Abstract:
An ergonomically designed ambulatory walking device comprised of a bicycle seat supported by an offset seat post that can be used for both right and left injuries. Different handlebar configurations can move the user&#39;s hands any number of different positions laterally to the right or left, higher and lower in relationship to the seat and closer and farther from the pelvis. Different frame sizes and height and seat to hand spread make it possible to fine tune a person&#39;s balance by selecting standardized parts. The dispensing method allows for verification of doctor&#39;s orders and the procedure for selecting parts by a trained individual allows for proper body positioning of the user. The new and simplified frame design, along with its various components and stabilizers, help persons needing more assistance. The method for adjusting and dispensing these devices uses computer software and the Internet or a fax machine, making it possible to deliver the correct walker to an individual virtually anywhere in the world.

Description:
BACKGROUND OF THE INVENTION  
       [0001]     The present invention relates generally to a seated ambulatory device in a simple manufacturing design with few frame parts, and a method and tools for adjustment, comprised of a number of interchangeable components. The device can be adjusted for greater balance for a wider and diverse group of patients. Using the Internet can greatly improve ordering and distribution of properly sized components, thereby helping to simplify assembly and increase strength of the device by using the most desirable parts while reducing cost.  
         [0002]     When a person loses a lower limb or has had a serious leg injury, there is a time when healing of the leg or stump makes it impossible for the individual to ambulate. So technically, wheelchairs and traditional walkers are used for the rehab process. In many cases, this is ineffective because of injuries to the shoulders, hands suffering from carpal tunnel, bursitis in the shoulder or torn rotator cuffs of the shoulder.  
         [0003]     Medical devices have been developed to facilitate ambulating. U.S. Pat. No. 5,524,658 issued Jun. 11, 1999 to Joseph F. Schrader and entitled  Sit to Stand Hinged Seat Walker with Pull - up Handles  also employs a vertical upright post with a planar seat that locks in a vertical position.  
         [0004]     U.S. Pat. No. 6,959,716 B1, issued Nov. 1, 2005 to Joseph F. Schrader and entitled  Ergonomically Designed Walker  also has an offset seat post and adjustable handle grip bars.  
         [0005]     These devices fall short in simplification. The frames are dependent on the specific right or left frames being used. The potential of an incorrect frame being selected for a patient is eliminated with the present method for measuring and dispensing. Adjustment of the prior devices often requires custom made components to achieve a balancing point that is comfortable. The movement of the individual&#39;s hands is limited without the ability to move them in lateral directions or to vary their height in relationship to the seat. With the improved ergonomic handles, handlebars and the dispensing system of the present invention, the therapist or prosthetist can give the user a greater degree of control over the position of the stabilization foot in a much shorter period of time with verifiability that the adjustments were made in accordance with the doctor&#39;s orders.  
         [0006]     It is the object of this new and improved invention to better position the upper body and hands with new handlebar components, making proper placement of a person&#39;s core, forward and aft and laterally, not possible with prior inventions. The more simplified frame has an offset seat post component that is adjustable both to the right or left side, not possible with prior frames. A new stabilization system gives greater stability for people who have balance difficulties, making it possible for very accurate body positioning to achieve balance for these individuals, using standardized parts, making adjusting far simpler and faster, and saving time and money.  
       SUMMARY OF THE INVENTION  
       [0007]     The present invention relates generally to a seated walking ambulatory device that has a much simpler manufacturing design with fewer frame parts and a method and tools for adjustment comprised of a number of interchangeable components that can be adjusted for greater balance for a wider and diverse group of patients. Using this new apparatus and the method using the Internet can greatly improve ordering and distribution of properly sized components, helping to simplify and, while using the most desirable parts, increasing strength and reducing cost. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0008]      FIGS. 1 and 2  are perspective views of two embodiments of the present invention as used by a person as shown in phantom.  
         [0009]      FIG. 3  is a flow diagram illustrating a method for dispensing the present invention.  
         [0010]      FIG. 4  is a right side view of one embodiment of the present invention.  
         [0011]      FIGS. 5-8  are various views of the handlebar portion of the present invention, indicating the adjustments that can be made thereto.  
         [0012]      FIG. 9  is a right side view of a preferred embodiment of the present invention.  
         [0013]      FIGS. 10 and 11  are indicative of various sizes of the frame thereof.  
         [0014]      FIGS. 12 and 13  are alternative designs of the foot portion thereof.  
         [0015]      FIGS. 14 and 15  show the relationship between the adjustable handles and the stabilizer portion thereof.  
         [0016]      FIGS. 16 and 17  show variations of the stabilizer portion thereof.  
         [0017]      FIGS. 18-21  show various views indicating the adjustment of the device for particular users.  
         [0018]      FIGS. 22-25  show various adjusted positions of the stabilizer for particular patient needs.  
         [0019]      FIG. 26  is a right side elevational view of the invention in accordance with a preferred embodiment.  
         [0020]      FIG. 27  is a front elevational view thereof.  
         [0021]      FIG. 28  is a front elevational view thereof with a different adjusted position of the stabilizer portion thereof.  
         [0022]      FIGS. 29-32  show various features of the present invention as used with a pelvic leveler seat. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0023]     Referring to the drawings in detail,  FIG. 1  shows a phantom amputee sitting on one embodiment of the inventive walker  40  designed for a right leg amputee, with the device being properly adjusted for height of the seat, height of the hands and the distance of the hands from the pelvis to achieve proper balance and posture.  
         [0024]      FIG. 2  shows, the same phantom amputee as sitting on a right injured limb offset frame assembly  64  in accordance with another embodiment of the invention. The user is in a natural comfortable stance with little curvature of the spine.  
         [0025]      FIG. 3  is a flow chart showing a method for dispensing the walker  64  by verifying the correct walker for the injury. It is a check and balance system for the physician, therapist and the dispensing facility.  
         [0026]     In block  201 , a patient is evaluated by a physician as a suitable candidate for the device. The physician writes a prescription to that effect and fills out sections of a template form provided by the supplier of the device.  
         [0027]     The patient&#39;s personal and contact information (name, address, etc.), as well as the type of injury or disease, and leg involved are noted and sent to the main data processing facility via email, fax or US Postal Service.  
         [0028]     Remaining fields are later filled as determined by the therapist to include the patient&#39;s weight and inseam length. Other fields are devoted to measurements and walker components consisting of foot type, frame type, seat type, bar end type, seat post size, handle height, floor-to-seat height, and frame offset.  
         [0029]     In block  202 , the physician form information is entered into a database at a data processing center.  
         [0030]     In block  203 , form fields are validated for appropriate input type and are cross-referenced with an ongoing, updated database built from studies and relevant content to see if certain criteria are met. If the patient data is invalid or specific conditions are not met, the form is rejected and returned to the physician for correction or reconsideration.  
         [0031]     In block  204 , the software approves the order for assembly, selecting barcoded components from the database per the physician&#39;s specifications. This “build-list” is generated and sent by the main computer to another local or remote computer at a warehouse/storage facility.  
         [0032]     In block  205 , primary and specific parts are gathered at the facility.  
         [0033]     In block  206 , each part is scanned, comparing its barcode to those on the “build-list.” 
         [0034]     In block  207 , if a conflict occurs, the warehouse is notified that incorrect parts were shipped.  
         [0035]     In block  208 , positive verification results in a “variation number”, generated as a barcode sticker for attachment to the walker frame. This number is unique to the individual user. The variation number is transmitted to the main computer for inclusion in a database and patient record.  
         [0036]     In block  209 , the device is assembled and checked by a quality control specialist. Scans of unique barcode labels and the variation number are performed. The latter number is also duplicated for attachment to the walker&#39;s shipping box. An address label is printed for the shipping box which is then sealed.  
         [0037]     In block  210 , the walker is sent via a transportation carrier to a therapist or technician.  
         [0038]     In block  211 , the therapist scans the walker&#39;s frame barcode. Software validates if the correct device was received.  
         [0039]     In block  212 , the computer system identifies whether a shipping or prescription error occurred.  
         [0040]     In block  213 , the applicable source is notified.  
         [0041]     In block  214 , if the appropriate walker was received, the therapist adjusts components, fitting the device to the patient&#39;s needs. He records measurements in the related fields of the template form for transmission and entry into the main database.  
         [0042]     In block  215 , the therapist trains the patient in the proper use of the walker device, and upon successful completion of that task, certifies the patient and dispenses the walker to him/her.  
         [0043]      FIG. 4  illustrates one embodiment of the walker device  40  that shows the up and down movement of the foot assembly  39 , the saddle post tube  42  and the handlebar T  12 . The arrows at C, D and E show the ability to adjust the position of the handlebar  6  by loosening and tightening handlebar adjuster clamp cap screws  9 . The arrow at F shows the ability to vertically position the saddle  34  by loosening and tightening the quick release saddle post clamp  44 . The arrows at G and H show the vertical adjustability of the walker measuring simulator  40  by loosening and tightening simulator adjuster clamp cap screw  51  and the simulator upper  50 A and lower  50 B adjuster clamp.  
         [0044]     The arrow at I shows the adjustability of the foot assembly  39  by loosening and tightening the foot assembly quick release clamp  48 . The foot assembly receiver tube  56  has a receiver tube spring retainer  60  being held in position by the foot assembly receiver tube clamp  58 . The receiver tube spring  62  pushes against the receiver tube spring retainer  60  and the foot post  29 .  
         [0045]      FIG. 5  is a view of the multi-adjustable T bar assembly  5  that allows for changeable handlebars  6  of varying lengths for changing hand locations and separation. The handlebar T  12  accepts varying lengths of the handlebar right adjuster clamp  8 A and handlebar left adjuster clamp  8 B which allows handlebar  6  to be moved horizontally.  
         [0046]      FIG. 6  is a view of a telescopic version of the handlebar assembly  15  comprised of the handlebar  6  which can slide horizontally and be held in position by the handlebar T support tube clamp  16  and clamp cap screw  17 . It should be recognized that both the offset positions of the two ends  2 A and  2 B, as well as their separation distance can be selectively varied. T bar handle right end  2 A and left end  2 B can be tilted or rotated to a comfortable position. The vertical handlebar support tube  13  may vary in length.  
         [0047]      FIG. 7  is an enlarged view of the handlebar adjuster clamp assembly  7  shown in  FIG. 5 . There are two sizes shown, with handle bar adjuster clamp  8  and handlebar adjuster clamp cap screw  9 . They can be varied in size to allow the walker to be specifically adjusted for hand placement for proper upper body positioning of a particular user. For any one user the length of the assemblies are the same.  
         [0048]      FIG. 8  shows a sliding handlebar assembly  15  which has a handlebar support tube  14  positioned by the handlebar T support tube  16  and the clamp cap screw  17 . It should be recognized that the features shown in  FIGS. 5-8  are equally applicable to the embodiment shown in  FIG. 9 .  
         [0049]      FIG. 9  is a view of a preferred embodiment of the walker assembly  21 . The saddle  34  is attached to saddle post  30  by saddle clamp assembly  32 . The saddle post clamp  28  attaches to the offset support tube top  31 T. Foot post clamp  35  is attached to offset support tube bottom  31 B which retains foot post  29 .  
         [0050]      FIG. 10  shows a short walker frame  18  with upper T bar support tube  23  welded to offset support tube  31  and reinforced by frame gusset  24 .  
         [0051]      FIG. 11  shows a longer walker frame  20  which is identical in components to  FIG. 10  and varying only in size.  
         [0052]      FIG. 12  shows the foot assembly  39  with a short foot post  36  which is attached to offset support tube  31  as shown in  FIG. 9 .  
         [0053]      FIG. 13  shows the foot assembly  39  with a longer foot post  38  to allow for greater versatility of the walker assembly  21  as shown in  FIG. 9 .  
         [0054]      FIG. 14  shows a right injured limb offset frame assembly  64  with right stabilizer assembly  67  added for additional stability for the user. The T bar handle right end  2 A and left end  2 B are offset to position a person&#39;s upper body more over the residual (i.e. the remaining) limb.  
         [0055]      FIG. 15  shows a left injured limb offset frame assembly  66  with a left stabilizer assembly  69  and a multi-adjustable tube bar assembly  5  as shown in  FIG. 5 . The T bar handle right end  2 A and left end  2 B are more centered than in  FIG. 14 . In this regard, it should be recognized that the position of the handlebars will be selectively varied to best fit the needs of the user.  
         [0056]      FIG. 16  is a detailed view of the right stabilizer assembly  67  shown in  FIG. 14 . It is comprised of a rear stabilizer post  74  that is held in place by a rear stabilizer adjuster clamp assembly  70  which also clamps to the foot post  29  below the foot post clamp  35  and above the front stabilizer adjuster clamp assembly  68 , held in place by the stabilizer cap screw  80 . The rear stabilizer post  74  inserts into the rear stabilizer post tip  78 . Similarly, the front stabilizer post  72  inserts into front stabilizer post tip  76 .  
         [0057]      FIG. 17  is identical to  FIG. 16  but the front stabilizer adjuster clamp assembly  68  and rear stabilizer adjuster clamp assembly  70  are positioned to the left of foot assembly  39  instead of to the right as shown in  FIG. 16 .  
         [0058]      FIG. 18  shows a left injured limb offset frame assembly  66  being adjusted using an acrylic 90 degree adjustment guide  82 . Frame  66  is laid on a flat surface  90  with the T bar handle right end  2 A and left end  2 B and the front of foot assembly  41  resting on a flat surface  90 . Handlebar T clamp assembly cap screw  25 , saddle post clamp cap screw  27  and foot post clamp screw  33  are loosened. Small bar coded adjustment bar left  86 L is positioned between the offset support tube top  31 T and the adjustment guide  82  at its uppermost end. The groove in block  94  allows adjustment spacer  86  or  88  to press onto 90 degree adjustment guide  82 . The adjustment guide  82  also rests against upper T bar support tube  23 . After proper adjustments to the frame assembly  66  are made, handlebar T clamp assembly cap screw  25 , saddle post clamp cap screw  27  and foot post clamp are retightened.  
         [0059]      FIG. 19  is an enlarged view of acrylic 90 degree adjustment guide  82 , adjustment guide base  84 , small bar coded adjustment spacer  86  and large bar coded adjustment spacer  88  as shown being used in  FIG. 18  for adjustment of the frame assembly  66 . While the adjustment guide  82  is standard for all users, the small bar coded adjustment bar  86  and the spacer  88  are specific to the needs of the user and are used in providing any desired offset between the tube top  31 T and the tube bottom  31 B as shown in  FIGS. 20-22 .  
         [0060]      FIG. 20  is a bottom view of a left injured offset frame  66  with the foot assembly  39  removed for a clearer view. It shows T bar handle right end  2 A and left end  2 B resting on flat surface  90 . The phantom saddle  34 A is positioned perpendicular to the flat surface with the front of saddle  34 A pointing straight down toward the flat surface  90 . The small bar coded adjustment spacer  86 L is resting against the offset support tube top  31  T on the left side as shown and left acrylic 90 degree adjustment guide  82 L is resting against the upper T bar support tube  23 .  
         [0061]      FIG. 21  shows a right injured limb offset frame assembly  64  being adjusted using the same procedure outlined in  FIG. 20 .  
         [0062]      FIG. 22  is a bottom view of a left injured limb offset frame assembly  66  looking from the bottom of the foot assembly  39 . T bar handle right end  2 A and T bar handle left end  2 B are resting on flat surface  90  as is front stabilizer post tip  76 . The offset support tube top  31 T and bottom  31 B are shown in an offset position.  
         [0063]      FIG. 23  is a bottom view of left injured limb offset frame assembly  66  looking from the bottom of foot assembly  39 . The arrow at J shows the direction of the assembly  66  at the end of the step.  
         [0064]      FIG. 24  is a bottom view of left injured limb offset frame assembly  66  looking from the bottom of foot assembly  39 . The front of foot assembly  42  is resting on an incrementally sized bar coded adjustment block  92 . Front stabilizer post tip  76  is also resting on flat surface  90 . The use of the adjustment block  92  causes the front stabilizer post tip  76  to be positioned forward of the front of the foot assembly  41 . This an important feature for purposes of shifting the weight of a user as will be seen in  FIG. 25 .  
         [0065]      FIG. 25  is a bottom view of left injured limb offset frame assembly  66  looking from the bottom of foot assembly  39 . The arrow at K shows the direction of the assembly  66  at the end of a step. That is, because of the forward position of the front stabilizer post tip  76 , the movement of the assembly in the direction of the arrow K tends to shift the weight of a person to the residual limb. The offset support tube top  31 T and bottom  31 B are shown in the same offset position as in  FIG. 22 .  
         [0066]      FIG. 26  is a right side elevational view of a left injured limb offset frame assembly  66 . Arrow HL represents handle lift direction. The arrow at C 3  represents the rotation of the assembly  66  about the T bar handle right end  2 A and left end  2 B. BP 1  represents the balance point of the assembly  66  forward and aft. The arrow at C 4  represents the arc of the foot assembly  39  as the assembly is advanced by the user.  
         [0067]      FIG. 27  is a front elevational view of left injured limb offset frame assembly  66  showing the lateral balance point BP 2 . It should be recognized that the T bar handle left end  2 B is closer to BP 2  than T bar handle right end  2 A making the handle lift equal on each side causing left injured limb offset frame assembly  66  to pivot as in  FIG. 26 . This tends to equalize the lifting in the hands, considering that the equalizer is added to one side. It also allows for better body positioning on the sound side giving the person better body alignment and balance.  
         [0068]      FIG. 28  is a front elevational view of left injured limb offset frame assembly  66 . Arrow K 1  shows the lateral direction the frame  66  travels at the end of a step which returns a person back to their sound side. This is a result of the front stabilizer post tip  76  being forward of leading edge of foot assembly  39 . Arrow LS shows the offset position of saddle  34  over the foot assembly  39 .  
         [0069]      FIG. 29  shows a phantom hemipelvectomy with SP 1  showing the spine with little curvature as a result of using a pelvic leveler seat  96 .  
         [0070]      FIG. 30  shows a phantom hemipelvectomy resting upon left injured limb offset frame assembly  66  with a pelvic leveler seat  96 .  
         [0071]      FIG. 31  is a phantom hemipelvectomy showing SP 2  with considerable curvature.  
         [0072]      FIG. 32  is a perspective and mostly top view of a pelvic leveler seat  96 .