Innovations Series Presents: Pulse of Innovation

Pulse of Innovation

On the cover: Just a few of the latest innovations addressing the needs for device technology in the cardiovascular sector.

When developing critical devices such as those designed to be used for the treatment of problems with the cardiovascular system, companies are relying more on the expertise of component and service providers who offer complete solutions. This article looks at several examples that illustrate a successful end product as a result of these collaborations.

By Sean Fenske, Editor-in-Chief

At a Glance

Collaborative solutions
Sensor device
Programming ICDs
Catheter technologies

The practice of buying products for use in the manufacture of a medical device is quickly moving away from seeking an off-the-shelf solution to discovering a complete product solution provider. Enhanced service, flexibility in approach, and product customization capabilities are becoming much more important offerings to a finished device manufacturing company than shopping for simply the latest piece of technology to address a need. While finding a company providing the best technology alongside the best service offerings would be the ideal scenario, in the design of medical devices and especially when addressing critical sectors like the cardiovascular system, finding the right partner with whom to work on a project is quickly becoming the top priority.

Jeff Koslosky, director of research and development for Secant Medical—a leader in the design, development, and manufacture of engineered fabric structures for a variety of industries, including medical—explains this concept from the supplier side of the partnership model. "Secant Medical is in the business of collaborating with device professionals to bring a variety of unique materials and geometries to new cardiovascular devices. There is a natural synergy that occurs with engineers specializing in different disciplines but sharing a common focus in the creation of novel cardiovascular devices. It's resulted in an explosion of innovative approaches that leverage medical fabrics in a way not previously imagined."

The types of advances to which Koslosky refers are not nearly as common when a device manufacturer purchases an off-the-shelf product from a supplier without receiving input from that company. Through the joint effort and sharing of unique skill sets and expertise that each company brings to the table, the finished device can be enhanced, modified, and improved—all to the benefit of the patient needing the device for treatment.

The following presentations discuss unique technologies that have been introduced to the medical marketplace to treat various cardiovascular conditions. Continued joint efforts between medical device manufacturers and full-service suppliers hold the promise of similar advanced offerings in the future.

Successful Diagnosis

By Prof. Calum McNeil
UK-based medical diagnostics company Cambridge Life Sciences Ltd. develops and manufactures healthcare products and services to clinical diagnostic specialists on a global basis. The areas of focus are immunology, primarily autoimmune disease, and clinical chemistry. The company's core expertise lies in immunoassays and sensor technology.

Cambridge Life Sciences Ltd. collaborated with the University of Newcastle upon Tyne in a two-year Knowledge Transfer Partnership (KTP), to develop and bring to production a quantitative 'near patient' technology for diagnostic biochemical markers of heart disease. Part-funded by the UK government, KTPs have operated successfully for nearly 30 years, facilitating partnerships between companies and academic institutions.

When patients arrive at a hospital with symptoms of a heart attack, it is crucially important for doctors to accurately and rapidly diagnose, or exclude, myocardial infarction—death of a segment of heart muscle following the interruption of blood supply—for further treatment. In addition to ECG and patient history, doctors currently rely on centralized laboratory tests that can take between two and four hours to complete. This project aimed to develop a device that could aid doctors in the diagnosis of myocardial infarction in the emergency room or at the patient's bedside in the coronary care unit by carrying out those tests in less than ten minutes.

A sensor for fatty acid binding protein (FABP)—a cardiac marker for early (within three hours of onset of symptoms) rule-in/rule-out analysis of heart attack—was developed and transferred from the laboratory to a feasible working model. In addition, the system could also be used to determine the success of reperfusion therapy—so called 'clot-busting drugs.' The program of work involved developing the two intrinsic parts of the test device: lateral flow strip, where the biochemical recognition and chemical reaction takes place, and the transducing electrode, which translates the biochemical signal into an electrical measurable one. The use of electrochemical measuring capability also enabled internal controls for the device to be established which are pivotal for the commercial success of a quantitative diagnostic device designed to be used by non-professional staff. Quality control parameters such as flow rate, enzyme activity, and ensuring the correct steps have been performed were included in the device.

The KTP has resulted in an impressive sensor device that could deliver near-patient analyses of samples for FABP from a 20 µL blood sample in five minutes. Not only has the feasibility been proven but the research partnership also has the clinical information to vindicate the utility of FABP measurements in an emergency situation. The KTP produced a model that enabled the demonstration of the technology to a number of potential partners for exploitation, thus opening up strong collaboration opportunities.

KTP draws funding from 16 UK bodies, such as the Biotechnology and Biological Sciences Research Council and the Department of Trade and Industry. Each KTP project is based on a carefully structured plan that aims to deliver innovation and change within the company concerned. This is achieved by recently qualified individuals (called Associates) managing projects central to the development needs of participating companies, supported by the expertise and experience within academic institutions. The projects last between one and three years and enable companies to move forward technically and strategically.

Professor Calum McNeil is a professor of biological sensor systems at the School of Clinical & Laboratory Sciences, University of Newcastle upon Tyne in England. His research concentrates on the design and development of integrated electrochemical and microelectromechanical (bio-MEMS) sensors and their application to investigations of the biochemical mechanisms underlying disease processes. He can be reached at 44 (0) 191-222-8259 or calum.mcneil@ncl.ac.uk [1].

Interfacing ICDs Made Easier Through Cooperation

By Marinda Gansmoe
In May, IBM announced a significant development in the medical devices space as a result of a joint effort with St. Jude Medical. Together, the two companies collaborated to design and produce the St. Jude Medical Merlin Patient Care System, a portable system that programs St. Jude Medical's implantable cardioverter defibrillators (ICDs) and pacemakers. This state-of-the-art system is designed to help physicians conduct tests, analyze therapeutic and diagnostic data, and program implanted devices more efficiently.

The Merlin Patient Care System is a highly portable device designed to improve the programming experience of the cardiac devices during implant surgery and—once surgery is complete—remotely monitor and program implantable devices. The custom-designed solution is more advanced than anything previously available to St. Jude Medical doctors and staff. About the size of a small suitcase, the portable computer contains an LCD viewing screen with touch-point capabilities, an embedded keypad platform, and a Linux-based operating system. The hardware platform supports Merlin's graphical user interface, which enables improved workflow and dramatically enhances the user experience. St. Jude Medical has already begun distributing the Merlin Patient Care System to clinics, hospitals, and medical facilities worldwide.

Innovations Series Technology Spotlight:
Catheter Advances Support Other Cardiovascular Treatment Devices
The Asahi Tornus device is a specialty support catheter designed to help physicians access areas of blockage in the coronary arteries and other vessels that may be difficult to reach. The stainless steel device is engineered to deliver therapeutic, minimally invasive balloon catheters and stents to treat chronic occlusions, which are areas of blockage characterized by dense, fibrous plaque. Chronic occlusions, sometimes referred to as the "last frontier in interventional medicine," are often resistant to conventional interventional technology.

Support catheters are intended to provide physicians with additional assistance in accessing lesions with therapeutic wires. While most catheters are made of conventional plastic, the Tornus catheter is made of stainless steel to provide extra support during operator handling. The proprietary Tornus design consists of several hair-thin, stainless steel strands braided together to enhance flexibility and strength. Additional features include a safety-release valve at the proximal end to indicate when the device has reached maximum rotation, and a specialized tapered distal tip with a radio-opaque marker for visualizing difficult-to-access areas. The device is available in two sizes: 2.1 Fr for accessing lesions that are more difficult to navigate and 2.6 Fr for circumstances requiring more support to push through a dense, fibrous lesion.

The Tornus is manufactured by Japan-based Asahi Intecc Co., Ltd. Abbott has a licensing agreement with Asahi Intecc to distribute its guidewires in the U.S. and certain countries worldwide.

Whether medical device manufacturers develop clinical and surgical instruments, appliances, prosthesis, or electromechanical equipment, they face similar challenges including global competition, increasing regulation, and increased design and development pressure to get products to market faster. Through collaboration, IBM was able to help St. Jude Medical bring a new product to market by leveraging IBM's full range of resources, including its engineering expertise and design consultants. For medical device manufacturers like St. Jude, the need for medical device companies to collaborate with key technology vendors like IBM is critical now more than ever in order to achieve a new level of innovation.

Marinda Gansmoe is a medical practice engineering consultant within IBM Technology Collaboration Solutions. She can be reached at 651-459-7210 or gansmoe@us.ibm.com [2].

Laser Offers a CLiR Solution

By Wade Bowe
The CLiRpath line of laser catheters was developed by Spectranetics Corp. to treat peripheral arterial disease (PAD) in human legs. CLiRpath catheters provide a means to percutaneously access lesions within arteries and deliver 308 nm UV wavelength energy via a bundle of fiber optics to the lesion tissue.

Because of the various tissue morphologies and the length of the lesions, PAD is a difficult disease to treat. The consistency of the lesion tissue can range from thrombus (gelatinous-like consistency) to rock-hard calcium throughout the length of 30 cm or more. Other treatments exist, but none that address both the various morphologies and lesion lengths.

The CLiRpath 308 nm excimer wavelength provides distinct advantages for ablating blockages causing PAD. Organic molecules, including arterial plaque and blood, absorb UV light very strongly. This allows the CLiRpath catheters to readily ablate the various lesion morphologies seen in PAD. Because lesion tissue absorbs so avidly, UV light does not penetrate deeply into it (approximately 50 µm). The shallow penetration provides safety by making the catheter virtually a contact cutting device with little thermal effects. This unique characteristic along with the short pulse width of the 308 nm excimer laser allows for safe tissue removal as compared to heat producing lasers such as Argon or YAG lasers.

The CLiRpath system includes a laser console and a laser catheter. The console generates a 308 nm excimer laser beam that is sized and focused through an optical rail. The catheter couples to the laser generator using a proprietary coupler design that produces coupling efficiencies up to 55%. The light energy travels from the proximal catheter coupler to the distal tip of the catheter within a bundle of fiber optics. Depending on the size of the catheter (ranging from 0.9 to 2.5 mm in diameter), each catheter contains 65 to 250 fibers in sizes ranging from 50 to 130 µm. The majority of the catheters are 150 cm long. Since the laser energy travels through fiber optics, the catheters can easily be maneuvered within the tortuous human vasculature without compromising energy output.

Recently, the CLiRpath line of laser catheters was upgraded to include more fluence (energy per area) and repetition rate (rate of laser pulses per second) capability. The higher fluence and repletion rate allow the CLiRpath catheters to ablate the lesion tissue more efficiently. The majority of the laser catheters operate at a maximum fluence of 60 mJ/mm² and a maximum repetition rate of 80 Hz. The combination of 308 nm laser energy that ablates multiple tissue morphologies, flexible catheters that allow access within tortuous anatomy, and variable power output make the CLiRpath laser system effective in treating PAD.

Wade Bowe is the director of product development for Spectranetics Corp., 96 Talamine Ct., Colorado Springs, CO 80907. He is responsible for all new product design and development activities from concept to product launch. Bowe can be reached 719-633-8333 or wade.bowe@spectranetics.com [3].

ONLINE

For additional information on the technologies and products discussed in this article, see Medical Design Technology online at www.mdtmag.com [4] and the following websites: