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Publication Number
US-11590262-B2
Publication Date
2023-02-28
Expiration Date
Abstract
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.
Core Innovation
The invention relates to a surgical repair graft for soft tissue reconstruction/repair that includes a plurality of stacked biotextile layers and a bioabsorbable carrier matrix. The carrier matrix comprises multivesicular liposomes attached to at least one of the biotextile layers, where each multivesicular liposome comprises a plurality of particles. Each particle includes a plurality of non-concentric internally aqueous chambers each surrounded by a lipid membrane.
At least one of the chambers and the lipid membrane contains an active agent. The particles are configured such that a first set of the chambers are on an exterior of the particles and a second set of the chambers are on an interior of the particles. Lipid membranes on the first set of the chambers are configured to degrade before the lipid membranes on the second set of the chambers, enabling time-dependent degradation and controlled release associated with the staged membrane degradation.
The disclosed graft configurations further include options in how the bioabsorbable carrier matrix and the stacked biotextile layers are incorporated, including biotextile layer pore size/porosity constraints and mechanical performance constraints during degradation. The document also describes additional structural features such as a covering with openings and interlayers such as a hydrogel that adheres and is chemically bonded to at least one of the carrier matrix or the multivesicular liposomes. A method is also disclosed for repairing an internal structure by controlled release of an active agent from an implanted surgical repair graft by exposing the graft to an aqueous fluid to degrade the carrier matrix over time.
Claims Coverage
The document provides three independent claims, covering (i) a surgical repair graft structure with staged degradation of liposome lipid membranes, (ii) a similar surgical repair graft using collagen-containing biotextile layers, and (iii) a method for repairing an internal structure via aqueous-fluid-driven degradation and controlled release from an implanted graft. Across these independent claims, the central inventive concepts are the stacked biotextile layers, a bioabsorbable carrier matrix of multivesicular liposomes with non-concentric internally aqueous chambers, and the configured degradation sequence of exterior versus interior chamber lipid membranes.
Staged degradation of non-concentric multivesicular chambers in attached liposome particles
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, where each multivesicular liposome comprises particles 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, with a first set of chambers on an exterior of the particles and a second set of chambers on an interior of the particles, and lipid membranes on the first set of chambers configured to degrade before lipid membranes on the second set of the chambers.
Collagen-containing stacked biotextile layers with staged degradation multivesicular liposomes
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, where each multivesicular liposome comprises particles 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, with a first set of chambers on an exterior of the particles and a second set of chambers on an interior of the particles, and lipid membranes on the first set of the chambers configured to degrade before lipid membranes on the second set of the chambers.
Aqueous-fluid exposure degrading implanted carrier matrix to release active agent with staged lipid membrane degradation
A method for repairing an internal structure by the controlled release of an active agent from an implanted surgical repair graft, 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, where the carrier matrix comprises multivesicular liposomes having particles with 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, with a first set of chambers on an exterior of the particles and a second set of chambers 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, where lipid membranes on the first set of the chambers are degraded before lipid membranes on the second set of the chambers.
Overall, the independent claims are directed to a surgical repair graft architecture and an associated method in which multivesicular liposomes having non-concentric internally aqueous chambers are attached to stacked biotextile layers, and the lipid membranes for exterior chambers degrade before those for interior chambers to drive staged degradation and controlled release of an active agent.
Stated Advantages
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