Sequence and task analysis of instrument use in common laparoscopic procedures.

BACKGROUND: In the area of instrument evaluation, one aspect that still requires objective assessment is the dynamics of instrument maneuver and exchange. If we could gain a better understanding of these phenomena, we could improve the design of the instruments themselves. METHODS: A total of 29 laparoscopic procedures were videotaped and reviewed using time motion analysis. Instrument multifunctionality was determined using a standardized list of laparoscopic maneuvers. State transition diagrams were utilized to document the sequence of instrument exchanges. RESULTS: The curved dissector, atraumatic grasper, and cautery scissors were identified as the most multifunctional instruments; each was able to perform five distinct maneuvers. Instrument sequences were found to consist of a three-part dissect --> clip --> cut cycle and a two-part dissect --> suction cycle of instrument exchange. CONCLUSION: This study demonstrated that laparoscopic instruments are often used to perform a variety of maneuvers in addition to their primary function. Furthermore, there are common patterns in instrument exchange that provide a potential source of design parameters for improved surgical efficiency.

A virtual reality surgical trainer for navigation in laparoscopic surgery.

A virtual reality trainer was designed to familiarize students and surgeons with surgical navigation using an angled laparoscopic lens and camera system. Previous laparoscopic trainers have been devoted to task or procedure training. Our system is exclusively devoted to laparoscope manipulation and navigation. Laparoscopic experts scored better than novices in this system suggesting construct validity. The trainer received favorable subjective ratings. This simulator may provide for improved navigation in the operating room and become a useful tool for residents and practicing surgeons.

Modifications in surgical implantation of the Penn State electric total artificial heart.

BACKGROUND: Two modifications of the surgical implantation protocol for the Penn State Total Artificial Heart (ETAH) were evaluated: Phrenic nerve ischemia was prevented by minimizing dissection and traction; and hemostasis was augmented and ETAH cuff anastomoses reinforced by using fibrin glue. METHODS: Thirteen Holstein calves underwent orthotopic surgical implantation of the Penn State ETAH between February 1998 and August 2000. Mean hemodynamic and laboratory chemistry variables from the first postoperative week were compared between calves receiving the original (n = 7) and modified (n = 6) protocol. RESULTS: Calves assigned to the modified protocol displayed an improvement in the Po2/FiO2 ratio compared to original (419.4 +/- 17.5 vs 336.3 +/- 35.4, respectively; p = 0.05). All additional parameters were equivalent between groups. The percent survival of animals receiving the modified protocol at 2, 4, and 12 weeks was higher than that of animals that underwent the original protocol. Original-protocol calf deaths consisting of hemothorax (n = 3), and respiratory failure (n = 1) were prevented in the modified protocol. CONCLUSIONS: Our results suggest that manipulations in surgical protocol may promote increased survival in calves implanted with the Penn State ETAH.

The LionHeart LVD-2000: a completely implanted left ventricular assist device for chronic circulatory support.

Management of patients with end-stage cardiac disease remains a vexing problem. Limitations in medical management and a fixed supply of donor organs for cardiac transplant have a continued impact on this growing population of patients. Mechanical circulatory support has proved very successful as a means of bridging patients to cardiac transplant when all medical options have been exhausted. The development of a chronic system of circulatory support has been underway at the Pennsylvania State University for nearly 30 years. These efforts have been recently merged with the industrial partnership with Arrow International toward the development of the LionHeart LVD-2000 (Arrow International, Reading, PA) completely implanted left ventricular support system. We present an overview of the system, details of implantation, a review of preclinical studies, and a synopsis of the first European implants. Early results have demonstrated the system to be safe, effective, and reliable. Transcutaneous energy transmission and the compliance chamber have been validated.

Testing of a 50 cc stroke volume completely implantable artificial heart: expanding chronic mechanical circulatory support to women, adolescents, and small stature men.

The development of a completely implanted total artificial heart at our institution has progressed to successful in vivo and in vitro testing of a device that is nearing clinical testing. This system consists of a 70 cc stroke volume pump originally designed to be used in men of average stature. Implantation of this system remains limited by patient size; hence, many women and adolescent patients will likely be precluded from support because of their smaller stature. A system similar in design, but with a 50 cc stroke volume pump has been developed. The first in vivo study of this device has been undertaken. A calf was supported for 33 days. The animal was extubated and ambulatory within the first 6 hours of implantation, and remained healthy until the thirty-third postoperative day when it suffered an embolic neurologic event. The pump and operating system worked flawlessly throughout the period of support. Further in vivo and in vitro testing will be undertaken. Development of a scaled down total artificial heart system expands this type of circulatory support to those critically ill patients previously deemed poor candidates because of their smaller body habitus.

Carotid and aortic baroreflexes of the rat: II. Open-loop frequency response and the blood pressure spectrum.

To determine the relationship between blood pressure (BP) variability and the open-loop frequency domain transfer function (TF) of the baroreflexes, we measured the pre- and postsinoaortic denervation (SAD) spectra and the effects of periodic and step inputs to the aortic depressor nerve and isolated carotid sinus of central nervous system-intact, neuromuscular-blocked (NMB) rats. Similar to previous results in freely moving rats, SAD greatly increased very low frequency (VLF) (0.01-0.2 Hz) systolic blood pressure (SBP) noise power. Step response-frequency measurements for SBP; interbeat interval (IBI); venous pressure; mesenteric, femoral, and skin blood flow; and direct modulation analyses of SBP showed that only VLF variability could be substantially attenuated by an intact baroreflex. The -3-dB frequency for SBP is 0.035-0.056 Hz; femoral vascular conductance is similar to SBP, but mesenteric vascular conductance has a reliably lower and IBI has a reliably higher -3-dB point. The overall open-loop transportation lag, of which

In vivo and in vitro stability of modified poly(urethaneurea) blood sacs.

In the present study, we investigate the in vivo and in vitro stability of modified poly(urethaneurea) (BioSpan MS/0.4) blood sacs. Blood sacs were utilized primarily in left ventricular assist devices that were implanted in calves for times ranging from 5 to 160 days. Cyclic testing in vitro was also conducted on similar sacs. Various analytical methods were employed to characterize the sacs after in vivo or in vitro service and corresponding retained "control" sacs. These methods included ATR-FTIR spectroscopy, scanning electron microscopy and gel permeation chromatography. In general, the characteristics of implanted and in vitro cycled sacs were similar to their control sacs. Thermal and microtensile properties were unchanged after testing. The same was true for the ATR-FTIR spectra, indicating relative chemical stability for the time frames explored here. The only significant changes occurred in molecular weight and gross surface morphology. A modest increase in weight average molecular weight was observed for most implanted blood sacs, indicating some type of chain extension or branching reaction in vivo. Although the surface morphologies of implanted blood sacs were often similar to their control sacs, we sometimes observed limited pitting on the nonblood contacting surfaces in regions of the sac that experience maximum bending during service.

An investigation of the in vivo stability of poly(ether urethaneurea) blood sacs.

In this paper we investigate the biostability of a series of Biolon blood sacs that were utilized in electric total artificial hearts for time periods of up to 19 weeks. A battery of experimental probes, including scanning electron microscopy (SEM) and X-ray photoelectron spectroscopy (XPS), were used to characterize the bulk and surface properties of explanted and control blood sacs. Gel permeation chromatography (GPC) experiments showed that generally there was a dramatic increase in average molecular weight at longer implantation times. However, SEM and GPC observations suggest significant deterioration of the flex regions of right blood sacs after 17 weeks of service. XPS experiments indicated appreciable silicon and hydrocarbon concentrations on blood-contacting surfaces both before and after implantation, and we speculate as to their origin.

Steady state hemodynamic and energetic characterization of the Penn State/3M Health Care Total Artificial Heart.

Total Artificial Heart (TAH) development at Penn State University and 3M Health Care has progressed from design improvements and manufacturing documentation to in vitro and in vivo testing to characterize the system's hemodynamic response and energetic performance. The TAH system is completely implantable and intended for use as an alternative to transplantation. It includes a dual pusher plate pump and rollerscrew actuator, welded electronics and battery assembly, transcutaneous energy transmission system, telemetry, and a compliance chamber. In vitro testing was conducted on a Penn State mock circulatory loop with glycerol/water solution at body temperature. Tests were performed to characterize the preload and afterload response, left atrial pressure control, and power consumption. A sensitive preload response was demonstrated with left atrial pressure safely maintained at less than 15 mm Hg for flow rates up to 7.5 L/min. Variations in aortic pressure and pulmonary vascular resistance were found to have minimal effects on the preload sensitivity and left atrial pressure control. In vivo testing of the completely implanted system in its final configuration was carried out in two acute studies using implanted temperature sensors mounted on the electronics, motor, and energy transmission coil in contact with adjacent tissue. The mean temperature at the device-tissue interface was less than 4 degrees C above core temperature.

Postoperative pulmonary complications in calves after implantation of an electric total artificial heart.

In long-term studies testing the Penn State Total Artificial Heart involving 30 calves, seven calves died of pulmonary complications within 2 weeks after receiving the implant (Group 1 [G1]) and seven calves survived from 2 weeks to 3 months without infection (Group 2 [G2]). Comparative studies were performed using multiple variables: cardiopulmonary bypass (CPB) time, cardiac index, central venous pressure, leukocyte count, hematocrit, total protein, albumin, serum glutamic oxaloacetic transaminase (GOT), creatinine, water balance, and transfused blood volume. In G1, CPB time was longer than in G2 (182 +/- 19 vs 156 +/- 17 minutes, respectively, p = 0.018). Postoperative minimum total protein and albumin in G1 were lower than those in G2 (56.5% +/- 6.0% and 59.0% +/- 5.5% of preoperative values vs 68.4% +/- 8.5% and 67.8% +/- 6.1%, respectively, p = 0.011 and 0.015). Water balance in G2 was more positive than in G1 (11.7 +/- 6.8 vs 1.4 +/- 8.3 L, respectively, p = 0.020). Other variables showed no significant differences. Microscopic findings of the lung in G1 were congestion, hemorrhage, aggregation of neutrophils, and proteinaceous material within the interstitial tissues and alveoli.

Physiological control of a total artificial heart: conductance- and arterial pressure-based control.

To obtain a physiological response by a total artificial heart (TAH), while eliminating the hemodynamic abnormalities commonly observed with its use, we proposed the use of a conductance- and arterial pressure-based method (1/R control) to determine TAH cardiac output. In this study, we endeavored to make use of a variable more closely tied to central nervous system (CNS) efferents, systemic conductance, to provide the CNS with more direct control over the output of the TAH. The control equation that calculates the target cardiac output of the TAH was constructed on the basis of measurement of blood pressures and TAH flow. The 1/R control method was tested in TAH-recipient goats with an automatic method by using a microcomputer. In 1/R control animals, the typical TAH pathologies, such as mild arterial hypertension and substantial systemic venous hypertension, did not occur. Cardiac output varied according to daily activity level and exercise in a manner similar to that observed in natural heart goats. These results indicate that we have determined a control method for the TAH that avoids hemodynamic abnormalities exhibited by other TAH control systems and that exhibits physiological responses to exercise and daily activities under the conditions tested. The stability of the control and the complete lack of inappropriate excursions in cardiac output is suggestive of CNS involvement in stabilizing the system.

Dynamic in vitro and in vivo performance of a permanent total artificial heart.

In vivo characterization studies were performed to compare the dynamic in vivo performance of the Penn State/3M Health Care electric total artificial heart to existing in vitro data. Fully implanted systems were utilized including the artificial heart, controller, backup batteries, compliance chamber, and transcutaneous energy transmission. Catheters were implanted to measure central venous pressure (CVP), left atrial pressure (LAP), right atrial pressure (RAP), pulmonary artery pressure (PAP), and aortic pressure (AoP). Cardiac output (CO) was determined from the implanted controller, and systemic vascular resistance (SVR) was calculated. Steady state data were collected for each animal along with data regarding the transient responses to changes in preload and afterload. Preload was manipulated through volume changes. Afterload changes were accomplished through vasoactive agents. Increased preload caused little change in cardiac output because the pump output was nearly maximum at baseline. LAP, AoP, and SVR increased with increasing RAP. Decreased preload caused a reduction in CO, LAP, and SVR. Afterload increase resulted in a slight decrease in flow and an increase in system power and SVR. Afterload reduction was accompanied by a decrease in preload and a concomitant reduction in flow. Overall, the system response was similar to the response observed in vitro.

Recent improvements in a completely implanted total artificial heart.

The total artificial heart under development by the Pennsylvania State University and 3M Health Care has undergone a number of design improvements to improve reliability, manufacturability, implantability, and performance. These improvements are nearing completion in preparation for formal durability testing. The redesigned implanted electronics canister, consisting of a welded titanium shell with hermetic connectors, contains the control, telemetry, and energy transmission electronics, as well as a 9 cell, 800 mAhr Ni-Cd battery pack. Functional changes include a reduction in the battery recharge time from 14 hours to 4 hours, and a new inductive telemetry system. The energy transmission system operating frequency has been increased from 160 kHz to 200 kHz. Electromagnetic interference filters and a more efficient control mode have also been implemented. The energy converter has been modified to incorporate a new motor with integral Hall effect position sensors, and new cable, and compliance chamber conduit fittings. High flex life cable is now used for the motor and coil cables. Two prototype durability mock circulatory loops have been built and are being tested. Substantial progress has been made in the completion of manufacturing documentation, and in the implementation of a quality system.

In vivo testing of a completely implanted total artificial heart system.

The authors performed 14 implants of a completely implanted total artificial heart (TAH) system in calves. The system consisted of a dual pusher plate rollerscrew energy converter, two sac type blood pumps, an implanted electronic control and battery package, and a transcutaneous energy transmission system. Ten of the implants included a percutaneous lead for monitoring of the implant; the remainder made use of wireless two way telemetry between the implant and the outside. Three animals survived the perioperative period. These calves survived for 98 to 118 days, and one was still alive at 150 days. Causes for termination of the 98 and 118 day cases were abdominal pocket sepsis originating at a monitoring line, and systemic sepsis acquired perioperatively. Death or termination in the shorter cases was mainly due to respiratory complications or bleeding. The TAH system proved capable of providing adequate cardiac outputs at modest atrial pressures. Wireless monitoring and wireless intervention for weaning from cardiopulmonary bypass were readily achieved. All organ systems functioned normally in the presence of the device. Once recovery from implantation in these very young animals was achieved, the system proved its ability to reliably support these animals until body mass exceeded its cardiac output capabilities.

An annular compliance chamber for the Pennsylvania State University electric total artificial heart.

To eliminate the need for a separate parapleural compliance chamber, we are currently investigating the feasibility of an annular compliance chamber. This chamber wraps around the energy converter and fits between the blood pumps of the Pennsylvania State University electric total artificial heart. For the 100 cc total artificial heart, the compliance chamber volume is 76 ml and the tissue contacting surface area is approximately 85 cm2. The chamber is made of Dacron velour covered segmented polyether polyurethane urea. The annular compliance chamber was evaluated in vitro by comparing pump balance control performance against that obtained with an open vent. In the CVP range of 5-12 mmHg, LAP was maintained within 1 mmHg of the values obtained with a vent. Studies continue to determine the range of volumes over which the chamber is effective, differences in rates of diffusion, and performance during changes in barometric pressure.

A completely implanted left ventricular assist device. Chronic in vivo testing.

A completely implantable left ventricular assist device (LVAD) designed for permanent circulatory support has recently been tested in animals without the use of percutaneous leads, using transcutaneous energy transmission and wireless telemetry. The LVAD consists of a brushless DC motor and rollerscrew energy converter, a pusher plate actuated blood pump with a seamless segmented polyurethane blood sac, Bjork-Shiley Delrin disk monostrut valves, an implanted compliance chamber, an implanted electronic controller and battery, and a transcutaneous energy transmission system. The blood pump/energy converter assembly weighs 565 g and displaces 295 cc. The dynamic stroke volume is 60 ml, and the maximum output is 9 L/min. Pump output is automatically controlled to maintain full stroke volume as preload varies. Hall effect sensors for detecting rotary position of the motor are the only sensors used. Six bovine implants were performed, with durations of 84, 208, 244, 130, 70 (ongoing), and 15 (ongoing) days. Four animals used two-way telemetry, whereas the remaining two used one-way (outgoing) telemetry. These first chronic in vivo tests with the Penn State completely implanted LVAD system have demonstrated that it is a feasible solution to long-term ventricular support.

Brachymetatarsia. Axial lengthening by using the callus distraction technique.

The authors present a modified approach to the ilizarov callus distraction technique for bone lengthening on a patient with brachymetatarsia. This approach has certain advantages and disadvantages that will be discussed along with historical methods of treating brachymetatarsia. The actual case history, surgical technique, and perioperative care of the patient are described in detail.

Aortic pressure estimation with electro-mechanical circulatory assist devices.

An adaptive technique for the estimation of the time history of aortic pressure (from applied voltage and position feedback) has been designed, implemented, and bench tested using the Penn State Electric Ventricular Assist Device (EVAD). This method, known in the field of automatic control as a dynamic observer, utilizes gains which were determined using experimental data collected while the EVAD was running on a mock circulatory system. An adaptive scheme provides the observer with a method of changing its initial conditions on a stroke-by-stroke basis which improves observer performance. In both determining the feedback gains and developing the adaptation scheme, a range of beat rates and pressure loads was taken into account to yield satisfactory observer performance over a range of operating conditions. The observer was implemented, its performance was verified in vitro and results are reported. In the six experimental operating conditions, the beat rate ranged from 56-104 beats per minute (bpm) and the span of the mean systolic aortic pressure was 10.7-18.7 kPa (80-140 mmHg). For these cases, the mean deviation between the actual and estimated aortic pressure during the latter two-thirds of systole was 0.41 kPa (3.1 mmHg).

A long-term ventricular assist system.

An implantable, electrically powered pump that will provide tether-free circulatory support is being developed. The blood pump consists of a seamless polyurethane sac within a polysulfone case. Björk-Shiley Monostrut valves provide unidirectional flow. The blood sac is compressed by a pusher plate with a stroke of 1.9 cm and actuated by a brushless direct-current electric motor and motion translator. The current unit is completely sealed, and inductive coupling techniques provide the electrical energy. The system has an implantable electronic control system as well as a battery that provides 30 minutes of operation when the external coil is disconnected. During normal operation, however, the pump is powered by a portable battery pack or by house current. The unit can pump 8.5 L/min at physiologic pressures. Twenty-six animals have had circulatory support for a period of more than 1 week. The average period of pumping was 62 days; the longest was nearly 8 months. Experiments were terminated in 18 animals because of pump-related problems and in 8 because of biologically related problems. Studies to date are very encouraging and suggest that, with further refinement, a reliable 2-year assist pump that will have important clinical application can be developed.