US20100191333A1 - Load-bearing spinal interbody device - Google Patents
Load-bearing spinal interbody device Download PDFInfo
- Publication number
- US20100191333A1 US20100191333A1 US12/726,112 US72611210A US2010191333A1 US 20100191333 A1 US20100191333 A1 US 20100191333A1 US 72611210 A US72611210 A US 72611210A US 2010191333 A1 US2010191333 A1 US 2010191333A1
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- US
- United States
- Prior art keywords
- interbody device
- inner dampener
- dampener
- interbody
- thickness
- Prior art date
- Legal status (The legal status 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 status listed.)
- Abandoned
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- 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
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/442—Intervertebral or spinal discs, e.g. resilient
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Definitions
- the present invention relates to fusion and non-fusion spinal interbody devices.
- the present invention answers this need by providing an interbody device with both rigid and compressible components for both supporting and absorbing axial loads while limiting subsidence and endplate erosion.
- the compressible components include material of greater compressibility than material of rigid components.
- rigid material may include, but is not limited to, biocompatible materials such as polyetheretherketone (PEEK), carbon fiber reinforced PEEK such as PEEK-Optima (Invibio, Inc., West Conshohocken, Pa.) and other biocompatible polymeric materials.
- PEEK polyetheretherketone
- rigid material may include biocompatible metals, including without limitation titanium, stainless steel and cobalt chromium alone or in combination with other materials.
- the compressible material may include, but not limited to, biocompatible materials such as elastomers, thermoplastic polyurethane elastomers such as Tecothane (Lubrizol Advanced Materials Inc., Wickliffe, Ohio), ultra high molecular weight polyethylene (UHMWPE), polycarbonate urethane (Sulene-PCU), polyethylene terephtalate (Sulene-PET), hydrogels (including with a polyethylene jacket), polyvinyl alcohol hydrogel (Aquarelle) and polycarbonate urethane elastomer (Newcleus) alone or in combination with other materials.
- biocompatible materials such as elastomers, thermoplastic polyurethane elastomers such as Tecothane (Lubrizol Advanced Materials Inc., Wickliffe, Ohio), ultra high molecular weight polyethylene (UHMWPE), polycarbonate urethane (Sulene-PCU), polyethylene terephtalate (Sulene-PET), hydrogels
- an interbody device includes top and bottom shells of a first material and an inner dampener of second dampening material.
- top and bottom shells comprise a carbon fiber reinforced PEEK material and the inner dampener material of a thermoplastic polyurethane elastomer.
- a plurality of shell components may be coupled with an inner dampener material.
- an inner dampener may comprise a mechanical spring and like compressible components of various materials.
- an interbody device of the invention may be an ellipsoid, including but not limited to a sphere, oblate spheroid, prolate spheroid and scalene ellipsoids.
- an interbody device may compromise a partial ellipsoid, partial polyhedrons and other shapes configured to include top and bottom curved surface portions for contacting vertebral bodies.
- an interbody device includes an inner dampener having one or more ellipsoidal compressible core portions and a compressible equatorial planar surface portion extending outwardly from the core.
- a pillar support may extend outward from one or more ellipsoidal core portions of the inner dampener.
- one or more pillar supports may include a head with a larger diameter than a pillar, wherein the head couples within a complimentary receiving portion of an outer shell such that one or more heads secure the inner dampeners and its components, such as an equatorial planar surface portion, one or more compressible ellipsoidal core portions and one or more pillars, within the inner body device.
- compressible and rigid materials may be combined through coupling means including, but not limited to, molding including overmolding and injection molding, press-fitting, adhesives, mechanical fastening and the like.
- an interbody device of the present invention may be adapted for interbody fusion procedures to provide improved stabilization, stress-shielding and maintenance of placement in the interbody space.
- an interbody device of the present invention may be adapted for interbody non-fusion procedures to provide dynamic stabilization, stress-shielding, reduced movement, reduced likelihood of escape and reduced subsidence.
- FIG. 1 is a front plan view of a spherical interbody device in one embodiment of the present invention.
- FIG. 2 is a top plan view plan view of a spherical interbody device in one embodiment of the present invention.
- FIG. 3 is a bottom plan view of a spherical interbody device in one embodiment of the present invention.
- FIG. 4 is a front perspective view of a spherical interbody device in one embodiment of the present invention.
- FIG. 5 a cross-sectional perspective view along Section A-A of FIG. 1 in one embodiment of the present invention.
- FIG. 6 is a cross-sectional perspective view along Section B-B of FIG. 1 in one embodiment of the present invention.
- FIG. 7 is a cross-sectional perspective view along Section C-C of FIG. 1 in one embodiment of the present invention.
- FIG. 8 is an exploded view of a spherical interbody device in one embodiment of the present invention.
- FIG. 9 is a bottom plan view of top outer shell of a spherical interbody device in one embodiment of the present invention.
- FIG. 10 is a front plan view of an inner dampener of a spherical interbody device in one embodiment of the present invention.
- FIG. 11 is a perspective view of an inner dampener of a spherical interbody device in one embodiment of the present invention.
- the present invention provides an apparatus for disc nucleus replacement to promote the support and absorption of axial loads while limiting subsidence and endplate erosion in both vertebral fusion and non-fusion spinal treatments.
- the combination of rigid and compressible components with curved surface portions, including a smooth outer surface in embodiments is adapted for placement and contacting the vertebral bodies to promote motion preservation and dynamic stabilization.
- an interbody device 10 of the invention in various embodiments supports spinal loads of preferably over 700 pounds and up to 1000 pounds without damage or disadvantageous alteration of the interbody device 10 .
- an interbody device 10 in one embodiment of the invention is a spherical shape.
- the device 10 includes a top outer shell 102 , a bottom outer shell 104 and an inner dampener 200 .
- the outer shells 102 and 104 may comprise sphere portions adapted to couple to inner dampener 200 .
- the top outer shell 102 and bottom outer shell 104 may be identical in size and shape. In other embodiments the shells 102 and 104 may be differently sized or shaped.
- the outer shells may comprise relatively rigid biocompatible materials, including, but not limited to, PEEK or carbon fiber reinforced PEEK (such as PEEK-Optima), titanium, stainless steel, cobalt chromium and the like, either alone or in combination with these or other materials.
- the outer shells may include other rigid polymeric materials or other metal materials.
- shells 102 and 104 include a smooth outer surface generally free of a frictional texture and protrusions.
- inner dampener 200 is molded with a rim 210 as an equatorial planar surface portion coupled to convex ellipsoidal compressible core portions 220 .
- a pillar 230 extends to a head 240 .
- each head 240 includes a slanted face 250 of a cylindrical segment of head 240 .
- the rim 210 has a diameter of about 11 mm and is about 2 mm thick.
- the pillar 230 has a diameter of about 1.27 mm and heads 240 have a diameter of about 1.88 mm.
- faces 250 also provide a continuous, smooth outer surface in combination with the outer shells.
- the inner dampener 200 may comprise compressible material including, but not limited to, polyethylene, polycarbonate urethane (Sulene), polyethylene terephtalate (Sulene), HP-100 silicone elastomer, hydrogel with a polyethylene jacket, polyvinyl alcohol hydrogel (Aquarelle), polycarbonate urethane elastomer (Newcleus), thermoplastic polyurethane elastomer (such as Tecothane) or other elastomers, polymers, plastics or rubber-like substances, either alone or in combination with these or other materials.
- compressible material including, but not limited to, polyethylene, polycarbonate urethane (Sulene), polyethylene terephtalate (Sulene), HP-100 silicone elastomer, hydrogel with a polyethylene jacket, polyvinyl alcohol hydrogel (Aquarelle), polycarbonate urethane elastomer (Newcleus), thermoplastic polyurethane elastomer (such as Te
- inner dampener material exhibits the following characteristics: (i) compliant enough to substantially reduce indentation into the vertebrae and (ii) stiff enough to keep an outer shell from breaking.
- an interbody device 10 of the present invention will undergo compressive deformation during daily activities and restore itself to near its original form each day during typical daily rest, including at least 98% daily restoration in one embodiment.
- an interbody device 10 of the present invention includes a creep modulus that changes by less than 20% in ten years at 37° C.
- an interbody device 10 is injection moldable, such as a thermoplastic or thermoset.
- the inner dampener 200 comprises Tecothane brand thermoplastic polyurethane elastomer and the outer shells comprise PEEK-Optima brand carbon fiber reinforced PEEK.
- each of outer shells 102 and 104 include a complimentary internal structure to the inner dampener 200 .
- Two crossing ribs 110 segment the internal structure of an outer shell into four concave seating portions 120 that each seat a convex portion 220 of the inner dampener 200 .
- Each seating portion 120 communicates with walled portion 117 of a cylindrical segment of the opening 115 .
- Walled portion 117 is complimentary to inner dampener heads 240 that fill the opening 115 and the head faces 250 provide portions of the contoured outer surface of the device 10 with outer shells 102 and 104 .
- ribs 110 are about 1.27 mm thick and the outer shells have a thickness of about 2.03 mm.
- cross-sectional views of assembled interbody device 10 depict the internal molding of inner dampener 200 to shells 102 and 104 .
- Circular rim 210 extends through the middle of interbody device 10 along section A-A ( FIG. 5 ) that depicts the center of the interbody device 10 and between segments 220 .
- FIG. 6 shows segments 220 and rim 210 within shells 102 and 104 along section B-B which cross-sections interbody device 10 outward from its center and before pillars 230 and heads 240 .
- section C-C provides a cross-section through two top and two bottom openings 115 moving further outward through the interbody device 10 from sections B-B and A-A.
- rim 210 , convex portions 230 and heads 240 with faces 250 are shown molded within shells 102 and 104 .
- interbody device 10 may have diameters of various sizes, including ranging from about 6 to about 18 mm, although such sizes may be adapted to the particular patient or purpose. In one embodiment, the interbody device has a spherical diameter of about 11 mm.
- an interbody device 10 may be constructed as one piece or assembled as a unit.
- overmolding processes including but not limited to injection and/or insert molding, may be used to couple an inner dampener 200 and outer shell materials.
- press-fitting, adhesives, mechanical fastening and like coupling means may be used.
- a mechanical spring or similarly compressible apparatus may be provided in place of or complimentary to an inner dampener 200 or compressible material.
- a molding method for manufacturing an interbody device 10 of the invention. Initially, outer shells 102 and 104 are each injection molded in a mold cavity. Next, shells 102 and 104 are placed into a different mold cavity for creating the inner dampener 200 . The dampener 200 is molded with and into the two shells 102 and 104 . Finally, the rim 210 is molded onto the three-piece molded assembly in yet another mold cavity. In such embodiment, the interbody device 10 is a four-piece, fully molded-together assembly.
- a trimming process may also be utilized where external molding support pegs (not shown) are also used to stabilize the outer shells 102 and 104 during manufacture.
- a peg may be added to the outside of each shell 102 and 104 on the center surface between openings 115 . Such peg holds each shell half in the mold cavity before and during the molding of the compliant inner dampener material. Such pegs may also hold the shell-dampener sub-assembly in the mold for the molding of the rim 210 .
- a support peg is 3.68 mm long with an elliptical shape and a middle cross-section area equivalent to a cylindrical peg of diameter of 1.04 mm. The supports pegs are trimmed off in the finishing of the interbody device 10 , including in embodiments where the outer surface of the interbody device 10 is made smooth.
Abstract
A spinal interbody device includes a compliant inner dampener in combination with a rigid outer material of outer shells. An inner dampener includes a rim with pillars and heads coupled to a complimentary inner structure of the outer shells.
Description
- This application is a continuation-in-part of U.S. patent application Ser. No. 12/134,946 filed Jun. 6, 2008, which claims priority to U.S. provisional patent application Ser. No. 60/942,802 filed Jun. 8, 2007, all of which are relied on and incorporated by reference.
- The present invention relates to fusion and non-fusion spinal interbody devices.
- Spinal interbody devices such as the Fernstrom ball developed by Dr. Ulf Fernstrom, the Harmon Spinal Sphere of the Austenal Company (New York, N.Y.) and the more recent Satellite Spinal System of Medtronic Sofamar Danek (Memphis, Tenn.) have attempted stabilization in a disc interspace with an insertable solid sphere. Because of the rigidity and lack of compression of such solid spheres, undesirable subsidence of the device may result leading to possible nerve agitation and further corrective surgery.
- Nucleus propulsus replacement has also been attempted with non-rigid hydrogels, such as disclosed in U.S. Pat. No. 7,214,245 to Marcolongo et al. Such hydrogels, however, are prone to migration and escape from the interbody space.
- Accordingly, a need exists for a compressible spinal interbody device that avoids the problems of interbody devices that are either too rigid or too yielding.
- In embodiments, the present invention answers this need by providing an interbody device with both rigid and compressible components for both supporting and absorbing axial loads while limiting subsidence and endplate erosion. The compressible components include material of greater compressibility than material of rigid components.
- In one embodiment, rigid material may include, but is not limited to, biocompatible materials such as polyetheretherketone (PEEK), carbon fiber reinforced PEEK such as PEEK-Optima (Invibio, Inc., West Conshohocken, Pa.) and other biocompatible polymeric materials. In further embodiments, rigid material may include biocompatible metals, including without limitation titanium, stainless steel and cobalt chromium alone or in combination with other materials. In further embodiments, the compressible material may include, but not limited to, biocompatible materials such as elastomers, thermoplastic polyurethane elastomers such as Tecothane (Lubrizol Advanced Materials Inc., Wickliffe, Ohio), ultra high molecular weight polyethylene (UHMWPE), polycarbonate urethane (Sulene-PCU), polyethylene terephtalate (Sulene-PET), hydrogels (including with a polyethylene jacket), polyvinyl alcohol hydrogel (Aquarelle) and polycarbonate urethane elastomer (Newcleus) alone or in combination with other materials.
- In embodiments of the invention, an interbody device includes top and bottom shells of a first material and an inner dampener of second dampening material. In one embodiment, top and bottom shells comprise a carbon fiber reinforced PEEK material and the inner dampener material of a thermoplastic polyurethane elastomer.
- In some embodiments, a plurality of shell components may be coupled with an inner dampener material.
- In alternative embodiments, an inner dampener may comprise a mechanical spring and like compressible components of various materials.
- In one embodiment, an interbody device of the invention may be an ellipsoid, including but not limited to a sphere, oblate spheroid, prolate spheroid and scalene ellipsoids. In other embodiments of the invention an interbody device may compromise a partial ellipsoid, partial polyhedrons and other shapes configured to include top and bottom curved surface portions for contacting vertebral bodies.
- In some embodiments, an interbody device includes an inner dampener having one or more ellipsoidal compressible core portions and a compressible equatorial planar surface portion extending outwardly from the core.
- In some embodiments, a pillar support may extend outward from one or more ellipsoidal core portions of the inner dampener. In further embodiments one or more pillar supports may include a head with a larger diameter than a pillar, wherein the head couples within a complimentary receiving portion of an outer shell such that one or more heads secure the inner dampeners and its components, such as an equatorial planar surface portion, one or more compressible ellipsoidal core portions and one or more pillars, within the inner body device.
- In embodiments of the invention, compressible and rigid materials may be combined through coupling means including, but not limited to, molding including overmolding and injection molding, press-fitting, adhesives, mechanical fastening and the like.
- In embodiments of the invention, an interbody device of the present invention may be adapted for interbody fusion procedures to provide improved stabilization, stress-shielding and maintenance of placement in the interbody space. In other embodiments an interbody device of the present invention may be adapted for interbody non-fusion procedures to provide dynamic stabilization, stress-shielding, reduced movement, reduced likelihood of escape and reduced subsidence.
-
FIG. 1 is a front plan view of a spherical interbody device in one embodiment of the present invention. -
FIG. 2 is a top plan view plan view of a spherical interbody device in one embodiment of the present invention. -
FIG. 3 is a bottom plan view of a spherical interbody device in one embodiment of the present invention. -
FIG. 4 is a front perspective view of a spherical interbody device in one embodiment of the present invention. -
FIG. 5 a cross-sectional perspective view along Section A-A ofFIG. 1 in one embodiment of the present invention. -
FIG. 6 is a cross-sectional perspective view along Section B-B ofFIG. 1 in one embodiment of the present invention. -
FIG. 7 is a cross-sectional perspective view along Section C-C ofFIG. 1 in one embodiment of the present invention. -
FIG. 8 is an exploded view of a spherical interbody device in one embodiment of the present invention. -
FIG. 9 is a bottom plan view of top outer shell of a spherical interbody device in one embodiment of the present invention. -
FIG. 10 is a front plan view of an inner dampener of a spherical interbody device in one embodiment of the present invention. -
FIG. 11 is a perspective view of an inner dampener of a spherical interbody device in one embodiment of the present invention. - The present invention provides an apparatus for disc nucleus replacement to promote the support and absorption of axial loads while limiting subsidence and endplate erosion in both vertebral fusion and non-fusion spinal treatments. In non-fusion embodiments, the combination of rigid and compressible components with curved surface portions, including a smooth outer surface in embodiments, is adapted for placement and contacting the vertebral bodies to promote motion preservation and dynamic stabilization.
- Although the invention is described in spherical embodiments, it will be appreciated that other ellipsoid shapes (including other spheroids) and still further various shapes that include curved surface portions configured to contact a vertebrae may be provided in other embodiments. The shaping, internal geometry and materials of an
interbody device 10 of the invention in various embodiments supports spinal loads of preferably over 700 pounds and up to 1000 pounds without damage or disadvantageous alteration of theinterbody device 10. - Referring to
FIGS. 1-4 and 8, aninterbody device 10 in one embodiment of the invention is a spherical shape. Thedevice 10 includes a topouter shell 102, a bottomouter shell 104 and aninner dampener 200. Theouter shells inner dampener 200. In some embodiments the topouter shell 102 and bottomouter shell 104 may be identical in size and shape. In other embodiments theshells shells - With continuing reference to
FIG. 8 and further reference toFIGS. 10 and 11 , in one embodiment of the inventioninner dampener 200 is molded with arim 210 as an equatorial planar surface portion coupled to convex ellipsoidalcompressible core portions 220. From each convex portion 220 apillar 230 extends to ahead 240. In one embodiment of the invention, eachhead 240 includes aslanted face 250 of a cylindrical segment ofhead 240. In one embodiment, therim 210 has a diameter of about 11 mm and is about 2 mm thick. Thepillar 230 has a diameter of about 1.27 mm andheads 240 have a diameter of about 1.88 mm. In embodiments the greater diameter of theheads 240 compared to thepillars 230 promotes securing theinner dampener 200 withinouter shells faces 250 also provide a continuous, smooth outer surface in combination with the outer shells. - The
inner dampener 200 may comprise compressible material including, but not limited to, polyethylene, polycarbonate urethane (Sulene), polyethylene terephtalate (Sulene), HP-100 silicone elastomer, hydrogel with a polyethylene jacket, polyvinyl alcohol hydrogel (Aquarelle), polycarbonate urethane elastomer (Newcleus), thermoplastic polyurethane elastomer (such as Tecothane) or other elastomers, polymers, plastics or rubber-like substances, either alone or in combination with these or other materials. In embodiments, inner dampener material exhibits the following characteristics: (i) compliant enough to substantially reduce indentation into the vertebrae and (ii) stiff enough to keep an outer shell from breaking. In embodiments, aninterbody device 10 of the present invention will undergo compressive deformation during daily activities and restore itself to near its original form each day during typical daily rest, including at least 98% daily restoration in one embodiment. In one embodiment of the invention aninterbody device 10 of the present invention includes a creep modulus that changes by less than 20% in ten years at 37° C. In embodiments of the invention, aninterbody device 10 is injection moldable, such as a thermoplastic or thermoset. - In one embodiment, the
inner dampener 200 comprises Tecothane brand thermoplastic polyurethane elastomer and the outer shells comprise PEEK-Optima brand carbon fiber reinforced PEEK. - With reference to
FIG. 9 , in embodiments of the invention each ofouter shells inner dampener 200. Two crossingribs 110 segment the internal structure of an outer shell into fourconcave seating portions 120 that each seat aconvex portion 220 of theinner dampener 200. Eachseating portion 120 communicates withwalled portion 117 of a cylindrical segment of theopening 115.Walled portion 117 is complimentary to inner dampener heads 240 that fill theopening 115 and the head faces 250 provide portions of the contoured outer surface of thedevice 10 withouter shells - In one embodiment,
ribs 110 are about 1.27 mm thick and the outer shells have a thickness of about 2.03 mm. - Referring to
FIGS. 5-7 , and further reference toFIG. 1 , cross-sectional views of assembledinterbody device 10 depict the internal molding ofinner dampener 200 toshells Circular rim 210 extends through the middle ofinterbody device 10 along section A-A (FIG. 5 ) that depicts the center of theinterbody device 10 and betweensegments 220.FIG. 6 showssegments 220 andrim 210 withinshells interbody device 10 outward from its center and beforepillars 230 and heads 240. InFIG. 7 section C-C provides a cross-section through two top and twobottom openings 115 moving further outward through theinterbody device 10 from sections B-B and A-A. Along section C-C,rim 210,convex portions 230 and heads 240 withfaces 250 are shown molded withinshells - In embodiments of the invention,
interbody device 10 may have diameters of various sizes, including ranging from about 6 to about 18 mm, although such sizes may be adapted to the particular patient or purpose. In one embodiment, the interbody device has a spherical diameter of about 11 mm. - In various embodiments of the present invention an
interbody device 10 may be constructed as one piece or assembled as a unit. In some embodiments of the invention, overmolding processes, including but not limited to injection and/or insert molding, may be used to couple aninner dampener 200 and outer shell materials. In other embodiments, press-fitting, adhesives, mechanical fastening and like coupling means may be used. In alternative embodiments, a mechanical spring or similarly compressible apparatus may be provided in place of or complimentary to aninner dampener 200 or compressible material. - In one embodiment, a molding method is provided for manufacturing an
interbody device 10 of the invention. Initially,outer shells shells inner dampener 200. Thedampener 200 is molded with and into the twoshells rim 210 is molded onto the three-piece molded assembly in yet another mold cavity. In such embodiment, theinterbody device 10 is a four-piece, fully molded-together assembly. - In embodiments, a trimming process may also be utilized where external molding support pegs (not shown) are also used to stabilize the
outer shells shell openings 115. Such peg holds each shell half in the mold cavity before and during the molding of the compliant inner dampener material. Such pegs may also hold the shell-dampener sub-assembly in the mold for the molding of therim 210. In one embodiment, a support peg is 3.68 mm long with an elliptical shape and a middle cross-section area equivalent to a cylindrical peg of diameter of 1.04 mm. The supports pegs are trimmed off in the finishing of theinterbody device 10, including in embodiments where the outer surface of theinterbody device 10 is made smooth. - While the invention has been described with reference to structures and methods in some embodiments of the invention, the invention is not intended to be limited thereto, but extends to modifications and improvements within the scope or equivalence of the claims.
Claims (15)
1. An interbody device comprising a first curved vertebral body contact surface, a second curved vertebral body contact surface opposite the first vertebral body contact surface and an inner dampener having at least one convex core portion with a pillar extending outward toward an outer surface of the interbody device from the at least one convex core portion.
2. The interbody device of claim 1 , wherein said pillar terminates at a head having a greater diameter than the pillar.
3. The interbody device of claim 2 , wherein the interbody device is an ellipsoidal shape.
4. The interbody device of claim 3 , wherein said ellipsoidal shape is a sphere.
5. The interbody device of claim 4 , further comprising an upper outer shell and a bottom outer shell coupled to the inner dampener.
6. The interbody device of claim 5 , wherein the inner dampener includes an equatorial planar surface portion providing a thickness at a middle segment of the interbody device.
7. The interbody device of claim 1 , wherein the inner dampener includes an equatorial planar surface portion providing a thickness at a middle segment of the interbody device.
8. The interbody device of claim 2 , wherein the inner dampener includes an equatorial planar surface portion providing a thickness at a middle segment of the interbody device.
9. The interbody device of claim 3 , wherein the inner dampener includes an equatorial planar surface portion providing a thickness at a middle segment of the interbody device.
10. The interbody device of claim 4 , wherein the inner dampener includes an equatorial planar surface portion providing a thickness at a middle segment of the interbody device.
11. The interbody device of claims 1 -10, wherein the first and second curved vertebral contact surfaces each include polyetheretherketone molded to the inner dampener including thermoplastic polyurethane elastomer.
12. The interbody device of claims 1 -10, wherein the first and second curved vertebral contact surfaces each include carbon reinforced polyetheretherketone molded to the inner dampener including thermoplastic polyurethane elastomer.
13. An interbody device comprising a smooth, ellipsoidal outer surface of rigid polymeric material molded to an elastomeric inner dampener.
14. The interbody device of claim 13 wherein the rigid polymeric material includes polyetheretherketone and the elastomeric inner dampener includes thermoplastic polyurethane elastomer.
15. The interbody device of claim 13 wherein the rigid polymeric material includes carbon fiber reinforced polyetheretherketone and the elastomeric inner dampener includes thermoplastic polyurethane elastomer.
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US20150032210A1 (en) * | 2013-07-26 | 2015-01-29 | Warsaw Orthopedic, Inc. | Interbody implant and method |
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US9144502B1 (en) | 2015-09-29 |
US9114021B2 (en) | 2015-08-25 |
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