WO2004089260A1 - Apparatus and method for supporting vertebral bodies - Google Patents
Apparatus and method for supporting vertebral bodies Download PDFInfo
- Publication number
- WO2004089260A1 WO2004089260A1 PCT/US2004/009748 US2004009748W WO2004089260A1 WO 2004089260 A1 WO2004089260 A1 WO 2004089260A1 US 2004009748 W US2004009748 W US 2004009748W WO 2004089260 A1 WO2004089260 A1 WO 2004089260A1
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- WO
- WIPO (PCT)
- Prior art keywords
- ofthe
- end members
- members
- elongate support
- vertebral bodies
- Prior art date
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0004—Rounded shapes, e.g. with rounded corners
- A61F2230/0013—Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/0034—D-shaped
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
- A61F2250/0006—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting angular orientation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00017—Iron- or Fe-based alloys, e.g. stainless steel
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
Definitions
- the present invention generally relates to spinal implants, and more particularly relates to an apparatus and method for supporting an axial space between vertebral bodies following a vertebrectomy.
- Various portions ofthe spinal column may become displaced or damaged due to trauma, disease or aging.
- Treatment procedures may involve removal of at least a portion of one or more vertebral bodies and/or intervertebral disc tissue.
- Several techniques are cunently available for restoring and maintaining the axial space between two vertebral bodies following removal of vertebral bone and/or tissue from the area between the vertebral bodies. Restoration and support ofthe axial space is sometimes accomplished by attaching one or more plates and/or rods to outer surfaces ofthe vertebral bodies to bridge the intervertebral space.
- an implant is inserted into the intervertebral space to provide the requisite amount of axial support.
- a bone growth inducing material is sometimes introduced into the intervertebral space to facilitate the formation of a solid bony comiection between the vertebral bodies.
- previous vertebral body replacement implants include allograft, silicone tubing filled with cement, cages and other types of fusion devices or materials.
- adjustability is a feature that most of these techniques fail to provide. Subsidence into the adjacent vertebral bodies is also a drawback prevalent in previous vertebrectomy options.
- Access to a displaced or damaged portion of he spinal column may be accomplished via several approaches.
- One approach is to gain access to the anterior portion ofthe spine through the patient's chest or abdomen.
- significant morbidity may ensue and many vertebral levels are not readily accessible via an anterior approach, particularly with regard to the upper thoracic or upper lumbar vertebral levels.
- a posterior approach may also be used and provides a number of advantages, but may be associated with considerable difficulty in the reconstruction ofthe spinal column.
- the presence ofthe spinal cord and the inherent risks associated with retraction and manipulation of this structure limits access to the intervertebral space that lies anterior to the spinal cord.
- FIG. 1 is an end elevational view of a cage assembly according to one embodiment of the present invention.
- FIG. 2 is a side perspective view of an end member according to one embodiment of the present invention for use in association with the cage assembly illustrated in FIG. 1.
- FIG. 3 is a top plan view, partially in section, ofthe end member illustrated in FIG. 2.
- FIG. 4 is a side elevational view ofthe cage assembly illustrated in FIG. 1, as positioned between upper and lower vertebral bodies.
- FIG. 5 is a cross sectional view ofthe cage assembly illustrated in FIG. 4, as viewed along line 5-5 of FIG. 4.
- FIGS. 6A-6C are illustrations of a method according to one embodiment ofthe present invention for inserting the cage assembly illustrated in FIG. 1 between the upper and lower vertebral bodies using a posterior surgical approach.
- FIG. 7 is a perspective elevational view of a cage assembly according to another embodiment ofthe present invention, as positioned between upper and lower vertebral bodies and with a fibular strut augmented within an interior region ofthe cage assembly for promoting bone growth between the upper and lower vertebral bodies.
- FIG. 8 is a perspective elevational view of a cage assembly according to another embodiment ofthe present invention, as positioned between upper and lower vertebral bodies and with a hollow mesh cage member positioned within an interior region ofthe cage assembly for promoting bone growth between the upper and lower vertebral bodies.
- FIG. 9 is a perspective elevational view of a cage assembly according to another embodiment ofthe present invention, as positioned between upper and lower vertebral bodies and with graft material contained by a resorbable film positioned within an interior region of the cage assembly for promoting bone growth between the upper and lower vertebral bodies.
- FIG. 10 is a cross-sectional view ofthe cage assembly illustrated in FIG. 9.
- FIG. 11 is a side view of a distractor instrument according to one embodiment ofthe present invention for use in association with the cage assembly illustrated in FIG. 1.
- FIG. 12 is a top plan view ofthe distractor instrument illustrated in FIG. 11.
- FIG. 13a is a side elevational view ofthe distal end portions ofthe distractor instrument illustrated in FIG. 11, as engaged with the upper and lower end members ofthe cage assembly illustrated in FIG. 1 to distract the upper and lower vertebral bodies.
- FIG. 13b is a cross-sectional view ofthe distal end portions ofthe distractor instrument as engaged with the cage assembly illustrated in FIG. 13a, as viewed along line 13b-13b ofFIG. 13a.
- FIG. 14 is an exploded posterior elevational view of a cage assembly according to another embodiment ofthe present invention having a multi-axial configuration.
- FIG. 15 is a top plan view, partially in section, of a multi-axial end member according to one embodiment ofthe invention for use in association with the cage assembly illustrated in FIG. 14, as viewed along line 15-15 of FIG. 14.
- FIG. 16 is a cross sectional view ofthe multi-axial end member illustrated in FIG. 15, as viewed along line 16-16 of FIG. 15.
- FIG. 17 is an exploded posterior elevational view of a cage assembly according to another embodiment ofthe present invention having a mono-axial configuration.
- FIG. 18 is a top plan view, partially in section, of a mono-axial end member according to one embodiment ofthe invention for use in association with the cage assembly illustrated in FIG. 17, as viewed along line 18-18 of FIG. 17.
- FIG. 19 is a cross sectional view ofthe mono-axial end member illustrated in FIG. 18, as viewed along line 19-19 of FIG. 18.
- an apparatus for supporting vertebral bodies, including a first end member adapted to engage a lower endplate of a first vertebral body, a second end member adapted to engage an upper endplate of a second vertebral body, and at least one elongate support member coupled between the first and second end members to maintain an axial space between the first and second vertebral bodies.
- Each ofthe first and second end members has a parametrical configuration extending about an open inner region and defining a lateral passage communicating with the open inner region.
- an apparatus for supporting vertebral bodies, including a first horseshoe-shaped member adapted to engage a first vertebral body, a second horseshoe-shaped member adapted to engage a second vertebral body, and at least one elongate support member coupled between the first and second horseshoe-shaped members to maintain an axial space between the first and second vertebral bodies.
- an apparatus for supporting vertebral bodies, including a first end member adapted to engage a first vertebral body, a second end member adapted to engage a second vertebral body, at least one elongate support member coupled between the first and second end members to maintain an axial space between the first and second vertebral bodies, and a fusion member positioned within the axial space to promote bony fusion between the first and second vertebral bodies.
- a method for supporting vertebral bodies of a spinal column including providing first and second end members each having a parametrical configuration extending about an open imier region and defining a lateral passage communicating with the open inner region, and providing at least one elongate support member.
- the method further includes positioning the first end member adjacent a first vertebral body, positioning the second end member adjacent a second vertebral body, and coupling the elongate support member between the first and second end members to maintain an axial space between the first and second vertebral bodies.
- a method for supporting vertebral bodies of a spinal column including providing first and second end members each including an axial passage extending therethrough, providing at least one elongate support member, and providing fusion material.
- the method further includes positioning the first end member in the axial space and adjacent an endplate ofthe first vertebral body with the axial passage ofthe first end member arranged along the sagittal plane ofthe spinal column, positioning the second end member in the axial space and adjacent an endplate ofthe second vertebral body with the axial passage ofthe second end member ananged along the sagittal plane ofthe spinal column, coupling the elongate support member between the first and second end members to maintain the axial space between the first and second vertebral bodies, and positioning the fusion material within the axial space adjacent the axial passages ofthe first and second end members to promote bony fusion between the endplates ofthe first and second vertebral bodies.
- the apparatus 20 is a modular vertebrectomy cage assembly positionable within an intervertebral space to span one or more vertebral levels along the longitudinal axis ofthe spinal column.
- the illustrated embodiment ofthe cage assembly 20 spans three vertebral levels (FIG. 4), it should be understood that the cage assembly 20 may be configured to span a single vertebral level, two vertebral levels, or four or more vertebral levels.
- the cage assembly 20 is generally comprised of a first end member 22, a second end member 24, and one or more elongate support members or rods 26 coupled between the first and second end members 22, 24.
- the cage assembly 20 has been illustrated as including a pair of support rods 26, it should be understood that any number of support rods may be used, including a single support rod or three or more support rods.
- the support rods 26 have a solid configuration and a generally cylindrical shape.
- the support rods 26 may be configured as hollow tubes.
- the support rods 26 may take on other cross-sectional shapes, such as, for example, rectangular, hexagonal or elliptical cross-sectional shapes, or any other cross-sectional shape that would occur to one of skill in the art.
- the end members 22, 24 are adapted to engage the endplates of upper and lower vertebral bodies Vu, V L (FIG. 4).
- the support rods 26 are engaged between the end members 22, 24 to maintain an intervertebral axial space S between the upper and lower vertebral bodies Vu, V L following the removal of one or more vertebral levels (shown in phantom).
- the support rods 26 are engaged to the end members 22, 24 via a number of fasteners, such as, for example, set screws 28.
- fasteners such as, for example, set screws 28.
- other means for engaging the support rods 26 to the end members 22, 24 are also contemplated as falling within the scope ofthe present invention.
- the end members 22, 24 are formed of a radiolucent material, such as, for example, a carbon fiber material. In this manner, x-ray viewing ofthe intervertebral space S and the vertebral endplates subsequent to implantation ofthe cage assembly 20 will be relatively unobstructed.
- the end members 22, 24 may be formed of other suitable materials, such as, for example, stainless steel, titanium or other biocompatible materials.
- the support rods 26 are formed of stainless steel, titanium or other biocompatible materials.
- the support rods 26 and/or any other component ofthe cage assembly 20 may be formed of a radiolucent material, such as, for example, a carbon fiber material.
- end members 22, 24 are configured identical to one another. However, it should be understood that in other embodiments ofthe invention, the end members 22, 24 can take on different configurations, examples of which will be illustrated and described below.
- each ofthe end members 22, 24 has a parametrical configuration extending about an open inner region 30 and defining a lateral passage 32 communicating with open inner region 30.
- the end members 22, 24 are generally horseshoe-shaped.
- the end members 22, 24 could also be described as being U-shaped, C-shaped, V-shaped, semi-circular shaped, semi-oval shaped, or other tenns that could be used to describe a shaped element defining an open inner region and a lateral passage communicating therewith.
- the end members 22, 24 may take on other types of hollow configurations, such as, for example, a circular shape, semi-oval shape, kidney shape, D-shape, or any other shape that would occur to one of skill in the art.
- the end members 22, 24 may take on substantially solid configurations, such as, for example, blocklike or plate-like configurations that do not define an open inner region. It should further be appreciated that the size and/or configuration ofthe end members
- the end members 22, 24 may be specifically designed to accommodate any particular region ofthe spinal column and/or any particular vertebral level.
- the end members 22, 24 may be designed to have a D-shaped configuration
- embodiments ofthe invention associated with the lumbar region ofthe spine may be configured to have a horseshoe-shape, a U-shape, or other types of open-sided configurations.
- the end members 22, 24 have a lateral profile that is substantially complementary to the size and shape ofthe peripheral portion or outlying region ofthe vertebral bodies, such as the cortical rim or the apophyseal ring ofthe vertebral endplates. For example, as illustrated in FIG.
- the outer perimeter ofthe end member 24 is preferably disposed generally above the inner edge ofthe cortical rim R ofthe lower vertebral body VL- In this manner, at least a portion ofthe end members 22, 24 is engaged against the cortical region ofthe vertebral endplates, thereby minimizing the likelihood of subsidence into the relatively softer cancellous region ofthe upper and lower vertebral bodies Vu, VL following implantation ofthe cage assembly 20 within the intervertebral space S.
- the parametrical configuration ofthe end members 22, 24 in combination with the relatively large surface area ofthe end members 22, 24 engaged against the vertebral endplates enhances the overall stability ofthe cage assembly 20.
- the open imier region 30 defined by each ofthe end member 22, 24 provides significant exposure ofthe vertebral endplates to enhance bony fusion between the upper and lower vertebral bodies Vu, V L , the details of which will be discussed below.
- the end members 22, 24 include a main body or base portion 40 and a pair of oppositely disposed wings or side portions 42a, 42b extending from the base portion 40.
- the base portion 40 and the side portions 42a, 42b cooperate to define the open inner region 30, with the distal ends ofthe side portions 42a, 42b defining the lateral passage 32 therebetween.
- the lateral surface ofthe base portion 40 facing the open imier region 30 defines a recessed area 43 to eliminate the presence of sharp comers and which also serves to provide for a slightly larger open inner region 30 which corcespondingly increases exposure ofthe vertebral endplates to enhance fusion capabilities.
- the upper/lower engaging surface 44 ofthe end members 22, 24 is substantially planar and defines surface features and/or a number of anchor elements adapted for engagement with the vertebral endplates to inhibit movement ofthe end members 22, 24 relative to the upper and lower vertebral bodies Vu, VL-
- the upper/lower engaging surfaces 44 may be roughened, such as, for example, by knurling and/or etching (e.g., photochemical etching).
- various types of projections or protrusions may extend from the upper/lower engaging surfaces 44, such as, for example, a number of spikes, ridges, teeth, axial grooves, checkerboard-type grooves, or any other type of anchoring element that would occur to one of skill in the art.
- the upper/lower engaging surfaces 44 of the end members 22, 24 are illustrated as being ananged substantially parallel to one another when the cage assembly 20 is fully assembled (FIG. 1), it should be understood that the upper/lower engaging surfaces 44 may be tapered relative to one another to more closely conform with the anatomical curvature of the spine at the surgical site (e.g., the angle of lordosis or kyphosis).
- the support rods 26 may be bent and/or provided with a predetermined curvature to more closely match the configuration ofthe cage assembly 20 with the anatomical curvature ofthe spine at the surgical site.
- the base portion 40 ofthe end members 22, 24 defines a pair of sockets or receptacles 46a, 46b sized to receive end portions of respective support rods 26 therein. It should be understood, however, that the base portion 40 may define any number of sockets or receptacles for receiving a corresponding number of support rods, including a single socket or three or more sockets.
- the sockets 46a, 46b each define a lateral opening 48 sized to receive the end portion of a conesponding support rod 26 therethrough.
- the end portions ofthe support rods 26 may be laterally inserted into the sockets 46a, 46b via a side-loading technique, preferably from a posterior direction. Lateral insertion ofthe support rods 26 may be particularly advantageous when assembling the cage assembly 20 in situ within the intervertebral space iS.
- the lateral openings 48 are preferably general aligned with the lateral passage 32 defined between the side portions 42a, 42b to further enhance the ability to laterally insert the support rods 26 into the sockets 46a, 46b.
- the sockets 46a, 46b each define a thru-opening 50 extending axially through the end members 22, 24 and sized to slidably receive the end portion of a conesponding support rod 26 therethrough.
- This embodiment ofthe invention may also be particularly advantageous when assembling the cage assembly 20 in situ within the intervertebral space S.
- sockets 46a, 46b may take on other alternative configurations.
- the end members 122, 124 associated with the cage assembly 100 define sockets that do not define lateral openings, but instead define a closed configuration.
- engagement ofthe support rods 126 with the end members 122, 124 would occur via axial insertion ofthe end portions ofthe support rods 126 into the sockets ofthe end members 122, 124.
- the end members 222, 224 associated with the cage assembly 200 also define a closed configuration.
- the sockets 46a, 46b have been illustrated as defining an axial thru-opening 50, in other embodiments of the invention, the sockets 46a, 46b may alternative define a closed or blind bottom configuration.
- the sockets 46a, 46b each define a laterally-extending threaded aperture 52 that is adapted to threadingly receive a conesponding set screw 28 therein (FIG. 1).
- the threaded apertures 52 are preferably generally aligned with the lateral passage 32 defined between the side portions 42a, 42b to provide substantially uninhibited access to the set screws 28 to facilitate tightening ofthe set screws 28 into the end members 22, 24.
- this setup may be particularly advantageous when assembling the cage assembly 20 in situ within the intervertebral space S.
- the threaded aperture 52 extend along axes 54a, 54b that are outwardly tapered relative to one another and to the sagittal plane P extending along the spinal column when the cage assembly 20 is positioned within the intervertebral space S (FIG. 5). Arrangement ofthe set screw axes 54a, 54b in a diverging relationship tends to enhance the accessibility ofthe set screws 28.
- the set screw axes 54a, 54b are arranged to define an included angle ⁇ of about ten (10) to twenty (20) degrees. In a specific embodiment, the included angle ⁇ is about sixteen (16) degrees.
- the set screws 28 are ofthe break-off type, including a head portion that is selectively removable from a threaded shank portion, the details of which will be discussed below.
- set screws have been illustrated and described as the preferred means for coupling the support rods 26 to the end members 22, 24, other elements or devices may alternatively he used, such as, for example, various types of fasteners, snap rings, collets, collars, wedges, or any other type of element or device capable of coupling the support rods 26 to the end members 22, 24.
- each support rod 26 may be threadingly engaged with a conesponding threaded portion defined by each ofthe end members 22, 24.
- the end members 22, 24 each define a tool receiving aperture 56.
- the tool receiving apertures 56 are sized and shaped to receive a conesponding end portion of a tool or instrument therein to facilitate insertion ofthe cage assembly 20 into the intervertebral space S, manipulation ofthe end members 22, 24 relative to the support rods 26, and/or distraction ofthe intervertebral space S.
- the tool receiving apertures 56 are illustrated as having a generally circular configuration, other shapes and configurations are also contemplated, such as, for example, hexagonal or rectangular configurations.
- the tool receiving apertures 56 are formed in the base portion 40 ofthe end members 22, 24 through an inwardly facing surface 58 (the surface opposite the outer engaging surface 44).
- the tool receiving apertures 56 may be formed in other portions of the end members 22, 24, including the side portions 42a, 42b (see FIGS. 9 and 10), and through other surfaces, such as the laterally extending surfaces ofthe end members 22, 24.
- the sockets 46a, 46b associated with the end members 22, 24 have been depicted as having an axially extending cylindrical configuration adapted to receive a correspondingly shaped end portion of a support rod 26 therein. In this manner, when the support rods 26 are properly positioned within the sockets
- the support rods 26 will be ananged at a predetermined angular orientation relative to the end members 22, 24, which in rum arranges the end members 22, 24 at predetermined angular orientations relative to one another.
- the sockets 46a, 46b and/or the end portions ofthe support rods 26 may be configured such that the angular orientation of the support rods 26 relative to the end members 22, 24 may be varied or adjusted to conespondingly anange the end members 22, 24 at select angular orientations relative to one another.
- the cage assembly 400 is generally comprised of a first end member 422, a second end member 424, and one or more elongate support members or rods 426 coupled between the first and second end members 422, 424.
- the cage assembly 400 is configured to allow the support rods 426 to pivot relative to at least one ofthe end members 422, 424, and includes a number of fasteners, such as, for example, set screws 428 (FIG. 16) adapted to lock the support rods 426 at a select angular orientation relative to the end members 422, 424.
- the cage assembly 400 has been illustrated as including a pair of support rods 426, it should be understood that any number of support rods may be used, including a single support rod or three or more support rods.
- the support rods 426 are configured similar to the support rods 26 illushated and described above with regard to the cage assembly 20, having a solid configuration and a substantially cylindrical shape. However, unlike the support rods 26, one end portion ofthe support rods 426 defines a spherical-shaped end portion 427, the purpose of which will be discussed below, with the opposite end portion defining an axially extending cylindrical configuration. In this manner, the end portion defining the axially extending cylindrical configuration may be cut to an appropriate length that provides the cage assembly 400 with an overall height which closely matches the natural or conected height ofthe intervertebral space S. It should be understood, however, that in other embodiments ofthe invention, each end portion ofthe support rods 426 may define a spherical-shaped end portion 427.
- the end member 422 is configured substantially identical to the end members 22, 24 illustrated and described above with regard to the cage assembly 20, including sockets configured similar to sockets 46a, 46b for receiving the axially extending cylindrical end portions ofthe support rods 426 therein.
- the end member 424 is configured similar to the end member 422.
- the end member 424 has a parametrical configuration extending about an open inner region 430 and defining a lateral passage 432 communicating with the open inner region 430.
- the end member 424 has a base portion 440, a pair of oppositely disposed wings or side portions 442a, 442b, an upper/lower engaging surface 444, a pair of sockets or receptacles 446a, 446b defining lateral openings 448, threaded aperture 452 extending along axes 454a, 454b, and a tool receiving aperture 456.
- the end member 424 is configured to pivotally receive the spherical-shaped end portions 427 ofthe support rods 426 to allow for relative pivotal movement between the support rods 426 and the end member 424, the details of which will follow.
- the sockets 446a, 446b each include an axially extending cylindrical-shaped portion 460 and a spherical-shaped recessed portion 462 sized and shaped to receive the spherical-shaped end portion 427 of a respective support rod 426 therein. In this manner, the support rods 426 are allowed to pivot relative to the end member
- ananging the end members 424 at a select angular orientation relative to the end member 422 may be particularly useful to more closely match the configuration ofthe cage assembly 400 with the anatomical features associated with the intervertebral space S (e.g., the angle of lordosis or kyphosis).
- each ofthe support rods 426 need not necessarily have the same overall length. Instead, the support rods 426 may define different lengths to allow for more precise adjustment ofthe angular orientation between the end members 422, 424, particularly in cases where the support rods 426 are not ananged along a common plane, such as, for example, the support rods 126 associated with the cage assembly 100 (FIGS. 7 and 8). Additionally, the support rods 426 may be curved or bent to provide further adjustment to the angular orientation between the end members 422, 424.
- the support rod 426 is allowed to pivot up to an angle ⁇ i in any direction, limited only by engagement ofthe support rod 426 against a surface 466 defined by the cylindrical portion 460 ofthe sockets 446a, 446b.
- the surface 466 is tapered at an angle approximately equal to the angle ⁇ i.
- at least a portion ofthe spherical-shaped recessed portion 462 ofthe sockets 446a, 446b defines a number of surface projections or protrusions 464, such as, for example, a series of ridges or teeth and/or spikes, the purpose of which will be discussed below.
- the surface projections or protrusions 464 are positioned generally opposite the threaded aperture 452; however, it should be understood that other positions configurations are also contemplated.
- the threaded aperture 452 communicating with the sockets 446a, 446b has a diameter approximately equal to or slightly greater than the diameter ofthe spherical-shaped recessed portion 462.
- the spherical-shaped end portions 427 ofthe support rod 426 may be laterally inserted into the sockets 446a, 446b via a side-loading technique, which may be particularly advantageous when assembling the cage assembly 400 in situ within the intervertebral space S.
- the cylindrical portion 460 ofthe sockets 446a, 446b has a diameter somewhat less than the spherical-shaped end portion 427 ofthe support rod 426 to aid in retaining the support rods 426 in axial engagement with the end member 424.
- a set screw 428 is threadingly advanced through the threaded aperture 452 and into engagement with the spherical-shaped end portion 427 to lock the support rod 426 in a select angular orientation relative to the end member 424.
- the set screws 428 is ofthe break-off type, including a threaded shank portion 470 adapted for engagement within the threaded aperture
- the head portion 472 extending from the threaded shank portion 470 and adapted for engagement by the distal end portion of a driving tool (not shown).
- the head portion 472 is selectively removable from the threaded portion 470.
- the head portion 472 is attached to the threaded portion 470 via a frangible region or fracture initiator 474 adapted to allow the head portion 472 to be snapped off or broken away from the threaded portion 470 once properly engaged against the spherical end portion 427 ofthe support rod 426.
- the distal end ofthe threaded portion 470 defines a number of projections or protrusions 476, such as, for example, a ring-like ridge and/or a series of teeth or spikes that are configured to enhance engagement ofthe set screw 428 with the spherical end portion 427 ofthe support rod 426 to provide additionally resistance to relative pivotal movement between the end member 424 and the support rod 426.
- a number of projections or protrusions 476 such as, for example, a ring-like ridge and/or a series of teeth or spikes that are configured to enhance engagement ofthe set screw 428 with the spherical end portion 427 ofthe support rod 426 to provide additionally resistance to relative pivotal movement between the end member 424 and the support rod 426.
- the cage assembly 500 is generally comprised of a first end member 522, a second end member 524, and one or more elongate support members or rods 526 coupled between the first and second end members 522, 524.
- the cage assembly 500 is configured to allow the support rods 526 to pivot relative to at least one ofthe end members 522, 524, and includes a number of fasteners, such as, for example, set screws 528 (FIG. 19) adapted to lock the support rods 526 at a select angular orientation relative to the end members 522, 524.
- the cage assembly 500 has been illustrated as including a pair of support rods 526, it should be understood that any number of support rods may be used, including a single support rod or three or more support rods.
- the support rods 526 are configured similar to the support rods 426 illustrated and described above with regard to the cage assembly 400. However, instead of defining a spherical-shaped end portion, the support rods 526 define a cylindrical-shaped end portion
- each end portion ofthe support rods 526 may define a transversely extending cylindrical-shaped end portion 527.
- the end member 522 is configured substantially identical to the end member 422 illustrated and described above with regard to the cage assembly 400, including sockets configured to receive the axially extending cylindrical end portions ofthe support rods 526 therein.
- the end member 524 is configured similar to the end member 522.
- the end member 524 has a parametrical configuration extending about an open inner region 530 and defining a lateral passage 532 communicating with the open inner region 530.
- the end member 524 has a base portion 540, a pair of oppositely disposed wings or side portions 542a, 542b, an upper/lower engaging surface 544, a pair of sockets or receptacles 546a, 546b defining lateral openings 548, threaded aperture 552 extending along axes 554a, 554b, and a tool receiving aperture 556.
- the end member 524 is configured to pivotally receive the cylindrical-shaped end portions 527 ofthe support rods 526 to allow for relative pivotal movement between the support rods 526 and the end member 524, the details of which will follow.
- the sockets 546a, 546b each include an axially extending cylindrical-shaped portion 560 and a transversely extending cylindrical-shaped recessed portion 562 sized and shaped to receive the cylindrical-shaped end portion 527 of a respective support rod 526 therein.
- the support rods 526 are allowed to pivot relative to the end member 524 in a hinge-like manner about a transverse axis T within a range of angular orientations.
- the end portion 527 ofthe support rods 526 and the corresponding socket 546a, 546b ofthe end member 524 are configured to allow selective angular displacement ofthe support rods 526 relative to the end member 524 about a single axis.
- This mono-axial configuration substantially prevents angular displacement ofthe support rods 526 relative to the end member 524 about any axis other than the transverse axis T.
- alternative configurations are also contemplated, including bi-axial configurations wherein the end portions 527 ofthe support rods 526 and the corresponding sockets 546a, 546b are configured to allow selective angular displacement ofthe support rods 526 relative to the end member 524 about two axes (e.g., the transverse axis T and an axis ananged substantially perpendicular to and co-planar with the transverse axis T).
- the cage assembly 400 other multi-axial configurations are also contemplated as falling within the scope ofthe present invention.
- the support rod 526 is allowed to pivot up to an angle ⁇ 2 along a single plane (e.g., in a posterior-anterior direction), limited only by engagement ofthe support rod 526 against a surface 566 defined by the axially-extending cylindrical portion 560 ofthe sockets 546a, 546b.
- the surface 566 is tapered at an angle approximately equal to the angle ⁇ 2 .
- at least a portion ofthe cylindrical-shaped recessed portion 562 ofthe sockets 546a, 546b defines a number of surface projections or protrusions 564, such as, for example, a series of ridges or teeth and/or spikes, the purpose of which will be discussed below.
- the surface projections or protrusions 564 are positioned generally opposite the threaded aperture 552; however, it should be understood that other configurations are also contemplated.
- the threaded aperture 552 is configured to receive the cylindrical-shaped end portion 527 ofthe support rod 526 therethrough such that the end portion 527 may be laterally inserted into the sockets 546a, 546b via a side- loading technique.
- the cylindrical portion 560 of the sockets 546a, 546b has a diameter somewhat less than the outer cross-section ofthe end portion 527 to aid in retaining the support rods 526 in axial engagement with the end member 524.
- a set screw 528 is threadingly advanced through the threaded aperture 552 and into engagement with the end portion 527 to lock the support rod 526 in a select angular orientation relative to the end member 524.
- the set screw 528 may be configured similar to the break-off type set screw
- the distal end ofthe set screw 528 preferably defines a number of projections or protrusions 576, such as, for example, a ring-like ridge and/or a series of teeth or spikes that are configured to enhance engagement ofthe set screw 528 with the cylindrical-shaped end portion 527 of the support rod 526 to provide additionally resistance to relative pivotal movement between the end member 524 and the support rod 526.
- a number of projections or protrusions 576 such as, for example, a ring-like ridge and/or a series of teeth or spikes that are configured to enhance engagement ofthe set screw 528 with the cylindrical-shaped end portion 527 of the support rod 526 to provide additionally resistance to relative pivotal movement between the end member 524 and the support rod 526.
- FIGS. 4 and 5 shown therein is the cage assembly 20 positioned between the upper and lower vertebral bodies Vu, V L to maintain the intervertebral space S following removal of a number of vertebral levels (shown in phantom).
- the end members 22, 24 and the support members 26 are configured to allow the cage assembly 20 to be assembled in situ within the intervertebral space S.
- the components ofthe cage assembly 20 may be endoscopically inserted into and assembled within the intervertebral space S in a minimally invasive manner, hi another embodiment ofthe invention, the components ofthe cage assembly 20 may be assembled into one or more sub-assemblies outside ofthe intervertebral space S, with final assembly ofthe cage assembly 20 taking place in situ within the intervertebral space S. In a further embodiment ofthe invention, the cage assembly 20 may be entirely pre-assembled outside ofthe patient's body prior to insertion within the intervertebral space S.
- the entire cage assembly 20 or the individual components ofthe cage assembly 20 are inserted into the intervertebral space S via a posterior surgical approach.
- the cage assembly 20 or the individual components ofthe cage assembly 20 may be inserted into the intervertebral space S via other surgical approaches, such as, for example, an anterior approach or a lateral approach.
- the open inner regions 30 ofthe end members 22, 24 are preferably positioned generally along the sagittal plane P, with the lateral passages 32 and the open inner region 30 generally facing a posterior direction.
- the engaging surfaces 44 ofthe end members 22, 24 are positioned against the endplates ofthe upper and lower vertebral bodies Vu, VL, with the support members 26 extending between the end members 22, 24 to maintain a desired height ofthe intervertebral space S.
- the outer peripheral portion ofthe end member 24 (as well as the end member 22) is preferably positioned generally above the inner edge ofthe cortical rim R ofthe vertebral body. In this manner, at least a portion ofthe end members 22, 24 is engaged against the relatively hard cortical portion ofthe vertebral endplates, thereby minimizing the likelihood of subsidence ofthe cage assembly 20 into the relatively soft cancellous portion ofthe upper and lower vertebral bodies Vu, VL.
- the open inner region 30 defined by each ofthe end member 22, 24 provides significant exposure ofthe vertebral endplates to enliance bony fusion between the upper and lower vertebral bodies Vu, V L .
- the support rods 26 may be inserted through the lateral passages
- the support rods 26 may be pre-assembled with the end members 22, 24 prior to insertion into the intervertebral space S. Once the support rods 26 are engaged within the sockets 46a, 46b, the set screws 28 are tightened into engagement against the end portions ofthe support rods 26. The set screws 28 function to secure the support rods 26 to the end members 22, 24, thereby fixing the overall height h ofthe cage assembly 20 to maintain the desired height ofthe intervertebral space S.
- the cage assembly 20 may include a number of elongate rods or posts 29 (shown in phantom).
- the elongate posts 29 are coupled to the end members 22, 24 and extend outside ofthe intervertebral space S.
- the elongate posts 29 extend from the set screws 28, and in a further embodiment are formed integral with the set screws 28 to define a unitary, single-piece structure.
- the elongate posts 29 provide a means for coupling various components to the cage assembly 20 at a location outside ofthe intervertebral space S.
- various types and configurations of spinal stabilization systems such as, for example, plate or rod type systems, may be operably attached to the elongate posts 29 to provide additional stability and structural integrity to the cage assembly 20 and/or to provide additional stabilization and support to tire portion ofthe spinal column being treated.
- the entire cage assembly 20 or the individual components ofthe cage assembly 20 may be inserted into the intervertebral space S via a posterior surgical approach.
- a posterior insertion technique illustrated therein is a posterior insertion technique according to one embodiment ofthe present invention.
- the parametrical configuration ofthe end members 22, 24 facilitates advancement ofthe end members 22, 24 and/or the entire cage assembly 20 around the spinal cord C and into the intervertebral space S in such a manner as to minimize retraction and/or manipulation ofthe spinal cord C and other neural structures.
- the spinal cord may be slightly retracted in a lateral direction in the direction of arrow 80 via a retractor instrument 82.
- the spinal cord C need not necessarily be retracted to accommodate insertion ofthe cage assembly 20 into the intervertebral space S.
- various types and configurations of fusion devices and/or bone growth promoting materials may be introduced within the intervertebral space adjacent the cage assembly to facilitate or promote bony fusion between the upper and lower vertebral bodies Vu, VL-
- fibular strut 190 disposed between the upper and lower vertebral bodies Vu, V L adjacent the cage assembly 100.
- the fibular strut 190 has opposite end portions that are positioned within the open imier regions 130 of each ofthe end members 122, 124, and are preferably positioned in intimate engagement with the vertebral endplates of the upper and lower vertebral bodies Vu, V L -
- a fusion cage 192 disposed between the upper and lower vertebral bodies Vu, V L adjacent the cage assembly 100.
- the fusion cage 192 has a cylindrical-shaped configuration and is fonned of mesh material.
- other types, shapes and configurations of fusion cages are also contemplated for use in association with the present invention.
- the mesh fusion cage 192 has opposite end portions that are positioned within the open inner regions 130 of each ofthe end members 122, 124, and are preferably positioned in intimate engagement with the vertebral endplates.
- the mesh fusion cage 192 may be filled with various types of bone growth materials to promote bony fusion between the upper and lower vertebral bodies Vu, VL, the details of which would be apparent to one of skill in the art. It should be understood that other types of cages or devices for containing bone growth materials are also contemplated as falling within the scope ofthe present invention.
- a bone growth material 290 disposed between the upper and lower vertebral bodies Vu, V adjacent the cage assembly 200.
- the material 290 is contained within the intervertebral space S via a resorbable film or membrane
- the resorbable film 292 is comprised of an inner film portion 292a extending about the imier perimeter ofthe cage assembly 200, and an outer film portion 292b positioned across the open posterior side ofthe cage assembly 200 to fully contain the bone growth material 290 therein. It should be understood that the inner portion 292a ofthe resorbable film 292 may extend entirely about the bone growth material 290 to fully encase the material 290. It should also be understood that the resorbable film 292 may extend about the outer perimeter ofthe cage assembly 200 to contain the bone growth material 290 within the intervertebral space S. Other types of devices and materials for containing the bone growth material 290 are also contemplated for use in association with the present invention, including the use of non-resorbable materials.
- bone growth materials may include, for example, bone graft, bone morphogenetic protein (BMP), allograft, various types of cement, transforming growth factor Bl, insulin-like growth factor 1, platelet-derived growth factor, fibroblast growth factor, and LIM mineralization protein.
- BMP bone morphogenetic protein
- allograft various types of cement
- transforming growth factor Bl insulin-like growth factor 1
- platelet-derived growth factor fibroblast growth factor
- LIM mineralization protein LIM mineralization protein
- the bone growth promoting materials may be provided in a carrier, such as, for example, a sponge, a block, folded sheets, putty and/or paste.
- the cage assembly 100 includes a first end member 122, a second end member 124, and three elongate support rods 126 coupled between the first and second end members 122, 124 and engaged thereto via a number of fasteners or set screws 128.
- the support rods 126 are preferably spaced about the end members 122, 124 and the open inner region 130 in a generally uniform manner.
- the cage assembly 200 includes a first end member 222, a second end member 224, and two elongate support rods 226 coupled between the first and second end members 222, 224 and engaged thereto via a number of fasteners or set screws 228.
- the anterior portions ofthe end members 222, 224 are somewhat less prominent than the anterior portions ofthe end members 22, 24, thereby providing for a slightly larger open inner region 230 which in turn provides for a slightly greater exposure ofthe vertebral endplates.
- the distractor 300 extends along a longitudinal axis L and is generally comprised of a first distractor arm 302 and a second distractor arm 304.
- the first and second distractor anns 302, 304 are coupled to one another via a hinge mechanism or pivot pin 306 which provides for pivotal movement between the distractor arms 302, 304 about a pivot axis 308.
- a hinge mechanism or pivot pin 306 which provides for pivotal movement between the distractor arms 302, 304 about a pivot axis 308.
- an inward compression force exerted onto the proximal portions 302a, 304a of the distractor arms in the direction of anows A will cause the distal end portions 302b, 304b to be outwardly displaced in the direction of anows B.
- the distractor 300 is provided with a gauge or stop member 310 that is adapted to limit outward displacement ofthe distal end portion 302b, 304b, which in turn conespondingly limits that amount of distraction provided by the distractor arms 302, 304.
- the gauge member 310 is configured as a threaded rod having a first end portion 310a engagable with the proximal end portion 304a ofthe distractor arm 304, and a second end portion 310b engaged within an opening or slot 312 extending through the proximal end portion 302a ofthe distractor arm 302.
- the position of rod 310 may be adjusted relative to the distractor arm 302 (e.g., by threading the rod 310 into or out ofthe opening 312) to conesponding control the maximum amount of distraction provided by the distractor arms 302, 304. In this manner, over distraction ofthe intervertebral space S is avoided.
- the distal end portions 302b, 304b ofthe distractor arms 302, 304 preferably define a lateral offset relative to the longitudinal axis L, the purpose of which will be discussed below.
- the distal end portions 302b, 304b have an arcuate-shaped configuration defining the lateral offset.
- other shapes and configurations ofthe distal end portions 302b, 304b are also contemplated.
- the distal end portions 302b, 304b each preferably define an outwardly extending projection
- the projections 320 have a hemi-spherical configuration; however, other shapes and configurations are also contemplated.
- the distractor arms 302, 304 are engagable with the end members 22, 24, respectively, via insertion ofthe projections 320 within the tool receiving apertures 56.
- the components ofthe cage assembly 20 are preferably inserted into the intervertebral space S via a posterior surgical approach.
- the distractor 300 is likewise preferably inserted into the intervertebral space S via a posterior surgical approach.
- the longitudinal axis L ofthe distractor 300 is generally aligned with the patient's spinal cord C when the distractor arms 302, 304 are properly engaged with the end members 22, 24.
- the lateral offset defined by the distal end portions 302b, 304b ofthe distractor arms 302, 304 provide the distractor 300 with the ability to wrap or extend around the spinal cord C to minimize manipulation and retraction ofthe spinal cord C while still maintaining secure and stable engagement with the end members 22, 24. In this manner, the risk of injury or trauma to the spinal cord C and other neural structures is reduced.
- the distal end portions 302b, 304b are outwardly displaced or spread apart, which in turn urges the end members 22, 24 against the opposing vertebral endplates to distract the upper and lower vertebral bodies Vu, VL to a desired distraction height.
- the set screws 28 are tightened into engagement with the support rods 26 to fix the overall height h ofthe cage assembly 20 and to maintain the desired distraction height ofthe intervertebral space S.
- a fusion device and/or a bone growth material may then be inserted into the intervertebral space S adjacent the cage assembly 20.
- various types of fusion devices or materials may be used to facilitate or promote bony fusion between the upper and lower vertebral bodies Vu, VL inlcuding, for example, the fibular strut 190, the fusion cage 192, or the bone growth material 290 contained within the intervertebral space S via the resorbable film 292.
- the support rods 26 are preloaded into the sockets 46a, 46b ofthe end members 22, 24 prior to distraction ofthe intervertebral space S, with the end portions ofthe support rods 26 extending through the axial thru-openings 50 associated with at least one ofthe end members 22, 24. In this manner, during distraction, at least one ofthe end members 22, 24 is slidably displaced along the support rods 26 until the desired distraction height is attained, followed by tightening ofthe set screws 28 to fix the overall height h ofthe cage assembly 20.
- the end members 22, 24 may be inserted into the intervertebral space S and spread apart until the desired distraction height is attained, followed by insertion ofthe support rods 26 into the sockets 46a, 46b and tightening ofthe set screws 28 to fix the overall height h ofthe cage assembly 20.
- the cage assemblies 20, 100, 200, 400 and 500 ofthe present invention enable complete vertebral reconstruction following a vertebrectomy, preferably via a posterior surgical approach.
- the components ofthe cage assemblies extend or wrap about the spinal cord C and emerging nerve roots to minimize the risk of injury to these neural structures.
- the upper and lower end members ofthe cage assemblies are engaged against the cortical rim or apophyseal ring ofthe vertebral endplates, thereby reducing the likelihood of subsidence into the upper and lower vertebrae.
- the cage assemblies ofthe present invention also provide substantial exposure ofthe vertebral endplates to promote fusion between the upper and lower vertebral bodies.
- the cage assemblies provide for relatively uninhibited post-operative follow up with regard to verification of proper fusion/bone growth between the upper and lower vertebral bodies.
Abstract
Description
Claims
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CA002523609A CA2523609A1 (en) | 2003-04-03 | 2004-03-31 | Apparatus and method for supporting vertebral bodies |
EP04749539A EP1615599B1 (en) | 2003-04-03 | 2004-03-31 | Apparatus for supporting vertebral bodies |
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US7320708B1 (en) * | 2002-11-13 | 2008-01-22 | Sdgi Holdings, Inc. | Cervical interbody device |
-
2003
- 2003-04-03 US US10/407,010 patent/US7563281B2/en not_active Expired - Lifetime
-
2004
- 2004-03-31 CA CA002523609A patent/CA2523609A1/en not_active Abandoned
- 2004-03-31 EP EP04749539A patent/EP1615599B1/en not_active Expired - Lifetime
- 2004-03-31 WO PCT/US2004/009748 patent/WO2004089260A1/en active Application Filing
- 2004-03-31 AU AU2004227832A patent/AU2004227832B9/en not_active Ceased
- 2004-03-31 DE DE602004018295T patent/DE602004018295D1/en not_active Expired - Lifetime
- 2004-03-31 AT AT04749539T patent/ATE416731T1/en not_active IP Right Cessation
-
2009
- 2009-01-16 US US12/321,186 patent/US8012213B2/en not_active Expired - Fee Related
-
2011
- 2011-05-04 US US13/100,614 patent/US8613769B2/en not_active Expired - Lifetime
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Publication number | Priority date | Publication date | Assignee | Title |
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FR2636227A1 (en) * | 1988-09-09 | 1990-03-16 | Fabrication Materiel Orthopedi | Inter-spinal-body device for holding a normal spacing between two vertebrae |
US5062850A (en) * | 1990-01-16 | 1991-11-05 | University Of Florida | Axially-fixed vertebral body prosthesis and method of fixation |
DE9413778U1 (en) * | 1994-08-26 | 1996-01-04 | Schaefer Micomed Gmbh | Intervertebral implant |
US5645084A (en) * | 1995-06-07 | 1997-07-08 | Danek Medical, Inc. | Method for spinal fusion without decortication |
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Also Published As
Publication number | Publication date |
---|---|
CA2523609A1 (en) | 2004-10-21 |
US20040199252A1 (en) | 2004-10-07 |
AU2004227832B2 (en) | 2010-07-08 |
DE602004018295D1 (en) | 2009-01-22 |
AU2004227832B9 (en) | 2010-11-18 |
AU2004227832A1 (en) | 2004-10-21 |
US8613769B2 (en) | 2013-12-24 |
EP1615599A1 (en) | 2006-01-18 |
EP1615599B1 (en) | 2008-12-10 |
US7563281B2 (en) | 2009-07-21 |
ATE416731T1 (en) | 2008-12-15 |
US8012213B2 (en) | 2011-09-06 |
WO2004089260A8 (en) | 2004-11-25 |
US20090132053A1 (en) | 2009-05-21 |
US20110208314A1 (en) | 2011-08-25 |
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