巴西专利BR112014030040B1 reverse shoulder prosthesis

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专利摘要:
Reverse Shoulder Humeral Adaptation Trays. The present invention relates to a reverse shoulder prosthesis that includes a humeral adaptation tray (300) configured to be seated close to a surface extracted from a humerus, wherein the humeral adaptation tray (300) comprises: a cavity ( 302); a central hole; and a distal face (304) including a protrusion (310), the protrusion (310) being: (i) configured as an extension of the distal face, (ii) further offset from the central hole by at least 10 mm, and ( iii) configured to engage a humeral stem; and a humeral liner (250) comprising: a distal rim (252) configured to seat within the cavity (302) of the humeral adapter tray (300); and a concave articulating surface configured to be in correspondence with a convex articulating surface of a glenosphere. Deviating the Reverse Shoulder Humeral Adaptation Tray shifts the humerus in a posterior direction so that it results in better deltoid involvement, more anatomical muscle tension, and greater muscle moment arms during both abduction and internal/external rotation.
公开号:BR112014030040B1
申请号:R112014030040-2
申请日:2013-05-30
公开日:2022-01-25
发明作者:Christopher Roche；Matthew Hamilton；Phong Diep
申请人:Exactech, Inc；
IPC主号:

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RELATED ORDERS
[001] This order claims the benefit and priority for the Order under No U.S. 13/905,599, filed May 30, 2013, Interim Application under U.S. Serial No. 61/653,860, filed May 31, 2012, and Interim Application under U.S. Serial No. 61/779,363, filed March 13, 2013, and all of these applications are incorporated herein by reference to the teachings therein. BACKGROUND
[002] Reverse shoulder was first conceived in the early 1970s to treat patients suffering from rotator cuff tear arthropathy (CTA). The reverse shoulder reverses the anatomical concavities, making the glenoid articular component convex and the humeral articular component concave, creating a fixed fulcrum that prevents the humerus from migrating superiorly. SUMMARY
[003] In accordance with aspects illustrated in the present document, a reverse shoulder prosthesis is described that includes a humeral adaptation tray configured to sit next to a resected surface of a humerus, the humeral adaptation tray comprising: a cavity; a central hole; and a distal face including a ridge, the ridge: (i) configured as an extension of the distal face, (ii) posteriorly offset from the central hole by at least 10 mm, and (iii) configured to engage a humeral stem; and a humeral liner comprising: a distal lip configured to seat within the cavity of the humeral adapter tray; and a concave articulating surface configured to correspond to a convex articulating surface of a glenosphere. In one embodiment, the boss, in addition to being offset posteriorly, is offset superiorly from the central hole by at least 8 mm.
[004] In accordance with aspects illustrated herein, a reverse shoulder prosthesis is described that includes a glenoid plate; a glenosphere; a humeral rod; a humeral fitting tray configured to sit proximate to a resected surface of a humerus, the humeral fitting tray comprising: a cavity; a central hole; and a distal face including a ridge, the ridge: (i) configured as an extension of the distal face, (ii) posteriorly offset from the central hole by at least 10 mm, and (iii) configured to engage a humeral stem; and a humeral liner comprising: a distal lip configured to seat within the cavity of the humeral adapter tray; and a concave articulating surface configured to correspond to a convex articulating surface of a glenosphere. In one embodiment, the boss, in addition to being offset posteriorly, is offset superiorly from the central hole by at least 8 mm.
[005] According to aspects illustrated in the present document, a reverse shoulder prosthesis is described that includes the humeral adaptation tray configured to sit next to a resected surface of a humerus, the humeral adaptation tray comprising: a cavity; a central hole; and a distal face including a ridge, the ridge: (i) configured as an extension of the distal face, (ii) offset superiorly from the central hole by at least 8 mm, and (iii) configured to engage a humeral stem; and a humeral liner comprising: a distal lip configured to seat within the cavity of the humeral adapter tray; and a concave articulating surface configured to correspond to a convex articulating surface of a glenosphere.
[006] In one embodiment, a humeral adaptation tray of the present invention includes a protrusion that is offset posteriorly from the center of the humeral adaptation tray by a distance ranging from at least 10 mm to 25 mm. In one embodiment, the protrusion is posteriorly offset from the center of the humeral fitting tray by a distance ranging from at least 12 mm to 24 mm. In one embodiment, the ridge is posteriorly offset from the center of the humeral fitting tray by a distance ranging from at least 14 mm to 22 mm. In one embodiment, the ridge is posteriorly offset from the center of the humeral fitting tray by a distance ranging from at least 16 mm to 20 mm. In one embodiment, the ridge is offset posteriorly from the center of the humeral fitting tray by 18 mm. In one embodiment, the ridge is offset posteriorly from the center of the humeral fitting tray by 22 mm. In one embodiment, the ridge is offset posteriorly from the center of the humeral fitting tray by 25 mm.
[007] In one embodiment, a humeral adaptation tray of the present invention includes a projection that is offset superiorly from the center of the humeral adaptation tray by a distance ranging from at least 8 mm to 25 mm. In one embodiment, the ridge is offset superiorly from the center of the humeral fitting tray by a distance ranging from at least 9 mm to 24 mm. In one embodiment, the ridge is offset superiorly from the center of the humeral fitting tray by a distance ranging from at least 10 mm to 23 mm. In one embodiment, the ridge is offset superiorly from the center of the humeral fitting tray by a distance ranging from at least 11 mm to 20 mm. In one embodiment, the ridge is offset superiorly from the center of the humeral fitting tray by 8 mm. In one embodiment, the ridge is offset superiorly from the center of the humeral adaptation tray by 10 mm. In one embodiment, the ridge is offset superiorly from the center of the humeral fitting tray by 12 mm.
[008] The boss of a humeral adaptation tray of the present invention can be inserted into a humeral nail and secured to the nail using a torque setting screw, screw, or other gripping device positioned through the boss. . A humeral adaptation tray of the present invention may correspond to the reverse shoulder components and long-stem/revision cemented, primary push fit and primary cemented humeral stems, which include, without limitation, components of the Equinoxe® Reverse Shoulder Assembly.
[009] In one embodiment, a posteriorly/superiorly displaced humeral tray of the present invention shifts the center of rotation posteriorly for better tension and increased rotator moment arms of the remaining rotator cuff muscles to facilitate internal and external rotation.
[0010] In one embodiment, an implanted humeral adaptation tray of the present invention increases the external rotator moment arms of the posterior rotator cuff in order to enhance the function of the external rotators with the reverse shoulder. BRIEF DESCRIPTION OF THE DRAWINGS
[0011] The currently described modalities will be further explained with reference to the attached drawings. The drawings shown are not necessarily to scale, with emphasis generally being placed on illustrating the principles of the currently described modalities.
[0012] Figures 1A, 1B, 1C and 1D show views of the four muscles of the internal rotator of the thorax. Figure 1A shows the latissimus dorsi; Figure 1B shows the teres major; Figure 1C shows the pectoralis major; and Figure 1D shows the subscapularis.
[0013] Figures 2A, 2B and 2C show views of the two muscles of the external rotator of the thorax, the teres minor (Figure 2A) and the infraspinatus (Figure 2B) and the deltoid (Figure 2C).
[0014] Figure 3 shows the components of an Equinoxe® Reverse Shoulder Assembly manufactured by Exactech, Inc., in Gainesville, FL with a "non-shifted" humeral adaptation tray.
[0015] Figures 4A, 4B, 4C and 4D show four views of an embodiment of a posterior deviation humeral adaptation tray of the present invention. The Posterior Displacement Humeral Adaptation Tray can be used instead of the Equinoxe® Reverse Shoulder Assembly's non-deviated Humeral Adaptation Tray shown in Figure 3.
[0016] Figures 5A, 5B and 5C show three views of an embodiment of a humeral liner of the present invention.
[0017] Figures 6A, 6B and 6C show a computer muscle model assembly of the posterior displacement humeral adaptation tray of Figures 4A-D implanted in a humerus when the arm is abducted to about 15° in the scapular plane. As illustrated, the Humeral Adaptation Tray is configured to sit next to a desiccated surface of a humerus.
[0018] Figure 7 shows a longer length computer muscle model mount on the posterior rotator cuff rotator moment arm when the posterior deviation humeral adaptation tray of Figure 4 is implanted in a humerus. As illustrated, the Humeral Adaptation Tray is configured to sit next to (above) a desiccated surface of a humerus.
[0019] Figures 8A, 8B and 8C show a computer muscle model assembly of a non-displaced reverse shoulder humeral adaptation tray implanted in a humerus when the arm is abducted to about 15° in the scapular plane. As illustrated, the Humeral Adaptation Tray is configured to sit next to (above) a desiccated surface of a humerus.
[0020] Figures 9A, 9B and 9C show a computer muscle model montage of the normal shoulder when the arm is abducted to about 15° in the scapular plane.
[0021] Figures 10A and 10B show two views of an embodiment of a posterior/superior deviation humeral adaptation tray of the present invention. The Posterior/Superior Displacement Humeral Adaptation Tray can be used in place of the Equinoxe® Reverse Shoulder Assembly's non-deviated Humeral Adaptation Tray shown in Figure 3.
[0022] Figures 11A and 11B show a reverse shoulder assembly of the present invention. The Posterior/Superior Deviation Humeral Adaptation Tray of Figures 10A and 10B is being used with several other components of the Equinoxe® Reverse Shoulder Assembly shown in Figure 3 (the Posterior/Superior Deviation Humeral Adaptation Tray is used in place of the undeviated humeral).
[0023] Figure 12 shows a top-bottom view of the reverse shoulder mount of Figure 11 in a computer muscle model. Note the most posteriorly displaced position of the humeral tuberosities. As illustrated, the Humeral Adaptation Tray is configured to sit next to (above) a desiccated surface of a humerus.
[0024] Figures 13A and 13B show a computer model of 8 muscles simulated as 3 lines from origin to insertion, anterior (left) and posterior (right) views of the normal shoulder in 25° abduction in the scapular plane.
[0025] Figures 14A and 14B show a computer model that simulates the abduction of the reverse shoulder mount of Figures 11A and 11B (0° of inclination, 20° of humeral retroversion) from 0 to 80° in the scapular plane relative to to the fixed scapula. As illustrated, the Humeral Adaptation Tray is configured to sit next to (above) a desiccated surface of a humerus.
[0026] Figures 15A and 15B show a computer model that simulates the internal (left) and external (right) rotation of the reverse shoulder assembly of Figures 11A and 11B at 40° to the fixed scapula. As illustrated, the Humeral Adaptation Tray is configured to sit next to (above) a desiccated surface of a humerus.
[0027] Figures 16A, 16B and 16C are images showing how the external rotation moment arms of the posterior rotator cuff muscles (e.g., infraspinatus and teres minor) change between an anatomical shoulder, a reverse shoulder mount Equinoxe® standard (with a non-displaced humeral adaptation tray), and the reverse shoulder mount of Figures 11A and 11B (with a posterior/superior deviation humeral adaptation tray). As illustrated, the Humeral Adaptation Tray is configured to sit next to (above) a desiccated surface of a humerus.
[0028] Figures 17A, 17B and 17C show a comparison of the standard and posterior/superior deviation reverse shoulder moment arms: 0 to 140° abduction of the anterior deltoid adductor moment arms (Figure 17A), intermediate ( Figure 17B), and posterior (Figure 17C) (y axis) in the scapular plane (x axis).
[0029] Figures 18A, 18B and 18C show a comparison of the standard and posterior/superior deviation reverse shoulder moment arms: 0 to 140° abduction of the subscapularis adductor moment arms (Figure 18A), teres major ( Figure 18A), and the pectoralis major (Figure 18C) (y axis) in the scapular plane (x axis).
[0030] Figures 19A and 19B show a comparison of the standard and posterior/superior deviation reverse shoulder moment arms: 0 to 140° abduction of the infraspinatus adductor moment arms (Figure 19A) and teres minor (Figure 19B) (geometric y axis) in the scapular plane (geometric x axis).
[0031] Figures 20A, 20B and 20C show a comparison of the standard and posterior/superior deviation reverse shoulder moment arms: abduction of the anterior deltoid rotator moment arms (Figure 20A), intermediate (Figure 20), and (Figure 20C) (y-axis) from -30 (IR) to 60° (ER) with the arm at 30° (x-axis).
[0032] Figures 21A, 21B and 21C show a comparison of the standard and posterior/superior deviation reverse shoulder moment arms: abduction of the subscapularis rotator moment arms (Figure 21A), teres major (Figure 21B), and of the pectoralis major (Figure 21C) (y-axis) from -30 (IR) to 60° (ER) with the arm at 30° (x-axis).
[0033] Figures 22A and 22B show a comparison of the standard and posterior/superior deviation reverse shoulder moment arms: abduction of the infraspinatus rotator moment arms (Figure 22A) and teres minor (Figure 22B) (geometric axis y) from -30 (IR) to 60° (ER) with the arm in abduction of 30° (geometric axis x).
[0034] Although the designs identified above present modalities currently described, other modalities are also contemplated, as noted in the discussion. This description presents illustrative modalities by way of representation and not limitation. Various other modifications and modalities may be devised by those skilled in the art, which are encompassed in the scope and spirit of the principles of the modalities currently described. DETAILED DESCRIPTION
[0035] Detailed embodiments of the present invention are described herein; however, it should be understood that the described embodiments are merely illustrative of the invention, which may be embodied in various forms. Furthermore, each of the examples given in connection with the various embodiments of the invention are intended to be illustrative, not restrictive. Additionally, figures are not necessarily to scale, some features may be exaggerated to show details of particular components. Therefore, specific functional and structural details described herein are not to be construed as limiting, but merely as a representative basis for teaching a person skilled in the art to variously employ the present invention.
[0036] As used herein, the term "deltoid wrap" refers to a measurement of the wrap of the deltoid around the greater tuberosity of the humerus, the angle defines the amount of abduction in the humeral plane required before the deltoid stops wrapping. the greater tuberosity.
[0037] As used herein, the "muscle tension" of each muscle is measured as a comparison of muscle length for each joint configuration through a given type of movement versus muscle length for a normal shoulder through of the same type of movement.
[0038] Muscles generate forces in a straight line that are converted into torque in proportion to the perpendicular distance between the joint center of rotation and the muscle's line of action. As used herein, this perpendicular distance is referred to as the "muscle moment arm".
[0039] Loss of external rotation (and excess internal rotation) impairs a patient's ability to maintain their arm in neutral rotation as the arm is elevated (eg, positive horn blast signal), preventing various everyday activities that include : handshake, drinking/eating, and washing hair. The origin of the latissimus dorsi muscle, illustrated in Figure 1A, is the rib cage and its insertion is in the anterior humerus below the surgical neck. The origin of the teres major, illustrated in Figure 1B, is the posterior scapula and its insertion is in the anterior humerus below the surgical neck. The origin of the pectoralis major, illustrated in Figure 1C, is in the rib cage and middle clavicle and its insertion is in the anterior humerus below the surgical neck. The origin of the subscapularis, illustrated in Figure 1D, is on the anterior scapula and its insertion on the lesser tuberosity.
[0040] Muscle transfers are often recommended for reverse shoulder patients with external rotation deficiency because the posterior deltoid alone is insufficient to restore active external rotation even with lateralized reverse shoulder designs. In general, internally rotating muscles (eg, muscles that attach to the anterior side of the humerus) are transferred through the joint center to the posterior side of the humerus where their contraction now causes external rotation. The latissimus dorsi is the most common muscle transferred in reverse shoulder arthroplasty, it is removed from the anterior axis of the humerus and reattached to the greater tuberosity. Another common muscle transfer is a modification of the L'Episcopo method, in which both the latissimus dorsi and teres major are transferred to the greater tuberosity. Although muscle transfers have been shown to successfully restore active external rotation, they should not be performed if the teres minor is functional. Additionally, it should be recognized that these procedures limit active internal rotation and further alter the relationship of each shoulder muscle to its normal physiological function.
[0041] Figures 2A to 2C show views of the two muscles of the external rotator of the thorax, the teres minor (Figure 2A) and the infraspinatus (Figure 2B) and the deltoid, Figure 2C. The origin of the teres minor, illustrated in Figure 2A, is on the lateral margin of the scapula and its insertion is on the lower portion of the greater tuberosity. The origin of the infraspinatus, illustrated in Figure 2B, is in the posterior scapula and its insertion is in the superior portion of the greater tuberosity.
[0042] Figure 3 shows components of the Equinoxe® 100 standard reverse shoulder mount manufactured by Exactech, Inc., in Gainesville, FL. The Equinoxe® 100 Standard Reverse Shoulder Assembly includes (a) a bone cage that can enhance glenoid fixation and allow "full growth" of bones using conductive/inductive bone grafts; (b) an inferiorly displaced glenoid plate that can allow attachment to occur at the center of the glenoid while also securing the protruding inferior glenoid, thereby eliminating/minimizing scapular erosion; (c) a glenosphere (in one embodiment, a beveled glenosphere) that can aid in glenosphere insertion and protect any intact soft tissue; (d) an extended glenosphere articular surface can enhance range of motion and maximize the protruding inferior glenosphere to minimize the potential for scapular erosion; (e) multiple humeral pads (standard and restricted), humeral fitting tray (with centered, ie, non-displaced, protrusion) and glenosphere options that provide intraoperative flexibility; (f) anti-rotation features in humeral liners improve implant stability and connection; (g) Platform Humeral Nail facilitates revision of an Equinoxe® primary humeral nail to a reverse. Caps lock compression screws to the glenoid plate at a variable angle (not shown); (h) backward curved glenosphere/glenoid plate can conserve bone and convert shear forces into compressive forces; (i) variable-angle compression screws can compress the glenoid plate to the bone while providing 30 degrees of angular variability; and (j) an anatomically shaped glenoid plate can provide multiple options for screw insertion, which is particularly important when revising a nailed and/or striated glenoid for a reverse. The torque defining the screw locks the humeral adaptation tray at 11 N*m (not shown).
[0043] Figures 4A-4D show an embodiment of a posterior deviation humeral adaptation tray 200 of the present invention. Humeral fitting tray 200 includes a cavity 202 that is non-circular in shape and configured to accept a humeral liner to result in rotational stability. Humeral adapter tray 200 includes a distal face 204 that has a protrusion 210 that is configured as an extension of the distal face. The projection 210 is a button, pin or other protrusion or extension. The projection 210 is posteriorly offset from the center of the humeral adaptation tray 200 by at least 10 mm. In one embodiment, the projection 210 is offset posteriorly from the center of the humeral adaptation tray 200 by at least 10 mm. In one embodiment, the protrusion 210 is posteriorly offset from the center of the humeral adaptation tray 200 by a distance ranging from 11 mm to 25 mm. In one embodiment, the protrusion 210 is offset posteriorly from the center of the humeral adaptation tray 200 by a distance ranging from 12 mm to 24 mm. In one embodiment, the protrusion 210 is offset posteriorly from the center of the humeral adaptation tray 200 by a distance ranging from 14 mm to 22 mm. In one embodiment, the projection 210 is posteriorly offset from the center of the humeral adaptation tray 200 by a distance ranging from 16 mm to 20 mm. In one embodiment, the projection 210 is offset posteriorly from the center of the humeral adaptation tray 200 by 18 mm. In one embodiment, the projection 210 is offset posteriorly from the center of the humeral adaptation tray 200 by 22 mm. In one embodiment, the projection 210 is offset posteriorly from the center of the humeral adaptation tray 200 by 25 mm. In one embodiment, the posterior deviation humeral adaptation tray 200 is constructed from titanium. In one embodiment, the Humeral Adaptation Tray 200 is machined from forged Ti-6Al-4V. In one embodiment, the humeral adaptation tray 200 features a dual locking mechanism comprising a female locking mushroom 224 and a lateral male dovetail feature 226. In one embodiment, the humeral adaptation tray 200 has an anti-rotation feature 228 The anti-rotation feature 228 is an asymmetrically shaped female angled surface over the humeral adaptation tray 200 - intended to prevent rotational movement between the humeral pad 250 and the humeral tray 200. In one embodiment, the humeral adaptation tray 200 has both a double locking mechanism and an anti-rotation feature.
[0044] Figures 5A, 5B and 5C show three views of one embodiment of a humeral liner 250 of the present invention. The humeral liner 250 is a concave component that corresponds to a convex glenosphere. Humeral liner 250 includes a distal lip 252 that is configured for placement within cavity 202 of humeral adapter tray 200 to result in rotational stability. In one embodiment, the distal rim 252 has a non-circular shape configured to match the non-circular shape of the cavity 202 of the humeral adapter tray 200. In one embodiment, the humeral liner 250 features a dual locking mechanism comprising a locking mushroom. male 254 and a lateral female dovetail feature 256. In one embodiment, the humeral liner 250 has an anti-rotation base 258. The anti-rotation feature 258 is an asymmetrically shaped male angled surface over the humeral liner 250 - intended to prevent rotational movement between the humeral liner 250 and the humeral tray 200. In one embodiment, the humeral liner 250 features both a double locking mechanism and an anti-rotation base. In one embodiment, the humeral liner 250 is used from compression molded UHMWPE.
[0045] The Posterior Deviation Humeral Adaptation Tray 200 can be attached to a humeral nail, e.g. an Equinoxe® Humeral Nail, with the use of a torque setting screw that secures the Humeral Adaptation Tray 200 to the humeral nail . The torque setting screw is positioned through the boss 210 over the cavity side 202 of the humeral adaptation tray 200. A humeral liner 250, for example an Equinoxe® humeral liner, is secured to the posterior deviation humeral adaptation tray by middle of central hole 220. Holes 230 in humeral adapter tray 200 attach to an instrument for providing torque. The posterior deviation humeral adapter tray 200 posteriorly displaces the projection 210 to increase the external rotation moment arms of the posterior rotator cuff. Increasing the external rotation moment arms of the posterior rotator cuff has the potential to improve function for patients with functioning but weak external rotators (e.g., patients with a nonfunctional infraspinatus but a functional teres minor), which is common in patients with rotator cuff tear arthropathy.
[0046] A computer muscle model was conducted to evaluate the effect of the Posterior Displacement Humeral Adaptation Tray 200 of the present invention (as part of an Equinoxe® Reverse Shoulder Mount) on muscle lengthening/shortening, deltoid, and anterior and posterior rotator cuff moment arms as the posterior deviation humeral adaptation tray was abducted in the scapular plane (relative to a non-deviated reverse shoulder humeral adaptation tray of the standard Equinoxe® reverse shoulder mount). Five muscles were simulated in this analysis: middle deltoid, posterior deltoid, subscapularis, infraspinatus, and teres minor; the center of each muscle attachment on the humerus and scapula was digitized on each bone model and a line was drawn to connect each point to simulate each muscle. After mounting, each mount was abducted in the scapular plane and evaluated relative to a normal shoulder by quantifying each muscle adductor moment arm, each muscle length, and each muscle line of action. Muscle lengths were measured directly in Unigraphics. Adductor moment arms were calculated using Matlab (Mathworks, Inc.) In Matlab, the scapula was rotated in the scapular plane 1° for every 1.8° of humeral movement in the scapular plane.
[0047] As described in Table 1, the computer model demonstrated that a posteriorly displaced humeral adaptation tray of the present invention (Figures 6A-6C and Figure 7), which has a protrusion that is posteriorly displaced by 10 mm, best restored the anatomical tension of the infraspinatus (from -2.2% to 1.2% of the normal muscle length) and teres minor (from -5.9% to -0.9% of the normal muscle length) in relation to a tray non-displaced humeral fitting (Figures 8A-8C) when mounted to the 38 mm Equinoxe® Reverse Shoulder. Note that Figures 6A-6C and Figure 7 depict the deflected humeral adaptation tray as it is abducted by approximately 15° in the scapular plane, and Figures 8A-8C depict an undeviated humeral adaptation tray as it is abducted by about 15° in the scapular plane. For comparative purposes, Figures 9A-9C depict a normal shoulder abducted by about 15° in the scapular plane. As described in Table 2, the posterior deviation humeral adaptation tray of the present invention, which has a ridge that is posteriorly displaced by 10 mm, increased the external rotator moment arms of the posterior deltoid by 2%, the infraspinatus by 45% , and teres minor by 18% compared to increases associated with a non-displaced humeral adaptation tray relative to a normal shoulder. Table 1. Posterior and Anterior Rotator Cuff Muscle Stretch Relative to a Normal Shoulder as the Humerus is Elevated in the Scapular Plane from 0 to 60 degrees (relative to a fixed scapula)
Table 2. Middle Rotator Moment Arm Length Relative to a Normal Shoulder to Vary the Reverse Shoulder as the Humerus is Elevated in the Scapular Plane from 0 to 60 degrees (relative to a fixed scapula)

[0048] In one embodiment, a reverse shoulder humeral tray of the present disclosure is used in a reverse shoulder prosthesis which may include at least some of the following components, a humeral stem (which may be used in snap fit and/or cemented and can be constructed from titanium), a humeral liner (a concave component that corresponds to a convex glenosphere; can be constructed from UHMWPE), a glenosphere (can be constructed from cobalt-chromium), a (can be constructed from titanium), a locking plate (can be constructed from titanium) and a glenoid plate (can be constructed from titanium), and various screws and fixtures for mounting individual components to each other and for mounting the construct to native bone (all can be constructed from titanium).
[0049] Figures 10A and 10B show an embodiment of a superior posterior offset humeral adaptation tray 300 of the present invention. Humeral fitting tray 300 includes a cavity 302 that is non-circular in shape and configured to accept a humeral liner so as to result in rotational stability. Humeral adapter tray 300 includes a distal face 304 that has a protrusion 310 that is configured as an extension of the distal face. Protrusion 310 is a button, pin, or other bulge or extension. In one embodiment, the projection 310 is further offset from the center of the humeral adaptation tray 300 by at least 10 mm. In one embodiment, the projection 310 is posteriorly offset from the center of the humeral adaptation tray 300 by about 11 mm to about 25 mm. In one embodiment, the projection 310 is posteriorly offset from the center of the humeral adaptation tray 300 by about 12 mm to about 24 mm. In one embodiment, the projection 310 is posteriorly offset from the center of the humeral adaptation tray 300 by about 14 mm to about 22 mm. In one embodiment, the projection 310 is posteriorly offset from the center of the humeral adaptation tray 300 by about 16 mm to about 20 mm. In one embodiment, the projection 310 is posteriorly offset from the center of the humeral adaptation tray 300 by about 18 mm. In one embodiment, the projection 310 is posteriorly offset from the center of the humeral adaptation tray 300 by about 22 mm. In one embodiment, the projection 310 is posteriorly offset from the center of the humeral adaptation tray 300 by about 25 mm. In one embodiment, the projection 310 is offset superiorly from the center of the humeral adaptation tray 300 by at least 8 mm. In one embodiment, the ridge is offset superiorly from the center of the humeral adaptation tray 300 by a distance in the range of at least 8 mm to 25 mm. In one embodiment, the ridge is offset superiorly from the center of the humeral adaptation tray 300 by a distance in the range of at least 9 mm to 24 mm. In one embodiment, the ridge is offset superiorly from the center of the humeral adaptation tray 300 by a distance in the range of at least 10 mm to 23 mm. In one embodiment, the ridge is offset superiorly from the center of the humeral adaptation tray 300 by a distance in the range of at least 11 mm to 20 mm. In one embodiment, the ridge is offset superiorly from the center of the humeral adaptation tray 300 by 8 mm. In one embodiment, the ridge is offset superiorly from the center of the humeral adaptation tray 300 by 10 mm. In one embodiment, the ridge is offset superiorly from the center of the humeral adaptation tray 300 by 12 mm.
[0050] As illustrated in Figures 11A and 11B, the Posterior/Superior Deviation Humeral Adaptation Tray 300 can be attached to a Humeral Stem 400 of an Equinoxe® Reverse Shoulder Mount using a torque setting screw positioned through the of boss 310. A glenosphere 500 of the Equinoxe® reverse shoulder assembly is also illustrated. A humeral liner 250, for example an Equinoxe® Humeral Liner, is attached to the posterior deviation humeral adapter tray through the center hole. The holes in the Humeral Adaptation Tray 300 attach to an instrument to deliver the torque. Posteriorly offset humeral adapter tray 300 posteriorly displaces protrusion 310 to increase the external rotational moment arms of the posterior rotator cuff. Increasing the external rotation moment arms of the posterior rotator cuff has the potential to improve function for patients with functioning but weak external rotators (eg, patients with a nonfunctional infraspinatus but a functional teres minor) , which is common in patients with rotator cuff tear arthropathy.
[0051] In one embodiment, the humeral fitting tray 300 is constructed from titanium. In one embodiment, the Humeral Adaptation Tray 300 is machined from forged Ti-6Al-4V. In one embodiment, the humeral adaptation tray 300 features a dual locking mechanism comprising a female locking mushroom 324 and a lateral male dovetail feature 326. In one embodiment, the humeral adaptation tray 300 has an anti-rotation feature 328 The anti-rotation feature 328 is an asymmetrically shaped female angled surface over the humeral adaptation tray 300 - intended to prevent rotational movement between the humeral pad 250 and the humeral tray 300. In one embodiment, the humeral adaptation tray 300 has both a dual locking mechanism and an anti-rotation feature.
[0052] The 300 Posterior/Superior Deviation Humeral Adaptation Tray performs posterior translation of the humeral head and tuberosities posteriorly (Figure 12) to better tension the posterior rotator cuff muscles and increase your external force arm (to enhance torque capacity) and superiorly translates the humeral head and tubercles to reduce deltoid overtension (as with reverse shoulder arthroplasty).
[0053] A standard 38 mm Equinoxe® reverse shoulder mount (which has the undisplaced humeral adaptation tray) and a 38 mm Equinoxe® offset reverse shoulder mount (which has a boss that is later offset by 11 mm and superiorly offset by 9 mm) were geometrically modeled and implanted in a 3-D digitized scapula and humerus; a 3-D digital clavicle and ribcage were also included (Pacific Research Laboratories, Inc; Vashon Island, WA). The digital humerus and scapula were mounted to simulate a normal shoulder, which functions as the control in such an analysis; the humeral head was centered on the glenoid and deviated by 4 mm from the center of the glenoid to consider the thickness of the cartilage and labrum. Eight muscles were simulated according to 3 lines from their origin on the scapula or clavicle to their insertion on the humerus: anterior deltoid, middle deltoid, posterior deltoid, subscapularis, infraspinatus, teres major, teres minor and the clavicular portion of the pectoralis major (Figure 13A and Figure 13B).
[0054] To characterize the biochemical impact of the Equinoxe® deviated 38mm reverse shoulder mount (which has a ridge that is posteriorly displaced by 11mm and superiorly displaced by 9mm) on each muscle, each device was implanted identically into the glenoid such that the glenoid baseplate aligns with the lower glenoid ridge as the humeral component was successively oriented at 20° of retroversion. After assembly, 2 movements were simulated: 1) abduction (Figure 14A and Figure 14B) and 2) internal/external rotation (Figure 15A and Figure 15B). To simulate abduction, the humeral component was abducted from 0 to 80° in the scapular plane in relation to a fixed scapula. To simulate internal/external rotation, the humeral component was rotated 40° internally and 40° externally with the arm at 0° of abduction.
[0055] For each simulated movement, muscle lengths were measured as the average length of the 3 lines representing the muscle at each degree of movement; each average muscle length, at each degree of movement, was compared as a percentage of the corresponding normal shoulder muscle length. For clarity, a positive percentage indicates the muscle's stretch relative to the normal shoulder; while, a negative percentage indicates the shortening of the muscle in relation to the normal shoulder. The abduction angle at which the middle deltoid stops wrapping around the greater tuberosity has also been quantified as a measure of stability (e.g., less deltoid involvement implies reduced humeral head compression into the glenoid) for the normal shoulder. and Equinoxe® standard and deviated reverse shoulders. The arms were calculated using a custom code in Matlab (Mathworks, Inc.). The abduction moment arms were calculated for each muscle in abduction from 0 to 140° (it should be noted that in Matlab, the scapula was rotated in the scapular plane 1° for every 1.8° of humeral movement in the scapular plane; while , in Unigraphics the scapula remained fixed). The rotational moment arms were calculated for each muscle from -30° (IR) to 60° (ER) with the arm at 30° of abduction.
[0056] As described in Table 3, both reverse shoulders of the Equinoxe®, regardless of the deviation or position of the humeral tray, displaced the center of rotation (CoR) medially and inferiorly in relation to the normal shoulder. For the standard (non-displaced humeral tray), such displacement in the CoR caused a medial and inferior displacement of the humerus and a decrease in the angle of involvement of the middle deltoid relative to the normal shoulder, see Table 4. For the displaced humeral tray, the humerus was displaced superiorly and posteriorly in relation to the undisplaced humeral tray, see Tables 3 and 4. Table 3. Change in Center of Rotation for Each Reverse Shoulder Relative to the Normal Shoulder
Table 4. Medial/Lateral Position of the Humerus and Its Impact on Deltoid Involvement

[0057] As described in Tables 5 to 7, for each simulated movement, both Equinoxe® reverse shoulders lengthened each deltoid head, shortened the internal rotators (subscapularis and teres major, with the exception of the pectoralis major which was lengthened) and shortened the external rotators (infraspinatus and teres minor) in relation to the normal shoulder. As described in Table 5, in abduction, the Equinoxe® Posterior/Superior Displacement Humeral Tray Reverse Shoulder design overstressed the three deltoid heads less, tensioned the pectoralis more, and better restored anatomical tension to the subscapularis, infraspinatus, teres major and smaller round than the Equinoxe® standard (non-deviated) humeral tray reverse shoulder design. Similar trends were observed during internal and external rotation, see Tables 6 and 7. Table 5. Average Muscle Length Relative to Normal Shoulder as Each Reverse Shoulder is Abducted in the Scapular Plane from 0 to 65°. It is observed that the deflected humeral tray collided superiorly at 65°, therefore, the analysis range was reduced from 0 to 80°.
Table 6. Average Muscle Length Relative to Normal Shoulder as Each Reverse Shoulder is Internally Rotated from 0 to 40° with arm at 0° of abduction.
Table 7. Average Muscle Length Relative to Normal Shoulder as Each Reverse Shoulder is Externally Rotated from 0° to 40° with the arm at 0° of abduction.

[0058] Figures 16A, 16B and 16C are images showing how the external rotation moment arms of the posterior rotator cuff muscles (e.g. infraspinatus and teres minor) are changed between an anatomical shoulder, a standard reverse shoulder and the posterior/superior offset reverse shoulder of the present invention.
[0059] The abduction moment arms of the 3 deltoid heads: anterior (Figure 17A), middle (Figure 17B) and posterior (Figure 17C); the internal rotators: subscapularis (Figure 18A), teres major (Figure 18A) and pectoralis major (Figure 18C); and the external rotators: infraspinatus (Figure 19A) and teres minor (Figure 19B) during abduction in the scapular plane from 0 to 140° (with scapular movement of 1° for every 1.8° of humeral movement) are presented. ent below. As illustrated in Figures 17A, 17B and 17C, the standard and posterior/superior deviation humeral trays are associated with similar abduction moment arms each of the three deltoid heads during abduction in the scapular plane. As illustrated in Figures 18A, 18B and 18C, the humeral tray of posterior/superior deviation is associated with a slightly greater abduction moment arm for the internal rotator muscles: ~5 mm greater for both the subscapularis and teres major and ~2.5 mm greater for the pectoralis major, relative to the standard (non-displaced) humeral tray during abduction in the scapular plane. As illustrated in Figures 19A and 19B, the posterior/superior humeral displacement tray is associated with a slightly greater abduction moment arm for the external rotator muscles: ~5 mm greater for both the infraspinatus and teres minor, relative to the standard humeral tray (not deviated) during abduction in the scapular plane. As described in Figures 18A to 18C and Figures 19A to 19B, due to the fact that the posterior/superior displacement humeral tray displaces the humerus superiorly relative to the non-displaced tray, each anterior/posterior shoulder muscle in Figures 18A to 18C and Figures 19A to 19B converts from an adductor to abductor early in abduction (eg, crosses 0 mm), where the subscapularis converts at 62°, the infraspinatus converts at 43°, and the teres minor converts at 110°. For the posterior/superior humeral deviation tray, causing each muscle to convert from adductors to abductors at an early time potentially results in improved abduction capacity by limiting the antagonistic behavior of each muscle with the deltoid, thus reducing the deltoid force needed to lift the arm.
[0060] The internal/external rotator moment arms of the 3 deltoid heads: anterior (Figure 20A), middle (Figure 20) and posterior (Figure 20C); the internal rotators: subscapularis (Figure 18A), teres major (Figure 18A) and pectoralis major (Figure 18C); and the external rotators: infraspinatus (Figure 19A) and teres minor (Figure 19B) during internal rotation, from 30 to 0° and external rotation from 0 to 60° with the arm in 30° of abduction are shown below. As depicted in Figures 20A to 20C, the standard (non-displaced) humeral tray is associated with a slightly larger anterior deltoid rotation moment arm (~4 mm) during internal rotation and early in external rotation. Similarly, the standard (non-displaced) humeral tray is also associated with a slightly larger (~2 mm) mid-deltoid rotation moment arm during internal rotation relative to the deviated humeral tray during IR/ER rotation. On the other hand, the posterior/superior deviated humeral tray is associated with a slightly larger (~3 mm) posterior deltoid rotation moment arm during internal rotation and earlier in external rotation relative to the standard (non-displaced) humeral tray. during IR/ER rotation. As depicted in Figures 21A to 21C, the posterior/superior displacement humeral tray is associated with a slightly larger (~5 mm) subscapularis and teres major rotator moment arm during external and internal rotation. Similarly, the posterior/superior deviation humeral tray is associated with a slightly larger (~4mm) pectoralis major rotator moment arm during external rotation relative to the standard (non-deviated) humeral tray during IR/ER rotation. On the other hand, during internal rotation, the standard (non-displaced) humeral tray is associated with a slightly larger (~4mm) pectoralis major rotator moment arm during internal rotation relative to the deviated humeral tray during IR/ ER As depicted in Figures 22A and 22B, the posterior/superior humeral deviation tray 300 is associated with a greater abduction moment arm for the external rotator muscles: ~5 mm greater for both the infraspinatus and teres minor during internal rotation and ~10 mm greater for both the infraspinatus and teres minor during external rotation than the standard (non-displaced) humeral tray during external and internal rotation. Figures 22A and 22B illustrate that the moment arms of both external rotator muscles are substantially increased throughout the range of motion, see Tables 8 and 9. As described in Tables 8 and 9, the posterior/superior deviation tray results in a 44% greater external rotation moment arm for the infraspinatus over standard deviation humeral tray (28.3 mm vs. 19.6 mm) when the arm is rotated through 30 of internal rotation ("IR") at 60 degrees of external rotation ("ER"). Similarly, the posterior/superior deviation tray results in a 35% greater external rotation moment arm for the teres minor compared to the standard deviation humeral tray (30.1 mm vs. 22.3 mm) when the arm is rotated from 30 degrees of internal rotation to 60 degrees of external rotation. Due to the fact that the posterior/superior deviation tray displaces the humerus posteriorly, the internal rotation capacity of the subscapularis and teres major is decreased by 7.1 mm and 9.5 mm, respectively, while the external rotation capacity of the infraspinatus and teres minor is increased by 8.6 mm and 7.8 mm, respectively. In rotation, the displaced humeral tray makes the posterior shoulder muscles more effective external rotators. Improved external rotation capability is important for patients with external rotation deficiency; Due to the fact that external rotation is necessary for many activities of daily living, increasing the rotator moment arm lengths of the only two external rotators is advantageous for restoring function. Table 8. Undisplaced reversed shoulder rotation moment arms when humerus is abducted to 30° and rotated from 30° of IR to 60° of ER
Table 9. Displaced reverse shoulder rotation moment arms (mm) when humerus is abducted to 30° and rotated from 30° of IR to 60° of ER

[0061] Reversing the anatomical concavities with reverse shoulder arthroplasty fundamentally alters the position of the CoR relative to the normal shoulder and causes a shift in the position of the humerus, which has implications for deltoid involvement, muscle tension, and muscle moment arms. Deviating the Reverse Shoulder Humeral Adaptation Tray displaces the humerus in the posterior/superior direction so that results in better deltoid involvement, more anatomical muscle tension, and greater muscle moment arms during both abduction and internal/external rotation . Specifically, with the posterior/superior deviation humeral adaptation tray, the angle of mid deltoid involvement was increased, the three deltoid heads could be less overstressed, the pectorals were more tensioned, and the tension of the subscapularis, infraspinatus, teres major, and teres minor was restored more closely to its anatomical tension than the standard (non-deviated) Equinoxe® Humeral Fitting Tray. Additionally, with the posterior/superior deviation humeral adaptation tray, the abduction moment arms of the internal and external rotators were increased during abduction and the rotator moment arms of the posterior deltoid, subscapularis, teres major, teres minor, and infraspinatus were increased during external and internal rotation.
[0062] While various embodiments of the present invention have been described, it is understood that such embodiments are illustrative only and not restrictive, and that many modifications may become apparent to those of ordinary skill in the art. For example, any element described in this document can be provided in any desired size (for example, any element described in this document can be provided in any custom size or any element described in this document can be provided in any desired size selected from a "family" of sizes, such as small, medium, large). In addition, one or more of the components may be produced from any of the following materials: (a) any biocompatible material (biocompatible material, which can be treated to allow surface bone ingrowth or to prohibit bone ingrowth surface - depending on the surgeon's wishes); (b) a plastic; (c) a fiber; (d) a polymer; (e) a metal (a pure metal such as titanium and/or an alloy such as Ti--Al--Nb, Ti-6Al-4V, stainless steel); (f) any combination thereof. Also, the metal construct can be a machined metal construct. Furthermore, the prosthesis may utilize one or more modular elements.
[0063] All patents, patent applications and published references mentioned herein are hereby incorporated in their entirety by way of reference. It will be apparent that several of the above descriptions and other features and functions or alternatives thereof may desirably be combined to form several other different systems or applications. Various alternatives, modifications, variations or improvements to the description not currently foreseen or anticipated may subsequently be made by those skilled in the art, such alternatives, modifications or improvements are also intended to be encompassed by the following claims.

权利要求:
Claims (20)
[0001]
1. Reverse shoulder prosthesis, characterized in that it comprises: a humeral adaptation tray (300) configured to be seated next to a surface extracted from a humerus, and the humeral adaptation tray (300) comprises: a cavity ( 202, 302); a central hole (220); and a distal face including a protrusion (210, 310), wherein the protrusion (210, 310) is: (i) configured as an extension of the distal face, (ii) further offset from the central hole (220) by at least 10 mm, and (iii) configured to engage a humeral stem (400); and a humeral liner (250) comprising: a distal lip (252) configured to seat within the cavity (202, 302) of the humeral adapter tray (300); and a concave hinge surface configured to be in correspondence with a convex hinge surface of a glenosphere (500).
[0002]
2. Reverse shoulder prosthesis, according to claim 1, characterized in that the posteriorly deflected protrusion (210, 310) is configured to posteriorly displace a humerus position to: (i) increase an angle of involvement of a deltoid muscle of a shoulder so that it results in joint stability, (ii) tensing muscles in a shoulder so that it results in joint stability and improved muscle function, and (iii) increasing the internal rotator momentum arms and outside of a shoulder so that it results in improved muscle function.
[0003]
3. Reverse shoulder prosthesis, according to claim 1, characterized in that the humeral adaptation tray (300) includes an anti-rotation feature (228, 328).
[0004]
4. Reverse shoulder prosthesis according to claim 1, characterized in that the humeral liner (250) includes an anti-rotation feature (228, 328).
[0005]
5. Reverse shoulder prosthesis, according to claim 1, characterized in that the humeral adaptation tray (300) has a double locking mechanism.
[0006]
6. Reverse shoulder prosthesis, according to claim 1, characterized in that the humeral lining (250) has a double locking mechanism.
[0007]
7. Reverse shoulder prosthesis, according to claim 1, characterized in that the protrusion (210, 310) is subsequently deviated from the central hole (220) by a distance in the range of at least 10 mm to 25 mm.
[0008]
8. Reverse shoulder prosthesis, according to claim 1, characterized in that the protrusion (210, 310), in addition to being later deviated, is superiorly deviated from the central hole (220) by at least 8 mm.
[0009]
9. Reverse shoulder prosthesis, according to claim 8, characterized in that the protrusion (210, 310) is superiorly deviated from the central hole (220) by a distance in the range of at least 8 mm to 25 mm.
[0010]
10. Reverse shoulder prosthesis, characterized in that it comprises: a glenoid plate; a glenosphere (500); a humeral stem (400); a humeral adaptation tray (300) configured to be seated proximate to a surface extracted from a humerus, the humeral adaptation tray (300) comprising: a cavity (202, 302); a central hole (220); and a distal face including a protrusion (210, 310), wherein the protrusion (210, 310) is: (i) configured as an extension of the distal face, (ii) further offset from the central hole (220) by at least 10 mm, and (iii) configured to engage a humeral stem (400); and a humeral liner (250) comprising: a distal lip (252) configured to seat within the cavity (202, 302) of the humeral adapter tray (300); and a concave hinge surface configured to be in correspondence with a convex hinge surface of a glenosphere (500).
[0011]
11. Reverse shoulder prosthesis, according to claim 10, characterized in that the posteriorly deviated protrusion (210, 310) is configured to posteriorly displace a position of the humerus to: (i) increase an angle of involvement of a muscle deltoid of one shoulder so that it results in united stability, (ii) tense muscles of one shoulder so that it results in united stability and improved muscle function, and (iii) increasing the internal and external rotator momentum arms of a shoulder so that it results in improved muscle function.
[0012]
12. Reverse shoulder prosthesis, according to claim 10, characterized in that the humeral adaptation tray (300) includes an anti-rotation feature (228, 328).
[0013]
13. Reverse shoulder prosthesis according to claim 10, characterized in that the humeral liner (250) includes an anti-rotation feature (228, 328).
[0014]
14. Reverse shoulder prosthesis, according to claim 10, characterized in that the humeral adaptation tray (300) has a double locking mechanism.
[0015]
15. Reverse shoulder prosthesis, according to claim 10, characterized in that the humeral lining (250) has a double locking mechanism.
[0016]
16. Reverse shoulder prosthesis, according to claim 10, characterized in that the protrusion (210, 310) is subsequently deviated from the central hole (220) by a distance in the range of at least 10 mm to 25 mm.
[0017]
17. Reverse shoulder prosthesis, according to claim 10, characterized in that the protrusion (210, 310), in addition to being later deviated, is superiorly deviated from the central hole (220) by at least 8 mm.
[0018]
18. Reverse shoulder prosthesis, according to claim 17, characterized in that the protrusion (210, 310) is superiorly deviated from the central hole (220) by a distance in the range of at least 8 mm to 25 mm.
[0019]
19. Reverse shoulder prosthesis, characterized in that it comprises: a humeral adaptation tray (300) configured to be seated next to a surface extracted from a humerus, the humeral adaptation tray (300) comprising: a cavity ( 202, 302); a central hole (220); and a distal face including a protrusion (210, 310), wherein the protrusion (210, 310) is: (i) configured as an extension of the distal face, (ii) superiorly offset from the central hole (220) by at least 8 mm, and (iii) configured to engage a humeral stem (400); and a humeral liner (250) comprising: a distal lip (252) configured to seat within the cavity (202, 302) of the humeral adapter tray (300); and a concave hinge surface configured to be in correspondence with a convex hinge surface of a glenosphere (500).
[0020]
20. Reverse shoulder prosthesis, according to claim 19, characterized in that the protrusion (210, 310), in addition to being superiorly deviated, is subsequently deviated from the central hole (220) by at least 10 mm.

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法律状态:
2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

2020-04-07| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

2021-04-06| B08F| Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]|Free format text: REFERENTE A 8A ANUIDADE. |

2021-07-13| B08G| Application fees: restoration [chapter 8.7 patent gazette]|

2021-10-13| B350| Update of information on the portal [chapter 15.35 patent gazette]|

2021-11-16| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

2022-01-25| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 30/05/2013, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

申请号 | 申请日 | 专利标题

US201261653860P| true| 2012-05-31|2012-05-31|

US61/653,860|2012-05-31|

US201361779363P| true| 2013-03-13|2013-03-13|

US61/779,363|2013-03-13|

US13/905,599|US8888855B2|2012-05-31|2013-05-30|Reverse shoulder humeral adapter trays|

US13/905,599|2013-05-30|

PCT/US2013/043321|WO2013181365A1|2012-05-31|2013-05-30|Reverse shoulder humeral adapter trays|

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