Patent ID: 12186226

The drawing figures are not necessarily drawn to scale, but instead are drawn to provide a better understanding of the components, and are not intended to be limiting in scope, but rather to provide exemplary illustrations. The figures illustrate exemplary configurations of a spinal orthosis having height and circumferential adjustment and the respective components, and in no way limit the structures or configurations of the spinal orthosis and components according to the present disclosure.

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS

A. Overview

A better understanding of different embodiments of the invention 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 and are described below in detail. It should be understood, however, there is no intention to limit the disclosure to the specific 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.

For further ease of understanding the embodiments of an orthopedic device in the exemplary form of a spinal orthosis and variants as disclosed, a description of a few terms is necessary. As used, the term “proximal” has its ordinary meaning and refers to a location situated next to or near the point of attachment or origin or a central point, or located toward the center of the body. Likewise, the term “distal” has its ordinary meaning and refers to a location situated away from the point of attachment or origin or a central point, or located away from the center of the body. The term “posterior” also has its ordinary meaning and refers to a location behind or to the rear of another location. Last, the term “anterior” has its ordinary meaning and refers to a location ahead of or to the front of another location.

The terms “rigid,” “flexible,” “compliant,” and “resilient” may be used to distinguish characteristics of portions of certain features of the orthopedic device. The term “rigid” should denote that an element of the device is generally devoid of flexibility. Within the context of features that are “rigid,” it is intended to indicate that they do not lose their overall shape when force is applied, and may break if bent with sufficient force. The term “flexible” should denote that features are capable of repeated bending such that the features may be bent into retained shapes or the features do not retain a general shape, but continuously deform when force is applied.

The term “compliant” may 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” may qualify such flexible features as generally returning to an initial general shape without permanent deformation. As for the term “semi-rigid,” this term may be used to connote properties of support members or shells that provide support and are free-standing; however such support members or shells may have some degree of flexibility or resiliency.

The embodiments of the disclosure are adapted for a human body, and may be dimensioned to accommodate different types, shapes and sizes of human body sizes and contours. For explanatory purposes, the orthosis embodiments described are referred to as corresponding to different sections of a body and are denoted by general anatomical terms for the human body.

The embodiments of the orthosis are particularly referred to as corresponding to anterior and posterior body sections by an anterior-posterior plane. The anatomical terms described are not intended to detract from the normal understanding of such terms as readily understood by one of ordinary skill in the art of orthopedics.

B. Various Embodiments of the Orthopedic Device and Components for Use Therewith

Under the embodiment inFIGS.1-5, an orthopedic device in the exemplary form of a spinal orthosis10is provided, among other functions, for increasing trunk muscle strength and improving posture in individuals with vertebral fractures.

The orthosis10includes a lumbar assembly12, a posterior frame assembly or spinal frame14, and a strap assembly16. The strap assembly16includes elongate straps18that engage an upper portion of the spinal frame14near or at the posterior shoulders and extend over the shoulders and under the armpits to orient a middle bracket assembly24on a middle portion of the spinal frame14. The straps18are redirected by brackets26carried by the middle bracket assembly24toward the anterior side of the lumbar assembly12whereat the strap ends20secure to the surface of the lumbar assembly12.

The strap assembly16permits downward pulling of the straps at a location, such as the waist or abdomen, which is easier for a geriatric individual to pull than at the shoulders, as in many prior art orthoses. Wearers of the orthosis that are arthritic or have poor dexterity need only pull down the straps at a location roughly below the chest to tighten the strap assembly over the shoulders. They may similarly attach the strap ends to the lumbar support at a relatively low location that is comfortable and easy for the wearer to manipulate.

Both the closure system of the lumbar assembly12and the spinal frame14may be covered by suitable sleeves or covers22,46to cushion and conceal these various features, leading to an aesthetically pleasing and comfortable arrangement. The lumbar assembly12includes first and second belt segments38A,38B (collectively38) which permit easy donning of the assembly over the waist. Suitable additional padding may be provided along the strap assembly, for example over the shoulders to provide compressive relief to the wearer when the strap assembly is tensioned, or along the spinal frame and lumbar assembly.

When assembling the spinal orthosis on a wearer, as shown inFIGS.1-3under the orthosis inFIGS.4A and4B, the wearer is preferably in a standing position and is encouraged to stand in an upright position. The wearer places the strap assemblies around shoulders similar to a backpack, whereas the strap ends are either freely extending from the middle bracket assembly downwardly toward or unattached to the lumbar support, or the strap ends are placed at temporary attachment points. The lumbar panel is centered on the spine with the bottom of the rigid posterior panel at approximately the sacrococcygeal joint. If the lumbar assembly includes a rigid or semi-rigid anterior panel, the anterior panel should be centered on the abdomen with the bottom edge just above the symphysis pubis while still allowing the individual to sit comfortably.

As shown inFIG.5A, the belt segments are then secured to one another overlapping one another and wrapping over the abdomen of the wearer. Once the belt segments are secured to the wearer, the wearer simultaneously pulls the handles30of the tensioning elements28toward the anterior center of the belt segments38A,38B and attaches the handles onto the surface of the belt segments when the appropriate tightness is obtained.

The wearer then removes handles of strap ends20of the strap assembly from temporary attachment points or hooks42on the left and right sides of the belt segments. The wearer is encouraged to lean into the posterior frame assembly as this makes it easier to tighten the strap assembly. The strap assembly is pulled so that the handles are attached to the belt segments, such as in an overlapping manner as shown inFIG.1, until a corrective and comfortable amount of compression is obtained in the strap assembly, or attached to attachment points or anterior hooks76,78on the belt segments at predetermined locations as shown inFIG.5BandFIG.23.

The bottom edge of the belt segments preferably sit below the hip. The end portion on the belt segment38B should be centered on the abdomen, and the handles30and the strap ends20are likewise placed on the end portion. It is preferable that the belt segments grip the waist, and have a higher level of tightness than the shoulder straps.

The tightening of the belt segments induces lordosis in the lower back, which improves the overall posture and reduces the load on the fractured vertebrae. The tightened belt arms also anchor the orthosis properly on the body. The strap assembly pulls the shoulders back without limiting mobility in the shoulder and arm area, and without impairing chest and abdominal breathing. With optimum adjustment, the wearer experiences pain alleviation and increased mobility.

When removing the brace, the strap ends20are removed from the hooks76,78, and attached to hooks on the sides of the belt segments38A,38B, as shown inFIG.5C. This allows for loosening of the strap system16. As for the lumbar assembly12, the handles30are adjusted to the sides of the belt segments proximate to the hooks76,78which loosens the tension in the lumbar assembly. The wearer can then freely remove the belt segments38A,38B and the strap assembly16, as shown inFIG.5D, since all are loosened to the point of brace removal.

Turning toFIGS.6and7, the posterior frame assembly includes the spinal frame14defining an elongate frame having a lower portion15corresponding to and extending from a lower portion of a lumbar panel or support32, such as a flexible or semi-rigid plate or frame, a middle portion17located above the lumbar support32and carrying the bracket assembly24, and an upper portion19carrying an upper bracket assembly34. The spinal frame14defines a plurality of openings21along its length, and is fixedly secured to the lumbar support32by a plurality of fasteners23. The spinal frame14may have a profile, as shown, in which the lower portion15flares outwardly and the spinal frame narrows in width as it approaches the upper portion19to anatomically conform to the wearer's anatomy.

The spinal frame14is preferably constructed from a malleable aluminum which can be shaped by a practitioner according to the individual anatomy of a wearer. The lumbar panel of the lumbar assembly may be formed from a plastic that is flexible relative to the spinal frame. Lateral side portions of the lumbar panel may flex relative to the spinal frame. While the spinal frame can be shaped according to an individual's anatomy, it is also provided to assure additional rigidity to ensure that the wearer's back can be pulled into extension. Alternatively, the spinal frame may be formed by injection molding a plastic covering over the metal strut.

A soft plastic or other suitable material may be attached to or formed on the lower end of the spinal frame to serve as a cushion element25for a wearer's sacrum. A method for forming a metallic frame within an overmolded plastic or various plastic layers is described more fully in U.S. Pat. No. 7,727,174, granted on Jun. 1, 2010, and incorporated by reference. Yet another alternative is hot forming the spinal frame under known materials and principles.

In observingFIGS.8-10, the orthosis10may include a cover that is dimensioned and configured to extend beyond the lumbar assembly12and the spinal frame14. The cover132is located adjacent the wearer, and generally follow the contours of the lumbar assembly12and spinal frame14. The lower and upper brace assemblies24,34may extend in part beyond the periphery of the cover132, and the handles30of the lumbar assembly12.

In this embodiment, the spinal frame14is located along the inside of the lumbar assembly12so the spinal frame is located between the lumbar assembly12and the wearer's back when the spinal orthosis is worn. The padding may comprise a strip only corresponding to the spinal frame and may not necessarily cover the entire spinal frame and the lumbar assembly. Alternatively, padding may be provided over the entire spinal frame and the lumbar assembly.

The middle bracket assembly24includes at least two brackets26extending from opposed side portions of the spinal frame14and pivoting about pivot points27. The bracket assembly24is located particularly above the lumbar support32, and the brackets26individually pivot at least above the lumbar support32in directions toward the upper and lower portions of the spinal frame. The upper bracket assembly34likewise has at least two brackets36that extend from opposed side portions of the spinal frame14at the upper portion, preferably the uppermost end of the upper portion, and similarly rotate about pivot points37. The pivoting nature of the bracket assemblies is such that they conform to the anatomy of the wearer and can be oriented at angles that facilitate tightening of the strap assemblies.

Each of the bracket assemblies includes the brackets26,36and extensions29,39secured to the spinal frame and carry the brackets26,36. The extensions may be flexible to conform to the anatomy of the wearer or alternatively they may be rigid or semi-rigid. The brackets are preferably D-rings sized accordingly to receive the straps.

The spinal frame14may come in predetermined sizes, or in the alternative may be selectively reducible in size. In one variation, the spinal frame14may include a plurality of key hole slots along its length, and the lumbar support includes a plurality of locking tabs which permit selective placement of the length of the spinal frame14relative to the lumbar frame, as particularly taught in U.S. patent application publication 2011/0105971, published on May 5, 2011, incorporated by reference.

In an example shown byFIG.11, another embodiment of the posterior frame assembly100includes a posterior frame102and a strap assembly104connected to the frame102. The strap assembly104adjustably secures to a pair of arms105depending from a generally U-shaped or alternatively shaped upper portion103of the frame102with padding114provided along the upper portion.

As shown inFIGS.12and13, the posterior frame102may be removably mounted onto a panel124, whether a rigid panel or a panel for use with the lumbar assembly described. The extension107of the posterior frame102defines a plurality of keyhole slots120that secure to pegs122extending from the panel124. To maintain the pegs122within the keyhole slots120, keyhole caps126may be placed within the keyhole slots120and wedge against the corresponding peg to prevent the extension107from becoming loose from the panel124.

Referring toFIG.11, the strap assembly104defines a pair of strap segments104A extending from the arms105to a slidable strap mount106located along an elongate extension107that may correspond to a posterior thoracic extension. The strap mount106defines a pair of brackets110on opposed sides of the extension107through which the strap segments104A extend. The strap mount106can adjustably slide along the extension107to an appropriate location to suit the needs of the wearer.

The strap mount106can be tensioned at strap ends112, or opened for removal from the extension at the strap ends112which removably secure to one another. An elongate strap pad108may cover at least part of the strap segment104A to provide additional padding to the chest and shoulder of the wearer when the strap segment104A is tensioned. The strap assembly104defines a strap segment104B which can be secured to the belt segments38, as similarly shown inFIG.1, by strap ends or tabs118.

FIGS.14and15depict adjustment of the strap assembly104with a strap segment104C extending from the arms105and securing onto the strap segment104A to adjust the length of the strap assembly at the upper portion103of the frame102. A strap tab128, preferably having an alligator clip with opposed sides of hook material arranged for clamping and securing onto loop material of the strap segment104C, is adjustably secured to the strap assembly104. At an initial fitting of the orthosis, the clinician can trim the length of the strap assembly and then secure the strap tab128onto the trimmed strap assembly. The strap tab128is secured by hook fasteners onto a surface of the strap segment104A.

A strap padding sleeve108slidably adjusts along the strap segment104A, and provides additional cushioning for the wearer when the strap assembly104is tensioned and urged against the shoulders and chest of the wearer. The padding sleeve108is adjusted to slide over the strap tab128to conceal the strap tab128, and minimize the strap tab128from catching on the clothing of the wearer.

FIGS.11and16depict the strap assembly104as including strap guides116having a loop117through which the strap segment104B passes through, and a base portion119for affixation onto side portions of the belt segments38. The strap segment104B slides through the loop117and the base portion119allows for adjustment of the strap segment104B according to the anatomy of the wearer and to assure proper location of securing the tabs118on the belt segment38.

As shown inFIGS.17and18, another embodiment of the strap assembly16may include a dosing system58. In the example shown, the strap assembly is tightened by pulling the strap18from near or at the shoulder, the dosing system58involves pulling the strap end62back through a bracket assembly63. Depending on the needed travel and the final placement of the strap end62, a clip or handle65is used for grasping to pull the strap18downward to affix it to the strap. If the strap end62ends in the armpit, one can remove the clip65and simply let the strap hang so it is not too difficult for the wearer to attach and deattach.

A plurality of indicia60, such as numbers, are displayed on the strap to represent relative tightening levels on the strap. A removable tab or stopper59with a window is then placed on the appropriate number by a clinician, where a number, such as 10 in the depicted example, indicates a dosing level, such as in maximum tension or a maximum tightening level of the strap18.

In an example, the strap end62is pulled by the wearer until the tab or stopper59prevents the strap from going any further. That way, it is ensured that the dosing is correct without the wearer having to look at the numbers. This may be advantageous for wearers with chronic pain of the back and having sensitivity to pressure on the impaired back.

In another strap assembly embodiment ofFIG.19, a buckle67is located along or adjacent the shoulder (whether on the anterior side, as shown, or on the posterior side of the shoulder) makes it easier for the wearer to adjust the strap rather than a D-ring. The buckle67makes it so the wearer need not hold the strap18while placing the strap end62down onto the strap. The strap end and the strap engage one another by known means, such as by hook and loop fasteners.

The strap assembly includes an intermediary strap64connecting to the spinal frame via one of the upper bracket assemblies discussed above. A tab66preferably has two flaps connected at one end, and have opposed faces with hook material so the flaps can enclose an end of the intermediary strap64by sandwiching a strap end of the intermediary strap64having hook receivable material to allow for a firm grasp of the strap. This arrangement is able to adjust the strap so the buckle67rests on top of the shoulders, slightly to the front, to assure the pull is easiest for the wearer since this reduces friction between the strap and buckle.

FIG.20illustrates a compression system40belonging to the lumbar assembly and having tensioning elements44(similar to tensioning element28) carrying handles30extending alongside each of the belt segments38A,38B inFIG.1. The compression system40has mounts48that slide relative to a lumbar panel32and individually secure to the belt segments via attachments50. The lumbar assembly may include anterior panels that are securable to an anterior portion of the belt segments. The lumbar assembly12may be a known assembly or one modified under U.S. patent application publication 2010/0217167, published on Aug. 26, 2010, and U.S. Pat. No. 8,172,779, granted on May 8, 2012, and incorporated by reference.

In reference toFIG.21, the handle30may comprise a soft structure constructed from at least three layers. The top layer52is a soft loop material so another handle can attach on top of this surface and hence the handle itself. A bottom layer56is constructed from a hook material having hook elements used to attach it to the belt segments. The center layer is a plastic layer54that attaches to the tensioning element or drawstring from the compression system.

The handle30defines an opening53through which a finger may be extended therethrough to simplify pulling of the tensioning element. The top layer52or other suitably soft material may extend about the periphery to provide a cushion about the opening. The strap ends of the strap assembly may likewise have a similar construction to the handle including the opening to facilitate pulling of the straps and affixation.

The bottom layer56may be configured so that only a portion57is secured against the plastic layer54. A portion61of the bottom layer56does not secure to the plastic layer54and corresponds to the opening53. When removing the handle from the belt segments, the wearer can slip a thumb through the opening53, and have better leverage by fully extending a thumb or finger through the opening53. The handle30is detached from the belt segments by peeling the hook elements of the bottom layer56downward and then outward for easy removal of the handle from the belt segments.

According to this embodiment, the handle is advantageous in that it is generally flexible and resilient so it can generally conform to the wearer's anatomy when secured over the belt segments but is also sufficiently durable to withstand forces exerted thereon when used to pull the tensioning elements. The handle is further advantageous in that it is sufficiently soft to enable easy use by geriatric or arthritic wearers.

FIG.22depicts an air bladder pad68that may be inserted into the cover46of the lumbar support to provide a dynamic padding element on the inside of the spinal orthosis, particularly against the spinal frame. The pad may be preinflated or adjustable so the wearer can inflate the pad to a given level, or alternatively the pad may be a foam or of similar construction that the wearer can selectively place between the cover and the spinal frame when necessary.

According toFIG.23, the spinal orthosis includes a consistent donning system that ensures that the wearer always places tension on the strap assembly in a consistent manner. The practitioner can set the strap assembly so that when placed on the wearer, it will exert the same tension. This has practical benefits in that the practitioner can regulate the tension in the strap assembly, and takes the guesswork away from the wearer to prevent over tightening of the strap assembly, and potential deleterious usage of the spinal orthosis.

The embodiment ofFIG.23employs a plurality of hooks or brackets70,76,78oriented to receive the strap ends20. The plurality of brackets may be placed at a plurality of sequential locations according to different tightening levels. Each of the brackets has a hook or pin72arranged to receive an opening74at the strap end20. The strap end may be arranged in a manner similar to the embodiment ofFIG.21regarding the handle, or may define a keyhole type configuration as depicted inFIG.24.

It follows from the consistent donning system that an attachment point is created in the front or anterior side of the belt segments so that when the straps are engaged in that location, the spinal orthosis is in tension. The additional brackets serve likewise as possible attachment points at different locations that may incur more or less tension. As shown inFIG.24, an attachment point may be provided that is used so the strap assembly is in a substantially loose configuration so the wearer can easily remove the spinal orthosis.

In reference to the embodiment ofFIGS.25and26, a magnetic locking system79is provided in which the strap end20includes a locking element84that mechanically and magnetically locks to one of a plurality of receptacles80,82on the belt segments38. The lock receptacles have a slot90and mount88that permit a pin86carried by the locking element to slide into the slot90and rest in the mount88. Fidlock GmbH of Hannover, Germany, provides an example of a magnetic locking system by the SNAP product.

The magnetic locking system is arranged in principle similar to the consistent donning system ofFIG.14in that the magnetic locking system in the system allows for consistent donning of the spinal orthosis, particularly affixation of the strap assembly.

In the embodiment ofFIGS.27-29, the spinal orthosis ofFIGS.1-3and the variations ofFIG.4Ais arranged for treatment of scoliosis. An elastic strap202has a first end secured to the spinal frame14and a second end adjustably securing to the lumbar assembly12.

A first variation of the elastic strap202has a first segment202A secured to the upper portion of the spinal frame14, and extends over the strap16so as to go over the shoulder onto the anterior side of the wearer. The strap16carries a pad19over which a second segment202B of the elastic strap may extend, and distributes any forces exerted by the elastic strap202. The pad19may include a guide222to orient the elastic strap202. The elastic strap202has a segment202C extending to the posterior side of the wearer and across the posterior side of the lumbar assembly12and/or spinal frame14. At least one guide218,220may be located along the lumbar assembly12and/or spinal frame14through which the elastic strap202may extend. A segment202D extends over an anterior side of the lumbar assembly12and adjustably secures thereto.

It follows that while a first strap segment of the strap assembly extends from the upper portion of the spinal frame and connects to a first middle bracket assembly located at the middle portion of the spinal orthosis, the elastic strap extends along the first strap segment generally to the first middle bracket assembly and further extends past the middle bracket assembly to secure to a second belt member belonging to the lumbar assembly, whereas a second strap segment extends from the first middle bracket assembly and secures to a first belt member belonging to the lumbar assembly.

The elastic strap202may include a bracket or tab204located at a first end that secures to the spinal frame. The tab204may carry a fastener206for securely and adjustably connecting to the spinal frame14. The spinal frame14may include a plurality of openings or brackets208arranged along its length by which the first end of the elastic strap202may removably secure. The openings or brackets208allow a clinician to selectively attach the elastic strap first end among a plurality of locations in order to adjust the strap to the specific needs of the wearer. The openings or brackets208may extend through or over the cover22of the spinal frame14.

The various brackets208may be constructed in a similar manner as the attachment points76,78, and the second end of the elastic strap may couple to the lumbar assembly to the same attachment points as the strap assembly. Alternatively, the elastic strap may include other fastener means, such as hook and loop type fastener elements, to secure over a plurality of locations of the lumbar assembly. For example, in order to trim the elastic strap to size, a strap tab bearing hook elements may couple to the second end of the elastic strap, and similarly bear an extension carrying hook elements that are engageable with a hook surface of the lumbar assembly.

The spinal orthosis may be defined as having first and second sides generally defined as opposed sides of a longitudinal axis of the spinal frame. The first end of the elastic strap202anchors to the first side of the spinal frame14, wraps around the first side of the wearer to extend across the posterior side of the wearer, and the second end of the elastic strap anchors to the anterior side of the lumbar assembly, preferably on the second side thereof. The elastic strap is oriented to encourage corrective movement of the spine and torso.

The spinal orthosis may include a plurality of elastic straps anchored at various locations along the spinal frame, and anchored to various locations along the lumbar assembly. Various elastic straps may be used having different tensions to encourage the desired resistance and corrective action, and may work together to stabilize or correct the spine. The straps of the strap assembly may be inelastic so that the elastic strap is elastically movable relative to the strap assembly.

In another embodiment of the elastic strap,FIGS.27-29show an elastic strap212securing to both the second side of the spinal frame14and connecting to a second side of the lumbar assembly12. The elastic strap212has a first end214that may similarly secures to the spinal frame14as the elastic strap202. In any of the embodiments, the elastic strap may be arranged on either the first or second sides of the spinal frame, at any number of heights along the spinal frame. Moreover, the elastic straps202and212may be used in combination with one another, with additional elastic straps, or in combination with inelastic straps including those in the strap assembly or in supplement to the strap assembly.

According to a method for using the spinal orthosis ofFIGS.27-29, the method employs the aforementioned spinal orthosis, and further includes the steps of securing a first end of an elastic strap to the spinal frame within the upper or middle portions and along a posterior side of a wearer, and securing a second end of the elastic strap to one of the first and second belt segments on the anterior side of the lumbar assembly. The method may include guiding the elastic strap through a strap guide connected to the spinal orthosis toward the one of the first and second belt segments.

It should be understood that not necessarily all objects or advantages may be achieved under any embodiment of the invention. For example, those skilled in the art will recognize that the invention may be embodied or carried out to achieve or optimizes one advantage or group of advantages as taught without achieving other objects or advantages as taught or suggested.

Those skilled in the art will recognize the interchangeability of various disclosed features. 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 spinal orthosis under principles of the present invention.

Although this invention has been disclosed in certain exemplary embodiments and variations, it therefore will be understood by those skilled in the art that the present invention extends beyond the disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents. It is intended that the scope of the present invention disclosed should not be limited by the disclosed embodiments described above.