ICM Injection System with Rotating Leaflet Mechanism
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Solution Overview
Problem
Existing implantable cardiac monitor (ICM) insertion systems face challenges in maintaining incision openness, maneuvering the device within tissue, and ensuring proper placement, particularly in patients with taut or loose tissue, and are difficult to remove.
Innovation Solution
An injection system comprising an injector housing with a rotating leaflet mechanism and a plunger handle that facilitates the deployment of the ICM by keeping the incision open and guiding its placement, ensuring minimal space between the ICM and surrounding tissue, and allowing for easy removal of the housing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Weight of moving object
If a small incision is used for ICM implantation, then patient body image concern is mitigated and procedure time is reduced, but the incision is relatively difficult to keep open during the procedure
Solution Approach 1:
The delivery device is divided into separate functional components: a needle component for creating the incision and pocket, and a separate ICM implantation tool for delivering the device. This segmentation allows the needle to create a precise small incision while the separate implantation tool maintains the incision open during ICM insertion, resolving the contradiction between small incision size and ease of maintaining incision openness.
2Ease of operation
If additional force is applied to insert the ICM in patients with taut tissue, then insertion is achieved, but the insertion system becomes more difficult to maneuver and may cause tissue damage
Solution Approach 1:
The needle component is used beforehand to pre-create a pocket in the subcutaneous tissue and pre-open the incision pathway before ICM insertion. This preliminary action eliminates the need to apply excessive force during ICM insertion, as the pathway is already prepared, thereby maintaining insertion capability while improving system maneuverability and reducing tissue damage risk.
3Ease of operation
If a large pocket is created for the ICM in patients with loose tissue, then insertion is facilitated, but the ICM may move after implantation
Solution Approach 1:
The needle component creates a localized pocket with controlled dimensions and characteristics tailored to the specific patient's tissue type. For patients with loose tissue, the pocket is created with tighter boundaries and appropriate depth control, ensuring the ICM is securely positioned without excessive movement while still facilitating easy insertion. This local quality adjustment resolves the contradiction between insertion ease and placement precision.
4Object-affected harmful factors
If the ICM has rounded edges for patient comfort, then patient comfort is improved, but it becomes relatively difficult to push the ICM into tissue
Solution Approach 1:
The needle component pre-creates the insertion pathway and pocket before the ICM is inserted. This preliminary action eliminates the need to push the ICM with rounded edges through tight tissue, as the pathway is already formed. The ICM can be gently guided into the pre-created pocket without requiring excessive force, thereby maintaining patient comfort while reducing insertion force requirements.
Data Source
AI summary
The present disclosure provides systems and methods for implanting an implantable cardiac monitor. An injection system includes an implantable cardiac monitor (ICM), a plunger, a plunger handle coupled the plunger, and an injector housing. The injector housing includes a tube extending from a first end of the injector housing to a second end of the injector housing, the tube configured to receive the ICM and the plunger, and at least one leaflet formed at the second end of the injector housing, the at least one leaflet configured to rotate outward when a user operates the plunger handle to push the ICM through the injector housing second end via the plunger.