U.S. patent number RE46,855 [Application Number 15/454,674] was granted by the patent office on 2018-05-22 for k-wire and method for surgical procedures.
This patent grant is currently assigned to Orthovita, Inc.. The grantee listed for this patent is Orthovita, Inc.. Invention is credited to Arden Allen Geist, Sr., Wyatt Drake Geist.
United States Patent |
RE46,855 |
Geist , et al. |
May 22, 2018 |
**Please see images for:
( Certificate of Correction ) ** |
K-wire and method for surgical procedures
Abstract
A surgical guide wire or K-wire and method of use are provided.
The K-wire or guide wire has opposite end portions and a shank
portion in between. One end portion has a deformable end portion
that, once outside of a confining guide passage, can be deformed to
present a projected forward facing area that is larger than the
transverse cross section of the K-wire or guide wire while in the
passage. The increased area will provide increased resistance to
additional forward axial movement into the surgical site.
Inventors: |
Geist; Wyatt Drake (Davie,
FL), Geist, Sr.; Arden Allen (Indialantic, FL) |
Applicant: |
Name |
City |
State |
Country |
Type |
Orthovita, Inc. |
Malvern |
PA |
US |
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Assignee: |
Orthovita, Inc. (Malvern,
PA)
|
Family
ID: |
42979808 |
Appl.
No.: |
15/454,674 |
Filed: |
March 9, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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13974747 |
May 6, 2014 |
8715311 |
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13722641 |
Sep 24, 2013 |
8540747 |
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12823791 |
Jan 29, 2013 |
8361102 |
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61220828 |
Jun 26, 2009 |
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Reissue of: |
14269984 |
May 5, 2014 |
8979889 |
Mar 17, 2015 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B
17/8897 (20130101); A61B 17/8897 (20130101); A61B
2017/564 (20130101) |
Current International
Class: |
A61M
29/00 (20060101); A61B 17/56 (20060101); A61B
17/88 (20060101) |
Field of
Search: |
;606/198,313,326-327
;604/164.13 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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10057398 |
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Mar 1998 |
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JP |
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H1057398 |
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Mar 1998 |
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JP |
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2008528109 |
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Jul 2008 |
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JP |
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2006078743 |
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Jul 2006 |
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WO |
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2007106081 |
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Sep 2007 |
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WO |
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Other References
Extended European Search Report for Application No. 15198750.0
dated Apr. 8, 2016. cited by applicant .
PCT/US2010/040032 International Search Report dated Feb. 4, 2011.
cited by applicant .
PCT/US2010/040032 Written Opinion of the International Searching
Authority dated Dec. 26, 2011. cited by applicant.
|
Primary Examiner: Flanagan; Beverly M
Attorney, Agent or Firm: Lerner, David, Littenberg, Krumholz
& Mentlik, LLP
Parent Case Text
CROSS REFERENCE TO RELATED APPLICATION
In accordance with 37 C.F.R 1.76, a claim of priority is included
in an Application Data Sheet filed concurrently herewith.
Accordingly, under 35 U.S.C. .sctn. 119.[.(e).]..Iadd.C=.Iaddend.,
120, 121, and/or 365(c), the present .[.invention.].
.Iadd.application is a reissue of U.S. application Ser. No.
14/269,984 filed on May 5, 2014, entitled "K-Wire and Method for
Surgical Procedures" now issued U.S. Pat. No. 8,979,889, which
issued on Mar. 17, 2015, which .Iaddend.claims priority as a
continuation of U.S. Non-Provisional Utility application Ser. No.
13/974,747, filed Aug. 23, 2013, entitled, "K-Wire and Method for
Surgical Procedures", .Iadd.now issued U.S. Pat. No. 8,715,311,
which issued on May 6, 2014, .Iaddend.which is a
continuation-in-part to U.S. Non-Provisional Utility application
Ser. No. 13/722,641, filed Dec. 20, 2012, entitled "K-Wire and
Method for Surgical Procedures", now issued U.S. Pat. No.
8,540,747, which issued on Sep. 24, 2013, which is a
continuation-in-part to U.S. Non-Provisional Utility application
Ser. No. 12/823,791, filed Jun. 25, 2010, entitled, "K-Wire and
Method for Surgical Procedures", now issued U.S. Pat. No.
8,361,102, which issued on Jan. 29, 2013, which claims priority to
U.S. Provisional Patent Application No. 61/220,828, filed Jun. 26,
2009, entitled, "K-Wire and Method for Surgical Procedures". The
contents of each of the above referenced applications are herein
incorporated by reference in its entirety.
Claims
What is claimed is:
1. A method of conducting a medical procedure using a guide wire,
the method including: placing a surgical tool end at a surgical
site, said surgical tool having a guiding through bore opening at
the tool end; guiding a guide wire to the site by passing the guide
wire through the passage, said guide wire having an operative end
portion; and deforming a portion of the operative end portion after
its exit from the passage such that the deformed portion presents a
projected area greater than the cross sectional area of the guide
wire when in the passage, wherein said operative end portion
comprising a first independent deformable leg and a second
independent deformable leg, each said independent deformable leg
diverging from a common area of said guide wire, said independent
deformable legs predisposed to move in an outward direction with
respect to each other and forming a first gap extending the length
of said independent deformable legs; one independent deformable leg
being longer than said second independent deformable leg, said
longer independent deformable leg including a tip portion that is
constructed to overlap a tip portion of the said shorter
independent deformable leg and forming a second gap between said
tip portions, said second gap formed generally perpendicular to the
guide wire longitudinal axis when in the non-deformed state,
wherein each said opposing deformable legs contains a bend
positioned distally from the point where said opposing independent
deformable leg diverge from said common area of said guide wire,
wherein at least one independent deformable leg contains a groove
sized to receive a projection and said opposite independent
deformable leg contains a projection sized and shaped to fit within
said groove.
2. The method of claim 1 wherein the deforming occurs
automatically.
3. The method of claim 1 wherein the deforming is induced by
increasing the temperature of the operative end portion.
4. The method of claim 1 wherein the operative end portion has a
deformable portion constructed of memory metal alloy.
5. The method of claim 1 wherein the deforming is induced by
relieving stress induced into the operative end portion when in the
guiding passage.
6. The method of claim 1 wherein the operative end portion has a
deformable portion constructed of a spring material.
7. A method of conducting a medical procedure using a K-wire, the
method including: placing a surgical tool end at a surgical site,
said surgical tool having a guiding through bore opening at the
tool end; guiding a K-wire to the site by passing the K-wire
through the passage, said K-wire having an operative end portion;
and deforming a portion of the operative end portion after its exit
from the passage such that the deformed portion presents a
projected area greater than the cross sectional area of the K-wire
when in the passage, wherein said operative end portion comprising
a first independent deformable leg and a second independent
deformable leg, each said independent deformable leg diverging from
a common area of said K-wire, said independent deformable legs
predisposed to move in an outward direction with respect to each
other and forming a first gap extending the length of said
independent deformable legs; one independent deformable leg being
longer than said second independent deformable leg, said longer
independent deformable leg including a tip portion that is
constructed to overlap a tip portion of the said shorter
independent deformable leg and forming a second gap between said
tip portions, said second gap formed generally perpendicular to the
K-wire longitudinal axis when in the non-deformed state, wherein
each said opposing deformable legs contains a bend positioned
distally from the point where said opposing independent deformable
leg diverge from said common area of said K-wire, wherein at least
one independent deformable leg contains a groove sized to receive a
projection and said opposite independent deformable leg contains a
projection sized and shaped to fit within said groove.
.Iadd.8. The method of claim 1, wherein the surgical site is a
vertebral body. .Iaddend.
.Iadd.9. The method of claim 7, wherein the surgical site is a
vertebral body. .Iaddend.
.Iadd.10. A method of conducting a medical procedure using a guide
wire, the method including: contacting a surgical tool with a
vertebral body; placing a guide wire through the surgical tool, the
guide wire having an operative end portion in a first position
while in the surgical tool, the guide wire being monolithic and
bifurcating into two portions at the operative end portion; and
inserting the operative end portion of the guide wire into the
vertebral body, the operative end portion being in a second
position in the vertebral body, wherein a projected area of the
operative end in the second position is greater than a cross
sectional area of the operative end in the first position.
.Iaddend.
.Iadd.11. The method of claim 10, wherein the operative end portion
includes a first independent deformable leg and a second
independent deformable leg, each independent deformable leg
diverging from a common area of the guide wire. .Iaddend.
.Iadd.12. The method of claim 11, wherein the independent
deformable legs are predisposed to move in an outward direction
with respect to each other to form a first gap extending the length
of the independent deformable legs. .Iaddend.
.Iadd.13. The method of claim 12, wherein one independent
deformable leg is longer than the other independent deformable leg,
the longer independent deformable leg including a tip portion that
overlaps a tip portion of the shorter independent deformable leg in
the first position. .Iaddend.
.Iadd.14. The method of claim 11, wherein each opposing deformable
leg contains a bend positioned distally from the point where the
opposing independent deformable leg diverges from said common area
of the guide wire. .Iaddend.
.Iadd.15. The method of claim 11, wherein at least one independent
deformable leg contains a groove sized to receive a projection and
the other independent deformable leg contains a projection sized
and shaped to fit within the groove. .Iaddend.
.Iadd.16. The method of claim 10, wherein said operative end
includes substantially linear first and second independent
deformable legs, the independent deformable legs being
substantially parallel to each other in the first position and
diverging from a longitudinal axis of the guide wire in the second
position. .Iaddend.
.Iadd.17. The method of claim 10, wherein the movement between the
first and second positions occurs automatically. .Iaddend.
.Iadd.18. The method of claim 10, wherein the operative end portion
has a deformable portion constructed of memory metal alloy.
.Iaddend.
.Iadd.19. The method of claim 10, wherein the movement between the
first and second positions is induced by relieving stress induced
into the operative end portion when in the guiding passage.
.Iaddend.
.Iadd.20. The method of claim 10, wherein the operative end portion
has a deformable portion constructed of a spring material.
.Iaddend.
.Iadd.21. The method of claim 10, wherein the surgical tool is a
jamshidi needle. .Iaddend.
.Iadd.22. The method of claim 10, further including the step of
removing the surgical tool by pulling on the surgical tool and
pushing down on the guide wire. .Iaddend.
.Iadd.23. The method of claim 10, further including the step of
using the operative end of the guide wire as a marker or a stop for
placing a second surgical tool. .Iaddend.
.Iadd.24. A method of conducting a medical procedure using a guide
wire, the method including: contacting a surgical tool with a
vertebral body; placing a guide wire having at least two deformable
legs through the surgical tool, the deformable legs being in a
first position in the surgical tool, the guide wire being
monolithic and bifurcating into the two deformable legs at a distal
end of the guide wire; and inserting the deformable legs into the
vertebral body, the deformable legs being in the second position in
the vertebral body, wherein the deformable legs are separated a
greater distance from each other in the second position than in the
first position. .Iaddend.
.Iadd.25. The method of claim 24, wherein the two deformable legs
are substantially linear, the deformable legs being substantially
parallel to each other in the first position and diverging from a
longitudinal axis of the guide wire in the second position.
.Iaddend.
.Iadd.26. The method of claim 24 wherein the surgical tool is a
jamshidi needle. .Iaddend.
.Iadd.27. The method of claim 24, further including the step of
removing the surgical tool by pulling on the surgical tool and
pushing down on the guide wire. .Iaddend.
.Iadd.28. The method of claim 24, further including the step of
using the deformable legs as a marker or a stop for placing a
second surgical tool. .Iaddend.
.Iadd.29. A method of securing a guide wire in a vertebral body,
the method comprising: placing a distal end of a surgical tool on a
predetermined location on a vertebral body, the surgical tool
including a through bore having an bore diameter; guiding a guide
wire through the through bore; and securing the guide wire to the
vertebral body by extending the guide wire beyond the distal end of
the surgical tool; wherein the guide wire is monolithic and
bifurcates at a distal end of the guide wire into first and second
substantially linear legs each having a free end, such that the
distance between the free ends measured perpendicular to a
longitudinal axis of the guide wire is less than or equal to the
bore diameter when in the through bore and greater than the bore
diameter when extended past the distal end of the surgical tool.
.Iaddend.
.Iadd.30. A method of conducting a medical procedure using a guide
wire, the method including: contacting a surgical tool with a
vertebral body; placing a guide wire through the surgical tool, the
guide wire having an operative end portion in a first position
while in the surgical tool; and inserting the operative end portion
of the guide wire into the vertebral body, the operative end
portion being in a second position in the vertebral body, wherein a
projected area of the operative end in the second position is
greater than a cross sectional area of the operative end in the
first position, wherein the operative end portion includes a first
independent deformable leg and a second independent deformable leg,
each independent deformable leg diverging from a common area of the
guide wire, wherein at least one independent deformable leg
contains a groove sized to receive a projection and the other
independent deformable leg contains a projection sized and shaped
to fit within the groove. .Iaddend.
Description
FIELD OF INVENTION
The present invention relates to an improved guide wire or K-wire
for use in surgical procedures such as orthopedic procedures, and
in particular, spinal procedures such as percutaneous pedicle screw
constructs.
BACKGROUND OF THE INVENTION
In certain surgical procedures, a K-wire (Kirschner wire) or guide
wire is used in combination with a surgical tool such as a jamshidi
needle. The jamshidi needle is used to form a hole through bone as
a first step in certain medical procedures like attaching a screw
to a pedicle. The K-wire or guide wire is inserted through the
needle into the interior of the bone, which, if not done properly,
can injure the patient, particularly if it engages certain
sensitive parts which may include breaching the anterior cortex of
a vertebral body. The K-wire or guide wire is used as a portal for
certain surgical steps like guiding a tap, screw or screwdriver to
the surgical site. The procedures oftentimes require the use of
force which can cause a properly positioned K-wire or guide wire to
move forward into the surgical site, which, if excessive, can move
into contact where contact is to be avoided.
A K-wire or guide wire is generally cylindrical and has a diameter
of about 3 millimeters, making it easy to move during use. In fact,
the K-wire or guide wire is designed to move during its
installation; however, once installed its movement is not impeded,
requiring care in its use. The cross sectional size of the K-wire
though is limited by the tools and devices it is used with. Each
tool or device is provided with a through bore for receiving the
K-wire or guide wire, limiting the size and type of wire that can
be used. Additionally, the K-wire is typically removed by passing
through a through bore in a device or tool. Thus, to date, only
K-wires with a small diameter, generally cylindrical round cross
section, have been used which presents the problem in their use. It
should also be noted that while the K-wires or guide wires
illustrated herein include a solid center core, the K-wire or guide
wire may be a hollow tubular member without departing from the
scope of the invention.
The present invention provides a solution to this problem by
providing an improved K-wire or guide wire which, when inserted,
provides increased resistance to forward axial movement while still
being usable with traditional surgical tools and devices.
DESCRIPTION OF THE PRIOR ART
U.S. Pat. No. 5,431,651 discloses a cross pin and set screw femoral
and tibial fixation device for mounting a ligament graft. The
device includes a drill guide for drilling a transverse hole. The
drill guide is releasable from a first twist drill so as to leave
it in place. The first twist drill is used to guide further
drilling and passage of a fastener device. A K-wire or the first
twist drill is used for guiding a second twist drill for enlarging
the transverse hole and for guiding and turning a cannulated
fastener device into a femoral bone end of the ligament graft.
There is no feature on the K-wire to limit the extent of its
insertion subsequent to it passing through the bone.
U.S. Pat. No. 7,575,578 discloses a surgical drill guide including
a handle and an arm having an end which contacts a bone. The handle
includes a plurality of slots or channels which receive a sleeve.
The sleeve is used to guide a K-wire into the bone. The K-wire
serves as a guide for drilling a tunnel into the bone. The K-wire
does not include a feature to limit the extent of its insertion
subsequent to it passing through the bone.
U.S. Published Patent Application No. 2007/0239159 discloses
devices and a system for placing bone stabilization components in
an individual. In particular, the bone stabilization components are
placed on the spine. Various tools, including a K-wire, are
employed to properly locate, place and secure the devices in an
individual.
U.S. Published Patent Application No. 2007/0270896 discloses a
device for accessing the pedicle of a vertebra including a Jamshidi
needle.
SUMMARY
The present invention involves the provision of a K-wire which can
be used with traditional surgical tools and devices. The inventive
guide wire or K-wire has an end portion that, upon exit from the
through bore of a surgical tool or device, can be changed in a
controlled manner to present a deformable end portion that will
provide a forward face with a larger projected area than the end
surface of the K-wire while in the through bore. The deformation
may be induced mechanically from internal stress, thermally or
otherwise.
The present invention also involves the provision of a method of
conducting surgery utilizing a guide wire or K-wire. The method
includes passing a guide wire or K-wire through a tool or device
into a surgical slit with the guide wire or K-wire presenting a
forward facing area of a first size. The guide wire or K-wire then
has an end portion moved out of the tool or device where the
forward end portion can be expanded to present a forward facing
area of a second size larger than the first size. After use, the
guide wire or K-wire may be extracted from the surgical site
through a surgical tool or device.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a schematic plan view of vertebra showing a jamshidi
needle extending through a pedicle;
FIGS. 2A, 2B are side elevation views of a K-wire or guide wire
showing two configurations of one end portion of the K-wire or
guide wire;
FIG. 3 is an enlarged fragmentary view of a K-wire or guide wire
showing an end portion shown configured to present an expanded
forward face;
FIG. 4 is a fragmentary side sectional view of a jamshidi needle
with a K-wire or guide wire in a through bore;
FIGS. 5A and 5B are enlarged fragmentary side views of an end
portion of a K-wire or guide wire with one embodiment of reformable
end portion;
FIGS. 6A and 6B are enlarged side views of an end portion, expanded
and unexpanded, of a further embodiment of a K-wire or guide wire
of the present invention;
FIG. 7 is an enlarged side view of an end portion of a still
further embodiment of a K-wire or guide wire of the present
invention;
FIG. 8 is an enlarged side view of an end portion of a still
further embodiment of a K-wire or guide wire of an end portion of
the present invention;
FIG. 9 is an enlarged side view of an end portion of an embodiment
of the invention similar to that shown in FIG. 2B;
FIG. 10 is an enlarged side view of an end portion of a still
further embodiment of the present invention;
FIG. 11 is an enlarged side view of the embodiment illustrated in
FIG. 10 with the end portions spread apart;
FIG. 12 is an enlarged side view of a still further embodiment of
the present invention;
FIG. 13 is an enlarged side view of a still further embodiment of
the present invention; and
FIG. 14 is a view of the present invention used in a surgical
procedure.
Like numbers used throughout the Figures designate like or similar
parts and/or construction.
DETAILED DESCRIPTION OF THE INVENTION
While the present invention is susceptible of embodiment in various
forms, there is shown in the drawings and will hereinafter be
described presently preferred embodiments with the understanding
that the present disclosure is to be considered an exemplification
of the invention and is not intended to limit the invention to the
specific embodiments illustrated.
Referring generally to the figures, the reference numeral 10
designates generally a K-wire or guide wire usable in surgical
procedures in combination with a surgical tool such as a jamshidi
needle 12, drill or tap (not shown), or a surgical device such as a
screw, plate or implant. K-wires (also called Kirschner wires) or
guide wires are well known in the art. Jamshidi needles are also
well known in the art and have a shank 14 with a through bore 16
(as would a drill, tap or screw) and a sharpened distal end 17. A
handle 18 may also be provided at the proximal end 20 of the shank
14 for facilitating insertion of the shank into a surgical site 21,
such as a vertebra 22 with a pedicle 23 in a patient such as a
human. A surgeon may manipulate the jamshidi needle 12 using the
handle 18, and may also apply impact force to the shank 14 by
striking the handle with a hand or impact tool such as a hammer.
Jamshidi needles are used to penetrate bone in the performance of a
surgical procedure such as attaching a screw 24 to bone. A rod (not
shown) may be installed in the through bore 16 during hole
formation to increase rigidity of the shank 14. The rod is removed
to provide a through bore 16 for the K-wire 10 insertion. After
forming a hole 25 with the jamshidi needle 12, the K-wire or guide
wire 10 is inserted into the interior of the bone and the jamshidi
needle is removed, leaving the K-wire or guide wire in place. In
some surgical procedures, like spinal surgery, the K-wire or guide
wire is inserted through one wall of a bone, e.g., a pedicle 23 and
is placed against an opposite bone wall. If care is not taken
during surgery, the K-wire or guide wire may be pushed through the
opposing bone wall creating a risk of injury. The present invention
is a solution to this potential problem.
The K-wire or guide wire 10 is typically used as a pilot or guide
for other surgical tools or devices such as drills, taps, plates,
implants and screws. In the attachment of a screw 24 (FIG. 5B), the
screw can have a through bore 44 that receives the K-wire or guide
wire for guiding the screw to a drilled and tapped hole 25. After
installation of the screw 24, the K-wire or guide wire 10 is then
extracted through the through bore 44 of the screw 24 by simply
pulling on the K-wire or guide wire to reduce the frontal area of
the K-wire or guide wire substantially to its original size.
The K-wire or guide wire 10 has opposite end portions 26, 28 and a
generally cylindrical intermediate portion 30 positioned between
the end portions. The length of the K-wire or guide wire 10 is
preferably long enough to extend beyond both ends of the surgical
tool being used, e.g., a jamshidi needle 12. The K-wire or guide
wire 10 is sized and shaped to be freely movable along the through
bore 16. The end portion 28 will be referred to as the manipulative
end and the end portion 26 will be referred to as the operative end
for convenience. Preferably, the entire length of the manipulative
end portion 28 and the intermediate portion 30 is generally
cylindrical to facilitate removal of a tool or device from an
installed K-wire or guide wire 10.
The operative end portion 26 is provided with a section 32 that is
controllably deformable. The section 32 may be an integral portion
of the K-wire or guide wire 10 or attached thereto. Several
different sections 32 are described below. In general, the section
32 is configurable to fit within the through bore 16 and freely
movable therein. It is insertable into the through bore 16 for
insertion into the surgical site 21 for use and for removal from a
through bore in the tool or device. The K-wire or guide wire may
also be removed prior to a later surgical step if it is no longer
needed. For example, if the K-wire or guide wire is not needed to
guide the screw 24 for insertion, it may be removed prior to
attaching the screw 24. When outside of the through bore 16, the
operative end 26 expands automatically or can be manually expanded
to present an expanded face with a projected area greater than the
transverse cross sectional area of the K-wire or guide wire 10
while positioned in the through bore 16. By way of example, the
operative end 26 seen in FIG. 3 has a projected area of
approximately (given that the end 33 of the bend at the
intermediate section 30 of K-wire or guide wire 10 is rounded
reducing the area slightly) L times W whereas the K-wire or guide
wire has a cross sectional area of A=.pi.r.sup.2 where r is equal
to W/2. It is preferred that the reconfigured cross sectional
projected area be at least about 1.5 times, and preferably at least
about twice the size of the first cross sectional area of the
K-wire or guide wire as described below.
The K-wire or guide wire 10 or the deformable portion 32 of the
K-wire or guide wire may be made of a deformable material which
will allow at least the operative end 26 to be configured between
first and second configurations (see FIGS. 2A and 2B) with one
configuration (FIG. 2B) presenting a larger projected area than the
first (FIG. 2A) as discussed above. One suitable reconfigurable
material is referred to as a shape memory alloy such as Nitinol. A
reversible, solid phase transformation known as martensitic
transformation is the force behind shape memory alloys. Such alloys
are well known and form a crystal structure which is capable of
undergoing a change from one form of crystal structure to another.
Temperature change and/or loading can initiate the shape
transformation. By way of example, above its transformation
temperature, Nitinol is superelastic, able to withstand deformation
when a load is applied and return to its original shape when the
load is removed. Below its transformation temperature, it displays
the shape memory effect. When it is deformed below its
transformation temperature, it will remain in that shape until
heated above its transformation temperature, at which time it will
return to its original shape. The original shape would then be the
bent form and then it can be reformed cold to straight. Upon
heating, the bend will return. The heat (or temperature increase)
can be provided by contact with the patient. Elastically deformable
materials may also be used, such as spring steel with high yield
strength, where stress is induced to change a shape is elastically
released to change the shape of the deformed member back to its non
stressed shape. An embodiment of the invention, shown in FIGS. 5A
and 5B and described below, could be made using a spring material.
Plastically deformable materials might also be used for some
operative end portion 26 configurations. The terms resiliently
deformable, plastically deformable and spring are used generally to
indicate a material property when the material is deformed during
typical use of the K-wire or guide wire as described herein.
Controlled bending can be induced by using controlled weak points
such as a groove or the like at selected strategic locations. The
embodiment in FIGS. 5A and 5B might also be used with a plastically
deformable material. The screw 24 or other tool or device that is
anticipated to be the last one used with the K-wire or guide wire
10 may be provided with a forcing cone 35 to help reconfigure the
end portion 26 back to its unexpanded shape to conform it to fit
within a passage like passages 16, 44 for insertion or removal. An
embodiment of this form is seen in FIGS. 5A and 5B and is described
below.
In the embodiment shown in FIGS. 1-3, the operative end 26 has a
laterally extending portion 36 when out of the through bore 16. The
deformation to lateral extension may be provided as described above
by applying heat to effect bending from memory. The portion 36 may
be provided as a permanent bend in the K-wire or guide wire 10
which can then be deformed to straight by confinement in the
through bore 16, and upon exit from the through bore will reassume
its bent configuration. The material properties of the end portion
26 may be selected to provide for straightening of the bend for
removal through a passage or bore which may be facilitated, e.g.,
by the use of a forcing cone 35. The lateral extension presents a
larger projected area to further limit forward axial motion into
the surgical site.
FIG. 4 shows a surgical tool configuration that can be used to
facilitate directing a K-wire or guide wire 10 out of the through
bore 16. It uses a curved tip 37 to direct the exiting K-wire or
guide wire 10.
In the embodiment shown in FIGS. 5A and 5B, the operative end 26 is
in the form of an expandable cage 40 having a plurality of rods 42
that can assume an extended position; FIG. 5A illustrates a
contracted configuration of cage 40 when in a through bore 16 of
shank 14. FIG. 5B illustrates the cage 40 in its expanded
configuration and a screw positioned on the K-wire or guide wire
10. The embodiment of FIGS. 5A and 5B may be constructed in at
least two ways, resiliently deformable rods 42 or plastically
deformable rods 42. A memory metal alloy may be used. A polymeric
material such as PEEK may also be used for at least the rods 42. If
the rods 42 are elastically deformable, they can be formed as
biased to an outward or expanded configuration, where once outside
of the through bore 16 they will move outwardly to relieve induced
stress to provide the expanded configuration like in FIG. 5B. The
rods 42 may also be plastically deformable, and upon application of
axial force will move to an expanded position as in FIG. 5B. When
the K-wire or guide wire is in the through bore 16, the rods 42
assume or are in the collapsed configuration and when the rods 42
are outside of the bore, they assume or are forced into the
expanded position providing an increased projected area for
engagement with material in the surgical site as discussed above.
It is to be noted that the rods may also be made of a memory alloy
as described above. The forcing cone 35 may be used to facilitate
removal of the K-wire or guide wire 10 through the through bore 44.
The distal ends of the rods 42 may be held in place with an end cap
43. The projected area of the end portion 26 when expanded, as seen
in FIG. 5B, would be that area defined or bounded by outermost
extending portions of the rods 42 as at portions 46.
FIGS. 6A and 6B illustrate another embodiment of the invention.
FIG. 6A shows an end portion 26 with an expandable end bulb 50 that
may be made out of a memory alloy that, upon heating, assumes the
expanded configuration illustrated in FIG. 6B. This embodiment is
particularly adapted for use when extraction of the K-wire or guide
wire is other than through a tool or device passage.
FIG. 7 illustrates another embodiment of the invention. It utilizes
a pair of opposed legs 61, 62. The legs 61, 62 are constructed to
move in an outward direction either from spring action or from
otherwise reassuming a formed shape as from a temperature change as
by using a memory alloy as described above. In the illustrated
embodiment, the legs 61, 62 have overlying portions at 63.
FIG. 8 illustrates an additional embodiment of the invention and is
similar to the form shown in FIG. 7 by having two legs 71, 72, but
the legs do not overlap; rather the legs diverge from a common area
73 and have a gap 74 therebetween when in the extended position as
shown.
The embodiments of the invention shown in FIGS. 6-8 all utilize a
shank 14 of one material and an end portion of another material
such as a spring material or a memory alloy.
FIG. 9 illustrates a still further embodiment of the present
invention. It is similar to the K-wire or guide wire 10 shown in
FIG. 2 and has a shank 14 with an attached end portion 26 having a
single extending leg 80 shown in its extended configuration. The
portion 80 may be provided as a permanent bend in the K-wire or
guide wire 10 which can then be deformed to straight by confinement
in the through bore 16, and upon exit from the passage will
reassume its bent configuration. The material properties of the end
portion 80 may be selected to provide for straightening of the bend
for removal through a passage which may be facilitated, e.g., by
the use of a forcing cone. The lateral extension presents a larger
projected area to further limit forward axial motion into the
surgical site.
FIGS. 10 and 11 illustrate a still further embodiment of the
present invention. The end portion 26 of the K-wire or guide wire
includes a plurality of deformable ends, illustrated herein as
independent legs 82 and 84. The K-wire or guide wire of FIGS. 10
and 11 can be made from a shape memory alloy such as Nitinol. Other
shape memory alloys and materials can also be used. The ends 82 and
84 are normally deformed outwardly from the longitudinal axis 85 of
the K-wire or guide wire at a common area diverging point 87 as
shown in FIG. 11 within the guide wire. As such, the deformable
ends, or legs 82 and 84 form separate structures which can move
outwardly, independent of each other from the common area diverging
point 87. The legs 82 and 84 are separated by a gap 87 which runs
the length of the legs 82 and 84 and is orientated in a generally
parallel manner from the longitudinal axis 85 of the guide wire 10.
The deflection of the ends 82 and 84 presents a larger end surface
area when the K-wire or guide wire is penetrating a bone. This
larger end surface offers more resistance and consequently prevents
the K-wire or guide wire from penetrating too far into the bone and
perhaps passing into an adjacent bone or outside of the intended
bone. The length of the ends 82 and 84 together with the different
shape memory alloys determine how quickly the ends 82 and 84 deform
outwardly after they enter a bone. The more rapidly they deform,
the less they penetrate into a bone. The ends 82 and 84 collapse
together, as shown in FIG. 10, when the K-wire or guide wire is
withdrawn back through the Jamshidi needle. A groove 86 on end 82
permits projection 88 to fit therein when in the collapsed
position.
As further illustrated, the K-wire or guide wire 10 is shown with
one of the deformable ends being longer than the opposing
deformable end. As illustrated, leg 82 is longer than leg 84. Leg
82 includes a tip portion 89 that extends past and is bent inwardly
towards the leg 84 to overlap a tip portion 91 of the shorter leg
84. While most of the leg 82 is orientated in a generally parallel
manner relative to the leg 84, at least a segment of, if not all of
the tip portion 89 is positioned in a perpendicular orientation
relative to the leg 84. A second gap 93 separates the tip portions
89 and 91. The second gap 93 therefore is formed substantially
perpendicular to the longitudinal axis 85 when legs 82 and 84 are
in the non-deployed or not separated state.
FIGS. 12 and 13 illustrate other embodiments of the present
invention. These embodiments are variations of the embodiment
illustrated in FIGS. 10 and 11. In FIG. 12 the end 82 of the K-wire
or guide wire bends outwardly at 90. Also end 84 bends outwardly at
92. The bends 90 and 92 are positioned within the legs 82 and 84 at
some distance away from the common area diverging point 87, i.e.
towards the tip portions 89 and 91. This embodiment permits the
ends 82 and 84 to bend outwardly from the longitudinal axis more
rapidly than the embodiments of FIGS. 10 and 11. In FIG. 13, the
end 82 bends outwardly at 94 and the end 84 bends outwardly at 96.
Bends 94 and 96 are closer to the tip portions 89 and 91. Thus,
they permit the ends 82 and 84 to bend outwardly from the
longitudinal axis more rapidly than the bends 90 and 92 of FIG. 12.
The faster the ends move away from the longitudinal axis, the less
the K-wire or guide wire penetrates into the bone. Therefore, the
embodiment of FIG. 13 would penetrate less into a bone than the
embodiment of FIG. 12. Also the embodiment of FIG. 12 would
penetrate less into a bone than the embodiment of FIGS. 10 and
11.
The present invention also includes a method of conducting a
medical procedure using a K-wire or guide wire, as illustrated in
FIG. 14. A surgeon or other medical personnel places a surgical
tool end at the surgical site. The initial surgical tool used
preferably has a guiding through bore opening at the distal tool
end such as that described above for a jamshidi needle 12. A K-wire
or guide wire 10 is guided to the site by passing the K-wire or
guide wire through the through bore 16 until the operative end 26
extends beyond the open end of the through bore 16. A funnel 98
helps the surgeon place the K-wire or guide wire into the Jamshidi
needle. The operative end 26 of the K-wire has at least a portion
deformed after its exit from the through bore 16 such that the
deformed portion presents a projected area greater than the cross
sectional area of the K-wire or guide wire when in the through bore
16 as described above. The deformation can occur automatically as
by increasing the temperature of the operative end portion 26 when
it includes a memory metal alloy. The deformation may also be
induced by relieving stress induced into the operative end portion
as when the deformable portion is constructed of a spring material.
The deformation may also be induced mechanically by the application
of an axially directed force along the K-wire or guide wire 10.
After at least a portion of the surgery, the K-wire or guide wire
can be removed as described above. The K-wire or guide wire is used
to guide surgical tools and/or devices to the surgical site during
the surgical procedure. Once the K-wire or guide wire has been
inserted into the bone, the jamshidi needle can be withdrawn and a
cannulated tap or other instrument can be slid down the K-wire or
guide wire and inserted into the bone. When the tap reaches the
expanded ends 82, 84 of the K-wire it will stop its forward
progress. Thus, this invention avoids the need for fluoroscopy to
determine the position of the tap or other instrument in a
bone.
It is to be understood that while certain forms of the invention
are illustrated, it is not to be limited to the specific forms or
arrangements herein described and shown.
It will be apparent to those skilled in the art that various
changes may be made without departing from the scope of the
invention and the invention is not to be considered limited to what
is shown and described in the specification and any
drawings/figures included herein.
One skilled in the art will readily appreciate that the present
invention is well adapted to carry out the objectives and obtain
the ends and advantages mentioned, as well as those inherent
therein. The embodiments, methods, procedures and techniques
described herein are presently representative of the preferred
embodiments, are intended to be exemplary and are not intended as
limitations on the scope. Changes therein and other uses will occur
to those skilled in the art which are encompassed within the spirit
of the invention and are defined by the scope of the appended
claims. Although the invention has been described in connection
with specific preferred embodiments, it should be understood that
the invention as claimed should not be unduly limited to such
specific embodiments. Indeed, various modifications of the
described modes for carrying out the invention which are obvious to
those skilled in the art are intended to be within the scope of the
following claims.
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