U.S. patent application number 14/302197 was filed with the patent office on 2015-08-13 for method of manufacturing a structurally encoded implantable device.
The applicant listed for this patent is Brian Kieser. Invention is credited to Brian Kieser.
Application Number | 20150223899 14/302197 |
Document ID | / |
Family ID | 53763092 |
Filed Date | 2015-08-13 |
United States Patent
Application |
20150223899 |
Kind Code |
A1 |
Kieser; Brian |
August 13, 2015 |
METHOD OF MANUFACTURING A STRUCTURALLY ENCODED IMPLANTABLE
DEVICE
Abstract
An implant device identifiable after implantation comprises a
main portion of the implant device and a coded portion of the
implant device. The coded portion comprises a radiopaque element
and indicia on the radiopaque element or indicia as a plurality of
radiopaque elements disposed within the coded portion. The indicia
are discernible by x-ray, fluoroscopy, computed tomography,
electromagnetic radiation, ultrasound, or magnetic resonance
imaging.
Inventors: |
Kieser; Brian; (San Antonio,
TX) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Kieser; Brian |
San Antonio |
TX |
US |
|
|
Family ID: |
53763092 |
Appl. No.: |
14/302197 |
Filed: |
June 11, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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61938475 |
Feb 11, 2014 |
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Current U.S.
Class: |
264/308 |
Current CPC
Class: |
G06K 1/121 20130101;
A61F 2250/0097 20130101; A61F 2250/0086 20130101; G06K 2019/06253
20130101; A61B 8/0841 20130101; G06K 2215/0097 20130101; G06K
19/06121 20130101; H05K 999/99 20130101; A61F 2/442 20130101; A61B
90/96 20160201; A61B 17/8625 20130101; A61B 17/866 20130101; A61B
6/4494 20130101; A61F 2250/0089 20130101; G06K 2019/06271 20130101;
A61B 90/90 20160201; A61F 2250/0098 20130101; G06K 19/06 20130101;
G06K 7/10 20130101; A61B 90/39 20160201; G06K 7/1099 20130101; B33Y
80/00 20141201; A61F 2/02 20130101; A61B 6/12 20130101; A61B
17/7004 20130101; B29L 2031/7532 20130101; B29K 2995/0056 20130101;
A61B 2090/3966 20160201; A61B 17/80 20130101 |
International
Class: |
A61B 19/00 20060101
A61B019/00; G06K 1/12 20060101 G06K001/12; B29C 67/00 20060101
B29C067/00 |
Claims
1. A method of manufacturing an identifiable implant device,
comprising: printing a first material onto a first surface to
create a first printed layer, printing said first material onto
said first printed layer to create a second printed layer, wherein
at least one of said printing said first material onto said first
surface and said printing said first material onto said first
printed layer comprises printing encoded indicia.
2. The method of claim 1, wherein said encoded indicia comprise
voids in said first material.
3. The method of claim 1, further comprising: printing a second
material onto at least one of said first surface and said first
printed layer, such that said encoded indicia comprises said second
material.
4. The method of claim 1, wherein said encoded indicia are
discernible by at least one of x-ray, fluoroscopy, computed
tomography, electromagnetic radiation, ultrasound, and magnetic
resonance imaging.
5. The method of claim 4, wherein said encoded indicia contain
unique data referencing additional information located in an
external database.
6. The method of claim 5, wherein said additional information
comprises at least one of medical information, procedure
information, implant information, healthcare professional
information, and healthcare facility information.
7. The method of claim 4, wherein said encoded indicia comprise
self-contained data including at least one of medical information,
procedure information, implant information, healthcare professional
information, and healthcare facility information.
8. The method of claim 4, wherein said encoded indicia comprise
information in the form of a code.
9. The method of claim 8, wherein said code comprises a means for
at least one of error detection and correction.
10. The method of claim 8, wherein said code comprises a means for
data compression.
11. The method of claim 1, wherein said implant device comprises a
second material different from said first material.
12. A method of manufacturing an identifiable implant device,
comprising: printing a first material onto a first surface to
create a first printed layer, printing a second material onto said
first printed layer to create a second printed layer, wherein at
least one of said printing said first material onto said first
surface and said printing said second material onto said first
printed layer comprises printing encoded indicia.
13. The method of claim 12, wherein said encoded indicia comprise
voids in at least one of said first material and said second
material.
14. The method of claim 12, wherein said encoded indicia are
discernible by at least one of x-ray, fluoroscopy, computed
tomography, electromagnetic radiation, ultrasound, and magnetic
resonance imaging.
15. The method of claim 14, wherein said encoded indicia contain
unique data referencing additional information located in an
external database.
16. The method of claim 15, wherein said additional information
comprises at least one of medical information, procedure
information, implant information, healthcare professional
information, and healthcare facility information.
17. The method of claim 14, wherein said encoded indicia comprise
self-contained data including at least one of medical information,
procedure information, implant information, healthcare professional
information, and healthcare facility information.
18. The method of claim 14, wherein said encoded indicia comprise
information in the form of a code.
19. The method of claim 18, wherein said code comprises a means for
at least one of error detection and correction.
20. The method of claim 18, wherein said code comprises a means for
data compression.
21. The method of claim 12, wherein said second material comprises
said first material having a variation in a physical property.
22. The method of claim 21, wherein said variation in a physical
property comprises a different density.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to methods of manufacturing
identifiable implants and, in particular, methods of manufacturing
a structurally encoded implant device.
BACKGROUND OF THE INVENTION
[0002] Medical implant devices used in surgical procedures can be
associated with particular information to guide medical
professionals before and after the surgical procedure. Each implant
device carries a wealth of information that is valuable to the
patient, the implant manufacturer, medical researchers, healthcare
professionals, and medical facilities. However, the information,
which may include the implant manufacturer and manufacturer's lot
number, the date and location of surgical implantation, the
responsible surgeon, any medical notes, photographs, or diagrams
relating to the implant, surgery, or condition, may not be
adequate, properly recorded, or readily accessible for beneficial
use by a healthcare professional, implant manufacturer, or medical
researcher after implantation. Problems relating to poor implant
records can lead to unnecessary delay or even medical error by
healthcare professionals. Moreover, there are many different
implant identification methods currently in place instead of a
common system to allow manufacturers, distributors, and healthcare
facilities and professionals to effectively track, identify, and
manage implant devices and medical device recalls. The U.S. Food
and Drug Administration recently announced a program focusing on
requirements for unique device identifiers for every medical
implant device to address the need for a more robust implant device
identification system, the details of which are incorporated by
reference herein: www.fda.gov/udi.
SUMMARY OF THE INVENTION
[0003] In accordance with an aspect of the invention, an implant
device identifiable after implantation is provided comprising a
main portion of the implant device and a readable portion of the
implant device. The readable portion may comprise a radiopaque
element and indicia disposed on at least one surface thereof or
disposed within the implant. The indicia may include a plurality of
modifications to at least one surface of the radiopaque element or
a plurality of radiopaque elements disposed within the readable
portion such that the indicia are discernible by at least one of
x-ray, fluoroscopy, computed tomography, electromagnetic radiation,
ultrasound, and magnetic resonance imaging.
[0004] In accordance with further aspects of the invention, the
readable portion may be integral with the main portion. The
readable portion may also be disposed upon the main portion. The
plurality of modifications may include an array of holes in the at
least one surface of the radiopaque element. The plurality of
modifications may include an array of notches or variations of
density in the at least one surface of the radiopaque element. The
array of notches in the at least one surface of the radiopaque
element may form at least one bar code. The at least one bar code
may comprise a Hamming code. The plurality of modifications may be
less than or equal to two centimeters in length.
[0005] In accordance with further aspects of the invention, a
system for identifying an implantable device is provided comprising
an implantable device comprising a main portion and a readable
portion. The readable portion may comprise a radiopaque element and
indicia disposed on at least one surface thereof. The indicia may
include a plurality of modifications to at least one surface of the
radiopaque element or a plurality of radiopaque elements disposed
within the readable portion. The indicia may further include a
database containing a plurality of records associated with a
plurality of implantable devices and a user interface comprising
means for displaying information associated with the indicia based
on the plurality of records. The indicia may be discernible by at
least one of x-ray, fluoroscopy, ultra-sound computed tomography,
electromagnetic radiation, ultrasound, and magnetic resonance
imaging.
[0006] The plurality of modifications may include an array of holes
in the at least one surface of the radiopaque element. The
plurality of modifications may include an array of notches in the
at least one surface of the radiopaque element. The array of
notches in the at least one surface of the radiopaque element may
form at least one bar code. The at least one bar code may comprise
a Hamming code.
[0007] In accordance with further aspects of the invention, a
method of identifying a micromanufactured implant device is
provided comprising discerning indicia by at least one of x-ray,
fluoroscopy, computed tomography, electromagnetic radiation,
ultrasound, and magnetic resonance imaging. The indicia may include
a plurality of modifications to at least one surface of a
radiopaque element or a plurality of radiopaque elements disposed
within a readable portion. The method of identifying a
micromanufactured implant device may further comprise accessing a
plurality of records associated with at least one of a plurality of
implantable devices and providing information associated with the
micromanufactured implant based on the indicia and the plurality of
records. As used herein, the term "micromanufactured" encompasses
all microfabrication techniques such as additive manufacturing and
micromachining, and use of this term is not intended to limit the
size or scale constraints or the type of the manufacturing process
in any way. The term is used to elucidate the desire for the
detectable portion of the implant device of the present invention
to be either an incorporated portion of an implant or of a size
capable of being implanted.
[0008] In accordance with further aspects of the invention, the
method of identifying a micromanufactured implant device may
further comprise displaying information associated with the
micromanufactured implant based on the indicia and the plurality of
records through a user interface. The readable portion may be
disposed upon a main portion of the micromanufactured implant
device. The plurality of modifications may include an array of
holes in the at least one surface of the radiopaque element. The
plurality of modifications may include an array of notches in the
at least one surface of the radiopaque element. The array of
notches in the at least one surface of the radiopaque element may
form at least one bar code. The at least one bar code may comprise
a Hamming code or other similar methods for error detection and
correction that are known in the coding theory art. Additionally,
data compression may be used in the coded indicia of the preferred
embodiment.
[0009] In accordance with further aspects of the invention, an
implant device identifiable after implantation is provided
comprising a main portion of the implant device and a readable
portion of the implant device. The readable portion may comprise a
plurality of laminae or laminar planes (a finite planar volume).
Each of the laminae, hereafter referred to as "laminar planes," may
comprise separately readable indicia such that the indicia may be
discernible in three dimensions by at least one of x-ray,
fluoroscopy, computed tomography, electromagnetic radiation,
ultrasound, and magnetic resonance imaging.
[0010] The readable portion may be integral with the main portion.
Also, the readable portion may be disposed upon the main portion.
Further, the indicia may include an array of voids on or in a
corresponding laminar plane of the readable portion. The indicia
may include an array of embedded markers on or in a corresponding
laminar plane of the readable portion. The embedded markers may
comprise a modulation of material compositions such that a first
material composition of at least one first embedded marker is
different than a second material composition of at least one second
embedded marker. Further, the indicia may include a first array of
embedded markers on or in a first laminar plane of the readable
portion and a second array of embedded markers on or in a second
laminar plane of the readable portion. The first array may comprise
a first embedded marker having a first material composition
different than a second material composition of a second embedded
marker disposed in the second array. The indicia may comprise
information in the form of a code. The code may comprise a Hamming
code or other similar methods for error detection and correction
that are known in the coding theory art. Additionally, data
compression may be used in the coded indicia of the preferred
embodiment.
[0011] In accordance with further aspects of the present invention,
a method of manufacturing an identifiable implant device is
provided comprising providing a main portion of the implant device,
providing a readable portion of the identifiable implant device,
printing a first material onto a first readable portion surface to
create a first printed layer, and printing the first material onto
the first printed layer to create a second printed layer. The
printing of the first material onto the first readable portion
surface or the printing of the first material onto the first
printed layer may comprise printing encoded indicia. The encoded
indicia may comprise voids in the first material or measurable
variations in density. The method of manufacturing an identifiable
implant device may further comprise printing a second material onto
at least one of the first readable portion surface and the first
printed layer, such that the encoded indicia comprises the second
material.
[0012] In accordance with further aspects of the present invention,
an implant device identifiable after implantation is provided
comprising a main portion of the implant device and a readable
portion of the implant device. The readable portion comprises an
internal structure inside the readable portion. The internal
structure comprises a plurality of linking structures. Each of the
linking structures has a predetermined size or orientation. The
linking structures are interconnected to substantially form the
internal structure. The linking structures form predetermined
indicia such that the indicia are discernible by x-ray,
fluoroscopy, computed tomography, electromagnetic radiation,
ultrasound, and/or magnetic resonance imaging. The readable portion
may be integral with the main portion or disposed upon the main
portion. The indicia in the readable portion of the implant device
may comprise a Hamming code or other similar methods for error
detection and correction that are known in the coding theory art.
Additionally, data compression may be used in the coded indicia of
the preferred embodiment.
BRIEF DESCRIPTION OF THE FIGURES
[0013] While the specification concludes with claims particularly
pointing out and distinctly claiming the present invention, it is
believed that the present invention will be better understood from
the following description in conjunction with the accompanying
Drawing Figures, in which like reference numerals identify like
elements, and wherein:
[0014] FIG. 1 is a side perspective view of a micromanufactured
identifiable implant device in accordance with aspects of the
present invention;
[0015] FIG. 2 is a side perspective view of a micromanufactured
identifiable implant device in accordance with further aspects of
the present invention;
[0016] FIG. 3 is a side perspective view of a micromanufactured
identifiable implant device in accordance with further aspects of
the present invention;
[0017] FIG. 4 is a front perspective view of a micromanufactured
identifiable implant device in accordance with further aspects of
the present invention;
[0018] FIG. 5 is a front perspective view of a micromanufactured
identifiable implant device in accordance with further aspects of
the present invention;
[0019] FIG. 6 is a front perspective view of a micromanufactured
identifiable implant device in accordance with further aspects of
the present invention;
[0020] FIG. 7 is an enlarged cross sectional view of a
micromanufactured identifiable implant device in accordance with
further aspects of the present invention;
[0021] FIG. 7A is an enlarged cross sectional view of a
micromanufactured identifiable implant device in accordance with
further aspects of the present invention;
[0022] FIG. 8 is a diagram relating to indicia data of a
micromanufactured identifiable implant device in accordance with
further aspects of the present invention;
[0023] FIG. 8A is a diagram relating to indicia data of a
micromanufactured identifiable implant device in accordance with
further aspects of the present invention; and
[0024] FIG. 9 is a side perspective view of a micromanufactured
identifiable implant device in accordance with further aspects of
the present invention.
DETAILED DESCRIPTION
[0025] In the following detailed description of the preferred
embodiment, reference is made to the accompanying drawings that
form a part hereof, and in which is shown by way of illustration,
and not by way of limitation, a specific preferred embodiment in
which the invention may be practiced. It is to be understood that
other embodiments may be utilized and that changes may be made
without departing from the spirit and scope of the present
invention.
[0026] Reference is now made to FIG. 1, which shows an implantable
rod structure 10 having a series of notches 12 in one longitudinal
side 14 of the rod structure 10. The implantable rod structure 10
of the preferred embodiment of FIG. 1 features a readable portion
16 shown in FIG. 1 to be integral with a main portion 18 of an
implant device 20. Alternatively, the readable portion 16 of the
implant device 20 may be disposed upon the main portion 18 of the
implant device 20. The readable portion 16 may be coupled to the
main portion 18 by such means as fasteners or adhesives or through
interference fit. Each of the notches 12 is a modification to the
surface of the readable portion 16, has a predetermined width 22,
and is located at a predetermined axial position 24 so as to create
indicia 26 representing one-dimensional data. The rod structure 10
in the preferred embodiment is a radiopaque structure, such as a
tantalum rod. As will be further described below, the rod structure
10 may have a variable density such that the rod structure contains
indicia in the form of a variable density internal structure or a
particular mesh structure created by additive manufacturing,
thereby increasing the density of data coding. After implantation,
the rod structure 10 and indicia 26 are detectable and readable via
a variety of methods such as x-ray, fluoroscopy, computed
tomography, electromagnetic radiation, ultrasound, and magnetic
resonance imaging. The indicia 26 is detected and received by
conventional medical imaging devices. Imaging software, preferably
high resolution imaging software, then reads the data from the
indicia 26 to decode and store and/or display the information from
the implant device 20.
[0027] In a first embodiment of the present invention, the data
represented by the indicia 26 on the surface of the rod structure
10 references unique information located in an external database.
One example of such information includes data from the indicia
representing a unique numerical identifier corresponding to a
wealth of manufacturer, patient, surgeon, or surgical procedure
information located in an external healthcare facility
database.
[0028] In further embodiments of the present information, the size
of the indicia may be decreased, and the density of the data
thereby increased, such that additional information beyond mere
reference data may be recorded onto the surgical implant. Such
embodiments are further discussed below.
[0029] In the preferred embodiment of the present invention, error
correction is used to increase the resolution of the imaging
technology, thereby allowing an increase in data density. Error
correction is discussed in more detail below.
[0030] Referring now to FIG. 9, rod structure 310 includes a
plurality of threads 312 in a spiral or helical configuration
around the circumference of the rod structure 310. Although the
threads 312 shown in FIG. 9 are continuous to form a screw
structure, such as a pedicle screw, the inner diameter 314 between
adjacent threads 312 is varied to form indicia. As indicated in
FIG. 9, the predetermined indicia allow coded data to appear within
the functional structure of the rod structure 310 before and after
implantation. Alternatively, the outer diameter 316 of threads 312
may be varied in addition to, or instead of, the variation of the
inner diameter 314 to retain coded indicia on the rod structure
310. Further, the axial spacing 318 between adjacent threads 312
may be varied in order to store data. Even further, the particular
shape of the spacing between adjacent threads 312, such as a
square, triangular, or circular shape, may also allow data storage
in the rod structure 310. A variation of this embodiment includes a
micromanufactured implant device having indicia in or on the head
320 of the rod structure 310, such as coded indicia in the head of
a surgical screw.
[0031] Any of the embodiments, including each particular structure,
disclosed in the present application may include encoded implant
devices having the forms of, or being incorporated into, screws,
rods, or other medical devices such as shoulder implants, hip
implants, knee implants, or cardiovascular devices, stents, etc.
One such example of a structure and related method of the present
invention may be one or more structurally encoded tantalum rod(s)
in a PEEK interbody cage assembly.
[0032] Referring now to FIG. 2, an implantable rod structure 40 of
a preferred embodiment of the present invention features a series
of notches 42 around the circumference of the rod structure 40. The
implantable rod structure 40 of the preferred embodiment of FIG. 2
features a readable portion 44 shown in FIG. 2 to be integral with
a main portion 46 of an implant device 48. Alternatively, the
readable portion 44 of the implant device 48 may be disposed upon
the main portion 46 of the implant device 48. The readable portion
44 may be coupled to the main portion 46 by such means as fasteners
or adhesives or through interference fit. Each of the notches 42 is
a modification to an exterior surface 50 of the readable portion
44, has a predetermined width 52, and is located at a predetermined
axial position 54 so as to create indicia 56 representing
one-dimensional data. The rod structure 40 in the preferred
embodiment is a radiopaque structure, such as a tantalum rod. After
implantation, the rod structure 40 and indicia 56 are detectable
and readable via a variety of imaging methods such as x-ray,
fluoroscopy, computed tomography, electromagnetic radiation,
ultrasound, and magnetic resonance imaging. The notches 42 of the
preferred embodiment may be created using known lathe (machining)
techniques or through additive manufacturing processes, as further
discussed below. As opposed to indicia located only on a side of a
rod structure as shown in FIG. 1, positioning of indicia 56 around
the circumference of the rod structure 40, as shown in FIG. 2,
increases visibility of the indicia 56 and readability of the data
by imaging methods. The indicia 56 is detected and received by
medical imaging devices, which transmits the data to imaging
software with sufficient resolution for accurately resolving the
indicia. The imaging software reads the indicia 56 to decode and
store and/or display the information from the implant device
48.
[0033] Although the indicia 26 and 56 shown in FIGS. 1 and 2 is
oriented in a direction perpendicular to the axis of the rod
structures 10 and 40, the indicia of the rod structures 10 and 40
may be oriented in a skewed or slanted orientation such that the
indicia is not perpendicular to the axis of the rod structures 10
and 40. As will be recognized by one having ordinary skill in the
art, any embodiment of the exemplary rod structures shown in FIGS.
1-3 and 9 may include notches, threads, or similar surface
modification. Furthermore, each notch, thread, or similar structure
may vary in depth, cross-section, or geometric shape across the
series or array for further data storage.
[0034] With regard to the rod structures 10 and 40, one exemplary
use of the rod structures described in the present invention is in
spine fusion. The rod structures may be utilized in spinal cages
classified by the FDA as Cement Restrictors, Vertebral Body
Replacement Devices (VBR), or Interbody Fusion Devices (IBFD).
Another variation of the present invention is not limited to rod
structures used in spinal cages and may include the use of rod
structures in allograft bone and other implantable medical devices.
This embodiment of the implant device of the present invention may
include donor information such as tissue identification number,
donor number, or sterility information. As will be fully understood
by the present invention, such encoding can be accomplished quickly
before implantation.
[0035] In a preferred embodiment of the present invention, the data
represented by the indicia 56 on the surface of the rod structure
references unique information located in an external database. One
example of such information includes the data from the indicia 56
representing a unique implant number corresponding to a wealth of
manufacturer, patient, surgeon, or surgical procedure information
located in an external healthcare facility database.
[0036] Error correction is used in a preferred embodiment of the
present invention to increase the resolution of the imaging
technology, thereby allowing an increase in data density for a
given measurement technology. By encoding, for example, a number
into the implant through micro-machined holes and/or notches,
sufficient permutations of the code can be recorded. In a preferred
embodiment of an implantable device according to the present
invention, a tantalum marker used in polymer spine implants
contains, for one example, 400 micron discrete notches. The full
code width and the bit count could, in this example, be dictated by
machining precision and accuracy, number of variable machining
widths (e.g., 100 microns, 200 microns, and 300 microns), total bar
length, and image resolution. To ensure robustness in the encoding
scheme, error correction in the form of a Hamming code is
implemented in the preferred embodiment but any error correction
method known in the coding theory art could be employed. In the
preferred embodiment shown in FIGS. 1 and 2, four variable width
notches every 250 microns allow eight bits of data to be encoded
reliably every millimeter and read by a computed tomography scan
with sufficient resolution to identify the notches. This is an
example under the preferred embodiment having values that are
"power of 2 friendly" in order to clarify one embodiment of the
present invention. The specific values of any particular embodiment
of the present invention depend upon the imaging and manufacturing
resolution, which will improve over time, as one having ordinary
skill in the art may recognize.
[0037] Referring now to FIG. 3, an implantable rod structure 70 of
a preferred embodiment of the present invention features multiple
materials in discrete layers 72 to create one-dimensional data
around the circumference of the rod structure 70. The implantable
rod structure 70 of the preferred embodiment of FIG. 3 features a
readable portion 74 shown in FIG. 3 to be integral with a main
portion 76 of an implant device 78. Alternatively, the readable
portion 74 of the implant device 78 may be disposed upon the main
portion 76 of the implant device 78. The readable portion 74 may be
coupled to the main portion 76 by such means as fasteners or
adhesives or through interference fit. Similar to the notched
indicia shown in FIGS. 1 and 2, the variance of material across the
layers 72 in the embodiment shown in FIG. 3 creates indicia 80
representing data that is readable across the axial dimension of
the rod structure 70. Alternative embodiments may feature multiple
material layers readable across a different dimension or a
structure having a different shape constructed using layers of
multiple materials.
[0038] Referring again to the preferred embodiment of FIG. 3, each
of the distinct material layers 72 has a predetermined width 82 and
is located at a predetermined axial position 84 so as to create the
indicia 80 representing one-dimensional data. At least one of the
layers 72 in the rod structure 70 of FIG. 3 is a radiopaque
structure. In the preferred embodiment each of the layers 72 is
composed of a particular material having some degree of opacity.
Like the rod structures of FIGS. 1 and 2, after implantation, the
rod structure 70 and indicia 80 of the implant device 78 of FIG. 3
are detectable and readable via a variety of imaging methods such
as x-ray, fluoroscopy, computed tomography, electromagnetic
radiation, ultrasound, and magnetic resonance imaging. The indicia
layers 72 of the preferred embodiment shown in FIG. 3 are
structured so as to be visible from any side of the rod structure
70 to increase readability of the data by imaging methods. The
indicia 80 are detected and received by medical imaging devices,
which transmits the data to imaging software, preferably high
resolution imaging software. The imaging software reads the indicia
80 to decode and store and/or display the information from the
implant device 78.
[0039] The information or data encoded onto or into the implant
devices of the embodiments disclosed in the present invention may
be detected, decoded, read, transferred, stored, displayed, or
processed according to such methods and devices disclosed in U.S.
Pat. No. 8,233,967 or U.S. Patent Application Publication No.
2013/0053680, both of which are incorporated herein by
reference.
[0040] The implantable device 78 of FIG. 3 is manufactured using
additive manufacturing (AM) techniques. Due to their precision and
programmability, AM processes may be used for any of the
embodiments shown in FIGS. 1-3 to allow a reduction in the size of
the indicia and, therefore, increased density of data included onto
the surface of the implantable rod structure. In some cases,
machining may be sufficient to provide the indicia necessary for
the implantable rod structure. With increased data density,
additional information beyond mere reference data may be recorded
onto the surgical implant 78. The data recorded onto the implant
device itself may include the manufacturer, patient, surgeon,
healthcare facility, or surgical procedure information that would
otherwise need to be stored in and accessed through an external
database. Additionally, AM allows complex, mass customized,
internal structures otherwise unavailable with conventional
manufacturing, including three-dimensional structures discussed in
further detail below. Moreover, AM eliminates the need for tooling
and can therefore allow fabrication of implants with unique
identifiers within the structure with no additional masks, molds or
user interaction.
[0041] ASTM International formed Committee F42 on Additive
Manufacturing Technologies in 2009 with the mission of setting the
standards for design, process, and materials with regards to AM.
The committee defined a taxonomy of seven sub-technologies that
together constitute the full suite of AM techniques. The seven
sub-technologies are described in ASTM F2792-12a, the details of
which are incorporated by reference herein.
[0042] Material extrusion is an additive manufacturing process
where material is selectively dispensed through an extrusion
nozzle. The most common implementation of this method involves the
extrusion of thermoplastic material through a heated orifice. The
materials available for the most common implementation tend to be
functional plastics that are sufficiently robust to withstand harsh
environments such as chemical, mechanical, or temperature
exposure.
[0043] Vat photo polymerization features a vat of liquid photo
curable polymer that is selectively cured with an energy source
such as a laser beam or other optical energy. The part is typically
attached to a platform that descends one cure depth after a layer
is completed and the process is repeated. This class of additive
manufacturing benefits from feature sizes dictated by either the
laser beam width or optical resolution in the X and Y axis and
minimum cure depth in Z.
[0044] Powder bed fusion processes include selectively melting or
sintering a layer of powder using an energy source such as a laser
or electron beam, lowering the layer by a fabrication layer
thickness, and adding a new powder layer by delivery with a rake or
roller and material storage mechanism. The process continues with
the next layer. Unmelted powder in the bed acts inherently as
support material for subsequently built layers.
[0045] Material jetting uses ink-jetting technology to selectively
deposit the build material with a cure prior to the application of
subsequent layers. An exemplary version of this technology may be
ink-jetting multiple photo-curable polymers and follow the inkjet
head with a UV lamp for immediate and full volume curing. With
multiple materials, fabricated items can be multi-colored or
materials can be chosen with varying stiffness properties.
Ink-jetting is also naturally well suited for parallelism and thus
can be easily scaled to larger and faster production.
[0046] Binder jetting includes selectively ink-jetting a binder
into a layer of powder feedstock. Additional powder material is
then dispensed from a material storage location by a rake or roller
mechanism to create the next layer. Some binder jetting
technologies may require a post-anneal furnace cycle depending on
the materials being used (e.g., metals, ceramics). One exemplary
system may inkjet color (much like a commercial inkjet color
printer) in addition to the binder into a powder, and may therefore
provide structures with colors throughout the structure for
conceptual models. Another binder jetting system may utilize a post
anneal process to drive out the binder to produce metal or ceramic
structures.
[0047] Sheet lamination is another additive manufacturing process
in which individual sheets of material are bonded together to form
three-dimensional objects. In one exemplary embodiment, sheets of
metal are bonded together using ultrasonic energy. The process has
been shown to produce metallurgical bonds for aluminum, copper,
stainless steel, and titanium. A subsequent subtractive process
between layers adds internal structures and other complex
geometries impossible with conventional subtractive manufacturing
processes that start from a billet of material.
[0048] Directed energy deposition is another additive manufacturing
process that directs both the material deposition and the energy
source (typically a laser or electron beam) at the surface being
built. Directed energy deposition processes typically use powder or
wire-fed metals and exemplary applications of the process may
include repair of high value components used in aircraft
engines.
[0049] The implant device of the present invention may be
manufactured by conventional methods such as a machining operation
using any milling, lathe, or drilling operation to include standard
machining and fabrication methods known in the art of manufacturing
medical implants.
[0050] The embodiments of FIGS. 1-3 show an implantable rod
structure having a length of one centimeter. Exemplary embodiments
of each implant device shown in FIGS. 1-3 include each notch or
material variation having a thickness of 0.1-0.3 millimeters, which
results in storage of about 30-40 bits of information on the
implantable rod structure. After utilizing bits for Hamming code
error correction, about 25-35 actual data bits create approximately
30 million to 30 billion indexing options into an external database
or for limited information stored on the implant such as an implant
expiration date and lot number.
[0051] Referring now to FIG. 4, an implantable plate structure 100
of a preferred embodiment of the present invention features a
two-dimensional array of modifications 102 to a surface 104 of the
plate structure 100. The implantable plate structure 100 of the
preferred embodiment of FIG. 4 features a readable portion 106
shown in FIG. 4 to be integral with a main portion 108 of an
implant device 110. Alternatively, the readable portion 106 of the
implant device 110 may be disposed upon the main portion 108 of the
implant device 110. The readable portion 106 may be coupled to the
main portion 108 by such means as fasteners or adhesives or through
interference fit. The modifications 102 to the surface 104 of the
plate structure 100 shown in FIG. 4 are holes 112 that are
micromanufactured through the surface 104 of the plate structure
100. The plate structure 100 may be composed of any material such
as a metal, polymer, or ceramic compatible with the imaging
modality selected.
[0052] The preferred embodiment shown in FIG. 4 features a plate
structure 100 that is one centimeter squared and one millimeter
thick and has a seven-by-seven array of holes 112. The holes 112
are spaced about one millimeter from each other to provide 49 bits.
After subtracting bits used for error correction, approximately
four trillion reliable database entry fields with error correction
are provided by the seven-by-seven array of holes 112. A separate
database entry field for every human on Earth requires an
implantable device having 33 bits of data--sufficient to uniquely
identify over 8 billion cases. An additional eight bits is needed
if each person on Earth were allocated up to 256 implants each. A
Hamming code is implemented in the preferred embodiment of the
implantable device with an additional eight bits to provide for the
detection and correction of single bit errors.
[0053] Referring now to FIG. 5, an implantable plate structure 140
of a preferred embodiment of the present invention features a
two-dimensional array of embedded markers 142 located at an
internal plane 144 of the implantable plate structure 140. The
embedded markers 142 of the preferred embodiment are internal
volumes of a second material of different density. The implantable
plate structure 140 of FIG. 5 features a readable portion 146 shown
in FIG. 5 to be disposed upon a main portion 148 of an implant
device 150. Although not shown in FIG. 5, the readable portion 146
may be coupled to the main portion 148 by such means as fasteners
or adhesives or through interference fit. Alternatively, the
readable portion 146 of the implant device 150 may integral with
the main portion 148 of the implant device 150. The second material
having a different density than the plate structure shown in FIG. 5
may be a substance of any material phase including a solid, liquid,
or a gas. The embedded markers 142 as an array of internal volumes
of FIG. 5 may also be voids in the material of the readable portion
146 of the implantable plate structure 140. The implantable plate
structure 140 may be composed of any material such as a metal,
ceramic, or polymer.
[0054] Similar to the plate structure of FIG. 4, the preferred
embodiment shown in FIG. 5 features a plate structure 140 that is
one centimeter squared and one millimeter thick and has a
seven-by-seven array of internal volumes or voids forming embedded
markers 142. The volumes are spaced about one millimeter from each
other to provide 49 bits. After subtracting bits used for error
correction, four trillion reliable database entry fields with error
correction are provided by the seven-by-seven array of volumes or
voids. A separate database entry field for every human on Earth
requires an implantable device having 33 bits of data. An
additional eight bits is needed if each person on Earth were
allocated up to 256 implants each. A Hamming code is implemented in
the preferred embodiment of the implantable device with an
additional eight bits to provide for the detection and correction
of single bit errors.
[0055] Referring now to FIG. 6, an implantable structure 170 of a
preferred embodiment of the present invention features a
three-dimensional array 186 of embedded markers 176 located on a
series of internal planes 174 of the implantable structure 170 that
are separated across the z-axis of the implantable structure 170.
Each of the internal planes 174 shown in FIG. 6 comprise a
three-dimensional array of embedded markers 176. The embedded
markers 176 in the preferred embodiment are internal volumes of a
second material of differing density than a first material forming
the remainder of the implantable structure 170. The embedded
markers 176 may additionally be composed of a material differing
from both the first and second materials forming an identifiable
implant device having three or more materials, similar to the
implant device shown in FIG. 3. This material modulation further
increases the density of data recorded in the implant structure
170.
[0056] The implantable structure 170 of the preferred embodiment of
FIG. 6 features a readable portion 178 shown in FIG. 6 to be
disposed on a main portion 180 of an implant device 182. Although
not shown in FIG. 6, the readable portion 178 may be coupled to the
main portion 180 by such means as fasteners or adhesives or through
interference fit. Alternatively, the readable portion 178 of the
implant device 182 may be integral with the main portion 180 of the
implant device 182. The second material having a different density
than the implantable structure 170 shown in FIG. 6 may be a
substance of any material phase including a solid, liquid, or a
gas. The array of internal volumes of FIG. 6 forming embedded
markers 176 may also be voids in the material of the readable
portion 178 of the implantable structure 170. The implantable
structure 170 may be composed of any material such as a metal,
ceramic, or polymer.
[0057] As with the embodiment shown in FIG. 5, each plane 174 in
the three-dimensional array 186 of the preferred embodiment shown
in FIG. 6 features a unique seven-by-seven two-dimensional array
184 of embedded markers 176. The implantable structure 170 of FIG.
6 features the seven unique two-dimensional arrays 184 along the
planes 174 such that the seven-by-seven-by-seven three-dimensional
array 186 is formed. Data is extracted from the three-dimensional
array 186 shown in FIG. 6 through volume imaging used with an
extraction algorithm and advanced error correction coding in three
dimensions. Due to the large amount of data within the internal
array 186 of the implantable structure 170 shown in FIG. 6,
external databases would not be required to access detailed implant
manufacturing information, patient records, surgery data, or other
related medical records. Through image analysis, medical staff
would have immediate access to medical records encoded entirely
within the implant device 182.
[0058] Reference is now made to FIG. 7, which shows an implantable
structure 200 of a preferred embodiment of the present invention.
The implantable structure 200 of the preferred embodiment is a
metal mesh structure fabricated using additive manufacturing (also
known in the art as 3D printing). The Materials Science &
Engineering article titled "Characterization of Ti-6Al-4V Open
Cellular Foams Fabricated by Additive Manufacturing Using Electron
Beam Melting" by Murr, et al. discusses such additive manufacturing
methods to produce such exemplary structures as are displayed in
the article, and is incorporated herein by reference. Through an AM
manufacturing process, a unique internal structure is formed while
maintaining the structural requirements of the implant device 200.
A readable portion 202 includes an internal structure 204 inside
the readable portion 202. The internal structure 204 includes
linking structures 206 that interconnect to form the internal
structure 204. Individual linking structures 206 in the preferred
embodiment shown in FIG. 7 each have a predetermined size and
orientation in reference to a unique registration structure that
would be included in every implant and easily identifiable. As
shown in FIG. 8, the size and orientation of a particular linking
structure 206 of the preferred embodiment of the present invention
is predetermined to represent binary data. As with the embodiments
of the present invention shown in FIGS. 1-6, the data is read to
gather valuable information relating to the implant, patient,
surgical operation, etc. The data contained in the readable portion
202 of the implantable structure 200 can be accurately read through
non-invasive means such as x-ray, fluoroscopy, computed tomography,
electromagnetic radiation, ultrasound, and magnetic resonance
imaging. FIGS. 7A and 8A show, in detail, the readable portion 202,
internal structure 204, and linking structure 206 of the
implantable structure 200 according to one embodiment of the
present invention.
[0059] One or more of the embodiments of the present invention are
structurally encoded devices, which refers to the 3D encoding of
digital information in a structure as variations in geometric or
physical features--widths, densities, color, feature angles, etc.
Bar codes are an example of a 2D encoding of digital information
with modulations of color (dark versus light) with varying widths
of printed bars on a surface. A typical embodiment of the
structurally encoded devices of the present invention may contain
data that is not readily apparent to a viewer of the device
structure. Further, encoding of the typical embodiments of the
present invention is handled by physical means other than those
accomplished through circuitry, electromagnetic or other, within
the implant device itself or through a type of internal storage
means such as magnetic storage means or the like. Such structurally
encoded devices, as disclosed herein and described in relation to
the typical and/or preferred embodiments of the present invention
allow simplified production, maintenance, and/or operation costs
for identification, storage, and/or retrieval of unique implant
data while retaining a substantial amount of information with
reduced probability for error.
[0060] The preferred embodiments of the present invention, as shown
individually in FIGS. 1-9, may be manufactured by one or more of
the AM processes described above. The method of manufacturing an
identifiable implant according to a preferred embodiment of the
present invention comprises providing a main portion of an
identifiable implant device, providing a readable portion of an
identifiable implant device, printing a first material onto a first
readable portion surface to create a first printed layer, and
printing the first material onto the first printed layer to create
a second printed layer. At least one of the printing of the first
material onto the first readable portion surface and the printing
of the first material onto the first printed layer comprises
printing encoded indicia. Further, the encoded indicia may comprise
volumes of a second material having a different density than the
first material found elsewhere in the readable portion of the
identifiable implant device. As an example, the readable portion of
an identifiable implant may be formed by an AM or 3D printing
process such that micro-volumes of a metal material having a
relatively high density are deposited within a polymer substrate
having a relatively low density. The encoded indicia may also
comprise voids in the first material of the identifiable implant
device. Further, any single embodiment of the present invention may
be manufactured using a combination of traditional manufacturing
processes and additive manufacturing processes. For example, a 3D
printed implant device with internal indicia formed by the 3D
printing process may also have a series of notches micromachined
onto an exterior surface of the 3D printed implant device.
[0061] The identifiable implant device of the present invention
enables more accurate reporting, reviewing, and analyzing of
adverse event reports so that problem devices can be identified and
corrected more quickly. Additionally, the identifiable implant
device of the present invention reduces medical error by enabling
health care professionals and others to rapidly and precisely
identify a device and obtain important information concerning the
characteristics of the device. The present invention enhances
analysis of devices on the market by providing a standard and clear
way to document device use in electronic health records, clinical
information systems, claim data sources, and registries. Through
the identifiable implant device of the present invention, a more
robust post-market surveillance system may also be leveraged to
support premarket approval or clearance of new devices and new uses
of currently marketed devices. The present invention further
provides a standardized identifier that will allow manufacturers,
distributors, and healthcare facilities to more effectively manage
medical device recalls. Moreover, the present invention provides a
foundation for a global, secure distribution chain, helping to
address counterfeiting and diversion and prepare for medical
emergencies. The identifiable implant device of the present
invention enables development of a medical device identification
system that is recognized around the world.
[0062] While particular embodiments of the present invention have
been illustrated and described, it would be obvious to those
skilled in the art that various other changes and modifications can
be made without departing from the spirit and scope of the
invention. It is therefore intended to cover in the appended claims
all such changes and modifications that are within the scope of
this invention.
* * * * *
References