Patent Grant
8840646
Spinal stabilization procedures are performed and include placement of devices between vertebral bodies in the disc space or along the spinal column. For example, varieties of inter-body fusion devices are widely used following partial or total discectomies to fuse adjacent vertebrae. Artificial disc devices can be placed in the disc space if motion preservation is desired. Still other stabilization devices contemplate the attachment of plates, rods or tethers extradiscally along the vertebrae. Still others are positioned between spinous processes.
In some procedures, the spinous process of the patient may be damaged or otherwise compromised such that it is not capable of supporting an interspinous stabilization element in a stabilization procedure. There remains a need for devices for spinal stabilization that replace the spinous process so that interspinous stabilization procedures can be completed even if the spinous process of the patient is compromised.
Devices and methods for replacing one or more spinous processes of a patient include a replacement body with a lamina portion positionable anteriorly toward the spinal canal along with a spinous process portion extending posteriorly from the lamina portion to replace a removed spinous process. Connecting elements extend from opposite sides of the body for connection to the vertebral body with anchors.
According to one aspect, an artificial spinous process implant includes a replacement body with a lamina portion and a spinous process portion. The lamina portion lies generally along an anterior side of the replacement body and extends from a superior end of the replacement body to an inferior end of the replacement body. The lamina portion also includes opposite lateral sides extending between the superior and inferior ends of the replacement body. The spinous process portion is located between the lateral sides of the lamina portion and extends from said lamina portion toward a posterior side of the replacement body opposite the anterior side. The spinous process portion further extends between the superior and inferior ends of the replacement body while in a transverse orientation to the first plane.
According to another aspect, an artificial spinal process implant includes a replacement body. The replacement body includes a lamina portion lying along an anterior side of the replacement body that extends in a direction from a superior end of the replacement body toward an inferior end of the replacement body. The lamina portion further includes opposite lateral sides extending in a direction between the superior end and the inferior end of the replacement body. The replacement body also includes a spinous process portion extending from the lamina portion toward a posterior side of the replacement body opposite the anterior side. The spinous process portion further extends in a direction between the superior and inferior ends of the replacement body. The implant also includes a pair of elongated connecting elements extending in opposite directions from the replacement body and away from the spinous process portion.
According to a further aspect, a method for stabilizing adjacent vertebrae of a spinal column comprises: accessing the spinal column from a posterior approach; removing at least a portion of at least one spinous process and/or lamina of a vertebra; engaging an artificial spinous process implant to the vertebra; and positioning an interspinous implant between the artificial spinous process implant and a spinous process of a second vertebra adjacent to the vertebra.
In another aspect, an artificial spinous process implant includes at least one through-hole for receiving a tether to secure an interspinous implant thereto.
In another aspect, an artificial spinous process implant includes at least one notch for engagement by a distractor instrument to apply distraction forces between the vertebra to which the implant is engaged and an adjacent vertebra.
In another aspect, an artificial spinous process implant includes lateral support members extending along opposite sides of a spinous process portion of the implant to provide support for an interspinous implant engaged to the artificial spinous process implant. In one form, interspinous implants are engaged to the spinous process portion on superior and inferior sides of the pair of lateral support members.
In another aspect, an artificial spinous process implant includes a replacement body with a lamina portion and a spinous process portion. The spinous process portion includes opposite sides tapering in width from a mid-portion of the spinous process portion toward at least one of the superior and inferior ends of the replacement body.
In another aspect, a posterior spinal stabilization system includes a replacement body engageable to a first vertebra and an interspinous spacer implant engageable to the spinous replacement body and a spinous process of a second vertebra.
These and other aspects will be discussed further below.
For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated devices, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates.
Spinous process implants include a replacement body implantable adjacent to the spinal column to replace a spinous process of a vertebra. The replacement body can also reinforce or replace all or a portion of a lamina resected, removed, or altered along with the spinous process. The replacement body of the implant includes a lamina portion positionable adjacent the spinal canal and in contact with or adjacent to the lamina. The replacement body also includes a spinous process portion extending posteriorly from the lamina portion to replace the removed spinous process. The replacement body includes connecting elements extending therefrom for engagement with anchors or other devices engaged to the vertebral body to secure the replacement body in position in the patient.
In
Spinal column segment 10 further includes a superior or cephaladly located vertebra V2 and an inferior or caudally located vertebra V3. Superior disc space D1 is located between vertebrae V1, V2 and inferior disc space D2 is located between vertebrae V1, V3. Superior vertebra V2 includes superior spinous process SP2 and inferior vertebra V3 includes inferior spinous process SP3. Spinous process implant 20 is located between spinous processes SP2, SP3. As further shown in
An interspinous implant 12 is provided between spinous process SP2 and spinous process implant 20. Interspinous implant 12 is abuttingly engaged with spinous process SP2 and spinous process portion 24 to provide and maintain separation between spinous process SP2 and spinous process portion 24. In one embodiment, interspinous implant 12 is the DIAM™ Spinal Stabilization System of Medtronic, Inc. employed for spinal decompression surgery between spinous processes of the patient to alleviate spinal stenosis. Interspinous implant 12 is placed between the spinous process SP2 and spinous process implant 20 to act as a shock absorber and reduce loads on the surrounding vertebrae and restore the natural function of the joint. The core of interspinous implant 12 can be made of silicone or other compressible, resilient material. The core is surrounded with an outer mesh, and the implant can be tethered to the spinous processes or laminae of the adjacent vertebral bodies. The flexible properties of the interspinous implant 12 may also protect the integrity of the spinous process.
Interspinous implant 12 includes opposite generally U-shaped ends to fit around the respective spinous process and spinous process implant 20. One of the U-shaped ends receives the spinous process SP2 or SP3 therein and the other of the U-shaped ends receives the artificial spinous process implant 20 therein. The U-shaped ends cradle the spinous process implant 20 and spinous process SP2 or SP3 to maintain the interspinous implant 12 in position when positioned therebetween.
Other procedures contemplate that the interspinous implant 12 is made from a rigid or more rigid material such as PEEK, titanium, stainless steel, polymers, metals and metal alloys, or ceramics, or includes any other suitable form for positioning between spinous processes and spinous process implant 20. For example, one form interspinous implant 12 is a plate, clamp or other device that is engaged to spinous process implant 20 and one or more other spinous processes of the patient or other spinous process implants. In yet other embodiments, multi-level stabilization procedures are contemplated by positioning a second interspinous implant 12 between spinous process implant 20 and spinous process SP3. In another embodiment, a single level stabilization procedure is contemplated by positioning a single interspinous implant 12 between spinous process implant 20 and spinous process SP3. In still another procedure, an interspinous implant 12 is positioned between two artificial spinous process implants 20 engaged to respective ones of first and second vertebrae.
Spinous process implant 20 includes replacement body 21 that is formed as a single, integral unit with lamina portion 22 and spinous process portion 24. Other embodiments contemplate that implant 20 includes multiple components assembled or fastened together to form the replacement body. Lamina portion 22 is formed by a plate-like body and includes a flat anterior surface 38 that is oriented toward the spinal canal when implanted and contacts or is positioned adjacent to the lamina of vertebra V1. In other embodiments, lamina portion 22 includes a superior and anteriorly protruding ledge 32 that extends to superior end 50 of replacement body 21, as shown in dashed lines in
Spinous process portion 24 forms a plate-like posterior extension extending from and transversely oriented to lamina portion 22 to a posterior side 54, and between superior and inferior ends 50, 52. In one form, lamina portion 22 forms a plate-like portion extending orthogonally to the sagittal plane and spinous process portion 24 forms a plate-like portion that lies within or generally parallel to the sagittal plane. Spinous process portion 24 further includes opposite side surfaces 56, 58 extending between lamina portion 22 and posterior side 54, and further extending between superior and inferior ends 50, 52. Opposite side surfaces 56, 58 taper from a maximum thickness adjacent a mid-portion 60 toward the respective ends 50, 52. The tapered side surfaces facilitate engagement with the interspinous implant 12. In other embodiments, non-tapered configurations for opposite side surfaces 56, 58 are contemplated. The transitions between posterior side 54 and superior and inferior ends 50, 52 are beveled as shown in
Spinous process portion 24 also includes a pair of identical opposite support members 62 (only one shown) extending from lamina portion 22 and laterally outwardly from and along side surfaces 56, 58 toward posterior side 54. Support members 62 include a superior support surface 62a and an inferior support surface 62b to provide a location along which the interspinous implant 12 resides against or is positionable into abutting engagement with when engaged to spinous process implant 20. Support surfaces 62a, 62b are concavely curved and form a smooth transition between lamina portion 22 and the portion of support members 60 along spinous process portion 24 to prevent the formation of sharp, abrupt edges and conform to the shape of the interspinous implant to provide a good fit therewith and minimize stress concentrations in the interspinous implant positioned thereagainst. Support members 62 extend along the mid-portion of spinous process portion 24 and divide it into an inferior and superior portion to receive respective adjacent ends of an inferior and superior interspinous implant. In the illustrated embodiment, the height of the superior portion from support members 62 to superior end 50 is slightly greater than the height from support members 62 to inferior end 52 to accommodate the interspinous implants. Other embodiments contemplate other relative heights, including the same heights for the superior and inferior portions.
Spinous process portion 24 also includes a superior through-hole 64 and an inferior through-hole 66 extending between and opening at the respective side surfaces 56, 58. Through-holes 64, 66 provide a location through which tethering elements can be positioned to secure one or two interspinous process spacers to spinous process implant 20. Through-holes 64, 66 are elongated in the anterior-posterior direction when spinous process implant 20 is implanted to provide some adjustability in the tether location therethrough. The elongated through-holes can also accommodate tethers formed as flat, wide bands. Other embodiments contemplate other shapes for through-holes 64, 66, including round through-holes, square or rectangular through-holes, and multiple through-holes in side-by-side relation in the anterior to posterior direction. Still other embodiments contemplate a spinous process implant 20 without through-holes, or an implant 20 with a single through-hole. In still other embodiments, one or both of the through holes includes a side that opens posteriorly in posterior side 54 so that the tether can be side-loaded into the bore.
Spinous process portion 24 also includes a superior notch 68 in superior end 50 and an inferior notch 70 in inferior end 52. Notches 68, 70 provide a secure and reliable location in which a distraction instrument can be received to exert distraction forces between the vertebrae V1 and V2 or the vertebrae V1 and V3 through the artificial spinous process implant 20 and the respect spinous processes SP2, SP3. Notches 68, 70 are formed adjacent the lamina portion 22 so that distraction forces are applied more toward the central axis of the vertebral bodies. Furthermore, lamina portion 22 forms an anterior wall at ledge 32 to prevent the distractor from migrating into the spinal canal during distraction. Notches 68, 70 are U-shaped and are longer in the anterior-posterior direction than their respective depth into spinous process portion 24 to preserve the integrity of spinous process portion 24. Other embodiments contemplate other shapes for notches 68, 70, including V-shapes, semi-circular shapes, and irregular shapes, for example. Still other embodiments contemplate a spinous process implant 20 without notches 68, 70, or an implant 20 with a single notch.
In another embodiment, superior end 50 is formed with a concave, elongated notch 51 extending from lamina portion 22 to or adjacent to posterior side 54, such as shown in dashed lines in
As shown further in
Connecting element 26 includes an inner end 26a integrally formed with support member 62 where it transitions between lamina portion 22 and spinous process portion 24. Connecting element 26 includes an elongated, rod-like body 26c extending from inner end 26a to an opposite outer end 26b spaced from replacement body 21. Body 26c includes flats 26d along one or more outer surfaces thereof to provide engagement platforms with the respective anchor 16, 18. Flats 26d are arranged to engage the anchor in a keyed arrangement so that rotation of the connecting element 26 in the anchor is prevented by contact of the flats 26d with surfaces in the anchor to prevent rotation of connecting elements 26, 28, and in turn replacement body 21, relative to the respective anchor 16, 18 and vertebra V1. Body 26c includes an outer portion 26e arranged generally orthogonally to the sagittal plane, and an oblique portion 26f extending between outer portion 26e and inner end 26a that is obliquely oriented to outer portion 26e. Oblique portion 26f locates outer portion 26e adjacent to superior end 50 and in a location for engagement with anchors engaged to the pedicle of vertebra V1 when replacement body 21 is located in the desired position.
Outer portions 26e of connecting elements 26, 28 are situated to lie on a common axis L in a linear arrangement. Other embodiments contemplate non-linear profiles for connecting elements 26, 28, as discussed further below with respect to the embodiment of
Another embodiment spinous process implant 120 is shown in
Body portions 126a, 128a include an outer surface formed by a series of flat surfaces connected to one another at corners around the respective body portion 126a, 128a to define a non-circular outer surface profile around the respective body portion. The non-circular profile is engaged to the respective anchor 16, 18 in a non-rotating manner so that rotation of replacement body 121 is prevented, maintaining superior and inferior ends 150, 152 in alignment along the vertebra V1.
The replacement bodies and connecting elements of spinous process implants 20, 120 can be made from any suitable biocompatible material. Contemplated materials include metals and metal alloys, polymers, ceramics, elastomers, bone, carbon fiber, and PEEK, for example. The material can be homogenous or composite, and different portions of the implants can be made from different materials to provide desired performance characteristics. The anchors 16, 18 can be any suitable anchor for securing the implant 20, 120 to vertebra V1. In the illustrated embodiment of
In use, spinous process implants 20, 120 are implanted for posterior spinal stabilization with one or more interspinous implants as a stand-alone procedure or in conjunction with other procedures, such as interbody fusion procedures or interbody motion-preserving stabilization procedures. In one procedure, spinous process implants 20, 120 are employed when a spinous process or a lamina of one or more vertebrae is damaged such that it is not capable of supporting an interspinous process implant. Interspinous implant 20, 120 is attached to the damaged vertebrae so that the stabilization procedure with the interspinous spacer can be completed. Interspinous implant 20, 120 allows the surgeon to complete the interspinous stabilization procedure without resorting to an interbody fusion procedure or other suboptimal treatment.
The interbody procedures can be performed in the same or in different vertebral levels than those stabilized with interspinous implant 12 and spinous process implant 20, 120. Implant 20, 120 can be positioned into the patient through a small posterior incision in the patient of sufficient size to admit the implant and instrumentation. Following the incision, muscle and tissue is moved aside if and as needed for removal of one or more compromised spinous processes and placement of the artificial spinous process implant into position along vertebra V1 and into engagement with anchors 16, 18. The connecting elements of implant 20, 120 can be provisionally captured in anchors 16, 18 to allow for slidable medial-lateral adjustment. After the artificial spinous process implant is positioned into the desired location relative to vertebra V1, it is secured in position with anchors 16, 18. Distraction of one or more vertebral levels is then performed as necessary with the artificial spinous process implant 20, 120 and the respective spinous processes SP2, SP3. One or more interspinous implants 12 are then positioned between spinous process implant 20, 120 and the corresponding spinous processes SP2, SP3. Distraction is removed if necessary. One or more tethers are engaged between the interspinous implant 12 and spinous process implant 20, 120 to secure the interspinous implant 12 in position relative to the implant 20, 120 and the supported spinous process SP2, SP3. The interspinous spacer 12 and artificial spinous process implant 20, 120 provide support of the adjacent vertebrae, resisting settling and compression of the space between the vertebrae while allowing at least limited motion of the supported vertebrae.
While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character. All changes and modifications that come within the spirit of the invention are desired to be protected.
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| 2722087 | Jan 1996 | FR |
| 2722088 | Jan 1996 | FR |
| 2724554 | Mar 1996 | FR |
| 2725892 | Apr 1996 | FR |
| 2730156 | Aug 1996 | FR |
| 2775183 | Aug 1999 | FR |
| 2 799 948 | Oct 1999 | FR |
| 2816197 | May 2002 | FR |
| 2799948 | Apr 2007 | FR |
| 02-224660 | Sep 1990 | JP |
| 09-075381 | Mar 1997 | JP |
| 2003-079649 | Mar 2003 | JP |
| 988281 | Jan 1983 | SU |
| 1484348 | Jun 1989 | SU |
| WO 9426192 | Nov 1994 | WO |
| WO 9426195 | Nov 1994 | WO |
| WO 9820939 | May 1998 | WO |
| WO 2004047691 | Jun 2004 | WO |
| WO 2004084743 | Oct 2004 | WO |
| WO 2005009300 | Feb 2005 | WO |
| WO 2005044118 | May 2005 | WO |
| WO 2005110258 | Nov 2005 | WO |
| WO 2006064356 | Jun 2006 | WO |
| WO 2007034516 | Mar 2007 | WO |
| Entry |
|---|
| “Dispositivo Intervertebrale Ammortizzante DIAM,” date unknown, p. 1. |
| “Tecnica Operatoria Per II Posizionamento Della Protesi DIAM,” date unknown, pp. 1-3. |
| “Wallis Operative Technique: Surgical Procedure for Treatment of Degenerative Disc Disease (DDD) of Lumbar Spine,” date unknown, pp. 1-24, Spine Next, an Abbott Laboratories company, Bordeaux, France. |
| Aota et al., “Postfusion Instability at the Adjacent Segments After Rigid Pedicle Screw Fixation for Degenerative Lumbar Spinal Disorders,” J. Spinal Dis., Dec. 1995, pp. 464-473, vol. 8, No. 6. |
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| Cousin Biotech, Dispositif Intervertebral Amortissant, Jun. 1998, pp. 1-4. |
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| McDonnell et al., “Posterior Atlantoaxial Fusion: Indications and Techniques,” Techniques in Spinal Fusion and Stabilization, Hitchon et al., eds., 1995, pp. 92-106, Ch. 9, Thieme, New York. |
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| Scarfò, “Instability/Stenosis: Holistic Approach for Less Invasive Surgery,” date unknown, University of Siena, Siena, Italy. |
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| Number | Date | Country | |
|---|---|---|---|
| 20080281360 A1 | Nov 2008 | US |
