WO2007089975A1 - Artificial spinous process for the sacrum and methods of use - Google Patents

Artificial spinous process for the sacrum and methods of use Download PDF

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Publication number
WO2007089975A1
WO2007089975A1 PCT/US2007/060571 US2007060571W WO2007089975A1 WO 2007089975 A1 WO2007089975 A1 WO 2007089975A1 US 2007060571 W US2007060571 W US 2007060571W WO 2007089975 A1 WO2007089975 A1 WO 2007089975A1
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WO
WIPO (PCT)
Prior art keywords
bearing face
sacrum
spinous process
implant
mount
Prior art date
Application number
PCT/US2007/060571
Other languages
French (fr)
Inventor
Kent A. Anderson
Eric C. Lange
Thomas A. Carls
Aurelien Bruneau
Jean Taylor
Original Assignee
Warsaw Orthopedic, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Warsaw Orthopedic, Inc. filed Critical Warsaw Orthopedic, Inc.
Publication of WO2007089975A1 publication Critical patent/WO2007089975A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7055Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant connected to sacrum, pelvis or skull
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7062Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
    • A61B17/7067Devices bearing against one or more spinous processes and also attached to another part of the spine; Tools therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/48Other medical applications
    • A61B5/4806Sleep evaluation
    • A61B5/4818Sleep apnoea
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S606/00Surgery
    • Y10S606/901Thoracic stabilizer

Definitions

  • the present application is directed to devices to mount with the sacrum, and more specifically to devices that attach to the sacrum and provide a support for positioning an implant between the sacrum and fifth lumbar vertebrae.
  • the spine is divided into regions that include the cervical, thoracic, lumbar, m ⁇ sacrococcygeal regions.
  • the cervical region includes the top seven vertebrae identified as Cl -C7.
  • the thoracic region includes the next twelve vertebrae . idea titled as Tl -Tl 2.
  • the lumbar region includes five vertebrae L1-L5.
  • the sacrococcygeal region includes nine fused vertebrae comprising the sacrum comprising S.1-S5 vertebrae and four or five rudimentary members that form the coccyx.
  • the sacrum is shaped like an inverted triangle with the base at the top.
  • the sacrum acts as a wedge between the two iliac hones of the pelvis and transmits the axial loading- forces of the spine to the pelvis and lower extremities.
  • Hie sacrum Is rotated anteriorly with the superior endplate of the S 1 vertebrae angled from about 30 to about 60 degrees in the horizontal plane.
  • the Sl vertebrae includes a spinous process aligned along a r ⁇ dge called the medial sacral crest.
  • the spinous process on the S 1 vertebrae may not be well defined and therefore not adequate for supporting an implant.
  • One example of this dilemma is the inability of the spinous process to adequately support an interspinous process implant positioned between the L5 and. Si spinous processes. Summary'
  • the present application is directed to devices that mount to the sacrum and methods of use.
  • One embodiment of the device may include first aad second anchors that mount to the sacrum, and first and second lateral extensions coupled to the anchors to secure the device to the sacrum.
  • a bearing face having a width is positioned between the lateral extensions.
  • the face may have a height in ati anterior-posterior direction greater than the spinous process of the sacrum. Further, the bearing face may be oriented in a superior direction when the device is mounted to the sacrum.
  • Am implant may be supported by the device to space the sacrum a «d LS vertebrae.
  • the implant may be an interspinous device and positioned between the L5 spinous process &n ⁇ the bearing face.
  • the implant is supported at least in part, on the bearing face.
  • Figure 1 is a rear view of a system having a base and an implant according to one embodiment
  • Figure 2 Is a top view of the base fastened to the sacrum according to one embodiment.
  • Figure 3 is a perspective view illustrating an inferior portion of a base according to one embodiment.
  • Figure 4 is a perspective view illustrating a superior portion of a base according to one embodiment.
  • Figure 5 Is a perspective view of a base fastened to the sacrum by a pair of anchors according to one embodiment
  • Figure 6 is a perspective view illustrating a superior portion of a base according to one embodiment
  • Figure 7 is a perspective view of an implant according to one embodiment.
  • Figure 8 is a side view of a mount according to one embodiment.
  • Figure 9 is a perspective view of a base according to one embodiment.
  • Figure 10 L is a top view of a base according to one embodiment.
  • Figure 11 is a perspective view of a base according to one embodiment. Detailed Description
  • the present application is directed to a base that, attaches to the $acmm and includes a. bearing face to support an implant
  • Figure 1 illustrates one embodiment having a base 20 that attaches to the sacrum ⁇ Q2>
  • a mount.22 extends posteriorly outward from the base 20 and is sized to contact an inferior portion of an implant 50.
  • the implant 50 extends between the mount 22 and the spinous process 103 of the L5 vertebrae 101.
  • the base 20 includes the mount 22 and one or more extensions 21 as illustrated in Figures 2, 3, and 4.
  • Mount 22 includes a bearing face 26 that faces m a superior direction when the base 20 is mounted to the sacrum 102. Bearing face 26 has a. height H and width W to support, the implant 50.
  • the bearing face 26 has a height H in an anterior-posterior direction to extend posteriorly outward from the sacreim 102 a distance to support the implant 50, In one embodiment, the height H is greater than a height of Che sacral spinous process 105. Ih one embodiment; the width W of the bearing face 26 is substantially constant along the height H. In another embodiment, the width W varies along the height H. Bearing face 26 may extend outward from the sacrum 102 at a variety of angles, In one embodiment the width W of the bearing face 26 is substantially equal to a width of the L5 spinous process 103. Bearing surface 26 may be substantially planar, substantially curved, or include a combination having planar and curved sections.
  • Mount 22 further includes first and second sections 24, 25 that extend from the bearing face 26.
  • Sections 24, 25 are positioned along lateral sides of the sacral spinous process 105 when the base 20 is mounted to the sacrum 102.
  • Sections 24, 26 may have a length to extend outward and contact the sacrum 102, or may have a lesser length be spaced from the sacrum 102 when tire base 20 is mounted.
  • An intermediate section 49 may extend inferiorly from the bearing face 26. Intermediate section 49 may have a width to extend between the first and second sections 24, 25.
  • a recess 31. is formed on an underside of the mount 22 and is sized to extend over the entirety or a portion of the sacral spinous process 105.
  • Apertures 30 may extend through the first and second sections 24, 25 for receiving a tether as will be described Ln more detail below, Apertures 30 may also be used for grasping the base 20 during insertion and positioning into the patient.
  • a superior edge of the bearing face 26 may include a Up 28 as illustrated in Figure 2, Lip 28 aligns the mount 22 on the sacrum 102, and specifically aligns the mount 22 on the sacral lamina.
  • the height. H of the bearing surface includes the Hp 28. In one embodiment, the height H excludes the lip 28. Lip 28 may have the same width as the bearing face width " W, or a different width.
  • a notch 29 may be formed in an inferior edge of the intermediate section 49, Notch 29 is sized to accommodate the SI spinous process .105 of the sacrum 102.
  • the lip 28 and notch 29 are centered about, a centerline of the bearing face 26.
  • the centerline of the bearing face 26 is aligned with the medial sacral crest.
  • One or .more extensions 21 extend outward from the mount 22 to contact the face of the sacrum 102.
  • Extensions 21 may include one or more apertures 23 to receive ati anchor 40 to connect the base 20 to the sacrum.
  • extensions 21 have a length to position the apertures 23 at the sacrum pedicles for good fastener fixation.
  • anchors 40 comprise ahead 41 that contacts the edges of the aperture 23 &nd a shaft 42 that extends into the sacrum 102.
  • ⁇ n one embodiment as illustrated in Figure iée extensions 21 have a superior edge that is substantially aligned with, the superior edge of the bearing face 26.
  • Figures 5 and.6 illustrate another embodiment of a base 20 comprising a mount 22 atid extensions 21.
  • Figure 5 does not include an implant 50.mounted between the L5 spinous process 103 and the mount 22.
  • Mount 22 comprises first and second sections 24, 25 that connect together at a superior face thai forms the bearing face 26.
  • Bearing face 26 is positioned at the apex of the sections 24, 25 and is positioned on the superior face of the sacral spinous process 105.
  • Bearing face 26 has a height H to extend outward from the sacrum 102 beyond the posterior edge of the sacral spinous process 105.
  • Sections 24, 25 extend iiiferiorly outward from the bearing face 26 and are positioned along lateral edges of the spinous process 105.
  • the sections 24, 25 further angle laterally outward in an inferior direction giving the mount 22 a substantially V-shape. ⁇ n one embodiment; a height of the sections 24, 25 may be substantially equal to the height of the bearing face 26 as illustrated in Figure 5. Bearing face 26 and sections 24, 25 form a recess 31 sized to fit over the spinous process ] 05.
  • One or .more apertures 30 may extend through the one or both sections 24, 25 to receive & tether- Extensions 21 extend outward from the first and second sections 24, 25, in the embodiments illustrated, the extensions 21 extend ltom an interior portion of the sections 24, 25, although other positions along the sections 24, 25 are also contemplated.
  • Extensions 21 may be fixedly attached to the sections 24, 25 such that rotation, of the extensions causes the mount 22 to aiso rotate,
  • the extensions 2 ⁇ are raovabiy connected to the sections 24, 25 and rotate independently from the sections.
  • anchors 40 attach the extensions 21 to the sacrum 102, ⁇ n this embodiment, anchors 40 are multi-axial devices com prising a saddle 43 that includes a channel 44 for receiving extensions 21.
  • a threaded fastener (not illustrated) extends into an opening in the bottom of the channel 44. The connection between the fastener and saddle 43 provides for rotational movement of the saddle 43 to accommodate the extensions 21 at a variety of orientations.
  • extensions 21 have a circular cross-sectional shape that movably fits within the channel 44.
  • Implant 50 is an interspirsous device sized to extend between the L5 spinous process 103 and the mount 22.
  • One embodiment is illustrated in Figure 7 and includes an interspinous section 51 and outwardly-extending arms 52. Inlets 53 are formed by the extensions 52 on each side of the interspinous section 51.
  • an inferior surface of the interspinous section 51 contacts the bearing face 26 and a superior surface contacts the L5 spinous process 103.
  • the inner edges of arms 52 may contact the first, and second sections 24, 25 providing lateral support to the implant 50.
  • the height H of the bearing face 26 is greater than a height h of the implant 50.
  • Implant 50 is constructed of a .flexible material to dampen the relative movements during flexion and extension.
  • Implant embodiments are disclosed in U.S..Patent Application Publication 2005/026176S and U.S. Patent No. 6,626,944 both herein incorporated by reference in their entirety.
  • Another implant embodiment is the DIAM spina! stabilization device available from Medtronic Sofamor Danek of Memphis, Tennessee. in. use, the base 20 is mounted to the sacrum '102. Initially, an incision is made to access the sacrum 102 and L5 vertebrae 10.
  • L the surface of the sacrum 102 including the sacral spinous process 105 is contoured such that the base 20 can be securely positioned on the sacrum 102. This may include contouring the superior surface of the spinous process " 105 to reduce the height, or contouring a section of the medial sacral crest ⁇ n another embodiment, base 20 is positioned on. the sacrum 102 without contouring.
  • the base 20 is positioned with the mount 22 extending outward ⁇ « a posterior direction from the sacrum 102.
  • the recess 31 is positioned to extend at least partially over the sacral spinous process 1.05.
  • the bearing face 26 is positioned superiorly of the spinous process 105 and adjacent to the L5 spinous process 103.
  • the mount 22 has a height H to extend beyond the spinous process 103 to provide a support for the Implant 50. As illustrated in Figures 1 and 2, the notch 29 on die inferior edge of the mount 22 may extend over the spinous process 1.05 and the Hp 28 aligns with the sacral lamina.
  • extensions 21 have a length to position the shaft 42 within the lamina, pedicles ⁇ sacral ala, or iliac crest of the sacrum 102,
  • interspinous implant. 50 is inserted between the mount 22 and L5 spinous process 103.
  • the inferior surface of the anteriorspirious section 5 ⁇ contacts the bearing face 26 and a superior surface faces the L5 spinous process 103.
  • the superior surface contacts the L5 spinous process 103.
  • the inner edges of arms 52 may contact the first and second sections 24, 25 and the lateral edges of the spinous process 103 providing lateral support to the implant 50.
  • a tether (not illustrated) may be used io more securely attach the implant 50 in position.
  • Tether is attached to one or more of the apertures 30 within the mount 22, and may further extend around the spinous process 103 to maintain the implant within the interspinous space formed between the mount and LS spinous process J 03.
  • the superior surface contacts the L5 spinous process 103.
  • the LS spinous process 103 has been replaced with an implant.
  • the superior surface contacts the implant.
  • the embodiments of the base 20 discussed above disclose the mount 22 and extensions 21 constructed in a unitary manner.
  • Another embodiment features a modular design as illustrated in Figures 8 and 9 having a mount 22 that is detachable from the extensions 21 ,
  • Mount 22 includes a hook 32 extending from an inferior section that. Forms a receiving area 33 sized to accommodate the extensions 21,
  • Mount 22 further includes a superior bearing face 26 and lateral first and second sections 24, 25.
  • Mount 22 may further extend outward from a base 34.
  • Extension.21 has a shape to fit within the receiving area 33.
  • the mount 22 may be movable along the extension 21 in the direction indicated by arrows A to position the mount 22 and accommodate differing anatomies between patients.
  • a lock mechanism (not illustrated) may be associated with the mount 22 and/or extension 21 to prevent further movement once proper positioning is obtained.
  • Anchors 40 attach the extension 21 to sacrum 102 as previously discussed.
  • Figures 10 and H illustrate another embodiment of the base 20 having a mount 22 positioned between extensions 21.
  • Mount 22 includes a superior bearing face 26 having a width to support the implant 50.
  • a slot 38 extends through the mount 22 between first and second sections 24, 25.
  • Each extension 21 Includes a platform.36 having an enlarged surface that aligns with a first and second section 24, 25 respectively.
  • a member 37 extends between the platforms 36 and through the slot 3 S to attach the mount 22 to the extensions 21 ,
  • Mount 22 is vertically movable relative to the extensions 21 as indicated by arrows B. The extent of adjustment is controlled by the length of the slot 38,
  • Slot 38 may further have a width to adjust a height, of the mount in a posterior direction. Once the proper positioning is obtained, member 37 may be locked to prevent further movement.
  • anchors 40 attach the base 20 to the sacrum 102.
  • mount 22 extends posteriorly beyond the height of the sacral spinous process 105.
  • the mount may extend over part or an entirety of the spinous process J 05.
  • mount 22 includes a bearing face 26 positioned on a superior face of the spinous process 105.
  • all or a portion of the spinous process 105 is removed during contouring prior to attachment of the base 20.
  • base 20 is mounted to the sacrum 102 at a point relative to the S ⁇ vertebrae. 1 « another embodiment, base 20 is mounted to the sacrum 102 relative to another vertebrae, such as the S2 vertebrae.
  • implant 50 has a greater length to extend between the L5 spinous process .103 and the bearing face 26 at. the S2 vertebrae.
  • Implants 50 may have a variety of shapes depending upon the context of usage. In one embodiment, a. mid-line of the bearing face 26 is equally distanced between the extensions 21. ⁇ n one embodiment, a single extension 21 extends from the mount 22. In one embodiment, the S 1 spinous process has an initial height prior to mounting the device. The mount 22 has a height greater than the initial height.

Abstract

Devices and methods for attaching a support to the sacrum. One device may include first and second anchors (40) that mount to the sacrum, and first and second lateral extensions (21) coupled to the anchors to secure the device to the sacrum. A bearing face (26) having a width (W) is positioned between the lateral extensions. The face may have a height (H) in an anterior-posterior direction greater than the spinous process of the sacrum. Further, the bearing face may be oriented in a superior direction when the device is mounted to the sacrum. An implant (50) may be supported by the device to space the sacrum and L5 vertebrae. The implant may be an interspinous device and positioned between the L5 spinous process and the bearing face. The implant is supported at least in part by the bearing face.

Description

ARTIFICIAL SPINOUS PROCESS FOR TJHE SACRUM: AMD METHODS OF USE
Background
The present application is directed to devices to mount with the sacrum, and more specifically to devices that attach to the sacrum and provide a support for positioning an implant between the sacrum and fifth lumbar vertebrae.
The spine is divided into regions that include the cervical, thoracic, lumbar, mά sacrococcygeal regions. The cervical region includes the top seven vertebrae identified as Cl -C7. The thoracic region includes the next twelve vertebrae . idea titled as Tl -Tl 2. The lumbar region includes five vertebrae L1-L5. The sacrococcygeal region includes nine fused vertebrae comprising the sacrum comprising S.1-S5 vertebrae and four or five rudimentary members that form the coccyx.
The sacrum is shaped like an inverted triangle with the base at the top. The sacrum acts as a wedge between the two iliac hones of the pelvis and transmits the axial loading- forces of the spine to the pelvis and lower extremities. Hie sacrum Is rotated anteriorly with the superior endplate of the S 1 vertebrae angled from about 30 to about 60 degrees in the horizontal plane.
The Sl vertebrae includes a spinous process aligned along a rϊdge called the medial sacral crest. However, the spinous process on the S 1 vertebrae may not be well defined and therefore not adequate for supporting an implant. One example of this dilemma is the inability of the spinous process to adequately support an interspinous process implant positioned between the L5 and. Si spinous processes. Summary'
The present application is directed to devices that mount to the sacrum and methods of use. One embodiment of the device may include first aad second anchors that mount to the sacrum, and first and second lateral extensions coupled to the anchors to secure the device to the sacrum. A bearing face having a width is positioned between the lateral extensions. The face may have a height in ati anterior-posterior direction greater than the spinous process of the sacrum. Further, the bearing face may be oriented in a superior direction when the device is mounted to the sacrum.
Am implant may be supported by the device to space the sacrum a«d LS vertebrae. The implant may be an interspinous device and positioned between the L5 spinous process &nά the bearing face. The implant is supported at least in part, on the bearing face.
Brief Description of the Drawings
Figure 1 is a rear view of a system having a base and an implant according to one embodiment
Figure 2 Is a top view of the base fastened to the sacrum according to one embodiment.
Figure 3 is a perspective view illustrating an inferior portion of a base according to one embodiment.
Figure 4 is a perspective view illustrating a superior portion of a base according to one embodiment.
Figure 5 Is a perspective view of a base fastened to the sacrum by a pair of anchors according to one embodiment
Figure 6 is a perspective view illustrating a superior portion of a base according to one embodiment- Figure 7 is a perspective view of an implant according to one embodiment.
Figure 8 is a side view of a mount according to one embodiment.
Figure 9 is a perspective view of a base according to one embodiment.
Figure 10 Ls a top view of a base according to one embodiment.
Figure 11 is a perspective view of a base according to one embodiment. Detailed Description
The present application is directed to a base that, attaches to the $acmm and includes a. bearing face to support an implant Figure 1 illustrates one embodiment having a base 20 that attaches to the sacrum ΪQ2> A mount.22 extends posteriorly outward from the base 20 and is sized to contact an inferior portion of an implant 50. The implant 50 extends between the mount 22 and the spinous process 103 of the L5 vertebrae 101. The base 20 includes the mount 22 and one or more extensions 21 as illustrated in Figures 2, 3, and 4. Mount 22 includes a bearing face 26 that faces m a superior direction when the base 20 is mounted to the sacrum 102. Bearing face 26 has a. height H and width W to support, the implant 50. The bearing face 26 has a height H in an anterior-posterior direction to extend posteriorly outward from the sacreim 102 a distance to support the implant 50, In one embodiment, the height H is greater than a height of Che sacral spinous process 105. Ih one embodiment; the width W of the bearing face 26 is substantially constant along the height H. In another embodiment, the width W varies along the height H. Bearing face 26 may extend outward from the sacrum 102 at a variety of angles, In one embodiment the width W of the bearing face 26 is substantially equal to a width of the L5 spinous process 103. Bearing surface 26 may be substantially planar, substantially curved, or include a combination having planar and curved sections.
Mount 22 further includes first and second sections 24, 25 that extend from the bearing face 26. Sections 24, 25 are positioned along lateral sides of the sacral spinous process 105 when the base 20 is mounted to the sacrum 102. Sections 24, 26 may have a length to extend outward and contact the sacrum 102, or may have a lesser length
Figure imgf000005_0001
be spaced from the sacrum 102 when tire base 20 is mounted. An intermediate section 49 may extend inferiorly from the bearing face 26. Intermediate section 49 may have a width to extend between the first and second sections 24, 25. A recess 31. is formed on an underside of the mount 22 and is sized to extend over the entirety or a portion of the sacral spinous process 105. The embodiments of Figures 2, 3. and 4 illustrate the sections 24, 25> 26S 49 being substantially flat and connected together along ridges. Another embodiment features the sections 24, 25, 26, 49 formed of a continuous curved member with the sections not clearly definable by ridge lines. Apertures 30 may extend through the first and second sections 24, 25 for receiving a tether as will be described Ln more detail below, Apertures 30 may also be used for grasping the base 20 during insertion and positioning into the patient.
A superior edge of the bearing face 26 may include a Up 28 as illustrated in Figure 2, Lip 28 aligns the mount 22 on the sacrum 102, and specifically aligns the mount 22 on the sacral lamina. In one embodiment, the height. H of the bearing surface includes the Hp 28. In one embodiment, the height H excludes the lip 28. Lip 28 may have the same width as the bearing face width "W, or a different width. As illustrated in Figures I and 3, a notch 29 may be formed in an inferior edge of the intermediate section 49, Notch 29 is sized to accommodate the SI spinous process .105 of the sacrum 102. In one embodiment, the lip 28 and notch 29 are centered about, a centerline of the bearing face 26. ϊn one embodiment, the centerline of the bearing face 26 is aligned with the medial sacral crest. One or .more extensions 21 extend outward from the mount 22 to contact the face of the sacrum 102. Extensions 21 may include one or more apertures 23 to receive ati anchor 40 to connect the base 20 to the sacrum. In one embodiment as illustrated Ln Figure 2, extensions 21 have a length to position the apertures 23 at the sacrum pedicles for good fastener fixation. In one embodiment, anchors 40 comprise ahead 41 that contacts the edges of the aperture 23 &nd a shaft 42 that extends into the sacrum 102. ϊn one embodiment as illustrated in Figure i „ extensions 21 have a superior edge that is substantially aligned with, the superior edge of the bearing face 26.
Figures 5 and.6 illustrate another embodiment of a base 20 comprising a mount 22 atid extensions 21. For clarity., Figure 5 does not include an implant 50.mounted between the L5 spinous process 103 and the mount 22. Mount 22 comprises first and second sections 24, 25 that connect together at a superior face thai forms the bearing face 26. Bearing face 26 is positioned at the apex of the sections 24, 25 and is positioned on the superior face of the sacral spinous process 105. Bearing face 26 has a height H to extend outward from the sacrum 102 beyond the posterior edge of the sacral spinous process 105. Sections 24, 25 extend iiiferiorly outward from the bearing face 26 and are positioned along lateral edges of the spinous process 105. The sections 24, 25 further angle laterally outward in an inferior direction giving the mount 22 a substantially V-shape. ϊn one embodiment; a height of the sections 24, 25 may be substantially equal to the height of the bearing face 26 as illustrated in Figure 5. Bearing face 26 and sections 24, 25 form a recess 31 sized to fit over the spinous process ] 05. One or .more apertures 30 may extend through the one or both sections 24, 25 to receive & tether- Extensions 21 extend outward from the first and second sections 24, 25, in the embodiments illustrated, the extensions 21 extend ltom an interior portion of the sections 24, 25, although other positions along the sections 24, 25 are also contemplated. Extensions 21 may be fixedly attached to the sections 24, 25 such that rotation, of the extensions causes the mount 22 to aiso rotate, In another embodiment, the extensions 2 \ are raovabiy connected to the sections 24, 25 and rotate independently from the sections. One or more anchors 40 attach the extensions 21 to the sacrum 102, ϊn this embodiment, anchors 40 are multi-axial devices com prising a saddle 43 that includes a channel 44 for receiving extensions 21. A threaded fastener (not illustrated) extends into an opening in the bottom of the channel 44. The connection between the fastener and saddle 43 provides for rotational movement of the saddle 43 to accommodate the extensions 21 at a variety of orientations. In one embodiment, extensions 21 have a circular cross-sectional shape that movably fits within the channel 44. The inner edges of the saddle 43 are threaded to receive a locking fastener (not illustrated) that extends over and locks the extensions 21 within the channel 44. A similar type of rotatable saddle connection Is disclosed in U.S. Patent Application Serial No. 10/870^504 titled "Orthopedic Fixation System and Method of Use" filed, on Juaie 17, 2004, the relevant sections herein incorporated by reference.
Implant 50 is an interspirsous device sized to extend between the L5 spinous process 103 and the mount 22. One embodiment is illustrated in Figure 7 and includes an interspinous section 51 and outwardly-extending arms 52. Inlets 53 are formed by the extensions 52 on each side of the interspinous section 51. In one embodiment, an inferior surface of the interspinous section 51 contacts the bearing face 26 and a superior surface contacts the L5 spinous process 103. The inner edges of arms 52 may contact the first, and second sections 24, 25 providing lateral support to the implant 50. In one embodiment, the height H of the bearing face 26 is greater than a height h of the implant 50. Implant 50 is constructed of a .flexible material to dampen the relative movements during flexion and extension. Implant embodiments are disclosed in U.S..Patent Application Publication 2005/026176S and U.S. Patent No. 6,626,944 both herein incorporated by reference in their entirety. Another implant embodiment is the DIAM spina! stabilization device available from Medtronic Sofamor Danek of Memphis, Tennessee. in. use, the base 20 is mounted to the sacrum '102. Initially, an incision is made to access the sacrum 102 and L5 vertebrae 10. L In one embodiments the surface of the sacrum 102 including the sacral spinous process 105 is contoured such that the base 20 can be securely positioned on the sacrum 102. This may include contouring the superior surface of the spinous process "105 to reduce the height, or contouring a section of the medial sacral crest ϊn another embodiment, base 20 is positioned on. the sacrum 102 without contouring.
The base 20 is positioned with the mount 22 extending outward ϊ« a posterior direction from the sacrum 102. The recess 31 is positioned to extend at least partially over the sacral spinous process 1.05. The bearing face 26 is positioned superiorly of the spinous process 105 and adjacent to the L5 spinous process 103. The mount 22 has a height H to extend beyond the spinous process 103 to provide a support for the Implant 50. As illustrated in Figures 1 and 2, the notch 29 on die inferior edge of the mount 22 may extend over the spinous process 1.05 and the Hp 28 aligns with the sacral lamina. Once the mount 22 is situated over the sacral spinous process 105, anchors 40 connect the extensions 2i to the sacrum 102. One or more fasteners extend into the sacrum 102 to securely connect the base 20. In some embodiments, extensions 21 have a length to position the shaft 42 within the lamina, pedicles^ sacral ala, or iliac crest of the sacrum 102,
Once the base 20 is mounted to the sacrum 102, interspinous implant. 50 is inserted between the mount 22 and L5 spinous process 103. The inferior surface of the iriterspirious section 5 \ contacts the bearing face 26 and a superior surface faces the L5 spinous process 103. In one embodiment, the superior surface contacts the L5 spinous process 103. The inner edges of arms 52 may contact the first and second sections 24, 25 and the lateral edges of the spinous process 103 providing lateral support to the implant 50. A tether (not illustrated) may be used io more securely attach the implant 50 in position. Tether is attached to one or more of the apertures 30 within the mount 22, and may further extend around the spinous process 103 to maintain the implant within the interspinous space formed between the mount and LS spinous process J 03. hi one embodiment, the superior surface contacts the L5 spinous process 103. In another embodiment, the LS spinous process 103 has been replaced with an implant. In this embodiment, the superior surface contacts the implant.
The embodiments of the base 20 discussed above disclose the mount 22 and extensions 21 constructed in a unitary manner. Another embodiment features a modular design as illustrated in Figures 8 and 9 having a mount 22 that is detachable from the extensions 21 , Mount 22 includes a hook 32 extending from an inferior section that. Forms a receiving area 33 sized to accommodate the extensions 21, Mount 22 further includes a superior bearing face 26 and lateral first and second sections 24, 25. Mount 22 may further extend outward from a base 34. Extension.21 has a shape to fit within the receiving area 33. The mount 22 may be movable along the extension 21 in the direction indicated by arrows A to position the mount 22 and accommodate differing anatomies between patients. A lock mechanism (not illustrated) may be associated with the mount 22 and/or extension 21 to prevent further movement once proper positioning is obtained. Anchors 40 attach the extension 21 to sacrum 102 as previously discussed.
Figures 10 and H illustrate another embodiment of the base 20 having a mount 22 positioned between extensions 21. Mount 22 includes a superior bearing face 26 having a width to support the implant 50. A slot 38 extends through the mount 22 between first and second sections 24, 25. Each extension 21 Includes a platform.36 having an enlarged surface that aligns with a first and second section 24, 25 respectively. A member 37 extends between the platforms 36 and through the slot 3 S to attach the mount 22 to the extensions 21 , Mount 22 is vertically movable relative to the extensions 21 as indicated by arrows B. The extent of adjustment is controlled by the length of the slot 38,
Movement of the mount 22 along the length of the slot 38 adjusts a distance between the bearing face 26 and the L5 spinous process 103. Slot 38 may further have a width to adjust a height, of the mount in a posterior direction. Once the proper positioning is obtained, member 37 may be locked to prevent further movement. As with the other embodiments, anchors 40 attach the base 20 to the sacrum 102.
In one embodiment, mount 22 extends posteriorly beyond the height of the sacral spinous process 105. The mount may extend over part or an entirety of the spinous process J 05. In another embodiment, mount 22 includes a bearing face 26 positioned on a superior face of the spinous process 105. M another embodiment, all or a portion of the spinous process 105 is removed during contouring prior to attachment of the base 20. ϊ.a one embodiment as illustrated in .Fi gyre 1, base 20 is mounted to the sacrum 102 at a point relative to the Sϊ vertebrae. 1« another embodiment, base 20 is mounted to the sacrum 102 relative to another vertebrae, such as the S2 vertebrae. In this embodiment, implant 50 has a greater length to extend between the L5 spinous process .103 and the bearing face 26 at. the S2 vertebrae.
Spatially relative terms such as "under", "below", "lower", "over", "upper", and the like, are used for ease of description to explain the positioning of one element relative to a second element, or relative to the anatomical elements of a patient. These terms are intended to encompass different orientations of the device in addition to different orientations than those depicted in the figures. Further, terms such as "first" , ^second", and the like, are also used to describe various elements, regions, sections, etc and are also not intended to be limiting, Like numbers refer to like elements throughout.
The present invention may be carried out m other specific ways than those herein set forth without departing from the scope and essential characteristics of the invention. Implants 50 may have a variety of shapes depending upon the context of usage. In one embodiment, a. mid-line of the bearing face 26 is equally distanced between the extensions 21. ϊn one embodiment, a single extension 21 extends from the mount 22. In one embodiment, the S 1 spinous process has an initial height prior to mounting the device. The mount 22 has a height greater than the initial height. The present embodiments are., therefore, to be considered in all respects as illustrative and not restrictive, and all changes coming within the meaning and equivalency range of the appended claims are intended to be embraced therein.

Claims

Cl AimsWhat ϊs claimed is:
1. A device to provide an inferior support for an mterspiiious implant between an L5 vertebrae and a spinous process of a sacrum, the device comprising; first and second anchors mounted to the sacrum; first and second lateral extensions coupled to the anchors to secure the device to the sacrum; and a bearing face extending between the lateral extensions, the face having a height in. an anterior-posterior direction greater than the spinous process of the sacrum and oriented in a superior direction when the device is mounted to the sacrum, to support the interspinous implant.
2. The device of claim 1 , wherein a width of the bearing face is substantially constant along the height
3. The device of claim 1, further comprising first and second faces positioned between the bearing face and the first arid second extensions, the first sad second faces and the bearing face forming an enclosure to partially cover the spinous process.
4. The device of claim 1, wherein the bearing face is fixedly connected to the first and second extensions,
5. The device of claim 1, wherein the bearing face is movably connected to the first and second extensions.
6. The device of claim 1 > further comprising .first, and second faces positioned between the bearing face and the first and second extensions, the first and second faces connecting together at the bearing face to form a V-shape.
7. The device of claim I, wherein a mid-line of the bearing face is equally distanced between the first and second lateral extensions.
S. A device to provide an .inferior support for an ktterspinous implant between an. L5 and Sl vertebra, the device comprising: first and second extensions sized to extend along a posterior face of the Sl vertebrae, the first extension positioned on & first lateral side of a Sl spinous process and the second extension positioned on a second lateral side of the Sl spinous process when the device is mounted to the Sl vertebrae; and a mount extending between the lateral extensions and having a bearing face positioned superior to the SI spinous process and extending outward in a posterior direction beyond the Sl spinous process when the device is mounted to the Sl vertebrae to support the interspinous implant.
9. The device of claim S, wherein the mount further comprises lateral sidevvalls extending from the bearing face in an inferior direction when the device is mounted to the Sl vertebrae to extend along lateral sides of the spinous process.
10. The device of claim 8, wherein the bearing face has a substantially constant width along a height of the face.
11. The device of claim 8, further comprising first and second faces positioned between the bearing face and the first and second extensions, the first and second faces and the bearing face forming an enclosure to partially cover the Sl spinous process.
12. The device of claim S, wherein the mount is sized to extend, beyond an initial height of the S.! spinous process.
π. A device to provide an inferior support for an. inter spinous implant between an L 5 vertebrae and a spinous process of a sacrum, the device comprising: first and second anchors; first and second lateral extensions coupled to the anchors to secure the device to the sacrum; and I i a mount disposed between the extensions and having a recess to receive the spinous process, the mount including a superior bearing face to support the mtersprnous implant.
14. The device of claim 13, wherein the mount is substantially V-shaped with first, and second sidewalls extending along lateral sides of the spinous process and the bearing face positioned at an apex of the sϊdewails and extending along a superior side of the spinous process when the device is attached to the sacrum.
15. The device of claim 13, further comprising an aperture positioned within the mount to receive a tether to secure the device to the sacrum.
16. The device of claim 13, wherein a midpoint of the bearing face is equally distanced between the first and. second lateral extensions.
17. The device of claim 13, wherein the recess has anterior and posterior surfaces, the anterior surface defining an underside recess to receive the spinous process, the posterior surface including the superior bearing face disposed superior to the recess.
18. A system to space apart an L5 vertebrae and a sacrum, the system, comprising; a support member that attaches to the sacrum comprising a bearing face that aligns with a midline of the sacrum and having a height, to extend posteriorly outward from the sacrum; arid an interspinous implant sized to extend between the L5 vertebrae and the sacrum, the interspiuous implant having a first surface that contacts the bearing face of the support member and a second surface that faces, ao inferior surface of the L5 vertebrae.
19. The system of claim .18, wherein the support member further comprises lateral extensions connected with the bearing face and configured to receive anchors to attach the support member to the sacrum.
20. The system of claim IS, wherein the interspinals implant further includes first and second extensions that extend outward beyond the .first surface, the first extension contacting a first sidewall of the mterspinous implant and the second extension contacting a second sidewall of the mterspiuous .implant
21. The system of claim ϊ 8, wherein the implant has a smaller width than the bearing face.
22. The system of claim 18, wherein the mterspmoυs implant is sized to contact the L5 vertebrae and the support member, the first surface contacts the bearing face of the support, member and the second surface contacts the inferior surface of the spinous process of the LS vertebrae.
23. A system to space apart an L5 vertebrae and a sacrum, the system comprising: a base having a mount aiϊd an extension, the mount having a bearing face having a height in a posterior direction greater than the spinous process of the sacrum and oriented in a superior direction when the device is mounted to the sacrum, the extension extending from a lateral side of the mount and configured to receive an anchor to secure the base to the sacrum; and an iaterspinous implant having a first surface that contacts the bearing face and a second surface that contacts a spinous process of theL5 vertebrae, a width of the interspinous implant, being less than the bearing face.
24. The device of claim 23, wherein a width of the bearing face is substantially constant along the height.
25. The device of claim 23, .further comprising a face positioned between the bearing face and the extension, the face and the bearing face forming an enclosure to partially cover the spinous process of the sacrum.
26. The device of claim 23, wherein the bearing face Is fixedly connected to the extension.
27. The device of claim 23, wherein the beating face is movabiy connected to the extension.
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