Bioabsorbable Vascular Puncture Sealing Member
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Solution Overview
Problem
Existing methods for sealing vascular punctures are time-consuming, uncomfortable for patients, and carry risks of hematoma and embolism due to the prolonged presence of closure devices in the bloodstream, which can take days or weeks to resorb.
Innovation Solution
A device with a bioabsorbable sealing member that can be absorbed within 24 hours, along with an optional non-bioabsorbable filament, is delivered through a puncture to rapidly achieve hemostasis, using a delivery sheath and pusher member to deploy the sealing member against the vessel wall, and optionally accompanied by extravascular sealing material.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a bioabsorbable sealing member is used to seal the puncture, then the risk of embolism is reduced due to rapid absorption, but the device loses its sealing function too quickly before tissue healing is complete
Solution Approach 1:
The sealing system is divided into two distinct components: a rapidly absorbing intravascular sealing member (absorbed within 24 hours) and a slowly absorbing extravascular sealing member (absorbed within 7-14 days). This segmentation allows each component to perform its specific function at the appropriate time scale, resolving the contradiction between rapid embolism prevention and sustained puncture sealing.
Solution Approach 2:
Different absorption rates are assigned to different spatial locations: the intravascular portion uses fast-absorbing material to quickly eliminate embolism risk in the blood vessel, while the extravascular portion uses slow-absorbing material to maintain puncture closure during tissue healing. This local differentiation of material properties resolves the temporal contradiction.
2Reliability
If external pressure is applied to achieve hemostasis, then the puncture can be sealed, but the procedure becomes time-consuming and requires patient immobilization
Solution Approach 1:
The sealing members are pre-positioned within the puncture tract before the patient undergoes prolonged immobilization. The intravascular sealing member is deployed first to immediately stop bleeding, eliminating the need for extended external compression and reducing procedure time while maintaining reliable hemostasis.
3Duration of action of stationary object
If a non-bioabsorbable sealing device is used, then durable puncture closure is achieved, but the risk of embolism and hematoma increases due to prolonged presence in the bloodstream
Solution Approach 1:
The device is segmented into intravascular and extravascular portions with different absorption characteristics. The intravascular portion absorbs rapidly within 24 hours to eliminate embolism risk, while the extravascular portion provides durable sealing during the healing period. This segmentation resolves the contradiction between durability and safety.
Solution Approach 2:
The intravascular sealing member functions as a temporary, short-lived component that is rapidly absorbed after performing its immediate hemostasis function. This disposable approach eliminates the long-term risks associated with permanent implants while maintaining effective puncture closure during the critical healing period.
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 provides rapid and temporary hemostasis, minimizing the risk of embolism and hematoma by ensuring the sealing member is absorbed before the patient becomes ambulatory, while allowing for potential longer absorption of the filament, thus reducing complications.
Implementation Method 1
The sealing member may be made from any bioabsorbable material, e.g., a carbohydrate or salt-based material that rapidly dissolves in the presence of an aqueous environment, or a material that is melted or decomposed by the body's heat, or a material that is broken down by the body's enzymes into byproducts that are excreted by the body
Implementation Method 2
a material that is broken down by the body's enzymes into byproducts that are excreted by the body
Implementation Method 3
a material that is melted or decomposed by the body's heat
Data Source
AI summary
Apparatus for sealing a puncture communicating with a blood vessel includes a bioabsorbable sealing member secured to one end of a filament or other retaining member. The sealing member is delivered through the puncture into the vessel, and retracted against the wall of the vessel to provide temporary hemostasis. The sealing member is rapidly absorbed after exposure within the vessel, e.g., to an aqueous or heated physiological environment (e.g., exposure to blood or body temperature), immediately or shortly after completing a medical procedure via the puncture, e.g., within the time period that the patient is ambulatory. Optionally, extravascular sealing material is delivered into the puncture proximal to the sealing member. The retaining member and/or extravascular material may be bioabsorbable, being absorbed at a slower rate than the sealing member. Alternatively, the filament is removed from the puncture after hemostasis is established.