Cooling Compressive Hemostasis Device for Dynamic Vascular Motion
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Solution Overview
Problem
Current hemostasis devices for percutaneous access sites are inadequate in managing the dynamic and elastic nature of vascular injuries, leading to unpredictable bleeding complications and delayed hemostasis, as they fail to effectively promote platelet aggregation and fibrin formation, and often cause additional harm through excessive compression.
Innovation Solution
A topical hemostasis wound healing device that applies anatomically conforming compressive force and cooling to stabilize the vasculature, allowing for timely platelet aggregation and fibrin formation, while also providing lateral stabilization and promoting wound healing through a combination of a Lateral Stabilization Garment and a Cooling Pad or Compressive Cooling Device.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional mechanical barrier devices (seals, plugs, clamps) are used to stop bleeding, then immediate hemostasis is achieved, but the dynamic and elastic nature of blood vessels causes unpredictable bleeding complications and delayed hemostasis
Solution Approach 1:
The device transitions from static mechanical barriers to dynamic cooling compression that adapts to vascular motion. The cooling element actively reduces temperature to stabilize vasculature, while the compression element provides adjustable force that responds to the elastic nature of blood vessels, allowing the system to adapt to ongoing physiological movements rather than resisting them rigidly
Solution Approach 2:
The invention changes the physical parameter of temperature (cooling the vessel) and compression force (applying controlled pressure) to achieve hemostasis. By lowering temperature, the device reduces vascular elasticity and stabilizes the vessel wall, while controlled compression provides mechanical support without the rigid clamping of traditional devices, accommodating the dynamic nature of blood flow
2Reliability
If excessive compression is applied to achieve hemostasis, then bleeding is stopped, but additional harm is caused to the wound site
Solution Approach 1:
The device uses temperature reduction as an additional parameter to achieve hemostasis without relying solely on high compression forces. The cooling effect causes vasoconstriction and stabilizes the vessel wall, allowing for gentler compression that is sufficient to stop bleeding without causing excessive mechanical damage to the wound site
Solution Approach 2:
The invention partially replaces the purely mechanical compression system with a thermal field (cooling element). This substitution allows the device to achieve hemostasis through a combination of thermal and mechanical effects, reducing the need for excessive mechanical compression and thereby minimizing wound damage
3Reliability
If rigid clamping is used to stop arterial blood flow, then immediate hemostasis is achieved, but the elastic vessels disorient or dislocate the implant after initial success
Solution Approach 1:
The device employs dynamic cooling compression that can adapt to vessel movement rather than relying on rigid fixed-position clamping. The cooling element stabilizes the vessel wall through temperature reduction, while the compression element provides sustained gentle pressure that accommodates physiological motion, preventing device dislocation while maintaining hemostasis
Solution Approach 2:
The compression element is designed as a flexible component that can conform to and move with the elastic blood vessel rather than imposing a rigid structure. This flexibility allows the device to maintain contact and compression force despite vessel dislocation or movement, ensuring sustained hemostasis without device failure
4Reliability
If manual compression or rigid devices are used for hemostasis, then bleeding is controlled, but patient mobility is restricted and pain is increased
Solution Approach 1:
The device provides dynamic cooling compression that maintains hemostasis through active temperature control and adaptive pressure rather than rigid immobilization. This allows the patient to move more freely while the device continuously adjusts to maintain compression on the wound site, reducing pain and improving comfort without compromising bleeding control
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The device accelerates hemostasis, reduces bleeding complications, improves wound healing quality, and allows for gradual patient mobility, minimizing pain, inflammation, and scar formation, thereby enhancing clinical outcomes in percutaneous and surgical interventions.
Implementation Method 1
a cooling element which provides an initial cooling profile on the breached skin surface to cause vasoconstriction and hemostasis, and a follow-on cooling profile to stabilize the injured vasculature structure
Implementation Method 2
a compressive cooling device which delivers and transports a compressive pressure to the wound site and its anatomical vicinity
Implementation Method 3
The cooling compressive surface (CCS) may be formed of a thermally conductive material
Implementation Method 4
provides an initial cooling profile on the breached skin surface to cause vasoconstriction and hemostasis
Data Source
AI summary
A topical cooling compressive hemostasis wound healing device and methods thereof for affecting a percutaneous access site wound or an acute surgical wound. The device delivers and transports cooling to affect and control vasculature and musculoskeletal motions surrounding the injury site during the blood coagulation, hemostasis, and wound healing phases. The device has a viscoelastic and thermally conductive surface to deliver and transport an adjustable compressive pressure to resist outward blood flow, thus improving patient safety and clinical outcomes. The device is anatomically conforming and treats not only the specific injury site, but also its surrounding anatomical structures together as means to prevent unpredictable delayed hemostasis breach. The device provides comfort to the patient by allowing mobility upon wound healing, thus reducing back pain and strain resulting from being in a constrained position for a prolonged period of time which is known to cause additional medical events. The device reduces pain, inflammation, swelling, and scar formation on the injury site of a patient and promotes hemostasis, sustains hemostasis, and improves overall wound healing quality.