Handheld Drug Delivery Device Nested Drive Mechanism

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Solution Overview

Problem

Traditional drug delivery methods, such as syringes and auto-injectors, are limited in volume and control, compromising patient convenience and mobility, and often require larger doses or simplistic flow rates, while transdermal patches have restricted molecular drug structures and limited administration control.

Innovation Solution

A handheld drug delivery device with a drive mechanism, needle insertion mechanism, and fluid pathway connector, allowing for controlled delivery of larger volumes with reduced variability, ease of use, and compatibility for patients with reduced dexterity, featuring a compact design and ergonomic form factor.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If traditional syringes and auto-injectors are used for parenteral drug delivery, then the device structure is simple and ease of manufacture is improved, but the deliverable volume is limited and device complexity must be increased to achieve larger volumes

Engineering Contradiction:
Improvedeliverable volumeVSAvoiddevice complexity
Core Design Contradiction:
Quantity of substanceVSDevice complexity

Solution Approach 1:

The patent employs a nested structure where the piston is disposed inside the barrel, the plunger seal is inside the piston, and the drive mechanism components are integrated within the same housing. This nesting arrangement allows larger volume delivery capability while maintaining a compact form factor and avoiding excessive device complexity by efficiently utilizing internal space.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The device is segmented into distinct functional modules: a barrel for drug storage, a piston for volume displacement, a plunger seal for fluid sealing, and a drive mechanism for actuation. Each component is independently designed and assembled, allowing the system to achieve larger deliverable volumes through modular scalability without proportionally increasing overall device complexity.

Inventive Principle:
Principle #1Segmentation

2Measurement precision

If manual syringes are used for drug delivery, then the device structure is simple, but the delivery control precision and variability reduction are insufficient

Engineering Contradiction:
Improvedelivery control precisionVSAvoiddevice complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent incorporates a drive mechanism with a piston and plunger seal system that provides mechanical feedback control. The plunger seal engages with the piston to precisely control fluid displacement, and the drive mechanism includes features that provide tactile feedback to the user during actuation, enabling precise delivery control without requiring complex electronic systems.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The device is pre-assembled with the piston, plunger seal, and drive mechanism components positioned in their initial states before use. The pierceable seal is pre-positioned at the distal end of the barrel, and the activation mechanism is pre-configured to initiate the sequence of operations, reducing variability by ensuring consistent starting conditions for each delivery.

Inventive Principle:
Principle #10Preliminary action

3Extent of automation

If auto-injectors with syringe type containers are used, then the device is automated, but the total volume of drug is limited and maximum delivery force is restricted to avoid container breakage

Engineering Contradiction:
Improveautomation levelVSAvoidtotal volume of drug
Core Design Contradiction:
Extent of automationVSQuantity of substance

Solution Approach 1:

The patent employs a cylindrical barrel design with a curved pierceable seal at the distal end. This curved geometry distributes the delivery force more evenly across the seal surface during piston advancement, preventing stress concentration and container breakage while enabling higher delivery forces and larger drug volumes to be safely delivered through the automated mechanism.

Inventive Principle:
Principle #14Spheroidality (Curvature)

Solution Approach 2:

The barrel is designed with material properties that combine strength and flexibility, allowing it to withstand the forces generated by the drive mechanism during high-volume delivery. The composite construction of the barrel and pierceable seal enables the device to maintain structural integrity while delivering larger volumes through automated actuation.

Inventive Principle:
Principle #40Composite materials

4Ease of operation

If gravity-driven dispensers are used for continuous delivery, then the system is simple to operate, but patient mobility is compromised and flow rate control is limited to simplistic profiles

Engineering Contradiction:
Improveease of useVSAvoidflow rate control adaptability
Core Design Contradiction:
Ease of operationVSAdaptability or versatility

Solution Approach 1:

The patent employs a dynamic drive mechanism that can adjust the rate of piston advancement to achieve different flow rates and delivery profiles. The activation mechanism can be actuated at different speeds and with different force profiles, enabling adaptable flow rate control while maintaining ease of operation through a single activation action. The device can deliver the entire volume or portion thereof at controlled rates.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The device is designed to be self-contained with all delivery control mechanisms integrated into the single-unit structure. The drive mechanism automatically translates activation input into controlled piston movement and drug delivery without requiring external power sources or complex electronic controls, maintaining ease of operation while providing adaptable flow rate profiles through mechanical design.

Inventive Principle:
Principle #25Self-service

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 efficient and controlled delivery of larger drug volumes with reduced pain and improved user experience, particularly for patients with mobility or dexterity issues, while maintaining a compact and user-friendly design.

Implementation Method 1

the biasing member of the drive mechanism is configured to apply a force on the plunger seal in response to actuation of the activation mechanism, the force directed toward a distal end of the drug container

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 2

the drug container is configured to translate in the distal direction in response to the force applied to the plunger seal

Methodology Applied
Scientific EffectForce: Force

Implementation Method 3

displacement of the drug container causes the piercing member of the fluid pathway connector to pierce the pierceable seal to open a fluid pathway from the drug container

Methodology Applied
Scientific EffectMechanical Force: Mechanical Force

Implementation Method 4

the needle insertion mechanism includes an insertion biasing member which causes the insertion needle to extend in the distal direction in response to the translation of the drug container

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentUS11865310B2Handheld drug delivery device
Publication Date: 2024.01.09 AMGEN INC
  • US11865310B2 patent drawing
  • US11865310B2 patent drawing
  • US11865310B2 patent drawing

AI summary

Handheld drug delivery devices for injection of a medicament into a target location are disclosed herein. The drug delivery devices of the present disclosure include drive mechanisms, needle insertion mechanisms, and fluid pathway connectors. These components may be arranged within a housing. The arrangement of these components may provide an easy to use device that is capable of delivering volumes larger than traditionally injected using syringes. Translation of a drug container of the device may cause connection of a fluid pathway from the drug container for delivery of a medicament to a target location.