Seal Plug with Frustoconical Geometry for Implantable Pulse Generators

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Solution Overview

Problem

There is a need for alternative designs for housings, headers, and associated seal plugs for implantable medical devices that can effectively isolate internal components from conductive bodily fluids while maintaining reliability and reducing assembly time and costs.

Innovation Solution

The design includes a pulse generator with a header that features a core assembly and a seal plug positioned in a set screw hole, where the seal plug has a frustoconical portion and a deformable slit for sealing, and is retained without medical adhesive, allowing for easy insertion and removal of tools to seal and unseal fluid flow.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional seal plugs are used with medical adhesive, then sealing reliability is improved, but assembly complexity and manufacturing cost increase

Engineering Contradiction:
Improvesealing reliabilityVSAvoidassembly complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The invention removes the medical adhesive component from the sealing system, extracting the dependency on adhesives and replacing it with a purely mechanical sealing mechanism using the frustoconical seal plug geometry

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The seal plug's frustoconical geometry enables self-retention and self-sealing within the matching frustoconical hole, allowing the component to secure itself without external adhesives or additional fastening elements

Inventive Principle:
Principle #25Self-service

2Reliability

If traditional seal plugs require medical adhesive, then sealing reliability is improved, but manufacturing cost increases

Engineering Contradiction:
Improvesealing reliabilityVSAvoidmanufacturing cost
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The invention removes the medical adhesive component from the sealing system, extracting the dependency on adhesives and replacing it with a purely mechanical sealing mechanism using the frustoconical seal plug geometry

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The seal plug is designed as a simple, inexpensive component that can be easily manufactured and replaced if necessary, eliminating the need for expensive medical adhesives and associated quality control processes

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

3Reliability

If seal plugs are designed for permanent sealing, then sealing reliability is improved, but operational flexibility decreases

Engineering Contradiction:
Improvesealing reliabilityVSAvoidoperational flexibility
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The seal plug transitions from a static permanent seal to a dynamic reversible seal, allowing it to be inserted for sealing and removed or repositioned when operational flexibility is needed, while maintaining reliable sealing when engaged

Inventive Principle:
Principle #15Dynamics

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 design effectively seals the header from bodily fluids, reduces the reliance on medical adhesives, and simplifies the assembly process, enhancing the reliability and cost-effectiveness of implantable medical devices.

Implementation Method 1

the seal plug has a deformable slit extending through the top of the seal plug through which a tool can be inserted and that is substantially closed to seal and limit fluid flow through the seal plug when the tool is removed

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 2

the seal plug has a substantially frustoconical portion from the plug inner portion to the plug outer portion

Methodology Applied
Scientific EffectGeometry-based sealing: Geometry

Data Source

PatentUS9511235B2Seal plug
Publication Date: 2016.12.06 CARDIAC PACEMAKERS INC
  • US9511235B2 patent drawing
  • US9511235B2 patent drawing
  • US9511235B2 patent drawing

AI summary

An implantable pulse generator includes a core assembly, a seal plug, and an outer layer overmolded over the core assembly adjacent the seal plug. The core assembly defines a core hole extending through the core assembly from a core interior to a core outer surface. The core hole has a hole outer portion and a hole inner portion. A first diameter of the hole outer portion is less than a second diameter of the hole inner portion. The seal plug is positioned in the core hole and has a plug outer portion aligned with the hole outer portion and a plug inner portion aligned with the hole inner portion. A third diameter of the plug outer portion is less than a fourth diameter of the plug inner portion. The outer layer leaves a top of the seal plug exposed.