Medical Device Release System Using Nitinol Securement Member
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Solution Overview
Problem
Current medical devices for intracorporeal use lack efficient mechanisms for releasing medical implants, requiring multiple motions and materials that are prone to kinking or fatigue, which complicates the deployment process.
Innovation Solution
A medical device system featuring a release mechanism with a super-elastic nitinol securement member and a release wire, where the securement member can be snapped into two pieces in a single motion, allowing the release wire to translate and release the medical device from the elongate shaft, utilizing a tubular structure with radially aligned slots for easy deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If traditional release mechanisms are used, then the medical device can be released, but multiple motions are required and materials are prone to kinking or fatigue
Solution Approach 1:
The patent changes the material parameter from traditional metals to super-elastic nitinol alloy, which fundamentally alters the mechanical properties to eliminate kinking and fatigue while enabling single-motion operation. The super-elastic property allows the securement member to undergo large deformations without permanent damage.
Solution Approach 2:
The securement member is designed with a release point that segments it into two pieces upon activation. This segmentation allows the proximal portion to be pulled separately to release the medical device, simplifying the operation to a single motion while maintaining structural integrity during delivery.
2Reliability
If traditional securement members are used, then the medical device is secured to the shaft, but the deployment process is complicated
Solution Approach 1:
The securement member is pre-configured with a release point and radially aligned slots during manufacturing. This preliminary preparation allows the complex release function to be achieved through a simple single-motion pull, eliminating the need for complicated deployment procedures while maintaining secure attachment during delivery.
Solution Approach 2:
The release function is extracted as a separate feature (release point with slots) from the main securement structure. This allows the securement member to perform its primary function of securing the medical device while having a dedicated mechanism for simple release, reducing overall deployment complexity.
3Strength
If the securement member is made from traditional materials, then it provides structural support, but it is prone to kinking and fatigue
Solution Approach 1:
The patent employs super-elastic nitinol alloy, which combines the strength of metal with enhanced elasticity and fatigue resistance. This material provides the necessary structural support while eliminating the harmful effects of kinking and fatigue that plague traditional materials.
Solution Approach 2:
By changing the material parameter to super-elastic nitinol, the securement member gains the ability to withstand repeated deformations without fatigue and resists permanent kinking, while maintaining adequate structural strength for securing the medical device to the shaft.
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
Enables efficient and reliable release of medical devices with a single motion, preventing kinking and reducing material fatigue, facilitating precise deployment at treatment sites.
Implementation Method 1
A tubular super-elastic nitinol securement member includes a release point formed within the securement member
Data Source
AI summary
A medical device system may include an elongate shaft having a lumen extending from a proximal end of the elongate shaft to a distal end of the elongate shaft, a medical device disposed proximate the distal end of the elongate shaft, a release wire disposed within the lumen of the elongate shaft, wherein the release wire releasably secures the medical device to the distal end of the elongate shaft, a securement member fixedly attached to the proximal end of the elongate shaft and to a proximal end of the release wire, and a microcatheter configured to deliver the medical device to a treatment site, the elongate shaft and the medical device being slidably disposed within a lumen of the microcatheter. A proximal portion of the securement member may be configured to disengage from a distal portion of the securement member.