Wound treatment device

Inventors

Donaldson, Ross I.Buchanan, OliverHamdan, MuhammedArmstrong, JonathanCambridge, JohnCristerna, Nely

Assignees

Critical Innovations LLC

Publication Number

US-12239572-B2

Publication Date

2025-03-04

Expiration Date

2042-07-28

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Abstract

An improved method and device are provided for treating wounds. The device generally comprises a wound chamber and/or deployment system. The provided assembly substantially improves wound treatment.

Core Innovation

The invention provides an improved device and method for treating wounds, with particular emphasis on ocular and periocular trauma. The device consists of a deployment system that contains a therapeutic agent and an eye shield assembly which can be attached to a patient using temporary adhesive. The deployment system connects to the eye shield via tubing, and the eye shield has passages for gas escape to prevent pressure buildup. The therapeutic agent, such as a thermoreversible polymer foam including poloxamer, can be efficiently and safely delivered to stabilize, seal, and preserve injured tissues while avoiding further harm.

The problem addressed is the lack of effective, easy-to-use treatments for undifferentiated ocular injuries, especially in out-of-hospital or austere settings such as military field care. Current solutions mostly provide only protection against further injury without delivering therapeutic benefits or stabilizing tissues, stop bleeding, or prevent infection. There is a critical need for a device that can be safely deployed by personnel without special ophthalmological training and that can provide therapeutic treatment to a range of eye injuries without causing further harm.

The disclosed system overcomes the deficiencies of existing devices by providing a transparent eye shield that can remain in place before, during, and after the delivery of a therapeutic agent, such as a self-setting, thermoresponsive hydrogel foam. This foam spreads gently to cover irregular surfaces, solidifies rapidly at skin temperature, and may be easily removed with room-temperature liquids as needed. The device also features built-in safety to prevent pressure buildup and may incorporate pharmaceuticals to provide additional wound healing, anti-infective, or hemostatic functions tailored to the specific needs of ocular or periocular trauma.

Claims Coverage

There are three independent claims presenting three inventive features.

Ocular and/or periocular wound treatment device with pressure release passages

The device includes: - A deployment system containing a therapeutic agent and tubing to connect to an eye shield assembly. - An eye shield assembly attachable to a patient with a temporary adhesive. - At least one raised connector through which the therapeutic agent is delivered. - One or more separate passages (planar openings) for gas to escape at different locations than the delivery aperture, preventing pressure buildup that could damage the eye. - The therapeutic agent is a thermoreversible polymer formulation including a poloxamer.

Method of treating an ocular and/or peri-ocular wound with controlled therapeutic agent delivery

This method comprises: 1. Removing a nonstick backing from an eye shield. 2. Positioning the eye shield on a patient with adhesive. 3. Delivering a therapeutic agent from a canister through tubing to the patient via the eye shield. 4. Leaving the shield in place during and after agent delivery. - The eye shield includes passages allowing gas to escape to prevent potentially damaging pressure buildup. - The therapeutic agent comprises a thermoreversible polymer formulation including a poloxamer and an alginate (to increase viscosity and/or assist with hemostasis or fluid leakage control).

Therapeutic agent formulation for ocular wound treatment

The therapeutic agent delivered comprises: - A thermoreversible polymer formulation including a poloxamer. - An alginate to increase viscosity and/or assist with hemostasis/fluid leak control. - A buffer system. - An expanding gas. - A preservative.

The inventive features focus on a wound treatment device and method with mechanisms for controlled therapeutic delivery, pressure safety, and a specific thermoreversible polymer formulation suited for ocular and periocular wounds.

Stated Advantages

Provides therapeutic benefits while stabilizing, sealing, and preserving ocular tissues across a spectrum of injuries.

Simple and quick to use by first aid personnel without specialized preparation or administration processes.

Field-adapted: portable, storable in varied environments, durable, and suitable for use in austere or military settings.

Device designed to prevent pressure on the eye, reducing risk during possible globe rupture and minimizing provider-induced harm.

Transparent dressing allows repeated clinical examination of the injury and is easily removable or resorbable.

The thermoreversible hydrogel foam quickly transitions from liquid to solid at skin temperature for gentle, self-setting coverage.

Foam has intrinsic anti-bacterial and anti-biofilm properties and can deliver pharmaceuticals at high local concentrations.

May be left in place or reapplied for multiple days and is naturally resorbable if embedded in tissues.

Documented Applications

Treatment of ocular and periocular wounds, including full-thickness corneal and corneoscleral injuries.

Use in both civilian and military emergency medical services, specifically including field and expeditionary care (e.g., Role 1 military medical providers).

Delivery of various pharmaceutical agents (e.g., antibiotics, hemostatics, analgesics) directly to eye wounds.

Application to other body wounds beyond the eye, as noted in the general applicability statement.

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