Implantable Vascular Access Device with Funnelling Channels

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Solution Overview

Problem

Current haemodialysis methods using arteriovenous fistulas are plagued by patient discomfort, risk of infection, need for specialized personnel, and prolonged treatment times due to the use of sharp needles and complex vascular access devices that require frequent operations and are costly.

Innovation Solution

A vascular access device that is permanently implantable, allowing for hydraulic connection between veins and arteries, using a single-use cannula system that reduces needle insertion trauma and allows for easier access with a non-cutting cannula, enabling simpler and more efficient haemodialysis procedures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If sharp fistula needles are used for frequent insertion into the arteriovenous fistula, then blood collection and injection can be achieved, but patient discomfort, pain, and trauma to the FAV wall increase significantly

Engineering Contradiction:
Improveblood collection efficiencyVSAvoidpatient discomfort and trauma
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The device divides the vascular access function into two separate components: a permanent implantable device with funnelling channels that remains in the FAV, and a removable collection/injection device that connects to it. This segmentation allows the permanent device to handle the trauma of frequent needle insertions while the removable device provides comfortable access for blood collection and injection.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The funnelling channels are pre-formed in the permanent device during a single surgical implantation procedure. This preliminary action creates ready-made access pathways that eliminate the need for repeated sharp needle insertions into the FAV wall during subsequent haemodialysis sessions, thereby reducing patient trauma and discomfort.

Inventive Principle:
Principle #10Preliminary action

2Manufacturing precision

If the funnelling channel device is used to guide fistula needles, then insertion points are standardized, but the risk of crossing the vein from side to side and damage to the FAV remains

Engineering Contradiction:
Improveneedle insertion precisionVSAvoidFAV integrity
Core Design Contradiction:
Manufacturing precisionVSReliability

Solution Approach 1:

Instead of guiding sharp needles through the FAV wall (traditional approach), the invention inverts the approach by having the cannula with non-cutting tip pass through the permanent device's funnelling channels. The cannula enters from the opposite direction and connects to the internal lumen, eliminating the risk of FAV wall damage while maintaining precise insertion.

Inventive Principle:
Principle #13The other way round (Inversion)

Solution Approach 2:

The permanent device with funnelling channels acts as an intermediary between the external cannula and the FAV lumen. It provides a protected pathway that guides the cannula safely into the vessel without exposing the FAV wall to direct needle trauma, thereby maintaining vessel integrity while enabling precise access.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Productivity

If metal fistula needles with cutting tips are used, then blood flow access is achieved, but the risk of infection and complications in patients with vein fragility increases

Engineering Contradiction:
Improveblood flow accessVSAvoidinfection risk
Core Design Contradiction:
ProductivityVSObject-generated harmful factors

Solution Approach 1:

The invention changes the critical parameter of the access device from a sharp metal needle with cutting tip to a cannula with a non-cutting tip. This parameter change eliminates the cutting action that causes trauma and infection risk, while the cannula's flexibility and the funnelling channel design maintain effective blood flow access.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The collection and injection device with the cannula is designed as a disposable single-use component that connects to the permanent implantable device. This disposable design eliminates the need for repeated sterilization and handling of sharp needles, thereby reducing infection risk while maintaining blood flow access efficiency.

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

4Object-affected harmful factors

If the Buttonhole method is used to create subcutaneous channels, then needle insertion trauma is reduced, but specialized personnel and complex procedures are required

Engineering Contradiction:
Improveinsertion traumaVSAvoidprocedure complexity
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The permanent device with funnelling channels is implanted during a single surgical procedure, performing the complex channel-creation action in advance. This preliminary action eliminates the need for repeated specialized procedures to create Buttonhole channels, as the funnelling channels are pre-formed and ready for simple cannula insertion during routine haemodialysis sessions.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentEP3986502B1Implantable vascular access device
Publication Date: 2024.10.16 EMODIAL
  • EP3986502B1 patent drawingFigure 1A~1E
  • EP3986502B1 patent drawingFigure 2A~4
  • EP3986502B1 patent drawingFigure 5

AI summary

The invention relates to a vascular access device for haemodialysis permanently implantable in a patient having a pre-existing arteriovenous fistula or, alternatively, in a vein, an artery or between a vein and an artery, to create an artificial arteriovenous fistula and a vascular access healing device and a sterile package containing a single-use device of collecting and/or injecting blood usable in combination with the vascular access device.