Source: http://www.google.com/patents/US8162982?ie=ISO-8859-1&dq=7,444,563
Timestamp: 2014-08-21 13:07:19
Document Index: 738165241

Matched Legal Cases: ['Application No. 60', 'Application No. 61', 'Application No. 61', 'art, 2002', 'Application No. 07863431', 'Application No. 07852824', 'Application No. 07852824', 'Application No. 07863431', 'Application No. 07863431']

Patent US8162982 - Methods and systems for constraint of multiple spine segments - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign in<nobr>Advanced Patent Search</nobr>PatentsMethods, apparatus and systems for constraining spinous processes to elastically limit flexion of two or more adjacent spinal segments rely on placing a tether structure over at least three adjacent vertebral bodies or two adjacent vertebral bodies and the sacrum. The tether structures may be continuous,...http://www.google.com/patents/US8162982?utm_source=gb-gplus-sharePatent US8162982 - Methods and systems for constraint of multiple spine segmentsAdvanced Patent SearchPublication numberUS8162982 B2Publication typeGrantApplication numberUS 12/426,119Publication dateApr 24, 2012Filing dateApr 17, 2009Priority dateOct 19, 2006Also published asUS20090264932, US20120184998, WO2010121188A1Publication number12426119, 426119, US 8162982 B2, US 8162982B2, US-B2-8162982, US8162982 B2, US8162982B2InventorsTodd Alamin, Ian Bennett, Louis Fielding, Colin CahillOriginal AssigneeSimpirica Spine, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (113), Non-Patent Citations (31), Classifications (7), Legal Events (1) External Links: USPTO, USPTO Assignment, EspacenetMethods and systems for constraint of multiple spine segmentsUS 8162982 B2Abstract Methods, apparatus and systems for constraining spinous processes to elastically limit flexion of two or more adjacent spinal segments rely on placing a tether structure over at least three adjacent vertebral bodies or two adjacent vertebral bodies and the sacrum. The tether structures may be continuous, for example in the form of a continuous loop, or may be discontinuous, for example in the form of a loop or elongate element having at least two anchor structures for securing in bone.
placing a second tether structure over a superior spinous process and an inferior spinous process or a sacrum of a second spinal segment, the first spinal segment being adjacent and superior to the second spinal segment, wherein the second tether structure elastically couples the superior spinous process and the inferior spinous process or the sacrum of the second spinal segment so as to limit flexion therebetween without substantially limiting extension thereof,
wherein one of the first or the second tether structures is positioned anteriorly relative to the other tether structure.
2. A method as in claim 1, wherein the first tether structure or the second tether structure comprises a contiguous tether structure.
3. A method as in claim 1, wherein the inferior spinous process of the first spinal segment comprises an intermediate spinous process, and the first tether structure is disposed around a first surface of the intermediate spinous process, and wherein the superior spinous process of the second spinal segment comprises the intermediate spinous process, the method further comprises positioning the second tether structure around a second surface of the intermediate spinous process, wherein the second surface is opposite the first surface, and wherein the second tether positioned on the intermediate spinous process such that one tether is anteriorly disposed relative to the other tether structure.
4. A method as in claim 1, wherein one of the spinous processes in the first or the second spinal segment is disposed on an L4 or L5 vertebrae, or disposed on the sacrum.
5. A method as in claim 1, wherein spaces between adjacent spinous processes are free from structure which would inhibit extension therebetween.
6. A method as in claim 1, wherein the first or the second tether structure comprises one or more band elements in series with one or more compliance members, wherein the one or more compliance members provide the elasticity to limit the flexion.
7. A method as in claim 1, wherein the first or the second tether structure comprises at least two compliance members, the method further comprising positioning the compliance members symmetrically to lie on opposite sides of the spinous processes, and wherein the at least two compliance members provide the elasticity to limit the flexion.
8. A method as in claim 1, wherein the first or the second tether structure provides an elastic stiffness in compression below 3 N/mm.
9. A method as in claim 8, wherein the elastic stiffness in compression is below 0.5 N/mm. Description
The present application is a continuation-in-part of U.S. Patent Application No. PCT/US2007/081822 filed Oct. 18, 2007, which claims priority to U.S. Provisional Patent Application No. 60/862,085 filed Oct. 19, 2006. The present application also is a non-provisional of, and claims the benefit of U.S. Provisional Patent Application No. 61/158,892 filed Mar. 10, 2009. The entire contents of each of the above applications is incorporated herein by reference.
As illustrated in FIG. 2, an implant 10 as described in the '017 publication, typically comprises an upper strap component 12 and a lower strap component 14 joined by a pair of compliance members 16. The upper strap 12 is shown disposed over the top of the spinous process SP4 of L4 while the lower strap 14 is shown extending over the bottom of the spinous process SP5 of L5. The compliance member 16 will typically include an internal element, such as a spring or rubber block, which is attached to the straps 12 and 14 in such a way that the straps may be �elastically� or �compliantly� pulled apart as the spinous processes SP4 and SP5 move apart during flexion. In this way, the implant provides an elastic tension on the spinal processes which provides a force that resists flexion without substantially limiting extension of the segment. The force increases as the processes move further apart. Usually, the straps themselves will be essentially non-compliant so that the degree of elasticity or compliance may be controlled and provided solely by the compliance members 16.
BRIEF SUMMARY OF THE INVENTION The present invention provides spinal implants, implant systems, and methods for constraining spinous processes to elastically limit flexion of two or more adjacent spinal segments. As used herein, the phrase �spinal segment� is synonymous with the phrase �functional spinal unit (FSU)� and intended to mean the smallest physiological motion unit of the spine that exhibits biomechanical characteristics similar to those of the entire spine. A spinal segment or FSU consists of two adjacent vertebrae, the intervertebral disc and all adjoining ligaments between them and excludes other connecting tissues such as muscles. The three-joint complex that results is sometimes referred to as the �articular triad.� Another term for the FSU is spinal motion segment. These definitions are taken from White A A, Panjabi M M. (1990), Clinical Biomechanics of the Spine, Philadelphia, J B Lippincott. The methods comprise placing a tether structure over the spinous processes of at least three adjacent vertebral bodies, or over the spinous processes of two adjacent vertebral bodies and a sacrum, wherein the structure elastically couples the at least two non-adjacent spinous processes or one spinous process and a non-adjacent sacrum. The spinous processes and optionally a sacrum can be interconnected and elastically coupled in a variety of ways.
In another aspect of the present invention, a spinal implant comprises a contiguous tether structure adapted to circumscribe at least two non-adjacent spinous processes, or in other instances, to an anchor location on the sacrum and one non-adjacent spinous process. At least a portion of the tether structure will provide an elastic resistance to elongation in response to an elongation force which results from flexion of the spinal segments between the non-adjacent spinous processes and/or between the one non-adjacent spinous process and the sacrum. The tether structure limits flexion therebetween without substantially limiting extension therebetween. A first portion and a second portion of the tether structure may extend between the non-adjacent spinous processes or between the one non-adjacent spinous process and the sacrum. The first and second portions of the tether structure may be disposed symmetrically on opposite sides of the spinous processes and they also may be parallel to one another. Often, the implant will include at least two compliance members positioned as part of the tether structure such that they will lie symmetrically on opposite sides of the spinous processes when implanted. In still other embodiments, the contiguous tether structures will include at least four such compliance members. The compliance members will typically be coupled to non-compliant and/or cable components of the tether structure so that it is the compliance members which provide most or all of the compliance or elasticity in the implants. Exemplary compliance structures are illustrated in U.S. Patent Publication No. 2005/02161017 A1 (now U.S. Pat. No. 7,458,981).
In some embodiments, the contiguous tether structure will be continuous so that the structure forms a loop which may be placed over the non-adjacent spinous processes. Such continuous �loop� tether structures will usually be maintained on the spinous processes by friction and interference fit, but in some cases could be modified to permit further attachment by stapling, welding, gluing, suturing, or the like. In other embodiments, the contiguous tether structure will be discontinuous and will have two ends which are adapted for anchoring for direct attachment to the bone. Such discontinuous tether structures will be suitable for anchoring in the sacrum.
BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic diagram illustrating the lumbar region of the spine including the spinous processes (SP), facet joints (FJ), lamina (L), transverse processes (TP), and sacrum (S).
DETAILED DESCRIPTION OF THE INVENTION The present invention provides methods, devices, and systems for constraining the flexion of two or more adjacent spinal segments by elastically restraining two or more spinous processes or at least one spinous process and an anchor region on a sacrum. Such restraint is achieved using a tether structure which spans at least three spinous processes or a pair of spinous processes and the sacrum (more specifically, the spinous processes on L4 and L5 as well as an anchor region on the sacrum). The tethers used will typically be in the form of a contiguous tether structure. By �contiguous� it means that the tether may comprise one or more elongate component(s), such as strap(s), cable(s), ribbon(s), or the like, which may be constructed or modified to provide for a desired elastic coupling of one or more spinous processes and optionally an anchor location on the sacrum. Alternatively, the �contiguous� tether structures may comprise a plurality of components, such as the straps, bands, cables, or the like, as mentioned above, together with compliance structures which provide for the desired elastic coupling. In the latter case, the straps, etc., will typically be non-compliant, effecting little or no elongation in response to tension, while the compliance members will provide the desired level of elastically coupling. Combinations of compliant elongate components and separate compliance members will also be possible.
The contiguous tether structures may be continuous or discontinuous. The �continuous� contiguous tether structures will typically be formed into a loop so that the loop may be placed over a pair of spinous processes, typically non-adjacent spinous processes separated by at least one intermediate spinous process. The �discontinuous� contiguous tether structures, in contrast, will have at least two free ends adapted with anchor structures for anchoring to bone, typically to anchor regions on a sacrum.
Referring now to FIG. 4, a second exemplary continuous tether structure 24 is similar to tether 20, except that it is provided with separate compliance structures 26 a-26 d arranged symmetrically on opposite sides of the �ridge� of spinous processes. The tether structure 24 is shown placed on the spinous processes SP2-SP4 on vertebral bodies L2-L4, it will be appreciated that tether structures 20 and 24 could be placed on any three contiguous spinous processes, typically in the lumbar region. Various combinations of elasticities may be used amongst the four compliance members 26 a-26 d. For example, all four compliance members may have the same elasticity. Alternatively, all four compliance members may have an elasticity different from one another. In some embodiments, the two superior compliance members 26 a, 26 b may have a first elasticity and the two inferior compliance members 26 c, 26 d may have a second elasticity different than the first. This allows the resistance to flexion to be varied at different levels of the spinal segment. In still other embodiments, at one motion segment level, the elasticity of a left compliance member 26 a may be different than the right compliance member 26 b. One of skill in the art will appreciate that any combination of elasticities may be employed in a tether structure having multiple compliance members. This applies to any of the embodiments disclosed herein having multiple compliance members.
The continuous tether structures of the present invention may be formed in multiple interconnected loops, as shown, for example, in FIGS. 5-8. The multiple loops will usually include an outer or peripheral loop which encircles or otherwise engages at least three or more adjacent spinous processes. One or more inner loops may also be provided to engage or encircle one, two, or possibly more of �intermediate� spinous processes within the group which is being restrained.
Continuous tether structure 40, as shown in FIG. 6, also comprises an outer loop 42 (shown to encircle SP3-SP5) and an inner loop 44 (shown to encircle SP4 and SP5 only), similar to the tether structure 30 of FIG. 5. An upper loop portion 46, however, is shown attached to sliding attachment members 48 a and 48 b, which attachment members allow the upper loop structure 46 to be tightened or �cinched� over the top of SP4. The tether structure 40 is also shown with four symmetrically placed compliance members 50 a-50 d, but it will be appreciated that the tether structure could include only two or even no compliance members, while retaining the adjustably placed upper loop structure 46. As discussed above, any combination of elasticities may be used amongst the compliance members.
FIG. 8A illustrates another embodiment similar to that of FIG. 8, except here the tether structure is coupled to two adjacent spinous processes at a first level of the spinal segment and another portion of the tether structure having compliance members is then coupled to a superior spinous process so that flexion is restricted in the suprajacent segment. This may be used, for example, when the spinal segment is fused. In FIG. 8A, a first part of the tether structure consists of a tether 102 circumscribing two adjacent spinous processes SP3-SP4. The tether 102 is disposed around a superior surface of a superior spinous process SP3 and also around an inferior surface of an inferior spinous process SP4. A fusion according to methods known in the art has been performed to fuse L3-L4 together at, or across the level designated by F and therefore tether 102 will often be substantially inelastic in order to prevent flexion between L3-L4 thereby facilitating the fusion F, although some micromotion is still permitted. The tether structure also has a second tether 104 disposed around a superior surface of a superior spinous process SP2 superior to the fused region. The ends of the second tether 104 are coupled with the first part of the tether structure 102, or in alternative embodiments, the ends of the second tether 104 are continuous forming a closed loop and thus are disposed under the inferior surface of SP3. Compliance members 106 a, 106 b provide a force resistant to flexion of the L2-L3 motion segment supradjacent to the fused region F. This helps to more evenly distribute and possibly lessen loading applied to the fused region, to the level superior to the fused region, and to tethers 102 and 104. The tether structure may also help to reduce excessive motion. Additional details on the use of a tether structure concomitantly with fusion are disclosed in U.S. Provisional Patent Application Nos. 61/158,892 and 61/158,886, both filed on Mar. 10, 2009, and both of which the entire contents are incorporated herein by reference.
The contiguous tether structures of the present invention will not always have a continuous structure. As shown in FIGS. 9 and 10, the tether structures may also have a discontinuous geometry including at least two ends adapted to anchor to bone, typically to a surface of the sacrum which generally lacks structure for attaching the lower end of a loop. As shown in FIG. 9, an exemplary discontinuous tether structure 80 comprises a U-shaped tether or band structure including compliance members 82 a and 82 b. A pair of anchor structures 84 a and 84 b are provided on two ends of the tether structure 80 and are adapted to be anchored into the face of the sacrum S, as illustrated. In this way, the tether structure 80 can provide for controlled elastic restraint of the spinal segments between SP4 and SP5 and between SP5 and the sacrum. Additional details on sacral attachment may be found in U.S. Provisional Patent Application No. 61/149,224, filed Feb. 2, 2009, and U.S. patent application Ser. No. 11/827,980, filed Jul. 13, 2007. The entire contents of each of these applications is incorporated herein by reference.
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