# US 2019/0314550 A1 · Bone substitute composition and related methods > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2019/0314550 A1 - Document ID: US20190314550A1 - Status: Published application - Kind: A1 - Application number: 16/385,240 - Filed: 2019-04-16 - Published: 2019-10-17 - Earliest claimed: 2018-04-16 - Assignees: Brahm Holdings, LLC - Applicants: Brahm Holdings, LLC - Inventors: Timothy R. BRAHM - Web page: https://patentgrep.com/patent/US20190314550A1 ## CPC - A61L 27/3608: {Bone, e.g. demineralised bone matrix [DBM], bone powder} - A61L 27/365: {Bones} - A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)} - A61L 2300/252: Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines - A61L 2300/414: Growth factors - A61L 2300/602: Type of release, e.g. controlled, sustained, slow - A61L 2430/02: for reconstruction of bones; weight-bearing implants - A61L 2430/38: for reconstruction of the spine, vertebrae or intervertebral discs - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) ## Abstract A substitute composition is provided that includes at least one cadaveric material and at least one liquid component which, upon introduction to the cadaveric material, causes the cadaveric material to expand and become flowable. Methods for stabilizing a vertebral space are also provided. ## Claims ### Claim 1 A bone substitute composition comprising at least one cadaveric material selected from the group consisting of cancellous bone, demineralized cancellous bone, fresh allograft, frozen allograft freeze dried bone allograft, demineralized freeze dried bone allograft, cortical cancellous bone, or a combination thereof; and at least one liquid component which, upon introduction to the cadaveric material, causes the cadaveric material to expand and become flowable. ### Claim 2 (depends on 1) The bone substitute composition of claim 1, wherein the at least one liquid component includes one or more vitamins, nutrients, inflammatory inhibitors, antibiotics, cytokines, minerals, growth factors, hyaluronic acids, cellular attractants, scaffolding reagents, antibiotics, chemotherapeutic agents, antigens, antibodies, enzymes, NSAIDs, muscle relaxants, 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, platelet rich plasma, a flowable birth tissue composition, and any combination thereof. ### Claim 3 (depends on 1) The bone substitute composition of claim 1, further comprising one or more natural or recombinant bone morphogenetic proteins (BMPs). ### Claim 4 (depends on 3) The bone substitute composition of claim 3, wherein the bone morphogenetic protein is BMP-2, BMP-7 or a combination thereof. ### Claim 5 (depends on 1) The bone substitute composition of claim 1, further comprising one or more synthetic-based bone graft extenders. ### Claim 6 (depends on 1) The bone substitute composition of claim 1, wherein the bone substitute composition is formulated as a flowable putty to fill a bone void and expandable upon introduction of the at least one liquid component. ### Claim 7 (depends on 1) The bone substitute composition of claim 1, wherein the bone substitute composition is shaped as a wedge, wafer, wafer implant gasket or custom sized and shaped to fill a particular vertebral space. ### Claim 8 (depends on 1) A method of stabilizing a vertebral space comprising providing a bone substitute composition as provided in claim 1; and introducing the bone substitute composition to the vertebral space, whereby the bone substitute composition expands, fills the vertebral space, and delivers the liquid component to the space. ### Claim 9 (depends on 8) The method of claim 8, wherein the liquid component includes one or more vitamins, nutrients, inflammatory inhibitors, antibiotics, cytokines, minerals, growth factors, hyaluronic acids, cellular attractants, scaffolding reagents, antibiotics, chemotherapeutic agents, antigens, antibodies, enzymes, NSAIDs, muscle relaxants, 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, platelet rich plasma, a flowable birth tissue composition, and any combination thereof. ### Claim 10 (depends on 8) The method of claim 8, wherein the vertebral space is present anywhere in a mammalian skeletal system. ### Claim 11 (depends on 8) The method of claim 8, wherein the vertebral space is between an implant and a bone. ### Claim 12 (depends on 8) The method of claim 8, wherein the vertebral space is between or around one or more bones. ### Claim 13 (depends on 8) The method of claim 8, wherein the vertebral space is in the spine, foot, knee, hip or shoulder. ### Claim 14 (depends on 8) The method of claim 8, wherein the bone substitute composition is shaped as a wedge, wafer, wafer implant gasket or custom sized to fill a particular vertebral space. ### Claim 15 (depends on 14) The method of claim 14, wherein the wafer is between 0.1 cm and 10 cm thick. ### Claim 16 (depends on 8) The method of claim 8, further comprising the step of hydrating the at least one cadaveric material with the at least one liquid component prior to introducing the bone substitute composition. ### Claim 17 A method for delivering at least one liquid component to an area of bone in need of treatment comprising introducing at least one liquid component to at least one material selected from the group consisting of cancellous bone, demineralized cancellous bone, fresh allograft, frozen allograft freeze dried bone allograft, demineralized freeze dried bone allograft, cortical cancellous bone, and a combination thereof to form a bone substitute composition; and introducing the bone substitute composition to an area of bone in need treatment, wherein the at least one liquid component is delivered in a time release manner. ### Claim 18 (depends on 17) The method of claim 17, wherein the at least one liquid component includes one or more vitamins, nutrients, inflammatory inhibitors, antibiotics, cytokines, minerals, growth factors, hyaluronic acids, cellular attractants, scaffolding reagents, antibiotics, chemotherapeutic agents, antigens, antibodies, enzymes, NSAIDs, muscle relaxants, 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, platelet rich plasma, a flowable birth tissue composition, and any combination thereof. ### Claim 19 (depends on 17) The method of claim 17, wherein the liquid component aids in fusing the spinal region. ### Claim 20 (depends on 1) A kit for stabilizing or treating an area in need of treatment comprising a bone substitute composition as provided in claim 1; optionally, at least one screw, rod, or combination thereof for securing the bone substitute composition to the spine; and instructions for use thereof.