Revolutionizing Wrinkle Treatment

A solid model rendering of Salzman’s Ouchless Need design.

Providing patients with efficient and pain-reducing injections was the goal for Dr. Marc J. Salzman, a double-board certified plastic surgeon in Louisville, KY, when he conceived and first began inventing Ouchless Needle in 2007.

Now fully commercialized, Ouchless Needle is an integrated and efficient vapocoolant delivery system designed to ease minor localized pain. This innovative and ergonomic device dispenses a user-controlled and precise FDA-compliant vapocoolant spray, instantly numbing the skin, just prior to the needle piercing the skin.

The Ouchless Needle Collection currently consists of three models marketed to meet a wide range of universal and proprietary syringes commonly used in the cosmetic injection industry and other clinical practices. These patent-pending models use a snap-on, or a clip, system to hold the device firmly in place with the syringe, while also permitting quick changes for additional syringes during procedures. Each disposable device holds vapocoolant for about 20 effective sprays for pain reduction from needle piercing of the skin.
 

Value Proposition
With aging demographics and their popular desire to appear younger, neurotoxin and dermal filler injection procedures rose nearly 400% during the past decade, according to the American Society of Plastic Surgeons. Performed in the United States, and costing $2 billion, have been more than 7.2 million of these minimally invasive procedures, with the United States representing perhaps only about 12% of international procedures, according to various leading industry association and research data.

Unlike other numbing agents available in the market, the Ouchless Needle device easily attaches to multiple common syringes allowing the clinical practitioner to instantly spray and inject using only one hand. As a result, the patient encounters a better experience including reduced pain and waiting time, while the clinician captures procedural and office efficiencies. Each disposable device holds sprays for approximately 20 injections and can be re-attached to another syringe and used on the patient until the coolant device is empty.

These types of injections have traditionally been available through plastic surgeon and dermatology medical practices and medspas, but are also becoming increasingly available through general medicine, gynecology, hair transplant, and otolaryngologist offices and in alternative settings.

Beyond the cosmetic market and hair restoration practice, there is potential market extension to any need for an efficient and precise delivery of pain relief application. Focused on therapeutic applications is nearly half of the total neurotoxin market. In the future, Ouchless Needle may also enhance patient experiences in, for select illustrative purposes, urgent care, dental, and pediatric settings.

“It occurred to me that pain of the injection was a deterrent to an otherwise minimally invasive procedure,” Salzman says.

He considered clinical journal articles demonstrating that instantly-acting vapocoolants provided comparable clinical efficacy as other pain reducing methods, such as EMLA numbing creams, in cosmetic injections. Vapocoolants also work for patient comfort and protecting the epithelium during cosmetic laser procedures. However, early vapocoolant products – typically available in either large glass dispensers or aerosol cans – were cumbersome and inefficient to apply focally to the face.

Other common pain reducing methods, such as numbing creams, are messy and time-consuming, while ice causes a frostbite feeling to the face with subsequent dripping of the melting water.
 

 
Conceiving a Solution
Although a full-time practicing physician, Salzman pursued assessing the design, patent, and commercialization opportunities for such a device. After completing daily surgeries and consultations in Louisville, KY, he spent the evenings communicating with a California medical device designer on the telephone and via email. They eventually developed early working prototypes and began the patent filing process.

With prototypes in place, Salzman was looking for a company that could finish designing, set-up a manufacturing line, and conduct the 510(k) pre-market filing with the Food and Drug Administration (FDA). A colleague at the University of Louisville Medical School, where Salzman is a clinical associate professor, steered him toward CreoSalus Inc. and its Louisville-based medical device division, Occam Design, for high-quality contract development and manufacturing.

What developed was the partnership between Occam Design, a fully integrated medical device design and manufacturing company, and Salzman’s new company, BellaNovus Development LLC. Occam Design took leadership of the project, moving it from the early conceptual prototype to manufacturing. All design and manufacturing activities followed FDA and ISO 13485 medical device regulations, for use to support 510(k) filing and securing a CE-mark.
 

 
Chemical Challenges
During this systematic development process, however, the product went through design and engineering iterations as the management team identified and resolved flaws and concerns until settling on the current miniature and ergonomic design and vapocoolant mixture.

Premise of the initial concept of the device was on chloroethane or monochloroethane, commonly known by its vapocoolant market name, ethyl chloride. Ethyl chloride is a fluid useful as a propellant and cooling fluid and has adequate vapor pressure and evaporating temperature. This chemical compound formula, C2H5Cl, once widely used in producing tetra-ethyl lead, is also a gasoline additive. It is a colorless, flammable gas or refrigerated liquid with a faintly sweet odor.

According to Vasiliy Abramov, Occam Design, “Ethyl chloride, however, presented two major drawbacks for the design team.” He points out that, “First, most common materials (rubbers and plastics) for the product casing do not have a good chemical compatibility with ethyl chloride. Second, the vapor pressure of the fluid was insufficient to generate the correct spray pattern and pulverization.”

Next, there was identification of alternative refrigerants for potential use to meet the criteria. Another challenge to overcome was that most refrigerants are in vapor phase at room temperature, and in order to work with them, special equipment or cold temperatures are necessary. Through the prototyping it was determined that the mixture of R134f 5% and R245fa 95% delivers the best spray pattern and pulverization.

As the FDA has already evaluated both refrigerants for topical human use, the team moved forward with it in testing and production.
 

TOPAZ The Ouchless Topaz model is well suited for the basic purposes of many toxins and fillers, particularly Botox and Dysport. Topaz provides a great fit and quickly snaps onto the syringe for easy on and off for multiple syringe sizes. Each individually packaged device includes an adapter to on a narrow 1cc slip-tip syringe. Alternatively, without the adapter, the device fits perfectly with the 1cc Luer-lok syringe size. The FDA compliant blend of vapocoolant in this model has been tested to provide 19 sprays (at 0.5 seconds of spray), on average.

 
Plastic Casing Design
An ergonomic fit with the injector’s hand and a preferred aesthetic styling were other key factors in the device’s design. As an attachment to a syringe, it needed to be lightweight, not bulky, easy to use, hold the syringe firmly in place, and with clearly readable syringe measurement markers.

With a design concept and vapocoolant mixture finalized, engineers created solid models and drawings using 3D CAD design software. After several variations, the team was able to create a solid model of the device that was easy to manufacturing and had an appealing look and have an ergonomic shape.

At the same time, required was a vessel with a valve to hold and accurately dispense the mixture of refrigerants. Market ready aerosol cans and valves, however, were inadequate to fit inside of the ergonomic device housing. Engineering of custom canisters for small volumes was next, and then design of the valve components to fit miniature canisters. Then there was simplification of a new valve design, unnecessary parts removed, and bulky components miniaturized.

With the design finalized, the team procured manufacturing tooling and equipment and the manufacturing line was established and launched. Use of the initial units produced was to gather data needed for FDA filing. It took the team approximately one and one-half years from concept to commercialization in order to meet FDA compliance and to secure a CE mark. Throughout the development process, Salzman and his team were attending industry trade shows and meeting with doctors to obtain early constructive feedback from leading clinicians.

The Ouchless Needle eliminates waiting time and works instantly reducing the pain associated with having injections.

In parallel with development of the manufacturing process, was the addition of two more devices to the Ouchless family, including one with a clip built into it that provided a firm grip on syringes of different diameters. All devices have the same appearance and feel, easily identifiable as part of the same product line-up.

The Ouchless Needle Collection reached full commercialization in late 2011. With targeted marketing programs and expanding distribution, clinicians and consumers alike are learning about the benefits of Ouchless and are increasingly adopting it into their injection needs and preferences.

Ouchless Needle
Louisville, KY
OuchlessNeedle.com