Insertion Device Sleeve for Kink-Resistant Implant Placement

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Solution Overview

Problem

Existing insertion devices, such as catheters, face challenges in precisely positioning medical implants due to mechanical stresses that can lead to kinking and improper placement, especially in cases of calcification like aortic stenosis, making it difficult to release or retract implants accurately.

Innovation Solution

An insertion device with a locally placed sleeve that dampens mechanical stresses at the transition between the outer shaft and receiving element, using materials like thermoplastics or cold-shrink materials, such as PEEK, that can contract to prevent kinking and ensure reliable release and retraction of self-expanding stent systems or heart valve prostheses.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If the catheter is made flexible to allow curving and bending, then the ease of operation is improved, but the mechanical stability deteriorates leading to kinking

Engineering Contradiction:
Improveflexibility for curving and bendingVSAvoidmechanical stability against kinking
Core Design Contradiction:
Ease of operationVSStability of the object's composition

Solution Approach 1:

The patent applies a sleeve with different mechanical properties at a specific location (the transition zone between outer shaft and receiving element) rather than changing the properties of the entire catheter. This localized reinforcement provides kink protection exactly where the stress concentration occurs, while maintaining the overall flexibility of the catheter for navigation.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent combines two different materials: the flexible catheter material and the sleeve material (which may be more rigid or have different mechanical properties). This composite structure creates a region with enhanced mechanical stability at the transition zone while the rest of the catheter remains flexible for operation.

Inventive Principle:
Principle #40Composite materials

2Adaptability or versatility

If the catheter length is increased to reach distant implantation sites, then the adaptability is improved, but the mechanical load increases causing more kinking

Engineering Contradiction:
Improvereach to distant sitesVSAvoidmechanical load on catheter
Core Design Contradiction:
Adaptability or versatilityVSForce

Solution Approach 1:

The sleeve is placed specifically at the transition zone where mechanical stresses are most concentrated during implant retrieval. This localized reinforcement protects the critical junction point from kinking even when the catheter is subjected to high mechanical loads from retrieving implants from distant locations.

Inventive Principle:
Principle #3Local quality

3Stability of the object's composition

If the transition zone between outer shaft and receiving element is reinforced, then the stability is improved, but the device complexity increases

Engineering Contradiction:
Improvestability at transition zoneVSAvoidstructural complexity
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The sleeve acts as an intermediary element between the outer shaft and the receiving element. This simple intermediate component absorbs and distributes the mechanical stresses at the transition zone, preventing kinking without requiring complex structural modifications to either the shaft or the receiving element.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The sleeve is implemented as a thin-walled cylindrical structure that can be made from flexible materials. This thin-film approach provides the necessary mechanical reinforcement at the transition zone while adding minimal complexity and maintaining the overall simplicity of the catheter design.

Inventive Principle:
Principle #30Flexible shells and thin films

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 stabilizes the insertion device against kinking, enabling reliable and accurate placement and repositioning of medical implants, particularly for self-expanding stent systems and heart valve prostheses, while being cost-effective and easy to implement.

Implementation Method 1

The sleeve is preferably formed of a material that can be contracted selectively from a state that is widened based on an inner diameter of the sleeve into a shrunken state. Preferred materials include thermoplastics that contract when heated.

Methodology Applied
Scientific EffectThermal contraction: Thermal Contraction

Data Source

PatentUS11020562B2Insertion device for insertion of a medical implant
Publication Date: 2021.06.01 BIOTRONIK AG
  • US11020562B2 patent drawing
  • US11020562B2 patent drawing

AI summary

An insertion device for the insertion of a medical implant into a human and/or animal body. The device has at least one outer shaft, which has a proximal end and a distal end opposite the proximal end. A receiving element is connected to the outer shaft, for the implant. The outer shaft and the receiving element are surrounded at a transition between the outer shaft and receiving element by a locally placed sleeve, which dampens mechanical tensile and/or compressive stresses.