WO2006031844A2 - Traitement de la cause des douleurs dorsales par traction dans une chambre hyperbare - Google Patents

Traitement de la cause des douleurs dorsales par traction dans une chambre hyperbare Download PDF

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WO2006031844A2
WO2006031844A2 PCT/US2005/032632 US2005032632W WO2006031844A2 WO 2006031844 A2 WO2006031844 A2 WO 2006031844A2 US 2005032632 W US2005032632 W US 2005032632W WO 2006031844 A2 WO2006031844 A2 WO 2006031844A2
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group
patient
traction
nutritional supplement
disc
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WO2006031844A3 (fr
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Jeffrey E. Yeung
Teresa T. Yeung
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Yeung Jeffrey E
Yeung Teresa T
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H1/00—Apparatus for passive exercising; Vibrating apparatus; Chiropractic devices, e.g. body impacting devices, external devices for briefly extending or aligning unbroken bones
    • A61H1/02—Stretching or bending or torsioning apparatus for exercising
    • A61H1/0218—Drawing-out devices
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/15—Vitamins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17—Amino acids, peptides or proteins
    • A23L33/175—Amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61G—TRANSPORT, PERSONAL CONVEYANCES, OR ACCOMMODATION SPECIALLY ADAPTED FOR PATIENTS OR DISABLED PERSONS; OPERATING TABLES OR CHAIRS; CHAIRS FOR DENTISTRY; FUNERAL DEVICES
    • A61G10/00—Treatment rooms or enclosures for medical purposes
    • A61G10/02—Treatment rooms or enclosures for medical purposes with artificial climate; with means to maintain a desired pressure, e.g. for germ-free rooms
    • A61G10/023—Rooms for the treatment of patients at over- or under-pressure or at a variable pressure
    • A61G10/026—Rooms for the treatment of patients at over- or under-pressure or at a variable pressure for hyperbaric oxygen therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H1/00—Apparatus for passive exercising; Vibrating apparatus; Chiropractic devices, e.g. body impacting devices, external devices for briefly extending or aligning unbroken bones
    • A61H1/02—Stretching or bending or torsioning apparatus for exercising
    • A61H1/0218—Drawing-out devices
    • A61H1/0222—Traction tables
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/16—Physical interface with patient
    • A61H2201/1602—Physical interface with patient kind of interface, e.g. head rest, knee support or lumbar support
    • A61H2201/1619—Thorax
    • A61H2201/1621—Holding means therefor

Definitions

  • This invention relates to methods and devices to increase uptake of nutrients and oxygen into the intervertebral disc using traction, oxygen, a hyperbaric chamber, nutritional supplements and/or vasodilators to enhance biosynthesis of sulfated glycosaminoglycans and restore swelling pressure within the intervertebral disc.
  • the intervertebral disc is thought to play a central role. Degeneration of the disc initiates pain in other tissues by altering spinal mechanics and producing stress in surrounding tissues.
  • Intervertebral discs 100 absorb most of the compressive load of the spine, with the facet joints 129 sharing approximately 16% of the load, as depicted in Figure 1.
  • the disc 100 consists of three distinct parts: the nucleus pulposus 128, the annular layers 316 and the cartilaginous endplates 105, as shown in Figures 1 and 2.
  • the disc 100 maintains its structural properties largely through its ability to attract and retain water.
  • a normal disc 100 contains 80% water.
  • the nucleus pulposus 128 is particularly rich in water absorbing sulfated glycosaminoglycans, which create the swelling pressure to provide tensile stress within the collagen fibers of the annulus 316.
  • the swelling pressure produced by high water content is crucial to support the annular layers 316 and sustain compressive loads.
  • the intervertebral disc 100 is avascular. Water, nutrients and oxygen 317 are transported from external blood vessels through endplate flow 326 and annular flow 325, as shown in Figure 3. Survival of the disc cells, as well as production of chondroitin and keratan sulfates, depend on endplate flow 326 and annular flow 325. However, annular flow 325 penetrates only up to 1 cm into the annular layers of the disc 100. An adult disc can be as large as 5 cm in diameter; hence endplate flows 326 through both the cranial and caudal endplates 105 are crucial for maintaining the health of the nucleus pulposus 128 and inner annular layers 316 of the disc 100. Water gain and loss depend on the disc pressure.
  • chondroitin and keratan sulfates creates the swelling pressure that provides tensile stress within the collagen fibers of the annulus 316, as shown in Figure 5.
  • Chondroitin sulfate is the primary, and keratan sulfate the secondary, water absorbing sulfated glycosaminoglycans within the intervertebral disc, as shown in Figure 29, crucial for maintaining swelling pressure to support the annular layers 316 and sustain compressive loads.
  • Calcified layers 108 begin to accumulate in the cartilaginous endplate 105 as early as 18 years of age, as shown in Figure 6 (Oda J, Tanaka H, Tsuzuki N: Intervertebral disc changes with aging of human cervical vertebra from the neonate to the eighties, Spine, 13(11), 1205-1211, 1988).
  • the blood vessels and capillaries at the bone- cartilage interface are gradually occluded by the build-up of the calcified layers 108, which form into bone (Bernick S, Cailliet R: Vertebral endplate changes with aging of human vertebrae, Spine, 7(2) 97-102, 1982). Bone formation at the endplate 105 increases with age, restricting diffusion of nutrients 317, including sulfate, proline and oxygen, from entering into the nucleus pulposus 128.
  • the nucleus pulposus 128 is thought to function as "air in a tire” to pressurize the disc 100.
  • Normal swelling pressure effectively distributes the forces evenly along the circumference of the inner annulus 316 and keeps the lamellae bulging outward. With lack of swelling pressure, the degenerated disc 100 exhibits unstable movement, similar to a flat tire, as depicted in Figure 8.
  • Figure 9 Weiler PJ, King GJ, Gertzbein SD: Analysis of sagittal plane instability of the lumbar spine, Spine, 15:1300-1306, 1990).
  • the pain may originate from increased load and stress on the facet joints 129 and/or surrounding ligaments (Kirkaldy- Willis WH, Farfan HF: Instability of the lumbar spine, Clin Orthop, 165:110-123, 1982).
  • Shear stresses of the disc 100 are highest at the posterolateral portions adjacent to the neuroforamen. With decreased swelling pressure, shear stresses cause the delamination 114, tearing and bulging of the annulus 316, as depicted in Figure 10.
  • the nerve 194 is confined within the neuroforamen 121 between the disc 100 and the facet joint, vulnerable to impingement 329 by the bulging disc 100, as shown in Figure 11.
  • chondroitin and keratan sulfates are crucial to retaining water for the swelling pressure to sustain compressive loads and maintain disc height.
  • the disc 100 is expandable or inflatable in the absence of compressive loads.
  • a majority of astronauts suffer constant back pain in space, but not from instability or impingement. Their discs expand or thicken significantly, elongating the spine, the spinal cord, facet joint capsules, anterior and posterior longitudinal ligaments- The heights of astronauts increase between 4-7 cm in space (Hutchinson KJ, Watenpaugh DE, Murthy G, Convertino VA, Hargens AR: Back pain during 6 degree head-down tilt approximates that during actual micro gravity, Aviat Space Environ Med, Mar; 66(3):256-9, 1995).
  • the daily cycle of disc compression during the day and recovery during the night is missing. Water continues to accumulate beyond the normal recovered volume, leading to disc thickening.
  • Micro-gravity would be an ideal treatment for spinal instability or spinal stenosis. Unfortunately, the excess water within the discs is eliminated within days or weeks after the compressive loads resume. Spine lengthening is also observed when placing a person on a 6 degree head-down tilt bed.
  • endplate flow 326 is also significantly restricted by the calcified layer 108, and oxygen penetration from annular flow 325 is shallow.
  • oxygen partial pressure in the disc falls below 0.25 kPa
  • anaerobic production of lactic acid dramatically increases with increasing distance from the endplate.
  • the pH within the disc falls as lactic acid concentration increases. Lactic acid diffuses through micro-tears of the annulus and irritates the richly innervated posterior longitudinal ligament, facet joint and/or nerve root.
  • Studies indicate that lumbar pain correlates well with high lactate levels and low pH (Diamant B, Karlsson J, Nachemson A: Correlation between lactate levels and pH of patients with lumbar rizopathies, Experientia, 24, 1195-1196, 1968).
  • the mean pH of 23 symptomatic discs is significantly lower than the mean pH of normal discs (6.65 ⁇ 0.07 versus 7.14 ⁇ 0.04, pO.OOOl, respectively). Acid concentration is three times higher in symptomatic discs than normal discs. In symptomatic discs with pH 6.65, the acid concentration within the disc is about 5.6 times the plasma level. In some preoperative symptomatic discs, nerve roots were found to be surrounded by dense fibrous scars and adhesions with remarkably low pH 5.7- 6.30 (Nachemson A: Intradiscal measurements of pH in patients with lumbar rhizopathies, Acta Orthop Scand, 40, 23-43, 1969). The acid concentration within the disc was about 50 times the plasma level.
  • non-specific pain The majority of patients with low back pain cannot be given a precise pathoanatomical diagnosis. This type of pain is generally classified under "non-specific pain". Back pain and sciatica can be recapitulated by maneuvers that do not affect the nerve foot, such as intradiscal saline injection, discography, and compression of the posterior longitudinal ligaments. It is possible that some of the non-specific pain is caused by lactic acid irritation secreted from the disc. Injection into the disc can flush out the lactic acid. Maneuvering and compression can also drive out the irritating acid to produce non-specific pain. Currently, no intervention other than the discectomy can stop the production of lactic acid.
  • the rate of sulfate uptake into the disc 100 is pH sensitive.
  • the maximum rate of sulfate incorporation occurs at pH 7.2-6.9. Below pH 6.8, the rate falls steeply.
  • the sulfate incorporation rate is only around 32-40% of the rate at pH 7.2-6.9.
  • calcified endplates initiate a progression of degenerating factors upon the intervertebral disc 100.
  • Sulfate deficiency reduces chondroitin sulfate and keratan sulfate concentration within the disc.
  • B Production of the highly water-absorbing chondroitin sulfate is further hindered under anaerobic condition.
  • C Water loss from reduction of sulfated glycosaminoglycans lowers the swelling pressure within the nucleus pulposus, leading to inward bulging and delamination of the annulus, added load on facet joints, strain from segmental instability and nerve impingement from disc space narrowing or bulging.
  • D Lactic acid production in anaerobic condition irritates nerves, causes pain and further slows down the rate of sulfate uptake into the disc, which leads to progressive disc degeneration and pain.
  • Air consists of approximately 80% nitrogen and 20% oxygen.
  • PSI pounds per square inch
  • nitrogen partial pressure - 0.8 and oxygen partial pressure 0.2.
  • nitrogen partial pressure becomes 0.4 and nitrogen partial pressure becomes 1.6.
  • 100% oxygen is used under 2 ATA in the hyperbaric chamber, the oxygen partial pressure becomes 2.0.
  • the blood pressure measured within the hyperbaric pressure remains approximately the same, the absolute pressure within the patient's bodily circulation is approximately equal to the pressure within the hyperbaric chamber plus the blood pressure of the patient.
  • the disc is avascular. Diffusion of nutrients and oxygen through the endplates is crucial for survival of the cells within the disc. As the endplates become calcified, diffusion of nutrients and oxygen diminishes, leading to the loss of swelling pressure and capacity to sustain compressive loads.
  • a hyperbaric chamber is used to increase oxygen partial pressure to enhance diffusion and convective flows of oxygen into the deprived disc.
  • traction is used within the hyperbaric chamber to lower the disc pressure, favoring and promoting oxygen uptake into the avascular disc. Building blocks of the sulfated glycosaminoglycans are ingested as nutritional supplements to increase concentration for diffusion into the disc.
  • vasodilators can also be used to increase blood flow, bringing nutrients and oxygen near the avascular disc to enhance uptake.
  • biosynthesis of sulfated glycosaminoglycans increases to restore swelling pressure, sustain compressive loads and alleviate back pain.
  • FIG. 1 shows a vertebral segment with an intervertebral disc 100 and facet joint 129 sharing the compressive load between vertebral bodies 159.
  • Figure 2 shows a healthy and well-hydrated disc 100 containing nucleus pulposus 128 and annulus 316.
  • the nerve root 194 extends from the neuroforamen 121.
  • Figure 3 depicts diffusion of nutrients and oxygen 317 through endplate flows 326 and annular flows 325 into the avascular intervertebral disc 100.
  • Figure 4 depicts convective flows of nutrients and oxygen 317 into a relaxed disc 100 in the supine position.
  • Figure 5 depicts swelling pressure within the nucleus pulposus 128 providing tensile stress within the collagen fibers of the annulus 316 for sustaining compressive loads and stability.
  • Figure 6 depicts formation of calcified layers 108 over endplates 105, restricting endplate flow 326 of nutrients and oxygen 317 into the avascular disc 100.
  • Figure 7 depicts decreased glycosaminoglycans and swelling pressure within the disc 100, applying inadequate tensile stress to the annulus 316 and resulting in inward annular bulging and delamination 114.
  • Figure 8 depicts unstable movement of the vertebral segment caused by inadequate swelling pressure within the degenerated disc 100.
  • Figure 9 depicts segmental instability and stress on the facet joint 129.
  • Figure 10 depicts annular 316 rupture and bulging of a degenerated disc 100.
  • Figure 11 shows annular delamination 114, disc 100 bulging and nerve 194 impingement 329.
  • Figure 12 shows a patient in the supine position to lower disc pressure within a hyperbaric chamber 318.
  • Figure 13 depicts increased partial pressure of oxygen 317 within the disc 100 through endplate flow 326 and annular flow 325, resulting from increased partial pressure within the hyperbaric chamber 318.
  • Figure 14 shows a patient undergoing traction within the hyperbaric chamber 318.
  • Figure 15 shows a patient undergoing traction using a head-tilt traction bed 320.
  • Figure 16 depicts disc volume increase by traction to lower the disc pressure. Added pressure from the hyperbaric chamber intensifies the endplate flow 326 and annular flow 325 into the disc 100.
  • Figure 17 depicts increased swelling pressure within the disc 100 from newly produced glycosaminogly ⁇ ans made with the replenished supply of nutrients and oxygen 317.
  • Figure 18 shows increased swelling pressure pushing the annulus 316 outward to support compressive loads on the disc 100.
  • Figure 19 shows traction to increase the height of a bulging disc 100 with weakened annular layers 316.
  • Figure 20 shows intensified annular convective flow 325 generated by the hyperbaric chamber 318 and traction causing the weakened annular 316 to bulge inward.
  • Figure 21 shows trapping of the outer annulus 316 in the inward bulging position after releasing the traction while maintaining pressure within the hyperbaric chamber.
  • Figure 22 shows nerve root 194 impingement 329 by bone spurs 328 and spinal stenosis.
  • Figure 23 depicts enhancement of convective flow 325 and endplate flow of nutrients and oxygen 317 using traction and a hyperbaric chamber to enhance biosynthesis of glycosaminoglycans and swelling pressure.
  • Figure 24 shows a patient with a head harness 321, upper body holder 285 and lower body holder 286 within the hyperbaric chamber 318.
  • Figure 25 shows a patient with head harness 321 on a head-tilt traction bed 320 for treating cervical, thoracic and lumbar discs.
  • Figure 26 depicts nutrients and oxygen 317 flow through an annular conduit 126 to nourish the disc cells under traction and/or hyperbaric pressure.
  • Figure 27 depicts nutrients and oxygen 317 flow through an inferior endplate conduit 126 to nourish the disc cells under traction and/or hyperbaric pressure.
  • Figure 28 depicts nutrients and oxygen 317 flow through a superior endplate conduit 126 to nourish the disc cells under traction and/or hyperbaric pressure.
  • Figure 29 shows molecular structures of repeating disaccharides in chondroitin sulfate and keratan sulfate.
  • Figure 30 depicts the structural arrangement of proteoglycans containing a hyaluronic acid as backbone, link protein and core protein linked to multiple chondroitin and keratan sulfates.
  • Figure 31 shows the molecular structure of repeating disaccharides in hyaluronic acid.
  • Figure 32 shows possible linkages of chondroitin sulfate and keratan sulfate to protein/collagen and hyaluronic acid.
  • Figure 33 shows a patient on a traction bed 320 within a hyperbaric chamber 318, partially submerged in a solution 330 and strapped with ultrasound transducers 331.
  • Nutrient and oxygen deficiency is generally accepted as a major cause of disc degeneration. As calcified layers 108 form over the endplates 105, diffusion of nutrients and oxygen diminishes. When external oxygen partial pressure increases, the oxygen partial pressure within bodily circulation will also increase to supply the oxygen-deprived disc 100. Pure oxygen is commonly used in a hyperbaric chambers 318 at 2 ATA.
  • the present invention depicted in Figure 12, shows a back pain patient lying flat in a hyperbaric chamber 318 using a leg support 319 to minimize disc pressure for maximum oxygen uptake. Since diffusion flows from high to low concentration, increased oxygen partial pressure will intensify endplate flow 326 and annular flow 325 into the disc 100 as shown in Figure 13. If 100% oxygen is used at 2 ATA in the hyperbaric chamber 318, the oxygen partial pressure will become 2.0, ten times higher than the oxygen partial pressure in ambient air at 1 ATA.
  • the disc 100 contains mostly incompressible water, a small disc volume change will provide a huge pressure difference within the disc 100.
  • the spine is in the supine position with minimal compressive loads.
  • surrounding muscles are relaxed, allowing the disc 100 to expand in volume.
  • disc pressure drops significant.
  • water flows inward through convection (from high to low pressure).
  • Chondroitin and keratan sulfates within the disc 100 provide water absorbing and retaining capabilities to pressurize the disc 100 during sleep. In essence, creating a small volume increase leads to a large disc pressure drop, promoting a convective uptake of fluid into the disc 100.
  • Figure 14 shows a patient on a traction bed 320 within the hyperbaric chamber 318 being pulled by an upper holder 285 toward one direction 289 and by a lower holder 286 toward the opposite direction 290.
  • the traction bed 320 can also be a head-down tilt bed 320 within the hyperbaric chamber 318, as shown in Figure 15. Traction is used to create a small disc volume increase. However, the elevated pressure within the hyperbaric chamber 318 also compresses or collapses the disc 100, which was under atmospheric pressure (1 ATA).
  • the hyperbaric compressive force upon the disc 100 can be estimated by multiplying the surface area of the disc 100 by the hyperbaric pressure in addition to 1 ATA or 14,7 PSI.
  • the total surface area of the lumbar disc 100 is about 5.3 inch 2 .
  • hyperbaric pressures in addition to 14.7 PSI are listed as examples in Table 1.
  • the hyperbaric compressive force in pounds upon the disc 100 is estimated Using 5.3 inch multiplied by the hyperbaric pressure in PSI, shown in Table 1.
  • Table 1 Hyperbaric Compressive Force on Disc and Oxygen Partial Pressure
  • Table 1 shows significant increase in oxygen partial pressure within the hyperbaric chamber, especially using 100% oxygen.
  • the high oxygen partial pressure in bodily circulation favors uptake of oxygen into the oxygen-deprived disc 100 through diffusion.
  • disc volume increases while the disc pressure drastically decreases.
  • the combination of traction and hyperbaric pressure can also be useful to treat disc bulging.
  • Shear stresses can cause delamination, weakening and tearing of the annulus 316, which leads to disc bulging.
  • the bulging annulus 316 is weak and often floppy.
  • bulging near the neuroforamen can impinge upon the nerve root 194, as shown in Figure 11. Traction is used to widen the disc space, as shown in Figure 19.
  • the floppy or bulging annulus 316 is more sensitive to hyperbaric pressure increase than the healthy annulus.
  • the widened disc space provides entry for the bulging annulus 316.
  • the distracted or widened disc space creates disc pressure drop.
  • the bulging annulus 316 is pressed inward into the low- pressure nucleus pulposus 128. While maintaining the pressure or annular flow 325, traction is released to restore normal disc height and trap the annulus 316 in the inward bulging position, as shown in Figure 21. As a result, nerve impingement by the outward bulging annulus 316 is minimized.
  • the time between traction, hyperbaric pressure and release of traction is preferred to be short to avoid pressure build up within the disc 100. In conjunction with traction, lateral bending away from the bulge may provide additional space for inward movement of the bulging annulus 316.
  • Calcified endplates 105 are also common in cervical segments.
  • Figure 24 shows a patient using multiple tractions simultaneously.
  • a head harness 321 pulled by a tensile machine 322, an upper body holder 285 and lower body holder 286 are used within the hyperbaric chamber 318.
  • Figure 25 shows a patient on a head-down tilt traction bed 320 using a head harness 321 to apply traction from the neck with foot holders 324 to anchor the lower part of the body.
  • cervical, thoracic and lumbar discs 100 obtain fluid uptake with high oxygen partial pressure from the combined traction and hyperbaric treatment.
  • Conduits 126 were proposed by J. Yeung and T. Yeung, PCT/US2004/14368 on May 7, 2004 and J. Yeung, PCT/US2005/22749 on June 22, 2005 to re-establish the exchange of nutrients and waste between the avascular disc 100 and bodily circulation.
  • hyperbaric chamber 318 and/or traction bed 320 can be used to enhance transport of nutrients and oxygen 317 into the disc 100.
  • the hyperbaric chamber 318 intensifies pressure to drive convective flows.
  • the hyperbaric chamber 318 can be pressurized with 100% oxygen to increase oxygen partial pressure through the conduit 126 to saturate the oxygen-deprived disc 100.
  • Traction is used to lower disc pressure to favor convective flows into the degenerative disc 100.
  • a combination of hyperbaric pressure and traction further intensifies uptake of nutrients and oxygen 317 through the conduits 126.
  • Figure 26 shows flow of nutrients and oxygen 317 through the annular conduit 126 enhanced by the hyperbaric chamber 318 and/or traction to nourish the cells within the deprived disc 100.
  • the hyperbaric chamber 318 or traction can be used to enhance flow of nutrients and oxygen 317 through endplate conduits 126, as shown in Figures 27 and 28.
  • Chondroitin sulfate and keratan sulfate contain repeating disaccharides with molecular structures shown in Figure 29.
  • the repeating disaccharides of chondroitin sulfate are D- glucuronic acid and N-acetyl- ⁇ -sulfate-D-galactosamine.
  • the repeating disaccharides of keratan sulfate are D-galactose and N-acetyl-6-sulfate-D-glucosamine.
  • chondroitin and keratan sulfates commonly attach to a core protein and a link protein bonding to a long chain hyaluronic acid to form proteoglycans, as depicted in Figure 30.
  • Hyaluronic acid also contains repeating disaccharides, glucuronic acid and N- acetyl-D-glucosamine, as shown in Figure 31.
  • the connections between chondroitin and keratan to core proteins contain a terminal unit linking to serine or threonine of the core protein, as shown in Figure 32, to form proteoglycans.
  • the nucleus pulposus 128 is rich in proteoglycans essential for retaining water within the disc 100.
  • chondroitin and keratan sulfates with a terminal unit can also link to hydroxylysine of collagen, as shown in Figure 32, a major component of the annulus 316.
  • the terminal unit of the chondroitin or keratan sulfate can contain ⁇ -glucuronic acid (1-3) - ⁇ -galactose (1-3) - ⁇ -galactose (1-4) - ⁇ - xylose to link with the core protein.
  • the hydroxyl-group, -OH, of serine, threonine or hydroxylysine from protein or collagen is the likely functional group linking to the carbohydrate of the terminal unit, ⁇ -xylose of the terminal unit is possibly the linkage connecting to the serine or threonine of the core protein, or connecting to hydroxylysine of collagen. Bonding between the carbohydrate and protein/collagen to form proteoglycan is essential for retaining water and building tensile strength of the intervertebral disc 100.
  • Silicon is also present with approximately one atom of silicon per 130-280 repeating units of the polysaccharides in cartilage and chondroitin sulfate. Silicon is a biological crosslink agent that forms side chains of polysaccharides or proteoglycans.
  • the crosslinked matrix provides additional strength and resiliency in connective tissue, such as the cartilaginous endplate 105, annulus 316, nucleus pulpous 128 and/or hyaline cartilage in joints.
  • the crosslinked matrix of proteoglycans or polysaccharides contains negative charges to absorb and retain a significant amount of water essential for the nucleus pulposus 128 and the intervertebral disc 100.
  • the silicon crosslink agent can be orthosilicic acid, Si(OH) 4 , reacting with hydroxyl groups of the carbohydrates to form ether linkages which may bridge between two carbohydrate chains as: Ri - O - Si(OH) 2 - O - R 2 or Ri - O - Si(OH) 2 - O - Si(OH) 2 - O - R 2 .
  • Silanol compound, (R t ) 2 Si (OH) 2 can also be a crosslink agent to form (R ⁇ ) 2 Si (- O - RiX - O - R 2 ), where Ri and R 2 are carbohydrate chains and R 4 can be a methoxy group, - OCH 3 , or other components of the silanol compound.
  • the free hydroxyl group, - OH, of silicon is a possible crosslink site to a carbohydrate.
  • the free -OH group of silicon can also react with serine or threonine of core protein to form proteoglycans, Ri- O - Si(OH) 2 - O - Serine - Protein, or Ri - O - Si(OH) 2 - O - Threonine - Protein.
  • the free -OH group of silicon reacts with hydroxylysine, the crosslink may bridge between polysaccharide and collagen, R 1 - O - Si(OH) 2 - O - hydroxylysine - Collagen.
  • boron may be the crosslink agent between collagen chains to form a strong bone matrix.
  • Boron in the form of boric acid, B( ⁇ 0H) 3 , can link to collagen fortified or bound with calcium to form bone matrix: - Collagen - Hydroxylysine - O - B(OH)- O - Hydroxylysine - Collagen - Calcium(b o und)- Hydroxylproline in collagen can also link to boron as well.
  • Boric acid is toxic, even lethal, in amounts of grams. In milligram quantities, boric acid is used as an anti-bacterial and anti ⁇ fungal food preservative.
  • Other boron compounds such as calcium borogluconate, can be used to build bone.
  • the severity of calcified formation 108 at the endplatelO ⁇ increases with age.
  • more than half of elderly L4-5 specimens showed separations or gaps between the discs 100 and the adjacent vertebral bodies 159.
  • the separation indicates disconnection between the disc 100 and the adjacent vertebral body 159.
  • separation or disconnection between the disc 100 and vertebral body 159 is particularly serious. Shear stress forces at these levels are intense. Separation between disc 100 and vertebral body 159 can lead to spondylolisthesis - forward slippage of vertebral body 159 from the disc 100 below. Spondylolisthesis often impinges upon nerve roots 194 and even the spinal cord 123, a serious condition requiring surgical intervention.
  • Boron and/or silicon can play a vital role in the connection between bone and connective tissue, including the cartilaginous endplate 105, disc 100 and tendons.
  • a possible linkage between bone and connective tissue can be: - Collagen - Hydroxylysine - O- B(OH) - O - Serine - Protein - Threonine - O -Si(OH) 2 - O - R 1 , where the section containing Calcium ⁇ oun d ) - Collagen - Hydroxylysine - O - B(OH) - O - is bone, and the section containing - Serine - Protein - Threonine - O -Si(OH) 2 - O - Ri is connective tissue, such as cartilaginous endplate 105, annulus 316 or nucleus pulposus 128.
  • the basic glycosaminoglycan building blocks of as nutritional supplement for biosynthesizing chondroitin sulfate, keratan sulfate and hyaluronic acid include: sodium sulfate, potassium sulfate, glucuronic acid, glucose, galactosamine, galactose and glucosamine.
  • the building blocks as nutritional supplement for linking or crosslinking molecules include: xylose, serine, threonine, hydroxylysine, hydroxylproline, orthosilicic acid, silanol compound, boron compound, boric acid and calcium borogluconate. These linking elements are the connectors essential for structural formation of large and interconnecting biomolecules.
  • the building blocks for core protein and link protein are the amino acids: glycine, alanine, valine, leucine, isoleucine, lysine, arginine, histidine, aspartate, glutamate, asparagine, glutamine, cysteine, methionine phenylalanine, tyrosine and tryptophan.
  • catalytic compounds such as thiamine, riboflavin, niacin, pantothenic acid, pyridoxine hydrochloride, cyanocobalamin, biotin, folic acid and ascorbic acid, are essential in biosynthesizing proteoglycans.
  • adenine, guanine, thymine and cytosine are required for biosynthesizing deoxyribonucleic acid, DNA.
  • uracil, ribose and sodium phosphate are required for ribonucleic acid, RNA, transcripted from DNA.
  • elevated concentrations of nutrients 317 from the nutritional supplements by ingestion, injection or intravenous administering into bodily circulation can enhance uptake of nutrients 317 into the avascular disc 100 through diffusion to treat disc degeneration and back pain.
  • traction or traction bed 320 can increase the uptake of oxygen and nutritional supplements 317 into the disc 100 through convection.
  • the intervertebral disc 100 is usually in a compressed state from gravity and muscle tension. Traction pulls vertebrae apart to expand the disc 100 to increase disc volume and to decrease disc pressure.
  • oxygen and nutritional supplement 317 in bodily circulation flow into the low pressure disc 100 through convective endplate flows 326 and annular flows 325. Diffusion and convective flows can be further intensified with additional oxygen pressure in the hyperbaric chamber 318.
  • FIG 33 shows a patient on a traction bed 320 within a hyperbaric chamber 318, partially submerged in solution 330 and strapped 332 with ultrasound transducers 331 posterior-laterally.
  • the solution 330 can be heated to relax the muscles to minimize tensile forces required to expand the disc 100.
  • muscle relaxants and/or local application of heat can also be used with traction.
  • the solution 330 can be saline or fortified with nutrients 317 in the solution.
  • a gel between the ultrasound transducer 331 and the skin can be used.
  • Vascular restriction or dilation can significantly affect the availability of nutrients diffusing into the avascular disc 100.
  • a US Army study shows that cigarette smoking increases the risk of low back pain (O'Connor FG, Marlowe SS: Low back pain in military basic trainees. A pilot study, Spine, Aug:18(10):1351-1354, 1993). A subsequent study from Finland confirms that cigarette smoking leads to back pain through disc degeneration and spinal instability (Fogelholm RR, Alho AV: Smoking and intervertebral disc degeneration. Med Hypotheses, Apr; 56(4) 537-539* 2001).
  • disc degeneration can also be initiated by poor blood circulation.
  • Patients with abdominal atherosclerosis obstruction in the arteries
  • have a significantly higher risk of experiencing low back pain Kerunlahti M, Tervonen O, Vanharanta H, Ikko E, Suramo I: Association of atherosclerosis with low back pain and the degree of disc degeneration, Spine, Oct 15; 24(20) 2080-2084, 1999.
  • inadequate blood supply to the cartilaginous endplates 105 or periphery of the disc 100 leads to disc degeneration.
  • vasodilators dilate or open blood vessels and capillaries to enhance blood flow to the calcified endplates 105 and periphery of the degenerated disc 100.
  • the supply or availability of nutrients and oxygen 317 from blood vessels increases to nourish and regenerate tissue within the deprived intervertebral disc 100.
  • the vasodilator can be adenosine, adrenomedullin, alkyl nitrite, amlodipine besylate, amyl nitrate, bradykinin, butyl nitrite, diazoxide, fenoldopam, fiunarizine, hydralazine, isobutyl nitrite, isosorbide dinitrate, kinin, mannitol, minoxidil, niacin, nicardipine, nimodipine, nitric oxide, nitroglycerin, papaverine, pentaerythritol tetranitrate, pentoxifylline, piperazine, prazosin, prostacyclin, protaglandin E-I (alprostadil), sildenafil citrate, sodium nitrite, sodium nitroprusside, tetrahydrocannabinol, theobromine, tolazoline
  • the vasodilator can be ingested, injected, intravenous administered or inhaled.
  • the vasodilator can be delivered in a pill, syringe, intravenous bag or canister.
  • the vasodilator can also be used with nutritional supplements, traction devices, oxygen, hyperbaric chamber and/or ultrasound to further enhance diffusion and convective uptake for repairing the degenerated disc 100.
  • the intervertebral disc 100 is expandable or inflatable. However, the water is not retained when compressive loads return, unless more sulfated glycosaminoglycans or proteoglycans are available to retain the water within the disc 100.
  • hyperbaric oxygen pressure within the chamber 318 with traction the rate of water, nutrients and oxygen 317 uptake into the disc 100 is intensified through convective endplate flow 236 and annular flow 325.
  • oxygen uptake into the disc 100 is concentrated by the increased oxygen partial pressure in the hyperbaric chamber 318.
  • Oxygen and nutrients 317 are used to biosynthesize chondroitin and keratan sulfate to retain water and restore swelling pressure for sustaining compressive loads.
  • the combination of traction bed 320 and hyperbaric chamber 318 with high partial pressure of oxygen is used to treat disc degeneration and back pain.
  • a disc degenerative model was made using rat tails (Nishimura K., Mochida J: Percutaneous reinsertion of the nucleus pulposus, Spine, 23(14), 1531-9, 1998). A tail section involving three discs was twisted or rotated 45° and held for 2 weeks.
  • the section was then compressed by coil springs and held for a period of time. AU discs within the section degenerated quickly. The experiment was repeated. The discs were injected with additional nucleus pulposus from donor discs. Disc degeneration of the injected discs was significantly delayed. This experiment demonstrated the significance of sustainable swelling pressure from the water retained by the sulfated glycosaminoglycans. In summary, disc height is more likely to be maintained to protect the disc 100 when water is retained, even under extreme compressive loads.
  • Severity of endplate occlusion varies with age, genetic factor and life style. Uptake of fluid, nutrients and oxygen 317 depends on diffusion, convection and absorbency of the sulfated glycosaminoglycans. In mildly occluded endplates 105, daily nutritional supplements as mentioned before may be adequate to enhance diffusion of nutrients 317 into the intervertebral disc 100 to biosynthesize sulfate glycosaminoglycans. In moderately occluded endplates 105, oxygen inhalation can boost the uptake of both nutrients and oxygen 317 into the disc 100 in conjunction with the nutritional supplements, especially in the supine position.
  • Vasodilator opens blood vessels and capillaries at or near endplates 105 and the periphery of. the degenerated disc 100 to shorten the distance and improve the exchange of nutrients and waste between the degenerated disc 100 and bodily circulation.
  • traction is useful to enhance convective flow to restore the water retaining sulfated glycosaminoglycans and proteoglycans within the disc 100.
  • combinations of hyperbaric chamber 318, traction, nutritional supplements, vasodilator and ultrasound can be used to re-supply and repair the degenerated disc 100 with nutrients and oxygen 317.
  • Nutrients and oxygen 317 carried by the enhanced endplate flow 326 or annular flow 325 reach deep into the inner disc 100 and produce more sulfated glycosaminoglycans within the nucleus pulposus 128.
  • the newly produced glycosaminoglycans or proteoglycans provide additional swelling pressure within the inner disc 100, as if re-inflating a flat tire.
  • Restoration of swelling pressure within the nucleus pulpous 128 recreates the tensile stresses within the collagen fibers of the annulus 316, reducing the inner bulging and shear stresses between the lamellae of the annulus 316.
  • Disc bulging reduces and nerve impingement 329 is minimized.
  • the load on facet joints 129 is significantly lifted. The motion segment is stabilized. Disc space narrowing ceases or is reversed.
  • oxygen supplied by increased partial pressure in the hyperbaric chamber 318 may drastically reduce the anaerobic production of lactic acid, thus decreasing chemical irritation and pain.
  • uptake of sulfate increases production of chondroitin sulfate and keratan sulfate.
  • production of chondroitin sulfate may be favored over the anaerobic production of keratan sulfate, thus increasing the water-retaining capability in the disc 100.
  • the operative therapeutic pressure for treating back pain ranges between 1 and 5 ATA.
  • the most appropriate therapeutic pressure should be 1 to 2.5 ATA.
  • the pressurized gas can contain between 15% and 100% oxygen.
  • observation of patients by a trained operator is required.
  • Nitrogen, helium, neon and/or other gases can be used to blend with oxygen to avoid oxygen toxicity.
  • Some common compressed air for diving, such as Nitrox, Trimix, Heliox, Heliair, Neox, can also be used to pressurize the hyperbaric chamber 318.
  • gas or mixture of gases can be used in series to (1) minimize time within the hyperbaric chamber 318, (2) avoid oxygen toxicity, (3) maximize treatment effectiveness, and (4) prevent nitrogen narcosis, hi addition, the patient can also breathe through a mask with gases other than the one used to pressurize the chamber 318.
  • the hyperbaric chamber 318 can be made with steel, aluminum, acrylic and/or other material.
  • the chamber 318 is equipped with air inlet 279, inlet valve 280, air outlet 281, outlet valve 282, entry hatches, airlock(s), two-way intercom, closed-circuit television, carbon dioxide scrubber and other equipment.
  • the carbon dioxide scrubber within the pressure chamber 318 can be made with soda lime (75% calcium hydroxide, 20% water, 3% sodium hydroxide, 1% potassium hydroxide).
  • the airlock allows medicines, instruments, food, drink, bedpan or other items to enter without excessively changing the pressure within the chamber 318.
  • the chamber 318 may also be large enough to accommodate more than one patient.
  • the traction bed 320, jack 323, tilt bed 320, tensile machine 322 and other equipment within the hyperbaric chamber 318 are preferred to operate without using electricity to avoid sparks or fire in the presence of high oxygen partial pressure.
  • the equipment can be operative using hydraulic, air, gears or other means.
  • the traction can also be created by weight or spring. The gas is frequently removed from the chamber to prevent build up of oxygen, which could provoke fire or oxygen toxicity.
  • the upper holder 285 can be a harness 285 around the chest, connected to an upper strap 287.
  • the upper holder 285 can also be two axillary supports with soft shape-conforming wrappers for pulling from under the arms of the patient.
  • the upper holder 285 can be one or two handles with soft wrappers for the hands.
  • the handles also contain a switch. When the hands grab the handles, traction or tensile force begins. When the patient lets go of the handles, traction stops; then the handles reverse direction for about a foot, 0.3 meter, to allow the patient to re-grab the handles to resume traction treatment. Tensile forces or traction can be voice activated by the patient and/or operator.
  • the tensile force can also be programmed with upper limits, intermittent, continuous, cycles, step-wise intensities, set time and/or combination.
  • the tensile force can be on hold, creating a static stretch on the spine. Traction can be operated by movement of the upper holder 285, lower holder 286, or both.
  • the lower holder 286 can be a harness 286 around the waist connected to a lower strap 288.
  • the tensile force is related to the tilt angle, body weight of the patient and friction between the patient and the bed 320.
  • the head-down tilt traction bed 320 does not require upper body support 285, although upper support 285 can intensify the traction.
  • the compartment of the hyperbaric chamber 318 can accommodate the traction bed 320 with tilt angles ranging from 0° to 90 °, where 0° is horizontal and 90 ° is vertical with head down.
  • the tilt of the traction bed 320 can be achieved with a jack 323 or lifting element.
  • Traction bed 320, head-down tilt bed 320, upper holder 285, lower holder 286, foot holder 324, head harness 321 and tensile machine 322 are traction devices design to provide tensile force to the disc 100.
  • the term traction is used as a device or method.
  • the purpose of traction, tensile force, tension, stretching and/or bending in this invention is related to methods and devices to promote uptake of nutrients and oxygen 317 into the deprived disc 100.

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  • Chemical & Material Sciences (AREA)
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Abstract

Le disque intervertébral est avasculaire. Avec le vieillissement, les plaques d'extrémité sont occluses par des couches calcifiées. La diffusion de nutriments et d'oxygène dans le disque diminue. Le disque dégénère et la douleur survient. La traction, une chambre hyperbare, des suppléments nutritionnels, un vasodilatateur et/ou des ultrasons sont les solutions proposées par l'invention pour augmenter l'absorption de fluide, de nutriments et d'oxygène afin de régénérer des glycosaminoglycanes sulfatés, de restaurer la pression de gonflement, de supporter des charges de compression et de soulager les douleurs dorsales.
PCT/US2005/032632 2004-09-14 2005-09-14 Traitement de la cause des douleurs dorsales par traction dans une chambre hyperbare WO2006031844A2 (fr)

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US61013504P 2004-09-14 2004-09-14
US60/610,135 2004-09-14
US62664404P 2004-11-10 2004-11-10
US60/626,644 2004-11-10

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102010045185A1 (de) * 2010-09-13 2012-03-15 Marianne Broendlund Stoffgemisch, Verwendung und Infusionslösung
CN102397137A (zh) * 2011-10-09 2012-04-04 杭州新颖氧舱有限公司 一种加压氧舱治疗系统气压控制方法
KR101584348B1 (ko) * 2014-04-07 2016-01-13 (주)아이벡스메디칼시스템즈 고압산소캡슐

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Publication number Priority date Publication date Assignee Title
US2700384A (en) * 1952-02-01 1955-01-25 Harry S Ivory Treatment chamber apparatus
US2796861A (en) * 1952-12-23 1957-06-25 Frederick A Smith Blood circulation
US6592501B1 (en) * 2001-09-10 2003-07-15 Billy Jack Mayes Back rehab exercise table
US20040171974A1 (en) * 2002-12-16 2004-09-02 Cert Health Sciences, Llc Method and apparatus for therapeutic treatment of back pain

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Publication number Priority date Publication date Assignee Title
US2700384A (en) * 1952-02-01 1955-01-25 Harry S Ivory Treatment chamber apparatus
US2796861A (en) * 1952-12-23 1957-06-25 Frederick A Smith Blood circulation
US6592501B1 (en) * 2001-09-10 2003-07-15 Billy Jack Mayes Back rehab exercise table
US20040171974A1 (en) * 2002-12-16 2004-09-02 Cert Health Sciences, Llc Method and apparatus for therapeutic treatment of back pain

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Title
KASAI Y ET AL: "Change of Barometric Pressure Influences Low Back Pain in Patients with Vacuum Phenomenon Within Lumbar Intervertebral Disc" JOURNAL OF SPINAL DISORDERS & TECHNIQUES, vol. 15, no. 4, 2002, pages 290-293, XP009058856 *

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102010045185A1 (de) * 2010-09-13 2012-03-15 Marianne Broendlund Stoffgemisch, Verwendung und Infusionslösung
CN102397137A (zh) * 2011-10-09 2012-04-04 杭州新颖氧舱有限公司 一种加压氧舱治疗系统气压控制方法
KR101584348B1 (ko) * 2014-04-07 2016-01-13 (주)아이벡스메디칼시스템즈 고압산소캡슐

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