WO2011145069A1

WO2011145069A1 - Non-invasive method of spinal intervention and use of devices effective for spinal intervention

Info

Publication number: WO2011145069A1
Application number: PCT/IB2011/052190
Authority: WO
Inventors: Geoffrey T. Desmoulin; Christopher J. Hunter
Original assignee: Optima Heath Solutions International Corporation
Priority date: 2010-05-19
Filing date: 2011-05-19
Publication date: 2011-11-24
Also published as: WO2011145069A4

Abstract

A non-invasive spinal and upper cervical impulse treatment device comprising a stylus configured to apply a repetitive sinewave impulse on a vertebrae of a patient within specified ranges of feree, acceleration and frequency, the stylus also configured to allow alignment with a treatment vector derived by a processor. The device is integrated within an assembly comprising a body imaging device, a processor, a controller and an actuator. The preferred ranges for the impulse characteristics are: a force within the range of 5.5 to 12.2 Newtons, preferably within the range of 8 to 12 Newtons, a shear acceleration within the range of 0.5 to 5 g, preferably below 2.2 g, and a frequency within the range of 5 to 175 Hertz, preferably between 50 and 110 Hertz. Treatment conditions may be varied depending upon the size of the patient, which includes human and veterinary patients.

Description

NON-INVASIVE METHOD OF SPINAL INTERVENTION AND USE OF DEVICES EFFECTIVE FOR SPINAL INTERVENTION

Technical Field

The present technology is related to an apparatus and uses of the apparatus for spinal intervention in the treatment of patients. More specifically, the technology relates to a non-invasive treatment using an impulse delivery device and the apparatus therefore.

Background Art

-Disc Degeneration:

Chronic back pain is a significant health problem associated with degeneration of the intervertebral discs . Traditionally, treatment is varied and focused on the symptoms instead of at the root of discogenic back pain, the disc itself. The more conservative approaches include general exercise, specific conditioning of back and abdominal muscles to help stabilize hyper-mobile regions , spinal manipulation to increase the range of motion for hypo-mobile regions, massage therapy, and transcutaneous electrical nerve stimulation. The more invasive treatments involve the use of medications such as analgesics, opiates, anticonvulsant agents, or antidepressants; minimally invasive treatments such as acupuncture, epidural, and facet joint corticosteriod injections, and spinal nerve blocking techniques. The most invasive treatments involve surgical intervention, ranging from microdiscectomy and spinal fusion to laminectomy.

Despite the multitude of treatments and clinical studies, discogenic back pain still remains one of the most elusive ailments of our time and lacks standardized guidelines for treatment that uniformly achieve acceptable results. In fact, within the framework of evidence-based medicine, the best treatment for discogenic back pain remains cognitive intervention combined with physical exercises specific for stabilizing the spine.

The mechanical properties of the intervertebral discs play an important role in their functionality. Disc degeneration is often characterized by reduced disc height and increased stiffness, leading to bulging or herniation which can create pressure on the radiating nerves and spinal cord. The dominant treatment at present is spinal fusion, wherein two or more adjacent vertebral bodies are physically locked together using bone graft or instrumentation. While this procedure often successfully eliminates stenosis and restores disc height, thus reducing nerve pressure, degeneration of adjacent motion segments is a common long-term complication through negative changes in joint dynamics.

-Mean Axis of Rotation:

Patients with neck pain typically do not exhibit obvious abnormalities in plain neck radiographs. Noting the lack of effectiveness of neck range of motion investigations, investigators began exploring the notion of the quality of motion of the cervical vertebrae, they reasoned that while range of motion may be normal, abnormalities of the cervical spine might be revealed by abnormal motion patterns within individual joints. When a cervical vertebra moves from full flexion to full extension, its path appears to lie along an arc whose center lies somewhere below the moving vertebra, this center is called the mean axes of rotation [MAR] or Instantaneous Axis of Rotation [IAR]and its location can be determined using geometry. van Mameren et al. (1992) showed that in contrast to cervical range of motion, a given MAR can be reliably calculated within a small margin of technical error (11).

-Abnormal Mean Axes of Rotation:

Abnormal MARs were investigated by Amevo et al. (1992), who studied 109 patients with post-traumatic neck pain (13). The MAR locations were subsequently compared with previously determined normative data. It emerged that 72 percent of the patients with neck pain exhibited at least one abnormally located cervical MAR. The relationship between axis location and pain was highly significant statistically [P<0.001]. However, there was no evident relationship between the segmental level of an abnormally located MAR and the segment found to be symptomatic on the basis of provocation discography or cervical zygapophysial joint blocks.

-Gene Expression in the Nucleus Pulposus:

The intervertebral discs (IVDs) provide mobility and a degree of shock absorbance to the spinal column. They also transmit forces between the adjacent vertebrae and prevent direct contact between the bones. It has been shown that the mechanical properties of the intervertebral discs play an important role in their functionality. Disc degeneration is often characterized by reduced disc height and stiffness, resulting in pressure on the radiating nerves. The dominant surgical treatment at present is spinal fusion, wherein two or more adjacent vertebral bodies are physically locked together using bone graft or instrumentation. While this procedure often successfully restores disc height and allows for the return of a pain-free lifestyle, degeneration of adjacent motion segments (adjacent segment disease) is a common long-term complication. While initially thought to be a rare event, adjacent segment disease is becoming more of a concern. One current theory states that by fusing dynamics of the joint, they are altered in a way that affects the healthy discs next to the fused segment, likely by altering loading and kinematics on these adjacent discs.

-Vibration Treatment:

Vibration treatment has been used for centuries for the treatment of various ailments. Initially, treatment was provided with bare hands. As it became evident that a more controlled method of treatment was needed, devices and protocols were developed to provide a controlled vibration. As a result, we now have methods for increasing bone density, for reducing pain associated with osteoarthritis and soft tissue injury and for reducing lower back pain, to name a few. For example, McLeod (5376065) disclosed that sinusoidal waves having a frequency of 10-110 Hz with an amplitude of 0.01-2 mm and an acceleration of 0.05-.5 g can improve bone density in patients. Mathes (US Publication No. 20100121131) disclosed that any waveform ranging in frequency from 1-146 Hz with an acceleration of .05-.5 g can reduce pain associated with osteoarthritis and soft tissue injury. Desmoulin et al. (Journal of Musculoskeletal Pain, Vol 15, 3 pp 91-105) and Desmoulin et al. (Clinical Journal of Pain, Vol 23, 7, 576-585) disclosed the use of the Khan Kinetic Treatment (KKT) for reducing lower back pain. The treatment involved vibration at 80-120 Hz with a maximum displacement of 5mm, however, it was suggested that the frequency could range from 20-300 Hz. The treatment device used was disclosed in Khan (US Publication No. 20080312724). The device delivers multiple impulses of variable frequency and variable force in a linear direction, as well as rotational forces, for patient treatment. The apparatus produces smooth sinusoidal waveforms ranging from 50 to 110 Hz for treatment of spinal and upper cervical vertebrae.

Technical Problem

Technical Solution

In order to provide highly repeatable and accurate treatment of the skeleton, and more specifically the spine, an assembly is provided. The assembly comprises:

a body imaging device for creating images of a plurality of spinal vertebrae of the patient;

a processor for determining a treatment vector;

a device for treating the patient, the device comprising a stylus, a controller and an actuator for driving the stylus in a linear direction, the device configured to:

-allow for alignment of the stylus on the treatment vector and placement on a vertebrae of the patient;

-provide a repetitive sinewave impulse of having a force of about 5.5 N to about 12.2 N with a shear acceleration of about .5 g to about 5g at about 5 Hertz (Hz) to about175 Hertz. The assembly preferably includes a treatment table. The device preferably is configured to provide a frequency sweep of about 50 to about 110 Hz with an acceleration of about 0.5 g, at a force of 10.3 Newtons (N).

In another embodiment, a use of the device in the treatment of a patient is provided.

In yet another embodiment, a method of treating a patient in need thereof is provided, comprising:

imaging a plurality of spinal vertebrae;

determining a treatment vector;

locating a spinal vertebrae;

aligning a stylus along the treatment vector and positioning it on a vertebrae of the patient; and providing a repetitive sinewave impulse of a force of about 5.5 N to about 12.2 N with a shear acceleration of at most about 5 g at about 50 Hertz (Hz) to about 175 Hertz to the vertebrae.

In another embodiment, a method of promoting disc health is provided. The method comprises exposing at least one intervertebral disc to a repetitive sinewave impulse at a force of about 5.5 N to about 12.2 N, each sinewave impulse having an acceleration of about 0.5g to about 5 g, at 16 Hz followed by a sweep between about 50 to about 80Hz.

Advantageous Effects

Description of Drawings

Figure 1 is a side view of the assembly of the present technology.

Best Mode

Mode for Invention

The preferred spinal treatment device for use with the present technology is disclosed in CA2005/000353 to Khan et al. The assembly, generally referred to as 8 is shown in Figure 1. The assembly includes a body imaging device 9, for example, but not limited to, x-ray, magnetic resonance imaging (MRI) or computed axial tomography (CT) machines. A treatment device includes an impulse delivery mechanism comprising a stylus used to deliver waveforms of various frequencies, and amplitudes, both linearly and rotationally to the vertebrae of the spine. A stable stand 10 supports an arm or armature component 16, which in turn supports the impulse treatment device head 28. Arm 16 is slidably enclosed by sleeve 19. The stand 10 can raise or lower the arm 16 by a large retractable piston or linear actuator 12 that is operator controlled. The arm 16 is mounted at the top of the stand's piston 12 at a complex joint with three degrees of freedom, called the stand coupling 14. The transducer head can tilt in this direction but the arm cannot. The stand coupling 14 allows a tilt of the arm 16 off the horizontal plane, creating a roll angle. The arm 16 slides forward and back in sleeve 19 relative to the stand 10. Releasing a lock 21 allows arm 16 to rotate within sleeve 19. A groove' in arm 16 and a biased ball bearing in the interior cylindrical surface of sleeve 19 causes arm 16 to encounter the resistance of having to move the ball bearing out of the groove in arm 16 when rotating arm 16 relative to sleeve 19. A yoke 18 has two arm components, which curve around and attach to the device head 28 by means of dual pivot points 20 on either side of the device head 28. The yoke 18 is supported by arm 16. The yoke 18 is best seen in the top view of the apparatus in Figure IA. There is a manual locking mechanism 17 close to the pivot point 20 on one side of the device head 28. A touch screen 26 at the top of the device head 28 displays a user interface which is used for device positioning and control.

A collapsible stylus 30 protrudes from the device head 28 and its end point 34 is used to deliver impulses to a predetermined contact point 35 on a patient's body 32. The point of contact 35 may be the top or atlas vertebra, behind the ear, as shown in Figure 1. The patient 32 is lying on a treatment bed 44 and the desired contact point 35 is in a fixed location. The many components and degrees of freedom of the device head 28 mounting scheme described above in combination, allow positioning of the linear axis 36 of the device head 28 and collapsible stylus 30 in any direction in three dimensions (3D), while simultaneously keeping the end of the stylus end 34 at a desired fixed location in 3D. For treatment, this fixed location is the contact point 35 on the patient 32.

At the time of treatment, the linear axis of the stylus is in any selected angle 36 in 3D, and this angle is calculated relative to the vertical direction 8 in the preferred embodiment.

Also shown on Figure 1 is a remote computer 40, which can be any processor, which may be in any location and is not necessarily close to the treatment area. Patient data from x-rays and overlaid drawings or other drawings are digitized and input to the remote computer 40 by means of a graphics tablet 42 peripheral. Calculations are made in the remote computer 40 on the raw data and operating parameters are derived. These parameters are sent to the spinal and upper cervical impulse treatment device by means of any data communications link 38, such as a serial data link or wireless link.

Examples

Example 1:

Treatment of Human Lumbar Vertebrae

X-ray images or other images suitable for showing spinal alignment will be viewed prior to treatment. If images are not available, imaging will be conducted. A device having a stylus and a driver to generate a sinewave of about 5 Hz to about 200 Hz, more preferably about 8 Hz to about 150 Hz, still more preferably about 25 Hz to about 100 Hz and most preferably about 50 Hz to about 100 Hz will be located on the skin of a patient adjacent a lumbar vertebrae in the vicinity of the transverse process of the vertebrae. Treatment will be at a force of less than about 5 pounds, more preferably less than about 4 pounds and most preferably less than about 2.5 lbs (about 22 N, about 18 N and about 11 N, respectively). The average Z-axis acceleration will be about 2.2 g, but can range from about 1.7 g to about 5 g, including 3.65g. The treatment time will be at least about 2 minutes, more preferably 5 minutes, and can be as long as 10 minutes. Treatment may involve one session, two sessions or multiple sessions. The results will show at least one of reduced pain, reduced disability, increased mobility and increased alignment. X-ray images or other images suitable for demonstrating spinal alignment will be used to determine whether or not the treatment results in increased spinal alignment.

Example 2:

Treatment of Human Thoracic Vertebrae

X-ray images or other images suitable for showing spinal alignment will be viewed prior to treatment .If images are not available, imaging will be conducted. A device having a stylus and a driver to generate a sinewave of about 5 Hz to about 200 Hz, more preferably about 8 Hz to about 150 Hz, still more preferably about 25 Hz to about 100 Hz and most preferably about 50 Hz to about 100 Hz will be located on the skin of a patient adjacent a thoracic vertebrae in the vicinity of the transverse process of the vertebrae. Treatment will be at a force of less than about 5 lbs, more preferably less than about 4 pounds and most preferably less than about 2.5 lbs (about 22 N, about 18 N and about 11 N, respectively). The average Z-axis acceleration will be about 2.2 g, but can range from about 1.7 g to about 5 g, including 3.65g. The treatment time will be at least about 5 minutes, more preferably 10 minutes, and can be as long as 1 The treatment time will be at least about 2 minutes, more preferably 5 minutes, and can be as long as 10 minutes. Treatment may involve one session, two sessions or multiple sessions. The results will show at least one of reduced pain, reduced disability, increased mobility and increased alignment. X-ray images or other images suitable for demonstrating spinal alignment will be used to determine whether or not the treatment results in increased spinal alignment.

Example 3:

Treatment of Human Cervical Vertebrae

X-ray images or other images suitable for showing spinal alignment will be viewed prior to treatment. If images are not available, imaging will be conducted. A device having a stylus and a driver to generate a sinewave of about 5 Hz to about 200 Hz, more preferably about 8 Hz to about 150 Hz, still more preferably about 25 Hz to about 100 Hz and most preferably about 50 Hz to about 100 Hz will be located on the skin of a patient adjacent a cervical vertebrae in the vicinity of the transverse process of the selected vertebrae - it need not be C1. Treatment will be at a force of less than about 5 lbs, more preferably less than about 4 pounds and most preferably less than about 2.5 lbs (about 22 N, about 18 N and about 11 N, respectively). The average Z-axis acceleration will be about 2.2 g, but can range from about 1.7 g to about 5 g, including 3.65g.The treatment time will be at least about 2 minutes, more preferably 5 minutes, and can be as long as 10 minutes. Treatment may involve one session, two sessions or multiple sessions. The results will show at least one of reduced pain, reduced disability, increased mobility and increased alignment. X-ray images or other images suitable for demonstrating spinal alignment will be used to determine whether or not the treatment results in increased spinal alignment.

Example 4:

Treatment of Large Animal Lumbar Vertebrae

Large animals, for example, but not limited to, horses and cattle can be treated using the method of the present technology. X-ray images or other images suitable for showing spinal alignment will be viewed prior to treatment. If images are not available, imaging will be conducted. A device having a stylus and a driver to generate a sinewave of about 5 Hz to about 200 Hz, more preferably about 8 Hz to about 150 Hz, still more preferably about 25 Hz to about 100 Hz and most preferably about 50 Hz to about 100 Hz will be located on the hide of a patient adjacent a lumbar vertebrae in the vicinity of the transverse process of the vertebrae. Treatment will be at a force of less than about 9 pounds, preferably less than about 7 lbs, and most preferably less than about 5 lbs (about 40 N, about 31 N and about 22 N, respectively). The average Z-axis acceleration will be about 2.2 g, but can range from about 1.7 g to about 5 g, including 3.65g. The treatment time will be at least about 5 minutes, more preferably 10 minutes, and can be as long as 1 hou The treatment time will be at least about 2 minutes, more preferably 5 minutes, and can be as long as 10 minutes. Treatment may involve one session, two sessions or multiple sessions. The results will show at least one of reduced pain, reduced disability, increased mobility and increased alignment. X-ray images or other images suitable for demonstrating spinal alignment will be used to determine whether or not the treatment results in increased spinal alignment.

Example 5:

Treatment of Large Animal Thoracic Vertebrae

Large animals, for example, but not limited to, horses and cattle can be treated using the method of the present technology. X-ray images or other images suitable for showing spinal alignment will be viewed prior to treatment. If images are not available, imaging will be conducted. A device having a stylus and a driver to generate a sinewave of about 5 Hz to about 200 Hz, more preferably about 8 Hz to about 150 Hz, still more preferably about 25 Hz to about 100 Hz and most preferably about 50 Hz to about 100 Hz will be located on the hide of a patient adjacent a thoracic vertebrae in the vicinity of the transverse process of the vertebrae. Treatment will be at a force of less than about 9 pounds, preferably less than about 7 lbs, and most preferably less than about 5 lbs (about 40 N, about 31 N and about 22 N, respectively). The average Z-axis acceleration will be about 2.2 g, but can range from about 1.7 g to about 5 g, including 3.65g. The treatment time will be at least about 2 minutes, more preferably 5 minutes, and can be as long as 10 minutes. Treatment may involve one session, two sessions or multiple sessions. The results will show at least one of reduced pain, reduced disability, increased mobility and increased alignment. X-ray images or other images suitable for demonstrating spinal alignment will be used to determine whether or not the treatment results in increased spinal alignment.

Example 6:

Treatment of Large Animal Cervical Vertebrae

Large animals, for example, but not limited to, horses and cattle can be treated using the method of the present technology. X-ray images or other images suitable for showing spinal alignment will be viewed prior to treatment. If images are not available, imaging will be conducted. A device having a stylus and a driver to generate a sinewave of about 5 Hz to about 200 Hz, more preferably about 8 Hz to about 150 Hz, still more preferably about 25 Hz to about 100 Hz and most preferably about 50 Hz to about 100 Hz will be located on the hide of a patient adjacent a cervical vertebrae in the vicinity of the transverse process of the selected vertebrae - it need not be C1.Treatment will be at a force of less than about 9 pounds, preferably less than about 7 lbs, and most preferably less than about 5 lbs (about 40 N, about 31 N and about 22 N, respectively). The average Z-axis acceleration will be about 2.2 g, but can range from about 1.7 g to about 5 g, including 3.65g. Treatment may involve one session, two sessions or multiple sessions. The results will show at least one of reduced pain, reduced disability, increased mobility and increased alignment. X-ray images or other images suitable for demonstrating spinal alignment will be used to determine whether or not the treatment results in increased spinal alignment.

Example 7:

Treatment of Small Animal Lumbar Vertebrae

Small animals, for example, but not limited to, dogs and cats, can be treated using the method of the present technology. X-ray images or other images suitable for showing spinal alignment will be viewed prior to treatment. If images are not available, imaging will be conducted. A device having a stylus and a driver to generate a sinewave of about 5 Hz to about 200 Hz, more preferably about 8 Hz to about 150 Hz, still more preferably about 25 Hz to about 100 Hz and most preferably about 50 Hz to about 100 Hz will be located on the skin of a patient adjacent a lumbar vertebrae in the vicinity of the transverse process of the vertebrae. Treatment will be at a force of less than about 5 lbs, more preferably less than about 4 pounds and most preferably less than about 2.5 lbs (about 22 N, about 18 N and about 11 N, respectively). The average Z-axis acceleration will be about 2.2 g, but can range from about 1.7 g to about 5 g, including 3.65g. The treatment time will be at least about 2 minutes, more preferably 5 minutes, and can be as long as 10 minutes. Treatment may involve one session, two sessions or multiple sessions. The results will show at least one of reduced pain, reduced disability, increased mobility and increased alignment. X-ray images or other images suitable for demonstrating spinal alignment will be used to determine whether or not the treatment results in increased spinal alignment.

Example 8:

Treatment of Small Animal Thoracic Vertebrae

Small animals, for example, but not limited to, dogs and cats, can be treated using the method of the present technology. X-ray images or other images suitable for showing spinal alignment will be viewed prior to treatment. If images are not available, imaging will be conducted. A device having a stylus and a driver to generate a sinewave of about 5 Hz to about 200 Hz, more preferably about 8 Hz to about 150 Hz, still more preferably about 25 Hz to about 100 Hz and most preferably about 50 Hz to about 100 Hz will be located on the skin of a patient adjacent a thoracic vertebrae in the vicinity of the transverse process of the vertebrae. Treatment will be at a force of less than about 5 lbs, more preferably less than about 4 pounds and most preferably less than about 2.5 lbs (about 22 N, about 18 N and about 11 N, respectively). The average Z-axis acceleration will be about 2.2 g, but can range from about 1.7 g to about 5 g, including 3.65g. The treatment time will be at least about 2 minutes, more preferably 5 minutes, and can be as long as 10 minutes. Treatment may involve one session, two sessions or multiple sessions. The results will show at least one of reduced pain, reduced disability, increased mobility and increased alignment. X-ray images or other images suitable for demonstrating spinal alignment will be used to determine whether or not the treatment results in increased spinal alignment.

Example 9:

Treatment of Small Animal Cervical Vertebrae

Small animals, for example, but not limited to, dogs and cats, can be treated using the method of the present technology. X-ray images or other images suitable for showing spinal alignment will be viewed prior to treatment. If images are not available, imaging will be conducted. A device having a stylus and a driver to generate a sinewave of about 5 Hz to about 200 Hz, more preferably about 8 Hz to about 150 Hz, still more preferably about 25 Hz to about 100 Hz and most preferably about 50 Hz to about 100 Hz will be located on the skin of a patient adjacent a cervical vertebrae in the vicinity of the transverse process of the selected vertebrae - it need not be C1. Treatment will be at a force of less than about 5 lbs, more preferably less than about 4 pounds and most preferably less than about 2.5 lbs (about 22 N, about 18 N and about 11 N, respectively). The average Z-axis acceleration will be about 2.2 g, but can range from about 1.7 g to about 5 g, including 3.65g. The treatment time will be at least about 2 minutes, more preferably 5 minutes, and can be as long as 10 minutes. Treatment may involve one session, two sessions or multiple sessions. The results will show at least one of reduced pain, reduced disability, increased mobility and increased alignment. X-ray images or other images suitable for demonstrating spinal alignment will be used to determine whether or not the treatment results in increased spinal alignment.

Example 10:

Axial vibration was applied by placing individual discs into a chamber filled with cell culture medium. The lid on the chamber was fixed with a spring (k = 26.2 N/cm) that applied static axial load (Mean 40.6 N) on the disks during the unconstrained vibration. The chamber had an ±1.7g accelerometer fixed to it to track the vibration load when the chamber was mounted to a voice coil. The accelerometer was previously calibrated. The vibration of the voice coil was controlled with the output of a Linear Current Amplifier Module which received its command signal from a function generator. The voice coil and chamber were secured with damping to a shelf in a 37° C and 5% CO2 environmental control chamber. The control signal to the voice coil and the accelerometer output was monitored in real-time via an oscilloscope during the loading. Vibration was applied at various frequencies (0, 8, 16, 20, 30, 40, 50, 60, 70, 80, 160, 200 Hz) and amplitudes (0-0.54 g RMS) for either 10 or 60 minutes. The order of both amplitude and frequency selection was randomly assigned to eliminate any time-dependent trends due to sample storage. All conditions were run on a minimum of 5 separate discs (from at least two different bovine tails).

The results indicated that frequency significantly affected expression of collagen type II, decorin, and versican mRNA. The regression slopes for each of these genes were not significant. Amplitude significantly affected expression of biglycan, collagen type I, collagen type II, decorin, and versican mRNA. The regression slopes for these genes were significant and positive for all of these genes, with the exception of versican, which was not significant. In general, the results indicated a positive effect of axial vibration on extracellular matrix gene expression. Most genes were at or above control levels for most frequencies and amplitudes, with the notable exceptions of biglycan and versican. Both of these genes exhibit complex expression patterns with high and low regions throughout the amplitude spectrum. Regardless of frequency and amplitude, versican expression was reduced after 60 minutes of exposure. In general, it was concluded that the conditions that promoted nucleus pulposus gene expression were about 0.5g, about 16Hz for half the time with a sweep from about 50 to about 80Hz for half the time for 10minutes.

Example 11:

Vibration was applied by placing the stylus of the device disclosed in CA2005/000353 to Khan et al. onto the sensitive region of a 450 N load cell that was fixed over the area of the spinous process of the center vertebrae of the 5 segment bovine tail. Three dimensional ±10 g accelerometers were mounted on a cube and aligned with the axes of the disc (X-axial compression/tension, Y- shear 90 deg out of alignment with applied load, Z-shear parallel with applied load) and glued to the bone using cyanoacrylate to track acceleration of both the loaded and adjacent vertebral bodies. The accelerometers were previously calibrated using a 1 g shaker plate. The voice coil mounted and producing the vibration from within the device was controlled with the output of a Linear Current Amplifier Module which received its command signal from a function generator. The current going to the voice coil and the accelerometer output was monitored in real-time via an oscilloscope during the loading. Imparted mechanics vibration was tested at four different current values (~0.9-1.9 Amp driving current). The testing vibration was applied at two static frequencies (0 or 16 Hz) and/or one sweep frequency (50-80 Hz) that would step up the frequency by 2 Hz every two cycles of oscillation. Each frequency treatment was applied for 10 minutes and one treatment alternated combined frequencies of 16 and 50-80 Hz for 5 minutes each to maintain the overall 10 minute application. All amplitudes were sustained at 0.5-5 g peak root mean square [RMS] of the vertebrae directly receiving the load. This is similar to current clinical treatments using the device, and corresponds to those stimuli eliciting peak responses in previous experiments. The order of control samples versus actual vibration samples was randomly assigned to eliminate any time-dependent trends due to sample storage. All conditions were run on a minimum of 6 separate discs (from at least three different tails). Control discs were treated equally (stored, handled, dissected, and snap-frozen) in order to perform as true unloaded controls.

The results showed non-significant changes in expression of collagen type I and increased expression of aggrecan, collagen type II and versican. This suggests a potential beneficial effect of the current vibration loading pattern tested in the study. When compared to Example 10, it can be concluded that the placement of the stylus of the device on the vertebrae rather than providing unconstrained vibration to the vertebrae provides a further improvement in maintaining and potentially improving disc health through increased gene expression. On the basis of the results of this study and the clinical studies of spinal intervention, a suitable treatment for human patients was determined to be exposing at least one intervertebral disc to a repetitive sinewave impulse at a force of about 5.5 N to about 12.2 N, each sinewave impulse having an acceleration of about 0.5g to about 5 g, at 16 Hz followed by a sweep between about 50 to about 80Hz. The preferable treatment was at a force of 0.5 N with an acceleration of 0.5g. The method is preferably effected using the treatment device disclosed in CA2005/000353 to Khan et al.

Example 12:

Using saggital plane cervical x-rays, pre and post intervention MARs were calculated for 44 patients with chronic neck pain. The study used a randomized, single blinded, and sham controlled design for comparisons of outcome measures. The intervention input was assessed using a load cell and vertebral acceleration and the outcome measures were: 1. cervical MARs, 2. self-reported neck pain [11-point scale], 3. neck disability index scores, 4. psycho-social assessments for stress, anxiety, and depression.

The device used was a spinal and upper cervical treatment device consisting of a controller mounted on top of an impulse delivery mechanism, or device head, which is mounted on a movable armature to a fixed stand. The device head generates waveforms [sinewave at 50-110Hz] and the stylus located at the base of the device head mechanically transduces the waveforms through the skin and ultimately to the spine, causing minor vibration of the vertebrae and minor repetitive stretching/activation of the attached soft tissues. The stylus amplitude is controlled by a touch screen setting called the 'Intensity' which ranges from 0 to 1 and controls the amplitude of current that is supplied to the stylus actuator. Treatment is typically given at 0.5 and stylus imparted mechanics has been quantified using in situ bovine tail here in. Patients in both groups were required to undergo treatment, either actual or sham, two or three times per week for a period of four to six weeks with each treatment lasting about 10 minutes. The preferred treatment was an acceleration of about 0.5g to about 2.2 g, at a force of about 9 N to about 10.5 N and a frequency sweep from about 40 Hz to about 120 Hz for a period of about 30 seconds to about 5 minutes, with repeated individual treatments for 4 to 6 weeks. The more preferred treatment was an acceleration of about 0.5 g to about 1.5 g, at a force of about 9.5 N to about 10.4 N and a frequency sweep of about 45 Hz to about 115 Hz for a period of about 30 seconds to about 2 minutes. The most preferred treatment was an acceleration of about 0.5 g, at a force of 10.3 N, and a frequency sweep of about 50 to about 110 Hz for a period of 30sec to 2min, with repeated individual treatments for 4-6 weeks.

The treatment improved pain and neck disability scores significantly compared to sham controls, corrected 62 percent of abnormal MARs with significantly larger MAR vector magnitude differences [pre-post] at the C5-C6 level than shams, and in patients without changes in MAR locations, the treatment significantly improved neck disability scores above the sham group . MAR correction was significantly related to improving both pain and neck disability across all subjects. Hence the study provided biomechanical evidence of spinal 're-alignment' and its ability to improve both pain and neck disability.

Example 13:

Caliper measurements were used to determine alignment of the spine, by measuring the shoulder tilt and the hip tilt. As would be known to one skilled in the art, any means that allows a practitioner to assess tilt can be used, for example, but not limited to optical devices or a tape measure. A top skull x-ray image, a lateral x-ray image and a frontal x-ray image were taken to determine the location and orientation of the atlas. As would be known to one skilled in the art, any body imaging device that allows a practitioner to identify spinal vertebrae can be used, for example, but not limited to CT scans or MRI. On the basis of the location and orientation, the physician determined the vector for treatment. For example, if the atlas is tilted up the treatment vector will be down. The vector can be determined manually, but preferably is determined with a suitable processor, for example, but not limited to a computer. The stylus can be placed in the general vicinity of the altas. He then ensured that the stylus angle was correct and positioned the stylus into position on the patient's neck using the pen mark as a locator. The stylus is aligned along the treatment vector. The stylus caused a depression of approximately 2mm below the skin surface and was on a bony landmark of the transverse process of the atlas, however, the stylus need not be placed on a bony landmark of the transverse process - it can be placed in the general vicinity of the altas. Further, there may be more than one probe, for example two probes. The preferred device for the treatment is one that controls the location and angle of the stylus relative to the patient and provides a highly controlled impulse in the form of a sinusoidal wave. The preferred treatment was an acceleration of about 0.5g to about 2.2 g, at a force of about 9 N to about 10.5 N and a frequency sweep from about 40 Hz to about 120 Hz for a period of about 30 seconds to about 5 minutes, with repeated treatments weekly, or every two weeks, or every three weeks or every month for 4 to 6 weeks or 6 to 8 weeks, or more, as needed. The more preferred treatment was an acceleration of about 0.5 g to about 1.5 g, at a force of about 9.5 N to about 10.4 N and a frequency sweep of about 45 Hz to about 115 Hz for a period of about 30 seconds to about 2 minutes. The most preferred treatment was an acceleration of about 0.5 g, at a force of 10.3 N, and a frequency sweep of about 50 to about 110 Hz for a period of 30sec to 2min, with repeated individual treatments.

The results showed at least one of an improvement of spinal alignment, a reduction in shoulder and/or hip tilt, a reduction in pain, a reduction in swelling and an improvement in mental health.

The foregoing is a description of the technology. As would be known to one skilled in the art, variations are contemplated that do not alter the scope of the technology, for example, any device that is capable of delivering the above specified treatment conditions can be employed.

Industrial Applicability

Sequence List Text

Claims

An assembly for treating a patient, the assembly comprising: a body imaging device for creating images of a plurality of spinal vertebrae of the patient;

a processor for determining a treatment vector; a device for treating the patient, the device comprising a stylus, a controller and an actuator for driving the stylus in a linear direction, the device configured to: -allow for alignment of the stylus on the treatment vector and placement on a vertebrae of the patient;

-provide a repetitive sinewave impulse of having a force of about 5.5 N to about 12.2 Newtons (N) with a shear acceleration of about .5 g to about 5g at about 5 Hertz (Hz) to about175 Hertz.
The assembly of claim 1, further comprising a treatment table.
The assembly of claim 1 for spinal realignment, improving abnormal mean axes of rotation or improving disc health.
The assembly of claim 1, wherein the device is configured to provide a force of about 9 N to about 11 N.
The assembly of claim 4, wherein the device is configured to provide acceleration of about 2.2 g.
The assembly of claim 5, wherein the device is configured to provide a frequency of about 50 to about 110 Hz.
The assembly of claim 3, wherein the device is configured to provide a frequency sweep of about 50 to about 110 Hz with an acceleration of about 0.5 g.
A use of the assembly of claim 1 for the treatment of a patient in need thereof.
The use of claim 3 for the treatment of a patient in need thereof.
A use of an assembly for the treatment of a patient, the assembly comprising:

a body imaging device for creating images of a plurality of spinal vertebrae of the patient;

a processor for determining a treatment vector;

a device for treating the patient, the device comprising a stylus, a controller and an actuator for driving the stylus in a linear direction, the device configured to:

-allow for alignment of the stylus on the treatment vector and placement on a vertebrae of the patient;

-provide a repetitive sinewave impulse of having a force of about 8 N to about 12 N with a shear acceleration of at most about 2.2 g at about 50 Hertz (Hz) to about 110 Hertz.
The use of claim 10 for the treatment of abnormal mean axes of rotation, spinal misalignment or disc degeneration.
The use of claim 11 for the treatment of abnormal mean axes of rotation.
The use of claim 11 for the treatment of spinal misalignment.
The use of claim 11 for the treatment of disc degeneration.
A method of treating a patient in need thereof, the method comprising:

imaging a plurality of spinal vertebrae;

determining a treatment vector;

locating a spinal vertebrae;

aligning a stylus along the treatment vector and positioning it on a vertebrae of the patient; and providing a repetitive sinewave impulse of a force of about 5.5 N to about 12.2 N with a shear acceleration of at most about 5 g at about 50 Hertz (Hz) to about 175 Hertz to the vertebrae.
The method of claim 15 wherein the vertebrae is the atlas and the plurality of spinal vertebrae are cervical vertebrae.
The method of claim 16 wherein the acceleration is about .5 g.
The method of claim 17 wherein the frequency is a sweep of about 50 to about 110 Hz.
The method of claim 18 wherein the force is about 10.3 N.
The method of claim 19 wherein the treatment is between about 2 minutes to about 5 minutes.
The method of claim 19 further comprising determining a mean axes of rotation of the cervical vertebrae.
The method of claim 20 for the treatment of abnormal mean axes of rotation.
A method of promoting disc health, the method comprising exposing at least one intervertebral disc to a repetitive sinewave impulse at a force of about 5.5 N to about 12.2 N, each sinewave impulse having an acceleration of about 0.5g to about 5g at 16 Hz followed by a sweep between about 50 to about 80Hz.
The method of claim 23 wherein the force is 10.3, and the acceleration is .5g.
A method of delivering a stylus of a medical treatment assembly to a treatment location on a vertebrae of a patient, said medical assembly comprising:

a body imaging device;

a processor; and

a medical treatment device for treating the patient, said medical treatment device comprising the stylus, a controller and an actuator for driving said stylus in a linear direction, the medical treatment device configured to:

-allow for alignment of the stylus on the treatment vector and placement on a vertebrae of the patient;

-provide a repetitive sine wave impulse of having a force of about 11 N to about 22 N with a

shear acceleration of about 1.7 g to about 5g at about 5 Hertz (Hz) to about 200 Hertz;

the method comprising the steps of:

creating images of a plurality of spinal vertebrae of said patient;

determining a treatment vector; deploying the medical treatment assembly proximate to the patient;

placing the medical treatment device proximate to the spinal vertebrae of the patient;

aligning the stylus on said treatment vector; and

placing the aligned stylus on the spinal vertebrae of the patient.