U.S. patent application number 15/644869 was filed with the patent office on 2017-10-26 for method of managing the inventory of equipment used during a surgical procedure by inductively reading data from the equipment used in the procedure.
The applicant listed for this patent is Stryker Corporation. Invention is credited to Donald W. Malackowski.
Application Number | 20170303984 15/644869 |
Document ID | / |
Family ID | 23204777 |
Filed Date | 2017-10-26 |
United States Patent
Application |
20170303984 |
Kind Code |
A1 |
Malackowski; Donald W. |
October 26, 2017 |
METHOD OF MANAGING THE INVENTORY OF EQUIPMENT USED DURING A
SURGICAL PROCEDURE BY INDUCTIVELY READING DATA FROM THE EQUIPMENT
USED IN THE PROCEDURE
Abstract
A method for managing inventory of components used during a
surgical procedure involving a surgical device and a control unit
coupled to the surgical device Each component includes a circuit
for storing identification data by the surgical device or control
unit when the component is coupled to the surgical device. During a
surgical procedure, the identification data are inductively read
from the components Then, the inventor is managed based on the
received identification data.
Inventors: |
Malackowski; Donald W.;
(Schoolcraft, MI) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Stryker Corporation |
Kalamazoo |
MI |
US |
|
|
Family ID: |
23204777 |
Appl. No.: |
15/644869 |
Filed: |
July 10, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14014807 |
Aug 30, 2013 |
9707026 |
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15644869 |
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12493826 |
Jun 29, 2009 |
8535342 |
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14014807 |
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10214937 |
Aug 8, 2002 |
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12493826 |
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60310957 |
Aug 8, 2001 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2034/102 20160201;
A61B 17/8875 20130101; A61B 34/20 20160201; A61B 2217/005 20130101;
A61B 2017/00482 20130101; A61B 17/1626 20130101; A61B 17/32002
20130101; A61B 2017/00464 20130101; A61B 90/98 20160201; A61B
2034/256 20160201; A61B 2217/007 20130101; A61B 2017/00477
20130101; A61B 17/162 20130101; A61B 2017/00017 20130101; A61B
17/1688 20130101; A61B 90/40 20160201; A61B 2090/0804 20160201;
A61B 2017/00221 20130101 |
International
Class: |
A61B 17/88 20060101
A61B017/88; A61B 34/20 20060101 A61B034/20; A61B 90/98 20060101
A61B090/98; A61B 17/16 20060101 A61B017/16; A61B 17/16 20060101
A61B017/16; A61B 17/32 20060101 A61B017/32 |
Claims
1. A method for managing inventory of components used during a
surgical procedure involving a surgical device and a control unit
coupled to the surgical device, and with each component comprising
a circuit integrated therein for storing and enabling inductive
reading of identification data by the surgical device or control
unit when the component is coupled to the surgical device, and with
at least one of the surgical device and the control unit being
coupled over a network to a database having a processor coupled
thereto, the method comprising the database and processor
performing the steps of: receiving, from the surgical device or
control unit, identification data inductively read from one or more
components used during the surgical procedure; and managing
inventory of the one or more used components based on the received
identification data.
2. A method for managing inventory of components used during a
surgical procedure involving a surgical device and a control unit
coupled to the surgical device and with a storage unit being
configured to store each component, and with each component
comprising a circuit integrated therein for storing and enabling
inductive reading of identification data by the surgical device or
control unit when the component is coupled to the surgical device
and by the storage unit when the component is stored therein, and
with at least one of the surgical device and the control unit, and
the storage unit, being coupled to an inventory database having a
processor coupled thereto, the method comprising the inventory
database and processor performing the steps of: receiving, from the
surgical device or control unit, identification data inductively
read from one or more components used during the surgical
procedure; receiving, from the storage unit, identification data
inductively read from any one or more components used during the
surgical procedure that are stored in the storage unit; analyzing
the received identification data to determine whether one or more
components used during the surgical procedure are missing from the
storage unit; and transmitting an alert to the control unit that
the identified one or more components are missing from the storage
unit.
3. A method for managing billing for use of one or more components
used during a surgical procedure, with each component comprising a
circuit integrated therein for storing and enabling inductive
reading of identification data by a surgical device or control unit
involved in the surgical procedure when the component is coupled to
the surgical device, and with at least one of the surgical device
and the control unit being coupled, over a network, to a billing
processor and with the method comprising the billing processor
performing the steps of: receiving, from the surgical device or
control unit, identification data inductively read from one or more
components used during the surgical procedure; determining, based
on the received identification data, whether any of the used
components qualify as being chargeable for billing purposes; and
generating a bill associated with the used components that qualify
as being as being chargeable for billing purposes.
4. A method for managing inventory of one or more components used
during a surgical procedure, with each component comprising a
circuit integrated therein for storing and enabling inductive
reading of identification data by a surgical device or control unit
involved in the surgical procedure when the component is coupled to
the surgical device, and with at least one of the surgical device
and the control unit being coupled, over a network, to an inventory
control database and processor in communication with a supplier
ship node, with the method comprising the inventory control
database and processor performing the steps of: receiving, from the
surgical device or control unit, identification data inductively
read from one or more components used during the surgical
procedure; monitoring an inventory level of the one or more
components based on the received identification data; and
transmitting, to the supplier ship node, a request for shipment of
additional components based on monitoring the inventory level.
5. A method for electronically documenting use of one or more
components utilized during a surgical procedure, with each
component comprising a circuit integrated therein for storing and
enabling inductive reading of identification data by a surgical
device or control unit involved in the surgical procedure when the
component is coupled to the surgical device, and with at least one
of the surgical device and the control unit being coupled, over a
network, to a patient records database and processor and with the
method comprising the patient records database and processor
performing the steps of: receiving, from the surgical device or
control unit, identification data inductively read from one or more
components used during the surgical procedure; and associating the
identification data with a patient record corresponding to a
patient subject to the surgical procedure during which the one or
more components were used.
Description
RELATIONSHIP TO EARLIER FILED APPLICATION
[0001] This application is a divisional of U.S. patent application
Ser. No. 14/014,807 filed 30 Aug. 2013 now U.S. Pat. No. 9,707,026.
Application Ser. No. 14/014,807 is a divisional of U.S. patent
application Ser. No. 12/493,826, filed 29 Jun. 2009, now U.S. Pat.
No. 8,535,342. Application Ser. No. 12/493,826 is a divisional of
application Ser. No. 10/214,937, filed 8 Aug. 2002 which is now
abandoned. Application Ser. No. 10/214,937 claims priority from the
Applicant's U.S. Patent Application Ser. No. 60/310,957, SURGICAL
TOOL SYSTEM WITH A CUTTING ACCESSORY THAT CONTAINS A MEMORY WITH
DATA THAT DESCRIBES THE OPERATING CHARACTERISTICS OF THE CUTTING
ACCESSORY, filed 8 Aug. 2001. The contents of the priority
applications are incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] The Applicant's Assignee's U.S. Pat. No. 6,017,354, entitled
INTEGRATED SYSTEM FOR POWERED SURGICAL TOOLS, issued Jan. 25, 2000,
and incorporated herein by reference, describes a surgical tool
system with a handpiece that is removably attached to a control
console. Internal to the handpiece is a memory, a NOVRAM. The
NOVRAM contains data that describes the operating characteristics
of the handpiece. For example, if the handpiece includes a motor,
its NOVRAM includes data indicating the maximum speed at which the
motor should run and, for given speeds, the maximum torque the
motor is allowed to develop. Each time a new handpiece is attached
to the control console, the data in the handpiece NOVRAM is read by
a complementary processor in the control console. The control
console, based on the handpiece NOVRAM data, then supplies the
appropriate energizaton signal to the handpiece motor.
[0003] An advantage of the foregoing system is that it allows a
single control console to be used to supply the energizaton signals
that are applied to the handpiece that have different power
consuming units, such as motors. Thus, a single control console can
be used to operate a first handpiece with a motor that rotates at
speeds under 3,000 RPM and requires 350 Watts or more of power, a
second handpiece that has a motor that operates at speeds over
70,000 RPM and that requires approximately 150 Watts of power and a
third handpiece that operates at speeds between 10,000 to 40,000
RPM and that requires only 40 Watts of power.
[0004] In most surgical systems, the handpiece is not the actual
component that is applied to the surgical site in order to
accomplish a surgical task. These components are, what are referred
to as cutting accessories.
[0005] Typically, a single handpiece is used to actuate a number of
different types of cutting accessories. For example, a handpiece
designed to perform some forms of ear, nose and throat surgery is
designed to actuate both burrs and cutters. Burrs are cutting
accessories designed to selectively shape and remove hard tissue,
bone. Cutters are cutting accessories that are employed to
selectively shape and remove soft tissue such as sinus membrane
tissue.
[0006] While a single handpiece is designed to actuate different
types of cutting accessories, the accessories themselves often have
different operating characteristics. For example, some burrs may
have a preferred operating speed of 6,000 RPM and may be designed
to operate at speeds of up to 10,000 RPM. In contrast, some cutters
may have a preferred operating speed of 2,000 RPM and may be
designed to operate at a maximum speed of 5,000 RPM. Moreover, some
cutting accessories are operated in a different manner than other
cutting accessories. For example, a burr is driven, rotated, in a
single direction. A cutter is typically oscillated. In other words,
when a cutter is actuated, it is typically rotated through an arc
of X degrees in a first direction and then rotated in the opposite
direction through the same arc. Once this first rotation cycle is
complete, the motor driving the cutter repeats this rotational
pattern.
[0007] Often, during the course of a single surgical procedure, the
surgeon will want to apply two or more different cutting
accessories to the surgical site in order to accomplish the
procedure. Typically, the surgeon will use a single handpiece to
actuate these different cutting accessories. Each time the surgeon
attaches a different type of cutting accessory to the handpiece, it
may be necessary for the surgeon or other operating room personnel
to reconfigure the surgical system used to drive the cutting
accessory to set it for the specific characteristics of that
accessory. When surgical personnel have to do this during the
course of a surgical procedure, it can increase the overall time it
takes for the procedure to be performed. This is contrary to one of
the goals of modern surgery which is that it is desirable to
perform a surgical procedure as quickly as possible in order to
hold the overall time a patient is kept under anesthesia to a
minimum.
[0008] Moreover, having to have an individual in the operating room
set the surgical system to the operating characteristics of the
cutting accessory that the system is being used to operate
introduces the possibility that, due to human error, these
characteristics will be improperly entered.
[0009] There have been some efforts at providing cutting
accessories with type-identifying indicators, typically magnets.
The handpieces to which these accessories are attached are provided
with sensors. These sensors detect the presence/absence of the
magnets and generate signals representative of what was sensed back
to the control console. The processor in the control console, based
on the signals from the handpiece sensors, then configures the
system.
[0010] The above system, while of some utility, only provides a
limited amount of data about the cutting accessory attached to the
system handpiece. This is because, due to space considerations,
only a limited number of indicators can be mounted to a cutting
accessory and only a limited number of sensors can be fitted in the
head end of the handpiece designed to actuate the accessory. For
example, known commercial systems of this design have handpieces
with two sensors. Each sensor is designed to detect the
presence/absence of a separate cutting accessory-mounted magnet.
Thus, these systems simply provide 2 bits of data. Even if it were
possible for the number of magnets in the cutting accessories and
the number of complementary handpiece sensors to be doubled, the
resultant system would only be able to provide 4 bits of accessory
specific data.
[0011] Thus, in the current systems, the indicators mounted to a
cutting accessory are only employed to provide data that describes
a basic operating characteristic of the accessory or that describes
its type. For example, the indicator may be employed to describe
basic speed and torque ranges of the cutting accessory or, for
example, that the accessory is a burr. Regardless of the specific
nature of this data, the control console processor, uses the data
to reference complementary control data in a look-up table or other
circuitry internal to the control console. The actual regulation of
the handpiece is controlled by reference to this previously stored
characteristic-data.
[0012] Thus, in the foregoing cutting accessory recognition system,
the actual control of the handpiece is based on operating
parameters that have been previously loaded into the control
console. If a new accessory is provided that has operating
characteristics different than those that have been loaded into the
control console, the console will not automatically configure
itself to operate the handpiece in accordance with those
parameters. In order for this control to be accomplished, the
control console has to be loaded with the new operating
characteristic data. Moreover, given the limited amount of data
that can be read from the indicators of the current systems, these
data may be insufficient to provide all the information a control
console could use to regulate its operation based on the
characteristics of the attached cutting accessory.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1 depicts the basic system of this invention;
[0014] FIG. 2 is a cross-sectional diagram of a cutting accessory
seated in the distal end of a handpiece of this invention;
[0015] FIG. 3 is a block diagram of the circuitry internal to the
control console, the handpiece, and the cutting accessory that is
used to store and read data from the accessory that describes the
characteristics of the cutting accessory;
[0016] FIG. 4 depicts the contents of the memory internal to the
cutting accessory;
[0017] FIG. 5 is a flow chart of how the control console
periodically reads the contents of the memory of the cutting
accessory and reconfigures the operation of the system based on the
retrieved data;
[0018] FIG. 6 depicts how the control console periodically
determines whether or not a particular cutting accessory attached
to the handpiece has been used for a time period equal to the
useful lifetime of the handpiece;
[0019] FIG. 7 is a cross-sectional view of an alternative handpiece
and cutting accessory of this invention;
[0020] FIG. 8 is a cross-sectional view of locking collet of the
handpiece of FIG. 7;
[0021] FIG. 9 is a plan view of the hub of the cutting accessory of
FIG. 7;
[0022] FIG. 10 is a cross-sectional view of the coil seal of the
cutting accessory of FIG. 7;
[0023] FIG. 11 is a perspective view of the coil seal of the
cutting accessory of FIG. 7;
[0024] FIG. 11A is a perspective view of the cutting accessory tag
assembly;
[0025] FIG. 12 is a perspective view of a partially assembled
alternative handpiece of this invention in which a cutting
accessory hub is shown coupled to the handpiece;
[0026] FIG. 13 is a front view of the handpiece and cutting
accessory hub of FIG. 12;
[0027] FIG. 14 is a cross sectional view of the handpiece and
cutting accessory hub taken along line 14-14 of FIG. 13;
[0028] FIGS. 15A and 15B are, respectively, perspective and cross
sectional views of the handpiece coil housing;
[0029] FIG. 16 is a plan view of one coil assembly of this
invention;
[0030] FIG. 17 is a plan view of the outer hub of FIG. 12;
[0031] FIG. 18 is a cross sectional view of the outer hub taken
along line 18-18 of FIG. 17;
[0032] FIG. 19 is a perspective view of a chip-and-coil
subassembly, a tag, of this invention;
[0033] FIG. 20 is a block diagram view of an alternative version of
this invention;
[0034] FIG. 21 is a block diagram depiction of how this invention
may be integrated in a surgical navigation system;
[0035] FIG. 22 is a cross sectional view of a cutting accessory of
the version of this invention depicted in FIG. 21;
[0036] FIG. 23 is a flow chart depicting how the control console
determines the extent to which a particular cutting accessory is
worn;
[0037] FIG. 24 is a block diagram of the inside of the control
console depicting how separate controllers regulate the actuating
of handpieces and the reading of data from the NOVRAMs integral
with the cutting accessories attached to the handpieces;
[0038] FIG. 25 is flow chart depicting an alternative process by
which data in a cutting accessory NOVRAM are read;
[0039] FIG. 26 is a flow chart depicting an alternative process by
which data in a cutting accessory NOVRAM are read and the control
console configured to energize the handpiece to which the cutting
accessory is attached;
[0040] FIG. 27 is a flow chart depicting how the integrated cutting
accessory and implant recognition system of this invention can be
used to facilitate the performance of image guided surgery;
[0041] FIG. 28 is a diagrammatic illustration of a case, such as a
sterilization case or a trial case, in which components used to
facilitate the performance of a surgical procedure are held;
[0042] FIG. 29 is a flow chart depicting how the integrated cutting
accessory and implant recognition system of this invention can be
used to facilitate the inventory of components used during the
performance of a surgical procedure;
[0043] FIG. 30 is a block diagram of how the information generated
by the integrated cutting accessory and implant recognition system
of this invention are transferred to other components of a medical
facility data information network; and
[0044] FIG. 31 is a block diagram of the circuitry internal to a
cordless powered surgical tool and a cutting accessory that is used
therewith.
DETAILED DESCRIPTION
[0045] FIG. 1 depicts the surgical system 20 of this invention.
System 20 includes a surgical handpiece 22 that is used to actuate
a cutting accessory 24 that is removably attached to the handpiece.
Internal to the handpiece is a motor 26 (FIG. 2) that is actuated
to drive the cutting accessory 24. The handpiece 22 is removably
attached to a control console 28 by a flexible cable 30. The
control console 28 contains circuitry that is used to supply
energization signals to the handpiece motor 26. The regulation of
these energization signals is controlled by a microprocessor,
controller 70 (FIG. 3), internal to the control console 28.
Internal to the handpiece 22 or the cable 30 is a NOVRAM 32. (When
the NOVRAM 32 is in the cable 30, the cable is integrally attached
to the handpiece 22.) The NOVRAM 32 contains data that describes
the operating characteristics of the handpiece 22. These data
include: information that identifies the type of handpiece;
information that describes the operating characteristics of the
handpiece motor; the identification of the type of output signals
provided by any sensors internal to the handpiece; and information
useful for correcting the signals produced by the handpiece sensors
to correct for their individual calibration characteristics. More
information on the types of data contained in the handpiece NOVRAM
32 and how this information is used to regulate the operation of
the handpiece 22 by the system 20 is found in U.S. Pat. No.
6,017,354, which is, again, incorporated herein by reference.
[0046] FIG. 1 further includes disposable tubing set 31. The tubing
set 31 includes tubing 33 and a cartridge 35. A portion of the
tubing 33 extends through and is secured to the cartridge 35. The
cartridge includes an identification chip 37.
[0047] A first end of the tubing 33 is secured to and receives
irrigation fluid, such as saline from an IV bag 39. The cartridge
35 is mounted onto the control console 28. A positive displacement
pump (not shown) of the control console pumps the solution to a
second distal end of the tubing 33 to irrigate a surgical site. The
tubing 33 is adjacent an irrigation/cutting handpiece 41. A
flexible cable 30a connects the handpiece 41 to the control console
28. The tubing 33 is positioned adjacent to the entire length of
the cable 30a. A cutting saw 43 is located at a distal end of the
handpiece 41. Other cutting elements can be utilized in place of
the saw 43.
[0048] The cartridge 35 can be any structure designed for
securement to the control console. In some embodiments, the tubing
set 31 comprises only tubing 31 and an identification chip 37. In
this instance, the tubing 33 is secured to the control console 28
so that the pump can pump irrigation fluid to the distal end of the
tubing.
[0049] In operation, the user of the irrigation/cutting handpiece
41 actuates the cutting saw 43. Power is supplied to the cutting
saw via cable 30a. When the cutting saw 43 is actuated, tubing 33
provides irrigation fluid to the surgical site.
[0050] When the cartridge 35 is installed onto the console 28, a
coil (not shown) mounted on the console adjacent the cartridge
reads data from the identification chip 37. The data provides the
diameter, size and any other relevant properties for the tubing 33.
The control console 28 then controls the positive displacement pump
to provide a proper flow rate for the irrigation fluid being
applied to the surgical site during cutting. Thus, a user need not
manually set specific control values for the pump.
[0051] Since the tubing set 31 is disposable, typically only data
is read from the identification chip 37. However, in some
embodiments data is sent to the chip 37 indicating that the tubing
set has been used and must be disposed of.
[0052] In some embodiments, no cartridge 35 is present. The tubing
33 is wrapped or otherwise configured to the pump, which is
preferably mounted onto the control console 28. In this instance
the identification chip 37 is mounted directly to the tubing 33,
which comprises of itself, the tubing set 31. However, the
identification chip 37 must be positioned adjacent a detector coil
connected to the control console 28.
[0053] FIG. 2 illustrates the distal end of the handpiece 22 and
the proximal end of the cutting accessory 24 of this invention. (In
this application, "distal" is used to refer to a portion of a
component located away from a surgeon/towards a surgical site;
"proximal" refers to a portion of a component located towards the
surgeon/away from the surgical site.)
[0054] The handpiece 22 has a housing 34. Motor 26 is disposed in
the housing 34. The motor 26 has a rotated-sleeve shaped shaft 36
to which a number of magnets 38 are attached. Motor 26 also
includes a set of windings 40 that are secured to the inner wall of
housing 34 that surround magnets 38. The distal end of housing 34
is open and dimensioned to receive the proximal end of cutting
accessory 24.
[0055] The cutting accessory 24 includes an outer hub 44 formed of
plastic. Outer hub 44 is formed with tabs 46. Tabs 46 seat in
complementary notches 48 formed in handpiece housing 34 so as to
hold the hub in one place in the housing. A locking mechanism
integral with the handpiece, (not illustrated) has members designed
to engage the outer hub 44 so as to releasably secure the cutting
accessory to the handpiece. For example, some handpieces are
provided with a set of ball bearings that are releasably pressed
against an opposed outer surface of the outer hub. The Applicant's
Assignee's U.S. Pat. No. 6,312,441, POWERED SURGICAL HANDPIECE FOR
PERFORMING ENDOSCOPIC PROCEDURES, issued Nov. 6, 2001 and
incorporated herein by reference discloses how one such locking
assembly works. Alternatively, spring arms may be releaseably held
against the outer hub. The Applicant's Assignee's U.S. Pat. No.
5,192,292, SURGICAL APPARATUS FOR ARTHROSCOPIC SURGERY, issued Mar.
9, 1993 and incorporated herein by reference discloses one version
of this type of locking assembly. Thus, the actual type of
handpiece locking assembly that holds the cutting accessory to the
24 to the handpiece 22 and complementary outer hub geometry may
vary.
[0056] An outer tube 50 extends distally forward from the outer hub
44 away from the handpiece 22. The cutting accessory 24 also
includes an inner tube 52 that is disposed inside the outer tube
50. The distal head end of the inner tube 52, (end not illustrated)
is provided with some type of cutting member to selectively shape
and/or remove the tissue to which it is applied. The inner tube 52
extends through both the outer tube 52 and the outer hub 44. The
proximal end of the inner tube is attached to an inner hub 56,
sometimes referred to as a drive coupling, that is located against
the proximal facing face of the outer hub 44.
[0057] When the cutting accessory 24 is fitted in the handpiece,
inner hub 56 is located inside a cavity located in the distal end
of the handpiece housing 34. The proximal end of the inner tube 52
and inner hub 56 is seated over the open distal end of handpiece
shaft 36. Complementary teeth on the shaft 36 and the inner hub 56
releasably hold the inner hub to the shaft so that the inner hub
will rotate in unison with the shaft 36 (teeth not
illustrated).
[0058] An identification sleeve 60 is fitted over the outer hub 44.
Sleeve 60 is formed of plastic and may provide some of the
structural strength of the outer hub 44. Internal to sleeve 60 is a
small semiconductor that functions as an identification chip 62.
Also disposed inside sleeve 44 is a coil 64. In the depicted
version of the invention, coil 64 extends annularly around sleeve
60. The ends of coil 64 are, as described below, connected to
components internal to identification chip 62.
[0059] The distal end, the head end, of handpiece housing 34 is
provided with a separate annular coil 66. The opposed ends of coil
66 are connected by conductors 63 (one shown) and cable 30 to
circuitry internal to the control console 28. Collectively, the
handpiece 22 and cutting accessory 24 are shaped so that coils 64
and 66 are in such proximity to each other that they will
collectively inductively transfer signals from/to the circuit
internal to the control console to/from the circuit internal to the
identification chip 62. Typically, the handpiece housing 34 is
formed of metal. Accordingly, in the illustrated versions of the
invention, coil 66 is disposed in a ring 67 formed from a plastic
that can be subjected to medical sterilization wherein the
handpiece is autoclaved at 270.degree. F., subjected to saturated
water vapor at 30 psi. One suitable plastic from which ring 67 may
be formed is a polyetherimide and glass filed plastic sold by the
General Electric Company under the trademark ULTEM. Ring 67 is
fitted in a notch, not identified, formed in an interior wall of
handpiece housing 34. The inner surface of ring 67 thus defines
part of the cavity in which the proximal end of the cutting
accessory 24 is seated. The fitting of handpiece coil 66 in ring 67
facilitates the inductive signal transfer between the handpiece
coil and the coil 64 integral with the cutting accessory.
[0060] FIG. 3 depicts, in block diagram, electrical components
internal to control console 28 of system 20 of this invention. The
control console 28 includes a controller (CNTRLR) 70 that controls
the overall operation of the system 20. Memories, represented by a
single memory 69, are also contained in the control console. These
memories contain the permanent operating instructions that are
executed by controller 70 to control the system and regulate the
actuation of the handpiece 22 and the cutting accessory 24. The
memories also temporarily store the data that is read from the
handpiece NOVRAM 32. As part of its control of system 20,
controller 70 generates energization control signals to a driver
72. The driver 72, based in part on the energization control
signals, generates energization signals that are applied to the
handpiece motor 26. Controller 70 is connected to the handpiece
NOVRAM 32 to receive from the NOVRAM the data that describes the
operating characteristics of the motor. The control console 28 also
includes a touch screen display 71. Controller 70 causes
information regarding the state of the system 20 to be presented on
the display 71. Controller 70 also causes images of buttons to be
presented on the display 71. Operating room personnel regulate the
operation of the system 20 by selectively depressing these
buttons.
[0061] Control console 28 is also connected to a modulator (MOD)
74. Modulator 74 modulates digital signals output by controller 70
so they can be inductively transferred to cutting accessory
identification chip 62. In one preferred version of the invention,
modulator 74 receives a fixed-frequency signal from an oscillator
76 internal to the control console 28. In one version of the
invention, the signal produced by the oscillator 76 is at a
frequency of 125 Khz. In another preferred version of the
invention, the carrier signal produced by oscillator 76 is at 13.56
MHz.
[0062] Modulator 74, based on the bit stream produced by the
controller 70, engages in selective amplitude shift keying (ASK) of
the carrier signal. In one form of amplitude shift keying, based on
the l's and 0's pattern that forms the bit stream, the modulator 74
selectively transmits/stops transmitting the carrier signal so as
to produce a set of variable length rectangular pulses. The
amplitude shift keyed signal generated by modulator 74 is amplified
by an amplifier 78 internal to the control console 28. The output
signal from amplifier 78 is applied to one end of handpiece coil
66.
[0063] The end of handpiece coil 66 opposite the end to which
amplifier 78 is connected is tied to a demodulator (DEMOD) 80
internal to the control console. Demodulator 80 receives the signal
that is coupled to handpiece coil 66, demodulates the signal, and
applies the output bit stream to controller 70. A typical
demodulator may include a product detector to which the carrier
signal is applied from oscillator 76. The output from the detector,
which is a multiplication of the signal from the oscillator 76 and
the coil 66, is applied to a low-pass filter, also part of the
demodulator 80. The output signal from the low pass filter is a bit
stream that is applied to the controller 70.
[0064] In FIG. 3 oscillator 76 is also shown as connected to
controller 70. This is because the signal produced by the
oscillator is also used to regulate the writing out of the bit
stream that is applied to the modulator 74 and the reading in of
the bit stream generated by the demodulator 80.
[0065] The identification chip 62 includes a small controller and
an electronically programmable memory (.mu.C & MEM) 84.
Controller/memory 84 is capable of storing approximately 1 k bits
of data. The controller integral with controller/memory 84 is
capable of controlling the writing of data into its complementary
memory section and the writing out of the contents of the memory.
There is also a modulator/demodulator (MOD DEM) 86 fabricated
integrally into chip 62. Modulator/demodulator 86 contains the
components necessary to demodulate the ASK signal coupled to coil
64 and apply the resultant bit stream to controller/memory 84.
Modulator/demodulator 86 also accepts the bit stream output from
the controller/memory 84 and produces an ASK modulated signal based
on this bit stream. A clock 88 fabricated into chip 62 produces a
clock signal that the modulator/demodulator 86 uses as a basis for
producing a carrier signal produced an ASK modulated signal.
[0066] A capacitor 83 is also fabricated integrally with chip 62.
More particularly, chip 62 is designed so that coil 64 is connected
across the opposed ends of capacitor 83. When a signal is applied
to chip 62 through coil 64, the energy in the high portion of the
signal is stored in capacitor 83. This energy is applied directly
to a power regulator 89 to function as an energization signal. The
power regulator 89 supplies this energization signal to the other
sub-circuits internal to the chip 62. (Connections between power
regulator 89 and other components of chip 62 not shown.)
[0067] In FIG. 3, coil 64 is shown as being integrally part of chip
62. This is one option for the invention. However, as discussed
above, it is anticipated that in many versions of the invention,
chip 62 and coil 64 will be separate components.
[0068] FIG. 4 illustrates some of the different types of data
stored in the tag controller/memory 84. These data include a serial
number specific to the cutting accessory 24 with which tag 62 is
integral, field 90. This number may also include a special
authorization code, the purpose of which is described hereinafter.
There is also a field with data that indicates cutting accessory's
24 type, field 92. For example, the data in field 92 may indicate
that the cutting accessory is a burr that has a head with a
particular diameter. Field 94 within controller/memory 84 contains
data indicating a preferred speed at which the cutting accessory
should be operated. Data indicating the maximum speed at which the
cutting accessory should operate is contained in field 96. The
maximum operating torque the cutting accessory should develop is
indicated by data in field 98.
[0069] Field 102 contains data that indicates the preferred mode of
operation of the cutting accessory. For example, if the cutting
accessory 24 is a cutter, the most common mode of its operation is
oscillatory. Alternatively, if the cutting accessory 24 is a burr,
the preferred mode of operation is unidirectional. Stopping torque
data is contained within a field 104. The stopping torque data is
data used to regulate the deceleration of the handpiece motor
26.
[0070] Controller/memory 84 also contains data fields that are
written to by the control console controller 70. One of these data
fields is a date/time used field 106. Field 106 is used to store
data indicating if and when the cutting accessory 24 was previously
used. Specifically, during loading of basic information into the
controller/memory 84, field 106 is loaded with flag data indicating
that it has not been previously used. As described below, once the
cutting accessory 24 is used, the controller 70 writes into field
106 an indication of when the use occurs.
[0071] A set of data indicating for how long the cutting accessory
can be used is loaded into a MAX USE TIME data field 108 in
controller/memory 84. This particular data represents how long a
surgeon can expect to use the cutting accessory 24 before the
cutting surfaces become worn to the level at which they may not
efficiently cut tissue. The length of time contained in field 108
may be based on empirical studies indicating how long an accessory
can be used before its cutting surfaces become excessively worn.
The MAX USE TIME field 108 is loaded with data specifying this time
period when the other permanent accessory-describing data are
loaded into controller/memory 84. The controller/memory 84 also
includes a TIME USED field 110. Data representative of the amount
of time the cutting accessory has been used is stored in TIME USED
field 110 by control console controller 70. A WEAR PROFILE field
112 contains data indicating the extent to which the cutting
accessory has been worn during its use.
[0072] The system 20 of this invention is initially configured for
operation by connecting the handpiece 22 to the control console 28.
Controller 70 reads the data in the handpiece NOVRAM 32, stores
these data in memory 69 and initially configures the system 20 to
operate based on the data contained in the NOVRAM. Handpiece NOVRAM
32 also contains a data field, (not illustrated), that indicates
whether or not the cutting accessories attached to the handpiece 22
may contain an identification chip 62. If this data indicates no
such chip may be present, system 20 controls the actuation of the
handpiece 22 based on the configuration data contained in NOVRAM
32.
[0073] If, however, NOVRAM 32 indicates that the cutting accessory
may contain a chip 62, controller 70 executes a read request, step
120 in FIG. 5, in which it reads the data in the chip
controller/memory 84. In step 120, controller 70 generates a read
request to chip 62. This request is converted into an ASK signal by
modulator 74 and applied to the chip through coils 64 and 66. If a
chip 62 is attached to cutting accessory 24, the chip, in response
to the read request, writes out the stored data in its
controller/memory 84 through coils 64 and 69 and demodulator 80 to
controller 70. Controller 70 stores this data in appropriate fields
within control console memory 69.
[0074] If the cutting accessory 24 does not include a chip 62,
controller 70 does not receive any data in response to its read
request. If this event occurs, controller 70 regulates the
operation of the handpiece based on the data contained in NOVRAM
32, step not shown.
[0075] If cutting accessory chip 62 writes data to control console
controller 70, the first thing the controller does is compare the
serial number stored in chip 62 to the serial number stored from
the last cutting accessory attached to the handpiece, step 122. If
this is the first cutting accessory attached to the handpiece 22,
the serial number the controller 70 has stored will be a set of
flag data indicating that, previously, there was no attached
cutting accessory with chip.
[0076] Once it has been determined that a new cutting accessory has
been attached to the handpiece 22, step 122 may also include the
sub-step of, determining based on the identification number, if the
appropriate authorization code is present. If this code is not
present the control console 70 may prevent further operation of the
system with the attached cutting accessory 24 and/or generate a
message on display 71 indicating that an unauthorized accessory is
attached. (The sub-steps of this code determination and the steps
executed when the code is not present are not illustrated.)
[0077] If the comparison of step 122 indicates that this is the
first cutting accessory attached to the handpiece or, as discussed
below, there has been a change in the cutting accessory attached to
the handpiece, controller 70 reads and reviews the data read from
the tag data/time used field 106. Specifically, in step 123, this
data is reviewed to determine whether or not the cutting accessory
was previously used and, if so, did the use occur at a date and
time significantly before the current data and time. The data in
chip 62 may indicate that there was no previous use of the cutting
accessory. Alternatively, if the data indicates that the use of the
cutting accessory was relatively recent, within, for example, 24
hours, controller 70 interprets this data as indicating that the
use was in association with the current surgical procedure.
Controller 70 interprets either of these two states as being ones
in which use of the cutting accessory can continue normally.
[0078] However, in step 123, controller 70, based on the data read
from field 108, may determine that the cutting accessory 26 was
previously used at a time other than during the current surgical
procedure. If this determination is made, controller 70 generates a
warning message indicating this information on the console touch
screen display 71, step 124. This provides the surgeon with an
indication that the cutting accessory was used. In step 124, the
controller presents a button on display 71 the surgeon must depress
to acknowledge the used state of the cutting accessory before it
allows the surgeon to actuate the handpiece 22.
[0079] Once it is determined that the cutting accessory 24 was not
previously used, or the surgeon has acknowledged the previous use,
controller 70 reconfigures the operation of the system, step 126.
In step 126, based on the data read from the controller/memory 84
integral with the cutting accessory 24, controller 70 configures
the system for operation with the cutting accessory. Specifically,
the system 20 is set so that at least initially the handpiece motor
will operate at the speed indicated by the data in preferred speed
field 94. The forward/reverse/oscillate mode of the motor is set to
that specified in operating mode field 102. Thus, in step 126, the
data from the cutting accessory chip 62 is used to override data
that supersedes the data in handpiece NOVRAM 32 that describes how
the system should be configured. Not illustrated is the memory
integral with controller 70 in which the data from chip 62 are
stored and used as reference data to control the operation of the
system 20.
[0080] In step 126, based on the data contained in the accessory
type field 92, controller 70 causes console display 71 to present
an indication of the accessory's type. Controller 70 further
configures the system to prevent the surgeon for generating
commands that allow the handpiece motor to be actuated at a speed
greater than that specified in the maximum speed field 96.
(Alternatively, controller 70 may simply require the surgeon to
acknowledge a warning before allowing the surgeon to operate the
handpiece above the maximum speed for the associated accessory 24.)
System 20 is further configured by controller 70 to prevent the
generation of energization signals from being applied to the
handpiece motor that would cause the cutting accessory 24 to
develop more torque than it is allowed to develop according to the
data in maximum torque field 98. The system is further configured
so that during deceleration of the handpiece motor, the motor will
not be subjected to torque in excess of the braking torque
specified in stopping torque field 106.
[0081] Controller 70 also updates the data in the controller/memory
84 of the cutting accessory 24, step 128. More particularly, in
step 126, the date and time the cutting accessory 24 was attached
to the handpiece 22 are written into the date/time used field
106.
[0082] Once steps 126 and 128 are executed, the system is ready for
operation. The control console will, based on commands entered by
the surgeon, apply energization signals to the handpiece motor 26
so that it will run in the appropriate mode and in appropriate
speed for that attached cutting accessory 24. This operation of the
system is represented by continued operation step 130 of FIG.
4.
[0083] Throughout the operation of the system 20, controller 70
will periodically execute read request/data read and serial number
comparison steps 120 and 122, respectively. In some versions of the
system, steps 120 and 122 are reexecuted once every 0.2 to 1.0
seconds during periods of time the handpiece is not being actuated.
If the serial number comparison step 122 indicates that serial
number associated with the cutting accessory 24 is unchanged,
controller 70 recognizes this state as indicating that the same
cutting accessory remains attached to the handpiece 22. If this
condition is detected, controller continues to allow the system to
operate in accordance with its current configuration; step 130 is
continually executed.
[0084] However, serial number comparison step 122 may indicate that
there has been a change in cutting accessory serial numbers since
the step was previously executed. This condition is recognized by
controller 70 as indicating that a different cutting accessory 24
is attached to the handpiece 22. If this is the detected system
state, controller 70 reexecutes steps 123, 126 and 128, and, if
necessary, step, 124, before reexecuting step continued operation
step 128. When continuing operation step 128 is reexecuted, the
system 20 has been reconfigured to actuate the handpiece in
accordance with the characteristics of the newly attached cutting
accessory 24.
[0085] Controller 70 also monitors the amount of time the cutting
accessory 24 is actuated. Specifically, controller 70 maintains an
internal timer in which a time count is maintained indicating how
long the cutting accessory attached to the handpiece 22 is
actuated. In some versions of the invention, after each time the
motor is deactivated, step 138 of FIG. 6, the controller 70
performs this monitoring. Specifically, after the motor is
deactivated, controller 70 performs a step 140 in which the
controller writes into the TIME USED field 110 of the cutting
accessory controller/memory 84 data indicating the total time the
cutting accessory has been used. These data are determined based on
the data read from the TIME USED field 110 when the cutting
accessory was first attached to the handpiece as well as the
elapsed time of use for the accessory stored by the controller 70.
This step 140 may be integrated into the first reexecution of step
120 after the motor is deactivated. Alternatively, step 140 may be
executed as a separate write data step after the motor is
deactivated. As part of step 140, the elapsed time count held by
the internal timer is zeroed out.
[0086] Controller 70 then determines if the total time the cutting
accessory has been used is less than the time period specified in
the MAX USE TIME field 108 of the cutting accessory 24, step 142.
In some versions of the invention, it is believed the useful
lifetime for a cutting accessory will be between, for example, 30
and 120 minutes. If the total use time is less than the maximum
recommended use time, controller 70 allows the system to operate as
before, step 144. If, however, the total time of use is greater
than the specified maximum recommended use time, controller 70
presents a warning notice and an acknowledgement button on the
touch screen display, step 146. The surgeon must acknowledge that
the cutting accessory 24 has been used for a time greater than its
specified maximum use before the controller allows the system to
continue to actuate the cutting accessory 24.
[0087] Chip 64 of cutting accessory 24 of this invention contains a
significant amount of data that describes the operating
characteristics and state of the cutting accessory. The control
console 28 of this system automatically both reads this data and
periodically updates it. The control console 28, based on the data
read from chip 64, configures the system so it will operate in an
appropriate manner given the specific characteristics of the
specific attached cutting accessory. Specifically, the control
console controller 70 configures the system so that, at least
initially the handpiece motor will run at the preferred speed and
in the preferred mode for the cutting accessory. The system is also
configured to prevent the cutting accessory from being driven above
its specific maximum operating speed, from developing torque beyond
its design limit and from being subjected to excessive braking
torque. This configuration of the system occurs without human
intervention. Consequently, the possibility that human error could
result in the incorrect configuration of the system 20 for the
cutting accessory 24 attached to it is substantially
eliminated.
[0088] The system of this invention provides the surgeon with an
indication of whether or not the cutting accessory attached to it
was previously used. This provides the surgeon with an indication
that the cutting accessory may be worn and, therefore, will not be
able to satisfactorily perform the intended surgical procedure.
[0089] System 20 of this invention also, during the surgical
procedure, provides the surgeon an indication that a cutting
accessory has been used for a period equal to its intended
lifetime. This information is supplied to the surgeon to inform
him/her that the cutting accessory, even if new when installed, may
be worn to the level of reduced efficiency. Thus, the surgeon, upon
receiving this information, can decide whether or not to continue
using the current accessory or replace it with a new one.
[0090] Moreover, the handpiece 22 of this invention is constructed
so that ring 67, which functions as the inner wall in which coil 66
is contained is plastic and the handpiece housing 34, which forms
the outer containment wall for the coil, is formed of metal. As a
result of this construction, the inductive field generated by coil
66 is localized within the cavity in the distal end of the housing
34 in which cutting accessory 24 is seated. The inductive field
generated by coil 66 does not extend beyond the surface of housing
34. This substantially eliminates the possibility that if the
handpiece of this invention was placed on a surface next to a
cutting accessory that is provided with an identification chip 64,
the handpiece coil 66 will not establish an inductively coupled
circuit so as to provide the control console 28 with a false
indication that the handpiece is actually connected to the adjacent
cutting accessory.
[0091] It should be recognized that the foregoing description has
been limited to one preferred version of the invention. Other
versions of the invention may vary from what has been described.
For example, in some versions of the invention, the coils integral
with the cutting accessory and handpiece may not extend
circumferentially around the longitudinal axis of these components.
Instead, these coils may be positioned to be aligned longitudinally
with the longitudinal axes of the cutting accessory and
handpiece.
[0092] Also, in some versions of the invention, the handpiece may
be constructed so that the material in which coil 66 is encased is
metal. Thus, in these versions of the invention, the presence of
coil 66 does not require the handpiece to have a non-metallic
component that is directly exposed to the rigors of
sterilization.
[0093] Moreover, the data contained within the chip 62 of the
handpiece may vary from what has been described. For instance, in
some versions of the invention, the handpiece of the invention may
not include a NOVRAM. In these versions of the invention, chip 62
contains all, or substantially all, of the handpiece characteristic
data that was otherwise stored in the handpiece NOVRAM. This data
is, however, specific to the operating characteristics of the
cutting accessory 24 with which the chip 62 is integral. Once the
cutting accessory 24 is attached to the handpiece 22, controller 70
configures the system based on the data read from the chip 62.
[0094] Also, in some versions of the invention, it may not be
possible for the cutting accessory to overwrite new data into any
data field. In these versions of the invention, the chip 62 has
empty data fields when it is installed in the cutting accessory 24.
Then, during operation of the system 20, controller 70 writes the
new data that needs to be written into chip 62 into the previously
empty controller/memory data fields. During the read out of the
contents of the controller/memory 84, step 120, all the data are
read out. The controller is configured to recognize the last data
in a set of data fields, for example in a set of time used fields,
as being the most current version of the data.
[0095] FIG. 7 depicts an alternative handpiece 150 and cutting
accessory 152 constructed in accordance with this invention.
Specifically, the handpiece 150 has a metal body 154 to which a
plastic locking collet 156 is attached. Internal to the body is a
motor, not illustrated, from which a drive shaft 158 extends. The
cutting accessory 152 has a static hub 160 that is releasably held
to the handpiece 150 by a locking assembly mounted in the locking
collet 156. The locking assembly, while not fully illustrated,
includes a tongue 157 that is releasably seated in a recessed
surface of hub 160. A tubular housing or outer tube 162 extends
from hub 160. Located proximal to hub 160 and within the handpiece
150 is a drive coupler 164. Drive coupler 164 has a proximal end
designed to engage a coupling member integral with drive shaft 158
so that the shaft and coupler rotate in unison. A drive shaft, or
inner tube 166 is secured and extends distally from the drive
coupler 164. The drive shaft 166 extends through hub 160 and into
housing 162.
[0096] An RFID chip 170 (FIG. 11A) is secured to hub 160. A coil
172 is connected to chip 170. A coil 174 is mounted to handpiece
body 154 with chip 170 through coil 172.
[0097] Handpiece body 154 is generally elongated in shape and has
elongated bore 177. Bore 177 is the space in which the handpiece
motor as well as the proximal end of the cutting accessory 152 are
seated. The distal end of body 154 is shaped to have a ring shaped
head 178 that defines a counterbore 180 that opens into bore 177.
Counterbore 180 opens into a main bore in the body in which the
motor is housed. A suction bore 182 branches off of bore 177.
Suction is drawn through the cutting accessory 152 through the
suction bore 182. Partially seen in FIG. 7 is a valve bore 184 that
interests the suction bore. A valve (not illustrated,) is disposed
in the valve bore 184, for regulating the suction flow through the
cutting accessory 152 and the handpiece 150.
[0098] Handpiece body 154 is further formed so that the distal end
portion of the inner wall of head 178 has an inwardly directed step
186. Coil 174 is disposed in the space defined by step 186. In some
versions of the invention, coil 174 is in the helical wrap of wire.
The wire may be wrapped around a thin film of polyamide material
that supports the wire. In alternative versions of the invention,
coil 174 is formed on flex circuit. The flex circuit is placed in
the space adjacent step 186.
[0099] Conductors 188 that connect coil 174 to downline components
in the handpiece 150 are seated in a separate bore 189 formed in
the housing body 154. Specifically, internal to the handpiece is an
impedance matching circuit that establishes the impedance of the
circuit internal to the handpiece to 50 Ohms to facilitate the
exchange of the signals between control console 28 and coil 174
over a 50 Ohm impedance coaxial cable.
[0100] Locking collet 156, seen best by reference to FIG. 8, has a
tubular base 190. Extending distally from base 190, collet 156 is
shaped to have a head 192 that has a larger outer diameter to base
190. The moving components of the locking assembly that engage hub
160 are mounted in base 190.
[0101] When the handpiece 150 is assembled, collet base 190 is
fitted in counterbore 180 so that the outer wall of the base abuts
the inner wall of body proximal to step 186. An O-ring 194 is
located around the interface where the proximal end of collet base
190 abuts the handpiece body 154. Specifically, the collet base 190
is formed to define a groove 196 that extends circumferentially
around the distal end of the outer perimeter of the proximal end of
the base 190. In order to provide structural strength for the
collet, it will be observed that the proximal end is located
inwardly of the more distal sections of the base. The handpiece
body is shaped to define an annular stepped surface 198. The
stepped surface is the surface from which the body head 178
extends. Stepped surface 198 is the surface against which the
proximal facing end of collet base 190 extends. Housing body 154 is
further formed so that there is a small grooved surface 202 within
stepped surface 198. Specifically, grooved surface 202 extends
annularly around stepped surface 198 adjacent the outer perimeter
of the stepped surface. The O-ring 194 is thus seated in the
grooved surface 202 of the handpiece body 154 and groove 196 of
collet 156.
[0102] Locking collet 156 is further formed to have a generally
cylindrical outer ring 204 that extends proximally from head 192.
Outer ring 204 thus extends circumferentially around and is spaced
away from the distal end of locking collet base 190.
[0103] When the handpiece 150 is assembled, coil 174 is seated in
the annular space between the outer wall of collet base 190 and the
inner wall of outer ring 204. In other words, this annular space
forms an enclosure for holding coil 174. The collet 156 is fitted
to body 154 so that the outer surface of collet outer ring 204 is
disposed against the inner wall of the base head 178.
[0104] As part of the process of assembling the handpiece 150, an
adhesive, such as a silicone adhesive, is placed between the
opposed surfaces of the body head 178 and collet outer ring 204. A
fraction of this adhesive collects in two annular channels 210
formed in the handpiece body head 178. Upon the curing of this
adhesive in the channels, the adhesive forms two O-rings 211
between the body 154 and collet 156. These O-rings 211 thus prevent
fluid flow from outside the handpiece 150 to coil 174.
[0105] Hub 160, which is formed of rigid plastic, is now described
by reference to FIGS. 9, 10 and 11. The hub 160 is constructed to
have a sleeve-shaped base 220. The base 220, it will be observed,
is formed with two diametrically opposed, generally rectangularly
shaped openings 221. Extending forward from base 220 and formed
integrally therewith is a substantially solid head 222. While head
222 is substantially solid, the hub 160 is formed so that a bore
224 extends axially through the head. Housing 162 is mounted in
bore 224 in any conventional manner to extend forward from head
222.
[0106] A generally tube-shaped coil seal 226 is disposed in hub
base 220. Coil seal 226 is formed from flexible sterilizable
material. In one version of the invention, coil seal 226 is formed
from a silicon rubber that has 55 Shore A durometer hardness. The
coil seal 226 is shaped so as to have a first distal end section
228 that has a constant outer diameter and inner diameter.
Extending proximally from the distal end section 228, the coil seal
226 has a main section 230. Main section 230 has the same inner
diameter as distal end section 228 and a smaller outer diameter.
The coil seal is further formed so as to define a generally
rectangular recess 232 in the outer surface of main section 230.
Located proximal to main section 230, the coil seal 226 has a
locking section 234. The inner and outer diameters of locking
section 234 are the same as those of the distal end section
228.
[0107] The locking section 234 of the coil seal is further formed
to have two diametrically opposed lock tabs 236. Each lock tab 236
extends radially outwardly from the outer surface of the locking
section 234. The locking section also has two diametrically opposed
stop tabs 238 that extend inwardly from the inner wall of the lock
section. In the depicted version of the invention, each stop tab
238 is radially aligned with a separate one of the lock tabs
236.
[0108] Coil seal 226 is further formed to have a tail section 240
that extends rearwardly from the locking section and that forms the
proximal end of the seal. The tail section 240 is formed to define
two annular spaced apart ribs 242 and 244 that extend
circumferentially around coil seal 226. Both ribs 242 and 244
extend beyond the outer diameter of the seal locking section 234.
In the depicted version of the invention, the diameter of the
circle subtended by the more proximal of the two ribs, rib 244, is
less than the diameter subtended by the other rib, rib 242. Tail
section 240 is further formed to have an inner wall that is
outwardly flared.
[0109] When a cutting accessory 152 of this version of the
invention is assembled, the RFID chip 170 is seated in seal recess
232. Coil 172 is wound over the reduced diameter outer surface of
seal main section 230. In some versions of the invention, seen in
FIG. 11A, the chip 170 is mounted on a small flex circuit 171; the
coil 172 is a conductive trace formed on the flex circuit 171.
After manufacture of the flex circuit 171, the flex circuit, with
the chip 170 mounted thereon, is wrapped in cylinder over seal main
section 230.
[0110] The RFID chip-coil-and-seal assembly is fitted in hub base
220. Thus both the RFID chip 170 and coil 172 are disposed between
the inner wall of the hub base and the outer surface of coil seal
226. Owing to the relative dimensions of hub 160 and coil seal 226,
the outer surfaces of the seal distal end and locking sections 228
and 234, respectively, press against the inner wall of the hub base
220. This contact forms a seal around chip 170 and coil 172. Thus,
in most preferred versions of the invention, there is no need to
employ an adhesive or other chemical to provide a moisture barrier
around the chip 170 and coil 172.
[0111] As part of the insertion of the coil seal 226 into the hub
160, lock tabs 236 are seated in hub base openings 221. The seating
of the lock tabs 236 in openings 221 serves to hold the coil seal
226 to the hub 160.
[0112] When the coil seal 226 is so attached to hub 160, tail
section ribs 242 and 244 are located proximal to the proximal end
of the hub. When the assembled cutting accessory 152 is fitted in
the handpiece 150, ribs 242 and 244 abut the inwardly flared
surface of the handpiece collet base 190. The ribs thus function as
a seal that prevents leakage from the suction channel to the coil
cavity or the outside environment.
[0113] It will further be observed that the distal end of driver
coupler 164 is formed with a head 245 that has a relatively large
outer diameter. When cutting accessory 152 is assembled, the driver
coupler and rotating shaft subassembly is moved past coil seal 226
in hub bore 224. Owing to the dimensioning of the components, the
drive coupler head 245 abuts the coil seal stop tabs 238. Owing to
the compressibility of the material from which the coil seal is
formed, a small amount of force will compress the stop tabs 238 to
allow the complete insertion of the drive coupler and rotating
shaft. After assembly, if the cutting accessory 152 is held
vertically, the drive coupler head 245 abuts the stop tabs 238.
Thus, the stop tabs prevent gravity, without any additional force,
from causing the driver coupler and rotating shaft to drop out of
hub 160.
[0114] FIGS. 12, 13 and 14 illustrate an alternative handpiece 250
and cutting accessory hub 252 of this invention. The handpiece 250,
shown in cross-section in FIG. 14, includes an elongated body 254
that has an axially extending bore 256. The center and proximal end
sections of bore 256 serve as the space in which the motor and
cable connector integral with the handpiece 250 are housed, (motor
and cable connector not shown). The distal end section of bore 256
is the space internal to the handpiece in which the cutting
accessory hub and drive coupler are received, (drive coupler not
shown).
[0115] This particular handpiece has a motor with a cannulated
rotor. Thus, suction is drawn axially from the distal end of the
rotating shaft of the attached cutting accessory, through the drive
coupler and the motor rotor by the suction pump attached to the
handpiece. Irrigation fluid is supplied to an opening in the hub
252. The irrigation fluid can also be directed through the rotating
shaft. A valve in the proximal end of body bore 256 selectively
connects the rotating shaft to either the suction pump or the
source of irrigating fluid. This valve is set by a control tab,
(not illustrated), that is positioned above a stepped surface 258
formed in the outside of body 254. The control tab displaces a
linkage rod (not illustrated), that is seated in a rod bore 259
formed in the body 254. The Applicant's Assignee's U.S. patent
application, SYSTEM AND METHOD FOR PERFORMING IRRIGATED NOSE AND
THROAT SURGERY Ser. No. 60/395,881, filed on Jul. 13, 2002, now
U.S. Pat. No. 7,318,831 B2, and incorporated herein by reference,
provides further details of the above features of this
handpiece.
[0116] A coil 260 is disposed in the distal end of body bore 256,
immediately inside the distal end opening of bore 260. Coil 260,
shown in FIG. 14 as a wrap of wires, is contained in a coil housing
262, now described by reference to FIGS. 15A and 15B. The coil
housing 262 is formed from a plastic cable to withstand
sterilization such as PEEK plastic and is generally ring-shaped.
Coil housing 262 is further formed to define a rectangular groove
264 that extends circumferentially around the outside of the
housing. Groove 264 is the space in which coil 260 is seated. The
proximal facing end of the coil housing 262 is formed to have an
annular lip 266 that extends substantially circumferentially around
the housing. Lip 266 has an outer diameter substantially equal to
the outer diameter of the more distal portions of the coil housing.
The inner diameter of lip 266 is greater than that of the rest of
the housing 262.
[0117] Coil housing 262 is further formed to have a slot 268 that
is defined by opposed spaced apart ends of lip 266. The wires
forming coil 260 extend proximally into the handpiece body through
slot 268.
[0118] When handpiece 250 is assembled, coil 260 is seated in
housing groove 264. The coil-and-housing assembly is seated in the
distal end of body bore 256. In some versions of the invention, the
coil housing 262 is adhesively secured to a lock nut 270 disposed
in body bore 256. Alternatively, coil housing 262 may be provided
with feet that press fit, snap fit or key-in-key hole slot fit into
the lock nut. In some versions of the invention, the coil housing
262 may even press fit into body bore 256.
[0119] The conductors connected to coil 260 are disposed in a bore,
signal conduit 259, formed in the handpiece body 254. Signal
conduit 259, it is observed from FIG. 14, extends generally
parallel to bore 256. The distal end of signal conduit 259 extends
diagonally into the section of bore 256 in which coil housing lip
266 is seated.
[0120] In one version of the invention, the conductors that extend
to coil 260, as well as the conductors that actually form the coil,
are formed on a flex circuit 272 now described by reference to FIG.
16. Flex circuit 272 is formed of polyamide or any other material
that can serve as a structural substrate for conductors and
electrical components. Generally, the depicted flex circuit 272 is
L-shaped. Conductive traces 274, 276 and 278 are formed on the flex
circuit 272. Two traces, traces 274 and 276 are parallel and are
located on a vertical section 273 of the flex circuit in FIG. 16.
An integrated circuit 280 is shown attached to trace 276. Circuit
280 is an impedance matching circuit to bring the impedance of the
circuit on the trace to 50 Ohms. While not illustrated, it should
be recognized that trace 274 is also attached to the integrated
circuit 280. Trace 274 also terminates a short distance above
integrated circuit 280.
[0121] Trace 278 extends from integrated circuit 280 and is the
conductive trace formed on the generally horizontal portion 284 of
flex circuit 272 in FIG. 16. The flex circuit 272 is further formed
to have a small branch section 286 that extends diagonally downward
from the end of the horizontal section 284 opposite vertical
section 273. The free end of trace 278 is formed over the branch
section 286.
[0122] When a version of the invention incorporating flex circuit
272 is assembled, section 284 of the flex circuit is wrapped in a
circular pattern at least once in coil housing groove 264. More
specifically, the flex circuit 272 is wound around the coil housing
262 so that flex circuit branch section 286 extends over section
273. Then, the free end of trace 278 is soldered or otherwise
conductively connected to the free end of trace 274. Thus trace 278
forms the handpiece coil.
[0123] The cutting accessory hub 252, now described by reference to
FIGS. 17 and 18, is formed from two plastic pieces, base 290 and
head 292. Base 290 is formed to have a proximal section 296 that
has a multisection axial bore 298. It should be understood that
bore 298 is dimensioned to receive the drive coupler and proximal
end of the rotating shaft of the cutting accessory with which hub
252 is integral. Base 290 also has a distal section 302 integrally
formed with and located forward of proximal section 296. Base
distal section 302 is formed to have a counterbore 304 that has a
diameter that is larger than the diameter of the adjacent section
of bore 298.
[0124] The hub head 292 is formed to have an axially extending
through bore 308. Bore 308 is dimensioned to receive the associated
rotating shaft. The hub head is shaped to have a generally
cylindrical, proximally located stem section 310. Collectively the
components forming hub 252 are shaped so that stem section 310 has
an outer diameter that is appreciably less than the inner diameter
of base distal end section 302.
[0125] When hub 252 is assembled, head stem section 310 is seated
in base counterbore 304. Owing to the relative dimensions of the
base 290 and head 292, when these components are so assembled an
annular coil space 312 is formed between stem section 310 and the
adjacent end wall of base distal end section 302. An RFID chip 314
and coil 316, now described by reference to FIG. 19 are seated in
this space. Specifically, the chip 314 and coil 316 are assembled
as a single unit on a flexible substrate 318. Often this assembly
is referred to as a tag. A chip from the Philips Semiconductor of
Netherlands i.Code family of chips can be employed as the chip 314.
Conductive traces that form coil 316 are formed on substrate 318.
As part of the hub assembly process, prior to the insertion of head
292 over base 290, substrate 318 is wrapped into a cylindrical
shape and inserted in base counterbore 304. The head stem section
310 is then seated in counterbore 304. It will be understood that
the base 290 and head 292 are dimensioned so that the proximal end
of the head stem section abuts the step within base 290 that
defines the base of counterbore 304.
[0126] Adhesives hold the base 290 and head 292 together. The
adhesives also create a seal around coil space 312. In some
versions of the invention, base 290 and head 292 may be provided
with tongue-and-slot members to further facilitate the mechanical
connection of these components.
[0127] When hub 252 is seated in handpiece 250, coil 316 is aligned
with the handpiece coil 260. Consequently, signals are inductively
transmitted between the coils. In preferred versions of the
invention, the voltage across the handpiece coil is approximately 5
to 25 volts, the current through the handpiece coil is
approximately 25 to 125 m Amps. Given this strength of signal, and
the fact that handpiece body 254 is metal, in preferred versions of
the invention, the inductive field established by the handpiece
coil does not extend more than 2 cm beyond the coil. In more
preferred versions of the invention, this inductive field extends a
maximum of 1 cm beyond the coil. Thus, the inductive field is
sufficient to engage in signal transfer with the coil 316 of the
hub inserted in the handpiece 250, but not the coil integral with a
cutting accessory that may be located next to the handpiece.
[0128] It should likewise be understood that the system of this
invention may have power-consuming devices other than motors. For
example, in alternative versions of the invention, the handpiece
power-consuming device may be some sort of heat generating device,
light generating device or sound/mechanical-vibration generating
device. The energy generated by these power-consuming devices are
applied to surgical sites through removable accessories different
from what has been described. The accessories of these versions of
the system of this invention are provided with tags that have
memories in which data describing the individual operating
characteristics of the accessories are stored. Clearly, different
data are contained in cutting accessories that are actuated by
devices other than motors. Also, the chip may be installed in
accessories that are not actuated. One such device is a pointer
that is attached to a tracker that is used to facilitate the
performance of surgical navigation.
[0129] It should likewise be understood that this invention may do
more than simply provide data or write data to a cutting accessory
attached to a handpiece. For example, some surgical tool systems
include intermediate attachments 320, one shown diagrammatically in
FIG. 20. These attachments 320 serve as mechanical, optical or
electrical linkages between the power generating unit internal to
the handpiece 22a and a cutting accessory 24a. In these versions of
the invention, an RFID chip 322 is mounted in a non-metallic ring
integral with the attachment (ring not illustrated). Upon
connection of the attachment 320 to the handpiece, a coil 324
integral with the attachment is in close enough proximity to the
handpiece coil 66a that there is an inductive signal transfer
between these components. Based on the data read from the
attachment, the control console 28 applies energization signals to
the handpiece power generating unit so that it operates in a manner
appropriate to the associated attachment and cutting accessories.
For example, if the handpiece power generating unit is a motor,
based on the data read from the attachment connected to the
handpiece, the power generating unit can establish a maximum speed
for the motor and/or determine the maximum torque the motor should
be allowed to develop.
[0130] In the above versions of the invention, the attachment may,
as depicted in FIG. 20, have its own coil 326 for inductive
coupling to the RFID chip 62 integral with the associated cutting
accessory 24a. In this version of the invention, the processor
internal to the control console engages in the following data
reading protocol. First, an interrogation signal is sent asking for
data from an attachment RFID chip 322. Integral with this signal is
data indicating the type of RFID chip, an attachment chip, that is
supposed to respond to the interrogation. Based on these data, only
the attachment chip 322 responds. After the data in the attachment
RFID chip 322 are read, the control console generates a second
interrogation signal. Embedded in this signal are data indicating
that an accessory chip 62 is supposed to respond to the
interrogation. Based on this interrogation signal, only the
accessory RFID chip 62 writes out data back to the processor. Thus,
the energizaton of the handpiece power generating unit is based on
data in the attachment and/or any overriding data in the cutting
accessory.
[0131] Also, as depicted in FIG. 21, in some versions of the
invention, an RFID chip may be placed in an implantable device 330
that is fitted into a patient, represented by bone section 332.
Such devices include screws, reamers that are used to bore holes
for implants, or implants themselves. Specifically the head of the
device 330 is provided with a plastic ring in which an RFID chip
336 and complementary coil 338 are seated. The data in chip 336
include such information as the preferred and suggested maximum
speeds for driving the implant into the patient. These data also
describe the physical characteristics of the implant. For example,
if the implant is a screw, the data describes: the implantable
length of the screw; the diameter of the screw; and the size of the
exposed head.
[0132] In this version of the invention, the accessory 340 used to
set the implant, as seen in FIG. 22, is provided with a coil 342.
Here, the accessory 340 is a screw driving shaft. The accessory has
a shaft 344 formed of metal. Immediately proximal to the distal
end, shaft 344 is formed to have a circumferentially extending
groove 346. Coil 342 is disposed in a plastic or other non-metallic
housing 347 seated in groove 346. Conductors, represented by a
single conductor 348, extend through a conduit 349 that extends
longitudinally through shaft 344. The conductors 348 are connected
to a coil 64b disposed in the distal end hub 44b of the accessory
340. Distal end hub 44b, in addition to including coil 64b also
includes an RFID chip 62b that contains data describing the
characteristics of the accessory 340.
[0133] When the system of FIG. 21 is used, control console 28 is
inductively coupled to both accessory chip 62b and implant chip
336. This coupling occurs immediately after the surgeon has
depressed a control member associated with the system to actuate
the handpiece 22b. This is because, at this time, the surgeon has
typically already pressed the distal end head of the cutting
accessory 340 against the adjacent head of the implant 330. Thus,
at this time the data from the implant chip 336 can be read. The
data in these chips are read by the control console 28. Based on
these data, the control console regulates the application of
energization signals to the handpiece 22b to ensure that the
accessory 340 is driven at an appropriate speed for the
complementary implant 330.
[0134] As part of this process, the control console 28 first
verifies that the accessory 340 is an appropriate type of accessory
for driving the implant. This verification may be performed by,
first, determining the type of implant from the data read from the
implant chip 336. Then, based on data contained in the memory
internal to the control console 28, the control console determines
if the accessory 340 can drive the implant. Alternatively, the data
in the implant chip 336 contains a list of the types of accessories
340 that are appropriate for driving the implant. If initially, the
control console 28, based on the determination of the type of
accessory and the type of implant, determines that the accessory is
inappropriate, the control console either provides a warning
message that the surgeon must acknowledge this fact or prevents
actuation of the handpiece 22b.
[0135] If the accessory 340 is an appropriate accessory for driving
the implant, control console 28 configures the system so that
energization signals are applied to the handpiece 22b that will
cause the accessory to be driven at the preferred speed. If the
surgeon attempts to drive the accessory above an appropriate
maximum speed for the implant 330 or the accessory 340, at a
minimum, the control console presents a warning the surgeon must
acknowledge before the procedure is allowed to proceed.
[0136] Control console 28 also forwards the data regarding the
characteristics of the implant 330 and the driving accessory 340 to
a surgical navigation unit 350. Prior to this part of the
procedure, the surgical navigation unit was provided with data that
describes the physical dimensions of the portion of the patient on
which the procedure is being performed. A tracker, not shown is
attached to the handpiece 22b. The surgical navigation unit 350
monitors the position of the tracker. When the surgical procedure
is being performed, the surgical navigation unit has the following
data: position of the tracker; data regarding the physical
characteristics of the handpiece 22a and accessory 340; and, from
the implant chip 336, data regarding the physical characteristics
of the implant 330. Based on these data and the stored image of the
patient, the surgical navigation unit 350 is able to determine the
position of the implant 330 as it is driven into the body of the
patient 332. This information is presented on a monitor 352.
[0137] Also, the surgical navigation unit 350 determines, based on
the stored data regarding the implant 330 and patient 332, if it
appears that there is a possibility that the implant is being
inappropriately positioned in the patient. For example, if the
implant is a screw that is supposed to only be driven into bone to
a certain depth, the surgical navigation unit monitors the extent
to which the implant is driven into the bone. If it appears that
continued driving of the implant into the bone is inappropriate,
the surgical navigation unit 350 causes a warning to be presented.
The surgical navigation unit 350 also inhibits the control console
28 for supplying energization signals to the handpiece 22b until
the warning is acknowledged.
[0138] Also, as mentioned above with respect to the data stored in
chip controller/memory 84, this component may contain data that
indicates the extent to which the cutting accessory is worn. One
means of determining cutting accessory wear is now described by
reference to FIG. 23. Specifically, controller 70, in addition to
monitoring the amount of time a cutting accessory is actuated
monitors the voltage applied to the handpiece that actuates the
cutting accessory as well as the current drawn by the handpiece,
step 370. When the handpiece motor is actuated, controller 70
performs step 372, a power consumed calculation for the handpiece.
In step 372, based on the voltage applied to the handpiece, the
current drawn and the time the handpiece was used, controller 70
determines the Watts minutes of power consumed by the
handpiece.
[0139] Then, once the handpiece motor is turned off, in step 374,
data representative of the power consumed by the handpiece is then
written by the controller 70 into the WEAR PROFILE data field 112
of controller memory 84.
[0140] It should be understood that the data in the WEAR PROFILE
data field 112 are used in the same generally manner as the data in
the TIME USED field 110 are used. Specifically, these data are read
by controller 70. During the use of the cutting accessory, in a
location within the memory integral with control console 28 data
representative of the cumulative watt minutes of power consumed in
actuating the cutting accessory are stored. These data are based on
the data read from the WEAR PROFILE field 112 as well as the data
generated as a result of the periodic execution of steps 370 and
372 when the handpiece motor is actuated. These data representative
of total cutting accessory wear are compared to a reference value.
This reference value may be from data read from chip 62, (data
storage field not shown) from the handpiece or a set value in the
control console memory 69. If this comparison indicates that the
total amount of power employed to drive the cutting accessory
exceeds the reference value, a warning message is generated on the
console display 71. This provides the surgeon with an indication
that the cutting accessory may be worn to a level that the
efficiency of the accessory has appreciably diminished.
[0141] FIG. 24 depicts in block diagram components internal to a
control console to which plural handpieces may be simultaneously
attached. Specifically, there is a first processor, main controller
380, and a second processor, accessory interrogator 382. The main
controller 380 is the processor that has primary responsibility for
generating the command signals to the drivers internal to the
control console that supply the energization signals to the
individual handpieces 22a, 22b and 22c, (drivers not shown). The
input signals into main controller 380 include the characteristics
of the individual handpieces as well as the surgeon-originating
command signals that indicate the rate at which the handpieces are
to be actuated.
[0142] The input signals into main controller 380 also include the
data read from the identification chips 62 integral with the
cutting accessories 24 attached to the individual handpiece 22a,
22b, and 22c. These data are retrieved by the accessory integrator
382. Once the accessory interrogator 382 retrieves these data, the
interrogator forwards these data to the main controller 380. The
main controller 380, in turn, generates command signals to the
drivers to cause each handpiece 22a, 22b and 22c to be actuated
appropriately for the attached cutting accessory 24.
[0143] FIG. 25 depicts one protocol for retrieving data from the
cutting accessory identification chips. Specifically, after the
main controller 380 determines that a handpiece 22a, 22b or 22c is
connected to one of the control console 28 connections, the main
controller instructs the accessory interrogator 382, to initiate an
interrogation sequence for that handpiece, (step not shown).
Initially, the interrogation sequence consists of accessory
interrogator 382 generating a request that any attached accessory
write back one specific type of data. This request, represented by
step 388, is performed so that the accessory interrogator 382 can
determine whether or not an accessory is even attached to the
handpiece 22a, 22b or 22c. The accessory interrogator 382 performs
this write request and waits for data step continually, as long as
there is an attached handpiece. In one version of the invention,
the specific data the accessory interrogator 382 requests is the
cutting accessory serial number.
[0144] Upon attachment of a cutting accessory 24 to a handpiece
22a, 22b or 22c, the identification chip in the accessory will, in
response to the write request, read out the serial number. Upon
receipt of these data, accessory interrogator requests that all the
data in the accessory identification chip 64 be written back. This
write request and the subsequent data write out, are represented by
step 390. In step 392 the identification chip data used to control
operation of the cutting accessory 24 are forwarded to the main
controller 380. The main controller, as discussed previously with
regard to step 126, configures the system so that energization
signals will be supplied to the handpiece 22a, 22b or 22c that will
cause the appropriate energization of the attached cutting
accessory 24.
[0145] After the data are read from the accessory identification
chip 62, the accessory interrogator 382 continually generates a
read request for the serial number of the accessory. This serial
number is continuously compared to the serial number originally
read for the cutting accessory. The read-request, data write and
comparison steps collectively represented as step 394. These steps
are performed in order to ensure that the same cutting accessory 24
remains attached to the handpiece 22a, 22b or 22c. As long as the
same cutting accessory is attached to the particular handpiece,
there is no change in the overall operation of the system.
[0146] If, however, the serial number is different, or no serial
number is returned, the accessory interrogator 382 interprets the
response indicating the accessory was removed or switched.
Accessory interrogator 382 then proceeds to step 396. In step 396,
the accessory interrogator generates a message to the main
controller 380 informing the main controller of the disconnect of
the cutting accessory. The main controller 380, in a step not
shown, then regulates the energization of the associated handpiece
as is appropriate for a cutting accessory not being attached. This
particular regulation may, for example, consist of the inhibiting
of the actuation of the handpiece.
[0147] The accessory interrogator 382 then reexecutes step 388.
Step 388 is again repetitively reexcuted until it receives a serial
number indicating a cutting accessory 24 has again been attached to
the handpiece.
[0148] An advantage of the above arrangement is that, the majority
of read requests generated by the accessory interrogator and
subsequent data writes by the accessory NOVRAMs 32 are for
relatively small amounts of data. This makes it possible for the
accessory interrogator to, in a relatively short amount of time,
monitor whether or not accessories 24 are attached to each of the
handpieces 22a, 22b and 22c. Thus, in the event there is a removal
or replacement of the cutting accessory attached to any one of the
handpiece 22a, 22b or 22c, the accessory interrogator will detect
this change, typically within 50 msec. or less of the event. Main
controller 380 is then promptly informed of this state change so as
to substantially eliminate the likelihood that a handpiece will be
actuated even though there is no attached accessory, or actuated in
an inappropriate manner for the attached handpiece.
[0149] An alternative protocol for reading data from a cutting
accessory identification chip 62 is now described by reference to
FIG. 26. Here an accessory present read-request and receive written
data step 402, identical to step 388, is performed as before
whenever a handpiece 22a, 22b or 22c is connected to a control
console 28. However, if the accessory interrogator 382 does not
provide the main controller 380 with a data from accessory
identification chip 62, in step 404, the main controller sets the
control console to energize the handpiece 22a, 22b or 22c based on
default setting for the handpiece. These settings are based on data
in the handpiece NOVRAM. Accessory interrogator 382 and main
controller 380 repetitively reexcute steps 402 and 404,
respectively, until data are returned by an accessory
identification chip 62.
[0150] Once data, again typically a serial number, are returned by
the identification chip 62 of a newly installed cutting accessory
24, the accessory interrogator requests all the data in the chip,
represented by step 406. These data are forwarded by the accessory
interrogator 382 to the main controller 380, step not illustrated.
Based on these data, in step 408, the main controller resets the
data used to control the handpiece so that the handpiece 22a, 22b
or 22c is energized appropriately for the attached cutting
accessory 24. As before, even when the handpiece 22a, 22b or 22c is
energized, the accessory interrogator 382 continues to request the
serial number information from the accessory identification chip 62
to determine whether or not it has changed, step 410.
[0151] If, in step 410, it is determined that there has been a
change in the cutting accessory 24 attached to the handpiece step
402 is again executed. Depending on the results of the inquiry
performed in step 402 either step 404 or step 406 is again
executed.
[0152] An advantage of this method of operation is that there may
be some handpieces that are used primarily with one particular type
of cutting accessory. The cutting accessory with which the
handpiece is most often used is not provided with an identification
chip. The handpiece NOVRAM 32 contains data setting the handpiece
to operate in accordance with the characteristics of this
particular cutting accessory. Thus, in this version of the
invention, the cost of providing the most often used cutting
accessory with an identification chip is eliminated.
[0153] A more detailed explanation of how the cutting accessory and
implant recognition system of this invention can be used in
combination with a surgical navigation unit 350 is now described by
reference to FIG. 27. Specifically, this invention can be used to
facilitate the placement of an implant in a patient. As represented
by step 420, initially the surgical navigation unit 350 is employed
to measure the portion of the body of the patient to which the
implant is to be fitted. Then, as represented by step 422, as part
of the procedure, the surgical navigation unit generates a message
prompting the surgeon to select an implant, or a particular
component of an implant, for fitting to the patient.
[0154] The surgeon then identifies the implant 330, as represented
by step 424. In this step, the surgeon identifies the specific
implant by placing the handpiece 22 or cutting accessory 24 in
close proximity to the implant so that the data in the implant chip
336 can be inductively written to the control console 28. In some
versions of the invention, a passive surgical instrument, like a
pointer with a built in coil, may be used to perform this data
read-request and receive the written out data.
[0155] The data identifying the implant are written to the surgical
navigation unit 350. The surgical navigation unit 350, in turn,
based on input variables such as the dimensions of the implant and
the measurements of the patient's body, determines whether or not
the implant is appropriate for the procedure being performed,
verify implant step 426. If, in step 426, the surgical navigation
unit 350 determines that the implant might be inappropriate for the
procedure, for example, the size appears inappropriate for the
position in the body in which it is to be placed, the surgical
navigation unit generates a warning to the surgeon, step not
shown.
[0156] The next step in the procedure is the prompting by the
surgical navigation unit 350 of the accessory that is to be used to
fit the implant, step 428. The surgical navigation unit, in step
430, verifies that the accessory is the appropriate accessory for
driving the implant. If an inappropriate accessory is selected, an
appropriate warning is presented, warning step not shown.
[0157] In step 432 the surgical navigation unit 350 determines
whether or not the accessory and implant are ready for the fitting
of the implant. This step is performed by determine whether or not
the signal transferred to the accessory coil 342 indicates the
implant 330 is fitted to the accessory. Once the accessory and
implant are ready for implant installation, the surgical navigation
unit, in step 434, presents on monitor 352 information about the
exact surgical sub procedure that is performed to fit the implant.
This information may include an image of the site where the implant
is to be fitted. This information may also include textual
commentary regarding aspects of the procedure.
[0158] Thus, the integrated system of this invention provides
guidance and prompts to the surgeon to facilitate the execution of
the surgical procedure. This can minimize the time the patient is
held under anesthesia which is one of the goals of modern surgery.
Also, the implant and accessory verification steps serve to reduce
the likelihood that an inadvertent oversight causes a surgeon to
attempt to use a less than optimal component during a surgical
procedure.
[0159] The cutting accessory and implant recognition system of this
invention is also used to assist in the inventory of components
used during a surgical procedure. As seen by reference to FIG. 28,
components 440a, 440b, . . . 440f used to perform the procedure are
kept in a case 442. For example, certain instruments may be held in
a sterilization case. Alternatively trial implant components are
held in a trial case.
[0160] As part of the procedure, the control console 28, in step
444, determines when a component is used. This determination occurs
when an accessory is fitted to a handpiece or another device, for
example an implant or an implant trial unit, is fitted in place
with the handpiece or cutting accessory. As discussed above, the
data in the chip integral with this instrument or implant is
inductively read.
[0161] As a consequence of this component used determination, a
local inventory of used components is updated, step 446. A database
in which these information is stored, a local inventory database
480, is connected to the control console as discussed below with
respect to FIG. 30. Data are written to and read from this database
480 by a dedicated processor, not shown.
[0162] Eventually, there is a point in the procedure in which it is
time to inventory the used components to ensure that their
whereabouts are known and they are properly stored. Typically this
point is near the end of the procedure. At this time, the processor
associated with the local inventory database 480 identifies a
component that needs for which accounting is required, step 448.
The identity of this component is sent to either the control
console 28 or the surgical navigation unit 350. The device that
receives this information, in step 450, requests the surgical
personnel to locate this component. In response to this request,
also part of step 450 in FIG. 29, the personnel return the
component 440a, 440b . . . or 440f to the case 442 in which the
component is stored and inductively read the stored identifying
information for the component.
[0163] Data indicating that the component has been properly
returned to the case 442 are forwarded to the processor associated
with the local inventory database 480. This processor, in step 452,
updates the inventory for the particular case 442. The local
inventory database processor then reexecutes step 448. If there are
still missing components, step 450 is reexcuted and one of the
remaining missing components is again identified. However, in step
448 it may be determined that all the components are accounted for.
If the local inventory database processor makes this determination,
this processor causes the control console 28 or navigation unit 350
to display a message indicating that the inventory is complete,
step 454.
[0164] The above aspect of this invention facilitates the checking
of equipment used during surgery to ensure the whereabouts of this
equipment is known.
[0165] As mentioned above, and now described by reference to FIG.
30, the information generated by the accessory and implant
recognition system of this invention may be employed by components
other than the control console that drive the handpieces used to
actuate the accessories. Specifically, as seen in this Figure, the
control console that reads the accessory and implant identify data
may be attached to a local area network to which other equipment
both in the operating room and elsewhere in the medical facility
are attached. In one version of a network it is contemplated that
this data transfer be over a serial bus in accordance with the
IEEE-1394 data transfer protocol.
[0166] Three devices attached this network are the control console
28, the surgical navigation unit 350 and the local inventory
database 480.
[0167] The facility's billing processor, represented by node 482 is
also attached to this network. The billing processor receives data
packets identifying the patient-chargeable components identified by
the control console that are used during the procedure. This
facilitates the accurate charging of the patient for the equipment
used during the surgical procedure.
[0168] The records of components used are also forwarded to
facility's primary inventory control database, node 484. This
allows the processor that monitors inventory levels of the
accessories and implants to determine when the additional equipment
needs to be shipped, represented by supplier ship node 486. Also,
some suppliers only bill the facility when the equipment is
actually used. The inventory control database, upon receiving an
indication that some equipment has been used, through a supplier
bill node 488 informs the supplier's processor of this event. This
arrangement thus makes it possible to ensure that a facility is
only billed for equipment when the equipment is used.
[0169] Also the database in the facility that maintains patient
records, represented by node 490, receives an indication of the
cutting accessories, trial components, and implants fitted during
the surgical procedure. Thus, medical personnel do not, during the
procedure have to spend time documenting what specific components
where used during the procedure. Since the use of these components
can readily be data stamped, the personnel likewise do not have to
document when these components were used.
[0170] Also, there is no reason that in all versions of the
invention the tags be inductively coupled to the complementary
handpieces in which their accessories are inserted. In some
versions of the invention, there may be physical connections
between the exposed contacts that are part of the handpiece and
accessory. These contacts, upon physical abutment, establish the
connection between the accessory tag and the conductors in the
handpiece that extend to the control console.
[0171] Furthermore, in some versions of the invention, the coil
that inductively couples the signal to the cutting accessory may
not be in the handpiece. In some versions of the invention, this
coil may be located in the control console. Whenever a new cutting
accessory is attached to the handpiece, information about this
event is sensed by a device internal to the handpiece and a signal
representative of this event is forwarded to the control console.
The control console then generates a message directing the surgeon
to place the handpiece and cutting accessory sub-assembly adjacent
a particular location on the control console to facilitate the
inductive transfer of signals between the console and the accessory
tag. An advantage of this version of the invention is that it
eliminates the need to provide additional conductors in the cable
that extends to the handpiece.
[0172] Another embodiment of the invention is shown in FIG. 31. In
this embodiment, no cable connects the handpiece or cordless
powered surgical tool to a control console. The Applicant's
Assignee's U.S. patent application, CORDLESS, POWERED SURGICAL TOOL
Ser. No. 10/210,325, filed on Aug. 1, 2002, now U.S. Pat. No.
6,960,894 B2, and incorporated herein by reference, provides
details of a physical structure of a cordless powered surgical
tool. Likewise Applicant's Assignee's U.S. Pat. No. 5,747,953
entitled CORDLESS, BATTERY OPERATED SURGICAL TOOL, issued May 5,
1998, and incorporated herein by reference, describes a surgical
tool that may be modified to include the circuit arrangement shown
in FIG. 31.
[0173] As shown in FIG. 31, the cutting or operating end of the
cordless surgical tool 522 is provided with an annular coil 566.
Collectively, the cordless surgical tool 522 and cutting accessory
524 are shaped so that coils 564 and 566 are in such proximity to
each other that they will collectively inductively transfer signals
from/to the circuit internal to the surgical tool 522 to/from the
circuit internal to the identification chip 562. Typically, the
housing of the surgical tool 522 is formed of materials discussed
in Applicant's above patent documents.
[0174] The surgical tool 522 includes a battery 590 that supplies
power, as necessary, to the circuit elements therein (connections
not shown). A controller 570 controls the overall operation of the
system. Memory 569 in the surgical tool 522 contains the permanent
operating instructions that are executed by controller 570 to
control the system and regulate the actuation of the surgical tool
522 and the cutting accessory 524. Controller 570 generates
energization control signals to a driver 572. The energization
control signals are based on the cutting accessory 524 identified
and the value selected by a manual actuator device 549. The manual
actuator device 549 can be a trigger type push button controlling
the output from a variable resistor or any other type of device
providing a variable signal output. The driver 572, based on the
value of the output from the manual actuator device 549 and the
cutting accessory 524 identified, generates the energization
signals that are applied to the surgical tool motor 526.
[0175] The surgical tool 522 can also include a touch screen
display 571 or other type of indicator/input system. Controller 570
causes information regarding the state of the system to be
presented on the display 571. Controller 570 can also cause images
of buttons to be presented on the display 571. An operator
regulates the operation of the system by selectively depressing
these buttons. In other embodiments, no indicator or display is
present. The system automatically controls the cutting accessory
524 based on the accessory identified. For example, the maximum
operating speed of the cutting accessory 524 can be varied
depending of the accessory identified.
[0176] The surgical tool 522 also includes a modulator (MOD) 574
that modulates digital signals output by controller 570 so they can
be inductively transferred to cutting accessory identification chip
562. In one preferred version of the invention, modulator 574
receives a fixed-frequency signal from an oscillator 576 internal
to the surgical tool 522.
[0177] Modulator 574 produces an amplitude shift keyed signal
generated by modulator 574 that is amplified by an amplifier 578.
The output signal from amplifier 578 is applied to one end of coil
566.
[0178] Demodulator 580 receives a signal that is coupled to coil
566, demodulates the signal, and applies the output bit stream to
controller 570.
[0179] The identification chip 562 can include a small controller
and an electronically programmable memory (.mu.C & MEM) 584.
The controller integral with controller/memory 584 controls the
writing of data into its complementary memory section and the
reading out of the contents of the memory. Modulator/demodulator
(MOD DEM) 586, clock 588, capacitor 583 and power regulator 589
function in substantially the same manner as described for the
embodiment in FIG. 3.
[0180] In FIG. 31, coil 564 is shown as being integrally part of
chip 562. This is one option for the invention. However, as
discussed above, it is anticipated that in many versions of the
invention, chip 62 and coil 564 will be separate components.
[0181] Some of the different types of data stored in the tag
controller/memory 584 include a serial number specific to the
cutting accessory 524 with which tag 562 is integral. This number
may also include a special authorization code. There is also stored
data that indicates the type of cutting accessory 524. For example,
the cutting accessory 524 may be a drill, saw, burr, linkage
assembly for converting rotary movement to a back-and-forth
movement, or other types of elements. In cases where a linkage
assembly is utilized, an identification tag may be provided on the
linkage assembly as well as a cutting element secured to the
linkage assembly. The linkage assembly can function as an
intermediate attachment between the surgical tool 522 and the
cutting accessory 524 in a manner similar to the arrangement shown
in FIG. 20.
[0182] The stored data can include the size, diameter, physical
materials, and type of cutting accessory 524. The data can also
include the preferred operating speed, maximum operating speed,
maximum operating torque, stopping torque, or other type of
information regarding operation of the cutting accessory 524. The
mode of operation of the cutting accessory 524, such as oscillatory
or unidirectional can also be provided with the data.
[0183] Data indicating if and when the cutting accessory 524 was
previously used, and for how long can be read and written to the
chip 562. Data indicating how long a surgeon can expect to use the
cutting accessory 524 before the cutting/drilling surfaces become
worn to the level at which they may not efficiently cut tissue can
be read/stored.
[0184] The cordless surgical tool 522 of FIG. 31 operates in a
similar manner to the handpieces connected by cables 30 in
embodiments discussed above.
[0185] In another embodiment, the accessory 524 comprises an
implant device, such as a screw or other element that is directly
implanted into the body of a patient using the surgical tool 522.
In this instance, the characteristics of the accessory element are
provided to the surgical tool 522 regarding desired torque,
operating speed, etc. for implanting the implant device.
[0186] Therefore, it is an object of the appended claims to cover
all such variations and modifications that come within the true
spirit and scope of this invention.
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