Acromial Fracture Repair System

Abstract

To provide a device to be used for reconstruction of fatigue fracture / insufficiency fracture of acromion and scapula which could occur after reverse type total shoulder arthroplasty.SOLUTION: A kit includes: (1) a plate configured to be secured to a scapular spine with a first end of the plate near a trigonum and a second end of the plate near an acromion; (2) a first hook including a mount, a first hook portion extending from the mount in a first direction, a spacer extending from the first hook portion in a transverse direction, and a second hook portion extending from an opposite end of the spacer in the first direction, the first hook adapted to extend around a lateral end of the acromion when fixed to the second end of the plate; and (3) a second hook including a mount, a curved portion curving away from the mount, and a hook portion at an opposite end of the curved portion, the second hook adapted to extend around the trigonum when fixed to the first end of the plate.SELECTED DRAWING: Figure 5E

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application is an International Patent Application (PCT) related to and claims the benefit of commonly filed, co-pending U.S. Provisional Patent Application No. 62 / 883,414, filed August 6, 2019, and entitled "ACROMION FRACTURE REPAIR SYSTEM," the contents of both of which are incorporated herein by reference.

[0002] The field of the invention relates to orthopedic devices, and more particularly to devices for use in reconstruction of stress / insufficiency fractures of the acromion and scapula that may occur after reverse total shoulder arthroplasty. [Background technology]

[0003] Reverse total shoulder arthroplasty (rTSA) is a surgical procedure that replaces the natural shoulder ball-and-socket joint (also called an acetabular joint, or ball-and-socket joint), which has a spherical humeral head (i.e., ball) that connects with the glenoid cavity (i.e., socket) of the scapula, with a reverse ball-and-socket joint, which has a glenoid sphere (i.e., ball) implanted in the shoulder and mated with a cup (i.e., socket) implanted in the humerus. Occasionally, stress fractures / incomplete fractures of the acromion and scapula occur after rTSA. Reconstruction of stress fractures / incomplete fractures of the acromion and scapula after rTSA is a challenging and unsolved problem. These fractures cannot always be reduced, and healing after reduction is not always reproducible, even among the best shoulder and trauma specialists, due to highly variable anatomy, often composed of relatively thin bone with low blood vessels. There is no ideal method for repairing stress fractures of the acromion and scapula; open reduction and internal fixation (ORIF) is the only currently available solution. When ORIF is used, shoulder specialists and trauma surgeons primarily use locking screws, compression screws, and / or a combination of each, along with one or more linear / noncontoured plates. Because the anatomy of the scapula varies greatly in size, shape, and contour, few anatomically contoured plates are available, and surgeons are often required to bend linear plates to achieve a better fit. Due to concerns about repair and healing, the most common treatment is to immobilize the patient's arm in a sling until the fracture heals. The speed of healing is unpredictable with either ORIF or fixation. Figure 1A shows a representative radiographic image of the shoulder joint after rTSA, before the scapular fracture, and Figure 1B shows a representative radiographic image of the shoulder joint after rTSA, after the scapular fracture.

[0004] Recently, outcome studies of rTSA have demonstrated that even when stress / insufficiency fractures heal, patients do not achieve the level of outcome and function they experienced before the fracture. When fractures do not heal, outcomes are poor because the middle deltoid origin is on the acromion and the posterior deltoid origin is on the lateral acromion and scapular spine. Without proper deltoid function, the reverse shoulder joint cannot generate the torque necessary for activities of daily living, and joint stability is compromised.

[0005] Stress fractures / incomplete fractures of the acromion and scapula can occur any time after the initial rTSA procedure, as early as the first day of surgery and as late as 10 years or more after the procedure. Stress fractures / incomplete fractures of the acromion and scapula after rTSA can occur at various locations on the acromion and scapular spine. These fractures have been classified as Type 1 (fracture of the lateral acromion with deltoid avulsion), Type 2 (fracture of the mid-scapular process at or around the scapular notch), and Type 3 (fracture of the base of the scapular spine). Figures 2A, 2B, and 2C show the superior, posterior, and superior oblique views, respectively, of the portion of the acromion that fractures as a result of these different types of fractures. Figures 3A and 3B show the superior and posterior views, respectively, of a healthy scapula. Figures 3C and 3D show the superior and posterior views, respectively, of a scapula that has experienced a Type 1 fracture. Figures 3E and 3F show the superior and posterior views, respectively, of a scapula that has experienced a Type 2 fracture. Figures 3G and 3H show superior and posterior views, respectively, of a scapula with a Type 3 fracture. The incidence of stress / insufficiency fractures of the acromion and scapula after rTSA is relatively low, generally reported at 1–10%. Type 2 fractures are the most common type of scapular insufficiency fracture after rTSA.

[0006] There are numerous possible causes of these acromion and scapular insufficiency / stress fractures. Some believe the fracture propagates from the distal plate screw to the scapular spine; others hypothesize that the fracture occurs due to overactivity or vigorous exercise and / or traumatic events; and still others believe that the fracture occurs due to excessive tension on the deltoid muscle and / or arm extension as a function of excessive joint packing with an implant that is too thick or too distal for a given patient's anatomy. Furthermore, the use of biomechanically inefficient implants with too small a deltoid moment arm (resulting in too much deltoid force to elevate a particular patient's arm) may be a factor. Additionally, adverse biomechanical anatomical / morphological factors, such as a thin scapula or acromion, osteoporosis or osteopenia, the presence of scapular or CTA lesions, and insufficient scapular overhang or muscle mass resulting in abnormal physiological loading during everyday activities, may also be unique to patients predisposed to these types of insufficiency fractures. Patients with rTSA have greater scapular motion than non-rTSA patients, and the amount of scapular rotation may influence this complication. The timing and intensity of the rehabilitation program may also contribute to the rate and severity of stress fractures / insufficiency fractures of the acromion or scapula. These fractures may also be caused by retractor traction during surgery to expose the glenoid cavity. Regardless of the specific cause (or combination of causes), the patient population is primarily female, osteoporotic, and elderly. As a result of these factors, fractures are less likely to heal, and the patient's quality of health and comorbidities also affect the quality of fracture reconstruction and the rate and probability of fracture healing over time.

[0007] Since its approval in the United States in 2003, rTSA has been widely used worldwide, and the lack of an established solution for this type of complication highlights the need for a better solution for acromion / scapula insufficiency fractures after rTSA, but also for fracture reconstruction failure, which has been reported at a relatively high rate due to patient and anatomical factors. For these reasons, more effective solutions are needed to restore function and stability in patients with rTSA after acromion / scapula insufficiency / stress fractures. Summary of the Invention

[0008] Exemplary embodiments relate to devices for acromion / scapula fracture repair. In some embodiments, the devices described herein are suitable for use in reconstructing the acromion and scapula in rTSA patients with insufficiency fractures of the acromion or scapula.

[0009] In one embodiment, the scapular repair device comprises: a fracture fixation bone plate (referred to herein as a "plate" for brevity) having a first end, a second end opposite the first end, and at least one fixation point disposed along the plate between the first end and the second end; at least one hook, each of the at least one hook attached to a corresponding one of the at least one fixing points of the plate; and each of the at least one fixation element is positioned to secure a corresponding one of the at least one hook to a corresponding one of the at least one fixation points and secure the plate to the patient's scapula; When the plate is secured to the patient's scapula, the plate is configured so that the plate extends along at least a portion of the scapular spine of the scapula and at least a portion of the acromion of the scapula; When the plate is secured to the patient's scapula, the plate and at least one hook are configured to cooperate to hold the acromion and / or scapula in a desired position. In some embodiments, such retention of the acromion and / or scapula is suitable for promoting healing of a fracture, such as one of the three different fracture types that occur after rTSA (e.g., as described above with reference to Figures 3A-3H).

[0010] In one embodiment, the kit comprises: at least one plate having a first end, a second end opposite the first end, and at least one fastening point disposed along the plate between the first end and the second end; a plurality of hooks, each of the plurality of hooks configured to be secured to a securing point of a selected one of the at least one plate; a plurality of fixation elements, each configured to secure a selected one of the plurality of hooks to a selected one of the at least one fixation points of a selected one of the at least one plates to secure the selected one of the at least one plates to a scapula of the patient; Including, each at least one plate is configured such that when the at least one plate is secured to the patient's scapula, the at least one plate extends along at least a portion of the scapular spine of the scapula and at least a portion of the acromion of the scapular spine; Each of the at least one plates and each of the at least one hooks are configured such that when a selected one of the at least one hook is secured to a selected one of the at least one plate and the selected one of the at least one plate is secured to a patient's scapula, the selected one of the at least one plate and the selected one of the at least one hook cooperate to hold the acromion in a desired position.

[0011] In some embodiments, the kit includes at least one plate and a plurality of hooks, each of the at least one plate including a plurality of fixation points spaced (or spaced) along each of the at least one plate, the at least one plate including at least a first plate that is an elongated (or elongated) plate having a first end and a second end opposite the first end, the first plate including an elongated plate opposite the first end and the second end, the first plate configured to be secured to the scapular spines, the first end proximate a trigonum of the scapula and the second end proximate an acromion of the scapula, and the first plate sized and shaped to extend along the scapular spines of the patient. wherein each of the hooks is configured to be fixed to one selected one of the fixation points of at least one plate, and the plurality of hooks includes at least a first hook including: (1) an attachment portion configured to be fixed to one selected one of the fixation points of the at least one plate, (2) a first hook portion located proximate to the attachment portion and extending away from the attachment portion in a first direction, and the plurality of hooks is as follows: (3) a spacer portion extending away from the first hook portion in a lateral direction perpendicular to the first direction, and (4) a second hook portion extending from an end of the spacer portion opposite the first hook portion and extending in the first direction, wherein the first and second hook portions are sized and shaped to extend around the lateral end of the acromion when the first hook is fixed to the first plate proximate to the second end of the fixation points of the first plate. and providing a second hook including: (1) a mounting portion configured to be secured to a selected one of the fixing points of the at least one plate; (2) a curved portion extending away from the mounting portion and curved toward the mounting portion; and (3) a hook portion at an end of the curved portion opposite the mounting portion of the second hook.Here, the second hook is sized and shaped such that when the second hook is secured to a second one of the securing points of the first plate proximate the first end of the first plate, the hook portion of the second hook is configured to extend around the triangular portion of the scapula.

[0012] In some embodiments, the first plate is contoured to fit the scapular spine.

[0013] In some embodiments, at least one of the at least one plates is adaptable to allow a user to adapt the plate to a portion of the scapula.

[0014] In some embodiments, the hook portion of the second hook is Y-shaped.

[0015] In some embodiments, the first plate, the first hook, and the second hook are configured to cooperate to apply a compressive force to a fracture along the scapular spine when: (a) the first plate is secured to the scapular spine; (b) the first hook is secured to a first one of the fixation points of the first plate and the first and second hook portions of the first hook are positioned to extend around the lateral edge of the acromion; and (c) the second hook is secured to a second one of the fixation points of the first plate and the hook portion of the second hook is positioned to extend around the triangular portion of the scapula.

[0016] In some embodiments, the kit also includes at least one fastener configured to be secured to one of the fixation points of one of the at least one plate and to the scapula to secure one of the at least one plates to the scapula.

[0017] In some embodiments, the kit also includes at least one fastener configured to be secured to one of the securing points of one of the at least one plate and to a selected one of the plurality of hooks to secure a selected one of the plurality of hooks to one of the at least one plate.

[0018] In some embodiments, the at least one plate also includes a second plate having a first end and a second end opposite the first end of the second plate, the second plate being a curved plate that is sized and shaped to be positioned adjacent to the patient's spines of the scapula and the patient's acromion such that the first end of the second plate is positioned proximate the patient's triangular region and the plate extends along the patient's acromion and the patient's spines of the scapula to the second end that is positioned proximate the apex of the patient's acromion.

[0019] In some embodiments, the second hook is sized and shaped such that when the second hook is secured to one of the fixation points of the second plate located proximate the second end of the second plate, the hook portion of the second hook is configured to extend around the apex of the patient's acromion.

[0020] In some embodiments, the at least one plate includes a second plate that is an elongated plate having a first end and a second end opposite the first end of the second plate, the second plate being sized and shaped to be positioned along the scapular spines and configured to extend along the scapular spines from the first end positioned along the underside of the scapular spines to the second end positioned along the posterior surface of the acromion. In some embodiments, the plurality of hooks includes a third hook including: (1) an attachment portion configured to be secured to a selected one of the selected one of the fixation points of the at least one plate; (2) a curved portion extending away from the attachment portion and curved toward the attachment portion; (3) a hook portion at an end of the curved portion opposite the attachment portion of the second hook; and (4) a fixation hole extending through the hook portion, the fixation hole configured to receive a fastener to secure the hook portion to the scapula. In some embodiments, the third hook is sized and shaped so that when the second plate is positioned along the scapular spine and the second hook is secured to one of the fixation points of the second plate positioned along the underside of the scapular spine, the hook portion extends over the superior surface of the scapular spine. In some embodiments, the kit also includes a fastener configured to be secured to both the attachment portion and the fixation hole of the third hook. In some embodiments, when (a) the second plate is positioned along the scapular spine and (b) the third hook is secured to one of the fixation points of the second plate positioned along the underside of the scapular spine, the fastener is configured to extend through the attachment portion, the scapular spine, and the fixation hole of the third hook so that the hook portion of the third hook extends over the superior surface of the scapular spine.

[0021] In some embodiments, the method comprises: (1) providing a kit including at least one plate, a plurality of hooks, and a plurality of fasteners; (2) fastening the first hook to a first one of the fastening points of the first plate using a first fastener of the plurality of fasteners; (3) fastening a second hook to a second one of the fastening points of the first plate using a second fastener of the plurality of fasteners; (4) positioning the first plate along the scapular spine of the patient's scapula so that the first end is adjacent the triangular portion of the scapula and the second end is adjacent the acromion of the scapula; and (5) securing the first plate, the first hook, and the second hook to the scapular spine with at least a third fastener of the plurality of fasteners such that the first hook extends around the lateral edge of the acromion, the second hook extends around the triangular portion, and the first plate, the first hook, and the second hook cooperate to apply a compressive force along the scapular spine. Including, each of the at least one plate includes a plurality of fixation points spaced (or spaced) along each of the at least one plate, the at least one plate including at least one first plate that is an elongated plate having a first end and a second end opposite the first end; the first plate is sized and shaped to be positioned and extend along the scapular spine of the patient's scapula, such that a first end is adjacent the triangular portion of the scapula and a second end is adjacent the acromion of the scapula and is configured to be secured to the scapular spine; each of the hooks is configured to be secured to a selected one of the securing points of the at least one plate; a first hook of the plurality of hooks including: (a) an attachment portion configured to be secured to a selected one of the selected one of the fixation points of at least one plate; (b) a first hook portion disposed proximate the attachment portion and extending away from the attachment portion in a first direction; (c) a spacer portion extending away from the first hook portion in a lateral direction perpendicular to the first direction; and (d) a second hook portion extending from an end of the spacer portion opposite the first hook portion and extending in the first direction; wherein the first hook is sized and shaped to be configured such that when the first hook is secured to a first of the fixation points of the first plate proximate the second end of the plate, the first and second hook portions extend around the lateral end of the acromion; a second hook of the plurality of hooks includes: (a) a mounting portion configured to be secured to a selected one of the selected one fixing points of the at least one plate; (b) a curved portion extending away from the mounting portion and curved toward the mounting portion; and (c) a hook portion at an end of the curved portion opposite the mounting portion of the second hook; The second hook is sized and shaped so that when the second hook is secured to a second one of the securing points of the first plate proximate the first end of the first plate, the hook portion of the second hook is configured to extend around the triangular portion of the scapula. [Brief explanation of the drawings]

[0022] Several embodiments of the present invention are described herein, by way of example only, with reference to the accompanying drawings. Referring now specifically to the drawings in detail, it is emphasized that the specific details shown are by way of example for illustrative discussion of embodiments of the invention. In this regard, the description taken together with the drawings will make apparent to those skilled in the art how embodiments of the invention may be practiced.

[0023] [Figure 1A] Anterior-posterior radiograph of the shoulder joint after rTSA and before scapular fracture. [Figure 1B] FIG. 1B shows the rTSA shoulder joint from FIG. 1A after a scapular fracture. [Figure 2A] FIG. 1 shows a top view of different scapular fracture locations. [Figure 2B] FIG. 2B is a posterior view of the scapular fracture shown in FIG. 2A. [Figure 2C] FIG. 2B is a superior perspective view of the scapular fracture shown in FIG. 2A. [Figure 3A] FIG. 1 is a top view of a healthy scapula. [Figure 3B] FIG. 3B is a posterior view of the healthy scapula shown in FIG. 3A. [Figure 3C] Superior view of the scapula after a Type 1 fracture. [Figure 3D] FIG. 3D is a posterior view of the fractured scapula shown in FIG. 3C. [Figure 3E] Superior view of the scapula after a type 2 fracture. [Figure 3F] FIG. 3C is a posterior view of the fractured scapula shown in FIG. 3E. [Figure 3G] Superior view of the scapula after a type 3 fracture. [Figure 3H] FIG. 3C is a posterior view of the fractured scapula shown in FIG. 3G. [Figure 4A] 1 illustrates a first exemplary modular hook. [Figure 4B] 1 illustrates a second exemplary modular hook. [Figure 4C] 10 illustrates a third exemplary modular hook. [Figure 4D] 4D shows two of the third exemplary modular hooks of FIG. 4C attached to an exemplary base. [Figure 5A] 1 shows a first exemplary plate. [Figure 5B] FIG. 5B is a back view of the first exemplary plate of FIG. 5A. [Figure 5C] 5B illustrates the first exemplary plate of FIG. 5A as configured with exemplary hooks. [Figure 5D] FIG. 5D is a back view of the exemplary plate and exemplary hook of FIG. 5C. [Figure 5E] FIG. 5D shows the first exemplary plate and exemplary hook of FIG. 5C secured to a representative scapula. [Figure 5F] FIG. 5E is another view of the first exemplary plate and exemplary hook of FIG. 5D and a representative scapula. [Figure 6A] FIG. 10 is a perspective view of a second exemplary plate. [Figure 6B] FIG. 6B is a reverse perspective view of the second exemplary plate of FIG. 6A. [Figure 6C] 6B illustrates the second exemplary plate of FIG. 6A as configured with exemplary hooks. [Figure 6D] 6D is another view of the second exemplary plate and exemplary hook of FIG. 6C. [Figure 6E] 6C and 6D are shown as secured to a representative scapula. [Figure 6F] FIG. 6F is another view of the second exemplary plate and exemplary hook of FIG. 6E and an exemplary scapula. [Figure 7A] 1 shows a third exemplary plate. [Figure 7B] FIG. 7B is a back view of the third exemplary plate of FIG. 7A. [Figure 7C] 7B illustrates the third exemplary plate of FIG. 7A as configured with exemplary hooks. [Figure 7D] 7D is another view of the third exemplary plate and exemplary hook of FIG. 7C. [Figure 7E] 7C and 7D show the third exemplary plate and exemplary hook as secured to a representative scapula. [Figure 7F] FIG. 7F is another view of the third exemplary plate, exemplary hook, and exemplary scapula of FIG. 7E. [Figure 8A] 10 shows a fourth exemplary plate that is an adjustable plate. [Figure 8B] 8C illustrates another configuration of the fourth exemplary plate of FIG. 8B. [Figure 8C] FIG. 8B shows the fourth exemplary plate of FIG. 8A with its scapular plate positioned in two alternative positions. [Figure 8D]8A and 8B positioned with reference to a representative scapula. [Figure 8E] FIG. 8E is another view of the fourth exemplary plate and representative scapula of FIG. 8D. DETAILED DESCRIPTION OF THE INVENTION

[0024] Exemplary embodiments relate to a fracture fixation system for patients with acromion and scapula fractures following rTSA. In some embodiments, the exemplary fracture fixation system restores stability to a shoulder with a fractured acromion and / or scapula through the use of a scapular plating system including at least one modular hook that secures around at least one corresponding anatomical scapular feature (e.g., the acromion, scapular spine, or scapular triangle). In some embodiments, the at least one hook is integral with the plate (e.g., integrally formed from a single piece of plate material). In some embodiments, the at least one hook is modularly secured to the plate using a mechanical locking mechanism. In some embodiments, the plate construct (e.g., a plate including at least one integrally formed hook, a plate including at least one modularly attached hook, etc.) may be secured to the scapula with the aid of screws, sutures, wires, and / or pins.

[0025] In some embodiments, the plate used in conjunction with at least one modular hook facilitates simpler surgical techniques through smaller incisions while improving the availability of multiple and varied anatomical size ranges (e.g., by providing modular hooks of various shapes and sizes) to account for variable scapular anatomies / morphologies, thereby reducing the overall range and kit cost required to account for anatomical variability required in global markets. In some embodiments, the plate used in conjunction with at least one modular hook simplifies the manufacturing process and requires lower costs for all implants in the kit (e.g., by allowing for mixing and matching of different configurations).

[0026] In some embodiments, the plate used in conjunction with at least one modular hook can be positioned at morphologically / anatomically strategic locations on the bone to accommodate each patient's individual fracture type (e.g., Type 1, 2, or 3). For example, such modular hooks can be positioned on the lateral acromion (see, e.g., Figures 5E and 5F) or toward the medial portion of the acromion. Figures 5E and 5F also show these holes anchored along the medial scapular border, at or around the scapular triangle. Similarly, the modular hooks can be positioned along the anterior portion of the acromion (see, e.g., Figures 6E and 6F) or alternatively toward the posterior portion of the acromion, if the orthopedic surgeon / traumatologist deems that location to promote the best reconstruction. Similarly, the plate and modular hooks can be anchored to the scapular spine above, below, or along the lateral side of the scapular spine (see, e.g., Figures 7A-7F). In some embodiments, the plates themselves are modular (see, e.g., Figures 8A-8E) and can be used in conjunction with modular hooks for even more complex morphological variability or to better support the comminution of complex fractures. In some embodiments, such modular connections can have variability in angle / tilt, as well as rotation and position.

[0027] In some embodiments, holes for screw fixation can be positioned in different positions and orientations on the plate to facilitate reconstruction and compression across the fracture line and to provide additional stability for each of the different fracture types. In some embodiments, these modular hooks can also accept screws for additional fixation (see, e.g., FIGS. 4C and 4D). Furthermore, in some embodiments, multiple holes of various sizes for sutures and wires can be designed to facilitate reconstruction. In some embodiments, the size of such holes is selected to allow needles of various sizes to easily pass through them while the plate is compressed against the bone. In some embodiments, the edges of the suture holes are configured to prevent fraying of the sutures as they are secured to the plate.

[0028] In some embodiments, the exemplary plates and modular hooks are provided in several different sizes and shapes to accommodate the various acromion and scapula fracture types that orthopedic surgeons may present with after rTSA, i.e., Type 1, Type 2, and Type 3 scapular fractures as described above. The figures accompanying the exemplary embodiments show several views of different design variations of the proposed device to account for different possible fracture locations. For example, as shown in Figures 5E, 5F, 6E, 6F, 7E, and 7F, for Type 1 or Type 2 fractures, the modular hooks may be positioned laterally to the acromion, along or around different regions of the acromion, and / or in different locations (e.g., posterior, anterior, or medial to the scapula, etc.). Conversely, for Type 2 or Type 3 fractures such as those shown in Figures 5E, 5F, 7E, and 7F, the modular hooks may be placed above or below the scapular spine, on the medial side of the scapula, in or around the scapular triangle, and / or in a different location (e.g., posterior, anterior, or medial side of the scapula, etc.).

[0029] In some embodiments, the exemplary plates and modular hooks are provided in multiple different shapes and sizes for each fracture type, and within a range of sizes and shapes to account for the normal anatomical variations of the acromion and scapular spine. For example, as shown in Figures 5B-5D and 6C-6F, the exemplary plates and modular hooks may be configured to secure to the superior aspect of the scapular spine and acromion and then rotate to the lateral or inferior aspect of the scapular spine for additional multiplanar support. Conversely, as shown in Figures 7C-7F, the exemplary plates may be placed superior to the scapular spine and rotated to the inferior aspect of the acromion. In some embodiments, different extensions and shapes are configured or modularly attached to provide multiple and varied options and positions for screw / suture / wire fixation to the scapula.

[0030] 4A is a perspective view of a first exemplary hook 400 that may form part of an exemplary acromion / scapula fracture repair system. In some embodiments, the hook 400 is sized and shaped for fixation adjacent the lateral acromion. In some embodiments, the hook 400 includes an attachment portion 402 configured to attach the hook 400 to a plate, a first hook portion 404 adjacent the attachment portion 402, a spacer portion 406 extending away from the first hook portion 404, and a second hook portion 408 at the end of the spacer portion 406 opposite the first hook portion 404.

[0031] 4B is a perspective view of a second exemplary hook 410 that may form part of an exemplary acromion / scapula fracture repair system. In some embodiments, the hook 410 is sized and shaped to secure adjacent the medial scapula near the triangular portion. In some embodiments, the hook 410 is sized and shaped to secure above the acromion. In some embodiments, the hook 410 includes a mounting portion 412 configured to attach the hook 410 to a plate, a curved portion 414 extending away from and curving toward the mounting portion 412, and a Y-shaped hook portion 416 at the end of the curved portion 414 opposite the mounting portion 412.

[0032] FIG. 4C is a perspective view of a third exemplary hook 420 that may form part of an exemplary acromion / scapula fracture repair system. In some embodiments, the hook 420 is sized and shaped for fixation along the scapular spine. In some embodiments, the hook 420 includes an attachment portion 422 configured to attach the hook 420 to a plate, a curved portion 424 extending away from the attachment portion 422 and curving back toward the attachment portion 422, a hook portion 426 at the end of the curved portion 424 opposite the attachment portion 422, and a fixation hole 428 extending through the hook portion 426 and configured to receive an attachment element (e.g., a screw) extending therethrough to provide improved fixation. FIG. 4D is a perspective view showing a portion of an exemplary plate 430 and two of the third exemplary hooks 420. As shown in FIG. 4D , in some embodiments, for each exemplary hook 420, a screw 440 is attached through a hole 432 in the plate 430, the mounting portion 422 of the hook 420, and the fixing hole 428 of the hook 420, thereby securing the exemplary hook 420 to the plate 430.

[0033] 5A and 5B are perspective views of a first exemplary plate 500. In some embodiments, the plate 500 is sized and shaped to be positioned along the patient's scapular spine. In some embodiments, the plate 500 includes a first end 502 (e.g., a medial end) and a second end 504 (e.g., a lateral end). In some embodiments, the plate 500 includes a plurality of fixation points 506 (e.g., holes) extending therethrough and configured to facilitate fixation of the plate 500 to bone by mechanical fixation devices such as screws, sutures, wires, pins, etc. In the embodiment of the plate 500 shown in FIGS. 5A and 5B, the plate 500 includes ten fixation points 506, although this number is illustrative only and one skilled in the art will appreciate that the plate 500 may include any number of fixation points 506.

[0034] 5C and 5D are perspective views of a plate 500 constructed for fixation to a patient's scapula. As shown in FIGS. 5C and 5D, the plate 500 has been constructed by securing one of the second exemplary hooks 410 to a first end 502 and one of the first exemplary hooks 400 to a second end 504. In some embodiments, as shown in FIGS. 5C and 5D, the first exemplary hook 400 and the second exemplary hook 410 are secured to the plate 500 by screws 510. The combination of the plate 500, the first exemplary hook 400, the second exemplary hook 410, and the screws 510 is referred to herein as a construct 520.

[0035] 5E and 5F are perspective views of a representative scapula S with a construct 520 secured thereto. FIG. 5E is a posterior view, and FIG. 5F is an anterior view. As shown in FIGS. 5E and 5F, the second exemplary hook 410 extends around the medial scapula near the deltoid, the plate 500 extends along the scapular spine, and the first exemplary hook 400 extends around the lateral acromion. In some embodiments, a screw 510 extends into the scapula to secure the construct 520 thereto. In some embodiments, the first exemplary hook 400, the plate 500, the second exemplary hook 410, and the screw 510 cooperate to hold the acromion in a desired (e.g., anatomically correct) position.

[0036] 6A and 6B are perspective views of a second exemplary plate 600. In some embodiments, the plate 600 is sized, shaped, and curved to extend along the patient's scapular spine and acromion. In some embodiments, the plate 600 includes a first end 602 (e.g., a medial end) and a second end 604 (e.g., a lateral end). In some embodiments, the plate 600 includes a plurality of fixation points 606 (e.g., holes) extending therethrough and configured to facilitate fixation of the plate 600 to bone by mechanical fixation devices such as screws, sutures, wires, pins, etc. In the embodiment of the plate 600 shown in FIGS. 6A and 6B, the plate 600 includes thirteen fixation points 606, although this number is illustrative only and one skilled in the art will appreciate that the plate 600 may include any number of fixation points 606.

[0037] 6C and 6D are perspective views of a plate 600 constructed for fixation to a patient's scapula. FIG. 6C is a posterior perspective view, and FIG. 6D is an anterior perspective view. As shown in FIGS. 6C and 6D, the plate 600 was constructed by securing one of the third exemplary hooks 420 to the second end 604. In some embodiments, as shown in FIGS. 6C and 6D, the third exemplary hook 420 is secured to the plate 600 by a screw 610. The combination of the plate 600, the third exemplary hook 420, and the screw 610 is referred to herein as a construct 620.

[0038] 6E and 6F are perspective views of a representative scapula S with a construct 620 secured thereto. FIG. 6E is a posterior view, and FIG. 6F is a lateral view. As shown in FIGS. 6E and 6F, the plate 600 extends along the scapular spine and curves to extend along the acromion, and the third exemplary hook 420 extends around the top of the acromion. In some embodiments, the screw 610 extends through the acromion to secure the construct 620 thereto. In some embodiments, the plate 600, the third exemplary hook 420, and the screw 610 cooperate to hold the acromion in a desired (e.g., anatomically correct) position.

[0039] 7A and 7B are perspective views of a third exemplary plate 700. In some embodiments, plate 700 is sized, shaped, and curved to extend along the patient's scapular spine and acromion. In some embodiments, plate 700 includes a first end 702 (e.g., a medial end) and a second end 704 (e.g., a lateral end). In some embodiments, plate 700 is curved such that when plate 700 is positioned adjacent the patient's scapula, first end 702 is positioned along the underside of the scapular spine and second end 704 is positioned along the posterior side of the acromion. In some embodiments, plate 700 includes multiple fixation points 706 (e.g., holes) extending therethrough and configured to facilitate fixation of plate 700 to bone with mechanical fixation devices such as screws, sutures, wires, pins, etc. In the embodiment of plate 700 shown in Figures 7A and 7B, plate 700 includes eight of fastening points 706, however, it will be apparent to one skilled in the art that this number is merely exemplary and that plate 700 may include any number of fastening points 706.

[0040] 7C and 7D are perspective views of a plate 700 constructed for fixation to a patient's scapula. FIG. 7C is a posterior perspective view, and FIG. 7D is an anterior perspective view. As shown in FIGS. 7C and 7D, the plate 700 was constructed by securing a first hook of the third exemplary hook 420 to the first end 702, a second hook of the third exemplary hook 420 intermediate the first and second ends 702, 704, and a third hook of the exemplary hook 420 to the second end 704. In some embodiments, as shown in FIGS. 7C and 7D, the third exemplary hook 420 is secured to the plate 700 by a screw 710. The combination of the plate 700, the third exemplary hook 420, and the screw 710 is referred to herein as a construct 720.

[0041] 7E and 7F are perspective views of a representative scapula S with a construct 620 secured thereto. As shown in FIGS. 7E (posterior view) and 7F (posterior perspective view), the plate 700 is curved to extend from a first end 702 of the plate 700 along the underside of the scapula and along the posterior side of the scapula and acromion, extending toward a second end 704 of the plate 700. The first and second hooks of the third exemplary hook 420 secure the plate 700 to the scapula, and the third hook of the exemplary hook 420 secures the plate to the acromion. In some embodiments, a screw 710 extends through the scapula and acromion and secures the construct 710 thereto. In some embodiments, the plate 700, the exemplary hook 420, and the screw 710 cooperate to hold the acromion in a desired (e.g., anatomically correct) position.

[0042] 8A and 8B are perspective views of a fourth exemplary plate 800. The fourth exemplary plate 800 is an adjustable plate. FIGS. 8A and 8B show the fourth exemplary plate 800 from substantially the same perspective, with the plate 800 shown adjusted to a first position in FIG. 8A and a second position in FIG. 8B. Plate 800 includes a scapula plate 810, an acromion plate 820, and a modular joint 830 connecting the acromion plate and the scapula plate. In some embodiments, the modular joint is a spherical joint that allows adjustment of the joint angle between the scapula plate 810 and the acromion plate 820, thereby allowing the position of the acromion plate 820 to account for each patient's acromion morphology and bone shape (e.g., acromion slope). In some embodiments, the modular joint 830 can be secured / clamped, for example, with a screw, thereby fixing the positions of the scapula plate 810 and the acromion plate 820 relative to each other. In some embodiments, the scapula plate 810 is sized and shaped to extend along the patient's scapular spines. In some embodiments, the acromion plate 820 is sized and shaped to extend along the patient's scapular spines. In some embodiments, the plate 800 includes a plurality of fixation points 840 (e.g., holes) extending therethrough and configured to facilitate fixation of the plate 800 to bone by mechanical fixation devices such as screws, sutures, wires, pins, etc. In the embodiment of the plate 800 shown in FIGS. 8A and 8B , the plate 800 includes 12 fixation points 840, with 9 fixation points 840 located along the scapula plate 810 and 3 fixation points 840 located along the acromion plate 820; however, it will be apparent to one skilled in the art that this number is merely exemplary and that the plate 800 may include any number of fixation points 840. In some embodiments, plate 800 is configured to allow any of the exemplary hooks discussed herein (e.g., first exemplary hook 400, second exemplary hook 410, and / or third exemplary hook 420) to be secured thereto to facilitate fixation to the scapula.

[0043] Figure 8C is a side view of the exemplary plate 800 of Figures 8A and 8B. In the view of Figure 8C, the acromion plate 820 is shown positioned in two alternative positions 820A and 820B relative to the scapula plate 810. From Figure 8C, it can be seen that the adjustable positioning of the acromion plate 820 allows the exemplary plate 800 to be adjusted to properly fit patients with various anatomies, for example, different angles of the acromion.

[0044] 8D and 8E are perspective views of a representative scapula S with plate 800 positioned adjacent thereto. While FIGS. 8D (posterior view) and 8E (posterior perspective view) show plate 800 without any hooks (e.g., first exemplary hook 400, second exemplary hook 410, and / or third exemplary hook 420) and screws (or other similar fixation mechanisms), it will be apparent to those skilled in the art that these figures are illustrative only and that an actual application of exemplary plate 800 may include such additional elements. As shown in FIGS. 8D and 8E, scapular plate 810 extends along the superior side of the scapular spine, modular joint 830 is positioned proximate the base of the acromion, and acromion plate 820 extends along the acromion. In some embodiments, plate 800 is configured to be used with one or more hooks (e.g., first exemplary hook 400, second exemplary hook 410, and / or third exemplary hook 420) and screws to hold the acromion in a desired (e.g., anatomically correct) position.

[0045] In some embodiments, the exemplary device is provided in several different sizes and shapes to account for the various fracture types an orthopedic surgeon may encounter. In some embodiments, the exemplary device is provided in different shapes for the different types of scapular fractures discussed above (i.e., Type 1 fractures, as shown in Figures 3C and 3D, Type 2 fractures, as shown in Figures 3E and 3F, and Type 3 fractures, as shown in Figures 3G and 3H), each corresponding to a fracture at a different location within the scapula.

[0046] In some embodiments, the device includes one or more extensions or shapes to provide multiple options for screw fixation to the scapula to enhance fixation to the native bone. In some embodiments, such extensions are integrally formed with the exemplary scapula fixation device. In some embodiments, such extensions are modularly attachable to and detachable from the exemplary scapula fixation device. In some embodiments, at least one such extension is configured to provide an option for screw fixation facing upwardly of the scapula spine. In some embodiments, at least one such extension is configured to provide an option for screw fixation facing downwardly of the scapula spine. In some embodiments, at least one such extension is configured to provide an option for screw fixation adjacent the medial border to the superior side of the scapula spine. In some embodiments, at least one such extension is configured to provide an option for screw fixation adjacent the medial border to the inferior side of the scapula spine.

[0047] It should be noted that each of the exemplary embodiments described herein can be fixed to one or more areas of the acromion or scapular spine to provide additional strength and rigidity at the time of initial reverse shoulder arthroplasty (i.e., before a fracture occurs). By prophylactically fixing such plates to areas of the scapula that are exposed to high stress after rTSA, the incidence of acromion and / or scapular fractures after rTSA may be reduced, as any of the exemplary devices may offload the bone and better distribute the load. In some embodiments, a post is fixed between the coracoid and / or clavicle to reduce and better distribute the load (e.g., stress transfer) to other portions of the scapula. In practice, any of the exemplary embodiments described herein can be used individually or in combination with each other at the orthopedic surgeon's discretion to best anatomically reconstruct the fractured bone and achieve fragment compression after a fracture has occurred or prophylactically.

[0048] In some embodiments, any of the exemplary embodiments described above can be manufactured to be bendable or otherwise conform to facilitate further patient-specific shaping and improve initial fixation when repairing the patient's acromion and scapula. In some embodiments, the shape and contour of each of the modular hooks (e.g., first exemplary hook 400, second exemplary hook 410, and / or third exemplary hook 420) may be bendable to better conform to the patient's scapular morphology along either the medial, lateral, anterior, or posterior regions of the scapula. In some embodiments, sutures, tape, anchors, or screws may be used to secure soft tissue to any of the exemplary embodiments described herein. Any of the exemplary embodiments described herein can be manufactured from different biocompatible materials, including Co-Cr, stainless steel, titanium, titanium alloys, carbon fiber-reinforced polymers, ceramics, PMMA bone cement, pyrocarbon, and / or bone grafts. Any of the exemplary embodiments described herein may include surface textures and / or coatings to provide additional mechanical fixation and promote osteointegration. Any of the exemplary embodiments described herein can be fabricated using conventional computer-aided manufacturing processes, forging, casting, injection molding, or additive manufacturing or similar processes. Any of the exemplary embodiments described herein can be designed based on a patient's actual anatomy (or contralateral anatomy) through the use of CT reconstruction and computer modeling. Any of the exemplary embodiments described herein can be treated with surface coatings or various treatments to promote fixation to soft tissue, muscle, and / or bone.

[0049] In some embodiments, the exemplary device is formed from a metal plate that is cut and formed to the desired size and shape. In some embodiments, the plate has a thickness in the range of 3 mm to 10 mm. In some embodiments, the thickness is in the range of 3 mm to 9 mm. In some embodiments, the thickness is in the range of 3 mm to 8 mm. In some embodiments, the thickness is in the range of 3 mm to 7 mm. In some embodiments, the thickness is in the range of 3 mm to 6 mm. In some embodiments, the thickness is in the range of 3 mm to 5 mm. In some embodiments, the thickness is in the range of 3.5 mm to 4.5 mm. In some embodiments, the thickness is approximately 4 mm. In some embodiments, the thickness is 4 mm.

[0050] In some embodiments, the screw holes of exemplary devices have a diameter ranging from 1.0 mm to 4.5 mm. In some embodiments, the screw holes have a diameter ranging from 1.5 mm to 4.0 mm. In some embodiments, the screw holes have a diameter ranging from 2.0 mm to 3.5 mm. In some embodiments, the screw holes have a diameter ranging from 2.5 mm to 3.0 mm. In some embodiments, the screw holes have a diameter ranging from 1.0 mm to 4.0 mm. In some embodiments, the screw holes have a diameter ranging from 1.0 mm to 3.5 mm. In some embodiments, the screw holes have a diameter ranging from 1.0 mm to 3.0 mm. In some embodiments, the screw holes have a diameter ranging from 1.0 mm to 2.5 mm. In some embodiments, the screw holes have a diameter ranging from 1.0 mm to 2.0 mm. In some embodiments, the screw holes have a diameter ranging from 1.0 mm to 1.5 mm. In some embodiments, the screw holes have a diameter ranging from 1.5 mm to 4.5 mm. In some embodiments, the screw holes have a diameter in the range of 2.0 mm to 4.5 mm. In some embodiments, the screw holes have a diameter in the range of 2.5 mm to 4.5 mm. In some embodiments, the screw holes have a diameter in the range of 3.0 mm to 4.5 mm. In some embodiments, the screw holes have a diameter in the range of 3.5 mm to 4.5 mm. In some embodiments, the screw holes have a diameter in the range of 4.0 mm to 4.5 mm.

[0051] In some embodiments, in areas of the device where screw holes are present, the screw holes may be spaced apart from one another by a spacing distance (i.e., measured center-to-center or edge-to-edge). In some embodiments, the spacing distance is between 1.0 cm and 4.0 cm. In some embodiments, the spacing distance is between 1.5 cm and 3.5 cm. In some embodiments, the spacing distance is between 2.0 cm and 3.0 cm. In some embodiments, the spacing distance is between 2.5 cm and 3.5 cm. In some embodiments, the spacing distance is between 1.0 cm and 3.5 cm. In some embodiments, the spacing distance is between 1.0 cm and 3.0 cm. In some embodiments, the spacing distance is between 1.0 cm and 2.5 cm. In some embodiments, the spacing distance is between 1.0 cm and 2.0 cm. In some embodiments, the spacing distance is between 1.0 cm and 1.5 cm. In some embodiments, the spacing distance is between 1.5 cm and 4.0 cm. In some embodiments, the spacing distance is between 2.0 cm and 4.0 cm. In some embodiments, the spacing distance is between 2.5 cm and 4.0 cm. In some embodiments, the spacing distance is between 3.0 cm and 4.0 cm. In some embodiments, the spacing distance is between 3.5 cm and 4.0 cm.

[0052] Unless expressly indicated otherwise in the specification, throughout the specification and claims, the following terms have the meanings expressly associated therewith. As used herein, the phrases "in one embodiment," "in an embodiment," and "in some embodiments" do not necessarily refer to the same embodiment, although they may. Furthermore, as used herein, the phrases "in another embodiment" and "in some other embodiments" do not necessarily refer to different embodiments, although they may. Thus, various embodiments of the invention may be readily combined without departing from the scope or spirit of the invention, as described herein.

[0053] Also, as used herein, the term "based on" is not exclusive and may be based on additional factors not recited, unless the specification expressly indicates otherwise. Also, throughout the specification, the meanings of "a," "an," and "the" include plural referents. The meaning of "in" includes "in" and "on."

[0054] While numerous embodiments of the present invention have been described, it is understood that these embodiments are illustrative only, not limiting, and that numerous variations may become apparent to those skilled in the art. For example, any dimensions discussed herein are provided by way of example only and are intended to be illustrative, not limiting. [Explanation of symbols]

[0055] 400, 410, 420... Hook 402, 412, 422 … Mounting part 404 ... First hook part 406 ... Spacer part 414, 424 ... curved section 416 ... Y-shaped hook part 426 ... Hook part 428 … Fixing hole 430, 500, 600, 700, 800... plates 432 ... Hole 440, 510, 610, 710... screws 502, 602, 702 ... first end 504, 604, 704 ... second end 506, 606, 706, 840 … fixed point 520, 620, 720 … constructs 810 ... Scapular plate 820 ... acromion plate 830 … Modular joints

Claims

1. an elongated plate having a first end and a second end opposite the first end; and At least one hook A device comprising: the elongated plate is sized, shaped, and curvature configured to be positioned and extend along the scapular spine of the patient's scapula and the acromion of the patient's scapula, such that a first end extends toward the scapular triangle and a second end is proximate the superior end of the acromion of the scapula; At least one hook a first hook extending laterally from the elongated plate such that the first hook is configured to extend around the lateral end of the acromion when the elongated plate is secured to the scapular spine; a second hook extending upwardly from the second end of the elongated plate so as to extend around the apex of the acromion when the elongated plate is secured to the scapular spine; or a third hook extending medially from the elongated plate such that the third hook is configured to extend around the scapular triangle when the elongated plate is secured to the scapular spine. A device comprising at least one of:

2. The device of claim 1 , wherein the at least one hook is integrally formed with the elongate plate.

3. The device of claim 1 , wherein the at least one hook is modular.

4. The device of claim 1 , wherein the elongated plate is contoured to fit over the scapular spine.

5. The device of claim 1 , wherein the elongated plate is adaptable to allow a user to fit the elongated plate to a portion of a scapula.

6. 10. The device of claim 1, wherein the elongate plate and the at least one hook are configured to cooperate to apply a compressive force to a fracture along the scapular spine when the elongate plate is secured to the scapular spine.

7. a device comprising an elongate plate having a first end and a second end opposite the first end, and at least one hook; Multiple Fasteners A kit comprising: the elongated plate is sized, shaped, and curvature configured to be positioned and extend along the scapular spine of the patient's scapula and the acromion of the patient's scapula, such that a first end extends toward the scapular triangle and a second end is proximate the superior end of the acromion of the scapula; the elongate plate includes a plurality of fastening points extending therethrough; At least one hook a first hook extending laterally from the elongated plate such that the first hook is configured to extend around the lateral end of the acromion when the elongated plate is secured to the scapular spine; a second hook extending upwardly from the second end of the elongated plate so as to extend around the apex of the acromion when the elongated plate is secured to the scapular spine; or a third hook extending medially from the elongated plate such that the third hook is configured to extend around the scapular triangle when the elongated plate is secured to the scapular spine. and Each of a plurality of fasteners is configured to be secured within one of a plurality of fastening points and secured to the scapula to secure the elongated plate to the scapula.

8. The kit of claim 7 , wherein the at least one hook is modular.

9. 8. The kit of claim 7, wherein the elongated plate is contoured to fit over the scapular spine.

10. 8. The kit of claim 7, wherein the elongated plate is adaptable to allow a user to fit the elongated plate to a portion of a scapula.

11. 8. The kit of claim 7, wherein the elongated plate and the at least one hook are configured to cooperate to apply a compressive force to a fracture along the scapular spine when the elongated plate is secured to the scapular spine.

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