U.S. patent application number 16/820373 was filed with the patent office on 2020-07-09 for spring-fit surgical guides.
The applicant listed for this patent is ConforMIS, Inc.. Invention is credited to Raymond A. Bojarski, Paul Dietz, Scott Doody, Steve Fraone, Martin J. Polinski.
Application Number | 20200214719 16/820373 |
Document ID | / |
Family ID | 53681886 |
Filed Date | 2020-07-09 |
United States Patent
Application |
20200214719 |
Kind Code |
A1 |
Fraone; Steve ; et
al. |
July 9, 2020 |
Spring-Fit Surgical Guides
Abstract
Various embodiments of devices, systems, and methods for
surgical procedures, including spring-fit guides for improved
guidance of surgical instruments, are disclosed.
Inventors: |
Fraone; Steve; (Brighton,
MA) ; Doody; Scott; (Melrose, MA) ; Dietz;
Paul; (Charlestown, MA) ; Polinski; Martin J.;
(Wrentham, MA) ; Bojarski; Raymond A.; (Attleboro,
MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ConforMIS, Inc. |
Billerica |
MA |
US |
|
|
Family ID: |
53681886 |
Appl. No.: |
16/820373 |
Filed: |
March 16, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15113304 |
Jul 21, 2016 |
10588639 |
|
|
PCT/US15/12199 |
Jan 21, 2015 |
|
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16820373 |
|
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|
61930873 |
Jan 23, 2014 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/1767 20130101;
A61B 17/1782 20161101; A61B 17/157 20130101; A61B 17/1742 20130101;
A61B 17/15 20130101; A61B 17/1764 20130101; A61B 17/155 20130101;
A61B 17/1739 20130101; A61B 2017/00526 20130101; A61B 17/1778
20161101 |
International
Class: |
A61B 17/15 20060101
A61B017/15; A61B 17/17 20060101 A61B017/17 |
Claims
1. A guide for a surgical instrument for use in treating a joint of
a patient, the guide comprising: a body having a guide slot
extending through at least a portion of the body from a first side
of the body to a second side of the body, wherein the guide slot is
dimensioned to receive the surgical instrument through an entrance
opening and guide the surgical instrument along a path extending
from an exit opening in a direction substantially opposite the
entrance opening and substantially along a predetermined cutting
plane, wherein the entrance opening is located on the first side of
the body and the exit opening is located on the second side of the
body, wherein a cutting-plane side wall of the guide slot includes
at least a portion substantially located within the cutting plane,
and wherein an opposing side wall of the guide slot is positioned
substantially opposite the cutting-plane side wall and includes at
least one spring-fit structure, the at least one spring-fit
structure comprising: a guide surface substantially facing the
cutting-plane side wall; and a flexing portion connected to the
body and supporting at least a portion of the guide surface, the
flexing portion configured to allow at least a portion of the guide
surface to move in a direction substantially away from the cutting
plane when the surgical instrument is inserted into the guide slot
and contacts at least a portion of the guide surface.
2. The guide of claim 1, wherein at least a portion of the guide
surface is substantially convex.
3. The guide of claim 1, wherein the opposing side wall includes a
substantially concave portion.
4. The guide of claim 1, wherein the opposing side wall includes a
substantially concave portion and wherein the concave portion is
positioned substantially opposite the spring-fit structure.
5. The guide of claim 1, wherein the spring-fit structure is
positioned adjacent to the entrance opening.
6. The guide of claim 1, wherein the body, the guide slot, and the
spring-fit structure comprise a single, unitary structure.
7. The guide of claim 1, wherein the at least a portion of the
cutting-plane side wall located within the cutting plane and the
spring-fit structure are formed of a polymer material.
8. The guide of claim 1, wherein the surgical instrument comprises
an instrument selected from the group consisting of a saw, a drill,
and a pin.
9. A system for treatment of a joint of a patient, the system
comprising: a first guide for a surgical instrument; and an implant
component to be implanted in the joint, wherein the first guide
comprises: a body having a guide slot extending through at least a
portion of the body from a first side of the body to a second side
of the body, wherein the guide slot is configured to receive the
surgical instrument through an entrance opening and guide the
surgical instrument along a path extending from an exit opening in
a direction substantially opposite the entrance opening and
substantially along a predetermined cutting plane, wherein the
entrance opening is located on the first side of the body and the
exit opening is located on the second side of the body, wherein a
cutting-plane side wall of the guide slot includes at least a
portion substantially located within the cutting plane, and wherein
an opposing side wall of the guide slot is positioned substantially
opposite the cutting-plane side wall and includes at least one
spring-fit structure, the at least one spring-fit structure
comprising: a guide surface substantially facing the cutting-plane
side wall; and a flexing portion connected to the body and
supporting at least a portion of the guide surface, the flexing
portion configured to allow at least a portion of the guide surface
to move in a direction away from the cutting plane when the
surgical instrument is inserted into the guide slot and contacts at
least a portion of the guide surface.
10. The system of claim 9, wherein the implant includes at least
one bone-facing surface and wherein the guide slot is configured to
guide a saw along the predetermined cutting plane such that a
resected surface of the joint is formed and configured to support
the at least one bone-facing surface of the implant.
11. The system of claim 9, wherein the implant includes at least
one bone-facing surface and wherein the guide slot is configured to
guide a saw along the predetermined cutting plane such that a
resected surface of the joint is formed that substantially
negatively matches the at least one bone-facing surface of the
implant.
12. The system of claim 9, wherein at least a portion of the guide
surface is substantially convex.
13. The system of claim 9, wherein the opposing side wall includes
a substantially concave portion.
14. The system of claim 9, wherein the opposing side wall includes
a substantially concave portion and wherein the concave portion is
positioned substantially opposite the spring-fit structure.
15. The system of claim 9, wherein the spring-fit structure is
positioned adjacent to the entrance opening.
16. The system of claim 9, wherein the body, the guide slot, and
the spring-fit structure comprise a single, unitary structure.
17. The system of claim 9, wherein the at least a portion of the
cutting-plane side wall located within the cutting plane and the
spring-fit structure are formed of a polymer material.
18. The system of claim 9, wherein the surgical instrument
comprises an instrument selected from the group consisting of a
saw, a drill, and a pin.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No.15/113,304, entitled "Spring-Fit Surgical Guides" and filed Jul.
21, 2016, which in turn is a U.S. national state entry under 35 USC
.sctn. 371 of International Application No. PCT/US15/12199,
entitled "Spring-Fit Surgical Guides" and filed Jan. 21, 2015,
which in turn claims the benefit of U.S. Provisional Application
No. 61/930,873, entitled "Spring-Fit Surgical Guides" and filed
Jan. 23, 2014. The disclosure of each of the above-described
applications is hereby incorporated herein by reference in its
entirety.
FIELD
[0002] The present teachings generally relate to surgical repair
systems (e.g., resection cut strategy, guide tools, and implant
components) as described in, for example, U.S. patent application
Ser. No. 13/397,457, entitled "Patient-Adapted and Improved
Orthopedic Implants, Designs And Related Tools," filed Feb. 15,
2012, and published as U.S. Patent Publication No. 2012-0209394,
which is incorporated herein by reference in its entirety. In
particular, the present teachings provide surgical tools, systems,
methods, and techniques incorporating features to facilitate
preparation of a patient's anatomical surfaces for installation of
implant components.
BACKGROUND
[0003] The natural anatomical joint structures of an individual may
undergo degenerative changes due to a variety of reasons, including
injury, osteoarthritis, rheumatoid arthritis, or post-traumatic
arthritis. When such damage or degenerative changes become far
advanced and/or irreversible, it may ultimately become necessary to
replace all or a portion of the native joint structures with
prosthetic joint components. Joint replacement is a well-tolerated
surgical procedure that can help relieve pain and restore function
in injured and/or severely diseased joints, and a wide variety of
prosthetic joints are well known in the art, with different types
and shapes of joint replacement components commercially available
to treat a wide variety of joint conditions.
[0004] As part of the surgical repair procedure, the underlying
anatomical support structures are typically prepared to receive the
joint implant components. For example, the placement of a femoral
implant component can typically involve preparation of the caudad
portion of the femoral bone (otherwise known as the distal head of
the femur). This may include surgical resection (e.g., cutting,
drilling, rongeuring, scraping) of portions of the medial and/or
lateral condyles of the femur, as well as the resection of other
anatomical features of the femur and/or surrounding soft tissues.
This preparation will desirably create an anatomical support
structure capable of accommodating and adequately supporting the
femoral implant component or components, which is ultimately
secured to the femur. Similar surgical steps can be performed to
the tibia and/or the patella, as well as other anatomical
structures, as necessary.
[0005] One or more surgical guide tools or jigs can be used to
assist the surgeon in preparing the underlying anatomical support
structure(s). There is a need, however, for improved surgical guide
tools and jigs to improve the accuracy, reproducibility, and/or
ease of preparing underlying anatomical support structure(s) for an
implant.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] FIG. 1 is a perspective view of a first exemplary guide slot
embodiment;
[0007] FIG. 2 is a cross-sectional view of the guide slot
embodiment of FIG. 1 in a plane substantially perpendicular to
entrance opening 108;
[0008] FIG. 3 is a perspective view of a second exemplary guide
slot embodiment;
[0009] FIG. 4 is a cross-sectional view of the guide slot
embodiment of FIG. 3 in a plane substantially perpendicular to
entrance opening 108;
[0010] FIG. 5 is a perspective view of a third exemplary guide slot
embodiment;
[0011] FIG. 6a is a cross-sectional view of the guide slot
embodiment of FIG. 5 in a plane substantially perpendicular to
entrance opening 108;
[0012] FIG. 6b is a cross-sectional view of the guide slot
embodiment of FIG. 5 in a plane substantially parallel to entrance
opening 108;
[0013] FIG. 7a is a perspective view of a fourth exemplary guide
slot embodiment;
[0014] FIG. 7b is a front view of the guide slot embodiment of FIG.
7a;
[0015] FIG. 8a is a perspective view of a fifth exemplary guide
slot embodiment;
[0016] FIG. 8b is a front view of the guide slot embodiment of FIG.
8a;
[0017] FIG. 9 is a perspective view of an exemplary embodiment of a
tibial jig;
[0018] FIG. 10a is a side view of the tibial jig embodiment of FIG.
9;
[0019] FIG. 10b is a cross-sectional view of upper portion 1260 of
the tibial jig embodiment of FIGS. 9 and 10a as indicated by C;
[0020] FIG. 10c is a cross-sectional view of upper portion 1260 of
the tibial jig embodiment of FIGS. 9 and 10a as indicated by D;
[0021] FIG. 11a is a front view of an exemplary embodiment of a
femoral jig; and
[0022] FIG. 11b is a cross-sectional view of the femoral jig
embodiment of FIG. 11a as indicated by B.
DETAILED DESCRIPTION
[0023] Reference will now be made in detail to the present
embodiments (exemplary embodiments) of the invention, examples of
which are illustrated in the accompanying drawings. Wherever
possible, the same reference numbers will be used throughout the
drawings to refer to the same or like parts. In this application,
the use of the singular includes the plural unless specifically
stated otherwise. Furthermore, the use of the term "including," as
well as other forms, such as "includes" and "included," is not
limiting. Also, terms such as "element" or "component" encompass
both elements and components comprising one unit and elements and
components that comprise more than one subunit, unless specifically
stated otherwise. Also, the use of the term "portion" may include
part of a moiety or the entire moiety. Any section headings used
herein are for organizational purposes only and are not to be
construed as limiting the subject matter described.
[0024] A variety of surgical guide tools can be used to assist
surgeons in preparing a joint for an implant. Some surgical guide
tools include guiding formations for receiving a surgical
instrument and guiding it along a desired path or plane. Such
guiding formations can comprise surfaces, slots, holes, apertures,
shielding elements, stops (e.g., depth stops), and/or any other
structures intended to direct and/or limit movement of a surgical
instrument. Often, surgical guides are referred to as captured or
uncaptured. A captured guide can be a guide that surrounds at least
a portion of three or more sides of a surgical instrument. For
example, a captured guide can comprise an aperture that can
completely surround a portion of a guide tool. A captured guide can
also comprise a slot having a U-shaped cross-section that can
surround a portion of a surgical instrument on all but the open
side. An uncaptured guide can comprise, for example, a single,
exposed surface, along which a surgical instrument can be moved.
The term "slot" will be used herein to generally identify a
captured guide. Any of the slot embodiments described below can
comprise one or more of various cross-sectional shapes (e.g.,
circular, square, rectangle, oblong, elliptical, U-shaped) and can
be configured to receive one or more of various different types of
surgical instruments (e.g., drill, saw, broach, pins, K-wires).
[0025] Typically, a guide slot has interior dimensions slightly
oversized relative to the dimensions of the surgical instrument it
is intended to receive. This may be done to, for example, ease
insertion, accommodate manufacturing
tolerances/variances/minimum-feature-sizes, and/or accommodate
dimensional changes based on, for example, environmental factors
and/or properties of the guide material. Such oversizing of guide
slots can, however, have undesirable effects, such as, for example,
permitting unintended lateral movement of the surgical instrument
relative to the longitudinal axis of insertion of the instrument
within the guide slot (e.g., skiving of a saw blade), deviation of
the surgical instrument from a predetermined cutting plane, and/or
other unintended movement of the surgical instrument, resulting in
a reduction in accuracy of placement of the surgical instrument
within the tissue of interest. In some cases, various of the
undesirable effects described above associated with oversizing of
slots can also be caused, at least in part, by inherent flexibility
of the guide slot due to structural and/or material properties of
the body of the slot.
[0026] As an example, currently, some surgical guides are
manufactured using a selective laser sintering (SLS) process with a
polymer powder material to produce a unitary surgical guide,
including one or more guide slots, formed of nylon. In some cases,
due to limitations of the SLS manufacturing process and/or inherent
flexibility of the nylon body, guide slots with typical all-flat
surfaces in such devices may allow for a certain amount of
undesired movement (e.g., skiving of a saw blade) within the slot
during use.
[0027] Various embodiments of surgical guides disclosed herein
include a guide slot having a spring-fit structure, which can
provide improved guidance of surgical instruments relative to a
typical guide slot, as discussed above. Generally, a spring-fit
structure, as disclosed herein, can include one or more guiding
surfaces, which may be supported, at least in part, by one or more
flexing or spring portions. As used herein, a "flexing" portion or
structure can include one or more springs and/or may comprise a
structure capable of flexing due to the inherent properties of the
material forming the structure, or a portion thereof, and the
shape/dimensions of the structure. The flexing portion can be
configured to enable the guiding surface to engage a surgical
instrument inserted into the slot and move in order to accommodate
and/or form fit the surgical instrument. The flexing portions may
also enable the guiding surface(s) to apply one or more forces to
the surgical instrument in one or more direction(s) generally
perpendicular to the direction of insertion of the instrument, and
thereby improve desired engagement of the instrument with various
guiding surfaces of the slot and/or provide resistance to
deviations of the surgical instrument from a predetermined cutting
plane.
[0028] As illustrated by the various embodiments described below, a
variety of spring-fit structures can be utilized with a guide slot.
Further, in some embodiments, a spring-fit structure may form a
portion (e.g., a side wall) of the slot itself. Additionally or
alternatively, a spring-fit structure may be added to a slot or
positioned adjacent to a slot. In some embodiments, a spring-fit
structure may be integrally formed with a corresponding guide slot
(e.g., a spring-fit structure and a corresponding guide slot may be
unitary, having been formed in the same manufacturing process, such
as, for example, a printing run of a 3-D printing apparatus). In
other embodiments, a spring-fit structure may be a modular
component, which is configured to be joined with a guide slot. In
various embodiments, a guide slot and a spring-fit structure and/or
a guide slot including a spring-fit structure can be incorporated
into the body of a surgical guide. In some embodiments, a guide
slot and a spring-fit structure may be integrally formed with the
body of a surgical guide (e.g., a guide slot, a spring-fit
structure, and a body of a surgical guide may be unitary, having
been formed in the same manufacturing process, such as, for
example, a printing run of a 3-D printing apparatus).
Alternatively, a guide slot and spring-fit structure can comprise
one or more modular components that can be joined with the body of
a surgical guide.
[0029] FIGS. 1 and 2 depict an exemplary embodiment of a guide slot
100 that includes a spring-fit structure 102a. In various
embodiments, guide slot 100 can extend from the front side 104 to
the rear side 106 of the body of a surgical guide. Slot 100 can
receive a surgical instrument through entrance opening 108, and
after passing through slot 100, the surgical instrument, or at
least a portion of the surgical instrument, may exit slot 100
through exit opening 110, optionally, traveling substantially along
predetermined cutting plane 112. Predetermined cutting plane 112
can be a specific plane along which the surgical guide and slot are
designed to direct a surgical instrument into tissue to be cut. The
boundaries of the interior of slot 100 may be defined, at least in
part, by a cutting-plane side wall 114 and an opposing side wall
116, which is located substantially on the opposite side of the
slot from cutting-plane side wall 114. One or more portions of
cutting-plane side wall 114 (e.g., portion 118a, 188b, 118c) can be
positioned and/or oriented substantially within the predetermined
cutting plane 112. In various embodiments, the portions of the side
wall within the predetermined cutting plane may comprise surfaces
intended to contact and guide the surgical instrument, such that
the surgical instrument ultimately travels substantially parallel
thereto and thus along the predetermined cutting plane, as the
instrument passes through the exit opening 110 of the slot 100 and
into tissue to be cut. One or more spring-fit structures 102 (see,
e.g., 102a) may be included, for example, in opposing side wall
116.
[0030] As mentioned above, the one or more spring-fit structures
102 can be configured to engage with and apply a force to the
surgical instrument passing through slot 100. For example,
spring-fit structure 102a can include a guide surface 120a and a
flexing portion 122a, which supports guide surface 120a with
respect to the body of the guide and can be substantially
positioned between guide surface 120a and the body of the guide.
Guide surface 120a can substantially face the cutting-plane side
wall 114 and be positioned such that at least a portion of guide
surface 120a can contact a surgical instrument passing through slot
100. As the surgical instrument is inserted into slot 100 and
engages guide surface 120a, a force may be applied by the
instrument to guide surface 120a, and flexing portion 122a may flex
in response to the applied force, thereby allowing at least a
portion of guide surface 120a to move substantially away from
cutting-plane side wall 114 and permit the surgical instrument to
travel therebetween. In some embodiments, the spring-fit structure
may flex so as to form-fit the surgical instrument. Guide surface
120a can apply to the surgical instrument a force directed, for
example, substantially towards the cutting-plane side wall 114. The
force applied to the surgical instrument may, for example, provide
improved consistency and/or stability of contact between the
surgical instrument and one or more portions of the cutting-plane
side wall 114, such as, for example, portions within the
predetermined cutting plane 112 (e.g., 118a, 118b) and/or may
provide resistance to the surgical instrument deviating from
predetermined cutting plane 112.
[0031] As will be appreciated, in various embodiments, the flexing
or spring portion of the spring-fit structures can incorporate a
variety of spring-type structures or shapes, such as, for example,
that of a coil spring, helical spring, cantilever spring, leaf
spring, flat spring, and/or machined spring. For example, in some
embodiments, the spring-fit structure can comprise a cantilevered
leaf spring configuration, as shown in FIGS. 1 and 2. Accordingly,
in some embodiments, guide surface 120a may comprise a surface of
the flexing portion 122a, or a portion thereof. Optionally, a
recess may be formed in the opposing side wall 116 to accommodate
one or more portions of the spring-fit structure 120a and/or
movement of one or more portions of the spring-fit structure 120a
when engaged by a surgical instrument. Also optionally, some
embodiments can include one or more additional openings 126, which
can, for example, provide a channel(s) that facilitates removal of
manufacturing material (e.g., unfused powder in the case of an SLS
manufacturing process) and/or facilitate heat dissipation during
use. In some embodiments, guide surface 120a, or at least a portion
thereof, can be substantially convex in at least one plane. A
convex guide surface may reduce contact area between the surgical
instrument and spring-fit structure 102a, and may thereby reduce
friction and heat generation associated with engagement of the
surgical instrument with spring-fit structure 102a. Alternatively
or in addition, in some embodiments, guide surface 120 may include
one or more substantially straight portions (e.g., 120b of FIG. 4)
and/or include one or more concave portions. Furthermore, some
embodiments may include multiple flexing portions 122 and/or
multiple guide surfaces 120. For example, FIGS. 3 and 4 depict an
embodiment of slot 100 that includes first flexing portion 122b and
first guide surfaces 120b and also includes second flexing portion
122c and second guide surfaces 120c.
[0032] Additionally or alternatively, in some embodiments, a guide
surface 120d (or at least a portion thereof) can be a substantially
flat surface oriented substantially parallel to predetermined
cutting plane 112 and supported by one or more flexing portions
122d, which connect guide surface 120d to the body of the guide, as
shown, for example, in FIGS. 5, 6a, and 6b. For example, flexing
portions 122d can comprise struts positioned oblique to guide
surface 120d in at least one plane (e.g., a plane substantially
transverse to predetermined cutting plane 112, as can be seen in
FIG. 6b, which depicts a cross-section of the slot of FIGS. 5 and
6a in a plane transverse to cutting plane 112 and an axis
connecting entrance opening 108 and exit opening 110). Flexing
potion(s) 122d can comprise alternative spring structures, such as,
for example, a coil spring, a helical spring, etc. In some
embodiments, flexing portion(s) 122d may be integrally formed with
guide surface 120d, while in other embodiments the components may
be modular.
[0033] Additionally or alternatively, in some embodiments one or
more flexing portions can comprise at least a portion of a sidewall
of slot 100. For example, in some embodiments, one or more
sidewalls of slot 100 can comprise a tension spring structure, such
as, for example, an accordion-type spring structure 122e (depicted
in FIGS. 7a and b) or a flexible curved or loop structure 122f (as
depicted in FIGS. 8a and b). In some such embodiments, slot 100 may
be dimensioned such that a distance between guide surface 120e and
at least a portion of a surface 118d of cutting-plane side wall 114
is less than a width and/or a kerf of a surgical instrument to be
inserted through slot 100. Accordingly, in some embodiments, the
one or more flexing portions incorporated into sidewall(s) of slot
100 can allow for slot 100 to expand (e.g., between guide surface
120e and side wall 114) upon insertion of the surgical instrument
to form fit the slot to the surgical instrument.
[0034] In various embodiments, one or more dimensions, properties,
and/or parameters associated with one or more spring-fit structures
can be varied to achieve a desired guidance provided by the slot to
a surgical instrument and/or based on material properties of
portions of the spring-fit structure. For example, the working
length of a flexing or spring portion may be selected or designed
such that the guide surface will be able to move to a desired
maximum distance without the flexing or spring portion yielding.
Similarly, the thickness of a flexing or spring portion may be
selected to be thick enough to provide a desired minimum strength
and/or resistance to movement, but thin enough to flex without
material yielding. In some embodiments, the flexing or spring
portion may have a uniform thickness throughout the working length.
Alternatively, the flexing or spring member may have a non-uniform
thickness, such as, for example, a tapered thickness, which may
provide more uniform stress concentrations during bending.
Additionally or alternatively, in some embodiments, one or more
portions of the spring-fit structure may be filleted, such as, for
example, at junctures where the flexing portion connects to the
body of the guide. Such fillets may reduce stress at particular
locations. Additionally or alternatively, the elasticity and/or
resistance associated with a flexing or spring portion may be
selected, designed, and/or modified using materials and processes
known in the art. For example, various types and/or combinations of
polymers and polymer manufacturing techniques, as discussed further
below, can be used to make a spring-fit structure with a desired
elasticity and/or resistance.
[0035] Furthermore, the location of one or more spring-fit
structures relative to the slot 100 can be varied to achieve
desired guidance characteristics provided by the slot to a surgical
instrument and/or based on material properties of portions of the
spring-fit structure. For example, a spring-fit structure, such as
spring-fit structure 102a, may be positioned relatively close or
adjacent to entrance opening 108 of slot 100. This positioning may
provide for easier insertion of the surgical instrument into slot
100 and/or may provide more resistance (e.g., relative to a
spring-fit structure positioned closer to exit opening 110) to
deviation of portions of the surgical instrument through and/or
below the predetermined cut plane 112 after exiting slot 100. In
cases where the surgical instrument comprises a saw, deviation of
portions of the saw blade through and/or below predetermined cut
plane 112 may result in overcutting (e.g., resecting more tissue
than intended, cutting tissue at a greater depth than intended).
Additionally or alternatively, positioning a spring-fit structure
102 relatively close or adjacent to exit opening 110 of slot 100
may provide increased resistance to deviation of portions of the
surgical instrument upwards and/or away from predetermined cut
plane 112. In some embodiments a slot 100 may include a first
spring-fit structure proximate to entrance opening 108 and a second
spring-fit structure proximate to exit opening 110. Additionally or
alternatively, some embodiments of slot 100 can include a
spring-fit structure positioned substantially equidistant from
entrance opening 108 and exit opening 110.
[0036] Various embodiments may further include in the side walls of
slot 100 one or more substantially concave portions, scallops,
indentations, or other surface features that provide additional
space or clearance along a particular portion of a side wall. For
example, as depicted in FIGS. 1 and 2, some embodiments can include
a substantially concave portion (hereafter referred to as a
"scallop") 124 in cutting-plane side wall 114. Scallop 124 may be
positioned substantially adjacent to or opposite spring-fit
structure 102a. In such embodiments, scallop 124 may reduce or
eliminate undesired scraping (e.g., by a cutting edge of a saw) of
a portion of spring-fit structure 102a (e.g., guide surface 120a)
as the surgical instrument passes through slot 100. Optionally, in
some embodiments, scallop 124 may be designed based on a width
and/or a kerf (e.g., of a saw blade) of a surgical instrument.
Additionally or alternatively, some embodiments may include a
scallop that is positioned substantially offset from spring-fit
structure 102. In various embodiments, the incorporation of one or
more scallops may reduce contact area between the surgical
instrument and slot 100, and may thereby reduce friction and heat
generation associated with passing the surgical instrument through
slot 100.
[0037] Jigs and/or guide slots described herein may include slots
that are dimensioned to accommodate various cutting tools and/or
manufacturing materials and/or tolerances. For example, a guide
slot may be designed for a saw blade with a body thickness of 1.10
mm and a saw blade kerf of 1.3 mm. A guide slot may be made using
an SLS process with a manufacturing tolerance of .+-.0.3 mm. An
exemplary guide slot embodiment intended to accommodate these
parameters and utilizing a spring-fit structure comprising a
curved, cantilevered leaf spring (as illustrated in FIGS. 1 and 2)
can include entrance and exit opening depths (i.e., dimension
orthogonal to the cutting plane) of 1.6 mm, a minimum depth between
the guide surface of the leaf spring (in uncompressed state) and
the cutting plane of 1.0 mm, and a maximum depth between the
cutting plane and the surface of the scallop of 0.6 mm.
[0038] Various embodiments disclosed herein include systems,
methods, and devices for performing a series of bone cuts to
receive a patient-adapted implant. Specifically, a set of jigs can
be designed in connection with the design of a patient-adapted
implant component. The designed jigs can guide the surgeon in
performing one or more patient-adapted cuts to the bone so that
those cut bone surface(s) negatively-match patient-adapted
bone-facing surfaces of corresponding patient-adapted implant
components.
[0039] Spring-fit guide slots (i.e., guide slots with spring-fit
structures, such as, for example, andy of the embodiments described
above) can be incorporated into a variety of surgical guide tools,
including, for example, those disclosed in U.S. patent application
Ser. No. 13/397,457, entitled "Patient-Adapted and Improved
Orthopedic Implants, Designs And Related Tools," filed Feb. 15,
2012, and published as U.S. Patent Publication No. 2012-0209394
and/or those disclosed in International Application No.
PCT/US2013/025216, entitled "Joint Arthroplasty Devices, Systems,
and Methods," filed Feb. 7, 2013, and published as International
Publication No. WO2013/119865, which is incorporated herein by
reference in its entirety. For example, spring-fit guide slots can
be incorporated into, or in place of, captured cutting guide slots,
uncaptured cutting guide surfaces, and/or guide holes/apertures
(e.g., for guiding drills, pins, etc.). Further, spring-fit guide
slots can be incorporated into patient-specific guide tools, as
well as standard (i.e., not patient-specific) guide tools. Several
exemplary embodiments of surgical repair systems and surgical guide
tools incorporating one or more spring-fit guide slots are
described in further detail below.
[0040] Various embodiments of surgical repair systems can include
implants and procedures where the implant has an inner, bone-facing
surface and an outer, joint-facing surface, and the inner,
bone-facing surface engages an articular surface (and/or
surgically-prepared tissue surface(s) proximate to locations where
at least a portion of tissue comprising an articular surface has
been resected) of a first biological structure (e.g., bone or
cartilage) at a first interface. The articular surface can be a
native surface, a cut surface, a preexisting implant component
and/or various combinations and/or quantities/distributions thereof
(e.g., multiple cut planes separated by a region of natural
subchondral bone and/or articular cartilage). In addition, an
outer, joint-facing surface of one implant component can oppose a
second, outer joint-facing surface on an opposing joint implant
component at a joint interface. In certain embodiments, one or more
features of the implant component, for example, various inner,
bone-facing surfaces and/or various outer, joint-facing surfaces
can be patient-adapted (i.e., comprising one or more
patient-specific and/or patient-engineered features).
[0041] Some embodiments of surgical repair systems can include the
use of a guide tool having at least one patient-specific
bone-facing surface portion that substantially negatively-matches
at least a portion of a biological surface at the patient's joint.
The guide tool further can include at least one aperture or slot
for directing movement of a surgical instrument (e.g., securing
pin, cutting tool). One or more of the slots can be designed to
guide the surgical instrument to deliver a patient-optimized
placement for, for example, a securing pin or resection cut. In
addition or alternatively, one or more of the slots can be designed
to guide the surgical instrument to deliver a standard placement
for, for example, a securing pin or resection cut. As used herein,
"jig" also can refer to guide tools, for example, to guide tools
that guide resectioning of a patient's biological structure.
[0042] FIGS. 9 and 10a-c depict views of an exemplary embodiment of
a tibial jig 1200 that can be used for preparing a proximal tibia
to receive one or more implant components. In some embodiments,
tibial jig 1200 can include one or more surfaces designed and/or
selected to accommodate and/or conform to various anatomical
features and/or surfaces of the underlying tibial anatomy. For
example, tibial jig 1200 can include a substantially
posterior-oriented or facing surface 1210 and one or more
caudad-oriented or capping surfaces 1220 and 1230 formed on
projections 1240 and 1250 that extend from an upper portion 1260 of
the tibial jig 1200. Surface 1210 can be designed based on
patient-specific information to have a shape to substantially
conform to and/or negatively match an anterior-facing portion of
the tibial head when positioned against it, with the capping
surfaces 1220 and 1230 conforming to and/or negatively matching
corresponding subchondral bone surfaces of the proximal tibia (not
shown). When properly positioned on the tibia in conforming
alignment, this arrangement and placement can result in alignment
of the tibial jig 1200 in a known position and/or orientation.
[0043] In some embodiments, tibial jig 1200 can further include one
or more slots 1205, 1270, 1280 and 1290, which can be configured to
guide insertion of surgical instruments (e.g., one or more cutting
or drilling instrument, alignment pins, wires) into the tibia to
cut, align, and/or secure the jig (or various other tools) to the
tibia. For example, in some embodiments, tibial jig 1200 can
include a slot 1205 that is configured to guide a surgical cutting
tool in resection of the proximal tibia along a cutting plane
having a predetermined position and orientation when jig 1200 is
positioned in conforming alignment with the proximal tibia. The
predetermined cutting plane may have a position and orientation
such that the resulting cut tibia is configured to receive a tibial
implant component (e.g., a patient adapted implant component, a
standard implant component). Slot 1205 can be designed to
incorporate a spring-fit structure, such as, for example, any one
or more of the embodiments described above, to enhance guidance of
the surgical instrument. For example, slot 1205 can include a
spring fit structure 102f, which comprises a cantilevered leaf
spring configuration (e.g., similar to that shown in FIGS. 1 and
2), as illustrated in FIG. 10b. In some embodiments, a leaf spring
component of spring-fit structure 102f can be substantially curved
(e.g., as depicted in FIG. 10c) in a plane substantially parallel
to the cutting plane of slot 1205 to substantially follow the
curvature of a portion of the body of jig 1200 and/or of an
entrance opening 1206 of slot 1205. Additionally, in some
embodiments, an exit opening 1207 of slot 1205 may be located
within patient-specific surface 1210.
[0044] FIGS. 11a and b depict views of an exemplary embodiment of a
femoral jig 1310 that can be used for preparing a distal femur to
receive one or more implant components. Femoral jig 1310 can
include one or more surfaces 1315 configured for placement on one
or more distal cut planes formed on the distal femur. One or more
portions of the perimeter of femoral jig 1310 can optionally be
shaped to substantially align with respective portions of the
perimeter of the resected distal femur. Femoral jig 1310 can
further include one or more guide slots, such as, for example,
drill and/or pin holes 1320a-d, which can be configured to guide
and/or receive one or more pins inserted into and/or extending from
the cut femur and which may be used for alignment and/or securement
of femoral jig 1310 with respect to the femur. Optionally, femoral
jig 1310 can include drill guides 1345 and 1350 that can be
employed to form a medial bore and a lateral bore in the resected
distal surface of the femur to accommodate pegs or anchors of the
femoral implant component(s).
[0045] Additionally or alternatively, femoral jig 1310 can include
one or more guide slots for guiding surgical cutting tools in
resection of various portions of the femur. For example, femoral
jig 1310 can include an anterior guide slot 1325 that is configured
to guide a saw in creating an anterior bone cut on the distal
femur. Femoral jig 1310 may also include a medial posterior guide
slot 1330 and a lateral posterior guide slot 1335, configured to
guide a saw in creating a posterior bone cut on the medial and
lateral condyles, respectively, of the distal femur. Femoral jig
1310 may further include an anterior chamfer guide slot 1340,
configured to guide a cutting saw in creating an anterior chamfer
bone cut on the distal femur. Each of the resulting bone cuts may
correspond to, negatively match, and/or be configured to receive a
respective bone-facing surface of a femoral implant component. Each
of the guide slots may be a partially captured slot (e.g., medial
and lateral posterior guide slots 1330 and 1340, as depicted in
FIG. 11a) or a fully captured slot (e.g., anterior guide slot 1325
and anterior chamfer guide slot 1340 as depicted in FIG. 11a).
Furthermore, one or more of the guide slots 1325, 1330, 1335, and
1340 can be designed to incorporate a spring-fit structure, such
as, for example, those discussed above. For example, in some
embodiments, each of slots 1325, 1330, 1335, and 1340 can include a
spring-fit structure 102a, which comprises a cantilevered leaf
spring configuration (e.g., similar to that shown in FIGS. 1 and
2), as illustrated in FIG. 11b.
[0046] In various embodiments, the slots in a particular guide tool
can be substantially horizontal, substantially diagonal, or
substantially vertical, for example, as compared to the patient's
mechanical axis and/or anatomical axis. Moreover, one or more of
the resection cut slots can allow for a complete resection cut or a
partial resection cut, e.g., scoring of the patient's bone to
establish a resection cut that can be finished after removing the
tool. This approach can be advantageous by allowing for faster
resection in the absence of the guide tool. Moreover, one or more
resection cut slots can include a blade-depth or drill-depth stop.
This is particularly useful for step resection cuts, for example,
vertical step resection cuts, that connect two facets or planes of
a resected surface.
[0047] While some exemplary embodiments provided above are
generally described with respect to treatment of a knee joint,
various aspects and embodiments disclosed herein can equally be
applied to treatment of any anatomical feature and/or joint. For
example, various embodiments of the guide tools, guide slots,
and/or spring-fit structures disclosed herein can be configured for
use in treatment of any particular joint, including, without
limitation, a spine, spinal articulations, an intervertebral disk,
a facet joint, a shoulder, an elbow, a wrist, a hand, a finger, a
hip, a knee, an ankle, a foot, or a toe joint. This can include
patient-adapted and/or standard guide tools that incorporate one or
more spring-fit guide slots. Likewise, methods of designing (e.g.,
designing and making) and/or using the guide tools, guide slots,
and/or spring-fit structures, as described herein, as well as
associated implant components, can be applied to treatment of any
anatomical feature or joint.
[0048] The step of designing an implant component and/or guide tool
(including one or more slots with spring-fit structures) as
described herein can include both configuring one or more features,
measurements, and/or dimensions of the implant and/or guide tool
(e.g., derived from patient-specific data from a particular patient
and adapted for the particular patient) and manufacturing the
implant and/or guide tool. In certain embodiments, manufacturing
can include making the implant component and/or guide tool from
starting materials, such as, for example, metals and/or polymers or
other materials in solid (e.g., powders or blocks) or liquid form.
In addition or alternatively, in certain embodiments, manufacturing
can include altering (e.g., machining) an existing implant
component and/or guide tool, for example, a standard blank implant
component and/or guide tool or an existing implant component and/or
guide tool (e.g., selected from a library).
[0049] The manufacturing techniques used for making or altering an
implant component and/or guide tool can include any techniques
known in the art today and in the future. Such techniques include,
but are not limited to, additive as well as subtractive methods,
i.e., methods that add material, for example to a standard blank,
and methods that remove material, for example from a standard
blank. Various technologies and techniques appropriate for
manufacturing implants and guide tools can include, for example,
those summarized in Table 1.
TABLE-US-00001 TABLE 1 Exemplary technologies for manufacturing
implants and/or guide tools. Technique Brief description of
technique and related notes CNC CNC refers to computer numerically
controlled (CNC) machine tools, a computer-driven technique, e.g.,
computer-code instructions, in which machine tools are driven by
one or more computers. Embodiments of this method can interface
with CAD software to streamline the automated design and
manufacturing process. CAM CAM refers to computer-aided
manufacturing (CAM) and can be used to describe the use of software
programming tools to efficiently manage manufacturing and
production of products and prototypes. CAM can be used with CAD to
generate CNC code for manufacturing three-dimensional objects.
Casting, including Casting is a manufacturing technique that
employs a mold. casting using rapid Typically, a mold includes the
negative of the desired shape of prototyped casting a product. A
liquid material is poured into the mold and patterns allowed to
cure, for example, with time, cooling, and/or with the addition of
a solidifying agent. The resulting solid material or casting can be
worked subsequently, for example, by sanding or bonding to another
casting to generate a final product. Welding Welding is a
manufacturing technique in which two components are fused together
at one or more locations. In certain embodiments, the component
joining surfaces include metal or thermoplastic and heat is
administered as part of the fusion technique. Forging Forging is a
manufacturing technique in which a product or component, typically
a metal, is shaped, typically by heating and applying force. Rapid
prototyping Rapid prototyping refers generally to automated
construction of a prototype or product, typically using an additive
manufacturing technology, such as EBM, SLS, SLM, SLA, DMLS, 3DP,
FDM and other technologies EBM .RTM. EBM .RTM. refers to electron
beam melting (EBM .RTM.), which is a powder-based additive
manufacturing technology. Typically, successive layers of metal
powder are deposited and melted with an electron beam in a vacuum.
SLS SLS refers to selective laser sintering (SLS), which is a
powder- based additive manufacturing technology. Typically,
successive layers of a powder (e.g., polymer, metal, sand, or other
material) are deposited and melted with a scanning laser, for
example, a carbon dioxide laser. SLM SLM refers to selective laser
melting .TM. (SLM), which is a technology similar to SLS; however,
with SLM the powder material is fully melted to form a fully-dense
product. SLA or SL SLA or SL refers to stereolithography (SLA or
SL), which is a liquid-based additive manufacturing technology.
Typically, successive layers of a liquid resin are exposed to a
curing, for example, with UV laser light, to solidify each layer
and bond it to the layer below. This technology typically requires
the additional and removal of support structures when creating
particular geometries. DMLS DMLS refers to direct metal laser
sintering (DMLS), which is a powder-based additive manufacturing
technology. Typically, metal powder is deposited and melted locally
using a fiber optic laser. Complex and highly accurate geometries
can be produced with this technology. This technology supports net-
shaping, which means that the product generated from the technology
requires little or no subsequent surface finishing. LC LC refers to
LaserCusing .RTM.(LC), which is a powder-based additive
manufacturing technology. LC is similar to DMLS; however, with LC a
high-energy laser is used to completely melt the powder, thereby
creating a fully-dense product. 3DP 3DP refers to three-dimensional
printing (3DP), which is a high-speed additive manufacturing
technology that can deposit various types of materials in powder,
liquid, or granular form in a printer-like fashion. Deposited
layers can be cured layer by layer or, alternatively, for granular
deposition, an intervening adhesive step can be used to secure
layered granules together in bed of granules and the multiple
layers subsequently can be cured together, for example, with laser
or light curing. LENS LENS .RTM. refers to Laser Engineered Net
Shaping .TM. (LENS .RTM.), which is a powder-based additive
manufacturing technology. Typically, a metal powder is supplied to
the focus of the laser beam at a deposition head. The laser beam
melts the powder as it is applied, in raster fashion. The process
continues layer by and layer and requires no subsequent curing.
This technology supports net-shaping, which means that the product
generated from the technology requires little or no subsequent
surface finishing. FDM FDM refers to fused deposition modeling .TM.
(FDM) is an extrusion-based additive manufacturing technology.
Typically, beads of heated extruded polymers are deposited row by
row and layer by layer. The beads harden as the extruded polymer
cools.
[0050] Currently, implant components and/or guide tools of joint
repair systems often employ metal and/or polymeric materials. A
wide-variety of metals can be used in the practice of the
embodiments described herein, and can be selected based on any
criteria. For example, material selection can be based on
resiliency to impart a desired degree of rigidity. Non-limiting
examples of suitable metals include silver, gold, platinum,
palladium, iridium, copper, tin, lead, antimony, bismuth, zinc,
titanium, cobalt, stainless steel, nickel, iron alloys, cobalt
alloys, such as Elgiloy.RTM., a cobalt-chromium-nickel alloy, and
MP35N, a nickel-cobalt-chromiummolybdenum alloy, and Nitinol T.TM.,
a nickel-titanium alloy, aluminum, manganese, iron, tantalum,
crystal free metals, such as Liquidmetal.RTM. alloys (available
from LiquidMetal Technologies, www.liquidmetal.com), other metals
that can slowly form polyvalent metal ions, for example to inhibit
calcification of implanted substrates in contact with a patient's
bodily fluids or tissues, and combinations thereof.
[0051] A wide-variety of polymers can additionally or alternatively
be used in the practice of the embodiments described herein.
Suitable synthetic polymers include, without limitation, polyamides
(e.g., nylon), polyesters, polystyrenes, polyacrylates, vinyl
polymers (e.g., polyethylene, polytetrafluoroethylene,
polypropylene and polyvinyl chloride), polycarbonates,
polyurethanes, poly dimethyl siloxanes, cellulose acetates,
polymethyl methacrylates, polyether ether ketones, ethylene vinyl
acetates, polysulfones, nitrocelluloses, similar copolymers and
mixtures thereof. Bioresorbable synthetic polymers can also be used
such as dextran, hydroxyethyl starch, derivatives of gelatin,
polyvinylpyrrolidone, polyvinyl alcohol, poly[N-(2-hydroxypropyl)
methacrylamide], poly(hydroxy acids), poly(epsilon-caprolactone),
polylactic acid, polyglycolic acid, poly(dimethyl glycolic acid),
poly(hydroxy butyrate), and similar copolymers. Other appropriate
materials include, for example, the polyketone known as
polyetheretherketone (PEEK).
[0052] In various embodiments, the body and/or guide surfaces of
guide slots, spring-fit structures, and/or surgical guides may
comprise metals, plastics, ceramics or various combinations
thereof.
[0053] The various descriptions contained herein are merely
exemplary in nature and, thus, variations that do not depart from
the gist of the teachings are intended to be within the scope of
the teachings. Such variations are not to be regarded as a
departure from the spirit and scope of the teachings, and the
mixing and matching of various features, elements and/or functions
between various embodiments is expressly contemplated herein. One
of ordinary skill in the art would appreciate from this disclosure
that features, elements and/or functions of one embodiment may be
incorporated into another embodiment as appropriate, unless
described otherwise above. Many additional changes in the details,
materials, and arrangement of parts, herein described and
illustrated, can be made by those skilled in the art. Accordingly,
it will be understood that the following claims are not to be
limited to the embodiments disclosed herein, can include practices
otherwise than specifically described, and are to be interpreted as
broadly as allowed under the law.
* * * * *
References