Multi-orifice Insulin Catheter with Vibration for Absorption

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Solution Overview

Problem

Current continuous subcutaneous insulin infusion (CSII) catheters experience slow, variable, and unreliable insulin absorption due to tissue damage, inflammation, and heterogeneous subcutaneous tissue composition, leading to inefficient insulin delivery and frequent site changes.

Innovation Solution

A CSII catheter with an elongate flexible cannula featuring multiple holes along its length, atraumatic needle tip, and vibration mechanism to enhance insulin distribution and absorption, minimizing tissue trauma and promoting prolonged, precise insulin delivery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If a single distal orifice catheter is used, then the device is simple to manufacture, but insulin absorption becomes slow and variable after 2-3 days due to tissue damage and inflammation

Engineering Contradiction:
Improvecatheter manufacturing simplicityVSAvoidinsulin absorption reliability
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The catheter is divided into multiple segments along its length, with multiple orifices distributed axially and circumferentially. This segmentation allows insulin to be delivered to multiple locations simultaneously, increasing the effective surface area for absorption and reducing dependence on a single distal tip location that becomes compromised by inflammation.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention transitions from a single-point (0D) orifice at the distal tip to a distributed array of orifices across multiple dimensions (1D axial distribution and 2D circumferential distribution). This multi-dimensional distribution of insulin delivery points ensures that even if some orifices are affected by tissue inflammation, others remain functional for reliable absorption.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

2Stress or pressure

If rapid insulin bolus infusion is used, then the pressure differential increases to overcome tissue resistance, but the surrounding inflammatory tissue distends and creates back-pressure reducing absorption efficiency

Engineering Contradiction:
Improvepressure differential for insulin flowVSAvoidinsulin absorption rate
Core Design Contradiction:
Stress or pressureVSReliability

Solution Approach 1:

The total insulin bolus volume is distributed across multiple orifices along the catheter length. Each orifice delivers a portion of the bolus to a different location in the subcutaneous tissue, preventing excessive distension of any single tissue compartment and reducing localized back-pressure that would impede absorption.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

By distributing insulin delivery across multiple spatial dimensions (axial and circumferential), the invention expands the volume of tissue exposed to insulin without concentrating pressure in one location. This multi-dimensional distribution allows rapid bolus infusion to overcome tissue resistance while avoiding the formation of a single large insulin pool that would distend tissue and create back-pressure.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

3Duration of action of stationary object

If the cannula remains in subcutaneous tissue for extended periods, then site changes are reduced, but the layer of inflammatory tissue becomes thicker and denser creating a mechanical barrier to insulin absorption

Engineering Contradiction:
Improvecatheter retention timeVSAvoidinflammatory tissue barrier
Core Design Contradiction:
Duration of action of stationary objectVSObject-affected harmful factors

Solution Approach 1:

Multiple orifices distributed along the catheter length ensure that insulin can be delivered through multiple pathways. Even as inflammatory tissue forms around the catheter, some orifices remain accessible to functional capillary and lymphatic vessels, maintaining absorption capability throughout the catheter's retention period.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The distributed orifice arrangement in multiple dimensions allows insulin to reach absorptive vessels at various distances and orientations from the catheter. This multi-dimensional delivery strategy ensures that as inflammatory tissue thickens, insulin can still reach functional vessels through multiple pathways, maintaining reliable absorption for extended periods.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

4Device complexity

If insulin is delivered into a single location, then the catheter structure is simple, but the surface area of insulin in contact with capillaries and lymph vessels is limited reducing absorption rate

Engineering Contradiction:
Improvecatheter structural complexityVSAvoidinsulin absorption rate
Core Design Contradiction:
Device complexityVSProductivity

Solution Approach 1:

The catheter is segmented into multiple orifices distributed along its length, creating multiple insulin delivery locations. This segmentation increases the total surface area of insulin contact with absorptive vessels without requiring complex external delivery mechanisms, achieving enhanced absorption through distributed multi-point delivery.

Inventive Principle:
Principle #1Segmentation

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 catheter design increases the rate and precision of insulin absorption into the circulation for an extended period, reducing the need for frequent site changes and improving blood glucose control.

Implementation Method 1

The insulin pump produces a hydrostatic pressure differential between the inside of the CSII catheter and the outside of the CSII catheter and the surrounding tissue

Methodology Applied
Scientific EffectHydrostatic pressure differential: Pressure Gradient

Implementation Method 2

A CSII catheter with an elongate flexible cannula featuring multiple holes along its length, atraumatic needle tip, and vibration mechanism to enhance insulin distribution and absorption

Methodology Applied
Scientific EffectMechanical vibration: Vibration

Data Source

PatentEP3352814B1Continuous subcutaneous insulin infusion catheter
Publication Date: 2024.04.10 THOMAS JEFFERSON UNIV
  • EP3352814B1 patent drawingFigure 1~2
  • EP3352814B1 patent drawingFigure 3~4
  • EP3352814B1 patent drawingFigure 5A~5C

AI summary

A continuous subcutaneous infusion catheter includes an elongate flexible cannula and a plurality of holes through the cannula wall that are positioned both along the axial length of the cannula and radially around the cannula. The proximal end of the cannula is configured to be attached to a pump, and the distal end of the flexible cannula is atraumatic. The catheter can be used to deliver insulin to a patient.