Patent Application
20230201018
The teachings of this disclosure generally relate to an orthopedic bracing system and method for bracing a patient's leg throughout the period of recovery from an injury or surgery.
Certain types of injuries and surgeries require the patient's ankle, foot and lower leg to be immobilized at different stages and supported to facilitate recovery. It is also frequently necessary to reduce or eliminate the amount of weight being borne by the ankle or foot during the recovery period following an injury or surgery. Further, providing increased protection from the environment for the foot or ankle may also be required during the recovery period.
Currently available orthopedic devices generally only accomplish one of the three objectives. For example, an ankle-foot orthosis (“AFO”) will stabilize and support the foot and ankle in an optimal position, but will only offer limited protection of the foot and ankle from the environment and will not offload the weight of the user from the foot and ankle. For limb protection and off-loading, a combination of casts or walking boots with crutches, walkers, scooters and other devices must be used. Consequently, a patient may be required to purchase and use multiple devices over the course of his or her recovery.
Further, many orthopedic braces have to be custom fit to the user. This often requires a lengthy process that includes sending a patient to an outside lab for fabrication of the brace. The process is expensive, time consuming and frequently delays treatment for several weeks or more.
Another problem with existing bracing systems is compliance. Because the individual elements of a complete bracing system are not designed to work together in a way that is cost-effective and convenient for the patient and do not take into account the patient's needs at different stages of recovery, or even at different times of the day, many patients do not comply with the treatment instructions. Noncompliance or removal of the bracing system prematurely may result in harm to the foot, ankle and leg with, for instance, displacement of a fracture, delayed healing of a wound or a prolonged period of recovery and rehabilitation. For example, a walking boot is often used to protect an injured or post-operative foot and ankle without the expense of a custom-fit AFO. However, these boots often become dirty over the course of the day. They are large, cumbersome and frequently cause the lower limb to become hot and sweaty. For these reasons and others, patients often remove the boots during the day for relief and at night rather than bringing the unsanitary boot into bed. As a result, the foot and ankle are left unprotected and are not maintained at the proper angle intermittently during the day and during most of the night. This can lead to contractures or other injuries that may require more healing time, additional surgery and more extensive rehabilitation than if the ankle were braced in the correct position at all times. Patients sometimes also forget to put the walking boot back on before getting off the couch or out of bed, causing further harm. Noncompliance with the walking boot, removing it during the day and at night, is a prevalent problem.
Moreover, a patient's needs change over the course of recovery, but currently available devices are not designed to easily adapt. For example, in the beginning, a patient may not be able to bear any weight on an injured foot and crutches may be prescribed to offload the foot. As recovery progresses, the patient may only need to offload 50% of his or her weight, but it is difficult to know how to bear 50% of one's weight on crutches and so patients often just carry the crutches around with them, placing 100% of their weight plus the weight of the crutches on the injured foot.
What is needed is an orthopedic bracing system that can be adapted to fit a wide range of patients without the delay and expense of custom fitting and that can meet most or all of the patient's needs throughout the stages of recovery and throughout the patient's normal daily routine. Also needed is a device that can offload and protect a limb during the day and night even if the outer bulky shell, or walking boot, is removed.
The present disclosure provides a modular orthopedic bracing system, which includes an ankle-foot orthosis (“AFO”), a walking boot and a patellar tendon bearing brace (“PTB”). In certain embodiments, the PTB is replaced with a support that attaches to the patient's thigh and upper calf area.
The AFO can be configured to maintain a patient's foot, ankle and lower leg at the prescribed angle to allow healing and avoid, for example, contracture. The exterior shell of the AFO is formed from a rigid or semi-rigid material, e.g., plastic. The AFO has a base that attaches to and supports the patient's foot and an upright portion, which forms an angle with the base. The angle between the base and the upright portion may be generally perpendicular. The upright portion attaches to the patient's leg with, e.g., straps. The AFO can be detachably connected to a walking boot to provide additional support and to maintain the foot, ankle and lower leg at the prescribed angle. Since the AFO can be detached from the walking boot, it may also be worn by itself during times when only support is required, such as when the patient is sleeping, resting during the day or, during later stages of recovery, it can be worn within an ordinary shoe.
A PTB can also be detachably connected or permanently attached to the walking boot. The PTB can offload some or all of a patient's weight and is advantageous over crutches, walkers or other assistive devices because it does not require weight to be borne by the upper body, which makes a PTB generally easier to use. The PTB may partially or fully suspend the patient's foot, ankle and lower leg within the walking boot.
The inventive modular design of the system disclosed herein allows the patient to remove the walking boot during periods in which it may be cumbersome or unnecessary for the patient. For example, the walking boot may be removed for sleeping or resting because it is detachable from the AFO such that the AFO can remain on the foot without the walking boot. The AFO can provide sufficient bracing and protection for activities like sleeping or resting, but without the inconvenience and discomfort caused by the added bulk and weight of a walking boot.
Advantageously, the modular design and adjustable nature of the system disclosed herein allow patients to use a single system for their complete recovery. For example, as the patient becomes able to bear more weight on the foot, the relative proportion of the patient's weight borne by the PTB and the foot bed of the boot can be appropriately adjusted to accomplish this in a controlled and systematic fashion as opposed to other methods, like crutches, which do not allow for systematic control of the weight being borne by the foot.
Further, it is advantageous that the modules of the orthopedic bracing system can be connected. For example, connecting the AFO to the walking boot prevents the AFO from sliding inside the boot, increases stability and reduces friction on the wound.
Also disclosed herein is a new design for a walking boot that is configured to work with the overall orthopedic bracing system and address long-standing problems in the art. The most widely used medical or orthopedic walking boot contains a rubber sole, metal base with foam padding and two vertically oriented metal posts with VELCRO® strips attached to the inner and outer surfaces of the posts. A soft fabric liner rests on the padded metal base. The liner attaches to the inner surface of the two metal posts with VELCRO®. The fabric liner is open in the front to accept a patient's leg. After the leg is resting in the boot, the liner is closed and 3 to 4 circumferential VELCRO® straps are attached to the outer surface of the two metal posts with VELCRO® and then tightened to hold the leg securely. There are several practical problems with this design. The circumferential VELCRO® straps adhere to themselves, adhere to one another, are detachable and frequently lost, frequently tangled, turned over, knotted and, out of anger, simply cut and discarded.
The liner suffers from similar problems. It sticks to anything with VELCRO®. It is difficult to remove from the metal posts of the boot and usually requires that all of the VELCRO® straps be taken off as well. Thus, removing the liner to wash it and place it back into the boot is frustrating in most cases. However, if the liner is not routinely washed, it becomes malodorous. Replacing the liner properly requires knowledge of the product and patience. Few patients are able replace the liner and maintain a good fit. Many patients return to the health care provider's office upset that they are unable to manage the boot with its straps and liner.
The new fabric liner disclosed herein addresses these issues. VELCRO® can be removed entirely from the side posts. In one non-limiting embodiment, the liner may be provided with two wide side pockets that slide over and capture the side posts. The opening of the pockets are along the inferior or bottom side. The side pockets are reinforced to prevent tearing. The side pockets may also be trapezoidal in configuration, e.g., wider on top and narrower on the bottom. This will allow more adjustment for different size calves. Narrower at the bottom will help to maintain proper liner and foot position with respect to the base of the boot. In general, wide side pockets allow the liner to be moved back for larger legs and forward for smaller legs.
Without VELCRO on the two side posts, the liner can be easily placed into position and removed. Removing the liner for washing, caring and reassembly is simple and easy. The liner only fits on the boot one way to prevent confusion.
Two wide straps with limited VELCRO® at the ends may be permanently attached to the liner to prevent loss of straps, poor positioning of straps, and minimize tangling of the straps. The straps may be oriented in opposite directions to facilitate tightening of the straps and secure fit of the boot. VELCRO® or other means may also be used at the bottom of the liner to fix it to the padded metal base.
Alternatively, the liner may be closed using two wide straps with loops at the ends that secure to knobs or hooks on the side posts. In this example, the side pockets may have a cutout to allow access to the knobs or hooks on the side posts. In another embodiment, the liner may be closed using a series of bands that are attached to one end of a connector with the other end of the connector being attached to the side posts. The side pockets may have a cutout to allow access to the connector on the side posts. Alternatively, the liner may be closed using a drawstring closure, side release buckles or a bail and catch system.
The liner may optionally include mesh sections to allow for increased airflow. The mesh sections may be on the back of the liner, the sides of the liner or the foot section of the liner.
The liner may also optionally include a pneumatic device for compression. The pneumatic device may be inflated using for example, an inflation bulb, a manual pump, or an open-cell foam in conjunction with an air valve.
Similar to other walking boots that may be used with the disclosed orthopedic bracing system, the AFO can be attached to the fabric liner walking boot. For example, the AFO may be attached to walking boot via a knob and rail connection, via straps that pass though the liner and the base of the walking boot and wrap around the users ankle or, in another example, a strap may connect the AFO to the liner and any of the methods described herein may be used to attach the liner to the walking boot base and posts. The AFO may also be attached to the walking boot using a continuous strap.
A PTB or a support that attaches to the patient's thigh may also be used in conjunction with the fabric liner walking boot.
A trapezoidal shaped extender pad can optionally be added to the liner for extremely large and wide legs. Currently, walking boots are fit to the size of a patient's foot but in an ever-increasing set of patients, their lower legs and calves are too large to close the liner. Frequently the boot liners are left open anteriorly or boots are oversized for the feet in order to close around the calves but this creates a tripping hazard. The extender pad can be made from the same material as the liner and easily added to the liner with VELCRO® to adequately cover larger legs.
In a first embodiment, this disclosure provides a walking boot configured to cover a portion of a user's foot, ankle and lower leg. A PTB is detachably connectable or may be permanently connected to the walking boot and configured to partially or fully suspend a portion of the user's weight. An AFO is also detachably connectable to the walking boot.
In an aspect of the first embodiment, the AFO can be configured for insertion into a shoe. For example, at a later stage of recovery the walking boot may not be required, but some bracing may still be needed for stability and to maintain the proper angle of the foot. At such a stage of recovery, the AFO may be removed from the boot and used with an ordinary shoe.
In a second aspect of the first embodiment, the AFO has a base that is configured to cover the sole and arch of the user's foot and an upright portion that is configured to cover the user's heel and the posterior portion of the user's ankle. However, one of skill in the art can appreciate that the AFO may be configured to extend up the calf or even cover the entire calf of the user.
In another aspect, the AFO can be a universal or generic fit that fits most foot types. Alternatively, the AFO may be easily molded to create a more secure fit and improved support. For example, the AFO may be molded in a healthcare professional's office.
In another aspect of this embodiment, the PTB is constructed of a posterior shell and an anterior shell and a strap connects the posterior and anterior shells. The strap may pass through a ring connected to an arcuate track in the posterior shell or the anterior shell. This provides the ability to adjust the PTB to fit users of different sizes and heights.
In another aspect, the location of the connection between the PTB and the walking boot is adjustable. Adjusting the height of the PTB further enhances the ability of the orthopedic bracing system to accommodate patients of various heights and may also improve control over the amount of weight being borne by the user's foot and ankle.
In another aspect, the PTB is configured to provide a first upward force on a user and the foot bed of the walking boot is configured to provide a second upward force on the user and the relative amounts of the first and second upward forces are adjustable.
In another aspect, a wedge is positioned under the sole of the walking boot placing the sole of the walking boot at an angle to the ground. The angle created by the wedge may be variable between 1° and 60°.
In another embodiment this disclosure provides a walking boot configured to cover a portion of the user's foot, ankle and lower leg. An AFO can be detachably connectable to the walking boot.
In one aspect, the walking boot has a foot bed and the distance between the AFO and the foot bed can be adjusted.
In another aspect, the AFO is attached to the walking boot by a track, rail, spine, extension, prominence, flush mount bracket, a snap fit connection, a hook and loop connection (e.g.,)VELCRO®), a magnet or a strap. For example, the walking boot may have a track, rail, spine, extension, prominence or flush mount bracket on an interior surface and the AFO may have a channel, slot, groove, recess, depression, receptacle, or flush mount bracket on its exterior surface configured to cooperate with the attachment mechanism on the interior surface of the walking boot. The channel, slot, groove, recess, depression, or receptacle on the exterior of the AFO would capture the track, rail, spine, extension, or prominence of the walking boot to releasably attach the AFO to the walking boot. A flush mount bracket, button, knob or lever on the exterior of the AFO may be configured to cooperate with a flush mount bracket or track in the walking boot to detachably connect the AFO to the boot. Alternatively, the AFO may have a flush mount bracket or track on an exterior surface and the walking boot may have a flush mount bracket, button, knob or lever on its interior surface. The flush mount bracket, button knob or lever on the interior of the walking boot may be configured to cooperate with the flush mount bracket or track on the AFO to detachably connect the AFO to the walking boot. Other suitable structures for attaching the AFO to the boot are also contemplated by this disclosure.
In another embodiment, a method for supporting an injured lower extremity is provided. For example, a first support member may be attached to a region surrounding the patellar tendon of the injured patient. A second support member for the area at or beneath the foot may be provided. A first upward force may be provided at the patellar region of the user by the first support member and a second upward force may be provided at the user's foot with the second support member. The amounts of the first upward force and the second upward force may be adjusted to a desired balance.
In one aspect, the magnitude of the first and second forces may be adjusted by changing the positions of the first and second support members.
In another aspect, the first support member is a PTB.
In another aspect, a prescribed angle can be maintained between the foot and the leg after the amounts of the first upward force and the second upward force are adjusted.
In another aspect, an AFO may be used to maintain the prescribed angle between the foot and the leg.
In another embodiment, a brace assembly is provided. The brace assembly includes a walking boot configured to cover at least a portion of the plantar aspect of a user's foot, and an alternative support that may be connected to the walking boot, the support having a first support portion configured to attached to the user's thigh. The alternative support may replace the PTB in certain embodiments described herein. The support includes a lockable joint. When the joint is unlocked, an angular position of the first support portion relative to the walking boot is adjustable, and when the joint is locked, the angular position of the first support portion relative to the walking boot is fixed.
In another embodiment, a brace assembly is provided. The brace assembly includes a walking boot configured to cover at least a portion of the plantar aspect of a user's foot, and an alternative support that may be connected to the walking boot, the support having a first support portion configured to attach to the user's thigh. The alternative support may replace the PTB in certain embodiments described herein. Further, the walking boot has a base axis and a calf axis and an adjustable angle β therebetween. The position of the user's calf relative to the base of the walking boot is adjustable.
In another embodiment, a brace assembly is provided. The brace assembly includes a walking boot configured to cover at least a portion of the plantar aspect of a user's foot, and an alternative support that may be connected to the walking boot, the support having a first support portion configured to attach to the user's thigh. The alternative support may replace the PTB in certain embodiments described herein. Further, the walking boot has a base whose height is adjustable.
In another embodiment, a brace assembly is provided. The brace assembly includes a walking boot configured to cover at least a portion of the plantar aspect of a user's foot, and an alternative support that may be connected to the walking boot, the support having a first support portion configured to attach to the user's thigh. The alternative support may replace the PTB in certain embodiments described herein. Further, the brace assembly includes an ankle-foot orthosis (“AFO”) detachably connectable to the walking boot.
In an aspect of the above embodiments, the alternative support further includes a second support portion configured to attach to the user's leg below the patella.
In an aspect of the above embodiments, when the joint of the alternative support is unlocked, the position of the second support portion is fixed relative to the walking boot and is adjustable relative to the first support portion.
In an aspect of the above embodiments, the first support portion may have a shape configured to surround the user's thigh.
In an aspect of the above embodiments, the walking boot may have a base axis and a calf axis and an adjustable angle β therebetween. The position of the user's calf relative to the base of the walking boot is, thus, adjustable.
In an aspect of the above embodiments, the walking boot has a base whose height may be adjustable. The height may be adjusted by a wedge or a block. The wedge or block may be attached to the foot bed of base of the walking boot. Alternatively, the wedge or block may be attached to the sole of the base of the walking boot.
In an aspect of the above embodiments, the brace assembly includes an AFO detachably connectable to the walking boot. The AFO may be attached to the walking boot by one of a rail, a track, a rail and a protrusion, a flush mount bracket, a snap fit connection, a hook and loop connection, a magnet, a strap and a continuous strap.
In an aspect of the above embodiments, the brace assembly may optionally include a pneumatic feature configured to provide compression to the user's foot, ankle and/or lower leg. The pneumatic feature may include an inflation bulb, a pump and/or a self-inflating bladder.
As noted above, one advantage of certain embodiments in accordance with this disclosure is that the patient may use a single system as disclosed herein for their entire recovery. In particular, the detachability and adjustability feature of the AFO and PTB modules in the disclosed embodiments allows the user's weight to be adjusted as the patient recovers such that additional weight may be taken from the PTB and borne by the foot/ankle.
Another advantage of certain embodiments disclosed herein is the modularity, which also makes it possible for a single system to be used for the patient's entire recovery and reduces certain perceived barriers to compliance. For example, as discussed above, when the patient is sleeping the boot may be removed and placed aside while the AFO is left on the limb such that the patient's comfort is increased due to not having to wear the bulky, heavy and ungainly boot. Similarly, the AFO can be adapted in the later stages of recovery such that the patient can slip a foot with the AFO already attached into a shoe.
Another advantage of certain embodiments disclosed herein is the adjustability of the modules in the system, which allows patients of different sizes to use the same braces. For example, the same PTB or alternative support may be adjusted to fit patients of various sizes rather than needing a PTB or support custom made for each patient. The boot, and the AFO can be designed to accommodate different size feet, ankles and lower legs.
The above-mentioned aspects of exemplary embodiments will become more apparent and will be better understood by reference to the following description of the embodiments taken in conjunction with the accompanying drawings, wherein:
The embodiments described below are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art may appreciate and understand the principles and practices of this disclosure.
In this disclosure, terms such as “horizontal” and “vertical” are generally used to establish positions of individual components relative to one another rather than an absolute angular position in space. Further, regardless of the reference frame, in this disclosure terms such as “vertical,” “parallel,” “horizontal,” “right angle,” “rectangular” and the like are not used to connote exact mathematical orientations or geometries, unless explicitly stated, but are instead used as terms of approximation. With this understanding, the term “vertical,” for example, certainly includes a structure that is positioned exactly 90 degrees from horizontal, but should generally be understood as meaning generally positioned up and down rather than side to side. Other terms used herein to connote orientation, position or shape should be similarly interpreted. Further, it should be understood that various structural terms used throughout this disclosure and claims should not receive a singular interpretation unless it is made explicit herein.
Further, it should be understood that all terms used throughout this disclosure and claims, regardless of whether said terms are preceded by the phrases “one or more, “at least one, or the like, should not receive a singular interpretation unless it is made explicit herein. That is, all terms used in this disclosure and claims should generally be interpreted to mean “one or more” or “at least one.”
The terms “support” and “alternative support” are used interchangeably throughout this disclosure. Minimally, these terms refer to a brace or support including first and second support portions. The first support portion may be configured to surround the user's thigh and the second support portion may be configured to surround the patient's leg at or below the patella.
The first module of the orthopedic bracing system 2 is the PTB 4.
The PTB 4 may be formed in two parts, the posterior shell 6 and the anterior shell 8. The posterior shell 6 and the anterior shell 8 may be connected by straps 10. Straps 10 are formed from hook and loop material (e.g., VELCRO®) in the embodiment shown. However, one of skill in the art will appreciate that the straps 10 could be formed from a variety of materials including leather, metal, an elastomeric material, plastic or some combination of materials. One end of the straps 10 is anchored on one side of the posterior shell 6 at fixed slots 12. The free end of each strap 10 is then stretched around the anterior shell 8 to a pair of strap guides 18. The free end of the strap 10 is passed through the pair of strap guides 18 and stretched around the remaining portion of the anterior shell 8. The free end of strap 10 passes through either an adjustable ring 20 or a buckle 22, shown in
Other configurations of PTB 4 will also work with this disclosure. For example, the posterior shell 6 and the anterior shell 8 may be connected by a wide variety of structures instead of straps 10, such as hinges, bands, latching mechanisms, interlocking tracks, locking mechanisms, buckles, ratchet systems, small cables, etc. The connection between posterior shell 6 and anterior shell 8 may also include bail and catch or ratcheting buckles to create a tighter fit. In another alternative, the posterior shell 6 and the anterior shell 8 may be integrally formed and there may be a slit in the PTB 4 to allow the leg to pass through before the edges of the slit are drawn together with laces or a zipper.
As can be seen in
The PTB 4 is held in place on the leg by tightening straps 10 such that the patellar bar 30 (also referred to as a “patellar tendon knob”) in the anterior shell 8 is pressed against the patient's patellar tendon, inferior surface of the patella and tightened to the calf. The patellar bar 30 is a protrusion in the anterior shell 8 of PTB 4. It is contemplated that PTB 4 may be held in place by other or additional structures such as a compressible foam liner or air bladders.
The exterior of PTB 4 may be formed from a rigid or semi-rigid material such as plastic, plasticized organic fabrics, etc. To improve user comfort, the interior surface 14 of the PTB 4 may be formed from a nonslip material to prevent rubbing and irritation to the skin and also a softer material, such as foam, fabric or a combination of softer materials. Vent holes 34 may be provided in the posterior shell 6. Further, the top edge of posterior shell 6 may be an arc 28 that dips below the back of the knee to avoid pinching the back of the leg when the user sits.
The second module of the orthopedic bracing system 4 is the walking boot 36, depicted in
The walking boot 36 includes a base 50 and an upper section 52. The base 50 and the upper section 52 may be integrally formed from plastic or other suitably rigid, lightweight materials. For example, the walking boot 36 may be formed from any rigid, hard durable material including plastic, metal, steel, aluminum, fiberglass, carbon fiber, composite material or any combination thereof. In another, non-limiting example, the walking boot 36 may also be formed from, e.g., polypropylene or polyethylene.
Alternatively, the upper section 52 of walking boot 36 may be formed by connecting rigid uprights to base 50. The uprights can be spaced apart from each other. For example, there may be one upright may be positioned near the heel of the user and additional uprights may be located on the lateral sides of the user's leg. The uprights may be formed from any rigid material, e.g., plastic or metal, e.g. steel. For example, the uprights may be formed from any rigid, hard durable material including plastic, metal, steel, aluminum, fiberglass, carbon fiber, composite material or any combination thereof. The uprights may also be formed from, e.g., polypropylene or polyethylene. Fabric may be stretched around the uprights to form an enclosure for the user's leg.
The base 50 of the walking boot 36 has a sole 44 made from elastomeric or rubber material with treads for better traction. The top surface of the base 50 is a broad, flat foot bed 42 that can accommodate a range of foot sizes. The foot bed 42 may be surrounded or partially surrounded by a sidewall 54 that extends vertically from the foot bed 42 to protect the sides of the foot. Optionally, the base 50 of the walking boot 36 may include straps 38 attached to sidewalls 54 by, e.g., rivets 48 as shown in
The upper section 52 of the walking boot 36 extends from the base 50 upward to approximately the proximal end of the patient's calf. It surrounds the posterior side and lateral sides of the patient's lower leg and is open on the anterior side. The upper section 52 of walking boot 36 may be secured to the patient's leg with, e.g., hook and loop straps 38. However, other attachment mechanisms are also contemplated such as snaps, buttons, hooks, latching mechanisms, buckles, ratchet mechanisms, small cables, etc. The straps 38 may be attached to the walking boot 36 by the same mechanisms discussed in relation to the straps 38 for base 50, or they may be attached using strap guides 46 as shown in
The walking boot 36 may include optional features for patient comfort, such as vent holes 40. It may also include a cover 39, as shown in
The AFO 60 is the third module of the bracing system, depicted in
The exterior shell 62 of AFO 60 is made from a material such as a rigid or semi-rigid plastic, such as for example, polypropylene, copolymers, polyethylene or any suitable plastic, that provides structure for stabilizing the foot and ankle. The interior of the AFO 64 can be made of a softer material for comfort such as fabric or foam, for example, the product sold under the trademark PLASTAZOTE®, manufactured by Zotefoams.
The base 66 of the AFO 60 is intended to accommodate a range of sizes. It may angle upward slightly at the toe 68. The arch 70 is shown flat such that the AFO 60 may be worn on either the right or left foot. It is also contemplated that the base 66 may include a curved arch 70 to provide additional support. A sidewall 72 extends upward from the arch 70 to the heel 74 to protect the instep of the foot. The heel 74 of the base is semi-spherical to accommodate the patient's heel.
The upright portion 76 of the AFO 60 extends upward from the heel 74. The upright portion 76 is curved to fit around the posterior portion of the lower leg. In the embodiment shown, the anterior side of the leg is exposed.
The AFO 60 may be secured to the patient's leg and foot using straps 78. The straps 78 may, by way of non-limiting example, be fastened with hook and loop, snaps, buttons, an elastomeric material, or any suitable material known in the art. The AFO 60 may also be secured to the foot and/or leg by some other device such as a bandage, a wrap, a sock or some combination of methods.
The AFO 60 may be a generic or universal fit that accommodates most foot sizes and shapes. It may also be easily molded, for example, in a healthcare professional's office, to provide a more secure fit without the need for an orthoptist or measuring. The AFO 60 may also be custom-made for the user. The AFO 60 may be reversibly attached to the walking boot 36, may rest on the footbed 42 of the walking boot 36 or may be suspended in the walking boot 36 with or without the use of a PTB 4.
The modules of the orthopedic bracing system 2 are designed to work in combination to provide the required level of stabilization, protection and offloading of the patient's weight.
In particular, as shown in
As can be seen in
It is further contemplated that the attachment mechanism 82, which attaches PTB 4 to walking boot 36, may be adjustable to allow the percentage of the patient's weight being borne by the user's foot and ankle to range from approximately 0%, as shown in
The foot bed 42 may also be adjustable. For example, it may be raised or lowered using a knob, or it might include a bladder than can be inflated or deflated. In another example, it may be configured to accommodate attachments, such as inserts, that would effectively raise the level of the foot bed 42.
In the same connection, the degree of hydrostatic compression created by the PTB 4 may also be adjustable. For example, the straps 10 of PTB 4 may be configured to apply a greater or lesser force to the user's leg. Alternatively, the PTB 4 may have an internal air bladder that may be inflated or deflated to adjust the compressive force of PTB 4 on the user's leg. In another alternative, a ratcheting buckle may be used to adjust the force.
When no longer needed, the PTB 4 can be removed from the walking boot 36. The user may continue to use the other modules of the orthopedic bracing system. For example, the AFO 60 may be used in combination with the walking boot 36 or the AFO 60 may be used with an ordinary shoe.
The AFO 60 may be configured to be releasably attached to the upper section 52 of the walking boot 36 at attachment region 84, as shown in a non-limiting embodiment in
The attachment between the AFO 60 and the walking boot 36 advantageously prevents movement of the AFO 60. This improves stability and reduces the risk of friction wounds.
When the walking boot 36 is used in combination with the PTB 4, as in
Alternatively, in a configuration of the orthopedic bracing system 2 that does not include a PTB 4, the AFO 60 may rest directly on the foot bed 42 of the walking boot 36 as shown in
Since the connection between the AFO 60 and the walking boot 36 is releasable, the patient can remove the walking boot, for example, when they are sleeping, sitting down or resting. The AFO 60 will continue to provide stability and proper positioning of the foot, just with a lower degree of protection from external forces, which is appropriate for activities such as sleeping or relaxing.
When the patient's recovery has progressed to the point where the walking boot 36 is no longer required, the AFO 60 may be removed from the walking boot 36 and used with an ordinary shoe. The AFO 60 can continue to provide stability and positioning for the foot and ankle, but without the extra structure of a full walking boot.
The particular structure and features of the brace assembly disclosed above can be better understood with regard to the following description of how the assembly is fitted onto a patient's foot/ankle and then adjusted to proportion the weight as desired.
The orthopedic bracing assembly 2 is donned by first attaching the AFO to the injured foot or ankle. The PTB 4, if needed, can be attached to the walking boot 36 and adjusted to a distance from foot bed 42 that can accommodate the user's height and can achieve the desired proportioning of weight bearing between the patellar region and the foot. It is possible, also, to adjust foot bed 42 to create the desired distance between PTB 4 and foot bed 42. For example, the foot bed 42 may be raised by attaching an insert on top of the foot bed 42. The foot bed 42 may also be raised using an inflatable bladder. In another alternative example, the foot bed 42 may be a platform that can be raised and lowered by turning a knob. The user's leg may be placed into the walking boot 36 and the AFO may then be attached to the walking boot 36. The anterior shell 8 of the PTB 4 may be adjusted such that the patellar bar 30 is in contact with the user's patellar tendon and the straps of the PTB 4 can be tightened. Finally, walking boot 36 may be secured to the leg.
A method for supporting an injured lower extremity can be provided using the disclosed orthopedic bracing system. In one embodiment of such a method, a first support member is attached to a region surrounding the patellar tendon and calf of the patient and a second support member is provided for an area at or beneath the sole of the foot of the injured leg. The first support member may, for example, be a PTB 4. A first upward force is provided on the patellar region and calf by the first support member. A second upward force is provided at the foot by the second support member. The second support member may, for example, be the foot bed 42 of the walking boot 36. The amounts of the first upward force and the second upward force can then be adjusted to a desired balance.
The adjustment in force may be made by changing the positions of the first and second support members. In particular, the adjustment may be made by changing the position of the attachment of the support members to an orthopedic walking boot.
In a further aspect of the method, a prescribed angle between the foot and leg may be maintained after the amounts of the first upward force and the second upward force are adjusted. The prescribed angle between the foot and leg can be maintained using an AFO 60. For example, when the first upward force makes up all or nearly all of the upward force, an AFO 60 can maintain the foot at the prescribed angle, rather than letting it dangle from the ankle.
In an exemplary method for supporting an injured lower extremity, a first support member is attached to a region surrounding the patellar tendon and calf of the injured patient and a second support member is provided for an area at or beneath the foot of the injured leg. In the example shown in
The upward force F is divided into two parts. A first upward force F1 can be applied in the area of the calf, the proximal tibial plateau and the patellar tendon with the first support member and a second upward force F2 can be applied to the foot by the second support member. The sum F of the first upward force F1 and the second upward force F2 will equal the downward force W from the weight of the user as the user walks or stands. Of course, the force W will vary during movement of the user such as walking and may at times exceed the weight of the user.
In the example shown in
The proportion of F1 and F2 to the total force F can be adjusted to a desired balance. For example, F1 may be from about 0% to about 100% of F and F2 may be from about 0% to about 100% of F. Within these ranges, F1 may be 100% of F, from 95-100% of F, from 90-95% of F, from 80-90% of F, from 70-80% of F, from 60-70% of F, from 50-60% of F, from 40-50% of F, from 30-40% of F, from 20-30% of F, from 10-20% of F, from 0-10% of F. F2 may be 0% of F, from 0-5% of F, from 5-10% of F, from 10-20% of F, from 20-30% of F, from 30-40% of F, from 40-50% of F, from 50-60% of F, from 60-70% of F, from 70-80% of F, from 80-90% of F, from 90-100% of F or 100% of F.
The proportion of F1 and F2 can be adjusted by changing the positions of the first and second support members. For example, as described above, PTB 4 can be attached at a lower position on walking boot 36 such that AFO 60 is in contact with the foot bed 42 of walking boot 36. Alternatively, as also discussed above, foot bed 42 of walking boot 36 may be raised such that it is in contact with AFO 60. The upward force F2 is primarily a function of how firmly the foot and AFO 60 contact the foot bed 42.
Unlike the foot bed 42, which provides a substantially horizontal surface that readily provides an upward force F2, the PTB may rely on a variety of features to provide the force F1. For example, as shown in
Another example of a structural feature that can contribute to the upward force F1 applied by the PTB 4 is shown in
Another example of a structural feature that can contribute to the upward force F1 applied by the PTB 4 is shown in
If an AFO 60 is used in connection with certain embodiments, such as
Several possible alternatives for adjusting F1 and F2 are disclosed above. The ability to adjust F1 and F2 over the course of a patient's recovery provides the advantageous capability of adjusting the percentage of a patient's weight being borne by the injured foot and ankle in a controlled manner.
Further details and features of the embodiment earlier described with reference to the walking boot 36 are shown in more detail in
The base 50 may be formed from a rigid, durable material such as metal or plastic. The metal or plastic may be covered with padding, e.g., foam padding, fabric or a combination of foam, fabric or other elastomeric material. The sole 51 may be formed from an elastomeric material, such as rubber. Straps 38 can be attached to the base 50 and used to attach the base of the walking boot 36 to the patient.
As shown in
The liner 41 may also have a slit 106 through which the rear upright 102 can slide. When the rear upright 103 passes through the slit 106 leading to the interior of the liner, as shown in
It is also possible to secure the bottom of the liner 41 to the base 50 of the walking boot 36 with, for example, VELCRO®, snaps, hooks or other suitable attachment mechanisms known in the art.
As shown in
Various methods of securing the liner around the patient's leg are possible. For example,
Additional optional features of the liner 41 are also shown in
In the example of
In the example of
In the example of
In the example of
The AFO 60 shown in
One of skill in the art will appreciate that various ways of attaching the AFO 60 to the walking boot 36 are feasible. For example, as shown in
In the example of
In the example of
Alternatively, as shown in
Alternatively, AFO 60 may be attached to walking boot 36 using a magnet 523. One possible placement of magnet 523 in the heel of base 50 is shown in
In the alternative shown in
Other configurations of continuous strap 908 are possible. For example, as shown in
An optional pneumatic device may be added to liner 41 to supply compression as the user's leg is healing. Various configurations of the pneumatic device are possible. For example, a self-inflating bladder, as shown in
One of skill in the art will appreciate that different configurations of valve 530 are possible. For example,
Other configurations of the pneumatic device will work with this disclosure. For example, the pneumatic device may be a pump built into the walking boot 36. A non-limiting example of such a pump is shown in
Another non-limiting example of a pneumatic device that will work with this disclosure is a hand inflation device such as the one shown in
One of skill in the art will appreciate that liner bladders may be configured in various ways, as shown in
Alternative braces will also work with the previously disclosed embodiments of orthopedic bracing system 2. For example, as shown in
Alternatively, as shown in
Rods 1306 and 1308 may be made from a light-weight material such as carbon fiber, aluminum or hollow tubes made from metal alloys. One of skill in the art will appreciate that alternate materials may be selected for heavier patients.
In such an embodiment, the patient's knee may also be held in a fixed position. For example, as shown in
Support 1304 may be adjusted to redistribute the force from the patient's weight between thigh, knee and foot. For example, in
Further, the angle of support 1304 relative to base 50 of walking boot 36 may be adjusted to allow greater or lesser amounts of weight to be borne by the patient's knee. Axis A3, shown in
In most embodiments contemplated herein, an AFO 60 is also detachably connectable to the walking boot 36 (AFO not shown in
Support 1304 may also be adjustable for size. Straps 1320 may be tightened or loosened to accommodate different size thighs. Further, first support portion 1303 of support 1304 may also be adjustable in length to accommodate longer or shorter legs. For example, first support portion 1304 may be extended as shown by dashed line 1322 in
The position of support 1304 relative to base 50 of walking boot 36 may also be adjusted. In the example shown in
Moreover, the sole 51 of walking boot 36 may be adjustable to different heights and angles. For example, wedges 1316 may be releasably attached to sole 51 such that a height of Hi is obtained in the heel of base 50 and, depending on the shape of wedge 1316, a height of H2 or H3 is obtained at the toe of base 50. Wedges 1316 may be attached to sole 51 and/or base 50 using plates and screws, adhesives, interlocking tracks, VELCRO®, or any other attachment means known in the art. Alternatively, the height of foot bed 42 may be adjusted by releasably attaching wedges 1316′ to foot bed 42. The density of the material used to make wedges 1316, 1316′ may also be variable, providing adjustable levels of compression as well.
The adjustability of the angles θ and β and the various heights and lengths that may be achieved by adjusting components of support 1304 allows orthopedic bracing system 2 to be fit to any patient such that the patient's hips remain essentially at the same height when walking. In existing non-weight bearing bracing systems, the patient's hip is pushed up when walking, which causes pain in the back and hips.
Support 1304 may replace PTB 4 in the preceding embodiments to reduce or eliminate the amount of weight normally borne on the patient's foot. Support 1304 may also be added to embodiments of this disclosure where PTB 4 is not shown. Just as PTB 4 is removable from orthopedic bracing system 2, support 1304 may be removed when the patient is able to bear his or her full weight on the foot.
While exemplary embodiments have been disclosed hereinabove, the present invention is not limited to the disclosed embodiments. Instead, this application is intended to cover any variations, uses, or adaptations of this disclosure using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.
This application is a continuation of International Application No. PCT/US21/49211, filed Sep. 7, 2021, which claims priority to U.S. Provisional Patent Application No. 63/108,314, filed Oct. 31, 2020, and U.S. Provisional Patent Application No. 63/074,514, filed Sep. 4, 2020, the entire disclosures of which are hereby incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63108314 | Oct 2020 | US | |
| 63074514 | Sep 2020 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US21/49211 | Sep 2021 | US |
| Child | 18177389 | US |
