united states patent no. 9, b2 kay date...

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IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII US009259253B2 lI2~ United States Patent Kay et al. (10) Patent No. : US 9, 259, 253 B2 (45) Date of Patent: *Feb. 16, 2016 (54) ORTHOPEDIC PLATE FOR USE IN SMALL BONE REPAIR ( * ) Notice: Subject to any disclaimer, the term of this patent is extended or adjusted under 35 U. S. C. 154(b) by 0 days. (71) Applicant: ORTHOHELIX SURGICAL DESIGNS, INC. , Medina, OH (US) (72) Inventors: David B. Kay, Akron, OH (US); Lee A. Strnad, Broadview Hts. , OH (US); Dustin Ducharme, Stow, OH (US); G. Martin Wynkoop, Gainesville, FL (US) (73) Assignee: ORTHOHELIX SURGICAL DESIGNS, INC. , Medina, OH (US) (56) References Cited U. S. PATENT DOCUMENTS 2, 526, 959 A 10/1950 Lorenzo 3,716,050 A 2/1973 Johnston (Continued) FOREIGN PATENT DOCUMENTS (2013. 01); A61B 17/8085 (2013. 01); A6/B /7/56 (2013. 01); A6/B /7/8004 (2013. 01); A6/B /7/885 (2013. 01) (58) Field of ClassiTication Search CPC ........... A61B 17/8004; A61B 17/8085; A61B 17/8061 See application file for complete search history. This patent is subject to a terminal dis- claimer. CH DE 611147 AS 5/1979 20309361 Ul 5/1979 (21) Appl. Noz 14/230, 263 (22) Filed: Mar. 31, 2014 (65) Prior Publication Data US 2014/0296923 Al Oct. 2, 2014 Related U. S. Application Data (60) Continuation of application No. 13/348, 888, filed on Jan. 12, 2012, now Pat. No. 9, 144, 443, which is a division of application No. 12/380, 177, filed on Feb. 24, 2009, now Pat. No. 8, 118, 846, which is a (Continued) (51) Int. Cl. A61B 17/80 (2006.01) A6/B /7/88 (2006.01) A6/B /7/56 (2006.01) (52) U. S. Cl. CPC ......... A61B 17/8061 (2013. 01); A61B 17/8057 (Continued) OTHER PUBLICATIONS Locking Clavicle Plate System byACUMEDlR1, Brochure, 7 pages, Jul. 2005. (Continued) Primary Examiner Ellen C Hammond (74) Attorney, Agent, orFirm Hudak, Shunk8'cFarineCo. LPA (57) ABSTRACT The present invention relates to a series of orthopedic plates for use in repair of a bone. The plate has a Y-shaped profile or an X-shaped profile which includes an elongate central trunk with a complex contour and either one or two terminal pairs of arms that have a first arm and a second arm that form differing angles and lengths relative to the trunk portion of the plate. The arms include locking screw holes where the screws con- verge toward each other to provide for multiplanar fixation but which do not impinge. 53 Claims, 10 Drawing Sheets Ex. 1004 P28 v. WMT Page 1

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Page 1: United States Patent No. 9, B2 Kay Date B.knobbemedical.com/wp-content/uploads/2019/04/US-Patent-No.-1.pdfUS 9,259,253 B2 1 ORTHOPEDIC PLATE FOR USE IN SMALL BONE REPAIR CROSS-REFERENCE

IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIUS009259253B2

lI2~ United States PatentKay et al.

(10) Patent No. : US 9,259,253 B2(45) Date of Patent: *Feb. 16, 2016

(54) ORTHOPEDIC PLATE FOR USE IN SMALLBONE REPAIR

( * ) Notice: Subject to any disclaimer, the term of thispatent is extended or adjusted under 35U.S.C. 154(b) by 0 days.

(71) Applicant: ORTHOHELIX SURGICALDESIGNS, INC. , Medina, OH (US)

(72) Inventors: David B.Kay, Akron, OH (US); Lee A.Strnad, Broadview Hts. , OH (US);Dustin Ducharme, Stow, OH (US); G.Martin Wynkoop, Gainesville, FL (US)

(73) Assignee: ORTHOHELIX SURGICALDESIGNS, INC. , Medina, OH (US)

(56) References Cited

U.S. PATENT DOCUMENTS

2,526,959 A 10/1950 Lorenzo3,716,050 A 2/1973 Johnston

(Continued)

FOREIGN PATENT DOCUMENTS

(2013.01);A61B 17/8085 (2013.01);A6/B/7/56 (2013.01);A6/B /7/8004 (2013.01);

A6/B /7/885 (2013.01)(58) Field of ClassiTication Search

CPC ........... A61B 17/8004; A61B 17/8085; A61B17/8061

See application file for complete search history.

This patent is subject to a terminal dis-claimer.

CHDE

611147 AS 5/197920309361 Ul 5/1979

(21) Appl. Noz 14/230, 263

(22) Filed: Mar. 31, 2014

(65) Prior Publication Data

US 2014/0296923 Al Oct. 2, 2014

Related U.S.Application Data

(60) Continuation of application No. 13/348, 888, filed onJan. 12, 2012, now Pat. No. 9,144,443, which is adivision of application No. 12/380, 177, filed on Feb.24, 2009, now Pat. No. 8,118,846, which is a

(Continued)

(51) Int. Cl.A61B 17/80 (2006.01)A6/B /7/88 (2006.01)A6/B /7/56 (2006.01)

(52) U.S. Cl.CPC ......... A61B 17/8061 (2013.01);A61B 17/8057

(Continued)

OTHER PUBLICATIONS

Locking Clavicle Plate System byACUMEDlR1, Brochure, 7 pages,Jul. 2005.

(Continued)

Primary Examiner Ellen C Hammond

(74) Attorney, Agent, orFirm Hudak, Shunk8'cFarineCo.LPA

(57) ABSTRACT

The present invention relates to a series of orthopedic platesfor use in repair of a bone. The plate has a Y-shaped profile oran X-shaped profile which includes an elongate central trunkwith a complex contour and either one or two terminal pairs ofarms that have a first arm and a second arm that form differingangles and lengths relative to the trunk portion of the plate.The arms include locking screw holes where the screws con-verge toward each other to provide for multiplanar fixationbut which do not impinge.

53 Claims, 10 Drawing Sheets

Ex. 1004 P28 v. WMT

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US 9,259,253 B2Page 2

(56) References Cited

U.S. PATENT DOCUMENTS

4,867, 1444,903,6915,304, 1805,324,2905,569,2505,681,3115,690,6315,718,7055,749,8725,766, 1755,853,4136,030,3896,096,0406, 123,7096,283,969D449,6926,358,2506,454,7696,527,7766,565,5706,575,9756,585,7696,623,486D520,6377,052,4997, 108,6977, 128,7447, 166,1117,341,5897,771,4577,776,0767,799,0618, 118,8468, 118,848

2003/01998752004/01931632005/00150892005/01077952005/02160082006/0129151

A 9/1989A * 2/1990A 4/1994A 6/1994A 10/1996A 10/1997A 11/1997A 2/1998A 5/1998A 6/1998A 12/1998A 2/2000A 8/2000A 9/2000BI * 9/2001S 10/2001BI 3/2002B2 9/2002BI 3/2003B2 5/2003B2 6/2003BI 7/2003BI 9/2003S 5/2006B2 5/2006B2 9/2006B2 10/2006B2 I/2007B2 3/2008B2 * 8/2010B2 8/2010B2 * 9/2010B2 * 2/2012B2 * 2/2012A I 10/2003Al 9/2004Al I/2005Al 5/2005Al 9/2005Al 6/2006

Karas et al.HeinlSlocumZdeblick et al.Sarver et al.Foley et al.Duncan et al.SammarcoKyle et al.MartinottiCarter et al.Wagner et al.EsserJones et al.Grusin et al.MichelsonOrbayWagner et al.MichelsonSterett et al.Brace et al.Muhanna et al.Weaver et al.Kay et al.Steger et al.Mingozzi et al.Weaver et al.Kolb et al.Weaver et al.Kay et alGrady et alKay et alLeither et al. .. ... .Ducharme et al. .Mingozzi et al.OrbayYoung et al.Morris et al.Myerson et al.Allen et al.

.. . 606/70

. .. 606/280

. .. 606/284

... .. 606/283

... .. 606/280

... .. 606/291

Related U.S.Application Data

continuation-in-part of application No. 11/340, 028,filed on Jan. 26, 2006, now Pat. No. 7,771,457.

(60) Provisional application No. 60/648, 364, filed on Jan.28, 2005.

2006/0161158 Al2006/0173458 Al2006/0173459 Al2006/0200145 Al2006/0212035 Al2006/0235411 Al2006/0241608 Al2007/0043366 Al2007/0073298 Al2007/0123883 Al2007/0173840 Al2007/0185493 Al2007/0233106 Al2007/0233112 Al2007/0270850 Al2008/0051786 Al2008/0300632 Al2008/0300637 Al

7/20068/20068/20069/20069/2006

10/200610/20062/20073/20075/20077/20078/2007

10/200710/200711/20072/2008

12/200812/2008

Orbay et al.Forstein et al.Kay et al.Kay et al.Wotton, HIBlain et al.Myerson et al.Pfefferle et al.Beutter et al.Ellis et al.HuebnerFeibel et al.Horan et al.Orbay et al.GeisslerJensenButler et al.Austin et al.

FOREIGN PATENT DOCUMENTS

EPFRFRFRFRJPWOWOWO

1468655 A22233973 Al2405062 Al2405705 Al2405706 Al

1129980402096309 Al

2004086990 Al2008064211 Al

10/20042/19756/19796/19796/1979

11/199212/200210/20045/2008

OTHER PUBLICATIONS

* cited by examiner

3.5 mm LCP Superior Anterior Clavicle Plates. Part of the Small

Fragment Locking Compression Plate iLCP1 System by

SYNTHES(Ri, Technique guide brochure, 24 pages, Sep. 2008.Clavicle Locking Plate by Smith & Nephew PERI-LOC LockedPlating System, Brochure, 16 pages, May 2007.Locking Bone Plate System for Hallux Valgus corrections "Openingor Closing Base Wedge" Osteotomy by MetaFix iTM1 and

mereteiR1, Brochure, 2 pages, Feb. 2005.Dr. Michael Stephens, M.D., HALLIJiR1-S PLATE by IntegraiTM1,Pamphlet, 6 pages, Jan. 2005.TOMiTM1-Platte by DARCOiR1, Pamphlet, 2 pages, Dec. 8, 2006.New Trauma Products from AO Development, Catalog, 2 pages, Jun.2006.Reconstructive Surgery, IntegraiTM1, Product Catalog, 4 pagesincluding new dealiR1, New ideas for foot surgeryiTM1, 2005.

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US 9,259,253 B21

ORTHOPEDIC PLATE FOR USE IN SMALLBONE REPAIR

CROSS-REFERENCE

This application is continuation application of pendingU.S. patent application Ser. No. 13/348, 888, filed on Jan. 12,2012 for ORTHOPEDIC PLATES FOR USE IN CLAVICLEREPAIR AND METHODS FOR THEIR USE which is adivisional ofU.S.Pat. No. 8,118,846, issued on Feb. 21, 2012for ORTHOPEDIC PLATES FOR USE IN CLAVICLEREPAIR AND METHODS FOR THEIR USE which is a CIPof U.S. Pat. No. 7,771,457, issued on Aug. 10, 2010 forORTHOPEDIC PLATE FOR USE IN SMALL BONEREPAIR which claimed priority to U S. Provisional Applica-tion Ser. No. 60/648, 364 filed on Jan. 28, 2005 for ORTHO-PEDIC PLATE FOR USE IN SMALL BONE REPAIR.

FIELD OF THE INVENTION

The present invention relates to orthopedic plates in par-ticular for surgical repairs or reconstruction of a clavicle andto a method for the use of these plates.

BACKGROUND OF THE INVENTION

The field of orthopedic medicine has grown tremendouslyin the past fifty years as surgical techniques, implants andinstrumentation have developed and been improved. Thesmall bones are frequently subject to the need for re-construc-tive surgery for example, as a result of trauma, to counteractthe effects of aging or to repair congenital deformities andtrauma and spinal areas. While there is a wide variety in theexact shape and mass of all bones, these variations becomemore problematic in providing orthopedic implants for smallbone applications since there is less room on and about thebone for the surgeon to place and fix the construct. Thesebones are finer and have less surface area for placement of animplant, have less mass for the placement of screws and areoften surrounded by less muscle and by more vulnerabletendons, blood vessels and nerves. As a result, individualvariations become more problematic for orthopedic plates ofstock design. Consequently, surgeons have tended to rely onthe use of screws and wires for reconstruction or have had toresort to operating room contouring procedures which canweaken the plates and/or distort the screw holes within theplates. This is a particular problem in instances in whicheither variable locking mechanisms are used, or in whichlocking screws are used with the plates. None-the-less, lock-ing screws often are used to advantage as they provide moresecure placement of the screws in the bone, cause bettercompression through a fractures, and are less likely to harmthe bone or back out of the plate.

One problem that needs to be avoided in the delicate envi-ronment of the small bone area is the interference of screws,with other screws, and with the function of ligaments andtendons. While it may be desirable to design an orthopedicplate so that securing screws converge in order to cause com-pression or increase the pullout strength, it is difficult when ascrew impinges on or conflicts with the desired placement ofanother screw. Some surgeons prefer bicortical fixation inwhich a screw is sized so that the distil end is secured incortical bone giving the screw better purchase, however, othersurgeons may prefer to avoid placing a screw so that itprojects beyond the outer surface of the anchoring bone.These factors are complicated by the relative lack of softtissue and the presence of ligaments and tendons in the small

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bone areas. Consequently, the less forgiving biological envi-ronment in which the small bone surgeon works requiresgreater procedural precision and calls for specializedimplants and tools.

The present invention is designed to meet the specificneeds of the small bone surgeon to facilitate effective andrepeatable procedures which provide for ease of use and arange of function for this specific area of specialization. Thepresent invention is specifically intended to provide for thetreatment of fracture repair following trauma in an otherwisehealthy individual where plates are used to maintain the integ-rity of the bones while they heal, although it is certainly

possible that they may also be used for other surgeries such asreconstruction to correct congenital or age related deforma-tion or issues that relate to prior mal-union of the bone fol-lowing a prior injury.

The plates of the present invention are designed specifi-cally for the repair or reconstruction of a clavicle, which iscommonly called a "collarbone". The collarbones, like thecheekbones, are covered only by skin, and thus have a highcorrelation to the appearance of the individuals and serve inmany cultures as a marker of beauty. These bones furtherserve to protect the brachial plexus and the medial nerve andblood vessels that are immediately internal to them. They alsoserve as a strut and the only skeletal connection between thearms and the torso, and they play a very sophisticated role inthe functioning of the shoulder girdle, torso, scapular and armkinesiology. The effect of misalignment and mal-union ofclavicle fractures are only recently being examined from theviewpoint of the strength and stamina of the patient as it waspreviously viewed radiographically and therefore underesti-mated.

It has been reported that as many as 5%of all fractures seenin the admissions department of an emergency room areclavicle fractures, which occur most commonly between theproximal t3 and the distal 13 of the bone. The more commonfracture (approximately 80% of clavicle fractures) occurs inthe middle third of the clavicle with an upward displacementof the proximal fragment of the bone by the sternocleidomas-toid muscle. The weight of the shoulder muscles and of theadductor muscles of the arm may add to the fragment dis-placement, causing the shoulder to droop. This type of frac-ture often occurs as a result of a fall on an outstretched handor of a direct blow to the clavicle. The second most commonfracture (which may account for 10-15%ofclavicle fractures)occurs in the distal 'ti of the clavicle. The causes of thefractures are similar to those for the mid-shaft fractures, butalso commonly include blows to the shoulder region, such asoccur in automobile collisions and particularly physicalsports such as hockey, lacrosse and football. Medial fracturesare often associated with very severe trauma that includesinjury to the vital organs and other indications of co-morbid-ity.

It is often difficult to reduce and subsequently to maintainthe reduction of clavicle fractures without surgical interven-tion, although both union and healing proceeds rapidly, usu-

ally with the result ofa prominent callus, and in some cases ofmal-union, with the possibility of medial cord nerve symp-toms. In the past, non-surgical treatment has often involvedimmobilization of the associated limb, such as in a figure-of-eight bandage or a simple sling. In a study published in theJournal of Bone and Joint Surgery, 2006 (88:35-40), byMcKee et al, Deficits Following Non-operative Treatment ofDisplaced Mid-shaft Clavicle Fractures, the authors in par-ticular note that that there was a substantial loss of strengthand endurance in clavicle fractures treated with a traditionalsling approach, indicating substantial residual disability

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despite apparently adequate range of motion. This and otherstudies have led to increased concern about providing widerrange of surgical options for internal stabilization of theclavicle. However, the problem remains that the shape andsize of clavicles vary greatly and their visibility leaves littleroom for plates that do not generally accommodate this varia-tion gracefully.

The present invention provides answers to the prior artissues by providing a variety ofplates with varying footprintsthat share an elongate central trunk with a medial line (whichis intended in this instance to include a curving line) thatdivides the plate in half laterally. The plate further has at leastone pair of terminal asymmetrical arms that extend from thetrunk at differing angles relative to the medial line and havediffering lengths. The plates also have varying profiles (orcontouring) in the z direction but again share a transversecurve along the medial line about the side which faces thebone. The plates also all exhibit bilateral asymmetry (mean-ing that the left half of the plate is not exactly the same as theright half of plate taken from the medial line) and they allachieve bi-planar screw fixation (meaning that the screws donot lie in a single plane). In addition, while the plates arepre-contoured, the plates are designed to facilitate threedimensional contouring (at least in the terminal arms) toaccommodate individual variation in bone shape. The platesare configured to bend laterally, longitudinally, and to wrap orspiral about the longitudinal axis or medial line so that theycan be molded to an optimal shape for small bone procedures.The plates are designed to provide optimal stabilization offractures and osteotomies by providing multi-planar fixationthat allows for better pull-out and limited axial loading to thebone. The plates are further designed to accelerate fusionsuccess by reducing or eliminating torsional or twistingstresses to the bone segments during the healing process. Inaddition, when desired, the plates can be shaped so as to applya compressive, or even a tensile, force, for example, along thelongitudinal axis of a bone.

These plates are provided in a number of variations in asurgical tray, which include for example various lengths ofthe central trunk portion, which is provided with a line ofscrew holes centered along the medial line. Further the num-ber of screw holes in the trunk can vary, and the type ofholescan vary to include translation slots, compression slots, andlocking and non-locking screw holes. Thus, the tray selectionallows the surgeon to select his plate during surgery afteropening the wound area and considering the plating needs. Inaddition, the tray includes plates of differing types for differ-ing placement on the clavicles. In a first embodiment of theclavicle plate of the present invention, a plate is provided forplacement on the superior aspect ofa clavicle, and in a secondembodiment, a plate is provided for placement on the ante-rior/inferior aspect of a clavicle, and in a third embodiment, aplate is provided for placement on the lateral aspect of aclavicle.

All of the plates have an elongate central trunk portionincluding one or more screw holes which are optionally sepa-rated by a waist shaped linking portion along a longitudinalaxis or the medial line and depending on the embodiment, theplate has one pair or two pairs of arms which are preferablyterminal to the central trunk, and which include screw holes(ke. one per arm) placed at an equal distance from the longi-tudinal axis but which diverge asymmetrically from the lon-gitudinal axis to avoid conflicts in the screw placement of thepaired arm, specifically, so that the screws of a set of armsavoid impinging on each other and further to provide multi-planar fixation at the plate terminus. The plate is curved aboutthe inferior surface, (ke. the surface which faces toward and

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which may, but does not have to fully contact the bone), witha curvature corresponding generally to the curvature ofa bonysurface. In most of the embodiments ofthe plate this contour-

ing is the result ofa blending ofone or more series of radiusesso that the plate may comprise a portion of a cylinder, orportions ofa cylinders, or in the event that the medial line alsodefines a longitudinal curve in the z axis, a portion ofa torroid.The pair of arms continue this curvature to spiral or wraparound the bone like a small portion of a double helix (ke.extending through an arc of less than about 50'). The screwholes within the arms are placed so that the angle of thelongitudinal axis ofthe screws converge inthedirectionofthedistil end of the screw. The screw holes are placed with thelongitudinal axis perpendicular to a tangent to the top surfaceof the arm with the effect that the longitudinal axes of thescrews converge in the direction of the distil end. The con-vergence of the screw holes increases the pull-out strength ofthe screws.

Further the screw holes are rounded and the correspondingmating heads ofthe screws are rounded and have a low profileso that the screws can be seated with their longitudinal axes ata variety of angles. Preferably, there is at least 20' of conicalrotation, and more preferably 25', and most preferably 30' ofconical rotation of the screw axis in relation to the longitudi-nal axis of the screw hole (ke. the longitudinal axis of thescrew can be rotated through a conical shape about the axis ofthe screw hole where the apex of the cone describes an angleof30').Alternatively and in many cases, preferably, the screwholes can include internal threads which mate with externalthreads on the head of the screws to cause locking of thescrews relative to the plate.

While the screws are at convergent angles, the screws typi-cally do not in fact impinge on each other, or conflict in theirplacement since each of the arms of the plate in a pair form adifferent angle to the central trunk so that the longitudinal axisofthe screws are offset from each other along the length oftheplate. The radiused configuration of the plate is designed toincrease operating room efficiency by facilitating commonlydesirable shapes while maintaining the required strength and

by permitting bending without deforming the screw holes.This results in making customization in anticipation or duringsurgery easier.

The surgical tray of the present invention further includes avariety of screws. The screws useful with the plate of thepresent invention are self-starting, self-tapping screwsincluding the option ofpartial or full cannulation. The screwsinclude a unique cutting end having multiple flutes, and pref-erably 2 or 3 flutes about a conical recess. The screws furtherinclude a partial taper of the inner diameter in the proximalend over the first several thread turns, for example over 2-8,and preferably over 3-5 turns in order to increase the fatiguelife of the screw as well as providing potential physiologicaladvantages in use. The screws further include a torque drivingrecess that may be a hexagon, a torx shape, or a modificationof a torx shape, i.e. a multilobe shape having from 3 to 12lobes, and preferably having 4 to 8 rounded recesses or lobes.The recess can be of a constant size in the direction of thelongitudinal axis, or can taper inward along the longitudinalaxis of the screw toward the bottom of the recess. The screwshave a low profile, head which is rounded at the junction ofthehead and the shaft, and also rounded from the maximumdiameter toward the top surface or the proximal end relative tothe insertion tip, which includes the torque driving recess.This rounded low profile head keeps the screw from havingany sharp projecting edges which could provide an irritation

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to the tissue in the vicinity of the plate and further seats in theplate so that no more than 10%by volume of the screw head

projects from the plate.The instruments for use with the system are well-balanced

and ergonomically designed with sufficiently long handles toplace the surgeon's hands outside of the line of radiation and

designed to reduce fatigue in the operating room.Depending on the intended placement of the plate, the

central trunk, and the plate itself includes a general topogra-

phy (Le. the contour in the z direction) designed to maximizethe fit on a variety of shapes and sizes of clavicle whileenabling, but reducing the need for individualized contour-

ing. This topography includes a c-shape lateral curve in thesuperior and 4-hole anterior plates, a fishtail (ke. having abroad curve in the direction of the bone-facing surface of theplate terminating in a short up-turned curve at the end of theplate) shape in the longer anterior plates. The lateral plate hasan S-curve of the medial line in the direction of the width ofthe plate. The plate system of the present invention is thus

designed to fit a range ofneeds ofthe surgeon operating on theclavicles to allow him or her to perfect a variety of techniquesusing a set of instruments and a customizable plate and screwconstruct.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top view of a first embodiment of an orthopedicplate in accordance with the invention;

FIG. 2 is a cross-section of the plate of FIG. 1 taken alongline 2-2;

FIG. 3 is a cross-section of the plate of FIG. 1 taken alongline 3-3;

FIG. 4 is a cross-section of the plate of FIG. 1 taken alongline 4-4;

FIG. 5 is a cross section of the plate of FIG. 1 taken alongline 5-5;

FIG. 6 is a perspective view of a screw used with thepresent system;

FIG. 7 is a perspective view of a locking screw used withthe present invention;

FIG. S is a top view of a first version of a second embodi-ment of the plate in accordance with the invention;

FIG. 9 is a cross section of the plate of FIG. S taken alongline 9-9;

FIG. 10 is a mirror version of the plate shown in FIG. S;FIG. 11is a cross section ofthe plate ofFIG. 10taken along

line 10-10;FIG. 12 is an end perspective of a left version of a third

embodiment of a plate in accordance with the invention forplacement on the anterior aspect of a clavicle;

FIG. 13 is a top view of the plate of FIG. 12;FIG. 14 is a right end view of the plate of FIG. 12;FIG. 15 is a right side view of the plate of FIG. 12;FIG. 16 is a cross section of the plate of FIG. 12 taken

across the width of the plate;FIG. 17 is view of the plate ofFIG. 12 placed on a clavicle;FIG. 1S is an end perspective of a left version of a fourth

embodiment of a plate in accordance with the invention forplacement on the anterior aspect of a clavicle;

FIG. 19 is a top view of the plate of FIG. 1S;FIG. 20 is a right end view of the plate of FIG. 1S;FIG. 21 is a right side view of the plate of FIG. 1S;FIG. 22 is a cross section ofthe plate ofFIG. 1Staken along

line 22-22;FIG. 23 is view of the plate ofFIG. 1Splaced on a clavicle;

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FIG. 24 is a top view ofa left version ofa fifth embodimentof a plate in accordance with the invention for placement onthe anterior aspect of a clavicle;

FIG. 25 is an end perspective of the plate of FIG. 24;FIG. 26 is a right end view of the plate of FIG. 24;FIG. 27 is a right side view of the plate of FIG. 24;FIG. 2S is a cross section of the plate ofFIG. 24 taken along

line 2S-2S;FIG. 29 is view of the plate ofFIG. 24 placed on a clavicle;FIG. 30 is an end perspective of a left version of a sixth

embodiment of a plate in accordance with the invention forplacement on the superior aspect of a clavicle;

FIG. 31 is a top view of the plate of FIG. 30;FIG. 32 is a right end view of the plate of FIG. 30;FIG. 33 is a right side view of the plate of FIG. 31;FIG. 34 is a cross section of the plate ofFIG. 30 taken along

line 34-34;FIG. 35 is view of the plate ofFIG. 30 placed on a clavicle;FIG. 36 is an end perspective of a left version of a seventh

embodiment of a plate in accordance with the invention forplacement on the superior aspect of a clavicle;

FIG. 37 is a top view of the plate of FIG. 36;FIG. 3S is a right end view of the plate of FIG. 36;FIG. 39 is a right side view of the plate of FIG. 36;FIG. 40 is a cross section of the plate ofFIG. 36 taken along

line 40-40;FIG. 41 is view of the plate ofFIG. 36 placed on a clavicle;FIG. 42 is an end perspective of a left version of an eighth

embodiment of a plate in accordance with the invention forplacement on the lateral aspect of a clavicle;

FIG. 43 is a top view of the plate of FIG. 42;FIG. 44 right end view of the plate of FIG. 42;FIG. 45 is a right side view of the plate of FIG. 42;FIG. 46 is an right end view of the plate of FIG. 42; andFIG. 47 is a view of the plate of FIG. 42 placed on a

clavicle.

DETAILED DESCRIPTION OF THE INVENTION

The plate 10 of the present invention is shown having abilaterally asymmetric shape with either one or two pairs oflegs extending from a central trunk portion 12 defining thelongitudinal axis of the plate. As shown the trunk portion 12includes two screw holes or slots 14 along the longitudinalaxis. However, as can be seen from FIGS. 12 through 1S theplate can be presented in a version which has a plurality ofscrew holes, for example up to 8 or more. The number ofscrew holes in the trunk portion 12 will depend on the lengthof the plate, and may range from 0 to 8, and more preferablyfrom 2 to 4. In one embodiment these holes are compressionholes or translation slots. The compression holes 14 are pref-erably slotted or elongated and optionally may have a largerradius area 11 on each of the screw holes facing in the samedirection, and a smaller radius area 13 in order to induce acompression toward the smaller radius end. The holes mayalso or alternatively have a shallow shoulder or lip 1S whichdescends toward the inferior surface of the plate to allow theplate to be set initially and subsequently to be slide into adifferent position as the screws are tightened down. Thisallows compression to be applied across the middle of thetrunk section. The plates include a visual indicator of thedirection of the compression, such as an arrow 17.Further, thescrew holes can include annular rings of increased thicknessin the vertical direction about through holes 14.

The through holes 14 in the trunk portion 12 have a longi-tudinal axis that is perpendicular to plane tangent to the topradius of the plate. The area linking the screw holes has a

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decreased width so as to define a waist area 26 that will bendlaterally (or "curve") relative to the longitudinal axis andwhich will bend longitudinally to form a curved area in andout of the plane of the plate. This thinner area also facilitatestwisting of the plate so as to allow the plate to spiral, or wraparound it longitudinal axis. The increased annular area aroundthe through bores resists deformation when a bending deviceis used to apply a force to the plate through the screw holes.

The plate 10 also includes at least one set of arms 20. Asviewed in FIG. 1, these sets of arms can be viewed as a set ofa short 22 and a long arm 23.Each ofthe arms in a set includesscrew holes 24 which are placed at a radially equal distancebut which diverging asymmetrically from the longitudinalaxis of the plate 10. More specifically, each set of armsincludes one arm that defines a smaller angle of divergence afrom the longitudinal axis of the trunk portion than the angleof divergence of the other arm J3. For example, the first angleshown in FIG. 1 at a may be from about 5' to about to 25', andmore preferably from about 10' to about to 20' and mostpreferably from about 12' to about to 16', while the secondangle shown at J3 from about 10' to about to 35', and more

preferably from about 15' to about to 30' and most preferablyfrom about 22' to about to 26' with a preferred difference inthe angles beings from about 2' to about to 20', and morepreferably from about 4' to about to 16' and most preferablyfrom about 8' to about to 12'.

In addition to the angled arms of this asymmetrical shapefacilitating a variety ofuseful positions in the small bone area,the plate of the present invention is sized to fit the needs of thesmall bone specialist. For small bone usage, the total length ofthe plate along its longitudinal axis is from about 25 mm toabout 80 mm, depending on the number of screw holes in thetrunk portion. The total width is from about 12 mm to about18 mm, with an inferior radius of curvature of about 8 mm toabout 12 mm and a concentric radius on the superior side.Typically, the waist area measures from about 7.5 mm toabout 10mm from the center of the larger, i.e. about 3.8 mm,radiused portion of the holes. The trunk portion has a width ofabout 7 mm to about 9 mm wide at the wider parts and about3 mm to about 5 mm wide at the narrower waist portion. Thelonger arm has a length along the longitudinal axis ofthe platefrom the center of the screw hole to the center of the plate fora two-hole trunk of from about 12 mm to about 16 mm, witha width of about 3 mm to about 5 mm. The shorter arm has acomparable length of from about 7 mm to about 15 mm witha narrowed width of about 2.5 to about 5 mm. In a furtherembodiment the plate could be modified for use in the longbones with a length ofup to about 400 mm with a width ofupto about 50 mm, and proportional sizes for the arms andthickness.

On the inferior side, or the side that would be facing (whichcontemplates opposing or touching or partially touching) thebone surface in use, the arms continue the radius of curvatureof the trunk portion. The superior or top side of the plate hasa similar radius of curvature as the top surface of the plate hasan outline that corresponds with the shape ofthe bottom of theplate (excluding the optional thickened annular area sur-

rounding the screw holes which would act to shield theseholes against deformation during bending. ) The screw holesalso include a rounded concavity to mate with the roundedshape of the head of the screw to allow of variable axispositioning. The screw holes 24 are placed with the longitu-dinal axis perpendicular a tangent to the top surface ofthe armwith the effect that the longitudinal axes of the screws con-verge in the direction of the distil end. This increases thepull-out strength of the plate/screw construct. Since the armsare asymmetrical relative to each other, and in particular since

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they diverge from the longitudinal axis of the trunk portion atdiffering angles, conflicts in the positions of paired screws isavoided so that the screws of a set of arms typically do notimpinge on each other. This is even more important ininstances where the plate is bent around the longitudinal axisso as to wrap around the longitudinal axis of the bone.

The arms 20 also each include a screw hole 24 which, likethe trunk portion 12 has a linking portion 26 that joins thescrew hole to the trunk portion. Again this design facilitatesthe desired bending while resisting deformation of the screwholes 24 when they are used with the bending instrument tocontour the plate. The angle of the arms 20 of each one of apair of arms (both top and bottom and right and left pairs)varies so as to create a bilateral asymmetry, meaning that theplate is not symmetrical with respect to a plane that passesthrough the longitudinal axis in the vertical direction from thesuperior (the top side relative to the bone) to the inferior side(the side facing the bone), the "first plane".

The screws holes of the trunk portion can include means toinduce a compressive force in one direction, such as a rampedarea on each screw hole. These ramped areas would beramped on the same side of the holes looking down from thetop of the plate. Typically the first screw implanted stabilizesand the second screw is used to achieve compression. Furtherthe length of each of the arms of a pair will vary so that theradial length of the center of the screw hole to the intersectionwith the longitudinal axis will be the same. As shown in FIGS.3-5, the plate includes a radial curve about the longitudinalaxis. The radius is typically about 10 mm with a transversedimension from the edge of one arm to the edge of the otherarm of a pair being about 15 or 16 mm for typical small boneusage, and the screw bore having a longitudinal axis of about24' to a plane passing through the longitudinal axis of theplate. The bores are typically about 3.75 mm for a 3.5 mmdiameter screw for small bones excluding the smallest ofapplications which would include phalanges. Again, for thesmallest application as well as long bone embodiments thescrews and corresponding screw holes could be sized to rangefrom a 1.5 mm diameter screw up to a 7.5 mm diameter screw.In a further embodiment, the bore could be threaded.

FIG. 6 shows a screw S1which could be used with the platesystem of the present invention. The distil end of the screwcan include a cutting tip which is self-starting and self-tap-

ping or a rounded blunt tip. This aspect is

defined

b a conicalrecess and a plurality offlutes. These screws S1 can optionallyinclude partial or full cannulation. The head of the screw S2 isspherical and includes a torque driving recess, such as amodified multilobe shape. The screw has a cancelleous threadS3 with a constant major diameter and a minor diameter thattapers proximally in order to increase fatigue life of the screwand to improve compression and compensate for bone resorp-tion. FIG. 7 shows a locking screw S6 which could be usedwith the present invention. The screw includes the same fea-tures as the screw in FIG. 6, except that the screw furtherincludes external threads SS on the screw head.

FIGS. S through 11 show a second embodiment of a platein accordance with the present invention in which the plateshown in FIG. 10 is a mirror image of the plate shown in FIG.S. In this embodiment, the plate 71, 71' has a Y-shape with anelongate and cylindrical central trunk having a single pair ofarms 72, 72' extending as previously described from the atrunk portion 73, 73'. The trunk portion optionally has one ormore compression slots 74,74'.

FIGS. 12 through 17 show an embodiment of the presentinvention for placement on an anterior aspect ofa left claviclewith the version for the right clavicle being a mirror image.This embodiment of the plate 210 has a profile having a

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central trunk 212 with two sets ofterminal arms 220 similar tothe plates shown in FIGS. 1-5 except that the short armsextend away from the same side of the trunk relative to themedial line. Thus, the plate forms an X with two short arms213 on the same side and two longs arms 214 on the same sideand the elongate central trunk 212 bridging the span betweeneach terminal set of arms. The central trunk includes a slightlongitudinal curve, and the bottom 227 of the plate has a radialcurve as can be seen in the end view of FIG. 14, and in thecross-section shown in FIG. 16.Thus, the plate forms a seg-ment of a torroid. The trunk includes two translation slots230, which are obround and in the middle of the plate andwhich are used for initial fixation and which subsequentlyallow for translation of the plate relative to that fixation. Theplate further includes two screw holes 232 which are shown aslocking holes having internal threads. These holes furtherinclude keyways 233 for the mating portion of a drill guide inorder to set the pilot hole for a locking screw received in theseholes.

The plate 210 has a two pairs of arms 220 that extend aspreviously described. Specifically, for each pair of arms, eachof the first 213 and second arm 214 include a screw hole 235which defines an axis of the screw (perpendicular to a tangentat the diameter of the screw hole) and the arms have a longi-tudinal axis which is a line intersecting the screw axis and thelongitudinal axis of the central trunk. The arms spiral or wraparound in the same direction that the central trunk does. Thescrew holes 235 are preferably threaded locking holes, whichalso include keyways for a drill guide that sets the angle forthe locking screw. For each arm, the longitudinal axis definesan angle relative to the longitudinal axis of the central trunk,and the angle is different for one arm than for the other arm ina terminal pair as is shown for the embodiment shown in FIG.1.The plate demonstrates a mirror symmetry about the trans-verse plane since the two short arms have a correspondingangle, length and shape and the two long arms have a corre-sponding angle, length and shape.

As has been previously described, the pair of arms includean interior curve in the same direction as the radial curve inthe central trunk portion. The difference in the length andangles of the arms allows for multiplanar fixation and con-vergence of the screws (which are locking screws) whileavoiding impingement of the screws with each other. Thus,the plate is designed to fit the lateral ti of the clavicle and thearms are designed wrap around the shaft of the bone. Theplate is shown with a central trunk that includes two obroundslots in the central trunk and two locking screw holes thatinclude internal threads and keyways for a drill guide to setthe angles for the screws. The plate also includes two terminalsets of arms each having a short arm and a long arm with theshort arms on the same side for ease of insertion through theincision. The plate can have one or no slots and from I to 8screw holes. FIG. 17 illustrates the placement of the plate onthe anterior/inferior aspect in the mid-shaft portion of aclavicle.

FIGS. 1S-29 show two slightly different embodiments ofthe plate of the present invention which vary according to thelength of the elongate central trunk and accordingly, to thenumber of screw holes in this section ofthe plate. However, inboth versions, the plate 310, 310' has a y-shaped footprintwhich comprises an elongate central trunk 312, 312' having amedial line and along the medial line, through holes, (whichcan either be slots 316, 316' such as compression slots ortranslation slots) and/or screw holes 317, 317' (which caneither be smooth for variable locking or threaded for lockingholes). In these embodiments, the holes of the central bodyare aligned with their centers along a straight medial line (or

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in this instance a plane), which divides the plates in two lateralhalves. The area between the through holes curves inwardtoward the medial line to allow the plate to be further con-toured without deforming the holes.

One end of the central trunk includes a single pair of arms320, 320' with a longer arm extending at a first angle from themedial line of the plate and having a shorter length than thesecond arm which extends from the plate at a second angleand has a longer length. The arms include a rounded portion324, 324' that defines a portion of a circle and has a linkingarea that has a smaller width than the diameter of the circle.Each rounded portion includes a screw hole 326, 326' mayadvantageously include internal threads 32S, 32S' and key-way grooves 329, 329' for a drill guide. These embodimentsof the plates are provided in a first version having five lockingholes 317, in the central trunk and three obround translationslots 316.The translation slots 316 may include contouringwith in the lateral edges of the slot that are convex to receivethe rear shoulder or rounded portion of the screw in order tocause the screw to seat in the plate perpendicularly to themedial line. The plate is provided in a right and a left versionand the left version is illustrated in the figures. In this version,the plate is curved along the medial line transverse to themedial line as can be seen in FIGS. 20 and 22. The plate alsoincludes a larger contouring which is like the shape of afishtail in that it bows gently from the end with the pair ofarms in a first direction for approximately the first 't~ to %o ofthe length of the plate, and then curves more sharply in theopposite direction along the z axis.

In the longer version of this plate 310', the plate includesfour obround translation slots 316' which are in the centerbetween three locking screw holes 317' at the end with thearm 320' and four locking screw holes 317' at the other end ofthe central trunk. This plate has similar contouring to theshorter version of this plate, with a radius on the bottom anda fishtail curve with a longer, and shallower curve whichdefines a curve that bows in a first direction from the armsthrough the second of the second set of locking holes, and theplate including the last two looking holes defines a curve inthe opposite direction. Both of these plates are designed forplacement on the middle portion of a clavicle and the choicebetween the two versions depends on the placement andnature of the fracture involved.

FIGS. 30 through 41 illustrate plates that are intended foruse on the superior aspect of the clavicle. Again, left versionsare shown, with the right version being mirror images of theleft version. These plates 410, 410' have elongate centraltrunk portions 412, 412' with two opposing pairs of arms 420,420'. Each of the first 413, 413' and second arm 414, 414' ofa pair of arms 420, 420' include a screw hole 435, 435' whichdefines an axis of the screw (perpendicular to a tangent at thediameter of the screw hole) and the arms have a longitudinalaxis which is a line intersecting the screw axis and the longi-tudinal axis of the central trunk as medial as possible to thearm. The arms spiral or wrap around in the same direction thatthe central trunk does. The screw holes 435, 435' are prefer-ably threaded locking holes, which also include keyways fora drill guide that sets the angle for the locking screw. For eacharm, the longitudinal axis defines an angle relative to thelongitudinal axis ofthe central trunk, and the angle is differentfor one arm than for the other arm as is shown for the embodi-ment shown in FIG. 1.The plates demonstrate a mirror sym-metry about the transverse plane since the two short armshave a corresponding angle, length and shape and the twolong arms have a corresponding angle, length and shape.

The central trunk in the two versions shown in FIGS.30-41, (with the shorter version shown in FIGS. 30-35 and the

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longer version shown in FIGS.36-41)varies by the length andaccordingly by the number of through holes in the trunk. Inthe shorter version, there are two translation slots 416 that arealigned along the medial line and are flanked by a first lockingscrew hole 417 and a last locking screw hole 417.This area ofthe plate also includes curves between the screw hole thatallow the plate to be contoured without bending the throughholes. The plate had a shallow longitudinal C curve in thedirection away from the shorter arm side of the plate. Thebottom side 427 of the plate also includes a radius to betteraccommodate the shape of the bone.

The version of the plate shown in FIGS. 36-41 has a longercentral trunk 412' which includes four translation slots 416'aligned along the medial line and flanked by two lockingscrew holes 417'.Again, the central trunk portion of the platecurves gently in the direction of the shorter arms and thebottom 427' of the plate includes a radius. FIG. 35 shows theplacement of the shorter plate on the inferior spine of aclavicle.

FIGS. 43-47 illustrate a plate for use on the lateral aspect ofthe clavicle. This plate 510 has an x-shaped profile, with anelongate central trunk and a first pair of arms 520 whichextend at different angles and for different lengths from thetrunk and further which include a curve on the bottom side sothat the arms spiral around the bone and the screws that areplaced in screw holes 535 in the arms provide for multiplanarfixation and do not impinge on each other. The central trunkincludes two translation slots 516 and two locking screwholes 517 in the proximal end of the plate (ke. adjacent to theend with the pair of arms 520). The other end of the plateincludes a pair of arms 530 that differs from the other pairs inthat there is a necked transition area 531 including screwholes 532 that are aligned with the terminal screw holes 533in these arms. There is again a shorter arm 540 and a longerarm 541, which include threaded locking screw holes andkeyway guide grooves. The plate has a shallow S shape alongthe medial line with the more proximal of the two translationslots marking the transition between the lobes of the S. Theplate includes a bottom radius, FIG. 47 shows the plate inposition on the distal portion of a clavicle.

While in accordance with the patent statutes, the best modeand preferred embodiment have been set forth, the scope ofthe invention is not limited thereto, but rather by the scope ofthe attached claims.

What is claimed is:1.An orthopedic plate comprising:an elongate central trunk portion having a medial longitu-

dinal plane and at least one pair of divergent arms, eacharm including a threaded screw hole, and each arm of thepair of divergent arms diverging asymmetrically awayfrom the medial longitudinal plane relative to the otherarm of the pair ofdivergent arms and wherein the centraltrunk portion has an inferior surface defining a curvetransverse to the medial longitudinal plane and has a

compression slot having an internal edge which includesa shoulder that slopes toward the inferior side of theorthopedic plate as it extends away from the first end ofthe central trunk portion.

2. The orthopedic plate as set forth in claim 1, wherein theorthopedic plate defines an outline including the elongatecentral trunk portion which has a first side edge and a oppos-ing second side edge disposed on opposite sides of the mediallongitudinal plane, and the pair of divergent arms comprise afirst arm which diverges from the first side edge and a secondarm which diverges from the second side edge.

3. The orthopedic plate as set forth in claim 1, wherein theorthopedic plate has a top surface and the medial longitudinal

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plane intersects the top surface of the orthopedic plate in alongitudinal plate axis, each of the pair of divergent armthreaded screw holes has a mid-point, and the pair of diver-

gent arms comprise a first arm which has a longitudinal armaxis that intersects the mid-point of the first arm threadedscrew hole and the longitudinal plate axis to form a first anglewith the longitudinal plate axis and a second arm which has alongitudinal arm axis that intersects the mid-point of thesecond arm threaded screw hole and the longitudinal plateaxis to form a second angle with the longitudinal plate axis,and the first angle is different than the second angle.

4. The orthopedic plate as set forth in claim 3, wherein thefirst longitudinal arm axis and the second longitudinal armaxis respectively have a first length and a second length eachrespectively defined from the intersection of the threadedscrew hole mid-point and the intersection of the longitudinalplate axis and the first length is different from the second

length.5. The orthopedic plate as set forth in claim 1, wherein the

medial longitudinal plane defines a medial axis in the centraltrunk portion and the curve is constant along the medial axis.

6. The orthopedic plate as set forth in claim 5, wherein thecurve is a portion of a circle and the orthopedic plate definesa segment of a cylinder.

7.The orthopedic plate as set forth in claim 1, wherein eacharm of the pair of divergent arms includes a waist.

S. The orthopedic plate as set forth in claim 7, wherein thepair of divergent arms comprise a first arm and a second armeach having a linking section joined to the central trunkportion and the waist of the linking section of the first arm andof the second arm is configured to bend relative to the centraltrunk portion in response to a force applied to at least one ofbefore or during surgery without deforming the threadedscrew holes of the pair of divergent arms.

9. The orthopedic plate as set forth in claim 1, wherein thecentral trunk portion has a through hole.

10.The orthopedic plate as set forth in claim 9, wherein thecentral trunk portion has at least two through holes and acentral trunk portion waist area between the through holeswhich encourages bending of the central trunk portion waistarea in response to a force applied before or during surgery.

11.The orthopedic plate as set forth in claim 1,wherein theorthopedic plate has a superior surface of the central trunkportion which opposes the inferior side of the plate in crosssection, and the superior surface of the central trunk portionincludes a visual indication of the direction in which thecompression slot can be used to apply compression.

12.The orthopedic plate as set forth in claim 1,wherein thethreaded screw holes have a screw axis and further includingscrews having a threaded shaft and a head wherein thethreaded screw holes and the screw heads of each screw havea mating interface such that the screw can engage a threadedscrew hole so as to allow a plurality of angular orientations ofthe screw axis of that threaded screw hole.

13.A plate system for use in bone comprising:a first locking screw and a second locking screw, anda bilaterally asymmetrical plate having an elongate central

trunk with a medial longitudinal axis and at least one setof arms disposed at a terminal end of the plate, whereineach arm of the at least one set of arms diverges asym-metrically away from the medial longitudinal axis rela-tive to the other arm of the pair of arms, each arm of theasymmetrical pair including a threaded locking screwhole, and each of the threaded locking screw holes of theasymmetrical pair having one of the first locking screwand the second locking screw locked to the plate andeach of the first locking screw and the second locking

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14screw have a proximal end and a distal end whichextends from the orthopedic plate, and the distal ends ofthe screws converge toward each other, but do notimpinge and

wherein the elongate central trunk has a compression slothaving an internal edge which includes a shoulder that

slopes toward the inferior side of the orthopedic plate asit extends away from the first end of the elongate centraltrunk.

14. The plate system as set forth in claim 13, wherein oneor both of the first locking screw and the second locking screware variable locking screws.

15. The plate system as set forth in claim 13, wherein theorthopedic plate is bilaterally asymmetrical about the medialline or a transverse axis.

16. The plate system as set forth in claim 13, wherein theorthopedic plate has mirror symmetry about a transverse axis.

17. The plate system as set forth in claim 13, wherein theorthopedic plate has only one set of arms and an outline thatforms a Y-shape or the orthopedic plate has only two sets ofterminal arms which are at either end of the elongate trunkand an outline that forms an X-shape.

1S.The plate system as set forth in claim 13, wherein thecentral trunk portion has an inferior surface defining a curvetransverse to the medial longitudinal plane and the curve is aportion of a circle and the orthopedic plate defines a segmentof a cylinder.

19.The plate system as set forth in claim 13, wherein eacharm includes a linking section joining the arms to the elongatecentral trunk and each linking section has a waist and thewaist of the linking section of the first arm and of the secondarm is configured to bend relative to the elongate central trunkin response to a force applied at least to one of before orduring surgery without deforming the threaded screw hole ofthe first or second arm.

20. A plate system for use in bone defining an axis andcomprising:

a first locking screw,and a second locking screw,and a plate having a trunk, andat least one pair of terminal arms wherein each terminal

arm diverges asymmetrically outward from the trunkrelative to the other terminal arm of the pair of terminalarms and each of the terminal arms having a threadedlocking hole which is in locked communication respec-tively with one of the first and the second locking screw,the plate being contoured in three dimensions so that theterminal arms spiral so as to wrap around the bone axisin a portion of a double helix extending through an arc ofless than 50',

wherein each terminal arm includes a linking section join-ing the terminal arms to the trunk and each linkingsection has a waist and the waist of the linking section ofthe first arm and of the second arm is configured to bendrelative to the trunk in response to a force applied beforeor during surgery without deforming the threaded screwhole of that arm and the trunk has at least two throughholes and a trunk waist area between the through-holeswhich encourages bending of the trunk waist area inresponse to a force applied before or during surgery andthe plate has an inferior side and a compression slot.

21.The plate system as set forth in claim 20, wherein eachof the first locking screw and the second locking screw havea proximal end and a distal end which extends from the plate,and the distal ends of the screws converge toward each otheron the inferior side of the plate, but do not impinge.

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22. The plate system as set forth in claim 20, wherein oneor both ofthe first locking screw and the second locking screware variable locking screws.

23. The plate system as set forth in claim 20, wherein theplate defines a medial line and the plate is bilaterally asym-metrical about the medial line or the transverse axis.

24. The plate system as set forth in claim 20, wherein theplate defines a transverse axis and the plate has mirror sym-metry about the transverse axis.

25. The plate system as set forth in claim 20, wherein theplate has only one set of arms and an outline that forms aY-shape or the plate has only two sets of terminal arms whichare at either end of the trunk and an outline that forms anX-shape.

26. The plate system as set forth in claim 20, wherein thetrunk defines a medial line and the trunk has an inferiorsurface defining a curve transverse to the medial line.

27. The plate system as set forth in claim 20, wherein thecurve is constant along the medial line.

2S. The plate system as set forth in claim 27, wherein thecurve is a portion ofa circle and the plate defines a segment ofa cylinder.

29. The plate system as set forth in claim 20, wherein theplate has a superior surface of the trunk which opposes theinferior side of the plate in cross section and the superiorsurface of the trunk includes a visual indicator ofthe directionin which the compression slot can be used to apply compres-sion.

30. The orthopedic as set forth in claim 20, wherein theplate has an outline consisting of the trunk, which is anelongate central trunk portion terminally branching at eitherone or two ends in the pair of terminal arms which are exactlytwo divergent arms, each arm having a rounded end linked tothe central trunk through a waisted section having a lengthwhere one waisted section has a greater length for one arm ofa pair than the second waisted section of a pair.

31.The orthopedic plate as set forth in claim 30, whereinthe plate further includes a first locking screw engaged in alocking screw hole ofa first arm of a pair of terminal arms anda second locking screw engaged in a locking screw hole of asecond arm of a pair ofterminal arms and wherein each ofthefirst locking screw and the second locking screw have a proxi-mal end and a distal end which extends from the plate, and thedistal ends of the screws converge toward each other on theinferior side of the plate, but do not impinge.

32. The orthopedic plate as set forth in claim 30, whereineach of the first locking screw and the second locking screwhave a proximal end and a distal end which extends from theplate, and the distal ends of the screws converge toward eachother, but do not impinge.

33. The orthopedic plate as set forth in claim 30, whereinone or both of the first locking screw and the second lockingscrew are variable locking screws.

34. The orthopedic plate as set forth in claim 30, whereinthe plate defines a medial line and the plate is bilaterallyasymmetrical about the medial line or the transverse axis.

35. The orthopedic plate as set forth in claim 30, whereinthe plate defines a transverse axis and the plate has mirrorsymmetry about the transverse axis.

36. The plate system as set forth in claim 20, wherein thecompression slot has an internal edge which includes a shoul-der that slopes toward the inferior side of the orthopedic plateas it extends away from the first end of the elongate centraltrunk.

37.An orthopedic plate comprising:an elongate central trunk portion having a medial longitu-

dinal plane and at least one pair of divergent arms, each

Ex. 1004 P28 v. WMT

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Page 20: United States Patent No. 9, B2 Kay Date B.knobbemedical.com/wp-content/uploads/2019/04/US-Patent-No.-1.pdfUS 9,259,253 B2 1 ORTHOPEDIC PLATE FOR USE IN SMALL BONE REPAIR CROSS-REFERENCE

15US 9,259,253 B2

16arm including a threaded screw hole, and each arm of thepair of divergent arms diverging asymmetrically awayfrom the medial longitudinal plane relative to the otherarm of the pair of divergent arms and wherein the ortho-

pedic plate has an inferior side and the central trunk

portion has a compression slot and comprising a slothaving an internal edge which includes a shoulder thatslopes toward the inferior side of the orthopedic plate asit extends away from the first end of the central trunk

portion and the orthopedic plate has a superior surface ofthe central trunk portion which opposes the inferior sideof the plate in cross section, and the superior surface ofthe central trunk portion includes a visual indication ofthe direction in which the compression slot can be usedto apply compression.

3S.An orthopedic plate system comprising:a first locking screw and a second locking screw, anda bilaterally asymmetrical plate having an elongate central

trunk portion having a medial longitudinal plane and atleast one pair of divergent arms, each arm including athreaded screw hole, and each arm of the pair of diver-

gent arms diverging asymmetrically away from themedial longitudinal plane relative to the other arm of thepair of divergent arms and wherein each of the firstlocking screw and the second locking screw have aproximal end and a distal end which extends from theorthopedic plate, and the distal ends of the screws con-verge toward each other, but do not impinge and whereinthe orthopedic plate has mirror symmetry about a trans-verse axis.

39. The orthopedic plate system as set forth in claim 3S,wherein one or both of the first locking screw and the secondlocking screw are variable locking screws.

40. The orthopedic plate system as set forth in claim 3S,wherein the plate defines a medial line and the plate is bilat-erally asymmetrical about the medial line or the transverseaxis.

41. The orthopedic plate system as set forth in claim 3S,wherein the plate defines a transverse axis and the plate hasmirror symmetry about the transverse axis.

42. The orthopedic plate system as set forth in claim 3S,wherein the plate has only one set of arms and an outline thatforms aY-shape or the plate has only two sets ofterminal armswhich are at either end of the trunk and an outline that formsan X-shape.

43. The orthopedic plate system as set forth in claim 3S,wherein the trunk defines a medial line and the trunk has aninferior surface defining a curve transverse to the medial line.

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44. The orthopedic plate system as set forth in claim 3S,wherein the curve is constant along the medial line.

45. The orthopedic plate system as set forth in claim 44,wherein the curve is a portion of a circle and the plate definesa segment of a cylinder.

46.An orthopedic plate system for use in bone defining anaxis and comprising:

a first locking screw,and a second locking screw,and a plate having a trunk, andat least one pair of terminal arms wherein each terminal

arm diverges asymmetrically outward from the trunkrelative to the other terminal arm of the pair of terminalarms and each of the terminal arms having a threadedlocking hole which is in locked communication respec-tively with one of the first and the second locking screw,the plate being contoured in three dimensions so that theterminal arms spiral so as to wrap around the bone axisin a portion of a double helix extending through an arc ofless than 50', and wherein the plate has an inferior sideand each of the first locking screw and the second lock-ing screw have a proximal end and a distal end whichextends from the plate, and the distal ends of the screwsconverge toward each other on the inferior side of theplate, but do not impinge.

47. The orthopedic plate system as set forth in claim 46,wherein one or both of the first locking screw and the secondlocking screw are variable locking screws.

4S. The orthopedic plate system as set forth in claim 46,wherein the plate defines a medial line and the plate is bilat-erally asymmetrical about the medial line or the transverseaxis.

49. The orthopedic plate system as set forth in claim 46,wherein the plate defines a transverse axis and the plate hasmirror symmetry about the transverse axis.

50. The orthopedic plate system as set forth in claim 46,wherein the plate has only one set of arms and an outline thatforms aY-shape or the plate has only two sets of terminal armswhich are at either end of the trunk and an outline that formsan X-shape.

51. The orthopedic plate system as set forth in claim 46,wherein the trunk defines a medial line and the trunk has aninferior surface defining a curve transverse to the medial line.

52. The orthopedic plate system as set forth in claim 46,wherein the curve is constant along the medial line.

53. The plate system as set forth in claim 52, wherein thecurve is a portion ofa circle and the plate defines a segment ofa cylinder.

Ex. 1004 P28 v. WMT

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