Composition for the treatment of intervertebral disc pain, and method of manufacturing and using the same

Abstract

This specification describes compositions for treating discogenic pain. In various embodiments, the compositions comprise PMMA microparticles, Pluronic® surfactant, PBS, and a radioactive marker. In some embodiments, the PMMA microparticles have a particle size distribution of 25 to 125 micrometers and are non-linearly crosslinked. The compositions can be stored at cooling temperatures and, after injection, can be heated to transition to a gel state. Furthermore, the compositions may comprise about 50% PMMA microparticles, about 10% Pluronic®, about 30% PBS, and about 10% a radioactive marker.

Claims

1. Approximately 30-60% poly(methyl methacrylate) (PMMA) fine particles; Approximately 8-25% Pluronic® surfactant; Approximately 19-49% phosphate-buffered saline (PBS); and Approximately 8-14% of radiation markers, A composition of a substance comprising the PMMA fine particles having a particle size distribution of approximately 25 to 125 micrometers and being nonlinearly crosslinked.

2. moreover: Approximately 35-55% PMMA; and Approximately 8-12% Pluronic® surfactant, The composition according to claim 1, comprising:

3. The composition according to claim 1, wherein the PMMA fine particles have a particle size distribution of approximately 53 to 106 micrometers and are nonlinearly crosslinked.

4. The composition according to claim 1, further comprising approximately 2-3% carboxymethylcellulose.

5. The composition according to claim 1, wherein the composition is a liquid at a temperature of about 3 to 8°C and a gel at body temperature.

6. The composition according to claim 5, wherein the gelation time from approximately 3 to 8°C to body temperature is approximately 30 seconds to 20 minutes.

7. The composition according to claim 6, wherein the gelation time from approximately 3 to 8°C to body temperature is approximately 2 to 15 minutes.

8. The composition according to claim 7, wherein the gelation time from approximately 3 to 8°C to body temperature is approximately 3 to 5 minutes.

9. The composition according to claim 6, wherein the gelation time from approximately 3 to 8°C to body temperature is approximately 30 seconds to 5 minutes.

10. The composition according to claim 1, wherein the composition has a viscosity of about 68,400 cP to about 72,000 cP before injection.

11. Approximately 30-60% poly(methyl methacrylate) (PMMA) fine particles; Hydrogels with a concentration of approximately 8-25%; Approximately 19-49% phosphate-buffered saline (PBS); and Approximately 8-14% of radiation markers, A composition of a substance comprising the PMMA fine particles having a particle size distribution of approximately 25 to 125 micrometers and being nonlinearly crosslinked.

12. The composition according to claim 11, wherein the hydrogel comprises a Pluronic® surfactant.

13. moreover, Approximately 35-55% PMMA; and Approximately 8-12% Pluronic® surfactant, The composition according to claim 12, comprising:

14. The composition according to claim 13, wherein the PMMA fine particles have a particle size distribution of approximately 53 to 106 micrometers and are nonlinearly crosslinked.

15. A method for producing a composition of a substance comprising approximately 8-25% Pluronic® surfactant, approximately 19-49% PBS, approximately 8-14% radiomarker, and approximately 30-60% PMMA fine particles, wherein the method is A step of mixing PBS, Pluronic® surfactant, and a radioactive marker to form a carrier solution; A step of mixing multiple PMMA fine particles having a particle size distribution of approximately 25 to 125 micrometers and being nonlinearly crosslinked into the carrier solution; A step of cooling the composition to approximately 3 to 8°C; A step of adding the composition to a vial; A step of sealing the vial; A step of sterilizing the vial; and A step of storing the sterilized vial at approximately 3 to 8°C, Methods that include...

16. The method according to claim 15, wherein the mixing of the PMMA fine particles is performed using a mixer at room temperature at approximately 2000 rpm for approximately 2 minutes.

17. The method according to claim 15, wherein the mixing of the PMMA fine particles into the carrier solution is performed at approximately 20°C.

18. The method according to claim 15, wherein the radiation marker comprises a radiation-impermeable dye.

19. A method for treating intervertebral disc-derived pain according to claim 15, The first injection involves injecting the aforementioned composition into the nucleus pulposus of the intervertebral disc, and the method further involves... A step of determining the patient's pain level after the first injection; and If it is determined that the patient's pain level exceeds a predetermined threshold, the therapeutic solution is injected into the nucleus pulposus of the spinal intervertebral disc as a second injection. Methods that include...

20. The following steps: A step of storing a vial having a cap at approximately 3 to 8°C, wherein the vial contains a composition, and the composition is: Approximately 30-60% poly(methyl methacrylate) (PMMA) fine particles; Hydrogels with a concentration of approximately 8-25%; Approximately 19-49% phosphate-buffered saline (PBS); and It contains approximately 8-14% radiation markers. The process here comprises the PMMA fine particles having a particle size distribution of about 25 to 125 micrometers and being nonlinearly crosslinked; The process of removing the vial from its storage state; A step of mixing the aforementioned composition; The step of removing the cap from the vial; The process of attaching a cannula to a syringe having a plunger; The step of inserting the cannula into the vial; A step of drawing the composition from the vial into the syringe; A step of attaching a spinal needle including a stopcock to the syringe, wherein the stopcock is in the open position when it is attached to the syringe; A step of removing air trapped in the spinal needle by discharging a small amount of composition from the syringe through the spinal needle; The step of inserting the spinal needle into the patient's intervertebral disc; A step of injecting the aforementioned composition into the patient's intervertebral disc; After the injection of the composition is complete, move the stopcock to the closed position; The step of removing the syringe from the stopcock; A step of allowing the composition to transition from a liquid to a gel as its temperature rises; and The process of removing the spinal needle from the patient after the composition has gelled within the patient's intervertebral disc, Methods for treating intervertebral disc-related pain, including [specific example].

21. The method according to claim 20, wherein the hydrogel comprises a Pluronic® surfactant.

22. The method according to claim 21, wherein the composition further comprises about 35-55% PMMA and about 8-12% Pluronic® surfactant.

23. The method according to claim 20, wherein the PMMA fine particles have a particle size distribution of approximately 53 to 106 micrometers and are nonlinearly crosslinked.

24. The method according to claim 20, wherein the composition further comprises about 2-3% carboxymethylcellulose.

25. The method according to claim 20, wherein the composition is a liquid at a temperature of about 3 to 8°C and a gel at body temperature.

26. The method according to claim 20, wherein the gelation time during a temperature change from approximately 3 to 8°C to body temperature is approximately 30 seconds to 20 minutes.

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