Intra-cardiac Implant Hook Fixation for Dual-Chamber Pacing
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Solution Overview
Problem
Current micro leadless cardiac pacemakers face challenges in fixation within the cardiac chamber due to heart contractions and blood flow, leading to potential detachment, shifting, and inadequate contact between electrodes and myocardium, which affects pacing and sensing thresholds, and existing devices cannot achieve dual-chamber cardiac pacing due to lack of reticular myocardial structure in the atrium.
Innovation Solution
A laterally fixed intra-cardiac implant with a hook body and clamping structure, featuring a barb and rigid or shape-memory materials, is used for secure attachment to the myocardium, combined with an implantation device that includes an operating rod and catheter for precise placement and fixation, allowing for dual-chamber cardiac pacing without the need for leads or Bluetooth communication.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a single-end attachment manner (spiral metal wire or hook) is used for fixation, then the implant can be attached to the myocardium, but the implant may detach or shift due to heart contraction and blood flow
Solution Approach 1:
The fixation structure is divided into multiple independent hooks distributed around the implant housing, each capable of independently engaging the myocardium. This segmentation allows the fixation force to be distributed across multiple attachment points, preventing detachment while maintaining ease of implantation.
Solution Approach 2:
The hooks are designed with specific local geometries including barbs and clamping surfaces optimized for engaging myocardial tissue. The local quality of the hook structure (sharp tip for penetration, barb for anchoring, clamping surface for secure attachment) provides reliable fixation without requiring complex overall device design.
2Adaptability or versatility
If existing fixation devices are used, then attachment to ventricular myocardium is achieved, but atrial pacing cannot be performed due to lack of reticular myocardial structure
Solution Approach 1:
The hook fixation device is designed to be universally applicable to both ventricular and atrial chambers. The hooks can engage the different myocardial structures in both chambers effectively, enabling the same implant design to serve multiple functions across different cardiac chambers without compromising fixation reliability or pacing effectiveness.
Solution Approach 2:
The fixation structure incorporates dynamic elements that adapt to the specific mechanical properties of the myocardium in different chambers. The hooks can deform and conform to the reticular structure of atrial myocardium or the denser ventricular myocardium, providing reliable fixation in both locations.
3Object-affected harmful factors
If the implant is made small in volume, then infection rates are reduced and transvenous implant system complications are minimized, but fixation reliability is compromised
Solution Approach 1:
The fixation reliability is improved by transitioning from a single-point attachment to a multi-dimensional array of hooks distributed around the implant. This dimensional expansion of the fixation interface compensates for the reduced overall implant size, providing sufficient anchoring strength while maintaining the small volume that reduces infection risk.
Solution Approach 2:
The hooks are constructed from materials that combine rigidity for structural integrity with flexibility for tissue engagement. This composite material approach allows the small implant to achieve reliable fixation through optimized material properties rather than increased size.
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
The solution provides a reliable and safe fixation method that prevents shifting and improves contact between electrodes and myocardium, enabling effective dual-chamber cardiac pacing by securely attaching the implant to the myocardium, thus enhancing the reliability and safety of the micro implant.
Implementation Method 1
a hook body mounted at the sidewall of the housing and comprising a fixed end on the sidewall and a free end stretching from the fixed end, wherein the hook body is configured to form a clamping structure with the sidewall, the free end comprises a tip on its top for piercing the myocardium
Implementation Method 2
the barb is made of semi-soft material or shape-memory alloy
Data Source
AI summary
Disclosed is an intra-cardiac implant, a device and a method for respectively implanting two connected intra-cardiac implants to two cardiac chambers at one time. The intra-cardiac implant comprises a columnar housing including a sidewall, a first terminal and a second terminal, a first connecting portion located at the first terminal of the housing and configured to connect with the implantation device; and a hook body mounted at the sidewall of the housing and comprising a fixed end on the sidewall and a free end stretching from the fixed end, wherein the hook body is configured to form a clamping structure with the sidewall, the free end comprises a tip on its top for piercing the myocardium, and the intra-cardiac implant is clamped between the hook body and the sidewall, so that the intra-cardiac implant is fixed on the myocardium.