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A Needle as Thin as the Mosquito’s Mouth

By Stanley Kim, MD

Posted On: Feb 1, 2011

As vividly as yesterday, I remember what happened 20 years ago.

Bill was a 50 year-old man with lung cancer metastatic to the brain. The brain lesions had recurred despite conventional radiation therapy. At the University of Southern California he had finished another round of radiation by gamma knife, the new method of treatment at that time. Because of deep vein thrombosis of the leg, he had been admitted to the hospital in Upland, California, and I was just walking out his room after the round when he called out to me. He was trying to hand something to me. I took it and bent my head to see it. To my surprise, it was a check for $10,000.

“I don’t know how to express my gratitude to you,” he said in a weak and slightly hoarse voice. On his trembling lips a shadowy smile appeared.

Tweenty years ago this $10,000 check was hardly a small amount of money, especially to someone who had started a new medical practice and was, of course, in need of financial stability. Not only because it was rude to reject his offer but also because I honestly wanted to have that money, I took it. But thinking that I was hesitating, he said, “You don’t need to do it. Thank you so much.” Bill had accumulated great wealth by working as a construction contractor. Just three months later he died.

About three years ago, my fasting blood glucose level was high at 135 mg/dl. I had diabetes. By following a low carbohydrate diet and getting some more exercise, I was able to bring my blood glucose levels down to normal without taking any hypoglycemic drugs. I continue to check my blood glucose level at home.

But checking my level meant puncture pain from those big needles. I became increasingly resistance to the daily finger pricks that those checks required. I tried every available lancet on the market – the OneTouch from Johnson & Johnson’s LifeScan, the Accu-Chek Multiclix and Softclix from Roche, the FreeStyle from Abbott, and the BD lancet from Becton, Dickinson. But all those lancets were more or less the same in the amount of puncture pain they caused.

Necessity is the mother of invention, and I came up with an idea of a painless lancet. What if I made the needle as thin as the mosquito’s mouth?  If the blood coming out from the skin were not enough for glucose testing, could two or three needles in a bundle mounted on a lancing device body produce two or three times the amount of blood amount as a single needle? So I contacted a patent attorney to file a patent application. Then, I asked a Japanese engineer in Tokyo to make a prototype lancet with two 3mm-long 38-gauge needles mounted on the end of a lancing device.

As I hoped, the first prototype lancet that the engineer made did not cause puncture pain. However, I found out that a 3mm long 38-gauge needle could bend when it hits hard, calloused skin. Furthermore, someone else had already patented the idea of multiple needles mounted on a lancing device. I fell into deep despair because I had spent a good deal of money and time on it the prototype lancet.

Still, the amount of blood from a single 38-gauge needle was enough to test blood glucose levels with the new glucose meters on the market. So having two or three needles was unnecessary.

Nevertheless, I remained busy with my practice. A patient named Doris with newly diagnosed laryngeal cancer was referred to me for treatment. She was a 78 year-old woman who I later found was the older sister of the late Bill, who had died 17 years earlier having left such a strong memory in my mind and $10,000 in my bank account. I wondered if they carried cancer genes, although they both smoked, and it is well known that smoking is the most common cause of both lung and laryngeal cancer. Fortunately, a combination of chemotherapy and radiation therapy put her cancer into complete remission, which repeated laryngoscopy and PET/CT scans confirmed.

Around that time I had a strange dream. In the dream Doris was writing a check. She showed it to me, which reminded me of Bill giving me a large check many years earlier. In the dream I thought that Doris simply wanted to show me the wealth she possessed. Since she drove a Mercedes, and didn’t seem like someone who showed off, I assumed that she had written a check for several million dollars. But to my great surprise, I saw in my dream that she had added two or three more zeros, making it a $300,000,000 or $3,000,000,000 check.

When I woke up, I still felt the dream was real. Later, when I told Doris of my dream, she laughed out loud and said she wished that she had that kind of money.

Despite my setbacks with making better needles, I was still devising and studying them whenever I could make time during my busy medical practice. I felt some urgency, since I had seen newborn babies in the hospital crying sharply in a shrill, fretful tone obviously in pain when those ordinary 28- or 30-gauge needles punctured their heels. I also found that no lancets were suitable for children, since lancets with the same old thick and long needles were used for adults and children alike.

Finally, I came up with a lancet that satisfied my conditions. It had to be painless, produce enough blood for testing, not intimidating visually, mass producible, compatible with currently available lancing devices, and patentable.

I found the secret. The needle had to cut only the capillary complexes in the papillary layers of the dermis, while not touching or irritating the free nerve fibers beneath. This lancet had to predictably and consistently penetrate no deeper than the papillary layer, regardless of skin conditions. Additionally, it had to minimize the dwell time between the needle and the skin.

The measured depth level of the papillary layer of the fingertip is about 0.6-0.8mm, although it may vary depending on the thickness of the epidermis. For example, a heavily callused finger has a 1mm-thick epidermis. Therefore, I devised a lancet having a needle of 38-gauge and of 0.75mm thickness mounted on a pedestal-shaped structure at the distal end of the lancing device.

Using the lancets that I invented, I conducted a randomized clinical study with about 40 people with diabetes to test whether my invention really was painless while producing enough blood for glucose testing. I published the results in a peer-reviewed medical journal, Clinical Medicine Insights: Endocrinology and Diabetes.

Recently, the International Diabetes Federation invited me to present my clinical study at its meeting in Busan, South Korea. In the United States, the Food and Drug Administration has approved the sale of my lancets under the name “TiniBoy.” They are available through www.Tiniboy.com and www.amazon.com. This year, the Korea Intellectual Property Office issued a patent for these lancets, and I am preparing to sell them there before the end of 2011.

I will continue to develop the TiniBoy lancets in hopes that someday they will achieve great success. To date, however, I have had considerable development expenses and haven’t yet made any money from them.

Actually, I remain somewhat hopeful, because of the Doris dream. My true dream is to build and operate charity hospitals and cancer centers wherever people need them.

It has been said that one’s fate is sealed and predetermined to run a certain course as soon as it was set into motion regardless of one’s desire and effort. It could be my fate that I will fail despite my vigorous efforts. It is Doris’s choice whether or not to give me the check, regardless of my desire.

Realistically speaking, the odds of success in this business are low. Start-up companies reportedly succeed only about 3 to 5 percent of the time.

So far, the only comfort I get is the many thank-you letters from parents of children with diabetes whose pain I have been able to greatly ease by using my painless TiniBoy lancets. At times, in fact, I consider this business as a charity, because I have been spending my money and time only to help others without any guarantee of success.

I was once convinced by this theory of fate, because I learned that I could not change the fate of many cancer patients. No matter how hard I tried, having seen those cancer patients die against my and their will, I could not do anything except to humbly accept God’s will.

However, it looks sublime and even holy to see the extraordinary efforts of doctors and patients together trying to save patients’ lives. Furthermore, I occasionally have seen cancer patients who survived against the odds when doing their best and not giving up easily, making me wonder if the theory of fate is always true.

Suppose there is a poor Mexican woman with ovarian cancer living in Mexico where no adequate cancer treatment is available and is surely destined for an early death there with the chance of long-term survival of less than 5 percent. In the U.S. ovarian cancer is treatable with a high chance of survival, even at an advanced stage. Then she decides to cross the border to go to San Diego for treatment, as American hospitals treat anyone with an emergency medical condition regardless of their immigration status or ability to pay. Then, her chance of survival goes up to 50 percent as soon as she makes that determination  to cross the border, when she could get caught and turned away. But if she makes it across, her chance of survival goes to more than 90 percent in the hospital’s emergency room.

Regardless of Doris’s initial intention not to give me her big check, when I have a deep desire and determination to get it, I might persuade her to give it to me. Then the theory of self-determination of fate becomes true, like it would be for the hypothetical Mexican woman. One can change the course of the fate, succeeding with determination, vigorous effort, and faith, raising the probability of success from a mere 5 percent to 90 percent.

The dream of Doris only showing the check to me may be interpreted as the Tiniboy business having the unfortunate fate of not making a great deal of money. However, even if that interpretation is correct, if I can make my dream come true through the great success of the TiniBoy business with my best effort. Just as the Mexican woman changed her fate, the theory of self-determination, not the theory of fate will be proven right.


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