Guidewire and method for surgical procedures
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.
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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. § 119(e), 120, 121, and/or 365(c) the present invention application is a reissue application of U.S. Pat. No. 8,974,485 which issued on Mar. 10, 2015 from U.S. application Ser. No. 14/280,277 filed on May 16, 2014, entitled “GUIDEWIRE AND METHOD FOR SURGICAL PROECURES’, which claims priority as a continuation of U.S. patent application Ser. No. 13/973,677; filed Aug. 22, 2013, entitled, “GUIDEWIRE AND METHOD FOR SURGICAL PROCEDURES”, now U.S. Pat. No. 8,728,111, issued May 20, 2014, which is a continuation-in-part to U.S. Non-Provisional application Ser. No. 13/722,667; filed Dec. 20, 2012, entitled, “GUIDEWIRE AND METHOD FOR SURGICAL PROCEDURES”, now U.S. Pat. No. 8,540,676, issued Sep. 24, 2013, which is a continuation-in-part to U.S. Non-Provisional application Ser. No. 13/037,947, filed Mar. 1, 2011, entitled, “GUIDEWIRE AND METHOD FOR SURGICAL PROCEDURES”, now U.S. Pat. No. 8,545,531, issued Oct. 1, 2013, which is a continuation-in-part of U.S. Non-Provisional Utility application Ser. No. 12/823,791, filed Jun. 25, 2010, entitled, “K-WIRE AND METHOD FOR SURGICAL PROCEDURES”, now U.S. Pat. No. 8,361,102, issued Jan. 29, 2013, which claims priority to U.S. Provisional 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.
FIELD OF INVENTIONThe present invention relates to an improved guide wire or K-wire for use in surgical procedures such as orthopedic procedures; and in particular, to spinal procedures such as percutaneous pedicle screw constructs.
BACKGROUND OF THE INVENTIONIn 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 generally used to form a hole through bone as a first step in certain medical procedures, such as attaching a screw to a pedicle. The K-wire, or guide wire, is inserted through the cannula of the jamshidi sheath into the interior of the bone. This procedure, if not completed 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 drill, tap, screw, screwdriver or the like 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 or through the surgical site; which, if excessive, can move into contact where contact is to be avoided.
A K-wire, or guide wire, includes a generally elongated cylindrical shape and has a preferred diameter of about 1.3 millimeters, although the diameter can vary depending on the procedure and hardware being utilized for the procedure. The cross sectional size and shape of the K-wire is limited only by the tools and devices it is used with. Each tool or device is typically 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 passage 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. The relatively small diameter, combined with a lack of impeded movement, allows movement during a surgical procedure. Such movement is often difficult to notice during a surgical procedure where vision is limited by fluids, tissue and/or bone, and may further require x-rays or the like to determine the position of the wire. 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 various solutions 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.
The present invention also provides easy removal of the K-wire, or guide wire, through traditional surgical tools and devices.
DESCRIPTION OF THE PRIOR ARTU.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 systems 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.
SUMMARYThe 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 opening 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, when 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.
Like numbers used throughout the figures designate like or similar parts and/or construction.
DETAILED DESCRIPTION OF THE INVENTIONWhile 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 tubular member 148 with a through bore 16 (as would a drill, tap or screw) and a removable and replaceable rod member 15 having a sharpened distal end 17. The rod member 15 is held in place within the through bore by threads or a bayonet mount (not shown) as is known in the art. A handle 18 may also be provided at the proximal end 20 of the tubular member 148 for facilitating insertion of the tubular member 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 tubular member 148 by striking the handle 18 with a hand or impact tool such as a hammer 149, as illustrated in
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 (
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 be freely movable therein. The K-wire, or guide wire, 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
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
In the embodiment shown in
In the embodiment shown in
The embodiments of the invention shown in
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.
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The present invention also includes a method of conducting a medical procedure using a K-wire, or guide wire, as illustrated in
Referring to
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.
Claims
1. A method of conducting a medical procedure on a surgical site using a guide wire, the method comprising the steps of:
- placing a surgical tool at a surgical site, said surgical tool having a guiding through bore which terminates in a distal end opening;
- passing a guide wire having a manipulative end, a center portion and an operative end through said guiding through bore, the guide wire being monolithic and bifurcating into two portions at the operative end, said operative end configured to be traversable between a first configuration and a second configuration configured to limit forward axial motion of said guide wire into said surgical site; and
- traversing said guide wire from said first configuration to said second configuration by passing said guide wire operative end beyond said opening of said through bore, said second configuration defined by said operative end having a deformed projected area that is greater than the cross sectional area of the guide wire when in said first configuration,
- wherein said two portions at the operative end includes are two equally sized deployable free ends which diverge from a common region of said guide wire, each said free end having a first linear portion and a second portion which diverges from the longitudinal axis of said guide wire at a bend, said bend positioned between said common region of said guide wire and a distal end of said free end, wherein each said bend is positioned at a predetermined location within said free end to provide a predetermined separation angle, wherein each said free end contains at least one bone or tissue engagement member.
2. The method of conducting a medical procedure on a surgical site using a guide wire according to claim 1 further including the step of traversing said guide wire from said second configuration to said first configuration by retracting said guide wire from said surgical site, whereby retracting said operative end from a position extending past said opening of said surgical tool to a position within said through bore results in a cross sectional area that is less than the area of said projected area when in said second configuration.
3. The method of conducting a medical procedure on a surgical site using a guide wire according to claim 1 wherein said treatment site is bone or bone tissue.
4. The method of conducting a medical procedure on a surgical site using a guide wire according to claim 1 wherein said tissue engagement member includes a plurality of teeth provided on an inner surface of the free end.
5. The method of conducting a medical procedure on a surgical site using a guide wire according to claim 1 wherein said bend of each said free end is positioned closer to said distal end of said free end.
6. The method of conducting a medical procedure on a surgical site using a guide wire according to claim 1 wherein said bend of each said free end is positioned closer to said point where said free ends diverge from a common region of said guide wire.
7. The method of conducting a medical procedure on a surgical site using a guide wire according to claim 1 wherein each said bend is positioned at a predetermined location within said free ends to provide an angle of at least 30 degrees.
8. The method of conducting a medical procedure on a surgical site using a guide wire according to claim 1 wherein each said bend is positioned at a predetermined location within said free ends to provide an angle of at least 50 degrees.
9. The method of conducting a medical procedure on a surgical site using a guide wire according to claim 1 wherein each said free end is constructed from a flexible material.
10. The method of conducting a medical procedure on a surgical site using a guide wire according to claim 1 wherein each said free end is constructed from a memory metal alloy.
11. The method of conducting a medical procedure on a surgical site using a guide wire according to claim 1 wherein said memory metal alloy is a super-elastic material.
12. The method of conducting a medical procedure on a surgical site using a guide wire according to claim 1 wherein the memory metal alloy includes Nitinol.
13. The method of conducting a medical procedure on a surgical site using a guide wire according to claim 1 wherein each said deployable end is constructed from a memory metal alloy.
14. The method of conducting a medical procedure on a surgical site using a guide wire according to claim 1 wherein each said deployable end is constructed of a resiliently deformable spring material.
15. The method of conducting a medical procedure on a surgical site using a guide wire according to claim 1 wherein each said deployable end has a deformable portion made of a plastically deformable material.
16. The method of conducting a medical procedure on a surgical site using a guide wire according to claim 1 wherein each said free end is self deployable.
17. The method of conducting a medical procedure on a surgical site using a guide wire according to claim 1 wherein the surgical site is a vertebral body.
18. A method of conducting a spinal procedure using a guide wire comprising the steps of:
- placing a surgical tool at a vertebral body, the surgical tool having a guiding through bore which terminates at a distal end opening;
- passing a guide wire having a manipulative end, a center portion and an operative end through the guiding through bore, the guide wire being monolithic and bifurcating into two portions at the operative end, the operative end being in a first configuration while in the through bore; and
- manipulating the manipulative end to pass the operative end beyond the distal end opening, the operative end being in a second configuration outside of the through bore,
- wherein the second configuration of the operative end is configured to limit movement of the guide wire in the vertebral body.
19. The method of claim 18, wherein a projected area of the operative end is greater in the second configuration than in the first configuration.
20. The method of claim 18, wherein the two portions at the operative end are two equally sized deployable free ends which diverge from a common region of the guide wire, each free end having a first linear portion and a second portion which diverges from the longitudinal axis of said guide wire at a bend, wherein each said bend is positioned at a predetermined location to provide a predetermined separation angle between the first and second linear portions in the second position.
21. The method of claim 18, further including the step of moving the operative end from the second configuration to the first configuration by retracting the operative end at least partially into the through bore.
22. The method of claim 18, further including the step of removing the surgical tool by pulling on the surgical tool and pushing down on the guide wire.
23. The method of claim 18, 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.
24. The method of claim 20, wherein each free end includes at least one bone or tissue engagement member.
25. The method of claim 24, wherein the bone or tissue engagement members are teeth.
26. The method of claim 20, wherein the bends are positioned at a predetermined location such that the separation angle is at least 30 degrees.
27. The method of claim 20, wherein the bends are positioned at a predetermined location such that the separation angle is at least 50 degrees.
28. The method of claim 20, wherein each free end is constructed from a flexible material.
29. The method of claim 20, wherein each free end is constructed from a memory metal alloy.
30. The method of claim 29, wherein the memory metal alloy is a super-elastic material.
31. The method of claim 29, wherein said memory metal alloy includes Nitinol.
32. The method of claim 20, wherein each free end is constructed from a rigid material.
33. The method of claim 20, wherein each free end is constructed of a resiliently deformable spring material.
34. The method of claim 20, wherein each free end has a deformable portion made of a plastically deformable material.
35. The method of claim 20, wherein each free end is self deployable.
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Type: Grant
Filed: Mar 9, 2017
Date of Patent: May 29, 2018
Assignee: Orthovita, Inc. (Malvern, PA)
Inventors: Wyatt Drake Geist (Davie, FL), Arden Allen Geist, Sr. (Indialantic, FL)
Primary Examiner: Beverly M Flanagan
Application Number: 15/454,638
International Classification: A61M 29/00 (20060101); A61B 17/17 (20060101); A61B 17/88 (20060101);