Source: http://www.google.com/patents/US7682375?dq=7069184
Timestamp: 2013-12-19 13:22:10
Document Index: 744748382

Matched Legal Cases: ['Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 2003228960', 'Application No. 2004228019', 'Application No. 10', 'Application No. 10', 'Application No. 2', 'Application No. 200480014833', 'Application No. 04758814']

Patent US7682375 - Dynamic fixation device and method of use - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsA dynamic fixation device is provided that allows the vertebrae to which it is attached to move in flexion within the normal physiological limits of motion, while also providing structural support that limits the amount of translation motion beyond normal physiological limits. The present invention includes...http://www.google.com/patents/US7682375?utm_source=gb-gplus-sharePatent US7682375 - Dynamic fixation device and method of useAdvanced Patent SearchPublication numberUS7682375 B2Publication typeGrantApplication numberUS 10/435,330Publication dateMar 23, 2010Filing dateMay 8, 2003Priority dateMay 8, 2002Also published asCA2484923A1, CA2484923C, EP1585427A2, EP1585427A4, EP1585427B1, EP2457528A1, EP2457529A1, US8486111, US8585739, US20040002708, US20070016193, US20100160969, US20100174318, US20100179596, WO2003094699A2, WO2003094699A3Publication number10435330, 435330, US 7682375 B2, US 7682375B2, US-B2-7682375, US7682375 B2, US7682375B2InventorsStephen RitlandOriginal AssigneeStephen RitlandExport CitationBiBTeX, EndNote, RefManPatent Citations (103), Non-Patent Citations (78), Referenced by (3), Classifications (15), Legal Events (1) External Links: USPTO, USPTO Assignment, EspacenetDynamic fixation device and method of useUS 7682375 B2Abstract A dynamic fixation device is provided that allows the vertebrae to which it is attached to move in flexion within the normal physiological limits of motion, while also providing structural support that limits the amount of translation motion beyond normal physiological limits. The present invention includes a flexible portion and two ends that are adapted for connection to pedicle screws. In at least one embodiment of the present invention, the normal axis of rotation of the vertebrae is substantially duplicated by the dynamic fixation device. The flexible portion of the dynamic fixation device can include a geometric shape and/or a hinge portion.
1. An implantable dynamic fixation device for flexibly linking a first vertebra to a second vertebra of a spine, comprising:
first and second rod members;
first and second pedicle screws, the first rod member being interconnectable to the first vertebra by the first pedicle screw and the second rod member being interconnectable to the second vertebra by the second pedicle screw;
at least one link adapted for having a substantially anterior-posterior alignment relative to the spine when implanted, with a first end pivotally interconnected to said first rod member and a second end pivotally interconnected to said second rod member, wherein said first end of said at least one link is located anterior to the second end of the at least one link when implanted;
a second link pivotally interconnecting said first rod member to said second rod member, wherein said second link is spaced apart from said at least one link along a length of at least one of said first rod member and said second rod member;
wherein said first rod member can be rotated relative to said second rod member upon flexion of the first vertebra relative to the second vertebra when implanted;
(a) one of said first and second rod members; and
(b) said link;
comprises plastic.
2. An implantable dynamic fixation device for flexibly linking a first vertebra to a second vertebra of a spine, comprising:
a first transverse member adapted for having a substantially anterior-posterior alignment relative to the spine when implanted, the first transverse member having a first end pivotally interconnected to said first rod member and a second end pivotally interconnected to said second rod member, wherein said first end of said first transverse member is located sagittally anterior of the second end of the first transverse member when implanted; and
a second transverse member pivotally interconnecting said first rod member to said second rod member;
wherein said first rod member can be rotated relative to said second rod member upon flexion of the first vertebra relative to the second vertebra when implanted; and
wherein said second transverse member is spaced apart from said first transverse member along a length of at least one of said first rod member and said second rod member.
3. The dynamic fixation device as claimed in claim 2, wherein at least one of:
(b) one of said first and second transverse members;
4. An implantable dynamic fixation device for rotatably securing a first vertebra to a second vertebra of a spine, comprising:
(a) at least first and second pedicle screws and first and second connectors, wherein a center of the first connector and a center of the second connector define a longitudinal axis of the device when implanted;
(b) at least first and second rod arms, said first rod arm interconnectable to said first pedicle screw by said first connector, said second rod arm interconnectable to said second pedicle screw by said second connector; and
(c) at least one additional arm connected to said first rod arm at a point anterior to the longitudinal axis when implanted, and connected to said second rod arm at a point posterior to the longitudinal axis when implanted, said additional arm adapted for having a substantially anterior-posterior alignment relative to the spine when implanted, with a first end of the additional arm associated with said first rod arm and a second end of the additional arm associated with said second rod arm, wherein upon implantation said first end of said additional arm is located anterior to said second end of the additional arm;
wherein said first rod arm can be rotated relative to said second rod arm upon flexion of the first vertebra relative to the second vertebra when implanted.
5. The dynamic fixation device as claimed in claim 4, further comprising a second additional arm pivotally interconnecting said first and second rod arms.
6. The dynamic fixation device as claimed in claim 5, wherein said second additional arm is spaced apart from said at least one additional arm along a length of at least one of said first and second rod arms.
7. The dynamic fixation device as claimed in claim 4, wherein at least one of:
(a) one of said first and second rod arms; and
(b) said additional arm;
8. An implantable device for rotatably securing a first vertebra to a second vertebra of a spine, the device being interconnectable to the first vertebra and to the second vertebra, the device comprising:
first and second pedicle screws adapted for connecting to the first and second vertebrae, respectively;
a first member connectable to the first pedicle screw by a first connector and a second member connectable to the second pedicle screw by a second connector, said first and second members coplanar and configured for implanting in a plane substantially parallel to a sagittal plane defined by the spine, wherein a center of the first connector and a center of the second connector define a longitudinal axis of the device when implanted; and
at least one rotatable arm adapted for transverse alignment relative to the spine when implanted, said arm connected to said first member at a location anterior of the longitudinal axis and to said second member at a location posterior of the longitudinal axis, wherein a first end of said arm is located sagittally forward of a second end of the arm relative to the spine when implanted.
9. The device as claimed in claim 8, wherein said first and second members are integrally connected to said rotatable arm.
10. The device as claimed in claim 8, further comprising a second rotatable arm, said second rotatable arm coplanar and transversely aligned to said first and second members, and connected to said first member and said second member.
11. The dynamic fixation device as claimed in claim 8, wherein at least one of:
(a) one of said first and second members; and
(b) said arm;
CROSS-REFERENCE TO RELATED APPLICATIONS Priority is claimed from U.S. Provisional Patent Application No. 60/379,167 filed May 8, 2002 entitled �Dynamic Fusion System�; U.S. Provisional Patent Application No. 60/390,181 filed Jun. 19, 2002 entitled �Dynamic Fusion System�; and U.S. Provisional Patent Application No. 60/417,722 filed Oct. 9, 2002 entitled �Dynamic Fusion System,� all of which are incorporated herein by reference in their entireties. Cross reference and incorporation thereof is made to U.S. Nonprovisional patent application Ser. No. 10/406,895 filed on Apr. 4, 2003 entitled �Dynamic Fixation Device And Method of Use�.
FIELD OF THE INVENTION This invention relates generally to securement devices and, more particularly, to a flexible rod or device along a portion thereof that is capable of flexibly securing vertebrae together.
BACKGROUND OF THE INVENTION The lumbar spine absorbs a remarkable amount of stress and motion during normal activity. For the majority of the population, the healing response of the body is able to stay ahead of the cumulative effects of injury, wear, and aging, and yet still maintain stability with reasonable function. In some cases, however, the trauma or stress exceeds the ability of the body to heal, leading to local breakdown and excessive wear, and frequently also leads to local instability. Accordingly, degenerative change with age superimposed on baseline anatomy in the lumbar spine leads to problems including instability, pain and neurologic compromise in some patients. In some cases, the local anatomy may not provide the same protection to the motion segment, thereby aggravating this breakdown. Although rehabilitation, conditioning, the limitation of stress, and time to recover are effective treatments for most patients, there is a significant failure rate with persistent pain, disability and potential neurologic deficit.
Several existing patents disclose fusion devices. For example, U.S. Pat. No. 5,415,661 discloses a device that includes a curvilinear rod such that the implant supposedly restores normal biomechanical function to the vertebrae of the spine receiving the implant. However, the '661 patent does not disclose a device having structure other than a curvilinear shape that has a radius of curvature of between 0 to 180 degrees. In addition, the '661 patent does not disclose the concept of providing an anteriorly projected pivot point that models the natural articulation of the subject vertebrae by using a structure that provides a virtual rotation zone substantially identical to the rotation zone provided by the patient's vertebrae. In addition, as seen in FIG. 3 of the '661 patent, the device disclosed in the '661 patent utilizes a body 4 having a central section 10 having an anteriorly oriented position relative to its ends 6 a, 6 b. U.S. Pat. No. 6,293,949 also discloses a spinal stabilization device intended for use along the cervical vertebrae, and intended to be installed along the anterior side of the vertebrae.
SUMMARY OF THE INVENTION The present invention provides a device that can be implanted and that provides for a specified amount of forward bending motion, thereby allowing anterior sagittal rotation between the vertebrae that receive the implant. Reference is hereby made for the incorporation of the conventional descriptive terms of motion and other content presented in Clinical Anatomy of the Lumbar Spine and Sacrum by Nikolai Bogduk, third edition, published by Churchill Livingstone, 1999. Although anterior sagittal rotation or flexion between vertebrae is normal, significant anterior sagittal translation or sliding motion between vertebrae is not. Thus, by allowing some amount of rotational motion while protecting against translation, the patient's condition or injury can be protected, thus promoting the healing process, while subsequently providing some ability to rotate one vertebra relative to an adjacent vertebra, thereby allowing for improved spinal motion following surgery and recovery. Accordingly, as described herein, various implants, including a number of rod configurations having flexible portions are presented that provide a device having the ability to elongate and bend. Thus, it is a first aspect of the present invention to provide a device that elongates, and a second aspect of the present invention to provide a device that bends. More particularly, the present invention is a dynamic fixation device that includes a flexible rod portion, wherein the flexible rod portion can include a geometric shape and/or a hinge portion. These dynamic fixation devices are constructed of a material of an appropriate size, geometry, and having mechanical properties such that they bend, thus allowing the vertebrae associated with the implant to rotate relative to one another, similar to the movement of a natural spine.
In a first embodiment, an implantable elastomeric material may be used, or a surgically implantable alloy can be used that includes a geometric shape having a plurality of arms (e.g., four arms) with an interior open region between the arms. In one example of this embodiment, the geometric shape is rectangular, such that the arms of the geometric shape are situated at 90 degree angles relative to each other. Upon deformation due to flexion of the spine, the geometric shape deforms, and the 90 degree angles between the arms change such that the geometric shape expands and becomes a parallelogram. In a separate aspect of the invention, the convergence segments of the arms include partially circular comers. Alternatively, the partially circular corners may be of a different shape, such as partially triangular. In a separate aspect of this embodiment, the inside surface of the interior sidewalls of the arms of the geometric shape have an interior surface that is at an angle of 90 degrees relative to a planar surface of the geometric shape. Attached to the exterior of the geometric shape near two opposing comers are two rod arms. The rod arms allow the device to be connected to connectors, which interconnect the device to pedicle screws. In a separate aspect of this embodiment, each rod arm may be situated at different angles and locations along the geometric shape, thereby influencing the location of the projected pivot point in the plane of the geometric shape upon flexion of the spine.
While the dynamic fixation devices described herein act to naturally control the axis or region of rotation within the device, it is also advantageous to consider the disk as part of the construct. If the disk is assumed to be competent as regards axial loads as opposed to translational loads, this competence can be used to control the disk height and concomitantly, the anterior portion of the implant and vertebral construct. Thus, in yet a separate embodiment, this allows a posterior construct having a rotatable anterior-posterior segment to effectively control translation within a specific range of motion of the segmental construct. Although there is a slight translation allowed, this is well within the natural region of rotation. This embodiment preferably includes a hinged portion having pin. If anterior-posterior segment or hinged arm is considered to be an elastomeric segment, its function depends on the translational forces being less than required to cause buckling of this segment. Controlling the shape of cross-section of this segment can allow forward bending of the spine while still maintaining competence in compression in the range of forces encountered in the implanted situation.
Various embodiments have been described in this summary of the invention but such embodiments are by no means to be deemed limiting to the �present invention� and the detailed description, the figures and the claims should be referred to in there totality to appreciate the true scope and breath of the present invention. Moreover, while much of the above discussion has focused on devices and particular configurations, various aspects of the present invention relate to surgical methods, methods of making such devices and methods of use which are also to be understood as being part of the present invention.
BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side perspective view of two vertebra in a neutral position;
FIG. 6 b is a front elevation view of the device shown in FIG. 6 a; FIG. 6 c is a rear elevation view of the device shown in FIG. 6 a; FIG. 6 d is a side elevation view of the device shown in FIG. 6 a; FIG. 6 e is a side perspective view of the device shown in FIG. 6 a attached to two vertebra in a neutral position;
FIG. 10 b is a side elevation view of a portion of the device shown in FIG. 10 a; FIG. 10 c is a side perspective view of the device shown in FIG. 10 a attached to two vertebra in a neutral position; and
FIG. 10 d is a side perspective view of the device shown in FIG. 10 a attached to two vertebra in a flexed position.
The above listed drawings are not necessarily to scale.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT While the present invention will be described more fully hereinafter with reference to the accompanying drawings in which particular embodiments and methods of implantation are shown, it is to be understood at the outset that persons skilled in the art may modify the invention herein described while achieving the functions and results of this invention. Accordingly, the descriptions which follow are to be understood as illustrative and exemplary of specific structures, aspects and features within the broad scope of the present invention and not as limiting of such broad scope.
FIGS. 4 b and 4 c show dynamic fixation device 34 in its neutral and flexed positions, respectively. The effect of the substantially geometric shapes 36 a and 36 b is to produce an anteriorly projected effective pivot point 32 that substantially matches the rotational point of the vertebrae to which it is attached. Thus, the device of FIG. 4 a-4 c substantially limits translational displacement of the vertebrae to which it is attached, while still allowing some amount of flexion. In general, the bending occurring with flexion is equal to the angle change between anterior arm 38 a and anterior arm 38 b as the construct elongates. Preferably, there is a rigid connection between first rod end 14 and anterior arm 38 a, as well as a rigid connection between second rod arm 16 and anterior arm 38 b. In a separate aspect dynamic fixation device 34, the centerline of substantially geometric shapes 36 a and 36 b is offset posteriorly relative to the longitudinal axis of dynamic fixation device 34. More particularly, as shown in FIG. 4 a, dynamic fixation device 34 has a longitudinal axis L-L that passes through the centerline of first rod end 14 and second rod end 16. However, the centerline CL-CL of substantially geometric shape 36 a and 36 b is offset posteriorly to the longitudinal axis L-L of dynamic fixation device 34. This offset provides a natural fixation for the first rod end 14 to be a continuation of anterior arm 38 a, and for second rod end 16 to be a continuation of anterior arm 38 b. Referring now to FIG. 5 a, in a modification of the embodiment shown in FIG. 4 a, more than two substantially geometric shapes may be incorporated into a dynamic fixation device 34′. More particularly, the dynamic fixation device 34 having substantially geometric shapes 36 a and 36 b may be modified to include a third, fourth, fifth, or any number of additional substantially geometric shapes. For example, substantially geometric shapes 36 a and 36 b of the device shown in FIGS. 4 a illustrate two substantially diamond shaped features, respectively. However, as shown in FIG. 5 a, a third substantially diamond shape 36 c may be added to geometric shape 36 a and 36 b. Optional pins 46 may be used between the various substantially geometric shapes. Alternatively, four (not shown), five (not shown) or more geometric shapes may be grouped together to form a dynamic fixation device. Multiple substantially geometric shapes may differ in size and/or overall shaped configuration, which may be desirous depending upon the number used. For example, where three substantially geometric shapes 36 a, 36 b and 36 c are used, as in dynamic fixation device 34′, the overall size of each geometric shape is preferably smaller than the two substantially geometric shapes 36 a and 36 b illustrated in dynamic fixation device 34, as shown in FIG. 4 a. The, addition of added substantially geometric shapes projects the pivot pint 32 proportionally forward for the number of substantially geometric shapes used.
Referring now to FIGS. 6 a-6 c, interior hollow region 24 preferably includes four partially circular corners or convergence segments 26. Attached to two opposing partially circular corners or convergence segments 26 are first rod end 14 and second rod end 16. Each rod end 14 and 16 is situated at an angle of about 135 degrees from each adjacent side of the geometric shape 12. However, in an alternate aspect of this embodiment, the rod ends 14 and 16 may be situated at different angles relative to the arms of the geometric shape 12. As with device 10, partially circular comers or convergence segments 26 may be of a different shape, such as partially triangular. Equivalently, a mechanical hinge rather than an elastomeric hinge may be incorporated at convergence segments 26.
Referring now to FIG. 8 a, yet a separate embodiment of a dynamic fixation device is shown. The dynamic fixation device 62 shown in FIG. 8 a is a dynamic fixation device that features an anterior-posterior segment 64. The dynamic fixation device 62 includes a first rod end 14 having a rod arm 65 that extends at an angle a toward an anterior-posterior segment 64. Angle a is fixed in relation to pedicle screw 20 by the rigid connection between rod arm 65 and lower pedicle screw 20. Similarly, rod arm 73 is fixed by a rigid connection to the upper pedicle screw 20. Rod arm 65 of first rod end 14 is connected to anterior-posterior segment 64 at bend 66. More particularly, bend 66 forming the connection between rod arm 65 and anterior-posterior segment 64 can be a continuous structural piece such that rod arm 65 and anterior-posterior segment 64 are essentially a contiguous solid piece including bend 66. Alternatively, bend 66 may be a hinged connection with a pin that interconnects rod arm 65 to anterior-posterior segment 64. Anterior-posterior segment 64 is separated from rod arm 65 by angle β.
Referring now to FIG. 9 a-9 c, yet a separate embodiment of a dynamic fixation device is shown. Dynamic fixation device 78 includes three substantially straight arm segments. These consist of lower arm 80 a, first middle arm 80 b, and upper arm 80 c. Lower arm 80 a and upper arm 80 c connect to connectors 18 a and 18 b, respectively, which are then connected to pedicle screws 20. Using a pin 46, lower arm 80 a is hingedly connected to one end of middle arm 80 b. The opposite end of middle arm 80 b is hingedly connected (e.g., by a pin 46) to upper arm 80 c. During flexion, upper arm 80 c moves upward and forward, thereby forcing middle arm 80 b to rotate downward. Thus, the hinged connection of middle arm 80 b to upper arm 80 c allow it to upward with forward rotation, while the connection between middle arm 80 b and lower arm 80 a prevents excessive translation or over-rotation. Similar to function of the anterior-posterior segment 64 in device 62, middle arm 80 b in the present embodiment acts as an anterior-posterior segment that allows a range of motion in flexion, yet prevents the vertebrae from experiencing excessive translation. Thus, dynamic fixation device 78 allows for the upper vertebra to move up and slightly forward, yet resists excessive translation of the vertebrae to which it is attached.
As noted above, rails 90 (shown in dashed lines) interconnect the first rod member 84 to second rod member 86. Preferably, rails 90 comprise a plate 96 with hinge pins 46 situated through both ends of the plate 96. Plate 96 is shown in FIG. 10 b. In one preferred embodiment, first rod member 84 includes a first notch 98 for receiving a first hinge pin 46. Similarly, second rod member 86 includes a second notch 98 receiving a second hinge pin 46. Plates 96 span the confinement zone 100 of spring 88 and interconnect first rod member 84 and second rod member 86 while laterally containing spring 88 between rod members 84 and 86 and preventing the spring 88 for moving outside of the confinement zone 100. In a separate aspect of the present embodiment, rails 90 may be formed using a single piece. That is, the plate 96 and hinge pin 46 construction may be machined or otherwise constructed of a single piece.
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