Method of forming a hemostatic product
Inventors
Olson, Curtis E. • Messina, Philip A. • Jackson, Brian Jeffrey
Assignees
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Publication Number
US-9597425-B2
Publication Date
2017-03-21
Expiration Date
Abstract
A method of forming hemostatic sheets. Dextran and water are mixed to form a dextran-water mixture. The dextran-water mixture is formed into a first support layer. Fibrinogen and thrombin are mixed to form a fibrinogen and thrombin mixture. The fibrinogen and thrombin mixture is dispersed on the first support layer to form a hemostatic sheet.
Core Innovation
The invention relates to a method of achieving hemostasis as a hemostatic vascular access device that is inserted into a body. The method forms a hemostatic sheet by mixing dextran and water to create a dextran-water mixture, forming the dextran-water mixture into a first support layer, and dispersing a fibrinogen and thrombin mixture on the first support layer to form a hemostatic sheet.
The hemostatic sheet is placed at least half way around a vascular access device before inserting at least a portion of the hemostatic vascular access device into the body, wherein the inserting step causes bleeding. The method relies on dissolution when contacted with blood, dissolving at least a portion of the hemostatic sheet upon contact with blood so that fibrinogen and thrombin contact the blood, and hemostasis is achieved when the fibrinogen and thrombin contact the blood.
The documented embodiments include configuring the dextran-based first support layer, including electrospinning into fibers and optional compressed electrospun dextran, and dispersing the fibrinogen and thrombin mixture to form a hemostatic sheet. Comparative animal testing results are described using a swine liver injury model and comparing against TACHOSIL, with reported outcomes including faster time to hemostasis, fewer additional compressions, improved fibrin formation, and reduced need for repeat compression.
Claims Coverage
The partial content provides three independent methods. Across these independent claims, there are 3 main inventive feature groups centered on a dextran-water support layer and dissolvable hemostatic sheet, positioning of the sheet around a vascular access device during insertion with blood-triggered dissolution, and composition variants for the hemostatic sheet including fibrinogen and thrombin mixtures or fibrinogen with thrombin incorporated into the dextran-water mixture, with optional additional agents.
Dextran-water first support layer carrying a fibrinogen and thrombin dispersed hemostatic sheet
Mixing dextran and water to form a dextran-water mixture; forming the dextran-water mixture into a first support layer; mixing fibrinogen and thrombin to form a fibrinogen and thrombin mixture; and dispersing the fibrinogen and thrombin mixture on the first support layer to form a hemostatic sheet.
At least half way around a vascular access device with blood-contact dissolution triggering fibrinogen and thrombin
Placing the hemostatic sheet at least half way around a vascular access device; inserting at least a portion of the hemostatic vascular access device into the body, wherein the inserting step causes bleeding; dissolving at least a portion of the hemostatic sheet when contacted with blood; and achieving hemostasis when the fibrinogen and thrombin contact the blood.
Thrombin mixed into dextran-water and fibrinogen dispersed to form the hemostatic sheet
Mixing dextran and water to form a dextran-water mixture; mixing thrombin into the dextran-water mixture to form a dextran-thrombin-water mixture; forming the dextran-thrombin-water mixture into a first support layer; dispersing fibrinogen on the first support layer to form a hemostatic sheet; and placing the hemostatic sheet at least half way around a vascular access device.
Electrospinning dextran-water to form a first support layer and dispersing additional agents on the hemostatic sheet
Mixing dextran and water to form a dextran-water mixture; electrospinning the dextran-water mixture into a first support layer; dispersing antibiotics, medicaments that alleviate pain, growth factors, bone morphogenic proteins, vasoactive materials, inflammation reduction steroids and combinations thereof on the first support layer to form a hemostatic sheet; and placing the hemostatic sheet at least half way around a vascular access device.
Across the independent claims, claim coverage centers on a hemostatic sheet formed using a dextran-water derived first support layer, a hemostatic composition based on fibrinogen and thrombin, and placement at least half way around a vascular access device such that bleeding leads to dissolution upon blood contact and hemostasis when fibrinogen and thrombin contact blood. A further independent variation recites electrospinning the dextran-water mixture and dispersing selected additional agents on the first support layer to form the hemostatic sheet.
Stated Advantages
Faster time to hemostasis (reported in comparative animal testing versus TACHOSIL).
Fewer additional compressions (reported in comparative animal testing versus TACHOSIL).
Improved fibrin formation (reported in comparative animal testing versus TACHOSIL).
Reduced need for repeat compression (reported in comparative animal testing versus TACHOSIL).
Potential advantages relating to dextran solubility, flexibility, and reduced persistence of the carrier versus collagen sponge.
Documented Applications
Use as a hemostatic vascular access device inserted into a body, where insertion causes bleeding and the hemostatic sheet dissolves when contacted with blood to achieve hemostasis.
Penetrating wounds/bullet wounds are described as a motivation for rapid, easily delivered hemostasis.
Swine liver injury model used for comparative animal testing versus TACHOSIL, with outcomes reported for hemostasis performance.
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