Delivery system for in situ forming foams and methods of using the same
Inventors
Sharma, Upma • Busold, Rany • Rago, Adam • Zugates, Gregory T. • Freyman, Toby • Miller, Lisette Manrique
Assignees
Publication Number
US-10687795-B2
Publication Date
2020-06-23
Expiration Date
2030-08-24
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Abstract
Delivery systems for in situ forming foam formulations are provided. The devices may include various actuation mechanisms and may entrain air into fluid formulation components in a variety of ways, including mixing with air and the addition of compressed gas.
Core Innovation
The invention provides delivery systems for in situ forming foam formulations, specifically designed as medical devices to deliver the foams to sites on or within the body. The devices include a fluid cartridge with one or more chambers and corresponding pistons for adjusting chamber volume, at least one impeller located within a chamber, a static mixer with a tip configured for patient insertion, and actuators for moving pistons and/or impellers. The system can also optionally include mechanisms such as gas cylinders or motors for actuation.
The background identifies that in situ forming polymer foams have important biomedical applications, such as preventing or treating hemorrhage, especially in challenging or non-compressible wounds, vascular embolization, space filling, and more. However, practical delivery is difficult due to challenges aerating and mixing high-viscosity formulations, safely accessing target body sites, minimizing component count, and enabling rapid aeration and deployment in settings like the battlefield.
To address these challenges, the invention introduces mechanisms such as impeller-based aeration (e.g., through helical or mesh assemblies), static and dynamic mixers, actuator systems (e.g., squeeze handles, cranks, piston pumps), lockout mechanisms to prevent delivery of unaerated formulations, and adjustable dose sliders. The system is designed for simple assembly, versatility in actuation and access, and suitability for field or non-clinical environments where speed, safety, and reliable aeration/mixing are crucial.
Claims Coverage
There are two independent claims providing coverage for core device features and a specific mixer construction, each introducing distinct inventive features.
Medical device with integrated cartridge, impeller, static mixer, and actuator
A medical device comprises: - A fluid cartridge with at least one chamber whose volume is controlled by an internal piston. - At least one impeller positioned within the chamber. - A static mixer in fluid communication with the chamber, featuring a tip with multiple dispensing apertures suitable for insertion into a patient's body. - A first actuator designed to move at least one of the impeller and the piston for mixing, aeration, or delivery functions.
Static mixer with cylindrical shell, tapered end, and internal mixing elements
A medical device integrates: - A fluid cartridge having at least one chamber with an impeller and piston as described above. - A static mixer characterized by a substantially cylindrical outer shell that defines a lumen, the shell having a tapered end with multiple apertures, and a plurality of mixing elements disposed inside the lumen, where the mixing elements may include X-grids, beads, or mesh.
The claims define medical devices that combine fluid cartridges with internal impellers, static mixing devices capable of intrabody delivery, and actuators for controlled mixing, aeration, and dispensing, with special provisions for mixer construction and actuation.
Stated Advantages
Provides simple, familiar mechanisms for aeration and injection, enabling use in challenging or field settings such as combat without the need for power or compressed gas.
Allows for efficient aeration and mixing of even highly viscous formulations, enabling rapid deployment and thorough mixing essential for effective foam formation.
Design emphasizes ease of assembly and minimal component count, reducing preparation time and complexity for users.
Mechanisms such as lockout devices and ready indicators help ensure formulations are fully aerated prior to deployment, which may be crucial for efficacy and safety.
Adjustable dose sliders enable tailoring the quantity of foam delivered for different applications or patient sizes.
Documented Applications
Prevention or treatment of hemorrhage, particularly from non-compressible or difficult-to-visualize wounds, including severe abdominal, junctional, and/or pelvic hemorrhage.
Vascular embolization and treatment of arteriovenous malformation or AV fistulas.
Space filling and bulking after surgical resection or for cosmetic purposes.
Prevention of tissue adhesion and hernia repair.
Prevention or treatment of reflux.
Temporary or permanent occlusion of body lumens, such as for sterilization or prevention of calculus migration during lithotripsy.
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