Injection Needle Assembly with Sealing Spacer
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Solution Overview
Problem
Existing medicament injection devices require multiple steps for assembly, can expose needles to damage during storage and handling, and may suffer from needle clogging due to medicament contact, leading to inefficient and uncomfortable use, especially for patients with impaired physical ability.
Innovation Solution
An injection needle assembly with a deformable spacer element and sealing membrane that protects the needle during storage and assembly, allowing easy and sterile exposure upon use, and a deformable shield for the proximal end to facilitate easy attachment to the device.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the needle assembly is stored separately in sterilised packaging and assembled by the patient before use, then the needle remains sterile and protected during storage, but the patient has to perform several time-consuming steps that are uncomfortable especially for patients of impaired physical ability
Solution Approach 1:
The patent combines the needle assembly with the cartridge holder into a single integrated unit. The needle is pre-mounted in the holder during manufacturing, and the entire assembly is sterilized together as one component. This eliminates the need for patients to separately assemble the needle and holder, reducing the number of steps from multiple manual operations to simply attaching the pre-assembled unit to the device.
Solution Approach 2:
The needle assembly is pre-assembled and pre-sterilized during manufacturing before reaching the patient. The needle is already positioned and secured in the holder with appropriate spacing elements in place. This preliminary preparation during production transfers the assembly task from the patient to the manufacturing process, where it can be performed under controlled sterile conditions.
2Ease of operation
If the needle is exposed during storage and transportation to maintain accessibility, then the needle can be easily accessed, but the needle may be damaged by temperature exposure and unintended bending
Solution Approach 1:
The needle is nested within the cartridge holder structure, with the spacing element positioned between the needle and the holder wall. This nested arrangement protects the needle from external forces during storage and transportation while keeping it accessible when needed. The holder acts as a protective enclosure that prevents bending and damage without requiring the needle to be exposed.
Solution Approach 2:
The spacing element acts as an intermediary component between the needle and the holder. It provides a buffer that prevents direct contact between the needle and potentially damaging surfaces, while still allowing the needle to be positioned correctly and accessed when needed. This intermediary structure protects the needle from temperature-related damage and mechanical bending.
3Ease of operation
If the needle is pre-filled with medicament in a syringe-based system, then the device is simple to use, but the medicament remains in contact with the needle during storage causing clogging and delayed delivery
Solution Approach 1:
The system separates the medicament storage (cartridge) from the needle assembly, with the spacing element creating a physical gap between them. This segmentation allows the needle to remain separate from the medicament during storage, preventing clogging, while still enabling quick connection and injection when needed. The spacing element ensures that even in close proximity, the needle does not contact the medicament prematurely.
Data Source
Figure 1A~1B
Figure 2~3B
Figure 4A~4B
AI summary
The present invention relates to an injection needle assembly (16, 116, 216, 316, 416) for use in a medicament delivery device (10). The injection needle assembly comprises an injection needle holder (27), an injection needle (17) fixed to said injection needle holder (27), the injection needle (17) having a proximal end (18) and a distal end (19), and a sealing assembly (25) for sealing the distal end (19) of the injection needle (17). The sealing assembly (25) comprises a spacer element (31) surrounding the distal end (19) of the injection needle (17) and a sealing membrane (32) for sealing the distal end (19) of the injection needle (17).