Spinal disk regenerative composition and method of manufacture and use

Patent metadata

Field	Value
Publication number	US-2016015753-A1
Application number	US-201414334318-A
Country	US
Kind code	A1
Filing date	Jul 17, 2014
Priority date	Jul 17, 2014
Publication date	Jan 21, 2016
Grant date	—

Abstract

The present invention provides a novel way to replenish the disc using retooled disc compositions to repair degenerative discs. There is no better source of proteoglycans than the actual disc material ( 6 ) itself. To this end, there has been developed a technique to remove the nucleus pulposus and retool the morphology of the nucleus pulposus to create a powder material ( 10 ) that is dry and can be stored at room temperature for long periods of time. This powder ( 10 ) can then be reconstituted with a variety of fluids, the most suitable being normal saline or lactated ringers to form a flowable mixture ( 20 ).

First claim

1 . An aqueous spinal disc regenerative composition suitable for injection is prepared from a micronized material of dried nucleus pulposus wherein the micronized material has particles sized less than 400 microns, the composition when prepared for injection has the micronized material of dried nucleus pulposus rehydrated using one or more of normal saline, lactated ringers solution, blood, platelet rich plasma or combinations thereof to create the aqueous spinal disc regenerative composition to form a flowable mixture of a viscosity high enough to avoid a leakage through an injection portal or pre-existing fissures in a damaged disc to be treated.

2 . (canceled)

3 . The aqueous spinal disc regenerative composition of claim 1 wherein the micronized material is formed as a powder.

4 . The aqueous spinal disc regenerative composition of claim 3 wherein the powder is dried either hypothermically in a cold desiccator or in a standard commercial freeze dryer.

5 . The aqueous spinal disc regenerative composition of claim 1 wherein a quantity of nucleus pulposus is taken from cadaver vertebrae to make the micronized material of dried nucleus pulposus.

6 . The aqueous spinal disc regenerative composition of claim 5 wherein the cadaver vertebrae are human vertebrae.

7 . The aqueous spinal disc regenerative composition of claim 4 wherein the micronized material of dried nucleus pulposus has dehydrated proteoglycan molecules.

8 . The aqueous spinal disc regenerative composition of claim 4 wherein the micronized material of dried nucleus pulposus has been dried to less than 5% moisture content prior to being rehydrated into an aqueous flowable mixture suitable for injection to be stored or maintained in a syringe prior to administration into a damaged disc to be treated.

9 . The aqueous spinal disc regenerative composition of claim 8 wherein the micronized material when rehydrated has a high viscosity.

10 . The aqueous spinal disc regenerative composition of claim 9 wherein the aqueous composition exhibits a viscosity which is flowable as injectable through a small bore cannula.

11 . A storage and delivery device for an aqueous spinal disc regenerative composition comprises:
a syringe or other injectable device for insertion into a damaged disc to be treated; an aqueous spinal disc regenerative composition suitable for injection which consists essentially of a micronized material of dried nucleus pulposus; wherein the dried micronized material has been dried to less than 5% moisture content prior to being rehydrated into an aqueous mixture suitable for injection and stored or maintained in the syringe and wherein the micronized material when rehydrated has a high viscosity and wherein the aqueous composition exhibits a viscosity at which the rehydrated micronized material is flowable as injectable through a small bore cannula.

12 . The aqueous spinal disc regenerative composition of claim 4 wherein the aqueous composition is mixed with one or more of the following, including stem cells that are derived from marrow, fat, blood, or interspinous ligaments, or other sources of stem cells, micronized amnion, platelet rich plasma, a variety of growth factors that can be encapsulated into pharmacologically active microspheres otherwise known as PAMS, genetically altered cells that produce large amounts of glycosaminoglycans, collagen Type 1 or glucose or combinations thereof.

13 . A method of manufacturing a spinal disc regenerative composition comprises the steps of:
aseptic recovery of cadaveric spine segments from T9 to L5; removal of the discs by cutting between the cancellous bone and vertebral endplate junction; removing the normal nucleus pulposus; freeze drying the nucleus pulposus from multiple disc segments; placing the freeze dried material into a cryomill; and placing the micronized disc material into a sterile container for later use

14 . A treatment method for damaged spinal disc regeneration comprises the steps of:
rehydrating the micronized material into a flowable mixture; placing the material in a container for injection or a syringe either prior to or during or after the step of hydration; injecting the hydrated material through a cannula into the disc space to be regenerated.

15 . The treatment method of claim 14 wherein the method further comprises the step of:
sealing cracks in the damaged disc with fibrin glue or other blood product to prevent leakage of the hydrated material.

16 . The treatment method of claim 14 wherein the cannula is sized between 2 mm or less.

17 . The treatment method of claim 16 wherein the injected hydrated material is later sealed with fibrin glue or another blood product.

18 . The treatment method of claim 14 wherein the treated disc regenerates or heals as evidenced by an increase in proteoglycans molecules.

19 . The treatment method of claim 14 wherein the dried powder material is rehydrated using one of normal saline, lactated ringers solution, blood, platelet rich plasma or a combination thereof to form a rehydrated mixture.

20 . The treatment method of claim 19 wherein the rehydrated mixture is mixed with one or more of stem cells that are derived from marrow, fat, blood or interspinous ligaments, micronized amnion, plated with plasma, a variety of growth factors that can be encapsulated into pharmacologically active microspheres otherwise known as PAMS, genetically altered cells that produce large amounts of glycosaminoglycans, collagen Type 1 or glucose to form the flowable mixture.

Assignees

• Temple Harry Thomas
• Vivex Biomedical Inc

Inventors

• Temple Harry Thomas

Classifications

• A61B17/7061

  for stabilising vertebrae or discs by improving the condition of their tissues, e.g. using implanted medication or fluid exchange (intraosseous injection devices A61B17/3472) · CPC title

• A61B17/8805

  for introducing fluid filler into bone or extracting it (A61B17/7097, A61B17/8833 take precedence) · CPC title

• A61L27/54

  Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)} · CPC title

• A61L27/3612

  Cartilage, synovial fluid · CPC title

• A61K9/0019

  Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00) · CPC title