Actively Deployable Shape Memory Clip for Sutureless Implant Fixation
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Solution Overview
Problem
Minimally invasive surgery for implanting medical devices is complex and time-consuming due to the need for suturing, which increases surgical duration and morbidity.
Innovation Solution
The use of actively deployable fixation clips made from elastic or shape memory materials that deploy to securely anchor implantable medical devices, such as electrical stimulation leads, within body tissue, eliminating the need for sutures and reducing surgical complexity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If suture-based fixation is used, then reliable fixation of the implantable medical device is achieved, but surgical time and complexity increase significantly
Solution Approach 1:
The fixation clip is pre-formed from shape memory material in a compressed state that allows it to be delivered through the lead. Once deployed at the target site, the clip automatically expands to its full fixation shape, performing the fixation action in advance without requiring real-time suturing during surgery.
Solution Approach 2:
The patent replaces the manual suture-tying mechanical system with an automatically deploying shape memory clip system. The clip uses shape memory material properties to automatically expand and secure the lead without requiring surgical instruments, knots, or manual manipulation through cannulas.
2Reliability
If suture-based fixation is used, then secure anchoring of the device is achieved, but surgical complexity and difficulty increase
Solution Approach 1:
The fixation clip is designed to be self-deploying through shape memory material properties. Once the lead is positioned and the clip is released from its compressed delivery state, it automatically expands to its full fixation shape without requiring external surgical instruments or complex manipulation procedures.
Solution Approach 2:
The patent extracts the fixation function from the complex suture system and concentrates it into a single integrated clip component. This eliminates the need for separate sutures, needles, and knot-tying operations, simplifying the overall surgical procedure while maintaining secure fixation.
3Reliability
If multiple sutures are used for fixation, then robust fixation of the implantable medical device is achieved, but operative duration increases
Solution Approach 1:
The patent merges multiple fixation functions into a single integrated clip structure. The clip can be deployed at multiple positions along the lead to provide robust fixation equivalent to multiple sutures, but without the time-consuming process of individually placing and tying each suture.
Solution Approach 2:
The clip is pre-configured in a compressed delivery state that allows it to be positioned and deployed quickly. The shape memory material is pre-formed to automatically expand to the correct fixation shape upon deployment, eliminating the need for real-time surgical construction of fixation structures.
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 reduces surgical time and complexity, providing more robust fixation and minimizing surgical errors, allowing for easier and faster implantation of medical devices with multiple fixation points.
Implementation Method 1
The actively deployable fixation clip may be formed from an elastic material or shape memory material, and is operable to fixate the implantable medical device within or against body tissue. Upon deployment, the fixation clip initiates a shape change that causes the clip to assume a shape that provides fixation of the implantable medical device.
Implementation Method 2
The actively deployable fixation clip may be formed from an elastic material or shape memory material
Data Source
AI summary
A device comprises a medical implant and an actively deployable clip attached to the medical implant that operates to restrict movement of the medical implant once the actively deployable clip is deployed within a body of a patient. In some embodiments, the medical implant is an electrical lead for electrical stimulation. The actively deployable clip is operable to fixate the medical implant to a body tissue once deployed, such that the actively deployable clip performs a similar function to a suture. In this manner, embodiments of the invention may provide a medical implant that requires few or even no sutures to properly fixate the implant within the patient.