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D'Antonio Consultants International
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Tully, NY 13159

Phone: 315-696-8031
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Medical Products > Jet Injectors > Human Use

Please Note: The LectraJet M3 RA needle-free injection system shown below has been cleared by the FDA for sale and human clinical use. Other systems shown below are prototypes and are not cleared for sale or human clinical use.

LectraJet® HS high speed jet injection system for mass immunization campaigns
Low Workload Jet Injector for Routine Immunizations
Concepts for Simultaneous Vaccine Delivery with Multi-channel Jet Injector

LectraJet® HS high speed jet injection system for mass immunization campaigns
Client: Centers for Disease Control and Prevention (CDC), Atlanta, Georgia
(SBIR Phase I Contract #200-98-0417; Oct. 1998 - March 1999)
(SBIR Phase II Contract #200-2000-10049; Oct. 2000-May 2006)
(SBIR Phase II Contract #200-2006-17925; Sept. 2006 – Oct. 2009)

The Problem:
The US Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) have identified the need for an easy-to-use, reliable, rapidly deployable needle-free (NF) injection system that provides protection against pre-injection vaccine contamination and that eliminates the risk of cross-infection for the billions of vaccinations administered annually throughout the world. This safe and effective way to rapidly vaccinate large numbers of people is needed, not only for mass immunization campaigns in developing countries, but also to prepare for the possibility of bioterror attacks and disease pandemics world-wide. The reason for this need is that injections often come with the risk of cross-infection and other types of infection due to:

  • Reuse of disposable needles and syringes
  • Reuse of sterilizable needles and syringes without proper sterilization
  • Improper disposal of contaminated sharps
  • Accidental needlesticks
  • Advance filling of multiple syringes (typically done to circumvent slow syringe filling process)

Unsafe injection and disposal practices put the patient, the healthcare worker and the community at risk.

The Solution:
The LectraJet® Disposable Syringe Jet Injector (DSJI) system is a high speed needle free jet injection system for both routine and mass immunization programs. The fact that the device is needle free eliminates needle reuse, needlestick injuries, sharps disposal, and reduces the pain and fear associated with needle injections. The system is low cost, reliable, hand-held, and lightweight to reduce the likelihood of user fatigue. Both manual and battery power options are available, with the battery option providing several thousand injections per battery charge.


LectraJet® HS Injector (Electrically Armed - powered by an internal battery and motor)


LectraJet® M3 RA Injector (Manually Armed - by Reset Station shown below)


Reset Station (Injector is installed and ready for manual arming)


LectraJet® M4 Injector The Next Generation manually armed injector
(The LectraJet M4 Injector is half the size and weight of the LectraJet M3 RA Injector)

 

The LectraJet® NF Syringes:
The LectraJet® DSJI systems utilize NF syringes that are single-use and auto-disabling to eliminate the risk of cross-infection that is associated with the older style Multi-Use Nozzle Jet Injectors (MUNJI). The LectraJet® system allows for hands-free handling of the NF syringes to reduce the risk of contamination.

Filling LectraJet® NF Syringes:
LectraJet® NF Syringes are filled directly from the vaccine vial, or alternatively, directly from a reconstitution syringe. The filling process is extremely rapid (NF syringes are filled twice as fast as a vaccinator can deliver injections). This high speed filling process removes the incentive to fill in advance. In addition, all fluid path components are disposable and single-use so that no reuse issues exist, such as improper sterilization.

Managing LectraJet® NF Syringes:
LectraJet® NF Syringes are packaged sterile and housed in a "magazine" to maintain cleanliness during the on-site filling process and to provide for efficient, rapid vaccination without requiring the vaccinator to handle the NF syringe directly. Alternatively, NF syringes can be packaged individually for slower speed applications.

Low Workload Jet Injector for Routine Immunizations
Client: Centers for Disease Control and Prevention, Atlanta, Georgia
(Contract #200-98-0419; October 1998 - March 1999)

Objective:
Routine Immunization Clinics around the world deliver vaccines to children using needles and syringes: a simple, effective, and inexpensive method for parenteral delivery of drugs and vaccines. However, because of improper sterilization and possible reuse of the needle and syringe, the danger of transmission of blood-borne disease is very high, especially in resource-poor settings.

In an attempt to eliminate the problems associated with needles and syringes, multi-use nozzle jet injectors, were once used for immunizations until they were found to transmit blood borne pathogens between patients. Their use was stopped and the world was left with no alternative to needles for immunization.

The objective of this contract was to develop a new, safer, needle-free jet injector suitable for use in routine immunization clinics in both developed and developing countries.

Solution:
DCI designed a manually armed needle-free jet injection system that uses auto-disabling single shot disposable cartridges to eliminate the possibility of both pre-injection contamination and post-injection cross-infection. The system is quickly and easily manually prepared for the next injection, which allows for use anywhere in the world regardless of available power supplies.

Results:
DCI designed and fabricated a prototype model, which has been used for animal testing. Fabrication of a next phase manual prototype is currently in process.

Multi-Channel Jet Injector for Simultaneous Vaccine Delivery
Client: Centers for Disease Control and Prevention (CDC), Atlanta, Georgia
(Contract #200-97-0641; August 1997 - January 1998)

Objective:
New childhood vaccines are being developed rapidly, but children, parents, and providers are less willing to accept the increased numbers of separate injections required at a single doctor visit. Missed immunizations can result in increased disease occurrence among unprotected children. Combination vaccines are an alternative, but potential chemical incompatibilities require years of expensive research and regulatory approval to ensure that vaccine efficacy and safety are not compromised. The objective of this project was to determine the scientific, technical and commercial merit and feasibility of a multi-channel jet injector to deliver multiple vaccines simultaneously.

Solution:
The multi-channel jet injector must deliver several injections to the appropriate depth, and within the space available on the thigh of a small child. DCI carried out extensive analyses to determine the appropriate system parameters, and these were followed by laboratory testing and system design.

Results:
A paper design was required to satisfy the contract, but DCI provided analyses of several potential techniques, paper designs for two of the most promising approaches, and a working prototype for the selected design. This prototype was successfully demonstrated for the CDC Measles Eradication Committee.

 
 
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