Artificial Organs

Abstract: The patient submitted to artificial ventilation generally is connected to a high impedance flow source with controlled respiratory cycles to assure volume requirements or to a low impedance pressure source with spontaneous cycles to allow synchronization between his effort and system flow delivery. These two types of cycles represent the initial and final stages of artificial ventilation. The patient who needs a volume guarantee and at the same time presents unstable or insufficient inspiratory effort is difficult to manage with assisted cycles which are analogous to the controlled presence of a high impedance flow source. This paper presents a new approach where the respiratory cycles are obtained by the combination of flow and pressure sources using mathematical modeling. These cycles, named volume assisted pressure supported (VAPS) cycles, are compared with conventional assisted cycles showing a decrease in the patient work of breathing (WOB) during assisted ventilation. The theoretical results have been confirmed by clinical trials.

Surface-coated cardiopulmonary bypass (CPB) has been shown to have excellent biocompatibility during cardiac surgery in adults, but there have been only a few reports demonstrating the efficacy of this coating for congenital cardiac surgery. We tested the efficacy of poly-2-methoxyethylacrylate (PMEA) coating for CPB circuits in congenital cardiac surgery. Eleven operative cases of ventricular septal defect were studied: group C (control: no coating, n = 5) and group P (PMEA coating, n = 6). The platelet count and beta-thromboglobulin (beta TG), fibrinogen (FBG), thrombin-antithrombin complex (TAT), and neutrophil elastase levels were measured during the operation. Postoperative chest tube drainage was analyzed and the surface of the artificial lung was observed with an electron microscope. Elevation of TAT and neutrophil elastase was suppressed in group P (P < 0.05). Observation of the artificial lung surface using an electron microscope clearly revealed fewer blood cells were a...

The CardioWest total artificial heart (TAH) is a pneumatic device that is used as a bridge to heart transplantation and the only TAH available that totally replaces the failing ventricles. It has been utilized in selected centers in the U.S.A. with approval from the Food and Drug Administration. Strict criteria have been developed to select candidates to be bridged with the TAH. The patient must be a heart transplant candidate of age >18 and <59 years with a body surface area (BSA) > or = 1.7 m2, cardiac index (CI) <2.0 L/min/m2, and 2 inotropic agents or 1 plus an intraaortic balloon pump (IABP). A total of 24 heat transplant candidates (Group A) met the entry criteria and underwent placement of the TAH between January 1993 and July 1996. Group A consisted of 23 males; 16 patients had an IABP. The control group (Group B) consisted of 18 heart transplant candidates who met the TAH entry criteria but never received a TAH. Group B consisted of 15 males; 14 patients had an IABP. Preimplantation pulmonary vascular resistance (PVR) (Wood units), serum creatinine (mg/dl), and total bilirubin (mg/dl) were determined in both groups. The mean values for Groups A and B were, respectively, age: 47 and 47 years, BSA: 2.01 and 1.93 m2, CI: 1.5 and 1.8 L/min/m2, PVR: 2.88 and 2.47 Wood units, creatinine: 1.5 and 1.6 mg/dl, and bilirubin: 1.8 and 1.4 mg/dl. In Group A, 1 patient died on the TAH, 1 patient died after transplant, and 22 patients reached transplant and were discharged home for a survival rate of 91.7%. In Group B, 10 patients died while waiting for a heart transplant. Of the 8 patients transplanted, 7 survived and were discharged home for a survival rate of 38.9% (p = 0.0003). In summary the CardioWest TAH provided an excellent and successful method of bridging patients to heart transplantation with a reasonable risk.

Results: Early postoperative mortality (in the first 30 days) was 3.4% (n = 1). The overall estimated Kaplan–Meier survival was 56.7% at 36 months, 46.7% at 60 months, and 43.3% at 96 months. HD program was discontinued for two patients after renal transplantation in the ...

To date, single-needle (SN) hemodialysis (HD) requires a dialysis machine equipped with two blood pumps-one controlling arterial blood flow (Qb) and one controlling venous Qb. B. Braun has developed an innovative single-pump SN HD system. Therefore, usability is improved by reducing complexity. The aim of this study was to compare dialysis parameters of the new single-pump SN HD system with a double-pump SN HD system available on the market (Fresenius Medical Care [FMC] 5008). In this two-armed crossover study, patients were randomized into two groups (B. Braun - FMC/FMC - B. Braun). Study period was 2 weeks (6 HD sessions) for each SN HD system. Both B. Braun and FMC dialysis machines were operated in the single-needle auto mode. With the FMC dialysis machines, Qb was optimized manually, whereas for B. Braun machines it was optimized automatically using the auto-mode functionality. A phase volume of 25 mL, treatment time, needle type and size, and dialyzer type and size were kept c...

Thrombosis inside the membrane oxygenator (MO) is a critical complication during venovenous extracorporeal membrane oxygenation (ECMO). The aim of this study was to prove if thrombotic clots manifest within the MO when D-dimer levels are elevated over a long-term period. Heparin-coated polymethylpentene MOs (n = 13) were exchanged due to high plasma D-dimer levels. Clot volume was calculated using multidetector computed tomography (MDCT). Coagulation parameters and MO function were analyzed before and after MO exchange. Before MO exchange, D-dimer levels increased significantly in each patient (11.5 [6.5-15.5] mg/L to 35.0 [34-35] mg/L, P ≤ 0.001). High levels of D-dimers were tolerated for 1 to 6 days. Additionally, fibrinogen concentration (n = 8) and platelet count decreased (n = 8). Within 48 h after exchange, D-dimer levels decreased significantly (n = 11, 12 [8-16] mg/L, P = 0.004). Fibrinogen concentration and platelet counts increased. Clots were found in all MOs in the inle...

Spasticity has been successfully managed with different treatment modalities or combinations. No information is available on the effectiveness or individual contribution of botulinum toxin type A (BTA) combined with physical and occupational therapy and neuromuscular electrical stimulation to treat spastic upper limb. The purpose of this study was to assess the effects of such treatment and to inform sample-size calculations for a randomized controlled trial. BTA was injected into spastic upper limb muscles of 10 children. They received 10 sessions of physical and occupational therapy followed by 10 sessions of neuromuscular electrical stimulation on the wrist extensors (antagonist muscles). Degree of spasticity using the Modified Ashworth scale, active range of motion, and manual function with the Jebsen hand test, were assessed. Meaningful improvement was observed in hand function posttreatment (P = 0.03). Median spasticity showed a reduction trend and median amplitude of wrist range of motion registered an increase; however, neither of these were significant (P > 0.05). There is evidence of a beneficial effect of the combined treatment. Adequate information has been obtained on main outcome-measurement variability for calculating sample size for a subsequent study to quantify the treatment effect precisely.

Our aim was to evaluate the potential use of zirconium oxide (zirconia) as a blood journal bearing material in the DexAide right ventricular assist device. The DexAide titanium stator was replaced by a zirconia stator in several blood pump builds, without changing the remaining pump hardware components. In vitro pump performance and efficiency were evaluated at a predetermined pump speed and flow. Motor power consumption decreased by 20%, and DexAide battery life was extended to over 12 h on two fully charged batteries. The zirconia stator was also successfully evaluated in a severe start/stop test pre- and postexposure of the zirconia to accelerated simulated biologic aging. This study's outcomes indicated the advantages of zirconia as an alternate journal bearing material for the DexAide device.

Abstract: Polyvinylidene fluoride (PVDF) represents an attractive alternative to polypropylene as a monofilament vascular suture because of its satisfactory physicochemical properties, its ease of handling, and its good biocompatibility. However, the polymer's ability to remain mechanically and chemically stable when exposed to a mild hydrolytic environment over the long term has yet to be demonstrated. One in vitro study involved the comparison of the long-term relative resistance of PVDF and polypropylene sutures to hydrolysis for a period of 9 years. The PVDF suture showed major molecular rearrangements from the original ratio of three crystalline structures to the single β crystalline phase. The observation of some surface oxidation and water imbibition did not significantly modify the tensile strength of the PVDF suture, which retained 92.5% of its original value. In contrast, the polypropylene sample did not undergo any recrystallization but was associated with more oxidation byproducts and more water molecules near the surface, which contributed to a 46.6% loss in initial tensile strength. An in vivo study confirmed that PVDF sutures are biocompatible and are able to maintain satisfactory biostability when used to anastomose thoracic aortic allografts for a period of 6 months in the dog. The cellular reaction of fresh allografts as well as the control autografts to PVDF sutures was minimal. In other allografts that had been preserved in a supplemented medium for 1 week prior to implantation, the PVDF sutures healed satisfactorily with the formation of neocollagen and few macrophages surrounding the monofilament. No evidence of instability at the allograft-host artery junction was observed, confirming that the PVDF sutures were able to ensure a secure anastomosis in the thoracic aorta. PVDF sutures have demonstrated superior long-term biostability in vitro and minimal tissue response in vivo. These are two essential requirements when evaluating the use of a suture for vascular surgery in general and thoracic aortic surgery in particular

Several studies have reported the asynchronous closure of normal bileaflet valves (NBVs), resulting in a split in its closing sound; however, the clinical significance of this split has never been studied in malfunctioning bileaflet valves (MBVs). The study comprised 218 valves in 184 patients, including normal monoleaflet valves (n = 10), NBVs (n = 198), and MBVs (n = 10). Valve function was confirmed by cinefluoroscopy prior to analysis of the valve sound by the Morlet continuous wavelet transform (CWT). The split interval (SI) for each heartbeat was measured, and the coefficient of variation (CV) of its mean (valve SI) was calculated as a parameter for the fluctuation of the SI. The CWT of monoleaflet valves showed a single spike, whereas NBVs exhibited a clear split. There was no significant difference in valve SI between the aortic and mitral positions; however, the mean of the CV was significantly greater in the mitral position (n = 90, 0.507 +/- 0.254) than in aortic position...

This study proposes a new method to determine the mechanical properties of human skin by the use of the indentation test [Pailler-Mattei, 2004. Caractérisation mécanique et tribologique de la peau humaine in vivo, Ph.D. Thesis, ECL-no. 2004-31; Pailler-Mattei, Zahouani, 2004. Journal of Adhesion Science and Technology 18, 1739-1758]. The principle of the measurements consists in applying an in vivo compressive stress [Zhang et al., 1994. Proceedings of the Institution of Mechanical Engineers 208, 217-222; Bosboom et al., 2001. Journal of Biomechanics 34, 1365-1368; Oomens et al., 1984. Selected Proceedings of Meetings of European Society of Biomechanics, pp. 227-232; Oomens et al., 1987. Journal of Biomechanics 20(9), 877-885] on the skin tissue of an individual's forearm. These measurements show an increase in the normal contact force as a function of the indentation depth. The interpretation of such results usually requires a long and tedious phenomenological study. We propose a new method to determine the mechanical parameters which control the response of skin tissue. This method is threefold: experimental, numerical, and comparative. It consists combining experimental results with a numerical finite elements model in order to find out the required parameters. This process uses a scheme of extended Kalman filters (EKF) [Gu et al., 2003. Materials Science and Engineering A345, 223-233; Nakamura et al., 2000. Acta Mater 48, 4293-4306; Leustean and Rosu, 2003. Certifying Kalman filters. RIACS Technical Report 03.02, 27pp. http://gureni.cs.uiuc.edu/~grosu/download/luta + leo.pdf; Welch and Bishop, An introduction to Kalman filter, University of North Carolina at Chapel Hill, 16p. http://www.cs.unc.edu/~welch/kalman/]. The first results presented in this study correspond to a simplified numerical modeling of the global system. The skin is assumed to be a semi-infinite layer with an isotropic linear elastic mechanical behavior [Zhang et al., 1994. Proceedings of the Institution of Mechanical Engineers 208, 217-222] This analysis will be extended to more realistic models in further works.