Localized Therapy Delivery via Circulatory Isolation

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Current therapy delivery methods often result in systemic side effects and inefficiencies due to dilution of treatments through systemic circulation, limiting the effectiveness of localized treatments for conditions like ischemic injuries and tumors, as conventional methods fail to maintain a high organ-to-body concentration gradient and isolate the target tissue effectively.

Innovation Solution

A system that isolates organ circulation from systemic circulation using catheters with occlusion devices and an extracorporeal blood conditioning apparatus to deliver therapy directly to the target tissue, minimizing systemic impact and maintaining a high therapeutic gradient through antegrade or retrograde flow, and includes therapy deactivation to prevent systemic effects.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If systemic administration of therapy is used, then accessibility and ease of delivery are improved, but therapy effectiveness is reduced due to dilution and systemic side effects

Engineering Contradiction:
Improveease of deliveryVSAvoidtherapy effectiveness
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent divides the circulatory system into isolated segments using occlusion devices (balloons) to create a localized treatment zone. By inflating occlusion devices in veins or arteries, the treatment area is segmented from the rest of the systemic circulation, allowing concentrated therapy delivery to specific tissues without systemic dilution.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent applies local quality by creating a unique therapeutic environment in the target tissue region through circulation isolation. The isolated zone receives high-concentration therapy while maintaining different physiological conditions compared to the rest of the body, enabling localized treatment effectiveness without systemic side effects.

Inventive Principle:
Principle #3Local quality

2Quantity of substance

If localized administration of therapy is used, then therapy concentration at target site is improved, but systemic circulation still causes dilution and side effects

Engineering Contradiction:
Improvetherapy concentrationVSAvoidsystemic side effects
Core Design Contradiction:
Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The patent extracts the target tissue circulation from the systemic circulation using occlusion devices. By isolating the arterial inflow or venous drainage of the target organ, the therapy-containing circulation is taken out of the systemic pathway, preventing therapy dilution and elimination of harmful systemic effects while maintaining high local concentration.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The occlusion devices serve as intermediaries between the systemic circulation and the isolated treatment zone. These devices create a controlled interface that allows selective isolation of target tissue circulation, enabling high-concentration therapy delivery while blocking the pathway that would otherwise cause systemic distribution and side effects.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If conventional total-body cooling is used for tissue protection, then tissue damage prevention is improved, but systemic adverse effects worsen

Engineering Contradiction:
Improvetissue protection effectivenessVSAvoidsystemic adverse effects
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies local quality by cooling only the isolated target tissue circulation rather than the entire body. The occlusion devices enable creation of a localized cold zone in the target organ while the rest of the body maintains normal temperature, providing tissue protection without systemic cooling side effects such as shivering, electrolyte shifts, or coagulopathy.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent segments the body's thermal regulation by isolating the target tissue circulation from systemic circulation using occlusion devices. This allows independent temperature control of the target organ, enabling localized therapeutic cooling for tissue protection while preventing systemic adverse effects associated with total-body cooling.

Inventive Principle:
Principle #1Segmentation

4Reliability

If aggressive therapy is administered to achieve maximum treatment benefit, then treatment effectiveness is improved, but systemic toxicity increases

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidsystemic toxicity
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent extracts the aggressive therapy from the systemic circulation pathway by isolating the target tissue circulation with occlusion devices. This allows administration of high-dose or aggressive therapies (such as chemotherapy or therapeutic hypothermia) directly to the isolated target zone without systemic distribution, achieving maximum treatment benefit while eliminating systemic toxicity.

Inventive Principle:
Principle #2Taking out (Extraction)

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

Enables localized and isolated delivery of aggressive treatments like therapeutic hypothermia and chemotherapy, reducing systemic side effects and enhancing treatment potency by maintaining a high organ-to-systemic concentration gradient, thereby expanding the use of existing treatments for more patients.

Implementation Method 1

a distal portion of the catheter includes an occlusion device adapted to selectively substantially occlude the venous drainage structure

Methodology Applied
Scientific EffectOcclusion:

Implementation Method 2

a perfusion port operably disposed upstream from the occlusion device for delivering a perfusate to the at least partially isolated organ circulation

Methodology Applied
Scientific EffectFluid flow:

Implementation Method 3

a blood conditioning apparatus capable of conditioning a blood supply for perfusion through the perfusion line

Methodology Applied
Scientific EffectHeat exchange: Heat Exchanger

Implementation Method 4

and includes therapy deactivation to prevent systemic effects

Methodology Applied
Scientific EffectTherapy deactivation:

Data Source

PatentEP3620202B1Localized therapy delivery and local organ protection
Publication Date: 2023.06.14 NIRVA MEDICAL
  • EP3620202B1 patent drawingFigure 1
  • EP3620202B1 patent drawingFigure 2
  • EP3620202B1 patent drawingFigure 3

AI summary

A system for perfusing a localized site within a body includes a catheter assembly having a venous access line that is adapted to deliver perfusate to the localized site, a venous or arterial drainage line adapted to drain perfusate from the localized site, and an occlusion device adapted to prevent some or substantially all physiological blood flow between the localized site and the systemic circulation of the body during and in the course of perfusing and draining perfusate to and from the localized site. The system may include a blood circuit associated with the catheter assembly to facilitate blood conditioning for use as the perfusate, in the course of a controlled perfusion and/or drainage of untreated, treated, or inactivated treated blood to and from the localized site. A delivery machine may control the blood circuit and catheter assembly in order to both deliver perfusate to, and drain some or all perfusate from, the localized site in a manner that provides perfusate to substantially only the localized site.