U.S. patent application number 09/905064 was filed with the patent office on 2002-03-14 for strernum closure device and pincers for mounting staples and approximator brackets.
Invention is credited to Lemer, Joseph.
Application Number | 20020032465 09/905064 |
Document ID | / |
Family ID | 27417404 |
Filed Date | 2002-03-14 |
United States Patent
Application |
20020032465 |
Kind Code |
A1 |
Lemer, Joseph |
March 14, 2002 |
Strernum closure device and pincers for mounting staples and
approximator brackets
Abstract
A sternum closure device for securing parts of severed sternum,
such as a human sternum following surgery. The device includes an
anvil, capable of forming staples, a bracket positioned, opposite
the anvil, an instrument for creating openings in the sternum a
clamping mechanism and a mechanism for feeding, mounting and
applying the staples. The bracket is joined with the anvil through
a displacement mechanism. The instrument for forming opening is
designed as a bit brace having a reducing gear and two chucks, to
enable concurrent drilling of openings in both severed parts of the
severed sternum. The mechanism for feeding and mounting the staples
comprises a ribbed bed, a cartridge containing staples and an
instrument for mounting the staples. The clamping means enables
drilling of openings in both severed parts of sternum, and feeding
and mounting the staples. Specially designed pincers are also
provided for mounting the staples and other special staples. A
plurality of approximator brackets are provided for holding two
halves of a severed sternum for stapling.
Inventors: |
Lemer, Joseph; (Haifa,
IL) |
Correspondence
Address: |
Rashida A. Karmali, Esq.
Suite 1000
230 Park Avenue
New York
NY
10169
US
|
Family ID: |
27417404 |
Appl. No.: |
09/905064 |
Filed: |
July 13, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09905064 |
Jul 13, 2001 |
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09799475 |
Mar 5, 2001 |
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09799475 |
Mar 5, 2001 |
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09626802 |
Jul 27, 2000 |
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Current U.S.
Class: |
606/216 |
Current CPC
Class: |
A61B 17/823 20130101;
A61B 17/88 20130101; A61B 17/1693 20130101; A61B 17/0642 20130101;
A61B 17/0643 20130101; A61B 17/1691 20130101; A61B 17/0682
20130101; A61B 17/0644 20130101 |
Class at
Publication: |
606/216 |
International
Class: |
A61B 017/08 |
Claims
What is claimed is:
1. A sternum closure device for securing two parts of a severed
sternum having an external and internal side, said device
comprising: a. an anvil positioned on said internal side of said
severed sternum, said anvil being used for forming the staples, b.
a bracket situated on said external side of said severed sternum,
c. an instrument for forming openings in said severed sternum, and
d. a mechanism for feeding and mounting said staples.
2. The sternum closure device as claims in claim 1, wherein said
anvil, which serves for forming the staples, is designed in the
form of at least one slot.
3. The sternum closure device as claimed in claim 2, wherein said
anvil comprises at least one bend.
4. The sternum closure device as claimed in claim 2, wherein said
anvil comprises at least one opening.
5. The sternum closure device as claimed in claim 1, wherein said
bracket provides: a post having two openings and a pin mounted on
said post, and said post operatively connected to the instrument
for forming openings in the severed sternum, a lock comprising of a
housing having a slot, a spring actuated locking element having a
handle, said handle being situated in the slot.
6. The sternum closure device as claimed in claim 5, wherein said
bracket comprises at least one slot.
7. The sternum closure device as claimed in claim 6, wherein said
bracket comprises at least one bend.
8. The sternum closure device as claimed in claim 6, wherein said
bracket comprises at least one threaded opening and two through
openings.
9. The sternum closure device as claimed in claim 5, wherein said
post is installed on said bracket with possibility of its turning,
said post being provided with two openings with mutually
perpendicular axes and with a pin which is fastened on said
post.
10. The sternum closure device as claimed in claim 5, wherein said
lock is fastened on said bracket and said lock is constructed from
a housing and a locking element with handle.
11. The sternum closure device as claimed in claim 10, wherein said
housing of said lock comprises as least one slot.
12. The sternum closure device as claimed in claim 11, wherein said
locking element with said handle of said lock is provided with a
spring-wise element.
13. The sternum closure device as claimed in claim 1, wherein said
anvil and said bracket are joined mutually with a displacement
mechanism, said displacement mechanism providing reciprocating
displacement of said bracket toward said anvil and in back
direction.
14. The sternum closure device as claimed in claim 13, wherein said
displacement mechanism comprises a screw with a handle, said screw
is arranged in said threaded opening of said bracket and is
installed on said anvil to enable its rotation.
15. The sternum closure device as claimed in claim 13, wherein said
displacement mechanism comprises at least two guides, said guides
being arranged between said bracket and said anvil and being
fastened on said anvil.
16. The sternum closure device as claimed in claim 15, wherein said
guides are installed in said openings of said bracket to allow
displacement of said bracket along said guides.
17. The sternum closure device as claimed in claim 13, wherein said
displacement mechanism comprises a spring-wise element situated
between said anvil and said bracket, with coaxial arrangement of
said spring-wise element with respect to said screw.
18. The sternum closure device as claimed in claim 1, wherein said
instrument for forming openings in said sternum comprises one of
following mechanisms of the group: a manual bit brace, a pneumatic
bit brace, a laser perforator, or a ultra-sound perforator.
19. The sternum closure device as claimed in claim 18, wherein said
instrument for forming the openings is designed as a bit brace with
a reducing gear and is provided with at least two chucks for
installation of drills.
20. The sternum closure device as claimed in claim 19, wherein said
reducing gear comprises a housing with a lug, and at least three
gear wheels are positioned inside said reducing gear.
21. The sternum closure device as claimed in claim 20, wherein said
lug of said housing comprises at least one opening.
22. The sternum closure device as claimed in claim 20, wherein one
of said gear wheels is in engagement with both others.
23. The sternum closure device as claimed in claim 20, wherein one
of said gear wheels is installed on a shaft thereby serving to
joining with said drive.
24. The sternum closure device as claimed in claim 1, wherein said
mechanism for feeding and mounting said staples comprises a
carrying element, an assembly for mounting said staples, a
cartridge containing said staples, a plurality of stoppers, and a
spring-wise element.
25. The sternum closure device as claimed in claim 24, wherein said
carrying element is constructed as a bed with at least two ribs,
said ribs being arranged perpendicularly to the surface of said bed
and being provided with said limit stoppers.
26. The sternum closure device as claimed in claim 25, wherein each
of said ribs is provided with at least one slot.
27. The sternum closure device as claimed in claim 25, wherein said
surface of said bed is provided with at least one slot.
28. The sternum closure device as claimed in claim 25, wherein said
bed comprises at least one lug which is provided with at least one
threaded opening and a locking screw.
29. The sternum closure device as claimed in claim 25, wherein said
bed comprises at least one face wall which is provided with a
handle.
30. The sternum closure device as claimed in claim 24, wherein said
cartridge is provided with slots.
31. The sternum closure device as claimed in claim 30, wherein said
cartridge is arranged between said ribs of said bed and said
cartridge is provided with two pins which are situated in said
slots of said ribs.
32. The sternum closure device as claimed in claim 30, wherein said
spring-wise element is arranged between said cartridge and said
bed.
33. The sternum closure device as claimed in claim 1, wherein the
subassembly for mounting said staples comprises at least one lever
and at least two posts which are provided with spring-wise
elements.
34. The sternum closure device as claimed in claim 1, wherein the
anvil and the drilling instrument are controlled by a sliding
head.
35. The sternum closure device as claimed in claim 1, further
comprising a pincer for mounting the staples.
36. A pincer for mounting staples, said pincer comprising: a
plurality of handles, each of said handles having a first end
extending into a lever, and a second end in the shape of a jaw, the
two handles are joined together by an axle at the second end, and a
spring mechanisms holds the two levers together.
37. A specially designed staple, said staple comprising: a
plurality of legs, each of said legs having a threaded part, a
holder having two openings, said openings providing entry points
for installing the legs, and a spring attached to the holder and
being fastened by a nut.
38. A sternum closure device for securing two parts of a severed
sternum having an external and internal side, said device
comprising: an anvil positioned on said internal side of said
severed sternum, said anvil being used for forming the staples, a
bracket situated on said external side of said severed sternum, and
a clamping mechanism.
39. The sternum closure device as claimed in claim 38, wherein said
bracket provided a handle is installed on said bracket.
40. The sternum closure device as claimed in claim 39, wherein at
least one opening comprising in said bracket is constructed as
threaded opening.
41. The sternum closure device as claimed in claim 39, wherein said
handle provided a lever, said lever is fastened in said handle with
possibility of its turning.
42. The sternum closure device as claimed in claim 41, wherein said
lever is fastened on said handle with possibility of its
turning.
43. The sternum closure device as claimed in claim 38, wherein said
anvil and said bracket are fastened with an axle and are joined
mutually with a displacement mechanism.
44. The sternum closure device as claimed in claim 43, wherein said
displacement mechanism provides a turning of said bracket
relatively of said anvil around of said axle.
45. The sternum closure device as claimed in claim 44, wherein said
displacement mechanism comprises a screw with a handle, said screw
is arranged in said threaded opening of said bracket, said screw is
installed in said opening of said anvil with possibility of its
rotation.
46. The sternum closure device as claimed in claim 45, wherein said
screw is arranged in said threaded opening of said bracket, said
screw is installed in said opening of said anvil with possibility
of its rotation.
47. The sternum closure device as claimed in claim 46, wherein said
screw is installed in said opening of said anvil with possibility
of its rotation.
48. The sternum closure device as claimed in claim 38, wherein said
clamping mechanism is installed on said bracket providing
reciprocating displacement along said bracket.
49. The sternum closure device as claimed in claim 48, wherein said
clamping mechanism comprises: A carrying element, An assembly for
mounting said staples, A cartridge containing said staples, and A
lock fixing of said clamping mechanism on said bracket.
50. The sternum closure device as claimed in claim 49, wherein said
carrying element is constructed as a bed with at least one rib.
51. The sternum closure device as claimed in claim 50, wherein said
rib being arranged perpendicularly to the surface of said bed.
52. The sternum closure device as claimed in claim 51, wherein said
rib is provided with at least one cut.
53. The sternum closure device as claimed in claim 50, wherein said
bed comprises at least one guide-opening.
54. The sternum closure device as claimed in claim 49, wherein said
assembly for mounting said staples is fastened on said carrying
element.
55. The sternum closure device as claimed in claim 54, wherein said
assembly for mounting said staples is constructed as pressure
mechanism.
56. The sternum closure device as claimed in claim 55, wherein said
pressure mechanism comprises a pusher with a transmitting
element.
57. The sternum closure device as claimed in claim 56, wherein said
transmitting element being fastened to said pusher.
58. The sternum closure device as claimed in claim 49, wherein said
cartridge is fastened on said carrying element.
59. The sternum closure device as claimed in claim 58, wherein said
cartridge comprises a holder of said staples.
60. The sternum closure device as claimed in claim 59, wherein said
holder is provided with means for feeding of said staples.
61. The sternum closure device as claimed in claim 49, wherein said
lock is fastened on said carrying element.
62. The sternum closure device as claimed in claim 1, wherein said
lock is constructed as a housing comprising a locking element with
handle.
63. The sternum closure device claimed in claim 1 further
comprising a plurality of sternal approximator bracket.
64. The sternum closure device claimed in claim 63 wherein the
approximating brackets have a low profile and is useful in holding
two halves of a severed sternum until union of the halves is
achieved.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This Application is a Continuation-In-Part of co-pending
application Ser. No. 09/799,475 filed Mar. 5, 2001, which is a
Continuation-In-Part of co-pending application Ser. No. 09/626,802
filed Jul. 27, 2000, both of which are hereby incorporated by
reference specifically for disclosure on the sternum closure device
and in general, in its entirety.
FIELD OF THE INVENTION
[0002] The present invention relates to medical devices for closure
of a severed sternum and pincers for mounting staples and special
staples. In particular, the invention is directed to a sternum
closure assemblies and methods for re-approximating split portions
of tissue to retain the split portions in adjacent contacting
relation to promote healing thereof. Additionally, the invention is
directed to specially designed pincers which are used to bring the
two halves of the sternum and holds them firmly together without
movement so that the stapler can be used accurately.
BACKGROUND OF THE INVENTION
[0003] During surgery that involves a median sternotomy, for
example, open-heart surgery, the sternum is cut longitudinally to
allow access to the organs within the thoracic cavity. A partial or
median sternotomy is a procedure by which a saw or other
approximate 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 valves to be
separated laterally. Upon completion of the surgery, the sternum is
rejoined and closed securely.
[0004] Traditionally, the sternal halves have been closed with
stainless steel wires which are wrapped around or through the
sternal halves to engage in face-to-face relationship and
compressed together while the sternum heals. For example, in one
version, a surgical needle with the metal wire is led via both
split portions of a severed sternum and the free metal wire is
cut-off. In another version, the wire tips are further led via
openings in special staples, to project outside and the tips are
twisted together by tightening the suture, U.S. Pat. No. 4,512,346
and U.S. Pat. No. 5,849,012. However, these devices have certain
shortcomings, in that they require significant force, are difficult
to maneuver and the sharp wire edges sometimes cause injury and
eventually, infection to soft tissues.
[0005] Other prior art sternum closure assemblies include one or
two metal plates, these plates being provided with rows of
openings, through which extend the screws, pins, or metal wire, to
bring together the severed portions of the sternum. U.S. Pat. No.
4,585,341. These devices have drawbacks in that they are
ineffective in fixing the split portions of the severed sternum.
Moreover, they are foreign bodies in the thoracic cavity, and they
can cause disturbance in blood supply to the osseous tissue,
thereby prolonging healing and increasing chances of infection.
[0006] The strap assemblies known heretofore incorporate clamps,
clasps, bands, strips with or without openings and complex locking
mechanisms. U.S. Pat. No. 5,356,417; U.S. Pat. No. 5,462,542; and
U.S Pat. No. 6,007,538. The use of compression presents problems
for blood circulation and soft tissues. Other versions of sternum
closure devices use tongs, plugs or guns with anvils, to apply
staples through the osseous tissue of the sternum. U.S. Pat. No.
4,122,989; and U.S. Pat. No. 4,481,960. However, these devices
suffer from several drawbacks, for example, significant force is
required to puncture the osseous tissue and insert a staple. In
addition, these prior art devices are imprecise in positioning the
staples, and do not permit the anvil to bend the staple through
180.degree. angle. Finally, the devices are cumbersome and cause
shaking of the organs in the thoraxic cavity.
[0007] A certain amount of emphasis has also been directed towards
the use appropriate staples which minimize healing time, minimize
distortion of the material stapled, minimize damage of material
stapled, minimize scar tissue formation and achieve uniform
compression of stapled material. U.S. Pat. No. 5,342,396 and U.S.
Pat. No. 5,667,527. However, these devices suffer from several of
the same drawbacks discussed above for earlier models of the
sternum closure devices and systems.
[0008] It would accordingly be desirable to provide a sternum
closure device which is stable in construction and effectively
secures the severed portions of sternum or other tissue together,
i.e., secures the staples in well defined locations, at a
predetermined angle, and at a desirable tension to promote uniform
healing of the tissue portions while avoiding complications
associated with tissue injury, infection and compression. It would
also be desirable to provide an instrument which can bring the two
halves of the sternum and holds them firmly together without
movement so that the stapler can be used accurately.
[0009] The two halves of the severed sternum have to be held firmly
in place while the stapling process is being performed. Therefore
the present sternal approximating bracket has been invented to
perform this process quickly and more strongly than previous
inventions. It is suggested that 3 of these sternal approximating
brackets are placed so as to hold the two halves of the sternum
firmly.
SUMMARY OF THE INVENTION
[0010] The present invention provides improved devices and methods
of joining with staples, the opposite portions of a severed sternum
following a median or partial sternotomy that overcomes the above
cited problems inherent in previous sternum closure devices.
Generally, the present invention is embodied in an anvil for
bending the staples, a bracket positioned opposite the anvil, a
means for making openings in the tissue, and a means for feeding
and mounting the staples.
[0011] According to a first aspect of the invention, a sternum
closure device comprises an anvil having an element comprising two
slots, said element being used for bending the staples with
precision in a specific angular range up to 180.degree.. A bracket
is provided with an additional slot to guide the drilling means and
to mount the staples in the sternum. Other improvements to the
anvil and bracket include bending elements which facilitate their
mounting on the sternum portions. The bracket is provided with a
post and a lock, the post having two mutually perpendicular
openings and a pin mounted on it, and the lock comprising a housing
with a slot, and a spring-actuated locking element with a handle
situated in the slot.
[0012] According to a second aspect of the invention, the bracket
is joined with the anvil through a spring-actuated screw having a
handle, said screw being positioned in a threaded opening located
in the bracket. Two guides are situated between the anvil and the
bracket and parallel to the screw, said guides being installed in
the openings of the bracket to facilitate displacement of the
bracket with respect to the anvil.
[0013] The sternum closure device of the present invention
comprises a bit brace with a gear and two chucks having
interchangeable drills for simultaneously drilling openings in both
portions of a severed sternum. The gear includes a housing, said
housing including a basis with a lug, and a cover. The lug is
provided with an opening and a slot. A drive gear wheel is
installed on a driving shaft, said driving shaft being joined with
a pneumatic drive. Two drive gear wheels are in engagement with the
drive wheel gear. The drive wheel is fastened on the drive shafts
and the chucks with interchangeable drills are installed on these
drive shafts.
[0014] According to another aspect of the invention, the sternum
closure device comprises a means for feeding and mounting the
staples, including a carrying element constructed of a bed, said
bed having a first and second surface. Two ribs provided with a
positive stopper are situated perpendicularly to the bed surface.
The bed surface and each rib are provided with slots. The first bed
surface is also provided with a lug having a threaded opening and a
locking screw. The second and opposite bed surface is designed as a
wall having a handle. A sub-assembly used for mounting the staples,
is installed on the bed surface, said sub-assembly comprising an
L-shaped lever and two spring-actuated posts. Said L-shaped lever
has a shaft side and a long side. The two spring-actuated posts are
locked on the bed surface and passed through the openings in the
shaft side of the L-shape lever. The long side of the L-shaped
lever is placed in the slot of the bed surface.
[0015] A cartridge is placed between the bed ribs, said ribs having
an internal side and an external side. The cartridge comprises
slots for the staples and a spring-wise element situated between
the cartridge and the face wall of the bed. The spring-wise element
presses the cartridge with staples against a plurality of stoppers
installed on the internal side of the bed ribs.
[0016] According to a preferred embodiment of the invention, an
instrument for drilling openings is installed on the bracket post
along with precise and well-controlled means for feeding and
mounting staples. A compression spring is situated between the
instrument for drilling openings and the means for feeding and
mounting staples. The instrument for drilling opening may be
displaced from the bracket post when necessary.
[0017] According to yet another preferred embodiment of the
invention, especially designed pincers for mounting staples into
the severed sternum are provided. These pincers bring the two
halves of the sternum and holds them firmly together without
movement so that the stapler can be used accurately. These pincers
are not bulky nor do they interfere with the use of the stapler and
application of the staples.
[0018] The sternum closure device of the present invention
comprises a clamping mechanism installed on the bracket providing
reciprocating displacement along the bracket, and consisting of a
carrying element, an assembly for mounting the staples, a cartridge
containing the staples, and a lock fixing the clamping mechanism on
the bracket. The assembly, the cartridge, and the lock are fastened
on the carrying element. The carrying element is provided with two
guide-openings for drilling openings in the parts of the severed
sternum by one of any drilling instrument which is used in sternal
surgery.
[0019] According to another aspect of the invention, the sternum
closure device comprises a carrying element constructed of a bed,
having a rib provided with a cut and situated perpendicularly to
the bed. The assembly for mounting the staples, constructing as a
pressure mechanism comprises a pusher with a transmitting element
and spring-wise element. The transmitting element being fastened to
the pusher. The cartridge is fastened on the bed and comprises a
holder of the staples and means for feeding of the staples. The
means contains a pressure element is placed inside the holder. The
pressure element comprises a handle and spring-wise element. The
lock is fastened on the bed and is constructed as a housing
comprising a locking element with a handle and spring-wise element.
The locking element and the spring-wise element are placed inside
the housing.
[0020] In the present invention, the two halves of the severed
sternum have to be held firmly in place while the stapling process
is being performed. Therefore the present sternal approximating
bracket has been invented to perform this process quickly and more
strongly than previous inventions. It is suggested that 3 of these
sternal approximating brackets are placed so as to hold the two
halves of the sternum firmly.
[0021] The advantages of these sternal approximating brackets is
that: a) they have a low profile and so do not interfere with the
smooth performance of the stapling process, b) if compression
fixation of the sternum is anticipated (this is an accepted method
of external fixation in the treatment of various orthopedic
fractures), this sternal approximating bracket can be inserted
through the intact skin so as to compress the two halves of the
severed sternum and left in place until union has been
achieved.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] A more complete understanding of the present invention and
the attendant advantages and features thereof will be more readily
understood by reference to the following detailed description when
considered in conjunction with the accompanying drawings
wherein:
[0023] FIG. 1 is a side view of a sternum closure device positioned
in the state of drilling openings in the sternum.
[0024] FIG. 2 is a top view of the sternum closure device, taken in
the plane of FIG. 1.
[0025] FIG. 3 is a side view of the sternum closure device when it
is in the state of mounting staples.
[0026] FIG. 4 is a top view of the sternum closure device, taken in
the plane of arrow E. of FIG. 3 FIG. 5 is a front view of the
sternum closure device, taken in the plane of arrow B of FIG.
1.
[0027] FIG. 6 is a front view of the sternum closure device, taken
in the plane of arrow F. of FIG. 3.
[0028] FIG. 7 is a sectional view of the sternum closure device,
which is shown in Fig. 2, in the plane of line C-C; this device is
in the state preceding drilling the openings in the sternum.
[0029] FIG. 8 is a sectional view of the sternum closure device,
which is shown in FIG. 2, in the plane of line C-C; this device is
in the process of drilling the openings in the sternum.
[0030] FIG. 9 is a sectional view of the sternum closure device,
which is shown in Fig. 4, in the plane of line G-G; this device is
in the state preceding mounting the staples in the sternum.
[0031] FIG. 10 is a sectional view of the sternum closure device,
which is shown in FIG. 4, I the plane of line G-G; this device is
in the process of mounting the staples.
[0032] FIG. 11 is a sectional view in the plane of line D-D of a
displacement mechanism, which is shown in FIG. 1.
[0033] FIG. 12 is a view following detail I, which is shown in FIG.
7.
[0034] FIG. 13 is a sectional view of the sternum closure device,
which is shown in FIG. 8, in the plane of line H-H.
[0035] FIG. 14 is a sectional view of the sternum closure device,
which is shown in FIG. 9, in the plane of line K-K.
[0036] FIG. 15 demonstrates the closed sternum with the set of
mounted staples.
[0037] FIG. 16 is a side view of a sternum closure device
positioned in the state of drilling openings in the sternum.
[0038] FIG. 17 is a side view of the sternum closure device when it
is in the state of mounting staples.
[0039] FIG. 18 is a top view of the sternum closure device, taken
in the plane of arrow A of FIG. 1.
[0040] FIG. 19 is a top view of the sternum closure device, taken
in the plane of arrow L of FIG. 2.
[0041] FIG. 20 is a sectional view of the sternum closure device,
which is shown in FIG. 18, in the plane of line N-N; this device is
in the state preceding drilling the openings in the sternum.
[0042] FIG. 21 is a sectional view of the sternum closure device,
which is shown in FIG. 19 in the plane of line P-P; this device is
in the state preceding mounting the staples in the sternum.
[0043] FIG. 22 is a sectional view of the sternum closure device,
which is shown in FIG. 19, in the plane of line P-P; this device is
in the process of mounting the staples.
[0044] FIG. 23 is a sectional view of the sternum closure device,
which is shown in FIG. 20, in the plane of line R-R.
[0045] FIG. 24 is a sectional view of the sternum closure device,
which is shown in FIG. 22, in the plane of line S-S.
[0046] FIG. 25 demonstrates the closed sternum with the set of
mounted staples.
[0047] FIG. 26 is a side view of the pincers for mounting
staples.
[0048] FIG. 27 is a butt view of the pincers for mounting staples,
taken in the plane of arrow A of FIG. 16.
[0049] FIG. 28 is a butt view of the pincers for mounting staples,
taken in the plane of arrow B of FIG. 16.
[0050] FIG. 29 is a side view of the pincers with special staple,
taken in the plane of arrow C of FIG. 17.
[0051] FIG. 30 is a side view of the special staple, which is shown
in FIG. 19.
[0052] FIG. 31 is a sectional view of the special staple, which is
shown in FIG. 20 in the plane of line D-D.
[0053] FIG. 32 is a side view of the pincers with special staple
before setting of the special staple on the severed sternum.
[0054] FIG. 33 is a side view of the pincers with special staple
after setting of the special staple on the severed sternum.
[0055] FIG. 34 is a side view of the sternal approximator
bracket.
[0056] FIG. 35 is a sectional view of the sternal approximator
bracket, which is shown in FIG. 34 in the plane of line X-X.
[0057] FIG. 36 is a side view of the sternal approximator bracket
before setting of the sternal approximator bracket on the severed
sternum FIG. 37 is a side view of the sternal approximator bracket
after setting of the sternal approximator bracket on the severed
sternum.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0058] According to yet another preferred embodiment of the
invention, especially designed pincers for mounting staples into
the severed sternum are provided. These pincers bring the two
halves of the sternum and holds them firmly together without
movement so that the stapler can be used accurately. These pincers
are not bulky nor do they interfere with the use of the stapler and
application of the staples.
[0059] The sternum closure device of the present invention
comprises a clamping mechanism installed on the bracket providing
reciprocating displacement its along of the bracket, and consisting
of a carrying element, an assembly for mounting the staples, a
cartridge containing the staples, and a lock fixing the clamping
mechanism on the bracket. The assembly, the cartridge, and the lock
are fastened on the carrying element. The carrying element is
provided with two guide-openings for drilling openings in the parts
of the severed sternum by one of any drilling instrument are in use
in sternal surgery.
[0060] According to another aspect of the invention, the sternum
closure device comprises a carrying element constructed of a bed,
having a rib provided with a cut and situated perpendicularly to
the bed. The assembly for mounting the staples, constructing as a
pressure mechanism comprises a pusher with a transmitting element
and spring-wise element. The transmitting element being fastened to
the pusher. The cartridge is fastened on the bed and comprises a
holder of the staples and means for feeding of the staples. The
means contains a pressure element is placed inside the holder. The
pressure element comprises a handle and spring-wise element. The
lock is fastened on the bed and is constructed as a housing
comprising a locking element with a handle and spring-wise element.
The locking element and the spring-wise element are placed inside
the housing.
[0061] Referring to FIGS. 1 to 13, a sternum disclosure device 1 is
shown to provide a system and method for joining two portions 2 and
3, of a severed sternum 4, by means of staples 5, having legs 6 and
7, which are inserted through openings 8 and 9 of the severed
sternum 4.
[0062] A preferred embodiment of the sternum closure device
includes an anvil for bending staples. This anvil is positioned on
the internal side of the severed sternum. A bracket is situated on
the outer side of the severed sternum, opposite the anvil. The
anvil comprises an element for bending the staples. It is designed
to have two slots. In addition, the bracket has a third slot which
is intended to be guide for the drills and for mounting the staples
on the sternum. The unique feature about the present invention is
that the anvil and the bracket are designed with bends such that
these bends facilitate their proper mounting on the sternum.
[0063] The bracket is also provided with a rotatable post and a
lock. The post is provided with two mutually perpendicular openings
and a pin. The lock comprises of a housing with a slot. A
spring-actuated locking element having a handle is situated in the
slot in the lock housing.
[0064] Referring to FIG. 1, the sternum device 1 comprises of an
anvil 10 and a bracket 20, said anvil and said bracket being joined
together by a displacement means 40. The sternum device 1 further
comprises of an instrument 60 which is provided to form openings in
the sternum, and a staple feeding means 100, which is used for
feeding and mounting the staples.
[0065] Referring to FIGS. 1 and 9, anvil 10 is provided with two
slots 11 and 12 for the purpose of bending staples 5, a bend 13 and
a through opening 14 used for joining the displacement means 40.
The bracket 20 comprises of a through slot, a bend 22 and a
threaded opening 23, said opening 23 serving to attach the
displacement means 40. The bracket 20 further comprises of two
through openings 24 and 25, and a cylindrical post 26. The
cylindrical post 26 is installed on bracket 20 to provide a turning
means, the cylindrical post being further provided with two
openings 27 and 28, and a pin 39. A lock 31 is installed
traversally to cylindrical post 26 and the lock 31 is fastened on
bracket 20.
[0066] The bracket is joined to the anvil through a displacement
mechanism. This mechanism provides reciprocating displacement of
the bracket with respect to the anvil. The displacement mechanism
comprises of a spring-actuated screw with a handle. This screw is
positioned in the threaded opening in the bracket where it is
attached to the anvil. Two guides are situated between the anvil
and the bracket. These guides are parallel to the screw and are
locked in the anvil. The guides are installed in the through
openings of the bracket to enable its displacement in the direction
of the guides.
[0067] Referring to FIGS. 1 and 9, the anvil 10 and bracket 20 are
joined via the displacement means 40 to enable reciprocating
displacement of bracket 20 to and from the anvil 10. The
displacement means comprises of screw 41, said screw extending into
a handle 42, a compression spring 43 and two guides 44 and 45. The
screw 41 is fastened through a threaded opening 23 in bracket 20,
and is locked rotatably in the opening 14 of anvil 10. A spring 43
is installed between the anvil 10 and the bracket 20, in line with
the screw 41. Guides 44 and 45 are locked onto the anvil 10 and are
in a parallel position to screw 41. Guides 44 and 45 are installed
in such a way through openings 24 and 25 of bracket 20 to enable
displacement of bracket 20 along guides 44 and 45.
[0068] Referring to FIG. 10, lock 31 comprises of housing 32, a
locking element 33, a spring 34 and a handle 35. The locking
element 33 and the spring 34 are introduced partially into housing
32, and the locking element 33 is presented from dropping out by
the handle 35, said handle 35 being installed in a slot 36 located
in the housing 32.
[0069] In a preferred embodiment of the sternum closure device, the
instrument for formation of openings in the sternum is constructed
as a hand bit brace, a pneumatic bit brace, a laser perforator or
an ultra-sound perforator. The bit brace comprises of a gear and
two chucks. These chucks have interchangeable drills for
simultaneously drilling openings in both portions of the severed
sternum, which are to be attached.
[0070] The gear consists of a housing. The housing includes a basis
with a lug and a cover. The lug is provided with a through opening
and a slot. A plurality drive of gear wheels each installed on a
driving shaft. The driving shaft is then joined to a pneumatic
drive. Chucks with interchangeable drills are also installed on the
drive shafts.
[0071] Referring to FIGS. 1, 2, 5, 7 and 8, an instrument 60 is
provided for formation of openings. The instrument is constructed
as a bit brace 61 with a pneumatic drive 62 and two chucks 63 and
64. The two chucks are provided for mounting interchangeable drills
65 and 66. The instrument 60 further comprises a gear 71. Gear 71
is installed over housing 72, said housing comprising of a basis 73
and a cover 74. Base 73 is provided with lug 75, said lug 75 having
an opening 76 and a slot 77. A driving gearwheel is arranged in the
internal space of housing 72, and installed on a driving shaft 79.
The driving shaft 79 is mounted on base 73 of housing 72 by means
of bearings 86, 87, 88 and 89. The driving shaft 79 is further
completed with the pneumatic drive 62, said drive being designed as
a pneumatic motor. Chucks 63 and 64 are installed on driving shafts
84 and 85 and these chucks are used for mounting the
interchangeable drills 65 and 66.
[0072] Instrument 60 and pin 29 are installed on cylindrical post
26 to enable displacement along the cylindrical post 26. The pin 29
is locked on cylindrical post 26 via slot 77 of lug 75 of gear 71.
Thus, pin 29 limits the magnitude of instrument 60 and prevents its
turning around post 26.
[0073] A portable means of feeding and mounting the staples is
constructed as a bed with two ribs situated perpendicularly to the
bed surface. The ribs are provided with a positive stopper. The bed
surface and each rib are provided with through slots. One bed
surface is provided with a lug, the lug having a threaded through
opening and a locking screw in it. The other bed surface is
designed as a wall with a handle.
[0074] Referring to FIGS. 3, 4, 6, 9, 10 and 14, a feeding and
staple mounting means 100 comprises of a carrying element
constructed as bed 101 having two ribs 102 and 103. These ribs are
perpendicular to bed 101 and each rib is provided with longitudinal
slots 104 and 105. Stoppers 106 and 107 are installed on the
internal side of each rib 102 and 103, respectively. Bed 101 is
provided with two lugs 108 and 109, said lugs in turn are provided
with openings 110 and 111 respectively. Bed 101 is further provided
with slot 112, said slot 112 being placed in parallel to sides 113
and 114 of bed 101. Side 113 is provided with lug 115, which in
turn has an opening 116 and a locking screw 117 fastened to the
opening 116. Wall 118, having an internal side and an external
side, is situated in perpendicular to bed 101 on side 114. Handle
119 is locked to wall 118. A cylindrical support 120 is further
installed on the internal side of wall 118.
[0075] Feeding means 100 further comprises of a cartridge 131 which
is positioned between ribs 102 and 103 of bed 101, and a spring
132. Cartridge 131 is designed as a parallel component having slots
133 used for positioning the staples 5. A bracket 135 having an
opening 136 is positioned on face side 134 of cartridge 131.
Cartridge 131 is installed between ribs 102 and 103 and is held
inside the bed 101 by two pins 137 and 138. These two pins are
positioned in slots 104 and 105 of ribs 102 and 103 respectively.
Spring 132 is arranged in a cylindrical support 120 of wall 118. It
is further inserted partially in opening 136 of bracket 135.
[0076] Feeding means 100 further comprises subassembly 141, used
for mounting the staples. The subassembly 141 comprises a pressure
L-shaped lever 142, two posts 143 and 144, and two springs 145 and
146. The L-shaped lever 142 has a short side 147, the short side
147 having two openings 148 and 149. Posts 143 and 144 pass through
openings 148 and 149 respectively. Springs 145 and 146 are
installed singly on posts 143 and 144 respectively. The subassembly
141 is installed on bed 101. The L-shaped lever has a long side
150, which is introduced in slot 112. Posts 143 and 144 and springs
145 and 146 are locked through openings 110 and 111 of lugs 108 and
109, respectively.
[0077] Staple feeding means 100 is mounted on post 26 and
instrument 60 and locked in place by a screw 117. In addition,
spring 161 is installed on feeding means 100 and instrument 60.
OPERATION OF THE STERNUM CLOSURE DEVICE
[0078] The mode of operation of the sternum closure device is
described herein below.
[0079] The bracket 20 is moved progressively in direction away from
anvil 10 by the displacement mechanism 40 (see FIG. 11). The screw
41 is rotated by handle 42, for example, in an anti-clockwise
direction. Bracket 20 moves progressively along guides 44 and 45 in
direction away from anvil 10 with releasing spring 43. This results
in greater distance between anvil 10 and bracket 20. Anvil 10 and
bracket 20 are positioned correspondingly from the internal and
external sides of portion 2 and 3 of the severed sternum 4.
[0080] Bend 13 of anvil 10 and bend 22 of bracket 20 facilitate
mounting anvil 10 and bracket 20 on sternum 4.
[0081] With rotation of screw 41 by handle 42 in the opposite
direction (in this case--in the clock-wise direction), bracket 20
moves progressively along guides 44 and 45 towards anvil 10. This
motion is accompanied with compression of spring 43 and decrease of
the distance between anvil 10 and bracket 20 in reference to the
internal and external portions 2 and 3 respectively, of the severed
sternum 4.
[0082] The sternum closure device 1 is arranged in the position of
drilling openings in portions 2 and 3 of the severed sternum 4
(FIGS. 1, 2, 5, 7) by lock 31 (FIG. 12).
[0083] In the initial state spring 34 of lock 31 is released and
the locking element 33 is placed in one of two mutually
perpendicular through openings 27 or 28 of post 26 of bracket 20.
As displacement handle 35 moves along slot 36, the locking element
33 is removed from the corresponding openings 27 or 28 of post 26
by compression of spring 34. Then post 26 is released from locking
and it turns in bracket 20 until the axis of the through opening 27
is aligned with the axis of the locking element 33 of lock 31. With
descending handle 35 the compressed spring 34 pushes out the
locking element 33 from housing 32. The locking element is
introduced in such a way into the through opening 27 of the post
26, that it fixes in a position of the drilling openings.
[0084] Drilling openings 8 and 9 are performed in portions 2 and 3
of the severed sternum 4 (FIGS. 7, 8) by instrument 60 intended for
drilling openings. This instrument is installed on post 26 of
bracket 20 to allow its reciprocating motion along post 26. Then
the pneumatic motor 62 is switched on. The motor via the drive gear
wheel 78 and two driven gear wheels 82 and 83 of gear 71 causes two
chucks 63 and 64 to rotate with drills 65 and 66 respectively (FIG.
7). By pushing in direction of arrow PUSH onto cover 74 of gear 71
of instrument 60, the bit brace 61 is displaced along post 26 of
bracket 20 toward anvil 10. This displacement is accompanied by
compression of spring 161 and drills 65 and 66, which pass via slot
21 of bracket 20. Openings 8 and 9 are drilled simultaneously
correspond to two portions 2 and 3 of the severed sternum 4 (FIGS.
8, 13). The magnitude of displacement of instrument 60 along post
26 is limited by the length of slot 77 and the limiting pin 29
(FIGS. 8, 13). With completion of drilling opening 8 and 9 (see
FIG. 13), compression on instrument 60 is stopped. It returns to
its initial position by release of spring 161 (see FIG. 8).
[0085] Then the sternum closure device 1 is transferred in the
state of mounting staples 5 in sternum 4 (FIGS. 3, 4, 6, 9) by lock
31 (FIG. 12). With displacement of handle 35 of lock 31 along slot
36, the locking element 36 is removed from the through opening 27
of post 26, and compresses spring 34. Then post 26 is released and
it is turned in bracket 20 until the axis of the through opening 28
is aligned with the axis of the locking element 33 of lock 31. With
descending handle 35 the compressed spring 34 pushes out the
locking element 33 from housing 32. Then this locking element is
introduced into the through opening 28 of post 36 fixings in such a
way that it facilitates mounting of the staples.
[0086] Mounting staples 5 in the through openings 8 and 9 in
respective portions 2 and 3 of the severed sternum 4 (see FIGS. 9,
10) is performed by mechanism 100 of feeding and mounting staples.
This is accomplished by locking mechanism 100 on post 26 of bracket
20. Cartridge 131 is filled by staples 5 through slots 133. When
mounting the staples, the locking mechanism is set above the
through slot 21 of bracket 20. Cartridge 131 with staples 5 are
forced from Cartridge 131 onto stoppers 106 and 107 by spring 132
(FIG. 10). While pushing in direction of arrow PUSH on the short
side 137 of the L-shaped lever 142, the cartridge is displaced
along two posts 143 and 144 towards anvil 10. This is accompanied
by compression of springs 145 and 146. The long side 150 of the
L-shaped lever 142 passes via the through slot 112 and presses out
the first staple 5 from the through slot 133 of cartridge 131. This
staple is introduced in turn via the through slot 21 of bracket 20
by its two legs 6 and 7 corresponding to openings 8 and 9 in
portions 2 and 3 respectively, of the severed sternum 4. With
further pushing on the short side 147 of the L-shaped lever 142,
legs 6 and 7 of staple 5 pass via openings 8 and 9. The form of
legs 6 and 7 is changed with bending because of slots 11 and 12 of
anvil 10, while pulling together portions 2 and 3 of the severed
sternum 4 (FIGS. 10, 14).
[0087] The angle in which the two legs of the staple bend is
circular and effectively secures the two divided portions of the
sternum in a stable grip. The present invention is directed to a
sternum closure device which securably retains a plurality of
staples around sternum portions to maintain the portions in
adjacent engaged relation during healing. The present invention
minimizes damage of a tissue stapled and prevents formation of scar
tissue.
[0088] After mounting of staple 5 is completed the compression
(FIG. 5), on lever 142 is terminated. It returns to its initial
position owing to release of springs 145 and 146 (FIG. 9). After
egress of the long side 150 of L-shaped lever from the through slot
133 of cartridge 131, spring 131 is released. The cartridge 131 is
displaced through one further step until the next staple 5 is
arranged in through slot 133, with stoppers 106 and 107 (FIGS. 9,
14). In order to mount additional staple 5, bracket 20 is displaced
progressively away from anvil 10 by the displacement mechanism 40
(FIG. 11). Rotation of screw 41 by handle 42 in an anti-clock wise
direction allows displacement of bracket 20 progressively along
guides 44 and 45 toward anvil 10. This release spring 43 and
enlarges the distance between anvil 10 and bracket 20.
[0089] Then the sternum closure device 1 is made ready for mounting
the next staple 5. This process of mounting displacing and
compressing staple 5 is repeated as necessary.
[0090] When mounting of all required staples 5 is completed (the
closed sternum with all mounted staples is shown in FIG. 15), the
sternum closure device 1 is removed.
[0091] Referring to FIG. 16, the sternum closure device 1 comprises
of an anvil 210 and a bracket 220, the anvil and the bracket are
joined together by a displacement mechanism 240. The sternum
closure device 1 further comprises of an clamping mechanism 260,
which is used for forming openings and mounting the staples 5 in
the sternum 4.
[0092] Referring to FIGS. 16, 20-24, anvil 210 is provided with two
slots 211 and 212 for the purpose of forming staples 5, a opening
213 used for joining the displacement mechanism 240. The bracket
220 comprises of a through slot 221 and a threaded opening 222,
said opening 222 serving to join the displacement mechanism 40.
[0093] The bracket is joined to the anvil through a displacement
mechanism. This mechanism provides turning of the bracket with
respect to the anvil. The displacement mechanism comprises of a
screw with a handle. This screw is positioned in the threaded
opening in the bracket where it is joined to the anvil.
[0094] Referring to FIGS. 16-24, the anvil 210 and bracket 220 are
joined via the displacement mechanism 240 and are fastened with an
axle 241 to enable turning of bracket 220 to and from the anvil
210. The displacement mechanism 240 comprises of screw 242, said
screw 242 extending into a handle 243. The screw 242 is fastened
through a threaded opening 222 in bracket 220, and is locked
rotatable by spherical element 244 in the opening 213 of anvil
210.
[0095] Referring to FIGS. 16, 17, 20 and 22, the bracket 220 is
provided with a handle 223, said handle 223 is installed on the
bracket 220. The handle 223 provided a lever 224, the lever 224 is
fastened on handle 223 by an axle 225 with possibility of its
turning. The lever 224 have two ends 226 and 227, the end 226 is
arranged inside the handle 223, the end 227 is free and is arranged
from outside the handle 223. In initial position (FIGS. 16, 17, 20
and 21) the lever 224 is holding by spring 228. The bracket 20 also
is provided with two openings 229 and 230 for fixing the clamping
mechanism 260 on the bracket 220.
[0096] In a preferred embodiment of the sternum closure device, the
clamping mechanism comprises a carrying element, an assembly for
mounting staples, a cartridge containing staples, and a lock fixing
of the clamping mechanism on the bracket.
[0097] The carrying element is constructed as a bed with one rib is
situated perpendicularly to the bed surface. The rib is provided
with one cut. The bed comprises also two guide-openings.
[0098] The assembly for mounting staples is fastened on the bed and
is constructed as pressure mechanism comprising the pusher with the
transmitting element. The transmitting element being fastened to
the pusher.
[0099] The cartridge is fastened on the bed and comprises a holder
of the staples and means for feeding of the staples.
[0100] The lock fixing of the clamping mechanism on the bracket is
fastened on the bed and is constructed as a housing comprising a
locking element with a handle.
[0101] The clamping mechanism 260 consists of the carrying element,
which is constructed as the bed 261 with the rib 262 being arranged
perpendicularly to the surface of the bed 261, the assembly 270 for
mounting staples 5 is fastened on the bed 261, the cartridge 280
containing staples 5 is fastened on the bed 261, and the lock 290
fixing of the clamping mechanism 260 on the bracket 220. The rib
262 of the bed 261 is provided with the cut 263 and the bed 261
comprises two guide-openings 264 and 265.
[0102] The assembly 270 for mounting staples 5 constructing as the
pressure mechanism comprises the pusher 271 with the transmitting
element 272 and spring-wise element 273. The transmitting element
272 being fastened to the pusher 271.
[0103] The cartridge 280 is fastened on the bed 261 and comprises a
holder 281 of the staples 5 and means 282 for feeding of the
staples 5. The means 282 contains a pressure element 283 is placed
inside the holder 281. The pressure element 283 comprises a handle
284 and spring-wise element 285.
[0104] The lock 290 fixing of the clamping mechanism 260 on the
bracket 220 is fastened on the bed 261 and is constructed as a
housing 291 comprising a locking element 292 with a handle 293 and
spring-wise element 294. The locking element 292 and spring-wise
element 294 are placed inside the housing 291.
[0105] The bracket 220 comprises also two openings 229 and 230 for
fixing the locking element 292 of the lock 290.
[0106] The mode of operation of the embodiment of the sternum
closure device is described herein below.
[0107] The bracket 220 is turned in direction away from anvil 210
by the displacement mechanism 240 (see FIG. 20). The screw 242 is
rotated by handle 243 in threaded opening 222 of the bracket 220,
for example, in a counter clockwise direction. Bracket 220 turns
around axle 241 in direction away from anvil 210. This results in
greater distance between anvil 210 and bracket 220. Anvil 10 and
bracket 220 are positioned correspondingly from the internal and
external sides of parts 2 and 3 of the severed sternum 4.
[0108] With rotation of screw 242 by handle 243 in the opposite
direction (in this case--in the clockwise direction), bracket 220
turns around axle 241 towards anvil 210. This motion is accompanied
with decrease of the distance between anvil 210 and bracket 220 to
contact with the internal and external parts 2 and 3 respectively,
of the severed sternum 4.
[0109] The sternum closure device 1 is arranged in the position of
drilling openings in parts 2 and 3 of the severed sternum 4 (FIGS.
16, 18, 20 and 23) by lock 290 (FIG. 5). In the initial state
spring 294 of lock 290 is released and the locking element 292 is
placed in one of two openings 229 or 230 of bracket 220 (in this
case--in the opening 230).
[0110] Drilling openings 8 and 9 are performed in parts 2 and 3 of
the severed sternum 4 (FIG. 23) by one of any drilling instrument,
which are used in sternal surgery (for example, pneumating bit
brace--not shown on the drawings). Openings 8 and 9 are drilled by
turns correspond to two parts 2 and 3 of the severed sternum 4
through two guide-openings 264 and 265 of bed 261 of clamping
mechanism 260 (FIG. 23).
[0111] After drilling openings 8 and 9 the clamping mechanism 60 is
transferred in the state of mounting staples 5 in sternum 4 (FIGS.
17, 19, 21, 22, 24) by lock 290 (FIGS. 20, 22). The locking element
292 is removed from the opening 230 of the bracket 220 by means of
lifting the handle 293 compressing spring 294. Then move the
clamping mechanism 260 along the bracket 220 until the opening 230
of the bracket 220. With descending handle 293 the compressed
spring 294 releases and the locking element 292 sets in the opening
229 of the bracket 220.
[0112] Mounting staples 5 in the through openings 8 and 9 in
respective parts 2 and 3 of the severed sternum 4 (FIGS. 22, 24) is
performed by assembly 270. Before mounting staples the cartridge 80
is filling in the staples 5. The filling of the staples
accomplishes with displacement to back of handle 284 of the means
282 compressing spring 285. The staples 5 are setting on the holder
281. With descending handle 284 the compressed spring 285 pushes
out the pressure element 283, which pressing of the staples 5 to
rib 262 of the bed 261. With raising of the lever 224 by the end
226 (FIG. 22) the spring 228 is stretching, and the lever 224 turns
around the axle 225. The free end 227 of the lever 224 presses to
the pusher 271 of the assembly 270 compressing the spring 273. The
pressure passes by the transmitting element 272 to the staple 5.
The first staple 5 is introduced via the slot 221 of the bracket
220 by its two legs 6 and 7 corresponding to openings 8 and 9 in
parts 2 and 3, respectively, of the severed sternum 4. With further
pushing on the pusher 271 of the assembly 270, legs 6 and 7 of the
staple 5 (FIG. 24) pass via openings 8 and 9. The form of legs 6
and 7 is changed with bending of slots 211 and 212 of the anvil
210, while pulling together parts 2 and 3 of the severed sternum 4
(FIGS. 24, 29).
[0113] The angle in which the two legs of the staple bend is
circular and effectively secures the two severed parts of the
sternum in a stable grip. The present invention is directed to a
sternum closure device, which securably retains a plurality of
staples around sternum parts to maintain the parts in adjacent
engaged relation during healing. The present invention minimizes
damage of a tissue stapled and prevents formation of scar
tissue.
[0114] After mounting of staple 5 is completed raising the end 226
of the lever 224 is terminated. It returns to its initial position
owing to release of springs 228. After return the lever 224 to the
initial position, the pusher 271, transmitting element 272 and
spring 273 of the assembly 270 are released and returned to initial
position. With return transmitting element 272 to the initial
position, the pressure element 283 of the means 282, which pressing
the next staples 5 to rib 262 of the bed 261 and partially releases
spring 285.
[0115] In order to mount next staples 5, bracket 220 is displaced
progressively away from anvil 210 by the displacement mechanism
240. Rotation of screw 242 by handle 243 in the counter clockwise
direction allows turning of the bracket 220 relative to the anvil
210 around of the axle 241. It enlarges the distance between anvil
210 and bracket 220.
[0116] Then the sternum closure device 1 is made ready for mounting
the next staple 5. This process of mounting displacing and
compressing staple 5 is repeated as necessary.
[0117] When mountings of all required staples 5 is completed (the
closed sternum 4 with all mounted staples is shown in FIG. 25) the
sternum closure device 1 is removed.
[0118] Referring to FIGS. 26 to 33, the pincers 300 are shown to
provide a system and method for temporarily joining two parts 2 and
3, of a severed sternum 4, by means of special staples 301, having
legs 302 and 303.
[0119] Referring to FIGS. 26-28, the pincers 300 comprise of a
handle 311 with a jaw 312 is intended for setting of the special
staple 301, and a lever 321 with a jaw 322 which is intended for
extension of the special staple 301. The handle 311 and the lever
321 are jointed together by an axle 331 which permits turning of
the levers, and a spring 332 which facilitates the return in the
initial position.
[0120] Referring to FIGS. 26-29, the handle 311 is provided with a
slot 313 for the purpose of passing the jaw 322 of the lever 321 at
the time of its turning. The jaw 312 of the handle 311 is provided
a cut section 314 for setting of the special staple 301. The jaw
322 of the lever 321 comprises of a opening 323 for holding of the
special staple 301.
[0121] Referring to FIGS. 30-31, the special staple 301 is provided
with the legs 302 and 303. The leg 302 is changeable, any leg 302
may have a different length, the length of the leg 302 being
selecting in accordance with the width of the severed sternum 4.
The length of the leg 303 is constant. The legs 302 and 303 are
provided with threaded parts 304 and 305 respectively. The legs 302
and 303 are installed in a holder 306, which comprises two openings
307 and 308. The special staple 301 also comprises a spring 309 and
a nut 310. The leg 302 by its threaded part 304 is screwed into
threaded opening 307, and the leg 303 is inserted into the holder
through the opening 308. The spring 309 is installed inside the
holder through the opening 308 from one side to the opposite side
of the leg 308. The spring 309 is fastened by means the nut
310.
[0122] The mode of the operation of the pincers for mounting
staples is described herein below.
[0123] In initial position the special staple 301 is installed in
the pincers 300 so that the threaded part 305 of the leg 303 is put
into opening 323 of the jaw 322, and the other side of the leg 303
is put into cut 314 of the jaw 312 (see FIG. 29).
[0124] By pushing in the direction of the arrow PUSH onto the lever
321, it turns around the axle 331. The spring 332 compresses, and
the jaw 322 presses on the threaded part 305 of the leg 303. The
spring 309 compresses and the leg 303 pulls out from the opposite
side of the opening 308, while a distance between free ends of the
legs 302 and 303 is extending. In this position the pincers 300
with the special staple 301 are set on the severed sternum 4 (see
FIG. 32). After setting of the special staple 301 on the severed
sternum 4, the lever 321 is released in direction of arrow RELEASE.
The spring 332 is released, the lever 321 is turned around the axle
331 backwards, the spring 309 of the special staple 301 is released
also, and the legs 302 and 303 are pressed to the parts 2 and 3 the
severed sternum 4 (see FIG. 33). The pincers 300 are removed from
the special staple 301.
[0125] For the mounting of the next special staples 301, the
operation is repeated.
[0126] Referring to FIGS. 24 to 32, a sternum closure device 1 is
shown to provide a system and method for joining two parts 2 and 3,
of a severed sternum 4, by means of staples 5, having legs 6 and 7,
which are inserted through openings 8 and 9 of the severed sternum
4.
[0127] A preferred embodiment of the sternum closure device
includes an anvil for forming staples. This anvil is positioned on
the internal side of the severed sternum. A bracket is situated on
the outer side of the severed sternum, opposite the anvil. The
anvil comprises an element for forming the staples. It is designed
to have one slot. In addition, the bracket has a second slot which
is intended to guide the drills and for mounting the staples on the
sternum.
[0128] The unique feature about the present invention is that the
anvil and the bracket are fastened with the axle and are jointed by
means of the displacement mechanism that provides reliable holding
of the device on the severed sternum.
[0129] The second unique feature about the present invention is
that the lever is fastened in the handle of the bracket such that
facilitates mounting of the staples on the severed sternum.
[0130] Referring to FIGS. 34 to 37, the sternal approximator
bracket 401 is shown to provide a system and method for temporary
or permanent joining two parts 2 and 3, of a severed sternum 4, by
means of sternal approximator brackets 401, having legs 402 and
403.
[0131] Referring to FIGS. 34, 35 said leg 403 comprises the
threaded stud 404 and nut 405. Said leg 402 consists non-through
rectangular opening 406 and through opening 407. Said leg 403
inserted into said opening 406, said stud 404 inserted into said
opening 407 and prominent part of said stud 404 and screwed with
said nut 405.
[0132] The mode of operation of the sternal approximator bracket is
described herein below.
[0133] In initial position said leg 403 of the sternal approximator
bracket 401 is positioned into said leg 402 so that said stud 404
projects from said leg 402 and screwed with said nut 405 (see FIG.
34).
[0134] With setting said sternal approximator bracket 401 on said
severed sternum 4 said legs 402 and 403 slide apart by unscrew said
nut 405 (see FIG. 36). Then said sternal approximator bracket 401
is installing on said severed sternum 4 and said nut 405 is
screwing along said stud 404 by any spanner or ratchet, which gives
the best fit. Said parts 2 and 3 said severed sternum 4 are
pressing tightly and fixing (see FIG. 37).
[0135] Removing said sternal approximator bracket 401 from said
severed sternum 4 executes in the back order.
[0136] The present invention provides a relatively simple and less
traumatic means to effect sternum closure which can be performed
rapidly and effectively by the surgeon. While the above description
contains many specifics, these specifics should not be construed as
limitations on the scope of the invention, but merely as
exemplification of preferred embodiments thereof. Those skilled in
the art will envision many other possible variations that are
within the scope and spirit of the invention as defined by the
claims appended hereto.
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