Sealed Hydratable Hemostatic Implant for Controlled Catheter Closure
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Solution Overview
Problem
Existing vascular closure devices suffer from premature hydration of hydratable hemostatic implants due to exposure to body fluids, leading to asymmetric swelling and difficulty in deployment, and often leave materials behind or cause scar tissue formation.
Innovation Solution
A protective sleeve covers the hydratable hemostatic implant to prevent premature hydration, using a biodegradable plug to inhibit fluid leakage and a latch mechanism for controlled retraction, ensuring the implant is deployed correctly and biodegrades without leaving permanent materials.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a hydratable hemostatic implant is used to seal vascular penetrations, then hemostasis effectiveness is improved, but premature hydration causes asymmetric swelling and deployment difficulty
Solution Approach 1:
The patent applies preliminary action by pre-positioning the hemostatic implant in a dry, compressed state within the delivery device, and pre-positioning a fluid barrier to prevent premature hydration. The implant is prepared in advance but kept in a controlled state until deployment, ensuring it remains deployable while ready to function when needed.
Solution Approach 2:
The patent introduces a fluid barrier as an intermediary element between the body fluids and the hemostatic implant. This barrier mediates the interaction by blocking fluid contact during delivery and deployment, preventing premature hydration while allowing controlled deployment. The barrier is temporarily present during the critical deployment phase and then removed or dissolves.
2Reliability
If vascular closure devices leave material behind or cause scar tissue formation, then closure effectiveness is improved, but subsequent access to the same site becomes problematic
Solution Approach 1:
The patent applies discarding and recovering by using a biodegradable hemostatic implant that is intentionally designed to be temporary. The implant performs its closure function and then naturally degrades and is discarded by the body over time, leaving no permanent material behind. This allows the vascular site to remain accessible for future procedures while maintaining effective closure during the healing period.
Solution Approach 2:
The patent applies parameter changes by using materials with specific biodegradation properties. The implant material is selected to have controlled degradation rates that match the healing timeline, transforming from a functional barrier to a non-existent material as the vessel heals. This dynamic parameter change (from present to absent) resolves the contradiction between effective closure and future accessibility.
3Stability of the object's composition
If blood or body fluids penetrate beneath the protective sleeve during introduction, then the implant can be hydrated, but asymmetric swelling occurs and compromises occlusion
Solution Approach 1:
The patent applies beforehand cushioning by pre-positioning a fluid barrier beneath the protective sleeve to cushion against and prevent fluid penetration. This barrier is in place before any potential fluid contact, creating a protective layer that absorbs or blocks harmful fluid exposure during the vulnerable introduction and deployment phase.
Solution Approach 2:
The fluid barrier serves as an intermediary that mediates between the harmful body fluids and the sensitive hemostatic implant. It allows the implant to remain protected during introduction while enabling controlled deployment, preventing direct harmful interaction between fluids and the implant material during the critical pre-deployment phase.
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 solution effectively seals vascular penetrations with reduced scar tissue formation and faster healing, allowing for subsequent procedures without residual implants.
Implementation Method 1
The hydratable hemostatic implant is biodegradable and will swell and fully occlude the tissue tract when exposed by retraction of a protective sleeve
Implementation Method 2
using a biodegradable plug to inhibit fluid leakage
Implementation Method 3
The hydratable hemostatic implant is biodegradable and will swell and fully occlude the tissue tract when exposed by retraction of a protective sleeve
Data Source
AI summary
Apparatus for sealing a vascular wall penetration disposed at the end of the tissue tract comprises a shaft, an optional occlusion element, a hydratable hemostatic implant, and a protective sleeve. The apparatus is deployed through the tissue tract with the occlusion element optionally occluding the vascular wall penetration and inhibiting backbleeding therethrough. The hydratable hemostatic implant, which will typically be a biodegradable polymer such as collagen carrying an anti-proliferative agent or coagulation promoter, will then be deployed from the sealing apparatus by retracting the protective sleeve and left in place to enhance closure of the vascular wall penetration with minimum scarring. The hydratable implant will be protected from premature hydration and swelling by a soluble plug covering the implant's distal end prior to sleeve retraction.