Occlusion Balloon for Vascular Perforation Hemostasis
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Solution Overview
Problem
During cardiac lead removal procedures, accidental vascular perforations can occur, leading to significant blood loss due to the difficulty in effectively occluding the perforation site, as existing tools may inadvertently pierce or cut the vein, and current methods lack efficient means to promptly mitigate blood flow and facilitate surgical repair.
Innovation Solution
A temporary occlusion balloon device with a catheter shaft and an inflatable balloon, coated with a hemostatic composition, is introduced to occlude the perforation. The balloon, with a working length of 65-80 mm and an inflated diameter of 20-25 mm, is designed to be positioned proximate the perforation, and inflated with a fluid to occlude the site, utilizing a hemostatic composition to reduce blood flow and promote clotting.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing tools are used to occlude the perforation site, then the occlusion can be achieved, but the tools may inadvertently pierce or cut the vein, causing additional harm
Solution Approach 1:
The patent employs a flexible balloon that can be inflated to occlude the perforation site. The balloon's flexible nature allows it to conform to the vessel geometry and apply occlusion pressure without the rigid structure that would cause piercing or cutting, thus resolving the contradiction between effective occlusion and avoidance of additional vein damage
Solution Approach 2:
The balloon acts as an intermediary device between the occlusion goal and the vessel wall. Instead of directly applying clamps or forceps that could damage the vessel, the inflated balloon provides a distributed, controlled occlusion force that achieves hemostasis while minimizing mechanical trauma to the surrounding tissue
2Productivity
If current methods are used to address vascular perforation, then treatment can proceed, but blood loss is significant due to lack of efficient occlusion means
Solution Approach 1:
The balloon is inflated to occlude the perforation site before surgical repair is completed, establishing immediate hemostatic control. This preliminary occlusion action prevents ongoing blood loss and creates a controlled environment for subsequent surgical steps, allowing the surgical team to work more efficiently without the pressure of active bleeding
Solution Approach 2:
The device converts the harmful effect of blood flow through the perforation into a beneficial occlusion state. By inflating the balloon to block the vessel, the system transforms the uncontrolled blood loss situation into a controlled surgical field, enabling faster and safer repair while minimizing total blood loss
3Reliability
If a balloon with sufficient size is used to occlude the perforation, then occlusion effectiveness is improved, but the device complexity and catheter shaft dimensions increase
Solution Approach 1:
The catheter shaft is designed with separate lumens for inflation fluid delivery and blood drainage. This segmentation allows the balloon to be effectively sized for occlusion while the catheter structure remains manageable through functional separation, reducing overall device complexity despite the balloon's sufficient occlusion dimensions
Solution Approach 2:
The balloon provides occlusion in the radial dimension (expanding outward to seal the perforation) while the catheter shaft maintains a small profile in the longitudinal dimension. This dimensional differentiation allows the balloon to be large enough for effective occlusion without proportionally increasing the catheter shaft's overall complexity and insertion profile
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 occlusion balloon effectively reduces blood loss, providing time for surgical repair by promoting hemostasis and maintaining the occlusion until the perforation can be addressed, thereby minimizing long-term harm to the patient.
Implementation Method 1
The balloon is designed to be positioned proximate the perforation, and inflated with a fluid to occlude the site
Implementation Method 2
The balloon, with a working length of 65-80 mm and an inflated diameter of 20-25 mm, is designed to be positioned proximate the perforation, and inflated with a fluid to occlude the site, utilizing a hemostatic composition to reduce blood flow and promote clotting
Data Source
AI summary
A device for occluding a perforation in a blood vessel includes a catheter shaft that has a first lumen and a second lumen. The first lumen is adapted to receive at least one of a guidewire and an implanted cardiac lead, and the second lumen is adapted to receive an inflation fluid. The device further includes an inflatable balloon that is carried by the catheter shaft. The inflatable balloon is adapted to receive the inflation fluid from the second lumen. The inflatable balloon has a working length of about 65 mm to about 80 mm and an inflated diameter of about 20 mm to about 25 mm.