Self-locking syringe

Abstract

The invention relates to a self-locking syringe designed to address the problem of disease transmission caused by the intentional or accidental reuse of injection equipment. DEOLIS holds the technology that meets the demand for a Type 2 RUP syringe – a self-locking hypodermic syringe – with an innovative process that also meets market economic expectations. The developed system features a syringe nozzle with a compact mechanism, the entire assembly being compatible with a standard syringe barrel. The ring, made of a soluble material whose components are approved by the French Agency for the Safety of Health Products (AFSSAPS), permanently prevents refilling, even partial, and thus constitutes the system's main advancement, thanks to the properties of the selected components.

Description

Title of the invention: Self-disabling syringe

[0001] The invention relates to a self-locking syringe to address the problem of the spread of diseases caused by the intentional or accidental reuse of injection equipment.

[0002] To address the problem of the spread of diseases caused by the voluntary or accidental reuse of injection equipment, DEOLIS has undertaken two research projects in this regard:

[0003] - The invention consists of replacing the sharp part, which is used for piercing, with a tip soluble in the human body made of an approved material making this part harmless after use.

[0004] - The self-locking system allows the filling of a syringe, then the injection of a product, leading to the unblocking of a mechanism (ring made of a soluble material whose compounds are AFSSAPS approved) which permanently prevents a second filling, even partial.

[0005] DEOLIS wishes to carry out initial work on this issue by carrying out a priority feasibility study, with the objectives of developing a physical demonstrator and implementing the validations requested by the WHO.

[0006] Innovative character of the self-disabling syringe

[0007] Analysis of syringes with manual or semi-automatic retraction (SIP + RUP) ISO 23908 and ISO 7886 standards

[0008] The syringe is equipped with a device that raises the needle into the body. Retraction can be either manual (push the plunger then pull it until the needle is completely retracted) or semi-automatic (with retraction carried out by a spring activated at the end of the stroke).

[0009] The synthesis of these mechanisms shows that the different devices available on the market are manually activated systems, or semi-automatic needle retraction systems that can multiply the cost of the syringe by 10. In both cases, securing the syringe is an additional task to be added to the injection process, its effectiveness is therefore dependent on the habits and attention of the injector.

[0010] The DEOLIS company proposes to meet the demand for Type 2 RUP syringes (classic hypodermic syringes, with automatic safety) through the innovation of the self-locking syringe. The system consists of a syringe nozzle with a compact mechanism, the assembly being compatible with a standard syringe barrel.

[0011] Progress of the auto-disable syringe program

[0012] A first prototype syringe incorporating the self-locking system was developed in the laboratory. The FDM (Fused Deposition Modeling, filament printing) manufacturing process was used during this phase to manufacture the nozzle and a standard barrel. The low cost of this method and its ease of implementation made it possible to compare current valve technologies, to adjust the valve technology in its different options and to propose a first functional prototype to test the self-locking system.

[0013] This first success must now lead to the development of a self-locking demonstrator with materials meeting the standards of medical specifications and to a pilot production of one million syringes with the chosen process. This phase is essential to provide all the elements and certainties before approaching the industrialization stage.

[0014] Compliance with standards for the manufacture of medical syringes

[0015] The standards relating to the design of a safety hypodermic syringe are as follows:

[0016] - ISO 7886-1: Sterile, single-use hypodermic syringes - Part 1: Syringes for manual use.

[0017] - ISO 7886-4: Sterile, single-use hypodermic syringes - Part 4: Syringes with a device preventing reuse.

[0018] - ISO 80369-7: Small-bore connectors for liquids and gases used in the health sector - Part 7: Connectors for intravascular or hypodermic applications.

[0019] - ISO 15223-1: Medical devices - Symbols for use with information to provided by the manufacturer - Part 1: General requirements.

[0020] - ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.

[0021] These five standards may refer to others dedicated to the dimensioning of the needle, its protection, or to specific applications:

[0022] - ISO 7886-2: Sterile, single-use hypodermic syringes - Part 2: Syringes for electric syringe pumps.

[0023] - ISO 7886-3: Sterile, single-use hypodermic syringes - Part 2: Auto-disable syringes for fixed-dose vaccination.

[0024] - ISO 23908: Protection against puncture wounds.

[0025] - ISO 7864: Sterile hypodermic needles, non-reusable.

[0026] - ISO 8537: Insulin syringes, sterile, non-reusable, with or without needle.

[0027] The technology of the self-locking system being fixed, it is necessary to refine it. This first study thus went through a stage of innovation which converged towards a technical solution detailed in this report. With a view to commercializing the self-locking system and to validate the requirements of the standards, the following points must be addressed:

[0028] - Choice of material and process for making the tip: the material will depend its compatibility with medical fluids and the human body, as well as its shaping possibilities because the working dimensions are small. A list of candidates was selected.

[0029] - Choose the industrialization process: it is necessary to define whether the system is a assembly of existing parts, or if manufacturing processes need to be implemented. If necessary, it is first necessary to ensure the intellectual property constraints of the parts and materials (patent, licenses).

[0030] - Work on dimensioning and drawing: the plans present in this document allows us to get closer to the final model, however they are not produced according to a standard manufacturing standard.

[0031] - Create a final demonstrator: a prototype must be made with the materials selected and according to the final industrial processes to get as close as possible to the final version of the product.

[0032] - Mechanical tests: the standards describe a panel of tests allowing quantification and to validate the syringe's performance. It is necessary for the prototype to validate these standards to solidify the final design.

[0033] - Prepare the missing elements to validate the standards: once the technology validated, it is important for the standards to define the parameters not covered in this document such as the syringe sterilization technique, its graduation and its packaging.

[0034] - Prepare the normative file: it must contain the result and the validation criteria of all the requirements of the standards relating to the product.

[0035] - Prepare the legal file in order to protect the techniques and patents that Deolis will have created during its research program for the development of the auto-locking syringe process point.

[0036] - Drafting the INVENTION DISCLAIMER for a Provisional Patent Applications will require the intervention of an international legal firm with several stages in the process: France, Europe and other countries concerned depending on the development strategy adopted.

Claims

Claims

1. Self-locking syringe comprising a standard type barrel characterized in that it comprises a nozzle comprising a compact mechanism, which allows the syringe to be filled, then a product to be injected, causing the safety mechanism to be unlocked, said safety mechanism being of the valve flap type having a ring made of a soluble material which definitively prevents a second filling, even partial.

2. Self-locking syringe according to the preceding claim in which the barrel and the nozzle are manufactured using a manufacturing process of the FDM - Fused Deposition Modeling type in filament printing.