U.S. patent application number 16/100619 was filed with the patent office on 2018-12-06 for bone fixation implants.
The applicant listed for this patent is Jeko Metodiev Madjarov. Invention is credited to Jeko Metodiev Madjarov, Sophia Jekova Madjarova, Svetozar Madzharov.
Application Number | 20180344367 16/100619 |
Document ID | / |
Family ID | 53881115 |
Filed Date | 2018-12-06 |
United States Patent
Application |
20180344367 |
Kind Code |
A1 |
Madjarov; Jeko Metodiev ; et
al. |
December 6, 2018 |
Bone Fixation Implants
Abstract
A plating system is described that uses various configurations
of bone fixation implants that are configured to be attached to one
or more portions of bone. The bone fixation implant may include at
least one structural portion (e.g., a wire, plate, mesh, etc.) that
includes metal and a polymer body at least partially surrounding
the at least one structural portion. The polymer body may define an
engaging surface that is configured to engage an attachment member
that is applied to the bone fixation implant to fix the bone
fixation implant to the bone, such that direct contact between the
metal of the structural portion and the attachment member is
prevented. Overlying muscle and tissue may be secured to the bone
fixation implant to encourage incorporation of the tissue structure
into the implant and promote stabilization and healing.
Inventors: |
Madjarov; Jeko Metodiev;
(Charlotte, NC) ; Madjarova; Sophia Jekova;
(Charlotte, NC) ; Madzharov; Svetozar; (Charlotte,
NC) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Madjarov; Jeko Metodiev |
Charlotte |
NC |
US |
|
|
Family ID: |
53881115 |
Appl. No.: |
16/100619 |
Filed: |
August 10, 2018 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
14626437 |
Feb 19, 2015 |
10070904 |
|
|
16100619 |
|
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2002/30235
20130101; A61B 17/80 20130101; A61F 2/44 20130101; A61F 2002/30565
20130101; A61F 2002/30556 20130101; A61B 17/8076 20130101; A61B
17/842 20130101; A61F 2002/30092 20130101; A61F 2002/30601
20130101; A61B 2017/564 20130101; A61B 17/8071 20130101; A61F
2002/3055 20130101; A61B 17/823 20130101 |
International
Class: |
A61B 17/80 20060101
A61B017/80; A61F 2/44 20060101 A61F002/44; A61B 17/84 20060101
A61B017/84 |
Claims
1. A bone fixation implant configured to be attached to one or more
portions of bone of a chest wall, the bone fixation implant having
a bone-engaging surface and a muscle or soft tissue-engaging
surface opposite the bone-engaging surface, wherein the bone
fixation implant defines a plurality of openings arranged across an
overall length and an overall width of the bone fixation implant
and extending through the bone-engaging surface and the muscle or
soft tissue engaging surface, wherein each opening is configured to
receive an attachment member for securing the bone fixation implant
to an underlying bone structure of the chest wall such that the
bone-engaging surface of the bone fixation implant engages the
underlying bone structure of the chest wall, and wherein the bone
fixation implant is configured to be secured to an overlying muscle
or soft tissue structure such that the muscle or soft
tissue-engaging surface of the bone fixation implant engages the
overlying muscle or soft tissue structure, thereby encouraging
incorporation of the muscle or soft tissue structure into the bone
fixation implant to promote stabilization of the underlying bone
structure of the chest wall during healing.
2. The bone fixation implant of claim 1, wherein the muscle or soft
tissue-engaging surface comprises a plurality of enclosed channels
extending substantially parallel to the bone fixation implant,
wherein each enclosed channel defines a first open end and a second
open end, and wherein each enclosed channel is configured to
receive a suturing needle therethrough via the first and second
open ends, such that the overlying muscle or soft tissue structure
is securable to the bone fixation implant using sutures extending
from the tissue structure through at least one of the enclosed
channels.
3. The bone fixation implant of claim 2, wherein the enclosed
channels are arranged at different angles with respect to one
another.
4. The bone fixation implant of claim 2 further comprising: at
least one structural portion comprising metal; and a polymer body
at least partially surrounding the at least one structural portion,
wherein the polymer body defines an overall shape of the bone
fixation implant comprising the overall width, the overall length,
and an overall thickness, wherein the polymer body defines the
openings, such that direct contact between the metal of the
structural portion and the attachment member is prevented, and
wherein the polymer body defines the bone-engaging surface, the
muscle or soft tissue-engaging surface, and the enclosed channels
such that direct contact between the metal of the structural
portion and any of the bone structure of the chest wall, the muscle
or soft tissue-structure, or the sutures is prevented.
5. The bone fixation implant of claim 1, wherein the bone fixation
implant comprises polyether ether ketone (PEEK).
6. The bone fixation implant of claim 1 further comprising: at
least one structural portion comprising metal; and a polymer body
at least partially surrounding the at least one structural portion,
wherein the polymer body defines an overall shape of the bone
fixation implant comprising the overall width, the overall length,
and an overall thickness, wherein the polymer body defines the
openings, such that direct contact between the metal of the
structural portion and the attachment member is prevented, and
wherein the polymer body defines the bone-engaging surface and the
muscle or soft tissue engaging surface such that direct contact
between the metal of the structural portion and any of the bone
structure of the chest wall or the muscle or soft tissue-structure
is prevented.
7. The bone fixation implant of claim 6, wherein the polymer body
comprises polyether ether ketone (PEEK).
8. The bone fixation implant of claim 6, wherein the structural
portion comprises at least one of titanium, aluminum, stainless
steel, or Nitinol.
9. The bone fixation implant of claim 6, wherein the structural
portion comprises at least one of a wire, a plate, or a mesh.
10. The bone fixation implant of claim 1, wherein at least one of
the bone-engaging surface or the muscle or soft tissue-engaging
surface defines a texture configured to enhance engagement of the
bone fixation implant with the underlying bone structure of the
chest wall or the overlying muscle or soft tissue structure,
respectively.
11. The bone fixation implant of claim 1 further comprising a
plurality of eyelets extending outwardly from the muscle or soft
tissue-engaging surface, wherein each eyelet is configured to
receive a suturing needle therethrough, such that the overlying
muscle or soft tissue structure is securable to the bone fixation
implant using sutures extending from the tissue structure through
at least one of the eyelets.
12. The bone fixation implant of claim 1, wherein an overall
thickness of the bone fixation implant at a rim of each opening is
greater than the overall thickness in a region between adjacent
openings.
13. The bone fixation implant of claim 12, wherein the region
between adjacent openings is configured to receive a suturing
needle therethrough, such that the overlying muscle or soft tissue
structure is securable to the bone fixation implant using sutures
extending from the muscle or soft tissue structure through the
region.
14-18. (canceled)
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application No. 61/942,671 entitled "Bone Fixation Implants," filed
Feb. 21, 2014, the contents of which are incorporated herein in
their entirety.
FIELD OF THE INVENTION
[0002] The present invention relates generally to bone fixation
implants and methods for supporting and promoting healing of
fractured or broken bone, such as ribs, the sternum, facial bones,
and spinal bones, among others.
BACKGROUND
[0003] Bone fixation implants are used in a variety of medical
situations to support broken bones and promote healing. For
example, bone fixation implants may be used to replace missing
joints, bones, or portions of bone or to support a damaged bone. In
particular, one or more bone fixation implants, which may include
or be used in conjunction with pins, rods, screws, wires, and/or
plates, may be attached to a bone in the area of the fracture to
anchor the bone and/or hold portions of the damaged bone together
while it heals.
[0004] For example, a person who experiences chest trauma due to an
accident (e.g., a vehicle collision) may have rib fractures that
require the use of bone fixation implants. Implants may also be
used to promote healing after surgical procedures, such as a
thoracotomy or sternotomy. During a thoracotomy, for example, ribs
may be broken by a surgeon to provide access to organs such as the
heart and lungs. In a sternotomy, a longitudinal incision may be
made along a midline of a patient's sternum, and the two resulting
portions of the sternum may be forced apart to allow the surgeon to
gain access to the patient's thoracic cavity (e.g., during open
heart surgery). A surgeon may use bone fixation implants following
such procedures to repair the patient's chest cavity.
[0005] In still other cases, bone implants may be used to promote
the healing of other bones, such as bones in the face or spine. For
example, bone fixation implants may be used during facial plastic
surgery and reconstructive surgery to support the healing of bones
in the proper configuration. Implants may also be used in
neurosurgery of the spine to hold spinal bone portions together
during healing.
[0006] Accordingly, there is a need for bone fixation implants and
methods for supporting and promoting healing of fractured or broken
bone that are safe, reproducible, simple to administer, and cause
the least amount of pain to the patient.
BRIEF SUMMARY OF EXAMPLE EMBODIMENTS
[0007] Embodiments of the present invention, therefore, provide
bone fixation implants that can be secured to underlying bone and,
at the same time, can be attached to overlying tissue structure to
encourage the incorporation of muscle and/or soft tissue into the
bone fixation implant and promote stabilization of the bone
structure and facilitate healing.
[0008] In one embodiment, a bone fixation implant is provided that
is configured to be attached to one or more portions of bone. The
bone fixation implant may have a bone-engaging surface and a
tissue-engaging surface opposite the bone-engaging surface. The
bone fixation implant may define a plurality of openings arranged
across an overall length and an overall width of the bone fixation
implant, and the openings may extend through the bone-engaging
surface and the tissue-engaging surface. Each opening may be
configured to receive an attachment member for securing the bone
fixation implant to an underlying bone structure such that the
bone-engaging surface of the bone fixation implant engages the
underlying bone structure. Furthermore, the bone fixation implant
may be configured to be secured to an overlying tissue structure
such that the tissue-engaging surface of the bone fixation implant
engages the overlying tissue structure, thereby encouraging
incorporation of the tissue structure into the bone fixation
implant to promote stabilization of the underlying bone structure
during healing.
[0009] In some cases, the tissue-engaging surface may comprise a
plurality of enclosed channels extending substantially parallel to
the bone fixation implant, and each enclosed channel may define a
first open end and a second open end. Each enclosed channel may be
configured to receive a suturing needle therethrough via the first
and second open ends, such that the overlying tissue structure is
securable to the bone fixation implant using sutures extending from
the tissue structure through at least one of the enclosed channels.
The enclosed channels may, in some cases, be arranged at different
angles with respect to one another.
[0010] In some embodiments, the bone fixation implant may comprise
at least one structural portion comprising metal and a polymer body
at least partially surrounding the at least one structural portion.
The polymer body may define an overall shape of the bone fixation
implant comprising the overall width, the overall length, and an
overall thickness. The polymer body may define the openings, such
that direct contact between the metal of the structural portion and
the attachment member is prevented. In some cases, the polymer body
may define the bone-engaging surface, the tissue-engaging surface,
and the enclosed channels such that direct contact between the
metal of the structural portion and any of the bone structure, the
tissue-structure, or the sutures is prevented.
[0011] In some embodiments, the bone fixation implant may comprise
polyether ether ketone (PEEK). For example, in some cases, the
polymer body may comprise polyether ether ketone (PEEK), and the
structural portion may comprise at least one of titanium, aluminum,
stainless steel, or Nitinol. Moreover, in some embodiments, the
structural portion may comprise at least one of a wire, a plate, or
a mesh.
[0012] In some cases, the bone fixation implant may further
comprise a plurality of eyelets extending outwardly from the
tissue-engaging surface, wherein each eyelet is configured to
receive a suturing needle therethrough, such that the overlying
tissue structure is securable to the bone fixation implant using
sutures extending from the tissue structure through at least one of
the eyelets. In still other cases, the bone fixation implant may be
configured such that an overall thickness of the bone fixation
implant at a rim of each opening is greater than the overall
thickness in a region between adjacent openings. In this way, the
region between adjacent openings may be configured to receive a
suturing needle therethrough, such that the overlying tissue
structure is securable to the bone fixation implant using sutures
extending from the tissue structure through one or more of the
regions.
[0013] To promote engagement of the bone-engaging surface and the
tissue-engaging surface to the underlying bone structure and the
overlying tissue structure, respectively, at least one of the
bone-engaging surface or the tissue-engaging surface may define a
texture that is configured to enhance engagement of the bone
fixation implant with the underlying bone structure and/or the
overlying tissue structure, respectively.
[0014] Embodiments of a method of fixating bone are also provided
herein. In one embodiment, the method may include applying a bone
fixation implant to at least one portion of bone, wherein the bone
fixation implant has a bone-engaging surface and a tissue-engaging
surface opposite the bone-engaging surface. The bone fixation
implant may define a plurality of openings arranged across an
overall length and an overall width of the bone fixation implant
and extending through the bone-engaging surface and the
tissue-engaging surface. An attachment member may be inserted into
a respective one of the openings to secure the bone fixation
implant to an underlying bone structure such that the bone-engaging
surface of the bone fixation implant engages the underlying bone
structure. In addition, an overlying tissue structure may be
sutured to the bone fixation implant such that the tissue-engaging
surface of the bone fixation implant engages the overlying tissue
structure, thereby encouraging incorporation of the tissue
structure into the bone fixation implant to promote stabilization
of the underlying bone structure during healing.
[0015] In some cases, an overall shape of the bone fixation implant
may be modified by cutting off a portion of the bone fixation
implant to correspond to a shape of an area of the underlying bone
structure to be treated. Additionally or alternatively, the
tissue-engaging surface may comprise one of (a) a plurality of
enclosed channels extending substantially parallel to the bone
fixation implant or (b) a plurality of eyelets extending outwardly
from the tissue-engaging surface, and suturing the overlying tissue
structure to the bone fixation implant may comprise passing a
suturing needle through the overlying tissue structure and at least
some of the enclosed channels or the eyelets, respectively.
[0016] In some embodiments, the overlying tissue structure may be
sutured to the bone fixation implant by passing a suturing needle
through a region of the bone fixation implant between adjacent
openings, wherein an overall thickness of the bone fixation implant
at a rim of each opening is greater than the overall thickness in
the region between adjacent openings.
[0017] In some cases, inserting the attachment member into the
respective one of the openings may comprise thorocoscopically
monitoring the attachment member as it is inserted.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] Having thus described the invention in general terms,
reference will now be made to the accompanying drawings, which are
not necessarily drawn to scale, and wherein:
[0019] FIG. 1 shows a schematic representation of a rib cage with
bone fixation implants applied to portions of a dissected
sternum;
[0020] FIG. 2 shows a schematic representation of a rib cage with
bone fixation implants applied to a pair of ribs;
[0021] FIG. 3 shows a schematic representation of a jaw with a bone
fixation implant applied to portions of the jaw bone;
[0022] FIG. 4 shows a top view of a bone fixation implant having a
wire structural portion in accordance with an exemplary embodiment
of the present invention;
[0023] FIG. 4A shows a first cross-section of the bone fixation
implant of FIG. 4 in accordance with an exemplary embodiment of the
present invention;
[0024] FIG. 4B shows a second cross-section of the bone fixation
implant of FIG. 4 in accordance with an exemplary embodiment of the
present invention;
[0025] FIG. 4C shows the cross-section of FIG. 4B with a fastener
in accordance with an exemplary embodiment of the present
invention;
[0026] FIG. 5 shows a top view of a bone fixation implant having a
plate structural portion in accordance with an exemplary embodiment
of the present invention;
[0027] FIG. 5A shows a first cross-section of the bone fixation
implant of FIG. 5 in accordance with an exemplary embodiment of the
present invention;
[0028] FIG. 5B shows a second cross-section of the bone fixation
implant of FIG. 5 in accordance with an exemplary embodiment of the
present invention;
[0029] FIG. 6 shows a bone fixation implant having a single wire
structural portion in accordance with an exemplary embodiment of
the present invention;
[0030] FIG. 6A shows a bone fixation implant having an undulating
single wire structural portion in accordance with an exemplary
embodiment of the present invention;
[0031] FIG. 7 shows a bone fixation implant having a dual wire
structural portion in accordance with an exemplary embodiment of
the present invention;
[0032] FIG. 7A shows a bone fixation implant having an undulating
dual wire structural portion in accordance with an exemplary
embodiment of the present invention;
[0033] FIG. 8 shows a bone fixation implant configured for
attachment to a patient's sternum in accordance with an exemplary
embodiment of the present invention;
[0034] FIG. 9 shows a clos-up view of the bone fixation implant of
FIG. 8 showing a textured engaging surface in accordance with an
exemplary embodiment of the present invention;
[0035] FIG. 10 shows a bone fixation implant having a textured bone
contacting surface in accordance with an exemplary embodiment of
the present invention;
[0036] FIG. 11 shows a bone fixation implant configured for
attachment to a patient's ribs in accordance with an exemplary
embodiment of the present invention;
[0037] FIG. 12 shows a bone fixation implant configured for
attachment to a patient's facial bones in accordance with an
exemplary embodiment of the present invention;
[0038] FIG. 13 shows a bone fixation implant having a wire mesh
structural portion in accordance with an exemplary embodiment of
the present invention;
[0039] FIG. 14 shows a bone fixation implant having a wire mesh
structural portion in accordance with another exemplary embodiment
of the present invention;
[0040] FIG. 15 shows a telescoping bone fixation implant for a
spinal procedure having a cylindrical structural portion in
accordance with another exemplary embodiment of the present
invention;
[0041] FIG. 16 shows an expandable bone fixation implant for a
spinal procedure having a coil wire structural portion in
accordance with another exemplary embodiment of the present
invention;
[0042] FIG. 17 shows bone fixation implants for a longitudinal
sternal closure procedure in accordance with another exemplary
embodiment of the present invention;
[0043] FIG. 18 shows a bone fixation implant for a rib
approximation procedure in accordance with another exemplary
embodiment of the present invention;
[0044] FIG. 19 shows a bone fixation implant including enclosed
channels according to another example embodiment of the present
invention;
[0045] FIG. 20 shows a schematic side view of one of the enclosed
channels shown in FIG. 19 eyelets an example embodiment of the
present invention;
[0046] FIG. 21 shows a bone fixation implant including eyelets
according to another example embodiment of the present
invention;
[0047] FIG. 22 shows a schematic side view of one of the eyelets
shown in FIG. 21 eyelets according to an example embodiment of the
present invention;
[0048] FIG. 23 shows a bone fixation implant including a textured
tissue-engaging surface according to another example embodiment of
the present invention;
[0049] FIG. 24 shows a schematic cross-sectional view of a region
of reduced thickness according to another example embodiment of the
present invention;
[0050] FIG. 25 shows a bone fixation implant having a circular
lattice structure according to another example embodiment of the
present invention; and
[0051] FIG. 26 illustrates attachment of a bone fixation implant
according to FIGS. 19-25 to a patient's ribs for reconstruction of
a chest wall prior to attachment of the bone fixation implant to
overlying tissue structure (not shown for simplicity) according to
another example embodiment of the present invention.
DETAILED DESCRIPTION
[0052] Some embodiments of the present invention will now be
described more fully hereinafter with reference to the accompanying
drawings, in which some, but not all, embodiments of the invention
are shown. Indeed, various embodiments of the invention may be
embodied in many different forms and should not be construed as
limited to the embodiments set forth herein; rather, these
embodiments are provided so that this disclosure will satisfy
applicable legal requirements. Like reference numerals refer to
like elements throughout.
[0053] As used herein, the terms "lateral" and "laterally" refer to
a location of an anatomical structure (such as a bone) or movement
in a direction towards a point that is farthest from the center of
the respective structure. Similarly, the terms "medial" and
"medially" refer to a location or movement towards a point closest
to the center of the respective structure. The terms "upper" and
"lower" are used for explanatory purposes in the examples provided
below, where the term "upper" indicates a position or structure
that is located toward the head of a human patient with respect to
another structure and the term "lower" indicates a position or
structure that is located toward the feet of a human patient wither
respect to another structure. Furthermore, although each example
described herein refers to devices, systems, and methods for
supporting ribs, sternum portions, facial bones, and/or spinal
bones, embodiments of the described invention may be used to hold
together and/or approximate other bones, as well.
[0054] Referring now to FIGS. 1-3, different situations are shown
in which bone fixation implants may be used to support fractured or
broken bones. In FIG. 1, for example, sternal plates 10 may be used
to support two portions of a patient's sternum 15 following a
sternotomy. In the depicted scenario, two plates 10 are attached to
two portions of the dissected sternum 15, respectively, using
fasteners 20, such as bone screws. Wires 25 may then wrapped around
the plates to hold the two sternum portions together while the
sternum heals.
[0055] In FIG. 2, rib plates 30 are used to approximate a pair of
ribs 35. In this case, the plates 30 are attached, e.g., using
fasteners 40, to an adjacent pair of fractured ribs 35, spanning a
fracture 45. In addition, wires 50 may be used to support the ribs
35 with respect to each other, thereby approximating the ribs.
[0056] In FIG. 3, a facial plate 60 is used to support two portions
of a patient's jaw 65 following jaw surgery. In this case, the
plate 60 is attached to each portion of the jaw bone 65, spanning
the cut 70 that was made by the surgeon during surgery. The plate
60 may be attached to the bone using fasteners 75.
[0057] As described in the three scenarios shown in FIGS. 1-3,
often a bone fixation plate must come into contact with other
implants, such as wires and fasteners, to provide proper support at
the target site. In some cases, the plates, wires, and/or fasteners
may be made of different metals. The plate may, for example, be
made of titanium; the screws may be made of stainless steel; and
the wires may be made of stainless steel or aluminum. Direct
contact between dissimilar metals, for example in the presence of
bodily fluids, may in some cases present a risk of corrosion of one
or more of the implants. Corrosion within the body, especially at
the site of an injury, could lead to serious complications, at best
resulting in pain or discomfort to the patient and at worst
resulting in more severe injury and possibly requiring further
surgery to correct.
[0058] Accordingly, embodiments of the present invention provide a
bone fixation implant that is configured to be attached to one or
more portions of bone, in which a polymer material covers a metal
part of the implant so as to prevent direct contact of the metal of
the implant with the metal of other parts of the system, such as
the metal of the fasteners and/or of the wires that engage the
implant. In particular, and with reference to FIGS. 4-4B,
embodiments of the bone fixation implant 100 may comprise at least
one structural portion 105 comprising metal and a polymer body 110
at least partially surrounding the at least one structural portion.
The polymer body 110 may define an overall shape of the bone
fixation implant, corresponding to the outer edge 101 of the bone
fixation implant 100, which may include an overall width w, an
overall length 1, and an overall thickness t. The polymer body 110
may be configured to receive an attachment member (e.g., fastener
120 shown in FIG. 4C) therethrough for attaching the bone fixation
implant 100 to the underlying bone, as discussed in greater detail
below. The polymer body 110 may further define an engaging surface
115 that is configured to engage the attachment member as shown in
FIG. 4C, such that direct contact between the metal of the
structural portion 105 and the attachment member is prevented, as
described below.
[0059] The structural portion 105 may comprise, for example, at
least one metal such as titanium, aluminum, stainless steel, or
other biocompatible metal. The polymer body 110 may comprise any
polymer material, including, for example, shape memory polymers,
polyether ether ketone (PEEK), or other thermoplastic polymers. In
some embodiments, the polymer material may be treated or
impregnated with an additive. For example, the polymer material may
be impregnated with medication, antibiotics, growth factors, bone
stimulators, etc. Depending on the particular configuration of the
structural portion 105, as described in greater detail below, the
structural portion may be formed separately from the polymer body
110 and then embedded into or coated with the polymer material of
the polymer body to form the bone fixation implant 100. In other
embodiments, however, the polymer body 110 may be formed first and
may include grooves or channels into which the metal material of
the structural portion may be injected to form the bone fixation
implant 100.
[0060] In some cases, the structural portion 105 may comprise one
or more wires 107, as shown in FIGS. 4, 4A, and 4B. For example,
the structural portion 105 may include at least one of a flat wire
or a round wire having a diameter of approximately 0.5 mm to
approximately 3 mm. In other cases, however, the structural portion
105 may comprise a metal plate 125, as shown in FIGS. 5, 5A, and
5B, and the polymer body 110 may comprise a coating or covering
that at least partially surrounds the metal plate, such as to at
least cover areas of the plate that are configured to come into
contact with the metal components of the implant system (e.g.,
wires and/or fasteners, as described in greater detail below). In
still other cases, the structural portion 105 may be a mesh of
wires that are embedded in the polymer body, as shown in FIGS. 13
and 14 and described below.
[0061] In some embodiments, the polymer body 110 completely
surrounds the metal forming the structural portion 105 (e.g.,
completely surrounding the wires 107 as shown in FIG. 4, the plate
125 as shown in FIG. 5, or the mesh 170 as shown in FIGS. 13 and
14). In other embodiments, however, a portion of the structural
portion 105 may extend out from the polymer body 110. For example,
one end of the bone fixation implant may be configured such that
the metal of the structural portion 105 is exposed, and the exposed
portion may be configured to allow or facilitate a surgeon's
removal of part of the exposed portion. In some cases in which the
structural portion is a metal plate, for example, the exposed
portion may include notches or lines of weakness along which a
surgeon may be able to break off part of the structural portion,
such as to trim an overall length of the bone fixation implant.
[0062] Turning again to FIGS. 4-5B, 13, and 14, the polymer body
110 may define one or more openings 140 that are configured to
receive the attachment member (e.g., the fastener 120 of FIG. 4C)
therethrough. For example, the structural portion 105 may define an
inner polymeric region 116 of the polymer body 110 on one side of
the structural portion 105 and an outer polymeric region 119 of the
polymer body 110 on an opposite side of the structural portion. The
inner polymeric region 116 may define the opening 140, and the
engaging surface 115 may be defined around a circumference of the
opening, as shown. In this way, the polymer material in the inner
polymeric region 116 may be disposed between the metal material of
the attachment member passed through the opening 140 and the metal
material of the structural portion 105, such that, for example, a
fastener 120 received by the opening does not come into contact
with the structural portion in the vicinity of the opening, but
rather only engages the polymer body 110.
[0063] The opening 140 (defined by the engaging surface 115 of the
polymer body 110) may, in some embodiments, have a diameter that is
at least slightly smaller (e.g., approximately 0.5% to 15% smaller)
than a diameter of the attachment member (e.g., fastener 120) to be
received therethrough, as shown in FIG. 4C. In other cases,
however, such as in the example depicted in FIG. 5, the opening may
be a puncture that is made through a solid piece of the polymer
body 110, such that the puncture defines the engaging surface 115.
In this way, more of the polymer body 110 may be available for
engagement with the fastener 120 as the fastener is inserted
through the material of the inner polymeric region 116 via the
puncture, allowing for more secure attachment of the fastener with
the bone fixation implant and the underlying bone.
[0064] Moreover, in such cases as shown in FIGS. 4-4C and 5-5B, the
engaging surface 115 may be configured to form a seal around at
least a portion of the attachment member passing therethrough.
Thus, as the attachment member (e.g., the fastener 120, which may
be a bone screw or self-locking screw) bites through the material
of the polymer body 110 in the inner polymeric region 116 and
advances into the bone fixation implant 100 and the underlying
bone, the engaging surface 115 of the polymer body may tightly
engage and form a seal around the threads of the attachment member
(e.g., the fastener 120), thereby minimizing the amount of fluid
(e.g., blood and other bodily fluids) that may pass through the
puncture or opening 140 from one side of the bone fixation implant
100 to the other.
[0065] With reference now to FIGS. 4-7, the structural portion 105
may have various configurations (e.g., shapes and sizes) to
accommodate different types of bone fixation implants for use in
different parts of the body. For example, in FIGS. 4-4B, the
structural portion 105 comprises a wire 107 that is shaped to
correspond to the overall shape of the implant 100. Thus, in FIGS.
4-4B, the wire 107 (e.g., when considered apart from/not covered by
the polymer body 110) defines receiving portions 130 and connecting
portions 145 extending between adjacent receiving portions. At
least a portion of the structural portion 105 (e.g., the connecting
portions 145) may be substantially aligned with a central axis A of
the bone fixation implant 100. The polymer body 110, in this case,
may define the overall shape of the implant 100, including the
contours of the perimetral edge 101 of the bone fixation implant
and the thickness t of the implant (shown in FIGS. 4A and 4B).
[0066] In other embodiments, such as those shown in FIGS. 6 and 7,
at least a portion of the structural portion 105 may be
substantially aligned with an edge of the bone fixation implant
100. In FIG. 6, for example, the structural portion comprises a
single wire 107 that extends along and is substantially aligned
with a first edge 152 of the bone fixation implant 100. The second
edge 154 opposite the first edge 152 may be defined solely by the
polymer body 110. In the depicted example of FIG. 6, the bone
fixation implant 100 may be disposed within the patient's body such
that the reinforced first edge 152 is positioned to withstand any
additional forces that may be imparted on that side of the implant,
as described in greater detail below.
[0067] In some cases, as shown in FIG. 7, the structural portion
105 may comprise a first wire 107a that extends along and is
substantially aligned with the first edge 152 of the bone fixation
implant 100 and a second wire 107b that extends along and is
substantially aligned with the second edge 154 of the bone fixation
implant. In some embodiments, the first wire 107a may be longer,
thicker, and/or made of a different material than the second wire
107b. The particular configuration of each wire 107a, 107b may be
selected based on where in the body and how the bone fixation
implant 100 is to be installed. In this way, the first edge 152,
which may have greater reinforcement in the form of a longer and/or
thicker wire and/or a wire made of a stronger material, may be
disposed in a position in the patient's body so as to absorb a
greater amount of force or stress as compared to the second edge
154, which may have less reinforcement.
[0068] Furthermore, in some cases, the wires 107, 107a, and 107b,
although following a path that is substantially aligned with the
first edge 152 of the respective bone fixation implants 100, may
have an undulating curved shape, as shown in FIGS. 6A and 7A. Thus,
rather than maintaining the same distance from a respective edge
152, 154 or surface (e.g., bone contacting surface 160 shown in
FIG. 10 and described below) of the bone fixation implant along the
length of the wire 107, 107a, 107b, as shown in FIGS. 6 and 7, the
undulations in the wires shown in FIGS. 6A and 6B may instead cause
the wire to be disposed closer or farther away from the respective
edge 152, 154 or surface depending on where along the length of the
wire the distance is measured. Such undulations may, for example,
impart greater pliability to the bone fixation implant 100 so as to
allow a surgeon to shape the implant to correspond to the shape or
surface contour of the bone to which the implant is to be
fixed.
[0069] Moreover, in some embodiments, in addition to variations in
the configuration (e.g., size, shape, material, etc.) of the
structural portion 105, the configuration of the polymer body 110
may also vary depending on the intended use of the bone fixation
implant 100. Turning to FIG. 8, for example, a bone fixation
implant 100 is shown that is configured for use in longitudinal
sternal fixation (e.g., for closure of a sternal dissection such as
shown in FIG. 1). In the depicted example, the bone fixation
implant 100 is configured such that the structural portion 105
comprises a single wire 107 that extends along at least a portion
of the first edge 152 of the implant and is substantially aligned
with the first edge. The bone fixation implant 100 of FIG. 8 may be
installed on one portion of a patient's sternum 15, as illustrated
in FIG. 1, with another similarly configured (e.g., a minor image
of the bone fixation implant 100 shown in FIG. 8) attached to the
opposite portion of the dissected sternum. The implants 100 may be
oriented such that the reinforced, first edge 152 of each implant
is disposed along a lateral edge 17 of the sternum (FIG. 1).
[0070] Accordingly, in some embodiments, a first attachment member
(e.g., the fastener 120 shown in FIG. 4C) may be used to attach the
bone fixation implant to the underlying bone via the openings 140
in the polymer body 110, and the polymer body may be further
configured to receive a second attachment member (e.g., a wire 25
shown in FIG. 1) that is configured to be wrapped around the bone
fixation implants 100 and a corresponding portion of the underlying
bone to hold the sternum portions 15 together, as shown in FIG. 1.
As shown, the reinforced first edge 152 of each implant 100 (FIG.
8) may be positioned such that the wire 107 of the structural
portion 105 supports the wire 25 of the second attachment member.
In this case, the engaging surface defined by the polymer body 110
may be defined on an edge of the bone fixation implant (e.g., the
first edge 152) and may be configured to engage the second
attachment member (e.g., the wire 25), such that although the wire
107 forming the structural portion supports the attachment member
wire 25, the attachment member wire is prevented from coming into
direct contact with the structural portion due to the intervening
material of the polymer body.
[0071] To facilitate the engagement of a second attachment member
such as a wire 25, as in the scenarios depicted in FIG. 1 for a
longitudinal sternal closure and in FIG. 2 for a rib approximation
procedure, in some embodiments the engaging surface 115 of the
polymer body 110 may define a texture that is configured to enhance
engagement of the bone fixation implant 100 with the attachment
member, as shown in FIG. 9. For example, the engaging surface 115
may include knurls 117, bumps, protrusions, or other texturing
features that help the polymer body 110 grip the attachment member
(e.g., the wire 25 of FIG. 1 or the wire 45 of FIG. 2) in the
region of the first edge 152 of the implant 100.
[0072] As shown in FIG. 10, in still other embodiments, the polymer
body 110 may further define a bone contacting surface 160, and the
bone contacting surface may define a texture (e.g., knurls 117,
bumps, protrusions, or other texturing features) that is configured
to enhance engagement of the bone fixation implant with the bone on
which the implant is placed for installation. The texturing of the
bone contacting surface 160 may, for example, increase the
frictional engagement between the bone fixation implant 100 and the
surface of the bone on which the implant is to be installed, such
that the implant has less of a tendency to move with respect to the
bone during the installation process (e.g., while fasteners, such
as bone screws, are being screwed into the implant and underlying
bone). This increased frictional engagement may enhance the
stability of the bone fixation implant with respect to bone, such
that installation of the implant can be simplified and the accuracy
of the placement can be improved. In addition, the textured surface
may promote the creation of scar tissue by the patient's body,
further enhancing fixation of the implant following the procedure
as the body heals.
[0073] As noted above, the bone fixation implant 100 can be
configured in many ways to accommodate installation in various
parts of a patient's body. The bone fixation implant 100 shown in
FIG. 8, for example, is configured to be attached to a patient's
sternum (e.g., similar to what is shown in FIG. 1), whereas the
bone fixation implant 100 shown in FIG. 11 is configured to be
attached to a patient's ribs. In another scenario, the bone
fixation implant may be configured to be attached to a patient's
facial bone, such as the bone fixation implant 100 shown in FIG.
12.
[0074] In still other embodiments, the structural portion 105 may
comprise a wire mesh, as shown in FIGS. 13 and 14, and the polymer
body 110 may surround the structural portion to create a sheet-like
bone fixation implant 100 that can be used for repair of a defect
in a patient's chest wall (e.g., when a tumor is removed), for
pelvic reconstruction, and/or for reconstruction of the skull. The
configuration of the wire mesh forming the structural portion 105
may vary to accommodate different applications. In FIG. 13, for
example, the wire mesh of the structural portion 105 includes
undulations (as described above with respect to FIGS. 6A and 7A),
whereas in FIG. 14 the wire mesh of the structural portion is a
straight-line grid. Moreover, although the angles formed by the
grid in FIG. 14 are approximately 90.degree., in other embodiments
a straight-line grid may be used that forms angles between the
wires of the mesh that are greater than or less than approximately
90.degree.. The overall shape (e.g., surface area) of the mesh
embodiment of the bone fixation implant 100 shown in FIGS. 13 and
14 may be adjustable by the surgeon in some cases in which the
surgeon is able to cut or remove portions of the implant (e.g.,
portions of the polymer body 110 and/or the structural portion 105)
to achieve a desired shape. In this way, bone fixation implants 100
may be formed having different sizes and shapes of grids to
accommodate numerous different procedures in various locations
within the patient's body.
[0075] In this regard, and with reference to FIGS. 19-26, a bone
fixation implant 400 may thus be provided that has a bone engaging
surface 410 and a tissue-engaging surface 420 opposite the
bone-engaging surface. The bone fixation implant 400 may define a
plurality of openings 430 that are arranged across an overall
length L and an overall width W of the bone fixation implant, and
each opening 430 may extend through the bone-engaging surface 410
and the tissue-engaging surface 420. Each opening 430 may be
configured to receive an attachment member (e.g., fastener 120
shown in FIG. 4C) for securing the bone fixation implant to an
underlying bone structure (e.g., flail ribs or other bone structure
to be treated) such that the bone-engaging surface of the bone
fixation implant engages (e.g., contacts) the underlying bone
structure. Moreover, the bone fixation implant may be configured to
be secured to an overlying tissue structure (e.g., soft tissue
and/or muscle) such that the tissue-engaging surface 420 of the
bone fixation implant engages (e.g., contacts) the overlying tissue
structure, thereby encouraging incorporation of the tissue
structure into the bone fixation implant to promote stabilization
of the region, including the underlying bone structure, during
healing.
[0076] By engaging the overlying tissue structure with the bone
fixation implant, it is believed that the bone will heal faster.
For example, although it may take weeks or even months for bone to
heal, it may take only a few days or a week or two for muscle
and/or soft tissue to incorporate with the bone fixation implant.
With respect to fixation of ribs, for example, engagement of the
overlying tissue structure with the bone fixation implant 400 may
serve to create a new chest wall, which should reduce the pain
experienced by the patient during movement or breathing while the
ribs heal. Even if the underlying bone (e.g., the ribs) do not
fully heal, the bone fixation implant 400 as shown in FIGS. 19-26,
when used as described herein, is designed replicate the patient's
chest wall. Accordingly, embodiments of the bone fixation implant
400 may be used in the treatment of flail ribs and pectus
pathology, as well as in other locations as described above (e.g.,
the skull/scalp).
[0077] With respect to chest wall reconstruction, for example, the
material of the bone fixation implant may be selected to match the
range of motion and pliability of the chest wall, which may vary
depending on the area of the chest wall being treated. For example,
some embodiments of the bone fixation implant may include a
structural portion 105 made of titanium, aluminum, stainless steel,
Nitinol, or some other metal (e.g., in the form of a wire, a plate,
or a mesh, as described above with respect to FIGS. 13 and 14) and
may also include a polymer body, which may be made of PEEK. In
other embodiments, however, such as in applications in which
greater pliability is required, the bone fixation implant 400 may
be made predominantly or solely of a polymer, such as PEEK.
Conversely, where greater rigidity (less pliability) is required
for the particular application, the bone fixation implant 400 may
be made predominantly or solely of metal, such as titanium,
aluminum, stainless steel, Nitinol, or other biocompatible
metal.
[0078] The bone fixation implant 400 may be configured to be
secured to overlying tissue structure (e.g., via sutures) in
various ways. In some embodiments, shown in FIGS. 19 and 20, for
example, the tissue-engaging surface 420 may comprise a plurality
of enclosed channels 440 extending substantially parallel to the
bone fixation implant 400. Each enclosed channel 440 may define a
first open end 442 and a second open end 444, and a lumen 446 may
be provided between the two ends such that the enclosed channel 440
is configured (e.g., sized with an appropriate length, diameter,
and shape) to receive a suturing needle therethrough via the first
and second open ends. Thus, as shown in FIG. 20, a suturing needle
may apply a suture stitch through the overlying tissue, then be
passed through the enclosed channel 440, thereby threading a suture
thread 450 (resorbable or permanent) through the enclosed channel.
By selecting one or more of the enclosed channels 440 to receive
the suture thread 450, the overlying tissue structure can be
secured to the bone fixation implant using sutures that extend from
the tissue structure through the selected enclosed channels.
Accordingly, a number of enclosed channels 440 may be provided, as
shown in FIG. 19, and they may be arranged at different angles with
respect to one another as shown so as to provide the surgeon with
the ability to select one or more enclosed channels based on their
location and/or their orientation to match the particular
application and surgeon's methods and preferences for the given
procedure.
[0079] In other embodiments, securement to the overlying tissue may
be accomplished via eyelets 460, as shown in FIGS. 21 and 22. The
bone fixation implant 400 may, for example, include a plurality of
eyelets 460 extending outwardly from the tissue-engaging surface
420, where each eyelet is configured (e.g., sized and shaped) to
receive a suturing needle therethrough. In this way, the overlying
tissue structure may be securable to the bone fixation implant 400
using sutures 450 that extend from the tissue structure through at
least one of the eyelets 460, as shown in FIG. 22.
[0080] As noted above with respect to FIGS. 13 and 14, in some
cases the bone fixation implant may comprise at least one
structural portion 105 comprising metal and a polymer body 110
(e.g., made of PEEK) at least partially surrounding the at least
one structural portion. The polymer body 110 may define the overall
shape of the bone fixation implant, where the shape includes the
overall width W, the overall length L, and the overall thickness T
(shown, e.g., in FIGS. 19 and 21). The polymer body 110 may define
the openings 430, such that direct contact between the metal of the
structural portion 105 and the attachment member (e.g., the
fastener) is prevented.
[0081] In some cases, for example, the polymer body 110 may define
the bone-engaging surface 410, the tissue-engaging surface 420, and
the enclosed channels 440 such that direct contact between the
metal of the structural portion and any of the bone structure, the
tissue structure, or the sutures is prevented. The enclosed
channels 440 may, for example, be integrally formed with the
polymer body 110. In still other cases, the polymer body 110 may
define the bone-engaging surface 410, the tissue-engaging surface
420, and at least a portion of the eyelets 460 (e.g., via a coating
or covering of the eyelets) such that direct contact between the
metal of the structural portion and any of the bone structure, the
tissue structure, or the sutures is prevented.
[0082] In some embodiments, rather than having enclosed channels or
eyelets, the bone fixation implant itself is configured to allow a
suturing needle to be passed through the material of the implant in
certain regions to secure the overlying tissue to the implant.
Turning to FIGS. 23 and 24, for example, an overall thickness T of
the bone fixation implant at a rim 470 of each opening 430 may be
greater than the overall thickness tin a region 475 between
adjacent openings. Thus, the region 475 between adjacent openings
430 may be configured to receive a suturing needle therethrough
(e.g., due to its reduced thickness), such that the overlying
tissue structure is securable to the bone fixation implant using
sutures extending from the tissue structure through the region. In
this regard, the spacing of the openings 430, the pattern of the
arrangement of openings 430, and/or the material(s) of the bone
fixation implant (e.g., in the region 475) may be selected to allow
a suture needle to be inserted through the tissue-engaging surface
420 of the implant and out the bone-engaging surface 410, reversed
in direction, inserted through the bone-engaging surface 410 and
out through the tissue-engaging surface 420, thereby completing a
single suture stitch through the bone fixation implant 400.
[0083] Accordingly, the arrangement of the openings 430 may vary
based on the particular application (e.g., the part of the body to
be treated, etc.) to provide sufficient spacing to allow the suture
needle to maneuver and interact with the bone fixation implant as
needed. Thus, although a rectangular lattice structure is shown in
the embodiments depicted in FIGS. 19, 21, and 23, the openings 430
may be arranged to form nodes of a variety of different lattice
structures, based on the particular application and/or the
surgeon's preferences. For example, a circular lattice structure is
shown in FIG. 25, and any of a number of other different lattice
structures (e.g., triangular, pentagonal, hexagonal, etc.) may be
used.
[0084] With reference to FIG. 23, in some embodiments, at least one
of the bone-engaging surface 410 or the tissue-engaging surface 420
(and in some cases, both surfaces) may define a texture 480 that is
configured to enhance engagement of the bone fixation implant with
the underlying bone structure of the overlying tissue structure,
respectively. The texture 480 may, for example, be a roughening of
the surface, such as may be caused by knurls, one or more score
lines, protrusions, etc. formed in the respective surface. In some
cases, the enclosed channels 440 and eyelets 460 may create enough
of a texturing effect so as to promote incorporation of the
overlying tissue structure with the bone fixation implant, in which
case no additional surface texturing may be required.
[0085] Accordingly, a method of fixating bone is provided. With
respect to the repair of the chest wall of a patient, for example,
the surgeon may initially separate the muscle and/or soft tissue
from the chest wall. Fluoroscopy may be used to allow the surgeon
to see where the worst fractures are, such that the surgeon can
choose an appropriate location for the incision and identify
appropriate areas of the bone structure for attachment of the bone
fixation implant.
[0086] An appropriate bone fixation implant (e.g., appropriate size
and materials of construction) may be selected by the surgeon, and
the bone fixation implant may be applied to at least one portion of
bone, where the bone fixation implant has a bone-engaging surface
and a tissue-engaging surface opposite the bone-engaging surface,
as described above. The bone fixation implant may define a
plurality of openings arranged across an overall length and an
overall width of the bone fixation implant, and the openings may
extend through the bone-engaging surface and the tissue-engaging
surface. In some cases, the overall shape of the bone fixation
implant may be modified (e.g., adjusted) by cutting off a portion
of the bone fixation implant to correspond to a shape of an area of
the underlying bone structure to be treated.
[0087] The bone fixation implant may then be secured to the
underlying bone structure (e.g., the ribs), such as by inserting an
attachment member (e.g., a fastener, such as a self-locking screw)
into a respective one of the openings. In this way, the
bone-engaging surface of the bone fixation implant may engage the
underlying bone structure. In some cases, the insertion of the
attachment members through the openings may be monitored by the
surgeon in real time using a thorocoscopic camera to ensure that an
attachment member having the correct length has been selected.
[0088] Once the bone fixation implant has been secured to the
underlying bone structure (e.g., as shown in FIG. 26), the
overlying tissue structure may be sutured to the bone fixation
implant such that the tissue-engaging surface of the bone fixation
implant engages the overlying tissue structure. For example, a
number of sutures may be passed through the overlying tissue
structure and the bone fixation implant (e.g., via enclosed
channels, eyelets, or regions of reduced thickness), as described
above. The sutures may then be cinched by the surgeon (e.g., by
applying tension on the suture thread) to bring the overlying
tissue structure, which was previously separated from the bone
structure, into engagement with the bone fixation implant that is
now attached to the bone structure. In this way, incorporation of
the tissue structure into the bone fixation implant may be
encouraged and facilitated, which may in turn promote stabilization
of the underlying bone structure during healing.
[0089] In still other embodiments, embodiments of the bone fixation
implant 100 may comprise spacers configured for use in spinal
reconstruction procedures, such as expandable spacers that can be
inserted in a void in spinal bones to support the spine. Such voids
may, for example, be the result of a cutting away of tumors in the
spine. Examples of bone fixation implants 100 configured as
expandable spacers are shown in FIGS. 15 and 16. In FIG. 15, for
example, the bone fixation implant 100 comprises a first portion
103 and a second portion 104 configured to be received within and
expand outwardly from the first portion. Each of the first and
second portions 103, 104 may comprise a structural portion 105
comprising metal and a polymer body 110 comprising a polymeric
material such as PEEK, as described above.
[0090] In the depicted example of FIG. 15, the polymer body 110 of
each portion 103, 104 may be configured in a cup shape, and
attachment members (e.g., fasteners 120) may be provided through
the upper and lower surfaces 113, 114 of the respective portions
that are configured to attach the bone fixation implants to the
bones of the spine in the target location. The structural portion
105 provided in each of the first and second portions 103, 104 may
be configured as cylinders, such that the cylinders are able to
provide support to the bone fixation implant 100 in the direction
of expansion, while allowing the metal of the attachment members to
engage only the polymer material of the polymer body 110. Due to
the telescoping nature of the first and second portions 103, 104,
the bone fixation implant 100 may be moved to a contracted position
for insertion into the void in the spinal bone through application
of force on the upper and lower surfaces 113, 114 by the surgeon,
then moved to an expanded position to contact corresponding bone
portions within the void when the force is removed. The bone
fixation implant 100 may have a bias toward the expanded position,
for example, as a result of a spring mechanism or other feature
(not shown) configured to bias the first and second portions 103,
104 away from each other. Once in the proper location and in the
expanded position within the void, the attachment members (e.g.,
the fasteners 120) may then be used to secure the bone fixation
implant 100 within the spinal bone void.
[0091] In the embodiment shown in FIG. 16, the bone fixation
implant 100 comprises a single polymer body 110, with an embedded
structural portion 105 configured in the shape of a coil, as shown.
The structural portion 105 in this case may provide some degree of
expansion to the bone fixation implant 100, such due to a force
applied by the coil structural portion 105 that serves to bias the
upper and lower surfaces 113, 114 of the implant 100 away from each
other. In this regard, the structural member 105 may be made of a
shape memory alloy, such as Nitinol, that is configured to have a
predetermined shape within the polymer body 110 under certain
conditions (e.g., at a certain temperature). For example, when
cooled, the bone fixation implant 100 may achieve a contracted
shape that can be positioned within a void in the target spinal
bone. As the bone fixation implant 100 acclimates to the body
temperature of the patient, however, the shape memory properties of
the structural portion 105 may allow the bone fixation implant 100
to achieve an expanded shape for more fully engaging and supporting
the bone within the void (e.g., through contact of the upper and
lower portions 113, 114 with corresponding bone surfaces and/or via
the user of attachment members as shown in FIG. 15).
[0092] As described above and shown in the depicted embodiments of
FIGS. 4-16, embodiments of the bone fixation implant described
above are configured to create plating systems that can be used to
address defects and issues in various locations within a patient's
body. Depending on the particular configuration of the bone
fixation implant 100 (e.g., the overall shape of the implant, the
use of a wire structural portion versus a plate or grid structural
portion, the use of a dual wire structural portion versus a single
wire structural portion, the use of openings within the polymer
body to receive fasteners versus punctures, etc.), the bone
fixation implant may be used with attachment members in the form of
fasteners and/or in the form of wires that are wrapped around the
implant and/or the underlying bone to which the implant is
attached. The bone fixation implants 100 may be used in cranio- and
maxillofacial surgery; ortho and back surgery; chest wall
reconstruction; pelvic reconstruction; etc. Examples of medical
devices that may benefit from embodiments of the present invention
may include devices described in U.S. Patent Pub. No. 2013/0178906
titled Method and System for Longitudinal Closure of Dissected
Sternums, filed on Nov. 16, 2012; U.S. Patent Pub. No. 2013/0338719
titled Method and System for Longitudinal Closure of Dissected
Sternums, filed on Aug. 16, 2013; and U.S. Provisional Patent Appl.
No. 61/893,420 titled Device System and Method for Supporting and
Approximating Ribs, filed on Oct. 21, 2013, the contents of each of
which are incorporated by reference herein.
[0093] Turning to FIG. 17, for example, in an application in which
bone fixation implants 100 including structural portions 105 (not
shown) and polymer bodies 110 are provided for closure of a
dissected sternum, first and second bone fixation implants 100, 102
may be provided that include at least one extended region 300 and
at least one connecting portion 310, where the extended region
includes a lateral edge 320 extending away from a midline M of the
respective bone fixation implant. Each extended region 300 may be
configured to receive at least one second attachment member (e.g.,
a wire 25 shown in FIG. 1).
[0094] In some cases, for example, the extended region 300 may be
an arched region, as depicted in FIG. 17. The lateral edge 320 may,
in such cases, be rounded, as shown. Although in some embodiments
in which the lateral edge 320 is rounded the inner edge 322 of the
extended region 300 may also be a rounded edge, as illustrated, in
other embodiments the inner edge may not be rounded and may,
instead, extend in a linear fashion between either end of the
extended region. Furthermore, although the extended regions 300 are
depicted in the figures as arched regions having a rounded outer
edge 320 (e.g., in the form of an arch), in some embodiments the
extended regions may extend away from the midline M in an angular
fashion, so as to have a square, rectangular, or trapezoidal
profile, for example. Additionally or alternatively, the connecting
portions 310, in some embodiments, may be configured to have a
somewhat curved edge, such that the connecting portions may
themselves have one or more arched regions that are smaller and/or
more linear (less curvature and/or degree of lateral extension) as
compared to the arches of the extended regions 300 that may be
configured to extend past the lateral edges of the sternum
portions. The bone fixation implants 100, 102 may define openings
140 as described above that are configured to receive first
attachment members (e.g., fasteners 120 shown in FIG. 4C) for
fixing the implants to the bone, as described above.
[0095] In some cases, the extended regions 300 may comprise at
least one groove 330 configured to receive a portion of the second
attachment member (e.g., the wire 25) therein. In the depicted
embodiment, three grooves 330 are provided in each extended region
300, and each groove extends between the inner edge 322 and the
lateral edge 320 of the extended region. In other embodiments,
however, fewer or more grooves may be provided. In addition, the
groove 330 may only be provided proximate the lateral edge 320.
Moreover, the lateral edge 320 may be beveled (e.g., have a
gradually reduced thickness as compared to the inner edge 322) to
further facilitate receipt of the second attachment member 130 and
provide for a lower profile of the system.
[0096] Furthermore, in some embodiments, a distal end of the bone
fixation implants 100, 102 shown in FIG. 17 may define one or more
lines of weakness 165 configured such that the surgeon may cut or
break the material of the reinforcing member along the pre-defined
line of weakness. The line of weakness 165 may, for example, be
formed mechanically, such as via etchings, grooves, or perforations
defined in the structural portion (not shown) underlying the
polymer body. In still other cases, the polymer body 110 may not
cover portions of the structural portion defining the lines of
weakness 165, as described above.
[0097] As yet another example, in FIG. 18, another embodiment of a
bone fixation implant 100 that is configured for approximating a
pair of ribs is shown. Similar to the embodiment described above
with respect to FIG. 17, the bone fixation implant 100 comprises a
structural portion (not shown) configured in one of the ways
described above (e.g., as a wire, multiple wires, or a plate) and a
polymer body 110. As described with respect to FIG. 17, the bone
fixation implant 100 may include at least one extended region 300
and at least one connecting portion 310. In some embodiments, an
extension 380 may be provided in the vicinity of the extended
regions 300 that includes one or more additional holes 140
configured for receiving a first attachment member (e.g., a
fastener 120) therethrough. For example, as depicted in FIG. 18,
first and second extensions 380 may protrude from the connecting
portions 310 on either side of the extended region 300 therebetween
towards each other, leaving a gap 385. The gap 385 may allow the
surgeon to apply the appropriate degree of angling via the extended
region 300, as described above, while at the same time providing
additional areas for the bone fixation implant 100 to be secured to
the underlying bone.
[0098] Furthermore, the extended regions 300 may comprise one or
more holes 370 that are configured to receive a portion of the
respective second attachment member (e.g., the wire 25)
therethrough for aiding in keeping the second attachment members
from moving with respect to the bone fixation implants during
installation and following installation. For example, three holes
370 may be provided, as shown, and one or more of the holes may be
used to secure a second attachment member, as deemed necessary by
the surgeon for fixating the ribs. Moreover, in some cases, the
holes 370 may be provided in conjunction with the grooves
(described above with respect to FIG. 17), such that the surgeon
may choose which of the two methods to employ to keep the system in
place considering the condition of the patient and other surgical
variables and considerations.
[0099] In addition to minimizing reactions between different metal
components (e.g., the metal in the implant and the metal in the
fasteners), the use of a structural portion comprising metal that
is at least partially surrounded by a polymer body as described
above may also impart a certain degree of malleability and
resiliency to the bone fixation implant, which may allow the
implant to be molded by a surgeon during surgery to the shape and
contour of the patient's native bone or body structure to which the
implant is being applied. Moreover, the use of PEEK or other shape
memory polymers in the polymer body, where such materials have the
ability to return from a (temporary) deformed state to a
(permanent) original shape, may serve to relieve some of the
stresses experienced by the installed implants that may otherwise
be borne solely by the metal components of the bone fixation
implant. Furthermore, use of a polymer body as described above may
also provide for less metal to be used in the structural portion,
thereby allowing bone fixation implants having a thinner profile to
be created, which in turn may minimize the pain and discomfort
experienced by the patient as the patient heals and resumes daily
activities.
[0100] A method of fixating bone using one or more bone fixation
implants as described above is also provided. A bone fixation
implant may be applied to at least one portion of bone, where the
bone fixation implant comprises at least one structural portion
comprising metal and a polymer body at least partially surrounding
the at least one structural portion. The polymer body may define an
overall shape of the bone fixation plate comprising an overall
width, an overall length, and an overall thickness. A portion of an
attachment member may be passed through the polymer body to attach
the bone fixation plate to underlying bone, where the polymer body
defines an engaging surface configured to engage the attachment
member, such that direct contact between the metal of the
structural portion and the attachment member is prevented, as
described above.
[0101] In some cases, the attachment member may be a first
attachment member (e.g., a fastener), and a second attachment
member (e.g., a wire) may be wrapped around the bone fixation plate
and a corresponding portion of the bone. The structural portion may
define an inner polymeric region of the polymer body on one side of
the structural portion and an outer polymeric region of the polymer
body on an opposite side of the structural portion. The inner
polymeric region may define at least one opening configured to
receive the attachment member therethrough, and the portion of the
attachment member may be passed through the opening. In some
embodiments, the engaging surface may be defined around a
circumference of the at least one opening and may be configured to
form a seal around a portion of the attachment member, as described
above.
[0102] Moreover, as described above, the polymer body may comprise
polyether ether ketone (PEEK), and the structural portion may
comprise at least one of titanium, aluminum, stainless steel, or
Nitinol. In some cases, a portion of the structural portion may
extend out from the polymer body, and at least part of the portion
of the structural portion extending out from the polymer body may
be removed (e.g., broken off or cut by the surgeon) to adjust a
length of the bone fixation implant.
[0103] Many modifications and other embodiments of the invention
will come to mind to one skilled in the art to which this invention
pertains having the benefit of the teachings presented in the
foregoing descriptions and the associated drawings. For example,
although particular configurations (e.g., shapes and sizes) of bone
fixation implants are described above and depicted in the figures,
numerous other bone fixation implants configured to treat other
parts of the patient's body may benefit from embodiments of the
present invention. Therefore, it is to be understood that the
invention is not to be limited to the specific embodiments
disclosed and that modifications and other embodiments are intended
to be included within the scope of the appended claims. Although
specific terms are employed herein, they are used in a generic and
descriptive sense only and not for purposes of limitation.
* * * * *