Note: Descriptions are shown in the official language in which they were submitted.
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IN THE UNITED STATES PATENT AND TRADEMARK OFFICE AS
RECEIVING OFFICE FOR THE PATENT COOPERATION TREATY (PCT)
SYSTEMS, DEVICES AND METHODS FOR MULTI-AXIAL ASSEMBLIES
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] The present application claims the benefit of U.S. Provisional
Application No.
63/139,248, filed January 19, 2021, entitled "SYSTEMS, DEVICES AND METHODS
FOR MULTI-AXIAL ASSEMBLIES", and is a continuation in part of U.S. Application
No. 17/350,621, filed June 17, 2021, entitled "MOUNTING BRACKET FOR
CONNECTING A PROSTHETIC LIMB TO A FROSTHETIC FOOT", and incorporates
the disclosure of all such applications by reference.
BACKGROUND
[0002] This disclosure relates generally to prosthetics for lower limb
amputees, and
more specifically to methods and apparatus for multi-axial assemblies to
provide rotation
and vertical movement to lower limb prostheses.
BRIEF SUMMARY
[0003] Multi-axial prosthesis assemblies that include a resilient closed
undulating
member are used to provide vertical and rotational movement for lower limb
prostheses.
A shaft is located through a resilient bumper, with a first prosthetic member
fixedly
attached to the shaft and engages a first surface of the undulating member,
and a second
prosthetic member comprises a lumen to movably receive the shaft. The
prosthetic
members are engaged to the resilient bumper with projections that are located
in the
recesses of the resilient bumper and the prosthetic members and the bumper are
configured
so that the projections from each member are offset from the projections of
the other
member, which results in an undulating appearance to the outer surface of the
resilient
bumper.
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[0004] In one embodiment, a prosthetic assembly is provided, comprising a
resilient
undulating body comprising an outer perimeter, a first surface, a second
surface opposite
the first surface, and an interior opening therebetween, a longitudinal shaft
located in the
interior opening of the undulating member, a first prosthesis body coupled to
the
longitudinal shaft and contacting the first surface of the undulating member,
and a second
prosthesis body comprising a longitudinal lumen and contacting the second
surface of the
undulating member, wherein the longitudinal shaft is movably located in the
longitudinal
lumen. The undulating body may comprise a first plurality of recesses on the
first surface
of the undulating body. The first prosthesis body may comprise a first
plurality of
projections configured to form a mechanical interfit with the first plurality
of recesses of
the undulating body. The undulating body may comprise a second plurality of
recesses on
the second surface of the undulating body. The second prosthesis body may
comprise a
second plurality of projections configured to form a mechanical interfit with
the second
plurality of recesses of the undulating body. The first plurality of recesses
may be
rotationally offset from the second plurality of recesses when no net
rotational forces are
acting on the undulating body. The first plurality of recesses may comprise an
equal
angular spacing relative to a central axis of the undulating body, and the
second plurality
of recesses may comprise an equal angular spacing relative to the central axis
of the
undulating body. The undulating body may further comprise an internal seal
extending
from the second surface of the undulating body that is radially offset from
the outer
perimeter of the undulating member and surrounding the interior opening of the
undulating
body. The angular spacing of the first plurality of recesses and the angular
spacing of the
second plurality of recesses may be 90 degrees. The first and second
pluralities of recesses
may be offset by 40 to 65 degrees. The first and/or second plurality of
recesses may each
comprise four recesses. Each recess of the first plurality of recesses and the
second plurality
of recesses may comprise an outer perimeter opening region, a radially inward
wall
opposite the outer perimeter opening, and opposing first and second side walls
flanking the
radially inward wall. The radially inward wall and the opposing first and
second walls may
comprise a U-shape on a transverse cross section through the undulating
member. The
recesses of the first plurality of recesses may further comprise a first
surface opening region
on the first surface of the undulating body, wherein the first surface opening
region is
contiguous with the outer perimeter opening region of the same recess, and a
middle wall
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opposite the first surface opening region, wherein the middle wall is flanked
by the first
and second walls of the same recess. Each of the recesses of the second
plurality of recesses
may further comprise a second surface opening region on the second surface of
the
undulating body, wherein the second surface opening region is contiguous with
the outer
perimeter opening region of the same recess, and a middle wall opposite the
second surface
opening region, wherein the middle wall is flanked by the first and second
walls of the
same recess. Each recess of the first and second pluralities of recesses
comprises a non-
planar surface opening. The first prosthesis body may be integrally formed
with the
longitudinal shaft. The second prosthesis body may be configured to permit
axial and
rotational movement of the longitudinal shaft in the longitudinal lumen of the
second
prosthesis body. The prosthetic assembly may further comprise a shaft retainer
removably
attached to the shaft, and may be configured to resist separation of the
longitudinal shaft
and the second prosthesis body. The shaft retainer may comprise a removable
fastener
configured to removably attach to the longitudinal shaft, an annular seal
configured to
slidably seal the shaft retainer to the second prosthesis body, and a
retaining washer with a
circumferential recess in which the annular seal partially resides. The shaft
retainer may
further comprise a spring. The spring may be configured to maintain
compression of the
resilient body when the prosthetic assembly is in an unloaded state. The
prosthetic
assembly may further comprise an attachment pyramid. The attachment pyramid
may be
integrally formed with the longitudinal shaft. The second prosthesis body may
further
comprise a mounting interface configured to attach to a foot prosthesis. The
mounting
interface may comprise a plurality of lumens, each lumen configured to
removably receive
a fastener. The plurality of lumens may be a plurality of transverse lumens.
The second
prosthesis body may further comprise an annular cavity to at least partially
receive the
undulating body. The diameter of the interior opening of the undulating body
may be
greater than a diameter of the longitudinal shaft located in the interior
opening of the
undulating body. The longitudinal shaft may comprise a transverse stop surface
located
between a first end and a second end of the longitudinal shaft, and configured
to
displaceably abut against a corresponding stop surface of the second
prosthesis body. The
prosthetic assembly may further comprise a compression collar located between
the first
and second prosthesis bodies and configured to limit displacement of the
longitudinal shaft
relative to the longitudinal lumen of the second prosthesis body.
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BRIEF DESCRIPTION OF THE DRAWINGS
[0005] These and other features, aspects and advantages of the present
invention will
become better understood with reference to the following description,
appending claims,
and accompanying drawings where:
[0006] FIG. 1A is a rear elevational view of a shock rotator assembly in
accordance with
exemplary embodiments of the present technology;
[0007] FIG. 1B is a side elevational view of the assembly in accordance with
exemplary
embodiments of the present technology;
[0008] FIG. 1C is a front elevational view of the assembly in accordance with
exemplary
embodiments of the present technology;
[0009] FIG. 1D is a top and view of the assembly in accordance with exemplary
embodiments of the present technology;
[0010] FIG. 1E is a bottom view of the assembly in accordance with exemplary
embodiments of the present technology;
[0011] FIG. 1F is a front perspective view of the assembly in accordance with
exemplary
embodiments of the present technology;
[0012] FIG. 1G is a rear perspective view of the assembly in accordance with
exemplary
embodiments of the present technology;
[0013] FIG. 1H is a side cross-sectional view of the assembly in FIG. 1B in
accordance
with exemplary embodiments of the present technology;
[0014] FIG. 2A is a top view of the resilient body of the assembly in FIGS. 1A
to 1G in
accordance with exemplary embodiments of the present technology;
[0015] FIG. 2B is a side view of the resilient body of the assembly in FIGS.
1A to 1G in
accordance with exemplary embodiments of the present technology;
[0016] FIG. 2C is a bottom view of the resilient body of the assembly in FIGS.
1A to
1G in accordance with exemplary embodiments of the present technology;
[0017] FIG. 2D is a top perspective view of the resilient body in accordance
with
exemplary embodiments of the present technology;
[0018] FIG. 2E is a cross-sectional view of the resilient body in accordance
with
exemplary embodiments of the present technology;
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[0019] FIG. 3A is a front perspective view the exemplary assembly in FIGS. 1A
to 1G
attached to an exemplary foot prosthesis in accordance with exemplary
embodiments of
the present technology;
[0020] FIG. 3B is a side elevational view the exemplary assembly in FIGS. 1A
to 1G
attached to an exemplary foot prosthesis in accordance with exemplary
embodiments of
the present technology;
[0021] FIG. 3C is a top view of the assembly and prosthesis combination in
FIG. 3A in
accordance with exemplary embodiments of the present technology;
[0022] FIG. 3D is a rear view of the assembly and prosthesis combination in
FIG. 3A in
accordance with exemplary embodiments of the present technology;
[0023] FIG. 3E is a front view of the assembly and prosthesis combination in
FIG. 3A
in accordance with exemplary embodiments of the present technology;
[0024] FIG. 4A is a rear view of the exemplary assembly in FIGS. 1A to 1G,
without
the resilient body in accordance with exemplary embodiments of the present
technology;
[0025] FIG. 4B is a side view of the exemplary assembly in FIGS. 1A to 1G,
without
the resilient body in accordance with exemplary embodiments of the present
technology;
[0026] FIG. 4C is a front view of the exemplary assembly in FIGS. 1A to 1G,
without
the resilient body in accordance with exemplary embodiments of the present
technology;
[0027] FIG. 4D is a cross-sectional view of the assembly in accordance with
exemplary
embodiments of the present technology;
[0028] FIG. 4E is a rear perspective view of the assembly in accordance with
exemplary
embodiments of the present technology;
[0029] FIG. 4F is a front perspective view of the assembly in accordance with
exemplary
embodiments of the present technology;
[0030] FIGS. 5A is a top plan view of the first housing in FIGS. 1A to 1G in
accordance
with exemplary embodiments of the present technology;
[0031] FIGS. 5B is a side plan view of the first housing in FIGS. 1A to 1G in
accordance
with exemplary embodiments of the present technology;
[0032] FIGS. 5C is a bottom plan view, respectively, of the first housing in
FIGS. 1A to
1G in accordance with exemplary embodiments of the present technology;
[0033] FIG. 5D is a cross-sectional view of the first housing FIG. 5B in
accordance with
exemplary embodiments of the present technology;
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[0034] FIG. 5E is a top perspective view of the first housing in accordance
with
exemplary embodiments of the present technology;
[0035] FIG. 5F is a bottom perspective view of the first housing in accordance
with
exemplary embodiments of the present technology;
[0036] FIG. 6A is a side elevational view of the shaft in FIGS. 1A to 1G in
accordance
with exemplary embodiments of the present technology;
[0037] FIG. 6B is a cross-sectional view of the shaft in accordance with
exemplary
embodiments of the present technology;
[0038] FIG. 6C is a top perspective view of the shaft in accordance with
exemplary
embodiments of the present technology;
[0039] FIG. 6D is a top plan view of the shaft in accordance with exemplary
embodiments of the present technology;
[0040] FIG. 6E is a bottom plan view of the shaft in accordance with exemplary
embodiments of the present technology;
[0041] FIG. 7A is a rear elevational view of the second housing in FIGS. 1A to
1G in
accordance with exemplary embodiments of the present technology;
[0042] FIG. 7B is a side elevational view of the second housing in FIGS. 1A to
1G in
accordance with exemplary embodiments of the present technology;
[0043] FIG. 7C front elevational view of the second housing in FIGS. 1A to 1G
in
accordance with exemplary embodiments of the present technology;
[0044] FIG. 7D is a cross-sectional view of the second housing FIG. 7B in
accordance
with exemplary embodiments of the present technology;
[0045] FIGS. 7E is a top perspective view of the second housing in accordance
with
exemplary embodiments of the present technology;
[0046] FIGS. 7F is a bottom perspective view the second housing in accordance
with
exemplary embodiments of the present technology;
[0047] FIG. 7G is a top plan view of the second housing in accordance with
exemplary
embodiments of the present technology;
[0048] FIG. 7H is a bottom plan view of the second housing in accordance with
exemplary embodiments of the present technology;
[0049] FIG. 8A is a top plan view of the retention washer in FIGS. 1A to 1G in
accordance with exemplary embodiments of the present technology;
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[0050] FIG. 8B is a side elevational view of the retention washer in FIGS. 1A
to 1G in
accordance with exemplary embodiments of the present technology;
[0051] FIG. 8C is a cross-sectional view of the retention washer in FIG. 7B
accordance
with exemplary embodiments of the present technology;
[0052] FIG. 8D is a bottom plan view of the retention washer in accordance
with
exemplary embodiments of the present technology;
[0053] FIG. 8E is a bottom perspective view of the retention washer in
accordance with
exemplary embodiments of the present technology;
[0054] FIG. 8F is a top perspective view of the retention washer in accordance
with
exemplary embodiments of the present technology;
[0055] FIG. 9 is a cross-sectional view of another embodiment of an assembly
comprising an integrated first housing and shaft in accordance with exemplary
embodiments of the present technology;
[0056] FIG. 10 is a cross-sectional view of another embodiment of an assembly
comprising a separate first housing and shaft in accordance with exemplary
embodiments
of the present technology;
[0057] FIG. 11A is a front elevational view of another embodiment of an
exemplary
shock rotator assembly in accordance with exemplary embodiments of the present
technology;
[0058] FIG. 11B is a side cross-sectional view of the assembly in FIG. 11A in
accordance with exemplary embodiments of the present technology;
[0059] FIG. 12A is a rear view of another embodiment of the assembly, shown in
FIG
11A and 11B, without the resilient body; in accordance with exemplary
embodiments of
the present technology
[0060] FIG.
12B is a cross-sectional view of the assembly in accordance with exemplary
embodiments of the present technology;
[0061] FIG. 12C is a rear perspective view of the assembly in accordance with
exemplary embodiments of the present technology;
[0062] FIG. 12D is a front perspective view of the assembly in accordance with
exemplary embodiments of the present technology;
[0063] FIG. 13A is a side elevational view of another embodiment of a shaft in
accordance with exemplary embodiments of the present technology;
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[0064] FIG. 13B is a cross-sectional view of the shaft in accordance with
exemplary
embodiments of the present technology;
[0065] FIG. 13C is a top perspective view of the shaft in accordance with
exemplary
embodiments of the present technology;
[0066] FIG. 13D is a top plan view of the shaft in accordance with exemplary
embodiments of the present technology;
[0067] FIG. 13E is a bottom plan view of the shaft in accordance with
exemplary
embodiments of the present technology;
[0068] FIGS. 14A is a rear perspective view of another embodiment of the
second
housing in accordance with exemplary embodiments of the present technology;
[0069] FIG. 14B is a top view of the second housing in accordance with
exemplary
embodiments of the present technology;
[0070] FIG. 15 is a perspective view of the second housing shown in FIGS. 14A-
B
showing the annular flange in accordance with exemplary embodiments of the
present
technology;
[0071] FIG. 16 is a perspective view of the first housing, shown in FIGS. 5A-D
and the
shaft shown in FIGS. 13A-13E in accordance with exemplary embodiments of the
present
technology;
[0072] FIG. 17 is a side perspective view of the second housing with a portion
of the
shaft placed within the lumen and the shaft in the neutral position in
accordance with
exemplary embodiments of the present technology;
[0073] FIG. 18 is a side perspective view of the second housing with a portion
of the
shaft placed within the lumen and the shaft rotated clockwise from in the
neutral position
in accordance with exemplary embodiments of the present technology; and
[0074] FIG. 19 is a side perspective view of the second housing with a portion
of the
shaft placed within the lumen and the shaft rotated counterclockwise from in
the neutral
position in accordance with exemplary embodiments of the present technology.
[0075] Elements and steps in the figures are illustrated for simplicity and
clarity and
have not necessarily been rendered according to any particular sequence. For
example,
steps that may be performed concurrently or in a different order are
illustrated in the figures
to help to improve understanding of embodiments of the present technology.
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DETAILED DESCRIPTION
[0076] The present technology may be described in terms of functional block
components and various processing steps. Such functional blocks may be
realized by any
number of components configured to perform the specified functions and achieve
the
various results. For example, the present technology may be used with a
prosthetic foot
for various amputation types (above knee, below knee, etc.). In addition, the
present
technology may be practiced in conjunction with any number of materials and
methods of
manufacture and the system described is merely one exemplary application for
the
technology.
[0077] While exemplary embodiments are described herein in sufficient detail
to enable
those skilled in the art to practice the invention, it should be understood
that other
embodiments may be realized and that logical structural, material, and
mechanical changes
may be made without departing from the spirit and scope of the invention.
Thus, the
following descriptions are not intended as a limitation on the use or
applicability of the
invention, but instead, are provided merely to enable a full and complete
description of
exemplary embodiments.
[0078] The function and features of a lower limb prosthetic may be selected
based on
the user's ability to ambulate and to transfer from various positions from a
chair or bed.
For patients that are able to ambulate at a single speed on level surface, a
solid ankle-
cushion heel foot prosthesis, or a single-axis prosthesis may be selected, for
users who are
able to traverse curbs, stair and uneven surfaces, a flexible-keel foot or a
multi-axial
ankle/foot prosthesis may provide improved ambulation efficiency and safety.
For users
with greater rehabilitation potential and are able to ambulate at different
speeds and
traverse most environmental obstacles, a multi-axial ankle foot with vertical-
loading pylon
may be beneficial.
[0079] In some
examples, a prosthetic assembly may be provided that permits limited
axial rotation and vertical loading between two housings in which a resilient
body is
located. The resilient body provides limited resilient vertical loading and
axial rotation as
it undergoes deformation by the relative displacement and motion between the
two
housings. A movable shaft is attached to one of the housings, and is
longitudinally and
rotationally movable relative to a lumen located in the other housing in which
the shaft
resides. A retention member or retention assembly may be provided at the end
of the shaft
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to releasably and movably retain the shaft in the other housing. The shaft is
typically a
rigid shaft that does not flex under typical loads, but in other embodiments,
the shaft may
comprise a resiliently flexible shaft with one or more bend regions, e.g.,
helical spring
region that can bend away from its central longitudinal axis.
[0080] To resist substantial separation of the resilient body from the
housings, the
resilient body may comprise a closed shape with an interior opening in which a
portion of
the shaft is located. To provide increasing resistance to greater degrees of
axial rotation,
the housings and the resilient body may comprise complementary projections and
recesses
configured to resist greater amounts of rotational slippage. The complementary
interface
may be sized and located to also distribute rotational forces acting on the
resilient body in
order to reduce the concentration of forces that may increase the fracture or
breakage of
the resilient body. In some further embodiments, the configuration of the
assembly may
include projections from the first and second housings into recesses located
in the resilient
body. The recesses may be located around the periphery of the resilient body
such that
each recess is open and confluent on both a side surface and a horizontal
surface of the
resilient body. The angular arrangement of the recesses may be configured such
that
recesses are located on alternating horizontal surfaces to receive alternating
projections
from the two housings. This results in an undulating configuration to the side
or periphery
surface of the resilient body. The resilient body may further comprise one or
more flanges
or sealing structures to help resist water or liquid intrusion into the
interior regions of
assembly.
[0081] The first and second housings of the assembly may also comprise
recesses or
cavities to partially contain a portion of the resilient body, and an
interface to fixedly or
movably couple to the shaft of the assembly. In some variations, a first or
upper end of the
shaft is configured to fixedly attach to the first or upper housing, so that
the first housing
and shaft move in a fixed relationship relative to the resilient body and
second housing. In
other variations, the first housing and shaft may be integrally formed.
Typically, the shaft
is inserted through the resilient body and into a longitudinal lumen of the
second or lower
housing in which the shaft movably resides.
[0082] The first or upper housing, or the first or upper end of the shaft, may
comprise an
attachment interface to attach to a pylon or residual limb socket. The second
or lower
housing may comprise an attachment interface to attach the assembly to a foot
prosthesis.
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[0083] The second or lower end of the shaft may be accessible at the second or
lower
end of the second housing, and a retention member or assembly may be attached
to the
shaft in order to retain the shaft in the lumen of the second housing. The
retention member
or assembly may be detached in order to perform maintenance on the assembly or
to change
out the resilient body.
[0084] In one exemplary embodiment as described generally above, a prosthetic
assembly 100 that provides vertical shock absorption and rotational movement
is depicted
in FIGS. 1A to 1H. The assembly 100 comprises a resilient bumper or body 102,
located
between a first or upper housing 104 and a second or lower housing 106. A
longitudinal
or vertical shaft 108 is coupled to the first housing 104, passing through the
resilient body
102 and coupled to the second housing 106. A retention member or retention
assembly
110 is attached to the shaft 108 to resist separation of the shaft from the
second housing
106. The assembly 100 is configured to permit limited longitudinal and
rotational
displacement of the shaft 108 relative to the second housing 106, with the
resilient body
102 providing increasing resilient resistance to increasing vertical
compression and
increasing rotational displacement. A pyramid attachment structure 112 is
provided on the
shaft 108 for attachment of the assembly 100 to a pylon or residual limb
socket (not shown),
while the second housing 106 is configured for attachment to a foot
prosthesis. A cover
piece 114 may also be provided on the assembly 100. In some variations, the
cover piece
114 may provide a cosmetic/trademark function and/or a protective function to
protect one
or more areas of the assembly 100 from intrusion of unwanted materials (e.g.,
dirt, liquid)
and/or inadvertent snagging of the assembly 100 with environmental objects and
hazards.
Although the assembly 100 described in this particular embodiment may be
provided
separate from a foot prosthesis, in other examples, the assembly 100 may be
integrated
with foot prosthesis at the point-of-manufacture.
[0085] The shaft 108 is sized to pass through a lumen 122 of the lower housing
106 such
that a retention member or retention assembly 110 may be used to releasably
retain the
shaft 108 in the lumen 122.
[0086] The resilient body 102 of the assembly 100 may comprise a resilient
material
such as silicone, rubber, polyurethane, urethane, thermoplastic elastomers,
thermoplastic
vulcanizates (e.g., SANTOPRENETm and ELASTRONTm), and the like. In some
further
embodiments, the resilient material may comprise a durometer in the range of
40A to 100A,
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or 50A to 90A or 60A to 90A, and may be selected based on the user's weight
and/or
activity level. In some examples, the resilient body 102 is selected to
provide up to 1 mm,
2 mm, 3 mm, 4 mm, or 5 mm or more vertical deflection or compression, and
selected to
provide up to 5 degrees, 6 degrees, 7 degrees, 8 degrees, 10 degrees, 12
degrees, 14 degrees,
16 degrees, or 20 degrees of rotational deflection, or more.
[0087] In one exemplary analysis, resilient bodies of various durometers were
evaluated
using various loads to achieve a minimum of 2 mm of vertical deflection and a
minimum
of 12 degrees of angular deflection. The results of the analysis are depicted
below as Table
1:
[0088]
Vertical Loads Torsion Loads
Resilient Static Vertical Actual
Body Test Deflection Down Rotation Angle ( )
Durometer Load Actual Force Force each
(shore A) (lbs) (inches) (lbs) (in-lbs) direction
64A 186 >.08 121 118 >12
70A 277 >.08 180 181 >12
77A 360 >.08 234 228 >12
83A 462 >.08 300 220 >12
[0089] In some examples, the density of the material of the resilient body may
be
different or lower inside the resilient body versus the exposed surfaces of
the resilient body,
or the exposed surfaces may comprise a different material. The resilient body
may also
comprise a coating, e.g. a hydrophobic or water-resistant coating to reduce
water
absorption into the resilient body.
[0090] As shown in FIGS. 1A to 1H, the upper housing 104 comprises a plurality
of
inferior projections 116 extending from its peripheral surface 118 and lower
surface 120.
The inferior projections 116 are located in and form a complementary interfit
with the
upper recesses 218 of the resilient body 102. Likewise, the lower housing 106
comprise a
plurality of superior projections 126 extending from its peripheral surface
130 and upper
surface 132, and are located in and form a complementary interfit with the
lower recesses
220 of the resilient body 102. The lower housing 106 further comprises an
attachment
interface 124 which is used to attach the assembly to a foot prosthesis (not
shown).
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[0091] Referring to FIGS. 2A to 2E, the resilient body 102 may comprise a
first or upper
surface 200, a second or lower surface 202, a central lumen 204 therebetween
defining an
inner surface 206, and an outer lateral surface 208. Each of the upper and
lower surfaces
200, 202 may comprise a generally planar configuration, but in other examples,
may
comprise a concave or convex configuration, or other non-planar configuration,
such as a
frustoconical configuration, or combination thereof. The central lumen 204 has
a generally
circular cross-sectional shape across its central longitudinal axis 210, but
in other variations
may comprise a triangular, square, rectangle, or oval shape, for example. The
diameter,
transverse dimension or surface area of the central lumen 204 may be constant,
or may
vary along the longitudinal axis 210. As depicted in exemplary resilient body
102 in FIG.
2E, the central lumen 204 may comprise a larger diameter about its upper and
lower regions
212, 214, but a smaller diameter about the middle region 216. In this example,
the
transitions along the regions 212, 214, 216 are gradual, such that the inner
surface 206
comprise a convex configuration on the cross-sectional view in FIG. 2E, but in
other
examples, the transitions may be abrupt, with a stepped surface configuration,
for example.
Similarly, the outer surface 208 of the resilient body 102 also comprises a
convex shape on
cross-section, but in other examples, may comprise a concave, linear,
frustoconical or other
shape. The larger diameter may be in the range of 0.4 inches to 3.0 inches,
0.6 inches to
2.0 inches or 0.8 inches to 1.3 inches. The smaller diameter may be in the
range of 0.20
inches to 2.8 inches, 0.4 inches to 1.8 inches or 0.7 inches to 1.2 inches,
and the average
diameter may be in the range of 0.3 inches to 2.9 inches, 0.5 inches to 1.9
inches or 0.75
inches to 1.25 inches. The central lumen 204 may be sized such that its inner
surface 206
is spaced apart and not in contact with the shaft 108 during typical usage. In
some
variations, some radially inward bulging of the inner surface 206 may be
expected during
vertical compression of the resilient body 102, and thus the dimension of the
central lumen
204 may be size sufficiently to reduce the likelihood that the inner surface
206 will contact
the shaft 108 during compression. The annular gap between the inner surface
206 and the
shaft 108 may be in the range of 0.001 inches to 1.0 inches, 0.02 inches to
0.5 inches or
0.03 inches to 0.25 inches. The average diameter or maximum transverse
dimension of the
resilient body 102 across opposite sides of the outer surface 208 may be in
the range of .7
inches to 3.5 inches, 1 inches to 2.5 inches or 1.5 inches to 2.25 inches.
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[0092] Referring still to FIGS. 2A to 2E, the exemplary resilient body 102
comprise a
set of upper recesses 218 and a set of lower recesses 220. The recesses in
each set of
recesses may comprise the same recess shape or configuration, and may be
equally spaced
apart, though between the upper recesses 218 and the lower recesses 220, the
angular
orientations are offset such that the angular position of each upper recess
218 is spaced
equally apart from the adjacent lower recesses 220, as is each lower recess
220 is spaced
equally apart from the adjacent upper recesses 218. In this example, each set
of recesses
218, 220 comprises four recesses that are spaced 90 degrees apart around the
resilient body,
and are offset by 45 degrees between the two sets of recesses 218, 220. This
permits the
resilient body 102 to be assembled or serviced without requiring a particular
angular
alignment or top/bottom orientation, which may simplify assembly and
replacement, and
may reduce premature wear. In other examples, however, the resilient body 102
may not
have such symmetry and therefore may be limited to a single or smaller number
of
positions/orientations. In other variations, for example, one or more recesses
may comprise
a different size, shape or spacing than the other recesses of the same set,
and/or the number
of recesses between the two sets of recesses may be different. In other
examples, the
number of recesses in each set of recess may be in the range of 2 to 5
recesses, 3 to 4
recesses, or 3 to 5 recesses.
[0093] Referring still to the recesses 218, 220 depicted in FIGS. 2A-2E, the
recesses
comprise openings 222, 224 that are angled or non-planar, with portions 222a,
224a of the
openings 222, 224 on the upper and lower surfaces 200, 202 of the resilient
body 102,
respectively, that are contiguous with portions 222b, 224b of the openings
222, 224 that
are located on the outer surface 208. Thus, each opening 222, 224 has a non-
planar
configuration with a boundary located on the outer surface 208 and either
upper or lower
surfaces, and where the different portions 222a, 222b, 224a, 224b are
generally orthogonal
to each other. In this particular embodiment, the recesses 218, 220 comprise
an inner wall
226, 228 such that the recesses 218, 220 do not open to the central lumen 204
of the resilient
body 102. This configuration may reduce the intrusion of debris or foreign
matter into the
device during use, which may interfere with smooth movement of the shaft 108
with the
lumen 204 of the lower housing 106. This configuration may also shift,
distribute or
transfer torque exerted by the upper and lower housings 104, 106 from the
inner regions to
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the outer regions of the resilient body 102, which will reduce torque forces
acting on the
resilient body 102 and may prolong its usable life being requiring
replacement.
[0094] Each of the recesses 218, 220 also comprise side walls 230, 232 and end
walls
234, 236. As shown in FIGS. 2A-2E, the transitions between the walls 226, 228,
230, 232,
234, 236 and with the upper and lower surfaces 200, 202 of the resilient body
102 may be
rounded rather than sharply angled. This may reduce the concentration of
forces
transferred from the lower and upper extensions of the upper and lower
housings 104, 106,
or otherwise distribute the transferred forces or stresses throughout the
resilient body 102,
which may reduce the risk of fracture or tearing, thereby extending the life
of the resilient
body 102. The height 238 of each recess 218, 220 may be characterized by as
the distance
between either upper or lower surfaces 200, 202 of the resilient body 102 to
the
corresponding end wall 234, 236, as best seen in FIG. 2B. The height 238 may
be in the
range of 0.1 inches to 3 inches, 0.2 inches to 1.5 inches or 0.3 inches to 1
inches. The
height 238 of each recess 218, 220 may also be characterized as a percentage
of the height
of the resilient body 102, e.g., the distance between the upper and lower
surfaces 200, 202.
In the particular embodiment depicted in FIG. 2B, each of the recesses 218,
220 have a
relative height 238 of 50% of the resilient body 102, each with an end wall
234, 236 at the
midplane 240 of the resilient body 102. In other variations, the recesses may
have a relative
height 238 in the range of 20% to 80%, 30% to 70%, 40% to 60%, or 50% to 70%,
for
example. The width 242 of each recess 218, 220 may be the average width or the
maximum
width based on the distance between the sidewalls, and may be in the range of
0.04 inches
to 1.5 inches, 0.125 inches to 1 inches or 0.15 inches to 0.5 inches. The
radial depth 244
of the recesses 218, 220 may be characterized by the distance between the
outer surface
208 and the inner walls 226, 228 of the recesses 218, 220, as depicted in FIG.
2C, and may
be in the range of 0.04 inches to 1.5 inches, 0.1 inches to 1 inches or 0.2
inches to 0.5
inches. In some variations, the width of each recess 218, 220 between the side
walls 230,
232 may be tapered in a radially inward direction, e.g., each side wall 230,
232 is located
in a plane intersecting the center longitudinal axis 210 of the resilient body
102. In other
variations, the angles of the side walls 230, 232 relative to the plane may
vary from about
1 to 5 degrees, 2 to 10 degrees, or 4 to 20 degrees, relative to the
plane intersecting
the center longitudinal axis 210, for example. In some further variations, the
angles of the
side walls 230, 232 may be altered such that the side walls 230, 232 are
parallel, or where
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the width of each recess 218, 220 is constant or increases toward the center
axis, so that
during rotation, the resilient member has a radial displacement force
component that drives
the resilient member towards the center line. This is in contrast to side wall
angles that
generate a radial outward displacement force from portions of the resilient
body 102 being
squeezed between, which may reduce the working life of the resilient member.
The radial
depth 244 of the recesses 218, 220 may also be characterized as a relative
percentage of
the radial or annular distance 246 between the inner and outer surfaces 206,
208 of the
resilient body 102, also depicted in FIG. 2C. The relative radial depth 244
may be in the
range of 30% to 90%, 40% to 80% or 50% to 80%, for example. The radial
thickness 248
of the inner walls 226, 228 may also be characterized as the radial distance
between the
inner walls 226, 228 and the inner surface 206 of the central lumen 204. The
radial
thickness 248 may be in the range of 0.04 inches to 2.0 inches, 0.07 inches to
1 inches or
0.1 inches to 0.5 inches, and may also be characterized as a relative
thickness 248 as a
percentage of the annular distance 246. The relative thickness 248 may be in
the range of
10% to 70%, 20% to 60%, or 20% to 50%, for example. These dimensions may be
measured based on the average dimension and exclude the curved regions of the
recesses
218, 220 at the transitions between different walls and surfaces.
[0095] FIGS. 5A to 5F depicts additional details of the upper housing 104 of
the
assembly 100 depicted in FIGS. 1A to 1H. As noted previously, the upper
housing 104
comprises a plurality of inferior projections 116 extending from its
peripheral surface 118
and lower surface 120. When assembled, the inferior projections 116 are
located in and
form a complementary interfit with the upper recesses 218 of the resilient
body 102. In
this exemplary embodiment, the peripheral surface 118 comprises a convex,
tapered shape
with a larger diameter or transverse dimension in the lower region 500 closer
to the inferior
projections 116 and lower surface 120, and a reduced diameter or transverse
dimension in
the upper region 502 of the upper housing 104. Because of the taper, the upper
surface 128
has a minimal or substantially reduced surface area as compared to the lower
surface 120.
In other variations of the upper housing 104, however, the peripheral surface
118 may not
be as tapered or may comprise a generally cylindrical in shape, or comprise a
non-circular
or polygonal shape with linear or vertically oriented surface.
[0096] The average length 506, average width 508 and average radial depth 510
of each
inferior projection 116 may be complementary to the sizes of the corresponding
recesses
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218. In some variations, the dimensions 506, 508, 510 of each inferior
projection 116 may
be slightly smaller or larger than the dimensions 238, 242, 244 of the
recesses 218. In
some examples, the inner surface 512 of each inferior projection 116 may have
a generally
vertical orientation or parallel orientation relative to the center
longitudinal axis 210 of the
upper housing 104. The outer surface 514 of each inferior projection 116 may
comprise a
taper that is in continuity with the taper and/or curvature of the peripheral
surface 118, and
may be flush, recessed, or protrude from the portion of the recess 218 on the
outer surface
208 of the resilient body 102. Like the recesses 218, the inferior projections
116 may
comprise rounded edges between the transitions of the lower surface 120, inner
surface
512, outer surface 514, and side walls 516 and end wall 518.
[0097] The upper housing 104 further comprises a central lumen 504 between the
lower
and upper surfaces 120, 128. The central lumen 504 is configured to receive
the
longitudinal shaft 108 of the assembly 100. As illustrated in FIG. 5D, the
central lumen
504 comprises a reduced dimension upper region 504a, and enlarged dimension
lower
region 504b, with a stepped surface 504c therebetween. The upper region 504a
may
comprise a threaded interface for attaching the shaft 108 to the upper housing
104, though
in the variations the lower region 504b or both regions 504a, 504b may
comprise threads,
or other type of mount (e.g. bayonet mount) may be provided between the upper
housing
and shaft. A glue, such as an acrylate or cyanoacrylate may also be added to
the threaded
interface, to resist decoupling from torsional forces acting through the
shaft.
[0098] As illustrated in FIGS. 1A to 1H and 6A to 6C, the pyramid attachment
structure
112 is provided on the shaft 108 for attachment of the assembly 100 to a pylon
or residual
limb socket. The pyramid 112 typically comprises an industry standard four-
sided
configuration, but in other examples, may comprise an alternative or
proprietary design.
The pyramid configuration may be changed by using a different shaft with a
different
pyramid configuration. Referring to FIGS. 6A to 6C, the pyramid 112 is located
at a first
end 600 of the shaft 108 and may include a threaded lumen 602 to facilitate
attachment of
the pyramid 112. Next to the pyramid 112 is an attachment region or interface
604 of the
shaft 108 that forms a complementary interfit with the central lumen 504 of
the upper
housing 104. This may be a threaded interface as depicted, or a bayonet mount
or other
type of mechanical interfit or friction fit as noted above. As depicted in
FIGS. 1A to 1H,
the shaft 108 may be configured such that when assembled with the upper
housing 104, the
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pyramid 112 protrudes from the upper surface 128 of the upper housing 104.
Adjacent to
the attachment interface 604 of the shaft 108 may be a tool interface 606,
which may be
used to grip the shaft 108 with a wrench or pliers or other tool when coupling
or decoupling
the shaft 108 and the upper housing 104. Although the tool interface 606
depicted in FIGS.
6A to 6C is a hexagonal interface, in other variations, the tool interface 606
may be square
or rectangular or other polygonal shape, or may comprise a lumen in which a
torque bar
may be inserted to facilitate rotational coupling and decoupling of the shaft
108 and upper
housing 104.
[0099] In still other variations of the assembly 900, the upper housing 902
and the shaft
904 and pyramid 906 may be integrally formed as a monolithic component, as
shown in
FIG. 9. In still other examples, as illustrated in FIG. 10, the assembly 1000
may comprise
a pyramid structure 1002 that is integrally formed with the upper housing 1004
of the
assembly 1000, but with a recess or lumen 1006 in the upper housing 1004 to
couple to a
shaft 1008. In this particular embodiment, the lumen 1006 of the upper housing
1004 is
open at both ends and is located through the pyramid 1002 and the main body
1008 of the
upper housing 1004, but in other variations, the lumen 1006 may be close-ended
and with
only a lower opening 1010 of the lumen, with the upper opening 1012 in the
pyramid 1002.
[0100] Referring back to FIGS. 6A to 6E, adjacent or inferior to the tool
interface 606
of the shaft 108 is the body 608 of the shaft 108, which is configured to
reside and move
in the lumen 122 of the lower housing 106 when assembled. The length of the
body 608
of the shaft 108 may be in the range of 1.0 inches to 7.0 inches, 2.0 inches
to 5.0 inches or
2.0 inches to 4.0 inches. The diameter or cross-sectional dimension of the
shaft 108 may
be in the range of 0.12 inches to 1.5 inches, 0.25 inches to 1.25 inches or
0.3 inches to 0.9
inches. Different lengths of the shaft 108 may also be provided in order to
accommodate
different patient preferences, height, and functional levels, with
corresponding different
heights of the resilient body 102.
[0101] The second or lower end 610 of the shaft 108 is sized and configured to
extend
out from the lumen 122 of the lower housing 106. A retention member or
assembly 110
may be attached to the second end 610 to resist pullout of the shaft 108 from
the lower
housing 106, but may be configured to permit some vertical displacement of the
shaft 108
within the lumen 122. This acts as a shock absorber as the upper housing 104
and lower
housing 106 resiliently compress the resilient body 102. In this particular
example, the
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retention assembly 110 is attachable to the second end 610 of the shaft 108 by
a closed
threaded lumen 612, but in other variations, may be attached via a clevis pin
or other
coupling interface. The retention assembly 110 is also configured to permit
the shaft 108
to rotate within the lumen 122 and thereby to permit axial rotation. In the
particular
examples depicted in FIGS. 1A to 1H, the axial rotation is limited by the
increasing
resistance to rotation provided by rotational compression of the resilient
body 102 between
the inferior and superior projections 116, 126. In other variations, however,
the retention
member or assembly 110, the shaft 108 and/or the lower housing 106 may be
configured
with one or more complementary flanges and recesses to provide a hard limit
angle limit
to the rotation range.
[0102] Referring now to the lower housing 106, which is detailed in FIGS. 7A
to 7H, as
noted previously, the lower housing 106 comprise a plurality of superior
projections 126
extending from its peripheral surface 130 and upper surface 132. The superior
projections
126 are positioned and configured to form a complementary interfit with the
lower recesses
220 of the resilient body 102. The lower housing 106 further comprises a
longitudinal
lumen 122 to receive the shaft 108. The lower housing 106 comprises a main
body 700 in
which the lumen 122 resides, and also includes the prosthesis attachment
interface 124
described earlier. The lumen 122 may include a lubricant or lubricious coating
to facilitate
longitudinal and rotational movement of the shaft 108 therein, but in some
examples, a
tubular bearing may be provided to facilitate such movement, such as a
SPRINGGLIDETM
bearing (St. Gobain; Courbevoie, France).
[0103] Like the inferior projections 116 of the upper housing 104, the average
length
704, average width 706 and average radial depth 708 of each superior
projection 126 may
be complementary to the sizes of the corresponding recesses 220 of the
resilient body 102.
In some variations, the dimensions 704, 706, 708 of each superior projection
126 may be
slightly smaller or larger than the dimensions 704, 706, 708 of the recesses
220. In some
examples, as depicted in FIG. 7C, the inner surface 714 of each superior
projection 126
may have a generally vertical orientation or parallel orientation relative to
the longitudinal
axis of the upper housing 104. The outer surface 716 of each superior
projection 126 may
comprise a taper that is in continuity with the taper and/or curvature of the
peripheral
surface 132, and may be flush, recessed, or protrude from the portion of the
recess 220 on
the outer surface 208 of the resilient body 102. Like the recesses 220, the
superior
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projections 126 may comprise rounded edges between the transitions of the
superior
surface 132 of the lower housing 106, and the inner surface 714, outer surface
716, side
walls 718 and end wall 720 of the superior projections 126.
[0104] The superior surface 132 of the lower housing 106 may comprise a
similar
configuration as the lower surface 120 of the upper housing 104 but with an
angular offset
to the projections 126. In the embodiment depicted in FIGS. 7A to 7E, however,
the
superior surface 132 further comprises an annular projection or flange 710.
The annular
flange 710 is spaced radially inward from the peripheral surface 130 and the
superior
projections 126, surrounding the longitudinal lumen 122 of the lower housing
106. This
flange 710 may be configured to insert or reside inside the central lumen 204
of the resilient
body 102. In some variations, the annular flange 710 may reduce the risk of
eccentric
displacement of the resilient body 102 during various compression and
rotational
movements, and may also limit the radially inward bulging of the inner surface
206 during
vertical compression, and/or may act as barrier reduce the intrusion of debris
and liquid
into the lumen 122 of the lower housing 106. The flange 710 also provides
additional
support for longer tubular bearings that might be used in the lumen 122. The
use of a longer
bearing may augment or reduce resistance that may be generated by off-axis
forces or
forces transverse to the longitudinal shaft and lumen. This may also improve
bearing life
and tactile prosthesis response. In embodiments comprising a tubular bearing,
the ratio of
the bearing length to the bearing inner diameter may in the range of 1.5:1 and
10:1, or 2:1
to 6:1 or 3:1 to 5:1. The flange 710 also allows the resilient member to be
placed lower in
the overall prosthesis, relative to the lumen 122, which can shorten the build
height of the
prosthesis, which allows the use of the prosthesis across a greater range of
residual limb
lengths. Depending on the height of the annular flange 710, the flange 710 may
also provide
a hard compression stop if the amount of vertical compression results in the
annular flange
710 abutting against the inferior surface 120 of the upper housing 104. In
some variations,
the height of the annular flange 710 is the range of 0.02 inches to 1.5
inches, 0.1 inches to
0.5 inches or 0.12 inches to 0.3 inches. The wall thickness of the flange 710
may be in the
range of 0.04 inches to 0.5 inches, 0.07 inches to 0.3 inches or 0.1 inches to
0.2 inches.
The inner diameter may be 0.25 inches to 1.5 inches, 0.3 inches to 1.0 inches
or 0.5 inches
to 0.75 inches, and the outer diameter may be 0.3 inches to 2.0 inches, 0.4
inches to 1.5
inches or 0.5 inches to 1.0 inches.
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[0105] The peripheral surface 130 of the lower housing 106 may also comprise a
convex,
tapered shape with a larger diameter or transverse dimension in the upper
anterior region
702. The attachment interface 124 of the lower housing 106 may comprise a
flat, vertically
planar surface to facilitate attachment of the lower housing 106 to a foot
prosthesis, but in
other variations, the lower housing 106 may comprise an angled or horizontal
region to
facilitate attachment to foot prostheses with a corresponding angled or
horizontal
attachment site.
[0106] The attachment interface 124 of the lower housing 106 comprise one or
more
threaded lumens 712 to facilitate attachment of the lower housing 106 to a
foot prosthesis
using screws, bolts or other fasteners. In FIGS. 3A to 3E, the assembly 100 is
attached to
a foot prosthesis 300 with a vertically mounted attachment interface, using
bolts 302, 304.
[0107] As depicted in FIG. 7A, the attachment interface 124 of the lower
housing 106
may also comprise cover attachment sites 722 which facilitate the attachment
of cosmetic
covers 114 to the body 700 of the lower housing 106. The lumen 122 of the
lower housing
106 may comprise a retention cavity 724 in which the retention assembly 110
resides. In
other variations, however, a retention cavity is not provided such that the
retention
assembly 110 may protrude from the lumen 122 and the lower housing 106.
[0108] As noted previously, the retention member or assembly 110 may be
attached to
the shaft 108 using the threaded lumen 612 at the lower end of the shaft 108,
as depicted
in FIG. 1H. The retention assembly 110 may comprise a bolt 800 or other type
of fastener,
and a retention washer 802 which is movable in the retention cavity 724. The
retention
washer 802 resists further upward displacement of the shaft 108 once it abuts
the superior
surface of the retention cavity 724. The retention washer 802 comprises a
washer cavity
804 to receive the bolt 800, and may include a reduced diameter shaft cavity
804a and an
enlarged head cavity 804b which allows the bolt 800 to have a recessed
position partially
in the retention washer 802 when attached to the shaft 108. To reduce the risk
of debris
and liquid interfering with the movement of the shaft 108 in the lumen 122 of
the lower
housing 106, an 0-ring or annular sliding seal 806 may be provided on the
retention washer
802. The seal 806 is maintained in a slidable arrangement with the retention
cavity 724 by
a seal recess 808 on the retention washer 802, bound by recess walls 808a and
808b, as
shown in FIGS. 8A to 8F. The retention washer 802 may also comprise a spring
recess
810 that is superior or proximal to the recess wall 808a. Referring back to
FIG. 1H, the
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spring recess 810 permits the positioning of a spring 812 which can be used to
provide
some limited inferior bias to the shaft 108 and may keep the resilient body
102 in a
minimum amount of compression to the assembly 100. This minimum compression
may
be useful if or as the resilient body 102 undergoes any permanent compression
or
compression set during use. The spring 812 may be a helical spring or a wave
washer, for
example. The seal 804 may comprise silicone, Buna-N rubber, and Fluorinated
elastomer
such as VITONTm (Chemours; Wilmington, DE).
[0109] FIGS. 4A to 4F illustrate the assembled configuration of the upper
housing 104,
lower housing 106 and shaft 108, without the resilient body 102. The shaft 108
may be
configured such that the tool interface 610 is located generally at the level
of the
longitudinal location of the resilient body 102. The gap or distance between
the lower
surface 120 of the upper housing 104 and the superior surface 132 of the lower
housing
106 may be equal to the unstrained height of the resilient body 102. In other
examples, the
gap or distance may be smaller than the unstrained height of the resilient
body 102, such
that when assembled, the upper and lower housings 104, 106 place the resilient
body 102
in vertical compression at baseline. This baseline compressed configuration
may make the
haptic feel of the assembly to be more linear or predictable compared to a
baseline
configuration that is not compressed or where the housing gap is greater than
the unstrained
height of the resilient body 102.
[0110] The upper housing 104, lower housing 106, shaft 108 and/or cover piece
114 may
comprise stainless steel (e.g. 17-4 stainless steel), titanium or cobalt
chromium, aluminum
or other metal, and anodized variants thereof, but in other examples may
comprise a rigid
polymer, ceramic or a composite thereof
[0111] In another exemplary embodiment, shown in FIG 11A and 11B, a prosthetic
assembly 1100 that provides vertical shock absorption and rotational movement
is depicted
in FIGS. 11A and 11B. The assembly 1100 comprises many components similar to
the
prosthetic assembly 100 described above and the similar components will not be
discussed
in detail below. The assembly 1100 comprises a resilient bumper or body 102,
located
between a first or upper housing 104 and a second or lower housing 1102. A
longitudinal
or vertical shaft 1104 is coupled to the first housing 104, passing through
the resilient body
102 and coupled to the lower housing 1102. A retention member or retention
assembly
110 is attached to the shaft 1104 to resist separation of the shaft 1104 from
the lower
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housing 1102. The assembly 1100 is configured to permit limited longitudinal
and
rotational displacement of the shaft 1104 relative to the lower housing 1102,
with the
resilient body 102 providing increasing resilient resistance to increasing
vertical
compression and increasing rotational displacement.
[0112] The shaft 1104 is sized to pass through a lumen 1106 of the lower
housing 1102
such that a retention member or retention assembly 110 may be used to
releasably retain
the shaft 1104 in the lumen 1106.
[0113] As illustrated in FIGS. 11A to 11B and 13A to 13E, the pyramid
attachment
structure 1108 is provided on the shaft 1104 for attachment of the assembly
1100 to a
pylon or residual limb socket. The pyramid 1108 typically comprises an
industry standard
four-sided configuration, but in other examples, may comprise an alternative
or proprietary
design. The pyramid configuration may be changed by using a different shaft
with a
different pyramid configuration. Referring to FIGS. 13A to 13E, the pyramid
1108 is
located at a first end 1110 of the shaft 1104 and may include a threaded lumen
1112 to
facilitate attachment of the pyramid 1108. Next to the pyramid 1108 is an
attachment
region or interface 1114 of the shaft 1104 that forms a complementary interfit
with the
central lumen 504 of the upper housing 104. This may be a collar interface as
depicted, or
a thread interface, as discussed above, a bayonet mount or other type of
mechanical interfit
or friction fit as noted above. As depicted in FIGS. 11A to 11B, the shaft
1104 may be
configured such that when assembled with the upper housing 104, the pyramid
1108
protrudes form the upper surface 128 of the upper housing 104. Adjacent to the
attachment
interface 1114 of the shaft 1104 may be a bore interface 1116, which may be
used to grip
the shaft 1104 with a wrench or pliers or other tool when coupling or
decoupling the shaft
1104 and the upper housing 104.
[0114] The bore interface 1116 may comprise at least one contact surface 1126
configured to contact the rounded lobes on the flange of the lower housing to
restrict
torsional rotation between the upper housing 104 and the lower housing 1102,
as will be
further discussed below. Although the contact surfaces 1126 depicted in FIGS.
13A to 13E
are a rectangular interface, in other variations, the contact surfaces 1126 of
the bore
interface 1116 may be square or hexagonal or other polygonal shape, or may
comprise a
lumen in which a torque bar may be inserted to facilitate rotational coupling
and decoupling
of the shaft 1104 and upper housing 104. The contact surfaces 1126 of bore
interface 1116
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on the shaft 1104 be configured to provide a hard limit angle limit to the
rotation range
with respect to the lower housing 1102 as shown in FIG. 18 and 19. The contact
surfaces
1126 may be configured in any suitable shaft to cooperate with the internal
configuration
of the flange of the lower housing 1102.
[0115] Referring back to FIGS. 13A to 13E, adjacent or inferior to the bore
interface
1116 of the shaft 1104 is the body 1118 of the shaft 1104, which is configured
to reside
and move in the lumen 1106 of the lower housing 1102 when assembled. The
length of
the body 1118 of the shaft 1104 may be in the range of 1.0 inches to 7.0
inches, 2.0 inches
to 5.0 inches or 2.0 inches to 4.0 inches. The diameter or cross-sectional
dimension of the
shaft 1104 may be in the range of 0.12 inches to 1.5 inches, 0.25 inches to
1.25 inches or
0.3 inches to 0.9 inches. In one embodiment, the diameter of the shaft may be
approximately 0.55 inches and the length of the body of the shaft may be
approximately
3.83 inches. Different lengths of the shaft 1104 may also be provided in order
to
accommodate different patient preferences, height, and functional levels, with
corresponding different heights of the resilient body 102.
[0116] The second or lower end 1120 of the shaft 1104 is sized and configured
to extend
out from the lumen 1106 of the lower housing 1102. A retention member or
assembly 110
may be attached to the second end 1120 to resist pullout of the shaft 1104
from the lower
housing 1102, but may be configured to permit some vertical displacement of
the shaft
1104 within the lumen 1106. This acts as a shock absorber as the upper housing
104 and
lower housing 1102 resiliently compress the resilient body 102. In this
particular example,
the retention assembly 110 is attachable to the second end 1120 of the shaft
1104 by a
closed threaded lumen 1122, but in other variations, may be attached via a
clevis pin or
other coupling interface. The retention assembly 110 is also configured to
permit the shaft
1104 to rotate within the lumen 1106 and thereby to permit axial rotation.
[0117] In the particular examples depicted in FIGS. 1A to 1H, the axial
rotation is
limited by the increasing resistance to rotation provided by rotational
compression of the
resilient body 102 between the inferior and superior projections 116, 126. In
other
variations, however, the retention member or assembly 110, the contact
surfaces of bore
interface on the shaft 108 and the rounded lobes on the flange of the lower
housing 106
may be configured to provide a hard limit angle limit to the rotation range.
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[0118] In the embodiment depicted in FIGS. 14A, 14B, and 15, the lower housing
1102
may comprise an annular projection or flange 1124. The remainder of the
components for
the lower housing 1102 are similar to those described above regarding lower
housing 106.
[0119] The annular flange 1124 is spaced radially inward from the peripheral
surface
130 and the projections 126, surrounding the longitudinal lumen 1106 of the
lower housing
1102. This flange 1124 may be configured to insert or reside inside the
central lumen 204
of the resilient body 102. In some variations, the annular flange 1124 may
reduce the risk
of eccentric displacement of the resilient body 102 during various compression
and
rotational movements, and may also limit the radially inward bulging of the
inner surface
206 during vertical compression, and/or may act as barrier reduce the
intrusion of debris
and liquid into the lumen 1106 of the lower housing 1102.
[0120] The flange 1124 also provides additional support for longer tubular
bearings that
might be used in the lumen 1106. The use of a longer bearing may augment or
reduce
resistance that may be generated by off-axis forces or forces transverse to
the longitudinal
shaft 1104 and lumen 1106. This may also improve bearing life and tactile
prosthesis
response. In embodiments comprising a tubular bearing, the ratio of the
bearing length to
the bearing inner diameter may in the range of 1.5:1 and 10:1, or 2:1 to 6:1
or 3:1 to 5:1.
The flange 1124 also allows the resilient member to be placed lower in the
overall
prosthesis, relative to the lumen 1106, which can shorten the build height of
the prosthesis,
which allows the use of the prosthesis across a greater range of residual limb
lengths.
Depending on the height of the annular flange 1124, the flange 1124 may also
provide a
hard compression stop if the amount of vertical compression results in the
annular flange
1124 abutting against the inferior surface 120 of the upper housing 104. In
some variations,
the height of the annular flange 1124 is the range of 0.02 inches to 1.5
inches, 0.1 inches
to 0.5 inches or 0.12 inches to 0.3 inches. The wall thickness of the flange
1124 may be in
the range of 0.04 inches to 0.5 inches, 0.07 inches to 0.3 inches or 0.1
inches to 0.2 inches.
The inner diameter may be 0.25 inches to 1.5 inches, 0.3 inches to 1.0 inches
or 0.5 inches
to 0.75 inches, and the outer diameter may be 0.3 inches to 2.0 inches, 0.4
inches to 1.5
inches or 0.5 inches to 1.0 inches. In one embodiment, the height of the
flange may be
approximately 0.47 inches and the outside diameter may be approximately 0.92
inches. In
one embodiment, the lobed design the flange 1124 wall thickness may be
irregular within
the range of 0.16 to 0.60 inches and the inside of the lobed feature has an
inscribed circle
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diameter of approximately 0.599 inches at minimum to approximately 0.800
inches at
maximum.
[0121] FIGS. 12A to 12D illustrate the assembled configuration of the upper
housing
104, lower housing 1102 and shaft 1104, without the resilient body 108. The
shaft 1104
may be configured such that the bore interface 1116 is located generally at
the level of the
longitudinal location of the resilient body 102. The gap or distance between
the lower
surface 120 of the upper housing 104 and the superior surface of the lower
housing 1102
may be equal to the unstrained height of the resilient body 102. In other
examples, the gap
or distance may be smaller than the unstrained height of the resilient body
102, such that
when assembled, the upper and lower housings 104, 1102 place the resilient
body 102 in
vertical compression at baseline. This baseline compressed configuration may
make the
haptic feel of the assembly to be more linear or predictable compared to a
baseline
configuration that is not compressed or where the housing gap is greater than
the unstrained
height of the resilient body 102.
[0122] Referring now to FIGS. 14 and 15 the flange 1124 may comprise an
internal bore
1128 having a plurality of rounded lobes 1130. The rounded lobes 1130 and the
contact
surfaces 1126 of the bore interface 1116 on the shaft 1104 are configured to
limit the
rotation of the upper housing 104 with respect to the lower housing 1102. The
rounded
lobes 1130 are spaced apart and located opposite of one another on the
internal bore 1128.
In one embodiment the internal bore 1128 may comprise four rounded lobes, that
are
configured to contact the four contact surfaces 1126 of bore interface 1116 on
the shaft
1104.
[0123] In various embodiments, the contact surfaces 1126 of bore interface
1116 on the
shaft 1104 and the rounded lobes 1130 on the flange 1124 of the lower housing
1104 may
be configured to provide a hard limit angle limit to the rotation range as
shown in FIG. 18
and 19. In one embodiment, the angle limit of rotation is approximately 15 in
the
clockwise and counterclockwise directions for a total range of rotation of
approximately
30 . In various embodiments, the number of contact surfaces 1126 of bore
interface 1116
on the shaft 1104 are the same as the rounded lobes 1130 on the flange 1124.
[0124] FIG 17 shows the lower housing 1102 with a portion of the shaft 1104
placed
within the lumen 1106 and the shaft 1104 in the neutral position. The contact
surfaces
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1126 of the bore interface 1116 are not in contact with the rounded lobes 1130
on the flange
1124 of the lower housing 1102.
[0125] FIG. 18 is a side perspective view of the lower housing 1102 with a
portion of
the shaft 1104 placed within the lumen 1106 and the shaft 1104 rotated
clockwise from the
neutral position. The contact surfaces 1126 of the bore interface 1116 are in
contact with
the rounded lobes 1130 on the flange 1124 of the lower housing 1102 to resist
torsional
rotation of the upper housing 104 attached to the shaft 1104 with regard to
the lower
housing.
[0126] FIG. 19 is a side perspective view of the lower housing 1102 with a
portion of
the shaft 1104 placed within the lumen 1106 rotated counterclockwise from the
neutral
position. The contact surfaces 1126 of the bore interface 1116 are in contact
with the
rounded lobes 1130 on the flange 1124 of the lower housing 1102 to resist
torsional rotation
of the upper housing 104 attached to the shaft 1104 with regard to the lower
housing.
[0127] The specific examples and descriptions herein are exemplary in nature
and
variations may be developed by those skilled in the art based on the material
taught herein
without departing from the scope of the present subject matter.
[0128] The technology has been described with reference to specific exemplary
embodiments. Various modifications and changes, however, may be made without
departing from the scope of the present technology. The description and
figures are to be
regarded in an illustrative manner, rather than a restrictive one and all such
modifications
are intended to be included within the scope of the present technology.
Accordingly, the
scope of the technology should be determined by the generic embodiments
described and
their legal equivalents rather than by merely the specific examples described
above. For
example, the steps recited in any method or process embodiment may be executed
in any
order, unless otherwise expressly specified, and are not limited to the
explicit order
presented in the specific examples. Additionally, the components and/or
elements recited
in any apparatus embodiment may be assembled or otherwise operationally
configured in
a variety of permutations to produce substantially the same result as the
present technology
and are accordingly not limited to the specific configuration recited in the
specific
examples.
[0129] Benefits, other advantages and solutions to problems have been
described above
with regard to particular embodiments; however, any benefit, advantage,
solution to
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problems or any element that may cause any particular benefit, advantage or
solution to
occur or to become more pronounced are not to be construed as critical,
required or
essential features or components.
[0130] As used herein, the terms "comprises," "comprising," or any variation
thereof,
are intended to reference a non-exclusive inclusion, such that a process,
method, article,
composition or apparatus that comprises a list of elements does not include
only those
elements recited, but may also include other elements not expressly listed or
inherent to
such process, method, article, composition or apparatus. Other combinations
and/or
modifications of the above-described structures, arrangements, applications,
proportions,
elements, materials or components used in the practice of the present
technology, in
addition to those not specifically recited, may be varied or otherwise
particularly adapted
to specific environments, manufacturing specifications, design parameters or
other
operating requirements without departing from the general principles of the
same.
[0131] Furthermore, in understanding the scope of the present invention, the
term
"comprising" and its derivatives, as used herein, are intended to be open
ended terms that
specify the presence of the stated features, elements, components, groups,
and/or steps, but
do not exclude the presence of other unstated features, elements, components,
groups,
and/or steps. The foregoing also applies to words having similar meanings such
as the
terms, "including," "having" and their derivatives. Any terms of degree such
as
"substantially," "about" and "approximate" as used herein mean a reasonable
amount of
deviation of the modified term such that the end result is not significantly
changed. For
example, these terms can be construed as including a deviation of at least 5%
of the
modified term if this deviation would not negate the meaning of the word it
modifies.
[0132] The present technology has been described above with reference to a
preferred
embodiment. However, changes and modifications may be made to the preferred
embodiment without departing from the scope of the present technology. These
and other
changes or modifications are intended to be included within the scope of the
present
technology, as expressed in the following claims.
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