Abstract:
A system and a method for the relief of pain/irritation of the spine or for the prevention of degeneration of the spine. The system is designed to facilitate creep in the human spine in a way that can be self-administered and with which patients will readily comply. The apparatus comprises a base, an inclinable support surface pivotably connected to the base, said support surface capable of supporting the upper body of the person in a prone position, a support member coupled to the base and the support surface, and an actuator coupled to the support member for controlling the angle of inclination of the support surface to promote distraction of the spine. The method comprises positioning a person on the support surface and adjusting the angle of inclination thereof so that the device supports the upper body of the person and gravity causes distraction of the spine.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]     The present application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Application No. 60/595695 filed Jul. 28, 2005 and entitled “Spine Irritation Relief Apparatus”, which is hereby incorporated herein by reference for all purposes. 
     
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT  
       [0002]     Not Applicable  
       Field of the Invention  
       [0003]     The present invention relates generally to an apparatus and method for relieving irritation of the spine and the avoidance and/or reversal of spine degenerations  
       BACKGROUND OF THE INVENTION  
       [0004]     Back pain is an enormous burden to society, with almost 80 percent of people suffering from back pain at some point in their lives. Back pain accounts for more lost work days than any other medical condition and it is estimated that the incremental cost of back pain to society was almost $27 billion in 2002. The incidence and impact of back pain in children and young adults is also increasing.  
         [0005]     Reducing the impact of back pain on society has proven elusive. By way of illustration, a Medline search for the phrase “low back pain” results in over 10,000 references from 1950 to the present, and addition of the term “treatment” reduces this number to 6,461. Despite these thousands of research studies that may be addressing the problem of back pain, there is little clear evidence that the typical back pain patient is likely to fare any better today than they would have if they were treated a decade or more ago. The only evidence of a global change in the impact of back pain to society was in an NIH (National Institutes of Health) progress report suggesting that activity limitations due to chronic back pain have declined from 32 to 26 percent from 1997 to 2002, although an explanation for this apparent decline was not provided (based on data from the National Health Interview Survey of the CDC, as reported in the 2002 progress report for the Healthy People 2010 program of the Department of Health and Human Services, DHHS). The DHHS has included reducing the cost of back pain as a specific objective in their Healthy People 2010 program, although since this program was started in 2000, no major milestones have been reported.  
         [0006]     There are now many different surgical and non-surgical treatments that are offered to patients with back pain and related symptoms. There are many more treatments that are in development or clinical trials. The existing scientific evidence suggests that many of the surgical treatment options can provide some benefit to some patients. However, it is also clear that improperly selected patients will do worse with many of these treatments. Unfortunately, validated patient selection guidelines that are proven to be reliable and efficacious are not available for any current surgical option. For this reason, and because the least invasive treatment is, in most instances, preferable for patients, non-surgical treatment options are almost always the first line of treatment for patients with low back pain.  
         [0007]     There exist many non-surgical treatment options for patients experiencing back pain. Avoiding certain activities and using mild anti-inflammatory and pain medication is frequently the first treatment offered. Physical therapy, massage, chiropractic manipulations, and heat or cold therapy are other commonly offered treatments, although systematic reviews of many of these options have generally concluded that most of these treatments are not based on rigorous scientific evidence. Numerous treatment guidelines have also been published, but the scientific basis for many of these guidelines is poor, and the clinical efficacy of the guidelines has never been established.  
         [0008]     During the degenerative process that occurs in the lower spine of many people as they age and accumulate mechanical damage to the spine, the intervertebral discs lose height and elasticity. The discs are thereby less able to absorb the mechanical loads that occur during activities of daily living. In addition, loss of disc height is associated with an increasing percent of loads being transferred through the facet joints. As the facet joints support higher loads, the cartilage degrades and osteophytes begin to form around the periphery of the joints. In addition, osteophytes can form along the edges on the endplates of the vertebrae. The loss of disc height and the concomitant enlargement of the facets and endplates together reduce the amount of space available for the blood vessels and nerve tissue that passes through the spinal canal and the neural foramen. This is believed to result in mechanical irritation of the nerve and vascular structures. Numerous studies have shown that mechanical compression of nerve roots, particularly if the regional tissue is inflamed, results in pain. It is also well-known that surgical decompression of the spinal canal and neural foramen will alleviate symptoms in many patients. These surgical decompression procedures are, however, not without complications. A non-surgical method for decompressing the spinal canal and nerve roots may similarly provide relief of back pain and related symptoms.  
         [0009]     It is known that the intervertebral discs increase in height after sleep. Multiple studies have demonstrated that unloading the spine can increase disc height and improve the mechanical behavior of the spine. The mechanism by which the spine changes during periods of relatively low loading is complex, but is known to involve the process of mechanical creep. Mechanical creep is the elongation that occurs over time in a material or structure when subject to a constant sustained load. This process of creep can be facilitated by subjecting the spine to periods of low loads, but even more so with application of a sustained distractive load. Subjecting the spine to distractive loads over an extended period of time, and doing this frequently enough to encourage healing and perhaps regeneration of any inflamed or damaged tissues in and around the spine is challenging.  
       SUMMARY OF THE INVENTION  
       [0010]     A specially designed mechanical system and method of using said system has been developed to treat and prevent recurrence of lower back pain and related symptoms. The system is designed to facilitate creep in the human spine in a way that can be self-administered and with which patients will readily comply. This system consists of a soft surface, designed to hold a person in a prone position on an incline that is very comfortable and prevents the upper body from slipping down the inclined surface. In this disclosure, “prone” is used to imply a position with the front of the body turned toward the supporting surface. The supporting surface may be inclined or fully horizontal, but the word “prone” as used herein does not require that the body be fully horizontal.  
         [0011]     The intention of the system is to relax the body and allow gravitational forces to create distraction on the lumbar spine through the weight of the lower body, causing the lower body to slide down the inclined surface away from the upper body, which is prevented from sliding down the surface. Preliminary studies show that this action facilitates mechanical creep in the ligaments, intervertebral disc and muscles spanning between vertebrae. The desire is to increase the height, hydration, and nutrition of the tissues within the intervertebral disc and facet joints, and also to increase the volume available for the containment of the nerves and vascular components within the spinal canal and neural foramen. Maintaining the body on an inclined surface may also allow for drainage of venous blood from bone and tissues that comprise the spine, and this may also reduce excitation of pain sensing nerves within the bone and tissues of the spine.  
         [0012]     Since the hypothesized mechanisms and intended goals of this system likely require that the patient spend an hour or more lying continuously on the inclined surface, in order to give the spine time to heal, the surface is also designed to allow patients to work on a computer, read, watch television, listen to music, attend meetings, talk on a telephone, and otherwise distract themselves while also beneficially distracting their spine.  
         [0013]     In addition to positioning a person in a way that can facilitate healing of tissues that are causing back related symptoms, there is also scientific evidence supporting that the described invention may also help prevent or reverse degenerative changes in the spine. Therefore, the described invention may not only be useful to people presenting with back-related symptoms, it may also be of value to people who would like to avoid degenerative changes in the spine.  
         [0014]     This apparatus could be used in private homes, public venues, such as theaters, coffee houses, etc., and may even prove valuable as an operating table.  
         [0015]     Disclosed herein is an apparatus comprising a base, an inclinable support surface pivotably connected to said base, said support surface capable of supporting the upper body of the person in a prone position, a support member coupled to said base and said support surface, and an actuator coupled to said support member operable for controlling the angle of inclination of said support surface.  
         [0016]     In an embodiment the apparatus comprises a lower body support surface and a torso immobilizer coupled to the support surface to secure the upper body of a person on the support surface when the support surface is tilted up or down. In an embodiment, the torso immobilizer has an open position and a closed position and encloses at least a portion of the upper body of a person when the torso immobilizer is in the closed position. In an embodiment, the torso immobilizer comprises a pivoted rigid support structure comprising a pair of arms, armpit supports attached to the pivoted rigid support structure, and a torso contact surface attached to the pivoted rigid support structure.  
         [0017]     In an embodiment, the support surface of the apparatus is a contoured support surface. In an embodiment, the support surface of the apparatus is a contoured support surface that is contoured to accommodate the body shape of the person. In an embodiment, the support surface of the apparatus is a contoured support surface that is custom-made to accommodate the body shape of the person.  
         [0018]     Also disclosed herein is a method for relieving and preventing irritation to the spine of a person. The method comprises (a) providing an apparatus having an inclinable support surface adapted for supporting the body of a person in a prone position and an actuator that controls the angle of inclination of the support surface; (b) positioning the person on the support surface, wherein the torso and at least a portion of the lower body of the person are supported by the support surface and (c) adjusting the angle of inclination of said support surface after positioning said person on said support so that there is adequate distraction of the spine.  
         [0019]     The present invention comprises a combination of features and advantages which enable it to overcome various problems of prior devices and methods. The various characteristics described above, as well as other features, will be readily apparent to those skilled in the art upon reading the following detailed description of the preferred embodiments of the invention, and by referring to the accompanying drawings.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0020]     For a more detailed description of the preferred embodiment of the present invention, reference will now be made to the accompanying drawings, wherein:  
         [0021]      FIG. 1  is a side view of a spine distraction device constructed in accordance with a first embodiment of the present invention;  
         [0022]      FIG. 2  is a side view of a person engaging the device of  FIG. 1 ;  
         [0023]      FIG. 3  is a side view of a person engaging the device of  FIG. 1  and having assumed a partially prostrate position; and  
         [0024]      FIG. 4  is a front view of the device of  FIG. 1 ;  
         [0025]      FIG. 5  is a side view of a person engaging a device constructed in accordance with a second embodiment of the present invention;  
         [0026]      FIG. 6  is a front view of the device of  FIG. 5 ;  
         [0027]      FIG. 7  is a schematic cross-section illustrating the operation of the torso support member the device of  FIG. 5 ;  
         [0028]      FIG. 8  is a partial side showing a person engaging the head support of a third embodiment of the present invention; and  
         [0029]      FIG. 9  is an enlarged partial view illustrating one embodiment of a connection for the head support of  FIG. 8 . 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0030]     In the embodiment shown in  FIGS. 1-4 , a spine irritation relief apparatus (SIRA)  10  comprises a base  20 , a support member  25 , a body support  40  having a support surface  42 , lower surface  45 , and an actuator  30  coupled to support member  25  and base  20 . In the embodiments shown in  FIGS. 1-4 , SIRA  10  comprises a foot support  60 , a pair of hand grips  65 , a peripheral support  70 , a head support  80 , and a controller  90 . In this embodiment, support surface  42  is a contoured support surface. Lower surface  45  and contoured support surface  42  may or may not be a single unit. Other embodiments of the present invention may not incorporate all of the above-mentioned features.  
         [0031]     As shown in  FIG. 2 , a person  50  preferably first engages SIRA  10  when contoured support surface  40  is in a near-vertical position. Person  50  can use foot support  60  and/or hand grips  65  to help position him- or herself relative to contoured support surface  40 . After such positioning, person  50  leans forward so that contoured support surface  40  contacts the front of person  50 . Person  50  may then use controller  90  to control actuator  30 , causing support member  25  to retract, thereby changing the position of body support  40 . Actuator  30  may be an electric, hydraulic, or other type of actuator suitable for controlled movement. By changing the position of support member  25 , body support surface  40  can be rotated to a more or less prostrate position, as shown in  FIGS. 2 and 3 . In an alternative method of use, person  50  can use controller  90  to rotate body support  40  to a more horizontal position than that shown in  FIG. 2  before engaging the device. This method may be particularly preferred in embodiments of the present invention that do not comprise a foot support  60  or hand grips  65 .  
         [0032]     In  FIG. 3 , person  50  has used controller  90  and actuator  30  to rotate body support  40  so that the angle between support  40  and horizontal is decreased. However, as shown in  FIG. 3 , support  40  is still somewhat inclined with respect to horizontal. Many users of the device will find that an angle of twenty-five to forty-five degrees from horizontal provides an optimal effect. This allows the weight of the lower body of person  50  to create tensile forces on the spine of person  50 . If necessary, the position of foot support  60  may be adjusted or automatically shifted in certain embodiments so that the weight of the lower body is not supported by foot support  60  after contoured support surface  40  has been rotated. As the spine of person  50  is subjected to tensile forces, mechanical creep is induced in the spine, which can relieve irritation and reduce pain associated with the spine and help prevent or reverse degeneration of the spine.  
         [0033]     In  FIG. 4 , a front view of one embodiment of SIRA  10  is shown. From this view, the head support  80 , peripheral support  70 , hand grips  65 , and foot support  60  can be more clearly seen. As shown, hand grips  65  and foot support  60  can be used to allow a person to easily position him or herself in front of body support  40 . Head support  80  allows person  50  to comfortably rest his or her head so that person  50  may comfortably use SIRA  10  for extended periods of time. Peripheral support  70  can include attachments that allow it to support numerous devices, such as a telephone, a book, a keyboard, a computer mouse, a computer display, a television screen, a workspace, a writing surface, a controller for an entertainment system, a drink holder, a food tray, or other devices (not shown). The ability to access such peripheral devices allows person  50  to remain productive and engage in other activities while using SIRA  10 . This increases the likelihood that person  50  will use SIRA  10  for an extended period of time, and therefore will increase the chances that SIRA  10  will provide effective relief to and prevent degeneration of the spine of person  50 .  
         [0034]     Referring back to  FIG. 3 , it can be seen that the contoured support surface  42  provides a comfortable surface upon which person  50  lies while using SIRA  10 . Contoured support surface  42  can be designed to specifically match the dimensions of a particular person  50 . This can be accomplished in various methods, such as laser scanning the front surface of person  50  and manufacturing contoured support surface  42  based on the dimensions obtained from the scan. Other methods of manufacture may include techniques such as impression molding, in which person  50  lies on a soft material that can be used to create a mold for contoured support surface  42 . In addition, a different contoured support surface  42  can be designed to accommodate either men or women or can be designed for a range of differently-sized persons  50 . In an embodiment, the contoured support surface may be interchangeably connected to the base to allow a person to use a contoured support surface designed for his body.  
         [0035]     In addition to increasing the comfort of person  50 , contoured support surface  40  also helps prevent the upper body of person  50  from sliding down while the device is in use. In certain embodiments, surface  42  is covered with a material selected such that the coefficient of friction between contoured support surface  42  and natural fiber clothing is greater than 0.6. In other embodiments, the contoured support surface  42  may have different coefficients of friction in the portions which support the upper torso and the lower body. For example, the coefficient of friction in the upper portion may be higher than the coefficient of friction in the lower portion, allowing the lower portion to subject the spine of person  50  to an increased tensile load. As shown in  FIG. 3 , when the lower body follows the contours of contoured support member  40 , it causes the back of person  50  to be extended or stretched. In the embodiment of  FIG. 3 , controller  90  can be connected to the peripheral support  70 . This allows person  50  to easily access controller  90  and adjust the angle of contoured support member  40  to the desired position.  
         [0036]     As shown in  FIGS. 5-8 , a second embodiment of the present invention incorporates a collapsible hammock-type torso immobilizer  100 . As shown in  FIG. 5 , this embodiment includes a base  20 , support member  25 , body support  40 , hammock-type or upholstered (not shown) lower body supports  120 , upper body support member  45 , lower body support member  47 , an actuator  30  coupled to support member  25  and base  20 , hand grips  65 , peripheral support  70 , head support  80 , controller  90 , torso immobilizer  100 , a pivots  35  for adjusting the relative positions of upper body support member  45  and lower body support member  47 , and pivot(s)  75  for adjusting the position of peripheral device  70 . Other embodiments of the present invention may not incorporate all of the above-mentioned features.  
         [0037]     In this second embodiment, the upper body is held against the apparatus  10  through the use of torso immobilizer  100 , which is shown in more detail in  FIGS. 6 and 7 . Torso immobilizer  100  preferably includes a mesh hammock-type inner support layer  101 , armpit supports  102 , rigid peripheral support structure  103 , pivots  104 , and at least one elastic strap  105 . As seen in  FIG. 7 , the rigid support structure  103  includes a pair of arms  106  that each pivot around a respective pivot  104 , as indicated by arrow  107 . The lower portion of each arm  106  curves away from the pivot point  104  and at its remote end is retained by elastic strap  105 . Thus, elastic strap  105  tends to urge the lower ends of the arms together, which in turn causes the upper ends of the arms to open. It will be understood that elastic strap  105  can be replaced with any other suitable biasing means. When the device is not in use, the torso immobilizer is held open by this mechanism, making it easy for a user to enter and engage the device.  
         [0038]     As best seen in  FIG. 6 , a mesh or netting  101  extends between the upper portions of arms  106 . Mesh  101  is preferably but not necessarily an open-weave mesh that is at least somewhat elastic. When the device is in use, the weight of the user tends to bring the upper ends of arms  106  together, against the biasing action of elastic means  105 . As arms  106  come together, mesh  101  partially encircles the torso of the user, as shown in  FIG. 7 . This results in a comfortable and secure support of the user&#39;s body.  
         [0039]     Armpit supports  102  (most clearly seen in  FIGS. 5 and 6 ) preferably comprises a fabric-wrapped foam that is designed to comfortably support the armpits of person  50  when they are supported in the device. Optional hand grips  65  may be, for example, plastic and may be attached to the foam of the armpit support  102  or, alternatively, to the lower surface  45  of the apparatus  10 . Likewise, a head support  80  may extend from upper body support member  45  or another part of the device.  
         [0040]     In the embodiment of  FIGS. 5-7 , a person  50  advances to the apparatus  10  when it is in an upright or nearly upright position, places his arms over the contoured armpit support  102  and, by bending his arms, optionally grasps hand grips  65 . Using controller  90 , which controls the preferably continuously-adjustable electric actuator  30 , person  50  adjusts the inclination of apparatus  10  to the desired value. As the person&#39;s weight shifts forward onto the device, the two sides of the torso immobilizer pivot about pivots  104  and partially close about the torso of the person  50 . The degree to which the arms of the immobilizer close is controlled by the length/elasticity of the elastic straps  105 . The mesh webbing  101  between the arms forms a comfortable torso contact surface, as it stretches to some degree to fit the body type of the human  50  utilizing the apparatus, and due to the incorporation of elastic straps  105 , which may be tightened or loosened, the apparatus incorporating the torso immobilizer is essentially a one-size-fits-all unit. This pivotable net and frame design allows person  50  to be supported from the back and sides as well as from the front, thus spreading the load and forming a comfortable immobilization system. The mesh also allows for air circulation to cool the person  50 , which may be preferred when the apparatus is to be used in warmer climates and for longer durations, such as for naps or overnight sleeping. The lower-body supports  120  are preferably similar, non-pivotable hammock-type supports, but may also comprise a continuous upholstered padded surface that may be flat or contoured and may or may not leave the knee caps unsupported. In an alternative embodiment, a vest, coupled to the support surface, may grip the upper body of a person to hold the person on the support surface.  
         [0041]     As shown in  FIGS. 6 and 8 , head support  80  preferably comprises a generally circular frame  83  that supports a flexible face support  84 . Face support  84  preferably comprises a web having a round or oval  85  opening therein. The web extends across frame  83  such that when the device is inclined the web receives and comfortably supports his face. To that end face support  84  preferably comprises a fabric, such as for example, washable spandex. This would allow for the maintenance of a clean facial contact region and for the use of a person&#39;s own facial support material if he were to use an apparatus  10  that was available at a theater, for example.  
         [0042]     Head support  80  is preferably pivotably mounted on the upper end of upper body support  45 . According to the embodiment shown in  FIG. 9 , head support  80  is secured to support  45  by a pivotable bracket  87  and the lower end  86  of head support  80  engages a spring or other biasing means  82 . Biasing means  82  resists movement of lower end  86  toward support  45 , thereby also resisting forward movement of the face support. Further, head support  80  is preferably removable from the SIRA.  
         [0043]     As in the embodiment of  FIGS. 1-4 , the peripheral support  70  is shown in  FIG. 5 . Peripheral support  70  preferably pivots about pivot(s)  75  and thus may be adjusted to the desired position or moved out of the way if so desired.  
         [0044]     In any embodiment of the present invention, the weight of the lower body of person  50  is used to create tensile forces on the spine of person  50 . When the spine of person  50  is subjected to tensile forces, a mechanical creep is induced in the spine which can relieve irritation and reduce pain associated with the spine, as described hereinabove. When contoured support member  40  is inclined more toward vertical, the amount of tensile force exerted on the spine is increased. Conversely, as contoured support member  40  is rotated more towards horizontal, the amount of tensile force exerted on the spine is decreased. The user can operate controller  90  to adjust the angle of inclination until the desired amount of tension is placed on the spine. The angle of inclination may be from about 0 to about 90 degrees, alternatively from about 30 to about 90 degrees, and alternatively about 60 degrees. The use of SIRA  10  provides a simple method of relieving irritation and/or preventing degeneration of the spine and, hence, may be used to avoid much more costly and complex procedures to reduce and/or prevent spinal irritation.  
         [0045]     While preferred embodiments of this invention have been shown and described, modifications thereof can be made by one skilled in the art without departing from the scope or teaching of this invention. The embodiments described herein are exemplary only and are not limiting. Many variations and modifications of the system and apparatus are possible and are within the scope of the invention such that the relative dimensions of various parts, the materials from which the various parts are made, and other parameters can be varied. For instance, the peripheral device support may comprise a tray or shelf or other support mechanism that is hinged or otherwise articulated to allow a user to position the support to a location most comfortable for the user. Like wise, the various components of the device can be constructed from other materials and in configurations other than those shown and described herein. In addition, use of the terms “between”, “coupled to” or “connected” (and variations thereof) when describing the location of a component should not be construed such that the component must be directly contacting the adjacent components. Accordingly, the scope of protection is not limited to the embodiments described herein, but is only limited by the claims that follow, the scope of which shall include all equivalents of the subject matter of the claims.