This disclosure relates generally to medical devices, and more specifically to devices and methods for a biplanar wedge osteotomy.
Patients with Charcot neuropathy may experience swelling, and joint subluxation (dislocation). Eventually, the mal-positioning of the joints can result in a bony prominence beneath the foot. Patients with neuropathy may not experience pain, and may continue to walk and bear weight on the affected foot. If left untreated, ulceration and infection may result. Treatment goals include allowing the ulcers to heal, creating a plantagrade foot, and preventing infection.
“Meary's angle” is one measure of the deformity of the foot. Meary's angle is the angle between the central longitudinal axis of the talus and the central longitudinal axis of the first metatarsal, as viewed in a vertical (parasagittal) plane. In a normal foot, Meary's angle is 0 degrees. In the case of a Charcot foot, Meary's angle can reach 15-30 degrees or more.
To eliminate the bony prominence and restore the arch in patients with severe Charcot deformity affecting multiple foot joints, surgeons have performed a biplanar wedge osteotomy. In this procedure, the surgeon removes a biplanar wedge of bone from the plantar side of the foot. By rejoining the remaining bones, the surgeon is able to restore the foot into a stable plantagrade foot that can fit in a shoe and can support activity with proper bracing. Thus, the surgeon tries to reduce Meary's angle to approximately zero (i.e., between zero and four degrees).
In some embodiments, a method for bi-planar wedge osteotomy of a foot comprises the steps of: (a) inserting a first wire at least into a first bone of the foot, so that the first wire is distal from tissue to be removed; (b) inserting a second wire into a second bone of the foot, so that the tissue to be removed is distal from the second wire; (c) pivoting a cut guide about the first wire, until a first axis of the cut guide is parallel with a longitudinal axis of a first metatarsal of the foot, the cut guide having a slot perpendicular to the first axis of the cut guide for guiding a cutter; (d) cutting bone through the slot while the first axis of the cut guide is aligned with the longitudinal axis of the first metatarsal; (e) pivoting the cut guide about the second wire, until the first axis of the cut guide is aligned with the longitudinal axis of the talus; and (f) cutting bone through the slot while the first axis of the cut guide is aligned with the longitudinal axis of the talus, to form a second planar cut into or through bone material.
In some embodiments, a method for bi-planar wedge osteotomy of a foot comprises the steps of: inserting a first wire at least into a first bone of the foot, so that the first wire is distal from tissue to be removed; inserting a second wire into a second bone of the foot, so that the tissue to be removed is distal from the second wire; pivoting a cut guide about the first wire, until a first axis of the cut guide is parallel with a longitudinal axis of a first metatarsal of the foot, the cut guide having a slot perpendicular to the first axis of the cut guide for guiding a cutter; inserting a third wire through the cut guide, so as to fix the cut guide to the first bone while the first axis of the cut guide is aligned with the longitudinal axis of the first metatarsal; cutting bone through the slot while the cut guide is fixed by the first and third wires, to form a first planar cut into or through bone material; pivoting the cut guide about the second wire, until the first axis of the cut guide is aligned with the longitudinal axis of the talus; inserting a fourth wire through the cut guide, so as to fix the cut guide to the second bone while the first axis of the cut guide is aligned with the longitudinal axis of the talus; and cutting bone through the slot while the cut guide is fixed by the second and fourth wires, to form a second planar cut into or through bone material.
In some embodiments, a cut guide comprises a body having a first face, a second face opposite the first face, and a straight slot therethrough for guiding a blade, the slot extending from the first face to the second face. The body has a row of holes extending therethrough from the first face to the second face, the row of holes being parallel to the slot. The body has an alignment opening extending parallel to the first face, the alignment opening perpendicular to the slot, the alignment opening configured to receive a radiopaque member therethrough.
This description of the exemplary embodiments is intended to be read in connection with the accompanying drawings, which are to be considered part of the entire written description. In the description, relative terms such as “lower,” “upper,” “horizontal,” “vertical,”, “above,” “below,” “up,” “down,” “top” and “bottom” as well as derivative thereof (e.g., “horizontally,” “downwardly,” “upwardly,” etc.) should be construed to refer to the orientation as then described or as shown in the drawing under discussion. These relative terms are for convenience of description and do not require that the apparatus be constructed or operated in a particular orientation. Terms concerning attachments, coupling and the like, such as “connected” and “interconnected,” refer to a relationship wherein structures are secured or attached to one another either directly or indirectly through intervening structures, as well as both movable or rigid attachments or relationships, unless expressly described otherwise.
Unless otherwise indicated, like reference numerals in different drawings indicate like structures.
This disclosure provides a cut guide and a method of using the cut guide, for a compound angle osteotomy, such as a biplanar medial column osteotomy. The method and cut guide enable a surgeon to consistently align the two planar cuts of the foot bones to restore a plantigrade structure and substantially reduce Meary's angle.
The body 102 has a row of holes 108a-108f extending therethrough from the first face 110 to the second face 112. The row of holes 108a-108f is parallel to the slot 104. The holes 108a-108f can be sized to receive wires or pins to be used during a surgical procedure, such as a 2.4 mm k-wire. In some embodiments, six holes 108a-108f are provided at evenly spaced intervals. Other embodiments can include any integer number of holes greater than or equal to two. Providing more than two holes allows the surgeon flexibility to locate healthy bone into which he/she can insert a k-wire securely for fixing the cut guide in the proper orientation to make the cuts for the wedge osteotomy.
In some embodiments, the body 102 has an alignment opening 106 extending parallel to the first face 110. A first axis 109 of the cut guide coincides with the central longitudinal axis of the alignment opening 106. The alignment opening 106 is perpendicular to the slot 102. The alignment opening 106 is configured to receive a radiopaque member therethrough. For example, the radiopaque member can be made of a metal, such as stainless steel. In some embodiments, the alignment opening 106 is a smooth through-hole for receiving a k-wire.
In other embodiments (not shown), the alignment opening 106 is threaded, to receive a threaded member. In other embodiments (not shown), instead of the alignment opening 104, the body has a unitary elongated alignment member projecting outward from the body; for example, the entire body, including the alignment member, can be made of a radiopaque material.
In some embodiments, the cut guide 100 is made of stainless steel, such as an ASTM A564-630 steel.
When viewed from the superior view, as shown in
In a normal foot, the longitudinal axis 234 of the 2nd metatarsal 209 is in line with the longitudinal axis 236 off the talus, when viewed in the superior view. The example of
In some embodiments, the first wire 221 is positioned, so a projection of the first wire 221 in a transverse plane of the foot is approximately perpendicular to a longitudinal axis 234 of a second metatarsal 209 of the foot 200. In some embodiments, a projection of the second wire 222 in the transverse plane is approximately perpendicular to a longitudinal axis 236 of a talus 204.
As shown in
The surgeon inserts a straight elongated member 220 through the alignment opening 106 extending through the cut guide 100. Since the alignment opening 106 is perpendicular to the slot 104, the elongated member 220 is perpendicular to the slot 104 following insertion. Because of its length, the elongated member 220 makes it easy to detect whether the cut guide deviates from alignment parallel to the longitudinal axis of the first metatarsal (when making the first cut) or the talus (when making the second cut). The elongated member 220 is external to the foot 200 at all times during the procedure.
The surgeon pivots the cut guide 100 about the first wire 221, until a first axis 109 of the cut guide (coinciding with the longitudinal axis of the alignment opening 106 and the longitudinal axis of the elongated member 220) is parallel with a longitudinal axis 238 of the first metatarsal 208 of the foot 200. Since the slot 104 of the cut guide 100 is perpendicular to the first axis 109 of the cut guide, the step of aligning the elongated member 220 with the longitudinal axis of the first metatarsal 208 orients the slot 104 perpendicular to the longitudinal axis 238 of the first metatarsal 208 for guiding a cutter 240.
In some embodiments, the elongated member 220 is radiopaque, and the surgeon views the first metatarsal 208 and the elongated member 220 by fluoroscopy while aligning the elongated member 220 with the longitudinal axis of the first metatarsal 238. In some embodiments, the elongated metal member slidably or threadably engages the alignment opening. For example, the elongated member 220 can be a stainless steel k-wire.
As shown in
After completing the first cut, the surgeon can remove the cut guide 100.
The surgeon re-inserts the elongated member 220 through the alignment opening 106 extending through the cut guide 100. As shown in
The surgeon pivots the cut guide 100 about the second wire 222, until the first axis 109 of the cut guide 100 is aligned with the longitudinal axis 239 of the talus 204 (i.e., until the elongated member 220 is aligned with the longitudinal axis of the talus.).
As shown in
As shown in
After completing the second cut, the surgeon can remove the cut guide 100.
As shown in
The methods described above decouple the two planar cuts of the wedge osteotomy, allowing the surgeon to consistently remove the bone material that has dropped down and is likely to cause repeated ulceration, while keeping the bone at the top of the foot. Although the examples provided above use the cut guide to perform a wedge osteotomy in the mid-foot, the cut guide can also be used for performing a wedge osteotomy in the tibia.
Although the subject matter has been described in terms of exemplary embodiments, it is not limited thereto. Rather, the appended claims should be construed broadly, to include other variants and embodiments, which may be made by those skilled in the art.
This application is a continuation of U.S. patent application Ser. No. 14/842,944, filed on Sep. 2, 2015, the entirety of which is herein incorporated by reference.
Number | Name | Date | Kind |
---|---|---|---|
5540695 | Levy | Jul 1996 | A |
5601565 | Huebner | Feb 1997 | A |
5676668 | McCue et al. | Oct 1997 | A |
5722978 | Jenkins, Jr. | Mar 1998 | A |
5843085 | Graser | Dec 1998 | A |
7083624 | Irving | Aug 2006 | B2 |
8083746 | Novak | Dec 2011 | B2 |
8182489 | Horacek | May 2012 | B2 |
8496662 | Novak et al. | Jul 2013 | B2 |
8784498 | Scheland | Jul 2014 | B2 |
8888785 | Kmmann et al. | Nov 2014 | B2 |
9005207 | Dodds et al. | Apr 2015 | B2 |
9060822 | Lewis et al. | Jun 2015 | B2 |
9492183 | Wilkinson et al. | Nov 2016 | B2 |
20050273112 | McNamara | Dec 2005 | A1 |
20070233138 | Figueroa et al. | Oct 2007 | A1 |
20070233145 | Richardson et al. | Oct 2007 | A1 |
20100217328 | Terrill | Aug 2010 | A1 |
20100256638 | Tyber | Oct 2010 | A1 |
20110172672 | Dubeau et al. | Jul 2011 | A1 |
20110218540 | Ammann | Sep 2011 | A1 |
20130204261 | Eschle et al. | Aug 2013 | A1 |
20140180341 | Kang et al. | Jun 2014 | A1 |
Number | Date | Country |
---|---|---|
102781348 | Nov 2012 | CN |
2092899 | Aug 2009 | EP |
2790380 | Sep 2000 | FR |
200729657 | Feb 2007 | JP |
2013540012 | Oct 2013 | JP |
2003063682 | Aug 2003 | WO |
2010025183 | Mar 2010 | WO |
2011063281 | May 2011 | WO |
2012106477 | Aug 2012 | WO |
2015003284 | Jul 2014 | WO |
2014152535 | Sep 2014 | WO |
2015105880 | Jul 2015 | WO |
Entry |
---|
Examination Report No. 2 issued in connection with corresponding Australian Patent Application No. 2018204463, dated Jun. 28, 2019, 8 pages. |
Second Office Action issued in connection with corresponding Chinese Patent Application No. 201610170261.7, dated Jun. 13, 2019, 6 pages. |
Sammarco, V.J. et al., “Midtarsal Arthrodesis in the Treatment of Charcot Midfoot Arthropathy”, J. Bone Joint Surg Am., Jan. 2009, 91:80-91. |
Grant, W.P. et al., “A Retrospective Analysis of 50 Consecutive Charcot Diabetic Salvage Reconstructions”, The Journal of Foot & Ankle Surgery, Jan./Feb. 2009, 48(1):30-308. |
Assal, M. et al., “Realignment and Extended Fusion with Use of a Medial Column Screw for Midfoot Deformities Secondary to Diabetic Neuropathy: Surgical Technique”, J Bone Joint Surg Am., Mar. 2010, 92:20-31. |
Scott, Ryan T., et al., “Osteotomies for the Management of Charcot Neuroarthropathy of the Foot and Ankle”, Clin Podiatr Med Surg, Jul. 2015, 32(3):405-418. |
McAlister, J.E. and Philbin, T. M., “A Closer Look At the Distal Tibial Osteotomy for Ankle Varus”, Podiatry Today, Oct. 29, 2012, 25(11)1-4. |
European Search Report and Search Opinion issued for corresponding European patent application No. 16161879.8, dated Jan. 18, 2017, 7 pages. |
Office Action issued for corresponding Canadian patent application No. 2,924,441, dated Mar. 28, 2017, 3 pages. |
Zhou, Y. et al. “A Prospective Study of Midfoot Osteotomy Combined with Adjacent Joint Sparing Internal Fixation in Treatment of Rigid Pes Cavus Deformity”, Journal of Orthopaedic Surgery and Research, Jun. 2014, 9:44, pp. 1-5. |
Salvation 3Di Plating System Surgical Technique, pp. 1-20, [retrieved from Internet on Apr. 24, 2017] <URL: http://www.wmtemedia.com/ProductFiles/Files/PDFs/009722_EN_LR_LE_pdf>. |
Examination Report No. 1 issued for corresponding Australian patent application No. 2016201813, dated Apr. 24, 2017, 10 pages. |
Office Action issued in corresponding Japanese patent application No. 2016-058237, dated Jun. 27, 2017, 2 pages. |
Office Action issued in connection with corresponding Canadian patent application No. 2,924,441, dated Dec. 11, 2017 5 pages. |
Office Action issued in connection with corresponding European patent application No. 16161879.8, dated Mar. 26, 2018, 5 pages. |
Examination Report No. 2 issued for corresponding Australian patent application No. 2016201813, dated Aug. 29, 2017, 4 pages. |
Examination Report No. 1 issued in connection with corresponding Australian Patent Application No. 2020200968, dated Jul. 17, 2020, 4 pages. |
First Office Action issued in connection with corresponding Canadian Patent Application No. 3,033,607, dated Feb. 3, 2020, 5 pages. |
Office Action issued in corresponding Chinese Patent Application No. 201610170261.7, dated Aug. 2, 2018, 6 pages. |
Number | Date | Country | |
---|---|---|---|
20180317942 A1 | Nov 2018 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 14842944 | Sep 2015 | US |
Child | 16036980 | US |