Abstract:
A face-down recovery apparatus for use in rehabilitation of patients, particularly vitreoretinal surgical patients. The apparatus has a base and a housing that is pivotally connected to the base by an actuator. A support is positioned contiguously on the housing for received a user in a face-down position. The apparatus is moveable between a substantially vertical, upright orientation to a substantially horizontal orientation. The apparatus is in a substantially upright vertical orientation when the support receives a user in a standing position. The face of a user is secured in a face-down position in a face support, and the rest of the user is secured to the support in a standing position in an unrestricted manner permitting mobility. As the housing is tilted into a horizontal position, the user is positioned in a substantially horizontal orientation. As the user is tilted between the substantially vertical upright orientation and the substantially horizontal orientation, the user&#39;s face is continuously maintained in a face-down position in the face support.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application claims priority to and the benefit of U.S. Provisional Application No. 60/854,376, filed on Oct. 25, 2006, and is incorporated by reference and made a part hereof. 
     
    
     TECHNICAL FIELD 
       [0002]    The present invention relates generally to a method and apparatus for use in rehabilitation of surgical patients, and more particularly for the rehabilitation of vitreoretinal surgical patients. 
       BACKGROUND OF THE INVENTION 
       [0003]    Vitreoretinal surgery, repair to the rear-most wall of the eye, is commonly used to treat diabetic retinopathy, vitreous hemorrhage, hemolytic glaucoma, central vein occlusion, and macular holes/tears. Post-vitreoretinal surgery requires patients to remain face-down for extended periods of time to ensure proper healing. The macula is a small part of the retina that is responsible for clear vision. A tear or hole in the macular membrane causes the loss of central vision. Surgery consists of removing the vitreous humor, the jelly-like substance that fills the inner eye, so the surgeon can repair the damaged portion. The empty cavity is replaced with a gas bubble. Since gas rises, and the surgery takes place in the back of the eye, recovering patients must remain face-down in order for the hole to be filled with the gas bubble, keeping contact with the macula. It is imperative that patients remain in a face-down position 24 hours a day, over a period of 2-6 weeks. 
         [0004]    Ophthalmologists agree that the single greatest contributor to successful, complete recovery from vitreoretinal surgery is a patient&#39;s adherence to the regimen of maintaining the face-down position for the prescribed period of time. This yields the best results in macula re-bonding to the eye wall, allowing gradual replacement of the gas bubble by newly generated vitreous humor. 
         [0005]    The postoperative face-down position can be extremely challenging for a patient. Patients face hours of monotony, stress, discomfort, as well as atrophy of major muscle groups. The potential negative side-effects of face-down recovery are numerous. After a short period of time patients may experience stiffness of the neck and back, nasal congestion, facial swelling, and pressure points on the face. These are all common results of resting the head in one position. Extremities may grow numb because of lack of movement. Sleeping on the stomach is also difficult because the head must be turned sideways to allow adequate breathing. During face-down recovery the patient&#39;s lifestyle is restricted to minimal movement. Entertainment and other stimulation are limited by the physical constraints of currently available recovery apparatus. 
         [0006]    Vitreoretinal surgery recovery apparatus are known, however, the current systems are restrictive in many ways. A seated support system is available having a face-down chair angled to alleviate possible stress on the back, in which the patient sits or kneels in the device. Some sitting systems offer support for the knees. However, none of these systems allow for exercise of the legs and arms. Other systems offer a face support system attached to a bed or table. In such a system, the patient is also restricted to any kind of mobility, and is therefore not comfortable. Also available are face-down pillows and face-down mirrors. 
         [0007]    There is a need for a face-down recovery apparatus that adequately supports and maintains a patient&#39;s face in a fixed face-down position during recovery while permitting mobility of the rest of the body. Since the weight of the recovering patient&#39;s head must be supported adequately for long periods, there is a need for an apparatus having adequate clearance and space for breathing freely without forming dead captive spaces to harbor stale air. There is further a need for a face-down recovery apparatus that provides a built-in entertainment and/or exercise device. The present invention is directed to a recovery apparatus that encourages patients to maintain the proper face-down recovery position for the duration of the prescribed recovery period so that optimal recovery results are achieved. The present invention allows patients to proactively pursue mental, sensory, and physical activities thereby circumventing the negative side-effects of boredom, muscle atrophy and immobility. Thus, the present invention encourages exercise, rest, stress release, and creativity in order to bring the body, mind, and emotions into balance, hence, a holistic approach to healing. This holistic approach to the healing process enhances a patient&#39;s ability and personal desire to follow a physician&#39;s prescribed recovery regimen. 
       SUMMARY OF THE INVENTION 
       [0008]    The present invention provides for a face-down recovery apparatus for post-vitreoretinal surgery. The apparatus of the present invention optimizes a patient&#39;s recovery regimen by maximizing comfort and encouraging exercise and stress release. 
         [0009]    According to one aspect of the present invention, an apparatus is provided for face-down recovery of post-surgical patients. According to a first aspect of the present invention, the apparatus has a base, a housing pivotally connected to the base, and an actuator coupled between the housing and the base. The actuator has a first end pivotally connected to the base and a second end pivotally connected to the housing. A support is contiguously connected to a first side of the housing for receiving a user. The apparatus is moveable between a substantially upright vertical orientation to a substantially horizontal orientation. When the apparatus is in a substantially vertical upright orientation the support receives and secures the user to the support in the standing position in an unrestricted manner permitting mobility. As the housing is tilted, the user is positioned into a substantially horizontal orientation. In the preferred embodiment, as the user is tilted between the vertical upright and the horizontal orientations, the user&#39;s face is continuously maintained in a face support in a face-down position. 
         [0010]    According to another aspect of the present invention, the face support area may contain a silent slow speed ventilator for continuously circulating and refreshing the air in and around the face support area with fresh air from the surroundings. 
         [0011]    According to another aspect of the present invention, a transmission is located within the housing that is operably coupled to the actuator to control tilting and undulation movements of the apparatus. Such undulation movements may be intermittent and/or continuous. Furthermore, the apparatus may be tilted at any desired angle. 
         [0012]    According to a further aspect of the present invention, a foot pedal assembly and a hand pedal assembly are attached to the housing permitting the user to exercise while in the face down position. 
         [0013]    A further aspect of the present invention is a media center attached to a portion of the housing, in which the media center comprises a computer, an audio CD player, a video player, a DVD player, a computer, a television, or mp3 player. The media center is available for educational, entertainment, and therapeutic purposes to the user during the recovery process. 
     
    
     
       DESCRIPTION OF THE DRAWINGS 
         [0014]    To understand the present invention, it will now be described by way of example, with reference to the accompanying drawings in which: 
           [0015]      FIG. 1  is a side view of a user in a face-down position in accord with the present invention; 
           [0016]      FIG. 2  is a side view of a user in a face-down position in accord with the present invention; 
           [0017]      FIG. 3  is a side view of a user in a face-down position in accord with the present invention; 
           [0018]      FIG. 4  is a side view of a user in a face-down position in accord with the present invention; 
           [0019]      FIG. 5  is a side view of a user in a face-down position in accord with the present invention; 
           [0020]      FIG. 6  is a side view of a user in a face-down position in accord with the present invention; 
           [0021]      FIG. 7  is a side view of a user in a face-down position in accord with the present invention; 
           [0022]      FIG. 8  is a side view of a user in a face-down position in accord with the present invention; 
           [0023]      FIG. 9  is a side view of a chain idler assembly of the present invention; 
           [0024]      FIG. 10  is a side view of the apparatus in a substantially horizontal orientation; 
           [0025]      FIG. 11  is a side view of the apparatus in a substantially tilted orientation; 
           [0026]      FIG. 12  is a side view of the apparatus in a substantially vertical orientation; 
           [0027]      FIG. 13  is a side view of the apparatus in a substantially horizontal orientation; 
           [0028]      FIG. 14  is a side view of a transmission of the present invention; 
           [0029]      FIG. 15  is a side view of a transmission of the present invention; 
           [0030]      FIG. 16  is a side view of a user in a face-down position in accord with the present invention showing undulating movements; 
           [0031]      FIG. 17  is a side view of a user in a face-down position in accord with the present invention showing undulating movements; 
           [0032]      FIG. 18  is a side view of a user in a face-down position in accord with the present invention showing undulating movements; 
           [0033]      FIG. 19  is a side view of a user in a face-down position in accord with the present invention showing undulating movements; 
           [0034]      FIG. 20  is a side view of a user in a face-down position in a substantially vertical orientation; 
           [0035]      FIG. 21  is a side view of a user in a face-down position in a substantially horizontal orientation; 
           [0036]      FIG. 22  is a side view of a transmission of the present invention; 
           [0037]      FIG. 23  a rear view of a transmission of the present invention; 
           [0038]      FIG. 24  is a side view of a transmission of the present invention; 
           [0039]      FIG. 25  is a side view of a foot support of the present invention; and 
           [0040]      FIG. 26  is a side view of a pedal assembly of the present invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0041]    While this invention is susceptible of embodiments in many different forms, there is shown in the drawings and will herein be described in detail preferred embodiments of the invention with the understanding that the present disclosure is to be considered as an exemplification of the principles of the invention and is not intended to limit the broad aspect of the invention to the embodiments illustrated. 
         [0042]      FIGS. 1-26  show the face-down recovery apparatus of the present invention, generally designated with reference numeral  10 . The recovery apparatus is designed to maintain a patient or user&#39;s head firmly in a face-down position, with the patient&#39;s eyes focused perpendicular to the floor, while the rest of the body is sufficiently supported to alleviate strain from the patient&#39;s joints, back, legs and arms. 
         [0043]    As shown in  FIGS. 2 and 8 , the recovery apparatus  10  generally has a base  12 , a housing  14 , and a support  16 .  FIG. 2  shows the housing  14  connected to the base  12  by an actuator  18 . The actuator  18  has a first end  20  pivotally connected to the base  12 , and a second end  22  pivotally connected to the housing  14 . The actuator  18  tilts the entire apparatus  10  from a substantially horizontal position to a substantially vertical position as shown in  FIGS. 10-13 , thereby providing easy walk-on access. In an alternative embodiment, the recovery apparatus  10  may be adjusted to various desired angles to accommodate each individual as shown in  FIGS. 11 and 20 . 
         [0044]    The support  16  of the recovery apparatus  10 , is contiguously connected to the housing  14 , as shown in  FIGS. 2 and 8 . The support  16  operates to receive a patient in the face-down position, and is adjustable to receive patients from about 4′9″ to about 7′ in height. The support comprises a face support  24 , an upper torso support  26 , a lower torso support  28 , and a foot support  30 , which are operably connected to one another, and independently adjustable, to permit smooth continuous movements, or undulation movements, of key joints and muscle groups while a patient remains in the face-down position as depicted in  FIGS. 16-19 . The undulation movements are proportionally adjusted according to the height of a patient. As shown in  FIG. 2 , the face support  24  is coupled to a first end  32  of the upper torso support  26 . A second end  34  of the upper torso support  26  is pivotally connected to a first end  36  of the lower torso support  28 . The present invention significantly alleviates stress at critical joints such as the neck, arms, shoulders, pelvis, legs, and feet through selectable continuous or intermittent undulation movements. Each portion of the support  16  is padded using materials known in the art for added comfort. For example, cushioning, such as but not limited to memory foam, may be used to adjust to the size and contours of the body of the patient. Furthermore, the cushions may utilize washable cotton covers or disposable covers to ensure cleanliness. 
         [0045]      FIGS. 2 and 3  depict a first bracket  31 , having a first end  31   a  and a second end  31   b , the first end  31   a  is connected to a second end  38  of the lower torso support  28 .  FIGS. 2 and 3  also shows a second bracket  33 , having a first end  33   a  and a second end  33   b , the first end  33   a  is connected to the second end  31   b  of the first bracket  31 , and the second end  33   b  is connected to the foot support  30 . The brackets  31  and  33  are ergonomically positioned in a manner to allow a user to optionally engage his or her feet onto the foot support  30 , while the rest of the user&#39;s torso is adequately supported by the torso supports  26  and  28 . 
         [0046]    As shown in  FIGS. 3-7 , the face support  24  has an aperture  25  for receiving and securing a patient&#39;s face in a comfortable face-down position. A significant advantage of the present invention is the ability of the face support  24  to maintain a patient&#39;s face in a substantially horizontal face-down position when the patient is moved from a substantially vertical standing orientation to the horizontal face-down position, as shown in  FIGS. 10-13  and  21 - 26 . This is achieved via a drive-chain cantilevered movement between the face support  24  and a fixed pivot shaft keyed to the top of side of the support  16 , in which the roller drive chain and sprockets are oriented to maintain parallel positions by fixing one sprocket and driving the other. As such, the adjustable face support  24 , continuously promotes the face-down regimen by maintaining a patient&#39;s face parallel to the floor despite the motion of the apparatus  10 . 
         [0047]    The apparatus  10  of the present invention is designed to be either stationary or portable. In one embodiment of the present invention, a pair of wheels Y are mounted to the bottom of the base  12  to allow easy wheeling as a two wheel hand truck. Alternatively, a second pair of wheels can be mounted to the base resulting in a four-wheel dolly. The apparatus  10  may be contracted to a transport width of about 68.58 centimeters (about 27 inches), allowing easy passage through narrow doorways that are typically about 76.2 centimeters (about 30 inches) wide in a residential bedroom door. The apparatus  10  easily expands to about 91.44 centimeters (about 36 inches) in width, for stability, once the unit is placed in the position in which it will be used. Self-recessing wheels and convenient lift handles allow easy movement and handling of the apparatus from room to room, or from a delivery vehicle to a home or upstairs. The apparatus  10  is intended to be easily handled by one person, or two if dealing with stairs or lifts. 
         [0048]      FIGS. 16-21  show the interior of the housing  14  in which the transmission  40  is housed. The transmission  40  controls the tilting movements of the apparatus  10 , as well as the undulation movements of the support  16 . The control mechanisms for tilting the apparatus may be integrally connected to the controls for undulation movements. Having the undulations being driven by the same reduction train and the shifting mechanism provides an intrinsic mechanical interlock, preventing the apparatus from operating in both modes at the same time.  FIGS. 14 ,  15 ,  22  and  24  show the transmission  40  having a motor  42 , a two-position internal sprocket rack  44 , a first static sprocket  46 , a second static sprocket  48  and a motor driven motive sprocket  50  to drive separate reduction sprocket systems to perform tilting and undulation motions. In another embodiment, the tilting mechanism is motor operated by a lead screw mechanism and/or a hydraulics mechanism. In either embodiment, the apparatus  10  can be tilted from a substantially vertical position to a substantially horizontal position in about 12-15 seconds. In order to provide an environment of relaxation, slow, steady and smooth motions are achieved though liberal use of UHMW (Ultra High Molecular Weight Polyethylene) block-to-metal shaft or pin motion bearings throughout the apparatus  10 , low rotational and linear velocities, as well as liberal applications of noise and vibration reducing techniques. For example, in one embodiment, automated motion tasks are performed by a single parallel-shaft induction 1/9 HP gear motor with a reduction ratio of 40:1 and an output shaft speed of 43 RPM to keep all rotational shafts driven by gear motor operating at very low relative speeds, eliminating engagement noise of sprocket teeth on drive chains, and rotational whine on shafts, cams and bearings. 
         [0049]    The motor  42  is enclosed in an acoustic enclosure with a low-frequency tuning factor for a mid-frequency motor. The motor  42  is also mounted in acoustically optimized motor mounts to further reduce motor noise and vibration transmission of the apparatus, thereby reducing stress of the recovering patient. 
         [0050]    As shown in  FIGS. 2 ,  8 , and  10 - 13 , the apparatus  10  can integrate exercise functions via a hand pedal assembly  52 , having hand pedals  56 , and a foot pedal assembly  54 , having foot pedals  58 . The pedal assemblies may be padded for additional comfort to the patient. Portions of the hand  52  and foot pedal assemblies may be located in the housing  14 , but do not interfere with the transmission  40  as shown in  FIG. 23 . The pedal assemblies  52  and  54  are phase-shiftable via an idler to provide camel-walk or baby-crawl functions as shown in  FIG. 9 .  FIGS. 25 and 26  show one embodiment in which, the foot support  30  converts to foot pedals for exercise pedal functions. Such embodiment also provides pedal set phase-shifting independently of an idler gear set. 
         [0051]      FIGS. 10-13  and  16 - 21  show the apparatus  10  in operation. In use, one of the benefits of the present invention is that the face-support  24  maintains a patient&#39;s face parallel to the floor as the apparatus tilts from a substantially vertical orientation to a substantially horizontal orientation as shown in  FIGS. 10-13  and  16 - 21 . It serves to maintain the head firmly in a proper position with the center focus of eyes perpendicular to the floor, and the rest of the body optimally supported to remove strain from joints, the back, legs and arms. 
         [0052]    The method and apparatus of the present invention makes use of a tilt mechanism to provide easy walk-on access. The housing  12  and support  16  tilt 90 degrees to allow walk-on access. By way of example, a regular operating orientation is shown in  FIG. 10 , while the partial tilt to vertical orientation is shown in  FIG. 11 .  FIG. 12  illustrates full vertical mounting position and  FIG. 13  illustrates the return to the operating position. An alternative embodiment as shown in  FIGS. 20 and 21  is to tilt the housing to only 80 degrees from horizontal position, forcing the walk-on patient to lean forward against the housing to provide a balance bias forward in the same direction as the tilt to horizontal position. Consequently, this commits the user&#39;s weight in a forward direction providing greater vertical stability during the mounting and tilting procedure. 
         [0053]    When the apparatus  10  is not in use, it can be stored in a substantially vertical orientation. This allows a patient to readily store the apparatus  10  in a closet or other storage facility. When a patient is ready to use the apparatus  10 , the apparatus is adjusted to a substantially vertical position as show in  FIGS. 12 and 20 , so that a patient can readily walk onto the apparatus  10 . As shown in  FIG. 20 , in one embodiment the apparatus is tilted at a 10° angle when in the resting position for easier walk-on access. When the apparatus  10  is in a resting position, a safety lock mechanism can be engaged to ensure that the device does not prematurely shift into an undesired position. In the event of mechanical failure of any component of the tilting mechanism, an automotive-type shock absorber is provided to assure a highly damped, gradual tilting of the mechanism to either the horizontal or vertical position dependent upon the prevalent weight distribution at the time. Once the patient mounts the apparatus  10 , the patient&#39;s face is securely fixed in a face-down position in the aperture  25  of the face support  24 , as shown in  FIG. 20 . The torso of the patient&#39;s body may be secured to the torso supports  26  and  28  using a restraint strap or belt as known in the art. Alternatively, guardrails may be provided alongside the torso area of the support  16  to prevent a patient from rolling off the apparatus. When the patient is ready to tilt into the horizontal orientation, the safety lock is disengaged, and the motor  42  is started thereby activating the motor driven sprocket  50  of the transmission  40 , which in turn tilts the housing  14  and support  16  to any desired angle. The interrelated movements of the motor motive driven sprocket  50  in relation to the static sprockets  46  and  48  affecting the tilting motion are depicted in greater detail in FIGS.  14  and  15 - 21 . Slow and steady motions are achieved through liberal use of Ultra High Molecular Weight Polyethylene (UHMW) to metal motion bearings throughout the apparatus, as well as low rotational and linear velocities. 
         [0054]    In a preferred embodiment, the housing  14  and support  16  are tilted to a horizontal orientation as shown in  FIG. 16 . When the apparatus  10  is in complete horizontal orientation, a user&#39;s body weight is evenly supported on the proximal side of the body from head to feet across the support  16 . One of the advantages of the present apparatus is that the support  16  adequately supports and distributes the weight of the user throughout the entire apparatus, preventing dead captive spaces to facilitate unobstructed breathing and comfortable sleeping positions. A small, slow speed silent ventilator  59  in the general area of the face support keeps a constant supply of fresh air circulated in the breathing area is shown in  FIG. 16 . 
         [0055]      FIGS. 16-19  illustrate the present invention in which a user&#39;s head is firmly nested in a face-down position with the rest of the body located at an optimal and/or continuously variable angle or angles. When activated, the entire active apparatus may be adjusted to various angles to accommodate each individual user. Relative angles may be established between the (face-down) head and back with a pivot at the neck; between the lower back and thighs with a pivot at the hips; between the thighs and the lower leg with a pivot at the knees. The plurality of pivot connections between the various segments  24 ,  26 ,  28 , and  30  of the support  16  can be continuously or intermittently set in motion while the user is in the horizontal orientation. As further shown in  FIGS. 3-6 , the supports on which the body is mounted permit continuous movement, undulations, of key joints and muscle groups while in a static resting position using a powered adjustable speed coordinated motion control to provide movement therapy. Such movements are further illustrated in FIGS.  7  and  16 - 19 . The intermittent and/or continuous movement of the plurality of pivots allows various limbs to change angles preventing stiffness and fatigue to muscles and joints. 
         [0056]    In another embodiment, the method and apparatus of the present invention may be in the form of an exercise center, as described above, providing a horizontal exercise bike for arms, legs, torso, neck, shoulders and buttocks, as illustrated in  FIG. 8 . The pedals provide a smooth rotary motion as opposed to an erratic reciprocal motion and allow a choice of motions of either infant crawling (or opposite arm and leg coordination on the same side) or camel-like crawling where both the left and right sides (arms and legs) move in unison.  FIG. 9  illustrates a shifting pedal chain idler  60  from upper to lower position on the left changes front or rear pedal position phasing 90 degrees as in crawling or camel walk. Significantly, the shifting pedal chain idler  60  facilitates simultaneous changing of the foot and hand pedals. In another embodiment, the pedal phase shifting is accomplished in the pedal-foot rest shift, as shown in  FIGS. 25 and 26 . 
         [0057]    The holistic face-down recovery center of this invention incorporates features making it easy to use, move, and maintain. For example, in another embodiment of the present invention, convenient slide-out removable trays provide cushioned supports for arms during periods of sleep in the face-down position. Additionally, a slide-in meal tray and a media center may be mounted to the housing  14  as shown in  FIG. 2 , that are easily accessible because the arms can reach to any position. The media center may include, but is not limited to, computers, audio CD players, videos (VHS and/or DVD) enhanced by surround sound, internet access, and radio, television, and mp3 connectivity. A 3-way mirror may also be attached to the housing so the patient may see forward while maintaining the correct face down position. The cushions adjust to size and contours of the body of the patient, as such, back pressure is minimal and sleep is comfortable. Additionally, a small motorized silent low-speed ventilator  59  may be mounted in proximity to the face-down support to continuously refresh the breathing area with fresh air. Optionally, an adjustable full color camera with zoom allows 360 degree vision via a laptop computer screen. 
         [0058]    The method and apparatus of the present invention encourages patients to exercise, rest, sleep and even tap into their creativity. Its accessibility in either the horizontal or vertical positions, its adaptability for all bodies, and its functionality heartens the patient and eliminates monotony, stress, discomfort, and muscular atrophy. The present invention is applicable to other types and forms of highly constrictive or immobile recovery regimens for treatment for conditions other than those of the eyes such as, but not limited to, burn patients or joint and/or bone injuries. 
         [0059]    While the specific embodiments have been illustrated and described, numerous modifications come to mind without significantly departing from the spirit of the invention, and the scope of protection is only limited by the scope of the accompanying claims.