U.S. patent application number 14/257273 was filed with the patent office on 2014-12-18 for flat suture banding system and methods.
This patent application is currently assigned to DALLEN MEDICAL, INC.. The applicant listed for this patent is David Trottingwolf Aldridge, Seth Arnold Foerster. Invention is credited to David Trottingwolf Aldridge, Seth Arnold Foerster.
Application Number | 20140371749 14/257273 |
Document ID | / |
Family ID | 50552747 |
Filed Date | 2014-12-18 |
United States Patent
Application |
20140371749 |
Kind Code |
A1 |
Foerster; Seth Arnold ; et
al. |
December 18, 2014 |
FLAT SUTURE BANDING SYSTEM AND METHODS
Abstract
A surgical tensioning device for holding separated tissues in
contact with one another. The device comprises a frame having two
opposing first and second sides and a lower surface and an upper
surface, and a band for extending through and around said separated
tissues to be held together in conjunction with said frame. The
band has two ends releasably attached to the sides of the frame.
When the ends are secured to the sides of the frame, the band holds
separated tissues together and establishes a path of tension along
its length that extends linearly between the two ends of the
band.
Inventors: |
Foerster; Seth Arnold; (San
Clemente, CA) ; Aldridge; David Trottingwolf; (Laguna
Hills, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Foerster; Seth Arnold
Aldridge; David Trottingwolf |
San Clemente
Laguna Hills |
CA
CA |
US
US |
|
|
Assignee: |
DALLEN MEDICAL, INC.
San Clemente
CA
|
Family ID: |
50552747 |
Appl. No.: |
14/257273 |
Filed: |
April 21, 2014 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
12836000 |
Jul 14, 2010 |
8715297 |
|
|
14257273 |
|
|
|
|
61225349 |
Jul 14, 2009 |
|
|
|
Current U.S.
Class: |
606/74 |
Current CPC
Class: |
A61B 2017/06014
20130101; A61B 17/823 20130101; A61B 17/06004 20130101; A61B 17/82
20130101; A61B 17/842 20130101; A61B 2017/681 20130101 |
Class at
Publication: |
606/74 |
International
Class: |
A61B 17/82 20060101
A61B017/82 |
Claims
1. A surgical tensioning device for holding separated tissues in
contact with one another, the device comprising: a frame having
opposing first and second sides, a lower surface, and an upper
surface; and a band for extending through and around the separated
tissues to be held together, in conjunction with said frame, said
band having a first end that is releasably securable to the first
side of said frame and a second end that is releasably securable to
the second side of said frame, wherein, when the first end is
secured to said first side after routing the first end through and
around said tissues and the second end is secured to said second
side of said frame, said band holds the previously separated
tissues in contact with one another and establishes a path of
tension along its length that extends linearly between the two ends
of the band.
2. The device of claim 1, wherein said first side of said frame
comprises a rigid member to which said first end of the band is
secured.
3. The device of claim 1, wherein said first end of said band is
directly attached to a needle.
4. The device of claim 3, wherein said first side of said frame
further comprises an integral slot that is sized and adapted to
mate and lock with an attachment mechanism which is disposed on the
first end of the band.
5. The device of claim 4 wherein said attachment mechanism
comprises a tapered face and is sufficiently rigid to promote
cutting through said tissue.
6. The device of claim 5, wherein said tapered face of the
attachment mechanism is sharpened to promote cutting through said
tissue.
7. The device of claim 1, and further comprising a bar movably
attached to the second side of said frame via a bar attachment,
said bar and bar attachment being adapted to hold said tension by
pinching said second band end between said bar and second frame
side.
8. The device of claim 7 wherein said bar has a circular cross
section and said bar attachment is adapted to constrain said bar
from rotational movement.
9. The device of claim 7 wherein said bar attachment is adapted to
mechanically constrain movement of said bar into the inside of said
frame and away from said upper surface about the second side of the
frame.
10. The device of claim 7 wherein said bar is attached inside the
frame at the second side via a bar attachment that is adapted to
mechanically constrain movement of said bar into the inside of said
frame and away from said upper surface about the second side of
frame.
11. The device of claim 7 wherein said bar is attached outside the
second side of said frame via a bar attachment that is adapted to
mechanically constrain movement of said bar into the inside of said
frame and away from said upper surface about the second side of the
frame.
12. The device of claim 1 wherein said band is substantially
flat.
13. The device of claim 12, where said band comprises suture.
14. The device of claim 7 wherein the surfaces of said bar and the
inside of said second side of said frame are textured.
15. The device of claim 3, and further comprising weakening
mechanisms in the first end of the band for facilitating separation
of the needle from the second end of the band.
16. The device of claim 15, wherein said weakening mechanisms
comprise notches.
17. A surgical tensioning device for holding separated tissues in
contact with one another, the device comprising: a frame, said
frame having two opposing first and second sides, said first side
comprising a rigid first member, a lower surface, and an upper
surface; a band for extending through and around said separated
tissues to be held together in conjunction with said frame, said
band having a first end that is releasably securable to the first
side of said frame at said first member, and a second end that is
releasably securable to the second side of said frame, wherein,
when the first end is secured to said first side after routing the
first end through and around said tissues and the second end is
secured to said second side of said frame, said band holds said
separated tissues together and establishes a path of tension along
its length that extends linearly between the two ends of the band;
and a bar moveably attached parallel to the second side of said
frame via a bar attachment, said bar and attachment being adapted
to hold said tension by pinching said second band end between said
bar and second frame side.
18. A method of repairing separated tissues using a tissue
tensioning device comprising a frame having opposing first and
second sides, a lower surface, and an upper surface, and a band
having a first end and a second end, the method comprising: routing
a needle attached to the second end of the band through the
separated tissues and into close proximity to the second side of
the frame; separating the needle from the second end of the band;
and securing the second end of the band to the second side of the
frame.
19. The method as recited in claim 18, wherein the separating step
is performed by cutting the needle away from the second end of the
band.
20. The method as recited in claim 18, wherein the securing step is
performed by wrapping the second end of the band around the second
side of the frame and tying a knot in the band.
21. The method as recited in claim 18, wherein the separating step
is performed by applying tension to the band at a point of weakness
in order to break the band.
22. The method as recited in claim 21, wherein the point of
weakness comprises a notch formed in the band.
23. The method as recited in claim 18, wherein the securing step
comprises inserting an attachment mechanism on the second end of
the band into a slot in the second side of the frame.
24. The method as recited in claim 23, wherein the attachment
mechanism comprises a tab which moves to an expanded position after
the tab passes through the slot, in order to secure the attachment
mechanism to the second side of the frame.
Description
[0001] This application claims the benefit under 35 U.S.C. 119(e)
of the filing date of Provisional U.S. Application Ser. No.
61/225,349, entitled Flat Suture Banding System, filed on Jul. 14,
2009, and expressly incorporated herein by reference, in its
entirety. This application is also related to co-pending U.S.
patent application Ser. No. 12/347,821, entitled Dynamic Suture
Tensioning Device and filed on Dec. 31, 2008, U.S. patent
application Ser. No. 12/406,902, entitled Knotless Dynamic Suture
Tensioning Device and Methods and filed on Mar. 18, 2009, U.S.
patent application Ser. No. 12/406,904, entitled Load Shaping for
Dynamic Tensioning Mechanisms and Methods and filed on Mar. 18,
2009, U.S. patent application Ser. No. 12/406,909, entitled Dynamic
Tissue Holding Device with Low Profile Spring and filed on Mar. 18,
2009, and U.S. patent application Ser. No. 12/815,989, entitled
Suture Band Buckle and Methods and filed on Jun. 15, 2010. All of
these related applications are commonly assigned and expressly
incorporated herein by reference, in their entirety.
BACKGROUND OF THE INVENTION
[0002] The present invention is related to the general surgical
repair of separated body tissues, and more particularly to
internally fixating and stabilizing such body tissues, specifically
bones.
[0003] In the present state of the art, there are a number of
systems available to repair biological tissues separated in surgery
or by injury. These products serve to approximate and stabilize the
tissues so that healing may commence and provide compression in the
interface to promote healing. Compression and stability are
critical for proper anatomical healing of tissue. With the correct
amount of compression applied to the interface of the tissue
portions to be joined, signals are sent to the tissue, thus
allowing the tissue to remodel in proper anatomical position. The
amount of compression applied to the tissue interface needs to be
appropriate to the type of tissue that is being healed.
[0004] Twisted wires are also typically used to keep bone fragments
together so they may heal. Twisted wires only hold tension as long
as the twisted wire pair remains stable. Often the wires untwist
too soon, thus failing to keep the bone fragments together so that
they may heal. Wires can also cut into the bone fragments, thereby
allowing them to separate so that healing is difficult.
[0005] When it is necessary to access the thoracic cavity for a
medical procedure, for example, it is required to cut the sternum
into two pieces using a sternal saw. Once the procedure is
completed within the thoracic cavity, the sternum must be repaired.
For such repairs, it is known to use a dynamic compression device,
such as the spring device A shown in FIG. 1. Some of the drawbacks
of this typical device A, and others which are used include:
[0006] 1. Bulky spring materials, while occupying substantial
space, often do not store much energy. Some use polymer elastic
bands, while other use coiled springs;
[0007] 2. Wires are sometimes used to wrap the bones into position
in compression with one another. However, wires can have sharp ends
that can damage adjunctive tissues, and the wires can also cut into
the bone, as mentioned above. Knot stacks in suture can interfere
with the natural movement of surrounding tissues; and
[0008] 3. Current banding systems that incorporate a biasing
mechanism to achieve dynamic compression put the biasing mechanism
in line with the band or suture. This practice competes with
precious space at the healing site. Suture or bands are used to
approximate tissues so that they may heal. It is desirable to
obtain the best purchase possible on the tissue, so that the
binding mechanics offered by the suture may be utilized. The best
purchase is optimized by ensuring that the suture has the greatest
contact area with the tissue. If a biasing mechanism is interfering
with this concept, the biasing mechanism may diminish the suture's
ability to hold the tissues together.
[0009] Bands are advantageous over wires for a number of reasons. A
band, by definition, is wide. In being wide, a band distributes its
forces over a wider surface area. This inhibits the band from
digging into the bone, unlike wires. In being wide, a band affords
a larger cross-sectional area whereby more material may be
realized, thus presenting the opportunity to offer as much strength
in the construct as is necessary to hold the bone fragments
together. As such, bands address wires' two main weaknesses,
namely, digging into the bone fragments being held together and,
not having sufficient cross sectional area.
[0010] Bands have different attributes than wires, some of which
are difficult to manage. With strength comes stiffness, as
mentioned elsewhere herein. The larger cross-section of the band
significantly increases the stiffness of the band. While stiffness
and rigidity are good attributes in that they can stabilize the
bone union, these attributes can also prevent the band from
following the contours of the bone when inserted. This can lead to
capturing tissues underneath the band that ultimately destabilize
the union as the tissues continue to compress and disappear over
time. Binding the band ends together can also impose some problems.
Generally this involves a mechanism on one band end that interfaces
with holes or slots or contours on the other band end. This creates
a tensioning system that is incremental in nature. As in the
twisted wire system, this mechanical interface of the two ends is
the weakest link in the system. This mechanical interface becomes
stronger as the incremental steps become larger. But larger
incremental steps aren't conducive to fine tuning the tension, so
this is problematic. Flat sutures have been used to tie tissues
together but the residual tension supplied in such a knotted
structure is insufficient for optimum healing. There is a lot of
fuss/time associated with trying to keep and hold a desirable
tension with these flat sutures. What is needed is an attachment
means that provides variable tensioning. Another problem associated
with all banding systems is that they tension by pulling
asymmetrically to one side requiring constant re-centering while
tensioning the band. What is needed therefore is a banding system
with the ability to tension symmetrically without requiring
re-centering of the band.
[0011] Buckles demonstrate many of the needed aspects of joining
two strap ends together in surgery. However, what is needed is a
buckle/strap system that has the ability to free one strap end from
the buckle such that it can be attached to a needle, routed through
tissue, simply detached from the needle, and then attached to the
buckle.
SUMMARY OF THE INVENTION
[0012] The present invention pertains to a surgical tensioning
device for holding separated tissues in contact with one another.
Improved devices and techniques are disclosed for holding two
tissue portions in a state of compression and tension that address
and overcome these shortcomings in an innovative way.
[0013] The present invention comprises a frame or a buckle frame.
The frame may be rigid and has two opposing first and second sides
and a lower surface and/or lower side and an upper surface and/or
upper side. The lower surface and/or lower side of the frame is the
surface and/or side that is in contact with the tissue(s) being
held together. In one embodiment, the two opposing first sides of
the frame may be parallel to one another. The device further
comprises a suture or band for extending through and/or around the
separated tissues to be held together in conjunction with said
frame. The suture or band has a first end, that is releasably
securable to the first side of the frame and a second end that is
releasably securable to the second side of the frame. Thus, when
the first end of the band is secured to said first side after
routing the first end through and/or around the tissues and the
second end is secured to the second side of said frame, said suture
or band holds the separated tissues in contact with one another and
establishes a path of tension along its length that extends
linearly between the two ends of the band.
[0014] In one embodiment, the band is sufficiently flexible to
provide tension along its length. In another embodiment, the band
or suture is substantially flat. Also, independently, in one
embodiment, a needle may be secured to either the first or second
end of the band or suture of the device. Preferably, the frame or
buckle has an opening that is sized appropriately to allow the
passage of a needle that is secured to an end of the band or
suture. In addition, the surfaces of the frame, for example, the
surfaces of the interior of the frame, are adapted to guide the
band so that the band can be easily threaded into the frame or
buckle. As discussed below, the surface of the bar and
corresponding mating surface on the frame may be textured or
roughened for holding the band more securely once tensioned.
[0015] In one aspect of the present invention, the first side of
the frame of the present device comprises a member around which
said first end of the band may be secured. The member may be in the
form of a pin or bar and may be rigid. In addition, in a preferred
embodiment, the first end of the suture or band may be directly
attached to a needle and may be secured to the first side of said
frame at the member on the first side with the aid of a knot after
being routed through and around said tissues. The member in the
first side of the frame may have a circular cross section or any
other cross section. In addition, the member may be textured or
roughened to provide improved performance, that is, to secure or
knot the first end of the band better relative to when the surfaces
are not textured, once the band is fully secured and tensioned.
[0016] In another aspect of the invention, the first side of the
frame may further comprise a slot. In this embodiment, the device
further comprises an attachment mechanism that is used to attach or
secure the first end of the suture or band at the slot in the frame
or buckle frame. The slot in the frame may be integral and is
preferably sized and adapted to mate and lock with the attachment
mechanism after the attachment mechanism has been routed through
and/or around said tissues. In this embodiment, the attachment
mechanism is preferably secured to first end of the band or suture
on one end and a needle on the other end. The attachment mechanism
may be secured to the first end of the suture or band via a loop.
The attachment mechanism preferably comprises a tab that can pass
through the slot in the frame. Once the attachment mechanism is
inserted into the slot, the tab inserts into the slot and then pops
out and engages into the slot, thus locking the attachment
mechanism at the slot on the first side of the buckle frame. In
addition, the attachment mechanism may comprise a tapered face and
may be sufficiently rigid to promote cutting through the tissue,
and furthermore, the tapered face of the attachment mechanism may
be sharpened to promote cutting through the tissue. The attachment
mechanism may further comprise notches designed to enable breaking
of the attachment mechanism at such pre-defined location.
Preferably such notches are used to easily remove or disengage the
needle from the attachment mechanism.
[0017] In still another aspect of the invention, the present device
further comprises a bar or pin that is moveably attached to the
second side of the frame via an attachment. The bar or pin and bar
attachment are adapted to hold tension across the suture or band by
pinching the second band end between the bar and the second frame
side. The bar attachment is adapted to mechanically constrain
movement of the bar into the inside of the frame and away from the
upper surface about the second side of frame. In addition, when the
bar or pin has a circular cross section, the bar attachment is
adapted to prevent rotational movement of the bar once it has been
engaged to pinch the second band end between itself and the second
frame side.
[0018] In yet another aspect of the invention, the bar is attached
outside the second side of the frame via the bar attachment. In
this embodiment, the bar attachment is adapted to mechanically
constrain movement of the bar into the inside of the frame and away
from the upper surface about the second side of frame. The bar can
have any profile. In one embodiment, its profile is round, that is,
it has a circular cross section. In the embodiment where the bar
has a circular cross section, the bar attachment is adapted to
prevent, in addition, rotational movement of the bar. Further, in
this embodiment, the space between the first and second sides of
the frame and the space between the bar and the outside of the
second side may be substantially similar and sized to allow said
band to pass through easily. Further, and independently, the
surfaces of the bar and the outside of the second side of the
frame, that is the mating surface for the bar, may be textured or
roughened to provide improved performance, that is, to secure the
second end of the band better relative to when the surfaces are not
textured, once the band is tensioned.
[0019] In accordance with the device described above, when the
second band end is routed around and through tissues being held
together and from the bottom up through the center of the frame and
over the second frame side and down between the second frame side
and bar such that when second band end is tensioned and released,
the bar holds the tension by pinching the band between the bar and
second frame side.
[0020] In another embodiment, the bar is attached inside the frame
at the second side of the frame via the bar attachment. In this
embodiment, preferably, a support or buttress is provided inside
the frame at the second frame side that includes an upper cam
surface. The bar is attached at the second frame side, via a bar
attachment, to the support on the upper cam surface of the support,
so that the upper cam surface is contiguous with the upper surface
of the frame at the second side of the frame. In this embodiment,
the bar attachment is adapted to mechanically constrain movement of
the bar into the inside of said frame and away from the upper
surface of the frame and away from the support about the second
side of frame. The bar can have any profile. In one embodiment, its
profile is round, that is, it has a circular cross section. In the
embodiment where the bar has a circular cross section, the bar
attachment is adapted to prevent, in addition, rotational movement
of the bar. The cam surface allows for supplying more leverage to
the hinging attachment mechanism such that the bar can be forced
harder into and be better locked inside the upper cam surface of
the support against the second frame side. Further, in this
embodiment, the space between the bar and the inside of the first
side of the frame and the space between the bar and the inside of
the second side are substantially similar and are sized to allow
suture or band to pass through easily. Further and independently,
the surfaces of the bar and the inside of the second side of the
frame, that is the mating surface for the bar, may be textured or
roughened to provide improved performance, that is, to secure the
second end of the band better relative to then the surfaces are not
textured, once the band is tensioned. In the embodiment of the
device where a needle is attached to the second end of the band,
the bar is adapted to move away from the second frame side to a
sufficient distance so as to allow the needle to pass around the
bar.
[0021] In accordance with the device described above, when the
second band end is routed around and through tissues being held
together and from the bottom up through the center of the frame and
over the bar and down between the bar and second side of frame such
that when second band end is tensioned and released, the bar holds
said tension by pinching the band between the bar and second frame
side.
[0022] In accordance with yet another embodiment of the present
device is described a surgical tensioning device for holding
separated tissues in contact with one another wherein the device
comprises a frame with two opposing first and second sides, which
are preferably parallel to each other, and a lower surface and/or
lower side and an upper surface and/or upper side. The lower
surface and/or lower side is the surface and/or side that is in
contact with the tissue(s) being held together. The device further
comprises a band or suture for extending around and/or through the
separated tissues to be held together in conjunction with the
frame. The band in this embodiment has a first end that is
releasably securable to the first side of the frame and, a second
end that is releasably securable to the second side of said frame.
When the first and second ends are secured to both first and second
sides of the frame, after either the first end or the second end or
both ends are routed through and round the separated tissues to be
held together, the band holds the separated tissues together and
establishes a path of tension along its length.
[0023] In accordance with yet another embodiment of the invention
is described a needle guide, adapted to be used in conjunction with
any of the devices described above. The purpose of the needle guide
is to mitigate or prevent any damage to the bars and attachments of
the devices when a large needle of the kind used in these surgical
repairs is used. The frame or buckle of the present devices has
been designed to be small because this is a desirable quality for
orthopedic implants. The needle used in these surgical repairs
needs to be abnormally large so that it can pierce sternal bone.
Sternal needles therefore are some of the largest needles made for
threading sutures. The present needle guide removably fits or
attaches to the frames of the present devices. The needle guide
comprises slots, preferably integral slots so that the needle guide
and slots are a single element, and is sized to fit via the slots
over the bar in order to restrain the bar which, when placed over
the bar, mitigates or prevents damage to the bar and bar attachment
from the needle.
[0024] Once the frame of the present devices has been threaded with
the suture and the bar(s) is set, the needle guide may be removed
as it has no further function. This is desirable as this lowers the
profile of the implant.
[0025] As used herein, the tissue portions to be held in contact
with one another in the present invention comprise biological
tissue in the body, including, but not limited to, skin, tendon,
bone, ligaments, blood vessels, and organs. In one embodiment, the
tissue portions comprise sternal bone that has been cut for a
procedure to access the thoracic cavity.
[0026] The dermal layer on top of the sternum is rather thin. Even
when a surgeon employs only twisted wire to repair the sternum,
some patients can feel that wire under their skin. Consequently,
the profile of a closure device can have cosmetic as well as
practical concerns. The dermal layer over the sternum on an average
adult female is 5 to 10 mm thick. A device that is .about.5 mm in
height is sufficiently thick to be rather clearly seen in some
adults. The profiles of the current inventive devices are spread
out over a large surface area, resulting in a much more favorable
aspect ratio, it will not be easily seen when viewing the patient
from the outside.
[0027] A particularly advantageous feature of the invention is that
the aspect ratio of the inventive device, defined as the height of
the device above the tissue surface, divided by the length of the
device, is less than or equal to approximately 0.50, and more
preferably approximately 0.10. In addition, the maximum height or
profile of the current inventive device at the frame preferably is
about 4 mm to about 1 mm
[0028] In certain embodiments, the buckle or frame of the device is
fabricated from either tempered stainless steel, spring tempered
stainless steel or titanium.
[0029] In certain embodiments of the present invention, the pins or
bars of the device are fabricated from either tempered stainless
steel, spring tempered stainless steel or titanium.
[0030] In certain embodiments of the present invention, attachments
or straps of the device are fabricated from either spring tempered
stainless steel or titanium.
[0031] In one embodiment, the band or suture of the present devices
is sufficiently flexible to provide tension along its length. In
yet another embodiment, the band or suture is substantially flat.
The suture or band may be defined by that which is normally
available. It may be woven fibers or a monofilament and can be any
material. Accordingly, the band may comprise woven, braided, or
knitted fibers or metals, or a monofilament, and can be made of any
known suture material. The suture may be of any shape, including,
but not limited to, round, square, oval, flat (like a strap), or
tubular. The shape of the suture or band for particular embodiments
will be discussed more fully herein below. In one embodiment of the
inventive device, the suture preferably comprises flat or tape
suture.
[0032] On one end of the suture or band may be a needle or other
receptacle to facilitate stitching or weaving in tissue or bone.
Accordingly, in one embodiment, a needle may be secured to the
second end of the band or suture of the device. Alternately, a
needle may be secured to both ends of the suture.
In another aspect of the invention, there is described an
advantageous method of repairing separated tissues using a tissue
tensioning device comprising a frame having opposing first and
second sides, a lower surface, and an upper surface, and a band
having a first end and a second end. The method comprises steps of
routing a needle attached to the second end of the band through the
separated tissues and into close proximity to the second side of
the frame, separating the needle from the second end of the band,
and securing the second end of the band to the second side of the
frame. In one embodiment of the invention, the separating step is
performed by cutting the needle away from the second end of the
band. The securing step is performed by simply wrapping the second
end of the band around the second side of the frame and tying a
knot in the band.
[0033] In another approach, the separating step is performed by
applying tension to the band at a point of weakness in order to
break the band. A disclosed point of weakness comprises one or more
notches formed in the band. Other known techniques, such as
perforation, for creating such points of weakness may be used as
well. The securing step comprises inserting an attachment mechanism
on the second end of the band into a slot in the second side of the
frame. The attachment mechanism comprises a tab which moves to an
expanded position after the tab passes through the slot, in order
to secure the attachment mechanism to the second side of the
frame.
[0034] The invention, together with additional features and
advantages thereof, may best be understood by reference to the
following description taken in conjunction with the accompanying
illustrative drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0035] FIG. 1 is a view showing a sternum and illustrating how
wires and bands might be used in binding sternal halves together
for healing after open heart surgery;
[0036] FIG. 2A is a top view of a common buckle;
[0037] FIG. 2B is a cross sectional view of the buckle in FIG. 2A
used with a strap;
[0038] FIG. 3A is a perspective view of plates used in a common
buckle;
[0039] FIG. 3B is a cross sectional view of the buckle in FIG. 3A
used with a strap;
[0040] FIG. 4 is a perspective view of a buckle design where wires
are used instead of plates;
[0041] FIG. 5A is a perspective view of a portion of a banding
suture system in accordance with an embodiment of the present
invention wherein one end of the suture is pre-threaded into a
buckle and the other end is attached to a needle;
[0042] FIG. 5B is a perspective view of the banding suture system
shown in FIG. 5A wherein both ends of the suture have been
secured;
[0043] FIG. 5C is a cross sectional view of the buckle into which
the second loose end of suture has been secured at the buckle;
[0044] FIG. 6A is a perspective view of a portion of a banding
suture system in accordance with an embodiment of the present
invention wherein one end of the suture is pre-threaded into a
buckle and the other end is attached to a needle;
[0045] FIG. 6B is a perspective view of the banding suture system
shown in FIG. 6A with the suture at the both ends secured;
[0046] FIG. 7A is a perspective view of a portion of a band suture
frame in accordance with an embodiment of the present invention
without the suture band;
[0047] FIG. 7B is a perspective view of the banding suture frame
shown in FIG. 7A including the suture with one end of the suture
secured into the buckle; and
[0048] FIG. 7C is a cross sectional view of the buckle into which
one end of suture has been secured.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0049] Referring now more particularly to the drawings, there is
shown in FIG. 1 an example of how wires and bands might be used in
binding sternal halves together for healing after open heart
surgery. As noted above, two different devices are shown side by
side, for comparative purposes. Device A is a prior art spring
device, while Device B is an inventive device described in related
application Ser. No. 12/406,909.
[0050] A strap locking system similar to that shown in FIG. 1, with
a common buckle 1 is represented in FIGS. 2A and 2B. A common
buckle 1, of a type sometimes used for straps on bags, is suitable
for use in this application because of its variable tensioning
abilities. Lock bar 2 moves surface 6 away from surface 8 when
strap tail 5 is tensioned. As strap tail 5 is tensioned, strap tail
4 is pulled into the 6/8 surface interface. When strap tail 5 is
released, strap tail 4 holds the dominate tension which pulls lock
bar 2 so that the strap is pinched between surfaces 6 and 8. This
is the locked position of the buckle 1. Locking bar 2 is held in
position by tabs on both of its ends. The tabs ride in a slot 10
which is cut out of frame 12. Slot 10 is critical in the operation
because it holds face 6 on locking bar 2 so that it correctly
pinches the strap against surface 8. The variability of the tension
in each of strap tails 4 and 5 cause the lock bar to move in slot
10. The lock bar naturally wants to even out these tensions by
rotating in slot 10. Flats are milled in the lock bar 2 ends to
ride in slot 10 so that such rotation does not happen.
[0051] This buckle 1 generally has the means to provide variable
tensioning to the strap loop. However with a suturing system, it is
necessary to have one of these strap ends free so that it may be
routed through tissue with a common suture-end-needle
arrangement.
[0052] Of course, a common buckle 1, such as that illustrated,
comes pre-threaded. What is needed to make a buckle suitable for a
suture application is to have the buckle designed so that it might
be threaded by the surgeon. In its common configuration, there is
not enough room around locking bar 2 to fit a suture needle.
[0053] The distance the locking bar 2 has to travel to achieve the
aforementioned locking and unlocking functionality is rather small.
Therefore, the slots 10 provided for accommodating the locking bar
ends are not long. Should the system be scaled down to the size of
a 5 mm wide suture band, the slot 10 only needs to be 0.020 inches
long. At this size, however, the slot does not provide bar travel
sufficient to allow a common needle, 0.065 inches in diameter, to
be threaded through the buckle. Furthermore, it would be difficult
to make this common buckle design open up enough to make such
threading easy. Surgeons would like to see an obvious opening for
the needle to pass through.
[0054] A strap locking system similar to common buckle 2 is
represented in FIGS. 3A and 3B. This system 14 shown in FIGS. 3A
and 3B comprises two plates 16 and 18 that are joined by strap loop
20 (shown in FIG. 3B) at one end. Plate 16 is made smaller than
plate 18 so that strap end 22 is pinched between adjoining surfaces
on plates 16 and 18 when threaded as shown in FIG. 3B and then
tensioned. The locking difference between plate system 14 and
common buckle 1 lays in the pinching mechanism. Plate system 14
moves plate 16 on a hinge to lock and release strap 22. Plate 16
can only lay parallel to plate 18 and thus the surfaces on the
locking mechanism are confined to plate surfaces as managed by the
hinging action. These constraints limit the effectiveness of the
locking abilities of plate system 14. The pinching surfaces are
commonly only lines. Common buckle 1 can have any approach to the
pinching system as defined by slot 10 and pinching surfaces 6 and 8
can be of any shape. Strap locking system 14 is interesting because
it can be easily threaded by a suture-needle construct.
[0055] FIG. 4 shows a similar buckle design as in FIG. 3 where
wires are used instead of plates. The pinching surfaces are only
opposing lines on either wire. As with the plate system 14, this
wire buckle system may be threaded with the loose strap end. This
works fine as long as the buckle is big enough to be manipulated
with fingers. But when the buckle gets small on the scale of a 5 mm
tape suture, the buckle becomes too small to manipulate for
threading.
[0056] The present invention is directed to a strap buckle system
that is prethreaded, has good strength holding characteristics, and
is small so as to be used with suture sized straps. Furthermore,
the present invention provides for holding the buckle open so that
it may be easily threaded by a needle/suture construct.
[0057] The tissue portions to be held in contact with one another
in the present invention comprise biological tissue in the body,
including, but not limited to, skin, tendon, bone, ligaments, blood
vessels, and organs. In one embodiment, the tissue portions
comprise sternal bone that has been cut for a procedure to access
the thoracic cavity. The suture may comprise woven, braided, or
knitted fibers or metals, or a monofilament, and can be made of any
known suture material. The suture may be of any shape, including,
but not limited to, round, square, oval, flat (like a strap), or
tubular. The shape of the suture for particular embodiments will be
discussed more fully hereinbelow. In one embodiment of the
inventive device, the suture preferably comprises flat or tape
suture.
[0058] In certain preferred embodiments, the buckle or frame of the
device is fabricated from either tempered stainless steel, spring
tempered stainless steel or titanium.
[0059] FIG. 5 represents one embodiment of the invention. As shown
in FIGS. 5A, 5B and 5C, a rigid frame 25 contains a member 26 on
one end or side and buckle 23 on the other end or opposing side end
with a member 32 linked via attachments 34 to frame 25 at this
opposing end or side. The member 26 is preferably in the form of a
substantially rigid pin or bar in this embodiment. The member 32 is
preferably in the form of a substantially rigid pin or bar in this
embodiment. Attachments 34 are preferably in the form of straps in
this embodiment. These attachment members that link the rigid pin
or bar 32 to the frame 25, are preferably constructed to yield to
slight pressure and form around frame 25. Pin or bar 32 ultimately
pinches the suture, band, or strap up against the inside surface of
frame 25 at 33. Suture or band or strap 24 has a first end or tail
31 that is attached to needle 28 at a junction 29, and is attached
to the frame 25 around bar or pin 26 as described herein. Suture or
band 24 is pre-threaded through the buckle 23 so that the other
tail or second end 27 of the suture or band is easily threaded into
buckle 23 through a window (not shown) held open by attachment
straps 34. As tension is applied to suture tail 27, the pin or bar
32 rotates to move from the outside of frame 25 to the inside of
frame 25. Attachment straps 34 yield and form around frame 25 in
this process. The straps serve to hold the pin in proper position
to pinch the suture against the inside surface of frame 25 when
tension is released on suture tail 27. Straps 34 also keep the bar
or pin 32 from rotating.
[0060] During surgery, the above embodiment is used as follows.
Needle 28 is routed through or around tissue and then into frame 25
and around pin 26. A knot 30 is then tied in the suture end around
pin 26. Needle 28 can be removed before or after this step by
simply cutting the suture/strap 24 at suture end 31 with scissors.
Buckle 23 is then activated to approximate tissues by pulling on
suture end 27. Locking pin 32 works in concert with straps 34 to
loosen the buckle, thereby allowing the suture to pass through the
buckle. When suture end 27 is released, suture gets pinched at 33
in the buckle 23.
[0061] In the above embodiment, the second end 27 of the
suture/strap 24 comes pre-threaded in the buckle. The other or
first end 31 comes attached to needle 28 for passing suture end
through tissue. First suture end 31 is then tied in a knot that
attaches it to the buckle. The needle is easily removable from the
suture end. The buckle/suture construct or flat suture band system
is now complete in a few easy steps, realizing the goals of the
present invention.
[0062] Although round bars or pins are shown as engaging against
flat surfaces in this embodiment, contoured pins with contoured
mating surfaces on the pin and frame respectively, may be used to
increase the buckle's holding performance. The mating surfaces,
contoured or otherwise, may be further roughened or textured if
more performance or better grip or holding is required.
[0063] In certain preferred embodiments of the present invention,
the pins or bars of the device are fabricated from either tempered
stainless steel, spring tempered stainless steel or titanium.
[0064] In certain preferred embodiments of the present invention,
attachments or straps of the device are fabricated from either
spring tempered stainless steel or titanium.
[0065] Buckle 23 has attachment straps 34 that perform the same
function as slot 10 does in the buckle 1, yet the buckle 23 is
simple enough to allow the free second end of suture 27 to be
threaded through the buckle. Attachment straps 34 provide the same
two functions slot 10 does in buckle 1; first to guide the pin into
its mating locking inside frame 25, and second to keep the pin or
bar 32 from rotating in the lock. Attachment straps 34 also hold a
window open to allow the threading of free suture end 27. Although
the buckles represented in FIGS. 3 and 4 are capable of being
threaded, it would be difficult to manage with gloved fingers on
such a small scale. This is all done in a low profile device as is
required for such surgical implants. A downsized version of buckle
1 would have a larger profile due to the material needed around the
slots.
[0066] FIGS. 6A and 6B show another advantageous embodiment of the
invention. In this embodiment, the knots 30 of the prior
embodiment, shown in FIG. 5B, are replaced with a different
attachment mechanism. The buckle 23 is otherwise as shown in the
prior embodiment. In this embodiment, the suture or strap 24 is
attached to a member or bar on the attachment mechanism 37 by means
of a loop 35. The frame 25, in the place of the member 26 on the
first side of the frame in the embodiment of FIGS. 5A-5C, has a
slot 38 that is sized and adapted to mate and lock with a member 36
in attachment mechanism 37. Attachment mechanism 37 is adapted to
follow needle 28 that is attached to attachment mechanism 37 at
junction 29 through the tissue and then become attached to buckle
frame 25. Attachment mechanism 37 comprises a tapered face 39 that
ends in junction 29 at which needle 28 is attached. Attachment
mechanism 37 may be made of any material that is rigid enough to
enable cutting tissues. Such material may comprise tempered
stainless steel or titanium, for example, in currently preferred
embodiments. In addition, the tapered face 39 might be further
sharpened to promote tissue cutting. The attachment mechanism
preferably has notches 40, or other suitable weakening mechanisms,
such as perforations, designed to enable breaking of the suture or
strap 24 at a predefined location. This enables easy removal of the
needle 28, without the need for a cutting implement, such as
scissors, and exposes tab 36 so that it may engage with slot
38.
[0067] This embodiment of the invention may be used as follows.
Needle 28 is routed through separated tissues and in doing so,
needle 28 brings attachment mechanism 37 and the attached suture or
strap 24 though these tissues. Needle 28 is brought into close
proximity to buckle frame 25. Attachment mechanism 37 is then
broken along notches 40. Attachment mechanism 37 is then inserted
into slot 38 in buckle frame 25. Attachment mechanism is then
inserted until tab 36 pops through slot 38 and expands, as shown,
thus locking the attachment mechanism 37 to buckle frame 25. Suture
or strap tail 27 is then pulled to bring the tissues together.
[0068] In the above embodiment, the second end 27 of the
suture/strap 24 comes pre-threaded in the buckle. The other or
first end 31 comes attached to needle 28 via an attachment
mechanism 37 for passing the suture end through tissue. First
suture end 31 is then attached to the buckle frame via the
attachment mechanism 37 after the easy removal of needle 28 using
the notches 40 in the attachment mechanism 37. The buckle/suture
construct or flat suture band system is now complete in a few easy
steps, realizing the goals of the present invention.
[0069] FIGS. 7A-7C illustrate still another embodiment of the
present invention, with a buckle 42 which is similar to the
embodiment in FIGS. 6A and 6B in that it has a similar frame 25
with a slot 38, and a bar or pin 32, as well as attachment straps
34. Alternatively, in another embodiment (not shown), the frame
could be similar to the frame 25 with a member 26 on the first
side, as shown in FIGS. 5A-5C. Accordingly, the suture band may be
secured at the first end 31 using an attachment mechanism 37 as
shown in FIGS. 6A-6B, wherein the tab 36 locks into slot 38, or, a
knot may be tied at the suture end 31 as shown in FIGS. 5A-5C when
the frame has a member 26.
[0070] In the embodiment depicted in FIGS. 7A-7C, straps 34 start
in the interior of the frame instead of outside the frame. This is
managed by placing a buttress 42 on the interior of the frame and
supplying a cam surface 44 to aid the straps in guiding the bar or
pin 32. Consequently space 36 is supplied inside the frame for
threading loose suture end 27. All the same advantages are realized
with buckle 42 as with buckle 23. Buckle 42 has the additional
advantage of having a simple threading route whereas the threading
route through buckle 23 is a bit more complicated.
[0071] The cam surface 44 and strap 34 combination provide the same
two functions as does slot 10 in FIG. 2; first to guide the pin
into its mating locking inside surface of frame 25, and second to
keep pin 32 from rotating in the lock. Cam surface 44 has the
additional advantage of supplying more leverage to the hinging
strap mechanism such that pin 32 is forced harder into and better
locked inside surface. Although round bars or pins are shown in
this embodiment, contoured pins with contoured mating surfaces on
the pin and frame respectively, may be used to increase the
buckle's holding performance. The mating surfaces, contoured or
otherwise, may be further roughened or textured if more performance
or better grip or holding is required.
[0072] While the inventive concept is disclosed as being
particularly adapted for use in repairing the sternum after a
thoracic cavity procedure, it is, of course, applicable to a great
many other procedures requiring repair of bodily tissue,
particularly bone.
[0073] Accordingly, although exemplary embodiments of the invention
have been shown and described, it is to be understood that all the
terms used herein are descriptive rather than limiting, and that
many changes, modifications, and substitutions may be made by one
having ordinary skill in the art without departing from the spirit
and scope of the invention, which is to be limited only in
accordance with the following claims.
* * * * *