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WO2013087019A1 - Système de détermination des angles de traitement d'un dispositif de décompression vertébrale - Google Patents

Système de détermination des angles de traitement d'un dispositif de décompression vertébrale Download PDF

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Publication number
WO2013087019A1
WO2013087019A1 PCT/CN2012/086601 CN2012086601W WO2013087019A1 WO 2013087019 A1 WO2013087019 A1 WO 2013087019A1 CN 2012086601 W CN2012086601 W CN 2012086601W WO 2013087019 A1 WO2013087019 A1 WO 2013087019A1
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WIPO (PCT)
Prior art keywords
patient
tension
spine
tensioning device
angle
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2012/086601
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English (en)
Inventor
Song REN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
BEIJING RYZUR AXIOM MEDICAL INVESTMENT Co Ltd
Original Assignee
BEIJING RYZUR AXIOM MEDICAL INVESTMENT Co Ltd
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Publication of WO2013087019A1 publication Critical patent/WO2013087019A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • A61H1/008—Apparatus for applying pressure or blows almost perpendicular to the body or limb axis, e.g. chiropractic devices for repositioning vertebrae, correcting deformation
    • 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
    • A61H2201/01—Constructive details
    • A61H2201/0103—Constructive details inflatable
    • 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
    • A61H2201/12—Driving means
    • A61H2201/1207—Driving means with electric or magnetic drive
    • A61H2201/1215—Rotary drive
    • 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
    • A61H2201/12—Driving means
    • A61H2201/1238—Driving means with hydraulic or pneumatic drive
    • 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
    • A61H2201/1623—Back
    • 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
    • A61H2201/1645—Physical interface with patient kind of interface, e.g. head rest, knee support or lumbar support contoured to fit the user
    • A61H2201/1647—Physical interface with patient kind of interface, e.g. head rest, knee support or lumbar support contoured to fit the user the anatomy of a particular individual
    • 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
    • A61H2201/50—Control means thereof
    • A61H2201/5007—Control means thereof computer controlled
    • 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
    • A61H2201/50—Control means thereof
    • A61H2201/5058—Sensors or detectors
    • A61H2201/5064—Position sensors
    • 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
    • A61H2201/50—Control means thereof
    • A61H2201/5058—Sensors or detectors
    • A61H2201/5092—Optical sensor
    • 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
    • A61H2205/00—Devices for specific parts of the body
    • A61H2205/08—Trunk
    • A61H2205/081—Back

Definitions

  • the present invention relates to a system that applies tension to a patient's spine to treat the spine. More specifically, the present invention relates to a system that applies tension to a patient's spine through a range of angles, and that accounts for and adjusts treatment angle based on bed / patient position dynamically.
  • Decompression therapy is a derivative of traditional traction-based therapy, whereby the spine is placed into a state of tension by an outside force (such as by a therapist manually or by an automated process). The spine is typically held in a continuous state of tension during traditional traction-based therapy.
  • Decompression therapy differs from traditional traction therapy in that tension is applied to the spine at a specific angle.
  • various tensile forces are applied or cycled throughout the treatment period such that paraspinal muscles are relaxed and fatigued, allowing for interdiscal separation.
  • the spinal vertebrae are separated in order to allow the intervertebral discs to realign into their proper positions. This action allows herniated discs time to heal in a non-loaded state. Additionally, nutrient-rich spinal fluid (nucleus pulposa) is drawn to the sites of tension via the pressure drop created by the separation of the vertebrae.
  • nutrient-rich spinal fluid nucleus pulposa
  • Para-spinal muscles may react involuntarily to the "stretching" of the spine by tensing in opposition to the force.
  • the conscious human patient may involuntarily and/or subconsciously flex the spinal muscles in reaction to tensile forces. Either or both patient reactions degrade the effectiveness of spinal traction or spinal decompression therapy.
  • a common spinal decompression therapy system utilizes a non- feedback- providing tension producing actuator (any type of electro-mechanical, pneumatic, magnetic, hydraulic, or chemical actuator) connected to a patient via a patient interface device, such as a tension strap and / or patient harness.
  • a patient interface device such as a tension strap and / or patient harness.
  • the patient lay supine upon a treatment bed, head distal to the applied tension source.
  • An upper body patient harness secures the upper patient body to the distal end of the bed (that end of the bed furthest from the source of tensile force generation).
  • a lower body harness secures about the waist, and serves as the point at which the tension strap is connected.
  • Tension-producing actuator output is increased or decreased to produce resultant tension changes at the point where the strap is attached to the patient.
  • a linear actuator (any type of electro- mechanical, pneumatic, magnetic, hydraulic, or chemical actuator) is utilized to raise and lower the point at which the tension strap pulls from (treatment positioner), relative to the place of attachment to the patient, thus adjusting the angle of applied tension.
  • the system also includes a tension measuring device (e.g., a loadcell) that is connected inline with the tension-producing actuator and patient to communicate tension metrics to a tension-producing actuator controlling device (e.g. computer).
  • a tension-producing actuator controlling device e.g. computer
  • the system operates as a controlled-feedback loop whereby a planned tension profile can be applied to the patient and the actual applied forces can be verified by the computer.
  • the point at which the tension strap pulls from relative to the place of attachment to the patient is typically fixed during application of tension.
  • the applied tension can be modeled as two force vectors, one inline with the patient's spine and away from the head, and one perpendicular to the patient's spine.
  • the direction of the horizontal component of the applied tension resultant would remain the same, however the direction of the vertical component of the applied tension resultant would be reversed.
  • the tension of spinal decompression is applied at an angle, and specific angles (which are specific to each device's design) affect a specific interdiscal location(s).
  • the change in treatment angles will result in the change in the particular part where the decompression stress acts on the spine, and it can be found that the position at which the largest stress is applied to the spine is relative to the decompression angles, the decompression angles being different, the position at which the largest stress is applied to being different, by the three dimensional finite element simulation mechanics experiment method and the experiment method in which the angle is changed and the spine force situation is observed in the experiment, etc.
  • the relation between the decompression angles and the largest stress position is that the largest stress position is nearer to the caudal vertebra when the decompression angle is smaller, and on the contrary the largest stress will move upwards the thoracic vertebra as the decompression angles increase. Therefore, the angle at which the decompression stress is applied should be appropriately adjusted according to the diseased interdiscal position, such that the diseased part can obtain the most effective decompression stress.
  • the ability to locate the site(s) of spinal elongation in the spine by adjusting the angle of applied tension allows healthcare providers to treat location specific injuries, and locating the site(s) of spinal elongation maximizes the therapeutic benefit per therapy session.
  • the diseased site can not obtain the most effective decompression stress, if the traction and decompression is performed at a parallel angle (0° , the bed horizontal) then the largest stress is near to caudal vertebra, additionally, if decompression angles setting is not present, the decompression force will be acted on the entire spine so the effective decompression force acted on the lesion (diseased intervertebral space) is very little, thereby the effective treatment of the diseased intervertebral space can not be achieved.
  • the problem of the second case is that using the previous angle data of the machine or the angle setted manually has a reference base, namely clinical experience or laboratory data , but the problem is that the human spine is not equal to the ideal spine model in computer digitization or testbook so the best decompression effect can not be obtained, because that the difference in physiology, sex, age, physique, job nature, etc, can result in the difference in spine physiological curve, and even that there will be large deviation in lesion angle location if the same constant angle set is still used mechanically during different treatment date of the same patient.
  • the most appropriate tension angle applied on the spine L3 is calculated automatically by configuring the shift sensor in the horizontal and vertical direction and according to the shift data transmitted by the sensor and in conjunction with the HPT best fitted curve of the human spine after the patient adjust his body position. Because L3 is located more accurately compared to the old scheme, L1-L5 angle location can be also relatively accurate compared to the old scheme, more accurate angle location of the diseased site can be achieved and further the decompression force can be more accurately applied on the diseased site.
  • the present invention seeks to demonstrate a unique method for locating the apex of lordosis, the third vertebra of the lumbar spine, upon a spinal decompression treatment bed consistently across various patient populations and anthropometries. Further, utilizing the apex of lordosis and locating the origin of the resultant tension applied to the patient at the sacrum, to calculate segmental treatment angles based on either average or ideal spinal models which takes into account the horizontal position of the treatment bed and the vertical position of the treatment positioner. In general, it is not necessary for different patients' lower spines that the point at which the tension strap pulls from is in the same position horizontally. The treatment bed is designed to slide towards and away from the point at which the tension strap pulls from, to accommodate differences in patient height. Regardless of the patient's height, the location of the lower spine is known. This is accomplished in two ways.
  • a lordotic support within the treatment bed which acts to position the lordotic curve of the patient spine in the same place on the treatment bed.
  • the lordotic support may be a raised location in the bed such as a foam bulge, or may be an adjustable support, such as an inflatable cushion.
  • the lordotic support serves two purposes, both allowing the device to calculate treatment angles based on a known location of the lordotic spine, and serving as a fulcrum about which the lower spine is aligned and elongated.
  • a position sensor in the treatment bed which detects treatment bed movement and location.
  • the treatment bed utilized a linear actuator to move the treatment bed horizontally towards and away from the tension source.
  • a position sensor for this application may be a potentiometer, relative or absolute encoder, or optical device located within the actuator.
  • the position sensor may also be mounted external to the actuator.
  • the metrics from the horizontal treatment bed position sensor are communicated to a processing unit for use in calculating dynamically the treatment angle.
  • the horizontal location of the apex of lordosis of the spine in relation to the tension source can be known regardless of variations in patient height.
  • the tension source is typically fixed in position horizontally away from the patient in common traction and spinal decompression devices.
  • the tension source may be raised and lowered, relative to the patient, to increase and decrease the angle of tension applied to the patient.
  • the tension source may be fixed in position vertically, relative to the patient.
  • a system of rollers may be utilized to raise and lower the point at which the tension source pulls from, relative to the patient, to increase and decrease the angle of tension applied to the patient.
  • an actuator of some type is utilized to raise and lower either the tension source or the point at which the tension source pulls from. Incorporating a position sensor in the actuator controlling the vertical location of the tension source or the point at which the tension source pulls from provides vertical position metrics for a processing unit for use in calculating dynamically the treatment angle.
  • the lower patient harness is designed to originate the resultant tension vector on the posterior side of the body at the sacrum, such that changes in treatment angle affect directly that spinal structure. If the origin were located at the patient waist on the posterior side of the body above the sacrum, then patient girth may have to be taken into account when calculating treatment angle. It is known in the art of spinal decompression that for the lumbar spine, a reference for initially tensioning the spine is 1 ⁇ 2 of the patient's body weight. This tension level is at least sufficient to mobilize the spine and to lift and rotate it through the treatment angles.
  • the apparatus for the proper mobilization of the spine being created, designation of the proper interdiscal treatment angles follow.
  • the spinal decompression device is designed for a patient laying supine or prone on a treatment bed, lateral recumbent position, or standing, the proper radiographical data need be selected.
  • the proper radiographical data need be selected.
  • utilizing radiographical measurements made on standing patients with spines loaded by gravity may not be appropriate for a device designed around a patient lying supine on a bed with a bolster under the knees.
  • the patient is lying supine with a bolster under their knees, which would necessitate utilization of either ideal or average segmental lordosis measurements for designation of treatment angles. Consideration may be given to use of segmental measurements based on those with back pain.
  • Treatment angle calculation proceeds by visualizing the triangle formed by three points. These three points define the sides of the triangles, the lengths of the vertical and horizontal components allow for the calculation of the treatment angle originating at the apex of lordosis.
  • the point at which the tension source resides vertically relative to the patient (or in the case of a vertically-fixed tension source then the point at which the tension source pulls from vertically relative to the patient) defines a vertical elevation above some starting point. That starting point is the point within that vertical plane that is bisected by the center-top of the lordotic support horizontally. The distance between the two points forms the vertical distance for the treatment angle calculation.
  • the treatment angle originating at the apex of lordosis can be calculated by utilizing the arc-tangent function:
  • a tensioning device comprising: A patient-positioning means configured to repeatedly align a target region of a patient spine; A tension-producing actuator configured to place a patient spine in tension; and A positioning device operationally configured to position tension producing actuator relative to target region of patient spine; and A patient interface device operationally configured to interface tension producing actuator with patient spine; and A display operationally configured to provide data regarding resultant tension vector to the user or healthcare provider; Wherein the tensioning device is operationally configured to concentrate tension at patient spine treatment site through geometric positioning of the patient spine, with respect to spinal morphology, relative to tension vector.
  • the patient positioning means includes a treatment bed.
  • the treatment bed includes a region identified as the alignment-region over which a target region of the patient spine should be positioned.
  • the alignment-region of the treatment bed includes a split in the treatment bed, such as between an upper mattress and a lower mattress of the treatment bed.
  • the treatment bed includes a means of physically moving the location of portions of the treatment bed.
  • the tension producing actuator includes an electro-mechanical device which generates torque through rotation.
  • the tension producing actuator includes a means of increasing or decreasing torque generated.
  • the positioning device includes a means by which increases and decreases in the height of the tension producing actuator relative to the target region of the patient spine are accomplished.
  • the patient interface device includes a decompression strap connected to a patient harness.
  • One end of the decompression strap includes a connection to the rotation of the tension producing actuator.
  • the decompression strap includes a connection to a harness at its opposite end.
  • the patient harness cradles a portion of the patient spine.
  • the patient interface device is operationally configured to translate torque generated by the tension producing actuator to the patient spine.
  • a control system allows for user or healthcare provider input and includes a means of user input for physically moving the location of the target region of the patient spine relative to a location on the device.
  • the control system calculates the resultant tension vector angle between the target region of the patient spine and tension producing actuator along patient interface device, and includes a display or means for communicating this angle to the user or healthcare provider.
  • the control system provides a means of user input for physically moving the location of the tension producing actuator relative to a location on the device.
  • the control system allows for a user or healthcare provider to visually assess or through patient physical palpitation modify patient position and tension producing actuator position to align the resultant tension vector according to a geometric angle.
  • the control system indicates the region of the spine where resultant tension will be concentrated based on empirical calculation of said location relative to a spinal model and mathematical and medical assumptions.
  • the control system calculates region of the spine where resultant tension will be concentrated based on ideal spine models arrived at through clinically cited spinal morphology studies.
  • the control system allows the user or healthcare provider to adjust target spinal region relative to a location on the device, and to enter a vertebral area of treatment or angle of resultant tension vector, the control system then adjusting tension producing actuator position automatically to accommodate user input.
  • Figure 1 illustrates a side view of a spinal therapy system formed according to an embodiment of the present invention.
  • Figure 2 illustrates the coccyx, sacrum, and lumbar spine, the lumbar spine being modeled about an elipse, showing angles between adjacent vertebra.
  • Figure 3A, 3B, 3C and 3D respectively illustrates a comparison of methods used to measure segmental lordosis.
  • Figure 4A and 4B respectively illustrates an adjustable lower patient harness with an adapter for a tension source connection device located near the base of the sacrum, formed according to an embodiment of the present invention.
  • Figure 5 illustrates a side view of a spinal therapy system utilizing a lordotic support, specific patient positioning, and treatment angle structure based on Figure 2, formed according to an embodiment of the present invention.
  • Figure 6A and 6B respectively illustrates the system of Figure 3, but with corrections for treatment angle based on horizontal position of the treatment bed, formed according to an embodiment of the present invention.
  • Figure 7A and 7B respectively illustrates two side views of a coccyx, sacrum, and lumbar spine before and after the application of tension at a specific angle designed to align the sacrum and lowest lumbar vertebra (SI and L5 respectively) and to elongate that interdiscal space (L5-S1), formed according to an embodiment of the present invention.
  • Figure 8A and 8B respectively illustrates two side views of a coccyx, sacrum, and lumbar spine.
  • the upper view 8A illustrates the lower spine after the application of tension at an angle designed to align the sacrum and lowest lumbar vertebra (S 1 and L5 respectively) and to elongate that interdiscal space (L5-S1).
  • the lower view 8B illustrates the upper view after the application of tension at an additional specific angle designed to align the lowest lumbar vertebra with the fourth distal lumbar vertebra (L5 and L4 respectively), and to elongate the interdiscal spaces (L5-S1 and L4-L5), formed according to an embodiment of the present invention.
  • Figure 9A and 9B respectively illustrates two side views of a coccyx, sacrum, and lumbar spine.
  • the upper view 9A illustrates the lower spine after the application of tension at an angle designed to align the sacrum with the lowest lumbar vertebra (SI and L5 respectively) and the lowest lumber vertebra with the fourth lumbar vertebra (L5 and L4, respectively), and to elongate those interdiscal spaces (L5-S1 and L4-L5).
  • the lower view 9B illustrates the upper view after the application of tension at an additional specific angle designed to align the fourth lumbar vertebra with the third distal lumbar vertebra (L4 and L3 respectively), and to elongate the interdiscal spaces (L5-S1, L4-L5, and L3- L4), formed according to an embodiment of the present invention.
  • Figure 10A and 10B respectively illustrates two side views of a coccyx, sacrum, and lumbar spine.
  • the upper view 10A illustrates the lower spine after the application of tension at an angle designed to align the sacrum with the lowest lumbar vertebra (S 1 and L5 respectively), the lowest lumbar vertebra with the fourth lumbar vertebra (L5 and L4 respectively) and the fourth lumbar vertebra with the third lumbar vertebra (L4 and L3 respectively), and to elongate those interdiscal spaces (L5-S1 , L4-L5, and L3-L4).
  • the lower view 10B illustrates the upper view after the application of tension at an additional specific angle designed to align the third lumbar vertebra with the second distal lumbar vertebra (L3 and L2 respectively), and to elongate the interdiscal spaces (L5-S1, L4-L5, L3-L4, and L2-L3), formed according to an embodiment of the present invention.
  • Figure 11A and 11B respectively illustrates two side views of a coccyx, sacrum, and lumbar spine.
  • the upper view 11A illustrates the lower spine after the application of tension at an angle designed to align the sacrum with the lowest lumbar vertebra (S 1 and L5 respectively), the lowest lumbar vertebra with the fourth lumbar vertebra (L5 and L4 respectively), the fourth lumbar vertebra with the third lumbar vertebra (L4 and L3 respectively) and the third lumbar vertebra with the second lumbar vertebra (L3 and L2 respectively), and to elongate those interdiscal spaces (L5-S1, L4-L5, and L3-L4).
  • the lower view 1 IB illustrates the upper view after the application of tension at an additional specific angle designed to align the second lumbar vertebra with the first distal lumbar vertebra (L2 and LI respectively), and to elongate the interdiscal spaces (L5-S1, L4-L5, L3-L4, L2-L3, and L2-L1), formed according to an embodiment of the present invention.
  • Figure 12 illustrates a flowchart demonstrating an algorithm for calculating treatment angle based on bed position (horizontally towards and away from the tension source) and vertical tension source position, formed according to an embodiment of the present invention.
  • Figure 1 illustrates a spinal therapy system 10 used to treat a patient 110 formed according to an embodiment of the present invention.
  • the system 10 includes a microprocessor, control system, or computing device 190 having firmware and/or software that operates to utilize and control an actuator 170.
  • the computing device 190 is configured to interface with a user, such as by use of a monitor and keyboard setup.
  • the actuator 170 may be electronically, hydraulically, pneumatically, or mechanically operated.
  • the actuator 170 is connected to a patient 110 via a patient interface device 120.
  • the actuator 170 may be operated through a system of gears or pulleys such that the tensile forces applied to the patient 110 by the patient interface device 120 are carefully controlled.
  • This system 10 is used to perform decompression therapy on the patient 1 10 by applying cycles of tensile forces from the actuator 170 on the spine 108 of the patient 110 through the interface device 120.
  • the system 10 may be used to perform traction therapy without use of cycles of tensile forces.
  • the patient 1 10 is positioned supine on a mechanical apparatus 100 that may be a flat surface such as a bed or table.
  • the bed 100 includes a head end 104 where the patient 110 lay his or her head and a base end 106 where the patient 110 lay his or her legs and feet.
  • the bed 100 is positioned such that the patient 100 may be easily placed into alignment for treatment with the system 10. Additionally, the bed 100 may employ arm supports or rails to position the patient 1 10.
  • the patient 110 wears a lower-body harness 1 18 that is connectable to the patient interface device 120. This lower-body harness allows for connection to the patient interface device 120 at or near the base of the sacrum, or is designed to locate the origin of the resultant tension vector at or near the base of the sacrum.
  • the patient may wear any other appropriate device that is configured to connect the patient 110 to the interface device 120, provided the device position the origin or locate the origin of the resultant tension vector at or near the base of the sacrum.
  • the patient 1 10 wears an upper-body harness 1 19 that is connectable to the head end 104 of the bed 100.
  • the upper-body harness 1 19 secures the upper body of the patient 1 10 to the bed 100, and keeps the upper body of the patient 110 from moving towards or away from the tower 130 which houses the actuator 170 and interface positioning device 140.
  • the healthcare provider positions the patient's 110 lumbar spine 108 over an adjustable lordotic support 1 12.
  • the adjustable lordotic support 1 12 is pneumatically inflated and deflated to accommodate various degrees of lumbar lordosis between patients 110.
  • the lordotic support 1 12 may be adjustable or fixed in shape, and may be adjustable by several methods, including pneumatic, electro-mechanical, hydraulic, chemical, etc.
  • the healthcare provider positions the apex of lordosis, the third lumbar vertebra (L3), over the center-top of the lordotic support 112.
  • the healthcare provider places a knee bolster 117 under the patient's 110 knees, reducing pressure on the patient's 1 10 lower spine 108.
  • the lower-body harness 1 18 is connected to the actuator 170 by the patient interface device 120.
  • the harness 1 18 may be connected to the patient interface device 120 through a clip or buckle that may alternately be secured and removed.
  • the interface device 120 is configured to deliver and align tensile forces generated by the actuator 170 through the harness 118 along the spine 108 of the patient 110.
  • the interface device 120 may be a strap, belt, or cable that is positioned relative to the patient 1 10 via a patient interface positioning device 140.
  • the patient interface positioning device 140 may itself be moved to preferred positions by an vertical actuator 148, which may be a linear actuator, or any other type of electro-mechanical, pneumatic, hydraulic, or chemical actuator.
  • the vertical actuator 148 may contain a relative or absolute encoder, potentiometer, or optical distance sensor, for use in communicating the position of the patient interface positioning device 140 to an electronic communication hub 155 by way of arrow F.
  • the patient interface device 120 as it travels up and down via the patient interface positioning device 140 and vertical actuator 148, may pass thru a slot 145 in the front of the tower 130, which may utilize some form of flexible material to move with the patient interface device 120 and shield the inside of the tower 130 from outside interference.
  • the head end 104 and base end 106 mattresses of bed 100 may be moved together horizontally towards and away from the tower 130 via a horizontal actuator 114 and clevis, which may be a linear actuator or any of electro-mechanical, pneumatic, hydraulic, or chemical type. This would generally be done to accommodate patients 110 of various heights, such that those patient's 110 feet would not be uncomfortably near to or beyond the base end 106 of the bed 100.
  • the horizontal actuator 114 may contain a relative or absolute encoder, potentiometer, or optical distance sensor, for use in communicating the position of the lordotic support 112 and head end 104 mattress to either or both the computing device 190 and electronic communication hub 155.
  • the base end 106 mattress of the bed 100 is designed to be locked into place with and travel horizontally with the head end 104 mattress of the bed 100. It is also capable of unlocking from the head end 104 mattress of the bed 100, and traveling a fixed distance away from the head end 104 mattress of the bed 100 along linear guides. This function serves to allow the spine 108 to elongate more easily under tension, as opposed to slipping and sliding down the base end 106 mattress of the bed 100 were it fixed to the head end 104 mattress. Even less favorable for the free elongation of the spine with the decompression tension would be the case where the base end 106 mattress and head end 104 mattress were joined as in the case of a solid mattress.
  • the system 10 further includes a tensile force feedback system 160 which engages the interface device 120 between the actuator 170 and the lower-body harness 1 18.
  • the feedback system 160 may include a loadcell or dynamometer 150 that is positioned inline with the actuator 170 and is configured for electronically providing feedback to the electronic communication hub 155 as indicated by arrow E.
  • the electronic communications hub 155 is designed to collect and relay various system 10 metrics to the computing device 190 as indicated by arrow A. This device may synchronize various system 10 measurement device information into a single data stream A designed to be best utilized by the computing device 190.
  • the actuator 170 electronically communicates with, and is controlled directly by, an actuator controller 192 as shown by arrow B.
  • the actuator controller 192 is a servo-amplifier 192.
  • the actuator 170 may also be attached to, or connected inline with, an encoder 180 that is capable of communicating motor shaft position and other motor metrics with the servo-amplifier 192.
  • the servo-amplifier 192 may be capable of calculating any number of motor metrics, including work, position, distance, torque, and rate and electronically communicating those metrics to, and receiving them from, the computing device 190 as indicated by arrow C to the computing device 190.
  • the computing device 190 may be configured to communicate with the servo-amplifier 192, and the actuator 170, to monitor and to correct as needed the resultant tensile force and motor metrics applied by the actuator 170 from the servo-amplifier 192.
  • the computing device 190 may also be configured for use with a user interface system (e.g., keyboard and monitor) which communicates and deciphers the user's commands to the computer 190. This interface allows the user to structure treatment parameters.
  • a user interface system e.g., keyboard and monitor
  • This interface allows the user to structure treatment parameters.
  • all tension-producing and delivery apparatus are contained within a tower 130 located in a position relative to the patient 1 10.
  • spinal treatment begins by positioning the patient 110 correctly onto the bed 100.
  • the patient's head is positioned at the head end 104 of the bed 100, and the patient's feet are positioned at the base end 106 of the bed 100.
  • the patient 1 10 is outfitted with the lower body harness 118 such that the patient 110 is connected to the patient interface device 120, and the lower body harness 118 is configured to apply tensile forces to the spine 108 of the patient 110, the origin of the resultant tension vector located at or near the base of the sacrum.
  • the patient is outfitted with an upper body harness 119 which is fixed into position at the head end 104 of the bed 100.
  • the healthcare provider positions the patient's 1 10 apex of lordosis over the center-top of the lordotic support 112, adjusts the height of the support to match the curvature of the patient's lordosis there, and adjusts the upper-body harness 1 19 connection to the head end 104 of the bed 100 to make certain the upper body of the patient 1 10 is fixed into position on the head end 104 mattress.
  • a bolster 1 17 is placed under the patient's 110 knees.
  • the operator of the decompression system 10 may use the patient interface system of the computer 190 to select the proper treatment parameters for the therapy. The operator may then select a tension treatment program for the patient 110 and instruct the computing device 190 to execute the selected treatment profile.
  • the computing device 190 activates the servo-amplifier 192 and/or actuator 170 such that the actuator 170 rotates, for example in the direction of arrow D, to tighten the patient interface device 120 and thus apply tension to the patient's spine 108 through the lower body harness 118.
  • the computing device 190 adjusts the tensile output to follow the cycles of tensile forces defined in the treatment program entered by the user.
  • the program may include low and high tension plateaus above, by way of example only, 125 pounds, and may also include any number of decompression therapy variations cyclically applying tension to the patient's spine 108.
  • Figure 2 illustrates the Lumbar Lordosis Elliptical Model 205 formed of radiographic measurements over many patients.
  • Janik et al developed an idealized average subject anthropometric model of the lumbar lordosis from inferior of T12 to superior SI .
  • the elliptical model 205 represents the idealized path of the posterior longitudinal ligament along the posterior aspect of the vertebral bodies.
  • This model 205 represents one method by which spinal decompression device designers may designate treatment angles formed according to an embodiment of the present invention.
  • the ellipse 205 about which the spine 200 is modeled has minor axis B 210 passing through the inferior endplate 212 of T12 275 and a major axis A 215 perpindicular to the minor axis 210. Janik et al found the b/a raio of 0.32 to be the best fit for the data presented.
  • the lower spine 200 pictured in Figure 2 is composed of the first sacral vertebra 230 (SI), the fifth lumbar vertebra 225 (L5), the fourth lumbar vertebra 240 (L4), the third lumbar vertebra 250 (L3), the second lumbar vertebra 260 (L2), the first lumbar vertebra 270 (LI), and the twelfth thoracic vertebra 275 (T12).
  • the tangent lines in Figure 2 are drawn according to the Harrison Posterior Tangent (HPT) method.
  • HPT lines drawn along the posterior bodies of the bony vertebra are shown, the angle between adjacent tangent lines defining the segmental angle between vertebra per the elliptical model 205.
  • the segmental angle between L5 225 and SI 230, or L5-S1 is determined by the angle between the tangent lines ⁇ 235 and ⁇ 220.
  • the segmental angle between L4 240 and L5 225, or L4-L5, is determined by the angle between the tangent lines ⁇ 2 245 and ⁇ 235.
  • the segmental angle between L3 250 and L4 240, or L3-L4, is determined by the angle between the tangent lines ⁇ 3 255 and ⁇ 2 245.
  • the segmental angle between L2 260 and L3 250, or L2-L3, is determined by the angle between the tangent lines ⁇ 4 265 and ⁇ 3 255.
  • the segmental angle between LI 270 and L2 260, or L1-L2, is determined by the angle between the tangent lines ⁇ 5 280 and ⁇ 4 265.
  • FIG. 1 The segmental angles discussed above are utilized according to an embodiment of the present invention to determine angles specific to the device of Figure 1 for treating various portions of the lumbar spine 200.
  • Different radiographical methods and data may be more or less appropriate for a specific spinal decompression device design. It is important to choose measurement data that befits the patient's 110 position on the device, in the system of 10 that being supine and with a bolster under the knees.
  • Figure 3A, 3B, 3C and 3D respectively illustrates a comparison between two common methods for measuring segmental angle, the Harrison Posterior Tangent Method and the Cobb Angle Method.
  • Figure 6A and 6B show two side views of lower spines 300 and 301 and figure 6C and 6D show two comparative views of segmental angle geometry.
  • the lower spine of 300 composed of the first sacral vertebra 310 (SI), the fifth lumbar vertebra 31 1 (L5), the fourth lumbar vertebra 312 (L4), the third lumbar vertebra 313 (L3), the second lumbar vertebra 314 (L2), the first lumbar vertebra 315 (LI), and the twelfth thoracic vertebra 316 (T12) is shown modeled about an elliptical shape.
  • the HPT line 317 is drawn tangent to the posterior body of L5 311.
  • the HPT line 318 is drawn tangent to the posterior body of L4 312.
  • the angle 319 between the HPT lines 317 and 318 defines the value of the segmental angle between L4 312 and L5 311 , or L4-L5.
  • the Cobb Angle method is used to measure the segmental angle 336 between L4-L5.
  • lines 324 and 326 are drawn tangent to the inferior endplates of L5 320 and L4 322.
  • the choice of inferior or superior endplate depends on the application, however in Figure 3 the inferior and superior endplates of L5 320 are assumed to be parallel, the placement of the line 326 inferior or superior having no affect on the Cobb Angle measurement.
  • the line 328 is drawn perpendicular 332 to the line 324, and the line 330 is drawn perpendicular 334 to the line 326.
  • the angle 336 between lines 328 and 330 is the segmental angle between L4 322 and L5 320, or L4-L5.
  • the vertebra L5 340 and L4 342 are shown bounded by simplified rectangles.
  • the HPT lines 346 for L5 340 and 348 for L4 342 are shown, as is the segmental angle L4-L5 344 according to the HPT method.
  • the Cobb Angle lines 350 for L4 342 and 352 for L5 340 are shown, as is the segmental angle L4-L5 354. The two methods are shown in figure 3C superimposed, for comparison.
  • the HPT line 360 is drawn perpendicular 362 to the Cobb Angle line 364, and the Cobb Angle line 327 is drawn perpendicular 374 to the Cobb Angle Line 364.
  • the HPT line 366 is drawn perpendicular 368 to the Cobb Angle line 370, and the Cobb Angle line 376 is drawn perpendicular 378 to the Cobb Angle line 370. Therefore, the segmental angle 380 formed of the arc between the lines 360 and 366 is equivalent to the segmental angle 382 formed of the arc between the lines 372 and 376.
  • Figure 4A and 4B respectively illustrates two views of an embodiment of the lower body harness 118.
  • the lower body harness 118 is composed of an upper half 405 and a lower half 410.
  • the basic material of the two halves 405 and 410 may be some type of nylon, canvas, Kevlar, cotton, plastic, metal, composite, or any combination of materials that might provide adequate structure and comfort for spinal decompression therapy.
  • the choice of materials should take into account the maximum and typical tensile forces which the lower body harness 118 will relay to the patient 1 10.
  • the upper half 405 of the lower body harness 118 contains six male quick disconnect adapters 412 (three shown on right side of upper half 401).
  • the lower half 410 of the lower body harness 118 contains three female quick disconnect adapters 414 (three shown on right side of lower half 410).
  • the connectors 412 and 414 hold the two halves 405 and 410 together sufficient to withstand the required tensile forces for spinal decompression to occur.
  • the upper half 405 and lower half 410 of the lower body harness 118 are brought together more or less tightly about the patient 1 10 by use of tightening straps 416 fed through all of the male quick disconnect adapters 412. This system allows for adjustment of the lower body harness 118 with respect to patient girth.
  • the upper half 405 of the lower body harness 1 18 contains two recesses 424 and 426 for the right and left legs as they are angled upwards slightly on in the system of Figure 1.
  • the upper half 405 and lower half 410 of figure 4A contain reinforced lower edges 420 and 422, which may consist of additional material sewn or molded about the edge, or may be some form of plastic or metal wire or rod sewn or molded into the material. This reinforced edge may act to grab additionally about the pelvic region to reduce the possibility of slipping.
  • the lower body harness 118 shown mated 430 in figure 4B is designed to comfortably and firmly grab the pelvic region of the patient 110.
  • the pelvis rotate and be encouraged to move away from the head end 104 of the bed 100.
  • the pelvis is encouraged to rotate and move away from the head end 104 of the bed 100, so to will the first sacral vertebra 230 / 310 (SI), S I 230 / 310 being naturally fused to the hip and coccyx.
  • the adapter ring 436 is the point of attachment for the patient interface device 120 of Figure 1, and is of sufficient strength to withstand the requisite forces for spinal decompression.
  • the adapter ring 436 locates the origin of the resultant tension, directed along and carried by the patient interface device 120, at the base of the sacrum.
  • the lower body harness 1 18 moves with SI 230 / 310, and as the location of the adapter ring 436, when acted upon by the resultant tension directed along and carried by the patient interface device 120, causes the lower body harness 118 to rotate upwards and extend away from the head end 104 of the bed 100, so to will SI 230 / 310.
  • Figure 5 illustrates a side view of the system 10 formed by an embodiment of the present invention, detailing the designation of treatment angles.
  • the patient 110 is positioned supine on the bed 100, head on the head end 104 of the bed.
  • the patient's 110 spine 108 is shown over the lordotic support 112, the apex of lordosis L3 250 / 313 over the center- top of the lordotic support 112.
  • the lower body harness 118 is present, as indicated by the vertical and horizontal components 504 and 506, 'x' and 'y' respectively, of the resultant tension vector with origin 502 at the base of the sacrum 230 / 310.
  • the upper body harness 119 is affixed to the head end 104 of the bed 100.
  • the bolster 117 is not shown, however the patient's 110 legs are angled as if over the bolster.
  • L3 250 / 313 acts as the fulcrum 510 for this rotation, as S 1 230 / 310, L5 225 / 311 / 320, and L4 240 / 312 / 322 all reside below L3 250 / 313.
  • L3 250 / 313 acts to oppose the movement of SI 230 / 310 in the vertical direction 'y' 504 as L3 250 / 313 upon the lordotic support 1 12.
  • the hypotenuse 528 is formed of the patient interface device 120 at the point where it exits the tower 130 through slot 145 and the point 510.
  • the treatment angle 538 is equivalent to the angle formed by the HPT lines 235 and 220 formed of the posterior sides of SI 230 / 310 and L5 225 / 31 1 / 320, ( ⁇ - ⁇ 0 )or L5-Sl .
  • the hypotenuse 526 is formed of the patient interface device 120 at the point where it exits the tower 130 through slot 145 and the point 510.
  • the treatment angle 536 is equivalent to the angle formed by the HPT lines 245 / 317 and 235 / 318 formed of the posterior sides of L5 225 / 311 / 320 and L4 240 / 312 / 322, ( ⁇ 2 - ⁇ ) 336 or L4-L5.
  • the entire treatment angle however would consist of ( ⁇ 2 - ⁇ ) 536 + ( ⁇ - ⁇ 0 ) 538.
  • the hypotenuse 524 is formed of the patient interface device 120 at the point where it exits the tower 130 through slot 145 and the point 510.
  • the treatment angle 534 is equivalent to the angle formed by the HPT lines 255 and 245 / 317 formed of the posterior sides of L4 240 / 312 / 322 and L3 250 / 313, ( ⁇ 3 - ⁇ 2 ) or L3-L4. The entire treatment angle however would consist of ( ⁇ 3 - ⁇ 2 ) 534 + ( ⁇ 2 - ⁇ ) 536 + ( ⁇ - ⁇ 0 ) 538.
  • the hypotenuse 522 is formed of the patient interface device 120 at the point where it exits the tower 130 through slot 145 and the point 510.
  • the treatment angle 532 is equivalent to the angle formed by the HPT lines 265 and 255 formed of the posterior sides of L3 250 / 313 and L2 260 / 314, ( ⁇ 4 - ⁇ 3 ) or L2-L3.
  • the entire treatment angle however would consist of ( ⁇ 4 - ⁇ 3 ) 532 + ( ⁇ 3 - ⁇ 2 ) 534 + ( ⁇ 2 - ⁇ ) 536 + ( ⁇ - ⁇ 0 ) 538.
  • the hypotenuse 520 is formed of the patient interface device 120 at the point where it exits the tower 130 through slot 145 and the point 510.
  • the treatment angle 530 is equivalent to the angle formed by the HPT lines 280 and 265 formed of the posterior sides of L2 260 / 315 and LI 270 / 316, ( ⁇ 5 - ⁇ 4 ) or L1-L2.
  • the entire treatment angle however would consist of ( ⁇ 5 - ⁇ 4 ) 530 + ( ⁇ 4 - ⁇ 3 ) 532 + ( ⁇ 3 - ⁇ 2 ) 534 + ( ⁇ 2 - ⁇ ) 536 + ( ⁇ - ⁇ 0 ) 538.
  • the patient interface device 120 and interface positioning device 140 is raised and lowered by the vertical actuator 148 to accommodate the various designated treatment angles 520, 522, 524,526, and 528.
  • the system 10 utilizes passive or absolute encoder, potentiometer, optical distance sensor, or other distance metering feedback to determine vertical position of the patient interface device 120.
  • the bed 100 composed of the base end 106 mattress and head end 104 mattress, is moved together horizontally towards and away from the tower 130 via the horizontal actuator 1 14.
  • the position of the horizontal actuator 114 is known to the system 10 via passive or absolute encoder, potentiometer, optical distance sensor or other distance metering feedback.
  • the vertical position of the patient interface device 120 at the interface positioning device and the horizontal position of the center-top 510 of the lordotic support 112 via the horizontal actuator 114 are known to the system and are used to calculate treatment angle.
  • Figure 6 A and 6B respectively illustrates two overall systems 10, figure 6 A having a head end 104 mattress in a more distal location relative to the tower 130, figure 6B having a head end 104 mattress more proximal to the tower 130.
  • Figure 6A and 6B illustrates geometrically the change in treatment angle ⁇ 2 - ⁇ , 650 - 640 respectively, that occurs when the bed changes position horizontally and the patient interface device 120 at the interface positioning device 140 remains fixed vertically.
  • the head end 104 mattress and base end 106 mattress are fixed in position relative to each other on the bed 100.
  • the center-top 510 of the lordotic support 122 is a distance Hxi 620 away from the tower 130 at the slot 145 which the patient interface device 120 exits the tower 130. This distance is known as the horizontal position of the horizontal actuator's 1 14 connection 116 to the head end 104 mattress is known relative to the distance reported by the distance metering device contained within or without of the horizontal actuator 1 14.
  • the location then of the center-top 510 of the lordotic support 112 is known relative to the position of the horizontal actuator's 114 connection 116 to the head end 104 mattress, as the distance is fixed.
  • the vertical distance Hyi 610 is known, and formed of the end-points made of the intersection of the line 625, which is the tangent line drawn at the center-top 510 of the lordotic support 112 at the tower 130 where the patient interface device 120 exits through the slot 145, which is a fixed point, and of the end-point which is the location at the time of measurement of the patient interface device 120 where it exits the tower 130 at slot 145.
  • the end-point which is the location at the time of measurement of the patient interface device 120 where it exits the tower 130 at slot 145 is known via the vertical actuator's 148 internally or externally mounted passive or absolute encoder, potentiometer, optical distance sensor or other distance metering feedback. Therefore the treatment an le ⁇ 640 is known as:
  • the head end 104 mattress and base end 106 mattress are fixed in position relative to each other on the bed 100.
  • the center-top 510 of the lordotic support 122 is a distance Hx 2 630 away from the tower 130 at the slot 145 which the patient interface device 120 exits the tower 130. This distance is known as the horizontal position of the horizontal actuator's 1 14 connection 116 to the head end 104 mattress is known relative to the distance reported by the distance metering device contained within or without of the horizontal actuator 1 14.
  • the location then of the center-top 510 of the lordotic support 112 is known relative to the position of the horizontal actuator's 114 connection 116 to the head end 104 mattress, as the distance is fixed.
  • the vertical distance Hyi 610 is known, and formed of the end-points made of the intersection of the line 625, which is the tangent line drawn at the center-top 510 of the lordotic support 1 12 at the tower 130 where the patient interface device 120 exits through the slot 145, which is a fixed point, and of the end-point which is the location at the time of measurement of the patient interface device 120 where it exits the tower 130 at slot 145.
  • the end-point which is the location at the time of measurement of the patient interface device 120 where it exits the tower 130 at slot 145 is known via the vertical actuator's 148 internally or externally mounted passive or absolute encoder, potentiometer, optical distance sensor or other distance metering feedback. Therefore the treatment angle ⁇ 2 650 is known as: which translates to:
  • Figure 7A and 7B respectively contains two views of the lower spine, 700 and 701.
  • Figure 7A illustrates the spine before the additional application of resultant tension vector F 702 at treatment angle 790.
  • Figure 7B illustrates the spine after application of said resultant tension F 702.
  • HPT tangent lines 720, 730, 740, 750, 760, and 770 are drawn posterior to the vertebral bodies SI 710, L5 711 , L4 712, L3 713, L2 714, and LI 715.
  • the resultant tension F 702 is applied to the patient 110 via the patient interface device 120 via the lower body harness 118.
  • the lower patient harness 118 is designed to originate the resultant tension vector F 702 at the base of the sacrum 710, underneath the supine patient 110 in this embodiment of the present invention.
  • the resultant tension vector F 702 when broken down into a vertical Fy and horizontal Fx component 704 and 703, acts in two ways on the lower spine 700 / 701.
  • the vertical component Fy 704 can be thought of as lifting, from the sacrum 710, countered by the third vertebra L3 713, the apex of lordosis, upon the center-top 510 of the lordotic support 1 12.
  • the horizontal component Fx 703 can be thought of as pulling through the aligned spinal segments to elongate the spine.
  • the lower spine in figure 7B is acted upon by the resultant 702.
  • the vertebral segment SI 710 is acted upon via the resultant 702 via the lower body harness 118 via the patient interface device 120.
  • the magnitude of the resultant tension 702 is set as a general guideline to 1 ⁇ 2 patient body weight as is customary in the art, however the healthcare provider is responsible for tuning this magnitude sufficient to lift the lower and rotate the lower patient body, sacrum / pelvis / hips, into position.
  • the vertebral segment SI 710 is caused to lift and rotate relative to the inferior endplate of L5 711 per the vertical component Fy 704 of resultant tension 702.
  • the angle of application 790 of resultant tension 702 is ⁇ - ⁇ 0 , 730 - 720, which is sufficient to bring the posterior sides of the vertebral bodies SI 710 and L5 71 1 parallel to each other, and so into 'alignment'.
  • the bringing of into and out of alignment of the vertebral bodies SI 710 and L5 711 results in a confusion and relaxation of paraspinal muscles, especially when resultant tension 702 is cycled smoothly. Additionally, the bringing of into and out of alignment of the vertebral bodies SI 710 and L5 71 1 results in increased imbibition by the intervertebral discs at the end plates of the vertebral bodies, as the process by which imbibition occurs is a mechanical movement of vertebral bodies relative to each other, as described by the bringing into and out of alignment of said bodies. Further, the elongation 780 of aligned vertebral bodies SI 710 and L5 711 results in a drop in interdiscal pressure at the location of elongation, which acts to move nucleosus pulposus through the spine.
  • Figure 8A and 8B respectively contains two views of the lower spine, 800 and 801.
  • Figure 8A illustrates the spine before the additional application of resultant tension vector F 802 at treatment angle 891.
  • Figure 8B is analogous to Figure 7B, rotated by 890 and elongated 880.
  • Figure 8B illustrates the spine after application of said resultant tension F 802.
  • HPT tangent lines 830, 840, 850, 860, and 870 are drawn posterior to the vertebral bodies L5 811, L4 812, L3 813, L2 814, and LI 815.
  • the resultant tension F 802 is applied to the patient 110 via the patient interface device 120 via the lower body harness 118.
  • the lower patient harness 118 is designed to originate the resultant tension vector F 802 at the base of the sacrum 810, underneath the supine patient 110 in this embodiment of the present invention.
  • the resultant tension vector F 802 when broken down into a vertical Fy and horizontal Fx component 804 and 803, acts in two ways on the lower spine 800 / 801.
  • the vertical component Fy 804 can be thought of as lifting, from the sacrum 810, countered by the third vertebra L3 813, the apex of lordosis, upon the center-top 510 of the lordotic support 1 12.
  • the horizontal component Fx 803 can be thought of as pulling through the aligned spinal segments to elongate the spine.
  • the lower spine in figure 8B is acted upon by the resultant 802.
  • the vertebral segments L5 811 and by way of the initial resultant 702 SI 810, are acted upon via the resultant 802 via the lower body harness 118 via the patient interface device 120.
  • the magnitude of the resultant tension 802 is set as a general guideline to 1 ⁇ 2 patient body weight as is customary in the art, however the healthcare provider is responsible for tuning this magnitude sufficient to lift the lower and rotate the lower patient body, sacrum / pelvis / hips, into position.
  • the vertebral segments L5 811 and by way of 702 S I 810, are caused to lift and rotate relative to the inferior endplate of L4 812 per the vertical component Fy 804 of resultant tension 802.
  • the angle of application 891 of resultant tension 802 is ⁇ 2 - ⁇ , 840 - 830, plus that of 790, is sufficient to bring the posterior sides of the vertebral bodies L5 81 1 and L4 812 parallel to each other, and so into 'alignment'.
  • the intervertebral discs are decompressed uniformly 881 and 880, anterior and posterior.
  • Figure 9A and 9B respectively contains two views of the lower spine, 900 and 901.
  • Figure 9A illustrates the spine before the additional application of resultant tension vector F 902 at treatment angle 991.
  • Figure 9A is analogous to figure 8B, rotated by 990 and elongated 980 and 981.
  • Figure 9B illustrates the spine after application of said resultant tension F 902.
  • the HPT tangent lines 940, 950, 960, and 970 are drawn posterior to the vertebral bodies L4 912, L3 913, L2 914, and LI 915.
  • the resultant tension F 902 is applied to the patient 110 via the patient interface device 120 via the lower body harness 118.
  • the lower patient harness 118 is designed to originate the resultant tension vector F 902 at the base of the sacrum 910, underneath the supine patient 110 in this embodiment of the present invention.
  • the resultant tension vector F 902 when broken down into a vertical Fy and horizontal Fx component 904 and 903, acts in two ways on the lower spine 900 / 901.
  • the vertical component Fy 904 can be thought of as lifting, from the sacrum 910, countered by the third vertebra L3 913, the apex of lordosis, upon the center-top 510 of the lordotic support 1 12.
  • the horizontal component Fx 903 can be thought of as pulling through the aligned spinal segments to elongate the spine.
  • the lower spine in figure 9B is acted upon by the resultant 902.
  • the vertebral segments L4 912, and by way of resultant 802 L5 911 , and by way of the initial resultant 702 SI 910, are acted upon via the resultant 902 via the lower body harness 118 via the patient interface device 120.
  • the magnitude of the resultant tension 902 is set as a general guideline to 1 ⁇ 2 patient body weight as is customary in the art, however the healthcare provider is responsible for tuning this magnitude sufficient to lift the lower and rotate the lower patient body, sacrum / pelvis / hips, into position.
  • the vertebral segments L4 912, and by way of resultant 802 L5 911 , and by way of 702 SI 910, are caused to lift and rotate relative to the inferior endplate of L3 913 per the vertical component Fy 904 of resultant tension 902.
  • the angle of application 991 of resultant tension 902 is ⁇ 3 - ⁇ 2 , 950 - 940, plus that of 890 and 790, is sufficient to bring the posterior sides of the vertebral bodies L4 912 and L3 913 parallel to each other, and so into 'alignment'.
  • the intervertebral discs are decompressed uniformly 982 and 981 and 980, anterior and posterior.
  • resultant tension 902 between maximal and minimal levels, the vertebral bodies L3 913 and L4 912, L5 911 and L4 912, and SI 910 and L5 911, are brought into and out of alignment.
  • the benefits of decompressing, 980 and 981 and 982, and bringing into and out of alignment the vertebral bodies have been described in Figure 7.
  • Figure 10A and 10B respectively contains two views of the lower spine, 1000 and 1001.
  • Figure 10A illustrates the spine before the additional application of resultant tension vector F 1002 at treatment angle 1091.
  • Figure 10A is analogous to figure 9B, rotated by 1090 and elongated 1080 and 1081 and 1082.
  • Figure 10B illustrates the spine after application of said resultant tension F 1002.
  • HPT tangent lines 1050, 1060, and 1070 are drawn posterior to the vertebral bodies L3 1013, L2 1014, and LI 1015.
  • the resultant tension F 1002 is applied to the patient 1 10 via the patient interface device 120 via the lower body harness 118.
  • the lower patient harness 118 is designed to originate the resultant tension vector F 1002 at the base of the sacrum 1010, underneath the supine patient 1 10 in this embodiment of the present invention.
  • the resultant tension vector F 1002 when broken down into a vertical Fy and horizontal Fx component 1004 and 1003, acts in two ways on the lower spine 1000 / 1001. In figures 7, 8, and 9, the vertical component Fy 1004 was countered by L3 1013 upon the center- top 510 of the lordotic support 112. As L3 1013 itself is now rotated and lifted, the fulcrum shifts towards L2 1014.
  • the vertical component Fy 1004 can be thought of as lifting, from the sacrum 1010, countered by the second vertebra L2 1014, upon the lordotic support 112.
  • the horizontal component Fx 1003 can be thought of as pulling through the aligned spinal segments to elongate the spine.
  • the lower spine in figure 10B is acted upon by the resultant 1002.
  • the vertebral segments L3 1013, and by way of resultant 902 L4 1012, and by way of resultant 802 L5 1011, and by way of the initial resultant 702 SI 1010, are acted upon via the resultant 1002 via the lower body harness 1 18 via the patient interface device 120.
  • the magnitude of the resultant tension 1002 is set as a general guideline to 1 ⁇ 2 patient body weight as is customary in the art, however the healthcare provider is responsible for tuning this magnitude sufficient to lift the lower and rotate the lower patient body, sacrum / pelvis / hips, into position.
  • the vertebral segments L3 1013, and by way of resultant 902 L4 1012, and by way of resultant 802 L5 101 1, and by way of 702 SI 1010, are caused to lift and rotate relative to the inferior endplate of L2 1014 per the vertical component Fy 1004 of resultant tension 1002.
  • the angle of application 1091 of resultant tension 1002 is ⁇ 4 - ⁇ 3, 1060 - 1050, plus that of 990, 890 and 790, is sufficient to bring the posterior sides of the vertebral bodies L3 1013 and L2 1014 parallel to each other, and so into 'alignment'.
  • the intervertebral discs are decompressed uniformly 1083 and 1082 and 1081 and 1080, anterior and posterior.
  • the vertebral bodies L2 1014 and L3 1013, L3 1013 and L4 1012, L5 101 1 and L4 1012, and SI 1010 and L5 101 are brought into and out of alignment.
  • Figure 11A and 11B respectively contains two views of the lower spine, 1100 and 1101.
  • Figure 11A illustrates the spine before the additional application of resultant tension vector F 1102 at treatment angle 1191.
  • Figure 11A is analogous to figure 10B, rotated by 1 190 and elongated 1180 and 1181 and 1182 and 1183.
  • Figure 11B illustrates the spine after application of said resultant tension F 1102.
  • HPT tangent lines 1160 and 1170 are drawn posterior to the vertebral bodies L2 1114 and LI 11 15.
  • the resultant tension F 1 102 is applied to the patient 1 10 via the patient interface device 120 via the lower body harness 118.
  • the lower patient harness 118 is designed to originate the resultant tension vector F 1102 at the base of the sacrum 1 110, underneath the supine patient 1 10 in this embodiment of the present invention.
  • the resultant tension vector F 1 102 when broken down into a vertical Fy and horizontal Fx component 1104 and 1103, acts in two ways on the lower spine 1100 / 1101.
  • the vertical component Fy 1 104 was countered by L2 1 114 upon the lordotic support 112. As L2 1 114 itself is now rotated and lifted, the fulcrum shifts towards LI 1 115.
  • the vertical component Fy 1 104 can be thought of as lifting, from the sacrum 1 110, countered by the first vertebra LI 1115, upon the lordotic support 112.
  • the horizontal component Fx 1103 can be thought of as pulling through the aligned spinal segments to elongate the spine.
  • L2 1114 and L3 11 13, L3 11 13 and L4 1112, L5 111 1 and L4 1112, and SI 1110 and L5 111 1, are aligned, as described in figure 10B.
  • the segmental angle between LI 11 15 and L2 1114 is not zero (aligned) as the resultant 1002 acting on the spine is at a treatment angle sufficient only to align 11 13 and 11 12, 11 11 and 11 12, and 1 110 and 11 11.
  • the lower spine in figure 11B is acted upon by the resultant 1 102.
  • the vertebral segments L2 1 114, and by way of resultant 1002 L3 1113, and by way of resultant 902 L4 1112, and by way of resultant 802 L5 111 1, and by way of the initial resultant 702 SI 1 110, are acted upon via the resultant 1102 via the lower body harness 118 via the patient interface device 120.
  • the magnitude of the resultant tension 1102 is set as a general guideline to 1 ⁇ 2 patient body weight as is customary in the art, however the healthcare provider is responsible for tuning this magnitude sufficient to lift the lower and rotate the lower patient body, sacrum / pelvis / hips, into position.
  • the vertebral segments L2 1114, and by way of resultant 1002 L3 1113, and by way of resultant 902 L4 11 12, and by way of resultant 802 L5 11 11, and by way of 702 SI 11 10, are caused to lift and rotate relative to the inferior endplate of LI 1 115 per the vertical component Fy 1104 of resultant tension 1102.
  • the angle of application 1191 of resultant tension 1 102 is ⁇ 5 - ⁇ 4, 1170 - 1 160, plus that of 1090, 990, 890 and 790, is sufficient to bring the posterior sides of the vertebral bodies LI 1 115 and L2 1114 parallel to each other, and so into 'alignment'.
  • the intervertebral discs are decompressed uniformly 1184 and 1183 and 1182 and 1181 and 1 180, anterior and posterior.
  • Figure 12 illustrates a flowchart demonstrating an algorithm for calculating treatment angle based on bed position (horizontally towards and away from the tension source) and vertical tension source position, formed according to an embodiment of the present invention.
  • This algorithm begins with the initial starting of the spinal decompression device (step 1200).
  • the vertical linear actuator 148 is resetted to the lowest position; any passive or active encoder data transmitted by distance metering device internally or externally mounted with respect to the vertical linear actuator 148 or the potentiometer data will be measured for this initial zero;
  • the horizontal actuator 1 14 is resetted to the position nearest to the tension-producing actuator 170; any passive or active encoder data transmitted by distance metering device internally or externally mounted with respect to the horizontal linear actuator 1 14 or the potentiometer data will be measured for this initial zero (step 1210).
  • the device calculates the initial treatment angle (step 1220).
  • absolute distance metering device may be used, where this device needs not initialize the vertical and horizontal actuator as described in the step 1210. Preferredly, the device can appoint the latest known position of the vertical linear actuator and the horizontal linear actuator to the nonvolatile memory, thereby the initializing step 1210 is not needed.
  • the system 10 then display the treatment angle (step 1230).
  • the healthcare providers can decide to increase or decrease the treatment angle according to the actual patient condition.
  • the healthcare providers can increase or decrease the treatment angle by pressing the button corresponding to the vertical linear actuator 148 up/down movement (step 1240).
  • any passive or active encoder data transmitted by distance metering device internally or externally mounted with respect to the vertical linear actuator 148 or the potentiometer data will be measured for this initial zero, the encoder pulses will be recalculated (step 1250). At this point, the device recalculates the treatment angle (step 1260). The system 10 displays the changed treatment angle in time (step 1230).
  • the healthcare providers can also increase or decrease the treatment angle by pressing the button corresponding to the horizontal linear actuator 1 14 movement towards or away from the tower (step 1240). If the position of the horizontal linear actuator changes, any passive or active encoder data transmitted by distance metering device internally or externally mounted with respect to the horizontal linear actuator 1 14 or the potentiometer data will be measured for this initial zero (step 1210), the encoder pulses will be recalculated (step 1280). At this point, the device recalculates the treatment angle (step 1290). The system 10 displays the changed treatment angle in time (step 1230).

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  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Pain & Pain Management (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Rehabilitation Therapy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

La présente invention concerne un système permettant de déterminer les angles de traitement d'un dispositif de décompression vertébrale. La présente invention concerne, plus précisément, un dispositif de mise sous traction comprenant un moyen de positionnement du patient conçu pour aligner de façon répétée une zone cible de la colonne vertébrale du patient ; un actionneur assurant ladite mise sous traction conçu pour mettre la colonne vertébrale d'un patient sous traction ; un dispositif de positionnement opérationnellement conçu pour bien positionner l'actionneur assurant la mise sous traction par rapport à la zone cible de la colonne vertébrale du patient ; un dispositif de type interface patient opérationnellement conçu pour assurer l'interface entre l'actionneur assurant la mise sous traction et la colonne vertébrale du patient ; et une unité d'affichage opérationnellement conçue pour fournir des données concernant le vecteur de traction résultant à l'utilisateur ou au professionnel de santé. Ledit dispositif de mise sous traction est opérationnellement conçu pour concentrer la traction au niveau d'un site de traitement de la colonne vertébrale du patient grâce au positionnement géométrique de la colonne vertébrale du patient en respectant la morphologie de la colonne vertébrale et sur la base d'un vecteur de traction.
PCT/CN2012/086601 2011-12-13 2012-12-13 Système de détermination des angles de traitement d'un dispositif de décompression vertébrale Ceased WO2013087019A1 (fr)

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CN201110415613.8A CN103156754B (zh) 2011-12-13 2011-12-13 用于确定脊柱减压设备治疗角度的系统
CN201110415613.8 2011-12-13

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EP2790616A4 (fr) * 2011-12-13 2015-12-16 Beijing Ryzur Axiom Medical Invest Co Ltd Système d'ajustement dynamique de l'angle de traitement sous traction permettant de s'adapter aux variations de la morphologie rachidienne
CN113499180A (zh) * 2021-06-25 2021-10-15 西安交通大学 一种脊柱侧凸矫形器及其制造方法
CN115462940A (zh) * 2022-08-18 2022-12-13 北京机械设备研究所 一种电动牵引装置

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US20060287627A1 (en) * 2005-06-16 2006-12-21 Axiom Worldwide, Inc. System and method for patient specific spinal therapy
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CN113499180A (zh) * 2021-06-25 2021-10-15 西安交通大学 一种脊柱侧凸矫形器及其制造方法
CN115462940A (zh) * 2022-08-18 2022-12-13 北京机械设备研究所 一种电动牵引装置

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