U.S. patent application number 16/016328 was filed with the patent office on 2019-11-28 for staple and plate hard tissue fixation.
The applicant listed for this patent is Subluxation Safe Asset, LP. Invention is credited to Diana Rogers.
Application Number | 20190357951 16/016328 |
Document ID | / |
Family ID | 68615398 |
Filed Date | 2019-11-28 |
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United States Patent
Application |
20190357951 |
Kind Code |
A1 |
Rogers; Diana |
November 28, 2019 |
STAPLE AND PLATE HARD TISSUE FIXATION
Abstract
A hard tissue fixation staple-plate interlocking device can
include a recess in a staple body or a plate. The device can also
include a locking part of the other of the staple body or plate.
The device can be reconfigurable between an insertion configuration
and an interlocked configuration. In the insertion configuration,
the locking part can slide into the recess in a translation sliding
motion that is parallel to a sliding motion of the legs of the
staple, as the legs of the staple slide through the holes in the
plate. In the interlocked configuration, the locking part can be at
least partially in the recess, and recess surface portions can
engage part surface portions and inhibit movement of the staple and
plate out of the interlocked configuration. Also, multiple staples
and screws can be interlocked with the plate, with staples being at
non-parallel angles to each other.
Inventors: |
Rogers; Diana; (Southwest
Ranches, FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Subluxation Safe Asset, LP |
Southwest Ranches |
FL |
US |
|
|
Family ID: |
68615398 |
Appl. No.: |
16/016328 |
Filed: |
June 22, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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62675075 |
May 22, 2018 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/0645 20130101;
A61B 2017/564 20130101; A61B 2017/00867 20130101; A61B 17/8061
20130101; A61B 17/0642 20130101; A61B 17/809 20130101; A61B
2017/0641 20130101; A61B 17/86 20130101; A61B 2017/00526
20130101 |
International
Class: |
A61B 17/80 20060101
A61B017/80; A61B 17/064 20060101 A61B017/064; A61B 17/86 20060101
A61B017/86 |
Claims
1. A hard tissue fixation system comprising: a plate defining a
pair of holes formed therein; a staple comprising a body joining a
pair of legs of the staple; and a staple-plate interlocking device
comprising: a recess formed in one of the staple body or the plate,
with recess surface portions formed thereon, and with the recess
widening as it extends deeper into the recess; a locking part of
the other of the staple body or the plate, with the locking part
having part surface portions formed thereon, wherein the
staple-plate interlocking device is reconfigurable between: an
insertion configuration in which the locking part is configured to
slide into the recess in a translation sliding motion that is
parallel to a sliding motion of the legs of the staple, as the legs
of the staple slide through the holes in the plate; and an
interlocked configuration with the locking part at least partially
in the recess, in which the recess surface portions engage the part
surface portions and inhibit movement of the staple and plate out
of the interlocked configuration, with the legs of the staple
extending through the holes in the plate and being configured to
extend into hard tissue adjacent to the plate.
2. The hard tissue fixation system of claim 1, wherein the recess
is a groove in the plate and the locking part is the staple
body.
3. The hard tissue fixation system of claim 1, wherein one of the
locking part and the recess has a different curvature in the
insertion configuration than in the interlocked configuration.
4. The hard tissue fixation system of claim 3, wherein the one of
the locking part and the recess that has a different curvature is
formed of a shape memory alloy, and wherein an original shape of
the shape memory alloy is a shape in the interlocked
configuration.
5. The hard tissue fixation system of claim 1, wherein the recess
is a groove in the plate and the locking part is the staple body,
and wherein at least a portion of the staple body has a different
curvature in the insertion configuration than in the interlocked
configuration.
6. The hard tissue fixation system of claim 5, wherein a curvature
of the at least a portion of the staple body aligns with an opening
of the groove in the insertion configuration, and wherein the
curvature of the at least a portion of the staple body misaligns
with the opening of the groove in the interlocked
configuration.
7. The hard tissue fixation system of claim 1, wherein: in the
insertion configuration, the legs of the staple are substantially
parallel to each other; and in the interlocked configuration, the
legs of the staple angle inwardly toward each other as the legs
extend from the staple body and into the hard tissue.
8. The hard tissue fixation system of claim 7, wherein, in the
interlocked configuration, the plate is pinched between the legs of
the staple, at or adjacent to a base portion of each leg.
9. The hard tissue fixation system of claim 1, wherein the staple
spans at least three holes in the plate that are each configured to
receive a staple leg, wherein the at least three holes include the
pair of holes and one or more intermediate holes between the pair
of holes.
10. A hard tissue fixation system comprising: a plate defining: a
first pair of holes formed therein; and a second pair of holes
formed therein, wherein a line between centers of the first pair of
holes is at a non-parallel angle to a line between centers of the
second pair of holes; a first staple comprising a body joining a
pair of legs that are configured to extend through the first pair
of holes and are configured to extend into hard tissue; and a
second staple comprising a body joining a pair of legs that are
configured to extend through the second pair of holes and are
configured to extend into hard tissue.
11. The hard tissue fixation system of claim 10, wherein each hole
in the first pair of holes is configured to receive a screw.
12. The hard tissue fixation system of claim 10, wherein the plate
further defines an additional hole, and wherein the fixation system
further comprises a screw that is configured to extend through the
additional hole and into hard tissue.
13. The hard tissue fixation system of claim 10, wherein the first
staple comprises more than two legs, with each leg of the first
staple being configured to extend through a hole in the plate and
into hard tissue.
14. The hard tissue fixation system of claim 10, wherein the plate
defines a first groove extending between the first pair of holes
and a second groove extending between the second pair of holes,
wherein the body of the first staple is configured to have a
curvature that presses the body of the first staple against one or
more surface portions defining the first groove to lock the body of
the first staple to the plate in an interlocked configuration of
the first staple, and wherein the body of the second staple is
configured to have a curvature that presses the body of the second
staple against one or more surface portions defining the second
groove to lock the body of the second staple to the plate in an
interlocked configuration of the second staple.
15. The hard tissue fixation system of claim 14, wherein: the
interlocked configuration of the first staple comprises the pair of
legs of the first staple angling inwardly toward each other as the
pair of legs of the first staple extend away from the body of the
first staple, pinching the plate between the pair of legs of the
first staple; and the interlocked configuration of the second
staple comprises the pair of legs of the second staple angling
inwardly toward each other as the pair of legs of the second staple
extend away from the body of the second staple, pinching the plate
between the pair of legs of the second staple.
16. A method of hard tissue fixation, the method comprising:
positioning a plate adjacent to hard tissue, with the plate
defining a pair of holes formed therein; inserting a staple, with
the staple having a pair of legs and a body joining the pair of
legs, with the inserting of the staple comprising sliding the pair
of legs of the staple in an insertion direction through holes in
the plate and into the hard tissue, with a staple-plate
interlocking device being in an insertion configuration during the
inserting, and with a locking part of one of the staple body and
the plate and a recess of the other of the staple body and the
plate sliding together in a translation motion in a direction
parallel to the insertion direction; transitioning the staple-plate
interlocking device from the insertion configuration to an
interlocked configuration, with the interlocked configuration
comprising: the legs of the staple extending through the holes in
the plate and into the hard tissue adjacent to the plate; the
locking part of one of the staple body and the plate being at least
partially within the recess in the other of the staple body and the
plate; and surface portions of the recess engaging with surface
portions of the locking part, with the engaging of the surface
portions inhibiting movement of the staple and plate out of the
interlocked configuration.
17. The method of claim 16, wherein the recess is a groove in the
plate.
18. The method of claim 16, wherein one of the locking part and the
recess has a different curvature in the insertion configuration
than in the interlocked configuration.
19. The method of claim 18, wherein the one of the locking part and
the recess that has a different curvature is formed of a shape
memory alloy, wherein an original shape of the shape memory alloy
is a shape in the interlocked configuration, and wherein
transitioning the interlocking device to the interlocked
configuration comprises transitioning the shape memory alloy to the
original shape.
20. The method of claim 16, wherein the recess is a groove in the
plate, and wherein at least a portion of the staple body has a
different curvature in the insertion configuration than in the
interlocked configuration.
21. The method of claim 16, wherein the interlocked configuration
comprises at least five separate areas of engagement between the
staple and the plate, with each of the five separate areas of
engagement contributing to inhibiting movement of the staple and
the plate out of the interlocked configuration.
Description
RELATED APPLICATIONS
[0001] The present application is a non-provisional application
claiming the benefit of the filing date of U.S. Provisional
Application No. 62/675,075, filed May 22, 2018, which is
incorporated herein by reference. If any disclosures are
incorporated herein by reference and such incorporated disclosures
conflict in part or whole with the present disclosure, then to the
extent of conflict, and/or broader disclosure, and/or broader
definition of terms, the present disclosure controls. If such
incorporated disclosures conflict in part or whole with one
another, then to the extent of conflict, the later-dated disclosure
controls.
BACKGROUND
[0002] In surgical procedures it is often advantageous to fix a
plate to hard tissue such as bone. For example, this may be done in
fusing bones together or in adding structural stability to bones
that have been broken or otherwise damaged. Plates have been fixed
to adjacent bones by threading screws through the plates and into
the bones.
SUMMARY
[0003] It has been found that current techniques for fixing plates
to hard tissue can be improved by fixing plates to bones using
staples in addition to or instead of screws. Additionally, novel
configurations of staples and plates have been identified that can
produce advantageous results in fixing plates to hard tissue.
[0004] According to one aspect, a hard tissue fixation system
includes a plate defining a pair of holes formed therein, a staple
including a body joining a pair of legs of the staple, and a
staple-plate interlocking device, which can include features of the
staple and the plate. The staple-plate interlocking device can
include a recess formed in one of the staple body or the plate,
with recess surface portions formed thereon, and with the recess
widening as it extends deeper into the recess. The interlocking
device can also include a locking part of the other of the staple
body or the plate, with the locking part having part surface
portions formed thereon. The staple-plate interlocking device can
be reconfigurable between an insertion configuration and an
interlocked configuration. In the insertion configuration, the
locking part can be configured to slide into the recess in a
translation sliding motion that is parallel to a sliding motion of
the legs of the staple, as the legs of the staple slide through the
holes in the plate. In the interlocked configuration, the locking
part can be at least partially in the recess, and the recess
surface portions can engage the part surface portions and inhibit
movement of the staple and plate out of the interlocked
configuration, with the legs of the staple extending through the
holes in the plate and being configured to extend into hard tissue
adjacent to the plate.
[0005] According to another aspect, a hard tissue fixation system
can include a plate defining a first pair of holes formed therein
and a second pair of holes formed therein. A line between centers
of the first pair of holes can be at a non-parallel angle to a line
between centers of the second pair of holes. The first staple can
include a body joining a pair of legs that extend through the first
pair of holes and are configured to extend into hard tissue. The
second staple can include a body joining a pair of legs that extend
through the second pair of holes and are configured to extend into
hard tissue.
[0006] According to yet another aspect, a plate can be positioned
adjacent to hard tissue, with the plate defining a pair of holes
formed therein. A staple can be inserted, where the staple can have
a pair of legs and a body joining the pair of legs. The inserting
of the staple can include inserting the pair of legs of the staple
in an insertion direction through holes in the plate and into the
hard tissue. A staple-plate interlocking device can be in an
insertion configuration during the inserting. A locking part of one
of the staple body and the plate, and a recess of the other of the
staple body and the plate can slide together in a translation
motion in a direction parallel to the insertion direction. The
staple-plate interlocking device can be transitioned from the
insertion configuration to an interlocked configuration. The
interlocked configuration can include the legs of the staple
extending through the holes in the plate and into the hard tissue
adjacent to the plate. The interlocked configuration can also
include the locking part of one of the staple body and the plate
being at least partially within the recess in the other of the
staple body and the plate. Additionally, the interlocked
configuration can include surface portions of the recess engaging
with surface portions of the locking part, with the engaging of the
surface portions inhibiting movement of the staple and plate out of
the interlocked configuration.
[0007] This Summary is provided to introduce a selection of
concepts in a simplified form. The concepts are further described
below in the Detailed Description. This Summary is not intended to
identify key features or essential features of the claimed subject
matter, nor is it intended to be used to limit the scope of the
claimed subject matter. Similarly, the invention is not limited to
implementations that address the particular techniques, tools,
environments, disadvantages, or advantages discussed in the
Background, the Detailed Description, or the attached drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1 is a perspective view of a fixation system that is
fixed to hard tissue, with the fixation system in an assembled
interlocked configuration.
[0009] FIG. 2 is a top view of the fixation system and hard tissue
of FIG. 1. Note that directional terms such as top, front, side,
bottom, etc. are used herein with reference to the figures for
convenience in describing the system. The system may be used in
many different orientations, as is appropriate for using the
fixation system for securing a plate to hard tissue in different
circumstances.
[0010] FIG. 3 is a sectional view of the fixation system of FIG. 1
in the assembled interlocked configuration, taken along line 3-3 of
FIG. 2.
[0011] FIG. 4 is a sectional view of the fixation system of FIG. 1
in the assembled interlocked configuration, taken along line 4-4 of
FIG. 2.
[0012] FIG. 5 is a perspective view of a staple of the fixation
system of FIG. 1, but with the staple in an unactivated state that
can be used for an insertion configuration with a corresponding
plate. As used herein, an unactivated state of the staple refers to
the staple being in an initial shape that allows it to be inserted,
such as into a corresponding plate and/or hard tissue. An activated
state of the staple refers to the staple being in a shape that is
different from the shape in the initial unactivated state, so that
the staple engages hard tissue and/or engages a plate in an
interlocked configuration between the staple and plate. The
activation of the staple to change the staple from the unactivated
state to the activated state may be performed in one or more of
different ways, such as releasing tension on the staple and/or
changing temperature of a shape memory material staple, as
discussed below.
[0013] FIG. 6 is a front view of the staple of FIG. 5 in the
unactivated state.
[0014] FIG. 7 is a top view of the staple of FIG. 5 in the
unactivated state.
[0015] FIG. 8 is a perspective view of the staple of FIG. 5, but
with the staple in an activated state that can be used for engaging
hard tissue and may also be used for interlocking with a plate in
an interlocked configuration after insertion of the staple.
[0016] FIG. 9 is a front view of the staple of FIG. 8 in the
activated state.
[0017] FIG. 10 is a top view of the staple of FIG. 8 in the
activated state.
[0018] FIG. 11 is a perspective view of a plate of the fixation
system of FIG. 1.
[0019] FIG. 12 is a top view of the plate of FIG. 11.
[0020] FIG. 13 is an exploded perspective view of the fixation
system of FIG. 1, but with the system assembled in an insertion
configuration.
[0021] FIG. 14 is an assembled perspective view of the fixation
system of FIG. 13, assembled and still in the insertion
configuration (i.e., without being interlocked).
[0022] FIG. 15 is a top view of the assembled fixation system of
FIG. 14 in the insertion configuration.
[0023] FIG. 16 is a section view of the fixation system of FIG. 14
in the assembled insertion configuration, taken along line 16-16 of
FIG. 15.
[0024] FIG. 17 is a sectional view of the fixation system of FIG.
14 in the assembled insertion configuration, taken along line 17-17
of FIG. 15.
[0025] FIG. 18 is a perspective view of a four-prong staple in an
unactivated state.
[0026] FIG. 19 is a perspective view of the four-prong staple of
FIG. 18 in an activated state.
[0027] FIG. 20 is a perspective view of a five-prong staple in an
unactivated state.
[0028] FIG. 21 is a perspective view of the five-prong staple of
FIG. 20 in an activated state.
[0029] FIG. 22 is a top view of a plate that can be used in a
fixation system with staples and/or screws.
[0030] FIG. 23 is a top view of a fixation system using the plate
of FIG. 22, in an interlocked configuration with two two-pronged
staples, two screws, and one four-pronged staple.
[0031] The description and drawings may refer to the same or
similar features in different drawings with the same reference
numbers.
DETAILED DESCRIPTION
I. Overview of an Example Hard Tissue Fixation System
[0032] Referring to FIGS. 1-4, a hard tissue fixation system (100)
is illustrated in an interlocked configuration. The fixation system
(100) includes a plate (102) and a staple (104), with the staple
(104) fixing the plate to hard tissue (106). The hard tissue (106)
can be different shapes and sizes, and the plate (102) and staple
(104) may also be different shapes and sizes. As is discussed more
below, the staple (104) and the plate (102) can be interlocked with
each other in multiple different areas of engagement, produced by a
staple-plate interlocking device (108), which can include
complementary features of the plate (102) and the staple (104). The
interlocking device (108) can inhibit movement of the staple (104)
and plate (102) out of the interlocked configuration, which can
prevent the fixation system (100) from loosening over time and
ceasing to properly perform its fixation function. The fixation
system (100) can be reconfigured between an insertion
configuration, wherein the legs of the staple (104) can slide into
corresponding holes in the plate (102), and the interlocked
configuration illustrated in FIGS. 1-4. For example, the staple
(104) can be inserted into the plate (102) in the insertion
configuration, and one or both of the staple (104) and plate (102)
can change shape from an unactivated state to an activated state to
form the interlocked configuration, so that the staple (104) and
plate (102) interlock with each other. Also, as is discussed below
with reference to FIGS. 22-23, a plate may include more than two
staple-receiving holes, and those holes can be configured to
receive staple legs or screws, so that staples and screws can be
combined in different configurations to fix the plate to adjacent
hard tissue. Such arrangements can produce substantial benefits
that are not present in or predictable from prior systems and
methods for fixing plates to hard tissue. For example, the staple
(104) can compress hard tissue (106) to more securely fix a plate
(102) to the hard tissue (106), and the interlocking device (108)
can securely hold the staple (104) and plate (102) together, so
that the overall fixation system (100) can fix a plate (102) to
hard tissue in a secure manner, such as at four or more separate
interlocking areas of contact between the staple (104) and plate
(102).
[0033] The subject matter defined in the appended claims is not
necessarily limited to the benefits described herein. A particular
implementation of the invention may provide all, some, or none of
the benefits described herein. Although operations for the various
techniques are described herein in a particular, sequential order
for the sake of presentation, it should be understood that this
manner of description encompasses rearrangements in the order of
operations, unless a particular ordering is required. For example,
operations described sequentially may in some cases be rearranged
or performed concurrently.
II. Features of the Hard Tissue Fixation System
[0034] Referring to FIGS. 5-10, the staple (104) will be described
in more detail. The staple (104) can include a pair of legs (120)
that are joined by a body (122), which can act as a locking part.
Each leg can define barbs (124), which can engage hard tissue (106)
to help inhibit movement of the staple (104) out of the hard tissue
(106) (see FIG. 3). As can be seen in FIG. 4, the body (122) can
widen as it extends in an insertion direction (toward terminal ends
of the legs). For example, the body (122) can have a rounded
triangular cross section. Each leg (120) can also have a rounded
triangular cross section, with a surface on which the barbs (124)
are formed facing the opposite leg (120).
[0035] FIGS. 5-7 illustrate the staple (104) in the unactivated
state, which the staple (104) can be in for the insertion
configuration with a corresponding plate (102). In this unactivated
state, the staple (104) may be under tension, and is not in the
original high temperature shape of the staple (104) to which the
staple (104) tends to return in embodiments where the staple (104)
is made of shape memory alloy materials. In the unactivated state,
the legs (120) can be parallel to each other, extending away from
opposite ends of the body (122) in an insertion direction (130)
that is perpendicular to the longitudinal axis of the body (122) of
the staple (104) (see FIG. 5). The body (122) of the staple (104)
can extend between the base portions (123) of the legs (120)
without curving, as illustrated, or at least with curvature that is
less than in the activated state for the interlocked
configuration.
[0036] Referring to FIGS. 8-10, the staple (104) is illustrated in
an activated state. In this activated state, the legs (120) of the
staple (104) can angle inwardly toward each other as they extend
generally in the insertion direction (130) away from the body (122)
of the staple (104). Additionally, the body (122) of the staple
(104) can form a bow, curving in a plane (132) (see FIG. 6) that is
generally perpendicular to the insertion direction (130) and
parallel to the opposing faces of the plate (102) when the staple
(104) is inserted into the plate (102).
[0037] As discussed above, the staple (104) can be formed of a
shape memory material, for example a shape memory alloy, such as
nitinol. The staple (104) may be initially formed using
manufacturing techniques such as three-dimensional printing,
molding, and/or machining. The staple (104) may then be trained to
exhibit the shape in the unactivated state as a temporary shape,
and the shape in the activated state as an original shape to which
the staple (104) returns. More specifically, objects formed of such
shape memory materials can have an "original" shape to which the
object will return, such as when the object is heated above a
threshold temperature. Using known manufacturing techniques, which
can include thermomechanical processing, such objects can be
"trained" to return to the original shape when subject to a
specific threshold temperature. The threshold temperature may be a
range, but it can be adjusted through manufacturing techniques. For
example, the threshold temperature for the staple (104) to
transform from its unactivated state (FIGS. 5-7), in which it can
be delivered to a clinician for use, to its original shape in the
activated state (FIGS. 8-10) may be set somewhere between room
temperature and the temperature of a living body in which the
staple (104) will be implanted during a surgical procedure. For
example, the threshold temperature may be a temperature between
eighty-five and ninety-five degrees Fahrenheit. The threshold
temperature may be reached by allowing the body in which the staple
(104) is implanted to heat the staple (104). Also, the threshold
temperature of the staple (104) may be reached by actively applying
thermal heat to the staple (104) from another source.
[0038] Referring still to FIGS. 1-4 and to FIGS. 11-12, the plate
(102) will be discussed in more detail. The illustrated plate (102)
is generally rectangular, though many different shapes of plates
can be used in accordance with the features discussed herein. Also,
the plate (102) is illustrated as being generally flat, or planar,
but plates may be utilized that are curved in different shapes
appropriate for different applications, such as for being secured
to different bones and in different locations.
[0039] The plate (102) illustrated in FIGS. 1-4 and FIGS. 11-12
defines a pair of holes (140) passing through the plate (102). The
holes (140) can be sized and positioned to receive the legs (120)
of the staple (104), with the holes (140) being spaced to match the
spacing between the base portions (123) of the legs (120) of the
staple (104). Also, the holes (140) can include counterbores or
countersinks facing in a top direction (opposite the insertion
direction (130)), for receiving matching heads of screws. The holes
(140) may also be configured so that threads of screws can engage
the material surrounding the holes (140) to "lock" the screws in
place relative to the plate (102). Additionally, the plate (102)
can define a recess that can be in the form of a groove (142) that
extends in the insertion direction (130) into the plate (102) from
a second face of the plate (102) (which is opposite the first face
of the plate). As the groove (142) extends deeper in the insertion
direction (130), the groove (142) can widen. Thus, the groove (142)
can have a generally trapezoidal cross-sectional shape (with its
opening at the second face of the plate being narrower than its
floor, and walls angling from the opening to the floor) that can
complement the generally triangular cross-sectional shape of the
staple body (122).
[0040] The plate (102) can be made of sufficiently rigid and
biocompatible materials that are suitable for implanting in living
bodies, such as titanium alloys or stainless-steel alloys. The
plate can be formed with one or more of various manufacturing
techniques, such as three-dimensional printing, molding, and/or
machining
[0041] Accordingly, when the fixation system (100) is in the
insertion configuration, illustrated in FIGS. 13-17, the legs (120)
of the staple (104) can slide through the holes (140) in the plate
(102) in the insertion direction (130). With that same translation
sliding motion, the body (122) of the staple (104) can slide in the
insertion direction (130) into the groove (142) in the plate. As is
illustrated, the body (122) of the staple (104) aligns with an
opening of the groove (142), and the body (122) has substantially
the same curvature as the groove (142) (being straight in the
illustrated embodiment).
[0042] In contrast, in the interlocked configuration illustrated in
FIGS. 1-4, surface portions of the plate (102) and the surface
portions of the staple (104) can engage each other at multiple
separate engagement areas. Specifically, the engagement areas can
include three body engagement areas (160) (see FIGS. 1-2) where
surface portions of the body (122) of the staple (104) engage
surface portions of the groove (142) in the plate (102), with one
body engagement area (160) at each end of the body (122) on one
side of the body (122) and another body engagement area (160) in
the middle of the body (122) on an opposite side of the body (122).
These body engagement areas (160) can be formed by the curvature of
the body (122) along the plane (132) in the activated state of the
staple (104) for the interlocked configuration, which curvature is
different from the straight curvature of the groove (142),
resulting in the body (122) being misaligned with the groove (142).
The engagement areas can also include pinching engagement areas
(162) near the inner base portion (123) of each leg (120), where
the leg (120) is bent inwardly at the base portion (123) of the leg
(120) in the activated state of the staple (104) for the
interlocked configuration to pinch the plate (102) between the legs
(120) (see FIG. 3). Accordingly, the staple (104) and plate (102)
can interlock to engage each other in five engagement areas (three
body engagement areas (160) and two pinching engagement areas
(162)).
[0043] The interlocking device (108) can include the surface
portions of the plate (102) and the surface portions of the staple
(104) that form the body engagement areas (160) and the pinching
engagement areas (162). The interlocking device (108) can further
include the body (122) of the staple, and at least the base
portions (123) of the legs (120) of the staple (104). The
interlocking device (108) can further include the material of the
plate (102) that defines the groove (142), including the material
that engages the engaging surface portions of the body (122) of the
staple (104) and the material that is pinched between the surface
portions of the legs (120) of the staple (104) (with the pinching
also involving surface portions of the body (122) of the staple
(104)).
[0044] The hard tissue fixation system may include different
configurations of the staple and the plate, as compared to the
specific configurations illustrated in the attached figures for the
hard tissue fixation system (100). As one example, the interlocking
recess and locking part may be different from the groove in the
plate acting as the recess to receive the staple body acting as the
locking part in the discussion above, so long as a recess is in one
of the staple body or the plate, and the locking part is in the
other of the staple body or the plate. For example, the staple and
plate may be reconfigured so that the staple defines a recess into
which a protruding part of the plate fits. In such a configuration,
the staple and/or the plate may change shape between an insertion
configuration and an interlocked configuration. For example, the
plate may define a rail that fits into a recess (such as a groove)
formed in the body of the staple. The curvature of the rail and the
recess may match each other in the insertion configuration, so that
the rail can fit into the recess as the staple is inserted through
holes in the plate. The shape of the plate and/or staple can change
in the interlocked configuration (e.g., using shape memory
material) so that the rail engages the material forming the recess.
Also, a shape-changing part such as the body (122) may have less
curvature in the interlocked configuration than in the insertion
configuration, such as where the mating part that does not change
shape has more curvature (for example, a curved staple body can
match the curvature of a curved groove in the plate in the
insertion configuration but can reduce its curvature to interlock
with the material defining the curved groove in the interlocked
configuration).
III. Example of Use of a Hard Tissue Fixation System
[0045] Use of the hard tissue fixation system (100) will now be
discussed. Referring to FIG. 13, a surgical procedure can include
drilling pilot holes (170) in the hard tissue (106) that are spaced
and sized to receive the legs (120) of the staple (104) (for
embodiment with screws as discussed below, holes for screws may
also be drilled). The plate (102) can be positioned with the holes
(140) in the plate aligning with the pilot holes (170), with a
first face of the plate being adjacent to the hard tissue (106),
such as abutting the hard tissue (106). The staple (104) can be
held with a staple insertion device (not shown), such as staple
insertion devices that have been used previously to insert staples
in hard tissue during surgical procedures. Using the staple
insertion device, a clinician can slide the staple (104) in the
insertion direction (130) toward the plate (102), to slide the legs
(120) of the staple through the holes (140) in the plate and into
the pilot holes (170) in the hard tissue (106). This translation
sliding motion in the insertion direction (130) can continue until
the body (122) of the staple (104) is seated in the groove (142),
and the clinician can actuate the staple insertion device to
release the staple (104). If the staple (104) is not sufficiently
inserted after it is released from the insertion device, a
clinician may use a tamp tool (or hammer) to tamp the staple (104)
further in the insertion direction (130) relative to the plate
(102), so that the staple is in the position illustrated in FIGS.
14-17. The staple (104) can activated, such as by heating the
staple (104) to its threshold shape memory temperature. For
example, this may be done by applying active heat to the staple
(104), applying electrical current to the staple (104) and/or
allowing the body into which the staple (104) is implanted to heat
the staple (104). This can result in the staple (104) transitioning
from its unactivated state to its original interlocked shape in its
activated state, resulting in the interlocked configuration
illustrated in FIGS. 1-4 and discussed above.
[0046] In addition to this transition to the interlocked
configuration being operable to interlock the staple (104) and
plate (102) together (including the compressing of the plate (102)
between the legs (120) of the staple (104)), the movement of the
legs (120) of the staple (104) toward each other can compress the
hard tissue (106) between the legs (120). For example, this is
illustrated in FIG. 3, showing the legs (120) having moved from the
pilot holes (170) and into the hard tissue (106) between the pilot
holes (170). This compression can help to inhibit movement of the
staple (104) out of the hard tissue (106), thereby providing a more
solid fixation of the plate (102) to the hard tissue (106).
IV. Examples of Staples with Additional Legs
[0047] Referring now to FIGS. 18-19, another embodiment of a staple
(200) will be discussed. The staple (200) can be a four-pronged
staple that has four legs (202). The legs (202) can be joined by a
body (204) that can include a pair of crossing beams (206) that
each extends between a pair of the legs (202). The beams (206) can
be perpendicular to each other, so that the staple (200) includes
two two-pronged staple structures that each includes one pair of
legs (202) joined by a beam (206). The two beams (206) can be
joined at their midpoints to form the overall staple (200). FIG. 18
illustrates an unactivated state, which can be used for an
insertion configuration with a plate, for the staple (200), where
the legs (202) are perpendicular to each other, with the legs
extending in an insertion direction that is substantially
perpendicular to a plane that includes both of the beams (206).
[0048] The staple (200) can transform to the activated state
illustrated in FIG. 19, where the legs (202) angle inwardly toward
each other as they extend in the insertion direction from the body
(204). For example, with each leg pair that is joined by a beam
(206), the legs (202) can angle inwardly toward each other as they
extend in the insertion direction from the body (204). The staple
(200) may be integrally formed from a suitable material, such as
the shape memory materials discussed above. As illustrated, the
body (204) of the staple (200) does not change shape between the
unactivated state and the activated state. The staple (200) may be
interlocked with a corresponding plate similar to the plate (102)
above except with four holes for the legs (202), using the pinching
engagement similar to the pinching engagement of the interlocked
configuration in the fixation system (100) discussed above. This
can provide at least four areas of interlocking engagement, with
one for each of the four legs (202), pinching the plate between
opposing pairs of legs. The beams (206) of the staple (200) may
also bend in the activated state for the interlocked configuration,
similarly to how the body (122) of the staple (104) bends to
produce additional interlocking engagement areas in the interlocked
configuration of the fixation system (100).
[0049] FIG. 20 illustrated a five-pronged staple (300) with four
legs (302) and a body (304) that includes crossing beams (306),
like the staple (200) of FIG. 2. The staple (300) also includes a
pin (308) that extends in an insertion direction (parallel to the
legs (302) in the unactivated state that can be used for an
insertion configuration) from a central area of the body (304)
where the crossing beams (306) are joined. The pin (308) can be
considered a fifth leg, or fifth prong, of the staple (300). In the
unactivated state illustrated in FIG. 20, the legs (302) and the
pin (308) can be inserted through holes in a corresponding plate
and into hard tissue. The staple (300) can transition to an
activated state illustrated in FIG. 21, which can be used for an
interlocked configuration, wherein the legs angle inwardly in the
same manner as the legs (202) of the staple (200). As with the
staple (200), the body (304) of the staple (300) could also bend to
provide additional interlocking engagement areas, like the staple
(104) discussed above. Also, each of the staples discussed herein,
may be advantageously secured in hard tissue without a
corresponding plate.
V. Examples with Plates Having Additional Holes for Receiving
Staples and/or Screws
[0050] Other configurations of staples and plates may also be used
with the novel features discussed herein. For example, FIG. 22
illustrates a plate (400) that can define 18 holes (410) like the
holes (140) of the plate (102) discussed above, arranged in a
three-by-six rectangular pattern. Grooves (412) can extend parallel
and perpendicular to each other between the holes (410). The
grooves (412) can be like the grooves (142) discussed above.
Staples can be inserted in and interlock with the plate (400) in
insertion configurations in ways like those discussed above and may
be interlocked with the plate (102) in ways like those discussed
above. For example, staples may be inserted in pairs of holes with
lines (420) between centers of the holes being at non-parallel
angles, such as being perpendicular, or with lines between them
being parallel to each other. Accordingly, multiple two-pronged
staples may be parallel to each other and/or perpendicular to each
other, and the plate (400) may also receive staples having more
than two prongs, as well as screws. The plate (400) may also
receive two-pronged staples that span more than two holes.
[0051] Referring now to FIG. 23, a top view of a fixation system
(500) is illustrated in an interlocked configuration. The fixation
system (500) in this example includes the plate (400). The fixation
system (500) also includes the four-pronged staple (200) discussed
above with reference to FIGS. 18-19 interlocked with the plate
(400), with opposite pairs of legs spanning three holes in the
plate (400). The five-pronged staple (300) could be inserted in and
interlocked with the plate (400) in a similar manner Additionally,
the fixation system (500) includes three two-pronged staples (104)
like the staple (104) discussed above in the fixation system (100).
The two-pronged staples (104) are interlocked with the plate (400)
in the same manner that the staple (104) interlocked with the plate
(102) in the fixation system (100) discussed above. In the example
of FIG. 23, two of the two-pronged staples (104) are parallel to
each other and a third two-pronged staple (104) is at a
non-parallel angle to the other two two-pronged staples (104).
Specifically, in this embodiment, the third two-pronged staple
(104) is perpendicular to the other two two-pronged staples (104).
Also, a two-pronged staple (512) can be the same as the staple
(104) discussed above, but the two-pronged staple (512) can be
configured so that it can span three or more holes in the plate
(400). Thus, the legs of the staple (512) can extend into a pair of
holes, and the plate can include one or more intermediate holes
between that pair of holes, without legs of the staple (512)
extending into those intermediate holes (or with legs of the staple
extending into those intermediate holes if the staple includes more
than two legs that are in line with each other). However, the
intermediate holes can be configured to receive staple legs and/or
screws (510), so that staple legs and/or screws can be inserted in
such holes in other fastener arrangements.
[0052] The fixation system (500) also includes two screws (510),
with each screw extending through one of the holes (410) and into
the underlying hard tissue to which the plate (400) is fixed by the
screws (510), the two-pronged staples (104) and the four-pronged
staple (200). Other different configurations and combinations of
plates, staples, and screws may be used in different circumstances,
such as where different configurations of one or more bones and/or
other soft tissue are being secured to a plate. The different types
of fasteners (104, 200, 512, etc.) and the plate (400) that is
configured to receive and interlock with these different fasteners
in different arrangements can allow a clinician to uniquely
configure a fixation system (500) in different ways to fit the
needs of different procedures.
VI. Discussion of Hard Tissue Fixation Aspects and Features
[0053] Multiple aspects of the features discussed herein will now
be described. The features discussed can be used in any combination
with each other that is not foreclosed by the discussion
herein.
[0054] According to one aspect, a hard tissue fixation system
includes a plate defining a pair of holes formed therein, a staple
including a body joining a pair of legs of the staple, and a
staple-plate interlocking device. The staple-plate interlocking
device can include a recess formed in one of the staple body or the
plate, with recess surface portions formed thereon, and with the
recess widening as it extends deeper into the recess. The
interlocking device can also include a locking part of the other of
the staple body or the plate, with the locking part having part
surface portions formed thereon. The staple-plate interlocking
device can be reconfigurable between an insertion configuration and
an interlocked configuration. In the insertion configuration, the
locking part can be configured to slide into the recess in a
translation sliding motion that is parallel to a sliding motion of
the legs of the staple, as the legs of the staple slide through the
holes in the plate. In the interlocked configuration, the locking
part can be at least partially in the recess, and the recess
surface portions can engage the part surface portions and inhibit
movement of the staple and plate out of the interlocked
configuration, with the legs of the staple extending through the
holes in the plate and being configured to extend into hard tissue
adjacent to the plate.
[0055] The recess can be a groove in the plate, and the locking
part can be the staple body. One of the locking part and the recess
can have a different curvature in the insertion configuration than
in the interlocked configuration. For example, the one of the
locking part and the recess that has a different curvature in the
different configurations can be formed of a shape memory alloy, and
an original shape of the shape memory alloy can be a shape in the
interlocked configuration.
[0056] As an example, where the recess is a groove in the plate and
the locking part is the staple body, at least a portion of the
staple body can have a different curvature in the insertion
configuration than in the interlocked configuration. In this
situation, a curvature of the at least a portion of the staple body
can align with an opening of the groove in the insertion
configuration, and the curvature of the at least a portion of the
staple body can misalign with the opening of the groove in the
interlocked configuration.
[0057] In the insertion configuration, the legs of the staple can
be substantially parallel to each other, such as within five
degrees of being parallel. In the interlocked configuration, the
legs of the staple can angle inwardly toward each other as the legs
extend in an insertion direction from the staple body and into the
hard tissue. In the interlocked configuration, the plate can be
pinched between the legs of the staple, at or adjacent to a base
portion of each leg.
[0058] According to another aspect, a hard tissue fixation system
can include a plate defining a first pair of holes formed therein
and a second pair of holes formed therein. A line between centers
of the first pair of holes can be at a non-parallel angle to a line
between centers of the second pair of holes. The first staple can
include a body joining a pair of legs that extend through the first
pair of holes and are configured to extend into hard tissue. The
second staple can include a body joining a pair of legs that extend
through the second pair of holes and are configured to extend into
hard tissue. Each hole in the first pair of holes can be configured
to receive a screw. Also, the plate can further define an
additional hole, and the fixation system can further include a
screw that is configured to extend through the additional hole and
into hard tissue. The first staple can include more than two legs,
with each leg of the staple being configured to extend through a
hole in the plate and into hard tissue.
[0059] The plate can define a first groove extending between the
first pair of holes and a second groove extending between the
second pair of holes. The body of the first staple can be
configured to have a curvature that presses the body of the first
staple against one or more surface portions defining the first
groove to lock the body of the first staple to the plate in an
interlocked configuration of the first staple. The body of the
second staple can be configured to have a curvature that presses
the body of the second staple against one or more surface portions
defining the second groove to lock the body of the second staple to
the plate in an interlocked configuration of the second staple.
Also, the interlocked configuration of each staple can include the
pair of legs of the staple, angling inwardly toward each other as
the pair of legs of the staple extend in an insertion direction
away from the body of the staple, pinching the plate between the
pair of legs of the staple.
[0060] According to yet another aspect, a plate can be positioned
adjacent to hard tissue, with the plate defining a pair of holes
formed therein. A staple can be inserted, where the staple can have
a pair of legs and a body joining the pair of legs. The inserting
of the staple can include the pair of legs of the staple in an
insertion direction through holes in the plate and into the hard
tissue (which may have been drilled with pilot holes prior to
insertion of the staple). A staple-plate interlocking device can be
in an insertion configuration during the inserting. A locking part
of one of the staple body and the plate and a recess of the other
of the staple body and the plate can slide together in a
translation motion in a direction parallel to the insertion
direction. The staple-plate interlocking device can be transitioned
from the insertion configuration to an interlocked configuration.
The interlocked configuration can include the legs of the staple
extending through the holes in the plate and into the hard tissue
adjacent to the plate. The interlocked configuration can also
include the locking part of one of the staple body and the plate
being at least partially within the recess in the other of the
staple body and the plate. Additionally, the interlocked
configuration can include surface portions of the recess engaging
with surface portions of the locking part, with the engaging of the
surface portions inhibiting movement of the staple and plate out of
the interlocked configuration.
[0061] The recess can be a groove in the plate. Also, one of the
locking part and the recess can have a different curvature in the
insertion configuration than in the interlocked configuration. The
one of the locking part and the recess that has a different
curvature can be formed of a shape memory alloy. An original shape
of the shape memory alloy can be a shape in the interlocked
configuration and transitioning the interlocking device to the
interlocked configuration can include transitioning the shape
memory alloy to the original shape. The recess can be a groove in
the plate, and at least a portion of the staple body can have a
different curvature in the insertion configuration than in the
interlocked configuration. Also, in the interlocked configuration,
the plate can be pinched between the legs of the staple, adjacent
to a base portion of each leg. The interlocked configuration can
include at least five separate areas of engagement between the
staple and the plate, with each of the five separate areas of
engagement contributing to inhibiting movement of the staple and
the plate out of the interlocked configuration.
[0062] While the invention has been particularly shown and
described with reference to preferred embodiments thereof, it will
be understood by those skilled in the art that various changes in
form and details may be made therein without departing from the
spirit and scope of the invention.
* * * * *