U.S. patent application number 13/426792 was filed with the patent office on 2013-09-26 for surgical instrument usage data management.
The applicant listed for this patent is Stephen J. Balek, William E. Clem, Cory G. Kimball, Michael R. Lamping, Amy L. Marcotte, Daniel W. Price, John B. Schulte, Danius P. Silkaitis. Invention is credited to Stephen J. Balek, William E. Clem, Cory G. Kimball, Michael R. Lamping, Amy L. Marcotte, Daniel W. Price, John B. Schulte, Danius P. Silkaitis.
Application Number | 20130253480 13/426792 |
Document ID | / |
Family ID | 47915523 |
Filed Date | 2013-09-26 |
United States Patent
Application |
20130253480 |
Kind Code |
A1 |
Kimball; Cory G. ; et
al. |
September 26, 2013 |
SURGICAL INSTRUMENT USAGE DATA MANAGEMENT
Abstract
A surgical instrument operable to sever tissue includes a body
assembly and a selectively coupleable end effector assembly. The
end effector assembly may include a transmission assembly and an
end effector. The body assembly includes a trigger and a casing
configured to couple with the transmission assembly. An information
transmission system transmits instrument information received from
a sensor, for example, to a secure server via a secure gateway
connected to the instrument. The instrument may be previously
tested on a calibration kit to pre-determine and load
surgeon-specific settings onto the instrument prior to use.
Inventors: |
Kimball; Cory G.;
(Cincinnati, OH) ; Price; Daniel W.; (Loveland,
OH) ; Clem; William E.; (Bozeman, MT) ;
Marcotte; Amy L.; (Mason, OH) ; Silkaitis; Danius
P.; (Seattle, WA) ; Schulte; John B.; (West
Chester, OH) ; Lamping; Michael R.; (Cincinnati,
OH) ; Balek; Stephen J.; (Springboro, OH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Kimball; Cory G.
Price; Daniel W.
Clem; William E.
Marcotte; Amy L.
Silkaitis; Danius P.
Schulte; John B.
Lamping; Michael R.
Balek; Stephen J. |
Cincinnati
Loveland
Bozeman
Mason
Seattle
West Chester
Cincinnati
Springboro |
OH
OH
MT
OH
WA
OH
OH
OH |
US
US
US
US
US
US
US
US |
|
|
Family ID: |
47915523 |
Appl. No.: |
13/426792 |
Filed: |
March 22, 2012 |
Current U.S.
Class: |
606/1 |
Current CPC
Class: |
A61B 2017/00017
20130101; A61B 17/320092 20130101; A61B 2017/320093 20170801; H04L
67/32 20130101; A61B 17/28 20130101; A61B 90/98 20160201; G06Q
20/085 20130101; A61B 2017/320094 20170801; A61B 2017/0046
20130101; A61B 2017/320095 20170801; A61B 2018/0063 20130101; A61B
2018/00988 20130101; A61B 2017/00464 20130101; G16H 20/40 20180101;
A61B 2017/00026 20130101; A61B 2017/2931 20130101; A61B 2017/00725
20130101; A61B 2090/0804 20160201; A61B 2017/320097 20170801; A61B
18/1445 20130101; A61B 2090/0807 20160201; A61B 2017/00221
20130101; A61B 90/90 20160201; A61B 2017/00477 20130101; A61B
2090/0803 20160201; G16H 40/63 20180101 |
Class at
Publication: |
606/1 |
International
Class: |
A61B 17/00 20060101
A61B017/00 |
Claims
1. A surgical instrument system comprising: (a) a surgical
instrument comprising: (i) a body operable to communicate with
different kinds of end effector assemblies, (ii) a modular end
effector assembly removably coupled with the body, (iii) a power
source operable to drive the end effector, and (iv) a sensor,
wherein the sensor is configured to transmit information associated
with the end effector; and (b) a storage device operable to receive
data from the at least one of the sensor or the power source.
2. The surgical instrument of claim 1, wherein the power source
comprises a generator, wherein the generator is configured to
transmit information to the storage device.
3. The surgical instrument of claim 2, wherein the sensor is
configured to receive power from the generator, wherein upon
receipt of the power, the sensor is configured to transmit
information to the generator.
4. The surgical instrument of claim 2, wherein the storage device
comprises a gateway and a server, and wherein the gateway is
configured to initiate a call for a secure key to the server.
5. The surgical instrument of claim 4, wherein the server is
configured to reply to the gateway with the secure key.
6. The surgical instrument of claim 5, wherein the gateway is
configured to validate the secure key.
7. The surgical instrument of claim 5, wherein the gateway is
configured to initiate an upload of information to the server.
8. The surgical instrument of claim 7, wherein the server is
configured to transmit the uploaded information to a patient
file.
9. The surgical instrument of claim 8, wherein the uploaded
information comprises at least one of end effector assembly
oscillation data or end effector assembly usage time data.
10. The surgical instrument of claim 9, wherein the patient file
comprises a software application, wherein the software application
is configured to calculate a cost based on at least one of end
effector assembly oscillation data or end effector assembly time
usage data.
11. The surgical instrument of claim 10, wherein the server is
configured to transmit the cost to one or more manufacturers or
vendors of at least one of the body or the end effector
assembly.
12. The surgical instrument of claim 10, wherein the software
application is configured to analyze uploaded information from one
or more patient files to generate a report on a surgeon-specific
usage of at least one of the body or one or more end effector
assemblies.
13. The surgical instrument of claim 1, wherein the sensor
comprises an accelerometer.
14. The surgical instrument of claim 1, wherein the storage device
comprises a secure server outside a hospital network.
15. The surgical instrument of claim 1, wherein the power source is
configured to receive one or more serial numbers of at least one of
the sensor, the body, or the end effector assembly.
16. A method for uploading information from a generator in
communication with a surgical instrument, the surgical instrument
including a detachable transmission assembly extending distally
from a body, wherein an end effector is disposed at a distal end of
the transmission assembly, wherein the method comprises the steps
of: (a) capturing data via a sensor disposed in at least one of the
detachable transmission assembly, the end effector, or the body of
the surgical instrument when the instrument is used or after the
instrument is used in a procedure on a first patient; (b) uploading
data from the sensor, via a processor, to a secure gateway; (c)
initiating a secure key validation; and (d) based on the secure key
validation, transmitting the uploaded data via the processor to a
secure server.
17. The method of claim 16, further comprising: (a) uploading into
the generator one or more unique serial numbers associated with at
least one of the detachable transmission assembly, the end
effector, or the body of the surgical instrument; (b) transmitting
the uploaded data from the secure server to a patient file of the
first patient; and (c) displaying the information, via the
processor, on a display screen.
18. The method of claim 17, wherein the step of transmitting the
uploaded data to a patient file comprises transmitting uploaded
data comprising at least one of end effector oscillation data or
end effector time usage data, further comprising. (a) calculating a
cost based on at least one of end effector oscillation data or end
effector time usage data; (b) displaying the cost, via the
processor, on the display screen; and (b) transmitting the cost to
one or more manufacturers or vendors of at least one of the body,
the detachable transmission assembly, or the end effector.
19. The method of claim 17, further comprising analyzing uploaded
data from one or more patient files to generate a report on a
surgeon-specific usage of at least one of at least one of the body,
one or more detachable transmission assemblies, or one or more end
effectors.
20. A method for storing calibrated settings on a surgical
instrument in communication with a generator, the surgical
instrument including a selected detachable transmission assembly
extending distally from a body, wherein a selected end effector is
disposed at a distal end of the transmission assembly, wherein the
method comprises the steps of: (a) coupling an end effector
assembly with the instrument body to provide a first assembled
surgical instrument; (b) using the first assembled surgical
instrument on material of a calibration kit while the generator is
in a calibration mode, wherein the generator is operable to select
or establish a calibrated use setting based on the act of using the
first assembled surgical instrument of the calibration kit; (c)
de-coupling the end effector assembly from the instrument body; (d)
coupling another end effector assembly with the instrument body to
provide a second assembled surgical instrument; and (e) using the
second assembled surgical instrument in a surgical procedure,
wherein the generator is operable to drive the end effector in
accordance with the established calibrated use settings.
Description
BACKGROUND
[0001] In some settings, endoscopic surgical instruments may be
preferred over traditional open surgical devices since a smaller
incision may reduce the post-operative recovery time and
complications. Consequently, some endoscopic surgical instruments
may be suitable for placement of a distal end effector at a desired
surgical site through a cannula of a trocar. These distal end
effectors may engage tissue in a number of ways to achieve a
diagnostic or therapeutic effect (e.g., endocutter, grasper,
cutter, stapler, clip applier, access device, drug/gene therapy
delivery device, and energy delivery device using ultrasound, RF,
laser, etc.). Endoscopic surgical instruments may include a shaft
between the end effector and a handle portion, which is manipulated
by the clinician. Such a shaft may enable insertion to a desired
depth and rotation about the longitudinal axis of the shaft,
thereby facilitating positioning of the end effector within the
patient.
[0002] Examples of endoscopic surgical instruments include those
disclosed in U.S. Pat. No. 7,416,101 entitled "Motor-Driven
Surgical Cutting and Fastening Instrument with Loading Force
Feedback," issued Aug. 26, 2008, the disclosure of which is
incorporated by reference herein; U.S. Pat. No. 7,738,971 entitled
"Post-Sterilization Programming of Surgical Instruments," issued
Jun. 15, 2010, the disclosure of which is incorporated by reference
herein; U.S. Pub. No. 2006/0079874 entitled "Tissue Pad for Use
with an Ultrasonic Surgical Instrument," published Apr. 13, 2006,
the disclosure of which is incorporated by reference herein; U.S.
Pub. No. 2007/0191713 entitled "Ultrasonic Device for Cutting and
Coagulating," published Aug. 16, 2007, the disclosure of which is
incorporated by reference herein; U.S. Pub. No. 2007/0282333
entitled "Ultrasonic Waveguide and Blade," published Dec. 6, 2007,
the disclosure of which is incorporated by reference herein; U.S.
Pub. No. 2008/0200940 entitled "Ultrasonic Device for Cutting and
Coagulating," published Aug. 21, 2008, the disclosure of which is
incorporated by reference herein; U.S. Pat. Pub. No. 2009/0143797,
entitled "Cordless Hand-held Ultrasonic Cautery Cutting Device,"
published Jun. 4, 2009, the disclosure of which is incorporated by
reference herein; U.S. Pub. No. 2009/0209990 entitled "Motorized
Surgical Cutting and Fastening Instrument Having Handle Based Power
Source," published Aug. 20, 2009, the disclosure of which is
incorporated by reference herein; U.S. Pub. No. 2010/0069940
entitled "Ultrasonic Device for Fingertip Control," published Mar.
18, 2010, the disclosure of which is incorporated by reference
herein; and U.S. Pub. No. 2011/0015660, entitled "Rotating
Transducer Mount for Ultrasonic Surgical Instruments," published
Jan. 20, 2011, the disclosure of which is incorporated by reference
herein. Similarly, various ways in which medical devices may be
adapted to include a portable power source are disclosed in U.S.
Provisional Application Ser. No. 61/410,603, filed Nov. 5, 2010,
entitled "Energy-Based Surgical Instruments," the disclosure of
which is incorporated by reference herein.
[0003] Additional examples endoscopic surgical instruments include
are disclosed in U.S. Pat. No. 6,500,176 entitled "Electrosurgical
Systems and Techniques for Sealing Tissue," issued Dec. 31, 2002,
the disclosure of which is incorporated by reference herein; U.S.
Pat. No. 7,112,201 entitled "Electrosurgical Instrument and Method
of Use," issued Sep. 26, 2006, the disclosure of which is
incorporated by reference herein; U.S. Pat. No. 7,125,409, entitled
"Electrosurgical Working End for Controlled Energy Delivery,"
issued Oct. 24, 2006, the disclosure of which is incorporated by
reference herein; U.S. Pat. No. 7,169,146 entitled "Electrosurgical
Probe and Method of Use," issued Jan. 30, 2007, the disclosure of
which is incorporated by reference herein; U.S. Pat. No. 7,186,253,
entitled "Electrosurgical Jaw Structure for Controlled Energy
Delivery," issued Mar. 6, 2007, the disclosure of which is
incorporated by reference herein; U.S. Pat. No. 7,189,233, entitled
"Electrosurgical Instrument," issued Mar. 13, 2007, the disclosure
of which is incorporated by reference herein; U.S. Pat. No.
7,220,951, entitled "Surgical Sealing Surfaces and Methods of Use,"
issued May 22, 2007, the disclosure of which is incorporated by
reference herein; U.S. Pat. No. 7,309,849, entitled "Polymer
Compositions Exhibiting a PTC Property and Methods of Fabrication,"
issued Dec. 18, 2007, the disclosure of which is incorporated by
reference herein; U.S. Pat. No. 7,311,709, entitled
"Electrosurgical Instrument and Method of Use," issued Dec. 25,
2007, the disclosure of which is incorporated by reference herein;
U.S. Pat. No. 7,354,440, entitled "Electrosurgical Instrument and
Method of Use," issued Apr. 8, 2008, the disclosure of which is
incorporated by reference herein; U.S. Pat. No. 7,381,209, entitled
"Electrosurgical Instrument," issued Jun. 3, 2008, the disclosure
of which is incorporated by reference herein; U.S. Pub. No.
2011/0087218, entitled "Surgical Instrument Comprising First and
Second Drive Systems Actuatable by a Common Trigger Mechanism,"
published Apr. 14, 2011, the disclosure of which is incorporated by
reference herein; U.S. patent application Ser. No. 13/151,181,
entitled "Motor Driven Electrosurgical Device with Mechanical and
Electrical Feedback," filed Jun. 2, 2011, the disclosure of which
is incorporated by reference herein; U.S. patent application Ser.
No. 13/269,870, entitled "Surgical Instrument with Modular Shaft
and End Effector," filed Oct. 10, 2011, the disclosure of which is
incorporated by reference herein; U.S. patent application Ser. No.
13/235,660, entitled "Articulation Joint Features for Articulating
Surgical Device," filed Sep. 19, 2011, the disclosure of which is
incorporated by reference herein; U.S. patent application Ser. No.
13/274,805, entitled "Surgical Instrument with Modular End
Effector," filed Oct. 17, 2011, the disclosure of which is
incorporated by reference herein; U.S. patent application Ser. No.
13/276,725, entitled "Medical Device Usage Data Processing," filed
Oct. 19, 2011, the disclosure of which is incorporated by reference
herein; and U.S. patent application Ser. No. 13/276,660, entitled
"User Feedback Through Handpiece of Surgical Instrument," filed
Oct. 19, 2011, the disclosure of which is incorporated by reference
herein.
[0004] In addition, the surgical instruments may be used, or
adapted for use, in robotic-assisted surgery settings such as that
disclosed in U.S. Pat. No. 6,783,524, entitled "Robotic Surgical
Tool with Ultrasound Cauterizing and Cutting Instrument," issued
Aug. 31, 2004.
[0005] While several systems and methods have been made and used
for surgical instruments, it is believed that no one prior to the
inventors has made or used the invention described in the appended
claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] While the specification concludes with claims which
particularly point out and distinctly claim this technology, it is
believed this technology will be better understood from the
following description of certain examples taken in conjunction with
the accompanying drawings, in which like reference numerals
identify the same elements and in which:
[0007] FIG. 1 depicts a schematic view of an exemplary surgical
system comprising a medical device having a power source and a
cartridge;
[0008] FIG. 2 depicts a perspective view of an exemplary ultrasonic
surgical system comprising a surgical instrument and a
generator;
[0009] FIG. 3A depicts a perspective view another exemplary
surgical system comprising a surgical instrument with a transducer
removed and a detachable end effector;
[0010] FIG. 3B depicts a perspective view of the surgical
instrument of FIG. 3A with the transducer attached and the
detachable end effector attached;
[0011] FIG. 4 depicts a side elevation view of an exemplary
electrosurgical medical device;
[0012] FIG. 5 depicts a perspective view of the end effector of the
device of FIG. 3, in an open configuration;
[0013] FIG. 6A depicts a side elevation view of a first exemplary
coupling mechanism with a portion of a handle assembly in
cross-section to show the interior thereof and showing a decoupled
end effector assembly;
[0014] FIG. 6B depicts a side elevation view of the coupling
mechanism of FIG. 8A showing the end effector assembly coupled to
the handle assembly;
[0015] FIG. 7 depicts a schematic view of an exemplary information
transmission system;
[0016] FIG. 8A depicts a first portion of a flowchart showing an
exemplary use of the information transmission system of FIG. 7;
[0017] FIG. 8B depicts a second, continued portion of a flowchart
showing an exemplary use of the information transmission system of
FIG. 7;
[0018] FIG. 9 depicts a graphical view of data transmitted from an
exemplary sensor of an exemplary medical device;
[0019] FIG. 10 depicts a first graphical view of electrical
characteristics associated with a generator and a medical device
during a procedure;
[0020] FIG. 11 depicts a second graphical view of electrical
characteristics associated with a generator and a medical device
during a procedure;
[0021] FIG. 12 depicts a third graphical view of electrical
characteristics associated with a generator and a medical device
during a procedure;
[0022] FIG. 13A depicts a first portion of a flowchart showing an
exemplary use of an exemplary calibration kit with a medical
device; and
[0023] FIG. 13B depicts a second, continued portion of a flowchart
showing an exemplary use of an exemplary calibration kit with a
medical device.
[0024] The drawings are not intended to be limiting in any way, and
it is contemplated that various embodiments of the technology may
be carried out in a variety of other ways, including those not
necessarily depicted in the drawings. The accompanying drawings
incorporated in and forming a part of the specification illustrate
several aspects of the present technology, and together with the
description serve to explain the principles of the technology; it
being understood, however, that this technology is not limited to
the precise arrangements shown.
DETAILED DESCRIPTION
[0025] The following description of certain examples of the
technology should not be used to limit its scope. Other examples,
features, aspects, embodiments, and advantages of the technology
will become apparent to those skilled in the art from the following
description, which is by way of illustration, one of the best modes
contemplated for carrying out the technology. As will be realized,
the technology described herein is capable of other different and
obvious aspects, all without departing from the technology.
Accordingly, the drawings and descriptions should be regarded as
illustrative in nature and not restrictive.
[0026] It should be understood that the teachings below may be
readily applied to any of the references that are cited herein.
Various suitable ways in which the below teachings may be combined
with the references cited herein will be apparent to those of
ordinary skill in the art.
[0027] It is further understood that any one or more of the
teachings, expressions, embodiments, examples, etc. described
herein may be combined with any one or more of the other teachings,
expressions, embodiments, examples, etc. that are described herein.
The following-described teachings, expressions, embodiments,
examples, etc. should therefore not be viewed in isolation relative
to each other. Various suitable ways in which the teachings herein
may be combined will be readily apparent to those of ordinary skill
in the art in view of the teachings herein. Such modifications and
variations are intended to be included within the scope of the
claims.
[0028] I. Overview of Exemplary Surgical Instrument
[0029] FIG. 1 shows components of an exemplary medical device (10)
in diagrammatic block form. As shown, medical device (10) comprises
a control module (12), a power source (14), and an end effector
(16). Merely exemplary power sources (14) may include NiMH
batteries, Li-ion batteries (e.g., prismatic cell type lithium ion
batteries, etc.), Ni-Cad batteries, or any other type of power
source as may be apparent to one of ordinary skill in the art in
light of the teachings herein. Control module (12) may comprise a
microprocessor, an application specific integrated circuit (ASIC),
memory, a printed circuit board (PCB), a storage device (such as a
solid state drive or hard disk), firmware, software, or any other
suitable control module components as will be apparent to one of
ordinary skill in the art in light of the teachings herein. Control
module (12) and power source (14) are coupled by an electrical
connection (22), such as a cable and/or traces in a circuit board,
etc., to transfer power from power source (14) to control module
(12). Alternatively, power source (14) may be selectively coupled
to control module (12). This allows power source (14) to be
detached and removed from medical device (10), which may further
allow power source (14) to be readily recharged or reclaimed for
resterilization and reuse, such as in accordance with the various
teachings herein. In addition or in the alternative, control module
(12) may be removed for servicing, testing, replacement, or any
other purpose as will be apparent to one of ordinary skill in the
art in view of the teachings herein.
[0030] End effector (16) is coupled to control module (12) by
another electrical connection (22). End effector (16) is configured
to perform a desired function of medical device (10). By way of
example only, such function may include cauterizing tissue,
ablating tissue, severing tissue, ultrasonically vibrating,
stapling tissue, or any other desired task for medical device (10).
End effector (16) may thus include an active feature such as an
ultrasonic blade, a pair of clamping jaws, a sharp knife, a staple
driving assembly, a monopolar RF electrode, a pair of bipolar RF
electrodes, a thermal heating element, and/or various other
components. End effector (16) may also be removable from medical
device (10) for servicing, testing, replacement, or any other
purpose as will be apparent to one of ordinary skill in the art in
view of the teachings herein and as described with respect to FIGS.
3A-3B below. In some versions, end effector (16) is modular such
that medical device (10) may be used with different kinds of end
effectors (e.g., as taught in U.S. Provisional Application Ser. No.
61/410,603, etc.). Various other configurations of end effector
(16) may be provided for a variety of different functions depending
upon the purpose of medical device (10) as will be apparent to
those of ordinary skill in the art in view of the teachings herein.
Similarly, other types of components of a medical device (10) that
may receive power from power source (14) will be apparent to those
of ordinary skill in the art in view of the teachings herein.
[0031] Medical device (10) of the present example includes a
trigger (18) and a sensor (20), though it should be understood that
such components are merely optional. Trigger (18) is coupled to
control module (12) and power source (14) by electrical connection
(22). Trigger (18) may be configured to selectively provide power
from power source (14) to end effector (16) (and/or to some other
component of medical device (10)) to activate medical device (10)
when performing a procedure. Sensor (20) is also coupled to control
module (12) by an electrical connection (22) and may be configured
to provide a variety of information to control module (12) during a
procedure. By way of example only, such configurations may include
sensing impedance in tissue at end effector (16), sensing a
temperature at end effector (16), determining movement and/or
orientation of end effector (16), or determining the oscillation
rate of end effector (16). Data from sensor (20) may be processed
by control module (12) to effect the delivery of power to end
effector (16) (e.g., in a feedback loop, etc.). Various other
configurations of sensor (20) may be provided depending upon the
purpose of medical device (10) as will be apparent to those of
ordinary skill in the art in view of the teachings herein. Of
course, as with other components described herein, medical device
(10) may have more than one sensor (20), or sensor (20) may simply
be omitted if desired. Sensor (20) of medical device (10) may be
operable in accordance with the teachings of U.S. patent
application Ser. No. 13/276,725, the disclosure of which is
incorporated by reference herein.
[0032] In some versions, a cartridge (26) and generator (28) are
attached to medical device (10) via cable (30). For instance,
generator (28) may serve as a substitute for power source (14).
While medical device (10) is shown as being in communication with
both cartridge (26) and generator (28) via cables (30), it should
be understood that medical device (10) may alternatively
communicate with one or both of cartridge (26) and generator (28)
via a wireless communication.
[0033] II. Overview of Exemplary Ultrasonic Surgical System
[0034] FIG. 2 depicts a merely exemplary form that medical device
(10) may take. FIG. 2 shows an exemplary ultrasonic surgical system
(24) comprising an ultrasonic surgical instrument (50), a cartridge
(26), a generator (28), and a cable (30) operable to couple
generator (28) to surgical instrument (50). A suitable generator
(28) is the GEN 300 sold by Ethicon Endo-Surgery, Inc. of
Cincinnati, Ohio. By way of example only, generator (28) may be
constructed in accordance with the teachings of U.S. Pub. No.
2011/0087212, entitled "Surgical Generator for Ultrasonic and
Electrosurgical Devices," published Apr. 14, 2011, and U.S. patent
application Ser. No. 13/269,870, entitled "Surgical Instrument with
Modular Shaft and End Effector," filed Oct. 10, 2011, the
disclosures of which are incorporated by reference herein. It
should be noted that surgical instrument (50) will be described in
reference to an ultrasonic surgical instrument; however, the
technology described below may be used with a variety of surgical
instruments, including, but not limited to, endocutters, graspers,
cutters, staplers, clip appliers, access devices, drug/gene therapy
delivery devices, and energy delivery devices using ultrasound, RF,
laser, etc., and/or any combination thereof as will be apparent to
one of ordinary skill in the art in view of the teachings herein.
Moreover, while the present example will be described in reference
to a cable-connected surgical instrument (50), it should be
understood that surgical instrument (50) may be adapted for
cordless operation, such as that disclosed in U.S. Pat. Pub. No.
2009/0143797, entitled "Cordless Hand-held Ultrasonic Cautery
Cutting Device," published Jun. 4, 2009, the disclosure of which is
incorporated by reference herein. Furthermore, surgical device (50)
may also be used, or adapted for use, in robotic-assisted surgery
settings such as that disclosed in U.S. Pat. No. 6,783,524,
entitled "Robotic Surgical Tool with Ultrasound Cauterizing and
Cutting Instrument," issued Aug. 31, 2004.
[0035] Surgical instrument (50) of the present example includes a
multi-piece handle assembly (60), an elongated transmission
assembly (70), and a transducer (100). Transmission assembly (70)
is coupled to multi-piece handle assembly (60) at a proximal end of
transmission assembly (70) and extends distally from multi-piece
handle assembly (60). In the present example transmission assembly
(70) is configured to be an elongated, thin tubular assembly for
endoscopic use, but it should be understood that transmission
assembly (70) may alternatively be a short assembly, such as those
disclosed in U.S. Pat. Pub. No. 2007/0282333, entitled "Ultrasonic
Waveguide and Blade," published Dec. 6, 2007, and U.S. Pat. Pub.
No. 2008/0200940, entitled "Ultrasonic Device for Cutting and
Coagulating," published Aug. 21, 2008, the disclosures of which are
incorporated by reference herein. Transmission assembly (70) of the
present example comprises an outer sheath (72), an inner tubular
actuating member (not shown), a waveguide (not shown), and an end
effector (80) located on the distal end of transmission assembly
(70). In the present example, end effector (80) comprises a blade
(82) coupled to the waveguide, a clamp arm (84) operable to pivot
at the proximal end of transmission assembly (70), and, optionally,
one or more clamp pads (86) coupleable to clamp arm (84). It should
also be understood that clamp arm (84) and associated features may
be constructed and operable in accordance with at least some of the
teachings of U.S. Pat. No. 5,980,510, entitled "Ultrasonic Clamp
Coagulator Apparatus Having Improved Clamp Arm Pivot Mount," issued
Nov. 9, 1999, the disclosure of which is incorporated by reference
herein. The waveguide, which is adapted to transmit ultrasonic
energy from a transducer (100) to blade (82), may be flexible,
semi-flexible, or rigid. One merely exemplary ultrasonic transducer
(100) is Model No. HP054, sold by Ethicon Endo-Surgery, Inc. of
Cincinnati, Ohio. The waveguide may also be configured to amplify
the mechanical vibrations transmitted through the waveguide to
blade (82) as is well known in the art. The waveguide may further
have features to control the gain of the longitudinal vibration
along the waveguide and features to tune the waveguide to the
resonant frequency of the system.
[0036] In the present example, the distal end of the blade (82) is
disposed near an anti-node in order to tune the acoustic assembly
to a preferred resonant frequency f.sub.o when the acoustic
assembly is not loaded by tissue. When transducer (100) is
energized, the distal end of blade (82) is configured to move
longitudinally in the range of, for example, approximately 10 to
500 microns peak-to-peak, and preferably in the range of about 20
to about 200 microns at a predetermined vibratory frequency f.sub.o
of, for example, 55.5 kHz. When transducer (100) of the present
example is activated, these mechanical oscillations are transmitted
through the waveguide to end effector (80). In the present example,
blade (82), being coupled to the waveguide, oscillates at the
ultrasonic frequency. Thus, when tissue is secured between blade
(82) and clamp arm (84), the ultrasonic oscillation of blade (82)
may simultaneously sever the tissue and denature the proteins in
adjacent tissue cells, thereby providing a coagulative effect with
relatively little thermal spread. An electrical current may also be
provided through blade (82) and clamp arm (84) to also cauterize
the tissue. While some configurations for transmission assembly
(70) and transducer (100) have been described, still other suitable
configurations for transmission assembly (70) and transducer (100)
will be apparent to one or ordinary skill in the art in view of the
teachings herein.
[0037] Multi-piece handle assembly (60) of the present example
comprises a mating housing portion (62) and a lower portion (64).
Mating housing portion (62) is configured to receive transducer
(100) at a proximal end of mating housing portion (62) and to
receive the proximal end of transmission assembly (70) at a distal
end of mating housing portion (62). An aperture, described in more
detail below, is provided on the distal end of mating housing
portion (62) for insertion of various transmission assemblies (70).
A rotation knob (66) is shown in the present example to rotate
transmission assembly (70) and/or transducer (100), but it should
be understood that rotation knob (66) is merely optional. Lower
portion (64) of multi-piece handle assembly (60) includes a trigger
(68) and is configured to be grasped by a user using a single hand.
One merely exemplary alternative configuration for lower portion
(64) is depicted in FIG. 1 of U.S. Pat. Pub. No. 2011/0015660,
entitled "Rotating Transducer Mount for Ultrasonic Surgical
Instruments," published Jan. 20, 2011, the disclosure of which is
incorporated by reference herein. Toggle buttons (not shown) may be
located on a distal surface of lower portion (64) and may be
operable to activate transducer (100) at different operational
levels using generator (28). For instance, a first toggle button
may activate transducer (100) at a maximum energy level while a
second toggle button may activate transducer (100) at a minimum,
non-zero energy level. Of course, the toggle buttons may be
configured for energy levels other than a maximum and/or minimum
energy level as will be apparent to one of ordinary skill in the
art in view of the teachings herein. Moreover, the toggle buttons
may be located anywhere else on multi-piece handle assembly (60),
on transducer (100), and/or remote from surgical instrument (50),
and any number of toggle buttons may be provided. While multi-piece
handle assembly (60) has been described in reference to two
distinct portions (62, 64), it should be understood that
multi-piece handle assembly (60) may be a unitary assembly with
both portions (62, 64) combined. Multi-piece handle assembly (60)
may alternatively be divided into multiple discrete components,
such as a separate trigger portion (operable either by a user's
hand or foot) and a separate mating housing portion (62). The
trigger portion may be operable to activate transducer (100) and
may be remote from mating housing portion (62). Multi-piece handle
assembly (60) may be constructed from a durable plastic (such as
polycarbonate or a liquid crystal polymer), ceramics and/or metals
or any other suitable material as will be apparent to one of
ordinary skill in the art in view of the teachings herein. Still
other configurations for multi-piece handle assembly (60) will be
apparent to those of ordinary skill in the art in view of the
teachings herein. For instance, instrument (50) may be operated as
part of a robotic system. Other configurations for multi-piece
handle assembly (60) will also be apparent to those of ordinary
skill in the art in view of the teachings herein. By way of example
only, surgical instrument (50) may be constructed in accordance
with at least some of the teachings of U.S. Pat. No. 5,980,510;
U.S. Pat. Pub. No. 2006/0079874; U.S. Pat. Pub. No. 2007/0191713;
U.S. Pat. Pub. No. 2007/0282333; U.S. Pat. Pub. No. 2008/0200940;
U.S. Pat. Pub. No. 2011/0015660; U.S. Pat. No. 6,500,176; U.S. Pat.
Pub. No. 2011/0087218; and/or U.S. Pat. Pub. No. 2009/0143797.
Additional optional configurations and features for surgical
instrument (50) are described in U.S. patent application Ser. No.
13/269,899, entitled "Ultrasonic Surgical Instrument with Modular
End Effector," filed on Oct. 10, 2011, the disclosure of which is
incorporated by reference herein.
[0038] FIGS. 3A-3B depict an alternative version of an ultrasonic
instrument (101) having a reusable transducer and blade assembly
(102) for use in a handle assembly (120), and a detachable end
effector (150). Transducer and blade assembly (102) comprises a
transducer (104) and an elongated blade assembly coupled to
transducer (104) and extending distally from transducer (104).
Traducer (104) is operable to convert electrical power from cable
(112) into ultrasonic vibrations at blade (116). Transducer (104)
of the present example comprises a transducer body (106), a
circumferential notch (108) formed in a distal end of transducer
body (106), and a cable (112). Cable (112) of the present example
is coupleable to a power source, such as generator (28) described
above, to provide power to transducer (104). It should be
understood that transducer (104) may be configured to omit cable
(112), such as in a cordless transducer disclosed in U.S. Pat. Pub.
No. 2009/0143797, entitled "Cordless Hand-held Ultrasonic Cautery
Cutting Device," published Jun. 4, 2009, the disclosure of which is
incorporated by reference herein. Components of ultrasonic
instrument (101) may be constructed and operable in accordance with
the teachings of U.S. patent application Ser. No. 13/274,805, which
is incorporated by reference herein.
[0039] In the present example, casing (122) includes a proximal
aperture (124) configured to receive transducer and blade assembly
(102). Trigger (125) is pivotably coupled to casing (122) and is
configured to pivot from an open position to a closed position.
Trigger (125) is configured to actuate outer sheath (138) distally
via an actuation assembly (126) when trigger (125) is in the closed
position. Toggle buttons (128) comprise buttons operable to
selectively activate transducer (104) at different operational
levels using a power source and are operable in accordance with the
teachings of U.S. patent application Ser. No. 13/274,805, which is
incorporated by reference herein.
[0040] Rotation knob (136) is rotatably coupled to a distal end of
casing (122) and is coupled to outer sheath (138) and inner tubular
actuation member (140) to rotate outer sheath (138) and inner
tubular actuation member (140) relative to casing (122). In some
versions, outer sheath (138) and inner tubular actuation member
(140) are configured to selectively couple to rotation knob
(136).
[0041] FIG. 3A shows casing (122) with a proximal aperture (124)
configured to receive removable transducer and blade assembly
(102). Instrument (101) is capable of accommodating various kinds
of transducer and blade assemblies (102), including those with
different types of transducer bodies (106) and/or those with
different types of blades (116). End effector (150) is shown
aligned with outer sheath (138) and inner tubular actuation member
(140), but in a detached position. Initially the user inserts
transducer and blade assembly (102) through proximal aperture
(124). Assembly (102) is guided through inner tubular actuation
member (140) and out through the distal end of inner tubular
actuation member (140), as shown in FIG. 3B. When transducer and
blade assembly (102) is fully inserted, latch member (130) engages
notch (108) to retain transducer and blade assembly (102)
longitudinally within handle assembly (120). Latch member (130),
inner tubular actuation member (140), and transducer and blade
assembly (102) may be constructed and operable in accordance with
the teachings of U.S. patent application Ser. No. 13/274,805, which
is incorporated by reference herein. It should be understood that
transducer and blade assembly (102) can freely rotate relative to
handle assembly (120) while still maintaining an electrical
connection between electrical connector (132) and ring connector
(110). In addition, as transducer and blade assembly (102) is
inserted into handle assembly (120), a user may rotate transducer
and blade assembly (102) and/or inner tubular actuation member
(140) to align key (142) with a slot (not shown) of assembly (102).
Such an alignment maintains the orientation between blade (116) and
clamp arm (152) of end effector (150). In some versions, key (142)
may be provided on waveguide (114) and/or blade (116) to align
inner tubular actuation member (140) with waveguide (114) and/or
blade (116). Of course, transducer and blade assembly (102) and/or
components thereof may be removably coupled with casing (122) and
other components of instrument (101) in numerous other ways as will
be apparent to those of ordinary skill in the art in view of the
teachings herein.
[0042] With transducer and blade assembly (102) axially restrained
within handle assembly (120), end effector (150) of the present
example is then attached to outer sheath (138) and inner tubular
actuation member (140) as shown in FIG. 3B. It should be understood
that instrument (101) is capable of accommodating various kinds of
end effectors (150) as will be apparent to those of ordinary skill
in the art in view of the teachings herein. Outer sheath (138)
includes a circumferential groove (134) into which a portion of
actuation assembly (126) is insertable. It should be understood
that in some versions end effector (150) is coupled to outer sheath
(138) and inner tubular actuation member (140) prior to the
coupling of transducer and blade assembly (102). In the present
example, opposing L-shaped slots (148) of inner tubular actuation
member (140) and outer sheath (138) are aligned such that opposing
bayonet pins (154) are insertable into longitudinal portions (143)
of each L-shaped slot (148). When bayonet pins (154) reach the
proximal end of longitudinal portions (143), the user rotates end
effector (150) to rotate bayonet pins (154) into radial portions
(144) until bayonet pins reach lock portions (146). With end
effector (150) and transducer and blade assembly (102) coupled to
handle assembly (120), the user may then use the surgical
instrument for a procedure. Of course, end effector (150) and/or
components thereof may be removably coupled with transducer and
blade assembly (102) in numerous other ways as will be apparent to
those of ordinary skill in the art in view of the teachings
herein.
[0043] III. Overview of Exemplary Radiofrequency (RF) Surgical
Instrument
[0044] While some surgical instruments are adapted to use
ultrasonic energy to operate on tissue, other surgical instruments,
such as surgical instrument (159), shown in FIGS. 3-4, can be
configured to supply other kinds of energy, such as electrical
energy and/or heat energy, to the tissue of a patient.
[0045] FIGS. 4-5 show an exemplary electrosurgical instrument (159)
that is constructed and operable in accordance with at least some
of the teachings of U.S. Pat. No. 6,500,176; U.S. Pat. No.
7,112,201; U.S. Pat. No. 7,125,409; U.S. Pat. No. 7,169,146; U.S.
Pat. No. 7,186,253; U.S. Pat. No. 7,189,233; U.S. Pat. No.
7,220,951; U.S. Pat. No. 7,309,849; U.S. Pat. No. 7,311,709; U.S.
Pat. No. 7,354,440; U.S. Pat. No. 7,381,209; U.S. Pub. No.
2011/0087218; and/or U.S. patent application Ser. No. 13/151,181.
As described therein and as will be described in greater detail
below, electrosurgical instrument (159) is operable to cut tissue
and seal or weld tissue (e.g., a blood vessel, etc.) substantially
simultaneously. In other words, electrosurgical instrument (159)
operates similar to an endocutter type of stapler, except that
electrosurgical instrument (159) provides tissue welding through
application of bipolar RF energy instead of providing lines of
staples to join tissue. It should also be understood that
electrosurgical instrument (159) may have various structural and
functional similarities with the ENSEAL.RTM. Tissue Sealing Device
by Ethicon Endo-Surgery, Inc., of Cincinnati, Ohio. Furthermore,
electrosurgical instrument (159) may have various structural and
functional similarities with the devices taught in any of the other
references that are cited and incorporated by reference herein. To
the extent that there is some degree of overlap between the
teachings of the references cited herein, the ENSEAL.RTM. Tissue
Sealing Device by Ethicon Endo-Surgery, Inc., of Cincinnati, Ohio,
and the following teachings relating to electrosurgical instrument
(159), there is no intent for any of the description herein to be
presumed as admitted prior art. Several teachings below will in
fact go beyond the scope of the teachings of the references cited
herein and the ENSEAL.RTM. Tissue Sealing Device by Ethicon
Endo-Surgery, Inc., of Cincinnati, Ohio.
[0046] A. Exemplary Handpiece and Shaft
[0047] Electrosurgical instrument (159) of the present example
includes a handpiece (160), a transmission assembly or shaft (170)
extending distally from handpiece (160), and an end effector (180)
disposed at a distal end of shaft (170). Handpiece (160) of the
present example includes a pistol grip (162), a pivoting trigger
(164), an activation button (166), and an articulation control
(168). Trigger (164) is pivotable toward and away from pistol grip
(162) to selectively actuate end effector (180) as will be
described in greater detail below. Activation button (166) is
operable to selectively activate RF circuitry that is in
communication with end effector (180), in a manner described in
U.S. patent application Ser. No. 13/235,660 and/or various other
references that are cited and incorporated by reference herein. In
some versions, activation button (166) also serves as a mechanical
lockout against trigger (164), such that trigger (164) cannot be
fully actuated unless button (166) is being pressed simultaneously.
Examples of how such a lockout may be provided are disclosed in one
or more of the references cited herein. It should be understood
that pistol grip (162), trigger (164), and button (166) may be
modified, substituted, supplemented, etc. in any suitable way, and
that the descriptions of such components herein are merely
illustrative. Articulation control (168) of the present example is
operable to selectively control articulation section (176) of shaft
(170) in a manner described in U.S. patent application Ser. No.
13/235,660, which is incorporated by reference herein.
[0048] Shaft (170) of the present example includes an outer sheath
(172) and an articulation section (176). Articulation section (176)
is operable to selectively position end effector (180) at various
angles relative to the longitudinal axis defined by sheath (172).
Various examples of forms that articulation section (176) and other
components of shaft (170) may take are described in U.S. patent
application Ser. No. 13/235,623, entitled "Control Features for
Articulating Surgical Device," filed Sep. 19, 2011, the disclosure
of which is incorporated by reference herein. For instance, it
should be understood that various components that are operable to
actuate articulation section (176) may extend through the interior
of sheath (172). In some versions, shaft (170) is also rotatable
about the longitudinal axis defined by sheath (172), relative to
handpiece (160), via a knob (174). Such rotation may provide
rotation of end effector (180) and shaft (170) unitarily. In some
other versions, knob (174) is operable to rotate end effector (180)
without rotating any portion of shaft (170) that is proximal of
articulation section (176). As another merely illustrative example,
electrosurgical instrument (159) may include one rotation control
that provides rotatability of shaft (170) and end effector (180) as
a single unit; and another rotation control that provides
rotatability of end effector (180) without rotating any portion of
shaft (170) that is proximal of articulation section (176). Other
suitable rotation schemes will be apparent to those of ordinary
skill in the art in view of the teachings herein. Of course,
rotatable features may simply be omitted if desired.
[0049] B. Exemplary End Effector
[0050] End effector (180) of the present example comprises a first
jaw (182) and a second jaw (184). In the present example, second
jaw (184) is substantially fixed relative to shaft (170); while
first jaw (182) pivots relative to shaft (170), toward and away
from second jaw (184). In some versions, actuators such as rods or
cables, etc., may extend through sheath (172) and be joined with
first jaw (182) at a pivotal coupling (183), such that longitudinal
movement of the actuator rods/cables/etc. through shaft (170)
provides pivoting of first jaw (182) relative to shaft (170) and
relative to second jaw (184). Of course, jaws (182, 184) may
instead have any other suitable kind of movement and may be
actuated in any other suitable fashion. By way of example only, and
as will be described in greater detail below, jaws (182, 184) may
be actuated and thus closed by longitudinal translation of a firing
beam (195), such that actuator rods/cables/etc. may simply be
eliminated in some versions.
[0051] As best seen in FIGS. 4-5, first jaw (182) defines a
longitudinally extending elongate slot (186); while second jaw
(184) also defines a longitudinally extending elongate slot (148).
In addition, the top side of first jaw (182) presents a first
electrode surface (190); while the underside of second jaw (184)
presents a second electrode surface (192). Electrode surfaces (190,
192) are in communication with an electrical source (198) via one
or more conductors (not shown) that extend along the length of
shaft (170). Electrical source (198) is operable to deliver RF
energy to first electrode surface (190) at a first polarity and to
second electrode surface (192) at a second (opposite) polarity,
such that RF current flows between electrode surfaces (190, 192)
and thereby through tissue captured between jaws (182, 184). In
some versions, firing beam (195) serves as an electrical conductor
that cooperates with electrode surfaces (190, 192) (e.g., as a
ground return) for delivery of bipolar RF energy captured between
jaws (182, 184). Electrical source (198) may be external to
electrosurgical instrument (159) or may be integral with
electrosurgical instrument (159) (e.g., in handpiece (160), etc.),
as described in one or more references cited herein or otherwise. A
controller (199) regulates delivery of power from electrical source
(198) to electrode surfaces (190, 192). Controller (199) may also
be external to electrosurgical instrument (159) or may be integral
with electrosurgical instrument (159) (e.g., in handpiece (160),
etc.), as described in one or more references cited herein or
otherwise. It should also be understood that electrode surfaces
(190, 192) may be provided in a variety of alternative locations,
configurations, and relationships.
[0052] The lower side of first jaw (182) includes a longitudinally
extending recess (not shown) adjacent to slot (186); while the
upper side of second jaw (184) includes a longitudinally extending
recess (not shown) adjacent to slot (188). FIG. 4 shows the upper
side of first jaw (182) including a plurality of teeth serrations
(194). It should be understood that the lower side of second jaw
(184) may include complementary serrations that nest with
serrations (194), to enhance gripping of tissue captured between
jaws (182, 184) without necessarily tearing the tissue. Serrations
(194) may be constructed and operable in accordance with the
teachings of U.S. patent application Ser. No. 13/235,660 and/or
various other references that are cited and incorporated by
reference herein.
[0053] With jaws (182, 184) in a closed position, shaft (170) and
end effector (180) are sized and configured to fit through trocars
having various inner diameters, such that electrosurgical
instrument (159) is usable in minimally invasive surgery, though of
course electrosurgical instrument (159) could also be used in open
procedures if desired. Shaft (170) and end effector (180) may be
constructed and operable in accordance with the teachings of U.S.
patent application Ser. No. 13/235,660 and/or various other
references that are cited and incorporated by reference herein.
[0054] In some versions, end effector (180) includes one or more
sensors (not shown) that are configured to sense a variety of
parameters at end effector (180), including but not limited to
temperature of adjacent tissue, electrical resistance or impedance
of adjacent tissue, voltage across adjacent tissue, forces exerted
on jaws (182, 184) by adjacent tissue, etc. By way of example only,
end effector (180) may include one or more positive temperature
coefficient (PTC) thermistor bodies (e.g., PTC polymer, etc.),
located adjacent to electrodes (190, 192) and/or elsewhere. Data
from sensors may be communicated to controller (199). Controller
(199) may process such data in a variety of ways. By way of example
only, controller (199) may modulate or otherwise change the RF
energy being delivered to electrode surfaces (190, 192), based at
least in part on data acquired from one or more sensors at end
effector (180). In addition or in the alternative, controller (199)
may alert the user to one or more conditions via an audio and/or
visual feedback device (e.g., speaker, lights, display screen,
etc.), based at least in part on data acquired from one or more
sensors at end effector (180). It should also be understood that
some kinds of sensors need not necessarily be in communication with
controller (199), and may simply provide a purely localized effect
at end effector (180). For instance, a PTC thermistor bodies (not
shown) at end effector (40) may automatically reduce the energy
delivery at electrode surfaces (190, 192) as the temperature of the
tissue and/or end effector (180) increases, thereby reducing the
likelihood of overheating. In some such versions, a PTC thermistor
element is in series with power source (198) and electrode surface
(190, 192); and the PTC thermistor provides an increased impedance
(reducing flow of current) in response to temperatures exceeding a
threshold. Furthermore, it should be understood that electrode
surfaces (190, 192) may be used as sensors (e.g., to sense tissue
impedance, etc.). Various kinds of sensors that may be incorporated
into electrosurgical instrument (159) will be apparent to those of
ordinary skill in the art in view of the teachings herein.
Similarly various things that can be done with data from sensors,
by controller (199) or otherwise, will be apparent to those of
ordinary skill in the art in view of the teachings herein. Other
suitable variations for end effector (180) will also be apparent to
those of ordinary skill in the art in view of the teachings
herein.
[0055] C. Exemplary Firing Beam
[0056] As also seen in FIGS. 4-5, electrosurgical instrument (159)
of the present example includes a firing beam (195) that is
longitudinally movable along part of the length of end effector
(180). Firing beam (195) is coaxially positioned within shaft
(170), extends along the length of shaft (170), and translates
longitudinally within shaft (170) (including articulation section
(176) in the present example), though it should be understood that
firing beam (195) and shaft (170) may have any other suitable
relationship. Firing beam (195) includes a sharp distal blade
(197), an upper flange (196), and a lower flange (not shown).
Firing beam (195) may be constructed and operable in accordance
with the teachings of U.S. patent application Ser. No. 13/235,660
and/or various other references that are cited and incorporated by
reference herein. Distal blade (197) extends through slots (186,
188) of jaws (182, 184), with upper flange (196) being located
above jaw (184) in a recess (not shown) and the lower flange (not
shown) being located below jaw (182) in a recess (not shown). The
configuration of distal blade (197), upper flange (196), and the
lower flange (not shown) provides an "I-beam" type of cross section
at the distal end of firing beam (195) and may be constructed and
operable in accordance with the teachings of U.S. patent
application Ser. No. 13/235,660 and/or various other references
that are cited and incorporated by reference herein.
[0057] Distal blade (197) is substantially sharp, such that distal
blade will readily sever tissue that is captured between jaws (182,
184). Distal blade (197) is also electrically grounded in the
present example, providing a return path for RF energy as described
elsewhere herein. In some other versions, distal blade (197) serves
as an active electrode. In addition or in the alternative, distal
blade (197) may be selectively energized with ultrasonic energy
(e.g., harmonic vibrations at approximately 55.5 kHz, etc.).
[0058] The "I-beam" type of configuration of firing beam (195)
provides closure of jaws (182, 184) as firing beam (195) is
advanced distally. In particular, flange (196) urges jaw (184)
pivotally toward jaw (182) as firing beam (195) is advanced from a
proximal position to a distal position, by bearing against a recess
(not shown) formed in jaw (184). This closing effect on jaws (182,
184) by firing beam (195) may occur before distal blade (197)
reaches tissue captured between jaws (182, 184). Such staging of
encounters by firing beam (195) may reduce the force required to
squeeze grip (164) to actuate firing beam (195) through a full
firing stroke. In other words, in some such versions, firing beam
(195) may have already overcome an initial resistance required to
substantially close jaws (182, 184) on tissue before encountering
resistance from the tissue captured between jaws (182, 184). Of
course, any other suitable staging may be provided.
[0059] In the present example, flange (196) is configured to cam
against a ramp feature at the proximal end of jaw (184) to open jaw
(182) when firing beam (195) is retracted to a proximal position
and to hold jaw (182) open when firing beam (195) remains at the
proximal position. This camming capability may facilitate use of
end effector (180) to separate layers of tissue, to perform blunt
dissections, etc., by forcing jaws (182, 184) apart from a closed
position. In some other versions, jaws (182, 184) are resiliently
biased to an open position by a spring or other type of resilient
feature. While jaws (182, 184) close or open as firing beam (195)
is translated in the present example, it should be understood that
other versions may provide independent movement of jaws (182, 184)
and firing beam (195). By way of example only, one or more cables,
rods, beams, or other features may extend through shaft (170) to
selectively actuate jaws (182, 184) independently of firing beam
(195). Such jaw (182, 184) actuation features may be separately
controlled by a dedicated feature of handpiece (160).
Alternatively, such jaw actuation features may be controlled by
trigger (164) in addition to having trigger (164) control firing
beam (195). It should also be understood that firing beam (195) may
be resiliently biased to a proximal position, such that firing beam
(195) retracts proximally when a user relaxes their grip on trigger
(164).
[0060] D. Exemplary Operation
[0061] In an exemplary use, end effector (180) is inserted into a
patient via a trocar. Articulation section (176) is substantially
straight when end effector (180) and part of shaft (170) are
inserted through the trocar. Articulation control (168) may then be
manipulated to pivot or flex articulation section (176) of shaft
(170) in order to position end effector (180) at a desired position
and orientation relative to an anatomical structure within the
patient. Two layers of tissue of the anatomical structure are then
captured between jaws (182, 184) by squeezing trigger (164) toward
pistol grip (162). Such layers of tissue may be part of the same
natural lumen defining anatomical structure (e.g., blood vessel,
portion of gastrointestinal tract, portion of reproductive system,
etc.) in a patient. For instance, one tissue layer may comprise the
top portion of a blood vessel while the other tissue layer may
comprise the bottom portion of the blood vessel, along the same
region of length of the blood vessel (e.g., such that the fluid
path through the blood vessel before use of electrosurgical
instrument (159) is perpendicular to the longitudinal axis defined
by end effector (180), etc.). In other words, the lengths of jaws
(182, 184) may be oriented perpendicular to (or at least generally
transverse to) the length of the blood vessel. As noted above,
flanges (162, 166) cammingly act to pivot jaw (182) toward jaw
(184) when firing beam (195) is actuated distally by squeezing
trigger (164) toward pistol grip (162).
[0062] With tissue layers captured between jaws (182, 184) firing
beam (195) continues to advance distally by the user squeezing
trigger (164) toward pistol grip (162). As firing beam (195)
advances distally, distal blade (197) simultaneously severs the
clamped tissue layers, resulting in separated upper layer portions
being apposed with respective separated lower layer portions. In
some versions, this results in a blood vessel being cut in a
direction that is generally transverse to the length of the blood
vessel. It should be understood that the presence of upper flange
(162) and the lower flange (not shown) immediately above and below
jaws (182, 184), respectively, may help keep jaws (182, 184) in a
closed and tightly clamping position. In particular, flanges (162,
166) may help maintain a significantly compressive force between
jaws (182, 184). With severed tissue layer portions being
compressed between jaws (182, 184), electrode surfaces (190, 192)
are activated with bipolar RF energy by the user depressing
activation button (166). In some versions, electrodes (190, 192)
are selectively coupled with power source (198) (e.g., by the user
depressing button (166), etc.) such that electrode surfaces (190,
192) of jaws (182, 184) are activated with a common first polarity
while firing beam (195) is activated at a second polarity that is
opposite to the first polarity. Thus, a bipolar RF current flows
between firing beam (195) and electrode surfaces (190, 192) of jaws
(182, 184), through the compressed regions of severed tissue layer
portions. In some other versions, electrode surface (190) has one
polarity while electrode surface (192) and firing beam (195) both
have the other polarity. In either version (among at least some
others), bipolar RF energy delivered by power source (198)
ultimately thermally welds the tissue layer portions on one side of
firing beam (195) together and the tissue layer portions on the
other side of firing beam (195) together.
[0063] In certain circumstances, the heat generated by activated
electrode surfaces (190, 192) can denature the collagen within the
tissue layer portions and, in cooperation with clamping pressure
provided by jaws (182, 184), the denatured collagen can form a seal
within the tissue layer portions. Thus, the severed ends of the
natural lumen defining anatomical structure are hemostatically
sealed shut, such that the severed ends will not leak bodily
fluids. In some versions, electrode surfaces (190, 192) may be
activated with bipolar RF energy before firing beam (195) even
begins to translate distally and thus before the tissue is even
severed. For instance, such timing may be provided in versions
where button (166) serves as a mechanical lockout relative to
trigger (164) in addition to serving as a switch between power
source (198) and electrode surfaces (190, 192).
[0064] While several of the teachings below are described as
variations of instruments (10, 50, 101, 159), it should be
understood that various teachings below may also be incorporated
into various other types of devices. By way of example only, in
addition to being readily incorporated into instruments (10, 50,
101, 159), various teachings below may be readily incorporated into
the devices taught in any of the references cited herein, surgical
staplers, surgical clip appliers, and tissue graspers, among
various other devices. Other suitable devices into which the
following teachings may be incorporated will be apparent to those
of ordinary skill in the art in view of the teachings herein. Of
course end effectors (16, 80, 150, 180) and surgical instruments
(10, 50, 101, 159) may also include other configurations as will be
apparent to one of ordinary skill in the art in view of the
teachings herein.
[0065] IV. Exemplary Coupling Mechanisms for Modular Shafts and End
Effectors
[0066] In some instances it may be useful to change between various
shaft lengths and/or types of end effectors (16, 80, 150, 180)
while using the same handle assembly (60, 120, 160). For instance,
in some procedures, a large amount of tissue may need to be cut,
requiring different length end effectors (80, 150, 180) and/or
shafts for transmission assemblies (70, 102, 170). Such
interchangeable shafts and/or end effectors (80, 150, 180) may
permit a common handle assembly (60, 120, 160) to be used for
various surgical procedures (e.g., short shafts for open surgery,
long shafts for minimally invasive laparoscopic surgery, etc.).
Moreover, changing out the shafts and/or the end effectors (80,
150, 180) while reusing the same handle assembly (60, 120, 160) may
be more time and/or cost effective than using a new surgical
instrument (50, 101, 159) with the different length shaft. By way
of example only, such shafts and/or end effectors (80, 150, 180)
may include color codes to distinguish the various lengths and/or
types. In another instance, the handle assembly (60, 120, 160) may
be configured to employ different types of end effectors, for
instance, the handle assembly (60, 120, 160) may include components
to operate an ultrasonic end effector (80, 150) and/or an RF end
effector (180). Thus, changing the shafts and end effectors (80,
150, 180) with a common handle assembly (60, 120, 160) may conserve
time and/or costs. Accordingly, various coupling mechanisms for
coupling the modular shafts to the handle assemblies (60, 120, 160)
are described below. It should be understood that in versions where
an ultrasonic end effector (80) is used, at least part of
transducer (100) may be integral with the shaft and end effector
(80), and may thus be selectively coupled with handle assembly
(60). Alternatively, transducer (100) may be integral with handle
assembly (60) such that the shaft and end effector (80) are
selectively coupled with transducer (100) when the shaft and end
effector (80) are selectively coupled with handle assembly
(60).
[0067] An exemplary coupling mechanism (200) comprises a threaded
slip nut (230) disposed about a shaft (220) of an exemplary end
effector assembly (210), shown in FIGS. 6A-6B. In the present
example, end effector assembly (210) comprises a transmission
assembly (212), a rotation knob (214), and a shaft (220) extending
proximally relative to rotation knob (214). It should be understood
that rotation knob (214) is merely optional and may be omitted.
Rotation knob (214) is operable to rotate transmission assembly
(212) relative to a handle assembly (240) and/or shaft (220). An
end effector (not shown) is coupled to a distal end of transmission
assembly (212). The end effector may include an ultrasonic end
effector (80, 150), an RF end effector (180), and/or any other end
effector or combination of end effectors as will be apparent to one
of ordinary skill in the art in view of the teachings herein.
Transmission assembly (212) is operable to communicate energy
(e.g., ultrasonic vibrations, RF energy, and/or mechanical
motion/force, etc.) from a source proximal to transmission assembly
(212) to an end effector at the distal end of transmission assembly
(212). In the instance of an ultrasonic end effector, such as end
effector (80), an axial bore (not shown) through shaft (220) may
permit mechanical coupling of transmission assembly (212) through
shaft (220) to components within handle assembly (240), which may
be configured in a similar manner to multi-piece handle assembly
(60) described above. In the case of an RF end effector, such as
end effector (180), the axial bore may permit a portion of
transmission assembly (212) to extend at least partially through
shaft (220). Transmission assembly (212) may include an inner slip
ring connector that is electrically coupleable to a complementary
slip ring connector on the interior of shaft (220) such that an
electrical coupling from handle assembly (240) may be made to the
end effector. In yet another alternative, a fluid coupling may also
be made via the bore through shaft (220) and/or elsewhere on end
effector assembly (210).
[0068] In the present example, a threaded slip nut (230) is
slidably disposed about shaft (220). Threaded slip nut (230)
includes a keyway (232) (shown in phantom) at a proximal end of
threaded slip nut (230). It should be understood that keyway (232)
may alternatively be located on a distal end of threaded slip nut
(230). Keyway (232) of the present example only partially extends
through threaded slip nut (230), though keyway (232) may
alternatively extend completely through threaded slip nut (230). As
shown in FIGS. 8A-8B, keyway (232) is configured to receive a keyed
portion (222) of shaft (220). In the present example, keyed portion
(222) of shaft (220) is located near a proximal end of shaft (220)
and extends outwardly from shaft (220), though it should be
understood that keyed portion (222) may alternatively be located
distally near rotation knob (214) or at a midpoint of shaft (220).
In one merely alternative example, keyed portion (222) may be
slidable relative to shaft (220), such as by actuation of a slider
to slide keyed portion (222) into keyway (232). Shaft (220) further
comprises a proximal flange (224) located on the proximal end of
shaft (220) and sized to prevent threaded slip nut (230) from
sliding proximally off of shaft (220). As will be described below,
keyed portion (222) is insertable into keyway (232) when a user
desires to thread threaded slip nut (230) into internal threading
(250) of handle assembly (240). Threaded slip nut (230) of the
present example may then be slid distally on shaft (220) to
disengage keyed portion (222) from keyway (232), thereby permitting
shaft (220), rotation knob (214), and/or transmission assembly
(212) to rotate freely relative to threaded slip nut (230) and/or
handle assembly (240).
[0069] In some instance threaded slip nut (230) may be slidably
disposed on an inner tube, such as an inner tubular actuating
member described above. In such a configuration, threaded slip nut
(230) may be configured to thread into a yoke, such as trigger yoke
(185) described in U.S. Pat. Pub. No. 2011/0015660, entitled
"Rotating Transducer Mount for Ultrasonic Surgical Instruments,"
published Jan. 20, 2011, the disclosure of which is incorporated by
reference herein. A blade, such as blade (82) described above, may
be coupled to a transducer, such as transducer (100) described
above. The inner tubular actuating member may be actuated via the
coupling of threaded slip nut (230) to the yoke. Accordingly, a
clamp arm, such as clamp arm (84) described above, may be operable
to clamp tissue against the blade.
[0070] In the present example, handle assembly (240) is shown
having a distal aperture (242) formed within a casing (244) and
configured to receive shaft (220) and threaded slip nut (230) of
end effector assembly (210). Handle assembly (240) may further be
configured in accordance with at least some of the teachings for
multi-piece handle assembly (60), for handle assembly (152), of
U.S. Pat. Pub. No. 2011/0015660, entitled "Rotating Transducer
Mount for Ultrasonic Surgical Instruments," published Jan. 20,
2011, or of U.S. Pat. No. 6,500,176, entitled "Electrosurgical
Systems and Techniques for Sealing Tissue," issued Dec. 31, 2002,
the disclosures of which are incorporated by reference herein,
and/or in any other suitable fashion. In the present example,
handle assembly (240) includes a member (248) having internal
threading (250) disposed about a member aperture (252). Internal
threading (250) and threaded slip nut (230) are configured to
thread together to secure end effector assembly (210) to handle
assembly (240).
[0071] As shown in the sequence of FIGS. 6A-6B, threaded slip nut
(230) of the present example is slid proximally such that keyed
portion (222) of shaft (220) engages keyway (232) of threaded slip
nut (230). With the rotational freedom of threaded slip nut (230)
restricted by the engagement of keyed portion (222) and keyway
(232), a user then threads threaded slip nut (230) into internal
threading (250) of handle assembly (240). For instance, an L-shaped
spacer tool may be used to urge threaded slip nut (230) proximally
on shaft (220) against flange (224) while the user threads threaded
slip nut (230) into internal threading (250). Alternatively, a user
may manually urge threaded slip nut (230) proximally. Further
still, a slider, as noted above, may engage a portion of threaded
slip nut (230) to urge threaded slip nut (230) proximally. Of
course, still other methods of urging threaded slip nut (230)
proximally to engage keyed portion (222) and keyway (232) will be
apparent to those of ordinary skill in the art in view of the
teachings herein. For instance, a spring (not shown) may be
disposed about shaft (220) distally of slip nut (230) and
proximally of rotation knob (214), thereby biasing slip nut (230)
proximally such that keyway (232) is engaged with keyed portion
(222). When the user desires to rotate end effector assembly (210),
the user grasps rotation knob (214) and pushes end effector
assembly (210) proximally until keyed portion (222) disengages from
keyway (232).
[0072] Once threaded slip nut (230) has been sufficiently threaded
into internal threading (250) (for instance, a torque limiting tool
may be used), end effector assembly (210) is slid proximally to
disengage keyed portion (222) from keyway (232). End effector
assembly (210) may be manually slid distally or, in one
alternative, a spring (not shown) located between flange (224) and
threaded slip nut (230) may urge end effector assembly (210)
distally. In the instance of an ultrasonic instrument, shaft (220)
of end effector assembly (210) may be threaded onto a horn of a
transducer, such as transducer (100) described above. Such
threading may occur prior to, contemporaneously with, or after the
threading of threaded slip nut (230) into internal threading (250).
Alternatively, in the instance of an RF instrument, shaft (220) may
be coupled to one or more electrical connectors (not shown) to
couple the end effector to a power source. As shown in FIG. 6B, end
effector assembly (210) is effectively longitudinally secured to
handle assembly (240) while permitting rotational movement of shaft
(220), rotation knob (214), and/or transmission assembly (212). A
user may then use the assembled surgical instrument for a
procedure. When the user desires to decouple end effector assembly
(210) from handle assembly (240), the user pulls end effector
assembly (210) distally until keyed portion (222) of shaft (220)
engages keyway (232) of threaded slip nut (230). Alternatively, the
L-shaped spacer tool may be wedged between threaded slip nut (230)
and rotation knob (214) to urge threaded slip nut (230) proximally.
With keyed portion (222) and keyway (232) engaged, the user may
then unscrew threaded slip nut (230) from internal threading (250),
thereby decoupling end effector assembly (210) from handle assembly
(240). A user may then couple a new end effector assembly (210) to
handle assembly (240).
[0073] Of course other configurations for coupling mechanism (200)
will be apparent to one of ordinary skill in the art in view of the
teachings herein. For instance, threaded slip nut (230) may be
located between flange (224) and another annular flange (not shown)
of shaft (220). In this example, keyed portion (222) may be
actuated radially outward from an initial position within a recess
(not shown) of shaft (220) to a position where keyed portion (222)
engages keyway (232) of threaded slip nut (230). For instance,
keyed portion (222) may be actuated by a cam member coupled to a
slider located on transmission assembly (212) and/or rotation knob
(214). As will become apparent from the previous and later
disclosures herein, various other electrical and/or mechanical
coupling mechanisms and/or features may be used to substitute
coupling mechanism (200), to modify coupling mechanism (200), or to
combine with coupling mechanism (200).
[0074] V. Exemplary Information Transmission System
[0075] FIG. 7 shows a schematic view of an information transmission
system (300) using device (10) to transmit information. It should
be understood that various kinds of devices or instruments (10, 24,
101, 159) may be used in system (300) alongside removable end
effectors (16, 80, 150, 180), respective transmission assemblies
(70, 102, 170), and reusable handle assemblies (60, 120, 160) where
it may be useful to change between various shaft lengths and/or
types, as described above. Device (10) is shown as connected to
generator (28), as described above, though generator (28) may be
incorporated into device (10) or omitted in some versions. Sensor
(20) in device (10), which may be included in any of instruments
(24, 101, 159), may gather information regarding use of device (10)
during a surgical procedure on a patient. Such information may be
transmitted to generator (28), which then transmits the information
via a secure gateway (302) to a secure server (304). Gateway (302)
of the present example includes Secure Web Gateway (SWG) technology
combining features such as anti-malware, URL filtering, web content
filtering, bandwidth management, application control, and/or
caching capabilities in order to secure, monitor, and control
traffic between generator (28) and server (304), regardless of
whether such traffic is encrypted or not. Server (304), which may
be a secure server outside a hospital network, communicates the
information via a secure web interface (306) to a unique patient
file (308). Patient file (308) includes patient history specific to
the first patient on whom device (10) was used during the surgical
procedure from which information was collected and transmitted. The
particular device (10) and components used on the first patient may
be, for example, tracked and entered into patient file (308) via
the system shown in FIG. 7. Information may be shared to patient
file (308) directly after use of device (10) in the associated
surgical procedure performed on the first patient. To the extent
that a hospital desires to track patient care throughout an entire
experience associated with a patient, including but not limited
information such as the types of tools, services, and materials
that were used on or for a patient during that patient's hospital
experience, system (300) assists with this goal by providing
desired information regarding device (10) used with a patient
during a particular surgical procedure. By tracking information
such as amount of time a device such as device (10) and its
attached and/or removable components were used on a patient along
with electrical characteristics associated with such use, and the
types of device and/or device components used, a cost may be
calculated based on the tracked information. Further, by tracking
such information and data monitoring, analysis and recommendations
for future surgical improvements may be obtained from the tracked
procedure data to improve outcomes of and to build best practices
for similar future surgeries. Hospitals using system (300) may
control what type of data tracked during use of device (10) is
associated with a specific patient that device (10) was used upon
during a surgical procedure, and thus which data is viewable in
patient file (308). System (300) transmits information via a secure
process as described below.
[0076] FIGS. 8A-8B show an exemplary process that may be carried
out using system (300). Unique serial numbers may be associated
with particular types of instruments (10, 24, 101, 159) and/or
medical device components, such as removable end effectors (16, 80,
150, 180), and respective transmission assemblies (70, 102, 170),
and handle assemblies (60, 120, 160). Each unique serial number of
device (10), for example, and components associated with device
(10), is received (500) by generator (28). For example, such data
may be transmitted to and received by generator (28) via a wired or
wireless connection, may be manually inputted into a user interface
in communication with generator (28), and/or may be automatically
registered by generator (28) via a receiver in communication with
generator (28). For ease of reference, regarding use with system
(300), when device (10) is referenced alongside its components, it
is understood that any of devices or instruments (10, 24, 101, 159)
alongside respective removable end effectors (16, 80, 150, 180),
and respective transmission assemblies (70, 102, 170), and
respective handle assemblies (60, 120, 160) may be used in place of
device (10) and its components. Additionally or alternatively,
generator (28) may be removed from system (300) and information
from sensor (20) of device (10), or other instruments such as
instrument (159), for example, may be transmitted wirelessly and/or
via a wired communication to secure gateway (302).
[0077] Information such as the type of device (10) and type of end
effector (16) used, or that of any of the instruments, end
effectors, transmission assemblies, and/or handle assemblies within
the present disclosure, and the amount of time such components were
used during a surgical procedure on a patient are transmitted via
system (300) to server (304). System (300) may also transmit
information indicating the type of surgical procedure to server
(304). Other suitable types of information that may be transmitted
to server (304) will be apparent to one of ordinary skill in the
art in view of the teachings herein. As shown in FIG. 8, unique
serial numbers of medical device components used or to be used in a
surgical procedure, are received (500) in generator (28). A
security or secure key is or has been coded (502) into secure
gateway (302). The medical device components are then used on a
first patient during a surgical procedure. Data is captured (504)
in device (10), for example, during the surgical procedure on the
first patient via sensor (20) in device (10). As described above,
such data may include a sensed temperature at end effector (16), a
determined oscillation rate of end effector (16), the impedance of
tissue encountered by end effector (16) and/or other properties of
such tissue, motions of end effector (16) during a surgical
procedure (e.g., when sensor (20) includes an accelerometer),
and/or other data as will be apparent to one of ordinary skill in
the art in view of the teachings herein. Information including the
captured data and the unique serial numbers associated with the
used device (10) and end effector (16), for example, is transmitted
(506) to generator (28). Generator (28) may be connected via, for
example, a USB port, ethernet, or other wired or wireless
connection to secure gateway (302) in a one-way or two-way
connection. The gathered information is thereby uploaded (508) to
secure gateway (302) via generator (28). It should be understood
that any step within steps (500-508) may be performed at any
suitable time. For instance, step (508) may be carried out through
a continuous data stream throughout the surgical procedure.
Alternatively, step (508) may be carried out after the procedure is
complete. Other time frames and relationships will be apparent to
one of ordinary skill in the art in view of the teachings
herein.
[0078] As shown in FIG. 8B, after the surgical procedure is
compete, a call is initiated (510) to secure server (304) to
request the previously coded secure key. Server (304) replies (512)
to the call request with the previously coded secure key. The
secure key is validated (514) via secure gateway (302) after being
received. Upon successful completion of the secure key validation,
an upload of information to secure server (304) is initiated (516)
via secure gateway (302). The uploaded information is transmitted
(518) via secure server (304) to patient file (308) associated with
the first patient that underwent the surgical procedure using
device (10) and end effector (16). In some instances a cost is
determined (520) based on the transmitted, uploaded information in
patient file (308), amount of time used and data regarding use of
device (10) and end effector (16), and other device components,
and/or other information. For instance, a dollar amount may be
associated with minutes of use for device (10), for an amount of
voltage used via a connection between generator (28) and device
(10) for application on tissue of the first patient during the
surgical procedure, total energy used by device (10), total current
used by device (10), number of activations of device (10), and/or
various other parameters, including various combinations of
parameters. The retrieved information may be tallied and a pre-set
calculation may be applied to the retrieved information to generate
an overall cost of use associated with device (10) during the
surgical procedure on the first patient. The tallied cost may be
stored in patient file (308) and displayed on, for example, a
computer monitor or other user information or printed on one or
more reports generated from patient file (308). A hospital may
track costs associated across various patients with devices and/or
components having certain serial numbers to analyze results and
view which types of devices and/or components may be more costly
than others or might be desirably used in certain types of
surgeries in a cost-effective and time-effective manner.
[0079] The tallied cost may also be submitted to an outside server
(304) as an invoice that the hospital might pay to one or more
vendors or manufacturers of device (10), end effector (16), and/or
other components of device (10). Server (304) also may play the
function of notifying a hospital information technology system that
new data has been logged into a patient file (308) along with
information regarding the time of receipt of the logged information
and other suitable information as apparent to one of ordinary skill
in the art in view of the teachings herein. Of course, the
instrument usage data need not necessarily be used for establishing
usage costs or controls. For instance, usage data may be used as a
measure of surgical time, surgeon/operator performance, efficiency,
effectiveness, etc. Other suitable ways in which instrument usage
data might be used will be apparent to one of ordinary skill in the
art in view of the teachings herein.
[0080] VI. Exemplary Sensor to Track Instrument Usage
Characteristics
[0081] FIGS. 9-12 show graphical views of sample instrument usage
characteristics trackable on device (10) during a surgical
procedure on a patient, for example, via sensor (20) of device
(10). Sensor (20) in an example may track a technique that a
surgeon uses on device (10) during the procedure. Feedback from
sensor (20), for example, may be transmitted via a wired or
wireless connection to a receiving device such as server (304) or
other suitable device, such as a computer or smartphone. Software
programs can then be used to analyze the transmitted data for use
by the surgeon, the Operation Room ("OR") staff, biomedical
researchers, or others, such as in a manner as described in
accordance with the teachings of U.S. patent application Ser. No.
13/276,725, the disclosure of which is incorporated by reference
herein.
[0082] Sensor (20) may comprise, for example, a piezoelectric
accelerometer, a gyroscope, a pressure sensor, a force transducer,
and/or other suitable type of sensor as apparent to one of ordinary
skill in the art in view of the teachings herein. It should be
understood that device (10) may include more than one type of
integral sensor (20). Sensor (20) may be operable in accordance
with the teachings of U.S. patent application Ser. No. 13/276,660,
the disclosure of which is incorporated herein. For example, a
pressure sensor may be built into trigger (18) of device (10). The
pressure sensor may comprise an electronic pressure sensor, or
pressure transducer, converting pressure into an analog electrical
signal. Such pressure transducers may utilize force collectors such
as a diaphragm to measure strain or deflection due to an applied
force over a space. Force collector types may include but not be
limited to a piezoresistive strain gauge, capacitive strain gauge,
electromagnetic strain gauge, piezoelectric strain gauge, and/or
optical strain gauge. Various suitable forms that such gauges may
take will be apparent to those of ordinary skill in the art in view
of the teachings herein. Similarly, various suitable ways in which
such strain gauges may be incorporated into trigger (18) will be
apparent to those of ordinary skill in the art in view of the
teachings herein.
[0083] Sensor (20) may be disposed in any of instruments (10, 24,
101, 159) and in various locations within instruments (10, 24, 101,
159), such as in removable end effectors (16, 80, 150, 180), and/or
respective transmission assemblies (70, 102, 170), and/or handle
assemblies (60, 120, 160). Removable end effectors (16, 80, 150,
180), and/or respective transmission assemblies (70, 102, 170),
attachable to handle assemblies (60, 120, 160) are referable to as
"Apps" in the present disclosure. Sensor (20) may be disposed in,
for example, a removable App that is attachable to a handle portion
of device (10).
[0084] It should be understood that sensor (20) may take a variety
of additional or alternative forms. For instance, sensor (20) may
be operable to measure the acoustic impedance of device (10). In
addition or in the alternative, sensor (20) may be operable to
measure electrical impedance of tissue. Furthermore, sensor (20)
may comprise a displacement measuring device giving feedback on a
position of a clamp arm of end effector (16) (e.g., indicating
whether the clamp arm is in an open position, closed position, or
somewhere between). Sensor (20) may also comprise one or more
thermal sensors disposed within the clamp arm of the end effector
to register a clamp arm temperature and/or a tissue temperature.
Sensor (20) may also comprise a pressure sensor disposed in the
clamp arm of end effector (16) to measure the pressure applied to
tissue by the clamp arm and an opposing blade of end effector (16).
Sensor (20) may additionally be a combination of two or more of the
above-described sensors. For example, one or more sensors (20) may
be operable to provide information regarding both clamp force as
well as clamp arm position. Other suitable forms that sensor (20)
may take will be apparent to those of ordinary skill in the art in
view of the teachings herein.
[0085] After device (10) is used in a procedure and/or during use
of device (10) in a procedure, for example, information may be
transmitted via a wireless or wired communication to generator
(28), to a smartphone, and/or to a computer, as described above. If
transmitted via a wired connection, the connection may stem from
the used App, the handle portion of device (10), and/or generator
(28) attached to device (10). Transmitted information may be
uploaded to server (304) and be used in information transmission
system (300) as described above. In addition to information
gathered by sensor (20), such transmitted information may include
information from generator (28) relating to generator (28)
operating parameters during the surgical procedure, information
relating to the type of surgical procedure (e.g., manually inputted
by a user), and/or any other type of information as will be
apparent to one of ordinary skill in the art in view of the
teachings herein. Uploaded information may be viewable on a user
interface on a computer, for example, and may be used for data
analysis (such as analysis of electrical characteristics received
from generator (28) after a surgical procedure). FIGS. 9-12 show
examples of data and information on a user interface that users may
review and analyze after transmission of such information as
described above.
[0086] FIG. 9 shows a view of data retrieved from sensor (20) in a
used App and/or handle portion of device (10), for example. The
data in this example includes information regarding steadiness
(530), speed (532), and blade pressure (534) mapped out over an
x-value of time in seconds. The left side y-value shows units of
microns of movement per second, indicating steadiness (530) of
device (10); and the right side y-value shows units of pounds of
force, indicating blade pressure (534). As shown in FIG. 9, over
the time device (10) was used in a sample surgical procedure, the
surgeon using device (10) used a fairly constant speed (532) with
device (10), applied about two cycles of built up and reduced
pressure (534) on end effector (16) of device (10) against the
operated-upon tissue, and has a steadiness (530) that fairly
paralleled the blade pressure (534) applied against the tissue,
with steadiness (530) building when pressure (534) built and
dropping when pressure (534) dropped. Such data may be interpreted
to indicate that, as blade pressure (534) increases, the ability to
maintain steadiness (530) of device (10) decreases.
[0087] FIG. 10 shows a view of electrical characteristics data
retrieved from generator (28) after a surgical procedure, for
example, via sensor (20) and/or generator (28). The x-value on the
graphs measures time in minutes. The left side y-value measures
both power (540) measured in Watts (W) and voltage (542) measured
in Volts (V), and the right side y-value measures tissue impedance
(548) in units of Ohms (Q). Impedance correlates to an amount of
resistance to current in tissue (such that an increased impedance
reduces the flow of current). For instance, sensor (20) may be used
to sense tissue impedance. The application of trigger (18) of
device (10) is shown by line (544) at a first time around 30
seconds into the procedure. The transection of operated upon tissue
via end effector (16), for example, is shown by line (546) about 9
minutes into the procedure. FIGS. 11-12 also depict graphs
indicating an application of trigger (18), shown via line (544),
and a transection of operated upon tissue by end effector (16),
shown via line (546).
[0088] Power (540), voltage (542), and impedance (548) are fairly
consistent in the terms of use as each appears to respectively rise
and fall in respective measured units alongside similar increases
and decreases of unit measurements the other electrical
characteristics. For example, as power increases, voltage tends to
increase, and impedance tends to increase at relatively similar
rates. Thus, when an increased voltage (542) is being applied to
device (10) from, for example, generator (28), FIG. 10 appears to
indicate that a corresponding increase in impedance (548) reduces
the flow of current to the operated upon tissue. Such data might be
interpreted to indicate why tissue transaction times might be
slower in certain settings. Such data could further be interpreted
indicate the type of tissue being transected.
[0089] FIG. 11 shows a view of other electrical characteristics
data retrieved from generator (28) after a surgical procedure, for
example, via sensor (20) and/or generator (28). In particular, FIG.
11 analyses the frequency slope and current characteristics
retrieved from generator (28). The x-value on the graphs measures
time in seconds. The left side y-value depicts frequency slope
(550) measured in Hertz per Second (Hz/s), and the right side
y-value measures current (552) measured in milli-Amps (mA). Line
(544) shows that trigger (18) of device (10), for example, was
applied at about some seconds past a 2 minute mark on the graph and
the transection to the operated upon tissue by end effector (16)
occurred at about just past the 4 minute mark. Generally, when
trigger (18) was applied, current (552) dropped. Between lines
(544, 546), when current (552) dropped or decreased, frequency
slope (550) tended to rise or increase, and when current (552)
increased, frequency slope (550) tended to decrease.
[0090] FIG. 12 shows a view of other electrical characteristics
data retrieved from generator (28) after a surgical procedure, for
example, via sensor (20) and/or generator (28). In particular, FIG.
12 analyses the frequency characteristics retrieved from generator
(28). The x-value on the graphs measures time in seconds. The left
side y-value depicts frequency (560) measured in Hertz (Hz).
Similar to FIG. 11, line (544) shows that trigger (18) of device
(10), for example, was applied at about some seconds past a 2
minute mark on the graph and the transection to the operated upon
tissue by end effector (16) occurred at about just past the 4
minute mark. Generally, between the time trigger (18) was applied
and the transaction occurred via device (10), frequency (560)
dropped.
[0091] The graphs may assist a user with reviewing and analysis of
the data associated with a specific surgery on a specific patient.
Through a web interface or other type of graphical user interface,
a user may mark such data with note, such as how tired a surgeon
felt on a particular day for example, or the number of assistants
in the room for the particular, tracked surgery, as well as the
equipment available for the surgical procedure. By way of example
only, a user may annotate graphs in accordance with at least some
of the teachings of U.S. Patent Appl. Publ. No. 2011/0172687,
entitled "Telemetry Device with Software User Input Features,"
published Jul. 14, 2011, the disclosure of which is incorporated by
reference herein. A software application tool may be utilized to
further export and analysis the data to determine, for example,
what the source of a user's habits might be, and/or whether a user
tends to move a blade of an end effector, such as end effector
(16), around more than desired when transecting a high-risk area
(e.g., an area surrounded with substantially small blood vessels).
By way of example only, the data may also be used to determine if
the surgeon's diet, exercise, mental state, and/or other conditions
affect the surgeon's steadiness or overall timing of a surgical
procedure (or segment of a surgical procedure). Other suitable ways
in which the above-described types of data may be used will be
apparent to one of ordinary skill in the art in view of the
teachings herein.
[0092] VII. Exemplary Calibration Kit
[0093] FIGS. 13A-13B depict a process of using a calibration kit to
set and store outcome settings which may be applied to at least one
selected App for a device (10), for example, during a procedure.
This process may be used to learn and account for unique usage
idiosyncrasies for each surgeon, such as abnormal surgical
techniques/tendencies, to promote consistent surgical results.
Desired datable end effectors and/or shaft assemblies, described
above as Apps, are selected (600) by a user. Additionally, a
calibration kit is setup (602). The calibration kit may include,
for example, synthetic tissue models having known parameters and
characteristics, tissue such as pork belly or other suitable
testable organic and/or synthetic tissue, sample vessels from
suitable testable sources (such as, for example, a pig), and other
suitable testable parts from a testable source, as well as other
suitable testable materials that may be organic and/or synthetic.
The calibration kit includes various materials that assist to
gather data to test a surgeon's usage behavior and preferences with
a device (10), for example, on the test material before testing the
usage on a patient during a surgical procedure. Certain various
parameters may be tracked and calibrated, such as a preferred force
the surgeon desires to apply, average speeds the surgeon tends to
use, and/or other parameters as will be apparent to one of ordinary
skill in the art in view of the teachings herein. In the present
example, generator (28) provides selection between a calibration
mode and at least one surgical procedure mode.
[0094] FIG. 13A shows that a calibration mode including such
parameters to track, for example, is entered (604) on generator
(28). Each of the selected Apps are used (606) with the calibration
kit by the surgeon to establish the surgeon's personally calibrated
parameter settings. For example, a surgeon uses a selected App on
organic pig tissue that may be included in the calibration kit,
utilizing the App with device (10) to cut, transect, and seal the
pig tissue and internal vessels and retrieve usage data from the
test procedure on the pig tissue. For instance, the user may delete
data associated with unsuccessful testing on the tissue/model
provided in the kit, saving only data associated with successful
testing. In addition or in the alternative, generator (28) can
automatically adjust its own operating parameters during the
calibration process in an attempt to achieve surgical success in
the testing despite any abnormal surgical techniques/tendencies
displayed by the surgeon. The desired outcome centered on these
parameters are obtained (608) via use of the calibration kit as
well as a set of associated outcome settings or parameters. The
obtained outcome settings (610) are stored in generator (28) and
are associated with a user key. The obtained outcome settings (610)
may also include data gathered in accordance with other teachings
herein (e.g., from sensor (20)). Based on data collected during the
calibration procedure shown in FIG. 13A, generator (28) is able to
establish compensatory operating parameters to compensate for
surgeon tendencies. For instance, if the calibration process shows
that the surgeon tends to apply an abnormally high amount of force
to tissue, generator (28) may know to reduce power to avoid
unintended/adverse tissue damage. Other ways in which operating
parameters of generator (28) may be adjusted based on surgeon usage
idiosyncrasies will be apparent to one of ordinary skill in the art
in view of the teachings herein.
[0095] FIG. 13B shows steps that may be carried out after generator
(28) has been calibrated based on the particular surgeon's unique
usage idiosyncrasies. In particular, FIG. 13B shows that at least
one App is selected (612) for use in a surgical procedure by, for
example, the surgeon. The selected App is connected (614) to the
generator (28). The user key is entered (616) into a user interface
that is in communication with generator (28), such that the
calibrated settings are recalled (618) via the entry of the user
key. The calibrated settings are transmitted (620) to the selected
App, which is used (622) in a surgical procedure.
[0096] For the foregoing examples, it should be understood that the
handle assemblies and/or end effectors may be reusable,
autoclavable, and/or disposable. For instance, the foregoing end
effectors may be disposable while the handle assemblies are
reuseable and/or autoclavable. In addition, if internal power
sources are used with the foregoing handle assemblies, the internal
power sources may be rechargeable. For instance, the handle
assemblies may be recharged using a plug in recharge, by removing
and recharging the batteries, by induction, and/or by any other
method as will be apparent to one of ordinary skill in the art in
view of the teachings herein. Furthermore, alignment features or
guides may be included to aid in the alignment and coupling of the
end effectors with handle assemblies. Such guides may help prevent
damage to the end effector and/or handle assembly during the
assembly of the surgical instrument.
[0097] It should be appreciated that any patent, publication, or
other disclosure material, in whole or in part, that is said to be
incorporated by reference herein is incorporated herein only to the
extent that the incorporated material does not conflict with
existing definitions, statements, or other disclosure material set
forth in this disclosure. As such, and to the extent necessary, the
disclosure as explicitly set forth herein supersedes any
conflicting material incorporated herein by reference. Any
material, or portion thereof, that is said to be incorporated by
reference herein, but which conflicts with existing definitions,
statements, or other disclosure material set forth herein will only
be incorporated to the extent that no conflict arises between that
incorporated material and the existing disclosure material.
[0098] Embodiments of the present invention have application in
conventional endoscopic and open surgical instrumentation as well
as application in robotic-assisted surgery. For instance, those of
ordinary skill in the art will recognize that various teaching
herein may be readily combined with various teachings of U.S. Pat.
No. 6,783,524, entitled "Robotic Surgical Tool with Ultrasound
Cauterizing and Cutting Instrument," issued Aug. 31, 2004, the
disclosure of which is incorporated by reference herein.
[0099] By way of example only, embodiments described herein may be
processed before surgery. First, a new or used instrument may be
obtained and if necessary cleaned. The instrument may then be
sterilized. In one sterilization technique, the instrument is
placed in a closed and sealed container, such as a plastic or TYVEK
bag. The container and instrument may then be placed in a field of
radiation that can penetrate the container, such as gamma
radiation, x-rays, or high-energy electrons. The radiation may kill
bacteria on the instrument and in the container. The sterilized
instrument may then be stored in the sterile container. The sealed
container may keep the instrument sterile until it is opened in a
medical facility. A device may also be sterilized using any other
technique known in the art, including but not limited to beta or
gamma radiation, ethylene oxide, or steam.
[0100] Embodiments of the devices disclosed herein can be
reconditioned for reuse after at least one use. Reconditioning may
include any combination of the steps of disassembly of the device,
followed by cleaning or replacement of particular pieces, and
subsequent reassembly. In particular, embodiments of the devices
disclosed herein may be disassembled, and any number of the
particular pieces or parts of the devices may be selectively
replaced or removed in any combination. Upon cleaning and/or
replacement of particular parts, embodiments of the devices may be
reassembled for subsequent use either at a reconditioning facility,
or by a surgical team immediately prior to a surgical procedure.
Those skilled in the art will appreciate that reconditioning of a
device may utilize a variety of techniques for disassembly,
cleaning/replacement, and reassembly. Use of such techniques, and
the resulting reconditioned device, are all within the scope of the
present application.
[0101] Having shown and described various embodiments of the
present invention, further adaptations of the methods and systems
described herein may be accomplished by appropriate modifications
by one of ordinary skill in the art without departing from the
scope of the present invention. Several of such potential
modifications have been mentioned, and others will be apparent to
those skilled in the art. For instance, the examples, embodiments,
geometrics, materials, dimensions, ratios, steps, and the like
discussed above are illustrative and are not required. Accordingly,
the scope of the present invention should be considered in terms of
the following claims and is understood not to be limited to the
details of structure and operation shown and described in the
specification and drawings.
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