Self-assembling peptide gel formulation and methods of use
Inventors
Norchi, Terrence • Shah, Chirag • Ellis-Behnke, Rutledge
Assignees
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Publication Number
US-12390552-B2
Publication Date
2025-08-19
Expiration Date
Abstract
Compositions containing self-assembling peptides and/or self-assembling peptidomimetics (“self-assembling peptides”) can be used to create a long-lasting “lift” or means of elevating tissue to be resected, dissected, manipulated or repaired, as a bulking agent, or as a tissue forming matrix by injection of a solution that forms a solid gel in situ, which is stable for a prolonged period of time from days to a month, is hemostatic, and may prevent adhesions. These self-assembling peptides and methods of use thereof enable better separation of tissues and visualization of margins, more durable and robust lifts, less need for frequent injections that carry risk of undesired perforation, and simultaneous management of adverse effects, such as bleeding, leaking, inflammation and iatrogenic injury during endoscopic, laparoscopic or other minimally invasive, or open surgical procedures in and/or on the body.
Core Innovation
The invention relates to administering in vivo to a site in or on a subject in need thereof an injectable, biocompatible formulation comprising one or more self-assembling peptides that form a lift or bulking agent. The formulation is designed to have a duration of at least 30 minutes and to persist for at least one hour, and the method includes administering an effective amount so that the formulation separates or delineates tissues and/or organs or tumors and provides a cushion or lift at a target site comprising a lesion.
The self-assembling peptides include RADARADARADARADA (SEQ ID NO: 1) and/or EARAEARAEARAEARA (SEQ ID NO: 89) in a concentration between about 2% up to about 6% w/v. The lift or bulking agent is configured to lift, separate, or tunnel beneath or besides tissues, lesions, or a medical apparatus selected from wires, durable equipment, and closure devices, and the formed structure provides internal support around and/or between tissues or organs.
The invention further enables visualization or access to tissue or margins during a procedure and can provide a bulking agent. The matrix is described as being for creation of new tissue, and the formulation can smooth wrinkles or scars. In addition, the method specifies an injection force of 13 N or greater for the injectable formulation.
Claims Coverage
The document provides one independent claim (clm-00001) describing an in vivo method. The main inventive features are as follows.
Injectable formulation forming a persistent lift or bulking agent
Administering in vivo to a site in or on a subject an effective amount of a biocompatible, injectable formulation comprising one or more self-assembling peptides that forms a lift or bulking agent having a duration of at least 30 minutes and persists for at least one hour.
Self-assembling peptides comprising RADARADARADARADA and/or EARAEARAEARAEARA
The self-assembling peptides comprise RADARADARADARADA (SEQ ID NO: 1) and/or EARAEARAEARAEARA (SEQ ID NO: 89) in a concentration between about 2% up to about 6% w/v.
Separation/delineation, cushioning, and tunneling support
Using the lift or bulking agent to separate or delineate tissues and/or organs or tumors; lift, separate, or tunnel beneath or besides tissues, lesions, or a medical apparatus selected from wires, durable equipment, and closure devices; and form a cushion or lift at a target site comprising a lesion.
Visualization/access and internal support structure
Providing a matrix to visualize or access tissue or margins during a procedure and to create an internal support structure that provides support around and/or between tissues or organs, enabling them to be stabilized, protected, recovered, and/or healed.
Injection force and multifunctionality including bulking agent, creation of new tissue, and smoothing
Administering the formulation having an injection force of 13 N or greater, wherein the formulation provides a bulking agent, provides a matrix for creation of new tissue, and/or smooths wrinkles or scars.
Independent claim clm-00001 defines an in vivo method using an injectable biocompatible formulation of specified self-assembling peptides at about 2% to about 6% w/v that forms a persistent lift/bulking agent with an injection force of 13 N or greater, enabling tissue separation/delineation, cushioning/tunneling, visualization/access, and an internal supportive structure, with further described multifunctionality including creation of new tissue and smoothing.
Stated Advantages
Separates or delineates tissues and/or organs or tumors
Lifts, separates, or tunnels beneath or besides tissues, lesions, or a medical apparatus
Provides a cushion or lift at a target site comprising a lesion
Enables visualization or access to tissue or margins during a procedure
Provides internal support for stabilization, protection, recovery, and/or healing
Provides a bulking agent
Provides a matrix for creation of new tissue
Smooths wrinkles or scars
Persists for at least one hour
Has an injection force of 13 N or greater
Documented Applications
Separating and visualizing biliary and pancreatic vessels during surgical procedures
Separating a tissue or tumor during resection or repair by injecting the formulation adjacent to the tissue or tumor so it solidifies into a lift, tunnel, or barrier that persists throughout the resection or repair
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