Saturday, August 11, 2007
First, I would like to thank Drs. Wang and Frayer for instituting such a program – I absolutely loved my experience this summer. There was so much I learned about medicine, surgery, health care, how engineers fit into health care, human dynamics, myself, etc., etc… not to mention, being able to enjoy New York City in the summertime. If you haven’t noticed…this summer was priceless for me and I am very grateful to have had this opportunity. I also would like to thank Dr. Grant for being my mentor. Although, I enjoyed surgery in general, I found a special enjoyment out of plastic surgery and I think that can be attributed to having a great mentor and plastics squad.
I hope everyone else had as great of a time as I did this summer and best of luck to all of the future participants in the program. Get involved and enjoy the experience, you will probably never do anything like it again. That’s it all...for now...
Tuesday, August 7, 2007
Anyway, as I showed in my presentation my research project basically consisted of a literature review and case study analysis to form the foundation for a prospective investigation of Dr. Grant’s. He wants to assess the effect short pulsed electromagnetic fields have on post-op breast augmentation patients. I won’t go into everything that I presented on; however, some of the more interesting findings were as follows. First, was a meta-analysis of over 30 years and 50 clinical trials on both bone and soft tissue revealing that ALL studies were methodologically flawed…awesome. I’m glad published research is so well reviewed…and carried out for that matter. Some of the flaws were huge, too – like no control groups or errors in the protocols. Honestly, I thought that was outrageous. Nonetheless, these were studies from years ago, and a lot of the newer studies are much better designed. Several of the better, more recent articles showed that in vitro and in vivo PEMF stimulated the synthesis and upregulation of various growth factors, such as, platelet-derived growth factor (PDGF), vascular endothelial growth factor (VEGF), and transforming growth factor (TGF). These growth factors then act to induce cellular proliferation, angiogenesis, stimulation of an immune response, deposition of ECM and wound contraction. In other words, they aid in wound healing and in turn should also help reduce pain in human subjects by speeding up the healing process. The chart below illustrates an increase in tensile strength of rat wounds treated with PEMF for 21 days post-op as compared to the negative controls. Signal I, II, III, and IV are simply varying doses of PEMF; whereas the "Sham" is the negative control.
A company called Ivivi Technologies in
The electric field induces a magnetic field and the device is laid on the wounded area, applying the desired PEMF therapy directly onto the patient’s wounds. It’s a non-invasive therapy that allegedly reduces pain and speeds along the healing process, allowing for an earlier discharge, and thus, cutting costs, too…that is if it actually works. A cool idea. But, it just looks so bogus to me. Anyway, the company has just released news that they have an IRB-approved, randomized, double-blind, placebo-controlled clinical trial on 30 ischemic cardiomyopathy patients (decreased blood flow to the heart) who are not candidates for surgical procedures. If it works in these cases, that would be absolutely great…it could reduce the number of many invasive, difficult cardiac surgeries. Personally, I think the biggest obstacle with this technology will be convincing the general population that a stupid wire with a flashy LED on it will actually save you…
Sunday, August 5, 2007
Surgical staplers and clip appliers are complex mechanical medical devices that have been on the market for years and are mature in their technology. These devices are used in gastrointestinal, gynecologic, thoracic, and many other surgeries to remove part of an organ, to cut through organs and tissues and to create connections between structures. The benefit of using these devices allows for more complex procedures and shorter surgical procedure time.
However, Each year over the past 5 years there have been 8,000 to 9,000 adverse event reports related to surgical staplers. The most common problems with the device are: staples don't form, staplers misfire or don't fire. The most common problem with the patient is anastomosis failure. This is also where my research project originally arise from. Solving the anastomosis problem is meaningful.
In the OR, I also saw electronic surgical staplers. Compared to mechanical stapler, it provides improvements such as, removes force from the anastomotic site; digitally senses tissue compression levels; digitally selects staple heights; prompts surgeon via LCD and voice message.
By talking to the doctors and the engineers from the vendors, I feel that the research in a medical device company is somewhat different from research in the school. In the school, the research is more focused on the basic science, but in a company, it must be application oriented. For example, the physical principles inside a stapler have been well established since Newton and Maxwell. However, such a device is still innovative because it facilitates doctor’s procedures, and it fundamentally changed suturing process. The research is a designing process. Instead of incorporating a lot of high technologies, a device that best meets the doctor’s need might be more useful.