US20230293311A1 - Standalone anterior lumber interbody spacer - Google Patents
Standalone anterior lumber interbody spacer Download PDFInfo
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- US20230293311A1 US20230293311A1 US18/201,178 US202318201178A US2023293311A1 US 20230293311 A1 US20230293311 A1 US 20230293311A1 US 202318201178 A US202318201178 A US 202318201178A US 2023293311 A1 US2023293311 A1 US 2023293311A1
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- Prior art keywords
- spacer
- fixation plate
- spring loaded
- interbody spacer
- lumbar
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- 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
-
- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/442—Intervertebral or spinal discs, e.g. resilient
-
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- 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
- 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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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2002/30476—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2002/30476—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism
- A61F2002/30505—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism spring biased
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2002/30476—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism
- A61F2002/30507—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism using a threaded locking member, e.g. a locking screw or a set screw
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2002/30476—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism
- A61F2002/30517—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism using a locking plate
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30576—Special structural features of bone or joint prostheses not otherwise provided for with extending fixation tabs
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30576—Special structural features of bone or joint prostheses not otherwise provided for with extending fixation tabs
- A61F2002/30578—Special structural features of bone or joint prostheses not otherwise provided for with extending fixation tabs having apertures, e.g. for receiving fixation screws
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30593—Special structural features of bone or joint prostheses not otherwise provided for hollow
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30604—Special structural features of bone or joint prostheses not otherwise provided for modular
- A61F2002/30616—Sets comprising a plurality of prosthetic parts of different sizes or orientations
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Definitions
- the present invention relates generally to the field of surgery, and more specifically, to an anterior lumbar interbody spacer for placement in intervertebral space between adjacent vertebrae during anterior lumbar spinal fixation.
- a spinal disc can become damaged as a result of degeneration, dysfunction, disease and/or trauma.
- Conservative treatment can include non-operative treatment through exercise and/or pain relievers to deal with the pain.
- Operative treatment options include disc removal and replacement using an interbody spacers such as anterior cervical interbody fusion (ACIF), anterior lumbar interbody fusion (ALIF), direct lateral interbody fusion (DLIF) (also known as XLIF), posterior lumbar interbody fusion (PLIF), and transforaminal lumbar interbody fusion (TLIF).
- ACIF anterior cervical interbody fusion
- ALIF anterior lumbar interbody fusion
- DLIF direct lateral interbody fusion
- PLIF posterior lumbar interbody fusion
- TLIF transforaminal lumbar interbody fusion
- interbody spacers are placed in the interdiscal space between adjacent vertebrae of the spine, resulting in spinal fusion of the adjacent vertebra wherein two or more vertebrae are joined together (fused) by way of interbody spacers, sometimes with bone grafting, to form a single bone.
- the current standard of care for interbody fusion requires surgical removal of all or a portion of the intervertebral disc. After removal of the intervertebral disc, the interbody spacer is inserted in the space between the adjacent vertebrae.
- the interbody spacer should stabilize the intervertebral space and allow fusion of the adjacent vertebrae. Moreover, during the time it takes for fusion to occur, the interbody spacer body should have sufficient structural integrity to withstand the stress of maintaining the space without substantially degrading or deforming and have sufficient stability to remain securely in place prior to actual bone ingrowth fusion.
- interbody spacers are typically one piece that are assembled at the manufacturing stage. Many different sizes are made, which results in a large inventory of plate/spacer body combinations, as well as large sterilization/shipping caddies to facilitate transfer of spacers large interbody spacers.
- typical interbody spacers require a secondary element to install the plate in-situ to inhibit fixation screw migration. This secondary action is time consuming and cumbersome when the surgical procedure is time sensitive.
- a standalone anterior lumbar interbody spacer that includes a lumbar spacer body and lumbar plate with a unique locking system that rigidly couples the spacer body and plate via a spring loaded lock tab.
- the locking system include locking features designed to engage with the spring loaded lock tab to lock the lumbar spacer body and lumbar plate together.
- the locking features are part of the lumbar plate protrusion having tab distraction geometry and lock geometry.
- the tab distraction geometry includes an inclined or ramped portion and the lock geometry includes a tab recess or pocket.
- the distraction geometry is such that as the spacer body and plate are coupled, the inclined or ramped portion will engage spring loaded lock tab and push the spring loaded lock tab in so that is can slide on the surface.
- the spring loaded lock tab reaches the tab recess or pocket, allowing the spring loaded lock tab to return to its original position within the recess or pocket, thereby locking the lumbar spacer body and lumbar plate.
- the tab engaging the recess may provide an audible click sound the let the user know that the parts are joined and locked together.
- FIGS. 1 A- 1 C show various configurations or variations of a modular lumbar interbody spacer having a lumbar spacer body coupled with different lumbar plates.
- FIGS. 2 A- 2 C show various configurations or variations of a lumbar interbody spacer with different lumbar spacer body footprints or configurations coupled with a lumbar plate.
- FIG. 3 shows an exploded perspective view showing one embodiment of an anterior lumbar interbody spacer
- FIG. 4 shows a proximal view of the lumbar spacer body showing locking geometry
- FIG. 5 shows a sectional view at A-A of the lumbar spacer body shown in FIG. 4 .
- FIG. 6 shows a distal end of the lumbar plate.
- FIG. 7 shows a sectional view at B-B of the lumbar plate shown in FIG. 6 .
- FIG. 8 shows the assembly of the lumbar plate into the lumbar spacer body.
- FIG. 9 shows a perspective view of the anterior lumbar interbody spacer.
- FIG. 10 shows a sectional view of the anterior lumbar interbody spacer at C-C of FIG. 9 .
- FIG. 11 shows assembly of the anterior lumbar interbody spacer.
- FIG. 12 shows the anterior lumbar interbody spacer 100 in the implanted configuration.
- FIGS. 13 A- 13 C show different embodiments of bone screw locking features.
- FIG. 14 shows an implant disassembly tool.
- FIG. 15 shows a sectional view of the implant disassembly tool disengaging the spring loaded lock tab.
- the invention is direct to an anterior lumbar interbody spacer that is a modular two piece design comprising a lumbar spacer body and plate that are designed to lock together via a lock tab.
- each of the components are provided in various sizes and configurations so that the surgeon can pick or choose the desired spacer body configuration and size. The surgeon can then select the desired plate configuration and join the two together.
- the lumbar spacer body and plate have engagement features that are configured to rigidly couple them together via the lock tab to form the anterior lumbar interbody spacer.
- FIGS. 1 A- 1 C show three configurations or variations of a modular anterior lumbar interbody spacer 100 comprising a lumbar spacer body 102 coupled with different lumbar plate 104 configurations or profile options.
- FIG. 1 A shows a Zero 104 a
- FIG. 1 B shows a Half 104 b
- FIG. 1 C shows a Full 104c.
- FIGS. 2 A- 2 C show three configurations or variations of an anterior lumbar interbody spacer 100 comprising a three different lumbar spacer body footprints or configurations coupled with a lumbar plate 104 .
- the lumbar spacer body configurations may include various footprints having different widths W, depths D, heights and sagittal profiles.
- FIG. 2 A shows a lumbar spacer body 102 a with a 24 ⁇ 30 mm footprint
- FIG. 2 B shows a lumbar spacer body 102 b with a 26 ⁇ 34 mm footprint
- the heights of the spacer bodies may include five heights from 10 mm-18 mm @2 mm increments, and three sagittal profiles, 7°, 12°, 30°.
- FIG. 3 is an exploded perspective view showing an anterior lumber interbody spacer 100 comprising a lumbar spacer body 102 and a lumbar plate 104 having coupling features to rigidly affixed the lumbar spacer body 102 to the lumbar plate 104 .
- the lumbar spacer body 102 is generally rectangular is shape with a proximal end 106 and a distal end 108 connected by lateral sides 110 , 112 with one or more central openings 114 .
- the lumbar spacer body 102 further includes a central wall 116 between the proximal and distal ends 106 , 108 .
- the lumbar spacer body further includes an upper surface 118 and lower surface 120 .
- the upper and lower surfaces 118 , 120 may include teeth 122 , such as Pyramidal Teeth. In some embodiments the surfaces may be roughened acid etch or blasted.
- the proximal end 106 of the lumbar spacer body 102 includes a slot 124 .
- the slot 124 may be a vertical slot from the upper surface.
- the lumbar plate 104 includes a proximal end 107 , a distal end 109 and right and left sides 130 , 132 .
- the plate further includes an upper surface 134 and lower surface 136 .
- the upper and lower surfaces 134 , 136 may include teeth 138 as pyramidal teeth. In some embodiments the surfaces may be roughened acid etch or blasted.
- the distal end 107 includes a protrusion 140 .
- FIG. 4 shows the proximal end 106 of the lumbar spacer body 102 and FIG. 5 is a cross-sectional view at A-A of the lumbar spacer body 102 .
- the lumbar spacer body 102 having a spring loaded lock tab 126 configured to engage the protrusion 140 and coupled with a locking feature 154 .
- the spring loaded lock tab 126 is coupled with a retaining pin 128 and a spring 129 .
- the retaining pin 128 may be made of nitinol and the spring 129 may be elgiloy.
- the retaining pin 128 is positioned in a slotted portion of the spring loaded lock tab 126 to retain the spring loaded lock tab 126 and limit the inward and outward travel.
- the spring loaded lock tab 126 , retaining pin 128 and spring 129 are slidable into a bore or hole 125 in the lumbar spacer body 102 .
- the spring loaded lock tab 126 includes a ramped surface
- FIG. 6 shows the distal end 125 of the lumbar plate 104 and FIG. 7 is a cross-sectional view of the lumbar plate 102 .
- the protrusion 140 of the lumbar plate 104 may include distraction geometry 152 and lock geometry 154 .
- FIG. 8 shows the assembly of the lumbar plate 104 into the lumbar spacer body 102 .
- the protrusion 140 is inserted into the slot 124 .
- the distraction geometry of the lumbar plate 104 includes a tab compression portion and a tab locking portion.
- the tab compression portion includes an inclined or ramped portion 156 and the tab locking portion includes a tab engagement recess or tab lock recess 158 .
- the inclined or ramped portion 156 engages the ramped surface 127 of the spring loaded lock tab 126 and forces the spring loaded lock tab 126 to slide inward against the spring 129 .
- the spring loaded lock tab 126 reaches the lock geometry recess or pocket 158 , allowing the spring loaded lock tab 126 to return to its original position, thereby locking the lumbar plate 104 to the lumbar spacer body 102 .
- the movement of the spring loaded lock tab 126 into the geometry recess or pocket 158 may provide an audible click sound the let the user know that the parts are joined and locked together.
- FIG. 9 is a perspective view of the anterior lumbar interbody spacer 100 and FIG. 10 is a sectional view showing the lumbar plate 104 coupled with the lumbar spacer body 102 .
- the lumbar spacer body 102 is shown as transparent to show features of the spring loaded lock tab 126 .
- the spring loaded lock tab 126 includes a slot 160 sized for the retaining pin 128 .
- the slot 160 retains the spring loaded lock tab 126 in the bore 125 and limits the inward and outward movement.
- the spring loaded lock tab 126 is also coupled to the spring 129 .
- the spring 129 supplies a force to the spring loaded lock tab 126 so that the spring loaded lock tab 126 is naturally in the outward position.
- the spring loaded lock tab 126 When the spring loaded lock tab 126 engages the protrusion 140 , the spring loaded lock tab 126 compresses the spring 129 . Once the spring loaded lock tab 126 reaches the pocket 158 , the spring forces the spring loaded lock tab 126 to the outward position within the pocket 158 , locking the lumbar plate 104 with the lumbar spacer body 102 .
- the anterior lumbar interbody spacer 100 will utilize PEEK or titanium (TI) lumbar spacer body 102 in conjunction with a titanium (TI) lumbar plate 104 .
- Lumbar plate 104 a includes three fastener holes 150 , two fastener holes are tilted at an upward angle so that the engagement fastener engages the vertebra above the anterior lumbar interbody spacer 100 and the other fastener hole is tilted at a downward angle so that the bone engagement fastener engages the vertebra below the anterior lumbar interbody spacer 100 .
- Lumbar plate 104 b includes three fastener holes, a center fastener hole tilted at a downward angle so that the bone engagement fastener engages the vertebra below the lumbar spacer body 102 and two outer holes are tilted at an upward angle so that the engagement fasteners engage the vertebra above the lumbar spacer body 102 .
- Lumbar plate 104 c includes four fastener holes, an upper pair of fastener holes tilted at an upward angle so that the engagement fasteners engage the vertebra above the lumbar spacer body 102 and a lower pair of fastener holes tilted at a downward angle so that the bone engagement fasteners engage the vertebra below the lumbar spacer body 102 .
- FIG. 11 shows assembly of the anterior lumbar interbody spacer 100 that may be assembled on the back table in the operating room (OR).
- the anterior lumbar interbody spacer 100 can be assembled from a variety of lumbar plates 104 , such as 140 a , 104 b or 104 c , and lumbar spacer body 102 , such as 102 a , 102 b , 102 c
- the protrusion 140 of the lumbar plate 104 is slid into the slot 124 of the lumbar spacer body 102 in a vertical direction.
- the geometry of the protrusion 140 is such that it will force the spring loaded lock tab 126 to distract into a bore 125 in the spacer body.
- the lock geometry 154 on the lumbar plate 104 will allow for the spring loaded tab 126 to return to its original position in pocket 158 , thereby locking the lumbar plate 104 with the lumbar spacer body 102 .
- Engaging the recess 158 may provide an audible click sound the let the user know that the parts are joined and locked together.
- FIG. 12 shows the anterior lumbar interbody spacer 100 in the implanted configuration.
- the lumbar plate 104 includes two more fastener holes 150 sized to receive bone engagement fasteners 152 configured to anchor the anterior lumbar interbody spacer 100 between two vertebrae of the spine.
- FIGS. 13 A- 13 C show different embodiments of bone screw locking features, such as a single hole locking feature 154 or a double hole locking feature 156 , covering a portion of the hole 150 . to prevent the bone fasteners 152 from withdrawing from the fastener holes 150 .
- FIG. 13 A shows lumbar plate 104 a having three fastener holes 150 and three locking features 154 positioned near the fastener holes 150 with a portion of the locking feature, such as a head portion, covering part of the fastener holes 150 .
- FIG. 13 B shows lumbar plate 104 b having three fastener holes 150 and both the single hole locking feature 154 and double hole locking feature 156 three locking features shows use of both single hole locking feature 154 and double hole locking feature 156 .
- FIG. 13 C shows lumbar plate 104 c having four fastener holes 150 and two double hole locking feature 156 c.
- the present invention requires relatively small amounts of assembly force due to the elasticity of the spring loaded tab and spring, in addition, the tab can be easily distracted utilizing a secondary instrument, allowing for simple and fast implant disassembly.
- FIG. 14 shows an implant disassembly tool 156 that is used to disengage the spring loaded lock tab 126 for implant disassembly shown in FIG. 15 .
- the implant disassembly tool 156 is inserted through a hole in the lumbar plate and pushes the spring loaded lock tab 126 to disengage the lumbar plate 104 from the lumbar spacer body 102 , pushing the spring loaded lock tab 126 into.
Abstract
Disclosed is a standalone anterior lumbar interbody spacer that includes a lumbar spacer body and lumbar plate with a unique locking system to rigidly couple the spacer body and plate via a spring loaded lock tab.
Description
- This application is a continuation of U.S. application Ser. No. 17/031,885, filed Sep. 24, 2020, which claims the benefit of U.S. Provisional Application No. 62/905,384 filed Sep. 24, 2019, all of which are incorporated herein by reference.
- The present invention relates generally to the field of surgery, and more specifically, to an anterior lumbar interbody spacer for placement in intervertebral space between adjacent vertebrae during anterior lumbar spinal fixation.
- A spinal disc can become damaged as a result of degeneration, dysfunction, disease and/or trauma. Conservative treatment can include non-operative treatment through exercise and/or pain relievers to deal with the pain. Operative treatment options include disc removal and replacement using an interbody spacers such as anterior cervical interbody fusion (ACIF), anterior lumbar interbody fusion (ALIF), direct lateral interbody fusion (DLIF) (also known as XLIF), posterior lumbar interbody fusion (PLIF), and transforaminal lumbar interbody fusion (TLIF).
- The interbody spacers are placed in the interdiscal space between adjacent vertebrae of the spine, resulting in spinal fusion of the adjacent vertebra wherein two or more vertebrae are joined together (fused) by way of interbody spacers, sometimes with bone grafting, to form a single bone. The current standard of care for interbody fusion requires surgical removal of all or a portion of the intervertebral disc. After removal of the intervertebral disc, the interbody spacer is inserted in the space between the adjacent vertebrae.
- Ideally, the interbody spacer should stabilize the intervertebral space and allow fusion of the adjacent vertebrae. Moreover, during the time it takes for fusion to occur, the interbody spacer body should have sufficient structural integrity to withstand the stress of maintaining the space without substantially degrading or deforming and have sufficient stability to remain securely in place prior to actual bone ingrowth fusion.
- The interbody spacers are typically one piece that are assembled at the manufacturing stage. Many different sizes are made, which results in a large inventory of plate/spacer body combinations, as well as large sterilization/shipping caddies to facilitate transfer of spacers large interbody spacers. In addition, typical interbody spacers require a secondary element to install the plate in-situ to inhibit fixation screw migration. This secondary action is time consuming and cumbersome when the surgical procedure is time sensitive.
- Some prior art designs utilized titanium arms for distraction, this places a large amount of force on the PEEK spacer body, potentially damaging the spacer during assembly. This increased distraction force requires a large assembly tool to overcome the titanium arms and makes disassembly difficult.
- It would be desirable to provide an interbody spacer with modularity and functionality to decreased inventory size.
- Disclosed is a standalone anterior lumbar interbody spacer that includes a lumbar spacer body and lumbar plate with a unique locking system that rigidly couples the spacer body and plate via a spring loaded lock tab.
- The locking system include locking features designed to engage with the spring loaded lock tab to lock the lumbar spacer body and lumbar plate together. The locking features are part of the lumbar plate protrusion having tab distraction geometry and lock geometry. The tab distraction geometry includes an inclined or ramped portion and the lock geometry includes a tab recess or pocket. The distraction geometry is such that as the spacer body and plate are coupled, the inclined or ramped portion will engage spring loaded lock tab and push the spring loaded lock tab in so that is can slide on the surface. Once the plate and spacer body are completely joined, the spring loaded lock tab reaches the tab recess or pocket, allowing the spring loaded lock tab to return to its original position within the recess or pocket, thereby locking the lumbar spacer body and lumbar plate. The tab engaging the recess may provide an audible click sound the let the user know that the parts are joined and locked together.
-
FIGS. 1A-1C show various configurations or variations of a modular lumbar interbody spacer having a lumbar spacer body coupled with different lumbar plates. -
FIGS. 2A-2C show various configurations or variations of a lumbar interbody spacer with different lumbar spacer body footprints or configurations coupled with a lumbar plate. -
FIG. 3 shows an exploded perspective view showing one embodiment of an anterior lumbar interbody spacer -
FIG. 4 shows a proximal view of the lumbar spacer body showing locking geometry -
FIG. 5 shows a sectional view at A-A of the lumbar spacer body shown inFIG. 4 . -
FIG. 6 shows a distal end of the lumbar plate. -
FIG. 7 shows a sectional view at B-B of the lumbar plate shown inFIG. 6 . -
FIG. 8 shows the assembly of the lumbar plate into the lumbar spacer body. -
FIG. 9 shows a perspective view of the anterior lumbar interbody spacer. -
FIG. 10 shows a sectional view of the anterior lumbar interbody spacer at C-C ofFIG. 9 . -
FIG. 11 shows assembly of the anterior lumbar interbody spacer. -
FIG. 12 shows the anteriorlumbar interbody spacer 100 in the implanted configuration. -
FIGS. 13A-13C show different embodiments of bone screw locking features. -
FIG. 14 shows an implant disassembly tool. -
FIG. 15 shows a sectional view of the implant disassembly tool disengaging the spring loaded lock tab. - The invention is direct to an anterior lumbar interbody spacer that is a modular two piece design comprising a lumbar spacer body and plate that are designed to lock together via a lock tab. With this design, each of the components are provided in various sizes and configurations so that the surgeon can pick or choose the desired spacer body configuration and size. The surgeon can then select the desired plate configuration and join the two together. The lumbar spacer body and plate have engagement features that are configured to rigidly couple them together via the lock tab to form the anterior lumbar interbody spacer.
-
FIGS. 1A-1C show three configurations or variations of a modular anteriorlumbar interbody spacer 100 comprising alumbar spacer body 102 coupled withdifferent lumbar plate 104 configurations or profile options. For example,FIG. 1A shows a Zero 104 a,FIG. 1B shows aHalf 104 b, andFIG. 1C shows a Full 104c. -
FIGS. 2A-2C show three configurations or variations of an anteriorlumbar interbody spacer 100 comprising a three different lumbar spacer body footprints or configurations coupled with alumbar plate 104. The lumbar spacer body configurations may include various footprints having different widths W, depths D, heights and sagittal profiles. For example,FIG. 2A shows alumbar spacer body 102 a with a 24×30 mm footprint,FIG. 2B shows alumbar spacer body 102 b with a 26×34 mm footprint, andFIG. 2C shows alumbar spacer body 102 c with a 28×38 mm footprint, the heights of the spacer bodies may include five heights from 10 mm-18 mm @2 mm increments, and three sagittal profiles, 7°, 12°, 30°. -
FIG. 3 is an exploded perspective view showing an anteriorlumber interbody spacer 100 comprising alumbar spacer body 102 and alumbar plate 104 having coupling features to rigidly affixed thelumbar spacer body 102 to thelumbar plate 104. - The
lumbar spacer body 102 is generally rectangular is shape with aproximal end 106 and adistal end 108 connected bylateral sides central openings 114. In the embodiments shown, thelumbar spacer body 102 further includes acentral wall 116 between the proximal anddistal ends upper surface 118 andlower surface 120. The upper andlower surfaces teeth 122, such as Pyramidal Teeth. In some embodiments the surfaces may be roughened acid etch or blasted. Theproximal end 106 of thelumbar spacer body 102 includes aslot 124. Theslot 124 may be a vertical slot from the upper surface. - The
lumbar plate 104 includes aproximal end 107, adistal end 109 and right and leftsides upper surface 134 and lower surface 136. The upper andlower surfaces 134, 136 may includeteeth 138 as pyramidal teeth. In some embodiments the surfaces may be roughened acid etch or blasted. Thedistal end 107 includes aprotrusion 140. -
FIG. 4 shows theproximal end 106 of thelumbar spacer body 102 andFIG. 5 is a cross-sectional view at A-A of thelumbar spacer body 102. Thelumbar spacer body 102 having a spring loadedlock tab 126 configured to engage theprotrusion 140 and coupled with a locking feature 154. The spring loadedlock tab 126 is coupled with a retainingpin 128 and aspring 129. The retainingpin 128 may be made of nitinol and thespring 129 may be elgiloy. The retainingpin 128 is positioned in a slotted portion of the spring loadedlock tab 126 to retain the spring loadedlock tab 126 and limit the inward and outward travel. The spring loadedlock tab 126, retainingpin 128 andspring 129 are slidable into a bore orhole 125 in thelumbar spacer body 102. The spring loadedlock tab 126 includes a rampedsurface 127. -
FIG. 6 shows thedistal end 125 of thelumbar plate 104 andFIG. 7 is a cross-sectional view of thelumbar plate 102. Theprotrusion 140 of thelumbar plate 104 may includedistraction geometry 152 and lock geometry 154. -
FIG. 8 shows the assembly of thelumbar plate 104 into thelumbar spacer body 102. Theprotrusion 140 is inserted into theslot 124. - The distraction geometry of the
lumbar plate 104 includes a tab compression portion and a tab locking portion. The tab compression portion includes an inclined or rampedportion 156 and the tab locking portion includes a tab engagement recess ortab lock recess 158. As theprotrusion 140 is slid into the slot 146, the inclined or rampedportion 156 engages the rampedsurface 127 of the spring loadedlock tab 126 and forces the spring loadedlock tab 126 to slide inward against thespring 129. Once thelumbar plate 104 andlumbar spacer body 102 are completely joined, the spring loadedlock tab 126 reaches the lock geometry recess orpocket 158, allowing the spring loadedlock tab 126 to return to its original position, thereby locking thelumbar plate 104 to thelumbar spacer body 102. The movement of the spring loadedlock tab 126 into the geometry recess orpocket 158 may provide an audible click sound the let the user know that the parts are joined and locked together. -
FIG. 9 is a perspective view of the anteriorlumbar interbody spacer 100 andFIG. 10 is a sectional view showing thelumbar plate 104 coupled with thelumbar spacer body 102. Thelumbar spacer body 102 is shown as transparent to show features of the spring loadedlock tab 126. The spring loadedlock tab 126 includes aslot 160 sized for the retainingpin 128. Theslot 160 retains the spring loadedlock tab 126 in thebore 125 and limits the inward and outward movement. The spring loadedlock tab 126 is also coupled to thespring 129. Thespring 129 supplies a force to the spring loadedlock tab 126 so that the spring loadedlock tab 126 is naturally in the outward position. When the spring loadedlock tab 126 engages theprotrusion 140, the spring loadedlock tab 126 compresses thespring 129. Once the spring loadedlock tab 126 reaches thepocket 158, the spring forces the spring loadedlock tab 126 to the outward position within thepocket 158, locking thelumbar plate 104 with thelumbar spacer body 102. - In some embodiments, the anterior
lumbar interbody spacer 100 will utilize PEEK or titanium (TI)lumbar spacer body 102 in conjunction with a titanium (TI)lumbar plate 104. -
Lumbar plate 104 a includes threefastener holes 150, two fastener holes are tilted at an upward angle so that the engagement fastener engages the vertebra above the anteriorlumbar interbody spacer 100 and the other fastener hole is tilted at a downward angle so that the bone engagement fastener engages the vertebra below the anteriorlumbar interbody spacer 100.Lumbar plate 104 b includes three fastener holes, a center fastener hole tilted at a downward angle so that the bone engagement fastener engages the vertebra below thelumbar spacer body 102 and two outer holes are tilted at an upward angle so that the engagement fasteners engage the vertebra above thelumbar spacer body 102.Lumbar plate 104 c includes four fastener holes, an upper pair of fastener holes tilted at an upward angle so that the engagement fasteners engage the vertebra above thelumbar spacer body 102 and a lower pair of fastener holes tilted at a downward angle so that the bone engagement fasteners engage the vertebra below thelumbar spacer body 102. -
FIG. 11 shows assembly of the anteriorlumbar interbody spacer 100 that may be assembled on the back table in the operating room (OR). The anteriorlumbar interbody spacer 100 can be assembled from a variety oflumbar plates 104, such as 140 a, 104 b or 104 c, andlumbar spacer body 102, such as 102 a, 102 b, 102 c To assemble the anteriorlumbar interbody spacer 100, theprotrusion 140 of thelumbar plate 104 is slid into theslot 124 of thelumbar spacer body 102 in a vertical direction. The geometry of theprotrusion 140 is such that it will force the spring loadedlock tab 126 to distract into abore 125 in the spacer body. Once thelumbar plate 104 has been sufficiently inserted into thelumbar spacer body 102, the lock geometry 154 on thelumbar plate 104 will allow for the spring loadedtab 126 to return to its original position inpocket 158, thereby locking thelumbar plate 104 with thelumbar spacer body 102. Engaging therecess 158 may provide an audible click sound the let the user know that the parts are joined and locked together. -
FIG. 12 shows the anteriorlumbar interbody spacer 100 in the implanted configuration. Thelumbar plate 104 includes twomore fastener holes 150 sized to receivebone engagement fasteners 152 configured to anchor the anteriorlumbar interbody spacer 100 between two vertebrae of the spine. -
FIGS. 13A-13C show different embodiments of bone screw locking features, such as a single hole locking feature 154 or a doublehole locking feature 156, covering a portion of thehole 150. to prevent thebone fasteners 152 from withdrawing from the fastener holes 150.FIG. 13A showslumbar plate 104 a having threefastener holes 150 and three locking features 154 positioned near the fastener holes 150 with a portion of the locking feature, such as a head portion, covering part of the fastener holes 150.FIG. 13B showslumbar plate 104 b having threefastener holes 150 and both the single hole locking feature 154 and double hole locking feature 156 three locking features shows use of both single hole locking feature 154 and doublehole locking feature 156.FIG. 13C showslumbar plate 104 c having fourfastener holes 150 and two double hole locking feature 156 c. - The present invention requires relatively small amounts of assembly force due to the elasticity of the spring loaded tab and spring, in addition, the tab can be easily distracted utilizing a secondary instrument, allowing for simple and fast implant disassembly.
-
FIG. 14 shows animplant disassembly tool 156 that is used to disengage the spring loadedlock tab 126 for implant disassembly shown inFIG. 15 . Theimplant disassembly tool 156 is inserted through a hole in the lumbar plate and pushes the spring loadedlock tab 126 to disengage thelumbar plate 104 from thelumbar spacer body 102, pushing the spring loadedlock tab 126 into. - Example embodiments of the methods and systems of the present invention have been described herein. As noted elsewhere, these example embodiments have been described for illustrative purposes only and are not limiting. Other embodiments are possible and are covered by the invention. Such embodiments will be apparent to persons skilled in the relevant art(s) based on the teachings contained herein. Thus, the breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments but should be defined only in accordance with the following claims and their equivalents.
Claims (19)
1. A modular interbody spacer for placement between adjacent vertebrae comprising:
a spacer body having upper and lower vertebrae engagement surfaces and a vertical slot from the upper surface with a bore or hole;
a locking system slidable within the bore or hole; and
a fixation plate having upper and lower bone vertebrae surfaces and a protrusion configured to slidably insert in the vertical slot in a vertical direction and engage the locking system, the locking system being configured to lock the fixation plate to the spacer body in a completely joined position.
2. The modular interbody spacer of claim 1 , wherein the locking system includes a spring loaded lock tab.
3. The modular interbody spacer of claim 2 , wherein the protrusion includes a first portion configured to compress the spring loaded lock tab during the vertical insertion, and a second portion configured to lock the spring loaded lock tab when the fixation plate and spacer body are in the completely joined position.
4. The modular interbody spacer of claim 3 , wherein the first portion of the protrusion includes an inclined or ramped portion configured to engage and move the spring loaded lock tab inward in the bore or hole.
5. The modular interbody spacer of claim 3 , wherein the second portion of the protrusion includes a tab engagement recess configured to engage and allow the spring loaded lock tab to move outward from the bore and lock the spring loaded lock tab.
6. The modular interbody spacer of claim 1 , wherein the locking system is configured to provide an audible click when the fixation plate is locked to the spacer body.
7. The modular interbody spacer of claim 1 , wherein the fixation plate includes a hole configured to receive a disassembly tool to disengage the locking system and unlock the fixation plate from the spacer body.
8. The modular interbody spacer of claim 1 , wherein the vertical slot is position on a proximal end of the spacer plate and the protrusion is positioned on a distal end of the fixation plate.
9. The modular interbody spacer of claim 1 , wherein the fixation plate includes one or more fastener holes on a proximal end sized to receive a bone engagement fastener to attach the fixation plate to:
the vertebra above or below the spacer body, or
both the vertebra above and below the spacer body.
10. The modular interbody spacer of claim 10 , wherein the fixation plate includes bone screw locking features configured to cover a portion of the fastener holes to prevent the bones screws from withdrawing from the fastener holes.
11. A modular interbody spacer for placement between adjacent vertebrae comprising:
a spacer body having upper and lower vertebrae engagement surfaces and a vertical slot from the upper surface with a bore or hole;
a spring loaded lock tab and a spring slidable within the bore or hole; and
a fixation plate having upper and lower bone vertebrae surfaces and a protrusion configured to slidably insert in the vertical slot in a vertical direction and engage the spring loaded lock tab and spring, the spring loaded lock tab and spring being configured to lock the fixation plate to the spacer body in a completely joined position.
12. The modular interbody spacer of claim 11 , wherein the vertical slot is position on a proximal end of the spacer plate and the protrusion is positioned on a distal end of the fixation plate.
13. The modular interbody spacer of claim 11 , wherein the protrusion includes a first portion configured to compress the spring loaded lock tab during the vertical insertion, and a second portion configured to lock the spring loaded lock tab when the fixation plate and spacer body are in the completely joined position.
14. The modular interbody spacer of claim 13 , wherein the first portion of the protrusion includes an inclined or ramped portion configured to engage and move the spring loaded lock tab and spring inward in the bore or hole.
15. The modular interbody spacer of claim 13 , wherein the second portion of the protrusion includes a tab engagement recess configured to engage and allow the spring loaded lock tab and spring to move outward from the bore and lock the spring loaded lock tab.
16. A modular interbody spacer for placement between adjacent vertebrae comprising:
a spacer body having a vertical slot with a bore or hole;
a locking system slidable within the bore or hole; and
a fixation plate having a protrusion configured to slidably insert vertically in the vertical slot and engage the locking system, the locking system configured to lock the fixation plate to the spacer body in a joined position.
17. The modular interbody spacer of claim 16 , wherein the spacer body includes upper and lower vertebrae engagement surfaces, and the fixation plate includes upper and lower bone vertebrae surfaces.
19. The modular interbody spacer of claim 18, wherein the fixation plate includes at least one fastener hole tilted at an upward angle so that a bone screw engages the vertebra above the modular interbody spacer, and at least one fastener hole tilted at a downward angle so that a bone screw engages the vertebra below the modular interbody spacer.
20. The modular interbody spacer of claim 19 , wherein the fixation plate includes bone screw locking features configured to cover a portion of the fastener holes to prevent the bones screws from withdrawing from the fastener holes.
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US18/201,178 US20230293311A1 (en) | 2019-09-24 | 2023-05-23 | Standalone anterior lumber interbody spacer |
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US201962905384P | 2019-09-24 | 2019-09-24 | |
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US18/201,178 US20230293311A1 (en) | 2019-09-24 | 2023-05-23 | Standalone anterior lumber interbody spacer |
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US20230165690A1 (en) * | 2021-11-29 | 2023-06-01 | Spinal Elements, Inc. | Spinal implant device |
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US5458642A (en) * | 1994-01-18 | 1995-10-17 | Beer; John C. | Synthetic intervertebral disc |
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