U.S. patent application number 11/726621 was filed with the patent office on 2008-09-25 for ultrasonic surgical instrument and cartilage and bone shaping blades therefor.
Invention is credited to Kevin L. Houser.
Application Number | 20080234709 11/726621 |
Document ID | / |
Family ID | 39775494 |
Filed Date | 2008-09-25 |
United States Patent
Application |
20080234709 |
Kind Code |
A1 |
Houser; Kevin L. |
September 25, 2008 |
Ultrasonic surgical instrument and cartilage and bone shaping
blades therefor
Abstract
An ultrasonic surgical blade that includes a blade body that has
a treatment region. At least one indentation can be formed in the
treatment region of the blade body wherein each indentation forms a
tissue cutting edge with an outer surface of the blade body. The
indentation may comprise one or more holes, lumens, grooves or
dimples or a combination of such structures. In various
embodiments, one or more aspiration lumens are provided in the
surgical blade which may ultimately communicate with an aspiration
lumen or passage in an ultrasonic surgical instrument.
Inventors: |
Houser; Kevin L.;
(Springboro, OH) |
Correspondence
Address: |
K&L GATES LLP
535 SMITHFIELD STREET
PITTSBURGH
PA
15222
US
|
Family ID: |
39775494 |
Appl. No.: |
11/726621 |
Filed: |
March 22, 2007 |
Current U.S.
Class: |
606/169 |
Current CPC
Class: |
A61B 2017/320069
20170801; A61B 2017/320089 20170801; A61B 2017/320071 20170801;
A61B 2017/320008 20130101; A61B 17/320068 20130101; A61B 2017/32008
20130101; A61B 2017/320084 20130101; A61B 2017/1602 20130101; A61B
2017/22079 20130101; A61B 2017/320073 20170801; A61B 2017/32007
20170801; A61B 2217/005 20130101; A61B 2017/320078 20170801 |
Class at
Publication: |
606/169 |
International
Class: |
A61B 17/32 20060101
A61B017/32 |
Claims
1. An ultrasonic surgical blade comprising: a blade body having an
treatment region; and at least one indentation formed in said
treatment region of said blade body wherein each said indentation
forms a tissue cutting edge with an outer surface of said blade
body.
2. An ultrasonic surgical blade according to claim 1 wherein said
at least one indentation is selected from the group consisting of
holes, lumens, grooves, and dimples.
3. An ultrasonic surgical blade according to claim 2 wherein said
grooves comprise a series of groove segments.
4. An ultrasonic surgical blade according to claim 1 wherein said
treatment region is substantially spherically-shaped.
5. An ultrasonic surgical blade according to claim 1 wherein said
at least one indentation comprises a hole that has a tapered
portion that forms said tissue cutting edge with said outer surface
of said blade body.
6. An ultrasonic surgical blade according to claim 5 wherein said
blade body is fabricated from a first material and wherein said
tapered portion is fabricated from a second material that differs
from said first material.
7. An ultrasonic surgical blade according to claim 1 wherein said
at least one indentation comprises a lumen extending through said
blade body, said lumen forming an opening through an outer surface
of said blade body such that a perimeter of said opening forms said
tissue cutting edge.
8. An ultrasonic surgical blade according to claim 1 wherein said
at least one indentation comprises a lumen extending through said
blade body, said lumen having a tapered distal end that forms an
opening in said treatment region that forms said tissue cutting
edge with said outer surface of said blade body.
9. An ultrasonic surgical blade according to claim 1 further
comprising: a neck portion protruding from a portion of said
treatment region along a longitudinal axis; a first lumen extending
through a portion of said blade body and said neck portion; and at
least one second lumen extending through another portion of said
blade body and intersecting said first lumen for fluid
communication therewith, each said second lumen forming at least
one opening through an outer surface of said blade body, each said
opening forming a tissue cutting edge with said outer surface.
10. An ultrasonic surgical blade according to claim 9 wherein said
at least one second lumen forms diametrically opposed openings
through said outer surface of said blade body.
11. An ultrasonic surgical blade according to claim 9 wherein said
at least one indentation comprises at least one groove in said
outer surface of said blade body and wherein said groove
communicates with at least one said opening.
12. An ultrasonic surgical blade according to claim 9 wherein said
at least one second lumen extends along an axis that is
substantially perpendicular to said longitudinal axis.
13. An ultrasonic surgical blade according to claim 1 wherein said
at least one indentation comprises at least one lumen formed in
said blade body and forming at least one opening through an outer
surface of said blade body such that a perimeter of said opening
forms said tissue cutting edge, said at least one lumen forming a
primary imbalance in said blade body.
14. An ultrasonic blade according to claim 13 further comprising a
second imbalance formed in said blade body offsetting said primary
imbalance.
15. An ultrasonic surgical blade according to claim 7 further
comprising an aspiration member communicating with said at least
one lumen.
16. An ultrasonic surgical blade according to claim 7 wherein said
at least one lumen is in fluid communication with at least one of
an aspiration module and an irrigation module.
17. A method for processing an ultrasonic surgical blade for
surgery, the method comprising: obtaining the ultrasonic surgical
blade of claim 1; sterilizing the ultrasonic surgical blade; and
storing the ultrasonic surgical blade in a sterile container.
18. An ultrasonic surgical blade comprising: a blade body having a
substantially spherically-shaped treatment region; and at least one
substantially sharp edge formed on at least a portion of said
spherically-shaped treatment region.
19. An ultrasonic surgical blade according to claim 18 wherein said
at least one substantially sharp edge comprises at least one
endless sharp edge formed by a groove in said substantially
spherically-shaped treatment region.
20. An ultrasonic surgical blade according to claim 18 further
comprising at least one lumen passage in said blade body.
21. An ultrasonic surgical blade according to claim 20 wherein said
at least one lumen passage forms an imbalance in said blade
body.
22. An ultrasonic surgical blade according to claim 21 further
comprising an aspiration member communicating with said at least
one lumen passage.
23. An ultrasonic surgical blade according to claim 22 wherein said
at least one lumen passage is in fluid communication with at least
one of an aspiration module and an irrigation module.
24. An ultrasonic surgical blade according to claim 21 wherein said
at least one lumen passage opens into said groove.
25. An ultrasonic surgical blade according to claim 18 further
comprising at least one lumen passage in said substantially
spherically-shaped treatment region and wherein said at least one
substantially sharp edge is formed wherein a tapered portion of
said lumen passage opens through a distal end of said substantially
spherically-shaped treatment region.
26. An ultrasonic surgical blade according to claim 18 further
comprising at least one hole in said substantially spherically
shaped treatment region wherein said at least one substantially
sharp edge is formed by a tapered portion of said hole that opens
through an outer surface of said substantially spherically-shaped
treatment region.
27. An ultrasonic surgical instrument comprising: an ultrasonic
transmission member having a proximal end and a distal end; and an
ultrasonically actuated blade attached to the distal end of the
ultrasonic transmission member, wherein the blade comprises: a
blade body having an treatment region; and at least one indentation
formed in said treatment region of said blade body wherein each
said indentation forms a tissue cutting edge with an outer surface
of said blade body.
28. An ultrasonic surgical instrument according to claim 27 wherein
said at least one indentation is selected from the group consisting
of holes, lumens, grooves, and dimples.
29. An ultrasonic surgical instrument according to claim 27 wherein
said treatment region is substantially spherically-shaped.
30. An ultrasonic surgical instrument according to claim 27 wherein
said ultrasonic transmission member is configured to transmit at
least one of a longitudinal motion, transverse motion and torsional
motion from a corresponding source of said longitudinal motion,
transverse motion, and torsional motion communicating therewith to
said ultrasonically actuated blade.
31. The ultrasonic surgical instrument according to claim 30
wherein said ultrasonic transmission member is configured to
transmit a combination of said longitudinal motion, transverse
motion and torsional motion to said ultrasonically actuated
blade.
32. A method for processing an ultrasonic surgical instrument, the
method comprising: obtaining the ultrasonic surgical instrument of
claim 27; detaching the ultrasonically actuated blade from the
distal end of the ultrasonic transmission member of the ultrasonic
surgical instrument; and performing one of the following actions:
reforming at least one of the indentations in the blade body,
resterilizing the ultrasonically actuated blade and reattaching the
resterilized blade to the distal end of the ultrasonic transmission
member; or attaching another sterilized ultrasonically actuated
blade to the distal end of the ultrasonic surgical instrument.
33. A method of mounting an ultrasonic surgical blade according to
claim 1 onto a distal end of an ultrasonic transmission member,
said method comprising one of the actions selected from the group
of actions consisting of welding, threading and gluing.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is related to the following
commonly-owned U.S. patent applications filed concurrently
herewith, and which are hereby incorporated by reference in their
entirety: [0002] (1) U.S. patent application Ser. No. ______,
entitled SURGICAL INSTRUMENTS, Attny. Docket No.
060877/END6050USNP; [0003] (2) U.S. patent application Ser. No.
______, entitled ULTRASONIC SURGICAL INSTRUMENTS, Atty. Docket No.
060878/END6051USNP; and [0004] (3) U.S. patent application Ser. No.
______, entitled SURGICAL INSTRUMENTS, Atty. Docket No.
060879/END6052USNP.
FIELD OF THE INVENTION
[0005] The present invention relates, in general, to ultrasonic
surgical instruments and, more particularly, to ultrasonic surgical
instruments and blades configured for removing bone and/or shaping
cartilage.
BACKGROUND OF THE INVENTION
[0006] During various orthopedic surgical procedures, it is often
necessary to remove small layers of cortical bone. Several
different tools have been developed to accomplish this task and for
preparing and/or shaping bone surfaces. For example, mallets are
often used to apply an impacting force on a medical tool, such as a
chisel, to remove pieces of bone. While mallets are somewhat
effective, the impacting force must be carefully applied to avoid
removal of too much bone or the inadvertent removal of a wrong
piece of bone. Moreover, the force applied to the chisel must be
applied in a sufficiently accurate manner to avoid damage to
adjacent tissues and/organs.
[0007] Other surgical tools known as burrs have also been developed
for removing layers of cortical bone and shaping bone and
cartilage. Such devices, however, generally must be employed with
high levels of precision to ensure that only the desired amount of
bone is removed and the surrounding tissues are not undesirably
damaged or traumatized. These burrs and similar instruments,
however, do not provide a means for controlling bleeding and tend
to leave the treated tissue with a roughened surface. In an effort
to address those problems, radio frequency-based devices were
developed.
[0008] Radio frequency-based devices enable surgeons to remove,
modulate, or sculpt soft tissue while simultaneously sealing blood
vessels. They work particularly well on connective tissue, which is
primarily comprised of collagen and which contracts when contacted
by heat. However, such radio frequency-based devices can create
undesirable deep thermal injury in the tissue.
[0009] Other instruments that have been developed for effectively
cutting and coagulating organic tissue employ mechanical vibrations
that are transmitted to a surgical end-effector at ultrasonic
frequencies. Ultrasonic vibrations, when transmitted to organic
tissue at suitable energy levels and using a suitable end-effector,
may be used to cut, dissect, elevate or cauterize tissue or to
separate muscle tissue off bone. Ultrasonic instruments utilizing
solid core technology are particularly advantageous because of the
amount of ultrasonic energy that may be transmitted from the
ultrasonic transducer, through a waveguide, to the surgical
end-effector.
[0010] Activating or exciting the end-effector (e.g., cutting
blade) of such instruments at ultrasonic frequencies induces
longitudinal vibratory movement that generates localized heat
within adjacent tissue, facilitating both cutting and coagulation.
Because of the nature of ultrasonic instruments, a particular
ultrasonically actuated end-effector may be designed to perform
numerous functions, including, for example, cutting and
coagulation.
[0011] Ultrasonic vibration is induced in the surgical end effector
by electrically exciting a transducer, for example. The transducer
may be constructed of one or more piezoelectric or magnetostrictive
elements in the instrument hand piece. Vibrations generated by the
transducer section are transmitted to the surgical end-effector via
an ultrasonic waveguide extending from the transducer section to
the surgical end-effector. The waveguides and end-effectors are
designed to resonate at the same frequency as the transducer.
Therefore, when an end-effector is attached to a transducer the
overall system frequency is the same frequency as the transducer
itself. Nevertheless, those skilled in the art will appreciate that
the system may be designed where the transducer and the blade
resonate at different frequencies and when joined the system
resonates at a desired frequency.
[0012] The amplitude of the longitudinal ultrasonic vibration at
the tip, d, of the end-effector behaves as a simple sinusoid at the
resonant frequency as given by:
d=A sin(.omega.t)
where: [0013] .omega.=the radian frequency which equals 2.pi. times
the cyclic frequency, f; and [0014] A=the zero-to-peak amplitude.
The longitudinal excursion is defined as the peak-to-peak (p-t-p)
amplitude, which is just twice the amplitude of the sine wave or
2A.
[0015] Over the years, a variety of different ultrasonic blade
configurations have been developed. Blades that tend to work well
from a coagulation standpoint (and hence change tissue into a
sticky coagulum that can be readily reshaped) do not tend to cut
extremely well. Some of those blades generally have
spherically-shaped body with a substantially smooth outer surface.
FIGS. 2 and 3 depict a spherically-shaped blade 10 of this type
that has been used in the past. Such blade design, while effective
from a coagulation standpoint, is not particularly well-suited for
bone removal or tissue reshaping applications due to its shape.
Other existing blades that are better adapted for cutting tissue,
are not as well-suited to coagulate and reshape tissue. These
problems can be further exacerbated in arthroscopic procedures that
afford limited access to the target tissue or bone and where the
blade must work in an aqueous environment.
[0016] It would, therefore, be advantageous to design a harmonic
surgical instrument for shaping either soft tissues such as
cartilage or meniscus or for decorticating bone. It would be
further advantageous to design a harmonic surgical instrument that
can be used to decorticate and aspirate bone and also facilitate
spot coagulation of tissue as well as tissue reshaping. Various
embodiments of the present invention incorporate improvements to
known ultrasonic instruments to provide these advantages. The
foregoing discussion is intended only to illustrate some of the
shortcomings present in the field of the invention at the time, and
should not be taken as a disavowal of claim scope.
SUMMARY
[0017] In one aspect of the invention, there is provided a surgical
instrument that comprises an ultrasonic surgical blade that
includes a blade body that has a treatment region. In various
embodiments, at least one indentation is formed in the treatment
region of the blade body wherein each indentation forms a tissue
cutting edge with an outer surface of the blade body.
[0018] In another general aspect of various embodiments of the
present invention there is provided an ultrasonic surgical blade.
In various embodiments, the blade has a blade body that includes a
substantially spherically-shaped treatment region. At least one
substantially sharp edge can be formed on at least a portion of the
spherically-shaped treatment region.
[0019] In still another general aspect of various embodiments of
the present invention there is provided an ultrasonic surgical
instrument comprising an ultrasonic transmission member that has a
proximal end and a distal end and an ultrasonically actuated blade
that is attached to the distal end of the transmission member. In
various embodiments, the blade has a blade body that has a
treatment region. At least one indentation can be formed in the
treatment region of the blade body. Each indentation may form a
tissue cutting edge with an outer surface of the blade body.
[0020] These and other objects and advantages of the present
invention shall be made apparent from the accompanying drawings and
the description thereof.
BRIEF DESCRIPTION OF THE FIGURES
[0021] The novel features of the various embodiments of the
invention are set forth with particularity in the appended claims.
The various embodiments of the invention, however, both as to
organization and methods of operation, together with further
objects and advantages thereof, may best be understood by reference
to the following description, taken in conjunction with the
accompanying drawings in which:
[0022] FIG. 1 is a partial cross-sectional view of a surgical
instrument of various embodiments of the present invention;
[0023] FIG. 2 is a partial perspective view of a portion of a prior
ultrasonic surgical blade;
[0024] FIG. 3 is a elevational view of the distal end of the prior
blade depicted in FIG. 2;
[0025] FIG. 4 is a perspective view of a portion of an ultrasonic
surgical blade embodiment of the present invention;
[0026] FIG. 5 is an elevational view of a distal end of the
ultrasonic surgical blade of FIG. 4;
[0027] FIG. 6 is a cross-sectional view of the portion of the
ultrasonic blade depicted in FIGS. 4 and 5 taken along line 6-6 in
FIG. 5;
[0028] FIG. 7 is a perspective view of a portion of another
ultrasonic surgical blade embodiment of the present invention;
[0029] FIG. 8 is an elevational view of a distal end of the
ultrasonic surgical blade of FIG. 7;
[0030] FIG. 9 is a cross-sectional view of the portion of the
ultrasonic blade depicted in FIGS. 7 and 8 taken along line 9-9 in
FIG. 8;
[0031] FIG. 10 is a perspective view of a portion of another
ultrasonic surgical blade embodiment of the present invention;
[0032] FIG. 11 is an elevational view of a distal end of the
ultrasonic surgical blade of FIG. 10;
[0033] FIG. 12 is a cross-sectional view of the portion of the
ultrasonic blade depicted in FIGS. 10 and 11 taken along line 12-12
in FIG. 11;
[0034] FIG. 13 is a perspective view of a portion of another
ultrasonic surgical blade embodiment of the present invention;
[0035] FIG. 14 is an elevational view of a distal end of the
ultrasonic surgical blade of FIG. 13;
[0036] FIG. 15 is a cross-sectional view of the portion of the
ultrasonic blade depicted in FIGS. 13 and 14 taken along line 15-15
in FIG. 14;
[0037] FIG. 16 is a perspective view of a portion of another
ultrasonic surgical blade embodiment of the present invention;
[0038] FIG. 17 is a top view of the ultrasonic surgical blade of
FIG. 16;
[0039] FIG. 18 is a perspective view of a portion of another
ultrasonic surgical blade embodiment of the present invention;
[0040] FIG. 19 is an elevational view of a distal end of the
ultrasonic surgical blade of FIG. 18;
[0041] FIG. 20 is a cross-sectional view of the portion of the
ultrasonic blade depicted in FIGS. 18 and 19 taken along line 20-20
in FIG. 19;
[0042] FIG. 21 is a perspective view of a portion of another
ultrasonic surgical blade embodiment of the present invention;
[0043] FIG. 22 is a top view of the portion of the ultrasonic blade
of FIG. 21;
[0044] FIG. 23 is a top view of a portion of another ultrasonic
surgical blade embodiment of the present invention; and
[0045] FIG. 24 is an elevational view of a distal end of the
ultrasonic surgical blade of FIG. 23.
DETAILED DESCRIPTION
[0046] Before explaining the present invention in detail, it should
be noted that the invention is not limited in its application or
use to the details of construction and arrangement of parts
illustrated in the accompanying drawings and description. The
illustrative embodiments of the invention may be implemented or
incorporated in other embodiments, variations and modifications,
and may be practiced or carried out in various ways. For example,
the surgical instrument and blade configurations disclosed below
are illustrative only and not meant to limit the scope or
application of the invention. Furthermore, unless otherwise
indicated, the terms and expressions employed herein have been
chosen for the purpose of describing the illustrative embodiments
of the present invention for the convenience of the reader and are
not for the purpose of limiting the invention.
[0047] Various embodiments of the present invention relate, in
general, to ultrasonic surgical blades for use with ultrasonic
surgical instruments and, more particularly, to ultrasonic surgical
blades and instruments for improved bone and tissue removal,
aspiration, and coagulation features. A blade according to various
embodiments of the present invention may be of particular benefit
in orthopedic procedures wherein it is desirable to remove cortical
bode and/or tissue while controlling bleeding. A variety of
different blade configurations are disclosed which may be useful
for both open and laparoscopic applications.
[0048] Examples of ultrasonic surgical instruments are disclosed in
U.S. Pat. Nos. 5,322,055 and 5,954,736 and in combination with
ultrasonic blades and surgical instruments as, for example,
disclosed in U.S. Pat. Nos. 6,309,400 B2, 6,278,218B1, 6,283,981
B1, and 6,325,811 B1 all of which are incorporated in their
entirety by reference herein. These references disclose ultrasonic
surgical instrument design and blade designs where a longitudinal
anti-node of the blade is excited. Because of asymmetry or
asymmetries, these blades exhibit transverse and/or torsional
motion where the characteristic "wavelength" of this
non-longitudinal motion is less than that of the general
longitudinal motion of the blade and its extender portion.
Therefore, the wave shape of the non-longitudinal motion will
present nodal positions of transverse/torsional motion along the
tissue effector while the net motion of the active blade along its
tissue effector is non-zero (i.e. will have at least longitudinal
motion along the length extending from its distal end, an antinode
of longitudinal motion, to the first nodal position of longitudinal
motion that is proximal to the tissue effector portion). Those of
ordinary skill in the art will also appreciate that the combination
of transverse and/or torsional motions in combination with the
longitudinal motion could augment the cutting action. Certain
exemplary embodiments will now be described to provide an overall
understanding of the principles of the structure, function,
manufacture, and use of the devices and methods disclosed herein.
One or more examples of these embodiments are illustrated in the
accompanying drawings. Those of ordinary skill in the art will
understand that the devices and methods specifically described
herein and illustrated in the accompanying drawings are
non-limiting exemplary embodiments and that the scope of the
various embodiments of the present invention is defined solely by
the claims. The features illustrated or described in connection
with one exemplary embodiment may be combined with the features of
other embodiments. Such modifications and variations are intended
to be included within the scope of the present invention.
[0049] FIG. 1 illustrates ultrasonic system 10 comprising an
ultrasonic signal generator 12 with ultrasonic transducer 14, hand
piece housing 16, and blade 100 in accordance with the present
invention. The ultrasonic transducer 14, which is known as a
"Langevin stack", generally includes a transduction portion 18, a
first resonator or end-bell 20, and a second resonator or fore-bell
22, and ancillary components. The ultrasonic transducer 14 is
preferably an integral number of one-half system wavelengths
(n.lamda./2) in length as will be described in more detail later.
An acoustic assembly 24 includes the ultrasonic transducer 14,
mount 26, velocity transformer 28 and surface 30.
[0050] The distal end of end-bell 20 is connected to the proximal
end of transduction portion 18, and the proximal end of fore-bell
22 is connected to the distal end of transduction portion 18.
Fore-bell 22 and end-bell 20 have a length determined by a number
of variables, including the thickness of the transduction portion
18, the density and modulus of elasticity of the material used to
manufacture end-bell 20 and fore-bell 22, and the resonant
frequency of the ultrasonic transducer 14. The fore-bell 22 may be
tapered inwardly from its proximal end to its distal end to amplify
the ultrasonic vibration amplitude as velocity transformer 28, or
alternately may have no amplification.
[0051] The transducer may be constructed of one or more
piezoelectric or magnetostrictive elements in the instrument hand
piece. Ultrasonic vibration is induced in the surgical end-effector
by, for example, electrically exciting a transducer which may be
constructed of one or more piezoelectric or magnetostrictive
elements in the instrument hand-piece. Vibrations generated by the
transducer section are transmitted to the surgical end-effector via
an ultrasonic waveguide extending from the transducer section to
the surgical end-effector.
[0052] In the illustrated embodiment, the transducer is constructed
with piezoelectric elements 40. The piezoelectric elements 40 may
be fabricated from any suitable material, such as, for example,
lead zirconate-titanate, lead meta-niobate, lead titanate, or other
piezoelectric crystal material. Each of the positive electrodes 42,
negative electrodes 44, and piezoelectric elements 40 has a bore
extending through the center. The positive and negative electrodes
42 and 44 are electrically coupled to wires 46 and 48,
respectively. Wires 46 and 48 are encased within cable 50 and
electrically connectable to ultrasonic signal generator 12 of
ultrasonic system 10.
[0053] Ultrasonic transducer 14 of the acoustic assembly 24
converts the electrical signal from ultrasonic signal generator 12
into mechanical energy that results in primarily longitudinal
vibratory motion of the ultrasonic transducer 14 and blade 100 at
ultrasonic frequencies. A suitable generator is available as model
number GEN04, from Ethicon Endo-Surgery, Inc., Cincinnati, Ohio.
When the acoustic assembly 24 is energized, a vibratory motion
standing wave is generated through the acoustic assembly 24. The
amplitude of the vibratory motion at any point along the acoustic
assembly 24 may depend upon the location along the acoustic
assembly 24 at which the vibratory motion is measured. A minimum or
zero crossing in the vibratory motion standing wave is generally
referred to as a node (i.e., where motion is usually minimal), and
an absolute value maximum or peak in the standing wave is generally
referred to as an anti-node. The distance between an anti-node and
its nearest node is one-quarter wavelength (.lamda./4).
[0054] Wires 46 and 48 transmit the electrical signal from the
ultrasonic signal generator 12 to positive electrodes 42 and
negative electrodes 44. The piezoelectric elements 40 are energized
by an electrical signal supplied from the ultrasonic signal
generator 12 in response to a foot switch 60 to produce an acoustic
standing wave in the acoustic assembly 24. The electrical signal
causes disturbances in the piezoelectric elements 40 in the form of
repeated small displacements resulting in large compression forces
within the material. The repeated small displacements cause the
piezoelectric elements 40 to expand and contract in a continuous
manner along the axis of the voltage gradient, producing
longitudinal waves of ultrasonic energy. The ultrasonic energy is
transmitted through the acoustic assembly 24 to the blade 100.
[0055] In order for the acoustic assembly 24 to deliver energy to
the blade 100, all components of acoustic assembly 24 must be
acoustically coupled to the blade 100. The distal end of the
ultrasonic transducer 14 may be acoustically coupled at surface 30
to the proximal end of an ultrasonic waveguide 80 by a threaded
connection such as stud 90.
[0056] The components of the acoustic assembly 24 are preferably
acoustically tuned such that the length of any assembly is an
integral number of one-half wavelengths (n.lamda./2), where the
wavelength .lamda. is the wavelength of a pre-selected or operating
longitudinal vibration drive frequency f.sub.d of the acoustic
assembly 24, and where n is any positive integer. It is also
contemplated that the acoustic assembly 24 may incorporate any
suitable arrangement of acoustic elements.
[0057] In addition, an aspiration transducer may be provided, such
as a phaco-emulsifier, includes a central lumen in the transducer
to allow for aspiration of tissue and fluids through the back of
the transducer. The central lumen may be inserted through an
incision and vibrates ultrasonically to liquefy tissue. The
emulsified tissue is removed by aspiration via the lumen through
the back of the transducer. Modern aspirators also perform
irrigation. These irrigation/aspiration instruments have dual
passages or lumens, one for irrigation and the other for
aspiration. Usually the passages are coaxial, the inner passage
being formed by a rigid or semi-rigid cannula, and the outer
passage having a distal portion formed by a sleeve which may be
resilient. One or more components of the tips are removable from
the handpiece of the instrument for selection of an appropriate or
desired tip, and for replacement of the tip.
[0058] FIGS. 4-6 illustrate one ultrasonic surgical blade
embodiment of the present invention that may be employed with the
above-described ultrasonic instrument 10. However, as the present
detailed description proceeds, those of ordinary skill in the art
will understand that the various ultrasonic surgical blade
embodiments that are disclosed herein as well as any equivalent
structures thereof could conceivably be effectively used in
connection with other known ultrasonic surgical instruments without
departing from the spirit and scope of the present invention. Thus,
the protection afforded to the various ultrasonic surgical blade
embodiments disclosed herein should not be limited to use only in
connection with the exemplary ultrasonic surgical instrument
described above.
[0059] As can be seen in FIGS. 4-6, the ultrasonic surgical blade
100 has a blade body 110 that has a generally smooth exterior
surface 122 that is well-suited for coagulation and tissue
reshaping applications. The smooth exterior surface is well-suited
for coagulation of tissue due to the ability to place a large blunt
surface that is ultrasonically active against the tissue. This
allows for the transfer of heat without the risk of cutting,
allowing the tissue to form into a sticky coagulum that seals
vessels. The blade 100 may be fabricated from a material suitable
for transmission of ultrasonic energy such as, for example, Ti6Al4V
( an alloy of Titanium including Aluminum and Vanadium), Aluminum,
Stainless Steel, or other known materials. The blade body 110 may
comprise a substantially spherically-shaped treatment region,
generally designated as 120, and a neck or transition portion 130
that protrudes from a proximal portion 121 of the treatment region
120. As indicated above, the neck portion 130 may be attached to
the waveguide 80 by, for example, a stud, welding, gluing, or other
known methods. In alternative embodiments, the neck portion 130 and
waveguide 80 may comprise a single unit. The ultrasonic waveguide
80 may, for example, have a length substantially equal to an
integral number of one-half system wavelengths (.lamda./2). The
ultrasonic waveguide 80 may be preferably fabricated from a solid
core shaft constructed out of material that propagates ultrasonic
energy efficiently, such as titanium alloy (i.e., Ti-6Al-4V) or an
aluminum alloy, for example. The ultrasonic waveguide 80 may also
be configured to amplify the mechanical vibrations transmitted to
the ultrasonic blade 100 as is well known in the art.
[0060] In alternative embodiments the ultrasonic transmission
waveguide may be fabricated with a hollow core. In other
embodiments, the ultrasonic surgical blade may comprise an outer
sheath that protects patient tissues from the ultrasonic
transmission waveguide. In such embodiment, a lumen may be provided
in the longitudinal extending space between the outer sheath and
the surgical blade. The lumen may be employed to irrigate or
aspirate tissue trough through the lumen located between the blade
and the outer sheath.
[0061] The ultrasonic blade 100 may have a length substantially
equal to an integral multiple of one-half system wavelengths
(.lamda./2). The distal end of ultrasonic blade 100 is disposed
near an antinode in order to provide the maximum longitudinal
excursion of the distal end. When the transducer assembly is
energized, the distal end 124 of the ultrasonic blade 100 may be
configured to move in the range of, for example, approximately 10
to 150 microns peak-to-peak, and preferably in the range of about
30 to 150 100 microns at a predetermined vibrational frequency of
55.5 kHz. The ultrasonic blade 100 may be configured to vibrate
with an amplitude at a specified frequency that creates a blade
velocity of between 2 meters/sec and 30 meters/sec.
[0062] While the treatment region in this exemplary embodiment is
substantially spherical in shape, those of ordinary skill in the
art will appreciate that the blade body 110 may be provided in
other shapes that provide a substantially smooth and rounded outer
perimeter. For example, the blade body could comprise a slightly
elongated cylinder-like member with a rounded distal end.
[0063] Referring to FIG. 1, in various embodiments, an aspiration
lumen 140 may be provided through the treatment region 120 and neck
portion 130 and be configured to ultimately communicate with a
stand alone suction/irrigation module, tower mounted suction 90
and/or irrigation 92 modules (FIG. 1), or an integrated ultrasonic
generator/suction/irrigation module in the operating room, for
example. It may also be advantageous to integrate
suction/irrigation controls (i.e. trumpet valves, etc.) and a means
for selecting either suction or irrigation functions within the
device handle.
[0064] As can be seen in FIGS. 4 and 6, the aspiration lumen 140
can form an opening 150 in the distal end 124 of the treatment
region 120. In various embodiments, the opening 150 is defined by
an tissue cutting edge 152 formed in the outer surface 122 of the
treatment region 120. Cutting edge 152 can be used to cut and
reshape tissue and it may also serve as a bearing surface or edge
for removing cortical bone. As the tissue and/or bone material is
cut away or dislodged by cutting edge 152, the material can be
removed from the surgical field through the lumen 140 and the
aspiration passage in the surgical instrument. In at least one
embodiment, the spherically-shaped treatment region 110 and
relative smooth perimetrical outer surface 122 are well-suited for
coagulating and reshaping tissue. More particularly, owing to the
substantially spherically shaped surface 122, surface 122 can be
used to heat and manipulate tissue, for example, without cutting it
such that, when the tissue cools, the tissue can maintain its
reconfigured shape. The edge 152 may also provide the surgeon with
a means for cutting and shaping tissue and dislodging pieces of
bone which represents a vast improvement of prior
spherically-shaped ultrasonic blades. This embodiment also provides
the added feature of being able to aspirate the surgical field and
to remove tissue and small pieces of bone therefrom.
[0065] FIGS. 7-9 illustrate another ultrasonic surgical blade 200
of the present invention. As can be seen in those Figures, the
blade 200 has a blade body 210 that has a relative smooth outer
surface 222 and may be fabricated from any of the materials
described above. The blade body 210 may comprise a substantially
spherically-shaped treatment region, generally designated as 220
and a neck or transition portion 230 that protrudes from a proximal
portion 221 of the treatment region 220. The neck portion 230 may
be attached to a waveguide (not shown) by, for example, a stud,
welding, gluing, or other known methods. In alternative
embodiments, the neck portion 230 and waveguide may comprise a
single unit.
[0066] In various embodiments, an aspiration lumen 240 may be
provided through the treatment region 220 and neck portion 230 and
ultimately communicate with a stand alone suction/irrigation
module, tower mounted suction 90 and/or irrigation 92 modules (FIG.
1), or an integrated ultrasonic generator/suction/irrigation module
in the operating room, for example. Those of ordinary skill in the
art will understand that the suction module may be employed to
aspirate tissue and fluids away from the surgical site and the
irrigation module may be used to supply irrigation fluids to the
surgical site. In the present embodiment, the aspiration lumen 240
has a tapered portion 242 that forms an opening 250 in the distal
end 224 of the treatment region 220. The opening 250 is defined by
a tissue cutting edge 252 formed in the outer surface 222 of the
treatment region 220 that can be used to form and reshape tissue
and also assist in the removal of cortical bone. In various
embodiments, edge 252 may be relatively sharp to assist in the
removal of tissue and/or bone. As the tissue and/or bone material
is cut away or dislodged, it can be removed from the surgical field
through the aspiration lumen 240. One advantage of the tapered
portion is that it initially allows for an acute angle at the ball
surface, creating a much sharper edge than a straight bore. In
addition, the tapered portion 272 narrows the cutting hole to
minimize the size of the particles generated by cutting. This
increases the likelihood that the size of the particles is smaller
than the central lumen and thus minimizing the likelihood that they
will become stuck in the lumen.
[0067] In alternative embodiments, the tapered portion 272 may be
fabricated from a material that has a property or properties that
differ from the property/properties of the material from which the
blade body 210 is fabricated. For example, such tapered portion 272
may be pressed into the lumen 240 and/or otherwise attached in
position by welding, threads, or other suitable fastener
arrangements. In various embodiments, the second material may be
selected based on its tensile strength, fatigue strength and/or its
ability to maintain an edge or other desirable properties.
[0068] FIGS. 10-12 illustrate another ultrasonic surgical blade 300
of the present invention. As can be seen in those Figures, the
blade 300 has a blade body 310 that has a relatively smooth outer
surface 322 and may be fabricated from any of the materials
described above. The blade body 310 may comprise a substantially
spherically-shaped treatment region, generally designated as 320. A
neck or transition portion 330 protrudes from a proximal portion
321 of the treatment region 320. The neck portion 330 may be
attached to a waveguide (not shown) by, for example, a stud,
welding, gluing, or other known methods. In alternative
embodiments, the neck portion 330 and waveguide may comprise a
single unit.
[0069] In various embodiments, a first aspiration lumen 340 may be
provided in the treatment region 320 and neck portion 330 along a
longitudinal axis A-A which ultimately communicates with a stand
alone suction/irrigation module, tower mounted suction 90 and/or
irrigation 92 modules (FIG. 1), or an integrated ultrasonic
generator/suction/irrigation module in the operating room, for
example. In the present embodiment, the first aspiration lumen 340
intersects a second aspiration lumen 342 in the treatment region
320 that lies along an axis B-B that intersects axis A-A. In
various embodiments, axis B-B may be substantially perpendicular to
axis A-A as shown in FIGS. 10 and 12. The second aspiration lumen
342 may form two diametrically opposed openings 344, 346 in the
treatment region 320. In the present embodiment, opening 344 is
defined by an edge 345 and opening 346 is defined by an edge 347.
Edges 345, 347 can be used to form and reshape tissue and also
assist in the removal of cortical bone. In various embodiments, one
or both edges 345, 347 may be relatively sharp to assist in the
removal of tissue and/or bone. As the tissue and/or bone material
is cut away or dislodged by edges 345, 347, the material can be
removed from the surgical field through the lumens 340 and 342. In
alternative embodiments, one or both of openings 344, 346 may be
formed with a tapered portion of the arrangements described
above.
[0070] FIGS. 13-15 illustrate another ultrasonic surgical blade 400
of the present invention. As can be seen in those Figures, the
blade 400 has a blade body 410 that has a relatively smooth outer
surface 422 and may be fabricated from any of the materials
described above. The blade body 410 may comprise a substantially
spherically-shaped treatment region, generally designated as 420.
In this embodiment, an endless groove 450 is provided around the
circumference of the treatment region 420. The groove 450 may have
a rounded bottom as shown or it may have a pointed bottom, square
bottom, etc. In the illustrated embodiment, the circumferentially
extending endless groove 450 forms two parallel edges 452, 454 in
the otherwise substantially smooth outer surface 422 for cutting
and forming tissue and for providing a bearing surface to remove
bone and tissue. A neck or transition portion 430 can protrude from
a proximal portion 421 of the treatment region 420. The neck
portion 430 may be attached to a waveguide (not shown) by, for
example, a stud, welding, gluing, or other known methods. In
alternative embodiments, the neck portion 430 and waveguide may
comprise a single unit.
[0071] In various embodiments, an aspiration lumen 440 may be
provided in the treatment region 420 and neck portion 430 which
ultimately communicates with a stand alone suction/irrigation
module, tower mounted suction 90 and/or irrigation 92 modules (FIG.
1), or an integrated ultrasonic generator/suction/irrigation module
in the operating room, for example. In this embodiment, at least
one, but preferably two, cross lumens 442, 444 can extend from the
closed end 441 of lumen 440 in diametrically opposed directions and
open into the endless groove 450 as shown. As the tissue and/or
bone material is cut away or dislodged by edges 452, 454, the
material can be removed from the surgical field through the lumens
444, 442, and 440. In the embodiment depicted in FIGS. 13-15, one
endless groove 450 is shown. In the illustrated embodiment, the
groove extends around the circumference such that it is
substantially perpendicular to the neck. In other embodiments, one
or more grooves may be formed around body such that they are not
perpendicular to the neck portion--e.g., they extend vertically. In
alternative embodiments, a plurality of endless grooves may be
employed. In still other embodiments, a plurality of discrete
grooves may be provided in the relatively smooth outer surface 412.
Those discrete grooves may be arranged along substantially parallel
axes or they may be axially aligned along a single axis. Those of
ordinary skill in the art will also understand that one, two, or
more than two cross-lumens may be employed. Such cross lumens may
either open into a groove or the outer surface 422 and also open
into the aspiration lumen 430. In still other embodiments, one or
more cross-lumens may open into a groove and one or more other
cross-lumens may open through the surface 422. Those of ordinary
skill in the art will understand that, in those embodiments wherein
only one cross lumen is employed, such arrangement may result in an
imbalance in the blade that may also generate some desirable
transverse motions. In still other embodiments wherein only one
cross-lumen is employed, such "primary" imbalance caused by only a
single cross-lumen may be neutralized by a cavity or similar area
(a "secondary" imbalance) provided in another portion of the blade
or the cross-lumen could be made small enough to minimize any
imbalance created thereby. In other embodiments as shown in FIGS.
16 and 17, no lumens are provided in blade body 410.
[0072] FIGS. 18-20 illustrate another ultrasonic surgical blade 500
of the present invention. As can be seen in those Figures, the
blade 500 has a blade body 510 that has a relatively smooth outer
surface 522 and may be fabricated from any of the materials
described above. The blade body 510 may comprise a substantially
spherically-shaped treatment region, generally designated as 520.
In this embodiment, at least one discreet hole 550 is provided in
the treatment region 520. In the embodiment shown in FIGS. 18-20,
four holes 550 are shown. In various embodiments, the number and
arrangement of holes 550 may vary. Each hole 550 can form an
opening 552 in the treatment region 520 that forms a tissue cutting
edge 554 in the outer surface 422 that can be used to form and
reshape tissue and also assist in the removal of cortical bone. The
holes 550 may have a flat bottom 555 as shown or the bottoms may be
rounded, pointed, etc. One or more of the holes 550 may have a
tapered portion 551 to further facilitate formation of a sharpened
edge 554. In the illustrated embodiment, a neck or transition
portion 430 can protrude from a proximal portion 521 of the
treatment region 520. The neck portion 530 may be attached to a
waveguide (not shown) by, for example, a stud, welding, gluing, or
other known methods. In alternative embodiments, the neck portion
430 and waveguide may comprise a single unit.
[0073] FIGS. 21 and 22 illustrate another ultrasonic surgical blade
600 of the present invention. As can be seen in those Figures, the
blade 600 has a blade body 610 that has a relatively smooth outer
surface 622 and may be fabricated from any of the materials
described above. The blade body 610 may comprise a substantially
spherically-shaped treatment region, generally designated as 620.
In this embodiment, at least one dimple 650 is provided in the
treatment region 620. In the embodiment shown in FIGS. 21 and 22,
four dimples 650 are shown. In various embodiments, the number and
arrangement of dimples 650 may vary. Each dimple 650 can form a
tissue cutting edge 652 in the exterior surface 622 that can be
used to form and reshape tissue and also assist in the removal of
cortical bone. In the illustrated embodiment, a neck or transition
portion 630 protrudes from a proximal portion of the treatment
region 620. The neck portion 630 may be attached to a waveguide
(not shown) by, for example, a stud, welding, gluing, or other
known methods. In alternative embodiments, the neck portion 630 and
waveguide may comprise a single unit.
[0074] FIGS. 23 and 24 illustrate another ultrasonic surgical blade
700 of the present invention. As can be seen in those Figures, the
blade 700 has a body 710 that has a rounded distal end 712 and two
relatively planar surfaces 714 and 716 that are separated by a side
surface 718. Blade 700 may be fabricated from any of the materials
described above. The body 710 may comprise a treatment region,
generally designated as 720. In this embodiment, at least one hole
750 is provided in the side 718 of the body 710. In the embodiment
shown in FIGS. 23 and 24, three holes 750 are shown. In various
embodiments, the number and arrangement of holes 750 may vary. Each
hole 750 can form an opening 752 in the body portion 710 that forms
an edge 754 that can be used to form and reshape tissue and also
assist in the removal of cortical bone. In one embodiment, the
holes 750 may be in fluid communication with a central lumen for
irrigation and aspiration of tissue during cutting. The holes 750
may have a flat bottom 755 as shown or the bottoms may be rounded,
pointed, etc. In the illustrated embodiment, a neck or transition
portion 730 protrudes from a proximal portion of the treatment
region 720. The neck portion 730 may be attached to a waveguide
(not shown) by, for example, a stud, welding, gluing, or other
known methods. In alternative embodiments, the neck portion 730 and
waveguide may comprise a single unit.
[0075] The various embodiments of the present invention described
herein, as well as their equivalent structures, represent a vast
improvement over prior ultrasonic surgical blade configurations.
For example, several of the embodiments disclosed herein include a
treatment region that is substantially spherical in shape and has a
relatively smooth outer surface which can be advantageously
employed to coagulate and reshape tissue. In addition, several of
the embodiments disclosed herein have one or more tissue cutting
edges formed in the treatment region thereof which can be used to
cut and shave tissue and may also serve as bearing surfaces that
can be used to engage and remove portions of cortical bone when an
impact force is applied to the instrument by conventional means
(mallet, etc.). These edges may be advantageously sharpened
utilizing files or other conventional sharpening tools or, if
desired, the edges may be relatively dull. A variety of different
structures have been disclosed for forming the edges in the
otherwise smooth exterior surface of the body portion. In general,
the edges may be formed by indentations in the outer surface of the
body portion. As used in this context, the term "indentation" may
comprise, for example, a discrete hole (i.e., a hole that does not
pass completely through any portion of the body), a lumen or
passageway that forms an opening in the outer surface and passes
through the body member, a groove or series of grooves formed in
the outer surface of the body portion, dimples and/or any
combination of these indentations. The number and orientations of
such "indentations" may vary without departing from the spirit and
scope of the present invention and provided that a desired amount
of relatively smooth surface is maintained for coagulation and
tissue shaping purposes.
[0076] Thus, as can be appreciated form the foregoing, various
embodiments of the present invention provide a faster and more
precise method for removing cortical bone. Such arrangements may
also require less force to remove bone than prior bone removal
methods. In addition, the unique and novel features of various
embodiments of the present invention also facilitate spot
coagulation of tissue with out the need to use radio
frequency-based means which can create deep thermal injury to the
tissue.
[0077] While several embodiments of the invention have been
described, it should be apparent, however, that various
modifications, alterations and adaptations to those embodiments may
occur to persons skilled in the art with the attainment of some or
all of the advantages of the invention. For example, according to
various embodiments, a single component may be replaced by multiple
components, and multiple components may be replaced by a single
component, to perform a given function or functions. This
application is therefore intended to cover all such modifications,
alterations and adaptations without departing from the scope and
spirit of the disclosed invention as defined by the appended
claims.
[0078] The blades and devices disclosed herein can be designed to
be disposed of after a single use, or they can be designed to be
used multiple times. In either case, however, the device may be
reconditioned for reuse after at least one use. Reconditioning can
include an combination of the steps of disassembly of the device,
followed by cleaning or replacement of particular pieces, and
subsequent reassembly. In particular, the device may be
disassembled, and any number of particular pieces or parts of the
device can be selectively replaced or removed in any combination.
Upon cleaning and/or replacement of particular parts, the device
may be reassembled for subsequent use either at a reconditioning
facility, or by a surgical team immediately prior to a surgical
procedure. Those of ordinary skill in the art will appreciate that
the reconditioning of a device may utilize a variety of different
techniques for disassembly, cleaning/replacement, and reassembly.
Use of such techniques, and the resulting reconditioned device, are
all within the scope of the present application.
[0079] Preferably, the invention described herein will be processed
before surgery. First a new or used instrument is obtained and, if
necessary, cleaned. The instrument can then be sterilized. In one
sterilization technique, the instrument is placed in a closed and
sealed container, such as a plastic or TYVEK.RTM. bag. The
container and instrument are then placed in a field of radiation
that can penetrate the container, such as gamma radiation, x-rays,
or higher energy electrons. The radiation kills bacteria on the
instrument and in the container. The sterilized instrument can then
be stored in the sterile container. The sealed container keeps the
instrument sterile until it is opened in the medical facility.
[0080] It is preferred that the device is sterilized. This can be
done by any number of ways known to those skilled in the art
including beta or gamma radiation, ethylene oxide, steam,
autoclaving, soaking in sterilization liquid, or other known
processes.
[0081] Any patent, publication, or other disclosure material, in
whole or in part, that is said to be incorporated by reference
herein is incorporated herein only to the extent that the
incorporated materials does not conflict with existing definitions,
statements, or other disclosure material set forth in this
disclosure. As such, and to the extent necessary, the disclosure as
explicitly set forth herein supersedes any conflicting material
incorporated herein by reference. Any material, or portion thereof,
that is said to be incorporated by reference herein, but which
conflicts with existing definitions, statements, or other
disclosure material set forth herein will only be incorporated to
the extent that no conflict arises between that incorporated
material and the existing disclosure material.
[0082] The invention which is intended to be protected is not to be
construed as limited to the particular embodiments disclosed. The
embodiments are therefore to be regarded as illustrative rather
than restrictive. Variations and changes may be made by others
without departing from the spirit of the present invention.
Accordingly, it is expressly intended that all such equivalents,
variations and changes which fall within the spirit and scope of
the present invention as defined in the claims be embraced
thereby.
* * * * *