U.S. patent application number 16/868009 was filed with the patent office on 2020-08-20 for ultrasonic surgical handpiece assembly.
The applicant listed for this patent is Colin James Drewek. Invention is credited to Colin Drewek, Megan James.
Application Number | 20200261110 16/868009 |
Document ID | 20200261110 / US20200261110 |
Family ID | 1000004807122 |
Filed Date | 2020-08-20 |
Patent Application | download [pdf] |
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United States Patent
Application |
20200261110 |
Kind Code |
A1 |
Drewek; Colin ; et
al. |
August 20, 2020 |
ULTRASONIC SURGICAL HANDPIECE ASSEMBLY
Abstract
The present disclosure relates to an ultrasonic surgical
handpiece assembly comprising a surgical handpiece for use with an
irrigation sleeve and ultrasonic tip. The surgical handpiece may
comprise a piezoelectric transducer disposed within a housing and
configured to manipulate the ultrasonic tip. One or more lumens
and/or a flex circuit including an antenna may be disposed within
the surgical handpiece housing. The lumen(s) may be configured to
provide irrigation and/or aspiration to the irrigation sleeve
and/or ultrasonic tip. The irrigation sleeve may comprise a second
antenna configured to communicate with the ultrasonic handpiece
antenna. The irrigation sleeve may further comprise and an
alignment and/or coupling feature configured to removably secure
the irrigation sleeve to the housing and orient the second antenna
relative to the ultrasonic handpiece antenna. The irrigation sleeve
may further comprise a lumen for supplying irrigation and/or
aspiration to the ultrasonic tip.
Inventors: |
Drewek; Colin; (Marysville,
MI) ; James; Megan; (Portage, MI) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Drewek; Colin
James; Megan |
Marysville
Portage |
MI
MI |
US
US |
|
|
Family ID: |
1000004807122 |
Appl. No.: |
16/868009 |
Filed: |
May 6, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16580639 |
Sep 24, 2019 |
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16868009 |
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62735445 |
Sep 24, 2018 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 90/98 20160201;
A61B 2017/32007 20170801; A61B 17/320068 20130101; A61B 2017/320084
20130101; A61B 2017/00402 20130101; A61B 2017/320069 20170801; A61B
2017/00017 20130101; A61B 2017/00477 20130101 |
International
Class: |
A61B 17/32 20060101
A61B017/32; A61B 90/98 20060101 A61B090/98 |
Claims
1. A method of making a surgical handpiece with a flex circuit
having an antenna, said method comprising: providing an internal
flex circuit having an antenna at a distal end of said internal
flex circuit; providing a first housing component and a second
housing component, wherein the first and second housing components
are injection molded such that one of the first and second housing
components defines a void and one of the first and second housing
components comprises an irrigation conduit configured to
communicate irrigation fluid through the surgical handpiece;
positioning the internal flex circuit within the void of one of the
first housing component and the second housing component; securing
the first housing component to the second housing component to fix
the internal flex circuit into position; and overmolding the first
housing component, the second housing component, and a portion of
the internal flex circuit with an autoclaveable plastic to fix the
location of the antenna of the internal flex circuit in the first
and second housing components
2. The method of claim 1, further comprising the initial step of
injection molding the first housing component and the second
housing component.
3. The method of claim 2, wherein the first housing component and
the second housing component are injection molded to comprise
corresponding channels extending longitudinally along the length of
each of the first housing component and the second housing
component, wherein the corresponding channels define the void when
the first housing component and the second housing component are
secured together.
4. The method of claim 3, wherein the step of positioning the
internal flex circuit within the void comprises inserting a portion
of said internal flex circuit in the channel of the first housing
component or the second housing component prior to securing the
first housing component to the second housing component.
5. A method of making a surgical handpiece with a flex circuit
having an antenna, said method comprising: providing an internal
flex circuit having a sensor; providing a first housing component
and a second housing component, wherein the first and second
housing components are injection molded such that one of the first
and second housing components defines a void and one of the first
and second housing components comprises an irrigation conduit
configured to communicate irrigation fluid through the surgical
handpiece; positioning the internal flex circuit within the void of
one of the first housing component and the second housing
component; securing the first housing component to the second
housing component to fix the internal flex circuit into position;
and overmolding the first housing component, the second housing
component, and a portion of the internal flex circuit with an
autoclaveable plastic to fix the location of the sensor of the
internal flex circuit in the first and second housing
components.
6. An ultrasonic surgical handpiece comprising: a housing defining
a cavity, said housing defining a proximal aperture and a distal
aperture; a transducer comprising a distal end and a proximal end
disposed within said cavity of said housing, said transducer
configured to expand and contract along a longitudinal axis of the
transducer; a tube defining a transducer lumen comprising a distal
portion and a proximal portion, said lumen being configured to
extend from said proximal end to said distal end of said transducer
and be oriented to be generally parallel to said longitudinal axis;
a barrier member having a shell portion wholly within said cavity
and a channel portion that extends proximally from said shell
portion and extends through said proximal aperture, the shell
portion defining a shell lumen configured to encase said transducer
positioned within said housing, the channel portion configured to
rout aspirated fluid from said transducer lumen to a suction line;
a horn at least partially disposed within said housing, said horn
coupled to said distal end of said transducer, said horn defining a
horn lumen that is in fluid communication with said transducer
lumen when said horn is coupled to said transducer; a rear seal
positioned between said proximal end of said transducer and an
interior surface of said cavity, said rear seal configured to abut
said proximal end of said transducer and define a first aperture
that engages an exterior surface of said tube and an interior
surface of said barrier member, said rear seal is positioned
between said shell portion and said channel portion of said barrier
member such that fluid cannot enter said shell portion of said
barrier member; a front seal positioned disposed radially about an
exterior surface of said horn, said front seal; a potting seal
positioned between said transducer and a distal end of said shell
portion of said barrier member, said potting seal configured to
abut said distal end of said transducer and define a second
aperture for receiving said coupling feature of said horn; wherein
said rear seal is configured to prevent moisture ingress into said
cavity proximate the proximal end of said transducer; and wherein
said potting seal is configured to prevent moisture ingress into
said cavity proximate said distal end of said transducer.
7. The ultrasonic handpiece assembly of claim 6, wherein said
housing further comprises: an attachment region formed in said
distal end of said housing, said attachment region defining a
recess comprising a third face and a plurality of side walls
configured to receive said hub of said irrigation sleeve; an
attachment element in said third face of said recess, said
attachment element configured to receive said retention finger of
said irrigation sleeve to removably couple said irrigation sleeve
to said ultrasonic handpiece; wherein said irrigation outlet
fitting is configured to extend from said third face of said recess
to removably couple with said irrigation sleeve to provide
irrigation fluid to said irrigation sleeve; and wherein said second
end of said horn is configured to protrude from said face.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 16/580,639, filed Sep. 24, 2019, which claims the benefit of
Provisional Application 62/735,445, filed on Sep. 24, 2018, each of
which are hereby incorporated herein by reference in their
entirety.
SUMMARY
[0002] The present disclosure relates generally to an ultrasonic
surgical handpiece assembly. The ultrasonic surgical handpiece
assembly may include a handpiece comprising a transducer and a
horn, wherein the transducer is configured to manipulate the horn
to actuate a cutting tip that is coupled to the horn to cut or
remove biological material.
[0003] An exemplary configuration provides a sleeve for use with an
ultrasonic handpiece including a coupling housing comprising a
handpiece transceiver and configured to surround a portion of an
ultrasonic tip including a cutting feature. The sleeve may comprise
a hub comprising a proximal portion, a distal portion, and a first
lumen extending through the hub. The proximal portion may have a
first face configured to abut the ultrasonic handpiece and a second
face positioned distally of the first face. The sleeve may further
comprise a tube body comprising a distal end and a proximal end.
The tube body may extend from the distal portion of the hub and be
configured to define a second lumen in fluid communication with the
first lumen of the hub. The second lumen may be configured to
surround the portion of the ultrasonic tip. The sleeve may also
comprise a tube aperture in an interior surface of the second
lumen. The tube aperture may be positioned at an intermediate point
along the second lumen between the proximal end and distal end of
the tube body and such that the tube aperture is facing inward
towards the second lumen. An irrigation conduit may be adjacent to
the second lumen, the irrigation conduit configured to extend from
the proximal end of the tube body to the tube aperture. An
irrigation aperture and a tip aperture in the first face, the tip
aperture configured to be in communication with the first lumen. An
irrigation fitting may be positioned within the irrigation aperture
of the first face of the hub and in fluid communication with the
irrigation tube. The sleeve may also comprise at least one
retention finger protruding proximally from the first face, the
retention finger configured to engage the coupling housing of the
ultrasonic handpiece. The sleeve may further comprise a cavity
defined in the proximal portion of the hub, the cavity comprising
an opening in a first surface. A sleeve transceiver may be
positioned within the cavity and configured to communicate with the
corresponding handpiece transceiver.
[0004] In another exemplary configuration, an ultrasonic surgical
handpiece may be configured for use with an ultrasonic tip assembly
including a sleeve comprising at least one retention member. The
ultrasonic surgical handpiece may comprise a housing comprising a
proximal end and an opposing distal end, said housing configured to
define a volume. The ultrasonic surgical handpiece may also
comprise a transducer at least partially disposed within the volume
defined by the housing, and a horn comprising a first end and an
opposing second end. The horn may be configured to be at least
partially disposed within the volume defined by the housing, the
first end of said horn operatively coupled to the transducer.
Wherein the transducer is configured to vibrate/oscillate the horn
when operated. The ultrasonic surgical handpiece may also comprise
an attachment region formed in the distal end of the housing. The
attachment region may define a recess comprising a face and a
plurality of side walls configured to receive the sleeve. An
attachment element in the face of the recess, wherein the
attachment element may be configured to receive the at least one
retention member of the sleeve to removably couple the sleeve to
the ultrasonic surgical handpiece. The ultrasonic surgical
handpiece may further comprise a first fitting extending from the
face of the recess and may be configured to removably couple with
the sleeve to provide irrigation to the sleeve, and wherein the
second end of the horn is configured to protrude from the face.
[0005] In yet another exemplary configuration, an ultrasonic
handpiece assembly may be configured for use with an elongated
cutting instrument including an aspiration lumen extending the
length of the elongated cutting instrument. The assembly may
comprise an ultrasonic handpiece comprising: a housing comprising a
proximal end and an opposing distal end, the housing defining a
volume and the distal end having a distal face. The handpiece may
also comprise a transducer configured to define a first conduit,
the transducer at least partially disposed within the volume
defined by the housing. The handpiece may also comprise a horn
comprising a first end and an opposing second end, the horn
configured to be at least partially disposed within the volume
defined by the housing. The horn may comprise a second conduit in
said horn configured to extend between the first end and the second
end of the horn. The horn may also comprise a threaded coupler on
the second end of the horn configured to extend from the distal end
of the housing and removably couple the horn to the elongated
cutting instrument. The assembly may also comprise an irrigation
outlet fitting extending from the distal end of the housing and
configured to discharge irrigation fluid from the housing. The
assembly may also comprise an irrigation sleeve The irrigation
sleeve may comprise a hub defining a first lumen and comprising an
irrigation inlet fitting, the irrigation inlet fitting configured
to engage the irrigation outlet fitting to receive irrigation fluid
discharged from the ultrasonic handpiece. The sleeve may also
comprise a sleeve body extending distally from the hub, the sleeve
body defining a second lumen configured to surround a portion of
the elongated cutting instrument when the elongated cutting
instrument is inserted into the irrigation sleeve. The sleeve may
further comprise a tube aperture in an interior surface of the
second lumen, the tube aperture positioned at an intermediate point
along the second lumen between a proximal end and a distal end of
the sleeve body such that the tube aperture is facing toward the
second lumen to provide irrigation fluid to a surgical site and to
cool the elongated cutting instrument. The sleeve may also comprise
an irrigation conduit running adjacent to the second lumen, the
irrigation conduit configured to extend from the irrigation inlet
fitting of the sleeve body to the tube aperture to create a fluid
passageway for communicating irrigation fluid to the elongated
cutting instrument, wherein the irrigation outlet fitting on the
housing may be configured to engage the irrigation inlet fitting on
the irrigation sleeve when the irrigation sleeve is coupled to the
housing such that the irrigation fluid flows entirely within the
ultrasonic handpiece and the hub. Furthermore, the first end of the
horn may be operatively coupled to the transducer such that the
first conduit of the transducer and the second conduit of the horn
may define a continuous passageway extending from the proximal end
to the distal end of the housing.
[0006] In yet another exemplary configuration, an ultrasonic
handpiece assembly may be configured for use with an elongated
cutting instrument. The assembly may comprise an ultrasonic
handpiece comprising a housing, a transducer, and a horn. The
housing may comprising a proximal end and an opposing distal end,
the housing defining a volume and the distal end having a distal
face. The transducer may be configured to define a first conduit,
the transducer at least partially disposed within the volume
defined by the housing. The horn may comprise a first end and an
opposing second end, the horn configured to be at least partially
disposed within the volume defined by the housing. The horn may
comprise a second conduit in the horn configured to extend between
the first end and the second end of the horn. An irrigation outlet
fitting extending from the distal end of the housing and configured
to discharge irrigation fluid from the housing. A threaded coupler
may be disposed on the second end of the horn configured to engage
the elongated cutting instrument. There may be a recess in the
distal end of the housing, the recess comprising a recessed face
and a plurality of side walls configured to define an asymmetrical
shape. The assembly may further comprise a handpiece transceiver
comprising a handpiece coil comprising a first axis, the handpiece
transceiver positioned within one of the plurality of side walls.
The assembly may also comprise an irrigation sleeve comprising a
hub comprising a proximal portion and a distal portion, the
proximal portion configured to define an asymmetrical protrusion
extending proximally from the distal portion and sized to be
inserted within the recess of the housing. The irrigation sleeve
may also comprise an abutment portion configured to contact the
distal face of the ultrasonic handpiece when the asymmetrical
protrusion is inserted in the recess of the housing. The
asymmetrical protrusion may be configured to ensure proper
alignment of the irrigation sleeve with the housing. The irrigation
sleeve may further comprise a sleeve transceiver comprising a
sleeve coil and a memory unit, the memory unit storing information
pertaining to the optimal driving parameter for the elongated
cutting instrument. The sleeve coil may have a second axis, wherein
the sleeve transceiver is located in a cavity defined in the
asymmetrical protrusion of the hub such that the second axis of the
sleeve coil is oriented in parallel to the first axis of the
handpiece coil.
[0007] In yet another exemplary configuration, a tubing connector
may be configured for integrally connecting an irrigation line, an
aspiration line, and a conductor to a proximal portion of an
ultrasonic surgical handpiece wherein the ultrasonic surgical
handpiece comprises an irrigation fitting and an aspiration fitting
that extend proximally from the proximal portion of the handpiece.
The tubing connector may comprise a base comprising a distal end
and a proximal end. The tubing connector may also comprise a first
lumen in said base configured to create a fluid passageway through
the base that extends from the distal end to the proximal end of
the base. The first lumen may be configured to receive the
aspiration line proximate the proximal end of the base. The base
may define a groove in a perimeter of the base that extends between
the proximal region to the distal region of the base, the groove
configured to receive the conductor. A portion of the first lumen
proximate the distal end of the base is configured to removably
couple with the aspiration fitting of the ultrasonic surgical
handpiece via a friction fit, and wherein the tubing connector is
configured to reduce strain of the irrigation line and the
aspiration line when coupled to the surgical handpiece.
[0008] These and other configurations, features, and advantages of
the present disclosure will be apparent to those skilled in the
art. The present disclosure is not intended to be limited to or by
these configurations, embodiments, features, and/or advantages.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] Referring now to the drawings, exemplary illustrations are
shown in detail. Although the drawings represent schematic
embodiments, the drawings are not necessarily to scale and certain
features may be exaggerated to better illustrate and explain an
innovative aspect of an illustrative embodiment. Further, the
exemplary illustrations described herein are not intended to be
exhaustive or otherwise limiting or restricting to the precise form
and configuration shown in the drawings and disclosed in the
following detailed description.
[0010] Advantages of the present invention will be readily
appreciated as the same becomes better understood by reference to
the following detailed description when considered in connection
with the accompanying drawings wherein:
[0011] FIG. 1 is a side view of an ultrasonic surgical handpiece
assembly, including an ultrasonic handpiece, an irrigation sleeve,
an ultrasonic tip, and a control console.
[0012] FIG. 2 is a top view of the ultrasonic surgical handpiece
assembly of FIG. 1.
[0013] FIG. 3 is a sectional view of the ultrasonic surgical
handpiece assembly of FIG. 1.
[0014] FIG. 4 is a zoomed (enhanced) sectional view of a rear
housing portion of the ultrasonic handpiece of FIG. 3.
[0015] FIG. 5 is a perspective view of a front housing portion of
the ultrasonic handpiece of FIG. 1.
[0016] FIG. 6 is an exploded view of the front housing portion of
FIG. 4.
[0017] FIG. 7 is a front view of the ultrasonic handpiece of FIG.
6.
[0018] FIG. 8 is a partially exploded view of the ultrasonic
surgical handpiece assembly of Figured 1, illustrating an example
configuration of an interface between the front housing portion of
the ultrasonic handpiece and the irrigation sleeve.
[0019] FIG. 9 is a zoomed (enhanced) sectional view of the front
housing portion of the ultrasonic handpiece coupled to the
irrigation sleeve.
[0020] FIG. 10 is a perspective view of the irrigation sleeve and
the ultrasonic tip of the ultrasonic surgical handpiece assembly
FIG. 1, for use with the ultrasonic handpiece.
[0021] FIG. 11A is a bottom view of the irrigation sleeve and the
ultrasonic tip of FIG. 10.
[0022] FIG. 11B is a sectional view of the irrigation sleeve and
the ultrasonic tip of FIG. 10.
[0023] FIG. 12 is a perspective view of an example configuration of
a tubing connector for use with the ultrasonic surgical handpiece
assembly FIG. 1, including the ultrasonic handpiece shown in
phantom.
[0024] FIG. 13 is a first perspective view of the tubing connector
of FIG. 12.
[0025] FIG. 14 is a second perspective view of the tubing connector
of FIG. 12.
[0026] FIG. 15 is a third perspective view of the tubing connector
of FIG. 12.
[0027] FIG. 16 is a cut-away sectional view of the tubing connector
of FIG. 12 coupled to an ultrasonic handpiece with power,
aspiration, and irrigation lines extending therefrom.
DETAILED DESCRIPTION
[0028] As medical professionals strive for reducing the size of the
incisions and the amount of recovery time required following
invasive medical procedures, the size of medical instruments used
in various medical procedures have become smaller. Many of the
medical instruments utilized in performing the various medical
procedures may include the use of a cutting accessory, such as
ultrasonic handpieces, high-speed drills, rotating burs,
open-window shavers, and the like. Many of these cutting
accessories may require the use of irrigation or aspiration (i.e.,
suction) to reduce heat and/or remove debris at the surgical site.
Similarly, irrigation may be utilized to lubricate a cutting
accessory.
[0029] One example of a surgical instrument that may utilize
irrigation and aspiration systems is an ultrasonic handpiece.
Generally, one or more lines may be coupled to the ultrasonic
handpiece to supply irrigation and suction. The ultrasonic
handpiece may further comprise a sleeve comprising one or more
lumens that may be utilized to direct fluid from an irrigation
source toward the surgical site and the cutting accessory, i.e., an
ultrasonic tip. Irrigation and/or aspiration lines have typically
been coupled to the exterior of the ultrasonic handpiece to be
coupled to the sleeve. The sleeve and/or cutting accessory may be
disposable, resulting in the sleeve and/or cutting accessory only
temporarily being attached to the ultrasonic handpiece. The
introduction of additional elements, such as the irrigation and/or
aspiration lines to the exterior of the handpiece can result in
increasing the size, profile, and/or general bulkiness of the
ultrasonic handpiece. This may obstruct the medical professional's
view and/or distract the medical professional during operation of
the medical instrument during the medical procedure. The
positioning of the irrigation and/or aspiration lines relative to
the ultrasonic handpiece may similarly effect the ergonomics of the
ultrasonic handpiece, inhibiting the medical professional's ability
to manipulate the ultrasonic handpiece.
[0030] Therefore, an ultrasonic surgical handpiece assembly 10 may
be configured to comprise an ultrasonic handpiece 12 including
internal irrigation and aspiration lumens to reduce the size of the
handpiece and improve ergonomics, such as the ultrasonic surgical
handpiece assembly 10 illustrated in FIGS. 1-3.
[0031] Referring to FIGS. 1 and 2, an example configuration of an
ultrasonic surgical handpiece assembly 10 is illustrated. The
ultrasonic surgical handpiece assembly 10 may comprise an
ultrasonic handpiece 12 comprising a proximal end and distal end.
The ultrasonic surgical handpiece assembly 10 may further comprise
sleeve 18 and an ultrasonic tip 20 that may be coupled to the
distal end of the ultrasonic handpiece 12. The sleeve 18 may be
configured to provide irrigation to the ultrasonic tip 20 and/or
the surgical site. It is further contemplated that the sleeve 18
may also be configured to provide aspiration to the ultrasonic tip
20. The ultrasonic tip 20 may comprise a cutting feature 34 that is
configured to cut, shape, and/or remove biological tissue.
[0032] The ultrasonic tip 20 may have various features, as
described in U.S. Pat. Nos. 6,497,715; 6,955,680; and 6,984,220;
which are hereby incorporated herein by reference in their
entirety.
[0033] The ultrasonic surgical handpiece assembly 10 may also
comprise a cable 30 or other power cord comprising a power
connector 28 or adapter configured to couple the ultrasonic
surgical handpiece assembly 10 to a power supply, such as a control
console 13 configured to regulate the various aspects of the
ultrasonic handpiece 12. For example, the console 13 may be
configured to regulate the power and the signal supplied to the
ultrasonic handpiece 12. The console 13 may also be configured to
regulate the irrigation and/or aspiration functions of the
ultrasonic handpiece 12 to optimize performance of the ultrasonic
surgical handpiece assembly 10.
[0034] Referring to FIG. 3, a sectional view of the ultrasonic
surgical handpiece assembly 10 of FIG. 1 is provided. The
ultrasonic handpiece 12 may comprise a proximal housing portion 14
and a distal housing portion 16, each of which may be configured to
define a void. The proximal housing portion 14 and the distal
housing portion 16 may be configured as two separate components and
may be coupled together by a laser weld or similar coupling
process. Alternatively, proximal housing portion 14 and the distal
housing portion 16 may including corresponding coupling features
configured to couple the proximal housing portion 14 and the distal
housing portion 16 together. It is also contemplated that the
proximal housing portion 14 and the distal housing portion 16 may
be configured as a single unitary component.
[0035] A transducer 44 may be disposed in the void defined by the
ultrasonic handpiece 12. The transducer 44 may comprise a plurality
of driver elements 46, such as piezoelectric crystals arranged in a
stacked configuration. The piezoelectric crystals 46 may expand and
contract based on the varied application of electricity. The
transducer 44 may comprise a tube 43 that defines a lumen 45 that
extends from the proximal end to the distal end of the transducer
44 to create a fluid passageway through the transducer 44. The tube
43 may take the form of a post. The tube 43 may extend through the
collinear longitudinal axes of the driver elements 46. A proximal
end mass 41 may be located adjacent to the proximal face of the
most proximally located driver element 46.
[0036] It is further contemplated that the transducer 44 may
alternatively include a plurality of magnetostrictive elements.
[0037] A horn 40 may be at least partially disposed within the void
defined by ultrasonic handpiece 12. The horn 40 may be coupled to
the distal end of the transducer 44. The horn 40 may be constructed
from a rigid steel alloy, titanium or similar material. In
operation, as the transducer 44 expands and contracts, the horn 40
will oscillate. The horn 40 may be removably coupled to the
transducer 44. For example, the proximal end of the horn 40 may
comprise a threaded male coupler and the distal end of the
transducer 44 may comprise a corresponding female threaded coupler.
Alternatively, the transducer 44 and the horn 40 may be permanently
coupled via a weld, adhesive, or similar bonding process. The horn
40 may be configured to define a second conduit 42 that is in fluid
communication with the lumen 45 defined by the tube 43 of the
transducer 44. Collectively, the lumen 45 through the transducer 44
and the second conduit 42 through the horn 40 form a portion of a
continuous fluid passageway that extends from the distal end of the
ultrasonic handpiece 12 to the proximal end of the ultrasonic
handpiece 12. The ultrasonic surgical handpiece assembly 10 is
constructed so that the driver elements 46 are compressed between
the proximal end mass 41 and the horn 40.
[0038] The fluid passageway through the ultrasonic handpiece 12 may
be utilized to provide irrigation fluid and/or a vacuum through the
ultrasonic handpiece 12. The distal end of the horn 40 may further
comprise a threaded coupler 38 that is configured to removably
couple the ultrasonic tip 20 to ultrasonic handpiece 12 via the
horn 40. While the threaded coupler 38 on the distal end of the
horn 40 may comprise threads configured to engage corresponding
threads on the ultrasonic tip 20, it is further contemplated that
other coupling methods may be utilized. For example, the distal end
of the horn 40 may comprise features that allow snap fit engagement
with the ultrasonic tip 20.
[0039] The control console 13 of the ultrasonic surgical handpiece
assembly 10 may be configured to source drive signals over the
cable 30 to which the ultrasonic handpiece 12 is connected. In many
but not all versions of ultrasonic surgical handpiece assembly 10,
the ultrasonic handpiece 12 and cable 30 are assembled as a single
unit. The drive signals are applied to the piezoelectric crystals
46. At any given instant, the same drive signal is applied to each
of plurality of piezoelectric crystals 46. The application of the
drive signals causes the piezoelectric crystals 46 to
simultaneously and cyclically expand and contract. A stack of
piezoelectric crystals 46 is often between 1 and 5 cm in length.
The distance, the amplitude, of movement over a single
expansion/contraction cycle of the piezoelectric crystals 46 may be
between 1 and 10 microns. The horn 40 may be configured to amplify
this movement. Consequently, the distal end of the horn 40 and, by
extension, the ultrasonic tip 20, when moving from the fully
contracted position to the fully extended position typically moves
a maximum of 1000 microns and more often 500 microns or less. Some
ultrasonic tips 20 are further designed to so that the longitudinal
extension/retraction of the ultrasonic tip 20 may also induces a
torsional movement in the cutting feature 34. When ultrasonic
handpiece 12 is actuated to cause the cyclic movement of the
ultrasonic tip 20, the cutting feature 34 is considered to be
vibrating.
[0040] The control console 13 may also include a vacuum pump and
controller, and an irrigation pump and a controller. The vacuum
pump may be coupled to the ultrasonic surgical handpiece assembly
10 via aspiration line 27. The irrigation pump may be coupled to
the ultrasonic handpiece assembly 10 via irrigation line 29.
[0041] The control console 13 may have any of the features
described in U.S. Patent Publication No. 2017/0071621 and
2018/0056328, which are hereby incorporated by reference in their
entirety.
[0042] The ultrasonic handpiece 12 may also comprise a tube 58 that
is at least partially disposed within the ultrasonic handpiece 12
and configured to define a lumen 59 through the ultrasonic
handpiece 12 for irrigation and/or suction. The tube 58 defines an
additional lumen 59 through the ultrasonic handpiece 12 to the
passageway defined by the lumen 45 of the transducer 44 and the
second conduit 42 of the horn 40. For example, the tube 58 may
define an irrigation lumen 59 through the ultrasonic handpiece 12
and the lumen 45 through the transducer 44 and the second conduit
42 through horn 40 may define an aspiration lumen 45 through the
ultrasonic handpiece 12. Alternatively, the tube 58 may define an
aspiration passageway 59 through the ultrasonic handpiece 12 and
the lumen 45 through the transducer 44 and the second conduit 42
through the horn 40 may define an irrigation passageway through the
ultrasonic handpiece 12.
[0043] As described above, the irrigation and/or the aspiration
passageways are disposed mostly within the ultrasonic handpiece 12
to provide ergonomic advantages by eliminating the one or more
tubes typically attached to the exterior of the ultrasonic
handpieces. It should be understood that while portions of the
lines that define the aspiration passageway and/or the irrigation
passageway from the proximal end of the ultrasonic surgical
handpiece assembly 10 to the distal end of the passageway may be
exposed, i.e., visible to a user during operation, there are is no
need for users to attach any irrigation lines or aspiration lines
to the sides of the ultrasonic surgical handpiece assembly 10
during use. Instead, the irrigation lines 29 and aspiration lines
27, in certain embodiments, solely attach to the proximal end, even
the rear face of the proximal end of the ultrasonic handpiece 12.
In addition, in certain embodiments, during set-up of the
ultrasonic surgical handpiece assembly 10, all of the aspiration
and irrigation connections that the sleeve includes are sourced
directly from the ultrasonic handpiece 12. In other words, there
are no irrigation or aspiration lines that couple to a side of the
sleeve 18. Thus, the ultrasonic handpiece 12 may include
connections for both irrigation and aspiration.
[0044] Referring to FIG. 4, a sectional view of a portion of the
ultrasonic handpiece 12 is illustrated. As described above, the
transducer 44 may comprise a distal end and a proximal end disposed
within the void of ultrasonic handpiece 12. The transducer 44 may
be configured to expand and contract along the longitudinal axis of
the transducer 44. The lumen 45 through the transducer 44 comprises
a distal portion and a proximal portion. The horn 40 may also be at
least partially disposed within the ultrasonic handpiece 12.
[0045] The ultrasonic handpiece 12 may further comprise a barrier
member 49 positioned within the void defined by the ultrasonic
handpiece 12 and configured to define a cavity. The transducer 44
may be encased within the barrier member 49, such that the barrier
member 49 may be configured to assist in mounting and isolating the
transducer 44 within the ultrasonic handpiece 12. The barrier
member 49 may not occupy the entirety of the void defined within
the ultrasonic handpiece 12. Therefore, the ultrasonic handpiece 12
may further comprise a potting element 47 or material that is
disposed within void defined by the ultrasonic handpiece 12. The
potting element 47 may be disposed within the void defined by the
ultrasonic handpiece 12 and exterior to the barrier member 49, such
that the potting element 47 may occupy or fill the portion of the
void within the handpiece 12 that is not occupied by the barrier
member 49 or occluded by the barrier member 49. The potting element
47 may be configured to fix the position of the barrier member 49
within the void defined by the ultrasonic handpiece 12. The potting
element 47 may also function as an insulator or dampener configured
to prevent the transfer of thermal energy (i.e., heat) and
mechanical energy (i.e., vibration) from the transducer 44 to the
user's hand.
[0046] The barrier member 49 may further define a channel 53
extending in a generally proximal direction from the proximal end
of the barrier member 49. The channel 53 forms a passageway between
the proximal end of the ultrasonic handpiece 12 and the tube 43
that defines the lumen 45 through the transducer 44. The channel 53
may further comprise a coupling portion 54, such as a hose barb or
similar fitting configured to create a friction fit, that extends
proximally from the proximal end of the ultrasonic handpiece 12 and
is configured to couple the channel 53 to the aspiration line 27 of
the control console 13.
[0047] The transducer 44 may be partially mounted in the cavity
defined by the barrier member 49 by a rear seal 48 positioned
between said proximal end of the transducer 44 and an interior
surface of the barrier member 49. The rear seal 48 may be
configured to abut said proximal end of the transducer 44 and
define a first aperture that is in fluid communication with the
lumen 45 through the transducer 44. The rear seal 48 is positioned
to help prevent moisture ingress to the volume that surrounds the
transducer 44, in between the barrier member 49 and the exterior of
the transducer 44. The rear seal 48 also functions to prevent
moisture from entering between the exterior surface of the tube 43
and the interior surface of the transducer 44. The rear seal 48 may
be formed from an elastomeric material that is resistant to heat
and vibration degradation, including those materials that can
withstand temperatures of an autoclave process.
[0048] The ultrasonic handpiece 12 may further comprise a front
seal 52 disposed radially about an exterior surface of the horn 40
to prevent moisture ingress between an interior surface of the
distal housing portion 16 and the horn 40. This is because the
exterior surface of the horn 40 will be exposed to liquid during
operation of the ultrasonic handpiece 12. The front seal 52 may
further comprise a plurality of protrusions or bumps configured to
facilitate engagement between the horn 40 and the distal housing
portion 16 and prevent ingress of moisture into the void between
the horn 40 and the distal housing portion 16 of the ultrasonic
handpiece 12.
[0049] The ultrasonic handpiece 12 may further comprise a potting
seal 50 positioned between and engaging both a distal end of the
barrier member 49 and the proximal end of the horn 40. The potting
seal 50 may also be configured to contact an interior surface of
distal housing portion 16 of the ultrasonic handpiece 12 that is
adjacent to the barrier member 49 and the proximal end of the horn
40. The potting seal 50 may be configured to abut the distal end of
the barrier member 49 and define a second aperture for receiving
the coupling feature of the horn 40. The potting seal 50 may be
configured to prevent the potting element 47 from entering the
barrier member 49 and contacting the transducer 44 during the
potting process. Once the potting element 47 is in place, the
potting element 47 in conjunction with the potting seal 50 helps to
prevent moisture from entering between the barrier member 49 and
the horn 40.
[0050] Referring to FIGS. 5 and 6, an exemplary configuration of
the distal housing portion 16 is illustrated. The distal housing
portion 16 may comprise a coupling feature 60 configured to
removably couple the distal housing portion 16 to a distal portion
of the barrier member 49 that is disposed within the proximal
housing portion 14. The coupling feature 60 may comprise a pair of
tabs configured to create a snap and/or friction fit with a
corresponding coupling feature of the barrier member 49. However,
alternative coupling features are also contemplated, such as hooks
or protrusions. The coupling feature 60 may assist in mounting
and/or positioning the barrier member 49 within the void defined by
the distal housing portion 16 and the proximal housing portion
14.
[0051] The distal housing portion 16 of the ultrasonic handpiece 12
may further comprise a flex circuit 62 that may be molded into the
distal housing portion 16. The flex circuit 62 may be constructed
from an electrically conductive material configured to transmit
electrical signals between a distal region and proximal region of
the flex circuit 62. The flex circuit 62 may comprise an attachment
portion 64 positioned at the proximal region of the flex circuit 62
and configured to couple to a processor disposed within the
ultrasonic handpiece 12 that is configured to communicate with the
control console 13. Alternatively, the attachment portion 64 of the
flex circuit 62 may be configured to couple to a wire, cable, or
similar conductor that may couple to the control console 13 via the
cable 30. The processor or wire may be configured to transport
electrical signals between the flex circuit 62 and the control
console 13 that may control the power supply, irrigation, and/or
aspiration functions of the ultrasonic handpiece 12. The flex
circuit 62 may also comprise a transceiver 66 positioned at the
distal region of the flex circuit 62. As will be described below,
the position of the transceiver 66 in the ultrasonic handpiece 12
should be tightly controlled in order to ensure that a
corresponding coil of the sleeve 18 can be consistently read when
the sleeve 18 is coupled to the ultrasonic handpiece 12.
[0052] Also illustrated in FIG. 5 is the tube 58 defining the lumen
59 described above, that is at least partially disposed within the
ultrasonic handpiece 12. The tube 58 may be at least partially
disposed within the distal housing portion 16 and the proximal
housing portion 14. The tube 58 may further comprise a coupling
feature 56, such as a hose barb or similar fitting configured to
create a friction fit, positioned at proximal end of the tube 58
and configured to couple to the tube 58 to an irrigation line 29
that is routed from the control console 13 to the ultrasonic
surgical handpiece assembly 10. The irrigation line 29 from the
console 13 may be coupled to the ultrasonic handpiece 12 via the
hose barb 56 to facilitate the flow of irrigation fluid through
tube 58 within the ultrasonic handpiece 12 to the sleeve 18 and/or
ultrasonic tip 20. In the configuration described above, the
irrigation fluid may flow from the proximal end to the distal end
of the ultrasonic handpiece 12 within the ultrasonic handpiece 12
or sleeve 18 eliminating the need for bulky irrigation lines
coupled to the side of the ultrasonic handpiece 12 or the side of
the sleeve 18. The routing of irrigation lines through the
handpiece 12 enables this configuration. Thus, neither the sleeve,
nor the ultrasonic handpiece includes an irrigation coupling part
along the sides. Alternatively, in other configurations, the tube
58 may be coupled to an aspiration line 27 via the coupling feature
56. The aspiration line 27 may be utilized to draw a vacuum through
the tube 58. The tube 58 may be in communication with the sleeve 18
and/or ultrasonic tip 20 to remove biological material and/or fluid
from the surgical site.
[0053] Referring to FIG. 6, an exploded view of the distal housing
portion 16 of the ultrasonic handpiece 12 is illustrated. The
distal housing portion 16 may comprise a first half 68 and a second
half 70 that are configured to be coupled together to form a
portion of the distal housing portion 16. Each of the first half 68
and the second half 70 may be injection-molded from
injection-molded plastic or similar lightweight and durable
material. Furthermore, each of the first half 68 and the second
half 70 may be molded to include a groove 74 or recessed portion
that forms a channel in the distal housing portion 16 when the
first half 68 and the second half 70 are coupled together. It is
also contemplated that the groove 74 may only be formed in one of
the first half 68 or the second half 70. The groove 74 may be
configured to receive at least a portion of the flex circuit 62.
The groove 74 may further comprise a cavity 72 at the distal end of
the groove 74, wherein the cavity 72 is configured to receive the
transceiver 66 at the distal region of the flex circuit 62. The
cavity 72 may comprise larger dimensions than the groove 74 to
accommodate the size of the transceiver 66 relative to the flex
circuit 62 and the cavity 72 and the groove 74 may be contiguous.
While the cavity 72 is illustrated as being positioned proximate
the distal end of the distal housing portion 16, it is contemplated
that the first and second halves 68, 70 may be configured wherein
the flex circuit 62 and the transceiver 66 to be positioned at
alternative locations. For example, the cavity 72 could be
positioned closer to the proximal end of the distal housing portion
16. In yet another configuration, the first and second halves 68,
70 may be configured to be split along a horizontal axis, as
opposed to along a vertical axis, such that the first half 68 is
positioned superior to the second half 70. In this configuration,
the groove 74 and the cavity 72 may be formed within the interface
of the first and second halves 68, 70 such that the flex circuit 62
and transceiver 66 may be positioned on the right or left side of
the distal housing portion 16.
[0054] The position of the cavity 72 should be tightly controlled
in order to enable communication between the transceiver 66 and
RFID tag 88 of the sleeve 18 (See FIG. 8). For example, the cavity
72 may be positioned within the distal housing portion 16 to reduce
the distance between the transceiver 66 and the corresponding RFID
tag 88 of the sleeve 18 when the sleeve 18 and ultrasonic handpiece
12 are coupled together. The cavity 72 is positioned to ensure that
the plane defined by the transceiver 66 is positioned substantially
parallel to the plane defined by the RFID tag 88 of the sleeve
18.
[0055] As described above, the flex circuit 62 may comprise a
transceiver 66 positioned at the distal end of the flex circuit 62.
The transceiver 66 may comprise an antenna configured to send out a
signal to a corresponding RFID tag associated with the sleeve 18
and receive a response. The flex circuit 62 may be disposed at
least partially within the groove 74 of the distal housing portion
16 when the first half 68 and the second half 70 are coupled
together. The flex circuit 62 may generally be formed as a thin
strip of ribbon including internal copper elements, such as wiring.
The configuration and structure of the flex circuit 62 may result
in the flex circuit 62 being frail or easily damaged. This can make
working with and or installing the flex circuit into the distal
housing portion 16 difficult. For example, one needs to handle the
flex circuit in a manner that protects against crushing or
breaking. One also wants to be careful to avoid operations that may
cause the layers of the flex circuit 62 to delaminate. Therefore,
the groove 74 formed in the distal housing portion 16 should avoid
sharp bends or turns and seek to provide a smooth transition along
the length of the grove 74. During the assembly process, the flex
circuit 62 is positioned within the groove 74 and the transceiver
66 within the cavity 72 prior to coupling the first half 68 and the
second half 70 of the distal housing portion 16, such that the
position of the transceiver 66 may be fixed within the distal
housing portion 16. It should be appreciated that the transducer
need not always be at the distal end of the flex circuit.
[0056] Once the first half 68 and the second half 70 of the distal
housing portion 16 have been mechanically fit together such that
the position of the transceiver 66 is fixed, the distal housing
portion 16 may be over-molded with autoclaveable plastic to produce
the final configuration of distal housing portion 16 illustrated in
the FIG. 5. Over-molding the flex circuit 62 and transceiver 66
within the distal housing portion 16 of the ultrasonic handpiece 12
with an autoclaveable plastic serves to protect the flex circuit 62
from being damaged by heat during the autoclave process utilized to
sterilize the ultrasonic handpiece 12. Furthermore, the use of
autoclaveable plastic as opposed to plastic having a lower melting
point than 150 degrees Celsius, allows the distal housing portion
16 to be repeatedly subject to autoclave sterilization processes
without experiencing significant degradation. Finally, by
positioning the flex circuit 62 within the groove 74 of the first
and second halves 68, 70 before overmolding with the autoclaveable
plastic, the flex circuit 62 is sufficiently insulated by the first
and second halves 68, 70 from the thermal energy of the melted
autoclaveable plastic such that the flex circuit 62 does not
delaminate during the overmolding process. The result of the
process described above can be shown in the device illustrated in
FIGS. 5 and 8. Autoclaveable plastic should be understood as
polymers having a melting point greater than 150 degrees
Celsius.
[0057] While the process of positioning the flex circuit 62 is
described with respect to the two halves 68, 70 of the distal
housing portion 16, it should be appreciated that a similar process
can be used with any suitable medical device housing where it is
important to precisely position a portion of a flex circuit 62,
including those medical device housings that do not include two
distinct halves.
[0058] While not illustrated, the ultrasonic handpiece 12 also
includes a memory. The memory may contain data describing the
characteristics of the ultrasonic handpiece 12. Memory may take the
form of an EPROM, an EEPROM or be included with the RFID tag 88
described above. The memory, in addition to containing data capable
of being read, is able to store data written to the memory after
manufacture of the ultrasonic handpiece 12. Ancillary components
not illustrated are mounted to the handpiece to facilitate the
reading of data from and the writing of data to the memory. These
components consist of one or more of the following: conductors;
exposed contacts/contact pins; a coil/antenna; or an isolation
circuit.
[0059] Referring to FIGS. 7-9, an exemplary configuration of the
interface between the distal housing portion 16 and the sleeve 18
and/or ultrasonic tip 20 is illustrated. FIG. 7 illustrates a front
view of an example configuration of the distal end of the distal
housing portion 16 described above. This may also be referred to as
the distal end of the ultrasonic handpiece 12. The distal end of
the ultrasonic handpiece 12 may comprise an attachment region 69
configured to serve as the interface between the ultrasonic
handpiece 12 and the sleeve 18 and the ultrasonic tip 20. The
attachment region 69 may comprise a recess 71 defined by a proximal
surface 78 and a distal surface 79 that are connected by a
plurality of walls 77 extending perpendicular to the proximal
surface 78 and the distal surface 79. The proximal surface 78 may
comprise an aperture 73 including a coupling feature 75 at the
perimeter of the aperture 73 (See FIG. 9). The coupling feature 75
may comprise a tab, lip, or similar snap fit coupling
mechanism.
[0060] The distal end of the horn 40 may be configured to partially
extend through the aperture 73 defined in the proximal surface 78,
wherein at least a portion of the horn 40 and the threaded coupler
38 are disposed within the recess 71 at the distal end of the
ultrasonic handpiece 12. The second conduit 42 that extends through
the horn 40 may similarly open to the recess 71.
[0061] The proximal surface 78 may further comprise an irrigation
coupler 76 positioned at the distal end of the tube 58 defining the
lumen 59 through the ultrasonic handpiece 12. The irrigation
coupler 76 may comprise a fitting, hose barb, or similar coupling
member for coupling the distal end of the tube 58 to a
corresponding irrigation line 29 of the sleeve 18. The irrigation
coupler 76 may be configured to be in fluid communication with the
lumen 59 disposed within the ultrasonic handpiece 12 to provide
irrigation fluid to the sleeve 18. The irrigation coupler 76 may
serve as an inlet or an outlet to transport material and/or fluid
between the ultrasonic handpiece 12 and sleeve 18.
[0062] Referring to FIG. 8, a partially exploded view of the
interface between the distal end of the ultrasonic handpiece 12 and
the sleeve 18 is illustrated. The sleeve 18 may comprise a hub 21
positioned at a proximal end of the sleeve 18 and a sleeve body 19
that extends distally from the hub 21. The sleeve 18 may comprise a
lumen 98 defined by the hub 21 and sleeve body 19 that extends the
length of sleeve 18 and is configured to surround at least a
portion of the ultrasonic tip 20 when coupled to the ultrasonic
handpiece 12. The hub 21 may comprise a protrusion 80 that extends
proximally from a distal surface 84 of the hub 21 and terminates at
a proximal surface 82. The proximal surface 82 of the protrusion 80
may be oriented to be generally parallel to the distal surface 84.
The shape of the protrusion 80 may be defined by a plurality of
external circumferential surfaces 81 or wall members that extend
between the distal surface 84 and the proximal surface 82 and are
configured to define the outer perimeter of the protrusion 80. The
external circumferential surfaces 81 may be oriented to be
generally perpendicular to the proximal surface 82 and/or the
distal surface 84. It should be appreciated the shape of the
protrusion 80 is positioned to fit closely within the recess 71,
such that the external circumferential surfaces 81 of the
protrusion 80 engage the walls 77 of the recess 71.
[0063] However, while not illustrated in the figures, it is further
contemplated that the external circumferential surfaces 81 of the
protrusion 80 may be oriented at an angle other than 90 degrees
relative to the proximal surface 82 and/or the distal surface 84 in
order to create a tapered protrusion 80. For example, the area
defined by the external circumferential surfaces 81 of the
protrusion 80 proximate the distal surface 84 may be greater than
the area of the proximal surface 82.
[0064] The hub 21 may further comprise a fitting 94 extending from
the proximal surface 82 of the protrusion 80. The fitting 94 may be
configured to couple to the corresponding fitting 76 of the
ultrasonic handpiece 12. The fitting 94 of the sleeve 18 and
corresponding fitting 76 of the ultrasonic handpiece 12 may be
configured to facilitate the exchange of fluid between the sleeve
18 and the ultrasonic handpiece 12. In particular, the fitting 76
is sized to fit within the fitting 94 when the sleeve 18 is coupled
to the ultrasonic handpiece 12. For example, irrigation fluid from
the ultrasonic handpiece 12 may be dispersed to the sleeve 18
through the connection of the fitting 94 to the fitting 76. This
eliminates the need to connect the sleeve to an irrigation line
that is separate from the ultrasonic handpiece 12, e.g., such as an
irrigation line that connects to a side of the sleeve 18.
Alternatively, a vacuum may be applied to the ultrasonic handpiece
12 configured to aspirate material from the sleeve 18 through the
fittings 94 and 76 when coupled in an alternative
configuration.
[0065] The sleeve 18 may further comprise a conduit 96 formed in
the sleeve body 19 that runs adjacent to the lumen 98 of the sleeve
18. The fitting 94 may be coupled to the proximal end of the
conduit 96. The conduit 96 may be configured to channel irrigation
fluid through the sleeve 18 separate from the lumen 98 of the
sleeve 18. The conduit 96 may be routed in various ways through the
sleeve 18.
[0066] The hub 21 may further comprise a cavity 86 in the
protrusion 80 that that includes an opening in the proximal surface
82 of the protrusion 80. The cavity 86 may be configured to at
least partially enclose a tag 88, antenna, transceiver, or similar
wireless communication device that is configured to communicate
with the transceiver 66 disposed in the distal housing portion 16
of the ultrasonic handpiece 12. For example, the tag 88 may
comprise an RFID tag 88 that may be inserted and/or disposed within
the cavity 86. While the figures illustrate the cavity 86 and RFID
tag 88 as being positioned generally near the proximate end of the
sleeve 18, it should be understood that the cavity 86 and RFID tag
88 may be positioned at other locations on or within the sleeve 18.
For example, the RFID tag 88 may be positioned within one of the
other external circumferential surfaces 81A, 81B, or 81D of the
protrusion 80. Alternatively, the cavity 86 and RFID tag 88 may be
positioned within the distal surface 84 of the hub 21. The RFID tag
88 may include a memory unit that stores data and/or information
related to one or more properties or characteristics related to the
sleeve 18 and ultrasonic tip 20. For example, the RFID tag 88 may
comprise information identifying the type of cutting feature 34
disposed on the distal end of the ultrasonic tip 20. The RFID tag
88 may also comprise information identifying the type of sleeve 18.
This information may be communicated to the ultrasonic handpiece 12
and subsequently the console 13 so that the console 13 may modify
power settings, irrigation settings, aspiration settings, and/or
other settings intended to optimize the efficiency of the cutting
feature 34 of the ultrasonic tip 20. This may include control
parameters that are not specific to the power and tip to the
ultrasonic handpiece 12 compatibility settings. The RFID tag 88 may
also be used to prevent customers from reusing ultrasonic tip 20
and/or sleeve 18 as part of a sterilization standard or procedure.
For example, the ultrasonic tip 20 and sleeve 18 may be configured
as a single use component that is not intended to be sterilized and
reused. The RFID tag 88 also includes a coil 89. The shape of the
protrusion 80 and the recess 71 are arranged such that the plane
defined by the coil 89 of the RFID tag 88 is generally parallel to
the plane defined by the transceiver 66.
[0067] The RFID tag 88 in the sleeve 18 may be understood as the
tip memory. The ultrasonic tip 20 and the sleeve 18 are typically
packaged together in a kit. The data contained in the RFID tag 88
may be used control actuation of the ultrasonic tip 20. The coil 89
embedded in the sleeve 18 is coupled to memory unit of the RFID tag
88. As described above, the RFID tag 88 may be used to prevent
customers from reusing ultrasonic tip 20 and/or sleeve 18. In
combination with the memory unit, the RFID tag 88 may be further
configured to track and/or count the number of uses and limit the
number of times a tip is used. For example, the RFID tag 88 may be
configured to store on the memory unit the number and/or amount of
time the ultrasonic tip 20 and sleeve 18 are operated. The RFID tag
88 and memory unit may be configured to prevent actuation of the
tip a define number of uses. The defined number of uses may be
passed on wear and effectiveness of the ultrasonic tip 20 and/or
sleeve 18, in order to prevent or predict failure.
[0068] As illustrated in FIG. 9, the tag 88 may be secured in the
cavity 86 by a pin 89. The pin 89 may comprise a plastic or alloy
material and be configured to create a friction fit within the
opening of the cavity 86 to secure the RFID tag 88 within the
cavity 86 and protect it from being damaged. Alternatively, the pin
89 may comprise a seal such as an elastomeric O-ring. In yet
another configuration, the pin 89 may comprise an epoxy, glue,
sealant, or similar compound configured to secure the tag 88 within
the cavity 86 and protect the tag from damage. It is further
contemplated that the RFID tag 88 may be injection molded or heat
staked into the sleeve 18. The RFID may also take other forms of
tags.
[0069] The protrusion 80 may be configured in a complementary shape
to the one defined by the recess 71 at the distal end of the
ultrasonic handpiece 12, wherein the protrusion 80 is configured to
be disposed within the recess 71 when the sleeve 18 is coupled to
the ultrasonic handpiece 12. Furthermore, the shape of the recess
71 and the protrusion 80 may be configured to align the sleeve 18
relative to the ultrasonic handpiece 12, as well as prevent
rotational movement of the sleeve 18 relative to the ultrasonic
handpiece 12. For example, as illustrated in FIG. 8, the recess 71
of the ultrasonic handpiece 12 comprises a plurality of walls 77
that define the perimeter of the recess 71. In the example
configuration of the recess 71 illustrated in FIGS. 7-8, the walls
77A, 77B, 77C, and 77D define a doghouse-like shape, wherein you
have two opposing walls 77A, 77B, that are generally parallel to
one another. The two opposing walls 77A, 77B are connected by a
third wall 77C that is generally perpendicular to the two opposing
walls 77A, 77B. A fourth wall 77D, that connects the two opposing
walls 77A, 77B opposite the third wall 77C, may comprise a
generally arch-like shape. The plurality of external
circumferential surfaces 81A, 81B, 81C, and 81D that define the
outer perimeter of the protrusion 80 may then be configured to
define a doghouse-like shape that corresponds to the shape of the
recess 71. While not illustrated in the figures, it is contemplated
that the walls 77A, 77B, 77C, and 77D of the recess 71 and the
corresponding external circumferential surfaces 81A, 81B, 81C, and
81D of the protrusion 80 may be configured to define alternative
shapes. For example, the walls 77 and external circumferential
surfaces 81 may define a rectangular shape, a star shape, an oval
shape, a triangular shape or other similar shape. While the
protrusion 80 and the recess 71 illustrated in the figures include
complementary shapes, it is further also contemplated that the
protrusion 80 and the recess 71 may have slightly different shapes,
so long as the protrusion 80 may be disposed within the recess 71.
For example, the protrusion 80 on the sleeve 18 may be configured
to comprise several more external circumferential surfaces 81 to
the protrusion by creating a chamfer between 81C and 81A and/or 81B
and it would still insert and function in the ultrasonic handpiece
12.
[0070] The shape of the protrusion 80 and the recess 71 may further
be configured to orient the tag 88 that is disposed in the cavity
86 of the hub 21 relative to the transceiver 66 disposed in the
distal housing portion 16 of the ultrasonic handpiece 12. Utilizing
the shape of the protrusion 80 and the recess 71 to orient the tag
88 relative to the transceiver 66 can improve the reliable
establishment of communication between the tag 88 relative and the
transceiver 66. For example, as illustrated in FIG. 9, the tag 88
and the transceiver 66 are positioned such that the tag 88 and the
transceiver 88 at least partially overlap in an axial sense when
the sleeve 18 is coupled to the ultrasonic handpiece 12.
Furthermore, the cavity 86 in the hub 21 and the cavity 72 in the
distal housing portion 16 of the ultrasonic handpiece 12 may be
oriented such that a first longitudinal axis of the tag 88 and a
second longitudinal axis of transceiver 66 are generally parallel
to one another. The protrusion 80 and the distal housing portion 16
may further be configured to reduce the distance between the cavity
86 in the hub 21 and the cavity 72 in the distal housing portion 16
to further improve communication between the tag 88 and the
transceiver 66.
[0071] The hub 21 may further comprise a plurality of retention
fingers 90 that extend distally from the proximal surface 82 of the
protrusion 80. The plurality of retention fingers 90 may be spaced
about the perimeter of the lumen 98 defined in the proximal surface
82. The plurality of retention fingers 90 may further comprise a
tab 92, bump, or protrusion configured to engage the coupling
feature 75 at the perimeter of the aperture 73 in the proximal
surface 78 of the recess 71 in the ultrasonic handpiece 12. The tab
92 of each of the plurality of retention fingers 90 may engage the
coupling feature 75 of the recess 71 to create a snap-fit and/or
friction fit to removably couple the sleeve 18 to the ultrasonic
handpiece 12. The plurality of retention fingers 92 may comprise a
very compliant material like a silicone rubber, or a metal material
such as a leaf spring. While not illustrated in the figures, it is
contemplated that the sleeve 18 may be coupled to the ultrasonic
handpiece 12 in a number of other ways. For example, the hub 21 hub
may be configured without and retention fingers 90, and the
irrigation coupler 76 of the ultrasonic handpiece 12 may be mated
with the irrigation fitting 94 of the sleeve 18 to form the primary
retention mechanism. In yet another configuration, the protrusion
80 may comprise a compliant material, which contains the RFID tag
88 despised within a slit in the material, and the protrusion 80
may create an interference fit with the cavity 71.
[0072] Referring to FIG. 9, a sectional view of an example
configuration of the interface between the distal housing portion
16 of the ultrasonic handpiece 12 and the sleeve 18 and ultrasonic
tip 20 is illustrated. As illustrated in FIG. 9, the distal surface
79 of the distal housing portion 16 may abut the distal surface 84
of the protrusion 80 when the sleeve 18 is coupled to the
ultrasonic handpiece 12. This may assist in forming a stable
connection between the sleeve 18 to the ultrasonic handpiece 12.
Similarly, the proximal surface 78 of the distal housing portion 16
may abut the proximal surface 82 of the protrusion 80 when the
protrusion 80 is disposed within the recess 71 to couple the sleeve
18 to the ultrasonic handpiece 12. However, it is also possible
that there may be a gap between the proximal surface 78 of the
distal housing portion 16 and the proximal surface 82 of the
protrusion 80 when the distal surface 79 of the distal housing
portion 16 abuts the distal surface 84 of the protrusion 80.
[0073] In operation, the method of coupling the sleeve 18 to the
ultrasonic handpiece 12 may comprise providing the ultrasonic
handpiece 12 described above, wherein the ultrasonic handpiece 12
includes the irrigation tube 58 configured to communicate
irrigation fluid through the ultrasonic handpiece 12. The
ultrasonic handpiece 12 may also include the attachment portion 69
positioned proximate the distal end of the ultrasonic handpiece 12.
The attachment portion 69 may comprise the recess 71 describes
above, wherein the recess is defined by a plurality of side walls
77 configured to define a void, such as an asymmetric void. The
attachment region 69 may also comprise an aperture or similar
attachment element.
[0074] The method of coupling the sleeve 18 to the ultrasonic
handpiece 12 may further comprise providing the sleeve 18 described
above, wherein the sleeve 18 comprises the hub 21 that includes a
proximal surface 82 and a distal surface 84. The proximal surface
82 may optionally comprise one or more retention fingers 90 and be
configured to define an asymmetrical protrusion 80 extending
proximally from the distal surface 84. The protrusion 80 may be
sized to be inserted within the recess 71 of the ultrasonic
handpiece 12.
[0075] The method of coupling the sleeve 18 to the ultrasonic
handpiece 12 may further comprise coupling the ultrasonic handpiece
12 to the sleeve 18 by inserting the asymmetrical protrusion 80
into the asymmetrical void defined by the attachment portion 69
such that the one or more retention fingers 90 engage the perimeter
of the aperture in the distal housing portion 16 to create an
interference fit between the sleeve 18 to the ultrasonic handpiece.
As the asymmetrical protrusion 80 is inserted into the asymmetrical
void defined by the attachment portion 69, the irrigation coupler
76 of the ultrasonic handpiece 12 may be mated with the irrigation
fitting 94 of the sleeve 18 to form an irrigation passageway
between the ultrasonic handpiece 12 and the sleeve 18 without
separately connecting an irrigation line to the irrigation sleeve
18. Thus, the irrigation and the aspiration lines may be coupled to
the sleeve and the sleeve may be coupled to the ultrasonic
handpiece with a single step--inserting the protrusion of the
sleeve into the recess of the ultrasonic handpiece.
[0076] The method of coupling the sleeve 18 to the ultrasonic
handpiece 12 may further comprise the step of providing the
ultrasonic tip 20 described above, wherein the ultrasonic tip 20
comprises a threaded coupler 104 at the distal end of the
ultrasonic tip 20 configured to removably secure the ultrasonic tip
20 to the threaded coupler 38 of the ultrasonic handpiece 12. The
ultrasonic tip 20 may further comprise a cutting feature 34 at the
distal end of the ultrasonic tip 20. The method may then comprise
coupling the ultrasonic tip 20 to the ultrasonic handpiece 12 prior
to the step of coupling the ultrasonic handpiece 12 to the
irrigation sleeve 18.
[0077] The method of coupling the sleeve 18 to the ultrasonic
handpiece 12 may further comprise the step of inserting the first
irrigation coupler 76 on a distal end of the irrigation conduit or
tube 58 of the ultrasonic handpiece 12 into a corresponding
irrigation fitting 94 on the irrigation sleeve 18 as the
asymmetrical protrusion 80 is inserted into the asymmetrical void
defined in the attachment portion 69, wherein the irrigation
fitting 94 is in fluid communication with the conduit 96 of the
sleeve 18 and is configured to provide irrigation fluid to the
ultrasonic tip 20.
[0078] Referring to FIGS. 10, 11A, and 11B, an example
configuration of the ultrasonic tip 20 disposed within the sleeve
18 is illustrated. Referring to FIG. 11B, a sectional view of the
ultrasonic tip 20 disposed within the sleeve 18 is illustrated. As
described above, the sleeve 18 may comprise the conduit 96 formed
in the sleeve body 19 and runs adjacent to the lumen 98 of the
sleeve 18. The distal end of the conduit 96 may terminate at an
aperture 108 or nozzle positioned on an interior surface of the
lumen 98. The aperture 108 may configured to direct fluid radially
inward toward the center of the lumen 98. The fluid may then be
applied to an exterior surface of the ultrasonic tip 20 and/or
directed toward the distal end of the sleeve 18, wherein the fluid
may exit the lumen 98 and be applied to the surgical site.
[0079] The sleeve 18 may further comprise a seal 100, such as
O-ring, disposed within the lumen 98 and configured to contact a
portion of the ultrasonic tip 20 when the sleeve 18 is coupled to
the ultrasonic handpiece 12 and the ultrasonic tip 20 is coupled to
the ultrasonic handpiece 12. The seal 100 may be configured to
create a fluid seal between the interior surface of the lumen 98
and the exterior surface of the ultrasonic tip 20. For example, the
seal 100 may be configured to prevent fluid that is between the
interior surface of the lumen 98 and the exterior surface of the
ultrasonic tip 20 distal of the seal 100 from flowing proximal of
the seal 100.
[0080] The ultrasonic tip 20 may comprise a distal end and a
proximal end. The ultrasonic tip 20 may include a cutting feature
34 at the distal end of ultrasonic tip 20 and a coupling feature
104, positioned at the proximate end. The coupling feature 104 may
be configured to engage the threaded coupler 38 of the horn 40 to
removably couple the ultrasonic tip 20 to the ultrasonic handpiece
12. It should be understood that the coupling feature 104 of the
ultrasonic tip 20 should be configured to engage the threaded
coupler 38 of the horn 40. Thus, if a coupling arrangement other
than complementary threads is utilized, the coupling features 104,
38 of the ultrasonic tip 20 and the horn 40 are suitable to engage
one another.
[0081] The ultrasonic tip 20 may be configured to define a lumen
102 that extends from the proximal end to the distal end of the
ultrasonic tip 20. The lumen 102 may be configured to be in fluid
communication with the fluid passageway through the ultrasonic
handpiece 12 that is defined by the conduit 42 of the horn 40 and
the lumen 45 of the transducer 44 when the ultrasonic tip 20 is
coupled to the ultrasonic handpiece 12. The lumen 102 may be
configured to provide irrigation and/or suction at the surgical
site based on the system that is coupled to the fluid passageway
through the ultrasonic handpiece 12 that is defined by the conduit
42 of the horn 40 and the lumen 45 of the transducer 44. For
example, if an irrigation system is coupled to the fluid passageway
through the ultrasonic handpiece 12 that is defined by the conduit
42 of the horn 40 and the lumen 45 of the transducer 44, the lumen
102 may be configured to provide irrigation fluid to the surgical
site proximate the cutting feature 34. Alternatively, if an
aspiration system is coupled to the fluid passageway through the
ultrasonic handpiece 12 that is defined by the conduit 42 of the
horn 40 and the lumen 45 of the transducer 44, the lumen 102 may
configured to remove fluid and/or material from the surgical site
proximate the cutting feature 34.
[0082] The ultrasonic tip 20 may also comprise an aperture 106 that
is configured to be in fluid communication with the lumen 102. The
aperture 106 may be positioned between the proximal end and distal
end of the ultrasonic tip 20 such that the aperture 106 is distal
of the seal 100 of the sleeve 18 when the ultrasonic tip 20 is
disposed within the lumen 98 of the sleeve 18. Furthermore, the
aperture 106 may positioned on the ultrasonic tip 20 such that the
aperture 106 is surrounded by the sleeve 18 when the ultrasonic tip
20 is disposed within the lumen 98 of the sleeve 18. For example,
the aperture 106 may be positioned on the ultrasonic tip 20 so that
the aperture 106 is proximal of the distal end of the sleeve 18
when the ultrasonic tip 20 is disposed within the lumen 98 of the
sleeve 18.
[0083] The ultrasonic tip 20 may further comprise a resonator 105
positioned between the proximal end and the distal end of the
ultrasonic tip 20. This The resonator 105 may be configured to
translate the longitudinal vibration transmitted from the
transducer 44 to the ultrasonic tip 20 via the mechanical
connection created by the horn 40 into longitudinal and torsional
motion of the ultrasonic tip 20 distal to the resonator 105. For
example, as the transducer 44 expands and contracts, a vibration is
created that is transmitted to the ultrasonic tip 20 via the horn
40. The portion of the ultrasonic tip 20 that is proximal to the
resonator 105 experiences a longitudinal motion. The resonator 105
may then translates the longitudinal motion of the transducer 44
and horn 40 into a longitudinal and torsional torsion motion in the
portion of the ultrasonic tip 20 that is distal to the resonator
105. The resonator 105 may comprise a non-homogeneous cross
sectional region created by grooves in the outer surface of the
ultrasonic tip 20. The grooves may be oriented in a generally
spiral-like and helical configuration on the outer surface of the
ultrasonic tip 20. This may be accomplished but cutting the grooves
in a spiral-like or helical pattern on the outer surface of the
ultrasonic tip 20. Alternatively, the spiral-like or helical
pattern of the grooves may be accomplished by cutting straight
grooves in the outer surface of the ultrasonic tip 20, wherein the
grooves are generally parallel to the longitudinal axis of the
ultrasonic tip 20, and the ultrasonic tip 20 may then be twisted to
create the spiral-like or helical pattern of the grooves.
[0084] Referring to FIGS. 12-16, an example configuration of the
tubing connector 22 for use with the ultrasonic handpiece 12 as
part of the ultrasonic surgical handpiece assembly 10 is
illustrated. The tubing connector 22 may comprise a base 24
including a distal end and a proximal end. The base 24 may be
constructed of a rigid material such as a plastic. Alternatively,
the base 24 may be constructed of a flexible material or resilient
material such as an elastomer.
[0085] The base 24 may be configured to define one or two lumens
112, 114 that extend through the base 24. The lumens 112, 114 may
define a fluid passageway through the base 24 of the tubing
connector 22 and be configured to be in fluid communication with
one or more conduits or lumens through the ultrasonic handpiece 12.
For example, a first lumen 112 may be configured to be in fluid
communication with the passageway that is formed by the conduit 42
of the horn 40 and the lumen 45 of the transducer 44 when the
tubing connector 22 is coupled to the ultrasonic handpiece 12.
Additionally, a second lumen 114 may be configured to be in fluid
communication with the lumen 59 that is disposed within the
ultrasonic handpiece 12 when the tubing connector 22 is coupled to
the ultrasonic handpiece 12.
[0086] The base 24 may also define a groove 110 in a perimeter of
the base 24 that extends between the distal end and the proximal
end of the base 24. The groove 110 may be configured to receive the
cable 30, wiring harness, or similar conductor that extends
proximally from the proximal end of the ultrasonic handpiece 12.
For example, the groove 110 of the tubing connector may be
configured to receive and partially surround the cable 30, as
illustrated in FIG. 1. The groove 110 may be shaped and/or
configured to removably couple the base 24 of the tubing connector
22 to the cable 30 via a friction fit or interference fit. For
example, the groove 110 may comprise a U-like or crescent shape,
wherein the width of the opening of the groove 110 at the surface
of the base 24 is less than the maximum width of the cable 30.
[0087] The tubing connector 22 may further comprise a resilient
member 26 that extends proximally from the base 24 and is
configured to receive the aspiration line 27. The resilient member
26 and base 24 may be formed as a unitary component, wherein the
resilient member 26 defines a portion of the lumen 112 through the
base 24. The resilient member 26 may be configured such that the
aspiration line 27 may be inserted within the lumen 112 at the
proximal end of the resilient member 26. The aspiration line 27 may
for a friction fit within the lumen of the resilient member.
Alternatively, the aspiration line 27 may be coupled to the
resilient member 26 using a glue, epoxy, or similar adhesive
configured to create a chemical bond.
[0088] While not illustrated, it is also contemplated that the
resilient member 26 may be removably coupled to the base 24. For
example, a distal end of the resilient member 26 may be configured
to create a friction with the base 24 when inserted in the lumen
112.
[0089] While the figures illustrate the aspiration line 27 and/or
the irrigation line 29 as being inserted directly within the lumens
112, 114 defined in the base 24 of the tubing connector 22, if is
further contemplated that the aspiration line 27 and/or the
irrigation line 29 may be coupled to the base 24 by a hose barb or
similar fitting. For example, proximal end of a hose barb may
inserted in the opening of the aspiration line 27 and/or the
irrigation line 29. The proximal end of the hose barb may then be
inserted within the respective lumens 112, 114 that are defined in
the base 24. The hose barb(s) may be coupled to the base 24 via
friction fit within the lumens 112, 114, or the hose barb(s) may be
coupled to the base 24 using an epoxy, glue, sealant, or similar
adhesive.
[0090] The base 24 may be configured to be removably coupled the
proximal end of the ultrasonic handpiece 12 via and interference
fit. The interference fit may be created between the coupling
feature 56 of the irrigation tube 58 and the coupling portion 54 of
the channel 53 and the respective lumens 112, 114. For example, the
coupling feature 56 and coupling portion 54 may each comprise a
hose barb or similar fitting configured to be inserted in the
corresponding lumens 112, 114 to create a friction fit that
removably secures the tubing connector 22 to the proximal end of
the ultrasonic handpiece 12.
[0091] Alternatively, while not illustrated in the figures, it is
contemplated that the distal end of the base 24 may comprise a
retention feature such as a tab or finger configured to create a
snap-fit with the proximal end of the ultrasonic handpiece 12. For
example, the retention feature may comprise a tab or protrusion
that encircles a perimeter of the distal end of the base 24 and is
configured to engage the proximal end of the ultrasonic handpiece
12 to removably couple the tubing connector 22 to the ultrasonic
handpiece 12 via a snap fit.
[0092] The tubing connector 22 may serve as a means of quickly
attaching and detaching both the irrigation line 29 and the
aspiration line 27 to the proximal end of the ultrasonic handpiece
12. Furthermore, the tubing connector 22 may removably secure the
irrigation line and/or aspiration lines 29, 27 to the ultrasonic
handpiece 12 in a manner that reduces the stress on the lines
proximate the ultrasonic handpiece 12. The tubing connector 22 may
reduce bending and/or kinking of the lines proximate the ultrasonic
handpiece 12. For example, the resilient member may comprise a
resilient material configured to support the aspiration line 17
and/or resist bending or kinking the aspiration line 17.
Furthermore, the proximal offset created by the resilient member
extending proximally from the base 24 offsets the location where
the aspiration line 27 and the irrigation line 29 are coupled to
the base 24. This may prevent tangling of the lines as the drape
off the proximal end of the tubing connector 22. This serves to
provide support to the lines 27, 29 to resists bending of the line
27, 29 proximate the ultrasonic handpiece 12 to reduce the
occurrence of sharp bends in the lines 27, 29 that may restrict
flow through the lines 27, 29.
CLAUSES
[0093] i. A method of assembling an ultrasonic surgical handpiece
without using separate irrigation connections to a tip sleeve, said
method comprising:
[0094] providing a housing including an irrigation conduit
configured to communicate irrigation fluid through the ultrasonic
surgical handpiece and an attachment region in the form of a recess
in a distal end of the housing,
[0095] providing an irrigation sleeve comprising a hub including a
proximal portion and a distal portion, the proximal portion
defining a protrusion extending proximally from the distal portion
and sized to be inserted within the recess of the housing; and
[0096] coupling the housing to the irrigation sleeve by inserting
the protrusion into the recess to provide irrigation fluid to the
irrigation sleeve without separately connecting an irrigation line
to the irrigation sleeve.
ii. A sleeve for use with an ultrasonic handpiece including a
coupling housing comprising a handpiece transceiver and configured
to surround a portion of an ultrasonic tip including a cutting
feature, said sleeve comprising:
[0097] a hub comprising a proximal portion, a distal portion, and a
first lumen extending through said hub;
[0098] a tube body comprising a distal end and a proximal end, said
tube body extending from said distal portion of said hub and
configured to define a second lumen in fluid communication with
said first lumen of said hub, said second lumen configured to
surround the portion of the ultrasonic tip;
[0099] a tube aperture in an interior surface of said second lumen,
said tube aperture positioned at an intermediate point along said
second lumen between said proximal end and distal end of said tube
body and such that said tube aperture is facing inward towards said
second lumen;
[0100] an irrigation conduit adjacent to said second lumen, said
irrigation conduit configured to extend from said proximal end of
said tube body to said tube aperture;
[0101] an irrigation aperture and a tip aperture in said first
face, said tip aperture configured to be in communication with said
first lumen;
[0102] an irrigation fitting positioned within said irrigation
aperture of said first face of said hub and in fluid communication
with said irrigation tube;
[0103] a cavity defined in said proximal portion of said hub, said
cavity comprising an opening in a first surface; and
[0104] a sleeve transceiver positioned within said cavity and
configured to communicate with the corresponding handpiece
transceiver.
iii. An ultrasonic handpiece assembly for use with an elongated
cutting instrument/element, said assembly comprising:
[0105] an ultrasonic handpiece comprising:
a housing comprising a proximal end and an opposing distal end,
said housing defining a volume, said distal end having a distal
face; a transducer configured to define a first conduit, said
transducer at least partially disposed within said volume defined
by said housing; a horn comprising a first end and an opposing
second end, said horn configured to be at least partially disposed
within said volume defined by said housing; a second conduit in
said horn configured to extend between said first end and said
second end of said horn; an irrigation outlet fitting extending
from said distal end of said housing and configured to discharge
irrigation fluid from said housing;
[0106] a coupler on said second end of said horn configured to
engage the elongated cutting instrument;
a recess in said distal end of said housing; and a handpiece
transceiver comprising a handpiece coil; an irrigation sleeve
comprising: a hub comprising a proximal portion and a distal
portion, said proximal portion configured to define a protrusion
sized to be inserted within said recess of said housing; an
abutment portion configured to contact said distal face of said
ultrasonic handpiece when said protrusion is inserted in said
recess of said housing; a sleeve transceiver comprising a sleeve
coil and a memory unit, the memory unit storing information
pertaining to the optimal driving parameter for the elongated
cutting instrument; and wherein said sleeve transceiver is located
in a cavity defined in said hub such that second axis of said
sleeve coil is aligned with the handpiece coil. iv. A method of
making a surgical handpiece with a flex circuit having an antenna,
said method comprising:
[0107] providing an internal flex circuit having an antenna at a
distal end of said internal flex circuit;
[0108] providing a first housing component and a second housing
component, wherein the first and second housing components are
injection molded such that one of the first and second housing
components defines a void and one of the first and second housing
components comprises an irrigation conduit configured to
communicate irrigation fluid through the surgical handpiece;
[0109] positioning the internal flex circuit within the void of one
of the first housing component and the second housing
component;
[0110] securing the first housing component to the second housing
component to fix the internal flex circuit into position; and
[0111] overmolding the first housing component, the second housing
component, and a portion of the internal flex circuit with an
autoclaveable plastic to fix the location of the antenna of the
internal flex circuit in the first and second housing
components
v. The method of clause iv, further comprising the initial step of
injection molding the first housing component and the second
housing component. vi. The method of clause v, wherein the first
housing component and the second housing component are injection
molded to comprise corresponding channels extending longitudinally
along the length of each of the first housing component and the
second housing component, wherein the corresponding channels define
the void when the first housing component and the second housing
component are secured together. vii. The method of clause vi,
wherein the step of positioning the internal flex circuit within
the void comprises inserting a portion of said internal flex
circuit in the channel of the first housing component or the second
housing component prior to securing the first housing component to
the second housing component. viii. The method of any of clauses
iv-vii, further comprising the step of coupling a proximal end of
the flex circuit to a processor, wherein said processor is
configured to communicate with the antenna at the distal end of the
flex circuit. ix. A method of making a surgical handpiece with a
flex circuit having an antenna, said method comprising:
[0112] providing an internal flex circuit having a sensor;
[0113] providing a first housing component and a second housing
component, wherein the first and second housing components are
injection molded such that one of the first and second housing
components defines a void and one of the first and second housing
components comprises an irrigation conduit configured to
communicate irrigation fluid through the surgical handpiece;
[0114] positioning the internal flex circuit within the void of one
of the first housing component and the second housing
component;
[0115] securing the first housing component to the second housing
component to fix the internal flex circuit into position; and
[0116] overmolding the first housing component, the second housing
component, and a portion of the internal flex circuit with an
autoclaveable plastic to fix the location of the sensor of the
internal flex circuit in the first and second housing
components.
x. A sleeve for use with an ultrasonic handpiece including a
coupling housing comprising a handpiece transceiver and configured
to surround a portion of an ultrasonic tip including a cutting
feature, said sleeve comprising:
[0117] a hub comprising a proximal portion, a distal portion, and a
first lumen extending through said hub, said proximal portion
having a first face configured to abut the ultrasonic handpiece and
a second face positioned distally of said first face;
[0118] a tube body comprising a distal end and a proximal end, said
tube body extending from said distal portion of said hub and
configured to define a second lumen in fluid communication with
said first lumen of said hub, said second lumen configured to
surround the portion of the ultrasonic tip;
[0119] a tube aperture in an interior surface of said second lumen,
said tube aperture positioned at an intermediate point along said
second lumen between said proximal end and distal end of said tube
body and such that said tube aperture is facing inward towards said
second lumen;
[0120] an irrigation conduit adjacent to said second lumen, said
irrigation conduit configured to extend from said proximal end of
said tube body to said tube aperture;
[0121] an irrigation aperture and a tip aperture in said first
face, said tip aperture configured to be in communication with said
first lumen;
[0122] an irrigation fitting positioned within said irrigation
aperture of said first face of said hub and in fluid communication
with said irrigation conduit;
[0123] at least one retention finger protruding proximally from
said first face, said retention finger configured to engage the
coupling housing of the ultrasonic handpiece;
[0124] a cavity defined in said proximal portion of said hub, said
cavity comprising an opening in a first surface; and
[0125] a sleeve transceiver positioned within said cavity and
configured to communicate with the corresponding handpiece
transceiver.
xi. The sleeve of clause x, wherein said proximal portion comprises
an asymmetrical shape and is configured to be inserted into the
coupling housing of the ultrasonic handpiece. xii. The sleeve of
clause xi, wherein the proximal portion comprises:
[0126] a first wall and a third wall oriented in parallel to one
another;
[0127] a second wall extending between said first wall and said
third wall, said second wall oriented to be generally perpendicular
to said first wall and said third wall;
[0128] a fourth wall extending between said first wall and said
third wall opposite said second wall, said fourth wall comprising a
generally arced shape;
[0129] wherein said first wall, said second wall, said third wall,
and said fourth wall define said asymmetrical shape of said
proximal portion.
xiii. The sleeve of any of clauses x-xii, wherein said first face
and said second face are oriented in the same direction. xiv. The
sleeve of any of clauses x-xiii, wherein said first face and said
second face are oriented to be parallel to one another. xv. The
sleeve of any of clauses x-xiv, wherein said irrigation fitting
defines a third lumen configured to receive a corresponding barb of
the ultrasonic handpiece to provide irrigation fluid to said
sleeve. xvi. The sleeve of any of clauses x-xv, further comprising
a seal positioned within said opening of said cavity, said seal
configured to secure said sleeve transceiver within said cavity.
xvii. The sleeve of any of clauses x-xvi, wherein said sleeve
transceiver comprises a first axis and said sleeve transceiver is
positioned within said cavity such that said first axis is
generally perpendicular to a second axis defined by said first
face. xviii. The sleeve of any of clauses x-xvii, wherein said
sleeve transceiver further comprises a memory, said memory
configured to store data related to one or more characteristics
related to the ultrasonic tip. xix. An ultrasonic surgical
handpiece for use with an ultrasonic tip assembly including a
sleeve comprising at least one retention member, said ultrasonic
surgical handpiece comprising:
[0130] a housing comprising a proximal end and an opposing distal
end, said housing configured to define a volume;
[0131] a transducer at least partially disposed within said volume
defined by said housing;
[0132] a horn comprising a first end and an opposing second end and
configured to be at least partially disposed within said volume
defined by said housing, said first end of said horn operatively
coupled to said transducer;
[0133] wherein said transducer is configured to vibrate/oscillate
said horn when operated;
[0134] an attachment region formed in said distal end of said
housing, said attachment region defining a recess comprising a face
and a plurality of side walls configured to receive the sleeve;
[0135] an attachment element in said face of said recess, said
attachment element configured to receive the at least one retention
member of the sleeve to removably couple the sleeve to said
ultrasonic surgical handpiece;
[0136] a first fitting extending from said face of said recess and
configured to removably couple with the sleeve to provide
irrigation to the sleeve; and
[0137] wherein said second end of said horn is configured to
protrude from said face.
xx. The ultrasonic surgical handpiece of clause xix, wherein said
plurality of side walls comprises a first wall, a second wall, a
third wall, and a fourth wall extending from an outer perimeter of
said face;
[0138] wherein said first wall and said third wall are positioned
to be generally parallel to one another; and
[0139] wherein said second wall and said fourth wall are positioned
to be generally parallel to one another and configured to extend
between opposing ends of said first wall and said third wall.
xxi. The ultrasonic surgical handpiece of clause xx, wherein said
fourth wall comprises a generally hemispherical shape and extends
between said first wall and said third wall opposite said second
wall. xxii. The ultrasonic surgical handpiece of clauses xx or xxi,
wherein said second wall further comprises a cavity configured to
embed a handpiece transceiver within said second wall, said
handpiece transceiver comprising an axis;
[0140] wherein said handpiece transceiver is positioned within said
cavity such that said axis is parallel to an interior surface of
said second wall.
xxiii. The ultrasonic surgical handpiece of any of clauses
xix-xxii, wherein said first fitting is a male fitting configured
to be received by a corresponding female fitting of the sleeve.
xxiv. The ultrasonic surgical handpiece of any of clauses
xix-xxiii, wherein said attachment element comprises an aperture in
said face, said aperture configured to provide a friction fit with
a tab on the at least one retention member of the sleeve. xxv. An
ultrasonic handpiece assembly for use with an elongated cutting
instrument including an aspiration lumen extending the length of
the elongated cutting instrument, said assembly comprising:
[0141] an ultrasonic handpiece comprising: [0142] a housing
comprising a proximal end and an opposing distal end, said housing
defining a volume, said distal end having a distal face; [0143] a
transducer configured to define a first conduit, said transducer at
least partially disposed within said volume defined by said
housing; [0144] a horn comprising a first end and an opposing
second end, said horn configured to be at least partially disposed
within said volume defined by said housing; [0145] a second conduit
in said horn configured to extend between said first end and said
second end of said horn; [0146] a threaded coupler on said second
end of said horn configured to extend from said distal end of said
housing and removably couple said horn to the elongated cutting
instrument; [0147] an irrigation outlet fitting extending from said
distal end of said housing and configured to discharge irrigation
fluid from said housing;
[0148] an irrigation sleeve comprising: [0149] a hub defining a
first lumen and comprising an irrigation inlet fitting, said
irrigation inlet fitting configured to engage said irrigation
outlet fitting to receive irrigation fluid discharged from said
ultrasonic handpiece; [0150] a sleeve body extending distally from
said hub, said sleeve body defining a second lumen configured to
surround a portion of the elongated cutting instrument when the
elongated cutting instrument is inserted into said irrigation
sleeve; [0151] a tube aperture in an interior surface of said
second lumen, said tube aperture positioned at an intermediate
point along said second lumen between a proximal end and a distal
end of said sleeve body such that said tube aperture is facing
toward said second lumen to provide irrigation fluid to a surgical
site and to cool the elongated cutting instrument; [0152] an
irrigation conduit running adjacent to said second lumen, said
irrigation conduit configured to extend from said irrigation inlet
fitting of said sleeve body to said tube aperture to create a fluid
passageway for communicating irrigation fluid to the elongated
cutting instrument; [0153] wherein said irrigation outlet fitting
on said housing is configured to engage the irrigation inlet
fitting on said irrigation sleeve when said irrigation sleeve is
coupled to said housing such that the irrigation fluid flows
entirely within the ultrasonic handpiece and said hub; and
[0154] wherein said first end of said horn is operatively coupled
to said transducer such that said first conduit of said transducer
and said second conduit of said horn define a continuous passageway
extending from said proximal end to said distal end of said
housing.
xxvi. The ultrasonic handpiece assembly of clause xxv, wherein said
ultrasonic handpiece further comprises an irrigation inlet fitting
located on the proximal end of the housing and is configured to
receive irrigation fluid from an irrigation source. xxvii. The
ultrasonic handpiece assembly of clause xxv or xxvi, wherein said
threaded coupler is configured to removably couple said horn to the
elongated cutting instrument such that said continuous passageway
extending from said proximal end to said distal end of said housing
is in fluid communication with the aspiration lumen of the
elongated cutting instrument to allow for removal of ablated tissue
through the aspiration lumen when a vacuum is applied to said
continuous passageway. xxviii. The ultrasonic handpiece assembly of
any of clauses xxv-xxvii, wherein said hub further comprises:
[0155] a proximal portion and a distal portion, said proximal
portion having a first face configured to abut the ultrasonic
handpiece and a second face positioned distally of said first
face;
[0156] at least one retention finger protruding proximally from
said first face, said retention finger configured to engage the
housing of the ultrasonic handpiece;
[0157] a cavity defined in said proximal portion of said hub, said
cavity comprising an opening in a first surface; and
[0158] a sleeve transceiver positioned within said cavity and
configured to communicate with a corresponding handpiece
transceiver.
xxix. The ultrasonic handpiece assembly of clause xxviii, wherein
said housing further comprises:
[0159] an attachment region formed in said distal end of said
housing, said attachment region defining a recess comprising a
third face and a plurality of side walls configured to receive said
hub of said irrigation sleeve;
[0160] an attachment element in said third face of said recess,
said attachment element configured to receive said retention finger
of said irrigation sleeve to removably couple said irrigation
sleeve to said ultrasonic handpiece;
[0161] wherein said irrigation outlet fitting is configured to
extend from said third face of said recess to removably couple with
said irrigation sleeve to provide irrigation fluid to said
irrigation sleeve; and
[0162] wherein said second end of said horn is configured to
protrude from said face.
xxx. The ultrasonic handpiece assembly of any of clauses xxv-xxix,
wherein said irrigation sleeve further comprises a seal positioned
within said second lumen and configured to abut said interior
surface of said second lumen to space the elongated cutting
instrument from said interior surface of said second lumen. xxxi.
An ultrasonic handpiece assembly for use with an elongated cutting
instrument, said assembly comprising:
[0163] an ultrasonic handpiece comprising: [0164] a housing
comprising a proximal end and an opposing distal end, said housing
defining a volume, said distal end having a distal face; [0165] a
transducer configured to define a first conduit, said transducer at
least partially disposed within said volume defined by said
housing; [0166] a horn comprising a first end and an opposing
second end, said horn configured to be at least partially disposed
within said volume defined by said housing; [0167] a second conduit
in said horn configured to extend between said first end and said
second end of said horn; [0168] an irrigation outlet fitting
extending from said distal end of said housing and configured to
discharge irrigation fluid from said housing; [0169] a threaded
coupler on said second end of said horn configured to engage the
elongated cutting instrument; [0170] a recess in said distal end of
said housing, said recess comprising a recessed face and a
plurality of side walls configured to define an asymmetrical shape;
and [0171] a handpiece transceiver comprising a handpiece coil
comprising a first axis, said handpiece transceiver positioned
within one of said plurality of side walls;
[0172] an irrigation sleeve comprising: [0173] a hub comprising a
proximal portion and a distal portion, said proximal portion
configured to define an asymmetrical protrusion extending
proximally from said distal portion and sized to be inserted within
said recess of said housing; [0174] an abutment portion configured
to contact said distal face of said ultrasonic handpiece when said
asymmetrical protrusion is inserted in said recess of said housing,
said asymmetrical protrusion configured to ensure proper alignment
of said irrigation sleeve with said housing; [0175] a sleeve
transceiver comprising a sleeve coil and a memory unit, the memory
unit for storing information pertaining to the optimal driving
parameter for the elongated cutting instrument, said sleeve coil
having a second axis; and [0176] wherein said sleeve transceiver is
located in a cavity defined in said asymmetrical protrusion of said
hub such that second axis of said sleeve coil is oriented in
parallel to said first axis of said handpiece coil. xxxii. The
ultrasonic handpiece assembly of clause xxxi, wherein said
irrigation sleeve further comprises a sleeve body extending
distally from said distal portion of said hub, said sleeve body
defining a second lumen configured to surround a portion of the
elongated cutting instrument when the elongated cutting instrument
is inserted into said irrigation sleeve; and
[0177] a tube aperture in an interior surface of said second lumen,
said tube aperture positioned at an intermediate point along said
second lumen between a proximal end and a distal end of said sleeve
body such that said tube aperture is facing toward said second
lumen to provide irrigation fluid to a surgical site and to cool
the elongated cutting instrument.
xxxiii. The ultrasonic handpiece assembly of clause xxxii, wherein
said irrigation sleeve further comprises a seal positioned within
said second lumen and configured to abut said interior surface of
said second lumen to space the elongated cutting instrument from
said irrigation sleeve. xxxiv. The ultrasonic handpiece assembly of
clause xxxiii, wherein said asymmetrical protrusion further
comprises at least one retention finger protruding proximally from
said asymmetrical protrusion;
[0178] wherein said at least one retention finger and said seal
cooperate to ensure said irrigation sleeve is appropriately spaced
from the elongated cutting instrument when said ultrasonic
handpiece is coupled to said irrigation sleeve.
xxxv. The ultrasonic handpiece assembly of any of clauses
xxxi-xxxiv, further comprising an elongated cutting instrument
having a second threaded coupler at a proximal end and a distal end
comprising a cutting surface, said second threaded coupler of the
elongated cutting instrument configured to removably couple to said
threaded coupler of said horn. xxxvi. A method of assembling an
ultrasonic surgical handpiece without using separate irrigation
connections to a tip sleeve, said method comprising:
[0179] providing a housing including an irrigation conduit
configured to communicate irrigation fluid through the ultrasonic
surgical handpiece and an attachment region in a distal end of the
housing, the attachment region comprising: [0180] a recessed face
and a plurality of side walls configured to define an asymmetrical
void; and [0181] an attachment element in the attachment
region;
[0182] providing an irrigation sleeve comprising a hub including a
proximal portion and a distal portion, the proximal portion
comprising one or more retention fingers and configured to define
an asymmetrical protrusion extending proximally from the distal
portion and sized to be inserted within the recess of the housing;
and
[0183] coupling the housing to the irrigation sleeve by inserting
the asymmetrical protrusion into the asymmetrical void to engage
the one or more retention fingers with the attachment element to
provide irrigation fluid to the irrigation sleeve without
separately connecting an irrigation line to the irrigation
sleeve.
xxxvii. The method of clause xxxvi, further comprising the step of
providing a cutting tip, the cutting tip comprising a threaded
coupler at a distal end configured to removably secure the cutting
tip to the housing and a cutting element at a proximal end; and
[0184] coupling the cutting tip to the housing prior to the step of
coupling the housing to the irrigation sleeve.
xxxviii. The method of clause xxxvi or xxxvii, wherein the step of
coupling the housing to the irrigation sleeve further comprises
inserting a first irrigation fitting on a distal end of the
irrigation conduit of the housing into a corresponding second
irrigation fitting on the irrigation sleeve as the asymmetrical
protrusion is inserted into the asymmetrical void, wherein the
second irrigation fitting is in fluid communication with a second
conduit of the sleeve configured to provide irrigation fluid to a
cutting tip. xxxix. A tubing connector for integrally connecting an
irrigation line, an aspiration line, and a conductor to a proximal
portion of an ultrasonic surgical handpiece wherein the ultrasonic
surgical handpiece comprises an irrigation fitting and an
aspiration fitting that extend proximally from the proximal portion
of the handpiece, said tubing connector comprising:
[0185] a base comprising a distal end and a proximal end;
[0186] a first lumen in said base configured to create a fluid
passageway through said base that extends from said distal end to
said proximal end of said base, a said first lumen is configured to
receive the aspiration line proximate said proximal end of said
base;
[0187] wherein said base defines a groove in a perimeter of said
base that extends between said proximal end to said distal end of
said base, said groove configured to receive the conductor;
[0188] wherein a portion of said first lumen proximate said distal
end of said base is configured to removably couple with the
aspiration fitting the ultrasonic surgical handpiece via a friction
fit; and
[0189] wherein said tubing connector is configured to reduce strain
of the irrigation line and the aspiration line when coupled to the
surgical handpiece.
xl. The tubing connector of clause xxxix, wherein said base further
comprises:
[0190] a second lumen in said base, said second lumen configured to
create a second fluid passageway through said base that extends
from said distal end to said proximal end of said base, a said
second lumen is configured to receive the irrigation line proximate
said proximal end of said base;
[0191] wherein a portion of said second lumen proximate said distal
end of said base is configured to removably couple with the
irrigation fitting the ultrasonic surgical handpiece via a friction
fit.
xli. The tubing connector of clause 31, wherein said base further
comprises a resilient member extending proximally from said
proximal end of said base, said resilient member configured to
define a portion of said first lumen;
[0192] wherein said resilient member is configured to extend
proximally from said base to proximally offset the position the
aspiration line couples to said first lumen relative to the
position the irrigation line couples to said second lumen.
xlii. The tubing connector of clause xxxix or xl, wherein said base
further comprises a resilient member extending proximally from said
proximal end of said base, said resilient member configured to
define a portion of said first lumen. xliii. The tubing connector
of clause xxxix or xl, wherein said base further comprises a
resilient member extending proximally from said proximal end of
said base, said resilient member configured to define a portion of
said first lumen; and
[0193] wherein said resilient member is constructed from a
resilient material configured to support the aspiration line when
coupled to said tubing connector.
xliv. A tubing connector for integrally connecting an irrigation
line, an aspiration line, and a conductor to a proximal portion of
an ultrasonic surgical handpiece, said tubing connector
comprising:
[0194] a base comprising a proximal region and a distal region,
said base constructed of a resilient material;
[0195] a first lumen through said base that extends from said
proximal end to said distal end configured to create a first fluid
pathway to the proximal portion of the surgical handpiece, said
first lumen comprising a first coupler proximate said proximal end
of said base configured to receive the irrigation line;
[0196] a second lumen through said base that extends from said
proximal end to said distal end configured to create a second fluid
pathway to the proximal portion of the surgical handpiece, said
second lumen comprising a second coupler proximate said proximal
end of said base configured to receive the aspiration line;
[0197] wherein said base defines a groove in an outer perimeter of
said base that extends between said proximal region to said distal
region of said base, said groove configured to receive the
conductor; and
[0198] wherein said tubing connector is configured to reduce strain
of the aspiration line and the irrigation line when connected to
the surgical handpiece.
xlv. The tubing connector of clause xliv, wherein said base further
comprises a resilient member extending proximally from said
proximal region of said base, said resilient member configured to
define a portion of said first lumen. xlvi. An ultrasonic surgical
handpiece comprising:
[0199] a housing defining a cavity, said housing defining a
proximal aperture and a distal aperture;
[0200] a transducer comprising a distal end and a proximal end
disposed within said cavity of said housing, said transducer
configured to expand and contract along a longitudinal axis of the
transducer;
[0201] a tube defining a transducer lumen comprising a distal
portion and a proximal portion, said lumen being configured to
extend from said proximal end to said distal end of said transducer
and be oriented to be generally parallel to said longitudinal
axis;
[0202] a barrier member having a shell portion wholly within said
cavity and a channel portion that extends proximally from said
shell portion and extends through said proximal aperture, the shell
portion defining a shell lumen configured to encase said transducer
positioned within said housing, the channel portion configured to
rout aspirated fluid from said transducer lumen to a suction
line;
[0203] a horn at least partially disposed within said housing, said
horn coupled to said distal end of said transducer, said horn
defining a horn lumen that is in fluid communication with said
transducer lumen when said horn is coupled to said transducer;
[0204] a rear seal positioned between said proximal end of said
transducer and an interior surface of said cavity, said rear seal
configured to abut said proximal end of said transducer and define
a first aperture that engages an exterior surface of said tube and
an interior surface of said barrier member, said rear seal is
positioned between said shell portion and said channel portion of
said barrier member such that fluid cannot enter said shell portion
of said barrier member;
[0205] a front seal positioned disposed radially about an exterior
surface of said horn, said front seal;
[0206] a potting seal positioned between said transducer and a
distal end of said shell portion of said barrier member, said
potting seal configured to abut said distal end of said transducer
and define a second aperture for receiving said coupling feature of
said horn;
[0207] wherein said rear seal is configured to prevent moisture
ingress into said cavity proximate the proximal end of said
transducer; and
[0208] wherein said potting seal is configured to prevent moisture
ingress into said cavity proximate said distal end of said
transducer.
xlvii. The ultrasonic surgical handpiece of clause xlvi, wherein
said front seal comprises a plurality of bumps configured to
prevent ingress of moisture into said cavity between said horn and
said housing. xlviii. The ultrasonic surgical handpiece of clause
xlvi or xlvii, wherein said potting seal is configured to prevent
potting from entering said cavity. xlix. The ultrasonic surgical
handpiece of any of clauses xlvi-xlviii, wherein said rear seal and
said potting seal comprise a resilient material configured to
support said transducer within said cavity as said transducer
expands and contracts.
[0209] Several embodiments have been discussed in the foregoing
description. However, the embodiments discussed herein are not
intended to be exhaustive or limit the invention to any particular
form. For example, while the example configurations describe the
surgical instrument as an ultrasonic handpiece, it is further
contemplated that the features and concepts described with regard
to the ultrasonic handpiece may be applied to other medical or
surgical instruments. This similarly applies to the ultrasonic tip
20, which may further include blades, drill bits, rotating burs,
open-window shavers, and the like. The terminology which has been
used is intended to be in the nature of words of description rather
than of limitation. Many modifications and variations are possible
in light of the above teachings and the invention may be practiced
otherwise than as specifically described.
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