Modular Leadless Pacemaker with Reusable Base

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Solution Overview

Problem

Leadless capsules for cardiac stimulation have limited battery life, requiring frequent invasive surgeries for replacement, causing tissue trauma and invasiveness, with the anchoring system interfering with heart function and blood flow.

Innovation Solution

A modular design with a separable base and capsule body, allowing for reversible coupling using a fastening system, enabling reuse of the implantation site, minimizing tissue trauma, and reducing invasiveness by allowing the capsule body to be replaced without disturbing the anchoring structure.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of moving object

If a leadless capsule uses a battery power supply system, then the device achieves autonomous operation, but the battery life is limited resulting in frequent replacements

Engineering Contradiction:
Improvedevice lifespanVSAvoidreplacement frequency
Core Design Contradiction:
Duration of action of moving objectVSProductivity

Solution Approach 1:

The device is divided into two separate components: a reusable base with anchoring structure and a replaceable capsule body containing the battery. This segmentation allows the capsule body to be exchanged without removing the base, extending the overall device lifespan while maintaining autonomous operation.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The capsule body containing the depleted battery is discarded and replaced with a fresh capsule body, while the base with anchoring structure is recovered and reused. This approach extends device lifespan by recovering the durable base component.

Inventive Principle:
Principle #34Discarding and recovering

2Duration of action of moving object

If the entire leadless capsule is replaced, then the battery is renewed, but tissue trauma and surgical invasiveness increase

Engineering Contradiction:
Improvebattery lifeVSAvoidtissue trauma
Core Design Contradiction:
Duration of action of moving objectVSObject-affected harmful factors

Solution Approach 1:

By segmenting the device into a reusable base and replaceable capsule body, only the capsule body needs to be removed and replaced, not the entire device. This reduces the surgical intervention required and minimizes tissue trauma compared to complete capsule replacement.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The capsule body is extracted from the base through a minimally invasive approach, allowing battery replacement without disturbing the anchoring structure embedded in the heart tissue. This extraction approach reduces surgical invasiveness.

Inventive Principle:
Principle #2Taking out (Extraction)

3Reliability

If the anchoring system is repositioned during capsule replacement, then the new capsule can be securely fixed, but heart function and blood flow are interfered with

Engineering Contradiction:
Improvecapsule fixationVSAvoidinterference with blood flow
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The anchoring system remains fixed in the base component, which is left implanted in the heart tissue. Only the capsule body is replaced, so the anchoring structure does not need to be repositioned, avoiding interference with heart function and blood flow while maintaining secure fixation.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The base with anchoring structure is implanted and secured in advance, establishing stable fixation before the capsule body is replaced. This preliminary anchoring action eliminates the need for repositioning during subsequent capsule replacements.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS9037262B2Autonomous intracardiac implantable medical device with releaseable base and fastener element
Publication Date: 2015.05.19 SORIN CRM
  • US9037262B2 patent drawing
  • US9037262B2 patent drawing
  • US9037262B2 patent drawing

AI summary

An intracorporeal autonomous active medical device having a capsule body and a base. The capsule body includes a body portion and a lid portion, and the capsule body contains therein electronic circuitry containing the active elements of the autonomous medical device, and a power supply. The capsule body also includes a fastening system on an exterior surface of the capsule body that is configured to correspond with a fastening mechanism on the base configured to be anchored to a tissue wall. The fastening mechanism provides selective engagement between the capsule body and the base.