Charles R. Davies

Experimental and clinical evaluation of a noninvasive reflectance pulse oximeter sensor

The objective of this study was to evaluate a new reflectance pulse oximeter sensor. The prototype sensor consists of 8 light-emitting diode (LED) chips (4 at 665 nm and 4 at 820 nm) and a photodiode chip mounted on a single substrate. The 4 LED chips for each wavelength are spaced at 90-degree intervals around the substrate and at an equal radial distance from the photodiode chip. An optical barrier between the photodiode and LED chips prevents a direct coupling effect between them. Near-infrared LEDs (940 nm) in the sensor warm the tissue. The microthermocouple mounted on the sensor surface measures the temperature of the skin-sensor interface and maintains it at a preset level by servoregulating the current in the 940-nm LEDs. An animal study and a clinical study were performed. In the animal study, 5 mongrel dogs (weight, 10–20 kg) were anesthetized, mechanically ventilated, and cannulated. In each animal, arterial oxygen saturation (SaO2) was measured continuously by a standard transmission oximeter probe placed on the dogs earlobe and a reflectance oximeter sensor placed on the dogs tongue. In the first phase of the experiment, signals from the reflectance sensor were recorded while the dog was immersed in ice water until its body temperature decreased to 30°C. In the second phase, the animals body temperature was normal, and the oxygen content of the ventilator was varied to alter the SaO2. In the clinical study, 18 critically ill patients were monitored perioperatively with the prototype reflectance sensor. The first phase of the study investigated the relationship between local skin temperature and the accuracy of oximeter readings with the reflectance sensor. Each measurement was taken at a high saturation level as a function of local skin temperature. The second phase of the study compared measurements of oxygen saturation by a reflectance oximeter (SpO2[r]) with those made by a co-oximeter (SaO2[IL]) and a standard transmission oximeter (SpO2[t]). Linear regression analysis was used to determine the degree of correlation between (1) the pulse amplitude and skin temperature; (2) SpO2(r) and SaO2(IL); and (3) SpO2(t) and SaO2(IL). Studentst test was used to determine the significance of each correlation. The mean and standard deviation of the differences were also computed. In the animal study, pulse amplitude levels increased concomitantly with skin temperature (at 665 nm,r=0.9424; at 820 nm,r=0.9834;p<0.001) and SpO2(r) correlated well with SaO2(IL) (r=0.982; SEE=2.54%;p<0.001). The results of the clinical study are consistent with these findings. The proto-type reflectance pulse oximeter sensor can yield accurate measurements of oxygen saturation when applied to the forehead or cheek. It is, therefore, an effective alternative to transmission oximeters for perioperative monitoring of critically ill patients.

Adaptation of Tissue to a Chronic Heat Load

Determination of the chronic effect of heat on tissue is one of the important issues facing mechanically actuated total artificial heart (TAH) development. In an effort to characterize this effect, implantations of heating devices producing constant heat fluxes of 0.04 watts/cm2, 0.06 W/cm2, and 0.08 W/cm2 were performed in 11 calves (H-series). Heated disks were implanted adjacent to lung and muscle tissue for a period of 7 weeks. Temperature sensors were placed at the surface as part of the heater assemblies. The results showed that initially, temperature elevations above body temperature (delta T) were 6.4 +/- 0.6 degrees C, 4.5 +/- 0.2 degrees C, and 1.8 +/- 0.5 degrees C at the muscle heater surface for 0.08, 0.06, and 0.04 W/cm2, respectively. At 2 weeks after implant delta T values changed to 5.5 +/- 0.6 degrees C, 3.4 +/- 0.2 degrees C, and 1.8 +/- 0.2 degrees C, respectively. Seven weeks after implant, delta T values decreased to 3.7 +/- 1.2 degrees C, 2.8 +/- 0.1 degrees C, and 0.8 degrees C for 0.08, 0.06, and 0.04 W/cm2, respectively. The authors think this change is attributable to an adaptive response of the tissue to increase heat dissipation through angiogenesis. Results from three TAH cases indicated that at two measured tissue interfaces, delta T decreased by 1 degrees C during a 15 day period. At the same time, the waste heat (volts x current in-flow x afterload to the blood) remained constant at 11.1 +/- 0.5 W during this period. This decrease in delta T corresponded to that observed for the H-series experiments at the higher heat fluxes. Thus, it appears that adaptation observed in the H-series experiments also is seen for tissues surrounding heat sources such as the TAH.

Development of a magnetically operated artificial urethral sphincter : chronic effects of compression on the skin structure and blood flow

Hierarchical hybrid vascular grafts were constructed with an endothelial cell (EC) monolayer and hybrid medial layer composed of smooth muscle cells (SMCs) and type I collagen gel. The grafts, implanted into canine carotid arteries for up to 12 weeks, were ultrastructurally examined with a transmission electron microscope. Before implantation, SMCs incorporated into hybrid media were round and intracellularly filled with synthetic organelles such as rough endoplasmic reticula, mitochondria, free ribosomes, and Golgi complexes. Two weeks after implantation, bipolar spindle shaped SMCs still remained in a synthetic phenotype. At 12 weeks, circumferentially aligned SMCs were abundant in contractile apparatus such as myofilaments, dense bodies, and basement membranes. In a morphometric evaluation, the populations of three phenotypic SMCs (synthetic, intermediate, and contractile SMCs) were quantified. At 2 weeks, the proportions were 50.5, 41.8, and 7.7% for synthetic, intermediate, and contractile phenotypes, respectively. At 12 weeks, they were 9.9, 26.2, and 63.8%. These findings indicated that SMCs incorporated into hybrid grafts were transformed from a synthetic to a contractile phenotype under pulsatile stressed conditions after 12 weeks in vivo. Thus, the intima/media incorporated hybrid graft reconstructed a vessel wall similar to a native one in terms of structure and function.

Progress in Cleveland Clinic-Nimbus total artificial heart development

A totally implantable, Cleveland Clinic-Nimbus total artificial heart (TAH) uses electrohydraulic energy conversion and an automatic left master-alternate mode control scheme, with a filling sensitivity of 1.0 l/min/mmHg and a maximum output of 9.5 l/min. The TAHs were tested in 12 calves for 1-120 days with normal major organ and blood cell function. Post-operative suppression of platelet aggregation recovered by the second post-operative week. The gelatin-coated pump surface generally was clean without any anticoagulants and free from infection. Embolism, which occurred in two cases, was caused by complications attributable to fungal infection in a Dacron graft and by thrombus formed around a jugular vein catheter. A system with a hybridized microcircuit controller in the interventricular space has been tested successfully in the three most recent cases, with a peak device surface temperature elevation of 6.5 degrees C. Heat effects were confined to the tissues immediately adjacent to the hottest spots. The carbon fiber-reinforced epoxy housing and 60 ml butyl rubber compliance chamber showed good tissue compatibility with a thin, fibrous tissue capsule. The transcutaneous energy transmission system and the internal battery functioned well as designed in the most recent animal implant.

Muscle powered circulatory assist device for diastolic counterpulsator.

A diastolic counterpulsator that uses either skeletal muscle or pneumatic actuation was developed. The unit is positioned between the latissimus dorsi and the chest wall, without interference with collateral blood supply, and is connected in series with the descending aorta. The system was able to generate stroke volumes between 52 and 16 ccs against pressures of 60 and 140 mmHg, respectively. Stroke work at 200 msec stimulation averaged 2.8 X 10(6) ergs. Power output at an afterload of 100 mmHg, and at a rate of 60 bpm, was 0.51 W. Back-up pneumatic actuation provided by an intraaortic balloon pump resulted in a 46% increase in the endocardial viability ratio (EVR).

An Artificial Myotatic Reflex: A Potential Avenue to Fine Motor Control

When a striated muscle becomes paralyzed, not only its motor function, but its sensory innervation may be Impaired. Methods of rehabilitation have previously focused only on motor innervation, although striated muscles are submitted to self-regulation of length and tension. Indeed, reinnervated muscle may not contract appropriately unless sensory information is available, nor is it known whether sensory receptors are included in the reinnervation process. We hypothesized that the myotatic reflex (MR) would be absent in the event these sensory organs are not reinnervated, and that an artificial myotatic reflex (AMR) would be useful in reestablishing fine motor control. The strap muscles were exposed in six anesthetized rabbits. The MR was verified by stretching an intact sternohyoid muscle. Next, loss of the reflex was documented after the ipsllateral ansa hypoglossl was divided, and a crossover nerve-muscle pedicle (NMP) was brought In from the opposite sternothyroid. After 3 months, the MR was still absent; however, stretch of the contralateral sternohyoid produced a reflex response on the reinnervated side. A strain gauge sutured to the reinnervated muscle was linked to an electronic modulator so that stretch induced electric stimulation of the NMP and contraction (the AMR). We conclude that (1) proprioception is not reestablished in the reinnervated muscle; (2) by contrast, sensory Information from the muscle of origin of the NMP Is conveyed to the reinnervated side; and (3) the AMR offers promise toward more sophisticated control of paralyzed (I.e., facial, laryngeal) musculature.

Excitation thresholds for nerve pedicles: A preliminary report

Ongoing Interest in the rehabilitation of paralyzed musculature in the head and neck has focused on the electronic stimulation of nerve-muscle pedicles that have been relmplanted Into the Incapacitated effector(s). Despite visual and histochemical evidence of reinnervation, It Is still not known whether the excitability of a nerve-muscle pedicle (or for that matter a direct nerve Implant) Is equivalent to or better than that of reinnervated or normal muscle. Such Information Is necessary for the eventual construction of an Implantable stimulator. Eighteen rabbits were anesthetized with Intramuscular xylazine and ketamine and the ansa hypoglossi nerve was cut on one side. A crossover nerve-muscle pedicle was brought in from the opposite sternothyroid muscle to the sternohyoid in nine animals; the other nine received a direct nerve Implant. After a minimum neurotization period of 3 months and reexploration, an electrical stimulator capable of delivering square wave pulses of variable amplitude and width was used to determine the thresholds of contraction of the nerve pedicles, an Intact motor nerve of similar size, a normal muscle, and the relnnervated strap In 16 evaluable rabbits. Strength duration curves were established. The data Indicate that thresholds for nerve pedicles are equivalent to those of normal nerves and are significantly lower than those of muscle.

Electronic integration of glottic closure and cricopharyngealrelaxation for the control of aspiration: A canine study☆☆☆★

Aspiration can result from muscular weakness or paralysis of laryngopharyngeal muscles after lower motor neuron disorders (e.g., stroke) or unchecked gastroesophageal reflux. We submit that rehabilitation of the finely tuned swallowing mechanism should provide at least restoration of the normal dynamic relationships between glottic closure and cricopharyngeal relaxation. In three dogs under general endotracheal anesthesia, the recurrent laryngeal nerves and the pharyngeal musculature were exposed through a midline cervical incision. A tracheotomy was performed to allow unhindered laryngoscopic exposure of the vocal cords. A no. 9 endotracheal tube passed through the upper esophageal sphincter was used as a pressure transducer by saline inflation of its cuff and linked to an oscilloscope. The cricopharyngeus was placed under baseline tension with pulse trains administered by an intramuscular needle with a circuit previously used for agonist/antagonist coupling of reinnervated facial musculature. A second output channel was linked to the contralateral recurrent laryngeal nerve by a bipolar electrode. As the pulse width of the current to the recurrent laryngeal nerve increased, that to the cricopharyngeus was reciprocally decreased, producing snug glottic closure and synchronous cricopharyngeal relaxation. Results were documented on videotape. These findings were highly reproducible. We believe that the novel approach proposed in the current model offers an attractive solution to long-term aspiration problems resulting from an imbalance between vocal cord and cricopharyngeal activities.

Artificial restoration of voice. I: Experiments in phonatory control of the reinnervated canine larynx

Coordinated electronic pacing of implanted nerve pedicles into paralyzed laryngeal muscles has allowed selective dynamic control of abduction, adduction, and elongation of the vocal cords. Modifications of the original circuit in a cervical muscle model has added fine tuning to basic “all‐or‐none” pacing. Rehabilitation of phonation illustrated the sophisticated nature of voice and the need for restoration of fine tuning. Five mongrel dogs received nerve‐muscle pedicles into the thyroarytenoideus, cricothyroideus, and posterior cricothyroideus after denervation of one hemilarynx. Following appropriate reinnervation time, pedicles and intact recurrent laryngeal nerves were injected with currents of variable amplitudes and pulse widths to achieve graded vocal fold control while air was blown intratracheal‐ly towards the glottic chink. Videoscopic and spectral analyses indicated that artificial phonation could be restored to frequencies measured in the normal state. These experiments suggested that rehabilitation of the impaired voice by servocontrol might eventually be feasible.

Heat from an implanted power source is mainly dissipated by blood perfusion.

Heat dissipation and its effects on tissue and blood interfaces are common problems associated with the development and increased use of artificial hearts, because all of the implantable actuators for artificial hearts generate waste heat due to inefficiencies of energy conversion. To determine the mechanisms of heat dissipation from artificial hearts, heated disks producing constant heat fluxes of 0.08 watts/cm2 were implanted adjacent to the left lung and the latissimus dorsi muscle in calves for 2 weeks, 4 weeks, and 7 weeks. At the end of each experiment, a series of acute studies was performed in which blood perfusion to the heated tissue was decreased or stopped to observe the contribution of blood perfusion to heat dissipation. The cooling effect of ventilation was also examined to determine its relative contribution to heat dissipation in lung tissue by decreasing the minute ventilation volume. The importance of blood perfusion for heat dissipation was demonstrated by the temperature rise after cessation of blood perfusion to the heated tissue. The contribution of ventilation to heat dissipation in the heated lung tissue was minimal. Contribution of total blood perfusion to heat dissipation was increased with time in the muscle tissue, which has relatively low resting blood perfusion, but not in the lung tissue, which has relatively high blood perfusion. In the heated muscle tissue, the in vivo adaptive response to chronic heat was functionally shown by the increased perfusion. In conclusion, blood perfusion was the main mechanism of heat dissipation from tissues that were adjacent to an implanted power source. ASAIO Journal 1997; 43:M585-M588.