[Tracheostomy valve with integrated cough flap for improving hands-free speech in laryngectomized patients--development and clinical applications]. / Tracheostomaventil mit integrierter Hustenklappe zur Verbesserung der fingerfreien Sprache des Laryngektomierten--Entwicklung und klinischer Einsatz.

BACKGROUND: Following successful voice restoration after laryngectomy either by a voice prosthesis, a surgical shunt or microvascular laryngoplasty, a further goal in rehabilitation is the insertion of a tracheostoma valve, which enables the patient to speak without using his fingers for closure of the tracheostoma. One important disadvantage of the tracheostoma valves, which are available today, is the necessity of removal of the valve in case of coughing, because the valve could be thrown from the stoma by the strong air flow during coughing. As many laryngectomies suffer from chronic bronchitis, this coughing problem is one of the reasons why only few patients could be provided with this useful aid. METHOD: At the department of biomedical engineering of the faculty of medicine at the university of Groningen, the Netherlands, 1994 two prototypes of a tracheostoma valve with an integrated cough lid were developed. These devices contain two separate valve systems: the normal speaking valve and a special coughing valve, which opens at a certain air flow and closes automatically after the coughing attack. Thus no manipulations are necessary during coughing, the patient can speak undisturbed. The ADEVA company (Lübeck, Germany) undertook the industrial production of this new type of tracheostoma valve creating different modifications of the prototype #2. PATIENTS: In four series with 6-8 patients per group the modified tracheostoma valves were tested clinically and the occurring faults or lack of correct function eliminated by small changes in the production. RESULTS: Meanwhile a suitable model for routine use is available, which was tested in 30 patients so far. This suitability was achieved by improvements in the valve mechanism, the valve seal and the adjustment mechanisms for the individual pressure level of the speaking and the coughing valve. CONCLUSION: The newly developed tracheostoma valve with integrated coughing lid (Window, ADEVA-medical Company, Lübeck, Germany) provides further improvement in speech rehabilitation of laryngectomies. The low acceptance of tracheostoma valves, which enable the patient to speak without using his fingers for closure of the tracheostoma, possibly may be raised by this new aid.

Airflow resistance of airflow-regulating devices described by independent coefficients.

Rehabilitation after laryngectomy includes more and more the use of airflow-regulating devices such as shunt valves (SVs), tracheostoma valves (TSVs), and heat and moisture exchange (HME) filters. In determining the quality of those devices, airflow resistance is a very important factor. It is currently defined as pressure drop divided by airflow. However, for most applications, this definition does not result in a pressure- and airflow-independent parameter. Therefore, a new set of parameters is defined and applied to pressure-airflow curves of airflow-regulating devices. Pressure drop over TSVs and HME filters appears to have a squared relationship with flow. In SVs, it has a linear relationship. The new set of parameters describes the pressure-airflow relationship properly for all considered devices. In conclusion, theoretical predictions of flow mechanics appear to be valid for SVs, TSVs, and HME filters. Only 2 coefficients are necessary to describe the pressure-flow characteristics of these airflow-regulating devices, independent of pressure drop over and flow through the device.

A novel tracheal tissue connector for fixation of laryngeal prostheses.

A tissue connector (TC), basically consisting of a ring that will be integrated into the trachea, is under development to study the fixation of laryngeal prostheses. Two experiments have been performed to test the TC in goats. In experiment 1, a polypropylene mesh was implanted around the trachea. The meshes were explanted after 6 and 12 weeks. In experiment 2, the actual TC consisted of two titanium rings (inner ring and outer ring) executed as quarter rings, fixed on each other, and a polypropylene mesh like a sandwich in between. The titanium inner ring was implanted between two tracheal rings thus penetrating the trachea with the mesh around the trachea and the fixed titanium outer ring on the outside of the trachea. The TCs were removed after 12 weeks. Experiment 1 showed that the mesh was entirely infiltrated by host tissue. Inflammatory cells and high vascularisation were observed in 3 of 4 implants. However, in experiment 2, the mesh was completely incorporated by mature connective tissue without inflammation reaction. At some areas, deposition of cartilage tissue was observed. In conclusion, the TC was firmly embedded in the trachea thus being appropriate for its intended use.

Numerical simulation of the influence of a left ventricular assist device on the cardiovascular system.

The PUCA (pulsatile catheter) pump is a left ventricular assist device (LVAD) capable of unloading the left ventricle (LV) and improving coronary flow by providing a counterpulsation effect. It consists of an extracorporeal located membrane pump, coupled to a transarterial catheter that enters the body via a superficial artery and ends in the LV. Blood is aspirated from the LV and pumped in the ascending aorta through the same catheter guided by a valve system. Timing and frequency of the PUCA pump influence its efficacy. To study the influence of several pump parameters a numerical model of the device and the circulatory system has been developed. Results of animal experiments were used to validate the model. Optimization studies resulted in a pump configuration with a stroke volume of 50 cc and pump:heart frequency mode of 1:2 that starts ejection at the beginning of diastole.

Numerical simulation of the pulsating catheter pump: A left ventricular assist device.

The pulsating catheter (PUCA) pump, a left ventricular assist device, consists of a hydraulically or pneumatically driven membrane pump, extracorporeally placed and mounted to a valved catheter. The catheter is introduced into an easily accessible artery and positioned with its distal tip in the left ventricle. Blood is aspirated from the left ventricle during systole and ejected into the ascending aorta during diastole. A numerical model of the PUCA pump has been developed to determine the internal diameter of the PUCA pump catheter that allows a certain blood flow. The model considers a limitation of mechanical blood damage and determines the accompanying pressure and flow profile for driving the pump. For a flow of 5 L/min, a catheter with an internal diameter of at least 6. 95 mm is required. For 3 L/min, the minimal diameter is 5.50 mm. The latter catheter can be introduced in the axillary artery, the former via the aorta during an open thorax surgical procedure. To validate the numerical model, 2 different PUCA pump configurations were tested in vitro. Results showed a good resemblance between model and in vitro behavior of the PUCA pump.

Biocompatibility of a novel tissue connector for fixation of tracheostoma valves and shunt valves.

Rehabilitation after laryngectomy often includes the use of a shunt valve and a tracheostoma valve to restore voice. To improve the fixation method of these valves, a new tissue connector has been developed, basically consisting of a ring that will be integrated into surrounding tracheal soft tissue. The valves can be placed in the ring. To test the principle of the tissue connector, a prototype consisting of a subcutaneous polypropylene mesh and a percutaneous titanium stylus was implanted into the backskin of 10 rats by a two-stage surgical procedure. We reasoned that if a firm connection can be realized with the skin, a firm connection with the trachea will also be possible. The subcutaneous part was implanted first, followed by the percutaneous part after 6 weeks. The complete tissue connector with surrounding tissue was removed 8 weeks later and examined histologically. The principle of the new tissue connector proved to be effective: hardly any epithelial downgrowth appeared, and adhesion of soft tissue was demonstrated. No infection or severe inflammation reaction was detected. The tissue connector seems appropriate for its intended use.

Design and test of a new tracheostoma valve based on inhalation.

BACKGROUND: Tracheostoma valves are used to make hand-free speaking possible for persons who have undergone a laryngectomy. OBJECTIVE: To design and test a new tracheostoma valve to improve existing tracheostoma valves. METHODS: The tracheostoma valve closes by means of strong inhalation so that all the air that is exhaled is available for phonation. The device automatically stays in the"speaking position" until the patient deliberately changes the device to the "breathing position" by a fast expiration. If all the air that has been exhaled has been consumed during phonation, the patient can inhale again, without changing the device, because a small valve automatically opens, thus allowing phonation without time limits. An experimental setup with a computer-based acquisition program was used to measure the pressure at which the valve opened and the flow at which the valve closed. The pressure and flow needed to open and close the magnetic adjustable valve were measured for different positions and contained in the computer through a data acquisition program. Also, the airflow resistance coefficients for inhaling and exhaling were measured. RESULTS: The airflow necessary to close the tracheostoma valve ranges from 1.6 to 3.8 L/s. The opening pressure of the valve ranges from 1 to 7 kPa. The airflow resistance coefficient is 290 Pa x s2 x L(-2) for inhalation and 430 Pa x s(2) x L(-2) for exhalation. CONCLUSIONS: The device appears to function well in physiological ranges and is optimally adjustable. The airflow resistance coefficient lies in the range of the entire airway resistance (120-470 Pa x s(2) x L(-2)) in quiet breathing.

In vitro measurements of aerodynamic characteristics of an improved tracheostoma valve for laryngectomees.

Tracheostoma valves are often required in the rehabilitation process of speech after total laryngectomy. Patients are thus able to speak without using their hands to close the tracheostoma. The improved Groningen tracheostoma valve consists of a "cough" valve with an integrated ("speech") valve, which closes for phonation. The cough valve opens as the result of pressure produced by the lungs during a cough. The speech valve closes by the airflow produced by the lungs, thus directing air from the lungs into the esophagus at a deliberately chosen moment. An experimental setup with a computer-based acquisition program was developed to measure the pressure at which the cough valve opened and the flow at which the speech valve closed. In addition, the airflow resistance coefficient of the tracheostoma valve was defined and measured with an open speech valve. Both dry air from a cylinder and humid expired air were used. Results showed a pressure range of 1-7 kPa to open the cough valve and a flow range of 1.2-2.7 l/s to close the speech valve. These values were readily attained during speech, while the flow range occurred above values reached in quiet breathing. The device appeared to function well in physiological ranges and was optimally adjustable to an individual setting. No significant differences were measured between air from a cylinder and humid expired air. Findings showed that methods used to obtain results could be employed as a reference method for comparing aerodynamic characteristics of tracheostoma valves.

Development of a numerical simulation model of the cardiovascular system.

A numerical simulation model of the cardiovascular system has been developed. It consists of a model of the left atrium, the left ventricle, the coronary vascular system, the aorta, the arterial system, and the venous system. The input of the complete model is the elastance (pressure/volume ratio) developed by the left ventricle. The shape of this elastance is constant in different circumstances. Left ventricular (LV) myocardial oxygen consumption and the amount of oxygen offered to the left ventricle can be calculated with the model. The model has been validated using data from a patient suffering from coronary artery disease. The measured clinical hemodynamical waveforms could be fitted to those generated by the model. With the numerical simulation model, it is possible to predict the functioning of the left ventricle under different circumstances. This makes it possible to study in vitro various pathological clinical situations.