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Stanford University

A Medical Device to Treat Gallstone Disease

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Stanford University, 2009 - $18,968

Biliary colic is a condition in which a gallstone becomes lodged at the gallbladder outlet, and, if left untreated, can cause severe and life-threatening infections. The most common treatment for this disease is surgical removal of the gallbladder, but due to a high risk of complications in the elderly and critically ill, surgery is not a viable option for over 200,000 patients per year. Instead, they're treated with conservative management, which is often unsuccessful. This E-Team is looking to develop a safe and effective alternative for these patients, as well as the large numbers of patients in developing countries where surgery isn’t an option. Since the gallbladder in patients with stones is actually normal and the stones are harmless provided they are kept away from the outlet, the team has developed a novel stainless steel filter device to prevent stones from reaching the outlet. The filter is delivered through a catheter and expands after deployment. Radial force holds the filter in place. The geometry of the filter prevents stones larger than two millimeters from passing.

Xtracycle

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Stanford University, 1998 - $8,100

Recipient of two NCIIA grants, the Xtracycle E-Team developed a cargo bicycle conversion kit that transforms a standard bike into a "sport utility bicycle," or SUB. The kit stretches out the rear wheel behind the seat, creates a big, stable platform on top of the rear wheel for a load or a passenger, and places expandable saddlebags on either side. The bike is still lightweight and fast because the load is centered between the wheels, helping fill the void between large, cumbersome utility tricycles and small, ineffective racks and bags. Its versatility and performance make it ideal for hauling loads that were previously considered too long, too heavy, or too fragile to be transported by bicycle, from surfboards to passengers to groceries.

The team evolved from a group of students at Stanford into Xtracycle LLC (xtracycle.com), a manufacturer, educator, and vehicle for social change. The company promotes their proprietary designs as boundary-pushing bicycles and soul-satisfying alternatives to automobile dependence. Profits from Xtracycle support Worldbike (worldbike.org), a non-profit organization that seeks to make their technology available to people in developing countries.

Both companies are targeting sustainable transportation as their ultimate goal.

Global Health by Design

Stanford University, 2006 - $37,500

This grant supports the Global Health by Design (GHbD) project, an innovation fellowship that will address world health challenges through medical device design at Stanford University. The fellowship will be a collaboration between anthropology, engineering, medicine, public health, international economic policy, and business. The fellowship is built on the assumption that, in order to create and disseminate effective medical technologies in developing countries, the process needs to take place within sustainable businesses and industries in those same countries.

NCIIA funding is going toward cross-institution planning, which will take place for one year and include: choosing a host country, making connections with key colleagues in that country to facilitate the clinical immersion of the fellows, and finding partners in the host country to actualize the business plan and fund raising. GHbD will recruit four fellows, one of whom might be from the host country, and will train the fellows through a six-week boot camp that will include classroom lectures on health care, background on needs identification, information on basic biomedical technologies, an introduction to intellectual property, health care regulation, and basic health care technology economics. Fellows will travel to the host country in September for a three-month immersion, during which they will participate in the local health care delivery system and identify at least 250 clinical needs. On returning to Stanford, the fellows will process the clinical needs, conduct extensive research on forty of them, develop a detailed written profile of the clinical background, and present the profile to a faculty from the host country. Following this, fellows will invent several solutions to each problem. The solutions will be evaluated for technical feasibility, practicality, cost and manufacturability. Students from the Biodesign Innovation Class will further develop these concepts and GHbD fellows will serve as TAs for the course.

Strengthening Manufacturing Capacity of Burmese Metalworking Firms to Promote Sustained Development

Stanford University, 2007 - $49,480

International Development Enterprises (IDE) sells a wide variety of agricultural-output-increasing technology to the world's rural poor, including a popular treadle pump that increases the availability of water and raises household income by an average of $150 annually. IDE-Myanmar's sales of the pump have doubled each year since 2004, but with the scaling up of operations, managing efficient quality manufacturing in a less industrialized economy has become a pressing issue. Stanford's Design for Extreme Affordability students and faculty will work with IDE-Myanmar to design and implement a manufacturing system that enables the organization to meet its treadle pump production goals. This will involved investigating local Myanmar manufacturing conditions, designing a production system based around local needs, refining the system, and implementing it. Based on previous research, the team believes introducing an improved manufacturing process for treadle pumps will broadly improve the metalworking sector.

Summer 2009 update: Starting in late 2008, student and faculty teams held workshops at IDE-Myanmar. This team has designed and implemented a handful of jigs and fixtures, as well as set up and iterated a quality control system for metalworking firms. A quarter-long student project assisted IDE-Myanmar with process mapping and production pricing. The team has been able to analyze several rounds of QC data that they helped set up the collection of for IDE-Myanmar, which has allowed them to target areas for improvement. They plan to publish and disseminate their findings on the Burmese metalworking industry.

More about Lab-on-a-Stick, 2009 BMEidea winners

Submitted by dave on Fri, 07/24/2009 - 08:55

Stanford University's  Lab-on-a-Stick team talks more about their BMEidea award-winning innovation, here.

 

A Novel Device to Perform Cardiac Resynchronization Therapy for the Treatment of Congestive Heart Failure

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Stanford University, 2004 - $18,369

This E-Team developed a device that simplifies the process of implanting Cardiac Resynchronization Therapy (CRT) devices in human hearts. CRT devices (e.g., pacemakers) are used to treat instances of congestive heart failure (CHF). Implanting them requires attaching electrical leads to the ventricular walls of the heart, which in turn cause the heart to contract at regular intervals. This E-Team's device allows surgeons to access the left ventricular wall (the harder of the two walls to reach) by passing that electrical lead through the right ventricle, rather than routing it separately into the left ventricle. This approach allows for faster procedures with fewer surgical obstacles, minimizing the chances for failure.

CHF is a major (and growing) health problem, especially in the US. While pacemakers currently improve the lives of many people with CHF, the failure rate for the implant procedure is about 8%. Furthermore, there are many patients who are too sick to undergo such major surgery. Because this device lessens the operating time and avoids the obstacles surrounding the left ventricle, it could presumably make an impact in both of these groups.

Percutaneous Large Arteriotomy Site Closure

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Stanford University, 2005 - $16,675

Arteriotomies (the surgical incision of an artery) are required for all catheter-based procedures. Current medical practice requires a large, open incision, an invasive procedure which increases recovery time, hospital and procedure costs, and patient discomfort. To combat these problems, this E-Team developed a device that closes large arteriotomies percutaneously--that is, closes them through the skin in a minimally invasive procedure. The device consists of two components: a vessel-cutting tool, which creates an incision in the vessel of the specific size and shape of the catheter to be used, and a closure mechanism, made of a pre-placed nitinol structure, that provides complete hemostasis to the arteriotomy when the catheter is removed.

A Novel Aortic Endograft with Adhesive-mediated Fixation and Seal for Endovascular Treatment of Abdominal Aortic Aneurysms

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Stanford University, 2005 - $15,898

Abdominal aortic aneurysm (AAA) is a dangerous swelling of the abdominal aorta, the vascular conduit that supplies oxygenated blood to the legs. Rupture of AAAs account for 15,000 deaths annually in the US. Open surgical repair of AAAs is currently the gold standard therapy, but comes with significant drawbacks: mid-procedure mortality rates range from 1.4-7.6%, and a number of patients are ineligible for the surgery because they cannot tolerate its invasiveness. As an alternative to open surgical repair, many new stent-grafts have been developed that slide into the aorta and essentially exclude the aneurysm from circulation. These devices are seen as a promising treatment that could reduce mortality rates, patient recovery time, and procedural costs, yet current stent-grafts are suboptimal: only about half of AAA patients are eligible for stent-graft treatment because of the varying anatomy of aneurysms, and the stent-grafts themselves suffer from long-term durability issues involving leaking and the migration of the devices from the site of the aneurysm. To address these issues this E-Team proposes to develop a stent-graft with an adhesive delivery platform that actively seals the stent-graft and fixes it securely in place in the aorta.

Update: the team, now incorporated as Endoluminal Sciences, has received $2 million in venture capital funding and is moving toward clinical trials.

A Novel System to Improve the Efficacy of Percutaneous Catheter Ablation of Atrial Fibrillation

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Stanford University, 2005 - $7,250

Atrial fibrillation (AF) is a cardiac rhythm disorder that can lead to heart palpitations, chest pain, and clot formation that can lead to strokes. Medications used to control the symptoms of AF have had limited success and come with significant side effects. Recent research suggests that AF is caused by electrically abnormal cells in the right and left side pulmonary veins; with this in mind, percutaneous catheter techniques have been developed in which a catheter is used to ablate (destroy) the conducting tissue around the abnormal cells, electrically isolating them so that they cannot initiate AF. However, this procedure has had limited success due to the fact that the catheter cannot always access the right-sided pulmonary veins given their physical location in the body and the variability of pulmonary vein anatomy from person to person.

To address this issue, this E-Team developed a novel sheath system that can target a catheter directly toward the right-sided pulmonary veins, leading to more effective AF ablations. The sheath system utilizes an anchored trans-septal sheath and an inner, pre-shaped guiding sheath to direct the ablation catheter directly toward right-sided pulmonary veins. The team also designed several inner sheaths to optimize the targeting of the catheter depending on whether the right superior, right inferior, or both right-sided pulmonary veins together are being isolated.

A Device to Accurately Access the Epidural Space for Administration of Anesthesia

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Stanford University, 2006 - $18,500

This E-Team is developing a safer, more controlled method of performing an epidural. The current technique involves the advancement of a needle into the epidural space, relying heavily on a steady hand and the ability to halt needle advancement once loss of resistance is detected. Since this is a time-consuming process with a complication rate of 5-20%, epidurals are not used as often as they could be; less than half of epidural-eligible patients actually receive one.

The team's device consists of a rotating blunt-tipped syringe attached to a flexible shaft and operated by a pump actuator equipped with a safety alert button. This design has four advantages over the traditional model: 1) the blunt tip allows the physician to dissect, instead of cut, through to the epidural space, making the procedure easier and safer; 2) the device uses rotation to create controlled advancement of the needle, relying less on a steady hand; 3) the flexible shaft minimizes the torque encountered with a rigid one-piece system; and 4) the design maintains the familiar and reliable loss-of-resistance method to detect the epidural space.

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