System and methods for soft-tissue augmentation

Inventors

Taylor, Alan G. • Lawrence, Bruce R • Wahl, Rebecca Hawkins

Assignees

Theramicro LLC

Abstract

Provided herein is an injectable composition including, in some embodiments, a soft-tissue augmenting agent and a vehicle for the soft-tissue augmenting agent formulated for augmenting one or more soft tissues of a human or animal. Also provided herein is a soft-tissue augmenting kit including, in some embodiments, a syringe and the injectable composition formulated for augmenting one or more soft tissues of a human or animal. Also provided herein is a method for augmenting one or more soft tissues of a human or animal including, in some embodiments, injecting the injectable composition into the one or more soft tissues of the human or animal.

Core Innovation

The core disclosure provides an injectable soft-tissue augmentation system in which a soft-tissue augmenting kit includes one or more injecting elements and an injectable composition with a soft-tissue augmenting agent and a vehicle for the soft-tissue augmenting agent. The kit is configured to augment one or more soft tissues of a human or animal, and one or more of the injecting elements are sterile for immediate use upon unpacking the soft-tissue augmenting kit.

The system specifies a first syringe and a second syringe that are pre-filled such that either of the first and second syringes is pre-filled with the soft-tissue augmenting agent and the other is pre-filled with the vehicle. A syringe connector is included and configured to facilitate coupling of the first syringe with the second syringe, placing the first syringe into fluid communication with the second syringe, so that the soft-tissue augmenting agent may be mixed with the vehicle during coupling.

During coupling, the soft-tissue augmenting agent is mixed with the vehicle thereby fanning the injectable composition for delivery. The composition and agent/vehicle options include saline with micronized dermis, hydrolyzed collagen with micronized dermis, and biologic and synthetic components, including micronized silicone particles, acrylic beads, synthetic polymers, and related synthetics, while the vehicle may include water, saline, buffered saline, liquid collagen, or silicone liquid.

Claims Coverage

The partial content includes two independent claims. Across the independent claims, the coverage centers on a sterile prefilled two-syringe kit with a syringe connector that places the syringes into fluid communication so the soft-tissue augmenting agent mixes with the vehicle to form a fanned injectable composition for delivery, with sterile injecting elements for immediate use upon unpacking.

Collectively, the independent claims cover a sterile soft-tissue augmenting kit having prefilled first and second syringes, a syringe connector that places the syringes into fluid communication so the soft-tissue augmenting agent mixes with the vehicle during coupling, thereby fanning a deliverable injectable composition for delivery. The claims further define measuring syringes with plungers and graduated barrels, and in one independent claim a needle comprising a 20 gauge or smaller.

Stated Advantages

Documented Applications