U.S. patent application number 12/051073 was filed with the patent office on 2008-10-02 for interchangeable high intensity focused ultrasound transducer.
This patent application is currently assigned to LipoSonix, Inc.. Invention is credited to JEFFREY ROBERT CRUNKILTON.
Application Number | 20080243035 12/051073 |
Document ID | / |
Family ID | 39789258 |
Filed Date | 2008-10-02 |
United States Patent
Application |
20080243035 |
Kind Code |
A1 |
CRUNKILTON; JEFFREY ROBERT |
October 2, 2008 |
INTERCHANGEABLE HIGH INTENSITY FOCUSED ULTRASOUND TRANSDUCER
Abstract
An interchangeable transducer for use with an ultrasound medical
system having a keyless adaptor and capable of operating in a wet
environment. The interchangeable transducer has an adaptor for
engaging a medical system, an ultrasound transducer and additional
electronics to provide a self-contained insert for easy replacement
and usage in a variety of medical applications. A slip ring spacer
is also disclosed, the slip ring spacer for use with a pancake slip
ring having a base and flange configuration to form one or more
channels around each contact ring of the pancake slip ring. The
channels provide fluid isolation around each connector to help
reduce electronic cross talk and contact corrosion between the
connector pads of the slip ring while the slip ring is immersed in
a wet environment.
Inventors: |
CRUNKILTON; JEFFREY ROBERT;
(Everett, WA) |
Correspondence
Address: |
TOWNSEND AND TOWNSEND AND CREW LLP;LIPOSONIX, INC.
TWO EMABARCADERO CENTER, EIGHTH FLOOR
SAN FRANCISCO
CA
94111
US
|
Assignee: |
LipoSonix, Inc.
Bothell
WA
|
Family ID: |
39789258 |
Appl. No.: |
12/051073 |
Filed: |
March 19, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60908074 |
Mar 26, 2007 |
|
|
|
60976867 |
Oct 2, 2007 |
|
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Current U.S.
Class: |
601/2 |
Current CPC
Class: |
A61B 2017/0046 20130101;
A61N 7/02 20130101; A61B 2017/00477 20130101 |
Class at
Publication: |
601/2 |
International
Class: |
A61N 7/00 20060101
A61N007/00 |
Claims
1. An insert for use with a medical ultrasound system, the insert
comprising: a housing having an adaptor end and an acoustic end; a
communication port at said adaptor end, the adapter end having two
or more orientations for engagement to a receptacle in a medical
ultrasound system; a transducer at said acoustic end, said
transducer forming a fluid tight seal with said housing, and for at
least one electrical connector between said communication port and
said transducer.
2. The insert as described in claim 1, wherein said connection port
further comprises an isolation layer.
3. The insert of claim 2, wherein the isolation layer is a slip
ring spacer.
4. The insert as described in claim 1, wherein the adapter end has
radial freedom to engage a receptacle in any radial
orientation.
5. The insert as described in claim 1, wherein said electrical
contacts are spring loaded contract pins.
6. The insert as described in claim 1, wherein the transducer has
two or more discrete focal zones.
7. The insert as described in claim 1, wherein the transducer has
an imperfect focal region.
8. The insert as described in claim 1, wherein the adaptor end is
slidably engaged into said medical ultrasound system.
9. The insert as described in claim 1, wherein said electrical
connector comprises one or more electrical components.
10. The insert as described in claim 1, wherein the electrical
connector are a first set of spring pins frictionally engaged
between said communication port and a PCB, and a second set of
spring pins frictionally engaged between the PCB and the
transducer.
11. The insert as described in claim 1, wherein the insert is
disposable.
12. An interchangeable transducer apparatus adapted for use with a
high intensity focused ultrasound (HIFU) medical system, the
apparatus comprising: a substantially rigid and hollow housing
having an axial alignment and having a first end and a second end;
a transducer positioned within the first end of the housing, the
transducer being electrically connected to an interface disposed
within the housing and forming a fluid tight seal with the housing;
an isolation layer positioned within the second end of the housing,
the isolation layer having a plurality of apertures for receiving a
plurality electrical connectors extending from the interface; a
connector positioned on the exterior surface of the housing, the
connector allowing for the removable engagement of the housing with
an ultrasound medical system; wherein the connector and electrical
connectors provide releasable mechanical and electrical engagement
(respectively) to a receptacle in the medical system in two or more
axial alignments between the housing and the ultrasound medical
system.
13. The apparatus of claim 12, wherein said ultrasound medical
system is a high intensity focused ultrasound (HIFU) medical
system.
14. The apparatus of claim 12, wherein the isolation layer is a
slip ring spacer.
15. The apparatus of claim 14, wherein the slip ring spacer has a
plurality of concentric rings adapted to is isolate the electrical
connectors from one another.
16. The ultrasound medical system of claim 12, wherein the
receptacle is a wet environment.
17. The apparatus of claim 12, wherein the interface is a
circuit.
18. The circuit of claim 17, further comprising at least one
electronic control component for controlling the transducer.
19. The apparatus of claim 12, wherein the interface is a printed
circuit board or assembly (PCB or PCBA).
20. The apparatus of claim 12, wherein the electrical connectors
are spring loaded contact pins.
21. The apparatus of claim 12, wherein the transducer has two or
more discrete focal zones.
22. The apparatus of claim 12, wherein the transducer has an
imperfect focal region.
23. The apparatus of claim 12, wherein the apparatus is
disposable.
24. The apparatus of claim 12, wherein the electrical connectors
are arranged at a specific radius from the center of the seal so as
to match a corresponding set of connection rings in a socket of a
medical system.
25. The apparatus of claim 12, further comprising an inert gas
filled interior.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] The present application claims the benefit of provisional
U.S. Application Nos. 60/976,867 (Attorney Docket No.
021356-002800US), filed Oct. 2, 2007 and 60/908,074 (Attorney
Docket No. 021356-001320US) filed on Mar. 26, 2007, the full
disclosures of which are incorporated herein by reference.
[0002] This application is related to, and claims partial priority
from, Provisional U.S. Patent Application No. 60/908,074, entitled
"Interchangeable High Intensity Focused Ultrasound Transducer"
filed on Mar. 26, 2007. This application is also related to U.S.
patent application Ser. No. 11/027,912 entitled "Ultrasound Therapy
Head with Movement Control" filed on Dec. 29, 2004 and U.S. patent
application Ser. No. 11/027,919, entitled "Component Ultrasound
Transducer," also filed on Dec. 29, 2004. All identified
applications are herein incorporated by reference in their
entirety.
BACKGROUND OF THE INVENTION
[0003] The present invention relates to a sealing adaptor for use
with a interchangeable transducer for use within a wet environment
transducer housing.
[0004] Some high intensity focused ultrasound (HIFU) transducers
have limited life span because of the high power levels that may
tax their physical construction. These transducers degrade and fail
for a variety of reasons much faster than transducers used in other
medical fields (like diagnostic ultrasound, or other low power
applications). Transducers designed for therapeutic ultrasound
applications delivering therapeutic power levels may suffer
de-lamination of their metallization layers, pitting or physical
destruction of the transducer caused by cavitation or thermal
effects from exposure to very high temperatures.
[0005] To combat some of these side effects of HIFU operation,
system designs may use HIFU transducers below the threshold where
damage may occur to the transducer itself. Other systems use water
baths with degassed circulating water, or design their therapy
regimens with long intervals between therapy pulses. These extended
pauses between pulses produce a low pulse repetition frequency
(PRF) allowing the transducer to cool, and negative effects in
tissue to dissipate.
[0006] Unfortunately, some therapy regimen require HIFU with a
higher PRF, or continuous operation of the transducer for certain
lengths of time that preclude low PRF operation. These higher PRF
and/or continuous wave (CW) style regimen are desirable when the
treatment is designed to maximize the amount of tissue destruction
to be achieved in a certain period of time. In these types of
operations, transducer degradation necessitates a frequent
replacement of the HIFU transducer. Replacement is made difficult
in that the transducers are generally expensive and delicate
components, so handling the transducers is usually kept to a
minimum. Further more, transducers in therapeutic medical systems
are often imbedded into large bulk chambers filled with water, or
attached in a manner that precludes easy removal and replacement of
the transducer. The transducer environment may contain water, which
should not be permitted to mix with the system electronics. The
presence of water during a transducer exchange can make the
replacing of a transducer messy and difficult. Once the transducer
is replaced, water may linger between the electrical connectors
between the system and the new transducer. System performance may
be degraded due to electrode corrosion or signal cross-talk among
the conduction paths caused by the presence of water or other
fluids.
[0007] Thus it would be desirable to provide a transducer
connector, or connecting means, that provides an easier method of
removing and connecting transducers to a medical ultrasound device
that is compatible with the demands of a wet environment, and
capable of handling all system requirements without degradation in
performance.
[0008] Thus it is an objective of the present invention to provide
a connectorized transducer that can be connected to a therapy head
or medical system with as few steps as practical, while preserving
the environmental conditions of the connection.
[0009] Another objective is a connection that has a high
reliability and ease of use, to promote a user friendly procedure
for removing and/or installing transducers in the medical
system.
[0010] Yet another objective is to provide a transducer that
provides various features and operation parameters to expand or
broaden the type of transducers a user may connect with the medical
system.
[0011] Still another objective is a transducer that possesses the
necessary driving electronics particular to their designed
features, so as to reduce the required programming and electronics
of the main system.
[0012] Still another objective is to provide a simple disposal path
for used components.
[0013] Still another objective is a sealing device for electrical
signal isolation or electrical connector isolation in a wet
environment.
BRIEF SUMMARY OF THE INVENTION
[0014] These and other objectives are achieved through an
interchangeable transducer adapted for use with a high intensity
focused ultrasound (HIFU) medical system. The interchangeable
transducer has a housing that is generally rigid and hollow. The
housing has two open ends, one adapted for fitting a HIFU
transducer, and the other end having an isolation layer and
electrical connection for electrical signal and power communication
with the HIFU medical system. The interchangeable transducer is
adapted to fit into a socket style receptacle on the medical
system. The transducer is ideally replaced by the user, so the
portion of the transducer which fits into the socket is designed
for easy insertion and extraction. Easy insertion is achieved
through an orientation free, low engagement force connection
between the transducer and the medical system which allows easy
user access to the transducer.
[0015] A slip ring spacer is also described herein for use with a
wet electrical connection having a pancake style slip ring. The
slip ring spacer has a base formed from a non-conductive material.
Multiple apertures extend through the base. The apertures are
designed to sheath electrical connectors which extend through the
base. There are one or more flanges extending from the base. The
flanges are arranged so as to isolate the apertures into cells.
[0016] Additional embodiments and methods of making and using the
interchangeable transducer are also herein described.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] FIG. 1 shows an exterior view of an interchangeable
transducer.
[0018] FIG. 2 is a cut away view of an interchangeable
transducer.
[0019] FIG. 3 shows a system for use with an interchangeable
transducer.
[0020] FIGS. 4A-4E illustrate a method of swapping a
transducer.
[0021] FIG. 5A shows an exploded view of one embodiment of the
interchangeable transducer.
[0022] FIG. 5B provides an alternative embodiment of a PCB for use
inside the insert.
[0023] FIGS. 6A-6C show the interchangeable transducer connection
to the system socket.
[0024] FIGS. 6D-6E show the transducer insert using an alternative
PCB.
[0025] FIGS. 6F-6I illustrate a progression of possible adaptor
shapes.
[0026] FIGS. 7 and 8 show alternative PCB positions for the
interchangeable transducer.
[0027] FIGS. 9A-9E show a slip ring seal and a slip ring.
[0028] FIGS. 10-15C show alternative embodiments of the slip ring
seal.
DETAILED DESCRIPTION OF THE INVENTION
[0029] Described herein are various forms of replaceable
transducers for use with high intensity focused ultrasound (HIFU)
medical systems. The basic design of the interchangeable transducer
incorporates a housing which is hollow and generally rigid. The
housing holds within it a transducer, such as one compatible with
HIFU medical systems, electrical pathways (electronics) for
connecting the transducer to a medical system so the transducer can
be properly controlled, and a connector that allows the
interchangeable transducer to be removed and/or inserted into a
receptacle on the medical system. The transducer housing has a
shape and electrical connection assembly that allows the housing to
be inserted in any radial orientation relative to the system
receptacle axis. The axial symmetry may allow for two or more
orientations, and desirably an unlimited number of orientations.
For visualization purposes only, one may imagine the ease of
inserting a mini-plug for headphones into a portable music player.
The radial orientation of the plug to the receptacle does not
matter, and during use if the plug is rotated within the socket,
there is no interruption of the power and signal sent to the head
phones. This concept is analogous to the type of adaptor and socket
used in the interchangeable transducer connection described
herein.
[0030] In the following paragraphs, various aspects and embodiments
of the apparatus will be described. Specific details will be set
forth in order to provide a thorough understanding of the described
embodiments of the present invention. However, it will be apparent
to those skilled in the art that the described embodiments may be
practiced with only some or all of the described aspects, and with
or without some of the specific details. In some instances,
descriptions of well-known features may be omitted or simplified so
as not to obscure the various aspects and embodiments of the
present invention.
[0031] Parts of the description will be presented using terminology
commonly employed by those skilled in the art to convey the
substance of their work to others skilled in the art, including
terms of operations performed by or components routinely used in
ultrasound systems, medical ultrasound systems and HIFU systems. As
well understood by those skilled in the art, the operations
typically involve producing and controlling the wave form of the
transducer through a transmitter signal which generally uses well
understood electronics components and controllers. Signal control,
depends primarily on the desired objective for using HIFU. Novel
variations from prior art devices will be presented here in a
straight forward and simple manner so as to highlight the elements
necessary to practice the present invention, but not to be prolix
in description for those details which are well understood in the
art. The term system includes general purpose as well as special
purpose arrangements of these components that are stand alone,
adjunct or embedded.
[0032] Various operations may be described as multiple discrete
steps performed in turn in a manner that is most helpful in
understanding the present invention. However, the order of
description should not be construed as to imply that these
operations are necessarily performed in the order they are
presented, or even order dependent.
[0033] Reference throughout this specification to "one embodiment"
or "an embodiment" means that a particular feature, structure, or
characteristic described in connection with the embodiment is
included in at least one embodiment of the present invention. Thus,
appearances of the phrases "in one embodiment" or "in an
embodiment" in various places throughout this specification are not
necessarily all referring to the same embodiment.
[0034] The present invention relates to an interchangeable
transducer apparatus and methods of making the same, for use with
medical ultrasound systems, particularly those considered HIFU
medical systems.
[0035] The transducer described herein incorporates both novel
physical components and design, combined with existing materials in
a novel fashion to produce a transducer insert meeting one or more
of the objectives of the invention. The combinations of various
novel elements in one embodiment will meet some objectives, while a
different combination of novel elements will meet different
objectives. The collective whole of novel developments and
arrangements of existing parts contributes to a design that
satisfies the most objectives, though not necessarily all
objectives in a single design. Different objective requirements
will call for different combinations of the inventive concepts
herein described.
[0036] The transducer insert may be suitable for any number of
medical devices or medical systems desiring to use an easily
replaceable transducer. In pending U.S. patent application Ser. No.
11/027,912 "Ultrasound Therapy Head with Movement Control," filed
29 Dec. 2004 (commonly assigned and herein incorporated by
reference), a therapeutic ultrasound system is described having a
therapy head. The therapy head contains a first chamber, being wet,
in which a transducer is positioned. There is a second chamber,
which may be wet or dry, that contains a motor drive system. The
motor drive system uses one of several possible means to move the
transducer in the first chamber. Means described include use of
actuators that extend from the motor side chamber to the transducer
side chamber, a slide positioned on the motor chamber with a
magnetically connected transducer in the transducer chamber, or
various mechanical translation components for converting the work
produced from the motors into the movement of the transducer
through a barrier between the two chambers.
[0037] The interchangeable transducer, (also referred to herein as
a connectorized transducer or transducer insert), of the present
design is well suited for use in a therapy head of the previous
description. The interchangeable transducer or transducer insert is
formed from a housing having an adaptor end and an acoustic end.
There is a communication port at the adaptor end. The adaptor end
is designed to fit into a corresponding receptacle on or in the
medical ultrasound system. In one embodiment the transducer adaptor
end has a plurality of orientations for removably engaging a
receptacle in the medical ultrasound system. There is a transducer
at the acoustic end, and a means for electrical communication
between the communication port and the transducer.
[0038] The adaptor end may be a male or female type part, while the
receptacle would be the logical corresponding type part. While we
describe primarily a male adaptor and a female receptacle, it
should be understood that the adaptor end of the transducer insert
can be the female component while the system side receptacle is the
male component. The adaptor end and corresponding receptacle end
are designed in a manner to provide a plurality of working
orientations in which the transducer insert can be placed into the
system. In one embodiment the plurality of orientations may simply
be a slotted design for the adaptor and receptacle. The electronics
of the adaptor and receptacle are arranged in a manner as to allow
a "key-less" type of connection. Regardless of which orientation
the insert is placed into the receptacle, the insert will connect
with the system and operate properly. The connection between the
adaptor and receptacle may be any design having symmetry about an
axis, so the insert may be rotated about the axis so the insert can
be fit into the receptacle in at least two directions (normal and
flipped). If the connection is shaped like a triangle, three
orientations would be possible. For a square four orientations
would be possible. This dynamic continues to the logical and most
desirable shape of having a circular shaped adaptor where absolute
radial freedom is afforded. The insert may be placed into the
system receptacle at any radial orientation and proper electrical
connection is guaranteed. Regular shapes are not required to make
the adaptor connection. Irregular shapes may also be used so long
as they are symmetrical. The symmetry of the connection provides
the advantage to the user of not having to worry about the
orientation of the transducer insert relative to the system socket
(receptacle). So long as the shape of the connector matches the
receptacle the user knows the orientation will work.
[0039] Electrical communication is required from the ultrasound
medical system and the transducer within the transducer insert.
Electrical communication enters the transducer insert at the
communication side. Electrical communication means providing any
combination of power, signal or ground connections from the
transducer to the ultrasound system through the communication port
in the transducer insert. This communication can be achieved using
wires, cables, connector pins, or other electron conveying
instruments as known in the art. In one embodiment, the connection
may be wires running directly from the communication port to the
transducer in a "dumb" design, where no on board intelligence is
provided in the insert. In another embodiment, intelligence may be
incorporated into the insert by adding electrical components to an
electrical circuit used to provide electrical communication from
the communication port to the transducer. A variety of components
may be used in an intelligent design. Electrical components may
include a tuning transformer for optimizing the transducer, sensors
for measuring various parameters about the environment within the
transducer insert, sensors for monitoring the transducers
performance and/or safety, components for recording measured or
detected data, IC chips for running programmed applications or
storing information within the insert, or any other operation
desired.
[0040] In another embodiment of the present invention, the
electrical communication between the communication port and the
transducer may be provided by a two stage spring pin connection
scheme. A first stage set of connection pins connects the
communication port to an electrical circuit board. The circuit
board may be a PCB/PCBA and may further be a pancake slip ring
style PCB/PCBA. A second stage set of connection pins connects the
electrical circuit to the transducer. Electrical communication
enters the communication port from the ultrasound system. The
Electrical communication then travels to the electronic circuit.
The circuit board may provide the proper coordination and layout of
the various electrical components, and assures proper handling of
Electrical communication between the system and the transducer.
From the electrical circuit, Electrical communication continues to
the transducer. Any return Electrical communication from the
transducer may follow a similar route back from the transducer to
the circuit board, and then back to the system.
[0041] The insert may have various data recorders, sensors or
programmable components within it. These elements may be on the
circuit board. Various possible components that may be incorporated
into the insert include a chip for tracking the number of times the
transducer has been used, sensors which determine the proper
coupling between the transducer and the patient, sensors to
determine if the transducer is properly installed into the
ultrasound system, or sensors to determine the safe operation of
the transducer while providing therapy output. There may also be a
tuner for a second transducer such as an "A" line transducer for
providing simple imaging information to the user or to the
system.
[0042] The transducer insert may also be constructed to operate
with a component style ultrasound system such as those described in
U.S. patent application Ser. No. 11/027,919 entitled "COMPONENT
ULTRASOUND SYSTEM" and filed on Dec. 29, 2004 (commonly assigned
and herein incorporated by reference). In this embodiment, the
insert has an adaptor for fitting to an ultrasound system having
two or more identical sockets for receiving more than one type of
insert, where one of the inserts may be a transducer insert as
described herein. In a component ultrasound transducer, there are
two or more sockets in the therapy head. The sockets are identical
and the inserts used within the sockets may be plugged into any one
of the sockets, Each insert has a challenge and recognition
component programmed in it, so when the insert is plugged in, the
ultrasound medical system can identify each individual insert and
know how to properly use it. The system can handle multiple kinds
of inserts simultaneously. Each insert may have a different focal
depth, performance parameter or use requirement, the system can
determine and properly handle the proper operation of all inserts.
Desirably the transducer inserts would be properly utilized by the
system automatically (without specialized user contribution or
instruction to the system other than that used for a single
receptacle ultrasound system using a transducer insert).
[0043] Use of modern materials and electronics greatly reduces the
costs of manufacturing transducers for the medical ultrasound
systems disclosed herein. This cost reduction and ease of
manufacturing allows replacement parts to be disposable when worn
out or no longer desired.
[0044] In addition to the transducer insert described herein, a
novel structure is now disclosed allowing an electrical connection
to be made in a wet environment. The novel structure is a slip ring
seal, designed for use with a pancake style slip ring PCB. The slip
ring seal has a base, two or more apertures extending through the
base, and flanges extending from the base to isolated the apertures
into cells. The flanges may define cells discretely formed around
each aperture, or around a select group of apertures, or a
combination of the two.
[0045] The connection between the transducer insert and the system
is generally a wet environment. Particularly during operation of
the transducer the chamber in which the transducer is located is
fluid filled. Various fluids are suitable for use in the transducer
chamber where the transducer of the present description can be
used, in general water is the most common fluid used due to ease of
availability, cost and performance characteristics. Reference
herein to fluids or water should be understood to incorporate which
ever fluid is most suitable for the intended use and design of the
transducer, since not all operations will prefer water when another
compatible fluid may be superior for the particular
application.
[0046] Now turning to the accompanying drawings, it should be
understood the drawing figures are provided to enhance the
description provided. Elements shown in the figures are not
necessarily illustrated to scale with respect to other drawings, or
other parts within the same drawing. The parts or figures should
not be taken in any absolute sense of actual design elements other
than as illustrations of embodiments for the purpose of
understanding the disclosure herein.
[0047] A simplified exterior view of the interchangeable transducer
10 is shown in FIG. 1. The transducer 10 has a housing 16
represented as generally cylindrical. The housing 16 is desirably
rigid and hollow. The housing 16 has a transducer end 20, and an
electrical connector and sealed end 14. External electrical
connectors 40 extend through the seal end 14 and are designed to
connect to the appropriate electrical lines from the medical
system. These may include a transmit/receiver line, ground and
power. Additional lines may be provided depending on the need or
application of the medical system. The interchangeable transducer
need only have addition electrical connectors and support circuitry
to enable those capabilities. An adaptor 32 is also provided to
allow physical engagement of the transducer 10 to a HIFU medical
system.
[0048] A simplified interior view of the interchangeable transducer
10 is now illustrated (FIG. 2). Once again the seal end 14 has
external electrical connectors 40 for electrical connection to a
medical system. The external electrical connectors 40 may extend
through the seal end 14 to connect to a component within the
housing 16, or there may be an intermediate connection through the
seal end from the interior of the housing. Desirably the external
connectors extend through the seal end to provide electrical
contact between the socket of the medical system, and the interior
of the interchangeable transducer. The transducer 22 is shown at
the bottom or lower section of the housing 16. The transducer 22 is
electrically connected to the connectors 40 by wires 12. Electrical
signals from the ultrasound system to the transducer 22 (or
visa-versa) may include power, ground, transmit, receive, data or
other signals and information as desired. The housing may also
contain one or more electrical components as part of the
transducer's control circuit.
[0049] The interchangeable transducer 10 has a connector or other
adapter allowing it to engage into a receptor on a medical device
system (FIG. 3). A medical system 300 that might use an
interchangeable transducer as described herein, is shown having
base 302, an articulating arm 304, with a display screen 306 and a
therapy head 308. Within the therapy head 308, there is an adaptor
for receiving an interchangeable transducer. A computer or other
electronic intelligence (CPU) is also provided to operate the
system 300 and the transducer 10.
[0050] The internal components of the therapy head 308 are
generally described along with the method of changing out
transducers (FIGS. 4A-4E).
[0051] Any water or other fluids in the therapy head 308 are
desirably drained from the therapy head so that water does not
splash out of the therapy head when opened. Having water or other
fluids in the therapy head is not an impediment to the removal and
installation of transducers described herein, so it is not
necessary to completely drain the therapy head. In one embodiment
the therapy head 308 is inverted, so the main transducer chamber
310 is positioned on the bottom. The therapy head 308 has a
removable cap 312 section, with a transmission window 316 (FIG.
4A).
[0052] The cap 312 is removed (FIG. 4B) exposing the interior of
the therapy head transducer chamber 310. The interchangeable
transducer 10 is connected to a receptor socket 38. A pair of water
lines 320 are used to circulate water inside the transducer chamber
when the cap 312 is sealed to the transducer housing 310. There are
mating flanges 322 on the treatment cap 312 and bulkhead 324 that
contain an O ring seal on the transducer housing 310 that when
assembled create the water tight seal of the chamber (not shown).
Under the receptor 38, the transducer chamber may have motors or
motor cams 326 or drive shafts connected to a mechanical drive
system for moving the receptor 38.
[0053] Once the cap 312 is removed, the interchangeable transducer
10 can be removed (FIG. 4C). Desirably the transducer can be lifted
straight out of the receptor 38, or detached from the receptor with
a minimal amount of force (like twisting or rocking). The empty
receptor 38 has a PCB slip ring which may get wet during this step,
and the presence of water on the PCB is of no concern.
[0054] A new transducer 10' is now seated onto the receptor 38 in
place of the old transducer 10 (FIG. 4D). Again the insertion force
for placing the new transducer 10' is desirably fairly low,
allowing any user to insert the new transducer 10' easily and
quickly. The round shape of the transducer plug and the receptor 38
allow for any radial orientation when the new transducer 10' is
seated into the receptor 38. The cap 312 is then repositioned over
the transducer chamber 310 to re-form the therapy head 308 (FIG.
4E).
[0055] Once the new transducer is in place, it may be desirable to
refill the water chamber, activate the medical system 300, and
allow the system to communicate with the new transducer 10' to
ensure the transducer is properly seated in the receptor 38, and
that the transducer is responding normally. The system may use a
`challenge and answer` protocol to determine the nature of the
transducer, and establish the appropriate therapy regimen to use
with the particular transducer. The transducer 10 may have an
integrated circuit (IC) 30 on board that can provide detailed
information to the medical system once it is properly connected.
Alternatively the IC may be used for other purposes (see
below).
[0056] A connector or adaptor 32 is shown on the outside of the
housing 16 (FIG. 1). The connector 32 allows the transducer housing
16 to mate with a socket or receptacle 38 of a medical system 300.
The connector 32 desirably allows the housing 16 to be inserted
into the socket or receptacle with a low insertion force to provide
easy insertion or removal. The electrical connectors 40 are
designed to operate in conjunction with the mechanism used to mate
the transducer 10 to the receptor 38, so the electrical connectors
40 can establish and maintain contact with the appropriate system
side electronic channels regardless of the radial orientation of
the transducer when mated to the receptor. The connector 32
similarly can engage the socket 38 in any radial orientation. The
receptor or socket 38 has a receiving element 36 for the connector
32. The connector 32 for engaging the socket may be mechanical,
magnetic or electromagnetic in nature. As long as the connector can
hold the transducer housing in its proper place in the socket and
allow for any radial orientation for insertion and removal, the
connector will be sufficient for the intended use.
[0057] The interchangeable transducer assembly is now described
(FIG. 5A). In this embodiment, the housing 16 is made from two
sections, a lower portion 16B for receiving the transducer 22, and
an upper portion 16A adapted for connection with the medical system
socket 38. The transducer 22 is shown having a set of pin receptors
24r where the electrical pins 24 attach to the transducer. The
electrical pins 24 extend from the interface 28 to the transducer
and pass through the concentric liner 26. Desirably the liner has
apertures for lining up the connection points on the interface and
the transducer. An optional transformer 42 can be connected to the
interface 28, and would sit within the aperture defined by the
concentric liner 26.
[0058] The lower portion 16B may be assembled by first inserting
the transducer 22 into the lower portion 16B. The transducer 22 may
be secured using epoxy or resin along the transducer rim to seal
the transducer to the aperture defined by the housing opening 20.
The electrical connector pins 24 are inserted into the concentric
liner 26, and then the connector pins 24 are oriented to match the
transducer receiver placements 24r. The concentric liner 26 is then
placed into the lower portion and secured. Electrical components
such as the transformer 42, or the data IC (not shown) may be
attached to the PCB 28, and then the PCB 28 is lined up to match
the desired connector pin 24 layout. The PCB 28 has predefined
lands on both its upper and lower surface. These lands correspond
to the pin orientation for the electrical connector pins 24 of the
lower portion, and for the electrical pins of the upper portion
40.
[0059] The upper portion 16A is similarly assembled. The upper
portion is sealed across the top, and the electrical pins 40 that
extend through the top of the upper portion 16A are sealed against
fluid flow from the outside of the housing to the inside. The
electrical pins 40 may be soldered in place, or fixed with an epoxy
or other agent to provide the fluid seal between the upper portion
16A and the apertures needed for the pins. The upper connector pins
40 are inserted through the isolation layer 34 in a predefined
arrangement matching the upper lands of the PCB 28. The connector
pins may be any type of electrical pins suitable for use in an
interchangeable design. Spring pins, pogo-pins, spring clips and
other tensioned electrical connectors are desirable in one
embodiment due to their expansive nature. Spring loaded connectors
allow a greater margin of safety in physical distance between the
transducer and PCB. Once the connection pins 40 are in place, the
isolation layer 34 is lowered into the upper housing 16A. The
isolation layer 34 is desirably attached to the upper portion so
that the upper housing 16A and isolation layer 34 can be moved as a
single unit. The isolation layer 34 may be attached using an
adhesive compound between the isolation layer and the top of the
upper housing. Alternatively the isolation layer 34 may be
constructed so there is an interference fit between the isolation
layer and the upper section of the housing. Desirably the adhesive
or interference fit would prevent water from pooling underneath the
isolation layer and the housing. The upper housing is then lowered
onto the lower housing assembly so the connector pins 40 match the
PCB land layout (FIG. 5A). The entire transducer housing may be
filled with an inert gas to promote stability and operational life
span of the internal components.
[0060] In an alternative embodiment, the transducer insert 10
replaces the standard PCB 28 with a slip ring PCB 29 (FIG. 5B). In
this embodiment there are discrete lands LD or traces for direct
attachment to particular components (transformer, IC chips, etc. .
. . ) as well as traces made into slip rings 102a-i for connection
to various connectors. In this embodiment the transducer insert
realizes an advantage in assembly by having electrical
communication with portions of the transducer insert not directly
attached to the PCB 29 in that those non attached components are
free from discrete orientation relative to the PCB 29. Parts
desirably directly connected to the PCB 29 would connect to
discrete lands sites LD, while pin connections 24, 40 could connect
to the land rings. The transducer 22 may also have a land ring
instead of discrete connection points 24r. By utilizing land rings
in the various components within the transducer, freedom from
particular orientations are achieved, and thus provide advantages
in manufacturing/assembly of the parts and sub components.
[0061] Although the medical system socket 38 is illustrated (FIG.
5A), this component is not a part of the interchangeable transducer
10, and is merely illustrated here to show the alignment of all the
parts described. Desirably the socket utilizes a pancake style slip
ring to improve contact regardless or radial orientation.
[0062] The transducer used in the interchangeable transducer design
may have a single fixed zone, or be designed having two or more
focal zones. The transducer may have an imperfect focal zone
achieved through a mechanical distortion formed in the transducer,
such as those described in U.S. patent application Ser. No.
10/816,197 entitled "VORTEX TRANSDUCER" and filed on Mar. 31, 2004,
and U.S. patent application Ser. No. 11/439,706 entitled "Medical
Ultrasound Transducer Having Non-Ideal Focal Region" filed May 23,
2006. (both applications commonly assigned and herein incorporated
by reference). The vortex transducer and the non-ideal focal region
transducers allow for a focal region in a circular or donut shaped
pattern wherein the pattern is produced by a mechanical offset in
the bowl of the transducer. The isolation layer 34 is primarily
used to prevent electrical cross talk and contact corrosion among
and between the electrical contacts 40. The shape and size of the
focal region can be mathematically calculated and an appropriate
mechanical shape to a transducer can be manufactured. This allows
the transducer to focus ultrasound waves in particular desired
shapes and patterns without requiring the complexity and cost of an
electronically steered transducer. The transducer may also be an
electronically focused device, such as a 2D array or a phased array
transducer.
[0063] Internal details of the transducer-socket connection are now
described (FIG. 6A). In one embodiment, there is a housing 16
having a substantially cylindrical shape. The housing 16 has a neck
down region located near the isolation layer 34, and a larger
diameter near the transducer 22. The transducer side 20 is open, or
has a window so ultrasound energy may be broadcast out of the
housing 16 unimpeded. The transducer 22 is secured near the open
end 20, and connects to an interface 28 via a set of connection
pins 24. The connection pins 24 are held in place with a concentric
liner 26 inside the housing 16. The interface 28 may be a set of
connecting wires as previously described, or may include a circuit,
PCB, PC(B)A or other hardware component. The interface may also
have additional electronics, such as a transformer 42 for tuning
the transducer 22, a data chip or integrated circuit (IC) 30 to
help identify the interchangeable transducer 10 to the medical
system 300. Additional components are described below.
[0064] Opposite the transducer 22, there is a seal 14 for
preventing water or atmosphere from entering the internal
compartment of the transducer 10. Working in conjunction with the
seal 14 is an isolation layer 34 for reducing pin corrosion and/or
cross talk between the external electrical connectors 40. Note the
transducer side 20 is also sealed against the outside environment.
While the transducer side 20 may be sealed with the transducer 22
itself and various compounds which can be used to prevent leakage,
the seal 14 has one or more apertures 50 for the protrusion of the
external electrical connectors 40. The apertures 50 are desirably
large enough to allow the passage of the electrical connectors 40.
The apertures may rely on an interference fit to prevent seepage of
fluid between the apertures and the pins, or the use of a sealing
agent, or both. The apertures 50 may be sealed once the external
electrical connectors 40 are placed using solder, epoxy, resin,
adhesive or other suitable sealing agents. A connector 32 is
located on the housing and designed for engagement of a
corresponding connection on the medical system socket 38. The
receiving element 36 and connector 32 form a transducer-system
connection. This connection is desirably one having high endurance.
Repetitive reliability is desirable, but not required for the
transducer connector 32, as it is not envisioned that any one
particular transducer will be removed and inserted a large number
of times.
[0065] The design of the transducer connector 32 and the system
side connection (receptor) 36 allow for individual transducers to
be interchanged with the medical system 300 on demand. This allows
a single medical system to have a great deal of variety in its
operational scope. Each new transducer can provide added capability
as well as replacement for worn or out dated parts. Desirably the
mating of the transducer 10 to the system 300 can be accomplished
with a low insertion force connector 32 and receptor 36
combination. Though the insertion force is low, the connection is
robust so the transducer 10 will be stable while mounted in socket
38. The socket 38 is desirably connected to a motor assembly
through a set of cams 326. Electrical communication between the
system 300 and the transducer 10 is maintained regardless of how
the socket 38 might be moved.
[0066] The electrical pin 40 layout as they extend through the seal
34 are designed to make contact with additional lands built into
the socket 38 (FIG. 6B). The socket lands 102a-c form concentric
structures within the socket. There are isolation rings 104 between
the electrical connection lands. The electrical pins 40, now
identified individually 40a, 40b, 40c (FIG. 6B) each carry a
separate electrical signal from the medical system 100 to the
interchangeable transducer 10. The individual connectors may carry
power, transmit/receiver signal information, IC chip detection,
ground or other signals as desired. The corresponding lands in the
socket PCB form concentric rings for connection with each pin
separately. This is achieved by arranging the electrical pins 40a-d
at a discrete radius from the center of the transducer connector
end. Then the transducer housing engages the socket, the pins of
the transducer housing match up to the appropriate concentric lands
of the slip ring. In this fashion, even if the transducer is
rotated within the socket, the proper electrical pin 40a-c always
remains in contact with the corresponding land ring forming
corresponding pin-land connections 102a-40a, 102b-40b, 102c-40c.
There is no limit to the lands 102.times. and connector pins
40.times. and as many pairings as are desired may be incorporated
into the design. When the transducer is mated with the system, the
electrical pins and PCB lands match up, and provide a secure
electrical connection (FIG. 6C). The pressure used to hold the
removable transducer 10 in place with the system side socket 38
desirably provides sufficient force exerted on the isolation layer
34 to prevent fluid from seeping into the region between the
isolation layer 34 and the recess of the housing 16A where the
isolation layer is placed. The isolation layer may also be
manufactured with flanges on the bottom (not shown) so that
isolation layer forms discrete channels or chambers for each
electrical connector, or groups of connectors, as the flange or
ridge configuration on the top side of the isolation layer.
[0067] The pin layout and slip ring described herein and shown in
the figures represents one embodiment, however this embodiment is
not meant to be limiting of the connector layout. The number of
electrical pins in the "plug" end of the transducer may be as many
as desired or needed to perform the necessary tasks of providing
electrical connection, or even stabilizing plugs for structural
integrity. The lands of the slip ring like wise may be as many as
desired and it does not necessarily follow that each land will have
a corresponding electrical connector. A land may be used as a
cross-talk sensor by having no physical pin designed to make
contact with it, yet still monitor electrical signal when the
connection is made. The land itself can be used as an electrical
sensor to monitor the safety and stability of the electrical
connection and/or the isolation between lands.
[0068] An alternative embodiment using the pancake slip ring PCB 29
in the insert is now described The transducer insert resembles the
assembly previously described. Individual components such as a
transformer 42 are still directly connected to the modified PCB 29
(FIG. 6D). The electrical pins 24, 40 are no longer connected to
discrete traces on the PCB 29. The electrical pins 24, 40 are now
pressed against the trace rings 102a-c on the PCB 29. This allows
the top section 16A and bottom section 16B to be press fit together
without regard to the orientation of the parts relative to each
other. No matter what orientation the top 16A has to the bottom
16B, the electrical pins 24, 40 will still match up with the traces
to provide proper electrical communication from the communication
port to the transducer.
[0069] In another embodiment using either the standard PCB 28 or
the slip ring PCB 29, the transducer 22 may have a trace ring 24LR
around the circumference of the transducer so the transducer may
also be assembled to the bottom 16B section without concern for
orientation and placement of the electrical pins 24 to the
transducer 22.
[0070] A close up of the electrical pin connections 40 to the top
of the slip ring PCB 29 is now shown (FIG. 6E). Here the discrete
connections for the transformer 42 are shown in the form of a
series of discrete lands LD or trace positions.
[0071] The adaptor for the transducer insert 10 need not be
circular, though the circular design is desirable. Various other
shapes allowing for multiple orientation of the transducer insert
are shown in FIGS. 6G-6I. To simplify the process of replacing the
transducer insert 10 for a user, the transducer adaptor has a
"keyless" orientation to the "socket" on the system side. So the
adaptor may be oblong for two orientations, triangular for three
orientations, progressing to a circular insert and socket (FIG.
6I). There is also no restriction on the shape of the adaptor as
being a regular shape, so long as the adaptor shape is symmetrical
about one axis so the adaptor can still mate with the ultrasound
system when it is oriented in another symmetric alignment.
Regardless of the physical shape of the insert connector and
socket, the socket has electrical contacts in the form of slip
rings (dotted lines in FIGS. 6F-6I), with electrical contact pins
set at the desired radius to make physical contact with the
corresponding land so the appropriate pins 40a-x communicates with
the corresponding lands 102a-x.
[0072] The orientation of the interface 28 as shown in FIGS. 5,
6A-6C need not be perpendicular to the axis of the transducer
housing. The interface 28, along with any additional components may
be at any orientation desired. In one embodiment, the interface 28
is a PCB or PCA aligned with the axis of the housing 16 (FIG. 7)
and has connection wires 12 from the external electronic connectors
40 to a PCB style interface 28 having a transformer 42 and a data
IC 30 along with other electronics as may be desired.
[0073] In another embodiment, the interface may be a PCB with a
data IC having additional embedded information. The data IC 30 may
include data related to the number of uses the transducer is
allowed to be activated, or it may record use data which can be
used to help improve future interchangeable transducer designs
(such as measuring attenuation, feedback, decoupling, thermal
information or the like). While this collected data may be stored
in the data IC, additional sensors 4021-i could be added to the
interface 28 to record the desired data (FIG. 8).
[0074] The isolation layer 34 used with the interchangeable
transducer may be a washer or disk of electrical isolation
material. While the isolation layer may be a solid or otherwise
uniform component, an independently novel design for an electrical
isolation layer is desirable.
[0075] An isolation layer well suited for providing isolation
between individual contacts in a wet environment is realized in the
form of a slip ring seal (spacer). The slip ring spacer is provided
at the docking end of the connectorized transducer. The slip ring
spacer may have any one of a variety of forms consistent with the
general description and requirements described herein, or similar
or equivalent to any of the enumerated embodiments described. The
slip ring spacer provides a bumper between the connectorized
transducer and the socket of the medical system. Furthermore, the
seal provides apertures or other means of allowing electrical
communication through the seal, between the connectorized
transducer and the socket. In addition, the seal allows for
simultaneous electrical communication between multiple isolated
electrical connectors in a wet environment. The seal provides
isolation of each separate electrical connector type, reducing
cross talk between different kinds of signal and/or power
connectors. The slip ring seal is desirably made from or has
properties incorporated into it, that provide water and electrical
resistance. If the material is slightly conductive, it is possible
for a short to occur between the electrical pins even in the
presence of a partial or complete fluid seal.
[0076] A slip ring spacer is now described as shown in FIGS. 9A-9E.
The slip ring spacer 900 has a base 902 and one or more flanges or
ridges 9041-i rising from the base. The ridges or flanges are
adapted to press against a slip ring SR and form one or more
concentric channels 9061-i so that each electrical connection ring
of the slip ring SR is separated from the other electrical
connection rings by the ridges 9041-i. When the slip ring seal 900
is pressed against a slip ring SR, channels 9061-i are formed by
the ridges or flanges of the slip ring. The ridges are pressed
against the slip ring SR, forming a seal against fluid flow between
the discrete channels 9061-i. The slip ring forms one barrier to
fluid movement while the slip ring seal forms the sides and bottom
of the channels. In this way, electrically conductive fluid is
restricted from flowing between the channels, and exposure to the
electrical pins is reduced. This minimizes corrosion and cross-talk
among and between the electrical pins. The base desirably has
apertures for electrical pins or connectors for making contact with
the electrical connection rings on the slip ring. In operation, the
slip ring spacer 900 allows each connector to communicate with a
corresponding slip ring pad without producing cross talk between
other channels, even if the environment is wet.
[0077] The pin connectors may be organized into groups so that
multiple pins may be intended to make contact with a slip ring
land. In this case the pins may be organized into groups, similar
to the two pins 40b, 40i sharing a single circular channel (FIG.
9A). This illustration is an example of more than one pin designed
to make contact with a single land, and there is no limit to the
number of pins that can be grouped into a single channel or group,
or the number of groups that can be used in the interconnection
arrangement between the transducer and the socket.
[0078] Alternatively the slip ring spacer may have flanges or
ridges on the underside of the base (not shown) in a pattern
similar to the flange or ridge pattern on the top surface of the
spacer. The presence of flanges or ridges on the bottom of the
spacer can help isolate the electrical contact pins from one
another in the event fluid seeps below the slip ring seal during
operation.
[0079] The slip ring spacer 900 may utilize numerous alternative
embodiments. The slip ring spacer 900 has individually isolated
electrical pin zones (FIG. 10). In this embodiment each aperture 40
of the slip ring spacer 900 has one or more rising ridges 904
surrounding each aperture. The outer rim of the base 902 is also
encircled with a flange or ridge 904R to minimize water or fluid
flow from the outside of the connector to the inside components.
The individual electrical pins that would protrude through the
apertures are individually insulated to reduce the risk of
electrode corrosion and/or cross talk.
[0080] A single spiral channel can be formed with a spiral shaped
ridge (FIG. 11) with periodic partitions placed in the spiral
pattern. The spacer may use various arrangements of ridges or
flanges extending from the base. The ridges may be tapered, block
shaped, or arranged in a series of thin partitions operating as a
group (FIGS. 12A-12C). Desirably the spacer is made from material
that has high water and electrical resistance (like rubber, RTV
(Room Temperature Vulcanization) silicone rubber, polymers, etc. .
. . ). The material desirably has a durometer low enough to allow
the flanges or ridges to deform when they are pressed against a
slip ring so the flanges will deform slightly to seal against the
slip ring. Designs that are more structurally robust desirably have
a lower durometer material with a wider area of contact (FIGS. 12A,
12B) while configurations of the seal having a more rigid
construction may use material that is a higher durometer material,
but a reduced area of contact (FIG. 12C).
[0081] In another embodiment the spacer has a top portion that can
compress directly on to the slip ring, and pressure pressure forces
any fluid out of the surface area of the slip ring itself so the
electrical connection can be made relatively free of any fluid. In
another embodiment, temporary channels 1301 may join the apertures
for the electrical pins, to the outer circumference of the slip
ring seal so water may escape or be forced away from the electrical
pin outs (FIGS. 13A-13B). As the seal is pressed against the slip
ring, the channels are compressed against the slip ring surface,
and thus reducing the flow of fluid among the electrical
connections to a level where cross talk between the slip ring lands
is acceptable.
[0082] In yet another embodiment of the spacer, the spacer may
comprise a water and electrically resistant material having a web
like structure (FIG. 14A-14C). Gap spaces between the webbing serve
as apertures for the electrical pins to protrude from the
transducer and the medical system socket. Optionally the webbing
may have additional material between the web strands to further
restrict water flow between the web strands when the slip ring seal
is compressed into position between the interchangeable transducer
and the system socket. As the spacer is pressed against the slip
ring while the connectorized transducer is pushed into the socket
of the medical system, the webbing with or without additional
material in the webbing) collapses and presses fluid out of the
cells and away from the electrical connectors. The collapsed
webbing forms a barrier to fluid flow between the web strands. The
webbing may be organized (FIGS. 14A-14C) or randomly distributed in
the formation of the seal (FIGS. 15A-15C).
[0083] In operation, a transducer as described herein can be
removed from a socket, and then a new one inserted without regard
to the radial orientation of the transducer relative to the socket.
If the environment containing the socket is wet, the seal on the
transducer allows the transducer housing to make good connection on
the electrical lands on the socket side, while ensuring solid
connection with the transducer and internal workings of the
interchangeable transducer. Seams or assembly joints may be sealed
with resin or epoxy if needed. Seams and assembly joints may also
be sealed with solder, ultrasound welding or similar
techniques.
[0084] In addition to the embodiments described above, alternative
interconnect schemes suitable for use with the present invention
are now described. Alternative transducer signal connections
include using direct electrical connection via pin and socket,
direct electrical connection via soldered spring contact and PCB
trace, direct electrical connection via PCB trace to floating
spring contact (e.g. in carrier) to PCB trace, direct electrical
contact via a post and socket with multiple connections (e.g.
stereo headphone jack), as well as wireless types of interconnects,
such as inductive coupling, and capacitive coupling.
[0085] The transducer can be secured within the housing by gluing
it or mechanically affixing it to the housing. The transducer may
be sandwiched between a preformed lip in the housing and the
electrical connection pins 24. In another embodiment the transducer
may be attached using a soluble adhesive allowing for the
transducer ceramic to be replaced when the interchangeable
transducer fails.
[0086] Structurally the physical connector between the transducer
housing and the socket may be combined with the electrical
connectors. One may visualize a series of stacked electrical
connector rings designed to match up to corresponding pin
connectors within the socket. Alternatively the relationship of
socket and insert may be reversed so the transducer has a socket
for receiving a male end adaptor from the medical system.
[0087] In other embodiments, the physical connection between the
transducer housing and the socket can be achieved through any low
force insertion mechanism suitable for the medical system and
medical procedures desired. These may include a bearing ring, a
snap ring, or simply frictional engagement. Rotational capability
of the transducer housing within the socket is not critical, so
long as the transducer electronically connects to the medical
system electronics through the unaligned electrical
connections.
[0088] Additional alternative embodiments of the present invention
will be readily apparent to those skilled in the art upon review of
the present disclosure. The lack of description or the embodiments
described herein should not be considered as the sole or only
method and apparatus of providing for an interchangeable
transducer. The scope of the present invention should not be taken
as limited by the present disclosure except as defined in the
appended claims.
* * * * *