CA2257398C - Apparatus and method for reconstructing ligaments - Google Patents

Apparatus and method for reconstructing ligaments Download PDF

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Publication number
CA2257398C
CA2257398C CA002257398A CA2257398A CA2257398C CA 2257398 C CA2257398 C CA 2257398C CA 002257398 A CA002257398 A CA 002257398A CA 2257398 A CA2257398 A CA 2257398A CA 2257398 C CA2257398 C CA 2257398C
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Canada
Prior art keywords
guidewire
cutting head
bone
assembly
router
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Expired - Fee Related
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CA002257398A
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French (fr)
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CA2257398A1 (en
Inventor
Joseph H. Sklar
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Individual
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17Guides or aligning means for drills, mills, pins or wires
    • A61B17/1714Guides or aligning means for drills, mills, pins or wires for applying tendons or ligaments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1604Chisels; Rongeurs; Punches; Stamps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1662Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
    • A61B17/1675Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the knee
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A61B17/1764Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the knee
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • A61B17/3207Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320758Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00867Material properties shape memory effect

Abstract

This invention is an apparatus for removing bone from a femoral notch, which includes a guidewire (50) and a router assembly (55). The router assembly comprises a cutting head (67) fixed to a shaft (70) rotatably disposed in a hole through a body portion (80) of a shield assembly (75). A hood portion (85) of the shield assembly extends from the body portion of the shield assembly, and covers a first portion of the cutting head while leaving exposed a second portion of the cutting head. The guidewire extends through a hole (95) in the shaft, cutting head, and shield assembly hood portion such that the router assembly (55) is movable along the guidewire. The shaft (70) is rotatable in the shield assembly body portion, such that the second portion of the cutting head is engageable with the bone and operative to remove portions of the bone.

Description

I\PPIUt7\'I'US AND Mf:'1'1101) I"OR (?I;CONS'L'I2UC'1'ING LIGIIMCNI'S

Field Of The InvenLion This invention relates Lo medical apparatus and methods in general, and inore particularly to apparatus and methods for reconstructing ligaincnLs.

Background Of The Invenl'ion Ligaments are tougii bands of Lissue wliich serve Lo connect the articular extr.einiLies of boiles, or to support or retain organs in place wiLhin Llie body. Ligaments are typically composed of coarse bundles of clense whiLe fibrous tissue which are disposed in a parallel or closely interlaced manner, with Lhe fibrous tissue being pliant and flexible, but not extensi.ble.

In many cases, ligamenLs are Lorn or ruptured as a result of accidents. ns a result, var.ious procedures have been developed to repair or replace sucli dainaged ligaineriLs. -For example, in Lhe human knee, Lhe anterior and posLerior cr.uciaLe ligamenLs (i.e., Lhe nCL and PCL) extend between Llie top end of the tibia anci the boLLoin end of Lhe fcmur. The ACI, and PCL cooperate, together with other ligaments and soft tissue, to provide both static and dynamic sCabiliLy to Lhe knee. Ofteii, the anterior cruciate ligament (i.e., Llie 71CL) is ruptured or torn as a result of, for example, a sports-related injury.
Consequently, various surgical procedures have been developed for SUBSTITUTE SHEET (RULE 26) reconstructing Llie ACL so as Lo restore normal function to the knee.

In many instances, Llie ACL may be reconstructed by replacing the ruptured ACL wiLh a synLheLic or harvesLed graft ligament.
More particularly, with such procedures, bone tunnels are typically formed in the top end of the Libia and the bottom end of the femur, with one end of Llie grafL ligament being positioned in the femoral tunnel and L'tie oLher end of Lhe graft ligament being positioned in the tibial L-tinnel. The Lwo ends of ttie graft ligainent are aiictiored in place in various ways well known in the art so that the grafL .1.igamenL exl'ends between the femur and the tibia in subsLantia.l.ly Lhe same way, and with substantially the same function, as the original 11CL. This graft ligament then cooperates with the surrounding anaLomicaJ. structures so as to restore normal function Lo the knee.

IL will, of course, be appreciatecl Lliat a complex interdependency exists between Lhe ACL and the other elements of the knee, e.g., L-he bones, the other I;nee ligaments, and aLl-ier soft tissue. Consequently, it is critical Lhat the graft ACL be disposed in exactly the rigltt posiLion relative to the other anaLomical structures of Lhe knee if norinal knee function i.s Lo be restored. Corresponciingly, it has been found that the aforementioned bone tunnels must be Prccisely positioned in the tibia and femur if successful reconsL-r.uction of the ACL is to be achieved. Unfort'unate.ly, proper positioning of these bone SUBSTITUTE SHEET (RULE 26) L-unnels to satisfy isomeLr.ic considerations can sometiines lead to anatomical conflicts within Llie knee when the graft ACL is installed within the knee.

More particularly, the ACL normally extends between the bottoin end of Lhe ferntir and Lhc top end of Lhe Libia, with the body of the ACL passing Lhrougli the femur's intercondylar notch and across the interior of the knee joint. See, for example, Figs. 1 and 2, which show a natural ACL 5 extending between the bottom end of a femur 10 and the Lop end of a tibia 15, with the body of ACL 5 passing Lhrotigl- the femur's intercondylar notch 20.
Also shown is a natural PCL 25 exLending between the bottom end of femur 10 and the top end of Libia 15.

It is to be apprecial'ed Lliat Lhe position of the various knee elements move relative to one another as the knee is flexed through a range of natural inoLions. See, for example, Fi.g. 3, which shows ACL 5 nioving across a110 arc as the knee joint is flexed through a 140 moLion.

Due to the complex geotneLries of Lhe knee, where a damaged ACL is to b.e replaced by a graft ACL, it is critical that the graft ACL be connecLed at preci.sely the right locations on the bottom end of the femur and top end oC the Libia. Thus, and looking now a L Figs.I and 5, where a clatnaged ACL is to be replaced by a graft ACL, ttie damaged ACL is first cleared away and ttien bone tunnels 30 and 35 are formed in the tibia and femur, respectively. The precise locations of these bone tunnels SUBSTITUTE SHEET (RULE 26) 30 and 35 are dictaLed by Lhe isometric relationsiiips of Lhe knee. In pracLice, bone Lunnels 30 and 35 are formed using a surgical drill guide which is keyed to certain parls of the pa tienL' s ana Lomy, e. g. , Lo the patierit' s Libial plateau. Once bone tunnels 30 and 35 liave been formed, Ltie graft ACL may be installed in ways well known in the art. See, for example, Figs.
6 and 7, which show a graf t ACL 511 having one end mounted to femur 10 and the ol:her end mounted Lo tibia 15.

Unfortunately, in some s.iLuaLions, proper isometric placemenL of bone L'unnels 30 and 35 may cause anatomical conflicts within t'he knee wlien Llie graft ACL is installed in the patient. Dy way of example, iind of particular interest in connection with the present invention, proper isometric placement of bone tunnels 30 and 35 may result in portions of the femur impinging upon the graft RCL as the knee is inoved through its full range of natural motions. See, for example, Fig. 8, which shows one of the femur's condyles 40 impinging upon a graft ACL
5A extending througll the femur's intercondylar notch 20; and Fig.
9, wliich shows ttie roof l:he femur's intercondylar notch impinging on the graft ACL 5A in the vicinity of arrow 42.

Impingement can occur for a varieLy of reasons. For one thing, the intercondylar notch of many patients (particularly those who are susceptible to rupture of Llie nCL) is frequently small to begin with. For another thing, the graft ACL (i.e., the SUBSTITUTE SHEET (RULE 26) synthel.ic or harvesLed gra[L .ligainenL which is bein(j installed in place of the damaged nalura.t ACL) is generally fairly large.
nddiLionally, slight mispositioning of bone Lunnels 30 and 35 can also lead to iinpingeinenL problems.

Unfortunately, impingement of the feinur on the grafL
ligament can reduce the effecLiveness of the nCL reconsLruction procedure or even cause i.L Lo fai.l altogether.

Thus, when perforining an ACL reconsLruclion procedure, the surgeon generally tries to ensur.e LIiaL Llier.e is sufficient room within Llie paL'ienL's inLercondy.lar notch to receive the graft ligament. This j.s generally done by perforining notchplasty, i.e., by surgically reinoving any impinging bone from the sides and/or roof of Lhe inLercondyl.ar notch. nL Lhe same time, of course, it is also important that the surgeon remove no inore bone than is absolutely necessary, so as to ininimize trauma to the patient.

Unfortunately, it is difficulL for. Ltie surgeon to accurately gauge Lhe precise amounL of bone L'haL must be removed from Lhe notch in order to avoid impingement. For one thing, the ACL
reconstruction procedure i.s typically performed arthroscopically, so that the surgeon's view of the surgical site is frequently fairly restricted. For anol-her thing, Lhe surgeon typically will not l:now=.Lhe precise space lhat ttie grafl ACL will occupy until.
the graft is actually in place; but at that point in the procedure, it is frequently difficult to inser.t additional bone-SUBSTITUTE SHEET (RULE 26) cutting instruments into the joint so as to remove more bone, parLicularly wiLhout cutting tiie graft ACL. I'urthermore, experience has shown LhaL Ltie most ser.i.ous problems with impingement occur superiorly; but even with the graft ligamenL- in place, Lhe surgeon is generally unable Lo see impingement at this location due to limitations in arthroscopic visualization. Also, the surgeon typically perforens Lhe ACL reconstruction procedure in a relatively static context, i.e., wiLh Lhe knee being relatively stationary at any given momenL during the reconstruction procedure. ilowever, Lhe knee niust perform (and impingement musL be avoided) in a relaLively dynamic context, i.e., as the knee is moved throughout a full range of natural motions. This comp].icaLes the surgeon's task of eliminating impingement.

Objects Of The Invention Accordingly, one.objecL of the presenL invention isto provide improved apparatus for.r.econsLructing a ligament.
Another object of the present invention is to provide improved apparatus for reconstructing an anterior cruciate ligament (11CL).

And another object of the present invention is to provide improved=apparal-us for quickly, easily and reliably eliminating impingement problerns when reconstructing an anterior cruciate ligament.

SUBSTITUTE SHEET (RULE 26) ..___ ...._ __._._...~....~.-~.-.__ __ _ Still another object of Lhe pr.esent invention is to provide improved apparatus for quickly, easily and reliably removing any anatomical structures (e.g., bone) which will conflict wil-h the location of a graft ACL at Chc completion of an ACL
reconstruction procedure.

Yet another object of the present invention is to provide improved apparatus for quickly, easily and reliably removing any anatomical structures (e.g., bone) which will conflict with L-he location of a graft ACL as the knee is moved through a full range of natural moL'ions.

And an object of the preserit irrvenLion is to provide an improved method for reconstrucLing a ligament.

1lnother object of the presenl invention is to provide an improved meL-hod for reconsL-rtrcting an anterior cruciate ligament (ACL).

And another objecL of the presenL- irivenlion is L'o provide an improved method for quickly, easily and reliably eliminating impingement problems wlien reconstructing an anterior cruciate ligament.

SLill another object of the present invention is to provide an improved method for quickly, easily and reliably removing any anatomical structures (e.g., bone) whicli will conflict with the location of a graft ACL at the coinplelion of an ACL

reconstruction procedure.

SUBSTITUTE SHEET (RULE 26) t3 Yet another objecL of Lhe present invenLion is to provide an improved method for quickly, easily and reliably reinoving any anatomical strucLures (e.g., bone) whi.ch will conflict with the location of a graft nCL as Lhe knee is inoved Lhrough a full range of natural motions.

Sununary Of The Invention These and ol'her objecLs are addressed by the present invention, which comprises the provision and use of novel apparatus for reinov.ing impinging bone during a ligament reconsLruction procedure.

In one preferred form of L'tie invenL.i.on, Lhe novel apparatus comprises a guidewire and a router assembly.

The guidewire i.s similar t:o other guidewires of the sort well known in the art, excepL that iL is preferably formed out of a pseudoelastic material, i.e., a "shape memory alloy (SMA)/stress induced marL'ensite (SIM)" inaterial such as Nitinol.

The router asseinbly compri.ses' a cannulated router device and a shield assembly. The cannulal-ecl router device comprises a cannulated cutting head whicli is atl:ached to a cannulated shaf't.
The shield assembly coniprises a body and a hood. The body includes a hole therein. 'I'he hood extends about one end of the body. The router assembly is asseinblcd so that the router device has its cutting head disposed at one end of the shield assembly's body and the router device has its sliaft extending through the SUBSTITUTE SHEET (RULE 26) hole in the shield asseuibl.y' s body. The shield assembly's hood covers a first portion of the rouLer clev.i.ce's cutting liead while leaving a second porL.ion of the cuLLing liead exposed.

The guidewire is deployed in the body so that it extends along the length wher.e Llie graft ACL will reside. The router assembly is mounLed on the guidewire by passing the guidewire through the router device's shafL and cutting head, such that the router assembly is movabie along the guidew.ire. The router device's shaft is rotatable in the shield assembly such that the cutting head can be turned so as to remove bone wliile the router assembly is riding on the guidewire. Portions of the router assembly engaging the guidewi.re are formed so as to be flexible.
On account of the fact that boL'li the giiidewire and portions of the router assembly are formed so as Lo be flexible, the router assembly can be used to remove .impingiiig bone as the knee is flexed through a full range of natural mol:ions.

In accordance wil:h another form of the invention, there is providecl alternative apparaLus for removing iinpinging bone, Lhe alternative apparatus comprising a guidewir.e and a cannulated router device. Again, Lhe guidewire is preferably formed out of a pseudoelastic inaLeria.l. The cannulated router device comprises a cannulated cutting head which is attached to a cannulated shaft. In this embodiment of Lhe invention, Lhe cutting head is devoid of cutting means on a first portion of the periphery thereof and is provided with cutting means on a second portion of SUBSTITUTE SHEET (RULE 26) the periphery Lher.eof. 'l'he second portion of Lhe cutting head i.s engageable with Llie impinging bone porLions which are L'o be removed.

Again, Lhe guiclewire is deployed in the body so that it extends along Lhe length wlier.e Llie graft ACL will reside. The router device is mounted on the guidewire by passing the guidewire through. the r.outer dev.i.cc' s sha f L' and cutLing liead, such that the router device is movable on the guidewire. The router device is rotatably inovable in an oscillating f.astiion such that Lhe cutting head' s seconci portion inoves in alternating opposite directions across Lhe impinging bone to remove portions thereof. The firsL portion of the cuLLing head is smooth and non-destructive with respecl. to any anatoinical structures which the first portion may coine into contact with. Portions of the router device engaging the guidewire are formed so as to be flexible. On account of the facL that both the guidewire and portions of the router device are formed so as to be flexib.le, the router device can be used to remove impinging bone as the knee is flexed through a full range of natural motions.

In accordance with another forin of Lhe invention, there is provided alternative apparatus for removing impinging bone, the alternative apparatus comprising a guidewire and a cannulated router device. Again, the guidewire is preferably formed out of a pseudoelastic material. The cannulated router device comprises a cannulated cutting head wliich is attached to a cannulated SUBSTITUTE SHEET (RULE 26) shaft. In this embodiment of Lhe invention, the cutting head is adapted to cut bone wliicli conies inLo contact with the cutting liead, but to leave uiiharmed soft Lissue which comes into contact with the cutting liead.

Again, the guidewire is deployed in Llie body so that it extends along the lengLh where Llie ACL graft will reside. The router device is mouiiLed on Llie guidewire by passing the guidewire through the router device's s11af't and cutting head, such that the router devi.ce is movable on Lhe guidewire. The router device is rotatably movable on L-lie guidewire so as to cut away impinging bone. Again, portions of the router device engaging the guidewire are formed so as to be flexible. On account of the fact Lhat both Llie guidewire and portions of the router device are formed so as to be flexible, the router device can be used to remove impinging bone as the knee is flexed through a full range of natural motions.

In accordance wil'li another form of the invention, there is provided apparatus for marking por,tions of impinging bone which are Lo be thereafter removed, the apparatus comprising a guidewire and a cannulated inar.king devicc. Again, the guidewire is preferably formed out of a pseudoelastic inaterial. The cannulated marking device comprises a cannulated marker head attached to a cannulated shafL.

Again, the guidewire is deployed in the body so that it extends along the length where the graft ACL will reside. The SUBSTITUTE SHEET (RULE 26) inarkirig device is mounLed on Lhe guidewire by passing the guidewire Lhrough the marking device's shafL and marking head, such that the marking head is movable on Lhe guidewire. The marking head is adapted Lo hold a dye and to release that dye upon contacL with bone, whereby Lo mark the .iinpinging portions of the bone proxirnaLe to Llie guidewire as the inarking head moves on the guidewire. Porti.ons of the marking device engaging the guidewire are formed so as to be flexible. On account of the fact that both L-he guidewire and portions of the marking device are formed so as Lo be flexible, Lhe marking device can be used to inark impinging bone as the knee is flexed through a full range of natural motions.

In accordance with a further feature of the inventiori, there is provided a meLhod for removing iinpinging portions of bone, the method comprising the steps of providing a flexible guidewire and a flexible cannulated router cievice. The guidewire is anchored in the bone so t'hal iL extends along the length where the graft ACL will reside; and Llie cannulated router device is rotatably mounted on the guidewire so that .'tL is movable on the guidewire.
Then the cannulated rouLer device is rotated on the guidewire as the knee is flexed Llirougli a range of naLural motions so as to dynamically remove iinping.ing bone.

SUBSTITUTE SHEET (RULE 26) Brief Description Of 7'he Drawiiss These and oLher objects and fcaLures of Lhe present invention will be mor.e fu.l..ly disclosed or rendered obvious by the following detailed description of Lhe preferred embodiments of the invention, which are to be considered LogeL'lier with the accompanying drawings wherein l.ike number.s refer to like parts and further wtierein:

Fig. 1 is a scheinatic fronL view of a normal knee, where the leg is substantially straight;

Fig. 2 is a schematic side view, partially in section, of the knee shown i.n Fig. l. ;

Fig. 3 is a schematic side vi.ew, showing tiow the nCL moves about within Lhe knee joinL as Ll-e knee is flexed through a range of natural motions;

Fig. 4 is a scheiaaL.ic fr.onL view of a knee, where the knee is bent at approximately a 90 angle, and where a damaged ACL has been removed and bone Lunnels have been forined in the tibia and the femur;

Fig. 5 is a schematic side view of tlie knee shown in Fig. 4;
Fig. 6 is a schemaLic front view of a knee, where the knee is bent at approxiinaLe.ly a 90 angle, showing a grafL= ACL
installed in Llie knee;

rig.- 7 is a schemaLic side view of Lhe knee shown is Fig. 6;
Fig. .is a schemaLic front view showing how portions of the femur can impinge upon a graft ACL;

SUBSTITUTE SHEET (RULE 26) ['ig. 9 is a schematic side view showing how portions of the femur can impinge upon a gra[L ACL;

Fig. 10 is a scliemaLic side view of the guidewire used in connection wiL'h the presenL invention;

Fig. 11 is a schcinaLic pcr.specL.ive view showing one form of router assembly for.meci in accordance with Llic present invention;
Fig. 12 is a scl7eltlat.lC: pcrspecLi.ve view of the router assembly's cannulaLed r.ouLer device;

['ig. 13 is a sclietnaLic side view, in section, of the cannulated router device sliown in Fig. 12;

Fig. 14 is a scheniaLic side =i.iew, in secCion, of a portion of the router assembly' s shield assembly;

Fig. 15 is a scliemaLic perspective view of the shield assembl.y' s collar;

Fig. 16 is a sclieinaL.ic side view, in section, of the router assembly shown in f'ig. 11;

Fig. 17 is a schemaLic side view of a knee, where the =knee is benL at approxiinaLely a 90 angle, and where a damaged ACL lias been removed and a bone Lunne.l. has been formed in the tibia, and sliowing a guidewire extendin(j Lhrough Lhe Libia]. bone tunnel and into the femur;

Fig. 18 is a scheinaLic side view of Lhe knee shown .in Fig. 17;

Fig. 19 is a scheinaL-ic front view like ltiat of Fig. 17, excepL showing a router assembly removing lateral bone structures SUBSTITUTE SHEET (RULE 26) from the feinoral noi:cli so as to prevent Lhose lateral. bone structures from impinging on a graft ACL;

Fig. 20 is a schematic side view showing a router assembly removing lateral bone structures froin the femoral notch so as to prevent those lateral bone structures from impinging on a graft AC L ;

Fig. 21 is a schemaL.i.c front view, showing the leg substantially straighC and the router assemb.ly removing roof bone structures from the femoral notch so as to prevent those roof bone structures froin impinging on a graft nCL;

Fig. 22 is a sciiemaL.ic side view of the l:nee and router assembly shown i.n Fig. 21;

Fig. 23 is a scliemaL'ic side view, stiowing the knee flexed at approximately a 140 angle and the router assembly removing bone structures from the fe-noral notch so as to prevent those bone structures from impinging on a graft 11CL;

Fig. 24 is a scheinatic perspective view showing an alternative form of r.outer assembly formed in accordance with the present inv,enLion;

Fig. 25 is a schematic perspective view showing the collar used in connectiori wiLli the router assenibly shown in Fig. 24;
Fig. 26 is a scheinaLic side view, in section, of. the router assembly'shown in Fig. 24;

SUBSTITUTE SHEET (RULE 26) Fig. 27 is a scheinaLic perspective view of anoLher form of router device wliich can be used in connection with the present invention;

Fig. 20 is a sclielnaL.i.c perspective view of yet anoLher forin of router device whicli can used in connection with the present inveiltion;

Fig. 29 is a schemaLic side view of a cannulated marking device formed in accordance with Llie present invention; and Fig. 30 is a schematic side view of a novel type of guidewire asse-nbly fornied in accordance with the present invention.

Detailed Description Of '1'lie Pr.eferrecl Embodiment's Looking first at Figs. 10-16, the present invention provides apparatus and a metliod for removing bone structures from the femoral notch so as to preveriL those bone structures from impinging upon a grafL ACL installed as part of an ACL
reconstruction procedure. The apparatus and method of the present invention are intended to be utilized in an ACL
reconstruction procedure after the dainaged l1CL has been removed from the knee and after bone Lurinel 30 lias been formed in tibia 15, but before bone tunnel 35 lias been formed in femur 10 and the graft 71CL has been positioned in the joint.

Still looking now at Figs. 10-16, in one preferred embodiment of the present invention, the apparatus of the present SUBSTITUTE SHEET (RULE 26) invention comprises a guidew.ire 50 (Figs. 10 and 11) and a router assembly 55 (Figs. .11-16).

Guidewire 50 is generally of the sort well known in Lhe art for guiding cannulated elemenLs Lo a LargeL structure. As such, guidewire 50 includes a sharp po.inL 60 (1.-.i.g. 10) on its distal end, whereby the guidewire can be cir.illed or tapped into a target structure (e.g., f-emur. 10, as will hereinafter be described in furLlier detail). Iiowever, unlike oLher guidewires of the sort known in the art, and in accordance with one preferred einbodiment of Ltie presenL invenL'ion, guiclewir.e 50 is preferably formed out of a liighly elasLic yeL firm inaLeria.l. Preferably, guidewire 50 is formed out of a so-called pseudoelastic material, i.e., a "shape memory alloy (SM11)/sLress induced martensite (SIM)"
material such as Nitinol. l3y forining guidewi.re 50 out of such a high.ly elastic yeL firm material, the guidewire has the rigidity needed to penetrate into bone, yet lias the high elasticity needed to undergo subsLanLial elastic deformation during joint flexure, as will hereinafter be described in further detail.

Still looking now aL ligs. 11-16, router assembly 55 comprises a cannulated router device 65 (Figs. 11-13 and 16) which comprises a cannulated cutting head 67 attached to a cannulated shaft 70. At least the distal portion 70' (Figs. 12, 13 and 16) of cannulated shaft 70 is flexible; the proximal portion 70" of cannulated shaft 70 inay or may not be flexible, as desired. On account of i:his construction, cannulated router SUBSTITUTE SHEET (RULE 26) device 65 can ride on guidewi.rc 50 as rotary cutting motion is imparLed to cuLLing hcad 67 by means of shafL 70. In particular, by forming aL leasL the d.isLal porLion 70' of cannulated shaft 70 so as to be flexible, roul:er device 65 can ride on guidewire 50 and rotate even as guidewire 50 is subjected to substantial bending during knee joinL flexure, as will hereinafter be discussed in furtlier detail.

Router assembly 55 also conipr.ises a shield assembly 75 (Figs. 11 and ].4-16) . Sliielcl asseinbly 75 coinpr.ises a body assembly 80 and a liood Q5.

Body assembly 00 comprises a liollow outer tube 02 (Figs. 14 and 16) and an inner collar 03 (L='igs. 15 and 16). At least the distal portion 02' (T.--igs. 14 and 1G) of hollow outer tube 82 is flexible; the proxiinal portion 02" of hollow outer tube 82 may or may not be flexible, as desired. Collar 83 is sized and positioned so as to terminate aL the juncture of the hollow tube's distal porti.on 82' ancl its proximal portion 82" (Cig; 16).
Collar 83 includes a hole 90 (['igs. 15 and 16) for receiving shaf.t 70 of router device 65. llole 90 is preferably centered within body 80, whereby Lhe rouLer device's cutting head 67 will be centered within shield asseinbly 75.

ilood 85 is attached to body 80 and includes a hole 95 (Figs.
14 and 16) for receiving guidewire 50. llood 85 surrounds a portion of the route.r device's cutting liead 67 but leaves anot-her portion of the cutting head (i.e., the portion extending outboard SUBSTITUTE SHEET (RULE 26) of hood 85) exposed for routing operations. By way of example but not liinitation, liood 05 in.igliL cover approximately 2/3 of Llie circumferential reg.ion surrounding cutting liead 67 and leave approximately 1/3 of the circtimferenLial region surrounding cutting head 67 exposed for cuLLing purposes. Shield 85 may be formed flexible or rigid, as desired.

As a result of this consLr.ucti.on, router assembly 55 can ride on guidewire 50 as a uniL, with shafL 70 rotating cutting head 67 so as to cut away any inaterial (e.g., impinging bone) exposed to Lhe cutting head, cven is hood 05 shields a substantial portion of the cutting hcad from inadvertently cutting other material (e.g., the paL-icnL's PCL). Significantly, due to the flexible nature of shaft portion 70' and tube portion 82', router assembly 55 is able to ride on guidewire 50 even as guidewire 50 is subjected Lo substantial deformation during knee joint flexure.

Looking next at Figs. 17-23, guidew.i.re 50 and router assembly 55 are inLendecl Lo bc used as follows.

First, feinur 10 and tibia 15 are set at approximately a 90 angle and tibial bone L'unne]. 30 is formecl in tibia 15. Then guidewire 50 is passed through tibial bone tunnel 30 and into femur 10 until the sharp distal end 60 of the guidewire is embedded in the feinur, e.g., by dri].ling or. tapping in ways well knowri in the art (see Figs. 17 and 18). If desired, a cannulated guide of the sort well known in the art (not shown) may be SUBSTITUTE SHEET (RULE 26) disposed about guidewire 50 to lie.lp stabilize it as it is embedded into femur. 10. r,11idewi.7e 50 is posiLioned in the patient so that it will extend along the lengLh where the graft ACL will reside.

Next, router asseinbly 55 is loaded onto the proximal end of guidewire 50 and moved down into Lhe interior of the knee joinL
so that the router assembly's c:ul:Ling hcad G7 is in the vicinity of femoral notch 20 (see Figs. 19 and 20) . Then body 80 of router assetnbly 55 is Lurned so that Ltic r.outer assembly's cutting head 67 is directecl Lowar.d Llie iinp.inging portions of the femur which are Lo be reinoved, and so that the rouLer assembly's protective hood 05 is placcd between Llie cutt.ing head and the PCL
so as to protect the PCL from the cutting head. Then shaft 70 is rotated, e.g., witll a power driver (not shown) of the sort well known in the art, so as to rotate cutting liead 67 and thereby cut away any anatomical sLrucl:ures it coines into contact with.

By turning body 80 circumferenLially as required, cutLing head 67 can be used to enlarge femoral noLch 20 while keeping the cutting head from engaging (anc1 Lhereby cutting) the PCL and/or ot'lier sensitive anatomical. struclur.es. [n particular, by turning router assembly 55 so that ii_ faces in the manner shown in Figs.
19 and 20, lal'era7. notcl-i struclures can be removed. Similarly, by L'urning r.outer assembly 55 so that it faces in the manner shown in Figs. 21 and 22, rooC notch sLrucLures can be removed.

SUBSTITUTE SHEET (RULE 26) Significantly, Llie impinging bone can be removed quickly, easily and safely, without direct visualization of the anatomical structures being trimmed away, due Lo Lhe use of guidewire 50 and the guidewire-following r.oul:er assembly 55.

In particular, it is to be appreciated LIiaL', by posiLioning guidewire 50 so LhaL .iL will exLend along Llie length where the graft 11CL will reside, and by properly sizing the radial dimensions of router assernbly 55 relative to Llie graft ACL which will thereafter be installed, Lhe router assembly will clear away only as much bone as is requirecl Lo properly size the feinoral notch and eliminate impingement problenis. ['urLlierntiore, by properly sizing Lhe longitudinal dimensions of router assenibly 55 relative to the nolcli regiori wiiere impingement occurs, impingemenL can be elimi.naLed by jusL circumferential movement of router assembly 55 on guidewire 50, i.e., without requiring longitudinal movement of router assembly 55 on guidewire 50 during bone-trimming operations.

Significantly, since guidewire 50 is preferably formed out of a highly elasLic maL'erial, and since the router assembly's shaft portion 70' and body portion 02' are formed so as to be flexible, it is possible to use rouLer assembly 55 to remove impinging bone in a dynamic sense, i.e., to use the router asseinbly lo cut away impinging bone even as the knee is flexed through a full range of natural motions. See, for exainple, Figs.
19 and 20, where router assembly 55 is shown enlarging the SUBSTITUTE SHEET (RULE 26) femoral notcli while the patienL' s leg is benL at approximatel.y a 90 angle; Figs. 21 anci 22, where r.outer assembly 55 is sliown enlarging the femoral. noLch wliile Llie naL.ient's knee is substantially straiglit; and Fig. 23, where router assembly 55 is shown enlarging the femoral noLcli whi.le the patient's knee is bent at approxirnately a 140 angle. It should be noted in Figs.
21 and 22, and agaiii in Fig. 23, how guidewire 50 and router assembly 55 are capable of undergoing subsLantial elastic deformation during such knee flexing even as bone-trimming operaLions are under way.

Looking next aL Figs. 21-26, in another preferred einbodimenL
of the present invention, the apparatus oE ttie present invention comprises guidewire 50 and a router assembly 5511.

Router assembly 55A is substantially the same as router assembly 55 described above, except as is shown in the drawings and/or hereinafL'er described. In particular, router assembly 55A
utilizes a collar 0311 (Figs. 25 and 26) ratlicr than the coflar 03 described above. Collar II311 iias iLs iiol.e 90 clisposed off-center within Lhe.collar., whereby the routcr dcvice's cutting heaci 67 will be clocked to one side relative to the body's hollow outer tube 02 (see Fig. 26). In particular, wil.'h router assembly 55A, collar 83A is arranged so Lhat the router device's cutting head 67 is clocked outboard relative to the central axis of hollow outer tube 82. This perinits the router device to en.gage impinging bone more readily. In order to accommodate sucll SUBSTiTUTE SHEET (RULE 26) lateral displacement of router clevice 65, the router assembly's shield 0511 has its hole 95A sliifLed laterally as well, in the manner shown in Fig. 26.

In operation, router assembly 55A is intended to be used in substantially the same way as rouLer assembly 55.

Looking next at Fig. 27, in anol'her preferred embodiment of the present invention, Ltie apparatus of the present invention comprises guidewire 50 and a cannulated router device 65A.
Router device 65A is generally similar Lo the router device 65 discussed above, except L1iaL- wiLh router clevice 65A, its cutting teeth 09 are disposed about only a portion of the periphery of its cutting head 67A, witli Lhe remainder of the cutting head being smooth and non-abrasive. 1lccordirigly, by moving cannulated router device 65A on guidewir.-e 50 so as to oscillate the router device through only a fraction of a complete revolution, bone can be removed adjacent to the cutting teeth 89 while ttte remainder (i.e., the non-cutting portion) of the cutting head 67A safely opposes any delicate structures which are to be safeguarded (e.g., the PCL) . 'rhus, with Llie apparatus of Fig. 27, iinpinging bone may be safely removed without providing a sliield assembly (e.g., such as the shield assembly 75 described above) for the router device.

In another forin of the invention, the cannulated router device 65A of Fig. 27 could be replaced with a cannulated router device of the sort adapted to remove hard bone wliile leaving soft SUBSTITUTE SHEET (RULE 26) tissue unharmed. By way of example, the cannulated router device 65A of Fig. 27 might be replaced by the cannulated router device 65B shown in Fig. 28. More particularly, router device 65B
includes a cutting head 67B having an outer configuration similar to that disclosed in D.S. Patent No. 4,445,509 issued May 1, 1984 to David C. Auth for METHOD AND APPARATUS FOR REMOVAL OF ENCLOSED
ABNORMAL DEPOSITS. Alternativeiy, cutting head 67B could have some other configuration of the sort well known in the art which permits cutting of hard bone without harming soft tissue. As a result of such construction, a cannulated router device 65B
having such a configuration could then be safely rotated complemely about guidewire 50 so as to remove impinging bone without risking damage to delicate soft tissue. Thus, with the apparatus of Fig. 28 or with equivalent cutting apparatus, impinging bone can be safely removed without providing a shield assembly (such as the shield assembly 75 described above) for the router device.

The foregoing apparatus may be used in an ACL reconstruction procedure as follows. First, the patient's knee is extended at an angle of approximately 90 . Then, a bone tunnel 30 is formed in the tibia in ways well known in the art. Next, guidewire 50 is passed through bone tunnel 30 and up into the femur. Then a cannulated router device (in the form of either router assembly 55, or router assembly 55A, or router device 65A, or router device 65B) is loaded onLo gu.idew.ire 50 and used to perform Lhe desired notchplasty in the manner previously described. Next, the cannulated rouLer devicc is disinounLed from guidewire 50.
Then bone tunnel 35 is formed in femur 10 in ways well known in the art. 'I'hen guidewire 50 is removed from femur 10. Finally, a graft ACL 5A is installed i.n femoral bone Lunnel 35 and Libial bone tunnel 30 in ways well known in Liie art.

Looking next at Fig. 29, in anoLher preferred emboditnerit of the present invention, the apparatus o[ the present invention comprises guidewirc 50 and a mark.incl device 100. Marking device 100 preferably comprises a resilient cannu.laLed head 105 and a flexible cannulated shaft 110 connected to head 105. Cannulated liead 105 is formed so L11a1- it can tiold and release a dye without cutting bone. Marking clevice 100 is used by rnoving the device up and down guidewire 50, with or withouL rotation, whereby the marking head 105 will contacL any bone in its way. By sizing marking device 100 properly relative to Llie size of the graft ACL
which is to be installed, inoveinenL of marking device 100 along guidewire 50 while Lhe knee is moved tlii-ough a range of natural motions will cause ttie inar.king elemerit to leave i.ts dye on any portions of the feinur which migl-L iinpinge upon the graft ACL
which will thereafter be installed in the knee. Thereafter, marking devi.ce 100 and gui.dewire 50 are removed from the surgical site and the surgeon may utilize a converitional cutting element SUBSTITUTE SHEET (RULE 26) to remove the marked bone. Then L-he grafL ACL may be installed in ttie knee wiLl iouL fear of imhingemcnL.

In the forego.inq descr.ipt.i.on of Lhe preferred ernbodiinenLs of the invention, it was noted thaL guidewire 50 is preferably formed out of a pseudoelasLic inaterial so as Lo provide the desired characteristics of f.irinness and flexibility. llowever, it should also be appreciaL-ed that a guiciewire inade out of a non-pseudoelastic material can also be utilized in connection with the present invention. Of course, inasmuch as the preferred use of the present invenCion .i.nvo].ves flexing the knee over a wide range of inol'ions wiLli Lhe guidewire in place, limitations in wire flexibility can .i.nhi.biL the range of knee niovemenLs performed with the guidewire in place. 'P1-us, in the situation where a non-pseudoelastic guidewir.e .i.s to be used, it can be helpful to mount the distal end of Lhe guidewire in a fixture by ineans of a universal joint. This fixture can Ll1en be attached to the bottom surface of the femur or, more advantageously, it can be disposed in a bore formed in the boLtoin of the femur. Preferably this bore is the femoral bone Luiinel. 35 used for Lhe ACL
recoiistruction procedure.

More particularly, and looking now at Fig. 30, the distal end of a non-pseudoelastic guidewire 50A can be mounted in a fixture 115 by a universal joinL 120 wliereby the proximal end of the guidewire can move about relative to fixture 115. As a result of this construction, when fixture 115 is positioned in SUBSTITUTE SHEET (RULE 26) the femoral bone tunnel, universal joint 120 will help guidewire 50A to accommodate Lhe degree of deforrnaLion required as the knee is moved through a full range of natural motions. Of course, with this embodiment of the invenLion, the feinoral bone tunnel 35 must be formed before the notchplasLy procedure is performed, since fixture 115 is inteiided Lo be received in bone tunnel 35.
Modifications Of the Preferred Embodiments It is to be appreciated that nlodifications may be made to the preferred embodiments described and illusLrated above without departing from the scope of the presenL invention Thus, for exainple, while i.n Lhc foregoing description the present invention has been described in the context of reconstructing aii 11CL, it should also be appreciated that the present iizvention has application Lo tlie reconstruction of other ligaments as well, where similar iinpingement problems can occur.
Thus, for example, the presenL invention m.iglil' be used in connection with reconstructing tlie=poster.i.or cruciate ligament (PCL).

The present invention can also be used to clear away impinging structures in other anatoinical. and non-anatomical settings.

SUBSTITUTE SHEET (RULE 26) Advantages Of The .TnvenLion Numerous advanLages are achievecl througli Lhe use of the present invention.

I'or one thing, Llie presenL invention provides improved apparatus for reconstructing a ligainent.

And the presenL invenLion provides improved apparatus for reconstructing an anterior cruciate ligarnent (71CL).

Also, the present invenL.ion provides iinproved apparatus for quickly, easily and reliably climinating impingement problems when reconstructing an anterior cruciate ligainent.

And the present invenLion provides improved apparatus for quickly, easily and reliably removing any anatomical structures (e.g., bone) wi-iich will conflict wiLh the location of a graft ACL
at the completion of an ACI, reconstruction procedure.

The present invention also provides improved apparatus for quickly, easily and reliably removing any anatomical structures (e.g., bone) which will conflict witli the location of a grafC ACL
as the knee is moved tlirough a full r.aiige of natural motions.

The present invention also provides ai1 improved method for reconstructing a ligament.

And the present invention provides an improved method for reconstructing an anterior cruciate ligament (nCL).

]Vnd-the present invention provides aii improved method for quickly, easily and reliably eliminating impingeinent problems when reconstructing an anterior cruciate ligament.

SUBSTITUTE SHEET (RULE 26) Also, the present invenCion provides an improved method for quickly, easily and reliably removing any anatomical structures (e.g., bone) wllicti will conflict with the location of a graft ACL
at the completion of an ACL reconstruction procedure.

And the present invention provides aii improved method for quickly, easily and reliably removing any anatomical structures (e.g. bone) which will conflict with the location of a graft ACL
as the knee is moved thr.ough a full range of natural motions.

SUBSTITUTE SHEET (RULE 26)

Claims (14)

What is Claimed Is:
1. Apparatus for removing portions of a bone, said apparatus comprising:

a router assembly comprising:

a cutting head fixed to a shaft; and a shield assembly having a body portion and a hood portion, said body portion having a hole therethrough for receiving said shaft, the hole having a central axis extending lengthwise of the body portion, said central axis of the hole being removed from a central axis of the body portion, said hood portion extending from one end of said body portion and defining a concavity in which is disposable in part said cutting head.
2. Apparatus according to claim 1 wherein said cutting head and said shaft are provided with bores in alignment with each other and adapted to receive a guidewire therethrough.
3. Apparatus according to claim 2 wherein said hood portion is provided with a hole therein alignable with said cutting head bore and adapted to receive said guidewire.
4. Apparatus according to claim 1 wherein said body portion is cylindrically shaped.
5. Apparatus according to claim 1 wherein said hood portion encloses a first portion of said cutting head, and a second portion of said cutting head extends outwardly from said hood portion.
6. Apparatus according to claim 5 wherein a portion of the perimeter of said second portion of said cutting head is substantially aligned with a portion of the perimeter of said body portion.
7. Apparatus according to claim 5 wherein said first portion of said cutting head includes a majority of the circumference of said cutting head.
8. Apparatus according to claim 3 wherein said guidewire extends through said shaft, said cutting head and said shield hood portion hole, such that said shaft, said cutting head, and said shield assembly are movable along said guidewire to advance said router assembly along said guidewire.
9. Apparatus according to claim 5 wherein said shield assembly body portion comprises a collar within a sleeve, said body portion hole extending through said collar.
10. Apparatus according to claim 1 wherein at least a portion of said shaft is flexible.
11. Apparatus according to claim 1 wherein at least a portion of said shield assembly is flexible.
12. Apparatus according to claim 11 wherein at least a portion of said body portion is flexible.
13. Apparatus according to claim 1 further comprising a guidewire formed out of a pseudoelastic material.
14. Apparatus for removing portions of a bone, said apparatus comprising:

a guidewire; and a router assembly;

said router assembly comprising a cutting head fixed to a shaft rotatably disposed in a hole through a body portion of a shield assembly, the hole having a central axis extending lengthwise of the body portion, said central axis of the hole being removed from a central axis of the body portion, and a hood portion of said shield assembly extending from said body portion of said shield assembly and covering a first portion of said cutting head while leaving exposed a second portion of said cutting head;

said guidewire extending through a bore in said shaft, a bore in said cutting head, and a hole in said shield assembly hood portion, such that said router assembly is movable along said guidewire and said shaft is rotatable in said shield assembly body portion, such that said second portion of said cutting head is engageable with the bone and is operative to remove portions of the bone.
CA002257398A 1996-06-04 1997-06-03 Apparatus and method for reconstructing ligaments Expired - Fee Related CA2257398C (en)

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US08/658,003 US5755718A (en) 1996-06-04 1996-06-04 Apparatus and method for reconstructing ligaments
US658,003 1996-06-04
PCT/US1997/009431 WO1997046162A1 (en) 1996-06-04 1997-06-03 Apparatus and method for reconstructing ligaments

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JP (1) JP2000512171A (en)
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DE69737948T2 (en) 2008-04-03
US20040220576A1 (en) 2004-11-04
US5941883A (en) 1999-08-24
AU3152097A (en) 1998-01-05
WO1997046162A1 (en) 1997-12-11
CA2257398A1 (en) 1997-12-11
EP0910291A4 (en) 2004-12-22
US5755718A (en) 1998-05-26
EP0910291A1 (en) 1999-04-28
US6685709B2 (en) 2004-02-03
JP2000512171A (en) 2000-09-19
AU739665B2 (en) 2001-10-18
US6364886B1 (en) 2002-04-02
DE69737948D1 (en) 2007-09-06
US20020173795A1 (en) 2002-11-21
EP0910291B1 (en) 2007-07-25

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