Establishing a novel and effective alternative to CPAP is no easy task, but the inventor of oral pressure therapy (OPT) believes he has the technology to do just that.

Matt Vaska is not your average garage tinkerer. As a Stanford-educated mechanical engineer with an affinity for medical solutions, the founder of ApniCure does not hesitate to focus his problem-solving skills on a host of vexing problems.

When his own dad could not cope with CPAP a few years ago, the 20-year medical technology veteran went looking for alternatives. “I was trying to figure out if there were other therapies,” says Vaska, who founded and sold a cardiac-related company prior to starting ApniCure. “The more I learned, the more I realized this was a huge opportunity.”

While acknowledging the clinical effectiveness of CPAP, Vaska believes the industry’s “gold standard” leaves a lot to be desired. He ultimately attacked the problem from a mechanical perspective. “The tongue and soft palate are the bad actors,” he says. “There must be a better way to move those things than putting a mask on your face every night. I started experimenting in my garage with a bunch of random ideas.”

From those humble beginnings, Vaska developed The Winx™ Sleep Therapy System, which uses a proprietary platform technology called oral pressure therapy (OPT) to treat obstructive sleep apnea (OSA). The system is designed to offer a comfortable sleeping experience, allowing users to breathe naturally without a mask.

OPT is a light, oral vacuum delivered by a quiet console through a slim tube connected to a soft, flexible mouthpiece. The mouthpiece and vacuum work together to gently pull the soft palate forward and stabilize the tongue, increasing the size of the airway to allow for natural breathing during sleep.

Why Didn’t I Think of That?

At this year’s SLEEP show in Boston, curious physicians took a close look at the device, which is essentially a mouthpiece that fits completely inside the mouth. “It has a little bar that goes across the back that keeps your tongue from rising all the way to the roof of your mouth,” explains Vaska. “That creates a little pocket between your tongue and the roof of your mouth in the back. You apply a light vacuum to that pocket—and the soft palate will move easily, almost like a sail—and pull itself up against the tongue.

“We also take advantage of a natural seal that occurs between the soft palate and the tongue so the negative pressure does not end up in the airway,” he continues. “If that happened, it could exacerbate the disease. We keep all the negative pressure in the oral cavity. There is a little shield on the front of the device to keep air from coming in the front of the mouth, so you have a completely sealed oral cavity with this device in place.”

With need as the mother of invention, Vaska’s idea to use negative pressure in the oral cavity proved to be the crucial lynch pin. “You don’t need a mask because you breathe naturally through your nose,” adds Vaska who has also developed medical devices in for cardiac surgery, electrophysiology, laparoscopy, and arthroscopy. “It’s actually somewhat similar to CPAP in that there is a higher pressure in the airway and a lower pressure in the oral cavity—but we do it by lowering the pressure in the oral cavity instead of increasing the pressure in the airway.”

There is currently no other FDA-approved technology available to treat sleep apnea that uses an oral vacuum, so Vaska contends that the Winx is truly something new under the sun. Along with the mouthpiece, there is a pressure generator and a tubing set. Compliance monitoring is also available via an SD card and accompanying software.

Taken as a whole, docs at SLEEP came away intrigued, and even a bit envious. “When you explain pressure differential and how you can do it differently, a lot of physicians will say, ‘Why didn’t I think of that?’” says Vaska with a smile. “Once you see it, it makes a lot of sense, and that is gratifying for me. It uses something familiar, but avoids the problems of the mask.”

Vaska contends that the Winx’s effectiveness translates to severe apnea, in addition to mild and moderate. From a compliance standpoint, ApniCure tests show 6 hours on average per night and 90% nightly usage.

All About Options

Oral appliances have made major inroads in recent years, but ApniCure officials believe their option may be more attractive—and less expensive. “Unlike with an oral appliance, where you must go to a dentist and spend months and thousands of dollars up front for fitting, we figured out how to do it in five minutes,” says Vaska. “For the sleep physician, it is straight forward to provide the product, and we expect it is going to be a lot less of a hassle factor when dealing with patients.”

Adding another viable treatment option to the medical world is a huge task, and ApniCure officials are not rushing the process. After securing FDA approval and increasing awareness at trade shows, the road to acceptance is still long.

Vaska has been there before with other ventures, so he has the patience for the long haul. Part of that patience stems from confidence, and a belief in the product and the market.

With massive demand, Vaska’s colleague Steve Carlson, president and CEO of Redwood City, Calif-based ApniCure, agrees that there is enough room for many options. “It is our goal to do it right with a careful, methodical, and controlled launch as we interface with managed care, other payors, and sales distribution,” says Carlson. “In 2013, we plan to do a full United States launch.”

Benefits of the Winx system include: soft, flexible mouthpiece allows breathing naturally through the nose without a mask or forced air; slim tubing that allows sleeping in any position; a quiet console that creates a peaceful sleeping environment for users and bed partners; discreet design that allows users to appear and feel natural while they sleep; a small, portable, and travel friendly design; design that is simple to use, clean and maintain; and easy setup for patients to trial.

Evidence Builds

Data presented as late-breaking abstracts at the 2012 American Thoracic Society (ATS) Conference helped build the case for oral pressure therapy (OPT).

In May 2012, ApniCure Inc, Redwood City, Calif, presented positive results from trials of the Winx™ Sleep Therapy System in patients with obstructive sleep apnea (OSA). Study results demonstrated significant improvements in apnea-hypopnea index (AHI); oxygen desaturation index (ODI); sleep architecture; and symptomatic measures of OSA; as well as high patient satisfaction with Winx.

These clinical data, as well as mechanism of action data, were presented as late-breaking abstracts during the “Diagnostic and Therapeutic Approaches in Sleep Apnea” session at the 2012 American Thoracic Society (ATS)

Conference in San Francisco.

“In the ATLAST trial, Winx significantly improved the severity and symptoms of OSA, was shown to be safe and was associated with high nightly usage and patient satisfaction,” said Richard K. Bogan, MD, chairman and chief medical officer of SleepMed Inc, and associate clinical professor of the University of South Carolina School of Medicine. “These are important findings because continuous positive airway pressure (CPAP), the standard treatment for OSA, can be associated with physical and lifestyle challenges related to its forced air delivery through

a mask. Winx, which allows users to breathe naturally without a mask, represents a new, non-invasive alternative for some patients with OSA, a serious disease that is associated with long-term medical and social consequences.”

ATLAST Trial Design and Results

The multi-center, prospective ATLAST study examined the safety, effectiveness, and tolerability of the Winx system in 60 patients ages 32 to 80 with mild, moderate or severe OSA, with or without prior CPAP use.

Study participants underwent laboratory polysomnography at baseline with and without Winx treatment, and again following 28 nights of treatment with Winx to determine ODI and AHI, which was calculated using American Academy of Sleep Medicine criteria by a blinded scorer.

OSA symptoms were assessed with the Epworth Sleepiness Scale (ESS) and a modified Functional Outcomes of Sleep Questionnaire (mFOSQ). Nightly usage of Winx was assessed objectively by the system console which collected data on a standard data card.

The ATLAST study showed a significant reduction in AHI and ODI and was safe and durable. A substantial proportion of patients met the prospectively defined clinical success criteria, and these patients were easy to identify and included mild, moderate and severe OSA. Patients had significant improvement in sleep architecture and quality of life measures.

Patients showed high nightly compliance and preference over alternative therapies. Winx treatment was also shown to be compatible with current clinical practice due to features such as in-lab mouthpiece fitting, objective compliance monitoring, and compatibility with polysomnography systems.

Allen J. Moses D.D.S., Richard A. Bonato Ph.D. and Gloria L. Pacini R.D.H.

Abstract

The long axes of human condyles are angulated medially and slightly backward. A line through one condylar pole and projected to the midline will meet the line from the other side at approximately the anterior border of foramen magnum. The lateral and medial poles of the mandibular condyles are not in a linear plane. Mandibular movement based on translatory movement of the condyle against the disc and that of the disc in independent translatory movement against the glenoid fossa describes diarthrodial movement.

In human beings, unique in the animal kingdom for their upright bipodal posture, the most important function of the back and neck is to balance the head on the spinal column. Because of the dual function of the oropharynx as foodway and airway, it is essential that human beings be able to breathe during mastication. Adult humans lack the ability of most mammals to breathe and swallow at the same time. The mechanical advantage of the diarthrodial anterior translatory movement of the TMJs is to keep the airway patent during mastication.

Internal software in a 3D cone beam tomographic unit calculated each condylar angle relative to where each intracondylar line intersected a line perpendicular to the defined midline. Sleep group mean intracondylar angle was 5.4 degrees; intracondylar angle in the control group was 5.18 degrees. There was no statistically significant difference in overall intracondylar angle between the sleep group and non- sleep group. Intracondylar asymmetry is shown in this study to be the normal state in human beings and this being the case, translatory jaw movement would almost never occur in a straight midline linear plane.

Some devices which restrict mandibular protrusion to a midline linear plane to register the maxillomandibular relationship for an intraoral sleep appliance do not take into account the predominance of intercondylar asymmetry in humans. Their use would be biomechanically contraindicated. Polypropylene bite shims are shown that can be aligned so the mandible can freely slide in a protrusive path guided by muscle, ligaments, nerves and bony physical irregularities, rather than by an artificially imposed midline linear plane.

—————————————

Richard Bonato, Ph.D. is CEO and C-founder of BRAEBON Medical Corporation which sells medical devices for snoring and sleep apnea to sleep laboratories and dentists worldwide. He has no financial interest in bite shims or any bite registration products.
Allen J. Moses, D.D.S. and Gloria L. Pacini, R.D.H. are co-inventors of the bite shims shown in figure 10. They have a financial interest in their sales.

TMJ Mechanics

Temporomandibular joint (TMJ) movement in humans has been a controversial subject for over half a century. The application of proven biological and mechanical as well as 3-D computerized graphic representations to anatomic function has resulted in significant progress relative to understanding temporomandibular joint function. For many years it was thought that the human TMJ was capable of hinge function.^1,2,3,4 The reference in the older dental literature to the human TMJs as a ginglymoarthrodial (hinge-sliding) joint is testimony to this popular misconception.^{5,6,7,8,9,10,11,12,13,14,15} The TMJs of many lower animals do indeed function as a pure hinge (see Figure 1). The TMJs of animals are bilateral, joined as a functional unit by the body of the mandible. The requisite condition for bilateral hinge function to occur is that the hinges must be in a linear plane. Door hinges are an example of multiple hinges functioning as a mechanical unit in a linear plane. There are many animals whose jaws are capable of pure hinge function and whose mandibular condyles are in the same linear plane. They do not assume an upright bipodal posture and they do not have a flexible, compliant airway.

The long axes of human condyles are angulated medially and slightly backward (see Figure 2). A line through one condylar pole and projected to the midline will meet the line from the other side at approximately the anterior border of foramen magnum.¹⁶ The lateral and medial poles of the mandibular condyles are clearly not in a linear plane. Therefore, pure hinge movement of the human mandibular condyles is not mechanically possible (see Figures 3A & 3B).

The mandibular condyle in humans is a convex bony surface from front to back that articulates with the temporomandibular disc. No articular surfaces are perfectly flat and the surface curvatures vary from point to point. The temporomandibular disc in turn articulates with the glenoid fossa of the temporal bone. Mandibular movement is based on translatory movement of the condyle against the disc and that of the disc in independent translatory movement against the glenoid fossa. “The articulation of each side of the jaw is a composite that encloses two joints within its single capsule, an upper joint between articular eminence and disc and a lower joint between disc and mandibular condyle. In essence then it can be said that the functional joint articulation is a double-double joint.”¹⁷ This more accurately describes diarthrodial movement rather than ginglymoarthrodial movement.

Biological Evidence for Pure Diarthrodial TMJ Movement

The human tongue is unique among mammals. In humans the anterior 2/3 of the tongue is oriented horizontally in the mouth with the posterior 1/3 being oriented vertically in the oropharynx, when the human is standing or sitting erect. In human beings, unique in the animal kingdom for their upright bipodal posture, the most important function of the back and neck is to balance the head on the spinal column.

The head however, has a mobile part, the mandible, that needs constant counterbalancing as it moves about in its normal functions of speech, mastication and swallowing. The human oropharynx serves the dual function of foodway as well as airway and humans are unique for the ability to articulate speech. The flexible airway from the soft palate to epiglottis was certainly a major evolutionary change that facilitated speech. Creation of a flexible airway and highly innervated tongue is the defining characteristic that enables vowel sound creation. The benefits of speech with a flexible airway/foodway also engender the downside risks of apnea, snoring and choking.

Because of the dual function of the oropharynx as foodway and airway, it is essential that human beings be able to breathe during mastication. Adult humans lack the ability of most mammals to breathe and swallow at the same time because of the flexible airway and the posterior 1/3 of the tongue being vertical. If rotational TMJ movement were possible, the resulting masticatory hinge motion would close the airway during mastication. The mechanical advantage of the diarthrodial anterior translatory movement of the TMJs is to keep the airway patent during mastication. The anatomic evidence for pure diarthrodial movement is indeed very convincing.

Collapse of the tongue and/or soft palate on the airway during sleep explains the etiology of obstructive sleep disordered breathing (SDB). Design of an oral appliance for treatment of SDB involves finding a position of maximal airway patency during sleep. In assessing the maxillo-mandibular position of maximal airway patency, clinicians must consider the mechanics of jaw, tongue and lip positions. The chief basics of appliance design:

1. Mandibular advancement
2. Oral airway dilation
3. Maximize room for the tongue in the mouth
4. Prevent collapse of the tongue and/or soft palate on the airway
5. Optimize nasal breathing¹⁸

The Bony Anatomy of Condylar Translation

The directions and limits of mandibular movements are controlled by muscles, ligaments and nerves, but also by biomechanical restraints in the temporomandibular joints.19 Biomechanical restraints can be in relation to shape or function. Asymmetry of condylar angles could be a limiting factor to pure midline translatory movement of the mandible.

Eisenberger,²⁰ Christiansen²¹ and Yale²² have measured the intercondylar angle (ICA). The mean intercondylar angle in these papers was 139°, 129° – 132°, and 153° respectively. Eisenberger demonstrated no significant difference in the intercondylar distance between the dysfunctional group, the control group and the children’s group. These papers only reported the one intercondylar angle. They did not study or factor in condylar asymmetries. From a purely mechanical perspective, symmetrical condyles should be able to translate in a straight midline trajectory. Conversely, it is not logical to assume that translatory movement by asymmetric condyles could protrude the mandible in a straight midline trajectory.

There are certain situations in clinical treatment of temporomandibular disorders involving disc displacement or SDB where it might be of significance to determine whether the condyles could or should be directed protrusively in a midpoint linear plane, or whether the anatomic evidence is stronger that movement is more appropriately guided in an eccentric plane. The hypothesis being tested is whether intercondylar symmetry or asymmetry is the normal condition. If intracondylar asymmetry is the normal condition, might the extent of the asymmetry contraindicate the use of devices designed to record the maxillo-mandibular relationship for an intraoral sleep appliance that limit protrusive movement to a midline cranial plane? This is germane to the bite registration techniques employed by dentists worldwide for the fabrication of custom therapeutic oral appliances for the treatment of SDB. Consistent with previous research by Eisenberger et al. (1999),²³ it was hypothesized that no statistically significant difference in intracondylar angles would be found between a group of sleep apnea patients and a control group.

Method

Subjects

The data being presented is based on a retrospective study from the dental records of one author (AJM). Axial tomograms of the 33 most recent consecutive TMD/Sleep referral patients were analyzed as described above and the 33 randomly chosen general dental patients were identically analyzed as a control group. Appropriate releases were signed by all patients.

Data from two groups of 33 patients were retrospectively analyzed. The first group was referred for treatment of sleep apnea and included 25 men (sleep group mean age for men = 45.5 years) and 8 women (sleep group mean age for women = 58.3 years). The range of age is 18-71. The second group is a control group of patients, 17 men (non-sleep group mean age for men = 34.3 years) and 16 women (non-sleep group mean age for women = 33.0 years), seen during routine dental visits and evaluations. The range of age is 19-59.

Materials/Equipment

A three dimensional cone beam tomography unit (Imaging Sciences i-CAT® Next Generation Cone Beam 3D Dental Imaging) was utilized. Axial radiographic slices were located that revealed the maxillary dental midline, the superior surface of both condyles and the foramen magnum. These tomographic views were oriented on the monitor screen so that the midline was defined as passing through the dental midline (between teeth numbers 8 and 9) and the center of foramen magnum (see Figure 4). Lines were identified and drawn through the mesial and distal poles and the center point of each condyle (MB). Internal software (Anatomage Invivo 5 Anatomy Imaging Software) in the cone beam unit then calculated each condylar angle relative to where each intracondylar line intersected a line perpendicular to the defined midline (see Figure 5).

Results

To test the hypothesis that there would be no difference in intracondylar angles between the two groups, the left condylar angle was subtracted from the right condylar angle and an independent sample t-test was performed on the absolute value of the intracondylar angle differences. The sleep group mean intracondylar angle was 5.4 degrees (sd = 3.93) whereas the mean intracondylar angle in the control group was 5.18 degrees (sd = 3.41). For the sleep group intracondylar angles ranged from 0.2 degrees to 15.9 degrees. The control group intracondylar angles ranged from 0.0 degrees to 15.1 degrees. The t-test revealed no statistically significant difference in overall intracondylar angle between the sleep group and non-sleep group, t(64) = 0.24, p = 0.81 (see Figure 6).

Additional independent sample t-tests did not reveal any statistically significant difference in right condylar angle differences between the sleep group (mean=24.71, sd = 8.54) and non-sleep group (mean = 28.47, sd = 7.27), t(64) = –1.92, p = 0.06, or in left condylar angle differences between the sleep group (mean = 25.48, sd = 8.65) and non-sleep group (mean = 27.97, sd =7.13), t(64) = –1.27, p = 0.20 (see Figures 7 & 8).

Discussion

There does not appear to be any statistical difference between the study group of TMD/Sleep Patients and the control group. Both groups demonstrated similar intercondylar asymmetry. In fact, condylar symmetry appears to be the exception rather than the expectation. The average intercondylar asymmetry of the two groups combined is 5.36 degrees. If one assumes that the mechanics of protrusion are the same in all humans, then the study subject with an intercondylar asymmetry of 15.9 degrees employs the same mechanics to achieve protrusive translation as the person with a symmetric condylar relationship. Since the mandible is a single bone, the joints of each side are coordinated so that each contributes to every movement. The craniomandibular connection is one operating unit composed of right and left joint complexes.

The translatory component of joint movement is completely dependent on the shape of the articular eminence, according to Sicher and DuBrul.24 It is predictable that asymmetry of intercondylar angles also relates to asymmetry of the articular eminences of the temporal bones. Condyles, discs and eminences are in close contact in all movements and in all positions. This means that all movements of condyles with their discs must follow exactly the surfaces of the articular eminentia.25 Intercondylar asymmetry is shown in this study to be the normal state in human beings and this being the case, translatory jaw movement would almost never occur in a straight midline linear plane.

On the basis of the measurements from this study it would seem logical to assume that devices which restrict mandibular protrusion to a midline linear plane (see Figure 9) do not take into account the predominance of intercondylar asymmetry in humans. By their limitation of protrusive translation to a midline linear plane their use would be biomechanically contraindicated.

There are alternatives to devices that record the maxillomandibular relationship by physically guiding protrusive movement to a midline cranial plane. Polypropylene bite shims are shown (see Figure 10) that can be aligned so the mandible can freely slide in a protrusive path guided by muscle, ligaments, nerves and bony physical irregularities, rather than by an artificially imposed midline linear plane. Elimination of the artifactual effect of mechanical devices that restrict anterior movement in registration of the maxillo-mandibular relationship would be biologically beneficial in treatment with oral sleep appliances.

Conclusion

Based on the predominant finding of intercondylar asymmetry, the mandibular midline will most likely deviate to one side or the other in protrusive translatory movement, rather than follow a straight midline linear plane. Devices that limit translatory movement to a midline linear plane may not have a sound scientific basis. An alternative device to register the maxillomandibular relationship for intraoral sleep appliances was discussed that does not restrict normal biologic movement.

A prospective clinical study whose design directly tests the actual trajectory of unrestricted translatory protrusive mandibular movement appears to be indicated.

A prospective clinical study that tests the clinical efficacy of the bite shims versus one of the devices shown that directs protrusive translatory movement in a midline linear plane also appears to be indicated.

References

1. Zola, A, Morphologic Limiting Factors in the Temporomandibular Joint, Journal of Prosthetic Dentistry, 1963, Volume 13, Number 4, p733
2. Brekke, CA, Jaw function: Part 1, Hinge Rotation, Journal of Prosthetic Dentistry, v 9: 1959.
3. Cohen, R, The Hinge Axis and its Practical Application in the Determination of Centric Relation, Journal of Prosthetic Dentistry, 1960.
4. Griffin, CJ, Hawthorn, R, Anatomy and Histology of the Human Temporomandibular Joint, Monographs in Oral Science, 1975, 4:1–26.
5. Kreutziger, KL, Surgery of the Temporomandibular Joint, Oral Surgery, Oral Medicine, Oral Pathology, Vol 58, Issue 6, Dec 1984, p 637–646.
6. Luyk, NH, The Diagnosis and Treatment of the Dislocated Mandible, American Journal of Emergency Medicine, May 1989, Vol 7, Issue 3, p 329–335.
7. Israel, HA, Current Concepts in the Surgical Management of Temporomandibular Joint Disorders, Journal of Oral and Maxillofacial Surgery, March 1994, Vol 52, Issue 3, p 289–294.
8. Potter, JK, Vascularized Options for Reconstruction of the Mandibular Condyle, Seminars in Plastic Surgery, 2008, 22(3), p 156-160.
9. Coplane, J, Diagnosis of Mandibular Joint Dysfunction, Oral Surgery, Oral Medicine, Oral Pathology, September 1960, Vol 13, Issue 9, p 1106–1129.
10. Quinn, PD, Alloplastic Reconstruction of the Temporomandibular Joint, Selected readings in Oral and Maxillofacial Surgery, 2002, Vol 7.5.
11. Bayles, TB, The Temporomandibular Joint in Rheumatoid Arthritis, Journal of the American Medical Association, 1941, 116(26), p 2842–2845.
12. Michaud, TC, The Influence of Two Different Types of Foot Orthoses on First Metatarsophalangeal Joint Kinematics During Gait in a Single Subject, Journal of Manipulative and Physiological Therapeutics, January 2006, Vol 29, Issue 1, p 60–65.
13. Alomar, X, Anatomy of the Temporomandibular Joint, Seminars in Ultrasound, CT and MRI, June 2007, Vol 28, p 170-183.
14. Chan, TC, Mandibular Reduction, Journal of Emergency Medicine, May, 2008, Vol 34, Issue 4, p 435–440.
15. Lowery, LE, The Wrist Pivot Method, A Novel Technique for Temporomandibular Joint Reduction, Journal of Emergency Medicine, August 2004, Vol 27, Issue 2, p 167-170.
16. Gray’s Anatomy, 27th Edition, Henry Gray FRS, 1959, Lea and Febiger, Philadelphia.
17. Sicher’s Oral Anatomy by DuBrul EL. CV Mosby Co, St Louis, 7th Ed. 1980, p 184
18. Fitzpatrick, MF, et al., Effect of Nasal or Oral Breathing Route on Upper Airway Resistance During Sleep, Eur Respir J 2003; 22:827–832
19. Osborn, JW, The disc of the human temporomandibular joint: design, function and failure. J Oral Rehabil. 1985, Jul 12(4):279-93
20. Eisenburger, M, The human mandibular intercondylar angle measured by computed tomography, Archives of Oral Biology, Vol 44, Issue 11, Nov 1999, p 947–951.
21. Christiansen, E., Intra- and inter-observer variability and accuracy in the determination of linear and angular measurements in computed tomography: An in vitro and in situ study of human mandibles, Acta Odontologica Scandinavica, 1986, Vol. 44, No. 4, pp 221–229.
22. Yale, S, Laminagraphic cephalometry in the analysis of mandibular condyle morphology, Oral Surgery, Oral Medicine, Oral Pathology 14, 1961, pp 793–805.
23. Eisenburger, M, The human mandibular intercondylar angle measured by computed tomography, Archives of Oral Biology, Vol 44, Issue 11, Nov 1999, p 947–951.
24. Sicher’s Oral Anatomy by DuBrul EL. CV Mosby Co, St Louis, 7th Ed. 1980, p.192
25. Sicher’s Oral Anatomy by DuBrul EL. CV Mosby Co, St Louis, 7th Ed. 1980, p.192

Heading into its 77th year in business, Grass Technologies continues to update and innovate.

Long before the widespread awareness of sleep disordered breathing among patients and physicians alike, engineers at Grass Technologies were quietly plying their trade. The result is a rich tradition that keeps company officials looking forward, while never losing sight of their roots.

Marc R. Paliotta, BSEE, clinical product manager at Grass Technologies (an Astro-Med Inc Subsidiary), joined the venerable company in 1997 during the transition from analog to digital. In those 15 years, manufacturers have seen nothing less than a revolution in sleep diagnostics.

Revolution can be a good thing, but it frequently brings uncertainty. Paliotta acknowledges the ever-changing nature of the business, using a dose of cautious optimism that has served him well. That realistic outlook can be seen in the company’s product offerings, with in-lab diagnostics and out-of-center technologies equally embraced. “We cultivate traditional in-lab diagnostics and home sleep testing Type I, II, and III technologies,” says Paliotta.

A tradition of cutting-edge technology has done nothing to dim Paliotta’s commitment to old-school customer interaction. The philosophy can be seen in Grass Technologies’ enthusiasm for industry trade shows such as the Associated Professional Sleep Societies (APSS) Conference. “You get the much valued face-toface time with your customers,” explains Paliotta. “Whether it’s a little local show, a mid-size regional show, or a large national or international trade show such as APSS. The APSS is typically our biggest trade show of the year.”

Paliotta views every APSS show as a chance to show the company’s complete line from a hardware standpoint, in addition to the software that runs the entire product line. “This year, we’ll be showing the Comet-PLUS, which is our in-lab sleep diagnostic device,” enthuses Paliotta. “The AURA PSG is our type I/II out- of-lab device. The SleepTrek3 is our type III HST device. Those are the three complete product offerings we’re showing. The common software is called TWin and runs the entire Grass line.”

Looking Back, Surging Forward

Since going digital in the mid 1990s, Grass has been known for its amplifier systems. Maintaining a consistently high level of performance and supportability is at the heart of that reputation.

“We take it very seriously,” says Paliotta. “We’ve been able to incorporate the latest technology in industry to help meet the needs of our customers in the field. From the hardware and software perspective, we feel as a company we’re able to incorporate the needs of our customers into our products in a relatively short cycle working with our customers directly. Home sleep testing, for example, is an area everyone is interested in and where we are dedicating a good amount of time and effort.”

Grass is dedicating additional efforts toward IT Solutions in response to sleep labs‘ increasing dependence on IT departments for functions such as remote review, SQL databasing, and EMR integration. Grass acts as the liaison between the sleep labs and the IT departments, which leads to smoother integration and better IT Solutions.

The commitment to direct customer interaction comes from the same innovative tradition established long ago by company founder Albert Grass. Grass developed the first commercially successful electroencephalograph (EEG), a key component of neurophysiology and ultimately polysomnography (PSG).

The following is a chronology of the beginnings of EEG/PSG technology, and consequently, of Grass Instrument Company.

1934: A small grant is awarded to Dr. Frederic Gibbs for instrumentation to process electroencephalographic data. His goal is to apply the knowledge gained by Hans Berger and confirmed by Lord Adrian to clinical applications.

1935: Dr. Gibbs approaches Albert Grass, a recent graduate of MIT, to design three devices to amplify human EEG potentials. Grass does so, defining the foundation of Grass Instrument Company, and of EEG technology.

1936: While working at Harvard Medical School, Grass designs moving coil galvanometers, which enables the embryonic EEG instrumentation to accurately and reliably record the EEG frequencies on chart paper. The addition of these new galvanometers to his early amplifiers becomes the Grass Model I, used by Gibbs, Lennox, Davis and others. This same amplifier design was used by Cannon, Rosenbluth and Renshaw in early neuromuscular studies.

APSS Offerings for Grass Technologies Inc, an Astro-Med Subsidiary

Comet-PLUS® XL Lab-based PSG – Recording & Review System

Comet-PLUS XL is a complete PSG system designed to satisfy the needs of the physician’s office, hospital, or medical center. Ready to use, Comet-PLUS XL is supplied with the latest high performance PC.

These diagnostic systems consist of the high response 57-channel AS40-PLUS Amplifier System, a quick-disconnect head- box with electrode inputs designed especially for PSG, TWin PSG Record and Review Software, and powerful Panorama digital video. These flexible systems upgrade easily to also record EEG-type studies.

SleepTrek3, a 6-channel Portable Monitor

This small, lightweight physiological data recorder is specifically designed to assist the clinician in the diagnosis of sleep- disordered breathing. The out of center sleep testing device uses sensors to record oxygen saturation, pulse rate, airflow, snoring, respiratory effort and body position. The screener is designed to be used in a supervised (hospital/institutional) or unsupervised (home) environment.

TWin®, a Windows-based Sleep Software Platform

Used in most systems including the review stations, Grass offers a search and query database manager as part of its standard offering. Other software options include an EMR/HL7 interface, a patient scheduling application, and frequency analysis trending software. Intralab scoring comparison and on-the-fly interpretation report building help complete the TWin software offering.