Patent Grant
11253386
This disclosure relates to a rigid ankle support system and method of making the same.
It is often necessary to form products into custom shapes and fits. One area in which this is particularly relevant is in the use of protective and musculoskeletal supportive devices such as those used in the medical orthopedic field, sports medicine field, protective body gear field, or veterinary field, among other fields. These devices need to provide varied degrees of support and protection yet fit the body closely and comfortably. Items such as form fitting orthopedic casts, orthopedic braces, support devices used in sports medicine, immobilization and alignment devices used for radiation therapy, and supportive devices used in veterinary medicine, as well as protective body gear and other rigid fitted items can all benefit from improved construction techniques and materials.
Orthopedic casts and braces are typically formed on the body by wrapping a fiberglass strip impregnated with soft resin which is activated and hardened by water. They can also be formed from plaster and fabric layers which are activated by water. Polycaprolactone material, such as Orthoplast®, distributed by BSN Medical is also used for braces. This casting and splinting material is heated with hot water to the highest temperature comfortable on the skin, about 160 degrees Fahrenheit. These materials allow the cast or brace to be formed and made in situ about the patient's body part over layers of padding and stockinette. These prior materials have a limited amount of time that they are sufficiently heated to a temperature where 1) they are sufficiently malleable to be formed about the body and 2) the material does not burn the patient or practitioner.
Often casts, splints, braces and other products are required to be formed in complex shapes which are difficult to custom form and fit to a particular user. They are often formed in pieces and attached to the splint or cast body which creates a weaker support. The fit is not always particularly comfortable which leads to compliance issues. Other body injuries may require relatively complex shapes which are difficult and expensive to achieve.
Braces in particular are difficult to form into custom shapes. Braces often need to be flexible in order to allow flexing of the body parts, such as knees, ankles, wrists and other movable body parts. At the same time, the brace needs to be rigid to prevent injury to a weakened body part. Thus, most prior braces are complex mechanical devices that are difficult to create and even more difficult to custom fit to the body.
Orthopedic products such as casts, splints, braces and protective gear, as well as other products are not only difficult to form into complex shapes with conventional materials; they often do not fit the patient particularly well. Since these products are typically manufactured with mechanical mechanisms or attached together with connections such as hook and loop or adhesives, or are non-moldable, they are not able to be custom formed to the patient. This lack of custom fitting leads to discomfort which affects the compliance, use and effectiveness of the product.
Disclosed herein are moldable, rigid ankle braces and methods of making and using the same. In one aspect of the disclosure, a rigid stabilizing ankle brace is provided. The brace advantageously includes a heat-moldable multi-layer housing having an opening for receiving a user's ankle. Also provided is a footplate removably attached to the housing. The rigid ankle brace further includes a closure mechanism.
The closure mechanism may include at least one tightening strap that is anchorable to the housing and actuatable to tighten the brace about the ankle from a loose state to a tightened state. Optionally, the closure mechanism includes a cable reel elements such as the cable reel attachment systems distributed by BOA Technology Inc. Optionally, the closure mechanism is positioned medially about the housing.
In another aspect, the brace includes a multi-layer housing having an outer layer. The outer layer may be constructed of a fabric such as a knit nylon spandex blend, knit polyester spandex blend, fabrics of nylon, polyester, lycra, or rubberized materials.
Also provided in the multi-layer housing is a middle layer, wherein said middle layer is substantially stiff at a temperature below about 130° F. and moldable at temperatures between about 130° F. and 220° F. In some embodiments, the middle layer is moldable at temperatures between about 130° F. and 275° F.
In yet another aspect, the multi-layer housing includes an inner layer. The inner layer may be constructed of a closed cell foam layer, an open cell foam layer, a gel layer, a soft polymer layer, an insulating fabric, a multilayer or lofted insulating fabric, or combinations thereof Also contemplated is an inner layer having a chemical additive applied. The chemical additive may be an antimicrobial, skin lotion, or other topical therapeutic agent.
In still another aspect, a method of stabilizing an ankle is disclosed. The method includes, for example, providing an ankle brace as described above, heating the ankle brace to a temperature of between about 130° F. to about 275° F., and donning the heated ankle brace to the ankle of a patient in need thereof. The orientation of the brace is optionally manipulated by a health care provider to align the brace relative to said ankle.
The accompanying drawings, which are incorporated herein and constitute a part of the specification, illustrate embodiments of the disclosure and, together with the description, serve to explain the objects, advantages, and principles disclosed. In the drawings:
After reading this description it will become apparent to one skilled in the art how to implement the principles of this disclosure in various alternative embodiments and alternative applications. All possible embodiments of the present disclosure, however, will not be described in detail herein. It is understood that the embodiments presented herein are presented by way of example only. As such, this detailed description of various alternative embodiments should not be construed to limit the scope or breadth of the present disclosure as set forth below.
Disclosed in the present application are a system for orthopedic bracing and a method of the manufacture thereof. A brace is a device used to assist or restrict body movement. As used herein, the terms brace and support may be used interchangeably. An orthosis is an external orthopedic appliance used to support, assist, align, prevent, or correct a deformity or improve function of a movable part of the body. The disclosed bracing system is based, in part, on the surprising and unexpected finding that a brace formed in part of a low temperature, high modulus construction material may provide a quick and custom ankle brace. It is a boon to orthopedic brace construction at least because this innovative brace reduces the number of visits needed for an individual in need thereof to obtain a custom ankle orthosis. The ankle brace as described herein can be fitted in as little as one office visit, thereby reducing the costs to patients, physicians, and healthcare systems. Additionally, the ankle brace provides quick relief and comfort to the patient.
As shown in the embodiment of
Ankle brace 10 further may include a footplate 14 configured to support at least a portion of a user's foot. Footplate 14 may include a heel portion 141 configured to receive the heel of a user of the ankle brace 10. In some embodiments, the footplate 14 may be configured to support only a portion of a user's foot. For example, in some embodiments, footplate 14 may be configured to support only a user's heel and may not extend under a front portion (toe end) of a user's foot. In another embodiment, the footplate 14 may support an entire foot of the patient, extending from heel to toe. The specific construction and shape of the footplate 14 will be discussed in greater detail below.
As shown in the embodiment of
In some embodiments, ankle brace 10 may be configured for use without footplate 14, for example, by using housing 12 alone to support and brace a user's ankle. This may be possible because of the heat moldable multi-layer construction of housing 12, which is configured to allow molding to a custom shape. In embodiments of ankle brace 10 that do not include footplate 14, the housing 12 may be molded to provide support to a user's foot, as well as to provide support to a user's ankle and leg.
As will be discussed in greater detail below, the housing 12 may be configured with one or more selectively openable openings (not shown in
Moreover, ankle brace 10 may include one or more closure mechanisms, each of which may comprise a plurality of closure elements, which allow the housing 12 of ankle brace 10 to be tightened around a user's ankle. In some embodiments, the closure mechanisms may further be used to selectively close the one or more selectively openable openings used to facilitate the donning and doffing of ankle brace 10.
In the embodiment of
In some embodiments, the housing 12 and/or footplate 14 may be configured with low profile trims so that ankle brace 10 may be worn under most shoes.
Advantageously, the outer layer 22 provides insulation from heat so that the ankle brace 10 can be handled upon removal from a heating treatment and has enough stretch to form to various shapes encountered in the human ankle (as will be more fully described below). The outer layer 22 may also be made of a stiff foam to provide additional support, as well as environmental protection and/or aesthetics.
When comparing outer layer 22 with the outer surface of a typical plaster or fiberglass brace, it should be noted that outer layer 22, as described above, provides significant improvements in comfort, aesthetics, durability and ease of use.
Additionally, in some embodiments, a fabric, synthetic leather, or other cosmetic covering may be laminated to the outside of the outer layer 22 for purposes of aesthetics or durability. In some embodiments, the fabric known as unbroken loop can be applied at some locations of the ankle brace 10 which has a surface compatible with common hook and loop fasteners such as Velcro™. This may allow closures, extra supports, multipart braces and other devices to be instantly connected using common hook strip fasteners.
The middle layer 24 is the main construct of the housing 12 and is made from a low temperature, high modulus composite material which comprises a percentage of carbon fiber reinforcements added to a polyester PET base plastic. In some embodiments, the middle layer 24 is made from a composite material comprising an 80% polyester PET base reinforced with 20% carbon fiber. In other embodiments, the ratio and/or type of reinforcing material added to the base may be varied. For example, in some embodiments the composite material may comprise 10% carbon fiber and 3% glass as the reinforcing material. In some embodiments, the composite may comprise between 1% and 40% carbon fiber. In some embodiments the composite material may include 10% carbon fiber alone. In some embodiments, the composite material may comprise 5% carbon fiber.
The low temperature, high modulus material of middle layer 24 may be a reinforced thermoplastic polymer material that is easily formable/moldable at relatively low temperatures. For example, in certain embodiments, the material is moldable in a low temperature range that is preferably between about 130° F. to about 220° F. In some embodiments, the material is moldable in a low temperature range that is preferably between about 130° F. and 275° F. Further, the material of the middle layer 24 is stiff at temperatures below approximately 130° F. Accordingly, in some embodiments, the middle layer 24 is heat formable after heating to between about 130° F. and about 275° F. so that it can be fit in real time to the patient and then stiffen as it cools for a patient-specific fit. Again, this process will be described in greater detail below.
Examples of suitable materials for the thermo-formable base polymer of the middle layer 24 include, without limitation, thermoplastic alloys formed from one or more polymers. Suitable polymers include polyester, polyethylene, polyvinyl chloride, polyethylene tetraphthalate, polyamide, or PVC foam such as Sintra™ or Komatex™ or combinations thereof. An example of a suitable heat-formable material includes the thermo-formable material provided by DJO Global under the trademark “Exos 40BX.”
In certain embodiments, the modulus of the composite material of the middle layer 24 will exceed the modulus of the base material by at least twice. In other words, the middle layer 24 may be made from a composite material, comprising a base material and a reinforcing material, and the composite material may be configured so that its modulus is at least twice that of the base material alone.
The inner layer 26 of the housing 12 is constructed from a material that provides both comfort and hygiene to the wearer of the ankle brace 10. The inner layer 26 faces the inner side 21 of the ankle brace and interfaces directly with the body of a user. In one embodiment, the inner layer 26 is constructed of foam. In another embodiment, the inner layer 26 is constructed from fabric. In yet another embodiment, the inner layer 26 is constructed from a combination of foam and fabric. The inner layer 26 can also, in some embodiments, be manufactured from materials such as closed cell foam, open cell foam, gel or soft polymer, insulating fabric, multilayer or lofted insulating fabric, or any other cushioned insulative material.
In some embodiments, the inner layer 26 is compressible to comfortably fit closely around a body part of a user. The inner layer 26 also provides cushioning to increase the comfort and compliance of use. The inner layer 26 can comprise a closed cell construction to allow the ankle brace to be waterproof, or it can comprise an open cell construction to provide increased breathability if waterproof features are not desired. This layer can also be a foam formulation configured to accept and dispense therapeutic chemical additives such as antimicrobials, skin lotions, or other medicines and chemicals. In some embodiments, visco-elastic memory foam can be used for this layer to conform precisely to the patient's body.
The multi-layer construction may include holes perforated through the three layers to form holes in various amounts and shapes to provide ventilation, forming features, access to wounds or access to catheters etc. These apertures also allow the middle layer 24 to expand and shrink as necessary as the brace is being molded to the body part. The brace may also be perforated to accept various closure system attachments. In some embodiments, the housing 12 is wrapped once around the extremity and overlapped to some degree. This is to accommodate the varied body diameters and shapes encountered within each sized product and is a feature not found with typical plaster and fiberglass braces. The overlap is also the spot where the closure devices will be placed that allow the brace to be opened or closed in circumference during use. The overlapping ends may thus form an openable opening that allows a user to don and doff the ankle brace 10.
In some embodiments, footplate 14 may also comprise the multi-layered construction described above.
This multi-layered construction for the ankle brace 10 enables the brace to be formed and custom shaped about a body part by heating the product at a relatively low temperature, placing the heated product about the body part, and applying pressure to custom form the product. The process for conforming or molding an ankle brace 10 to the specific and unique musculoskeletal shape of a patient will now be described in detail.
As an initial step, an ankle brace 10 having a general shape is provided. The general shape may be preconfigured to fit generally around the lower leg and ankle of a patient. In some embodiments, the general shape is configured as a one-size-fits-all shape that can be molded, according the method described herein to fit a particular patient. In some embodiments, a patient or a healthcare provider may select an ankle brace 10 having a general shape from among a limited number of size options. For example, in some embodiments, ankle braces 10 may be provided in a first size with a general shape configured to fit adults and a second size with a general shape configured to fit children. In some embodiments, a user or healthcare provider may select a housing 12 with one size and a footplate 14 with a different size, so as to provide increased customization. It should be noted, however, that in some embodiments, only a single size is provided which can be conformed to fit most any patient. The ankle brace 10 provided in the first step is made according to the multi-layer construction described above with reference to
Next, the ankle brace 10 is heated in a heating/warming source to the prescribed temperature, which in some embodiments is between about 130° F. to about 275° F. As the ankle brace 10 is heated, the middle layer 24 becomes pliable and moldable. Once the desired temperature is achieved, the ankle brace 10 can be removed from the heating/warming source.
In some embodiments, the heating/warming device may be configured to be portable. This may allow a healthcare provider to bring the heating/warming device to the patient. This may be advantageous because it may allow for a complete custom fitting in a single home visit. In some embodiments, however, the ankle brace can be heated in any conventional heating source capable of heating to the prescribed temperature, including a conventional home oven. This may allow a user to purchase an ankle brace and then custom fit it at home. In some embodiments, however, it is advantageous to have a healthcare provider custom fit the ankle brace to ensure a proper fitting.
Next, the heated ankle brace 10 is placed on the patient's ankle while a medical professional holds the foot and ankle in the desired alignment. The medical professional can then gently mold the ankle brace to the specific shape of the patient's ankle by applying gentle pressure on the ankle brace.
In some embodiments, the medical professional may apply pressure to the housing 12 with his/her hands in order to mold the housing 12 to the specific shape of the lower leg of the patient. In some embodiments, the various closures (which will be described in greater detail below) may be tightened while the ankle brace 10 remains heated and the pressure of the closures may mold the ankle brace 10 to the contours of a patient's ankle.
As the ankle brace 10 cools, the middle layer 24 hardens in the molded configuration about the ankle, providing a stabilizing ankle support structure that is specific to that ankle.
Advantageously, the ankle brace 10 can be re-heated and re-shaped to adjust the configuration of the orthosis in response to changes in the patient's anatomy such as swelling in the ankle.
Specific additional features present in some embodiments of the ankle brace 10 will now be discussed in greater detail with reference to
In some embodiments, the closure system may comprise a cable reel 32 and a lace 34, where the lace 34 is interwoven through lace supports 36 on each side of the dorsal opening of the brace. The cable reel 32 may then be used to tighten the brace. In other embodiments, the ankle brace 10 may include a traditional tied lace, Velcro, ratchet and latch or other type of closure to tighten the dorsal foot section of the brace. In some embodiments, the dorsal foot section may not include a closure mechanism, for example, in embodiments where the housing uniformly covers the dorsal portion of a foot.
The ankle brace 10 further includes a seam and hot stitch line 42 on the anterior section of the support 10. In preferred embodiments, hot stitching is used to mount the components of the rigid support brace. In other embodiments, the seam 42 might comprise an anterior opening, to accommodate donning the ankle brace 10. In such embodiments, a lace 42 may secure the opening.
In some embodiments, the housing 12 may comprise a posterior entry (as discussed below) and one or more closure systems. The posterior entry is adapted to accommodate different widths of the foot while the closure systems are configured to secure the product to the leg, and to allow for various circumferences of the calf. The ankle brace 10 includes at least one fastener, for example an exterior strap or a lace 34. The fastener is anchorable to the housing, for example, by Velcro or by tightening the lace, and is actuatable to tighten the brace about the ankle at the mid-foot region and calf along the over wrap. However, it will be appreciated that any number of closure systems can be utilized to secure and modify the closure of the support brace relative to the patient's body. Securement can be accomplished, for example, using Velcro, buckles, cables, etc. As will be described with reference to
In some embodiments, other fastening mechanisms can be used in place of or in addition to the mechanisms described above, including cord locks, cam cord locks, traditional lacing bows, ratchet lace systems, and other lacing methods. An alternative system using ski boot buckles such as ratchet strip buckles can also be used in a similar fashion with pieces of hook fabric at either end as described in PCT/US2010/025119, the entire contents of which are incorporated herein by reference.
The various adjustable closure mechanisms described herein allow for readjustment of the ankle brace 10 relative to the patient's leg to respond to change of volume swelling. As will be appreciated by a person having skill in the art, the ability to tighten and/or loosen the ankle brace 10 allows for the use of the brace on patient populations who may not otherwise be candidates for wearing a brace. For example, in the case of edema, bracing is contra indicated for a patient. However, with the adjustable closure mechanism, the ankle brace 10 can accommodate a patient dealing with edema. Furthermore, the customized fitting of the ankle brace 10 coupled with the ability to modify the fit of the brace relative to a patient's ankle (to account for swelling, calf width, etc.) facilitates the ease by which a patient may apply and remove the brace.
Also shown in the embodiment of
In some embodiments, ankle brace 10 may include a rocker sole 56 attached to the bottom of the ankle brace 10. The rocker sole 56 may be permanently or selectively attached. In some embodiments, the rocker sole 56 may include tread, so that the ankle brace 10 can be worn without a shoe. In further embodiments, the rocker sole 56 may comprise a curved shape to aid the user in walking without the movement of the ankle.
Certain aspects of the closure system of
The ankle brace can be formed by injection molding using a 3-dimensional mold that accommodates medial-lateral thickness, anterior-posterior width, and preshaped contouring along the medial face, particularly in the ankle region. In alternative embodiments, the brace can be machined,die-cut, or 3D printed.
The ankle brace can be used to treat a plurality of ankle instabilities and indications. Indications may include, without limitation, use for the treatment of Posterior Tibial Tendon Dysfunction (PTTD), ankle arthritis, lateral ankle instability, and treatment of Achilles tendons.
In some embodiments, a rigid stabilizing ankle brace may include a heat-moldable single-layer housing having a selectively openable opening for receiving a user's ankle, and a closure mechanism disposed on the housing. In some embodiments, the single-layer housing may be made from a material that substantially stiff at a temperature below about 130° F. and moldable at temperatures between about 130° F. and 220° F. In some embodiments, the single-layer housing may be made from a material that substantially stiff at a temperature below about 130° F. and moldable at temperatures between about 130° F. and 275° F. The heat-moldable housing may also include a footplate. In some embodiments, the closure mechanism includes at least one tightening strap or lace that is anchorable to the housing and actuatable to tighten the brace about the ankle from a loose state to a tightened state.
In some embodiments these principles may be applied to form braces for other body parts, including, but not limited to, hands, wrists, elbows, shoulders, knees, hips, spine, or neck. While the various figures depicting side views of embodiments of ankle brace 10 have been described as showing either a medial or lateral side of the brace, other embodiments exist which may be represented by the same figures, yet describe the opposite side of the brace. For example, while
Each reference in the present application is hereby incorporated by reference in its entirety. Further, the above description of disclosed embodiments is provided to enable any person skilled in the art to make or use the invention. Various modifications to the embodiments will be readily apparent to those skilled in the art; the generic principles defined herein can be applied to other embodiments without departing from spirit or scope of the invention. All references cited are hereby incorporated by reference herein in their entireties and made part of this application. The invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.
This application claims the benefit under 35 U.S.C. § 120 as a continuation of U.S. application Ser. No. 14/612,136, filed on Feb. 2, 2015, now U.S. Pat. No. 10,092,439, which claims the benefit of U.S. Provisional Application No. 61/935,755, filed on Feb. 4, 2014 and U.S. Provisional Application No. 61/935,756, filed Feb. 4, 2014, each of which is hereby incorporated by reference in its entirety.
| Number | Name | Date | Kind |
|---|---|---|---|
| 4771768 | Crispin | Sep 1988 | A |
| 4888225 | Sandvig et al. | Dec 1989 | A |
| 4934355 | Porcelli | Jun 1990 | A |
| 5069202 | Prock | Dec 1991 | A |
| 5176623 | Stetman et al. | Jan 1993 | A |
| 5429588 | Young et al. | Jul 1995 | A |
| 5720715 | Eriksson | Feb 1998 | A |
| 5934599 | Hammerslag | Aug 1999 | A |
| 5971946 | Quinn et al. | Oct 1999 | A |
| 6053884 | Peters | Apr 2000 | A |
| 6202953 | Hammerslag | Mar 2001 | B1 |
| 6289558 | Hammerslag | Sep 2001 | B1 |
| 6767332 | Pardue et al. | Jul 2004 | B1 |
| 7785283 | Bledsoe | Aug 2010 | B1 |
| 8048012 | Castro | Nov 2011 | B1 |
| 10004627 | Madden et al. | Jun 2018 | B2 |
| 10092439 | Madden | Oct 2018 | B2 |
| 20020095750 | Hammerslag | Jul 2002 | A1 |
| 20030204938 | Hammerslag | Nov 2003 | A1 |
| 20050085755 | Rabe | Apr 2005 | A1 |
| 20060156517 | Hammerslag | Jul 2006 | A1 |
| 20080060167 | Hammerslag | Mar 2008 | A1 |
| 20080060168 | Hammerslag | Mar 2008 | A1 |
| 20080066272 | Hammerslag | Mar 2008 | A1 |
| 20080066345 | Hammerslag | Mar 2008 | A1 |
| 20080066346 | Hammerslag | Mar 2008 | A1 |
| 20080083135 | Hammerslag | Apr 2008 | A1 |
| 20110196276 | Kuhn | Aug 2011 | A1 |
| 20130204172 | Viehweg | Aug 2013 | A1 |
| 20130289463 | Watts | Oct 2013 | A1 |
| 20130310724 | Kazlow et al. | Nov 2013 | A1 |
| 20140066829 | Drillio | Mar 2014 | A1 |
| 20140213953 | Heyd | Jul 2014 | A1 |
| 20140276316 | Bradshaw | Sep 2014 | A1 |
| 20190029863 | Madden et al. | Jan 2019 | A1 |
| Number | Date | Country |
|---|---|---|
| WO 10099130 | Sep 2010 | WO |
| Entry |
|---|
| International Search Report and Written Opinion dated Apr. 29, 2015 in PCT/US15/014142. |
| International Search Report and Written Opinion dated Apr. 29, 2015 in PCT/US15/014134. |
| Number | Date | Country | |
|---|---|---|---|
| 20190070032 A1 | Mar 2019 | US |
| Number | Date | Country | |
|---|---|---|---|
| 61935756 | Feb 2014 | US | |
| 61935755 | Feb 2014 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 14612136 | Feb 2015 | US |
| Child | 16153553 | US |
