Abstract:
Systems, devices, and methods for diagnosing and treating conditions of the spine employ a garment for selectively positioning vertebrae of a spine of a supine individual, e.g., during diagnostic imaging of the spine. The garment affects movement of vertebrae that can be diagnostically correlated with incidents of back pain.

Description:
FIELD OF THE INVENTION 
     The invention generally relates to systems, devices, and methods for diagnosing and treating conditions of the spine, including systems, devices, and methods for positioning the spine while obtaining diagnostic images. 
     BACKGROUND OF THE INVENTION 
     Many different conditions may cause back pain. Doctors can use several tests to visualize the spine to get an idea of what might be causing the back pain. The imaging diagnostic procedures that are currently used to image the spine include plain x-rays, myelograms, bending X-rays, PET scans, CT scans, CT myelograms, MRI scans, MRI&#39;s with contrast, and discograms. 
     No single test is perfect in that it identifies the absence or presence of disease 100% of the time. The problem exists that it is not always possible to obtain a correct diagnosis of the cause of a patient&#39;s back pain through state of the art imaging. 
     SUMMARY OF THE INVENTION 
     The inventor has discovered that part of the failure to diagnose back pain through imaging is that, when the imaging study is performed, the patient is typically in a position in which there is no back pain. Thus, whatever is causing the patient&#39;s back pain will not be observed. 
     The present invention overcomes this problem. The invention makes possible precise positional adjustments to the patient&#39;s spine and pelvic bones during imaging to move the patient spine into a position that causes pain. The spine position and the incidence of pain can be correlated to yield a diagnosis as to the underlying cause of the back pain. 
     The invention provides systems, devices, and methods for diagnosing back pain that include a garment for selectively positioning vertebrae of a spine of a supine individual during diagnostic imaging of the spine. The garment affects movement of vertebrae that can be diagnostically imaged and correlated with incidents of back pain. 
     The garment can also be used as a diagnostic tool in and of itself, without the use of imaging. 
     Other objects, advantages, and embodiments of the invention are set forth in part in the description which follows, and in part, will be obvious from this description, or may be learned from the practice of the invention. 
    
    
     
       DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is an anatomic view of a human spine, showing the cervical, thoracic, lumbar, and sacral regions of vertebrae. 
         FIG. 2  shows the spine in conditions of extension and flexion. 
         FIG. 3A  is a front view of a garment for selectively positioning vertebrae of a spine of a supine individual during diagnostic imaging of the spine by affecting movement of vertebrae that can be diagnostically imaged and correlated with back pain, the garment being shown in a closed position. 
         FIGS. 3B and 3C  are front views of the garment shown in  FIG. 3A , with the garment partially and fully opened, respectively,  FIG. 3C  further showing a series of expandable segments within the garment that are precisely positioned to align, when the garment is worn, with groups of vertebrae or individual vertebrae along the thoracic, lumbar, and sacral regions of the spine, as well as with pelvic bones affecting the sacroiliac joint. 
         FIGS. 3D and 3E  are alternative views of the garment in a fully opened condition, showing alternative arrangements of the series of expandable segments within the garment that are precisely positioned to align, when the garment is worn, with groups of vertebrae or individual vertebrae along the thoracic, lumbar, and sacral regions of the spine, as well as with pelvic bones affecting the sacroiliac joint. 
         FIGS. 4A and 4B  are, respectively, front and side views of the garment shown in  FIG. 3A  when worn by an individual. 
         FIG. 4C  is a front view of the garment shown in  FIG. 3A , when in an open condition (as shown in  FIG. 3C ), further showing an undergarment that can be worn underneath the garment during use. 
         FIG. 5  is a view of the individual shown in  FIG. 4A  wearing the garment laying supine on a table in an imaging field. 
         FIG. 6  is a side section view of the individual shown in  FIG. 5 , showing the alignment of the expandable sections with groups of vertebrae or individual vertebrae along the thoracic, lumbar, and sacral regions of the spine, as well as with pelvic bones affecting the sacroiliac joint, the expandable sections being in a normal collapsed, and not enlarged, condition. 
         FIG. 7  is a side section view of the individual, like that shown in  FIG. 6 , but with all the expandable sections enlarged by fluid pressure to press against the vertebrae to affect movement of the vertebrae so that movement of the vertebrae can be diagnostically imaged. 
         FIG. 8  is a side section view of the individual shown in  FIG. 5 , showing the selective enlargement of the expandable sections by fluid pressure along the thoracic and sacral regions to simulate flexion of the spine during diagnostic imaging. 
         FIG. 9  is a side section view of the individual shown in  FIG. 5 , showing the selective enlargement of the expandable sections by fluid pressure along the lumbar region to simulate extension of the spine during diagnostic imaging. 
         FIGS. 10 and 11  are, respectively, a side section view and a transverse section view of the individual shown in  FIG. 5 , showing the selective enlargement of the expandable sections over opposite lateral sides of the anterior superior iliac spine (ASIS) to affect bone movement along the sacroiliac joint. 
         FIG. 12  is a front view of the individual shown in  FIG. 4A , showing in greater detail the location of the expandable sections over opposite lateral sides of the anterior superior iliac spine (ASIS) to affect bone movement along the sacroiliac joint. 
         FIG. 13  is a side section view of the individual shown in  FIG. 5 , showing mechanical actuators carried within the expandable sections, and further showing the selective enlargement of the expandable sections by the mechanical actuators in the lumbar region to simulate extension of the spine during diagnostic imaging. 
         FIG. 14  is a front view of a garment of the type shown in  FIG. 3A , with the garment fully opened, to show a series of expandable segments within the garment that are precisely positioned to align, when the garment is worn, with groups of vertebrae or individual vertebrae along the thoracic, lumbar, and sacral regions of the spine, the expandable segments being partitioned into individual left and right expandable chambers that can be independent enlarged on each vertebral level. 
     
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT 
     A. The Spine 
       FIG. 1  shows a human spinal column, also called the spine, or backbone. The spine is a flexible column extending from neck to pelvis, made of a series of bones, called the vertebrae. The major function of the spine is protection of the spinal cord. It also provides stiffening for the body and attachment for the pectoral and pelvic girdles and many muscles. In humans, an additional function is to transmit body weight during walking and standing. 
     In humans (and other mammals), the spine includes four main regions: (1) the cervical, in the neck, with articulates with the head; (2) the thoracic, in the chest, which articulates with the ribs; (3) the lumbar, in the lower back, which articulates with bending and stretching; and (4) the sacrum, which articulates with the pelvic girdle at the sacroiliac joint. 
     As shown in  FIG. 1 , humans have 7 cervical vertebrae (numbered C1 to C7), 12 thoracic vertebrae (numbered T-1 to T-12), five 5 lumbar vertebrae (numbered L-1 to L-5), and 5 fused sacral vertebrae. 
     As shown in  FIG. 2 , when an individual bends backward, the spine is said to be in “extension.” When an individual bends forward, the spine is said to be in “flexion.” Depending on the source of the back pain, back pain can occur during extension, or during flexion, or during both. 
     B. The Garment 
       FIGS. 3A to 3E  and  4 A to  4 C show a garment  10  that embodies features of the invention. The garment  10  is made of durable fabric, rubber, or synthetic material (e.g., canvas or wet suit material) and is sized and configured to be worn by an individual. The material of the garment  10  is substantially transparent to the imaging energy; that is, it does not substantially interfere with the diagnostic imaging. 
     As shown in  FIG. 3A , the garment  10  includes a vest region  12 , with arm and neck openings  14  and  16 , so that the vest region  12  can be comfortable worn on the upper torso, as  FIGS. 4A and 4B  show. 
     As shown in  FIG. 3A , the garment  10  also desirably includes a pantaloon region  18 , with leg openings  20 , so that the pantaloon region  18  can be worn about the waist and hips like trousers, as  FIGS. 4A and 4B  show. In an alternative embodiment, the garment  10  can include only a vest region  12 , with no pantaloon region  18 . 
     In the illustrated embodiment, see  FIGS. 3B ,  3 C, and  4 C, the vest region  12  includes overlapping left and right flaps  22  and  24  that open to allow a person to put the vest region  12  and pantaloon region  18  on. The left and right flaps  22  and  24  close in an overlapping condition (shown in  FIG. 3A ) to secure the vest region  12  on the upper torso and the pantaloon region  18  on the hips and waist (see  FIGS. 4A and 4B  show). A closure mechanism  26  is carried by one or both of the flaps  22  and  24  to releasably hold the flaps  22  and  24  in a closed condition. The closure mechanism  26  can comprise, e.g., VELCRO® material, plastic buttons, plastic hooks, or plastic snaps, made of materials which do not interfere with the imaging. 
     As shown in  FIG. 4C , a disposable or nondisposable (but washable) inner garment  28  can be provided. The inner garment  28  keeps the main outer garment  10  from coming into direct contact with the skin of a patient, so the outer garment  10  can be used by multiple patients undergoing imaging. Like the garment  10  itself, the inner garment  28  is substantially transparent to the imaging energy so that it does not substantially interfere with the diagnostic imaging. 
     As shown in  FIG. 3C , the garment  10  includes a series of expandable segments  30 . The expandable segments  30  are precisely positioned to align, when the garment  10  is worn, with groups of vertebrae or individual vertebrae along the thoracic, lumbar, and sacral regions of the spine, as well as with pelvic bones affecting the sacroiliac joint, as  FIG. 6  shows. 
     The expandable segments  30  are made from material that assumes a normal lay-flat condition, as  FIG. 5  shows, but can be enlarged or expanded into an enlarged condition that preferentially presses against the adjoining vertebrae. The material of the garment  10  is less flexible that the material of the expandable segments  30 , so that, during enlargement, the expandable segments  30  expand preferentially inward into the interior of the garment  10 . By pressing against the vertebrae, the expandable segments preferentially move alter the position of the vertebrae, muscles, and nerves to simulate extension and/or flexion and/or other orientation of the spine and pelvic region while the patient otherwise lays supine for imaging, as  FIGS. 5 and 7  show. 
     The expandable segments  30  are made from a material that is substantially transparent to the imaging energy, so that it does not substantially interfere with the diagnostic imaging. 
     To affect preferential enlargement the expandable segments  30 , the garment  10  further includes an array of actuators  32  that form or are otherwise carried within the expandable segments  30 . The actuators  32  comprise structures that can be controllably enlarged, either by conveyance of liquid or air (either of which can be called a “fluid”) or by mechanical means, from a normal collapsed condition to an enlarged, expanded condition. It is by operation of the actuators  30  that the expandable segments  30  enlarge to preferentially press against adjacent vertebrae or pelvic bone of the individual wearing the garment  10 , moving and orientating vertebrae, muscles, and nerves of the spine. The actuators  32  are made from a material or materials that is/are substantially transparent to the imaging energy, so that the actuators  32  do not substantially interfere with the diagnostic imaging. 
     While the individual wearing the garment  10  lays supine to undergo imaging (as  FIGS. 5 ,  6 , and  7  show), the actuators  32  are operated to apply coordinated external pressure to the vertebrae in regions of the spine. Operation of the actuators  32  affects predictable movements of the spine in desired directions, while imaging occurs, with the objective to cause an incident of back pain that can be coordinated with spine orientation and thereby lead to a diagnosis of the source of the back pain. That is, the incident of back pain can be correlated to an orientation of the spine that is captured by the imaging at the time the pain occurs. In this way, the orientation and motion of the spine that causes back pain can be systematically simulated and examined, to identify the particular bone or bones which are being moved to cause the back pain. 
     The size and configuration of the expandable segments  30  can vary. In a representative embodiment shown in  FIG. 3C , a single, axially elongated expandable segment for the substantially the entire thoracic region is shown, e.g., extending generally from T1 to T11 and measuring, e.g., about 5 to 8 inches wide transverse the axis of the spine and about 20 inches+/−5 inches axially along the axis of the spine. Also, in the representative embodiment shown  FIG. 3C , there are a plurality of individual expandable segments  30  in the lumbar region, e.g., extending generally from T12 to T5 and each expandable segment  30  measuring, e.g., about 5 to 8 inches wide transverse the axis of the spine and about 1 to 2 inches along the axis of the spine. In the representative embodiment shown  FIG. 3C , there is a single expandable segment for substantially the entire sacral region, measuring about half the size of the expandable segment in the thoracic region. In  FIG. 3C , there are also expandable segments  30  carried on the front of the garment  10 , in the pantaloon region  18 , that register over opposite lateral sides of the anterior superior iliac spine (ASIS) to affect bone movement along the sacroiliac joint. This is also shown in  FIG. 12 . 
       FIGS. 3D and 3E  show alternative different illustrative configurations. In  FIG. 3D , there are two expandable segments  30  in the thoracic region. In  FIG. 3E , there are separate expandable segments  30  for each vertebra in the thoracic and lumbar regions. 
     The actuators  32  also may take various forms and configuration, depending upon the size and configuration of the expandable segments  30 . In the illustrated embodiment of  FIGS. 3C ,  3 D, and  3 E, the actuators take the form of inflatable bodies that form or are carried within the expandable segments  30 . The expandable bodies can comprise, e.g., balloons made from elastic, non-elastic, or semi-elastic materials. Tubing  40  individually couples each expandable body to a source of expansion air or (desirably) liquid (see  FIG. 5 ) that does not degrade the actuator or interfere with imaging, so that each expandable body can be selectively enlarged or collapsed in a controlled manner by the caregiver, as desired, see  FIGS. 6 and 7  show. 
     Alternatively, as shown in  FIG. 13 , the actuators  32  can take the form of mechanical jack type lifters or small elevators  34  that are carried within the expandable segments  30 . The mechanical actuators  34  can selectively and individually be operated to achieve the desired results, as just described. 
     In an alternative embodiment (see  FIG. 14 ), the actuators  32  can be sized and configured to enlarge more on one lateral side (left or right) of a vertebral level than another. For example, the balloons  30  at one or more vertebral levels can be formed to preferentially expand more on one lateral side than other, e.g., by the inclusion of individual right and left lateral size chambers  40  and  42  separated by a septum  44 . The chambers  40  and  42  are coupled to individual inflation tubing. Inflation of only a right side chamber  40  (and not the left side chamber  42 )—or vice versa—press against only the affected side of the adjacent vertebrae of the individual wearing the garment  10 . Thus, more precise and preferential ranges of movement can be provided to lead to greater degrees diagnostic accuracy. 
     C. Use of the Garment 
     For example, as shown in  FIGS. 5 and 6 , the individual wearing the garment  10  lays supine on an imaging table  36  in an imaging field  38 . Once the individual is positioned for imaging, expandable segments of the garment can be systematically and preferentially enlarged to affect movement of adjacent vertebra. In  FIG. 7 , all of the expandable segments  30  in the thoracic, lumbar, and sacral regions are enlarged for the purpose of illustration. However, selective groups of some expandable segments  30  can be enlarged, without enlarging other selective groups of the expandable segments  30 . 
     For example, in  FIG. 8 , only the expandable segments  30  for the thoracic and sacral regions are selectively enlarged (the expandable segments  30  in the lumbar region not being enlarged), to determine what effect simulated flexion may have on back pain and the spine. Or, as shown in  FIG. 9 , only the expandable segments  30  in the lumbar region can be selectively enlarged (the expandable segments  30  for the thoracic and sacral regions not being enlarged), to determine what effect extension may have on back pain and the spine. To test the sacroiliac joint (as  FIGS. 10 and 11  show), both expandable segments  30  on the ASIS can be enlarged, along with the expandable segment for the sacral region (if desired), to stress the sacroiliac joint from two directions. 
     Once an incident of back pain is generated, the incident of pain can be correlated to the orientation of the spine that is captured by the imaging at the time the pain occurs. In this way, the orientation and motion of the spine that causes back pain can be systematically simulated and examined, to identify which movement of particular bone or bones, or which orientation of the spine, causes the back pain. 
     The garment  10  can also be used as a diagnostic tool in and of itself, without the use of imaging. For example, by enlarging both expandable segments  30  on the ASIS along with the expandable segment  30  for the sacral region, the sacroiliac joint can be stressed from two directions. If the sacroiliac joint is a pain generator when stressed in this manner, this alone can serve as a diagnosis of dysfunction at the sacroiliac joint. 
     Other embodiments and uses of the inventions described herein will be apparent to those skilled in the art from consideration of the specification and practice of the inventions disclosed. All documents referenced herein are specifically and entirely incorporated by reference. The specification should be considered exemplary only with the true scope and spirit of the invention indicated by the following claims. As will be easily understood by those of ordinary skill in the art, variations and modifications of each of the disclosed embodiments can be easily made within the scope of this invention as defined by the following claims.