# Presentation: 064985

## LectraJet® HS (high speed) Needle-Free Injection System for Routine Immunization and Mass Immunization Campaigns 

*Funding provided by Centers for Disease Control and Prevention **(SBIR Contract # 200-2000-10049)*

- D’Antonio Consultants International, Inc. (DCI)
- _www.dantonioconsultants.com_

**Notes:**
LectraJet Injection Systems is a new family of jet injectors  under development by DCI, Inc.  

The LectraJet HS is a high-speed, high-workload, electrical or manually powered, needle-free Jet Injection System designed for both large scale immunization campaigns and routine immunizations.  It uses individual single-use cartridges to deliver the vaccine safely with no risk of cross-infection.

Funding for this Development is currently provided by a Phase II Small Business Innovation Research Contract with the United States Centers for Disease Control and Prevention. 

## DCI, Inc. Jet Injection Projects

**1988:**  Grant with Johns Hopkins
- develop battery-powered injector
**1996-1998:**  USDA Small Business Innovation Research (SBIR) Grants, Phase I & II
- veterinary injectors
**1997:**  CDC Phase I SBIR Contract
- multi-channel injector
**1998:**  Two CDC Phase I SBIR Contracts
- high- and low-workload injectors
**2000-Present:**  CDC Phase II SBIR Contract
- high-workload for measles mass campaigns

**Notes:**
This slide just lists out a few of our jet injection projects.  In the interest of time, I won’t review these in detail, but if there are any questions, we would be happy to answer questions afterward.

## Status of Research and Development

- Proof-of-principles demonstrated
- Working prototypes built
- Bench/laboratory performance testing done
- Animal testing for depth and dispersion done
- Design review for manufacture and risk analysis
- _Remaining stages_
- 510(k) clearance
- Human adult depth and dispersion MRI studies
- Human adult Anthrax trials
- Pediatric **MMR** or **MEA** safety and efficacy trials
- Developing country field feedback
- Developing country mass campaign feasibility trials

**Notes:**
Our Research and Development project has been progressing steadily.

We have proven the principles for our injector and our filling system and we have built and tested prototype models, some of which we’ll show in a demonstration in a few minutes.  
Animal testing has shown the injector is capable of delivering both subcutaneous and intramuscular injections.
We are currently reviewing the design for manufacturability.

We are currently preparing our 510(k) submission in the US for clearance to market the device.  
We will soon begin human adult trials using MRI to look at depth and dispersion of the injectate.  
We will follow that with adult trials with Anthrax vaccine in a separate project with the University of Maryland’s Center for Biodefense.  We will also carry out pediatric trials with measles vaccine and developing country feasibility trials.

## LectraJet® HS Subcutaneous (SC) Injection(10 kg piglet)

- Post-mortem cross-section photo of india ink injectate in fat.

*In vivo* Magnevist® injectate
- enhanced in red on MRI.
- Yellow line is computed
- central axis of injection.

- Courtesy: N. M. Szeverenyi, SUNY Upstate Medical University, Syracuse

**Notes:**
Suggested text to save time:

AT THE STATE UNIVERSITY OF NEW YORK UPSTATE MEDICAL CENTER IN SYRACUSE, WE RECENTLY COMPLETED DEPTH AND DISPERSION STUDIES IN 10 KG PIGLETS.  

THIS SLIDE SHOWS A SUBCUTANEOUS INJECTION.  ON THE LEFT IS A PHOTO SHOWING THE CROSS SECTION REVEALED BY THE SCALPEL OF THE DISPERSION OF THE INJECTED INDIA INK (point to ink).  

ON THE RIGHT IS AN MRI SCAN WITH THE INJECTATE ENHANCED IN RED COLOR (point to red blob).

++++++++++++++++++++++++++++++++++++++++++++++
Original Text:

Piglet Test #1
Piglet A, Injector DCI-BJ-10 at location C4 (Photo #153; MRI Stack 31-106)

## LectraJet® HS Intramuscular (IM) Injection(10 kg piglet)

**LectraJet*****®***** HS *****Intramuscular (IM) Injection***(10 kg piglet)

- Post-mortem cross-section photo of india ink injectate in muscle.

*In vivo* Magnevist® injectate
- enhanced in red on MRI.
- Yellow line is computed central
- axis of injection.

- Courtesy: N. M. Szeverenyi, SUNY Upstate Medical University, Syracuse

**Notes:**
HERE ARE A COMPARABLE PHOTO AND MRI IMAGE OF AN INTENDED INTRAMUSCULAR INJECTION.  

YOU CAN SEE THE INDIA INK (point to left photo) IS IN THE PINK MUSCLE BELOW THE WHITE SUBCUTANEOUS FAT.  

ON THE RIGHT AGAIN IS THE MRI IMAGE WITH THE INJECTATE SHOWN IN RED.  

+++++++++++++++++++++++++++++++++++++++++++++++++++
Original text:

Piglet Test #1
Piglet A, Injector DCI-MJ-06 at location F10 (Photo #191; MRI Stack 41-30)

## Desired Characteristics:Design Specifications of CDC

***Safety***
- Disposable, single-use, auto-disabling cartridges
- Clean end-user filling of cartridges
- Cartridges capable of vaccine manufacturer pre-filling
- Hands-free loading and ejecting of cartridges
- All sterile components provided; no field sterilization
- Prevent firing if filled cartridge not properly seated
- No sharps waste

**Notes:**
The CDC’s main concerns for this device were Safety, Speed, and Cost.

In terms of safety, we designed the device for single use auto-disabling cartridges which can be filled on-site from standard vaccine vials or can be prefilled by the manufacturer.  

The cartridges are loaded into and ejected from the injector without the vaccinator touching them to prevent touch contamination.

The components of the fluid path are entirely disposable, so that there is no requirement for field sterilization.

Of course, there is no sharps waste, and the injector can only deliver the injection if it is prepared properly.

## Desired Characteristics:Design Specifications of CDC

***Speed ******(for Mass Campaigns)***
- _>_600 injections / hour        (>10 / minute = < 6 seconds each)
***Low cost***
- Competitive with autodisable syringes

**Notes:**
CDC’s requirement on Speed for mass immunization situations is one shot every 6 seconds.  Our system actually exceeds this rate, although there may be few situations where such rapid immunization would be needed or even possible from a logistical perspective.

Cost is, of course, of utmost importance in developing countries.  As currently designed, the LectraJet HS per shot cost is competitive with autodisable syringes.

## LectraJet® HS System Components

- Case
- Cartridges
- Handpieces & power sources
- Magazine
- Filling System

**Notes:**
These are the components of the LectraJet HS system. Everything shown in this presentation is covered by DCI patents.   I’ll discuss each of these components in turn.

## LectraJet® HS Case

- For shipping and travel
- Includes legs to use case as work platform

**Notes:**
The LectraJet HS System is delivered as a complete kit 
contained in a carrying case.
The case contains all system components needed to carry out a mass campaign.  It also provides for excellent portability and organization, and in situations where flat surfaces are not easy to come by, the case can have extendable legs to serve as a table.

## LectraJet® Cartridges

- Polycarbonate with molded orifice
- Autodisabling piston      Single use
- Packaged sterile for end-user filling
- Filled on-site via orifice
- Capable of manufacturer prefilling
- Low cost at high volumes

**Notes:**
Injections are delivered from the needle-free single-use autodisable cartridge.  One patient, one cartridge. 

The polycarbonate cartridges have a molded orifice at the front end, as shown on the left of this picture, and a flange at the back end for grasping by the injector handpiece, as shown on the right side of the picture.   

When the injector handpiece is actuated, the piston drives the vaccine out through the orifice to create a jet stream with enough energy to penetrate the tissue.  At the same time, the piston is autodisabled, thereby preventing refilling and reuse of the cartridge.

The cartridges will be packaged empty and sterile for end-user filling, but they will also be capable of prefilling by the manufacturer.

When filled on-site, the cartridges will be filled via the orifice end.  

In high volumes, the cartridges are low cost.  

## LectraJet® Handpieces and Power Sources

- Two versions: Manual and Motorized
- Steel spring creates force to deliver shot
- “Fingers-free” grasping of filled cartridge
- “Fingers-free” release of used cartridge
- Rapid delivery of injections
- Very little maintenance required
- No o-rings or seals to change
- No sterilization required

**Notes:**
The handpiece and power source  deliver the injections from the individual cartridges.

The handpiece comes in two versions, manually powered and motorized, and both versions use a steel spring to create the force to deliver the injection.  

And both allow for fingers-free grasping of new filled cartridges from a magazine and fingers-free release of empty used cartridges into a trash container.  This prevents contamination of the vaccinator’s hands at all points during the injection process.

The combination of fingers-free grasping and release of the cartridge and a very short cycle time to prepare the injector for the next shot contributes to rapid sequential delivery of injections. 

Very little maintenance is required, there are no o-rings or seals to change, no sterilization of the handpiece is required.

## Handpiece – Manual Model

- Spring compressed manually
- Suitable for either ...
- High-speed masscampaigns without electricity (600/hr)
- Routine clinic use

**Notes:**
For the manual model, various methods for compressing the spring are possible and may be suitable for different applications.

The manual version is a simple and fairly low cost device, especially suitable for routine use in clinics and for high-speed mass campaigns without access to electricity.

## Manual LectraJet in Action

## Handpiece – Motorized Model

- Spring compressed by internal motor
- Rechargeable, replaceable battery pack in handle
- Several thousand injections per charge
- Battery-charging – AC mains,vehicle battery, solar, etc.
- Backup manualspring compression possible

**Notes:**
In the motorized model of the handpiece, electric power from a rechargeable, replaceable battery pack drives an internal motor that compresses the spring.

The battery pack is attached to the handle of the device and provides several thousand injections from a single charge.

The battery can be charged in any number of ways, including AC mains, vehicle battery, solar power, a gas or manual generator, and so on.

In addition, as an emergency backup, the spring can  be compressed manually.

## Magazine

- Manages cartridges for efficiency and speed
- Minimizes cartridge handling
- Maintains cartridge cleanliness

**Notes:**
The next component of the system is the magazine, which protects and manages the cartridges before, during, and after filling.

This ensures an efficient, high speed operation, and minimizes cartridge handling in order to maintain cleanliness

## Magazine

- Orifice end of cartridge...
- Friction fits into magazine
- Recessed and protected by covering to maintain cleanliness before and after filling
- Mounts on carrying case, vaccinator’sarm, or any firm surface
- Low cost plastic
- Cost for 30 cartridges in magazine (sterilized and wrapped) is similar to cost of autodisable syringes, in quantity

- Bottom view

**Notes:**
During packaging, the orifice end of the cartridge friction fits into the magazine, as shown in the top picture.  
As shown by the bottom picture, the orifice is recessed from the magazine opening and is protected by a proprietary covering that maintains cleanliness before and after filling.

The cartridges are removed from this magazine by pressing the front of the injector against the back end of a cartridge to grasp it.

This magazine can mount on the carrying case, any firm surface, such as a chair, table, post, box, or a tree trunk, and even on the vaccinator’s forearm.

This magazine is made from low-cost plastic.  The cost is based on a large quantity quote for cartridges installed in the disposable magazine, sterilized, and wrapped.  This is within the price range of autodisable syringes, making this system economically feasible for use in developing countries.

## Filling System

- Fill on-site from vaccine vial through cartridge orifice
- Can also fill from autodisable reconstitution syringe
- Use with liquid or reconstituted lyophilized vaccines
- Minimize vaccine handling
- Disposable fluid path      no field sterilization requirements

**Notes:**
The filling system allows for clean, safe, rapid end-user filling of the cartridges, which are delivered empty and sterile to the end user.

Cartridges are filled on-site through the orifice from the vaccine vial of liquid or lyophilized vaccine.

The filling system minimizes vaccine handling while providing clean, safe, rapid end-user filling, and the disposable fluid path means that field sterilization is not necessary.  

## Filling System

- Pump fluid from vial into cartridge
- No finger contact with sterile pathways between vial changes
- No wasted doses in fluid path
- Fully disposable fluid path
- Manually index to nextcartridge

**Notes:**
Proof-of-principle models have shown that our proprietary pumping system can move vaccine from the vial into the cartridge without wasting vaccine in the process.

The picture shows this type of pump in a filling station.  The magazine full of cartridges sits in a holder (in red) with the covered orifice ends pointing up.  The holder indexes along a base plate to position the cartridge orifices precisely below a disposable filling interface.

The vaccine vial attaches to the top of the disposable filling interface.  Pressing down on the handle causes the filling interface to engage with the orifice and activates a valve that allows vaccine to flow through the filling interface chamber and then into the  cartridge. 

There is no finger contact with sterile pathways, and the filling components are disposable so that no sterilization is required.

## Review of LectraJet ® Attributes

- No cross-infection risk
- SQ or IM delivery of vaccines
- High or low speed operation
- Long-term reliability for high workload use
- Minimal training and maintenance
- No field sterilization
- Cost competitive with autodisable syringes

## LectraJet ® Regulatory Timeline

- 510(k) submission expected January, 2004
- Review and clearance expected March, 2004
- Human trials begin March 2004

## D'Antonio Consultants International, Inc. (DCI), 6308 Fly Road, East Syracuse, NY 13057
www.dantonioconsultants.com, LindaD1@twcny.rr.com

***LectraJet******®****** HS*** (high-speed) Needle-free Injection System

- D'Antonio Consultants International, Inc. (DCI), 6308 Fly Road, East Syracuse, NY 13057
- www.dantonioconsultants.com, LindaD1@twcny.rr.com

**Notes:**
The LectraJet HS system addresses the most important concerns regarding safety, speed, and cost in a mass immunization campaign and in a routine immunization clinic.  The Handpiece, Magazine, and Filling Station options provide flexibility to allow the system to be used an a wide variety of settings. 

At this time, we are continuing our development of the filling stations and magazines to insure safe and effective management of the cartridges.  In the near future, we will begin our human trials with the handpiece and cartridges.

For more information, please contact:
Linda D’Antonio
DCI, Inc.
6308 Fly Road
East Syracuse, NY 13224

Phone:  (315)463-4999
FAX:  (315)463-5267
Email:  LindaD1@twcny.rr.com

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