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EP-3402443-B1 - DEVICES AND COMPOSITIONS AND METHODS OF USE THEREOF

EP3402443B1EP 3402443 B1EP3402443 B1EP 3402443B1EP-3402443-B1

Inventors

  • HESS, BRIAN, J.
  • KAY, GEORGE, W.
  • MARCHENKO, ANDREY
  • BROWN, MICHAEL, C.
  • KOSH, David, J.

Dates

Publication Date
20260506
Application Date
20170112

Claims (15)

  1. An adhesive composition for use in a method of joining separated bones, wherein the method comprises: (1) forming a device for j oining the bones, wherein the device comprises: (a) a solidified form of the adhesive composition and a three dimensional fiber network, wherein the adhesive composition comprises a multivalent metal salt and an acidic compound and the acidic compound comprises: a compound of Formula (I) or a salt thereof wherein L is O, S, NH, or CH 2 ; each of R 1a and R 1b is independently H, optionally substituted alkyl, or optionally substituted aryl; R 2 is H, NR 4a R 4b , C(O)R 5 , or C(O)OR 5 ; R 3 is H, optionally substituted alkyl, or optionally substituted aryl; each of R 4a and R 4b is independently H, C(O)R 6 , or optionally substituted alkyl; R 5 is H, optionally substituted alkyl, or optionally substituted aryl; R 6 is optionally substituted alkyl or optionally substituted aryl; and each of x and y is independently 0, 1, 2, or 3; and (b) an additional layer of the adhesive composition in the working state present as a coating on a surface of the device or impregnated into or onto a surface of the device, wherein the working state of the adhesive composition is a pliable state adopted after mixing with an aqueous medium and prior to hardening, and the solidified form of the adhesive composition is formed after the reaction between the multivalent metal salt and the acidic compound has completed in the presence of an aqueous medium, and (2) applying the device at the interposition between the two separated bones.
  2. The adhesive composition for use of claim 1, wherein the device is in the form of a patch, plug, beam, plate, screw, rod, granule, spacer, cage, disc, tape device, or other shape determined by the geometry or anatomy of the site of application.
  3. The adhesive composition for use of claim 1 or claim 2, wherein the adhesive composition further comprises an additive or plurality of additives.
  4. The adhesive composition for use of claim 3, wherein the additive or plurality of additives comprises a pore forming agent.
  5. The adhesive composition for use of any one of claims 1-4, wherein the three dimensional fiber network material is in the form of a two or three-dimensional grid, lattice, mesh, mat, weave, braid, cloth, fabric, felt, web, open cell foam, sponge, sheet, membrane, cage, or gel.
  6. The adhesive composition for use of any one of claims 1-5, wherein the mean diameter of the three dimensional fiber network material is from 1 micrometer to 100 micrometers, or from 100 micrometers to 500 micrometers, or from 500 micrometers to 1000 micrometers.
  7. The adhesive composition for use of any one of claims 1-6, wherein the device is trimmed, milled, or stretched to a custom size.
  8. The adhesive composition for use of any one of claims 1-7, wherein the multivalent metal salt comprises tetracalcium phosphate or tricalcium phosphate.
  9. The adhesive composition for use of claim 1, wherein the three dimensional fiber network comprises a substantially biocompatible or substantially bioresorbable component.
  10. The adhesive composition for use of claim 9, wherein the biocompatible or bioresorbable component comprises calcium-based components, glass-ceramic or bioactive glass components, or one or more biopolymers.
  11. The adhesive composition for use of claim 1, wherein the device exhibits a porosity in the range of 1-99%.
  12. The adhesive composition for use of claim 1, wherein the three dimensional fiber network comprises a substantially non-resorbable component.
  13. The adhesive composition for use of claim 1, wherein the three dimensional fiber network comprises a mesh component, optionally wherein the three dimensional fiber network comprises elements, threads, or components that are structurally interconnected or intertwined.
  14. The adhesive composition for use of claim 1, wherein the amount of the acidic compound of Formula (I) comprises between 5% to 95% w/w of the total adhesive composition.
  15. The adhesive composition for use of claim 1, wherein the device is comprised of greater than 1% of the three dimensional fiber network material.

Description

CLAIM OF PRIORITY This application claims priority to U.S. Application No. 62/411,391, filed October 21, 2016, and U.S. Application No. 62/277,828, filed January 12, 2016. FIELD Embodiments of the disclosure relate to devices (e.g., patches, plugs, beams, plates, screws, rods, granules, spacers, cages, discs, tape devices, or other shape determined by the geometry or anatomy of the site of application) and methods of use thereof. BACKGROUND The repair of cracks, gaps, fissures, leaks, or other defects in objects can often be a difficult process that is incapable of restoring the original strength, integrity, and appearance to said object, particularly when said objects are subjected to a wet environment. US 2012/082705 A1, for example, describes compositions and methods of their use to adhere a variety of materials together. The compositions include tetra calcium phosphate and an effective amount of a compound that is structurally similar to phosphoserine, and can be mixed with an aqueous solution. Current practices do not seek to replace the missing void material, let alone enhance the strength and structural integrity of the damaged object. Instead, the goal is often to join separated objects or plug a leak, leaving the repaired region weak and vulnerable to repeated damage, especially in a wet environment. As such, there exists a need for new devices and methods for the repair of cracks, fissures, leaks, and other defects in objects, particularly in the surgical and industrial settings. The development of new adhesive compositions that can impart structural integrity to the object and enhance its original strength and performance, e.g., in a wet environment, provide opportunities to cure this need, particularly when used in combination with a setting framework such as a patch, tape, beam, plate, screw, rod, granule, spacer, cage, disc, plug, or other shape determined by the geometry or anatomy of the site of application. SUMMARY This application relates generally to devices and methods of fabrication and use thereof. In one aspect, the disclosure provides an adhesive composition for use in a method of joining separated (e.g., fractured) bones as defined in claim 1, wherein the method comprises forming a device for joining the bones and applying the device at the interposition between the two separated bones. The method may be to treat or heal a subject suffering from a disease or condition. The adhesive composition comprises a multivalent metal salt and an acidic compound. The device comprises a solidified form of the adhesive composition after a reaction between the multivalent metal salt and the acidic compound has completed in the presence of an aqueous medium. The device also comprises a three dimensional fiber network. The device also comprises an additional layer of the adhesive composition in its working state (i.e., after addition of aqueous medium becomes tacky and adhesive) that is coated or impregnated into or onto the surface of the solidified form and allowed to cure during its method of use. In any and all aspects, the adhesive device may take the form of a patch, plug, beam, plate, screw, rod, granule, spacer, cage, disc, tape device, or other shape determined by the geometry or anatomy of the site of application. In some embodiments, the three dimensional fiber network material is in the form of a two or three-dimensional grid, lattice, mesh, mat, weave, braid, cloth, fabric, felt, web, open cell foam, sponge, sheet, membrane, cage, or gel. In some embodiments, the mean diameter of the three dimensional fiber network material is from about 25 nanometers to about 500 nanometers or from about 500 nanometers to about 1000 nanometers. In some embodiments, the mean diameter of the three dimensional fiber network material is from 1 micrometer to 100 micrometers, or from 100 micrometers to 500 micrometers, or from 500 micrometers to 1000 micrometers. In some embodiments, the mean diameter of the three dimensional fiber network material is from about 1 millimeter to about 5 millimeters. In some embodiments, the adhesive device comprises more than one three dimensional fiber network, each exhibiting a different mean diameter. In some embodiments, the three dimensional fiber network comprises a substantially biocompatible or substantially bioresorbable component. In some embodiments, the biocompatible or bioresorbable component comprises poly(L-lactide), poly(D,L-lactide), poly(glycolide), poly(ε-caprolactone), poly(carbonate), poly(ethylene), poly(teramethylglycolic-acid), poly(dioxanone), poly(hydroxybutyrate), poly(hydroxyvalerate), poly(L-lactide-co-glycolide), poly(glycolide-co-trimethylene-carbonate), poly(glycolide-co-caprolactone), poly(glycolide-co-dioxanone-co-trimethylene-carbonate), poly(tetramethylglycolic-acid-co-dioxanone-co-trimethylene-carbonate), poly(glycolide-co-caprolactone-co-L-lactide-co-trimethylene-carbonate), poly(hydroxybutyrate-co-hydroxyvalerate), poly(methyl-methacryla