About the Shikani Speaking Valve™

Design Specifications

The Shikani Speaking Valve™ leverages a patented ball-based mechanism as opposed to a flapper mechanism. As shown in our clinical presentations, the ball moves inside a chamber, where ramps act as a stop mechanism and also act as a guide that directs the ball towards the front or the back of the chamber.

The patient can vary the position of the valve (valve “up” or valve “down”) by rotating it 180°, which allows the ball to be seated in the proximal part of the chamber either in the “biased open” or “biased closed” position. With time, patients also learn intuitively how to control the movement of the ball inside the chamber of the valve by changing the angle of their body, from +20 degrees above the horizontal (which is a bias-open position), to zero degree, to -15 degrees from the horizontal (which is a bias-closed position). The patients hence learn instinctively, almost like riding a Segway, how to move the ball inside the chamber by moving their body, optimizing when to speak and when to breathe.

Thus, the SSV gives the patient flexibility and full control over the use of the valve to preferentially allow the exhaled air to escape through the proximal opening or redirect the air towards the larynx and speak.

Example candidates for the “biased open” position.

The biased open position allows for easier first-time introduction of the speaking valve to the tracheotomy patient. This position is excellent for pediatric patients or elderly patients with borderline pulmonary capacity. Patients with unique anatomy (e.g. stenosis, partial airway obstruction) that cannot tolerate every breath going through the upper airway, patients with severely compromised respiratory function, and patients that are anxious about using a speaking valve are also great candidates for the biased open position.

Example candidates for the “biased closed” position.

Patients who can tolerate every breath going through the upper airway, patients who are weaning from their tracheostomy tube, patients who are receiving nutrition by mouth, and patients who wish to speak for extended periods of time are good candidates for the biased closed position.

Advantages

The unique design of the Shikani Speaking Valve™ offers the tracheotomy patients many advantages and benefits, which significantly improve their overall quality of life. In addition to restoring speech, benefits include:

Significantly lower airflow resistance, resulting in increased comfort and ease of breathing.

An in vitro laboratory study has shown that the Shikani Speaking Valve™ is associated with a significantly lower airflow resistance as compared to the flapper speaking valves, which translates clinically into increased comfort and better tolerance by the tracheotomy patient.

Superior speech.

An IRB-approved clinical study has demonstrated that measures of patient voice quality and speech naturalness following use of the Shikani Speaking Valve™ are statistically significantly superior as compared to the Passy-Muir and Shiley speaking valves (statistical significance of p<0.001). General speech parameters, including maximum phonation S:Z ratio, jitter, noise, and turbulence were also found to be better following use of the Shikani Speaking Valve™.

Superior olfaction.

Hyposmia (loss of smell) is a well-recognized phenomenon in patients who have had their nasal airflow diverted through a tracheotomy. Speaking valves can help restore the sense of smell by redirecting airflow to the nasal cavity, which improves the patient’s olfactory detection thresholds. An IRB-approved clinical study confirmed that the Shikani Speaking Valve™ resulted in a statistically significantly superior improvement in olfaction and restoration of the loss of smell as compared to the Passy-Muir and Shiley speaking valves (statistical significance of p<0.001).

Eighty percent of the patients in this study subjectively preferred the Shikani Speaking Valve™ to the Passy-Muir and Shiley speaking valves, with the low visual profile and the ease of breathing cited as the two primary reasons for preference.

More effective cough.

Because the valve remains closed, except during active inhalation, all cough efforts are directed through the larynx and oral cavity, replicating normal physiology. The positive closure feature ensures that little air is lost through the tracheostomy tube, providing the patient with a more effective cough.

Improved swallowing.

In individuals without a tracheostomy tube, the vocal cords physiologically close during swallowing in order to prevent air from leaving the lungs during the swallow. The subglottic pressure is important for driving a strong swallow. Patients who have undergone a tracheotomy often have difficulty swallowing and may suffer from aspiration, due to the fact that the tracheostomy tube allows air to escape and as a result the patient is unable to generate enough subglottic pressure. The positive closure feature allows for subglottic pressure to be maintained and helps improve the swallowing process.

No honking noise.

Patients who use traditional flapper valves for more than a few weeks notice gradual deterioration of the quality of their voice due to honking associated with the aging flapper membrane. No honking occurs with the Shikani Speaking Valve™ as the ball does not deteriorate over time.

Discreet, low-profile design (smaller than flapper valves).

The frontal diameter of the Shikani Speaking Valve™ is 15mm, which is 25% smaller than the diameter of the Passy Muir flapper valve (20 mm). All flapper valve membranes have to be made a certain size in order to maintain their flexibility and fold. The ball valve does not have this limitation.

Ability to be used in unison with an HME.

A unique feature of the Shikani Speaking Valve™ is the fact that it can be used in unison with the Shikani HME™, allowing effective speech and humidification, warming, and filtration of air at the same time, a true paradigm shift in the care of the tracheotomy patient. In contrast, flapper speaking valves cannot be coupled with HMEs as their membranes close 100% upon exhalation, and therefore exhaled air cannot bypass the flapper valve and reach the HME. The Shikani HME™ can be used with the Shikani Speaking Valve™ during the day in order to achieve both improved speech and pulmonary health; afterwards, the same HME can be placed directly onto any standard 15mm tracheostomy tube cannula at night. Patients can therefore realize the benefits of the Shikani HME™ for a full 24 hours before replacing it with a new one the next day. More information on the benefits of the Shikani HME™ is included below.

Additional Features

• The valve is available in two colors, clear (less visible and typically used at-home) and blue (more visible and typically used in the hospital setting).

• Included with each Shikani Speaking Valve™ is a flexible retaining lanyard for attaching the valve to the tracheostomy tube to prevent loss of the valve.

• The Shikani Speaking Valve™ fits all standard 15 mm tracheotomy tube inner cannulas.

• The valve is proudly made in the USA and has received FDA clearance for compliance, patient safety and marketing.

About the Shikani Heat Moisture Exchanger™ (HME)

Design Specifications

The Shikani HME™ is designed for optimal airflow and enhanced moisture/humidity retention.

Air Turbulence

The Shikani HME™ has a unique outer shell with a dome at the top which provides additional volume above the media, which in turn enhances condensation and humidification within the body of the HME. A dimple in the center of the dome allows air to recirculate within the HME into turbulent Eddies currents, which are circular currents of air of many different length scales, similar to the ones that occur naturally in the lungs. The air is then redirected to the outside through large openings on the side of the HME upon exhalation. The reverse airflow occurs during inhalation. With each breath, recirculation of air creates air turbulence, and air particles face substantially higher transverse motion, friction, and pressure drag. Turbulent airflow thus creates more energy and achieves greater efficiency as compared to the traditional linear air flow HMEs.

Polyurethane Foam Inside the HME

The Shikani HME™ has a highly efficient hygroscopic media made of porous reticulated ester-type polyurethane foam that is impregnated with calcium chloride, which traps moisture and heat, and provides a very effective filter from unwanted particles.

The increase in efficiency associated with the Shikani HME™ allows the device to be lighter, more compact, and more discreet relative to the existing traditional HMEs on the market. The Shikani HME™ turbulent airflow design has been shown to have significantly lower airflow resistance relative to the traditional linear airflow HME design. It is important to note that whether placed directly onto the inner cannula of the tracheostomy tube or used in conjunction with the Shikani Speaking Valve™, the Shikani HME™ does not add significant airway resistance. Importantly, the Shikani HME™’s design results in enhanced moisture/humidity retention within the body of the HME, while allowing for a smaller size profile relative to other HMEs on the market.

Complications Associated with Tracheotomy and Benefits from HME Use

Patients who undergo a tracheotomy lose essential airway functions including speaking, smelling, tasting, swallowing, and humidification, warming and filtering of inhaled air. While speaking valves can help offset some of these losses (i.e. speaking, smelling and swallowing), they do not help restore three critical functions that are lost when air is diverted away from the nose, the natural organ of the body responsible for:

1. Humidification of inhaled air

2. Warming of inhaled air

3. Filtration of unwanted particles (dust, bacteria, viruses, environmental irritants, and airborne pollutants)

Inhaling cold, dry and unfiltered air through a tracheotomy tube can have a severely negative impact on pulmonary health. Patients who breathe directly through the tracheostoma opening lose approximately 500 ml of water daily. Over time, mucus thickens, mucociliary transport and function deteriorates (as cilia get bogged down in the mucus), and mucosal dehydration occurs. This is often followed by desquamation of epithelial cells and ulceration. As mucus secretion worsens, gobs of dried mucus form and drop into the deeper bronchi, occluding the alveoli and causing atelectasis (collapse of the alveoli of the lungs). See these bronchoscopy videos of tracheotomy patients who do not use HMEs regularly. This pathophysiology often starts within a few days of a tracheotomy but worsens over time and can cause chronic cough and occasionally life-threatening pulmonary infections in patients who live with a tracheotomy for a long period of time. Patients who breathe directly through a tracheostoma opening constantly (such as laryngectomy and permanent tracheotomy patients) have been shown, by bronchoscopy biopsies, to develop basal cell hyperplasia, squamous metaplasia, and even dysplasia of the tracheal mucosa. These conditions can be prevented with the regular use of an HME.

Advantages of the Shikani HME

Invented by Alan Shikani, MD, FACS, the Shikani HME™ is the first true innovation in the field of tracheotomy heat and moisture exchangers. The Shikani HME™ functions as an artificial nose and is designed to restore some of the essential respiratory functions which are lost when the breathed air is directed away from the nose. In particular, the Shikani HME™ filters airborne environmental particles from air inhaled by the tracheotomy patient; it retains moisture and heat from air that is exhaled out of the lungs; and upon re-inhalation, it filters, humidifies, and warms air returned to the lungs. Studies have shown that the use of an HME for a period as short as 10 minutes significantly decreases respiratory humidity evaporation and heat loss; patients using an HME can retain 250-300 ml of the 500 ml of water lost daily as a result of breathing through the tracheostoma. By using an HME consistently, tracheotomy patients can achieve:

• More normalized and uniform temperature levels from inhaled air.

• More normalized and uniform humidity levels from inhaled air.

• Substantially increased particle filtration from inhaled air.

• Reduced mucus secretion and thickening.

• Reduced risk of pulmonary infection, a costly procedure to both patients and hospitals.

• Restored pulmonary conditions and health.

An additional advantage of the Shikani HME™ with Oxygen Port is that its connecting tube (i.e. the tube that connects the HME with the oxygen supply tank) is a small, light, and soft catheter, which is considerably lighter and more comfortable than many of the existing delivery hoses that are used with traditional oxygen-HMEs currently on the market. See instructional video on how to attach the catheter to the Shikani HME™ and oxygen tank.

For additional comfort, a small clip is included with the catheter to allow it to be secured to the patient’s shirt.

Ability to be Used in Unison with a Speaking Valve

A unique feature of the Shikani HME™ is the fact that it can be used in unison with a speaking valve. The Shikani HME™ is the only HME on the market that when coupled with a speaking valve, allows effective speech and humidification, warming, and filtration of air at the same time, a true paradigm shift in the care of the tracheotomy patient. The Shikani HME™ can also be placed directly onto any standard 15mm tracheostomy tube cannula.

Prior to the Shikani Speaking Valve™ design, patients had to choose either to wear a speaking valve for communication and forgo the benefits of an HME, or alternatively to wear an HME and forgo the benefits of a speaking valve. The traditional flapper-type speaking valves that are currently on the market have a membrane that opens to allow air to flow through the cannula and into the lungs during inspiration and closes upon exhalation. The closing of the membrane prevents air from flowing through the cannula, therefore making it impossible for exhaled air to reach the HME. By design, these traditional flapper-type speaking valves cannot be used concurrently with HMEs.

Superiority of the turbulent airflow Shikani Oxygen HME™ over the traditional linear airflow HME

Tracheostomy HME use is associated with improved indicators of tracheobronchial mucosal health, humidity, and oxygenation. In a randomized cross-over study (Linear versus Turbulent Airflow Tracheostomy Heat and Moisture Exchangers), the turbulent airflow Shikani Oxygen HME™ outperformed the linear airflow Mallinckrodt Tracheolife II HME with respect to tracheobronchial inflammation, oxygen saturation, and patient preference. Using an HME 24 hours a day is recommended for tracheostomy patients in order to optimize pulmonary health. Traditional flapper-type speaking valves are not compatible with HMEs; however, the Shikani ball-type speaking valve allows tracheotomy patients the opportunity to wear an HME and a speaking valve concurrently, allowing the benefit of humidification and oxygenation while preserving speech.