In the Begining
TransLite LLC was started in 1992 to commercialize an innovative product called the Nevoscope for skin cancer detection. The Nevoscope device was designed by Dr. Atam Dhawan and used an innovative technique called side-transillumination for making a small area of the skin translucent. A patent was issued on the Nevoscope design to Dr. Dhawan and was assigned to Mr. Nizar Mullani for commercialization.
A new Nevoscope was designed by Mr. Mullani to incorporate cross-polarized surface imaging of the skin together with side-transillumination for skin cancer detection. This new device was used in a clinical study funded by the NIH to study the use of transillumination for skin cancer detection. The study was carried out at M D Anderson Melanoma Center under the direction of Dr. Duvic. Ms. Claire Terry was hired to oversee the image and data acquisition for this study. Over 250 skin lesions were imaged using the new Nevoscope. Five different modalities of imaging skin cancer were obtained for each lesion including contact and non-contact imaging with cross-polarized imaging and transillumiination.
Preliminary results from this study were presented at the American Academy of Dermatology Annual conference in 1998 by the researchers from M D Anderson Cancer Center. These results showed that cross-polarized imaging was a simple way of imaging superficial structures in the skin lesion while transillumination showed the deeper structures better. Moreover, imaging the skin lesion with contact glass plate reduced the “blush” caused by increased blood volume in a skin lesion. This was observed with both cross-polarized imaging and transillumination imaging. The effect was stronger for transillumination imaging.
Creation of the Dermilite
Cross polarized imaging of skin lesion was found to be very effective and easy way to image early skin cancer without the use of contact glass plate and oil as was used in the Dermatoscope in those days. In 2000, Mr. Mullani built a prototype of a small white LED based cross-polarized device called the DermLite for imaging skin lesions. This was demonstrated at the Annual Academy of Dermatology meeting in 2000 and a partnership was formed between Mr. Mullani, Mr. John Bottjer and Mr. Thorsten Trotzenberg to commercialize the DermLite for skin cancer detection. The newly formed company was called 3Gen and its first product called the DL 100 was introduced in 2001 at the AAD meeting. Today, over 50% of the dermatologists use DermLite products to screen for skin cancer and non-contact imaging with polarized light has become the main mode of skin cancer imaging for clinical screening.
The Origin of Veinlite®
The concept of the Veinlite® device originated from the clinical results collected with the Nevoscope. Two very consistent pieces of information about transillumination imaging became clear to Mr. Nizar Mullani, the Primary Investigator of the NIH funded research.
- Blood vessels were seen better with transillumination imaging than with cross-polarized imaging.
- Deeper blood vessels could be seen easier with transillumination than polarized imaging.
An attempt at trying to remove these blood vessels, from skin lesion images by software, was not very successful. Finally, an early morning epiphany in 1996 led to designing a simple side-transillumination device with an opening in the ring to image superficial blood vessels. This device was called the Veinlite® and utilized a fiberoptic ring light with a powerful light source to regionally transilluminate a small area of the skin for blood vessel imaging. Several attempts at marketing this new concept of imaging blood vessels with side-transillumination were not successful even though a dual light Venoscope device existed for imaging veins.
The Breakthrough in the Acceptance of Veinlite®
The breakthrough in the acceptance of Veinlite® as a useful device came in 1999 when a presentation of the new Veinlite® for vein imaging was presented by Nizar Mullani at the American College of Phlebology. The abstract presentation was awarded the second best scientific award and 10% of the attendees bought a Veinlite® at the meeting to use for finding deeper feeder veins during the treatment of varicose veins with sclerotherapy.
An arrangement was made with Mr. Sam Wagner to sell the Veinlite® devices through his company since Mr. Mullani was still an Associate Professor at the University of Texas Medical School in Houston, Texas. Very quickly, the Veinlite® became an important tool for doctors treating patients with superficial varicose veins. It remains to this day as one of the most important devices for finding the deeper feeder veins that feed the superficial varicosities.
Veinlite® for General Vein Access
While the Veinlite® was becoming popular for treatment of varicose veins, the underlying belief that the Veinlite® could be beneficial for general vein access took a long time to get accepted by the medical community. Attempts at developing a special device for use with pediatric patients for general vein access were not successful with the NIH grant applications. It was not deemed important by the reviewers since vein access was considered to be quite successful overall. However, 35 years of experience in the hospital and seeing multiple failed attempts at vein access, convinced Mr. Mullani that general vein access could be improved.
TransLite LLC funded a clinical trial at Boston Children’s Hospital to use the fiberoptic Veinlite® in a randomized clinical trial to access veins in the hard-to-find vein patients in the Emergency Department. This trial took about three years to complete and a final report was published by Katsugoris et al in Pediatric Emergency Care, Vol 24, Number 2, Feb 2008. The report showed that the use of the Veinlite® improved the success rate for vein access from 74% to 83% after two attempts in children with hard-to-find-veins. This was the first, and still remains the only randomized clinical trial to demonstrate the use of transillumination for general vein access.
Creation of Veinlite LED®
While the clinical trial was going on, Mr. Mullani carried out research on how to create small pocket devices that could be used by nurses during vein access. From the experience with the use of the Veinlite® for sclerotherapy, it was obvious that side-transillumination was an excellent way of accessing small superficial veins. It also became clear that the design of the Veinlite® ring helped close off the vein and traction could be applied to the skin by pushing the ring back from the opening. This would then secure the vein and make it easier to access the vein. This aspect of the use of the Veinlite® for general vein access is now trademarked by TransLite as ‘Veinlite® Vein Access™’. However, the current design of the Veinlite® was not very easy to use by the nurses because it was not easily portable.
The research question was how to create a hand-held device that could operate on a battery and not use 150 watts as in the Veinlite®. After two years of research, it was found that orange/amber light provided the highest contrast for imaging superficial blood vessels while red light penetrated deepest for imaging deeper veins. The two colors of LEDs could produce reasonable images of veins using only two watts of power or less and a design of a portable Veinlite® device called Veinlite LED® was created in 2004. Commercial versions of the Veinlite LED® were sold in 2005.
The innovative findings about the orange color was patented by Mr. Mullani and the patent was awarded in 2011. The combination of the orange and the red LED lights soon proved to be very successful for imaging superficial and deeper veins with the Veinlite LED®.
The original goal of creating a portable device that could be used by nurses for general vein access now became a reality with the Veinlite LED®. It soon became obvious that these portable devices were very useful for finding veins in children, large patients and patients undergoing chemotherapy. Five other variations of the Veinlite LED® have been designed to optimize them for different applications. The newest Veinlite LED+® provides a larger area of illumination than the original Veinlite LED® delivering higher contrast for more effective vein imaging than its predecessor. The Veinlite EMS PRO® is designed for use by pre-hospital emergency services, adding a built-in white exam light for patient assessment anywhere, anytime. The Veinlite LEDX® is a larger, more powerful version of the Veinlite LED® and is perfect for use in the field of sclerotherapy. The Veinlite PEDI2® is a compact device, streamlined for use on children of all ages (0-17 years), providing light color selection and brightness control. The Veinlite Neo® is specially designed for finding veins and arteries on neonates (up to 8 weeks), using through the body transillumination. The Veinlite R® brings Veinlite's transillumination innovation to the Animal Research market, enabling fast, easy vein and artery access in mice and rats.
Several patents have been issued on different aspects of the Veinlite® devices. Veinlite® products are now sold in over 70 countries around the world and several million people per year are benefiting from the use of the Veinlite® for finding veins and accessing them using the new Veinlite® Vein Access method.
During the development of the Veinlite® devices, we have been fortunate to have several excellent collaborators whose contributions have been extremely helpful in developing the final products. See below.
Patents (Related to DermLite and Veinlite® only)
Nizar A Mullani: Illuminated mirror employing cross and parallel polarization. 3gen February 2006: US 7004599 (1 worldwide citation)
The present invention relates to an illuminated personal hygiene mirror for viewing facial skin or other areas of the body. In each of the embodiments of the present invention, a hand-held frame receives and supports a mirror. The mirror is covered with a polarizer for polarizing any reflected
Nizar A Mullani: Vein holder.May 2012: US 8177808
The vein holder has an upright wall forming a central opening. The central opening is large enough to allow easy access by a needle. A bottom flange extends outwardly from the wall and rests against the patient's skin. It is the bottom surface of the flange 14 which holds the skin tight to prevent...
Nizar A Mullani: Transillumination having orange color light.January 2011: US 7874698
The transillumination device has an orange light, in the range of 580-620 nm. Orange light has been found to be beneficial for superficial veins. Red light is used for deeper veins and darker skin. The transillumination device may have a single light source able to change colors. Two different ...
Nizar A Mullani: Dermoscopy epiluminescence device employing cross and parallel polarization. 3gen January 2007: US 7167243
The present invention is a hand held dermoscopy epiluminescense device with a magnification lens and an associated ring of luminous diodes powered by an on board battery. Every other diode in the ring operates as first and second light sources. The even diodes are filtered by a first polarization ...
Nizar A Mullani: Dermoscopy epiluminescence device employing multiple color illumination sources. 3gen January 2007: US 7167244
The present invention provides a hand held dermoscopy epiluminescense device having a generally circular optical magnification lens incorporated into the housing of the device. A lighting array provides the light necessary for medical examination of the skin. The lighting array comprises a ring of ...
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