Osmotic Piston Assembly Sealing Against Organic Solvent Leaching

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Solution Overview

Problem

Existing osmotic delivery systems face challenges in maintaining compatibility and sealing of pistons with components, particularly when exposed to organic solvents, leading to leaching issues that affect the integrity and performance of the system.

Innovation Solution

The development of a piston assembly with a body made from polymeric materials resistant to leaching in organic solvents, featuring a columnar design with a rim and spring mechanism for sealing, and the use of elastomeric O-rings to ensure a reliable seal within the osmotic delivery system.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional elastomeric materials are used for the piston, then the piston can deform to fit the lumen and provide sealing, but the piston becomes incompatible with organic solvents and exhibits leaching

Engineering Contradiction:
Improvesealing compatibilityVSAvoidleaching in organic solvents
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The piston is constructed from a composite material system consisting of a polymeric body (such as polyolefin, polyethylene, or polypropylene) combined with elastomeric sealing components (O-rings, gaskets, or lips). This composite approach allows the main body to resist organic solvent leaching while the elastomeric sealing elements provide the necessary deformation and sealing capability against the reservoir wall.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

Different portions of the piston are made from materials with different properties: the main body uses solvent-resistant polymeric material for structural integrity and chemical compatibility, while localized sealing portions use elastomeric materials that can deform to create tight seals. This local differentiation of material properties resolves the contradiction between chemical resistance and sealing capability.

Inventive Principle:
Principle #3Local quality

2Reliability

If the piston material is made softer to improve sealing against the reservoir wall, then sealing improves, but the piston becomes more susceptible to degradation in organic solvents

Engineering Contradiction:
Improvesealing performanceVSAvoidmaterial stability in organic solvents
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The piston combines soft elastomeric sealing elements with a harder, chemically resistant polymeric body. The elastomeric portions (O-rings, lips, or gaskets) provide the softness needed for sealing against the reservoir wall, while the polymeric body maintains dimensional stability and resistance to organic solvent degradation.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The piston structure differentiates between sealing surfaces and structural portions, using softer elastomeric materials only where contact with the reservoir wall is required for sealing, while the bulk of the piston uses harder, more chemically stable polymeric material that resists solvent degradation.

Inventive Principle:
Principle #3Local quality

3Strength

If a rigid material is used for the piston body to maintain structural integrity, then strength improves, but the piston cannot deform to fit the lumen for proper sealing

Engineering Contradiction:
Improvestructural integrityVSAvoidsealing capability
Core Design Contradiction:
StrengthVSReliability

Solution Approach 1:

The piston uses a composite construction where a rigid or semi-rigid polymeric body provides structural integrity and strength, while flexible elastomeric sealing components (such as O-rings, lips, or gaskets) are integrated to provide the deformation capability needed for sealing against the reservoir wall.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The piston structure assigns different mechanical properties to different regions: the main body uses rigid polymeric material for strength and structural support, while localized sealing portions use flexible elastomeric material that can deform to conform to the reservoir wall and create effective seals.

Inventive Principle:
Principle #3Local quality

4Reliability

If elastomeric materials are used for the piston, then sealing against the wall is improved, but leaching occurs when exposed to organic solvents

Engineering Contradiction:
Improvesealing effectivenessVSAvoidleaching into the system
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The piston combines elastomeric sealing elements with polymeric body material. The elastomeric components (O-rings, gaskets, lips) provide effective sealing against the reservoir wall, while the polymeric body material (such as polyolefin, polyethylene, or polypropylene) resists leaching when exposed to organic solvents, preventing contamination of the active agent formulation.

Inventive Principle:
Principle #40Composite materials

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 solution provides a reliable, long-lasting seal and prevents leaching, ensuring the integrity and effectiveness of the osmotic delivery system, even when exposed to organic solvents, thereby maintaining consistent and controlled release of active agents.

Implementation Method 1

a spring (e.g., a radial spring, such as a canted coil spring) retained in a cavity for biasing the rim against the wall of the reservoir

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 2

The body is typically made of material that is resistant to leaching in an organic solvent, for example, a polymeric material

Methodology Applied
Scientific EffectPermeation resistance: Permeation

Implementation Method 3

The first chamber contains an osmotic agent formulation while the second chamber contains an active agent formulation. Pressure differential across the piston allows the piston to move longitudinally within the reservoir

Methodology Applied
Scientific EffectOsmotic pressure: Osmotic Pressure

Data Source

PatentUS10527170B2Osmotic delivery systems and piston assemblies for use therein
Publication Date: 2020.01.07 INTARCIA THERAPEUTICS INC
  • US10527170B2 patent drawing
  • US10527170B2 patent drawing
  • US10527170B2 patent drawing

AI summary

An osmotic delivery system is disclosed for delivering an active agent formulation to a fluid environment. The osmotic delivery system typically comprises a reservoir having a lumen that contains the active agent formulation and an osmotic agent formulation and a piston assembly positioned in the lumen to isolate the active agent formulation from the osmotic agent formulation. The piston assembly typically comprises a body constructed and arranged for positioning in the lumen. The body is typically made of a polymeric material that is, for example, resistant to leaching in an organic solvent. In one embodiment, the body is a columnar body having a rim at a distal end thereof for engaging and sealing against a wall of the reservoir and the piston assembly further comprises a spring retained at the distal end of the columnar body for biasing the rim of the columnar body against the wall of the reservoir.