Occlusion Delivery and Removal Sheath for Intraluminal Access
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Solution Overview
Problem
Conventional methods for delivering and removing occlusive devices, such as hydrogels, in body lumens like the vas deferens and fallopian tubes face challenges including incorrect placement, patient discomfort, increased risk of perforation, and the need for multiple invasive steps, especially when using hypodermic needles.
Innovation Solution
The use of a sheath and probe system that confirms intraluminal access and minimizes invasiveness by ensuring proper placement before delivery or removal of occlusive materials, utilizing mechanisms like hydro-distension and spring-loaded probes to verify correct positioning, and employing split needles and catheters for percutaneous insertion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a hypodermic needle is used to deliver occlusive devices into body lumens, then the delivery can be achieved, but the risk of incorrect placement and unintended injection into interstitial spaces increases
Solution Approach 1:
The patent introduces a guide catheter as an intermediary device between the hypodermic needle and the body lumen. The needle is advanced through the catheter under fluoroscopic guidance, allowing real-time visualization to confirm proper positioning within the lumen before occlusive device delivery, thereby eliminating the risk of incorrect placement into interstitial spaces
Solution Approach 2:
The patent replaces blind mechanical needle insertion with fluoroscopic imaging guidance. The fluoroscopy system provides real-time visual feedback, substituting the purely mechanical hypodermic needle delivery system with an image-guided approach that enables precise positioning and confirmation of intraluminal placement
2Ease of operation
If the needle is left in place during the procedure to maintain access, then continuous access is maintained, but patient discomfort and pain increase due to unintentional movement
Solution Approach 1:
The patent extracts the sharp hypodermic needle from the body after successful occlusive device delivery. The needle is removed through the guide catheter, eliminating the source of patient discomfort and pain while maintaining procedural access through the softer, more comfortable guide catheter that remains in place
Solution Approach 2:
The guide catheter serves as an intermediary that maintains continuous access to the body lumen after needle removal. The catheter provides a stable, comfortable pathway for monitoring and potential additional interventions without the pain and discomfort associated with a retained sharp needle
3Ease of manufacture
If conventional needle systems are used for occlusive device delivery, then the procedure can be performed, but multiple invasive steps and increased complexity are required
Solution Approach 1:
The patent merges the delivery catheter and guide catheter into a single integrated system. The occlusive device is loaded into the delivery catheter, which is then advanced through the guide catheter in one continuous motion, eliminating the need for separate insertion steps and reducing overall procedural complexity despite the addition of imaging guidance
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
This approach enhances the safety and efficacy of occlusive device delivery and removal procedures by reducing patient discomfort, minimizing tissue damage, and simplifying the procedure with fewer steps, while ensuring accurate placement and patency restoration.
Implementation Method 1
spring-loaded probes to verify correct positioning
Implementation Method 2
mechanisms like hydro-distension and spring-loaded probes to verify correct positioning
Data Source
AI summary
Systems, devices, and methods for delivering one or multiple materials into a body space (e.g., to occlude the body space) and/or for removing one or multiple materials from a body space (e.g., to open or reopen the body space) are described. Delivering material into the vas deferens of the male reproductive tract for contraception, removing material from the vas deferens to restore patency of the vas deferens, delivering material into the fallopian tubes of the female reproductive tract for contraception, and removing material from fallopian tubes to restore patency of the fallopian tubes is described. Confirming access to a body space is described. Agitating materials in a body space is described. Creating turbulence in a body space is described.