U.S. patent application number 15/179192 was filed with the patent office on 2016-09-29 for methods of ordering and manufacturing orthopedic components.
The applicant listed for this patent is Zimmer, Inc.. Invention is credited to Kevin S. Cook, James Grimm, Anthony Romano.
Application Number | 20160278927 15/179192 |
Document ID | / |
Family ID | 56136237 |
Filed Date | 2016-09-29 |
United States Patent
Application |
20160278927 |
Kind Code |
A1 |
Cook; Kevin S. ; et
al. |
September 29, 2016 |
METHODS OF ORDERING AND MANUFACTURING ORTHOPEDIC COMPONENTS
Abstract
Methods of ordering and manufacturing orthopedic components
eliminate the need to stockpile and inventory large volumes of
implants and instruments. In one exemplary embodiment, the surgeon
begins by acquiring anatomical data from a patient. The anatomical
data may then be loaded into a data comparison program. The data
comparison program performs a best-fit analysis by comparing the
patient's anatomical data to a number of predesigned, tested, and
validated virtual implant models that are stored in a database.
Once an implant has been identified by the data comparison program
for the individual patient, the surgeon may place an order
electronically with the manufacturer via the internet. In one
exemplary embodiment, when placing the order, the surgeon will
specify the type of implant, the surgery date, specific patient
information, shipping information, and the preferred surgical
technique that the surgeon anticipates using.
Inventors: |
Cook; Kevin S.; (Warsaw,
IN) ; Grimm; James; (Winona Lake, IN) ;
Romano; Anthony; (Columbia City, IN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Zimmer, Inc. |
Warsaw |
IN |
US |
|
|
Family ID: |
56136237 |
Appl. No.: |
15/179192 |
Filed: |
June 10, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13087081 |
Apr 14, 2011 |
9375303 |
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15179192 |
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61324525 |
Apr 15, 2010 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
G06F 16/90335 20190101;
A61F 2/38 20130101; A61F 2002/30616 20130101; G06Q 10/0832
20130101; A61F 2/0095 20130101; A61F 2/30942 20130101; G06F 19/00
20130101; G16H 10/60 20180101 |
International
Class: |
A61F 2/30 20060101
A61F002/30; A61F 2/00 20060101 A61F002/00; G06F 19/00 20060101
G06F019/00; G06Q 10/08 20060101 G06Q010/08; G06F 17/30 20060101
G06F017/30 |
Claims
1. A method of ordering and manufacturing an implant and related
instruments, comprising the steps of: receiving anatomical data
collected from a patient; comparing the anatomical data to a
database of implant designs; identifying an implant design from the
implant designs in the database based on a result of said step of
comparing the anatomical data to a database of implant designs;
manufacturing an implant based on the identified implant design;
manufacturing at least one instrument for use in implanting the
implant; packaging the implant and the instrument in at least one
container; contemporaneously shipping the implant and the
instrument in the at least one container to a customer, and
receiving the at least one container after the at least one
instrument has been used.
2. The method of claim 1, wherein the instrument involved in said
steps of packaging the implant and instrument and contemporaneously
shipping the implant and instrument is an unused instrument.
3. The method of claim 1, wherein said step of packaging the
implant and the at least one instrument comprises packaging both
the implant and the least one instrument in a single container.
4. The method of claim 1, wherein the at least one instrument is
formed from a recyclable material, the method further comprising,
after said step of receiving the at least one container, the
additional step of: recycling at least one of the container and the
at least one instrument.
5. The method of claim 4, wherein said step of recycling at least
one of the container and the at least one instrument follows said
step of receiving the container.
6. The method of claim 1, wherein said step of receiving the
container comprises an implant manufacturer receiving the
container.
7. The method of claim 1, further comprising the step of
sterilizing the container.
8. The method of claim 7, wherein said step of sterilizing the
container precedes said step of shipping the container to a
customer.
9. The method of claim 7, wherein said step of sterilizing the
container follows said step of shipping the container to a
customer.
10. The method of claim 1, further comprising the step of disposing
of at least part of the container and at least one of the at least
one instrument.
11. The method of claim 1, wherein said step of manufacturing an
implant follows said step of receiving anatomical data.
12. The method of claim 1, wherein said step of manufacturing an
implant comprises manufacturing a custom implant based on the
received anatomical data.
13. The method of claim 12, wherein said step of manufacturing a
custom implant comprises: providing a maximum-material implant
having material thicknesses greater than a plurality of finished
implants; receiving an identity of a chosen finished implant, the
chosen finished implant selected from among the plurality of
finished implants; and removing material from the maximum-material
implant to match the chosen finished implant.
14. The method of claim 1, wherein the implant designs of the
database comprise a plurality of validated implant designs, said
step of manufacturing an implant comprising the step of
manufacturing an implant based on one of the validated implant
designs.
15. The method of claim 1, wherein the step of identifying an
implant design comprises the step of templating.
16. A surgical implant management system, comprising: data
collection means for collecting anatomical data from a patient; an
implant database including a plurality of implant designs; data
comparison means for comparing said anatomical data to said
plurality of implant designs; identifying means for cooperating
with said data comparison means to identify at least one matching
implant, said matching implant closely matching said anatomical
data; ordering means for communicating identifying information
about said matching implant to an implant manufacturer; at least
one implant instrument for use in implanting said matching implant;
packaging means for contemporaneous delivery of said matching
implant and said implant instrument from the implant manufacturer
to a customer; and instrument return means for returning said
implant instrument to said implant manufacturer after use.
17. The system of claim 16, further comprising display means for
displaying results of said comparison of said anatomical data to
said plurality of implant designs.
18. The system of claim 16, wherein said ordering means comprises a
network.
19. The system of claim 18, wherein said network comprises
communication means for communicating between modules in a cloud
computing infrastructure.
20. The system of claim 16, wherein said data comparison means
comprises one of a templating system and a data comparison program.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit under 35 U.S.C.
.sctn.119(e) of U.S. Provisional Patent Application Ser. No.
61/324,525, filed Apr. 15, 2010 and entitled METHODS OF ORDERING
AND MANUFACTURING ORTHOPEDIC COMPONENTS, the entire disclosure of
which is hereby expressly incorporated herein by reference.
BACKGROUND
[0002] 1. Technical Field
[0003] The present disclosure relates to methods of ordering and
manufacturing orthopedic components.
[0004] 2. Description of the Related Art
[0005] Orthopedic components are generally manufactured in various
sizes and in mass quantities which are then provided to
distributors. The distributors fulfill individual sales orders that
may be received from a customer, such as a hospital, surgeon, or
sales person. While this distribution process is effective, it
results in large inventory costs for both the manufacturer and the
distributor.
[0006] For example, in some cases a particular prosthesis design
may be offered in six or seven different sizes to accommodate
natural variations inherent in anatomical structures. Each of these
implant sizes may in turn be offered in two or three style
variations. In addition to the resulting large quantity of
available prostheses conforming to one particular design, multiple
additional implant designs may also be offered in a similar array
of sizes and styles.
[0007] Thus, in order for the manufacturer and/or distributor to
fulfill orders for any implant design, size and style, large
quantities of various orthopedic implants must be maintained in
inventory. The manufacturer must maintain large quantities of
various implant sizes and related surgical instruments to provide
to distributors, and distributors must also stock significant
quantities of implants and instruments to readily fulfill orders
from the end user.
[0008] Additionally, as a result of having a large volume of
inventory, when an implant or instrument becomes obsolete, this
inventory must be disposed of and results in a total economic loss
to the manufacturer and the distributor. Additionally, due to the
large volume of inventories that must be manufactured and
inventoried in order to fulfill customer orders, product launches
may be delayed while an inventory of the product, such as an
implant or instrument, is stockpiled.
[0009] While known manufacturing and distribution methods are
effective, what is needed is an improvement over the foregoing.
SUMMARY
[0010] The present disclosure provides methods of ordering and
manufacturing orthopedic components that eliminate the need to
stockpile and inventory large volumes of implants and instruments.
In one exemplary embodiment, the surgeon begins by acquiring
anatomical data from a patient. The anatomical data may then be
loaded into a data comparison program. The data comparison program
performs a best-fit analysis by comparing the patient's anatomical
data to a number of predesigned, tested, and validated virtual
implant models that are stored in a database. Once an implant has
been identified by the data comparison program for the individual
patient, the surgeon may place an order electronically with the
manufacturer via the internet. In one exemplary embodiment, when
placing the order, the surgeon will specify the type of implant,
the surgery date, specific patient information, shipping
information, and the preferred surgical technique that the surgeon
anticipates using.
[0011] Once the order is placed by surgeon, the order is received
by the implant manufacturer and a manufacturing work order is
generated. The manufacturer then generates the components that have
been ordered using known manufacturing techniques. In one exemplary
embodiment, the order may include both the implant and the
corresponding instruments that are used during surgery to
facilitate implantation of the implant. In one exemplary
embodiment, the instruments that are to be used during the surgery
are manufactured from a recyclable material, such as ultra high
molecular weight polyethylene ("UHMWPE"). Once manufactured, the
implant and instruments may then be packaged in a single kit that
is sterilized and shipped directly to the requesting customer.
[0012] Once the implant and instrument kit is received by the
customer, the kit is transported to the operating room where the
patient has been prepped and the joint opened using standard
techniques. Then, by using the instruments contained within the
single kit, the surgeon performs the required surgery and implants
the implant. Once the surgery is completed, the used instruments
may be returned to the container and the lid of the container
resealed thereon. The sealed container and its contents may then be
returned to a central receiving location, such as the manufacturer.
The entire container may then be destroyed and/or recycled,
eliminating the need to sterilize and otherwise track the
instruments within the hospital or operating room.
[0013] Advantageously, the present disclosure allows for an
individual patient to be provided with the best fitting prosthesis
that is currently available for their individual anatomy.
Additionally, by utilizing just-in-time manufacturing, i.e.,
manufacturing a component only when their order for the component
is received, the cost of inventorying components for both the
manufacturer and the distributor are eliminated. Further, by
packaging all of the components in a single container as a single
kit, a surgeon is ensured that all of the components necessary to
complete the procedure are present in the operating room at the
time the operation is performed. Additionally, since the
instruments may be returned in the same container to the central
receiving location, no cleaning or sterilization of the instruments
by the hospital is required, operating room cleanup time is
reduced, and the need to track the location of the instruments is
eliminated.
[0014] In one form thereof, the present disclosure provides a
method of ordering and manufacturing an implant and related
instruments, comprising the steps of: receiving anatomical data
collected from a patient; comparing the anatomical data to a
database of implant designs; identifying an implant design from the
implant designs in the database based on a result of the step of
comparing the anatomical data to a database of implant designs;
manufacturing an implant based on the identified implant design;
manufacturing at least one instrument for use in implanting the
implant; packaging the implant and the instrument in at least one
container; contemporaneously shipping the implant and the
instrument in the at least one container to a customer; and
receiving the at least one container after the at least one
instrument has been used.
[0015] In another form thereof, the present disclosure provides a
surgical implant management system, comprising: data collection
means for collecting anatomical data from a patient; an implant
database including a plurality of implant designs; data comparison
means for comparing the anatomical data to the plurality of implant
designs; identifying means for cooperating with the data comparison
means to identify at least one matching implant, the matching
implant closely matching the anatomical data; ordering means for
communicating identifying information about the matching implant to
an implant manufacturer, at least one implant instrument for use in
implanting the matching implant; packaging means for
contemporaneous delivery of the matching implant and the implant
instrument from the implant manufacturer to a customer, and
instrument return means for returning the implant instrument to the
implant manufacturer after use.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] The above-mentioned and other features and advantages of
this disclosure, and the manner of attaining them, will become more
apparent and the disclosure itself will be better understood by
reference to the following description of an embodiment of the
disclosure taken in conjunction with the accompanying drawings,
wherein:
[0017] FIGS. 1A and 1B provide a flow chart of the steps of an
exemplary embodiment of the present disclosure;
[0018] FIG. 2 is a perspective view of a surgical kit made in
accordance with the present disclosure; and
[0019] FIG. 3 is a flow chart illustrating an implant planning tool
in accordance with the present disclosure.
[0020] Corresponding reference characters indicate corresponding
parts throughout the several views. The exemplifications set out
herein illustrate exemplary embodiments of the invention, and such
exemplifications are not to be construed as limiting the scope of
the disclosure in any manner.
DETAILED DESCRIPTION
[0021] For the purposes of promoting an understanding of the
principles of the disclosure, reference will now be made to the
embodiments illustrated in the drawings, which are described below.
The embodiments disclosed below are not intended to be exhaustive
or limit the disclosure to the precise form disclosed in the
following detailed description. Rather, the embodiments are chosen
and described so that others skilled in the art may utilize their
teachings. It will be understood that no limitation of the scope of
the disclosure is thereby intended. The disclosure includes any
alterations and further modifications in the illustrated devices
and described methods and further applications of the principles of
the disclosure which would normally occur to one skilled in the art
to which the disclosure relates.
[0022] The detailed descriptions which follow are presented in part
in terms of algorithms and symbolic representations of operations
on data bits within a computer memory representing alphanumeric
characters or other information. These descriptions and
representations are the means used by those skilled in data
processing arts to most effectively convey the substance of their
work to others skilled in the art.
[0023] An algorithm is here, and generally, conceived to be a
self-consistent sequence of steps leading to a desired result.
These steps are those requiring physical manipulations of physical
quantities. Usually, though not necessarily, these quantities take
the form of electrical or magnetic signals capable of being stored,
transferred, combined, compared, and otherwise manipulated. It
proves convenient at times, principally for reasons of common
usage, to refer to these signals as bits, values, symbols,
characters, display data, terms, numbers, or the like. It should be
borne in mind, however, that all of these and similar terms are to
be associated with the appropriate physical quantities and are
merely used here as convenient labels applied to these
quantities.
[0024] Some algorithms may use data structures for both inputting
information and producing the desired result. Data structures
greatly facilitate data management by data processing systems, and
are not accessible except through sophisticated software systems.
Data structures are not the information content of a memory; rather
they represent specific electronic structural elements which impart
a physical organization on the information stored in memory. More
than mere abstraction, the data structures are specific electrical
or magnetic structural elements in memory which simultaneously
represent complex data accurately and provide increased efficiency
in computer operation.
[0025] Further, the manipulations performed are often referred to
in terms, such as comparing or adding, commonly associated with
mental operations performed by a human operator. No such capability
of a human operator is necessary, or desirable in most cases, in
some of the operations described herein which form part of the
present disclosure; rather, the operations are machine operations.
Useful machines for performing these operations of the present
disclosure include general purpose digital computers or other
similar devices. In all cases the distinction between the method
operations in operating a computer and the method of computation
itself should be recognized. The present disclosure relates to a
method and apparatus for operating a computer in processing
electrical or other (e.g., mechanical, chemical) physical signals
to generate other desired physical signals.
[0026] The present disclosure also relates to an apparatus for
performing these operations. This apparatus may be specifically
constructed for the required purposes or it may comprise a general
purpose computer as selectively activated or reconfigured by a
computer program stored in the computer. The algorithms presented
herein are not inherently related to any particular computer or
other apparatus. In particular, various general purpose machines
may be used with programs written in accordance with the teachings
herein, or it may prove more convenient to construct more
specialized apparatus to perform the required method steps. The
required structure for a variety of these machines will be apparent
from the description below.
[0027] A general purpose computer suitable for use with the present
disclosure, in addition to containing the specialized instructions
for performing the operations described in detail below, may also
include operating system software. An exemplary operating system
software is a WINDOWS operating system available from Microsoft
Corporation of Redmond, Wash. Users of the computer activate
computer programs or network resources to create "processes" which
include both the general operation of the computer program along
with specific operations.
[0028] The present disclosure deals with "object-oriented"
software, and particularly with an "object-oriented" operating
system. The "object-oriented" software is organized into "objects,"
each comprising a block of computer instructions describing various
procedures ("methods") to be performed in response to "messages"
sent to the object or "events" which occur with the object. Such
operations include, for example, the manipulation of variables, the
activation of an object by an external event, and the transmission
of one or more messages to other objects.
[0029] Both programs and databases may be objects. In the case of
databases, the data portion of the object may be significantly
larger than the methods portion. The actual physical implementation
of a database on a general purpose computer may take several forms,
from complete individual records storing the substantive
information with several key indexes for locating a particular
record, to a plurality of tables interrelated by relational
operations, to a matrix of cross-linked data records, to various
combinations and hybrids of these general types. In particular
physical devices, a database may be structured and arranged to
accommodate the restrictions of the physical device--but when
transferred to a general purpose computer be able to be stored in a
variety of formats. Thus, while certain types of information may be
described as being stored in a "database" from a conceptual
standpoint, generally such information may be electronically stored
in a variety of structures with a variety of encoding
techniques.
[0030] Databases may contain many types of information, and may
store the information in a variety of encoding techniques. When a
database stores information that relates to a particular person,
product, location, or other thing, the database typically uses a
unique identifier that binds the "concept" of the person, product,
location, or other thing with a storable piece or set of data. When
the unique identifier is used to reference the data record, the
unique identifier is termed a "key" and data records associated
with the "concept" are said to be "keyed" by the unique identifier.
The association between a key and its data may be implemented in a
variety of ways, for example by having the key be a field in a
corresponding data record, by having a key value in a search tree
with an associated pointer to one or more data records
corresponding to the key, or by encoding the corresponding
information with a value that, upon decoding, produces the unique
identifier and the corresponding data, etc. By these various
methods, instances of data may be associated with, or "bound" with
or to, the "concept" by using the key. In the context of the
present disclosure (and as described in greater detail below), a
virtual model of a particular patient's anatomy (i.e., an articular
surface of a bone) may be keyed to a data record for a particular
"best fit" implant component.
[0031] A general purpose computer for use with the present
disclosure may include communications software which allows the
computer to communicate with one or more computer networks, such as
a local area network, a wide area network, a public switched
network, any type of wired network, any type of wireless network,
and combinations thereof. An exemplary public switched network is
the Internet. Exemplary communications software includes browser
software, and other types of software which permit the computer to
communicate with other devices across a network. In one embodiment,
the computer also communicates with one or more additional general
purpose computers over a network, such as remote computers forming
part of a hospital network or surgery center network (as described
in detail below).
[0032] The terms "network," "local area network," "LAN," "wide area
network," or "WAN" mean two or more computers which are connected
in such a manner that messages may be transmitted between the
computers. In such computer networks, typically one or more
computers operate as a "server," a computer with large storage
devices such as hard disk drives and communication hardware to
operate peripheral devices such as printers or modems. Other
computers, termed "workstations," provide a user interface so that
users of computer networks can access the network resources, such
as shared data files, common peripheral devices, and
inter-workstation communication.
[0033] The computers have at least one processor for executing
machine instructions, and memory for storing instructions and other
information. Many combinations of processing circuitry and
information storing equipment are known by those of ordinary skill
in these arts. A processor may be a microprocessor, a digital
signal processor ("DSP"), a central processing unit ("CPU"), or
other circuit or equivalent capable of interpreting instructions or
performing logical actions on information. Memory includes both
volatile and non-volatile memory, including temporary and cache, in
electronic, magnetic, optical, printed, or other format used to
store information. Memory may be located either locally with the
computer (removably or non-removably), or may be accessible across
the network. By way of example, a computer-readable medium suitable
as memory may include, but is not limited to, RAM, ROM, EEPROM,
flash memory or other memory technology, CD-ROM, Digital Versatile
Disk (DVD) or other optical disk storage, magnetic cassettes,
magnetic tape, magnetic disk storage or other magnetic storage
devices, or any other medium which may be used to store the desired
information and which may be accessed by the computer.
[0034] While a general purpose computer may be provided for
performing the computational and memory storage tasks described
herein, it is also contemplated that such tasks may be spread out
across various computing and memory-storage resources connected via
a network. Such a network based distribution of computing and
memory storage resources may be referred to as "cloud" computing.
For example, the memory which stores the data comparison program
may be located in a remote memory storage unit, where the data
comparison program may be pooled with other stored programs (which
may or may not be related to the data comparison program).
Similarly, the computer processor responsible for executing machine
instructions (i.e., for executing the data comparison program) may
be located in location remote from the memory storage unit and
connected thereto via the network.
[0035] The present disclosure provides a method for ordering and
manufacturing orthopedic implants and/or instruments. As described
below, a system in accordance with the present disclosure may
include a data comparison program. The data comparison program is
run by a computer and operates to compare an individual patient's
anatomical data against a plurality of individual implant models,
e.g., an implant database, to identify a particular implant that
best matches an individual patient's anatomy. In one exemplary
embodiment, the data comparison program includes a database having
information related to different implant types and specific sizes
and designs of implants within each implant type. For example, knee
implants may be identified within the database as having both
femoral components and tibial components. Additional information
about each individual component is also contained within the
database. For example, for a femoral component adapted to replace
the articular surfaces at the distal end of a femur, the width of
the medial and lateral condyles, the height and width of the
patello-femoral flange, and the overall implant height and width of
the femoral component may be entered into and stored in the
database. Then, if a surgeon requests a femoral component for an
individual patient, the surgeon will enter the available, patient
specific information. Then, the data comparison program will
compare the patient specific information to each of the femoral
components within the database to determine which of the femoral
components provides the best overall fit for the individual
patient, as described in detail below.
[0036] In one exemplary embodiment, the database may be stored in a
first location, such as in the memory of a server managed by an
implant manufacturer. The patient information may be transmitted or
otherwise provided to the data comparison program via the internet
if the data input location is remote, such as where the patient
information is entered at a hospital or doctor's office.
Alternatively, the patient information may be transmitted by a
direct network connection, such as from a terminal connected
directly to the implant manufacturer's server. In another exemplary
embodiment, the implant database may be stored in the surgeon's
individual computer, which in turn runs the data comparison program
using patient-specific data entered by the surgeon.
[0037] Once the data comparison program has identified the most
appropriate implant based on a patient's individual anatomy, an
order may be placed to request that the implant manufacturer
initiate the manufacture of the implant. In one exemplary
embodiment, the order is placed by the surgeon via the internet. In
another exemplary embodiment, the order is placed over a network.
Once the order is received, the manufacturer may create the implant
and package the implant with related unused instruments for
shipment to the consumer, such as in the manner described in detail
below. After the implantation of the implant, the used instruments
may be returned to the manufacturer for disposal.
[0038] Turning now to FIGS. 1A and 1B, a flow chart illustrating
the steps of an exemplary embodiment of the present disclosure is
shown. Specifically, referring to Step 10, a surgeon begins by
acquiring anatomical data from an individual patient that may be
provided to the data comparison program. In one exemplary
embodiment, the anatomical data is collected by collecting a series
of two-dimensional X-ray images, then combining the images to form
a three-dimensional model of the patient's anatomy.
[0039] In another exemplary embodiment, accelerometers are used to
track the motion of respective articular surfaces in the patient's
joint as the joint is articulated through its range of motion. The
tracked motion is collected to create a data set. The data set is
manipulated using a software program to provide an overview or map
of an individual patient's knee joint motion. An exemplary method
and apparatus for characterizing a joint by tracking articulation
is described in U.S. patent application Ser. No. 12/854,610, filed
Aug. 11, 2010 and entitled VIRTUAL IMPLANT PLACEMENT IN THE OR
(Attorney Docket ZIM0769-01/ZI-00548), which commonly assigned with
the present application, the entire disclosure of which is hereby
expressly incorporated by reference herein.
[0040] In other exemplary embodiments, magnetic resonance imaging
(MRI), computed tomography (CT), positron emission tomography
(PET), X-ray, ultrasound, or any other imaging modality may be used
to identify and characterize the patient's individual anatomy. Once
the patient's individual anatomy has been determined, a data file
containing the patient's individual anatomical information may be
created and stored. The data file containing such anatomical
information may be generated using any of the methods disclosed in
the following documents, all of which are commonly assigned with
the present application, the entire disclosures of which are hereby
expressly incorporated by reference herein: Patent Cooperation
Treaty Application Publication No. WO 2010/099360, filed Feb. 25,
2010 and entitled CUSTOMIZED ORTHOPAEDIC IMPLANTS AND RELATED
METHODS; Patent Cooperation Treaty Application Publication No. WO
2009/025783, filed Aug. 18, 2008 and entitled IMPLANT DESIGN
ANALYSIS SUITE; Patent Cooperation Treaty Application Publication
No. WO 2010/099359, filed Feb. 25, 2010 and entitled CUSTOMIZED
ORTHOPAEDIC IMPLANTS AND RELATED METHODS; U.S. patent application
Ser. No. 11/685,906, filed Mar. 14, 2007 and entitled METHODS OF
PREDETERMINING THE CONTOUR OF A RESECTED BONE SURFACE AND ASSESSING
THE FIT OF A PROSTHESIS ON THE BONE (Attorney Docket ZIM0317-01);
U.S. patent application Ser. No. 12/410,884, filed Mar. 25, 2009
and entitled METHOD AND SYSTEM FOR PLANNING/GUIDING ALTERATIONS TO
A BONE (Attorney Docket ZIM0750; U.S. patent application Ser. No.
12/410,854, filed Mar. 25, 2009 and entitled TRACKING SYSTEM AND
METHOD; and U.S. Provisional Patent Application Ser. No.
61/342,873, filed Apr. 21, 2010 and entitled SYSTEM AND METHOD FOR
ASSESSING IMPLANT FIT TO AN ANATOMICAL FEATURE (Attorney Docket
ZIM0818).
[0041] Referring now to Step 20, once a patient's anatomical data
has been acquired and/or a data file created, the data may be
uploaded to the computer running the data comparison program. In
one exemplary embodiment, data files containing each of the
two-dimensional X-ray images are uploaded to the computer running
the data comparison program. In this embodiment, the data
comparison program may also include a data manipulation program
that accesses the uploaded data files and combines the
two-dimensional X-rays into a three-dimensional model. The data
comparison program can then extract specific measurements of the
individual patient's anatomy for later comparison to implant
information contained in the database.
[0042] Similarly, in one exemplary embodiment, the data comparison
program may include an additional module that allows for uploaded
accelerometer data to be mapped to show joint motion. Once the
patient's individual anatomical data is collected according to the
methods described herein, the anatomical data is uploaded to the
computer running the data comparison program. Other data provided
to the data comparison program may include, for example, the type
of implant desired, the surgery date and any relevant patient
information, shipping information, and a preferred surgical
technique that the surgeon may anticipate using for the
implantation of the implant.
[0043] The data comparison program accesses the uploaded data and
performs a comparison of the patient's anatomical data to a
database containing information related to validated virtual
implant models, as described in detail above, at Step 30. In an
exemplary embodiment, the validated implant designs of the implant
database are designs that have undergone standardized analyses,
such as risk assessment analysis, design verification, design
testing and validation, regulatory submissions, and other analyses.
These standardized analyses, or design controls, have the potential
to constrain or alter features and geometrical configurations
incorporated into a design. In contrast, the features and
geometrical configurations of a custom implant design are generally
specified by an individual surgeon, and are not subject to the
design controls of a validated implant design. For example, a
validated implant may be subject to regulatory approval (such as
from the Food and Drug Administration of the United States), while
a custom implant may be considered a "prescription" device and thus
may not be subject to the same regulatory approval
requirements.
[0044] By comparing specific information about the individual
patient's anatomy to information about specific implant designs
stored in the database, the data comparison program identifies the
implant that best matches the individual's anatomical data at Step
35. This "best-fit" implant is displayed on a monitor for review by
the surgeon, who is provided with an opportunity to review the
system's chosen implant. An exemplary method and apparatus for
comparing the anatomical data to various implant characteristics
and determining a "best-fit" implant is described in U.S. patent
application Ser. No. 11/685,906 entitled METHODS OF PREDETERMINING
THE CONTOUR OF A RESECTED BONE SURFACE AND ASSESSING THE FIT OF A
PROSTHESIS ON THE BONE, which is incorporated by reference
above.
[0045] Alternatively, the surgeon (or another person) may perform
the comparison of step 30 manually by templating. Templating is
accomplished by a person performing a comparison of various aspects
of the collected anatomical data to templates representative of one
or more implants. For example, a certain two-dimensional X-ray
image may be overlaid on a corresponding two-dimensional schematic
representation (i.e., a template) of an implant or implants. The
shape of implant shown on the template is visually compared and
contrasted to the anatomic X-ray. This process is iteratively
repeated with various templates until a satisfactory comparison
between the implant template and the anatomic structures is
achieved. Exemplary methods and apparatuses for templating are
described in U.S. patent application Ser. No. 11/458,257, filed
Jul. 18, 2006 and entitled METHOD FOR SELECTING MODULAR IMPLANT
COMPONENTS (Attorney Docket ZIM0297), and in U.S. patent
application Ser. No. 11/616,369, filed Dec. 27, 2006 and entitled
METHOD FOR SELECTING MODULAR IMPLANT COMPONENTS (Attorney Docket
ZIM0297-01), both of which are commonly assigned with the present
application, the entire disclosures of which are hereby expressly
incorporated herein by reference.
[0046] The surgeon may make changes as desired, including selecting
a different implant or modifying the data previously entered and/or
calculated by the data comparison program. This may be required,
for example, in a situation where the collected anatomical data
includes deformity or tissue damage, and the data comparison
algorithm may not sufficiently detect, characterize, and/or account
for such anomaly. For example, where a deformity is diagnosed (such
as by pre-operative imaging, as discussed above), the surgeon may
make an intra-operative decision to correct for such deformity
using augmentation or other suitable surgical tools and methods. To
the extent necessary, the system of the present disclosure allows
the surgeon to manually select an appropriate implant to ensure
compatibility with his or her chosen method of deformity
correction.
[0047] In one exemplary embodiment, the data comparison program may
display multiple implants for review by the surgeon. For example,
the surgeon may reject the "best-fit" implant identified at step
35. The surgeon may then be presented with a "second-best-fit"
implant identified by the data comparison program. To identify the
second-best-fit implant, the data comparison program again
identifies the implant that best matches the individual's
anatomical data from the database of implants in the same manner as
described above with respect to steps 30 and 35, except that the
previously-identified best-fit implant is excluded from the
database. The surgeon may then review and accept or reject the
second-best-fit implant. If the surgeon rejects the second-best-fit
implant, steps 30 and 35 are again performed with the best-fit and
second-best-fit implants excluded from the database, resulting in
identification of a third-best-fit implant. This process may
continue iteratively until the surgeon identifies an acceptable
implant.
[0048] Once the surgeon selects a satisfactory implant, the surgeon
may, at Step 40, confirm the selection and cause an order for the
implant to be automatically placed with the manufacturer over the
internet or another computer network.
[0049] At Step 50, after the order is confirmed by the surgeon, the
communications software may direct the order information to a
customer service department of an implant manufacturer, and/or may
generate a manufacturing work order that is provided directly to
the manufacturing department of the manufacturer.
[0050] Steps 20 through 50 may be accomplished using any of the
methods and apparatuses disclosed in the foregoing and in the
following patent applications, all of which are incorporated by
reference above: Patent Cooperation Treaty Application Publication
Nos. WO 2010/099360, WO 2009/025783, and WO 2010/099359; U.S.
patent application Ser. Nos. 11/685,906, 12/410,884, and
12/410,854; and U.S. Provisional Patent Application Ser. No.
61/342,873.
[0051] By identifying the implant that most closely approximates
the patient's individual anatomy from the implant database, the
patient and surgeon are assured that the implant will have the best
possible fit of any implant within the database. Additionally, the
implant selected by the data comparison program is not limited by
inventory constraints, because the implant can be manufactured
specially for the placed order or sourced directly from existing
inventory, if available. Thus, a system made in accordance with the
present disclosure eliminates the need to inventory and manufacture
a large number of individual implants.
[0052] Further, by providing, in one embodiment, internet based
access to the data comparison program, the ability to identify the
best implant for an individual patient is not geographically
limited. In some instances, for example, specific implants are made
available for particular population subsets within a geographical
area. An example may include specialized implants adapted for
compatibility with the anatomical features of Asian patients, in
which these specialized implants are made available primarily in
Asian countries. However, implants adapted for particular
population subsets may not be readily available to surgeons in
markets where the patient population lacks a significant
presence.
[0053] Using a network-based ordering system in accordance with the
present disclosure, a full range of population-specific implants
may be included in the implant database. Thus, for example, a
surgeon treating an Asian patient in the United States can use the
data comparison program, discussed above with respect to steps 30
and 35, to compare the patient's unique anatomical features to a
wider range of implants than would normally be available. Because
the implant can be custom-manufactured to satisfy the surgeon's
specific order, the inventory available in the surgeon's
geographical area will not limit the surgeon's implant choices.
Alternatively, the specific chosen implant may be sourced from
existing inventories, including overseas inventories, and shipped
to the surgeon.
[0054] Referring to Step 60, once an order has been received by the
manufacturer, the requested implant and related instruments are
manufactured. In one exemplary embodiment, when a work order is
generated, implant models, computer and numerical programs,
inspection programs, and package setup information may also be
generated by an additional module of the data comparison program.
This information may then be used by the manufacturing department
to quickly and efficiently generate the individual implant.
Alternatively, the individual implant may be generated using known
manufacturing techniques without the generation of individual
manufacturing plans by the data comparison program.
[0055] In an exemplary embodiment, the manufacturer may carry a
stock of"maximum material" implants which have the greatest
material thicknesses of any of a range of implants for a given
implant size. The surgeon begins by choosing the size of the
implant based on a planned series of cuts in the distal femur
(sometimes referred to as "box cuts"), which in turn are a function
of the size and shape of an individual patient's anatomy. A
plurality of implants are then displayed which match the chosen
implant size, such that each displayed implant has a configuration
of bone-contacting surfaces that will fit the proposed series of
cuts in the distal femur. After the surgeon chooses one of the
displayed implants and places an order for the same, the
manufacturer can remove material from a "maximum material" implant,
apply any finishing processes as required or desired, and ship the
prepared implant to the surgeon. Because this manufacturing process
only involves material removal (such as by milling, grinding or
other machining processes) and finishing steps, the newly prepared
implant can be quickly produced and delivered.
[0056] In one embodiment, a central clearing house may be utilized
to manage a pre-existing inventory of pre-manufactured implants.
Such a central clearing house may include, for example, commonly
used implant sizes and styles so that orders for such implants can
be quickly satisfied from existing stock. Replacements for implants
taken from the existing inventory may be manufactured as
inventories are depleted.
[0057] In an exemplary embodiment, the individual implant may be
manufactured immediately after receipt of the order and be ready
for shipment, thereby effectuating "just-in-time" delivery of the
implant. Such delivery not only reduces inventory and implant
management complications, but ultimately provides the patient with
a patient-specific implant which has been tailored to provide the
best fit possible. As noted above, a wide range of standard,
validated implant designs are included in the implant database.
However, it is contemplated that a custom implant design may be
created and manufactured to satisfy an order in some instances.
[0058] In one exemplary embodiment, instruments may be manufactured
for use with the individual implant from a recyclable or disposable
material, such as UHMWPE. Advantageously, by forming the
instruments from a polymer or other recyclable or disposable
material, the instruments need not be sterilized for subsequent
reuse or otherwise retained by the hospital, as discussed in detail
below.
[0059] Once the manufacture of the implant and instruments is
complete, the implant and the new, unused instruments are packaged
together into a single kit or container 200 (FIG. 2) at Step 70
(FIG. 1A). Container 200 prepared at Step 70 may contain the
selected individual implant 210, packaged together with all of the
instruments associated with an individual patient's surgery.
Instruments included in the kit may include, for example, those
instruments necessary to prepare the bone for implantation of the
implant. The instruments 220 may include alignment guides, cut
guides, drill guides, pin guides, patient-specific guides, and any
other preparatory-type instruments or guidance-type instruments
necessary to effectuate implantation. In an exemplary embodiment,
the instruments 220 are custom-made for the particular patient
based on the previously-collected anatomical data and
previously-completed data comparison. The instruments 220 and
implant 210 may be configured for a particular surgical
application, such as a total knee application including femoral
component 230, tibial baseplate 240 and tibial bearing component
250, together with drill guides and/or cut guides 260, 270, 280,
282. Other tools including moving parts, such as pin handling tool
284, may be included in the surgical kit, in either
disposable/recyclable form or reusable/sterilizable form. Moreover,
it is contemplated that any other application may be made into a
kit in accordance with the present disclosure, including at least
one of a unicompartmental knee application, a hip application, an
extremity application such as an elbow, shoulder, or ankle, a spine
application, a dental application, a sports medicine application,
or any other surgical application required.
[0060] Exemplary methods and apparatuses for packaging medical
instruments are disclosed in U.S. Pat. No. 7,320,404, filed Aug.
10, 2005 and entitled MEDICAL PACKAGING and U.S. patent application
Ser. No. 12/331,016, filed Dec. 9, 2008 and entitled METHOD AND
APPARATUS FOR PACKAGING MEDICAL DEVICES, both of which are commonly
assigned with the present application, the entire disclosures of
which are hereby expressly incorporated by reference herein.
[0061] The container may then be sealed and sterilized at Step 80.
The container and its contents may be sterilized at the
manufacturer or at the end user location, such as a hospital or
clinic. Alternatively, the case may be sterilized at an
intermediate location. In the illustrative embodiment of FIG. 2,
seal 290 may be applied to the upper open rim 300 of container 200
in an airtight fashion, thereby hermetically sealing implant 210
and instruments 220 within container 200. Seal 290 may be made of a
foil or plastic material, for example, and may be adhesively
attached to rim 300. Lid 310 may then be connected to container 200
for later resealing of used contents, as described in greater
detail below.
[0062] The implant kit is shipped directly to the customer at Step
90. As described above, the customer may be an individual surgeon.
However, in other exemplary embodiments, the customer may be a
hospital or other healthcare provider. Once the kit is received by
the customer, the kit may be brought into an operating room where
the patient has been prepped and the joint opened per standard
procedures. As indicated above and illustrated in FIG. 2, contained
within the individual kit are all of the instruments 220 necessary
for implantation of the desired implant 210. The contents of the
kit are accessed by removal of lid 310, and peeling away of seal
290.
[0063] At Step 100, implant 210 is then implanted. As noted above,
the surgeon may specify a preferred surgical technique as part of
the data provided to the implant manufacturer. When such
information has been provided, the kit may include a customized
selection of instruments 220 based upon the surgeon's preselected
surgical technique.
[0064] After the surgery is completed, an individual within the
operating room, such as a scrub nurse, may return the used
instruments 220 to the container 200 and replace lid 310 to seal
the kit in a closed condition at Step 110. The sealed kit may then
be returned to a central receiving location, such as the
manufacturer, at Step 120. Once received by the central receiving
location, the instruments 220 and container 200 may be processed,
such as by recycling the instruments 220 and container 200 so that
the entire kit is recycled at Step 130. Alternatively, container
200 and/or one or more of instruments 220 may be sterilized and
reused. In an exemplary embodiment, the central receiving location
and manufacturing/warehousing location will be the same, such that
surgical kits can be prepared, distributed, received and
sterilized/disposed of efficiently. For worldwide service, multiple
central receiving locations may be provided in certain regions,
i.e., the United States, Europe and Asia, in order to reduce
logistical constraints and facilitate rapid processing of implant
orders and returns.
[0065] Advantageously, by utilizing the process of the present
disclosure, the kit and instruments used to perform an individual
patient's surgery may be disposed of in an environmentally friendly
manner. Additionally, the need for a hospital to inventory and
track the individual instruments is eliminated. Providing a single
kit containing all of the instruments and implant also streamlines
surgical preparation procedures, as it eliminates the need for a
surgeon or other operating room personnel to identify and collect
all of the individual instruments from various locations throughout
a facility.
[0066] Utilizing a system and/or method in accordance with the
present disclosure, an individual patient is provided with an
implant that best matches the patient's individual anatomy and
accommodates the preferred surgical techniques of the surgeon.
[0067] Additionally, the manufacturer and distributors are no
longer required to stock a significant amount of inventory, such as
a plurality of individual sizes of each individual implant design
and/or component, which reduces the need for ample storage space
and decreases overall inventory costs.
[0068] Further, implant upgrades or design innovations may be
inexpensively, quickly and easily incorporated into the instruments
and/or implants, as the implants need not be stockpiled in
significant quantities and instrument sets are not reused. Thus,
each individual surgery is provided with the most up-to-date
instruments currently available.
[0069] By allowing the instruments to return to a central receiving
location, the need to sterilize or otherwise clean the instruments
at the location of use is eliminated.
[0070] The systems described herein may utilize an online or
network-based management system to track, communicate, and
otherwise manage the entire process from image acquisition to
instrument return. The online management system 400 may utilize
mobile devices, such as an iPhone or iPad device, to interface with
the system, thereby providing an easy-to-use interface for the
surgeon.
[0071] Turning to FIG. 3, for example, online management system
(OMS) 400 may use a joint reconstruction planning wizard which
guides a surgeon through a step-by-step approach from acquiring the
image, to planning the surgery, to a virtual implantation, to final
ordering and return of the components used for the surgery. OMS 400
begins by displaying an anterior and/or posterior view of the femur
and tibia of the patient at step 402. The display may be created
from pre-operative imaging, as discussed above, and may initially
display the femur and tibia in a fully extended orientation.
[0072] Presented with this display, the surgeon then assesses and
virtually adjusts proposed resections of the femur and tibia at
step 404, in accordance with the surgeon's preference. Based on
these resections, the OMS 400 selects one or more proposed
implants, and these selected implants are superimposed on the
virtually resected femur and tibia. The surgeon may then assess, at
step 406, whether the extension gap--i.e., the space between the
femoral and tibial implant components in full extension--is
satisfactory. If the extension gap is too large or too small, OMS
400 reverts to step 404 and a different resection profile and/or
implant may be selected iteratively until the extension gap is
satisfactory. Once the extension gap is satisfactory, OMS 400
advances to flexion gap assessment as described below.
[0073] At step 408, the femur and tibia are again displayed to the
surgeon, this time showing the anterior and/or posterior view of
the tibia and the distal view of the femur in flexion. The surgeon
then selects one or more desired rotational orientations of the
femur at step 410, i.e., various rotational orientations associated
with flexion of the knee. At step 412, with the virtual knee
"flexed," the flexion gap--i.e., the space between the femoral and
tibial implant components in a state of flexion--is assessed. If
the flexion gap is too large or too small, OMS 400 reverts to step
410 and a different flexion level and/or implant may be selected
iteratively until the flexion gap is satisfactory. The profile of
one or more of the femur resections may also be iteratively
adjusted, such as the cuts on the posterior portion of the femoral
condyles. Once the flexion gap is satisfactory, OMS 400 advances to
implant antero-posterior position assessment as described
below.
[0074] At step 414, the femur and tibia are again displayed to the
surgeon, this time showing a sagittal view of the tibia and femur.
The surgeon then assesses, at step 416, the antero-posterior
position of the previously-chosen implant components. If the
antero-posterior positions of the components relative to one
another and to their respective bones are not satisfactory, the
surgeon adjusts such positioning at step 418 and OMS 400 reverts
back to step 408 to begin reassessment of the flexion gap as
described above. This process is iteratively repeated until the
flexion gap and antero-posterior position of the implants are both
satisfactory.
[0075] OMS 400 then advances to step 420, where tibial rotation and
position are set by the surgeon according to his or her preference.
With all parameters needed for the manufacture of implant 210 as
discussed above, the surgical plan and implants are approved at
step 422 and a surgical kit in accordance with the present
disclosure may be ordered.
[0076] Online management system 400 simplifies processes,
advantageously employs current technology, reduces surgeon input
time, manages inventory, reduces costs for the manufacturer, and
provides the patient with a quicker and more efficient process for
their surgery.
[0077] While this disclosure has been described as having an
exemplary design, the present invention can be further modified
within the spirit and scope of this disclosure. This application is
therefore intended to cover any variations, uses, or adaptations of
the disclosure using its general principles. Further, this
application is intended to cover such departures from the present
disclosure as come within known or customary practice in the art to
which this disclosure pertains and which fall within the limits of
the appended claims.
* * * * *