U.S. patent application number 14/694751 was filed with the patent office on 2017-12-28 for battery-powered hand-held ultrasonic surgical cautery cutting device.
The applicant listed for this patent is Covidien AG. Invention is credited to Thomas O. Bales, Derek Dee Deville, Matthew A. Palmer, Kevin W. Smith.
Application Number | 20170367726 14/694751 |
Document ID | / |
Family ID | 44658541 |
Filed Date | 2017-12-28 |
United States Patent
Application |
20170367726 |
Kind Code |
A9 |
Smith; Kevin W. ; et
al. |
December 28, 2017 |
BATTERY-POWERED HAND-HELD ULTRASONIC SURGICAL CAUTERY CUTTING
DEVICE
Abstract
A battery-powered, modular surgical device includes an
electrically powered surgical instrument operable to surgically
interface with human tissue and a handle assembly connected to the
surgical instrument. The handle assembly has a removable hand grip
and a handle body. The hand grip is shaped to permit handling of
the surgical device by one hand of an operator, has an upper
portion and a cordless internal battery assembly that powers the
surgical instrument. The internal battery assembly has at least one
energy storage cell. The handle body is operable to removably
connect at least the upper portion of the hand grip thereto and
create an aseptic seal around at least a portion of the hand grip
when connected thereto and electrically couple the internal battery
assembly of the hand grip to the surgical instrument and thereby
power the surgical instrument for interfacing surgically with the
human tissue.
Inventors: |
Smith; Kevin W.; (Coral
Gables, FL) ; Bales; Thomas O.; (Coral Gables,
FL) ; Palmer; Matthew A.; (Miami, FL) ;
Deville; Derek Dee; (Coral Gables, FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Covidien AG |
NEUHAUSEN am RHEINFALL |
|
CH |
|
|
Prior
Publication: |
|
Document Identifier |
Publication Date |
|
US 20150265307 A1 |
September 24, 2015 |
|
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Family ID: |
44658541 |
Appl. No.: |
14/694751 |
Filed: |
April 23, 2015 |
Related U.S. Patent Documents
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Application
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Filing Date |
Patent Number |
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13215971 |
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9017355 |
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Jan 9, 2008 |
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Aug 26, 2009 |
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Apr 29, 2008 |
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60991829 |
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61019888 |
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61019888 |
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61019888 |
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61048809 |
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61048809 |
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61048809 |
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61081885 |
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61048809 |
Apr 29, 2008 |
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61045475 |
Apr 16, 2008 |
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61019888 |
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60992498 |
Dec 5, 2007 |
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60991829 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/320094
20170801; A61B 2017/320071 20170801; A61B 2017/320089 20170801;
A61B 17/320092 20130101; A61B 2017/320097 20170801; A61B 2017/00734
20130101; A61B 2017/00353 20130101 |
International
Class: |
A61B 17/32 20060101
A61B017/32 |
Claims
1-16. (canceled)
17. A surgical device, comprising: a shaft having a distal end and
a proximal end; a surgical end effector disposed at the distal end
of the shaft; a body disposed at the proximal end of the shaft, the
body defining a dock including at least one electrical contact; and
a battery assembly releasably engagable with the dock via a
non-threaded mating connection, wherein engagement of the battery
assembly with the dock establishes an aseptic seal between the
battery assembly and the body that inhibits ingress of
contamination between the battery assembly and the body, the
battery assembly including at least one battery cell and at least
one electrical contact, wherein the at least one electrical contact
of the battery assembly is electrically coupled with the at least
one electrical contact of the dock upon engagement of the battery
assembly with the dock.
18. The surgical device according to claim 17, wherein, when the
battery assembly is engaged with the dock, the battery assembly
extends from the body to define a hand grip.
19. The surgical device according to claim 18, wherein the body
further includes a trigger supported thereon and operably coupled
to the end effector assembly, the trigger movable from a
spaced-apart position relative to the hand grip to an approximated
position relative to the hand grip for manipulating the end
effector assembly.
20. The surgical device according to claim 19, wherein the trigger
and hand grip are positioned to permit single-handed grasping and
operation thereof by a user.
21. The surgical device according to claim 17, wherein the battery
assembly further includes an outer shell housing the at least one
battery cell therein.
22. The surgical device according to claim 17, further including a
generator operably coupled to the at least one contact of the body
such that the generator is capable of receiving power from the at
least one battery cell of the battery assembly.
23. The surgical device according to claim 22, wherein the
generator is an ultrasonic generator, the ultrasonic generator
configured to produce ultrasonic energy for treating tissue
adjacent the end effector assembly.
24. The surgical device according to claim 23, wherein the end
effector assembly is configured to at least one of cauterize or cut
tissue.
25. The surgical device according to claim 17, wherein the at least
one battery cell of the battery assembly is rechargeable.
26. The surgical device according to claim 17, wherein the at least
one electrical contact of the battery assembly is a spring
contact.
27. A surgical device, comprising: a shaft having a distal end and
a proximal end; a surgical end effector disposed at the distal end
of the shaft; a body disposed at the proximal end of the shaft, the
body including a first pivot component and defining a dock
including at least one electrical contact, and a battery assembly
releasably engagable with the dock, the battery assembly including
a second pivot component configured to cooperate with the first
pivot component to define a pivot axis about which the battery
assembly is rotated to engage the battery assembly with the dock,
wherein engagement of the battery assembly with the dock
establishes an aseptic seal between the battery assembly and the
body that inhibits ingress of contamination between the battery
assembly and the body, the battery assembly including at least one
battery cell and at least one electrical contact, wherein the at
least one electrical contact of the battery assembly is
electrically coupled with the at least one electrical contact of
the dock upon engagement of the battery assembly with the dock.
28. The surgical device according to claim 27, wherein, when the
battery assembly is engaged with the dock, the battery assembly
extends from the body to define a hand grip.
29. The surgical device according to claim 28, wherein the body
further includes a trigger supported thereon and operably coupled
to the end effector assembly, the trigger movable from a
spaced-apart position relative to the hand grip to an approximated
position relative to the hand grip for manipulating the end
effector assembly.
30. The surgical device according to claim 29, wherein the trigger
and hand grip are positioned to permit single-handed grasping and
operation thereof by a user.
31. The surgical device according to claim 27, wherein the battery
assembly further includes an outer shell housing the at least one
battery cell therein.
32. The surgical device according to claim 27, further including a
generator operably coupled to the at least one contact of the body
such that the generator is capable of receiving power from the at
least one battery cell of the battery assembly.
33. The surgical device according to claim 32, wherein the
generator is an ultrasonic generator, the ultrasonic generator
configured to produce ultrasonic energy for treating tissue
adjacent the end effector assembly.
34. The surgical device according to claim 33, wherein the end
effector assembly is configured to at least one of cauterize or cut
tissue.
35. The surgical device according to claim 27, wherein the at least
one battery cell of the battery assembly is rechargeable.
36. The surgical device according to claim 27, wherein one of the
first and second pivot components is a receiver and the other of
the first and second pivot components is a catch.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation application of U.S.
patent application Ser. No. 13/215,971, filed on Aug. 23, 2011,
which:
claims the priority, under 35 U.S.C. .sctn.119, of U.S. Provisional
Patent Application Ser. No. 61/376,983, filed Aug. 25, 2010; is a
continuation-in-part of U.S. patent application Ser. No.
12/266,101, filed on Nov. 6, 2008; Ser. No. 12/266,146, filed on
Nov. 6, 2008; Ser. No. 12/266,226, filed on Nov. 6, 2008; Ser. No.
12/266,252, filed on Nov. 6, 2008; Ser. No. 12/266,320, filed on
Nov. 6, 2008; Ser. No. 12/266,664, filed on Nov. 7, 2008; Ser. No.
12/269,544, filed on Nov. 12, 2008; Ser. No. 12/269,629, filed on
Nov. 12, 2008; and Ser. No. 12/270,146, filed on Nov. 13, 2008,
(which applications each claim priority to U.S. Provisional
Application Ser. Nos. 60/991,829, filed on Dec. 3, 2007;
60/992,498, filed on Dec. 5, 2007; 61/019,888, filed on Jan. 9,
2008; 61/045,475, filed on Apr. 16, 2008; 61/048,809, filed on Apr.
29, 2008; and 61/081,885, filed on Jul. 18, 2008); is a
continuation-in-part of U.S. patent application Ser. Nos.
13/022,707 and 13/022,743, filed on Feb. 8, 2011; is a
continuation-in-part of U.S. patent application Ser. No.
12/547,898, filed on Aug. 26, 2009; Ser. No. 12/547,975, filed on
Aug. 26, 2009; Ser. No. 12/547,999, filed on Aug. 26, 2009; Ser.
No. 13/072,187, filed on Mar. 25, 2011; Ser. No. 13/072,247, filed
on Mar. 25, 2011; Ser. No. 13/072,273, filed on Mar. 25, 2011; Ser.
No. 13/072,221, filed on Mar. 25, 2011; Ser. No. 13/072,309, filed
on Mar. 25, 2011; Ser. No. 13/072,345, filed on Mar. 25, 2011; Ser.
No. 13/072,373, filed on Mar. 25, 2011; and is a
continuation-in-part of U.S. patent application Ser. Nos.
12/868,505 and 12/868,545 filed Aug. 25, 2010 (which applications
claim priority to U.S. Provisional Application Ser. No. 61/236,934,
filed on Aug. 26, 2009), the entire disclosures of which are all
hereby incorporated by reference in their entireties.
BACKGROUND
[0002] 1. Field
[0003] The present invention relates generally to an ultrasonic
cutting device and, more particularly, relates to a
battery-powered, hand-held, ultrasonic surgical cautery cutting
device.
[0004] 2. Description of the Related Art
[0005] Ultrasonic instruments are effectively used in the treatment
of many medical conditions, such as removal of tissue and
cauterization of vessels. Cutting instruments that utilize
ultrasonic waves generate vibrations with an ultrasonic transducer
along a longitudinal axis of a cutting blade. By placing a resonant
wave along the length of the blade, high-speed longitudinal
mechanical movement is produced at the end of the blade. These
instruments are advantageous because the mechanical vibrations
transmitted to the end of the blade are very effective at cutting
organic tissue and, simultaneously, coagulate the tissue using the
heat energy produced by the ultrasonic frequencies. Such
instruments are particularly well suited for use in minimally
invasive procedures, such as endoscopic or laparoscopic procedures,
where the blade is passed through a trocar to reach the surgical
site.
[0006] For each kind of cutting blade (e.g., length, material,
size), there are one or more (periodic) driving signals that
produce a resonance along the length of the blade. Resonance
results in movement of the blade tip, which can be optimized for
improved performance during surgical procedures. However, producing
an effective cutting-blade driving signal is not a trivial task.
For instance, the frequency, current, and voltage applied to the
cutting tool must all be controlled dynamically, as these
parameters change with the varying load placed on the blade and
with temperature differentials that result from use of the
tool.
[0007] FIG. 1 shows a block schematic diagram of a prior-art
circuit used for applying ultrasonic mechanical movements to an end
effector. The circuit includes a power source 102, a control
circuit 104, a drive circuit 106, a matching circuit 108, a
transducer 110, and also includes a handpiece 112, and a waveguide
114 secured to the handpiece 112 (diagrammatically illustrated by a
dashed line) and supported by a cannula 120. The waveguide 114
terminates to a blade 116 at a distal end. A clamping mechanism
118, is part of the overall end effector and exposes and enables
the blade portion 116 of the waveguide 114 to make contact with
tissue and other substances. Commonly, the clamping mechanism 118
is a pivoting arm that acts to grasp or clamp onto tissue between
the arm and the blade 116. However, in some devices, the clamping
mechanism 118 is not present.
[0008] The drive circuit 106 produces a high-voltage
self-oscillating signal. The high-voltage output of the drive
circuit 106 is fed to the matching circuit 108, which contains
signal-smoothing components that, in turn, produce a driving signal
(wave) that is fed to the transducer 110. The oscillating input to
the transducer 110 causes the mechanical portion of the transducer
110 to move back and forth at a magnitude and frequency that sets
up a resonance along the waveguide 114. For optimal resonance and
longevity of the resonating instrument and its components, the
driving signal applied to the transducer 110 should be as smooth a
sine wave as can practically be achieved. For this reason, the
matching circuit 108, the transducer 110, and the waveguide 114 are
selected to work in conjunction with one another and are all
frequency sensitive with and to each other.
[0009] Because a relatively high-voltage (e.g., 100 V or more) is
required to drive a typical piezoelectric transducer 110, the power
source that is available and is used in all prior-art ultrasonic
cutting devices is an electric mains (e.g., a wall outlet) of,
typically, up to 15 A, 120 VAC. Therefore, all known ultrasonic
surgical cutting devices resemble that shown in FIGS. 1 and 2 and
utilize a countertop box 202 with an electrical cord 204 to be
plugged into the electrical mains 206 for supply of power.
Resonance is maintained by a phase locked loop (PLL), which creates
a closed loop between the output of the matching circuit 108 and
the drive circuit 106. For this reason, in prior art devices, the
countertop box 202 always has contained all of the drive and
control electronics 104, 106 and the matching circuit(s) 108. A
typical retail price for such boxes is in the tens of thousands of
dollars.
[0010] A supply cord 208 delivers a sinusoidal waveform from the
box 202 to the transducer 110 within the handpiece 112 and,
thereby, to the waveguide 114. The prior art devices present a
great disadvantage because the cord 208 has a length, size, and
weight that restricts the mobility of the operator. The cord 208
creates a tether for the operator and presents an obstacle for the
operator and those around him/her during any surgical procedure
using the handpiece 112. In addition, the cord must be shielded and
durable and is very expensive.
[0011] Another disadvantage exists in the prior art due to the
frequency sensitivity of the matching circuit 108, the transducer
110, and the waveguide 114. By having a phase-locked-loop feedback
circuit between the output of the matching circuit 108 and the
drive circuit 104, the matching circuit 108 has always been located
in the box 202, near the drive circuit 108, and separated from the
transducer 110 by the length of the supply cord 208. This
architecture introduces transmission losses and electrical
parasitics, which are common products of ultrasonic-frequency
transmissions.
[0012] In addition, prior-art devices attempt to maintain resonance
at varying waveguide 114 load conditions by monitoring and
maintaining a constant current applied to the transducer (when
operating with series resonance). However, without knowing the
specific load conditions, the only predictable relationship between
current applied to the transducer 110 and amplitude is at
resonance. Therefore, with constant current, the amplitude of the
wave along the waveguide 114 is not constant across all
frequencies. When prior art devices are under load, therefore,
operation of the waveguide 114 is not guaranteed to be at resonance
and, because only the current is being monitored and held constant,
the amount of movement on the waveguide 114 can vary greatly. For
this reason, maintaining constant current is not an effective way
of maintaining a constant movement of the waveguide 114.
[0013] Furthermore, in the prior art, handpieces 112 and
transducers 110 are replaced after a finite number of uses, but the
box 202, which is vastly more expensive than the handpiece 112, is
not replaced. As such, introduction of new, replacement handpieces
112 and transducers 110 frequently causes a mismatch between the
frequency-sensitive components (108, 110, and 112), thereby
disadvantageously altering the frequency introduced to the
waveguide 114. The only way to avoid such mismatches is for the
prior-art circuits to restrict themselves to precise frequencies.
This precision brings with it a significant increase in cost.
[0014] Therefore, a need exists to overcome the problems associated
with the prior art, for example, those discussed above.
SUMMARY
[0015] Briefly, in accordance with exemplary embodiments, the
present invention includes a battery powered device that produces
high frequency mechanical motion at the end of a waveguide for
performing useful work, specifically, to cut and seal tissue during
surgery. A piezoelectric transducer is used to convert electrical
energy into the mechanical energy that produces the motion at the
end of the waveguide. Particularly, when the transducer and
waveguide are driven at their composite resonant frequency, a large
amount of mechanical motion is produced. The circuit components of
the present invention include, among others, a battery power
supply, a control circuit, a drive circuit, and a matching
circuit--all located within a handpiece of the ultrasonic cutting
device and all operating and generating waveforms from battery
voltages. The components are selected to convert electrical energy
from the battery power supply into a high voltage AC waveform that
drives the transducer. Ideally, the frequency of this waveform is
substantially the same as the resonant frequency of the waveguide
and transducer. The magnitude of the waveform is selected to be a
value that produces the desired amount of mechanical motion.
[0016] Advantageously, the present invention, according to several
embodiments, allows components of the device to be removed,
replaced, serviced, and/or interchanged. Some components are
"disposable," which, as used herein, means that the component is
used for only one procedure and is then discarded. Still other
components are "reusable," which, as used herein, means that the
component can be sterilized according to standard medical
procedures and then used for at least a second time. As will be
explained, other components are provided with intelligence that
allows them to recognize the device to which they are attached and
to alter their function or performance depending on several
factors.
[0017] The invention provides a cordless hand-held ultrasonic
cautery cutting device that overcomes the hereinafore-mentioned
disadvantages of the heretofore-known devices and methods of this
general type and that require disposal of and prevent advantageous
reuse of costly components.
[0018] With the foregoing and other objects in view, there is
provided, in accordance with the invention, a battery-powered,
modular surgical device includes an electrically powered surgical
instrument operable to surgically interface with human tissue and a
handle assembly connected to the surgical instrument. The handle
assembly has a removable hand grip and a handle body. The hand grip
is shaped to permit handling of the surgical device by one hand of
an operator, has an upper portion and a cordless internal battery
assembly that powers the surgical instrument. The internal battery
assembly has at least one energy storage cell. The handle body is
operable to removably connect at least the upper portion of the
hand grip thereto and create an aseptic seal around at least a
portion of the hand grip when connected thereto and electrically
couple the internal battery assembly of the hand grip to the
surgical instrument and thereby power the surgical instrument for
interfacing surgically with the human tissue.
[0019] With the objects of the invention in view, there is also
provided a battery-powered, modular surgical device comprising an
electrically powered surgical end effector assembly operable to
surgically interface with human tissue and a removable hand grip
shaped to permit handling of the surgical device by one hand of an
operator. The removable hand grip includes at least one reusable
battery electrically coupled to the surgical end effector assembly
to power and thereby cause the surgical end effector assembly to
operate and is removably secured to the surgical end effector
assembly such that the at least one battery is selectively exposed
to the surgical environment when removed therefrom.
[0020] With the objects of the invention in view, there is also
provided a removable battery assembly of a battery-powered surgical
device having an electrically powered surgical instrument operable
to surgically interface with human tissue comprise a battery body
outer shell having an upper portion, a lower portion, and defining
a shell interior. The battery body outer shell is a hand grip of
the surgical device when secured to the surgical instrument, is
shaped to permit handling of the surgical device by one hand of an
operator, has, in the shell interior, a cordless rechargeable
battery that powers the surgical instrument, has an upper portion
shaped to removably connect to a portion of the surgical instrument
and create an aseptic seal around at least a part of the upper
portion when connected thereto and be selectively exposed to the
surgical environment when removed therefrom, and has exterior
conductors electrically coupled to the cordless rechargeable
battery and positioned to supply at least power to operate the
surgical instrument.
[0021] In accordance with another feature of the invention, at
least one of the surgical instrument, the removable hand grip, and
the handle body is disposable.
[0022] In accordance with a further feature of the invention, the
surgical instrument is comprised of a surgical cautery and cutting
end effector assembly.
[0023] In accordance with an added feature of the invention, the
surgical cautery and cutting end effector assembly is an ultrasonic
surgical cautery and cutting end effector assembly.
[0024] In accordance with an additional feature of the invention,
the battery assembly is rechargeable.
[0025] In accordance with yet another feature of the invention, the
at least one energy storage cell is a Lithium-based battery
cell.
[0026] In accordance with a concomitant feature of the invention,
the surgical instrument is comprised of at least one pivoting jaw
member and a cutting blade opposing the jaw member.
[0027] Although the invention is illustrated and described herein
as embodied in a cordless, battery-powered, hand-held, ultrasonic,
surgical, cautery cutting device, it is, nevertheless, not intended
to be limited to the details shown because various modifications
and structural changes may be made therein without departing from
the spirit of the invention and within the scope and range of
equivalents of the claims. Additionally, well-known elements of
exemplary embodiments of the invention will not be described in
detail or will be omitted so as not to obscure the relevant details
of the invention.
[0028] While the specification concludes with claims defining the
features of the invention that are regarded as novel, it is
believed that the invention will be better understood from a
consideration of the following description in conjunction with the
drawing figures, in which like reference numerals are carried
forward. Accordingly, the apparatus components and method steps
have been represented where appropriate by conventional symbols in
the drawings, showing only those specific details that are
pertinent to understanding the embodiments of the present invention
so as not to obscure the disclosure with details that will be
readily apparent to those of ordinary skill in the art having the
benefit of the description herein. The figures of the drawings are
not drawn to scale.
[0029] Other features that are considered as characteristic for the
invention are set forth in the appended claims. As required,
detailed embodiments of the present invention are disclosed herein;
however, it is to be understood that the disclosed embodiments are
merely exemplary of the invention, which can be embodied in various
forms. Therefore, specific structural and functional details
disclosed herein are not to be interpreted as limiting, but merely
as a basis for the claims and as a representative basis for
teaching one of ordinary skill in the art to variously employ the
present invention in virtually any appropriately detailed
structure. Further, the terms and phrases used herein are not
intended to be limiting; but rather, to provide an understandable
description of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0030] The accompanying figures, where like reference numerals
refer to identical or functionally similar elements throughout the
separate views and which together with the detailed description
below are incorporated in and form part of the specification, serve
to further illustrate various embodiments and to explain various
principles and advantages all in accordance with the present
invention.
[0031] FIG. 1 is a diagrammatic illustration of components of a
prior-art ultrasonic cutting device with separate power, control,
drive and matching components in block diagram form.
[0032] FIG. 2 is a diagram illustrating the prior-art ultrasonic
cutting device of FIG. 1.
[0033] FIG. 3 is an elevational view of a left side of an
ultrasonic surgical cautery assembly in accordance with an
exemplary embodiment of the present invention.
[0034] FIG. 4 is a perspective view from above a corner of a
battery assembly in accordance with an exemplary embodiment of the
present invention.
[0035] FIG. 5 is an elevational left side view of a transducer and
generator assembly in accordance with an exemplary embodiment of
the present invention.
[0036] FIG. 6 is a schematic block diagram of the cordless,
battery-powered, hand-held, ultrasonic, surgical, cautery cutting
device in accordance with an exemplary embodiment of the present
invention.
[0037] FIG. 7 is a schematic block diagram of a battery assembly of
the device of FIGS. 3 and 4 in accordance with an exemplary
embodiment of the present invention.
[0038] FIG. 8 is a schematic block diagram of a handle assembly of
the device of FIGS. 3 and 4 in accordance with an exemplary
embodiment of the present invention.
[0039] FIG. 9 is a schematic block diagram of the transducer and
generator assembly of the device of FIGS. 3 to 5 in accordance with
an exemplary embodiment of the present invention.
[0040] FIG. 10 is a schematic block diagram of the generator of
FIG. 9 in accordance with an exemplary embodiment of the present
invention.
[0041] FIG. 11 is a schematic block diagram of the battery
controller of the device of FIGS. 3 and 4 in accordance with an
exemplary embodiment of the present invention.
[0042] FIG. 12 is a schematic block diagram illustrating an
electrical communicating relationship between the battery assembly
and the transducer and generator assembly of the device of FIGS. 3
to 5 in accordance with an exemplary embodiment of the present
invention.
[0043] FIG. 13 is graph illustrating a square waveform input to a
matching circuit in accordance with an exemplary embodiment of the
present invention.
[0044] FIG. 14 is graph illustrating a sinusoidal waveform output
from a matching circuit in accordance with an exemplary embodiment
of the present invention.
[0045] FIG. 15 is a diagrammatic illustration of the affect that a
resonant sine wave input to a transducer has on a waveguide of the
ultrasonic cutting device in accordance with an exemplary
embodiment of the present invention with the sinusoidal pattern
shown representing the amplitude of axial motion along the length
of the waveguide.
[0046] FIG. 16 is a fragmentary, schematic circuit diagram of an
elemental series circuit model for a transducer in accordance with
an exemplary embodiment of the present invention.
[0047] FIG. 17 is a fragmentary, schematic circuit diagram of an
inventive circuit with the circuit of FIG. 16 and is useful for
monitoring a motional current of a transducer in accordance with an
exemplary embodiment of the present invention.
[0048] FIG. 18 is a fragmentary, schematic circuit diagram of an
elemental parallel circuit model of a transducer in accordance with
an exemplary embodiment of the present invention.
[0049] FIG. 19 is fragmentary, schematic circuit diagram of an
inventive circuit with the circuit of FIG. 20 and is useful for
monitoring the motional current of a transducer in accordance with
an exemplary embodiment of the present invention.
[0050] FIG. 20 is a fragmentary, schematic circuit diagram of an
inventive circuit with the circuit of FIG. 16 and is useful for
monitoring the motional current of a transducer in accordance with
an exemplary embodiment of the present invention.
[0051] FIG. 21 is a fragmentary, schematic circuit diagram of an
inventive circuit with the circuit of FIG. 18 and is useful for
monitoring the motional voltage of a transducer in accordance with
an exemplary embodiment of the present invention.
[0052] FIG. 22 is a schematic circuit diagram modeling a direct
digital synthesis technique implemented in accordance with an
exemplary embodiment of the present invention.
[0053] FIG. 23 is a graph illustrating an exemplary direct output
of a digital-to-analog converter (DAC) positioned above a filtered
output of the DAC in accordance with an exemplary embodiment of the
present invention.
[0054] FIG. 24 is a graph illustrating an exemplary direct output
of a digital-to-analog converter (DAC) with a tuning word shorter
than the tuning word used to produce the graph of FIG. 23
positioned above a filtered output of the DAC using the same
shortened tuning word in accordance with an exemplary embodiment of
the present invention.
[0055] FIG. 25 is a graph illustrating an exemplary direct output
of a digital-to-analog converter (DAC) with a tuning word longer
than the tuning word used to produce the graph of FIG. 23
positioned above a filtered output of the DAC using the longer
tuning word in accordance with an exemplary embodiment of the
present invention.
[0056] FIG. 26 is block circuit diagram of exemplary components
comprising the current control loop in accordance with an exemplary
embodiment of the present invention.
[0057] FIG. 27 is a block circuit diagram of the device of FIG. 3
in accordance with an exemplary embodiment of the present
invention.
[0058] FIG. 28 is a perspective view from above the front of the
battery assembly of FIG. 4 in accordance with an exemplary
embodiment of the present invention.
[0059] FIG. 29 is a fragmentary, perspective view from a left side
of the of the battery assembly of FIG. 4 with one half of the shell
removed exposing an underside of a multi-lead battery terminal and
an interior of the remaining shell half in accordance with an
exemplary embodiment of the present invention.
[0060] FIG. 30 is a fragmentary, perspective view from a right side
of the battery assembly of FIG. 4 with one half of the shell
removed exposing the circuit board connected to the multi-lead
battery terminal in accordance with an exemplary embodiment of the
present invention.
[0061] FIG. 31 is an elevated perspective view of the battery
assembly of FIG. 4 with both halves of the shell removed exposing
battery cells coupled to multiple circuit boards which are coupled
to the multi-lead battery terminal in accordance with an exemplary
embodiment of the present invention.
[0062] FIG. 32 is an elevated perspective view of the battery
assembly shown in FIG. 31 with one half of the shell in place in
accordance with an exemplary embodiment of the present
invention.
[0063] FIG. 33 is an elevated perspective view of the battery
assembly of FIG. 4 showing a catch located on a rear side of the
battery assembly in accordance with an exemplary embodiment of the
present invention.
[0064] FIG. 34 is an underside perspective view of the handle
assembly of FIG. 3 exposing a multi-lead handle terminal assembly
and a receiver for mating with the battery assembly of FIG. 4 in
accordance with an exemplary embodiment of the present
invention.
[0065] FIG. 35 is a close-up underside perspective view of the
handle assembly of FIG. 3 exposing a multi-lead handle terminal
assembly and a receiver for mating with the battery assembly of
FIG. 4 in accordance with an exemplary embodiment of the present
invention.
[0066] FIG. 36 is an underside perspective view illustrating an
initial mating connection between the handle assembly and the
battery assembly in accordance with an exemplary embodiment of the
present invention.
[0067] FIG. 37 is a perspective view of the battery assembly fully
connected to the handle assembly in accordance with an exemplary
embodiment of the present invention.
[0068] FIG. 38 is a close-up perspective view of the exterior
surface of the battery assembly of FIG. 4 illustrating a release
mechanism for coupling the battery assembly to the handle assembly
in accordance with an exemplary embodiment of the present
invention.
[0069] FIG. 39 is a close-up perspective view of the multi-lead
handle terminal assembly in accordance with an exemplary embodiment
of the present invention.
[0070] FIG. 40 is a close-up perspective view of the ultrasonic
surgical cautery assembly of FIG. 1 with one half the shell of the
handle assembly removed providing a detailed view of the mating
position between the multi-lead handle terminal assembly and the
multi-lead handle battery assembly in accordance with an exemplary
embodiment of the present invention.
[0071] FIG. 41 is a fragmentary, cross-sectional and perspective
view of a pressure valve of the battery assembly of FIG. 3 in
accordance with an exemplary embodiment of the present invention
viewed from a direction inside the battery assembly.
[0072] FIG. 42 is a fragmentary, cross-sectional view of the
pressure valve of FIG. 41 viewed from a side of the valve.
[0073] FIG. 43 is a perspective view of the pressure valve of FIG.
41 separated from the battery assembly.
[0074] FIG. 44 is a graph illustrating pressure states of the
pressure valve of FIG. 41 in accordance with an exemplary
embodiment of the present invention.
[0075] FIG. 45 is an elevational exploded view of the left side of
the ultrasonic surgical cautery assembly of FIG. 3 showing the left
shell half removed from the battery assembly and the left shell
half removed from the handle assembly in accordance with an
exemplary embodiment of the present invention.
[0076] FIG. 46 is an elevational right-hand view of the handle
assembly of FIG. 3 with the right shell half removed showing
controls in accordance with an exemplary embodiment of the present
invention.
[0077] FIG. 47 is elevational close-up view of the handle assembly
of FIG. 3 with the left shell half removed showing the trigger of
FIG. 46 in accordance with an exemplary embodiment of the present
invention.
[0078] FIG. 48 is an elevational close-up view of a two-stage
switch in the handle assembly activated by the button of FIG. 46 in
accordance with an exemplary embodiment of the present
invention.
[0079] FIG. 49 is an elevational view of an example of a two-stage
switch of FIG. 48 in accordance with an exemplary embodiment of the
present invention.
[0080] FIG. 50 is an elevational side view of the TAG of FIG. 3 in
accordance with an exemplary embodiment of the present
invention.
[0081] FIG. 51 is an elevational underside view of the TAG of FIG.
50 in accordance with an exemplary embodiment of the present
invention.
[0082] FIG. 52 is an elevational upper view of the TAG of FIG. 50
in accordance with an exemplary embodiment of the present
invention.
[0083] FIG. 53 is an elevational view of the TAG of FIG. 50 with an
upper cover removed revealing generator circuitry in accordance
with an exemplary embodiment of the present invention.
[0084] FIG. 54 is an elevational underside view of the TAG of FIG.
50 with an underside cover removed revealing electrical coupling
between the generator and the transducer in accordance with an
exemplary embodiment of the present invention.
[0085] FIG. 55 is a perspective underside view of the TAG of FIG.
50 with an underside cover of the TAG removed and the transducer
cover removed revealing components of the transducer in accordance
with an exemplary embodiment of the present invention.
[0086] FIG. 56 is an elevational left side view of the handle
assembly and the TAG, illustrating a coupling alignment between the
handle assembly and the TAG in accordance with an exemplary
embodiment of the present invention.
[0087] FIG. 57 is an elevational exploded view of the left side of
the ultrasonic surgical cautery assembly of FIG. 3 showing the left
shell half removed from handle assembly exposing a device
identifier communicatively coupled to the multi-lead handle
terminal assembly in accordance with an exemplary embodiment of the
present invention.
[0088] FIG. 58 is a perspective close-up view of the transducer
with the outer shell removed in accordance with an exemplary
embodiment of the present invention.
[0089] FIG. 59 is a perspective close-up view of the coupling
relationship between the catch on the battery assembly and the
receiver on the handle assembly as well as the sealing relationship
between the multi-lead battery terminal assembly and the multi-lead
handle terminal assembly in accordance with an exemplary embodiment
of the present invention.
[0090] FIG. 60 is a perspective close-up transparent view of the
sealing gasket of FIG. 59 in accordance with an exemplary
embodiment of the present invention.
[0091] FIG. 61 is a perspective partial view of the handle assembly
with the right-hand cover half removed, exposing a
near-over-centering trigger mechanism in accordance with an
exemplary embodiment of the present invention.
[0092] FIG. 62 is a perspective partial view of the
near-over-centering trigger mechanism of FIG. 61, with the trigger
slightly depressed, in accordance with an exemplary embodiment of
the present invention.
[0093] FIG. 63 is a perspective partial view of the
near-over-centering trigger mechanism of FIG. 61, with the trigger
depressed, in accordance with an exemplary embodiment of the
present invention.
[0094] FIG. 64 is a perspective partial view of the
near-over-centering trigger mechanism of FIG. 61, with the trigger
fully depressed, in accordance with an exemplary embodiment of the
present invention.
[0095] FIG. 65 is a perspective fragmentary view of a rotational
lockout member and blade adjacent, but not engaging with, a
waveguide assembly rotation-prevention wheel, in accordance with an
exemplary embodiment of the present invention.
[0096] FIG. 66 is a perspective fragmentary view of the rotational
lockout member and blade of FIG. 65 engaging the waveguide assembly
rotation-prevention wheel in accordance with an exemplary
embodiment of the present invention.
[0097] FIG. 67 is a perspective fragmentary view of a two-stage
button in an undepressed state and in physical communication with
the rotational lockout member of FIG. 65 in accordance with an
exemplary embodiment of the present invention.
[0098] FIG. 68 is a perspective fragmentary view of the two-stage
button in a first depressed state and physically engaging the
rotational lockout member of FIG. 65 in accordance with an
exemplary embodiment of the present invention.
[0099] FIG. 69 is a perspective fragmentary view of the two-stage
button of FIG. 68 in a second depressed state and fully engaging
the rotational lockout member of FIG. 65, which, in turn, is
engaging the waveguide assembly rotation-prevention wheel in
accordance with an exemplary embodiment of the present
invention.
[0100] FIG. 70 is a perspective fragmentary view of a rotational
lockout member and dual blades adjacent, but not engaging with, a
waveguide assembly rotation-prevention wheel, in accordance with an
exemplary embodiment of the present invention.
[0101] FIG. 71 is a perspective fragmentary view of the rotational
lockout member and dual blades of FIG. 70 engaging the waveguide
assembly rotation-prevention wheel in accordance with an exemplary
embodiment of the present invention.
[0102] FIG. 72 is a process flow diagram illustrating a start-up
procedure in accordance with an exemplary embodiment of the present
invention.
[0103] FIG. 72A is a process flow diagram illustrating a portion of
the start-up procedure in accordance with an exemplary embodiment
of the present invention.
[0104] FIG. 73 is a fragmentary, enlarged perspective view of an
exemplary embodiment of an end effector according to the invention
from a distal end with a jaw in an open position;
[0105] FIG. 74 is a fragmentary, enlarged perspective view of the
end effector of FIG. 73 from below with an outer tube removed;
[0106] FIG. 75 is a fragmentary, enlarged cross-sectional and
perspective view of the end effector of FIG. 73 from below with the
section taken transverse to the jaw-operating plane through the
waveguide;
[0107] FIG. 76 is a fragmentary, enlarged side elevational view of
the end effector of FIG. 73 with the outer tube removed;
[0108] FIG. 77 is a fragmentary, enlarged cross-sectional side view
of the end effector of FIG. 73 with the section taken parallel to
the jaw-operating plane with the waveguide removed;
[0109] FIG. 78 is a fragmentary, enlarged, side elevational view of
the end effector of FIG. 73;
[0110] FIG. 79 is a fragmentary, enlarged, side elevational view of
the end effector of FIG. 78 with the jaw in a substantially closed
position;
[0111] FIG. 80 is a fragmentary, enlarged, perspective view of the
end effector of FIG. 73 with the jaw in the substantially closed
position;
[0112] FIG. 81 is a fragmentary, enlarged cross-sectional side view
of the end effector of FIG. 73 with the section taken in the
jaw-operating plane;
[0113] FIG. 82 is an enlarged perspective view of a coupling spool
of the end effector of FIG. 73;
[0114] FIG. 83 is a fragmentary, enlarged, cross-sectional view of
the end effector of FIG. 73 with the section taken orthogonal to
the longitudinal axis of the waveguide at a jaw pivot;
[0115] FIG. 84 is an enlarged, perspective view of a jaw insert of
the end effector of FIG. 73 viewed from below a distal end;
[0116] FIG. 85 is an enlarged, cross-sectional and perspective view
of a left portion of the jaw insert of FIG. 84 seated within a left
portion of the jaw of FIG. 73 viewed from below a proximal end;
[0117] FIG. 86 is a fragmentary, enlarged, perspective view of a
TAG attachment dock and a waveguide attachment dock of the handle
assembly of FIG. 46 with a right half of the handle body, a
rotation-prevention wheel, and a spring and bobbin of the jaw
force-limiting assembly removed;
[0118] FIG. 87 is a fragmentary, enlarged, perspective view of the
handle assembly of FIG. 86 with an outer tube removed and only a
right half of the rotation-prevention wheel removed; and
[0119] FIG. 88 is a perspective view of a torque wrench according
to an exemplary embodiment of the invention.
DETAILED DESCRIPTION OF THE EMBODIMENTS
[0120] It is to be understood that the disclosed embodiments are
merely exemplary of the invention, which can be embodied in various
forms. Therefore, specific structural and functional details
disclosed herein are not to be interpreted as limiting, but merely
as a basis for the claims and as a representative basis for
teaching one skilled in the art to variously employ the present
invention in virtually any appropriately detailed structure.
Further, the terms and phrases used herein are not intended to be
limiting; but rather, to provide an understandable description of
the invention.
[0121] Before the present invention is disclosed and described, it
is to be understood that the terminology used herein is for the
purpose of describing particular embodiments only and is not
intended to be limiting. In this document, the terms "a" or "an",
as used herein, are defined as one or more than one. The term
"plurality," as used herein, is defined as two or more than two.
The term "another," as used herein, is defined as at least a second
or more. The terms "including" and/or "having," as used herein, are
defined as comprising (i.e., open language). The term "coupled," as
used herein, is defined as connected, although not necessarily
directly, and not necessarily mechanically. Relational terms such
as first and second, top and bottom, and the like may be used
solely to distinguish one entity or action from another entity or
action without necessarily requiring or implying any actual such
relationship or order between such entities or actions. The terms
"comprises," "comprising," or any other variation thereof are
intended to cover a non-exclusive inclusion, such that a process,
method, article, or apparatus that comprises a list of elements
does not include only those elements but may include other elements
not expressly listed or inherent to such process, method, article,
or apparatus. An element proceeded by "comprises . . . a" does not,
without more constraints, preclude the existence of additional
identical elements in the process, method, article, or apparatus
that comprises the element.
[0122] As used herein, the term "about" or "approximately" applies
to all numeric values, whether or not explicitly indicated. These
terms generally refer to a range of numbers that one of skill in
the art would consider equivalent to the recited values (i.e.,
having the same function or result). In many instances these terms
may include numbers that are rounded to the nearest significant
figure. In this document, the term "longitudinal" should be
understood to mean in a direction corresponding to an elongated
direction of the object being described.
[0123] It will be appreciated that embodiments of the invention
described herein may be comprised of one or more conventional
processors and unique stored program instructions that control the
one or more processors to implement, in conjunction with certain
non-processor circuits and other elements, some, most, or all of
the functions of ultrasonic cutting devices described herein. The
non-processor circuits may include, but are not limited to, signal
drivers, clock circuits, power source circuits, and user input and
output elements. Alternatively, some or all functions could be
implemented by a state machine that has no stored program
instructions, or in one or more application specific integrated
circuits (ASICs) or field-programmable gate arrays (FPGA), in which
each function or some combinations of certain of the functions are
implemented as custom logic. Of course, a combination of these
approaches could also be used. Thus, methods and means for these
functions have been described herein.
[0124] The terms "program," "software application," and the like as
used herein, are defined as a sequence of instructions designed for
execution on a computer system. A "program," "computer program," or
"software application" may include a subroutine, a function, a
procedure, an object method, an object implementation, an
executable application, an applet, a servlet, a source code, an
object code, a shared library/dynamic load library and/or other
sequence of instructions designed for execution on a computer
system.
[0125] The present invention, according to one embodiment,
overcomes problems with the prior art by providing a lightweight,
hand-held, cordless, battery-powered, surgical cautery cutting
device that is powered by and controlled with components that fit
entirely within a handle of the device. The hand-held device allows
a surgeon to perform ultrasonic cutting and/or cauterizing in any
surgical procedure without the need for external power and,
particularly, without the presence of cords tethering the surgeon
to a stationary object and constricting the range of movement of
the surgeon while performing the surgical procedure.
[0126] Ultrasonic Surgical Device
[0127] Described now is an exemplary apparatus according to one
embodiment of the present invention. Referring to FIG. 3, an
exemplary cordless ultrasonic surgical cautery assembly 300 is
shown. The inventive assembly 300 can be described as including
three main component parts: (1) a battery assembly 301; (2) a
handle assembly 302 with an ultrasonic cutting blade and waveguide
assembly 304 (only a proximal portion of which is illustrated in
FIG. 3); and (3) a transducer-and-generator ("TAG") assembly 303.
The handle assembly 302 and the ultrasonic cutting blade and
waveguide assembly 304 are pre-coupled but rotationally independent
from one another. The battery assembly 301, according to one
exemplary embodiment, is a rechargeable, reusable battery pack with
regulated output. In some cases, as is explained below, the battery
assembly 301 facilitates user-interface functions. The handle
assembly 302 is a disposable unit that has bays or docks for
attachment to the battery assembly 301, the TAG assembly 303, and
the ultrasonic cutting blade and waveguide assembly 304. The handle
assembly 302 also houses various indicators including, for example,
a speaker/buzzer and activation switches.
[0128] The TAG assembly 303 is a reusable unit that produces high
frequency mechanical motion at a distal output. The TAG assembly
303 is mechanically coupled to the ultrasonic cutting blade and
waveguide assembly 304 during operation of the device and produces
movement at the distal output, i.e., the cutting blade. In one
embodiment, the TAG assembly 303 also provides a visual user
interface, such as, through a red/green/blue (RGB) LED. As such, a
visual indicator of the battery status is uniquely not located on
the battery and is, therefore, remote from the battery.
[0129] The present invention's ability to provide all of the
necessary components of an ultrasonic cutting tool in a hand-held
package provides a great advantage over prior-art devices, which
devices house substantially all of the device components within a
very expensive and heavy desktop box 202, as shown in FIG. 2, and
include an expensive tether 208 between the device's handpiece 112
and the desktop box 202, which, most significantly, is bulky and
interferes with the surgeon's movements.
[0130] In accordance with the present invention, the three
components of the handheld ultrasonic surgical cautery assembly 300
are advantageously quickly disconnectable from one or more of the
others. Each of the three components of the system is sterile and
can be maintained wholly in a sterile field during use. Because
each portion can be separated from one or more of the other
components, the present invention can be composed of one or more
portions that are single-use items (i.e., disposable) and others
that are multi-use items (i.e., sterilizable for use in multiple
surgical procedures). FIGS. 4 and 5 show the battery assembly 301
and TAG assembly 303 components, respectively, separate from the
overall composite assembly shown in FIG. 3. The details of each of
the components are shown and described throughout the remainder of
the specification. These details include, inter alia, physical
aspects of each component separate and as part of the handheld
ultrasonic surgical cautery assembly 300, electronic functionality
and capability of each component separate and as part of the
overall assembly 300, and methods of use, assembly, sterilization,
and others of each component separate and as part of the overall
assembly 300. In accordance with an additional embodiment of the
present invention, each of the components 301, 302/304, 303 is
substantially equivalent in overall weight. Each of these
components 301, 302/304, 303 is balanced so that they weigh
substantially the same. This, combined with a triangular assembly
configuration, makes the overall handheld ultrasonic surgical
cautery assembly 300 advantageously provided with a center of
balance that provides a very natural and comfortable feel to the
user operating the device. That is, when held in the hand of the
user, the overall assembly 300 does not have a tendency to tip
forward or backward or side-to-side but remains relatively and
dynamically balanced so that the waveguide is held parallel to the
ground with very little effort from the user. Of course, the
instrument can be placed in non-parallel angles to the ground just
as easily.
[0131] FIG. 6 provides a general block schematic diagram
illustrating the communicative coupling between the battery
assembly 301, the handle assembly 302, and the TAG assembly 303.
FIG. 6 also shows various power and communication signal paths
601a-n between the battery assembly 301 and the handle assembly
302. The handle assembly 302 provides additional power and
communication signal paths 602a-n that continue on to the TAG
assembly 303. These power and communication signal paths 601a-n
facilitate operation of: [0132] 1. a buzzer, e.g., audio frequency
signal, which provides an audible user interface; [0133] 2. a
minimum button, e.g., 0 to 3.3 V and 0 to 25 mA input signal, which
is a user interface to activate ultrasound output at minimum
amplitude; [0134] 3. a maximum button, e.g., 0 to 3.3 V and 0 to 25
mA, which is a user interface to activate ultrasound output at
maximum amplitude; [0135] 4. a first output voltage (Vout), e.g., 0
to 10 Volt and 0 to 6 A output, from the battery assembly 301 to
the TAG assembly 303 and provides power to the TAG assembly 303 to
generate a transducer drive signal; [0136] 5. a ground or system
common connection; [0137] 6. a second output voltage (Vbatt), which
is a voltage output from battery for providing power for the
system; [0138] 7. a first communication line (Comm+), which
provides differential half duplex serial communications between the
battery assembly 301 and the TAG assembly 303; [0139] 8. a second
communication line (Comm-), which provides differential half duplex
serial communications between the battery assembly 301 and the TAG
assembly 303; and [0140] 9. a present line, which, when connected
to the handle assembly 302, activates power in the battery assembly
301 and, thereby, to the entire system.
[0141] In accordance with an embodiment of the present invention,
the above-described power and communication signal paths 601a-n are
provided through a flex circuit that spans between a first
multi-lead handle terminal assembly on the handle assembly 302
(where the battery assembly 301 electrically couples to the handle
assembly 302) and a second multi-lead handle terminal assembly on
the handle assembly 302 (where the TAG assembly 303 electrically
couples to the handle assembly 302).
[0142] I. Battery Assembly
[0143] FIG. 7 provides a general block schematic diagram
illustrating battery assembly 301 and the internal components
included therein. The battery assembly 301 generally includes one
or more battery cells 701, a battery protection circuit 702, and a
battery controller 703. Various power and signal paths 704a-n run
between the battery cells 701 and the battery protection circuit
702. Power and communication signal paths 706a-n run between the
battery protection circuit 702 and the battery controller 703. The
power and signal paths 704a-n and 706a-n can be simple direct
connections between components or can include other circuit
elements not shown in the figures. The power and communication
signal paths 706a-n include, among others: [0144] 1. a SMBus clock
signal (SCLK), which is used for communications between the battery
controller 703 and the battery fuel gauge/protection circuit 702;
[0145] 2. a SMBus data signal (SDAT), which is used for
communications between the battery controller 703 and the battery
fuel gauge/protection circuit 702; and [0146] 3. an enable switch
that turns off the battery controller 703 when the battery assembly
301 is in a charger by removing power to the switching power supply
within the battery controller 703 once grounded.
[0147] a. Battery Cells
[0148] The battery cells 701 include, in one embodiment, a 4-cell
lithium-ion polymer (LiPoly) battery. There is, of course, no limit
to the number of cells that can be used and no requirement that the
cells be LiPoly type. Advantageously, manufacturers can produce
LiPoly batteries in almost any shape that is necessary. These types
of batteries, however, must be carefully controlled during the
charging process, as overcharging LiPoly batteries quickly causes
damages to the cells. Therefore, these batteries must be charged
carefully. For this reason, the present invention utilizes an
inventive battery protection circuit 702.
[0149] b. Battery Protection
[0150] The battery protection circuit 702 controls charging and
discharging of the battery cells 701 and provides battery
protection and "fuel gauge" functions, i.e., battery power
monitoring. More particularly, the battery protection circuit 702
provides over-voltage, under-voltage, over-temperature, and
over-current monitoring and protection during both the charging and
discharging stages. If overcharged, LiPoly batteries cannot only be
damaged but can also ignite and/or vent.
[0151] The "fuel gauge" function of the battery protection circuit
702 limits the discharge of voltage and current, both continuous
and transient, on the output of the battery assembly 301. During
charging of the battery cells 701, the fuel gauge can limit the
current level fed to the battery cells 701. Alternatively, a
battery charging unit can perform this current-limiting function.
The fuel gauge also monitors temperature and shuts down the battery
assembly 301 when a temperature of the battery cells 701 exceeds a
given temperature. The fuel gauge is further able to determine how
much total energy is left in the battery cells 701, to determine
how much previous charge has been received, to determine an
internal impedance of the battery cells 701, to determine current
and voltage being output, and more. By using this data, the present
invention, through use of inventive algorithms, is able to
determine the operational capacity of the battery cells 701 based
in part on the chemical attributes of the battery cells 701 and, in
particular, to identify when there is not enough battery capacity
to safely perform a surgical procedure as described in further
detail below.
[0152] c. Battery Controller
[0153] FIG. 11 is a general block circuit diagram illustrating the
internal components of the battery controller 703 of FIG. 7. As
previously shown in FIG. 7, the battery controller 703 is fed
signals and powered through power and communication signal paths
706a-n. Additionally, the battery controller 703 also provides
output power and signals along power and communication signal paths
601a-n. The battery controller 703, according to one exemplary
embodiment of the present invention, includes a power supply 1102,
SMBus isolation switch(es) 1104, a microcontroller 1106, an audio
driver 1108, a user buttons interface 1110, a serial communications
transceiver 1112, and a buck converter 1114.
[0154] The power supply 1102 produces various voltage levels at its
output, which are used to power the various battery controller
components shown in FIG. 11. The SMBus isolation switch(es) 1104
is/are used to disconnect the SMBus lines to the battery protection
printed circuit board during charging and when the bus is used for
other purposes within the battery controller.
[0155] Microcontroller 1106 is a highly-integrated processing unit
that controls the functions of the battery controller 703. Audio
driver 1108 produces a signal that ultimately drives the buzzer 802
that is located in the handle assembly 302. The user buttons
interface 1110 conditions the signals received from the minimum 804
and maximum 806 activation switches housed within the handle
assembly 302. The serial communications transceiver 1112 provides
transmission and reception of differential half-duplex
communications between the battery controller 703 and the generator
904. Finally, the buck converter 1114 steps down the battery
voltage to produce a lower voltage for delivery to the TAG assembly
303 for generation of the ultrasound output signal to the
transducer 902. The microcontroller controls the output of the buck
regulator by varying or modulating the pulse widths of the input
signals to the buck converter (i.e., pulse width modulation (PWM)).
The battery controller measures the impedance of the switch and
will not activate the system until the impedance detected falls
bellow a predetermined threshold. This will eliminate accidental
activations due to fluid ingress which are generally detected as
higher impedances in the switch that that of a fully closed switch.
The present line works on a similar principle, ensuring that the
present line is closed through a low enough impedance before the
battery is turned on. This is done so that exposure of the present
pin to any conducting fluid will not accidentally turn on the
battery pack.
[0156] As set forth in detail below, the battery controller 703
facilitates a user interface, e.g., a buzzer 802 and RGB LEDs 906,
and converts the output voltage and current output of the buck
converter, which output powers the TAG assembly 303 through at
least one voltage output path (V.sub.out) 601a-n.
[0157] II. Handle Assembly
[0158] FIG. 8 is a general block schematic diagram illustrating the
handle assembly 302 shown in FIG. 3. The handle assembly 302
receives control and power signals over attached power and
communication signal paths 601a-n. A second set of power and
communication signal paths 602a-n connect to the TAG assembly 303
when it is attached to the handheld ultrasonic surgical cautery
assembly 300. As is explained in detail below, the handle assembly
302 houses the ultrasonic waveguide assembly 304 and provides a
portion of the pistol grip that the operator uses to grasp and
operate the entire handheld ultrasonic surgical cautery assembly
300 using, for example, a two-stage switch of button 4608 and
trigger 4606 (as introduced in FIG. 46). The handle assembly 302,
according to one exemplary embodiment, is provided with a
speaker/buzzer 802 capable of receiving a buzzer output signal from
the battery assembly 301 through a signal path 601a-n and of
producing an audible output, e.g., 65 db, suitable for
communicating specific device conditions to an operator. These
conditions include, for example, successful coupling of assembly
components, e.g., battery assembly 301 to handle assembly 302,
high, low, or normal operation mode, fault conditions, low battery,
device overload, mechanical failure, electrical failure, and
others. The handle also includes a Min. Button switch 804 and a
Max. Button switch 806 that, when activated, connects the
respective button to ground, which signals the battery controller
to start the ultrasonic output in either low or high amplitude
mode. The handle assembly 302 also provides a pass-through
interconnect for signals between the battery assembly 301 and the
TAG assembly 303.
[0159] III. Tag
[0160] FIG. 9 is a block and schematic circuit diagram illustrating
the TAG assembly 303 of FIGS. 3 and 5, which houses the transducer
902 and the generator 904. The generator 904 converts DC power from
the battery controller 703 into a higher-voltage AC signal that
drives the transducer 902, which converts the electrical signal to
mechanical motion.
[0161] a. Generator
[0162] FIG. 10 is a block circuit diagram illustrating the internal
components of the generator 904. The generator 904, according to an
exemplary embodiment of the present invention, includes a power
supply 1002, a serial communications transceiver 1004, a
microcontroller 1006, a numerically controlled oscillator (NCO)
1008, a push/pull switching amplifier 1010, an output
filter/matching network 1012, a motional bridge 1014, a feedback
amplifier and buffer(s) 1016, an LED driver 1018, and indicators
906, for example, RGB LEDs. The power supply 1002 receives power
from the battery assembly 301 through lines Vbatt and GND of the
power signal paths 602a-n and outputs various voltages that are
used to power the generator 904. The serial communications
transceiver 1004 provides transmission and reception communications
between the battery controller 703 and the generator 904, here,
through a serial data link Comm+/Comm- of the communication signal
paths 602a-n, although this communication can occur through a
single line or through a number of lines, in series or in
parallel.
[0163] The microcontroller 1006 is a highly integrated processing
unit that controls the functions of the generator 904 and is one of
two microcontrollers in the system, the other being part of the
battery controller 703. In the exemplary embodiment, a serial data
link (Comm+, Comm-) exists between the two microcontrollers 1006,
1106 so they can communicate and coordinate their operation. The
microcontroller 1006 in the TAG 303 controls generation of the
high-voltage waveform driving the piezoelectric transducer 902. The
microcontroller 1006 in the battery assembly 301 controls
conversion of the DC voltage from the battery cells 701 to a lower
DC voltage used by the TAG 303 when generating the high voltage AC
to the transducer 902. The battery microcontroller 1106 regulates
the DC output of the battery assembly 301 to control the amplitude
of the mechanical motion, and the TAG microcontroller 1006 controls
the frequency of the signal that drives the transducer 902. The
battery microcontroller 1106 also handles the user interface, and
the battery protection circuit 702 monitors the battery cells 701
during system operation.
[0164] Direct digital synthesis (DDS) is a technique used to
generate a periodic waveform with a precise output frequency that
can be changed digitally using a fixed frequency source. The NCO
1008 is a signal source that uses the DDS technique, which can be
performed through hardware or software. The fixed frequency input
to the DDS is used to generate a clock for the NCO 1008. The output
is a series of values that produce a time-varying periodic
waveform. A new output value is generated during each clock
cycle.
[0165] The DDS 2200, which is shown in detail in FIG. 22, works by
calculating the phase component of the output waveform that is then
converted to amplitude, with a new phase value being generated each
clock cycle. The phase value is stored in a variable register 2202,
which register is referred to herein as the "phase accumulator."
During each clock cycle, a fixed number is added to the number
stored in the phase accumulator to produce a new phase value. This
fixed number is often referred to as the frequency control word or
frequency tuning word because it, along with the clock frequency,
determines the output frequency. The value in the phase accumulator
spans one cycle of the periodic output waveform from 0 to 360
degrees, with the value rolling over at 360 degrees.
[0166] The value in the phase accumulator is fed into a
phase-to-amplitude converter 2204. For a sine wave, the amplitude
can be computed using the arctangent of the phase value. For high
speed applications, the converter usually uses a lookup table to
generate the amplitude value from the phase value.
[0167] In a hardware implementation of DDS, the output of the
amplitude converter is input to a digital-to-analog converter (DAC)
2206 to generate an analog output signal f.sub.out. The analog
signal is usually filtered by a band pass or low pass filter to
reduce unwanted frequency components in the output waveform.
[0168] As a first example, the value in the phase accumulator 2202
can be set to an integer from 0 to 359. If the frequency tuning
word is 1, the value in the phase accumulator 2202 will be
incremented by 1 each clock cycle. When the value reaches 359, it
rolls over to zero. If the clock frequency is 360 Hz, the frequency
of the output waveform will be 1 Hz. The output will therefore be a
series of 360 points during each 1 second period of the output
waveform. If the frequency tuning word is changed to 10, the value
in the phase accumulator is incremented by 10 each clock cycle, and
the output frequency will be 10 Hz. The output will therefore be 36
points for each period of the output waveform. If the frequency
tuning word is 100, the output frequency will be 100 Hz. In that
case, there will be 3.6 points for each output period. Or, more
accurately, some cycles of the output waveform will have 3 points
and some will have 4 points. The ratio of cycles with 4 points
versus 3 points is 0.6.
[0169] As a second example, the value in the phase accumulator 2202
can be a 10 bit number. The 10 bit number will have 1024 possible
values. With a frequency tuning word of 50 and a clock frequency of
1 MHz, the output frequency will be 50*1 MHz/1024=48.828 kHz. FIG.
23 illustrates the output 2300 of the DAC 2206 and what the
filtered DAC output might look like.
[0170] If the frequency tuning word is 22, the output frequency is
22*1 MHz/1024=21.484 kHz. In this case, FIG. 24 illustrates the
output 2400 of the DAC 2206 and what the filtered DAC output might
look like. When power is first applied to the generator, the state
of the NCO 1008 may be undefined (or the output of the NCO 1008 may
not be at a suitable frequency). This could lead to improper
operation of the microcontroller. To ensure proper operation of the
microcontroller, the NCO 1008 is not used to drive the clock
frequency of the microcontroller when power is first applied. A
separate oscillator is used. In one exemplary embodiment, the
separate oscillator is integrated into the microcontroller. Using
this separate oscillator, the microcontroller initializes the
various memory locations internal to the microcontroller and those
in the NCO 1008. Once the NCO 1008 is operating at a suitable
frequency, the microcontroller switches the source of its clock
from the separate oscillator to the NCO 1008.
[0171] If the frequency tuning word is 400, the output frequency is
400*1 MHz/1024=390.625 kHz. In this case, FIG. 25 illustrates the
output 2500 of the DAC 2206 and what the filtered DAC output might
look like. The output sometimes has 2 points per period and
sometimes 3 points. The waveform in FIG. 25 clearly shows the need
for a filter to obtain a clean sine wave.
[0172] Referring back to FIG. 10, the push/pull switching amplifier
1010 converts DC power from the battery controller 703 into a
higher voltage square wave. The output filter/matching network is a
passive filter that changes the square wave from switching
amplifier 1010 into a smooth sinusoidal wave suitable for feeding
to the transducer 902. The motional bridge 1014 is a circuit that
produces a feedback signal in proportion to and in phase with the
mechanical motion of the transducer 902 and waveguide assembly 304.
The feedback amplifier and buffer(s) 1016 amplifies and buffers the
motional feedback signal determined within the motional bridge
1014. As will be explained in greater detail below, the motional
bridge 1014 allows the device to run with a constant
displacement/amplitude mode and varies the voltage as the load
varies. The motional bridge is used to provide amplitude feedback
and, by virtue of using this type of feedback, i.e., motional
feedback, the system is able to run with constant current.
[0173] In one embodiment, the TAG assembly 303 includes one or more
red/green/blue (RGB) LEDs 906, which can be used for a variety of
warning and communication purposes. For example green can indicate
the device is functioning normally whereas red indicates the device
is not functioning normally. It is noted that the placement of the
LEDs 906 at the generator 904 in FIG. 9 is only for illustrative
purposes. The invention envisions placing the indicators anywhere
at the TAG assembly 303.
[0174] Through communicative interaction between the handle
assembly 302 and the TAG assembly 303, in particular, the speaker
802 and the LEDs 906, the inventive handheld ultrasonic surgical
cautery assembly 300 provides full feedback to an operator during
use to indicate a plurality of conditions associated with the
ultrasonic surgical cautery assembly 300. For instance, as
mentioned above, the speaker/buzzer 802 can provide audible
warnings and audible indicators of operational status of the
ultrasonic surgical cautery assembly 300. Similarly, the LEDs 906
can provide visual warnings and visual indicators of operational
status of the ultrasonic surgical cautery assembly 300. As an
example, the LEDs 906 can provide an indication of an amount of
power remaining within the battery cell(s) 701 or a lack of
sufficient power to safely carry out a surgical procedure. For
instance, a first color of the LEDs 906 indicates a fully charged
battery cell(s) 701, while a second color indicates a partially
charged battery cell(s) 701. Alternatively, various blinking
patterns or constant on states of the LEDs 906 can provide
condition indicators to the user. The LED driver 1018 that is shown
in FIG. 10 is an exemplary configuration that provides a constant
current when the LEDs 906 are illuminated. Importantly, all of the
feedback indicators to the user are uniquely present on the
handheld device and do not require the user to be within range of a
remote feedback component that is away from the surgical field of
vision or outside of the sterile field. This eliminates the
requirement for the physician to shift his/her attention from the
surgical field to a remote location to verify the nature of the
feedback signal.
[0175] b. Transducer
[0176] A transducer 902 is an electro-mechanical device that
converts electrical signals to physical movement. In a broader
sense, a transducer 902 is sometimes defined as any device that
converts a signal from one form to another. An analogous transducer
device is an audio speaker, which converts electrical voltage
variations representing music or speech to mechanical cone
vibration. The speaker cone, in turn, vibrates air molecules to
create acoustical energy. In the present invention, a driving wave
1400 (described below) is input to the transducer 902, which then
converts that electrical input to a physical output that imparts
movement to the waveguide 1502 (also described below). As will be
shown with regard to FIG. 15, this movement sets up a standing wave
on the waveguide 1502, resulting in motion at the end of the
waveguide 1502. For purposes of the present invention, transducer
902 is a piezo-electric device that converts electrical energy into
mechanical motion.
[0177] As is known, crystals in piezoelectric transducers expand
when voltage is applied. In a transducer configuration according to
the invention, as illustrated for example in FIG. 55, the crystals
are clamped into a crystal stack 5502. A clamp bolt 5504 in this
configuration acts as a spring if it is set to pre-compress the
crystal stack 5502. As such, when the crystal stack 5502 is caused
to expand by imparting a voltage across the stack 5502, the clamp
bolt 5504 forces the stack 5502 back to its original,
pre-compressed position (i.e., it retracts). Alternatively, the
clamp bolt 5504 can be torqued so that there is no pre-compression
on the stack 5502 and, in such a case, the bolt will still act as a
spring to pull the back mass towards it original position.
Exemplary configurations of the transducer can be a so-called
Langevin transducer, a bolt-clamp Langevin transducer, or a
bolt-clamped sandwich-type transducer.
[0178] IV. Signal Path
[0179] FIG. 12 is a block diagram illustrating the signal path
between the battery assembly 301 and the TAG assembly 303. First, a
DC-DC step-down converter 1202 steps the voltage from the battery
cells 701 down from a first voltage to a second, lower voltage. The
DC-DC step-down converter 1202 includes the multi- or
variable-phase (depending on amount of power needed) buck converter
1114 and the battery microcontroller 1106, which are both shown in
FIG. 11 within the battery assembly 301. The battery
microcontroller 1106 controls the buck converter 1114 to regulate
the DC voltage fed to the TAG assembly 303. Together, the buck
converter 1114 and the microcontroller 1106 perform the DC to DC
conversion function in the battery assembly 301. In an exemplary
embodiment of the invention, a two-phase buck converter 1114 is
used. Another exemplary embodiment can utilize a buck converter
having additional phases. In such a case, phase shedding can be
employed. The number of phases used can change dynamically to keep
the converter operating at optimal efficiency, which is a
consideration for a battery powered device. In other words, when
less output power is required, the power losses internal to the
converter can be reduced by reducing the number of active
phases.
[0180] The DC output voltage from the battery assembly 301 powers
the push/pull switching amplifier 1010 in the TAG assembly 303,
which assembly 303 converts the DC signal to a higher voltage AC
signal. The TAG microcontroller 1006 controls the amplifier 1010.
The output voltage of the push pull switching amplifier 1010 is, in
general, a square wave, an example of which is shown in FIG. 13,
which waveform 1300 is undesirable because it is injurious to
certain components, in particular, to the transducer 902.
Specifically, the abrupt rising and falling edges of a square wave
cause corresponding abrupt starts and stops of the ultrasonic
waveguide to produce a damaging "rattling" affect on the waveguide.
The square wave 1300 also generates interference between
components. For example, higher additional harmonic frequencies of
a square wave can create unwanted electrical interference and
undesired operation of the circuit(s). This is in contrast to a
pure sine wave, which only has one frequency.
[0181] To eliminate the square wave, a wave shaping or matching
circuit 1012 (sometimes referred to as a "tank circuit") is
introduced. The tank circuit 1012 includes such components as, for
example, an inductor, along with a capacitor in conjunction with
the transducer capacitance, and filters the square wave into a
smooth sine wave, which is used to drive the transducer 902 in a
way that produces non-damaging ultrasonic motion at the waveguide.
An exemplary sine wave 1400 suitable for driving the transducer 902
is shown in FIG. 14. The matching circuit 1012, in one exemplary
embodiment of the present invention, is a series L-C circuit and is
controlled by the well-known principles of Kirchhoff's circuit
laws. However, any matching circuit can be used to produce a smooth
sine wave 1400 suitable for driving the transducer 902. In
addition, other driving signals can be output from the matching
circuit 1012 that are not smooth sine waves but are useful for
driving the transducer 902 in a way that is less injurious than a
square wave.
[0182] In practice, the matching network 1012 is tuned to match a
particular transducer to which it feeds. Therefore, transducers and
matching networks are best matched if they remain as a pair and are
not placed in combination with other device. In addition, if each
transducer 902 had its own matching network, the smart battery 301
could feed different frequencies to the different transducers, the
frequencies being respectively matched to a particular blade in a
waveguide assembly 304. Two popular frequencies for ultrasonic
surgery devices are 55 kHz and 40 kHz.
[0183] V. Resonance
[0184] FIG. 15 is a diagrammatic illustration of the affect that a
resonant sine wave input to the transducer 902 has on the waveguide
1502 of the ultrasonic cutting device. In accordance with an
exemplary embodiment of the present invention, the sinusoidal
pattern shown by the dotted lines in FIG. 15 represents the
amplitude of axial motion along the length of the waveguide 1502,
which is coupled to the transducer 902. Responding to a rising
portion 1402 of the driving sine wave 1400 (shown in FIG. 14), the
stack expands in a first direction 1508. During the negative
portion 1404 of the driving wave 1400 (shown in FIG. 14), the
pre-compression or the induced compression of the stack returns the
stack to its steady-state, i.e., the portion 1504 of the transducer
902 is moved in a second direction 1512. As stated above, a smooth
sine wave 1400, in contrast to the square wave 1300, allows the
transducer 902 and waveguide 1502 to slow before changing
directions. The smoother movement is less injurious to the device's
components.
[0185] The alternating movement 1508, 1512 of the transducer
portion 1504 places a sinusoidal wave 1514 along the length of the
waveguide 1502. The wave 1514 alternatively pulls the distal end
1520 of the waveguide 1502 toward the transducer 902 and pushes it
away from the transducer 902, thereby longitudinally moving distal
end 1520 of the waveguide 1502 along distance 1518. The tip of the
waveguide 1502 is considered an "anti-node," as it is a moving
point of the sine wave 1514. The resulting movement of the
waveguide 1502 produces a "sawing" movement along distance 1518 at
the distal end 1520 of the waveguide 1502. (The wave 1514 and
linear movement along distance 1518 are greatly exaggerated in FIG.
15 for ease of discussion.) This high-speed movement along distance
1518, as is known in the art, provides a cutting instrument that is
able to easily slice through many materials, in particular, tissue
and bone. The rapidly moving distal end 1520 of the waveguide 1502
also generates a great deal of frictional heat when so stimulated,
which heat is absorbed by the tissue that the waveguide 1502 is
cutting. This heat is sufficient to cause rapid cauterization of
the blood vessels within the tissue being cut.
[0186] If the driving wave 1514 traveling along the waveguide 1502
is not a resonant wave, there will be no standing wave, which means
that are no nodes or antinodes. This means that there is very
little motion. There also exists the possibility of operating the
device at an incorrect resonant frequency. Operating at the wrong
resonance can produce, for example, undesirable motion such as
"slapping." In such a case, the distal end 1520 of the waveguide
1502 moves transverse to the longitudinal axis of the waveguide
1502. Any incorrect mode is not ideal and is unreliable for
providing adequate cutting and surgical cautery. The invention,
however, as is explained below, utilizes a phase locked loop (PLL)
in the generator 904 to ensure that the movement 1508, 1512 of the
waveguide 1502 remains resonant along the waveguide 1502 by
monitoring the phase between the motional current and motional
voltage waveforms fed to the transducer 902 and sending a
correction signal back to the generator 904. The TAG
microcontroller 1006 controls the frequency and ensures it is in
the proper range so as not to excite an undesired resonant
frequency. As an added feature, the present invention can be
provided with piezo-electric crystal stacks 1504 that are cut in
varying planes, thereby creating a torsional, or twisting motion of
the blade rather than only a sawing motion. The present invention
can easily be adapted to a full set of uses using requiring a
drilling-type motion instead of or with the sawing motion just
described.
[0187] As just explained, ideally, the transducer 902 and waveguide
1502 are driven at their resonant frequency. Resonance is achieved
when current and voltage are substantially in phase at the input of
the transducer 902. For this reason, the generator 904 uses the PLL
and the signals derived from the current and voltage input to the
transducer 902 to synchronize the current and voltage with one
another. However, instead of simply matching the phase of the input
current to the phase of the input voltage, the present invention
matches the current phase with a phase of the "motional" voltage
and/or matches the input voltage phase with a phase of the
"motional" current. To accomplish this, a motional bridge circuit
is used to measure the mechanical motion of the transducer and
waveguide and to provide feedback as to the operation of the
transducer and waveguide. The motional feedback signal from the
bridge is proportional to and in phase with the motion of the
transducer 902 and waveguide 1502.
[0188] VI. Motional Control
[0189] a. Transducer Circuit Model
[0190] FIG. 16 is a schematic circuit diagram of a model transducer
1600, such as transducer 902, which contains piezo-electric
material. Piezo-electric transducers are well known in the art. The
mass and stiffness of the piezo-electric material creates a
mechanically resonant structure within the transducer. Due to the
piezo-electric effect, these mechanical properties manifest
themselves as electrically equivalent properties. In other words,
the electrical resonant frequency seen at the electrical terminals
is equal to the mechanical resonant frequency. As shown in FIG. 16,
the mechanical mass, stiffness, and damping of the transducer 902
may be represented by a series configuration of an inductor/coil L,
a capacitor C.sub.2, and a resistor R, all in parallel with another
capacitor C.sub.1. The electrical equivalent transducer model 1700
is quite similar to the well-known model for a crystal.
[0191] Flowing into an input 1610 of the electrical equivalent
transducer model 1600 is a transducer current i.sub.T. A portion
i.sub.C of i.sub.T flows across the parallel capacitor C.sub.1,
which is of a type and value that, for the majority of the expected
frequency range, retains a substantially static capacitive value.
The remainder of i.sub.T, which is defined as i.sub.M, is simply
i.sub.T-i.sub.C and is the actual working current. This remainder
current i.sub.M is referred to herein as the "motional" current.
That is, the motional current is that current actually performing
the work to move the waveguide 1502.
[0192] Known prior-art designs regulate and synchronize with the
total current i.sub.T, which includes i.sub.C and is not an
indicator of the amount of current actually causing the motion of
the waveguide 1502 of the transducer 902. For instance, when the
blade of a prior-art device moves from soft tissue to denser
material, such as other tissue or bone, the resistance R increases
greatly. This increase in resistance R causes less current i.sub.M
to flow through the series configuration R-L-C.sub.2, and more
current i.sub.C to flow across capacitive element C.sub.1. In such
a case, the waveguide 1502 slows down, degrading its performance.
It may be understood by those skilled in the art that regulating
the overall current is not an effective way to maintain a constant
waveguide displacement. As such, one novel embodiment of the
present invention advantageously monitors and regulates the
motional current i.sub.M flowing through the transducer 902. By
regulating the motional current i.sub.M, the movement distance of
the waveguide 1502 can be regulated easily.
[0193] b. Series Circuit Model
[0194] FIG. 17 is a schematic circuit diagram of an inventive
circuit 1700 useful for understanding how to obtain the motional
current i.sub.M of the transducer 902. The circuit 1700 has all of
the circuit elements of the transducer model 1600 plus an
additional bridging capacitive element C.sub.B in parallel with the
transducer model 1600 of FIG. 16. However, the value of C.sub.B is
selected so that C.sub.1/C.sub.B is equal to a given ratio r. For
efficiency, the chosen value for C.sub.B should be relatively low.
This limits the current that is diverted from i.sub.M. A variable
power source V.sub.T is applied across the terminals 1702 and 1704
of the circuit 1700, creating a current i.sub.B through the
capacitive element C.sub.B, a current i.sub.T flowing into the
model transducer 1600, a current i.sub.C flowing through capacitor
C.sub.1, and, finally, the motional current i.sub.M. It then
follows that i.sub.M=i.sub.T-ri.sub.B. This is because:
i B = C B .differential. V T .differential. t = C 1 r
.differential. V T .differential. t and i C = C 1 .differential. V
T .differential. t ##EQU00001##
Therefore, i.sub.C=ri.sub.B and, substituting for i.sub.C in the
equation i.sub.M=i.sub.T-i.sub.C, leads to:
i.sub.M=i.sub.T-ri.sub.B.
[0195] Now, by knowing only the total current and measuring the
current through the bridge capacitor i.sub.B, variations of the
transducer's motional current i.sub.M can be identified and
regulated. The driver circuit, represented by block 2708 and the
transformer 2710 in FIG. 27, is included in the push-pull switching
amplifier 1010 of FIG. 10. The driver circuit, then, acts as a
current controller and regulates the motional current i.sub.M by
varying an output of the driver circuit based on the product of the
current flowing through the bridge capacitance C.sub.B multiplied
by the ratio r subtracted from a total current i.sub.T flowing into
the transducer 902. This regulation maintains a substantially
constant rate of movement of the cutting blade portion of the
waveguide 1502 across a variety of cutting loads--something that
has not been possible to date. In one exemplary embodiment, sensing
circuits 1014 measure the motional voltage and/or motional current.
Current and voltage measuring devices and circuit configurations
for creating voltage meters and current meters are known in the
art. Values of current and voltage can be determined by the present
invention in any way now known or later developed, without
limitation.
[0196] Regulation of the motional current i.sub.M is a true way to
maintain the integrity of the instrument and ensure that it will
operate at its peak performance under substantially all conditions
expected in an operating environment. In addition, such regulation
provides these advantages within a package small enough and light
enough to be easily held in one hand--a configuration that has
never occurred in the field.
[0197] c. Transducer Circuit Model
[0198] FIG. 18 shows another embodiment of the present invention,
where the transducer 902 is schematically represented as a parallel
configuration of a resistive element R, an inductive element L, and
a capacitive element C.sub.4. An additional capacitive element
C.sub.3 is in a series configuration between an input 1702 and the
parallel configuration of the resistive element R, the inductive
element L, and the capacitive element C.sub.4. This parallel
representation models the action of the transducer in a so-called
"antiresonant" mode of operation, which occurs at a slightly
different frequency. A transducer voltage V.sub.T is applied
between the input terminals 1702, 1704 of the transducer 902. The
transducer voltage V.sub.T is split between a voltage V.sub.C
across capacitive element C.sub.3 and a motional voltage V.sub.M
across the parallel configuration of the resistive element R, the
inductive element L, and the capacitive element C.sub.4. It is the
motional voltage V.sub.M that performs the work and causes the
waveguide 1502 to move. Therefore, in this exemplary embodiment, it
is the motional voltage that is to be carefully regulated.
[0199] d. Parallel Circuit Model
[0200] FIG. 19 shows an exemplary embodiment of an inventive
circuit configuration 1900, according to the present invention
including the transducer model 1800 of FIG. 18. The circuit
configuration 1900 adds to the transducer model 1800 three
additional capacitive elements C.sub.5, C.sub.6, and C.sub.7.
Capacitive element C.sub.5 is in series with the transducer model
circuit 1800 of FIG. 18 while the capacitive elements C.sub.6 and
C.sub.7 are in series with one another and, together, are in
parallel with the series combination of the capacitive element
C.sub.5 and the transducer circuit model 1800.
[0201] This circuit is analogous to a Wheatstone bridge measuring
instrument. Wheatstone bridge circuits are used to measure an
unknown electrical resistance by balancing two legs of a bridge
circuit, one leg of which includes the unknown component. In the
exemplary circuit configuration shown in FIG. 10, a motional
voltage V.sub.M, which equals V.sub.T-V.sub.C, is the unknown. By
determining and regulating the motional voltage V.sub.M, the
inventive configuration allows a consistent waveguide movement to
be maintained as set forth below.
[0202] Advantageously, the capacitive element C.sub.7 is selected
so that its value is a ratio A of capacitive element C.sub.3, with
A being less than one. Likewise, the capacitive element C.sub.6 is
selected so that its value is the same ratio A of the capacitive
element C.sub.5. The ratio of C.sub.5/C.sub.3 is also the ratio
A.
[0203] Because the ratio of C.sub.3/C.sub.7 is A and the ratio of
C.sub.5/C.sub.6 is also A, the bridge is balanced. It then follows
that the feedback voltage V.sub.fb divided by the motional voltage
V.sub.M is also the ratio A. Therefore, V.sub.m can be represented
as simply AV.sub.fb.
[0204] If the voltage across the model transducer 1800 is still
V.sub.T, an input voltage V.sub.in equals V.sub.T plus the voltage
V.sub.B across the capacitive element C.sub.5. The feedback voltage
V.sub.FB is measured from a first point located between capacitive
elements C.sub.6 and C.sub.7 and a second point located between the
transducer and the capacitive element C.sub.5. Now, the upstream
components of the TAG assembly 303 act as a voltage controller and
vary the power V.sub.in to maintain a constant feedback voltage
V.sub.fb, resulting in a substantially constant motional voltage
and maintaining a substantially constant rate of movement of the
cutting blade portion of the waveguide 1502 across a variety of
cutting loads. Again, unlike the prior art, the present invention
is not simply regulating the input voltage V.sub.in, it is varying
the input voltage V.sub.in for the purpose of regulating the
motional voltage V.sub.M--which is novel in the art.
[0205] e. Transformer Series Monitoring
[0206] FIG. 20 shows another exemplary embodiment of the present
invention where the transducer 902 is of the circuit configuration
shown in FIG. 16. The configuration of FIG. 20 works similarly to
that shown in FIG. 17 and as described above in connection with
FIG. 17. However, in this circuit configuration 2000, a pair of
transformers 2004 and 2008 is used to determine and monitor the
motional current I.sub.M. In this exemplary embodiment, a primary
winding 2002 of the first transformer 2004 is in a series
configuration with a bridge capacitor C.sub.B. Similarly, a primary
winding 2006 of the second transformer 2008 is in a series
configuration with the model transducer 1600. The leads 2010, 2012
of the secondary winding 2014 of the first transformer 2004 are
coupled through a resistor R.sub.2. The leads 2016, 2018 of the
secondary winding 2020 of the second transformer 2008 are coupled
through a resistor R.sub.1. In addition, the first lead 2010 of the
secondary winding 2014 of the first transformer 2004 is directly
connected to the first lead 2016 of the secondary winding 2020 of
the second transformer 2008.
[0207] Current i.sub.B passing through the primary winding 2002 of
the first transformer 2004 induces a current in the secondary
winding 2014 of the first transformer 2004. Similarly, the currents
including i.sub.C passing through the capacitive element C.sub.1 of
the transducer 1600 and the motional current i.sub.M of the
transducer 1600 combine and go through the primary winding 2006 of
the second transformer 2008 to find ground 2022. The current in the
primary winding 2006 induces a current on the secondary winding
2020. As noted by the dots (" ") on the transformers 2004, 2008,
the secondary windings 2014, 2020 are in opposite directions from
one another, with reference to the primary windings 2002, 2006,
respectively, and induce a voltage V.sub.fb across resistors
R.sub.1 and R.sub.2. By selecting values for R.sub.1 and R.sub.2 so
that a ratio of R.sub.1/R.sub.2 is equal to the ratio of the values
C.sub.B/C.sub.1, the feedback voltage V.sub.fb will always be
proportional to the motional current i.sub.M. Now, the upstream
components of the generator 904 act as a voltage controller and
vary the input power (V.sub.in and I.sub.in) to maintain a constant
feedback voltage V.sub.fb, resulting in a substantially constant
motional current i.sub.M and maintaining a substantially constant
rate of movement of the cutting blade portion of the waveguide 1502
across a variety of cutting loads. Again, unlike the prior art, the
present invention is not simply regulating the input voltage
V.sub.in, it is varying the input current for the purpose of
regulating the motional current i.sub.M--which is novel in the
art.
[0208] f. Transformer Parallel Monitoring
[0209] FIG. 21 shows another exemplary embodiment of the present
invention where the model transducer 1800 is modeled by the circuit
configuration shown in FIG. 18. The configuration of FIG. 21 works
similarly to that shown in FIG. 19 and as described above in
connection with FIG. 19. However, in this circuit configuration
2100, a transformer 2110 is used to determine and monitor the
motional voltage V.sub.M of the transducer 1800. In this
embodiment, a primary winding 2106 of the transformer 2110 is in a
series circuit configuration with an inductive element L.sub.2 and
a capacitive element C.sub.1. A voltage V.sub.in is applied across
input leads 2102, 2104 of the circuit formed by the primary winding
2106 of the transformer 2110, the inductive element L.sub.2, and
the capacitive element C.sub.1. A current through the primary
winding 2106 induces a corresponding current in the secondary
winding 2108 of the transformer 2110. The secondary winding 2108 of
the transformer 2110 is in a parallel configuration with a
combination of the transducer 1800 and a bridge capacitor C.sub.B.
The two components forming the combination are in a series
configuration.
[0210] In this embodiment, the secondary winding 2108 is tapped at
a point 2112. By tapping the secondary winding 2108 at a point
where a first portion of the secondary winding 2108 has m turns and
a second portion of the secondary winding 2108 has n turns (where n
is less than m), a selectable percentage of the induced voltage on
the secondary winding 2108 appears from point 2112 to ground
2114.
[0211] Again, this circuit is analogous to a Wheatstone bridge
measuring instrument. One leg is the first secondary winding m, the
second leg is the second secondary winding n, the third leg is the
transducer model 1800, and the fourth leg is the capacitor C.sub.B.
In the instant circuit configuration shown in FIG. 21, the voltage
V.sub.M is the unknown. By determining and regulating the motional
voltage V.sub.M, a consistent waveguide movement is maintained.
[0212] By selecting a value of the bridge capacitor C.sub.B to be
less than the transducer capacitance C.sub.3 by the same percentage
that the number of turns n is less than the number of turns m
(i.e., m/n=C.sub.3/C.sub.B), the value of a feedback voltage
V.sub.fb will reflect the motional voltage V.sub.M. The invention
can determine whether the motional voltage V.sub.M is changing by
monitoring the feedback voltage V.sub.fb for changes.
[0213] By using the equivalent-circuit transducer model 1800, which
models a parallel-resonant (or "anti-resonant") transducer, the
transducer may be driven in the parallel resonant mode of
operation, where motion is proportional to voltage. The advantage
of this mode of operation is that the required
constant-voltage-mode power supply is simpler to design and safer
to operate than a constant-current-mode power supply. Also, because
the transducer has a higher impedance when unloaded (rather than a
lower impedance when unloaded in the series-resonant mode of
operation), it naturally tends to draw less power when unloaded.
The parallel-resonant mode of operation, however, is more difficult
to maintain because the resonant bandwidth is narrower than that of
the series-resonant mode and has a slightly different natural
resonant frequency; hence, the mechanical components of the device
must be specifically configured to operate at either the series
resonant or parallel-resonant mode of operation.
[0214] The present invention controls the voltage and varies the
power V.sub.in to maintain a constant feedback voltage V.sub.fb,
resulting in a substantially constant motional voltage V.sub.M and
maintains a substantially constant rate of movement of the cutting
blade portion of the waveguide 1502 across a variety of cutting
loads. Again, unlike the prior art, the present invention is not
simply regulating the input voltage V.sub.in, it is varying the
input voltage V.sub.in for the purpose of regulating the motional
voltage V.sub.M--which is novel in the art.
[0215] In accordance with the present invention, the
microcontroller 1006 in the TAG 303 monitors the feedback signal
through motional bridge 1014 to generate the signal that goes to
the primary side of transformer 1010. The TAG microcontroller 1006
calculates (in the CLA 912) the phase difference between these
signals and adjusts the NCO 1008 output to make the phase
difference equal to zero. When the motional feedback signal is in
phase with the output of the push-pull switching amplifier 1010,
the system is operating at series resonance. The phase and
magnitude of the motional feedback signal is computed using a
discrete Fourier transform (DFT). In one exemplary embodiment of
the present invention, the phase reference for the DFT computation
is the drive signal for the push-pull amplifier 1010. The frequency
can be changed to cause the push-pull drive signal to be in phase
with the motional feedback signal.
[0216] According to one exemplary embodiment of the present
invention, if the phase of the motional feedback signal is
positive, it is an indication the running frequency is below the
resonant frequency and the running frequency should be increased;
if the phase is negative, it is an indication the running frequency
is above the resonant frequency and the running frequency should be
decreased; if the phase is close to zero, the running frequency is
close to the resonant frequency of the transducer 902 and waveguide
1502. In the generator 904, the NCO 1008 (utilizing DDS) is used to
alter the frequency appropriately.
[0217] Significantly, the NCO 1008 outputs a clock to the CPU's
external clock input at a frequency, for example, 6 times less that
the operating frequency of the TAG microcontroller 1006. The
external frequency input is fed into the processor's Phase Lock
Loop (PLL) and multiplied by a factor of 6 to obtain the CPU's
SYSCLK. The NCO 1008 is controlled by the processor through an SPI
interface. The SPI interface is used to write a 32-bit divisor to
the NCO 1008 that is used to divide the 25-MHz fixed frequency
clock to obtain the desired output frequency. By controlling the
DDS 2200, the TAG provides synchronized operation of hardware with
the oscillation frequency. In other words, to the main processor
914, it appears as though the frequency is constant, thereby
simplifying the sampling and calculation of the motion feedback
phase.
[0218] VII. Startup Operation
[0219] Startup conditions are different than those during steady
state operation, which is described in detail in the following
section. At startup, the waveguide 1502 is initially at rest and,
therefore, there is no waveguide motion. Accordingly, there is no
immediate, ascertainable motional feedback signal that can be used
to determine the composite resonant frequency of the transducer 902
and waveguide 1502. As a result, the inventive system has an
ability to operate in a different mode during an initial startup
period than during steady state.
[0220] A startup procedure according to an exemplary embodiment of
the present invention is represented in the process flow diagram of
FIG. 72, which illustrates an interchange between the battery
controller 703 and the generator 904 of the TAG assembly 303. In
this particular embodiment, as described in detail below, the
relationship between the battery controller and generator can be
described as a "master-and-slave" relationship, as the battery
controller issues all commands to the generator 904 and the
generator 904 receives all of its instructions from the battery
controller 703. Alternatively, the generator 904 of the TAG
assembly 303 could act as the "master" and issue all commands to
the battery controller 703, or, the generator 904 of the TAG
assembly 303 and the battery controller 703 may function as
peers.
[0221] Prior to activation, both the battery controller 703 and the
generator 904 are idle at steps 7201 and 7202, respectively. In
step 7203, the battery controller 703 is awakened out of its idle
condition, for example, by the user squeezing the button/trigger
4608. To begin the exchange between the battery controller 703 and
the generator 904, the battery controller 703 relays a signal, such
as an "ULTRASOUND ON" command 7205, to the generator 904 using the
communication lines 602a-n (i.e., Comm+/Comm-). If operating
properly, the generator acknowledges the command 7205 received from
the battery controller 703 and, in return, signals a positive
response 7204, such as an "ULTRASOUND ON" response, to the battery
controller 703 using the communication lines 602a-n (i.e.,
Comm+/Comm-). However, if the generator 904 does not positively
respond to the initial command 7205 from the battery controller 703
before a specific period of time has lapsed (e.g., 10 ms), the
battery controller issues a fault condition at step 7207, such as a
"FAILURE TO START" condition, and terminates the operation cycle at
step 7209. At such time, appropriate indicators can be
actuated.
[0222] a. Current and Amplitude Control
[0223] If there is a successful acknowledgment by the generator 904
of the "ULTRASOUND ON" command 7205 sent from the battery
controller 703, the microcontroller 1106 in the battery controller
703 initiates a process for quickly and safely advancing the
current rate in the TAG assembly 303 and resulting in a resonant
motion output from the TAG assembly 303 to the waveguide 1502.
Advancement proceeds from an idle condition to a level predicted to
be within a "ballpark window" for producing an ascertainable
motional feedback signal and achieving a beginning resonant
frequency condition. As shown in FIG. 11, the microcontroller 1106
in the battery controller 703 has two processing units. A first
processing unit, the Control Law Accelerator ("CLA") 1116, handles
a first, inner, current-control loop 2601 (see FIG. 26), and the
second processing unit, a main processor 1118, handles a second,
outer, amplitude-control loop 2602 (see FIG. 26). At the outset, in
step 7213, microcontroller 1106 turns on the buck power supply 1114
and initializes the CLA 1116. The CLA 1116 uses a
proportional-integral-derivative ("PID") control algorithm to
compute a new duty cycle value for the Pulse Width Modulators
("PWMs") that are driving the two-phase buck converter 1114. At
step 7215, the battery controller 703 starts the PWMs and begins,
at step 7211, using a fast, non-linear PID control loop, to
increase the output voltage of the DC-DC converter 1202. The
increasing output voltage causes a corresponding increase in the
input current to the push/pull amplifier 1010 of the generator 904.
At step 7217, the output voltage increases, or is otherwise
modified, until, at step 7219, the actual, measured input current
reaches a predetermined reference current level, referred to herein
as "I.sub.ref." I.sub.ref is a calibrated value that is predicted
to create a driving wave output from the transducer 902 that will
achieve a displacement of the waveguide 1502 and place the
resulting amplitude near a value sufficient to reach the target
resonant frequency. I.sub.ref is initially set by the battery
microcontroller 703 in step 7225. This calibrated value for
I.sub.ref may be stored inside the TAG assembly 303 and read by the
battery microcontroller 703 upon establishment of the communication
link 7204.
[0224] Table 1 below illustrates an example of a non-linear PID
control loop or algorithm in accordance with the present invention,
whereby the output voltage level is modified until the actual,
measured input current reaches the reference current, I.sub.ref. In
this example, the non-linear PID control loop divides the percent
error of the actual, measured input current versus the reference
current I.sub.ref into 5% bins, which are shown below as constants
G.sub.0 through G.sub.n (whereby "n" is some number of the last
step prior to reaching I.sub.ref). Each bin has its own non-linear
tuning coefficients (e.g., K.sub.p, K.sub.i, and K.sub.d). The
non-linear tuning coefficients allow for the output voltage and, in
turn, the actual input current, to initially advance quickly
towards the reference current point I.sub.ref when the input
current is far away from the reference current point, and then
slowly reach the reference current point I.sub.ref once the input
current value is close to reaching the reference current point. As
a result, the system is less prone to being disturbed by noise. In
this particular example, the non-linear PID within the CLA 1116
shapes the overshoot to no more than 15% greater than I.sub.ref. It
is desirable to have the control loop maintain current but not to
allow over current for any significant time; in other words, the
loop must make the current retract from an overcurrent state
quickly. Accordingly, the non-linear PID loop of the CLA 1116
shapes the increase of the output voltage and input current in such
a way that the input current advances quickly and accurately to the
desired reference current level I.sub.ref, but does so in such a
way that is stable and avoids a dangerous "overcurrent"
condition.
TABLE-US-00001 TABLE 1 ##STR00001##
[0225] In the meantime, while the input current is steadily
increasing under the control of the battery microcontroller 1106,
the initial signal, i.e., the "ULTRASOUND ON" command 7205 from the
battery controller 703, received by the generator, causes the TAG
microcontroller 1006 to begin its own initialization process in
parallel with the operation of the battery controller 703. As set
forth above with regard to FIG. 9, the microcontroller 1006 in the
TAG assembly 303 has two independent processing units: the CLA 912
and the main processor 914. Referring back to FIG. 72, at steps
7200 and 7206, upon receiving the initial command 7205 from the
battery controller 703, the TAG microcontroller 1006 initializes
the CLA 912 and starts the ultrasound PWMs that drive the
ultrasonic frequency at a frequency within the operating frequency
range of the waveguide and transducer. At this initial start up
stage, any motional feedback signal that is present is weak and,
therefore, it is desirable to use a high gain amplifier to provide
a higher signal level because the signal level is initially very
small. At step 7208, as the input current from the battery assembly
is increasing, the amplitude (i.e., the displacement of the
mechanical motion) is incrementing proportionally until it reaches
a set point or level within 20% of a "target amplitude," which
should produce a motional feedback signal and place the TAG
assembly 303 in a "ballpark window" for achieving the resonant
frequency. The "target amplitude" is a pre-determined, safe,
threshold level. It is undesirable to surpass this threshold level
and, when surpassed (e.g., by 10-12%), indicates an
"over-amplitude" condition that is undesirable and causes the
device to initiate a fault condition and control shutdown.
[0226] To regulate the amplitude level of the TAG assembly 303, the
battery controller 703 closely monitors the amplitude level. The
battery controller 703 issues a command 7221 at frequent intervals
(e.g., every 4 ms), such as an "AMPLITUDE REQ" command, to the TAG
assembly 303 using at least one of the communication lines 602a-n
(e.g., Comm+/Comm-). In response, the battery controller 703
receives a signal 7210, through at least one of the communication
lines 602a-n (e.g., Comm+/Comm-), such as an "AMPLITUDE REQ"
response, from the TAG assembly 303, which provides the battery
controller 703 with a measurement of the amplitude level of the TAG
assembly 303. At each interval that a measurement of the amplitude
level is determined by the battery controller 703, the battery
microcontroller 1106, at step 7223, makes one of several possible
determinations based upon the amplitude measurement. If the
amplitude level has reached the level of within 20% of the "target
amplitude," or, effectively, 80% of the "target amplitude," in step
7227, the power control is switched from the inner, current-control
loop 2601 to the outer, amplitude-control loop 2602, which is
described in further detail below. If the amplitude level has not
yet reached 80% of the "target amplitude," in step 7229, the
current control loop will maintain the current at the reference
current level I.sub.ref until the amplitude reaches the 80%
point.
[0227] However, if the amplitude level still has not reached the
80% point within a set period of time (e.g., 250 ms), this
indicates a "low amplitude" fault condition 7231 that may be due
to, for example, a stalled blade of the waveguide 1502. In
response, the battery microcontroller 1106 terminates the operation
cycle at step 7209 and issues, for example, an "ULTRASOUND OFF"
command 7233, to the generator 904. In return, the generator 904
relays a response 7212, such as an "ULTRASOUND OFF" response,
indicating that it has ceased active operation. If the potentially
dangerous condition occurs in which the amplitude level has
actually surpassed the level of within 20% of the "target
amplitude," the battery microcontroller 1106 immediately issues a
fault condition 7235 and terminates the operation cycle at step
7209, as described above, due to this "over-amplitude"
condition.
[0228] b. Frequency Lock
[0229] Now, referring to FIG. 72A, as previously mentioned, upon
initialization, the TAG microcontroller 1006 controls the frequency
of the signal that drives the transducer 902 based upon its
detection of the motional feedback signal. At the beginning of the
startup process, in step 7206, the operating frequency is set at a
fixed value that is within the operating frequency range of the
transducer 902 and waveguide 1502 (e.g., 55.2 kHz). If present at
that set frequency, a motional feedback signal from the bridge
circuit is routed to a high and low gain buffer. Each of these
signals is fed into the analog-to-digital converter ("ADC") 908 of
the microcontroller 1006 in the TAG assembly 303. Initially, the
high-gain, buffered-feedback signal is selected as the motional
feedback signal will initially be small. A main function of the CLA
912 is to take the output from the ADC, perform the Discrete
Fourier Transform ("DFT") calculations, and pass the results to the
main processor 914. Shown as step 7218, the results from the DFT
calculations are the phase and magnitude of the motional feedback
("MF") signal, as well as the real and imaginary terms for the
signal.
[0230] A tuning loop is called once per ultrasound cycle. If, at
step 7214, it is determined that a valid motional feedback signal
does not exist at the set frequency, the system simply waits until
there is a valid motional feedback signal. However, if a fixed
period of time has been exceeded as determined by a cycle timeout
timer, and there is still no valid motional feedback signal, a
cycle activation limit "timeout" is triggered at step 7216 and the
generator 904 turns off.
[0231] Initially, at step 7222, the system employs a
high-gain-buffered A-to-D channel such that the high-gain-buffered
feedback signal is selected. This allows the system to lock at a
lower motional feedback signal level. A determination of whether or
not the motional feedback signal has reached a defined "THRESHOLD"
value is made at step 7220. If the motional feedback signal has
reached the defined "THRESHOLD" value, the amplitude of the
motional feedback signal has increased to the point that a valid
motional feedback signal has emerged from any obstructive noise
such that the DFT calculations in the CLA 912 are reliable. At this
point, in step 7224, the system switches to the low-gain channel.
However, should the system fall below this "THRESHOLD" value, the
A-to-D channel can switch back to the high-gain channel as shown in
step 7226. By having the ability to switch to the low-gain channel
at this point, a higher resolution A/D converter is beneficially
not required.
[0232] At step 7228, if the motional feedback signal is above a
starting threshold value, the generator 904 enters a
frequency-tuning mode for locking the set frequency onto the
resonant frequency of the TAG assembly 303 in parallel with the
current and amplitude controls described above. In accordance with
an exemplary embodiment of the present invention, the process for
achieving resonant frequency is not a process of sweeping for the
optimum frequency, but rather is uniquely a tracking or tuning
process for locking onto the optimum frequency. However, the
present invention may also employ a frequency sweeping mode whereby
the initial operating or set frequency is chosen to be at a lower
boundary of the "ballpark window" of the predicted resonant
frequency and is steadily incremented until it reaches the resonant
frequency or vice versa.
[0233] Once frequency tuning mode is entered, the main processor
914 of the TAG microcontroller 1006 uses the results of the DFT
calculation (i.e., the phase and magnitude of the motional feedback
signal) to control the running frequency of the generator. The
tuning algorithm is divided into two states: STARTING and LOCKING.
In the STARTING phase at step 7230, a determination is made of
whether or not the motional feedback signal has reached a defined
"STARTUP THRESHOLD" value. If the motional feedback signal has
reached the defined "STARTUP THRESHOLD" value, the amplitude of the
motional feedback signal has increased to the point that the system
can actively begin moving towards resonance at step 7232. If the
determination at step 7230 is that the motional feedback signal has
not reached the defined "STARTUP THRESHOLD" value, the process
moves to step 7234. At step 7234, the STARTING phase simply waits
until the point is reached whereby there is a large enough motional
feedback signal to allow locking.
[0234] In the LOCKING phase 7236, the sine of the phase offset
between the motional feedback signal and the driving signal is used
along with the differential of the sine to determine the size and
direction of the frequency step to adjust the output frequency to
move the system to resonance. Although the phase is naturally a
tangent function, the sine of the phase is used to determine the
frequency step because it is bounded by the value .+-.1 and closely
approximates the phase value at small angles, whereas a tangent
function has the undesirable, unbounded range of .+-..infin..
[0235] In step 7238, a PID loop is used to calculate the frequency
step in either a plus or minus direction. The PID loop is
non-linear, whereby the value of the sine is used to determine a
bin number. That bin number is used as an index to access the
tuning coefficients used by the PID. An index table contains the
proportional gain, the integral gain, and the differential gain. In
addition, the entry sine value to enter a bin differs from the
value to exit a bin. This introduces hysteresis to prevent
oscillations near the bin transitions.
[0236] As previously explained, a non-linear PID is used to achieve
a rapid frequency lock. Table 2 below illustrates an example of a
non-linear, asymmetric PID loop or algorithm in accordance with the
present invention whereby the size in frequency step is staggered
until it reaches the target resonance frequency, f.sub.res. In this
example, the gain constants PID.sub.0 through PID.sub.n (whereby
"n" is some number of the last frequency step prior to reaching
f.sub.res) are separated by non-linear increments. The gain values
have been chosen to move the system toward resonance quickly when
the system is far from resonance and slowly when the system is
close to or at resonance. It is important to step slowly when close
to or at resonance in order to avoid inducing frequency modulation,
which would cause undesirable effects on the amplitude. During
startup, the value for the maximum frequency step size is greater
than during steady state operation; it is, for example, set to 8
Hz. If the phase is positive, it is an indication that the running
frequency is below the resonant frequency of the transducer and
needs to be increased. If the phase is negative, it is an
indication the running frequency is above the resonant frequency
and the running frequency should be decreased. If the phase is
close to zero, the running frequency is close to the resonant
frequency of the transducer 902 and waveguide 1502. The numerically
controlled oscillator ("NCO") 1008 utilizing direct digital
synthesis ("DDS") is used to change the frequency at step 7240.
TABLE-US-00002 TABLE 2 ##STR00002##
[0237] The DDS 2200 (see FIG. 22) provides synchronized operation
of hardware with the oscillation frequency. In other words, to the
main processor 914, it appears as though the frequency is constant.
Here, the clock frequency of the main processor 914 is a multiple
of the oscillation frequency. The invention alters the PWM
frequency in a unique and novel way. With the invention, PWM is
performed inside the main processor 914. Because of this, the
present invention actually increases/decreases the frequency of the
main processor 914--which has not been done before. The A/D
converter 908 adjustments are automatic as well because the A/D
converter 908 exists inside the microcontroller 1006. This
inventive technique can be analogized to a singer adjusting a speed
of a metronome to match the singer's tempo rather than, as is
conventionally done, the singer changing her/his tempo to match the
metronome.
[0238] At anytime during operation of the device, if the frequency
reaches a pre-set minimum or maximum frequency limit, f.sub.min and
f.sub.max, respectively, the generator 904 turns off and a fault
condition is triggered, as shown in step 7242. Exemplary lower and
upper frequency limits for the invention are 54 kHz and 58 kHz,
respectively. A number of various conditions can cause the
frequency to reach the minimum or maximum limit, including breakage
of a component (such as the waveguide 1502) or a situation in which
the waveguide 1502 is under such a heavy load that the device is
not able to input the amount of power needed to find resonance.
[0239] Once frequency lock is achieved, the transition begins into
steady state operation.
[0240] VIII. Steady State Operation
[0241] During steady state operation, the objective is to maintain
the transducer and waveguide at resonant frequency and to control
the amplitude in response to any drifting that occurs as a result
of a load on the waveguide 1502 during use of the device. When the
transducer 902 and waveguide 1502 are driven at their composite
resonant frequency, they produce a large amount of mechanical
motion. The electrical energy from the battery is, in this state,
converted into a high voltage AC waveform that drives the
transducer 902. The frequency of this waveform should be the same
as the resonant frequency of the waveguide 1502 and transducer 902,
and the magnitude of the waveform should be the value that produces
the proper amount of mechanical motion.
[0242] a. Amplitude Control
[0243] At resonance, the amplitude is approximately proportional to
the transducer current, and the transducer current is approximately
proportional to the input current to the push/pull amplifier 1010.
With constant current operation to maintain constant amplitude, the
output voltage will vary with a varying load. In other words, the
voltage will increase if the output power requirement increases and
vice versa.
[0244] As described above in relation to the startup process, shown
in FIG. 26 are two control loops, an inner, current control loop
2601 and an outer, amplitude control loop 2602 for uniquely
regulating the amplitude of the driving wave input to the
transducer 902. The current control loop 2601 regulates the current
from the battery assembly 301 going into the push/pull amplifier
1010. The amplitude control loop 2602 compensates for load
differences or any other changes that occur in the transducer
and/or waveguide. To accomplish this goal, the amplitude control
loop 2602 utilizes the motional feedback signal to generate the
desired reference current level, "I.sub.ref," that is used by the
current control loop 2601 to alter the output voltage of the DC-DC
converter as described above. To avoid interference-type
interactions between the two loops, the current control loop 2601
operates at a higher frequency than the amplitude control loop
2602, e.g., approximately 300 KHz. The amplitude control loop 2602
typically operates, for example, at a frequency of 250 Hz.
[0245] To determine the desired reference current level, I.sub.ref,
the present amplitude value is subtracted from the desired "target
amplitude" to generate an amplitude percent error signal. This
amplitude percent error signal is the input into the PID control
algorithm of the amplitude control loop 2601 for generating the
new, desired reference current level "I.sub.ref," based upon the
operating conditions being experienced by the transducer 902 and
waveguide 1502 at that particular time. In other words, the
amplitude control loop 2602 changes the target or reference current
value for the CLA 912 of the current control loop 2601 to reach the
desired amplitude based on the percent error calculation. In this
way, the output power is altered based on the variable need of the
transducer 902 and waveguide 1502. The main processor 1118 of the
battery controller 703 checks the new reference current value to
make sure that it is not greater than the maximum output current
value.
[0246] Based upon the new target or reference current value,
I.sub.ref, that is set by the amplitude control loop 2602, the
current control loop 2601 proceeds to change the output voltage and
input current to the push/pull amplifier 1010. A measurement of the
actual current level 2603 of the battery pack output is fed into
the ADC 1120 of the battery microcontroller 1106 (shown in FIG.
11). The CLA 1116 takes the value from the ADC 1120 and subtracts
it from the target or reference input current level I.sub.ref to
generate the current error signal. As described above, the CLA 1116
uses the PID control algorithm to compute a new duty cycle value
for the PWMs that are driving the two-phase buck converter 1114.
The CLA 1116 also computes a maximum PWM duty cycle to limit the
output voltage. The algorithm to compute the maximum duty cycle
uses the measured battery voltage and assumes the buck converter
1114 is operating in continuous conduction mode.
[0247] It is noted that, by utilizing amplitude control, rather
than only looking at the current for steadying the amplitude, the
present invention uniquely allows for finely adjusting the output
of the transducer based on the motion feedback signal, achieving a
more precise amplitude control. The use of a current control loop
allows for faster initial response that would not be possible with
amplitude control alone. Also, having the two loops provides for
redundancy and individual calibration of the transducer and
generator during manufacture, which can be referred to as a
"calibration factor." In effect, two control loops are being used
to regulate the amplitude of the driving wave input to the
transducer, which provides synchronized operation of the hardware
with the oscillation frequency. Redundancy is useful to ensure the
device is operating correctly. A malfunction in one loop will
usually be detectable because the other loop will be unable to
operate properly and the improper operation of either loop is
usually detectable. Improper operation can be caused by a hardware
fault. The proper operation of both loops requires measurement of
both current and amplitude. Different hardware is used to measure
amplitude and current. In one embodiment the battery
microcontroller 1106 measure current and the TAG microcontroller
1006 measures amplitude.
[0248] b. Frequency Control
[0249] In a similar operation to the initial frequency lock
performed during the startup process, the main processor 914 of the
generator 904 uses the results of the DFT calculation to adjust the
running frequency of the generator 904 based on the phase of the
motional feedback signal in order to maintain a resonant frequency
during steady state operation. The motional feedback signal from
the bridge circuit is proportional to and in phase with the motion
of the transducer 902 and waveguide 1502. When the motional
feedback signal is in phase with the output of the push/pull
switching amplifier 1010, the system is operating at the series
resonance. Again, the phase and magnitude of the motional feedback
signal is computed using a Discrete Fourier Transform ("DFT"). The
phase reference for the DFT computation is the drive signal for the
push/pull amplifier 1010. The frequency is, then, simply changed to
cause the push/pull drive signal to be in phase with the motional
feedback signal.
[0250] The DFT calculation is simplified and made more accurate if
the ADC sample time interval is exactly an integer multiple of the
output frequency period. This technique is referred to herein as
"coherent sampling." In one exemplary embodiment, the signals are
sampled 12 times per output cycle such that the CLA 912 is sampling
the motional feedback signal at 12 times the ultrasonic frequency.
With coherent sampling, there are exactly 12 samples per cycle with
each occurring at the same point in time relative to the phase of
the drive signal. As shown in FIG. 9, the ADC sample clock is
generated internally in the TAG microcontroller's 1006 system clock
916. Accordingly, for coherent sampling, the system clock 916 needs
to be synchronized to the output. The PWM signal driving the
metal-oxide field-effect transistors (MOSFETs) that, in turn,
generate the output waveform, is also generated internally from the
system clock 916. One exemplary embodiment of the present invention
generates the system clock 916 from the DDS 1008. Advantageously,
as the output frequency changes, the system clock 916 also
changes.
[0251] It is also desirable not to sample shortly after the MOSFETs
are switched on or off. This is when there is the largest amount of
noise present in the system. Offsetting the sample time to avoid
sampling shortly after the MOSFETs switch on or off minimizes the
affect of transistor switching noise on the ADC sample. The two PWM
outputs employ a deadband to ensure that both MOSFETs are never
activated at the same time.
[0252] X. Simplified Circuit Block Diagram
[0253] FIG. 27 shows a simplified block circuit diagram
illustrating another exemplary electrical embodiment of the present
invention, which includes a microprocessor 2702, a clock 2730, a
memory 2726, a power supply 2704 (e.g., a battery), a switch 2706
(e.g., a MOSFET power switch), a drive circuit 2708 (PLL), a
transformer 2710, a signal smoothing circuit 2712 (also referred to
as a matching circuit and can be, e.g., a tank circuit), a sensing
circuit 2714, a transducer 902, and a waveguide assembly 304, which
terminates at an ultrasonic cutting blade 1520, referred to herein
simply as the waveguide 1502.
[0254] One feature of the present invention that severs dependency
on high voltage (120 VAC) input power (a characteristic of all
prior-art ultrasonic cutting devices) is the utilization of
low-voltage switching throughout the wave-forming process and the
amplification of the driving signal only directly before the
transformer stage. For this reason, in one exemplary embodiment of
the present invention, power is derived from only a battery, or a
group of batteries, small enough to fit either within the handle
assembly 302. State-of-the-art battery technology provides powerful
batteries of a few centimeters in height and width and a few
millimeters in depth. By combining the features of the present
invention to provide an entirely self-contained and self-powered
ultrasonic device, the capital outlay of the countertop box 202 is
entirely eliminated--resulting in a significant reduction of
manufacturing cost.
[0255] The output of the battery 2704 is fed to and powers the
processor 2702. The processor 2702 receives and outputs signals
and, as will be described below, functions according to custom
logic or in accordance with computer programs that are executed by
the processor 2702. The device 2700 can also include a main memory
2726, preferably, random access memory (RAM), that stores
computer-readable instructions and data.
[0256] The output of the battery 2704 also is directed to a switch
2706 having a duty cycle controlled by the processor 2702. By
controlling the on-time for the switch 2706, the processor 2702 is
able to dictate the total amount of power that is ultimately
delivered to the transducer 2716. In one exemplary embodiment, the
switch 2706 is a MOSFET, although other switches and switching
configurations are adaptable as well. The output of the switch 2706
is fed to a drive circuit 2708 that contains, for example, a phase
detecting PLL and/or a low-pass filter and/or a voltage-controlled
oscillator. The output of the switch 2706 is sampled by the
processor 2702 to determine the voltage and current of the output
signal (labeled in FIG. 27 as AD2 V.sub.In and AD3 I.sub.In,
respectively). These values are used in a feedback architecture to
adjust the pulse width modulation of the switch 2706. For instance,
the duty cycle of the switch 2706 can vary from about 20% to about
80%, depending on the desired and actual output from the switch
2706.
[0257] The drive circuit 2708, which receives the signal from the
switch 2706, includes an oscillatory circuit that turns the output
of the switch 2706 into an electrical signal having a single
ultrasonic frequency, e.g., 55 kHz (referred to as VCO in FIG. 27).
As explained above, a smoothed-out version of this ultrasonic
waveform is ultimately fed to the transducer 902 to produce a
resonant sine wave along the waveguide 1502.
[0258] At the output of the drive circuit 2708 is a transformer
2710 that is able to step up the low voltage signal(s) to a higher
voltage. It is noted that all upstream switching, prior to the
transformer 2710, is performed at low (i.e., battery driven)
voltages, something that, to date, has not been possible for
ultrasonic cutting and cautery devices. This is at least partially
due to the fact that the device advantageously uses low
on-resistance MOSFET switching devices. Low on-resistance MOSFET
switches are advantageous, as they produce less heat than
traditional MOSFET device and allow higher current to pass through.
Therefore, the switching stage (pre-transformer) can be
characterized as low voltage/high current. In one exemplary
embodiment of the present invention, the transformer 2710 steps up
the battery voltage to 120V RMS. Transformers are known in the art
and are, therefore, not explained here in detail.
[0259] In each of the circuit configurations described and shown in
FIGS. 3-12, 16-21, and 27, circuit component degradation can
negatively impact the entire circuit's performance. One factor that
directly affects component performance is heat. Known circuits
generally monitor switching temperatures (e.g., MOSFET
temperatures). However, because of the technological advancements
in MOSFET designs, and the corresponding reduction in size, MOSFET
temperatures are no longer a valid indicator of circuit loads and
heat. For this reason, according to an exemplary embodiment, the
present invention senses with a sensing circuit 2714 the
temperature of the transformer 2710. This temperature sensing is
advantageous as the transformer 2710 is run at or very close to its
maximum temperature during use of the device. Additional
temperature will cause the core material, e.g., the ferrite, to
break down and permanent damage can occur. The present invention
can respond to a maximum temperature of the transformer 2710 by,
for example, reducing the driving power in the transformer 2710,
signaling the user, turning the power off completely, pulsing the
power, or other appropriate responses.
[0260] In one exemplary embodiment of the invention, the processor
2702 is communicatively coupled to the end effector 118, which is
used to place material in physical contact with the blade portion
116 of the waveguide 114, e.g., the clamping mechanism shown in
FIG. 1. Sensors are provided that measure, at the end effector, a
clamping force value (existing within a known range) and, based
upon the received clamping force value, the processor 2702 varies
the motional voltage V.sub.M. Because high force values combined
with a set motional rate can result in high blade temperatures, a
temperature sensor 2736 can be communicatively coupled to the
processor 2702, where the processor 2702 is operable to receive and
interpret a signal indicating a current temperature of the blade
from the temperature sensor 2736 and to determine a target
frequency of blade movement based upon the received
temperature.
[0261] According to an exemplary embodiment of the present
invention, the PLL 2708, which is coupled to the processor 2702, is
able to determine a frequency of waveguide movement and communicate
that frequency to the processor 2702. The processor 2702 stores
this frequency value in the memory 2726 when the device is turned
off. By reading the clock 2730, the processor 2702 is able to
determine an elapsed time after the device is shut off and retrieve
the last frequency of waveguide movement if the elapsed time is
less than a predetermined value. The device can then start up at
the last frequency, which, presumably, is the optimum frequency for
the current load.
[0262] XI. Battery Assembly--Mechanical
[0263] FIG. 28 shows the battery assembly 301 separate from the
handle assembly 302. The battery assembly 301 includes an outer
shell 2802 that, in the exemplary embodiment shown in FIG. 28,
includes a first half 2802a and a second half 2802b. There is,
however, no requirement that the shell 2802 be provided in two
identical halves. In accordance with an embodiment of the present
invention, when the outer shell 2802 is provided in two halves, the
first half 2802a can be ultrasonically welded to the second half
2802b in a clamshell configuration. Ultrasonically welding the two
halves of the shell 2802 eliminates the need for gaskets while
providing a "hermetic" seal between the components within the shell
2802 and the environment. A "hermetic" seal, as used herein,
indicates a seal that sufficiently isolates a compartment (e.g.,
interior of the shell 2802) and components disposed therein from a
sterile field of an operating environment into which the device has
been introduced so that no contaminants from one side of the seal
are able to transfer to the other side of the seal. This seal is at
least gas-tight, thereby preventing intrusion of air, water, vapor
phase H.sub.2O.sub.2, etc.
[0264] FIG. 28 also shows a multi-lead battery terminal assembly
2804, which is an interface that electrically couples the
components within the battery assembly 301 to an electrical
interface of the handle assembly 302. It is through the handle
assembly 302 that the battery assembly 301 is able to electrically
couple with the TAG assembly 303 of the present invention. As is
explained above, the battery assembly 301, through the multi-lead
battery terminal assembly 2804, provides power to the inventive
ultrasonic surgical cautery assembly 300, as well as other
functionality described herein. The multi-lead battery terminal
assembly 2804 includes a plurality of contacts pads 2806a-n, each
one capable of separately electrically connecting a terminal within
the battery assembly 301 to another terminal provided by a docking
bay (see FIG. 34) of the handle assembly 302. One example of such
electrical connections coupled to the plurality of contact pads
2806a-n is shown in FIG. 6 as power and communication signal paths
601a-n. In the exemplary embodiment of the multi-lead battery
terminal assembly 2804, sixteen different contact pads are shown.
This number is merely illustrative.
[0265] FIG. 29 provides a view of the underside of the multi-lead
battery terminal assembly 2804. In this view, it can be seen that
the plurality of contact pads 2806a-n of the multi-lead battery
terminal assembly 2804 include a corresponding plurality of
interior contact pins 2906a-n. Each contact pin 2906 provides a
direct electrical coupling to a corresponding one of the contact
pads 2806.
[0266] In the particular embodiment shown in FIGS. 28-33, the
multi-lead battery terminal assembly 2804 is potted between the
clam shell halves 2802a and 2802b of the shell 2802. More
particularly, FIG. 29 provides a view of the multi-lead battery
terminal assembly 2804 positioned inside an upper portion of the
first shell half 2802a of the battery assembly 301. As is shown in
the figure, an upper portion of the first shell half 2802a forms a
mouth 2902 that accepts an outer peripheral edge 2904 of the
multi-lead battery terminal assembly 2804.
[0267] FIG. 30 provides an additional view of the interior of the
first shell half 2802a with the multi-lead battery terminal
assembly 2804 inserted within the mouth 2902 of the first shell
half 2802a and a first circuit board 3002 having a plurality of
contact pads 3006 coupled to the contact pins 2906 of the
multi-lead battery terminal assembly 2804. The battery assembly
301, according to exemplary embodiments of the present invention,
includes, as is shown in FIG. 31, in addition to the first circuit
board 3002, additional circuit boards 3102 and 3104.
[0268] In accordance with one exemplary embodiment of the present
invention, the multi-lead battery terminal assembly 2804 comprises
a flex circuit that converts the illustrated 4.times.4 array of
contact pads 2006a-n to two 1.times.8 arrays of conductors that are
coupled to one or more of the circuit boards 3002, 3102, 3104.
[0269] Further, more than or less than three circuit boards is
possible to provide expanded or limited functionality. According to
exemplary embodiments of the present invention, each circuit board
3002, 3102, and 3104 provides a specific function. For instance,
circuit board 3002 can provide the components for carrying out the
battery protection circuitry 702 shown in FIG. 7. Similarly, the
circuit board 3102 can provide the components for carrying out the
battery controller 703, also shown in FIG. 7. The circuit board
3104 can, for example, provide high power buck controller
components. Finally, the battery protection circuitry 702 can
provide connection paths for coupling the battery cells 701a-n
shown in FIGS. 7 and 31.
[0270] Another advantage of a removable battery assembly 301 is
realized when lithium-ion (Li) batteries are used. As previously
stated, lithium batteries should not be charged in a parallel
configuration of multiple cells. This is because, as the voltage
increases in a particular cell, it begins to accept additional
charge faster than the other lower-voltage cells. Therefore, each
cell must be monitored so that a charge to that cell can be
controlled individually. When a lithium battery is formed from a
group of cells 701a-n, a multitude of wires extending from the
exterior of the device to the batteries 701a-n is needed (at least
one additional wire for each battery cell beyond the first). By
having a removable battery assembly 301, each battery cell 701a-n
can, in one exemplary embodiment, have its own exposed set of
contacts and, when the battery assembly 301 is not present inside
the handle assembly 302, each set of contacts can be coupled to a
corresponding set of contacts in an external, non-sterile,
battery-charging device. In another exemplary embodiment, each
battery cell 701a-n can be electrically connected to the battery
protection circuitry 702 to allow the battery protection circuitry
702 to control and regulate recharging of each cell 701a-n.
[0271] Turning now to FIG. 33, at least one additional novel
feature of the present invention is clearly illustrated. The
battery assembly 301 shown in FIG. 33 illustrates a fully assembled
battery assembly 301 that has been, for instance, ultrasonically
welded so that the two shell halves 2802a and 2802b, as well as the
potted multi-lead battery terminal assembly 2804, provide a
hermetic seal between the environment and the interior of the
battery assembly 301. Although shown in several of the previous
drawings, FIG. 33 illustrates an inventive catch 3300, which is
formed by an extended portion of the shell 2802 that is shaped by a
general longitudinal void 3302 directly under the catch 3300, both
being located at an upper portion of the exterior of the shell
2802. The catch 3300 is shaped to mate with a receiver 3400 in a
lower battery dock 3401 of the handle assembly 302, which is shown
in FIG. 34.
[0272] FIG. 35 illustrates an underside of the handle assembly 302
and provides an improved view of the receiver 3400 and the battery
dock 3401. As is can be seen in FIG. 35, the receiver 3400 extends
from the battery dock 3401 (formed by a handle shell 3500) and is
shaped to mate with, i.e., fit within, the void 3302 of the battery
assembly 301. In addition, the receiver 3400 is in close proximity
to a multi-lead handle terminal assembly 3502, which includes a
plurality of handle-connection pins 3504a-n. In the exemplary
embodiment shown in FIG. 35, each handle contact pin in the
multi-lead handle terminal assembly 3502 is a spring-type contact
pin that is capable of being compressed while exerting an amount of
force in a direction opposite the compression force and, thereby,
maintaining a positive electrical connection between the
handle-connection pin 3504a-n and the object applying the force. In
addition, the handle-connection pins 3504a-n of the multi-lead
handle terminal assembly 3502 are spaced so that each of the
handle-connection pins 3504a-n physically aligns with a respective
one of the contact pads 2806a-n of the multi-lead battery terminal
assembly 2804.
[0273] To couple the inventive battery assembly 301 to the
inventive handle assembly 302, the catch 3300 is contacted with the
receiver 3400, as is shown in FIG. 36, and the battery assembly 301
is rotated with respect to the handle assembly 302, as is shown in
the progression from FIG. 36 to FIG. 37. Although not limited to
the exemplary embodiments shown in the figures of the instant
specification, the physical shapes of the catch 3300 and receiver
3400 shown in FIGS. 33-35 (particularly the rounded corners 3305
shown in FIG. 33) cause the battery assembly 301 to align itself
with the handle assembly 302 virtually regardless of the angle to
which the battery assembly 301 approaches the receiver 3400, as
long as the catch 3300 and receiver 3400 are in physical contact
with each other. With any rotation of the battery assembly 301
between the position shown in FIG. 36 and the position shown in
FIG. 37, the catch 3300, or rather, the void 3302, automatically
seats upon the receiver 3400. This means that a user in the sterile
field can easily connect the battery assembly 301 to the handle
assembly 302 and, especially, can do so without actually viewing
the two parts during connection efforts.
[0274] In accordance with one exemplary embodiment of the present
invention, the multi-lead handle terminal assembly 3502, as shown
in FIG. 35, includes a gasket 3512 that surrounds the
handle-connection pins 3504a-n and is sealed to a flex circuit
board 3514 that supports the handle-connection pins 3504a-n. In one
exemplary embodiment, the gasket 3512 is part of a rigid-flex
circuit that includes the flex circuit board 3514 as well as the
handle-connection pins 3504a-n. A portion of the flex circuit board
3514 can be made relatively rigid or stiffer as compared to the
rest of the flex circuit board 3514. When the gasket 3512 is
compressed during connection of the battery assembly 301 to the
handle assembly 302, rigid portions of the flex circuit board 3514
adjacent the gasket 3512 support the gasket 3512 and allow the
gasket 3512 to be compressed without substantial movement when the
battery assembly 301 is coupled to the handle assembly 302. When
the multi-lead battery terminal assembly 2804 and the multi-lead
handle terminal assembly 3502 are placed together, as shown in
FIGS. 59 and 60, a seal exists between an outer periphery 3312 of
the multi-lead battery terminal assembly 2804 and the gasket 3512
of the multi-lead handle terminal assembly 3502. The seal prevents
moisture from penetrating the interior of the gasket 3512, i.e.,
reaching the handle-connection pins 3504a-n of the multi-lead
handle terminal assembly 3502 or the contacts pads 2806a-n of the
multi-lead battery terminal assembly 2804.
[0275] As shown in FIG. 56 and explained in detail below, the
rigid-flex circuit of the handle assembly 302 electrically couples
the handle-connection pins 3504a-n to the handle assembly's TAG
electrical connector 5602.
[0276] Referring briefly back to FIG. 35, the handle body 3500 of
the handle assembly 302 is provided with an extended battery
securing portion 3506. The extended battery securing portion 3506
is on a side of the multi-lead handle terminal assembly 3502
opposite the receiver 3400. It is noted that the particular
exemplary embodiment of the handle-securing portion shown in FIG.
35 includes a pair of voids 3508 and 3510, which are not necessary
to complete the battery-handle securing process. Referring now to
FIG. 38, an additional feature of the battery assembly 301 is
shown. In this view, a pair of bosses 3802, 3804 can be seen on an
exterior side of the battery assembly shell 2802. The bosses 3802,
3804 are spaced and positioned to mate with the voids 3508, 3510 in
the extended battery securing portion 3506 of the handle body 3500.
This mating position is illustrated in FIG. 37. Referring still to
FIG. 38, it can be seen that each of the bosses 3802, 3804 are
provided with a sloped upper portion 3816 and an opposing
sharp-edge bottom portion 3818. The sloped upper portion 3816
allows the bosses 3802, 3804 to easily slip into the voids 3508,
3510 in the extended battery securing portion 3506 of the handle
assembly 302 when the battery assembly 301 is being secured to the
handle assembly 302. The sharp-edge bottom portions 3818 secure and
allow the bosses 3802, 3804 to remain seated within the extended
battery securing portion 3506 of the handle assembly 302.
[0277] The combination of the mating between the catch 3300 and
receiver 3400 at one side of the battery assembly 301 and the
mating between the bosses 3802, 3804 and the voids 3508, 3510,
respectively, at the other side of the battery assembly 301
provides a solid and secure attachment of the battery assembly 301
to the handle assembly 302 (see also FIGS. 3 and 37). In an
exemplary embodiment, the two bosses 3802, 3804 are spaced as far
apart from each other as is practical. This spacing improves
stability of the attachment between the battery assembly 301 and
the handle assembly 302.
[0278] FIG. 38 also illustrates a release mechanism 3806 coupled to
the exterior of the battery assembly shell 2802. The release
mechanism 3806 is provided with peripheral edges 3808 that are
secured by and slide within a pair of corresponding channels 3810,
3812 formed within the same exterior side of the battery assembly
shell 2802 as the bosses 3802, 3804. The release mechanism 3806 has
a sloped nose region 3814 that is operable for moving toward and
away from the bosses 3802 and 3804 and, in the particular
embodiment shown in FIG. 38, extends between the bosses 3802 and
3804 when the release mechanism 3806 is slid in an upwardly
direction.
[0279] When the battery assembly 301 is securely coupled to the
handle assembly 302, as is shown in FIG. 37, the release mechanism
3806 remains in a position within the channels 3810, 3812 that is
furthest away from the handle assembly 302. When a user desires to
remove the battery assembly 301 from the handle assembly 302, the
release mechanism 3806 is slid within the channels 3810, 3812 in a
direction toward the handle assembly 302. This sliding action
causes the sloped nose region 3814 to enter the area between the
battery assembly 301 and the lowermost portion of the extended
battery securing portion 3506. As the sloped nose region 3814 moves
forward, the extended battery securing portion 3506 rides up the
sloped nose region 3814 and flexes away from the battery assembly
301. Stated differently, the extended battery securing portion 3506
bends away from the multi-lead handle terminal assembly 3502 and
receiver 3400.
[0280] Once the extended battery securing portion 3506 flexes to a
certain degree, the bottom edges 3802a-3802b of the bosses 3802 and
3804 no longer engage with the voids 3508 and 3510 and the battery
assembly 301 can easily be rotated from the orientation shown in
FIG. 37 to that shown in FIG. 36 and, ultimately, separated from
the handle assembly 302. The release mechanism 3806 is, of course,
only one example of a mechanism that secures the battery assembly
301 to and releases the battery assembly 301 from the handle
assembly 302. The release mechanism 3806 is advantageous in that it
renders unintended detachment very unlikely. To release the battery
assembly 301, an operator needs to move the release mechanism 3806
toward the handle while, at the same time, rotating the battery
assembly 301 away from the handle assembly 302. These two
oppositely-directed forces/actions are very unlikely to occur
simultaneously unless they are performed intentionally. Application
of these different forces also requires the user's hands to be in a
position different than an in-use position during surgery. Such a
configuration virtually ensures that accidental separation of the
battery assembly 301 and handle assembly 302 does not occur.
[0281] The present invention also provides a significant advantage
over prior art devices in the way the electrical connection between
the multi-lead handle terminal assembly 3502 and the multi-lead
battery terminal assembly 2804 is formed. More specifically,
looking again to FIG. 33, it can be seen that, in the illustrated
exemplary embodiment of the multi-lead battery terminal assembly
2804, sixteen contact pads 2806 are present--the contact pads
2806a-d forming a first row 3304, contact pads 2806e-h forming a
second row 3306, contact pads 2806i-1 forming a third row 3308, and
contact pads 2806m-p forming a fourth row 3310.
[0282] Similarly, as is shown in FIGS. 34 and 35, the multi-lead
handle terminal assembly 3502 includes a plurality of
handle-connection pins 3504a-n (only twelve of the sixteen pins
3504a-n are shown in the view of FIG. 35). The handle contact pins
are configured so that, when the battery assembly 301 is coupled to
the handle assembly 302, each handle-connection pin 3504a-n is
aligned with an individual one of the contact pads 2806. Therefore,
the handle-connection pins 3504a-n are also disposed, in the
particular embodiment shown in the drawings, in four rows 3404,
3406, 3408, and 3410.
[0283] When the battery assembly 301 is to be attached to the
handle assembly 302, the catch 3300 is first placed in contact with
the receiver 3400 and the battery assembly 301 is then rotated
toward the extended battery securing portion 3506 until the bosses
3802, 3804, respectively, engage the voids 3508, 3510 in the
extended battery securing portion 3506. One significant result of
the rotation is that the physical/electrical connection between the
multi-lead handle terminal assembly 3502 and the multi-lead battery
terminal assembly 2804 occurs sequentially, one row at a time,
starting with battery row 3304 and handle row 3404.
[0284] According to an exemplary embodiment of the present
invention, the first battery row 3304 includes a grounding contact
pad and the last battery row 3410 includes at least one power
contact pad. Therefore, the first contact between the multi-lead
battery terminal assembly 2804 and the multi-lead handle terminal
assembly 3502 is a grounding connection and the last is the power
connection. Installation of the battery assembly 301 will not cause
a spark because the ground contact of the battery assembly 301 is a
distance away from the last row 3410 of the multi-lead handle
terminal assembly 3502 when the powered connection is made. As the
battery assembly 301 is rotated into an attachment position (shown
in FIG. 37), each battery row 3304, 3306, 3308, 3310 sequentially
makes contact with each handle row 3404, 3406, 3408, 3410,
respectively, but the power contact(s) is(are) only connected after
a row having at least one grounding contact has been connected. In
other words, as the battery assembly 301 is installed into the
handle assembly 302, the battery assembly 301 is advantageously
grounded before any power contacts are brought into contact with
any portion of the handle assembly 302--a significant advantage
over prior-art device power supply couples. In all known devices,
the contacts supplying power (i.e., electric mains) are coupled
simultaneous to other couplings, or randomly, depending on the
approach orientation of the electric plug. This prior-art coupling
leaves sparking or arcing as a persistent possibility. With the
present invention, however, the possibility of sparking or arcing
that is present in the prior art is entirely eliminated.
[0285] In addition, in accordance with one exemplary embodiment of
the present invention, one or more pins in any of the first, 3404,
the second 3406, the third 3408, or the last row 3410 of the
handle-connection pins 3504a-n are coupled to a battery presence
detection circuit 3104. In particular, one of the contacts in the
last row 3410 is used as a present pad. The battery presence
detection circuit 3104, after detecting the proper connection of
the grounding pin(s) and the present pin of the multi-lead handle
terminal assembly 3502 to the multi-lead battery terminal assembly
2804, allows operation of the ultrasonic surgical assembly 300. In
the embodiment where the battery present detection pad(s) is/are
only in the last row, i.e., furthest away from the receiver 3400,
the handle assembly 302 will not alter/change states until the
battery assembly 301 is fully and securely installed, i.e., all
contacts are properly connected. This advantageous feature prevents
any improper operation of the overall assembly. Similarly, when
disconnecting the battery assembly 301, the last row 3410 is the
first row disconnected from the handle-connection pins 3504a-n.
Therefore, the device immediately responds to the absence of the
battery assembly 301 from the handle assembly 302.
[0286] In the exemplary embodiment, the battery protection circuit
702, i.e., the fuel gauge, monitors the present pad and waits for
it to be grounded before powering the microprocessor 1006 within
the TAG assembly 303. To do this, of course, the TAG assembly 303
must also be coupled to the handle assembly 302. More particularly,
the TAG assembly 303 must be electrically coupled to the handle
assembly's TAG electrical connector 5602. Once the TAG assembly 303
is coupled to the handle assembly's TAG electrical connector 5602
(see, e.g., FIGS. 36 and 37) and the battery assembly 301 is
properly coupled to the multi-lead handle terminal assembly 3502
(see, e.g., the configuration shown in FIG. 37), communication
between the battery assembly 301 and the TAG assembly 302 occurs.
After such communication is established, the device is ready for
use and the battery controller 703 can signal a "ready-for-use"
state to the user, for example, by generating an indicative tone at
the buzzer 802 within the handle assembly 302 and/or generating a
visual indicator at the LEDs 906.
[0287] In one exemplary embodiment for establishing this
communication, the battery protection circuit 702 senses the
presence of a proper connection between the battery assembly 301
and the handle assembly 302 by periodically pulsing a low-voltage
signal to the present pad. The battery protection circuit 702
monitors the present pad for a connection to ground, which ground
is provided by the handle assembly 302 once the battery assembly
301 is properly connected thereto. However, because the battery
assembly 301 may be submerged in a solution, for example, water
during cleaning, it is advantageous for the battery assembly 301
not to sense a false ground condition as if the battery assembly
301 has been properly connected to the handle assembly 301 when the
ground condition is only due to the solution electrically coupling
the present pad to ground. For this reason, embodiments of the
present invention provide a comparator that monitors the impedance
between the present pad and ground. The comparator compares the
impedance of a coupling between the present pad and ground to the
reference impedance so that only when the impedance is less than a
threshold impedance, i.e., less than that of a solution, will the
battery assembly 301 operate.
[0288] The illustrated design of the multi-lead handle terminal
assembly 3502 provides even further advantages over the prior art.
In particular, the inventive handle-connection pins 3504a-n, shown
in the enlarged partial perspective view of FIG. 39, provide a
physical connection along with a lateral displacement that ensures
removal of any foreign substances from the contact region where the
handle-connection pins 3504a-n of the multi-lead handle terminal
assembly 3502 meet the contact pads 2806a-n of the multi-lead
battery terminal assembly 2804. Specifically, FIG. 39 shows the
first handle-connection pin 3504a in its at-rest, non-contact
state. That is, the handle-connection pin 3504a has a spring force
that places and retains it in the natural resting shape shown in
FIG. 39. However, when the multi-lead battery terminal assembly
2804 is fully mated with the multi-lead handle terminal assembly
3502, the handle-connection pins 3504a-n compress. This compressed
state is shown, for example, by handle-connection pins 3504b and
3504f in FIG. 39.
[0289] The compression placed on the handle-connection pin 3504a-n
by the contact pad 2806 not only provides positive pressure to
retain the electrical connection, but also causes the connecting
surface of each handle-connection pin 3504a-n to move a distance D
with respect to the longitudinal extent of the pin 3504. This
distance D is illustrated in FIG. 39 by a first line 3901 showing
where an apex of a connecting surface of a first handle-connection
pin 3504e exists when the pin 3504e is in its uncompressed state. A
second line 3902 shows where the apex of the connecting surface of
the neighboring second handle-connection pin 3504f exists when the
pin 3504f is compressed. The difference between the two lines
defines a longitudinal distance D that the connecting surface of
each pin 3504a-n translates when compressed. This movement is
initiated when the handle-connection pin 3504a-n and the respective
contact pad 2806 first make contact and continues until the battery
assembly 301 is fully seated between the receiver 3400 and the
extended battery securing portion 3506, as shown in the cutaway
perspective view FIG. 40. The translation movement of the
handle-connection pins 3504a-n produces a swiping motion that
effectively wipes the contact pad 2806 clean, thus improving
electrical connection therebetween. This wiping effect can prove
highly advantageous when, for instance, a battery needs to be
replaced in an operating environment and material, such as blood,
comes into contact with the contact pads 2806 or when the pads are
corroded from repeated use or due to exposure to cleaning
agents.
[0290] The view of FIG. 39 shows yet another advantageous feature
of the present invention. In FIG. 39, it can be seen that the
multi-lead handle terminal assembly 3502 features flanged sides
3904 that protect the handle-connection pins 3504a-n of the handle
assembly 302.
[0291] A further advantage of the present invention is that the
entire battery assembly 301 can be sterilized. If there is a need
for replacement during a medical procedure, the battery assembly
can be easily replaced with a new sterile battery assembly. The
gas-tight construction of the battery assembly 301 allows it to be
sterilized, for example, using low-temperature vapor phase Hydrogen
Peroxide (H.sub.2O.sub.2) as performed by the sterilization devices
manufactured by the Steris Corporation and referred to under the
trade name V-PRO or manufactured by Advanced Sterilization Products
(ASP), division of Ethicon, Inc., a Johnson & Johnson company,
and referred to under the trade name STERRAD.RTM.. Because the
Lithium cells of the battery assembly 301 are damaged when heated
above 60.degree. C., non-heating sterilization commonly used in
hospitals today makes the battery assembly 301 easily re-used in
surgical environments.
[0292] a. Battery Pressure Valve
[0293] The battery assembly 301 of the present invention features
yet another inventive feature. As shown in FIG. 37, the battery
assembly 301 includes a pressure valve 3702 that, as will be
explained below, prevents the influence of external atmospheric
pressure--both positive and negative--on the battery assembly's
internal pressure, while providing for emergency pressure relief
for excess internal pressure, e.g., >30 psi. This valve 3702,
advantageously, has a large enough opening to vent any internally
accumulating gases quickly. Also advantageously, the inventive
valve 3702 does not instantaneously open and close with small
changes in pressure, as do some prior art venting devices. Instead,
the opening and closing events of the valve 3702 have several
defined stages. In an exemplary configuration of the valve 3702,
during the first stage (<30 psi), the valve 3702 remains sealed,
as shown in FIGS. 41 and 42, and does not allow gas flow into or
out of the battery compartment. This exemplary embodiment can be
referred to as a so-called poppet valve. In stage 2, once pressure
has increased just enough to counter the force of a spring 4102
holding an O-ring 4104 surrounding a poppet 4106 against a valve
seat 4202, shown in the cutaway view of FIG. 42, fluid/gas will
begin to escape between the O-ring 4104 and the seat 4202. In stage
3, pressure has pushed the valve 3702 open enough to allow a
significant amount of fluid/gas to pass the seal 4104, 4202. This
is enough to measure accurately. At this point, and up to stage 4,
internal pressure has forced the valve completely open, i.e., the
O-ring 4104 has moved completely off of the seat 4202. Additional
pressure has diminished effect on the flow because the valve cannot
open further.
[0294] In stage 5, pressure on the valve 3702 begins to decrease
and the poppet 4106 starts to shut. As the poppet 4106 retracts, it
follows the same sequence as occurred during opening through
hysteresis (i.e., retardation of an effect when forces acting upon
a body are changed, dictating that a lag in closing occurs). As a
result, when the poppet 4106 begins its return, it lags in position
relative to the curve of FIG. 44 traversed when the poppet 4106 was
opening. At stage 6, the O-ring 4104 just touches the seat 4202.
The valve does not seal at this point, as there is no force
pressing the O-ring 4104 into the seat 4202. In step 7, the force
of the spring 4102 compresses the O-ring 4104 with sufficient force
to seal the valve shut. The valve 3702 can now return to stage 1,
shown in FIGS. 41 and 42. For ease of testing the valve 3702, the
poppet 4106 is formed with a tear-off handle 4108. In this
exemplary configuration, a user or leak-testing fixture can grasp
the handle 4108 and move the poppet 4106 out and back within the
valve dock 4204, here, shown located in one half of the outer shell
2802a or 2802b of the battery assembly 301. When testing is
finished, the user, for example, the manufacturer, can tear off or
otherwise remove the handle 4108 to prevent further user-controlled
poppet 4106 movement. Removal of the handle 4108 is made easier
with a narrowing 4110 formed at the base of the handle 4108.
[0295] b. Smart Battery
[0296] In additional exemplary embodiments of the present
invention, a smart battery is used to power the surgical ultrasonic
surgical cautery assembly 300. However, the smart battery is not
limited to the ultrasonic surgical cautery assembly 300 and, as
will be explained, can be used in a variety of devices, which may
or may not have power requirements (i.e., current and voltage) that
vary from one another. The smart battery, in accordance with an
exemplary embodiment of the present invention, is advantageously
able to identify the particular device to which it is electrically
coupled. It does this through encrypted or unencrypted
identification methods. For instance, a battery assembly 301 shown
in FIG. 57 can have a connection portion, such as portion 5702. The
handle assembly 302 can also be provided with a device identifier
5704 communicatively coupled to the multi-lead handle terminal
assembly 3502 and operable to communicate at least one piece of
information about the handle assembly 302. This information can
pertain to the number of times the handle assembly 302 has been
used, the number of times a TAG assembly 303 (presently connected
to the handle assembly 302) has been used, the number of times a
waveguide assembly 304 (presently connected to the handle assembly
302) has been used, the type of waveguide assembly 304 that is
presently connected to the handle assembly 302, the type or
identity of the TAG assembly 303 that is presently connected to the
handle assembly 302, or many other characteristics. When the smart
battery assembly 301 is inserted in the handle assembly 302, the
connection portion 5702 within the smart battery assembly 301 makes
communicating contact with the device identifier 5704 of the handle
assembly 302. The handle assembly 302, through hardware, software,
or a combination thereof, is able to transmit information to the
smart battery assembly 301 (whether by self-initiation or in
response to a request from the battery assembly 301). This
communicated identifier is received by the connection portion 5702
of the smart battery assembly 301. In one exemplary embodiment,
once the smart battery assembly 301 receives the information, the
communication portion 5702 is operable to control the output of the
battery assembly 301 to comply with the device's specific power
requirements.
[0297] In an exemplary embodiment, the communication portion 5702
includes a processor, such as processor 1118, and a memory, which
may be separate or a single component. The processor 1118, in
combination with the memory, is able to provide intelligent power
management for the handheld ultrasonic surgical cautery assembly
300. This embodiment is particularly advantageous because an
ultrasonic device, such as handheld ultrasonic surgical cautery
assembly 300, has a power requirement (frequency, current, and
voltage) that may be unique to the handheld ultrasonic surgical
cautery assembly 300. In fact, handheld ultrasonic surgical cautery
assembly 300 may have a particular power requirement or limitation
for one dimension or type of waveguide 1502 and a second different
power requirement for a second type of waveguide having a different
dimension, shape, and/or configuration.
[0298] A smart battery 301 according to the invention, therefore,
allows a single battery assembly to be used amongst several
surgical devices. Because the smart battery 301 is able to identify
to which device it is attached and is able to alter its output
accordingly, the operators of various different surgical devices
utilizing the smart battery 301 no longer need be concerned about
which power source they are attempting to install within the
electronic device being used. This is particularly advantageous in
an operating environment where a battery assembly needs to be
replaced in the middle of a complex surgical procedure.
[0299] In a further exemplary embodiment, the smart battery 301
stores in a memory 5706 a record of each time a particular device
is used. This record can be useful for assessing the end of a
device's useful or permitted life. For instance, once a device is
used 20 times, all such batteries 301 connected to the device will
refuse to supply power thereto--because the device is defined as a
"no longer reliable" surgical instrument. Reliability is determined
based on a number of factors. One factor can be wear--after a
certain number of uses, the parts of the device can become worn and
tolerances between parts exceeded. For instance, the smart battery
301 can sense the number of button pushes received by the handle
assembly 302 and can determine when a maximum number of button
pushes has been met or exceeded. The smart battery 301 can also
monitor an impedance of the button mechanism which can change, for
instance, if the handle gets contaminated, for example, with
saline.
[0300] This wear can lead to an unacceptable failure during a
procedure. In some exemplary embodiments, the smart battery 301 can
recognize which parts are combined together in a device and even
how many uses each part has experienced. For instance, looking at
FIG. 57, if the battery assembly 301 is a smart battery according
to the invention, it can identify both the handle assembly 302, as
well as the particular TAG assembly 303, well before the user
attempts use of the composite device. The memory 5706 within the
smart battery 301 can, for example, record each time the TAG
assembly 303 is operated. If each TAG assembly 303 has an
individual identifier, the smart battery 301 can keep track of each
TAG assembly's use and refuse to supply power to that TAG assembly
303 once the handle assembly 302 or the TAG assembly 303 exceeds
its maximum number of uses. The TAG assembly 303, the handle
assembly 302, or other components can include a memory chip that
records this information as well. In this way, any number of smart
batteries 301 can be used with any number of TAG assemblies,
staplers, vessel sealers, etc. and still be able to determine the
total number of uses, or the total time of use (through use of the
clock 330), or the total number of actuations, etc. of each TAG
assembly, each stapler, each vessel sealer, etc. or charge or
discharge cycles.
[0301] In some exemplary embodiments, the smart battery 301 can
communicate to the user through audio and/or visual feedback. For
example, the smart battery 301 can cause the LEDs 906 to light in a
pre-set way. In such a case, even though the microcontroller 1006
in the generator 904 controls the LEDs 906, the microcontroller
1006 receives instructions to be carried out directly from the
smart battery 301.
[0302] In yet a further exemplary embodiment, the microcontroller
1006 in the generator 904, when not in use for a predetermined
period of time, goes into a sleep mode. Advantageously, when in the
sleep mode, the clock speed of the microcontroller 1006 is reduced,
cutting the current drain significantly. Some current continues to
be consumed, because the processor continues pinging waiting to
sense an input. Advantageously, when the microcontroller 1006 is in
this power saving sleep mode, the microcontroller 1106 and the
battery controller 703 can directly control the LEDs 906. This is a
power-saving feature that eliminates the need for waking up the
microcontroller 1006. Another exemplary embodiment slows down one
or more of the microcontrollers to conserve power when not in use.
For example, the clock frequencies of both microcontrollers can be
reduced to save power. To maintain synchronized operation, the
microcontrollers coordinate the changing of their respective clock
frequencies to occur at about the same time, both the reduction
and, then, the subsequent increase in frequency when full speed
operation is required. For example, when entering the idle mode,
the clock frequencies are decreased and, when exiting the idle
mode, the frequencies are increased.
[0303] In an additional exemplary embodiment, the smart battery 301
is able to determine the amount of usable power left within its
cells 701 and is programmed to only operate the surgical device to
which it is attached if it determines there is enough battery power
remaining to predictably operate the device throughout the
anticipated procedure. For example, the smart battery 301 is able
to remain in a non-operational state if there is not enough power
with the cells 701 to operate the surgical device for 20 seconds.
According to one exemplary embodiment, the smart battery 301
determines the amount of power remaining within the cells 701 at
the end of its most recent preceding function, e.g., a surgical
cutting. In this embodiment, therefore, the battery assembly 301
would not allow a subsequent function to be carried out if, for
example, during that procedure, it determines that the cells 701
have insufficient power. Alternatively, if the smart battery 301
determines that there is sufficient power for a subsequent
procedure and goes below that threshold during the procedure, it
would not interrupt the ongoing procedure and, instead, will allow
it to finish and thereafter prevent additional procedures from
occurring.
[0304] The following explains an advantage of the invention with
regard to maximizing use of the device with the smart battery 301
of the invention. Take an example where a set of different devices
have different waveguides. By definition, each of the waveguides
could have a respective maximum allowable power limit where
exceeding that power limit overstresses the waveguide and
eventually causes it to fracture. One waveguide from the set of
waveguides will naturally have the smallest maximum power
tolerance. Because prior-art batteries lack intelligent battery
power management, the output of prior-art batteries must be limited
by a value of the smallest maximum allowable power input for the
smallest/thinnest/most-frail waveguide in the set that is
envisioned to be used with the device/battery. This would be true
even though larger, thicker waveguides could later be attached to
that handle and, by definition, allow a greater force to be
applied. This limitation is also true for maximum battery power.
For example, if one battery is designed to be used in multiple
devices, its maximum output power will be limited to the lowest
maximum power rating of any of the devices in which it is to be
used. With such a configuration, one or more devices or device
configurations would not be able to maximize use of the battery
because the battery does not know the particular device's specific
limits.
[0305] In contrast thereto, exemplary embodiments of the present
invention utilizing the smart battery 301 are able to intelligently
circumvent the above-mentioned prior art ultrasonic device
limitations. The smart battery 301 can produce one output for one
device or a particular device configuration and the same battery
assembly 301 can later produce a different output for a second
device or device configuration. This universal smart battery
surgical system lends itself well to the modern operating room
where space and time are at a premium. By having a single smart
battery pack operate many different devices, the nurses can easily
manage the storage, retrieval, and inventory of these packs.
Advantageously, the smart battery system according to the invention
requires only one type of charging station, thus increasing ease
and efficiency of use and decreasing cost of surgical room charging
equipment.
[0306] In addition, other devices, such as an electric stapler, may
have a completely different power requirement than that of the
ultrasonic surgical cautery assembly 300. With the present
invention, a single smart battery 301 can be used with any one of
an entire series of surgical devices and can be made to tailor its
own power output to the particular device in which it is installed.
In one exemplary embodiment, this power tailoring is performed by
controlling the duty cycle of a switched mode power supply, such as
buck, buck-boost, boost, or other configuration, integral with or
otherwise coupled to and controlled by the smart battery 301. In
other exemplary embodiments, the smart battery 301 can dynamically
change its power output during device operation. For instance, in
vessel sealing devices, power management is very important. In
these devices, large constant current values are needed. The total
power output needs to be adjusted dynamically because, as the
tissue is sealed, its impedance changes. Embodiments of the present
invention provide the smart battery 301 with a variable maximum
current limit. The current limit can vary from one application (or
device) to another, based on the requirements of the application or
device.
[0307] XII. Handle Assembly--Mechanical
[0308] FIG. 45 illustrates an exemplary embodiment of a right-hand
side of the handle portion 302 with the left shell half removed.
The handle assembly 302 has four basic functions: (1) couple the
battery assembly 301 to the multi-lead handle terminal assembly
3502; (2) couple the TAG assembly 303 to a TAG attachment dock
4502; (3) couple the ultrasonic cutting blade and waveguide
assembly 304 to a waveguide attachment dock 4504; and (4) provide
the triggering mechanics 4506 to operate the three components
(battery assembly 301, TAG assembly 303, and ultrasonic cutting
blade and waveguide assembly 304).
[0309] a. TAG Attachment Dock
[0310] The TAG attachment dock 4502 is exposed to the environment
and shaped to interchangeably secure the TAG assembly 303 to the
handle assembly 302. The waveguide attachment dock 4504 is shaped
to align a proximal end of the waveguide 1502 to the transducer
902. When the transducer 902 is docked in the TAG attachment dock
4502 and the waveguide assembly 304 is docked in the waveguide
attachment dock 4504, and the transducer 902 and waveguide 1502 are
attached together, the waveguide 1502 and the transducer 902 are
held at the handle assembly 302 in a freely rotatable manner.
[0311] As can be seen in FIGS. 45 and 46, the handle assembly 302
includes two clamshell-connecting body halves, the right half 4503
being shown in FIG. 45 and the left half being shown in FIG. 46.
The two halves 4503, 4603 form at least a portion of the waveguide
attachment dock 4504, which can be considered as being exposed to
the environment when the waveguide rotation spindle 3704 is not
present. A first couple 4602 is operable to selectively removably
secure the ultrasonic waveguide assembly 304 to the handle assembly
302. In the exemplary embodiment shown, the spindle 3704 has an
intermediate annular groove 4603 shaped to receive an annular boss
4605. When the two halves 4503, 4603 are connected, the groove 4603
and boss 4605 form a longitudinal connection of the waveguide
assembly 304 that is free to rotate.
[0312] The TAG attachment dock 4502 opposes the waveguide
attachment dock 4504. The TAG attachment dock 4502 is exposed to
the environment and has a second couple 4604 operable to removably
secure the ultrasonic transducer 902 to the ultrasonic waveguide
1502 when the ultrasonic waveguide assembly 304 is coupled to the
waveguide attachment dock 4504. The couples 4602 and 4604 can
simply be aligned passageways or any other structure that place the
waveguide 1502 into axial alignment with the transducer 902. Of
course, the couples 4602 and 4604 can provide more structure, such
as threads, that actually hold the waveguide 1502 and/or transducer
902 to the handle or to one another.
[0313] b. Controls
[0314] Looking now to FIG. 46, a trigger 4606 and a button 4608 are
shown as components of the handle assembly 302. The trigger 4606
activates the end effector 118, which has a cooperative association
with the blade portion 116 of the waveguide 114 to enable various
kinds of contact between the end effector 118 and blade portion 116
with tissue and/or other substances. As shown in FIG. 1, the end
effector 118 is usually a pivoting jaw (see e.g., FIG. 73 et seq.)
that acts to grasp or clamp onto tissue disposed between the jaw
and the blade 116.
[0315] The button 4608, when depressed, places the ultrasonic
surgical assembly 300 into an ultrasonic operating mode, which
causes ultrasonic motion at the waveguide 1502. In a first
exemplary embodiment, depression of the button 4608 causes
electrical contacts within a switch 4702, shown in FIG. 47, to
close, thereby completing a circuit between the battery assembly
301 and the TAG assembly 303 so that electrical power is applied to
the transducer 902. In another exemplary embodiment, depression of
the button 4608 closes electrical contacts to the battery assembly
301. Of course, the description of closing electrical contacts in a
circuit is, here, merely an exemplary general description of switch
operation. There are many alternative embodiments that can include
opening contacts or processor-controlled power delivery that
receives information from the switch 4702 and directs a
corresponding circuit reaction based on the information.
[0316] FIG. 47 shows the switch 4702 from a left-side elevational
view and FIG. 48 provides a cutaway perspective view of the
interior of the handle body, revealing different detail of the
switch 4800. In a first embodiment, the switch 4800 is provided
with a plurality of contacts 4804a-n. Depression of a plunger 4802
of the switch 4702 activates the switch and initiates a switch
state change and a corresponding change of position or contact
between two or more of the plurality of contacts 4804a-n. If a
circuit is connected through the switch 4702, i.e., the switch 4702
controls power delivery to the transducer 902, the state change
will either complete or break the circuit, depending on the
operation mode of the switch 4702.
[0317] FIG. 49 shows an embodiment of the switch 4702 that provides
two switching stages. The switch 4702 includes two sub-switches
4902 and 4904. The sub-switches 4902 and 4904 advantageously
provide two levels of switching within a single button 4802. When
the user depresses the plunger 4802 inward to a first extent, the
first sub-switch 4902 is activated, thereby providing a first
switch output on the contacts 4804a-n (not shown in this view).
When the plunger 4802 is depressed further inward to a second
extent, the second sub-switch 4904 is activated, resulting in a
different output on the contacts 4804a-n. An example of this
two-stage switch 4702 in actual use would be for the TAG generator
904 to have two possible output power levels available, each
resulting in a different motion displacement value of the waveguide
1502. Activation of the first sub-switch 4902 can, for example,
initiate the first output power level from the generator 904 and
activation of the second sub-switch 4904 could result in a second
power level to be output from the generator 904. An exemplary
embodiment of this two stage switch 4702 provides a low-power level
for the first displacement and a high-power level for the second
displacement. Configuring the sub-switches 4902 and 4904 in a
stack, shown in FIG. 49, advantageously makes it easy and intuitive
for an operator to move from the first switch mode, i.e., first
power level, to the second switch mode, i.e., second power level,
by simply squeezing the plunger 4802 of the button 4702 with
increased force.
[0318] In one embodiment of the sub-switches 4902 and 4904, spring
force could be utilized, with each spring having a different
spring-force rating. When the plunger 4802 is initially depressed,
the first spring in the first sub-switch 4902 begins to compress.
Because a second spring located in the second sub-switch 4904 is
stiffer than the first spring, only the first sub-switch 4902 is
caused to change switching states. Once the first sub-switch 4902
is depressed a sufficient distance to change switching states,
further (greater) force applied to the plunger 4802 causes the
second stiffer spring to depress and the second sub-switch 4904 to
change states.
[0319] In practice, ultrasonic cutting devices, such as ones
employing the present invention, encounter a variety of tissue
types and sizes and are used in a variety of surgical procedure
types, varying from precise movements that must be tightly
controlled to non-delicate cutting material that requires less
control. It is therefore advantageous to provide at least two
ultrasonic cutting power levels that allow an operator to select
between a low-power cutting mode and a higher-power cutting mode.
For example, in the low-power cutting mode, i.e., only the first
sub-switch 4902 is depressed, the tip of the waveguide 1502 moves
at about 0.002 inches of displacement. In the higher-power cutting
mode, i.e., both the first and second sub-switches 4902 and 4904
are depressed, the tip of the waveguide 1502 moves at about 0.003
inches of displacement, providing a more robust cutting tool that
can move through tissue at a quicker rate or cut though tougher,
denser matter quicker than the lower-power setting. For example,
cutting through mesentery is generally performed at a more rapid
rate at higher power, whereas vessel sealing can be performed at
lower power and over a longer period of time.
[0320] The present invention, however, is in no way limited to
stacked switches and can also include switches that are independent
of one another. For instance, the shape of the button 4608 may have
a first portion that makes contact with a first low-power switch
and a second portion that, upon further movement of the button,
makes contact with a second high-power switch. The present
invention is to be considered as including any multiple-stage
switch that engages different stages by movement of a single
button.
[0321] In one exemplary embodiment of the present invention, the
switch 4702, 4800 provides a physical resistance analogous to a
compound bow. Compound bows, which are well known for shooting
arrows at a high rate of speed, have a draw-force curve which rises
to a peak force and then lets off to a lower holding force. By
recreating this physical affect with the second sub-switch 4904,
the user of the device will find moving into and engaging the first
sub-switch 4902 to be rather easy, while moving into the
higher-power mode, initiated by depression of the second sub-switch
4904 requiring a higher depression force, to be an occurrence that
takes place only by the operator consciously applying an increased
force. Once the higher depression force is overcome, however, the
force required to maintain the second sub-switch 4904 in the
depressed position decreases, allowing the operator to remain in
the higher-power mode, i.e., keeping the button depressed, without
fatiguing the operator's finger. This compound-bow-type effect can
be accomplished in a variety of ways. Examples include an offset
cam, overcoming a pin force or other blocking object, software
control, dome switches, and many others.
[0322] In one exemplary embodiment of the present invention, the
switch 4702 produces an audible sound when the switch 4702 moves
from the first mode to the second higher-power mode. For example,
the audible sound can be emanated from button, itself, or from the
buzzer 802. The sound notifies the operator of entry into the
higher-power mode. The notification can advantageously prevent
unintended operation of the inventive ultrasonic device.
[0323] c. Near-Over-Center Trigger
[0324] Referring now to FIGS. 61-64, a variable-pressure trigger
will be shown and described. The components of the variable
pressure trigger can be seen in the perspective partial view of the
right hand side of the handle assembly 302 illustrated in each of
FIGS. 61-64. In this view, several of the internal components are
exposed and viewable because much of the shell of the handle
assembly 302 is not present. In practice, many of the components
shown in FIGS. 61-64 are covered by the shell, protected, and not
viewable.
[0325] Looking first to FIG. 61, at least a portion of a trigger
pivot assembly 6102 is shown. The assembly 6102 includes a first
pivoting member 6104 and a second pivoting member 6106. In the
following discussion, a comparison between FIG. 61 and each of
FIGS. 62-64 will be described that illustrates the interaction
between the first pivoting member 6104 and the second pivoting
member 6106 as the trigger 4606 is progressively squeezed by an
operator.
[0326] The first pivoting member 6104 is an elongated structure and
has a first end 6112 and a second end 6114. The first end 6112 of
the first pivoting member 6104 is rotationally coupled to a first
pivot pin 6116 while the second end 6114 is rotationally coupled to
a second pivot pin 6118. In the elevational view of FIG. 61, the
exemplary embodiment of the first pivoting member 6104 can be seen
as including two separate halves, each half coupled to the first
pivot pin 6116 and the second pivot pin 6118 and being connected
together at a center section. There is, however, no requirement
that this pivoting member comprise this configuration. The pivoting
member can be any structure that couples the two pivot pins 6116
and 6118 and provides the proximally directed force at the first
pivot pin 6116 to translate the actuator for the end effector 118,
which end effector 118 will be described in further detail below.
As can be seen in FIGS. 61 to 64, the first pivot pin 6116 rides
within a longitudinally extending guide track 6130 shown on left
body half 4603 of the handle assembly 302, a mirror image of which
is similarly present on the opposing right body half 4503. As the
trigger 4606 is depressed, shown in the progression of FIG. 61, to
FIG. 62, to FIG. 63, to FIG. 64, the first pivot pin 6116
translates in the proximal direction a sufficient distance to
actuate the end effector 118 from an at-rest position (shown by the
first pivot pin position in FIG. 61) to a fully actuated position
(shown by the first pivot pin position in FIG. 64).
[0327] In accordance with the exemplary embodiment shown, the
second pivot pin 6118 is coupled to and is part of the trigger
4606. In particular, the entire second pivoting member 6106,
including the pivot pin 6118, actually comprises a furthest extent
of the trigger 4606. This furthest extent of the trigger 4606 (the
second pivoting member 6106) is, itself, rotationally coupled to a
third (fixed) pivot pin 6110 within the handle assembly 302. This
third pivot pin 6110 defines the axis about which the trigger 4606
rotates with respect to the handle assembly 302. The third pivot
pin 6110 is shared by a sliding rotational-lockout member 6508,
which works in conjunction with a rotational lockout blade. The
purpose and details of the rotational lockout blade will be
explained in the following section.
[0328] Because the position of the third pivot pin 6110 is fixed
with respect to the handle assembly 302, when the trigger 4606 is
squeezed by the operator, the first pivot pin 6116 moves away from
the third pivot pin 6110. In addition, as the first pivot pin 6116
is moving away from the third pivot pin 6110, the second pivot pin
6118 traverses an arc starting at the position shown in FIG. 61,
where the second pivot pin 6118 is well below an imaginary line
6120 connecting the first pivot pin 6116 to the third pivot pin
6110, to the position shown in FIG. 64, where the second pivot pin
6118 is much closer to that imaginary line 6120 still connecting
the first pivot pin 6116 to the third pivot pin 6110.
[0329] The movement of the trigger 4606 from the position shown in
FIG. 61, through the positions shown in FIGS. 62 through 64 results
in a clamping movement of the end effector 118 in a direction
toward the waveguide 1502. In other words, squeezing the trigger
4606 causes the end effector 118 to move from an open position to a
closed position (via movement of the outer tube 7302 as described
below). Advantageously, interaction between the first pivoting
member 6104 and the second pivoting member 6106, illustrated in a
comparison of FIGS. 61 through 64, provides a trigger motion with
varying requisite pressures to maintain trigger depression. This
variable pressure linkage (6110, 6106, 6118, 6104, 6116)
advantageously reduces fatigue on the operator's hand because, once
fully depressed, it requires much less pressure to keep the trigger
4606 in the depressed position as compared to the pressure required
to partially depress the trigger 4606 as shown, for example, in
FIG. 62.
[0330] More specifically, when an operator first applies pressure
to the trigger 4606, a first force is required to move the second
pivot pin 6118 (with reference to the orientation shown in FIG. 61)
upwards. The force required to actuate the end effector 118 is
actually longitudinal because the first pivot pin 6116 must move
proximally. This force moves the second pivot pin 6118 along an arc
that, consequently, moves the first pivot pin 6116 away from the
third pivot pin 6110 and defines two force vectors along the
pivoting members 6104, 6106. The two force vectors, in the position
shown in FIG. 61, are at an angle 6122 of approximately 100.degree.
and are indicated with a left-pointing black vector and a
right-pointing white vector for clarity.
[0331] Turning now to FIG. 62, it can be seen that the trigger 4606
has been moved from the resting position shown in FIG. 61. This
partial movement occurs when the trigger is squeezed during a
typical medical procedure at first tissue contact. As the trigger
4606 is squeezed, i.e., moved toward the handle assembly 302, the
first pivot pin 6116, the first pivoting member 6104, the second
pivoting member 6106, and the second pivot pin 6118 all change
positions. More specifically, the second pivoting member 6106
rotates about the third pivot pin 6110, which is fixed in its
position. Because the third pivot pin 6110 is fixed, the second
pivot pin 6118 begins to swing upward, i.e., toward the imaginary
line 6120. As the second pivot pin 6118 swings upward, a force is
applied to the first pivot member 6104, which translates along the
first pivot member 6104 and is applied to the first pivot pin 6116.
In response, the first pivot pin 6116 slides proximally in a
direction away from the waveguide assembly 304. In this first stage
of translation, shown in FIG. 62, the angle of the force vectors
6122 can be seen as having increased from that shown in FIG.
61.
[0332] In FIG. 63, the trigger 4606 is closed even further. As a
result, further movement of the first pivoting member 6104, the
second pivoting member 6106, the first pivot pin 6116, and the
second pivot pin 6118 occurs. As this movement takes place, the
second pivot pin 6118 moves even closer to the imaginary line 6120,
i.e., closer to being collinear with the first 6116 and third 6110
pivot pins. As indicated by the force vectors 6122, the forces
applied to the pivoting member's 6104, 6106 begin to significantly
oppose each other. The exemplary angle between the vectors 6122 is,
in this position, approximately 150.degree..
[0333] Finally, in FIG. 64 the trigger 4606 has been squeezed until
it makes contact with the battery assembly holding portion of the
handle assembly 302. This is the point of maximum translation of
the first pivoting member 6104, second pivoting member 6106, and
the first pivoting pin 6116. Here, the force vectors substantially
opposite one another, thereby reducing the amount of force felt at
the trigger 4606. That is, as is known in the field of mechanics,
maximum force is required when two vector forces are additive,
i.e., point in the same direction, and minimum force is required
when two vector forces are subtractive, i.e., point in opposite
directions. Because, in the orientation shown in FIG. 64, the
vectors become more subtractive than additive, it becomes very easy
for the user to keep the trigger 4606 depressed as compared to the
position shown in FIG. 61. The ultimate closed position shown in
FIG. 64 is referred to herein as a "near-over-centered" position or
as "near over centering." When the trigger 4606 is in the
near-over-centered position, the force required to keep the trigger
depressed is approximately 45% or less than the force required to
initially squeeze the trigger away from the position shown in FIG.
61.
[0334] d. Rotational Lock-Out
[0335] The present invention provides yet another inventive feature
that prevents rotation of the waveguide assembly 304 whenever
ultrasonic motion is applied to the waveguide 1502. This rotational
lockout feature provides enhanced safety by preventing the cutting
blade from unintentional rotational movement during a surgical
procedure. In addition, prevention of rotation ensures a solid
electrical connection is maintained throughout operation of the
device 300. More specifically, the pair of contacts 5402, 5404 do
not have to slide along the contact rings 5406, 5408 because a
fixed electrical connection at one location along the contact rings
5406, 5408 is maintained during operation. The rotational lockout,
according to one exemplary embodiment of the present invention, is
accomplished through use of a rotational lockout member 6508 shown
in FIGS. 65 and 66.
[0336] Referring first to FIG. 65, a perspective close-up view of
the right hand side of handle assembly 302 is shown with the
right-side cover removed. In this view, a rotational lockout member
6508 can be seen positioned adjacent a rotation-prevention wheel
6502 (which is rotationally fixed to the waveguide rotation spindle
3704 and, thereby, to the waveguide assembly 304). The waveguide
assembly 304 is, therefore, able to rotate along its longitudinal
axis only if the rotation-prevention wheel 6502 is unencumbered and
also able to rotate upon that longitudinal axis.
[0337] To prevent revolution of the rotation-prevention wheel 6502,
the rotational lockout member 6508 includes a wheel-engagement
blade 6504 that extends therefrom in a direction toward the
rotation-prevention wheel 6502. In the position shown in FIG. 65,
the rotational lockout member 6508 does not interfere with the
rotation prevention wheel 6502 because the wheel-engagement blade
6504 is at a distance from the outer circumference thereof. In such
an orientation of the blade 6504, the rotation-prevention wheel
6502, as well as the waveguide assembly 304, can freely spin upon
the longitudinal axis of the waveguide assembly 304.
[0338] Referring now to FIG. 66, the rotational lockout member 6508
has been displaced into a rotation blocking position. In this
position, the wheel-engagement blade 6504 enters the space between
two adjacent castellations 6602 on the outer circumference of the
rotation-prevention wheel 6502 and engages the side surfaces of the
castellations 6602 if the rotation-prevention wheel 6502 rotates.
The rotational lockout member 6508 is fixed in its position within
the handle assembly 302 and, because of this connection, the
engagement between the wheel-engagement blade 6504 and the
rotation-prevention wheel 6502 entirely prevent the
rotation-prevention wheel 6502 from rotate about the longitudinal
axis of the waveguide assembly 304. For example, with 72
castellations 6602 on the outer circumference, the
rotation-prevention wheel 6502 has substantially no rotational play
when rotationally locked. FIGS. 67 through 69 show that the
wheel-engagement blade 6504 engages the rotation-prevention wheel
6502 only when the button 4608 is depressed, thereby preventing
substantially all rotational movement of the waveguide assembly 304
when ultrasonic movement of the waveguide 1502 occurs.
[0339] FIG. 67 shows a perspective underside view of the rotational
lockout member 6508 within the handle assembly 302. Once again, the
right-hand cover of the handle assembly 302 is removed, thereby
exposing several of the internal mechanical components of the
handle assembly 302. These components include the button 4608,
shown here in a transparent view, a U-shaped member 6702 that
slidably engages with the rotational lockout member 6508, and a
spring 6704 that biases the U-shaped member 6702 away from a bottom
portion of the rotational lockout member 6508. FIG. 67 shows the
rotational lockout member 6508, the U-shaped member 6702, and the
spring 6704. In the position shown in FIG. 67, the spring 6704 is
preloaded by pressure that is asserted by the U-shaped member 6702.
The rotational lockout member 6508 is rotationally coupled to and
pivots about a pivot pin 6706, which is fixedly coupled to the
handle assembly 302.
[0340] In addition, FIG. 67 shows a torsional spring 6708 that
biases the rotational lockout member 6508 away from the
castellations 6602 of the rotation-prevention wheel 6502. The
torsional spring 6708 ensures that the natural resting position of
the rotational lockout member 6508 is disengaged from the
rotation-prevention wheel 6502. A spring force of the torsional
spring 6708 is selected so that it is less than a spring force of
the spring 6704. Therefore, movement of the rotational lockout
member 6508 can occur prior to the spring 6704 being fully
compressed.
[0341] In operation of the rotation prevention system, when the
button 4608 is depressed after a short distance, a rear side of the
button 4608 physically contacts the U-shaped member 6702 and moves
the U-shaped member 6702 as further proximal button movement
occurs. In other words, when depressed, the button 4608 imparts a
proximal force on the U-shaped member 6702 in a direction against
the biasing force of the spring 6704. This proximal force causes
the spring 6704 to compress and allows the U-shaped member 6702 to
move in a direction toward the rotational lockout member 6508. This
movement is shown in FIG. 68, where the U-shaped member 6702 is
closer to the rotational lockout member 6508 than the position
shown in FIG. 67. In the view of FIG. 68, the spring 6704 is no
longer visible because the U-shaped member 6702 has moved proximate
to the rotational lockout member 6508 to a point that the lockout
member 6508 completely obscures the spring 6704 in this view.
[0342] When the button 4608 is further depressed, as shown in FIG.
69, the rotational lockout member 6508 pivots around the pivot pin
6706 and swings upwardly toward the rotation-prevention wheel 6502.
As this upward swing occurs, the wheel-engagement blade 6504
engages the castellations 6602 of the rotation-prevention wheel
6502. In other words, the position of the rotational lockout member
6508 shown in FIG. 69 corresponds to the position of the rotational
lockout member 6508 shown in FIG. 66. Similarly, the position of
the rotational lockout member 6508 shown in FIG. 67 corresponds to
the position of the rotational lockout member 6508 shown in FIG.
65.
[0343] In some circumstances, when the button 4608 is depressed,
the wheel-engagement blade 6504 lands on one of the castellations
6602 and does not fall between two of the castellations 6602. To
account for this occurrence, a stroke distance, i.e., the distance
the U-shaped member 6702 is able to move towards the rotational
lockout member 6508 allows an electrical activation of the device
without requiring actual physical movement of the rotational
lockout member 6508. That is, the rotational lockout member 6508
may move slightly, but does not need to fit between two of the
castellations 6602 for ultrasonic operation to occur. Of course,
rotation is still prevented, as any rotational movement will cause
the rotational lockout member 6508 to move up and into the
castellations 6602.
[0344] In a further exemplary embodiment of the present invention,
a rotational lockout member 7002, as shown in FIGS. 70 and 71, can
be provided with one or more blades 7004, 7006 that engage with an
outer surface 7008 of a rotation-prevention wheel 7001. In this
particular embodiment, the rotation-prevention wheel 7001 does not
have teeth on its outer circumference, as the embodiment of the
rotation-prevention wheel 6502 of FIGS. 65 to 69. In the embodiment
of FIGS. 70 and 71, the outer surface 7008 of the
rotation-prevention wheel 7001 is sufficiently malleable to allow
the blades 7004, 7006 to engage the outer surface 7008, for
example, to actually cut into the outer circumference of the
rotation prevention wheel 7001. However, in certain embodiments,
where a razor-type blades 7004, 7006 are utilized, the
rotation-prevention wheel 7001 is sufficiently hard to prevent the
blades 7004, 7006 from penetrating more than a predefined depth
when an expected amount of force is applied.
[0345] Once the blades 7004, 7006 are driven into the outer surface
7008 of the rotation-prevention wheel 7001, as is shown in FIG. 71,
the rotation-prevention wheel 7001 is rendered unable to rotate
about the longitudinal axis of the waveguide assembly 304. Of
course, a single blade or three or more blades can be used to
prevent the rotation-prevention wheel 7001 from rotating. By
separating and angling the blades 7004 and 7006 from one another,
rotation prevention is enhanced in either rotational direction. In
other words, when the blades 7004 and 7006 are angled away from one
another, rotation of the rotation-prevention wheel 7001, in either
direction, causes one of the blades 7004 or 7006 to dig deeper into
the rotation-prevention wheel 7001. In addition, in this particular
embodiment of the rotational-lockout member 7002, a portion of the
rotation-lockout member 7002 may capture the third pivot pin
6110.
[0346] XIII. Tag--Mechanical
[0347] Referring to FIG. 50, the reusable TAG assembly 303 is shown
separate from the handle assembly 302. The inventive TAG assembly
303 includes a transducer shaft 5002 with an ultrasonic waveguide
couple 5004 that is configured to attach a waveguide securely
thereto and, upon activation of the transducer shaft 5002, to
excite the attached waveguide, i.e., impart ultrasonic waves along
the length of the waveguide.
[0348] In this exemplary embodiment, the waveguide couple 5004 is
female and includes interior threads, which are used to secure the
TAG assembly 303 to the waveguide 1502 (see, e.g., FIG. 45) by
screwing an end of the waveguide 1502 onto the threads of the
waveguide couple 5004 with a predefined amount of torque. The
torque should be sufficient so that a mechanical connection created
by the torque is not broken during normal operation of the device.
At the same time, the torque applied to couple the threads should
not exceed a force that will cause the threads to become stripped
or otherwise damaged. During initial coupling of the transducer 902
and waveguide 1502, all that is needed is that one of the
transducer 902 and waveguide 1502 remains relatively stationary
with respect to the other. The waveguide rotation spindle 3704 is
rotationally fixedly coupled to the transducer 902, which,
together, are rotationally freely connected to the body 5005 of the
TAG assembly 303. As such, the waveguide rotation spindle 3704 and
the transducer 902 are both able to freely rotate with respect to
the body 5005. To make the waveguide-transducer connection,
therefore, the waveguide 1502 can be held stationary as the
waveguide rotation spindle 3704 is rotated to couple the interior
threads of the transducer shaft 5002 with the corresponding male
threads at the proximal end of the waveguide 1502. Preferably, the
waveguide 1502 is coupled, i.e., screwed onto the threads of the
waveguide couple 5004 to a point where the mechanical connection is
sufficient to transfer the mechanical ultrasonic movement from the
TAG assembly 303 to the waveguide 1502.
[0349] In one exemplary embodiment of the present invention, a
torque wrench (see FIG. 88) couples to the waveguide rotation
spindle 3704 and allows the user to rotate the spindle 3704 to a
predetermined amount of torque. Once the rotational coupling
pressure between the waveguide couple 5004 and the waveguide 1502
exceeds a predetermined amount of torque, the outer portion of the
torque wrench slips about an inner portion and, thereby, the
spindle 3704 and no further rotation of the spindle 3704 takes
place. Through use of the torque wrench, an operator is able to
apply precisely the proper amount of tension to the junction
between the TAG assembly 303 in the waveguide 1502 and is also
prevented from damaging the threads on either the waveguide couple
5004 or on the waveguide 1502. This embodiment of the torque wrench
also clips onto the spindle 3704 to prevent any possibility of the
wrench slipping off of the TAG assembly 303 without outside force
acting upon it.
[0350] The TAG assembly 303 also has a housing 5006 that protects
and seals the internal working components (shown in FIG. 53) from
the environment, as shown by FIGS. 50 and 53. Because the TAG
assembly 303 will be in the sterile field of the operating
environment, it is sterilizable, advantageously, by vapor phase
hydrogen peroxide, for example. As such, the seal between the
housing 5006 and the body 5005 is aseptic and/or hermetic.
[0351] According to one exemplary, non-illustrated embodiment of
the present invention, the transducer 902 is located entirely
inside the housing 5006--where it cannot be readily secured by the
operator, for example, by holding it steady by hand when the
waveguide assembly 304 is being secured. In such an embodiment, the
TAG assembly 303 is provided with a transducer rotation lock. For
example, the transducer rotation lock can be a button that slides
into a recess in the housing 5006 or, alternatively, by fixing the
rotation of the transducer 902 at a maximum rotational angle so
that, once the maximum rotation is reached, for example, 360
degrees of rotation, no additional rotation is possible and the
waveguide assembly 304 can be screwed thereon. Of course, a maximum
rotation in the opposite direction will allow the waveguide
assembly 304 to be removed as well.
[0352] The housing 5006 has a securing connection 5012 shaped to
selectively removably secure to a corresponding connector part of
the handle assembly 302. See, e.g., FIG. 56. The connection 5012
can be any coupling connection that allows the TAG assembly 303 to
be removably attached and secured to the handle assembly 302, such
as the exemplary "dove-tail" design shown in FIGS. 50 to 53 and 56.
The area of contact between the handle assembly 302 and the TAG
assembly 303 can be sealed so that, in the event of surgical fluids
contacting the TAG assembly 303, they will not introduce themselves
into the interior of the TAG attachment dock 4502.
[0353] It is advantageous for the TAG assembly 303 to be
selectively removable from the handle assembly 302. As a separate
component, the TAG assembly 303 can be medically disinfected or
sterilized (e.g., STERRAD.RTM., V-PRO.RTM., autoclave) and reused
for multiple surgeries, while the less-expensive handle assembly
302 itself may be disposable. In addition, the TAG assembly 303 can
be used in multiple handles or in the same handle up to a desired
maximum number of times before it is required to be disposed.
[0354] FIGS. 51 and 52 provide two additional perspective views of
the TAG assembly 303. FIG. 52 shows a display window for a user
display system (for example, the RGB LED(s) 906) on external
surface of the housing 5006 of the TAG assembly 303. As explained
above, the RGB LED 906 provides various signaling to the user
indicating conditions and modes of the surgical assembly 300.
[0355] FIG. 53 provides a top view of the TAG assembly 303 with the
housing 5006 removed, thereby exposing the generator circuitry of
the TAG assembly 303, see, e.g., FIG. 9. In a further exemplary
embodiment, the generator circuitry includes a memory electrically
connected at least to the processor of the TAG assembly 303 or to
the processor in the battery assembly 301. The memory can be used,
for instance, to store a record of each time the TAG assembly 303
is used. Other data relevant to the TAG assembly 303 and/or the
waveguide assembly 304 and/or the housing assembly 302 and/or the
battery assembly 301 can be stored as well for later access and
analysis. This record can be useful for assessing the end of any
part of the device's useful or permitted life, in particular, the
TAG assembly 303 itself. For instance, once the TAG assembly is
used twenty (20) times, the TAG assembly 303 or the battery
assembly 301 can be programmed to not allow a particular handle or
battery to function with that "old" TAG assembly (e.g., because the
TAG assembly 303 is, then, a "no longer reliable" surgical
instrument). The memory can also store a number of uses any of the
device's peripherals. For an illustrative example only, after a
certain number of uses, it is possibly that one of the parts of the
device can be considered worn as tolerances between parts could be
considered as exceeded. This wear could lead to an unacceptable
failure during a procedure. In some exemplary embodiments, the
memory stores a record of the parts that have been combined with
the device and how many uses each part has experienced.
[0356] In some exemplary embodiments, a memory exists at the
battery assembly 301 and the handle assembly 302 is provided with a
device identifier that is communicatively coupled at least to the
battery assembly 301 and is operable to communicate to the smart
battery 301 at least one piece of information about the ultrasonic
surgical assembly 300, such as the use history discussed in the
preceding paragraph, a surgical handle identifier, a history of
previous use, and/or a waveguide identifier. In this way, a single
smart battery assembly 301 can record use information on a number
of different handle and TAG assemblies 302, 303. When the battery
assembly 301 is placed into a charging unit, such a memory can be
accessed and the data about each part of the system 301, 302/304,
303 can be downloaded into the charger and, if desired, transmitted
to a central facility that is communicatively coupled (e.g.,
through the Web) to the charging station.
[0357] FIG. 54 shows one example of how the generator 904 and the
transducer 902 are electrically coupled so that a physical rotation
of the transducer 902 with respect to the generator 904 is
possible. In this example, the generator 904 has a pair of contacts
5402, 5404 protruding from its underside, adjacent the transducer
902. Proximity of the transducer 902 to the generator 904 places
one of the pair of contacts 5402, 5404 in physical communication
with a corresponding pair of contact rings 5406, 5408 on the
transducer's body 5410 so that a driving signal can be steadily and
reliably applied to the transducer 902 when needed. Advantageously,
the pair of contacts 5402, 5404 maintains electrical contact
regardless of the angle of rotation of the transducer 902.
Therefore, in this embodiment, the transducer 902 can rotate
without any limitation as to the maximum angle or number of
rotations. Additionally, the rings 5406, 5408 and contacts 5402,
5404 ensure that the transducer 902 remains in electrical contact
with the generator circuitry regardless of the point of rotation at
which the torque wrench stops the tightening the transducer 902 to
the waveguide 1502.
[0358] As shown in FIG. 37, the surgical handle assembly 302 has a
spindle 3704 attached to the waveguide assembly 304. The spindle
3704 has indentions that allow a surgeon to easily rotate the
spindle 3704 with one or more fingers and, therefore, to
correspondingly rotate the attached waveguide assembly 304 and the
transducer 902 connected to the waveguide 1502. Such a
configuration is useful for obtaining a desired cutting-blade angle
during surgery.
[0359] FIG. 55 shows one exemplary embodiment of the TAG assembly
303 where the body 5005 and the transducer's shell have been
removed. When a voltage is applied to the piezoelectric crystal
stack 1504, the shaft 5002 moves longitudinally within and relative
to the housing 5006. In this embodiment, the waveguide coupler 5004
is female and includes internal threads (not visible in this view),
which are used to secure the transducer assembly 303 to the
non-illustrated waveguide 1502 by screwing the waveguide 1502 into
the threads with an appropriate amount of torque.
[0360] A novel feature of the TAG assembly 303 is its ability to
mechanically and electrically connect at the same time. FIG. 56
shows an exemplary embodiment of the TAG assembly 303 in the
process of docking with the handle assembly 302. At the same time
the transducer 902 is being coupled to a waveguide 1502 (attached
to the handle assembly 302), the TAG assembly's electrical
connector 5010 is brought into contact with the handle assembly's
electrical connector 5602. The coupling of the TAG's electrical
connector 5010 with the handle's electrical connector 5602 places
the piezoelectric crystal stack 1504 in electrical communication
(direct or indirect) with the battery assembly 301 docked with the
handle assembly 302, as shown in FIG. 37 for example. This
substantially simultaneous coupling can be configured to occur in
all embodiments of the present invention.
[0361] In accordance with further exemplary embodiments of the
present invention, the TAG assembly 303 provides a mechanical
connection prior to establishing an electrical connection. That is,
when attaching the TAG assembly 303 to the handle 302, a mechanical
connection is established between the waveguide 1502 and the
ultrasonic waveguide couple 5004 prior to an electrical connection
being made between the TAG assembly's electrical connector 5010 and
the handle assembly's TAG electrical connector 5602.
Advantageously, because an electrical connection is not made until
after the mechanical connection is established, electrical
"bouncing" is avoided in this embodiment. More specifically, as the
threads 8604 of the waveguide 1502 couple to the ultrasonic
waveguide couple 5004, the electrical connection being made after a
solid mechanical connection insures that the TAG assembly's
electrical connector 5010 and the handle assembly's TAG electrical
connector 5602 are in a fixed positional relationship, at least
momentarily, and instantaneous removal and reestablishment of the
electrical connection will not take place. Similarly, when the
assembly 300 is being disassembled, the electrical connection is
broken prior to a full separation of the mechanical connection.
[0362] In accordance with other exemplary embodiments of the
present invention, the ultrasonic surgical device 300 is able to
accept and drive a plurality of waveguide types, i.e., having
varying dimensions. Where the handheld ultrasonic surgical cautery
assembly 300 is able to accept and drive waveguides 1502 of varying
types/dimensions, the handheld ultrasonic surgical cautery assembly
300 is provided with a waveguide detector coupled to the generator
904 and operable to detect the type (i.e., the dimensions or
characteristics) of the waveguide 1502 attached to the transducer
902 and to cause the generator 904 to vary the driving-wave
frequency and/or the driving-wave power based upon the detected
waveguide type. The waveguide detector can be any device, set of
components, software, electrical connections, or other that is/are
able to identify at least one property of a waveguide 1502
connected to the handheld ultrasonic surgical cautery assembly
300.
[0363] XIV. Waveguide Assembly
[0364] FIGS. 73 to 87 provide detailed illustrations of exemplary
embodiments of the waveguide assembly 304. The waveguide assembly
304 receives ultrasonic movement directly from the transducer 902
when the waveguide 1502 is physically coupled to the TAG assembly
303. The blade portion 7304 of the waveguide 1502 transfers this
ultrasonic energy to tissue being treated. The
ultrasonically-moving blade portion 7304 facilitates efficient
cutting of organic tissue and accelerates blood vessel clotting in
the area of the cut, i.e., accelerated coagulation through
cauterization.
[0365] Referring to FIG. 73, a perspective partial view of the
distal end 7306 of the waveguide assembly 304 is shown. The
waveguide assembly 304 includes an outer tube 7302 surrounding a
portion of the waveguide 1502. A blade portion 7304 of the
waveguide 1502 protrudes from the distal end 7306 of the outer tube
7302. It is this blade portion 7304 that contacts the tissue during
a medical procedure and transfers its ultrasonic energy to the
tissue. The waveguide assembly 304 also includes a jaw member 7308
that is coupled to both the outer tube 7302 and an inner tube (not
visible in this view). As will be explained below, the outer tube
7302 and the non-illustrated inner tube slide longitudinally with
respect to each other. As the relative movement between the outer
tube 7302 and the non-illustrated inner tube occurs, the jaw 7308
pivots upon a pivot point 7310, thereby causing the jaw 7308 to
open and close. When closed, the jaw 7308 imparts a pinching force
on tissue located between the jaw 7308 and the blade portion 7304,
insuring positive and efficient blade-to-tissue contact.
[0366] FIG. 74 provides a perspective underside view of the distal
end 7306 of the waveguide assembly 304 shown in FIG. 73 with the
outer tube 7302 removed. In this view, a distal end 7306 of the
inner tube 7402 can be seen coupled to the jaw 7308. This coupling
is provided by, in the exemplary embodiment illustrated in FIG. 74,
a union of a pair of bosses 7408 on the jaw 7308 with boss-engaging
openings 7414 in each of the pair of arms 7418, 7420 that capture
the bosses 7408 when the jaw 7308 is inserted therebetween. This
relationship is better shown in the cross-sectional perspective
underside view of FIG. 75. From this view, it can be seen that the
boss-engaging openings 7414 of the arms 7418, 7420 of the inner
tube 7402 are coined 7502. The coined arms 7418, 7420 provide a
solid connection between the inner tube 7402 and the jaw 7308. By
coining the openings 7414, the inner tube 7402 is able to engage
the bosses 7408 on the jaw 7308 without having to rely on the outer
tube 7302 for structural pressure/support.
[0367] FIG. 75 also shows that the waveguide 1502 is separate from,
i.e., not attached to, the jaw 7308 or inner tube 7402. In other
words, the waveguide 1502, when energized with ultrasonic energy,
will move relative to the inner tube 7402 and jaw 7308 but will not
contact the inner tube 7402 and will only contact the jaw 7308 if
the latter is pivoted against the blade portion 7304 without the
presence of tissue therebetween. Features of the present invention
that facilitate this independent movement of the waveguide 1502
will be described below.
[0368] Returning to FIG. 74, the jaw 7308 is provided with a pair
of flanges 7422, 7424 at a proximal end 7426 thereof. The flanges
7422, 7424 extend and surround the waveguide 1502 on opposing sides
thereof. Each one of the flanges 7422, 7424 has, at its end, a
pivot control tab 7411, 7412, respectively, extending below the
waveguide 1502 when the bosses 7408 of the jaw 7308 are secured
within the boss-engaging openings 7414 in the arms 7418, 7420. It
is not a requirement for the pivot control tabs 7411, 7412 to
extend below the waveguide 1502 as shown in FIG. 74; this
configuration exists in the exemplary embodiment shown.
[0369] Returning briefly back to FIG. 73, the elevational end view
of the waveguide assembly 304 shows that the pivot control tabs
7411, 7412 of the flanges 7422, 7424 of the jaw 7308 engage a pair
of openings 7311, 7312 in a distal portion 7306 of the outer tube
7302. These features are better illustrated in the fragmentary,
cross-sectional side view of FIG. 77.
[0370] Because the view of FIG. 77 is a cross-sectional view, only
one 7424 of the two flanges 7422, 7424 is shown and the surface
shown is an inside surface of the flange 7424. Correspondingly,
only one of the pivot control tabs 7412 is shown, as well as a
single one of the pair of openings 7312 in the distal portion 7306
of the outer tube 7302. This view makes clear that the opening 7312
surrounds and captures the pivot control tab 7412. Therefore, if
the outer tube 7302 is moved toward the jaw 7308, the opening 7312
will also move relative to the jaw 7308. Conversely, if the outer
tube 7302 is moved away from the jaw 7308, the opening 7312 will
also move relative to the jaw 7308 in the opposite direction. The
captured pivot control tab 7412 nested within the opening 7312
causes a corresponding rotational movement of the jaw 7308 around
the pivot point 7310.
[0371] FIG. 78 provides an elevational partial side view of the end
effector of the waveguide assembly 304. This view shows the outer
tube 7302 substantially covering the flange 7422 of the jaw 7308,
leaving only the pivot control tab 7411 extending from the opening
7311. It should now be apparent that, when the outer tube 7302 is
slid in a proximal direction 7702, i.e., in a direction away from
the jaw 7308, the outer tube 7302 will pull the pivot control tabs
7411, 7412 in the proximal direction 7702. This action causes the
jaw 7308 to pivot around the pivot point 7310 clockwise in FIG. 78
to close, i.e., clamp toward the blade portion 7304 of the
waveguide 1502. This closed position of the jaw 7308 is shown in
FIG. 79.
[0372] FIG. 80 provides another view of the distal end of the jaw
7308 in a closed position where the jaw 7308 is placed in contact
with the blade portion 7304 of the waveguide 1502. Again, this
relationship between the jaw 7308 and the blade portion 7304 of the
waveguide 1502 is the result of a proximal translation of the outer
tube 7302 with respect to the inner tube 7402. The jaw member 7308,
together with the inner and outer tubes 7302, 7402 and the blade
portion 7304 of the waveguide 1052, can be referred to as an end
effector. The end effector can trap tissue between an interior of
the jaw member 7308 and an opposing surface of the blade portion
7304. Trapping the tissue in this way advantageously places the
tissue in solid physical contact with the waveguide 1502. In this
way, when the waveguide 1502 moves ultrasonically, the movement of
the waveguide is directly transferred to the tissue, causing a cut,
a cauterization, or both.
[0373] To facilitate this translation, and with reference back to
FIG. 74, one or more corsets 7404 are provided on the inner tube
7402. The corset 7404 is an area of the inner tube 7402 having a
smaller diameter D' than the average outer diameter D of the inner
tube 7402. See FIG. 74. In accordance with an exemplary embodiment
of the present invention, the corset 7404 is/are provided at a
node(s) of the ultrasonic waveguide 1502. In other words, the
corsets 7404 are located at points along the waveguide 1502 where
the waveguide 1502 does not exhibit ultrasonic motion. Therefore,
the decreased diameter of the inner tube 7402 and its physical
coupling to an interior surface of the outer tube 7302 does not
adversely affect the waveguide's ability to resonate at an
ultrasonic frequency. As also illustrated in FIGS. 74 and 75, for
example, a seal 7406 resides within the corset 7404. The seal 7406,
according to one exemplary embodiment, is an elastomeric O-ring
type seal. Of course, many other materials may be selected as well.
The seal 7406 has an outer diameter sufficiently larger than the
outer diameter D of the 7402 so that the sealing effect is
maintained but to not prevent the outer tube 7302 and the inner
tube 7402 from translating with respect to one another without
substantial friction when the jaw 7308 is actuated.
[0374] As is also shown in FIGS. 74 and 75, a thickness of the seal
7406 is smaller than a longitudinal length of the corset 7404 in
which the seal 7406 resides. This difference in dimension allows
the seal 7406 to travel along the longitudinal length of saddle
7426 when shaped, as shown, as an annulus having a substantially
circular cross-section. In particular, this traveling feature of
the seal 7406 takes place when the outer tube 7302 is translated
with respect to the inner tube 7402. Even more specifically, the
seal 7406 is dimensioned, i.e., has an annular height, to bridge a
gap between an inner surface of the outer tube 7302 and the saddle
7426 of the inner tube 7402 as shown in FIGS. 75 and 77. By filling
this gap completely, the seal 7406 at the distal end 7306 of the
waveguide assembly 304 prevents intrusion of moisture or other
contaminants within the region between the outer tube 7302 and the
inner tube 7402. As the outer tube 7302 is translated, the tight
fit between the outer tube 7302, the inner tube 7402, and the seal
7406 causes the seal 7406 to roll or slide within the saddle 7426
while, at all times maintaining a water-tight seal between the
outer tube 7302 and the inner tube 7402. This translation T is
illustrated, for example, with the thick arrows in FIG. 77.
[0375] Referring now to FIG. 81, the distal end of the waveguide
assembly 304 at the saddle 7426 is shown in cross-section. This
view shows the outer tube 7302 surrounding the inner tube 7402 and
the seal 7406 disposed therebetween in the saddle 7426 of the
corset 7404. As explained, the deformable seal 7406 is a
water-tight connection between the inner wall 8102 of the outer
tube 7302 and the outer surface of the saddle 7426 to prevent
moisture or other contaminants from passing from a distal side 8108
of the seal 7406 to a proximal side 8110 of the seal 7406.
[0376] FIG. 81 also shows a cross-section a coupling spool 8104.
The coupling spool 8104 encircles a distal portion of the waveguide
1502 and is disposed at substantially the same longitudinal
location as the corset 7404. As stated above, the corset 7404 is
located at or substantially near an ultrasonic-movement node of the
waveguide 1502. Therefore, the coupling spool 8104 is also located
at or substantially near that node of the waveguide 1502 and,
likewise, does not couple with the waveguide 1502 to receive
ultrasonic movement. The coupling spool 8104 provides a support
structure that physically links the waveguide 1502 to an inside
surface 8106 of the corset 7404. In the cross-sectional view of
FIG. 81, the coupling spool 8104 has a barbell-shaped longitudinal
cross-section. This reduced cross-section of elastomeric material
reduces the amount of deflection of the waveguide when clamped. The
thick cross-section of the barbell ends of the seal maintain a
water tight seal when the middle section deflects during
clamping.
[0377] FIG. 82 provides a perspective view of an embodiment of the
coupling spool 8104. In this view, an interior surface 8202 of the
coupling spool 8104 can be seen. This interior surface 8202 is in
direct physical contact with the waveguide 1502 when the waveguide
assembly 304 is assembled, as shown in FIG. 81, for example. The
perspective view of FIG. 82 also reveals an exterior saddle shape
8204 of the coupling spool 8104 that substantially corresponds to
the interior shape of the saddle 7426, which is illustrated in FIG.
81 too.
[0378] To help capture and retain the tissue between the jaw member
7308 and the waveguide 1502, the jaw member 7308 includes an insert
7314 having a plurality of teeth 7316. This insert 7314 provides
the jaw member 7308 with an ability to grip the tissue. An
exemplary embodiment of the insert 7314 is shown in the perspective
views of FIG. 84 (from a distal-most end of the insert 7314) and
FIG. 85 (from a proximal-most end of the insert 7314). In addition
to the plurality of teeth 7316, the insert 7314 includes a
distal-most surface 8402, a central smooth channel 8404 located
between first 7316a and second 7316b longitudinal rows of the
plurality of teeth 7316 on a lower surface 8403, a flat proximal
clamping surface 8405, and an upper flange 8406 for securing the
insert 7314 to the jaw member 7308. The distal-most surface 8402
is, as can be seen in FIG. 73, an exposed blunt front surface of
the distal end of the waveguide assembly 304. FIG. 73 illustrates a
channel 7318 of the jaw member 7308 in which the insert 7314 is
disposed when assembled. The inner surfaces of the channel 7318
substantially correspond to the outer surfaces of the upper flange
8406 so that the insert 7314 may be retained in the jaw member 7308
in a substantially movement-free manner. In the exemplary
embodiment of the channel 7318 illustrated, the distal end of the
channel 7318 is narrower than the intermediate portion so that the
insert 7318 may slide from a proximal end of the jaw member 7308 up
to but not past the distal end of the channel 7318. Also shown in
the exemplary embodiment of FIG. 85 is a retaining tab 8502 that,
when the insert 7314 is placed in the jaw 7308 all the way
distally, can be bent downward (towards the insert 7314) and below
the top plane of the insert 7314. In such a bent configuration, the
distal end of the retaining tab 8502 will oppose, and possibly rest
against, the rear surface 8504 of the insert 7314 and/or flange
8406. With such an opposition, the insert 7314 is prevented from
exiting the jaw 7308.
[0379] The offset between the proximal-most surface 8402 and the
flange 8406, shown in FIG. 84, facilitates the placement of
proximal-most surface 8402 at the distal most portion of the jaw
member 7308. That is, the insert 7314 slides within the jaw member
7308 until it is fully seated within the jaw member 7308. It is,
however, the flange 8406 that is physically secured by the jaw
member 7308. More specifically, as is shown in FIGS. 84 and 85, the
flange 8406 extends beyond the plurality of teeth 7316 on both
sides thereof. However, the flange 8406 does not extend all the way
to the proximal-most surface 8402. When the insert 7314 is slid
inside the jaw member 7308, the extending side portions of the
flange 8402 travel within the channel 7318 formed in the jaw member
7308. Because the flange 8406 does not extend all the way to the
proximal-most surface 8402, when the flange 8406 reaches the end of
the channel 7318, the proximal-most surface 8402 of the insert 7314
will extend beyond the channel 7318 up to the position shown in
FIG. 73.
[0380] Focusing now on the exemplary embodiment of the teeth 7316,
it can be seen in FIGS. 84 and 85 that the teeth 7316 do not extend
completely across the lower surface 8408 of the insert 7314.
Instead, in the embodiment of FIGS. 84 and 85, a first row of teeth
7316a and a second row of teeth 7316b, which oppose the first row
of teeth 7316a, are separated by a central smooth channel 8404. The
central smooth channel 8404 provides a solid smooth surface that
lines up directly over the waveguide 1502. It is this smooth
surface 8404 that comes into contact with the ultrasonically-moving
waveguide 1502 during a procedure and helps seal the tissue by
facilitating continued, non-impeded ultrasonic movement of the
waveguide 1502 with even pressure along its length.
[0381] Moving now to FIG. 86, a fragmentary perspective view of an
interior of the handle portion 302 is illustrated. This view shows
a proximal-most end 8601 of the waveguide 1502, which features a
set of threads 8604 used to couple the waveguide 1502 to the TAG
assembly 303. As described above, the illustrated location of the
proximal-most end 8601 of the waveguide 1502 within the handle
portion 302 is substantially the location where the waveguide
assembly 304 remains when it is coupled to the TAG assembly 303.
When the TAG assembly 303 is inserted into the handle portion 302,
see, for example FIG. 45, the transducer shaft 5002 aligns with and
thereby allows a secure longitudinal coupling of the threads 8604
and the ultrasonic waveguide couple 5004.
[0382] The waveguide 1502 is surrounded by the inner tube 7402 and,
then, the outer tube 7302. This view of the proximal-most end 8606
of the outer tube 7302 shows that the outer tube 7302 terminates at
its proximal-most end 8606 with a flared section 8608. The flared
section 8608 features a pair of channels 8610 and 8612 (8612 not
fully shown in this view) forming a keyway. These channels are
shown as opposing but need not be in this configuration. Residing
within the channels 8610, 8612 is a yoke 8602 that is fixedly
coupled to the waveguide 1502. The coupling of the yoke 8602 and
the waveguide 1502 will be shown in more detail in the following
figure, FIG. 87. Continuing with FIG. 86, it can be seen that the
yoke 8602 is provided with a boss 8616 that extends within the
channel 8610. Although not shown in this view, the yoke 8602 is
also provided with a second boss that extends likewise within the
second channel 8612. Engagement between the bosses 8616 of the yoke
8602 and the channels 8610, 8612 of the flared section 8608
provides a rotational-locking relationship between the waveguide
1502, the inner 7402, and the outer tube 7302. That is, because the
bosses engage the channels 8610, 8612, any rotation of the
waveguide 1502 is shared by both the inner tube 7402 and the outer
tube 7302. The proximal end of the inner tube 7402 does not extend
past the yoke 8602. The rotational connection between the yoke 8602
and the inner tube 7402 occurs through an internal feature of the
waveguide rotation spindle 3704.
[0383] Focusing now on FIG. 87, a perspective view of an interior
of the handle portion 302 is once again illustrated. In this view,
however, the outer tube 7302 has been removed (along with a right
half of the waveguide rotation spindle 3704). The removed outer
tube 7302 exposes a majority of the yoke 8602. Although not
viewable in either FIG. 86 or FIG. 87, the yoke 8602 is, in one
exemplary embodiment of the present invention, symmetrical with a
second boss extending in a direction substantially directly
opposite the first boss 8616. As the perspective view of FIG. 87
shows, the waveguide 1502 features at least one exterior spline
8702, here a set of splines symmetrically disposed about the
waveguide 1502. Each spline 8702 extends away radially from a
central longitudinal axis 8706 of the waveguide 1502. The yoke 8602
is provided with a plurality of interior keyways 8704, each keyway
8704 aligning with one of the extensions of the spline 8702 and
having a shape substantially corresponding to a respective one of
the splines 8702 so that, when connected as shown, the yoke 8602
securely rests at its shown longitudinal position on the waveguide
1502. This longitudinal position on the waveguide 1502, too, is
located at an ultrasonic vibration node where movement is
minimal/non-existent. This aligning and securing engagement between
the keyways 8704 and the splines 8702 places the keyways 8704 and
the splines 8702 in a fixed rotational relationship. In other
words, as the waveguide 1502 rotates, so too must the yoke
8602.
[0384] Referring back now to FIG. 66, it can now be seen that the
channels 8610, 8612 of the flared section 8608 of the outer tube
7302 are the features that engages the rotation-prevention wheel
6502. Due to this engagement, any rotation imparted on the
waveguide rotation spindle 3704 by the user will result in a direct
and corresponding rotation of the rotation-prevention wheel 6502,
the outer tube 7302, the inner tube 7402, the yoke 8602, and the
waveguide 1502. The following is a result of this connection
configuration: when the rotational lockout number 6508 is engaged
with the rotation-prevention wheel 6502, not only is the
rotation-prevention wheel 6502 prevented from rotating, so too is
the entire waveguide assembly 304, 3704, 7302, 7402, 8602, 1502. In
the same sense, when the rotation-prevention wheel 6502 is not
engaged with the rotational lockout number 6508, a user can freely
rotate the spindle 3704, which is physically coupled to the
rotation-prevention wheel 6502, and cause a rotation of the
waveguide assembly 304 along a longitudinal axis 8706.
[0385] XV. Additional Safety Features
[0386] In an exemplary safety embodiment for any of the
configurations of the invention, the system can have a safety
mechanism grounding the surgeon using the device to the handheld
ultrasonic surgical cautery assembly 300. In the event the
waveguide 1502 accidentally makes contact with the surgeon, the
handheld ultrasonic surgical cautery assembly 300 senses this
grounding and immediately ceases movement of the waveguide 1502,
thereby instantly preventing the surgeon from cutting him/herself.
It is possible to provide a safety circuit that can sense contact
with the surgeon and interrupt ultrasonic power delivery because
the hand-held instrument 300 is not connected to earth ground. For
example, a capacitive contact patch located on the handle assembly
302 is connected to a capacitive-touch sensing circuit (such as is
used for capacitive switching and known to those in the art) and
disposed to detect contact of the working tip with the surgeon.
When such contact is detected, the drive circuit 904 of the
instrument will be shut down to avoid applying cutting energy to
the surgeon. Such a sensing circuit would be impractical in systems
of the prior art, where the handpiece is connected to a large piece
of earth-grounded electrical equipment.
[0387] In accordance with another exemplary embodiment of the
present invention, after the battery assembly 301 is physically and
electrically coupled to the handle assembly 302, the handheld
ultrasonic surgical cautery assembly 300 will not operate until the
button 4608 is changed from a depressed state to a released state,
i.e., actively placed into a non-depressed position. This feature
prevents the handheld ultrasonic surgical cautery assembly 300 from
operating immediately upon connection of the battery assembly 301
to the handle assembly 302, which otherwise could occur if the
operator was unintentionally depressing the button 4608 when
connecting the battery assembly 301 to the handle assembly 302.
[0388] As has been described, the present invention provides a
small and efficient hand-held ultrasonic cutting device that is
self-powered and, therefore, cordless, which eliminates entirely
the expensive set-top box required by the prior art devices.
Advantageously, the device of the invention allows a user to
operate completely free of cords or other tethering devices. In
addition to the advantages of reduced cost, reduced size,
elimination of a tethering cord for supplying power and carrying
signals, and providing a constant motional voltage, the instant
invention provides unique advantages for maintaining the sterile
condition in a surgical environment. As has been explained, the
inventive device is comprised entirely of sterilizable components
that are maintained wholly in a sterile field. In addition, all
electronic controls of the inventive system exist within the
sterile field. Therefore, any and all troubleshooting can take
place inside the sterile field. That is, because the inventive
device is not tethered to a desktop box, as required in the prior
art, a user need never exit the sterile field to perform any
function with the inventive handheld ultrasonic surgical cautery
assembly 300 (e.g., troubleshooting, replacing batteries, replacing
waveguide assemblies, etc.). Furthermore, the inventive two-stage
button allows an operator complete control of any surgical task
without requiring the operator to focus their visual attention on
the instrument itself. In other words, the operator does not have
to look to ensure (s)he is preparing to push the proper button, as
only one button is used.
[0389] The invention also provides low-voltage or battery-voltage
switching or wave-forming stages prior to the transformer voltage
step-up stage. By "marrying" all of the frequency sensitive
components within one place (i.e., the handle), the present
invention eliminates any inductive losses that occur between prior
art set-top boxes and hand pieces--a disadvantage suffered by all
prior-art ultrasonic cautery/cutting devices. Because of the close
coupling between the drive circuitry and the matching network 1012,
the overall power modification circuit is tolerant of higher Q
factors and larger frequency ranges.
[0390] Although specific embodiments of the invention have been
disclosed, those having ordinary skill in the art will understand
that changes can be made to the specific embodiments without
departing from the spirit and scope of the invention. The scope of
the invention is not to be restricted, therefore, to the specific
embodiments, and it is intended that the appended claims cover any
and all such applications, modifications, and embodiments within
the scope of the present invention.
* * * * *