U.S. patent application number 14/714700 was filed with the patent office on 2015-09-10 for lagwire system and method for the fixation of bone fractures.
This patent application is currently assigned to ORTHOIP, LLC. The applicant listed for this patent is ORTHOIP, LLC. Invention is credited to KISHORE TIPIRNENI, WAYNE VASSELLO.
Application Number | 20150250503 14/714700 |
Document ID | / |
Family ID | 45804250 |
Filed Date | 2015-09-10 |
United States Patent
Application |
20150250503 |
Kind Code |
A1 |
TIPIRNENI; KISHORE ; et
al. |
September 10, 2015 |
LAGWIRE SYSTEM AND METHOD FOR THE FIXATION OF BONE FRACTURES
Abstract
A lagwire system and method for facilitating the fixation of
bone fractures is disclosed. The lagwire system includes an anchor
component, a wire, a sleeve and a cap. The sleeve and cap are
operable to slide along the length of the wire and also operable to
be used to fixate a fracture individually by using a canal prepared
by the anchor and wire.
Inventors: |
TIPIRNENI; KISHORE;
(GLENDALE, AZ) ; VASSELLO; WAYNE; (LAKE WORTH,
FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ORTHOIP, LLC |
BOCA RATON |
FL |
US |
|
|
Assignee: |
ORTHOIP, LLC
BOCA RATON
FL
|
Family ID: |
45804250 |
Appl. No.: |
14/714700 |
Filed: |
May 18, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13118871 |
May 31, 2011 |
9060809 |
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14714700 |
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12898975 |
Oct 6, 2010 |
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13118871 |
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12860122 |
Aug 20, 2010 |
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12898975 |
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12491132 |
Jun 24, 2009 |
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12860122 |
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12265890 |
Nov 6, 2008 |
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12491132 |
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12235405 |
Sep 22, 2008 |
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12265890 |
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11952715 |
Dec 7, 2007 |
8828067 |
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12235405 |
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11742457 |
Apr 30, 2007 |
8702768 |
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11952715 |
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11678473 |
Feb 23, 2007 |
8679167 |
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11742457 |
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10779892 |
Feb 17, 2004 |
7591823 |
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11678473 |
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10272773 |
Oct 17, 2002 |
6736819 |
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10779892 |
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60330187 |
Oct 18, 2001 |
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Current U.S.
Class: |
606/62 |
Current CPC
Class: |
A61B 17/86 20130101;
A61B 17/8685 20130101; A61B 17/8863 20130101; A61B 2017/681
20130101; A61B 17/72 20130101; A61B 17/8625 20130101; A61B 17/842
20130101; A61B 17/8605 20130101; A61B 17/746 20130101; A61B 17/7053
20130101; A61B 17/8869 20130101; A61B 17/92 20130101; A61B 17/888
20130101; A61B 17/685 20130101; A61B 17/62 20130101; A61B 17/861
20130101; A61B 17/683 20130101; A61B 17/864 20130101 |
International
Class: |
A61B 17/68 20060101
A61B017/68; A61B 17/86 20060101 A61B017/86; A61B 17/88 20060101
A61B017/88; A61B 17/72 20060101 A61B017/72 |
Claims
1. An implant device comprising: a wire having a first end and a
second end, wherein the second end of the wire is configured to be
cut to a particular length; an anchor attached to the first end of
the wire, wherein the anchor is configured to be fixedly attached
to a first bone portion, wherein the anchor includes anchor
threads; a cap attached to the second end of the wire; and a
flexible sleeve having a first sleeve end and a second sleeve end,
wherein the flexible sleeve is configured to slide longitudinally
over the wire such that the wire is reciprocally received by the
flexible sleeve, after the anchor is fixedly attached to the first
bone portion, wherein the flexible sleeve is configured to be
inserted into a bone canal that spans across a fracture between the
first bone portion and a second bone portion, wherein the anchor is
configured to receive the first sleeve end, such that the anchor
threads and outer threads on the first sleeve are contiguous, and
wherein threads on the cap and the outer threads on the second
sleeve end are continguous.
2. The implant device of claim 1, wherein the anchor includes
tapered threads behind cutting threads, such that the tapered
threads are configured to cut into the first sleeve end to secure
the first sleeve end to the anchor.
3. The implant device of claim 1, wherein the flexible sleeve is
configured to be cut to a particular length, after the anchor is
fixedly attached to the first bone portion.
4. The implant device of claim 1, wherein the flexible sleeve is
configured to bend while inside the bone canal in any radial
direction relative to its centerline into a curved
configuration.
5. The implant device of claim 1, wherein the outer thread of the
sleeve is configured to be threaded into at least a portion of the
bone canal and provide friction against at least a portion of the
bone canal.
6. The implant device of claim 1, wherein the flexible sleeve is
configured to engage the anchor to fixedly attach the flexible
sleeve to the anchor, after the anchor is fixedly attached to a
first bone portion.
7. The implant device of claim 1, wherein the anchor includes
external anchor threads.
8. The implant device of claim 1, wherein the flexible sleeve at
least partially includes at least one of shape memory material,
plastic, polyetherketone (PEEK), steel, titanium or titanium
alloy.
9. The implant device of claim 1, wherein the flexible sleeve is
configured to allow treatment to be delivered through a center of
the flexible sleeve, wherein the treatment includes at least one of
a medication, an adhesive, an ultrasonic vibration, or a bonding
material.
10. The implant device of claim 1, wherein the flexible sleeve
abuts the anchor creating contiguous outside threads along the
anchor and the flexible sleeve.
11. The implant device of claim 1, wherein the first coiled fiber
and the second coiled fiber are interwoven such that the first
coiled fiber engages outside the second coiled fiber, wherein each
coil of the first coiled fiber functions as a thread and each coil
of the second coiled fiber separates each of the coils of the first
coiled fiber.
12. The implant device of claim 1, wherein the cap includes
internal threads which mate with the external threads of the
flexible sleeve, wherein the cap further comprises a threaded
external distal portion which mates with the first bone portion as
a screw interface, and wherein the cap is configured to receive the
flexible sleeve such that the cap is configured to slide distally
along a length of the flexible sleeve, wherein the cap is
configured to engage the flexible sleeve such that the sleeve is at
least partially restricted from moving distally relative to the
cap.
13. The implant device of claim 1, wherein the flexible sleeve
further comprises a proximal end that is hexagonal in shape and
configured to receive a hexagonal driver.
14. The implant device of claim 1, wherein the flexible sleeve is
configured to receive a force in a proximal direction and be placed
in tension to force the first bone portion towards the second bone
portion.
15. The implant device of claim 1, wherein the flexible sleeve is
comprised of an interwoven first coiled fiber and second coiled
fiber.
16. The implant device of claim 1, wherein a proximal portion of
the bone canal is larger such that the flexible sleeve does not
engage the proximal portion of the bone canal.
17. The implant device of claim 1, wherein the flexible sleeve is
cannulated.
18. The implant device of claim 1, wherein posts engage the
flexible sleeve from a perpendicular direction.
19. A method for treating a fracture of a bone, the method
comprising: inserting a lagwire system into the bone, wherein the
lagwire system comprises an anchor and a wire; wherein the wire has
a first end and a second end, wherein the anchor is attached to the
first end of the wire, wherein the anchor includes anchor threads;
wherein a cap is attached to the second end of the wire; cutting
the second end of the wire to a particular length; fixedly
attaching the anchor to a first bone portion; sliding a flexible
sleeve longitudinally over the wire such that the wire is
reciprocally received by the flexible sleeve, after the anchor is
fixedly attached to the first bone portion, wherein the flexible
sleeve has a first sleeve end and a second sleeve end, inserting
the flexible sleeve into a bone canal that spans across the
fracture between the first bone portion and a second bone portion;
threading the outer thread of the sleeve into at least a portion of
the bone canal and providing friction against at least a portion of
the bone canal; engaging the flexible sleeve to the anchor to
fixedly attach the flexible sleeve to the anchor, after the anchor
is fixedly attached to a first bone portion; wherein the anchor is
configured to receive the first sleeve end, such that the anchor
threads and the outer threads are contiguous, and wherein threads
on the cap and the outer threads on the second sleeve end are
continguous.
20. The method of claim 19, wherein the anchor includes tapered
threads behind cutting threads, such that the tapered threads are
configured to cut into the first sleeve end to secure the first
sleeve end to the anchor.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of, claims priority to
and the benefit of, U.S. Ser. No. 13/118,871 filed on May 31, 2011,
and entitled "LAGWIRE SYSTEM AND METHOD FOR THE FIXATION OF BONE
FRACTURES." The '871 application is a continuation-in-part of,
claims priority to and the benefit of, U.S. Ser. No. 12/898,975
filed on Oct. 6, 2010, and entitled "LAGWIRE SYSTEM AND METHOD FOR
THE FIXATION OF BONE FRACTURES. The '975 application is a
continuation-in-part of, claims priority to and the benefit of,
U.S. Ser. No. 12/860,122 filed on Aug. 20, 2010, and entitled
"LAGWIRE SYSTEM AND METHOD FOR THE FIXATION OF BONE FRACTURES." The
'122 application is a continuation-in-part of, claims priority to
and the benefit of, U.S. Ser. No. 12/491,132 filed on Jun. 24,
2009, and entitled "FILAMENT AND CAP SYSTEMS AND METHODS FOR THE
FIXATION OF BONE FRACTURES." The '132 application is a
continuation-in-part of, claims priority to and the benefit of,
U.S. Ser. No. 12/265,890 filed on Nov. 6, 2008, and entitled
"SYSTEM AND METHOD FOR THE FIXATION OF BONE FRACTURES." The '890
application is a continuation-in-part of, claims priority to and
the benefit of, U.S. Ser. No. 12/235,405 filed on Sep. 22, 2008,
and entitled "SYSTEM AND METHOD FOR THE FIXATION OF BONE
FRACTURES." The '405 application is a continuation-in-part of,
claims priority to and the benefit of, U.S. Ser. No. 11/952,715
filed on Dec. 7, 2007, and entitled "BONE SCREW SYSTEM AND METHOD"
(now U.S. Pat. No. 8,828,067, issued on Sep. 9, 2014). The '067
patent is a continuation-in-part of, claims priority to and the
benefit of, U.S. Ser. No. 11/742,457 filed on Apr. 30, 2007, and
entitled "BONE SCREW SYSTEM AND METHOD" (now U.S. Pat. No.
8,702,768, issued on Apr. 22, 2014). The '768 patent is a
continuation-in-part of, claims priority to and the benefit of,
U.S. Ser. No. 11/678,473 filed on Feb. 23, 2007, and entitled
"CANNULATED BONE SCREW SYSTEM AND METHOD" (now U.S. Pat. No.
8,679,167, issued Mar. 25, 2014). The '167 patent is a
continuation-in-part of, claims priority to and the benefit of,
U.S. Ser. No. 10/779,892 filed on Feb. 17, 2004, and entitled
"SYSTEM AND METHOD FOR THE FIXATION OF BONE FRACTURES" (now U.S.
Pat. No. 7,591,823, issued on Sep. 22, 2009). The '823 patent is a
continuation-in-part of, claims priority to and the benefit of,
U.S. Ser. No. 10/272,773 filed on Oct. 17, 2002, and entitled
"SYSTEM AND METHOD FOR THE FIXATION OF BONE FRACTURES" (now U.S.
Pat. No. 6,736,819, issued on May 18, 2004). The '819 patent is the
non-provisional application of, claims priority to and the benefit
of, U.S. Provisional Application Ser. No. 60/330,187 filed on Oct.
18, 2001, and entitled "LAGWIRE SYSTEM AND METHOD." All of which
are incorporated herein by reference in their entirety.
FIELD OF INVENTION
[0002] This disclosure generally relates to the fixation of
fractures in one or more objects, and more particularly, to an
improved system and method for the fixation of bone fractures that
is operable for use without the need for guide wires.
BACKGROUND OF THE INVENTION
[0003] It is well-known in the medical arts that constant pressure
on a bone fracture speeds healing. As such, orthopedic physicians
may use a lagwire device to connect the bone portions and exert
constant pressure on the bone fracture.
[0004] Once the lagwire is inserted into the bone fragments, it is
frequently desirable to provide additional support to the wire to
promote healing. Moreover, in some situations, it may be desirable
for the lagwire system to allow at least some movement of the bone
fragments relative to each other to promote healing, as well as be
able to deliver treatments or to serve as treatment to the damaged
area.
[0005] As such, a need exists for a lagwire system that: (1)
provides the lagwire with additional strengthening support; (2)
permits some movement of the first bone portion relative to the
second bone portion; and/or (3) provides treatment to the bone
portions to improve healing.
SUMMARY OF THE INVENTION
[0006] In general, the system facilitates the fixation of bone
fractures. In an exemplary embodiment, the lagwire system includes
an anchor component (e.g., reamer), a wire, and a sleeve. The
sleeve is operable to enter a canal in a bone prepared by the
anchor and wire. The sleeve may be attached to the anchor upon
entry into the bone. The sleeve may include multiple coiled
elements interwoven together. The canal may extend across a bone
fracture allowing the sleeve to provide support across the bone
fracture. A cap may also be incorporated to restrict forward and
backward movement of the sleeve relative to the canal.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] A more complete understanding may be derived by referring to
the detailed description and claims when considered in connection
with the figures, wherein like reference numbers refer to similar
elements throughout the figures, and:
[0008] FIG. 1A is a lagwire system including an anchor component
and wire in accordance with an exemplary embodiment.
[0009] FIG. 1B is a lagwire system illustrating various thread
combinations as embodiments.
[0010] FIG. 1C illustrates an embodiment of an anchor component
having an improved tip geometry in accordance with an exemplary
embodiment.
[0011] FIGS. 1D and 1E illustrate an embodiment of a lagwire system
comprising a flexible wire and an anchor component having an
improved tip geometry in accordance with an exemplary
embodiment.
[0012] FIG. 1F illustrates an exemplary lagwire system navigating
through a bone canal in accordance with an exemplary
embodiment.
[0013] FIGS. 1G and 1H illustrate exemplary embodiments of a sleeve
used in connection with a lagwire system.
[0014] FIGS. 1I and 1J illustrate exemplary embodiments of a
sleeve.
[0015] FIGS. 1K and 1L illustrate exemplary embodiments of a sleeve
comprising a "Christmas Tree" configuration.
[0016] FIG. 1M illustrates an exemplary embodiment of a lagwire
device comprising an anchor component, a threaded sleeve, a tubular
sleeve, and a cap.
[0017] FIG. 1N illustrates an exemplary embodiment of an anchor
component and threaded sleeve.
[0018] FIG. 1O illustrates an exemplary embodiment of a cap.
[0019] FIG. 1P illustrates an exemplary embodiment of the anchor
component, threaded sleeve, tubular sleeve and cap of a lagwire
system.
[0020] FIG. 1Q illustrates an exemplary method of using the lagwire
system to deliver treatment to a desired location.
[0021] FIG. 1R illustrates an exemplary embodiment of a lagwire
system comprising eyelets to facilitate coupling of a treatment to
the lagwire.
[0022] FIG. 2A is a quick cap in accordance with an exemplary
embodiment.
[0023] FIG. 2B is an alternative embodiment of a quick cap in
accordance with an exemplary embodiment.
[0024] FIG. 2C is a screw cap in accordance with an exemplary
embodiment.
[0025] FIG. 2D is a flat cap in accordance with an exemplary
embodiment.
[0026] FIG. 2E is a top view of an alternative embodiment of a cap
in accordance with an exemplary embodiment.
[0027] FIG. 2F is a perspective view of another embodiment of a cap
in accordance with an exemplary embodiment.
[0028] FIG. 2G is a top view of an exemplary spring in accordance
with an exemplary embodiment.
[0029] FIG. 2H is an exploded perspective view a cap in accordance
with an exemplary embodiment.
[0030] FIG. 2I is a perspective view of the embodiment of the cap
of FIG. 2H, fully assembled.
[0031] FIG. 2J is a cross section view of the embodiment of the cap
shown in FIG. 2I.
[0032] FIG. 2K is a perspective view of an exemplary embodiment of
the cap.
[0033] FIG. 2L is a cross section view of the cap shown in FIG.
2K.
[0034] FIG. 2M is an exploded view of an exemplary embodiment of
the lagwire device.
[0035] FIG. 2N is a cross section view of an exemplary embodiment
of the lagwire device.
[0036] FIG. 2O is an exemplary embodiment of the lagwire
device.
[0037] FIG. 2P is an exemplary embodiment of a lagwire device.
[0038] FIG. 2Q is an exemplary embodiment of a lagwire device
without a cap.
[0039] FIG. 2R is an exemplary embodiment of a threaded lagwire
tip.
[0040] FIG. 2T is an exemplary embodiment of an tool receiving end
of a threaded sleeve.
[0041] FIG. 2U is an exemplary embodiment of a lagwire device
having a threaded cap and sleeve.
[0042] FIG. 2V is an exemplary embodiment of the lagwire head of
2U.
[0043] FIG. 2W is an exemplary embodiment of the driver surface of
the sleeve of 2U.
[0044] FIG. 2X is an exploded view of the lagwire device.
[0045] FIG. 2Y is an assembled view of the lagwire device of FIG.
2X.
[0046] FIG. 2Z.1 is an exemplary embodiment of components of a
sleeve shown separately.
[0047] FIG. 2Z.2 is an exemplary embodiment of interwoven
components of a sleeve having four fibers.
[0048] FIG. 2Z.3 is an exemplary embodiment of interwoven
components of a sleeve having six fibers.
[0049] FIG. 2Z.4 is an enlarged exemplary embodiment a sleeve
having six fibers.
[0050] FIG. 2Z.5 is an exemplary embodiment of an end view of a
sleeve having six fibers.
[0051] FIG. 3A is a tensioner in accordance with an exemplary
embodiment.
[0052] FIG. 3B is another embodiment of a tensioner in accordance
with an exemplary embodiment.
[0053] FIG. 4A is a fixation of a bone fracture in accordance with
an exemplary embodiment.
[0054] FIGS. 4B-4D are fixations of fractures of a certain portions
of a bone in accordance with an exemplary embodiment.
[0055] FIG. 4E is a fixation of a bone fracture by inserting the
lagwire through the entire limb to facilitate attaching an external
fixation device to the limb in accordance with an exemplary
embodiment.
[0056] FIGS. 4F-4G is a fixation of a bone fracture by inserting
the lagwire through the entire limb to facilitate holding a plate
to the bone to help fix certain types of fractures in accordance
with an exemplary embodiment.
[0057] FIG. 4H is a fixation of a spinal injury in accordance with
an exemplary embodiment.
[0058] FIG. 5A is an exemplary head of the extractor of FIG. 5B in
accordance with an exemplary embodiment.
[0059] FIG. 5B is an exemplary extractor in accordance with an
exemplary embodiment.
[0060] FIG. 5C is another embodiment of an exemplary extractor in
accordance with an exemplary embodiment.
[0061] FIG. 6 is an exemplary cutter in accordance with an
exemplary embodiment.
DETAILED DESCRIPTION
[0062] The present disclosure includes various exemplary
embodiments in sufficient detail to enable those skilled in the art
to practice the inventions, and it should be understood that other
embodiments may be realized without departing from the spirit and
scope of the inventions. Thus, the following detailed description
is presented for purposes of illustration only, and not of
limitation, and the scope of the inventions is defined solely by
the appended claims. The particular implementations shown and
described herein are illustrative of the invention and its best
mode and are not intended to otherwise limit the scope in any
way.
[0063] In general, the present system facilitates the change in
distance between objects, object portions, or surfaces, compresses
objects or object portions together, and/or provides a configurable
or random amount of pressure between surfaces. The system may
facilitate changing, maintaining, reducing and/or expanding the
distance between objects or object portions. The applied pressure
may be suitably configured to be constant, increasing, decreasing,
variable, random, and/or the like. In an exemplary embodiment, the
system includes a device which may be fixedly or removably attached
to pathology, such as to a certain portion of a bone. In a
particular embodiment, the device is fixedly or removably attached
to the far cortex of the bone. In another embodiment, the
disclosure includes a device or method for retracting the attached
device to reduce the distance between the surfaces of the
pathology. In a further embodiment, the disclosure includes a
device and/or method for maintaining the pressure between the
surfaces of pathology. In various embodiments, the system is
configured to provide improved healing of a fracture and/or the
surrounding tissue.
[0064] In an exemplary embodiment, and as shown in FIGS. 1 and 2,
the lagwire system 1 includes a head or anchor component 2 (e.g.,
reamer), a wire 12 and a cap 20. The lagwire system 1 may be
fabricated using any type, amount or combination of materials
suitably configured for the particular application. In an exemplary
embodiment for medical applications, the lagwire system 1 is
fabricated with stainless steel, titanium and/or titanium alloy
which minimize reactivity with the body. Each component may be
fabricated with various diameters, thread pitches, lengths and/or
the like. The anchor component 2 may include threads, fins, tines,
or any other fixation device or structure capable of securing the
anchor component 2 to an object. Wire 12 may form any
cross-sectional shape, width, thickness, diameter, and surface
features along its length, and thus, for example, may form a simple
cylinder and/or may include ribs, threads, serrations, one or more
flat surfaces, bumps, and/or roughened surfaces along its length.
These and other various characteristics of lagwire system 1 enable
it to self guide through various soft tissues and bone.
[0065] Certain exemplary components of the system will now be
discussed. The anchor component 2 is any device which is configured
to fixedly or removably attach to any object, such as pathology. In
a particular embodiment, the anchor component 2 is configured to be
fixedly or removably attached to the far cortex of the bone, as
shown in FIGS. 4A-4G. As best shown in FIG. 1A, the anchor
component 2 may include, for example, a self drilling tip 4 device
which is suitably configured to puncture a hole and/or guide the
anchor component 2, self cutting threads 6 which are suitably
configured to cut thread grooves into the inside surface of a hole,
fastening threads 8 which are suitably configured to mate with the
newly formed thread grooves, and a tool attachment 10 suitably
configured for mating with a tool head (e.g., hex head wrench,
socket wrench, Phillips screwdriver, flathead screwdriver, allen
wrench and/or the like).
[0066] Anchor component 2 may include different and interchangeable
thread configurations, lengths, diameters, pitches and the like to
facilitate insertion into different types of bone or other
structures (e.g., cortical bone, cancellous bone, etc). Similarly,
cap 20 may include different thread configurations, lengths,
diameters, pitches and the like to facilitate insertion into
different types of bone or other structures. For example, both the
anchor component 2 and/or cap 20, may be interchangeably removed
and replaced by different anchor components 2 and caps 20 with
different thread configurations. Alternatively, the anchor
component 2 may not be removable from the remainder of the wire
12.
[0067] Examples of such thread configurations are illustrated in
FIG. 1B and may be adapted for insertion into various bone or other
structures. In one embodiment, the anchor component 2 includes
leading threads 280 accommodating insertion into cortical bone
while the cap 20 includes trailing threads 282 accommodating
insertion into cortical bone. In another embodiment, the anchor
component 2 includes leading threads 284 accommodating insertion
into cancellous bone while the cap 20 includes trailing threads 286
accommodating insertion into cancellous bone. In another
embodiment, the anchor component 2 includes leading threads 280
accommodating insertion into cortical bone while the cap 20
includes trailing threads 286 accommodating insertion into
cancellous bone. In another embodiment, the anchor component 2
includes leading threads 284 accommodating insertion into
cancellous bone while the cap 20 includes trailing threads 282
accommodating insertion into cortical bone. In another embodiment,
the anchor component 2 includes leading threads 280 accommodating
insertion into cortical bone while the cap 20 includes trailing
threads 288 accommodating insertion a mechanical component such as
a plate anchored into bone. In another embodiment, the anchor
component 2 includes leading threads 284 accommodating insertion
into cancellous bone while the cap 20 includes trailing threads 288
accommodating insertion a mechanical component such as a plate
anchored into bone. In another embodiment, the anchor component 2
includes leading threads 280 accommodating insertion into cortical
bone while the cap 20 includes a low-profile button-like design 290
that butts against the bone or a mechanical component. In another
embodiment, the anchor component 2 includes leading threads 284
accommodating insertion into cancellous bone while the cap 20
includes a low-profile button-like design 290 that butts against
the bone or a mechanical component. In another embodiment, the
anchor component 2 includes leading threads 280 accommodating
insertion into cortical bone while the cap 20 includes a
low-profile button-like design that butts against the bone or a
mechanical component and may also include spikes or teeth 292 to
prevent rotation of the cap 20. In another embodiment, the anchor
component 2 includes leading threads 284 accommodating insertion
into cancellous bone while the cap 20 includes a low-profile
button-like design that butts against the bone or a mechanical
component and may also include spikes or teeth 292 to prevent
rotation of the cap 20.
[0068] In an exemplary embodiment, the anchor component may
comprise any geometry that suitably allows the anchor component to
partially or fully move forward if exposed to material, such that
it will glance off (e.g., deflect off of or move away from) the
surrounding bone when traveling through a bone canal. Moreover, the
anchor component may be flexible or inflexible.
[0069] For example, FIG. 1C illustrates an embodiment of anchor
component 5 comprising tip 3 and cutting threads 8. As shown, tip 3
comprises a partially or fully substantially planar surface and
pointed cutting edge 7. However, it will be understood by one
skilled in the art that the tip and cutting edge may comprise any
desired gradient. For example, the tip and cutting edge may be
adjusted to be flatter or sharper depending upon various factors,
such as the strength of the bone and desired rate of advancement
through the canal. For example, if a patient's bones are brittle, a
flatter point angle may be used to avoid or minimize puncturing of
the bone.
[0070] Moreover, in one embodiment, the anchor component permits
forward movement of the device, but prevents or minimizes rearward
translation. For example, the shape of helical threads 8 may permit
forward movement, while restricting or minimizing rear
movement.
[0071] In another embodiment of a system 1, the cap 20 may be
placed at both ends of the wire 12, and any combination of caps 20
threads or additional features may be used as preferred by an
operator of the system 1. For example, in one embodiment, a first
cap 20 includes cortical threads 282, cancellous threads 286,
machine threads 288 accommodating insertion a mechanical component
such as a plate anchored into bone, a low-profile button-like
design 290 that butts against the bone or a mechanical component,
and/or spikes or teeth 292 to prevent rotation of the first cap 20;
and a second cap 20 includes cortical threads 282, cancellous
threads 286, machine threads 288 accommodating insertion a
mechanical component such as a plate anchored into bone, a
low-profile button-like design 290 that butts against the bone or a
mechanical component, and/or spikes or teeth 292 to prevent
rotation of the second cap 20.
[0072] In a particular embodiment, the tip is on the front end of
anchor component 2, followed by the cutting threads 6, the
fastening threads 8, the tool attachment 10, then wire 12. The
elements of anchor component 2 may be fabricated as one component
or one or more elements may be configured to be removably or
fixedly mated together to form anchor component 2. If mated
together, a particular element may be exchanged for different
applications. For example, if anchor component 2 needs to be
inserted into a dense or hard bone, a stronger or sharper tip 4 may
be screwed into thread element 6,8. Moreover, if deeper thread
grooves are desired, cutting threads 6 may be replaced with greater
diameter threads. Furthermore, if a different tool head is
incorporated into a drill, tool attachment 10 may be exchanged with
the appropriate attachment.
[0073] In one embodiment, the outside diameter of the fastening
threads are similar to the thread diameters of known surgical screw
sizes. Exemplary outside diameters of cortical anchor components
include 3.5 mm and 4.5 mm, wherein the length of the thread section
is similar to the cortex thickness. Exemplary outside diameters of
cancellous (i.e., little or no cortex) anchor components include
about 4.0 mm and 6.5 mm, wherein the length of the thread section
may be about 16 mm or 32 mm.
[0074] Wire 12 is any device suitably configured, when force is
applied, to reduce the distance between two surfaces. In one
embodiment, wire 12 is configured to retract the anchor component 2
device to reduce the distance between the surfaces of the
pathology. In one embodiment, anchor component 2 and wire 12 are
constructed as one component. In another embodiment, anchor
component 2 and wire 12 are constructed as separate components, but
the components are configured such that the anchor component 2 may
be threaded onto wire 12 after wire 12 is placed into the bone.
Wire 12 further includes an interface component 14 on at least a
portion of its surface, wherein the interface component 14 is
suitably configured to limit the movement of cap 20 to move
distally toward anchor component 2, but not proximally
(backwards).
[0075] In an exemplary embodiment, interface component 14 of wire
12 includes a sawtooth like configuration such that one side of
each tooth (e.g. the side closest to anchor component 2) is
substantially perpendicular to the surface of wire 12, while the
other side of the sawtooth is at a suitable angle, such as 45
degrees, thereby forming a triangular pattern for each sawtooth. In
this manner, the inverse sawtooth on the inside surface of the cap
slides or bends over the angled side of the wire sawtooth, but the
substantially perpendicular side of the wire sawtooth restricts or
limits the cap sawtooth from backwards movement. In another
embodiment, any portion or the entire length of wire 12 includes
any configuration such as, for example, round, oval, flat on one or
more portions of the wire, and/or microgrooves or ridges along the
wire (which may include the sawtooth configuration, indentions or
other configurations) to increase the friction along the wire. In
one embodiment, wire 12 holds 20 pounds of pull; however,
microgrooves in the wire may significantly increase the strength of
the wire 12.
[0076] In an exemplary embodiment, wire 12 is comprised of a thin
metal such as, for example, stainless steel, titanium and/or
titanium alloy, so it may be easily cut to almost any desired
length.
[0077] In one embodiment, the wire is flexible such that the wire
can be bent to navigate through an object, such as a bone canal.
FIGS. 1D and 1E illustrate different views of an exemplary
embodiment of lagwire system 11 comprising flexible wire 13 and
anchor component 5 (illustrated in FIG. 1C).
[0078] FIG. 1F illustrates use of an embodiment of a lagwire system
within a non-linear bone canal. As shown, flexible wire 13 is
operable to bend to allow the system to maneuver through both
linear and non-linear bone canals. The configuration of anchor
component 5 is operable to glance off the surrounding bone while
traveling through the bone canal, such that the anchor will not
break through and cause damage to the bone.
[0079] The lagwire system may be inserted into a bone using any
manual or automatic device that suitably rotates the anchor
component. Moreover, the lagwire system may be inserted with or
without a guide wire or other stabilizing device.
[0080] In various embodiments, the lagwire system comprises an
anchor component (e.g., reamer), one or more sleeves (such as
threaded sleeve and/or tubular sleeve), and a cap. For example,
FIGS. 1M-1P illustrate lagwire system 111 comprising reamer 109,
wire 171, threaded sleeve 108, tubular sleeve 141 and cap 143.
[0081] The tubular sleeve may be any structure operable for
insertion over the wire to provide additional stability to the
wire. For example, FIG. 1M illustrates an exemplary embodiment of
tubular sleeve 141 having a substantially smooth exterior surface
and a shape that substantially conforms to the shape of the lagwire
171 (i.e., cylindrical). However, it will be understood that the
sleeve may be any desired material, length, diameter, size and/or
shape (e.g., square, triangular, elliptical). In various
embodiments, the exterior surface of the tubular sleeve may
comprise one or more gripping means. The sleeve may be configured
with sufficient strength and shape that it may be inserted into a
previously (partially or fully) reamed bone canal without the
support of the wire (or with minimal support).
[0082] The threaded sleeve may be any structure having a gripping
component on an exterior and/or interior surface. A gripping
component may be any material, structure, device or shape that
increases the holding strength of the lagwire. For example, as
illustrated in FIG. 1M, threaded sleeve 108 has a gripping
component comprising a threaded surface. In various embodiments,
the gripping component may comprise threads, barbs, a ribbed
surface or any other gripping component which enhances holding
strength. Moreover, the gripping component may comprise any desired
configuration. For example, FIGS. 1K and 1L illustrate sleeve 192
comprising gripping component 193 having a "Christmas Tree"
configuration.
[0083] FIGS. 1G-1J illustrate exemplary embodiments of a threaded
sleeve 192 comprising threaded external surface 193. As shown in
FIG. 1G, threaded sleeve 192 may be positioned so as to abut anchor
component 2, and/or threaded sleeve 192 may comprise a component
for joining sleeve 192 to anchor component 2 (such as threads 193).
In other embodiments, threaded sleeve 192 may be positioned at any
desired location along the length of lagwire 12. Moreover, in some
embodiments, the sleeve may comprise a locking mechanism, such as
threads and/or the like, to affix the sleeve at a desired
position.
[0084] FIG. 1H illustrates threaded sleeve 192 having a tubular
configuration so as to be operable to slide along the length of
lagwire 12. In other embodiments, threaded sleeve 192 may be
integrally formed with lagwire 12.
[0085] As shown in FIG. 1M, tubular sleeve 141 abuts threaded
sleeve 108, and threaded sleeve 108 abuts reamer 109. However, it
will be understood that tubular sleeve 141 and threaded sleeve 108
may be positioned at any desired location along wire 171. For
example, in an embodiment, tubular sleeve 141 may be positioned so
as to bridge a bone fracture.
[0086] The threaded sleeve and tubular sleeve may partially or
fully comprise any suitable material, such as plastic (e.g.,
polyetherketone (PEEK)), steel, titanium, titanium alloy, and/or
the like, and may be flexible or inflexible. Moreover, these
materials may be incorporated onto or into any or all of the parts,
components, and/or devices discussed herein (e.g. wire, anchor,
cap, sleeve, etc.)
[0087] With continued reference to FIGS. 1M-1P, it will be
understood that any of reamer 109, threaded sleeve 108 and/or
tubular sleeve 141 may be separate components or may be integrally
formed together as one component. For example, the threaded sleeve
and the tubular sleeve may be formed as one component. It will also
be understood that threaded sleeve and tubular sleeve may be any
desired length. For example, as illustrated in FIG. 2P, a threaded
sleeve 1008 may extend the entire length of the wire between head
1009 and cap 1120. In another example, as illustrated in FIG. 2Q,
threaded sleeve 1008 may extend a portion of the length of wire
1071.
[0088] In various embodiments, head 1009 may be configured to
receive an end of threaded sleeve 1008 such that the threads
between head 1009 and threaded sleeve 1008 are suitably contiguous.
In another embodiment, threaded sleeve 1008 and cap 1120 may be
configured such that their threads are suitably contiguous when
abutted end to end. As illustrated in FIG. 2R, wire 1071 may mate
with head 1009 in a configuration that allows threaded sleeve 1008
to abut head 1009 creating suitably contiguous threads between head
1009 and threaded sleeve 1008.
[0089] In another embodiment, one or more ends 1010 of threaded
sleeve 1008 (and/or tubular sleeve 141) may have a surface
configured to receive a driver. For example, as illustrated in FIG.
2T, threaded sleeve 1008 may have a hexagonal end 1010 configured
to receive any of a variety of hexagonal drivers. In another
example, as illustrated in FIG. 2W, threaded sleeve 1008 may have
multiple arc lobes 1013 for receiving a driver. Any surface or
driver capable of providing suitable torque for driving the sleeve
may be incorporated.
[0090] In other embodiments, as shown in FIG. 2V, head 1009 may be
configured with tapered left handed threads 1012 behind cutting
threads 1011. The tapered left handed threads 1012 may cut into
sleeve 1008. By threading sleeve 1008 over lagwire 1071, sleeve
1008 can advance until it contacts head 1009. In contacting head
1009, tapered left handed threads 1012 may cut into sleeve 1008,
securing sleeve 1008 to lagwire 1071. The secured engagement
between head 1009 and sleeve 1008 allows a user to back both the
lagwire 1071 and sleeve 1008 out of a bone at the same time.
[0091] In accordance with one embodiment, threaded sleeve 1008 may
be used to fixate a fractured bone and aid in healing by drilling a
hole into at least two bone fragments. Sleeve 1008 is configured to
provide fixation of a fracture at specified lengths. Sleeve 1008 is
further configured to provide increased stabilization across the
fracture. In one embodiment, an operator may bore out the proximal
bone fragment (the fragment closest to the operator) such that
sleeve 1008 threads will not engage the walls of the hole.
Inserting lagwire 1071 and anchoring head 1009 into the distal bone
fragments such that applying a force on lagwire 1071 will compress
the bone fragments. The operator may compress the bone fragments
with lagwire 1071 and thread threaded sleeve 1008 over lagwire
1071. The operator may thread sleeve 1008 into the distal bone
portion to any desired distance.
[0092] In accordance with various embodiments, once the sleeve is
threaded, the operator may thread cap 1120 over sleeve 1008 until
cap 1120 contacts the exterior of the bone and/or another structure
such that sleeve 1008 cannot be pulled farther into the bone any
substantial distance, due to the bone fragments trying to separate.
In another embodiment, cap 1120 may be threaded onto sleeve 1008
before sleeve 1008 is inserted into the bore. In various
embodiments, the cap and sleeve may be configured to reduce the
bone facture and maintain reduction across the fractured bone
fragments. In various embodiments, sleeve 1008 and/or cap 1120
provides improved healing of the fracture and the surrounding
tissue.
[0093] In accordance with various embodiments, sleeve 1008 may aid
in securing a fracture without the support of the wire (or with
minimal support). As such, sleeve 1008 may be cannulated for
sliding over a wire as described in other embodiments or the sleeve
may be a solid wire made of PEEK or other biocompatible materials.
In such embodiments, the device will be referred to as a sleeve
while still respecting that in the various embodiments it may not
be cannulated but may be a solid wire. In various embodiments the
sleeve may have various distal tips which enable it to more easily
advance through a canal.
[0094] In one embodiment, an entry point is created in the bone. A
lagwire (i.e. the anchor and wire) is inserted into the entry point
and a canal is reamed through a center portion of the bone (see for
example FIG. 1F) and across a fracture in the bone (see for example
FIG. 4A-4C). As discussed in other embodiments tension may be
applied on the lagwire causing the gap at the fracture to be
decreased (e.g. lagging the fracture back together). With the
fracture reduced, the lagwire may be removed.
[0095] With reference to exemplary FIG. 2X and 2Y, and in
accordance with another embodiment, the lagwire may be used to ream
a canal in the bone with head 1009 and across the fracture but be
removed without reducing the fracture. After the canal has been
prepared, sleeve 1008 may be inserted into the canal. Sleeve 1008
may be advanced into the canal until the sleeve bridges the
fracture in the bone. In various embodiments, the sleeve may have a
distal thread 1014 and/or the sleeve may have a proximal thread
1015. In various embodiments, the sleeve may be fully or partially
threaded (as previously discussed). The threads allow the sleeve to
be threaded into and engage the canal through either a partial
length or the entire length of the sleeve. Distal threads 1014 may
allow the distal end of the sleeve to be threaded into a distal
bone fragment. The proximal end of the sleeve may be retained in
the proximal bone fragment using proximal threads 1015.
[0096] In various embodiments, the sleeve may be attached to the
anchor and sent down a prepared canal as one piece. The sleeve and
the lagwire may be used in concert to bridge and/or reduce the bone
fracture. In one example, the attachment between the sleeve and the
anchor may be a weld. However, the attachment between the sleeve
and the anchor may be accomplished in any manner known in the art,
such using one or more of adhesive, mechanical attachment (e.g.
threaded together, interference fit, etc.), fasteners, etc.
[0097] In another embodiment, the proximal bone portion may be over
reamed, such that sleeve 1008 does not engage the canal in the
proximal and consequently sleeve 1008's movement is not restricted
by the canal. However, the sleeve engages in (and the sleeve's
movement is restricted by) the distal bone portion where the canal
is not over reamed. The sleeve may then be placed in tension by
applying a force on the sleeve in the proximal direction, thereby
forcing the distal bone portion towards the proximal bone portion.
Cap 1120 may then be threaded over the sleeve (e.g., into the
canal) in the proximal bone portion. Cap 1120 interior threads may
engage sleeve 1008 and cap 1120 outer threads may engage the canal.
With the distal portion of the sleeve retained in the distal bone
portion and the proximal portion of the sleeve retained in the
proximal bone portion by cap 1120, the sleeve tension may be fully
or partially maintained.
[0098] In various other embodiments, the sleeve may be smooth,
threaded, and/or have any surface features, composition or
textures. Furthermore, the sleeve may be held in the various bone
fragments by other devices engaging the sleeve from a perpendicular
direction, after it has been inserted into the various bone
portions. For example, posts may be attached to the sides of the
sleeve. In one embodiment, ultrasonic welding may be utilized to
hold the posts in the side of the sleeve. In accordance with
various embodiments, ultrasonic welding may be utilized on any
component described herein to fasten other components, devices or
features thereto.
[0099] With reference to exemplary FIG. 2Z.1-5 and in accordance
with another embodiment, sleeve 1008 may comprise one or more
coiled and/or helical fibers. Such a configuration may also be
referred to as hollow helical spring sleeve. For example, as
illustrated in exemplary FIG. 2Z.1 and 2Z.2, four fibers 1111,
1112, 1113, and 1114 may be interwoven to form sleeve 1008. In one
example, the fibers may be interwoven such that each individual
coil from each fiber is separated by coils from other interwoven
fibers, as shown in FIG. 2Z where one coil is fiber 1111, then the
next adjacent coil may be fiber 1113, then the next adjacent coil
may be fiber 1112, and the next adjacent coil may be fiber 1114.
While in the illustrated example four fibers are used, in various
other embodiments, any number of fibers can be used, such as a
single coil, two entwined coils, three entwined coils, etc. For
example, with reference to exemplary FIG. 2Z.3-2Z.5 six fibers may
be incorporated in to the sleeve. In this example additional fibers
1115 and 1116 are incorporated.
[0100] In another embodiment, the interwoven fibers may comprise
multiple layers. For example, four fibers may be woven as indicated
above forming a first layer and another set of four fibers with a
larger diameter coil may be interwoven over the first layer. In may
be noted that any number of fibers and or layers may be
incorporated in the weaving process.
[0101] In accordance with various embodiments, each fiber may have
different a cross section, size and/or shape. In one example, the
fibers may have a shape that is square cross section. Or in another
example, in a sleeve wherein two fibers form the sleeve, one fiber
may have a small diameter and the other fiber may have a larger
diameter. (see, for example, fiber 1111 in FIG. 2Z compared to
fiber 1112 in FIG. 2Z). When interweaving the two fibers, the
larger diameter cross section may extend outward with the smaller
diameter cross section coils separating the larger diameter coils.
One effect is a solid sleeve with the appearance of threads formed
by the large cross section coils. In one example, the outer
diameter of the larger coil may be about 4 mm, and the outer
diameter of the smaller coil may be about 3.5 mm. Whereas, the
fiber of the larger coil may be about 0.8 mm and the fiber diameter
of the smaller coil may be 0.6 mm.
[0102] In accordance with various embodiments, the shape of the
fiber cross sections can be designed to match a thread profile on
any surface on the outside of the coil/helix. The fiber cross
section may be further configured such that the surface between
each of the coils of each fiber is optimized to securely nest
and/or contact with the coils from other fibers which are
interwoven together. For example, a first fiber with a large cross
section may have two angled surfaces on the outside of the coil
which matches a thread profile. The first fiber may have a thread
like edge that is always maintained at a normal direction to the
coil rotation That is, a thread edge that is pointing out from the
axis of rotation to produce a consistent thread pitch and shape. In
various embodiments, a second fiber may have a flat surface on the
outside of the coil, but have a top and bottom surface configured
to mate with and/or engage with the larger cross section of the
coil on the first fiber, allowing the two fibers to be interwoven
creating a substantially solid single sleeve.
[0103] In various embodiments, the threads of the sleeve may be
controlled by the number and diameter of the fibers. For example,
six fibers may be incorporated in to the sleeve. In various
examples three fibers may be a first diameter and/or cross section
and three fibers may be a second diameter and/or cross section. In
various other examples, the sleeve may include two fibers of a
first diameter (which may be larger) and four fibers of a second
diameter which (which may be smaller.) This may produce a thread
with the same pitch, however it would have an effective thread
profile of twice the width.
[0104] In accordance with various embodiments, fibers may be
constructed from a variety of materials such as stainless steel,
aluminum, PEEK titanium, nitinol and/or other biocompatible
materials. In accordance with various embodiments, the fibers may
be commonly acquired structures such as springs. For example
springs of different cross sections may be threaded together to
form the sleeve. In accordance with various embodiments, a
manufacturing method of the sleeve may comprise wrapping the fibers
around a constant diameter mandrel that acts as the core of the
coil. The coil may then be slipped off the mandrel and finished. In
accordance with various embodiments, coils may be produced by high
speed fine machining of tube material. The cutters may break
through the tube into the center area and free the fibers to
move.
[0105] In accordance with one exemplary embodiment, a lagwire
system may be used to deliver treatment to a desired location. The
treatment delivered by the lagwire system may comprise any
composition, device or structure that will facilitate the fixation
and/or provide support to bones. For example, the treatment may
comprise medications (such as bone growth stimulation drugs or
structures), adhesives, implants, fasteners, ligaments, tendons,
and suturing materials. In one embodiment, a bondable material may
be delivered to the bone to facilitate the joining of bone
fragments. For example, the materials disclosed in U.S. Pat. Reg.
No. 7,217,290 entitled "SURGICAL DEVICES CONTAINING A HEAT BONDABLE
MATERIAL WITH A THERAPEUTIC AGENT," (the '290 Patent) which is
herein incorporated by reference in its entirety, may be delivered
to a region of interest using the lagwire system disclosed
herein.
[0106] A desired location may be any position on or within one or
more bones. It will be understood that the present system and
method may be used in connection with any type of bone, such as a
clavicle, pelvis, humerus, tibia, ulna, and/or the like.
[0107] In one embodiment, a lagwire system may be used to deliver
treatment to the interior of a bone. For example, the lagwire
system may be used deliver treatment via an intermedullary
canal.
[0108] As shown in FIG. 1Q, an exemplary method 1000 may comprise
the steps of: creating an entry point into the bone using the
lagwire system (this may be accomplished manually or under power)
(Step 1010), attaching the treatment to the lagwire (1020),
inserting the lagwire into the bone, such as through the
intermedullary canal, to a desired position (Step 1030). Method
1000 may also include the step of removing the lagwire and allowing
the treatment to remain at the desired position (1040). In other
embodiments, the lagwire may be left within the bone. In some
embodiments, an optimal entry point for the lagwire is selected
based upon the unique size and shape of the bone. As discussed
herein, the lagwire may be suitably flexible to permit the device
to travel through linear or non-linear canals.
[0109] In one embodiment, the treatment (such as liquid and/or gel
medication) may be delivered through the center of the tubular or
threaded sleeve. In another embodiment, the sleeve may be the
treatment itself In another embodiment, the wire and/or sleeve may
transport and/or deliver the treatment to the targeted
location.
[0110] In various embodiments, the lagwire, sleeve, and/or cap may
be used to transmit various frequencies of vibrations to targeted
portions of the bone to stimulate or otherwise influence bone
growth. In one example the vibrations may be ultrasonic.
[0111] The treatment may be attached to the lagwire in any number
of ways. In one embodiment, the treatment may be configured as a
sleeve that can be inserted over the lagwire. For example, a sleeve
comprising a heat-bondable material, such as PEEK or a material
disclosed in the '290 Patent, may be delivered to a region of
interest using the lagwire system. Treatment material may also be
inserted into the bone at various locations and angles so as to
contact the sleeve comprised of the treatment material located
within the canal. Heat or other activating means may then be
applied to join the treatment material, thereby creating additional
support for the bone.
[0112] In various embodiments, a lagwire system which permits
movement of the first object relative to the object during
treatment may be desirable. For example, in anterior cruciate
ligament (ACL) repair, it may be desirable to allow movement of the
femur relative to the tibia to permit the knee to function
normally. As such, in various exemplary embodiments, the lagwire
system may comprise a filament portion which permits movement of a
first bone portion relative to a second bone portion. The filament
may be any material that permits the desired amount of movement and
flexibility. For example, the filament may be one or more of
fasteners, ligaments, tendons, and suturing materials (including
natural and synthetic structures thereof). Moreover, the filament
may be substantially flexible or inflexible and may comprise single
or multi-thread materials.
[0113] For example, as illustrated in FIG. 1R, lagwire 12 may
comprise eyelets 190 suitable to couple filament 199 (shown herein
as a suture thread), to lagwire 12. The eyelets may be located at
any position in the lagwire system and the filament may be any
desired length. Although the attachment means is illustrated herein
as eyelets, it will be understood that the attachment means may
comprise any device, structure or component suitable to attach the
filament to the lagwire.
[0114] An exemplary method includes: providing a lagwire system
comprising: (a) an anchor component having a planar surface,
threads and a cutting surface having a pointed angle connected to a
flexible wire having a filament; (b) inserting the anchor component
into a first object using an automatic or manual rotating device,
such as a drill; (c) maneuvering the lagwire system through the
first object; and, (d) anchoring the anchor component into a second
object. The method may further comprise inserting a flexible or
inflexible tubular sleeve over the flexible wire.
[0115] Cap 20 is any device suitably configured to maintain or
increase the pressure between the surfaces of pathology by limiting
wire 12 movement. As shown in FIGS. 2A-2E, exemplary caps 20 may
include various configurations, materials, shapes and/or sizes. In
one embodiment, and as shown in FIG. 2A, cap 20 includes an inverse
interface component 22 relative to wire 12 interface component such
that cap 20 is restricted from backwards translation after cap 20
is inserted over wire 12. In one embodiment, the interface
component 22 on cap 20 is located at least on the inside surface of
the cap and includes a saw tooth pattern with the same or similar
pitch as the saw tooth on wire 12. This configuration also allows
cap 20 to slide along wire 12 without the need for spinning cap 20
which is important because time is of the essence in a medical
procedure and spinning the cap down a sufficiently long length of
wire would be very time-consuming. Examples of cap 20 include a
screw cap 20, flat cap 20 and a quick cap 20. As shown in FIG. 2C,
screw cap 20 is configured with teeth 22, cutting threads 24 and/or
mating threads 26 on the outside surface to facilitate rotating cap
20 into the cortex to, for example, fix surgical plates against
certain pathology. However, cutting threads 24 may not be needed on
any of the caps because cutting threads 6 of anchor component 2 may
have already tapped the threads on the inside surface of the bone,
so the teeth 22 or mating threads 26 alone can simply rotatably
engage the threads formed from cutting threads 6 and provide
sufficient friction to secure the cap in the bone. As shown in FIG.
2D, flat cap 20 may include teeth 22, cutting threads 24 and/or
mating threads 26 on the outside surface to facilitate rotating cap
20 into the cortex, but it also is configured with a flat top
surface 28 to allow cap 20 to be inserted into the cortex such that
the flat top surface 28 of cap 20 does not substantially protrude
from the cortex surface. As best shown in FIG. 2A, for example, the
quick cap 20 or any other cap may be configured with only the
interface component on the inside surface, thereby allowing for
quick and easy assembly.
[0116] With reference to FIG. 2E, in one embodiment, cap 20 is
configured as a planar disk 30 with a center hole 32, wherein the
center hole 32 includes an interface component 34 on its inner
circumference surface. In an exemplary embodiment, the pitch of the
saw tooth interface component is about 0.25 mm-0.5 mm. The planar
disk 30 may also include any configuration for facilitating
expansion of the disk 36 while sliding down wire 12. The
configurations may include, for example, a cut 38 or a hole 36 in
the planar disk 30. The planar disk may include multiple holes or
cuts spaced over the planar surface. One or more of the additional
holes 36 may also be connected to a cut 38 in the planar surface
that extends to the center hole 32. One or more of the holes 36 may
also be connected to a cut 40 in the planar surface that extends to
the outside edge of the planar surface. In one embodiment, six
additional holes 36 are evenly spaced around the planar surface
with each hole 36 connected to a cut 38 which extends to the center
hole, while one hole 36 also includes a cut 40 that extends to the
outside edge of the planar surface.
[0117] The planar disk may also set inside a shallow cup device,
wherein the circumference of the cup is slightly larger than the
circumference of the planar ring in order to allow expansion of the
ring. Moreover, a spring, or any other device suitably configured
to apply pressure to cap 20, is placed between the planar ring and
the cup device. In one embodiment, a bellville spring is used to
apply pressure to the cap 20. The spring is configured to provide
force on wire 12 after resorption. During the healing process,
cartilage forms at the fracture and the cartilage compresses, so
bone resorption typically occurs at the location of the fracture.
When force on the lagwire is released due to bone resorption during
healing, in one embodiment, cap 20 allows for auto tightening of
the lagwire because micro-motions or vibrations will often cause
cap interface device 22 to click down another notch on the inverse
interface device of the wire 12.
[0118] Another embodiment of a cap 20 is shown in FIG. 2F. As
discussed above, cap 20 fits over one end of wire 12, such that cap
20 permits travel of cap 20 in one direction (e.g., distal travel
with respect to the wire, toward the bone), but resists travel of
cap 20 in the other direction (e.g., proximal travel with respect
to the wire, away from the bone). In exemplary embodiments, cap 20
includes cutting threads 26, cover 70, a spring 80 and
substantially flat surfaces 76 around the circumference of cap 20
to facilitate griping and/or turning cap 20. Cap 20 may be
configured with a wider upper section which includes flat surfaces
76 around its circumference, and a tapered lower section with a
gradually reducing diameter. Cutting threads 26 extend from the
lower section. Cap 20 may include different thread configurations,
lengths, diameters, pitches and the like to facilitate insertion
into different types of bone or other structures (e.g., cortical
bone, cancellous bone, etc). Cover 70 may be integral with cap 20,
or may be a separate component which is permanently or temporarily
set in, or affixed to, cap 20. In one embodiment, cover 70 includes
an opening 72 (e.g., in center of cover 70) which receives wire 12
and an inlet 74 which is configured to receive a component of
extractor tool 90. Other embodiments of caps are disclosed in U.S.
application Ser. No. 11/952,413, filed on Dec. 7, 2007 and entitled
"SYSTEM AND METHOD FOR A CAP USED IN THE FIXATION OF BONE
FRACTURES," which is herein incorporated by reference in its
entirety.
[0119] In one embodiment, tension spring 80 is set inside cap 20.
In one embodiment, and with reference to FIG. 2G, tension spring 20
sits within cap 20 below cover 70; is circular; includes opening 84
(e.g., in center of circular ring) which receives wire 12; includes
an outer ring 82 and an inner ring 83; includes a cut into, or
non-connecting portion 86 of, outer ring 82 and/or inner ring 83;
and/or includes a tab 88 which extends outward from outer ring 82.
Outer ring 82 and an inner ring 83 may be one integrated ring, or
two or more separate rings, which may not be connected, or may be
connected in any manner.
[0120] At least a portion of inner ring 83 (or any portion of inner
circumference of tension spring 80) provides greater friction
against wire 12 one way (e.g., when the cap is pulled proximal,
away from the bone). The friction is asserted against wire 12
because cover 70 impacts tab 88, so tab 88 forces tension spring 80
to flex, torque and/or tilt (e.g., 15 degrees) opening 84, thereby
causing at least a portion of inner ring 83 to assert friction
against at least a portion of wire 12. When cap 20 is pushed the
other way (e.g., when the cap is pushed distal, toward the bone,
using extractor 90), tab 88 is forced away from cover 70 and does
not tilt, so it does not engage any surface, and the wire is able
to translate, with minimal or no friction, through the central
opening in the tension spring.
[0121] Another embodiment of a cap 20 is shown in FIGS. 2H, 2I, and
2J. FIG. 2H shows and exploded view of an example of the cap 20
with a cover or recessed nut 70, an angle or lever clutch 300, a
tension spring 80, and a body 302. When assembled, as shown in the
perspective view of FIG. 21 or cross section view of 2J, the
tension spring 80 resides within a chamber of the body 302, between
the body 302 and the cover 70. The locking lever clutch 70 also
resides between the body 302 and the cover 70, and is in movable
contact with the spring 80. The spring 80 is a flat spring washer
that applies a preloaded force to the lever clutch 300, biasing the
lever clutch 300 to skew to a plane that is not parallel with the
plane of the spring 80. In its skewed state, the lever clutch 300
includes defines a hole 304 along a central axis 306 that is not
coaxial with a central axis 308 of the cap 20, and frictional edges
310 defining a portion of the hole 304 are forced into frictional
contact with one or more flat or rounded outer surfaces of a wire
12 running along the axis 308 of the cap.
[0122] The tension spring 80 may, for example, be formed of a
relatively thin layer of nitinol or another resilient material. The
lever clutch 300 may, for example, be formed of a thicker layer of
stainless steel or titanium. The relatively thin layer of the
tension spring 80 occupies minimal space within the chamber of the
body 302, minimizing the overall size of the cap 20. The relatively
thick layer of the lever clutch 300 provides greater surface area
and strength to maximize stable and strong frictional contact and
lock between the frictional edges 310 and the outer surface of the
wire 12. In an exemplary embodiment, the lever clutch 300 and
spring 80 are either attached to each other or formed as a single
structure and may be formed of identical or varying materials and
thicknesses.
[0123] The frictional edges 310 permit distal movement of the cap
20 with respect to the wire 12 as the wire 12 moves through the
central axis 308 of the cap 20 and forces or biases the locking
lever clutch 300 to move upwards towards the cover 70, towards a
plane that is closer to parallel with the plane of the spring 80,
and in an orientation that permits the body of the wire 12 to move
through the hole 304 with less frictional contact against the
frictional edges 310. In contrast, the frictional edges 310 resist
proximal movement of the cap 20 with respect to the wire 12 as the
wire 12 moves through the central axis 308 of the cap 20 and forces
or biases the locking lever clutch 300 to move downwards away from
the cover 70, towards a plane that is closer to perpendicular with
the plane of the spring 80, and in an orientation that resists
movement of the body of the wire 12 through the hole 304 as the
frictional edges 310 are forced against and in increasing
frictional contact with the outer surface of the body of the wire
12.
[0124] The embodiment of a cap 20 described with reference to FIGS.
2H, 2I, and 2J can be unlocked during or after initial implantation
to make adjustments to, replace, or remove any or all of the system
1. To unlock the lever clutch 300 of the cap 20, a user may
manually, or by means of a special hook-like tool, raise a handle
312 of the clutch 300, for example, by exerting force on a lower
edge 314 of the handle 312 in a direction that releases the
friction edges 310 from their locking position with respect to the
outer surface of the wire 12.
[0125] In some situations, it may be desirable to prevent the first
and second bone portions from separating as well as further
compressing during treatment. For example, if the bone is brittle,
angled or contoured, further compression may damage the bone
fragments and impede recovery. As such, in various embodiments, a
cap may be any device which is operable to lock onto the wire so as
to prevent further backward or forward translation of the cap
relative to the wire. For example, the interior of the cap may
comprise one or more protrusions (e.g. teeth and/or fingers) or
other means operable to clamp, crimp and/or squeeze the wire to
prevent further movement relative to the cap. In an embodiment, the
interior of the cap is tapered such that when the cap is advanced
along the wire, the tapered portion clamps down on (or squeezes)
the wire until further movement of the cap is impeded. The cap may
also include slits or cut-out areas which allow the surface of the
cap to flex or bend.
[0126] In another embodiment, the cap may be configured to prevent
the sleeve or wire from backing out of the bone, without the cap
locking onto the wire or support sleeve. Referring to FIG. 2L, in
an exemplary embodiment, the cap 20 comprises threads 26 and a
blind hole 322 wherein blind hole 322 is sized to receive the wire
171 and/or the supporting sleeve 141. As an example, blind hole 322
can be a concave cavity or opening, specific depth hole, or a hole
with other features such as a counterbore. In this embodiment, the
cap may not have a through hole. Therefore, the wire and support
sleeve may not pass through the cap. Instead, the cap may be
configured to prevent the wire and support sleeve from backing out
of the bone canal. The cap may be screwed into the bone canal
(wherein the wire and sleeve occupy the bone canal), after the
break has been properly anchored as discussed previously. By
screwing (e.g., rotating) the cap into the bone such that the wire
and supporting sleeve rest inside of the cap blind hole 322, (see
FIG. 2N and 2O) the wire and support sleeve are partially or fully
prevented from backing out of the bone canal (or only minimally
back out of the bone canal). It may also be noted that this
embodiment may function without the presence of threaded sleeve
192.
[0127] In various other embodiments, the cap may not have a blind
hole, but instead acts as a plug when screwed into the bone canal.
In such an embodiment, the cap may be screwed into the bone canal
an optimal distance such that it does not apply excessive pressure
against the wire and sleeve, but also far enough so the wire and
sleeve are partially or fully prevented from backing out of the
bone canal.
[0128] In various other embodiments and illustrated in FIG. 2U, cap
1120 may have internal threads configured to mate with and/or
thread onto a threaded sleeve. In another embodiment, cap 1120 may
have internal cutting threads configured to cut onto the outside
surface of the tubular sleeve. In another embodiment, cap 1120 may
have external threads configured for threading into a retaining cap
in the bone. By engaging the bone (as discussed herein) and
retaining sleeve 1008, cap 1120 may constrain the sleeve in
relation to the entry point into the bone.
[0129] In various other embodiments, the cap and the threaded
(and/or tubular) sleeve may engage one with the other any way
discussed herein, in the incorporated references, or known in the
art. For example, the cap may employ a clutch mechanism to engage
the threaded or tubular sleeve. In another example, the cap may
employ a wedge mechanism to engage the threaded or tubular
sleeve.
[0130] Extractor/Driver 90, with reference to FIGS. 5A and 5B,
includes any device suitably configured to insert and/or extract
cap 20. In one embodiment, extractor 90 includes one or more ball
bearings 91, shaft 95, shaft end 93, handle 92 which receives shaft
end 93, tip sleeve 94, tip 96, and/or spring 97. Tip 96 may be the
end of a long rod which extends upward into handle 92. Spring 97
applies pressure against the upper end of the rod that emanates
from tip 96, thereby asserting a load against tip 96. Tip 96 is
thus configured to be received into inlet 74 of cap 20 and the
spring-load maintains tip 96 in inlet 74. Tip sleeve 94 is
configured to receive cap 20 to also facilitate rotation and/or
translation of cap 20. Tip 96 is mounted on a disc such that it
allows tip sleeve 94 to more fully receive cap 20. The disc also
rotates such that extractor 90 may rotate around cap 20, with
minimal or no movement of tip 96. Ball bearings 91 are configured
to facilitate rotation of tip sleeve 94 around outer surface of cap
20.
[0131] Another embodiment of extractor/driver 90 is shown in FIG.
5C. In this alternative embodiment, the rod may have a first end
which includes tip 96, and a second end 98 which may exit handle 92
such that the user may apply pressure to the second end 98 of the
rod, thereby similarly applying pressure and a load against tip 96.
Exit handle 92 also rotates such that it enables rotation of tip 96
which allows the user to rotate tip 96 until tip 96 mates with the
inlet in cap 20. In another embodiment, collet sleeve 99 is
attached to collet advancing handle 89. Collet advancing handle 89
includes a threaded inner surface which is configured to advance
shaft 95, and thus, advance collet sleeve 99 forward over cap 20 to
facilitate grasping of cap 20 for removal of cap 20.
[0132] A tensioner 50 may also be used in conjunction with various
embodiments. With respect to FIG. 3A, tensioner 50 is any device
suitably configured to insert a cap 20 into an object and/or
provide tension to a wire 12. In one embodiment, tensioner 50
increases the pressure between the surfaces of pathology by
providing force to a wire 12 while the anchor component 2 of wire
12 is fixed into a bone or far cortex. In an exemplary embodiment,
tensioner 50 includes a handle 52 with a hand trigger 54, wherein
the handle 52 supports a rotatable barrel 56 which mates with a
cylindrical rod 58. Cylindrical rod 58 may be cannulated to receive
wire 12 and/or have a driver 60 (e.g., hex, phillips, screw, allen
and/or the like) at its distal end for mating with the tool
attachment 10 of anchor component 2. The barrel 56 may be rotated
manually or automatically in order to rotate the driver 60 into the
object (e.g., bone or cortex). In one embodiment, tensioner 50
includes a means for exerting a force on wire 12, such as, for
example, internal gears 64, wherein the gears 64 include an
interface component 66 (e.g., saw tooth) which mate with the
inverse sawtooth 20 on wire 12. By pivoting the hand trigger 54,
the internal gears are rotated such that the gears cause wire 12 to
translate out the back end 62 of the tensioner 50, thereby exerting
force on wire 12 which is fixed at its distal end. The tensioner 50
may also include a gauge type device or any other device which is
suitably configured to measure and/or display the tension exerted
on wire 12.
[0133] Another embodiment of a tensioner (e.g., tensioner 101) is
shown in FIG. 3B. In one embodiment, tensioner 100 includes a base
101, a DVR connect component 102, a handle 103, a lock 104, and/or
a spring link 106. Tensioner 100 is configured to accept multiple
size wires and may include an indicator to show the amount of
tension being applied. Tensioner 101 is also configured such that
extractor 90 may clip into tensioner 101. Other embodiments of
tensioners are disclosed in U.S. application Ser. No. 12/104,328,
filed on Apr. 16, 2008 and entitled "TENSIONING SYSTEM AND METHOD
FOR THE FIXATION OF BONE FRACTURES," which is herein incorporated
by reference in its entirety.
[0134] After tensioning wire 12 to the desired tension, wire 12 may
be cut, broken or shortened using any known device or method. With
reference to FIG. 6, cutter 200 may be used. Cutter 200, in one
embodiment, includes insert left 201, insert right 202, jaw left
203, jaw right 204, cutter left 205, and cutter right 206. Cutter
200 includes a cutting surface that extends beyond the main body of
cutter 200 such that the wire may be cut from various angles.
[0135] The various components discussed herein can be suitably
configured to perform the following method, wherein the steps can
be performed in any order and any individual step is not necessary
to the method. In an exemplary embodiment, a cannulated lagwire
driver is suitably attached to a surgical drill, such that the
drill allows for automatic rotation of the driver. The wire 12 of
lagwire system 1 is placed into the channel of the driver such that
the end of the driver encompasses or is received into driver head
10 of anchor component 2, thereby allowing wire 12 to be drilled
into the bone. In one embodiment, anchor component 2 is configured
with a hex head as the driver head 10 such that the driver suitably
mates to the hex head. The anchor component 2 and wire 12 are then
drilled into the bone to a desired depth using the automatic
surgical drill (or any other manual or automatic device for
rotating anchor component 2). Specifically, drill tip 4 of anchor
component 2 facilitates the drilling of a pilot hole, wherein the
proximal cutting threads 6 tap the bone for threading the inner
surface of the hole, then the proximal mating threads 8
rotationally mate with the newly created threaded surface, thereby
temporarily attaching the anchor component 2 into the cortex of the
bone.
[0136] After attaching the anchor component 2 to the bone, the
surgical drill is removed and a cap 20 is threaded onto the
proximal end 14 of wire 12. Cap 20 is then translated distally
along wire 12 until cap 20 contacts the bone or other desired
pathology. In one embodiment, a lagwire tensioner is used to exert
tension on the lagwire. In another embodiment, a lagwire tensioner
50 may be used to force or seat cap 20 into the bone surface or any
other desired position. The hex head 60 of the tensioner 50 may be
used to screw cap 20 into the bone surface. In another embodiment,
the lagwire tensioner 50 exerts tension on the lagwire 12 up to a
desired tension which may be read from a gauge communicating with
the tensioner.
[0137] After positioning the lagwire device 1 and applying the
appropriate amount of tension, in one embodiment, the excess wire
12 may be suitably removed by, for example, a wire cutter or any
other suitable device. In another embodiment, a crimp type device
may be placed on wire 12 to also help maintain tension. The crimp
may include a clamp type device, bending the existing wire 12,
screwing a nut onto the end of wire 12 and/or the like. The crimp
may be placed on wire 12 after cap 20 is set in place, for example,
in order to crimp other end pieces together. The tensioner 50 may
also be used to reverse screw cap 20 in order to remove a wire 12
out of the bone. Moreover, in a situation where anchor component 2
strips out of the bone (for example, when the bone is of poor
quality), the present system allows the lagwire to be pushed
through the opposite side of the bone and through the skin such
that the anchor component 2 of wire 12 can be suitably removed
(e.g., cut off) and a cap 20 can be placed onto that end of the
lagwire, thereby resulting in better purchase (e.g., quality of
fixation) of the bone.
[0138] With respect to FIGS. 4A-4G, the lagwire system discussed
herein can be used for the fixation of various types of bone
fractures. FIG. 4A shows the use for an exemplary fixation of a
bone fracture or break. FIGS. 4B-4D show the use for an exemplary
fixation of fractures of certain portions of bones. Moreover, as
shown in exemplary FIGS. 4F and 4G, the lagwire system 1 may also
be used in a similar manner discussed herein in order to assist in
holding a plate to the bone to help fix certain types of fractures.
In other types of fractures, the lagwire may be placed through an
entire limb to, for example, attach an external fixation device to
the limb as shown in exemplary FIG. 4E. Other embodiments of bone
plates and related adapters are disclosed in U.S. application Ser.
No. 12/104,658, filed on Apr. 17, 2008 and entitled "ADJUSTABLE
BONE PLATE FIXATION SYSTEM AND METHOD," U.S. application Ser. No.
12/258,013, filed on Oct. 24, 2008 and entitled "BONE SCREW SYSTEM
AND METHOD," and U.S. application Ser. No. 12/369,589, filed on
Feb. 11, 2009 and entitled "STABILIZATION SYSTEM AND METHOD FOR THE
FIXATION OF BONE FRACTURES," which are herein incorporated by
reference in their entirety.
[0139] FIG. 4H shows a fixation of a vertebrae in accordance with
an exemplary embodiment. The screw is inserted into the vertebrae,
then a cap is fitted onto the end of the wire. The cap is specially
constructed such that the cap attaches to a rod. The rod may extend
along various vertebrae such that the lagwires may extend from
various vertebrae and all connect to the same rod. Another screw
and lagwire may be inserted into the other side of the vertebrae
such that the wire extends from the other side of the vertebrae and
its cap connects to a second rod on the other side of the vertebrae
for additional stability.
[0140] As described herein, the system and method provides a device
which is self-drilling, self-tapping and can be inserted under
power. The invention also facilitates reducing and fixing fractures
in one step. As such, the invention substantially expedites the
process for fixation of bone fractures which is, of course,
critical during trauma situations in order to stabilize a patient
or to minimize the amount of time the patient is on the operating
table or under anesthesia. In contrast to typical prior art screws
wherein a gliding hole in the near cortex simply guides the screw,
the present invention provides the ability for two sides of cortex
bone screw fixation. Moreover, because of the strength of the
attachment to the bone, the invention enables sufficient fixation
even in poor quality bone material. Furthermore, wherein the prior
art systems often require the use of cannulated screws in order to
utilize a guidewire for placement, the present invention does not
require the use of cannulated screws. Because the lagwire includes
a tip 4 which creates a pilot hole, taps the bone for threads and
fixes the threads into the bone, the system and method minimizes
the possibility of inaccurate placement into the distal cortex or
missing the distal hole.
[0141] In prior art systems, the physician typically cuts a
relatively large opening in the skin in order to locate the bone
segments, pull the bone segments into alignment, then place the
screw into the bones. In the present invention, the system
facilitates the percutaneous technique by allowing the physician to
cut a minor incision into the skin for the anchor component, insert
the anchor component, then pull the bones together with wire 12 and
set the cap, all without large incisions or additional
incisions.
[0142] Another embodiment for a bone fixation device includes a
collapsing bone fixation device which is suitably configured to
collapse in association with a fracture collapse to minimize or
prevent the device from protruding beyond the bone. In an exemplary
embodiment, the bone fixation device also includes an internal
(i.e., minimal or no contact with the bone) compressive device 140
to maintain compression across the fracture during fracture
collapse (e.g., weight bearing by the patient).
[0143] Other embodiments for sleeves, and in particular, for
sleeves used in connection with guide tubes, are disclosed in U.S.
application Ser. No. 12/163,122, filed on Jun. 27, 2008 and
entitled "GUIDE SYSTEM AND METHOD FOR THE FIXATION OF BONE
FRACTURES," which is herein incorporated by reference in its
entirety.
[0144] In other embodiments of systems, methods, and devices
discussed herein, the systems, methods, and devices may incorporate
various features, components, devices, systems, and/or methods for
the fixation of bone fractures as described in U.S. application
Ser. No. 12/769,529, filed on Apr. 28, 2010 and entitled "BONE
SCREW SYSTEM AND METHOD FOR THE FIXATION OF BONE FRACTURES," which
is herein incorporated by reference in its entirety.
[0145] The present invention is described herein in connection with
the fixation of bone fractures; however, one skilled in the art
will appreciate that the lagwire system and method described herein
may also be used for changing, maintaining, reducing or expanding
the distance between objects, object portions, or surfaces,
compressing objects or object portions together, or providing
pressure to surfaces. For example, the present invention may be
used to repair wood products, tree limb damage, breaks in supports
or columns, cracks in sculptures or buildings, fractures in
sections of concrete or other building materials, cracks or breaks
in car parts and/or the like.
[0146] In the foregoing specification, the invention has been
described with reference to specific embodiments. Various
modifications and changes can be made, however, without departing
from the scope as set forth in the claims below. The specification
and figures are to be regarded in an illustrative manner, rather
than a restrictive one, and all such modifications are intended to
be included within the scope of present invention. Accordingly, the
scope of the invention should be determined by the appended claims
and their legal equivalents, rather than by the examples given
above. For example, the steps recited in any of the method or
process claims may be executed in any order and are not limited to
the order presented in the claims.
[0147] Benefits, other advantages, and solutions to problems have
been described herein with regard to specific embodiments. However,
the benefits, advantages, solutions to problems, and any elements
that may cause any benefit, advantage, or solution to occur or
become more pronounced are not to be construed as critical,
required, or essential features or elements of the invention. The
scope of the invention is accordingly to be limited by nothing
other than the appended claims, in which reference to an element in
the singular is not intended to mean "one and only one" unless
explicitly so stated, but rather "one or more." Moreover, where a
phrase similar to `at least one of A, B, and C` is used in the
claims, it is intended that the phrase be interpreted to mean that
A alone may be present in an embodiment, B alone may be present in
an embodiment, C alone may be present in an embodiment, or that any
combination of the elements A, B and C may be present in a single
embodiment; for example, A and B, A and C, B and C, or A and B and
C. All structural, chemical, and functional equivalents to the
elements of the above-described exemplary embodiments that are
known to those of ordinary skill in the art are expressly
incorporated herein by reference and are intended to be encompassed
by the present claims. Further, a list of elements does not include
only those elements but may include other elements not expressly
listed or inherent to such process, method, article, or
apparatus.
* * * * *