Note: Descriptions are shown in the official language in which they were submitted.
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REVERSE SHOULDER PROSTHESIS
RELATED APPLICATION
This is a divisional of Canadian Patent Application Serial No. 2,853,437 filed
on June 4, 2014, which is a divisional of National Phase Application Serial
No. 2,646,995
filed on March 23, 2007.
FIELD OF THE INVENTION
Various embodiments of the present invention relate to an apparatus and
method for reverse shoulder arthroplasty (e.g., reverse total shoulder
arthroplasty). In one
specific example, a glenoid component used to resurface the scapula may be
provided. Of
note, unlike traditional total shoulder arthroplasty the glenoid component in
a reverse shoulder
is convex rather than concave; it acts as a physical stop to prevent the
superior migration of
the humeral head - a typical occurrence in patients suffering from rotator
cuff tear arthropathy
(CTA).
For the purposes of describing the present invention the term "Equinoxe" (such
as, for example, Equinoxe reverse shoulder design or Equinoxe reverse shoulder
prosthesis) is
intended to refer to an embodiment of the present invention.
BACKGROUND OF THE INVENTION
Neer coined the term cuff tear arthropathy in 1972 to describe the arthritic,
eroded/collapsed condition of the glenohumeral joint following
prolonged/progressive
subacromial impingement resulting from massive, full thickness rotator cuff
tears. This
pathology is associated with extreme pain and near complete loss of function.
(see Neer, C.S.
et al. Cuff Tear Arthropathy. JBJS. #65: 1232-1244. 1983).
Cuff tear arthropathy has been historically treated with acromioplasty,
arthroscopic debridement, tendon transfers, humeral tuberoplasty, arthrodesis,
total shoulder
arthroplasty (constrained, semi-constrained, or unconstrained), bipolar
shoulder arthroplasty,
hemiarthroplasty
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(with and without acromial spacers), and most recently (and successfully)
reverse shoulder
arthroplasty.
The Reverse/Inverse shoulder was first conceived by Neer in the early 1970's
to treat
patients suffering from CTA; specifically, this device was intended to provide
pain relief and
prevent progressive acromial, coracoid, and glenoid erosion by resisting
humeral head superior
migration. This was theoretically accomplished by inverting the male and
female ball and socket so
that the glenoid component was now convex and the humerus now concave; doing
so created a
physical stop that prevents the humerus from migrating superiorly. Several
reverse shoulder designs
have since been conceived and developed: the Fenlin, Reeves, Gerard, Kessel,
Kolbel, and the =
Neer-Averill to name but a few; of these, only the Kessel design has reported
long-term outcomes
(it is believed that each of the aforementioned designs have since been
abandoned). Similar to
constrained total shoulder arthroplasty, the fixed center of rotation resulted
in an excessive torque on
the glenoid that compromised fixation, ultimately leading to loosening.
In 1987, Paul Grammont introduced a new reverse shoulder design. It consisted
of 2
components: the glenoid was a metallic or ceramic 42mm ball (-2/3 of a sphere)
and the humeral
component was a polyethylene "trumpet-shaped" cup (whose concave surface was
¨1/3 of a
sphere); the humeral component was fixed with PM/vIA. The preliminary results
of this prosthesis
were published in 1987 (see Grammont, P.M. et al. Etude et Realisation D'une
Novelle Prosthese
D'Paule. Rhumatologie. #39: 17-22. 1987); after a mean follow-up of six
months, all six patients (8
shoulders) were pain-free; however, mobility was variable: 3 patients had
active anterior elevation
between 100-130 , 3 patients had active anterior elevation less than 60 .
These inconsistent results
necessitated a redesign.
In 1991, the Grammont reverse shoulder was redesigned and renamed as the Delta
III
reverse shoulder prosthesis. The cemented glenoid failed; therefore, the
glenosphere was redesigned
to have a fixed central peg and divergent screws. The 2/3 of a sphere in the
glenoid was abandoned
for 1/3 of sphere to place center of rotation directly in contact with glenoid
fossa; thereby, reducing
the torque on the bone surface. The humeral component was designed for either
cemented or.
uncemented applications (see Boileau, P. et al. Grammont Reverse Prosthesis:
Design, Rationale,
and Biomechanics. JSES Jan/Feb: 147S-161S. 2005).
This prosthesis was called the "Delta" because of its functional dependence on
the Deltoid.
The design rationale for the Delta III is described as follows:
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= the center of rotation is shifted medially (to increase the effective
lever arm of the deltoid by
recruiting more of the deltoid fibers for elevation and abduction).
= the center of rotation is shifted distally by lowering the humerus (to
tension the deltoid).
= the center of the glenosphere is placed directly on the glenoid fossa to
limit the torque on the
fixation devices and resist loosening.
= the inverted concavities of the glenohumeral joint create a physical stop
to prevent humeral
head superior migration; the status of the CA arch is irrelevant with this
design.
Whether these theoretical biomechanical benefits of the Delta will actually
become realized
has yet to be determined as there has been limited long-term outcome studies
(>5yrs) which
demonstrate its reliability; however, short-term and medium-term outcome
studies suggest that the.
design provides pain relief and restores function (primarily in
abduction/adduction and partially in
flexion/extension; internal/external rotation is restored on a limited basis
dependant upon the
condition of the infraspinatus and the teres minor). In this regard, see the
following: Boileau, P. et
al. Grammont Reverse Prosthesis: Design, Rationale, and Biomechanics. JSES
Jan/Feb: 147S-1618.
2005; Rittmeister, M. et al. Grammont Reverse Total Shoulder Arthroplasty in
Patients with
Rheumatoid Arthritis and Nonreconstructable Rotator Cuff Lesions. JSES.
Jan/Feb: 17-22.2001;
Vanhove, B. Grammont's Reverse Shoulder Prosthesis for Rotator Cuff
Arthropathy. A
Retrospective Study of 32 Cases. Acta Orthop Belg. #70 (3): 219-225. 2004;
Sirveaux, F. et al.
Grammont inverted total shoulder arthroplasty in the treatment of glenohumeral
osteoartluitis with
massive rupture of the cuff. JBJS 86-B: 388-395. 2004; Katzer, A. Two-Year
Results After
Exchange Shoulder Arthroplasty Using Inverse Implants. Orthopedics. Vol. 27,
#11: 1165-1167.
2004; Walch, G. The Reverse Ball and Socket: When is it Indicated?
Orthopaedics Today. pp. 18-
20.
Of note, the Delta reverse shoulder is associated with a number of different
types of
complications including glenoid loosening, scapular "notching" (more
descriptively called inferior
glenoid erosion), acromion fractures, dislocation (head from poly and poly
insert from humeral
stem), instability, humeral stem fracture, humeral stem loosening, and glenoid
screw fracture. In this
regard, see the immediately preceding cited references.
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BRIEF DESCRIPTION OF THE DRAWINGS
Figs. 1A-1C show three perspective views of a reverse shoulder prosthesis
(including
glenosphere/glenoid plate assembly and humeral mating components) according to
one embodiment
of the present invention;
Fig. 2 shows another perspective view of the embodiment of Figs. 1A-1C;
Figs. 3A-3C show three more detailed perspective views of the
glenosphere/glenoid plate
assembly of the embodiment of Figs. 1A-1C;
Figs. 4A-4D show four more detailed perspective views of the glenosphere of
the
= embodiment of Figs. 1A-1C (the glenosphere of this example is a38 mm
glenosphere);
Figs. 4E-40 show three more detailed perspective views of an example pear-
shaped
glenosphere according to an embodiment of the present invention;
= Figs. 5A-5C show three more detailed perspective views of the pear-shaped
glenoid plate of
the embodiment of Figs. 1A-1C (showing a stem provided with holes for bone
"through growth");
Figs. 5D-5F show three more detailed perspective views of another example pear-
shaped
glenoid plate according to an embodiment of the present invention (showing a
stein provided with
holes for bone "through growth");
Fig. 6 shows a perspective view of an example compression screw of the type
which may be
utilized with the present invention;
Figs. 7A-7C show 'three perspective views of an example locking cap screw of
the type
which may be utilized with the present invention;
Figs. 7D-7F show three views of an example torque defining screw driving
element which
may be utilized with the present invention;
=
Figs. 8A and 8B show two views of the glenosphere/glenoid plate assembly of
the
embodiment of Figs. 1A-1C (wherein the glenosphere is shown in phantom);
. Figs. 9A-9C show: (1) the glenoid plate/compression screw/locking cap
screw assembly of
the embodiment of Figs. 1A-1C; (2) detail of the compression screw/locking cap
screw; and (3)
detail of the compression screw/locking cap screw (wherein the locking cap
screw is shown in
phantom);
= Figs. 10A-10C show three views of a reverse shoulder humeral liner
according to an
embodiment of the present invention;
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Figs. 11A-11E show five views of a reverse shoulder humeral plate according to
an
embodiment of the present invention;
Fig. 12 shows an outline of a pear-shaped glenoid and results from 2 anatomic
studies:
Iannotti, J.P. etal. The Normal Glenohumeral Relationships. JBJS. Vol. 74-A,
44: 491-500 1992
=
and Checroun, A.J. et al. Fit of Current Glenoid Component Designs: an
Anatomic Cadaver Study.
JSES. Vol. 11, 46: 614-617. 2002 (image modified from Checroun);
Fig. 13 shows the fit of a conventional reverse glenosphere plate on glenoid
(image =
modified from Checroun, A.J. et al. Fit of Current Glenoid Component Designs:
an Anatomic
Cadaver Study. JSES. Vol. 11, #6: 614-617.2002);
Fig. 14 shows an area of best quality/deepest glenoid bone (image modified
from Checroun,
A.J. et al. Fit of Current Glenoid Component Designs: an Anatomic Cadaver
Study. JSES. Vol. 11,
46: 614-617. 2002);
Fig. 15 shows a theoretical improvement in probability of A/P bone-screw
purchase if hole
pattern is modified as shown according to an embodiment of the present
invention (image modified
from Checroun, A.J. et al. Fit of Current Glenoid Component Designs: an
Anatomic Cadaver Study.
JSES. Vol. 11,#6: 614-617.2002);
Figs. 16A-16D show four perspective views of a reverse shoulder prosthesis
(including
glenosphere/glenoid plate assembly and humeral mating components) according to
an embodiment
of the present invention;
Figs. 17A-17D show four more detailed perspective views of the oval-shaped
glenoid plate.
of the embodiment of Figs. 16A-16D (showing a superiorly-shifted stem provided
with holes for
bone "through growth");
Figs. 18A-18D show four more detailed perspective views of another example of
an oval-
shaped glenoid plate of an embodiment of the present invention (showing a
superiorly-shifted non-
cylindrical stem provided with holes for bone "through growth");
Figs. 19A-19D show four more detailed perspective views of the glenosphere of
the
embodiment of Figs. 16A-16D (the glenosphere of this example is a 38 mm
glenosphere); =
Figs. 20A and 20B show two views of the glenosphere/glenoid plate assembly of
the
embodiment of Figs. 16A-.16D (wherein the glenosphere is shown in phantom in
Fig. 20B and
wherein the glenosphere of this example is a 38 ram glenosphere);
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Figs. 21A-21D show four more detailed perspective views of an example oval-
shaped
glenosphere of an embodiment of the present invention (the glenosphere of this
example is a 42 mm
glenosphere);
Figs. 22A and 22B show two views of an oval-shaped glenosphere/glenoid plate
assembly
of an embodiment of the present invention (wherein the glenosphere is shown in
phantom in Fig. =
22B and wherein the glenosphere of this example is a 38 mm glenosphere);
Figs. 23A-23D show four more detailed perspective views of an example
glenosphere of an
embodiment of the present invention (the glenosphere of this example is a 46
mm glenosphere);
Figs. 24A and 24B show two views of an glenosphere/glenoid plate assembly of
an
embodiment of the present invention (wherein the glenosphere is shown in
phantom in Fig. 24B and
wherein the glenosphere of this example is a 42 mm glenosphere);
Fig. 25 shows a perspective view of an example compression screw of the type
which may
be utilized with the present invention;
Fig. 26 is a graph showing testing results demonstrating that a 100 reduction,
in neck
angle results in a downward shift in range of motion (ROM);
Fig 27 shows conditions discussed in a study by Nyffeler;
Fig. 28 shows a number of views of a glenoid plate according to another
embodiment of
the present invention;
Fig. 29 shows a modified image from Nyffeler study in which the clinical
effectiveness
of 4 different Glenosphere positions were examined;
Figs. 30A and 30B show another embodiment of the present invention related to
glenoid
plate hole positions that are designed to allow conversion or revision of a
traditional pegged
glenoid;
Figs. 31A and 31B show another embodiment of the present invention related to
glenoid
plate hole positions that are designed to allow conversion or revision of a
traditional keeled =
glenoid;
Fig. 32 shows another embodiment of the present invention related to
anterior/posterior
glenosphere flats;
Fig. 33 shows another embodiment of the present invention related to a bone
cage;
Fig. 34 shows a diagram associated with the definition of inferior and
superior
impingement;
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Fig. 35 shows a diagram associated with the definition of jump distance;
Fig. 36 shows a diagram associated with the defmition of offset;
Fig. 37 shows a diagram associated with the definition of humeral constraint;
Fig. 38 shows a diagram associated with a typical Grammont reverse shoulder
ROM;
Fig. 39 shows a graph of effect of humeral neck angle on ROM and jump
distance;
Fig. 40 shows a chart of effect of varying humeral neck angle on points of
impingement
(shaded data column third from right denotes typical Grammont design);
Fig. 41 shows a chart of effect of varying humeral constraint on ROM (middle
shaded
=
data column denotes typical Grammont design);
Fig. 42 shows a chart of effect of varying glenosphere thickness on ROM
(middle shaded
data column denotes typical Grammont design);
Fig. 43 shows a chart of effect of varying glenosphere diameter on jump
distance (shaded
data column second from left denotes typical Grammont design);
Fig. 44 shows an image from the Nyffeler study depicting the degree of
inferior
impingement when the humeral stem is placed in neutral position;
Fig. 45 shows another embodiment of a
reverse shoulder prosthesis;
Fig. 46 shows another embodiment of a
reverse glenoid plate design;
Fig. 47 shows another embodiment of a reverse
glenosphere design;
Fig. 48 shows other embodiments of a reverse
humeral plate design;
Fig. 49 shows other embodiments of a reverse
humeral liner design;
Fig. 50 shows, another embodiment of a reverse torque defining screw driver
design;
Fig. 51 shows another embodiment of a compression screw design;
Fig. 52 shows another embodiment of a reverse
=
glenosphere locking screw design (the threads are not shown in this view);
Fig. 53 shows another embodiment of a locking cap design;
Fig. 54 shows a diagram associated with a defined point of inferior
impingement;
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=
Fig. 55 shows a diagram associated with a defined point of superior
impingement;
Fig. 56 shows ROM associated with another embodiments of a reverse shoulder
prosthesis;
Fig. 57 shows a graph associated with a comparison of Jump Distance vs,
Abduction/Adduction for an embodiment of the present invention and a typical
Grammont
Reverse Shoulder Prosthesis; and
Fig. 58 shows a chart of comparison of ROM for an embodiment of the present
invention
and a typical Grammont Reverse shoulder prostheses.
Among those benefits and improvements that have been disclosed, other objects
and
advantages of this invention will become apparent from the following
description taken in
conjunction with the accompanying figures. The figures constitute a part of
this specification and
include illustrative embodiments of the present invention and illustrate
various objects and features,
thereof.
DETAILED DESCRIPTION OF THE INVENTION
Detailed embodiments of the present invention are disclosed herein; however,
it is to be
understood that the disclosed embodiments are merely illustrative of the
invention that may be
embodied in various forms. In addition, each of the examples given in
connection with the various
embodiments of the invention are intended to be illustrative, and not
restrictive. Further, the figures
are not necessarily to scale, some features may be exaggerated to show details
of particular
components. Therefore, specific structural and functional details disclosed
herein are not to be
interpreted as limiting, but merely as a representative basis for teaching one
skilled in the art to
variously employ the present invention.
Of note, various embodiments of the present invention are directed to a
reverse shoulder
prosthesis incorporating some or all of the aforementioned benefits associated
with the Delta reverse
shoulder design (while also aiming to minimize the number and rate of observed
complications).
These benefits of various embodiments of the present invention may include
(but are not limited to):
1) lengthen/tension deltoid to improve muscle efficiency; 2) maintain center
of rotation on the
glenoid fossa to minimize the effective moment arm; and/or 3) invert the
concavities of the natural
joint to create a physical stop to prevent humeral head superior migration.
The complications that
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various embodiments of the present invention may minimize include (but are not
limited to):
1) eliminate impingement to reduce the degree of scapular notching and the
incidence of
dislocation; 2) improve glenoid fixation by increasing the number of available
fixation points,
positioning the fixation points in such a manner that it maximizes the
potential for fixation
(e.g., position the fixation points in such a manner that their location
corresponds to the region
of best quality/deepest bone in the native glenoid), allowing for all screws
to be
oriented/angled in any direction (to improve possibility of screw purchase),
and/or allowing
for any compression screw (regardless of its angular orientation) to be
converted into a
locking screw (to prevent the screws from backing out); 3) reduce glenoid
osteolysis by
improving stress transfer through the use of an anatomic shaped glenoid plate
(e.g., the
anatomic plate limits overhang on the ATP sides of the glenoid); and/or 4)
improve stability
and ROM by allowing the use of a larger diameter glenosphere (certain
embodiments of the
present invention may not require reaming of the proximal humerus, as is
typically required in
the Grammont design. . .often the proximal humerus establishes the size of the
glenosphere
based upon the maximum size of liner that can be placed).
Some embodiments disclosed herein relate to a glenosphere for a reverse
shoulder prosthesis including a humeral liner and a glenoid plate, comprising:
a glenosphere
body having an articular surface configured to interface with the humeral
liner; wherein the
articular surface is generally spherical where the articular surface
interfaces with the humeral
liner; and wherein the articular surface has an arc, in at least one
dimension, of greater than
180 degrees.
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Referring now to Figs. 1A-1C and 2, various views of an assembled construct
100 according to an embodiment of the present invention are shown. The
components of this
construct may include: a humeral stem 102 (which may be used in either
pressfit or cemented
applications and may be constructed, for example, from titanium); a humeral
liner 104 (a
concave component which mates with the convex glenosphere, this element may be
constructed, for example, from UHMWPE); a humeral adapter plate 106 (which
connects the
humeral liner to the humeral stem, this element may be constructed, for
example, from
titanium); a glenosphere 108 (this element may be constructed, for example,
from cobalt
chrome); a pear-shaped glenoid plate 110 (this element may be constructed, for
example, from
titanium); and a number of screws and fixation devices for assembly of the
individual
components to one another and for assembly of the construct to the native bone
(these
elements may be constructed, for example, from titanium). Of note, the glenoid
plate of this
example is pear-shaped.
Referring now to Figs. 3A-3C, more detailed views of the glenosphere/glenoid
plate assembly of Figs. 1A-1C and 2 are shown (stem 112 is seen clearly in
these Figs.).
Referring now to Figs. 4A-4D, more detailed views of the glenosphere of
Figs. 1A-1C and 2 are shown (note that the glenosphere may be hollowed out to
reduce
weight).
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Referring now to Figs. 4E-4G, detailed views of another example glenosphere
are shown
(note that the glenosphere may be hollowed out to reduce weight).
Referring now to Figs. 5A-5C, more detailed views of the pear shaped glenoid
plate of Figs.
1A-1C and 2 are shown. In this regard, several features should be noted: 1)
the 6 screw holes on the
backside of the plate; and 2) the bone "through-growth" cage stem which
enables bone graft to be
injected (e.g., via syringe) through the front of the plate and/or placed
through the hole in the bottoin
surface of the cage stem).
Referring now to Figs. 5D-5F, detailed views of another example pear-shaped
glenoid plate
110A are shown.
Referring now to Fig. 6, a compression screw 114 according to an embodiment of
the
present invention is shown (note the spherical head which enables the screw to
be angularly oriented
within glenoid plate 110 (e.g., up to 17.5 degrees) in any desired direction ¨
in one specific
example, the holes in glenoid plate 110 may have corresponding concavities).
Referring now to Figs. 7A-7C, a locking cap screw 116 according to an
embodiment of the
present invention is shown (a locking cap screw may screwed into the glenoid
plate on top of a
compression screw to prevent the compression screw from backing out and/or to
lock the
compression screw in a desired angular orientation ¨ see Figs. 8A, 8B, and 9A-
9C). Further, Figs.
7D-7F show three views of a torque defining screw driving element 118 which
may be utilized with
the present invention (e.g., to drive a screw and/or locking cap with a
predefined amount of torque.
(e.g., by breaking when the predefined amount of torque is applied)).
Referring now more particularly to Figs. 8A and 8B, more detailed views
demonstrating
how the compression screw 114 and locking cap screw 116 mate with the glenoid
plate 110 are
shown. These Figs. 8A and 8B also show how glenosphere 108 (depicted here in
phantom form)
may be assembled to glenoid plate 110 via use of assembly bolt 118. Figs. 9A-
9C further clarify the
relationship of the compression screw 114 and locking cap screw 116 to the
glenoid plate 110.
These Figs. 9A-9C also detail the spherical articulation between the
compression screw 114 and
locking cap screw 116¨ a feature which enables the compression screw 114 to be
locked regardless
of its angular orientation. =
Referring now to Figs. 10A-10C, three views of humeral liner 104 of Figs. 1A-
1C and 2 are
show.
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Referring now to Figs. 11A-11E, five views of humeral plate 106 of Figs. 1A-1C
and 2 are
show.
Referring now to Figs. 16A-16D, various views of an assembled construct 1600
according
to an embodiment of the present invention are shown. The components of this
construct may
include: a humeral stem 1602 (which may be used in either pres.sfit or
cemented applications and
may be constructed, for example, from titanium); a humeral liner 1604 (a
concave component
which mates with the convex glenosphere, this element may be constructed, for
example, from
UHMWPE); a humeral adapter plate 1606 (which connects the humeral liner to the
humeral stem,
this element may be constructed, for example, from titanium); a glenosphere
1608 (this element
may be constructed, for example, from cobalt chrome); an oval-shaped glenoid
plate 1610 (this =
element may be constructed, for example, from titanium); and a number of
screws and fixation
devices for assembly of the individual components to one another and for
assembly of the construct
to the native bone (these elements may be constructed, for example, from
titanium). Of note, the
glenoid plate 1610 of this example is oval-shaped.
Referring now to Figs. 17A-17D, more detailed views of the oval-shaped glenoid
plate of
Figs. 16A-16D are shown (stem 1612 is seen clearly in these Figs.).
Referring now to Figs. 18A-18D, more detailed views of another example oval-
shaped
glenoid plate 1610A are shown (stem 1612A is non-cylindrical in these Figs.).
Referring now to Figs. 19A-19D, more detailed views of the glenosphere of
Figs. 16A-16D
are shown (note that the glenosphere may be hollowed out to reduce weight).
Referring now to Figs. 20A-20B, more detailed views of the glenoid
plate/glenosphere
assembly of Figs. 16A-16D are shown (the glenosphere of Fig. 20B is shown in
phantom form).
Referring now to Figs. 21A-21D, more detailed views of another example
glenosphere are
shown.
Referring now to Figs. 22A-22B, more detailed views of an example glenoid
plate/glenosphere assembly. are shown (the glenosphere of Fig. 22B is shown in
phantom form).
Referring now to Figs. 23A-23D, more detailed views of another example
glenosphere are
shown.
Referring now to Figs. 24A-24B, more detailed views of an example glenoid
plate/glenosphere assembly are shown (the glenosphere of Fig. 24B is shown in
phantom form). =
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Referring now to Fig. 25, a compression screw 1614 according to an embodiment
of the
present invention is shown (note the spherical head which enables the screw to
be angularly oriented
within glenoid plate 1610 (e.g., up to 17.5 degrees) in any desired direction¨
in one specific
example, the holes in glenoid plate 1610 may have corresponding concavities).
Of course, it should be noted that there are other embodiments of the
invention and/or of the
individual components comprising the invention, including (but not limited to)
various shapes,
sizes, and materials. For example '(which example is intended to be
illustrative and not restrictive),
the materials of the humeral liner and glenosphere could be inverted (reverse
designs typically have
a metal glenosphere/glenoid plate and a plastic humeral liner ¨ an alternative
embodiment is a metal
humeral liner and a plastic. glenosphere) ¨ doing so could theoretically
reduce the weight cyclically
imposed on the native glenoid bone (by eliminating many of the much heavier
metal components).
This may also reduce the cost of the device by eliminating the need for
multiple metal screws and
fixation components. In another example (which example is intended to be
illustrative and not
restrictive), if both the glenosphere and glenoid plate were manufactured of
plastic then the device =
could be used exclusively in cemented applications ¨ an application that has
been shown to be the
standard of care in traditional shoulder arthroplasty. Conversely, both the
humeral liner and the
glenosphere/plate could be manufactured from the same material then a metal-on-
metal (or ceramic-
on-ceramic) articulation could be achieved (which have been shown to produce
less wear in hip
arthroplasty applications and as a result have a lower incident of
osteolysis). In yet another example
(which example is intended to be illustrative and not restrictive), the
glenoid plate design may have
a central screw rather than a central cage stem (the central screw hole could
be advantageous in
cases in which a central bone defect exists; the screw could be oriented in
various directions to
ensure that screw purchase is obtained).
Of note, various embodiments of the present invention may offer a number of
advantages
over the prior art¨ some of these advantages are described above. Figs. 12-15
further elaborate on
some of these advantages.
More particularly, Fig. 12 summarizes the results of two different anatomic
studies (see .
J.P. etal. The Normal Glenohumeral Relationships. JBJS. Vol. 74-A, #4: 491-
500. 1992
and Cheeroun, A.J. et al. Fit of Current Glenoid Component Designs: an
Anatomic Cadaver Study.
JSES. Vol. 11, #6: 614-617. 2002) - each of these studies demonstrate that the
glenoid is wider
inferiorly than superiorly and that it has a characteristic pear or "inverted-
comma" shape.
=
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Further, Fig. 13 graphically illustrates the fit of a traditional Grammont-
style glenoid plate
on a representative glenoid fossa; it is believed that the typical 4-quadrant
location of the screw
holes is not ideal due to the anterior and posterior slope of the scapula¨
this slope results in a thin
=
base of bone in these locations.
Further still, Fig. 14 graphically illustrates the region of best
quality/deepest bone in the
= native glenoid.
Finally, Fig. 15 graphically illustrates the rationale for screw hole position
utilized in an
embodiment of the present invention.
In other examples (which examples are intended to be illustrative and not
restrictive), the
present invention may be constructed as follows:
= Reverse Shoulder Glenoid Plate
o Material: Machined from Wrought Ti-6A1-4V
o Scope: 1 Size (used with 38, 42, and 46mm Glenosphere);
o Dimensions/Features: 29mm diameter, 5rnm taper, 20nun length bone "through
growth" cage, each screw hole has a spherical base allowing the compression
screws
to be angled 15 , each hole also has a threaded portion for attachment of a
locking .
cap screw.
= Reverse Shoulder Glenosphere
o Material: Machined from Cast Co-Cr
o Scope: 3 Sizes (38/22mm, 42/24mm, and 46/26mm Diameter and Thickness)
o Dimensions/Features: Glenosphere hollowed out to reduce weight
= Reverse Shoulder Humeral Liner
o Material: Machined from Compression Molded UTIMWPE Bar (Enhanced Poly:
Connection GXL)
o Scope: 3 Diameters (38, 42, and 46mm Liners); Multiple offsets
o Dimensions/Features: Connection to humeral plate configured for
rotational stability
(e.g., "mushroom" or other non-circular shape).
14
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= Reverse Shoulder Humeral Plate
o Material: Machined from Wrought Ti-6A1-4V
o Scope: 3 Sizes (38, 42, and 46mm)
_ o
=
o Dimensions/Features: Connection to liner configured for rotational
stability (e.g.,
"mushroom" shaped or other non-circular shape); male pin(s) may connect to
humeral stem for rotational stability
20 = Reverse Shoulder Compression Screw
= Material: Machined from Ti-6A1-4V or SS Alloy
o Scope: 1 diameter (4.0mm) at multiple lengths
o Dimensions/Features: Spherical head for insertion at a variable angle
(e.g., up to
15 ); cannUlated
= Reverse Shoulder Locking Cap Screw
o Material: Machined from Ti-6A1-4V or SS Alloy
o Scope: 1 size (-9mm long, 8mm wide)
o Dimensions/Features: Locks compression screws to glenoid plate at any
angle;
cannulated; fits in hollowed out space of glenosphere.
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= Glenosphere Locking Screw
o Material: Machined from Ti-6A1-4V or SS Alloy
o Scope: 1 size (-25rnm long, 4mm wide)
o Dimensions/Features: Locks glenosphere to glenoid plate.
= Reverse Shoulder Torque Defining Screw Driving Element
o Material: Machined from wrought Ti-6A1-4V; UFTMWPE plug
o Scope: 1 Size; minimum cross section as required
o Dimensions/Features: Design Utilizes poly plug to retain square head
after fracture
According to another example (which example is intended to be illustrative and
not
restrictive), the present invention may provide for:
=
D The reverse prosthesis may be integrated with the primary system ¨ may
retain the primary
stem for revision (which is beneficial because ¨30% of reverse shoulders are
implanted as
revisions). Additionally, the prosthesis may use existing humeral implant
inventory, existing
humeral instrumentation, and/or a similar surgical technique (e.g., may
maintain a 132.5
humeral osteotomy).
> As described by the ROM study (see Table 1, below), the reverse prosthesis
may be
associated with a 16.7% to 18.9% increase in ROM (as compared to the
traditional
Grammont prosthesis).
D As described by the ROM study (see Table 1, below), the reverse prosthesis
may be
associated with a reduction in the incidence of scapular notching (i.e.
medial/inferior
impingement of humerus on scapula) as a result of the reduction in neck angle
from 155 tO
145 (as compared to the traditional Grammont design) and the increase in
humeral liner
size (since the liner may be brought out of the proximal humerus.
D The reverse prosthesis may maintain the low incidence of glenosphere
loosening by utilizing
the proven traditional Grammont-style glenosphere/screw/baseplate designs
(note: the
glenosphere design may be hollowed out to reduce weight).
D The glenoid plate may utilize a bone "through-growth" cage design to
enhance fixation.
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> The glenoid plate may allow for the insertion of a compression
screw (e.g., at up to 15
degrees of angular variability) in any of the 4 holes to maximize bone
purchase.
> The glenoid plate may allow the use of a locking cap screw which can
he attached to any
compression screw thereby making each screw a locking/compression screw.
> The humeral liner may be manufactured from Connection GXL (i.e. enhanced
poly) and
may utilize a "mushroom" apical-locking mechanism to attach the humeral liner
to the
humeral plate (see Figs. 10A-10C showing three views of such an example
humeral liner
and Figs. 11A-11B showing five views of such an example humeral plate) -
therefore, a low
incidence of humeral liner wear and disassociation may be expected.
= 44-
,4*e r...1#4; w4".11
101,6Malte! 0,143-440drttie-4.1P_Arisno,%1-'
*02,4tE,011.4%F:1,0:0)1=== If*: #..i.**Wea VOTati
. =
38/22mtn 145 0 312 0.893 0.323 inches 17 to 83 1129
135 16.7% 65
at 55 .Abd
42/24mm 145 0.300 0.944 0.334 inches 13 to 87. 116.6
136.9 17.8% 98
a 55' Abd
46/26mm 145 0.288 0.9I19 0.341 inclics 11 to 90 120.8
138.8' 189% 140
at 55 Abd
Gtammont 155 0.276 0.584 0.330 inchcs 35 to 95 90
112.5 NA 47
36/18mm at 65 Abd
Table 1¨ Reverse Shoulder ROM Comparison
Another embodiment of the present invention relates to a reverse shoulder
prosthesis and
method for implantation that incorporates many or all of the aforementioned
benefits associated
with the traditional Grammont reverse shoulder design while at the same time
minimizing the
number and rate of observed complications and to address other areas of
concern related to the
method of implantation. The historic benefits which may be incorporated
include (but are not
limited to): 1) lengthen/tension deltoid to improve muscle efficiency; 2)
maintain center of
= rotation on (or close to) the glenoid fossa to minimize the effective
moment arm; and/or 3) invert
the concavities of the natural joint to create a physical stop to prevent
humeral head superior
migration. The complications/concerns that are minimized include (but are not
limited to): 1)
reduce the incidence of impingement; 2) reduce the incidence of scapular
notching; 3) improve
stability; 4) decrease the incidence of dislocation; 5) improve glenoid
fixation; 6) conserve bone;
and/or 7) better facilitate a conversion of a hemi- or total shoulder to a
reverse shoulder. A =
detailed description of each design feature which may address the
aforementioned complications/
concerns is disclosed below.
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To reduce the incidence of impingement and scapular notching, the neck angle
of the
reverse shoulder component may be reduced from 155 (the neck angle of the
traditional
Grammont reverse prosthesis and essentially every subsequent reverse shoulder
prosthesis on the
market) to 145 . Testing has demonstrated (see Fig. 26) that a 10 reduction
in neck angle results
in a downward shift in range of motion (ROM),. ,this downward shift acts to
provide a ROM that
is more in alignment with a patient's activities of daily living (ADL).
Evidence of the need for a
downward shift in ROM was objectively demonstrated in a study by De Wilde (see
De Wilde, L.
et al. Shoulder Prosthesis Treating Cuff Tear Arthropathy: a comparative
biomechanical study.
JOR 22: 1222-1230. 2004) who used radiographic templates to demonstrate that
the traditional
Grammont design was associated with inferior impingement at 16 abduction.
Additional
evidence of this design flaw is documented in a study by Nyffeler (see
Nyffeler, R. et al.
Biomechanical Relevance of Glenoid Component Positioning in the Reverse Delta
III Total
Shoulder Prosthesis. JSES. Vol. 14, #5: 524-528. 2005) who compared the
incidence of scapular
notching at 4 different conditions: 1) when the glenosphere is centered on the
glenoid; 2) when
the glenoid is positioned at the inferior glenoid rim; 3) when the glenosphere
inferiorly
overhangs by 2-4mm; and 4) when the glenosphere is tilted inferiorly at 15
degrees and flush
with the scapular neck; as depicted in Figure 27. Nyffeler concluded that a
glenosphere with an
inferior overhang of 2-4mm was associated with significantly improved
abduction/adduction
ROM (as a result of the reduced inferior impingement).
It should be noted that glenosphere conditions 2-4 in the Nyffeler study are
believed to be
surgical modifications to the manufacturer-endorsed technique [condition 1] -
these
modifications are believed to be necessary to specifically address the
aforementioned design
flaw. There may be some benefit to positioning the glenosphere so that it
overhangs inferiorly;
however, it is believed that locating the glenosphere inferiorly may present a
number of new
concerns ¨ most notably in the presence of a central bone defect, as would be
common in the
conversion of a total shoulder to a reverse shoulder (to obtain inferior
glenosphere overhang with
typical reverse designs a hole would need to be drilled in the inferior
portion of the glenoid,
causing the removal of additional glenoid bone). In order to conserve this
much needed glenoid
bone, one embodiment of the present invention utilizes a glenoid plate so that
its central stem is
shifted superiorly by 4mm ¨ enabling the surgeon to maintain the traditional
surgical technique
with the reverse as would be performed for total shoulder arthroplasty (i.e.
drilling a hole in the
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center of the glenoid where the defect would occur; thereby, conserving bone).
From a technique
standpoint, a hole is drilled in the center of the glenoid, the glenoid bone
is reamed, and the
glenoid plate is inserted and secured with screws so that the inferior edge of
the plate would sit
flush on the inferior edge of the native glenoid bone. An added advantage of
the superiorly =
shifted stem is that the locking screw hole in the glenosphere will no longer
be positioned at the
apex of the glenosphere (a region which is commonly loaded) ¨ instead it will
be superiorly
shifted to a region that is not as commonly loaded (which corresponds to the
location of the
superiorly shifted stem on the glenoid plate).
To improve stability and decrease the incidence of dislocation, the humeral
liner may in
one embodiment be brought out of the proximal humerus so that the proximal
humerus is no
longer used to establish the size of glenosphere. This feature may be
advantageous for a number
of reasons (including, bit not limited to): 1) proximal humeral bone is
conserved since proximal
reaming is not required and 2) the glenosphere size can be established by the
size of the native
glenoid bone (rather than being established by the size of liner placed in the
proximal humerus) ¨
testing has demonstrated improved ROM and stability with an increasing
glenosphere diameter.
This feature also facilitates the conversion from a hemi- or total shoulder to
a reverse (or vice-
versa: the conversion of a reverse to a hemi- or total shoulder) since this
reverses design may
utilize the same humeral stem as that used for hemi- and total shoulder
arthroplasty (i.e. the
surgeon does not have to remove a well fixed humeral stem to convert to a
reverse shoulder). It
should be noted that this embodiment maintains the same humeral neck cut that
is utilized for a
henai- and/or total shoulder (i.e. the humeral head is reseeted at or about
the anatomic neck).
Other systems typically require a resection at a different location as that
utilized for hemi- and/or =
total shoulder arthroplasty.
An additional embodiment to reduce the incidence of dislocation involves the
use of a =
tension band that may connect the glenosphere and humeral components and may
be sized
according the length of the patient's deltoid. The band may break during trial
reduction at a
tension that corresponds to an appropriate lengthening of the deltoid to
achieve adequate stability
and function. Two studies by De Wilde (see De Wilde, L. et al. Shoulder
Prosthesis Treating
Cuff Tear Arthropathy: a comparative biomechanical study. JOR 22: 1222-1230.
2004; De
Wilde, L. et al. Functional Recovery after a Reverse Prosthesis for
Reconstruction of the
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Proximal Humerus in Tumor Surgery. CORR. #430: 156-162. 2005) suggest that a
10-20%
increase in deltoid length is appropriate.
In one example, the glenosphere and humeral size range is therefore increased
to 38-
= 46mm (relative to the size. range provided by competitive designs: 34-
42mm, which do not
utilize this technique). To achieve these large size glenospheres the anterior
and posterior sides
of the glenospheres may be chamfered; thereby, allowing them to be inserted
into the wound site
and sit flush on the resected surface without having to remove any excess
glenoid bone. The
internal geometry of each glenosphere may be hollowed out to reduce its
weight, doing so may
minimize the incidence of fatigue-induced bone fractures. To increase ROM and
improve
stability, each glenosphere may have an extended articular surface (i.e. an
arc larger than 180 -
see Fig. 32).
To improve glenoid fixation, the invention may utilize a bone "through-growth"
glenoid
plate stem which accepts the use of bone graft. Bone graft can be placed into
the stem prior to
securing the plate with screws and/or after (e.g., by injecting the graft
through a syringe in the
top of the plate). The bone through-growth fixation stem can be either
cylindrical (e.g., to revise
a peg glenoid) or non-cylindrical (e.g., to revise a keel glenoid). Modifying
the shape and profile
of the glenoid plate may also improve glenoid fixation; in one example the
inventors modified
the plate from the traditional Grammont-style circular design (utilized by
other conventional
designs on the market) to a pear/oval design (which more accurately reflects
the anatomy of the
scapula). Doing so may improve glenoid fixation by allowing for an increase in
the number of
glenoid screw holes available for fixation (e.g., an increase from 4 to 6) and
an improvement in
the position of the screw holes so that it maximizes the potential for
fixation (i.e. each screw hole
is located according the region of best quality/deepest bone). Figures 12-15
further elaborate on
= these advantages. More particularly: Figure 12 summarizes the results of
two different anatomic
studies (lannotti, J.P. et al. The Normal Glenohumeral Relationships. JRTS.
Vol. 74-A, #4: 491-
500. 1992; Checroun, A.J. et al. Fit of Current Glenoid Component Designs: an
Anatomic
Cadaver Study. JSES. Vol. 11, #6: 614-617. 2002); each of these studies
demonstrate that the
glenoid is wider inferiorly than superiorly and that it has a characteristic
pear or "inverted-
comma" shape. Figure 13 graphically illustrates the fit of a typical Grammont-
style glenoid plate
on a representative glenoid fossa; it is believed that the typical 4-quadrant
location of the screw
holes is not ideal due to the anterior and posterior slope of the scapula ¨
this slope results in a
CA 02916711 2016-01-05
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thin base of bone in these locations. Figure 14 graphically illustrates the
region of best
quality/deepest bone in the native glenoid. Finally, Figure 15 graphically
illustrates the rationale
for screw hole position utilized in an embodiment of the present invention.
The glenoid plate may also incorporate several other features which should
work to
conserve glenoid bone and/or improve fixation. The glenoid plate may have a
curved-back to
minimize the amount of bone removed for implantation, (compared to the flat-
back glenoid plate
designs, as the native glenoid bone is also curved). Additionally, one or more
screw holes in the
glenoid plate may have a female spherical feature which mates with the male
spherical head of
the compression screw. Doing so may allow for each compression screw to be
angled/oriented in
any desired direction ¨ thereby improving the possibility of screw purchase.
Additionally, one or
more of the screw holes in the glenoid plate may have a threaded feature for
attachment of a
locking cap ¨ this cap screw may have a female spherical feature which
compresses the spherical
head of the compression screw; thereby locking it to the plate at whatever
angle/orientation the
screw was inserted into thp bone (preventing it from backing out).
Various details of a reverse shoulder design according to an embodiment of the
present
invention are shown herein. Figures 16A-16D depict the assembled construct of
an example
reverse shoulder prosthesis. The components of this construct include a
humeral stem (which
may be used in pressfit and/or cemented applications and may be constructed
from titanium), a
humeral liner (a concave component which mates with the convex glenosphere;
may be
constructed from UHMVIPE), a humeral adapter plate (which connects the humeral
liner to the
humeral stem; may be constructed from titanium), a glenosphere (may be
constructed from
cobalt chrome), a glenoid plate (may be constructed from titanium), and a
number of screws and
fixations devices for assembly of the individual components to one another and
for assembly of
the construct to the native bone (all may be constructed from titanium).
Figures 17A-17D depict
an example glenoid plate design (several features should be noted: 1) the 6
screw holes on the .
backside of the plate, and 2) the bone "through-growth" cage stem which
enables bone graft to
be injected via syringe through the front of the plate and/or placed through
the hole in the bottom
surface of the cage stem). Figures 18A-18D and 5D-5F depict two other
embodiments of the
glenoid plate design (incorporating curved back glenoid plates). Figure 25
depicts an example
compression screw (note the spherical head which enables the screw to be
angularly oriented in
any desired direction).
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As discussed above, varies embodiments of the reverse shoulder design may
include (but
not be limited to): Superiorly shifted Glenoid Plate Stem; Non Cylindrical
Glenoid Plate Stem;
Oval/Pear Shaped Glenoid Plate to Improve Fixation; Non 155 Degree Humeral
Neck Angle;
Extended Articular Surface Glenosphere; and/or Tension Band to gage deltoid
tension; a bone
"through growth" cage may be applied for use in the reverse shoulder
prosthesis.
As described herein, one embodiment of the present invention relates to a
superiorly
shifted glenoid plate stem (see, e.g., Fig. 28 as well as other Figs. herein).
In this regard, an
inferiorly overhanging glenosphere is associated with less scapular notching
and a better clinical
result (based upon the clinical observations by Nyffeler ¨ third image from
left in Fig. 29 =
(modified image from Nyffeler study in which the clinical effectiveness of 4
different
Glenosphere positions were examined)). However, the positioning the
glenosphere inferiorly
may present a number of new concerns, mainly, in the presence of a central
bone defect as would
be common in the conversion of a total shoulder to a reverse shoulder (as a
result of the glenoid
being removed). To obtain inferior glenosphere overhang with other reverse
designs, a hole
would typically need to be drilled in the inferior portion of the glenoid,
causing the removal of
additional glenoid bone. In order to conserve this much needed glenoid bone, a
glenoid plate
according to one embodiment is designed so that its central stem is shifted
superiorly (e.g., by 4
mm)¨enabling the surgeon to maintain the traditional surgical technique with
the reverse as
would be performed for total shoulder arthroplasty (i.e. drilling a hole in
the center of the glenoid
where the defect would occur; thereby, conserving bone). Additionally, with
other glenoid plate
designs the inferior hole (which is typically angled inferiorly to allow for
insertion of a screw
along the inferior scapular neck) is typically no longer in the correct
position to allow the screw
to be inserted along the inferior scapular neck.
As further described herein, another embodiment of the present invention
relates to
glenoid plate hole positions that are designed to allow conversion of a
traditional peg and keel
glenoid. In the case of the revised peg glenoid, the central peg of the
glenoid plate of this
embodiment is designed to fill the central bone defect left by the removed
glenoid's central peg.
As depicted in Figs. 30A and 30B, the superior anterior/posterior set of screw
holes are
positioned at a location where no bone was removed in the revision of a pegged
glenoid; using =
these features, adequate fixation was achieved. The tilted inferior hole and
superior hole also
successfully contributed to fixation, particularly when the +100 angulation of
the compression
22
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screws were utilized. In the case of the revised keeled glenoid, the central
stem of the glenoid
plate of this embodiment is designed to partial fill the central bone defect
left by the removed
keeled glenoid; graft may be used to completely fill the defect ¨ which could
be, for example,
injected in the front (see below for additional discussion). As depicted in
Figs. 31A and 31B, the
two sets of anterior/posterior holes are positioned at a location where no
bone was removed in
the revision of the keeled glenoid; using these features, adequate fixation
was achieved. As in the
revision of a pegged glenoid, the tilted inferior hole and superior hole also
successfully
contributed to fixation, particularly when the 1100 angulation of the
compression screws were
utilized.
As further described herein, another embodiment of the present invention
relates to
anterior/posterior glenosphere flats (see, e.g., Fig. 32 as well as other
Figs. herein).
As further described herein, another embodiment of the present invention
relates to an
extended articular surface to improve ROM (i.e. greater than 180 degrees
articular surface - see,
e.g., Fig. 32 as well as other Figs. herein).
To improve stability and decrease the incidence of dislocation, the humeral
liner of this
embodiment was brought out of the proximal humerus (as is the case in the
traditional
Grammont design) so that the proximal humerus is no longer used to establish
the size of
glenosphere. This feature is advantageous for a number of reasons: 1) proximal
humeral bone is
conserved, since proximal reaming is not required and 2) glenosphere size can
be established
based upon the siz.f. of the native glenoid bone (rather than being
established by the size of liner
placed in the proximal humerus). Testing has demonstrated that improved ROM
and stability can
be achieved with a larger 'glenosphere diameter of this embodiment. This
feature also better
facilitates the conversion from a hemi- or total shoulder to a reverse (or
vice-versa: the
conversion of a reverse to a hemi- or total shoulder), because the reverse
design of this
embodiment utilizes the same humeral stem as that used for hemi- and total
shoulder arthroplasty
(i.e. the surgeon does not have to remove a well fixed humeral stem to convert
to a reverse
shoulder). It should be noted that this embodiment also maintains the same
humeral neck cut that
is utilized for a hemi- and/or total shoulder (i.e. the humeral head is
resected at or about the
anatomic neck). Other systems typically require a resection at a different
location as that utilized
for hemi- and/or total shoulder arthroplasty. Therefore, the glenosphere and
humeral liner size
range in this embodiment is increased to 38-46 mm (relative to the size range
provided by the
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other designs on the market of 3442 mm, which do not utilize this technique).
To achieve these
large glenosphere sizes, the anterior and posterior sides of the glenospheres
may be chamfered.
This allows the glenosphere to be inserted into the wound site and sit flush
on the resected
surface without having to remove any excess glenoid bone. In certain
conventional systems the
glenosphere is spherical, by chamfering the anterior and posterior sides of
the glenosphere the
inventors are able to make the shape of the glenosphere better resemble that
of the native glenoid
which is thinner in the anterior and posterior directions. Additionally,
adding an anterior and
posterior chamfer to the glenosphere under this embodiment has the added
benefit of making it
easier to insert since it allows it to more easily get by the humerus during
insertion of the device.
Regarding other features of the glenosphere under various embodiments of the
present -
invention, the internal geometry of each glenosphere may be hollowed out to
reduce its weight
= (and provide space for a locking cap). This may minimize the incidence of
fatigue-induced bone
fractures. Additionally, to increase ROM and improve stability, each
glenosphere may have an
extended articular surface (i.e, an are larger than 180 degrees ¨ see Fig.
32).
In another embodiment of the present invention an optimized combination of
humeral
neck angle, humeral liner constraint, glenosphere diameter, and glenosphere
thickness may be
used to maximize ROM and jump distance and limit scapular notching.
In another embodiment of the present invention a bone cage (cylindrical and/or
noncylindrical ¨ for example, to fill a bone defect in the revision of a
pegged and/or keeled
glenoid ¨ see, e.g., Figs_ 28 and 33, respectively) with a frontal opening to
allow bone through
growth and insertion of a therapeutic agent before and/or after implantation
in situ and/or
through the front in a revision case may be provided.
In another embodiment, a method of reconstructing a diseased shoulder is
provided,
comprising: providing a glenosphere, a glenoid plate and a humeral liner which
interact to achieve a
range of motion of a desired number of degrees (e.g., in at least a generally
superior-inferior
direction).
As discussed herein, various embodiments of the present invention provide an
anatomic
design of a glenoid plate which enhances stress transfer to the glenoid fossa
and limits prosthesis
A/P overhang. Additionally, the anatomic shaped glenoid plate may optimize the
number of screw
holes that can be used for fixation while at the same time maximizing their
location relative to the
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best quality/deepest bone available in the native glenoid. Moreover, one or
more compression
screws may be utilized as locking screws by using a locking cap screw.
Reference will now be made to a study to evaluate the relationships between
the design
parameters associated with the typical Grammont reverse shoulder design and
the commonly
reported clinical complications. The results of this study may be used to
identify and establish
design inputs used for a reverse shoulder prosthesis according to various
embodiments of the
=
present invention.
For the purposes of this discussion, the following definitions may apply:
Range of Motion
(ROM) is defined as the humeral rotation occurring between inferior and
superior impingement,
wherein inferior and superior impingement are defined as the point where the
liner extends past the
glenosphere (see Fig. 34). It should be noted that rotation of the scapula was
not considered in this
measurement; only humeral motion was considered to enable a one-to-one
comparison between
designs. Therefore, the presented ROM values are not intended to correspond
with clinically
reported values. Jump Distance is defined as the lateral distance necessary
for the glenosphere to
escape from the humeral liner; it is a measure of the resistance to
dislocation (assuming no
impingement) (see Fig. 35). Offset is defined as the vertical distance between
the center of the
humeral liner and glenosphere; it is related to deltoid tensioning (see Fig,
36). Humeral Constraint
is defined as the ratio between humeral liner depth and width (at its face).
For clarification, a
constraint > 0.5 is a constrained joint (see Fig. 37).
Under the study, a typical 36mm Grammont reverse shoulder prosthesis (Depuy,
Ine./Tomier Inc.) was obtained and reverse engineered using an optical
comparator and calipers.
The prosthesis was then geometrically modeled (in a parametric fashion
¨thereby allowing the
design parameters to be varied) using Unigraphics (UGS, Inc.) based upon the
elucidated design
parameters. A ROM simulation was constructed (also using Unigraphics) to
simulate humeral
abduction/adduction and quantify the aforementioned study parameters.
The subject typical Grammont reverse shoulder was geometrically modeled using
three
dimensional (3-D) computer-aided design software (Unigraphics; UGS, Inc.). An
assembly analysis
was conducted to quantify the effect of several prosthetic design parameters
(humeral neck angle,
humeral liner constraint, glenosphere thickness, and glenosphere diameter) on
several functionally
relevant measurements (ROM, jump distance, and offset) during simulated
humeral
abduction/adduction. By implication, the relationship between the
aforementioned design
CA 02916711 2016-01-05
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parameters and functional measurements will elucidate the failure mechanisms
associated with the
commonly reported clinical complications for reverse shoulder arthroplasty
(scapular notching,
dislocation, improper deltoid tensioning, etc...). Specifically, ROM, jump
distance, and offset were
quantified and compared for each of the following design conditions: as
humeral neck angle varied
from 130 to 165 (in 5' increments); as humeral constraint varied from 0.250
to 0.3125 (in 0.0125
increments); as glenosphere thickness varied from 17 to 21 nun (in lmm
increments); and as
glenosphere diameter varied from 34 to 44 mm (in 2mm increments).
Under this study the typical Granunont reverse shoulder (i.e. 155 neck angle,
humeral
=
constraint of 0.275, 36x19mm Glenosphere) was observed to impinge
inferiorly and superiorly at =
350 and 950 abduction, respectively. (see Fig. 38) .
Increasing the humeral neck angle by 50 positively shifts the ROM by 5 by
changing the =
points of impingement. Additionally, increasing the humeral neck angle by 5
also increases the
offset from 0.25 to 0.5mmi depending upon the angle of abduction. For
clarification, the Nyffeler
study reported that implanting a glenosphere with a 15 inferior tilt was
associated with a decrease
in scapular notching. Figs. 39 and 40 illustrate why removing 15 from the
glenosphere is
functionally the same thing as removing 15 from the humeral neck angle. Both
minimize inferior
impingement; the only difference being in the later, glenoid bone is
conserved.
Increasing the humeral constraint by 0.0125 decreases the ROM by 4 ; more
constraint, less
motion (see Fig. 41). Similarly, increasing the humeral constraint by the same
amount also increases
the jump distance by 0.5mm; more constraint, greater resistance to
dislocation.
Increasing glenosphere thickness by lmm (when humeral constraint is constant)
increases
the ROM by 5 . Offset and Jump Distance are not affected (see Fig. 42).
Increasing glenosphere diameter by 2mm (when humeral constraint is constant)
increases
the jump distance by 0.5mm_ ROM is not affected (see Fig. 43).
The results of this study demonstrate the relationship between each design
parameter and
functional measurement Furthermore, the results demonstrate the typical
Grammont design
inferiorly impinges on the scapula prior to the patient being able to adduct
his/her arm to their side,
which is required for many activities of daily living. These results are
validated by those presented
in the literature from both radiographic and clinical studies (see Fig. 44;
see also, Nyffeler, R.W. et
al. Biomechanical Relevance of Glenoid Component Positioning in the Reverse
Delta III Total
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Shoulder Prosthesis. JSES. Vol. 14. #5; 524-528. 2005; De Wilde, L.F. et al.
Shoulder Prostheses
Treating Cuff Tear Arthropathy: a comparative biomechanical study. JOR. #22:
1222-1230. 2004).
Based upon these observations, the conclusion is that the specific combination
of humeral
neck angle, glenosphere geometry, and humeral liner geometry are interrelated
but not necessarily
optimized in the traditional Grammont design ¨ and thus make it susceptible to
scapular notching
and dislocation via inferior impingement. The knowledge of these relationships
can serve as the
basis for optimizing a traditional Grammont-style reverse shoulder prosthesis
according to various
embodiment of the present invention.
=
In this regard, various embodiments of the present invention may provide a
reverse shoulder
design shifting the inferior impingement point to a location that permits a
ROM better
accommodating a patient's activities of daily living. The application of these
relationships is useful
in the design of a reverse shoulder prosthesis that maximizes ROM and jump
distance, minimizes
impingement, and provides sufficient offset to tension the deltoid and
maintain certain
= biomechanical benefits associated with the traditional Grammont reverse
shoulder design.
Reference will now be made to another study to: 1) quantify the range of
motion and jump
distance associated with an Equinoxe reverse shoulder design during simulated
humeral
abduction/adduction as determined using a three-dimensional computer aided
assembly analysis;
and 2) compare these parameters to those associated with the typical Grammont
reverse shoulder
design during the same simulated motion, quantified using the same
methodology. The results of the
comparison verify that the Equinoxe reverse shoulder achieves an increase in
the amount of motion
and a decrease in the amount of inferior impingement (a measure of motion and
stability, indicative
of scapular notching) while maintaining a similar amount ofjump distance (a
measure of stability,
indicative of the probability of dislocation), relative to the typical
Grammont design.
The Equinoxe reverse shoulder that is the subject of this study was designed
based upon
the principles elucidated and described in connection with the study described
above. Some
design goals of this prosthesis are described below (some the design specifics
of each component
= are shown in Figs. 45-53):
=
1) Maintain the Biomechanical Benefits of the typical Grammont Reverse Design:
Prevent
Superior Humeral Migration, Minimize Lever Arm by Placing Center of Rotation
on
Glenoid Fossa (by moving it medially and distally), Elongate Deltoid by ¨15%.
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2) Minimize Scapular Notching/Inferior Bone Impingement
3) Improve Range of Motion
4) Maximize Jump Distance
5) Seamlessly Integrate Equinoxe Primary System with a Reverse Option (i.e.
utilize the
same humeral stem)
As described below, this study demonstrates that the Equinoxe reverse shoulder
achieves
an increase in the amount of motion and a decrease in the amount of inferior
impingement (a
measure of motion and stability, indicative of scapular notching) while
maintaining a similar
amount of jump distance (a measure of stability, indicative of the probability
of dislocation),
relative to the typical.36mm Crrammont design.
For the purposes of this study, the aforementioned prostheses were designed
and
geometrically modeled by using Unigraphics (UGS, Inc.), based upon the
elucidated design
parameters described in the study discussed above. A ROM simulation was
constructed (also
using Unigraphics) to simulate humeral abduction/adduction and quantify the
aforementioned
study parameters.
The same methodology described in the study discussed above was applied to
quantify
the points of inferior and superior impingement, the total ROM, and the jump
distance at 3 -
increments during simulated humeral abduction/adduction of the Equinoxe
reverse shoulder
prosthesis. It should be noted that the definitions used in this study for
inferior and superior
impingement are slightly different than those used in the study discussed
above due to the
differences in design. As shown in Figures 45 and 46, the Equinoxe reverse
shoulder glenoid
plate has a central stem that is superiorly shifted by 4mm; doing so, results
in a 4mm distal shift
to the glenosphere assuming that the central stem of the glenoid plate is
implanted so that the
distal rim of the glenoid plate aligns with the distal edge of the glenoid
articular surface. A 4mm
distal shift of the glenosphere creates an inferior overhang that has been
demonstrated by
Nyffeler to be associated with superior clinical results, compared to
alternative glenosphere
implantation techniques. For this reason the defined points of inferior and
superior impingement
are modified as depicted in Figures 54 and 55, respectively.
During simulated humeral abduction/adduction, inferior and superior
impingement was
measured to occur for the 38mm, 42mm, and 46mm Equinoxe reverse shoulder at 16
and 91.5 .;
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7.5 and 91.5'; and 0 and 91.5 , respectively. Therefore, the total ROM
during simulated
humeral abduction/adduction for the 38mm, 42mm, and 46mm Equinoxe reverse
shoulder was .
measured to be 75.5 , 84 , 91.5 , respectively. For clarification, Figure 56
depicts several defined
angles during this simulated motion for the 42mm Equinoxe reverse shoulder of
this example.
Over this ROM, the minimum and maximum jump distance associated with the 38mm,
42mm, and 46mm Equinoxe reverse shoulder was measured to be 0.035in ¨ 0.855in;
0.035in ¨
1.052in; and 0.035in ¨ 1.234 in, respectively. The average jump distance (in 3
increments over
the aforementioned ROM) associated with the 38mm, 42mm, and 46mm Equinoxe
reverse
shoulder was measured to be 0.371in, 0.458in, and 0.522in, respectively.
By comparison, the typical 36mrn Grammont reverse shoulder inferiorly and
superiorly
impinged at 35 and 95 , providing a total ROM of 60 . The minimum and maximum
jump
distance for this ROM was measured to be 0.081 ¨ 0.749 inches; having an
average jump
distance of 0.374in over this ROM (in 3 increments). As depicted in Figures
57 and 58, the
Equinoxe reverse shoulder of this example is associated with a 20.5%, 28.6%,
and 34.4% greater
ROM and a-0.8%, a 18.3%, 28.3% greater average jump distance than the typical
Grammont
reverse shoulder prosthesis.
The results of this design verification demonstrate that the Equinoxe reverse
shoulder
prosthesis of this example is associated with more motion, less impingement,
and a similar
amount of stability as the typical 36nam Grammont design.
Regarding this conclusion, three points should be considered. First, the ROM
values
obtained in this study are less than those reported clinically. The reason for
this discrepancy is
due at least in part to scapular motion not being considered in the analysis,
only humeral motion
was considered. The ratio of scapular motion to humeral motion has been
reported between 0.4 -
0.7; depending upon the condition of the rotator cuff: the larger the cuff
tear the greater the
amount of scapular motion relative to humeral motion (see, De Wilde, L.F. et
al. Functional
Recovery after a Reverse Prosthesis for Reconstruction of the Proximal Humerus
in Tumor
Surgery. CORK #430: 156-162. 2005; Mell, A.G. et al. Effect of Rotator Cuff
Tear Size on
Shoulder Kinematics. Transactions of the 51st Annual Meeting of the
Orthopaedic Research
Society. Poster #0623. 2005). Therefore, for cuff tear arthropathy, the most
common indication
for reverse shoulder arthroplasty, it is reasonable to assume that the amount
of scapular motion
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relative to humeral motion is on the high end of this ratio ¨ when this is
considered, the results of
this study comply with the clinical ROM data published in the literature.
Second, the average jump distance for the 38mm Equinoxe reverse shoulder
design of
this example was 0.371 inches; this value is 0.003 inches (i.e. 0.075mm) less
than that of the
typical 36mm Grammont (0.374 inches). However, it is believed that this minute
difference falls
within the allowable manufacturing tolerances of either part and is also
probably negligible when
the accuracy and precision of the test methodology is considered. For this
reason, it was
concluded that these two designs have similar jump distances and therefore
similar levels of
stability.
Third, only the typical 36mm Grammont design was considered, both Depuy and
Tornier
provide a 42mm glenosphere. However, it is believed that the 42mm prosthesis
is rarely used
clinically because the Grammont surgical technique typically requires reaming
of the proximal
humerus and 90%-95% of the time the proximal humerus is too small to accept a
42mm humeral
liner. Dr. Walch presented that the 42mm glenosphere is used in <5% of his
reverse arthroplasty
cases at the 2005 American and Shoulder Elbow Society meeting in Orlando.
Depuy in its Delta
III marketing literature reported that the 42mm glenosphere was used in only
11% of cases in
2004. Because the Equinoxe reverse shoulder of this example does not require
reaming of the
proximal humerus, (e.g. it is implanted using a traditional humeral head
osteotomy along the
anatomic neck of the humerus) it is possible to implant a larger diameter
glenosphere. In this
way, the size of the glenosphere used is determined based upon the size of
glenoid, rather than
the size of the proximal humerus. That being said, Figure 58 approximated the
ROM that would
be associated with the 42Mm glenosphere design assuming the 42mm humeral liner
constraint
was the same as that of the 36mm humeral liner constraint. If this assumption
is valid, then the
same percentage increases in ROM of the Equinoxe reverse shoulder of this
example over the
typical 36mm Grammont design would also apply for the typical 42mm Grammont
design.
For all these reasons, the results of this study have demonstrated that the
Equinoxe =
reverse shoulder prosthesis of this example is associated with more motion,
less impingement,
and a similar amount of stability as the typical 36mm Grammont design.
While a number of embodiments of the present invention have been described, it
is
understood that these 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
=
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described herein may be provided in any desired size (e.g., any element
described herein may be
provided in any desired custom size or any element described herein may be
provided in any desired
size selected from a "family" of sizes, such as small, medium, large).
Further, one or more of the =
components may be made from any of the following materials: (a) any
biocompatible material
(which biocompatible material may be treated to permit surface bone ingrowth
or prohibit surface
bone ingrowth ¨ depending upon the desire of the surgeon); (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-6A1-4V, stainless
steel); (f) any combination thereof. Further still, the metal construct may be
a machined metal
construct. Further still, various cage designs (e.g. square/elliptical/angled
cages) may be utilized.
Further still, various keel designs (e.g, anterior/posterior keel,
mediaUlateral keel, dorsal fm keel,
angled keel) may be utilized. Further still, the prosthesis may utilize one or
more modular elements.
Further still, any desired number of cages(s) and/or keel(s) may be utilized
with a given prosthesis.
Further still, any number of protrusions (e.g., such as for initial fixation
by forming a bond with
cement and/or such as for supplemental fixation by forming a bond with cement)
may be utilized
with a given prosthesis. Further still, any number of female features that
increase the cement mantle
may be utilized with a given prosthesis. Further still, any number of male
features that could dig
into the bone so that initial/supplemental fixation can be improved may be
utilized with a given
prosthesis. Further still, any number of bone screws (e.g., such as for
initial fixation and/or such as
for supplemental fixation) may be utilized with a given prosthesis. Further
still, any steps described
herein may be carried out in any desired order (and any additional steps may
be added as desired
and/or any steps may be deleted as desired).
=
31
