US20210077269A1 - Composite interbody system - Google Patents
Composite interbody system Download PDFInfo
- Publication number
- US20210077269A1 US20210077269A1 US16/864,485 US202016864485A US2021077269A1 US 20210077269 A1 US20210077269 A1 US 20210077269A1 US 202016864485 A US202016864485 A US 202016864485A US 2021077269 A1 US2021077269 A1 US 2021077269A1
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- US
- United States
- Prior art keywords
- cis
- shaped
- segment
- upper plate
- materials
- 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
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
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- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
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- A61F2/447—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/38—Materials or treatment for tissue regeneration for reconstruction of the spine, vertebrae or intervertebral discs
Definitions
- Various embodiments described herein relate generally to treating mammalian bony segments, including systems and methods that employ an interbody implant to stabilize, maintain spacing between, or couple one or more mammalian bony segments.
- an interbody implant that enables visualization while enabling bony fusion, providing stabilization, or maintaining a desired spacing between bony segments, the present invention provides such an interbody implant.
- FIG. 1A is a simplified isometric view of a composite interbody system according to various embodiments.
- FIG. 1B is a simplified isometric, exploded view of a composite interbody system according to various embodiments.
- FIG. 1C is a simplified front view of a composite interbody system according to various embodiments.
- FIG. 1D is a simplified rear view of a composite interbody system according to various embodiments.
- FIG. 1E is a simplified top view of a composite interbody system according to various embodiments.
- FIG. 1F is a simplified bottom view of a composite interbody system according to various embodiments.
- FIG. 1G is a simplified right side view of a composite interbody system according to various embodiments.
- FIG. 1H is a simplified left side view of a composite interbody system according to various embodiments.
- FIG. 1I is a simplified vertical cross sectional left side view of the composite interbody system shown in FIG. 1C taken along line AA according to various embodiments.
- FIG. 1J is a simplified isometric cross sectional view of the composite interbody system shown in FIG. 1D taken along line BB according to various embodiments.
- FIG. 2A is a simplified isometric view of a main module of a composite interbody system according to various embodiments.
- FIG. 2B is a simplified vertical cross sectional left side view of the main module of a composite interbody system shown in FIG. 2C taken along line CC according to various embodiments.
- FIG. 2C is a simplified front view of a main module of a composite interbody system according to various embodiments.
- FIG. 2D is a simplified rear view of a main module of a composite interbody system according to various embodiments.
- FIG. 2E is a simplified top view of a main module of a composite interbody system according to various embodiments.
- FIG. 2F is a simplified bottom view of a main module of a composite interbody system according to various embodiments.
- FIG. 2G is a simplified right side view of a main module of a composite interbody system according to various embodiments.
- FIG. 2H is a simplified left side view of a main module of a composite interbody system according to various embodiments.
- FIG. 3A is a simplified isometric view of an upper module of a composite interbody system according to various embodiments.
- FIG. 3B is a simplified front view of an upper module of a composite interbody system according to various embodiments.
- FIG. 3C is a simplified rear view of an upper module of a composite interbody system according to various embodiments.
- FIG. 3D is a simplified top view of an upper module of a composite interbody system according to various embodiments.
- FIG. 3E is a simplified bottom view of an upper module of a composite interbody system according to various embodiments.
- FIG. 3F is a simplified right side view of an upper module of a composite interbody system according to various embodiments.
- FIG. 3G is a simplified left side view of an upper module of a composite interbody system according to various embodiments.
- FIG. 4A is a simplified isometric front view of a lower module to upper module linking element of a composite interbody system according to various embodiments.
- FIG. 4B is a simplified isometric bottom view of a lower module to upper module linking element of a composite interbody system according to various embodiments.
- FIG. 4C is a simplified right-side view of a lower module to upper module linking element of a composite interbody system according to various embodiments.
- FIG. 5A is a posterior view of a body segment treatment architecture including a composite interbody system operatively between a center bony segment and an adjacent upper bony segment according to various embodiments.
- FIG. 5B is a left side view of a body segment treatment architecture including a composite interbody system operatively between a center bony segment and an adjacent upper bony segment according to various embodiments.
- an interbody implant 10 between two, adjacent bony regions or segments 72 A-C as shown in architecture 70 in FIGS. 5A-5B to enable the regions to become stabilized, joined, separated by a minimum distance, or fused together.
- the bony segments 72 A-C may be separated by one or more non-bony elements 74 A-B, for example the bony segments 72 A-C may be vertebra separated by spinal discs 74 A-B in a cervical, thoracic, or lumbar region of a mammal including a human.
- an interbody implant 10 may be inserted between adjacent bony segments 72 A-C in order to maintain a desired distance between the segments 72 A-C. After insertion, an interbody implant 10 may ideally fuse with the adjacent segments 72 A-C to form a bony fusion between the segments 72 A-C while maintaining the desired distance between the segments 72 A-C. In addition, a medical professional may wish to verify the implant's location between the segments 72 A-C via a radiation-based imaging system.
- the interbody implant 10 is a composite interbody implant 10 including upper and lower modules 40 A, 40 B that promote bony fusion and a main module 20 that is substantially radiographically translucent.
- FIG. 1A is a simplified isometric view of a composite interbody system 10 according to various embodiments.
- the composite interbody system 10 may include a main module 20 , an upper module 40 A, a lower module 40 B, a first linking module 60 A, and a second linking module 60 B.
- the composite interbody system 10 may be substantially cubic in shape with convexly curved right, left, and front sides 12 A, 12 B, 12 E, a concavely curved back side 12 F, and a large central fenestration 14 extending from a top side 12 C to a bottom side 12 D of the system 10 .
- FIG. 1B is a simplified isometric, exploded view of the composite interbody system 10 according to various embodiments.
- the upper module 40 A may be slidably coupled to front 22 E and side 22 A, 22 B portions of the top side 22 C of the main module 20 .
- the lower module 40 B may be similarly slidably coupled to front 22 E and side 22 A, 22 B portions of the bottom side 22 C of the main module 20 .
- the upper module 40 A may be fixably coupled to back 22 F portions of the top side 22 C of the main module 20 and the lower module 40 B may be fixably coupled to back 22 F portions of the bottom side 22 D of the main module 20 via a right linking module 60 A and a left linking module 60 B.
- the right linking module 60 A may fixably link the upper module 40 A to the lower module 40 B via the main module 20 right, back fenestration 28 A.
- the left linking module 60 B may fixably link the upper module 40 A to the lower module 40 B via the main module 20 left, back fenestration 28 B.
- the main module 20 is formed of a first material or complex of materials.
- the upper and lower modules 40 A, 40 B may be formed of a second, different material or complex of materials. In an embodiment, the upper and lower modules 40 A, 40 B may be formed of different materials or complex of materials.
- the right and left linking modules 60 A, 60 B may be formed of a third, different material or complex of materials. In an embodiment, the right and left linking modules 60 A, 60 B may be formed of a different materials or complex of materials.
- the upper and lower modules 40 A, 40 B and the right and left linking modules 60 A, 60 B may be formed of the same second material or complex of materials.
- the first material or complex of materials may be a biocompatible, substantially radio-lucent material or complex of materials. In an embodiment, the first material or complex of materials may be a biocompatible, radio-opaque material or complex of materials. In an embodiment, the second material or complex of materials may be a biocompatible, substantially radio-opaque material or complex of materials. In an embodiment, the third material or complex of materials may be a biocompatible, substantially radio-opaque material or complex of materials.
- the second material or complex of materials may be a biocompatible, osteoconductive material or complex of materials.
- the third material or complex of materials may also be a biocompatible, osteoconductive material or complex of materials.
- the first material or complex of materials may also be a biocompatible, less osteoconductive material or complex of materials than the first and second materials or complex of materials.
- the main module 20 may be formed of a polymer, ceramic, or combination of both, including Polyether ether ketone (PEEK) or other member of the polyaryletherketone family.
- the upper and lower modules 40 A, 40 B may be formed of a metal, alloy, or other osteoconductive material.
- the upper and lower modules 40 A, 40 B may be formed from Titanium.
- the right and left linking modules 60 A, 60 B may be formed of a metal, alloy, or other biocompatible material.
- the right and left linking modules 60 A, 60 B may be formed from Titanium.
- a composite interbody system 10 may be employed between cervical vertebrae in a human.
- a composite interbody system 10 may have a maximum length (from front side 12 E to back side 12 F) of about 6 to 18 mm and 12 mm in an embodiment where the maximum length may vary as function of its intended use or placement.
- a composite interbody system 10 may have a maximum width (from right side 12 A to left side 12 B) of about 6 to 20 mm and 14 mm in an embodiment where the maximum width may also vary as function of its intended use or placement.
- a composite interbody system 10 may have a maximum height (from top side 12 C to bottom side 12 D) of about 3 to 18 mm and 5 mm to 12 mm in an embodiment where the maximum height may also vary as function of its intended use or placement and the desired minimum distance between bony segments 72 A-C.
- a composite interbody system 10 central fenestration 14 opening maximum length (from front to back) may be about 3 to 15 mm and 7 mm in an embodiment where the maximum length may vary as function of its intended use or placement.
- a composite interbody system 10 may have a maximum width (from right side 12 A to left side 12 B) of about 3 to 15 mm and 8 mm in an embodiment where the maximum width may also vary as function of its intended use or placement.
- FIG. 1C is a simplified front view of a composite interbody system 10 according to various embodiments.
- the composite interbody system 10 front side 12 E may include several penetrations 24 A, 24 B, 24 C.
- the penetrations 24 A- 24 C may extend front side 12 E to the central vertical fenestration 14 and form front side fenestrations.
- the center fenestration 24 C may be threaded to mate with a tool threaded pin.
- one or more of the other penetrations or fenestrations 24 A, 24 B may also be threaded.
- the combination of a threaded center fenestration 24 C and the right and left fenestrations 24 A, 24 B may enable a medical professional to securely engage and rotate the composite interbody system 10 during implantation between two bony segments 72 A-C or removal of the composite interbody system 10 (such as during a revision procedure).
- the composite interbody system 10 is inserted between bony segments 72 A-C starting with its back side 12 F.
- the fenestrations 24 A-C may have a similar diameter of about 0.5 to 5 mm and 1.6 mm in an embodiment such a cervical spine application.
- the center fenestration 24 C may be located about center (from top 12 C to bottom 12 D and left 12 B to right 12 A).
- the other fenestrations 24 A, 24 B may located centrally from the top 12 C to bottom 12 D and have a center about 1 mm to 6 mm from the fenestration 24 C and about 3 mm in an embodiment.
- the composite interbody system 10 top side 12 C and bottom side 12 D may be convexly curved from the approximate center of the front side 12 E.
- the effective curvature of the top side 12 C and bottom side 12 D measured from its peak (left and right of peak) is about 15 mm to 50 mm and about 30 mm in an embodiment.
- the upper and lower module 40 A, 40 B may have a front extension 46 C that is sized to be placed between right and left shoulders 26 A, 26 B ( FIG. 2A ) of the main module 20 . It is noted that is an embodiment that the upper and lower modules 40 A, 40 B may be identical and the main module top side 22 C layout and bottom side 22 D layout may also be identical.
- FIG. 1D is a simplified rear view of a composite interbody system 10 according to various embodiments. As shown in FIGS. 1A, 1B, and 1D (and others), the composite interbody system 10 is sloped from its front side 12 E to its back side 12 F. In an embodiment, the composite interbody system 10 may be sloped about 2 to 12 degrees from its front side 12 E to back side 12 F as function of its intended application and about 6 degrees for a cervical spine application in an embodiment.
- FIG. 1E is a simplified top view of a composite interbody system 10 according to various embodiments. As shown in FIG.
- the composite interbody system 10 main module 20 may has partial shoulders 26 A, 26 B where the upper module 40 A is inset on the right side 12 A and left side 12 B and extends to the front 12 E and back area 12 F.
- the upper and lower modules 40 A, 40 B may be effectively plates in an embodiment and have fenestration that matches the composite interbody system 10 fenestration 14 and the main body fenestration 28 C.
- the composite interbody system 10 right 12 A and left 12 B wall maximum thickness may be about 1 to 5 mm and about 3 mm in an embodiment.
- the composite interbody system 10 front 12 E and back 12 F wall maximum thickness may be about 1 to 5 mm and about 2.5 mm in an embodiment.
- the upper and lower modules 40 A, 40 B may be comprised of an osteoconductive material and may be positioned in a cervical spine application to engage cancellous bone, thereby increasing the possibility of bony fusion with adjacent segments or vertebrae 72 A-C.
- the upper and lower modules 40 A, 40 B may include various sized divots 43 A, 43 B that may further induce bony in growths and thus bony fusion.
- the divots or holes 43 A, 43 B may have a diameter of about 0.2 to 2 mm and about 0.75 mm and 0.5 mm respectively.
- the divots or holes 43 A, 43 B may have a depth of about 0.2 to 2 mm and about 0.5 mm respectively in an embodiment.
- FIG. 1F is a simplified bottom view of a composite interbody system 10 according to various embodiments. As shown in FIG. 1F , the composite interbody system 10 bottom side 12 D may be symmetrical to the composite interbody system 10 top side 12 C.
- FIG. 1G is a simplified right side 12 A view of a composite interbody system according to various embodiments.
- FIG. 1H is a simplified left side view 12 B of a composite interbody system according to various embodiments. As shown in FIGS. 1G and 1H , the composite interbody system 10 right side 12 A may be symmetrical to the composite interbody system 10 left side 12 B.
- FIGS. 1G and 1H also shown how a portion the upper and lower modules 40 A dovetails into the main module 20 shoulders 26 A, 26 B.
- the main module 20 shoulders 26 A, 26 B undercuts 26 C enable the upper and lower modules 40 A and 40 B to slidably dovetail into the main body and secure the modules 40 A, 40 B right and left sides 42 A, 42 B to the main module 20 .
- the linking modules 60 A (right) and 60 B (left) extending through the main body via fenestrations 28 A, 28 B and coupled to the modules 40 A, 40 B back 42 F corners ensure the modules 40 A, 40 B do not slide relative to the main module 20 .
- FIG. 11 is a simplified vertical cross sectional left side view of the composite interbody system 10 shown in FIG. 1C taken along line AA according to various embodiments.
- the main module 20 center fenestration 24 C may have threads extending only its entire length.
- FIG. 1J is a simplified isometric cross sectional view of the composite interbody system 10 shown in FIG. 1D taken along line BB according to various embodiments.
- the linking modules 60 A, 60 B shafts 62 A, 62 B extend through the main module 20 fenestrations 28 A, 28 B.
- the linking modules 60 A, 60 B shafts 62 A, 62 B inner diameter and the main module 20 fenestrations 28 A, 28 B diameter are about 0.5 to 3 mm and about 1.5 mm in an embodiment.
- FIG. 2A is a simplified isometric view of a main module 20 of a composite interbody system 10 according to various embodiments.
- FIG. 2B is a simplified vertical cross sectional left side view of the main module 20 of a composite interbody system 10 shown in FIG. 2C taken along line CC according to various embodiments.
- the main module 20 includes right and left shoulders 26 A, 26 B including undercuts 26 C.
- the undercuts 26 C may be sized to enable upper and lower modules 40 A, 40 B flanges or dovetails 46 A, 46 B to slidably and securely engage.
- FIG. 2C is a simplified front view 22 E of a main module 20 of a composite interbody system 10 according to various embodiments.
- the main body includes a front gap 26 E formed by the right and left shoulders 26 A, 26 B where the gap 26 E is sized to accommodate the upper and lower modules 40 A, 40 B front extensions 46 C.
- FIG. 2D is a simplified rear view 22 F of a main module of a composite interbody system according to various embodiments.
- FIG. 2D shown its top 22 C may be symmetrical with its bottom 22 D.
- the main module 20 shoulders 26 A, 26 B may also form a an opening in the back 22 F, top surface 22 C to accommodate the upper and lower modules 40 A, 40 B back sides 42 F.
- FIG. 2E is a simplified top view 22 C of a main module 20 of a composite interbody system 10 according to various embodiments.
- FIG. 2F is a simplified bottom view 22 D of a main module 20 of a composite interbody system 10 according to various embodiments.
- the main module 20 may include a central fenestration 28 C that is similar or identical in size (length and width) as the upper and lower modules 40 A, 40 B central fenestrations 48 C and form the composite interbody system 10 central fenestration 14 .
- the composite interbody system 10 central fenestration 14 may be packed with osteoconductive material including autogenic bone to aid bony fusion between bony segments 72 A-C where the composite interbody system 10 is intended to be deployed.
- the main module 20 central fenestration 28 C may convexly curved back, left and right corners 29 A and concavely curved front, left and right corners 29 B.
- FIG. 2G is a simplified right-side view and FIG. 2H is a simplified left side view of a main module 20 of a composite interbody system 10 according to various embodiments.
- the composite interbody system 10 top 12 C and bottom 12 D and the main body 10 top 22 C and bottom 22 D may be sloped downwardly from its front side 22 E to its back side 22 F, about 6 degrees in an embodiment.
- the slope inclination from front 12 E to back 12 F may be selected or configured to match the bony segment surfaces including vertebra lordosis.
- FIG. 3A is a simplified isometric view
- FIG. 3B is a simplified front view
- FIG. 3C is a simplified rear view of an upper module 40 A of a composite interbody system 10 according to various embodiments.
- FIG. 3D is a simplified top view
- FIG. 3E is a simplified bottom view of an upper module 40 A of a composite interbody system 10 according to various embodiments.
- FIG. 3F is a simplified right-side view
- FIG. 3G is a simplified left side view of an upper module 40 A of a composite interbody system 10 according to various embodiments.
- the lower module 40 B may be symmetrical to the upper module 40 A and thus FIGS. 3A to 3G may also be views of the lower module 40 B in an embodiment. As shown in FIGS.
- the upper and lower modules 40 A, 40 B may include flanges or dovetails 46 A, 46 B on their respective right side 42 A and left side 42 B.
- the upper and lower modules 40 A, 40 B may include fenestrations 48 A, 48 B sized to accommodate the linking modules 60 A, 60 B shafts 62 A, 62 B while engaging their heads 64 A or compressed tips 66 A.
- FIG. 4A is a simplified isometric front view
- FIG. 4B is a simplified isometric bottom view
- FIG. 4C is a simplified right-side view of a lower module to upper module linking element 60 A of a composite interbody system 10 according to various embodiments.
- the linking element 60 A may be identical to the linking module 60 B.
- the linking module 60 A may include a head 64 A, elongated shaft 62 A, and compressible tip 66 A in an embodiment.
- the head 64 A diameter may be about 1 mm to 4 mm and about 2.25 mm when the shaft 62 B diameter is about 1.5 mm.
- the linking module 60 A overall length (from head 64 A to tip 66 A) may vary as a function of the composite interbody system 10 height. In an embodiment, the linking modules 60 A overall length may be about 0.7 mm less than the composite interbody system 10 maximum height.
- the linking module 60 A tip 66 A may be compressible via an opening 68 A in the shaft 62 A tip 66 A to enable secure engagement with the upper module 40 A right fenestration 48 A.
- the linking module 60 B tip 66 A may be compressible via an opening 68 A in the shaft 62 A tip 66 A to enable secure engagement with the lower module 40 A left fenestration 48 B.
- the opening 68 A may have a diameter of about 0.2 to 1.5 mm and about 0.8 mm when the shaft 62 A diameter is about 1.5 mm.
- the opening 68 A may have a length of about 0.5 to 3 mm and about 1.5 mm when the shaft 62 A diameter is about 1.5 mm.
- inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is in fact disclosed.
- inventive concept any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown.
- This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.
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Abstract
Embodiments of a composite interbody system 10 for treating mammalian bony segments including various materials to encourage bony fusion while enabling radiographic visualization where the composite interbody system 10 may be employed between two, adjacent mammalian bony segments to stabilize, maintain spacing between, or couple the bony segments. Other embodiments may be described and claimed.
Description
- Various embodiments described herein relate generally to treating mammalian bony segments, including systems and methods that employ an interbody implant to stabilize, maintain spacing between, or couple one or more mammalian bony segments.
- It may be desirable to treat one or more bony segments via an interbody implant that enables visualization while enabling bony fusion, providing stabilization, or maintaining a desired spacing between bony segments, the present invention provides such an interbody implant.
-
FIG. 1A is a simplified isometric view of a composite interbody system according to various embodiments. -
FIG. 1B is a simplified isometric, exploded view of a composite interbody system according to various embodiments. -
FIG. 1C is a simplified front view of a composite interbody system according to various embodiments. -
FIG. 1D is a simplified rear view of a composite interbody system according to various embodiments. -
FIG. 1E is a simplified top view of a composite interbody system according to various embodiments. -
FIG. 1F is a simplified bottom view of a composite interbody system according to various embodiments. -
FIG. 1G is a simplified right side view of a composite interbody system according to various embodiments. -
FIG. 1H is a simplified left side view of a composite interbody system according to various embodiments. -
FIG. 1I is a simplified vertical cross sectional left side view of the composite interbody system shown inFIG. 1C taken along line AA according to various embodiments. -
FIG. 1J is a simplified isometric cross sectional view of the composite interbody system shown inFIG. 1D taken along line BB according to various embodiments. -
FIG. 2A is a simplified isometric view of a main module of a composite interbody system according to various embodiments. -
FIG. 2B is a simplified vertical cross sectional left side view of the main module of a composite interbody system shown inFIG. 2C taken along line CC according to various embodiments. -
FIG. 2C is a simplified front view of a main module of a composite interbody system according to various embodiments. -
FIG. 2D is a simplified rear view of a main module of a composite interbody system according to various embodiments. -
FIG. 2E is a simplified top view of a main module of a composite interbody system according to various embodiments. -
FIG. 2F is a simplified bottom view of a main module of a composite interbody system according to various embodiments. -
FIG. 2G is a simplified right side view of a main module of a composite interbody system according to various embodiments. -
FIG. 2H is a simplified left side view of a main module of a composite interbody system according to various embodiments. -
FIG. 3A is a simplified isometric view of an upper module of a composite interbody system according to various embodiments. -
FIG. 3B is a simplified front view of an upper module of a composite interbody system according to various embodiments. -
FIG. 3C is a simplified rear view of an upper module of a composite interbody system according to various embodiments. -
FIG. 3D is a simplified top view of an upper module of a composite interbody system according to various embodiments. -
FIG. 3E is a simplified bottom view of an upper module of a composite interbody system according to various embodiments. -
FIG. 3F is a simplified right side view of an upper module of a composite interbody system according to various embodiments. -
FIG. 3G is a simplified left side view of an upper module of a composite interbody system according to various embodiments. -
FIG. 4A is a simplified isometric front view of a lower module to upper module linking element of a composite interbody system according to various embodiments. -
FIG. 4B is a simplified isometric bottom view of a lower module to upper module linking element of a composite interbody system according to various embodiments. -
FIG. 4C is a simplified right-side view of a lower module to upper module linking element of a composite interbody system according to various embodiments. -
FIG. 5A is a posterior view of a body segment treatment architecture including a composite interbody system operatively between a center bony segment and an adjacent upper bony segment according to various embodiments. -
FIG. 5B is a left side view of a body segment treatment architecture including a composite interbody system operatively between a center bony segment and an adjacent upper bony segment according to various embodiments. - It may be desirable to place an
interbody implant 10 between two, adjacent bony regions orsegments 72A-C as shown inarchitecture 70 inFIGS. 5A-5B to enable the regions to become stabilized, joined, separated by a minimum distance, or fused together. Thebony segments 72A-C may be separated by one or morenon-bony elements 74A-B, for example thebony segments 72A-C may be vertebra separated byspinal discs 74A-B in a cervical, thoracic, or lumbar region of a mammal including a human. - In an embodiment, an
interbody implant 10 may be inserted between adjacentbony segments 72A-C in order to maintain a desired distance between thesegments 72A-C. After insertion, aninterbody implant 10 may ideally fuse with theadjacent segments 72A-C to form a bony fusion between thesegments 72A-C while maintaining the desired distance between thesegments 72A-C. In addition, a medical professional may wish to verify the implant's location between thesegments 72A-C via a radiation-based imaging system. Theinterbody implant 10 according to an embodiment is acomposite interbody implant 10 including upper andlower modules main module 20 that is substantially radiographically translucent. -
FIG. 1A is a simplified isometric view of acomposite interbody system 10 according to various embodiments. As shown inFIG. 1A , thecomposite interbody system 10 may include amain module 20, anupper module 40A, alower module 40B, afirst linking module 60A, and asecond linking module 60B. As shown inFIG. 1A , thecomposite interbody system 10 may be substantially cubic in shape with convexly curved right, left, andfront sides back side 12F, and a largecentral fenestration 14 extending from atop side 12C to abottom side 12D of thesystem 10. -
FIG. 1B is a simplified isometric, exploded view of thecomposite interbody system 10 according to various embodiments. As shown inFIG. 1B , in an embodiment, theupper module 40A may be slidably coupled tofront 22E andside top side 22C of themain module 20. Thelower module 40B may be similarly slidably coupled tofront 22E andside bottom side 22C of themain module 20. Theupper module 40A may be fixably coupled to back 22F portions of thetop side 22C of themain module 20 and thelower module 40B may be fixably coupled to back 22F portions of thebottom side 22D of themain module 20 via aright linking module 60A and aleft linking module 60B. In an embodiment, theright linking module 60A may fixably link theupper module 40A to thelower module 40B via themain module 20 right, backfenestration 28A. Similarly, theleft linking module 60B may fixably link theupper module 40A to thelower module 40B via themain module 20 left,back fenestration 28B. - In an embodiment, the
main module 20 is formed of a first material or complex of materials. The upper andlower modules lower modules modules modules lower modules modules - In an embodiment, the first material or complex of materials may be a biocompatible, substantially radio-lucent material or complex of materials. In an embodiment, the first material or complex of materials may be a biocompatible, radio-opaque material or complex of materials. In an embodiment, the second material or complex of materials may be a biocompatible, substantially radio-opaque material or complex of materials. In an embodiment, the third material or complex of materials may be a biocompatible, substantially radio-opaque material or complex of materials.
- In an embodiment, the second material or complex of materials may be a biocompatible, osteoconductive material or complex of materials. In an embodiment, the third material or complex of materials may also be a biocompatible, osteoconductive material or complex of materials. In an embodiment, the first material or complex of materials may also be a biocompatible, less osteoconductive material or complex of materials than the first and second materials or complex of materials. In an embodiment, the
main module 20 may be formed of a polymer, ceramic, or combination of both, including Polyether ether ketone (PEEK) or other member of the polyaryletherketone family. The upper andlower modules lower modules modules modules - In an embodiment, a
composite interbody system 10 may be employed between cervical vertebrae in a human. For such an application or use, acomposite interbody system 10 may have a maximum length (fromfront side 12E to backside 12F) of about 6 to 18 mm and 12 mm in an embodiment where the maximum length may vary as function of its intended use or placement. Acomposite interbody system 10 may have a maximum width (fromright side 12A toleft side 12B) of about 6 to 20 mm and 14 mm in an embodiment where the maximum width may also vary as function of its intended use or placement. Acomposite interbody system 10 may have a maximum height (fromtop side 12C tobottom side 12D) of about 3 to 18 mm and 5 mm to 12 mm in an embodiment where the maximum height may also vary as function of its intended use or placement and the desired minimum distance betweenbony segments 72A-C. In an embodiment, acomposite interbody system 10central fenestration 14 opening maximum length (from front to back) may be about 3 to 15 mm and 7 mm in an embodiment where the maximum length may vary as function of its intended use or placement. Acomposite interbody system 10 may have a maximum width (fromright side 12A toleft side 12B) of about 3 to 15 mm and 8 mm in an embodiment where the maximum width may also vary as function of its intended use or placement. -
FIG. 1C is a simplified front view of acomposite interbody system 10 according to various embodiments. As shown inFIG. 1C , thecomposite interbody system 10front side 12E may includeseveral penetrations penetrations 24A-24C may extendfront side 12E to the centralvertical fenestration 14 and form front side fenestrations. In an embodiment, thecenter fenestration 24C may be threaded to mate with a tool threaded pin. In a further embodiment, one or more of the other penetrations orfenestrations center fenestration 24C and the right and leftfenestrations composite interbody system 10 during implantation between twobony segments 72A-C or removal of the composite interbody system 10 (such as during a revision procedure). In an embodiment, thecomposite interbody system 10 is inserted betweenbony segments 72A-C starting with itsback side 12F. In an embodiment, thefenestrations 24A-C may have a similar diameter of about 0.5 to 5 mm and 1.6 mm in an embodiment such a cervical spine application. Thecenter fenestration 24C may be located about center (from top 12C to bottom 12D and left 12B to right 12A). The other fenestrations 24A, 24B may located centrally from the top 12C to bottom 12D and have a center about 1 mm to 6 mm from thefenestration 24C and about 3 mm in an embodiment. - As shown in
FIG. 1C , thecomposite interbody system 10top side 12C andbottom side 12D may be convexly curved from the approximate center of thefront side 12E. In an embodiment, the effective curvature of thetop side 12C andbottom side 12D measured from its peak (left and right of peak) is about 15 mm to 50 mm and about 30 mm in an embodiment. As shown in 1C, the upper andlower module front extension 46C that is sized to be placed between right and leftshoulders FIG. 2A ) of themain module 20. It is noted that is an embodiment that the upper andlower modules top side 22C layout andbottom side 22D layout may also be identical. -
FIG. 1D is a simplified rear view of acomposite interbody system 10 according to various embodiments. As shown inFIGS. 1A, 1B, and 1D (and others), thecomposite interbody system 10 is sloped from itsfront side 12E to itsback side 12F. In an embodiment, thecomposite interbody system 10 may be sloped about 2 to 12 degrees from itsfront side 12E to backside 12F as function of its intended application and about 6 degrees for a cervical spine application in an embodiment.FIG. 1E is a simplified top view of acomposite interbody system 10 according to various embodiments. As shown inFIG. 1E , thecomposite interbody system 10main module 20 may haspartial shoulders upper module 40A is inset on theright side 12A andleft side 12B and extends to the front 12E and backarea 12F. The upper andlower modules composite interbody system 10fenestration 14 and themain body fenestration 28C. In an embodiment, thecomposite interbody system 10 right 12A and left 12B wall maximum thickness may be about 1 to 5 mm and about 3 mm in an embodiment. In an embodiment, thecomposite interbody system 10 front 12E and back 12F wall maximum thickness may be about 1 to 5 mm and about 2.5 mm in an embodiment. - As shown in
FIGS. 1E and 1F , a substantial portion ofcomposite interbody system 10 top 12C surface area and bottom 12D surface area is provided by the upper andlower modules lower modules vertebrae 72A-C. Further, as show inFIGS. 1A-1J and 3A-3C , the upper andlower modules sized divots holes holes -
FIG. 1F is a simplified bottom view of acomposite interbody system 10 according to various embodiments. As shown inFIG. 1F , thecomposite interbody system 10bottom side 12D may be symmetrical to thecomposite interbody system 10top side 12C.FIG. 1G is a simplifiedright side 12A view of a composite interbody system according to various embodiments.FIG. 1H is a simplifiedleft side view 12B of a composite interbody system according to various embodiments. As shown inFIGS. 1G and 1H , thecomposite interbody system 10right side 12A may be symmetrical to thecomposite interbody system 10left side 12B.FIGS. 1G and 1H also shown how a portion the upper andlower modules 40A dovetails into themain module 20shoulders main module 20shoulders lower modules modules sides main module 20. The linkingmodules 60A (right) and 60B (left) extending through the main body viafenestrations modules modules main module 20. -
FIG. 11 is a simplified vertical cross sectional left side view of thecomposite interbody system 10 shown inFIG. 1C taken along line AA according to various embodiments. As shown inFIG. 11 , themain module 20center fenestration 24C may have threads extending only its entire length.FIG. 1J is a simplified isometric cross sectional view of thecomposite interbody system 10 shown inFIG. 1D taken along line BB according to various embodiments. As shown inFIG. 1J , the linkingmodules shafts main module 20fenestrations modules shafts main module 20fenestrations -
FIG. 2A is a simplified isometric view of amain module 20 of acomposite interbody system 10 according to various embodiments.FIG. 2B is a simplified vertical cross sectional left side view of themain module 20 of acomposite interbody system 10 shown inFIG. 2C taken along line CC according to various embodiments. As discussed and shown inFIGS. 2A and 2B , themain module 20 includes right and leftshoulders 26 B including undercuts 26C. Theundercuts 26C may be sized to enable upper andlower modules -
FIG. 2C is a simplifiedfront view 22E of amain module 20 of acomposite interbody system 10 according to various embodiments. As shown inFIG. 2C , the main body includes afront gap 26E formed by the right and leftshoulders gap 26E is sized to accommodate the upper andlower modules 40 B front extensions 46C.FIG. 2D is a simplifiedrear view 22F of a main module of a composite interbody system according to various embodiments.FIG. 2D shown its top 22C may be symmetrical with itsbottom 22D. As also shown inFIG. 2D , themain module 20shoulders back 22F,top surface 22C to accommodate the upper andlower modules -
FIG. 2E is a simplifiedtop view 22C of amain module 20 of acomposite interbody system 10 according to various embodiments.FIG. 2F is asimplified bottom view 22D of amain module 20 of acomposite interbody system 10 according to various embodiments. As shown inFIGS. 2E and 2F , themain module 20 may include acentral fenestration 28C that is similar or identical in size (length and width) as the upper andlower modules central fenestrations 48C and form thecomposite interbody system 10central fenestration 14. Thecomposite interbody system 10central fenestration 14 may be packed with osteoconductive material including autogenic bone to aid bony fusion betweenbony segments 72A-C where thecomposite interbody system 10 is intended to be deployed. As shown inFIG. 2E , themain module 20central fenestration 28C may convexly curved back, left andright corners 29A and concavely curved front, left andright corners 29B. -
FIG. 2G is a simplified right-side view andFIG. 2H is a simplified left side view of amain module 20 of acomposite interbody system 10 according to various embodiments. As discussed, thecomposite interbody system 10 top 12C and bottom 12D and themain body 10 top 22C and bottom 22D may be sloped downwardly from itsfront side 22E to itsback side 22F, about 6 degrees in an embodiment. The slope inclination from front 12E to back 12F may be selected or configured to match the bony segment surfaces including vertebra lordosis. -
FIG. 3A is a simplified isometric view,FIG. 3B is a simplified front view, andFIG. 3C is a simplified rear view of anupper module 40A of acomposite interbody system 10 according to various embodiments.FIG. 3D is a simplified top view andFIG. 3E is a simplified bottom view of anupper module 40A of acomposite interbody system 10 according to various embodiments.FIG. 3F is a simplified right-side view andFIG. 3G is a simplified left side view of anupper module 40A of acomposite interbody system 10 according to various embodiments. As noted, thelower module 40B may be symmetrical to theupper module 40A and thusFIGS. 3A to 3G may also be views of thelower module 40B in an embodiment. As shown inFIGS. 3A to 3G , the upper andlower modules right side 42A andleft side 42B. The upper andlower modules fenestrations modules shafts heads 64A orcompressed tips 66A. -
FIG. 4A is a simplified isometric front view,FIG. 4B is a simplified isometric bottom view, andFIG. 4C is a simplified right-side view of a lower module to uppermodule linking element 60A of acomposite interbody system 10 according to various embodiments. In an embodiment, the linkingelement 60A may be identical to thelinking module 60B. As shown inFIGS. 4A to 4C , the linkingmodule 60A may include ahead 64A,elongated shaft 62A, andcompressible tip 66A in an embodiment. In an embodiment, thehead 64A diameter may be about 1 mm to 4 mm and about 2.25 mm when theshaft 62B diameter is about 1.5 mm. - The linking
module 60A overall length (fromhead 64A to tip 66A) may vary as a function of thecomposite interbody system 10 height. In an embodiment, the linkingmodules 60A overall length may be about 0.7 mm less than thecomposite interbody system 10 maximum height. The linkingmodule 60A tipopening 68A in theshaft 62A tipupper module 40Aright fenestration 48A. Similarly, the linkingmodule 60B tipopening 68A in theshaft 62A tiplower module 40A left fenestration 48B.Theopening 68A may have a diameter of about 0.2 to 1.5 mm and about 0.8 mm when theshaft 62A diameter is about 1.5 mm. Theopening 68A may have a length of about 0.5 to 3 mm and about 1.5 mm when theshaft 62A diameter is about 1.5 mm. - The accompanying drawings that form a part hereof show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. The embodiments illustrated are described in sufficient detail to enable those skilled in the art to practice the teachings disclosed herein. Other embodiments may be utilized and derived therefrom, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. This Detailed Description, therefore, is not to be taken in a limiting sense, and the scope of various embodiments is defined only by the appended claims, along with the full range of equivalents to which such claims are entitled.
- Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is in fact disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.
- The Abstract of the Disclosure is provided to comply with 37 C.F.R. § 1.72(b), requiring an abstract that will allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. In the foregoing Detailed Description, various features are grouped together in a single embodiment for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted to require more features than are expressly recited in each claim. Rather, inventive subject matter may be found in less than all features of a single disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate embodiment.
Claims (20)
1. A composite interbody system (CIS) for placement between two, adjacent bony mammalian regions, the system including:
a monolithic base comprised of one of a substantially radio-lucent material and a substantially radio-lucent complex of materials (base materials), the base including a top section that is shaped to engage a first segment of the upper bony mammalian region of the two, adjacent bony mammalian regions (upper region) when the CIS is placed therebetween; and
an upper plate comprised of a one of a material and a complex of materials (upper plate materials) that is less radio-lucent than the base materials, the upper plate shaped to nest within the monolithic base and to engage a second segment, different from the first segment of the upper region when the CIS is placed therebetween.
2. The CIS of claim 1 , wherein the combination of the monolithic base and the upper plate are shaped in relief to conform to the upper region when the CIS is placed therebetween.
3. The CIS of claim 1 , wherein the upper plate materials are more osteoconductive than the base materials.
4. The CIS of claim 1 , wherein the upper plate materials consist primarily of titanium and the base materials consist primarily of a member of the polyaryletherketone family.
5. The CIS of claim 1 , wherein the mammalian regions are spinal vertebrae.
6. The CIS of claim 3 , wherein the mammalian regions are spinal vertebrae and the second segment that the upper plate is shaped to engage when the CIS is placed therebetween is cancellous bone.
7. The CIS of claim 1 , wherein the upper plate is shaped to slidably nest within the monolithic base.
8. The CIS of claim 1 , wherein the second segment is larger than the first segment.
9. The CIS of claim 1 , wherein the upper plate is shaped to slidably nest within the monolithic base via a plurality of undercuts in the monolithic base.
10. The CIS of claim 1 , wherein the upper plate is shaped to include a plurality of flanges that slidably nest below a plurality of undercuts in the monolithic base.
11. The CIS of claim 1 , wherein the monolithic base further includes a bottom section that is shaped to engage a first segment of the lower bony mammalian region of the two, adjacent bony mammalian regions (lower region) when the CIS is placed therebetween and further including a lower plate comprised of the same materials as the upper plate materials, the lower plate shaped to nest within the monolithic base and to engage a second segment, different from the first segment of the lower region when the CIS is placed therebetween.
12. The CIS of claim 11 , wherein the combination of the monolithic base and the upper plate are shaped in relief to conform to the upper region and the combination of the monolithic base and the lower plate are shaped in relief to conform to the lower region when the CIS is placed therebetween.
13. The CIS of claim 11 , wherein the upper plate materials are more osteoconductive than the base materials.
14. The CIS of claim 11 , wherein the upper plate materials consist primarily of titanium and the base materials consist primarily of a member of the polyaryletherketone family.
15. The CIS of claim 13 , wherein the mammalian regions are spinal vertebrae and the second segment that the upper plate is shaped to engage and the second segment that the lower plate is shaped to engage when the CIS is placed therebetween is cancellous bone.
16. The CIS of claim 11 , wherein the upper plate is shaped to slidably nest within an upper region of the monolithic base and the lower plate is shaped to slidably nest within a lower region of the monolithic base.
17. The CIS of claim 11 , wherein the upper second segment is larger than the upper first segment and the lower second segment is larger than the lower first segment.
18. The CIS of claim 11 , wherein the upper plate is shaped to slidably nest within an upper region of the monolithic base via a plurality of undercuts in the upper region of the monolithic base and the lower plate is shaped to slidably nest within a lower region of the monolithic base via a plurality of undercuts in the lower region of the monolithic base.
19. The CIS of claim 11 , wherein the upper plate is shaped to include a plurality of flanges that slidably nest below a plurality of undercuts in an upper region of the monolithic base and the lower plate is shaped to include a plurality of flanges that slidably nest below a plurality of undercuts in a lower region of the monolithic base.
20. The CIS of claim 1 , further including a linking element fixably coupling the upper plate to the lower plate via a fenestration in the monolithic base.
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US16/864,485 US20210077269A1 (en) | 2017-02-08 | 2020-05-01 | Composite interbody system |
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US15/428,138 US10675159B2 (en) | 2017-02-08 | 2017-02-08 | Composite interbody system |
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EP3662870A1 (en) | 2018-12-05 | 2020-06-10 | SMed - TA/TD LLC | Adjusted stiffness orthopaedic implants and method of manufacture |
US11051953B2 (en) * | 2019-07-31 | 2021-07-06 | Zavation Medical Products, Llc | Porous spinal implant |
US11857436B1 (en) | 2019-07-31 | 2024-01-02 | Zavation Medical Products, Llc | Porous spinal implant |
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AU624627B2 (en) * | 1988-08-18 | 1992-06-18 | Johnson & Johnson Orthopaedics, Inc. | Functional and biocompatible intervertebral disc spacer containing elastomeric material of varying hardness |
US6569201B2 (en) * | 2001-09-28 | 2003-05-27 | Depuy Acromed, Inc. | Hybrid composite interbody fusion device |
US6726720B2 (en) * | 2002-03-27 | 2004-04-27 | Depuy Spine, Inc. | Modular disc prosthesis |
JP5175049B2 (en) * | 2003-10-20 | 2013-04-03 | ブラックストーン メディカル,インコーポレイティド | Vertebral replacement device and method |
US8562685B2 (en) * | 2005-05-06 | 2013-10-22 | Titan Spine, Llc | Spinal implant and integration plate for optimizing vertebral endplate contact load-bearing edges |
CN101272750A (en) * | 2005-09-26 | 2008-09-24 | 华沙整形外科股份有限公司 | Transforaminal hybrid implant |
US20080154379A1 (en) * | 2006-12-22 | 2008-06-26 | Musculoskeletal Transplant Foundation | Interbody fusion hybrid graft |
US20100094426A1 (en) * | 2008-10-14 | 2010-04-15 | Grohowski Jr Joseph A | Hybrid intervertebral spinal implant |
US8303879B2 (en) * | 2010-02-01 | 2012-11-06 | Sb Technologies, Llc | Composite interbody device and method of manufacture |
US9770340B2 (en) * | 2011-09-16 | 2017-09-26 | Globus Medical, Inc. | Multi-piece intervertebral implants |
US8454700B2 (en) * | 2011-10-04 | 2013-06-04 | Zimmer Spine, Inc. | Interbody vertebral spacer |
US8992619B2 (en) * | 2011-11-01 | 2015-03-31 | Titan Spine, Llc | Microstructured implant surfaces |
US9238319B2 (en) * | 2013-03-14 | 2016-01-19 | DePuy Synthes Products, Inc. | Hybrid intervertebral disc spacer device and method of manufacturing the same |
US9693874B2 (en) * | 2013-03-15 | 2017-07-04 | Blackstone Medical, Inc. | Composite spinal interbody device and method |
TWI548429B (en) * | 2014-11-07 | 2016-09-11 | 財團法人工業技術研究院 | Medical composite material method for fabricating the same and applications thereof |
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