcers, and arch fatigue, knee pain, hip pain, and back pain.

Many braces and orthotics have been developed over the past thirty years for the treatment of such disorders. Foot orthoses can be divided into two main categories: custom and non-custom. Non-custom devices are pre-fabricated devices that are mass manufactured in limited shapes and sizes. Meanwhile, custom devises are individually made from a mold, imprint, or cast of a person's foot (using foam or plaster or another material). The resulting device accordingly conforms much more closely to the foot.

The ongoing problem with the current state of the art for foot orthoses is as follows: Non-custom, pre-fabricated devices do not allow customization to the shape of a person's foot. For instance, see U.S. Pat. Nos. 6,393,736, 4,628,936, 7,120,958, and 5,400,528. .

Meanwhile, custom devises are not pre-fabricated and require the entire device to be individually constructed to contour to an individual's foot. For instance, see U.S. Pat Nos. 4,360,027 and 5,058,585.

Some inventions, U.S. Pat Nos 5,345,701, 6393736, bridges these categories, and while pre-fabricated can be customized to the shape of a person's foot. However, unlike the current invention, these devices use interchangeable solid posts and wedges to obtain correction, rather than air chambers.

Similarly, the devices claimed by McCracken et al. in U.S. Patents 6,804,902 and 6,966,131 are prefabricated but do allow a user to adjust angles of the arch curve and to set tension along the arch curve. This is accomplished, however, with a tensioning device that uses straps, brackets, and other solid members. Similarly, US Patent 5,903,985 uses other solid mechanisms to adjust the arch support.

One related but intrinsically and inherently different device is claimed in U.S. Pat 6,510,624, "an inflatable lining for footwear with protective and comfortable coatings or surrounds." This device is designed as an insole for a shoe, rather than being a corrective device to affect structure and function. The inflatable chambers of this device span the entire insole, and as such, cannot treat in a corrective manner mechanical deformity and the other conditions described above. Essentially, this insole and others (U.S. Pat Nos 4,183,156; 4,340,626; 4,817,304; and 5,846,063) serve to cushion and reduce shear through a mechanism analogous to walking on a gas- or fluid-filled balloon.

Another intrinsically and inherently different devise is claimed in U.S. Pat 6,976,321, an "adjustable air cushion insole with additional upper chamber."

As the inventor of this device points out, this device "generally relates to an inflatable lining for footwear, and specifically to an inflatable inner sole with protective and comfortable coatings and surrounds and a method of manufacture." It incorporates an upper and lower air chambers as described in U.S. Pat 6,510,624, but unlike our invention is again designed as an insole for a shoe, rather than being a corrective device to affect structure and function. The inflatable chambers of this devise span the entire insole, and as such, cannot treat in a corrective manner mechanical deformity.

Unlike the prior art of U.S. Pat 6,976,321, which specifically allows changing contour and is designed to allow "free air/fluid flow from pressure point areas to areas of least resistance and greatest need," our device controls the structure of the foot by directly lifting or unloading a portion of the foot using one or two robust air chambers. In our device there is no dynamic flow from a pressure point area to a low-pressure area. Such flow is structurally counter-intuitive for those medical conditions listed above. Our device is instead structural and maintains a more constant pressure and contour.

Summary of the Invention

It is an objective of this invention to provide an device that targets corrective action toward variable foot pathologies.

It is another objective of this invention that the device is both inexpensive and readily available to the user.

It is yet another objective of this invention to provide the wearer the ability to adjust the position of the chambers in the orthotic to fine-tune the corrective action.

It is still another objective of this invention to provide the wearer the ability to adjust the pressure in each individual chamber according to the corrective action required.

It is also an objective of this invention to provide corrective action for foot pathologies such as, but not limited to, arthritis, tendonitis, tendinosis, metatarsalgia, callosities, ulcer, neuroma, fat pad atrophy, flatfoot, foot deformity, plantar fasciitis, bone spurs, knee pain, hip pain, and back pain.

Brief Description of the Drawings

Figure 1 schematically illustrates various illustrative positions where the air chambers may be positioned.

Figure 2 schematically illustrates a second potential embodiment wherein: (1) the metatarsal pneumatic cell is contiguous, but the cell is thicker either on the lateral side (1) or the cell could be thicker on the medial side (2). This second embodiment may also hold true for the heel pad wherein one pad may be thicker on the medial side (4) or the heel pad may be thicker on the medial side (5) depending on where correction is required. The arch pneumatic cell (3) may be different sizes and shapes to accommodate variances in the population.

Figure 3 schematically illustrates a embodiment wherein: (1) the metatarsal chamber is more circular or oval shaped (as opposed to that of Figure 1) and is more centrally located just proximal to (or behind) the metatarsal heads.

Figure 4: This figure shows one potential embodiment of a representative air chamber location within the orthotic.

Figure 5 schematically illustrates a embodiment of a representative air chamber located on top of a bottom layer.

Figure 6 schematically illustrates a yet another embodiment of the location of a representative air chamber placed underneath of a top layer.

Description of the Preferred Embodiments

Among the many benefits of the present device, it can alleviate symptoms caused by pathological conditions and deformities of the foot and ankle using a dynamic adjustable pneumatic cell system to cushion, support, and/or deliver corrective pressure to the foot. Heretofore, foot orthoses have been made of static molded, carved, laminated, fluid-filled, or solid materials placed under the foot. The present device utilizes adjustable pneumatic chambers for the additional benefits of enhanced cushioning, variable and interactive support, and/or corrective pressure. The amount of cushioning, support, or corrective pressure delivered by the present device may be adjusted without having to remove or detach anything. Adjustments may be done through overlying clothing (pants, sock, shoe) and an increase or decrease in the amount of air in the cells can be instantaneously felt by the user. The optimal setting can thus be arrived at immediately. As the user's tolerance for corrective pressure increases or decreases, immediate adjustment can be made. Thus, the user may adjust the. amount of corrective pressure, standing or sitting, with or without removing the device, and may also possibly adjust the position of the corrective cell(s) when the device is removed.

Further, the present device forms an adjustable, self-contained device that provides support of the foot and ankle in multiple planes. The device provides support for hindfoot-forefoot relationships in the transverse and sagittal planes, and support for the relative rotational positions of the hindfoot to forefoot along the long axis of the foot. This device uses a pneumatic cell system to achieve such support throughout the entire stance phase of the gait cycle. Unlike prior art, the present device also achieves such support without removal, re-molding, or re-modeling.

Furthermore, the device specifically addresses plantar foot and heel pain caused by conditions or anomalies of the plantar arch and heel venous plexus. To this end our device permits pneumatic compression of the venous plexus and may additionally provide intermittent pulsations to stimulate proper blood and extra cellular fluid flow.

A first embodiment of our invention consists of a compressible air chamber or bulb that can be detached from or fixed to (permanently or in other relatively secure manner) the device. The bulb communicates with one or more of the air cells. The air cell(s) may individually, in some combination, or as a group be inflated by compressing the air chamber. Excessive pressure within the air cell(s) may be released by opening a pressure release valve. In this way, the person's capacity to tolerate corrective pressure is utilized fully. The person's ability to tolerate pressure is usually the constraining element in an orthotic system; therefore, it is the optimal utilization of that tolerance that helps optimize the whole system. In addition, the present orthotic device also facilitates progressive desensitization of the area where corrective pressure is applied, thereby allowing increased system performance over time as well as at any immediate moment. Adjustments to facilitate the optimal utilization of a wearer's capacity for pressure tolerance, and adjustments to facilitate progressive change in that tolerance over time would have required multiple visits to a skilled orthotist with prior devices. The present device allows these adjustments to be made by the user without such visits.

Another advantage of the present invention is that, in certain preferred embodiments, it will allow user adjustment of the position of the air cell(s). The cell(s) may be attached to a supporting structure by a means that allows repositioning, such as Velcro or hook and loop fasteners. The patient can change the position of the cell in response to the comfort or discomfort that he or she feels and the exact area may be altered to optimize cushioning and/or corrective support and minimize irritation in each individual case. As the user's sensitivity changes, further adjustments may be made to the exact position of the corrective cell.

The heel cell(s) in the second embodiment may also advantageously contain resilient material that causes the cell(s) to expand whenever the user is not bearing weight on the heel of the involved foot. This expansion causes an intake of air into the heel cell. For example, a second one-way valve may be used to allow air intake but prevents air escape through an intake port. The air chamber and release valve are preferably positioned so that the user does not have to disconnect or remove any part of the orthotic device or clothing to make adjustments. This assembly can enable the user, by only one adjustment, to control the amount of corrective pressure applied. If the corrective air cell is positioned properly, it will provide corrective pressure plantarly, medially, and along oblique lines between the cardinal planes. .

A third embodiment includes both of the first two embodiments. Two means of inflating the cell(s) are provided, including a bulb securely attached to the orthotic device which may be operated by hand, and a cell positioned beneath the heel which is operated by normal, intermittent weight bearing. This assembly allows immediate feedback concerning increases in air pressure in the mid-foot air cell, without having to walk a few steps to cause the pressure increase. This assembly would also allow the use of a single adjustment modality to control the amount of corrective pressure, if the user preferred.

Another embodiment of the invention consists of a compressible air chamber or bulb fixed (permanently or in other relatively secure manner) to the orthotic device, and a cell positioned under the heel. This assembly allows immediate feedback concerning increases in air pressure in the mid-foot air cell, without having to walk a few steps to cause the pressure increase. This assembly also permits the use of a singe adjustment modality to control the amount of corrective pressure, if the user preferred.

Yet another embodiment incorporates some or all of the above embodiments into a sock, rather than an orthotic device.

Still another embodiment includes some or all of the above embodiments in a shoe, rather than an orthotic device, hi this version using a shoe, there are various additional controls available on the outside of the shoe that allow the user to open and close one-way valves, two-way valves, release valves, and chambers. Again, to provide the optimal corrective action required by the wearer.

Of course, one skilled in the art will appreciate how a variety of alternatives are possible for the individual elements, and their arrangement, described above, while still falling within the spirit of my invention. Thus, for example, there are other means for providing compressed gas besides a bulb or chamber, including a compressed gas cylinder. While the inflatable cells may be any commercially available, such as those made by Aircast, other inflatable or expandable structures, useful in generating controlled pressure. While a single one way valve is preferred, multiple valves may be used to separately control separate cells, either at the infill or in letting off pressure. The fill valve may also serve as a pressure relief valve, or a separate valve(s) maybe used. Examples of suitable valve mechanisms include plug valve, ball valve, stop valve, globe valve, check valve, gate valve, butterfly valve, and spring-loaded pressure relief valve. The possible mechanisms for holding the cells in place on the device include hook and loop fasteners, adhesives, mechanical fasteners, magnets, welding, imbedding processes and any other secure fastening means. The midfoot cell that applies corrective pressure is best fastened by a means that allows occasional repositioning by the user, such as, but not limited to, hook and loop fasteners.

External, mechanical treatments are known to reduce positional deformity and excessive connective tissue stress, when applied in the early stages of foot and ankle deformities. Such treatment can prevent or slow the progression of deformities. The mechanically optimal site to apply corrective pressure is likely to be irritated as a result of pain and inflammation. At the same time, when the foot/ankle structures are maintained closer to their normal position, comfort is likely to be increased. Because of these and other variable characteristics of the affected person's anatomy and sensitivity, the person's ability to tolerate corrective pressure is likely to change during the time a corrective mechanical device is worn. The advantages of the present device are that it provides a means for the user to readily adjust and optimize the amount and location of corrective pressure in immediate response to the comfort or discomfort felt at any given moment, not just when initially fitting the device.

Referring now to Figures. 1 & 2, the invention as applied to. an device will be described. Figures. 1 and 2 show independent chambers on a diagram of a foot. This is for illustrative purposes; the actual orthotic consists of a base or bottom layer suitable for an orthotic and a cover or top layer, both in the shape of the sole of a shoe or other footwear. The inflatable chambers would be either temporarily or permanently secured between these two layers or could be secured to the top of the bottom layer.

Figure 1 illustrates one potential embodiment of foot orthotic wherein air cells are positioned under: a) the heel, b) medial arch, and c) forefoot, (1) Medial metatarsal pneumatic chamber, (2) Lateral metatarsal pneumatic chamber, (3) Arch or midfoot pneumatic chamber, (4) Medial heel pneumatic chamber, (5) Lateral heel pneumatic • chamber. An approximate shape of one embodiment of said shape is shown adjacent to the diagram of the foot in Figure. 1 ; this approximate shape is shown as a mirror image of the foot. The inflatable chambers in Figure 1 are shown placed in key areas to target corrective action for various foot pathologies. Numbers 1 and 2 in Figure. 1 would address metatarsal pathologies such as metatarsalgia. This chamber can be crescent shaped as shown in 1 and 2 of Figure 1 or it can be more circular or oval in shape as shown in number 1 of Figure 3. It will be positioned just behind or proximal to the metatarsals and the width can be varied to address specific pathologies. As shown in Figure 1, numbers 1 and 2 can be two independent chambers (lateral and medial respectively) and inflated/adjusted according to the wearers' needs. Additionally, as shown in Figure 2, areas 1 and 2 could be one independent chamber that is higher or thicker on either the medial side (2) or on the lateral side (1) of the foot, depending on the corrective action needed.

Number 3 of Figure 1 is an arch or medial midfoot support located along the medial midfoot region and in one preferred embodiment extends from just proximal (or behind) the medial metatarsals to just distal to the calcaneus (or heel bone) and may extend laterally to encompass a portion or the entire width of the foot. This corrective chamber is meant to target pathologies such as tibialis posterior tendon dysfunction and pes planus (flatfoot) deformities and related pathologies. Again referring to Figure. 1 and looking at numbers 4 and 5 one can see that these two chambers are meant to target alignment of the hindfoot and thus address such pathologies. The chambers 4 and 5, as shown in Figure. 1 are two independent and separately inflatable chambers and can be adjusted accordingly by the wearers' corrective needs.

Another configuration of the hindfoot chamber is shown in Figure 2, numbers 4 and 5. In this Figure 2 it is seen that the hindfoot chamber is a single chamber and, similar to the single metatarsal pad in Figure 2., can be thicker either on the medial side (4) or on the lateral side (5) of the foot, depending on the corrective action required by the wearer. If a varus (or inward) tilt is required then a chamber with a thicker medial side will be utilized to raise the medial aspect of the hindfoot. Similarly, if a valgus (or outward) tilt is required, a chamber with a thicker lateral side would be utilized to raise the lateral aspect of the hindfoot.

Figure 4, numbers 6 and 7: number 7 is a bottom layer constructed of suitable material for a corrective orthotic. This material could be a polymeric material such as graphite epoxy or a natural material such as cork. Above or on top of the bottom layer (7) are located the inflatable chambers. In this Figure only number 3, the arch corrective support or mid-foot chamber is shown for simplicity. In a preferred embodiment a top layer, number 6, would be placed and formed to the inflatable chambers. This material could be fabric, or leather, or other suitable material such as to be durable and to provide comfort to the wearer. The top layer (6) and bottom layer (7) would preferably be bonded together using a suitable adhesive with the appropriate air chamber in place. A second embodiment would be to bond the upper layer (6) and bottom layer (7) together while leaving an open pocket in the areas of the metatarsals (1) and/or (2), the arch/midfoot (3), and/or the heel area (4) and (5). ■

Figure 5 illustrates another embodiment for the orthotic device in accordance with the present invention. In Figure 5, the device_.comprises a bottom layer (7) with the air chamber located on top of said bottom layer. Only the arch corrective support (3) is shown for simplicity.

Figure 6 illustrates a further embodiment for the orthotic device in accordance with the present invention. In Figure 6, the device comprises a top layer (6) with the air chamber located underneath of said top layer. Again, only the corrective arch support chamber (3) is shown for simplicity.

Claims

1. An orthotic device including one or more chambers structured to minimize fluid connection between the chambers.

2. The device of claim 1 further including a system pockets for the chambers comprising hook and loop positioned to allow adjustment of the position of the air chambers within the dimension of the orthosis.

3. The device of claim 1 wherein the chambers are permanently secured above a bottom layer, below a top layer or sandwiched between a bottom and top layer.

4. The device of claim 1 wherein the chambers are temporarily secured in pockets of variable sizes in a bottom layer, in a top layer, or between a top and bottom layer, so as to allow the chambers to be repositioned by the wearer.

5. The device of claim 1 wherein at least one of said chambers is independently filled or exhausted.

6. The device of claim 1 wherein a span or extension of said chambers is less than across the entire dimension of the orthotic, and wherein said chambers are positioned based on a medical condition being treated.

7. The device of claim 1 wherein said chambers do not simultaneously span high pressure and low pressure areas, and wherein said chambers are positioned to support and maintain pressure and contour in strategic mechanical position based on a medical condition being treated.

8. The device of claim 1 wherein said chambers are structured and arranged to correct and treat medical conditions of the foot by providing realignment and support of the foot and ankle in multiple planes.

9. The device of claim 1 being structured and arranged to be a removable corrective or accommodative orthosis rather than a cushioned shoe insole.

10. The device of claim 1 including chambers structured and arranged to corrective provide correction for orthosis for medical conditions rather than a cushioning, comforting insole, wherein the medical conditions include: flat feet, fallen arches, painful feet, metatarsalgia, high arches, low arches, tendonitis, corns and calluses, neuroma, neuropathy, skin conditions, impingement syndromes, fasciitis, malalignment, stress fractures, bursitis, arthritis, ulcers, knee pain, hip pain, and back pain, and arch fatigue.

11. The device of claim 1 being structured and arranged to provide at least one of correction and accommodation by including one or more individual chambers that are not in substantial fluid communication so as to target certain regions of the foot and thereby specific pathologic conditions.

12. The device of claim 1 wherein the chambers are structured to minimize fluid flow from one chamber to another.

13. The device of claim 1 wherein there is one or more singular self-contained fluid - filled or fluid filled chambers, rather than an interconnected plurality of fluid flow chambers.

14. The device of claim 1 including at least one inflatable, adjustable, corrective and supportive fluid chamber structured to allow manual customization of the volume of said chamber.

15. The device of claim 1 wherein the chambers are permanently secured above a bottom layer, below a top layer or sandwiched between a bottom and top layer.

16. The device of claim 1 wherein the chambers are temporarily secured in pockets of variable sizes in a bottom layer, in a top layer, or between a top and bottom layer, thus allowing the chambers to be repositioned by the wearer.

17. The device of claim 1 being a corrective or accommodative medical orthotic system using one or more individual chambers but not interconnected chambers to target certain regions of the foot and thereby specific pathologic conditions.