The ElishaHeart Group is developing a breakthrough in the treatment of end stage Heart Failure. The ElishaHeart* patented innovation will significantly improve the performance of heart assist devices by emulating the function of the natural healthy heart. This breakthrough technology promises to save thousands of lives each year and improve the quality of life for many more patients with heart failure.
The goal of The ElishaHeart Group is to complete the development of a next generation ventricular assist device through the first human implant trials. At that point, the ElishaHeart technology can be licensed to major marketers of cardiac assist devices.
THE CHALLENGE: THE CHANGING LANDSCAPE OF HEART DISEASE
Medical science has made major inroads in the treatment of Heart Disease, the leading cause of death in the United States. Many patients, who in earlier years would have succumbed to their heart disease, are alive because of modern medical treatment. These patients frequently have sustained significant damage to their heart from a previous heart attack or other cause. The functional capacity of their heart is permanently impaired and they go on to develop heart failure, the inability of the heart to pump sufficient amounts of blood. Heart Failure has become the major challenge in the treatment of heart disease. The National Heart, Lung and Blood Institute, a branch of The National Institute of Health, reports that the present pool of Heart Failure patients in the U.S. is over 6,000,000 people. There are 650,000 new cases added to this pool each year and Heart Failure is the leading cause of hospital admission for patients over 65 (with an annual cost of over $25 billion). The patient pool will only increase as the population ages.
THE UNFULFILLED PROMISE OF MECHANICAL VENTRICULAR ASSIST DEVICES (VADs)
Today the only generally accepted cure for end stage Heart Failure is a heart transplant. In the US only about 2,000 heart transplants can be done each year because of the limited number of available donor hearts. An alternative treatment utilizing some type of mechanical pump to assist or replace the failing heart is urgently needed.
Work has been underway for many years to develop just such a pump. In recent years a number of these devices have been refined to the point that they have received FDA approval and are implanted clinically in some patients with end stage heart failure. Most of these devices incorporate a flexible pumping bladder enclosed in a hard shell and two one way valves. The bladder is driven either electrically with a pusher plate or pneumatically and these devices provide pulsatile flow. They are however still plagued with significant problems that limit widespread use, including thromboembolism, infection, durability and large size.
In an effort to overcome some of the problems, axial flow devices were introduced. These are small turbines or centrifugal pumps that assist the circulation providing continuous rather than pulsatile flow. These devices have also been refined to the point that they can be implanted in some patients but they introduce a whole new set of problems related to loss of pulsatile flow.
Clearly a pulsatile device emulating the function of the natural heart would be ideal provided it could overcome the problems associated with presently available devices.
THE ELISHAHEART INNOVATION
The ElishaHeart technology brings an entirely new design concept to pulsatile ventricular assist devices. An expansile (elastic) pumping bladder is used. This is in contrast to the flexible pumping bladder or diaphragm used in current pulsatile devices. This expansile pumping bladder emulates the action and function of the walls of the natural heart. During the filling phase (diastole) the walls of the pumping bladder are stretched by drawing a vacuum on the driving side of the bladder. Elastic energy is stored in the walls of the bladder and this energy is then used to pump, or help pump, the blood as the bladder wall snaps back to its resting position during the ejection phase (systole). This action provides a method for modeling the flow of blood through the device. By making various areas of the walls of the pumping bladder out of polymer material with different viscoelasticity and different thickness, some areas of the wall of the pumping bladder can be designed to stretch earlier than others and some areas can be designed to snap back earlier than others.
In the natural heart, all the muscle in the wall of the ventricle does not contract simultaneously. Various segments contract earlier than others. As these various segments contract in a sequential fashion, they gently “milk” the blood through the heart. By appropriate design of the pumping bladder, the ElishaHeart device will gently “milk” the blood through the pumping bladder similar to the way the muscular walls of the heart ”milk” the blood through the natural heart. Shear, Reynolds number and other parameters of flow will be maintained in physiologic range and the flow will be laminar. Non-physiologic shear and other parameters of flow as well as turbulence are major contributors to thromboembolism and other problems seen in presently available pulsatile assist devices.
In other pulsatile ventricular assist devices only very limited modeling of flow is possible as it is done primarily by changing the geometry of the device. In the ElishaHeart device the expansile walls of the pumping bladder can be designed so various segments sequentially expand and sequentially contract. This emulates the action of the muscular walls of the natural heart and provides a way to model flow through the device similar to flow through the natural heart.
THE THERAPEUTIC APPLICATIONS
Clearly, a major innovation like the ElishaHeart technology will fuel expansion of the use of VADs. In the past, the primary use for VADs has been limited to Bridge-to-Transplant. The second, and far greater application is Destination Therapy for patients with end stage heart failure who are not candidates for heart transplant. These patients can benefit from a permanent, implanted VAD and can live at home and participate in many normal activities. The third and newest area with significant potential and rapidly growing interest is Bridge-to-Recovery. A VAD is implanted to allow the heart to rest while pharmacologic treatment is given to enhance recovery.
Industry sources estimate the potential worldwide demand for VADs at over $2 billion this year and it is expected to grow to between $7.5 billion and $12 billion annually in five years. A significant innovation in the design of VADs and artificial hearts, like the ElishaHeart technology, will determine how rapidly the market reaches its potential.
The ElishaHeart technology has been patented in the United States (US 6,579,223 B2 June 17, 2003) and in Europe (EP 1416877 January 14, 2009). A U.S. patent application has also been filed on other concepts related to the function and development process of the ElishaHeart technology. It is anticipated that additional patents will be filed as development proceeds.
Dr. Arthur S. Palmer, a cardiothoracic surgeon who was affiliated with Northwestern University for over 30 years and a mechanical engineer, created the breakthrough technology. Dr. Palmer has assembled a team of world leaders in multiple disciplines including mathematics, polymer science and engineering to create this truly innovative cardiac assist device. These collaborators are confident that the project is valuable and has a high likelihood of success.
A timeline and budget for development through the first clinical human implantation is available for discussion. For further information, contact Art Tauder at Thunderhouse LLC art@thunderhouse.org or by phone at 212 265 2114.
* The name "ElishaHeart" was derived from a Biblical story of resuscitation -- breathing new life -- from Kings II: Chapter 4.