U.S. patent application number 15/426720 was filed with the patent office on 2017-09-28 for bone graft shaper & patient specific bone graft.
The applicant listed for this patent is Tornier SAS. Invention is credited to Pascal Boileau, Pierric Deransart, Cedric Leon, Nicolas Neichel, Matthieu Jean Marie Vennin, Gilles Walch.
Application Number | 20170273795 15/426720 |
Document ID | / |
Family ID | 55640658 |
Filed Date | 2017-09-28 |
United States Patent
Application |
20170273795 |
Kind Code |
A1 |
Neichel; Nicolas ; et
al. |
September 28, 2017 |
BONE GRAFT SHAPER & PATIENT SPECIFIC BONE GRAFT
Abstract
Joint prosthesis methods and apparatuses are provided. A bone
graft blank is placed in the chamber of the bone press facing a
contoured surface. The contoured surface can be part of the bone
press or can comprise a surface of a patient specific negative that
can be inserted into the bone press. A bone contact surface of the
bone graft blank is disposed in the chamber to face the contoured
surface of the patient specific insert negative. The bone contact
surface of the bone graft blank is compressed against the contoured
surface. The bone contact surface can be reshaped to form a patient
specific bone graft.
Inventors: |
Neichel; Nicolas; (Le Sappey
En Chartreuse, FR) ; Vennin; Matthieu Jean Marie;
(Grenoble, FR) ; Leon; Cedric; (Saint-Ismier,
FR) ; Walch; Gilles; (Lyon, FR) ; Deransart;
Pierric; (Saint Martin d'uriage, FR) ; Boileau;
Pascal; (Nice, FR) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Tornier SAS |
Montbonnot-Saint Martin |
|
FR |
|
|
Family ID: |
55640658 |
Appl. No.: |
15/426720 |
Filed: |
February 7, 2017 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/4059 20130101;
A61F 2002/4085 20130101; A61F 2/28 20130101; A61F 2/4644 20130101;
A61F 2002/30948 20130101; A61F 2/30734 20130101; A61F 2002/30736
20130101; A61F 2/4081 20130101; A61F 2002/2835 20130101; A61F
2/30942 20130101; A61F 2002/30957 20130101 |
International
Class: |
A61F 2/30 20060101
A61F002/30; A61F 2/40 20060101 A61F002/40 |
Foreign Application Data
Date |
Code |
Application Number |
Mar 25, 2016 |
EP |
16305351.5 |
Claims
1. A method of forming a joint prosthesis component, comprising:
placing a prosthesis component in a chamber of a bone press, the
prosthesis component having a medial side and a lateral second
side; placing a bone graft blank in the chamber of the bone press
between a contoured surface of a patient specific insert negative
and the medial side of the prosthesis component, such that a bone
contact surface of the bone graft blank is facing the contoured
surface of the patient specific insert negative; and compressing
the bone contact surface of the bone graft blank against the
contoured surface of the patient specific insert negative;
reshaping the bone contact surface, thereby forming a patient
specific bone graft.
2. The method of claims 1, further comprising obtaining the bone
graft blank from a bone of a patient for whom the patient specific
bone graft is to be implanted.
3. The method of claim 1, further comprising obtaining the three
dimensional spatial location information
4. The of claim 3, wherein obtaining the three dimensional spatial
location information comprises performing a CT scan of a bone
surface forming a portion of a joint to be coupled with the patient
specific bone graft.
5. The method of claim 4, further comprising forming the patient
specific insert negative based upon the three dimensional spatial
location information.
6. The method of claim 1, wherein the prosthesis component
comprises a baseplate of a shoulder implant and further comprising:
placing the bone graft blank on the medial side of the glenoid
baseplate and placing the bone graft blank and the glenoid
baseplate into the bone press such that the bone contacting surface
of the bone graft blank faces the contoured surface of the patient
specific insert negative; and compressing the bone graft blank
between the glenoid baseplate and the contoured surface of the
patient specific insert negative; and reshaping the bone contact
surface to match a lateral portion of a scapula.
7. The method of claim 6 further comprising: mounting the baseplate
onto an impacting plate of an impactor and placing the bone graft
blank onto the impactor such that the baseplate is between the bone
graft blank and the impacting plate; and placing the impacting
plate, the baseplate, and the bone graft blank into the chamber of
the bone press such that the bone contact surface of the bone graft
blank faces the contoured surface of the patient specific insert
negative.
8. The method of claim 1, further comprising: mounting the
prosthesis component onto an impacting plate of an impactor and
placing the bone graft blank onto the impactor such that the
prosthesis component is between the bone graft blank and the
impacting plate; placing the impacting plate, the prosthesis
component, and the bone graft blank into the chamber of the bone
press such that the bone contact surface of the bone graft blank
faces the contoured surface of the patient specific insert
negative; and compressing the bone graft blank between the
prosthesis component and the contoured surface of the patient
specific insert negative; and reshaping the bone contact surface to
match a bone portion to which the patient specific bone graft is to
be coupled.
9. The method of claims 1, further comprising threading a first
portion of the bone press on a second portion of the bone press to
compress and reshape the bone graft blank between the prosthesis
component and the contoured surface of the patient specific insert
negative.
10. The method of claims 1, further comprising actuating a lever to
move a first portion of the bone press toward a second portion of
the bone press to compress and reshape the bone graft blank between
the first prosthesis component and the contoured surface of the
patient specific insert negative.
11. A method of forming a bone press component, comprising:
obtaining three dimensional spatial location information of a bone
portion of a joint; and forming a patient specific insert negative
comprising a contoured surface based on the three dimensional
spatial location information, the patient specific insert negative
being configured to be mounted on a bone press and to shape a bone
graft blank upon application of pressure in the bone press.
12. The method of claim 11, wherein the three dimensional spatial
location information comprises a three dimensional contour of a
lateral portion of a scapula including at least a portion of a
glenoid surface.
13. The method of claim 12, wherein obtaining three dimensional
spatial location information comprises performing a CT scan of the
glenoid surface or portion of the scapula.
14. A method of forming a patient specific bone graft comprising:
providing a bone press comprising a patient specific insert
negative disposed in a pressing zone thereof, the patient specific
insert negative comprising a contoured surface based on three
dimensional spatial location information of a bone portion to which
the patient specific bone graft is to be coupled; placing a bone
graft blank into the pressing zone; and compressing the bone graft
blank against the contoured surface of the patient specific insert
negative to cause a bone contacting surface of the bone graft blank
to conform to the contoured surface of the patent specific insert
negative, thereby forming a patient specific bone graft.
15. The method of claim 14, wherein the pressing zone is enclosed
by a cover configured to oppose forces applied by the patient
specific insert negative to the bone graft blank.
16. The method of claim 15, further comprising removing the cover
and placing the bone graft blank into the pressing zone and
thereafter replacing the cover
17. The method of claim 16, further comprising placing a prosthesis
component between the cover and the bone graft blank and, after
compressing the bone graft blank, removing the prosthesis component
and the patient specific bone graft from the pressing zone.
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Description
INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS
[0001] Any and all applications for which a foreign or domestic
priority claim is identified in the Application Data Sheet as filed
with the present application are hereby incorporated by reference
under 37 C.F.R. .sctn.1.57.
BACKGROUND OF THE INVENTION
Field of the Invention
[0002] This application is directed to patient specific methods and
devices useful in shoulder arthroplasty and other joint and
orthopedic surgery.
Description of the Related Art
[0003] Arthroplasty is the standard of care for the treatment of
advanced shoulder joint problems, such as severe arthritis.
Shoulder arthroplasty can replicate the anatomical form of a joint,
with a spherical component mounted on the proximal humerus and a
concave surface mounted on the glenoid region of the scapula.
Certain patients benefit from a reverse shoulder reconstruction in
which a spherical component is mounted to the scapula and a concave
surface is positioned on the proximal humerus. Articulation of the
spherical component on the concave surface provides the patient
with improved arm motion.
[0004] One leading reverse shoulder technique, known as bony
increased offset reverse shoulder arthroplasty or BIO-RSA provides
improved outcomes for patients. BIO-RSA involves placing a spacer
between the glenoid region of the scapula and a spherical joint
component that is coupled with the glenoid. Among other benefits,
BIO-RSA can improve range of motion, limit notching of the scapula,
and correct bone deficiency.
[0005] Surgeons currently use standard spacers in BIO-RSA, for
example with medial and lateral surfaces parallel to each other,
disposed at a 12.5 degree angle relative to each other, and with
limited options for thickness, such as 7 mm or 10 mm. In cases
where the glenoid region surface is worn and may have missing bone
portions a spacer with a flat surface will not seat properly
against the glenoid and early loosening of the implant can result
from improper seating. Further, in cases where the glenoid region
surface is worn and may have missing bone portions excessive
reaming of the bone may be needed to establish a flat surface on
which a spacer can be seated. However excessive reaming of the
glenoid surface can remove the dense subchondral bone and expose
the soft and porous cancellous bone which is a poor seating surface
for the spacer. Early loosening of the implant can be a consequence
of excessive reaming. What is needed is a spacer than can conform
to the worn glenoid surface without excessive reaming of the
scapula.
SUMMARY OF THE INVENTION
[0006] A great improvement in BIO-RSA and other procedures that
would benefit from adjusting lateral position of a component on a
scapula would result if methods and systems could form and employ
patient specific spacers. Patient specific spacers would better
adapt to patient joint surface shape, for example at or around the
glenoid surface of the scapula. Patient specific spacers can be
formed anticipating that some reaming may occur, but that the
glenoid will not be altered as extensively as in a conventional
procedure. Patient specific spacers can be formed based on
information about the condition and/or the shape of the joint
surface of the patient to be augmented by a spacer. The patient
information can be collected by a CT scan or by any other surface
characterization technology. Thereafter, the patient information
can be used as an input to shape a spacer from a bone graft
material. The system and method can be used to shape any one or
more of a section of bone from a proximal portion of the humerus,
an allograft, a synthetic bone, or another structure. In a
preferred embodiment the spacer is formed from a unitary piece of
bone. The system and method can be used to form a plurality of
pieces of bone or synthetic bone stock into a solid, unitary
patient specific spacer.
[0007] In one embodiment a joint prosthesis method is provided. A
first prosthesis component is placed in a chamber of a bone press.
The first prosthesis component has a first side, e.g., a medial
side, and a second side, e.g., a lateral side, oriented away from
the first side, e.g., the medial side. A bone graft blank is placed
in the chamber of the bone press between a contoured surface of a
patient specific insert negative and the first prosthesis
component. A bone contact surface of the bone graft blank faces,
e.g., is in contact with, the contoured surface of the patient
specific insert negative when so placed. The bone contact surface
of the bone graft blank is compressed against the contoured surface
of the patient specific insert negative. The bone contact surface
is reshaped to form a patient specific bone graft.
[0008] In a variation of the foregoing method, three dimensional
spatial location information of a lateral portion of a bone is
obtained. The contoured surface of the patient specific insert
negative is formed based on the three dimensional spatial location
information. The three dimensional spatial location information can
be information of or from a scapula, e.g., including information of
or from at least a portion of a glenoid surface.
[0009] In a variation of the foregoing methods, the first (e.g.,
medial) side of the first prosthesis component can be a side
oriented toward a glenoid of a shoulder joint when applied and the
second (e.g., lateral) side can be oriented toward a second
prosthesis component coupled with the humerus. In an elbow method,
the first prosthesis component can comprise a portion of a distal
humeral component of a prosthetic elbow joint and the second side
can face a bone such as a resected humerus Likewise, if the second
side faces a second joint component, the first side could face a
bone such as resected, reamed or otherwise prepared radius and/or
unla of the patient.
[0010] In another embodiment, a joint prosthesis method is
provided. A prosthesis component is placed in a chamber of a bone
press. The prosthesis component has a first side, e.g., a medial
side, and a second side, e.g., a lateral side. The first side is
configured to be orientated toward the patient, e.g., toward a
glenoid. The second side configured to articulate with another
prosthesis component when implanted, e.g., with a humeral
component. A bone graft blank is placed in the chamber of the bone
press between a contoured surface and the prosthesis component. The
contoured surface can be part of the bone press or can comprise a
surface of a patient specific negative that can be inserted into
the bone press. A bone contact surface of the bone graft blank is
disposed in the chamber to face, e.g., to be in contact with, the
contoured surface of the patient specific insert negative. The bone
contact surface of the bone graft blank is compressed against a
surface in the bone press, e.g., against the contoured surface of
the insert negative. The bone contact surface is reshaped to form a
patient specific bone graft.
[0011] In another embodiment a method of forming a bone press
component is provided. Three dimensional spatial location
information of a bone portion of a joint is obtained. A patient
specific insert negative is formed. The patient specific insert
negative has a contoured surface that is based on the three
dimensional spatial location information. The patient specific
insert negative is configured to be mounted on a bone press and to
shape a bone graft blank upon application of pressure in the bone
press.
[0012] In the method described in the preceding paragraph, the
joint can be a shoulder joint and the contoured surface can match,
replicate or otherwise correspond to a surface of the glenoid. The
surface to which the contoured surface is matched, replicates or to
which the surface otherwise corresponds can be that of the glenoid
before or after a bone preparation process such as reaming,
drilling or cutting. In other variations, the joint can be an elbow
joint and the contoured surface can match, replicate or otherwise
correspond to a surface of the humerus. The surface to which the
contoured surface is matched, replicates or to which the surface
otherwise corresponds can be that of the humerus before or after a
bone preparation process such as reaming, drilling or cutting.
[0013] In another embodiment a method of forming a patient specific
bone graft is provided. A bone press is provided that has a patient
specific insert negative disposed in a pressing zone thereof. The
patient specific insert negative has a contoured surface that is
based on three dimensional spatial location information of a bone
portion to which the patient specific bone graft is to be coupled.
A bone graft blank is placed into the pressing zone. The bone graft
blank is compressed against the contoured surface of the patient
specific insert negative. The compression causes a bone contacting
surface of the bone graft blank to conform to the contoured surface
of the patent specific insert negative. A patient specific bone
graft is thereby formed.
[0014] In another embodiment, a bone press is provided. The bone
press includes a base, a compression plate, and a housing. The
compression plate is disposed opposite of the base. The housing is
configured to extend between the base and the compression plate.
The housing extends along a longitudinal axis of the bone press
when so placed. A pressing zone is disposed within the housing and
between the base and the compression plate along the longitudinal
axis of the bone press. An actuator provides relative movement
between the compression plate and the base to create compression in
the pressing zone.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] Various embodiments are depicted in the accompanying
drawings for illustrative purposes, and should in no way be
interpreted as limiting the scope of the embodiments. Furthermore,
various features of different disclosed embodiments can be combined
to form additional embodiments, which are part of this
disclosure.
[0016] FIG. 1 is a partial cross-section of a shoulder joint,
including portions of a scapula and a humerus as well as a reverse
shoulder joint prosthesis components coupled therewith;
[0017] FIG. 1A is a partial cross-section of a scapula having a
glenoid component of an anatomical shoulder joint prosthesis
coupled therewith;
[0018] FIG. 2 illustrates a method of forming a patient specific
insert negative, which can be used in a bone press, based on
spatial location information;
[0019] FIG. 3 illustrates a method of forming a patient specific
bone graft, the graft being adapted for use in a joint replacement
or repair procedure;
[0020] FIG. 4 illustrates another method of forming a patient
specific bone graft, the graft being adapted for use in a joint
replacement or repair procedure;
[0021] FIG. 5 is a perspective view of one embodiment of a bone
press;
[0022] FIGS. 6 and 6A are cross-sectional view of two embodiments
of the bone press of FIG. 5 taken at section plane 6-6;
[0023] FIG. 7(A) is a partial exploded view of the bone press of
FIG. 5, with a bone graft blank, and a glenoid baseplate removed
from the bone press;
[0024] FIG. 7(B) is a partial exploded view of the bone press of
FIG. 5, with the glenoid baseplate and the bone graft blank
disposed on a base of the bone press;
[0025] FIG. 7(C) is a partial exploded view of the bone press of
FIG. 5, with a housing of the bone press disposed over and around
the glenoid baseplate and the bone graft blank;
[0026] FIG. 7(D) is an assembled view of the bone press of FIG. 5,
with a patient specific insert negative disposed on the bone graft
blank and at least partially within a pressing zone of the bone
press;
[0027] FIG. 7(E) is an assembled view of the bone press of FIG. 5 ,
with an actuator engaged with the patient specific insert negative
prior to compressing the bone graft blank in the pressing zone;
[0028] FIG. 7(F) shows a patient specific bone graft that can be
formed in the bone press of FIG. 5;
[0029] FIG. 8(A) shows a perspective view of a first embodiment of
a patient specific insert negative;
[0030] FIG. 8(A)-1 is a bottom view of the patient specific insert
negative shown in FIG. 8(A);
[0031] FIG. 8(B) shows a perspective view of a second embodiment of
a patient specific insert negative;
[0032] FIG. 9 is a perspective view of a second embodiment of a
bone press in which an end of a baseplate impactor is disposed in a
pressing zone of the bone press during the formation of the patient
specific bone graft and in which compression being applied in the
pressing zone by actuating a threaded coupling;
[0033] FIG. 10 is a cross-section of the bone press of FIG. 9 taken
along the plane 10-10;
[0034] FIG. 11(A) is a partial exploded view of an impactor, a
joint prosthesis component, and a bone graft blank that can be
placed in a bone press to form a patient specific bone graft on the
impactor;
[0035] FIG. 11(B) is a partial exploded view similar to that of
FIG. 11(A) showing the joint prosthesis component mounted on the
impactor;
[0036] FIG. 11(C) is a partial exploded view of the bone press of
FIG. 10 showing an end of an impactor, a joint prosthesis
component, and a bone graft blank disposed on a surface of a
structure partially forming a pressing zone;
[0037] FIG. 11(D) is a partial exploded view similar to that of
FIG. 11(C) showing a compression member placed on a lower shell of
a base of the bone press, the lower shell partially forming a
housing disposed around the pressing zone;
[0038] FIG. 11(E) is a partial exploded view similar to FIG. 11(C)
showing an upper shell placed over the lower shell to form a
housing disposed around the pressing zone;
[0039] FIG. 12 is a perspective view of a third embodiment of a
bone press in which a non-threaded actuator, e.g., a lever, applies
compression in a pressing zone during the formation of a patient
specific bone graft;
[0040] FIG. 13 is partial cross-sectional view of the bone press of
FIG. 12 taken along section plane 13-13;
[0041] FIG. 14(A) is a partial exploded view of the bone press of
FIG. 12 with an impactor, a joint prosthesis component, and a bone
graft blank received in and on a base thereof; and
[0042] FIG. 14(B) is an assembled view prior to actuation of a
lever to apply compression in the pressing zone, with a housing
disposed around the bone graft blank and the patient specific
insert negative coupled with a compression plate.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0043] While the present description sets forth specific details of
various embodiments, it will be appreciated that the description is
illustrative only and should not be construed in any way as
limiting. Furthermore, various applications of such embodiments and
modifications thereto, which may occur to those who are skilled in
the art, are also encompassed by the general concepts described
herein. Each and every feature described herein, and each and every
combination of two or more of such features, is included within the
scope of the present invention provided that the features included
in such a combination are not mutually inconsistent.
[0044] This application is directed to patient specific bone
grafts, methods for forming and using, as well as apparatuses for
forming, such grafts. As discussed above, patient specific grafts
can be clinically useful in supplementing eroded, thin or weak bone
to which a prosthesis component, such as a glenoid baseplate, is to
be coupled. BIO-RSA is one procedure where such grafts can be used.
The apparatuses and methods disclosed herein enable novel and less
traumatic bone preserving joint replacement techniques. The
apparatuses and methods disclosed herein can extend orthopedic
treatments to patients who would otherwise not be treatable and can
help preserve the possibility of future revisions if needed.
[0045] FIG. 1 shows a shoulder prosthesis 1 comprising a glenoid
component 10 implanted in the scapula S and a humeral component 20
implanted in the humerus H of a patient's shoulder. The glenoid
component 10 has a head 11 which has, on a lateral side, a convex
articular surface 11A of generally hemispherical shape. The lateral
side is a side facing away from the glenoid surface G of the
scapula S. The head 11 has an opposing face 11B disposed on a
medial side. The medial side is a side facing toward the glenoid
surface. In FIG. 1, the face 11B is generally planar but the face
11B can have other shapes. FIG. 1 illustrates what is sometimes
referred to as a reverse should prosthesis because the position of
the convex portion of the shoulder joint is the opposite of that of
normal anatomy.
[0046] FIG. 1A shows another approach to shoulder replacement where
a component 10' having a concave surface 32 is mounted to the
glenoid G. The component 10' is sometimes referred to herein as a
baseplate, though a baseplate can include any structure of a
prosthesis that directly contacts a side of a bone graft. The
concave surface 32 is configured to receive a spherical member of a
humeral component. An opposing face 34 of the component 10' is
oriented toward the glenoid G. The surface 32 is on a lateral side
of and the face 34 is on the medial side of the components 10'.
[0047] The glenoid components 10, 10' can also comprise an anchor
member 12 that extends from the face 11B (or the face 34) in the
direction away from the face 11A (or the surface 32). The free end
of the anchor member 12 is securely anchored in the scapula S
through the glenoid surface G when these components 10, 10' are
implanted to join the components to the scapula S. By way of
non-illustrated variation, the anchor member 12 can be externally
threaded or, generally, have a surface state promoting bony
ingrowth or other mode of anchoring. The anchor member 12 can be
separable from or a unitary construction with other the component
10, 10'.
[0048] A bone graft 2 is positioned between the glenoid surface G
and the face 11B, 34 of the respective glenoid components 10, 10'.
The bone graft 2 has a periphery 2A and a lateral surface 2B. The
lateral surface 2B is located on the side of the bone graft 2
disposed away from the glenoid surface G. The lateral surface 2B is
covered by the face 11B of the head 11 or by the face 34 of the
baseplate 10'. A medial surface 2C of the bone graft 2 faces and
usually is in direct contact with the glenoid surface G. Once the
bone graft 2 fuses with the glenoid surface G, the effective
glenoid surface is displaced laterally outward to the distal
surface 2B of the bone graft 2.
[0049] FIG. 1 shows that the bone graft 2 can have a non-constant
thickness. For example, a dimension L.sub.1 at the inferior portion
of the glenoid can be smaller than a dimension L.sub.2 at a
superior portion. Providing greater medial-lateral thickness at the
superior portion can compensate for wear. Because the bone
degradation or wear of every patient is different, the best
thickness of the bone graft 2 for superior and inferior portions
can be different for each given patient. Specific methods and
apparatuses to discern the best thickness profile or other
configuration of the bone graft 2 and to form the bone graft
accordingly are discussed hereinbelow. More particularly, the
medial face 2C preferably has a three-dimensional morphology that
matches the three-dimensional morphology of, e.g., is a negative
of, the glenoid or of the glenoid as the clinician intends to
modify it prior to mounting the glenoid component 10, 10' to the
scapula.
Methods Related To Making Patient Specific Bone Grafts
[0050] A number of methods can be employed to make bone grafts for
a joint procedure that are specific to a particular patient. These
methods can be performed by a manufacturer of prostheses, by an
imaging service provider, by a surgeon, or by a combination of an
imaging service provider, a manufacturer, and a surgeon at the
direction and under the control of the surgeon or other
participants in these processes.
[0051] FIG. 2 shows an embodiment of a method 100 for making a
patient specific insert negative 800. FIG. 8(A) shows an example of
the patient specific insert negative 800. The patient specific
insert negative 800 is referred to as a negative because, as
discussed further below, a contoured surface 808 thereof has a
shape that matches but is the opposite or is the negative of a
shape to be formed on a bone graft blank B. The bone graft blank B
is in turn a negative of a corresponding surface of the glenoid.
The negative 800 is sometimes referred to as an "insert" herein
because in certain approaches, the negative 800 is a separate
component of a bone press and is inserted into the bone press prior
to making the patient specific bone graft. This approach allows a
bone press to be reusable while the negative 800 can be used for
one specific procedure, then discarded as discussed below. However,
as discussed further below, a patient specific bone press could be
used, in which the contoured surface 808 of the negative 800 is
integrated into and may not be inserted into nor removed from a
bone press.
[0052] FIG. 2 shows a method that can be performed by or at the
direction of a manufacturer of prosthetic joint components. In a
step 104 three dimensional spatial location information of a bone
portion of a joint is obtained. Any suitable technology can be used
to obtain the spatial location information. For example, one or
more imaging technologies such as CT scanning, X-rays imaging or
the like can be used to generate spatial location information. A
mechanical device, such as a profilometer could be used to generate
spatial location information without imaging. Three dimensional
spatial location information can be obtained as one part of a
broader process for characterizing the bone portion to determine
how to treat the patient. For example, in the case of performing a
shoulder replacement, a degree of retroversion may be determined to
assess whether to perform an anatomical shoulder replacement (FIG.
1A) or a reverse shoulder replacement (FIG. 1).
[0053] In a step 108, the patient specific insert negative 800 is
formed. As discussed above, the negative 800 is configured with a
contoured surface 808 to be an opposite of the bone graft to be
formed in a bone press. The shape of the contoured surface 808 can
be derived from the information concerning a bone portion that was
characterized in the step 104. Therefore the step 108 can include
shaping a first side 804 of the negative 800 based upon the three
dimensional information. The patient specific insert negative 800
is configured to be advanced into engagement with a side of a bone
graft blank B as shown in FIGS. 6 and 7(A). As discussed in more
detail below, the bone graft blank B includes a volume, e.g., a
cylinder or a plurality of pieces, of bone matter that does not
necessarily match the shape of the glenoid surface or other bone
portion analyzed in connection with step 104. In certain methods,
the shape of the bone graft blank B is altered by being compressed
against the negative 800 in a bone press. The negative 800 thus
must be sufficiently stiff to retain the shape that is based upon
the three dimensional information obtained in the step 104.
[0054] FIGS. 8(A) and 8(B) show embodiments of patient specific
insert negatives 800, 800'. The insert negatives 800, 800' includes
the first side 804 configured to change a generic shape of a
surface of the bone graft blank B or other bone material into a
patient specific shape as discussed further below. The insert
negatives 800, 800' also include a second side 806, 806' opposite
the first side 804. The insert negative 800, 800' also includes a
peripheral surface 807 that extends between the first side 804 and
the second side 806, 806'. The first side 804 can includes a
contoured surface 808. The contoured surface 808 can have a first
portion 812 that corresponds to a portion of bone to be augmented
and a second portion 816 (best seen in FIG. 8(B), but corresponding
surfaces could be provided in the embodiment of FIG. 8(A)). The
second portion 816 can be configured to be mated with a portion of
a bone that is to be augmented differently. The second portion 816
can be configured to be mated with a portion of a bone that is to
be augmented by a lesser amount than the portion to which the first
portion 812 of the contoured surface 808 is to be mated to.
[0055] As discussed above, the surface 804 is an opposite of or a
negative of the surface to be created on the bone graft blank B.
Accordingly, the second portion 816 which is configured to form the
zone to provide lesser augmentation on the bone graft blank B
extends away from the second side 806, 806' by a first amount. The
first portion 812 which is configured to form a zone of greater
augmentation on the bone graft blank B extends away from the second
side 806, 806' by a second amount less than the first amount which
is provided in the second portion 816. In one embodiment, the
second portion 816 comprises a planar surface disposed in a plane
that is perpendicular to a direction of compression C in a bone
press. The direction of compression C can be generally along an
axis extending through a central aperture 828 of the patient
specific insert negative 800, 800'. The first portion 812 can be a
planar portion that is disposed along a plane that is oriented at
an acute angle to the axis C. The second portion 816 can be
inclined toward the second side 806. The first portion 812 can have
a boundary contiguous with the second portion 816 and can be spaced
away from the plane of the second portion at locations away from
the contiguous boundary. An advantage of providing two planar
portions is that it enables the surgeon to perform two reaming
steps to create two planar bone surfaces to which planar surfaces
of a patient specific bone graft formed by the negative 800 can be
mated.
[0056] One skilled in the art will recognize that more complex
shapes can be formed by forming the first and second portion 812,
816 with complex geometries or by providing more portions on the
first side 804 resulting in a more complex contoured surface 808.
The advantages of more complex contoured surfaces include allowing
the patient specific bone graft to more closely conform to the
patient's natural anatomy. This can allow the surgeon to modify the
bone to a lesser extent or even to just apply the patient specific
bone graft to the glenoid without much or any modification.
[0057] To achieve more complex configurations, the contoured
surface 808 can be based on three dimensional spatial location
information obtained in the step 104 of FIG. 2. The patient
specific insert negative 800 is configured to be mounted on or in a
bone press, for example as described below. The bone press and the
patient specific insert negative 800, 800' cooperate to shape the
volume of bone material, which can be formed as a bone graft blank,
as discussed below, upon application of pressure in the bone
press.
[0058] The second side 806' is configured to mate with a bone press
as discussed in greater detail below in connection with FIGS.
9-11E. The second side 806, 806' can have a surface 840 for
engaging a surface of a compression plate 644 of the bone press
600. The compression plate 644 can include a surface oriented
perpendicular to a direction of advance of the compression plate
644 in the press 600, which generally corresponds to the axis C.
The second side 806' can also be configured with a keyed projection
844'. The keyed projection 844' can be configured to be received in
a slot 657 of the bone press 600 of FIGS. 9-11E or in a slot 580A
of the compression plate 528A of the bone press 500A of FIG. 6A. A
keyed interface between the keyed projection 844 and the slot 657
(see FIG. 11(C)) provides a secured interface between the negative
800 and the bone press 600. The projection 844 and the slot 657
retain the insert negative 800 in a fixed rotational position. The
fixed rotational position prevents rotation of the first surface
804 relative to an opposing surface of the bone graft blank B as
discussed further below.
[0059] The second side 806 of the insert negative 800 can include a
generally flat surface 840 although it may be rounded toward the
periphery. In one embodiment, the insert negative 800 includes a
keyed projection 844 that extends along the peripheral surface 807.
The projection 844 can extend laterally into a longitudinal channel
580 discussed in more detail below. The peripheral surface 807 can
include indicia 849 that are useful in confirming a degree of
compression of the bone graft blank B as discussed further below.
The indicia 849 are patient specific in that they may provide a
relationship between the surfaces 812, 816 and a degree of
compression due to movement of the surfaces in a bone press as
discussed further below.
[0060] Further features that are convenient for integrating the
patient specific bone insert negative 800 into a bone press are
discussed below in connection with the bone press 600.
[0061] The method of FIG. 2 can advantageously be performed in a
number of different settings. For example, a special facility can
be used to form the patient specific insert negative 800. The
insert negative 800 will be subject to high compression, e.g.,
pressures and forces, in some embodiments. The insert negative 800
will be formed of a material that will not yield under such
conditions. Suitable materials include one or more of stainless
steel, maraging steel, cobalt chromium, inconel, nickel alloys,
aluminum, titanium, PEEK, and other polymers.
[0062] In one process flow, step 104 is performed at an imaging
center that can be run by the surgeon or at a separate facility.
Data generated in the step 104 can be transmitted by any means to a
manufacturing facility that can create the insert negatives. In
another approach, the step 108 can be performed with equipment that
could be located in a factory or in a surgeon's facility. For
example, direct laser metal sintering and other three-dimensional
printing technologies could be adapted to be deployed in either
setting to form the patient specific insert negative 800 in the
step 108.
[0063] FIG. 3 illustrates another method 200 that can be performed
by an implant manufacturer or a surgeon. The method 200 will be
discussed in connection with certain features of a bone press 500,
shown in FIGS. 5-7E. However any other bone press compatible with
the method could be provided, including any of the bone presses
described herein. In one approach, the method 200 is performed by
the surgeon or surgical staff or under a supply agreement between
the surgeon and a third party.
[0064] In a step 204 the bone press 500 is provided. The bone press
500 is provided with the patient specific insert negative 800. The
patient specific insert negative 800 can be produced by the method
100 or otherwise. The negative 800 can be produced by a third party
and supplied to the party performing the method 200.
[0065] The patient specific insert negative 800 can be provided in
a pressing zone 540 of the bone press 500. The pressing zone 540
includes a volume that is contained within structures of the bone
press 500. For example, as discussed below the bone press 500
includes a base 504, a housing 508, and an actuator 512. The
pressing zone 540 is defined in the bone press 500 between ends
thereof by the base 504 and the patient specific insert negative
800. An outer bound of the pressing zone 540 is defined by an
inside surface 510 of the housing 508. The housing 508 can be a
solid cylindrical sleeve. In some embodiments, the housing 508 is
clear or has a clear portion such that compression of the bone
graft blank B therein can be observed by the user. The housing 508
can have an inner diameter that is about the same dimension as an
outer diameter of a cylindrical bone graft blank B. In one
embodiment, the bone graft blank B is about 25 mm in diameter and
the inner diameter of the housing 508 is about 25 mm. In another
embodiment, the bone graft blank is about 25 mm in diameter and the
inner diameter of the housing 508 is about 26, about 27, about 28,
about 29, or about 30 mm. In another embodiment, the inner diameter
of the housing 508 can be 20-30% larger than the diameter of the
bone graft blank B.
[0066] The housing 508 could be formed with indicia instead of or
in addition to the insert negative 800 to provide feedback to the
user as to the degree of compression of a bone graft blank in the
bone press 500.
[0067] In step 208 a bone graft blank B is placed in the pressing
zone 540. Although the bone graft blank B can be placed directly on
the base 504, in certain variants of the method another structure
can be placed on the base 504 and that other structure can define
an end or a portion of the pressing zone 540.
[0068] FIGS. 5-7E illustrate methods when the glenoid component 10'
optionally is placed on the base 504. In a modified embodiment, the
methods of FIGS. 5-7E can be performed without the glenoid
component 10' placed on the base 504, e.g., with a bone graft blank
placed directly on the base 504. The glenoid component 10' defines
a portion of the pressing zone 540. In particular, the medial face
34 of the glenoid component 10' can form an end of the pressing
zone 540. As discussed above, the glenoid component 10' has anchor
member 12'. The opposing face 32 provides an end of the pressing
zone 540. In one variation of the method 200, the anchor member 12'
is disposed in the pressing zone 540. The step 208 can involve
placing a cylindrical bone graft blank B over the anchor member
12'. In this variation, the anchor member 12' is radially inward of
and is surrounded by the bone graft blank B. In this variation, the
bone graft blank B is radially inward of and is surrounded by the
housing 508. The pressing zone 540, e.g., the space where
compression of the bone graft blank B occurs, can be at least
partially defined between the anchor member 12' and the housing
508.
[0069] The method 200 can continue with a step 212 in which the
bone graft blank B is placed under compression. The compression can
be due to pressure being applied to medial and lateral ends
B.sub.1, B.sub.2 of the bone graft blank B. The compression can be
due to a force being applied to medial and lateral ends B.sub.1,
B.sub.2 of the bone graft blank B. Compression can be applied in
the pressing zone 540 by providing relative motion between the
patient specific insert negative 800 and the base 504 or a portion
of the base 504 or of a component coupled with the base.
[0070] The step 212 can involve actuating the patient specific
insert negative 800 and thereby moving the negative 800 toward the
cover 504 as indicated by an arrow A in FIG. 6. In the bone press
500, the patient specific insert negative 800 is moved toward the
base 504 by the actuator 512. The patient specific insert negative
800 is moved by rotating a screw member or ram 524 to advance a
compression plate 528 toward the base 504. The compression plate
528 can include a rigid plate configured to couple with the patient
specific insert negative 800.
[0071] Other structures that could be used to move the patient
specific insert negative 800 into compression with the bone graft
blank B can include a lever arm (discussed below in connection with
12-14B), a pneumatic mechanism, or other similar mechanisms. The
actuator 512 can be hand operated or automatically driven. The
actuator 512 can have a handle with an arcuate form between lateral
ends thereof to conform to the shape of the palm of the hand of a
user.
[0072] In a step 216, the bone graft blank B is reshaped to form a
patient specific bone graft. For example, the compression provided
in the step 212 can be continued or increased until ends of the
bone graft blank B change their shape in a suitable manner. The
reshaping can involve shortening the bone graft blank along the
axis C by 25-75%, by 35-65%, for example by about 50%. The
reshaping can include modifying a planar or irregular medial side
or end B.sub.1 of the bone graft blank B to have a specified
profile. For example, as discussed above the first side 804 of the
insert negative 800 can have a profile that matches a glenoid shape
or a shape to which the glenoid will be modified in a surgical
procedure. In one example, the glenoid is to be reamed to planar
faces that are disposed along a contiguous boundary but angled to
one another. In such case, the insert negative 800 is formed to
have a shape that matches that of the glenoid or the shape to which
the glenoid is to be modified. In the step 216, the insert negative
800 can have two angled faces on the medial side as shown in FIG.
8(B). The compression can be continued or increased by continuing
to move the insert negative 800 toward the base 504 after initial
contact is made between the insert negative 800 and the bone graft
blank B. Such movement can continue for 10-20 mm or for up to about
50% or even as much as 60%, 65%, or even 70% of the initial
uncompressed length of the bone graft blank B. The step 216 causes
the bone graft blank B to be compressed and to conform to a surface
of the negative 800 and generally to irreversibly deform so as to
hold the shape once compression is removed. This is not an elastic
deformation only where the bone springs back to its initial shape
once compression is removed, though some limited recoil may
occur.
[0073] FIG. 4 illustrates a method 300 in which three dimensional
spatial location information is obtained and a patient specific
bone graft is produced. This method can be conducted by or under
the direction of a surgeon or by or under the direction of a third
party, such as an implant manufacturer. The method 300 includes a
step 304 in which three dimensional spatial location information is
obtained. The step 304 can be similar to the step 104, such as
including the conducting of a CT scan or x-ray of a relevant
portion of a patient's bone or joint.
[0074] In a step 308 a prosthesis component, such as the component
10', optionally is placed in a bone press. With reference to FIG.
7A, the component 10' can be placed directly onto the base 504 of
the bone press 500. In another variation, the component 10' can be
placed on an impactor 690. Thereafter, a portion of the impactor
690 and the prosthesis component can be placed in the bone press
together. In another variation, the component 10' is not placed in
the bone press 500 during a method of forming a patient specific
bone graft.
[0075] In a step 312, a bone graft blank, such as blank B, is
placed in the bone press 500. FIG. 6 shows that the bone graft
blank B can be placed in the bone press 500 in a location between
the base 504 and the patient specific insert negative 800. In one
method, an end or lateral side B.sub.2 of the bone graft blank B
faces toward the base 504 and an end or medial side B.sub.1 faces
toward the patient specific insert negative 800. As discussed
above, the bone graft blank B can take any suitable form. In some
cases the bone graft blank B is a cylinder of bone with the sides
B.sub.1, B.sub.2 being generally flat opposing sides and having a
generally circular body extending therebetween. The bone graft
blank B can be obtained from a resected portion of the humerus or
from another bone segment. As a result, in some cases, the bone
graft blank B can be more irregularly shaped as a result of being
cut during a procedure from the patient undergoing shoulder
replacement. The bone graft blank B also can include two or more
pieces that are placed into the housing 508 and later compressed
into a single graft.
[0076] In one technique, the prosthesis component 10' with the bone
graft blank B mounted thereon is placed in a bone press, such as
the press 500. As shown in FIG. 7(A), for example, the component
10', which has an anchor member 12', can have a central lumen
B.sub.3 of bone graft blank B placed thereover. The lumen B.sub.3
can be sized to permit the bone graft blank B to be slipped over
the anchor member 12'. So, in one variation the step 312 includes
providing relative motion between the anchor member 12' of the
component 10' and the bone graft blank B such that the anchor
member 12' is moved into the lumen B.sub.3. After the bone graft
blank B is mounted on the prosthesis component 10', the component
and the blank can be placed into the bone press 500. In a
variation, the prosthesis component 10' is not placed in the bone
press 500. The blank B can be placed directly onto the base 504 or
another component of the bone press 500.
[0077] FIG. 6 shows that when the bone graft blank B is placed in
the bone press 500 the medial side B.sub.1 is adjacent to the
patient specific insert negative 800. In one approach no components
are placed between the medial side B.sub.1 and the first side 804
of the negative 800. Direct contact can be provided between the
medial side B.sub.1 and the first side 804 of the negative 800.
Direct contact allows the surface profile of the medial side
B.sub.1 and the first side 804 to be provided on the bone graft
blank B as discussed further below.
[0078] In a step 316 the bone graft blank B is compressed in the
bone press. FIG. 6 shows that the bone graft blank B is compressed
in the pressing zone 540 between the patient specific insert
negative 800 and the component 10'. More generally, the bone graft
blank B is compressed between the patient specific insert negative
800 and the base 504. The compression provided in the step 316 is
initially axial compression. Axial compression is along the
direction of the arrow A (FIG. 10). After an initial level of
compression, the bone graft blank B may expand transverse to the
direction A to some extent. However, the pressing zone 540 of the
bone press 500 is enclosed by the housing 508. So expansion
transverse to the lumen B.sub.3 is limited. The bone graft blank B
is disposed between the anchor member 12' and the housing 508. This
configuration can provide compression in the transverse
direction.
[0079] In a step 320 the bone graft blank B is reshaped. The step
320 can involve changing the length of the body of the bone graft
blank B from a first length to a second shorter length, as
discussed above in connection with the method of FIGS. 3. The step
320 can involve increasing the outer profile of the bone graft
blank B, for example from a first radius to a second larger radius.
If the shape of the medial side B.sub.1 of the bone graft blank B
has not been modified upon compression in the step 316, the step
320 can involve changing the side B.sub.1 to a shape matching, but
a negative of, that of the bone to which the bone graft blank B
will be mated after it is changed into a patient specific bone
graft. The step 320 causes the bone graft blank B to be compressed
and conformed and generally to irreversibly deformed so as to hold
the shape once compression is removed. This is not an elastic
deformation only where the bone springs back to its initial shape
once compression is removed, though some limited recoil may
occur.
[0080] Following the method of FIGS. 3 and 4 the bone graft that is
shaped in the bone press 500 (or other bone press) can be removed.
If the initial diameter of the bone graft blank B is similar to the
inner diameter of the housing 508 an ejector tool can be used to
push the bone graft out of the housing 508. The ejector can include
an elongate solid rod with a handle at one end and a disk or other
pushing plate at the other end. The disk or pushing plate is
configured to mate with and push the bone graft out of the housing
508. A kit including the bone press 500 (or other bone presses
disclosed or claimed herein) can include an ejector.
Bone Graft Presses
[0081] Turning now to FIGS. 5-14B a variety of bone graft presses
will be discussed in greater detail. The bone graft presses of
these embodiments can be hand operated. FIGS. 5 and 9 illustrate
bone presses in which an actuator is provided that includes a
threaded connection. FIG. 12 shows a bone press that includes a
single motion actuator, e.g., a non-threaded actuator, e.g., an
actuator with a lever, to provide compression of a bone graft blank
B. The bone graft presses can be used to form a patient specific
bone graft directly on a component to which the bone graft is to be
coupled. FIGS. 5-7(E) illustrate bone presses that form a patient
specific bone graft directly on a glenoid baseplate to be coupled
with an impactor or other surgical tool after the patient specific
bone graft is formed. FIGS. 9-14(B) show a bone press that permits
an impactor to be coupled with a glenoid baseplate prior to the
formation of the bone graft in the bone press such that the
baseplate and the bone graft are ready to be implanted immediately
after the bone graft is removed from the bone press.
[0082] FIGS. 5-7(E) illustrate the bone press 500 in greater
detail. The bone press 500 is configured to receive the bone graft
blank B and the prosthesis component 10' together in the pressing
zone 540. In other embodiments the bone graft blank B could be
placed the pressing zone 540 without the component 10'. The
actuator 512 of the bone press 500 includes a threaded mechanism
for advancing the actuator 512 toward the base 504 which allows for
a large amount of compression, if desired.
[0083] FIG. 5 shows that the base 504 can comprise a plate-like
configuration. That is, a lower surface 544 can be planar in shape
allowing the base 504 to rest on a table or other flat surface in
use. The lower surface 544 would be the bottom of the bone press
500 in such arrangements with an upper part of the actuator 512
being the top of the bone press. The bone press also can include
two side surfaces 548 to which the actuator 512 is coupled. The
side surfaces 548 can include threaded apertures 550 to which
threaded members 552 of the actuator 512 can be coupled (see FIG.
6). In one embodiment the threaded apertures 550 comprise end
portions of one elongate lumen that extends from one of the
surfaces 548 to the other of the surfaces 548.
[0084] FIG. 7(A) shows that an upper surface of the base 504 can
include a platform 555 configured to couple with the component 10'
or other joint component. The platform 555 preferably allows the
component 10' to be quickly coupled with the platform 555 to
prevent rotation of the component 10' relative to the platform 555.
For example a central post 556 can be provided that can be received
into an aperture of the component 10'. One or more peripheral posts
557 can be provided spaced apart from the central post 556. The
peripheral posts 557 also are received in apertures of the
component 10'. The peripheral posts 557 prevent any torque that may
be induced in the pressing zone 540 from resulting in rotation of
the component 10' or from transmission of torque transferred
between the upper surface 554 and the component 10' from being
applied to the bone graft blank B. Providing isolation from some or
substantially all such torque can be important if the material of
the bone graft blank B is fragile because the goal of the bone
press is to output a solid patient specific bone graft that will
not crumble in subsequent using during a joint implantation
procedure. The platform 555 can also be a locally elevated portion
of the upper surface of the base 504. For example, upward
cylindrical projection 558 can be provided on the upper surface of
the base 504. The projection 558 allows the component 10' to come
to rest at an elevation above a portion of the upper surface 554
located outward of the projection 558. The projection 558 can have
a circular periphery with an outer radius less than the inner
diameter of the housing 508 such that the housing can be advanced
over the projection 558 and come into contact with the upper
surface 554 at a location outward of the projection 558. This
configuration allows the entire platform 555 to be received in the
housing 508 during the compression of the bone graft blank B.
[0085] FIGS. 5 and 6 show the actuator 512 in more detail. The
actuator 512 includes a frame 559 that provides a rigid connection
to the base 504. In one embodiment the frame 559 includes two bars
560 that are pivotally connected at a first end 562 to the base 504
by the threaded members 552. The bars 560 include an elongate rigid
portion that extends from the first end 562 to a second portion 564
at which the bars 560 are linked. The second portions 564 can be
linked by a transverse bar 566. In some configurations, the bars
560 and the transverse bar 566 are portions of a unitary
construction, e.g., they can be monolithic, they can be a single
piece, and/or they can be seamless without boundaries between them.
The bars 560 and the bar 566 (if present) transfer forces between
the base 504 and a compression plate 528 of the actuator 512. The
compression plate 528 is advanced by action of a handle 567.
[0086] FIGS. 5 and 6 show that the compression plate 528 can be
placed between the handle 567 and the base 504. A ram 524 is
coupled at one end with the compression plate 528 and at an
opposite end with the handle 567. The ram 524 is configured to be
advanced relative to the transverse bar 566, for example by a
threaded connection. The ram 524 can have a threaded external
surface 568 that mates with internal threads of a hole 570 formed
in the inside surface of a hole formed in the transverse bar
566.
[0087] The connection between the handle 567 and the ram 524 can be
any suitable connection. A suitable connection will transfer torque
from the handle 567 to the ram 524 such that rotation of the handle
is transferred directly into rotation of the ram. Such connection
will generally prevent any relative rotation between the handle and
the ram. The handle 567 can be directly coupled to the ram 524,
such as by a pin or screw to assure one-to-one rotation between
these components. The handle 567 and the ram 524 could be formed as
a single component, e.g., be unitary in some configurations. The
connection between the ram 524 and the compression plate 528
preferably is one which advancement of the ram 524 toward the base
504 is transferred one-to-one to the compression plate. The
compression of the bone graft blank B that is preferred is
primarily or substantially only in the axial direction. In this
context, the axial direction is a direction defined along the
central axis of the lumen B.sub.3. The axial direction also can be
defined as perpendicular to one or both of the surfaces B.sub.1,
B.sub.2 of the bone graft blank B. To provide no or substantially
no circumferential compression of the bone graft blank B the
compression plate 528 is configured to remain rotationally fixed
during advancement of the compression plate. Relative rotation of
the compression plate 528 is provided by the connection between the
plate 528 and the ram 524.
[0088] FIG. 6 shows one mechanism for providing relative rotation
between the compression plate 528 and the ram 524. In particular, a
coupler 572 can be provided between an upper side of the
compression plate 528 and the ram 524. The coupler 572 can include
a stepped cylindrical recess 574 formed in the ram 524. The recess
574 can more generally be an arcuate chamber in some embodiments.
The lower end of the ram 524 can receive a pin or axle with an
arcuate surface 576 defined thereon. The arcuate surface 576 can
optionally be stepped and preferably has a slip fit relative to the
recess 574. The coupling of the cylindrical recess 574 and the
arcuate surface 576 provide for rotation of the compression plate
528 relative to the ram 524. Although shown as a pin and recess
connection, the connection could be one that provides at least one
additional axis of rotation
[0089] FIG. 6A shows another embodiment of a bone press 500A that
is similar to the bone press 500 except as described or illustrated
differently. The bone press 500A has a mechanism for providing
relative rotation between a compression plate 528A and a ram 524A.
In particular, a coupler 572A can be provided on an upper side of
the compression plate 528A. The coupler can have an arcuate chamber
574A defined therein. The arcuate chamber 574A is at least
partially spherical in one embodiment. The lower end of the ram
524A can have an arcuate surface 576A defined thereon. The arcuate
surface 576A can comprise an at least partially spherical surface.
The coupling of the arcuate chamber 574A and the arcuate surface
576A provide for relative rotation of the compression plate 528A
relative to the ram 524A. Although shown as a ball and socket
connection, the connection could be one that provides relative
rotation about fewer axes, e.g., about two axes. Also, the
compression plate 528A can have a keyed arrangement formed thereon,
as discussed further below.
[0090] FIGS. 7(A)-7(E) show how the bone press 500 is used. In FIG.
7(A), the ram 524 and the compression plate 528 are raised by
actuating the handle 567 to a position spaced away from the base
504. The plate 528 can be moved as far away from the base 504 as
possible, in a position that may be described as fully retracted.
The threaded members 552 can be loosened if necessary to permit the
actuator 512 to be moved away from the platform 555 to allow access
to the platform. The component 10' or other similar component can
then be placed on the platform 555. Apertures in the component can
be placed over the central and peripheral posts 556, 557. In this
position the component 10' is secured to the platform 555 against
undesirable rotation. The base 504 is rigid and holds the component
10' against axial movement away from the compression plate 528.
[0091] FIG. 7(B) shows that the bone graft blank B can thereafter
by placed over the component 10'. For example, the lumen B.sub.3 of
the bone graft blank B can be advanced over the anchor member 12'.
The anchor member 12' can be received in the lumen B.sub.3. The
lateral surface B.sub.2 of the bone graft blank B can be placed
directly on the medial side of the component 10'. FIG. 7(B) shows
the component 10' and the bone graft blank B on the base 504 in a
zone where the pressing zone 540 will be formed. The component 10'
and the bone graft blank B are disposed on the projection 558 at an
elevation above the surrounding areas of the platform 555.
[0092] FIG. 7(B) shows that the housing 508 and the patient
specific insert negative 800 are spaced apart from the rest of the
bone press 500 at this point of one method. These components could
be at the surgical table or on a back table in the operating room
or could be elsewhere if the bone graft blank is formed well before
the surgery.
[0093] FIG. 7(C) shows a later step in which the housing 508 is
advanced over the bone graft blank B. The housing 508 can be
advanced over the bone graft blank B and over the component 10' if
present. In the illustrated method, the housing 508 is advanced
over the blank B, the component 10' and over the projection 558
into contact with a surrounding portion of the platform 555. In
this position the pressing zone 540 is enclosed other than an upper
portion where the patient specific insert negative 800 is to be
placed.
[0094] FIG. 7(C) also shows a clocking element 578. The clocking
element 578 provides pre-defined rotational position of the patient
specific insert negative 800 relative to the housing 508. For some
embodiments, specific orientation of the negative 800 relative to a
bone press is useful for providing proper orientation or position
of an augment on an asymmetrical bone graft. For example if a bone
graft has an oblong, e.g., rectangular, cross section and the
augment is to be provided at a specific region, e.g., along a long
axis or a short axis of the bone graft, the position of the insert
negative 800 relative to the housing 508 should be pre-defined to
assure that the negative 800 produces the augment in the desired
location. In other embodiments it is sufficient that the rotational
position of the negative 800 relative to the housing 508 or the
pressing zone 540 is sufficient to prevent circumferential
compression which could result in shearing of the bone graft blank
B. In one embodiment the housing has a cylindrical configuration
with the inner periphery of the housing 508 being circular. At one
or more locations of the inner periphery the periphery extends
outwardly to form a longitudinal recess or channel 580 in the inner
surface. The longitudinal channel 580 allows a projection 582 on
the outer surface of the patient specific insert negative 800 to be
received and to slide as the negative 800 is advanced in the
housing 508. The channel 580 and the projection 582 engage to
prevent relative rotation of the negative 800 and the housing 508
during such advancement. In another embodiment, the clocking
element 578 can include channels on the patient specific insert
negative 800 and projections on the housing 508. The channels or
projections extends or extend from an upper surface of the housing
508 toward the lower surface thereof. The channel(s) or
projection(s) can extend entirely between the upper and lower
portions of the housing 508. Although the illustrated embodiment
has only one channel 580, the clocking element 578 could include a
plurality of channels 580 or projections if the purpose of the
clocking element 578 is only for preventing rotation during
movement of the patient specific insert negative 800.
[0095] FIG. 7(D) shows the insert negative 800 placed into the
housing 508. The projection 582 is received in the channel 580.
This provides a specific rotational position and also prevents or
limits circumferential compression.
[0096] FIG. 7(E) shows the compression plate 528 moved into contact
with an upper surface 840 of the patient specific insert negative
800. After the compression plate 528 is in such contact, the handle
567 can be actuated to move the ram 524 and the compression plate
528 coupled therewith toward the base 504 to create compression of
the bone graft blank B. Such compression can begin to compress the
bone graft blank B. Further compression can cause the bone graft
blank B to be reshaped. The reshaping of the bone graft blank can
cause the medial surface of the bone graft blank B to form a shape
matching the shape of the glenoid surface either as it is prior to
surgery or after a prescribed amount and type of reaming. After the
compression and/or reshaping the bone graft blank B is formed into
a patient specific bone graft B'.
[0097] FIG. 7(F) shows that in one example the patient specific
bone graft B' has a first side that is or can be coupled with the
prosthesis component 10' and a second side. The patient specific
bone graft B' configured for the shoulder will have a contoured
surface B.sub.1' that corresponds to a shape of a glenoid. The
surface B.sub.1' is a patient specific bone facing portion, e.g., a
portion that is configured to face glenoid of a patient. That is,
the contoured surface B.sub.1' is a negative of the surface of the
glenoid. The contoured surface B.sub.1' can have a first planar
portion B.sub.4 and a second planar portion B.sub.5. The planar
portions B.sub.4, B.sub.5 are configured to be nested in and to
closely match the surfaces of the glenoid that are unaltered or
that have been prepared by minimal reaming or other preparation
method. The patient specific bone graft B' has a body that extends
between the surface B.sub.1' and a surface B.sub.2 opposite the
surface B.sub.1'. The body of the bone graft B' is configured to
adjust the spacing of a prosthesis component coupled with the side
or surface B.sub.2 from a surface of the bone to which the
contoured surface B.sub.1 or patient specific bone facing potion is
coupled. The specific bone graft B' generally is compressed, as
discussed herein within any of the bone presses herein. The
specific bone graft B' can be formed from a single, monolithic
piece of bone or from a plurality of pieces of bone. The specific
bone graft B' can comprise natural bone matter or synthetic bone
matter. The specific bone graft B' can include a lumen B.sub.3
therethrough configured to receive a portion of a prostheses, such
as the component 10' as shown herein.
[0098] FIG. 9 shows another embodiment of a bone press 600 that can
be used to compress or reshape a bone graft blank B. The bone press
600 is similar to the bone press 500 except as described
differently below. The bone press 600 includes a pressing zone 604
defined within a housing 608. The housing 608 includes a first
shell 612 and a second shell 616. The first shell 612 comprises at
least a portion of a base 620 configured to support either directly
or indirectly the advancement of the patient specific insert
negative 800. In the illustrated embodiment, the first shell 612
includes a first portion of the base and the second shell 616
comprises a second portion of the base 620. In a variation the base
620 is disposed on only one of either the first shell 612 or the
second shell 616.
[0099] The first shell 612 and the second shell 616 meet at an
interface, which can be a planar interface. FIGS. 9 and 10 show
that each of the first shell and the second shell 612, 616
comprises a portion of an access aperture 624 for receiving a shaft
692 of the impactor 690. The aperture 624 allows the impactor 690
to pass through the base 620 into the pressing zone 604 within the
bone press 600.
[0100] The shells 612, 616 can each have a partially cylindrical
configuration. For example a cylinder portion 628 can extend away
from the portion of the base 620 formed by the shell 612 toward an
end of the bone press 600 opposite the base. A cylinder portion 632
can extend away from the portion of the second shell 616 toward the
opposite end. The cylinder portions 628, 632 can be half cylinders
in one embodiment. The inside surfaces of the cylinder portions of
the shells 612, 616 form the pressing zone 604. The outside
surfaces of the cylinder portions are threaded to enable
advancement of an actuator 636 as discussed below.
[0101] The shells 612, 616 can have one or more slots 640 formed
therein. The slots 640 are configured to permit a mechanical
connection between the actuator 636 and a compression plate 644
disposed in the pressing zone 604. In various embodiments there may
be one, two, three, four, five, six, or more slots 640. In the
illustrated embodiment, there are four slots 640. Each of the
shells 612, 616 has one slot 640 formed entirely therein. A slot
640 is formed on each side of the bone press along the interface
between the shells 612, 616.
[0102] The compression plate 644 includes a central portion 652
that can be disposed inside the pressing zone 604 of the bone press
600 and force transfer projection 656 extending peripherally from
the central portion 652. The compression plate has a force transfer
projection 656 for at least one of the slots 640. The compression
plate 644 can have one force transfer projection 656 for each of
the slots 640, as illustrated in the FIG. 11(C). By disposing the
force transfer projections 656 through the slots 640 the force
transfer projections can be engaged by the actuator 636 as
discussed below. The projections 656 can comprise an enlarged lobe
disposed outside the slot 640 and a narrow portion between the lobe
and the central portion 652.
[0103] The actuator 636 comprises a cylindrical portion 664 at a
first end 668 that includes a threaded interior 670. The first end
has a distal face 671 that acts on the compression plate 644. The
interior threads are configured to engage the exterior threads
disposed along the shells 612, 616. The threads on the shells 612,
616 and on the interior 670 enable advancement of the actuator 636
along the shells. The advancement of the actuator 636 engage the
compression plate 644 to push the compression plate into the bone
graft blank B to compress and/or re-shape the bone graft blank. The
actuator 636 has an enlarged hand grip 672. The hand grip 672 can
include one or more enlarged members that the hand grip 672 can
engage. The hand grip 672 can help increase the torque by extending
farther than does the cylindrical portion 664 away from an axis of
rotation of the actuator 636 about the shells 612, 616.
[0104] FIGS. 11(A)-11(E) illustrate the use of the bone press 600.
The impactor 690 has a first end with a handle 678 and a second end
with engagement features 680 to connect the impactor 690 with the
component 10'. FIGS. 11(B) shows that the user can therefore
connect the lateral side of the component 10' to the engagement
features 680 of the impactor 690. Thereafter the bone graft blank B
can be coupled with the component 10'. For example, thereafter
lumen B.sub.3 of the bone graft blank B can be placed over the
anchor member 12'. The anchor member 12' can be inserted into the
lumen B.sub.3 from the lateral side B.sub.2 of the bone graft blank
B until the lateral side of the bone graft blank B engaged the
medial side of the component 10'.
[0105] FIG. 11(C) shows that after the component 10' and the bone
graft blank B are coupled with the impactor 690 these components
can be coupled with the bone press. For instance, the shaft 692 of
the impactor 690 can be laid in a lower portion of the access
aperture 624. When so placed, the component 10' and the bone graft
blank B are disposed in the inside portion of the first shell 612.
The lateral side of the portion of the impactor 690 carrying the
engagement features 680 (see FIG. 11(A)) can be placed in the first
shell 612 such that the lateral side of the impactor is in direct
contact with the base 620. Thereafter the patient specific insert
negative 800 and the compression plate 644 are placed in the
pressing zone 604, e.g., into the interior surface of the first
shell 612. Specifically, the keyed projection 844 on the second
side 806 of the negative can be received in a corresponding slot
657 of the compression plate 644. In one technique the keyed
projection 844 is received in the slot 657 and thereafter the slot
657 and the plate 644 are placed in the first shell 612 such that
the contoured surface 808 of the insert negative 800 faces the bone
graft blank B and such that the bone graft blank B is between the
base 620 and the compression plate 644. FIG. 11(D) shows the
foregoing arrangement.
[0106] Following placement as in FIG. 11(D), a block 682 coupled
with the second shell 616 is placed over a bottom portion of the
base 620. The block 682 can be manipulated by a handle 684 coupled
with the block 682. The block 682 can be coupled with a bottom
portion of the base 620 in a suitable fashion. For example, a
plurality of projections 686 disposed on the lower side of the
block 682 can be received in a corresponding plurality of apertures
688 formed on the lower side of the base 620. The illustrated
embodiment shows that three projections 686 can be received in
three corresponding apertures 688 shown in the illustrated
embodiment.
[0107] FIG. 11(E) shows the second shell 616 coupled with the first
shell 612. Thereafter the actuator 636 can be threaded onto the
free end of the shells 612, 616. The threading of the actuator onto
the shells 612, 616 is facilitated by the hand grip 672. Further
threading, as indicated by arrow A (see FIG. 10), causes the
projections 656 of the compression plate 644 to be engaged by the
distal face 671 of the actuator 636 opposite the hand grip 672.
Further threading causes the actuator 636 to engage the projections
656 moving the compression plate 644 toward the bone graft blank B.
After compression has begun further advancement of the actuator 636
can cause the bone graft blank B to be reshaped such that the bone
graft blank can be re-formed from a generic shape to a shape
specifically configured for a particular patient, as discussed
above.
[0108] FIG. 5-7(E) illustrate that the bone press 500 provides the
benefit of high compression capability due to the threaded
connection between the ram 534 with the benefit of compressing
and/or reshaping the bone graft blank B into the patient specific
bone graft right on the component 10'. By forming the bone graft on
the component 10', the surgeon or another user can avoid
transferring bone graft to the component 10' which would require an
additional step and/or could result in damage to the bone
graft.
[0109] FIG. 9-11(E) illustrate that the bone press 600 provides the
benefit of high compression capability due to the threaded
connection between the actuator 636 and the shells 612, 616 with
the benefit of having, pre-loaded onto the impactor 690, the
component 10' and the formed patient specific bone graft formed
from the bone graft blank B in the bone press 600. As a result, the
surgeon is not required to load the bone graft and the component
10' onto the impactor 690. By forming the bone graft and the
component 10' preloaded on the impactor the surgeon or another
medical professional can avoid transferring the bone graft and the
component 10' to the impactor 690 which would require an additional
step and/or could result in the bone graft being displaced on or
from the component 10'.
[0110] FIGS. 12-14(B) show another bone press 700 that can be used
to form a patient specific bone graft from a bone graft blank B.
The bone press 700 provides a number of advantages, including
forming the bone graft on the impactor 690 and enabling formation
of the bone graft through a single pre-defined motion among other
advantages.
[0111] The bone press 700 includes a compression plate 702, a base
704, a housing 708, and an actuator 712. The compression plate 702
comprises a rigid plate-like configuration. The compression plate
702 has a first side 720 with a platform 722 and a second side 724
opposite the first side 720. The compression plate 702 has lateral
sides 728 to which the actuator 712 is coupled. The actuator 712 is
coupled to the compression plate 702 at the lateral sides 728 by a
plurality of pins 730, but threaded members or other connection
devices could be used. The first side 720 includes a keyed
interface that can include a linear protrusion 732 that retains the
patient specific insert negative 800 in a pre-defined rotational
position relative to the bone graft blank B. The keyed interface
also can include a peg 733 projecting away from the first side 720
of the compression plate 702 and away from the linear protrusion
732 toward the base 704. The patient specific insert negative 800
has a corresponding groove or slot 734. The slot 734 is sized to
receive the protrusion 732 of the interface. If provided, the peg
733 is received in an aperture, recess or a lumen 850 of the
patient specific insert negative 800 (See FIG. 13). Other couplings
could be provided between the patient specific insert negative 800
and the compression plate 702. For example, a plurality of pegs
could be provided projecting from the first side 720 to mate in
only one orientation with the patient specific insert negative 800.
The pegs could be on the patient specific insert negative 800, to
mate with apertures in the compression plate 702. The interface 732
could be on the patient specific insert negative 800 to mate with
the groove or slot 734 formed on the compression plate 702. Other
variations are also possible.
[0112] The base 704 has a first side 742 and a second side 744. The
base 704 is disposed opposite the compression plate 702 in the bone
press 700. The second side 744 faces the compression plate 702. The
housing 708 extends between the base and the compression plate. The
housing 708 has a first end 746 that contacts the compression plate
702 and a second end 748 that contact the base 704. A pressing zone
750 is formed between the patient specific insert negative 800
(mounted on the compression plate 702), the base 704, and the
housing 708. As discussed herein, the pressing zone 750 is a place
where compression of the bone graft blank B can occur. The base 704
also includes an access path 754 for receiving the impactor 690.
The access path 754 preferably extends from one of the sides of the
base 704, e.g., from a top side of the base 704. The access path
can comprise a U-shaped recess formed form the top side of the base
to a central portion of the base, e.g., to a position aligned with
a central longitudinal axis of the pressing zone 750.
[0113] The actuator 712 comprises a pair of bars 762 disposed on
opposite sides of the pressing zone 750. The bars 762 are pivotably
coupled with the base 704. Pins 764 extend through the bars 762 and
into the base. The pins 764 permit the bars to rotate from an
upright position, shown in FIG. 12, to inclined position, one of
which is shown in FIG. 13. The bars 760 are also rigidly connected
by a transverse bar 768. The bars 760 are also connected by a force
transfer rod 769. Movement between the pins 764 and the bars 762 is
limited to rotation in some embodiments. The force transfer rod 769
is able to pivot relative to the bars 760 and also can slide along
slots 770 formed in the bars. The slots 770 are formed in each bar
760, are parallel to each other, and have the same length in some
embodiments. FIGS. 12-14(B) all show the force transfer rod 769 at
an end of the slot corresponding to a state of compression. The
force transfer rod 769 can move toward or to the opposite end of
the slot 770, which corresponds to a more open configuration of the
bone press 700. In one embodiment, the slots 770 are eliminated and
the bars 760 can be pivotably coupled with a force transfer member
such without any movement of the force transfer member relative to
the bars 760. The actuator 712 also includes a handle 772 that can
be grasped by a user in order to move the actuator 712 between an
upright position, as in FIG. 12 and an inclined position as in FIG.
13. The upright position is one in which compression can occur in
the pressing zone 750. The inclined position is one in which
compression is reduced or eliminated compared to the upright
position. In some inclined position the pressing zone 750 can be
opened and accessed to load the component 10' and/or the bone graft
blank B.
[0114] FIGS. 14(A)-14(B) show how the bone press 700 can be used.
In the illustrated embodiment, the bone press 700 is configured to
compress and reshape a bone graft blank B mounted on the impactor
690. Prior to compressing the bone graft blank B, the actuator 712
is placed in an inclined position, as shown in FIG. 13-14B. FIG. 13
shows that bone press 700 can receive the component 10' as well as
the blank B. Accordingly, in one variation of the bone press 700
the component 10' and the bone graft blank B can be mounted to the
impactor 690 as shown in FIGS. 11(A)-11(B). The combination of the
impactor 690, the component 10' and the bone graft blank B can be
coupled with the base 704. In one embodiment, the shaft 692 is
inserted into the access path 754. Thereafter, the component 10'
can be mounted to engagement features 680 of the impactor 690 at a
location between the base 704 and the compression plate 702. A bone
graft blank B is then advanced over the anchor member 12'.
[0115] The pressing zone 750 then can be formed by placing the
housing 708 over the bone graft blank B. The insert negative 800
can be mounted to the peg 733. The pressing zone 750 can be
enclosed by placing the patient specific insert negative 800 into
the housing 708 as shown in FIG. 13.
[0116] After the pressing zone 750 is enclosed, the actuator can be
moved from an inclined position, as in FIGS. 13-14(B), toward an
upright position as shown in FIG. 12. FIG. 13 shows a gap between
the patient specific insert negative 800 and the medial side
B.sub.1 of the bone graft blank B. A first movement of the actuator
712 from the inclined position of FIG. 13 toward the upright
position of FIG. 12 the gap is closed and contact between the
patient specific insert negative 800 and the medial side B.sub.1 of
the bone graft blank B. Further movement causes compression of the
bone graft blank B. After compression of the bone graft blank B,
further movement of the actuator 712 reshapes the bone graft blank
B. The reshaping can be such that the bone graft blank B is formed
into a patient specific bone graft.
[0117] The bone press 700 provides the advantage of transforming
the bone graft blank B into a patient specific bone graft without
requiring a repeating motion, such as threading one member relative
to another. Rather, the transformation can result from a single
motion from an inclined configuration (as in FIGS. 13-14(B) or more
inclined) to an upright position as in FIG. 12. The arrangement of
the bars 760, 762 also can be arranged to create a great deal of
compression in the pressing zone 750. The amount of compression can
be tailored by the location of the force transfer member 769 and
the handle 772.
Terminology
[0118] Although certain embodiments have been described herein with
respect to an anatomic component or a reverse component, the
implants and methods described herein can interchangeably use any
articular component, including the anatomic and reverse components
described herein, as the context may dictate.
[0119] As used herein, the relative terms "proximal" and "distal"
shall be defined from the perspective of the implant. Thus,
proximal refers to the direction of the articular component and
distal refers to the direction of the base plate when the implant
is assembled.
[0120] Note that the terms "first" and "second"' articular
components can be used interchangeably and to refer to the anatomic
components or the reverse components. Accordingly, the "first" and
"second" openings can be used interchangeably and to refer to any
one of the openings in the baseplate.
[0121] Conditional language, such as "can," "could," "might," or
"may," unless specifically stated otherwise, or otherwise
understood within the context as used, is generally intended to
convey that certain embodiments include, while other embodiments do
not include, certain features, elements, and/or steps. Thus, such
conditional language is not generally intended to imply that
features, elements, and/or steps are in any way required for one or
more embodiments.
[0122] The terms "comprising," "including," "having," and the like
are synonymous and are used inclusively, in an open-ended fashion,
and do not exclude additional elements, features, acts, operations,
and so forth. Also, the term "or" is used in its inclusive sense
(and not in its exclusive sense) so that when used, for example, to
connect a list of elements, the term "or" means one, some, or all
of the elements in the list.
[0123] The terms "approximately," "about," and "substantially" as
used herein represent an amount close to the stated amount that
still performs a desired function or achieves a desired result. For
example, the terms "approximately," "about," and "substantially"
may refer to an amount that is within less than 10% of the stated
amount, as the context may dictate. As an example, in certain
embodiments, the term "generally perpendicular" refers to a value,
amount, or characteristic that departs from exactly perpendicular
by less than about 10 degrees.
[0124] Although certain embodiments and examples have been
described herein, it will be understood by those skilled in the art
that many aspects of the glenoid implants shown and described in
the present disclosure may be differently combined and/or modified
to form still further embodiments or acceptable examples. All such
modifications and variations are intended to be included herein
within the scope of this disclosure. A wide variety of designs and
approaches are possible. No feature, structure, or step disclosed
herein is essential or indispensable.
[0125] Some embodiments have been described in connection with the
accompanying drawings. However, it should be understood that the
figures are not drawn to scale. Distances, angles, etc. are merely
illustrative and do not necessarily bear an exact relationship to
actual dimensions and layout of the devices illustrated. Components
can be added, removed, and/or rearranged. Further, the disclosure
herein of any particular feature, aspect, method, property,
characteristic, quality, attribute, element, or the like in
connection with various embodiments can be used in all other
embodiments set forth herein. Additionally, it will be recognized
that any methods described herein may be practiced using any device
suitable for performing the recited steps.
[0126] For purposes of this disclosure, certain aspects,
advantages, and novel features are described herein. It is to be
understood that not necessarily all such advantages may be achieved
in accordance with any particular embodiment. Thus, for example,
those skilled in the art will recognize that the disclosure may be
embodied or carried out in a manner that achieves one advantage or
a group of advantages as taught herein without necessarily
achieving other advantages as may be taught or suggested
herein.
[0127] Moreover, while illustrative embodiments have been described
herein, the scope of any and all embodiments having equivalent
elements, modifications, omissions, combinations (e.g., of aspects
across various embodiments), adaptations and/or alterations as
would be appreciated by those in the art based on the present
disclosure. The limitations in the claims are to be interpreted
broadly based on the language employed in the claims and not
limited to the examples described in the present specification or
during the prosecution of the application, which examples are to be
construed as non-exclusive. Further, the actions of the disclosed
processes and methods may be modified in any manner, including by
reordering actions and/or inserting additional actions and/or
deleting actions. It is intended, therefore, that the specification
and examples be considered as illustrative only, with a true scope
and spirit being indicated by the claims and their full scope of
equivalents.
[0128] Any methods disclosed herein need not be performed in the
order recited. The methods disclosed herein include certain actions
taken by a practitioner; however, they can also include any
third-party instruction of those actions, either expressly or by
implication. For example, actions such as "inserting a base plate
into a glenoid cavity" include "instructing insertion of a base
plate into a glenoid cavity."
* * * * *