US20100222819A1 - Integral Spring Junction - Google Patents
Integral Spring Junction Download PDFInfo
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- US20100222819A1 US20100222819A1 US12/776,913 US77691310A US2010222819A1 US 20100222819 A1 US20100222819 A1 US 20100222819A1 US 77691310 A US77691310 A US 77691310A US 2010222819 A1 US2010222819 A1 US 2010222819A1
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- Prior art keywords
- resilient element
- spring
- spring cap
- region
- bend
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
- A61B17/7002—Longitudinal elements, e.g. rods
- A61B17/7019—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other
- A61B17/7026—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other with a part that is flexible due to its form
- A61B17/7028—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other with a part that is flexible due to its form the flexible part being a coil spring
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
- A61B17/7002—Longitudinal elements, e.g. rods
- A61B17/7004—Longitudinal elements, e.g. rods with a cross-section which varies along its length
- A61B17/7007—Parts of the longitudinal elements, e.g. their ends, being specially adapted to fit around the screw or hook heads
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
- A61B17/7002—Longitudinal elements, e.g. rods
- A61B17/7004—Longitudinal elements, e.g. rods with a cross-section which varies along its length
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
- A61B17/7002—Longitudinal elements, e.g. rods
- A61B17/7011—Longitudinal element being non-straight, e.g. curved, angled or branched
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
- A61B17/7041—Screws or hooks combined with longitudinal elements which do not contact vertebrae with single longitudinal rod offset laterally from single row of screws or hooks
Abstract
Description
- The present application is a continuation application that claims priority benefit to a co-pending and commonly assigned non-provisional patent application entitled “Spring Junction and Assembly Methods for Spinal Device,” which was filed on Aug. 3, 2005, and assigned Ser. No. 11/196,102.
- 1. Technical Field
- The present disclosure relates to advantageous devices, systems and methods for spinal stabilization. More particularly, the present disclosure relates to devices, systems and methods for providing dynamic stabilization to the spine with systems/devices that include one or more enhanced spring junctions so as to provide clinically efficacious results.
- 2. Background Art
- Each year, over 200,000 patients undergo lumbar fusion surgery in the United States. While fusion is effective about seventy percent of the time, there are consequences even to these successful procedures, including a reduced range of motion and an increased load transfer to adjacent levels of the spine, which may accelerate degeneration at those levels. Further, a significant number of back-pain patients, estimated to exceed seven million in the U.S., simply endure chronic low-back pain, rather than risk procedures that may not be appropriate or effective in alleviating their symptoms.
- New treatment modalities, collectively called motion preservation devices, are currently being developed to address these limitations. Some promising therapies are in the form of nucleus, disc or facet replacements. Other motion preservation devices provide dynamic internal stabilization of the injured and/or degenerated spine, e.g., the Dynesys stabilization system (Zimmer, Inc.; Warsaw, Ind.) and the Graf Ligament. A major goal of this concept is the stabilization of the spine to prevent pain while preserving near normal spinal function.
- To provide dynamic internal spinal stabilization, motion preservation devices may advantageously include dynamic junctions that exhibit multiple degrees of freedom and commonly include active force-absorbing/force-generating structures. Such structures may include one or more resilient elements, e.g., torsion springs and/or coil springs, designed and deployed so as to contribute strength and flexibility to the overall device. While the flexibility afforded by such resilient elements is plainly critical to the effectiveness of the respective devices of which they faun a part, the elevated force levels associated with the use of such resilient elements can result in such resilient elements developing significant levels of internal stress. Depending on the magnitude and location thereof, internal stresses may pose the potential for stress-induced fatigue, material deformation and/or cracks. The FDA has promulgated rules (e.g., Title 21, Subchapter H, Part 888, Subpart D, Section 888.3070 regarding pedicle screw spinal systems) that, in relevant part, require manufacturers to demonstrate compliance with special controls, including but not limited to applicable mechanical testing standards geared toward high reliability and durability.
- With the foregoing in mind, those skilled in the art will understand that a need exists for devices, systems and methods for motion-preserving spinal stabilization devices and systems having reliable, durable constructions. In addition, a need exists for manufacturing processes and/or techniques that may be used to reliably and efficiently produce motion-preserving spinal stabilization devices and systems. These and other needs are satisfied by the disclosed devices and systems that include advantageous spring junctions, as well as the associate methods for manufacture/assembly thereof.
- According to the present disclosure, advantageous devices, systems and methods for spinal stabilization are provided. According to exemplary embodiments of the present disclosure, the disclosed devices, systems and methods include a spring junction that promotes reliable and efficacious spinal stabilization. The disclosed spring junction includes a structural member that is mounted or mountable with respect to a spine attachment fastener such as a pedicle screw, and a resilient element affixed to the structural member. The resilient element has an attachment region, along which the resilient element is affixed to the structural member, and an active region. The attachment region of the resilient element is physically separately disposed with respect to the active region thereof.
- According to exemplary embodiments of the present disclosure, the spring junction includes a weld region. A heat-affected zone of the resilient element and associated with the weld region is disposed adjacent the weld region, but is physically separately disposed with respect to the active region of the resilient element. The active region of the resilient element is generally subjected to cyclical stress, e.g., during in situ use of the disclosed spinal stabilization device. In exemplary embodiments, the weld region is produced via a welding process, such as electron-beam welding, and accordingly may be subjected to welding temperatures of about 1000° F. or higher. In addition, in exemplary embodiments of the present disclosure, the resilient element takes the form of a spring, e.g., a coil spring or helical spring, which extends into the weld region and which is mounted with respect to the structural member to form the spring junction.
- According to further exemplary embodiments of the present disclosure, the resilient element includes a bend region disposed between the weld region and an adjacent coil of the resilient element that extends along a helically-shaped path. The bend region is sized and shaped so as to initially bend away from the helically-shaped path before bending back toward the helically-shaped path and terminating at or in the weld region. In some such embodiments, the direction of the initial bend away from the helically-shaped path includes an axial component, but does not include a radial component. The bend region may further be sized and shaped so as to remain substantially peripherally aligned with such helically-shaped path when viewed in an axial direction with respect to the helically-shaped path. Of note, such spring junctions may be formed at opposite ends of the resilient element such that the resilient element/spring is mounted between spaced-apart structural members that are permitted to move relative to each other.
- According to further exemplary embodiments of the present disclosure, a rod is mounted with respect to (or integrally formed with) the structural member. The rod may be advantageously adapted to mount with respect to an upwardly-extending structure associated with a pedicle screw. The rod/pedicle screw may be mounted with respect to each other such that relative movement of the rod relative to the pedicle screw is permitted in at least one plane.
- In a still further embodiment, a method is disclosed for producing a spring junction in which a resilient element is welded to a structural member such that an active region of the resilient element is disposed physically separately with respect to the heat-affected zone associated with such welding. In some such embodiments, a further step is disclosed in which a resilient element is provided that defines an active region and a bend region, and wherein such welding results in the bend region being disposed between the active region and the heat-affected zone. Such a resilient element can include a coil extending along a helically-shaped path, and in which the bend region is configured so as to initially bend away from such helical path defined before bending back toward such helical path.
- In a still further embodiment, a combination is provided that includes a structural member having a first end, a second end opposite the first end, an aperture between the first end and the second end, and a notch formed in the second end. The combination also includes a resilient element having a bend region at an end thereof, the bend region terminating at a termination. The resilient element is secured to the first end of the structural member such that the bend region extends through the aperture and the termination is lodged in the notch. In some such embodiments, the resilient element is further affixed to the structural member via a weld formed with respect to the termination and the structural member at the notch. In other such embodiments, the termination is configured and dimensioned so as to extend at least partially in the direction of the first end of the structural member, and the bend region is configured and dimensioned such that the termination can be threaded through the aperture, and thereby rotated toward and into the notch. In some such cases the structural member includes a helical groove formed in the first end and terminating adjacent the aperture, and the resilient element includes an active region adjacent the bend region and spaced apart from the termination, and the active region includes a coil threaded along the helical groove to an extent of the aperture.
- The spring junction(s) of the present disclosure are typically employed as part of a spinal stabilization system that may advantageously include one or more of the following structural and/or functional attributes:
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- Exemplary embodiments of the spring junction (and associated spring/structural member subassembly) are capable of undergoing at least approximately 10,000,000 cycles of combined extension/contraction and bending (e.g., during mechanical testing);
- Implementation of the disclosed spring junctions have no substantial effect on the footprint of the dynamic stabilization devices in which they are incorporated, e.g., the resilient elements (e.g., springs) of such spinal stabilization devices do not extend radially inwardly or outwardly to a greater extent than the dynamic stabilization devices that do not include the disclosed spring junctions, thereby preserving compatibility with existing components and/or proven or preferred geometries;
- An outwardly/upwardly, then inwardly/downwardly extending bend region at each end of the resilient element, combined with a notch on the external end of each spring cap plate provides a snap-fit system which positively locates the ends of the resilient element within their respective notches during pre-welding assembly, and presents a convenient face for purposes of electronic-beam welding without undue risk of annealing and/or other types of damage to the active region of the resilient element.
- Advantageous spine stabilization devices, systems and methods may incorporate one or more of the foregoing structural and/or functional attributes. Thus, it is contemplated that a system, device and/or method may utilize only one of the advantageous structures/functions set forth above, a plurality of the advantageous structures/functions described herein, or all of the foregoing structures/functions, without departing from the spirit or scope of the present disclosure. Stated differently, each of the structures and functions described herein is believed to offer benefits, e.g., clinical advantages to clinicians and/or patients, whether used alone or in combination with others of the disclosed structures/functions.
- Additional advantageous features and functions associated with the devices, systems and methods of the present disclosure will be apparent to persons skilled in the art from the detailed description which follows, particularly when read in conjunction with the figures appended hereto. Such additional features and functions, including the structural and mechanistic characteristics associated therewith, are expressly encompassed within the scope of the present invention.
- To assist those of ordinary skill in the art in making and using the disclosed devices, systems and methods for achieving enhanced reliability, dependability, and/or durability, e.g., in a dynamic spinal stabilization device, reference is made to the appended figures wherein:
-
FIG. 1 is a perspective exploded assembly view of a spinal stabilization device/system, according to the present disclosure; -
FIG. 2 is an exploded assembly view of a spinal stabilization device/system, including pedicle screws and associated mounting structures, in accordance with an embodiment of the present disclosure; -
FIG. 3 is an unexploded assembly view of the exemplary spinal stabilization device/system ofFIG. 2 ; -
FIGS. 4 , 5 and 6 are interior end, exterior end, and cross-sectional views of a structural member associated with the exemplary spinal stabilization device/system ofFIGS. 2-3 ; -
FIGS. 7 , 8 and 9 are interior end, exterior end, and cross sectional views of another structural member associated with exemplary spinal stabilization device/system ofFIGS. 2-3 ; -
FIG. 10 is a side view of a resilient element that may be employed in forming one or more spring junctions according to the present disclosure; -
FIG. 11 is a side assembly view of the exemplary spinal stabilization device/system of -
FIGS. 2-3 illustrating assembly of the components ofFIGS. 4-9 ; -
FIG. 12 is a perspective detail view of the interface between the structural member ofFIGS. 7-9 and the resilient element ofFIG. 10 ; -
FIG. 13 is a top view of the interface between the structural member ofFIGS. 7-9 and the resilient element ofFIG. 10 ; -
FIG. 14 is a sectional view of the interface between the structural member ofFIGS. 7-9 and the resilient element ofFIG. 10 taken along the line 14-14 ofFIG. 13 ; and -
FIGS. 15 and 16 illustrate various exemplary types and ranges of motion associated with exemplary spinal stabilization devices/assemblies of the present disclosure. - The present disclosure provides advantageous devices, systems and methods for improving the reliability, dependability and/or durability of spinal stabilization systems. More particularly, the present disclosure provides advantageous devices, systems and methods for mechanically mounting resilient elements (e.g., torsion springs and/or coil springs) to, and/or for coupling resilient elements between, structural members (e.g., plates, caps, flanges, rods, and/or bars) associated with dynamic spinal stabilization systems. The mounting and/or coupling methods/techniques of the present disclosure provide enhanced reliability, dependability and/or durability without significantly increasing material weight or volume requirements and without compromising the important functions of the dynamic spinal stabilization devices/systems of which they form a part.
- The exemplary embodiments disclosed herein are illustrative of the advantageous spinal stabilization devices/systems and surgical implants of the present disclosure, and of methods/techniques for implementation thereof. It should be understood, however, that the disclosed embodiments are merely exemplary of the present invention, which may be embodied in various forms. Therefore, the details disclosed herein with reference to exemplary dynamic spinal stabilization systems and associated methods/techniques of assembly and use are not to be interpreted as limiting, but merely as the basis for teaching one skilled in the art how to make and use the advantageous dynamic spinal stabilization systems and alternative surgical implants of the present disclosure.
- With reference to
FIG. 1 , components of adynamic stabilization element 10 disclosed in commonly assigned U.S. Non-Provisional patent application Ser. No. 11/027,270, filed Dec. 31, 2004 (hereinafter “the '270 Application”), are shown in an exploded view. The disclosure of the '270 Application is hereby incorporated herein by reference in its entirety. As shown inFIG. 1 , thedynamic stabilization element 10 includes two structural elements in the form of aspring cap 12 and aspring cap 14, and two resilient elements in the form of aninner spring 16 and anouter spring 18. Thespring cap 12 is affixed to anattachment member 20 that is configured to be coupled to the head of a pedicle screw (not shown) via a dynamic joint (not shown). Thespring cap 14 is affixed to arod 22 that is configured to be attached to another attachment member (not shown) that is in turn coupled to the head of another pedicle screw (not shown) via another dynamic joint (not shown). Thedynamic stabilization element 10 permits relative axial/longitudinal motion, as well as angular/rotational motion, of therod 20 relative to theattachment member 20, as part of a larger spinal stabilization system (shown only in relevant part). - The
spring cap 12 includes aninterior end 24, anexterior end 26 opposite the interior end, apost 28 axially positioned on theinterior end 24, anannular channel 30 formed in theinterior end 24 around thepost 28, a helically-shapedgroove 32 formed in theinterior end 24 around theannular channel 30, and anaperture 34 passing through thespring cap 12 between the interior and exterior ends 24, 26 thereof at anend 36 of the helically-shapedgroove 32. Thespring cap 14 includes aninterior end 38, anexterior end 40 opposite theinterior end 38, apost 42 axially positioned on theinterior end 38 around thepost 42, a helically-shapedgroove 46 formed in theinterior end 38 around theannular channel 44, and anaperture 48 passing through thespring cap 14 between the interior and exterior ends 38, 40 thereof at anend 50 of the helically-shapedgroove 46. - The
inner spring 16 consists ofcoils 52 sharing a common diameter and arranged sequentially about a common axis between a coil termination 54 (obscured) at anend 56 of theinner spring 16 and acoil termination 58 at anotherend 60 thereof opposite theend 56. Theouter spring 18 consists ofcoils 62 sharing a common diameter and arranged sequentially about a common axis between a coil termination 64 (obscured) at anend 66 of theouter spring 18 and acoil termination 68 at anotherend 70 thereof opposite theend 66. - In the assembled state of the
dynamic stabilization element 10, theinner spring 16 is positioned within theouter spring 18. Thecoil 52 at theend 56 of theinner spring 16 is positioned on or around thepost 28 of thespring cap 12, and against theinterior end 24 of thespring cap 12 so as to occupy (at least in part) theannular channel 30 formed therein. Thecoil 52 at theend 60 of theinner spring 16 is positioned on or around thepost 42 of thespring cap 14 and against theinterior end 38 of thespring cap 14 so as to occupy (at least in part) theannular channel 44 formed therein. In this way, theinner spring 16 is effectively captured between thespring cap 12 and thespring cap 14 and effectively floats relative to the opposingposts coil 62 at theend 66 of theouter spring 18 is threaded into theinterior end 24 of thespring cap 12 along the helically-shapedgroove 32 at least until thecoil termination 64 reaches theaperture 34 of thespring cap 12. Theouter spring 18 is fixed with respect to thespring cap 12, e.g., by welding, and may be trimmed so as to be flush relative to an edge formed at the interface between theaperture 34 and theexterior end 26 of thespring cap 12. Thecoil 62 at theend 70 of theouter spring 18 is threaded into theinterior end 38 of thespring cap 14 along the helically-shapedgroove 46 at least until thecoil termination 68 reaches theaperture 48 of thespring cap 14. Theouter spring 18 is fixed with respect to thespring cap 14, e.g., by welding, and may be trimmed so as to be flush relative to an edge formed at the interface between theaperture 48 and theexterior end 40 of thespring cap 14. - As described in the '270 Application, the
outer spring 18 is typically shorter than theinner spring 16, such that as thespring cap 12 and thespring cap 14 are brought toward each other (i.e., to permit theouter spring 18 to be mounted on both), theinner spring 16 is placed in compression. The degree to which theinner spring 16 is compressed is generally dependent on the difference in length as between the inner andouter springs inner spring 16 may be controlled and/or adjusted in part through selection of the relative lengths of the inner andouter springs inner spring 16, the mounting of theouter spring 18 with respect to the spring caps 12, 14 includes placing theouter spring 18 in tension. The overall preload of thedynamic stabilization element 10 corresponds to equal and opposite forces experienced by and/or contained within the inner andouter springs - The
inner spring 16 reaches its free length (i.e., non compressed state) at or about the point at which a patient's movement exceeds a “neutral zone” (as described more completely in the '270 Application). Beyond this point, theinner spring 16 is free floating (e.g., on the opposingposts 28, 42), while theouter spring 18, already in tension, extends in length even further. - In the overall design of the disclosed spinal stabilization system, optimization of the attachment between the
outer spring 18 and thespring cap 14 is desirable. In experimental studies associated with spinal stabilization devices of the type disclosed herein, it has been noted that direct welding of theouter spring 18 and thespring cap 14 may not provide an optimal means of attachment. While not intending to be bound by theory, it is believed that a “heat-affected” zone may be created in thecoil 62 at theend 70 of theouter spring 18 as a result of the process of welding theouter spring 18 to thespring cap 14. More particularly, such heat-affected zone is believed to arise as a result of an annealing effect brought about by the migration of excess heat arising from an electronic-beam welding process. In accordance with such electronic beam or E-beam welding processes, elevated temperatures in a range of approximately 1000° F. or higher are used to affix theouter spring 18 to thespring cap 14 by essentially melting such components together. The heat-affected zone so produced can be at least 0.005″-0.030″ in axial length, and is located immediately adjacent the weld formed at theend 70 of theouter spring 18, and along the active region of theouter spring 18. (As used herein in reference to a spring or resilient element, the term “active region” or “active portion” refers to a region, portion, or part of the spring or resilient element which, during normal in-situ use and/or representative mechanical testing of the spring or resilient element, actively contributes to the characteristic stiffness of the spring or resilient element, and/or actively participates in the axial travel and/or lateral bending thereof.) The heat-affected zone can include a soft or weak point on thecoil 62 at which a Rockwell hardness of the material of theouter spring 18, ordinarily falling within a range of from approximately 46 to approximately 54, dips sharply; e.g., to a value in a range of from approximately 20 to approximately 24. - According to the present disclosure, geometric/structural modifications to the
outer spring 18 and thespring cap 14 have been found to advantageously enhance the reliability and durability ofdynamic stabilization element 10. Exemplary embodiments of the advantageous geometric/structural modifications to theouter spring 18 and thespring cap 14 are described hereinbelow with reference toFIGS. 2-14 , as is a beneficial cooling/supercooling step involving the modified outer spring and the modified spring caps associated therewith. As a result of these geometric/structural modifications, and/or of the cooling/supercooling step, a durability standard of 10,000,000+failure-free cycles has been achieved with apparatus in which an outer spring has been welded to its associated spring caps to form a dynamic stabilization device as described herein. - According to exemplary embodiments of the present disclosure, the geometric/structural modifications include the creation of a substantial physical separation of the active portion of the outer spring from the heat-affected zone associated with the E-beam welding process, and/or from the actual site of the weld formed between the attached components. As a result of this separation, to the extent that any region of the outer spring becomes significantly annealed, and/or is brought to a significantly lowered Rockwell hardness value as a result of E-beam welding, the amount of cyclic stress to which that softened or annealed portion is exposed is substantially reduced and/or brought to such a low level that the respective junctions between the outer spring and its associated spring caps can exhibit very high levels of reliability/durability.
- With reference to
FIGS. 2 and 3 , a dynamicspinal stabilization system 100 is shown in accordance with an exemplary embodiment of the present disclosure. Referring toFIG. 2 , thespinal stabilization system 100 includesattachment members spherical elements screws attachment member 102 is configured to receive the ball/spherical element 110. The ball/spherical element 110 then receives the head of thepedicle screw 106 such that a global/dynamic joint is formed between theattachment member 102 and the head of the pedicle screw 106 (see alsoFIG. 3 ). Theset screw 114 is then inserted into the head of the pedicle screw 106 (see alsoFIG. 3 ), thereby securing the head of thepedicle screw 106 within the ball/spherical element 110. Theattachment member 104 is configured to receive the ball/spherical element 112. The ball/spherical element 112 then receives the head of thepedicle screw 108 such that a global/dynamic joint is formed between theattachment member 104 and the head of the pedicle screw 108 (see alsoFIG. 3 ). Theset screw 116 is then inserted into the head of the pedicle screw 108 (see alsoFIG. 3 ), thereby securing the head of thepedicle screw 108 within the ball/spherical element 112. - The
spinal stabilization system 100 also includes arod 118. The rod is configured to be inserted into theattachment member 104, which includes atransverse aperture 120 to accommodate therod 118, and aset screw 122 to secure therod 118 at a desired position within the transverse aperture 120 (see alsoFIG. 3 , in which ahex driver 124 is shown turning theset screw 122 against the rod 118). - The
spinal stabilization system 100 further includes adynamic stabilization element 126 between therod 118 and theattachment member 102. Thedynamic stabilization element 126 includesstructural members resilient element 132, an outerresilient element 134, asheath member 136, and two end clamps 138. As shown inFIG. 3 , the inner resilient element 132 (obscured) and outer resilient element 134 (partially obscured) are positioned within thesheath member 136, and anend clamp 138 secures thesheath member 136 to each of thestructural members resilient elements FIG. 2 , the innerresilient element 132 is constructed and functions in manners substantially similar to those of theinner spring 16 described hereinabove with reference to thedynamic stabilization element 10. The innerresilient element 132 is also deployed and employed in thedynamic stabilization element 126 in manners substantially similar to those in which theinner spring 16 is deployed and employed in thedynamic stabilization element 10 described hereinabove. - The following components of the
dynamic stabilization element 126 will now be described in greater detail: the structural member 128 (with reference toFIGS. 4-6 ), the structural member 130 (with reference toFIGS. 7-9 ), and the outer resilient element 134 (with reference toFIG. 10 ). Next, the manner in which thestructural members resilient element 134 are assembled will be discussed (with particular reference toFIGS. 11-14 ). Then, the functions of thedynamic stabilization element 126 will be discussed, followed by a discussion of the characteristic advantages of thedynamic stabilization element 126. - Referring now to
FIGS. 4-6 , thestructural member 128 is affixed to (e.g., is of unitary construction with) the attachment member 102 (the ball/spherical element 110 is also shown within the attachment member 102) and takes the form of a plate having multiple features permitting thestructural member 128 to function in the manner of an end cap or spring cap with respect to the inner and outerresilient elements 132, 134 (FIG. 2 ). Thestructural member 128 includes aninterior end 140, anexterior end 142 opposite theinterior end 140, apost 143 axially positioned on theinterior end 140, anannular channel 144 formed in theinterior end 140 around thepost 143, a helically-shapedgroove 146 formed in theinterior end 140 around theannular channel 144, anaperture 148 passing through thestructural member 128 between the interior and exterior ends 140, 142 thereof at anend 150 of the helically-shapedgroove 146, ashort groove 152 formed in theexterior end 142 adjacent theaperture 148, and a notch 154 formed in theexterior end 142 at anend 156 of theshort groove 152. The structure and function of thestructural member 128 will be described in greater detail hereinafter. - Referring now to
FIGS. 7-9 , thestructural member 130 is affixed to (e.g., is of unitary construction with) the rod 118 (which is positioned off-axis or off-center with respect to the structural member 130), and takes the form of a plate having multiple features permitting thestructural member 130 to function in the manner of an end cap or spring cap with respect to the inner and outerresilient elements 132, 134 (FIG. 2 ). Thestructural member 130 includes aninterior end 158, anexterior end 160 opposite theinterior end 158, apost 162 axially positioned on theinterior end 158, anannular channel 164 formed in theinterior end 158 around thepost 162, a helically-shapedgroove 166 formed in theinterior end 158 around theannular channel 164, anaperture 168 passing through thestructural member 130 between the interior and exterior ends 158, 160 thereof at anend 170 of the helically-shapedgroove 166, ashort groove 172 formed in theexterior end 160 adjacent theaperture 168, and anotch 174 formed in theexterior end 160 at anend 176 of theshort groove 172. The structure and function of thestructural member 130 will be described in greater detail hereinafter. - Referring now to
FIG. 10 , the outerresilient element 134 consists ofcoils 178 sharing a common diameter and arranged sequentially about a common axis between acoil termination 180 at anend 182 of the outerresilient element 134 and acoil termination 184 at anotherend 186 thereof opposite theend 182. Extending from thecoil termination 180, and substantially continuous therewith, is abend region 188 of the outerresilient element 134. Extending from thecoil termination 184, and substantially continuous therewith, is abend region 190 of the outerresilient element 134. - The
bend regions resilient element 134 extend peripherally from therespective coil terminations FIG. 13 ) from eitherend resilient element 134, are defined by respective single radii that extend from the common axis of thecoils 178 of the outerresilient element 134 and that have extents approximately half that of the common diameter of thecoils 178. As a result, thebend regions resilient element 134 remain within the same peripheral outline defined by thecoils 178 of the outerresilient element 134. When viewed from the side, however, as inFIG. 10 , thebend regions resilient element 134 are seen to depart from the helical path defined by thecoils 178. - More particularly, the
bend region 188, when viewed from the side as inFIG. 10 , is seen to include a curve or bend in the path of extension of thebend region 188, according to which the material of the outer resilient element 134: (1) initially curves away from theadjacent coil 178 at thecoil termination 180; (2) reaches an apex 192 representing a point of maximum departure from theadjacent coil 178; (3) curves therefrom back toward theadjacent coil 178; and (4) terminates at abend region termination 194 without fully returning to the helical path defined by thecoils 178. Also, thebend region 190, when viewed from the side as inFIG. 10 , is seen to include a curve or bend in the path of extension of thebend region 190, according to which the material of the outer resilient element 134: (1) initially curves away from theadjacent coil 178 at thecoil termination 184; (2) reaches an apex 196 representing a point of maximum departure from theadjacent coil 178; (3) curves therefrom back toward theadjacent coil 178; and (4) terminates at abend region termination 198 without fully returning to the helical path defined by thecoils 178. The structure and function of the outerresilient element 134 will be described in greater detail hereinafter. - In the assembled state of the
dynamic stabilization element 126 shown inFIG. 11 , the inner resilient element 132 (obscured, seeFIG. 2 ) is positioned within the outerresilient element 134, between the respective posts 143 (FIG. 4 ), 162 (FIG. 7 ), and within the respective annular channels 146 (FIG. 4 ), 164 (FIG. 7 ) of thestructural elements bend region 190 and thecoil 178 at the end 186 (FIG. 10 ) of the outerresilient element 134 are threaded into the interior end 140 (FIG. 6 ) of thestructural element 128 until thebend region 190 has substantially passed into or through theaperture 148 of thestructural element 128 and thebend region termination 198 has been caused to drop or snap into place within the notch 154 (FIG. 5 ) formed in theexterior end 142 of thestructural element 128. Thebend region 188 and thecoil 178 at the end 182 (FIG. 10 ) of the outerresilient element 134 are threaded into the interior end 158 (FIG. 9 ) of thestructural element 130 until thebend region 188 has substantially passed into or through theaperture 168 of thestructural element 130 and the bend region termination 194 (obscured, seeFIG. 10 ) has been caused to drop or snap into place within the notch 174 (FIG. 8 ) formed in theexterior end 160 of thestructural element 130. - Referring now to
FIG. 12 , the interface or spring junction between the outerresilient element 134 and thestructural element 130 is shown in greater detail. As indicated above, thebend region 188 largely or completely extends into or through theaperture 168 formed in thestructural element 130, and thebend region termination 194 is lodged within thenotch 174 formed in theexterior end 160 of thestructural element 130. More particularly, aportion 200 of thebend region 188 of the outerresilient element 134 near thecoil termination 180 is lodged within the short groove 172 (FIG. 9 ) formed in theexterior end 160 of thestructural element 130, aportion 202 of thebend region 188 associated with the apex 192 thereof is lodged within theshort groove 172 and in longitudinal contact with theexterior end 160 of thestructural element 130, and aportion 204 of thebend region 188 associated with thebend region termination 194 is lodged within theshort groove 172 to an extent of thenotch 174. The outerresilient element 134 is welded to theexterior end 160 of thestructural element 130 in the vicinity of thenotch 174, e.g., via electronic-beam welding along an extent of theportion 204 of thebend region 188 that is lodged within thenotch 174. The outerresilient element 134 can be placed in a state of full compression in advance of such welding so as to ensure that after such welding, theportion 202 of thebend region 188 associated with the apex 192 thereof is biased in favor of continuous longitudinal contact with theexterior end 160 of thestructural element 130 during normal in situ use of, and/or during representative mechanical testing of, thedynamic stabilization element 126. - Though not shown in
FIG. 12 , a portion (not separately shown) of the bend region 190 (FIG. 10 ) near the coil termination 184 (FIG. 10 ) is similarly lodged within the short groove 152 (FIG. 5 ) formed in the exterior end 142 (FIG. 6 ) of thestructural element 128, a portion (not separately shown) of the bend region 190 (FIG. 10 ) associated with the apex 196 (FIG. 10 ) thereof is lodged within theshort groove 152 and in longitudinal contact with theexterior end 142 of thestructural element 128, and a portion (not separately shown) of thebend region 190 associated with thebend region termination 198 is lodged within theshort groove 152 to an extent of the notch 154. The outerresilient element 134 is welded to theexterior end 142 of thestructural element 128 in the vicinity of the notch 154, e.g., via electronic-beam welding along an extent of the portion (not separately shown) of thebend region 190 that is lodged within the notch 154 (FIG. 5 ). The outerresilient element 134 can be placed in a state of full compression in advance of such welding for the same reasons and to achieve a similar biasing effect in thebend region 190 as is described above with reference to thebend region 188. - A cooling/supercooling step may be advantageously undertaken in advance of welding such as is described immediately hereinabove. In accordance with such a step, the outer
resilient element 134 and thestructural members resilient element 134 is welded to thestructural elements resilient element 134 and thestructural members - Referring to
FIGS. 13 and 14 , the above-described welding process produces aweld region 206 incorporating portions of theexterior end 160 of thestructural element 130 at theend 176 of theshort groove 172 in the vicinity of thenotch 174, as well as portions of thebend termination 194 of thebend region 188 of the outerresilient element 134. Theportion 204 of thebend region 188 is long enough, and the corresponding portion of theshort groove 172 is long enough, such thatweld region 206 terminates at apoint 208 along the extent of thebend region 188 well short of the apex 192 thereof Accordingly, theweld region 206 also terminates well short of acorresponding apex 210 of theshort groove 172 against which theportion 202 of thebend region 188 is biased. To the extent theportion 204 of thebend region 188 includes a heat-affectedzone 212 associated with the process used to affix the outerresilient element 134 to thestructural element 130,such region 212 also terminates at apoint 214 along the extent of thebend region 188 well short of the apex 192 thereof, as well as well short of the apex 210 of theshort groove 172. Theportion 202 of thebend region 188 and theexterior end 160 of thestructural member 130 are in intimate and continuous longitudinal contact along theshort groove 172 at least from the apex 210 thereof and for anextent 216 extending toward theaperture 168. Beyond theextent 216, theshort groove 172 tends to depart from intimate contact from theportion 200 of thebend region 188 for anextent 218 extending fully to theaperture 168. The significance and functional benefits of such structure and/or such assembly arrangement between thebend region 188 of the outerresilient element 134 and theexterior end 160 of thestructural element 130 will be explained more fully hereinafter. - Turning now to
FIGS. 15 and 16 , in operation, thedynamic stabilization element 126 of the spinal stabilization system 100 (FIG. 2 ) permits relative rotational motion, as well as relative translational motion, as between therod 118 and theattachment member 102, and/or as between therod 118 and the ball/spherical element 110, while providing enhanced spinal support for the patient, e.g., in the “neutral zone” described more fully in the ‘270 Application. More particularly, thedynamic stabilization element 126 as a unit, and/or the outerresilient element 134 by itself, supports either and/or both of spinal extension and spinal flexion. Referring toFIG. 15 , thedynamic stabilization element 126 is shown as it would appear while supporting spinal extension, wherein anextent 220 of, for example, less than 5° of relative rotation as between therod 118 and the ball/spherical element 110 is produced. Such spinal extension can also produce approximately one millimeter of travel in theresilient element 134 relative to the initial position thereof (i.e., wherein theresilient element 134 is preloaded in tension so as to be slightly extended), such that theresilient element 134 may now actually assume a fully compressed state. Referring toFIG. 16 , thedynamic stabilization element 126 is shown as it would appear while supporting spinal flexion, wherein anextent 222 of, for example, greater than 10° of relative rotation as between therod 118 and the ball/spherical element 110 is produced. Such spinal flexion can produce approximately one and one-half millimeters of travel (i.e., additional extension) in theresilient element 134 relative to the initial position thereof. - Referring again to
FIG. 14 , the outerresilient element 134 is shown in a state of full compression against theinterior end 158 of thestructural element 130. As discussed above, when the outerresilient element 134 is in this condition, thebend region 188 of the outerresilient element 134 is biased toward contact with theexterior end 160 of thestructural element 130. To the extent the outerresilient element 134 is caused to expand from its fully compressed state, this bias is not relaxed. Rather, this bias is only reinforced by such torsional and/or bending forces as may tend to urge theportion 200 of thebend region 188 further through theaperture 168 in the direction of theinterior end 158. (For example, depending on the particular axial and/or lateral forces imposed upon the outerresilient element 134, theportion 200 of thebend region 188 can tend to bend and/or twist close to/closer to the angled exterior surface associated with theextent 218 of the short groove 172). At the same time, theportion 202 of thebend region 188 remains lodged in theshort groove 172, where it remains in intimate contact with theexterior end 160 ofstructural element 130, and as such is not capable of being deflected any further in the direction of theinterior end 158 by such axial and/or lateral forces. Accordingly, such axial and/or lateral forces are prevented from directly acting upon either of theweld region 206 or the heat-affectedzone 212 of the outerresilient element 134. More particularly, the consistent, continuous longitudinal contact between theportion 202 of thebend region 188 and theexterior end 160 of thestructural element 130 along theshort groove 172 thereof acts as a permanent ‘fulcrum’, beyond which the torsional and/or bending forces arising in theportion 200 of thebend region 188 are not necessarily transmitted as such to theweld region 206 or the heat-affectedzone 212, at least not in a form capable of producing fatigue-inducing stress in such region/zone. In other words, the active region of the outerresilient element 134 extends no further toward theweld region 206 or the heat-affectedzone 212 than the apex 192 of thebend region 188. Since such regions are physically separated from the apex 192 via corresponding structural features of the outerresilient element 134 and thestructural member 130, and/or via the manner in which the same are affixed to each other, such forces as are applied to theweld region 206 and the heat-affectedzone 212 during in situ use or representative mechanical testing will have been channeled into a cantilevered arrangement. In accordance with such cantilevered arrangement, a fulcrum (e.g., theextent 216 within the short groove 172) provides theweld region 206 with significant mechanical advantage by which to resist such forces without experiencing undue internal stress. - The
dynamic stabilization element 126 associated with thespinal stabilization system 100 described hereinabove with regard toFIGS. 2-14 provides numerous advantages in comparison to other spinal stabilization systems associated therewith. Referring again toFIGS. 11 and 14 , and while not necessarily intending to be bound by theory, improved reliability and durability is achieved with the disclosed dynamic stabilization element based at least in part on the fact that the heat-affected zone associated with the process of joining the outerresilient element 134 to thestructural elements resilient element 134, and is therefore isolated from the cyclical stress associated with repeated extension/contraction and/or bending during normal use and/or representative mechanical testing. More particularly, theportion 202 of thebend region 188 of the outerresilient element 134 fully separates theportion 202 of the outerresilient element 134 from theportion 204 thereof at which the outerresilient element 134 is welded to thestructural member 130. In like measure, and in a similar fashion, the welded and threaded connection between the outerresilient element 134 and thestructural member 128 provides similar advantages. Typically, due to the particular structures and assembly methods described above, the heat-affected zone in exemplary embodiments of the present disclosure is observed to extend axially approximately 005″-0.030″ from the weld region along the material of the outerresilient element 134, and the active region of the outerresilient element 134 extends no farther in the direction of the welded interfaces than therespective apexes bend regions bend regions resilient element 134 is substantially completely shielded from any material degradation that may result from the assembly step, e.g., via electronic-beam welding. In other words, to the extent the use of E-beam welding reduces the Rockwell hardness of a portion or portions of the outerresilient element 134, such portion or portions are substantially completely shielded from fatigue-producing levels of cyclic stress. - The
dynamic stabilization element 126 associated with thespinal stabilization system 100 described hereinabove with regard toFIGS. 2-14 can be the subject of numerous modifications and variations while still exhibiting the above-discussed advantages over other dynamic junctions for spinal stabilization systems. For example, therod 118 can be repositioned to an axial position with respect to thestructural member 130. Thebend region termination 194 can be affixed to thestructural member 130 by other welding processes than E-beam welding, and/or by one or more non-welding means of attachment, such as by clamping or the use of mechanical fasteners appropriate for use in conjunction with small gage springs, by an adhesive-based process, or via the use of a single mold to form the two components together as a single piece. To the extent such attachment schemes result in respective attachment regions along which thebend region termination 194 is affixed to the structural member, such attachment regions are similarly disposed physically separately relative to the respective active region of the outer resilient element 134 s (whether or not heat-affected zones are present), and are thereby similarly shielded from the types and levels of cyclical stress known to produce fatigue failure. The outerresilient element 134 need not necessarily be configured in the manner of a coil spring, but may instead take the form of one or more other types of resilient elements, such as a leaf spring, a torsion spring or bar, etc. Additionally, the outerresilient element 134 may be employed in a dynamic junction that does not also include the innerresilient element 132. Many other variations and/or modifications are possible. - Although the present disclosure has been disclosed with reference to exemplary embodiments and implementations thereof, those skilled in the art will appreciate that the present disclosure is susceptible to various modifications, refinements and/or implementations without departing from the spirit or scope of the present invention. In fact, it is contemplated the disclosed connection structure may be employed in a variety of environments and clinical settings without departing from the spirit or scope of the present invention. Accordingly, while exemplary embodiments of the present disclosure have been shown and described, it will be understood that there is no intent to limit the invention by such disclosure, but rather, the present invention is intended to cover and encompass all modifications and alternate constructions falling within the spirit and scope hereof.
Claims (13)
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US12/776,913 Abandoned US20100222819A1 (en) | 2005-08-03 | 2010-05-10 | Integral Spring Junction |
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