Dialyzer Leak Control Using Pump Rate and Pressure Reduction

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Solution Overview

Problem

Existing blood treatment devices face challenges in preventing excessive blood loss into the dialysate due to capillary breaks and associated leaks in the semi-permeable membrane during treatments like haemofiltration, haemodiafiltration, or ultrafiltration, despite conventional protection systems.

Innovation Solution

The device incorporates a blood pump, venous pressure sensor, blood leak detector, and interruption means, controlled by a regulation unit to manage the blood and dialysate pumps, transitioning to a further operating mode to reduce the transmembrane pressure gradient and activate interruption means to prevent further blood flow into the dialysate chamber.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional protection systems with blood leak detectors are used, then patient safety is improved through detection of blood leaks, but blood loss into the dialysate cannot be prevented once a leak occurs

Engineering Contradiction:
Improvepatient safetyVSAvoidblood loss into dialysate
Core Design Contradiction:
ReliabilityVSLoss of substance

Solution Approach 1:

The control unit initiates corrective actions (reducing blood pump conveyance rate, activating interruption means) immediately upon detecting a blood leak, before significant blood loss occurs. This preliminary response prevents the worsening of the situation rather than merely detecting it.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The blood leak detector provides continuous feedback to the control unit about the presence of blood in the dialysate circuit. The control unit uses this feedback to dynamically adjust the blood pump conveyance rate and activate interruption means, creating a closed-loop control system that actively prevents blood loss.

Inventive Principle:
Principle #23Feedback

2Loss of substance

If the blood pump is stopped immediately upon blood leak detection, then blood loss is reduced, but pressure buildup may cause additional membrane rupture

Engineering Contradiction:
Improveblood loss reductionVSAvoidpressure buildup
Core Design Contradiction:
Loss of substanceVSObject-affected harmful factors

Solution Approach 1:

Instead of an abrupt stop, the blood pump conveyance rate is dynamically reduced in a controlled manner. The control unit adjusts the pump speed gradually, allowing pressure to equalize without sudden changes that could cause additional membrane rupture, while still preventing blood loss.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The control unit changes the operational parameters of the blood pump by reducing the conveyance rate rather than completely stopping it. This parameter adjustment maintains a balance between preventing blood loss and avoiding dangerous pressure buildup that could worsen the membrane rupture.

Inventive Principle:
Principle #35Parameter changes

3Loss of substance

If interruption means are activated immediately, then blood flow into dialysate is blocked, but pressure gradient may persist causing continued leakage

Engineering Contradiction:
Improveblood flow blockingVSAvoidtransmembrane pressure gradient
Core Design Contradiction:
Loss of substanceVSStress or pressure

Solution Approach 1:

The control unit reduces the blood pump conveyance rate before activating the interruption means. This preliminary action reduces the pressure gradient across the membrane, so that when the interruption means are activated, continued leakage is minimized.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system maintains continuous monitoring and control of the transmembrane pressure gradient throughout the blood treatment. Even after activation of interruption means, the control unit continues to adjust the blood pump conveyance rate to maintain an optimal pressure gradient, preventing further leakage while keeping the system in a controlled state.

Inventive Principle:
Principle #20Continuity of useful action

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 approach effectively minimizes blood loss by rapidly reducing the transmembrane pressure gradient and blocking fluid flow, ensuring patient safety by preventing increased blood leakage into the dialysate.

Implementation Method 1

a blood filter, which can be in the form of a dialyser (200), said dialyser having a semi-permeable membrane (200c) which separates a dialysate chamber (200b) and blood chamber (200a) present in the blood filter (200)

Methodology Applied
Scientific EffectSemipermeable membrane separation: Semipermeable Membrane

Implementation Method 2

a blood pump (4) for conveying blood through the extracorporeal blood circuit (400)

Methodology Applied
Scientific EffectPump: Pump

Implementation Method 3

at least one venous pressure sensor (10) for the extracorporeal blood circuit (400)

Methodology Applied
Scientific EffectPressure sensing:

Implementation Method 4

a blood leak detector (23) on its hydraulic side... flow-through operation of the blood leak detector thus being carried out

Methodology Applied
Scientific EffectBlood detection:

Data Source

PatentUS20250339592A1Blood treatment device
Publication Date: 2025.11.06 FRESENIUS MEDICAL CARE AG
  • US20250339592A1 patent drawing
  • US20250339592A1 patent drawing

AI summary

The invention relates to a blood treatment device 100 comprising or connected to, in each case, at least one extracorporeal blood circuit 400, one pressure sensor 10 for measuring a prevailing fluid pressure in the extracorporeal blood circuit 400, one blood pump 4 for conveying blood through the extracorporeal blood circuit 400, one dialysate circuit 500, one blood leak detector 23 for sensing an escape of blood in the dialysate circuit 500, one blood filter 200, comprising a dialysate chamber 200b, a blood chamber 200a and a semi-permeable membrane 200c separating the two chambers. Moreover comprising at least one interruption means, one control or regulation unit 60, wherein the control or regulation unit 60 is designed to operate the blood pump 4 in a first operating mode and, after detection of a triggering event, to transfer it into a further operating mode in which a conveyance rate of the blood pump 4 is controlled on the basis of a preset or regulated to a target value. Furthermore, the control or regulation unit 60 is designed to activate the interruption means.