WO2006019370A1 - Disque intervertébral artificiel - Google Patents
Disque intervertébral artificiel Download PDFInfo
- Publication number
- WO2006019370A1 WO2006019370A1 PCT/US2004/022778 US2004022778W WO2006019370A1 WO 2006019370 A1 WO2006019370 A1 WO 2006019370A1 US 2004022778 W US2004022778 W US 2004022778W WO 2006019370 A1 WO2006019370 A1 WO 2006019370A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- column
- anchor member
- intervertebral disc
- artificial intervertebral
- eptfe
- Prior art date
Links
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- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
- A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
- A61F2002/30884—Fins or wings, e.g. longitudinal wings for preventing rotation within the bone cavity
-
- 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
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/442—Intervertebral or spinal discs, e.g. resilient
- A61F2/4425—Intervertebral or spinal discs, e.g. resilient made of articulated components
- A61F2002/443—Intervertebral or spinal discs, e.g. resilient made of articulated components having two transversal endplates and at least one intermediate component
-
- 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
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2002/448—Joints for the spine, e.g. vertebrae, spinal discs comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
-
- 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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
-
- 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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0033—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
-
- 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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/005—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives
-
- 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
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0018—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in elasticity, stiffness or compressibility
Definitions
- the present invention is directed to the field of prosthetic devices. More particularly, one embodiment of the present invention is directed to an artificial disc that can be used as a replacement for an intervertebral disc (e.g., a human intervertebral lumbar disc, a human intervertebral cervical disc and/or a human intervertebral thoracic disc).
- an intervertebral disc e.g., a human intervertebral lumbar disc, a human intervertebral cervical disc and/or a human intervertebral thoracic disc.
- the term "column” (e.g., as in ePTFE column) is intended to refer to a solid, partially hollow or hollow structure having any desired aspect ratio and any desired cross-section (cross-sectional shape and/or cross-sectional area).
- a column may have a high length to width aspect ratio (i.e., the column may be "elongated”).
- such a column may have a low length to width aspect ratio (i.e., the column may be "squat").
- the walls of the column may be thick enough to provide a substantial degree of inflexibility to the column.
- the walls of the column may be thin enough to provide a substantial degree of flexibility to the column.
- such a column may have a cross-section which is circular, oval, square or "kidney-shaped".
- filler e.g., as in column filler
- filler is intended to refer to a substance disposed within a space or void which partially or fully fills the volume of the space or void.
- composite structure is intended to refer to a hollow or partially hollow column including a filler disposed therein.
- ePTFE is intended to refer to: (a) a PTFE material that has been expanded and sintered; or (b) a PTFE material that has been expanded, formed, attached to another material (e.g., fusion welded) and sintered.
- an artificial intervertebral disc (“AID") assembly comprised of first and second anchor plates (each of which has a vertebrae contacting side) and at least one composite structure that is fixed to the first and second anchor plates.
- the composite structure may be comprised of a column of expanded poly(tetraflouroethylene) (“ePTFE").
- ePTFE expanded poly(tetraflouroethylene)
- the column of ePTFE may be at least partially hollow (e.g., having one or more holes therein) and may be filled (fully or partially) with a compressible material, such as an elastomer.
- the elastomer may include a silicone, a urethane, a thermoplastic elastomer, an elastomer alloy; a polyurethane/polycarbonate -alloy, and/or any combination thereof.
- the column filler (e.g., elastomer) may store energy and then return the stored energy back to the physiological system (because the column filler (e.g., elastomer) may allow physiological-like displacement, the column filler (e.g., elastomer) may (like a physiological system) dissipate some strain energy).
- ePTFE is a material processed from PTFE polymer.
- ePTFE has a configuration (e.g., a network of nodes and fibrils) that imparts certain expandability, compressibility, and porosity properties to the ePTFE. More particularly, ePTFE is described in U.S. Patent No. 3,953,566 as follows "in the case of uniaxial expansion the nodes are elongated, the longer axis of a node being oriented perpendicular to the direction of expansion. The fibrils which interconnect the nodes are oriented parallel to the direction of expansion.
- fibrils appear to be characteristically wide and thin in cross-section, the maximum width being equal to about 0.1 micron (1000 angstroms) which is the diameter of the crystalline particles.
- the minimum width may be 1 or 2 molecular diameters or in the range of 5 or 10 angstroms.
- the nodes may vary in size from about 400 microns to less than a micron, depending on the conditions used in the expansion. Products which have been expanded at high temperatures and high rates have a more homogeneous structure, i.e. they have smaller, more closely spaced nodes and these nodes are interconnected with a greater number of fibrils. These products are also found to have much greater strength.” This patent is incorporated herein by reference.
- the network of nodes and fibrils of an ePTFE tubular structure allows axial compressive and extensive freedom, while at the same time, allowing relatively high radial strength. It is believed that when the ePTFE tubular structure is internally filled (e.g., with an elastomer), the composite structure presents very similar compressive load/deflection behavior to that of a healthy, intervertebral lumbar, thoracic, or cervical disc. That is, the amount of force needed to compress the ePTFE/elastomer composite structure, increases non-linearly. Further, ePTFE allows for both compression and extension locally within the same structural member, which mimics the behavior of an intervertebral disc in the modes of spinal extension, flexion, and lateral bending.
- a compressive coil spring resists deflection according to its spring constant, which establishes a linear relationship between applied load and reactive deflection. It is believed that this linear relationship largely holds true until the point at which adjacent coils of the spring begin to contact one another, a phenomenon called stacking. Once a spring begins to stack, the ability of the spring to compress becomes less and less, resulting in a greater and greater spring constant. When fully stacked, any further load applied is resisted according to the compressive elastic modulus of the spring material itself, not by the torsional properties of the continuous beam that makes up the coils.
- the in vivo disc exhibits a continuously increasing stiffness as compressive deflection is increased.
- This in vivo behavior of increasing spring constant can be mimicked by constraining the elastomeric material radially.
- the molecular stacking behavior of the "spring” occurs at lower loads and thus, is enhanced.
- this enhanced molecular stacking can be controlled, allowing a close match to the in vivo behavior of the intervertebral disc.
- ePTFE for example, as the constraining member allows for a material which can expand and contracx axiaiiy with the deflection of the clast ⁇ nici, while at the same time, maintaining an essentially consistent resistance to radial bulge (in other words, the ePTFE provides good "hoop strength").
- the compressive properties of the artificial intervertebral disc may be tuned to largely match those found in a natural intervertebral disc by utilizing a generally parabolic function.
- the AID assembly may be constructed of first and second anchor plates, each of which has a vertebrae contacting side, and a plurality of composite structures that are fixed to the first and second anchor plates.
- first and second anchor plates each of which has a vertebrae contacting side
- a plurality of composite structures that are fixed to the first and second anchor plates.
- 2-8 composite structures may be fixed to the anchor plates.
- the AID assembly may be provided with one or more anchor plates that have one or more undercuts and/or one or more tabs to facilitate the anchoring of the AID assembly to the vertebral bodies.
- the tabs may be provided with screw-holes into which bone screws can be inserted to anchor the assembly to the vertebral bodies.
- the screw holes and/or the tabs may be angled relative to the vertebrae bodies (e.g., to pull all or part of the AID assembly diagonally against the vertebrae).
- the anchor plates may be assembled such that the anchor plates are non-parallel (e.g., in order to provide a profile that substantially corresponds to the lordotic profile of the vertebral bodies/intervertebral space).
- the non- parallel angle may be about 5° to about 15°.
- a final AID assembly may be comprised of multiple assemblies (e.g., matching left and right assemblies), each assembly having first and second anchor plates and at least one composiie structure that is fixed to the anchor plates.
- the left and right assemblies may be sized and dimensioned to reside adjacent to each other when positioned in the space between vertebral bodies.
- compression ferrules may fix the composite structure to the anchor plates.
- the ferrules may be fitted inside the column of the composite structure and, as a result of the sizing of the ferrules relative to the sizing of the openings in the anchor plates, the ferrules may impinge against the inner wall of the column and force it outward against the walls of the anchor plates at their openings.
- ferrules may be expanded after fitting inside the column of the composite structure, such expansion being caused, for example, by the advancement of a tapered set screw or another tapered part within the ferrule.
- the inner wall of the column of the composite structure may be impinged upon to force it outward against the walls of the anchor plates by means of a tapered set screw or other tapered part advancing within the column and in direct contact with the inside wall of the column.
- one or more portions of the column of the composite structure may be formed into any appropriate shape (e.g., may be flared) and a compression flange affixed onto the anchor plate, trapping the ends of the column (e.g., once the column has been inserted through the anchor plates) in order to force the ends of the column axially into frictional engagement with the anchor plates.
- one or more portions of the column of the composite structure may be formed into any appropriate shape (e.g., may be flared or flanged such that the end portions of the column wall are reoriented in a plane essentially perpendicular to the longitudinal axis of the column). This may be accomplished by the application of heat and/or pressure to the end portions of the column wall. In one example (which example is intended to be illustrative and not restrictive), pressure may be applied via a fixture capable of stretching the column wall radially and then compressing the column wall axially.
- a compression flange affixed to the anchor plate may trap each end of the column (e.g., once the column has been inserted through the anchor plates).
- the compression flanges may axiaily force Lhe ends of the column int ⁇ planai fiicti ⁇ na ⁇ engagement with the anchor plates.
- one flanged or flared end of the column of the composite structure can be compressed against the bottom surface of the top anchor plate by a compression fit.
- the other flanged or flared end of the column of the composite structure can be compressed against the top surface of the bottom anchor plate by a compression fit.
- one flanged or flared end of the column of the composite structure can be compressed against the bottom surface of the top anchor plate by a capture ring.
- the other flanged or flared end of the column of the composite structure can be compressed against the top surface of the bottom anchor plate by a- capture ring.
- This capture ring can either be a unitary part, in which case the column of the composite structure may be inserted through the ring before being flared, or the capture ring can be two or more parts (e.g., separated roughly in half across a diameter) such that the ring may be assembled around the column near the flange before being assembled into the anchor plate, capturing the flange (e.g., after weld and sinter).
- the column of the composite structure e.g., the ePTFE column
- the capture ring may be treated (e.g., on one or both mating surfaces) to aid in creating a tight, high-friction fit.
- the AID assembly may be comprised of first and second anchor plates (e.g., top and bottom anchor plates) and at least one composite structure including a column (e.g., an ePTFE column) that is fixed to the anchor plates.
- a column e.g., an ePTFE column
- the ePTFE column prior to being sintered, may be engaged (for example, at each end) with a respective flange element (e.g., made from a pre-sintered or post- sintered compatible flouropolymer (e.g., FEP, PFA, or PTFE modified to enhance its bonding capabilities)).
- Each flange element may be, for example, a holed disc, similar to a washer.
- Each flange element may be brought into tight engagement with the ePTFE column, and then sintered as an assembly.
- a fixture that provides high pressure on the wall surface of the column and/or the flange element can be employed to enhance the engagement of the ePTFE column with the flange element.
- Each end of the column so produced i.e., including the engaged flange element
- the final assembly is believed to posses high connective strength at the inxerface of the engaged parts.
- the column of a composite structure may be bonded (e.g., physically or chemically bonded) to another element made, for example, from PTFE, ePTFE, modified PTFE (e.g., modified to enhance its bonding capabilities), or another compatible flouropolymer such as FEP or PFA, to form a composite flange.
- the ePTFE column may be heat-sealed, ultrasonically welded and/or fusion welded to another element made, for example, from PTFE, ePTFE, modified PTFE (e.g., modified to enhance its bonding capabilities), or another compatible flouropolymer such as FEP or PFA.
- the column of a composite structure may be impregnated with an elastomer (e.g., urethane or silicone) in order that the impregnated column can be bonded to another compatible structure, thus allowing for termination to the anchor plate.
- an elastomer e.g., urethane or silicone
- the column(s) of the composite structure(s) may be terminated (e.g., using any of the above described means) to intermediate end-pieces, which are then affixed to the anchor plates by one or more of a variety of means, thus allowing for interchangeable heights and stiffnesses to provide a custom device for a patient's specific needs.
- Such customization may be provided, for example (which example is intended to be illustrative and not restrictive), via use of screw(s), threaded mechanism(s), and/or various sized insert(s) or ring(s).
- making a portion of the column of the composite structure relatively hard may aid in attaching the column of the composite structure to the anchor plates (e.g., a hard material may not have to be clamped down on as hard as a softer material).
- each AID assembly of the present invention may be inserted using any desired surgical approach.
- a posterior approach may be utilized.
- a posterior, lateral approach may be utilized.
- an anterior approach may be utilized.
- Figure 1 shows a cross sectional view of an AID assembly according to an embodiment of the present invention
- Figure 2A shows a side elevation view along one side of an AID assembly according to an embodiment of the present invention
- Figure 2B shows a cross sectional view of an AID according to an embodiment of the present invention
- Figure 2C shows a side elevation view along another side of an AID assembly according to an embodiment of the present invention
- Figure 2D shows a perspective view of an AID assembly according to an embodiment of the present invention
- Figure 2E shows a top plan view of an AID assembly according to an embodiment of the present invention.
- Figure 3 A shows a side elevation view along one side of an AID assembly according to an embodiment of the present invention
- Figure 3B shows a side elevation view along another side of an AID assembly according to an embodiment of the present invention
- Figure 3C shows a perspective view of an AID assembly according to an embodiment of the present invention
- Figure 3D shows a top plan view of an AID assembly according to an embodiment of the present invention.
- Figure 4A shows a side elevation view along one side of an AID assembly according to an embodiment of the present invention
- Figure 4B shows a cross sectional view of an AID assembly according to an embodiment of the present invention
- Figure 4C shows a side elevation view along another side of an AID assembly according to an embodiment of the present invention.
- Figure 4D shows a perspective view of an AID assembly according to an embodiment of the present invention
- Figure 4E shows a top plan view of an AID assembly according to an embodiment of the present invention
- Figure 5A shows a side elevation view along one side of an AID assembly according to an embodiment of the present invention
- Figure 5B shows a cross sectional view of an AID assembly according to an embodiment of the present invention
- Figure 5C shows a side elevation view along another side of an AID assembly according to an embodiment of the present invention.
- Figure 5D shows a perspective view of an AID assembly according to an embodiment of the present invention
- Figure 5E shows a top plan view of an AID assembly according to an embodiment of the present invention.
- Figure 6 shows a side elevational view of another embodiment of the present invention in which the AID assembly is comprised of a pair of implant components
- Figure 7 shows a cross sectional view of a component of an AID assembly according to an embodiment of the present invention
- Figure 8 shows a perspective view of another embodiment of the present invention in which the AID assembly is comprised of a pair of implant components
- Figure 9 shows a cross sectional view of another embodiment of the present invention in which the AID assembly utilizes a "dome-core-dome" internal configuration
- Figure 1OA shows a cross sectional view of the AID assembly of Figure 9 (disposed between two vertebrae);
- Figure 1OB shows an elevational view of the AID assembly of Figure 9 (disposed between two vertebrae);
- Figure 1OC shows a cross sectional view of an AID assembly (disposed between two vertebrae);
- Figure 1OD shows an elevational view of the AID assembly of Figure 1OC (disposed between two vertebrae);
- Figure 1OE shows a cross sectional view of the AID assembly of Figure 1OC (disposed between two vertebrae);
- Figure 11 shows a perspective view of certain interior parts of Figure 9
- Figures 12A and 12B show a schematic view of an interior interface between parts of Figure 9 (see Figure 12A) and a schematic view of another embodiment of the interface (see Figure 12B);
- Figure 13 shows a perspective view of the exterior of the AID assembly of Figure 9;
- Figure 14 shows a perspective view of ihe AID assembly of Figme 9 (inserted between two vertebrae);
- Figure 15 shows a cross sectional view of an ePTFE column according to an embodiment of the present invention
- Figures 16A and 16B show another embodiment of the present invention (Figure 16A is cross sectional view and Figure 16B is an elevation view);
- Figures 17A and 17B show another embodiment of the present invention (Figure 17A is a top view and Figure 17B is a side view);
- Figures 18A-18C show another embodiment of the present invention (Figure 18A is a top view, Figure 18B is a side view, and Figure 18C is a perspective view);
- Figures 19A and 19B show another embodiment of the present invention (Figure 19A is a top view and Figure 19B is a side view);
- FIGS 20A-20E show other embodiments of the present invention.
- FIGS 21 A-20C show other embodiments of the present invention.
- FIGS 22A-22E show other embodiments of the present invention.
- FIGS 23 A and 23B show other embodiments of the present invention.
- Figure 24 shows another embodiment of the present invention.
- FIGS 25A-25C and 26A-26C show other embodiments of the present invention.
- FIG. 27 shows another embodiment of the present invention
- FIGS 28 A and 28B show other embodiments of the present invention.
- FIGS. 29A and 29B show other embodiments of the present invention.
- FIGS 30A-30C show other embodiments of the present invention.
- FIGS 31A-31C show other embodiments of the present invention.
- Figures 32A and 32B show other embodiments of the present invention.
- FIGS 33A-33C show other embodiments of the present invention.
- the AID of the present invention may be comprised of one or more components or assemblies.
- certain Figures show views of assemblies which may be combined (as shown in Figure 8, for example) to produce a final artificial intervertebral disc-
- AID assembly 10 is comprised of a first anchor plate 12 and a second anchor plate 14, between which is disposed column 16.
- Column 16 (which is formed of ePTFE) includes therein column filler 17 (which is formed of an elastomer).
- Anchor plate 12 includes a mechanism (threaded fastener 19a) for attachment to a vertebral body 19b.
- anchor plate 14 includes a mechanism (threaded fastener 19c) for attachment to a vertebral body 19d.
- the AID 10 has a first anchor plate 12, a second anchor plate 14 (both of which may be constructed of titanium, for example), and columns 16, 18 which are constructed of ePTFE.
- the columns 16, 18 (including therein respective column fillers) serve as spacer elements between the anchor plates 12, 14.
- the end surface 32 of columns 16, 18 terminate flush at the top surface 34 of anchor plate 12 (as well as flush at the bottom surface of anchor plate 14, which configuration is not shown in this view).
- the outer diameter of the column lies against the inner diameter of the opening in the anchor plate.
- a compression ferrule 20, 22 is placed within the column at an end thereof, as shown in Figure 2B.
- the ferrule is sized to form a snug fit between the ferrule, column, and sidewalls defining the opening of the anchor plate. This forms a firm frictional engagement between the components that locks the columns in place.
- the ends of the columns may be flared and a compression flange affixed onto the anchor plate, trapping the ends of the column (once the column has been inserted through the anchor plates) in order to force the ends of the column axially into frictional engagement with the anchor plates.
- the ends of the column 16a are flared after extending through the thickness of the anchor plate such that the outer wall of the column lies against the top surface of the anchor plate 12 and the inner wall of the column faces outward axially.
- a compression flange 21 is affixed to the top surface of the anchor plate, forming a snug fit between the flange, column, and upper surface of the anchor plate.
- the flange 21 may be fixed to the anchor plate 12 by securing screws through bores provided in the flange and the anchor plate, or by another suitable arrangement, such as by passing bolts through bores provided in the flange and the anchor plate and securing the bolts with washers and nuts.
- a slit may be provided at the end of the column, which could facilitate its flaring.
- the anchor plate which is elevated beyond the surface, which elevated portion contacts the vertebral endplate.
- This elevated portion of the anchor plate may be the interface between the anchor plate and the vertebral body.
- the elevated interface may reside in a corresponding depression or groove formed in the vertebral endplate.
- the elevated interface may be furnished with an undercut 35, 36 to provide a dovetail fit between the anchor plate and the depression or groove that is formed in the vertebral body.
- the undercut 35, 36 may run linearlv down the sides of the elevated portion, as in Figures 2A-2E.
- the undercut 35, 36 may run down the center of the plate, as shown in Figures 4A-4E, in a configuration, which in its cross section (see Figure 4C ) resembles a light bulb, with a neck portion and a bulbous portion.
- the undercut 35,36 may pass around the perimeter of the opening in the anchor plate, such as the daisy wheel configuration of Figures 3A-3D, or intersect linearly with a truncated daisy wheel configuration as m Figures 5A-5E.
- the elevated interface may be provided on the anchor plate in order to form an interface between the vertebral bodies and the surface of the anchor plates. That is, over a period of time, the vertebral bodies may grow around the interface on each of the anchor plates, forming a complementary arrangement, which anchors the implant in place.
- the surgeon may make the requisite incisions or access the site where the unhealthy or damaged disc is to be removed.
- the surgeon may cut grooves in the endplates of the vertebral bodies that were adjacent to the removed disc.
- the grooves that are cut may be sized and shaped to correspond to the interface on the elevated portion of the anchor plate.
- the surgical procedure may also involve removing healthy portion(s) of the patient's disc(s) to the extent required for implantation of the AID assembly.
- the compressibility of the implant of the present invention may prove helpful during the implanting procedure.
- the implant may be compressed to smaller proportions than its uncompressed height. The surgeon can then, prior to releasing the implant from its compressed height, adjust its position to insure that the elevated interface on the anchor plates and the grooves cut into the vertebral bodies are aligned with each other. After the surgeon has ensured this is the case, the implant may be released from its compressed state, so that the elevated interface enters the grooves.
- the grooves may be cut in the vertebral body with a matching undercut, such that the anchor plates may be inserted (e.g., from the side, front or back) in a dovetail configuration.
- This embodiment may allow for positive initial tensile attachment between the anchor plates and the endplates, without having to wait for bony ingrowth.
- the anchor plates may be disposed in a non-parallel configuration (in order to account for the lordotic angle of the vertebrae/intervertebral space, for example). This may help insure that the surface of the anchor plate will contact a respective surface of the vertebral bodies to the fullest possible extent.
- An AID constructed in this manner may exhibit behavior similar to that of the original disc, which also reflected the lordotic angle between vertebral bodies/intervertebrai space.
- the angle may lie in the range of about 5° to about 15°, which (it is believed) should cover the lordotic angles of the vertebral bodies/intervertebrai space of most of the population.
- anchor plate edges 38 and 39 may form angle ⁇ .
- This angle may be provided to account for the angle at which the device enters the body. That is, the angle may be provided as a design feature in order to facilitate installation by particular approach, such as a posterior lateral approach, for example.
- the device may be designed to have a preselected angle ⁇ that facilitates a particular approach to installation.
- FIG. 6 shows another embodiment of the present invention in which the AID is comprised of a pair of implant components (or assemblies) 10a,10b.
- Each component (or assembly) 1Oa 5 IOb is provided with anchor plates 12a, 14a, 12b, 14b, and columns 16, 18, fixed to the anchor plates in the manners previously discussed (respective column filler elements, not shown, may also be used).
- the implant components (or assemblies) may be provided with complementary, matching or corresponding lordotic profiles and may be intended to sit in front of and behind one another (as in this Figure 6). In other embodiments the components (or assemblies) may be intended to sit laterally adjacent to each other. This arrangement may provide flexibility 'in the insertion process, allowing one component to be inserted from each side of the spinal cord, for example.
- FIG 8 shows another embodiment of the present invention in which the implant is comprised of a pair of implant components (or assemblies) 10a,10b.
- Each component (or assembly) 10a,10b is provided with anchor plates 12a, 14a, 12b, 14b, and columns 16a, 18a, 16b, 18b fixed to the anchor plates in the manners previously discussed (respective column filler elements, not shown, may also be used).
- the implant components (or assemblies) may be provided with matching or corresponding lordotic profiles and may be intended to sit laterally adjacent to each other and/or in front of and behind one another. This arrangement may provide flexibility in the insertion process, allowing one component to be inserted from each side of the spinal cord, for example.
- this Figure 3 shows an embodiment comprised of one component (or assembly) similar to the one shown in the views of Figures 5A-5E and another component (or assembly) also similar to the one shown in the views of Figures 5A-5E, but with an essentially mirror-image configuration.
- Multi-component (or multi-assembly) implants corresponding to embodiments shown in the other Figures are, of course, also contemplated by the present invention.
- the perimeters of the anchor plates may be provided with tabs 24, 26.
- the tabs 24, 26 may extend at an angle substantially normal to the plane of the anchor plates.
- the tabs may also extend at an angle relative to this normal plane in order that the relation between the tab and the anchor plate more closely resembles that relation between the vertebral endplate and the substantially vertical outer surface of the vertebral body.
- the tabs 24, 26 may have an outer surface and an imier surface that faces in toward the anchor plates.
- the tabs 24,26 may aid in attaining the correct positioning of the implant relative to the vertebral bodies it is positioned between.
- the correct position may be attained when the inner surface of the tabs 24, 26 lie substantially flush against the outer surface of the vertebral bodies.
- the tabs 24, 26 may be provided with through bores, through which fixation devices, such as bone screws, may be inserted in order to lock the implant in place.
- AID assembly 900 is comprised of a first anchor plate 912 and a second anchor plate 914, between which is disposed column 916.
- Column 916 (which is formed of ePTFE) includes therein elastomer core 917.
- Column 916 may be attached to first anchor plate 912 and a second anchor plate 914 using any of the mechanisms described in the present application (in the example shown in this Figure 9, the ePTFE at each end of the column 916 is flared, welded to flange 920a and captured behind capture ring 920b).
- Anchor plate 912 includes a mechanism (throughbore 912a) to aid in attachment to a vertebral body (not shown) by using a fastener (not shown).
- anchor plate 914 includes a mechanism (throughbore 914a) to aid in attachment to a vertebral body (not shown) by using a fastener (not shown).
- the throughbores may include fastener mounting features for holding/orienting fasteners (e.g., bone screws).
- elastomer core 917 incorporates concave ends which mate with convex portions of corresponding intermediate elements 921a and 921b.
- these intermediate elements 921a and 921b may comprise "domes" formed at least in part from a material selected from the group including (but not limited to): PTFE 5 UHMWPE, a polyethylene, polished metal, and a high-lubricity, low-wear material.
- a material selected from the group including (but not limited to): PTFE 5 UHMWPE, a polyethylene, polished metal, and a high-lubricity, low-wear material Such a configuration may promote advantageous "shear" translation.
- the intermediate elements 921a and 921b may be attached to respective anchor plates via any of a number of means, including dimensional interference (press-fit), adhesive, and/or threaded means.
- the intermediate elements 921a and 921b may be "free floating".
- one or more of the domes may be integrally formed with one or more of the anchor plates.
- FIG. 1OA a cross sectional view of the AID assembly of Figure 9 (disposed between two vertebrae) is shown.
- the vertebrae are identified in this Figure 1OA as first vertebra 1001 and second vertebra 1002 and two fasteners (e.g., bone screws) are identified as elements 1003 and 1004 (other elements of this Figure 1OA are identified by the same reference numerals as the corresponding elements of Figure 9).
- FIG. 1OB an elevational view of the AID assembly of Figure 9 (disposed between two vertebrae is shown).
- elements of this Figure 1OB are identified by the same reference numerals as the corresponding elements of Figures 9 and 10A).
- FIG. 1OC a cross sectional view of an AID assembly similar to the AID assembly of Figure 9 (disposed between two vertebrae) is shown.
- the vertebrae are identified in this Figure 1OC as first vertebra 1001 and second vertebra 1002 and two fasteners (e.g., bone screws) are identified as elements 1003 and 1004 (other elements of this Figure 1 OC are identified by the same reference numerals as the corresponding elements of Figure 9).
- this embodiment differs mainly "from the embodiment of Figs. 9 3 1OA and 1OB in that this embodiment includes angled bone screws with hex drive interfaces.
- FIG. 1OD an elevational view of the AID assembly of Figure 1OC (disposed between two vertebrae) is shown.
- elements of this Figure 1OD are identified by the same reference numerals as the corresponding elements of Figure 10C).
- FIG. 10E 5 a cross-sectional view of the AID assembly of Figures 1OC and 1OD is shown.
- elements of this Figure 1OE are identified by the same reference numerals as the corresponding elements of Figures 1OC and 10D.
- this view shows the torque lock washers 1003a and 1003b (used for fixing the bone screws 1003 and 1004 in place).
- FIG 11 a perspective view of the intermediate elements 921a and 921b (e.g., PTFE "domes") and elastomer core 917 of Figure 9 are shown.
- intermediate elements 921a and 921b e.g., PTFE "domes”
- elastomer core 917 of Figure 9 are shown.
- Figure 12A a schematic view of the interface between the intermediate elements 921a and 921b (e.g., PTFE "domes") and elastomer core 917 of Figure 9 is shown (as Figure 12A) and a schematic view of another embodiment of the interface between two intermediate elements 921a' and 921b' and elastomer core 917' is shown (as Figure 12B).
- the configuration of Figure 12A may result in the core following the motion of the spine as well as the promotion of shear translation, while the configuration of Figure 12B may tend to resist shear translation.
- FIG 14 a perspective view of the AID assembly of Figure 9 inserted between two vertebrae is shown.
- FIG. 16A a cross sectional view of an AID assembly similar to the AID assembly of Figure 9 is shown. Similar elements of this Figure 16A are identified by the same reference numerals as the corresponding elements of Figure 9. Of note, this embodiment differs mainly from the embodiment of Fig. 9 in that this embodiment includes essentially flat "domes" 1600a and 1600b above and below the elastomer core.
- FIG. 16B an elevational view of the AID assembly of Figure 16A is shown.
- elements of this Figure 16B are identified by the same reference numerals as the corresponding elements of Figure 16 A.
- ePTFE column 1700 includes a number of holes 1701 A- 1701D therethrough in which respective column filler elements (e.g., formed from an elastomer) are disposed (Figure 17A is a top view and Figure 17B is a side view).
- respective column filler elements e.g., formed from an elastomer
- Figure 17A is a top view
- Figure 17B is a side view
- four holes are shown as an example only (which example is intended to be illustrative and not restrictive), and any desired number of holes may be used.
- some or all of the holes may include the filler (e.g., some of the holes may be fully or partially empty).
- ePTFE column 1800 includes a number of holes 1801 A- 1800E therethrough in which respective column filler elements (e.g., formed from an elastomer) are disposed
- Figure 18A is a top view
- Figure 18B is a side view
- Figure 18C is a perspective view
- five holes are shown as an example only (which example is intended to be illustrative and not restrictive), and any desired number of holes may be used.
- some or all of the holes may include the filler (e.g., some of the holes may be fully or partially empty).
- ePTFE column 1900 includes a number of holes 190 IA- 190 ID therethrough in which respective column filler elements (e.g., formed from an elastomer) are disposed (Figure 19A is a top view and Figure 19B is a side view).
- respective column filler elements e.g., formed from an elastomer
- Figure 19A is a top view
- Figure 19B is a side view
- four holes are shown as an example only (which example is intended to be illustrative and not restrictive), and any desired number of holes may be used.
- some or all of the holes may include the filler (e.g., some of the holes may be fully or partially empty).
- FIG. 19A and 19B differs from the embodiments of Figures 17A, 17B, 18 A, 18B and 18C in that in these Figures 19A and 19B the holes are not directly up and down between the top and bottom of the ePTFE column 1900.
- this single composite structure embodiment (which includes multiple holes for containing elastomer therein) may help prevent tissue and/or bone growth between discrete columns.
- this embodiment (which includes multiple holes for containing elastomer therein) may have one or more holes (e.g., vertically-oriented spaces, or lumens, running through the structure) of different sizes and shapes, each of which may be empty or filled (fully or partially) with an elastomeric material for purposes of adjustment of the behavior of the structure so as to mimic the behavior of the in vivo intervertebral disc in modes of bending, compression and torsion, and combinations thereof. It is believed that the placement of these lumens within the structure further allows for precise control of the structure in modes of bending, compression and torsion, and combinations thereof. As an additional means of control, the lumens may be filled (fully or partially) with an elastomeric material of one or more different elastic modulus.
- holes e.g., vertically-oriented spaces, or lumens, running through the structure
- an elastomeric material for purposes of adjustment of the behavior of the structure so as to mimic the behavior of the in vivo intervertebral disc in modes
- Figure 2OA shows a perspective view of AID assembly 2000 (this AID assembly 2000 utilizes two bone screws 2003 and 2004 for immediate fixation to the vertebrae);
- Figure 20B shows an exploded perspective view of AID assembly 2000 along with vertebrae 2005 and 2006 (between which AID assembly 2000 would be placed);
- Figure 2OC shows an exploded perspective view of AID assembly 2000 along with vertebrae 2005 and 2006 (this view is similar to Figure 2OB, but from a different angle);
- Figure 20D shows a closer perspective view of a portion of AID assembly 2000 of Figure 2OA (this view shows one anchor plate 2007 and associated bone screw 2003 and torque washer 2003a);
- Figure 2OE shows a perspective view of AID assembly 2010 (which AID assembly 2010 utilizes only one bone screw).
- Figure 21 A shows a perspective view of anterior cervical AID assembly 2100 (this AID assembly 2100 utilizes four bone screws (not shown) for immediate fixation to the vertebrae);
- Figure 2 IB shows a perspective view of anterior lumbar AID assembly 2110 (this AID assembly 2110 utilizes dovetail interfaces for immediate fixation to the vertebrae);
- Figure 21 C shows a perspective view of anterior lumbar AID assembly 2120 (this AID assembly 2120 utilizes angled gripping elements for immediate fixation to the vertebrae).
- Figure 22A shows a side view of AID assembly 2200 (this AID assembly 2200 utilizes an essentially linear line of three composite structures 2201 A-2201C mounted to anchor plates 2003A and 2203B;
- Figure 22B shows another view of AID assembly 2200 of Figure 22 A (the dovetail interfaces 2205A and 2205B for immediate fixation to the vertebrae are shown more clearly in this view);
- Figure 22C shows a perspective view of AID assembly 2200 of Figures 22A and 22B;
- Figure 22D is a cross-sectional view of AID assembly 2200 as shown in Figure 22B (as seen in this Figure 22D, a connection between anchor plate 2003A and a composite structure is shown using screw in ferrule 2207A and a connection between anchor plate 2003B and the composite structure is shown using screw in ferrule 2207B;
- Figure 22E shows a cross-sectional view of a composite structure (showing column (e.g.,
- Figure 23 A shows a perspective view of posterior lumbar AID assembly 2200' and 2200"
- Figure 23B shows a perspective view of posterior lumbar AID assembly 2200' and 2200" implanted between vertebra 2301 and 2302
- 2303 represents cancellous bone
- 2304 represents cortical shell
- 2305 represents vertebral endplate
- Figure 24 shows a perspective view of posterior lumbar AID assemblies 2400 and 2401 (angled protrusions aid in immediate fixation to the vertebrae).
- Figures 25A-25C and 26A-26C various views AID assembly 2500 implanted between vertebrae 2501 and 2502 are shown. More particularly, Figures 25 A and 26A show, respectively, side and perspective views of the AID assembly as initially implanted between the vertebrae; Figures 25B and 26B show, respectively, side and perspective views of the AID assembly as implanted between the vertebrae at a later time and as being partially overgrown by bone growth; and Figures 25C and 26C show, respectively, side and perspective views of the AID assembly as implanted between the vertebrae at a still later time and as being more overgrown by bone growth.
- Figure 27 shows a perspective view of AID assembly 2700 implanted between vertebrae 2701 and 2702.
- Figure 28 A shows a cephalad shape match between a vertebra interface portion of AID assembly 2800 and vertebra 2801; and Figure 28B shows a caudad shape match between a vertebra interface portion of AID assembly 2802 and vertebra 2803.
- Figure 29A shows AID assembly
- Figures 30A-30C views of still further embodiments of the present invention are shown. More particularly, Figure 3OA shows AID assembly
- Figure 30B shows AID assembly
- Figure 31 A shows AID assembly 3100 (surface treatment 3001 at an anchor plate/vertebra interface is seen in this Figure);
- Figure 3 IB shows AID assembly 3100 (surface treatment 3002 at an anchor plate/vertebra interface is seen in this Figure);
- Figure 31C shows one anchor plate of an AID assembly (surface treatment 3003 at an anchor plate/vertebra interface is seen in this Figure).
- Figure 32A shows example radii associated with a bone-contacting surface of Caudad Anchor Plate 3201 and Figure 32B shows example radii associated with a bone-contacting surface of Cephalad Anchor Plate 3203.
- FIG. 33 A shows AID assembly 3301 having a "narrow” width.
- Fig. 33B shows AID assembly 333 having a "regular” width and
- Fig. 3CA shows AID assembly 3305 having a "wide” 5 wide.
- a surgeon may scrape/score the bony surface in order to promote bone growth with the intention of securing ultimate fixation between vertebra and implant. If the scraped/scored surface is larger than the implanted device, there is a greater likelihood of bone growing up around the perimeter of the device, eventually causing bone bridging, fusing the spinal segment. A device with a surface that better matches the prepared endplate in terms of area coverage may help discourage this behavior.
- the column (which may be formed of ePTFE or any other desired material) may be an essentially solid chord or piece of material.
- the column (which may be formed of ePTFE and/or any other desired material(s)) may be an essentially solid combination of materials.
- the ePTFE may be provided with non-expanded regions, such as at the anchoring regions, for example.
- a column e.g., formed of ePTFE
- a column could be extruded to have greater wall thickness on one side or end as opposed to another side or end.
- the walls of the anterior side may be extruded thicker than the walls of the posterior side.
- the AID assembly may be customized to provide any desired articulation, kinematic behavior, dynamic behavior and/or static properties for any given application (e.g., implantation site) and/or patient (e.g., gender, age, height, weight, activity level).
- any given application e.g., implantation site
- patient e.g., gender, age, height, weight, activity level.
- the articulation, kinematic behavior, dynamic behavior and/or static properties exhibited by the column(s) may be modified by varying the density of the nodes of the ePTFE.
- the articulation, kinematic behavior, dynamic behavior and/or static properties exhibited by the column filler e.g., elastomer
- the column filler may be modified by varying the density and/or composition of the elastomer.
- the articulation, kinematic behavior, dynamic behavior and/or static properties exhibited by the AID assembly may be modified by varying (for individual components (e.g., ePTFE column, column filler, intermediate elements, anchor plates)): a) column height; b) column width (e.g., diameter); c) column cross-section (shape and/or area); d) column wall thickness; e) column stiffness modulus; f) filler height; g) filler width (e.g., diameter); h) filler cross-section (shape and/or area); i) filler stiffness modulus; j) anchor plate material; k) anchor plate shape; 1) anchor plate stiffness modulus; m) intermediate element material n) shape (e.g., curvature) of an interface between the filler and an anchor plate or intermediate element
- the articulation, kinematic behavior, dynamic behavior and/or static properties exhibited one or more composite structures in a multiple composite structure AID assembly may be modified by varying one or more parameters discussed at paragraph 3, above, to render one or more of the composite structures stiffer than one or more of the other composite structures in order to add stiffness locally and to aid in mimicry of in vivo non-homogeneous stiffness topography (e.g., the in vivo topography relating to the area of relatively higher stiffness in the posterior region of the vertebral body versus the relatively lower stiffness in the anterior region of the vertebral body).
- in vivo non-homogeneous stiffness topography e.g., the in vivo topography relating to the area of relatively higher stiffness in the posterior region of the vertebral body versus the relatively lower stiffness in the anterior region of the vertebral body.
- one or more of the composite structures may be positioned appropriately between the anchor plates as follows: a) one or more composite structures ma ⁇ f be placed an Increased distance from the center of the implant (e.g., to aid in increasing torsional stiffness of the implant); b) lateral positioning of one or more composite structures may be used (e.g., to aid in controlling lateral bending stiffness of the implant); c) fore/aft positioning of one or more composite structures may be used (e.g., to aid in controlling flexion/extension stiffness of the implant).
- the articulation, kinematic behavior, dynamic behavior and/or static properties exhibited may be controlled in a similar manner as discussed at paragraphs 4-6, above, with regard to the multiple composite structure AID (e.g., the spacing between the holes may be varied, the size/cross-sectional area/cross-sectional shape of the holes may be varied, the position of the various holes may be varied, the number of holes may be varied etc.).
- an artificial intervertebral disc comprising: a first anchor member; a second anchor member; and a composite structure disposed between the first anchor member and the second anchor member, which composite structure is comprised of a column formed of ePTFE and a column filler formed of an elastomer.
- the composite structure may be configured such that the composite structure has associated therewith, in at least one axis, a load versus deflection behavior substantially similar to that of a substantially healthy human intervertebral disc.
- the load versus deflection behavior may be selected from the group including (but not limited to): (a) dynamic behavior, which dynamic behavior is a function of a time rate application of load; (b) kinematic behavior; and (c) static behavior.
- the load versus deflection behavior may include a non ⁇ linear relationship between an amount of force required to compress the composite structure and a deflection of the composite structure.
- a stiffness of the composite structure may increase as the composite structure is compressed.
- column may have a hole therethrough.
- At least one of the column and the hole in the column may have a substantially circular cross-section.
- each of the column and the hole in the column may have a substantially circular cross-section.
- the column filler may be disposed within the hole in the column.
- the elastomer may be selected from the group including (but not limited to): (a) a silicone; (b) a urethane; and (c) a thermoplastic elastomer
- the composite structure may be attached to at least one of the first member and the second member.
- the composite structure may be attached by a mechanism selected from the group including (but not limited to): (a) compressing a portion of the column radially between a compression ferrule fitted in the hole in the column and a first mating surface of one of the first member and the second member, which first mating surface is formed by a hole through one of the first member and the second member; and (b) flaring an end of the column and compressing the flared portion of the column between a capturing component and a second mating surface of one of the first member and the second member.
- the column may be inserted through the hole in one of the first member and the second member before the end of the column is flared.
- the capturing component may be attached to one of the first member and the second member by a mechanism selected from the group including (but not limited to): (a) a mechanism for threading the capturing component to one of the first member and the second member; (b) a mechanism for adhesively bonding the capturing component to one of the first member and the second member (c) a mechanism for press-fitting the capturing component to one of the first member and the second member; and (d) a mechanism for affixing the capturing component to one of the first member and the second member via at least one threaded fastener.
- a mechanism for threading the capturing component to one of the first member and the second member including (but not limited to): (a) a mechanism for threading the capturing component to one of the first member and the second member; (b) a mechanism for adhesively bonding the capturing component to one of the first member and the second member (c) a mechanism for press-fitting the capturing component to one of the first member and the second member; and (d)
- the column may have a first end and a second end and at least one end of the column may be attached to a flange by a mechanism selected from the R ⁇ OUP including (but not limited to): (a) fusion welding; (b) chemical bonding; and (c) ultrasonic welding.
- the column maybe treated with a material which aids in the attachment to the flange, which treatment may be selected from the group including (but not limited to): (a) impregnating the column with the material; and (b) coating the column with the material.
- the flange may be attached to at least one of the first member and the second member by a mechanism selected from the group including (but not limited to): (a) capture behind a press-fit capture ring; (b) threading the flange onto at least one of the first member and the second member; and (c) attaching the flange to at least one of the first member and the second member via at least one threaded fastener.
- the column may be impregnated with a material that aids in preventing at least one of (but not limited to): (a) biological ingrowth into the column; and (b) biological attachment to the column.
- the column may be coated with a material that aids in preventing at least one of (but not lirhited to): (a) biological ingrowth into the column; and (b) biological attachment to the column.
- the artificial intervertebral disc may be configured to be implanted by at least one method selected from the group including (but not limited to): (a) posterior implantation; and (b) anterior implantation.
- an artificial intervertebral disc comprising: a first anchor member; a second anchor member; and at least two composite structures disposed between the first anchor member and the second anchor member, wherein a first one of the composite structures is comprised of a first column formed of ePTFE and a first column filler formed of an elastomer and a second one of the composite structures is comprised of a second column formed of ePTFE and a second column filler formed of an elastomer.
- first composite structure and the second composite structure may be configured such that the first composite structure and the second composite structure have associated in combination therewith, in at least one axis, a load versus deflection behavior substantially similar to that of a substantially healthy human intervertebral disc.
- the load versus deflection behavior may be selected from the ⁇ rou ⁇ including (but not limited to): (a) dynamic behavior, which dynamic behavior is a function of a time rate application of load; (b) kinematic behavior; and (C) static behavior.
- the load versus deflection behavior may include a non ⁇ linear relationship between an amount of force required to compress the first composite structure and the second composite structure and a deflection of the first composite structure and the second composite structure.
- a stiffness of each of the first composite structure and the second composite structure may increase as each of the first composite structure and the second composite structure is compressed.
- the artificial intervertebral disc may be configured to be implanted by at least one method selected from the group including (but not limited to): (a) posterior implantation; and (b) anterior implantation.
- an artificial intervertebral disc comprising: a first anchor member; a second anchor member; and a substantially solid chord of ePTFE disposed between the first anchor member and the second anchor member.
- an artificial intervertebral disc comprising: a first assembly including: (a) a first anchor member; (b) a second anchor member; and (c) a composite structure disposed between the first anchor member of the first assembly and the second anchor member of the first assembly, which composite structure of the first assembly is comprised of a column formed of ePTFE and a column filler formed of an elastomer; and a second assembly including: (a) a first anchor member; (b) a second anchor member; and (c) a composite structure disposed between the first anchor member of the second assembly and the second anchor member of the second assembly, which composite structure of the second assembly is comprised of a column formed of ePTFE and a column filler formed of an elastomer.
- the column e.g., formed of ePTFE
- the column filler may contain a compression element (e.g., a spring (e.g., constructed of a biocompatible material, such as titanium)).
- a compression element e.g., a spring (e.g., constructed of a biocompatible material, such as titanium)
- the materials used in constructing the AID assembly may be strong, durable and biocompatible.
- the anchor plates, ferrules, compression flanges, and/or springs mav be constructed of titanium 6AL4V ELI (extra low interstitial), a titanium alloy containing 6% aluminum and 4% vanadium.
- ePTFE which may be used to construct the columns, is a biocompatible material. Any additional elastomeric or non- elastomeric materials utilized in the assembly may be biocompatible.
- One of ordinary skill in the art would readily appreciate the other materials that could be used to construct implants according to the present invention.
- the column(s) may be coated (e.g., to help prohibit the growth of tissue and/or bone on the column(s), within the interstices of the nodes and/or between the fibrils in the column(s)).
- the coating may be silicone, urethane, any desired biocompatible elastomer layer and/or any combination thereof.
- the column(s) e.g., formed of ePTFE
- the filler e.g., the elastomer
- the device may resist shear translation and flexion of the spine may produce shear at one or more adjacent joints (e.g., a superior adjacent joint).
- flexion/extension may produce shear translation and rotation of a superior vertebral body.
- each of the first anchor plate and the second anchor plate includes a respective inner vertebra contacting surface for contacting an inner face of a vertebra (the vertebral endplate) and a respective outer vertebrae contacting surface for contacting an outer face of the vertebra (the substantially vertical outer surface on the anterior, posterior, or lateral sides of the vertebra).
- the flange may be attached to the anchor by a welded capture ring.
- the fastener hole(s) may include feature(s) or mechanism(s) therein for locking the fastener(s) in place, for the purpose of: (a) preventing the fastener from backing out; and/or (b) preventing the angular relation between the axis of the fastener and the axis of the through-hole from changing.
- one or more of the anchor member surfaces may be shaped to substantially match adjacent vertebral endplate surfaces to allow for minimal "carpentry" (or bone removal/shaping) during surgery to achieve good contact area (e.g. in cervical spine, the cephalad (towards the head) surface of the implant may be convex in the A-P (anterior-posterior) direction to match the A-P concavity in the vertebral endplate on the caudad (towards the feet) end of the vertebral body cephalad to the disc space and the caudad surface of the implant may be convex laterally to match the lateral concavity in the vertebral endplate on the cephalad end of the vertebral body caudal to the disc space).
- the cephalad (towards the head) surface of the implant may be convex in the A-P (anterior-posterior) direction to match the A-P concavity in the vertebral endplate on the caudad (towards
- one or more pieces of the AID may be sterilized separately, or a final AID unit may be sterilized as a unit.
- a final AID unit may be placed in a pouch and then sterilized (through the pouch).
- the implants of the present invention may provide one or more of the following attributes when inserted in the body (e.g., between vertebrae): o Essentially the same articulation as a healthy intervertebral disc (e.g., intervertebral lumbar disc, intervertebral cervical disc, intervertebral thoracic disc) may be realized;
- intervertebral disc e.g., intervertebral lumbar disc, intervertebral cervical disc, intervertebral thoracic disc
- intervertebral lumbar disc e.g., intervertebral lumbar disc, intervertebral cervical disc, intervertebral thoracic disc
- intervertebral disc e.g., intervertebral lumbar disc, intervertebral cervical disc, intervertebral thoracic disc
- intervertebral lumbar disc e.g., intervertebral lumbar disc, intervertebral cervical disc, intervertebral thoracic disc
- intervertebral disc e.g., intervertebral lumbar disc, intervertebral cervical disc, intervertebral thoracic disc
- implant and a healthy intervertebral disc may be substantially identical;
- the implant may be biocompatible
- the device may be implanted by posterior and/or anterior approaches;
- the device may install in a relatively short period of time (e.g., around 90 minutes);
- the device may exhibit positive results in fatigue tests (e.g., the device may be usable after 10x10 6 cycles); o The device may survive static loading, shear loading and testing to induce expulsion; o The device may fixate relatively rapidly to vertebral bodies; o The device may minimize contact stress with vertebral bodies at the device interface; and o The device may be auto-clavable.
- the AID assembly may include one or more of the following features: o
- the device may have lordosis (lordotic angle) built in (in one example the lordotic angle may place the composite structure substantially coincident with the axis of the functional spinal unit ("FSU")
- the anchor plate(s) may have surface treatment(s) to encourage osseointegration (bony ingrowth) to establish ultimate fixation to vertebral endplates.
- Such surface treatments may include (but not be limited to): electrochemical etch; plasma-sprayed Ti; sintered metallic beads or shards; bioactive/ osseoinductive/osseoconductive ceramic coating (e.g., hydroxyapatite (HA))
- the device may employ no screws, a single screw or multiple screws for fixation
- the device may include features to establish immediate fixation to vertebral endplates. Such features may include (but not be limited to): screw(s); keel(s); serration(s) (e.g., backward-facing serrations or angled bosses to 'bite' into place); sharp protrusion(s); finger(s)/protrusion(s) that can be deployed once device is in place
- the device may dampen strain energy via compliant composite structure(s)
- the columns may be reinforced.
- Such reinforcement may include (but not be limited to): exterior reinforcement; interior reinforcement; circumferential rib(s)/band(s); spiral ribbing/banding; rib(s)/band(s) of PTFE, nitinol, metal; rib(s ⁇ and(s) disconnected from column; rib(s)/band(s) connected to column; fusion weld; as part of extrusion process o
- a connection between a column and an anchor plate may include a frictional component, for example, due to compressive force capturing column/flange to plate (friction may be enhanced by roughened surface geometry (e.g., on mating anchor plate surface)) o
- a capturing component may be welded to an anchor plate o Holes in an anchor plate may enhance ability of sterilization (e.g., with EtU gas) o
- the column e.g., ePTFE column
- the column e.g., ePTFE column
- extreme fibers of ePTFE column may still be within elongation ratio even when device is at extreme limits of angular displacement (e.g., fully flexed, extended, laterally bent, or axially twisted) o
- the column (e.g., formed of ePTFE) surrounding the column filler may constrain the radial bulge of the column filler during compression, enhancing the molecular stacking of the material, causing the load-deflection response of the composite structure to be non-linear, like a healthy disc
- the bi-concave core may ride the convex dome surfaces such that the core follows the motion of the 'leading' anchor plate, promoting motion that mimics the shear displacement in an intact disc during bending
- the AID assembly may have multiple height options to appropriately match the height of disc being replaced and allowing for appropriate distraction to the segment during and after surgery to decompress anatomy, e.g. foraminal nerves (addressing the pathology)
- the AID assembly may have multiple sizes (e.g., in the anterior-posterior (A- P) dimension), allowing for proper placement of the composite structure coincident with the axis of the FSU
- the column of the composite structure e.g., an ePTFE column
- the anchor plates is affixed to the anchor plates to form a structural unit (this is, the column forms a structural "bridging link" between the anchor plates).
- the AID assembly is not pre-stressed. Since the AID assembly of this embodiment is not «pre-stressed, the column filler (e.g., elastomer) will not ejdiibit any significant amount of "creep 59 . In addition, the AID assembly of this embodiment will, at times, be under essentially no stress (e.g., when the patient using the AID assembly is lying down). Of note, this is similar behavior to a natural disc. Of further note, when the column is formed of ePTFE, the AID assembly of this embodiment may be capable of operating without being pre-stressed because of the properties of ePTFE.
- the ePTFE column may be sintered in tension.
- an AID assembly may be constructed by taking ePTFE, fusion welding PTFE to the ePTFE and sintering at the same time (while the ePTFE is held in an elongated position).
- the ePTFE may be supplied in an unsintered state and subsequently sintered during the construction of the AID assembly.
- the ePTFE may be supplied in a sintered (or partially sintered) state and subsequently sintered again during the construction of the AID assembly.
- a column when a column is utilized without a column filler (e.g., in the form of an essentially homogeneous structure), such a column may be integrated into the AID assembly (e.g., in terms of attachment to the anchor plates, patient customization) in essentially the same manner as a composite structure discussed herein.
- one or more components may be constructed of Ti, cobalt chromium, surgical steel and/or any combination thereof.
- customization may be carried out using multiple, interchangeable components (e.g., interchangeable composite structures).
- the customization may be carried out using a family of standard parts.
- customization of the AID assembly may be done at the place of manufacture (e.g., by a technician at the factory) and/or at the place of implantation (e.g., by a surgeon at the hospital).
- the vertebra contacting side of the anchor members may include gripping, tissue ingrowth promoting and/or bone ingrowth promoting elements, such as, for example (which examples are intended to be illustrative and not restrictive), grooves, teeth, protrusions, depressions or anv combination thereof.
- the mounting tabs associated with the anchor members may interface with the vertebrae along a planar interface, a curved interface, or a combination thereof.
- the mounting tabs may include gripping, tissue ingrowth promoting and/or bone ingrowth promoting elements such as described above.
- the column filler (e.g., elastomer) within the column may be of sufficient hardness as to form a distinct "core" within the column (such that the core fills essentially the entire space within the column or the core fills less than the entire space within the column (e.g., having one or more voids above the core, below the core and/or around the core between the core and the column)).
- the column filler (e.g., elastomer) within the column may be of insufficient hardness as to form a distinct "core" within the column but may instead fill the column in a more or less "fluid” manner (such that the column filler fills essentially the entire space within the column or the column filler fills less than the entire space within the column (e.g., having one or more voids above the column filler, below the column filler and/or around the column filler between the core and the column).
- the filler (e.g., elastomer) may be extruded/injected onto the column(s).
- the filler e.g., elastomer
- the filler may protrude out from the top, bottom and/or side(s) of the column.
- the protruding filler e.g., elastomer
- the protruding elastomer may be used to aid in attachment of the composite structure to the anchor plate (e.g., the protruding elastomer may be attached directly or indirectly (via an intermediate element) to an anchor plate using any desired attachment mechanism).
- the attachment of the column(s) and/or composite structure(s) to the anchor plates may be carried out using a press fit, a rotary swage, welding (e.g., spot or continuous), a number of discrete interference dings, a forced interference fit, a threaded fit, a punch mechanism at a seam between parts and/or any other desired method (as well, of course, as any combination thereof).
- the device may be shaped as desired, such as having a circular shape, an oval shape or a kidney shape, for example (this could be effected by providing a desired shape to any of the components (e.g., the anchor plates and/or the column(s) and/or the composite structure(s))).
- the composite structure(s) may essentially fill the space between the anchor plates or there may be empty space between the composite structure(s).
- the column filler, the material used to coat the column(s) and/or the material impregnated into the column(s) may be any desired compressible, elastic compressible, extrudable and/or flowable material (or combination thereof).
- the load/deflection curves associated with the present invention may result from underlying data having applied thereto any desired type of curve fitting (e.g., polynomial curve fitting to the second or third power).
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PCT/US2004/022778 WO2006019370A1 (fr) | 2004-07-15 | 2004-07-15 | Disque intervertébral artificiel |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PCT/US2004/022778 WO2006019370A1 (fr) | 2004-07-15 | 2004-07-15 | Disque intervertébral artificiel |
Publications (1)
Publication Number | Publication Date |
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WO2006019370A1 true WO2006019370A1 (fr) | 2006-02-23 |
Family
ID=35907680
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2004/022778 WO2006019370A1 (fr) | 2004-07-15 | 2004-07-15 | Disque intervertébral artificiel |
Country Status (1)
Country | Link |
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WO (1) | WO2006019370A1 (fr) |
Cited By (8)
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---|---|---|---|---|
WO2007146482A3 (fr) * | 2006-06-09 | 2008-07-31 | Zimmer Spine Inc | plaque occipitale réglable |
US7621942B2 (en) | 2005-03-21 | 2009-11-24 | Zimmer Spine, Inc. | Variable geometry occipital fixation plate |
US7901433B2 (en) | 2006-10-04 | 2011-03-08 | Zimmer Spine, Inc. | Occipito-cervical stabilization system and method |
EP1819305A4 (fr) * | 2004-11-26 | 2011-09-21 | Spine Solutions Inc | Implant intervertebral |
US8147527B2 (en) | 2006-11-28 | 2012-04-03 | Zimmer Spine, Inc. | Adjustable occipital plate |
US8246662B2 (en) | 2006-12-27 | 2012-08-21 | Zimmer Spine, Inc. | Modular occipital plate |
US8636737B2 (en) | 2006-12-27 | 2014-01-28 | Zimmer Spine, Inc. | Modular occipital plate |
US9943417B2 (en) | 2012-06-29 | 2018-04-17 | DePuy Synthes Products, Inc. | Lateral insertion spinal implant |
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US5171281A (en) * | 1988-08-18 | 1992-12-15 | University Of Medicine & Dentistry Of New Jersey | Functional and biocompatible intervertebral disc spacer containing elastomeric material of varying hardness |
US5507823A (en) * | 1993-12-28 | 1996-04-16 | Walston; D. Kenneth | Joint prosthesis having PTFE cushion |
US6001130A (en) * | 1994-11-14 | 1999-12-14 | Bryan; Vincent | Human spinal disc prosthesis with hinges |
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Cited By (14)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1819305A4 (fr) * | 2004-11-26 | 2011-09-21 | Spine Solutions Inc | Implant intervertebral |
US8337496B2 (en) | 2005-03-21 | 2012-12-25 | Zimmer Spine, Inc. | Variable geometry occipital fixation plate |
US7621942B2 (en) | 2005-03-21 | 2009-11-24 | Zimmer Spine, Inc. | Variable geometry occipital fixation plate |
US8007499B2 (en) | 2005-03-21 | 2011-08-30 | Zimmer Spine, Inc. | Variable geometry occipital fixation plate |
WO2007146482A3 (fr) * | 2006-06-09 | 2008-07-31 | Zimmer Spine Inc | plaque occipitale réglable |
US7901433B2 (en) | 2006-10-04 | 2011-03-08 | Zimmer Spine, Inc. | Occipito-cervical stabilization system and method |
US8740953B2 (en) | 2006-11-28 | 2014-06-03 | Zimmer Spine, Inc. | Adjustable occipital plate |
US8147527B2 (en) | 2006-11-28 | 2012-04-03 | Zimmer Spine, Inc. | Adjustable occipital plate |
US8246662B2 (en) | 2006-12-27 | 2012-08-21 | Zimmer Spine, Inc. | Modular occipital plate |
US8636737B2 (en) | 2006-12-27 | 2014-01-28 | Zimmer Spine, Inc. | Modular occipital plate |
US9439687B2 (en) | 2006-12-27 | 2016-09-13 | Zimmer Spine, Inc. | Modular occipital plate |
US9943417B2 (en) | 2012-06-29 | 2018-04-17 | DePuy Synthes Products, Inc. | Lateral insertion spinal implant |
US11413159B2 (en) | 2012-06-29 | 2022-08-16 | DePuy Synthes Products, Inc. | Lateral insertion spinal implant |
US11717421B2 (en) | 2012-06-29 | 2023-08-08 | DePuy Synthes Products, Inc. | Lateral insertion spinal implant |
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