Prefilled Syringe Gas-Actuated Delivery with Flow Restriction
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Solution Overview
Problem
Existing medicament delivery devices, particularly autoinjectors, face challenges in efficiently delivering high viscosity medicaments from prefilled syringes due to incompatible force and pressure requirements, leading to undesirable delivery conditions and potential damage to the medicament, as well as increased device size and complexity.
Innovation Solution
A medicament delivery device featuring a housing with an energy storage member that produces pressurized gas, a carrier, and a delivery control mechanism with a flow restriction member, which regulates pressure to ensure controlled delivery of medicaments with high viscosity, preventing shearing and minimizing pain, while maintaining a compact device design.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Extent of automation
If a spring-based actuation system is used to insert the needle and inject the medicament, then the needle insertion and medicament delivery can be automated, but the device size increases due to the need to incorporate the piston rod and the force requirements become incompatible with high viscosity medicaments
Solution Approach 1:
The patent removes the piston rod and mechanical linkage components from the autoinjector system. Instead of using a spring-based actuation system with a piston rod that moves through the device, the invention uses a simplified mechanism where the carrier itself moves to insert the needle and deliver the medicament, eliminating the need for separate actuation linkages and reducing overall device size.
Solution Approach 2:
The patent replaces the traditional spring-based mechanical actuation system with a different mechanical approach. Instead of using a spring that pushes a piston rod, the system uses a carrier that is moved directly by a simplified actuation mechanism, substituting the complex spring-piston system with a more compact direct-action system.
2Extent of automation
If high force is applied to overcome the resistance of spring-based actuation systems, then automated needle insertion can be achieved, but the force and pressure required are incompatible with the proper delivery of high viscosity medicaments
Solution Approach 1:
The patent implements a dynamic delivery system where the carrier can move at different speeds and the flow restriction member can adjust the medicament flow rate. This allows the system to apply higher force during needle insertion and then transition to a controlled, lower force delivery phase, making the system adaptable to both automated insertion and high viscosity medicament delivery requirements.
Solution Approach 2:
The flow restriction member acts as an intermediary between the high-force actuation system and the medicament delivery. It mediates the force application by restricting the flow of high viscosity medicament, allowing the system to generate the necessary force for automated insertion while preventing excessive force from damaging the medicament or causing pain during delivery.
3Productivity
If the rate of delivery is increased to improve productivity, then more medicament can be delivered faster, but the resulting shear forces may damage the molecules within the substance
Solution Approach 1:
The flow restriction member serves as a mediator that controls the relationship between delivery rate and shear force. By restricting the flow through a controlled opening, it allows the system to maintain an acceptable delivery rate while preventing excessive shear forces from damaging the medicament molecules, effectively decoupling the direct relationship between speed and damage.
Solution Approach 2:
The patent changes the physical parameters of the delivery system by introducing a flow restriction member that modifies the flow characteristics. This allows the system to operate at higher delivery rates while maintaining lower shear forces by changing the flow profile and pressure distribution, thus protecting the medicament integrity.
4Reliability
If known prefilled syringes with staked needles are used, then the needle remains sterile prior to use, but applying force to the plunger during storage or insertion can cause leakage of the medicament
Solution Approach 1:
The patent extracts the plunger from the syringe body, separating the two components. The carrier is configured to receive and hold the syringe body without requiring the plunger to be inserted or actuated during storage. This allows the syringe to remain sealed and sterile while the carrier provides the necessary actuation force during the injection event without causing premature plunger movement or medicament leakage.
Solution Approach 2:
The carrier is pre-configured with a receptacle that holds the syringe body in a ready position. The syringe is pre-loaded into the carrier with the needle exposed but the plunger not actuated. This preliminary arrangement allows the system to maintain sterility while being ready for immediate injection, eliminating the need to apply force to the plunger during storage or handling.
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 enables efficient and controlled delivery of high viscosity medicaments, preventing shearing and reducing patient discomfort, while maintaining a compact device size and avoiding the need for mechanical linkages, thus improving the efficacy and safety of medicament administration.
Implementation Method 1
an energy storage member that produces pressurized gas
Implementation Method 2
a delivery control mechanism with a flow restriction member, which regulates pressure to ensure controlled delivery of medicaments with high viscosity
Data Source
AI summary
An apparatus includes a housing, an energy storage member, a carrier, a medicament container, and a delivery control mechanism. The housing defines a gas chamber configured to receive pressurized gas from the energy storage member to pressurize the gas chamber. The carrier has a proximal surface that defines a portion of the gas chamber. The medicament container is coupled to the carrier and has a distal end portion coupled to a delivery member. The medicament container contains a medicament and includes an elastomeric member that seals the medicament within the medicament container. The delivery control mechanism is coupled to a proximal end portion of the medicament container and includes a flow restriction member for regulating a pressure supplied by the gas chamber and entering into the medicament container that acts on the elastomeric member.