throbber

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`11111111111111111 111111111111111111111IIIIIIIIIIIIII
`
`(12) United States Patent
`Running et al.
`
`(10) Patent No.: US 12,023,254 B1
`*Jul. 2, 2024
`(45) Date of Patent:
`
`(54) TOTAL REVERSE SHOULDER SYSTEMS
`AND METHODS
`
`(71) Applicant: Shoulder Innovations, Inc., Grand
`Rapids, MI (US)
`
`(72)
`
`Inventors: Donald E. Running, Holland, MI (US);
`Robert J. Ball, West Olive, MI (US);
`Jason Slone, Silver Lake, IN (US)
`
`(73) Assignee: Shoulder Innovations, Inc., Grand
`Rapids, MI (US)
`
`*)
`
`Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`This patent is subject to a terminal dis-
`claimer.
`
`(21)
`
`Appl. No.: 18/605,361
`
`(22)
`
`Filed:
`
`Mar. 14, 2024
`
`Related U.S. Application Data
`
`(63)
`
`(60)
`
`Continuation of application No. 17/435,333, filed as
`application No. PCT/US2020/022094 on Mar. 11,
`2020.
`Provisional application No. 62/816,708, filed on Mar.
`11, 2019.
`
`(51)
`
`Int. Cl.
`A61F 2/30
`A61B 17/17
`A61B 17/80
`A61B 17/86
`A61F 2/40
`(52) U.S. Cl.
`CPC
`
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`
`A61F 2/4081 (2013.01); A61B 17/1778
`(2016.11); A61F 2/30749 (2013.01); A61F
`2002/30616 (2013.01); A61F 2002/4085
`(2013.01)
`
`(58) Field of Classification Search
`None
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`2,781,758 A
`3,979,778 A
`4,003,095 A
`
`2/1957 Jacques
`9/1976 Stroot
`1/1977 Gristina
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
`
`AU
`DE
`
`3/2024
`2018251815
`12/1993
`4220217
`(Continued)
`
`OTHER PUBLICATIONS
`
`U.S. Appl. No. 13/018,341, filed Jan. 31, 2011, Gunther.
`(Continued)
`
`Primary Examiner — Ann Schillinger
`(74) Attorney, Agent, or Firm Knobbe Martens Olson
`& Bear, LLP
`
`(57)
`
`ABSTRACT
`
`A reverse shoulder system can include, for example, a
`glenoid baseplate comprising a longitudinal axis, the glenoid
`baseplate further including a stem and a central channel
`within a sidewall of the stem. The stem can include a
`longitudinal axis. The longitudinal axis of the glenoid base-
`plate can be angled with respect to the longitudinal axis of
`the stem, wherein the longitudinal axis of the glenoid
`baseplate is not perpendicular with respect to the longitudi-
`nal axis of the stem. Other components including a gleno-
`sphere, tools, and methods of use are also disclosed.
`
`22 Claims, 21 Drawing Sheets
`
`2OO
`
`/
`/O2
`
`7
`
`1OO
`
`2O2
`
`.3:OO
`
`CATALYST, EX-1001
`PAGE 1
`
`

`

`US 12,023,254 B1
`Page 2
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`

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`US 12,023,254 B1
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`1
`TOTAL REVERSE SHOULDER SYSTEMS
`AND METHODS
`
`This application is a continuation of U.S. application Ser.
`No. 18/477,416, filed Sep. 28, 2023, which is a continuation
`of U.S. application Ser. No. 18/058,058, filed Nov. 22, 2022,
`now U.S. Pat. No. 11,771,561, which is a continuation of
`U.S. application Ser. No. 17/435,333, filed Aug. 31, 2021,
`which is the national phase of International Application No.
`PCT/US2020/022094, filed Mar. 11, 2020, which claims the
`benefit of priority from U.S. Provisional No. 62/816,708,
`filed Mar. 11, 2019, which are all hereby incorporated by
`reference in their entireties.
`
`BACKGROUND
`
`Shoulder replacement is a commonly performed medical
`procedure for treatment of osteoarthritis, rheumatoid arthri-
`tis, as well as for treatment of certain deformities related to
`oncological indications as well as trauma. There are two
`primary types of articulations available to surgeons for
`treatment: anatomic and reverse. With anatomic, the surgeon
`replaces the articular surfaces with industrial materials such
`that the articulating surfaces are substantially the same shape
`as the natural anatomy. A stem can be commonly fixed inside
`the canal of the humerus, a metallic articular head can be
`rigidly fixed to the proximal aspect of the same, the articular
`head having a convex articular surface adapted to articulate
`with the glenoid implant. The glenoid implant can include
`on its back side (medial side) certain pegs or posts or fins
`adapted to be rigidly fixed within the glenoid fossa of the
`scapula and on its front side a concave or flat articular
`surface adapted to articulate with the humeral head of the
`humeral implant.
`When a reverse prosthesis is used, the articular surface is
`reversed in that the metallic ball is rigidly fixed to the
`glenoid fossa of the scapula, and the concave articular
`surface is rigidly fixed to the humeral bone, thereby revers-
`ing the fashion of articulation of the prosthesis.
`The surgeon chooses between the two types of prostheses
`by assessing a number of conditions of the patient including
`level of pain, patient activity level, deformity or severity of
`the boney degradation, the strength of surrounding soft
`tissues, and present or absence of prior surgery, and particu-
`larly the health and strength of the rotator cuff muscle and
`tendon. Disease of the rotator cuff is common among
`patients with arthritis of the shoulder. In this circumstance,
`it is commonly observed that the absence of insufficiency of
`the rotator cuff leads to a condition where the anatomic
`shoulder replacement prosthesis is not sufficiently stabilized
`by surrounding soft tissue. In this case, a reverse shoulder
`replacement prosthesis can be preferred in some cases due to
`the higher inherent stability of the articulation. In addition,
`the reverse prosthesis can advantageously utilize the remain-
`ing muscles in a way they can be more effective in the
`absence of the other soft tissue structures by adjusting the
`position of the articular surfaces within the joint.
`
`SUMMARY
`
`In some embodiments, disclosed herein is a reverse shoul-
`der system, comprising any number of a glenoid baseplate
`comprising a longitudinal axis, the glenoid baseplate further
`comprising a stem and a central channel within a sidewall of
`the stem, the stem comprising a longitudinal axis. The
`longitudinal axis of the glenoid baseplate can be angled with
`respect to the longitudinal axis of the stem, wherein the
`
`5
`
`10
`
`2
`longitudinal axis of the glenoid baseplate is not perpendicu-
`lar with respect to the longitudinal axis of the stem.
`In some configurations, the glenoid baseplate comprises a
`generally disc-shaped portion extending radially outward
`from the central channel.
`In some configurations, the stem comprises a sidewall that
`extends superiorly with respect to the disc portion.
`In some configurations, the glenoid baseplate comprises a
`peripheral edge.
`In some configurations, the peripheral edge comprises
`spaced-apart anti-rotation features.
`In some configurations, the anti-rotation features com-
`prise slots.
`In some configurations, an inferior portion of the periph-
`15 eral edge comprises a porous coating.
`In some configurations, an inferior surface of the gener-
`ally disc-shaped portion comprises a porous coating, but a
`superior surface does not comprise a porous coating.
`In some configurations, the peripheral edge and/or an
`20 inferior surface of the baseplate comprises a conical geom-
`etry.
`In some configurations, an inferior surface of the base-
`plate is concave.
`In some configurations, the stem comprises a Morse taper
`25 lock superior to a superior-most portion of the generally
`disc-shaped portion of the glenoid baseplate.
`In some configurations, the system further comprises a
`glenosphere.
`In some configurations, the glenosphere comprises a
`30 superior dome-shaped surface comprising a rotational con-
`trol feature configured such that an inserter tool can lock the
`glenosphere and the baseplate to allow for rotation of the
`glenosphere and the baseplate together.
`In some configurations, the rotational control feature
`35 comprises a spline.
`In some configurations, the system further comprises a
`central set screw and locking nut.
`In some configurations, the system further comprises a
`central compression screw non-integral with the baseplate
`40 and configured for placement adjacent and distal to the
`central set screw.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`55
`
`45
`
`These drawings are illustrative embodiments and do not
`present all possible embodiments of this invention.
`FIG. 1 illustrates an embodiment of components of a total
`reverse shoulder system.
`FIG. 2 illustrates various embodiments of humeral trays
`so that can be utilized with total reverse shoulder systems,
`according to some embodiments.
`FIG. 3 illustrates a variety of humeral bearing compo-
`nents that can be utilized with total reverse shoulder sys-
`tems, according to some embodiments.
`FIG. 4 illustrates schematically an embodiment of a
`glenoid baseplate configured to be inset into the glenoid.
`FIG. 5 illustrates schematically an embodiment of a
`glenoid baseplate 500 configured to be inset into the glenoid.
`FIG. 6 illustrates a threaded locking insert for a central
`60 channel of a stem/post, according to some embodiments.
`FIG. 7 illustrates various views of glenospheres, accord-
`ing to some embodiments.
`FIG. 8 illustrates a schematic cross-section of a fully
`assembled glenosphere with a locking bolt, according to
`65 some embodiments.
`FIGS. 8A-8U illustrate a glenoid surgical technique,
`according to some embodiments.
`
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`US 12,023,254 B1
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`3
`FIG. 9 illustrates an embodiment of a sizer/angle guide.
`FIG. 10 illustrates an embodiment of a stem drill guide.
`FIG. 11 schematically illustrates a stem angle change with
`a rotational adjustment.
`FIG. 12 schematically illustrates views of a glenoid
`baseplate inserter (alone on the left and together with a
`baseplate on the right), according to some embodiments.
`FIG. 13 schematically illustrates views of a calibrated
`central drill, according to some embodiments.
`FIG. 14 schematically illustrates views of fixed angle
`peripheral drill guides, according to some embodiments.
`FIG. 15 schematically illustrates views of variable angle
`peripheral drill guides, according to some embodiments.
`FIG. 16 schematically illustrates side and top views of
`central screws, according to some embodiments.
`FIG. 17 schematically illustrates side and top views of
`fixed angle peripheral compression screws, according to
`some embodiments.
`FIG. 18 schematically illustrates side and top views of
`variable angle peripheral screws, according to some embodi-
`ments.
`FIG. 19 schematically illustrates views of a glenosphere
`inserter, according to some embodiments.
`
`DETAILED DESCRIPTION
`
`In some embodiments, disclosed herein are various
`embodiments of a total reverse shoulder system, including a
`variety of humeral trays, humeral bearings, inset glenoid
`baseplates, threaded locking inserts, and glenospheres. Gle-
`noid surgical techniques are also described, which can
`utilize various tools including but not limited to sizer/angle
`guides, stem drill guides, glenoid baseplate inserters, cali-
`brated central drills, peripheral drill guides with fixed or
`variable angles, central screws, fixed angle peripheral com-
`pression screws, variable angle peripheral screws, and gle-
`nosphere inserters. Dimensions listed on the accompanying
`Figures are non-limiting examples only.
`FIG. 1 illustrates an embodiment of components of a total
`reverse shoulder system, including a glenosphere 200 and a
`glenoid baseplate 102 which can be partially or completely
`inset in some embodiments. The glenoid baseplate 102 can
`be a generally disc-shaped structure and include a central
`aperture defining a surface of (e.g., integral with an elongate
`stem), or configured to fit an elongate stem or post there-
`through. The glenoid baseplate 102 can include a longitu-
`dinal axis that is at an angle to a longitudinal axis of the
`elongate stem 100. The longitudinal axis of the glenoid
`baseplate 102 can be at an angle, such as generally oblique
`with respect to the longitudinal axis of the elongate stem
`100. In some embodiments, the angle is an acute angle, and
`not a right angle. The angle between the two intersecting
`longitudinal axes of the respective baseplate 102 and the
`stem 100 could be, for example, about, at least about, or no
`more than about 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60,
`65, 70, 75, 80, 85, 90, or more or less degrees, or ranges
`including any two of the foregoing values.
`FIG. 2 illustrates various embodiments of humeral trays
`that can be utilized with total reverse shoulder systems,
`according to some embodiments. The humeral trays can
`include various inner diameters IDs and outer diameters
`ODs, including 30 mm, 32 mm, 34 mm, 36 mm, 38 mm, 40
`mm, 42 mm, or more or less IDs and/or ODs, and ranges
`including any two of the foregoing values. The trays can
`include one or more pegs, such as a central peg extending
`from a medial surface. The trays can be neutral, or include
`extensions (e.g., in thickness) that can be, for example, +2,
`
`4
`4, 6, 8, 10, 12 mm, or ranges including any two of the
`foregoing values. The trays can include various cross-
`sections, including oval or round cross-sections. The trays
`can be compatible with the same poly bearing surfaces in
`5 some cases. In some embodiments, a kit can include at least
`four different sizes of trays (34 mm oval neutral; 34 mm
`oval+6 mm extension; 38 mm round neutral; 38 mm
`round+6 mm extension.
`FIG. 3 illustrates a variety of humeral bearing compo-
`io nents that can be utilized with total reverse shoulder sys-
`tems, according to some embodiments, including humeral
`trays as illustrated and described in connection with FIG. 2.
`The bearing components can include, for example, a periph-
`eral ring 302 and a central recessed portion that can be
`is outlined radially outwardly by an inner edge of the periph-
`eral ring, and an inner bowl-shaped portion 304. The periph-
`eral ring can include indicia, such as a slot or other marking
`399 illustrating the highest point of the bearing component.
`Also illustrated is the recessed poly dome 395, and a partial
`20 or full annular barb 397 around the outer circumference of
`the bearing component. The bearing component can include
`a variety of geometries include neutral, 1, 2, 3, 4, 5, 6, 7, 8,
`9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 degree angles to
`horizontal, or ranges including any two of the foregoing
`25 values. In some embodiments, the bearing component does
`not change the joint center. In some embodiments, the
`bearing component can include 30, 31, 32, 33, 34, 35, 36, 37,
`38, 39, 40, 41, 42, 43, 44, 45 mm, or more or less spherical
`diameters, or ranges including any two of the foregoing
`30 values. In some embodiments, systems and methods can
`include an offset of 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 mm, or
`ranges including any two of the foregoing values.
`FIG. 4 illustrates schematically an embodiment of a
`glenoid baseplate configured to be inset into the glenoid G
`35 as illustrated. The longitudinal axis of the baseplate can be
`angled with respect to the longitudinal axis of the stem/post
`as described, for example, with respect to FIG. 1, and can
`include a version change 499 to compensate for posterior
`bony defects. In some embodiments, the glenoid baseplate
`40 includes a central channel therethrough defining a surface of
`(e.g., integral with an elongate stem), or configured to fit
`configured to house a stem/post as shown. The glenoid
`baseplate can include a generally conical shape with a
`concave undersurface configured to rest withi

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