Pacemakers

Targets and spirals have been observed in the CIMA/CDIMA system [13] and also in dilute flames (i.e. flames close to their lean flammability limits) in situations of enlianced heat loss [33]. In such systems, substantial fiiel is left unbumt. Spiral waves have also been implicated in the onset of cardiac arrhytlnnia [32] the nomial contractive events occurring across the atria in the mannnalian heart are, in some sense, equivalent to a wave pulse initiated from the sino-atrial node, which acts as a pacemaker. If this pulse becomes fragmented, perhaps by passing over a region of heart muscle tissue of lower excitability, then spiral structures (in 3D, these are scroll waves) or re-entrant waves may develop. These have the incorrect... 

Parylene s use in the medical field is linked to electronics. Certain pacemaker manufacturers use it as a protective conformal coating on pacemaker circuitry (69). The coated circuitry is sealed in a metal can, so that the parylene coating serves only as a backup should the primary barrier leak. There is also interest in its use as an electrode insulation in the fabrication of miniature electrodes for long-term implantation to record or to stimulate neurons in the central or peripheral nervous system, as the "front end" of experimental neural prostheses (70). One report describes the 3-yr survival of functioning parylene-coated electrodes in the brain of a monkey (71). 

Safety considerations for magnetic resonance (mr) experiments have received Htde attention except for the problems associated with the use of electronic devices such as pacemakers in the magnetic field. However, in a 1990 study of reproductive health involving more than 1900 women working in clinical mr facihties in the United States no substantial differences were reported between the group of women directly involved with mr equipment (280 individuals) and other working women (894 individuals) (10). Conclusions are restricted to exposure to the static external field. 

Platiaum and its alloys are also used as biomedical electrodes, eg, platiaum—indium wires for permanent and temporary pacemaker leads and defibrillator leads. Electrophysiology catheters, which contain platinum electrodes and marker bands, have been used to map the electrical pathways of the heart so that appropriate treatment, such as a pacemaker, can be prescribed. 

The isotope plutonium-238 [13981 -16-3] Pu, is of technical importance because of the high heat that accompanies its radioactive decay. This isotope has been and is being used as fuel in small terrestrial and space nuclear-powered sources (3,4). Tu-based radioisotope thermal generator systems dehvered 7 W/kg and cost 120,000/W in 1991 (3). For some time, %Pu was considered to be the most promising power source for the radioisotope-powered artificial heart and for cardiovascular pacemakers. Usage of plutonium was discontinued, however, after it was determined that adequate elimination of penetrating radiation was uncertain (5) (see PROSTHETIC AND BIOMEDICAL devices). 

Uses of Plutonium. The fissile isotope Pu had its first use in fission weapons, beginning with the Trinity test at Alamogordo, New Mexico, on July 16, 1945, followed soon thereafter by the "Litde Boy" bomb dropped on Nagasaki on August 9, 1945. Its weapons use was extended as triggers for thermonuclear weapons. This isotope is produced in and consumed as fuel in breeder reactors. The short-Hved isotope Tu has been used in radioisotope electrical generators in unmanned space sateUites, lunar and interplanetary spaceships, heart pacemakers, and (as Tu—Be alloy) neutron sources (23). 

Cardiac Pacemakers and Mechanical Hearts—-A. Bibliography of Radioisotope Power Sources, TID-3336, Technical Information Center, U.S. Atomic Energy Commission, Washington, D.C., 1973. 

Arrhythmias. The first solution to cardiovascular problems arising from arrhythmias came about as a result of a complication caused by open-heart surgery. During procedures to correct congenital defects in children s hearts, the electrical conduction system often became impaired, and until it healed, the heart could not contract sufficiently without outside electrical stimulation. A system that plugged into a wall outlet was considered adequate until an electrical storm knocked out power, lea ding to the development of the first battery-powered external pacemaker. 

The first implantable pacemaker, introduced in 1960, provided a permanent solution to a chronic bradyarrhythmia condition. This invention had a profound impact on the future of medical devices. The pacemaker was the first implantable device which became intrinsic to the body, enabling the patient to lead a normal life. 

Clinical evaluation is underway to test transvenous electrodes. Transvenous leads permit pacemakers to be implanted under local anesthesia while the patient is awake, greatly reducing recovery time and risk. As of 1996, the generation of implantable defibrillators requires a thoracotomy, a surgical opening of the chest, in order to attach electrodes to the outside of the heart. Transvenous electrodes would allow cardiologists to perform pacemaker procedures without a hospital or the use of general anesthesia. 

One of the more intriguing cardiovascular developments is cardiomyoplasty where implantable technologies are blended with another part of the body to take over for a diseased heart. One company, Medtronic, in close collaboration with surgeons, has developed a cardiomyoplasty system to accompany a technique of wrapping back muscle around a diseased heart which can no longer adequately pump. A combination pacemaker and neurological device senses the electrical activity of the heart and correspondingly trains and stimulates the dorsal muscle to cause the defective heart to contract and pump blood. Over 50 implants have been performed to date. 

Fig. 6. A pacemaker provides electrical impulses to the heart in an effort to correct potentially fatal arrhythmias.

Polyurethanes as Biomaterials. Much of the progress in cardiovascular devices can be attributed to advances in preparing biostable polyurethanes. Biostable polycarbonate-based polyurethane materials such as Corethane (9) and ChronoFlex (10) offer far-reaching capabiUties to cardiovascular products. These and other polyurethane materials offer significant advantages for important long-term products, such as implantable ports, hemodialysis, and peripheral catheters pacemaker interfaces and leads and vascular grafts. 

Pacemaker Interfaces and Leads. Problems of existing pacemaker interfaces and pacemaker lead materials made from siUcones and standard polyurethanes are environmental stress cracking, rigidity, insulation properties, and size. 

Worldwide, more than 250,000 cardiac pacemakers were implanted in 1995, accounting for well in excess of 1 biUion in sales. It is estimated that over 500,000 people in the United States alone have pacemakers. Millions of people have been able to lead normal lives thanks to this remarkable device. 

Sohd tantalum capacitors have a high volumetric capacitance which makes them attractive for use in miniaturized electronic systems like cellular telephones, hand-held video cameras, and personal computers. The insensitivity of their capacitance to temperature and their abiUty to operate at temperature extremes explains why these devices are used in such harsh environments as automobile engine compartments. Sohd tantalum capacitors are extremely rehable and, therefore, are often the capacitor of choice in critical appHcations like spacecraft electronics, pacemakers, and safety equipment. 

Because normal radioisotopic decay lowers the thermal output by about 2.5%/yr in these units, they are purposefully overdesigned for beginning of life conditions. Several of these generators have successfully operated for as long as 28 years. This is approximately equal to the half-life of the strontium-90 isotope used in the heat sources. The original SNAP-7 series immobilized the strontium-90 as the titanate, but the more recent ones have used it in the form of the fluoride, which is also very stable. A number of tiny nuclear-powered cardiac pacemaker batteries were developed, which have electrical power outputs of 33—600 p.W and have been proven in use (17). 

In consumer appHcations, titanium is used in golf club heads, jewelry, eyeglass frames, and watches. The Japanese have promoted the use of titanium in roofing and monuments. Other appHcation areas include nuclear-waste storage canisters, pacemaker castings, medical implants, high performance automotive appHcations, and ordnance armor. 

Fig. 24. Cutaway view of lithium—iodine pacemaker ceU in case-grounded, central anode configuration (36).

Automa-ticity. Special cardiac cells, such as SA and AV nodal cells, His-bundle cells, and Purkinje fibers, spontaneously generate an impulse. This is the property of automaticity. Ectopic sites can act as pacemakers if the rate of phase 4 depolarization or resting membrane potential is increased, or the threshold for excitation is reduced. 

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