U.S. patent application number 11/983851 was filed with the patent office on 2008-03-20 for imaging and therapeutic procedure for carpal tunnel syndrome.
This patent application is currently assigned to DePuy Products, Inc.. Invention is credited to Robert J. Dunki-Jacobs, Conrad Lee Klotz, Inder Raj S. Makin, Sarah E. Stephens.
Application Number | 20080071165 11/983851 |
Document ID | / |
Family ID | 39189541 |
Filed Date | 2008-03-20 |
United States Patent
Application |
20080071165 |
Kind Code |
A1 |
Makin; Inder Raj S. ; et
al. |
March 20, 2008 |
Imaging and therapeutic procedure for carpal tunnel syndrome
Abstract
A system, method and/or apparatus is provided for visualization
or imaging of the transverse carpal ligament and surrounding
structures/features of a hand of a patient, and treatment of the
transverse carpal ligament, particularly, but not necessarily, for
performing non-invasive carpal tunnel release. The subject
invention utilizes ultrasound waves preferably, but not
necessarily, in the high frequency range and cavitations to image
the transverse carpal ligament (TCL), record its location in
three-dimensional space, and perform precision treatment on the
transverse carpal ligament. Treatment may range from stretching or
lengthening the TCL to complete tissue ablation or dissection of a
portion or portions of the TCL (as is performed in a standard
carpal tunnel release procedure) in order to release pressure
within the carpal tunnel. Particularly, high temperature conditions
are generated at target tissue of the TCL resulting in elongation
or necrosis/dissection. The subject system, apparatus and/or method
provides the surgeon to relieve a patient of carpal tunnel syndrome
symptoms in a bloodless, efficient, and accurate manner.
Inventors: |
Makin; Inder Raj S.;
(Loveland, OH) ; Klotz; Conrad Lee; (Nappanee,
IN) ; Stephens; Sarah E.; (North Webster, IN)
; Dunki-Jacobs; Robert J.; (Mason, OH) |
Correspondence
Address: |
MAGINOT, MOORE & BECK, LLP;CHASE TOWER
111 MONUMENT CIRCLE
SUITE 3250
INDIANAPOLIS
IN
46204
US
|
Assignee: |
DePuy Products, Inc.
Warsaw
IN
46581-0988
|
Family ID: |
39189541 |
Appl. No.: |
11/983851 |
Filed: |
November 13, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10881409 |
Jun 30, 2004 |
7303555 |
|
|
11983851 |
Nov 13, 2007 |
|
|
|
10610463 |
Jun 30, 2003 |
7135017 |
|
|
10881409 |
Jun 30, 2004 |
|
|
|
Current U.S.
Class: |
600/411 ;
600/439; 601/3 |
Current CPC
Class: |
A61B 8/14 20130101; A61B
2090/378 20160201; A61N 2007/0078 20130101; A61B 2090/374 20160201;
A61N 7/02 20130101 |
Class at
Publication: |
600/411 ;
600/439; 601/003 |
International
Class: |
A61N 7/02 20060101
A61N007/02; A61B 5/055 20060101 A61B005/055 |
Claims
1. A system for treating a target area with frequency treatment
signals comprising: an imaging system for identifying a target area
for application of frequency treatment signals; a treatment system
for applying a frequency treatment signal to the identified target
area.
2. The system of claim 1 wherein the treatment system applies an
ultrasonic signal in the range of about 100 KHz to about 50
MHz.
3. The system of claim 1 wherein the treatment system applies an
ultrasonic signal in the range of about 20 KHz to about 100
KHz.
4. The system of claim 2 wherein the imaging system is a magnetic
resonance imaging system.
5. The system of claim 1, the treatment system further comprising:
a probe having at least one transducer that generates the frequency
signal in the form of an ellipsoid field.
6. The system of claim 1, the treatment system further comprising:
a probe having at least one transducer that generates the frequency
signal in the form of a circular spot field.
7. The system of claim 1, the treatment system further comprising:
a probe having at least one transducer that generates the frequency
signal in the form of a rectangular spot field.
8. The system of claim 1, the treatment system being controlled to
apply a second frequency treatment signal to the identified target
area, the second frequency treatment signal having a frequency that
is different than the first applied signal.
9. The system of claim 1 wherein the treatment system is controlled
to apply the second frequency treatment signal contemporaneously
with the application of the first applied signal.
10. The system of claim 9, the treatment system further comprising:
a first transducer for application of the first frequency treatment
signal to the target area; and a second transducer for application
of the second frequency treatment signal to the target area.
11. The system of claim 1, the treatment system applying the
frequency signal to the target area while the target area is being
treated with drug therapy.
12. The system of claim 1, the treatment system including a probe
for applying the frequency signal through epidermal contact in the
vicinity of the TCL.
13. The system of claim 12, the probe of the treatment system
having one of a linear array, curved array, or a tightly curved
area probe.
14. The system of claim 1 wherein the treatment system generates
multiple frequencies for application to the target area and applies
each frequency for a specified application time.
15. The system of claim 1, wherein the imaging system is controlled
to measure a selected parameter following application of the
frequency signal to determine the effectiveness of the frequency
signal application.
16. The system of claim 1, wherein the imaging system measures a
parameter selected from the group comprised of target area density,
acoustic speed through the target area, signal attenuation in the
target area, and linearity of the target area's response to the
frequency signal.
17. The system of claim 1 wherein the imaging system is a spatial
compound ultrasound imaging system.
18. The system of claim 1 wherein the imaging system is a computed
tomography imaging system.
19. The system of claim 1 wherein the treatment system includes a
surgical probe for the subcutaneous application of the frequency
signal to the target area during an endoscopic procedure.
20. The system of claim 1 further comprising: a plurality of
transducer array banks, a plurality of ultrasound signal generators
for specifying a frequency for each transducer array bank in the
plurality of transducer array banks; and a controller for providing
a frequency to each ultrasound generator in the plurality of
ultrasound signal generators.
Description
[0001] This application is a continuation of co-pending application
Ser. No. 10/881,409, filed on Jun. 30, 2004 (Patent Application
Publication No. US 2005/0038423) and entitled "Imaging and
Therapeutic Procedure for Carpal Tunnel Syndrome", which in turn is
a continuation-in-part application of U.S. Ser. No. 10/610,463,
filed on Jun. 30, 2003 and entitled "Imaging and Surgical Procedure
for Carpal Tunnel Syndrome" (now U.S. Pat. No. 7,135,017). The
disclosures of each of the above-identified patent(s) and patent
application(s) are hereby totally incorporated by reference in
their entirety.
REFERENCE TO RELATED APPLICATIONS
[0002] Cross-reference is also made to related co-pending U.S.
patent application Ser. No. 10/610,474 filed on Jun. 30, 2003 and
entitled Surgical Scalpel and System Particularly For Use In a
Transverse Carpel Ligament Surgical Procedure.
FIELD OF THE INVENTION
[0003] The present invention relates to procedures for relieving
problems associated with carpal tunnel syndrome and, more
particularly, to a procedure for performing a minimally invasive to
non-invasive surgical procedure on a transverse carpal
ligament.
BACKGROUND OF THE INVENTION
[0004] Carpal tunnel syndrome is a common problem that affects the
hand and wrist. This condition, or syndrome, has become the focus
of much attention in the last few years due to suggestions that it
may be linked to certain occupations that require repetitive use of
the hands, such as typing. While certain occupations may experience
more problems with carpal tunnel syndrome, many people develop this
condition regardless of their occupation.
[0005] Particularly, carpal tunnel syndrome (CTS) is a condition
that results when the median nerve of the hand does not function
properly. Usually, this occurs because there is too much pressure
on the median nerve that extends into the wrist through an opening
called the carpal tunnel. The median nerve extends into the hand to
receive sensation from the thumb, index finger, long finger, and
half of the ring finger. The median nerve also provides a branch to
the muscles of the thumb (i.e. the thenar muscles).
[0006] The carpal tunnel is an opening into the hand that is made
up of the bones of the wrist (i.e. the carpals) on the bottom and
the transverse carpal ligament on the top. The median nerve and the
flexor tendons extend through the carpal tunnel into the hand. The
median nerve lies just under the transverse carpal ligament (TCL).
A material called the tenosynovium covers the flexor tendons. The
tenosynovium is slippery and thus allows the tendons to glide
against each other as they move. Any condition that causes
irritation or inflammation of the tendons can result in swelling
and/or thickening of the tenosynovium. As the tenosynovium begins
to swell and/or thicken, pressure begins to increase in the carpal
tunnel. This is because the bones and ligaments that form the
carpel tunnel are fixed in size and thus are not able to stretch to
accommodate the swelling. Increased pressure in the carpel tunnel
begins to squeeze the median nerve against the transverse carpal
ligament, since the median nerve is the softest structure in the
carpal tunnel. Eventually, the pressure reaches a point where the
median nerve can no longer function normally. This manifests itself
as pain and numbness in the hand.
[0007] There are many conditions that can result in irritation and
inflammation of the tenosynovium, and eventually cause carpal
tunnel syndrome. Different types of arthritis can cause
inflammation of the tenosynovium directly. A fracture of the wrist
bones may later cause carpal tunnel syndrome if the healed
fragments result in abnormal irritation on the flexor tendons.
Particularly, anything that causes abnormal pressure on the median
nerve will result in the symptoms of carpal tunnel syndrome.
[0008] In the early stages of carpal tunnel syndrome, non-operative
treatments are typically used. One such non-operative treatment is
the use of a brace. The brace keeps the wrist in a neutral
position. When the wrist is in a neutral position, the carpal
tunnel is as large as it can be so the median nerve has as much
room as possible.
[0009] Another non-operative treatment that tries to reduce the
symptoms of carpal tunnel syndrome is the use of anti-inflammatory
medications to help control swelling of the tenosynovium.
Anti-inflammatory medications include over the counter medications
such as ibuprofen and aspirin, as well as high doses of vitamin
B-6. Injections of cortisone into the carpal tunnel may also be
used in order to decrease swelling of the tenosynovium and thereby
give temporary relief of symptoms.
[0010] If the non-operative treatments fail to control the symptoms
of carpal tunnel syndrome, surgery may be required to reduce the
pressure on the median nerve. There are essentially three surgical
techniques designed to relieve pressure on the median nerve. The
first and most common surgical procedure is the traditional open
incision technique. The second surgical procedure is known as the
mini-open. The third procedure is an endoscopic technique.
[0011] The traditional open incision technique requires a 2 to 21/2
inch incision to be made in the palm of the hand. A structure
called the palmer fascia is then incised in order to reach the
transverse carpal ligament. The transverse carpal ligament is then
cut while making sure that the median nerve is out of the way and
protected. The cut or incision may be slight (small incised amount)
or drastic (e.g. as in a full carpal tunnel release (CTR)
procedure). Pressure on the median nerve is relieved after cutting
of the transverse carpal ligament. The incised skin is then
sutured. The transverse carpal ligament remains open and the gap is
slowly filled by scar tissue.
[0012] Major drawbacks to the standard, open incision technique are
the slowness of recovery and the size of the resulting scar. Often
the 2 inch palm side scar remains sensitive to direct pressure for
approximately six to eight weeks. For a working patient, this scar
sensitivity may preclude return to normal work activities.
Generally, the greater the invasiveness of the remedial
methodology, the longer the recovery time is for the patient.
[0013] The mini-open technique utilizes a 1 to 11/2 cm incision
proximate the transverse carpal ligament. Various instruments are
placed through the incision and utilized to cut the TCL from
underneath as appropriate.
[0014] In the endoscopic carpal tunnel release technique, a small
horizontal incision is made at the wrist and an arthroscope is
introduced underneath the transverse carpal ligament. A small knife
or blade, attached to the end of the arthroscope, is utilized to
incise or cut the transverse carpal ligament. Again, cutting
through the transverse carpal ligament alleviates the compression
on the median nerve. While the endoscopic carpal tunnel release
technique is less invasive than the traditional, and is typically
accomplished on an outpatient basis, it is nonetheless an invasive
procedure that requires time to heal. Because the incision is not
retracted to provide an open view, a camera probe and light are
inserted through small openings placed in the arm or hand to
provide the surgeon with a view of the anatomical structure of the
surgical site. However, known endoscopic imaging methods may not
provide adequate visualization of the TCL and its surrounding
structure so some surgeons prefer an open incision technique.
[0015] Moreover, with current invasive techniques, the surgeon must
rely on his/her own expertise for determining, not only the
location and orientation of the initial incision on the palm of the
hand, but also in deciding where the transverse carpel ligament
should be dissected. The place of dissection is critical because
while it is desired to split the transverse carpal ligament, the
surgeon must not lacerate any major branch of the median or ulnar
nerves.
[0016] Although current complication rates are low (approximately
3-4%), inadvertent laceration of a nerve (either fully or
partially) can have catastrophic effects on the functionality of
the patient's hand. The risk of hand impairment may cause patients
suffering from carpal tunnel syndrome to forego surgical remedies
of the malady.
[0017] In view of the above, a therapeutic technique for performing
carpal tunnel release that reduces the risk of median or ulnar
nerve laceration is desirable.
[0018] Methodologies for encouraging endoscopic procedures are
needed to reduce the trauma and recovery time associated with more
invasive surgical procedures.
SUMMARY OF THE INVENTION
[0019] The subject invention is a system, method and/or apparatus
for facilitating minimally invasive to non-invasive surgical
treatment of carpal tunnel syndrome. Particularly, the subject
invention is a system, method and/or apparatus for performing a
minimally invasive to non-invasive transverse carpal ligament
treatment procedure.
[0020] According to an aspect of the subject invention,
three-dimensional imaging of the structures and/or features of a
patient's wrist, particularly the internal tissue and/or bone
structure(s) of the wrist, is obtained to more accurately identify
a target area for dissection of the transverse carpal ligament. The
three-dimensional images are stored and evaluated to accurately
target therapeutic treatment for and/or on the transverse carpal
ligament particularly, but not exclusively, for performing a carpal
tunnel release. The three dimensional images are particularly
useful for assisting endoscopic surgeons in understanding the
images presented by the endoscopic camera located within the
patient's hand or wrist so they may safely maneuver instruments
within a patient's hand with lower risk of injury or trauma to the
internal tissue of the hand.
[0021] The imaging methodologies of the present invention also
enable a treating physician to more effectively perform
non-invasive techniques in accordance with another aspect of the
subject invention. The imaging and/or treatment protocols of the
present invention may be performed in a non-invasive manner (i.e.
without an incision), in a minimally invasive manner (i.e. with a
small incision), or even in a fully invasive manner (i.e. with a
small to large incision); however, the non-invasive or minimally
invasive manners are preferred. The three dimensional imaging
methodologies used in the present invention are real time imaging
methods, such as spatial compounding ultrasound imaging, computed
tomography (CT) imaging, and magnetic resonance imaging (MRI), or
the like.
[0022] In one form, the three-dimensional imaging locates the
transverse carpal ligament particularly with respect to or
additionally with the median nerve and/or its branches, carpals,
carpal tunnel and/or the like in a patient's hand through the use
of ultrasound, preferably, but not necessarily, high frequency
ultrasound typically in the 7.5-30 MHz range. The location of the
transverse carpal ligament is utilized for commencement of surgical
treatment of the transverse carpal ligament ranging from a full
carpal tunnel release to a mere cutting or necrosis of a portion of
the TCL as well as stretching or relaxing a portion or all of the
TCL.
[0023] According to another aspect of the subject invention, a
surgical procedure on the transverse carpal ligament treats the
selected target area or an area near the selected target area. The
treatment may include heating the selected target area of the TCL
to cause elongation or stretching of the target area(s) of the
transverse carpal ligament, or necrosis, ablation and/or dissection
of the area(s) of the transverse carpal ligament. The treatment of
the selected target area during a surgical procedure may be
performed by directly applying ultrasound waves to the target area
in the frequency range of about 20 KHz to about 100 KHz.
[0024] In one particular form, the subject invention provides a
method of performing treatment on a transverse carpal ligament of a
wrist of a patient. The method includes the steps of: (a) locating
the transverse carpal ligament relative to internal structures
proximate the transverse carpal ligament with real time three
dimensional images; (b) determining a plan of treatment for a
selected target area on the located transverse carpal ligament; and
(c) treating the selected target area of the transverse carpal
ligament in accordance with the determined plan of treatment.
[0025] In another particular form, the subject invention provides a
system for performing treatment of the transverse carpal ligament.
The system includes: (a) an imager for obtaining a
three-dimensional image of a transverse carpal ligament of a wrist
of a patient relative to internal structures of the wrist proximate
the transverse carpal ligament; (b) a signal generator for
generating treatment signals at a selected target tissue area; and
(c) an applicator in communication with the generator to apply the
generated signals to the selected target tissue area according to
the obtained three-dimensional image.
[0026] One treatment method performed in accordance with the
principles of the present invention includes identifying a target
area for an ultrasound treatment and applying ultrasound waves to
the target area. The transducer head used to generate and apply the
ultrasound waves to the target area may be placed against the
patient's skin proximate the TCL or incorporated in a surgical
probe having one or more ultrasonic transducers that may be applied
to the target area during an endoscopic procedure. The ultrasonic
treatment of a patient's TCL may include radiating the TCL with
ultrasonic waves in the frequency range of about 20 KHz to about
100 KHz when done during an surgical procedure, including
endoscopic procedures, and from about 100 KHz to about 50 MHz for
noninvasive therapies. Thus, the frequency range of ultrasound
waves used to treat a patient's TCL is wider than the range of
imaging ultrasound waves. Additionally, the target area of the TCL
may be radiated with more than one frequency of ultrasound waves,
either substantially at the same time or sequentially. The duration
of the periods of application for the ultrasound treatment waves
may be the same or different for the various frequencies used in
the treatment. Also, the ultrasound waves may be applied in a
variety of field patterns, including, but not limited to, circular
spot, ellipsoid spot, and rectangular spot and one or more
application patterns may be used during application of a
treatment.
[0027] The ultrasound treatment methodology of the present
invention may also include monitoring the effects of the ultrasound
bombardment of the target area. This monitoring may include
determining the degree of acoustic speed through the target tissue,
the attenuation of acoustic energy by the target tissue, the change
in density in the target tissue, the temperature of the target
tissue, or the non-linearity of the target tissue's response to the
ultrasound waves. These monitored effects may be used to select one
or more frequencies for the treatment, application durations for
ultrasound waves, or other treatment parameters.
[0028] Another method that may be performed in accordance with the
principles of the present invention includes administering drug
therapy to the target site and applying ultrasound waves to the
target site to enhance the effectiveness of the drug therapy. The
administered drugs include local anti-inflammatory medicines, local
analgesic medications, and steroid-based anti-inflammatory
compounds. These ultrasound treatments enhance the shrinking or
inflammation reduction effects of these drugs at the target area.
Local anti-inflammatory drugs include ibuprofen and the like, local
analgesic medicines include aspirin, and steroid-based
anti-inflammatory medications include hydrocortisone or the
like.
[0029] The subject invention provides the benefits of: i) a
minimally invasive to non-invasive, bloodless and relatively
painless surgical procedure; ii) a greater degree of visualization
to assist a surgeon in the maneuvering of instruments within a
patient's hand; and iii) a decrease in risk of injury or recovery
time to patients.
BRIEF DESCRIPTION OF THE DRAWINGS
[0030] In the drawings:
[0031] FIG. 1 is a block diagram of a non-invasive treatment system
for carpal tunnel problems in accordance with the principles of the
subject invention;
[0032] FIG. 2 is a block diagram of an exemplary embodiment of an
imaging and treatment portion of the non-invasive treatment system
of FIG. 1;
[0033] FIG. 3 is a block diagram of another exemplary embodiment of
an imaging and treatment portion of the non-invasive treatment
system of FIG. 1;
[0034] FIG. 4 is a perspective view of an exemplary configuration
of a combined probe/applicator for imaging a transverse carpal
ligament and surrounding structures of the wrist and/or treatment
thereof in accordance with the present principles;
[0035] FIG. 5 is a perspective view of another exemplary
configuration of a combined probe/applicator for imaging a
transverse carpal ligament and surrounding structures of the wrist
and/or treatment thereof in accordance with the present
principles;
[0036] FIG. 6 is a perspective view of yet another exemplary
configuration of a combined probe/applicator for imaging a
transverse carpal ligament and surrounding structures of the wrist
and/or treatment thereof in accordance with the present
principles;
[0037] FIG. 7 is a perspective view of still another exemplary
configuration of a combined probe/applicator for imaging a
transverse carpal ligament and surrounding structures of the wrist
and/or treatment thereof in accordance with the present
principles;
[0038] FIG. 8 is an illustration of an imaged wrist of a hand of a
patient receiving treatment in accordance with the present
principles;
[0039] FIG. 9 is a flowchart of an exemplary carpal tunnel release
procedure in accordance with the present principles;
[0040] FIG. 9A is a flowchart of an exemplary manner of carrying
out a step of the flowchart of FIG. 9;
[0041] FIG. 9B is a flowchart of an exemplary manner of carrying
out another step of the flowchart of FIG. 9;
[0042] FIG. 10 is an illustration of various transducer
arrangements that may be used to implement the principles of the
present invention;
[0043] FIG. 11 is a flowchart of an example of a method for
treating a patient in accordance with the principles of the present
invention; and
[0044] FIG. 12 is a block diagram for a system that may be used to
treat a patient's hand with multiple sound frequencies; and
[0045] FIG. 13 is an illustration of a surgical probe that may be
used to apply a treating sound frequency to a selected target area
in accordance with the principles of the present invention.
[0046] Corresponding reference characters indicate corresponding
parts throughout the several views. Like reference characters tend
to indicate like parts throughout the several views.
DETAILED DESCRIPTION OF THE INVENTION
[0047] While the invention is susceptible to various modifications
and alternative forms, specific embodiments thereof have been shown
by way of example in the drawings and will herein be described in
detail. It should be understood, however, that there is no intent
to limit the invention to the particular forms disclosed, but on
the contrary, the intention is to cover all modifications,
equivalents, and alternatives falling within the spirit and scope
of the invention.
[0048] Referring now to FIG. 1 there is shown a block diagram of an
exemplary system, generally designated 10, for three-dimensional
(3-D) imaging of a transverse carpal ligament of a wrist of a hand
and providing treatment (preferably, but not necessarily in a
non-invasive manner) to the wrist area of a patient, particularly
the transverse carpal ligament such as for relieving carpal tunnel
syndrome and/or its symptoms. The system 10 provides for the
three-dimensional imaging and the recording of the location of at
least the transverse carpal ligament and preferably, the transverse
carpal ligament and surrounding structures or features of a
patient's wrist. The system 10 also provides for treatment to the
transverse carpal ligament that is preferably, but not necessarily,
based on the 3-D imaging thereof. The treatment ranges from
stretching or elongation of a target area or target areas of the
transverse carpal ligament to complete tissue ablation, necrosis
and/or dissection of the transverse carpel ligament at the target
area.
[0049] The system 10 produces a therapeutic condition, such as an
elevated temperature condition, at a target area of a particular
tissue or tissue type. This may be accomplished in a non-invasive
manner or in a minimally invasive manner. It should be appreciated
that while the subject invention is applicable for use in both
non-invasive and minimally invasive manners, the subject invention
is preferably used in a non-invasive manner. Therefore while
hereinafter the term non-invasive is used with respect to the
subject invention, invasive manners are covered as well. The
therapeutic condition is produced by energy waves particularly
pressure waves, such as ultrasound. The pressure wave may be shaped
as appropriate for the target area.
[0050] The system 10 may be used for performing a non-invasive
carpal tunnel release procedure on the target area(s) of the
transverse carpal ligament, typically for alleviating problems
and/or symptoms associated with carpal tunnel syndrome, or a lesser
procedure on the transverse carpal ligament. In this manner, the
pressure within the carpal tunnel or canal is relieved in a
bloodless, efficient and accurate manner. It should be appreciated
that while the system will be described with respect to the
transverse carpal ligament and/or wrist area, particularly for
carpal tunnel release, the subject invention may be used for other
tissue types and/or tissue areas.
[0051] The system 10 includes a computer, processing device, or
other similar device 12 such as is known in the art. The computer
12 has a storage device 25, such as a hard drive, that stores
program instructions 26 for the operation of the computer and for
the operation, features and/or functionality of the subject
invention as well as the functionality of the various components of
the computer 12 and the various components of the system 10 as
herein provided. As discussed below, the storage device 25 also
stores still images and video (images) 28 as acquired and includes
3-D modeling and imaging software, treatment software, diagnostic
software, interface software, and the like. The storage device 25
is operative to store, receive and allow deletion therefrom of
various types of data. Memory 24 is also provided such as RAM for
temporarily storing data and program instructions for execution
and/or ROM for permanently storing data such as is known in the
art.
[0052] A user input device such as a keyboard and/or mouse 20 is
operatively connected to the computer 12. The user input device 20
is operative to accept or receive input from a user for operation
of the subject invention. A display 18 is also coupled or connected
to the computer 12 and is adapted to display images/video
(including program interfaces, e.g. GUIs) thereon as received from
the computer 12. Optionally, a printer 22 is operatively coupled or
connected to the computer 12. If provided, the printer 22 is
preferably a high resolution printer. The printer 22 is adapted to
receive and print images, text and/or the like as necessary.
[0053] The computer 12 also includes a processor and/or processing
circuitry/logic 30 that is operative, adapted and/or configured to
utilize the program instructions 26 and/or control the various
components of the computer 12 and/or the system 10. Other
components of the computer 12 not described herein but which are
typically part of a computer such as communication hardware,
display adaptors, and/or the like are represented by the other
components box 32.
[0054] In accordance with an aspect of the subject invention, the
system includes an imaging and treatment portion, section,
sub-system, or the like, generally designated 13. The imaging and
treatment portion 13 may be separate from the computer 12 or may be
at least partially integral with the computer 12 as represented by
the dashed lines. In either case, the functioning is the same. The
imaging and treatment portion 13 is configured, adapted and/or
operative to perform three-dimensional tissue imaging, both static
and dynamic, such as a transverse carpal ligament and surrounding
structures/features, and provide treatment to a target area of the
imaged tissue. The imaging and treatment portion also obtains data
that is formed into the three-dimensional image. The obtained image
is preferably stored in the images section 28 of the storage device
25.
[0055] Particularly, the imaging and treatment portion 13 includes
a three-dimensional imaging system 14 and a tissue (transverse
carpal ligament) treatment system 16. The imaging portion 14
obtains tissue images while the treatment/application portion 16
provides a non-invasive procedure that induces, generates, creates
or produces an elevated temperature condition at the target tissue
area preferably, but not necessarily, in accordance with the
imaging, and at least with respect to a determined plan of
treatment typically selected with regard to the imaging. The
elevated temperature condition is localized heating of the target
tissue area to a point where the target tissue is stretched or
elongated, tissue ablation occurs at the target tissue area, tissue
necrosis, tissue dissection, or other appropriate treatment effect
on the tissue. The system 13 can provide intervals of imaging and
treatment until a desired outcome is produced.
[0056] In FIG. 2 there is depicted a block diagram of an exemplary
embodiment of the imaging and treatment portion 13 of the
non-invasive diagnostic and treatment system 10 of FIG. 1. The
imaging portion 14 is shown as including an ultrasound imager 80
and a probe 81 connected thereto. The treatment portion 16 is shown
as including an ultrasound generator 82 and an applicator 83
connected thereto. It should be appreciated, however, that other
imaging systems or imagers may be used such as MRIs, CAT scans,
and/or the like.
[0057] The imaging portion 14 is operatively coupled or connected
to the computer 12. The ultrasound imager 80 is configured, adapted
and/or operative to cause the production or generation of
ultrasound waves at a particular ultrasound frequency or at one or
more of a plurality of ultrasound frequencies. The ultrasound
imager 80 preferably is operative to controllably cause the
production or generation of ultrasound in a frequency range of
about 1.0 MHz to 35 MHz. Typically, low frequency ultrasound in the
1.0 to 7.5 MHz range is used for diagnostics/imaging and ultrasound
in the frequency range of about 20 KHz to about 50 MHz may be used
for treatment as described herein.
[0058] An ultrasound probe 81 is operatively coupled or connected
to the ultrasound imager 80. The probe 81 is adapted, configured
and/or operative to produce, generate and/or emit the ultrasound
waves in accordance with the ultrasound imager 80. The probe 81
thus serves as a source for ultrasound waves or signals used for
imaging. The probe 81 is also adapted, configured and/or operative
to receive the ultrasound signals/waves that are reflected from or
echo off of the internal wrist structures (tissues) and convert the
received reflected ultrasound signals/waves into electrical
signals. The received ultrasound signals/waves, being converted
into electrical signals, are received by the ultrasound imager 80
to produce a reflected pattern. The reflected pattern is utilized
by appropriate program instructions 26 to produce an image.
[0059] The probe 81 may be moved to provide three-dimensional
imaging of the internal wrist structures including the transverse
carpal ligament and location with respect to the other internal
wrist structures. The probe 81 may be designed to be situated about
the wrist such that various angles of ultrasound signals are
produced and reflections received that provide a three-dimensional
image of the wrist structures, particularly the transverse carpal
ligament, carpal tunnel, and other adjacent structures. These
images may be displayed for educating a treating physician
regarding the structure of an area to be treated, for assisting a
treating physician in visualizing what the physician is viewing
during an endoscopic procedure, and/or for enabling a treating
physician to select a target area for therapeutic treatment.
[0060] While the ultrasound imager 80 is shown as a separate
component, it should be appreciated that part or all of the
ultrasound imager and/or its functionality may be incorporated into
or as part of the computer 12 and/or its various components. In
this case, the probe 81 may be directly coupled to the computer
12.
[0061] The treatment portion 16 is operatively coupled or connected
to the computer 12. The treatment portion 16 is configured, adapted
and/or operative to cause the production or generation of
ultrasound waves or signals capable of providing therapeutic
treatment of internal tissue at a target area. The treatment
portion 16 includes an ultrasound generator 82 capable of providing
ultrasound waves for therapeutic treatment of the tissue target
area. An applicator 83 is operatively coupled or connected to the
ultrasound generator 82. The applicator 83 is adapted, configured
and/or operative to produce, generate and/or emit the ultrasound
waves in accordance with the ultrasound generator 82. The
applicator 83 thus serves as a source for the treatment ultrasound
waves or signals.
[0062] The applicator 83 may be moved to provide treatment to a
specific target area or target areas (collectively, target area) of
the particular tissue undergoing treatment. The applicator 83 may
be designed to be situated about the wrist such that various angles
of ultrasound treatment signals are produced, particularly for
treatment of the transverse carpal ligament.
[0063] While the ultrasound generator 82 is shown as a separate
component, it should be appreciated that part or all of the
ultrasound generator and/or its functionality may be incorporated
into or as part of the computer 12 and/or its various components.
In this case, the applicator 83 may be directly coupled to the
computer 12.
[0064] Referring to FIG. 3, there is depicted a block diagram of
another exemplary embodiment of the imaging and treatment portion
13. In this embodiment, a combined ultrasound imager and generator
84 substitute for the separate ultrasound imager 14 and the
ultrasound generator 82 of FIG. 2. The combined ultrasound
imager/generator 84 is configured, operative and/or adapted to
perform in the same manner as described above for the separate
components. Moreover, the imaging and treatment portion 13 includes
a combined probe/applicator 85 that likewise, combines the
functionality of the probe 81 and applicator 83 of FIG. 2 into a
single unit.
[0065] It should be appreciated that while the ultrasound
imager/generator 84 is shown as a separate component, part or all
of the ultrasound imager/generator and/or its functionality may be
incorporated into or as part of the computer 12 and/or its various
components. In this case, the probe/applicator 85 may be directly
coupled to the computer 12.
[0066] Referring now to FIG. 4, there is depicted an exemplary
embodiment of a probe and/or treatment/applicator device generally
designated 34. The probe/treatment (or probe/applicator) device 34
is an exemplary embodiment of one of the probe 81, the applicator
83, or the combined probe/applicator 85 (collectively hereinafter,
probe/applicator device). The probe/applicator device 34 is
operative, adapted and/or configured to produce and emit ultrasound
waves and receive reflected ultrasound waves. The probe/applicator
device 34 has a body or shell 36 that is formed as an essentially
large diameter, small (axial) length cylinder having an essentially
round head 37. The head 37 is utilized to abut or be in contact
with the skin, typically via a transmission jelly such as in known
in the art. As such, the head 37 is shaped accordingly to take into
account the typical shape of a wrist.
[0067] The body 36 houses a transducer 38 such as a piezoelectric
crystal. The transducer 38 is operative to produce and emit
ultrasound waves of the appropriate frequency and receive (capture)
reflected ultrasound waves. The transducer 38 converts the captured
ultrasound waves into electrical signals that are transmitted via
conductor 40 to the ultrasound imaging device/generator 14 and/or
the computer 12.
[0068] While depicted as a single device, the transducer 38 may be
two separate devices. One device would be the ultrasound source,
while the other device would be the ultrasound receiver. The source
device may constitute a single transducer or an array of
transducers for three-dimensional imaging. The receiver device
likewise may be a single transducer of an array of transducers.
Moreover, the housing 36 is sized to be positioned over and/or
around the wrist of a patient.
[0069] Referring now to FIG. 5, there is depicted another exemplary
embodiment of a probe and/or treatment/applicator device generally
designated 44. The probe/treatment (or probe/applicator) device 44
is an exemplary embodiment of one of the probe 81, the applicator
83, or the combined probe/applicator 85 (collectively hereinafter,
probe/applicator device). The probe/applicator device 44 is
operative, adapted and/or configured to produce and emit ultrasound
waves and receive reflected ultrasound waves. The probe/applicator
device 44 has a body or shell 46 that is formed as an essentially
small diameter, large (axial) length cylinder having an essentially
round head 47. The head 47 is utilized to abut or be in contact
with the skin, typically via a transmission jelly such as in known
in the art. As such, the head 47 is shaped accordingly to take into
account the typical shape of a wrist.
[0070] The body 46 houses a transducer 48 such as a piezoelectric
crystal. The transducer 48 is operative to produce and emit
ultrasound waves of the appropriate frequency and receive (capture)
reflected ultrasound waves. The transducer 48 converts the captured
ultrasound waves into electrical signals that are transmitted via
conductor 50 to the ultrasound imaging device/generator 14 and/or
the computer 12.
[0071] While depicted as a single device, the transducer 48 may be
two separate devices. One device would be the ultrasound source,
while the other device would be the ultrasound receiver. The source
device may constitute a single transducer or an array of
transducers for three-dimensional imaging. The receiver device
likewise may be a single transducer of an array of transducers.
Moreover, the housing 46 is sized to be positioned over and/or
around the wrist of a patient.
[0072] Referring now to FIG. 6, there is depicted yet another
exemplary embodiment of a probe and/or treatment/applicator device
generally designated 54. The probe/treatment (or probe/applicator)
device 54 is an exemplary embodiment of one of the probe 81, the
applicator 83, or the combined probe/applicator 85 (collectively
hereinafter, probe/applicator device). The probe/applicator device
54 is operative, adapted and/or configured to produce and emit
ultrasound waves and receive reflected ultrasound waves. The
probe/applicator device 54 has a body or shell 56 that is formed as
an elongated wand. The wand 56 has a transmission/reception area 57
that is shaped to contact the wrist area of the hand of the
patient.
[0073] The body 56 houses a transducer 58 such as a piezoelectric
crystal. The transducer 58 is operative to produce and emit
ultrasound waves of the appropriate frequency and receive (capture)
reflected ultrasound waves. The transducer 58 converts the captured
ultrasound waves into electrical signals that are transmitted via
conductor 50 to the ultrasound imaging device/generator 14 and/or
the computer 12.
[0074] While depicted as a single device, the transducer 58 may be
two separate devices. One device would be the ultrasound source,
while the other device would be the ultrasound receiver. The source
device may constitute a single transducer or an array of
transducers for three-dimensional imaging. The receiver device
likewise may be a single transducer of an array of transducers.
[0075] Referring now to FIG. 7, there is depicted another exemplary
embodiment of a probe and/or treatment/applicator device generally
designated 64. The probe/treatment (or probe/applicator) device 64
is an exemplary embodiment of one of the probe 81, the applicator
83, or the combined probe/applicator 85 (collectively hereinafter,
probe/applicator device). The probe/applicator device 64 is
operative, adapted and/or configured to produce and emit ultrasound
waves and receive reflected ultrasound waves. The probe/applicator
device 64 has a body or shell 66 that is formed as an essentially
large diameter, small (axial) length cylinder having an essentially
oval and/or curved head 67. The head 67 is utilized to abut or be
in contact with the skin and be around at least 180.degree. around
the wrist, typically via a transmission jelly such as in known in
the art. As such, the head 67 is shaped accordingly to take into
account the typical shape of a wrist.
[0076] The body 66 houses a transducer 68 such as a piezoelectric
crystal. The transducer 68 is operative to produce and emit
ultrasound waves of the appropriate frequency and receive (capture)
reflected ultrasound waves. The transducer 68 converts the captured
ultrasound waves into electrical signals that are transmitted via
conductor 60 to the ultrasound imaging device/generator 14 and/or
the computer 12.
[0077] While depicted as a single device, the transducer 68 may be
two separate devices. One device would be the ultrasound source,
while the other device would be the ultrasound receiver. The source
device may constitute a single transducer or an array of
transducers for three-dimensional imaging. The receiver device
likewise may be a single transducer of an array of transducers.
Moreover, the housing 66 is sized to be positioned over and/or
around the wrist of a patient.
[0078] In FIG. 8, there is depicted a hand 72 of a patient in order
to illustrate an exemplary manner of utilizing the system 10 and of
an exemplary manner of performing a non-intrusive carpal tunnel
release. The wrist area 74 of the hand 72 has been imaged in 3-D,
particularly the transverse carpal ligament 76, by a combined
probe/applicator 85. The transverse carpal ligament 76 is shown in
relation to the median nerve 78. The 3-D imaging is preferably
stored and used in determining an appropriate treatment for the
transverse carpal ligament 76. The transverse carpal ligament 76 is
also located with respect to other features or structures of the
wrist 74 that are not shown.
[0079] The probe/applicator 84 is providing preferably
high-frequency ultrasound treatment to a selected or particular
target area or areas of the transverse carpal ligament. Depending
on the frequency and/or length of time of exposure, the target area
tissue will be elongated (stretched), ablated, dissected, or be
subject to necrosis. Of course, other probe shapes may be
utilized.
[0080] Referring now to FIG. 9, there is depicted a flowchart,
generally designated 90, of an exemplary manner of performing a
non-intrusive carpal ligament release in accordance with the
present principles and preferably, but not necessarily, using the
present system 10. In step or block 92, a three-dimensional image
of a transverse carpal ligament and other internal wrist structures
is obtained. In step 94, the obtained three-dimensional image is
stored. In step 96, the stored three-dimensional image is utilized
to provide a non-invasive carpal tunnel release (CTR) procedure.
The procedure of step 96 may entail a complete treatment, or may
entail a partial treatment. For a partial treatment, after a first
treatment, the transverse carpal ligament may be re-imaged and
treatment is repeated. The repeated treatment may be to the same
target area or to a different target area.
[0081] In FIG. 9A, an expanded flowchart of step 92 is shown. It
should be appreciated that the expanded flowchart of step 92 is
only exemplary of a manner of executing step 92. In step 100, an
ultrasound transducer is placed on the wrist of a patient. In step
102, ultrasound signals are generated that are transmitted into the
wrist area. In step 104, ultrasound signals that are reflected by
the underlying tissue/tissue structures (including the transverse
carpal ligament and the median nerve) are received by the probe.
The signals, in step 106, are processed to obtain a
three-dimensional image of the transverse carpal ligament and its
relationship to the other structures of the wrist. Optionally, in
step 108, the generated three-dimensional image is displayed.
[0082] In FIG. 9B, an expanded flowchart of step 96 is shown. It
should be appreciated that the expanded flowchart of step 96 is
only exemplary of a manner of executing step 96. In step 120, an
ultrasound transducer (applicator) is strategically placed on the
wrist to be imaged. In step 122, high frequency ultrasound signals
are generated and directed at a particular location (target area)
of the transverse carpal ligament. In step 124, the target location
of the transverse carpal ligament is heated by the ultrasound
signals to provide elongation, ablation, necrosis and/or dissection
as appropriate.
[0083] The principles of the present invention may be implemented
with an HDI 5000 ultrasound imaging system that is available from
Philips Medical Systems Company, of Bothell, Wash. Such a system
uses different lines of sight for the radiation used to image an
area to provide three dimensional images. A representative method
of generating ultrasound images is sometimes called spatial
compounding. This type of imaging may be achieved with various
shapes of ultrasound probes, such as the ones shown in FIG. 10. The
transducer arrays in these probes may be described as linear,
curved, or tightly curved arrays. The transducers that may be used
in this type of imaging include broadband curved, linear and phased
array transducers. The imaging system 14 of the present invention
may also be implemented with computed tomography (CT) images that
may be obtained from known CT scanners.
[0084] The three dimensional images obtained of the carpal tunnel
area enable a treating physician to more accurately identify a
target area for treatment. As described above, these images may be
stored and displayed for various purposes. For one, they may be
used to educate a treating physician regarding the form and
location of soft tissue structure. For another, they may be
displayed during the performance of an endoscopic procedure to aid
a surgeon in the understanding the images provided by an endoscopic
camera. The images may also be displayed so a surgeon or other
treating physician may select a target area that is sufficiently
removed from the median or ulnar nerve that the risk of severing
the nerve is substantially reduced.
[0085] An ultrasound imaging system may be modified to provide a
tissue treatment system 16 that generates ultrasound signals in the
range of approximately 1 MHz to approximately 35 MHz. Depending on
the type of transducer probe used, the acoustic energy from the
probe may be focused on a small target area or spread over a
broader target area. For example, the linear and curved transducer
arrays of FIG. 10 cover wider areas than the more focused field
that emanates from the tightly curved transducers of the tightly
curved probe.
[0086] In an implementation of the present invention, the computer
12 is programmed with instructions for controlling the operation of
the treatment system 16. Under the control of the instructions, the
computer 12 obtains images of a tissue structure and displays them
for a treating physician (block 130). Using the displayed images, a
treating physician selects a target area (block 132). If a
frequency wave treatment is to be performed, the program enables a
user to define one or more frequencies to be used during frequency
wave treatment (block 134). The user also specifies a time for the
application of each frequency (block 134), although default time
periods may be used for application of ultrasound frequencies. The
defined treatment protocol may then be stored in the system (block
138). Once the patient has been prepared for the treatment, the
ultrasound probe of treatment 16 may be placed in contact with the
patient's skin with a transmission jelly as is well known. The
stored treatment protocol may then be activated (block 140) and
retrieved for execution (block 144). In response to the stored
protocol, the computer 12 communicates with the treatment system 16
to identify a frequency for generation of ultrasound waves (block
148) and to set the timer for application of the signal (block
150). System 16 drives the ultrasound wave generators at the
identified frequency to apply the treating waves to the target area
(block 154). The transducers of the probe may be arranged in a
number of configurations that produce different field shapes at the
target area. These field shapes include circular spot, ellipsoid,
or rectangular spot field shapes. When the treatment system 16
indicates that it is applying the identified frequency to the
probe, computer 12 determines when the application period expires
(block 158) and sends a signal to the treatment system 16 to
terminate generation of the identified frequency (block 160). Of
course, the computer 12 may also provide the application timing
parameter to the treatment system 16 so that the system 16
determines when to terminate application of the ultrasound waves.
Computer 12 determines whether another ultrasound signal is to be
applied (block 164) and the process continues until all the
identified frequencies have been applied to the target area (blocks
148-160). Execution of the protocol is then terminated (block
168).
[0087] The imaging system 14 may be used to evaluate the results of
the treatment protocol. Specifically, the imaging system may be an
ultrasound system, such as the HDI 5000 system noted above, that is
used to image the target area after the treatment protocol has been
performed. Parameters such as the density of the target area, the
speed of the ultrasound waves in the target area, the attenuation
of the ultrasound signals by the target area, and the linearity of
the target area's response to the ultrasound signals may be used to
determine the results of the treatment protocol. The user selects
one or more parameters and the computer 12 sends messages to
imaging system 14 to measure the selected parameters. The
measurements are returned to the computer 12 for display or the
measurements may be displayed at the imaging system 14. If the
measurements indicate that the target area tissue has responded
satisfactorily to the protocol, the treatment is concluded.
Otherwise, the physician may define a new protocol for a second
treatment or the physician may decide to apply the stored protocol
a second time. Other options may also include the performance of
conventional treatment protocols.
[0088] A modification to the treatment system 16 that uses a stored
protocol is the definition of the treatment protocol. As shown in
FIG. 12, the treatment system 16 may include multiple transducer
array banks 180, each of which may be coupled to an ultrasound
signal generator 184 and a controller 188. The controller 188
receives treatment parameter data from the computer 12 for
controlling the operation of the treatment system 16. The computer
12 may be programmed to enable a user to define multiple ultrasound
frequencies for application to the target area at the same time. In
response to the receipt of multiple frequencies for the generation
of ultrasound waves during the same application period, the
controller 188 provides each ultrasound generator 184 with a
frequency value. Each ultrasound generator 184 then drives the
transducer or transducers coupled to the generator at that
frequency. The controller 188 may then determine when the
application period expires for a particular frequency and
deactivate the corresponding ultrasound generator 184.
Alternatively, the controller 188 may deactivate an ultrasound
generator 184 in response to a signal received from the computer 12
for termination of a particular ultrasound frequency. This
implementation of the present invention enables a treating
physician to identify multiple ultrasound frequencies for
simultaneous or overlapping application to the target area.
[0089] Another implementation of a system incorporating the
principles of the present invention enables a user to define a
change or absolute value for a particular parameter associated with
the target area for evaluation of a treatment protocol as it is
occurring. In this system, a user selects a parameter associated
with the target area, such as acoustic speed, density, linearity,
or filtering. The user may then define a change parameter, such as
a percentage change, statistical level, or the like. The imaging
system 14 then images the target area by generating ultrasonic
waves and measuring the selected parameter or parameters to form a
baseline for the parameters or parameters. For example, the speed
of a wave of one or more particular frequencies through the target
area may be measured and stored. Filtering may be measured by
determining the power of the reflected signal to determine the
amount of signal attenuation occurring through the target area.
Then, as the protocol is executed, the parameter is measured and
the change in the parameter with respect to the baseline is
computed. When the measured change is approximately the same as the
user defined change parameter, the computer 12 sends a signal to
the treating system 16 to terminate the application of the
ultrasound waves. The treating physician may then review the images
generated by the imaging system 14 for further evaluation of the
protocol's effectiveness. If absolute values are defined by the
user, the selected parameter or parameters are measured during the
treatment and the computer 12 sends a signal to terminate the
treatment in response to the measured parameter being approximately
the same as the user defined absolute value.
[0090] The system of the present invention may be used in a variety
of ways to enhance existing treatment protocols. For example, drug
treatment may be enhanced by having a patient ingest a medication,
such as an analgesic or anti-inflammatory drug, and then wait for
an appropriate period for the drug to available in the patient's
bloodstream at the target area. A treatment protocol of ultrasonic
radiation may occur to heat the target area and enhance the effect
of the medication on the target area. Alternatively, one or more
anti-inflammatory medications may be injected into or proximate the
target area so that the drug is available for uptake into the
target area. A treatment protocol of ultrasonic radiation may be
performed to heat the target area and enhance the effect of the
medication on the target area. Application of drug therapy in
conjunction an ultrasonic therapy protocol may also be applied
during an endoscopic procedure. Such a combination may be effective
for preparing the target area tissue for surgical treatment.
Alternatively, endoscopic techniques may be used to make the target
area available for bringing an ultrasonic probe into closer
proximity to the target area so that the ultrasonic waves may be
more directly focused on the target area. An example of a surgical
ultrasonic probe 200 is shown in FIG. 13. As shown in the figure,
the body 204 is coupled to an energy source through a cable 208.
The head 210 of the probe houses only one or a few transducers and
an adjustment knob 214 may be used to adjust the therapy waves
applied by probe 200. This arrangement is still effective because
the signals from the probe are not attenuated by the subcutaneous
layers that are interposed between the probes of FIG. 10 and the
target area when the probe is applied to the epidermis of the
patient.
[0091] While the systems and methods of the present invention have
been discussed as using ultrasonic radiation for treatment
protocols, other frequencies could be used as well. For example,
the imaging system 14 has been described as using ultrasonic and CT
imaging techniques, but MRI, and other known imaging techniques may
be used, either alone or in conjunction with the described imaging
techniques, to identify a target area and to evaluate its
parameters as explained above.
[0092] There are numerous advantages of the subject invention
arising from the various features of the subject invention
described herein. It will be noted that further alternative
embodiments of the subject invention may not include all of the
features described yet still benefit from at least some of the
advantages of such features. Those of ordinary skill in the art may
readily devise their own implementations of the subject invention
that incorporate one or more of the features of the subject
invention and that fall within the sprit and scope of the subject
invention.
* * * * *