U.S. patent application number 11/289750 was filed with the patent office on 2006-08-31 for sternum closure device having locking member.
Invention is credited to Leonard Stevens.
Application Number | 20060195101 11/289750 |
Document ID | / |
Family ID | 26669764 |
Filed Date | 2006-08-31 |
United States Patent
Application |
20060195101 |
Kind Code |
A1 |
Stevens; Leonard |
August 31, 2006 |
Sternum closure device having locking member
Abstract
A sternal closure device including impermanently joined sliding
and receiving attachment structures which are adapted for
intercostal positioning between at least two corresponding rib
pairs and substantially surrounding a patient's sternum with each
structure having a cross member, a plurality of integrated legs and
foot members, a plurality of sternum engagement surfaces, and an
end portion. The receiving structure further incorporates a
generally bow-shaped locking member with angularly disposed
teeth-like structures positioned to receive and position a
plurality of receiving structure projection members when inserted
therein. The locking member further serves as a stabilizing
structure with stabilization facilitated via an easily removed
single screw like structure markedly facilitates quick release. The
projection members further embody complimenting positioned
teeth-like structures providing for racheting, unidirectional entry
and positioning within the receiving attachment structure.
Inventors: |
Stevens; Leonard; (Tulsa,
OK) |
Correspondence
Address: |
Andre M. Szuwalski;JENKENS & GILCHRIST, A PROFESSIONAL CORPORATION
Suite 3700
1445 Ross Avenue
Dallas
TX
75202
US
|
Family ID: |
26669764 |
Appl. No.: |
11/289750 |
Filed: |
November 29, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10699208 |
Oct 31, 2003 |
6969398 |
|
|
11289750 |
Nov 29, 2005 |
|
|
|
Current U.S.
Class: |
606/70 |
Current CPC
Class: |
A61B 17/8009 20130101;
Y10T 24/44615 20150115; A61B 17/8004 20130101; A61B 17/823
20130101; Y10T 24/44607 20150115; Y10T 24/44624 20150115; A61B
17/8076 20130101; A61B 2017/8655 20130101 |
Class at
Publication: |
606/070 |
International
Class: |
A61F 2/30 20060101
A61F002/30 |
Claims
1. A sternum closure device for positioning between at least two
corresponding rib pairs substantially surrounding a patients
sternum, the sternum closure device comprising: a sliding
attachment structure including: a plurality of projection members
with angularly disposed teeth-like structures inwardly positioned
on the innermost edges of each the plurality of projection members;
and first and second leg portions, each of the first and second leg
portions including a sliding attachment structure associated
integrated foot portion and a sliding attachment structure
associated sternum engagement portion; a receiving attachment
structure including: a securing aperture; and third and forth leg
portions, each of the third and fourth leg portions including a
receiving attachment structure associated integrated foot portion
and a receiving attachment structure associated sternum engagement
portion; and a generally bow-shaped locking member attached to the
securing aperture of the receiving attachment structure and
including a first distal end and a second distal end, each of the
first distal end and the second distal end including angularly
disposed teeth-like structures; and wherein the generally
bow-shaped locking member is resiliently tensioned between the
plurality of projection members such that the angularly disposed
teeth-like structures of the generally bow-shaped locking member
engage the angularly disposed teeth-like structures of the
plurality of projection members.
2. The sternum closure device of claim 1, wherein the receiving
attachment structure further includes securing means to removable
attach the generally bow-shaped locking member to the receiving
attachment structure.
3. The sternum closure device of claim 1, wherein the sliding
attachment structure further includes a cross member connecting the
plurality of projection members with the first and second leg
portions.
4. The sternum closure device of claim 3, wherein the cross member
includes a cut line to facilitate the separation of the plurality
of projection members from the first and second leg portions by a
cutting action.
5. The sternum closure device of claim 3, wherein the cross member
includes at least one cut hole to facilitate the separation of the
plurality of projection members from the first and second leg
portions by a cutting action.
6. The sternum closure device of claim 1, wherein at least one of
the plurality of projection members is in offset alignment by a
predetermined offset with a corresponding first or second leg
portion of the sliding attachment structure.
7. The sternum closure device of claim 1, wherein the generally
bow-shaped locking member further includes first and second
extensions extending from the first and second distal ends,
respectively, the first and second extensions to facilitate,
wherein squeezing of the first and second extensions facilitates
disengagement of the teeth-like structures of the locking member
from the teeth-like structures of the plurality of projection
members.
8. The sternum closure device of claim 1, wherein at least a
portion of a surface of the sliding attachment structure associated
sternum engagement portion is knurled.
9. The sternum closure device of claim 1, wherein the plurality of
projection members includes at least one trim hole to facilitate
trimming of the plurality of projection members to a desired
length.
10. The sternum closure device of claim 1, wherein the sliding
attachment structure and the receiving attachment structure are
sized and dimensioned to engage opposite sides of a patient's
severed sternum and facilitate the tilting of divided sternal
plates while positioned intercostally between at least two
corresponding rib pairs.
11. The sternal closure device of claim 1 wherein each of the
plurality of projection members are angularly offset with respect
to each other.
12. The sternal closure device of claim 1, wherein the generally
bow-shaped locking member may be compressed to facilitate
disengagement of the sternal closure device when previously secured
intercostally between at least two corresponding positioned rib
pairs.
13. The sternal closure device of claim 1, wherein at least one
portion of the sliding attachment structure is scored to facilitate
disengagement of the sternal closure device when previously secured
intercostally between at least two corresponding positioned rib
pairs.
14. The sternal closure device of claim 1, wherein the receiving
attachment structure further comprises at least one receiving
chamber for slidably receiving the plurality of projection members
of the sliding attachment structure.
15. The sternal closure device of claim 14, wherein the generally
bow-shaped locking member includes a locking member securing
aperture substantially centered between the first and second distal
ends to facilitate securing of the generally bow-shaped locking
member to the at least one receiving chamber of the receiving
attachment structure.
16. The sternal closure device of claim 1, wherein each of the
sliding attachment structure and the receiving attachment structure
include a clamp guide to facilitate clamping together of the
sliding attachment structure and the receiving attachment
structure.
Description
REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of U.S. patent
application Ser. No. 10/699,208 filed Oct. 31, 2003.
TECHNICAL FIELD OF THE INVENTION
[0002] This invention relates generally to surgical devices. More
specifically, the present invention relates to improved sternum
clamping devices and methods to reapproximate a patient's sternum
following a partial median sternotomy.
BACKGROUND OF THE INVENTION
[0003] A partial or median sternotomy is a procedure by which a saw
or other appropriate cutting instrument is used to make a midline,
longitudinal incision along a portion or the entire axial length of
the patient's sternum, allowing two opposing sternal halves to be
separated laterally. A large opening into the thoracic cavity is
thus created, through which a surgeon may directly visualize and
operate upon the heart and other thoracic organs or tissues.
Following such a procedure, the two severed sternal halves must be
reapproximated.
[0004] Traditionally, sternal halves have been reapproximated with
stainless steel wires wrapped around or through the sternal halves
so as to exert medial compression thereon and twisted together to
approximate the sternum. Other methods of sternum repair include
the use of band or strap assemblies which typically include a
locking mechanism, which secures a strap in a closed looped
configuration about the sternum positions. While utilization of
steel wires and strap assemblies have been widely accepted for
sternum repair, these devices present a number of disadvantages.
Steel wires can and do break, and provide insufficient
(non-uniform) clamping force resulting in sternal nonunion. Steel
wires are difficult to maneuver and place around the sternum. The
cut ends of the steel wires are also sharp and can pierce through
the surgeon's gloves or fingers. In addition, the small diameter of
the steel wires can cause the wires to migrate into or through the
tissue surrounding the sternum region or into the sternal bone
itself over time and result in sternal disintegration into small
segments. This can lead to significant patient pain and discomfort
in addition to slowing the postoperative recovery and increasing
the risk of sternal infection. Moreover, the strap mechanisms of
band assemblies are often relatively structurally complex and are
difficult to precisely apply about the sternum. There are also
healing problems associated with the use of steel wires and band
assemblies due to improper forces exerted by these devices which
can cause unwanted bone movements leading to raking and rubbing of
surrounding tissue or bone.
[0005] Several other techniques of sternal reapproximation have
been proposed both for primary closure following a median
sternotomy and for reclosure following post-operative emergency
surgical procedures. One such sternal fixation device is described
in U.S. Pat. No. 6,051,007 entitled External Closure Device and
Instruments Therefor, the entire contents of which are incorporated
herein by reference.
[0006] The sternum closure device of U.S. Pat. No. 6,051,007
however is absent some of the advantages of the present invention.
Most particularly foot portions (20, 40) of the '007 device are
limited to two points of contact on the posterior section of a
patient's sternum and consequently lack the stability and
positioning enhancement features of various embodiments of the
present invention. Quite distinguishable, from the '007 patent and
other devices practiced in the contemporary art is the novel
structure of various embodiments of the present invention which
advances the art by allowing and encouraging divided sternal plates
to be tilted upward to maximize healing surfaces in apposition to
each other, thus avoiding downward plate deflection and substandard
healing. Also distinguishable from devices of the contemporary art,
embodiments of the present invention span the width of at least two
interspaces, thus eliminating the need for more than one device for
tight/secured closure over the same sternal area. The four securing
leg and foot structures of various embodiments of the present
invention improve pulmonary mechanics by assisting in the alignment
of ribs across the sternotomy allowing for simultaneous right and
left rib elevation symmetrically across the sternum and chest. The
projection member structures of various embodiments of the present
invention leverage the tight connections provided by fascia and
muscle, strengthens pulmonary compliance and allows for
distribution of energy and positioning strength to be spread evenly
throughout the sternum. Various embodiments of the present
invention enable fragmented segments of the sternum to be held in
place for healing, as opposed to single plate structures of the
contemporary art which concentrate (as opposed to distribute)
energy occasionally to a crushing central point thereby allowing
laterally displaced fragments to further displace.
BRIEF SUMMARY OF THE INVENTION
[0007] The present invention provides an improved device and method
for re-approximating the sternal halves of a patient's sternum
following a median or partial sternotomy, and facilitates ready
access to the thoracic cavity during or after a medical procedure
advanced the art by overcoming the sternal nonunion problems
inherent in prior art devices.
[0008] A sternum closure device in accordance with an embodiment of
the present invention includes a sliding attachment structure
including a plurality of projection members with angularly disposed
teeth-like structures inwardly positioned on the innermost edges of
each the plurality of projection members, and first and second leg
portions, each of the first and second leg portions including a
sliding attachment structure associated integrated foot portion and
a sliding attachment structure associated sternum engagement
portion. The sternum closure device includes a receiving attachment
structure including a securing aperture, and third and forth leg
portions, each of the third and fourth leg portions including a
receiving attachment structure associated integrated foot portion
and a receiving attachment structure associated sternum engagement
portion. The sternum closure device still further includes and a
generally bow-shaped locking member attached to the securing
aperture of the receiving attachment structure and including a
first distal end and a second distal end, each of the first distal
end and the second distal end including angularly disposed
teeth-like structures. The generally bow-shaped locking member is
resiliently tensioned between the plurality of projection members
such that the angularly disposed teeth-like structures of the
generally bow-shaped locking member engage the angularly disposed
teeth-like structures of the plurality of projection members.
[0009] The following disclosure teaches the structure and practice
of a method for a sternal closure device, which comprises
impermanently joined, sliding and receiving attachment structures
that are adapted for intercostal positioning between at least two
correspondingly positioned rib pairs substantially surrounding a
patient's sternum with each structure having a cross member, a
plurality of integrated leg and foot portions, a plurality of
sternum engagement surfaces, and an end portion.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 illustrates a frontal view of one embodiment of the
present invention as practiced in its joined or associated
state;
[0011] FIG. 2 illustrates a posterior view of one embodiment of the
present invention as practiced in its joined or associated
state;
[0012] FIG. 3 illustrates a side view of one embodiment of the
present invention as practiced in its joined or associated
state;
[0013] FIG. 4 illustrates a posterior view of one embodiment of the
sliding attachment structure with the locking member positioned
therein;
[0014] FIG. 5 illustrates distinguishable elements of one
embodiment of the present invention in a disassociated state;
[0015] FIG. 6 illustrates a posterior view of the present invention
intercostally positioned above and below at least two
correspondingly positioned rib pairs and substantially surrounding
a patient's sternum;
[0016] FIG. 7 illustrates a frontal view of the present invention
intercostally positioned above and below at least two
correspondingly positioned rib pairs and substantially surrounding
a patient's sternum;
[0017] FIG. 8 illustrates a frontal view of another embodiment of a
sliding attachment structure of a sternal closure device of the
present invention;
[0018] FIGS. 9A-9D illustrate the sliding attachment structure of
FIG. 8 after forming;
[0019] FIGS. 10A-10B illustrate another embodiment of a sternum
closure device assembly in an open configuration; and
[0020] FIGS. 11A-11B illustrate the sternum closure device assembly
of FIGS. 10A-10B in a closed configuration.
DETAILED DESCRIPTION
[0021] While the making and using of various embodiments of the
present invention are discussed in detail below, it should be
appreciated that the present invention provides for inventive
concepts capable of being embodied in a variety of specific
contexts. The specific embodiments discussed herein are merely
illustrative of specific manners in which to make and use the
invention and are not to be interpreted as limiting the scope of
the present invention.
[0022] While the invention has been described with a certain degree
of particularity, it is clear that many changes may be made in the
details of construction and the arrangement of components without
departing from the spirit and scope of this disclosure. It is
understood that the invention is not limited to the embodiments set
forth herein for purposes of exemplification, but is to be limited
only by the scope of the attached claim or claims, including the
full range of equivalency to which each element thereof is
entitled.
[0023] Referring to the drawings like numerals indicate like
elements, one embodiment of an improved sternum closure device
according to the present invention is shown in FIGS. 1 through
7.
[0024] The following disclosure teaches the structure and practice
of a method for a sternum closure device, which comprises
impermanently jawing, sliding and receiving attachment structures
that are adapted for intercostal positioning between at least two
correspondingly positioned rib pairs substantially surrounding a
patient's sternum with each structure having a cross member, a
plurality of integrated leg and foot portions, a plurality of
sternum engagement surfaces, and an end portion.
[0025] FIG. 1 illustrates a frontal view of one embodiment of the
present invention when practiced in a joined or associated state.
As can be seen in FIG. 1, a sliding attachment structure 3
comprises a cross member 5, a plurality of leg structures 7, and a
plurality of projection members 9 with each projection member 9
further embodying a number of angularly disposed teeth-like
structures 10 which are inwardly disposed and positioned on the
innermost edges of each the projection members 9.
[0026] Continuing with FIG. 1, the projection members 9 are
inserted through, generally u-shaped receiving chambers formed on
the lower most surface of receiving attachment structure 12
(receiving chamber not shown in FIG. 1, discussed further in
association with FIG. 2). Also shown in FIG. 1, is a connection
means, such as but not limited to, a screw, lock, pin, or other
similarly intended device 15 and a catch member (illustrated in
association with FIGS. 4 and 5) which is inserted through a
securing aperture 17 embodied within said receiving attachment
structure 12. The connection means providing an easily accessible
and expeditious means of engaging and disengaging attachment
structures 3 and 12, thereby allowing rapid removal of the
structure.
[0027] FIG. 2 illustrates a posterior view of one embodiment of the
present invention as practiced in its joined or associated state.
Referring now to FIG. 2, an embodiment of the receiving attachment
structure 12 is shown further illustrating its receiving chambers
13 through which the projection members 9 of sliding attachment
structure 3 are inserted. FIG. 2 further discloses a plurality of
sternum engagement surfaces 8, which are located at the terminus of
the integrated leg portions 7. In practice, the projection members
9 are slidably received into and through the receiving chambers 13
whereupon the projection members teeth-like structures 10 are
correspondingly engaged by a generally bow-shaped locking member 20
(shown in FIGS. 4 and 5) having teeth-like structures, such that
one-way traversing of said receiving chambers 13 is allowed. The
teeth-like structures 10 of each projection member 9 and the
locking member 20 further possess complimenting engagement surfaces
which allow for secure positioning once a desired closure position
has been realized. The locking member 20 and the projection members
9 form a one-way ratchet-type locking mechanism such that the
sternum closure device may be ratcheted into a closed position,
while opening of the sternum closure device is prevented. Further
discussion and disclosure of the interaction between the locking
member 20 and projection member 9 teeth-like surfaces 10 will be
provided in association with FIGS. 4 and 5.
[0028] FIG. 3 illustrates a side view of one embodiment of the
present invention as practiced in a joined or associated state.
Referring now to FIG. 3, further distinction may be observed with
respect to the foot portion 6, leg portion 7, and sternum
engagement surfaces 8 of one embodiment of the present invention. A
side view illustration of the engagement of the receiving chamber
13 is also provided, as is a beveled or otherwise angled projection
member positioning limitation structure 18. The positioning
limitation structure 18 is intended to provide the means by which a
maximum projection member insertion may be observed and/or
facilitated.
[0029] FIG. 4 illustrates a frontal view of one embodiment of the
sliding attachment structure 3 with the locking member 20
positioned therein. The locking member 20 is a resiliently
tensioned structure, typically, though not limitedly embodied of
the same material as the receiving and sliding attachment
structures 3 and 12. Still referring to FIG. 4, the projection
members 9 are shown with inwardly positioned angularly disposed
teeth-like structures 10 located on each of the projection members
9. The teeth-like structures 10 engage outwardly positioned
teeth-like structures 22 located at first and second distal ends
(26, 28) of the locking member 20 as the locking member 20 is
housed and accommodated within the posterior of the receiving
chambers 13. A securing aperture 24 is substantially centered
between the first and second distal ends (26, 28) of the locking
member 20. FIG. 4 allows comprehension and appreciation of the
one-way insertion orientation of the slidably adjustable sternum
closure device of various embodiments of the present invention.
[0030] FIG. 5 illustrates distinguishable elements of one
embodiment of the present invention in a disassociated state. Still
referring to FIG. 5, the locking member 20 may be observed in a
state in which it is not engaged with the angularly disposed
teeth-like structures 22 outwardly positioned at first and second
distal ends (26, 28) of the locking member 20. FIG. 5 further
provides a frontal view of the sliding attachment structure 3, as
well as a posterior view of the receiving attachment structure
12.
[0031] FIG. 6 illustrates a posterior view of an embodiment of a
pair of sternum closure devices of the present invention
intercostally positioned above and below at least two
correspondingly positioned rib pairs (31, 32) and substantially
surrounding a patient's sternum (50).
[0032] FIG. 7 illustrates a frontal view of an embodiment of a pair
of sternum closure devices of the present invention intercostally
positioned above and below at least two correspondingly positioned
rib pairs (31, 32) and substantially surrounding a patient's
sternum (50).
[0033] FIG. 8 illustrates a frontal view of another embodiment of a
sliding attachment structure 103 of a sternum closure device of the
present invention. Still referring to FIG. 8, the sliding
attachment structure 103 is illustrated in a pre-bent flat form. In
various embodiments, the sliding attachment structure 103 is laser
cut from a flat sheet of material. The flat form of the sliding
attachment structure 103 is then shaped by bending into the form
illustrated in FIG. 9. In various embodiments of the present
invention, the sliding attachment structure 103 of FIG. 8 is used
as an alternative to the sliding attachment structure 3 of in a
sternum closure device illustrated in FIGS. 1-7.
[0034] Still referring to FIG. 8, the sliding attachment structure
103 includes two projection members 109 that have inwardly
positioned angularly disposed teeth-like structures 110 located on
each of the projection members 109. The teeth-like structures 110
engage outwardly positioned teeth-like structures 22 located at
first and second distal ends (26, 28) of the locking member 20 of
FIGS. 4 and 5 as the locking member 20 is housed and accommodated
within the posterior of the receiving chambers 13. The sliding
attachment structure 103 further includes a cross member 105, and a
plurality of leg structures 107. Each of the plurality of leg
structures 107 further includes a foot portion 106 and sternum
engagement portions 108. The top surface of the sternum engagement
portions 108 and a portion of the foot portions 106 are formed with
a knurled or rough surface which aids in binding the sternum
engagement portions 108 to the sternum of the patient to prevent
movement of the sternum closure device after implantation. In
various embodiments of the present invention, the leg structures
107 and the projection members 109 are offset from each other by a
predetermined offset 119, whose function will be further discussed
with respect to FIGS. 9A-9D.
[0035] Still referring to FIG. 8, the projection members 109 of the
sliding attachment structure 103 may further include a plurality of
trim holes 111 which facilitate trimming of the projection members
109 to a desired length after implementation of the sternum closure
device by minimizing the amount of material that must be cut
through. The cross member 105 of the sliding attachment structure
103 may further be provided with a cut line 115 and cut holes 117
which function to aid in cutting apart of the cross member 105 to
allow quick release of the sternum closure device in situations in
which such a quick release is necessary or desirable. In other
embodiments, the cross member 105 may be scored with a line of
reduced thickness to provide a snap point for quick release of the
sternum closure device as an alternative to the cut line 115.
[0036] Referring now to FIGS. 9A-9D, the sliding attachment
structure 103 of FIG. 8 after forming is illustrated. Referring now
to FIG. 9A, a frontal view of the sliding attachment structure 103
after forming is illustrated. As discussed with respect to FIG. 8,
the leg structures 107 and the projection members 109 are offset
from each other by a predetermined offset 119. The function of the
predetermined offset 119 is for situations in which corresponding
ribs of a patient are not in alignment with each other. In one
embodiment of the invention, the predetermined offset 119 is equal
to three-sixteenths of an inch. It should be understood that
sliding attachment structures having a number of different
predetermined offsets may be provided as required by the particular
alignment of the patient's ribs. In still other embodiments, the
projection members 109 and the leg structures 107 may be angularly
offset from each other such that they are not aligned in a parallel
direction with respect to each other. In still other embodiments,
each of the leg structures may be angularly offset from each other
such that they are not parallel.
[0037] Referring now to FIG. 9B, an end view of the sliding
attachment structure 103 after forming is illustrated. Referring
now to FIG. 9C, a side view of the sliding attachment structure 103
after forming is illustrated. Referring now to FIG. 9D, a cross
sectional view of the sternum engagement portions 108 of the
sliding attachment structure 103 through a cross section A-A is
illustrated. As illustrated in FIG. 9D, the cross section sternum
engagement portion 108 is formed into a U-shape to prevent gouging
of the ribs or sternum by the edges of the sternum engagement
portion 108.
[0038] Referring now to FIGS. 10A-10B, another embodiment of a
sternum closure device assembly in an open configuration is
illustrated. FIG. 10A and FIG. 10B illustrate a frontal view and a
side view, respectively, of the sternum closure device assembly in
an open configuration. The sternum closure device includes a
sliding attachment structure 203 and a receiving attachment
structure 212. The sliding attachment structure 203 comprises a
cross member 205, a plurality of leg portions 207, and a plurality
of projection members 209 with each projection member 209 further
embodying a number of angularly disposed teeth-like structures 210
which are inwardly disposed and positioned on the innermost edges
of each the projection members 209. Each of the plurality of leg
portions 207 further includes a foot portion 206.
[0039] Continuing with FIGS. 10A-10B, the projection members 209
are inserted through receiving chambers 213 formed of the receiving
attachment structure 212. A connection means 215, such as but not
limited to, a screw, lock, pin, or other similarly intended device
and a catch member which is inserted through a securing aperture
217 embodied within the receiving attachment structure 212. The
connection means 215 providing an easily accessible and expeditious
means of engaging and disengaging the sliding attachment structure
203 and a receiving attachment structure 212, thereby allowing
rapid removal of the sternum closure device.
[0040] FIGS. 10A-10B further illustrates a plurality of sternum
engagement surfaces 208, which are located near the terminus of the
leg portions 207. In practice, the projection members 209 are
slidably received into and through the receiving chambers 213 of
the receiving attachment structure 212 whereupon the projection
members teeth-like structures 210 are correspondingly engaged by a
generally bow-shaped locking member 220 having teeth-like
structures, such that one-way traversing of the receiving chambers
213 is allowed. The teeth-like structures 210 of each projection
member 209 and the locking member 220 further possess complimenting
engagement surfaces which allow for secure positioning once a
desired closure position has been realized.
[0041] The generally bow-shaped locking member 220 is illustrated
in FIGS. 10A-10B as being positioned within the sliding attachment
structure 203. The generally bow-shaped locking member 220 is a
resiliently tensioned structure, typically, though not limitedly
embodied of the same material as the receiving and sliding
attachment structures 203 and 212. The locking member 220 of FIGS.
10A-10B is includes outwardly positioned teeth-like structures 222
located at each of opposed first distal end 226 and second distal
end 228. The teeth-like structures 222 engage the teeth-like
structures 210 of the sliding attachment structure 203 as the
locking member 220 is partially housed and accommodated within the
receiving chamber 213 of the receiving attachment structure 212.
The locking member 220 further includes a securing aperture 224
that is substantially centered between the first and second distal
ends (226, 228) of the locking member 220. The locking member 220
and the projection members 209 form a one-way ratchet-type locking
mechanism such that the sternum closure device may be ratcheted
into a closed position, while opening of the sternum closure device
is prevented.
[0042] The locking member 220 further includes first and second
extensions 230a and 230b extending from the first and second distal
ends 226 and 228, respectively. The first and second extensions
230a and 230b extend beyond the receiving chamber 213 of the
receiving attachment structure 212 to allow the first and second
extensions 230a and 230b to be squeezed towards one another, for
example, through use of pliers. The squeezing of the first and
second extensions 230a and 230b allow the teeth-like structures 222
of the locking member 222 to disengage from the teeth-like
structures 210 of the projection members 209 permitting the sternum
closure device to be opened.
[0043] Still referring to FIGS. 10A-10B, the projection members 209
of the sliding attachment structure 203 may further include a
plurality of trim holes 211 which facilitate trimming of the
projection members 209 to a desired length after implementation of
the sternum closure device by minimizing the amount of material
that must be cut through. The cross member 205 of the sliding
attachment structure 203 may further be provided with a cut line
218 and cut holes 219 which function to aid in cutting apart of the
cross member 205 to allow quick release of the sternum closure
device in situations in which such a quick release is necessary or
desirable. In other embodiments, the cross member 205 may be scored
with a line of reduced thickness to provide a snap point for quick
release of the sternum closure device as an alternative to the cut
line 218.
[0044] Still referring to FIGS. 10A-10B, the receiving attachment
structure 212 may be provided with a first clamp guide 232a, and
the sliding attachment structure 203 may be provided with a second
clamp guide 232b. In accordance with various embodiments, the first
claim guide 232a is a c-shaped cut in the receiving chamber 213 of
the receiving attachment structure 212, and the second clamp guide
232b is a c-shaped cut in the cross member 205 of the sliding
attachment structure 203. The first clamp guide 232a and the second
clamp guide 232b function to provide a guide for placement of a
clamp for clamping together the sliding attachment structure and
the receiving attachment structure of the sternum closure device
with a greater force than may be generated by hand.
[0045] Referring now to FIGS. 11A-11B, the sternum closure device
assembly of FIGS. 10A-10B is illustrated in a closed configuration.
FIG. 11A and FIG. 11B illustrate a frontal view and a side view,
respectively, of the sternum closure device assembly in a closed
configuration. In the closed configuration of FIGS. 11A-11B, the
sliding attachment structure 203 and the receiving attachment
structure 212 have been slide together into a fully closed position
such that the foot portions 206 of oppositely disposed leg portions
207 are in contact.
[0046] A significant advantage of various embodiments of the
present invention is to facilitate sternum closure via two separate
attachment structures from opposing sides which decreases the
amount of metal needed for clamping/securing structures. An
additional advantage of various embodiments of the present
invention is to provide for two independently adjustable locking
means which distribute the strength of a sternum closure, equally
and laterally, and essentially appose opposing rib segments along
the same plane.
[0047] Another advantage of various embodiments of the present
invention is to provide a device wherein the width of two separate
sequentially occurring rib intraspaces are associated with the
invention's clamping structures to eliminate need for multiple
devices to facilitate sternum closure over the same area. A further
advantage of various embodiments of the present invention is to
provide a small locking member and clamping apparatus which results
in decreased apparatus profile and weight but not closure
strength.
[0048] Yet another advantage of various embodiments of the present
invention is to provide for a single locking mechanism which
improves pulmonary mechanics by assisting in the alignment of the
ribs across a sternotomy, thus permitting simultaneous right and
left rib elevation symmetrically across the sternum and chest. A
further advantage of various embodiments of the present invention
is to provide for a single locking mechanism which leverages ribs
connected by fascia and muscle strengthening pulmonary compliance.
An additional advantage of various embodiments of the present
invention is to provide a mechanism and method by which the
distribution of closure energy and strength are spread evenly
throughout the sternum enabling even fragmented segments of the
sternum to be held in place for healing.
[0049] Yet another advantage of various embodiments of the present
invention is to provide an apparatus by which the strength of the
sternal closure is actually increased and distributed by means of a
double clamping mechanism over a correspondingly positioned rib
pair. An additional further advantage of various embodiments of the
present invention is to provide an apparatus by which the alignment
of apposing ribs actually increases the strength of the closure as
well as pulmonary force expiratory volume. Yet another advantage of
various embodiments of the present invention is to provide an
apparatus in which the edges are smooth to prevent dehiscence or
extrusion.
[0050] Another advantage of various embodiments of the present
invention is to provide for an easily accessible and expeditious
means by which sliding and receiving attachment structures may be
engaged to, and disengaged from on another. Another advantage of
various embodiments of the present invention is its single set
screw which when removed, allows rapid, complete disarticulation of
the apparatus allowing almost instantaneous surgical access in the
event of an emergency procedure.
[0051] Additional advantages of the invention are set forth, in
part, in the description which follows and, in part, will be
apparent to one of ordinary skill in the art from the description
and/or from the practice of the invention. These together with
other advantages of the invention, along with the various features
of novelty which characterize the invention, are pointed out with
particularity in the claims annexed to and forming a part of this
disclosure. For a better understanding of the invention, its
operating advantages attained by its uses, reference would be had
to the accompanying drawings, depictions and descriptive matter in
which there is illustrated preferred embodiments and results of the
invention.
[0052] It will be apparent to those skilled in the art that various
modifications and variations can be made in the construction,
configuration, and/or operation of the present invention without
departing from the scope or spirit of the invention. For example,
in the embodiments mentioned above, variations in the materials
used to make each element of the invention may vary without
departing from the scope of the invention. Thus, it is intended
that the present invention cover the modifications and variations
of the invention provided they come within the scope of the
appended claims and their equivalents.
[0053] While this invention has been described to illustrative
embodiments, this description is not to be construed in a limiting
sense. Various modifications and combinations of the illustrative
embodiments as well as other embodiments will be apparent to those
skilled in the art upon referencing this disclosure. It is
therefore intended that this disclosure encompass any such
modifications or embodiments.
* * * * *