Buffer Cartridge Sterilization Pressure Control

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Solution Overview

Problem

Commercially available sodium bicarbonate buffer solutions do not provide precisely controlled pH, leading to inconsistent pH levels in medical solutions during sterilization, which affects the efficacy and safety of medical procedures.

Innovation Solution

Applying external pressure to medical solution containers during heat sterilization to inhibit boiling and irreversible carbon dioxide bubble formation, while maintaining pressure below a threshold to prevent crystallization, using trays with compression members to apply consistent pressure to cartridges filled with sodium bicarbonate buffers.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If heat sterilization is applied to buffer solution cartridges, then sterilization is achieved, but pH instability and carbon dioxide bubble formation occur

Engineering Contradiction:
Improvesterilization effectivenessVSAvoidpH stability
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent applies preliminary anti-action by pre-compressing the buffer solution in the cartridge before sterilization to prevent carbon dioxide evolution and pH instability. The compression force counteracts the tendency of CO2 to escape during heating, thereby preventing the harmful effect before it occurs.

Inventive Principle:
Principle #9Preliminary anti-action

Solution Approach 2:

The patent changes the pressure parameter of the buffer solution during sterilization. By maintaining elevated pressure on the solution throughout the sterilization process, the boiling point of the buffer is raised and carbon dioxide remains dissolved, preventing bubble formation and pH instability while still allowing effective sterilization.

Inventive Principle:
Principle #35Parameter changes

2Stability of the object's composition

If pressure is applied to prevent boiling during sterilization, then pH stability is improved, but crystallization may occur if pressure is too high

Engineering Contradiction:
ImprovepH stabilityVSAvoidcrystallization risk
Core Design Contradiction:
Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The patent employs a dynamic compression spring that automatically adjusts the pressure applied to the buffer solution. The spring provides sufficient compression to prevent boiling and maintain pH stability during sterilization, but the pressure is not excessive to cause crystallization. The dynamic nature of the spring allows it to adapt to the changing conditions during the sterilization process.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The compression spring acts as an intermediary mechanism between the sterilization process and the buffer solution. It transmits just the right amount of pressure to prevent boiling without applying excessive force that would cause crystallization, thereby mediating between the conflicting requirements of pH stability and preventing harmful crystallization.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Ease of manufacture

If commercial buffer solutions are used, then availability is improved, but pH control precision deteriorates

Engineering Contradiction:
Improvebuffer availabilityVSAvoidpH control precision
Core Design Contradiction:
Ease of manufactureVSManufacturing precision

Solution Approach 1:

The patent performs preliminary action by pre-adjusting the pH of the buffer solution during the manufacturing process and sealing it in cartridges under controlled conditions. This preliminary pH adjustment ensures that the buffer has the precise desired pH before sterilization, and the subsequent compression during sterilization maintains this precision by preventing CO2 loss.

Inventive Principle:
Principle #10Preliminary 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

Prevents pH instability and crystallization of buffer solutions, ensuring consistent pH levels and maintaining the integrity of medical solutions during sterilization and storage, allowing for precise control of buffered anesthetic solutions.

Implementation Method 1

a force is applied to the solution in the container... sufficient to create pressure in the solution that inhibits boiling the water contained in the medical solution

Methodology Applied
Scientific EffectPressure increase: Pressure Increase

Implementation Method 2

The container is exposed to an elevated temperature sufficient to sterilize the container and the medical solution

Methodology Applied
Scientific EffectHeating: Heating

Implementation Method 3

the spring must be soft enough to absorb the thermal expansion of the solution without which absorption, the container may shatter

Methodology Applied
Scientific EffectThermal expansion: Thermal Expansion

Data Source

PatentUS8900513B2Methods and devices for sterilizing and holding buffering solution cartridges
Publication Date: 2014.12.02 ONPHARMA INC
  • US8900513B2 patent drawing
  • US8900513B2 patent drawing
  • US8900513B2 patent drawing

AI summary

Trays comprising a base have a plurality of axial slots adapted to receive buffer or other medical solution containers within the slots. A spring or other compression element at the bottom of the slot is configured to engage a plunger at the bottom of the solution container when present in the slot so that pressure is applied to the contents of the container in order to stabilize the contents while the containers are sterilized at an elevated temperature.