Catalog - Atos Medical

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Catalog

What is Trismus?The lower jaw incorporates important muscles, joints,and teeth vital for chewing, speaking, swallowing,and making facial expressions. Reduced ability toopen the mouth or pain when opening the mouthmay be a sign of Trismus.Trismus is a serious yet frequently overlookedcondition that may appear at any age and canprogress slowly. Early detection and rehabilitation canhelp patients counter this restrictive condition andprevent sometimes costly complications which maycompromise a patient’s quality of life and health.2

Who is affected?Trismus can be divided into two types: one wherethe soft tissues are damaged and one where thebones, muscles or joints are affected. Possible causesof this condition include but are not limited to thefollowing: Head and neck radiation Scarring resulting from head and necksurgery Complications from surgery Temporomandibular Joint Disorders (TMJD) Other muscle disorders Joint fixation (ankylosis) Joint inflammation (arthritis) Trauma, e.g., fractures Stress-induced disorders, e.g., clenching andgrinding of the teeth (bruxism) Stroke BurnsPatients suffering from trismus can be foundwithin many clinical disciplines, including speechand language pathology, radiation oncology,maxillofacial surgery and prosthodontics,otolaryngology, physical therapy, and dentalsurgery.Why is Trismus a problem?Trismus can make it difficult for you to eat, speak,yawn, laugh, or clean your teeth. These difficultiescan occur at a time when proper nutrition andoral hygiene are particularly important for yourrecovery. The absence of joint movement can leadto inflammation, causing the joint to stiffen andgradually lose its function. If not treated promptly3and properly, this hidden disability can seriouslyaffect your recovery, health, and quality of life.How do I know if I have Trismus?The average mouth opening in adults is around45 mm. If you experience problems in your dailylife because you cannot open your mouth wideenough, or if you have pain in your jaw, you mayhave trismus. The simplest way to test for Trismus isto insert three fingers between your upper and lowerteeth or dentures. If you can do this without pain ordiscomfort, your jaw mobility is most likely normal.If you can only manage 1 or 2 fingers, it could bethat you have Trismus. A quick and easy way tocheck your jaw mobility is our handy, disposableTheraBite Range of Motion Scale.What can I do?

What can I do?Trismus is unlikely to get better spontaneously.With the condition slowly worsening over time, it isimportant to start rehabilitation as soon as possible.If rehabilitation is delayed, trismus becomes moredifficult to treat and reverse.Studies show that stretching combined withpassive motion is an effective way to improve jawmobility. Passive motion nourishes the joint withoutactivating painful muscles. The joint can alsoremain completely relaxed while an external force4moves the jaw through its natural range of motion.Exercise with the TheraBite System provides bothstretching and passive motion.Rehabilitation for trismus patients focuseson stretching the damaged tissues, the expectedrehabilitation outcome is an increased jaw openingof 1 – 1.5 mm per week.

TheraBite therapyNumerous clinical studies have demonstrated thebenefits of the TheraBite system. The system isdesigned to accomplish two treatment objectives:1. Increasing the range of motionof the jaw:Stretches connective tissueFibrous scar tissue causes tightening of muscle andjoints and requires stretching to re-align the collagenfibers within. Passive and repetitive stretching canhelp to lengthen and reform these fibers and does soin an anatomically correct fashion.Strengthens weakened musclesReduces muscle painMuscles that have suffered from disuse atrophyrequire strengthening across the full range ofmotion. Using passive range of motion exercises, theTheraBite system can help to increase muscle massand endurance. The device can also be squeezedgently to provide resistance while closing the mouthto strengthen the muscles.Muscle pain (myofascial pain) is usually causedby inflammation, which creates abnormal pressureon nerves, muscles, and bones. This inflammationprocess can be corrected through passive motionexercises. Passive motion and stretching with theTheraBite system has been proven to reduce jointand/or muscle pain in as little as two weeks oftherapy.Mobilizes jointsJoints that are immobilized can undergodegenerative changes in a matter of days. Passiverepetitive motion, such as that provided withThe TheraBite system, can help to mobilize thetemporomandibular joint across its full range ofmotion via passive motion.2. Pain reductionReduces joint inflammationImmobilized joints lead to thickening of the synovialfluid and thinning of cartilage. This stiffening of thejoints ultimately leads to inflammation and pain.Passive motion of the joint, such as that providedwith the TheraBite system, can activate anti-inflammatory agents that promote joint lubrication andreduce inflammation and pain.5

Exercise programsA rehabilitation program is chosen by the health careprofessional prescribing the device, according to themedical condition of the patient. A typical patientwill gain 1-4 mm of jaw opening ability in the firstsession; however, this gain is likely to be lost withinthe next few hours. Long lasting benefit can only beachieved by repeating the exercises several times perday. Increased pain during the exercises should beavoided, as it can result in muscle guarding that mayimpair the effectiveness of the therapy and reducecompliance.The average sustainable gain is around 1–1.5 mmper week. Thus, to achieve 10 mm of sustainablegain, a patient may need to exercise from six toten weeks. The number of daily exercise sessionswith the TheraBite system typically decreases overtime. Ultimately, many patients are usually able tomaintain the gain they have achieved by using thedevice just once or twice a day.1Place mouthpieces comfortablybetween teeth.67-7-7A commonly used treatment program is “7-7-7”;7 stretches performed 7 times per day, with eachstretch held for 7 seconds. Although repetition iscrucial, this program takes no more than 10 minutesper day.5-5-30Patients who suffer muscle and/or joint pain maybenefit from an exercise regimen with longerstretches: 5-5-30, 5 stretches performed 5 times perday or more, with each stretch held for 30 seconds.Monitoring by clinicianRegular monitoring, review, and evaluation by aclinician is essential for all rehabilitation programs.Depending on a patient’s condition and thejudgment of his/her clinician, the type of programrequired may be modified over time.2Squeeze the lever to the point ofresistance and hold.3Slowly close the mouth andpause.

Benefits of using the TheraBite SystemAnatomically correctEffectiveA unique feature of TheraBite system is its ability tofollow the naturally curved motion of the jaw. Thecurved track of the TheraBite Jaw Mobilizer guidesthe mandible along an anatomically correct pathway.Passive motion and stretching exercises with theTheraBite system are clinically proven to be aneffective form of jaw therapy. It has been used withsuccess by thousands of patients suffering frommore than 30 different conditions, ranging frompostradiation Trismus to orofacial pain.Patient controlledWhen using the TheraBite system, the patient is incontrol. Speed and opening range can be adjusteddirectly by the patient, using manual force, or theFine Adjustment Knob. This feature helps to reduceanxiety levels and improve compliance.PortableThe TheraBite system is durable and lightweight.It can be conveniently stored in the Carrying Bagprovided for patients to continue their rehabilitationprogram wherever they go.Load-bearing comfortThe mouthpieces are attached to the Jaw Mobilizerand are designed in such a way that the load-bearingforces of stretching spread across the teeth. This,together with the Bite Pads, promotes a comfortableand even stretch while protecting the patient’s teeth.7For all agesThe TheraBite Jaw Motion Rehabilitation System isavailable in both adult and pediatric versions. Thepediatric version has smaller mouthpieces that aremore suitable for patients with a smaller mouth.

The TheraBite Jaw MotionRehabilitation SystemThe TheraBite Jaw Motion Rehabilitation System is a portable system which utilizes repetitive passivemotion and stretching to restore mobility and flexibility of the jaw musculature, associated joints andconnective tissues. It is a clinically proven, effective system that helps to increase mouth opening anddecrease pain.Bite PadsThe self-adhesive Bite Padsspread the force across theteeth and can be trimmedfor customized protection.The Bite Pads come in adult,pediatric and edentulous(toothless) versions.Range of Motion Scales4.6 cm6 cm8The disposable Range of MotionScales allows the patient and his/her clinician to monitor theprogress of the treatment.

Range Setting ArmCarrying BagThe durable nylonCarrying Bag keeps theTheraBite system together.The position of the RangeSetting Arm can be adjustedto 25-45 mm and is used todetermine maximum openingappropriate to each stage ofrehabilitation.Exercise LogThe daily and monthlyExercise Log enables theuser and his/her treatingclinician to log the dailyand monthly progress.Fine Adjustment KnobThe Fine AdjustmentKnob can be used toadjust opening distanceif needed.TheraBite Jaw MobilizerThe TheraBite Jaw Mobilizerprovides patients with ananatomically correct jaw motion.9Hand-AidThe Hand-Aid assists thepatient in maintaining constantopening during stretching orstrengthening programs.

TestimonialsDr. M. BengtssonMargaretha NilssonDr. B. StackJaw / Maxillofacial Surgeon,Jaw Surgery,Skåne University HospitalLund , SwedenDental hygenist, JawSurgerySkåne University Hospital,Lund , SwedenDepartment of Otolaryngology, Head and Neck Surgery,University of Arkansas Center for Medical Sciences, LittleRock, AR, USA“We think that TheraBite is a good medical device,as it enables an even pressure on the bite and jawduring use. Thereby we can feel safe to start trainingthe jaw flexibility earlier after surgery, already afterabout two weeks instead of six weeks. The use is easyto explain to our patients and good instructions areincluded, both for us as doctors, who hands it outand for the patients.We get very good results with TheraBite,especially for patients who had radiation therapy andreconstructive surgery.”Prof. W. MendenhallDr. AP Slagter & Dr. CHG BeurskensDepartment of Radiation Oncology, University of FloridaHealth Science Center, Gainesville, FL, USASpecial Care Dentisty, the Netherlands“While treating patients with radiation for head andneck cancer, we have noted a meaningful numberof cases of trismus. We have tried many differentapproaches to the treatment of this condition, butare most impressed with the results of the TheraBitesystem. It is easy for patients to use, and offersconsistently positive results.”10“I have used the TheraBite device in a variety ofpatients, including patients suffering frompostsurgical and post-radiation trismus, as well as onTMJ patients. The typical patient responds wellto the device, showing significant improvementin function. While rehabilitation does take sometime and effort, it is encouraging to many patients,who find that they can resume eating and speakingproperly.”“TheraBite is very much utilized at our center bypatients who suffer from limitations in mandibularopening following surgery and cancer. Theexperience with TheraBite is very good, especiallybecause the patients can exercise at theirown pace.”

Insurance andReimbursement(USA only)Atos Medical can help you with your insurance filingneeds with no additional cost to you.Many private insurance companies may cover theTheraBite system. Please note that each insuranceplan is individualized regarding insurance coverage,payment, co-payments and deductibles. Somerestrictions apply, depending on medical need.The TheraBite is designed for single patient use,and by this definition does not qualify for Medicarecoverage. Accordingly, Medicare requires you tocomplete an Advance Beneficiary Notice (ABN) inorder to purchase the device.For further information about the TheraBitesystem and potential insurance coverage, pleasecontact your Atos Customer Service Representativesat 1.800.217.0025 or visit:www.therabite.com.Patient information forms, prescription forms, andcertificates of medical necessity can be sent to youupon request or you can download them from thewww.atosmedical.us webpage.How can I order?You can call, e-mail, fax or order on-line at:Atos Medical Inc.Tel:1.800.217.0025Fax:1.414.227.9033E-mail: therabite.us@atosmedical.comwww.atosdirect.com11

Order InformationProduct nameQuantityREFTheraBite Jaw Motion Rehabilitation System , Adult1 pcTH001TheraBite Jaw Motion Rehabilitation System , Pediatric1 pcTH002The TheraBite Jaw Motion Rehabilitation System contents: The Jaw Mobilizer Bite Pad Hand-Aid Range of Motion Scale Carrying Bag Instructions for Use Exercise Log1 pc4 pcs1 pc30 pcs1 pc1 pc1 pcTheraBite Range of Motion Scale150 pcsSC001TheraBite Bite Pad, Regular4 pcsPA001TheraBite Bite Pad, Edentulous4 pcsPA002TheraBite Bite Pad, Pediatric4 pcsPA0031 pc7840 (PAL)7840-N (NTSC)TheraBite Instructional DVDThis 14-minute film provides useful information on trismus and demonstrates thefunctions and benefits of the TheraBite system. This DVD is divided into severalchapters and features testimonials from a former patient and two clinicians.Available in English only.References1.Bandy WD, Irion JM. The effect of time on static stretch on the flexibilityof the hamstring muscles. Phys Ther 1994;74(9):845-850.2.Buchbinder D, Currivan RB, Kaplan AJ, Urken ML. Mobilization regimens forthe prevention of jaw hypomobility in the radiated patient: a comparisonof three techniques. J Oral Maxillofac Surg 1993;51(8):863-867.3.12. Kamstra JI, Roodenburg JL, Beurskens CH, Reintsema H, Dijkstra PU. TheraBiteexercises to treat trismus secondary to head and neck cancer.Support Care Cancer 2012.13. Kent LM, Brennan MT, Noll JL et al. Radiation-induced trismus in headand neck cancer patients. Support Care Cancer 2008;16(3):305-309.Carnaby-Mann G, Crary MA, Schmalfuss I, Amdur R. “Pharyngocise”:Randomized Controlled Trial of Preventative Exercises to Maintain MuscleStructure and Swallowing Function During Head-and-NeckChemoradiotherapy. Int J Radiat Oncol Biol Phys 2011.14. Maloney GE, Mehta N, Forgione AG, Zawawi KH, Al-Badawi EA, Driscoll SE.Effect of a passive jaw motion device on pain and range of motion in TMDpatients not responding to flat plane intraoral appliances.Cranio 2002;20(1):55-66.4.Cohen EG, Deschler DG, Walsh K, Hayden RE. Early use of a mechanicalstretching device to improve mandibular mobility after composite resection:a pilot study. Arch Phys Med Rehabil 2005;86(7):1416-1419.15. Melchers LJ, Van WE, Beurskens CH et al. Exercise adherence in patients withtrismus due to head and neck oncology: a qualitative study into the useof the Therabite. Int J Oral Maxillofac Surg 2009;38(9):947-954.5.Cohen G, Fletcher M. Comparison of Jaw Mobilization Regimens. Journalof Dental Research 1991; 70: 329.6.Dijkstra PU, Kalk WW, Roodenburg JL. Trismus in head and neck oncology:a systematic review. Oral Oncol 2004;40(9):879-889.16. Messing G, Saunders J, Dietrich-Burns K, Farrell S, Pyrke-Fairchild J, Melick C.Trismus management in the head and neck cancer patient undergoing organpreservation treatment. 6th International Conference on Head and NeckCancer , 01-97. 2004. Washington DC, USA.7.Dijkstra PU, Huisman PM, Roodenburg JL. Criteria for trismus in head andneck oncology. Int J Oral Maxillofac Surg 2006;35(4):337-342.8.Dijkstra PU, Sterken MW, Pater R, Spijkervet FK, Roodenburg JL. Exercisetherapy for trismus in head and neck cancer. Oral Oncol 2007;43(4):389-394.9.Fernandez FM, Fernandez SJ, Sandoval GJ, Costas LA, Lopez de SA,Etayo PA. Treatment of bilateral hyperplasia of the coronoid process ofthe mandible. Presentation of a case and review of the literature.Med Oral Patol Oral Cir Bucal 2008;13(9):E595-E598.10. Gibbons AJ, Abulhoul S. Use of a Therabite appliance in the managementof bilateral mandibular coronoid hyperplasia. Br J Oral Maxillofac Surg2007;45(6):505-506.11. Jager-Wittenaar H, Dijkstra PU, Vissink A, van Oort RP, Roodenburg JL. Variationin repeated mouth-opening measurements in head and neck cancer patientswith and without trismus. Int J Oral Maxillofac Surg 2009;38(1):26-30.17. Scott B, Butterworth C, Lowe D, Rogers SN. Factors associated with restrictedmouth opening and its relationship to health-related quality of life in patientsattending a Maxillofacial Oncology clinic. Oral Oncol 2008;44(5):430-438.18. Tang Y, Shen Q, Wang Y, Lu K, Wang Y, Peng Y. A randomized prospective studyof rehabilitation therapy in the treatment of radiation-induced dysphagia andtrismus. Strahlenther Onkol 2011;187(1):39-44.19. Teguh DN, Levendag PC, Voet P et al. Trismus in patients with oropharyngealcancer: relationship with dose in structures of mastication apparatus.Head Neck 2008;30(5):622-630.20. van der Molen L, van Rossum MA, Burkhead LM, Smeele LE, Rasch CR,Hilgers FJ. A randomized preventive rehabilitation trial in advanced head andneck cancer patients treated with chemoradiotherapy: feasibility, compliance,and short-term effects. Dysphagia 2011;26(2):155-170.Thanks to Sofiero Slottsträdgård, Helsingborg, Sweden, where the pictures in this brochure are taken.Atos Medical’s products and expertise are developed in close cooperation with leadinginstitutions, doctors, researchers, speech language pathologists and patients from all over theworld. Our claims and arguments rest on the results of clinical studies. Atos Medical startedthe research and development on the first Provox voice prosthesis in 1987. Throughoutthe years, we have worked hard to develop Provox as the leading voice and pulmonaryrehabilitation system on the market. We continue to allocate substantial resources for productdevelopment and training programs for Ear, Nose and Throat specialties. Our goal is clear:Atos Medical will continue to lead the way in ENT.Asia-Pacific:Atos Medical ABLevel 16, Man Yee Building,60-68 Des Voeux Road,Central, Hong KongTel: 852 3796 2761info.hk@atosmedical.comBelgium:Atos Medical BVBA / SPRLKoningsstraat 266 Rue RoyaleBE - 1210 Brussel / BruxellesTel: 32 (0)2 218 55 Atos Medical S.A.S.3, rue de RobinsonFR-92220 BagneuxTel: 33 (0)1 49 08 01 :Atos Medical GmbHMülheimerstr. 3-7DE - 53840 TroisdorfTel: 49 (0)2241 14 93 - 0info.de@atosmedical.comwww.atosmedical.deThe Netherlands:Atos Medical B.V.Postbus 574NL - 2700 AN ZoetermeerTel: 31 (0)79 593 :Atos Medical Spain S.L.C/Aragón, 208-210, 3º1ª08011 BarcelonaTel: 34 (0)93 323 erland:Atos Medical, SwitzerlandSeefeldstrasse 358008 ZürichTel: 41 (0)44 380 60 aton Medical LtdP.O. Box 2568, EastbourneEast Sussex BN21 3HZTel: 44 (0)1323 431 930platonmedical@mistral.co.ukU.S.:Atos Medical Inc.11390 West Theodore Trecker WayWest Allis, WI 53214-1135Customer Service: 1 (0)800 217 0025info.us@atosmedical.comwww.atosmedical.usHead office:Atos Medical ABP.O. Box 183, SE-242 22 Hörby, SwedenTel: 46 (0)415 198 00 Fax: 46 (0)415 198 98info@atosmedical.com www.atosmedical.com Atos Medical AB, 201410A, REF 7827US

Dr. B. Stack Department of Otolaryngology, Head and Neck Surgery, University of Arkansas Center for Medical Sciences, Little Rock, AR, USA “I have used the TheraBite device in a variety of patients, including patients suffering from postsurgical and post-radiation trismus, as well as on

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