Lumenectomy Catheter Segmented Design for Tissue Sampling
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Solution Overview
Problem
Current atherectomy catheters face challenges such as difficulty in capturing occluding material, limited material removal capacity, and insufficient sample quantity and quality for accurate disease testing, particularly in accessing tortuous vascular regions and maintaining optimal catheter size for effective treatment and diagnosis.
Innovation Solution
The method involves collecting continuous tissue strands from body lumens using lumenectomy catheters, which provide sufficient material for testing disease markers like hypertension, hyperlipidemia, and diabetes, enabling advanced diagnostic and prognostic testing through genomic, proteomic, and biochemical methods.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If the cutting aperture is elongated to increase material capture area, then material capture capability is improved, but catheter length increases making it difficult to access tortuous vascular regions
Solution Approach 1:
The catheter is divided into multiple segments including a flexible cutter housing, a separate balloon, and a shaft with distinct functional zones. This segmentation allows each component to be optimized independently - the cutter housing can be elongated for material capture while the overall catheter maintains flexibility through segmented construction with articulation points.
Solution Approach 2:
The cutter housing and catheter shaft incorporate flexible materials and thin-film constructions that allow the catheter to bend and navigate tortuous vascular paths. The flexible housing maintains structural integrity for material capture while conforming to curved vessel geometries, resolving the contradiction between length/structure and navigability.
2Productivity
If a balloon is added to urge the cutting window into contact with occluding material, then material removal effectiveness is improved, but catheter size increases
Solution Approach 1:
The balloon and cutter housing are merged into an integrated assembly where the balloon is positioned within or adjacent to the housing structure. This combining allows the balloon to provide urging force for material removal while sharing the same spatial envelope as the cutter, preventing excessive size increase.
Solution Approach 2:
The balloon is nested within the cutter housing structure, with the balloon inflating inside the housing volume. This nesting arrangement allows the balloon to function for material removal while contained within the existing housing boundaries, minimizing overall catheter size increase.
3Productivity
If conventional atherectomy catheters are used, then basic material removal is achieved, but insufficient tissue sample quantity and quality is obtained for comprehensive biochemical and molecular testing
Solution Approach 1:
The catheter is designed to collect and store tissue samples in a preserved state during the procedure, preparing them in advance for subsequent comprehensive testing. The housing incorporates storage compartments and preservation mechanisms that maintain sample integrity, enabling multiple biochemical and molecular tests to be performed on sufficient tissue quantity.
Data Source
AI summary
Lumenectomy material is tested to determine the presence or likelihood of a condition of a patient. The lumenectomy material is in the form of at least one continuous tissue strand collected in vivo from an inner surface of a body lumen of the patient. The presence of at least one marker of a disease is determined. The disease may be hypertension, hyperlipidemia, depression, obesity, metabolic syndrome, insulin resistance, kidney damage, or diabetes. The patient is identified as having or as likely to develop the disease if a marker of the disease is identified in the lumenectomy material of the patient.