Drug delivery for intervertebral disc pain management
Inventors
Assignees
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Publication Number
US-12472141-B2
Publication Date
2025-11-18
Expiration Date
Abstract
Biomaterials, implants, methods of making the biomaterial and implants, methods of providing pain relief by administering the biomaterial or implant to a patient, and kits that include such biomaterials, implants, or components thereof. The biomaterials may include microparticles including one or more active pharmaceutical agents, such as anesthetics, antibiotics, and corticosteroids, which help to provide pain relief over an extended period of time. The biomaterials may be applied directly to the intervertebral disc or in the disc space to provide direct therapy for the management of disc pain.
Core Innovation
The invention relates to an intervertebral implant and an intervertebral spacer system configured to be implanted in an intervertebral disc space. The implant comprises an interbody fusion spacer with biodegradable microparticles embedded in a carrier, and each biodegradable microparticle includes an innermost layer, an intermediate layer, and an outermost layer that encapsulate one another, where the innermost layer and the intermediate layer comprise one or more of an antibiotic or an anti-inflammatory, and the outermost layer comprises an anesthetic.
The layered biodegradable microparticles are used to facilitate intervertebral fusion until the implant is fully resorbed. Pain relief is addressed by including first size microparticles configured to provide extended pain relief and second size microparticles configured to resorb and elute faster providing immediate pain relief, and the plurality of biodegradable microparticles are configured based on desired pain relief.
The microparticle design uses two size populations with different diameters for the first size microparticles and the second size microparticles. In the spacer system, the biomaterial composition containing the plurality of biodegradable microparticles is placed in a hollow interior chamber of the implant and/or on one or more surfaces as a surface coating, to incorporate the layered antibiotic/anti-inflammatory and anesthetic microparticle composition into the implanted device.
Claims Coverage
The patent text provided includes three independent claims. Across these claims, the common inventive structure is layered biodegradable microparticles embedded in or associated with an intervertebral implant, including first and second size microparticles with different diameters to support extended and immediate pain relief.
Layered biodegradable microparticles in intervertebral implant for fusion and pain relief
An interbody fusion spacer comprising a plurality of biodegradable microparticles embedded in a carrier, each biodegradable microparticle comprising an innermost layer comprising one or more of an antibiotic or an anti-inflammatory, an intermediate layer encapsulating the innermost layer and comprising one or more of an antibiotic or an anti-inflammatory, and an outermost layer encapsulating the intermediate layer and comprising an anesthetic, wherein the intervertebral implant facilitates intervertebral fusion until the implant is fully resorbed.
Two size microparticles configured for extended versus immediate pain relief
The plurality of biodegradable microparticles include first size microparticles configured to provide extended pain relief and second size microparticles configured to resorb and elute faster providing immediate pain relief, wherein the plurality of biodegradable microparticles are configured based on desired pain relief.
Different diameters for extended and immediate pain relief microparticles
The first size microparticles and the second size microparticles have different diameters.
Hollow interior chamber and/or surface coating location for biomaterial composition
An intervertebral spacer system comprising an intervertebral implant with a hollow interior chamber and a biomaterial composition placed in the hollow interior chamber, on one or more surfaces as a surface coating, or both, wherein the biomaterial composition comprises a plurality of biodegradable microparticles having the innermost, intermediate, and outermost layers including antibiotic/anti-inflammatory in the inner layers and an anesthetic in the outermost layer.
Method positioning of implant to alleviate disc pain using layered microparticles
A method of alleviating disc pain comprising positioning an intervertebral implant in a disc space between adjacent vertebrae, wherein the intervertebral implant comprises a body having a front end, a rear end, an upper surface configured to engage an inferior endplate of a superior vertebral body, and a lower surface configured to engage a superior endplate of an inferior vertebral body, and wherein the body comprises a plurality of biodegradable microparticles embedded in a carrier, each biodegradable microparticle comprising an innermost layer with one or more of an antibiotic or an anti-inflammatory, an intermediate layer encapsulating the innermost layer with one or more of an antibiotic or an anti-inflammatory, and an outermost layer encapsulating the intermediate layer comprising an anesthetic.
Taken together, the independent claims require an intervertebral implant or spacer system that incorporates biodegradable microparticles with an innermost and intermediate antibiotic/anti-inflammatory layer structure and an outermost anesthetic layer, and uses two size populations of microparticles with different diameters that are configured based on desired pain relief to provide extended pain relief and resorb and elute faster to provide immediate pain relief.
Stated Advantages
Facilitates intervertebral fusion until the implant is fully resorbed.
Provides extended pain relief via first size microparticles.
Provides immediate pain relief via second size microparticles configured to resorb and elute faster.
Provides pain relief that is configured based on desired pain relief.
Documented Applications
Alleviating disc pain in a subject by positioning an intervertebral implant in a disc space between adjacent vertebrae.
Implantation in an intervertebral disc space using an interbody fusion spacer or intervertebral spacer system incorporating layered biodegradable microparticles for disc pain management and intervertebral fusion until full resorption.
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