Length adjustable modular screw system
11633220 · 2023-04-25
Assignee
Inventors
Cpc classification
A61B17/7082
HUMAN NECESSITIES
A61B17/7032
HUMAN NECESSITIES
A61B2017/8655
HUMAN NECESSITIES
A61B17/7035
HUMAN NECESSITIES
A61B17/863
HUMAN NECESSITIES
A61B17/7037
HUMAN NECESSITIES
International classification
Abstract
A length adjustable modular screw includes a neck assembly and a shank. The neck assembly has proximal and distal ends and includes an expander component and a collet component that are slidably engagable by insertion of the expander component in a through channel of the collet component along a common axis. The length adjustable modular screw also includes a shank suitable for insertion and retention within a bone, the shank including a threaded portion between proximal and distal ends and a socket adapted to coaxially receive at least a portion of the distal end of the neck assembly. The length adjustable modular screw has a length that is selected by splaying at least a portion of the distal end of the engaged expander and collet components of the neck assembly within the socket of the shank.
Claims
1. A surgical method for installing a bone anchor system for spinal fixation, comprising: (i) selecting each of: (a) a length adjustable modular screw comprising: a neck assembly that includes an expander component and a collet component, the neck assembly having proximal and distal ends and including expander and collet components that are slidably engagable by insertion of the expander component in a through channel of the collet component along a common axis, and a shank suitable for insertion and retention within a bone, the shank including a threaded portion between its proximal and distal ends and a socket adapted to coaxially receive at least a portion of the distal end of the neck assembly, wherein the length adjustable modular screw has a length that is selected by splaying at least a portion of the distal end of the engaged expander and collet components of the neck assembly within the socket of the shank, wherein the length adjustable modular screw is one of monoaxial, uniaxial, and poly-axial; and (b) at least one spinal rod defining a longitudinal axis; (c) two or more retaining housings, each retaining housing adapted for engaging and securing a bone anchor and the at least one spinal rod; (d) two or more locking elements, each locking element adapted for securing the at least one spinal rod to a bone anchor (ii) either before or after seating the neck assembly in a retaining housing, assembling a length adjustable modular screw, comprising the steps of: (a) engaging the components of the neck assembly into engagement, and inserting the neck assembly into the socket of the shank, (b) contacting the distal end of the shank with a bone, (c) with a suitable driver, engaging a drive recess of the neck assembly to splay at least a portion of the distal end of the engaged expander and collet components of the neck assembly within the socket of the shank, (d) driving the threaded portion of the shank into the bone, (e) either before or after provisionally securing the at least one spinal rod into the retaining housing, adjusting the length of the length adjustable modular screw by sliding the neck assembly along the common axis within the socket of the shank; tightening one of the locking elements within the retaining housing to compress the at least one spinal rod against the neck assembly and to lock the neck assembly within the socket of the shank.
2. The surgical method according to claim 1, wherein the length adjustable modular anchor system is fully assembled prior to engagement of the threaded portion of the shank with the bone.
3. The surgical method according to claim 1, wherein the length adjustable modular anchor system is provided pre-assembled.
4. The surgical method according to claim 1, wherein the first expander component of the neck assembly includes an extension that extends beyond the distal end of the collet component of the neck assembly.
5. The surgical method according to claim 1, wherein the expander and collet elongate components are matable at their proximal ends when the expander component is inserted in the through channel of the collet component.
6. The surgical method according to claim 1, wherein the expander component comprises a head at its proximal end and the collet component comprises a seat at its proximal end, wherein the head and seat, when mated form a generally spherical head on the neck assembly.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) Various embodiments of the disclosed inventions will now be discussed with reference to the appended drawings. These drawings merely depict representative embodiments and are not limiting in scope.
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(9) TABLE-US-00001 Table of Reference Numerals length adjustable modular anchor system 10 through slot 452 retaining housing 20 interference enhancer 454 (e.g., compression washer 30 (e.g., cap) groove/furrow/ rib) locking element 40 (e.g., set screw) leg 456 rod (not shown) compression element 460 complementary taper 462 length adjustable modular screw 100 shaped recess 470 neck assembly 200 recess proximal stop 472 recess distal stop 474 expander component 300 outer surface 480 head 310 (hemispherical) chamfered corners 482 foot 320 collet cross sectional shape 490 (e.g., square) foot cross sectional shape 322 pin 330 shank 500 threaded portion 510 taper 332 proximal end 520 extension 334 proximal aperture 522 circumferential flange 340 proximal thread zone 524 flange generally planar surface 345 distal end 530 flange taper 347 distal tip 532 detent region 350 distal thread zone 534 drive recess 360 (hex) socket 540 pin 330 socket cross sectional shape 542 (e.g., sq/cyl) cross sectional shape 370 e.g., (sq/cyl) chamfered sidewall 544 wall 550 collet component 400 wall aperture 560, 560′ proximal end 410 protuberance 570, 570′ distal end 420 floor 580 through channel 430 floor taper 582 inner wall 431 diameter 590 (e.g., straight, tapered, step down) inner wall cross sectional shape 432 major diameter 592 (cylindrical) minor diameter 594 seat 440 (hemispherical) cannula 596 seat recess 441 flange 598 seat recess cross sectional shape 442 e.g., (sq/cyl) collet 450
DETAILED DESCRIPTION
(10) This Detailed Description describes exemplary embodiments in accordance with the general inventive concepts and is not intended to limit the scope of the invention in any way. Indeed, the invention as described in the specification is broader than and unlimited by the exemplary embodiments set forth herein, and the terms used herein have their full ordinary meaning.
(11) The general inventive concepts will now be described with occasional reference to the exemplary embodiments of the invention. This general inventive concept may, however, be embodied in different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the inventive concepts to those skilled in the art.
(12) Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art encompassing the general inventive concepts. The terminology set forth in this detailed description is for describing particular embodiments only and is not intended to be limiting of the general inventive concepts. As used in this detailed description and the appended claims, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise.
(13) The term “proximal” as used in connection with any object refers to the portion of the object that is closest to the operator of the object (or some other stated reference point), and the term “distal” refers to the portion of the object that is farthest from the operator of the object (or some other stated reference point). A “clinical subject” refers to a human or other animal who is the subject of treatment with a bone fixation or reduction device in accordance with the disclosure. With respect to any references herein that may be made relative to a clinical subject, the term “cephalad” indicates a direction toward the head of the clinical subject, and the term “caudad” indicates a direction toward the feet of the clinical subject. The term “posterior” indicates a direction toward the back of the clinical subject, the term “anterior” indicates a direction toward the front of the clinical subject, and the term “lateral” indicates a direction toward a side of the clinical subject.
(14) The term “height” as used specifically herein pertains to references to the spine of a clinical subject and refers to the relative position of one or both of vertebrae and anchors along adjacent portions of the spine. Likewise, the terms “vertical” and “vertical adjustment” relate to the relative height variations and adjustments thereof with respect to one or both of vertebrae and anchors along adjacent portions or the length of the spine in the context of a clinical subject in a prone position wherein a length adjustment to an anchor would be in a vertical dimension from anterior to posterior. These descriptors are not intended to be limiting with respect to embodiments of the modular adjustable assemblies, subassemblies and components according to the instant invention that are useful outside of the spine and may more generically be substituted with alternate descriptors including “length” and “length adjustment” where orientation of the clinical subject or body part and bones and implants vary.
(15) As used herein in the described and illustrated embodiments, the term anchor typically refers to the screw component of an anchor assembly or subassembly, and the term anchor assembly refers to the screw component together with attachment features, such as a retaining housing (a conventional tulip head) or other type of attachment device, and one or more of compression washers and set screws, and optionally additional fixation components. Subassemblies also refer to the modular components of the screw, such as, for example, the shank and head portions and subassemblies of these. More generically, anchor components, subassemblies and assemblies can be adapted to include features suitable for use with any bones in a clinical subject, wherein the modular and adjustable features are as described and claimed herein.
(16) Unless otherwise indicated, all numbers expressing quantities of materials, properties such as length, diameter, and so forth as used in the specification and claims are to be understood as being modified in all instances by the term “about.” Accordingly, unless otherwise indicated, the numerical properties set forth in the specification and claims are approximations that may vary depending on the suitable properties sought to be obtained in embodiments of the present invention. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the general inventive concepts are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical values, however, inherently contain certain errors necessarily resulting from error found in their respective measurements.
(17) Referring now to the drawings, an embodiment of a modular and length adjustable modular anchor system 10 for securing a bone stabilization element, such as a spinal stabilization rod, to a bone is depicted in
(18) In accordance with the depicted embodiments, the length adjustable modular screw 100 is assembled to provide a construct that resembles a convention screw that includes a head 310 portion including at a proximal end 410 a hemispherical screw head and a separate threaded shank 500 portion including at a distal end a threaded shank 500. In accordance with the disclosure, the length adjustable modular screw 100 components are adapted for interconnection along a common elongate axis and capable of vertical displacement to achieve fixed or variable length when implanted in a bone. In conventional pedicle screw anchors, pressure from the rod locked into the retaining housing 20 (tulip head) by a threaded nut results in displacement of the compression washer 30 within the tulip head 20 and compression on the head of the screw thereby transferring compressive force onto the screw, fixing it into place within the tulip head 20 and preventing any axial rotation (for uni- and poly-axial assemblies).
(19) Length Adjustable Modular Anchor System
(20) Provided in alternate embodiments is a length adjustable modular anchor system 10 for engagement with a bone. In one embodiment, as shown in
(21) The expander component 300 and the collet component 400 are engagable in each of open, mated and compressed configurations. In the open configuration, the expander component 300 and the collet component 400 are engaged without the head 310 contacting the seat 440 and the pin 330 of the expander component 300 is coaxially engaged with and only partially inserted in the through channel 430 of the collet component 400 and the expander and collet components 300, 400 are freely movable along the common axis.
(22) In the mated configuration, as shown in
(23) Referring now to
(24) As shown in the drawings, in some embodiments the head 310 of the expander component 300 includes a foot 320 having a generally square cross sectional shape, and the seat 440 of the collet component 400 includes a complementary seat recess 441 having a generally square cross sectional shape for receiving the foot 320 of the extender component 300.
(25) In the various embodiments, the collet 450 includes at least one through slot 452 oriented parallel to the common axis and along at least a portion of the collet 450 through the distal end 420. And in some embodiments the collet 450 includes a plurality of through slots 452 arranged circumferentially around the collet 450 and extending along at least a portion of the length of the collet 450 and through the distal end 420. As shown in the drawings, for example
(26) It will be appreciated that a variety of conventional features of collets 450 are known in the art and may be selected to facilitate locking and compression and/or frictional engagement between a collet 450 and engaged anchor components. In some instances, variations in the thickness of walls 550 of one or more components can be employed to achieve compressive engagement. In other examples, collet 450 features may include tapers along the length of engaging components. It will be understood that the features described herein are intended to be non-limiting and other features of collets 450 known in the art may be used to achieve the inventive modular and adjustable anchors in accordance with the invention.
(27) In some embodiments, at least one of the expander component 300 and the collet component 400 includes a locking feature that is engagable when the head 310 of the expander component 300 and the seat 440 of the collet component 400 are mated 220. In some such embodiments, as is shown, for example in
(28) In some embodiments, the pin 330 of the expander component 300 also includes a detent region 350, which is shown in
(29) As shown in the drawings, for example in
(30) Referring again to the drawings, for example
(31) It will be appreciated that in other embodiments, the expander component 300 and the collet component 400 may include features that engage to mate and compress that are located at positions other than as shown in the drawings. For example, one or more of the circumferential flange 340 and the detent region 350 and the taper 332 on the pin 330 may be positioned more proximally or more distally, and the pin 330 may not include an extension beyond one or more of the circumferential flange 340 and the detent region 350 and the taper 332. Likewise, one or more of compression elements 460 may be positioned more proximally or more distally within the through channel 430 of the collet component 400.
(32) As shown in the drawings, the expander component 300 pin 330 includes a conical taper 332 between the detent region 350 and a proximal portion of the pin 330, wherein the one or more compression elements 460 of the collet 450 comprises a complementary taper 462, which complementary taper 462, when pressed against the detent region 350 proximal taper 332 of the pin 330, splays the collet 450.
(33) Referring now to
(34) In the various embodiments, the threaded portion 510 of the shank 500 may be continuous from the proximal to the distal ends 520, 530, or there may be a gap at either end that lacks threading, or a gap along the length that lacks threading. In the various embodiments, the shank 500 includes at least a major and a minor diameter 592, 594, the minor diameter 594 defined by the outer surface of the shank 500 wall 550 excluding the threads, and the major diameter 592 defined by the threads. In some embodiments, one or both of the major and minor diameters 592, 594 may be straight or may be tapered. In some embodiments, there may be a step down from proximal toward distal such that there may be more than one major diameter 592 and/or more than one minor diameter 594. In some embodiments, at least a portion of the length of the shank 500 may taper from proximal to distal either continuously or may taper in a stepped down manner. In some embodiments, the threading may vary to provide a proximal thread zone 524 that is different from a distal thread zone 534.
(35) Referring again to the drawings, the depicted collet has a cross sectional shape 490 that is generally square and the socket 540 of the shank 500 has a socket cross sectional shape 542 that is square, each of the collet 450 and the socket 540 including chamfered corners 482 and chamfered sidewalls 544, respectively. It will be appreciated that in other embodiments, each of the collet cross sectional shape 490 and the socket cross sectional shape 542 may be other than square and may be cylindrical.
(36) As shown, for example in
(37) In accordance with some embodiments, the length adjustable modular screw 100 further includes at least one locking feature on at least one of the neck assembly 200 and the shank 500 that engages to retain the neck assembly 200 within the shank socket 540. Referring now to
(38) Other features of the neck assembly 200 engage with the shank 500 to further stabilize the engagement. Referring again to the drawings, the expander component pin 330 includes an extension 334 at its distal end, and the shank socket 540 includes a floor 580 and cannula 596 extending from the floor 580 towards the distal end 530. The distal end 420 of the collet 450 contacts the floor 580 to limit the distal passage of the neck assembly 200 within the socket 540, and the cannula 596 is adapted to receive the expander component 300 extension which aids in stabilizing against off axis motion of the neck assembly 200 relative to the shank 500. In some embodiments, the length of each of the extension of the expander component 300 and the shaped recess 470 of the collet 450 are selected such that when the neck assembly 200 is displaced proximally to the limit of the distal stop 474, the extension is retained in the cannula 596 to maximize off axis stabilization together with restriction on axis pull out. As is shown in the drawings, the floor 580 of the shank 500 has a generally conical floor taper 582. In some embodiments, the floor 580 may have another shape, and may be planar, or have a spherical contour or another shape.
(39) It will be appreciated that in alternate embodiments different or additional engagement features may be used that achieve the fixed engagement between subcomponents. Such engagement is useful to enable torsional engagement and actuation, such as with a driving tool, of one or more components while preventing other components from experiencing torsional force. Likewise, it is advantageous to employ engagement features that serve as stops to prevent disengagement of components by the application of shear force, such as pull out of axially aligned components.
(40) Referring again to
(41) Also provided according to the disclosure is a surgical method for installing a bone anchor system for spinal fixation. According to the method, the steps include in some embodiments selecting each of two or more bone anchors, at least one of which bone anchors is a length adjustable modular anchor system 10 that includes a neck assembly 200 and a shank 500, as described herein above, and at least one spinal rod defining a longitudinal axis, and two or more retaining housings 20 for engaging and securing a bone anchor and a surgical rod, and two or more locking elements 40 for securing a rod to a bone anchor, and optionally, one or more compression washers 30 for engagement between a rod and a bone anchor. Further according to the method, the steps include, either before or after seating the neck assembly 200 in a retaining housing 20, assembling a length adjustable modular screw 100 system.
(42) The steps for assembling a length adjustable modular screw 100 system include first engaging the expander and collet components 300, 400 of the neck assembly 200 into one of open and mated 220 engagement, and inserting the neck assembly 200 into the shank 500 socket 540, then contacting the distal tip 532 of the shank 500 with a bone. Thereafter, using a suitable driver, engaging the drive recess 360 of the neck assembly 200 to compress the expander and collet components 300, 400 and splay the collet 450. Thereafter, under continued compression, driving the threaded portion 510 of the shank 500 into a bone. Once the shank 500 is inserted to the desired depth in bone, the steps include releasing the drive compression on the drive recess 360 of the neck assembly 200 to thereby relieve the collet 450 from being splayed and thereby allowing translation of the neck assembly 200 within the shank 500.
(43) Thereafter, either before or after provisionally securing a surgical rod into the retaining housing 20, the vertical height (length) of the length adjustable modular anchor system 10 may be adjusted by sliding the neck assembly 200 along the common axis within the socket 540 of the shank 500. Once the desired length and vertical height relative to adjacent anatomy and/or other anchors or implants is selected, the method includes tightening the fixation element within the retaining housing 20 to compress the rod against the neck assembly 200 and to drive the expander component 300 and the collet component 400 into compressed engagement to splay the collet 450 within the socket 540 of the shank 500.
(44) In some embodiments of the surgical method, the length adjustable modular anchor system 10 is fully assembled prior to engagement of the threaded portion 510 of the shank 500 with bone. In yet other embodiments, the length adjustable modular anchor system 10 is provided pre-assembled. And in yet other embodiments, at least the neck assembly 200 of the length adjustable modular anchor system 10 is provided pre-assembled with a retaining housing 20.
(45) In some embodiments, the length adjustable modular screw 100 can be adjusted within a displacement range between zero mm to 20 mm, and more particularly 0 mm to 10 mm, including fractional increments therein, including 0.1, 0.2, 0.3, 0.4, 0.5, 1.0, 1.5, 2.0, and 2.5 up to and through 20.0 mm. Of course, other increments and ranges of travel are possible, and implementation thereof is well within the skill in the art.
(46) It will be appreciated that in each of the various embodiments according to the invention, more than one length adjustable modular screw may be provided that are of varying lengths and therefore allow for an expanded range of length adaptability. Whether the length adjustable modular screw components are of fixed length or offered in ranges of lengths, such possible embodiments are particularly advantageous in that they provide options in some embodiments for providing preassembled bottom and top loading anchor assemblies, as well as anchor assemblies and subassemblies that may be assembled partially by the manufacturer or partially or completely by the surgeon, providing a range of options for achieving maximal flexibility in the surgical setting.
(47) As described herein in accordance with the depicted embodiments, the components of the length adjustable modular screw 100 assembly that achieve locking of the length adjustable modular screw 100 to a rod can also actuate the collet 450 locking mechanism for fixing the neck assembly 200 of the length adjustable modular anchor system 10 to the shank 500 and optionally fixing the vertical position of the length adjustable modular screw 100 relative to the vertebra and the fixation system elements. Of course, in other embodiments, the means of achieving locking may be other than compression by the rod, and in yet other embodiments the locking means may be the same but the specific elements, such as the locking element 40, rod and compression washer 30, may be varied.
(48) Reference is made herein to fixation systems that include in the depicted embodiments anchors in the form of vertebral pedicle screws, and stabilization elements in the form of one or more surgical rods. It will be appreciated by those skilled in the art that the spine is but one example of a bone or bone system that may be the object of surgical correction, and thus, pedicle screws and rods are mere examples of the bone anchor, and vertebral stabilization system components contemplated herein. In other examples, anchors may be screws for engagement with a tether or other tensioning means, or with one or more plates or rods or combinations of these. And anchors and systems described herein may be suitable for other bones and bone systems in the body. Moreover, it will be appreciated that the mechanisms for adjustment of anchor length can be adapted for use with other anchor and fixation and stabilization elements used in orthopedic applications in the spine or in other parts of the body.
(49) In one example, spinal rods may be made adjustable according to the features disclosed herein to enable tuned adjustment of rod length at the time of implantation or subsequently as spinal healing and or adjustment takes place, such as for adjustment of rod length in connection with scoliosis treatment. In yet other examples, adjustable anchors may be employed in the reduction or fixation of other bones, such as bones of the hand, or of the foot or in other locations where adjustment of the length of an anchor or other fixation element is desirable. One such example would be incorporation of adjustability features disclosed herein in dual threaded headless screws or screws, rods or pins with other head and threading configurations that are used for interconnecting and reducing fractured bone fragments or adjacent bones. Such anchors adapted according to the instant disclosure would enable tuned adjustment of implant length to accommodate anatomical variations in a clinical subject and achieve optimized anchor placement.
(50) The invention is directed in various aspects to a system including assemblies and subassemblies, components including anchors and anchor components adapted for attachment to a bony structure of a clinical subject. In an exemplary embodiment wherein the use is in connection with fixation of the spine, wherein one, two or more such anchors in the form of screws are affixed to bones, for example, vertebral structures such as the pedicle, and each anchor is connected to a stabilizer such as a surgical rod that is inserted between the anchors. The anchors are novel in many respects owing to their modular nature and thus the options to provide the anchors in modular, sub-assembled and assembled forms provide a broad array of choices for the surgeon in devising the optimal surgical fixation plan.
(51) In use by a surgeon, installation of the inventive components of the exemplary bone anchor system for spinal fixation described above includes: selecting two or more bone anchor assemblies or subassemblies, including assemblies and subassemblies selected from pre-assembled and top and bottom loading forms, wherein at least one anchor assembly includes an length adjustable modular screw; selecting a stabilization element; using a suitable driver to drive each of two or more anchors or anchor subassemblies into fixed engagement with corresponding vertebrae, wherein at least one anchor or anchor subassembly includes or is adapted to engage with modular components that allow length adjustability, including translation along the vertical axis of the anchor, so as to enable selection of the anchor length by the surgeon; engaging a proximal portion of the modular adjustable anchor, such modular portion selected from a pre-assembled or modular screw head and engagement seat, to provide a means to introduce the stabilization element into engagement with the anchor; optionally incrementally adjusting the length of the anchor so as to achieve engagement of the stabilization element in the anchor; sliding the stabilization element into place within the anchor; introducing a fixation element to at least temporarily fix the stabilization element within the anchor; optionally, adjusting at least the vertical position of the anchor to optimize its height orientation relative to the stabilization element and adjacent anchors; tightening the fixation element to compress the stabilization element within the anchor assembly, thereby fixedly engaging the modular components of the anchor so as to lock the position of the anchor and also lock its engagement with the stabilization element. This process is repeated for each adjustable anchor in the system, and conventional methods are used with conventional anchors.
(52) It will be appreciated by one of skill in the art that the length adjustable modular screw described herein may be employed with components of a conventional spinal stabilization system, and may be used on a single vertebra, or traversing two or more vertebra, and may be used in conjunction with fusion or non-fusion treatment of the spine. Of course, in various examples, the anchors may be employed in isolation or in systems that include two or more anchors, connectors and stabilization elements, and the anchors may be deployed other than along the spinal axis. Thus, in other examples of use, two or more anchors may be used to secure one or more stabilization elements that extend either laterally or from an anterior to posterior aspect to traverse a vertebral body, or that wrap around one or more vertebral bodies, or combinations of these. And of course it will be appreciated that in some examples the assemblies and subassemblies, components, including anchors and anchor components, may be used in bones of the body other than the spine, and as such may be used individually, as a plurality, or in combination with other devices, and combinations of these.