Abstract:
Various systems, apparatuses, and methods for producing a prosthetic foot by an additive manufacturing process are disclosed.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a divisional of U.S. patent application Ser. No. 14/214,842, filed on Mar. 15, 2014, which claims priority from U.S. Provisional Patent Application No. 61/801,118, filed on Mar. 15, 2013, which is incorporated by reference herein in its entirety. 
     
    
     BACKGROUND 
       [0002]    Various types of prosthetic feet currently exist and would be familiar to those of skill in the art. Generally, it is desirable to produce prosthetic feet that absorb energy during heel strike, and transfer the energy to the toe of the foot as the amputee&#39;s gait cycle progresses. Ideally, this energy is released at the moment of toe-off to provide energy for the next step. 
         [0003]    Active amputees who engage in sports or other strenuous physical activities typically require a prosthetic foot that is as efficient as possible at absorbing energy during heel strike and transferring the energy to the toe of the prosthetic foot for release at toe-off. Such prosthetic feet can be complex and expensive. Such prosthetic feet are also generally constructed from one or more spring-type plates that are connected by elastomeric or other materials and, therefore, do not typically resemble anything close to an actual human foot. 
         [0004]    In contrast to active amputees, amputees that are more sedentary may not require or want a prosthetic foot with such substantial or efficient energy storage and/or energy transfer capabilities. Alternatively, active or sedentary amputees may sometimes simply prefer to wear a prosthesis with a more lifelike foot or a lighter foot, even if that foot is less effective at storing and transferring energy during the amputee&#39;s gait cycle. Further, some amputees may simply prefer a more cost effective prosthetic foot. 
         [0005]    What is needed is a prosthetic foot that is easy to manufacture and is lower in cost than most prosthetic feet with high energy transfer efficiency. 
       SUMMARY 
       [0006]    In one embodiment, a prosthetic foot is provided, the prosthetic foot comprising: a primary foot member extending from a heel portion to a toe portion of the foot; a shock absorbing heel member extending downward from an underside of the primary foot member; at least one tendon extending from the heel member and connecting to a more forward portion of the primary foot member; and a connecting element extending upward from a top surface of the heel portion of the primary foot member; wherein at least the primary foot member, the heel member, and at least one tendon are a unitary structure produced by an additive manufacturing process. 
         [0007]    In another embodiment, a prosthetic foot is provided, the prosthetic foot comprising: a primary foot member extending from a heel portion to a toe portion of the foot; a shock absorbing heel member extending downward from an underside of the primary foot member; and at least one tendon extending from the heel member and connecting to a more forward portion of the primary foot member; wherein at least one of the primary foot member, the heel member, and at least one tendon are a unitary structure produced by an additive manufacturing process. 
         [0008]    In another embodiment, a prosthetic foot is provided, the prosthetic foot comprising: a primary foot member extending from a heel portion to a toe portion of the foot; a shock absorbing heel member extending downward from an underside of the primary foot member; at least one tendon extending from the heel member and connecting to a more forward portion of the primary foot member; and a connecting element extending upward from a top surface of the heel portion of the primary foot member, the connecting element comprising a plurality of grouped rods surrounded by an elastomeric band; wherein at least the primary foot member, the heel member, at least one tendon, and the plurality of grouped rods are produced by an additive manufacturing process. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]    The accompanying figures, which are incorporated in and constitute a part of the specification, illustrate various example apparatuses and systems, and are used merely to illustrate various example embodiments. 
           [0010]      FIG. 1  illustrates a perspective view of an exemplary embodiment of a prosthetic foot. 
           [0011]      FIG. 2  illustrates a front elevational view of an exemplary embodiment of a prosthetic foot. 
           [0012]      FIG. 3  illustrates a left elevational view of an exemplary embodiment of a prosthetic foot. 
           [0013]      FIG. 4  illustrates a rear elevational view of an exemplary embodiment of a prosthetic foot. 
           [0014]      FIG. 5  illustrates a right elevational view of an exemplary embodiment of a prosthetic foot. 
           [0015]      FIG. 6  illustrates a top elevational view of an exemplary embodiment of a prosthetic foot. 
           [0016]      FIG. 7  illustrates a bottom elevational view of an exemplary embodiment of a prosthetic foot. 
           [0017]      FIG. 8  illustrates a perspective view of an exemplary embodiment of a prosthetic foot inserted into a hollow cosmetic foot shell. 
       
    
    
     DETAILED DESCRIPTION 
       [0018]    Embodiments of the prosthetic foot are directed to a lightweight and cost-effective prosthetic foot that is produced by an additive manufacturing process. One exemplary embodiment of such a prosthetic foot  5  is illustrated by the various views of  FIGS. 1-7 . 
         [0019]    Additive manufacturing is a well-known technique for producing a variety of small and even large three dimensional objects, and is frequently utilized in rapid prototyping and rapid manufacturing applications. The objects created by an additive manufacturing process can be quite complex, even including objects trapped but freely moving within other objects. 
         [0020]    There are different types of additive manufacturing processes including, without limitation, stereo lithography (SLA), digital light processing (DLP), 3D printing, selective laser sintering (SLS), selective heat sintering (SHS), direct metal laser sintering (DMLS), electron beam melting (EBM), and fused deposition modeling (FDM). These various additive manufacturing processes collectively permit complex 3-D objects to be produced from numerous materials including, for example, photopolymers, paper, metals and metal alloys, plastics, and even edible materials. Regardless of the particular additive manufacturing process selected, however, additive manufacturing differs from typical machining processes in that additive manufacturing operates to produce a buildup of material rather than to remove material 
         [0021]      FIG. 1  illustrates a perspective view of a prosthetic foot  5 . Prosthetic foot  5  may be configured for use by a human amputee. Prosthetic foot  5  may be constructed using an additive manufacturing process.  FIGS. 1-7  illustrate various views of prosthetic foot  5 . 
         [0022]    An additive manufacturing process produced prosthetic foot  5  may include a primary foot member  10  that generally extends in length from a heel portion  15  to a toe portion  20 . Heel portion  15  of primary foot member  10  may be thicker than toe portion  20 , such that primary foot member  10  tapers from heel portion  15  to toe portion  20 . 
         [0023]    Primary foot member  10  may be contoured such that there is a downward slope when moving from heel portion  15  toward toe portion  20 . This contour may be selected, for example, to substantially mimic the arch of a human foot. Primary foot member  10  may be contoured around the edges, in toe portion  20 , or in other areas to replicate a human foot. Prosthetic foot  5  may be provided with a reduced top line in comparison to known prosthetic feet. This reduced top line may facilitate the donning and doffing of a shoe. 
         [0024]    Toe portion  20  of primary foot member  10  may be split for enhanced stability. Toe portion  20  of primary foot member  10  may be split to better control energy release at toe-off. In one embodiment, toe portion  20  of primary foot member  10  is split into two toe sections  25 ,  30 . One of two toe sections  25 ,  30  may be larger than the other. Toe portion  20  of other embodiments of primary foot member  10  may be split into a different number of toe sections and/or may be shaped to more closely mimic a human foot. 
         [0025]    Toe sections  25 ,  30  may be separated by a gap  35 . The size of gap  35  between toe sections  25 ,  30  may vary. In one embodiment, one or more connecting bands (not shown) may pass from one toe section  25  to the other toe section  30 , spanning gap  35  therebetween. Such connecting bands (not shown) may be used to limit deflection of toe portion  20  and/or toe sections  25 ,  30 . The connecting bands (not shown) may facilitate foot contact and stability. 
         [0026]    A heel member  40  may extend downward from the underside of primary foot member  10 . Heel member  40  may have a number of shapes and may be of various sizes. In one embodiment, heel member  40  may be substantially cylindrical in shape and may have a largely hollow interior that is bounded by a closed sidewall  45  of some thickness. A plurality of apertures  50  may pass through sidewall  45 . Apertures  50  may enhance the compressibility and shock absorbing characteristics of heel member  40 . Apertures  50  may take on any of a variety of shapes, and more than one shape may be present in a given heel member  40 . 
         [0027]    Heel member  40  may be formed as a hollow element having a wall in the form of a gapped spiraling or helical coil having an upper and lower terminus. That is, heel member  40  may resemble a partially uncoiled spring. The wall of heel member  40  may be similarly segmented to produce gapped vertical or angled cords or bands which, in some embodiments, may crisscross. Other designs are also possible, as long as the resulting heel member  40  is imparted with satisfactory shock absorbing characteristics. 
         [0028]    The shock absorbing properties of heel member  40 , and other heel member embodiments, may be further controlled by the introduction thereto of an additional elastomeric element(s). In one embodiment, heel member  40  may include an additional elastomeric element in the form of a bumper  55  (as illustrated in  FIGS. 3-5 and 7 ) that may be inserted into the interior of heel member  40  via an opening  60  located in the underside of heel member  40 . A lower end of bumper  55  may protrude slightly from the bottom of heel member  40  when bumper  55  is fully inserted thereto, such that bumper  55  may contribute to the shock absorbing characteristics of heel member  40  upon heel strike. Bumper  55  may protrude slightly from the bottom of heel member  40  and may contribute to the energy transfer characteristics of heel member  40  between heel strike and toe-off. 
         [0029]    A pair of tendons  65 ,  70  are shown to extend forward from heel member  40  and to connect with a more forward portion of primary foot member  10 . In one embodiment, as can be best observed in  FIG. 7 , tendons  65 ,  70  may connect with primary foot member  10  at a point just rearward of split toe sections  25 ,  30 . As illustrated in  FIG. 7 , one tendon  65  may be associated with one toe section  25 , and the other tendon  70  may be associated with the other toe section  30 . Tendons of other embodiments may connect to the associated primary foot member  10  at other locations thereon. 
         [0030]    Tendons  65 ,  70  are illustrated as having a substantially circular cross-sectional shape and having a particular contour. However, other tendons of other prosthetic foot embodiments may have other cross-sectional shapes and contours. In any case, tendons  65 ,  70  may be used to, for example, facilitate stability during ambulation by tying heel portion  15  of foot  5  to toe portion  20 , to limit toe deflection, and/or to produce a slightly earlier start to the plantar flexion stage of foot motion. 
         [0031]    A connecting element  75  extends upward from a top surface of heel portion  15  of primary foot member  10 . Unlike the remainder of prosthetic foot  5 , connecting element  75  may not be produced during the additive manufacturing process. Rather, connecting element  75  may be a separate component that is connected to primary foot member  10  subsequent to the additive manufacturing thereof. 
         [0032]    Connecting element  75  may function as an ankle to connect prosthetic foot  5  to the remainder of a prosthetic leg. Connecting element  75  may include a number of individual rods  80  that are grouped together to form a torsional pylon. Rods  80  may be of various cross-sectional shape, but are shown to be of substantially round cross-section in this exemplary embodiment. 
         [0033]    Rods  80  may each be connected at one end to primary foot member  10 . The size, number, and stiffness of rods  80  may be controlled in order to likewise control the stiffness of the torsional pylon (ankle). Flexion of the pylon may be further controlled by providing an elastomeric band  85  that encircles the group of rods  80 . The stiffness of elastomeric band  85  used may vary in order to provide greater control over pylon (ankle) stiffness. A proximal (free) end of rods  80  may be collected in a housing  90  or a similar element that facilitates connection of the pylon to a corresponding connecting element of a prosthetic leg. 
         [0034]    It should be understood that the entirety of prosthetic foot  5 , except for the connecting element  75 , may be produced as a unitary structure via use of an additive manufacturing process. In another embodiment, it is possible to form connecting element  75  by means of the additive manufacturing process. In another embodiment, at least one of primary foot member  10 , heel member  40 , and tendons  65 ,  70  are a unitary structure produced by an additive manufacturing process. 
         [0035]    The prosthetic foot  5 , absent connecting element  75 , may be produced by any of various possible additive manufacturing processes. Prosthetic foot  5  may be manufactured from a plastic material (e.g., nylon) using a selective laser sintering (SLS) additive manufacturing process. 
         [0036]    The use of an additive manufacturing process facilitates the production of custom prosthetic feet. For example, an amputee&#39;s existing foot could be scanned and mirrored and then used as a model for an additive manufacturing produced prosthetic foot. Alternatively, various off-the-shelf (i.e., non-custom) prosthetic feet could be produced with a given foot covering some range of shoe sizes (e.g., size 6-8, size 9-11, etc.). Still alternatively, a different foot could be produced for each shoe size while still being an off-the-shelf foot. Still further, it is also possible to produce a prosthetic foot whose length may be reduced by easily trimming away material to produce a foot of given shoe size. Such a foot may have trimming indications for this purpose. 
         [0037]    As illustrated in  FIG. 8 , a separate hollow foot shell  95  may be placed on, over, or otherwise connected to, the additive manufacturing produced portion of prosthetic foot  5  to create a multi-piece prosthetic foot with a further improved cosmetic appearance. In one embodiment, by means of for example a 3-D printing process a prosthetic foot may be produced as described above within an outer foot shell that is more anatomically correct. The foot shell in such an embodiment may be only minimally connected to the internal foot structure so as to keep the foot shell in place thereon. 
         [0038]    To the extent that the term “includes” or “including” is used in the specification or the claims, it is intended to be inclusive in a manner similar to the term “comprising” as that term is interpreted when employed as a transitional word in a claim. Furthermore, to the extent that the term “or” is employed (e.g., A or B) it is intended to mean “A or B or both.” When the applicants intend to indicate “only A or B but not both” then the term “only A or B but not both” will be employed. Thus, use of the term “or” herein is the inclusive, and not the exclusive use. See Bryan A. Garner, A Dictionary of Modern Legal Usage 624 (2d. Ed. 1995). Also, to the extent that the terms “in” or “into” are used in the specification or the claims, it is intended to additionally mean “on” or “onto.” To the extent that the term “substantially” is used in the specification or the claims, it is intended to take into consideration the degree of precision available or prudent in manufacturing. To the extent that the term “selectively” is used in the specification or the claims, it is intended to refer to a condition of a component wherein a user of the apparatus may activate or deactivate the feature or function of the component as is necessary or desired in use of the apparatus. To the extent that the term “operatively connected” is used in the specification or the claims, it is intended to mean that the identified components are connected in a way to perform a designated function. As used in the specification and the claims, the singular forms “a,” “an,” and “the” include the plural. Finally, where the term “about” is used in conjunction with a number, it is intended to include ±10% of the number. In other words, “about 10” may mean from 9 to 11. 
         [0039]    As stated above, while the present application has been illustrated by the description of embodiments thereof, and while the embodiments have been described in considerable detail, it is not the intention of the applicants to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art, having the benefit of the present application. Therefore, the application, in its broader aspects, is not limited to the specific details, illustrative examples shown, or any apparatus referred to. Departures may be made from such details, examples, and apparatuses without departing from the spirit or scope of the general inventive concept.