U.S. patent application number 15/360455 was filed with the patent office on 2017-03-16 for guide for assisting with arrangement of a stock instrument with respect to a patient tissue.
The applicant listed for this patent is THE CLEVELAND CLINIC FOUNDATION. Invention is credited to Wael K. BARSOUM, Jason A. BRYAN, Joseph P. IANNOTTI.
Application Number | 20170071647 15/360455 |
Document ID | / |
Family ID | 44947213 |
Filed Date | 2017-03-16 |
United States Patent
Application |
20170071647 |
Kind Code |
A1 |
IANNOTTI; Joseph P. ; et
al. |
March 16, 2017 |
GUIDE FOR ASSISTING WITH ARRANGEMENT OF A STOCK INSTRUMENT WITH
RESPECT TO A PATIENT TISSUE
Abstract
A guide and a stock instrument in combination. The stock
instrument includes a guide interacting feature, a lower instrument
surface to abut the patient tissue and an upper instrument surface
for contacting the guide. The guide includes a guide body including
a lower guide surface and an upper guide surface. The lower guide
surface mates with the upper instrument surface of the stock
instrument when the lower instrument surface is in contact with the
patient tissue. The lower guide surface includes an instrument
guiding feature to mate with the guide interacting feature. An
orienting feature including an arm extends away from the upper
guide surface. The arm has a landmark engaging portion to enter a
predetermined relationship with a fixed landmark on the patient
tissue. The predetermined relationship indicates that the stock
instrument has achieved a predetermined instrument relationship
with the patient tissue.
Inventors: |
IANNOTTI; Joseph P.;
(Strongsville, OH) ; BARSOUM; Wael K.; (Bay
Village, OH) ; BRYAN; Jason A.; (Avon Lake,
OH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
THE CLEVELAND CLINIC FOUNDATION |
Cleveland |
OH |
US |
|
|
Family ID: |
44947213 |
Appl. No.: |
15/360455 |
Filed: |
November 23, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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14080855 |
Nov 15, 2013 |
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15360455 |
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13282528 |
Oct 27, 2011 |
9254155 |
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14080855 |
|
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61408376 |
Oct 29, 2010 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2090/3916 20160201;
A61B 17/1778 20161101; A61B 2034/107 20160201; A61B 17/8872
20130101; A61B 2034/108 20160201; A61B 17/88 20130101; A61B 34/10
20160201; A61B 17/1739 20130101 |
International
Class: |
A61B 17/88 20060101
A61B017/88; A61B 17/17 20060101 A61B017/17 |
Claims
1. A guide and a stock instrument in combination, the guide being
operable to arrange the stock instrument with respect to a patient
tissue, the guide and the stock instrument in combination
comprising: the stock instrument including at least one
guide-interacting feature, a lower instrument surface configured to
abut the patient tissue, and an upper instrument surface configured
to contact the guide; the guide including a guide body having a
lower guide surface and an upper guide surface spaced
longitudinally apart from the lower guide surface, the lower guide
surface being contoured to substantially mate with at least a
portion of the upper instrument surface of the stock instrument
when the lower instrument surface of the stock instrument is in
contact with the patient tissue, and the lower guide surface of the
guide including at least one instrument-guiding feature at a
predetermined feature location with respect to the guide body, the
instrument-guiding feature configured to mate with the
guide-interacting feature of the stock instrument such that the
guide and the stock instrument are disposed together in fixed
relative orientation and displaceable together as a guide assembly
when the instrument-guiding feature is engaged with the
guide-interacting feature, the upper guide surface of the guide
being accessible to a user when the lower guide surface of the
guide is in contact with the upper instrument surface of the stock
instrument; and wherein an orienting feature including an arm
extends away from the upper guide surface of the guide body of the
guide, the arm having a landmark-engaging portion configured to
enter a predetermined orienting relationship with a fixed landmark
disposed on the patient tissue while the lower guide surface of the
guide is in mating contact with at least a portion of the upper
instrument surface of the stock instrument in said fixed relative
orientation, the predetermined orienting relationship indicating
that the stock instrument has achieved a predetermined instrument
relationship with the patient tissue.
2. The combination of claim 1, wherein the orienting feature
includes an orienting indicator, and the orienting indicator
achieves a predetermined signaling relationship with the landmark
while the guide and stock instrument are engaged in the fixed
relative orientation to indicate that the stock instrument has
achieved a predetermined instrument relationship with the patient
tissue.
3. The combination of claim 1, further comprising a pin, the pin
comprising said fixed landmark and is adapted to be fastened in
place on the patient tissue.
4. The combination of claim 1, wherein the landmark-engaging
portion includes a notch formed in the arm of the orienting
feature, the notch being configured to receive the fixed landmark
at least partially therein.
5. The combination of claim 1, wherein one of the guide-interacting
feature of the stock instrument and the instrument-guiding feature
of the guide is a protrusion, and the other one of the
guide-interacting feature and the instrument-guiding feature is a
cavity, and the protrusion and the cavity are configured to mate
together to engage the guide and the stock instrument together in
said fixed relative orientation.
6. The combination of claim 1, wherein the guide is a
custom-manufactured guide configured for a specific patient.
7. The combination of claim 1, wherein the guide is a modified
stock guide, the modified stock guide being formed responsive to at
least one of preoperative imaging of the patient tissue and
preoperative selection of the stock instrument.
8. The combination of claim 1, wherein the stock instrument
includes at least one patient tissue-modification feature, the
patient tissue-modification feature indicating a predetermined
location for a patient tissue-modification procedure when the stock
instrument is in said predetermined instrument orientation with
respect to the patient tissue.
Description
RELATED APPLICATIONS
[0001] This application is a divisional of U.S. patent application
Ser. No. 14/080,855 filed Nov. 15, 2013, which is itself a
divisional of U.S. patent application Ser. No. 13/282,528 (now
issued U.S. Pat. No. 9,254,155 B2) filed Oct. 27, 2011, which
claims priority benefit from U.S. Provisional Application No.
61/408,376, filed Oct. 29, 2010, the subject matter of each of
which is incorporated herein by reference.
TECHNICAL FIELD
[0002] The present invention relates to a system and method for use
of a surgical guide and, more particularly, to a system and method
for use of a surgical guide for assisting with arrangement of a
stock instrument with respect to a patient tissue.
BACKGROUND OF THE INVENTION
[0003] The efficient functioning of the shoulder joints is
important to the well-being and mobility of the human body. Each
shoulder joint includes the upper portion of the humerus, which
terminates in an offset bony neck surmounted by a ball-headed
portion known as the humeral head. The humeral head rotates within
a socket, known as the glenoid fossa, in the scapula to complete
the shoulder joint. Diseases such as rheumatoid- and
osteo-arthritis can cause erosion of the cartilage lining of the
glenoid fossa so that the ball of the humerus and the scapula rub
together, causing pain and further erosion. Bone erosion may cause
the bones themselves to attempt to compensate for the erosion which
may result in the bone becoming deformed. This misshapen joint may
cause pain and may eventually cease to function altogether.
[0004] Operations to replace the shoulder joint with an artificial
implant are well-known and widely practiced. Generally, the
shoulder prosthesis will be formed of two components, namely: a
glenoid, or socket, component which lines the glenoid fossa, and a
humeral, or stem, component which includes a weight-bearing ball
and replaces the humeral head. (Each of these components may be
made up of multiple subassemblies.) Alternately, a reverse shoulder
prosthesis has a ball as the glenoid component and a socket as the
humeral component, but the following description presumes a
standard, not reverse, shoulder prosthesis arrangement. During the
surgical procedure for implanting the shoulder prosthesis, the
remaining cartilage or damaged tissue is removed from the glenoid
fossa using a reamer such that the native glenoid fossa will
accommodate the outer surface of the glenoid component of the
shoulder prosthesis. The glenoid component of the prosthesis can
then be inserted into the prepared glenoid fossa. Generally, fixing
means such as screws and/or bone cement may be used to hold the
glenoid component in the glenoid fossa. There is also generally an
implant stem provided to the glenoid implant, the stem being
inserted into a prepared cavity in the glenoid fossa to anchor the
glenoid implant. The use of additional fixing means and anchor(s)
helps to provide stability after the prosthesis has been inserted.
In some modern prosthesis, the glenoid component may be coated on
its external surface with a bone growth promoting substance which
will encourage bone ingrowth which also helps to hold the glenoid
component in place. The humeral head also is removed during the
surgical procedure, and the humerus shaft hollowed out using
reamers and rasps to accept the humeral component of the
prosthesis. The stem portion of the prosthesis is inserted into the
humerus and secured therein to complete the shoulder joint
replacement.
[0005] In order to strive toward desired performance of the
combined glenoid and humeral shoulder prosthesis components, the
glenoid portion should be properly positioned upon the glenoid
fossa (among other considerations). The glenoid portion positioning
is particularly important since incorrect positioning of the
glenoid component can lead to the prosthetic shoulder joint
suffering from dislocations, a decreased range of motion, and
possibly eventual loosening and/or failure of one or both
components of the joint.
[0006] Generally, the normal glenoid retroversion of a given
patient may fall within a range of approximately 20.degree.
(5.degree. of anteversion and 15.degree. of retroversion). (The
version of the glenoid is defined as the angle between the plane of
the glenoid fossa to the plane of the scapula body.) In the
pathologic state, glenoid bone loss may result in a much larger
range of version angles.
[0007] One goal of shoulder surgery may be to modify the pathologic
bone to correct pathologic version to be within the normal range or
the normal version of the patient's native anatomy before the bone
loss occurred. During surgery, and particularly minimally invasive
procedures, the plane of the scapula may be difficult or impossible
to determine by direct visual inspection, resulting in the need for
assistive devices or methods to define both the pathologic version
present at the time of surgery and the intended correction
angle.
[0008] It is generally believed that there is a preferred
orientation for the glenoid component to provide a full range of
motion and to minimize the risk of dislocation or other mechanical
component failure. Some example orientations of the glenoid
prosthesis relative to the glenoid face are about 5.degree. of
anteversion to about 15.degree. of retroversion; average version is
about 1-2.degree. of retroversion. This broadly replicates the
natural angle of the glenoid. However, the specific angular
orientation of the glenoid portion varies from patient to
patient.
[0009] With a view to overcoming these disadvantages, some
arrangements have been recently suggested in which a
three-dimensional intraoperative computer imaging surgical
navigation system is used to render a model of the patient's bone
structure. This model is displayed on a computer screen and the
user is provided with intraoperative three-dimensional information
as to the desired positioning of the instruments and the glenoid
component (or any component, depending on the subject patient
tissue) of the prosthetic implant. However, surgical navigation
arrangements of this type are not wholly satisfactory since they
generally use only a low number of measured landmark points to
register the patient's anatomy and to specify the angle of the
prosthetic implant component (e.g., a glenoid component), which may
not provide the desired level of accuracy. Further, the information
provided by such systems may be difficult to interpret and may even
provide the user with a false sense of security. Moreover, these
systems are generally expensive to install and operate and also
have high user training costs. Various proposals for trial
prosthetic joint components and assistive instruments have been
made in an attempt to overcome the problems associated with
accurately locating the glenoid portion of the prosthetic implant.
While these trial systems and instruments may help with checking
whether the selected position is correct, they are not well-suited
to specify the correct position initially, and thus there still is
user desire for a system which may assist a user in placement of
prosthetic implant component in a prepared native tissue site.
SUMMARY OF THE INVENTION
[0010] In an embodiment of the present invention, a method of
arranging a stock instrument with respect to a patient tissue is
described. The stock instrument includes at least one guide
interacting feature. A lower instrument surface of the stock
instrument is placed into contact with the patient tissue. A guide
having a lower guide surface contoured to substantially mate with
at least a portion of an upper instrument surface of the stock
instrument, an upper guide surface spaced longitudinally apart from
the lower guide surface by a guide body, and at least one
instrument guiding feature at a predetermined feature location with
respect to the guide body is provided. A predetermined instrument
orientation upon the patient tissue is defined. The predetermined
instrument orientation is preselected responsive to preoperative
imaging of the patient tissue. The lower guide surface is placed
into mating contact with at least a portion of the upper instrument
surface in a predetermined relative guide/instrument orientation
wherein at least one guide interacting feature of the instrument is
placed into engagement with at least one instrument guiding feature
of the guide. The guide is moved into a predetermined guide
orientation with respect to the patient tissue and concurrently the
instrument is moved into a predetermined instrument orientation
with respect to the patient tissue.
[0011] In an embodiment of the present invention, a guide for
assisting with arrangement of a stock instrument with respect to a
patient tissue is described. A lower guide surface is configured to
contact an upper instrument surface of the stock instrument when a
lower instrument surface of the stock instrument is in contact with
the patient tissue. The lower guide surface is contoured to
substantially mate with at least a portion of the upper instrument
surface. An upper guide surface is spaced longitudinally apart from
the lower guide surface by a guide body. The upper guide surface is
accessible to a user when the lower guide surface is in contact
with the upper instrument surface. An orienting feature is
configured to enter a predetermined orienting relationship with a
previously placed landmark while the lower guide surface is in
mating contact with at least a portion of the upper instrument
surface in a predetermined relative guide/instrument orientation.
The predetermined orienting relationship indicates that the
instrument has achieved a predetermined instrument relationship
with the patient tissue.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] For a better understanding of the invention, reference may
be made to the accompanying drawings, in which:
[0013] FIG. 1 is a perspective top view of an example use
environment;
[0014] FIG. 2 is a perspective bottom view of a first prior art
prosthetic component;
[0015] FIG. 3 is a perspective bottom view of a first prior art
instrument for use with the component of FIG. 2;
[0016] FIG. 4 is a top view of the instrument of FIG. 3;
[0017] FIG. 5 is a perspective bottom view of an embodiment of the
present invention;
[0018] FIG. 6 is a top view of the embodiment of FIG. 5;
[0019] FIG. 7 is a top view of the embodiment of FIG. 5 and the
instrument of FIG. 3 in the example use environment of FIG. 1;
[0020] FIG. 8 is a top view of a second prior art instrument for
use with the component of FIG. 2 or a similar component;
[0021] FIG. 9 is a perspective bottom view of the instrument of
FIG. 8;
[0022] FIG. 10 is a top view of an embodiment of the present
invention;
[0023] FIG. 11 is a bottom view of the embodiment of FIG. 10;
and
[0024] FIG. 12 is a top view of the embodiment of FIG. 10 and the
instrument of FIG. 8 in the example use environment of FIG. 1.
DESCRIPTION OF EMBODIMENTS
[0025] FIG. 1 depicts a portion of the external surface of a (left)
scapula 100, which is an example of a possible patient tissue use
environment for the described systems, apparatuses, and methods,
with particular emphasis on the glenoid fossa 102. Directional
arrow 104 indicates the superior/inferior and anterior/posterior
directions. A glenoid implant 206, shown in FIG. 2, is the stock
prosthetic implant for use with a prosthetic shoulder replacement
surgery for the described embodiments of the present invention. The
glenoid implant 206 includes an implant shaft 208, a lower implant
surface 210, an upper implant surface 212 (hidden in this view, as
shown via dashed line), and a plurality of fastening pegs 214
extending from the lower implant surface. The patient tissue is
shown and described herein at least as a scapula and the prosthetic
implant component is shown and described herein at least as an
glenoid prosthetic shoulder component, but the patient tissue and
corresponding prosthetic implant component could be any desired
types such as, but not limited to, hip joints, shoulder joints,
knee joints, ankle joints, phalangeal joints, metatarsal joints,
spinal structures, long bones (e.g., fracture sites), or any other
suitable patient tissue use environment for the present invention.
For example, the prosthetic implant component could be an internal
fixation device (e.g., a bone plate), a structure of a
replacement/prosthetic joint, or any other suitable artificial
device to replace or augment a missing or impaired part of the
body.
[0026] The term "lateral" is used herein to refer to a direction
indicated by directional arrow 104 in FIG. 1; the lateral direction
in FIG. 1 lies substantially within the plane of the drawing and
includes all of the superior, inferior, anterior, and posterior
directions. The term "longitudinal" is used herein to refer to a
direction defined perpendicular to the plane created by directional
arrow 104, with the longitudinal direction being substantially into
and out of the plane of the drawing in FIG. 1 and representing the
proximal (toward the medial line of the body) and distal (out from
the body) directions, respectively.
[0027] During installation of the glenoid implant 206, a shaft
aperture (not shown) is drilled into the patient tissue (here, the
patient's glenoid fossa 102) at a predetermined location and a
stock instrument is used to help prepare the patient tissue
surface. The stock instrument is depicted here as a glenoid
instrument 316 according to a first embodiment of the present
invention, shown in FIG. 3. Suitable instruments 316 similar to
those shown herein are available from DePuy Orthopaedics, Inc., of
Warsaw, Ind. The instrument 316 includes an instrument shaft 318, a
lower instrument surface 320, an upper instrument surface 322
(hidden in this view, as shown via dashed line), and at least one
guide interacting feature 324.
[0028] The term "stock" is used herein to indicate that the
component indicated is not custom-manufactured or -configured for
the patient, but is instead provided as a standard inventory item
by a manufacturer. A particular stock component may be selected by
the user from a product line range of available components, with
the user specifying a desired configuration, general or particular
size (e.g., small, medium, large or a specific measurement),
material, or any other characteristic of the component. Indeed, the
stock component could be manufactured only after the user has
selected the desired options from the range of choices available.
However, the stock component is differentiated from a
custom-manufactured or bespoke component in that the stock
component is agnostic and indifferent regarding a particular
patient anatomy during the design and manufacturing processes for
an implant intended for that patient, while the patient anatomy is
an input into at least one design and/or manufacturing process for
a custom-manufactured component. The following description presumes
the use of a stock instrument, though one of ordinary skill in the
art will be able to provide for the use of the present invention
with a custom-manufactured instrument, instead.
[0029] At least one of the guide interacting features 324 may bear
a direct positional relationship to some feature of the glenoid
implant 206. Here, the guide interacting features 324 are located
analogously to the fastening pegs 214 of the glenoid implant 206
and may later assist in guiding some aspect of patient tissue
modification to ready the glenoid fossa 102 for the glenoid implant
206 in a known manner and as will be discussed in further detail
below.
[0030] As can be seen in FIG. 4, the instrument 316 according to
the first embodiment of the present invention may include at least
one handling feature 426 to accept a handle (not shown) which the
user may manipulate to move the instrument at or near the surgical
site--two throughhole handling features and one closed (blind)
cavity handling feature are shown in the Figures. The instrument
316 may also include one or more securing features 428 for
assisting with holding the instrument 316 in a predetermined
instrument with the patient tissue, if desired.
[0031] During installation of the glenoid implant 206, it is known
for a user to place a stock instrument 316 on the patient tissue to
help guide surgical tools used to prepare the patient tissue to
receive the glenoid implant. For example, a central shaft aperture
(which will later receive the implant shaft 218) can be machined at
a desired location on the glenoid fossa 102, and the instrument
shaft 318 can be placed into the shaft aperture to help hold the
instrument 316 in place while the instrument is used as a template
for the user to drill, ream, cut, scrape, graft, or otherwise
modify the patient tissue from a native or pathologic state to
accept the glenoid implant 206 as desired according to the
preoperative plan and/or an intraoperative decision.
[0032] The shaft aperture can be located on the glenoid fossa 102
by the user with relatively little difficulty, such as with the
assistance of a landmark (not shown), such as a guide pin, wire,
marking, and/or other location indicator previously placed in a
predetermined relationship with the patient tissue. The landmark
may be any suitable two- or three-dimensional landmark such as, but
not limited to, a native or acquired anatomical feature of the
patient tissue and/or a separately provided landmark placed with
the assistance of a guide as disclosed in co-pending U.S. patent
application Ser. No. to be determined, filed Oct. 27, 2011, titled
"System and Method for Association of a Guiding Aid with a Patient
Tissue" and claiming priority to U.S. Provisional Patent
Application No. 61/408,359, filed Oct. 29, 2010 and titled "System
and Method for Association of a Guiding Aid with a Patient Tissue",
the entire contents of both of which are incorporated herein by
reference. The landmark could also or instead be placed using a
robotic surgical aid, adjustable reusable (e.g., "dial-in") tools,
intraoperative imaging, or any other suitable placement aid.
Optionally, an original landmark could have been previously placed,
then removed for any reason (e.g., to facilitate machining of the
glenoid fossa 102 surface). A second landmark may then be placed at
the same location and with the same location as the original
landmark, such as via reusing the cavity in the surface left by the
removal of the original landmark. Indeed, the remaining cavity in
the surface itself may serve a landmarking function. Through these
or any other such transformations of physical manifestations, the
position information represented by the original landmark and
preoperatively planned may be preserved and used during various
stages of the surgical procedure regardless of the way in which
that position landmark is made available to the user at those
various stages.
[0033] Once the shaft aperture is located as desired and the
instrument shaft 318 is inserted to substantially place the lower
instrument surface 320 in contact with the patient tissue of the
glenoid fossa 102, however, the instrument 316 may still be in an
orientation that does not comport with a preoperatively planned
positioning. Once the instrument shaft 318 is located inside the
shaft aperture, the instrument 316 can pivot about an axis provided
by the instrument shaft. For precision in pivoting the instrument
into a desired rotational orientation with respect to the glenoid
fossa 102, the user may choose to employ a guide 530, such as that
shown in FIGS. 5-7.
[0034] With reference to FIGS. 5-6, a guide 530 has a lower guide
surface 532 configured to contact an upper instrument surface 322
of the instrument 316 when a lower instrument surface 320 of the
instrument is in contact with the glenoid fossa 102. The lower
guide surface 532 is contoured to substantially mate with at least
a portion of the upper instrument surface 322, as will be discussed
below. The term "mate" is used herein to indicate a relationship in
which the contours of two structures are at least partially matched
or coordinated in at least two dimensions. For example, both the
lower guide surface 532 and the upper instrument surface 322 could
have profiles that are concavely curved, convexly curved,
planar/linear, or any combination of those or other profile shapes.
The guide 530 also includes an upper guide surface 634 spaced
longitudinally apart from the lower guide surface 532 by a guide
body 536. The upper guide surface 634 is accessible to a user when
the lower guide surface 532 is in contact with the upper instrument
surface 322.
[0035] The patient's name, identification number, surgeon's name,
and/or any other desired identifier may be molded into, printed on,
attached to, or otherwise associated with the guide 530 in a
legible manner. The guide 530 may be made by any suitable method
such as, but not limited to, selective laser sintering ("SLS"),
fused deposition modeling ("FDM"), stereolithography ("SLA"),
laminated object manufacturing ("LOM"), electron beam melting
("EBM"), 3-dimensional printing ("3DP"), contour milling from a
suitable material, computer numeric control ("CNC"), other rapid
prototyping methods, or any other desired manufacturing
process.
[0036] The guide 530 may include at least one instrument guiding
feature 538 at a predetermined feature location with respect to the
guide body 536. At least one guide interacting feature 324 of the
instrument 316 may be configured for engagement with at least one
instrument guiding feature 538 of the guide 530. As shown in FIG.
5, each instrument guiding feature 538 is a protrusion from the
lower guide surface 532 and each guide interaction feature 324 is a
cavity, and the protrusion enters the cavity to engage the guide
530 and the instrument 316 in the mating contact in the
predetermined relative guide/instrument orientation. However, one
of ordinary skill in the art could readily reverse that
cavity/protrusion status for one or more guide interacting features
324 and/or instrument guiding features 538, or could provide
different mechanical structures (i.e., other than a cavity or
protrusion) to carry out the described engagement.
[0037] As can be seen in FIG. 5, the lower guide surface 532
includes a hexagon-shaped protruding instrument guiding feature
538, which may be configured to engage with a correspondingly
located and complementarily shaped handling feature 426 of the
instrument 316 to supplement or supplant the engagement of the
round instrument guiding features in transferring motive force
between the guide 530 and the instrument 316. It is contemplated
that engagement between one or more guide interacting features 324
and instrument guiding features 538 will assist the user with
concurrently moving one of the guide 530 and the instrument 316 via
a motive force exerted on the other of the guide and the
instrument. Alternately, the user may directly grasp and move both
the guide 530 and the instrument 316 at once--in this situation,
the engagement between the guide interacting features 324 and
instrument guiding features 538 may simply assist with maintaining
the guide and the instrument in the predetermined relative
guide/instrument orientation. Here, the hexagonal instrument
guiding feature 538 is collinear with the handling feature 426,
which is collinear with the instrument shaft 318. Because the
instrument shaft 318 may interact with a shaft aperture in the
patient tissue serving as a landmark, the hexagonal instrument
guiding feature 538 could be considered to be an extension or
indication of the position of the landmark, as well. The hexagonal
edges of the centrally located instrument guiding feature 538 may
also be helpful in interacting with the hexagonal handling feature
426 of the instrument 316 to "grip" and transmit force (especially
rotational force) between the guide 530 and the instrument in a way
that the other, substantially cylindrical guiding features shown in
FIG. 5 might not be able to accomplish.
[0038] As depicted in FIG. 6, the guide 530 may include a handling
feature 426 which can be used with a handling tool (not shown)
similarly to, and potentially in combination with, the handling
features 426 of the instrument 316. Sometimes the available
maneuvering space in a surgical field is relatively restricted, and
it may be useful for a forceps, hex wrench (perhaps with a
frictional fit or other feature to nest into the handling feature
426), Kocher tool, hemostat, or other user-manipulated handling
tool (not shown) to selectively interact with the handling feature
to hold the guide 520 or instrument 316 steady and/or to move the
guide or instrument to a desired position. One or more features,
such as indents, apertures, cavities, lugs, undercuts, or any other
suitable structures could be provided to the handling feature 426
or to any other structure of the guide 530 or instrument 316 to
facilitate gripping of the guide by any handling tool, in general,
and/or by a particular handling tool.
[0039] An orienting feature 540, such as the depicted extension in
FIGS. 5-7, may be provided to the guide 530. As shown here, for use
with the instrument 316 in a glenoid implant 206 surgical
procedure, the orienting feature 540 may extend, perhaps
substantially, longitudinally and/or laterally from the guide 530,
but the direction, amount, and type of extension will depend upon
the location and type of body tissue with which the guide 530 is
being used. The orienting feature 540 may be configured to enter a
predetermined orienting relationship with a landmark (not shown),
such as a guide pin, wire, marking, and/or other location indicator
previously placed in a predetermined relationship with the patient
tissue, such predetermined orienting relationship occurring when
the lower guide surface 532 is in mating contact with at least a
portion of the upper instrument surface 322 in a predetermined
relative guide/instrument orientation. The achievement of the
predetermined orienting relationship indicates that the instrument
316 has achieved a predetermined instrument relationship with the
patient tissue. (The predetermined relative guide/instrument
orientation is achieved when the guide 530 and instrument 316 are
mated in a desired manner, as predetermined via preoperative
imaging and/or analysis.)
[0040] The landmark for use with the orienting feature 540,
similarly to any landmark used to help locate the shaft aperture as
described above, may be any suitable two- or three-dimensional
landmark and placed in any desired manner. It may be helpful for
the landmark for use with the orienting feature 540 to be affixed
to the patient tissue at a location spaced from a location of the
stock instrument 530.
[0041] Optionally, the orienting feature 540 may include an
orienting indicator 542. When present, the orienting indicator 542
may be configured to achieve a predetermined signaling relationship
(the signaling relationship being directly related to the orienting
relationship) with the landmark, as will be described below, while
the guide 530 and the instrument 316 are in the predetermined
relative guide/instrument orientation. For example, in the first
embodiment shown in FIGS. 5-7, the orienting feature 540 is a
arm-type structure extending from the guide body 536 and the
orienting indicator 542 is a notch in the orienting feature 540
shaped to somewhat closely surround at least a portion of the
diameter of a guide pin or other three-dimensional landmark to
achieve the predetermined signaling relationship. The landmark(s)
were previously placed in any suitable manner in predetermined
locations at the surgical site. Accordingly, the predetermined
signaling relationship between the landmark(s) and the orienting
indicator(s) 542 assists the user in placing the guide 530 into a
predetermined guide orientation with respect to the patient
tissue.
[0042] When the guide 530 and the instrument 316 are held in a
predetermined relative guide/instrument orientation (e.g., through
the use of the guide interacting feature 324 and instrument guiding
feature 538, frictional engagement between the upper instrument
surface 322 and lower guide surface 532, any other mechanical
linkage, or even merely coordinated movement of each by the user),
then the instrument is manipulated in concert with the guide.
Accordingly, movement of the guide 530 into the predetermined guide
orientation--as signaled by coordination of the landmark(s) and the
orienting feature 540--will concurrently move the instrument 316
into a predetermined instrument orientation with respect to the
patient tissue. One of ordinary skill in the art can readily
preoperatively plan the placement and type of landmark(s), as well
as the structure and type of orienting feature(s) 540 and/or
orienting indicator(s) 542 to assist the user in guiding the
instrument 316 into the predetermined instrument orientation and/or
location with respect to the patient tissue for a particular
application of the present invention.
[0043] While the orienting indicator 542 is shown in FIGS. 5-7 as
being a notch, any suitable structure, notch-like or otherwise,
could be used as an orienting indicator. For example, the orienting
indicator 542 could be a lug extending from the orienting feature
540, a visual indicator such as a line drawn or etched on the
orienting protrusion, or even a mechanical system such as a latch
or trip-wire.
[0044] Much of the success of a prosthetic joint replacement arises
from secure affixation of the glenoid implant 206 to the scapula
100, and anchoring of the fastening pegs 214 into robust bony
matter contributes to a suitably snug fit between the glenoid
implant and the scapula. However, pathological anatomy of the
scapula 100 may affect where the fastening pegs 214 can be securely
placed. The native and pathological anatomies differ from patient
to patient, so preoperative patient imaging scans may be used to
preoperatively plan desired locations and trajectories for the
fastening pegs 214 to be inserted into the scapula 100. However,
and particularly during minimally invasive surgeries, very little
of the scapula 100 may be visible to the user, and the visible
portion of the scapula may be located at the distal end of a
"tunnel" of surrounding soft tissue temporarily retracted by the
user--accordingly, available maneuvering space at the surgical site
may be severely restricted. In addition, the patient's shoulder may
be actually canted slightly differently during the surgical
procedure than planned preoperatively. These are among the factors
which may result in a preoperative plan for a particular glenoid
implant 206 installation being very difficult and time-consuming
for a user to actually perform in an operative environment.
[0045] To aid with carrying out a preoperative plan for attaching a
stock prosthetic implant to a patient tissue, the guide 530 may be
preoperatively generated. The guide 530 is at least partially
custom-manufactured for a particular patient responsive to
preoperative imaging of the patient tissue. For example, the guide
530 may be wholly custom-made (e.g., using rapid prototyping
techniques) or may be modified from a stock guide or guide blank
(not shown). It is contemplated that at least a part of the guide
530 is a patient-specific, single-use, bespoke feature suited only
for use at the indicated surgical site. For example, a stock guide
body 536 (e.g., the y-shaped portion of the structure in FIGS. 5-6)
could be supplemented with a patient-specific orienting feature 540
(e.g., the protruding, asymmetrical arm structure in FIGS. 5-6).
One of ordinary skill in the art could create a guide which uses a
patient-specific "disposable" structure connected to a stock,
generic "reusable" carrier in this manner, with any desired
attachment mechanism connecting the two in a sufficiently rigid
portion to carry out the interactions discussed herein.
[0046] Regardless of the whole/partial custom manufacture status,
the guide 530 may be configured responsive to at least one of
preoperative imaging of the patient tissue and preoperative
selection of the stock prosthetic implant. Because the instruments
316 are stock items, related to specific stock prosthetic implants
(e.g., the depicted glenoid implants 206), the guide 530 also may
be at least partially a stock item. The orientation of the
instrument 316 upon the glenoid fossa 102 is predetermined by a
user before the guide 530 is provided. This predetermination may
occur intraoperatively, as the user is able to directly see the
condition of the surgical site. However, it is contemplated that a
predetermination of the desired instrument orientation could be
accomplished preoperatively, with reference to preoperative imaging
of the patient tissue. In this manner, a user can create a patient
tissue model for observation, manipulation, rehearsal, or any other
pre-operative tasks.
[0047] The term "model" is used herein to indicate a replica or
copy of a physical item, at any relative scale and represented in
any medium, physical or virtual. The patient tissue model may be a
total or partial model of a subject patient tissue, and may be
created in any suitable manner. For example, and as presumed in the
below description, the patient tissue model may be based upon
computer tomography ("CT") data imported into a computer aided
drafting ("CAD") system. Additionally or alternatively, the patient
tissue model may be based upon digital or analog radiography,
magnetic resonance imaging, or any other suitable imaging means.
The patient tissue model will generally be displayed for the user
to review and manipulate preoperatively, such as through the use of
a computer or other graphical workstation interface.
[0048] During preoperative planning, the user can view the patient
tissue model and, based upon knowledge of other patient
characteristics (such as, but not limited to, height, weight, age,
and activity level), then choose a desired stock prosthetic
implant. Because three-dimensional image models are available of
many stock prosthetic implants, the user may be able to "install"
the stock prosthetic implant virtually in the patient tissue model
via a preoperative computer simulation. During such a simulation,
the user can adjust the position of the stock prosthetic implant
with respect to the patient tissue, even to the extent of
simulating the dynamic interaction between the two, to refine the
selection, placement, and orientation of the stock prosthetic
implant for a desired patient outcome. For example, a system
similar to that of co-pending U.S. patent application Ser. No. to
be determined, filed Oct. 26, 2011, titled "System of Preoperative
Planning and Provision of Patient-Specific Surgical Aids" and
claiming priority to U.S. Provisional Patent Application No.
61/408,392, filed Oct. 29, 2010 and titled "System of Preoperative
Planning and Provision of Patient-Specific Surgical Aids", the
entire contents of both of which are incorporated herein by
reference, or any suitable preoperative planning system could be
used.
[0049] Once a chosen stock prosthetic implant has been virtually
placed in a desired position and orientation with respect to the
patient tissue, the orientation of the implant, and thus of the
instrument 316, can also be planned through the use of the computer
simulation, with consideration of the location, amount, and
pathology of the patient tissue being taken into account in
instrument selection and placement planning. By hand and/or with
automatic computer assistance, the user can experiment with various
sizes, placements, and orientations for an instrument that can be
used to help achieve the desired patient tissue remodeling. For
example, the selected instrument 316 may contain at least one
patient tissue modification feature (e.g., a reaming window, drill
guide aperture, or any other structure which can help a user in
placing and/or conducting some patient tissue modification), which
indicates a predetermined location for a patient tissue
modification procedure when the instrument is in the predetermined
instrument orientation with respect to the patient tissue. In this
manner, the final desired location of the fastening pegs 214 in the
patient tissue, or any other patient tissue modification desired,
may be used to work backward and determine selection of a suitable
instrument 316 and from there to a predetermined instrument
orientation on the glenoid fossa 102, both in terms of lateral
positioning and rotational orientation.
[0050] When the instrument 316 positioning and selection has been
finalized in a virtual manner, the guide 530 can be generated, and
landmark(s) for interaction with the orienting feature 540
virtually placed with respect to the virtual instrument and the
virtual patient tissue. The user may then have the opportunity to
adjust the virtual guide 530 before a physical guide 530 is
produced. (Hereafter, in the description of the first embodiment,
the guide 530 is presumed to be physical.)
[0051] In FIG. 7, a scapula 100 is shown in an intraoperative
arrangement. Here, the instrument 316 has been placed atop the
glenoid fossa 102 with the instrument shaft 318 received into a
shaft aperture. A landmark 744 has been placed at a predetermined
landmark location chosen responsive to preoperative imaging of the
patient tissue. Here, the landmark 744 is spaced from a location of
the instrument 316.
[0052] The lower guide surface 532 of the guide 530 has been mated
with a portion of the upper instrument surface 322 of the
instrument 316 to place the instrument and guide into the
predetermined relative guide/instrument orientation. The guide 530
and instrument 316 have then been concurrently moved (either both
directly or by virtue of the interaction between some structure of
the guide and a contacting structure of the instrument) to place
the guide in the predetermined guide orientation with respect to
the patient tissue, which means, since the guide and instrument are
mated, that the instrument has achieved the predetermined
instrument orientation with respect to the patient tissue. The user
knows that the predetermined guide and instrument orientations have
been achieved because the mated guide 530 and instrument 316 have
been repositioned (here, rotated about the instrument shaft 318
pivotally held in the shaft aperture) to bring the orienting
feature 540 into the predetermined orienting relationship with the
landmark 744. More specifically in the depicted example of the
Figures, since the orienting indicator 542 is a notch, the
instrument 316 and mated guide 530 have been repositioned such that
the landmark 744 is received into the orienting indicator 542. As
an alternative to this agnostic placement of the guide 426 and
nested/attached stock prosthetic implant at the surgical site and
subsequent rotation into position, the guide 530 and the instrument
316 could be concurrently placed into contact with at least one
landmark (which could include the central landmark) at a location
spaced apart from the patient tissue at the surgical site. For
example, a landmark could be an elongate guide pin (such as that
shown in FIG. 7), and a notchlike orienting indicator 542 could be
placed into the signaling relationship with a protruding end of the
guide pin some distance from the patient tissue. In this optional
situation, the stock instrument would be guided into the
predetermined instrument orientation concurrently with being
brought into contact with the patient tissue as the orienting
indicator 542 slides along the length of the guide pin via a
rail-like dynamic guiding technique.
[0053] Regardless of how the goal of placing the instrument 316
into the predetermined instrument orientation with respect to the
patient tissue (glenoid fossa 102, here) is accomplished, the user
may remove the guide 530, and optionally the landmark 744, from the
surgical site and continue with the surgical procedure using the
positioned instrument as desired once the predetermined instrument
orientation has been achieved as shown in FIG. 7.
[0054] Optionally, the instrument 316 may be temporarily secured in
the predetermined instrument orientation to avoid shifting or
movement of the instrument upon the patient tissue. For example,
guide pins (not shown) could be inserted through the securing
features 428 to hold the instrument 316 in place for as long as
desired by the user. Whether an additional structure is provided or
the user merely holds the instrument 316 in place by hand, however,
the desired patient tissue modifications are made, the instrument
316 is removed from the patient tissue, and the surgical procedure
proceeds apace. This may include the insertion of one or more
surgical tools through at least one guide interacting structure 324
of the instrument 316, since some of the guide interacting
structures additionally function as drill guides for preparation of
the patient tissue to receive the fastening pegs 214 of the glenoid
implant 206 here.
[0055] FIGS. 8-12 depict a guide 530' according to a second
embodiment of the present invention and related structures. The
guide 530' of FIGS. 8-12 is similar to the guide 530 of FIGS. 5-7
and therefore, structures of FIGS. 8-12 that are the same as or
similar to those described with reference to FIGS. 1-7 have the
same reference numbers with the addition of a "prime" mark.
Description of common elements and operation similar to those in
the previously described first embodiment will not be repeated with
respect to the second embodiment.
[0056] FIGS. 8-9 depict an instrument 316' which can be used to
guide reaming or other relatively large-area patient tissue
modification (as opposed to the relatively confined fastening peg
214 drilling guided by the first embodiment). To that end, the
instrument 316' includes a relatively large guide interacting
feature 324'. For example, the instrument 316' of FIG. 8 could be
used with the glenoid implant 206 of FIG. 2 or with any other
suitable glenoid implant (e.g., a known type of implant having a
stepped lower implant surface, for which an area of the glenoid
fossa 102' will need to be reamed away).
[0057] Additionally, the instrument 316' of the second embodiment
does not have an instrument shaft 318, but instead has a locating
aperture 846 which accepts a three-dimensional landmark (not shown)
to position the instrument 316' laterally upon the glenoid fossa
102 as desired. The landmark which enters the locating aperture 846
could be a guidewire (not shown), such as that disclosed in
co-pending U.S. patent application Ser. No. 13/178,324, filed Jul.
7, 2011, titled "Method and Apparatus for Providing a Relative
Location Indication During a Surgical Procedure" and claiming
priority to U.S. Provisional Patent Application Ser. No.
61/362,722, filed Jul. 9, 2010, and titled "Method and Apparatus
for Providing a Relative Location Indication During a Surgical
Procedure", the contents of both of which are hereby incorporated
by reference in their entirety. The landmark (not shown) received
by the locating aperture 846 may have been previously placed to
provide a "pivot point" about which the instrument 316' can rotate
during guided movement as discussed below. This
landmarking/pivot-guiding function is provided instead by indirect
action of the instrument shaft 318 in the first embodiment of the
present invention, as previously discussed.
[0058] The lower instrument surface 320' of the instrument 316' of
the second embodiment also includes a plurality of holding teeth
948 which can be selectively pushed down into the patient tissue to
resist rotation/pivoting of the instrument about the landmark
within the locating aperture 846.
[0059] A guide 530' according to the second embodiment of the
present invention is shown in FIGS. 10-11. Like the instrument
316', the guide 530' includes a locating aperture 846. The guide
530' may include one or more handling features 426' (two shown),
which may be configured to accept a handling tool (not shown) or
otherwise to assist the user in moving the guide at or near the
surgical site.
[0060] In use, the guide 530' of the second embodiment operates
similarly to the guide 530 of the first embodiment, as is shown in
FIG. 12. The instrument 316' of FIGS. 10-11 is placed upon the
glenoid fossa 102 surface. Optionally, a landmark (not shown) may
have been previously placed in the glenoid fossa 102 surface--if
so, the locating aperture 846 receives the landmark as a part of
placing the lower instrument surface 320' in contact with the
patient tissue. The guide 530' is placed atop the instrument 316'
with the lower guide surface 532' in contact with the upper
instrument surface 322'. When present, the instrument guiding
features 538' of the guide 530' may mate with the guide interacting
features 324' of the instrument 316'.
[0061] Once the instrument 316' and guide 530' are mated together
in the predetermined relative guide/instrument orientation atop the
glenoid fossa 102' surface, the instrument and guide can be moved
concurrently to move both the guide and the instrument into
predetermined guide and instrument orientations with respect to the
patient tissue. In other words, engagement between the guide 530'
and the instrument 316' causes forces exerted upon the guide to be
transferred to the instrument, and the user can move both the
instrument and the guide concurrently either by moving just the
guide, or by moving both the guide and instrument directly. For
example, and presuming that the instrument 316' includes a locating
aperture 846 which accepts a landmark (not shown) placed in the
glenoid fossa 102' surface, a counterclockwise force (indicated by
counterclockwise arrow 1250 in FIG. 12) exerted upon the orienting
feature 540' will pivot the guide 530''--and thus the mated
instrument--about the landmark.
[0062] The guide 530' and mated instrument 316' may be rotated, for
example, until the orienting indicator 542' achieves a
predetermined signaling relationship with a landmark 744' such as
the depicted guide pin. Accordingly, the guide 530' can rotate the
instrument 316' into a predetermined instrument orientation with
respect to the glenoid fossa 102' surface.
[0063] When at least one landmark 744' (when present) is a guide
pin or other elongate three-dimensional structure, the guide pin
may deflect, if needed, to allow the guide 530' to be lifted
longitudinally off the protruding end guide pin. The guide 530' may
include at least one frangible portion to allow substantially
laterally-oriented removal of the guide from around the guide pin
or from engagement with the instrument 316'. As another option, the
guide 530' could include one or more slots (not shown) to allow
removal of the guide by sliding the guide sideways away from the
guide pin and/or the instrument 316'. The above description
presumes that the guide 530 and instrument 316 are removed from the
patient tissue before completion of the surgery. It is
contemplated, nevertheless, that the guide and/or a stock
instrument component could be configured for maintenance of the
guide and/or instrument within the body, perhaps as a part of the
completely installed prosthetic implant structure.
[0064] It is also contemplated that the guide 530 may be used in
conjunction with an implant and related structures such as those
discussed in co-pending U.S. patent application Ser. No. to be
determined, filed Oct. 27, 2011, titled "System and Method for
Assisting with Attachment of a Stock Implant to a Patient Tissue"
and claiming priority to U.S. Provisional Patent Application No.
61/408,324, filed Oct. 29, 2010 and titled "System and Method for
Assisting with Attachment of a Stock Implant to a Patient Tissue",
the entire contents of both of which are incorporated herein by
reference.
[0065] While aspects of the present invention have been
particularly shown and described with reference to the preferred
embodiment above, it will be understood by those of ordinary skill
in the art that various additional embodiments may be contemplated
without departing from the spirit and scope of the present
invention. For example, the specific methods described above for
using the guide 530 are merely illustrative; one of ordinary skill
in the art could readily determine any number of tools, sequences
of steps, or other means/options for placing the above-described
apparatus, or components thereof, into positions substantially
similar to those shown and described herein. Any of the described
structures and components could be integrally formed as a single
piece or made up of separate sub-components, with either of these
formations involving any suitable stock or bespoke components
and/or any suitable material or combinations of materials; however,
the chosen material(s) should be biocompatible for most
applications of the present invention. The mating relationships
formed between the described structures need not keep the entirety
of each of the "mating" surfaces in direct contact with each other
but could include spacers or holdaways for partial direct contact,
a liner or other intermediate member for indirect contact, or could
even be approximated with intervening space remaining therebetween
and no contact. Though certain components described herein are
shown as having specific geometric shapes, all structures of the
present invention may have any suitable shapes, sizes,
configurations, relative relationships, cross-sectional areas, or
any other physical characteristics as desirable for a particular
application of the present invention. An adhesive (such as, but not
limited to, bone cement) could be used in conjunction with the
system and method described herein. The guide 530 may include a
plurality of structures cooperatively forming the base body and
temporarily or permanently attached together in such a manner as to
permit relative motion (e.g., pivoting, sliding, or any other
motion) therebetween. Any structures or features described with
reference to one embodiment or configuration of the present
invention could be provided, singly or in combination with other
structures or features, to any other embodiment or configuration,
as it would be impractical to describe each of the embodiments and
configurations discussed herein as having all of the options
discussed with respect to all of the other embodiments and
configurations. An adhesive (such as, but not limited to, bone
cement) could be used in conjunction with the system and method
described herein. Any of the components described herein could have
a surface treatment (e.g., texturization, notching, etc.), material
choice, and/or other characteristic chosen to provide the component
with a desired interaction property (e.g., tissue ingrowth, eluting
of a therapeutic material, etc.) with the surrounding tissue. A
device or method incorporating any of these features should be
understood to fall under the scope of the present invention as
determined based upon the claims below and any equivalents
thereof.
[0066] Other aspects, objects, and advantages of the present
invention can be obtained from a study of the drawings, the
disclosure, and the appended claims.
* * * * *