U.S. patent application number 11/609355 was filed with the patent office on 2007-04-12 for custom prosthetic liner manufacturing system and method.
This patent application is currently assigned to THE OHIO WILLOW WOOD COMPANY. Invention is credited to Robert E. Arbogast, James M. Colvin, Christopher T. Kelley, Greg Pratt.
Application Number | 20070080479 11/609355 |
Document ID | / |
Family ID | 34620089 |
Filed Date | 2007-04-12 |
United States Patent
Application |
20070080479 |
Kind Code |
A1 |
Arbogast; Robert E. ; et
al. |
April 12, 2007 |
CUSTOM PROSTHETIC LINER MANUFACTURING SYSTEM AND METHOD
Abstract
A system and method for manufacturing a custom prosthetic liner.
The system may include a shape capture device for capturing the
shape of a residual limb. The captured shape may be used to
generate a 3-dimensional electronic liner model using a processor
and specialized software. A 3-dimensional electronic model of the
residual limb may also be produced. Preferably, an interface is
provided that allows a user of the system to alter the shape and/or
size of the 3-dimensional model(s) to allow the
subsequently-produced liner to accommodate particular features of
the residual limb. Data associated with at least the resulting
3-dimensional liner model is provided to a manufacturing facility
equipped to produce a custom liner therefrom. The data may be
remotely transmitted to the manufacturing facility. A positive
likeness of the residual limb is created from the data associated
with the 3-dimensional model(s), and is subsequently used as a mold
core in the liner molding process.
Inventors: |
Arbogast; Robert E.; (Mt.
Sterling, OH) ; Colvin; James M.; (Hilliard, OH)
; Kelley; Christopher T.; (Columbus, OH) ; Pratt;
Greg; (Boca Raton, FL) |
Correspondence
Address: |
STANDLEY LAW GROUP LLP
495 METRO PLACE SOUTH
SUITE 210
DUBLIN
OH
43017
US
|
Assignee: |
THE OHIO WILLOW WOOD
COMPANY
15441 Scioto Darby Road P.O. Box 130
Mt. Sterling
OH
43143
|
Family ID: |
34620089 |
Appl. No.: |
11/609355 |
Filed: |
December 12, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10724526 |
Nov 28, 2003 |
7162322 |
|
|
11609355 |
Dec 12, 2006 |
|
|
|
Current U.S.
Class: |
264/222 ;
264/257; 425/2 |
Current CPC
Class: |
A61B 5/0064 20130101;
A61B 5/1073 20130101; A61F 2002/607 20130101; G05B 2219/45168
20130101; A61F 2002/7831 20130101; A61F 2/7812 20130101; A61F
2002/5053 20130101; A61F 2002/505 20130101; A61F 2002/608 20130101;
A61B 5/1077 20130101; A61F 2002/5047 20130101; A61F 2/5046
20130101; Y10S 623/901 20130101 |
Class at
Publication: |
264/222 ;
264/257; 425/002 |
International
Class: |
B29C 33/40 20060101
B29C033/40 |
Claims
1. A system for producing a custom polymeric prosthetic liner,
comprising: a shape capture apparatus for capturing the
3-dimensional shape of an amputee's residual limb; a processing
device for generating a 3-dimensional electronic liner model using
said 3-dimensional shape captured by said shape capture apparatus,
said processing device optionally adapted to generate a
3-dimensional electronic residual limb model; a means of providing
data associated with said 3-dimensional electronic liner model,
said 3-dimensional electronic residual limb model, or both, to a
facility equipped to produce said custom liner; an apparatus for
creating at least one custom mold component from said data
associated with said 3-dimensional electronic liner model, said
3-dimensional electronic residual limb model, or both; a mold for
receiving and containing an amount of polymeric material, said mold
incorporating said at least one custom mold component; and a
molding machine for producing said custom prosthetic liner from
said mold.
2. The system of claim 1, wherein said shape capture apparatus
employs a plurality of spaced-apart image detectors.
3. The system of claim 1, wherein said processing device consists
of a computer program in combination with a device selected from
the group consisting of a laptop computer, a desktop computer, a
pen computer, a pocket personal computer (pocket PC), and a
personal data assistant (PDA).
4. The system of claim 1, wherein said at least one custom mold
component is produced from said data by a computer-controlled
machining device.
5. The system of claim 1, wherein said at least one custom mold
component is created from a closed-cell foam material.
6. The system of claim 1, wherein said at least one custom mold
component is a mold core for use with a common mold cavity.
7. The system of claim 6, wherein said mold cavity is selected
based on its size.
8. The system of claim 1, wherein said at least one custom mold
component is a mold cavity for use with a custom or common mold
core.
9. The system of claim 1, wherein said polymeric material is a
silicone, urethane, or thermoplastic elastomer material.
10. The system of claim 9, wherein said polymeric material is a
block copolymer material.
11. The system of claim 1, further comprising means for applying a
fabric covering to an outer surface of said custom prosthetic liner
during the liner manufacturing process.
12. The system of claim 1, further comprising the ability to modify
the shape of either or both of said 3-dimensional electronic models
to accommodate particular features of said residual limb in said
custom prosthetic liner.
13. The system of claim 1, further comprising the ability to select
liner materials and material properties.
14. The system of claim 1, further comprising the ability to
specify accessories to be included in/on said custom prosthetic
liner.
15. The system of claim 14, wherein the number, location, and/or
orientation of said accessories may be specified.
16. The system of claim 15, wherein said accessories are selected
from the group consisting of suspension components, reinforcement,
bladders (including inflatable bladders), additives, and
sensors.
17. The system of claim 1, further comprising a means of
communication with an automated system for configuring and
purchasing a medical device.
18. A method for producing a custom polymeric prosthetic liner,
comprising: using a shape capture apparatus to capture the
3-dimensional shape of an amputee's residual limb; using a
processing device to generate a 3-dimensional electronic liner
model from the captured shape; optionally, using said processing
device to generate a 3-dimensional electronic residual limb model
from the captured shape; providing a means of furnishing data
associated with said 3-dimensional electronic liner model, said
3-dimensional electronic residual limb model, or both, to a
facility equipped to produce said custom liner; creating at least
one custom mold component from said data associated with said
3-dimensional electronic liner model, said 3-dimensional electronic
residual limb model, or both; providing a mold adapted to receive
and contain an amount of polymeric material, said mold
incorporating said at least one custom mold component; and using a
molding machine to produce said custom prosthetic liner from said
mold.
19. The method of claim 18, wherein said means for capturing the
3-dimensional shape of an amputee's residual limb is a multiple
image detector shape capture device.
20. The method of claim 18, wherein said processing device consists
of a computer program in combination with a device selected from
the group consisting of a laptop computer, a desktop computer, a
pen computer, a pocket personal computer (pocket PC), and a
personal data assistant (PDA).
21. The method of claim 18, wherein said at least one custom mold
component is produced from said data by a computer-controlled
machining device.
22. The method of claim 18, wherein said at least one custom mold
component is created from a closed-cell foam material.
23. The method of claim 18, wherein said at least one custom mold
component is a mold core for use with a common mold cavity.
24. The method of claim 23, wherein said mold cavity is selected
based on its size.
25. The method of claim 18, wherein said at least one custom mold
component is a mold cavity for use with a custom or common mold
core.
26. The method of claim 18, wherein said polymeric material is a
silicone, urethane, or thermoplastic elastomer material.
27. The method of claim 26, wherein said polymeric material is a
block copolymer material.
28. The method of claim 18, further comprising applying a fabric
covering to an outer surface of said custom prosthetic liner during
the liner manufacturing process.
29. The method of claim 18, further comprising providing the
ability to manipulate the shape of either or both of said
3-dimensional electronic liner and residual limb models to
accommodate particular features of said residual limb in said
custom prosthetic liner.
30. The method of claim 18, further comprising providing the
ability to select liner materials and material properties.
31. The method of claim 18, further comprising providing the
ability to specify accessories to be included in/on said custom
prosthetic liner.
32. The method of claim 31, wherein the number, location, and
orientation of said accessories may also be specified.
33. The method of claim 31, wherein said accessories are selected
from the group consisting of suspension components, reinforcement,
bladders (including inflatable bladders), additives, and
sensors.
34. The method of claim 18, further comprising a providing a means
of communication with an automated system for configuring and
purchasing a medical device.
35. A system for producing a custom polymeric prosthetic liner,
comprising: a shape capture apparatus for capturing the
3-dimensional shape of an amputee's residual limb; a storage means
in communication with said shape capture apparatus for temporarily
storing data associated with said 3-dimensional shape of an
amputee's residual limb; a means of providing said data to a
facility equipped to produce said custom prosthetic liner; a means
at said facility for associating prosthetic liner parameters with
said data; an apparatus for creating at least one custom mold
component from said data associated with said 3-dimensional shape
of an amputee's residual limb and said prosthetic liner parameters;
a mold for receiving and containing an amount of polymeric
material, said mold incorporating said at least one custom mold
component; and a molding machine for forming said custom prosthetic
liner from said mold.
36. The system of claim 35, wherein said shape capture apparatus
employs a plurality of spaced-apart image detectors.
37. The system of claim 35, further comprising a processing device
in communication with said shape capture apparatus, said processing
device for generating a 3-dimensional electronic model of said
residual limb from said 3-dimensional shape captured by said shape
capture apparatus
38. The system of claim 37, wherein said processing device consists
of a computer program in combination with a device selected from
the group consisting of a laptop computer, a desktop computer, a
pen computer, a pocket personal computer (pocket PC), and a
personal data assistant (PDA).
39. The system of claim 35, further comprising a means for
generating numerical data representative of said 3-dimensional
model.
40. The system of claim 35, wherein said at least one custom mold
component is a mold core for use with a common mold cavity.
41. The system of claim 35, wherein said at least one custom mold
component is a custom mold cavity for use with a custom or common
mold core.
42. The system of claim 35, wherein said polymeric material is a
silicone, urethane, or block copolymer material.
43. The system of claim 42, wherein said mold allows a fabric
covering to be applied to an outer surface of said silicone,
urethane, or block copolymer material during the liner
manufacturing process.
44. The system of claim 35, further comprising the ability to
manipulate said data associated with said 3-dimensional shape of an
amputee's residual limb in order to accommodate particular features
of said residual limb in said custom prosthetic liner.
45. The system of claim 35, further comprising the ability to
select liner materials and material properties.
46. The system of claim 35, further comprising the ability to
specify accessories to be included in/on said custom prosthetic
liner.
47. The system of claim 35, further comprising a means of
communication with an automated system for configuring and
purchasing a medical device.
48. A method of producing a custom polymeric prosthetic liner,
comprising: using a shape capture apparatus to capture the
3-dimensional shape of an amputee's residual limb; providing a
storage means in communication with said shape capture apparatus
for temporarily storing data associated with said 3-dimensional
shape of an amputee's residual limb; providing a means of
furnishing said data to a facility equipped to produce said custom
prosthetic liner; providing a means at said facility for
associating prosthetic liner parameters with said data; creating at
least one custom mold component from said data associated with said
3-dimensional shape of an amputee's residual limb and said
prosthetic liner parameters; providing a mold for receiving and
containing an amount of polymeric material, said mold incorporating
said at least one custom mold component; and using a molding
machine to produce said custom prosthetic liner from said mold.
49. The method of claim 48, wherein said shape capture apparatus
employs a plurality of spaced-apart image detectors.
50. The method of claim 48, further comprising providing a
processing device in communication with said shape capture
apparatus, said processing device for generating a 3-dimensional
electronic model of said residual limb from said 3-dimensional
shape captured by said shape capture apparatus
51. The method of claim 50, wherein said processing device consists
of a computer program in combination with a device selected from
the group consisting of a laptop computer, a desktop computer, a
pen computer, a pocket personal computer (pocket PC), and a
personal data assistant (PDA).
52. The method of claim 48, further comprising providing means for
generating numerical data representative of said 3-dimensional
model.
53. The method of claim 48, wherein said at least one custom mold
component is a mold core for use with a common mold cavity.
54. The method of claim 48, wherein said at least one custom mold
component is a custom mold cavity for use with a custom or common
mold core.
55. The method of claim 48, wherein said polymeric material is a
silicone, urethane, or block copolymer material.
56. The method of claim 55, further comprising applying a fabric
covering to an outer surface of said silicone, urethane, or block
copolymer material during the liner manufacturing process.
57. The method of claim 48, further comprising manipulating said
data associated with said 3-dimensional shape of an amputee's
residual limb in order to accommodate particular features of said
residual limb in said custom prosthetic liner.
58. The method of claim 48, further comprising selecting liner
materials and material properties.
59. The method of claim 48, further comprising specifying
accessories to be included in/on said custom prosthetic liner.
60. The method of claim 48, further comprising communicating with
an automated system for configuring and purchasing a medical
device.
61. A system for producing a custom polymeric prosthetic liner,
comprising: a shape capture apparatus for capturing the
3-dimensional shape of an amputee's residual limb; a processing
device running a computer program for generating a 3-dimensional
electronic residual limb model from said 3-dimensional shape
captured by said shape capture apparatus, said processing device
and computer program further adapted to generate a 3-dimensional
electronic liner model from said residual limb model and input
liner parameters; an interface for allowing a user of said system
to operate said computer program to modify said 3-dimensional
electronic residual limb model, said 3-dimensional electronic liner
model, or both, if so desired; an interface for allowing a user of
said system to specify liner parameters; optionally, an interface
for allowing a user of said system to communicate with a separate
system and computer program that facilitates the automatic
configuration and purchasing of a medical device; a storage device
for temporarily storing data associated with said 3-dimensional
electronic residual limb model and said 3-dimensional electronic
liner model; a transmission device for allowing data associated
with a finalized version of said 3-dimensional electronic liner
model, said 3-dimensional electronic residual limb model, or both,
to be remotely sent to a manufacturing facility equipped to produce
said custom prosthetic liner; a means at said manufacturing
facility for receiving said data associated with said finalized
version of said 3-dimensional electronic liner model, said
3-dimensional electronic residual limb model, or both, and for
reading said data or converting said data into a readable form; an
apparatus for creating at least one custom mold component from said
data associated with said 3-dimensional electronic liner model,
said 3-dimensional electronic residual limb model, or both; a mold
for receiving and containing an amount of polymeric material, said
mold incorporating said at least one custom mold component; and a
molding machine for forming said custom prosthetic liner from said
mold.
62. The system of claim 61, wherein said shape capture apparatus
employs a plurality of spaced-apart image detectors.
63. The system of claim 61, wherein said processing device consists
of a device selected from the group consisting of a laptop
computer, a desktop computer, a pen computer, a pocket personal
computer (pocket PC), and a personal data assistant (PDA).
64. The system of claim 61, wherein said polymeric material is a
silicone, urethane, or block copolymer material.
65. The system of claim 64, wherein said mold allows a fabric
covering to be applied to an outer surface of said silicone,
urethane, or block copolymer material during the liner
manufacturing process.
66. A system for producing a custom polymeric prosthetic liner,
comprising: a shape capture apparatus for capturing the
3-dimensional shape of an amputee's residual limb; a processing
device running a computer program for generating a 3-dimensional
electronic residual limb model from said 3-dimensional shape
captured by said shape capture apparatus, said processing device
and computer program further adapted to generate a 3-dimensional
electronic liner model from said residual limb model and input
liner parameters; an interface for allowing a user of said system
to operate said computer program to modify said 3-dimensional
electronic residual limb model, said 3-dimensional electronic liner
model, or both, if so desired; an interface for allowing a user of
said system to specify liner parameters; optionally, an interface
for allowing a user of said system to communicate with a separate
system and computer program that facilitates the automatic
configuration and purchasing of a medical device; a storage device
for temporarily storing data associated with said 3-dimensional
electronic residual limb model and said 3-dimensional electronic
liner model; a transmission device for allowing data associated
with a finalized version of said 3-dimensional electronic liner
model, said 3-dimensional electronic residual limb model, or both,
to be remotely sent to a manufacturing facility equipped to produce
said custom prosthetic liner; a means at said manufacturing
facility for receiving said data associated with said finalized
version of said 3-dimensional electronic liner model, said
3-dimensional electronic residual limb model, or both, and for
reading said data or converting said data into a readable form; an
apparatus for creating at least one custom mold component from said
data associated with said 3-dimensional electronic liner model,
said 3-dimensional electronic residual limb model, or both; a mold
for receiving and containing an amount of polymeric material, said
mold incorporating said at least one custom mold component; and a
molding machine for forming said custom prosthetic liner from said
mold.
67. The system of claim 66, wherein said shape capture apparatus
employs a plurality of spaced-apart image detectors.
68. The system of claim 66, wherein said processing device consists
of a device selected from the group consisting of a laptop
computer, a desktop computer, a pen computer, a pocket personal
computer (pocket PC), and a personal data assistant (PDA).
69. The system of claim 66, wherein said at least one custom mold
component is a mold core for use with a common mold cavity.
70. The system of claim 66, wherein said at least one custom mold
component is a mold cavity for use with a custom or common mold
core.
71. The system of claim 66, further comprising the ability to use
said computer program to select liner materials and material
properties.
72. The system of claim 66, wherein said polymeric material is a
silicone, urethane, or block copolymer material.
73. The system of claim 72, wherein said mold allows a fabric
covering to be applied to an outer surface of said silicone,
urethane, or block copolymer material during the liner
manufacturing process.
74. A system for producing a custom polymeric prosthetic liner,
comprising: a shape capture apparatus for capturing a 3-dimensional
shape of an amputee's residual limb; a processing device running a
computer program for generating a 3-dimensional electronic liner
model from said 3-dimensional shape captured by said shape capture
apparatus and liner parameters input by user of said system; an
optional interface for allowing a user of said system to operate
said computer program to view and modify a 3-dimensional electronic
residual limb model prior to generation of said 3-dimensional
electronic liner model, data associated with said 3-dimensional
residual limb model subsequently used in generating said
3-dimensional electronic liner model; an interface for allowing a
user of said system to operate said computer program to specify
accessories to be included in/on said custom prosthetic liner;
optionally, an interface for allowing a user of said system to
communicate with a separate system and computer program that
facilitates the automatic configuration and purchasing of a medical
device; a means for temporarily storing data associated with a
finalized 3-dimensional electronic liner model, said 3-dimensional
residual limb model, or both; a transmission device for allowing
data associated with said finalized 3-dimensional electronic liner
model, said 3-dimensional residual limb model, or both, to be
remotely sent to a manufacturing facility equipped to produce said
custom prosthetic liner; a means at said manufacturing facility for
receiving said data associated with said finalized 3-dimensional
electronic liner model, said 3-dimensional residual limb model, or
both, and for reading said data or converting said data into a
readable form; an apparatus for creating at least one custom mold
component from said data; a molding machine for forming said custom
prosthetic liner from a mold incorporating said at least one custom
mold component; once said custom prosthetic liner is completed, a
storage means for storing said data associated with said finalized
version of said 3-dimensional electronic liner model, said
3-dimensional electronic residual limb model, or both, for future
use; and a storage system for storing said at least one custom mold
component for future use, said storage system including a means for
identifying a particular custom mold component with a particular
amputee.
75. The system of claim 73, wherein said liner is manufactured from
a silicone, urethane, or block copolymer material.
76. The system of claim 75, wherein said mold allows a fabric
covering to be applied to an outer surface of said silicone,
urethane, or block copolymer material during the liner
manufacturing process.
77. A system for producing a custom polymeric prosthetic liner,
comprising: shape data associated with an amputee's residual limb;
a processing device in conjunction with a computer program for
generating a 3-dimensional electronic liner model from said data
and liner parameters input by a user of said system; optionally, an
interface for allowing a user of said system to operate said
computer program to view and modify a 3-dimensional electronic
residual limb model if so desired, data associated with said
3-dimensional electronic residual limb model subsequently used in
the generating said 3-dimensional electronic liner model; a means
of providing data associated with said 3-dimensional electronic
liner, said 3-dimensional electronic residual limb model, or both,
to a facility equipped to produce said custom liner; an apparatus
for creating at least one custom mold component from said data; a
mold for receiving and containing an amount of polymeric material,
said mold incorporating said at least one custom mold component;
and a molding machine for producing said custom prosthetic liner
from said mold.
78. The system of claim 77, wherein said shape data is in the form
of a cast of said residual limb.
79. The system of claim 77, further comprising an electronic shape
capture apparatus that is used to capture a 3-dimensional image of
an interior of said cast.
80. The system of claim 77, wherein said shape data is in the form
of measurements of said residual limb.
81. The system of claim 77, further comprising an interface for
allowing a user of said system to input said measurements into said
computer program.
82. The system of claim 77, wherein said polymeric material is a
silicone, urethane, or block copolymer material.
83. The system of claim 82, wherein said mold allows a fabric
covering to be applied to an outer surface of said silicone,
urethane, or block copolymer material during the liner
manufacturing process.
84. A method of producing a custom polymeric prosthetic liner,
comprising: obtaining shape data associated with an amputee's
residual limb; providing a processing device in conjunction with a
computer program for generating a 3-dimensional electronic liner
model from said shape data and liner parameters input by a user of
said system; optionally, providing an interface for allowing a user
of said system to operate said computer program to view and modify
a 3-dimensional electronic residual limb model if so desired, data
associated with said residual limb model subsequently used in
generating said liner model; providing data associated with said
residual limb shape, said 3-dimensional electronic liner model, or
both, to a manufacturing facility equipped to produce said custom
liner; creating at least one custom mold component from said data;
providing a mold for receiving and containing an amount of
polymeric material, said mold incorporating said at least one
custom mold component; and using a molding machine to produce said
custom prosthetic liner from said mold.
85. The method of claim 84, wherein said shape data is in the form
of a cast of said residual limb.
86. The method of claim 84, further comprising using an electronic
shape capture apparatus to capture a 3-dimensional image of an
interior of said cast.
87. The method of claim 84, wherein said shape data is in the form
of measurements of said residual limb.
88. The method of claim 84, further comprising providing an
interface for allowing a user of said system to input said
measurements into said computer program.
89. The method of claim 84, wherein said polymeric material is a
silicone, urethane, or block copolymer material.
90. The method of claim 89, further comprising applying a fabric
covering to an outer surface of said silicone, urethane, or block
copolymer material during the liner manufacturing process.
Description
[0001] This application is a continuation of U.S. patent
application Ser. No. 10/724,526 filed on Nov. 28, 2003, which is
hereby incorporated by reference herein.
BACKGROUND
[0002] The present invention relates to the
production/manufacturing of custom liners for use with prosthetic
limbs of various type. More specifically, the present invention
relates to a system and method of manufacturing custom prosthetic
liners, whereby a prosthetist or other qualified practitioner can
capture the shape of an amputee's residual limb, manipulate data
relating to said shape, if desired, and transmit or otherwise
provide said data to a manufacturing facility that is equipped to
receive the data and to manufacture a custom prosthetic liner
therefrom.
[0003] While there are various types of prosthetic limbs, the most
common are likely those designed to replace some portion of an arm
or leg. While a liner manufactured by the system and method of the
present invention will work equally well in either application, for
purposes of simplicity, we will confine the immediately following
discussion of the present invention and relevant known technologies
primarily to that of a prosthetic leg. From this discussion, it can
be understood that the system and method of the present invention
offers advantages not available with known systems and methods for
producing prosthetic liners--regardless of the specific type of
liner produced.
[0004] Most prosthetic legs may be categorized as either below knee
(BK), or above knee (AK) prosthetics. A BK prosthetic leg is
designed to fit an amputee whose residual limb terminates at some
point below the knee joint (i.e., the knee joint is still present).
BK amputations are often referred to as transtibial amputations, as
the amputation point passes through the tibia of the lower leg. An
AK prosthetic leg is designed to fit an amputee whose residual limb
terminates at some point above the knee joint (i.e., the knee joint
has been removed). AK amputations are often referred to as
transfemoral amputations, as the amputation point passes through
the femur of the upper leg. Other categories of prosthetic legs
include Symes, knee disarticulations, and hip disarticulations.
[0005] Whether a prosthetic leg is designed for a BK or an AK
amputee, the leg will generally have some common components. For
example, a BK prosthetic leg will generally have an upper portion
comprising a socket that is provided to receive a portion of the
amputee's residual limb. To the bottom of the socket is typically
affixed a lower portion, normally comprising an upright assembly of
some type that is connected to a foot or ground-contacting portion.
During initial development of prosthetic legs, the upright assembly
may simply have been a rod or similar structure used to impart the
prosthetic leg with the proper length. A foot or similar structure
may not even have been included. Modern BK prosthetic legs may make
use of more complex upright assemblies that may provide for damping
or other desirable properties. The upright assembly portion of a BK
prosthetic leg may also be shaped to simulate the appearance of a
real leg.
[0006] AK prosthetic legs will also generally have an upper, socket
portion, that is provided to receive a portion of the amputee's
residual limb. An AK prosthetic limb will also typically have a
lower portion attached to the bottom of the socket. Normally, the
lower portion of an AK prosthetic limb will also have an upright
assembly of some type that is connected to a foot or
ground-contacting portion. Older AK prosthetic limbs sometimes
incorporated a rudimentary type of pivoting assembly to connect the
lower portion to the socket. This allowed the amputee to swing the
lower portion of the prosthetic limb forward during walking, in an
attempt to simulate the amputee's natural gait. Modern AK
prosthetic limbs are typically more complicated. For example,
hydraulic or pneumatic cylinders, or some other type of damping
device may be provided at the knee joint to better control the
bending thereof.
[0007] Whether the prosthetic leg in question is of the BK or AK
type, and whether the leg is simple or complex in design,
acceptable use thereof still depends to a great extent on the fit
of the amputee's residual leg into the socket of the prosthetic
leg. No matter how well the prosthetic leg is otherwise designed,
if the fit of the residual leg within the socket is not adequate,
the prosthetic leg may irritate the residual leg, cause pain to the
amputee, and/or may not be adequately retained. Thus, without a
proper fit of the residual leg to the socket, a prosthetic leg can
be substantially unusable.
[0008] In the early days of prosthetics development and
manufacture, amputees had little choice as to how a prosthetic leg
was fit and retained on the residual limb. For example, at one
time, both BK and AK amputees had to rely on a "skin fit," whereby
the skin of the residual leg produced a seal against the inner
surface of the socket. In this retention method, at least a portion
of the air in the socket is displaced by the residual leg during
donning of the prosthetic leg. The displacement of air ideally
creates a vacuum within the socket that retains the prosthetic leg
on the residual leg. The seal between the skin and the inner
surface of the socket is crucial to preventing air from entering
the socket and, therefore, maintaining the vacuum.
[0009] There are numerous problems with a skin fit, however. Most
notably, the constant contact of the skin against the hard inside
surface of the socket can become painful, and can also cause
problems with the skin of the residual leg. For example, the fit of
the socket against the residual leg may press on nerves or other
sensitive spots thereof. This problem may be exacerbated when the
residual leg has little flesh, or exhibits particularly bony areas.
Also, the skin of the residual leg may become irritated, chapped or
raw, or may otherwise develop sore spots, lesions, or similar areas
of weakness due to its contact with the socket. A skin fit may also
cause the residual leg to perspire, jeopardizing the seal between
the residual leg and socket, and further contributing to problems
with the amputee's skin. Additionally, when employing a skin fit,
powders, gels, or other similar lubricants are typically required
to be spread over the residual leg and/or the inner surface of the
socket in order to allow the residual leg to be properly inserted
therein. Such surface modifiers are not only messy, they may be
uncomfortable, and may further contribute to problems with the skin
of the residual leg.
[0010] To alleviate the above-described problems, attempts have
been made to produce a covering that may be placed over the
residual leg prior to its insertion into the prosthetic leg socket.
These attempts initially involved only BK prosthetics. The first
such coverings developed for this purpose are best characterized as
socks. These socks were typically manufactured of a fabric material
of some thickness, which could be pulled over the distal end of the
residual leg prior to its insertion into a socket. Such socks were
problematic, however, particularly because they often lacked
adequate comfort and secure suspension.
[0011] In an attempt to overcome the deficiencies of the sock-type
liner, a silicone liner was introduced. This initial silicone liner
was offered in the form of a kit. Before employing the kit to
produce a liner, it was first necessary to produce a mold of the
amputee's residual leg. This was typically accomplished by creating
a cast of the residual leg, and then filling the cast with plaster
or some other material to create a positive mold. The materials
provided in the kit could then be mixed together in a lab, and
somehow applied to the outer surface of the mold. As can be
imagined, this process is cumbersome, messy, and likely produces a
liner of substantially less than uniform thickness. The liner also
could not simply be purchased from a supplier but, rather, had to
be produced by a prosthetist or other practitioner qualified to
cast the residual leg and subsequently produce the liner. In
addition, a liner produced using this kit was required to be
attached to a prosthetic leg via a pin connection, as a suction fit
between the liner and the socket was not attainable. Moreover, as
silicone tends to cling to other materials, a lubricant was again
typically required to allow its insertion into a prosthetic leg
socket.
[0012] A generic silicone liner was next developed, which liner
dispensed with the necessity of purchasing a kit of materials and
handcrafting a liner therefrom. This liner consisted substantially
of a roll-on silicone sleeve. A few different sizes of the sleeve
were produced, and the practitioner was required to select the size
which most closely approximated the size of the amputee's residual
leg. This generic silicone sleeve was designed primarily to allow
for improved suspension (retention) of a prosthetic leg on a
residual leg via a mechanical pin lock. Unfortunately, because the
residual leg can be of virtually unlimited size and shape, it was
often difficult to select a liner that fit acceptably.
Additionally, similar to its predecessor, this liner required that
powder be applied to the residual leg, to the outer surface of the
liner, or both, in order to facilitate donning of the liner and
insertion thereof into a prosthetic leg socket.
[0013] Next introduced was what may be accurately described as a
gel sock. As opposed to the silicone material of two of the
aforementioned liners, this gel sock was manufactured by dipping a
former into a gel material. The gel sock was very thin and offered
no means of suspension. The thin construction also provided for
little cushioning. Another substantial disadvantage of the gel sock
was that it commonly caused adverse reactions of an amputee's skin
when worn. This is believed to be the result of the gel material
itself, which is thought to have been solvent-based.
[0014] A urethane liner was subsequently introduced, which liner
alleviated some of the problems inherent to the above-described
liners. Unfortunately, this urethane liner had problems of its own.
First, a prosthetist was again required to make a cast or mold of
an amputee's residual leg, which cast or mold had to be thereafter
sent to the sole company that produced the liners. Because the
manufacturing process associated with this liner is relatively
slow, it often took weeks to receive the liner after sending out
the cast or mold. These urethane liners were generally also
substantially thicker than the liners previously described. Because
the urethane material has a much higher density, these liners were
also typically much heavier than the preceding liners. A further
drawback associated with this liner and liner manufacturing method
is the fact that the liner manufacturer must keep a positive mold
of the amputee's residual leg if additional liners are to be made
for that amputee in the future. As the typical mold was made from
plaster, such molds are generally, fragile, and take up a not
insubstantial amount of space. Yet another drawback was that this
system was not compatible with a pin suspension. Additionally,
similar to several of the aforementioned previously known liners,
the amputee's residual leg generally had to be lubricated prior to
donning the urethane liner.
[0015] It should be realized, that in addition to the illustrated
deficiencies inherent to the aforementioned previously known
liners, such liners were also typically only available for use with
BK prosthetics. In fact, to the best of the Applicant's knowledge,
no form of liner was available for use with AK prosthetics until
approximately the mid-1990's, and the use of liners with AK
prostheses employing suction retention did not gain acceptance
until approximately 2001.
[0016] The Applicant currently manufactures and sells a liner that
is substantially superior to those liners discussed above. The
Applicant's current liner, known commercially as the Alpha.RTM.
liner, is available to amputees as an off-the-shelf product. This
liner is generally manufactured from a novel block copolymer
material to which is adhered a fabric covering. The fabric-covered
liner is easily rolled onto the residual leg or arm, with the
fabric material facing out. The fabric material allows for easy
donning and doffing of a prosthetic limb, as the inner surface of
the prosthetic limb socket slides easily over the fabric. The
fabric material also improves the durability, stability, and
cosmetic appearance of the liner. In comparison to the
aforementioned liners, the Applicant's existing liner is generally
longer, with the block copolymer material typically extending
substantially to the edge of the fabric that typically extends
beyond the brim of the socket. The design of the Applicant's
existing liner offers superior cushioning, better prevents air
entry, and reduces the chances of perspiration forming around the
portion of the residual limb that resides within the prosthetic
limb socket. Also, the particular block copolymer material used
allows the liner to better conform to the shape of the amputee's
residual limb, and may contain additives, such as mineral oil,
which act to condition the skin.
[0017] In a similar manner to the aforementioned and previously
known liners, however, the Applicant's present liner has been
heretofore available in only a few standard sizes. Thus, an amputee
has up until now been required to order an Alpha.RTM. liner of a
size that most closely approximates the size of their residual
limb. Due to its design and construction, such an off-the-shelf
Alpha.RTM. liner still typically provides for a comfortable
fit--and is still generally superior to previous liners. This is
due in part to the ability of the Alpha.RTM. liner to conform to
the shape of an amputee's residual limb as the liner is worn.
However, the ability to manufacture such a liner that is also
customized to fit an individual amputee remains desirable, as such
a custom liner would provide for an even further improvement in
fit, and may be especially beneficial to amputees who have, for
example, highly sensitive, bony, or unusually shaped residual
limbs.
[0018] For certain of the reasons described above with respect to
known prosthetic liners, as well as for other reasons, it has up
until now been impractical to produce a custom liner. For example,
using typical known techniques would require the plaster casting of
an amputee's residual limb, the production therefrom of a positive
replica of the residual limb, and storage of the positive replica
to allow for the production of future liners. In addition, it would
be extremely cost prohibitive to manufacture a liner mold designed
specifically to account for the peculiarities of each amputee's
residual limb.
SUMMARY OF EXEMPLARY EMBODIMENT(S)
[0019] The system and method of the present invention overcomes the
aforementioned problems and allows the manufacture of a custom
prosthetic liner of any type (i.e., leg, arm, etc.) in a timely and
cost efficient manner. The system and method of the present
invention eliminates the need to cast an amputee's residual limb in
order to obtain the accurate shape thereof. Rather, one embodiment
of the system and method of the present invention can obtain the
accurate shape of an amputee's residual limb by making use of a
shape capture device to capture the 3-dimensional shape of the
residual limb with a high degree of accuracy, or through the
application of measurements to a shape template. Software
associated with the shape capture device may optionally be used to
convert the 3-dimensional shape (image) into a 3-dimensional
electronic model that accurately represents the residual limb.
Alternatively, the software associated with the shape capture, or
other software, can apply measurements to a shape template to
produce a 3-dimensional electronic model that represents the
residual limb. The software, through an interface, preferably also
allows a prosthetist or other qualified practitioner to produce a
3-dimensional electronic model of a liner that makes use of the
exterior shape of the residual limb to calculate its interior
geometry. The liner model can be generated regardless of whether a
residual limb model has been generated. If used, the practitioner
can modify the residual limb model in order to further fine-tune
the fit of the liner that will be produced therefrom. Once the
liner model is deemed to be in acceptable form, the data associated
therewith is transmitted or otherwise provided to a manufacturing
facility that is equipped to receive the data and to produce a
liner therefrom. In one embodiment of the present invention, the
data is used to produce a 3-dimensional positive likeness of the
(modified or unmodified) residual limb from a selected material.
The 3-dimensional positive likeness of the residual limb can then
be used as a mold core in conjunction with a standard (existing)
liner mold cavity to produce a custom prosthetic liner. Thus, this
embodiment of the system and method of the present invention does
not require the use of a wholly unique liner mold in order to
produce the custom liner. In another embodiment of the present
invention, the data may be used to produce unique positive (core)
and negative (cavity) portions of a liner mold. In this embodiment
of the present invention, the whole of each mold is then unique to
a particular amputee. While this method is likely more costly than
the previously described method, it is contemplated that such molds
could be manufactured of low cost materials, as such molds are not
likely to experience a high number of molding cycles.
[0020] The system and method of the present invention may be
utilized by having an amputee visit, for example, a prosthetist or
other practitioner's office, wherein the shape capture of the
amputee's residual limb and the optional modification of the
subsequently generated electronic model may take place.
Alternatively, the shape capture device may be transported to the
location of the amputee. In this case, the captured shape of the
residual limb can be converted to a 3-dimensional model and
optionally modified while at the amputee's location, such as
through the use of a laptop, pen, or pocket computer, or a personal
data assistant (PDA), or the captured shape of the residual limb
may be saved for later processing at a different location. The
finalized data representing the electronically modelled residual
limb can be delivered to a qualified manufacturing facility in any
number of ways, such as, for example, by delivery on a machine
readable storage medium, by wired or wireless transmission over the
Internet, or by direct transfer from machine to machine (such as,
for example, from a laptop computer to another computer, or to a
CNC or similarly controlled machining device). In an alternate
embodiment of the present invention, a conventional plaster cast of
the residual limb can be taken, and the cast subsequently digitized
to obtain an electronic model of the residual limb. This embodiment
of the present invention may be practiced, for example, when a cast
of the residual limb already exists, or when a practitioner prefers
to continue working with plaster.
[0021] In any event, the system and method of the present invention
allows an amputee to easily acquire a prosthetic liner that is
customized to fit his/her residual limb, thereby providing for
maximum comfort and support. Further, the first and subsequent
custom liners can be ordered from the manufacturer(s) in the same
manner as other prosthetic supplies, and can be delivered to the
amputee in a timely manner and at a reasonable price. The system
and method of the present invention also makes the storage of
residual limb casts or molds optional, as the data required to
produce the liner can be stored in electronic form. The system and
method of the present invention may further permit a prosthetist or
other qualified practitioner to specify options for inclusion on
the liner, such as, for example: different types of suspension
components and their size, location and orientation; bladders
(including inflatable bladders) and their location and size; liner
materials and material properties, including hardness, elasticity;
the inclusion of additives, such as anti-microbials, therein; liner
cover properties; and, sensors and their type and location.
Additionally, the system and method of the present invention may
allow for the manufacture of a custom liner that permits an amputee
whose residual limb size/shape has changed, to continue using
his/her existing socket. Similarly, it may be possible to produce
custom liners that allow amputees to use a generic socket, with the
difference in shape being accounted for by the liner, thereby
greatly reducing the overall cost of a prosthetic limb. Therefore,
as can be seen from the foregoing discussion, and as can be even
better understood from a reading of the following detailed
description of exemplary embodiments, the system and method of the
present invention permits the practical manufacture of a custom
prosthetic liner that has not been heretofore possible.
[0022] Although, for reasons of clarity, the preceding discussion
has been directed primarily to the use of liners with prosthetic
legs, it should be understood that the system and method of the
present invention can be used to produce a prosthetic liner for
virtually any type of prosthesis. Additionally, while in one
preferred embodiment the system and method of the present invention
is used to produce a custom prosthetic liner having a construction
like that of the Applicant's current Alpha.RTM. liner, nothing
herein is meant to limit the use of the system and method of the
present invention to such a construction or to any particular liner
materials.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] In addition to the features mentioned above, other aspects
of the present invention will be readily apparent from the
following descriptions of the drawings and exemplary embodiments,
wherein like reference numerals across the several views refer to
identical or equivalent features, and wherein:
[0024] FIG. 1 is a diagrammatic representation of the use of one
embodiment of the system and method of the present invention,
whereby a custom liner is produced for an individual amputee;
[0025] FIG. 2 is a diagrammatic representation of the use of an
alternate embodiment of the system and method of the present
invention, whereby a custom liner is produced that allows an
individual amputee having a residual limb that has changed in shape
and/or size to continue using his/her existing prosthetic socket;
and
[0026] FIG. 3 is a diagrammatic representation of the use of
another embodiment of the system and method of the present
invention, whereby a liner is produced that allows for the custom
fit of an individual amputee's residual limb to a generic
prosthetic socket.
DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENT(S)
[0027] The system and method of the present invention allows for
the efficient and cost effective manufacturing of a custom
prosthetic liner. The system and method of the present invention
will generally include: a means for scanning, photographing,
digitizing, measuring, or otherwise capturing the 3-dimensional
shape of an amputee's residual limb; an optional means for
converting the captured shape of the residual limb into a viewable
3-dimensional model; a means for producing a viewable 3-dimensional
liner model; a means for manipulating the 3-dimensional residual
limb and/or liner model in order to further enhance and customize
the fit and performance of the liner that will be manufactured
therefrom; a means for providing the finalized data associated with
the 3-dimensional liner model to a facility that will manufacture a
liner from the data; a means for producing a 3-dimensional likeness
(positive) of the (modified or unmodified) residual limb from the
data; and a means of using the 3-dimensional positive with either
existing or unique molding components to produce a liner customized
to fit the amputee's residual limb. As will become more clear
hereafter, certain embodiments of the present invention may not
include particular ones of these components, or may include
additional components.
[0028] It is to be understood that the system and method of the
present invention can be used to produce a custom liner to fit
virtually any type, size, or shape of prosthetic limb. While the
above discussion with respect to the present invention and known
prosthetic liners focused primarily on a liner for a prosthetic
leg, the system and method of the present invention is also capable
of producing liners for other types of prostheses, such as, for
example, prosthetic arms.
[0029] Manufacture of a custom prosthetic liner according to one
embodiment of the present invention requires an accurate
determination of the shape of the amputee's residual limb. The
residual limb may be scanned, photographed, videotaped, digitized,
or otherwise subjected to any process that can be reasonably
employed to accurately capture its shape. For example, the shape of
the residual limb may be captured by using a digitizing pen to
trace over its surface. Preferably, however, the residual limb is
exposed to a multiple-image detector shape capture device that is
able to accurately, and substantially instantaneously, capture the
3-dimensional shape of the residual limb. An exemplary, and
particularly suitable multiple-image detector shape capture device
and its method of use is disclosed in U.S. patent application Ser.
No. 10/641,895, entitled A Medical Socket Contour Scanning System,
which is hereby incorporated by reference herein. As can be
understood from reference to U.S. patent application Ser. No.
10/641,895, the shape of the amputee's residual limb can be
accurately and substantially instantaneously captured by using a
series of spaced-apart image detectors that are mounted to a
framework and are disposed to substantially surround the residual
limb.
[0030] Once the shape of the residual limb has been captured, it
may be converted into a viewable 3-dimensional model by software in
electronic communication with a processor. Thus, from the captured
shape, a 3-dimensional electronic model can be rendered, which the
prosthetist or other user of the system is preferably able to
observe from all angles. The software also preferably allows a user
of the system to rotate, flip, mirror, and otherwise alter the
viewing angle of the model in order to adequately inspect and/or
observe the shape of the residual limb. Alternatively, no viewable
model of the residual limb may be generated. Rather, the numeric
data associated with the captured shape of the residual limb may
simply be used to help produce an electronic liner model. As
discussed in more detail below, the software employed in the
present invention is preferably also provided with an interface or
is otherwise adapted to allow the user of the system to modify the
3-dimensional residual limb and liner models as deemed necessary to
account for particular features of the residual limb or particular
preferences or problems of the amputee. For example, in order to
account for areas of the residual limb that may be especially
sensitive, the model(s) may be manipulated to produce a liner that
is thicker in certain areas than in others.
[0031] As mentioned previously, in an exemplary embodiment of the
present invention, the shape capture portion of the liner
manufacturing process may be accomplished in a prosthetist or other
practitioner's office, or at the location of the amputee.
Consequently, the first substantive step of manufacturing a custom
liner according to the present invention involves a meeting between
the patient (amputee) and a practitioner 5. According to the system
and method of the present invention, the amputee may visit the
practitioner, or the practitioner may visit the amputee. During the
visit, the practitioner will typically examine the residual limb,
and may make note of particular characteristics of the residual
limb that will require special attention during the liner design
process. The practitioner next determines an appropriate basic
liner size 10, which is typically selected based on the relative
size of the residual limb. Thereafter, an acceptable shape capture
system is employed to capture the 3-dimensional shape of the
amputee's residual limb 15. For example, when the multiple-image
detector shape capture device described in U.S. patent application
Ser. No. 10/641,895 is employed, a special pattern imposer is
typically placed over the residual limb and the shape capture
device is properly oriented thereto. The pattern imposer may be of
various thickness, depending largely on the anatomy and physiology
of the residual limb to be scanned, and the medical device to be
constructed from the scanned data. The use of pattern imposers of
different thickness is explained in detail in a U.S.
continuation-in-part patent application filed in the name of Greg
Pratt on Oct. 07, 2003, and entitled A Medical Socket Contour
Scanning System, which application is hereby incorporated by
reference herein. The pattern imposer may be further landmarked by
the practitioner to indicate areas on the residual limb of
particular interest. These landmarks will allow such areas to be
more easily located on the subsequently generated electronic
model(s). The multiple-image detector shape capture device, or
other shape capture device, is commonly connected to a laptop
computer that is loaded with the design software that determines
the numeric data defining the shape of the residual limb,
optionally, allows for the conversion of the captured residual limb
shape into a 3-dimensional electronic model 20 thereof, and allows
for the generation of a 3-dimensional electronic liner model 45.
Other processing devices may also be used for this purpose, such
as, for example, a desktop computer, a pen computer, a pocket
personal computer (pocket PC), or a personal data assistant (PDA).
Alternatively, it is also contemplated that the captured image
could simply be converted into numerical data by a processor that
is integrated into the shape capture device and thereafter stored
on an acceptable storage medium for later conversion into a
3-dimensional model. In any event, once the practitioner is
satisfied that the shape capture procedure was properly completed,
the next step of the process may be embarked upon.
[0032] Assuming that the captured shape of the residual limb has
been acceptably converted into numeric data, the practitioner need
not necessarily do any more than subsequently furnish the data
associated therewith to the liner manufacturer 25. In such a case,
the interior of the liner will be made to conform to the captured
shape of the residual limb and will be of some default, and
substantially uniform, thickness. However, most likely, the
practitioner will want to modify the model 30 to account for
nuances of the particular residual limb in question and/or of the
particular prosthetic socket with which the liner will be worn.
Hence, a 3-dimensional electronic model of the residual limb will
typically be generated 20 to allow the practitioner (or other
qualified user of the system) to view the shape of the residual
limb and make changes thereto 30. For example, the practitioner may
desire an overall general thickness for the liner, which may
correspond to, for example, a global reduction in the size of the
residual limb model. Other modifications to the shape of the
residual limb model 30 may also be made, such as, without
limitation, those to account for particular scarring of the
residual limb, those to provide additional liner material around
protrusions or bony areas of the residual limb, and those to
provide areas of relief around particular other features of the
residual limb. When the liner will be worn by a BK amputee, the
practitioner may also manipulate the model in the area of the
patella tendon to ensure that the knee is properly supported but
allowed to flex adequately.
[0033] The software allows the data associated with the captured
shape of the residual limb to be used in producing a 3-dimensional
electronic liner model 45. The data may be unmodified, or may be
modified by a practitioner, as described above. Either way, the
residual limb model (if generated) is used to help define the
interior geometry of the liner. If no residual limb model is
generated, the captured residual limb shape data may be used
directly in the generation of the liner model. From such data, a
3-dimensional electronic liner model may be generated 45. As stated
above, the practitioner can specify an overall liner thickness.
Distal end liner thickness may be separately specified, such as to
provide extra cushioning to the often sensitive distal end of the
residual limb. Similarly, posterior liner thickness may be altered
over a user specified region to allow for a more unencumbered and
comfortable bending of the knee, or to provide hamstring relief.
Likewise, liner thickness may be altered in other areas, such as to
provide extra cushioning along the anterior portion of the residual
limb. In one embodiment of the present invention, the software also
permits the practitioner to select options and features of the
liner. For example, the practitioner may specify for inclusion
in/on the liner, options or properties such as: different types of
suspension components and their size, location and orientation;
bladders (including inflatable bladders) and their location and
size; liner materials and material properties, including hardness,
elasticity; the inclusion of additives, such as anti-microbials, in
the liner material; liner cover properties; and, sensors and their
type and location. Liner material options can include, without
limitation, polymer materials such as silicone, urethane,
thermoplastic elastomers (especially styrenic block copolymers), or
combinations thereof. Once the practitioner has selected all the
desired parameters, a final 3-dimensional electronic liner model is
preferably generated and made available for viewing 45.
[0034] In addition to the optional modification 30, 45 of the
3-dimensional model(s), it is also contemplated that the system and
method of the present invention may be used in conjunction with an
automated medical device configuration and purchasing system 35.
Such a system, its method of use, and a computer program for
operating the system, are disclosed in U.S. patent application Ser.
No. 09/893,535, entitled System, Method, And Computer Program
Product For Configuring And Purchasing A Medical Device, which is
hereby incorporated by reference herein. U.S. patent application
Ser. No. 09/893,535 teaches a system and method that allows a
prosthetist to substantially automatically configure one or more
medical devices based on inputted patient information. The system
is able to configure multiple embodiments of an acceptable device,
such as, for example, a "good," "better," and "best" alternative,
or the lightest or least expensive alternative. Thus, in
conjunction with ordering a custom liner, the system and method of
the present invention may also allow for the simultaneous
configuration and/or ordering of other prosthetic components or a
complete prosthetic device. For example, a prosthetic device for
use with the custom liner may be ordered at the same time as the
custom liner. The software (program) associated with the medical
device configuration and purchasing system may separately reside on
the processing device used in the shape capture process, or may be
accessible via connection to a server or over the Internet. In one
exemplary embodiment of the present invention, an interface or some
other means of communication between the two programs and systems
is provided, so that data may be shared and used between/by both
systems.
[0035] Once the practitioner is satisfied with the residual limb
model and/or the liner model, the data associated therewith must be
furnished to a manufacturing facility 25 that is equipped to
receive the data and to produce a liner therefrom. In addition, in
one embodiment of the present invention, it is possible that prior
to transmission to the manufacturing facility, the data may be
optionally converted 40 by the modelling software associated with
the shape capture system, or by associated software, into a format
that can be directly used by a computer-controlled machining
center, or another similar device. It is contemplated that the
data, in whatever format, may be furnished to the manufacturing
facility 25 in virtually any manner. Obviously, the data could be
delivered in person by the practitioner, or some other person
acting on behalf of the practitioner. In such case, it should be
understood that the data may be stored and provided on virtually
any machine readable medium, including, but not limited to, a
floppy disk, a compact disc or other optical medium, a
magneto-optical disk, a magnetic tape, a PROM or similar other
magnetic chip, a punch card, or a paper tape. It is only required
that the manufacturing facility is able to read the data from the
particular medium, or have the data transferred from the particular
medium employed to a medium readable by the facility.
[0036] Alternatively, the data associated with the residual limb
model and/or the liner model can be provided to the manufacturing
facility remotely. For example, the software may store the data in
the temporary memory of a desktop computer, laptop computer, pen
computer, pocket personal computer (pocket PC), or PDA, or on a
readable/writable storage medium associated with any thereof. At
some point thereafter, the practitioner can transmit the data to
the facility via any number of means, including, but not limited
to, by wired or wireless transmission over the Internet, or by
direct transfer from machine to machine (such as, for example, from
a laptop computer to another computer, or to a CNC or similarly
controlled machining device). Therefore, it should be understood
that the device used to remotely transfer the data to the
manufacturing facility may be equipped with any number of data
transmission components, such as, for example, a dial-up modem, a
DSL or ISDN modem, a cable modem, a WiFi card, a Bluetooth.RTM.
card, a WCDMA card, a network interface card (NIC), or a wireless
networking card. In yet another embodiment of the present
invention, it is possible that an amputee may visit a manufacturing
facility that employs its own qualified practitioner, or allows for
its use by outside practitioners. In this case, it is possible that
once collected/generated, the data associated with the residual
limb/liner model may be transferred from one computer, server,
database or other storage means to another similar or different
storage means of the facility via a wired connection, or by using
any of the aforementioned transmission means and devices to
transmit the data over, for example, a local area network (LAN) or
wireless local area network (WLAN). Via any of the aforementioned
data transfer means, it is also possible for the facility to
provide the data to another similar facility, or to virtually any
other entity that is involved with the liner manufacturing process
or that otherwise has a need for the information.
[0037] In an embodiment of the present invention alternative to
that described above, a more rudimentary and conventional method
may be used to capture the shape of an amputee's residual limb. For
example, if a practitioner does not have access to an electronic
shape capture system, the shape of the residual limb could still be
captured via a more conventional method, such as plaster casting or
tape measurement. The plaster cast or the measurements could then
be converted to an electronic model of the residual limb by the
practitioner, another practitioner, or the manufacturer. For
example, the plaster cast could be provided to the manufacturer for
electronic shape capture. The electronic liner model can then be
designed from an electronic model of the residual limb generated
from the subsequent electronic shape capture process, or from the
residual limb measurements. Also, the practitioner could design the
liner directly without capturing or creating a model of the shape
of the residual limb. For instance, a generic liner shape could be
selected from an electronic library of initial liner shapes based
on some minimal shape data associated with the amputee's residual
limb (e.g., a few circumference and length measurements). The
electronic generic liner shape could then be modified to form a
custom liner shape. While this method would not generally be as
accurate as designing the liner from a model of the residual limb,
it may be an acceptable approach if, for instance, a small
modification of an amputee's already existing liner is all that is
required.
[0038] Once the data is received by the manufacturing facility 50,
it can be used to initiate the liner manufacturing process. In an
exemplary embodiment of the present invention, the data is used by
a machining or carving device, such as, for example, a CNC
machining device, to produce a 3-dimensional positive likeness 55
that corresponds in size and shape to the computer generated and,
optionally, user-modified 3-dimensional electronic model of the
residual limb. The data may be modified at the manufacturing
facility 60 prior to being provided to the machining or carving
device. The 3-dimensional positive likeness will serve as the
custom mold core in the subsequent liner molding process. Any
number of acceptable machining devices are available for this
purpose and, although machining devices designed specifically for
the prosthetics industry exist, the use of such is not required. It
is also contemplated that other devices and methods commonly
employed to produce 3-dimensional models may also be used to create
the positive likeness. As previously mentioned, the data may have
been converted 40 into a form acceptable to the particular
machining device to be used prior to being furnished to the
manufacturing facility. However, if data conversion is necessary,
it is also possible that conversion is accomplished by software
associated with the machining device itself or by some intermediary
software or other electronic conversion means, after the data is
received by the manufacturing facility 60. The 3-dimensional
positive likeness/mold core may be produced from a number of
materials. Preferably, however, the 3-dimensional positive
likeness/mold core is produced from a material that is inexpensive,
that is lightweight, that can be quickly machined or otherwise
shaped, and that is of sufficient strength and durability to
withstand the molding process. In one particular embodiment of the
present invention, the 3-dimensional positive likeness/mold core is
machined from a closed-cell foam material.
[0039] Once the custom mold core has been produced, a mold cavity
is selected 65 for use therewith in the subsequent liner molding
process. In one exemplary embodiment of the present invention, the
custom mold core is used in conjunction with an existing, or
common, mold cavity, to produce the liner. For example, a mold
cavity used to produce Applicant's generic Alpha.RTM. liners
described above, may be used in cooperation with the custom mold
core to produce a custom prosthetic liner. In such a case, the mold
cavity is selected based only on its size. That is, a mold cavity
is selected that best corresponds to the size of the custom mold
core and/or the custom liner to be produced. For example, there may
be several generic mold cavities corresponding to various sizes of
off-the-shelf liners. The custom mold core is assembled to the mold
cavity 70, and the liner material is subsequently molded
therebetween to form the custom liner 75. In this manner, the
inside surface of the custom liner is imparted with the particular
characteristics of the residual limb that are embodied in the
custom mold core, while the outside of the custom liner is
simultaneously provided with a substantially uniform and smooth
surface for easy fitting into a prosthetic socket.
[0040] In another embodiment of the system and method of the
present invention, a custom mold cavity can be used with an
existing, or common, mold core. In yet a different embodiment, both
a custom mold core and a custom mold cavity can be manufactured.
The same data used to manufacture the custom mold core (based on
the 3-dimensional likeness of the residual limb) can be used to
manufacture the custom mold cavity. For example, the model defined
by the data can be expanded to manufacture a mold cavity of an
appropriate size to produce a liner of desired thickness when used
in conjunction with a common (or existing) or custom mold core.
While these alternative embodiments of liner manufacture would
likely be more costly than the embodiment that uses a generic, or
common, mold cavity, it is understood that the cost can be at least
somewhat reduced by manufacturing the custom mold core and/or
cavity from a low-cost material. For example, as the custom mold
cavity likely will not be used to produce a significant number of
liners, a softer, less wear-resistant, and easier to machine
material than would typically be used may be employed therefor.
[0041] Once the custom liner(s) is produced, it may be picked up or
delivered to the patient or to a practitioner. For example, if the
custom liner is new to the patient, it may be preferable that the
liner be initially provided to a practitioner to ensure that the
fit to the residual limb and prosthetic socket is adequate. If a
prosthetic device was ordered along with the liner, such as through
the automatic configuration and purchasing system described above,
both products can be simultaneously provided to the patient or
practitioner. In such a case, it may be possible for the liner
manufacturer to check the fit of the liner to the prosthetic socket
prior to delivery--assuming, of course, that the liner manufacturer
also manufactures or assembles the prosthetic device (or at least
the socket portion thereof), or otherwise obtains the prosthetic
device before providing the amputee with the custom liner.
[0042] Once the liner(s) is produced, the data associated therewith
is preferably stored for later use should, for example, the amputee
or practitioner wish to order an additional liner(s). The data may
be stored in a variety of ways, including, for example, on any of
the computer readable medium described above, on a computer hard
disk, or in a server database. Preferably, the liner data is saved
along with patient identifying information, thereby allowing for
quick location of, and access to, the liner data, should another
liner need to be made. In one embodiment of the system and method
of the present invention, the liner data and patient information
may be saved to the central database described in U.S. patent
application Ser. No. 09/893,535. In this case, the liner data and
patient information may thereafter be accessed as described in U.S.
patent application Ser. No. 09/893,535 with respect to the
patient-specific information used to configure and purchase a
medical device. The liner data may be stored in one or more forms.
For example, the liner data may be stored in a form used by the
liner modelling software, and/or in a form that is used by a
computer-controlled machining tool.
[0043] If the storage space is available, it is preferred that the
custom mold core be saved for possible later use. As the custom
mold core will generally be of very light weight and relatively
compact size, an inordinate amount of storage space should not be
required. Preferably, the custom mold core is stored in a manner
that allows for easy identification and quick retrieval. For
example, storage location data may be saved along with the liner
and/or patient data. This permits for a quicker turnaround of a
previously-produced liner upon receipt of a new order. It is
contemplated that a storage and retrieval system for storing and
working with existing custom mold cores may be operated manually,
or may be an automated system. For example, in the former
embodiment, a worker may simply retrieve a mold core from a
specified location, by any commonly used means. In the latter
embodiment, an automated mold core retrieval system may employed,
whereby a mold core retrieval device can automatically retrieve a
desired mold core based on storage information received from a data
storage location. Usable automated storage and retrieval systems
are well known, and need not be described in detail here. Storage
and retrieval of a custom mold core may be automatically
accomplished as a result of a signal generated by the system of the
present invention upon completion of a liner order, or upon receipt
of a new liner order. When a custom mold cavity is also
manufactured, it may be stored in the same manner as the custom
mold core. Alternatively, of course, the custom mold core may be
destroyed after the initial liner order is completed. In this case,
a new mold core must be produced from the respective stored data
should another liner be ordered by the patient or a
practitioner.
[0044] In another embodiment of the system and method of the
present invention, it is possible to produce a custom liner that
allows an amputee to continue using a prosthetic device even after
a change in the shape and/or size of the amputee's residual limb
negatively affects its fit with the prosthetic socket of the
device. This is a well known problem in the field of prosthetics,
and changes in the shape of a residual limb are not
uncommon--especially over a short term period following the initial
amputation. As discussed above, the fit of the residual limb to the
prosthetic socket of a prosthetic limb is critical to the comfort
of the amputee and to the proper use of the prosthetic limb. Thus,
prosthetic sockets are custom-constructed to fit the residual limb
of an individual amputee. However, if the shape and/or size of the
residual limb changes at some point after the initial construction
and fitting of the prosthetic socket, the prosthetic limb may
become unusable, or at the very least, uncomfortable. Typically,
the residual limb will shrink over time, particularly for some
period after the initial amputation. Consequently, the prosthetic
socket will often become loose on the residual limb, thereby
causing inadequate retention of the residual limb, and possible
discomfort to the amputee. If the change in the shape and/or size
of the residual limb is significant enough, the amputee may no
longer be able to wear the prosthetic limb as constructed, and a
new prosthetic socket will have to be made and installed thereto.
This can be both a time consuming and costly process, as a custom
prosthetic socket can be one of the most costly individual
components of a prosthetic limb.
[0045] The system and method of the present invention can be used
to allow an amputee with a residual limb of changed shape and/or
size to continue using his/her existing prosthetic socket. In this
process, 3-dimensional images of the current shape of the residual
limb are captured 15 by any of the means described above. In
addition, however, the interior of the amputee's current prosthetic
socket is also scanned or otherwise digitized 80 to obtain its
3-dimensional shape. This can be accomplished by using any of the
aforementioned techniques. As also described previously, a
3-dimensional model of the residual limb may be produced from the
captured shape 20 and, as previously described, may be modified by
a user of the system 30. In addition, a 3-dimensional model of the
prosthetic socket interior may be optionally generated 85 for
viewing or, alternatively, the data corresponding to the prosthetic
socket interior can simply be used (without generation of a
viewable model) by the liner modelling software to determine the
difference in size between the surface of the residual limb and the
interior of the prosthetic socket. In this manner, the thickness of
the subsequently-produced custom liner can be automatically
calculated 90 and specified by the modelling software to account
for the excess space between the residual limb and the prosthetic
socket interior. The practitioner is preferably still able to make
modifications to the 3-dimensional model of the residual limb, if
optionally generated, in order to adjust the resulting liner--as
the modelling software is able to determine the difference between
the modified model and the interior of the prosthetic socket.
Consequently, the interior of the resulting liner will be
customized to accommodate the particular features of the amputee's
residual limb, as described above, while the thickness of the liner
will account for the space that now exists between the interior of
the prosthetic socket and the surface of the residual limb. Once
the liner thickness is calculated, a 3-dimensional electronic model
of the liner is preferably displayed for viewing by the user of the
system 95. As in the aforementioned embodiment, the user may be
able to specify liner parameters and select options and/or
accessories to be installed to/in the liner. As described in more
detail above, the liner data is then sent to a manufacturing
facility 25 for use in molding the custom prosthetic liner 75.
Therefore, a custom liner can be efficiently and cost-effectively
produced by this embodiment of the system and method of the present
invention, which liner will allow the amputee to continue wearing
his/her prosthetic limb even after a change in the shape and/or
size of the amputee's residual limb.
[0046] In yet another embodiment of the system and method of the
present invention, it is possible to produce a custom liner that
will permit an amputee to wear a prosthetic limb having a generic
prosthetic socket (i.e., a socket with a generic interior shape).
The system and method employed in this embodiment is largely the
same as described above. However, in this embodiment, a generic
socket is also selected and a custom prosthetic liner is designed
to allow the residual limb of the amputee to fit properly therein.
It is contemplated that a series of generic prosthetic sockets can
be provided, from which the most appropriate socket can be
selected. Each of the series of generic sockets would differ
primarily only in size, as is required to accommodate residual
limbs of various size.
[0047] The system and method of the present invention can be used
to capture the interior shape of each generic socket, as described
above. Alternatively, the interior shape of the generic socket may
be known from data developed/used in the manufacturing thereof.
Thus, in a similar manner to the aforementioned process of
producing a custom liner that allows an amputee with a residual
limb of changed shape and/or size to continue using an existing
prosthetic socket, a custom liner may be produced with an interior
configuration customized to fit the residual limb of an individual
amputee and an exterior designed to fit properly within a
preselected generic prosthetic socket.
[0048] This particular embodiment of the present invention is
accomplished, in conjunction with other already-described aspects
of the system and method of the present invention, by having a
practitioner initially select the one of a series of generic
sockets that is most appropriately sized to generally fit the
amputee's residual limb 100. The 3-dimensional shape of the
amputee's residual limb is captured 15 and a 3-dimensional model
may be optionally produced therefrom 20--by any of the techniques
previously described. In this embodiment of the present invention,
it is also necessary to know the 3-dimensional shape of the
interior of the generic prosthetic socket. Thus, in one version of
this embodiment, the interior of the generic prosthetic socket is
also scanned, digitized 105 or otherwise analyzed to capture its
3-dimensional shape. It is also possible that the shape of the
generic socket interior may be known from data developed/used in
the manufacturing thereof. In such a case, capturing the shape of
the generic socket interior is not necessary. A 3-dimensional
electronic model of the generic socket interior can be optionally
generated 110 for viewing by the user of the system. The
3-dimensional model of the residual limb may again be modified if
desired 30, to assist in creating a liner of proper fit. Once any
adjustments to the optional 3-dimensional model of the residual
limb have been completed by the practitioner, the modelling
software uses the data associated with both the residual limb shape
and the interior of the generic prosthetic socket to globally
and/or locally calculate the thickness of the liner 115 as required
to ensure that its exterior will properly fit within the
preselected generic prosthetic socket when the liner-covered
residual limb is inserted therein. Once the liner thickness is
calculated, a 3-dimensional electronic model of the liner is
preferably displayed for viewing by the user of the system 120. As
in the aforementioned embodiment, the user may be able to specify
liner parameters and select options and/or accessories to be
installed to/in the liner. As described in more detail above, the
liner data is then sent to a manufacturing facility 25 for use in
molding the custom prosthetic liner 75. It is contemplated that the
generic prosthetic socket may be selected automatically by the
modelling software based on the captured shape/size of the residual
limb, may be specified by the practitioner, or may be selected from
a database of generic sockets available as part of the
aforementioned optional medical device configuring and purchasing
system. The system and method of this embodiment of the present
invention facilitates the construction of a prosthetic limb having
a generic socket, while still providing a fit that is customized to
an individual amputee. Hence, this embodiment of the system and
method of the present invention permits the construction of a
custom-fit prosthetic limb in less time, and at a reduced cost.
[0049] While certain embodiments of the present invention are
described in detail above, the scope of the invention is not to be
considered limited by such disclosure, and modifications are
possible without departing from the spirit of the invention as
evidenced by the following claims:
* * * * *