Orthosis for prevention of joint dislocation

Abstract

A glenohumeral orthosis for preventing an anterior shoulder dislocation, the orthosis comprising a rigid shell substantially conformed to a shoulder of a user, the rigid shell being shaped and dimensioned to extend between an anterior portion overlapping a subcoracoid region of the user when the orthosis is worn, and a posterior portion at least partially overlapping a spine of scapula of the user when the orthosis is worn, and an interior-facing abutment disposed along the anterior portion of the rigid shell and positioned to overlie the user's subcoracoid region when the orthosis is worn to apply pressure thereto.

Description

ORTHOSIS FOR PREVENTION OF JOINT DISLOCATIONTECHNICAL FIELD

[0001] The technical field relates to an orthopedic device for joint stabilization. More particularly, the technical field relates to an orthopedic device for biomechanical stabilization of a joint.BACKGROUND

[0002] Anterior shoulder dislocation is the most common large-joint dislocation in young athletes. It typically results from traumatic forced abduction and external rotation of the shoulder, producing avulsion of the capsule and labrum from the glenoid rim as the humeral head dislocates.

[0003] A principal challenge following anterior shoulder dislocation is the high rate of recurrence which, although decreasing with age, may approach 90% in young, active patients. Current strategies to reduce recurrence range from sling immobilization to arthroscopic (key-hole) surgery for first-time dislocators. Each approach has drawbacks. Arthroscopic surgery entails substantial cost and recovery burden. Prolonged immobilization, on the other hand, can promote stiffness and functional impairment. Moreover, positioning the arm in internal rotation ( / .e., the conventional sling position) appears suboptimal for healing of lesions associated with anterior dislocation. Biomechanical and clinical investigations indicate that internal rotation may fail to approximate the detached capsule and labrum to the glenoid rim and magnetic resonance imaging has shown that, in internal rotation, the labrum can remain detached, leaving the glenoid rim exposed and predisposing to recurrent instability. At the same time, early and controlled motion is recognized as beneficial for tissue healing and for mitigating stiffness.

[0004] Accordingly, there remain a number of challenges with respect to glenohumeral stabilization orthosis, and in particular, glenohumeral stabilization orthosis enabling a desirable range of motion.SUMMARY

[0005] In accordance with an aspect, there is provided a glenohumeral orthosis for preventing an anterior shoulder dislocation, the orthosis comprising a rigid shell substantially conformed to a shoulder of a user, the rigid shell being shaped and dimensioned to extend between an anterior portion overlapping a subcoracoid region of the user when the orthosisis worn, and a posterior portion at least partially overlapping a spine of scapula of the user when the orthosis is worn, and an interior-facing abutment disposed along the anterior portion of the rigid shell and positioned to overlie the user’s subcoracoid region when the orthosis is worn to apply pressure thereto.

[0006] In certain embodiments, the interior-facing abutment is a pressure-applying protrusion formed on the inner surface of the rigid shell.

[0007] In certain embodiments, the interior-facing abutment includes a removable pad insert mounted to an inner surface of the rigid shell along the anterior portion at a pad attachment location.

[0008] In certain embodiments, the pad insert has a user specific custom shape that substantially conforms to the subcoracoid region of the user.

[0009] In certain embodiments, the pad insert is made of a rigid or semi-rigid material.

[0010] In certain embodiments, the pad insert is made of a compressible material configured to be in an uncompressed state when the glenohumeral orthosis is unworn, and a compressed state when the glenohumeral orthosis is worn by the user.

[0011] In certain embodiments, the rigid shell is configured to be removably secured about the shoulder of the user.

[0012] In certain embodiments, the rigid shell is a unitary rigid shell.

[0013] In certain embodiments, the rigid shell includes a contoured portion extending between the anterior and posterior portions.

[0014] In certain embodiments, the contoured portion is configured to overlap a supraclavicular area of the user when the orthosis is worn.

[0015] In certain embodiments, at the interior-facing abutment location, the anterior and posterior portions of the rigid shell are separated by a horizontal distance selected to cooperate with the interior-facing abutment to apply a compressive pressure to a subcoracoid region of the user when the orthosis is worn.

[0016] In certain embodiments, the orthosis further comprises a tensioning strap having a first end secured to the anterior portion of the rigid shell, and a second end secured to the posterior portion of the rigid shell.

[0017] In certain embodiments, the tensioning strap extends along an ipsilateral side of the torso when the orthosis is worn by the user.

[0018] In certain embodiments, the tensioning strap includes a user-operable tension adjustment mechanism configured to permit incremental tightening and loosening of the tensioning strap.

[0019] In certain embodiments, the tension adjustment mechanism is a dial-driven lace system comprising a rotatable dial operatively coupled to a spool that winds a tensile element to vary the effective length of the tensioning strap.

[0020] In certain embodiments, the tensioning strap is a first tensioning strap, the orthosis further comprising a second tensioning strap extending along a contralateral side of the torso when the orthosis is worn by the user.

[0021] In certain embodiments, the orthosis further comprises a third tensioning strap extending along the contralateral side of the torso when the orthosis is worn by the user.

[0022] In certain embodiments, at least one of the second and third tensioning straps is detachable.

[0023] In certain embodiments, at least one of the second and third tensioning straps includes a detachable buckle.

[0024] In certain embodiments, the orthosis further comprises an interior liner secured to the inner surface of the rigid shell.

[0025] In certain embodiments, the orthosis further comprises one or more underarm stabilizers configured to extend between the anterior portion and the posterior portion beneath the user’s armpit when the glenohumeral orthosis is worn.

[0026] In certain embodiments, the one or more underarm stabilizers are shaped and sized to inhibit upward displacement of the orthosis during use.

[0027] In certain embodiments, the rigid shell is substantially conformed to the shoulder of the user using a vacuum forming method.

[0028] In certain embodiments, the rigid shell includes at least one of plaster and fiberglass configured to be cast onto the shoulder of the user.

[0029] In certain embodiments, the rigid shell is a 3D printed shell substantially conformed to the shoulder of the user.

[0030] In certain embodiments, the rigid shell is made of at least one of thermoplastics, nylon and carbon fiber-infused filaments.

[0031] In certain embodiments, the rigid shell includes at least one of carbon fiber layers and fiberglass layers infused with a resin.

[0032] In certain embodiments, the resin is at least one of an epoxy resin and a polyester resin.

[0033] According to another aspect, there is provided a method of manufacturing a glenohumeral orthosis, comprising forming a rigid shell having an inner surface and an outer surface and including an anterior portion and a posterior portion, shaping the rigid shell such that, when worn by a user, the rigid shell is substantially conformed to the user’s shoulder with the anterior portion configured to overlie a subcoracoid region and the posterior portion configured to overlie at least a scapular spine while maintaining clearance about a glenohumeral joint, disposing an interior-facing abutment on the inner surface along the anterior portion and positioned to be aligned with the subcoracoid region when the orthosis is worn, the interior-facing abutment being configured to apply inward pressure to the subcoracoid region when the orthosis is worn, and setting a horizontal spacing between the anterior portion and the posterior portion to achieve a target pressure at the subcoracoid region when the orthosis is worn.

[0034] In certain embodiments, disposing the interior-facing abutment comprises integrally forming a pressure-applying protrusion on the inner surface of the anterior portion.

[0035] In certain embodiments, disposing the interior-facing abutment comprises securing a separately formed pad insert to the inner surface of the anterior portion.

[0036] In certain embodiments, forming the rigid shell comprises one or more of: vacuum forming a thermoplastic over a model of the user’s shoulder, casting a curable composite over the user, or additively manufacturing the shell from scan-derived anatomical data.

[0037] In certain embodiments, the method further comprises, after fitting the orthosis to the user, actuating a user-operable tension adjustment mechanism disposed along an ipsilateral side of the orthosis to vary a tension in a tensioning strap until a target inward pressure applied by the interior-facing abutment at the subcoracoid region of the user is achieved.

[0038] In certain embodiments, actuating the tension adjustment mechanism comprises rotating a dial to wind or unwind a tensile element of a dial-driven lace system to increase or decrease the pressure applied by the interior-facing abutment.

[0039] In certain embodiments, the tension adjustment mechanism is operable while the orthosis is worn to adjust the pressure without removing the orthosis.BRIEF DESCRIPTION OF THE DRAWINGS

[0040] The attached figures illustrate various features, aspects and implementations of the technology described herein.

[0041] FIG. 1 is a front perspective view of a glenohumeral orthosis, in accordance with an embodiment, shown worn by a user.

[0042] FIG. 2 is a rear elevation view of the glenohumeral orthosis of FIG. 1, shown worn by a user.

[0043] FIG. 3 is right-side elevation view of the glenohumeral orthosis of FIG. 1.

[0044] FIG. 4 is bottom plan view of the glenohumeral orthosis of FIG. 1.

[0045] FIG. 5 is a right-side elevational view of the glenohumeral stabilization orthosis of FIG. 1, illustrating a pad insert.

[0046] FIG. 6 is a right-side elevational view of the glenohumeral stabilization orthosis of FIG. 5, showing the pad insert in a removed position.DETAILED DESCRIPTION

[0047] Techniques described herein relate to systems, devices and methods for preventing a joint dislocation including, for instance, an anterior shoulder dislocation. More specifically, the techniques described herein relate to systems, devices and methods for limiting a displacement of a humeral head beyond the glenoid fossa and toward a frontwards portion of the body.

[0048] During an anterior dislocation, the humeral head ( / .e., the ball of the shoulder joint) can be forced out of the glenoid fossa and move forward, typically toward or beneath the coracoid process. The area beneath the coracoid process is typically referred to as the subcoracoid region. This type of dislocation typically occurs when the arm is in an abducted,externally rotated, and extended position, such as when reaching or lifting an object such as, for instance, during sport activities. In certain instances, the dislocated humeral head may move anteriorly and sometimes inferiorly, leading to a subcoracoid dislocation, where the humeral head is palpable beneath or in front of the coracoid process. Accordingly, the coracoid process serves as a key anatomical landmark in identifying this type of dislocation.

[0049] In certain instances, the force of the dislocation can result in damage to the glenoid labrum, particularly in the form of a Bankart lesion, a tear of the labrum at the anterior part of the shoulder, which can extend near the coracoid process. Ligaments around the shoulder, including the coracohumeral ligament, can also be stretched or torn, contributing to the instability of the joint. The muscles attached to the coracoid process, such as the pectoralis minor, coracobrachialis, and the short head of the biceps brachii, may also be affected by the dislocation, leading to pain and reduced shoulder function. While rare, the coracoid process itself can be fractured during a severe shoulder dislocation, further complicating the injury and affecting shoulder stability.

[0050] In certain embodiments, it can thus be desirable to limit or prevent an anterior dislocation of the humeral head by providing a glenohumeral orthosis configured to provide pressure at or near the subcoracoid region. For instance, in certain embodiments, the glenohumeral orthosis can include a rigid shell substantially conformed to a shoulder of a user, the rigid shell extending between an anterior portion overlapping a subcoracoid region of the user when the glenohumeral orthosis is worn, and a posterior portion overlapping a spine of scapula of the user when the glenohumeral orthosis is worn. In certain embodiments, the glenohumeral orthosis can further include a pad insert configured to be mounted to an inner surface of the rigid shell along the anterior portion at a pad attachment location, the pad insert having a user specific custom shape that substantially conforms to the subcoracoid region of the user.

[0051] In some embodiments, it can further be desirable to provide a glenohumeral orthosis sized to be concealed underneath a user’s clothing or sporting equipment. The concealment of the glenohumeral orthosis may reduce interference with the user’s regular activities and encourage a more consistent wearing of the glenohumeral orthosis.

[0052] It will be appreciated that positional descriptions such as “above”, “below”, “left”, “right”, “inwardly”, “outwardly” and the like should, unless otherwise indicated, be taken in the context of the figures, and should not be considered limiting. The term “outwardly” is intended to refer to a feature that extends toward an exterior side of a reference axis. Theterm “inwardly” is intended to refer to a feature that extends toward an interior side of a reference axis. It should also be understood that elongated objects described herein are considered to have an implicit "longitudinal axis" and “lateral axis”. The expression “longitudinal axis” is intended to refer to an axis extending along the length of the object, and the expression “lateral axis” is intended to refer to an axis extending perpendicularly to the longitudinal axis, along the width of the object. When referring to a longitudinal direction, it is intended to refer to a direction that extends substantially parallel to the longitudinal axis of the object, encompassing as well as directions that deviate slightly from the longitudinal axis. When referring to a lateral direction, it is intended to refer to a direction that extends substantially parallel to the lateral axis of the object, encompassing as well as directions that deviate slightly from the lateral axis.

[0053] Various implementations and features of the glenohumeral stabilization orthosis will now be described in greater detail in the following paragraphs.General description of the glenohumeral orthosis

[0054] Referring to FIGS. 1 to 4, there is provided a glenohumeral orthosis 100 configured to apply a pressure to a subcoracoid region of a user 10 so as to prevent or minimize the risk of a dislocation of the shoulder. Broadly, the glenohumeral orthosis 100 includes a rigid shell 110 substantially conformed to a shoulder of the user 10 at risk of dislocation and configured to be removably secured thereto. In particular, the rigid shell 110 can be shaped so as to apply a pressure to the subcoracoid region of the user 10 suitable to prevent or minimize the risk of glenohumeral dislocation. In the illustrated embodiment, the rigid shell 110 of the glenohumeral orthosis 100 extends between an anterior portion 112 overlapping the subcoracoid region of the user 10, and a posterior portion 114 overlapping a back portion of the user 10 when the glenohumeral orthosis 100 is worn including, for instance, a shoulder blade of the user. More specifically, in certain embodiments, the posterior portion 114 of the rigid shell 110 can overlap at least the spine of scapula of the user opposite the subcoracoid region when the glenohumeral orthosis 100 is worn by the user 10.

[0055] In the non-limitative embodiment shown, the rigid shell 110 of the glenohumeral orthosis 100 further includes a contoured portion 116 extending between the anterior and posterior portions 112, 114. In certain embodiments, the contoured portion 116 can overlap the supraclavicular area of the user 10 and extend between the subcoracoid region of the user 10 and the back portion of the user 10, as shown in FIGS. 1 to 4. In other embodiments, the contoured portion 116 can extend along the lateral thoracic region of theuser 10 between the subcoracoid region of the user 10 and the back portion of the user 10. In this manner, when the contoured portion 116 is present, the rigid shell 110 of the glenohumeral orthosis 100 is a unitary shell ( / .e. forming a single body). In certain embodiments, the unitary construction of the rigid shell 110 may improve the functionality of the glenohumeral orthosis 100, as described in greater detail below.

[0056] As used herein, “substantially conformed" to a shoulder means that the rigid shell 110 is shaped to generally follow the three-dimensional contours of the user’s shoulder complex so that, when worn, the inner surface 111 of the rigid shell 110 closely approximates the anterior subcoracoid / deltopectoral region, the clavicular and acromial regions, and at least the spine of the scapula posteriorly, while maintaining intended clearances around the glenohumeral joint to preserve the desired range of motion. It will be understood that a perfect anatomical replication is not required and that manufacturing tolerances, user-to-user anatomical variation, and compliance of an interior liner are contemplated. In certain embodiments, a substantial conformity may be achieved by custom forming or casting the rigid shell 110 on the user 10, by scan-based fabrication (e.g., 3D printing), or by size-graded shells fitted and tuned with adjustable padding, provided the rigid shell 110 retains its intended geometry and functional relationships under expected loads during use.

[0057] Referring specifically to FIG. 3, in certain embodiments, the rigid shell 110 of the glenohumeral orthosis 100 may further define a lateral opening 118 sized to enable a passage of an arm 12 of the user 10 when the glenohumeral orthosis 100 is worn. More specifically, in certain embodiments, the rigid shell 100 may extend up to the glenohumeral joint without extending over the deltoid of the user 10. In this manner, it will be appreciated that the glenohumeral orthosis 100 described herein may prevent or limit the risk of a shoulder dislocation without limiting or preventing glenohumeral external rotation during at least one of shoulder abduction, extension and anterior flexion. More specifically, the glenohumeral orthosis 100 can enable an unencumbered range of motion of the glenohumeral joint.

[0058] As described above, the glenohumeral orthosis 100 can be configured to apply pressure to the subcoracoid region. In some embodiments, the anterior portion 112 of the rigid shell 110 includes an interior-facing abutment 113 aligned with the user’s subcoracoid region when the glenohumeral orthosis 100 is worn to apply a desired target pressure. The abutment 113 may be defined by a pressure-applying protrusion formed on the inner surface 111 of the rigid shell 110 and positioned to overlie the subcoracoid region in use. In certainembodiments, the interior-facing abutment 113 can include a removable pad insert 120 carried on or integrated with the pressure-applying protrusion to tailor contact geometry and pressure distribution, as described in greater detail below. In other embodiments, the pad insert 120 can replace the pressure-applying protrusion and itself define the interior-facing abutment 113 when affixed to the inner surface 111 of the rigid shell. In this manner, a horizontal distance between the anterior and posterior portions 112, 114 of the rigid shell 110 can be selected to cooperate with the interior-facing abutment 113 to provide the target pressure to the subcoracoid region when the glenohumeral orthosis 100 is worn, enabling custom-fitting to the user 10.

[0059] As used herein, the expression “target pressure" refers to a selected interface pressure imparted by the interior-facing abutment 113 to soft tissues anterior to and beneath the coracoid process, sufficient to counter anterior translation of the humeral head during permitted ranges of motion while avoiding undue discomfort, sensory changes, or vascular compromise.

[0060] It will be understood that, as used herein, the expression “aligned with the subcoracoid region" is intended to signify that, when the glenohumeral orthosis 100 is properly worn, the interior-facing abutment 113 is positioned and oriented so that it overlies and faces the user’s subcoracoid region ( / .e., the soft tissues anterior to and beneath the coracoid process), such that inwardly directed force from the abutment is transmitted into that region to resist anterior translation of the humeral head. The alignment encompasses both location ( / .e., centering of the abutment within the subcoracoid region) and orientation ( / .e., the abutment surface directed inward toward the subcoracoid region), and includes normal positional tolerances that still deliver the intended pressure across the shoulder postures permitted by the glenohumeral orthosis 100. It will be understood that the alignment does not require direct contact with the coracoid process and may be achieved or refined by the pad insert 120 of the glenohumeral orthosis 100, as described in greater detail below.

[0061] It will be further understood that, as used herein, the expression “rigid' is intended to refer to a construction of the shell 110 being substantially resistant to bending or adjustment of its shape. For instance, in some embodiments, the horizontal distance between the anterior and posterior portions 112, 114 of the rigid shell 110 can vary less than approximately 10% when the glenohumeral orthosis 100 is worn by the user 10. In other embodiments, the horizontal distance between the anterior and posterior portions 112, 114 of the rigid shell 110 can vary less than approximately 5% when the glenohumeral orthosis 100 is worn by the user 10. In other embodiments still, the horizontal distance between theanterior and posterior portions 112, 114 of the rigid shell 110 can vary less than approximately 2% when the glenohumeral orthosis 100 is worn by the user 10.

[0062] Referring to FIG. 4, in certain embodiments, at least a portion of the rigid shell 110 can be enveloped within a woven or non-woven fabric to improve a comfort to the user 10 and / or prevent injuries caused by an impact between the rigid shell 110 and the user 10, for instance, during physical activity. For instance, the glenohumeral orthosis can include an interior liner 119 secured to the inner surface 111 of the rigid shell 110. In certain embodiments, the interior liner 119 may be formed of a soft, impact-absorbing material configured to distribute localized loads from the rigid shell 110 and to improve wearer comfort. Suitable materials for the interior liner 119 may include, without limitation, neoprene, open-cell or closed-cell polyurethane foams, ethylene-vinyl acetate (EVA) foams, polyethylene foams, thermoplastic elastomer foams, viscoelastic foams, silicone gel or hydrogel layers, spacer mesh fabrics, woven or non-woven textiles, felts, and combinations or laminates thereof. The interior liner 119 may be continuous or sectional, may be bonded, sewn, or removably affixed to the inner surface 111 of the rigid shell 110 (e.g., with adhesive, hook-and-loop, or mechanical fasteners), and may optionally include moisture-wicking, breathable, or antimicrobial facings.

[0063] As stated above and referring now to FIGS. 5 and 6, in certain embodiments the interior-facing abutment 113 may include a pad insert 120 disposed at a pad attachment location 117 on the inner surface 111 along the anterior portion 112, in alignment with the subcoracoid region when the glenohumeral orthosis 100 is worn. The pad insert 120 may define the user-contacting surface of the abutment 113 and can be sized and shaped — optionally as a user-specific custom form — to substantially conform to the subcoracoid region and enhance comfort while delivering the intended pressure. The pad insert 120 can be made of any suitable compressible or semi-compressible material, including a woven or non-woven fabric, polyurethane foam, ethylene-vinyl acetate (EVA), polyethylene foam, silicone gel, hydrogel, or combinations thereof. In various examples, the pad insert 120 is bonded, overmolded, captured within a recess, or removably coupled (e.g., with hook-and-loop) to the convex bump of the abutment 113 to permit adjustment or replacement while maintaining an integrated abutment construction. In some embodiments, the abutment 113 may be formed substantially or entirely by the pad insert 120 affixed to the inner surface 111.

[0064] As stated above and referring now to FIGS. 5 and 6, in certain embodiments the interior-facing abutment 113 may include a pad insert 120 configured to be mounted to theinner surface 111 of the rigid shell 110. More specifically, the pad insert 120 can be secured to the rigid shell 110 along the anterior portion 112 of the rigid shell 110 at a pad attachment location 117 in alignment with the subcoracoid region when the glenohumeral orthosis 100 is worn. In certain embodiments, the pad insert 120 can be sized to apply the desired pressure to the subcoracoid region of the user 100 when the glenohumeral orthosis 100 is worn. More specifically, in certain embodiments, the pad insert 120 can have a user specific custom shape that substantially conforms to the subcoracoid region of the user 10 to enhance comfort for the wearer. The pad insert 120 can be made of any suitable compressible material including a woven or non-woven fabric, polyurethane foam, ethylene-vinyl acetate, polyethylene foam, silicone gel, hydrogel, or the like.

[0065] In certain embodiments, the pad insert 120 may be made of a rigid or semi-rigid material suitable for applying the desired pressure to the subcoracoid region. Examples of semi-rigid materials suitable for the construction of the pad insert 120 include polyurethane foam, polyethylene, polyvinyl chloride, rubber, or the like. In other embodiments, the pad insert 120 may be made of a compressible material with the pad insert 120 being in a uncompressed state when the glenohumeral orthosis 100 is unworn, and a compressed state when the glenohumeral orthosis 100 is worn by the user 10, so long as the pad insert 120 is able to apply the desired pressure to the subcoracoid region when in the compressed state.

[0066] In certain embodiments, when the interior liner 119 is present, the pad insert 120 can be mounted between the interior liner 119 and the rigid shell 110 to retain the pad insert 120 in the alignment with the subcoracoid region when the glenohumeral orthosis 100 is worn, as shown in FIGS. 5 and 6.

[0067] In certain embodiments, the glenohumeral orthosis 100 can further include one or more tensioning straps 130 configured to secure the rigid shell 110 to the torso 12 of the user 10 and / or to adjust the pressure applied to the subcoracoid region of the user 10. In the non-limitative embodiment shown, the glenohumeral orthosis 100 includes a first tensioning strap 132 having opposite first and second ends 132a, 132b secured to the anterior and posterior portions 112, 114 of the rigid shell 110, respectively. In the illustrated embodiment, the first tensioning strap 132 extends between the anterior and posterior portions 112, 114 of the rigid shell 110 along an ipsilateral side of the user’s torso 12 when the glenohumeral orthosis 100 is worn.

[0068] In the non-limitative embodiment shown, the glenohumeral orthosis 100 further includes second and third tensioning straps 134, 136, each of the second and third tensioning straps 134, 136 similarly having opposite first ends 134a, 136a and second ends 134b, 136b secured to the anterior and posterior portions 112, 114 of the rigid shell 110, respectively. In certain embodiments, each of the second and third tensioning straps 134, 136 can extend between the anterior and posterior portions 112, 114 of the rigid shell 110 along a contralateral side of the user’s torso 12 ( / .e., in a direction opposite to that of the first tensioning strap 132), including beneath the contralateral armpit or around the contralateral supraclavicular area.

[0069] In certain embodiments, one or more of the tensioning straps 130 of the glenohumeral orthosis may be detachable ( / .e., a portion of a given one of the tensioning straps 130 may be separated from a remaining portion of the given one of the tensioning straps 130) to facilitate an installation of the glenohumeral orthosis 110 on the user 10. For instance, in the illustrated embodiment, each of the second and third tensioning strap 134, 136 is a detachable tensioning strap 130. More specifically, each of the second and third tensioning straps 134, 136 includes a detachable buckle 137 provided proximate the first end 134, of the respective second and third tensioning strap to enable a detachment of the first and second tensioning straps 134, 136.

[0070] In certain embodiments, one or more of the tensioning straps 130 may include a user-operable tension adjustment mechanism 138 configured to permit incremental tightening and loosening of the respective tensioning strap 130 without removing the glenohumeral orthosis 100. In some examples and as shown in FIG. 3, the tension adjustment mechanism 138 may be a dial-driven lace system (e.g., a BOA-type system) including a rotatable dial operatively coupled to a spool that winds a tensile element (such as a cable or lace) to vary the effective length of the respective tensioning strap 130, optionally with a quick-release feature. In certain embodiments, the tension adjustment mechanism 138 may be mounted on the anterior portion 112, the posterior portion 114, or along the respective tensioning strap 130 itself, and may employ low-profile components suitable for concealed wear. In the illustrated embodiment, the first tensioning strap 132 includes such a tension adjustment mechanism 138 to enable fine control of the pressure applied to the subcoracoid region during use. It will be understood that, in other embodiment, the glenohumeral orthosis 100 may include one or more equivalent micro-adjust systems (e.g., ratchet, cam, ladder-lock, or buckle-based systems) in addition to or in place of the tension adjustment mechanism 138.

[0071] In certain embodiments, the glenohumeral orthosis 100 may further include one or more underarm stabilizers 140 configured to extend between the anterior portion 112 and the posterior portion 114 beneath the user’s armpit when the glenohumeral orthosis 100 is worn. Still referring to FIG. 3, the underarm stabilizers 140 may be arranged to inhibit upward (cephalad) displacement or “ride-up” of the glenohumeral orthosis 100 during use. Each underarm stabilizer 140 may be semi-rigid so as to provide positional control while remaining sufficiently compliant to facilitate donning and doffing of the glenohumeral orthosis 100. In the illustrated embodiment, two underarm stabilizers 140 are provided. More specifically, the glenohumeral orthosis 100 shown in FIG. 3 includes an anterior underarm stabilizer 142 extending rearward from the anterior portion 112 toward the posterior portion 114, and a posterior underarm stabilizer 144 extending forward from the posterior portion 114 toward the anterior portion 112. The underarm stabilizers 140 may be attached to the rigid shell 110 (e.g., integrally formed, bonded, or mechanically fastened) or may be incorporated into or supported by the interior liner 119 described herein. In certain embodiments, the underarm stabilizers 140 may further include contoured edges, local padding, and / or ventilation features, and may cooperate with the tensioning straps 130 to distribute loads and maintain vertical positioning.

[0072] It will further be understood that, in other embodiments, the glenohumeral orthosis 100 may include any other suitable number of tensioning straps 130 configured to extend along any other suitable portion of the user’s body to securely attach the glenohumeral orthosis 100. It will further be appreciated that the above specified positioning of the tensioning straps 130 around the user’s torso 12 may enable the glenohumeral orthosis 100 to be worn underneath regular garments to thus enable the glenohumeral orthosis 100 to remain at least partially concealed when worn. Additional features that may facilitate concealment of the glenohumeral orthosis 100 may include a slim, contoured profile of the rigid shell 110 with tapered edges and geometry that conforms closely to the user’s shoulder, low-profile componentry positioned in recessed pockets or flush mounts on the anterior portion 112 and / or posterior portion 114, routing of the tensioning straps 130 along the torso 12 that avoids bulk over the acromial / deltoid region, underarm stabilizers 140 and tensioning strap 130 pathways arranged to minimize protrusions at the axilla, smooth exterior surfaces with integrated strap channels to reduce printing through garments, compliant margin zones and / or flexible overmolds at edges of the rigid shell 110 to improve drape, and thin, breathable, compressible interior liner 119 constructions that distribute loads without adding visible thickness. In certain embodiments, the glenohumeral orthosis 130 may terminate short of the deltoid muscle and may maintain clearance around theglenohumeral joint to preserve a fit of a user’s sleeve, and may employ muted or garment-matching finishes. Collectively, it will be understood that these characteristics may enable the glenohumeral orthosis 100 to remain substantially concealed while maintaining the intended pressure at the subcoracoid region.

[0073] As discussed above, the glenohumeral orthosis 100 is configured to apply a target pressure at the subcoracoid region when worn. As can now be appreciated, the target pressure may be established and maintained by one or more of: selecting the horizontal spacing between the anterior and posterior portions 112, 114 of the rigid shell 110, actuating a tension adjustment mechanism 138 to vary a tension in one or more of the tensioning straps 130, selecting a geometry of the interior-facing abutment 113, and a compliance of the interior liner 119 and / or the pad insert 120 to distribute load. In various embodiments, the target pressure is specified as a range that may be user-specific and activity-dependent, and may be verified during fitting by physical examination, user feedback, and / or optional pressure-sensing elements. The rigidity of the rigid shell 110 and the compliance of the interior liner 119 may cooperate to maintain the target pressure within acceptable tolerances across expected postures.

[0074] The rigid shell of the glenohumeral orthosis 100 can be manufactured using any known means suitable for the formation of a custom-fitted orthosis. For instance, in certain embodiments, the rigid shell 110 can be substantially conformed to the shoulder of the user 10 using a vacuum forming method. In other embodiments, the rigid shell 110 can include at least one of plaster and fiberglass configured to be cast onto the shoulder of the user 10, the rigid shell can be a 3D printed shell substantially conformed to the shoulder of the user 10, the rigid shell 110 can be made of at least one of thermoplastics, nylon and carbon fiber-infused filament, the rigid shell 110 can include at least one of carbon fiber layers and fiberglass layers infused with a resin with the resin being at least one of an epoxy resin and a polyester resin and / or the like.

[0075] In certain embodiments (not shown), the glenohumeral orthosis 100 may include a pair of rigid shells 110 configured for use on opposite shoulders of the user 10, each rigid shell 110 including an anterior portion 112 and a posterior portion 114 as described above. The two rigid shells 110 may be operatively interconnected by the tensioning straps 130 routed across the user’s torso 12 such that tension developed in the tensioning straps 130 cooperates with each rigid shell 110 to maintain their positioning and to apply a target pressure at the respective subcoracoid regions. In certain embodiments, each of the rigid shells 110 may include a lateral tensioning strap 132 which can extend between theirrespective anterior and posterior portions 112, 114, and second and third tensioning straps 134, 136 routed contralaterally between the anterior and posterior portions 112, 114, respectively, to complete the interconnection. Each rigid shell 110 may include its own interior-facing abutment 113 (optionally including a pad insert 120 at a pad attachment location 117) aligned with the corresponding subcoracoid region, and may further include a lateral opening 118 and an interior liner 119, as described above. One or more tension adjustment mechanisms 138 may be provided on one or both sides to permit independent or coupled adjustment of strap tension, and detachable buckles 137 may facilitate donning and doffing. In various implementations, underarm stabilizers 140 may be provided beneath each axilla to inhibit upward displacement. It will be understood that a dual-shell configuration of the glenohumeral orthosis 100 can provide bilateral stabilization or, when used primarily for unilateral instability, can utilize the contralateral rigid shell 110 as an anchor to enhance retention while preserving concealability.

[0076] While the description of the glenohumeral orthosis 100 provided above relates to the prevention of a glenohumeral dislocation, it will be appreciated that, in other embodiments, the present glenohumeral orthosis 100 can be similarly configured to prevent a dislocation of any other joint susceptible to dislocation including, for instance, the patellofemoral joint, the interphalangeal joint, the elbow, the hip, the temporomandibular joint, the ankle or the wrist by providing pressure to a region of the body susceptible to receive the joint during a dislocation.

[0077] Methods of manufacture for the glenohumeral orthosis 100 will now be described. In certain embodiments, the manufacturing includes forming a rigid shell 110 having an inner surface 111 and an outer surface, the rigid shell 110 including an anterior portion 112 and a posterior portion 114. The rigid shell 110 is shaped such that, when worn by a user 10, the shell is substantially conformed to the user’s shoulder, with the anterior portion 112 configured to overlie a subcoracoid region and the posterior portion 114 configured to overlie at least a scapular spine, while maintaining a clearance about the glenohumeral joint sufficient to preserve the desired range of motion as described herein.

[0078] In certain embodiments, the method may further include disposing an interior-facing abutment 113 on the inner surface 111 along the anterior portion 112 and positioned to be aligned with the subcoracoid region when the glenohumeral orthosis 100 is worn, the interior-facing abutment 113 being configured to apply inward pressure to the subcoracoid region during use. In some embodiments, disposing the interior-facing abutment 113 includes integrally forming a pressure-applying protrusion on the inner surface 111 of theanterior portion 112 (e.g., by molding, thermoforming, or overmolding) so that the pressureapplying protrusion presents a contact surface directed toward the subcoracoid region in use.

[0079] In other embodiments, disposing the interior-facing abutment 113 includes securing a separately formed pad insert 120 to the inner surface 111 along the anterior portion 112 at a pad attachment location 117. The pad insert 120 may define, or cooperate to define, the interior-facing abutment 113 and can be sized and shaped to substantially conform to the subcoracoid region and to tailor contact geometry and pressure distribution. The pad insert 120 may be bonded, mechanically fastened, captured in a recess, or otherwise affixed to the inner surface 111, and may be formed of compressible or semi-compressible materials as described above. In certain embodiments, the pad insert 120 is used in addition to, or in place of, a pressure-applying protrusion.

[0080] Forming the rigid shell 110 may be accomplished by any suitable technique. In various embodiments, forming includes one or more of: vacuum forming a thermoplastic over a model of the user’s shoulder (e.g., a positive mold derived from a scan or cast), casting or laminating a curable composite over the user 10 or over a corresponding anatomical model, or additively manufacturing the shell 110 from scan-derived anatomical data, followed by optional post-processing such as edge finishing, creation of local reliefs, or surface texturing. Optional features such as a contoured portion 116 and / or provisions for an interior liner 119 may be formed or prepared during these operations.

[0081] The method may further include setting a horizontal spacing between the anterior portion 112 and the posterior portion 114 to achieve a target pressure at the subcoracoid region when the glenohumeral orthosis 100 is worn. In practice, this may include selecting the shell geometry (including the relative positions of the anterior portion 112 and posterior portion 114), material thickness and rigidity, and, where applicable, the height and footprint of the interior-facing abutment 113 and the compliance of the interior liner 119 and / or pad insert 120, such that the inward force transmitted through the interior-facing abutment 113 produces the target interface pressure at the subcoracoid region across expected wearing postures.

[0082] After fitting the glenohumeral orthosis 100 to the user 10, the method may further include actuating a user-operable tension adjustment mechanism 138 disposed along an ipsilateral side of the glenohumeral orthosis 100 to vary a tension in at least one of the tensioning straps 130 (e.g., a first tensioning strap 132) until a target inward pressureapplied by the interior-facing abutment 113 at the user’s subcoracoid region is achieved. In some embodiments, actuating the tension adjustment mechanism 138 includes rotating a dial to wind or unwind a tensile element of a dial-driven lace system to increase or decrease the pressure applied by the interior-facing abutment 113. The tension adjustment mechanism 138 may be operable while the glenohumeral orthosis 100 is worn to adjust pressure without removing the glenohumeral orthosis 100, and may optionally include a quick-release.

[0083] It will be appreciated that the foregoing manufacturing steps can be performed in any suitable order and may include additional sub-steps such as verifying alignment of the interior-facing abutment 113 with the subcoracoid region during trial fitting, calibrating the tension adjustment mechanism 138 to a user-specific target pressure range, and finishing operations (e.g., integrating the interior liner 119, trimming edges, installing low-profile hardware, or incorporating an underarm stabilizer 140) that maintain the intended geometry, comfort, and concealability of the glenohumeral orthosis 100 when worn on the torso 12 with the arm 14 in expected postures.

[0084] To provide a more concise description, some of the quantitative expressions provided herein are qualified with the term "about". It will be understood that whether the term "about" is used explicitly or not, every quantity recited herein is meant to refer to an actual given value, and it is also meant to refer to the approximation to such given value that would reasonably be inferred by a person of ordinary skill in the art, including approximations due to the experimental and / or measurement conditions for such given value.

[0085] Several alternative embodiments and examples have been described and illustrated herein. The embodiments of the invention described above are intended to be exemplary only. A person of ordinary skill in the art would appreciate the features of the individual embodiments, and the possible combinations and variations of the components. A person of ordinary skill in the art would further appreciate that any of the embodiments could be provided in any combination with the other embodiments disclosed herein. It is understood that the invention may be embodied in other specific forms without departing from the central characteristics thereof. The present examples and embodiments, therefore, are to be considered in all respects as illustrative and not restrictive, and the invention is not to be limited to the details given herein. Accordingly, while the specific embodiments have been illustrated and described, numerous modifications come to mind. The scope of the invention is therefore intended to be limited solely by the scope of the appended claims.

Claims

CLAIMS1. A glenohumeral orthosis for preventing an anterior shoulder dislocation, the orthosis comprising:a rigid shell substantially conformed to a shoulder of a user, the rigid shell being shaped and dimensioned to extend between an anterior portion overlapping a subcoracoid region of the user when the orthosis is worn, and a posterior portion at least partially overlapping a back portion of the user when the orthosis is worn; andan interior-facing abutment disposed along the anterior portion of the rigid shell and positioned to overlie the user’s subcoracoid region when the orthosis is worn to apply pressure thereto.

2. The orthosis of claim 1, wherein the interior-facing abutment is a pressureapplying protrusion formed on an inner surface of the rigid shell.

3. The orthosis of claim 1, wherein the interior-facing abutment includes a removable pad insert mounted to an inner surface of the rigid shell along the anterior portion at a pad attachment location.

4. The orthosis of claim 3, wherein the pad insert has a user specific custom shape that substantially conforms to the subcoracoid region of the user.

5. The orthosis of claim 3 or 4, wherein the pad insert is made of a rigid or semirigid material.

6. The orthosis of claim 3 or 4, wherein the pad insert is made of a compressible material configured to be in an uncompressed state when the glenohumeral orthosis is unworn, and a compressed state when the glenohumeral orthosis is worn by the user.

7. The orthosis of any one of claims 1 to 6, wherein the rigid shell is configured to be removably secured about the shoulder of the user.

8. The orthosis of any one of claims 1 to 7, wherein the rigid shell is a unitary rigid shell.

9. The orthosis of any one of claims 1 to 8, wherein the rigid shell includes a contoured portion extending between the anterior and posterior portions.

10. The orthosis of claim 9, wherein the contoured portion is configured to overlap a supraclavicular area of the user when the orthosis is worn.

11. The orthosis of any one of claims 1 to 10, wherein, at a location of the interior-facing abutment, the anterior and posterior portions of the rigid shell are separated by a horizontal distance selected to cooperate with the interior-facing abutment to apply a compressive pressure to a subcoracoid region of the user when the orthosis is worn.

12. The orthosis of any one of claims 1 to 11 , further comprising a tensioning strap having a first end secured to the anterior portion of the rigid shell, and a second end secured to the posterior portion of the rigid shell.

13. The orthosis of claim 12, wherein the tensioning strap extends along an ipsilateral side of the user’s torso when the orthosis is worn by the user.

14. The orthosis of claim 12 or 13, wherein the tensioning strap includes a user-operable tension adjustment mechanism configured to permit incremental tightening and loosening of the tensioning strap.

15. The orthosis of claim 14, wherein the tension adjustment mechanism is a dial-driven lace system comprising a rotatable dial operatively coupled to a spool that winds a tensile element to vary the effective length of the tensioning strap.

16. The orthosis of any one of claims 12 to 15, wherein the tensioning strap is a first tensioning strap, the orthosis further comprising a second tensioning strap extending along a contralateral side of the user’s torso when the orthosis is worn by the user.

17. The orthosis of claim 16, further comprising a third tensioning strap extending along the contralateral side of the user’s torso when the orthosis is worn by the user.

18. The orthosis of claim 17, wherein at least one of the second and third tensioning straps is detachable.

19. The orthosis of any one of claims 17 to 18, wherein at least one of the second and third tensioning straps includes a detachable buckle.

20. The orthosis of any one of claims 1 to 19, further comprising an interior liner secured to the rigid shell.

21. The orthosis of any one of claims 1 to 20, further comprising one or more underarm stabilizers configured to extend between the anterior portion and the posterior portion beneath the user’s armpit when the glenohumeral orthosis is worn.

22. The orthosis of claim 21, wherein the one or more underarm stabilizers are shaped and sized to inhibit upward displacement of the orthosis during use.

23. The orthosis of any one of claims 1 to 22, wherein the rigid shell is substantially conformed to the shoulder of the user using a vacuum forming method.

24. The orthosis of any one of claims 1 to 22, wherein the rigid shell includes at least one of plaster and fiberglass configured to be cast onto the shoulder of the user.

25. The orthosis of any one of claims 1 to 22, wherein the rigid shell is a 3D printed shell substantially conformed to the shoulder of the user.

26. The orthosis of any one of claims 1 to 22, wherein the rigid shell is made of at least one of thermoplastics, nylon and carbon fiber-infused filaments.

27. The orthosis of any one of claims 1 to 22, wherein the rigid shell includes at least one of carbon fiber layers and fiberglass layers infused with a resin.

28. The orthosis of claim 27, wherein the resin is at least one of an epoxy resin and a polyester resin.

29. A method of manufacturing a glenohumeral orthosis, comprising:forming a rigid shell having an inner surface and an outer surface and including an anterior portion and a posterior portion;shaping the rigid shell such that, when worn by a user, the rigid shell is substantially conformed to the user’s shoulder with the anterior portionconfigured to overlie a subcoracoid region of the user and the posterior portion configured to overlie at least a back portion of the user while maintaining clearance about a glenohumeral joint;disposing an interior-facing abutment on the inner surface along the anterior portion and positioned to be aligned with the subcoracoid region when the orthosis is worn, the interior-facing abutment being configured to apply inward pressure to the subcoracoid region when the orthosis is worn;and setting a horizontal spacing between the anterior portion and the posterior portion to achieve a target pressure at the subcoracoid region when the orthosis is worn.

30. The method of claim 29, wherein disposing the interior-facing abutment comprises integrally forming a pressure-applying protrusion on the inner surface of the anterior portion.

31. The method of claim 29, wherein disposing the interior-facing abutment comprises securing a separately formed pad insert to the inner surface of the anterior portion.

32. The method of any one of claims 29 to 31, wherein forming the rigid shell comprises one or more of: vacuum forming a thermoplastic over a model of the user’s shoulder, casting a curable composite over the user, or additively manufacturing the shell from scan-derived anatomical data.

33. The method of any one of claims 29 to 32, further comprising, after fitting the orthosis to the user, actuating a user-operable tension adjustment mechanism disposed along an ipsilateral side of the orthosis to vary a tension in a tensioning strap until a target inward pressure applied by the interior-facing abutment at the subcoracoid region of the user is achieved.

34. The method of claim 33, wherein actuating the tension adjustment mechanism comprises rotating a dial to wind or unwind a tensile element of a dial-driven lace system to increase or decrease the pressure applied by the interior-facing abutment.

35. The method of claim 33 or 34, wherein the tension adjustment mechanism is operable while the orthosis is worn to adjust the pressure without removing the orthosis.

Images