Siloxane-based artificial blockage to control bleeding
Inventors
Mukhopadhyay, Kausik • Rangan, Krishnaswamy Kasthuri • Sudarshan, Tirumalai Srinivas
Assignees
Publication Number
US-9707251-B2
Publication Date
2017-07-18
Expiration Date
2028-03-11
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Abstract
Two siloxane-based mixtures combine to form a soft or semi-solid matrix for forming an artificial blockage to control bleeding, particularly moderate to severe bleeding. The first component includes a homogeneous mixture or solution that includes a polymeric matrix, a surfactant, filler(s) and metal compound(s). The second component includes a homogeneous mixture or solution that includes a polymer(s), a filler(s), a surfactant, and hydrogen peroxide. The combination of the two components is carried out with adequate mixing using mechanical and micro-kinetic mixing mechanisms and can be performed in a field-ready delivery device.
Core Innovation
The invention discloses a two-component siloxane-based mixture designed to control moderate to severe bleeding by forming a soft or semi-solid matrix in situ. The two components are kept separate until use: the first contains a siloxane polymer, a curing agent, a surfactant, and a metal mixture including calcium oxide and iron oxides; the second contains a siloxane polymer, a surfactant, and hydrogen peroxide, with optional particle fillers. Upon mixing, these components rapidly form a conformable blockage that adheres to and fills wounds, creating an artificial blockage to arrest bleeding.
The problem addressed is the uncontrolled loss of blood from traumatic injuries, including punctures, lacerations, and tears that may cause rapid blood loss and death if not arrested quickly. Previous siloxane-based bandages have not employed a dual-component system as described and do not achieve the controlled expansion and rapid curing necessary for immediate formation of a hemostatic plug suitable for field and emergency use.
This invention achieves rapid in situ matrix formation via exothermic decomposition of hydrogen peroxide upon contact with the metal mixture, with iron oxides acting as negative co-catalysts to regulate expansion kinetics and prevent excessive heat generation. The matrix forms through both mechanical and micro-kinetic mixing, facilitated by a specialized delivery device containing two isolated chambers and an integrated mixing tip. The product is suited for emergency wound care, can be precisely applied at the injury site, and is formulated to minimize pain and maximize biocompatibility.
Claims Coverage
There are five independent claims in the patent, each outlining a core inventive feature related to the two-fluid component system, its composition, delivery device, method, and in situ matrix formation.
Two-fluid component injection device for in situ formation of a soft solid artificial blockage
A device comprising two isolated chambers, each holding a specific fluid component. The first chamber contains a siloxane polymer (about 75–90%), siloxane polymer curing agent (0.5–25%), a metal mixture (12–18%) of calcium oxide and iron oxides or calcium hydroxide and iron oxides, and optionally a surfactant (0–25%). The second chamber contains a siloxane polymer (75–85%), hydrogen peroxide (1–20%), and optionally a surfactant (0–25%). The device features a mixing tip for combining the components just prior to application, forming a soft solid hemostatic dressing injectable into a wound that conforms to irregular wound surfaces, with less than 5% residual hydrogen peroxide, and in which iron oxides act as negative co-catalysts.
Two-fluid component injection device with specified concentrations for ideal blockage formation
A specialized device wherein the first chamber includes about 84% siloxane polymer, 0.5–2% surfactant, 0.5–3% siloxane curing agent, and 12–18% metal mixture; and the second chamber holds about 82% siloxane polymer, 0.5–2% surfactant, 17.5% hydrogen peroxide, and 0.2% particle filler. This specific formulation provides optimized expansion and curing behavior for effective in situ bleeding control.
Soft solid hemostatic blockage composition formed in situ by using a two-fluid component injection device
A hemostatic matrix formed by mixing two separated fluid components immediately before or during application. The first includes about 75–90% siloxane polymer, 0–25% surfactant, 0.5–25% curing agent, and 12–18% of a calcium/iron or calcium hydroxide/iron metal mixture. The second contains about 75–85% siloxane polymer, 0–25% surfactant, 1–20% hydrogen peroxide, and 0–10% particle filler. This mixture produces a conformable artificial blockage for moderate to severe bleeding.
Soft solid hemostatic blockage composition with formula providing rapid expansion and set
The composition consists of a first component with about 84% siloxane polymer, 0.5–2% surfactant, 0.5–3% curing agent, and 12–18% calcium/iron oxide or hydroxide mixture; and a second with about 82% siloxane polymer, 0.5–2% surfactant, 17.5% hydrogen peroxide, and 0.2% particle filler. The composition rapidly cross-links and cures after mixing, conforming to irregular wound surfaces.
Method for in situ formation of a soft solid artificial blockage to control moderate to severe bleeding
A method comprising injecting from a two-fluid component injection device a composition that forms a soft solid blockage in a wound, wherein the two components are kept separate until mixing inside the mixing tip. One component contains the siloxane polymer, curing agent, and calcium/iron oxide mixture; the other includes siloxane polymer and hydrogen peroxide. The method details mixing within the device’s tip to form the matrix, which is then allowed to expand and conform to the wound, with less than 5% hydrogen peroxide remaining.
The claims establish a two-component siloxane-based hemostatic system, a delivery device with mixing features, and a method for producing an in situ expandable soft solid blockage for immediate control of moderate to severe bleeding.
Stated Advantages
The composition and device enable rapid in situ formation of a soft-solid matrix that effectively controls moderate to severe bleeding in emergency situations.
The unique two-component system facilitates fast curing and expansion, forming a conformal blockage even in irregular wound surfaces.
Formulation minimizes stinging and pain because hydrogen peroxide is nearly completely reacted, with less than 5% remaining in the final matrix.
Iron oxides act as negative co-catalysts, moderating the decomposition reaction and preventing excessive heat, thus eliminating the danger of wound burns.
The device and formulation are designed for error-proof, field-ready use, requiring no complex measurements or instructions.
The final hemostatic blockage allows the patient's natural clotting cascade to initiate, supporting physiological healing.
The cured product is biocompatible and non-toxic, passing cytotoxicity, sensitization, irritation, systemic toxicity, and hemolysis testing.
Device and components demonstrate stability and effectiveness over a broad temperature range and shelf-life, suitable for field and military use.
Documented Applications
Control of moderate to severe external or internal bleeding in humans and animals, including use on punctures, lacerations, gashes, and tears.
Emergency use for first responders such as paramedics, firefighters, lifeguards, and police officers.
Application on the battlefield or in remote, austere, or disaster environments.
Temporary wound dressing for controlling blood loss after intensive surgeries in hospitals.
Pre-hospital stabilization of hemorrhage to allow time for patient transfer and natural clotting.
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