In order to improve the safety of healthcare staff by preventing NSIs, C-Major Medical has developed a range of products based on our innovative and unique patented approach to the safe retraction of needles. Other devices could be developed using the same platform concept.
Our first products designed and sampled are a Blood Collection Tube Holder (UNISON™), a range of Auto-Retractable Syringes (DUET™), which are capable of providing safety during both injection and aspiration (taking fluid from a patient), with samples of 10ml version available and a device that can be added to an existing prefilled syringe to make it retractable (SOLO™).
All these products use our Controlled Helical Retraction Device (CHoRD™) which contains a patented ‘Helical track’ mechanism for controlled acceleration of the needle during retraction. It also contains a ‘Sealed Port’ to minimize splutter, and to allow for aspirated fluid containment. These CHoRD™-based products have unique features to prevent both NSIs and blood aerosols not seen in other safety devices.
We also have a design for a Retractable Needle Holder which connects with a tube, which can be used with devices such as a blood collection bottle (TUTTI™).
A retractable safety syringe that can be used for both aspiration and injection
The standard size CHoRD™ can be used to produce a full range of sizes of syringes from 0.5ml to 50ml.
The DUET™ syringe can be used for the same medical procedures as standard, non-safe syringes, including aspiration and intravenous injection, whilst bringing all the benefits of the CHoRD™.
In order to safely use the DUET™ syringe for aspiration, we have developed and patented the Companion for Dispensing Aspirant (CODA™). This simple adaptor allows the aspirated fluid, such as blood, to be safely transferred in complete safety to a sample vial after the needle has been retracted.
C-Major Medical have also designed a holder which can be used with standard vacuum blood collection tubes. UNISON™ incorporates the benefits of the CHoRD™ which allows the needle to be safely retracted as soon as the blood collection procedure is complete.
Designed to be supplied to companies who have existing pre-filled syringes, the SOLO device converts their syringe to a retracting version without the need to complete a full regulatory approval.
Designed but not yet manufactured, the TUTTI is intended to be used to connect a standard needle to a tube which can be then connected to a collection device such as a Blood Collection Bottle. The needle can then be safely retracted at any time.
Minimises 'splutter' and aerosols of potential infectious blood or harmful injectant during the retraction of the needle.
Allows one-handed triggering, the timing of which the practitioner is in total control of. This allows the device to be made safe at any time, even if the procedure is not complete.
‘Luer lock’ design uses standard needles, giving total flexibility in line with all medical practices e.g. changing needles and preventing the need to stock syringes with dedicated needles.
Splutter (also known as ‘sputter’ and ‘spatter’) is caused in auto-retracting safety devices by the acceleration of the needle as shown below but it can also be caused by flicking the syringe/needle to engage a needle guard safety shield. C-Major Medical’s patented CHoRD™ system uses a sealed port and a control system to minimise splutter as the needle is retracted to safety.
The production of splutter by safety devices is causing concern as described by The Journal of Hospital Infection.
This slow-motion video was produced on a test rig for C-Major Medical and demonstrates the splutter produced by an unsealed needle containing dyed water as it is retracted vertically. This test rig was built by Origin Product Design Ltd. during the design and testing of C-Major Medical’s CHoRD™ device.
Needle Retraction is driven by spring or other stored energy system
Rapid acceleration of the needle does not create sufficient momentum in the fluid of the needle
The patient’s blood is sprayed into the air as a fine aerosol of droplets – splutter
Needle retraction is driven by spring
Patented ‘helical track’ mechanism controls the acceleration, speed and deceleration of the retraction
The ‘sealed port’ prevents a pressure difference. The controlled acceleration and sealed port minimizes splutter
Whereas auto-retracting (also known as ‘passive’) syringes are more effective at reducing NSIs than any other safety system, and are forecast to be the fastest growing segment of the safe syringe market, there are several issues that have been reducing their uptake.
To increase the uptake and thus be more effective, auto-retracting devices that overcome significant restrictions in the medical applications where current devices can be used will need to be developed. C-Major Medical devices have been designed to overcome all of these restrictions.
Uniquely, C-Major Medical’s devices can be used for all syringe applications (including where only non-safe and active devices have been used), together with the increased effectiveness at reducing NSIs brought by automatic devices.
C-Major Medical’s new products have been designed with the clinician in mind. After extensive discussions with users, a need for a product that was as close as possible to an existing, simple syringe or blood collection tube holder was identified. The product must, however, have the ability to get rid of the needle whenever the clinician needs to, as well as prevent splutter.
The key requirements of the design were:
Based on these requirements, the CHoRD™ retraction module was developed which controls the acceleration of the retracting needle and seals the needle before it retracts to reduce splutter.
The ChoRD™ platform was used as the basis for the design of a range of products. The first products will be an auto-retracting blood collection tube holder and a range of auto-retracting syringes as described above.
The clinician can choose and attach a standard needle with a luer.
The syringe can then be used exactly as a conventional device
As soon as the procedure is complete the clinician just has to press the button to retract the needle which then is safe
The syringe can then be disposed of in exactly the same way as a conventional syringe
The syringe can be used exactly as a conventional device to to aspirate
As soon as the procedure is complete the Clinician just has to press the button to retract the needle which then is safe
The CODA is then fitted to the front of the syringe and the aspirant can be decanted into a suitable container, whilst the contaminated needle is safely contained within the device
The syringe can then be disposed of in exactly the same way as a conventional syringe
© 2024 C-Major Limited. All rights reserved. Registered in England and Wales – Number 5563638
