IP Library Granted Patent US 11,007,305
Granted Patent B1
US 11,007,305 · App. 15/485,221 · Granted May 18, 2021

Bone grafts with controlled release calcium

Inventors: Andrew J. Carter (Stow, MA); Nelson L. Scarborough (Andover, MA); Bradley E. Patt (Northridge, CA)
Assignee: THERACELL, INC.
A61L27/3608A61L27/18A61L27/34A61L27/446A61L27/46A61L27/54A61L27/58A61L2300/252A61L2300/414A61L2400/06A61L2430/02
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Quick Facts
Patent No.
US 11,007,305
App. No.
15/485,221
Granted
May 18, 2021
Kind
B1
Abstract

A bone graft for bone repair, the bone graft having controlled release bone mineral ions includes a resorbable polymer incorporated with a bone mineral ion donor to form a mineral-incorporated resorbable polymer, and demineralized bone matrix (DBM) mixed with the mineral-incorporated resorbable polymer.

Claims (25)

1. A demineralized bone matrix (DBM) fiber scaffold having controlled release calcium ions, the DBM fiber scaffold consisting of:

a resorbable polymer fiber incorporated with a calcium ion donor to form a calcium-incorporated resorbable polymer fiber, the calcium-incorporated resorbable polymer fiber having an outer polymer sheath;

demineralized bone matrix (DBM) fibers mixed with the calcium-incorporated resorbable polymer fiber;

magnesium and/or silicon; and

a phosphate-containing buffer;

wherein the calcium ion donor is calcium peroxide, calcium ascorbate, calcium sulfate, calcium phosphate, calcium carbonate, calcium chloride, and mixtures thereof; and

wherein the DBM fibers have a length from about 1 cm to about 30 cm, a width from about 0.05 mm to about 4 mm, and a thickness from about 0.05 mm to about 4 mm.

2. The DBM fiber scaffold of claim 1 , wherein the DBM fiber scaffold is in the form of a strip, a sphere, a cylinder, or a cone.

3. The DBM fiber scaffold of claim 1 , wherein the resorbable polymer fibers are selected from the group consisting of proteins, peptides, silk, collagen, polysaccharides, resorbable polyesters, including resorbable polyesters made from hydroxy acids, resorbable polyesters made from diols and diacids; polycarbonates; tyrosine polycarbonates, natural and synthetic polyamides, natural and synthetic polypeptides, natural and synthetic polyaminoacids, polyesteramides, poly(alkylene alkylates), polyethers, polyvinyl pyrrolidones, polyurethanes, polyetheresters, polyacetals, polycyanoacrylates, poly(oxyethylene)/poly(oxypropylene) copolymers, polyacetals, polyketals, polyphosphates, (phosphorous-containing) polymers, polyphosphoesters, polyalkylene oxalates, polyalkylene succinates, poly(maleic acids), biocompatible copolymers, hydrophilic or water soluble polymers, and combinations thereof.

4. The DBM fiber scaffold of claim 3 , wherein:

the collagen is selected from the group consisting of Types I, II, III, IV, V and combinations thereof;

the proteins or peptides comprise one or more of alanine, arginine, asparagine, aspartic acid, cysteine, glutamine, glutamic acid, glycine, histidine, isoleucine, lysine, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine and valine;

the polysaccharides are selected from alginate, amylose, carboxymethylcellulose, cellulose, chitin, chitosan, cyclodextrin, dextran, dextrin, gelatin, gellan, glucan, hemicellulose, hyaluronic acid, derivatized hyaluronic acid, oxidized cellulose, pectin, pullulan, sepharose, xanthan and xylan;

the resorbable polyesters are selected from the group consisting of poly(lactides), poly(glycolides), poly(lactide-co-glycolides), poly(lactic acid), poly(glycolic acid), poly(lactic acid-co-glycolic acid), poly(dioxanones), polycaprolactones and polyesters with one or more of the following monomeric units: glycolic, lactic; trimethylene carbonate, p-dioxanone, or ε-caprolactone;

the polyethers are selected from polyethylene glycol (PEG) or polyethylene oxide (PEO); and

the biocompatible copolymers are selected from the group consisting of polyethylene (PEG) or (PVP) with a block of a different biocompatible or biodegradable polymers selected from the group consisting of poly(lactide), poly(lactide-co-glycolide), polycaprolactone and combinations thereof.

5. A demineralized bone matrix (DBM) fiber scaffold having controlled release calcium ions, the DBM fiber scaffold consisting of:

a resorbable polymer fiber incorporated with a calcium ion donor to form a calcium-incorporated resorbable polymer fiber, the calcium-incorporated resorbable polymer fiber having an outer polymer sheath;

demineralized bone matrix (DBM) fibers mixed with the calcium-incorporated resorbable polymer fiber;

magnesium and/or silicon;

a phosphate-containing buffer; and

an excipient selected from the group consisting of glycerols, lecithins, polyoxamers, surfactants, and phospholipids;

wherein the calcium ion donor is calcium peroxide, calcium ascorbate, calcium sulfate, calcium phosphate, calcium carbonate, calcium chloride, and mixtures thereof; and

wherein the DBM fibers have a length from about 1 cm to about 30 cm, a width from about 0.05 mm to about 4 mm, and a thickness from about 0.05 mm to about 4 mm.

6. A method of repairing a bone or a bone defect in a subject in need thereof, comprising implanting the DBM fiber scaffold of claim 1 .

Assignments (8)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 26, 2025
From: THERACELL, LLC
To: ARTERIOCYTE MEDICAL SYSTEMS, INC.
Reel/Frame 072388/0197 →
SECURITY INTEREST Recorded Sep 18, 2025
From: ISTO TECHNOLOGIES II, LLC; ADVANCED BIOLOGICS LLC,; ARTERIOCYTE MEDICAL SYSTEMS, INC.; THERACELL, LLC
To: GOLUB CAPITAL MARKETS LLC
Reel/Frame 072300/0216 →
RELEASE OF SECURITY INTEREST Recorded Sep 16, 2025
From: BARINGS FINANCE LLC, AS COLLATERAL AGENT
To: ARTERIOCYTE MEDICAL SYSTEMS, INC.; ISTO TECHNOLOGIES II, LLC; THERACELL, LLC; ADVANCED BIOLOGICS, LLC; BIOLOGICA TECHNOLOGIES, LLC
Reel/Frame 072274/0408 →
RELEASE OF SECURITY INTEREST Recorded Oct 18, 2023
From: TWIN BROOK CAPITAL PARTNERS, LLC
To: ISTO TECHNOLOGIES II, LLC
Reel/Frame 065269/0604 →
SECURITY INTEREST Recorded Oct 18, 2023
From: ARTERIOCYTE MEDICAL SYSTEMS, INC.; ISTO TECHNOLOGIES II, LLC; THERACELL, LLC; ADVANCED BIOLOGICS, LLC; BIOLOGICA TECHNOLOGIES, LLC
To: BARINGS FINANCE LLC, AS COLLATERAL AGENT
Reel/Frame 065271/0059 →
CHANGE OF NAME Recorded Oct 11, 2023
From: THERACELL, INC.
To: THERACELL, LLC
Reel/Frame 065219/0102 →
SECURITY INTEREST Recorded Apr 4, 2022
From: THERACELL, INC.
To: TWIN BROOK CAPITAL PARTNERS, LLC, AS AGENT
Reel/Frame 059486/0202 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 8, 2018
From: CARTER, ANDREW J.; SCARBOROUGH, NELSON L.; PATT, BRADLEY E.
To: THERACELL, INC.
Reel/Frame 047457/0141 →
Continuity (1)
Provisional Application 62321019 · Apr 11, 2016