US-12622790-B2 - Intervertebral fusion device with bone graft lumbar

Abstract

Described herein are intervertebral fusion devices and their methods of use. Also described herein are interbody device systems and the methods of using the same.

Inventors

• Jason Liauw
• Nicholas Hu

Assignees

• Bloom Biomedical, Inc.

Dates

Publication Date

20260512

Application Date

20210923

Claims (20)

1. 1 . A method of deploying an interbody implant into an intervertebral space of a patient, the method comprising: inserting an elongate tube proximate to the intervertebral space; inserting an inflatable balloon through the tube and into the intervertebral space; expanding the inflatable balloon to apply pressure against anatomy of a target disc space and to restore foraminal height; withdrawing the inflatable balloon from the intervertebral space; inserting the interbody implant through the tube into the intervertebral space; and filling the interbody implant with a load bearing filler material that comprises a plurality of particles configured to interlock to form a load bearing structure in the intervertebral space.
2. 2 . The method of claim 1 , wherein the trocar tube is attached to a fixation point affixed to bone.
3. 3 . The method of claim 2 , wherein the fixation point is a pedicle screw.
4. 4 . The method of claim 1 , wherein the tube is curved.
5. 5 . The method of claim 1 , wherein the tube is inserted laterally.
6. 6 . The method of claim 1 , wherein the tube is inserted posteriorly.
7. 7 . The method of claim 1 , wherein the inflatable balloon further comprises an outer sleeve.
8. 8 . The method of claim 7 , wherein the outer sleeve includes a rough surface to enable disc clearing and further expansion.
9. 9 . The method of claim 1 , wherein the load bearing filler material comprises cement, demineralized bone putty, epoxy, rigid particles, small metal particles, bone fragments, or a combination thereof.
10. 10 . The method of claim 1 , wherein the tube further comprises one or more sensors.
11. 11 . The method of claim 10 , wherein the one or more sensors is a pressure sensor, an impedance sensor, an ultrasonic sensor, or a combination thereof.
12. 12 . The method of claim 1 , wherein the interbody implant includes a closing mechanism.
13. 13 . The method of claim 12 , wherein the closing mechanism prevents extrusion of inner material.
14. 14 . The method of claim 13 , wherein the closing mechanism is a mechanical crimp, an electrostatic closure, a screw cap, a plug, or a combination thereof.
15. 15 . An interbody system for treating back pain and nerve pain of a patient, comprising: a tube configured to be inserted into an intervertebral space of the patient; a balloon configured to be inserted through the tube, wherein the balloon can be used to apply pressure against anatomy of a target disc space; an interbody implant configured to be inserted through the tube; and a load bearing filler material configured to be inserted into the interbody implant, wherein the load bearing filler material comprises a plurality of particles configured to interlock to form a load bearing structure in the intervertebral space.
16. 16 . The interbody system of claim 15 , wherein the interbody implant includes a braided structure, a weaved structure, a knit structure, a web-like structure, or a combination thereof.
17. 17 . The interbody system of claim 15 , wherein the load bearing filler material comprises cement, demineralized bone putty, epoxy, rigid particles, small metal particles, bone fragments, or a combination thereof.
18. 18 . The interbody system of claim 15 , wherein the balloon is configured to expand to restore foraminal height.
19. 19 . The interbody system of claim 15 , wherein the balloon is configured to distract the target disc space to create lordosis.
20. 20 . The interbody system of claim 15 , wherein the tube is curved.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application Ser. No. 63/082,255, filed Sep. 23, 2020, and U.S. Provisional Patent Application Ser. No. 63/172,945, filed Apr. 9, 2021, the entire disclosures of each of which are incorporated herein by reference. FIELD Described herein are intervertebral fusion devices and their methods of use. Also, described herein are interbody systems and the methods of using the same. BACKGROUND Degenerative joint disease in the spine usually involves the tandem degeneration of the intervertebral disc and the two posterior facet joints which act as a tripod to provide stabilization between the vertebrae of the spine. Degeneration of these joints are respectively termed disc degenerative disease (DDD) or disc arthropathy, and facet degenerative disease or facet arthropathy. The result of DDD is often thinning of the disc and a collapse of the disc height. The openings through which the spinal nerve roots go through when leaving the spinal column are called neural foramen, and the height of these foramina directly correspond to the height of the intervertebral disc. With collapse of the intervertebral disc height, the natural height of the neural foramina also collapses and as a result the exiting nerve root is compressed which can elicit nerve pain or radicular pain down the legs. Along with that, intervertebral disc height collapse can cause ligamentous laxity and bulging in the spine. These ligaments, namely the posterior longitudinal ligament (PLL) and ligamentum flavum, surround the cord and can bulge into the spinal canal as the disc height collapses. The result is compression of the whole spinal cord or thecal sac centrally in the spinal canal which can result in radicular pain down the legs in addition to weakness and fatigue in the legs, termed neurogenic claudication. The surgical treatment of back pain and sciatic pain include etiologies of pain which all stem from disc degenerative joint disease in the spine. These are as follows: The treatment of mechanical instability of the spine: Mechanical instability is a result of degeneration of both the intervertebral disc and/or the posterior facet joints. The mechanical instability causes painful arthritic pain or arthropathy. Much of spinal fixation is geared toward reducing mechanical instability and thereby reducing the movement of arthritic joints that get inflamed with movement. There are numerous methods to accomplishing spinal fixation, with both anterior column and posterior column fixation devices. The most pervasive spinal fixation method to this day involves posterior screws used in combination with interbody cages for anterior column support. The treatment of nerve root compression: As described above, nerve root compression can occur centrally around the spinal cord or thecal sac, or laterally around the exiting nerve root at the neural foramen. Pain from nerve root compression often travels according to a nerve root dermatomal distribution, causing radicular or sciatic pain. Spinal surgical decompression, aims to remove nerve pain by taking the compression off the nerve roots. This can be accomplished directly through removal of bone/ligament/disc compressing the nerve. It can also be accomplished indirectly by mechanically increasing the intervertebral height with an intervertebral interbody spacer or interlaminar spacer, thereby restoring neural foraminal height and reducing the bulging of the ligaments/disc that bulge into the spinal canal centrally. Restoring natural alignment of the spine: One of the newer paradigms in spinal fixation and fusion, is the restoration of sagittal balance with intervertebral spacers that restore natural lordotic curvature of the spine. The restoration of neutral spinal alignment enables the patient to walk or stand with good posture rather than leaning forward. This reduces the strain on the paraspinal musculature in the spine. Not restoring natural spinal alignment which performing spinal fixation often results in “flat back syndrome” where patients have chronic lower back pain due to muscular fatigue. Additionally inducing natural sagittal balance with the use of lordotic spacers has become a mainstay in preventing degeneration at the adjacent intervertebral spaces above and below a spinal fusion. Vertebral interbody spacers have become an important part of spinal fixation for reasons which relate to the fundamentals of treating back pain and nerve pain as follows: Intervertebral spacers improve treatment of mechanical instability: The insertion of an intervertebral spacer provides for more anterior support in fixation of the spine. This helps stabilize mechanical instability. Some intervertebral spacers with large footprints can be used as standalone fixation devices. They can also be used in conjunction with posterior spinal fixation, as they add anterior column supports allowing for more rigid stabilization whi