WO2007101006A1 - Prosthetic assembly for supporting a spinous process and method of implanting same - Google Patents

Prosthetic assembly for supporting a spinous process and method of implanting same Download PDF

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Publication number
WO2007101006A1
WO2007101006A1 PCT/US2007/062405 US2007062405W WO2007101006A1 WO 2007101006 A1 WO2007101006 A1 WO 2007101006A1 US 2007062405 W US2007062405 W US 2007062405W WO 2007101006 A1 WO2007101006 A1 WO 2007101006A1
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WO
WIPO (PCT)
Prior art keywords
vertebrae
adapter
assembly
spacer
rod
Prior art date
Application number
PCT/US2007/062405
Other languages
French (fr)
Inventor
Aurelien Bruneau
Thomas Carls
Eric C. Lange
Fred H. Molz, Iv
Matthew M. Morrison
Jonathan Dewey
Kent M. Anderson
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.
Priority to EP07757198A priority Critical patent/EP1988840A1/en
Publication of WO2007101006A1 publication Critical patent/WO2007101006A1/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
    • A61B17/7062Devices 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
    • 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
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7032Screws or hooks with U-shaped head or back through which longitudinal rods pass
    • 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
    • A61B17/7049Connectors, not bearing on the vertebrae, for linking longitudinal elements together

Definitions

  • the present invention relates to an intervertebral prosthetic assembly for stabilizing the human spine, and a method of implanting same.
  • Intervertebral discs that extend between adjacent vertebrae in vertebral columns of the human body provide critical support between the adjacent vertebrae while permitting multiple degress of motion. These discs can rupture, degenerate, and/or protrude by injury, degradation , disease, or the like to such a degree that the intervertebral space between adjacent vertebrae collapses as the disc loses at least a part of its support function, which can cause impingement of the nerve roots and severe pain.
  • Intervertebral prosthetic devices have b ⁇ w. designed that can he implanted between the adjacent vertebrae, both anterior and posterior of the column. Many of these devices are supported between the spinous processes of the adjacent vertebrae Io prevent the collapse of the intervertebral space between the adjacent vertebrae and provide motion stabilization of the spine.
  • a spinous process from one of the vertebrae il would be impossible to implant an intervertebral prosthetic device of the above type since the device requires support from the respective spinous processes of both adjacent vertebrae.
  • an intervertebral prosthetic assembly is provided that is implantable between two adjacent vertebrae to provide motion, stabilization, despite the fact that at least one of vertebrae is void of a spinous process.
  • Fig. 1 is a side elevational view of an adult human vertebral column.
  • Fig. 2 is a posterior elevational view of the column of Fig. 1.
  • Fig. 3 is an enlarged, front elevational view of one of the vertebrae of the column of Figs. 1 and 2.
  • Fig. 4 is an isometric view of a portion, of the column of Figs. 1 and 2, including the lower three vertebrae of the column, and depicting an intervertebral prosthetic assembly according to an embodiment of the invention implanted between two adjacent vertebrae.
  • Fig. 5 is an enlarged view of a portion of the column and the assembly shown in Fig. 4_
  • Fig. 6 is an enlarged isometric view of a component of the assembly of Figs. 4 and 5.
  • Figs.7-9 are enlarged, isometric views of three alternate embodiments of the component of Fig. 6.
  • Fig. 1 C) is a view similar to that of Fig. 5, hut depicting an alternate embodiment of the invention.
  • the reference numeral iO refers, in general * to a human vertebral column 10.
  • the lower portion of the vertebral column 10 is shown and includes the lumbar region 12, the sacrum .14, and the coccyx 16.
  • the lumbar region 12 of the vertebral column H) includes five vertebrae Vl. V2, V3 « V4 and V5 separated by intervertebral discs DL D.2, D3, and D4, with the disc Dl extending between the vertebrae V 1 and V2, the disc D2 extending between the vertebrae V2 and V3, the disc D3 extending between the vertebrae V3 and V4, and the disc D4 extending between the vertebrae V4 and. V5.
  • the vertebrae V6 includes five fused vertebrae, one of which is a superior vertebrae V6 separated from the vertebrae V5 by a disc D5. Tlte other four fused vertebrae of the sacrum .14 are referred to collect* vely as V7.
  • a disc D6 separates the vertebrae V6 from the coccyx 16 that includes four fused vertebrae (not referenced).
  • the vertebrae V5 includes two laminae 20a and 20b extending to either side (as viewed, in Fig. 2) of a spinous process 22 that projects posteriorly from the juncture of the two laminae.
  • Two transverse processes Two transverse processes
  • V .1 -V3 are similar to the vertebrae V5 S they will not be described in detail.
  • V4 is similar to V5 with the exception that the spinous process 22 of V4 has been removed for one or both of the reasons set forth above.
  • two spaced, parallel, flexible rods 30 and 32 are provided that generally span the axial length between the processes 22 of the vertebrae V4 and YS.
  • Two axially-spaeed screw retainers 34a and 34b are connected Io the rod 30 and two asi ally-spaced screw retainers 34c and Md. are connected to the rod 32.
  • the screw retainers 34a, 34b, 34c ; and 34d retain pedicle screws 38a, 38b, 38c. and 38d respectively, each of which extends through, and is supported by, its corresponding retainer.
  • the screws 38a and 38c extend into the pedicles of the vertebrae V4, and t he s crews 38b and 38d extend into the pedicles of the vertebrae V5. It is understood that the rods 30 and 32, the retainers 34a-34d atid the screws 38a-3$d are installed in connection with the procedure to be described, or that they could have been previously installed in connection with another procedure.
  • a spacer 40 is provided that is fabricated from a relatively flexible, soft material, and is substantially rectangular in shape with the exception that two curved notches, or saddles . , 40a and 40b are termed at its respective end portions.
  • the notch 40a extends around the spinous process 22 of the vertebrae V3. and, since the spinous process of the vertebrae V4 has been removed, an adapter 44, shown in detail in Fig. 7 t is provided for supporting the spacer 40,
  • the adapter 44 comprises a. rectangularly-shaped body member 44a that is sized so as to extend in the notch 40a of the spacer 40.
  • Two arms 44b and 44c extend from the body member and can be formed integrally with, or attached to r the body member 44a.
  • the respective distal end portions of the 44abrm ansd 44c curve downwardly from the body member as viewed in Fig.7, and their respective distal end. portions are curved inwardly so as Xo fit over the rods 30 and 32 (Fig, S).
  • the adapter 44 is fabricated from a relatively stiff materia! . , such as hard rubber or plastic.
  • the adapter 44 can be moved axially up or down the vertebral column 10 as necessary by moving the ar 4m4bs and 44c along the rods 30 and 32, to insure that the spacer 40 fits between the spinous process 22 of the vertebrae V3 and the body .member 44a of the adapter.
  • the assembly consisting of the rods 30 and 32 ? the spacer 40 and the adapter 44 stabilizes the vertebrae V3 and V4. Also, the relatively flexible, soft spacer 40 readily conforms to the processes 22 of the vertebrae V3 and provides excellent defomiability resulting in an improved fit.
  • the adapter 44 adds stifrness, compressive strength and An alternate embodiment of an adapter is shown, in general, by the reference numeral 50 in Fig. 8, The adapter 50 composes a rectangularly -shaped body member 52 hax ing a, tab 52a extending LYom one end thereof. Two through-openings are provided in the tab 52a that receive two arms 56a and 56b.
  • the arm 5s6a and 56b thus extend laterally from the b ⁇ d> member 52. with their respective distal end portions being curved inwardly.
  • the arms 56a and 56b extend in the openings m the tab 52a in a friction fit and therefore can be adjusted laterally by moving them axially in the openings
  • the angular position of the arms 56a and 56h rel ati ⁇ e to the body member 52 can be adjusted by rotating the arm isn the openings in the tab 52a.
  • ⁇ f necessary, set screws t ⁇ oi shown), or the like, could be pro ⁇ ided through additional openings in the lab 52a to lock the arms 56a and 56b m a desired axial and angular position Preferabh .
  • the adapter 50 is fabricated from a relatively stiff material, such as hard rubber or plastic.
  • the implanted position shown in Fig. 5 the spinous process 22 of the vertebrae V3 extends in the notch 40b of the spacer 40. and the body membei 52 extends m the notch 40a.
  • the effects ⁇ e lengths of the arms 56a ami 56b can be adjusted so that their respective curved distal end portions extend over the rods 30 and 32, respectively.
  • Thearms 56a and 56b prevent lateral » ⁇ n ement of the adapter 50 ⁇ et permit the adapter 44 to be moved axially up or down the ⁇ ertebral column 10 by moving thearms along the rods 30 and 32.
  • the axial position of the adapter 50 can be adjusted as necessary to insure that the spacer 40 fits between the spinous process 22 of the ⁇ ertebrae V3 and the body membej 52 of the adapter.
  • the assembly consisting of tlie rods 30 and 32, the spacer 40. and the adapter 50 thus stabilizes the vertebrae V3 and V4. Also, the relatively ⁇ exibie. soft spacer 40 readily conforms to the process 22 of the ⁇ eriebrac V3 and provides excellent deformability resulting in an improved fit, while the adapter 50 adds stiffness, compressive strength and durabiiitv and the arms 56a and 56b also restrain the adapter 44 from lateral
  • Another alternate embodiment of an adapter is shown, in general, by the reference numeral 60 in Fig. 9.
  • the adapter 60 comprises a rectangularly-shaped body member 62 having a stem 62a projecting therefrom and extending in an axial opening in a bracket 64.
  • the lengths of the stem 60a and the latter opening are such that the amount of stem 60s that extends in the opening can be varied to vary the relative axial positions between the body member 62 and the bracket 64.
  • a set screw 66 extends through a lateral opening m the bracket 64 and engages the stem 60a to lock the stem, and therefore the body member 62 to the bracket 64.
  • Twoarms 66a and 66b extend laterally from the bracket 64 and preferably are formed integrally with the bracket
  • the arms 66a and 66b curve downward? as viewed in Fig. 9, with their respective distal end portions being curved inwardly so as to ⁇ t over the rods 30 and 32 (Fig. 5).
  • the arms 66a and 66b can be Conned integrally with, or attached to, the bracket 64.
  • the adapter 60 is fabricated from a relatively stiff material such as hard rubber or pi astic.
  • the spinous process 22 of the vertebrae V3 extends in the notch 40b of the spacer 40.
  • the body member 62 extends in the notch 40a. and the curved distal end portions of the arms 66a and 66b extend around the rods 30 and 32 5 respectively.
  • Thearms 66a and 66b prevent lateral movement of the adapter 60 yet permit the adapter to be moved axially up or down the vertebral column 10 by moving the arm aslong the rods 30 and 32.
  • the axial position of the adapter 60 can be adjusted as necessary to insure that the spacer 40 fits between the spinous process 22 of the vertebrae V3 and the body member 62 of. the adapter.
  • the embodiment of Fig. 10 is similar to that of Fig. 5 and includes identival components that are given the same reference numerals. According to the embodiment of Fig. 10. an adapter 70 is provided that consists of a rectangularly-shaped body member 72 that receives two arms 74a and 74b, respectively.
  • the proximal ends of the arm 7s4a and 74b are connected to, or are formed integrally with, the body member 72, and the arms extend from the body member to the retainers 34a and 34c. respectively and thus extend at an acute angle with respect to the longitudinal axis of the column 12 (Fig. 2).
  • the respective dist ⁇ .1 end portions of the arm 7s4a and 74b are connected to the screws 38a and 38c, respectively, and/or the retainers 34a and 34c, respectively in any conventional manner.
  • the adapter 70 is by positioning the spinous process 22 of the vertebrae V3 m the notch 40a of the spacer 40, and the body member 72 in the notch 42b.
  • the distal end portions of the arms 76a and.76b are fastened, to the retainers 34a and 34c. respectively to restrain the adapter 70 from lateral movement
  • the assembly consisting of the rods 30 and 32, the spacer 40, and the adapter 70 thus stabilizes the vertebrae V3 and. V4. Also, the relatively flexible, soft spacer 40 readily conforms to the process 22 of the vertebrae V3 and provides excellent deformability resulting in an improved fit, the adapter 70 adds stiffness, compressive strength and durability, and the arms 76a and 76b restrain the adapter 44 from latelal movement.
  • the arms in each of the previous embodiments can be rigidly connected to their corresponding rods by set screws, or other connection devices.
  • the components disclosed above can be fabricated from materials other than those described above and may include a combination, of soft and rigid materials.
  • the spacer in each of the above embodiments may be formed integrally with its corresponding adapter. • Any conventional substance that promotes bone growth, such as BA coating,
  • BMP BMP, or the like, can be incorporated in the above embodiments.
  • the surfaces of the spacer 40 defining the notches 40a and 42b can be treated, such as by providing teeth, ridges, knurling, etc., to belter grip the spinous processes and the adapters.
  • the spacer 40 can be fabricated of a permanently deformable material thus providing a clamping action against the spinous processes 22.
  • One or more of the components disclosed above may have through-holes formed therein to improve integration of the bone growth.
  • the components of one or more of the above embodiments may vary in shape, size, composition, and physical properties.
  • Through-openings can be provided through one or more components of each of the above embodiments to receive tethers for attaching the devices to a vertebrae or to a spinous process.
  • the assemblies of each of the above embodiments can. be placed between two vertebrae in the vertebral column 10 other than the ones described above.
  • the relatively stiff components described above could be made of a resorbable material so that their stiffness would change over time.
  • the rods 30 and 32 could be flexible or rigid.
  • the adjustment mechanism for moving the assembly consisting of the bracket 64 and the arms 66a and 66b axialiy may be on the latter assembly rather than the body member 62.
  • the arms 74a and 74b could be pivotal Iy mounted to the body member 52.
  • the assemblies of the above embodiments can be inserted between two vertebrae following a discectemy in which a disc between the adjacent vertebrae is removed, or corpectomy in which at least one vertebrae is removed.
  • the spatial references made anove, such as “under”, “over” , “between”, “flexible, soft”, “lower”, “top”, “bottom”, etc. are for the purpose of illustration only and do not limit the specific orientation or location of the structure described above.

Abstract

A prosthetic assembly and method of implanting same, according to which a least one rod is secured to the spinal column. A spacer engages the spinous process of a vertebrae of the spinal column. The rod is connected to the spacer via an adapter.

Description

INTERVERTEBRAL PROSTHETIC ASSEMBLY FOR SPINAL
STABILIZATION AND METHOD OF IMPLANTING SAME
Background
The present invention relates to an intervertebral prosthetic assembly for stabilizing the human spine, and a method of implanting same.
Intervertebral discs that extend between adjacent vertebrae in vertebral columns of the human body provide critical support between the adjacent vertebrae while permitting multiple degress of motion. These discs can rupture, degenerate, and/or protrude by injury, degradation, disease, or the like to such a degree that the intervertebral space between adjacent vertebrae collapses as the disc loses at least a part of its support function, which can cause impingement of the nerve roots and severe pain.
In some situations it is often, necessary to perform a laminectomy to remove the laminae and the spinous process from at least one vertebrae to remove i ntervertebral disc and/or to decompress a nerve root. Typically, in these procedures, two vertebra! segments are fused together to stop my motion between the segments and thus relieve the pain.
Intervertebral prosthetic devices have b^w. designed that can he implanted between the adjacent vertebrae, both anterior and posterior of the column. Many of these devices are supported between the spinous processes of the adjacent vertebrae Io prevent the collapse of the intervertebral space between the adjacent vertebrae and provide motion stabilization of the spine. However, in the above situation involving removal of a spinous process from one of the vertebrae, il would be impossible to implant an intervertebral prosthetic device of the above type since the device requires support from the respective spinous processes of both adjacent vertebrae. Summary
According to an embodiment of the invention, an intervertebral prosthetic assembly is provided that is implantable between two adjacent vertebrae to provide motion, stabilization, despite the fact that at least one of vertebrae is void of a spinous process.
Various embodiments of the invention may possess one or more of the above features and advantages, or provide one or more solutions to the above problems existing in the prior art
Brief Description of the Drawings
Fig. 1 is a side elevational view of an adult human vertebral column.
Fig. 2 is a posterior elevational view of the column of Fig. 1.
Fig. 3 is an enlarged, front elevational view of one of the vertebrae of the column of Figs. 1 and 2. Fig. 4 is an isometric view of a portion, of the column of Figs. 1 and 2, including the lower three vertebrae of the column, and depicting an intervertebral prosthetic assembly according to an embodiment of the invention implanted between two adjacent vertebrae.
Fig. 5 is an enlarged view of a portion of the column and the assembly shown in Fig. 4_
Fig. 6 is an enlarged isometric view of a component of the assembly of Figs. 4 and 5.
Figs.7-9 are enlarged, isometric views of three alternate embodiments of the component of Fig. 6. Fig. 1 C) is a view similar to that of Fig. 5, hut depicting an alternate embodiment of the invention.
Detailed Description With reference to Figs. 1 and 2, the reference numeral iO refers, in general* to a human vertebral column 10. The lower portion of the vertebral column 10 is shown and includes the lumbar region 12, the sacrum .14, and the coccyx 16. The flexible, soft portion of the vertebral column 10, which includes the thoracic region and the cervical region, is not shown.
The lumbar region 12 of the vertebral column H) includes five vertebrae Vl. V2, V3« V4 and V5 separated by intervertebral discs DL D.2, D3, and D4, with the disc Dl extending between the vertebrae V 1 and V2, the disc D2 extending between the vertebrae V2 and V3, the disc D3 extending between the vertebrae V3 and V4, and the disc D4 extending between the vertebrae V4 and. V5. The vertebrae V6 includes five fused vertebrae, one of which is a superior vertebrae V6 separated from the vertebrae V5 by a disc D5. Tlte other four fused vertebrae of the sacrum .14 are referred to collect* vely as V7. A disc D6 separates the vertebrae V6 from the coccyx 16 that includes four fused vertebrae (not referenced).
With reference to Fig. 3, the vertebrae V5 includes two laminae 20a and 20b extending to either side (as viewed, in Fig. 2) of a spinous process 22 that projects posteriorly from the juncture of the two laminae. Two transverse processes
24a and 24b extend laterally from the laminae 20a and 201% respectively, and two pedicles 26a and 26b extend anteriorly .from the processes 24a and 24b to a vertebral body 28. Since the other vertebrae V .1 -V3 are similar to the vertebrae V5S they will not be described in detail. Also, V4 is similar to V5 with the exception that the spinous process 22 of V4 has been removed for one or both of the reasons set forth above.
Refe.rr.rmi to Figs.4 and.5, it will be assumed that, for one or more of the reasons set forth above, the vertebrae V4 and V5 are not being adequately supported by the disc D4. the spinous process 22 of V4 has been removed,, and that it is desired to provide supplemental support and motion stabilization of these vertebrae.
To this end, two spaced, parallel, flexible rods 30 and 32 are provided that generally span the axial length between the processes 22 of the vertebrae V4 and YS. Two axially-spaeed screw retainers 34a and 34b are connected Io the rod 30 and two asi ally-spaced screw retainers 34c and Md. are connected to the rod 32. The screw retainers 34a, 34b, 34c; and 34d retain pedicle screws 38a, 38b, 38c. and 38d respectively, each of which extends through, and is supported by, its corresponding retainer. The screws 38a and 38c extend into the pedicles of the vertebrae V4, and t he s crews 38b and 38d extend into the pedicles of the vertebrae V5. It is understood that the rods 30 and 32, the retainers 34a-34d atid the screws 38a-3$d are installed in connection with the procedure to be described, or that they could have been previously installed in connection with another procedure.
As shown In Figs. 5 and 6. a spacer 40 is provided that is fabricated from a relatively flexible, soft material, and is substantially rectangular in shape with the exception that two curved notches, or saddles., 40a and 40b are termed at its respective end portions. The notch 40a extends around the spinous process 22 of the vertebrae V3. and, since the spinous process of the vertebrae V4 has been removed, an adapter 44, shown in detail in Fig. 7t is provided for supporting the spacer 40,
The adapter 44 comprises a. rectangularly-shaped body member 44a that is sized so as to extend in the notch 40a of the spacer 40. Two arms 44b and 44c extend from the body member and can be formed integrally with, or attached tor the body member 44a. The respective distal end portions of the 44abrm ansd 44c curve downwardly from the body member as viewed in Fig.7, and their respective distal end. portions are curved inwardly so as Xo fit over the rods 30 and 32 (Fig, S). Preferably, the adapter 44 is fabricated from a relatively stiff materia!., such as hard rubber or plastic.
The adapter 44 can be moved axially up or down the vertebral column 10 as necessary by moving the ar 4m4bs and 44c along the rods 30 and 32, to insure that the spacer 40 fits between the spinous process 22 of the vertebrae V3 and the body .member 44a of the adapter.
In its implanted position shown in Fig. 5. the assembly consisting of the rods 30 and 32? the spacer 40 and the adapter 44 stabilizes the vertebrae V3 and V4. Also, the relatively flexible, soft spacer 40 readily conforms to the processes 22 of the vertebrae V3 and provides excellent defomiability resulting in an improved fit. The adapter 44 adds stifrness, compressive strength and An alternate embodiment of an adapter is shown, in general, by the reference numeral 50 in Fig. 8, The adapter 50 composes a rectangularly -shaped body member 52 hax ing a, tab 52a extending LYom one end thereof. Two through-openings are provided in the tab 52a that receive two arms 56a and 56b. respective)} The arm 5s6a and 56b thus extend laterally from the bød> member 52. with their respective distal end portions being curved inwardly. The arms 56a and 56b extend in the openings m the tab 52a in a friction fit and therefore can be adjusted laterally by moving them axially in the openings Also, the angular position of the arms 56a and 56h rel ati \ e to the body member 52 can be adjusted by rotating the arm isn the openings in the tab 52a. ϊf necessary, set screws tøoi shown), or the like, could be pro\ ided through additional openings in the lab 52a to lock the arms 56a and 56b m a desired axial and angular position Preferabh . the adapter 50 is fabricated from a relatively stiff material, such as hard rubber or plastic.
When the adapter 50 is used in place of the adapter 44 m the implanted position shown in Fig. 5» the spinous process 22 of the vertebrae V3 extends in the notch 40b of the spacer 40. and the body membei 52 extends m the notch 40a. The effects \ e lengths of the arms 56a ami 56b can be adjusted so that their respective curved distal end portions extend over the rods 30 and 32, respectively.
Thearms 56a and 56b prevent lateral »κn ement of the adapter 50 \ et permit the adapter 44 to be moved axially up or down the \ ertebral column 10 by moving thearms along the rods 30 and 32. Thus, the axial position of the adapter 50 can be adjusted as necessary to insure that the spacer 40 fits between the spinous process 22 of the \ ertebrae V3 and the body membej 52 of the adapter.
The assembly consisting of tlie rods 30 and 32, the spacer 40. and the adapter 50 thus stabilizes the vertebrae V3 and V4. Also, the relatively ϊϊexibie. soft spacer 40 readily conforms to the process 22 of the \eriebrac V3 and provides excellent deformability resulting in an improved fit, while the adapter 50 adds stiffness, compressive strength and durabiiitv and the arms 56a and 56b also restrain the adapter 44 from lateral
Figure imgf000007_0001
Another alternate embodiment of an adapter is shown, in general, by the reference numeral 60 in Fig. 9. The adapter 60 comprises a rectangularly-shaped body member 62 having a stem 62a projecting therefrom and extending in an axial opening in a bracket 64. The lengths of the stem 60a and the latter opening are such that the amount of stem 60s that extends in the opening can be varied to vary the relative axial positions between the body member 62 and the bracket 64. A set screw 66 extends through a lateral opening m the bracket 64 and engages the stem 60a to lock the stem, and therefore the body member 62 to the bracket 64.
Twoarms 66a and 66b extend laterally from the bracket 64 and preferably are formed integrally with the bracket The arms 66a and 66b curve downward? as viewed in Fig. 9, with their respective distal end portions being curved inwardly so as to βt over the rods 30 and 32 (Fig. 5). The arms 66a and 66b can be Conned integrally with, or attached to, the bracket 64. Preferably, the adapter 60 is fabricated from a relatively stiff material such as hard rubber or pi astic.
When the adapter 60 is used in place of the adapter 44 in the implanted position shown in Fig. 5, the spinous process 22 of the vertebrae V3 extends in the notch 40b of the spacer 40. (he body member 62 extends in the notch 40a. and the curved distal end portions of the arms 66a and 66b extend around the rods 30 and 325 respectively.
Thearms 66a and 66b prevent lateral movement of the adapter 60 yet permit the adapter to be moved axially up or down the vertebral column 10 by moving the arm aslong the rods 30 and 32. Thus, the axial position of the adapter 60 can be adjusted as necessary to insure that the spacer 40 fits between the spinous process 22 of the vertebrae V3 and the body member 62 of. the adapter.
The assembly consisting of the rods 30 and 32, the spacer 40 aid the adapter 60 stabilizes the vertebrae V3 and V4. Also, the relatively flexible, soft spacer 40 readily conforms to the processes 22 of the vertebrae V3 and provides excellent deformability resulting in an improved fit, while the adapter 60 adds stiffness, compressive strength aid durability, and the arms 66a and 66b restrain the adapter 44 from lateral movement. The embodiment of Fig. 10 is similar to that of Fig. 5 and includes identival components that are given the same reference numerals. According to the embodiment of Fig. 10. an adapter 70 is provided that consists of a rectangularly-shaped body member 72 that receives two arms 74a and 74b, respectively. The proximal ends of the arm 7s4a and 74b are connected to, or are formed integrally with, the body member 72, and the arms extend from the body member to the retainers 34a and 34c. respectively and thus extend at an acute angle with respect to the longitudinal axis of the column 12 (Fig. 2). The respective distø.1 end portions of the arm 7s4a and 74b are connected to the screws 38a and 38c, respectively, and/or the retainers 34a and 34c, respectively in any conventional manner.
Assuming the spinous process 22 has been removed from the vertebrae V4 for one or more reasons set forth above, the adapter 70 is by positioning the spinous process 22 of the vertebrae V3 m the notch 40a of the spacer 40, and the body member 72 in the notch 42b. The distal end portions of the arms 76a and.76b are fastened, to the retainers 34a and 34c. respectively to restrain the adapter 70 from lateral movement
The assembly consisting of the rods 30 and 32, the spacer 40, and the adapter 70 thus stabilizes the vertebrae V3 and. V4. Also, the relatively flexible, soft spacer 40 readily conforms to the process 22 of the vertebrae V3 and provides excellent deformability resulting in an improved fit, the adapter 70 adds stiffness, compressive strength and durability, and the arms 76a and 76b restrain the adapter 44 from latelal movement.
Variations It is understood that variations may be made in the foregoing without departing from the invention and examples of some variations are as follows;
• The arms in each of the previous embodiments can be rigidly connected to their corresponding rods by set screws, or other connection devices. ♦ The components disclosed above can be fabricated from materials other than those described above and may include a combination, of soft and rigid materials.
• The spacer in each of the above embodiments may be formed integrally with its corresponding adapter. • Any conventional substance that promotes bone growth, such as BA coating,
BMP, or the like, can be incorporated in the above embodiments.
• The surfaces of the spacer 40 defining the notches 40a and 42b can be treated, such as by providing teeth, ridges, knurling, etc., to belter grip the spinous processes and the adapters.
° The spacer 40 can be fabricated of a permanently deformable material thus providing a clamping action against the spinous processes 22.
• One or more of the components disclosed above may have through-holes formed therein to improve integration of the bone growth. • The components of one or more of the above embodiments may vary in shape, size, composition, and physical properties.
• Through-openings can be provided through one or more components of each of the above embodiments to receive tethers for attaching the devices to a vertebrae or to a spinous process. * The assemblies of each of the above embodiments can. be placed between two vertebrae in the vertebral column 10 other than the ones described above.
• The number and lengths of rods and arms in one or more of the mebodiments can be varied.
• The relatively stiff components described above could be made of a resorbable material so that their stiffness would change over time.
° The rods 30 and 32 could be flexible or rigid.
• In the embodiment of Fig. 9. the adjustment mechanism for moving the assembly consisting of the bracket 64 and the arms 66a and 66b axialiy may be on the latter assembly rather than the body member 62. • In the embodiment of Fig. 10, the arms 74a and 74b could be pivotal Iy mounted to the body member 52.
• The assemblies of the above embodiments can be implanted between body portions other than vertebrae.
• The assemblies of the above embodiments can be inserted between two vertebrae following a discectemy in which a disc between the adjacent vertebrae is removed, or corpectomy in which at least one vertebrae is removed. • The spatial references made anove, such as "under", "over" , "between", "flexible, soft", "lower", "top", "bottom", etc. are for the purpose of illustration only and do not limit the specific orientation or location of the structure described above.
The preceding specific embodiments are illustrative of the practice of the invention. It is to be understood, therefore, thai other expedients known to those skilled in the art or disclosed herein, may be employed without departing from the invention or the scope of the appended claims, as detailed above. In the claims, means-plus-function clauses are intended to cover the structures described herein as performing the recited function and not only structural equivalents but also equivalent structures. Thus, although a nail and a screw may nol be structural equivalents in that anail employs a cylindrical surface to secure wooden pails together, whereas a screw employs a helical surface, in the environment of fastening wooden parts a nail and a screw are equivalent structures.

Claims

What is claimed is:
1. A prosthetic assembly for insertion in a spinal column, the device comprising: at least one rod secured to the spinal column: a spacer engaging a spinous process of a vertebrae of the spinal column; and an adapter connected to the rod and engaging the spacer,
2. The assembly of claim 1 wherein the spacer is supported between the spinous process and the adapter.
3, The assembly of claim 1 wherein the adapter comprises a body member engaging the spacer, and at least one arm extending from the body member and engaging the rod.
4. The assembly of claim 3 wherein there are two rods and two thatarms respectively engage the rods.
5. The assembly of claim 3 wherein the position of the arm relative to the body member and the rod is adjustable.
6. The assembly of claim 5 wherein the distance of the arm form the body member to the rod is adjustable.
7. The assembly of claim 5 wherein the rod is rotatablε relative to the body member and the rod.
8. The assembly of claim 1 wherein the spinal column includes an additional vertebrae adjacent the first-mentioned vertebrae, wherein the additional vertebras does not have a spinous process, and wherein the spacer and the adapter stabilize the spinal column between the two vertebrae.
9. The assembly of claim 8 wherein the rod is connected Io the two vertebrae.
.
10. The assembly of claim 9 wherein there are two rods each of which is connected to the two vertebrae, and further comprising two arms on the adapter that respectively engage the two rods.
11. The assembly of claim 8 further comprising a retainer disposed at the respectively ends of the rod and a screw extending through the retainer and into the vertebrae to connect the rod to the vertebrae.
12. The assembly of claim 11 further comprising at least one arm extending from the adapter and connected to the retainer.
13. The assembly of claim 12 wherein a opening is formed through one end portion of the arm for receiving the screw, to connect the arm to lite retainer.
14. The assembly of claim 1 wherein two notches are provided on the spacer for receiving the spinous process and the adapter, respectively.
15. The assembly of claim 1 wherein the position of the adapter relative to the spinous process, the spacer, and the rod is adjustable to insure a good fit between the spacer and. adapter.
PCT/US2007/062405 2006-02-22 2007-02-20 Prosthetic assembly for supporting a spinous process and method of implanting same WO2007101006A1 (en)

Priority Applications (1)

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US11/359,070 US20070233068A1 (en) 2006-02-22 2006-02-22 Intervertebral prosthetic assembly for spinal stabilization and method of implanting same
US11/359,070 2006-02-22

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