The current invention provides a load distribution device that supplements orthotic attachment systems. The load distribution device is particularly effective at distributing and redirecting the detrimental forces associated with, for example, dynamic orthoses, thereby minimizing migration, increasing wearer comfort, and improving the efficacy of the orthosis.
Solutions for orthosis migration have been proposed with varying success. Most involve enhancing the friction between the straps or attachment system and the wearer's leg either by increasing the contact area, increasing the tension of the strap, increasing the coefficient of friction between the strap or connector and the wearer, or combinations thereof.
For example, anti-migration straps for a knee brace are described in the art. The straps described are flexible and may be made or coated with a high-friction material. In some versions it is recommended that the anti-migration strap is disposed over the widest portion of the wearer's calf. Such an anti-migration device does not redirect the forces that lead to migration but instead uses friction to withstand them, which is therefore unlike the current invention.
Another example known in the art is an anti-migration wrap that is secured to an orthotic strap made from a flexible material, such as a breathable foam with high friction properties. The wrap may be made from a unitary material or combinations of materials such as a core of foam, and skinned with a high friction material. Like the previous example, this solution uses friction to withstand the anti-migration forces, but does not redirect the forces; again, it is therefore unlike the current invention.
Similarly, it is known to use under-wraps or sleeves to help secure strapping or attachment systems to limbs. The sleeves fit tightly to the limb and offer a large surface area to help withstand migration forces. By selecting the right material for the outer surface of the sleeve they can help prevent the migration of the orthotic straps. Sleeves, however, may be uncomfortable, difficult to don or doff, and are not appropriate to be worn over clothing.
Examples of specialized solutions such as buttressing or protrusions also exist but these are specific to braces or body geometries (e.g., a buttress for an ankle foot orthotic) and are not general solutions to the problem of strap migration.
Anti-migration and redirecting attachment system forces are important for all types of orthoses but are even more difficult to achieve simultaneously for dynamic orthoses. The forces required for therapeutic manipulation of the body part can be quite high. A brace as described herein can produce 40 lbs. of unloading force; a heavy-duty brace as described herein can produce an even greater unloading force. However, the same beneficial forces that are needed for therapeutic manipulation also have the undesired effect of moving/migrating the orthotic out of proper position on the wearer and making it uncomfortable to wear.
Therefore, an improved load distribution device with attachment system is needed that can effectively distribute therapeutic manipulation forces without compromising security, convenience, and comfort of the underlying orthotic and its attachment system.
Examples of references related to this art include the following U.S. patents and patent applications: U.S. Pat. Nos. 9,265,642; 10,285,842; 10,702,409; 10,786,381; 10,806,620; 11,096,816; 7,850,632; 11,253,384; U.S. Publication No. 20200000620A; U.S. Pat. No. 7,918,812; U.S. Publication No. 20120065562A; and U.S. Pat. No. 5,554,104.
In general, orthotics can be divided into three categories: immobilizing, stabilizing, and dynamic. An immobilizing orthotic, such as a sling or a splint, holds the limb or body part in a fixed position. (The phrases body part, limb, and body element are used interchangeably herein.) The purpose of an immobilizing orthotic is to prevent injury and/or aid in healing by keeping the muscles, joints, and bones in a specific position-either to align various components (e.g., the ends of a fractured bone), or to prevent motion of damaged components (e.g., a severe muscle strain).
Stabilizing orthotics allow some motion of the affected joint or limb, but they protect the joint from unwanted range of motion. For example, a knee orthotic can be used to provide lateral stability of the knee while allowing full freedom of flexion/extension motion. Another example of a stabilizing orthotic is an elbow brace used to prevent hyper extension of the elbow while allowing normal range of motion of the joint.
The third type of orthotic is a dynamic orthotic. These orthoses are used to manipulate a limb or body part therapeutically by applying specific force vectors. Dynamic orthoses can be used to reduce pain or improve function. For example, an unloading knee brace, such as the Ascender™ sold by Icarus Medical Innovations of Charlottesville, Va., imparts forces to the wearer's thigh and calf that reduce the applied forces on the wearer's patella femoral joint as described in U.S. Pat. No. 10,806,619, and incorporated herein by reference in its entirety. Immobilizing and stabilizing braces dominate the bracing market, with dynamic bracing representing only a small fraction, in part because it is a newly developed technology. In a dynamic brace, much higher forces are generated over a small surface area. Available strapping or attachment technology used for immobilizing and stabilizing braces are currently unsuitable or have not yet been developed, and therefore, not readily adaptable to dynamic orthosis that require higher load distribution, and possible direction of force. The problems are in whole or in part resolved or improved upon by the invention described herein.
All three types of orthotics need to be secured to the wearer's body to work as intended. Orthosis attachment systems include, but are not limited to, straps, webbing, pads, belts, laces, cords, sleeves, cuffs, slings, elastics, buckles, stops, clips, rings, and the like, which are common methods of/mechanisms for securing orthoses/orthotic braces. Therefore, the various kinds and combinations of orthosis attachment mechanisms/means such as straps, webbing, buckles, stops, etc. used to secure an orthotic to the wearer, as noted above and herein, will be henceforth referred to in aggregate as attachment system, strapping system, or orthosis attachment system. Consequently, the term orthosis attachment system(s) and attachment system(s) include but are not limited to mechanisms for attaching an orthosis to a wearer, such as straps, webbing, pads, belts, laces, cords, sleeves, cuffs, slings, elastics, buckles, stops, clips, rings, straps, or combinations thereof.
Orthosis attachment systems should be secure (for example, resist sliding out of place on the limb to which they are affixed), convenient (for example, easy to don and doff), and comfortable (for example, not cause chafing). These three attributes are somewhat contradictory. Tightening an orthosis attachment system sufficiently to prevent the orthotic from sliding may make it uncomfortable to wear for extended periods of time. Devices for increasing and/or decreasing tension may also be used in conjunction with the load distribution device, such as a rotary tensioning dial, where the dial may be mounted on the load distribution device or on the orthosis to which it is attached. Elastic tensioning bands may also be used in-line with this system, or as part of the attachment system. The load distribution device may be attached in a hinging manner that clasps around a body part, such as mating body part. It may also lock in place with a ratchet-pawl system or a similar locking mechanism that allows securing the device to the orthosis, and/or for tightening the orthosis to the body part.
The unwanted displacement of an orthosis on a limb or body part is called migration and is a common problem. It occurs when the orthosis (or parts of the orthosis attachment system) slip either on the wearer's skin or the clothing they are wearing under the orthosis. The anti-migration solution described herein is effective for both strap-to-skin and strap-to-clothing interfaces.
The accompanying drawings illustrate certain aspects of some of the embodiments of the present invention, and should not be used to limit or define the invention. Together with the written description the drawings serve to explain certain principles of the invention.
a are depictions of an existing strap.
a are depictions of a load distribution device according to an embodiment of the current invention.
The present invention has been described with reference to particular embodiments having various features. It will be apparent to those skilled in the art that various modifications and variations can be made in the practice of the present invention without departing from the scope or spirit of the invention. One skilled in the art will recognize that these features may be used singularly or in any combination based on the requirements and specifications of a given application or design. Embodiments comprising various features may also consist of or consist essentially of those various features. Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention. The description of the invention provided is merely exemplary in nature and, thus, variations that do not depart from the essence of the invention are intended to be within the scope of the invention.
The unloading knee brace shown in
The force vectors from the energy storage element on the brace pictured in
In
The invention shown in
In aspects, the load distribution device is made of a rigid or semi-rigid material in order to transfer and redirect the unloading forces effectively. Using a rigid or semi-rigid material has the added benefit that it is possible to accommodate incomplete contact between the strap and the load distribution device. The gap (62) at the lower edge of the strap in
A shape of the load distribution device can be dependent on several factors, such as the magnitude and direction of migration forces that need to be overcome, the necessary movement of the underlying muscles and skin it is contacting (for example, the normal flex of the calf muscle when walking), the range of tightness of the adjoining strap, the material(s) used to fabricate the load distribution device, and so on. However, in general, the contact area, A, should be
A>=Ft/(P×m)
where Ft is the migration force, P is the pressure applied by the load distribution device due to the strap tension, and m is the coefficient of friction at the load distribution device/limb interface. As the migration forces increase, the contact area of the load distribution device needs to increase to compensate.
It may be advantageous, in aspects, to cover the surfaces of the load distribution device with one or more of a variety of materials. For example, a thin conformable foam pad can provide additional cushioning. A chamois covering can absorb sweat and prevent chafing. Gilly cloth can provide camouflage. Coverings and other modifications can be selected such that they do not inhibit the ability of the load distribution device to prevent migration. Silicone can be used.
In another embodiment, a load distribution device can be used to contribute to the therapeutic manipulative forces of the orthosis in addition to its anti-migration function.
The wedge can be placed in other locations on the load distribution device to impart a desired force vector (for example, along the bottom edge to generate a lifting force). A similar effect can be generated by using a mechanical element to lift the strap away from a back surface of the load distribution device, instead of employing a wedge shape.
In yet another embodiment, the attachment points of the straps can be offset. As shown in
While certain joints, limbs, and body parts have been mentioned herein, it is contemplated that the invention described herein could be applied to the neck, spine, shoulder, arm, elbow, hand, wrist, waist, leg, knee, ankle, foot, and other joints and their associated body parts. Likewise, the invention described herein could be used in conjunction with an orthosis for veterinary purposes and applied to animal joints or parts such as hocks, fetlocks, shanks, tails, etc. which don't have equivalent human parts.
The various embodiments of the load distribution device could be employed separately or in combination to simultaneously prevent the migration of a dynamic orthotic device and deliver the therapeutic manipulation force vectors. The load distribution device can be particularly suitable for the high force vectors needed for dynamic orthoses or where an orthosis strap needs to be positioned on high curvature body parts such as shoulders, calves, forearms, ankles, thighs, and the like.
In embodiments, the presence of a wound or injury on a wearer's limb/body part/joint may interfere with the preferred load distribution device geometry. A conformable sock, wrap, sleeve, elastic cloth, or the like may be employed underneath the load distribution element. The conformable wrap can have a surface area larger than the load distribution device, although that is not always necessary. The conformable wrap could be made as large as needed to provide enough skin-to-wrap (or cloth-to-wrap friction if the wrap is worn over the clothes) to overcome the forces imparted by a dynamic orthotic. The load distribution device, orthotic, and/or both could be coupled with the wrap such that they essentially lock in place. The wrap can provide, in aspects, a high friction to the limb, or friction to the limb. In turn, the orthotic/load distribution device can couple to the wrap so that forces imparted on the orthotic/load distribution device are distributed to the wrap. A rigid or semi-rigid portion of the load distribution device may also be contoured around a wound or sensitive area like an osteophyte or varicose vein, or it can be designed so that a gap or void is used to direct force to other areas of the surface instead of the wound or sensitive area.
For example, if a patient had a wound on the top of their shoulder, a load distribution device for a shoulder orthosis would lie on top of the wound and be uncomfortable to wear. A shoulder load distribution element with a cut-out to avoid direct pressure to the wound may not be able to redirect the orthosis forces adequately. In this case, a neoprene sleeve with a Velcro loop on the outer surface could be worn on the arm up to the shoulder. A shoulder load distribution device could be fashioned with the Velcro hook on the inner side and a cut-out to avoid the wound. By coupling the load distribution device to the sleeve (by the Velcro), the forces could be transmitted or redistributed from the load distribution device to the sleeve, thereby allowing the orthosis to function while still being comfortable to wear. A rotary tensioning dial and elastic tensioning system (or other type of tensioning system with or without elastic components) may direct forces around the shoulder joint using the load distribution device that is conformed to a shoulder, or also to distribute force on other body plates that conform to other body parts. For example, a back brace can utilize one or more load distributors or body plates that may be tensioned to help direct forces across the spine to an improved biomechanical state.
The load distribution device described herein can be adapted to many joints that require force manipulation across the joint, such as hip, elbow, back, ankle, or shoulder. Within the knee, one example is a device that imparts a force on the patella to direct it to a position that is more biomechanically favorable, often medially. In this case a tensioning system that is optionally adjustable may dynamically apply a pushing or pulling force across a knee brace or a sleeve. Concentrated forces directed into or near the patella would be uncomfortable and less effective than a load distribution device that can also direct force.
Another embodiment may use the load distribution device to distract a joint by, for example, pressing the calf away from the quadriceps, where the load distribution device also directs force away from the joint while simultaneously distributing force. For example, the device may tilt in a manner to where the top of the calf “belly” is held tighter to the tibial crest than the lower part of the load distributor, and so the calf then becomes an ideal surface for either preventing brace migration, or generating a counter force that could distract the knee joint.
One skilled in the art will recognize that the disclosed features may be used singularly, in any combination, or omitted based on the requirements and specifications of a given application or design. When an embodiment refers to “comprising” certain features, it is to be understood that the embodiments can alternatively “consist of” or “consist essentially of” any one or more of the features. Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention.
It is noted in particular that where a range of values is provided in this specification, each value between the upper and lower limits of that range is also specifically disclosed. The upper and lower limits of these smaller ranges may independently be included or excluded in the range as well. The singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. It is intended that the specification and examples be considered as exemplary in nature and that variations that do not depart from the essence of the invention fall within the scope of the invention. Further, all of the references cited in this disclosure are each individually incorporated by reference herein in their entirety and as such are intended to provide an efficient way of supplementing the enabling disclosure of this invention as well as provide background detailing the level of ordinary skill in the art.
As used herein, the term “about” or “around” refers to plus or minus 5 units (e.g., percentage) of the stated value.
Reference in the specification to “some embodiments”, “an embodiment”, “one embodiment” or “other embodiments” means that a particular feature, structure, or characteristic described in connection with the embodiments is included in at least some embodiments, but not necessarily all embodiments, of the inventions.
As used herein, the term “substantial” and “substantially” refers to what is easily recognizable to one of ordinary skill in the art.
It is to be understood that the phraseology and terminology employed herein is not to be construed as limiting and are for descriptive purpose only.
It is to be understood that the details set forth herein do not construe a limitation to an application of the invention.
Furthermore, it is to be understood that the invention can be carried out or practiced in various ways and that the invention can be implemented in embodiments other than the ones outlined in the description above.
The present application is a continuation-in-part of and relies on the disclosures of and claims priority to and the benefit of the filing date of U.S. patent application Ser. No. 17/700,479 filed Mar. 21, 2022, which is a continuation-in-part of and relies on the disclosures of and claims priority to and the benefit of the filing dates of U.S. patent application Ser. No. 17/537,476 filed Nov. 29, 2021, U.S. patent application Ser. Nos. 17/074,571 and 17/074,542 filed Oct. 19, 2020, U.S. patent application Ser. No. 17/211,635 filed Mar. 24, 2021, which rely on the disclosures of and claim priority to and the benefit of the filing date of U.S. patent application Ser. No. 15/585,968, filed May 3, 2017, which claims priority to and benefit from U.S. Provisional Patent Application No. 62/331,315 filed on May 3, 2016. The disclosures of those applications are hereby incorporated by reference herein in their entirety.
Number | Date | Country | |
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62331315 | May 2016 | US | |
62331315 | May 2016 | US |
Number | Date | Country | |
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Parent | 15585968 | May 2017 | US |
Child | 17074542 | US |
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Parent | 17074542 | Oct 2020 | US |
Child | 17211635 | US |
Number | Date | Country | |
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Parent | 17700479 | Mar 2022 | US |
Child | 17864675 | US | |
Parent | 17537476 | Nov 2021 | US |
Child | 17700479 | US | |
Parent | 17211635 | Mar 2021 | US |
Child | 17537476 | US | |
Parent | 17074571 | Oct 2020 | US |
Child | 17537476 | US | |
Parent | 15585968 | May 2017 | US |
Child | 17074571 | US |