Vascular Closure Device Asymmetric Force Surface
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Solution Overview
Problem
Current wound closure methods for endovascular interventions, such as PCI, are inefficient, prone to complications, and fail to achieve rapid hemostasis and ambulation due to variability in manual pressure application, requiring lengthy hospital stays and increased morbidity, especially with larger interventions where existing devices are inadequate.
Innovation Solution
A vascular closure device with a three-dimensionally asymmetric force-transmitting surface and a force-exerting assembly that applies consistent, varying forces to mimic optimal manual closure, using a suture and springs to secure the device and reduce blood pressure and flow, while minimizing foreign bodies and residual materials.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual pressure is applied for wound closure, then hemostasis can be achieved, but the time to ambulation is prolonged (4-6 hours) and the procedure is prone to variability and complications
Solution Approach 1:
The wound closure device is designed to automatically maintain consistent occlusive pressure on the arteriotomy site after deployment, eliminating the need for continuous manual pressure application. The device's mechanical structure and force-exerting assembly provide sustained self-regulated compression, enabling reliable hemostasis while allowing early patient ambulation (60 minutes for diagnostic procedures).
Solution Approach 2:
The force-exerting assembly acts as an intermediary mechanism between the operator's initial deployment action and the sustained wound closure requirement. It translates the initial deployment force into continuous, consistent occlusive pressure through mechanical elements such as springs or shape memory alloys, bridging the gap between one-time intervention and prolonged hemostatic need.
2Reliability
If two-handed manual pressure is applied to achieve optimal wound closure, then hemostasis improves, but the procedure becomes complex and requires careful training of medical personnel
Solution Approach 1:
The device extracts and automates the critical function of sustained occlusive pressure application from manual two-handed technique. By incorporating a force-exerting assembly with mechanical elements, the device removes the complexity of coordinated hand positioning and pressure maintenance from the operator, reducing the procedure to a single deployment action while maintaining reliable hemostasis.
Solution Approach 2:
The force-exerting assembly provides self-regulated pressure application without requiring continuous operator intervention or complex manual coordination. The mechanical system automatically maintains appropriate force on the arteriotomy site, eliminating the need for trained two-handed technique while achieving equivalent or superior hemostatic results.
3Reliability
If manual pressure is applied during wound closure, then hemostasis can be achieved, but the applied pressure varies over time and may disrupt clot maturation
Solution Approach 1:
The device's force-exerting assembly automatically maintains consistent occlusive pressure through its mechanical design, eliminating the variability inherent in manual pressure application. The system self-regulates to provide stable, uninterrupted compression that supports clot maturation without requiring operator attention or adjustment.
Solution Approach 2:
The mechanical force-exerting assembly ensures continuous, uninterrupted occlusive pressure is applied to the arteriotomy site from deployment through hemostasis achievement. This continuous action prevents pressure gaps that could disrupt clot formation, maintaining stable conditions throughout the critical closure period.
4Adaptability or versatility
If existing vascular closure devices are used for larger interventions, then some closure capability is provided, but they are inadequate and leave residual foreign bodies in the patient
Solution Approach 1:
The device is designed to be completely removed after deployment, with no permanent foreign bodies remaining in the patient. The force-exerting assembly and anchoring mechanisms are temporary, serving their hemostatic function and then being fully extracted, eliminating the long-term presence of anchors, plugs, or other implantable components associated with existing closure devices.
Solution Approach 2:
The device provides universal applicability across different intervention sizes and patient anatomies while maintaining the capability for complete removal. The force-exerting assembly and anchoring system are designed to accommodate varying vascular access requirements without compromising the ability to fully extract the device, making it suitable for both small and large interventions without leaving residual materials.
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 achieves a complication rate of <1.5%, reduces time to hemostasis and ambulation to 60 minutes for diagnostic procedures, and is cost-effective, suitable for various patient anatomies, including obese patients, without leaving residual drugs or anchoring devices.
Implementation Method 1
a force-exerting assembly operable to create forces which generate relatively high pressures on the patient's skin and tissue adjacent the wound
Data Source
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AI summary
Wound closure apparatus (30) is provided including a body (32) having an elongated, lowermost force-transmitting surface (72) operable to be placed in a proximal, external, wound-closing position on a patient, together with a force-exerting assembly (34) coupled with the body (32) and operable to exert a downwardly directed force serving to generate wound-closing pressure against the patient's tissue. The force-transmitting surface (72) is preferably three-dimensionally asymmetric so that forces of different magnitude are exerted at different locations along the length of the surface (72). The apparatus (30) is especially designed for the closure of wounds attendant to endovascular interventions, e.g., a femoral artery puncture wound (138) incident to percutaneous cardiac intervention (PCI), wherein the wound (138) has an insertion site (142), an oblique tract (144) within the patient's tissue (140), and an arteriotomy (146). In such uses, the apparatus (30) is positioned and operated so as to partially close the patient's artery (148) upstream of the arteriotomy (146), thereby lessening the patient's blood flow at the arteriotomy (146). The apparatus (30) is capable of quickly effecting wound closure with a time-to-ambulation (TTA) of approximately 60 minutes, and a very low complication rate. The apparatus and methods hereof may also be used for the closure of wounds created during venous intervention procedures.