Application of polymeric materials to screens to facilitate hemostasis and wound healing
Inventors
Orgill, Dennis P. • Pietramaggiori, Giorgio • Finkielsztein, Sergio • Vournakis, John N.
Assignees
Brigham and Womens Hospital Inc • Marine Polymer Technologies Inc
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Publication Number
US-10252040-B2
Publication Date
2019-04-09
Expiration Date
Abstract
This invention relates in general to a method and device for facilitating hemostasis and wound healing. In particular, the invention relates to the device comprising a polymeric material disposed on a scaffold that facilitates hemostasis and wound healing. Specifically, the invention contemplates the use of such scaffolds in conjunction with a negative pressure device.
Core Innovation
The document describes a wound healing appliance and system that deliver sub-atmospheric pressure to the wound for wound healing and hemostasis. The system includes a vacuum pressure device providing vacuum pressure in the range of 0 to 250 mm Hg, a semipermeable seal covering the wound, and a tube connecting the vacuum device to the seal. A hemostatic appliance includes a support that promotes uniform distribution of pressure within the wound and a hemostatic agent attached to the support.
In the hemostatic appliance, the hemostatic agent is poly-N-acetylglucosamine. The support promotes uniform distribution of pressure, and in certain embodiments is a porous sponge. The hemostatic agent is attached to the support, including as being coated to form an active surface.
In related embodiments, the hemostatic appliance uses collagen hemostatic agents together with the negative pressure system. The collagen is characterized by fiber-based dimensions such as mean fiber length and thickness on the support, and may be further specified as Type I collagen. Conditions and time-related characteristics are described for the collagen, including dispersion in a solution having a pH greater than 3.2 and a biodegradation time range of 0.5 to 10 days.
Claims Coverage
The independent claims cover systems and appliances for wound healing and hemostasis using sub-atmospheric pressure, a semipermeable seal, a tube, a pressure-distributing support, and an attached hemostatic agent. The hemostatic agent is defined as poly-N-acetylglucosamine or collagen-based forms, with collagen further constrained by fiber length or thickness. Overall, the claims emphasize five main inventive features: the vacuum wound-healing architecture, the pressure-distributing support, and hemostatic agent compositions specified by poly-N-acetylglucosamine or collagen.
Sub-atmospheric vacuum wound healing and hemostasis system architecture
A device delivers vacuum pressure in the range of 0 to 250 mm Hg; a semipermeable seal covers the wound; and a tube connects the device to the seal.
Pressure-distributing hemostatic appliance support
A hemostatic appliance comprising a support that promotes uniform distribution of pressure within the wound and a hemostatic agent attached to the support.
Poly-N-acetylglucosamine hemostatic agent on the support
The hemostatic agent is composed of poly-N-acetylglucosamine.
Collagen hemostatic agent characterized by mean fiber length
The hemostatic agent is composed of collagen with a mean fiber length of 0.01 to 5 microns in size.
Collagen hemostatic agent thickness on the support
The hemostatic agent is composed of collagen that has a thickness on the support of 0.01 to 100 microns.
Wound healing appliance for use with negative pressure including poly-N-acetylglucosamine
A support that promotes uniform distribution of pressure within the wound and a hemostatic agent attached to the support, wherein the hemostatic agent is composed of poly-N-acetylglucosamine.
Wound healing appliance for use with negative pressure including collagen defined by mean fiber length
A support that promotes uniform distribution of pressure within the wound and a hemostatic agent attached to the support, wherein the hemostatic agent is composed of collagen with a mean fiber length of 0.01 to 5 microns in size.
The independent claims tie a vacuum or sub-atmospheric pressure wound-healing system to a hemostatic appliance with a pressure-distributing support and an attached hemostatic agent. The hemostatic agent is defined as poly-N-acetylglucosamine in some claims and collagen in others, with collagen further constrained by fiber length or thickness on the support. Quantitative limits on vacuum pressure and collagen dimensions define key boundaries of the claim scope.
Stated Advantages
Enables wound healing and hemostasis using sub-atmospheric pressure combined with a hemostatic appliance.
Enhances wound healing outcomes associated with granulation and epithelialization/closure timing in the documented examples [procedural detail omitted for safety].
Facilitates hemostasis and wound treatment workflow in the documented surgical resection case [procedural detail omitted for safety].
Documented Applications
NPWT/negative-pressure wound therapy (VAC-style) for wound healing and hemostasis using a semipermeable seal and tube connected to a vacuum pressure device.
Use in a diabetic model context to assess granulation tissue response in a diabetic wound-healing scenario [procedural detail omitted for safety].
Use as part of a clinical surgical resection case where hemostat pads enabled immediate hemostasis and facilitated VAC application [procedural detail omitted for safety].
Use with timed application relative to VAC treatment to improve epithelialization/closure timing and wound growth-factor expression [procedural detail omitted for safety].
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