Surgical repair graft
The apparatuses and methods described herein relates generally to the field of active agent (drug) release from surgical grafts useful for soft tissue reconstruction, regeneration, or repair. More particularly, described herein are surgical grafts for soft tissue repair that include active agent that is released over time while advantageously matching the biomechanical properties of tissue during healing and recovery.
1. A surgical repair graft comprising:
a plurality of stacked biotextile layers; and
a bioabsorbable carrier matrix comprising multivesicular liposomes attached to at least one of the biotextile layers, wherein the multivesicular liposomes comprise a plurality of particles each having a plurality of non-concentric internally aqueous chambers each surrounded by a lipid membrane, at least one of the chambers and the lipid membrane containing an active agent, and wherein a first set of the chambers are on an exterior of the particles and a second set of chambers are on an interior of the particles, wherein lipid membranes on the first set of the chambers are configured to degrade before the lipid membranes on the second set of the chambers.
2. A surgical repair graft comprising:
a plurality of stacked biotextile layers, wherein at least one biotextile layer comprises collagen; and
a bioabsorbable carrier matrix comprising multivesicular liposomes attached to at least one of the biotextile layers, wherein the multivesicular liposomes comprise a plurality of particles each having a plurality of non-concentric internally aqueous chambers each surrounded by a lipid membrane, at least one of the aqueous chambers and the lipid membrane containing an active agent, and wherein a first set of the chambers are on an exterior of the particles and a second set of chambers are on an interior of the particles, wherein lipid membranes on the first set of the chambers are configured to degrade before the lipid membranes on the second set of the chambers.
3. The surgical repair graft of claim 2 wherein the internally aqueous chambers comprise the active agent.
4. The surgical repair graft of claim 2 wherein the lipid membrane comprises the active agent.
5. The surgical repair graft of claim 1 wherein the carrier matrix attached to the biotextile layer is discontinuous.
6. The surgical repair graft of claim 1 wherein the carrier matrix is attached to the biotextile layer at a plurality of discrete attachment sites.
7. The surgical repair graft of claim 1 wherein the carrier matrix is attached to the biotextile layer in a random pattern.
8. The surgical repair graft of claim 1 wherein the carrier matrix is attached to the biotextile layer at a plurality of discrete attachment sites in a fixed pattern.
9. The surgical repair graft of claim 1 wherein the carrier matrix comprises a covering.
10. The surgical repair graft of claim 1 wherein the carrier matrix comprises a covering having a plurality of openings.
11. The surgical repair graft of claim 1 wherein at least one biotextile layer has an open cell pore of between 0.5 mm and 6 mm diameter.
12. The surgical repair graft of claim 1 wherein the carrier matrix is between two of the biotextile layers.
13. The surgical repair graft of claim 1 wherein the active agent comprises an active pharmaceutical ingredient (API).
14. The surgical repair graft of claim 1 further comprising a polymer between the carrier matrix and the biotextile layer, the polymer adhering the carrier matrix to the biotextile layer.
15. The surgical repair graft of claim 1 further comprising a hydrogel between the carrier matrix and the biotextile layer, the hydrogel adhering the carrier matrix or the multivesicular liposomes to the biotextile layer wherein the hydrogel is chemically bonded, respectively to the carrier matrix or the multivesicular liposomes.
16. The surgical repair graft of claim 1 wherein a second of the biotextile layers is flexibly attached to a first of the biotextile layers with a pattern of discrete attachment sites having a density of attachment sites that is less than about 10 attachments/mm 2 .
17. The surgical repair graft of claim 1 wherein a difference in bending stiffness of the surgical repair graft changes by less than 20% when the carrier matrix is adhered thereto compared with a bending stiffness of a similar surgical repair graft without carrier matrix.
18. The surgical repair graft of claim 1 wherein a difference in burst strength of the surgical repair graft changes by less than 20% when the carrier matrix is adhered thereto compared with the burst strength of a similar surgical repair graft without carrier matrix.
19. The surgical repair graft of claim 1 wherein a difference in surface roughness of the layers changes by less than 20% when the carrier matrix is adhered thereto compared with a burst strength of a similar surgical repair graft without carrier matrix.
20. A method for repairing an internal structure by the controlled release of an active agent from an implanted surgical repair graft, the method comprising:
exposing a surgical repair graft having one biotextile layer or a plurality of stacked biotextile layers and a bioabsorbable carrier matrix attached to at least one of the one or plurality of stacked biotextile layers to an aqueous fluid, the carrier matrix comprising multivesicular liposomes, wherein the multivesicular liposomes comprise a plurality of particles each having a plurality of non-concentric internally aqueous chambers each surrounded by a lipid membrane, at least one of the chambers and the lipid membrane containing the active agent, wherein a first set of the chambers are on an exterior of the particles and a second set of chambers are on an interior of the particles; and
degrading the carrier matrix over time by the aqueous fluid to thereby release the active agent from the carrier matrix, wherein lipid membranes on the first set of the chambers are degraded before the lipid membranes on the second set of the chambers.
21. The method of claim 20 wherein at least one of the one biotextile layer or plurality of biotextile layers comprises pores, the method further comprising flowing active agent from the carrier matrix through the pores to thereby release active agent to a body region adjacent the biotextile layer.
22. The method of claim 20 wherein a hydrogel is adhered to at least one of the layers, the method further comprising degrading the hydrogel.
23. The method of claim 20 wherein a compliance strain of the surgical repair graft is between 10-30% at 16 N/cm prior to the degrading step.
24. The method of claim 20 wherein the active agent comprises an active pharmaceutical ingredient (API).
25. The surgical repair graft of claim 1 , wherein the plurality of stacked biotextile layers are stitched together.
26. The surgical repair graft of claim 1 , wherein the plurality of stacked biotextile layers are adhered together with an adhesive.