U.S. patent application number 16/105851 was filed with the patent office on 2019-06-06 for orthotic or prosthetic cushioned device and method of making the same.
This patent application is currently assigned to Materialise, NV. The applicant listed for this patent is Jari Heikki Petteri PALLARI. Invention is credited to Jari Heikki Petteri PALLARI.
Application Number | 20190167450 16/105851 |
Document ID | / |
Family ID | 40325922 |
Filed Date | 2019-06-06 |
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United States Patent
Application |
20190167450 |
Kind Code |
A1 |
PALLARI; Jari Heikki
Petteri |
June 6, 2019 |
ORTHOTIC OR PROSTHETIC CUSHIONED DEVICE AND METHOD OF MAKING THE
SAME
Abstract
Orthotic and prosthetic devices having integrated features such
as cushioning features are described, as well as methods for
computer aided designing and making of these devices. The orthotic
or prosthetic devices comprise a cushioning layer superimposed onto
an orthotic or prosthetic shell, the cushioning layer comprising an
array (35) of discrete solid and resilient cushioning elements
(31). In one preferred embodiment, said cushioning structure is a
beam, defined around a centerline of any arbitrary shape. In
another preferred embodiment, said cushioning structure has the
shape of a spiral.
Inventors: |
PALLARI; Jari Heikki Petteri;
(Leuven, BE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
PALLARI; Jari Heikki Petteri |
Leuven |
|
BE |
|
|
Assignee: |
Materialise, NV
Leuven
BE
|
Family ID: |
40325922 |
Appl. No.: |
16/105851 |
Filed: |
August 20, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
12636219 |
Dec 11, 2009 |
10052217 |
|
|
16105851 |
|
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A43B 13/183 20130101;
A61F 2002/5056 20130101; A61F 2/7812 20130101; A41D 13/0156
20130101; A61F 2002/5075 20130101; A42B 3/124 20130101; A61F
2002/785 20130101; A61F 2/5046 20130101; A61F 2002/503 20130101;
A61F 2002/5049 20130101; A61F 2002/5073 20130101; A61F 2002/5076
20130101; A43B 13/182 20130101; A61F 2002/5079 20130101; A61F
2005/0197 20130101; A61F 2002/505 20130101 |
International
Class: |
A61F 2/78 20060101
A61F002/78; A43B 13/18 20060101 A43B013/18; A61F 2/50 20060101
A61F002/50; A42B 3/12 20060101 A42B003/12; A41D 13/015 20060101
A41D013/015 |
Foreign Application Data
Date |
Code |
Application Number |
Dec 11, 2008 |
GB |
0822590.6 |
Claims
1-20. (canceled)
21. An orthotic or prosthetic device comprising: a plurality of
orthotic or prosthetic shells and a plurality of cushioning layers
forming a sandwich structure, the plurality of cushioning layers
comprising one or more cushioning elements that are homogenously
formed with the plurality of orthotic or prosthetic shells, wherein
at least one of the cushioning elements comprises a first side and
a second side opposite the first side, wherein the first side is
superimposed onto a first shell of the plurality of orthotic or
prosthetic shells and wherein the second side is superimposed onto
a second shell of the plurality of orthotic or prosthetic shells
that is different from the first shell.
22. The orthotic or prosthetic device of claim 21, wherein the at
least one of the cushioning elements comprises a beam.
23. The orthotic or prosthetic device of claim 22, wherein the beam
is wider in a first direction than in a second direction.
24. The orthotic or prosthetic device of claim 21, wherein the one
or more cushioning elements and said plurality of orthotic or
prosthetic shells are formed from the same material.
25. The orthotic or prosthetic device of claim 21, wherein the at
least one of the cushioning elements comprises a spiral.
26. The orthotic or prosthetic device of claim 21, wherein the at
least one of the cushioning elements comprises a rectangular
shape.
27. The orthotic or prosthetic device of claim 21, wherein said
plurality of cushioning layers comprise a plurality of different
types of cushioning elements.
28. The orthotic or prosthetic device of claim 21, wherein at least
one of the plurality of cushioning layers comprises a first
cushioning area having first cushioning properties and a second
cushioning area having second cushioning properties different from
the first cushioning properties for adapting the orthotic or
prosthetic device to a patient.
29. The orthotic or prosthetic device of claim 21, wherein the at
least one of the cushioning elements protrudes from at least one of
the first shell or the second shell at an angle.
30. The orthotic or prosthetic device of claim 29, wherein the
angle is less than 90.degree..
31. The orthotic or prosthetic device of claim 21, wherein the at
least one of the cushioning elements comprises folds configured to
deform when absorbing forces.
32. The orthotic or prosthetic device of claim 21, wherein the
sandwich structure forms a hollow volume with the one or more
cushioning elements inside.
33. The orthotic or prosthetic device of claim 21, further
comprising at least one second cushioning element having a first
side that is superimposed onto at least one of the first shell, the
second shell, or a third shell of the plurality of orthotic or
prosthetic shells and a second side for contacting a part of at
least one of a user or an item directly contacting the user.
34. A device configured to be worn by a user, comprising: a body
arranged to spread pressure between a body part of the user and the
device; and a plurality of orthotic or prosthetic shells and a
plurality of cushioning layers forming a sandwich structure, the
plurality of cushioning layers comprising one or more cushioning
elements that are homogenously formed with the plurality of
orthotic or prosthetic shells, wherein at least one of the
cushioning elements comprises a first side and a second side
opposite the first side, wherein the first side is superimposed
onto a first shell of the plurality of orthotic or prosthetic
shells and wherein the second side is superimposed onto a second
shell of the plurality of orthotic or prosthetic shells that is
different from the first shell.
35. The device of claim 34, wherein the at least one of the
cushioning elements comprises a beam.
36. The device of claim 35, wherein the beam is wider in a first
direction than in a second direction.
37. The device of claim 34, wherein the one or more cushioning
elements and said plurality of orthotic or prosthetic shells are
formed from the same material.
38. The device of claim 34, wherein the at least one of the
cushioning elements comprises a spiral.
39. The device of claim 34, wherein the at least one of the
cushioning elements comprises a rectangular shape.
40. The device of claim 34, wherein said plurality of cushioning
layers comprise a plurality of different types of cushioning
elements.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority from British Patent
Application No. GB 0822590.6, filed Dec. 11, 2008, which is hereby
incorporated by reference.
FIELD OF THE INVENTION
[0002] The present invention relates generally to the field of
orthotic and prosthetic devices and, more specifically, to orthotic
and prosthetic devices having cushioning structures as well as
methods for computer aided designing and making of these
devices.
BACKGROUND TO THE INVENTION
[0003] An orthosis is an external insert, device, support or brace
designed to support a patient in carrying the loads applied onto
them by walking, running, manipulating objects and/or similar
activities and/or by repositioning a limb or forcing them to move a
certain way. They can also spread the pressure between the body and
the shoe/ground/prosthetic over a larger surface area and provide
cushioning to the loaded areas.
[0004] A prosthetic device is an artificial extension of the human
body or a replacement of a lost body part, e.g. to replace a lost
limb or any other body part. A prosthetic limb--upper or lower
extremity--usually consists of a prosthetic socket which conforms
to the residual limb, the artificial limb, such as a hand or leg
and some means of attaching the limb to the socket.
[0005] Currently the design and manufacture of customized orthoses
and prosthetic sockets is a multi-stage and labour intensive
process with significant elements of clinical judgement,
manufacturing craftsmanship and trial-and-error experimentation.
Only a few standardized procedures exist in their design and
manufacturing. This can lead to variation in the final product. The
lengthy manufacturing process can also delay treatment.
[0006] Traditionally the orthoses and prosthetic manufacturing
processes are very similar. Initially, a plaster cast of the
relevant parts of the limb or residual limb is taken; this is then
worked into a positive of the limb/residual limb, where certain
interventions are applied by the craftsman manually. The modified
positive is then vacuum formed or laminated using thermo-formable
plastic. This device is then further modified, finished and fitted
to the patient. Further manual modifications may be necessary,
especially with prosthetic sockets, or when adding hinges to
orthoses. Adding cushioning materials is also one step in the
finishing procedure.
[0007] This process is completely manual, requiring considerable
experience and skill. Each device is also unique, as the work
stages are done slightly differently each time. Also, if several
persons are working on the same device, each person has a different
idea what is required.
[0008] In U.S. Pat. No. 6,968,246, a computer assisted system is
described to address these issues. In the computer assisted
approach, the technician manufacturing the orthoses or prosthesis
can input the shape of the limb/residual limb in question into a
computer system with the aid of a mechanical or a magnetic
digitizer or a 3D laser scanner. This shape is then used to design
an orthoses or prosthesis in specialist computer software that
decreases the overall volume of the device by certain amounts. A
pattern matching this shape can then be manufactured by using a 3D
carver and vacuum molded or laminated as in the traditional
process.
[0009] It is also known from the prior art, as described in the
article in Volume 55(2) (2008) of the IEEE Transactions on
Biomedical Engineering to Faustini entitled "Manufacture of passive
dynamic ankle-foot orthoses using selective laser sintering.", that
customized orthotic or prosthetic devices may be manufactured using
Selective Laser Sintering (SLS), a Rapid Prototyping and
Manufacturing (RP&M) technique, where RP&M can be defined
as a group of techniques used to quickly fabricate a scale model of
an object typically using 3-D computer aided design (CAD) data of
the object.
[0010] Cushioning is applied to these devices by using different
materials attached on the main body of the device. The properties
of the cushioning (e.g. varying from soft to hard) can be adjusted
only by changing the material or the thickness of the cushioning
element, which usually changes the shape of the surface. The
cushioning material and thickness is typically homogeneous over the
pressure carrying area. Local modifications, like local cushions
such as metatarsal pads or bars, cutouts for the plantar fascia,
etc. can be made manually by cutting out material or adding more of
the same or a different material on top of the existing one to
treat certain conditions. The purpose of cushioning is to absorb
the forces placed on it through compression or elastic or plastic
deformation of the cushioning material so that the user of the
device with the cushioning will not have to absorb as much of the
forces.
[0011] However, the need for time-consuming manual tasks makes the
overall process slow and specialist equipment and supplies are
needed. If the design is incorrect, the whole process has to be
restarted. Moreover, the manual process of locating added
cushioning features may result in problems with quality and
consistency as every craftsman works slightly differently and
creates different orthoses. The computer assisted process may
alleviate some of these issues related in creating the positive and
making the interventions to it, but adds more process steps in the
orthoses creation chain and adds extra investment in training,
equipment, milling materials--which also create a lot of
waste--without solving the problems with traditional manufacturing
completely. The lamination/vacuum forming will still have to be
done manually, as will the addition of features such as cushioning,
hinges, cutouts, etc.
[0012] Patent application WO 97/03626 describes a modular interface
connector for a prosthetic limb. The modular interface connector
includes an interface cushion having a feathered periphery of
tapered blades, which conforms to the inner surface of the socket
of the residual limb.
[0013] The paper by Bill Rogers and others, "Case Report: Variably
Compliant Transtibial Prosthetic Socket Fabricated Using Solid
Freeform Fabrication", Journal of Prosthetics and Orthothotics,
2008; 20:1-7, describes sockets fabricated using selective laser
sintering, wherein compliance is provided by a diaphragm spring
that is integrated into the socket wall.
[0014] In the article "Design and freeform fabrication of compliant
cellular materials with graded stiffness" in the Rapid Prototyping
Journal, Vol. 13, No. 4, pp. 213-225, 2007, layer manufactured
cushioning structures for prosthetic applications are described as
solid base material arranged in cellular topologies that permit
high levels of elastic deformation. The structures presented in
this article may solve some of the problems found in prior art, but
they do not offer al the advantages of the present invention.
SUMMARY OF THE INVENTION
[0015] Accordingly, those skilled in the art of orthotic and
prosthetic device manufacturing and the like recognize the need for
integrated features such as cushioning features as well as suitable
manufacturing methods for orthoses and prosthesis enabling at least
some of the advantages of the prior art procedures, yet having less
limitations associated therewith. The cushioning properties of a
cushioning structure refer to it being compressibly resilient. This
can mean the compressibility of the material, the elastic
deformation of the structure or a combination thereof. This can be
measured for example with the standard ISO 7619 or ASTM D2240. The
areas of the orthotic/prosthetic device that are cushioned using
the embodiments described in this invention have the Shore value of
20-90 when measured using an 00 durometer using these standards.
This cushioning structure is not foam. Each shape and feature in
the cushioning structure is determined deliberately either by the
user or the computer system. Shapes and features in the cushioning
structure can be seamlessly adjusted as needed by the computer
system or the user.
[0016] The present invention provides orthotic and prosthetic
devices having integrated features such as cushioning features, as
well as methods for computer aided designing and making of these
devices. In the most preferred embodiment, the orthotic or
prosthetic devices comprise a cushioning layer superimposed onto an
orthotic or prosthetic shell, the cushioning layer comprising an
array of discrete solid and resilient cushioning elements that are
formed in an integral manner with the shell. In one embodiment of
the invention, the cushioning elements and the shell are formed
from the same material. In one preferred embodiment, said
cushioning structure comprises a cushioning element that is a beam,
defined around a centerline of any arbitrary shape. In another
preferred embodiment, said cushioning structure comprises a
cushioning element that has the shape of a spiral.
[0017] In preferred embodiments, a shell may be added on top and/or
below the cushioning elements without compromising the cushioning
function.
[0018] Because the cushioning layer comprises an array of discrete
solid and resilient cushioning elements, the cushioning elements
are able to react individually to an applied load, as opposed to
cushioning structures arranged in cellular topologies. A cushioning
structure in accordance with the present invention is therefore
very versatile: cushioning can be applied over large and over small
areas, and by changing the shape, the properties of the discrete
cushioning elements, their dimensions, the number of elements per
unit area, etc. the obtained deformation and the obtained supported
pressure can vary in a very large range, and this can moreover be
adapted, by the designer, from one area to another one. This is a
way in which the present invention allows to provide a
patient-specific prosthetic or orthotic device.
[0019] In embodiments, the prosthetic or orthotic device comprises
a means for adjustment integrated into a main body of the
prosthetic or orthotic device. Said means for adjustment may
include screws, cylindrical or conical shapes which press against
cushioning means directly or indirectly, e.g. press against a beam
which itself presses against one or more cushioning means, which
enables the application and/or adjustment of tension in one or more
cushioning structures. In another embodiment, the means for
adjusting properties of one or more cushioning means comprises of a
cylinder with local elevations, protrusions and/or depressions. The
cylinder presses against one or more cushioning elements, and by
rotating the cylinder around its central axis, the tension in one
or more cushioning structures can be adjusted. These adjustable
structures can be built in to the same part as the cushioning
means.
[0020] In any of the embodiments, rapid prototyping technology can
be used to fabricate the orthotic/prosthetic device.
[0021] The devices or selected parts of the devices may also be
impregnated or infiltrated with other substances such as resins,
polymers, gels, elastomers to alter their properties such as color,
hardness, flexural modulus, elongation at break, crack propagation,
density and surface porosity.
[0022] The present invention also provides a method for designing
an orthotic or prosthetic cushioned device, e.g. a computer based
method, comprising the steps of: [0023] providing scan data
describing at least part of the patient body; [0024] converting
said scan data into a 3D virtual model on the basis of which a 3D
design model of the orthotic or prosthetic device may be
constructed; [0025] adding automatically or interactively at least
one cushioning element from an electronic library of cushioning
elements to said 3D design model and; [0026] fabricating the
orthotic or prosthetic device.
[0027] Adding automatically or interactively at least one
cushioning element from a library of cushioning elements to said 3D
design model can include outputting a descriptor file of the
orthotic or prosthetic device for fabrication purposes.
[0028] The present invention also provides a method for adjusting,
modifying or arranging the cushioning elements manually with the
means of adjustment or controlled fully automatically by the
computer.
[0029] The present invention also provides a computer program
comprising instructions that when executed on a computing device
implement a method for: [0030] receiving scan data describing at
least part of the patient body; [0031] converting said scan data
into a 3D virtual model on the basis of which a 3D design model of
the orthotic or prosthetic device may be constructed; and [0032]
adding automatically or interactively at least one cushioning
element from a library of cushioning elements to said 3D design
model.
[0033] The computer program also comprises instructions for
arranging the cushioning and adjustment structures manually or
controlled fully automatically by the computer.
[0034] The computer program product can further comprise
instructions for exporting a description file for fabricating an
orthotic/prosthetic device from said design model of the
orthotic/prosthetic device.
[0035] The present invention also includes a machine readable
signal recording device on which is stored the computer program.
Examples of computer readable signal bearing media include:
recordable type media such as magnetic disks, e.g. floppy disks or
hard disks; or optical disks such as CD ROMs, DD-ROMs; or solid
state memory such as Random Access Memory, USB memory sticks, flash
memory; or magnetic tape storage media; or transmission type media
such as digital and analogue communication links.
BRIEF DESCRIPTION OF THE DRAWINGS
[0036] Embodiments of the invention will be described, by way of
example only, with reference to the accompanying drawings in
which:
[0037] FIG. 1 shows a block diagram for designing and manufacturing
an orthotic or prosthetic device comprising at least one cushioning
layer.
[0038] FIG. 2 illustrates cushioning elements according to an
embodiment of the present invention. FIG. 2 further illustrates a
2D representation of a beam.
[0039] FIG. 3 illustrates a cushioning element according to an
embodiment of the present invention.
[0040] FIG. 4 illustrates a 3D representation of a profile rotated
around an axis according to an embodiment of the present
invention.
[0041] FIG. 5 illustrates 2D representations of a spiral spring
structure according to an embodiment of the present invention.
[0042] FIG. 6 illustrates an array of cushioning elements according
to an embodiment of the present invention.
[0043] FIG. 7 illustrates an array of cushioning elements according
to an embodiment of the present invention.
[0044] FIG. 8 illustrates an array of the cushioning elements
according to an embodiment of the present invention.
[0045] FIGS. 9 to 13 show illustrations of cushioning structures
according to embodiments of the present invention.
[0046] FIG. 14 shows a 3D representation of a prosthesis socket
indicating possible locations for the cushioning structures.
[0047] FIG. 15 shows a 3D representation of an orthotic device
indicating possible locations for cushioning structures.
[0048] FIG. 16 illustrates a computer based system for use with
embodiments of the present invention.
DESCRIPTION OF PREFERRED EMBODIMENTS
[0049] In the following detailed description of the preferred
embodiments, reference is made to the accompanying drawings, which
form a part hereof, and within which are shown by way of
illustration specific embodiments by which the invention may be
practiced. The drawings described are only schematic and are
non-limiting. In the drawings, the size of some of the elements may
be exaggerated and not drawn on scale for illustrative purposes.
Those skilled in the art will recognize that other embodiments may
be utilized and structural changes may be made without departing
from the scope of the invention.
[0050] Furthermore, the terms first, second, third and the like in
the description and in the claims, are used for distinguishing
between similar elements and not necessarily for describing a
sequential or chronological order. It is to be understood that the
terms so used are interchangeable under appropriate circumstances
and that the embodiments of the invention described herein are
capable of operation in other sequences than described or
illustrated herein.
[0051] Moreover, the terms top, bottom, over, under and the like in
the description and the claims are used for descriptive purposes
and not necessarily for describing relative positions. It is to be
understood that the terms so used are interchangeable under
appropriate circumstances and that the embodiments of the invention
described herein are capable of operation in other orientations
than described or illustrated herein.
[0052] It is to be noticed that the term "comprising", used in the
claims, should not be interpreted as being restricted to the means
listed thereafter; it does not exclude other elements or steps.
Thus, the scope of the expression "a device comprising means A and
B" should not be limited to devices consisting only of components A
and B. It means that with respect to the present invention, the
only relevant components of the device are A and B.
[0053] In the following and in the attached claims reference may be
made to a "patient". It should be understood that this term patient
should be construed broadly to include not only humans but also
animals in need of surgery.
[0054] In the following and in the attached claims reference may be
made to an orthosis. It should be understood that an orthosis is an
external insert, device, support or brace designed to support a
patient in carrying the loads applied onto them by walking,
running, manipulating objects and/or similar activities and/or by
repositioning a limb or forcing them to move a certain way. They
can also spread the pressure between the body and the
shoe/ground/prosthetic over a larger surface area and provide
cushioning to the loaded areas.
[0055] In the following and in the attached claims reference may be
made to a prosthetic device or prosthesis. It should be understood
that a prosthetic device is an artificial extension of, or addition
to the human body or a replacement of a lost body part, e.g. to
replace a lost limb or any other body part. A prosthetic
limb--upper or lower extremity--usually consists of a prosthetic
socket which conforms to the residual limb, the artificial limb
itself, such as a hand or leg and some means of attaching the limb
to the socket.
[0056] For means of explaining the invention in more detail, the
following description refers to an ankle foot orthosis (AFO) that
is usually a plastic brace attaching to the calf of the subject
with a Velcro strap or lacing and with a sole part, fitting under
the foot which in some cases can fit inside a shoe. The present
invention is not limited to just such orthotic elements.
[0057] The purpose of an AFO is to control the ankle joint
rotations and possibly carry some of the forces applied through the
foot and ankle. Foot orthoses (FO) in the form of specially shaped
inserts which fit inside the shoe, have been found to be effective
for relieving pain and increasing mobility. It is believed that
they work by removing pressure from painful areas and by
re-aligning the foot. This is done by any of controlling abnormal
or excessive subtalar-, and/or midtarsal joint motion, distributing
the weight over a larger area and by offering cushioning and shock
absorption, where it is needed. It should be understood however
that the subject matter of this invention is also applicable to any
other orthotic or prosthetic device, including, but not limited to,
knee orthoses, knee-ankle-foot orthoses, hip orthoses,
hip-knee-ankle-foot-orthosis, lumbar orthoses, transtibial-,
transfemoral-, transradial-, transhumeral prosthesis--and
prosthesis sockets, sockets/adaptors for bone anchored prosthetics
and cranial helmets.
[0058] Referring now to the drawings, in particular FIG. 1, there
is shown a block diagram that illustrates a preferred embodiment
for designing and fabricating an orthotic or prosthetic device
according to the present invention. First, the patient, illustrated
by numeral 1 in FIG. 1, is sent to a scan facility with equipment
for capturing a 3D image of the target surface, e.g. the limb. The
scanning equipment in module 3 preferably generates a digitized
data file that provides data describing the target surface,
although the present invention is not limited to this form of
record of the patient's anatomy. Next, in module 4 the scanned data
may be imported into a computer program to convert the scanned data
into a 3D virtual model of the patient's limb/residual limb.
Alternatively, a cast of the limb/residual limb may be taken, as in
module 2, which can then be scanned in module 3 by the scanning
equipment. Once a virtual 3D model of the limb is constructed and
is available in the computer, a 3D model of the orthoses/prosthesis
may be designed based on the 3D model of the limb, as indicated by
module 5. This design of the 3D model of the orthoses/prosthesis
may be produced interactively or fully computer-controlled. As
module 6 indicates, a library system of cushioning structures may
be used in the design in order to incorporate a cushioning
structure in the 3D computer model of the orthoses/prosthesis. Once
the design is complete, it can be manufactured with a Rapid
Prototyping process, as in module 7.
[0059] The limb or residual limb has always a certain shape, which
is to be captured accurately in order to create a well-fitting
orthoses/prosthesis. The geometry can be captured non-weight
bearing or weight bearing through glass or Perspex (PMMA) or such,
transparent materials, which are pressed against the limb/residual
limb. Alternatively, the patient can stand on the transparent plate
and the weight bearing 3D shape obtained through the plate. The
geometry of the limb/residual limb can be captured using the
following means but not excluding other means of capturing it. In
module 1 in FIG. 1, laser scanning technology may be used to
generate a digital 3D geometry of the limb/residual limb shape.
This can be in the form of a point cloud, a solid surface
consisting of triangles or any other format for recording and
storing a 3D geometry. Another way of obtaining the geometry is to
manually make a plaster cast of the limb/residual limb and to use
the technique described above to capture the shape of the cast.
Alternatively, a positive made from the cast can be scanned. Making
casts is how the "traditional" process works and to be able to
accommodate this way of working is beneficial and the benefit is
obvious to anyone skilled in the art. Apart from laser scanning,
capturing the 3D geometry of the limb/residual limb may be done by
means of radiation, e.g. X-rays or ultrasound or through computer
tomography (CT) scans or magnetic resonance imaging (MRI) or any
other scanning method known to generate medical volumetric
data.
[0060] The geometry of the limb/residual limb determined in module
1 can be digitally imported into a computer program and may be
converted using algorithms known from the field of CAD/CAM
technology to produce a 3D computer model of the limb/residual
limb. A computer program such as 3-matic.TM. as supplied by
Materialise N.V., Leuven, Belgium, may be used for constructing
this 3D model. This geometry data can be used immediately in the
computer program or stored in a digital file.
[0061] Once the 3D model of the limb/residual limb is constructed,
it may be manipulated manually, semi-automatically or automatically
to design a 3D model of the orthotic/prosthetic device. These
manipulations may include one or more of the following processes
but are not limited to: [0062] 1. Scaling the geometry smaller or
larger along certain axis. [0063] 2. Giving the geometry a
thickness that can be varied throughout the part. [0064] 3. In
creating hollow volumes inside this thickness. [0065] 4. Adding new
surface shapes in certain parts, such as local elevations. [0066]
5. Adding predetermined 3D elements from a database system (E).
[0067] 6. Integrating the interventions made into an optimal
orthotic/prosthetic shape. [0068] 7. Adding attachment features
that enable the attachment of straps or other means to fasten the
orthotic/prosthetic device to the person using it. [0069] 8. Adding
holes or other features for ventilation purposes.
[0070] A preferred method for performing these actions uses a
computer program such a 3-matic as supplied by Materialise N.V.,
Leuven, Belgium.
[0071] A data base library 6 of one or more 3D models of cushioning
structures comprising cushioning elements or their mathematical
representations may then be used to incorporate at least one
cushioning element into the 3D model of the orthotic/prosthetic
device. The elements in the library may be selected manually or
automatically from the database by their pre-determined properties,
such as their physical dimensions, their appearance or their
mechanical properties, e.g. the spring coefficient, crack formation
and crack propagation. It is to be understood that the dimensions
and values regarding the performance of all cushioning elements
available in the library may be scaled in any dimension to obtain
the preferred or expected mechanical properties and performance.
Functions representing them and their performance are preferably
stored in this data base so that they can be called up when
required, automatically or manually by the user, and integrated
into the 3D design of the orthoses/prosthesis using the design
software. Specific elements may be called from the library or all
elements matching certain performance parameters for the user to
select for a particular location and purpose may be called. More
than one element can be selected by the library system to give
certain areas of cushioning structures specific properties.
[0072] In one preferred embodiment, according to FIG. 2, the
cushioning structure consists of one or more absorbing means such
as a bending moment absorbing means or a compression absorbing
means. The absorbing means may be formed from one or more beams.
The beams may be cantilevered from one end thereof, or may be
anchored at both ends thereof. An absorbing means such as a beam is
defined as any structure which shape can be clearly defined and
capable of absorbing the contact forces placed on the absorbing
means, e.g. beam by elastically deforming, e.g. by bending and/or
by compression. The deformation of one or more absorbing means such
as beams may create a sensation of having a soft surface if in
contact with the skin.
[0073] The cushioning properties of a structure refer to it being
compressibly resilient. This can mean the compressibility of the
material, the elastic deformation of the structure or a combination
thereof. This can be measured for example with the standard ISO
7619 or ASTM D2240. The areas of the orthotic/prosthetic device
that are cushioned using the embodiments described in this
invention have the Shore value of 20-90 when measured using an 00
durometer using these standards. This cushioning structure is not
foam. Each shape and feature in the cushioning structure is
determined deliberately either by the user or the computer system.
Shapes and features in the cushioning structure can be seamlessly
adjusted as needed by the computer system or the user.
[0074] In FIG. 2, beam 11 protrudes from main body 13 with an angle
12 that may vary for other cushioning elements. The beam centreline
14 is preferably linear or curved but may have any arbitrary shape.
Preferably, the beam cross-section 16 has a rectangular shape, but
may have any other arbitrary shape including but not limited to a
circular, triangular, semi-circular, elliptical, or square shape.
The cross-section may also vary within beam 11 along centreline 14
as needed. This will result in a great number of different beam
shapes, which can be designed as necessary. Beam 11 can also have a
radius where it attaches to main body 13 of the orthoses/prosthesis
to decrease local tensions. The end of the protrusion may also be
rounded to improve comfort if the protrusion is in contact directly
with the user as indicated by numeral 18 in FIG. 2A. In another
embodiment, the portion of cushioning elements that may be in
direct contact with the user may be made from another, suitable
material. As illustrated in FIG. 3, beam 11 may also re-connect
with the main body 13 where it started from. In FIG. 4, the
centreline 14 of the beam 11 has been rotated around an axis 17
over an angle 19. This can be done to any profile described
previously to create yet more different cushioning elements.
[0075] In another preferred embodiment, according to FIG. 5, the
cushioning element is a beam in the shape of a spiral 21.
Preferably, a cylindrical spiral 21 with a circular cross-section
is used, however, the spiral may revolve around any other geometry,
including but not limited to a cone or an elliptical cylinder and
may have any arbitrary shape as a cross-section. Preferably, the
axis 23 around which the spiral revolves is straight, but it may
have any arbitrary shape or follow any curve defined by a
mathematical function. In addition, another spring may also be
placed inside spiral 21--space permitting.
[0076] It should be understood that any combination of the previous
embodiments as described above is also within the scope of the
invention.
[0077] The cushioning elements may be patterned to create areas of
cushioning. The cushioning areas can consist of identical
cushioning elements or have several different element types mixed
up. In FIG. 6, a simple pattern is displayed where several
cushioning elements 31 are placed along a line with spacing 32. In
FIG. 7, several more patterns are illustrated, where the patterns
have also been separated by a spacing or gap 32. FIGS. 6 and 7
illustrate a cushioning layer comprising an array 35 of discrete
cushioning elements 31. As illustrated in FIG. 8, cushioning
elements 31 may also be placed next to each other with a separation
distance 32 and 33 in two directions. Apart from having spacing
between each other, the cushioning elements may also be placed at
an angle in relation to each other. The cushioning areas may be
defined e.g. on the basis of a pressure map or using markers with a
useful meaning that have been added to the 3D model of the limb and
may include large weight-bearing areas, such as plantar surfaces on
the foot or under a residual limb in a prosthetic socket, smaller
weight-bearing areas or areas of elevated contact pressure with the
ground and/or the orthotic/prosthetic device, such as calluses,
joints or local deformities, parts of the orthotic/prosthetic that
are in contact with the skin or any other areas of interest
designated by a person skilled in the art. The cushioning areas may
be created manually by selecting various cushioning elements from
the library or may be automatically generated. For the latter,
measurement data may be imported to the design software, which then
uses this data to select suitable structures according to logic
programmed therein and to place those structures automatically
where needed. For example, a pressure distribution measurement can
be imported into the system and if certain locations/areas have
pressure values matching a predetermined range of values, the
library system places specific features on those locations/areas
automatically. The designer can then accept or modify the proposed
design in any arbitrary way.
[0078] The thickness of the cushioning elements 11, 21, 31, such as
illustrated in FIGS. 2-13, is typically between 0.5 and 3 mm,
depending on the application. For applications involving high
loads, larger thicknesses may be used. In a preferred embodiment,
the thickness is less than 5 mm. The maximum dimension (length,
width or height) of a bounding box having the form of a rectangular
parallellepid just surrounding a cushioning element is preferably
less than 2 cm, more preferably less than 1 cm.
[0079] Having placed, as indicated in FIG. 9, a cushioning layer 45
of cushioning elements 31 on the orthotic or prosthetic shell 13 of
the orthotic/prosthetic devices, an additional shell 41, may be
created on top of the cushioning elements 31 attached to the
orthotic or prosthetic shell 13. This additional shell 41 can also
be created on top of a locally indicated area creating a hollow
volume with cushioning elements inside. If the shell is thin and/or
rigid enough, this will allow the surface to deform further
absorbing forces placed on it and it also allows the cushioning
elements below it to also deform and absorb forces. If the shell is
sufficiently rigid, it will spread the load placed on it to the
structures below if several structures are present. The stiffer the
shell is, the larger the area that will carry the loads. The
thickness of the shell may be varied throughout the surface to
alter its properties and the way it spreads the load with the
structures underneath. The shell may also act as a further
cushioning means depending on the compression ability of the
structure. Another layer of cushioning elements may be added on top
of this and there can be as many of these "sandwiched" layers as
needed. The resistance to deformation of the surface and the
cushioning elements may be controlled by altering the cushioning
elements' shape, geometry, material property, the manufacturing or
post-processing process parameters or any combination thereof
creating a controllable cushioning effect.
[0080] Moreover, the sandwiched cushioning layers may have
different properties (e.g. by using different cushioning elements,
different materials for the cushioning elements, etc.). An
advantage of these sandwiched layers is to make use of each of
these properties.
[0081] Further, one or more of the sandwiched cushioning layers may
comprise different areas that have mutually different cushioning
properties, obtained e.g. by the use of cushioning elements having
different shapes, materials, dimensions, by using a different
number of elements per unit area, etc.
[0082] The cushioning structures may comprise a means for
adjusting. Said means for adjustment may include a movable surface,
beam or a "plateau" that modifies at least one meaningful property
of the cushioning structure such as the spring coefficient, range
of movement, and the like. These features accomplish a modification
of at least one meaningful property by pressing against the
cushioning structure and preventing motion or creating tension in
the structure. This changes the deformability and compressibilit of
the structure. The moveable surface can also be inserted between
the deforming section of the cushioning structure and the main body
of the orthoses or prosthesis modifying the properties of the
deforming structure.
[0083] In one preferred embodiment, the means for adjustment may be
a cylindrical surface as indicated by 51 in module A in FIG. 10
that presses the cushioning element 31 towards the orthotic or
prosthetic shell 13. This surface 51 can be moved towards the
cushioning elements through means of linear motion as indicated by
54 in module B in FIG. 10 between the main orthoses/prosthesis
body, restricting the movement of the cushioning elements and thus
adjusting the cushioning effect. In one embodiment, this linear
motion is accomplished rotating a threaded cylinder as indicated by
55 in module C in FIG. 10 such as e.g. a screw. Furthermore, the
top surface of the cylinder may be flat or be inclined as indicated
by 56 in FIG. 11 or undulating or any combination thereof, offering
more possibilities with adjustment.
[0084] The surface on top of the cushioning structure as indicated
by 61 in module A and B in FIG. 12 can also move, if not attached
to the main orthoses/prosthesis body 13 in module A and C. In one
preferred embodiment, upper surface 61 in module A and B is
connected through the means of non-adjustable cushioning elements
31 in module B.
[0085] In another embodiment, an actuator or any other device is
used to move the moveable surface or one or more beams connected to
one or more cushioning structure allowing for the adjustment of
several structures simultaneously.
[0086] Another means of adjusting a cushioning element is presented
in FIG. 13, where a round, elliptical, concentric or cylinder or
one consisting of any combination thereof (60), can be rotated (62)
around an axis (63) perpendicular to the normal of the inner
surface of the orthotic/prosthetic (13). The rotation causes the
cushioning element (31) in contact with the cylinder to become
loaded or unloaded (66), adjusting its properties.
[0087] FIG. 14 schematically shows a transtibial prosthetic socket
71 that contains cushioning structures in cushioning areas 72 that
cushion the weight bearing parts of the prosthesis 71 and surface
areas 72 in contact with the most sensitive areas as known by a
person skilled in the art. FIG. 15 displays an orthosis 73, where
similar surface cushioning or cushioning on weight bearing areas 75
is needed. The surface and weight bearing types can be combined in
the same structure.
[0088] FIG. 16 is a schematic representation of a computing system
which can be utilized with the methods and in a system according to
the present invention including computer programs such as
3-matic.TM. as supplied by Materialise N.V., Leuven, Belgium. A
computer 150 is depicted which may include a video display terminal
159, a data input means such as a keyboard 155, and a graphic user
interface indicating means such as a mouse 156. Computer 150 may be
implemented as a general purpose computer, e.g. a UNIX workstation
or a personal computer.
[0089] Computer 150 includes a Central Processing Unit ("CPU") 151,
such as a conventional microprocessor of which a Pentium processor
supplied by Intel Corp. USA is only an example, and a number of
other units interconnected via bus system 154. The bus system 154
may be any suitable bus system--FIG. 16 is only schematic. The
computer 150 includes at least one memory. Memory may include any
of a variety of data storage devices known to the skilled person
such as random-access memory ("RAM"), read-only memory ("ROM"),
non-volatile read/write memory such as a hard disc as known to the
skilled person. For example, computer 150 may further include
random-access memory ("RAM") 152, read-only memory ("ROM") 153, as
well as a display adapter 1512 for connecting system bus 154 to a
video display terminal 159, and an optional input/output (I/O)
adapter 1511 for connecting peripheral devices (e.g., disk and tape
drives 158) to system bus 154. Video display terminal 159 can be
the visual output of computer 150, which can be any suitable
display device such as a CRT-based video display well-known in the
art of computer hardware. However, with a desk-top computer, a
portable or a notebook-based computer, video display terminal 159
can be replaced with a LCD-based or a gas plasma-based flat-panel
display. Computer 150 further includes user interface adapter 1510
for connecting a keyboard 155, mouse 156, optional speaker 157. The
relevant data describing the 3-D object to be formed may be input
directly into the computer using the keyboard 155 or from storage
devices such as 158, after which a processor carries out a method
in accordance with the present invention. The results of the method
may be transmitted to a further near or remote location, e.g. a
CAD/CAM processing facility to manufacture the template in
accordance with the details provided by computer 150.
[0090] A CAD/CAM manufacturing unit 1516 may also be connected via
a communications adapter 1517 to bus 154 connecting computer 150 to
a data network such as the Internet, an Intranet a Local or Wide
Area network (LAN or WAN) or a CAN. The manufacturing unit 1516 may
receive an output value or support descriptor file directly from
computer 150 running a computer program for support design in
accordance with the present invention or a value or descriptor file
derived from such an output of computer 150. Alternatively, the
unit 1516 may receive the relevant design data indirectly on a
suitable signal storage medium such as a diskette, a replaceable
hard disc, an optical storage device such as a CD-ROM or DVD-ROM, a
magnetic tape or similar.
[0091] Computer 150 also includes a graphical user interface that
resides within machine-readable media to direct the operation of
computer 150. Any suitable machine-readable media may retain the
graphical user interface, such as a random access memory (RAM) 152,
a read-only memory (ROM) 153, a magnetic diskette, magnetic tape,
or optical disk (the last three being located in disk and tape
drives 158). Any suitable operating system and associated graphical
user interface (e.g., Microsoft Windows, Linux) may direct CPU 151.
In addition, computer 150 includes a control program 1517 that
resides within computer memory storage 1516. Control program 1517
contains instructions that when executed on CPU 151 allow the
computer 150 to carry out the operations described with respect to
any of the methods of the present invention.
[0092] Those skilled in the art will appreciate that the hardware
represented in FIG. 16 may vary for specific applications. For
example, other peripheral devices such as optical disk media, audio
adapters, or chip programming devices, such as PAL or EPROM
programming devices well-known in the art of computer hardware, and
the like may be utilized in addition to or in place of the hardware
already described.
[0093] In the example depicted in FIG. 16, the computer program
product for carrying out the method of the present invention can
reside in any suitable memory. However, it is important that while
the present invention has been, and will continue to be, that those
skilled in the art will appreciate that the mechanisms of the
present invention are capable of being distributed as a computer
program product in a variety of forms, and that the present
invention applies equally regardless of the particular type of
signal bearing media used to actually carry out the distribution.
Examples of computer readable signal bearing media include:
recordable type media such as floppy disks and CD ROMs and
transmission type media such as digital and analogue communication
links.
[0094] Accordingly, the present invention also includes a software
product which when executed on a suitable computing device carries
out any of the methods of the present invention. Suitable software
can be obtained by programming in a suitable high level language
such as C and compiling on a suitable compiler for the target
computer processor.
[0095] Having designed the orthotic or prosthetic device, it can be
manufactured, as illustrated as module 6 in FIG. 1. In one
preferred embodiment, Rapid Prototyping and Manufacturing
(RP&M) techniques are used to manufacture the device. Rapid
Prototyping and Manufacturing (RP&M) can be defined as a group
of techniques used to quickly fabricate a scale model of an object
typically using three-dimensional (3-D) computer aided design (CAD)
data of the object. Currently, a multitude of Rapid Prototyping
techniques is available, including stereo lithography (SLA),
Selective Laser Sintering (SLS), Fused Deposition Modeling (FDM),
foil-based techniques, etc.
[0096] A common feature of these techniques is that objects are
typically built layer by layer. Stereo lithography, presently the
most common RP&M technique, utilizes a vat of liquid
photopolymer "resin" to build an object a layer at a time. On each
layer, an electromagnetic ray, e.g. one or several laser beams
which are computer-controlled, traces a specific pattern on the
surface of the liquid resin that is defined by the two-dimensional
cross-sections of the object to be formed. Exposure to the
electromagnetic ray cures, or, solidifies the pattern traced on the
resin and adheres it to the layer below. After a coat had been
polymerized, the platform descends by a single layer thickness and
a subsequent layer pattern is traced, adhering to the previous
layer. A complete 3-D object is formed by this process.
[0097] Selective laser sintering (SLS) uses a high power laser or
another focused heat source to sinter or weld small particles of
plastic, metal, or ceramic powders into a mass representing the
3-dimensional object to be formed.
[0098] Fused deposition modeling (FDM) and related techniques make
use of a temporary transition from a solid material to a liquid
state, usually due to heating. The material is driven through an
extrusion nozzle in a controlled way and deposited in the required
place as described among others in U.S. Pat. No. 5,141,680.
[0099] Foil-based techniques fix coats to one another by means of
gluing or photo polymerization or other techniques and cut the
object from these coats or polymerize the object. Such a technique
is described in U.S. Pat. No. 5,192,539.
[0100] Typically RP&M techniques start from a digital
representation of the 3-D object to be formed. Generally, the
digital is sliced into a series of cross-sectional layers which can
be overlaid to form the object as a whole. The RP&M apparatus
uses this data for building the object on a layer-by-layer basis.
The cross-sectional data representing the layer data of the 3-D
object may be generated using a computer system and computer aided
design and manufacturing (CAD/CAM) software.
[0101] A selective laser sintering (SLS) apparatus is particularly
preferred for the manufacture of the orthotic or prosthetic device
from a computer model. It should be understood however, that
various types of rapid manufacturing and tooling may be used for
accurately fabricating these orthotic or prosthetic devices
including, but not limited to, stereolithography (SLA), Fused
Deposition Modeling (FDM) or milling.
[0102] The orthotic or prosthetic device may be manufactured in
different materials. Preferably, only materials that are
biocompatible with the human body are taken into account. In the
case SLS is used as a RP&M technique, the orthotic or
prosthetic device may be fabricated from a polyamide such as PA
2200 as supplied by EOS, Munich, Germany or Duraform PA from 3D
Systems, South Caroline, USA, or any other material known by those
skilled in the art may also be used. The orthotic/prosthetic may
also be painted and/or coated using any suitable means.
[0103] The present invention may provide one or more of the
following advantages: [0104] The quality of the devices is more
consistent as significant manual intervention is no longer needed.
[0105] Less labour is needed. The labor does not need to be as
skilled in all of the manual work phases. Only in scanning, CAD
design, finishing and fitting the parts. [0106] Less production
equipment may be needed (one machine). [0107] The current invention
may result in less waste from the manufacturing process. [0108] The
current invention may result in a faster production. [0109] The
current invention may result in more automated production. [0110]
With the current invention, there is no longer a need to store
casts as everything can be stored digitally and reproduced as
needed. Also, the whole orthotic/prosthetic treatment history of
the patient is available for clinicians to use when needed. [0111]
Built in adjustability gives the clinician more options when the
orthoses or prosthetic is fitted on the patient. Also, if there is
a change in the patient's condition, and/or shape of the
limb/residual limb, the adjustable device can still provide a good
fit and functionality.
* * * * *