U.S. patent application number 17/410121 was filed with the patent office on 2022-03-03 for method of fitting a prosthetic interface system using compliant members.
The applicant listed for this patent is James Jay Martin. Invention is credited to James Jay Martin.
Application Number | 20220062014 17/410121 |
Document ID | / |
Family ID | 1000005960294 |
Filed Date | 2022-03-03 |
United States Patent
Application |
20220062014 |
Kind Code |
A1 |
Martin; James Jay |
March 3, 2022 |
METHOD OF FITTING A PROSTHETIC INTERFACE SYSTEM USING COMPLIANT
MEMBERS
Abstract
A prosthetic or orthotic device using at least one of
measurements of residual limb length or circumference to define a
prosthetic socket assembly configuration, comprising modular socket
components fitted to the individual user's residual limb having a
mounting point for an attachment, at least one compliant member
attached to at least one stabilizing unit, and at least one second
compliant member attached to at least one stabilizing unit wherein
the first compliant member and the second compliant member work in
cooperation with the stabilizing unit(s) to control bone position
and support the limb within the interface.
Inventors: |
Martin; James Jay; (Oklahoma
City, OK) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Martin; James Jay |
Oklahoma City |
OK |
US |
|
|
Family ID: |
1000005960294 |
Appl. No.: |
17/410121 |
Filed: |
August 24, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16774924 |
Jan 28, 2020 |
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17410121 |
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15886419 |
Feb 1, 2018 |
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16774924 |
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15436961 |
Feb 20, 2017 |
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15886419 |
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15260936 |
Sep 9, 2016 |
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15436961 |
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14708274 |
May 10, 2015 |
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15260936 |
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62499709 |
Feb 2, 2017 |
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61998569 |
Jul 1, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2002/7862 20130101;
A61F 2002/5024 20130101; A61F 2/76 20130101; A61F 2/78 20130101;
A61F 2002/543 20130101; A61F 2002/5027 20130101; A61F 2002/608
20130101; A61F 2/80 20130101; A61F 2/7812 20130101; A61F 2002/546
20130101 |
International
Class: |
A61F 2/80 20060101
A61F002/80; A61F 2/78 20060101 A61F002/78 |
Claims
1. A transfemoral level prosthetic socket apparatus for attaching a
prosthetic to a limb of a user comprising: a first stabilizer unit
having a first proximal end and a first distal end first end and
adapted to be perpendicularly positioned near an adductor muscle
group of said user; a second stabilizer unit having a second
proximal end and a second distal end and adapted to be
perpendicularly positioned between a hamstring and a lateral
quadriceps of said user; a proximal brim made of a complaint
material spanning from said first proximal end of said first
stabilizer to said second proximal end of said second stabilizer
and adapted to support said limb; a first adjustable member having
a length located opposite of said proximal brim and spanning from
said first proximal end of said first stabilizer to said second
proximal end of said second stabilizer wherein said length is
adjustable; a floating member having a third proximal end and a
third distal end perpendicularly positioned between said first
stabilizer and said second stabilizer opposite and below said
proximal brim and adapted capture and control said limb within said
socket; and a second adjustable member having a first end attached
to said first stabilizer, a second end attached to said second
stabilizer, and a length attached to said floating member wherein
said second adjustable member is adapted to be adjustable in
length.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation of U.S. Ser. No.
16/774,924, filed on Jan. 28, 2020, currently pending, which is a
continuation of U.S. patent application Ser. No. 15/886,419, filed
on Feb. 1, 2018, now abandoned, which claims priority to U.S.
Provisional Patent Application Ser. No. 62/499,709 filed Feb. 2,
2017, now expired and which said U.S. patent application Ser. No.
15/886,419 is also a continuation-in-part of U.S. patent
application Ser. No. 15/436,961 filed Feb. 20, 2017, now abandoned,
which is a continuation of U.S. patent application Ser. No.
15/260,936, filed Sep. 9, 2016, now abandoned, which is a
continuation-in-part of U.S. patent application Ser. No.
14/708,274, filed May 10, 2015, now abandoned, which claims
priority to U.S. Provisional Patent Application Ser. No. 61/998,569
filed Jul. 1, 2014, now expired. Each of the applications listed
above is expressly incorporated herein by reference in their
entirety.
BACKGROUND OF THE INVENTION
1. Field of the Invention
[0002] The present invention relates generally to a limb prosthesis
or orthosis for amputees or orthotic users. More particularly, the
present invention is a new and improved method for fitting a
prosthetic socket or orthotic apparatus and system utilizing simple
limb measurements to yield a defined assembly and fitting
configuration.
2. Background of the Invention
[0003] It is estimated that by the year 2050, the number of
amputees will double to over 3.6 Million. American population
health concerns are strongly correlated to the weight and age of
the individual. The American population and its health patterns
show an increase in all high-risk areas as related to dysvascular
disease, a leading cause of both stroke and amputation. In the
United States, 97% of dysvascular related amputations involve the
lower limb.
[0004] The aging baby-boomer population is just entering the age
where vascular insufficiencies tend to drastically increase, thus,
a large influx of stroke patients and amputee patients will be
entering the U.S. market alone in the coming few years.
[0005] Likewise, there exist over 30,000,000 amputees in developing
nations, where less than 5% will have access to well-fitting
prosthetics in their lifetime. Three main causes of such a
dramatically underserved amputee population in developing nations
are A. conventional prosthetics are relatively expensive to
fabricate and fit, B. there is a lack of expensive equipment needed
to fabricate conventional prosthetics, and C. there is a lack of
trained and skilled practitioners who are able to fit them.
[0006] The prosthetics market has advanced significantly in recent
years--now utilizing many new advanced components such as computer
controlled knees and feet. However, the socket interfaces are
minimally different from what was being used 20 to 30 years ago. In
fact, many of the socket interfaces that are still considered
state-of-the-art were originally developed between the 1960's and
1990's, with only minor advancements in materials and suspension
methods since then. The core socket interface designs have gone
largely unchanged.
[0007] There are numerous prosthetic and orthotic companies that
provide components for conventional interface designs--ranging from
various embodiments of gel liners and suspension aids for
prosthetics users. In each of these, the core interface approaches
used are antiquated and in desperate need of more advanced methods
of how to fit prosthetic devices.
[0008] The current state-of-the-art fails to truly accommodate for
limb volume changes, has narrow transitions from high force to no
force resulting in rubbing and discomfort, and creates a volatile
skin environment that is hot and sweaty.
[0009] Conventional transfemoral socket shapes hydrostatically
compress the residual limb and its tissues into a tight-fitting
pre-determined bucket shape, often referred to as a "socket". The
lineage of transfemoral design typically include compressing the
soft tissue around the underlying muscle-channels and locking
around the tuberosity/ramus in various orientations. Conventional
socket shapes remain static in size and shape. As the human limb
changes in shape and volume, the "key in a keyhole" fit is
lost.
[0010] The tight fitting nature of conventional interfaces leads to
rubbing at the trim lines. At this level, the tissue compression
goes from high force to no force over a narrow band, resulting in
shear forces on the fragile tissue. The use of rigid or semi-rigid
materials in conventional socket interfaces compounds this problem.
There is a need for softer, more dynamic materials to be used at
transition areas, allowing for compliant transition zones.
[0011] The hostile interface environment of conventional
prosthetics is hot, full of constant perspiration, lack
breathability, and are heavy. As such, many users suffer from
various skin conditions including: skin breakdown, pressure sores,
heat rash, abrasions, chaffing, dryness, folliculitis, dermatitis,
ulcers, eczema, psoriasis, and dry skin. Prosthetics users are
desperately searching for better solutions to the many outstanding
problems associated with conventional socket interfaces.
[0012] The socket interface is by far the most important component
of a successful prosthetic or orthotic device. While advanced
computer controlled joints are incredibly beneficial for enhancing
functional performance, if the socket interface is not stable and
comfortable, the high-tech components have little advantage.
[0013] Orthotics and prosthetics users are desperately searching
for better solutions to the many outstanding problems associated
with conventional socket interfaces. Much of the work in advancing
the socket comfort has been focused around new materials and
suspension capabilities of gel liners, and lighter weight carbon
fiber materials. However, the inherent socket interface designs
themselves have seen very little change in how they are fit to the
patient.
[0014] For prosthetics users, the gel liners are a soft padding
that resides between the users' limb and the hard socket interface.
While these do provide more cushion, they do not address volume
change issues, and tend to be very hot, full of perspiration, and
make for a hostile environment for the skin. The application of a
more advanced compliant-based socket interface approach will
greatly enhance the functionality and the daily living for the end
user.
[0015] Weight Reduction
[0016] Prosthetics devices are a significant weight hanging off the
body. The Compliant Force Distribution socket interface designs, as
disclosed herein, may use compliant materials within its surface
area, versus thermoplastic and carbon fiber rigid encapsulated
sockets, which are inherently heavier. Thus, the compliant-based
socket design may offer a reduction in weight of over 50%.
[0017] Keeping the actual weight of prosthetic devices as low as
possible is critically important for the efficiency and comfort of
the user, but just as important is the perceived weight. The more
intrinsic bone motion within the residual limb due to soft tissue
pliability in a conventional hydrostatic socket fit results in a
significant loss of biomechanical efficiency, and an increase in
the perceived weight of the device.
[0018] The dynamic Compliant Force Distribution socket interface
designs provide for an inherently greater biomechanical lock around
the underlying bony structure, providing for a greater one to one
connectivity between the user's body and the device--further
decreasing perceived weight.
[0019] Point Pressures and Force Distribution
[0020] One of the main areas causing abrasions within a
conventional prosthetic or orthotic socket interface is the trim
lines. The trim lines are where there is a rapid transition from
high pressure to no pressure. Because the conventional socket
interface does not change in shape with the dynamic underlying
body, the user's skin often rubs at the trim lines, causing
abrasions. Conventionally used padded straps for instance are
around 1''-2'' wide and are typically pulled tight to provide for
stability. The skin under the straps is highly compressed, and the
skin just outside of the straps is not. This narrow area of high
force to no force creates a shear point. The same issue is found at
trim lines of the socket.
[0021] The compliant socket designs however eliminate the
conventional trim-line transitions, and are replaced with a broad
compliant fabric, allowing for a significantly broader distribution
of pressures, and a very gradual transition from high forces to no
forces.
[0022] No matter how much "padding" is used with conventional
straps or trimlines, the forces remain distributed within a small
surface area. Compliant Force Distribution provides a more gradual
transition of forces at the edges, and equalizes the amount of
force per square inch within the load bearing areas.
[0023] Sensor Integration
[0024] The Compliant Force Distribution socket interface technology
has been successfully applied to high-level upper extremity
amputees. In conventional upper extremity socket designs, the
electrodes tend to gap away from the body, as they would typically
be integrated into a rigid or semi-rigid socket over a dynamic
body. Compliant Force Distribution interface techniques instead
maintain consistent electrode contact, as the sensors are
"hammocked" directly to the user's limbs, with no loss of
connection.
[0025] The future of socket designs for other levels of amputation,
as well as for some orthotics users will incorporate various
sensors, including myoelectric electrodes. Other than the Compliant
Force Distribution Technology, there is not an elegant method of
incorporating sensors and wires within a socket interface
environment. These designs solve the outstanding issues that
prevent the practical use of sensors and electrodes within the
socket, as they are akin to a hammock and inherently hold the
interface tightly against the users' limb--maintaining consistent
contact.
[0026] Skin Environment
[0027] Conventional interface designs encompass the user's limb,
creating a hot, moist environment that leads to a variety of skin
issues including pressure sores, heat rash, abrasions, chaffing,
dryness, folliculitis, dermatitis, ulcers, eczema, psoriasis,
dryness, and skin breakdown.
[0028] The human skin is designed to breath. By design, the human
skin perspires to cool itself, but instead, any perspiration within
a conventional socket is trapped and a prosthetics user for
instance typically can pour sweat out of their socket upon taking
it off.
[0029] The Compliant Force Distribution interface designs however
may be breathable, and allow for perspiration to escape, and the
limb to remain cool, naturally.
[0030] Control and Stability
[0031] In transfemoral amputations for instance, the cut femur bone
is no longer directly connected to the remaining leg. With a
conventional hydrostatic socket design, the cut femur bone moves
back and forth within the soft tissue of the residual limb,
decreasing ambulation efficiency.
[0032] Randy Alley recently created the Hi-Fidelity socket to
better lock the residual bone in a consistent position within the
socket (U.S. Pat. No. 8,323,353). His work with the Hi-Fi
demonstrates the ability to alter the biomechanical synchronization
between the residual bone and prosthesis by changing how the socket
interface is fit to the user.
[0033] Likewise, the Compliant Force Distribution design is able to
replicate the lost biomechanical and neuromuscular connection
between the limb and the user by better controlling underlying bone
position within the socket, though through a radically different
method. Just as importantly, it does so in a modular, breathable
way that also accommodates for volume changes. Unlike Randy Alley's
socket design, this approach captures the underlying bony structure
in a much less aggressive and more compliant manner, making it
easier to achieve more comfort. Instead of using aggressive
compression zones that encircle the limb, this design more
elegantly captures the contouring of the underlying anatomy to lock
the bony structure in a desired orientation with respect to the
prosthesis.
[0034] By more elegantly spreading the load over a broad surface
area, our technology is not only reducing the amount of force per
square inch, but more importantly, is providing a much more secure
connectivity between the user and the device. A prosthetic or
orthotic device is a mechanical or electro-mechanical extension
from the body. Every amputee for instance gains what is called
external physiological proprioception. This means that they are
able to at least partially gain a proprioceptive sense of where the
prosthesis is in space, in relation to their body. When they move
their leg forward to take a step, they have a sense of where their
leg position is in space, even though their prosthesis is not
neurally connected to their brain. However, the more "wiggle room"
there is between their residual limb skeletal system and the
prosthesis, the less specificity they have of a true proprioceptive
sense of their leg position.
[0035] For transfemoral amputees for instance, the femur bone
section is cut at the amputation level and is no longer directly
connected to the remaining leg. With a conventional hydrostatic
socket design, when the transfemoral amputee kicks their leg
forward to initiate the swing phase of gait, their femur bone moves
back and forth within the soft tissue of their residual limb, and
they lose much of the true proprioceptive sense of leg
position.
[0036] Volume Accommodating--Dynamic vs. Static
[0037] The human body is dynamic--yet the socket interfaces we use
today are largely relatively static in their size and shape. Socket
interfaces typically use a rigid or semi-rigid carbon fiber shell
surrounding a semi-flexible thermoplastic inner layer. While this
inner layer has some flexibility, its size and shape remain static,
and cannot accommodate weight gain or loss. This leads to
discomfort and degradation in functional performance of the user if
their body changes in size and shape, and no longer perfectly
matches the socket interface. Just a small body weight change of 5
lbs. can significantly affect the socket interface fit. It is like
wearing a shoe that is a couple sizes too big or too small--except
that the effect is greatly compounded, as the limbs are not
designed to bear the incredible ambulation forces, as the foot is
designed to do.
[0038] The human body gains and loses volume due to hydration
levels, foods we eat (for instance salty foods versus non-salty
foods), exercise, or lack thereof, eating habits, age related
issues, and other diseases like diabetes and dysvascular
disease.
[0039] If the socket does not perfectly fit, it leads to abrasions,
rubbing, pressure on the cut end of the amputated bones, unwanted
pressure on sensitive nerves, and overall discomfort. Most amputees
and orthotics users experience socket interface discomfort from
time to time. Socket interfaces tend to need to be replaced every 1
to 3 years due to body size and shape changes.
[0040] The Compliant Force Distribution technology inherently
accommodates for size and shape changes in the user. These socket
interface designs are compliant-based, versus a rigid or semi-rigid
shape, therefore the socket interface can be quickly and easily
user-adjusted in its tightness to provide a comfortable fit
independent of weight gain or loss. As has been found with the
Shoulder Disarticulation version of the Compliant Force
Distribution socket interface design, the amputee is able to
quickly and easily adjust the fit of their prosthetic device to
ensure the most comfortable fit.
[0041] Conventional prosthetic socket designs could be more closely
compared to wooden clog shoes, in that their size and shape do not
adequately accommodate for the dynamic nature of the human body.
Even if the wooden clog were to be perfectly contoured to the
user's foot, its comfort would be limited, especially when the size
and shape of the dynamic foot were to change. A compliant-based
socket design would more closely resemble the VIBRAM five-fingered
shoes, in that they are made of a soft dynamic material that
perfectly contours to the user's foot, versus the foot matching to
the shoe.
[0042] Fitting Method.
[0043] Conventional socket fitting methods typically require
capturing an impression of the limb shape, modifying that
impression shape, and iterating through test sockets before a final
fitting shape is defined and completed. Capturing the impression
shape is largely accomplished by hand casting, or scanning. The
cast is then either by hand or electronically modified in shape to
achieve a positive model of the socket shape, to then pull a
thermoplastic inner socket over be used in diagnostic evaluation of
the fitting on the actual limb. This process is time consuming,
inexact, and inefficient.
3. Description of the Known Prior Art
[0044] Conventionally used prosthetic interfaces remain as an
anatomically contoured socket in which the residual limb fits
within. This socket may be specifically tailored to the residual
limb's size and shape, but it largely remains as a static size and
shape. While some flexible materials may be incorporated, their
flexibility is typically no more than minor amounts of give at
their edges, and not true accommodation for the dynamic nature of
the underlying body in which they are fit.
[0045] In recent years there have been a few attempts at improving
lower extremity socket interface design, and overcome some of the
outstanding issues surrounding them.
[0046] One such attempt developed by Randy Alley through the
Hi-Fidelity (Hi-Fi) Interface (U.S. Pat. No. 8,323,353) design
offers excellent locking around the underlying skeletal system,
versus solely hydrostatic tissue loading as with conventional
designs. However, the Hi-Fi system currently requires full
customization for each user, and currently does not accommodate
volume changes of the user any more so than other conventional
transfemoral designs. It also uses an enclosed socket cavity in
which the limb is fit, which does not fully address the
environmental issues of limb encapsulation. While this design could
in theory be transitioned to more of a modular approach, its design
by nature would still require significant customization of the
various components to fit appropriately to the user.
[0047] The Alley design requires a common distal connection point
for each of the four vertical struts. The common distal connection
point holds the vertical struts in a certain orientation about the
limb for a transfemoral amputee, resulting in a locked-in socket
shape. While the distal common connection point could become
modular, once fit to the user, the position of the vertical struts
is maintained in a consistent position, and is not quickly or
easily adjustable for the patient.
[0048] It is important to offer a prosthetic interface design that
is modularly adjustable by the end user, in real-time, so that they
can match the socket to their limb, versus their limb having to
match to the socket. In the Alley design, plastic shims may be used
to adjust the static socket shape to the user, by placing them in
between the static socket shape and the user's limb to take up
space. In this invention however, our design can be modularly
adjusted on the fly, allowing an end user to quickly and easily
tighten or loosen to socket fit to match their desired comfort.
[0049] The Alley design uses struts that extend from the common
distal connection point to the proximal brim of the socket. Our
design instead uses floating force distribution anchors, to capture
the long bone and conform it to the medial wall of the interface
design. By using a floating design, the socket interface fully
matches to the shape and size of the underlying limb with real-time
adjustability, versus requiring a limb to match the shape of a
customized socket fit to the patient, as in the Alley design.
[0050] Additionally, the Alley design uses the vertical struts as
the structural element of the socket, and does not include any
compliant members in the design. In our design, we instead make the
force distribution anchors as floating, and not connected as a
vertical structural element of the socket, in order to be compliant
to match the compliant body, and then can integrated flexible
fabric or flexible materials or adjustable connectors to span as
the connectors. By doing such, this design can effectively leverage
the long bone of the limb to become a structural element of the
socket, versus solely relying on the carbon fiber struts to be the
structural part of the design. Since this design captures the long
bone with floating force distribution anchors, and manages the bone
position to the stabilizing anchor, the long bone is controlled and
its lock within the system assists in creating a structural element
of system support.
[0051] The Alley design locks the long bone in a set position from
all sides, as the vertical struts compress into the soft tissue
circumferentially around the limb. This design instead pulls the
long bone over to the stabilizing anchor, generating a more
appropriate and controlled femoral angle.
[0052] According to the Alley patent, their design uses a limb
encapsulated strut design where the struts are "appropriately
contoured to a patient's residual limb" and "contains windows
through which soft tissue can flow". Our design instead is able to
use force distribution anchors that can either be of an
off-the-shelf shape, or can be dynamic in nature, not fully
maintaining any particular shape, but rather match to the shape of
the limb. In addition, our design does not have windows which the
soft tissue can flow, but rather has un-encapsulated areas where
there is not structure, and hence no windows.
[0053] Still further, Alley's design requires areas of specific
isolated compression zones, whereas our disclosure provides broader
areas of tissue stabilization, spreading the forces across more
surface area than just isolated struts, and instead may utilize a
combination of struts and compliant materials together to broaden
the load bearing areas. In Alley's design, tissue is compressed
such that the bone is locked in a position from all sides, due to
the isolated tissue compression. Our design rather uses purposeful
contouring around the bone such that a broader area of the limb is
captured and controlled, and pulled toward the main anchor
stabilizer along the medial aspect of the interface. Alley's design
further calls for areas of the interface to be "enclosed or
completely open provided there is minimal restriction to soft
tissue flow". Our design instead benefits from open areas where the
soft tissue may be further controlled with compliant means, versus
just relying on it to flow freely with minimal restriction.
[0054] Even further, Alley's patent calls for no less than 3
compression portions, while our approach utilizes just 2
pseudo-compression portions, where compliant means may be spanned
in between. Our main anchor stabilizer may be sufficient in
dimensions to not necessarily cause its own tissue compression in
the same manner as other narrower struts would, as in Alley's
design.
[0055] Still further, Alley's patent also calls for the struts to
be of similar length as the long bone. In our design, the length
may be modularly adjustable, and does not necessarily need to
extend to the furthest distal end, or furthest proximal end, as our
force distribution stabilizers are not directly connected to a
common distal mounting point or proximal brim as in Alley's
designs.
[0056] More recently Hurley's (LIM Innovations) (patent application
number 2014/0135946 A1) introduced a modular version of Alley's
Hi-Fi socket. Hurley's design accomplishes much the same as what
was described by Alley, and functionally is equivalent how it fits
to a residual limb, with the exception of being modular. Similar to
Alley's design, the Hurley design requires significant
customization, and a complex and time consuming fabrication and
assembly process, and encapsulates the limb in a structure that
surrounds the limb as a solid structural unit. While Hurley's
design is modular in nature, the modularity of the design is suited
well for a practitioner to modify it to a patient, but is not
conducive for a patient to modify it on the fly in real-time.
Hurley's design as well locks the long bone in a set position from
all sides, as the vertical struts compress into the soft tissue
circumferentially around the limb. The Hurley design shares most of
the same disadvantages as Alley's design, as was discussed above,
as they effectively have the same functions in how they fit about
the underlying limb.
[0057] The recent REVOLIMB design uses an adjustable Boa lacing
system to slightly tighten or loosen various pads within the
socket. This provides a step toward making a more accommodating
socket though it still remains as a fully encapsulated limb
environment, is complex to fabricate, requires significant
customization, and is limited in its volume accommodation.
[0058] Cornell (U.S. Pat. No. 8,945,237) disclosed a transfemoral
socket using a fabric spanned across one side of the frame,
referred to as a sail. His disclosure spans the limb
circumferentially, but fails to capture or manage the long bone. In
his sail design, the limb is simply encapsulated with a combination
of rigid frame, and flexible fabric, though the entire limb is
encapsulated circumferentially giving a similar socket shape and
effects as conventional socket designs. The main advantage that his
sail material is that it provides more flexibility in sitting, and
is adjustable. However, by not controlling the bone position within
the socket, it fails to influence the biomechanical efficiencies
while walking.
[0059] Meanwhile, Cornell's disclosure also calls for the remainder
of the limb, which is not supported by the rigid support to be
supported by the fabric sail support, to create a hydrostatic
weight bearing support of the entire limb and its tissue.
Conversely, in our disclosure, we may purposely maintain open areas
to allow the tissue to expand out as needed, so that we can
compress the medial/lateral dimension, drawing the long bone into
proximity with the anchor stabilizer.
[0060] The notion of using a rigid J-shaped support, as Cornell
discloses, has been used in the prosthetics field for many years.
Between 1999 and 2006 various tests were conducted at Sabolich
Prosthetics to cut down the frame's trimlines to more a micro-frame
design, resembling the Hi-Fi socket in look, though not necessarily
fully in function with aggressive compression zones in the same way
as Alley has demonstrated. These clinical fitting experiments, as
well as the Hi-Fi sockets design, have demonstrated that the force
coupling within a transfemoral socket can be achieved through a
micro-frame structure, versus a fully encapsulated frame. Various
tests were conducted using a J-shaped main frame, with a compliant
silicon material encircling the limb that would be connected to the
J-shaped frame. We found that the limb was able to remain stable in
such a setup. Distal cups trimmed out at the distal end of the
socket, and J shaped trimlines have been common in various socket
shapes for many years (Schuch, Michael, Transfemoral Amputation:
Prosthetic Management, Atlas of Limb Prosthetics 20B).
[0061] Other prosthetic component manufacturers provide components,
such as gel liners, for use in conventional sockets, which do not
significantly depart from conventional socket design. The Ossur
Seal-In V liner for instance is a flexible thermoplastic/silicon
sock that rolls over the amputee's residual limb, which then fits
into the conventional socket. The sealing rings of this design
offer a better method of suspending the prosthesis than predecessor
designs, by forming a suction sealing effect toward the distal end
of the socket. While the liner does provide cushion for the user,
and the suspension capabilities of this design work very well, it
is but an iteration of conventional socket approaches, and fails to
truly accommodate for volume changes in the residual limb.
[0062] Additionally, unlike Alley, Cornell, or Hurley's disclosure,
our design does not require a proximal brim as is commonly used.
Unlike any other interface design, we can effectively have a
brimless socket interface, since this design is the only one, which
does not truly encapsulate the limb with a structure about the
circumference of the entire limb. Instead, this disclosure may have
floating elements, which may be modularly and adjustably tightened
against the limb.
[0063] Still further, the other socket designs including Alley,
Hurley, and Cornell, all utilize distal contouring of the limb
within the socket, and as such bear a portion of the weight
distally. Likewise, any weight bearing that is bore
circumferentially around the limb extends directly to the distal
attachment area. This invention however may utilize a
non-weight-bearing distal end, and any force through the body of
the limb may be bore through the stabilizing unit alone to the
distal attachment area. By doing such, the size of the interface
can be modularly adjusted circumferentially in real-time by the end
user.
[0064] Any contouring of the interface about the distal end of the
limb may come through compliant materials, versus rigid structure,
as used by Alley, Hurley, and Cornell. The distal end of this
invention may use more of a hammock-type fit with the contouring of
the distal end to be modularly adjusted to the user, through
compliant materials that match to the user, versus the user having
to match to a pre-formed shape on the distal end of a conventional
socket. Spanning fabric to create a distal end, if one is used,
ensures comfort, and that there is not too much force applied in
that area.
[0065] An open distal end, or a modularly adjustable distal end
through compliant materials allows for open wounds on the distal
end of the limb to be un-enclosed, and to promote healing. As such,
this invention could be applied to a new amputee, quickly after the
amputation, or to a user who needs to have their distal end
de-weighted for healing purposes. An open air design makes for the
skin environment to be significantly healthier, versus the
conventional hostile interface environment of conventional sockets
that encapsulate the limb in a hot, moist environment.
[0066] Even if weight is applied to the distal end of this
invention, it is estimated that a relatively small amount may be in
contact there, with a predominant amount, likely above 90% to be
applied through the stabilizing unit, and its opposing force
coupling means.
[0067] Likewise, this invention could be applied in developing
nations, where there is a need for a modular prosthetic design that
would not require time consuming an expensive custom fabrication
processes, materials, and equipment. Through using off-the-shelf
modular kit components, prosthetics can now be fit, either locally
or in developing nations, inexpensively. And, since this invention
offers so much modularity to fit various users, and fit with them
with increased comfort and control, the end user's life is
enhanced. Each of the elements of this disclosure can be offered in
a kit set, including the connectors, stabilizing unit and force
distribution anchors, etc., to allow for quick and accurate fitting
of prosthetics.
[0068] In each of the above prior art, conventional casting,
modification, and iterative fitting evaluations are required.
SUMMARY OF THE INVENTION
[0069] The present invention relates generally to a new and
improved prosthetic interface design, and method of producing. In
particular, the present invention is a new and improved method of
providing control and comfort within a prosthetic device in a more
efficient and effective manner.
[0070] In this respect, before explaining at least one embodiment
of the invention in detail, it is to be understood that the
invention is not limited in this application to the details of
construction and to the arrangement of the components set forth in
the following description or illustrated in the drawings. The
invention is capable of other embodiments and of being practiced
and carried out in various ways. Also, it is to be understood that
the phraseology and terminology employed herein are for the purpose
of description and should not be regarded as limiting. As such,
those skilled in the art will appreciate that the conception, upon
which this disclosure is based, may readily be utilized as a basis
for the designing of other structures, methods, and systems for
carrying out the several purposes of the present invention. It is
important, therefore that the claims be regarded as including such
equivalent constructions insofar as they do not depart from the
spirit and scope of the present invention.
[0071] Accordingly, titles, headings, chapters name,
classifications, and overall segmentation of the application in
general should not be construed as limiting. Such are provided for
overall readability and not necessarily as literally defining text
or material associated therewith.
[0072] Further, the purpose of the foregoing abstract is to enable
the U.S. Patent and Trademark Office and the public generally, and
especially the scientist, engineers and practitioners in the art
who are not familiar with patent or legal terms or phraseology, to
determine quickly from a cursory inspection the nature and essence
of the technical disclosure of the application. The abstract is
neither intended to define the invention of the application, which
is measured by the claims, nor is it intended to be limiting as to
the scope of the invention in any way.
[0073] It is therefore an object of the present invention to
provide a new and improved method of fitting prosthetics to those
with limb loss.
[0074] It is a further object of the present invention to provide a
prosthetic interface that is simpler and more consistent to fit to
the user.
[0075] It is a further object of the present invention to provide a
prosthetic interface whose fit is measureable, quantifiable, and
repeatable.
[0076] It is a further object of the present invention to provide a
prosthetic interface that is user adjustable.
[0077] It is a further object of the present invention to provide a
prosthetic interface that is more breathable.
[0078] It is a further object of the present invention to provide a
prosthetic interface that is lower profile under clothing. It is a
further object of the present invention to provide a prosthetic
interface that is lighter in weight.
[0079] It is a further object of the present invention to provide a
prosthetic interface that is modular and repairable.
[0080] It is a further object of the present invention to provide a
prosthetic interface that can be fabricated less expensively and
quicker.
[0081] It is a further object of the present invention to provide a
prosthetic interface that uses compliant structures versus rigid or
semi-rigid structures.
[0082] It is a further object of the present invention to provide a
prosthetic interface that truly accommodates for volume and shape
changes of the dynamic underlying body.
[0083] It is a further object of the present invention to provide a
prosthetic interface that provides gradual transitions of forces at
its trim lines.
[0084] It is a further object of the present invention to provide a
prosthetic interface that does not encapsulate the limb in the same
manner as conventional designs.
[0085] It is a further object of the present invention to provide a
prosthetic interface that captures the lost biomechanical and
neuromuscular connection between the limb and the user.
[0086] It is a further object of the present invention to provide a
prosthetic interface to better control underlying bone position
within the socket.
[0087] Another object of the present invention is to provide a new
and improved system which provides some of the advantages of the
prior art, while simultaneously overcoming some of the
disadvantages normally associated therewith.
[0088] These together with other objects of the invention, along
with the various features of novelty that characterize the
invention, are pointed out with particularity in the claims annexed
to and forming a part of this disclosure. For a better
understanding of the invention, its operating advantages, and the
specific objects attained by its uses, reference would be had to
the accompanying drawings and descriptive matter in which there are
illustrated preferred embodiments of the invention.
BRIEF DESCRIPTION OF THE PICTORIAL ILLUSTRATIONS, GRAPHS, DRAWINGS,
AND APPENDICES
[0089] The invention will be better understood and objects other
than those set forth above will become apparent when consideration
is given to the following detailed description thereof. Such
description makes reference to the annexed pictorial illustrations,
graphs, drawings, and appendices.
[0090] FIG. 1A generally illustrates an embodiment of a
transfemoral socket interface, viewed from a perspective angle.
[0091] FIG. 1B generally illustrates an embodiment of a
transfemoral socket interface, viewed from a perspective angle.
[0092] FIG. 1C generally illustrates an embodiment of a
transfemoral socket interface, viewed from a perspective angle.
[0093] FIG. 1D generally illustrates an embodiment of an attachment
means connected to an embodiment of a force distribution
stabilizer, viewed from a perspective angle.
[0094] FIG. 1E generally illustrates an embodiment of a
transfemoral socket interface, viewed from a perspective angle,
using compliant force distribution stabilizer structure with other
compliant material spanned there between.
[0095] FIG. 1F generally illustrates an embodiment of a
transfemoral socket interface, viewed from a perspective angle,
using a less compliant force distribution stabilizer structure with
other compliant material spanned there between.
[0096] FIG. 1G generally illustrates an embodiment of a
transfemoral socket interface, viewed from a perspective angle,
using a form holding structure spanned between force distribution
stabilizers.
[0097] FIG. 1H generally illustrates an embodiment of a
transfemoral socket interface, viewed from a perspective angle.
[0098] FIG. 1I generally represents possible cross sections of a
proximal top-down view of an embodiment of the stabilizing unit
102, as may be affixed to the medial or lateral aspect of the
transfemoral limb.
[0099] FIG. 2A generally illustrates an embodiment of a compliant
structure as may be used for the gluteal fold area.
[0100] FIG. 2B generally illustrates an embodiment of a compliant
structure as may be used for the gluteal fold area.
[0101] FIG. 3 generally illustrates another embodiment of a
transfemoral socket interface, viewed from a perspective angle.
[0102] FIG. 4A generally illustrates another embodiment of a
transfemoral socket interface, viewed from a perspective angle.
[0103] FIG. 4B generally illustrates another embodiment of a
transfemoral socket interface, viewed from a perspective angle.
[0104] FIG. 5 illustrates an embodiment of the prior art, using an
encapsulated socket interface.
[0105] FIG. 6A generally illustrates another embodiment of a
transfemoral socket interface, viewed from a perspective angle.
[0106] FIG. 6B generally illustrates a close up view of an
embodiment for a distal femoral stabilizing unit.
[0107] FIG. 7 illustrates the human anatomy and the desired femoral
angle in particular.
[0108] FIG. 8 illustrates various embodiments of prior art showing
the evolution of transfemoral socket interface designs.
[0109] FIG. 9 illustrates the human anatomy as it fits within one
embodiment of conventional prior art socket interface designs.
[0110] FIG. 10 illustrates another embodiment of a transfemoral
socket interface, viewed from the perspective angle.
[0111] FIG. 11 illustrates the benefits of distributing forces
through using compliant materials.
[0112] FIG. 12A illustrates another embodiment of an interface,
viewed from the perspective angle.
[0113] FIG. 12B illustrates another embodiment of a transfemoral
interface, viewed from the perspective angle.
[0114] FIG. 12C illustrates another embodiment of an interface,
viewed from the perspective angle, for use in upper extremity.
[0115] FIG. 12D illustrates another embodiment of a prosthetic
interface, viewed from the perspective angle.
[0116] FIG. 13 generally illustrates an embodiment of a
transfemoral socket interface, viewed from a perspective angle,
being worn by a user.
[0117] FIG. 14 generally illustrates an embodiment of a
transfemoral socket interface, viewed from a perspective angle,
being worn by a user.
[0118] FIG. 15 generally illustrates an embodiment of a
transfemoral socket interface, viewed from a perspective angle.
[0119] FIG. 16 is a perspective view of a distal attachment
embodiment.
[0120] FIG. 17 is a perspective view of an embodiment of a
prosthetic interface.
[0121] FIG. 18 is a cross section view of an embodiment of a
pad.
[0122] FIG. 19 is a cross section view of an embodiment of a
pad.
[0123] FIG. 20 is an embodiment of a surface texture on a pad.
[0124] FIG. 21 is an embodiment of a surface texture on a pad,
which may be used for suspension or control within a device.
[0125] FIG. 22 is an embodiment of an application of using such
pads within an existing socket.
[0126] FIG. 23 is a perspective view of an embodiment of the
disclosed invention in a splayed open position.
[0127] FIG. 24 is an embodiment of a connector with incremental
numbers designating its position.
[0128] FIG. 25 is an embodiment of a connector with incremental
numbers designating its position.
[0129] FIG. 26A is an embodiment of a fitting component kit that
may be used to fit and align a prosthetic socket and its anchor
struts to a user.
[0130] FIG. 26B is an embodiment of a fitting component kit that
may be used to fit and align a prosthetic socket and its anchor
struts to a user.
[0131] FIG. 27 is an embodiment of a mounting plate with infinite
adjustability in rotary position.
[0132] FIG. 28 is an embodiment of a distal mounting plate that may
be modified in its angle to connect an anchor strut to a distal
end.
[0133] FIG. 29A generally illustrates an embodiment used in a
tranhumeral application.
[0134] FIG. 29B generally illustrates an embodiment used in a
tranhumeral application.
[0135] FIG. 29C generally illustrates an embodiment used in a
tranhumeral application.
[0136] FIG. 29D generally illustrates an embodiment used in a
tranhumeral application.
[0137] FIG. 29E generally illustrates an embodiment used in a
tranhumeral application.
[0138] FIG. 30A generally illustrates an embodiment used in a
transradial application.
[0139] FIG. 30B generally illustrates an embodiment used in a
transradial application.
[0140] FIG. 30C generally illustrates an embodiment used in a
transradial application.
[0141] FIG. 30D generally illustrates an embodiment used in a
transradial application.
[0142] FIG. 30 E generally illustrates an embodiment used in a
transradial application.
[0143] FIG. 31A generally illustrates an embodiment used in a
transtibial application.
[0144] FIG. 31B generally illustrates an embodiment used in a
transtibial application.
[0145] FIG. 31C generally illustrates an embodiment used in a
transtibial application.
[0146] FIG. 31D generally illustrates an embodiment used in a
transtibial application.
[0147] FIG. 31E generally illustrates an embodiment used in a
transtibial application.
[0148] FIG. 31F generally illustrates an embodiment used in a
transtibial application.
[0149] FIG. 31G generally illustrates an embodiment used in a
transtibial application.
[0150] FIG. 32 illustrates the use of a gel liner or the like with
an embodiment of a socket interface.
[0151] FIG. 33 illustrates a schematic of a swing brim webbing and
materials for assembly.
[0152] FIG. 34A illustrates lateral, posterior, medial, and
anterior assembly of a socket less socket and swing brim around a
conventional flexible inner socket to provide additional conformity
for a user.
[0153] FIG. 34B illustrates lateral, posterior, medial, and
anterior assembly of a socket less socket and swing brim around a
conventional flexible inner socket to provide additional conformity
for a user.
[0154] FIG. 34C illustrates lateral, posterior, medial, and
anterior assembly of a socket less socket and swing brim around a
conventional flexible inner socket to provide additional conformity
for a user.
[0155] FIG. 34D illustrates lateral, posterior, medial, and
anterior assembly of a socket less socket and swing brim around a
conventional flexible inner socket to provide additional conformity
for a user.
[0156] FIG. 35A illustrates lateral, posterior, medial, and
anterior proposed trim lines of a flexible inner socket compared to
conventional socket trimlines.
[0157] FIG. 35B illustrates lateral, posterior, medial, and
anterior proposed trim lines of a flexible inner socket compared to
conventional socket trimlines.
[0158] FIG. 35C illustrates lateral, posterior, medial, and
anterior proposed trim lines of a flexible inner socket compared to
conventional socket trimlines.
[0159] FIG. 35D illustrates lateral, posterior, medial, and
anterior proposed trim lines of a flexible inner socket compared to
conventional socket trimlines.
[0160] FIG. 36A illustrates lateral, posterior, medial, and
anterior proposed trim lines of a conventional frame as trimmed
down to accommodate a swing brim.
[0161] FIG. 36B illustrates lateral, posterior, medial, and
anterior proposed trim lines of a conventional frame as trimmed
down to accommodate a swing brim.
[0162] FIG. 36C illustrates lateral, posterior, medial, and
anterior proposed trim lines of a conventional frame as trimmed
down to accommodate a swing brim.
[0163] FIG. 36D illustrates lateral, posterior, medial, and
anterior proposed trim lines of a conventional frame as trimmed
down to accommodate a swing brim.
[0164] FIG. 37A illustrates lateral, posterior, medial, and
anterior proposed assembly of a conventional socket with integrated
swing brim after trim lines of the conventional inner socket and
conventional frame to accommodate a flexible swing brim.
[0165] FIG. 37B illustrates lateral, posterior, medial, and
anterior proposed assembly of a conventional socket with integrated
swing brim after trim lines of the conventional inner socket and
conventional frame to accommodate a flexible swing brim.
[0166] FIG. 37C illustrates lateral, posterior, medial, and
anterior proposed assembly of a conventional socket with integrated
swing brim after trim lines of the conventional inner socket and
conventional frame to accommodate a flexible swing brim.
[0167] FIG. 37D illustrates lateral, posterior, medial, and
anterior proposed assembly of a conventional socket with integrated
swing brim after trim lines of the conventional inner socket and
conventional frame to accommodate a flexible swing brim.
[0168] FIG. 38 illustrates a general schematic of an embodiment of
a modular prosthetic socket in which sub-components may enable
defined configuration assembly.
[0169] FIG. 39A illustrates a possible work flow of software, which
may be used to input limb measurements and output a defined
assembly configuration.
[0170] FIG. 39B illustrates a possible work flow of software, which
may be used to input limb measurements and output a defined
assembly configuration.
[0171] FIG. 39C illustrates a possible work flow of software, which
may be used to input limb measurements and output a defined
assembly configuration.
[0172] FIG. 40A generally illustrates another preferred embodiment
in accordance with the current invention.
[0173] FIG. 40B generally illustrates another preferred embodiment
in accordance with the current invention.
[0174] FIG. 40C generally illustrates another preferred embodiment
in accordance with the current invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0175] Referring now to the drawings, wherein like reference
numerals designate corresponding structure throughout the views,
and referring in particular to FIG. 1A, numeral 100 generally
refers to a new and improved compliant based transfemoral level
prosthetic socket apparatus, assembly and/or system, hereinafter
referred to generally and collectively as invention 100.
[0176] Of note, invention 100 may be generally shown by example in
a configuration for an individual missing a right or left leg or
portion thereof at a knee disarticulation or transfemoral level. It
is understood that such configuration is for example purposes only
and that such should not be considered limiting and a left or right
side configuration is also considered. It is further understood
that invention 100 may be used where the level of amputation may
dictate a different configuration than transfemoral or knee
disarticulation level, such as but not limited to transtibial,
transradial, transhumeral, or other levels either prosthetically,
orthotically, or with exoskeletal robotics--all of which may be
considered as human/machine connectivity. The terms should not be
considered limiting the invention nor the general shape and
configuration depicted in the drawings. Invention 100 may encompass
many embodiments, as generally illustrated in the various figures,
and should not be considered limiting where any particular figure
depicts one embodiment of invention 100, as there are various
elements, embodiments, and user specific requirements.
[0177] In a preferred construction, there may be a distal
attachment area or structure 101 for mounting other prosthetic
components to, such as but not limited to knees, feet, stubbers,
connectors, or other conventionally used components which are used
distal to a socket apparatus. The particular attachment means may
be any conventionally used means, including plates, screws, gunk,
and others.
[0178] Extended from the general attachment area 101 may be a
stabilizing unit(s) 102. The stabilizing unit 102 may be affixedly
connected to the general attachment area, or may utilize elements
floating in relation thereto. The particular contouring of the
stabilizing unit 102 may be formed in any number of orientations
and trim line cutouts, including various widths, heights,
contouring, shape, attachment means, and other such elements. The
stabilizing unit 102 may extend along any particular side of the
limb, including but not limited to along the medial side, lateral
side, anterior side, posterior side, or at an angle from one side
distally, to a different side proximally.
[0179] Conventional transfemoral interfaces typically largely
circumferentially wrap around the limb, and provide a rigid support
under the tuberosity area, as illustrated in FIG. 5. With invention
100 however, in a preferred embodiment, the stabilizing unit 102
may generally extend up the medial aspect of the limb near or
between the quadriceps and hamstring muscle groups, or up the
lateral aspect of the limb near or between the hamstring muscle
group and the quadriceps muscle group, or along the anterior aspect
of the limb near or between the hamstrings muscle group and
adductor muscle group. The anatomical contouring between those
groups may allow for a slight twist to the stabilizing unit 102 as
it moves proximally up the limb, as is illustrated in FIG. 1C.
[0180] In a preferred embodiment, the stabilizing unit 102 may be
relatively rigid to allow for support of the forces imposed through
the device. The width of the stabilizing unit 102 may be tailored
to individual user's needs, and those illustrated in the figures
should not be considered limiting.
[0181] In a preferred embodiment, there may be an additional
stabilizing unit 102B, which may generally run proximally from the
attachment area up the relatively opposing aspect of the limb.
Additional stabilizing units may be used, and should not be
considered limiting. While this element may not be required to
achieve the desired outcomes, it may provide for added stability.
In such an example, this stabilizing unit may have a similar
rigidity as the medial stabilizing unit 102. Each stabilizing unit
may generally contour according to the shape of the underlying
limb, or may be relatively generic in shape, contouring to a
generic limb. The particular placement, shape, rigidity, number,
material, and other characteristics of such a stabilizing unit may
be modified on a case-by-case basis according to the particular
user's needs.
[0182] While the material selection may allow for rigidity of the
stabilizing units, because of their inherent shapes they may
exhibit somewhat of flexibility in certain directions. To create a
solid enough structure for supporting the user through the
prosthetic interface, connector means may be used to attach either
a stabilizing unit to itself, or to attach two or more stabilizing
units to each other. This may be accomplished through using
compliant members.
[0183] Instead of using an encapsulated socket as in conventional
fitting approaches, the invention 100 may use fabric based or
compliant based members to encapsulate portions of the limb, or may
encapsulate a significant portion of the limb.
[0184] Referring specifically to FIG. 1A, stabilizing unit 102 may
generally contour to a limb. In such an example, it may as well
incorporate other elements such a padding or foam to help further
contour to the specific underlying anatomy of a user. Stabilizing
unit 102 may as well incorporate modular elements to modify its
height, angle, length, or other adjustable aspects.
[0185] In general, stabilizing unit 102 may offer general or
specific contouring for the ischial seat toward its proximal end,
as in the use-case of it running along the general medial aspect of
a transfemoral limb, or may utilize a sub-ischial design. It may as
well wrap around the distal aspect of a residual limb, as
illustrated in distal area or section 103, whereby a relatively
small area is encapsulated to seat the residual limb into. Or, the
distal area 103 may offer a larger area where the distal aspect of
the residual limb may be encapsulated.
[0186] In a preferred embodiment, the predominant amount of force
may be taken proximal to the distal end of the limb, and the distal
end of the limb may have a relatively small amount of total force,
or even no force, as illustrated in FIG. 1A. In such a case, the
majority of the loading force through the system may be along the
stabilizing unit, proximal to the distal end. Where minimal force
may be encapsulated within the distal aspect of the limb, such an
area may extend for a portion up the socket interface length, and
may resemble the lower portion of a conventional socket interface
in shape. Likewise, distal area 103 may extend the full length up
the socket interface shape for a flexible inner socket as is
traditionally used for such level of amputation, and may be able to
be utilized on an existing flexible inner socket interface. Even
further, distal area 103 may utilize compliant materials to
encapsulate the distal end of the residual limb, thereby hammocking
the distal end of the limb in a compliant material, which may
include a fabric or other compliant materials.
[0187] FIG. 1I generally represents various possible cross sections
of a proximal top-down view of an embodiment of the stabilizing
unit 102, as may be affixed to the medial or lateral aspect of the
transfemoral limb for instance. Such stabilizing unit may utilize
one or more components of the stabilizing unit to be affixed to the
distal attachment area 101, which may be modularly adjustable or
not modularly adjustable in angulation, length, or position, or
other orientations as may be desirable. Extended from the distal
attachment area 101 may be structural elements, which may include
tubes 114, poles, struts 115, padding 116, or other such pieces,
including any combination thereof, or may be custom fabricated as a
single or multiple pieces, any combination of which used
individually or together which may have enough structural integrity
to support the necessary forces to generally support the user. Such
pieces as a unit may help hold orientation about the limb, and may
generally contour with respect to long bone 117, generally causing
a portion of the stabilizing unit to reside anterior to the long
bone (anterior lateral, or anterior medial as the case may be), and
one portion of the stabilizing unit to reside posterior to the long
bone (posterior lateral, or posterior medial as the case may be).
By doing so, the long bone may generally be held in a certain
orientation with respect to the stabilizing unit, as the force
distribution anchors may be tightened toward it, generally reducing
the medial/lateral dimension of the interface. Stabilizing unit may
be constructed of at least one independent component(s), with any
such various components connected to the distal attachment area
independently, and as a total working together as a unit. One
example illustrated in FIG. 1I demonstrates the use of two
independent components attached to the distal attachment area.
Another example illustrates a single component attached to the
distal attachment area. And a third illustration demonstrates a
hole cut out in a single component, so that the distal end of the
long bone may be relieved. Such illustration examples should not be
considered limiting, as one or any other number of the examples may
be used, or used in combination through the length of the
stabilizing unit.
[0188] Force distribution anchor 105 and 106 may be positioned
around the general opposing side of the limb, and may utilize a
span of distance between their sub-components. The distance between
force distribution anchor components 105 and 106 may be modularly
adjustable, and may utilize a compliant material 107 between
anchors 105 and 106. The term compliant materials should not be
considered limiting and in general may include a range of
compliancy. For example, this may include materials such as fabric
or mesh fabric, as well as materials like foam padding, fabric
straps, VELCRO, or thermoplastic ladder straps for typical ratchet
mechanisms--each of which are compliant, and may offer appropriate
levels of compliancy for different use-cases. Some use-cases
require very flexible compliancy, whereas other use-cases may
require a form-factor to be generally held, while still being able
to be conforming under load. In general, the term compliant shall
signify any material that is conforming to the body under the given
load that is imposed on it, and which conforms an appropriate
amount for the given use-case. Force distribution anchors 105, 106
may be fabricated of a relatively stiff material, or may be highly
compliant. In a preferred embodiment, they may be stiff enough to
hold their form with respect to the limb, and may be used as an
anchor point for attachment means within the system. The force
distribution anchors 105, 106 may be relatively narrow long shapes
as illustrated in FIG. 1A or may offer other various shapes, such
as but not limited to that which is illustrated in FIG. 10. Their
specific shape should not be considered limiting, as they may be a
modular component, or may be customized to fit a particular user,
who may have particular shape dependent needs. Force distribution
anchors 105, 106 may as well utilize markings to help a
practitioner determine appropriate trim patterns or hole patterns
for modularity. They may also offer spring response, so that during
ambulation on the device, they may provide shock absorption for the
user.
[0189] In another embodiment, the force distribution anchors 105,
106 may be fabricated from flexible materials, such as but not
limited to wires, to manage the forces for their intended
function.
[0190] Attached to the force distribution anchors 105, 106 may be
adjustable or non-adjustable connectors 108 that may connect the
force distribution anchors to the stabilizing unit. These
connectors may allow the force distribution anchors position to be
modularly adjustable with respect to the stabilizing unit. There
may be any number of connectors, and connector types that may be
utilized, and the particular use of connectors in the figures
should not be considered limiting. The connectors may even utilize
fabric spanned to accomplish the same.
[0191] In a preferred embodiment, the connectors may incorporate
areas which may maintain a certain curvature shape which may
generally resemble the arc around a residual limb, whereas to help
prevent the connectors from roping across the limb. In such an
example, the connectors may utilize incorporated more rigid
elements which may as well provide some spring response during
ambulation, or may be rigid enough to not allow spring response. In
general, such features may help prevent the connectors from digging
into or roping into the limb as they arc around the curvature of
the limb. Likewise, a broader material may be used to help spread
the load across, thereby preventing them from digging into the
limb.
[0192] FIG. 1B illustrates such an embodiment, where broad
compliant fabric 109 or other compliant materials may be used to
connect the force distribution anchors to the stabilizing unit.
Such span of compliant material may be attached with any
conventional attachment means, and such material may utilize
connector means that may be modularly adjustable to allow for ease
of tightening to a desired length.
[0193] FIG. 1D generally represents an embodiment of a force
distribution anchor with connectors attachments on one side, in
order to give a representation of how they may integrate within
such an element. In such an example, there may be various materials
used on within the force distribution anchor to allow for certain
areas 111 to be more rigid and certain areas 112 to be more
flexible, to allow for an effective tapered transition of forces as
it sits around the body. Additionally, as fabric or other compliant
materials may be stretched from one stabilizing unit to another,
and so forth, the fabric itself may create the soft transition from
one structural element to another.
[0194] In addition, the connector means, which may be used to
connect either force distribution anchors with each other, or force
distribution anchors to stabilizing unit, may have semi-rigid
elements or customizable elements to provide a set curvature. In
doing so, it may help prevent the connector means from roping into
the soft tissue as they curve around the limb. Further, the
integration of other compliant materials such as fabric to span
there between may be used to prevent roping, as it would
effectively spread the forces over a broader surface area.
[0195] In between the force distribution anchors may be compliant
fabric 107, which may or may not be modularly adjustable, to
determine the span in between the force distribution anchors.
Likewise, a rigid, semi-rigid, or other flexible means may be used
to connect the force distribution anchors together, including
forming the force distribution anchors together as a single
continuous piece with like or dislike materials. It should
therefore be understood the force distribution anchors may function
as a unit, giving general opposing force to the stabilizing unit,
and as such, may be considered a functioning single unit.
[0196] FIG. 1E generally represents an embodiment of how compliant
fabric, fabric mesh, or other compliant materials may be spanned
between a force distribution anchor system of one continuous piece.
In such an example of embodiment 1E, the fabric may generally be
bridged somewhat similar to a hammock between the force
distribution anchor elements. Such assembly may utilize connection
means to the stabilizing unit 102, or may use force distribution
cabling run through such fabric to create a "paddle" of fabric. The
perimeter outline shown in the figure may generally follow what
becomes the curvature of the fabric paddle, as the force
distribution cabling may be stretched there between in a certain
configuration to cause the paddle to represent a pringle-shape, or
other shapes may be utilized as well. The force distribution
cabling may be complaint, though may cause the structure, which
includes the compliant fabric stretched there between, to create a
structural unit. Such structure may additionally include attachment
means 110 to connect to the stabilizing unit 102. Additional fabric
may be spanned between the paddle and the stabilizing unit 102.
Additionally, other attachment means may be used to span to connect
between as well.
[0197] FIG. 1F is similar to FIG. 1E, except that the force
distribution anchors may be of a more structural nature formed as a
continuous piece, or as a combination of multiple pieces configured
to create a structure. FIG. 1E may represent a compliant continuous
piece, or combination of pieces. Both examples may utilize fabric
or other compliant material spanned in between to further spread
out the load across the user's limb.
[0198] Still further FIG. 1G may represent an embodiment where the
force distribution anchors may be connected together with a
semi-rigid strut element, which may alternatively be semi-flexible,
which may generally span away from the limb, so that as the force
distribution anchors may be pulled toward the main stabilizing unit
with their connection means (not shown in the figure), the force
distribution anchors may press into the limb tissue. As such, there
may also be fabric or other compliant material spanned between the
force distribution anchors in addition, all of which may be
modularly adjustable in their varying orientations, positions, and
general effective contouring about the limb, to modify how they
interact with the soft tissue of the limb.
[0199] Referring to FIG. 1C, and of which may generally be relevant
to and embodied within other embodiments as well, on the proximal
end of the interface, invention 100 may utilize a compliant
structure to contour around the underlying anatomy, which may
generally run from approximately near, at, or posterior to the
adductor muscle group region toward the proximal end of the
interface connecting at or near the stabilizing unit 102, and run
generally around the posterior, or medial/posterior aspect of the
limb toward the trochanter area of the lateral aspect of the upper
thigh, which may attach to stabilizing unit 102B, or may continue
further around the limb back to the adductor region connection
point(s). In one embodiment, this element may simply connect the
stabilizing unit to the posterior lateral force distribution anchor
area, whereas it may generally be positioned near the gluteal fold
region, to provide at least one of contouring, comfort, and control
of the device.
[0200] FIG. 1H generally represents an embodiment where stabilizing
unit 102 may generally extend from distal attachment area 101
proximally up the general lateral aspect of the limb, and whereas
the force distribution anchor 105, 106 may generally extend across
the medial aspect of the limb. As such, the anterior force
distribution anchor may generally sit near or between the
quadriceps muscle group and the adductor muscle group, while the
posterior force distribution anchor may generally sit near or
between the adductor muscle group and the hamstring muscle group.
In such an embodiment, the femur may generally be pulled laterally
toward the stabilizing unit, and such stabilizing unit may exhibit
a general angulation similar to the desired femoral angle.
[0201] Embodiment 1H may generally utilize a load bearing compliant
member or structure 200, which the user may rest into during load
bearing. Such unit may be incorporated within the force
distribution anchor assembly or may be independent from such. By
being compliant, such unit may provide increased comfort for the
user, versus the traditional rigid ischial/ramus/tuberosity shelf
found in conventional transfemoral sockets. As such, this element
may function somewhat similar to the medial/posterior aspect of a
rock climbing harness, in that some of the weight bearing of the
unit may be bore in soft compliant materials, versus rigid
structures. The lateral orientation of the stabilizing unit may
allow the compliant member 200 generally be supported in the
correct orientation with respect to the body.
[0202] This compliant member 200 may be utilized with stabilizing
unit alone, or may incorporate force distribution anchors to assist
in managing the direction and orientation of the forces through the
system. It has been found clinically that the integration of the
force distribution anchors within such an embodiment may provide
added control and comfort.
[0203] In such an embodiment, the stabilizing unit extended up the
general lateral aspect of the limb generally may make it more
conducive for more of a generic shape to fit to a wide variety of
limbs, versus having to be custom fabricated.
[0204] In an embodiment where stabilizing unit may extend up the
lateral aspect of the limb, an opening 113 may exist in such
stabilizing unit to allow for the long bone and/or tissue
surrounding the long bone to fit within. As such, the distal end of
the long bone may have space to press into a space where there is
no rigid structure. This space may be spanned with no material, or
may be spanned with compliant fabric to further control tissue
flow. It is understood that such opening may be in any width,
height, contouring, or shape as may be best suited for the
particular patient, or for human anatomy as well. Stabilizing unit
may exist in various subcomponents to allow for such opening to be
created, including but not limited to disconnected anterior and
posterior support sections, each of which may be connected to a
distal and/or proximal end together, or to other such structure,
including structure 101. Such opening may also be used where the
stabilizing unit resides along the medial aspect of the limb.
[0205] In general the term medial and lateral are in particular
reference to a transfemoral use-case, and for other use-cases such
as transtibial, transradial, transhumeral, or for orthotic
applications, the particular orientation of the compression may
best be utilized in an orientation other than medial/lateral, such
as but not limited to anterior/posterior, and as such the general
terminology should not be considered limiting, as the terms
medial/lateral for the stabilizing unit and force distribution
anchors general opposing force directions are for example purposes
only for the transfemoral use-case, to allow one skilled in the art
to better comprehend how they may relate with one another.
[0206] Amongst FIGS. 1A-1I general embodiments, force distribution
anchors may generally float with respect to the stabilizing unit
102. By doing such, their circumferential position about the limb
may be modularly controlled, allowing for full accommodation to the
user's limb size and shape. Furthermore, if two force distribution
anchor components are joined together as one unit, they may be
positioned on either side of the long bone of the limb segment,
allowing the more compliant material spanning in between, which may
also be an area without material spanned in between, to be
positioned over the long bone. By doing such, the force
distribution anchors may effectively help lock the bone position
such that the long bone is generally controlled during ambulation,
through using the device. The compliant material, which may span
between the force distribution anchors may allow for the sensitive
distal end of such bone to be free of contact with any rigid or
semi-rigid surface. One component of the force distribution anchor
may generally reside on the anterior side of the long bone
(anterior/medial, or anterior/lateral depending on orientation of
the stabilizing unit being laterally or medially orientated), and
one component of the force distribution anchor may generally reside
on the posterior side of the long bone (posterior/medial, or
posterior/lateral depending on the orientation of the stabilizing
unit being laterally or medially oriented).
[0207] As the force distribution anchors may be tightened toward
the stabilizing unit 102, it may generally shorten the
medial/lateral dimension of the interface, as in the case of using
this on a user with a transfemoral amputation for instance. In such
a case, the long bone may be generally pulled toward the
stabilizing unit, and maintained in such a position, as is
referenced in FIG. 7 with the desired femoral angle. To accomplish
this, the limb tissue may need to be displaced, in which the
anterior and posterior dimensions may allow for the material to be
displaced into, so that the medial/lateral aspect of the interface
can be tightened to control the bone. The force distribution
anchors may work in coordination with one another as effectively
one unit locking the femur from the anterior and posterior sides,
along with any material that may connect between the two, to
control the position of the long bone.
[0208] It should be understood that while the invention is
described in these configurations. Further, embodiments from FIGS.
1A-1I may be utilized on other levels including transhumeral,
transradial, and transtibial levels with similar advantages as for
a transfemoral level. Still further, embodiments illustrated in
FIGS. 1A-1I may also be utilized in similar orthotics and
exoskeletal robotics levels to control the underlying limb
segments. The shapes of the stabilizing unit and force distribution
anchors may embody many various configurations, and those
illustrated and discussed should not be considered limiting. The
general principles how such pieces may connect together, and how
the pieces may work together to control the limb can be
accomplished with a variety of configurations.
[0209] Referring to horizontal section or attachment means 208 as
illustrated in FIG. 1C, the compliant structure 200 may generally
be used to support load bearing of the user within the device. This
element may be utilized in any of the embodiments, and generally
may be spanned near or as the proximal posterior connector, running
along the gluteal fold region. Instead of solely supporting the
user's weight volumetrically through the whole limb as in
conventional devices, a sizable amount of the vertical loading may
be bore through such compliant member, and specifically it may run
near the gluteal fold region to help accomplish the soft tissue and
anatomical contouring as loading. Through using it in the
configuration where it may extend further under the medial aspect
of the limb as well, it may utilize ischial loading as well. This
may function similar to how a rock climbing harness suspends its
user, though may be accomplished here for use in prosthetics
interfaces. This compliant member may further extend to or past the
ischial area, so that such area may be supported by a compliant
member, similar to how a rock climbing harness may function,
instead of using a rigid or semi-rigid seat as in conventional
socket interface designs.
[0210] FIGS. 2A-2B generally show a preferred embodiment of such
compliant structure 200, here specifically depicted as a gluteal
stabilizer. The structure may encompass adjustable attachment means
on its medial and lateral sides. These attachment means may be any
commonly used in the industry, and those depicted should not be
considered limiting, but may include user adjustable means, or
non-user adjustable means, or a combination of both. The compliant
nature of the compliant structure itself should, in a preferred
embodiment, lend itself to a formed shape, while maintaining
compliancy.
[0211] The attachment means may allow for adjustability in fit
through tightening or loosening the compliant structure, changing
the circumferential dimension of the interface. It may also be used
to connect the stabilizing unit(s), which may provide added
structural support of the interface unit.
[0212] It may encompass various materials of various degrees of
compliancy to maintain such, including but not limited to fabric,
foam, plastic, or other generally compliant materials. In general,
the compliant structure may conform around or near the gluteal fold
area of the body on the posterior side of the body. It may also
offer a level of arc or concavity 203, which may help to contour
into the soft tissue between the hamstrings and the buttocks.
[0213] The compliant structure 200, in a preferred embodiment, may
have asymmetrical contouring as depicted in curvature or section
201 versus curvature or section 202, and curvature or section 204
versus curvature or section 205. In such an example, the curvature
or section 201 may be notably different than that of curvature or
section 202 to contour over various users differently. Some users
may benefit from curvature or section 202 positioned on the distal
aspect of the structure. Conversely, other users may benefit from
the unit being positioned 180 degrees, with the curvature or
section 201 positioned on the distal aspect of the strap. Having a
reversible design may allow for better user contouring and
success.
[0214] Likewise, asymmetrical contouring of arc 203 may benefit
various users. Positioning the unit with the broader curvature of
section 205 on its distal aspect may benefit those patients with
larger soft tissue areas, which positioning the unit such that
section 205 is positioned on its proximal side may benefit users
with other body shapes.
[0215] The compliant materials of invention 100 may as well benefit
from accessory elements such as integrated nanotechnology or other
technologies to provide various characteristics that benefit the
functional or user performance or experience with the device. These
may include, but are not limited to, sensors, hygiene elements,
antimicrobial elements, water repellency, or others.
[0216] This structure may as well integrate in purposed contouring
to fit around the tuberosity and ramus areas of the body. This area
may offer differing degrees of conformity or rigidity, in order to
provide the necessary support for the user's needs.
[0217] There may be a generally similar compliant structure
connecting the medial stabilizing unit 102 to lateral stabilizing
unit 102B, as well as others as integrated. This may be used to
help provide added structural stability of the interface unit, as
well as provide sufficient comfort for the user on the proximal
anterior aspect of the interface.
[0218] FIG. 3 generally illustrates an alternative embodiment of
the invention 100 where the medial stabilizing unit may generally
contour up the medial aspect of the limb, and may further contour
around or near the tuberosity area, providing support through the
stabilizing unit 102, versus directly through the compliant
structure 200. There may also be another connector means running
along the anterior connecting the various stabilizing units.
Additional compliant material may be spanned in between across and
around the general circumference of the limb, to help control
tissue and connect to the stabilizing unit(s).
[0219] FIG. 4A and FIG. 4B generally illustrate similar
configurations as shown in FIG. 1A and FIG. 3, although utilizing
just medial stabilizing unit 102, versus in combination with a
lateral or other numbers of stabilizing units. In such an example,
other compliant members may additionally be integrated to prevent
user movement within the device in certain orientations of
movements. One such example of such may be to connect the proximal
lateral aspect of the proximal circumferential unit as show, to the
distal lateral aspect of the anchor stabilizing unit to prevent the
circumferential unit from migrating proximally. This can be
controlled with a compliant strap, versus a rigid element. Further
areas of the open areas may be spanned with other compliant
materials, including but not limited to compliant fabric mesh.
These other materials may be used to provide control of the tissue
of the limb. The use of such circumferentially spanned fabric may
help to encapsulate and control the limb tissue through stretching
it tighter or looser in certain areas and directions about the soft
tissue. The illustrations in FIG. 4 may as well utilize force
distribution anchors as illustrated in other embodiments as well.
These are not shown in this figure for simplification purposes, and
therefore should not be considered limiting.
[0220] FIG. 6A generally illustrates the integration of a femoral
stabilizer unit 600 integrated within the invention 100. In such an
example, the general dynamic characteristics of the femoral
stabilizer unit may be similar to the compliant structure 200,
though may contour specifically around and proximal to the distal
aspect of the femur bone. Its contouring may generally utilize
3-dimensional contouring sections to best contour around the
underlying anatomy. It may offer lowered sections or attachment
means 208A and 208B to post either side of the femur bone, and a
raised section 209 in between to allow the actual distal femur to
not be impinged.
[0221] Adjustable connectors 210 may be used to allow for user
adjustable tightening of the femoral stabilizer. The purpose of
such a compliant structure may be used to not only post the
sensitive distal aspect of the femur from the interface, but just
as importantly, may help maintain femoral stability and femoral
angle, thereby providing for a greater biomechanical stability of
the femur within the interface. This will lead to greater control
and stability for the user, as their bony structure within the
residual limb will be more closely locked to the prosthetic
movement. Such a femoral stabilizing unit may be used independently
from, or in combination with force distribution anchor
structure.
[0222] This femoral stabilizing unit structure may be attached at
more than one location on each side, and may utilize other
attachment sections (not shown in the figures) to provide increased
positional stability of the unit with respect to the user's limb
orientation. It should be understood that the illustration
described in FIGS. 6A-6B may be functionally similar to that
described in FIGS. 1A-1I, whereas the long bone may be more
advantageously controlled by a connected, yet floating, element,
which may contour around the long bone in a way as to control its
movement within the device.
[0223] Such an element may help maintain femoral stability within
the design. FIG. 7 illustrates the femoral angle that should be
maintained within a socket interface device. However, due to the
cut end of the femur bone not being connected to the rest of the
limb, the femur tends to move anterior/posterior, as well as
medial/lateral during walking. This movement decreases stability
and gait efficiency.
[0224] FIG. 8 demonstrates several of the evolutionary iterations
of transfemoral socket design that have been used to help maintain
femoral stability, as well as comfort and provide control of the
limb. From left to right, these include: Plug fit socket, quad
socket, Sabolich socket, MAS socket, Hi-Fi socket. Besides the
Hi-Fi, each uses a hydrostatic fit, and all versions rely on
enclosing the limb within an encapsulated thermoplastic socket, and
none provide volume accommodation. Of these, only the Hi-Fi socket
does an adequate job controlling the femur within the soft tissue.
As one can see, the same anatomy of the human thigh can fit within
many different shapes, and all of which may allow a user to
effectively walk on their prosthetic device. This large variety of
fitting methods is somewhat due to the compliant nature of the soft
tissue of the thigh; however, each design offers different degrees
of comfort and bony control. This may also suggest that the
stabilizing unit as generally illustrated in FIG. 1 and others may
be an off-the-shelf shape, which may be somewhat customizable to
the user either through adjustment means or compliant materials
incorporated within such as padding, to allow for a conforming and
comfortable fit.
[0225] FIG. 9 generally shows how the muscles and bone fit within
one version of a conventional socket design, in this case, showing
an antiquated quad socket.
[0226] FIG. 10 shows an embodiment of invention 100 wherein the
femoral stabilizing unit may be integrated within a vertical
oriented force distribution anchor unit. Additionally, it may be
integrated within a stabilizing unit or may be generally floating
and connected to a main stabilizing unit via connectors. In such an
example, there may be a main medial stabilizing unit, connected to
floating anterior and/or lateral force distribution anchors. There
may also be other numbers or locations, or contouring of such
stabilizing units and force distribution anchors, and the
illustrations should not be considered limiting.
[0227] In between the various force distribution anchors and
stabilizing unit sections within the various embodiments may be a
compliant fabric, which may include, but not limited to a mesh
material. Such a material may offer breathability, coolness,
lightweight, and durable design. In such an example, it may help
encapsulate the limb tissue, providing for increased comfort and
control. Even further, such compliant material may help post the
distal femur and may allow the distal femur to contact only
compliant fabric, versus rigid structure.
[0228] FIG. 11 demonstrates the benefit of integrating compliant
fabric within the interface design, as it allows for a gradual
transition from high forces to no forces. The fabric is not
specifically illustrated in the figures for simplicity, though
would reside between the various stabilizing elements, as may be
integrated within the compliant fabric-based socket element. As a
fabric may extend from a stabilizing element, the underlying tissue
may be controlled at the transition points, allowing for gradual
transitions of pressures, versus typical sharp transitions as is
typically found in conventional fitting methods.
[0229] In addition to the socket contouring as depicted in the
various illustrations, there may as well be a distal cup or distal
socket area, which the limb may reside (not shown in some of the
illustrations). This may allow for any portion (from partial to
full) of the limb to be encapsulated, allowing for suction or
vacuum suspension to be achieved. This element may be fabricated
with conventionally known methods and/or materials. Still further,
the user may use a gel liner or other compressive sock or the like
in conjunction with invention 100, which may allow for suspension,
and tissue encapsulation and control as desired. The gel liner for
example may be used independently or in conjunction with other
flexible inner socket elements.
[0230] Invention 100 may be used in coordination with an existing
socket design, or with a conventional flexible inner socket
integrated, such that the force distribution anchor assembly may
advantageously be used to improve the fit of an existing socket, as
well as minimize the complexity of fitting a conventional socket,
as invention 100 may help to improve modularity and adjustability
of the fit around a user.
[0231] The compliant force distribution socket may encapsulate the
limb with compliant materials, such as but not limited to fabric
mesh, and may eliminate the non-breathable hot and heavy
thermoplastic socket. It may utilize isolated regions of compliant,
yet stabilizing zones, and a broad distribution of forces to
support the limb and minimize point pressures.
[0232] Each may be connected with adjustable connectors to allow
the user to tension the tightness to a preferred comfort. The
stabilizing unit segments and the compliant fabric may be
adjustable--allowing for the clinical fitting process to be
modularly customizable to the user, as well as user-adjustable for
preferred security and comfort.
[0233] The medially oriented stabilizing unit may key into the soft
limb tissue generally near or between the hamstrings and adductor
muscle groups, and a lateral oriented stabilizing unit may
generally position near or between the hamstrings and quadriceps
muscle groups, and an anterior stabilizing unit may generally
position near or between the quadriceps and the adductor muscle
groups. The various stabilizing units along with opposing force
distribution anchors together may provide opposing forces, locking
the limb in relation to the interface, and hence providing an
improved link between the intended musculature and bony structure
movement of the body with the movement of the prosthetic limb. The
less the bone moves within the soft tissue, the better
biomechanical and neuromuscular control will be achieved, reducing
energy expenditure of ambulation.
[0234] As each of the stabilizing units and force distribution
anchors may be separate, yet linked, there is an infinite amount of
modularity and user adjustability, creating a fully customized fit,
and ability to accommodate for residual limb volume change. The
predominant surface area of the interface may be open, or mesh
fabric, allowing for breathability and heat dissipation. It may,
but not necessarily be, generally utilize conventional socket shape
contouring, with the added benefit of adjustability between the
various stabilizing unit segments.
[0235] This design may also allow for significantly lower trim
lines at the proximal brim, and may not necessarily require
specific brim elements as in conventional socket designs.
[0236] FIG. 12A generally illustrates an embodiment where the force
distribution anchors may not float, but rather may be structurally
connected. In such an example, force distribution anchors 1201 and
1202 may generally run in an orientation along the long bone. In
between them may be modularly adjustable connector means, which may
also include compliant fabric. Connector means 1203 may allow the
force distribution anchors to be pulled toward each other,
tightening the interface about the limb. As fabric may be spanned
or stretched in between the anchors, any long bone movement that
may tend to press lateral, as in the case of a transfemoral
amputee, may tend to push into the soft fabric, versus a rigid
structure. In this embodiment, the interface may be fabricated to
be slightly undersized for the user, thereby allowing it to have
inherent compression about the limb, and inherent bony control. As
the system may be tightened to the user, it may provide added
compression. In general, a tight medial/lateral compression may be
used, to help control the bone, and allow the tissue to bulge out
the other areas. Not illustrated in FIG. 12A, but is in FIG. 12B,
at the distal end may be a connector means to attach to other
typical components used along with such a device. Such an
embodiment may also utilize a vertical anchor stabilizer 1204 along
its general medial side, as illustrated for a transfemoral
use-case, to prevent flexing of the structure. Additionally,
padding or other compliant materials may be integrated to add
comfort and conformability to the user.
[0237] FIG. 12B represents an embodiment as donned onto a
transfemoral use-case. This illustration does not show the
connector means, but it should be understood that they may be
integrated into such a system.
[0238] FIG. 12C represents an embodiment as donned onto a
transhumeral use-case, and as may be used for non-prosthetic
man/machine interface connectivity.
[0239] FIG. 12D represents an embodiment as donned onto a
transhumeral use-case.
[0240] In each such case, the connector means 1203 may be used to
draw the force distribution anchors together, tightening the
interface around the limb, and providing control of tissue and bony
anatomy.
[0241] Such embodiments may also be used on other use-cases
including transtibial, and transradial levels, and all such
corresponding orthotics levels to control the limb segments. In any
such orthotics use-case obviously an open end may be used, as the
limb may extend past the end of the device. Furthermore, any such
embodiments in this disclosure may be used in exoskeletal robotics,
as they are merely advanced orthotics devices.
[0242] FIG. 13 represents invention 100 donned onto a transfemoral
amputee use-case. This illustration shows how the distal end of the
interface may be contoured to the distal of the residual limb. This
illustration also shows the proximal end of a flexible inner
socket, gel liner, or other compressive sock 1301 to control
tissue, as may be worn with the device.
[0243] FIG. 14 represents invention 100 donned onto a transfemoral
amputee use-case. This illustration shows how the distal end of the
interface may purposely be in non-contact with the distal end of
the residual limb structure. In such an example, the distal end of
the limb may be suspended with compliant fabric 1401 to give a
similar effect as a rigid structure's support, but with compliant
means. This fabric section may be spanned from the stabilizing
unit(s) and force distribution anchor(s) distally to their
corresponding components proximally to provide an anchor for its
attachment.
[0244] Likewise, such a system may be used for casting of a custom
medial or lateral anchor, whereas the remaining elements of the
invention 100 may be integrated to such a casting jig, in order to
cause the plaster which may be wrapped around the residual limb to
be specifically contoured to the underlying anatomy as the force
distribution stabilizing units are tightened down to the user.
Integrated fabric may assist in capturing the contouring of the
distal end within the casting process. Similarly, the fabric may be
spanned around much of the limb, creating a hammock containment of
the limb within fabric, replicating or replacing a rigid interface
that is conventionally used to hydrostatically manage the limb
shape.
[0245] In an expanded modular embodiment, the stabilizing unit may
be of a fully modular or modular semi-customizable component, which
may either attach directly to the limb components, or may attach to
a customized distal connector, which may attach to the limb
components, as illustrated in FIG. 15. It is also understood that
other numbers of force distribution stabilizers or anchor
stabilizers may be used, and their shapes, sizes, orientations, and
configurations illustrated in the figures should not be considered
limiting.
[0246] In such example, attachment means 1501 may be any attachment
method to known in the field, which may provide a structural
attachment, and that in the figure is meant for illustrative
purposes only. In such an example, the distal end of socket 1502
may be customized by the clinical practitioner, and modular
stabilizing unit 1503 and force distribution anchors 1504 may be
modularly connected within the system to make a complete interface,
along with other sub-components. As described previously in FIG. 8,
over the years there have been a number of socket design iterations
which the human above knee limb can fit into, and all of which have
radically different socket shapes. This tells us that the human
thigh can fit within many different shapes, where the stabilizing
unit may reside. As such, an off-the-shelf stabilizing unit may
come in various sizes, or may offer other compliant means such as
padding, and may generally offer a shape that resembles that of the
underlying anatomy, in which it may contour around. Likewise, there
may be any number of stabilizing units, which may be modularly
connected to a common customized distal attachment.
[0247] The embodiments represented may be custom fabricated, or may
be pre-fabricated and sized to fit a variety of users, or may
utilize a combination of both. Since they offer so much inherent
modularity, a select few sizes will fit a variety of sizes of
users. Additionally, conventional suspension systems available
within the field may be used in conjunction with this design,
including but not limited to distal cup or full length socket to
provide vacuum or suction suspension, and which may be integrated
into the invention.
[0248] Invention 100 may utilize at least one, possibly two, or
more, stabilizing unit(s) to be modularly connected to distal base.
In one embodiment as illustrated in FIG. 16, stabilizing unit may
have a rigid or semi-rigid section 1601, which may extend up the
length of stabilizing unit, or may attach to a separate stabilizing
unit section, which may resemble the force distribution anchors in
general shape or characteristics. Such base of the stabilizing unit
may be connected with adjustable base 1602. Such adjustable base
may utilize any adjustment means known, and those illustrated
should not be considered limiting. In one embodiment, adjustable
base may utilize a male to female pyramid setup 1603, where
stabilizing unit section may be modularly adjusted in angulation.
The opposing pyramid section may be modularly connected to a base
plate such that the pyramid section may be adjusted in XY position
on the base plate so that the desired femoral angle, weight line,
and general biomechanics of alignment may be realized for the
particular user. Connected to such base plate may be a mounting
point 1604 for other prosthetic components. Alternatively, other
attachment means may be used, and should not be considered
limiting. Such base plate may be fabricated from metal, carbon
fiber, or other such materials that may be sufficiently strong
enough to support the user's weight and forces. Holes may be placed
in the material to modularly adjust the mounting positions of the
various components.
[0249] PADS:
[0250] As is generally illustrated in FIG. 17, in a preferred
embodiment, such force bearing elements including but not limited
to the struts, connector pieces, adjustable connector sections,
gluteal span, or others, may utilize padding on their inner side to
provide a more comfortable and gradual dispersion of forces about
the limb.
[0251] In a preferred embodiment such pads may be modularly
removable, in order to modularly replace the pads. The pads may
utilize any conventional attachment means including but not limited
to VELCRO, sticky material, fasteners, mechanical means, slots, or
others.
[0252] Such pads may be available in various characteristics such
as but not limited to thickness, durometer, flexibility,
combination of durometers, combination of flexibility in various
areas, width, tapering, attachment or suspension methods, with
varying surface characteristics, material selection, surface
tension, surface friction, or other such characteristics.
[0253] In such an embodiment, by way of example, a thicker, wider,
or stiffer pad may be used for a patient with a considerable amount
of soft tissue, whereas a thinner or narrower pad may be used with
a patient who is more muscular.
[0254] As may be generally illustrated in FIG. 18, in a preferred
embodiment, the pads may utilize one or more durometers, or other
characteristics as mentioned above. In such an example, a pad with
more than one durometer may utilize areas of higher durometer 1801
and areas of lower durometers 1802. Such areas may be uniform
across the pad, as may be layered, or may not be uniform across the
pad. In such an example where there may be two or more durometers
for example, a higher durometer for instance may be across the
outer surface of the pad in order to increase durability against an
external supporting member, and a softer area of the pad may be on
the inner surface to allow for comfort and conformability to the
user. In addition, other layers of various durometers or other
characteristics may be used such as but not limited to, for
example, yet another area of slightly higher durometer on the inner
side of the pad to help disperse the forces more broadly by a
middle softer section's compression. Similarly, the pad may utilize
surface coatings or other materials adhered to its surface to
accomplish the same. By way of example, fabric, VELCRO, plastic,
nanotechnology, gecky-inspired technology, or other materials may
be bonded or adhered to at least once side of a pad in order to
provide such varying characteristics of the pad assembly, including
suspension capabilities. The pad may be connected to a supporting
or medial member by VELCRO or other commonly used connector means
1803.
[0255] Likewise, external materials or pad materials may have
varying degrees of surface tension, friction, or sticksion.
Materials may be used that have a high coefficient of friction
against the underlying limb or liner, or it may have a low
coefficient of friction to prevent tension against the limb or
liner. In a preferred embodiment, it is contemplated that higher
tension between the pad and the limb or liner is more advantageous
to prevent the limb or liner from moving with respect to the
pad.
[0256] In another embodiment, VELCRO or the like may be applied to
the inner surface of such pad, or supporting members, in order to
increase the coefficient of friction, or mechanical lock, to the
underlying liner or the like. By doing such, the limb may be
mechanically held within the socket by way of a mechanical lock. In
conventional socket designs, this would be a limiting factor as
doffing the device would be challenging. However, within this
disclosure, the design inherently provides a socket that can be
detached in such a way as to allow the user to effectively doff the
device in a user friendly way.
[0257] As is illustrated in FIG. 19, there may additionally be
various stackable materials 1901 that may each be modularly
connected or disconnected. By way of example, various pads may be
applied in series to allow for a change in thickness, or even
tailoring of contouring by applying additional inserts between such
a supporting element and a pad, thereby changing the shape within
such a system. Such an insert may utilize hook and loop on its two
sides respectively to simply be applied between and attach to
supporting structure 1902 and the pad, or may be connected with any
other known means.
[0258] In a preferred embodiment, and as one possible embodiment
may generally be illustrated in FIG. 20, such pads may utilize
raised or depressed shapes across its surface, in order to help
increase the surface tension or mechanical lock between the pad and
the limb or liner. Such shapes may be formed in many different
characteristics including thickness, width, geometric or
non-geometric shapes, design, texture, or otherwise.
[0259] Such shapes may offer various orientations such that they
may inherently prevent the limb or liner from shifting proximally
or rotationally. As is illustrated in FIG. 21, and by way of
example, such shapes 2101 may have a general angulation such that
the limb or liner is preventing from slipping past them. Such
shapes may compress in certain directions, but expand in others. By
doing so, the limb may be allowed to seat into the socket, but may
be prevented from pulling out of the socket.
[0260] Such pads may be fabricated from one or more of various
types of materials including but not limited to foams, silicones,
rubbers, urethanes, plastics, textiles, mesh, fabric, or other such
materials utilized in the industry or for interface
applications.
[0261] It should be understood that the term liner should not be
considered limiting, and may generally refer to any number of
materials that may be applied over a limb, including but not
limited to a gel liner, gel sock, fabric sock, sleeve, any
combination thereof, or any other material or configuration that
may be applied over a limb within a prosthetic or orthotic
device.
[0262] In an alternative embodiment as shown in FIG. 22, such pads
2202 may be applied within a conventional socket shape 2201 to help
increase rotational stability and/or suspension. In such a case the
existing or conventional socket may be, but not necessarily is
required to be, split in such a way as to be adjustable so that the
socket may be tightened or loosened to accommodate for volume
change, fit, or simplicity of donning and doffing such a system. In
such a case, the insertion of such pads may help lock the position
of the bone of the limb into a certain orientation by virtue of
compressing the soft tissue around it.
[0263] Such pads, materials, shapes, or surfaces may mate with
opposing surface of a liner, in order to increase a lock of the
socket to the liner/limb. If a liner or the like may be used on the
residual limb within such a system, such a liner may utilize a
surface material that may inherently mate with such shapes or
surface structure of such a pad. Such material or materials on the
liner may amplify the effectiveness of a mechanical lock or other
bonding methods with the pads.
[0264] In order to increase the surface bearing area of the
interface about the limb, while maintaining a compliant interface,
in a preferred embodiment, the vertical and/or horizontal
connection section pads may utilize a connection means to an
underlying compliant member that may be donned over the limb, such
as a liner/sock. By way of example, a gel liner may be donned over
the patient's residual limb. Such gel liner may utilize a surface
covering that may have surface tension or other connectivity means
to the interfaces connection sections (such interface connection
sections may include any number of vertical struts, horizontal
connection members, or other such sections). In a preferred
embodiment, such surface to surface connectivity may utilize hook
and loop VELCRO or the like. In a preferred embodiment, utilizing
such a connection across and around a proximal band of the
interface, or any area of such vertical interface sections, or any
combination thereof or other, may allow for the remainder of the
limb to suspend in a hammock-like manner within its gel liner, as
is illustrated in FIG. 23 with VELCRO patches 2301 placed along
supporting members to connect a liner for instance to the socket.
It is contemplated that a similar effect may be achieved with a
fabric sock, donning sleeve, shrinker, or other such compliant
members, which may fit snug over the residual limb. It is also
contemplated that such hook and loop may connect such interface to
an underlying member along such vertical strut sections--which may
include 1, 2, 3, or 4 of such vertical members, with or without
combination with any number of horizontal connection members as
well.
[0265] In such an example, the liner or sock element may have a
certain amount of elongation potential as such material may be
stretchy, or may have inherent compliance. Such underlying limb may
generally be supported by such material, and such connectivity of
such material to an external supporting structure may generally
result in a hammock-type effect, whereas the liner or sock material
may act as a hammock, the supporting structure (such as sections of
the struts of a socket) may resemble a hammock-stand, and the limb
may resemble a person laying in a hammock. In such an example, as a
person may lay in a hammock, their entire body weight is supported
by the hammock itself, which is supported by the hammock stand. In
such an example, the person's full body weight is distributed over
a broad surface area and such hammock is conforming to the shape of
such body, resulting in a comfortable interface. In the prosthetics
equivalent example, the liner or sock may generally support the
user's weight, as well as biomechanical lock about underlying
anatomy. The liner or sock may help prevent expansion of the tissue
in elongation, circumferential expansion, or other, or any
combination thereof. Additional elements may be applied to the
liner or sock to further help control and/or manage the tissue
within the system. In one example, and as described in additional
patent application by this same inventor, a flower shaped connector
may be applied over the distal end of a liner or sock, eliminating
or reducing elongation or circumferential expansion of the liner,
and creating a form fitting socket over the end of the limb.
Likewise, it is contemplated that non-elongating hook VELCRO type
strips, or other methods, may be connected to a liner or sock which
may be not have integrated anti-elongation strips, and such
combination may be used to prevent elongation of such liner or
sock.
[0266] Alternatively, other methods may be utilized to quickly
create a form-fitting socket about a residual limb such as
impregnated at least a portion of a fabric sock or the like with a
material in a general liquid form, which may then hold its form
upon changing it state. By way of example, materials such as
silicon, urethane, or other similar materials may be used. Such
materials may get impregnated into at least a portion of a fabric
sock (or functionally similar article) that is donned over a limb,
and which is then able to set off, providing a form fitting socket
to a user. The sock may give compression to tissue and conforming
around the limb. The impregnated silicon for instance becomes the
structure element, and setting off in the socket gives the
shape.
[0267] Ladder Strap With Numbers:
[0268] In a preferred embodiment, a connector means may be used
which may offer documentable increments of tightness. In one such
embodiment, a ratchet and ladder strap may be used which may offer
numbered or use other increments which may be used to alert the
user or practitioner how tight such a connector piece is. In a
preferred embodiment, such a ladder strap may utilize numbers
listed on various ladder increments. Such numbers may be listed in
order, and such numbers may begin at the mountable end of the
ladder, such that the open end of the ladder may be cut to length,
and allow the remaining numbers to remain in order starting with
the lowest and working upward as it extends to the cut end of the
ladder strap.
[0269] Such numbers may be listed on each ladder section, or may be
listed by increments of two's, five's, ten's, or other. Such
numbers may as well be linear along the strap, or may be offset at
angles to enable the user to better read the position, without
having to fully read the actual individual number. In such a case,
the numbers of increments of fives may be on the far left side for
example, and the following numbers may stair-step in position
across the ladder. The same may be accomplished in sets of 10's. It
is contemplated that only the fives or tens may be listed on the
ladder strap, and the remaining rungs in between may not have
numbers listed.
[0270] FIG. 24 generally illustrates one embodiment of such ladder
strap with numbers along the rungs of the ladder.
[0271] Likewise, cross connector pieces may be used with numbers as
well to alert the practitioner of the position of such connector
between such interface sections.
[0272] FIG. 25 generally shows an embodiment of a cross connector
strap with numbered holes. The hole at least one end of such
connector may be offset by a certain amount to increase the number
of possible positions of such a strap. For instance, if each hole
is 1/2'' apart, the hole numbered 0 may be offset by 1/4'' from the
other holes, such that the entire strap may have 1/4'' increments
with larger hole spacing, providing a more durable strap.
[0273] Components and Fit:
[0274] In a preferred embodiment, modular components may be used to
alter the position and angulation of at least one, and preferably
two, vertical supporting members.
[0275] Such supporting members 2601 may be fabricated from
thermoformable or non-thermoformable materials. In a preferred
embodiment, thermoformable materials may be advantageous to contour
such members to the underlying anatomy, especially on the proximal
end. It has been found that it is not necessary to contour any
supporting member (or medial vertical member for that matter) at
all and maintain full functionality and comfort. Thermoformable
members may be made of thermoformable carbon fiber, injection
molded plastics, or other materials. In a preferred embodiment,
such members may be fabricated from injection molded plastics. Such
injection molded materials may utilize nanotechnology to increase
their strength and rigidity.
[0276] Such vertical supporting members in a preferred embodiment
may generally be positioned along the lateral and/or anterior
lateral aspect of a transfemoral limb for instance. One supporting
member may generally be positioned between the hamstrings and the
lateral aspect of the quadriceps, and generally run from posterior
to the distal aspect of the residual bone to the pocket hollow
area, just posterior to the proximal aspect of the residual bone. A
second supporting member if used may run from anterior to the
distal end of the residual bone to anterior or anterior/lateral
aspect of the proximal end of the residual bone. By positioning
such supporting members like this, the distal end of the residual
bone may generally be positioned to float there between, leaving no
structure in which the sensitive end of the bone may hit
against.
[0277] Between the supporting members, toward the distal end, but
proximal to the distal end of the residual bone, a compliant bridge
1708 may span there between, allowing for a pad to be placed to
post the bone, and control its position and movement.
[0278] In such a system it is contemplated that the distal end of
the residual limb may not need to be in direct contact with the
distal end of a socket, and instead may generally float with no
contact with any rigid or semi-rigid structure. Instead, the use of
a sock or liner may be used as a "hammock" to support, manage, or
control underlying tissue within the system, and functionally act
like a conventional rigid socket may act about the limb.
[0279] It has been shown in conventional socket designs that
encapsulate the limb that a lack of distal contact with the end of
the socket may result in circulatory issues of that tissue, and is
generally contraindicated. However, since this socket design does
not encapsulate the entire limb, and since the hammock effect is
utilized to control and manage the tissue, having lack of contact
about various aspects of the limb including the distal end is found
to be more comfortable by wearers. The underlying limb and tissue
may be supported by a compliant hammock instead of being supported
by a rigid socket.
[0280] The proximal end of at least one of the supporting members
may be connected to a compliant band or swing strap 1704 (FIG. 17)
that may span around the medial aspect of the limb and back to the
other supporting member, or itself. By way of example, such
compliant band may span from the lateral posterior supporting
member around the gluteal area, under the medial aspect of the
groin, around the anterior aspect of the limb, and connect back to
the lateral anterior supporting member. In such an example, such
compliant band may functional similar to how a climbing harness may
function in supporting the body.
[0281] The term compliant band should not be considered limiting
and may encompass webbing, fabric, plastics, foams, laminates, or
any other material. Such band may additional include areas that are
more compliant and areas that are less compliant, and may even have
rigid areas within. In a preferred embodiment, the compliant band
may be fabricated from fabric webbing material such as nylon
webbing for at least part of its span. Such compliant band may
utilize means for attaching a pad across it, such as a foam pad,
and such means of attachment may utilize VELCRO or other attachment
means. It is understood that such compliant band may not be in one
piece, but may include various pieces to make up such band. Other
sections of such band may include a length adjustability means,
such as but not limited to a ladder strap, which may engage in a
ratchet mechanism.
[0282] Any such ladder strap or cross connector sections may
utilize a connectivity means across their back side, such as but
not limited to VELCRO for example, which may then attach to a pad
to help distribute the forces over a broader surface area.
[0283] Through using a section of the band, which may be
disconnected, such as a ladder strap and ratchet mechanism, such
socket design may be disjoined, allowing it to be opened up. By way
of example, a limb shape is generally round. Socket shapes are
therefore typically generally round to match the underlying limb
shape. By opening up the socket, the socket may be splayed open,
and may generally lay flat. This may allow the user to more
effectively or easily donn such a device.
[0284] Such band may as well connect to other members. For example,
a general medial vertical structural member may be connected to the
band near the tuberosity area and generally run distally from
there. Another medial vertical structural member may be connected
to the band near the anterior aspect of the adductor longus tendon
and generally run distally from there. Such medial vertical members
may be connected together, as well as connected to the lateral
supporting members at some more distal level. The medial vertical
members may help prevent the proximal band from digging into or
roping into the limb, by spreading the forces down the length of
the limb by virtue of its connectivity. In addition, this
compilation helps to control and manage the underlying bone more
effectively.
[0285] In fabricating a conventional socket, great care is taken to
custom tailor the shape of the socket shape for the user. The
socket is typically hand sculpted to match the underlying anatomy,
such as around the adductor longus tendon, around the ramus, at the
distal end to provide space for the distal cut end of the bone, and
around the muscle bellys and soft tissue. Since the human body is
so dynamic, the custom tailored socket will likely no longer fit
appropriately with just a small change in body weight. When a
practitioner needs to make incremental changes to the shape or
contouring of a socket, during the fabrication and fitting
processes, they will likely use a heat gun to modify the
thermoplastic socket, or grind part of the material away of the
socket, or place pads within the socket. Each of these adjustments
is time consuming, is inexact, and is not simple or often not
possible to reverse.
[0286] Similarly, long ago the alignment of a prosthetic was
equally as inexact and challenging, by requiring the socket to be
cut off from the underlying components, repositioned, and bonded
back on in order to make even small alignment changes.
[0287] In years past endoskeletal components were introduced to the
prosthetics field, which use a male pyramid and female receiver to
provide incremental, simple, and reversible adjustments to the
alignment. This addition revolutionized the fitting process of a
prosthetic, as even minor modifications could be done to the
alignment in real-time. Those changes could be reversed. And those
changes could be quantified, and documented.
[0288] In a similar way, the prosthetics field needs a method of
documenting and quantifying the prosthetic socket fit. There is
also a need to allow a practitioner to be able to simply, quickly,
and easily modify the fit in each of the areas of interest in
real-time, to test how a change may feel to the user, and be able
to just as easily reverse that change. Current prosthetic fitting
approaches do not allow for that to take place.
[0289] This disclosure allows for just that to happen. Through the
use of the various cross connectors, adjustment mechanisms, and
swing strap, every aspect of the fit of a prosthetic can now be
adjusted in real-time--all of which are quantifiable, documentable,
and reversible. Such cross connectors, swing strap, and adjustment
mechanisms may be flexible, compliant, soft, or otherwise conform
for the user with varying degrees of flexibility.
[0290] The cross connectors in this design may utilize incremental
adjustment means to alter the distance between their connection
points. In one embodiment, this may be holes in a strap, though
this should not be considered limiting, as there are numerous
embodiments that could accomplish the same.
[0291] Beginning with FIG. 17, the proximal medial connector 1702
connects the two medial floating members 1703. Each floating and
anchor member may utilize methods of attaching cross connectors,
such as incremental holes to provide anchor points, although other
attachment methods are contemplated, and should not be considered
limiting. As this section is tightened, it allows for the proximal
medial swing strap 1704 to have more space, and hence can have
additional room for the adductor longus tendon and related anatomy.
In typical sockets, the socket shape is contoured around the
anatomy as such, and the contouring of this disclosure can highly
resemble a conventional socket contouring, by making this
incremental change to the tightness of the cross connector.
[0292] Cross connector 1705 on the medial distal aspect of the
socket may be used to adjust the angle and span of the two floating
medial members. This may impact the available circumferential
positioning of the medial members as well as the relative and
available positioning for the anchor members.
[0293] The proximal posterior cross connector 1706 may influence
the amount and shape of contouring of the swing strap. It may also
influence the amount of suspension of the swing strap to support
the users, as well as the relative positioning of the posterior
medial floating to the tuberosity area. The distal posterior cross
connect also may have influence on the circumferential positioning
of the medial members as well as the relative and available
positioning for the anchor members.
[0294] Lateral proximal cross connector 1707 may provide added
system rigidity by preventing the anchor members from splaying
apart under load.
[0295] Distal lateral cross connector 1708 may be positioned
proximal to the cut end of the bone, such that a pad may be placed
between it and the user if chosen, and may post the bone. By doing
such, it may control the position of the bone within the socket,
and provide increased bone control and comfort for the user.
[0296] Anterior connectors 1709 may be adjustable, and removable,
such as ladder and ratchet straps. In such an example, incremental
adjustments to the circumferential tightness of the system can be
accomplished.
[0297] Each of the cross connectors, and ladder, may use markings
to show relative positioning, such as numbering their ladder rungs,
or holes within the cross connectors, or other means, so that a
practitioner or user can compare and quantify relative positions,
and document such positions. With so many adjustment means within
the system, a practitioner can custom tailor an entire socket, in
each and every area which a socket needs to be tailored, but in a
quantifiable, documentable, and quickly and easily reversible
manner. This allows a practitioner to test various fitting changes
in real-time.
[0298] If padding is needed, pads may be applied between any such
cross connectors or ladders and the user. Such pads may be attached
in any number of methods known in the industry, including VELCRO or
bonding them.
[0299] In addition, the swing strap 1704 may be attached to its
ends in such a way as to allow for incremental adjustability to
adjust tightness and suspension. Such swing strap may be fabricated
out of any number of materials, but in a preferred embodiment, it
may be fabricated from nylon webbing or the like, which is very
durable, very lightweight, and very flexible. Such swing strap may
incorporate a means for connecting a pad, such as VELCRO. Such pad
may be connected to the swing strap, and provide added cushioning
and comfort to the user, as well as to control and manage tissue.
Any such pads within such a system may be removable for washing,
replacement, or adjustments, such as skiving the pad to a different
shape to accommodate for contouring of the limb or comfort.
[0300] Such swing assembly may be connected to the lateral anchor
members on their proximal ends. In one embodiment, the posterior
aspect of the swing assembly may connect to the posterior lateral
anchor member, and the other end of the swing strap may connect to
the anterior medial floating member. That anterior medial floating
member may then have an adjustable strap connected from it to the
anterior lateral anchor member, providing a complete connection
around the medial aspect of the limb, to both anchor members. By
doing such, the proximal brim may act more like a swing or hammock,
and the anchor members may act like a hammock stand.
[0301] A floating member may utilize a more flexible member 1710
attached to it on the user side of the member, such that the
proximal end of such floating member may have gradual tapering of
relative stiffness, preventing it from digging into the user on its
proximal edge.
[0302] In such configuration of the swing strap and flexible
members, the entire proximal brim may be flexible and compliant,
lacking rigid or hard elements as are found in conventional
prosthetics. Conventional prosthetics all use a rigid shelf to seat
area to sit onto near their tuberosity area, which is uncomfortable
for the user. In this disclosure however, such proximal brim may be
entirely compliant, allowing for there to be no hard shelf, but
rather a brim shape that more resembles a hammock or swing
instead.
[0303] Toward the distal of the medial floating members, at least
one of such members may be modularly connected to the main base,
such as the mounting point where the knee may attach. This may be
accomplished by a dynamic tab, which may allow for infinite
360-degree rotation at its attachment to provide optimal
positioning about the limb. Such dynamic tab may allow for another
connector piece to be attached, such as but not limited to a ladder
strap. Such ladder strap for example, may then connect to a
ratchet, which may be mounted on a medial floating member.
Connecting the two together with a compliant strap such as this
allows for the medial floating members to be pulled distally, which
inherently tightens them against the limb as a 4-bar linkage
operates. This may help to solidify the structure of the socket as
a whole, even though many of the connectors may be quite compliant
and flexible. This unites the socket and the limb into one
functional element, providing a greater one-to-one connection
between the limb and the socket, and hence underlying bone to
socket.
[0304] It is contemplated that similar means may be used for other
limb levels, such as transtibial limbs, and in such examples, the
lateral aspect of the limb may not be the preferred positioning, as
it would be for a transfemoral use-case. Such positioning may be
custom tailored to the prosthetic level, and more specifically to
the users' requirements. In addition, it is contemplated that the
supporting members for a transfemoral design may as well be
positioned in positions other than just the lateral posterior and
lateral anterior aspects of the limb.
[0305] The use of any flexible contoured "socket" about the limb
may be supported by such a system. If such underlying socket were
fabricated from conventional or similar materials, the modularity
of this system may allow for an end user to self-adjust the socket.
Conventional fittings typically use a custom fabricated inner
socket shape to the user. This disclosure certainly could become
the frame around such inner socket shape, allowing for the benefits
of using a conventional inner socket if the practitioner should
choose to use such a device, and take advantage of the
adjustability and simplicity of fitting this design around it.
[0306] To fit such a system to a user, the use of modular
components may be utilized to fine tune the position of supporting
members about the limb. In general, each supporting member(s) 2601
(and by example, one on the lateral posterior aspect of the
residual bone, and one on the lateral anterior aspect of the
residual bone) may be connected to an adaptor 2602 which may
connect it to a modularly adjustable component. By way of example,
such adaptor may be in the form of a through-hole tube clamp type
of adaptor. Such adaptor may connect to the supporting member, and
may connect to a pylon 2603, although other embodiments, and even
more simple embodiments, are certainly contemplated, and such
example should not be considered limiting.
[0307] This configuration may allow for such vertical supporting
member to be adjusted in position up and down with respect to the
body, as well adjusted in rotation so that it may lay flat against
the body.
[0308] Such tube or pylon, which connects proximally to the
through-hole tube clamp adaptor or the like, may then connect
distally to a typical tube clamp or female adaptor 2604, which may
then engage with a male pyramid 2605. Such intersection may allow
for modular adjustability of the angulations of the vertical
supporting member(s).
[0309] Such male pyramid may be connected to a horizontal plate
2607. Such plate may have various possible positions in which the
male pyramid may be mountable, in order to alter the lateral
positioning of the supporting member with respect to the limb. This
may help accommodate for various size limbs.
[0310] As illustrated in FIG. 27, such horizontal plates may be
connected together with through hole bolts, which may connect to a
four-hole plate on the inside of the device, and may connect to a
four-hole male or female pyramid on its distal aspect, which may be
then be connected to a knee or other components.
[0311] If more than one horizontal plate may be used, it may
utilize adjustable means to modularly adjust the position of one
plate with respect to the other. Through such a slot configuration
as is show in the illustrations, 360 degrees of adjustability may
be realized for each plate. It is contemplated that 1, 2, 3, or 4,
or more plates may be utilized within such a system. Such plates
may be marked to quantify their relative positions.
[0312] Such components may be used for in-office fittings, to allow
a practitioner to set the position of the supporting struts to the
user, and establish general alignment of all aspects of the device.
They may also be used for definitive use as needed.
[0313] Various methods of connectivity for any such components are
contemplated, and those described should not be considered
limiting.
[0314] When transferring from the fitting components to a
definitive setup, the fitting components may be placed in a typical
transfer jig in order to capture the alignment and position of the
supporting struts with respect to the underlying component such as
the knee and foot. The struts may be swapped for dummy struts,
which may be used for laminating a distal socket, and replacing
with the actual struts after the lamination, or the like, is
fabricated.
[0315] Alternatively, a modular adjustor mechanism may be used to
connect the supporting members to the distal end. While there are
various embodiments that may be utilized to connect the supporting
struts to where the knee or distal components connect, the example
of a preferred embodiment as described below captures various
preferred characteristics of such a system, including simple
modularity, cost effective, and low profile design.
[0316] In a preferred embodiment, such components may allow for
infinite adjustability to custom tailor the connectivity position
to the user, so that a select few components may be used for many
different configurations. Simultaneously, such components should be
able to remain very low profile and contoured about the residual
limb whereas to not result in a bulky socket.
[0317] In one embodiment, as generally illustrated in FIG. 28, such
distal attachment plate may be formable, such as but not limited to
thermoformable, so that after use of it with the other fitting
components to establish proper alignment and positions, in a
transfer, its lateral end could be heated, for example, and bent
into position, creating a bent structural supporting member to
connect the knee attachment area to the strut.
[0318] Alternatively, such distal attachment plate may be cut to
length, and a secondary curved member may be attached, which may or
may not be thermoformable, to allow for connection between the
distal end knee attachment area to the supporting members.
[0319] Any such component of the fitting system may utilize
branding on it, including the proximal four-hole attachment
plate.
[0320] Transhumeral Socket
[0321] In a similar method as described for transfemoral
applications, a similar set of components may be used to fit other
levels of amputations. For example, in a transhumeral fitting, a
supporting member may be used which generally may have a distal
attachment plate to mount to components such as a prosthetic elbow.
Such plate may be near 90 degrees to the long section of such
member, which may generally run along the length of the residual
limb, toward the axilla, though may be located on either side of
the limb. Attached to at least one supporting member may be at
least one floating members. Such floating members may functionally
act similar to the floating medial members of the transfemoral
use-case example as described previously. Such floating members may
generally reside on the medial aspect of the arm, and/or may reside
just lateral to the biceps and/or in between the two heads of the
triceps. All three (for example) members may be joined with
compliant connectors. Such compliant members may be similar to
those of the transfemoral fitting level, although their
characteristics may be slightly modified such as in flexibility,
method of adjustability, or width, or others. Disconnectable
adjustors may be utilized to allow the system to splay open. Such
adjustors or connectors may be able to be adjusted in position or
tightness, allowing the user to self-tighten their fit. Such
connectors may encircle the limb, connecting all floating and
supporting members together around a limb. Each of such members may
have means for connecting a pad within, and may additionally
utilize connectivity means to an underlying liner or sock, as
described in the transfemoral section, including, but not limited
to VELCRO.
[0322] Similar to the dynamic tab as described in the transfemoral
socket example, the floating members may be connected to either the
distal end of the main support member to provide the 4-bar linkage
effect to lock the socket about the body more effectively.
Alternatively, the floating members may be connected to the
harness, such as vest harness (MartinBionics) design, and such
connectivity force may accomplish the same. Or a combination of the
two may be used.
[0323] For upper extremity users, the use of a sock or liner to
control and manage the residual limb tissue can still be quite
valuable, and can be used to further distribute the forces over a
broader surface area, and provide suspension capabilities. Using
VELCRO, for instance, to connect a liner to the pads of the
floating or support members can be an effective way to achieve
suspension.
[0324] Similar to that described in the transfemoral level fitting,
cross connectors, adjustable connectors, and other such elements
may be incorporated within, to allow for quick and easy modular
adjustability of the fit in every area of the socket where a
practitioner may typically fit the prosthetic to the user through
conventional tailoring methods.
[0325] The proximal medial aspect of the socket may utilize a
floating brim design, and in a preferred embodiment may be made of
comfortable materials such as fabric and/or foam, by way of
example. Other materials may be used as well. Such floating brim
may be connected to anchored and/or floating struts, and may be
adjustable in length. Such floating brim may provide accommodation
to the dynamic nature of the axilla area, and provide additional
comfort. Such brim may functionally be similar to the medial brim
of the transfemoral application socket.
[0326] FIGS. 29A-29E generally illustrate various embodiments of
how such a socket may engage around a residual limb at the
transhumeral level. Similar means may be used as described in the
transfemoral level, though specific to the anatomy of this limb
segment.
[0327] Transradial Socket
[0328] Likewise, a similar method may be used to connect such a
device for a transradial limb. In such an example, at least one
supporting member may be applied along the anterior or posterior
aspect of the lower arm (front or back of forearm), as in the
position on an anatomical chart. Such floating member(s) may run
along opposing sides of the arm. All such members may be connected
together with compliant connectors, and at least some of such
connectors may be quickly and easily adjustable, and may be able to
be splayed open, versus remaining as a socket, which by definition
is a natural or artificial hollow into which something fits. It is
contemplated that other configurations may be utilized to
accomplish the same.
[0329] The use of such an open socket, versus a traditional
encapsulated socket, inherently allows for the system to not trap
as much heat, be considerably cooler, lighter, more breathable, and
allow for simpler and more effective connectivity of EMG controls
or other such sensors.
[0330] Similar to the transfemoral use-case example, the proximal
anterior (front side of arm in the anatomical position) aspect of
the socket may utilize a floating brim, which may be made of
comfortable materials such as but not limited to fabric, webbing,
foam padding, or others. As the elbow may flex, the comfortable
materials may match to the underlying dynamic body, providing
additional comfort. Such brim may be connected to floating member,
anchor members, or a combination of both. It may also be
adjustable, allowing the socket to be tightened to user
preference.
[0331] Through allowing a supporting member to be attached to
floating member(s) provides an opportunity that conventional socket
designs cannot. For instance, VELCRO, or other textured materials,
would be impractical for an amputee to use in a conventional socket
for suspension, as there would not be a way of releasing it since a
hollow socket cannot open up. But since this/these designs can be
splayed open through the use of the floating struts, such a system
can utilize VELCRO, or other such connectivity means, and the user
can still doff the device when needed with ease, yet have
incredible suspension capabilities when the socket is donned.
[0332] For any such fitting level application, a conventional
socket, or a portion of a conventional socket may be attached
within the system to utilize benefits of conventional socket
fitting or suspension methods within such a system. Such a socket
may be connected to the supporting members, the floating members,
or a combination of both. Likewise, it may not be connected to
either, and only be connected to the distal end.
[0333] FIGS. 30A-30E generally illustrate various embodiments of
how such a socket may engage around a residual limb at the
transradial level. Similar means may be used as described in the
transfemoral level, though specific to the anatomy of this limb
segment.
[0334] Transtibial Application
[0335] Transtibial use-cases may be highly similar to the
transfemoral application in many ways, though with slightly
different configurations of similar components. For a transtibial
application, supporting member(s) may be used on the anterior,
lateral, medial, and/or posterior sides, although in a preferred
embodiment they may be located at least on the anterior side. There
may be at least one such supporting member, and in a preferred
embodiment perhaps two.
[0336] In one embodiment, a supporting member may run along the
anterior lateral aspect of the tibia bone, while another supporting
member may run along the medial aspect of the tibia bone. Floating
member(s) may be used along the posterior aspect of the limb, such
as up the middle or sides of the gastrocs muscle belly.
[0337] Alternatively, supporting member(s) may be used along just
the medial aspect of the tibia for instance, with floating members
along the anterior lateral aspect of the tibia, and/or along the
posterior aspect of the limb.
[0338] Alternatively, a supporting member may run along the
posterior aspect of the limb, with floating members along the
anterior lateral and anterior medial aspects of the tibia.
[0339] In any such configuration, similar connector means and
self-tightening means may be used to connect supporting and
floating members together around such a limb, as has been described
in the transfemoral configuration example. In addition, such system
may also utilize pads, dynamic tabs, and other such components of a
transfemoral system, but configured specifically to the transtibial
level.
[0340] Spanning within and between such anchor and floating members
may be various configurations of pads, which may be used to contain
and control tissue management within such a socket. Such pads may
or may not be connected together distally.
[0341] At the distal end of the socket may be an attachment point
for modular components such as pylons or feet, as would be
typically found in such applications.
[0342] In one embodiment, the posterior proximal aspect of the
socket may utilize a floating brim, which may be made of
conformable materials such as but not limited to fabric, webbing,
foam, or others, by way of example.
[0343] Further, since such a socket may be able to splay open, it
may accommodate for volumetric change by tightening up or loosening
the circumferential dimension of the socket, by way of
adjustability means as illustrated in the figures.
[0344] Any such sockets may utilize areas of custom molded
contouring about the limb shape, in additional to purely modular
areas of conformity. For instance, custom molded areas around the
tibial and femoral condyles may be accomplished through custom
molded areas as in conventional fitting methods, which may attach
to the modular areas, or such area may utilize off-the-shelf
section that may then be customized to fit the user.
[0345] FIGS. 31A-31G generally illustrate various embodiments of
how such a socket may engage around a residual limb at the
transtibial level. Similar means may be used as described in the
transfemoral level, though specific to the anatomy of this limb
segment.
[0346] Liner Suspension
[0347] In conventional prosthetics, gel liners are used to provide
cushioning for amputees, within rigid sockets. With this
disclosure, there may not be a rigid socket, and hence the
requirements for and advantages of a gel liner may be distinctly
different. In conventional sockets, there is vacuum that is created
between a liner and an encapsulated socket to help hold the
prosthetic in place. A seal is formed between the limb and socket
or liner and socket to achieve such suspension. In this disclosure,
a gel liner or air impervious liner may be used to suspend the
prosthetic, by attaching it directly to the prosthetic with
mechanical means, or other. For instance, and by way of example, a
gel liner with loop VELCRO on its outer covering may be
mechanically connected to VELCRO hook, which may reside on the
inner surface of anchor or floating members of this disclosure.
Because this disclosure offers a device that can be effectively
unwrapped from around a limb, versus a traditional bucket socket,
the VELCRO may be used to mechanically connect such VELCROs
together, maintaining suspension. Because the gel liner may not
allow air to enter, it may effectively be held onto the limb with
suction, negative pressure, or vacuum.
[0348] Attaching a liner in removable manner, as generally
illustrated in FIG. 32, to a strut type of design directly, for
suspension, is unique for use in prosthetics, as no other strut
type of designs used in prosthetics utilize a removable
connectivity between the two for suspension.
[0349] Swing Brim
[0350] Users of conventional prosthetic sockets often experience
discomfort in areas such as the proximal brim, such as the ischial
tuberosity, ramus, and general proximal medial, anterior, and
posterior aspects of a conventional socket. In such conventional
sockets, the dynamic limb is encapsulated within a static socket
shape, which results in rubbing, chafing, and pressure in these
unwanted areas.
[0351] It has been discovered through the use of compliant brim
designs, such as those disclosed in this application and its
priority applications, that the user can remain significantly more
comfortable if the brim materials can conform to the user, versus
the user having to conform to the brim. As such, the incorporation
of the disclosed brim design within a conventional prosthetic
socket can significantly increase the comfort of the conventional
socket.
[0352] To accomplish such, various fabrication integration options
may be used, and those described below should not be considered
limiting, but rather are for examples of various options. It is
understood that various other options, including various trim line
options and attachment options may be used.
[0353] In a preferred embodiment, the swing webbing may incorporate
contouring such that it may assist in laying at the correct angle
and orientation around the underlying anatomy as it wraps around
the limb. In one such example, an illustration can be found in FIG.
33 showing one such configuration. In a preferred embodiment, one
side of such webbing material may be VELCRO compatible, or other
attachment methods, allowing for padding to be attached to it,
which may help further spread forces and add comfort.
[0354] The ends of such swing webbing may attach to the frame or
struts with conventional attachment means, which may include,
buckles, rivets, screws, sewn in place, or the like. Such
attachment means may be adjustable or non-adjustable as the
practitioner deems necessary or preferable.
[0355] Option 1 as illustrated in FIGS. 34A (lateral view), 34B
(posterior view), 34C (medial view), and 34D (anterior view):
Conventional flexible inner socket with Socket-less Socket Swing
Webbing and frame. Inner socket may or may not be trimmed down.
[0356] A conventional flexible inner socket may be removed from a
conventional frame, and replaced with a Socket-less Socket frame
structure around the conventional inner socket. Doing so may
eliminate the rigid ischial seat, as it would be replaced by the
swing webbing, which may generally span from around the lateral
posterior strut, connect to the posterior medial strut, and span
anterior toward the anterior medial strut and anterior lateral
strut, forming a swing shape, with the two lateral struts as the
hammock stand.
[0357] Since the medial struts may generally float with respect to
the distal mounting method, and hence not have a rigid structure
underneath, the medial brim of the socket may generally offer
greater compliance, and more comfort. The socket-less socket frame
around a conventional inner socket may also offer greater
adjustability, by allowing for ratchet or similar adjustment means
to tighten the span between various struts, causing the flexible
inner socket to become tighter around the limb.
[0358] This may also expedite the fitting and fabrication process
over conventional means, as well as create a more modular fitting
method.
[0359] If the flexible inner socket is trimmed down from its
original shape, the advantage of the swing webbing with integrated
padding may be used to replace a portion of the brim of the
conventional socket. For instance, the posterior and medial aspects
of the conventional brim are typically uncomfortable in sitting and
standing. Trimming these areas lower and replacing them with
padding over the compliant swing webbing may allow for greater
conformity and comfort.
[0360] Specific areas that stand to benefit from adjustments
include:
[0361] Posterior brim: This area is often bulky in sitting on a
chair, and uncomfortable in sitting. Lowering this area and
replacing it with webbing provides a lower profile build height,
and hence more comfort.
[0362] Medial brim: This area is especially uncomfortable in
conventional sockets, as the medial brim typically uses a rigid
ischial seat, and static ramus shape. Much of the discomfort
experienced in conventional sockets is in this area. Replacing the
brim with conforming webbing material for instance, allows it to
conform to the user, versus the user conforming to the static brim
shape.
[0363] Anterior brim: This area is often uncomfortable in sitting,
as it presses into the abdomen during hip flexion. In conventional
sockets, this area posts off the abdomen, and can cause a loss of
suction in sitting activities. By replacing this area with flexible
conforming fabrics as a brim material, it no longer posts against
the abdomen, allowing for better retention of suspension and
comfort.
[0364] If the conventional inner socket is trimmed down, it may be
trimmed in any or all of the above mentioned areas, including as
well the lateral side. This may functionally allow for the inner
socket to function much like a traditional socket-less socket
fitting, but utilize and existing flexible inner socket. If the
conventional inner socket remains intact in part or in its
entirety, the comfort may still be greater by eliminating a rigid
ischial seat, and allowing the brim in general to have more
conformity than a conventional frame surrounding it.
[0365] While there may be more conformity, the swing brim may
simultaneously capture and control the tissue, and prevent
ballooning of the tissue in this area, as well as cold creep of the
plastic, since it will be supporting the underlying flexible inner
socket with a non-stretch material.
[0366] Option 2 as illustrated in FIGS. 35A (lateral view of
conventional inner socket trimlines compared to Swing Brim
trimlines), 35B (posterior view of conventional inner socket
trimlines compared to Swing Brim trimlines), 35C (medial view of
conventional inner socket trimlines compared to Swing Brim
trimlines), 35D (anterior view of conventional inner socket
trimlines compared to Swing Brim trimlines), 36A (lateral view of
conventional frame trimlines compared to Swing Brim use trimlines),
36B (posterior view of conventional frame trimlines compared to
Swing Brim use trimlines), 36C (medial view of conventional frame
trimlines compared to Swing Brim use trimlines), 36D (anterior view
of conventional frame trimlines compared to Swing Brim use
trimlines), and 37A, 37B, 37C, and 37D of integrated Swing Brim on
a conventional socket: Conventional flexible inner socket and frame
with modified trimlines of both, to incorporate and replace the use
of the a Swing Brim instead of static brim plastics.
[0367] Similar to option 1 above, remaining with a conventional
socket AND frame, both with modified trim lines, may allow the brim
of the socket to benefit from a more comfortable compliant swing
webbing, while maintaining a consistent fit within the remainder of
the socket.
[0368] To accomplish such, the posterior, medial, and/or anterior
brim of the conventional flexible inner socket and its surrounding
frame can be trimmed down in various amounts as needed or desired,
allowing the limb and tissue to be encapsulated by the swing
webbing and padding instead of the conventional more rigid
materials.
[0369] The swing webbing may be attached to the lateral posterior
and lateral anterior frame areas, in similar positions as may be
used with a socket-less socket frame configuration.
[0370] The contouring of the conventional flexible inner socket
trim lines may as well utilize areas to resemble the strutserts of
a socket-less socket configuration. As such, the flexible inner
socket may extend upward near where the medial posterior and medial
anterior struts may reside, and allow the swing webbing to attach
to the flexible inner socket extension areas. Likewise, between any
of the various areas of the swing webbing, but preferably in the
anterior section, the swing may be adjustable, allowing for the
user to tighten or loosen the fit of the swing brim.
[0371] Referring to FIGS. 26A-26B, such fitting components may
utilize a method of determining the relational position of various
fitting components with respect to others, including angles,
positions, rotation, and height amongst others. Such method of
determining relative positions may be used to determine the final
alignment of the device, and used for definitive stage
transferring. For instance, the position of the laminating plate
(or its equivalent) with respect to the two through hold tube
clamps which anchor to the two lateral struts may be used to
determine how the final assembly is fabricated. Knowing those
positions with respect to each other may enable one to fabricate a
definitive lamination for instance, without having to have the
specific components in hand, such as if a central fabrication
facility may be doing the fabrication work.
[0372] In such an example, this may be accomplished through
electronic means, with marks, or the like, on the fitting
components to determine relative positions, or other such means. In
any example, the method should provide a quantifiable determination
of the angular, rotational, positional, or other orientation of the
device.
[0373] Using modular elements to assemble a socket about a user's
limb allows for various configuration options to be quantifiable,
recordable, and repeatable. Specific elements of the modular
assembly may further have noted configuration options, such as but
not limited to, numbering various holes or mounting locations.
[0374] FIG. 38 generally illustrates an embodiment of an
illustration which mounting holes in various sub-components may be
defined in order to quantify a particular configuration.
[0375] By way of example, the fifth hole down from the top in the
posterior lateral strut may connect with the adjoining cross
connector in its hole number 0. All elements of an entire socket
assembly configuration may be defined with such a method.
Additionally, there are general trends, which may be relatively
common amongst various fittings and configurations. One such
example may be that the top hole in the posterior lateral strut may
generally connect with the swing webbing at that location. Trends
also may occur when comparing limb size and shape with which
connection points intersect. For instance, a limb that is large in
circumference may generally have a longer span between the various
struts through the cross connectors. Likewise, a limb that is
smaller in circumference may generally have a shorter span between
the various struts through the cross connectors. Similar trends may
occur with respect to limb length and mounting locations of the
distal band of connectors.
[0376] Because of the inherent trends, an algorithm may be used to
correlate the defined configuration assembly to a limb
circumference and/or length. Through using mathematical modeling,
correlation algorithms, look up tables, artificial intelligence
programs, or common sense, amongst other possible methods, a user
may be able to input limb measurements and create an output
assembly configuration suitable for such a limb size and shape,
without a need to directly fit the device to the user to establish
the same.
[0377] Such limb measurements may include, but not be limited to,
proximal circumference, distal circumference, limb length from one
or more of various relative distances along the limb, patient
weight, scan of a limb, digitizing of a limb, tape measurements of
a limb, or any other physical or electronic means of capturing limb
size, shape, volume, soft tissue and skeletal anatomy, or other
parameters.
[0378] The output of such a method may be at least one of any
commonly used to illustrate data, but may include methods such as
an App, Software, computer generated output, computer generated
illustration, illustration, picture, virtual reality, or know-how,
amongst others.
[0379] In one embodiment, in the case of utilizing an App or
Software, FIGS. 39A-39C generally illustrate a possible work flow
of how a user may input variables into such system, and result in
an output.
[0380] Such as system may as well be used for: ordering a device in
a particular assembly configuration based on measurements, used for
assembling a device in a particular configuration based on
measurements, defining additional sub-components desired in a
particular configuration, storing of user data or patient specific
data, documentation of user data or patient specific data, tracking
utilization of device, or other related information.
[0381] Upon actual assembly of such a device, based on
measurements, an actual fitting on an end user may occur, and such
a device may be further customized to fit to the actual user.
[0382] Final fitting configurations, which may account for later
fitting adjustments that may be made on an actual user, may be
input to such a system, and used for improving such algorithms.
Self-learning algorithms, modified algorithms, or other methods may
be used to continue to refine the accuracy of the
measurement-defined assembly configuration to that of an actual
fitting configuration on an actual end user.
[0383] Such a method may be used on any level of amputation, or
fitting of any level or type of orthotic device through such a
system.
[0384] In one embodiment illustrated in FIGS. 40A, 40B, and 40C,
and similar to FIG. 1C, stabilizing unit 102 may generally be
positioned near the adductor muscle group, and may generally
contour over, in between, or near the hamstrings and adductor
muscle groups. Stabilizing unit 102B may generally be positioned on
the lateral aspect of the limb, and more specifically may be
positioned along the posterior lateral aspect of the limb, and more
specifically may be positioned between the hamstrings and lateral
quadriceps in some configurations.
[0385] The proximal brim may utilize a generally compliant member
or structure 200 to span between the stabilizing units 102 and
102B. The limb may generally be supported through these compliant
members across the brim area of the socket, including medially and
posteriorly. The anterior area of the brim may also use compliant
materials to span there between, and more particularly may use an
adjustable member 4002A along with in such area.
[0386] Between the two stabilizing units described, a floating
member 4001 may be integrated, which may be used to capture and
control the limb within the socket configuration. For example, such
floating member may generally be positioned to sit just anterior to
the distal cut end of the bone. Likewise, at least one of the
stabilizing unit members may generally be positioned just posterior
to the cut end of the bone. Or alternatively, such anchored and
floating members may generally be positioned on either side of the
such bone, whether anterior/posterior, posterior/anterior,
medial/lateral, or other such combinations.
[0387] Through integrating such floating member 4001, and through
adding an adjustability means or circumferential connector 4002B
and or 4005, the floating member may be user-adjusted to capture
and control the limb within the socket interior 4006.
[0388] Such floating member may be relatively short, or may be long
in length. It may be connected just to the other anchored
stabilizing unit members circumferentially, or may also be
connected to the brim area proximally, or may also be connected
distally to other compliant members. In a preferred embodiment
though, the floating member may not be connected rigidly, but
rather through "floating" it between rigid members through
compliant materials may allow the floating member to be effectively
wrapped around the limb and contour to match the underlying limb
shape.
[0389] Such floating member may be specifically contoured to match
the underlying anatomy, or may be a pre-determined shape. A pad may
also be attached on its inside to allow it to press against the
limb with more specific contouring.
[0390] On the posterior/medial side of the system, another floating
member 4003 may be positioned generally near or in between the
hamstrings and adductor muscle groups. Such floating member may
also be connected through compliant materials 4004 to other members
such as the brim area of compliant member or structure 200.
[0391] The floating members may use a material, which generally can
hold its form, but may be relatively flexible or rigid in nature.
As the circumferential connectors 4005 and 4002B are tightened
around the limb, the floating member may generally press against
the underlying limb and help prevent the circumferential connectors
from roping into the limb tissue.
[0392] In one embodiment, a compliant connector may provide a
common mounting connector for various stabilizing members and
floating members, providing a visual `distal end` to the socket. In
such a configuration, the socket may offer a low profile cosmetic
appearance about the underlying limb, by effectively eliminating
any potential socket bulk along the anterior/lateral aspects of the
socket. Through positioning the anchored stabilizing unit members
as positionally opposing each other, the socket can also achieve a
narrower medial/lateral dimension, thus more effectively capturing
the underlying bony anatomy and provide greater control within the
device.
[0393] The invention therefor contemplates a transfemoral level
prosthetic socket apparatus for attaching a prosthetic to a limb of
a user comprising: a first stabilizer unit having a first proximal
end and a first distal end first end and adapted to be
perpendicularly positioned near an adductor muscle group of said
user; a second stabilizer unit having a second proximal end and a
second distal end and adapted to be perpendicularly positioned
between a hamstring and a lateral quadriceps of said user; a
proximal brim made of a complaint material spanning from said first
proximal end of said first stabilizer to said second proximal end
of said second stabilizer and adapted to support said limb; a first
adjustable member having a length located opposite of said proximal
brim and spanning from said first proximal end of said first
stabilizer to said second proximal end of said second stabilizer
wherein said length is adjustable; a floating member having a third
proximal end and a third distal end perpendicularly positioned
between said first stabilizer and said second stabilizer opposite
and below said proximal brim and adapted capture and control said
limb within said socket; and a second adjustable member having a
first end attached to said first stabilizer, a second end attached
to said second stabilizer, and a length attached to said floating
member wherein said second adjustable member is adapted to be
adjustable in length.
[0394] It is further understood that the use of such a system has
the potential to functionally eliminate the need for expensive
machinery commonly used to fabricate conventional prosthetics, and
reduce the toolset down to simple hand tools such as Allen wrenches
for example. Furthermore, the use of such a system has the
potential to functionally eliminate the need for a highly trained
and skilled clinician to fit a prosthetic socket for instance, as
much or all of a defined and successful fit may be defined through
an algorithm, or the like.
* * * * *