Patent Publication Number: US-2009240174-A1

Title: Apparatus and methods for the prevention of venous thromboembolism

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present application claims the priority and benefit of U.S. Provisional Application 61/034736 filed on Mar. 7, 2008, which is hereby incorporated by reference in its entirety herein. 
    
    
     BACKGROUND OF THE INVENTION 
     The present disclosure relates to apparatus and methods for the prevention of venous thromboembolism and generally related morbidities. 
     It is generally recognized that stasis of the venous blood flow in the lower extremities contribute to thrombus formation. Sedentary life styles and periods of inactivity associated with, for example, periods of prolonged sitting such as experienced by travelers on an airplane on an extended journey or office workers generally confined to a desk for long hours may result in stasis of the venous blood in the feet and legs that could result in venous thromboembolism. 
     Various pharmaceuticals are available for the prevention of thromboembolism. These pharmaceuticals may act by thinning the blood (anticoagulants) thereby maintaining blood flow through the venous system to prevent thrombus formation. However, the pharmaceuticals may be expensive, require medical supervision, and may have side effects that may be significant. The use of pharmaceuticals may be contraindicated in some individuals. 
     Movement of the feet and legs that stimulates the flow of venous blood thereabout is recognized as a preventative measure, and, accordingly, various devices have been developed for use in stimulating the flow of blood in the feet and legs. However, a need still exists for an apparatus that may, for example, be carried about by a traveler and used to stimulate venous blood flow the feet and legs within the confines of an airplane or similar confined space. 
     BRIEF SUMMARY OF THE INVENTION 
     These and other needs as well as various disadvantages of the related art may be overcome by the apparatus and methods disclosed herein. Additional improvements and advantages may be recognized by those of ordinary skill in the art upon study of the present disclosure. 
     In various aspects, the apparatus disclosed herein includes a foot rocker for the prevention of venous thromboembolism generally in the foot and leg. The foot rocker, in various aspects, includes a foot support adapted to generally receive at least portions of a plantar surface of a foot thereupon. In various aspects, a rocker is engaged with the foot support, and the rocker is positionable between a storage position and a deployed position. The rocker in the deployed position supports the foot support such that the foot support is oscillatable with a rocking motion stimulative to the foot and leg. The rocking motion of the foot support is stimulative to the foot and leg by causing dorsi flexion and plantar flexion of the foot engaged therewith that enhances venous blood flow thereabout in various aspects. 
     Methods for the prevention of venous thromboembolism generally in the foot and leg are disclosed herein. In various aspects, the methods may include the steps of positioning one or more rockers engaged with a foot support from a storage position into a deployed position, engaging at least portions of a plantar surface of a foot with a surface of the foot support following the step of positioning one or more rockers engaged with a foot support from a storage position into a deployed position, and causing dorsi flexion and plantar flexion of the foot by oscillating the foot support with at least portions of the plantar surface of the foot engaged therewith in a rocking motion upon the one or more rockers. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS  
       FIG. I illustrates by perspective view an exemplary implementation of a foot rocker; 
         FIG. 2  illustrates by a bottom view an exemplary implementations of the foot rocker and a second foot rocker; 
         FIG. 3A  illustrates by side view and exemplary implementation of the foot rocker with a rocker positioned in the deployed position; 
         FIG. 3B  illustrates by side view an exemplary implementation of the foot rocker with the rocker positioned in the storage position; 
         FIG. 4A  illustrates by bottom view portions of an exemplary implementation of the foot rocker with the rocker in the storage position; 
         FIG. 4B  illustrates by side cut-away view in general correspondence to  FIG. 4A  of portions of an exemplary implementation of the foot rocker with the rocker in the storage position; 
         FIG. 4C  illustrates by bottom view portions of an exemplary implementation of the foot rocker with the rocker in the deployed position; 
         FIG. 4D  illustrates by side cut-away view in general correspondence to  FIG. 4C  of portions of an exemplary implementation of the foot rocker with the rocker in the deployed position; and 
         FIG. 5  illustrates by cut away view portions of an exemplary male fitting and opposing socket. 
     
    
    
     The Figures are to facilitate explanation of the present invention. The number, position, relationship and dimensions of the parts shown in the Figures to form the various implementations described herein, as well as dimensions and dimensional proportions to conform to specific force, weight, strength, flow and similar requirements, are explained herein or are understandable to a person of ordinary skill in the art upon study of this disclosure. Where used in various Figures, the same numerals designate the same or similar parts. Furthermore, when the terms “top,” “bottom,” “right,” “left,” “forward,” “rear,” “first,” “second,” “inside,” “outside,” and similar terms are used, the terms should be understood in reference to the orientation of the structures shown in the drawings and utilized to facilitate understanding. 
     DETAILED DESCRIPTION OF THE INVENTION  
     Apparatus and methods for the prevention of venous thromboembolism generally in the foot and leg are disclosed herein. The apparatus, in various aspects, includes a foot rocker having a foot support adapted to generally receive at least portions of a plantar surface of a foot thereupon. One or more rockers are engaged with the foot support. The one or more rockers are positionable between a storage position and a deployed position. When positioned in the storage position, the one or more rockers may generally assume a minimal aspect that may enhance the storability and portability of the foot rocker. The one or more rockers, when placed in the deployed position, support the foot support such that the foot support may oscillate upon the one or more rockers with a rocking motion generally stimulative to the foot and leg. This stimulation to the foot and leg, in various aspects, includes dorsi flexion and plantar flexion of the foot caused by the rocking motion of the foot rocker with the user&#39;s foot engaged therewith. The dorsi flexion and plantar flexion of the foot may enhance venous blood flow about the foot and leg and thus prevent stasis of venous blood flow and associated morbidities such as thrombus formation. So stimulating the foot may relieve edema including prevention and reduction of edema in the lower extremities including the foot and/or leg. The nerves and muscles in this region may be stimulated, and other therapeutic benefits may accrue. The other therapeutic benefits from the rocking motion may include substantially psychological benefits such as stress relief and general relaxation, which could have physiological manifestations. 
     Accordingly, in order to deliver the preventative therapy to the foot and/or leg, a user may place a portion of the plantar surface of the foot upon the foot support and then induce a rocking oscillation of the foot support to stimulate the foot and leg. The user may so stimulate the foot and/or leg for a therapeutically effective period of time to prevent venous thromboembolism and/or cause other beneficial effects. 
     In various aspects, the apparatus disclosed herein further includes a second foot support with one or more rockers engaged thereto and positionable between a deployed position and a storage position. The rockers engaged with the second foot support may be positioned in the deployed position, and the second foot support may oscillate thereupon to provide stimulus to a second foot and leg of the user. Accordingly, the user may utilize the foot support and the second foot support to stimulate both feet and legs simultaneously or sequentially. With the rockers associated with the foot support and the second foot support placed in the storage position, the foot support and the second foot support may be releasably engaged with one another for transport and/or storage. In various aspects, the assemblage of foot support coupled to the second foot support may be generally portable. The assemblage may be generally pocket sized in some aspects. In some aspects, the assemblage may generally define a rectangle with a side of the rectangle ranging between about 6 inches (15 cm) and about 8 inches (20 cm) in length and a second side of the rectangle ranging between about 4 inches (10 cm) and about 6 inches (15 cm) in length. The thickness of the assemblage may be generally less than 2 inches (5 cm) in various aspects, and, in some aspects, the thickness of the assemblage may be generally about 1 inch (2.5 cm). 
     Methods for the prevention of venous thromboembolism generally in the foot and leg are disclosed herein. In various aspects, the methods may include the step of positioning one or more rockers engaged with a foot support from a storage position into a deployed position. The methods may include the steps of engaging at least portions of a plantar surface of a foot with a surface of the foot support, and stimulating the foot and leg by oscillating the foot support in a rocking motion upon the one or more rockers whilst the foot is so engaged with the foot support. 
     Turning now to the Figures, it is to be recognized that the Figures referenced herein generally illustrate various exemplary implementations of the apparatus and the associated methods disclosed herein. These illustrated implementations are not meant to limit the scope of coverage, but, instead, to assist in understanding the context of the language used in this specification and in the claims. Accordingly, variations of the apparatus and methods that differ from these illustrated implementations may be encompassed by the appended claims that alone define the invention. 
       FIG. 1  illustrates an implementation of the apparatus  10  for the prevention of venous thromboembolism including foot rocker  12 . The foot rocker  12  including foot support  20 , rocker  30 , and rocker  40  may be formed of plastic, wood, metal, or combinations thereof in various implementations, as would be recognized by those of ordinary skill in the art upon study of this disclosure. Other implementations may include more or fewer rockers. As illustrated, the foot rocker  12  includes rocker  30  and rocker  40  engaged with foot support  20 . Rocker  30  and rocker  40  are illustrated in FIG. I as positioned in deployed positions  31 ,  41 , respectively. Accordingly, rocker  30  and rocker  40  may rest upon surface  400 , and oscillate upon surface  400  so that the foot support  20  may oscillate upon rocker  30  and rocker  40  with a rocking motion, as indicated by the curved arrows in the Figure. Surface  400  may be a floor, deck, or similar surface. 
     The foot support  20  defines surface  23  that engages the foot of the user. The foot support  20  including surface  23  may be generally sized and shaped to accommodate the foot of the user. In various implementations, the surface  23  may be made of a material that is comfortable when applied to the plantar surface of the foot. In various implementations, the surface  23  may be configured with ribs, nubs, various forms of roughness, textures, and so forth (not shown) that may enhance the engagement of the surface  23  with the plantar surface of the foot, portions of a shoe and/or stocking interposed between the plantar surface of the foot and surface  23 , and/or provide stimulation to the foot. 
     Rocker  30  and rocker  40  are engaged with the foot support  20  and support the foot support  20  above the surface  400  when positioned in the deployed positions  31 ,  41 , as illustrated in  FIG. 1 . Rocker  30  and rocker  40  in various implementation have a generally curved form such that, when positioned in the deployed positions  31 ,  41  upon surface  400 , rocker  30  and rocker  40  and, hence, the foot support  20  engaged with rocker  30  and rocker  40  may oscillate upon surface  400  with a rocking motion. The curvature of the rockers  30 ,  40  could assume a variety of forms such as an essentially semi-circular form in some implementations, or a more parabolic or hyperbolic form in other implementations. Portions of rocker surfaces  32 ,  42  defined by rockers  30 ,  40 , respectively rest upon surface  400 , as illustrated in  FIG. 1 , and, accordingly, at least portions of rocker surfaces  32 ,  42  may be formed with various materials such as rubber and/or roughened in various ways that increase the friction between rocker surfaces  32 ,  42  and surface  400  in order to prevent generally the foot rocker  12  from sliding about surface  400  while oscillating upon surface  400 . Rocker surfaces  32 ,  42  may be substantially flat in cross-section, may be curved in cross-section, or have various other cross-sectional shapes and these cross-sectional shapes may be chosen to enhance frictional contact between rocker surfaces  32 ,  42  and surface  400  or to enhance the instability of the rockers  30 ,  40  upon surface  400  in order to provoke the oscillatory rocking motion of the foot rocker  12 . 
       FIG. 2  illustrates an implementation of apparatus  10  that includes foot rocker  12  and further includes foot rocker  110 . Foot support  20  of foot rocker  12 , as illustrated in  FIG. 2 , is formed to define a rim  22  generally about the periphery and defines surface  24 , with surface  24  being opposite to surface  23  ( FIG. 1 ). The rim  22  in combination with the surface  24  of foot support  20  defines an open cavity  25  in this implementation. Rocker  30  and rocker  40  are hingedly secured to the foot support  20 , and are illustrated in  FIG. 2  as positioned in the storage position  33  and storage position  43 , respectively, wherein rocker  30  and rocker  40  are generally disposed within the cavity  25  defined by the foot support  20 . Rocker end  36  of rocker  30  is engaged with hinge  37  and rocker end  34  is engaged with hinge  35  in this implementation. As illustrated in  FIG. 2 , hinges  35 ,  37  allow rocker  30  to pivot in order to be positioned between the storage position  33  and the deployed position  31 , which is illustrated in phantom. In this implementation, rocker end  46  of rocker  40  is engaged with hinge  47  and rocker end  44  is engaged with hinge  45 . As illustrated in  FIG. 2 , hinges  45 ,  47  allow rocker  40  to pivot thereabout in order to be positioned between the storage position  43  and the deployed position  41  illustrated in phantom. Note that, as illustrated, portions of rocker  30  overlay portions of rocker  40  when rocker  30  and rocker  40  are positioned in the storage positions  33 ,  43 . In various implementations, rocker  30  and/or rocker  40  may be notched (not shown) or otherwise configured to cooperate with one another when positioned in the storage positions  33 ,  43 . In other implementations (not shown), rocker  30  may be generally separated from rocker  40  when rockers  30 ,  40  are positioned in the storage positions  33 ,  43 . 
     As illustrated in  FIG. 2 , foot rocker  110  includes foot support  120 , rocker  130 , and rocker  140 . Foot support  120  defines surface  123  ( FIGS. 5A and 5B ) adapted to engage at least portions of the plantar surface of the foot of the user. Rocker  130  and rocker  140  are engaged with the foot support  120 . In this implementation, rocker  130  is positionable between a deployed position  131 , which is illustrated in phantom in  FIG. 2 , and a storage position  133 . Rocker  140 , in this implementation, is positionable between a deployed position  141 , which is illustrated in phantom, and storage position  143 . Rocker  130  and rocker  140  support the foot support  120  above the surface  400  ( FIG. 1 ) when positioned in the deployed positions  131 ,  141 . Rocker  130  and rocker  140  have a generally curved form so that, when positioned in the deployed positions  131 ,  141  on surface  400 , rocker  130  and rocker  140  oscillate upon surface  400  in order to impart rocking oscillatory motion to the foot support  120 . 
     Foot support  120  of foot rocker  110 , as illustrated in  FIG. 2 , is formed to define a rim  122  generally about the periphery and foot support  120  defines surface  124 . The rim  122  in combination with the surface  124  of foot support  120  defines an open cavity  125  in this implementation. Rocker  130  and rocker  140  are hingedly secured to the foot support  120  and, when positioned in the storage position  133  and storage position  143 , respectively, rocker  130  and rocker  140  are generally disposed within the cavity  125  defined by the foot support  120 , as illustrated. Rocker end  136  of rocker  130  is engaged with hinge  137  and rocker end  134  is engaged with hinge  135  in this implementation. Hinges  135 ,  137  allow rocker  130  to pivot in order to be positionable between the storage position  133  and the deployed position  13   1  (illustrated in phantom). In this implementation, rocker end  146  of rocker  140  is engaged with hinge  147  and rocker end  144  is engaged with hinge  145 . Hinges  145 ,  147  allow rocker  140  to pivot in order to be positioned between the storage position  143  and the deployed position  141  (illustrated in phantom). 
     In the implementation illustrated in  FIG. 2 , a male fitting  80  extends forth from surface  24  of foot support  20  to engage with socket  170  on surface  124  of foot support  120  (see  FIG. 5C  for more detail). A male fitting  180  similar to male fitting  80  extends forth from surface  124  of foot support  120  to engage with socket  170 , which is similar to socket  70 , on surface  124  of second foot support  120  in this implementation. With rockers  30 ,  40 ,  130 ,  140  positioned in storage positions  33 ,  43 ,  133 ,  143 , male fitting  80  may be engaged with socket  170  and male fitting  180  may be engaged with socket  70  to releaseably secure foot rocker  12  and foot rocker  110  to one another with surface  24  and surface  124  oriented toward one another (see  FIGS. 5A and 5B ). Releaseably securing foot rocker  12  and foot rocker  110  to one another may facilitate transport and/or storage of apparatus  10 . In various other implementations, more or fewer male fittings  80 ,  180  and corresponding sockets  170 ,  70  may be provided. Other mechanisms (not shown) may be provided in other implementations to allow foot rocker  110  and foot rocker  12  to be releaseably secured to one another in various other implementations. 
       FIGS. 3A and 3B  illustrate by side view rocker  30  in the deployed position  31  and storage position  33 , respectively. As illustrated in  FIG. 3A , rocker  30  extends forth from cavity  25  defined by rim  22  and surface  24  of foot support  20  when positioned in the deployed position  31 . When rocker  30  is positioned in the storage position  33 , as illustrated in  FIG. 3B , rocker  30  is generally disposed within cavity  25 . Rocker  40 , when positioned in the storage position  43  ( FIG. 2 ) may be similarly disposed within cavity  25 , and rockers  130 ,  140  may be similarly disposed within cavity  125  when positioned in storage positions  133 ,  143  ( FIG. 2 ) in various implementations in order that foot rocker  12  and foot rocker  110  may be secured to one another. 
       FIGS. 4A and 4B  illustrate by top view and side cut-away view, respectively, portions of rocker  30  proximate exemplary hinge  35  with rocker  30  in the storage position  33 . Hinges  37 ,  45 ,  47 ,  137 ,  145 ,  147  may be generally similar to hinge  35 . As illustrated in  FIGS. 4A and 4B , pin  39  extends forth from rocker end  34  to engage hinge  35 . Rocker  30  may then be pivoted about pin  39  between the storage position  33  and the deployed position  31 . Pin  39  may be formed as a part of rocker  30 , for example, by molding in some implementations. In other implementations (not shown), the pin may be formed of metal or other suitable material separate from the rocker  30  and may be engaged with the rocker  30  and hinge  35 . The hinge  35  may be formed in other ways, as would be recognized by those of ordinary skill in the art upon study of this disclosure, to allow the rocker  30  to be positioned between the storage position  33  and the deployed position  31  in other implementations. 
       FIGS. 4C and 4D  illustrate by top view and side cut-away view, respectively, portions of rocker  30  proximate exemplary hinge  35  with rocker  30  in the deployed position  31 . As illustrated in  FIGS. 4C and 4D , pin  39  extends forth from rocker end  34  to engage hinge  35  to allow rocker  30  to be pivoted about pin  39  between the storage position  33  and the deployed position  3   1 . 
       FIG. 5A  illustrates foot rocker  12  secured to foot rocker  110  for transport and/or storage thereof. In this implementation, foot rocker  12  nests with foot rocker  110 . As illustrated, foot rocker  12  is sized with respect to foot rocker  110  such that foot rocker  12  may be partially received within cavity  125  defined by foot support  120  of foot rocker  110 . Surface  23  of foot support  20  and surface  123  of foot support  120  are oriented generally outward, as illustrated. Surface  123  engages the plantar surface of the foot when foot rocker  110  is utilized. Although not included in this Figure, rockers  30 ,  40 ,  130 ,  140  are contained in cavity  125  in this implementation when foot rocker  12  is secured to foot rocker  110 . Male fitting  80  may be engaged with socket  170  and male fitting  180  may be engaged with socket  70  in a similar fashion to releaseably secure foot rocker  12  and foot rocker  110  to one another in this implementation. In other implementations, other latches or suchlike may be provided to releasably secure foot rocker  12  to foot rocker  110 . 
       FIG. 5B  illustrates another implementation wherein foot rocker  12  is secured to foot rocker  110 . In this implementation, rim  22  of foot rocker  12  and rim  122  of foot rocker  110  are engaged with one another so that surface  24  is oriented toward surface  124  and cavities  25  and  125  are combined and rockers  30 ,  40 ,  130 ,  140  (not included in  FIG. 5B ) are contained therein. Male fitting  80  may be engaged with socket  170  and male fitting  180  may be engaged with socket  70  to releaseably secure foot rocker  12  and foot rocker  110  to one another. Various other latches or suchlike may be provided to releasably secure foot rocker  12  to foot rocker  110  in other implementations. 
       FIG. 5C  illustrates an implementation of male fitting  80  and socket  170 . As illustrated, male fitting  80  may be releasably received within socket cavity  177  defined by socket  170 . Various flanges, notches, and so forth may be provided about male fitting  80  and socket  170  to allow releasable engagement between male fitting  80  and socket  170 , as would be recognized by those of ordinary skill in the art upon study of this disclosure. 
     In operation, the apparatus for the prevention of venous thromboembolism generally in the foot and leg disclosed herein, for example apparatus  10 , may be utilized by positioning one or more rockers such as rocker  30  and rocker  40  engaged with a foot support such as foot support  20  from a storage position such as storage position  33  and storage position  43  into a deployed position such as deployed position  31  and deployed position  41  and then placing the foot rocker such as foot rocker  12  upon a surface. The user may then engage at least portions of a plantar surface of the user&#39;s foot with, for example, surface  23  of the foot support  21 . Either foot may be so engaged. The user may be seated, or the user may stand upon one foot—leg and engage the other foot and leg with the foot rocker  12 . When standing, the foot—leg not engaged with the foot rocker may bear most of the user&#39;s weight and stabilize the user while the apparatus  10  is employed. 
     The plantar surface of the foot may be engaged with surface  23  while shod so that a sole of a shoe or sandal or other footwear and, possibly, a sock are interposed between the plantar surface and surface  23  of the foot rocker  12  in some implementations. In other implementations, the bare plantar surface of the foot may directly engage the surface  23 , and in yet other implementations, the user may be stocking footed so that a sock is interposed between the plantar surface and surface  23 . With the plantar surface engaged with surface  23 , the foot of the user is then oscillated upon the foot rocker  12  in a rocking motion thereby delivering a stimulus to the foot and/or leg. The stimulus to the foot and leg may be delivered, at least in part, by dorsi flexion and plantar flexion of the foot caused by the rocking oscillation of the foot support with at least portions of the plantar surface of the foot engaged therewith. 
     Curved rockers such as rockers  30 ,  40  are generally unstable when placed upon surface  400  so that the foot rocker such as foot rocker  12  invites the oscillating rocking motion when the user&#39;s foot is applied thereto. The rocking motion with the plantar surface engaged with the surface  23  of foot rocker  12  may be continued for such time as a therapeutically effective stimulus for the prevention of venous thromboembolism is delivered to the user&#39;s foot and/or leg. The plantar surface of the foot may be engaged with the foot rocker such as foot rocker  12  periodically in order to stimulate repeatedly the foot and/or leg, for example during long period of inactivity, in order to maintain venous circulation in the foot and leg. 
     In various aspects, the user may employ a second foot rocker such as foot rocker  110  to stimulate the other foot and corresponding leg. For example, the user may use both foot rocker  12  and foot rocker  110  to stimulate both feet and legs simultaneously, or sequentially. In some aspects, the user may use a single foot rocker such as foot rocker  12  and may use the single foot rocker to stimulate both feet and legs sequentially. 
     When a second foot rocker is employed, such as foot rocker  110 , the foot rocker  110  may be detached from, for example, foot rocker  12 . With continuing exemplary reference to foot rocker  110 , following detachment, rocker  130  is positioned from the storage position  133  into the deployed position  131  and rocker  140  is positioned from the storage position  143  into the deployed position  141  and the rockers placed upon a surface such as surface  400 . The user, who may be seated, may then engage the plantar surface of the foot with the surface  123  of foot rocker  110  and stimulate the foot by oscillating the foot rocker  110  in a rocking motion. This may be done either simultaneously or sequentially with engagement with the other foot with, for example, surface  23  of foot rocker  12 . 
     Upon completion of delivery of the preventive therapy, rockers  30 ,  40  of foot rocker  12  may be positioned from the deployed positions  31 ,  41  into the storage positions  33 ,  43 . Rockers  130 ,  140  of foot rocker  110  may be positioned from the deployed positions  131 ,  141  into the storage positions  133 ,  143 . With rockers  30 ,  40  in storage positions  33 ,  43  and rockers  130 ,  140  in storage positions  133 ,  143 , foot rocker  12  and foot rocker may be releaseably engaged with one another, which may enhance the user&#39;s ability to transport and or store the apparatus  10 . In various aspects, foot rocker  12  and foot rocker  110  may nest with one another. 
     The foregoing detailed description discloses and describes various exemplary implementations. Upon study of the specification, one of ordinary skill in the art may readily recognize from the detailed description and from the accompanying figures and claims that various changes, modifications and variations can be made therein without departing from the spirit and scope of the inventions as defined in the following claims.