SPINAL FUSION IMPLANT AND RELATED METHODS

• US 20190314164A1
• Filed: 04/16/2019
• Published: 10/17/2019
• Est. Priority Date: 04/16/2018
• Status: Active Application

• Current Assignee: Brahm Holdings, LLC
• Original Assignee: Brahm Holdings, LLC
• Inventors: BRAHM, Timothy R., Curlee, Patrick
• Application Number:
  US16/385,241
• Publication Number:
  US 20190314164A1
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/7062 Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs rib fixation devices A61B17/8076; Tools for such devices
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/4405 for apophyseal or facet joints, i.e. between adjacent spinous or transverse processes devices implanted between spinous or transverse processes A61B17/7062
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30059 differing in bone mineralization, e.g. made from both mineralized and demineralized adjacent parts
• CPC Class Codes: A61F 2002/30517 using a locking plate
• CPC Class Codes: A61F 2002/30579 with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2310/00293 containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• CPC Class Codes: A61L 2430/38 for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 2430/40 Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking
• CPC Class Codes: A61L 27/3608 Bone, e.g. demineralised bone matrix [DBM], bone powder
• CPC Class Codes: A61L 27/365 Bones
• CPC Class Codes: A61L 27/3683 : subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: A61L 27/38 : containing added animal cells organs or tissue containing native cells A61L27/36
• CPC Class Codes: A61L 27/54 : Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/56 : Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 27/58 : Materials at least partially resorbable by the body

Abstract

A spinal graft is provided. Methods for stabilizing the spine and methods for delivering at least one flowable composition to a spinal region are also provided.

Claims

1. A graft comprising

a shell having a first side and a second opposing side,

wherein the first side comprises cortical bone,

wherein the second, opposing side comprises compressed cancellous bone,

wherein the graft is shaped to be placed between facets and pedicals in a spine,

wherein the compressed cancellous bone is infused with and delivers at least one flowable composition to a spinal region.

2. The graft of claim 1, wherein the flowable composition includes at least one liquid component selected from the group consisting of Minimum Essential Medium, Dulbecco'"'"'s Modified Eagle'"'"'s Medium, Plasma Lyte-A, human albumin 25% solution, calcium-rich water, alkaline ionized water, acidic ionized water, pharmaceutical grade water, neutral pH saline, blood, PRP, and a combination thereof.

3. The graft of claim 2, wherein the flowable composition includes a flowable birth tissue material composition.

6. The graft of claim 1, further comprising one or more natural or recombinant bone morphogenetic proteins (BMPs).

7. The graft of claim 6, wherein the bone morphogenetic protein is BMP-2, BMP-7 or a combination thereof.

8. The graft of claim 1, further comprising one or more synthetic-based bone graft extenders.

9. The graft of claim 8, wherein the one or more synthetic-based bone graft extenders is calcium phosphate, tricalcium phosphate, phosphate, calcium sulfate, bioactive glass, or a combination thereof.

10. The graft of claim 1, further comprising one or more bioactive agents.

11. The graft of claim 1, further comprising one or more synthetic polymers.

12. A method of stabilizing a vertebral region of a spine comprising

providing the graft of claim 1,

applying the graft to a vertebral region of the spine such that the second, opposing side is placed into a spinal gutter.

13. The method of claim 12, further comprising the step of securing the graft to the vertebral region with at least one screw, rod, plate, or a combination thereof.

14. A method for delivering at least one flowable composition to a spinal region comprising

introducing at least one flowable composition to the second, opposing side of the graft of claim 1;

and

introducing the graft to the spinal region of a patient in need treatment,

wherein at least one flowable composition is delivered in a time release manner.

15. The graft of claim 14, wherein the flowable composition includes at least one liquid component selected from the group consisting of Minimum Essential Medium, Dulbecco'"'"'s Modified Eagle'"'"'s Medium, Plasma Lyte-A, human albumin 25% solution, calcium-rich water, alkaline ionized water, acidic ionized water, pharmaceutical grade water, neutral pH saline, blood, PRP, and a combination thereof.

16. The graft of claim 14, wherein the flowable composition includes a flowable birth tissue material composition.

17. A kit comprising

a graft as provided in claim 1,

optionally, at least one screw, rod, or combination thereof for securing the graft to the spine;

and

instructions for use thereof.

4. The graft of claim 4, wherein the flowable birth tissue composition comprises one or more components of the placental organ.

5. The graft of claim 4, wherein the one or more of the components of the placental organ is selected from the group consisting of umbilical cord, umbilical cord blood, chorionic membrane, amniotic membrane, amnion membrane, Wharton'"'"'s jelly, amniotic fluid, and other placental gelatins, cells, and extracellular material.