IP Library Granted Patent US 11,039,943
Granted Patent B2
US 11,039,943 · App. 14/207,336 · Granted Jun 22, 2021

Bioabsorbable biomedical implants

Inventors: James B. McClain (Raleigh, NC); Charles Douglas Taylor (Franklinton, NC)
Assignee: Micell Technologies, Inc.
A61F2/86A61L31/06A61L31/10A61L31/16A61F2210/0004A61F2250/0035A61F2250/0067A61L31/148A61L2300/416
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Quick Facts
Patent No.
US 11,039,943
App. No.
14/207,336
Granted
Jun 22, 2021
Kind
B2
Abstract

A bioabsorbable biomedical implant is disclosed. The implant includes a tubular scaffold comprising a plurality of interconnected polymer struts. The interconnected polymer struts defines a plurality of deformable cells. The polymer struts have an average thickness of no more than 120 μm. Methods for making the bioabsorbable biomedical implant, including the methods for making the polymer materials for the tubular scaffold, are also disclosed.

Claims (11)

1. A biomedical implant, comprising:

a tubular scaffold comprising a plurality of interconnected bioabsorbable polymer struts, the interconnected polymer struts defining a plurality of deformable cells, said polymer struts including polymer chains that are longitudinally aligned along the axis of said polymer struts, and wherein the tubular scaffold has an average axial elastic modulus along an axis of the tubular scaffold and an average circumferential elastic modulus orthogonally surrounding the axis of the tubular scaffold, the average circumferential elastic modulus being greater than the average axial elastic modulus; and

a pharmaceutical agent admixed with the bioabsorbable polymer struts of the implant in a manner which does not affect the structural and morphological integrity of the pharmaceutical agent, the pharmaceutical agent being a macrolide immunosuppressant drug in crystalline form,

wherein the polymer struts have an average thickness of no more than 120 μm and wherein the pharmaceutical agent is dispersed within and evenly distributed throughout the volume of the polymer struts such that the entirety of the implant is bioabsorbable.

2. The biomedical implant of claim 1 , wherein the tubular scaffold maintains at least 50% of its nominal luminal cross sectional area under a pressure load of 50 mmHg.

3. The biomedical implant of claim 1 , wherein at least 80% of the polymer struts are bioabsorbed within 2 years after deployment in vivo.

4. The biomedical implant of claim 1 , wherein the polymer struts comprises a polymer material selected from the group consisting of polycarboxylic acids, cellulosic polymers, proteins, polypeptides, polyvinylpyrrolidone, maleic anhydride polymers, polyamides, polyvinyl alcohols, polyethylene oxides, glycosaminoglycans, polysaccharides, polyesters, aliphatic polyesters, polyurethanes, polystyrenes, copolymers, silicones, silicone containing polymers, polyalkyl siloxanes, polyorthoesters, polyanhydrides, copolymers of vinyl monomers, polycarbonates, polyethylenes, polypropytenes, polylactic acids, polylactides, polyglycolic acids, polyglycolides, polylactide-co-glycolides, polycaprolactones, poly(e-caprolactone)s, polyhydroxybutyrate valerates, polyacrylamides, polyethers, polyurethane dispersions, polyacrylates, acrylic latex dispersions, polyacrylic acid, polyalkyl methacrylates, polyalkylene-co-vinyl acetates, polyalkylenes, aliphatic polycarbonates polyhydroxyalkanoates, polytetrahalooalkylenes, poly(phosphasones), polytetrahalooalkylenes, poly(phosphasones), and mixtures, combinations, and copolymers thereof.

5. The biomedical implant of claim 1 , wherein the macrolide immunosuppressant is selected from the group consisting of rapamycin, 40-O-(2-Hydroxyethyl)rapamycin (everolimus), 40-O-Benzyl-rapamycin, 40-O-(4′-Hydroxymethyl)benzyl-rapamycin, 40-O-[4′-(1,2-Dihydroxyethyl)]benzyl-rapamycin, 40-O-Allyl-rapamycin, 40-O-[3′-(2,2-Dimethyl-1,3-dioxolan-4(S)-yl)-prop-2′-en-1′-yl]-rapamycin, (2′:E,4′S)-40-O-(4′,5′-Dihydroxypent-2′-en-1′-yl)-rapamycin, 40-O-(2-Hydroxy)ethoxycar-bonylmethyl-rapamycin, 40-O-(3-Hydroxy)propyl-rapamycin, 40-O-(6-Hydroxy)hexyl-rapamycin, 40-O-[2-(2-Hydroxy)ethoxy]ethyl-rapamycin, 40-O-[(3S)-2,2-Dimethyldioxolan-3-yl]methyl-rapamycin, 40-O-[(2S)-2,3-Dihydroxyprop-1-yl]-rapamycin, 40-O-(2-Acetoxy)ethyl-rapamycin, 40-O-(2-Nicotinoyloxy)ethyl-rapamycin, 40-O-[2-(N-Morpholino)acetoxy]ethyl-rapamycin, 40-O-(2-N-Imidazolylacetoxy)ethyl-rapamycin, 40-O-[2-(N-Methyl-N′-piperazinyl)acetoxy]ethyl-rapamycin, 39-O-Desmethyl-39,40-O,O-ethylene-rapamycin, (26R)-26-Dihydro-40-O-(2-hydroxy)ethyl-rapamycin, 28-O-Methyl-rapamycin, 40-O-(2-Aminoethyl)-rapamycin, 40-O-(2-Acetaminoethyl)-rapamycin, 40-O-(2-Nicotinamidoethyl)-rapamycin, 40-O-(2-(N-Methyl-imidazo-2′-ylcarbethoxamido)ethyl)-rapamycin, 40-O-(2-Ethoxycarbonylaminoethyl)-rapamycin, 40-O-(2-Tolylsulfonamidoethyl)-rapamycin, 40-O-[2-(4′,5′-Dicarboethoxy-1′,2′,3′-triazol-1′-yl)-ethyl]-rapamycin, 42-Epi-(tetrazolyl)rapamycin (tacrolimus), and 42-[3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate]rapamycin.

6. The biomedical implant of claim 1 , wherein the pharmaceutical agent is rapamycin.

7. The biomedical implant of claim 1 , wherein at least a portion of the tubular scaffold is covered with a coating comprising a second pharmaceutical agent.

8. The biomedical implant of claim 1 , wherein the tubular scaffold has an average axial elastic modulus along an axis of the tubular scaffold and an average circumferential elastic modulus orthogonally surrounding the axis of the tubular scaffold, the average circumferential elastic modulus being greater than the average axial elastic modulus.

Assignments (6)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 7, 2023
From: MT ACQUISITION HOLDINGS LLC
To: MICELL MEDTECH INC.
Reel/Frame 064829/0447 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 23, 2022
From: MICELL SPV EQUITY LLC; MICELL SPV I LLC
To: MT ACQUISITION HOLDINGS LLC
Reel/Frame 059075/0462 →
NUNC PRO TUNC ASSIGNMENT Recorded Oct 22, 2021
From: MICELL TECHNOLOGIES, INC.
To: MICELL SPV EQUITY LLC; MICELL SPV I LLC
Reel/Frame 057876/0799 →
SECURITY INTEREST Recorded Jan 11, 2019
From: MICELL TECHNOLOGIES, INC.
To: MICELL SPV I LLC
Reel/Frame 048046/0907 →
SECURITY INTEREST Recorded Nov 5, 2018
From: MICHELL TECHNOLOGIES, INC.
To: HERCULES TECHNOLOGY GROWTH CAPITAL, INC.
Reel/Frame 047421/0273 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 16, 2014
From: MCCLAIN, JAMES B.; TAYLOR, CHARLES DOUGLAS
To: MICELL TECHNOLOGIES, INC.
Reel/Frame 032692/0435 →