U.S. patent application number 14/856267 was filed with the patent office on 2016-01-07 for modular prosthetic sockets and methods for making same.
The applicant listed for this patent is LIM INNOVATIONS, INC.. Invention is credited to Garrett Ray HURLEY, Jesse Robert WILLIAMS.
Application Number | 20160000587 14/856267 |
Document ID | / |
Family ID | 48281375 |
Filed Date | 2016-01-07 |
United States Patent
Application |
20160000587 |
Kind Code |
A1 |
HURLEY; Garrett Ray ; et
al. |
January 7, 2016 |
MODULAR PROSTHETIC SOCKETS AND METHODS FOR MAKING SAME
Abstract
The invention relates to a prosthetic socket for a residual limb
of the lower extremity or upper extremity of an individual person.
The residual limb has particular dimensions and anatomical
contours; the prosthetic socket has dimensions and contours that
fit the dimensions and contours of the residual limb. The
prosthetic socket may also fit in a manner that is biomechanically
particularly appropriate for the individual. The prosthetic socket
is an assembly of components from groups of components that include
(a) struts arranged longitudinally with respect to the residual
limb, (b) proximal brim members arranged proximally to the struts
and connected thereto; and (c) distal socket members disposed at
the distal base of the prosthetic socket. The socket components
within these groups may be modular in that they can vary with
respect to dimensions and/or contours, and yet have common
connecting features that permit assembly of the components together
to form the prosthetic socket.
Inventors: |
HURLEY; Garrett Ray; (San
Francisco, CA) ; WILLIAMS; Jesse Robert; (San
Francisco, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
LIM INNOVATIONS, INC. |
San Francisco |
CA |
US |
|
|
Family ID: |
48281375 |
Appl. No.: |
14/856267 |
Filed: |
September 16, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14659433 |
Mar 16, 2015 |
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14856267 |
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13675761 |
Nov 13, 2012 |
8978224 |
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14659433 |
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61559051 |
Nov 12, 2011 |
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Current U.S.
Class: |
623/35 ; 623/33;
623/36 |
Current CPC
Class: |
A61F 2/78 20130101; A61F
2/7812 20130101; A61F 2/5046 20130101; A61F 2230/0067 20130101;
A61F 2002/546 20130101; A61F 2002/5027 20130101; A61F 2002/5083
20130101; A61F 2/60 20130101; A61F 2230/0095 20130101; A61F
2002/503 20130101; A61F 2/5044 20130101; A61F 2002/5026 20130101;
Y10T 29/49826 20150115; A61F 2/54 20130101; A61F 2002/785 20130101;
Y10T 29/4978 20150115; A61F 2/80 20130101 |
International
Class: |
A61F 2/80 20060101
A61F002/80; A61F 2/60 20060101 A61F002/60 |
Claims
1. A modular prosthetic socket for a residual limb of a lower
extremity of a patient, the modular prosthetic socket comprising:
multiple longitudinal struts arranged longitudinally with respect
to the residual limb, each strut having a distal end and a proximal
end; a distal attachment member coupled with the distal ends of the
four struts; a proximal brim coupled with the four struts at or
near their proximal ends; at least one sensor coupled with at least
one of the struts, the distal attachment member or the proximal
brim, for sensing at least one of a force, a torque, a load or a
pressure applied to at least one portion of the prosthetic socket
by the residual limb; and a microprocessor operably coupled with
the at least one sensor for processing data sensed by the at least
one sensor.
2. The modular prosthetic socket of claim 1, further comprising an
adjustment mechanism coupled with the microprocessor to adjust the
prosthetic socket according to instructions provided by the
microprocessor.
3. The modular prosthetic socket of claim 2, wherein the adjustment
mechanism comprises a rotary tensioning mechanism and a tensioning
cable for tightening and loosening the modular prosthetic socket,
and wherein the microprocessor is directly coupled with the rotary
tensioning mechanism.
4. The modular prosthetic socket of claim 3, wherein the
microprocessor and the rotary tensioning mechanism are coupled with
one of the struts.
5. The modular prosthetic socket of claim 2, wherein the adjustment
mechanism is selected from the group consisting of a phase change
material, a rheo magnetic fluid material, a ratcheting device a
pulley system, a heating member and electrical current member.
6. The modular prosthetic socket of claim 2, further comprising an
encircling band around the proximal brim, wherein the adjustment
mechanism comprises a tensioning mechanism coupled with the
encircling band and configured tighten or loosen to adjust tension
imparted to the struts.
7. The modular prosthetic socket of claim 6, further comprising an
additional encircling band attached to the struts, wherein the
adjustment mechanism further comprises an additional tensioning
mechanism coupled with the additional encircling band, to adjust
spacing between the struts and thus adjust an overall circumference
of the socket device.
8. The modular prosthetic socket of claim 2, further comprising a
flexible inner liner arranged on an interior aspect of the socket,
wherein the flexible inner liner enhances pressure distribution by
interfacing with the residual limb
9. The modular prosthetic socket of claim 8, wherein the adjustment
mechanism comprises a side-mounted ratcheting lanyard suspension
mechanism coupled with the flexible inner liner.
10. The modular prosthetic socket of claim 1, wherein the proximal
brim comprises: an anterior-medial proximal brim member coupled
with the proximal end of one of the struts and fabricated for an
anterior-medial aspect of the proximal brim; an ischial proximal
brim member coupled with the proximal end of another of the struts
and fabricated for an ischial aspect of the proximal brim; and two
lateral proximal brim members fabricated for the proximal ends of
another two of the struts and fabricated for two lateral aspects of
the proximal brim.
11. The modular prosthetic socket of claim 1, wherein the at least
one sensor is selected from the group consisting of an
accelerometer, an inclinometer, a gyroscope, an in-line load cell,
a pancake load cell, a rotary shaft torque sensor, and a flush
threaded pressure sensor.
12. The modular prosthetic socket of claim 1 wherein the distal
attachment member includes four connection features disposed at
spaced apart locations around its circumference, and wherein each
connection feature is configured for mounting the distal end of one
strut onto the distal attachment member, such that, when the socket
is assembled, the socket does not have a continuous surface around
the circumference of the distal attachment member.
13. The modular prosthetic socket of claim 1, wherein the struts
are moldable via application of heat to the struts.
14. The modular prosthetic socket of claim 1, further comprising a
suspension mechanism for the socket, wherein the suspension
mechanism is configured and arranged to support maintenance of the
prosthetic socket on the residual limb.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation application of U.S.
Utility patent application No. of Ser. No. 14/659,433, filed Mar.
16, 2015 which is a continuation application of U.S. Utility patent
application Ser. No. 13/675,761, filed Nov. 13, 2012, which claims
the benefit of U.S. Provisional Patent Application No. 61/559,051,
filed on Nov. 12, 2011. The disclosures of all the above-referenced
patent applications are hereby fully incorporated by reference.
TECHNICAL FIELD
[0002] The present invention relates to the field of prosthetics
and orthotics. More particularly, the present invention relates to
prosthetic sockets that are part of a prosthesis that is made to
fit the residual limb of an amputee.
BACKGROUND ART
[0003] Current prosthetic limbs for the upper and lower extremity
typically include a residual limb socket, an alignment system, and
a functional component such as a knee, foot, or hand. For any
prosthetic limb, a prosthetic socket is the portion of the
prosthesis that is designed to fit and interface the residual limb
with the rest of the prosthetic components. The socket is the
structural component of the prosthesis that contains the residual
limb, and provides connection to the other components. The
prosthetic socket is an important part of the prosthetic limb; if
it does not operate properly, utility of the distal components can
be severely compromised.
[0004] Positive and negative molds of the residual limb typically
play a central role in the making a residual limb prosthetic
socket. For example, after a professional prosthetist has fully
evaluated a patient's condition and needs, the prosthetist casts a
negative mold of the residual limb using plaster or fiberglass
casting tape. This negative mold is filled with Plaster of Paris
and allowed to harden. The negative cast is then peeled off to
reveal the newly formed positive mold. This positive mold may then
modified by the prosthetist in an attempt to create a positive form
that supports the creation of a limb socket that distributes
pressure optimally on the residual when the socket is worn. The
actual prosthetic socket is then fabricated over this positive
mold. The positive mold is broken and removed from the fabricated
socket, and the prosthetic socket may then be cut or further
modified to fit its intended location and buffed.
[0005] In addition to the aspects of fabrication process just
described, additional steps of the fabrication process may include
making and integrating flexible inner liners, locking mechanisms,
alignment mechanisms, and other components to create the final
prosthetic socket product.
[0006] When complete, the socket is typically tested on the patient
for fit and for the patient's subjective sense of how it feels. In
spite of modifications that are possible, and in spite of level of
optimization made possible by liners and locking and alignment
mechanisms, the form, as provided by the positive mold and as
reflected in the resultant socket dominate variables associated
with the fit of the socket and patient satisfaction. By this
conventional fabrication approach, the degree of possible
modification of the limb socket to optimize the fit of the residual
limb socket is actually quite limited. Accordingly, it is common
practice to make a number of "check sockets" or "diagnostic
sockets" from which the best option is chosen as the final product
for the patient.
[0007] As may be understood from the foregoing brief summary of a
conventional prosthetic fabrication process, there are aspects of
the process that are less than satisfactory, largely associated
with the centrality of physical molds within the process that
transfer size and shape information from the residual limb that is
reflected in the final prosthetic socket product. The process is
drawn out and time consuming, and inexact. And the product, when
formed and however satisfactory, is substantially fixed in form,
and not readily modifiable. The residual limb, itself, is not fixed
in form, and may vary in shape and condition with time as the
patient ages, and as the residual limb changes in response to use
and environmental conditions. Developments in the field that could
improve these shortcomings would be welcome in the medical market,
particularly in areas of the developing world where patients with
amputated limbs are medically underserved and resources are
limited.
DISCLOSURE OF INVENTION
[0008] The disclosed technology, as summarized below, relates to a
prosthetic socket for the residual limb of a person who has had an
amputation of a portion of an extremity. A prosthetic socket is a
structure that engages the residual limb, and provides a functional
base for other components, to build out a more complete a
prosthetic apparatus. Embodiments of the technology relate to the
prosthetic socket structure, to systems and kits from which a
prosthetic socket can be assembled, to larger systems or devices
that include the prosthetic socket, and to methods of making a
prosthetic socket.
[0009] Embodiments of the invention may include any one or more
particular aspects. For example, embodiments may include a modular
aspect, wherein the prosthetic socket includes, and may be
assembled from modular components. Modularity generally refers to
component parts that have features that vary in dimension or shape,
but nevertheless have attachment features in common that provide
compatibility for assembly of components into a prosthetic socket.
Modularity also generally refers aspects of assembling a prosthetic
socket, wherein modularity provides variation in dimensions or
shape from parts that are interchangeable within the specific
component types. The interchangeability aspect of modularity also
relates to repair, or reconfiguration of an assembled device,
simply by switching components in and out. Accordingly, embodiments
of the assembled sock can vary in dimensions and shape, and further
are accompanied by these capabilities of repair and
reconfiguration.
[0010] Some embodiments of the invention relate to a direct-fitting
method of selecting and manipulating component parts such that the
assembled socket substantially fits the residual limb of the person
who has had the amputation, and who will be wearing the socket.
Direct fitting is a term of art that is generally understood as
excluding the use of molds in a fitting process. Casting of
physical forms and the use of molds to replicate forms or create
complementary forms relate to the use of intervening physical forms
to transfer information about dimension and shape. Direct fitting
involves methods that transfer measurements or maps of dimension
and shape directly to the fabrication of replicate objects or
complementary objects, such as a socket that is complementary to a
residual limb.
[0011] Some embodiments of the invention may include an aspect of
fitting that relates to more than simple fitting with regard to a
static version of size and shape. Embodiments of the invention take
into consideration aspects of the movement and physical activity
that are particular to the individual, as may be habits of the
person. Some body movements may relate to types of daily activity
that the individual engages in habitually, or wishes to continue to
engage in. These considerations relate to direct fitting that is
biomechanically appropriate for the individual. By way of a simple
example, the residual limb of an athlete, a sedentary person, or an
elderly person, may all be very similar in size and shape, and yet
the biomechanics associated with these respective residual limbs
can be very different. Direct fitting, in this context and merely
by way of example, may thus include measurements of dimension and
shape of the residual limb through a range of motion, or under
conditions of bearing weight, or in situations where the body of
the individual is in varied positions. Aspects of such fitting may
further include considerations of biological structure underlying
the superficial aspects of dimension and form. By way of example,
the biomechanics of soft tissue, or injured tissue, or bone and
cartilage are different, particularly with regard to the ways in
which these tissues respond to pressure, as may be imparted by
embodiments of the prosthetic socket on the residual limb. These
various considerations in the context of direct fitting may be
referred to as dynamic fitting, or biomechanically appropriate
fitting.
[0012] Some embodiments of the invention may include adjustability
of dimensions or shape and contours of the prosthetic socket.
Adjustability is advantageous in several aspects. For example, the
residual limb is a living structure that can change in dimension or
shape over time. Such changes can occur even in short periods of
time, such as during a day, or according to the physical position
of the individual, or whether the individual is walking or
sleeping. In another time-related example, if the individual to be
wearing the prosthetic socket is still a growing child or
adolescent, the dimensions, shape, and biomechanical demands will
definitely be changing. Similarly, of course, dimensions, shape,
and biomechanical considerations change as an individual may be
physically declining with age or due to health issues.
Adjustability can accommodate such changes.
[0013] In another example, dimensions or shape or biomechanical
demands can change according to the activity of the person. Further
still, the subjective sense of what is comfortable for the person
may change, even in the absence of physical change in dimension or
form. Accordingly, capabilities and mechanisms of adjustment are
attributes of some embodiments of the prosthetic socket. Such
adjustability may include the dimensions or shape of the prosthetic
as a whole, potentially involving more than one component of the
socket. And in some embodiments, adjustability may relate more
particularly to adjustability features of particular components,
which, in turn, manifest as adjustable aspects of the prosthetic
socket as a whole.
[0014] Turning now to embodiments to summarize in further detail,
one particular embodiment relates to a modular prosthetic system
that includes a prosthetic socket for a residual limb of an
individual person, the residual limb having individual dimensions
and anatomical contours, the prosthetic socket having dimensions
and contours that substantially fit the dimensions and contours of
the residual limb, the prosthetic socket including an assembly of
components from each of three groups of socket components. These
groups of socket components include (a) one or more struts arranged
longitudinally with respect to the residual limb, each strut having
a distal end and a proximal end, (b) one or more proximal brim
members arranged proximally with respect to the one or more struts
and connected directly or indirectly thereto, and (c) one or more
distal socket members disposed at the distal base of the prosthetic
socket. One or more of these socket component groups include
modular components, the modular components having (1) variation
with respect to dimensions and/or contours and (2) common
connecting features that permit assembly of the components from the
three groups of components together to form the prosthetic
socket.
[0015] While these three particular groups of components are
recited as examples of the invention, the scope of the invention
includes other components, and any prosthetic socket component,
including any particular component or accessory element associated
with the prosthetic socket that can be modular in the sense that is
described herein. And, particularly included within the scope of
this invention is any prosthetic socket member, or component, or
associated apparatus that is described or depicted herein.
[0016] Detailed aspects of this first particular embodiment will be
elaborated on below. Following that, other embodiments will be
summarized as alternative embodiments that may also include all of
the features summarized in the context of the first embodiment.
[0017] In some embodiments of the invention, when the individual
person for whom the prosthetic socket is intended engages or
desires to engage in a range of daily activities, the dimensions
and contours of the socket may be further selected, configured, or
modified so as to be biomechanically appropriate in the context of
the daily activities of the person.
[0018] Whereas the embodiment above is summarized as having one or
more of the groups of the three groups components including
components that are modular in nature, in other embodiments, either
two of the three groups, or all of the three groups may be modular
in nature. Modular, in this context, refers to having common
attachment or connecting features despite having variation in
dimension or shape. These variable aspects with regard to dimension
or shape may be selected either on the basis of fitting the
dimension and shape of the residual limb, or on aspects of the
dimension and shape of the residual limb as the limb may assume
when in motion or generally engaging in biomechanical dynamics
associated with activities of daily living.
[0019] Some embodiments of a prosthetic socket system may include
an inventory of components for each of the groups of components
that are modular; the components that are selected for contributing
to the assembly of a finished prosthetic socket may be selected
from such inventories. As recited elsewhere, embodiments of the
prosthetic socket system may include further components or
accessory mechanisms that, like the three particular groups of
components recited, are also modular. Accordingly, such other
modular components participate in the invention by way of being
deliverable from inventories of such components. Any component
included in the assembly of a prosthetic socket, as provided
herein, is included in the scope of the invention, particularly any
component that is directly associated or interactive with any of
the three particular groups of components recited. Further
particularly included is any component or any member of a
prosthetic socket that is described or depicted herein.
[0020] Typically, the components selected from an inventory of
components for assembly into the prosthetic socket are selected by
a direct fit approach. The criteria for selecting by a direct fit
approach are to optimize the fit of the assembled prosthetic sock
with respect to the dimensions and contoured aspects of the
residual limb, and the criteria may further include optimization of
the biomechanical appropriateness of the assembled prosthetic
socket.
[0021] Inventories, as embodied by the invention, may include
collections or kits of immediately available components, or the
inventory may have on-demand nature, such that when a desired
component is not immediately available, it can nevertheless be
ordered or fabricated, as needed.
[0022] In various embodiments of the prosthetic socket system, the
modular components from any of the three groups of modular
components, as may be provided by inventories, may be any of a
prefabricated component having various attributes regarding the
nature of their from, whether its fixed or changeable. Accordingly,
prefabricated prosthetic socket components may be any of, or any
combination of standardized or substantially fixed form, a
custom-fabricated or custom-molded component, a malleable or
mechanically reformable or modifiable component, a component having
an adjustable aspect of dimension or contour, or a component having
a phase-changing composition that provides alternative dimensions,
shape, or material propertied according to phase.
[0023] Some of these recited types of prefabricated components may
be modified before being included in the assembly of a prosthetic
socket. With regard to any aspect of dimension or shape, of any of
the modular components that is modified so as to fit the dimensions
or shape of the components of the residual limb, such modification
may occur by way of a direct fit process.
[0024] As recited elsewhere, the scope of the invention as it
relates to these various fixed form vs. changeable form attributes
of components used in the assembly of a prosthetic socket include
components beyond the three particular examples of modular
components described and depicted herein. Further, while these
attributes of components are being related here in terms of their
assembly, such attributes also relate to repair and
reconfiguration. Further, while changes in dimension or shape are
being related in the context of component changes prior to assembly
of the socket, at least some of such changeable aspects of shape or
dimension that may occur after assembly of the components into the
full prosthetic socket.
[0025] In various embodiments of the prosthetic socket system, as
just referenced, various dimensions or contours of the prosthetic
socket may be adjustable. With regard to dimensions, for example,
any of length, width, circumference, or volume may be adjustable.
With regard to shape, any aspect of shape may be adjusted, such as
contours or angulations, merely by way of example.
[0026] In various embodiments of the prosthetic socket system the
adjustable dimensions or contours of the prosthetic socket may
occur by way of mechanisms or approaches that affect the dimensions
or shape of the assembled prosthetic socket as a whole. In other
embodiments, the adjustability of dimension or shape of the
prosthetic socket occurs by way of adjustment or adjustments made
particularly to any one or more of the components as selected from
the groups of modular socket components.
[0027] In various embodiments of the prosthetic socket or the
modular components thereof, adjustability can be performed either
by a person, such as a prosthetist, or such the individual person
for whom the prosthetic socket is intended. Adjustments may be made
to the prosthetic socket while the socket is being worn, or when it
is removed and more easily manipulated. In other embodiments,
adjustability may occur automatically, or with mechanical
assistance. In some embodiments, the prosthetic socket includes a
microprocessor in operable association with an adjustability
mechanism; in these embodiments the adjustable dimensions or
contours of the prosthetic socket may be operably adjustable by the
microprocessor and associated mechanism.
[0028] The prosthetic socket may be understood to provide a volume
in which the residual limb is accommodated. The volume is
encompassed within a circumferential area internal to the struts, a
distal boundary according to the distal base of the socket, and a
proximal boundary according to the proximal ends of the struts. In
some embodiments of the prosthetic socket, such volume may
adjustable, either by adjusting dimensions, shape, or a combination
thereof.
[0029] In some embodiments of the prosthetic system, a prosthetic
socket component comprises a moldable composition that may be
adjusted or reformed. In typical embodiments that are adjusted or
reformed, such changes may be made by a method comprising direct
molding of the component against at least a portion of the residual
limb. Merely by way of example, such component may be moldable by
way of heat sensitive lability or by curing, in order to stabilize
the molded form.
[0030] As referenced above, embodiments of the prosthetic socket
may be sized, shaped, or adjusted so as to be biomechanically
appropriate both for the residual limb, itself, but more generally
for the activities of the person, or for particular aspects of
anatomy and tissue that underlie the superficial aspects of
residual limb dimension or shape. In some embodiments of the
prosthetic socket, biomechanical considerations particularly
concern the distribution of pressure against the residual limb in a
controlled manner when the prosthetic socket is being worn by the
individual
[0031] Accordingly, in some embodiments the pressure from the
prosthetic socket on the limb may be distributed with substantial
evenness across an interfacing region between the prosthetic socket
and a portion of the residual limb, when the residual limb is
disposed within the socket. In other embodiments, the pressure from
the prosthetic socket on the limb may be distributed preferentially
toward one or more particular locales within an interfacing region
between the prosthetic socket and a portion of the residual limb,
when the residual limb is disposed within the socket. In any of
these embodiments that relate to distribution of pressure by the
socket against the residual limb in a controlled and
biomechanically appropriate manner, a pressure distribution profile
may advantageously take into account the range of activities of
daily living.
[0032] Some embodiments of the prosthetic socket further include a
flexible liner arranged to be internal to arranged to line an
interior aspect of the socket, such interior aspect including
interior aspects of any of the prosthetic sockets structural weight
bearing components, as for example proximal brim member, the
struts, or the distal members. When the prosthetic socket is worn
by the person, the liner thus represents a surface across which
pressure is mutually transferred between the prosthetic socket and
the residual limb. In a typical instance and in the absence of an
intervening liner, the structural weight bearing components provide
the initial locus of pressure impinging on the residual limb from
the prosthetic socket. In some embodiments, the flexible liner
possesses sufficient stiffness and resilience that it can support
distribution of at least some pressure across its surface, away
from the struts or other structural weight bearing components. In
some of these embodiments, the flexible liner has sufficient
stiffness and resilience that it can support distribution of
pressure with substantial uniformity across its surface.
[0033] Some embodiments of the prosthetic socket include an
external weight bearing surface, the external surface comprising
external aspects of any of the proximal brim member, the struts, or
the distal member. In particular embodiments, the external
weight-bearing surface has sufficient stiffness and resilience that
it can support distribution of at least some pressure across its
surface, away from the structural weight bearing components. In
some of these embodiments, the external weight-bearing surface has
sufficient stiffness and resilience that it can support
distribution of pressure with substantial uniformity across its
surface.
[0034] In some embodiments of the prosthetic socket, the one or
more distal socket members disposed at the distal base of the
prosthetic socket include a socket cup disposed within the distal
base, the socket cup configured to support a distal end of the
residual limb. As with other distal members or elements of the
prosthetic socket, the distal cup may be modular in every sense of
modularity recited elsewhere.
[0035] With regard to embodiments of prosthetic socket and its
applicability and positioning on a residual limb when the socket is
being worn by the individual person, a distal end of the amputated
limb is supported by a distal socket member, a distal portion of
the residual limb is supported by or within the one or more struts,
and the portion of the residual limb proximal to the portion
embraced or supported by the struts is supportably enclasped by the
proximal brim.
[0036] Embodiments of the prosthetic socket are adaptable to a
residual post-amputation portion of any of both an upper extremity
or a lower extremity. With regard to an upper extremity, a residual
post-amputation portion of the upper extremity may be at an
above-elbow arm (trans humeral) site or a below-elbow
(trans-radial) arm site. With regard to a lower extremity, a
residual post-amputation portion of the lower extremity may be at
an above-knee (trans-femoral) leg site or a below-knee
(trans-tibial) leg site. Basically, embodiments of the prosthetic
device may be adaptable to any conventional site of amputation, at
any level. Further, embodiments of the prosthetic device may be
adaptable for use as any of an immediate post-operative socket, a
diagnostic socket, a temporary socket, or a definitive socket.
[0037] In various embodiments of the prosthetic socket, components
from any of the three recited groups of socket components (distal
members, struts, proximal brim members), and any other component of
the prosthetic socket may include a shock-absorbing material. By
way of example, one particular material is low durometer
silicone.
[0038] A common problem for prosthetic sockets, in general, relates
to the accumulation of moisture that originates from the surface of
the residual limb. Such moisture can be irritating or uncomfortable
to the wearer of the socket, or worse, it can contribute to sores,
and it may generally compromise functionality of the prosthetic
system. Accordingly, some embodiments of the prosthetic socket may
include a moisture management or evacuation system. Aspects of a
moisture evacuation system may be included in any portion or any
component of the prosthetic socket, including, in particular
components from any of the three recited groups of components
(distal member, struts, proximal brim members).
[0039] Examples of moisture evacuation systems included in the
scope of the invention include any one or more of a roll-on gel
liner with integrated vertical moisture wicking channels, proximal
internal and external seals, moisture expulsion valves, and a
locking mechanism with an integrated moisture evacuation route.
[0040] As recited above, embodiments of the prosthetic socket may
have a single strut, however other embodiments include a plurality
of struts such as two or three, or more. Some particular
embodiments include four struts. Struts, if plural, are typically
arranged circumferentially around a central space that the residual
limb occupies when the individual is wearing the prosthetic socket.
Embodiments of the invention include any practical or
biomechanically advantageous spatial arrangement of the struts. In
some embodiments, the struts are evenly spaced apart. In some
embodiments, the struts are arranged in a symmetrical manner, and
in some embodiments, struts are arranged in an overlapping
manner.
[0041] The distal ends of the struts are typically arranged to
support distal members of elements of the prosthetic socket. In
some embodiments, the struts are mutually convergent at their
distal ends, and joined to form a distal base of the prosthetic
socket. In other embodiments, the struts do not converge
themselves, but they support a distal base including one or
elements, such as a distal cup.
[0042] The surfaces of strut embodiments can interface directly
with the residual limb, although in some embodiments flexible
liners may be disposed within internal aspect of the socket,
thereby intervening between the struts and the residual limb. By
any arrangement, however, it is advantageous for the struts to
present tissue-friendly, non-irritating or non-injurious, or
biomechanically appropriate surface that will abut residual limb
tissue when the socket is being worn. According, and merely by way
of example, struts may include any one or more of an oval-shaped
cross section, rounded edges, or a surface that is convex with
respect to the residual limb surface.
[0043] In some embodiments of the prosthetic socket system, any one
or more the modular prosthetic socket components may include
features that provide adjustability to dimensions or shape, such
as, merely by way of example, in any of length, height, width,
curvature, contoured aspects, conformability, flexibility,
rigidity, durometer, elastic modulus, positional orientation, and
angulation.
[0044] In some embodiments, adjustability is provided by a
mechanical apparatus or arrangement of interacting elements. One
particular mechanical arrangement may include a telescoping
mechanism that can affect strut length or width. In some
embodiments, adjustability mechanisms may include gearing features,
cam elements, or moveable wedges.
[0045] Some embodiments of the prosthetic system may include one or
more encircling bands around the struts or around the brim members,
as summarized further elsewhere. These encircling bands can provide
a relatively static support roll, in which they stabilize or secure
the struts or any structural component, contributing to the overall
structural integrity of the prosthetic socket, or they provide a
more active adjustable role. Adjustments provided by an encircling
band may include adjustments to the circumference of the socket, or
more particularly to the circumference described by the struts.
Alternatively, inasmuch as the encircling bands can be elastic or
tensionable, the encircling bands can adjust tension imparted to
the struts even in the absence of noticeable change in
circumference.
[0046] In various embodiments of the prosthetic socket, one or more
of the adjustable aspects of any structural component may manually
operable, such operability available either to the person wearing
the prosthetic socket or to a prosthetist working with the person.
Adjustments may be made either when the prosthetic socket is being
worn, or when it is not being worn by the person.
[0047] In other embodiments of the prosthetic socket, one or more
of the adjustable aspects of any structural component may be
automatically operable. Automatic, in this context, refers to the
participation or facilitation of adjustment by any non-manual
approach, including adjustments facilitated by microprocessors, or
by material properties that confer adjustability. Accordingly, some
strut embodiments are operably adjustable by a microprocessor and
an associated adjustment mechanism.
[0048] In other embodiments, a strut may be adjustable by changes
that occur in phase change materials incorporated in the strut.
Merely by way of example, phase change properties may elate to any
one or more of durometer, rigidity or elasticity, electrically
catalysable changes, light activatable changes,
chemically-catalysable changes, or temperature-related changes.
[0049] As noted above, some embodiments of a prosthetic socket may
include one or more encircling bands arranged around and connected
to any prosthetic socket component, as for example, the struts or
proximal brim members. In some embodiments, an encircling band is
arranged and adapted so as to apply pressure radially inward on the
struts. In some embodiments, the circumference or tension of an
encircling band is adjustable. In various of these embodiments, an
adjustment of the circumference or tension of the encircling band
is operable to adjust a shape or contour of the prosthetic
socket.
[0050] Some embodiments of the prosthetic socket the socket include
two or more encircling bands arranged around and connected to the
longitudinal struts, and the socket includes at least one
tensioning band connecting the at least two encircling bands, as
for example, in an interlaced manner. In such embodiments, the two
or more bands may be arranged in a longitudinally spaced apart
relationship, and the interlaced tension bands may be arranged to
stabilize that spaced apart relationship. Further, in some
embodiments that include tensioning bands associated with either
the struts or the encircling bands, tension bands are adjustable
such that the tension they provide is adjustable.
[0051] Some embodiments of the modular prosthetic system, in
addition to the prosthetic socket as extensively described herein,
may further include a distal operable prosthetic element connected
to the distal base of the prosthetic socket. Such operable
prosthetic element may be of any type known in the art, such as
wherein any of a prosthetic elbow, a prosthetic hand, a prosthetic
knee, or a prosthetic foot.
[0052] Some embodiments of the modular prosthetic system, in
addition to the prosthetic socket itself, may further include a
suspension mechanism or rigging for the socket that is configured
and arranged to support maintenance of the prosthetic device on the
residual limb. Embodiments of the suspension system may be
generally of any conventional type known in the art. The suspension
systems may also be understood as modular in nature, in that in
spite of variations in form or structure, they include attachment
features that have substantial commonality or sufficiently
flexibility that they can be operably attached to the prosthetic
socket.
[0053] In some prosthetic system embodiments that particularly
include a suspension rigging or mechanism, the system includes an
inventory of such mechanisms or riggings, from which an embodiment
appropriate for the individual may be selected. As with other
modular aspects of the prosthetic system, modular suspension
mechanism variations can include variations in dimensions and
aspects of shape or configuration, but include attachment features
in common that attach to compatible attachment features of the
prosthetic socket. The suspension mechanism variations in the
inventory may be selected for structural features that fit the
person and are biomechanically appropriate for activities or
desired activities of the person.
[0054] Embodiments of the prosthetic socket may further include
other components or members, such as, and merely by way of
examples, an ischial weight-wearing member, a tendon-wearing
member, a supercondular extension member, a support or control
extension member, a proximal brim member adapted for ischial
weight-wearing, or a proximal brim member that is specially
designed for patellar tendon weight-bearing. Any of the members may
have modular aspects, and may be drawn from an inventory of such
components, as has been described in the context of other modular
components provided herein.
[0055] Some embodiments of the prosthetic system, the prosthetic
sock, or any particular component thereof may include sensors.
Typically, such sensors are in an operable relationship with either
a microprocessor and/or responsive mechanical elements. Such
sensors may include, merely by way of example, an accelerometer, an
inclinometer, or a gyroscope. These sensors and associated smart,
operable, or responsive components may be understood to provide
adjustability to the prosthetic socket. In some embodiments, the
microprocessor is in communication with one or more additional and
separately located sensor or microprocessor, said additional and
separately located sensor or microprocessor may be disposed in any
appropriate location within the prosthetic socket, or at another
location within a larger prosthetic device that also includes the
prosthetic socket.
[0056] As with adjustability as described elsewhere herein,
adjustability is generally directed toward optimizing aspects of
fit and flexibility, and aspects of biomechanical appropriateness
for the individual. These forms of adjustment would generally be
considered automatic by virtue of microprocessors and responsive
mechanisms, but they may also include manually operable
options.
[0057] In addition to the first embodiment of a modular prosthetic
system, as referenced above and then extensively detailed, the
invention includes other particular embodiments. In the first
embodiment, the prosthetic socket is one in which at least one of
the three recited groups of components (struts, proximal brim
members, and distal socket members) include components that are
modular in nature. In the first embodiment, the prosthetic socket
had dimensions and contours that substantially fit the dimensions
and contours of the residual limb.
[0058] In a first alternative embodiment of a modular prosthetic
system, all of the three recited groups of components are modular.
And the this first alternative embodiment, the prosthetic socket,
in addition to the prosthetic socket fitting the dimensions and
contours of the residual limb, the prosthetic socket is further
configured to biomechanically appropriate for a range of activities
in which the individual engages in, or in which the individual
desires to engage, or desires to continue to engage in.
[0059] In a second alternative embodiment of a modular prosthetic
system, with reference to the three recited groups of components,
all of the three recited groups of components are modular, and at
least one of those three groups of modular components includes
components that are adjustable with respect to component dimensions
of contours.
[0060] In a third alternative embodiment of a modular prosthetic
system, with regard to the three recited groups of components, all
three of the recited groups of components are modular, and the
system further includes an inventory of modular components for each
of the three groups of modular socket components. Modular
components from each of the groups selectable for assembly into a
complete prosthetic socket.
[0061] A fourth alternative embodiment of the invention provides a
kit of components from which a modular socket may be assembled. All
of the recited groups of socket components are modular, and the
components from the groups of socket components included in the kit
are selected so as to be assemblable into a prosthetic socket that
substantially fits the dimensions and contours of the residual limb
and is biomechanically appropriate for activities of the
individual.
[0062] Embodiments of the invention also include methods of making
or assembling a prosthetic socket for a residual limb of an
individual person who has experienced the amputation of an
extremity. Accordingly, one particular method embodiment is
directed to making a modular prosthetic socket fitted to a residual
limb of an individual person, the residual limb having individual
dimensions and anatomical contours.
[0063] This method embodiment includes providing inventories of one
or more groups of modular prosthetic socket components from which
to assemble the prosthetic socket, the components within each group
having (1) variation in dimension or contour and (2) common
connecting features that permit assembly of the individual
components together to form the prosthetic socket. This method
embodiment further includes, with reference to the inventory of
each component group, selecting one or more components therefrom to
assemble a residual limb socket that will substantially fit the
individual dimensions and contours of the residual limb when said
components are later assembled into a residual socket. And the
method further includes assembling the selected prosthetic socket
components from each of the groups of components to form the
prosthetic socket for the residual limb.
[0064] In this method embodiment, the groups of prosthetic
components for which inventories are provided include (a) struts to
be arranged longitudinally with respect to the residual limb, each
strut having a distal end and a proximal end, (b) proximal brim
members to be arranged proximally with respect to the one or more
struts and connected directly or indirectly thereto, and (c) distal
socket members to be disposed at the distal base of the prosthetic
socket. In method embodiments wherein the three groups of
prosthetic group components are modular in nature, the method may
further include selecting components from all three groups and
assembling them together to form the socket.
[0065] While these three particular groups of components are
recited as examples that are involved in the method, the scope of
the method includes the use of other components, and any prosthetic
socket component, including any particular component or accessory
element associated with the prosthetic socket that can be modular
in the sense that is described herein. And, particularly included
within the scope for use in the method is any prosthetic socket
member, or component, or associated apparatus that is described or
depicted herein.
[0066] In some embodiments of the method, selecting a prosthetic
socket component is based on determining aspects of dimension
and/or contours of the distal portion of the residual limb, said
determining step including any one or more of scanning,
photographing, casting, or mapping with a three-dimensional point
reference device a three-dimensional digital or physical
representation of the residual limb.
[0067] In some embodiments of the method, selecting individual
prosthetic device components includes directly fitting the
components to achieve the dimensions and anatomical contours of the
assembled socket. In some embodiments of the method, selecting
individual prosthetic device components may includes directly
fitting the components to achieve a fit that is biomechanically
appropriate for activities of the person. A fit that is
biomechanically appropriate may include taking into consideration
the height and weight of the person, and it may include taking into
consideration distribution of pressure by the prosthetic socket on
the residual limb.
[0068] In some embodiments of the method, a component selected from
an inventory of group components includes a composition that is
moldable; in this case, method may further include molding the
component directly against at least a portion of the residual limb.
Such molding is typically performed in order to improve the fit of
the prosthetic socket with regard to the dimensions or contours of
the residual limb.
[0069] In some of the component embodiments, the moldable
composition is labile to heat at a temperature that is sufficiently
low so as to not injure a residual limb when the limb is protected
by a thermal barrier. In this case, the method may further include
heating the moldable component, thermally protecting the residual
limb with a flexible thermal barrier, and molding at least a
portion of the component against the portion of the residual limb.
In some of the component embodiments, the moldable composition is a
curable composition. In this case, the method may further include
molding the component against at least a portion of the residual
limb, and then curing the component in its molded form.
[0070] In some embodiments of the method, prior to the assembling
step, the method includes providing an inventory of encircling
members that are configured to be arranged orthogonal to the struts
and connected thereto, and then including the encircling members in
the assembling step.
[0071] Some embodiments of the method further include adjusting any
of the dimensions or contours of the prosthetic socket. In some of
these embodiments, adjusting any of the dimensions or contours of
the prosthetic socket includes improving the fit of the socket to
the residual limb. In some embodiments of the method, adjusting any
of the dimensions or contours of the prosthetic socket may further
include improving a biomechanically appropriateness of the
dimensions or contours for activities of the individual.
[0072] In some embodiments of the method, the adjusting step is
performed by a professional prosthetic fitting expert. In some
embodiments, the adjusting step may be performed by the person
wearing the socket. In some embodiments, the adjusting step is
performed automatically by a microprocessor-associated
mechanism.
[0073] In some embodiments of the method, adjusting any of the
shape or dimensions of the residual limb socket frame may include
adjusting a volume encompassed within a circumferential boundary
defined by the struts, a distal boundary according to the distal
cup, and a proximal boundary according to the proximal ends of the
struts.
[0074] In some embodiments of the method, adjusting may include
redistributing pressure exerted by the prosthetic socket on regions
of the residual limb, such redistribution referring to when the
person is wearing the prosthetic socket.
BRIEF DESCRIPTION OF THE DRAWINGS
[0075] FIG. 1 is a perspective view of an example of a right
above-knee (trans-femoral) prosthetic socket after the modular
members have been selected, assembled, formed, and adjusted to fit
over an individual's residual limb.
[0076] FIG. 2 is a perspective view of an example of a right
above-knee (trans-femoral) prosthetic socket after the modular
members have been selected, assembled, molded, but before it has
been directly molded and adjusted to fit over an individual's
residual limb.
[0077] FIG. 3 is a frontal cross sectional view of an exploded
right above-knee (trans-femoral) prosthetic socket.
[0078] FIG. 4 is a frontal cross sectional view of the above-knee
(trans-femoral) prosthetic socket shown exploded in FIG. 3 after it
has been assembled and including a total surface-bearing flexible
inner liner after it has been assembled and formed to the
individual's residual limb.
[0079] FIG. 5 is a top view of an example of a right above-knee
(trans-femoral) prosthetic socket after the modular members have
been selected, assembled, molded, but before it has been adjusted
to fit over an individual's residual limb. This perspective gives a
clear view of an encircling tensioning member without
microprocessor control.
[0080] FIG. 6 is a perspective view of an example of a below-knee
(trans-tibial) prosthetic socket.
[0081] FIG. 7 is a perspective view of an example of an above-elbow
(trans-humeral) prosthetic.
[0082] FIG. 8 is a perspective view of the same prosthetic sock as
seen in FIG. 7, after the after the proximal brim member 83 of FIG.
7 has been molded and trimmed to produce the formed and trimmed
proximal brim member 83 of FIG. 8 in order to allow for increased
range of motion.
[0083] FIG. 9 is a perspective view of an example of an above-knee
(trans-femoral) modular prosthetic socket after it has been formed
to an individual's residual limb, this particular example having a
cut-out in the strut member that allows for an encircling band to
sit flush.
[0084] FIG. 10 is a perspective view of an example of an above-knee
(trans-femoral) modular prosthetic socket after it has been formed
to an individual's residual limb.
[0085] FIG. 11 is a perspective view of an example of a prosthetic
socket of the present invention.
[0086] FIG. 12 is a perspective drawing of an example of a
prosthetic socket of the present invention. This drawing is an
example of a below-elbow socket, otherwise known as transradial
prosthetic socket.
[0087] FIG. 13 is a superior view of the distal cup of the Symes
(an ankle disarticulation socket) modular prosthetic socket as also
seen in side view in FIG. 14.
[0088] FIG. 14 is a side view of a prosthetic Symes socket (ankle
disarticulation socket), showing, in particular, a height
adjustable member with option for angular change.
[0089] FIG. 15 is a perspective view of an above-knee
(trans-femoral) socket that shows detail of a proximal brim with an
adjustable section, as well as an ischial seat extension.
[0090] FIG. 16 is a perspective view of the distal portion of an
above-knee (trans-femoral) prosthetic socket, showing detail
related to an integrated suspension mechanism, and modular
alignment feature and a settable hinge.
[0091] FIG. 17 shows lateral cross-section views of modular
adjustable joint and hinge options, showing an option of utilizing
wedges that may be removed or replaced to change the desired
angle.
[0092] FIG. 18 shows a hinge with setscrew, hinge cover, and strut
wedge.
[0093] FIG. 19 is a superior perspective view of modular adjustable
joint ratchet options that may be utilized for the prosthetic
socket.
[0094] FIG. 20 shows an adjustable hinge with the additional
features of retainer members as well as having the entire set beam
member being a separate member that may be placed separately and
set into place.
[0095] FIG. 21 is a perspective view of an example of prosthetic
socket having an adjustable hinge member with microprocessor
control.
[0096] FIG. 22 is a perspective view of an example of a portion of
a prosthetic socket having an adjustable member with microprocessor
control.
[0097] FIG. 23 is a perspective view of an example of a prosthetic
socket having oval shaped struts 270 that extend past the socket
and form a congruent pylon and foot system, representing an entire
prosthesis.
[0098] FIG. 24 is the same illustration as FIG. 23, except that it
shows the option of having additional adjustment capabilities
incorporated into the struts 278 and the interface members 272,
276, and 288.
[0099] FIG. 25 depicts an embodiment similar to that in FIG. 23,
except that it demonstrates with an outline that there is the
option of having the entire modular prosthesis covered with a
cosmetic covering or fairing 288.
[0100] FIG. 26 is a perspective view of a prefabricated wrap-around
cosmetic cover 290.
[0101] FIG. 27 is a perspective view of oval shaped struts 294 and
300, Y connecting joint member 298, proximal brim member 292, and
proximal brim connector 296.
[0102] FIG. 28 is a perspective drawing of an oval shaped strut
member.
[0103] FIG. 29 is a perspective drawing of an oval shaped strut
member 304 with contour and transverse plane rotation 304.
[0104] FIG. 30 is a lateral perspective of an oval shaped strut
member 304 with contour and with adjustable interface member
310.
[0105] FIG. 31 is a flow chart showing an example of the steps
involved in providing a prosthetic limb for an individual by the
method for fitting a custom modular prosthetic socket according to
the present invention.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
Overview
[0106] The applicability of molds to the process of creating
sockets that accommodate residual limbs and to provide a proximal
base for effective prosthetic limbs and operable distal effectors
is pervasive in the prior art, and has also been broadly helpful
and therapeutically beneficial. As presented in the background,
however, there are inherent and practical limitations to this
approach. Such limitations relate to resources, such as time and
cost, and to actualities of fit to a residual limb, wherein fit
relates to a limb portion that is actually not well suited for
bearing weight, providing a base of prosthetic limb operability. A
residual limb comes with complications related to body heat and
moisture that effect the interaction of the residual limb and the
socket. And, the residual limb, itself, is dynamic in shape and
internal structural details over time. These changes occur both in
the short term, as during the course of a day, and in the long
term, as the individual ages and deals with changes in body
structure and activities of daily living.
[0107] A number of innovations disclosed herein address these
briefly described complicating aspects of providing a residual limb
prosthetic socket to that fits well, as a baseline, but is further
dynamic in aspects of its fit, and adjustable in aspects of its
fit. As may be understood by this disclosure, these aspects of fit,
dynamicity of fit, and adjustability of fit, at least in part,
relate to the direct-fit manner in which embodiments of the
invention are made.
[0108] Embodiments of a method for making a prosthetic socket, as
described herein, may use a plurality of premade or custom-made
members that are designed to function in a compatible way with one
another, and are individually selected and assembled in a
customized and specific manner to form a modular prosthetic socket
to meet the needs of any amputee, whether for an upper or lower
extremity.
[0109] Embodiments of residual limb sockets described herein may
include a distal base member with specialized and contoured
pressure distribution struts. In one embodiment, by way of example,
two flexible and adjustable members are positioned within each of
the vertical and rigid strut sections (vertical strut sections
comprise the two flexible sections and two rigid and specially
contoured strut members made of carbon fiber and/or acrylic resin).
An adjustable proximal brim with a ratcheting patient-operated
control may be used. The specialized contours of the present
prosthetic socket are configured to block rotation, and to provide
control and stability inside the socket with comfort and without
the need for total contact. This arrangement provides the advantage
of greater heat dissipation and a non-circumferential design that
allows greater adjustability. Other embodiments, however, may
include a liner that provides total contact between the socket
surfaces and the residual limb.
[0110] The present invention allows for various types of sockets
and various options for pressure profile distribution, as well as
the modular and adjustable ability to change as the patient
changes.
[0111] Embodiments of the basic method for making a prosthetic
socket described herein include a modular approach that uses a
plurality of pre-fabricated or custom-made members that are
individually selected, oriented, and assembled in a customized and
specific manner to meet the needs of the amputee. The result of
this modular prosthetic socket method is a custom modular member
prosthetic socket. The custom modular member prosthetic socket
allows for one trained in the field to fit the prosthetic socket
directly to the amputee's residual limb for an amputee of either
the upper or lower extremity, without the need to make a negative
mold or a positive mold. The custom prosthetic socket can achieve
optimal functioning results and comfortable fit by applying
pressure in pressure tolerant areas of the residual limb, while
simultaneously relieving pressure in pressure sensitive areas of
the residual limb. A total surface-bearing interface may augment
the modular support frame of the custom modular member prosthetic
socket for those who require a circumferential or total
surface-bearing prosthetic socket. Once fit to the amputee's
residual limb, the modular system can serve as a complete,
independent, and fully functioning prosthetic socket with its own
interface options. Alternatively, it can be made to work with other
related devices, including gel liners, suction systems, pin
systems, vacuum systems, adjustable systems, and modular alignment
systems.
[0112] Each member for the modular method is designed for
compatible assembly. The modular method may include adjustability
or conformability within one or more of its members. This
adjustability may come in the form of being able to be trimmed to
the proper size, heat molded, formed to shape, and then set. The
adjustability includes telescoping height adjustability, hydraulic
controlled adjustability, pneumatic controlled adjustability,
hinged controlled adjustability, slide controlled adjustability,
foldable adjustability, and ratcheting adjustability. The members
of the socket are thus expandable, or otherwise mobile,
conformable, changeable, or adjustable. By selecting individual
members and adjustability of individual members, then orienting and
assembling selected members to match the needs and conditions of
the amputee, the modular methods and resulting products described
herein offer the advantages of a custom made prosthetic socket with
design modularity, while at the same time avoiding time consuming
and wasteful mold making techniques as well as the disadvantages
and limitations of premade sockets and alternative approaches of
the prior art.
Embodiments and Features
[0113] The specific members, orientation, adjustability, materials,
shape, contour, and relationship of embodiments of the modular
prosthetic socket described herein are diverse in some aspects of
their form, but nevertheless have features in common, particularly
connection features as befitting of a modular overall design.
Modularity is purposefully directed toward providing versatility
and adaptability. The design is such that each member can be
selected for its material composition, strength, durability, cost,
shape, and size to match the needs of a particular amputee.
Further, the relationship between and among members, including
their adjustability properties, locking abilities, control method,
fastening method, and orientation, may also be selected to match
the needs of the patient. A pre-fabricated hinge and/or control
mechanism may be selected if an adjustable and locking relationship
is desired. Since the size, shape, and needs of all residual limbs
are unique to each specific individual, each produced embodiment or
rendering of the methods of making and using embodiments may be any
of individualized, or custom-made, custom-assembled, or
custom-adjusted. For the sake of describing the invention in
detail, as a general module, as templates, as standard sizes or
forms, as an inventory, as a kit, and as particular embodiments are
described. In general, the modular prosthetic socket method
described may include one or more of the following types of
pre-fabricated or custom-made members: a distal control and
attachment member, one or more adjustable members, one or more
structural struts or longitudinal links, height or length
adjustable or extendable members, and/or width adjustable or
extendable members, proximal brim and/or connecting link members,
and additional members.
[0114] The modular members, per embodiments of the invention, may
be made in a series of sizes and shapes of premade members that may
be selected to fit a substantial portion of the residual limbs
extant within the population people with amputations. For cases
where the shape, contour, or size of the amputee does not work well
with premade members, custom molded members may be fabricated
independently of or in conjunction with members that may be
provided in a range of standardized sizes or form, as for example,
could be included in an inventory of parts. The custom molded
members may be made with pre-made members that are made with a
moldable material, or they may be made with one of the techniques
that are already available in commerce.
[0115] Embodiments of the invention also are adjustable, such
adjustability provided, at least in part, by a modular approach to
assembly. Adjustability and modularity lend themselves particularly
well to trial fittings and trial periods of use, in order to arrive
a final version of a residual limb socket and related prosthetic
components. Trial fittings and trial periods of use also may be
appropriate as needs of the patient change, or as the physical from
of the residual limb changes over time.
[0116] The distal member of the modular socket design, as provided
herein includes attachment and adjustability mechanisms that are
appropriate and compatible with modular alignment and component
connecting members. This connection mechanism of the distal member
serves as a connector between the custom member modular socket and
an adjustable or non-adjustable pylon, modular alignment system, or
other component connection like a knee, foot, or hand. The
connection member is designed for ease of use and compatibility
with previously established modular alignment devices, as well as a
wide array of alignment options to work properly with the different
alignment needs of different individuals.
[0117] Typical applications for embodiments of the modular method
and device product include any of a definitive prosthetic socket, a
temporary prosthetic socket, an initial prosthetic socket, a
post-operative prosthetic socket, and a diagnostic prosthetic
socket.
Customizability by Way of a Modular Assembly
[0118] Embodiments of the invention provide a modular prosthetic
socket method and resultant product where pre-fabricated or custom
made modular members are selected and linked together to fit the
needs, shape, and size of any amputee's residual limb, for either
the upper and lower extremity. The modular and adjustable
prosthetic system or parts therein may be used as any of a
definitive prosthetic socket, temporary prosthetic socket, initial
prosthetic socket, post-operative prosthetic socket, diagnostic
prosthetic socket, and/or as a casting aid for a prosthetic socket.
The modular method and resultant product comprises prefabricated or
custom members, and may include any of the following: distal
control and attachment member, one or more adjustable members, one
or more structural struts or longitudinal links, height or length
adjustable or extendable members and/or width adjustable or
extendable members, proximal brim and/or connecting link members,
and additional members.
[0119] A variation in the fitting process of the modular design may
include having a plurality of members that are preassembled for
standard sizes, but allow for customized adjustment or swapping out
of members to individually fit a given amputee. Hence, standard or
typical limb sizes and shapes may be pre-assembled or partially
pre-assembled, and then simply custom adjusted or modified to match
the individual. An advantage of this approach is that less time is
required to fit standard or common residual limb sizes and shapes.
This alternative fitting method still provides the advantages of
the modularity in design, in that it offers such benefits as
augmentation and adjustability.
[0120] The embodiments of the methods, resulting products, and
designs described herein may be applied to other applications that
are related to prosthetic devices, such as orthotics, robotics,
crutches, exoskeletal applications, wheelchairs, mobility
equipment, and other applications.
Embodiments and Features of a Distal Cup
[0121] The distal control and attachment member embodiments may be
a custom made or a pre-fabricated contoured distal "cup". The
distal cup may vary for different amputation levels and sizes of
the residual limb, and may be a fixed form or moldable or
adjustable by heat modification or other method to reshape or
accommodate for any high-pressure areas, sensitive areas, or
otherwise specific areas. This process of adjustability may vary or
differ per application. It may include use of materials such as
heat relievable thermoset plastics and thermoplastics. The distal
cup may also be made of a moldable material such as carbon or
fiberglass braid with water-catalyzed resin, UV catalyzed resin, or
other suitable material. Designs may vary, depending on the
specific application, circumstance, and location of application.
The variability of options for materials, sizes, and methods is
designed to meet the size, amputation level, and functional needs
of any amputee.
[0122] This distal section serves as an attachment segment where
various types of components and additions may attach both
proximally and distally. For example, there may be a compatible
four hole attachment pattern and center bolt acceptor that can work
with various and standard manufactured knees, feet, and other
terminal devices. The distal cup may also have an integrated distal
end pad that is either custom made or off-the-shelf, and/or
suspension components such as a lanyard suspension system, suction
suspension system, pull-bag suspension system, pull n' tie
suspension system, or other suitable system. The distal cup also
serves to control the distal aspect of the amputated bone. This is
a key aspect to the design, in that an amputee must have adequate
control of the prosthesis for successful use thereof. Moreover,
distal control is critical to biomechanical control and stability.
The distal cup is designed to serve in providing this control by
having multiple contoured shapes that can work to provide
anatomical control for the various levels of amputation. For
example, trans-femoral amputees commonly get excess pressure and
resultant pain at the distal lateral and distal posterior-lateral
aspect of the prosthesis due to the biomechanical forces in that
area during gait. Therefore, the distal cup for trans-femoral
amputees is designed to have a contoured relief and more proximal
control crossbar options that will help to avoid these common
problems. Another key aspect to the design is that the distal cup
is made to allow for attachment of the control struts at the
appropriate location, angle, and height to allow for maximized
control of boney anatomy and accommodation of soft tissue.
[0123] For a push-on suction socket variation, various sizes of
pre-made distal suction cups made out of silicone, urethane, or
other appropriate material can be fit to the patient, or if the
patient does not fit well in the off-the-shelf sizes, a custom
silicone distal suction cup may be fabricated. The selected
material for the distal silicone cups may include design details
such as softer durometer distal portions to improve comfort as well
as adapting the contour to match the patient, and outside material
distally to improve the ability to adhere to the distal base
member. This silicone cup may have integrated locking/securing
members that may then be locked into and adhered to the distal base
of the modular cup. For example, Velcro type tabs can be integrated
into the distal silicone cup, which can lock into the socket, or
set screws, can be used as well as undercut tabs that allow the
silicone cup to lock into place in the socket. To ensure an optimal
fit between the silicone distal suction cup and the distal base
member, silicone adhesive, silicone replicator, or other material
may be used to adhere the silicone distal suction cup to the distal
base member while at the same time filling in any voids or lack of
total-contact. From the distal base with integrated distal suction
cup, any of the modular member options may be selected as usual to
match the patient's needs. This push-on suction socket style is
especially applicable to disarticulation level amputees.
Embodiments and Features that Provide Adjustability
[0124] Embodiments of a prosthetic socket as provided herein may
include one or more adjustable member, mechanical joints, hinges,
flexible sections, durometer changeable sections, replaceable fixed
angle sections, microprocessor controlled joints, and/or other
suitable adjustable sections that may be dynamically or statically
adjusted to fit the patient and meet his or her needs. This
adjustable section is one way that the present invention allows for
volume adjustability or changes to the amputee's residual limb. As
presented, the mechanism of adjustability may vary. There may be a
specialized hinge or adjustable section that may be automatically
or manually adjusted to meet the amputee's needs. If automatically
adjusted, the system may include the use of pressure sensors and a
microprocessor or microprocessors that control adjustment of the
socket automatically to avoid excess pressures. The mechanism of
automated adjustment may be a geared mechanism, ladder ratcheting
system, automated set pin, hydraulic control, pneumatic control, or
other suitable system. A mechanically adjustable section may also
be utilized where a manual set screw, button lock, bail lock, drop
lock, ratchet lock, or other suitable manual set option may be
utilized to set the angle of the adjustment or range of
adjustments. The mechanical adjustable member may be manufactured
as a specialty hinge, for example, that can easily be riveted to
the distal control member and strut members, and may include a
mechanism that allows for user or practitioner adjustability. The
adjustable members can also be made to allow for installation into
a lamination, and can also be made to affix and function with
various socket materials.
[0125] A durometer or rigidity changeable sections may be utilized
as an adjustable section member that has the ability to
automatically or manually change in durometer at the desired time.
For example, if the patient wants to adjust the fit of their
prosthetic socket, he or she can pass a small electrical charge
through their adjustable member section by pressing a button that
then allows the specialized material to be flexible until at the
adjusted position. Then it may be changed back to a stiff or set
material. The adjustable member may also be a low profile and light
option of a rigid plate that is selected for the correct angle, and
may be wedged or changed out for a different angle for adjustment.
If the weight or activity level of the amputee is such that the
adjustable component requires reinforcement, such reinforcement may
be added after the desired angle has been established by a riveted
reinforcement beam, fiberglass tape, or other suitable way to
increase the strength capabilities of the adjustable section. The
manual or automated system may include or be integrated into the
strut and distal cup design described above. For example, if a
ladder and automated ratchet is utilized, the ladder aspect of the
strut may be designed to slot into the shaft or long axis of the
strut for which it controls. The advantage of such an integrated
design is to protect components and reduce bulkiness of the overall
design. The proximal brim design can also accommodate for the
adjustability.
[0126] An addition to any of the embodiments described herein may
be adjustable set screws, wedges, or other appropriate means to
tighten and loosen the fit of the modular method socket onto the
amputee's residual limb. The means of having such adjustability may
vary in the ease of adjustability, cost, durability, and other
properties. These means may therefore be selected or avoided
altogether, based on the needs of the amputee, the environment, and
cost constraints.
Embodiments that Provide Adjustability with Regard to Length
[0127] Embodiments of height or length adjustable or extendable
members and/or width adjustable or extendable members may include
of one or more expandable or adjustable members that may adjust or
expand in height and/or width and may be added to, fastened to, or
integrated with the strut section. The additions may be riveted in
place, snapped on, manufactured as an integrated member within, or
otherwise fastened in an appropriate way. This allows for increased
variability to accommodate different lengths and sizes of the
residual limb, and may be used in conjunction with the other
adjustability and accommodative methods described herein. This
adjustable aspect of the design may also be omitted if not required
for certain amputees or for more simplified versions of the
design.
Embodiments of Linking Elements
[0128] Embodiments of structural struts or longitudinal links may
include structural weight bearing rigid or semi-rigid links or
struts that may be selected and adjusted to match the amputee's
needs. These links may be moldable or conformed for the patient by
heat molding, resin curing, or other conformable options. The
materials selected for these links may vary for the appropriate
location and use of the prosthetic socket. For example, for
developing country applications, locally available materials and
interfaces, such as aluminum, fiberglass, bamboo, and locally
available thermoset resins, may be selected.
Proximal Brim Embodiments
[0129] Embodiments of proximal brim members may include of one or
more rigid, semi-rigid, and/or flexible members that attach to the
struts. They may be adjustable or fixed dynamically or statically.
For example, connecting links may include a ratcheting section that
is patient adjustable, a fixed and contoured rigid section, a rigid
and non-contoured section, and a flexible section. They may be
designed to add support or control and/or allow for the full range
of motion for the particular patient. They may also be utilized for
suspension, such as a super condular proximal brim that suspends
proximal to the condyles of the patient's skeletal anatomy. The
proximal brim members of the modular and adjustable prosthetic
system may be custom made for the individual or prefabricated.
Prefabricated proximal brim sections are manufactured in such a way
that they are sized, contoured, and adjustable in such a way that
they can meet the needs of all or most amputees. This is
accomplished by utilizing specialized members with contours and
sizes that are appropriate for various sections of the socket and
the various amputation levels. Such proximal brim members may be
manufactured with various methods and materials that may vary per
application and location. The members are designed to have specific
shapes that work well to control movement of the prosthetic limb,
while still being comfortable and allowing range of motion to
facilitate the needs of different amputees. Such a proximal brim
may also vary in its application and design as well as associated
connection members and members that allow for adjustability of the
proximal brim members depending on the needs of the patient. For
example, the same proximal brim members may be selected for two
different amputees, but the method of attaching them to associated
members and adjustment pieces may vary. The base or default design
will have a standardized proximal brim shape that is contoured to
allow for muscle action and boney prominences that are typical for
each amputation level with overlapping and adjustable segments that
allow for adjustability that adapts to the patient's residual limb
shape and size. An adjustable section may also involve a strapping
or tying section and/or ladder and ratchet or other suitable system
to allow for adjustability of the size of the brim design. The brim
may include a moldable material that may be molded and remolded by
heat, curable resin, or other suitable way to match the specific
shape needs of the particular patient.
Additional Member Embodiments
[0130] Embodiments of a prosthetic socket, as provided herein, may
include additional members such as, by way of example: ischial
weight bearing seat extension members, tendon bearing extension
members, supercondular extension members, support or control
extension members, sensor members, levelometer members,
accelerometer members, microprocessor members, automated or manual
controlling members, padding or cushion members, lanyard suspension
system members, pull-bag or pull-sock exit tubes suspension system
members, pull-in sock or bag holding system for pull in and tie off
suspension system members, suspension belt members, suction valve
members, sealing sleeves or sealing system members, outside liner
members, cosmetic and/or functional fairing members, sweat
expulsion valve members, self alignable distal attachment member,
open compatibility distal attachments, adjustable flexion-extension
and adduction-abduction capable attachment components, total
surface-bearing or increased surface-bearing members, additional
strut or additional control cross-link members, and/or any other
appropriate additions. Members such as these are elaborated on in
greater detail below.
Ischial Weight Bearing Seat Extension Members
[0131] Embodiments of ischial weight bearing seat extension members
are extensions to the struts and/or the proximal brim described
above. Such members are designed and shaped to allow for weight
bearing or additional support or control of the prosthesis by
fitting under or applying pressure to the inferior aspect and/or
medial aspect of the ischial tuberosity. This anatomical structure
is a well-established weight bearing area, and is a pressure
tolerant area for many amputees. Additionally, because of its
connection with the spinal column, it serves as an effective means
for stabilizing the prosthesis and controlling the prosthesis as
the amputee moves his or her body. Since the anatomical shape and
size of amputees varies, as well as their pressure sensitivity and
needs, the ischial weight bearing seat extension members may vary
in pre-fabricated sizes and shapes. Additionally, such a member may
be custom fabricated or be prefabricated, with part or the entire
member formed from a moldable and/or adjustable material. The
member may be used with the prosthetic system described above for
different amputation levels, but will be most applicable for
trans-femoral amputees and hip-disarticulation amputees. The member
may be attached and adjusted in any appropriate manner. Adjustment
or function of the additional member may be automated or
manual.
Tendon Bearing Extension Members
[0132] Embodiments of tendon bearing extension members may include
extensions to the struts and/or the proximal brim described above.
Such members are designed and shaped to allow for weight bearing or
additional support or control of the prosthesis by applying
pressure to one or more tendons. For example, for trans-tibial
amputees, the patellar tendon is well established as a weight
bearing or weight tolerant area. Therefore, the bearing extension
members can be specifically configured and fit to apply pressure at
the patellar tendon in order to distribute pressure from weight
bearing at a pressure tolerant area. Since the anatomical shape and
size of amputees varies, as well as their pressure sensitivity and
needs, the bearing extension members may vary in pre-fabricated
sizes and shapes. Additionally, this member may also be custom
fabricated or be prefabricated, with part or all of the member
formed from a moldable and/or adjustable material. The member may
be used with the prosthetic system described above for different
amputation levels, but will be most applicable for trans-tibial
amputees. The member may be attached and adjusted in any
appropriate manner. Adjustment or function of the additional member
may be automated or manual.
Supercondular Extension Members
[0133] Embodiments of supercondular extension members can be
extensions to the distal cup, struts, and/or the proximal brims
described above. Such members are designed and shaped to allow for
suspension and/or additional support or control of the prosthesis
by applying pressure to one or more of the areas directly proximal
to or above the condyles of the amputated bone, adjacent bone, or
proximal bones. For example, trans-tibial amputees with short
residual limbs or limbs with redundant tissue sometimes need
additional medial-lateral control in order to adequately control
the prosthesis. Therefore, the supercondular extension members can
be specifically configured and fit to apply pressure at the area
directly proximal to or above the condyles of the femur in order to
distribute pressure from weight bearing at a pressure tolerant
area. Since the anatomical shape and size of amputees varies, as
well as their pressure sensitivity and needs, the supercondular
extension members may vary in pre-fabricated sizes and shapes. This
member may also be custom fabricated or prefabricated, with part or
the entire member formed from a moldable and/or adjustable
material. The member may be used with the prosthetic system
described herein for different amputation levels, but will be most
applicable for trans-tibial amputees, Symes amputees,
wrist-disarticulation amputees, and trans-radial amputees. In some
cases, it may be necessary to have an additional members associated
with the supercondular extension members to allow for the
supercondular section to be adjustable and/or removable.
Adjustability can provide the advantage of being able to vary how
much support or control is used, and/or removability of the
supercondular extension members can be required for donning and
doffing. The member may be attached and adjusted in any appropriate
manner. Adjustment or function of such an additional member may be
automated or manual.
Support or Control Extension Members
[0134] Embodiments of support or control extension members may
include any one or multiple extensions to any other members or part
therein. The members are designed and shaped to provide or aid in
suspension and/or additional support or control of the prosthesis.
Such a member may be attached and adjusted in any appropriate
manner. Adjustment or function of such an additional member may be
automated or manual. Since the anatomical shape and size of
amputees varies, as well as their pressure sensitivity and needs,
support and control members may vary in pre-fabricated sizes and
shapes. Additionally, this member may also be custom fabricated or
be prefabricated, with part the member or the entirety of the
member being formed of a moldable and/or adjustable material. The
member may be used with the prosthetic system described herein.
Sensor Members
[0135] Embodiments of sensor members may include an additional
member of the modular and adjustable prosthetic system that allows
for some form of determination or calculation of the amount of
force, torque, load, and/or pressure being applied at one or more
members and/or parts and/or portions of members. The force sensor
member can sense, determine, or calculate the amount of force,
torque, load, and/or pressure in many different ways, including, by
way of example, in-line load cells, pancake load cells, rotary
shaft torque sensors, and flush threaded pressure sensors. Data
that is collected from the sensors may be relayed to a remote or
onboard microprocessor unit for immediate or future use, and/or
stored or saved remotely or onboard the modular and adjustable
system. The member may be attached and adjusted in any appropriate
manner. Adjustment or function of such an additional member may be
automated or manual.
Inclinometer Members
[0136] Embodiments of inclinometer members may be integrated with
or added to the modular and adjustable prosthetic system. Such a
member may be attached and adjusted in any appropriate manner.
Adjustment or function of the additional member may be automated or
manual. Measurements of angles with respect to gravity for the
prosthetic system can be used to help avoid a fall for the amputee,
or help with the ability to navigate stairs, ramps, hills, or other
obstacles. These measurements may be relayed to a microprocessor
unit that may be integrated into the prosthetic system, attached,
and/or remote.
[0137] An inclinometer or clinometer is an instrument for measuring
angles of slope (or tilt), elevation or depression of an object
with respect to gravity. It is also known as a tilt meter, tilt
indicator, slope alert, slope gauge, gradient meter, gradiometer,
level gauge, level meter, declinometer, and pitch and roll
indicator. Clinometers measure both inclines (positive slopes, as
seen by an observer looking upwards) and declines (negative slopes,
as seen by an observer looking downward).
Accelerometer Members
[0138] Embodiments of accelerometer members may be integrated with
or added to the modular and adjustable prosthetic system. Such a
member may be attached and adjusted in any appropriate manner.
Adjustment or function of the additional member may be automated or
manual. Measurements of acceleration for the prosthetic system can
be used to help avoid a fall or accident for the amputee, or help
with the ability to navigate stairs, ramps, hills, or other
obstacles. These measurements may be relayed to a microprocessor
unit that may be integrated into the prosthetic system, attached,
and/or remote.
[0139] An accelerometer is a device that measures the proper
acceleration of the device. This is not necessarily the same as the
coordinate acceleration (change of velocity of the device in
space), but is rather the type of acceleration associated with the
phenomenon of weight experienced by a test mass that resides in the
frame of reference of the accelerometer device.
Gyroscopic Members
[0140] Embodiments of gyroscope members may be integrated with or
added to the modular and adjustable prosthetic system described
herein. Such a member may be attached and adjusted in any
appropriate manner. Adjustment or function of the additional member
may be automated or manual. Measurements or maintaining orientation
for the prosthetic system may be used to help avoid a fall or
accident for the amputee, or help with the ability to navigate
stairs, ramps, hills, or other obstacles. These measurements may be
relayed to a microprocessor unit that may be integrated into the
prosthetic system, attached, and/or remote.
[0141] A gyroscope is a device for measuring or maintaining
orientation, based on the principles of conservation of angular
momentum. In essence, a mechanical gyroscope is a spinning wheel or
disk whose axle is free to take any orientation. This orientation
changes much less in response to a given external torque than it
would without the large angular momentum associated with the
gyroscope's high rate of spin. Since external torque is minimized
by mounting the device in gimbals, its orientation remains nearly
fixed, regardless of any motion of the platform on which it is
mounted.
[0142] Gyroscopes based on other operating principles may also be
used, such as the electronic, microchip-packaged MEMS gyroscope
devices found in consumer electronic devices, solid-state ring
lasers, fiber optic gyroscopes, and extremely sensitive quantum
gyroscopes.
Weight-Bearing Surfaces
[0143] A total surface bearing interface may augment the modular
support frame of the modular member socket for those who require a
circumferential or total surface-bearing prosthetic socket. The
interface may also be utilized to increase the weight-bearing
areas, but not necessarily provide total surface-bearing. This
interface may vary in its material and application, but may include
a light but strong nylon or composite material similar to those
found in backpacks. It may be a curable material that may be set to
a given shape, may be made from a low temperature material that may
be molded directly over the residual limb, or may be made in any
other suitable way. The material of the interface may be flexible
or rigid, and may span part of the socket or the entire socket
area. These interfaces may be fit within the modular socket, or
they may be formed or ordered separately and then inserted. The
means for integrating such an interface with the modular socket may
vary, but may include an integrated or separately attached snap,
Velcro, or ratchet system to lock it into place in the structural
modular frame.
Flexible Inner Liners
[0144] Other versions of the invention may utilize flexible inner
liners or flexible inner brims. These members may or may not be
total surface-bearing, as described above, but may be made in a
similar way as listed for the interface. A flexible brim may be
fabricated separately after establishing the frame, or integrated,
and provides added comfort at the brim of the prosthesis without
needing to cover the entire residual limb. This allows for
increased comfort without adding unnecessary weight to the
prosthesis.
Combined Use of Pre-Fabricated and Custom-Fabricated Frame
Members
[0145] The embodiments of the methods, resulting products, and
designs described herein can be utilized as a hybrid of
custom-fabricated and pre-fabricated members. Additionally, aspects
of this modular method and system may be utilized to augment, add,
or be compatible with traditional or common methods of fabricating
a prosthesis. For example, a prosthetist may choose to fabricate
using traditional means, but may want to incorporate an adjustable
member from the modular method and system. Certain modular method
members can be designed to work like this.
[0146] Typical embodiments described herein are custom made, custom
assembled, and/or custom adjusted for optimal results, however,
some embodiments include pre-made and preassembled version of the
design could be ideal and self-contained without the need for
alteration by a trained professional. This could be true for
individual instances, or there could be an alternative embodiment
of the general module that is user adjustable and otherwise
prepared for application and use by the amputee. The alternative
embodiments may utilize one or more aspects of the embodiments
described herein.
Connecting and Adjusting Mechanisms
[0147] One or more of the parts, methods, members, or aspects
within the overall invention described here may be utilized
independently with other designs or methods. For example, one of
the hinges, fastening mechanisms, ratcheting systems, adjustable
systems, or automated control systems specially designed for this
modular method of prosthetic sockets may be sold separately for
integrated use with traditional fabricating methods.
Use of Low Durometer Silicone
[0148] Additional material, such as low durometer silicone, may be
added to the inside of the modular members to provide a surface
that will help to maintain suspension of the residual limb inside
the socket and avoid pistoning of the residual limb.
Frame Member Features
[0149] The modular method may include one or more oval shaped
structural struts that are different than previously discussed in
that they are shaped such that their cross section looks like an
oval or an almond with rounded ends. Advantages to this type of
strut include that it could be strong yet light, that its rounded
edges and dual convex outer surface shape provide an ideal pressure
distribution and safe edge surface, the bulkiness is limited, and
it has great ability for adjustability and compatibility. The
almond shaped structural strut alternative may be solid or hollow,
may vary in flexibility, material, adjustability (adjustability may
come from material capabilities and/or mechanical design
capabilities), size, and exact shape.
[0150] A standard or set of standards can be chosen and maintained
as consistent in order to be compatible with accompanying members.
For example, the almond shaped structural members may have a 1
"width version and a 1.5" width version and be fabricated to work
with compatible angular change members, hinges, adjustable hinges,
joining members, crossbeam members, adjustable extensions, proximal
brim connection members, distal member connection members, sensors,
etc. For example, one almond shape structural strut member may be
anchored to a distal base member with an adjustable hinge, then it
may apply a medially directed force onto the patient's residual
limb through the middle part of the residual limb. It may be joined
with a [Upsilon]' type joining member that connects it with two
other almond shape structural strut members who divert pressure
away from the amputee's fibula head, and then join with the
proximal brim member. The almond shape structural strut members may
include pressure distribution pads that are adjustable with use of
wedges, set screws, or other adjustable means.
[0151] The adjustability and compatibility of the almond shape
structural strut members may include any one or more of the
following: mechanical angular change capabilities (such as
accordion type angular changes, tilt angular changes, bowing
angular changes, twisting angular changes, etc.), conformability of
material capabilities, and use of compatible connection members.
For this embodiment or for any of the other embodiments described
herein, one or more of the members involved in the modular method
socket may also be utilized as a functional or aesthetic extension
from the socket. For example, the type of oval or almond shaped
strut system in this embodiment may also be utilized to extend past
the distal socket member and thereby serve as a modular pylon
system as well. Such a system may also become the foot or part of
the distal components and terminal device. The advantage of such a
system is that the whole prosthetic system then works as a
comprehensive system, thereby improving energy transfer and
efficiency. This embodiment exemplifies that these modular methods
and members may be extended to the use of the entire prosthetic
limb. Having a congruent system that works directly with the
modular members of the modular method system provides an advantage
over the current alignment components, joints, and terminal devices
that are available. What is more, the almond shape structural strut
members may be used for other significant applications such as, by
way of example, orthotics, robotics, and human exoskeleton
systems.
Dynamic Tightening or Compression
[0152] The modular method may include a dynamic tightening or
compression from the struts. For example, spring loaded hinge
members or other means of dynamic compression may be used to
connect to strut members to provide a desired amount of compression
on the amputee's residual limb. This can be desirable in that it
can improve suspension and control of the prosthesis. This
embodiment can also function similarly to a Chinese finger trap, in
that the further the amputee's residual limb is pushed down into
the modular socket, the more resulting suspension and snug fit the
amputee receives.
Specialized Hinges and Adjustable Members
[0153] The modular method may include one or more specialized
hinges or adjustable members that are specifically designed and
selected to work with elevated vacuum socket systems utilized in
prosthetics. For example, the modular hinges may be selected as
being low-profile and free-motion so that the compression and fit
that is established from the elevated vacuum system can be what
determines the relative position and contours of the socket. In
this example, the modular socket may be wider or narrower as
needed, depending on the current size of the amputee's residual
limb, while the elevated vacuum provides the appropriate amount of
compression, control, and suspension. This is an advantage over the
prior art in that the socket will more easily change with the
amputee if the size or shape of their residual limb changes.
Microprocessor Members for Adjustability, Adaptability, and
Operability
[0154] Embodiments of microprocessor members may include an
additional member of the modular and adjustable prosthetic system
that allows for some form of determination or calculation of the
amount of force or pressure being applied at one or members and/or
parts and/or portions of members. The force sensor member may
sense, determine, or calculate the amount of force or pressure in a
variety of ways. The member may be attached and adjusted in any
appropriate or effective manner, either manually or
automatically.
[0155] The microprocessor unit can be programmed to use these
measurements to make appropriate changes in the socket for specific
activities, aid in controlling components distal to the prosthetic
socket (such as a knee, foot, or elbow), or relay and collaborate
with other sensors and control mechanisms distal to the socket.
These are advantageous capabilities for prosthetic limbs, because
they allow for orientation, angle, and positional information and
adjustability options within, and at the level of, the prosthetics
socket. The capability or capabilities of using one or more of the
member options described above may be combined with microprocessor
and sensor capabilities at the distal componentry to provide a new
level of artificial limb awareness and ability. The advantage of
the system having orientation, angle, and positional information
and adjustability options is beneficially analogous to normal human
locomotion, which also uses neural sensors and the central nervous
system to process this information in order to know how to move and
react to the surroundings properly.
[0156] The modular method may include one or more microprocessor
control options that are designed and programmed to communicate and
work together or in conjunction with other components of the
prosthesis. For example, microprocessors utilized to adjust the fit
and function in the socket may communicate with the prosthetic knee
and/or prosthetic foot. Fit can be customized are adaptable as may
be appropriate for a specific activity, environment, or position of
the prosthesis. For example, an amputee may need his or her socket
to fit more snugly when they are running in order for the socket to
be more safe and secure, or the socket may automatically loosen at
the posterior when the amputee is sitting, for increased
comfort.
[0157] Embodiments of automated or manual controlling members may
include an additional member of the modular and adjustable
prosthetic system that provides means for controlling, moving,
limiting, or guiding one or more members and/or parts and/or
portions of members. For example, the automated controlling members
may be a motorized hinge system that automatically controls the
angle of the strut member in relation to the distal cup by a
motorized ladder and ratchet system controlled by the
microprocessor. Alternatively, the manual controlling members may
be a hand driven ratchet and ladder system or an adjustable hinge
mechanism. The automated or manual controlling members may be
integrated into one or more of the other members described herein.
The member may be attached and adjusted in any appropriate
manner.
[0158] Microprocessor control may be utilized to control the
adjustability or movement of one or more of the members involved in
the modular member socket. For example, one or more automated
control hinges may be controlled by a microprocessor. This
microprocessor may collect data from sensors inside the socket
and/or outside the socket, and have an option of communicating with
other microprocessors such as microprocessor-controlled knees and
feet. These data may then be used to adjust the socket fit to be
appropriate for the needs of the patient. For example, if the
patient starts running, the socket may tighten to increase control
and suspension, or if the patient is sitting, the socket can loosen
for increased sitting comfort.
[0159] Microprocessor control and other aspects of the modular
system may be incorporated into other parts of the prosthesis and
other systems beyond the socket per se. For example, the
microprocessor that helps to control movements or adjustments in
the socket may communicate with and cooperate with other parts of
the prosthesis, such as the knee and foot. The modular socket
design may incorporate an adjustable tension cable that is
integrated with and adjusted at the level of the modular alignment
pylon. Additionally, the connection member may be assembled with
modular alignment members that are made specifically to add to or
assist in the functioning of the modular socket system.
Use of a Dynamic Jig in Fabrication of a Residual Limb Socket
[0160] The embodiments of the methods, resulting products, and
designs described herein may also be utilized as dynamic jig
methods for setting processes of a direct fit system and/or as a
casting aid for a prosthetic socket. For example, the same or
similar modular members described herein to make a finished socket
may also be used as a way to form a weight-bearing cast or mold of
the residual limb or a direct fit socket. This may be especially
useful when a total surface-bearing socket is required or
preferred. The direct fit socket may be made of a carbon,
fiberglass, Kevlar, or composite material with pre-impregnated
resin that may be catalyzed at the desired time with UV, water, or
other suitable means. Other novel and specialty aspects to this
direct fit material and method may be incorporated, such as a
trimmable and Tollable edge, the ability to heat relieve and adjust
the socket, the ability to have built-in modular and adjustable
options, and the ability to have selected rigidity in selected
areas. This system is advantageous over prior art in that it allows
for static and dynamic testing for the comfort of the socket before
the socket is hardened. Therefore, a patient can try the socket fit
with the direct fit material in place and the modular members
supporting and controlling the fit of the direct fit material in
the appropriate locations, and then the socket may be adjusted
using the modular method adjustability if the patient is
experiencing discomfort anywhere. Then at the desired time, the
direct fit socket may be catalyzed. The advantage that this method
has over just sticking with the modular supporting frame is that it
may allow for the socket to be lighter and less bulky without the
supporting and adjustable features. Alternatively, a middle ground
can be utilized where part of the modular frame is used, or part of
the adjustability of the modular system is used and part of the
direct fit sleek and light frame is used.
Residual Limb Measurement Approaches
[0161] The modular method may include a step of scanning,
photographing, casting, three-dimensional point reference system,
or other means of obtaining a three-dimensional digital or physical
representation of the residual limb. A physical or digital positive
representation of the amputee's residual limb may then be utilized
to fabricate one or more custom contoured members, such members
including, for example, custom fabricated struts, connecting
members, adjustable members, distal base members, proximal brim
members, or any other member. These custom members may be
manufactured using direct manufacturing, three-dimensional
printers, lamination, injection molding, or other suitable or
preferred manufacturing or fabricating methods. In any case, the
end product is a custom modular prosthetic socket that is then fit
directly to the patient.
[0162] This alternative embodiment of the present invention offers
the option of custom making the members based on that positive
representation and other patient evaluation information, such as
weight and activity level, with the expense of adding complexity,
time, and cost to the process of creating the modular method
socket. This alternative embodiment may be ideal for certain cases
where custom fit and custom adjusted premade members will not serve
the needs of the patient. It may also be chosen when the increased
complexity, time, and cost are not an issue.
[0163] This alternative embodiment of a custom modular prosthetic
socket still has advantages over the prior art in that it reduces
the complexity of fabrication, because the same manufacturing
techniques, machines, and materials used for the premade members
may be used to fabricate the custom made members. They may be
fabricated as individual members, then assembled and adjusted to
meet the patient's needs. The alternative embodiment still offers
the advantages that come with modular methods, as well as increased
adjustability by both the practitioner and the patient. The modular
methods make it easier to get a good fit of the prosthetic socket
because of the inherent adjustability and modularity of the socket
after fabrication takes place.
Covers and Fairings
[0164] Embodiments of a modular method socket, as provided herein,
may include a cosmetic cover or aesthetic fairing. This cosmetic
cover or aesthetic fairing may be made to connect to and be
compatible with the rest of the modular method socket. This
cosmetic cover or aesthetic fairing may be complex and expensive
when made with state of the art materials, or relatively simple and
inexpensive when made with low-cost materials. For example,
prefabricated wrap-around cosmetic covers that are in the shape of
a calf may be made of color appropriate low-density polyethylene to
produce a low cost, water resistant, and durable solution.
Incorporation of Advanced Materials and Available Materials
[0165] The embodiments of the methods, resulting products, and
designs described herein may be manufactured with advanced
materials and manufacturing techniques and/or precision machinery,
including 3D printing technology.
[0166] Other versions may utilize desired combinations of newly
invented and previously introduced materials, manufacturing
capabilities, joints, hinges, user adjustability, microprocessor
control, automated or manual adjustment control, adjustable
options, and other emerging technologies. Being able to utilize
these emerging technologies and specialized parts that can be
manufactured in a selected and interchangeable way, then
incorporated into the basic modular prosthetic socket method, is
one of the benefits of this method and an advantage over the prior
art. This modular system can more easily incorporate new
technology.
[0167] The embodiments of the methods, resulting products, and
designs described herein may be manufactured with basic materials
and manufacturing techniques that can be made in affordable and
locally sustainable ways. This can be ideal for developing world
applications. Alternative forms of the invention include using
low-cost, sustainable, and locally available materials (such as
bamboo) for developing country applications. This can be especially
beneficial for the tens of thousands of amputees who go without
prostheses in developing countries. Other aspects to the present
invention, like easier training, faster deployment, less space,
fewer tools, and the like, make the present invention applicable to
developing countries and relief situations. The desired method of
distribution can be something like what is done with the Tom's
Shoes system, where for each modular method prosthesis or
prosthetic socket that is purchased in a developed country; someone
who cannot afford a limb gets fit with one in a developing
country.
Particular Advantages of Embodiments of the Invention
[0168] The following aspects of the invention, as provided herein,
may be understood as being advantageous, with particular reference
to conventional fabrication processes that are reliant on molding
steps or on direct fit limb socket approaches that have been
attempted to this point.
[0169] 1. Method embodiments of the invention, as described herein,
are highly efficient in terms of required time and resources. These
aspects of the invention favor it economically, within any economy,
but the relevance is increased in environments where resources are
limited.
[0170] 2. Embodiments of the invention little space and little
machinery to deliver custom-fitted sockets. These advantages have
particular relevance in emergency relief situations where
infrastructure has yet to be reestablished following a natural or
man-made disaster.
[0171] 3. Embodiments of the invention provide adjustability
features that extend beyond the capabilities associated with a
bivalve arrangement, telescoping features, or circumferential
wrapping design. In particular, the adjustability of the socket may
be assembled for a changing pressure profile that matches the
patient's changing needs over time.
[0172] 4. Embodiments of the invention provide the capability for
the residual limb socket to adjust for volume fluctuation in the
residual limb, and are highly adaptable for different limb sizes
and shapes. This is due to the fact that the individual members are
selected and assembled to meet the needs of the individual amputee.
Hence, the angles and contours of the selected members may be
oriented and assembled to meet the needs of virtually any
amputee.
[0173] 5. Embodiments of the invention require relatively brief
training for successful delivery and follow-up. The method also has
a relatively low level of complexity for what the trained
healthcare professionals are required to do in order to fabricate
and fit the amputee.
[0174] 6. Embodiments of the invention advantageously provide for
enhanced ability to dissipate heat and perspired and environmental
moisture.
[0175] 7. Embodiments of the invention are highly adaptable or
compatible to any given or conventional mechanism by which
suspension of the prosthetic is achieved.
[0176] 8. Embodiments of the invention, as methods for making a
residual limb socket do not necessarily require electrical power to
implement.
[0177] 9. Embodiments of the invention are advantageously able to
use desired combinations of conventional and new materials, joints,
hinges, user adjustability, the microprocessor control, automated
or manual adjustment control, and adjustable options. The
specialized parts may be manufactured in a selected and
interchangeable way that is easier to manufacture than current
designs.
[0178] 10. Embodiments of the invention allow for user empowerment
and control regarding adjustability, repair, and other user
controllability over the operability of their prosthetic socket and
complete assembly, as may be appropriate.
[0179] 11. Embodiments of the invention provide a quick route to
get the product to a point of a trial fitting on the amputee, and
to make changes as may by appropriate per the trial fitting.
[0180] 12. Embodiments of the invention have a modular assembly
aspect that allow it to adapt and work well with emerging surgical,
biological, and technical advancements, as represented, for
example, by implants and osseointegrated devices.
[0181] 13. Embodiments of the invention, by virtue of having a
short manufacturing time, release available time for training,
therapy, and instructions on care, use, and follow-up. Allowing
more time to address these goals positively affects patient
outcomes.
[0182] 14. Embodiments of the invention allow for various types of
socket shapes and various options for pressure profile
distribution, as well as the modular and adjustable ability to
change as the patient changes.
[0183] 15. Embodiments of the invention may utilize CAD/CAM
technology, scanning and imagery technologies, and other shape
capturing technology, as well as 3D printing and other
manufacturing technology.
[0184] 16. Embodiments of the invention, in the absence of
mold-related steps and in view of minimal fabrication time, offer
the ability to test the prosthesis under its intended
weight-bearing conditions.
ILLUSTRATED EMBODIMENTS
[0185] FIG. 1 is a perspective view of an example of a right
above-knee (trans-femoral) prosthetic socket after the modular
members have been selected, assembled, formed, and adjusted to fit
over an individual's residual limb. Item 1 of FIG. 1 is an example
of a proximal brim member specially fabricated and engineered for
the anterior-medial aspect of the proximal brim for an above-knee
(trans-femoral) modular prosthetic socket after it has been formed
directly to match the individual's residual limb. Item 2 is an
example of a proximal brim member specially fabricated and
engineered for the ischial aspect of the proximal brim after it has
been formed directly to match the individual's residual limb
wherein it is engineered and fabricate to be able to form for
socket ischial containment. Item 3 is an example an encircling band
after it has been formed directly to match the individual's
residual limb. This particular example is a semi-rigid and formable
male telescoping member of an encircling band after it has been
formed to the individual's residual limb. This particular example
of an encircling band is an encircling band that is engineered to
be able to manually tighten or loosen as enabled by the rotary
tensioning mechanism 12 and internal tensioning cables that run
through the inside of the encircling band 3. Item 4 is an example
of a semi-rigid and formable female telescoping section of the
encircling band after it has been formed directly to the
individual's residual limb. Item 5 is an example of the inner
surface of a strut after it has been formed directly to the
individual's residual limb. This inner surface has an appropriate
material to match the individual's needs such as a silicone pad for
suspension and shock absorption as well as lateral moisture wicking
materials. Item 6 is an example of a second encircling band after
it has been formed directly to match the individual's residual
limb. A second encircling band has been added in this example as a
way to increase socket strength and strength of adjustability for a
high activity individual. Item 7 is an example of a strut after it
has been formed directly to contour to the individual's residual
limb. Item 8 is an example of a distal cup member after it has been
formed directly to fit the individual's residual limb. Item 9 is an
example of a set screw for strut telescoping mechanism 10 used to
set the desired height of the strut wherein the height of the strut
can be adjusted to match the needs of the individual person's
residual limb. Item 13 is two examples of a proximal brim member
specially fabricated and engineered for the lateral aspect of the
proximal brim for an above-knee (trans-femoral) modular prosthetic
socket after they have been formed directly to match the
individual's residual limb. Item 21 is an example of a distal
attachment member, to which distal ends of the struts 7 are
attached, and which is described in more detail in reference to
FIGS. 2 and 3.
[0186] FIG. 2 is a perspective view of an example of a right
above-knee (trans-femoral) prosthetic socket after the modular
members have been selected, assembled, molded, but before it has
been directly molded and adjusted to fit over an individual's
residual limb. Item 14 of FIG. 2 shows two examples of a proximal
brim member specially fabricated and engineered for the lateral
aspect of the proximal brim for an above-knee (trans-femoral)
modular prosthetic socket before they have been formed directly to
match the individual's residual limb. Item 15 is an example of a
proximal brim member specially fabricated and engineered for the
ischial aspect of the proximal brim for an above-knee
(trans-femoral) modular prosthetic socket before it has been formed
directly to match the individual's residual limb. Item 22 is an
example an encircling band before it has been formed directly to
match the individual's residual limb. This particular section is an
example a semi-rigid and formable female telescoping member of an
encircling band before it has been formed to the individual's
residual limb. This example of an encircling band is an encircling
band that is engineered to be able to manually tighten or loosen as
enabled by the rotary tensioning mechanism, 12 and internal
tensioning cables that run through the formable male, 23 and
female, 22 telescoping members and connect to the tensioning
mechanism. Item 18 is an example of a strut in its prefabricated
form before it has been formed directly to match the individual's
residual limb. Item 19 is an example of a distal cup in its
prefabricated form before it has been formed directly to match the
individual's residual limb. Item 20 is an example of distal portion
of a strut wherein this particular strut type has a metal base
which connects at an assembled distal attachment member 21 This
particular type of distal portion of a strut 20 is designed to be
adjustable in the angle by which it is mounted to the distal
attachment member 21 as well as being directly formable to the
individual. The compatible and adjustable relationship between this
distal portion of the strut 20 and the assembled distal attachment
member 21, is also an example of how the overall modular prosthetic
socket is engineered such that the separate specialized members
that can be selected from an inventory of specialized members to
custom match the end user's needs are engineered to be compatible
and/or adjustable to one another wherever appropriate. Item 24 is
an example of an inside surface of a strut before it has been
formed directly to match the contours of an individual's residual
limb and/or cut to an appropriate length for the individual's
residual limb. This inside surface of a strut member 24 includes a
shock absorbing material such as silicone as well as including
lateral wicking moisture channels. Like other strut surfaces, these
surface materials are engineered for ease of replacement in order
to provide simple methods to be able to add materials or components
that offer specific properties or attributes that are beneficial
for the end user. Item 25 is an example of a proximal brim member
specially fabricated and engineered for the anterior-lateral aspect
of the proximal brim for an above-knee (trans-femoral) modular
prosthetic socket before it has been formed directly to match the
individual's residual limb.
[0187] FIG. 3 is a frontal cross sectional view of an exploded
right above-knee (trans-femoral) prosthetic socket. This embodiment
provides encircling tensioning member with microprocessor control,
outside t-nuts to enable encircling wrap of fiberglass casting tape
or similar means to increase pressure distribution area in a
directly formable and low-cost way as well as provide a location to
attach a cosmetic cover. Item 15 of FIG. 3 is an example of a
proximal brim member specially fabricated and engineered for the
ischial aspect of the proximal brim for an above-knee
(trans-femoral) modular prosthetic socket before it has been
assembled and before it has been formed directly to match the
individual's residual limb. Item 27 is an example of an insertion
member of proximal brim member 15 wherein the insertion member is
fabricated and engineered to be compatible with the insertion
member of a proximal brim receiver 28 of the strut 18. The specific
mechanism of mounting a proximal brim member to the proximal aspect
of a strut may vary but this example demonstrates that the proximal
brim members are fabricated and engineered to be able to mount to
the proximal aspect of a strut. Item 22 is an example an encircling
band before it has been formed directly to match the individual's
residual limb. This particular section is an example a semi-rigid
and formable female telescoping member of an encircling band before
it has been formed to the individual's residual limb. This example
of an encircling band is an encircling band that is engineered to
be able to manually tighten or loosen as enabled by the tensioning
mechanism 12 and internal tensioning cables that run through the
formable male 23 and female 22 telescoping members and connect to
the tensioning mechanism. Item 29 is an example of a t-nut which is
mounted to the outside of strut 18 as a means to allow ease in
attachment of a cosmetic cover, tensioning system, encircling ring,
and/or to allow for the struts to be structurally reinforced as
well as increased in their surface area by an external
surface-bearing interface wrapping circumferentially around the
external surface of the struts with a direct formable fiberglass
casting tape or other applicable means for providing an increased
weight bearing surface area or total surface-bearing addition to
the struts in a way where the circumferential wrap can be easily
fixed to the struts by grinding the casting tape down to the top of
the t-nut after the casting tape has hardened and then screwing
rounded bolts into the t-nuts, or for affixing other beneficial
members. Item 20 is an example of distal portion of a strut wherein
this particular strut type has a metal base which connects at an
assembled distal attachment member 21. This particular type of
distal portion of a strut 20 is designed to be adjustable in the
angle by which it is mounted to the distal attachment member 21 as
well as being directly formable to the individual. Item 30 is an
example of the distal component of the resulting assembled distal
attachment member 21 wherein this distal component of the resulting
assembled distal attachment member 21 is fabricated and engineered
such that it has a serrated channel 31 to accommodate being joined
together with the serrated channel 31 of a proximal component 37 of
the resulting assembled distal attachment member 21 in order to
receive and attach the distal aspect of a strut 20 in the desired
location and angle, as well as drilled holes to accommodate
standard endoskeletal alignment components and moisture evacuation
channel/s and/or suspension channel 33. Item 32 is an example of a
distal attachment bolt which is used to join a modular alignment
mechanism together with proximal and distal components of the
resulting assembled distal attachment member 21. Item 33 is an
example of a moisture evacuation channel/s and/or suspension
channel which is incorporated into the assembled distal attachment
member 21, distal cup, end pad, flexible inner liner and/or other
distal members in order to allow the modular prosthetic socket to
be compatible with existing methods of suspension such as shuttle
locks and moisture management as well as allow for proprietary
members for means of suspension and moisture management that the
inventors are currently working on such as specialized locking
mechanisms with air seal, oneway valve/s, and specialized moisture
channels. Item 34 is an example of an attachment bolt which is used
to join a distal cup together with an assembled distal attachment
member 21. Item 35 is an example of a modular alignment component
that is compatible with commonly used endoskeletal prosthetic
alignment systems. Item 37 is an example of the proximal component
of the resulting assembled distal attachment member 21 wherein this
proximal component of the resulting assembled distal attachment
member 21 is fabricated and engineered in order to receive and
attach the distal aspect of a strut 20 in the desired location and
angle, as well as drilled and tapped holes to accommodate standard
endoskeletal alignment components, distal cup, and moisture
evacuation channel/s and/or suspension channel 33. Item 38 is an
example of a prefabricated direct formable distal end pad with a
moisture evacuation channel/s and/or suspension channel 33 before
it has been formed to the distal end of the residual limb such that
it contours the distal end of the limb to avoid skin irritation and
provides shock absorption for the individual user's residual limb.
Item 19 is an example of a distal cup before it has been formed
directly to match the individual's residual limb. Item 10 is an
example of the strut telescoping mechanism wherein the height of
the strut can be adjusted to match the needs of the individual
person.
[0188] FIG. 4 is a frontal cross sectional view of the above-knee
(trans-femoral) prosthetic socket shown exploded in FIG. 3 after it
has been assembled and including a total surface-bearing flexible
inner liner after it has been assembled and formed to the
individual's residual limb. Item 39 in FIG. 4 is an example of an
adjustable seam for the directly formable wraparound longitudinal
member of a direct formable total surface-bearing flexible inner
liner 44 which allows the wrap-around type longitudinal member of a
direct formable total surface-bearing flexible inner liner 44 to be
wrapped around the longitudinal aspect of the limb and seal at an
overlap for the appropriate circumference of the individual's
residual limb after the distal cup member for the direct formable
total surface-bearing and flexible inner liner 47 has been formed.
Item 44 is also meant to point out the entirety of an assembled
direct formable total surface-bearing flexible inner liner after it
has been direct formed to match the size and contour of an
individual's residual limb. Fabricating and engineering this
directly formable wrap-around type longitudinal member provides the
advantage that it can accommodate a wide array of limb shapes and
sizes due to the wrap-around fitting method that it facilitates.
Item 40 is an example of a proximal trimline for the directly
formable wrap-around type longitudinal member of a direct formable
total surface-bearing flexible inner liner 44 after it has been
trimmed to match the residual limb length and functional needs of
the individual's residual limb and after a non-abrasive and rolled
edge has been incorporated into this proximal trimline 40. Item 42
is an example of an inner and outer sealing member for the directly
formable wrap-around type longitudinal member of a direct formable
total surface-bearing flexible inner liner 44 after it has been
direct formed to the individual's residual limb wherein the inner
and outer sealing member 42 aids in suspension of the residual
limb. Item 43 is an example of an assembled modular prosthetic
socket after the modular socket members have been selected and it
has been assembled and then direct formed to match the needs of the
individual and the individual's residual limb wherein the
individually selected modular socket members of the modular
prosthetic socket have been shown in an exploded view and
individually called out in FIG. 3. Item 45 is a distal sealing
member for the directly formable wrap-around type longitudinal
member for a direct formable total surface-bearing flexible inner
liner 44 wherein the distal seal allows for the directly formable
wrap-around type longitudinal member for a direct formable total
surface-bearing flexible inner liner 44 to be attached to and
create an air-tight seal with the direct formable distal cup member
for the direct formable total surface-bearing and flexible inner
liner 47 after they have been directly formed to fit the
individual's residual limb. Item 48 is an direct formable distal
end pad of the direct formable distal cup member 47 that is
fabricated and engineered to include means for direct forming to an
individual's residual limb by allowing pre-filled air, foam, and/or
other applicable contents to evacuate the sealed chamber by way of
an expulsion valve as the end pad is pressed onto the distal end of
the residual limb for direct forming. If the distal end of the
residual limb gets smaller, air, foam, or other applicable material
is allowed to re-enter the sealed chamber of the direct formable
distal end pad 48 passively through the expulsion valve or it is
injected with applicable contents until it meets the distal end of
the amputee's residual limb. Therefore, this example of a direct
formable distal end pad is not only custom shaped to the distal end
of the individual's residual limb, it is also a custom end pad that
can change with the individual as their limb changes with time.
Item 49 is an example of an enclosed and assembled serrated channel
with a distal portion of a strut is placed in the enclosed and
assembled serrated channel 49 at the desired takeoff angle. Item 21
is an example of an assembled distal attachment member wherein the
distal attachment members shown here is fabricated and engineered
to be able to assemble in such a way that it can receive and
securely mount the distal aspect of a strut as well as a distal cup
and modular alignment components. Item 52 is an example of a
microprocessor unit, means of communication linking between other
independent sensors and microprocessors, and internal sensors
wherein it has been joined with a rotary tensioning mechanism 12.
This microprocessor unit and accompanying sensors and means of
communication 52 allows for collection of data, communication of
data, and interpretation of data that provides the ability for
automated control of socket tightening and loosening by means of
the rotary tensioning mechanism 12 as well as coordination between
other microprocessors and/or sensors located in other places on the
modular prosthetic socket or within distal componentry such as a
knee, foot, elbow, and/or hand. This communication with one or more
other microprocessor or sensors located on the modular prosthetic
socket provides the ability for coordinated tightening, loosening,
or other pressure profile changing means within different parts of
the modular prosthetic socket such as the direct foldable flexible
inner liner 44 and the side-mounted ratcheting lanyard suspension
mechanism 64. This ability for the modular prosthetic socket to
automatically tighten, loosen, or otherwise change its pressure
profile and to do so in a coordinated way with different aspects of
the allows for the modular prosthetic socket and direct formable
flexible inner liner 44 to automatically change its pressure
profile to match the user's preferences for specific activities
such as sitting or running. While this particular example uses a
rotary tension unit 12 and tensioning cables 53, as the means of
pressure profile change, other means of pressure profile change are
utilized to change the pressure profile such as phase changing
materials, rheo magnetic fluid materials, ratcheting device/s,
pulley systems, by application of heating or electrical current to
reform or change material properties, and/or other applicable
means. Item 54 is an example of a moisture evacuation channel/s
and/or suspension channel which is incorporated into the direct
formable distal cup member 47 and direct formable distal end pad 48
to allow the modular prosthetic socket to be compatible with
existing methods of suspension such as shuttle locks and moisture
management as well as allow for proprietary modular socket members
which offer means of suspension and/or moisture management. Item 55
is an example of an expulsion valve that can be used to expel air
or fluid and is integrated into the moisture evacuation channel/s
and/or suspension channel 54. Item 57 is an example of valve or
port that enables use of an elevated vacuum system. Item 58 is an
example of a pull cord for a side-mounted ratcheting lanyard
suspension mechanism 64. Item 59 is an example of ratcheting
teeth/tabs for a side-mounted ratcheting lanyard suspension
mechanism 64. Item 60 is an example of a housing unit for a
microprocessor controlled locking mechanism for a side-mounted
ratcheting lanyard suspension mechanism 64, sensors, and means of
communication with microprocessor 52 and/or other microprocessors.
Item 62 is an example of manual release button for the locking
mechanism for a side-mounted ratcheting lanyard suspension
mechanism 64. Item 63 represents a socket exit port which allows
the ratcheting lanyard to exit the modular prosthetic socket and
feed into the microprocessor controlled locking mechanism 60. Item
64 represents the overall side-mounted ratcheting lanyard
suspension mechanism and specifically points to where the
side-mounted ratcheting lanyard suspension mechanism 64 is bonded
to the direct formable total surface-bearing flexible inner liner
44.
[0189] FIG. 5 is a top view of an example of a right above-knee
(trans-femoral) prosthetic socket after the modular members have
been selected, assembled, molded, but before it has been adjusted
to fit over an individual's residual limb. This perspective gives a
clear view of an encircling tensioning member without
microprocessor control. Item 26 in this figure is an example of a
heating coil which is embedded into the strut in order to allow for
electrical current to pass through the heating coil 26 for the
purpose of temporarily or permanently changing the properties of
the strut. Item 14 shows two examples of a proximal brim member
specially fabricated and engineered for the lateral aspect of the
proximal brim for an above-knee (trans-femoral) modular prosthetic
socket before they have been formed directly to match the
individual's residual limb. Item 15 is an example of a proximal
brim member specially fabricated and engineered for the ischial
aspect of the proximal brim for an above-knee (trans-femoral)
modular prosthetic socket before it has been formed directly to
match the individual's residual limb wherein it is engineered and
fabricate to be able to form directly for ischial containment. Item
19 is an example of a distal cup in its prefabricated form before
it has been formed directly to match the individual's residual
limb. Item 22 is an example an encircling band before it has been
formed directly to match the individual's residual limb. This
particular section is an example a semi-rigid and formable female
telescoping member of an encircling band before it has been formed
to the individual's residual limb. Item 23 is an example a
semi-rigid and directly formable male telescoping member of the
encircling band 22 before it has been formed directly to the
individual's residual limb. Item 24 is an example of an inside
surface of a strut before it has been formed directly to match the
contours of an individual's residual limb and/or cut to an
appropriate length for the individual's residual limb. This inside
surface of a strut member, 24 includes a shock absorbing material
such as silicone as well as including lateral wicking moisture
channels. Like other modular surfaces material additions, these
surface materials are engineered for ease of replacement in order
to provide simple methods to be able to add materials or components
that offer specific properties or attributes that are beneficial
for the end user. Item 25 is an example of a proximal brim member
specially fabricated and engineered for the anterior-lateral aspect
of the proximal brim for an above-knee (trans-femoral) modular
prosthetic socket before it has been formed directly to match the
individual's residual limb. Item 38 is an example of a
prefabricated direct formable distal end pad with a moisture
evacuation channel/s and/or suspension channel 33 before it has
been formed to the distal end of the residual limb such that it
contours the distal end of the limb to avoid skin irritation and
provides shock absorption for the individual user's residual
limb.
[0190] FIG. 6 is a perspective view of an example of a below-knee
(trans-tibial) prosthetic socket. Item 65 in this figure is an
example of a proximal-medial brim member of the trans-tibial
modular socket. Item 67 in this figure is an example of a relief
cut-out for the distal tibia in the distal base member of the
trans-tibial modular socket. Item 66 is a joining member between a
medial strut member and proximal brim member 65 that allows height
and angular adjustment by use of sliding and wedging. Item 70 is an
adjustable strut to distal cup attachment mechanism. Item 35 is a
standard alignable modular pyramid connecter that is made to attach
to the distal cup 69. Item 72 is a ratcheting adjustable member.
Item 73 is the flared aspect of the posterior strut member of the
socket that is specifically designed for allowing for knee range of
motion.
[0191] FIG. 7 is a perspective view of an example of an above-elbow
(trans-humeral) prosthetic. Items 78 and 79 are the humeral and
forearm sections, respectively, of the prosthesis that are
connected to the modular socket. Item 74 is a sliding joint that
may be used to adjust anterior-posterior fit of the socket. Note
the difference between the strut 32 in FIG. 7 and adjustable
telescoping strut 85 in FIG. 8, demonstrating the option of
including strut member 85 that is adjustable in length via
telescoping and strut 75 that may be cut to length but are then a
fixed length. Item 77 is an adjustable attachment member used to
attach strut 75 to distal cup 80. Item 82 is a cross-strut member
that attaches to the anterior two struts of this modular prosthetic
socket in a horizontal orientation with respect to the long axis of
the amputated humerus bone for the purpose of optimizing
biomechanical control in flexion of the amputated humerus bone.
[0192] FIG. 8 is a perspective view of the same prosthetic sock as
seen in FIG. 7, after the after the proximal brim member 83 of FIG.
7 has been molded and trimmed to produce the formed and trimmed
proximal brim member 83 of FIG. 8 in order to allow for increased
range of motion. Moreover, FIG. 8 shows an example of the same
modular socket as in FIG. 7 wherein an addition of a horizontally
oriented adjustment member 84 offers greater user-adjustability by
means to tighten or loosen the proximal brim and proximal aspects
of the included telescoping strut 85. Adjustable proximal brim to
strut attachment mechanism 87 has also been added for increased
adjustability as compared to the modular socket of FIG. 7. Hence,
FIG. 8 in comparison with FIG. 7 offers an example of how modular
socket members can be added, changed, and/or adjusted to
accommodate the needs of the individual amputee.
[0193] FIG. 9 is a perspective view of an example of an above-knee
(trans-femoral) modular prosthetic socket after it has been formed
to an individual's residual limb, this particular example having a
cut-out in the strut member that allows for an encircling band to
sit flush. Item 95 shows a cut-out in the strut member 94, which
allows for the encircling band 88 to sit flush. The encircling band
88 serves as an adjustment member/tensioning member for the
proximal brim of the modular prosthetic socket. Item 89 shows a
proximal brim member for the lateral-posterior portion of the
socket. Item 92 shows an adjustable attachment member which
attaches a strut to the distal cup 93. Item 90 shows a proximal
brim member that is specialized to form an ischial weight-bearing
seat.
[0194] FIG. 10 is a perspective view of an example of an above-knee
(trans-femoral) modular prosthetic socket after it has been formed
to an individual's residual limb. Item 102 is an adjustable
attachment member which attaches strut member 103 to the distal cup
100. Item 97 is a proximal brim member designed and molded directly
to the user for the anterior-medial area of the proximal brim. Item
98 is a proximal brim member that is specially designed and molded
directly to the user to accommodate ischial containment control of
the user's residual limb. Item 99 is a non-adjustable proximal brim
member that connects the ischial containment proximal brim member
98 to the anterior-medial proximal brim member 97.
[0195] FIG. 11 is a perspective view of an example of a prosthetic
socket of the present invention. This drawing is an example of the
same right above-knee socket shown in FIG. 10, only the
none-adjustable proximal brim member of figure has been replaced
with adjustable proximal brim members 105 and 105. Item 107 shows
an alternative means of affixing the adjustable attachment member
which connects a strut to a distal cup wherein removable and
recessed bolts are used.
[0196] FIG. 12 is a perspective drawing of an example of a
prosthetic socket of the present invention. This drawing is an
example of a below-elbow socket, otherwise known as transradial
prosthetic socket. Item 84 is an adjustment slot in proximal brim
member 109 that allows for adjustability of the proximal brim
member 109. Proximal brim member 109 also has means for adjustable
supercondular clamping which is used as a means for support and
suspension. Item 110 is a direct formable total-contact flexible
inner liner which fits internally to the struts and proximal brim
members and interfaces with the residual limb to increase pressure
distribution. Item 115 is an adjustable attachment member. Item 112
is an attachment screw used as attachment means between a strut and
a proximal brim member. Item 113 is a distal cup and item 114 is a
distal attachment member.
[0197] FIG. 13 is a superior view of the distal cup of the Symes
(an ankle disarticulation socket) modular prosthetic socket as also
seen in side view in FIG. 14. Item 118 is a relief contour area of
the distal cup and Item 117 is a compressive contour in the distal
cup. These are examples that represent the fact that all members
are specially contoured and designed for their specific
applications. Item 116 is a moisture evacuation channel built into
the distal cup.
[0198] FIG. 14 is a side view of a prosthetic Symes socket (ankle
disarticulation socket), showing, in particular, a height
adjustable member with option for angular change. This drawing is
an example of a left Symes socket, otherwise known as an ankle
disarticulation prosthetic socket after the modular members have
been selected, assembled, molded, and adjusted to fit over an
individual's residual limb. Item 128 is a height adjustable member
with option for angular change. Item 126 is a distal push-in
suction socket distal silicone cup. Items 125 are set screws that
lock in the distal silicone cup 126. Item 122 is a relief for the
fibular head on the residual limb of the amputee (not shown). Item
129 is a proximal brim member designed and molded to the residual
limb of the amputee for the medial proximal aspect of the proximal
brim. Item 119 is a proximal brim member designed and molded to the
residual limb of the amputee for the patellar tendon area of the
proximal brim. Item 120 is a proximal brim member designed and
molded to the residual limb of the amputee for the lateral proximal
aspect of the proximal brim. Item 123 is an adjustable attachment
member. Item 124 is a distal attachment member. Item 129 is a
proximal brim member used for the medial aspect of the socket. Item
127 is a strut formed and used for the medial longitudinal axis
aspect of this prosthetic socket.
[0199] FIG. 15 is a perspective view of an above-knee
(trans-femoral) socket that shows detail of a proximal brim with an
adjustable section, as well as an ischial seat extension. This
perspective drawing is demonstrating the opportunity for different
members to be used and selected to match the needs of the
individual. An adjustable encircling band 133 can be used to
provide an adjustable proximal brim, or a fixed proximal brim 130
may be chosen. Item 132 is an ischial seat extension fastened with
adjustable screws 124 and including a shock absorbing silicone pad.
Item 135 is a cross-link member fixed to a strut by attachment
means 134 and 137 connecting between two struts for added strength
and biomechanical control. The adjustable encircling band 133 is a
proximal brim member designed to allow for tensioning/adjustment of
the proximal brim members. Item 128 is an attachment screw for
added cross link member 135. Item 138 shows a joining mechanism of
the proximal aspect of a strut which receives the adjustable
encircling band 133 and allows it to be attached flush with the
amputee's residual limb.
[0200] FIG. 16 is a perspective view of the distal portion of an
above-knee (trans-femoral) prosthetic socket, showing detail
related to an integrated suspension mechanism, and modular
alignment feature and a settable hinge. FIG. 16 shows the ability
for integrated suspension methods, such as item 144, an exit member
for a suspension pull bag and location for mounting a suction
valve. FIG. 16 further shows additional features that may be
integrated into the modular prosthetic socket of the present
invention to match the needs of the patient, such as adjustable
alignment mechanism 143 and adjustable and settable (can be fixed
at a desired position) hinges 139, 142, and 147. Item 140 is a
strut. Item 145 is a bolt used as means for attachment of
adjustable and settable hinge 147 to the distal cup.
[0201] FIGS. 17 and 18 are lateral cross-section drawings of
specialized, proprietary, modular, and adjustable connection
members that are fabricated and designed for specific purposes and
can be utilized for the modular prosthetic sockets and methods
described herein.
[0202] FIG. 17 shows lateral cross-section views of modular
adjustable joint and hinge options, showing an option of utilizing
wedges that may be removed or replaced to change the desired angle.
Item 150 of this figure shows a wedge that can be removed or
replaced to change the desired take-off angle of strut 148 relative
to distal cup 149 and secured in place by attachment rivet 149.
[0203] FIG. 18 shows a hinge with setscrew, hinge cover, and strut
wedge. FIG. 18 shows a hinge 162 with set screw 160 and hinge cover
158. Additionally, FIG. 18 shows the ability to add a wedge 154 or
filler pad 154 to the strut itself 156.
[0204] FIG. 19 is a superior perspective view of modular adjustable
joint ratchet options that may be utilized for the prosthetic
socket. Item 194 is a lock and release lever that snaps into a
holding slot 195. The other numbered items are as follows: 190 is a
means for the user to pull tension on the ratchet, 190 is the axis
by which the lock and release lever 194 rotates, 196 is the portion
of the ratchet strap which has holding slots 195 which can snap
into the lock and release lever 194, 198 is the portion of the
ratchet strap which connects to 196 and does not have holding slots
195 but can transfer or hold tension for the ratchet system. FIG.
16 shows a set screw 174 that can change the angle of the Y shaped
strut 166 along with wedges such as wedge 168.
[0205] FIG. 20 shows an adjustable hinge with the additional
features of retainer members as well as having the entire set beam
member being a separate member that may be placed separately and
set into place. FIG. 21 shows an adjustable hinge similar to that
of FIG. 20, with the additional features of retainer members 218
and 222 as well as having the entire set beam member 216 being a
separate member that may be placed separately and set into place
with elements 226 and 214. One advantage of this design is that
this hinge may be integrated into a lamination wherein the center
of the hinge may be blocked off using a dummy up against the
sealing segments 224.
[0206] FIG. 21 is a perspective view of an example of prosthetic
socket having an adjustable hinge member with microprocessor
control. Item 250 shows where the microprocessor and control
mechanism for the ladder 252 is located within the strut member 246
along with height adjustability of the strut 244. Proximal brim
member 238 has been designed to allow for adjustability of strut
members. Item 242 is a proximal brim member designed for ischial
weight-bearing. Item 248 is an attachment and housing means for
microprocessor control adjustable member. Item 254 is an adjustment
strap member which along with adjustable member 240 provides means
for adjustment of the proximal brim circumference so that the end
user is empowered to tighten and loosen their own prosthetic socket
manually.
[0207] FIG. 22 is a perspective view of an example of a portion of
a prosthetic socket having an adjustable member with microprocessor
control. This figure shows an alternative control method for a
microprocessor hinge 262 as compared with the microprocessor
controlled hinge of FIG. 21. This control method uses a hydraulic
or pneumatic piston 266 that attaches to the strut at axis 268 in
order to move the angle of the strut 260 to a desired position.
Item 264 is a housing mechanism for the microprocessor and location
of attachment to the distal member/s of a modular prosthetic
socket. Item 260 is an adjustable height mechanism. Item 258 is a
recessed portion of the strut to accommodate an encircling ring
256.
[0208] FIG. 23 is a perspective view of an example of a prosthetic
socket having oval shaped struts 270 that extend past the socket
and form a congruent pylon and foot system, representing an entire
prosthesis. Item 270 is a strut that serves as a strut for the
socket as well as continuing down to form the keel of the foot
thereby serving as an alignment component and terminal device a
congruent unit that is also form contoured to match the needs of
the amputee.
[0209] FIG. 24 is the same illustration as FIG. 23, except that it
shows the option of having additional adjustment capabilities
incorporated into the struts 278 and the interface members 272,
276, and 288. More or less adjustability may be required, depending
on the amount of volume fluctuation the individual typically
experiences. Item 278 is a strut member with integrated
adjustability. Item 286 is a height adjustability segment. Items
284, 280, and 282 show how the strut members may be contoured to
transition directly into a prosthetic foot, to improve energy
transfer and efficiency. Item 276 is an interfacing surface pad
attached to the inside surface of the strut 278. Item 288 is a
distal cup. Item 272 is an interface pad specially designed for the
patellar tendon area of the socket. Item 274 is a proximal brim
member for the medial aspect of the socket.
[0210] FIG. 25 depicts an embodiment similar to that in FIG. 23,
except that it demonstrates with an outline that there is the
option of having the entire modular prosthesis covered with a
cosmetic covering or fairing 288. Such a cosmetic cover or fairing
288 may be made of various types of materials and may achieve
various objectives, such as protecting the inner parts or simply
providing a stylish aesthetic. The cover or fairing 288 may be made
as a custom or prefabricated addition.
[0211] FIG. 26 is a perspective view of a prefabricated wrap-around
cosmetic cover 290. This example may be made of a thin, light,
water resistant, and low-cost material such as polyethylene, and
may easily be wrapped around, trimmed, and fixed to the finished
prosthesis.
[0212] FIG. 27 is a perspective view of oval shaped struts 294 and
300, Y connecting joint member 298, proximal brim member 292, and
proximal brim connector 296. These members make up a hypothetical
example of modular members that may be selected and utilized for
the lateral-proximal aspect of a trans-tibial prosthesis.
[0213] FIG. 28 is a perspective drawing of an oval shaped strut
member. Item 306 is the convex surface, designed for comfortable
weight distribution, showing the rounded ends 308 that avoid any
sharp edges. Item 302 is a hollow, solid, or filled core, depending
on the needs.
[0214] FIG. 29 is a perspective drawing of an oval shaped strut
member 304 with contour and transverse plane rotation 304.
Adjustability may come from the material used and/or from the
mechanical design, and may remain flexible or be set rigid.
[0215] FIG. 30 is a lateral perspective of an oval shaped strut
member 304 with contour and with adjustable interface member 310.
Item 314 is an example of a set screw that may be used to tighten
or loosen the compression of the interface member 310. Access 312
to the set screws 314 allows for easy adjustment by the user or the
practitioner. A modular and adjustable interface member such as
this may be applied to different members of the socket and may be
utilized in various types of modular method sockets, as well as in
other applications previously mentioned, such as orthotics,
robotics, and exoskeletal applications.
[0216] FIG. 31 is a flow chart showing an example of the steps
involved in providing a prosthetic limb for an individual by the
method for fitting a modular prosthetic socket according to the
present invention. In step 1 of this example, an evaluation of the
individual with amputation is preformed wherein the evaluation
includes questions and assessment that lead one trained in the
field to be able to determine the activity level as well as gather
the typical and desired acts of daily living for the individual
with amputation. This information is important in ensuring that the
modular prosthetic socket will be assembled with components that
reflect the activity level of the individual and will facilitate
the specific tasks and activities the individual performs or aims
to perform. Step 2 includes weighing the individual and measuring
the dimensions and shape of the individual's residual limb in
select positions within the limb's range of motion. Step 2 is
preformed in order to establish the size and contours of the
residual limb through different positions in the limb's range of
motion. The individual is weighted because it is important that the
selected modular socket members are weight rated high enough for
the individual's weight and activity level. Other evaluation
parameters include; manual muscle testing, range of motion, skin
condition, health history, allergies, sensitive areas or aspects to
the residual limb, expectations and concerns, cosmetic preferences,
therapy history and plan, psychological wellbeing, living
condition, and other appropriate evaluation parameters. In step 3
socket members are selected from modular component inventories for
their appropriateness with respect to the evaluation, measurements,
and observation preformed in steps 1 and 2 wherein the component
inventories are inventories that are separated by level of
amputation and may include variation with respect to length, width,
contour, flexibility, elastic modulus, durometer, formability,
re-formability, adjustability, and other variation. For example,
when fitting an individual who has had a trans-radial amputation
one would refer to a modular prosthetic component kit that is
specific to trans-radial level amputation wherein the kit includes
struts of various width and weight ratings as determined by their
strength, distal cups of various diameter, and various proximal
brim styles. In step 4 the modular members that have been selected
for the individual are to be assembled in such a way that is
reflective of what has been learned of the individual during
evaluation steps 1 and 2. For example, two different individuals
may be indicated for the same modular prosthetic socket components
but require different assembly of those components that is
indicative of differences in their limb contour such that one
individual's limb contours more gradually and the other's is more
abrupt. In step 5 the socket is socket is connected to distal
components of the prosthesis. This step would be eliminated in
versions of the present invention where the distal components are
integrated into the same cohesive unit as the modular socket
members as shown in FIGS. 23-25. In step 6 the assembled modular
prosthetic socket are tried directly onto the residual limb as a
`test` fitting wherein this is considered a `test` in that it is
expected that adjustments and changes will likely be required to
optimize the fit and biomechanical control for the individual. The
`test` fitting of step 6 may be a static fitting (without motion of
the limb) or a dynamic fitting (where the limb is tested in motion
as well as static) depending on how good the test fit is and the
capabilities of the individual with the test fit socket. In step 7
the limb is protected with a thermal barrier. This step is
applicable when a direct forming technique that is exothermic or
thermoforming is to be utilized to direct mold the socket members
over the individual's residual limb in steps to follow. A thermal
barrier may be used as a precautionary measure even though
materials may even be safe directly against the skin during
thermoforming. In step 8 one or more of the members included in the
modular prosthetic socket are direct formed over the residual limb
of the individual wherein the direct fitting process may include
positive pressure or negative pressure from one or more molding aid
devices, use of a specialized jig, computer aided, other assistive
devices, and/or from manually forming member/s to the individuals
residual limb by hand. For example, a wrap-around and sealing
suction molding member may be used that can wrap around and seal
for a large variety of individuals and is transparent such that one
trained in the field can still manually influence the shape of the
molding by hand over the molding member. In step 9 the modular
prosthetic socket is donned and used dynamically while further
evaluation is used to determine any changes that are required to
the modular prosthetic socket or to the prosthesis as a whole.
Evaluation of the fit and function of the prosthesis can be done
manually through methods in the field and/or with the aid of
computer analysis which may include temporarily inserted force
sensors in the socket or permanently integrated force sensors. Step
10 represents the start of ensuring that the individual is trained
in care of the prosthesis, proper use of the prosthesis, and
necessary follow-up for the prosthesis. This training may include
referrals or internal cooperation with other healthcare
professionals such as physical and occupational therapists to aid
in training and rehabilitation for the individual.
[0217] The above description is included to illustrate the
operation of preferred embodiments, and is not meant to limit the
scope of the invention. The scope of the invention is limited only
by the following claims. From the above discussion, many variations
will be apparent to one skilled in the art that would yet be
encompassed by the spirit and scope of the present invention.
* * * * *