U.S. patent application number 17/233828 was filed with the patent office on 2021-08-05 for orthopedic compression plate and method of surgery.
This patent application is currently assigned to ORTHOHELIX SURGICAL DESIGNS, INC.. The applicant listed for this patent is ORTHOHELIX SURGICAL DESIGNS, INC.. Invention is credited to Elizabeth ALTENAU, Gordon BENNETT, Bryan D. DEN HARTOG, Jackson R. HEAVENER, Brian HOCKETT, Jeffrey JOHNSON, David B. KAY, Andrew LEITHER, Derek S. LEWIS, Ellen POKORNEY, Allison WRIGHT.
Application Number | 20210236182 17/233828 |
Document ID | / |
Family ID | 1000005524873 |
Filed Date | 2021-08-05 |
United States Patent
Application |
20210236182 |
Kind Code |
A1 |
LEWIS; Derek S. ; et
al. |
August 5, 2021 |
ORTHOPEDIC COMPRESSION PLATE AND METHOD OF SURGERY
Abstract
An orthopedic plate has a first end including a locking screw
hole that receives a locking screw and spaced from that hole is a
closed compression housing that extends from the bone-facing side
of the plate and which receives a compression screw that forms an
angle of from about 10.degree. to about 70.degree. with a
longitudinal axis of the plate. The compression housing is not
located on the medial line of the plate, but is peripheral to the
medial line, either in the longitudinal or the medial direction of
the plate.
Inventors: |
LEWIS; Derek S.; (Copley,
OH) ; ALTENAU; Elizabeth; (Lakewood, OH) ;
BENNETT; Gordon; (Wadsworth, OH) ; DEN HARTOG; Bryan
D.; (St. Paul, MN) ; HEAVENER; Jackson R.;
(Warsaw, IN) ; HOCKETT; Brian; (Parma, OH)
; JOHNSON; Jeffrey; (Chesterfield, MO) ; KAY;
David B.; (Akron, OH) ; LEITHER; Andrew;
(Akron, OH) ; POKORNEY; Ellen; (Plymouth, MN)
; WRIGHT; Allison; (Scottsdale, AZ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ORTHOHELIX SURGICAL DESIGNS, INC. |
Bloomington |
MN |
US |
|
|
Assignee: |
ORTHOHELIX SURGICAL DESIGNS,
INC.
Bloomington
MN
|
Family ID: |
1000005524873 |
Appl. No.: |
17/233828 |
Filed: |
April 19, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16251891 |
Jan 18, 2019 |
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17233828 |
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15445242 |
Feb 28, 2017 |
10213236 |
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16251891 |
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14713401 |
May 15, 2015 |
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15445242 |
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13728532 |
Dec 27, 2012 |
9060822 |
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14713401 |
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13372902 |
Feb 14, 2012 |
9005255 |
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13728532 |
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61580680 |
Dec 28, 2011 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/8605 20130101;
A61B 17/8095 20130101; A61B 17/8057 20130101; A61B 17/8014
20130101; A61B 17/8061 20130101 |
International
Class: |
A61B 17/80 20060101
A61B017/80; A61B 17/86 20060101 A61B017/86 |
Claims
1. A surgical plate, comprising: a body extending between a top
surface, a bottom surface, a proximal end, and a distal end; a
first tab and a second tab formed integrally with a proximal end of
the body, wherein the first tab and the second tab each define a
hole extending from the top surface to the bottom surface, wherein
the hole is sized and configured to receive a screw therethrough;
and a compression housing extending from a bottom surface of the
plate, wherein an opening is defined from the top surface of the
plate to a surface of the compression housing.
2. The surgical plate of claim 1, wherein the first tab and the
second tab are symmetrical with respect to the body.
3. The surgical plate of claim 1, wherein the hole defined in each
of the first tab and the second tab comprise threaded locking
holes.
4. The surgical plate of claim 3, wherein the hole defined in each
of the first tab and the second tab is sized and configured to
receive a locking screw therein.
5. The surgical plate of claim 1, wherein the compression housing
comprises a rectangular flat proximal surface and a plurality of
flat side walls.
6. The surgical plate of claim 4, wherein the opening defined in
the surface of the compression housing is defined through one of
the plurality of flat side walls.
7. The surgical plate of claim 1, wherein the opening is sized and
configured to receive a shaft of a compression screw
therethrough.
8. The surgical plate of claim 1, wherein the distal end of the
body comprises a chamfer configured for insertion into a bone.
9. The surgical plate of claim 1, wherein the distal end of the
body comprises an elongated tab.
10. A system, comprising a surgical plate, comprising: a body
extending between a top surface, a bottom surface, a proximal end,
and a distal end; a first tab and a second tab formed integrally
with a proximal end of the body, wherein the first tab and the
second tab each define a hole extending from the top surface to the
bottom surface, wherein the hole is sized and configured to receive
a screw therethrough; and a compression housing extending from a
bottom surface of the plate, wherein an opening is defined from the
top surface of the plate to a surface of the compression housing;
at least one locking screw sized and configured to be received
within the hole defined in each of the first tab and the second
tab; and at least one compression screw sized and configured to be
received within the opening.
11. The system of claim 10, wherein the first tab and the second
tab of the surgical plate are symmetrical with respect to the body
of the surgical plate.
12. The system of claim 10, wherein the hole defined in each of the
first tab and the second tab comprise threaded locking holes.
13. The system of claim 10, wherein the compression housing
comprises a rectangular flat proximal surface and a plurality of
flat side walls.
14. The system of claim 13, wherein the opening defined in the
surface of the compression housing is defined through one of the
plurality of flat side walls.
15. The system of claim 10, wherein the opening comprises a first
opening formed in the plate having a first diameter and a second
opening formed in the compression housing having a second diameter,
wherein the second diameter is less than the first diameter.
16. The system of claim 10, wherein the first diameter is greater
than a diameter of a head of the compression screw and the second
diameter is less than the diameter of the head of the compression
screw but greater than a diameter of a shaft of the compression
screw.
17. The system of claim 10, wherein the distal end of the body
comprises a chamfer configured for insertion into a bone.
18. The system of claim 10, wherein the hole defined in each of the
first tab and the second tab is sized and configured to receive a
head of the locking screw therein.
19. A surgical plate, comprising: a body extending between a top
surface, a bottom surface, a proximal end, and a distal end, the
body defining a first opening extending from the top surface to the
bottom surface; a first tab and a second tab formed integrally with
a proximal end of the body, wherein the first tab and the second
tab each define a hole extending from the top surface to the bottom
surface, wherein the hole is sized and configured to receive a
screw therethrough; and a shroud extending from a bottom surface of
the plate, wherein the shroud defines a second opening extending
from the bottom surface of the plate to a surface of the shroud,
and wherein the first opening defined in the plate and the second
opening defined in the shroud are concentric.
20. The surgical plate of claim 19, wherein the first opening has a
first diameter and the second opening has a second diameter, and
wherein the second diameter is less than the first diameter.
Description
CROSS REFERENCE
[0001] This application is a continuation of U.S. patent
application Ser. No. 16/251,891, filed on Jan. 18, 2019, entitled
"Orthopedic Compression Plate and Method of Surgery," which is a
continuation of U.S. patent application Ser. No. 15/445,242, filed
Feb. 28, 2017, entitled "Orthopedic Compression Plate and Method of
Surgery," now U.S. Pat. No. 10,213,236, which is a continuation of
U.S. application Ser. No. 14/713,401, filed May 15, 2015, entitled
"Orthopedic Compression Plate and Method of Surgery," now
abandoned, which is a divisional application of U.S. patent
application Ser. No. 13/728,532, filed Dec. 27, 2012, entitled
"Orthopedic Compression Plate and Method of Surgery," now U.S. Pat.
No. 9,060,822, which is a CIP of U.S. patent application Ser. No.
13/372,902, filed Feb. 14, 2012, entitled "Orthopedic Compression
Plate," now U.S. Pat. No. 9,005,255, which claims the benefit of
priority under 35 U.S.C. .sctn. 119 of U.S. Provisional Application
Ser. No. 61/580,680, filed on Dec. 28, 2011, each of which is
incorporated by reference fully herein.
FIELD OF THE INVENTION
[0002] The present invention relates to an orthopedic plate, which
is configured to increase compression at a bone interface, in
particular to stabilize bones or bone fragments relative to each
other such as to cause fusion. Specific embodiments and methods of
fixation are presented for fixation of the bones of the foot
including, for example, stabilization of a fracture, dislocation or
reconstruction of a deformity such as use in osteotomies and
bunionectomies. The invention also applies to fusion procedures in
other areas of the body, including the wrist or hand. The plate has
a compression structure located generally peripherally to the mass
of the plate, which receives a screw that acts as an
inter-fragmentary screw while the plate augments the stabilization
and compression that is achieved by the screw. The plate is
provided with an elongated structure or body that allows the plate
to be fixed to the bone fragments while the compression is achieved
using the screw. In a further embodiment, the invention relates to
a system of plates for use in lapidus procedures and to a method of
correction of bunions using the present invention.
BACKGROUND OF THE INVENTION
[0003] The feet and the hands both include numerous bones and
joints that cooperate together to define quintessential human
movement. They are sophisticated, delicate and altogether elegant
in function and design. Together the foot and ankle have over 25
bones and 33 joints along with more than 100 named muscles,
tendons, and ligaments and a network of blood vessels, nerves, all
residing beneath a relatively slim covering of soft tissue and
skin. Structurally, the foot has three main anatomical regions: the
forefoot, the midfoot, and the hindfoot. These parts work together
with the ankle, to provide the body with support, balance, and
mobility. A structural flaw or malfunction in any one part can
result in the development of problems, which are manifested in
other areas of the body. The hand forms a cognate to the foot with
27 bones within the hand and wrist. There are eight small bones
within the wrist called the carpals, which join with the radius and
the ulna to form the wrist joint. The carpals connect with the five
metacarpals to form the palm of the hand, which terminate in the
rays (i.e., the thumb and fingers) formed by the phalanges. The
three phalanges in each finger are separated by two joints, called
interphalangeal joints (IP joints). The one closest to the MCP
joint (knuckle) is called the proximal IP joint (PIP joint). The
joint near the end of the finger is called the distal IP joint (DIP
joint). The thumb only has one IP joint between the two thumb
phalanges. The IP joints of the digits also work like hinges when
you bend and straighten your fingers and thumb.
[0004] Similarly, the forefoot includes the five toes (which are
also known as the "phalanges") and their connecting long bones (or
"metatarsals"). Several small bones together comprise a phalanx or
toe. Four of the five toes have three phalanx bones respectively
connected by two joints. The big toe (or "hallux") has two phalanx
bones distal and proximal with a joint in between called the
interphalangeal joint. The big toe articulates with the head of the
first metatarsal at the first metatarsophalangeal joint (the "MTP"
joint) and there are two tiny, round bones called sesamoids on the
plantar side of the metatarsal head. The phalanges are connected to
the metatarsals at the ball of the foot. The forefoot balances
pressure on the ball of the foot and bears a substantial amount of
the body weight. The first metatarsal forms a joint at the mid-foot
with the cuneiform. This joint is referred to as the MTG joint or
metatarsocuneiform joint. In the native position, the first
metarsal is relatively parallel to the second metatarsal. When
bunions are formed, the first metatarsal becomes displaced at an
angle relative to the second metatarsal, and often in response, the
big toe subluxates.
[0005] The bones of the midfoot from medial to lateral are the 1st
through 3rd cuneiform, the cuboid, and the crescent shaped
navicular bone posterior to the cuneiforms, which also forms a
joint with the talus that forms the basis for the ankle joint at
the hinged intersection of the tibia, the fibula, and the foot. The
five tarsal bones of the midfoot act together form a lateral arch
and a longitudinal arch, which help to absorb shock. The plantar
fascia (arch ligament) underlays the bones of the midfoot and along
with muscles, forms a connection between the forefoot and the
hindfoot. The toes and their associated midfoot bones form the
first through fifth rays beginning with the great toe as the first
ray. The bones which form the palmate portion of the hand are: the
scaphoid, the lunate, the triquetrum, the pisiform, the trapezium,
the trapezoid, the capitate, and the hamate, which act in concert
to allow the opposition of the thumb with each of the fingers and
to permit the uniquely human ability to manipulate objects.
[0006] The hindfoot is composed of three joints (subtalar,
calcaneocuboid & talonavicular) and links the midfoot to the
ankle. The heel bone (or "calcaneus") projects posteriorly to the
talus and forms a lever arm to activate the hinged action of the
foot so as to allow propulsion of the entire body from this joint.
The calcaneus is joined to the talus at the subtalar joint. The
mid-foot is often the subject of trauma, such as results from
falls, vehicle crashes and dropped objects. These accidents often
result in severe fractures and/or dislocations. In addition, there
are several conditions which result from congenital deformation or
which arise as a result of repeated use type injuries. Surgical
intervention that includes surgical sectioning of bone or an
"osteotomy" is often used to restructure the bones as a treatment
for such conditions, for example, the bunionectomy. The present
invention is likewise useful for conditions of the hand that result
from prior trauma, surgical intervention or defects from birth or
that develop with age (such as rheumatoid arthritis).
[0007] Examples of some of the other procedures with which the
present invention could be used include hallus valgus and hallus
rigidus corrections, as well as lapidus surgeries. Other
applications, which could use the present invention, include first
and fifth metatarsal chevrons, translational osteotomies, closing
wedge osteotomies, pediatric femoral osteotomies, metacarpal and
calcaneal rotational osteotomies, intrarticular osteotomies and
hand and wrist realignment osteotomies. Specific surgical
techniques are discussed for the use of an embodiment of the
invention designed for use in bunionectomies specifically involving
the MTP and MTC joints.
[0008] Typical surgical treatment of the foot or hand
re-establishes a normal anatomy while the fractured bones mend. In
some cases, fusion of a joint may be necessary, for example, where
arthritis arises in a patient due to use injuries, poor bone or
prior unsuccessful surgeries. One current surgical treatment of
these conditions requires that pins, wires and/or screws be
inserted to stabilize the bones and joints and hold them in place
until healing is complete. For example, a pin or interfragmentary
screw may be introduced medially into the internal cuneiform and
through the base of the first and/or second metatarsal bone. While
the use of k-wires, pins, and screws may provide acceptable results
for younger and more plastic patients, these methods of fixation
are not always satisfactory, in particular in cases of early
weight-bearing on the operative joint, which can result in
secondary issues such as elevated metatarsal, plastic deformation,
or lesser metatarsal overload.
[0009] The present invention combines the advantages of the prior
art screw/pin fusion methods with the advantages of a plate, and
allows the surgeon the option of using an interfragmentary or
fusion compression screw in a procedure that also incorporates a
plate and thus provides the advantages for stress shielding and
force loading or balancing that permits earlier weight bearing.
Templates are provided which facilitate the operative procedure,
including alignment holes for the positioning of guide wires which
can remain in position during placement of the plate,
counter-boring the surgical site to accommodate the compression
screw housing and placement of the "inter-fragmentary" or
compression screw. Further, the plate includes elongated wire
and/or screw holes that allow for the compression and attendant
relative bone movement during the surgery by the engagement of the
compression screw. The compression screw or screws are placed in
the plate so as to minimize the possibility of interference with
the guide wires and plate screws. The openings in the plate for the
compression screws are provided in a peripheral, and/or distal
portion of the plate, and further for some applications are
displaced from and do not lie on the long axis of the plate body,
but are offset from by means of a longitudinal curve in a extended
or tail portion of the plate which receives the screw or by
providing a peripheral tab that curves inward so as to wrap the
axis. This allows a placement of the compression screw that exerts
a force on a diagonal to the long axis of the plate (i.e. a
compound force relative to the plate). Further, in one embodiment,
a compression housing or "pocket" is provided which projects below
the bone-facing surface of the plate, which includes a slotted
opening for the compression screw. Thus, the screw can be angled
with a single degree of freedom (i.e. linearly) with respect to the
axis of the compression screw hole in the housing.
[0010] Finally, in a plate system in accordance with the present
invention, a surgical tray is provided with a series of plates that
include a varying degree of offset to accommodate the correction
for a varying degree of anatomical deformity in a lapidus
procedure. Preferably this system provides for a left and right set
of plates, each set optionally including a first plate that has a
compression slot rather than a shrouded compression housing, a
"neutral" plate having a compression housing and a 3.5.degree.
offset between the posterior and anterior end of the plate, a
4.degree. plate that has a total offset of 7.5.degree., a 8.degree.
plate that has a total offset of 11.5.degree. (all angles being
expressed at +/-0.5.degree.) and a medial column plate that is
designed to provide for additional fixation of the first ray. At a
minimum, the sets include the first plate which is considered
"neutral" (and has an offset of 2.5.degree.-4.5.degree.), the
second plate which has an additional offset of 2.degree. to
5.degree. (for a total of 4.5.degree.-9.5.degree.) and a third
plate has an additional offset of 6.degree. to 10.degree. (for a
total of 10.degree. to 20.degree.) . The system provides for at
least these three plates available during a surgery in a single
tray, and additionally the system provides for a left set and a
right set of implants, for a total of at least six plates available
to the operating surgeon. Optionally, the system may also include a
non-pocket plate that has a double tabbed end and an opposing
tri-lobed end with the intermediate lobe including a compression
slot, and the system may include a medial column plate that has a
series of threaded medial tabs for locking screws and at one end a
lobe that has a terminal compression slots to achieve compression
toward the other end of the plate, and the other end of the plate
has a middle compression slot which acts to achieve compression
towards the middle of the plate.
SUMMARY OF THE INVENTION
[0011] In accordance with the present invention an orthopedic plate
is provided that achieves improved compression through the use of a
screw that is situated with its axis obliquely to the spine of the
plate (i.e. to the longitudinal axis in the plane of the plate
taken at the opening of the compression opening of the plate). The
term "spine" of the plate is used to mean a line or curve that is
generally medial to the mass of the plate, taking into account that
the plates of the invention are somewhat more long than wide, but
are amorphous in profile, and have end sections that are may be
asymmetrically lobed or tabbed with semi-circular conjoined tabs
including screw holes that can have internal threads for locking
screws.
[0012] Preferably, the compression screw is received in a housing
or pocket which includes an opening in the top surface of the plate
and a shroud which extends from the bottom surface of the plate so
as to define a pocket on the bottom of the plate that captures the
screw at a variable orientation. The housing extends through the
plate to accommodate the entire diameter of the head of the screw
(i.e. so that the head of the screw does not project significantly
or at all beyond the top of the plate when the screw is fully
implanted within the plate). Thus, the screw head does not project
beyond the top surface of the plate when the screw is fully seated
in the housing. (By "top" it is meant herein the exterior facing
surface, which is opposite through the thickness of the plate from
the bone-facing surface, of the plate when the plate is in position
on the bone. It is understood that the orientation relative to the
ground is dependent on the orientation of the plate in space, and
therefore that is not relevant in determining what is "top" in this
case). The housing also includes an opening on the bottom of the
plate through which the screw extends and which is smaller than the
diameter of the screw head so as to capture the screw in the
housing. Also the housing is slightly larger than the bottom
opening so that the convexly rounded screw head has some play in
the pocket to allow some freedom of angulation (i.e. about 5 to
about 30.degree., preferably about 10 to about 20.degree.) of
conical or modified conical rotational freedom of the screw
relative to the housing axis (as measured from the groove formed
through the compression opening.) In a further embodiment, the
opening is elongated or is a slot, which allows the screw to be
placed at a linear variable angle (that is a restricted portion of
the conical angulation) relative to the housing, where the amount
of angulation is about +/-120, preferably +/-10.degree., and more
preferably +/-6.degree. of linear freedom relative to the axis of
the housing. The angle of the axis of the oblique screw is from
about 10.degree. to about 70.degree., more specifically about
25.degree. to about 60.degree. and most specifically about
35.degree. to about 55.degree. degrees to a longitudinal axis of
the plate which dissects the compression opening on the plate (i.e.
the "spine of the plate"). A compressive force is applied to the
bone or bone fragments by the plate as the oblique screw is screwed
tighter and the screw head compresses into an increased fit with
the pocket, and in particular with the pocket bottom opening. This
draws that bone segment into which the compression screw is
screwed, toward the locking screw or screw in the other end of the
plate and accordingly into compression with the bone segment into
which the screws associated with the other end of the plate, are
screwed.
[0013] In a first embodiment, of the plate, an application specific
configuration is illustrated as a MTP plate, which is intended to
span the MTP joint. In a first version of the MTP plate of the
present invention, the plate outline has (again "consists
essentially of") a first end with two lateral tabs on either side
of a middle tab, and a second end with two lateral tabs and no
intermediate tab. Each of these tabs is provided with a threaded
screw hole that receives a threaded locking screw. The end with the
two tabs, also includes a compression housing as previously
described that accepts a screw which extends toward the first end
of the plate with its axis at an oblique angle of about 5.degree.
to about 40.degree., more preferably about 10.degree. to about
30.degree., and most preferably about 15.degree. to about
25.degree. with respect to the longitudinal axis of the plate.
Further, the plate has an angle of up to about 10.degree. (and
preferably about 5.degree.) for dorsiflexion and an angle up to
about 10.degree. for valgus. The bottom surface of the plate is
radiused. This allows the plate to be in snug contact with the
bone. This plate is also provided in a second version which differs
from the first in that the second end does include three tabs
similar to the first end, an the compression housing is located at
at an oblique angle of about 5.degree. to about 40.degree., more
preferably about 10.degree. to about 30.degree., and most
preferably about 15.degree. to about 25.degree. to the lateral side
of the plate and intermediate along the longitudinal axis to the
tabs, and further houses a screw hole that defines an axis at an
angle of about 55.degree., about 15.degree., preferably about
10.degree., and most preferably about 5.degree. to a line
perpendicular to the plate surface at a point along the plate
longitudinal axis. The compression housing is similar in concept to
the previously described compression housing, but in this case, has
a round footprint describing at least a portion of a circle, and
preferably is substantially a portion of a circle, with a leading
edge that is linear. Once again, the housing has an internal recess
that houses the compression screw and which has a narrowed opening,
that is smaller than an associated screw head so as to capture and
retain the screw, but which allow for conical rotation in the
compression housing.
[0014] A third embodiment of the plate is intended for use in
lapidus procedures which are also used to correct bunions, but by
realigning the metatarsal relative to the rear joint with the
cuneiform. Lapidus procedures in accordance with the present
invention have several advantages over past procedures, including
earlier post operative weight bearing, inhibition of elastic
deformation, preservation of the function of the MTP joint,
realignment of the big toe, better outcomes in the event of
mal-union or non-union, and better rear-foot alignment.
[0015] In the plate system in accordance with this embodiment, the
plate has an even more complex footprint with the posterior end
(i.e. toward the heel end of the plate) of the plate including a
double tabbed end with each tab including a threaded locking screw
hole, and where the inferior tab proceeds (i.e, is rearwards of)
the superior tab in the posterior direction. The anterior end of
the plate includes a tri-lobed outline in which the central lobe
and the superior lobe or tab include internally threaded locking
screw holes, and the third lobe or tab which is less distinct than
the other two lobes and is curved inward and downward toward the
bone-facing surface. This lobe includes a shroud, housing or pocket
which projects below the plate as the previously described screw
housings, and which receives a screw that projects posteriorly and
dorsally to apply compression across the MTC (metatarsocuneiform)
joint. This embodiment of the invention differs from the first
embodiment in that the compression screw housing is provided in a
location that does not lie on the longitudinal axis, and more
preferably is located in a peripheral (both longitudinally and
medially) portion of the plate which accepts a screw so as to pull
a compressive force diagonally across the body of the plate in
opposition to the plate screws that hole the plate in position
relative to the bone segments. Thus, the screw applies a compound
force (i.e. having force components in the direction of the
longitudinal axis and transverse to it) so that this plate presents
the advantages of the prior art interfragmentary screws which tend
to be placed in this position, combined with the additional
stability and weight bearing ability of a plate which wraps the
bone and creates a construct with the bone that is aligned to
stabilize with the bone axes.
[0016] The invention also relates to a novel surgical procedure,
which is a bunionectomy that involves the use of the bunionectomy
plate of the present invention, as well as to a lapidus procedure
which utilizes the plate in accordance with the invention where a
template is placed along with guide wires, the bone is reamed to
receive the compression screw pocket, the template is slid off the
guide wires and the plate is slid on, all the time maintaining the
established alignment of the bones with the guide wires. The distal
plate screws are place in the anterior end of the plate, a guide
wire is placed through the joint, and a cannulated screw is placed
in the compression pocket across the joint. Since the plate is
provided with slot or slots in opposition to the compression
pocket, and the template is provided with guide wire holes spaced
appropriately to account for the compression achieved with the
screw, the guide wires move in the slots in the plate to account
for the compression achieved by the compression screw. The guide
wires can be removed, the posterior screws are implanted, and the
wound can be closed. The plate and template system allow the
security of the guide wire used for the interfragmentary
compression, and the screws allow for multiplanar fixation, while
inhibiting the possibility of screw interference. Alternatively to
the guide wire slots, the plate can include slotted screw holes and
the plate can be attached to bone using these slotted holes prior
to the tightening of the compression screw where the screws slide
in the slot to account for a change in the relative position in the
plate as compression is achieved across the joint or between the
bone fragments.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] FIG. 1 is a top perspective view of a first embodiment of
the orthopedic compression plate in accordance with the present
invention;
[0018] FIG. 2 is a top view of the orthopedic plate of FIG. 1;
[0019] FIG. 3 is a bottom view of the orthopedic plate of FIG.
1;
[0020] FIG. 4 is a side and bottom perspective view of the plate of
FIG. 1,
[0021] FIG. 5 is a first side view of the plate shown in FIG.
1;
[0022] FIG. 6 is a first cross-sectional view of the plate shown in
FIG. 2, taken along line 6-6;
[0023] FIG. 7 is a side view taken from the other side of the plate
shown in FIG. 1;
[0024] FIG. 8 is a second cross-sectional view of the plate shown
in FIG. 2, taken along line 6-6 and looking in the opposite
direction from FIG. 6;
[0025] FIG. 9 is a left end view of the plate shown in FIG. 1;
[0026] FIG. 10 is a right end view of the plate shown in FIG.
1;
[0027] FIG. 11 is a top view of a second version of the embodiment
of the plate shown in FIG. 1;
[0028] FIG. 12 is a first side view of the plate shown in FIG.
11;
[0029] FIG. 13 is a cross-section of the plate shown in FIG. 11
taken along line 13-13;
[0030] FIG. 14 is a bottom view of the plate shown in FIG. 11;
[0031] FIG. 15 is a cross-section of the plate shown in FIG. 11
taken at line 15-15;
[0032] FIG. 16 is a top view of a left version of the embodiment of
the plate shown in FIG. 11;
[0033] FIG. 17 is a detail in cross section of the plate shown in
FIG. 11;
[0034] FIG. 18 is a top view of a third embodiment of the
orthopedic compression plate in accordance with the present
invention;
[0035] FIG. 19 is a first side view of the orthopedic plate of FIG.
18;
[0036] FIG. 20 is a bottom view of the orthopedic plate of FIG.
18;
[0037] FIG. 21 is a first end view of the plate of FIG. 18;
[0038] FIG. 22 is a second end view of the plate shown in FIG.
18;
[0039] FIG. 23 is an end and bottom view of the plate of FIG. 18
which illustrates the compression screw opening;
[0040] FIG. 24 is a bottom view of the orthopedic plate of FIG. 18
including associated screws to form a plate assembly;
[0041] FIG. 25 is a first side view of the orthopedic plate
assembly of FIG. 24;
[0042] FIG. 26 is a top view of the orthopedic plate assembly of
FIG. 24;
[0043] FIG. 27 is a first end view of the plate assembly of FIG.
24;
[0044] FIG. 28 is a second end view of the plate assembly shown in
FIG. 24;
[0045] FIG. 29 is a view showing top and side views of a left and a
right set of plates in accordance with a further embodiment of the
invention;
[0046] FIG. 30 is a side view of a non-locking screw that can be
used with the invention;
[0047] FIG. 31 is a side view of a locking screw that can be used
with the invention;
[0048] FIG. 32 is a side view of a variable locking assembly that
can be used with the invention;
[0049] FIG. 33(a)-33(l) illustrates a method of performing a
surgery using the plates and instruments in accordance with the
invention; and
[0050] FIG. 34 is an alternative embodiment of the MTC plate of
FIG. 18.
DETAILED DESCRIPTION OF THE INVENTION
[0051] FIGS. 1-10 show a first version of plate for use in the MTP
joint, the junction of the head of the first metatarsal and the
proximal phalange of the first ray (i.e. the great toe) at the
first metatarsophalangeal joint. The plate used in fixation (i.e.
for fusion) of the bones of the first MTP joint, and is thus termed
an MTP plate. The plate 110 has a first end 112 which is tri-lobed,
or has three rounds tabs 113, of just appropriate size to form
mounting rings for threaded locking holes 114 which receive the
locking screws having an externally threaded locking head. The tabs
include a rounded portion for example large enough to accommodate
an opening for a screw hole, and contiguous material that holds the
rounded projection to the general plate body. The tabs are
longitudinally offset from each other, and angled inward toward the
medial axis of the plate to improve the purchase in the plate, and
inhibit backout. The other end 118 of the plate 110 includes two
laterally and longitudinally offset tabs 115 which are also just of
appropriate size to form mounting rings for threaded locking holes
114 which receive threaded locking screws 130. The second end 118
of the plate includes a compression housing similar 116.
[0052] The compression housing 116 includes an opening 120 in the
top surface 122 of the plate. The opening 120 is ovoid, with a
width that wide enough to accept the compression screw 132 that is
received in the opening 120. The compression screw is of slightly
greater diameter and of greater length than the locking screws. The
opening 120 angles into the top surface 122 of the plate 110 so as
to form a groove 124 that accommodates and guides the screw 132 and
a mating driver as the screw is screwed into the bone below the
plate. On the bottom surface 123 of the plate 110 there is a shroud
126, which has a rectangular flat rear surface 127 joined to flat
side walls 128. The term "shroud" as used herein means that the
housing creates a "pocket" of enclosed space for the compression
screw head, which is closed to the bone surface and in which the
structure that defines the enclosed space is connected at each side
to the bottom of the plate. This reinforces the housing structure,
helps to create additional compression and closes the housing from
the possibility of tissue interference or in-growth. The "housing"
comprises a more complete structure than a flat solid rib which
projects from the bottom surface of the plate and includes a screw
hole (threaded or not). The shroud 126 includes a lower opening 129
which is circular, and which is large enough to allow the major
diameter of the screw to pass through, but which is smaller than
the diameter of the rounded portion 134 of the head of the screw
132. The compression housing 126 accepts a screw 132 which extends
toward the first end 112 of the plate with its axis at an oblique
angle of about 5.degree. to about 40.degree., more preferably about
10.degree. to about 30.degree., and most preferably about
15.degree. to about 25.degree. with respect to the longitudinal
spine of the plate. Further, the plate has an angle of up to about
10.degree. (and preferably about 5.degree.) for dorsiflexion and an
angle up to about 10.degree. for valgus. The bottom surface of the
plate is radiused at a constant curve.
[0053] FIGS. 11-17 illustrate a second embodiment, i.e. the MPT
plate 310, of the present invention. In this version both the first
and the second ends 312,318 includes three tabs 313,315 and locking
holes 314 within each tab. The plate 310 continues to have the same
angles for dorsiflexion and for valgus. In the first end, in which
an axis can be defined along the medial axis of the plate to the
mid-line, and dividing the terminal most screw hole in half, the
second tab hole forms an angle of about 25.degree. to the long axis
and the screw hole has an angle of about 21.degree.+/-8.degree.,
preferably +/- about 5.degree., and most preferably about 2.degree.
to the screw axis of the terminal most hole, while the screw hole
in the third tab has an angle of about 18.degree.+/-8.degree.,
preferably +/- about 5.degree., and most preferably about 2.degree.
to the screw axis of the terminal most hole, with a preferred
difference of about 3.degree.. The geometry of the opposite end of
the plate mirrors the first end, with the exception that the second
end further includes a tab 317 for a compression shroud 316 which
extends from the bottom surface of the plate and intermediate to
the second tab and has a screw housing that extends from the bottom
of the plate at an angle of about 55.degree.+/- about 10.degree.,
preferably about 8.degree., and most preferably about 5.degree.
relative to the screw hole axis of the terminal most screw hole.
The housing has a cylindrical configuration, which intersects the
plate at a linear edge. The housing has a narrowed opening that
acts to capture a screw housed in the housing but which allows
conical rotation in the housing. The inside wall of the housing
narrows at an angle of 40.degree. relative to the axis of the
housing. The housing 316 has a narrowed opening that acts to
capture a screw housed in the housing but which allows conical
rotation in the housing. The inside wall of the housing narrows at
an angle of 40.degree. relative to the axis of the housing. On the
bottom surface 323 of the plate 310 there is a shroud 316, which
has a rear surface 327 joined to side walls 328. The shroud 316
includes a lower opening 329 which is circular, and which is large
enough to allow the major diameter of the screw to pass through,
but which is smaller than the diameter of the rounded portion 234
of the head of the screw 232. FIG. 16 shows right plate MPT plate
410 which is a mirror image of the left MPT plate shown in FIG. 10.
Once again, both the first and the second ends 412,418 includes
three tabs and locking holes 414 within each tab and the second end
also includes a tab 417 for a compression shroud 416 which extends
from the bottom surface of the plate. The plate continues to have
the same angles for dorsiflexion and for valgus. The geometry of
the opposite end of the plate mirrors the first end, with the
exception that the second end further includes a fourth tab
intermediate to the second tab and has a screw housing that extends
from the bottom of the plate at an angle of about 55.degree.+/-
about 10.degree., preferably about 8.degree., and most preferably
about 5.degree. relative to the screw hole axis of the terminal
most screw hole. The housing has a cylindrical configuration, which
intersects the plate at a linear edge.
[0054] FIGS. 18-28 illustrate a third embodiment of the invention
which is a lapidus plate and assembly designed for use in lapidus
procedures. This plate 510 has a first end 512 and a second end
518, where the first end includes two tabs 515, each having
internally threaded locking screw holes 514. A second end 518 has
three conjoined tabs or lobes 515 two of which include internally
threaded locking screw holes 514. The third lobe includes a
compression housing 516 that projects into the plate so as to
provide a seat for a compression screw and a structure that will
also contribute to this compression in the bone. Once again, this
compression housing is a peripheral compression housing that is not
located on the spine or longitudinal axis of the plate, and the
screw located in this housing does not act to apply a force
substantially solely in the direction of the longitudinal axis or
along the spine of the plate, but rather acts so as to apply a
compound force that is directed in a diagonal direction across the
body of the plate. The opening of the housing is elongated or
slotted in the direction transverse to the axis of the slot so as
to define linear angulation in the slot hole for the compression
screw.
[0055] The plate also includes at least one slot 520 having a long
axis, which is aligned with the direction of compression imposed by
the compression screw. The slot receives a guide wire and allows it
to remain in place stabilizing the bone fragments as the
compression screw is tightened and a first bone segment is
compressed against a second bone fragment. Optionally, the plate
may include an additional guide wire hole 524 located in the
vicinity of the compression housing. It is noted that the guide
wire holes are smaller than the screw holes, and have a diameter
that is slightly (i.e. between about 3 and 10% larger in diameter
than, and preferably greater than about 3 and 7% larger than the
diameter of a guide wire where the slotted version is from 1.5 to 3
times the diameter in length.) Alternatively as shown in FIG. 34,
the slotted guide wire hole could be a slotted screw hole or
compression hole 521 with a similar ratio of length to width (i.e.
providing for a length that corresponds to the amount of
compression that is achieved and is about 1-5 millimeters.) FIGS.
24-28 illustrate the plate 510 including plate screws 526 and
compression screw 528. These views illustrate how the invention
provides for the compression screw with a minimized concern for
interference with the plate screws. Figure 30 illustrates a
threaded locking screw 600, that can be used with the invention,
while FIG. 31 illustrates a compression screw 610, and FIG. 32
illustrates a variable locking screw assembly 620 that can be used
with the present invention.
[0056] The lapidus plate also includes mid-section 530 located
intermediate the first and second ends and which can provide for an
offset of varying degrees. Thus, in the plate system shown in FIG.
29, the plates are shown with a varying degree of offset provided
in the mid-section. A medial column plate 511 is also provided
which includes two opposing compression slots that act in
opposition to each other, and which are provided in the distal and
proximal ends of the plate. The system includes left and right
versions of a non-pocketed plate 509; a neutral plate 510; a
4.degree. correction plate 510(a); a 8.degree. correction plate 510
(b) and the medial column plate 511.
[0057] In one method of causing locking of the screw relative to
the plate, the screw 600 could include external screw threads 602
that mate with internal threads in the locking screw hole at a
pre-selected angle, in some instances, the screw axis is
perpendicular to a tangent at the top of the screw hole so that the
screw axis angles slightly toward the bottom of the plate. However,
other methods of causing locking could be employed, such as a
variable locking assembly 622. The screw 610 used in the
compression housing has a rounded rear shoulder 612 (such as a
hemisphere, or a torroid), which allows for play in the convexly
rounded recess in the compression housing. The compression is
caused when the compression screw engages the bone and pulls the
plate into that bone as it engages a downwardly sloping shoulder on
the compression slot, and the locking screw or screws act on their
respective bone segment.
[0058] The screws shown in FIGS. 30-32 which are useful with the
plate of the present invention are self-starting, self-tapping
screws including the option of partial or full cannulation. The
screws include a cutting end having multiple flutes, and preferably
2 or 3 flutes about a conical recess, and preferably have a rounded
end to avoid soft tissue irritation should they break an opposing
cortical surface. The screws further include a partial taper of the
inner diameter in the proximal end over the first several thread
turns, for example over 2-8, and preferably over 3-5 turns in order
to increase the fatigue life of the screw as well as providing
potential physiological advantages in use. The screws further
include a torque driving recess.
[0059] The plate is formed of a biocompatible material, and
preferably a metal such as surgical grade stainless steel, titanium
or a titanium alloy. Preferably, the plate has a thickness of
between about 1.0 and 2.0 millimeters, more preferably between
about 1.2 and 1.5 millimeters, and most preferably between about
1.25 and 1.40 millimeters. The compression housing extends a depth
below the bottom surface of the plate from about 1.4 to about 3 mm,
preferably from about 1.75 to about 2.25 mm, and has a width of
from about 3.5 to about 5.5, preferably from about 4 to about 5 mm,
and a length of from about 3.0 to about 8.0, mm preferably from
about 5.0 to about 7.0 mm. The opening in the upper surface of the
plate for the compression opening is from about 8 to about 15 mm in
width, and from about 10 to about 18 mm in length. The lower
opening is about 2.5 to about 2.9 mm in diameter with a recess
width of from about 2.5 to about 4.5 mm. The locking screw holes
include a flat annular recess surrounding the threaded area that is
about 0.4 to about 0.6 mm in width. The universal plate (i.e. the
tab-like plate) has a length of from about 35 to about 45 mm,
preferably from about 38 to about 42 mm, and the compression screw
axis forms an angle of from about 30.degree. to about 40.degree. to
a longitudinal axis on the top of the plate. The MTP plate has a
length of from about 40 to about 50 mm in length. The compression
screw axis forms an angle of about 22.degree. to about 37.degree.
with a longitudinal axis tangent to the bottom of the plate at the
housing exit. In the bunionectomy plate, the chamfer at the bone
insertion end is from about 5.degree. to about 15.degree.,
preferably from about 8.degree. to about 12.degree., and the length
of the chamfer is from about 2 to about 4 mm, preferably from about
2.5 to about 3.5 mm and the plate has a total length of from about
175 to about 225 mm, preferably from about 185 to about 200 mm,
with the taper. The axis of the compression screw forms an angle of
from about 35.degree. to about 45.degree. to a longitudinal axis on
the bottom of the plate. The plate includes a continuous outer
edge, which is defined between the top and the bottom surface. In
addition, the plate can include a small through hole sized to
receive a K-wire or other similar guide wire.
[0060] During the surgery the joints are first prepped which may
include de-articulation between the bones to be fused. The bones
are reduced, the plate is located such that all of the screws are
aimed into the targeted bones and away from the joint, and the
locking screw(s) is inserted into a pre-drilled pilot hole or
holes. A pilot hole is drilled for the compression screw, and the
compression screw is tightened into position. The two locking
screws are screwed into adjacent cuneiforms. The plate is viewed
radiographically. The incision is closed per the usual method.
[0061] The following is a description of a surgical technique for
an MTP fusion using the MTP fusion plate in accordance with the
present invention. First, prepare the MTP joint for fusion and
choose the desired plate from the surgical tray. Note, that the
plates are pre-contoured to provide 10.degree. of valgus and
5.degree. of dorsiflexion and can be used on either foot. The
plates should be placed so that the plate's pocket is on the medial
side of the foot. For instance, using the Alpha.TM. plate on the
right foot the pocket is on the proximal side of the joint. When
used on the left foot, the pocket of the Alpha.TM. plate is on the
distal side of the joint. If necessary, use the bending pliers to
contour the plate to the bone surface. Using a k-wire, placed in
the plantar portion of the bones from medial to lateral across the
joint, temporarily fix the joint in the desired position. Assemble
the template that corresponds to the chosen plate with the
countersink guide by snapping the template into the guide. Lay the
template on the bone and orient to the desired position of the
plate. Place two 0.9 mm k-wires. Prepare for the plate pocket and
inter-fragmentary screw with the provided countersink through the
template assembly. Insert the countersink until the shoulder of the
countersink hits the guide normal to the plate in the k-wire holes.
With the k-wires still in place, slide the template off the bone
and using the wires to help placement, slide the chosen plate over
the k-wires so that the plate's pocket fits within the prepared
hole. Select one of a fixed locking, non-locking or variable angle
locking screw to be used in one of the threaded locking holes that
is on the same side of the joint, proximally or distally, as the
pocket and chose the appropriate drill bit based on the screw
selection. Using a color-coded drill guide, drill to the desired
depth, determine the screw length using the depth gages, and insert
a selected screw into the hole and drive the screw for each screw
hole. Using the 1.4 mm guide wire tip, insert a 1.4 mm guide wire
in to the pocket hole across the MTP joint and ensure that the
guide tip is seated within the pocket before inserting the wire.
Use the cannulated drill bit to drill for the inter-fragmentary
pocket screw over the guide wire. Determine the required screw
length over the guide wire using the depth gage and insert the
inter-fragmentary screw in the pocket of the plate using the
corresponding driver. Before the pocket screw is completely seated,
remove the k-wire used for temporary fixation and fully tighten the
pocket screw. Fill all remaining screw holes and completely tighten
all remaining screws. Verify the correct placement of the plate and
screws, replace soft tissue and close the opening.
[0062] The present invention offers a site-specific design for
fixation and fusions involving the first metatarsocuneiform (MTC)
joint. The system includes several plates for varying degrees of
deformity correction, from neutral (no correction) to 8.degree.
past neutral. All plates feature an anatomically contoured design
to fit the medial aspect of the joint. The implant design allows
the plate to fit the flatter cuneiform and curved first metatarsal,
creating a low-profile construct and reducing the need for
intra-operative plate bending. The present invention allows
insertion of a targeted 4.0 mm inter-fragmentary screw through the
plate, designed to maximize compression and reduce the risk of
hardware collision associated with supplementary cross-screw
insertion outside of a plate. The system further allows the plates
to accommodate all of non-locking, fixed-angle locking and
variable-angle locking screws for fixation without compromise. The
compression screw can be a partially threaded or fully threaded
cannulated or solid screw. All of these can be provided in the
surgical tray or caddy and thus are made available at the time of
surgery.
[0063] The steps of the surgery are detailed below:
[0064] Step 1: Perform standard exposure and prepare the
metatarsocuneiform (MTC) joint according to surgeon preferred
technique for a medial approach.
[0065] Step 2: Temporarily fix the joint in the desired orientation
using the provided k-wires. Recommended wire placement is through
the dorsal aspect of the joint, directed into the plantar-lateral
aspect of the cuneiform and into the intermediate cuneiform or
second metatarsal if desired. FIG. 33(a).
[0066] Step 3: Select the plate template. The plate and templates
are side specific and designed so that the pocket is on the
plantar-medial aspect of the joint and a template is provided at
each offset corresponding to the appropriate degree of correction:
i.e. neutral (0.degree. of correction), 4.degree. past neutral, and
8.degree. past neutral. Note that the neutral template has a slight
bend to fit the natural angle of the joint. The 4.degree. and
8.degree. designations reflect the amount of bend past neutral and
do not necessarily correspond to the total IM correction angle.
[0067] Step 4: Insert a 1.4 mm k-wire through each k-wire hole in
the template. The templates include raised nubs which surround the
guide wire holes in order to provide for parallel placement of the
guides wires relative to each other, and an alignment that is
desired relative to the foot. Take care to keep the wires parallel
during insertion as they will later facilitate plate placement.
FIG. 33(b).
[0068] Step 5: Select the provided countersink and drill through
the template to prepare a pocket for the plate. FIG. 33 (c). Ensure
that the template is held tightly against the bone during this step
in order to fully prepare the pocket. Insert the countersink until
the shoulder of the countersink hits the guide. FIG. 33(d).
[0069] Step 6: With the k-wires still in place, slide the template
off the bone. Then slide the corresponding plate over the wires and
position into the prepared pocket. FIG. 33(e). The proximal k-wire
should pass through the k-wire slot in the plate.
[0070] Step 7: Using the fixed drill guide and the 2.4 mm drill
bit, drill a pilot hole for the most distal screw. FIG. 33(f). Take
care to not move the plate after drilling for a locking screw in
order to maintain the proper pilot hole alignment and prevent
locking screw cross-threading. The threaded screw holes in the
plate are compatible with a variety of screw options; 3.5 mm
non-locking or fixed-angle locking screws (magenta) and 4.0 mm
non-locking screws (teal) are included in the Set. Depending on
surgeon preference, a combination of screw types can be used.
[0071] Step 8: Determine the screw length required using the
provided depth gage.
[0072] Step 9: Remove the desired screw from the screw caddy using
the provided driver. For all screws used throughout the procedure,
verify the screw length using the gauge provided on the screw
caddy.
[0073] Step 10: With the driver, insert the selected screw into the
hole and drive the screw.
[0074] Step 11: Follow the same technique for the remaining distal
screw hole.
[0075] Step 12: Select the 1.4 mm pocket wire guide and place the
nose into the plate pocket, aligning the solid line on the guide
with the dashed line on the plate.
[0076] Step 13: With the guide fully seated in the plate pocket,
insert a 1.4 mm guide wire through the guide at the desired
trajectory. FIG. 33(g). The recess within the pocket wire guide is
slotted to allow for 12.degree. of planar angulation within the
slot of the compression housing. Verify wire placement with
fluoroscopy to ensure trajectory and screw purchase will be
adequate.
[0077] Step 14: Remove the pocket wire guide and use the provided
pocket depth gauge to measure over the wire and determine the
required screw length. Keep in mind that a shorter screw may be
required based on compression generation. FIG. 33(h).
[0078] Step 15: Use the cannulated drill bit to drill over the wire
for the 4.0 mm pocket screw.
[0079] Step 16: Remove the 1.4 mm guide wire from the pocket in
order to insert a partially threaded solid screw. Leave any other
provisional fixation in place to maintain proper alignment. FIG.
33(i). If a cannulated screw is used the pocket guide wire may be
left in place during initial screw insertion to further maintain
joint alignment.
[0080] Step 17: Using the driver, insert the appropriate length
partially threaded screw through the pocket until almost fully
seated in the pocket. FIG. 330).
[0081] Step 18: Remove any provisional fixation wires and fully
tighten the pocket screw. The proximal k-wire may remain in place
during screw insertion to maintain plate alignment; the slot will
allow plate translation during pocket screw insertion.
[0082] Step 19: Remove all remaining wires. Drill and insert the
proximal screws using the technique described in Steps 8-10 above.
Fully tighten all screws. FIG. 33(k). Verify final plate and screw
placement with fluoroscopy to ensure correct joint. FIG. 33(1).
[0083] While in accordance with the patent statutes the best mode
and preferred embodiment have been set forth, the scope of the
invention is not limited thereto, but rather by the scope of the
attached claims.
* * * * *