SUMMARY
[0013]As discussed above, current orthopedic products require a clinician to remove the entire apparatus from the patient in order to inspect and treat wounds on the plantar surface of the patient's foot. While these devices provide improved patient compliance, they are also relatively expensive and time consuming to apply. Further, due to the requirement that the wounds be checked weekly, or sometimes daily, the repeated removal and application or reapplication of an orthopedic device also adds to the costs.
[0014]Accordingly, an orthopedic device or orthopedic footwear in the form of an off-loading walkers or low top boots, generally referred herein as "diabetic walker," with removable or detachable bases and/or sole areas that allow the inspection and treatment of the plantar surface of the foot are proposed. There are two main components of the diabetic walker: the base/sole and strut. The base/sole component is the area that surrounds and supports the foot when the walker is in use. The strut component involves the strapping system or any apparatus used to secure the leg to the strut(s) to immobilize the leg.
[0015]In order to allow a clinician easy access to the plantar surface of the foot, the diabetic walker has a movable or a removable/detachable base and/or sole area that allows the practitioner access to the plantar surface of the foot without requiring removal of the strut component from the patient's leg. In other words the strut component remains on the patient's leg when the base/sole area is removed. Thus, the clinician is not required to completely remove and replace or to remove and reapply the orthopedic device. Accordingly, the time required for each patient visit can be greatly reduced, as well as reducing the costs associated with the treatment.
[0016]In further details of disclosed embodiments, there may be locking mechanisms to hold the base/sole area to the strut area when the off-loading walker is in use. A release mechanism may be incorporated with or may be separate from the locking mechanism in order to aid with removal or detachment of the two areas. Appropriate locking mechanisms may be provided on both the walker and the sole assemblies so that the patient may not remove either without a practitioner or physician present.
[0017]Exemplary embodiments may include an off-loading walking boot that has a sole or bottom portion that hingedly detaches or swivels away from the plantar aspect of the foot to allow visual inspection and dressing changes. Alternatively, an off-loading walking boot may include a sole or bottom portion with a sliding window section for viewing and treating the plantar surface of the foot. In yet another alternative, a pattern of fiberglass composite material may be formed into the shape of a lower leg cast that contains a removable section for visualizing the plantar surface of the foot.
[0018]A number of embodiments of orthopedic devices in the form of orthopedic devices, diabetic walkers and footwear with easy access to a wound site are disclosed herein to provide an improved orthopedic device that alleviates or eliminates the above described and other shortcomings of the previous orthopedic devices for treating plantar ulcerations and other foot injuries. These embodiments include improvements in the structure and use of diabetic footwear in the form of an off-loading walking boot that allows the physician or practitioner to have access to the plantar surface of the patient's foot without having to completely remove the orthopedic device. Further, the structures may include retaining mechanisms that prevent unauthorized removal of the device or unauthorized access to the plantar surface of the foot.
[0019]In accordance with one embodiment of the invention, an orthopedic device includes at least one strut member extending from a base portion. The strut member is secured to the patient's limb utilizing appropriate mechanisms, such as straps having hook and loop fasteners. Additional structure, such as a retaining strap, may be provided in order to prevent the unauthorized removal of the orthopedic device.
[0020]A sole portion is provided along a distal portion of the base portion for providing the walking surface of the orthopedic device. An insole or cushion is positioned along the sole portion and the base portion and to define the contact surface for contacting the plantar aspect of a foot. Alternatively, the insole or cushion may be integral with or defined by the sole portion. The sole portion is movable with respect to the base portion in order to allow access to the plantar aspect of the foot.
[0021]In a variation, the sole portion is attached to the base portion at a rotatable connection, such as a swivel rivet, a swing hinge, or a living hinge. In a further variation, a guide slot is provided in the base portion that engages a guide pin that is connected to the sole portion in order to provide a smooth opening between the sole and base portions.
[0022]In a variation, the rotatable connection between the base and the sole is positioned in a posterior portion of the sole portion and a posterior portion of the base portion in order to allow the sole portion to swing or rotate away from the base portion.
[0023]In another embodiment, a locking mechanism is provided for allowing selective movement of the sole portion and maintaining the sole portion in position during use. The locking mechanism includes a first portion positioned in a posterior portion of the sole portion. The locking mechanism also includes a second portion correspondingly positioned in a posterior portion of the base portion. The first and second portions are engageable and disengageable, wherein the locking mechanism prevents movement of the sole portion when the first and second portions are engaged.
[0024]As an alternative, the locking mechanism has a first portion positioned in an anterior portion of the sole portion and a second portion correspondingly positioned in an anterior portion of the base portion. The first and second portions are engageable and disengageable, wherein the locking mechanism prevents movement of the sole portion when the first and second portions are engaged.
[0025]In a variation, a slidable latch member is provided on a posterior portion of the base portion and a corresponding housing member for receiving the latch member is provided on a posterior portion of the sole portion.
[0026]In a further variation of the invention, at least one first locking mechanism has a first portion positioned along a lateral side of the sole portion and a second portion correspondingly positioned along a lateral side of the base portion. At least one second locking mechanism has a first portion positioned along a medial side of the sole portion and a second portion correspondingly positioned along a medial side of the base portion. The respective first and second portions are engageable and disengageable, wherein the locking mechanisms prevent movement of the sole portion when the first and second portions are engaged.
[0027]In a further variation of the movable sole, the sole portion is removably connected to the base portion in order to allow removal of the sole portion without causing any damage to the plantar surface of the foot. In this variation, a latch member is provided on a posterior portion of the base portion and a corresponding housing member is provided on a posterior portion of the sole portion for receiving the latch member. At least one slide member is provided along anterior, lateral and/or medial edges of the distal portion of the base portion. The slide member removably engages at least one corresponding guide channel provided along anterior, lateral and/or medial edges of a proximal portion of the sole portion in order to allow the sole portion to be slidably removable from the base portion.
[0028]In an alternative construction, at least one slide member is provided along anterior, lateral and/or medial edges of the distal portion of the base portion. The slide member removably engages at least one corresponding guide channel provided along anterior, lateral and/or medial edges of a proximal portion of the sole portion. This variation provides increased contact area between the connections of the sole and base portions in order to provide an improved fit.
[0029]In a variation, the base portion has a stop member positioned on an anterior portion of the distal portion of the base portion in order to retain the sole member in a predefined position on the base portion. Alternatively, a cut-out portion is provided in the base portion that is complementary shaped to a raised portion of a proximal surface of the sole portion.
[0030]In an alternate configuration of the removable sole, at least one clip member is provided along lateral and/or medial edges of the distal portion of the base portion. The clip member removably engages at least one corresponding recess provided along lateral and/or medial edges of a proximal portion of the sole portion. The at least one clip member extends distally from the distal portion of the base portion and has an anterior or posterior extending portion received in a respective anterior or posterior extending portion of the corresponding recess. Thus, the plantar surface of the foot may be accessed while the orthopedic device is retained on the user's limb.
[0031]In another configuration, the base portion includes at least one posterior lock member along the distal portion of the base portion and at least one slide lock member along a lateral or medial side of the base portion. The posterior lock member removably engages a slot portion along a posterior portion of the sole portion and the slide lock member removably engages a slot portion along a lateral or medial side of the sole portion in order to allow selective removal of the sole portion from the base portion.
[0032]In another embodiment of the present invention, an orthopedic device has at least one strut member removably connected to and extending from a base portion. A sole portion is positioned along a distal portion of the base portion. An insole or cushion member is positioned along or defined by the sole portion and is positioned along the base portion and defines the contact surface for contacting the plantar aspect of a foot. The sole portion and the base portion are movable with respect to the strut member for providing access to the plantar aspect of a foot. A locking mechanism has a first portion positioned on a proximal portion of the base portion and a second portion positioned on a distal portion of the strut member. The first portion of the locking mechanism is a raised portion and the second portion of the locking mechanism is a recessed portion. Alternatively, the first portion of the locking mechanism may be at least one recess and the second portion of the locking mechanism may be at least one projection.
[0033]In a variation, the orthopedic device includes opposed lateral and medial strut members extending from opposed lateral and medial base portions. A sole portion is positioned along a distal portion of each base portion. An insole or cushion member is defined by the sole portion or positioned along the sole and base portions and defines a contact surface for contacting the plantar aspect of a foot. The sole portion is selectively removable from the lateral and medial base portion for providing access to the plantar aspect of a foot. At least one extension member extends from each of the distal portions of the lateral and medial base portions and is received within a recess formed along respective lateral and medial sides of the sole portion. Each extension member has a ratchet surface and selectively engages a ratchet mechanism within the respective recess. This configuration allows the sole to be easily removed from the base portions and struts, thus allowing access to the plantar surface of the foot without removing the device form the patient's limb.
[0034]In another variation, the orthopedic device includes an anterior shell and at least one posterior shell having at least one locking mechanism with a first portion carried by the anterior shell and a second portion carried by the posterior shell. A sole portion is positioned along a distal portion of the anterior shell. An insole or cushion member is positioned along the sole and defines the contact surface for contacting the plantar aspect of a foot. The sole portion is selectively removable from the anterior shell for providing access to the plantar aspect of a foot. At least one strut member extends between a proximal and a distal posterior shell. The height of the strut member and the proximal and distal posterior shells is adjustable in order to provide a proper fit for user's of different sizes.
[0035]In an alternate embodiment of the inventions, an orthopedic device includes a support for the lower leg that is open at a distal end thereof. A retaining member is provided along the distal end of the support and defines an opening between anterior, lateral, posterior, and medial sides of the retaining member. A removable sole member having a projecting portion selectively engaging a lip portion is provided within the opening. A locking mechanism has a first portion positioned on the sole member and a second portion positioned on the retaining member. Thus, the plantar surface of the foot may be accessed by simple removal of the sole portion, while the support remains on the patient's limb.
[0036]In a variation, the orthopedic device includes a support for the lower leg that is open at a distal end thereof. A retaining member is received within and occluding the open distal end of the support and has at least one tab protruding from a distal surface thereof. A removable sole member has at least one passage corresponding to the protruding tab. At least one locking peg passes through the corresponding passage and selectively engages the corresponding protruding tab. The protruding tab includes a flared end selectively engaging a corresponding locking protrusion on the locking peg in order to retain the sole portion in position when in use.
[0037]In an alternate construction, the orthopedic device includes a support body defining a clip member slot on a distal surface thereof. A removable sole member has a clip member selectively engaged with the clip slot.
[0038]In a further variation of a rotatable or pivotable sole, an orthopedic device has at least one strut member secured to at least one base portion through a pivotable hinge. The orthopedic device also has a sole portion attached to or integrally formed with the base portion. Thus, the sole portion is pivotable with the base away from the plantar surface of the foot in a manner that allows a physician to inspect and treat the plantar surface of the foot, as well as a portion of the ankle.
[0039]Numerous variations of a retaining strap are disclosed. The variations of the retaining strap may be utilized with any of the variations or embodiments of the diabetic footwear described herein. The retaining straps provide varying degrees of restricted access or removal of the orthopedic device depending upon the level of patient compliance that a physician expects from a particular patient.
[0040]The numerous advantages, features and functions of the various embodiments of an orthopedic device with easy access to a wound site will become readily apparent and better understood in view of the following description and accompanying drawings. The following description is not intended to limit the scope of the orthopedic device with easy access to a wound site, but instead merely provides exemplary embodiments for ease of understanding.
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