Patent ID: 12213903

The drawing figures are not necessarily drawn to scale. Instead, they are drawn to provide a better understanding of the components and are not limited in scope, but to provide exemplary illustrations. The figures illustrate exemplary configurations of an orthopedic device, and in no way limit the structures or configurations of an orthopedic device and components according to the present disclosure.

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS

A. Introduction

Embodiments of a positioning wedge are provided for postoperative or post-injury suspension or propping of a limb relative to a body portion. In the following embodiments, the positioning wedge is described in the context of an abduction pillow for a shoulder such that the positioning wedge offloads the shoulder at a predetermined angle. The positioning wedge can be adapted to other indications, including a hip-abduction pillow. The positioning wedge is not necessarily solely adapted to suspend or prop a limb relative to a body portion. Still, it may be used against a non-body surface to suspend or prop a limb, such as a bed or other surface, in elevating a limb at a predetermined angle.

Although the embodiments of the disclosure are adapted for supporting and stabilizing anatomical portions of many users having various anatomical shapes and sizes, the embodiments of the disclosure may also be dimensioned to accommodate different types, shapes, and sizes of anatomical portions.

A better understanding of different embodiments of the disclosure may be had from the following description read with the accompanying drawings in which like reference characters refer to like elements. While the disclosure is susceptible to various modifications and alternative constructions, certain illustrative embodiments are in the drawings described below. It should be understood, however, there is no intention to limit the disclosure to the embodiments disclosed, but on the contrary, the intention covers all modifications, alternative constructions, combinations, and equivalents falling within the spirit and scope of the disclosure. Unless a term is defined in this disclosure to possess a described meaning, there is no intent to limit the meaning of such term, either expressly or indirectly, beyond its plain or ordinary meaning.

Reference characters are provided in the claims for explanatory purposes only and are not intended to limit the scope of the claims or restrict each claim limitation to the element in the drawings and identified by the reference character.

For ease of understanding the disclosed embodiments of a positioning wedge, the term superior is used to exemplify a position or range of positions above something or to approach such above something; an example would be towards or at a top of the positioning wedge is arranged in an upright manner as shown inFIG.1. The term inferior is used to exemplify a position or range of positions below something or approaching such below something; an example would be towards or at a bottom if the positioning wedge is arranged in an upright manner, as shown inFIG.1. While the wedge may be positioned sideways, upside down, or skewed for various uses, the terms superior and inferior are used in the context of the positioning wedge in an upright position, as illustrated.

The term longitudinal is used generally in the aforesaid upright manner, whereby longitudinal conveys relating to length, as in inferior to superior. The term lateral is used relative to longitudinal and conveys relating to the side or side to side, generally perpendicular to longitudinal, accounting for uneven and rounded possible surfaces.

The terms “rigid,” “flexible,” “compliant,” and “resilient” may be used herein to distinguish characteristics of portions of certain features of the positioning wedge and associated devices and components. The term “rigid” should denote that an element is generally devoid of flexibility. Within the context of components that are “rigid,” it should indicate that they do not lose their overall shape when force is applied. The term “flexible” should denote that features are capable of repeated bending. The features may be bent into retained shapes or the features do not retain a general shape but continuously deform when force is applied. As for the term “semi-rigid,” this term is used to connote properties of components that provide support and are free-standing; however, such components may have flexibility or resiliency.

The term “compliant” is used to qualify such flexible features as generally conforming to the shape of another object when placed in contact therewith, via any suitable natural or applied forces, such as gravitational forces, or forces applied by external mechanisms, for example, strap mechanisms. The term “resilient” is used to qualify such flexible features as generally returning to an initial general shape without permanent deformation. The term “compressible” may qualify such structural features as being capable of being reduced in size or volume due to the exertion of force applied to the structural feature.

B. Embodiments of the Positioning Wedge

FIG.1exemplifies a positioning wedge100arranged as an interface between two anatomical or body portions10,20of a human body to arrange the two anatomical portions10,20at a predetermined angle A relative to one another. In this instance, the positioning wedge100abuts a torsal region or body, as a first anatomical portion,10of the user and props up the shoulder by positioning the arm or limb, as a second anatomical portion,20at an angle or among angles A relative to the torsal region10. The positioning wedge100may be configured with a shoulder immobilizer and/or arm apparatus disclosed in the co-owned U.S. provisional application No. 62/925,057 filed on 23 Oct. 2019, having the title “Shoulder Immobilizer and Arm Apparatus.”

The positioning wedge100includes a main body102with first and second sides104,106arranged adjacent to the body10, and the limb20, respectively. At least one insert116,118is arranged between the first and second sides104,106at a predetermined angle associated with a shape of the at least one insert116,118. The positioning wedge100is modular in that it can be configured to position the first and second sides104,106relative to one another among different angles.

In the depicted example, the first and second sides104,106correspond to or define actual angular profiles108,110; however a profile itself may comprise the first and second sides104,106, if one of the discrete angular profiles108,110is removed. Each angular profile108,110itself may define the first and second sides104,106, and may correspond individually to an angular relationship among the first and second sides104,106, however in the illustrated example, the first and second sides104,106correspond to discrete first and second angular profiles108,110, respectively. Preferably, the angular profiles108,110, and inserts116,118define a wedge-like shape. The wedge-like shape may have a superior end having a different lateral width relative to an inferior end along a longitudinal line from the superior end S to the inferior end I. The wedge-like shape defines the angular profile in that it is arranged to articulate or arrange the first and second anatomical portions of a human body at an angle, and such angular profiles may be combined to construct other angular configurations aside from the angular profile of a given single wedge-like shape.

Referring to the illustrated embodiment ofFIGS.1-4, the at least one insert116,118is detachable from the main body102to configure the positioning wedge100into different angles. In the example, the at least one insert116,118comprises first and second inserts116,118arranged to be inserted individually or collectively between the first and second sides104,106. The first insert116is arranged with a first insert profile117configured to arrange the first side104relative to the second side106at a first insert angle126. The first insert profile117has a wedge-like shape, such as a triangular shape or other suitable shape corresponding to a predetermined angle along its longitudinal length, with an end portion127extending to a superior clearance120and a bridge portion103between the first and second sides104,106at the predetermined angle126.

The first and second inserts116,118preferably interlock with one another and interlock with the first and second sides104,106. Likewise, when the first and second sides104,106remain adjacent to one another without the first and second inserts116,118located therebetween, the first and second sides104,106preferably interlock with one another to prevent separating from one another. By usage of the term interlock, it means securing within one another in a fixed position, with means provided on each interlocking part to cooperate with one another to unite and prevent separating from one another, without generally intentionally doing so.

The first and second sides104,106are continuously connected to one another by the bridge portion103, meaning that the first and second sides104,106are unitary with the bridge portion103. The unitary construction allows for the first and second inserts116,118to be removed from the wedge100as separate parts relative to the unitary construction of the first and second sides104,106, and the bridge portion103.

Like the first insert116, the second insert118is arranged with a second insert profile119configured to arrange the first side104relative to the second side106at a second insert angle128. The second insert profile119has a wedge-like shape, such as a triangular shape, with an end portion129extending to the superior clearance120and the bridge portion103extending thereover between the first and second sides104,106at a predetermined angle126.

The first and second inserts116,118are arranged to be positioned between the first and second sides104,106, and orient the first and second sides104,106at an angle corresponding to a combined angle formed by the first and second inserts116,118. As illustrated, the first and second insert profiles117,119are identical to one another, however, the first and second insert profiles117,119may be different from one another, namely by their corresponding angles or shapes126,128. The positioning wedge100is not limited to just two inserts, but the bridge portion103may accommodate more or fewer than two inserts, with each insert corresponding to its own predetermined angle.

The provision of the bridge portion103between the first and second sides104,106advantageously facilitates easy and intuitive insertion of the first and second inserts116,118(or fewer or more inserts as desired) by providing a flexible and accommodating space in which the inserts116,118can be received, but without requiring a cumbersome or confusing insertion/removal procedure. Nevertheless, the main body102provides an intuitive and highly repeatable process for consistently correct insertion and removal of the inserts116,118, thereby addressing the problem of existing devices that do not have a mechanism for consistently correct addition or removal of incremental wedge segments.

Additionally, by providing the first and second sides104,106defining angular profiles108,110, the positioning wedge100defines body-conforming portions (such as the recesses112,114) that provide a comfortable and intuitive engagement with a user while also allowing the use of uniformly shaped, modular inserts for incrementally customizing the cumulative angle of abduction provided by the positioning wedge100as suitable based on an individual user's dimensions and rehabilitation progress.

The main body102may be formed continuously as a monolithic object from the same material, including the first and second sides104,106, and the bridge portion103. The inserts116,118may likewise be formed of the same material as the main body102. Alternatively, the bridge portion103may be formed from a different material compared to the first and second sides104,106, and may be removably connected to them. For example, the first and second sides104,106may be formed from foam or of a resilient and compressible material such as EVA (ethylene vinyl acetate), and the bridge portion103could be a textile connecting to the first and second sides104,106. The inserts116,118could be formed from the same or different materials from the first and second sides104,106, and may be selected among materials for properties including compressibility, resiliency, flexibility, rigidity, or semi-rigidity.

The bridge portion103may be defined as a flexible segment of the material of the main body102or a separate material, extending between the first and second sides104,106and arranged to permit the first and second sides104,106to articulate relative to one another in setting the predetermined angle A of the positioning wedge100. The bridge portion103may be a thinned segment and arranged to extend over none, one, or both of the first and second inserts116,118depending on the predetermined angle A of the positioning wedge100. For instance, the first and second sides104,106of the positioning wedge100may be configured with a predetermined abduction angle if no inserts are provided, allowing a user or clinician to step-down treatment to a minimal level of abduction as needed, such as during the later stages of rehabilitation of a shoulder post-operation.

As illustrated inFIGS.2and3, the first side104includes a first angular profile108defined as a cross-sectional portion of the main body102, and the first angular profile108is arranged at an angle relative to the second side106. While the first angular profile108may define a wedge-like or triangular shape articulating the first side104relative to the second side106at the bridge portion103, the first angular profile108forms a predetermined angle122relative to the second side106. A first protruding portion105may extend outwardly from the first angular profile108a first distance D1 from the first angular profile108. A first recess112extends from the first side104a first depth at a third distance D3 at or short of the first distance D1.

The first recess112may be adapted to accommodate at least one of the first and second body portions10,20. The first recess112can extend a distance113away from an edge115or opposed edges115of the first angular profile108such that the first angular profile108generally maintains a consistent lateral profile without interruption from the first recess112. The first recess112may generally extend superiorly S and inferiorly I of the main body102. The first recess112tapers superiorly S relative to inferiorly I such that the first recess112flares toward opposed edges115of the first side104inferiorly I.

As with the first side104, the second side106includes a second angular profile110defining a cross-sectional portion of the main body102. The second angular profile110is arranged at an angle relative to the first side106. The second angular profile110defines a wedge-like or triangular shape articulating the second side106relative to the first side104at the bridge portion103. The second side106defines a second recess114adapted to accommodate at least one of the first and second body portions10,20.

As an example as to how the recesses112,114along the first and second sides104,106may be adapted to an intended purpose of the positioning wedge100, the second recess114is shown as defining a profile121extending laterally at a superior portion of the second side106. The second angular profile110may form a predetermined angle124relative to the second side106. The second recess114is located at a superior portion of the second side106and directly extends from the bridge portion103.

FIG.4illustrates the first or second sides104,106, as defining an inner surface130arranged adjacent to an inner surface132of one of the first and second inserts116,118. The inner surface130of the first or second sides104,106is arranged to removably secure the inner surface132of one of the first and second inserts116,118. Removal or addition of one of the first and second inserts116,118correspondingly adjusts the angle A between the first and second sides104,106.

The inner surface130includes a fastener134engageable with a corresponding fastener136of the inner surface132. The fasteners134,136may be selected from among at least hook-and-loop material, snaps, interlocking portions of the inner surfaces130,132such as a tongue-and-groove arrangement or a protrusion and corresponding recess, and other suitable means to secure one of the inserts116,118to one of the sides104,106during extended use of the positioning wedge100. The inner surface132and corresponding fasteners136may be defined on either or both sides of the first and second inserts116,118, and can be arranged to cooperate with an adjacent insert or the opposite first and second sides104,106. Thus, when only a single insert116,118is needed to provide a desired angle of abduction, the single insert116,118is enabled to releasably secure to both the first and the second sides104,106to ensure reliable functionality of the positioning wedge100.

FIG.5shows another embodiment of a positioning wedge200comprising a first side204connecting to a second side206by a bridge portion203located at a superior side of a main body202. The first side204defines a first profile208, and the second side206defines a second profile210. The first and second sides204,206have interlocking inner surface profiles209,211. In this embodiment, the interlocking inner surface profiles209,211are defined by tongue218and groove216portions extending along with the first and second profiles208,210of the first and second sides204,206, and corresponding to interlocking portions213,215of first and second inserts212,214so that any of the preceding portions can removably connect to one another.

A clearance220is preferably defined between the bridge portion203and superior end portions217,219of the first and second inserts212,214. The clearance220is arranged to permit removal and addition of the first and second inserts212,214between the first and second sides204,206.

FIG.6illustrates another embodiment of a positioning wedge250. The main body252continuously forms the first and second sides254,256, and the bridge portion253is between the first and second sides254,256about the superior end of the main body252. The first profile258of the first side254continuously extends about the inferior end by a first inferior bridge portion270to a first insert262. A first inferior opening268is bounded by the first inferior bridge portion270and the first profile258. The first insert262extends continuously about a second superior bridge portion273nested inferiorly from the first bridge portion253.

A first superior clearance272is located between the first and second superior bridge portions253,273. A second insert264extends from the second superior bridge portion273inferiorly and is located adjacent a second profile260defined by the second side256. A second superior opening278is bounded by the second superior bridge portion273and the first and second inserts262,264. A second inferior bridge portion275extends continuously from the second insert264to a third insert266, extending superiorly to below the second superior opening278. A gap276is formed between the first and second inserts262,264, and superiorly of the third insert266. A second inferior opening274is bounded by the second inferior bridge portion275and the second and third inserts264,266.

The positioning wedge250defines a plurality of tear-away zones271located between each of the inserts262,264,266, and profiles258,260to quickly facilitate sizing of the positioning wedge250. The tear-away zones271may comprise thinned or perforated areas facilitating removal of inserts or profiles from one another. Alternatively, the tear-away zones271may comprise fasteners of any suitable variety such as hook-and-loop fasteners for releasably connecting and/or removing the inserts262,264,266. While the depicted embodiment shows three inserts262,264,266, it will be understood that fewer or more inserts may be provided as deemed suitable.

A first angular indicia280is located only on the first and second profiles258,260, representing an angle formed only by combining the first and second profiles258,260. A second angular indicia282is located only on the first and second profiles258,260, and the first and second inserts262,264, representing an angle formed only by combining the first and second profiles258,260and the first and second inserts262,264. A third angular indicia284is located only on the first and second profiles258,260and the first, second, and third inserts262,264,266, representing an angle formed only by a combination of the first and second profiles258,260, and the first, second and third inserts262,264,266, facilitating intuitive and effective sizing of the positioning wedge250by a clinician or a user.

FIGS.7A-7Dillustrate another embodiment of a positioning wedge300. The main body302defines at least one lateral slot316extending through at least one of the first and second sides304,306, and/or between one of the first and second sides304,306, and at least one of the first and second inserts308,310. In the depicted embodiment, it is preferred that the at least one lateral slot316primarily or solely extends through one of the first or second sides304,306and the corresponding profiles305,307since it may be likely that the positioning wedge300will maintain both the first and second sides304,306whether or not inserts are located therebetween. Multiple lateral slots may be provided in any of the profiles or inserts according to desired strapping configurations. At least one lateral slot316may facilitate attachment to components such as straps of a cooperating device as a shoulder immobilizer or sling.

The at least one lateral slot316is arranged for receiving at least one elongate strap317extending laterally through opposed lateral sides of the positioning wedge300. The at least one lateral slot316is depicted as being defined through at least part of the second profile307of the second side306since the second side306may cooperate with a strapping assembly for a shoulder or at least maintains the positioning wedge300in a fixed location about a user's torso.

The main body302may define at least one longitudinal slot318extending through the first profile305of the first side304. The at least one longitudinal slot318may extend arcuately through the first profile305. The at least one longitudinal slot318may define at least two slots319a,319bopening along a face309of the first side304, and extending through a thickness of the first side304. The at least one longitudinal slot318may also serve as a conduit for ventilating the main body302, with complimentary slots extending at least through the second side304, and/or the inserts308,310. In alternative embodiments, the at least one longitudinal slot318may be arranged to cooperate with straps or components of other devices, such as an arm apparatus, as described in greater detail below. For instance, the at least one longitudinal slot318may be configured to receive a strap that extends around the body portion to form a circumferential engagement between the positioning wedge300, the strap, and the body portion.

The at least one lateral slot316may define at least one hook portion330a,330bon opposed ends thereof. The at least one hook portion330a,330bgenerally extends along a height of the at least one slot316. A clearance328is preferably defined between the at least one hook portion330a,330b.

FIGS.7C and7Dshow how a ventilation feature324on the second side306corresponds to the pair of slots318a,318bon the first side304. The ventilation feature324and the pair of slots318a,318bextend through an entirety of the first and second profiles305,307. The ventilation feature324may extend over a substantial entirety of a longitudinal length of the second side306, and includes a plurality of ventilation slots326formed through a thickness of the profile307of the second side306and defined by a corresponding plurality of transverse ribs325. The first side304be arranged with a similar ventilation feature as the second side. Among the plurality of ventilation slots326, at least two ventilation slots326a,326bmay be arranged to receive a strap342configured for being wrapped thereabout.

The ventilation feature324may define a relief322on an outside surface of the second side306corresponding to a shape of the truncal region of the body, thereby minimizing the overall profile of the positioning wedge300and providing improved fit and comfort. For instance, the ventilation feature324including the ventilation slots326defined by the transverse ribs325may be recessed a distance D7 from the outermost surface of the second side306.

The second profile307may have thickness variations348to bolster a thickness of the profile307and have a corresponding tongue344arranged to interlock with a groove346defined by an inner lateral surface of the first profile305. When interlocked, the tongue and groove344,346engage sufficiently to avoid the first and second sides304,306from separating, however, due to a preferred resiliency of a material forming the positioning wedge300, a user or clinician can separate the first side304from the second side306by squeezing or otherwise manipulating the tongue and groove connection344,346to separate the first and second sides304,306. The ventilation feature324may also define a relief350on an inner surface of the second side, with a number of the ventilation slots326extending through the thickness of the profile307being spaced a distance laterally apart from an innermost section of the inner surface, i.e., at the tongue344. In this manner, the ventilation feature324defines sufficient space for air and heat transfer away from the user's body portion to occur through the spaces defined by the plurality of ventilation slots326.

The first side304defines a contoured recess314formed along the face309and is configured and dimensioned to receive an arm apparatus320, for example, an arm apparatus as described in greater detail in the aforementioned co-owned U.S. provisional application No. 62/925,057. The contoured recess314is form-fitted to an exact configuration of a side of the arm apparatus320. The contoured recess314can be adapted or formed for other devices or a general profile of an arm to hold an arm better close thereto. A fastener315may be located within the contoured recess314for securing to a corresponding fastener on the arm apparatus320. The arm apparatus320may have any suitable configuration or material (including compliant slings, rigid arm braces, and otherwise), and the contoured recess314likewise may define any suitable configuration to cooperate therewith. A material of the positioning wedge main body302proximate the contoured recess314may be formed from a material of increased softness, breathability, or compliance relative to a remainder of the main body302to softly cushion a user's arm, for instance, if no corresponding arm apparatus320is provided.

The contoured recess314is not limited to the shape described herein but may be adapted to different sizes and shapes, depending on the indication for which the wedge is used. An advantage of a contoured recess, as opposed to a generic recess, is that it enables the wedge to cradle an anatomical portion and/or apparatus secured to the anatomical portion of a user. This same desirability of the contoured recess, or any other body-conforming portions, allow the wedge to cradle and support anatomical portions, such as those that are opposing one another.

The main body302may include a clearance312formed along a superior bridge303connecting the first and second sides304,306, and providing access to superior ends of the first and second inserts308,310.

Referring toFIGS.8A and8B, an inner surface334of at least one of the first and second sides304,306defines at least one opening340arranged for receiving a fastener insert332. The fastener insert332includes a fastener element336and a mount338adapted to secure to the at least one of the first and second sides304,306by the at least one opening340. First and second fastener inserts332a,332bare defined, for example on an inner surface334of the second side306.

While the fastener inserts are shown as hook and loop fasteners, alternative fasteners may be used to secure parts and sides of the wedge together. For example, corresponding “mushroom” type snaps or fasteners may be provided on certain sides and sections, for insertion into corresponding an inner surface profile, such as an opening, enabling the mushroom type snaps to couple with the side or insert carrying the openings. Using such snap fasteners, whether a mushroom type or other known type of interlocking fastener, enables a clinician to snap in and maintain the wedge together, including parts and sides, together firmly. A balance between harder snaps for possible better retention, and softer snaps for possible better comfort, can be considered when selecting the fasteners.

In a variation of the positioning wedge300with first and second sides304,306rotated superiorly to expose first and second inserts308,310as shown inFIGS.7E-7F, an additional ventilation feature is provided in the first and second inserts308,310. The first and second inserts308,310may define first and second ventilation spaces362,364, respectively, configured to facilitate transfer of air and heat between and away from the body portions10,20supported and positioned by the positioning wedge300.

The first and second ventilation spaces362,364may comprise a substantial entirety or a majority of an interior portion of the first and second inserts308,310, such that remaining first and second outer bevels366,368, respectively, remain and space the first and second inserts308,310by a desired degree from the first and second sides304,306. The provision of the first and second ventilation spaces362,364advantageously improves ventilation and heat transfer (as air and heat are enabled to transfer much more freely through the resulting open space within the positioning wedge300), reduces the weight of the positioning wedge300, and avoids sacrificing the needed structural strength of the overall positioning wedge300due to the provision of the bevels366,368.

It will be appreciated that the depicted embodiment is merely exemplary, and the ventilation spaces362,364may take any suitable structure or form. For example, the first and second inserts308,310may alternatively comprise a material having greater porosity than the main body302. The first and second inserts308,310may define a ventilation feature324with ventilated slots326defined by a plurality of ribs. The ventilated slots326defined by the ventilation feature of the first and second inserts308,310may align with each other and with the ventilated slots326a,326bof the main body302, or may be staggered relative to the ventilated slots of adjacent structures, for example to reduce an overall profile of the positioning wedge300, to provide additional structural support, or otherwise.

The ventilation feature is not limited to elongate slots, as shown, but may include round openings or any other shape suitable for offering ventilation and reducing bulk of the wedge. Any of the slots or shapes of openings may be repurposed for insertion of straps or belts of any type described herein.

By providing a positioning wedge according to the disclosure's embodiments, the problem of existing foam blocks and other positioning devices being imprecise, cumbersome to use, poorly ventilated, and poorly configured for attachment to complementary and cooperating devices such as immobilizers and limb apparatuses is addressed. The positioning wedge of the disclosed embodiments advantageously provides an improved positioning wedge that can be configured for use between any suitable body portions and provides a customizable, intuitive, and effective solution for providing the desired level of support and unloading of a particular body portion.

While the disclosure discusses embodiments for the shoulder, positioning wedge embodiments of the disclosure may be used with other limbs, joints, and anatomical portions, including the torso, shoulder, elbow, wrist/hand, hip, knee, and foot/ankle, and including between any suitable body portion and any suitable structure, such as to provide abduction or unloading of a shoulder or hip relative to a bed, a chair, a couch, or any other surface.

Not necessarily all such objects or advantages may be achieved under any embodiment of the disclosure. Those skilled in the art will recognize that the disclosure may be embodied or carried out to achieve or optimize one advantage or group of advantages as taught without achieving other objects or advantages as taught or suggested.

The skilled artisan will recognize the interchangeability of various components from different embodiments described. Besides the variations described, other known equivalents for each feature can be mixed and matched by one of ordinary skill in this art to construct a positioning wedge under principles of the present disclosure. Therefore, the embodiments described may be adapted to systems for securing, supporting, or comforting limbs or another anatomical portion.

Although a positioning wedge has been disclosed in certain preferred embodiments and examples, it will be understood by those skilled in the art that the present disclosure extends beyond the disclosed embodiments to other alternative embodiments and/or uses of the disclosure obvious modifications and equivalents. It is intended that the scope of the present disclosure disclosed should not be limited by the disclosed embodiments described above but should be determined only by a fair reading of the claims that follow.