REFERENCE TO RELATED APPLICATIONSThe present application is a continuation of U.S. Ser. No. 16/923,438, filed on Jul. 8, 2020 (published as U.S. Pat. Pub. No. 2020-0337743), which is a continuation of U.S. Ser. No. 15/368,797, filed on Dec. 5, 2016 (now U.S. Pat. No. 10,736,671), which is a continuation-in-part application of U.S. Ser. No. 15/265,083, filed Sep. 14, 2016 (now U.S. Pat. No. 10,136,928), all of which are hereby incorporated by reference in their entireties for all purposes.
BACKGROUNDField of the InventionThe present invention relates to bone fixation, and more specifically, to a rod link reducer that can be used during the correction of spinal deformities.
Description of the Related ArtIn severe spine deformity with coronal or sagittal decompensation, translation of the spinal column is necessary for restoration of trunk balance as well as deformity correction. However, the conventional correction methods, such as segmental reduction, global derotation, and apical translation, are usually unsatisfactory.
It would be beneficial to provide a rod link reducer assembly and method that provides a more direct and controlled approach to spinal correction.
SUMMARYThis Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.
According to one embodiment, a rod link reducer assembly may be configured to treat scoliosis. The rod link reducer assembly comprises a manipulator rod having a first end, a second end, and an elongate body extending along a body axis between the first end and the second end. A post extends outwardly from the rod. A rod manipulating joint comprise an elongate joint rod extending along a joint rod axis, a first coupling clamp disposed along the joint rod, the first coupling clamp releasably connectable to the post, and a second coupling clamp disposed along the joint rod adjacent to and rotatable about the joint rod relative to the first coupling clamp. The second coupling clamp is releasably connectable to a second post on a second manipulating rod. A biasing member is adapted to bias the second clamp against the first clamp.
Alternatively, a rod link reducer assembly comprises a manipulator rod having a first end, a second end, and an elongate body extending along a body axis between the first end and the second end. A handle is removably attachable to the first end of the manipulator rod. The handle is adapted to rotate the manipulator rod about the body axis. A tip is attached to the second end. The tip is sized to releasably receive and retain a rod inserted thereinto. A post extends outwardly from the rod between the first end and the second end. A rod manipulator joint is releasably attachable to the post. The rod manipulator joint comprises a joint rod, a first coupling clamp disposed along the joint rod and adapted to releasably retain the post, and a second coupling clamp disposed along the joint rod and rotatable relative to the first coupling clamp. A locking mechanism is adapted to releasably secure the first coupling clamp to the second coupling clamp.
BRIEF DESCRIPTION OF THE DRAWINGSOther aspects, features, and advantages of the present invention will become more fully apparent from the following detailed description, the appended claims, and the accompanying drawings in which like reference numerals identify similar or identical elements.
FIG.1A is a rear elevational view showing prior art provisional rods and rod-link reducers correcting the sagittal curve;
FIG.1B is a rear elevational view showing prior art provisional rods and rod-link reducers for correcting the sagittal curve;
FIG.2 is a perspective view of a pair of rod link reducer assemblies according to a first exemplary embodiment;
FIG.3 is a perspective view of a manipulating arm tip shown in the assemblies ofFIG.2;
FIG.4 is an alternative embodiment of a manipulating arm tip that can be used in the assemblies ofFIG.2;
FIG.5 is a sectional view of either of the manipulating arm tips shown inFIGS.3 and4;
FIG.6 is an exploded perspective view of one of the rod link reducer assemblies shown inFIG.2;
FIG.7 is an exploded perspective view of rod manipulator joint used in the rod link reducer assembly ofFIG.6;
FIG.8 is a side elevational view, in section, of the assembled rod manipulator joint shown inFIG.7, in a compressed condition;
FIG.9 is a side elevational view, in section, of the assembled rod manipulator joint shown inFIG.7, in an uncompressed condition;
FIG.10 is a side elevational view, in section, of an alternative assembled rod manipulator joint in a compressed condition;
FIG.11 is a side view of a coupling clamp with inner teeth; and
FIG.12 is a top perspective view of a shaft with star grind.
DETAILED DESCRIPTIONIn the drawings, like numerals indicate like elements throughout. Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present invention. The terminology includes the words specifically mentioned, derivatives thereof and words of similar import. The embodiments illustrated below are not intended to be exhaustive or to limit the invention to the precise form disclosed. These embodiments are chosen and described to best explain the principle of the invention and its application and practical use and to enable others skilled in the art to best utilize the invention.
Reference herein to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment can be included in at least one embodiment of the invention. The appearances of the phrase “in one embodiment” in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments necessarily mutually exclusive of other embodiments. The same applies to the term “implementation.”
As used in this application, the word “exemplary” is used herein to mean serving as an example, instance, or illustration. Any aspect or design described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other aspects or designs. Rather, use of the word exemplary is intended to present concepts in a concrete fashion.
Additionally, the term “or” is intended to mean an inclusive “or” rather than an exclusive “or”. That is, unless specified otherwise, or clear from context, “X employs A or B” is intended to mean any of the natural inclusive permutations. That is, if X employs A; X employs B; or X employs both A and B, then “X employs A or B” is satisfied under any of the foregoing instances. In addition, the articles “a” and “an” as used in this application and the appended claims should generally be construed to mean “one or more” unless specified otherwise or clear from context to be directed to a singular form.
Also for purposes of this description, the terms “couple,” “coupling,” “coupled,” “connect,” “connecting,” or “connected” refer to any manner known in the art or later developed of joining or connecting two or more elements directly or indirectly to one another, and the interposition of one or more additional elements is contemplated, although not required. Conversely, the terms “directly coupled,” “directly connected,” etc., imply the absence of such additional elements.
Unless explicitly stated otherwise, each numerical value and range should be interpreted as being approximate as if the word “about” or “approximately” preceded the value of the value or range.
The use of figure numbers and/or figure reference labels in the claims is intended to identify one or more possible embodiments of the claimed subject matter in order to facilitate the interpretation of the claims. Such use is not to be construed as necessarily limiting the scope of those claims to the embodiments shown in the corresponding figures.
Severe scoliosis can be treated by using a technique known as reduction by a rod link reducer. In this procedure, shown inFIG.1A, a rod link reducer is capable of manipulating a first temporary rod via a first manipulating arm and a second temporary rod via a second manipulating arm to temporarily correct a deformity. With the deformity temporarily corrected, a rod link is positioned between the first manipulating arm and second manipulating arm, whereby it is locked in place by tightening the first rod joint and the second rod joint. With the rod link in place, as shown inFIG.1B, a permanent rod can then be placed on the opposite side of the spine to maintain the deformity correction.
Another known procedure includes a resection that is typically made in the vertebrae. The rod link reducer is used to manipulate the position of the vertebrae via fixation by temporary rods and the rod link. With the vertebrae manipulated into a desired anatomy, a permanent rod can be inserted thereby retaining the desired anatomy.
It would be beneficial to provide a rod link reducer assembly that permits simultaneous, controlled correction of a deformed spine in all planes of motion. In addition, it would be beneficial to provide a reducer with various tips that allow for the attachment of multiple rod sizes, allow for attachment around a screw head or between rods, and has a decreased profile.
The present disclosure provides embodiments of rod link reducer assemblies that can be used to alleviate severe scoliosis. According to one embodiment, a rod link reducer assembly may include two or more manipulating arms having a distinct rod gripping tip, and a manipulating joint having a locking mechanism.
Referring toFIGS.2,3, and5-9, a rod link reducer assembly100 (“reducer assembly100”) and a rodlink reducer assembly100′ (“reducer assembly100′”) according to a first exemplary embodiment are shown.Reducer assembly100 is connected to arod50 in an existingconstruct52 andreducer assembly100′ is attached to arod50′ in another existingconstruct52′. Whilereducer assemblies100,100′ are shown, becausereducer assembly100′ is constructed from the same assembly components asreducer assembly100, onlyreducer assembly100 will be discussed in detail.
Assembly100 is used to correct a spinal deformity by allowing the manipulation of temporary rods above and below the apex of the deformity to move the spine into a corrected state. The position of the rods is then locked and a permanent rod is then placed on the contralateral side of the spine to hold the correction.
Assembly100 also permits simultaneous, controlled correction of a deformed spine in all planes of motion whereas prior art devices require multiple separate instruments for lateral-medial reduction, anterior-posterior reduction, and axial de-rotation.Assembly100 simplifies such procedures and provides a new method of correcting simplex sagittal and kyphotic deformities.
In addition,assembly100 can be provided with various tips that allow for the attachment of multiple rod sizes, allow for attachment around a screw head or between rods, and have a decreased profile. Manipulating arms ofassembly100 provide a more rigid coupling surface with the medial-lateral arm and an orientable attachment for a handle for surgeon preference.Assembly100 can be disassembled and attached to the manipulating arm and provides sufficient angulation so thatassembly100 can be combined with translating arms to simplify the surgical procedure.
Referring toFIGS.2 and6,assembly100 includes amanipulator rod110 having afirst end112, asecond end114, and anelongate body116 extending along abody axis118 betweenfirst end112 andsecond end114.First end112 ofmanipulator rod110 has afaceted interface120.
Ahandle130 is removably attachable tofirst end112 ofmanipulator rod110. Handle130 is adapted to maneuvermanipulator rod110 as desired by the surgeon. Handle130 has a faceted bore, or receiver,132 adapted to receivefaceted interface120 of the first end. In an exemplary embodiment,faceted interface132 has eight sides such that handle130 can be rotated in 45 degree increments aroundmanipulator rod110 according to surgeon preference (e.g., right-handed or left-handed use) or to accommodate the patient's anatomy. While eight facets are disclosed, those skilled in the art will recognize that a different amount of facets, such as, six facets (allowing for rotation ofhandle130 aboutmanipulator rod110 in 60 degree increments), can be used as well.
Afree end134 ofhandle130 is sized to allow the surgeon to comfortably griphandle130 for use.Free end134 may includecontours136 to enhance the ergonomics ofhandle130.
Referring now toFIGS.2,3,5, and6,second end114 ofmanipulator rod110 comprises atip140.Tip140 comprises areceiver142 adapted to releasably secure a construct50 (shown inFIG.2) therein.Tip140 comprises areceiver axis144 extending throughreceiver142. In an exemplary embodiment,receiver axis144 extends orthogonally tobody axis118.Tip140 is sized to releasably receive and retainrod50 inserted thereinto.
Receiver142 has anopening146 with a length “A” that is larger than the diameter ofrod50 to be inserted intoreceiver142. To retainrod50 withinreceiver142,receiver142 includes a securingmember148 extending along anaxis150 at an angle oblique toreceiver axis144. Securingmember148 includes a set screw152 engaged with a threaded passage154 and retainer pins156,158 located in passage154 to prevent removal of set screw152 from passage154. The oblique angle of set screw152 allows set screw152 to be tightened from the contralateral side of the patient, resulting in less interference with the anatomy (e.g., running into facet joints). Pins156,158 retain set screw152 while permitting sufficient motion to clamp a range of rod sizes.
Several different tip options are available for varying temporary rod diameters—a double tip140 (shown inFIG.3) can be provided to fit around ascrew60, as shown inFIG.2. In an alternative embodiment, asingle tip140′ (shown inFIG.4) can be provided to fit between two screws.
Regardless of whethertip140 or tip140′ is used,rod50 is accepted intotip140,140′ viaopening146, thereby allowingtip140,140′ to be inserted downwardly ontorod50 as viewed inFIG.2, and secured torod50 by tightening set screw152 againstrod50.
Referring now toFIG.6, apost160 extends outwardly frommanipulator rod110 betweenfirst end112 andsecond end114. In an exemplary embodiment, post160 is a medial-lateral post.Post160 is fixedly connected tomanipulator arm110 and is used to improve the ease of connection of rod manipulating joints ontomanipulator rod110 and to improve the rigidity ofassembly100.Post160 allows for intraoperative versatility ofassembly100 to affixmanipulator rod110 andshaft80 in desirable orientations. Further, the orientation ofpost160 allows for a clamp to clamp thereon, as will be discussed in detail below, so thatassembly100 can be more rigid in the direction where a corrective force on the patient's spine is required. Alternatively, rod manipulating joints can be connected directly tomanipulator rod110.
Post160 has aconnected end162 that is connected tomanipulator rod110 and afree end164 having a larger cross-section thanconnected end162. In an exemplary embodiment, post160 has a generally cylindrical cross section, andsecond end164 can be outwardly flared to prevent a connection thereon from sliding offpost160.
Referring now toFIGS.6-9, a rod manipulator joint170 is releasably attachable to post160. Rod manipulator joint170 includes an elongatejoint rod172 that extends along ajoint rod axis174.Joint rod172 includes asuperior end176 that has a threadedportion178 that is disposed inferiorly of asuperior tip180. Aninferior end182 includes acap183 that prevents elements onjoint rod172 from sliding offjoint rod172. As shown inFIGS.8 and9,cap183 includes aninternal hex185 allows a tool (not shown) to be inserted therein to securejoint rod172 withinrod manipulator joint170.Joint rod172 prevents disassembly of rod manipulator joint170 and maintains axial alignment of the components ofrod manipulator joint170.
Rod manipulator joint170 also includes afirst coupling clamp184 disposed alongjoint rod172.First coupling clamp184 is releasably connectable to post160. Whilefirst coupling clamp184 is separate frommanipulator rod110, those skilled in the art will recognize thatfirst coupling clamp184 can be integrated withmanipulator rod110, such as is disclosed in U.S. Patent Application Publication No. 2012/0221057, which is incorporated herein by reference, thereby making such an assembly quicker to assemble, less fidgety, and more rigid.
Asecond coupling clamp186 is disposed alongjoint rod172 adjacent to and rotatable aboutjoint rod axis174 relative tofirst coupling clamp184.Second coupling clamp186 is releasably connectable to a post or shaft, such asshaft80 shown inFIG.2. Whilefirst coupling clamp184 is shown coupled to post160 andsecond coupling clamp186 is shown coupled to post orshaft80, those skilled in the art will recognize thatfirst coupling clamp184 can be coupled toshaft80 andsecond coupling clamp186 can be coupled to post160, depending on the anatomy of the patient and the type of spinal correction required.
First coupling clamp184 comprises a first coupler end188 andsecond coupling clamp186 comprises asecond coupler end190 that is adapted to releasably engage first coupler end188, thereby restricting rotation of the first coupling clamp with respect to the second coupling clamp. Coupler ends188,190 can be mating star grind surfaces that are engageable with each other to restrict rotation of coupling clamps184,186 with respect to each other.
Each offirst coupling clamp184 andsecond coupling clamp186 includes asuperior clamp portion192,194, respectively, and aninferior clamp portion196,198, respectively, that is movable alongjoint rod axis174 relative to respectivesuperior clamp portions192,194. Referring specifically toFIG.9, eachsuperior clamp portion192,194 comprises afirst clamping surface200,202, respectively, extending at a first angle oblique tojoint rod axis174 and asecond clamping surface204,206, respectively extending at a second angle oblique tojoint rod axis174. Similarly, eachinferior clamp portion196,198 comprises afirst clamping surface208,210, respectively, extending at a first angle oblique tojoint rod axis174 and asecond clamping surface212,214, respectively extending at a second angle oblique tojoint rod axis174. The clamping surfaces on each clamp portion192-198 form generally “V-shaped” surfaces that provide four lines of contact with theirrespective post160 orshaft80, as shown inFIG.8.
Referring back toFIG.7, eachsuperior clamp portion192,194 includes one of atab220 and aslot222, while eachinferior clamp portion196,198 includes the other of aslot224 and atab226 such that eachtab220,226 engages arespective slot222,224 and prevents rotation ofsuperior clamp portion192,194 relative to itsinferior clamp portion196,198.
A first biasing member in the form of aclamp230 is adapted to releasably secure and biassecond coupling clamp186 againstfirst coupling clamp184.Clamp230 includes alever232 having afree end234 and acam236, distal fromfree end234, that is rotatably connected tojoint rod172.Cam236 allows for quick release of coupling clamps184,186 when desired.
Cam236 is operable between a secure position whereinfirst coupling clamp184 is non-rotatable relative to second coupling clamp186 (as shown inFIG.7) and a released position whereinfirst coupling clamp184 is rotatable relative to second coupling clamp186 (as shown inFIG.8).
Cam236 includes apassage240 through which acam axle242 extends.Cam axle242 includes a transverse threadedpassage244 that is threaded onto threadedportion178 ofjoint rod172 to securelever232 ontojoint rod172.Passage240 is off-center withincam236 such that, aslever234 is rotated between the positions shown inFIGS.8 and9,cam236 alternates between a secure position and a release position. Whencam236 is in the secure position,first coupling clamp184 securely engagespost160 and whencam236 is in the released position,first coupling clamp184 is removable frompost160.Cam236 engages a concave cam surface246, which transmits the compressive action ofcam236 to awasher248 on whichfirst coupling clamp184 pivots.
Rod manipulating joint170 further includes a second biasing member in the form of ahelical spring250 that is located betweenfirst coupling clamp184 andsecond coupling clamp186.Spring250 is adapted to biasfirst coupling clamp184 away fromsecond coupling clamp186 whencam236 is in the release position to allow for the insertion and/or removal ofpost160 andshaft80.
Inferior clamp portion196 offirst coupling clamp184 includes asuperior recess252 andsuperior clamp portion194 ofsecond coupling clamp186 includes aninferior recess254 that receivespring250 when rod manipulating joint170 is in the secure position.
To useassembly100, tip140 (or140′) is inserted overrod60 that is already part of a construct that is attached to a patient and setscrew146 is tightened to securetip140 torod60. Handle130 is inserted overfirst end112 ofmanipulator rod110 and rotated aboutrod axis118 to locatepost160 in a desired position relative to the anatomy of the patient.
Withlever232 rotated to the release position, as shown inFIG.9, first and second coupling clamps184,186 are open sufficiently to allowfirst coupling clamp184 to be inserted overpost160. Additionally, both first and second coupling clamps184,186 can be rotated relative tojoint rod172 and to each other to accommodate the anatomy of the patient.Shaft80 can be inserted intosecond coupling clamp186 andlever232 can be rotated to the position shown inFIG.8, forcingcam236 downward, lockingpost160 withinfirst coupling clamp184,shaft80 withinsecond coupling claim186, and engaging star grind surfaces of coupler ends188,190 to restrict rotation of first and second coupling clamps184,186.
FIG.10 is a side elevational view, in section, of an alternative assembled rod manipulator joint in a compressed condition. The advantage of the alternative assembled rod manipulator joint270 is that is can better grip a post or shaft. The rod manipulator joint270 shares similar features to the rod manipulator joint170 shown inFIG.7, including an elongatejoint rod172, afirst coupling clamp184, asecond coupling clamp186, and a biasingmember230. Thefirst coupling clamp184 includes asuperior clamp portion192 and aninferior clamp portion196 for gripping a shaft or post160 therein. Similarly, thesecond coupling clamp186 includes asuperior clamp portion194 and aninferior clamp portion198 for gripping a post orshaft380 therein.
In addition to these similar features, the alternative rod manipulator joint270 also includes additional features. In particular, the alternative rod manipulator joint270 has been modified such that its lower,second coupling clamp186 now includesinner teeth308 which can be used to engage ashaft380 therein having an outer surface in the form of astar grind382. By providing these features, thesecond coupling clamp186 is advantageously capable of gripping thestar grind382 surface of theshaft380 with reduced risk of slippage. In addition, these features eliminate the need for a clamp with a four point contact (as is still shown in thefirst coupling clamp184 inFIG.10), though both types of clamps can be used as part of therod manipulator joint270. And, while in the present embodiment, the lower,second coupling clamp186 is identified as havinginner teeth308, while the upperfirst coupling clamp184 relies on a four point contact to hold a post or shaft therein, in other embodiments, theupper coupling clamp184 can includeinner teeth308 while thesecond coupling clamp186 can include a four point contact.
FIG.11 is a side view of a coupling clamp with inner teeth. In particular, it is a side view of thesecond coupling clamp186 includinginner teeth308a,308bfor engaging the post orshaft380. In some embodiments, thesecond coupling clamp186 comprises asuperior clamp portion194 including a first set ofteeth308a, as well as aninferior clamp portion198 including a second set ofteeth308b. In some embodiments, the inner teeth need only be formed on one or the other of thesuperior clamp portion194 or theinferior clamp portion198.
As shown inFIG.11, thesuperior clamp portion194 of thesecond coupling clamp186 also comprises astar grind306 on its upper surface. In some embodiments, thestar grind306 can engage an opposing surface (e.g., another star grind) on theinferior clamp portion196 of thefirst coupling clamp184. When thefirst coupling clamp184 andsecond coupling clamp186 are brought together, as inFIG.10, the engaging star grinds advantageously rotationally fix theclamps184,186 with respect to one another.
FIG.12 is a top perspective view of a shaft with star grind. As shown inFIG.12, thestar grind382 extends in parallel along a longitudinal axis of theshaft380. In some embodiments, thestar grind382 extends around an entire diameter of theshaft380, while in other embodiments, thestar grind382 extends only partially around a diameter of theshaft380.
It will be further understood that various changes in the details, materials, and arrangements of the parts which have been described and illustrated in order to explain the nature of this invention may be made by those skilled in the art without departing from the scope of the invention as expressed in the following claims.