U.S. patent application number 17/438387 was filed with the patent office on 2022-05-19 for modular orthopedic clamps.
The applicant listed for this patent is Jonathan Chang. Invention is credited to Jonathan Chang.
Application Number | 20220151671 17/438387 |
Document ID | / |
Family ID | 1000006164019 |
Filed Date | 2022-05-19 |
United States Patent
Application |
20220151671 |
Kind Code |
A1 |
Chang; Jonathan |
May 19, 2022 |
Modular Orthopedic Clamps
Abstract
An orthopedic clamp to assist in reducing the displacement
between bone ends of a fracture, and to position a fixation device,
during open fracture reduction surgery is described. The clamp
includes a holder to hold the fixation device against the bone. The
clamp may also swivel in relation to the holder while the position
of the fixation device remains unchanged. The clamp may be modular
so that components thereof may be released and/or attached.
Inventors: |
Chang; Jonathan; (Alhambra,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Chang; Jonathan |
Alhambra |
CA |
US |
|
|
Family ID: |
1000006164019 |
Appl. No.: |
17/438387 |
Filed: |
March 12, 2020 |
PCT Filed: |
March 12, 2020 |
PCT NO: |
PCT/US2020/022481 |
371 Date: |
September 10, 2021 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/8866 20130101;
A61B 17/808 20130101; A61B 2017/00955 20130101 |
International
Class: |
A61B 17/88 20060101
A61B017/88; A61B 17/80 20060101 A61B017/80 |
Claims
1. A device to assist in surgery, comprising: a first tong that
includes a distal end which is configured to engage a fractured
bone; a second tong that includes a distal end, and that is
moveably coupled to the first tong; a holder that is moveably
coupled to the distal end of the second tong and that is configured
to position a fixation plate between the holder and the fractured
bone.
2. The device of claim 1, wherein the holder includes a frame
surrounding an opening which provides access to the fixation
plate.
3. The device of claim 2, wherein the frame is sized to engage
edges of the fixation plate.
4. The device of claim 3, wherein the frame includes two sides and
two ends, and wherein the two sides form lips that engage two edges
of the fixation plate.
5. The device of claim 4, wherein the two ends form lips that
engage two other edges of the fixation plate.
6. The device of claim 1, wherein the holder is moveably coupled to
the distal end of the second tong by a swivel.
7. An orthopedic clamp for assisting with open fracture reduction
surgery, comprising: a first tong that includes a distal end which
is configured to engage a fractured bone; a second tong that
includes a release mechanism and that is moveably coupled to the
first tong; a releasable portion that is releasably attached to the
release mechanism, wherein the releasable portion includes a frame
that is rotatable relative to the second tong, and that is
configured to position a fixation plate between the frame and the
fractured bone.
8. The orthopedic clamp of claim 7, wherein the frame comprises a
radiolucent material.
9. The orthopedic clamp of claim 7, wherein the frame comprises
polyphenylsulfone, polyetherimide, polyether etherketone or a
carbon fiber reinforced polyketone or polyether etherketone.
10. The orthopedic clamp of claim 7, further comprising a swivel,
attached between the frame and the rest of the releasable portion
or second tong, wherein the swivel allows the frame to rotate
relative to the second tong.
11. The orthopedic clamp of claim 7, wherein the releasable portion
includes a swivel that is attached to the frame and that allows the
frame to be rotatable relative to the second tong.
12. The orthopedic clamp of claim 11, wherein the releasable
portion includes a pin that releasably engages the release
mechanism.
13. The orthopedic clamp of claim 12, wherein the release mechanism
includes a keyless chuck having a receptacle, wherein the pin
releasable engages the receptacle.
14. The orthopedic clamp of claim 13, wherein the cross-sectional
shape of the pin and the receptacle are non-circular.
15. The orthopedic clamp of claim 13, wherein the release mechanism
includes a secondary lock mechanism.
16. An orthopedic clamp for assisting with open fracture reduction
surgery, comprising: a first tong that includes a proximal end
having a handle and a distal end which is configured to engage a
fractured bone or bone ends; a second tong that includes a proximal
end having a second handle, a mechanism rotatably attaching the
second tong to the first tong, and a release mechanism, wherein the
release mechanism includes a keyless chuck having a non-circular
receptacle; and a releasable portion that includes: a holder which
comprises a radiolucent matter and which is configured to position
a fixation plate between the holder and the fractured bone or bone
ends; a swivel that is connected to the holder and that allows the
holder to rotate relative to the second tong; and a pin that is
connected to the swivel and that has a non-circular cross-section
which releasably engages the receptacle.
17. The orthopedic clamp of claim 16, wherein the release mechanism
includes a secondary lock mechanism.
18. The orthopedic clamp of claim 17, wherein the holder includes a
frame comprising a polyphenylsulfate, polyetherimide, polyether
etherketone or a carbon fiber reinforced polyketone or polyether
etherketone material.
19. The orthopedic clamp of claim 18, wherein the frame surrounds
an opening which provides access to the fixation plate.
20. The orthopedic clamp of claim 18, wherein the frame includes
one or more lips that engage one or more edges of the fixation
plate.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims the benefit of U.S. application Ser.
No. 16/351,417, filed Mar. 12, 2019, the contents of which are
incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The current invention generally relates to devices and
techniques to facilitate orthopedic surgeries, including clamps and
devices for use in open fracture reduction surgery to maintain a
reduction, provide alignment and/or to position an internal
fixation device during surgery. The current invention also relates
to modular clamps and devices that include releasable components
that may be detached and attached to the clamp or device, where
such releasable components may be disposable or reusable.
BACKGROUND OF THE INVENTION
[0003] When a bone is fractured, the broken bone ends and/or or
other parts of the bone may become displaced. When the displacement
is significant, surgery is often necessary to directly access the
broken bone ends and/or other bone pieces, so that the fracture may
be reduced, and so that an internal fixation device, such as a
plate, may be attached to broken bone ends and/or other bone pieces
to hold them in place while the bone heals.
[0004] In open reduction surgery, various clamps and other devices
have been used to reduce the fracture and align the broken bone
ends and/or other bone pieces so that they are in proper position
prior to attaching the internal fixation device. However, while
existing clamps may be effective in reducing the fracture, they do
not aid in attaching the plate or other internal fixation device.
Furthermore, existing clamps must typically be removed when the
internal fixation device is installed, because otherwise the clamp
would be in the way of where the internal fixation device would be
installed, or would otherwise interfere with installation.
[0005] As a result, a surgeon must remove the reduction clamps so
that the internal fixation device may be installed. This often
requires the surgeon to maintain the reduction by hand. For
example, the surgeon holds the broken bone ends together by hand
while a plate is attached to the broken bone ends with screws.
[0006] This generally results in a suboptimal process because the
reduction may not be fully maintained by the surgeon and/or the
alignment of the broken bone ends may not be maintained in an
optimal position. This process may also lengthen the duration of
the surgery which is also suboptimal because it is preferred to
reduce the time that a patient is under anesthesia.
[0007] Certain existing clamps have attempted to hold a plate in
place. However, such clamps had fixed angles and/or had a small
footprint such that they would rarely accommodate or fit a plate;
and even if they did, they would not securely hold the plate but
would instead allow it to rotate or otherwise move from its desired
position. Furthermore, such clamps have typically not been intended
for fracture reduction. Other existing clamps that have attempted
to hold a plate in place have also involved additional components,
such as temporary fixing plates, that may tend to make the overall
open fracture reduction surgery more complicated and/or longer.
[0008] Some of these other existing clamps are very invasive and
would require excessive dissection of the tissue surrounding the
fracture. Other existing clamps would simply be too large or
cumbersome to use for open fracture reduction surgery.
[0009] Accordingly, there is a need for a surgical device that
facilitates open fracture reduction surgery by assisting in the
reduction of fractures and the placement and installation of
internal fixation devices. There is also a need for a more
efficient process of performing open fracture reduction
surgery.
[0010] Existing clamps typically comprise an assembly in which all
components of the clamp are integrally attached to each other. As
such, none of the components are modular or readily detachable, if
detachable at all, from the rest of the clamp. This lack of
modularity may create issues regarding the duration and efficiency
of the open fracture reduction surgery, and patient recovery time,
as well as the cost of the open fracture reduction surgery.
[0011] For example, an x-ray may reveal a fracture before surgery.
However, the x-ray may not fully inform the surgeon of all the
circumstances inside the patient that will dictate how the
forthcoming surgery will actually be performed; e.g., circumstances
that may only be known after incisions are made in the patient and
the fracture site opened and revealed. To this end, an x-ray may
not fully apprise the surgeon of the type and/or size of the plate
or other fixation device, which should be used to reduce and secure
the fracture before incisions are made in the patient and the
fracture site is revealed.
[0012] Before surgery, a surgeon may rely on an x-ray to ready a
certain type and/or size of plate and instrument to position that
plate. But after incisions are made and the fracture site is
opened, the surgeon may see that another type and/or size of plate
and instrument is necessary. In this situation, valuable time may
be lost readying another plate and instrument. This may lengthen
the time of the surgery, and thus lengthen the time the patient is
under general anesthesia, which is generally disfavored.
Furthermore, it is common to apply a tourniquet in many orthopedic
limb surgeries. And given that the inflation pressures, duration
and release guidelines for the use of tourniquets are not entirely
established, lengthening the time that a tourniquet is applied is
also disfavored. Beyond the foregoing, increasing the surgery time
also increases costs.
[0013] Accordingly, there is a need for a modular orthopedic clamp
that would allow a surgeon to easily change components of the clamp
to address the actual requirements of the open fracture surgery to
be performed. This may occur, for example, when the actual
requirements of the surgery differ from what the surgeon assumed or
expected before opening up the patient, based on an x-ray.
[0014] The lack of modularity of existing devices may also increase
cost of the instruments needed for surgery, as well as the overall
cost of medical care. For example, the tongs of an orthopedic clamp
may generally be reusable or may be used for different types of
surgeries. On the other hand, however, the component of the clamp
which may hold the implant or fixation device in place for
attachment to the bone ends of a fracture may be suitable only for
a single use or for a specific type of surgery.
[0015] For example, the size and configuration of a plate used for
ankle surgery may differ from those of the plate used for surgery
involving larger bones. Furthermore, upon opening the patient to
review the fracture site, the surgeon may see that a different
sized or configured plate may be necessary. Still further, the
plate portion of the clamp may wear out when used for multiple
surgeries, while the tong portion may generally not wear out.
[0016] Because existing clamps generally comprise components
attached together, a surgeon or medical facility needs to have a
number of clamps available with differently sized or configured
plates for different types of surgeries, even though the tong
portion of the device could be used with different plates. Also,
where the plate wears out due to repeated use, but the tong does
not wear out, complete clamp assemblies would still need to be
maintained by the surgeon or medical facility.
[0017] Accordingly, there is also a need for a surgical device or
clamp that comprises modular components that may be detached from
each other, where certain components may be disposable and others
may be reusable or suitable for different types of surgeries.
[0018] There is also a need for an orthopedic clamp comprising
desirable materials, such as radiolucent materials, that would not
interfere with an x-ray taken, for example, during surgery to
determine whether the plate has been properly positioned over the
fracture site.
SUMMARY OF THE INVENTION
[0019] An aspect of the invention is that the surgical clamp may be
used to reduce a fracture, and to maintain the reduction, while
also including a plate holder, or frame, to hold the plate or other
internal fixation device in place for installation. This is a
significant advance because with the clamp of the current
invention, a reduction may be more easily and accurately
maintained, and the reduction need not rely on the surgeon
maintaining the reduction by hand. This is also a significant
advance because reduction clamps, unlike those currently existing,
need not be removed.
[0020] Another aspect of the invention is that different sizes and
shapes of plates and other internal fixation devices may be held in
place by the clamp. To accommodate different shapes and sizes, the
frame of the plate holder may comprise rectangles and other shapes
of different sizes. The frame may also be curved to accommodate
holding a curved plate in place. It is preferred that the frame be
sized so as to securely hold the plate or other internal fixation
device, e.g., to avoid wiggle room or rotation of the plate
relative to the frame.
[0021] Another aspect of the invention involves the frame having a
window or cutout that provides access to the bone where the screws
or other attachment means will be installed. As such, the clamp of
the current invention allows the installation of screws while
holding the internal fixation device in place, and also while
maintaining the reduction. In an alternative embodiment, the window
or cutout may be solid material with holes cutout to correspond to
where the screws or other attachment means will be installed to
secure the plate to the bone.
[0022] Another aspect of the invention involves the tool having a
swivel between the plate holder and the rest of the tool. This
allows the surgeon to swivel the frame of the plate holder to the
desired orientation along the bone, while holding the tongs of the
tool in the same place, thereby allowing the surgeon to better
maintain the reduction. In an alternative embodiment, the plate
holder may be fixedly attached to the tool. While the adjustability
of a swivel does not exist in this embodiment, the fixed
configuration may be suitable for surgery where the tool is
generally held at a certain angle.
[0023] Other aspects of the invention render the device easier to
use during surgery. For example, the tool of the current invention
preferably includes a ratchet mechanism to lock or otherwise hold
the tongs in the desired position. In this manner, pressure may be
exerted on opposite or different directions on the bone(s) thereby
maintaining the reduction and freeing up the surgeon to perform
other tasks in the surgery.
[0024] Another aspect of the invention involves making an open
reduction surgery more efficient. For example, reduction clamps
need not be removed so that the internal fixation device may be
installed. And time is not spent ensuring that the reduction is
properly maintained by the surgeon's hand before and during
installation of the internal fixation device. Time is also not
spent manipulating additional components, such as temporary plates.
As such, the duration of the surgery, and the amount of time that
the patient is under anesthesia, may be reduced. The surgery may
also be rendered less complicated thereby making the surgery more
of an optimal situation.
[0025] The current invention may also make the surgery more
efficient by aiding in the retraction of the skin to provide access
to the fracture. That is, the clamp of the current invention allows
for an upright placement on the fractured bone that may help
retract the skin, which in turn, may avoid the need for a separate
skin retractor during surgery. As such, the surgeon may perform the
surgery while having to position and/or manipulate fewer surgical
tools, which may decrease the time of surgery. Furthermore, a
person who would otherwise be required to assist in the surgery by
manipulating the skin retractor may be unnecessary.
[0026] Another aspect of the invention involves the modularity of
components comprising or included in the orthopedic clamp. To this
end, the frame or component that holds the implant or other
fixation device against the fractured bone ends may be releasable
or separable from the tongs or the rest of the clamp or surgical
instrument. The component or components that may be released from
the rest of the clamp may vary. For example, the frame and swivel
may form a releasable portion that is releasable from a tong. As
another example, the frame and swivel as well as a length of tong
may form a releasable portion that is releasable from the remaining
length of the tong.
[0027] The releasable portion may be attached and detached from one
of the tongs by different types of release mechanisms. The release
mechanism may provide the release function by mechanical, magnetic
or other means, or a combination thereof. In general, it is
preferred that the release mechanism be relatively compact so that
it does not interfere with the use of the clamp.
[0028] For example, the releasable portion of the clamp may include
a pin that engages a bored hole at the end of one of the tongs. The
pin may include a ball or bearing that engages a groove formed in
the wall of the hole. In another embodiment, the release mechanism
may include a magnetic lock with a button that, when pushed, serves
to release the releasable portion of the clamp. In another
embodiment, the release mechanism may include a sleeve with a hole
that that receives a pin of the releasable portion, wherein the
sleeve may include slots that allow the hole diameter expand or
contract. In this embodiment, the release mechanism may also
include a ring or collar that slides along the sleeve and that
serves to contract the hole diameter to tighten the sleeve and hold
the releasable portion.
[0029] In another embodiment, the release mechanism may comprise a
chuck that receives the releasable portion, and a key that serves
to tighten the chuck around the releasable portion. In other
embodiments, the release mechanism may comprise a keyless chuck,
keyless chuck with a secondary lock mechanism, wire collet, Jacobs
chuck, Trinkle chuck or any other suitable release mechanism.
[0030] It is preferred that the release mechanism allows a surgeon
to quickly and efficiently attach the desired plate or plate
assembly to the clamp, and if necessary, to release the plate or
plate assembly. The plate or plate assembly may be color coded to
help the surgeon quickly identify the desired plate or plate
assembly. It is also preferred that the release mechanism be
relatively compact so that it does not impede the other functions
of the clamp described herein.
[0031] Another aspect of the invention involves the materials
comprising the clamp. For example, the frame that holds the plate
or other fixation device to the fractured bone ends may comprise
carbon fiber or some other radiolucent material, so that the bones
under the clamp may be visible on an x-ray. The tong portion of the
clamp may also comprise a radiolucent material.
[0032] In another aspect of the invention, the components of the
clamp assembly and/or plate or other fixation device may be colored
differently. For example, a certain sized plate may be configured
to work with a certain clamp/plate. Where they are both the same
color, and other clamp/plate combinations are other colors, the
color difference allows the surgeon to more quickly identify the
surgical instrument and implant to use. In another aspect of the
invention, the releasable portion of the clamp may be
disposable.
[0033] Other aspects of the invention are discussed herein.
BRIEF DESCRIPTION OF THE DRAWINGS
[0034] FIG. 1 is a picture showing existing fracture reduction
clamps and an internal fixation device comprising a plate.
[0035] FIG. 2 is a side perspective view of a clamp and fixation
device holder.
[0036] FIG. 3 is a side perspective view of a clamp and fixation
device holder.
[0037] FIG. 4 is a rear perspective view of a clamp and fixation
device holder.
[0038] FIG. 5 is a front perspective view of a clamp and fixation
device holder.
[0039] FIG. 6 shows a clamp and fixation device holder during
surgery.
[0040] FIG. 7 shows an orthopedic clamp with a releasable portion
including a plate holder assembly and part of a tong, and a release
mechanism.
[0041] FIG. 8 shows an exploded view of a release mechanism
involving a pin and ball that engages a bored hole. FIG. 8A is a
side view of the release mechanism of FIG. 8. FIG. 8B is a section
view of the release mechanism of FIG. 8.
[0042] FIG. 9A shows an exploded view of a release mechanism
involving a magnetic lock and release button. FIG. 9B shows the
release mechanism of FIG. 10A engaging the releasable portion.
[0043] FIG. 10A is an exploded view of a release mechanism
involving an expandable sleeve and sliding ring. FIG. 10B shows the
release mechanism of
[0044] FIG. 10A engaging the releasable portion.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0045] The current invention is now described with reference to the
figures. FIG. 1 shows several existing types of clamps, as well as
an existing internal fixation plate. Generally, the existing clamps
may be used to reduce the fracture, and maintain the reduction, but
at least one of the tongs will be in the way of installing the
plate. Accordingly, these existing clamps must typically be removed
in order to install the plate.
[0046] As noted above, this requires the surgeon to maintain the
reduction by hand while also positioning the plate and holding the
plate in place while installing the screws or other attachment
means used to fix the plate before the patient is closed. This is a
suboptimal process because the integrity of the reduction or the
alignment of the broken bone ends or other bone pieces may be lost
or reduced. This is also a suboptimal process because it is
inefficient and may increase surgery time and the time that the
patient is under anesthesia.
[0047] Referring to FIGS. 2-5, the current invention is now
described in more detail. Orthopedic clamp or device or tool 10 may
include first or lower tong 20 and second or upper tong 30 that may
be moveably coupled to each other. First or lower tong may include
distal or tong end 22 which, when tool 10 is used, may engage the
bone being reduced and may serve to press from a first direction,
e.g., the underneath or the bottom of a reduction, or the distal
side of the reduction located away from the surgeon. Tong end 22
may include serrated section 22A to help it securely engage the
bone to be reduced.
[0048] Distal or tong end 22 may comprise a curved and/or tapered
end, which allows it to be placed on the distal, opposite or other
side of the bone to be reduced and plated without needing to
dissect more soft tissue around or from that side of the bone. This
may generally improve the healing potential of the fracture.
[0049] In an alternative embodiment, distal or tong end 22 may be
configured to include a rectangular or curved piece that may
support more of a length of the distal, underside or other side of
the bone(s). Lower tong 20 may also include a handle having a
finger hole 24 and positioning or locking stem 26. Stem 26 may
include a series of ridges, peaks/valleys or teeth 26A, 26B,
etc.
[0050] Second or upper tong 30 may include distal or tong end 32,
and a handle having finger hole 34 and positioning or locking tab
36. Tab 36 may include one or more ridges or high points 36A, 36B,
etc. that may engage with the teeth 26A, 26B, etc. of stem 26 to
lock the tool 10 in a desired configuration. Tongs 20, 30 may be
moveably coupled to each other or joined by a threaded screw
arrangement or other form of attachment 40 that preferably allows
tongs 20, 30 to move or rotate relative to each other about
attachment 40. In a preferred embodiment, stem 26 and tab 36
comprise a ratchet to lock or hold tongs 20, 30 in the desired
position once determined by the surgeon.
[0051] The distal end 32 of upper tong 30 may interface with
holder, insert or cutout assembly 50 that may be configured to hold
or position a plate or other fixation device in the location at
which it will be attached to the fractured bone(s).
[0052] Holder 50 may include frame or cutout 52 that may be
attached to tong end 32 via swivel 80. Frame 52 may generally serve
to position the plate 90 (as shown in FIG. 6) or other internal
fixation device, as well as to hold plate 90 in place on bone 92
while screws or other attachment means are installed. That is,
plate 90 may be held between frame 52 and the bone 92 so that tool
10 presses plate 90 towards the bone 92 in the desired location so
as to securely hold it in place. In this manner, when the surgeon
squeezes tong handles 24, 34 together, frame 50 and distal end 22
exert forces in opposite or other directions towards each other
which serves to maintain the reduction and hold plate 90 in place
for installation.
[0053] In this manner, the current invention represents an advance
over certain existing tools that may provide a socket in which to
position the plate, e.g., the device shown at the link below:
[0054]
http://www.innomed.net/smallbone_footankle_clamps.htm#DuncanClampFt
[0055] However, in those existing tools, the plate merely rests on
top of the tool and is not clamped between the tool and the bone.
As such, the plate is not securely held in place with respect to
the bone. Furthermore, in these existing tools, the plate may
rotate or wiggle relative to the tool which further adds to issues
because the plate is not securely held in place.
[0056] To facilitate the swiveling of frame 52 relative to upper
tong 30, tong end 32 may include threaded hole 38 and plate holder
assembly 50 may include tab 58. The swivel 80 attachment between
tab 58 and hole 38 may comprise a bolt or screw (as shown in FIGS.
2 and 4), bearing, bushing or other attachment mechanism that
allows frame 52 to swivel relative to upper tong 30. It is
preferred that the attachment mechanism allows the smooth swiveling
of frame 52 relative to tong 30 so that tool 10 may be swiveled
without disrupting the position of plate 90. As discussed in more
detail later, the swiveling capability allows clamp 10 to maintain
the reduction while allowing the surgeon a degree of freedom in
placing the plate or other internal fixation device, and to perform
other tasks such as installing the screw to attach the plate to the
bone(s).
[0057] Frame 52 may be configured to accommodate various shapes and
sizes of plates or other internal fixation devices. It is preferred
that frame 52 engage at least some of the edges of the plate while
providing access to the upper surface of the plate, i.e., it is
preferred that frame 52 surround a "window" or opening 52A that
allows access to the part of the plate within the perimeter of
frame 52 as it engages the reduced bone ends. This allows the
surgeon to install screws or other attachment means within window
52A and through the plate and into the bone. Additionally, frame 52
securing plate 90 to the bone(s) also allows the surgeon to install
screws outside the perimeter of frame 52.
[0058] In the embodiment of tool 10 shown in FIGS. 2-5, frame 52
may be shaped as a rectangle comprising sides 54A, 54B and ends
56A, 56B. This configuration may be preferred for a fibular
fracture reduction. The lengths of sides 54A, 54B and/or the ends
56A, 56B may be varied to accommodate different sized rectangular
plates. However, frame 52 may comprise other shapes and sizes.
Furthermore, frame 52 may be curved in both the longitudinal and/or
transverse dimension(s) to accommodate curved plates or other
internal fixation devices. Accordingly, tool 10 of the current
invention is not limited for use with fibular fractures. Indeed,
clamp 10 of the current invention may be used for open reduction
surgeries on a number of other bones with their own particular
shapes, sizes and/or configurations.
[0059] As best shown in FIGS. 2-4, frame sides 54A, 54B may extend
downward to form lip 59 that may help contain and position the
plate to be installed. This is in addition to the fact that tool 10
pushes the plate towards the bone(s). As such, tool 10 provides a
secure placement and positioning of the plate unlike prior
devices.
[0060] In the embodiment shown in FIGS. 2-5, frame ends 56A, 56B do
not have lip 59, and the plate to be installed may extend beyond
frame 52. However, in other embodiments, lip 59 may extend around
the periphery of frame 52 thereby providing a "socket" type holder
for the plate being installed.
[0061] Beyond the unique and innovative characteristics of tool or
clamp 10 described above, the current invention also provides for a
safer, more accurate and more efficient way to conduct an open
fracture reduction surgery. To this end, the current invention
fills an unmet need for a device that may reduce the fracture, and
then better maintain the fracture reduction while also holding the
repair plate or other fixation device in its proper position at the
same time without having to remove the reduction clamps. As noted
above, this may generally eliminate the human aspect of maintaining
the reduction by hand, which may lead to misalignment and also
prolong the length of the surgery and the time the patient is under
anesthesia.
[0062] Furthermore, the swiveling 80 of holder or frame 52 with
respect to tong 30 preferably holds the plate against the bone
while the angled opposite tip 22 allows for positive tightening
without the need for any further soft tissue dissection. By holding
onto the plate itself, the reduction will not be lost while
positioning the properly sized plate on the reduced fracture, and
window 52A also allows for drilling of multiple holes in the plate
under frame 52 without moving clamp 10. This improves upon current
available equipment that does not allow any of these maneuvers to
occur.
[0063] FIG. 6 shows tool 10 in use during an open fracture
reduction surgery of a fractured fibula 92. As shown, tool 10 is
positioned in the desired location to both reduce the fracture and
locate the plate or other fixation device for installation. Once
tool 10 is thus positioned, the ratchet mechanism 26, 36 holds
tongs 20, 30 in a fixed position relative to each other.
[0064] As also shown in FIG. 6, distal or tong end 22 helps
maintain reduction of the fracture by pressing it towards the
surgeon from the other side of the bone. Because distal or tong end
22 may be configured as a tapered and pointed end, it can be seen
how further dissection of the tissue around the fibula need not be
further dissected, which would be the case if tong end 22 were
configured with a transverse piece (that would be axially aligned
with the fibula).
[0065] The current invention may also make the surgery more
efficient by aiding in the retraction of the skin to provide access
to the fracture. That is, the clamp 10 of the current invention
allows for an upright placement on the fractured bone 92 that may
help retract the skin, which in turn, may avoid the need for a
separate skin retractor during surgery. To this end, the section or
strut 22 of tong 20 that may be positioned on the distal side of
the reduced fracture may be in contact with, and help retract, the
skin on that side of the incision that may help avoid the need for
a separate skin retractor. Similarly, the section or strut 32 of
tong 30 may also help retract the skin when it is in contact with
the skin.
[0066] As such, the surgeon may perform the surgery while having to
position and/or manipulate fewer surgical tools, thereby decreasing
the time of the surgery. Furthermore, an assistant who would
otherwise be required to manipulate the skin retractor may be
unnecessary.
[0067] Frame 52 preferably secures plate 90 against the fibula 92.
As shown, window or cutout 52A provides ready access to plate 90
and plate holes 92 through which screws or other attachment means
may be installed. In addition, frame 52 holds plate 90 in place
while plate holes 92 outside of frame 52 are also accessible.
[0068] The unique benefit of swivel 80 is also shown in FIG. 6.
That is, once frame 52 and plate 90 are located in the desired
position, swivel 80 allows tool 10 to be rotated relative to frame
52 without moving plate 90. To this end, it is preferred that the
swivel connection 80 allows the smooth and/or unhindered rotation
of tool 10 relative to frame 52 and plate 90 so that plate 90 may
remain in the desired located while tool 10 is swiveled. The smooth
swiveling operation may be provided by a bearing, bushing, nut/bolt
or other suitable mechanisms. Maintaining the position of plate 90
while swiveling tool 10 may be desired especially where screw holes
may have been drilled into the bone to be plated, and it is optimal
for plate 90 to remain in the position so that the screw holes in
plate 90 match up with screw holes drilled into the bone.
[0069] The swiveling capability of tool 10 may also be facilitated
by distal or tong end 22 being tapered or pointed, because the tip
of distal end 22 may contact the bone and still rotate relative
thereto without cutting into any surrounding tissue and/or
requiring any further dissection. The swiveling capability of tool
10 is beneficial, for example, to provide more space for the
surgeon to install the screw and to manipulate the tools necessary
to do so.
[0070] The frame 52 and its lip 59 are preferably configured in a
curved fashion, i.e., curved along its ends 56A, 56B to correspond
to and better hold a curved plate 90 that is, in turn, configured
to generally correspond to the curvature of the fibula or other
bone to be plated. Furthermore, the foregoing may all occur while
tool 10 maintains the fracture reduction and does not require
removal of reduction clamps and/or require the surgeon to maintain
the reduction by hand while installing the plate 90. To this end,
the locking ratchet connection 26, 36 may keep tongs 20, 30 in the
desired locked position so as to maintain pressure from opposite or
different directions against the bone(s). In this manner, the
reduction is maintained while the surgeon is free to concentrate on
the tasks associated with fixing plate 90 to the bone(s).
[0071] Embodiments of the current invention where clamp 10 is
modular where certain components are releasable from the rest of
clamp 10 are now described with reference to FIGS. 7-10. Generally,
it is preferred that plate holder assembly 50 may be releasable
from the rest of clamp 10. However, other or additional components
or parts of clamp 10 may also be releasable. Regardless of what
components comprise the releasable portion, it is preferred that
the releasable portion may be readily attached or detached from
clamp 10. This way, when the desired plate 90 has been chosen, the
appropriate plate holder assembly 50 that corresponds to that plate
90, may be readily installed on clamp 10. This preferably reduces
the time of surgery and time that the patient is under anesthesia.
The efficient installation of the releasable portion may be
especially beneficial when opening up the fracture site reveals
that the plate 90 and plate holder assembly 50 that should be used
is different than what might have been expected based on the
pre-surgery x-ray.
[0072] As noted above, the components which may comprise the
releasable portion may vary. FIG. 7 shows the releasable portion
100 as comprising plate holder assembly 50, as well as swivel 80
and tong end 32 (or a part of the distal portion of upper tong 30).
Releasable component 100 may be detached and attached to clamp 10
by release mechanism 110. Different types of release mechanisms 110
of the current invention are described below.
[0073] Alternatively, releasable component 100 may comprise plate
holder 50, tab 58 and swivel 80 as shown in FIGS. 8, 8A and 8B. In
this embodiment, releasable component 100 does not include tong end
32; instead, releasable component 100 may be detached from tong end
32. It is preferred that plate holder assembly 50 may still swivel
relative to tong end 32.
[0074] In this embodiment, release mechanism 110 may include pin 82
that extends from tab 58 and swivel 80 and that engages hole 32A
located at or near distal end 32. Pin 82 may be inserted into hole
32A, but may also be released therefrom. As such, pin 82 may
replace the bolt or screw or other attachment means mentioned
above; and hole 32A may replace the threaded hole 38. The wall of
hole 32A may also include a groove 32B.
[0075] Different types of release mechanisms 110 may exist between
swivel 80 and distal end 32, but in an embodiment shown in FIGS.
8A-8B, pin 82 may include a hole or bore 83 that extends laterally
and that accommodates a ball bearing 84 that may protrude from the
surface of pin 82. Ball bearing 84 may be spring loaded, i.e., a
spring 85 may be positioned between the ball bearing 84 and the end
of bore 83 so that ball bearing 84 is biased outward and protrudes
from the surface of pin 82.
[0076] When pin 82 is initially inserted into hole 32A, ball
bearing 84 may be pushed inward so that pin 82 may be further
inserted into hole 32A. However, when pin 82 has been sufficiently
inserted, ball bearing 84 may engage groove 32B. The bias of spring
85 may push ball bearing 84 into groove 32B thereby securing
releasable portion 100 to clamp 10.
[0077] Groove 32B may extend around the circumference of the wall
of hole 32A so that ball bearing 84 may slide therein, thereby
allowing frame holder assembly 50 to rotate relative to clamp 10.
As such, pin 82 may be fixedly secured to swivel 80 because the
rotation may be provided between ball 84 and groove 32B.
Alternatively, a swivel arrangement 80 may exist between pin 82 and
tab 58.
[0078] It is preferred that the force exerted by spring 85 is
sufficient to ensure that the engagement between releasable portion
100 and clamp 10, i.e., the release mechanism 110, is sufficiently
secure to withstand the forces exerted by the surgeon during
surgery so that frame 52 securely positions plate 90 over the
fractured boned ends. It is also preferred that releasable portion
100 may still be readily detached from tong end 32. That is, it is
preferred that the bias of spring 85 is not so great so as to
prevent ball bearing 84 from being retracted into bore 83 when the
surgeon pulls up on releasable portion 100 to detach it from tong
end 32.
[0079] In an alternative of the embodiment shown in FIGS. 8, 8A and
8B pin 82 extends from tong end 32 and a hole with a groove is
formed in tab 58/swivel 80. This embodiment operates similarly as
in FIGS. 8, 8A and 8B, where the components of release mechanism
110 are inverted.
[0080] Another embodiment of release mechanism 110 that comprises a
magnetic lock 120 is now described with reference to FIGS. 9A and
9B. In this embodiment, releasable portion 100 may comprise plate
holder assembly 50, tab 58, swivel 80 and a portion of distal end
32 of tong 30, as well as insertion end 126. Insertion end 126
preferably comprises a ferrous material that is attracted by a
magnetic field. Magnetic lock 120 may include a receptacle 124 that
receives the insertion end 126. Magnetic lock 120 may also include
an electromagnet through which an electric current may pass. The
current, which may be provided by a battery or other power source
(not shown), creates a magnetic charge that attracts the ferrous
insertion end 126, thereby locking it in place within receptacle
124 as shown in FIG. 9B.
[0081] Magnetic lock 120 may include a release button 122 that may
be pressed to release insertion end 126 from receptacle 124. When
release button 122 is pressed, it may interrupt the current,
thereby removing the magnetic field that attracts insertion end
126, thereby allowing releasable portion 100 to detach from clamp
10.
[0082] Another embodiment of release mechanism 110 that comprises a
collet 130 is now described with reference to FIGS. 10A and 10B. In
this embodiment, releasable portion 100 may comprise plate holder
assembly 50, tab 58, swivel 80 and a portion of distal end 32 of
tong 30, as well as insertion end 136. Collet 130 may include
tapered receiving sleeve 132, e.g., Morse Taper, that may include
springs 133A and slots 133B around its circumference, where the
ends of springs 133A form receptacle 134. Springs 133A may extend
radially outward along their length to their ends. Collet 130 also
includes ring or other clamping device 135 that may slide along the
length of sleeve 132.
[0083] After insertion end 136 is inserted into receptacle 134,
ring 135 may be moved distally thereby clamping down on springs
133A, thereby decreasing the diameter of receptacle 134, which in
turn clamps down on insertion end 136. This preferably secures
insertion end 136 within sleeve 132, and thus secures releasable
portion 100 within collet 130 as shown in FIG. 10B.
[0084] Ring or other clamping device 135 may be spring-biased
distally. As such, the surgeon may retract ring 135 proximally,
insert releasable portion 100, i.e., insertion end 136, into
receptacle 134, and then release ring 135 which secures releasable
portion 100 to clamp 10 as it moves distally along sleeve 132. To
detach releasable portion 100 from clamp 10, the surgeon may
retract ring 135, thereby allowing springs 133A to expand and to
release their grip on insertion end 136.
[0085] In a preferred embodiment, the shape of the pin of frame
assembly 50 that is inserted into the receptacle of the release
mechanism, as well as the shape of the receptacle that receives the
pin may be something other than circular. This way the pin
preferably does not rotate within the receptacle after the release
mechanism is locked.
[0086] As noted above, the current invention is not limited to the
release mechanisms 110 shown in FIGS. 9-10. Instead, the current
invention includes any mechanism that may readily release the
component(s) comprising releasable portion 100 so as to facilitate
efficient surgeries, and preferably reduce surgery time and time
during which the patient is under anesthesia. It is also preferred
that the quick release mechanism be compact or otherwise not
interfere with the use of clamp 10. In a preferred embodiment, a
keyless drill chuck with a secondary lock mechanism may be
used.
[0087] The current invention may provide these benefits especially
where the actual circumstances and requirements of the surgery are
revealed only after incisions are made and the fracture site is
opened, and these actual circumstances and requirements turn out to
be different than what the pre-surgery x-ray indicated. In this
situation, the modularity of the current invention allows the
surgeon to quickly adapt by readily changing the plate and plate
holder that are necessary for the surgery.
[0088] The modular nature of clamp 10 provides advantages beyond
efficiency and reduced time for surgery. For example, releasable
portion 100 may be suitable for only one or a limited number of
surgeries because the forces exerted on it by the surgeon when
reducing a fracture and maintaining the reduction while the plate
is installed may damage or otherwise wear out the frame 52 or frame
holder assembly 50. Furthermore, it may be more economical to
dispose of the releasable portion 100 rather than sterilize it for
additional use in additional surgeries. However, the rest of clamp
10 may be readily reusable for multiple surgeries because, e.g., it
is less prone to damage or wearing out. Because the tongs 20, 30
and the rest of clamp 10 have a cost associated with them, the fact
that they may be reused while the releasable portion is disposed of
represents a cost savings. That is, rather than discard the entire
clamp 10, only the releasable portion 100 may be discarded.
[0089] The modularity of the current invention may also provide
cost savings as follows. While the releasable portion 100 may be
suited for only certain types of surgeries, e.g., reducing
fractures and installing plate 90 on certain size bones, the tongs
20, 30 and the rest of clamp 10 may be suited to use for different
types of surgeries. That is, a given set of tongs 20, 30 may be
used with different types of frames 50 to install different types
of plates 90. The modularity of the current invention avoids the
need for purchasing a complete clamp 10 for each type of surgery.
Instead, only the releasable portions 100 may need to be
purchased.
[0090] For example, the current invention is suitable for
installing plates 90 for various types of fractures, e.g., fibula,
tibia, tibia plateau, femur, supra condylar femur, forearm, humerus
and clavicle. A number of differently sized plates 90, and thus a
number of differently sized or configured frames 50 (and releasable
portions 100) may be needed to perform these surgeries. However, a
given set of tongs 20, 30 may be reused for some number of these
different types of surgeries. And even where a given set of
different types of surgeries may require more than one set of tongs
20, 30, the current invention still allows a surgery center,
hospital or other facility to avoid purchasing a set of tongs 20,
30 for each different type of surgery.
[0091] The materials from which components comprising releasable
portion 100 and clamp 10, as well as plate 90, are made are now
further described. In certain surgeries, it may be desirable to
take an x-ray while the surgery is being performed and while
releasable portion 100 and/or other parts of clamp 10 may be within
the patient. Also, x-rays are typically taken after surgery to
gauge healing. However, plates and other fixation devices, as well
as the clamps used to install them, have typically been made of
metals which are opaque to x-rays and thus obstruct the x-ray
visibility of, e.g., the position of fractured bone ends that may
be located behind a plate or the clamp used to install the
plate.
[0092] To address the foregoing drawbacks, frame holder assembly 50
and/or other components comprising releasable portion 100 or clamp
10 may comprise radiolucent materials such as polyether ether
ketone (PEEK) or carbon-fiber reinforced materials. These materials
do not interfere with medical imaging provided by MRI, CT and x-ray
scans. As such, the materials comprising the current invention
preferably allow an x-ray taken during surgery to provide, for
example, a clear image of the positioning of the fractured bone
ends during open reduction surgery. It is also preferred that the
translucent materials comprising frame holder assembly 50,
releasable portion 100 and/or clamp 10 reflect sufficient strength
while avoiding excess brittleness. For example, carbon fibers are
very brittle, but the current invention includes the use of
carbon-fiber reinforced thermoplastics. This composite material
provides sufficient strength as well as an amount of
flexibility.
[0093] The materials that may comprise clamp 10 are now more fully
described. In an embodiment of the current invention, clamp 10 may
comprise surgical stainless steel, including tongs 20, 30 and frame
assembly 50. Alternatively, such as in embodiments including a
releasable portion 100, tongs 20, 30 may still comprise surgical
stainless steel and frame assembly 50 and/or releasable portion 100
may comprise polyphenylsulfone (PPSU), polyetherimide (PEI),
polyetheretherketone (PEEK) or carbon fiber reinforced polyketone
or polyether etherketone.
[0094] Such materials may be used because they provide a
combination of strength to withstand the clamping forces exerted by
the surgeon, flexibility to avoid excessive brittleness,
biocompatibility, and as noted above, radiolucency.
[0095] Although certain presently preferred embodiments of the
invention have been described herein, it will be apparent to those
skilled in the art to which the invention pertains that variations
and modifications of the described embodiments may be made without
departing from the spirit and scope of the invention.
* * * * *
References