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Publication Number
US-12016972-B2
Publication Date
2024-06-25
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 an 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 method for controlled release of an active agent from a surgical repair graft. The surgical repair graft has 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. The graft is exposed to an aqueous fluid, and the bioabsorbable carrier matrix comprises the active agent and is degraded over time by the aqueous fluid to thereby release the active agent from the carrier matrix.
The bioabsorbable carrier matrix includes particles with non-concentric internally aqueous chambers surrounded by lipid membranes. In the multivesicular liposomes, one or more internally aqueous chambers and the lipid membranes contain the active agent. The particles are attached to the bioabsorbable carrier matrix at discrete attachment sites as islands that are spaced apart from each other to provide axial compliance to the surgical repair graft during bending.
In embodiments with biotextile pores, the active agent flows from the carrier matrix through the pores to a body region adjacent the biotextile layer. The degradation behavior includes degrading lipid membranes and chambers over time, including a configuration where exterior first-set membranes degrade before interior second-set membranes during the degrading step. Additional degradable components can be included, including adhering a hydrogel to at least one layer and degrading the hydrogel.
Claims Coverage
The independent claims are directed to three main aspects of controlled release from a surgical repair graft: exposing the graft with biotextile layers and a bioabsorbable carrier matrix attached to the layers to an aqueous fluid, degrading the carrier matrix over time to release an active agent, and defining carrier-matrix particles as non-concentric internally aqueous chamber particles in lipid membranes attached as spaced islands to provide axial compliance during bending.
Aqueous exposure and degradation to release active agent from graft-attached bioabsorbable carrier matrix
Exposing the 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, wherein the carrier matrix comprises the active agent, and degrading the carrier matrix over time by the aqueous fluid to thereby release the active agent from the carrier matrix.
Non-concentric internally aqueous chamber particles in lipid membranes
The bioabsorbable carrier matrix comprises particles each having non-concentric internally aqueous chambers, wherein the particles are surrounded by lipid membranes and one or more of the internally aqueous chambers and the lipid membranes contain the active agent.
Discrete island attachment providing axial compliance during bending
Attaching the particles to the bioabsorbable carrier matrix at discrete attachment sites as islands that are spaced apart from each other to provide axial compliance to the surgical repair graft during bending.
Multivesicular liposomes with non-concentric internally aqueous chambers
The bioabsorbable carrier matrix comprises particles including multivesicular liposomes having non-concentric internally aqueous chambers.
Across the independent claims, controlled release is obtained by aqueous exposure and time-dependent degradation of a graft-attached bioabsorbable carrier matrix containing active-agent-loaded particles defined by non-concentric internally aqueous chambers surrounded by lipid membranes. The particles are attached as spaced islands at discrete attachment sites to provide axial compliance during bending.
Stated Advantages
Provides axial compliance to the surgical repair graft during bending while releasing the active agent.
Documented Applications
Controlled release of an active agent from a surgical repair graft using aqueous-fluid exposure and degradation of a bioabsorbable carrier matrix attached to biotextile layers.
Release to a body region adjacent the biotextile layer through biotextile pores.
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