University of Pennsylvania

Massachusetts Institute of Technology

Synthes Usa, LLC

Regeltec, Inc.

Depuy Synthes Products, Inc.

North Carolina State University

Thomas P Schaer

Michael F Keane

Edward Vresilovic

Peter M Wilson

Alexander M Klibanov

Wamis Singhatat

Erik Brewer

Anthony M Lowman

Nigel Gordon Smith

Amy Arthur

Suzanne Stewart

Lauren V Schnabel

Jessica M Gilbertie

The present disclosure relates to hydrogels and their use for repairing or supplementing body tissue. The hydrogels are capable of safe injection into patients through fine gauge needles and are suitable for repairing, supplementing, or replacing the nucleus pulposus of an intervertebral disc. Methods of manufacturing and methods of using the hydrogels of the present disclosure to repair or replace tissues are also disclosed.

Hydrogels and method of making the same

An acellular, anion-depleted platelet-derived peptide-rich composition comprising proteins, polypeptides and peptides <10 kDa in size, wherein the composition has anti-microbial and/or anti-inflammatory activity is disclosed. The composition can be substantially free of non-active and immunogenic factors. The composition can have a platelet-to-bacteria ratio ≥1000:1. The composition can comprise plasma at a range of ≥10% to ≤50% plasma, optionally about 10% plasma. Methods of using the composition are also disclosed. Also disclosed is a method for preparing an acellular platelet-derived peptide-rich composition having anti-microbial and/or anti-inflammatory activity, the method comprising: providing a starting material comprising platelet-rich plasma processed to contain ≥1,000,000 platelet/μL, ≤100 leukocytes/μL and ≤10 erythrocyte/μL in plasma; lysing and/or activating the starting material; contacting the starting material with an ion exchange matrix and/or a size exchange matrix; and isolating the acellular platelet-derived peptide-rich composition.

Cationic platelet lysate compositions and related methods

Orthopedic and dental implants coated with an antibacterial coating and methods of making and using, are described herein. The implant can be coated with a hydrophobic, polycationic antibacterial polymer. The polymer can be covalently or non-covalently associated with the surface; however, in particular embodiments, the polymer is non-covalently associated with the surface. As shown in the examples below, clinical observations, digital radiography, and a battery of well-accepted ex vivo analytical methods show that the presence of a hydrophobic polycationic polymer coating, such as N,N-dodecyl,methyl-PEI coating on the surface of a metal implant, was effective in eliminating the clinical signs of infection in vivo in a large animal infection model. Moreover, the coated plates supported bone healing, and in fact decreased healing times, even in the presence of significant bacterial contamination compared to a control.

Antibacterial coatings that inhibit biofilm formation on implants

An instrument for inserting an elongated hydrogel prosthesis into an intervertebral disc includes an insertion cannula that is inserted through the annulus fibrosus of an intervertebral disc to provide access to the nucleus region of the disc, an elongated hydrogel prosthesis packaged within a tubular container adapted to be coupled to a proximal end of the insertion cannula, and a source of fluid pressure adapted to be coupled to a proximal end of the tubular container. Auxiliary instruments for use in convenient insertion of the insertion cannula through the nucleus pulposus and providing for a complete and controlled passage of the hydrogel prosthesis through the insertion cannula are provided in a kit with the insertion cannula. A sizing apparatus for determining the volume of prosthesis to be inserted includes a catheter or cannula capable of being inserted through the insertion cannula into the nucleus region of the intervertebral disc and having at its distal end a balloon capable of being inflated within the intervertebral disc with a measurable volume of a fluid in order to determine the amount of hydrogel prosthesis to be injected.

Method and apparatus for implanting a hydrogel prosthesis for a nucleus pulposus

A degenerated nucleus pulposus located in a central core region of an intervertebral disc within the annulus fibrosus is supplemented or replaced by a method wherein an amount of a biocompatible material is introduced into the central core region by a process including the steps of 1) forming a channel through a vertebral body adjacent to said intervertebral disc, extending from an exterior surface of the vertebral body to the central core region of the annulus fibrosus; 2) introducing an amount of a biocompatible material through the channel into the central core region of the annulus fibrosus; 3) pressurizing the biocompatible material through the channel to a postsurgical pressure sufficient to alleviate symptoms caused by the degenerated nucleus pulposus; and 4) sealing the channel while maintaining the sufficient postsurgical pressure. After sealing the channel, a vertebroplasty may optionally be performed in the vertebra.

Supplementation or replacement of a nucleus pulposus of an intervertebral disc

Growing community of inventors

Landenberg, PA, United States of America

Thomas P Schaer