AU782413B2 - Foot prosthesis having cushioned ankle - Google Patents

Description

AUSTRALIA

PATENTS ACT 1990 DIVISIONAL APPLICATION NAME OF APPLICANT(S): Van L. Phillips ADDRESS FOR SERVICE: DAVIES COLLISON CAVE Patent Attorneys 1 Little Collins Street Melbourne, 3000.

INVENTION TITLE: "Foot prosthesis having cushioned ankle" The following statement is a full description of this invention, including the best method of performing it known to me: FOOT PROSTHESIS HAVING CUSHIONED ANKLE The present invention relates to prosthetic feet and, more particularly, to a simply constructed, low-profile prosthetic foot having enhanced performance characteristics.

In the prosthetics market, the conventional SACH (solid-ankle, cushionheel) foot has been the most widely prescribed artificial foot over the past years. The SACH foot generally includes a solid ankle and cushioned heel foot mounted to a limb along an approximate hinge axis taken through the ankle. The SACH foot has been popular precisely for its simplicity, and thus economy, but S...includes certain drawbacks in terms of dynamic response characteristics.

Specifically, the low end SACH feet do not provide much energy storage and .release, as do more sophisticated prosthetic feet.

Most modem foot prostheses incorporate some form of energy storage element for storing and releasing walking energy. Conventionally, this might consist of a spring-loaded ankle joint comprising metal coil springs or, more commonly, rubber compliance members. Inexpensive foot prostheses have also been devised having essentially a solid rubber or foam ankle block for storing and 25 releasing walking energy. Such an ankle block has been disclosed in my issued patent titled PROSTHESIS WITH RESILIENT ANKLE BLOCK, U.S. Patent No. 5,800,569, the entirety of which is incorporated by reference. A solid, compressible ankle block may be secured between upper and lower support members to provide resilient compression and energy storage and release. The use of an ankle block member provides significant manufacturing and cost advantages.

However, for certain applications it is difficult to attain a desired level of spring compliance and energy return characteristics using a solid ankle block due to the P \OPERSASUa-.Jm 052U527399 2sp&doc-I6M 510 -2inherent limitations of the materials involved in terms of elasticity, viscosity and maximum compression.

Therefore, it would be desirable to provide an ankle block having selectable compliance and energy return characteristics that may be varied over a wider range to accommodate the different weight, height and activity levels of amputees.

According to one aspect of the present invention there is provided a prosthetic foot, comprising: a lower foot plate having a heel portion for contacting a ground surface during heel-strike; an upper ankle plate disposed generally over the lower foot plate and spaced therefrom along its entire length; and a resilient member disposed between the upper ankle plate and the lower foot plate; wherein energy storage and return characteristics of the resilient member are 15 adapted to be modified, to thereby provide the foot with variable stiffnesses; and the resilient member provides substantially the sole support between the foot plate and the ankle plate.

Also described is a simple, inexpensive prosthetic foot incorporating an ankle block with spring inserts. The ankle block is formed of compressible material having 20 desired compliance and energy return characteristics. The ankle block is sandwiched between a foot element and an ankle element. One or more spring inserts are embedded inside the ankle block to increase the rigidity of the prosthetic foot and to improve the degree of energy storage and return. The shape of the spring inserts is preferably one that supports compression during relative angular rotation of the ankle plate and foot plate elements, such as during toe and heel roll, and also vertical compression, such as in response to vertical shock loads.

A basic prosthetic foot may be provided having enhanced performance characteristics generally comprising a lower foot plate, an upper ankle plate, a foam ankle block joining the two plates, and a spring element embedded in the ankle block.

Both the foot plate and the ankle plate are constructed of strong, flexible material, preferably a laminate of composite material. The foot plate is sized approximately P.OPER\SAS'.J. 05\2527399 2 pa do-I W05105 -3equal to a human foot being replaced, while the ankle plate has a similar width, but has a shorter length than the foot plate. The ankle block has a length and width approximately equal to the ankle plate and is aligned therewith. The spring element comprises two relatively flat carbon fiber composite members secured at their middle and separated at their ends. This gives the spring element a preferable shape of a bowtie or double wishbone. Preferably, an attachment member couples the ankle plate to a stump or lower-limb pylon of the wearer. During walking, the combination of the resilient ankle block with the embedded spring element and flexible plates provides a smooth rollover from a heel-strike to a toe-off position.

The ankle block of a prosthetic foot may be provided with cylindrical openings both in the fore and aft positions of the ankle block. These openings enable the placement of additional inserts or stiffeners to give the block a desired rigidity. The foot element may also have a tapered thickness. Further, the foot element may comprise uplifted heel and toe ends and an arch region therebetween.

S15 In accordance with a further aspect of the present invention, there is provided a prosthetic foot, comprising: a lower foot plate having a length substantially equal to the length of a natural human foot, the foot plate including a heel portion and a toe portion; an upper ankle plate disposed generally over the lower foot plate and being not in direct contact with the lower foot plate; and a resilient member disposed between the upper ankle plate and the lower foot plate, a lower surface of the resilient member contacting an upper surface of the lower foot plate; wherein energy storage and return characteristics of the resilient member are adapted to be modified, to thereby provide the foot with variable stiffnesses.

In accordance with a still further aspect of the present invention, there is provided a prosthetic foot, comprising: a lower foot plate including a heel portion; an upper ankle plate disposed generally over the lower foot plate, the lower foot plate and the upper ankle plate being not in contact with one another; and a resilient member disposed between and in contact with both the upper ankle P JOPER\SASUo-IW 03\2527399 2.padoc-t6JSM -4plate and the lower foot plate; wherein energy storage and return characteristics of the resilient member are adapted to be modified, to thereby provide the foot with variable stiffnesses.

It is to be understood that not necessarily all the advantages described may be achieved in accordance with any particular embodiment of the invention. Thus, for example, those skilled in the art will recognize that preferred embodiments of the invention may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.

Preferred embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings, as set out below.

:FIGURE 1 is a perspective view of a prosthetic foot.

FIGURE 2 is a cross-sectional view of the prosthetic foot of FIGURE 1.

o.oo FIGURE 3 is a perspective view of the spring element embedded in the ankle block of the prosthetic foot.

FIGURE 4 is a side elevational view of the prosthetic foot more clearly showing a foot plate having a tapered thickness along its length.

S" FIGURE 5A is a sectional view of the prosthetic foot in a heel-strike position of a walking stride.

20 FIGURE 5B is a sectional view of the prosthetic foot in a flat position of a walking stride.

1FIGURE 5C is a sectional view of the prosthetic foot in a heel-off position of a walking stride.

FIGURE 5D is a sectional view of the prosthetic foot in a toe-off position of a walking stride.

FIGURE 6 is a cross-sectional view of an alternative prosthetic foot incorporating a modified spring element.

FIGURE 7 is a cross-sectional view of another alternative prosthetic foot incorporating a modified ankle block.

FIGURE 8 is a cross-sectional view of another alternative prosthetic foot incorporating a modified ankle block.

p \OPERVSANu-1- 052527399 2sp dow.I7iSA)S -4A- FIGURE 9 is a cross-sectional view of a prosthetic foot incorporating an inflatable bladder ankle block.

FIGURE 10 is a cross-sectional view of another prosthetic foot incorporating an inflatable bladder ankle block.

FIGURES 1 to 4, 5A to 5D, 9 and 10 illustrate embodiments of the present invention.

FIGURES 6 to 8 illustrate general features of differing types of a prosthetic foot, and should not be construed as falling within the scope of the present invention.

With reference to FIGURES 1 and 2, a first prosthetic foot 10 is shown in a perspective view and a cross-sectional side view, respectively. The prosthetic foot generally comprises a lower foot plate 12, an upper, smaller ankle plate 14, an ankle layer or block 16 made of resilient material, connecting the foot plate 12 to the ankle plate 14, and a spring element 18 embedded within the ankle block 16. The foot plate 12 has a length and width roughly equal to the approximate length and width of the particular Swearer's amputated foot and sized to fit within an outer, flexible cosmesis 30, shown in phantom. The ankle plate 14 and the resilient ankle block 16 have approximately the same horizontal cross-sectional size. The ankle plate 14, ankle block 16, and spring element 18 are centered transversely with respect to and are generally positioned over the back half of 20 the foot plate 12. The ankle block 16 is sandwiched between the foot plate 12 and the ankle plate 14 and is preferably glued or bonded to both plates using polyurethane 0 adhesive or other known securement technologies.

•o0°o The spring element 18 is a resilient support member inserted within the resilient ankle block 16. As shown in FIGURE 3, the spring element 18 is preferably comprised of upper and lower plate-like members 22 and 24, each of which is relatively flat and has a substantially rectangular vertical projection. These members are secured at their centre by a fastener 26 and separated at ends 80 and 82. The upper member 22 preferably has a curvilinear concave upward shape, while the lower member 24 preferably has a curvilinear concave downward shap. This gives the spring element 18 a substantially double wishbone or bowtie shape.

As shown in FIGURE 1, the spring element 18 is completely embedded within the ankle block 16 so as not to be visible from the outside. Referring to FIGURE 2, the spring element 18 extends substantially longitudinally across the length of the ankle block 16, and has a width substantially equal to the width of ankle block 16. The fastener 26 may comprise bolts, a weld, or any other fastening means as would be known to those skilled in the art. In the preferred embodiment, the fastener 26 is a strap which is laminated around the center portion of the two members 22, 24. A wedge member 28, preferably of a resilient elastomer, is placed between the two plate members 22, 24 to protect the inner surfaces of the members and to provide additional support to the spring element 18. The wedge 28 acts to provide leverage between the two plate members 22, 24, and enables adjustment of the flexing characteristics of the spring element 18, if desired. Alternatively, it may be bonded permanently in place or formed integrally with one or both of the plate members 22, 24, as desired. Although the spring element 18 has been described as having a double wishbone or bowtie configuration, other shapes and sizes may be appropriate for providing support to the ankle block 16. Furthermore, more than one spring element may be provided in the ankle block to provide support and energy return to the prosthetic foot As can be seen in FIGURES 1 and 2, the prosthetic foot 10 further comprises a pylon member 32 which can be secured to the stump of the amputee (not shown) and extends relatively downward therefrom in a generally vertical direction. The pylon member 32 in the preferred embodiment is of tubular construction having a substantially equal moment of inertia in all directions to restrict bending in all directions. The tubular member 32 is also preferably hollow so that it is relatively light in weight and utilizes less material which reduces the cost of production. The pylon member 32 is dimensioned so as to be interchangeable with a standard 30 mm pylon. Other configurations which impart rigidity, such as rectilinear cross sections having relatively larger moments of inertia about one or both transverse axes can also be utilized to obtain the benefits discussed herein. A centerline 70 through pylon 32, shown In FIGURE 1, defines the downward direction of the application of force.

As shown in FIGURES I and 2, the ankle plate 14 is secured to the pylon member 32 through a vertically oriented upper attachment member 34. The upper attachment member 34 is attached to a curvilinear ankle section 36, which is connected to the ankle plate 14. Preferably, these three pieces are monolitlically formed with one another for optimum strength and durability.. The attachment member 34 has a rearward surface 38, as shown in FIGURE 2, and a forward surface 40 substantially parallel thereto. The attachment member 34 is substantially rigid and capable of sustaining torsional, impact and other loads impressed thereupon by the prosthesis. In addition, the inherent rigidity of attachment member 34 prevents it from being distorted in any substantial way and causes the effective transmission of the aforesaid loads imposed thereupon to a suitable ancillary prosthetic pylon 32.

With reference to FIGURE 2, the attachment member 34 is vertically oriented so that it may be secured to the pylon member 32.

A coupling device 42 is positioned at the lower end of the pylon- member 32 which provides a flat surface upon which the vertical attachment member 34 can be secured. The coupling device 42 has one attachment surface 44 which mates with the cylindrical outer surface of the pylon member 32 and a second substantially flat attachment surface 46 which mates with the attachment member 34.

Attachment surface 44 is curved to mate with the outer surface of the tubular pylon member 32, and attachment surface 46 is flat to accommodate the forward surface 40 of the attachment member 34.

Desirably, the coupling device 42 is welded or bonded to the pylon member 32 and has two holes (not shown) into which two bolts 48 can be inserted and secured. The attachment member 34 also has two holes (not shown) which align with the holes on the coupling device to place and secure the two bolts 48 through the attachment member 34 and the coupling device 42. Other methods of securing the pylon member to the foot portion are contemplated, such as those disclosed in my prior issued U.S. Patent No. 5,514,186, the entirety of which is incorporated by reference, as well as those utilizing integrally formed constructions.

As stated, the attachment member 34 monolithically formed with the ankle plate 14 is vertically aligned so that it extends relatively downward from the coupling device 42 on the pylon member 32. As shown in FIGURE 2, the thickness of the attachment member 34 along this vertical section is relatively greater than the thickness of the ankle plate 14 substantially horizontally aligned along the foot portion. The attachment member 34 is also made relatively thicker to support the vertical load imposed on the prosthetic device as well as to restrict undue bending at this juncture. The entire upper vertically-aligned section of attachment member 34 is preferably of substantially uniform thickness and width.

The tubular pylon member 32 is preferably removable from the prosthetic device such that the pylon member can be replaced without replacing the remainder of the prosthetic device. This permits utilization of the device in a broader range of applications. For instance, the tubular member can be cut and adapted for use by amputees having different stump lengths including growing amputees. The prosthetist merely needs to cut a standard tubular pylon to the appropriate length. Moreover, this eliminates the *..need to manufacture as a part of the prosthesis a long rigid leg section. Thus, fewer materials are needed to manufacture the prosthesis of Applicant's invention resulting in reduced manufacturing costs.

The prosthetic foot 10 further comprises cylindrical slots or openings 50, 51 in the fore and aft portions of the ankle block 16, respectively, as shown in FIGURE 2, to accommnodate insertion of stiffeners 52, 53. The cylindrical openings 50, 51 are disposed horizontally in a direction generally transverse to a forward walking motion, and between upper and lower plate members 22 and 24.

25 Stiffeners 52, 53 can be removably placed in these openings to provide additional support and rigidity to the prosthetic foot 10, and also to modify the spring :characteristics of the prosthetic foot. For instance, additional energy storage and return can be provided for a more active amputee by inserting stiffeners 52, 53 into ankle block 16 having a higher spring constant. On the other hand, when more S 30 control is desired, stiffeners with a lower spring constant may be inserted to produce an ankle block 16 with greater dampening characteristics. Alternatively, the cylindrical openings 50, 51 may remain empty, thereby making the compliance characteristics dependent solely on the ankle block 16 and the spring element 18.

4 Both the foot plate 12 and the ankle plate 14 are preferably formed of a flexible material so that flexing of the plates tends to relieve extreme shear stresses applied to the interfaces between the ankle block 16 and the plates 12, 14. Both the foot plate 12 and the ankle plate 14 are preferably constructed of fiberglass which provides strength and flexibility. The preferred material for the ankle plate 14 and the foot plate 12 is a vinyl ester based sheet molding compound, such as Quantum #QC-8800, available from Quantum Composites of Midland, Michigan.

Alternatively, the plates may be formed by a plurality of lamina embedded in an hardened flexible polymer. In other arrangements, the plates may be formed of other materials such as carbon fiber composites as may be apparent to one skilled in the art. The desirable properties of the plates are that they are relatively resilient so as to withstand cracking upon application of repeated bending stresses yet have sufficient flexibility to enhance the performance characteristics felt by the wearer in conjunction with the properties of the resilient ankle block. The pylon member 32 is preferably made of a stiff material such as a laminate of fiber reinforced composite. Stiffness in the pylon member 32 can also be provided by a stiffer and more dense material.

The ankle block 16 is sandwiched between the foot plate 12 and the ankle plate 14 as shown in FIGURES 1 and 2 and is preferably bonded to both plates.

The ankle block is preferably formed of urethane, rubber or other suitable material having desired compliance and energy return characteristics. A preferred material for the ankle block is expanded polyurethane foam such as cellular Vulkolka* Pur- Cell No. 15-50, with a density of approximately 500 kg/m' as available from Pleiger Plastics Company of Washington, Pennsylvania. Alternatively, the ankle block 16 may be molded or fabricated from a wide variety of other resilient materials as desired, such as natural or synthetic rubber, plastics, honeycomb structures or other materials. Cellular foam, however, provides a high level of compressibility with desirable visco-elastic springiness for a more natural feeling stride without the stiffness drawbacks and limited compression associated with solid elastomeric materials. Furthermore, the cellular nature of a foam block makes it lighter than solid elastomers. Foam densities between about 150 and 1500 kg/m' may be used to obtain the benefits of the invention taught herein.

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OSTR -1 04 pF:\C The spring element 18 is preferably made from a highly resilient material that is capable of supporting compression during relative angular rotation of the upper and lower members 12 and 14, such as during toe and heel roll, and also vertical compression such as in response to vertical shock loads. One preferred material is carbon fiber composites such as woven fiber mats and chopped fiber in an epoxy matrix. However, other materials with similar strength and weight characteristics will be known to those skilled in the art and..may be used with efficacy. For instance, other filament types may be used, such as glass, Kevlar and nylon by way of example, to ensure lightweight and structural and dynamic characteristics consistent with the needs of a particular amputee. The wedge 28 may be fabricated from a wide variety of resilient materials, including natural and synthetic rubber, elastomeric polyurethane, or the like.

The ankle block 16 containing spring element 18 may be fabricated by injecting a polyurethane elastomer into a mold allowing it to cure. The spring element 18 may be inserted into the mold prior to injection of the polyurethane so that during curing, the polyurethane bonds to the spring member. Cylindrical slots or openings 50, 51 for insertion of stiffeners 52, 53 may be provided in ankle block 16 by inserting cylindrical plugs into the block prior to injection of polyurethane. Alternatively, openings may be provided in the block after curing o 20 simply by cutting or drilling away portions of the ankle block.

The stiffeners provided in the openings are preferably tubes of foam material having a density chosen according to desired compliance characteristics.

A preferable material is expanded polyurethane having a foam density between about 150 and 1500 kg/m 3 More preferably, a density of about 250 to 750 kg/m 3 25 is preferred to provide adequate adjustment of the energy storage and return characteristics of the foot.

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As illstrated in FIGURE 4, the foot plate 12 is preferably of curvilinear shape. The thickness t of foot plate 12 is preferably tapered along its length, and 0e 30 the tapered profile corresponds approximately to the weight of the amputee. That is, for a heavier amputee, the thicknesses along the length would be greater than for a lighter weight amputee. Generally, the weight groups may be classified as light, medium, or heavy.

Table I below presents preferred groupings, as module sizes C/D/E, of cosmesis sizes corresponding to a male width shoe last. The sizes are presented by length L, width B at the forefoot and width H at the heel of the cosmesis.

Table I. Cosmesis Sizes for Male Width Shoe Last MODULE LENGTH L (cm) WIDTH B WIDTH H (cm) (cm) 22 2.88 2.19 C 23 3.00 2.25 24 3.12 2.31 3.25 2.44 D 26 3.38 2.50 27 3.50 2.56 28 3.62 2.69 E 29 3.75 2.75 3.88 2.81 Table II below presents preferred module sizes for various weight groups of amputees.

Table II. Modules vs. Weight Groups MODULE WEIGHT

GROUP

LIGHT MEDIUM HEAVY C CL CM D DL DM DH E -EM EH Table III below presents preferred taper thicknesses for an average or "DM" size foot plate 12, taken at positions spaced by distance x 1 inch (2.54 cm).

C11 IC'1rim ME CUCCr 101 I C011 Table III. Taper Thickness t for DM Foot Plate POSITION (x 2.54 cm) THICKNESS t (cm) a 0.16 b 0.16 c 0.32 d 0.52 e 0.69 f 0.78 g 0.71 h 0.60 i 0.48 ,j 0.28 The foot plate 12 has a heel end 54, toward the left in FIGURE 4, which is concave-upward or slightly uplifted from a horizontal plane P, tangential to the heel end 54 of the foot plate 12. Similarly, a toe end 56, to the right of FIGURE 4, is concave upward or somewhat uplifted from a horizontal plane P, tangential to the front portion of the foot plate 12. An arch section 58 is formed between the heel and toe ends and is preferably concave-downward, as shown.

It is understood that within the cosmesis 30 (not shown), the tangent plane P, of the heel end 54 is slightly raised a distance y relative to the tangent plane P, of the toe end 56, as shown. The DM-sized foot plate of Table III, for example, has y 0.5 inches (1.27 cm). The foot plate 12 is preferably 0.25 inches (0.63 cm) from the bottom or sole of the cosmesis 30. The cosmesis 30 may be insert molded using an anatomically sculpted foot shape, with details and sizing based on a master pattern and/or digitized data representing typical foot sizes.

An intermediate region 58 comprising the arch portion of the foot plate 12 has the greatest thickness of the foot plate 12. The curvature of the arch region 58 is defined by the cosmesis or shoe sole profile, and generally corresponds to selected ranges of human foot lengths.

The foot plate 12 of prosthesis 10 preferably has a length between about and 15 inches (about 13 and 38 cm), more preferably between about 8 and 12 inches (about 20 and 30 cm) for the foot sizes given in Table 1. The width of foot -11- ^i err nI Ift1 ff Ii r eC plate 12 is preferably about 1 to 4 inches (about 2.5 to 8 cm). For the example given in Table III for a DM-sized foot plate 12, the length of the plate 12 is approximately 9 inches (about 23 cm) and its width is about 2 inches (about 5 cm).

The foot plate 12 has a thickness between about 0.05 and 0.4 inches (about 0.1 and 1 cm), which more preferably may be tapered as indicated in Table HIII.

The ankle plate 14 of prosthesis 10 is substantially planar, and is preferably shorter in length than the foot plate 12 and has a thickness also defined by the weight group of the wearer. The thickness of the ankle plate is preferably about 0.05 to 0.4 inches (0.1 to 1 cm). More preferably, the corresponding ankle plate 14 in the present example is about 0.2 inches (about 0.5 cm) thick at rear portion 62, tapering to a thickness of about 0.1 inches (about 0.25 cm) at front portion The ankle plate 14 preferably has a length of about 3 to 7 inches (about 8 to 18 cm) and a width of about 1 to 3 inches (about 2.5 to 8 cm), more preferably having length-width dimension of approximately 5 x 2 inches (about 13 x 5 cm).

The ankle plate 14 is positioned at an angle such that its front tip 60 is located closer to the foot plate 12 than its rear tip 68. Relative to plane P 3 shown in FIGURE 4, the rear tip is preferably raised an angle y of about 5 to 30 degrees, and more preferably, about 10 degrees.

The ankle block 16 is generally sized such that its upper surface is planar and corresponds to the length and width of the ankle plate 14. The lower surface of the ankle block 16 is substantially curvilinear to mate with the curvilinear surface of foot plate 12. In the present example, the block 16 has a preferred thickness, at its front 66, of about 1 to 3 inches (about 2.5 to 8 cm), more preferably about 1.3 inches (about 3.4 cm). Its thickness tapers to a minimum of about 0.5 to 1 inch (about 1 to 2.54 cm), more preferably about 0.8 inches (about 2 cm) adjacent arch portion 58. The rear 64 of the block 16 is preferably about 1 to 4 inches (about 2.5 to 10 cm) thick, more preferably about 2.6 inches (about 6.6 cm) thick, which is about twice the thickness of the front portion 66 of the block 16. This gives the ankle block a substantially wedge shape. The greater thickness at the rear of block 16 is provided to impart additional support in the rear portion 64 of the ankle block due to greater compressive forces on the rear of the foot prosthesis caused by off-axis application of force relative to axis 70 during heel strike (see FIGURE The ankle block 16 may be provided in varying heights or thicknesses, as desired, but is most effective with a thickness of between about 1 and 4 inches (about 2.54 and 10 cm). The front portion and rear surfaces of ankle block 16 are preferably angled according to the angle y defmined by the plane P 3 and the ankle plate 14. In other words, the ankle block has front and rear surfaces which are preferably sloped forward at an angle y from vertical. The ankle block thus provides a relatively stiff, yet flexible ankle region which can be customized for various wearers. Heavier wearers may require a denser resilient material for the ankle block, while lighter wearers may require a less dense material or less thickness.

As shown in FIGURES 2 and 3, the spring element 18 is positioned in the ankle block such that the center of the spring element 18, at the position of fastener 26, is located approximately above the arch portion 58 of foot plate 12.

The two members 22, 24 of the spring element 18 preferably have a constant thickness of about 0.05 to 0.2 inches (about 0.1 to 0.5 cm). The distance between the two members at front end 82, when no load is impressed onto the foot 10, is preferably about 0.5 and 2 inches (about 1 to 5 cm), more preferably about 0.7 inches (about 1.8 cm). At rear end 80, when no load is impressed on the foot the distance between members 22 and 24 is about 1 to 3 inches (about 2.5 to cm), more preferably about 1.4 inches (about 3.5 cm). As described in further detail below, when the foot is in a heel-strike position, the rear end 80 of the spring element is compressed. When the foot is in a toe-off position, the forward end 82 of the spring element is compressed.

The lengths, widths and thicknesses of the foot plate 12, ankle plate 14, ankle block 16 and spring element 18 may be customized for the wearer according to his/her foot size as well as the approximate weight group of the wearer.

Likewise, the material choice and size for these elements may be varied according to the wearer's foot size and weight.

The cylindrical openings 50, 51 provided in the fore and aft portions of ankle block 16 preferably have a diameter of about 0.1 to 0.4 inches (about 0.25 to 1 cm), and more preferably, about 0.2 inches (about 0.5 cm). While the openings 50 and 51 shown in FIGURE 2 have the same diameter, the diameters of the openings may be different to accommodate different sized stiffeners. For -13-

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instance, the diameter of opening 5 1 may be made larger than the diameter of opening 50 to correspond with the greater volume of ankle block 16 in rear portion 64.

To more fully explain the improved performance characteristics of the prosthetic foot 10, FIGURES 5A-5D) show "snapshots" of a prosthetic foot in several positions of a walking stride. More particularly, FIGURE 5A shows a heel-strike position, FIGURE 5B shows a generally flat or mid-stance position, FIGURE 5C shows a heel-off position, and FIGURE 51D shows a toe-off position.

Throughout the various positions shown for a walking stride, the present prosthetic foot 10 provides a smooth and generally life-like response to the wearer. During a walking stride, the ankle block 16 transmits the forces imparted thereon by the foot plate 12 and ankle plate 14, and experiences a gradual rollover, or migration of the compressed region, from rear to front.

With specific reference to FIGURE 5A, a first position of a walking stride generally entails a heel strike, wherein the :wea rer transfers all of his or her weight to the heel of the leading foot. In this case, a rear portion 54 of the foot plate 12 comes in contact with a ground surface 68, albeit through the cosmesis 30. The flexible nature of the foot plate 12 allows it to bend slightly in the rear portion 54, 20 but most of the compressive stresses from the weight of the wearer through the prosthetic foot 10 to the foot plate 12 are absorbed by a rear region 64 of the ankle block 16 with spring element 18. The spring element 18 in the rear portion contracts, such that the distance between members 22 and 24 at rear end decreases. In a front region 66 of the ankle block 16, the spring element 18 may expand slightly such that the distance between members 22 and 24 at front end 82 increases. Front portion 66 of the ankle block 16 experiences a stretching, or tension, due to the attachment along the entire lower edge of the ankle block with the foot plate 12, while rear portion 64 experiences compression. The contraction of the spring element 18 at end 80 and ankle block 16 at end 64 allows the 30 prosthesis 10 to absorb and store energy from the compressive stresses during heel strike. Further, a slight amount of bending may occur in a rear region 68 of the ankle plate 14. The rear stiffener 53 between members 22 and 24 is compressed so as to provide necessary support to the foot prosthesis and to prevent separation

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of the members 22, 24 from the wedge 28. Front stiffener 52 is slightly stretched substantially vertically due to the tension forces at front portion 66 of ankle block 16.

Next, in FIGURE 5B, the wearer reaches a generally flat-footed or midstance position, whereby the foot plate 12 contacts the ground 68 along substantially its entire length, again through the cosmesis 30. In this position the weight of the wearer is directed substantially downwardly, so that the compression along the length of the ankle block 16 is only slightly greater in the rear portion 64 than in front portion 66, due to the off-center application of force. In both the fore and rear ends of spring element 18, the members 22 and 24 are compressed towards each other, with the rear end 80 being slightly more compressed from its original position than the forward end 82. Likewise, stiffeners 52 and 53 are compressed due to the downward application of force. Although this view freezes the compressive stress distribution as such, in reality the weight of the wearer is continually shifting from behind the centerline 70 of the attachment member 34 to forward thereof. Thus, as the wearer continues through the stride, the compression of the ankle block 16 and the elements embedded within travels from the rear portion 64 toward the front portion 66. This migration of the compressed region can be termed "rollover." In a next snapshot of the walking stride, FIGURE 5C shows the prosthetic foot 10 in a "heel-off' position. This is the instant when the wearer is pushing off using ball 72 and toe 74 regions of the foot. Thus, a large compressive force is generated in the front region 66 of the ankle block 16, causing the rear region 64 to experience a large amount of separation or tension. Similarly, the spring element 18 at the rear end 80 expands between the two members 22, 24, while it compresses in the front end 82. The front tip 56 of the foot plate 12 may bend substantially to absorb some of the compressive stresses. Likewise, the front tip of the ankle plate 14 may bend somewhat at this point. It is important to note that although the ankle block 16 absorbs a majority of the compression generated by the wearer, the foot plate 12 and ankle plate 14 are designed to work in conjunction with the resilient ankle block and spring element and provide enhanced dynamic performance. Further, the flexing of the foot plate 12 and ankle plate 14 relieves some of the extreme shear stresses applied to the interfaces between the ankle block 16 and plates, thus increasing the life of the bonds formed therebetween. The stiffener 52 located in the front 66 of the ankle block 16 compresses so as to limit compression of front end 82, giving the wearer balance and to prevent separation of the members 22, 24 from the wedge 28. Stiffener 53 extends due to the separation of ankle block 16 in rear portion 64.

In FIGURE 5D, a final position of the walking stride is shown, wherein the prosthetic foot 10 remains in contact with the ground 68, but some of the weight of the wearer is being transferred to the opposite foot, which has now moved forward. In this "toe-off" position, there is less bending of the front tip 56 of the foot plate 12 and less compression of the front portion 66 of the ankle block 16 and front end 82 of spring element 18. Likewise, the front tip 60 of the ankle plate 14 may flex a slight amount, depending on the material and thickness utilized. The region of highest compression of the ankle block 16 remains at the farthest forward region 66, but it is reduced from the compression level of the heel-off position of FIGURE 5C. Thus, the rear portion 64 of the ankle block 16 experiences a small amount of tension or spreading.

:It can now be appreciated that the "feel" of the present prosthetic foot is gr!eatly. enhanced by the cooperation between the foot plate, ankle plate, ankle block and spring inserts. As the wearer continues through the walking stride the 20 dynamic response from the prosthetic foot is smooth as the ankle block with spring inserts compresses in different regions. Further, the flexing of the ankle and foot plates assist in smoothly transmitting the various bumps and jars found in uneven walking surfaces.

It will be appreciated that many alternatives of a prosthetic foot may also be constructed and used with efficacy. One such alternative is shown in FIGURE 6. Reference numerals for FIGURE 6 generally correspond to the reference numerals used in FIGURES 1-5D for like elements. Thus, the 30 prosthetic foot 10 shown in FIGURE 6 generally comprises a lower foot plate 12, an upper, smaller ankle plate 14, an ankle layer or block 16 made of resilient material, connecting the foot plate 12 to the ankle plate 14, and a spring element 18 embedded within the ankle block. The foot plate 12 has a length and width C -16-

SEC

A/T0,,~ roughly equal to the approximate length and width of the particular wearer's amputated foot and sized to fit within an outer, flexible cosmesis 30, shown in phantom. As shown in FIGURE 6, the ankle plate 14 has a substantially arcuate curvature extending from the integrally formed attachment member 34 to the front of the ankle plate 14.

More particularly, the spring element 18 as illustrated in FIGURE 6 is a resilient support member inserted within the resilient ankle block 16. The spring element 18 shown in FIGURE 6 is preferably a plate-like member with a curvilinear concave downward shape and a substantially rectangular vertical projection. The spring element 18 is preferably made from a carbon fiber composite material such as described hereinbefore, although other similar materials may be used as well.

FIGURE 7 illustrates another alternative prosthetic foot Again, like reference numerals are generally used to indicate like elements. Thus, the prosthetic foot 10 shown in FIGURE 7 generally comprises a lower foot plate 12, an upper, smaller ankle plate 14, and an ankle layer or block 16 made of resilient material, such as solid or foam rubber or polyurethane, and connecting the foot plate 12 to the ankle plate 14. The foot plate 12 has a length and width roughly equal to the approximate length and width of the particular wearer's 20 amputated foot and sized to fit within an outer, flexible cosmesis 30, shown in phantom. As shown in FIGURE 7, the ankle plate 14 transitions into a substantially arcuate or curved ankle section 36 which is preferably integrally formed between the attachment member 34 and the ankle plate 14.

FIGURE 8 illustrates yet another alternative prosthetic foot Again, like reference numerals are generally used to indicate like elements. Thus, the prosthetic foot 10 shown in FIGURE 8 generally comprises a lower foot plate S. 12, an upper, smaller ankle plate 14, and one or more ankle blocks 16a, 16b made of resilient material, such as solid or foam rubber or polyurethane, and connecting the foot plate 12 to the ankle plate 14. If desired, the posterior ankle block 16a 30 may have a density or compliance characteristic which is different than that of the anterior ankle block 16b, so as to render it more soft and more compliant, for example, than the anterior ankle block 16b. For instance, this configuration could provide a more compliant heel response during heel strike.

R A-17- T SEC o 104

D

b yf Ta a. 9* 9* Ankle blocks 16a, 16b may be formed integrally or separately, as desired or as expedient. Preferably, they are positioned closely adjacent to one another so as to occupy substantially the entire space between the foot plate 12 and the ankle plate 14. The foot plate 12 preferably has a length and width roughly equal to the approximate length and width of the particular wearer's amputated foot and sized to fit within an outer, flexible cosmesis 30, shown in phantom. As shown in FIGURE 8, the ankle plate 14 transitions into a substantially arcuate or curved ankle section 36 which is preferably integrally formed between the attachment member 34 and the ankle plate 14.

FIGURES 9 and 10 illustrate two embodiments of the invention. Again, like reference numerals are generally used to indicate like elements. Thus, the prosthetic foot 10 shown in FIGURE 9 generally comprises a lower foot plate 12, an upper, smaller ankle plate 14, and, in this case, an inflatable bladder 19 disposed between the foot plate 12 and the ankle plate 14.

The bladder 19 has the advantage in that it enables the patient or prosthetist Sto vary the. performance characteristics of the prosthesis by adjusting the pressure .in the bladder 19. This may be accomplished" for example, through the provision of a valve means 21, which is provided in communication with the bladder 19. In a preferred embodiment, the 20 valve 50 is adapted to receive a needle from an air pump (not shown) or from a

CO

2 cartridge (not shown), and may be suitably disposed on bracket 27, as illustrated in FIGURES 9 and 10. The valve 21 may be operatively connected to bladder via tubing or other suitable communication passage.

The bladder 19 may be secured via adhesive or other suitable affixing means to the upper ankle plate 14 and the lower foot plate 12 so as to provide substantially the sole means of connection and support therebetween. Optionally, one or more retaining straps 23 may be used to provide primary or secondary connection support, as needed or desired. Strap 23 may be fabricated from any number of suitably tough, flexible materials such as epoxy-impregnated canvas or the like. For example, straps 23 may be operatively attached to the forefoot portion of the prosthetic foot 10 as illustrated in FIGURE 9 via adhesive, or nuts and bolts, or may be releasably attached around the structural member 12, 14 through the provision of Velcro®-type fasteners or similar expedient.

a The straps 23 provide a number of benefits. For example, if juxtaposed to a bladder member 19, the strap may be appropriately tightened to 'flatten' the bladder, thus increasing the contact area between the structural members 12, 14 and the bladder. Moreover, restraining means such as the straps 23 may be incorporated to restrict the distance that the associated structural members 12, 14 may move from one another. The straps 23 may also be utilized to prevent undesirable excessive loading and stressing of the structural members 12, 14 and/or the bladder 19.

The bladder 19 is preferably fabricated from a suitably strong, flexible, leak-proof, lightweight material such as urethane or the like. By way of example, the bladder may be formed by heat sealing appropriately sized and shaped pieces of urethane sheet to each other. Suitable thicknesses of urethane sheet material have been found to be 0.01 to 0.02 inches (0.25 0.50 mm), but a wide range of suitable thicknesses and materials may also be utilized with efficacy. Bladder pressures of up to 80 psi (5.5 bar) have been utilized with efficacy.

The bladder 19 is preferably enwrapped in a covering material of Kevlar or similarly strong material to prevent the bladder 19 from exploding under high pressures and to help define the final inflated shape of the bladder. In preferred embodiments, a covering may include top and bottom sections which are stitched together at the perimeter 25 of the bladder 19. Those skilled in the art will understand that a variety of covering materials and methods of fabrication and assembly thereof may be also utilized with efficacy, without departing from the teachings of the invention.

Bladder 19 may enclose air, CO 2 or a similar gas-like substance, or may alternatively enclose liquids or gels such as water, silicone, or the like. Any such assembly is preferably selected and adjusted to provide the desired deformability and consequent 'cushioning' effect or energy-storing, absorption and release.

The bladder 19 may comprise a single chamber bladder, as illustrated in FIGURE 9, or, optionally, it may comprise a multiple chamber bladders with or without venting provided between adjacent chambers. For example, the bladder could be bifurcated into anterior and posterior chambers or portions 19a, 19b such that the posterior portion 19a can be adjusted to have a compliance characteristic which is different than that of the anterior portion 19b, so as to render it more soft and more compliant, for example, than the anterior portion. This may be desirable, for instance, to provide a more compliant heel response during heel strike. If desired or expedient, the bladder 19 may be tapered in shape so as to permit operative and proper alignment of the bladder between the ankle plate 14 and the foot plate 12.

Optionally, a spring element identical or similar to that illustrated and described above in connection with FIGURES 2-5, may be provided substantially completely within the bladder 19 (FIGURE 9) so as to provide primary or supplemental support between the foot and ankle plates, as desired. For, example, the spring element may comprise two relatively flat carbon fiber composite members secured at their middle and separated at their ends. This gives the spring element a preferable shape of a bowtie or double wishbone. During walking, the combination of the resilient spring element and inflatable bladder provides a smooth and adjustable rollover characteristic from a heel-strike to a toe-off, as desired.

The foot plate 12 preferably has a length and width roughly equal to the approximate length and width of the particular wearer's amputated foot and sized to fit within an outer, flexible cosmesis 30, shown in phantom. As shown in FIGURES 9 and 10, the ankle plate 14 transitions into a substantially arcuate or curved ankle section 36 which is preferably integrally formed between the attachment member 34 and the ankle plate 14.

Although this invention has been disclosed in the context of certain preferred embodiments and examples, it will be understood by those skilled in the art that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. Thus, it is intended that the scope of the present invention herein disclosed should not be limited by the particular disclosed embodiments described above, but should be determined only by a fair reading of the claims that follow.

P:OPERAIt3703902 spedoc-12/12J02 Throughout this specification and the claims which follow, unless the context requires otherwise, the word "comprise", and variations such as "comprises" and "comprising", will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps.

The reference to any prior art in this specification is not, and should not be taken as, an acknowledgment or any form of suggestion that that prior art forms part of the common general knowledge in Australia.

S

0S 0 P SEC la104 o

Claims (34)

1. A prosthetic foot, comprising: a lower foot plate having a heel portion for contacting a ground surface during heel-strike; an upper ankle plate disposed generally over the lower foot plate and spaced therefrom along its entire length; and a resilient member disposed between the upper ankle plate and the lower foot plate; wherein energy storage and return characteristics of the resilient member are adapted to be modified, to thereby provide the foot with variable stiffnesses; and the resilient member provides substantially the sole support between the foot plate •and the ankle plate.

2. The prosthetic foot of claim 1, wherein the foot plate has a length approximately 15 equal to the length ofa natural human foot. 0

3. A prosthetic foot as claimed in claim 1 or claim 2, wherein the foot plate and the resilient member flex in a cooperative manner to provide substantially smooth and oo. continuous rollover transition from heel-strike to toe-off. oooo 0

04. A prosthetic foot as claimed in any one of claims 1 to 3, wherein the foot plate element has a tapered thickness along its length, such that the thickness increases from a heel section to an arch section and decreases from the arch section to a toe section.

5. A prosthetic foot as claimed in any one of claims 1 to 4, wherein the lower foot plate and the upper ankle plate do not directly contact one another.

6. A prosthetic foot as claimed in any one of claims 1 to 5, wherein an upper surface of the resilient member is secured to a lower surface of the upper ankle plate, and a lower surface of the resilient member is secured to an upper surface of the lower foot plate. P \OPERVASU.-J.m 05US27399 Zp. do~-170MS5 22

7. A prosthetic foot as claimed in any one of claims 1 to 6, wherein the resilient member comprises a compressible bladder.

8. A prosthetic foot as claimed in claim 7, wherein the bladder has a wall thickness between 0.25 and 0.5 millimeters.

9. A prosthetic foot as claimed in claim 7 or claim 8, wherein the bladder encloses air, carbon-dioxide, liquids or gels.

10. A prosthetic foot as claimed in any one of claims 7 to 9, wherein the bladder comprises two or more chambers and wherein at least one of said chambers may be S. adjusted to have a compliance that is different than the compliance of at least one other S"chamber. 15 11. A prosthetic foot as claimed in any one of claims 7 to 10, wherein the bladder is made of urethane. S12. A prosthetic foot as claimed in any one of claims 1 to 6, wherein the resilient member comprises a relatively soft and compressible material. 0

13. A prosthetic foot as claimed in claim 12, wherein the resilient member comprises l: foam.

14. A prosthetic foot as claimed claim 13, wherein the resilient member comprises foam having a density between about 150 and 1500 kg/m 3 A prosthetic foot as claimed in any one of claims 12 to 14, wherein the resilient member further comprises at least one opening therein.

16. A prosthetic foot as claimed in claim 15, wherein a first and second cylindrical opening extend through the resilient member, the first opening being positioned in a fore P.\OPER\SAS'J=.Im 05\25273"99 2l.doct7J05M5 23 portion of the resilient member and the second opening being positioned in a rear portion of the resilient member.

17. A prosthetic foot as claimed in claim 16, wherein the resilient member further comprises at least one removable insert that is adapted to vary the stiffness of the resilient member.

18. A prosthetic foot as claimed in claim 17, wherein the at least one removable insert is received within one of the cylindrical openings.

19. A prosthetic foot as claimed in claim 17 or claim 18, wherein the at least one removable insert comprises foam having a density between about 150 and 1500 kg/m 3 :20. A prosthetic foot as claimed in claim 19, wherein the at least one removable insert comprises foam having a density between about 250 and 750 kg/m 3

21. A prosthetic foot, comprising: a lower foot plate having a length substantially equal to the length of a natural *'human foot, the foot plate including a heel portion and a toe portion; 20 an upper ankle plate disposed generally over the lower foot plate and being not in direct contact with the lower foot plate; and a resilient member disposed between the upper ankle plate and the lower foot plate, a lower surface of the resilient member contacting an upper surface of the lower foot plate; wherein energy storage and return characteristics of the resilient member are adapted to be modified, to thereby provide the foot with variable stiffnesses.

22. A prosthetic foot as claimed in claim 21, wherein the heel portion is adapted for contacting a ground surface during heel-strike.

23. A prosthetic foot as claimed in claim 21 or claim 22, wherein a rear portion of the upper ankle plate curves upwardly to define a substantially vertical attachment section. PAOPERISAS.m-. O05W2799 2 sr doc- 17)055 24

24. A prosthetic foot as claimed in any one of claims 21 to 23, wherein the resilient member comprises a compressible bladder.

25. A prosthetic foot as claimed in claim 24, wherein the bladder encloses air, carbon- dioxide, liquids or gels.

26. A prosthetic foot as claimed in claim 21, wherein the resilient member comprises a relatively soft and compressible material.

27. A prosthetic foot as claimed in claim 26, wherein the resilient member comprises 3333 foam.

28. A prosthetic foot as claimed in claims 26 or claim 27, wherein the resilient member 3 S' 15 further comprises at least one removable insert that is adapted to vary the stiffness of the *3 resilient member.

29. A prosthetic foot as claimed in claim 28, wherein the at least one removable insert 2 comprises foam having a density between about 150 and 1500 kg/m 3 3

30. A prosthetic foot as claimed in any one of claims 29, wherein the at least one 33 3 removable insert comprises foam having a density between about 250 and 750 kg/m 3

31. A prosthetic foot, comprising: a lower foot plate including a heel portion; an upper ankle plate disposed generally over the lower foot plate, the lower foot plate and the upper ankle plate being not in contact with one another; and a resilient member disposed between and in contact with both the upper ankle plate and the lower foot plate; wherein energy storage and return characteristics of the resilient member are adapted to be modified, to thereby provide the foot with variable stiffnesses. P \OPERWSASUm-J. 05X527399 2SW dom-17m5)5

32. A prosthetic foot as claimed in claim 31, wherein the heel portion is adapted for contacting a ground surface during heel-strike.

33. A prosthetic foot as claimed in claim 31 or claim 32, wherein a rear portion of the upper ankle plate curves upwardly to define a substantially vertical attachment section.

34. A prosthetic foot as claimed in any one of claims 31 to 33, wherein the resilient member comprises a compressible bladder. A prosthetic foot as claimed in claim 34, wherein the bladder encloses air, carbon- dioxide, liquids or gels. 4

36. A prosthetic foot as claimed in claim 31, wherein the resilient member comprises a 15 relatively soft and compressible material.

37. A prosthetic foot as claimed in claim 36, wherein the resilient member comprises foam. 20 38. A prosthetic foot as claimed in claims 36 or claim 37, wherein the resilient member further comprises at least one removable insert that is adapted to vary the stiffness of the resilient member. 4

39. A prosthetic foot as claimed in claim 38, wherein the at least one removable insert comprises foam having a density between about 150 and 1500 kg/m A prosthetic foot as claimed in claim 39, wherein the at least one removable insert comprises foam having a density between about 250 and 750 kg/m 3 P AOPER\SASUnJw 05U5273"9 2spidoc-i7JO90 26

41. A prosthetic foot substantially as hereinbefore described with reference to Figures 1 to 4, 5A to 51D, 9 and 10 of the accompanying drawings. Dated this 17th day of May, 2005 Van L. Phillips by DAVIES COLLISON CAVE Patent Attorneys for the applicant(s) :0066 .0 0* S 0