Patientenaufklärung

Gründe für die Diskus Dehydration: Veränderungen des hydrostatischen Drucks Zu niedriger Sauerstoffgehalt Zu niedriger Glukosegehalt Veränderungen des PH-Werts Note: 3 Slides Combined: Slide 1 - If the cells of the disc failed to get proper nutrients - such as oxygen, or glucose - or if the pH level of the disc drops (because waste is not being diffused out of the disc and it becomes anaerobic), disc cells would die and stop producing the vital proteoglycan aggregates. The disc loses its water content (dehydrates) and loses its hydrostatic pressure (osmotic pressure). NEXT SLIDE: Both Handa et al. (1) as well as Ishihara (2) have concluded experimentally that disc cells are very picky about the amount of hydrostatic pressure that they can function in.   They thrive at 3 atm of hydrostatic pressure, which just happens to be the normal pressure of a non-degenerated disc.   Any variation in that pressure, EITHER higher (>30 atm) or especially lower (< 1 atm) will stop that disc from functioning (making proteoglycan which hold water within the disc). Next Slide: Poorly vascularized intervertebral discs tend to undergo degeneration of their internal structure at a surprisingly early age. In fact, research has demonstrated such degeneration usually begins within the first decade of life! “ Urban JPG, McMullin JF, "Swelling pressure of the lumbar intervertebral discs: influence of age, spinal level, composition and degeneration." Spine 1988, 13:179-187 Handa T, et al. "Effects of hydrostatic pressure on Matrix Synthesis and MMP production in the human lumbar intervertebral disc." Spine 1997 ;22:1085 -1091 Classification of Age-Related Changes in Lumbar Intervertebral Discs 2002 Volvo Award in Basic Science" Spine 2002; Volume 27, Number 23, pp 2631-2644 2

Verfügbare Therapien für diskogene Patienten Medikation und eingeschränkte Aktivität Physiotherapie / Physikalische Therapie Schmerztherapie Operation SpineMED Decompression

SpineMED® Decompression As I said this is a non-invasive way to address disc pathology. The goals of this treatment are not new. Eine NEUE, nicht-invasive Methode zur konservativen Behandlung von Bandscheibenproblemen und diskogen verursachten Schmerzen. 4

Wie funktioniert SpineMED® Decompression? Beschädigte Bandscheiben heilen selten, weil sie unter ständigem Druck stehen, sogar wenn sich der Betroffene ausruht. SpineMED® Decompression ist dahingehend entwickelt worden, den Druck im Wirbelzwischenraum zu reduzieren, indem die Wirbelkörper behutsam auseinander gezogen werden. Durch diese Distraktion wird der Druck auf die Bandscheibe verringert und es wird Flüssigkeiten, Nährstoffen und Sauerstoff ermöglicht, in die Bandscheibe zu gelangen. Dieser Austausch von Nährstoffen hilft den körpereigenen Heilungsprozess zu unterstützen und kann die beschädigte Bandscheibe wieder aufbauen. Darüber hinaus kann eine Reduzierung des intradiskalen Drucks dabei helfen, den Nukleus bei einem Bandscheibenvorfall wieder zu zentrieren. Hierbei wird der Druck auf einen zusammengedrückten Nerv entlastet und die Schmerzen verschwinden.

Ziele der SpineMED® Behandlung Distraktion der Wirbelsäule um den Zwischenwirbel-Abstand zu vergrößern Verringerung des intradiskalen Drucks Verbesserung des Stoffwechsels (Flüssigkeit, Wasser, Nährstoffe) Repositionierung von Bandscheibengewebe

Funktion der Bandscheiben im Körper Bandscheiben dienen der Wirbelsäule als Stoßdämpfer ermöglichen die Beweglichkeit unterteilen die Wirbel um einen Nervenausgang zu ermöglichen Weiteres siehe in folgender Animation:

Bandscheiben dienen der Wirbelsäule als Stoßdämpfer,

…ermöglichen die Beweglichkeit,

… unterteilen die Wirbel um einen Nervenausgang zu ermöglichen.

Blick in eine gesunde Bandscheibe

Aufnahme von Nährstoffen aus der Umgebung

Erhöhter Druck auf die Bandscheiben verlangsamt den Regenerierungsprozess

… und führt zu Dehydrierung und Degeneration der Bandscheiben.

Mögliche Folge: Nervenwurzelkompression

Komprimierung des Nervs führt zu Rückenschmerzen

Durch dynamische Distraktion mit dem SpineMED wird der Druck auf die Bandscheiben reduziert …

… und die Selbstheilung wird angeregt.

Indikationen einer SpineMED® Behandlung Potenzielle OP-Patienten Bandscheibenvorwölbung/-vorfall, Ischialgie Diskus Degeneration, Facettengelenkssyndrom Radikulärer Symtomatik LBP, HWS-Schmerzen Chronische Schmerzpatienten Unbefriedigendes OP-Ergebnis “Auf wie viele Ihrer Patienten treffen diese Indikationen zu?” 19

Gegenindikationen einer SpineMED® Behandlung Tumore Starke Osteoporose Instabile Spondylolisthesis Pathologische Läsionen oder congenitale Deformationen der WS Aktuelle Fraktur Entzündliche Erkrankungen Cauda Equina Post-Operative Patienten mit Metallimplantaten Schwangerschaft Patient jünger als 15 Jahre Osteoporosis – severe > 45% bone loss Spondylolithesis- grade 2 or greater Pathological lesions – that disrupt integrity of vertebral and ligamentous structures Fractures- within one year even compression Inflammatory diseases – such as rheumatoid arthritis, ankylosing spondylitis Connective tissue diseases – such as scleroderma Cauda equina syndrome Post surgical patients – that have hardware in place or just need time for healing 6- 12 months.

Abwehrspannung (Guarding Reflex) & Biofeedback Response Gewöhnliche Traktion führt zu muskulärer Abwehrspannung (natural guarding reflex) Dieses Gegenspannung verhindert eine Distraktion der Wirbelsäule Herkömmliche Traktionsgeräte sind nicht in der Lage diese körperliche Gegenreaktion zu umgehen. Eine effektive Distraktion wird nicht möglich. Biofeedback Respones System: SpineMED misst diese Abwehrspannung und adaptiert die Zugbelastung um die natürlichen muskulären Reflex- mechanismen auszuschalten. If muscles are actively engaged in resisting the distraction, we’re not going to realize a change in disc pressure. Previous devices did not have the ability to measure or react to patient response. In fact, one of the pitfalls with conventional traction is that the patient’s guarding reflex often ‘over-reacts’ – sending them into spasm. (next slide) 21 21

Negativer Intradiskaler Druck Durch Erhöhung der Zugkraft nimmt der intradiskale Druck ab:

SpineMED Patienten MRI vorher/nacher As you can see on these pre and post MRI’s a Reduction of disc bulge Increase in disc height and hydration content There’s some exciting research going on that is very encouraging. September 2006 Januar 2007, 4 Monate nach der SpineMED-Kur 23

Decompression Research 71% of 778 cases were successful in reducing pain to a 0-1 on a 0-5 pain scale. 86% of 219 patients demonstrated success according to Oswestry Pain Scale; 84% remained pain-free at 90 day follow up. 91% of 14 patients with radiculopathy and abnormal sensory function demonstrated improved neurological function. 50% -100% reduction of pain was reported in 19 out of 23 pts with ruptured intervertebral discs and 20 out of 27 with facet arthrosis The research done to date is very encouraging, typically showing between 70%-85% success rates. Personally, we see >90% in our clinic. And the research is continuing to confirm these statistics. SpineMED is leading the way with the ‘gold standard’ – the first and only randomized, double-blind study done through an IRB with the SUNY research foundation. Not only will we have strong subjective measurements in changes in pain and improvement in oswestry scores, but each of these patients will have the objective finding of pre and post MRIs…So now we have another option to treat disk disease. Earl Gose, et al., “Vertebral Axial Decompression Therapy for Pain Associated with Herniated or Degenerative Discs or Facet Sysdrome: An Outcome Study." Journal of Neurological Research, Vol 20, 13:179-187 Thomas Gionis, MD, et al., “Spinal Decompression" Orthopaedic Technology Review. 2004 Frank Tilaro, M.D., et al., “Vertebral Axial Decompression on Sensory Nerve Disfunction" Journal of Neuro-imaging, 1998; Volume 8, Number 2 Shealy, et al., “New Concepts in Back Pain Management. Decompression, Reduction and Stabilization”. Pain Management. 1998 239-257 24

Vorteile für SpineMED® Patienten Überspielt Körperabwehr-Refelxe Zielgerichtete Distraktion Fixierte Distraktion Geringere Kräfte wirken auf den Körper ein Grössere Nachhaltigkeit der Behandlung Passend für alle Patientengrössen, kein Geschirrzeug notwendig Wiederholbare Behandlungen Sehr komfortabel Eingebautes Unterhaltungssystem

Vorteile für Ihre SpineMED® Patienten und die Praxis Effektivere Behandlung der Rückenpatienten Alleinstellungsmerkmal (USP/Unique Selling Proposition) Grösseres Leistungsspektrum Patienten Neuakquise Maximierung des Praxispotenzials Bedienung der Nachfrage nach konservativen und schonenden Heilverfahren

Funktion & Ausführung des SpineMED® Table Die 3. Generation einer Distraktionsliege Verbesserte Positionierung und Fixierung der Patienten Kann die spezifischen Wirbelzwischenräume isoliert behandeln Verbesserte klinische Effizienz The SpineMED system was designed to be the most effective and clinically efficient decompression system on the market. We made significant improvements to the restraint system, the ability to isolate specific spinal segments and computerization to create the most sophisticated decompression device available.

Entwicklung & Technologie SpineMED® Table Früher: Traditionelles Gurtzeug (-) Zeit- und arbeitsintensiv (-) Unkomfortabel (-) Patienten können herausrutschen (-) Ungenügende Reliabilität Heute: Becken Fixierungs- System beim SpineMED (++) Sicherer Halt (++) Wiederholbar (++) Komfortabel (++) Eliminiert Rausrutschen (++) In 2 Min. eingerichtet One of the most obvious points of frustration was the old nylon harness system. Getting the patients set up for a session on the 2nd generation table was time and labor intensive, taking between 8-10 minutes per patient. As well, the way that the harnesses were positioned and tightened would add a great deal of variability from one treatment to the next. If the harness was secured higher or lower on the pelvis, or tighter or looser from one session to the next, it would have a significant impact on the area of the spine that was targeted and the patients would complain that the sessions felt different. In offices with multiple technicians patients would even request certain employees – “I’d like Jim to set me up; Nancy doesn’t get the harness tight enough”. From the technicians perspective, one of the most frustrating aspects of the older system was the fact the no matter how tight you secure the pelvic harness, they tend to slip down over the hips once the session ramps up to full tension. At this point, after already spending 10 minutes to get the patient set up to begin with, you have to stop the treatment, reset the harnesses and re-start the device to ensure an effective session. Patients often complained that the harnesses were too tight and uncomfortable. The solution… …. Was to eliminate the old nylon harnesses and create a simple, yet amazingly effective restraint system using gel padded pelvic horns. It is difficult to demonstrate just how comfortable these are compared to the traditional nylon harnesses. The gel padding disperses the force evenly around the pelvis and the restraints are tilted in such a way that it requires very little tightening to get a secure capture. The patented pelvic restraints eliminated the variability of the old harness system. We can now achieve a secure capture the skeletal structure in a comfortable and repeatable manner. Plus, once the patient is set up it is physically impossible for them to slip through the restraints. This reduces the set up time from 10 minutes down to 2! and frees the technician to see other patients or perform other responsibilities while the patient runs through the automated SpineMED session. This increase in clinical efficiency and ease of use alone allows you to see 2-3 more patients per day during the same operating hours. Extrapolated over the first year and that increase in patient flow will more than pay for the entire system!

Entwicklung & Technologie SpineMED® Table Verbesserte Positionierung/Fixierung Früher: Tower & Beckengurt Design (-) Energieverlust durch vertikale Vektoren (-) Hebt den Patienten vom Tisch (-) Gurtzeug gibt nach Heute: SpineMed Pelvic Tilt - Design (++) Justiert den Patienten in der richtigen Position (++) Isoliert effektiv die Segmente der Wirbelsäule (++) Reduziert die benötigte Kraft (um 60%) The next area of improvement was in the ability to isolate specific spinal segments. On the tower and harness design, this was accomplished by raising the decompression head up the tower to change the angle of distraction to the pelvis. However, as the angle becomes steeper you start to loose energy to the vertical vectors – combating the patients body weight in lifting them Up off the table as opposed to keeping all of that energy in the horizontal plane to distract the spine. You also, again, run into the variability of the pelvic harness. Through the pelvic tilting section of the SpineMED, we can actually change patient positioning ; tilting the pelvis to effectively move the focal point of treatment further up the lumbar spine. Once the hips are captured and the pelvis positioned, the lower end of the table separates to distract the spine and open the desired disc space. All of the energy is still being applied in the horizontal plane. This increase in specificity, combined with the improved restraint system results in lower force requirements that previous technologies – About 60% of the forces needed with the tower and harness design. This means that a 200 lb patient treating on the DRX would expect decompression forces of between 90-130lbs. That same patient, same pathology would achieve results on the SpineMED system between 40-70lbs. The SpineMED’s ability to achieve results using lower forces dramatically increases the scope of patient suitability, particularly with acute patients or the growing geriatric population.

Entwicklung & Technologie SpineMED® Table Biofeedback Response Früher: Tower & Beckengurt Design (-) 1-2 Sekunden Reaktionszeit (-) Nylon Strech Faktor (-) Energie-Verlust und –Absorbtion (-) Reíbungsverluste im Transfersystem Heute: SpineMed Pelvic Tilt (++) Nur 20 ms Reaktionszeit (++) Unmittelbarer Energietransfer (++) Direkte Erfassung (++) Verbesserte Isolation

Entwicklung & Technologie SpineMED® Table Fortschrittliche Computerbedienung Touch Screen Protokolliert Berechnungen Automatisches Reporting Upgrades können remote erfolgen

Pressestimmen Bild der Frau 22.01.10