Note: Descriptions are shown in the official language in which they were submitted.
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UTERINE ARTERY OCCLUSION CLAMP
FIELD OF THE INVENTION
[0001] The invention is generally directed to the treatment of uterine
disorders by
detecting and regulating blood flow through one or both of the patient's
uterine
arteries.
BACKGROUND OF THE INVENTION
[00021 Hysterectomy (surgical removal of the uterus) is performed on
approximately 600,000 women annually in the United States. Hysterectomy is
often
the therapeutic choice for the treatment of uterine cancer, adenomyosis,
menorrhagia, prolapse, dysfunctional uterine bleeding (abnormal menstrual
bleeding
that has no discrete anatomic explanation such as a tumor or growth), and
muscular
tumors of the uterus, known as leimyoma or uterine fibroids.
[0003] However, hysterectomy Is a drastic treatment, having many undesirable
characteristics. Thus, any method which can approximate the therapeutic result
of a
hysterectomy without removing the uterus would be a significant improvement in
this
field. Newer treatment methods have been developed for some diseases which may
spare these women a hysterectomy.
[0004] In 1995, it was demonstrated that uterine fibroids could be treated
without
hysterectomy using a non-surgical therapy, specifically comprising bilateral
intraluminal occlusion of the uterine arteries (Ravina at al., "Arterial
Embolization to
Treat Uterine Myomata", Lancet Sept. 9, 1995; Vol. 346; pp. 671-672
). This technique is known as "uterine artery embolization". In
this technique, uterine arteries are accessed via a transvascular route from a
nnmmnn femoral artery into the left and riaht uterine arteries by means of an
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intravascular catheter and embolic material, such as small metallic coils,
polyvinyl
alchohol particulate and the like, is delivered through the catheter to the
uterine
arteries which quickly become occluded.
[0005] The uterus has a dual (or redundant) blood supply, the primary blood
supply being from the bilateral uterine arteries, and the secondary blood
supply from
the bilateral ovarian arteries. Consequently, when both uterine arteries are
occluded, i.e. bilateral vessel occlusion, the uterus and the fibroids
contained within
the uterus are both deprived of their blood supply. However, as demonstrated
by
Ravina et al., the ischemic effects on the fibroid is greater than the effect
on the
uterus. In most instances, the fibroid withers and ceases to cause clinical
symptoms.
[0006] However, many physicians do not possess the training or equipment
necessary to perform catheter-based uterine artery embolization under
radiologic
direction. Accordingly, there are substantially fewer uterine artery
embolizations
performed, worldwide, each year than hysterectomies for symptomatic uterine
fibroids.
[0007] Recently, fibroid treatment procedures have been described wherein the
uterine arteries are temporarily occluded by an intravaginal device which is
non-
invasively pressed against the patient's vaginal fornix and clamped or
otherwise
pressed against tissue bundle with the patient's uterine artery being within
the
bundle. Pressure on the tissue occludes the underlying uterine artery. While
these
procedures have shown much promise, in many situations the devices described
to
date do not always allow for accurate placement of the clamping surfaces.
[0008] What is needed, therefore, are devices and methods to detect blood
vessels and blood flow in blood vessels, and devices and methods to occlude
blood
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flow in blood vessels such as the uterine arteries that can be used by
physicians with
limited training and equipment.
SUMMARY OF THE INVENTION
[0009] The invention is directed to a relatively non-invasive uterine artery
occlusion device and system and the procedure for using the device and system
for
occluding a female patient's uterine artery. The instruments and their use may
be
utilized in the treatment of uterine fibroids, dysfunctional uterine bleeding,
post
partum hemorrhage and other uterine disorders by reducing or terminating blood
flow through a patient's uterine artery.
[0010] A device embodying features of the invention includes an intrauterine
clamp which has a pressure applying or clamping member configured to apply
pressure against the exterior of the patient's uterine cervix or against the
patient's
vaginal fornix. The intravaginal clamp also has a stabilizing or positioning
member
which is configured to be inserted into the patient's uterine cervix so as to
stabilize at
least a portion of the interior of the uterine cervix and facilitate the more
effective
application of pressure by the pressure applying member to the exterior of the
cervix
or the vaginal fornix to ensure effective occlusion of the patient's uterine
artery. The
uterine artery occlusion is temporary, and may be partial or complete.
[0011] One method of occluding a blood vessel comprises clamping the blood
vessel effective to compress it so that blood flow through the vessel is
reduced, or is
abolished. Such clamping of a blood vessel may be direct or may be indirect.
Preferably, clamping of a blood vessel effective to compress it is
accomplished by
applying a non-invasive blood vessel occlusion device to tissue near to a
blood
vessel (e.g., onto tissue surrounding the vessel). A blood vessel occlusion
device
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may also be applied directly onto a blood vessel effective to compress the
blood
vessel.
[0012] In one embodiment of the invention, a non-invasive blood vessel
occluding
device (such as a clamp with a sensor) may be applied to a portion of a
vaginal wall
to detect and/or locate, and to occlude the uterine arteries. A vaginal clamp
embodying features of the invention may used to sense the location of a
uterine
artery adjacent a vaginal wall, and may be used to compress and occlude a
uterine
artery adjacent a vaginal wall. The vaginal wall may be distended by an
occlusion
device so as to more closely approach a uterine artery; such an approach may
aided
by applying pressure or force to the uterus (e.g., by pulling on the uterine
cervix). A
uterine cervix may be grasped or pulled by any suitable device or implement,
including forceps, suction devices, and other instruments, such as a
tenaculum.
[0013] A non-invasive blood vessel occluding device embodying features of the
invention may be a non-invasive intravaginal uterine artery occlusion device,
comprising a pair of pressure-applying members having opposed tissue-
contacting
surfaces on distal portions thereof; at least one supporting shaft extending
from a
proximal extremity of at least one of the pressure-applying members which is
configured to adjust the distance between the opposed tissue-contacting
surfaces of
the pressure-applying members; and at least one blood flow sensing sensor on
one
of the opposed tissue-contacting surfaces. An embodiment of a non-invasive
blood
vessel occlusion device embodying features of the invention may have, for
example,
a handle, a clamping member configured to apply pressure or force to body
tissue,
and a sensor for locating a blood vessel.
[0014] A pressure-applying member, such as a clamping member, may be, e.g., a
jaw or jaws configured to engage a blood vessel or to engage tissue adjacent a
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blood vessel. A supporting shaft, such as a handle, is preferably configured
for
manipulating the jaw or jaws. In some embodiments of devices having features
of
the invention, a pressure-applying member may be attached to a connecting
portion
that is configured so that a jaw may be placed within a vagina while a handle
remains outside a patient's body and available for use by an operator.
[0015] The clamping member is preferably provided with a blood flow sensor for
locating the blood vessel to be occluded. The sensor may sense sound,
pressure,
strain, stress, chemical entity, electromagnetic radiation and the like, and
may be a
combination of such sensors. A sensor is preferably a Doppler ultrasound
sensor.
The sensor is mounted to the face of a tissue-contacting surface of the
clamping
member, such as the face of a jaw of a clamp, and is preferably oriented
perpendicularly to the clamp face, although other orientations may be
employed.
Ultrasound energy useful for sensing a location of a blood vessel or of blood
flow in a
blood vessel has a frequency of less than about 20 MegaHertz (MHz), such as
between about 5 MHz and about 19 MHz, and preferably between about 6 MHz and
about 10 MHz. In commercially available Doppler sensors the frequency is
typically
about 8 MHz. For sensors based on electromagnetic energy useful for sensing a
location of a blood vessel or of blood flow in a blood vessel, the EM energy
should
have a wavelength of about 500 nanometers (nm) to about 2000 nm, preferably
about 700 nm to about 1000 nm.
[0016] A system embodying features of the invention includes an blood vessel
occluding device as described above with a blood flow sensor on the clamping
member for locating the target blood vessel, and a sensor controller which may
include an energy source for the sensor. The sensor controller may be
configured to
aid in detecting a location of a blood vessel, by, e.g., providing a signal
related to the
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output,of a sensor that may be readily used by an operator. A sensor
controller may
include an energy source configured to provide energy for operating a blood
flow
sensor.
[0017] A method for occluding a uterine artery which embodies features of the
invention include advancing the clamping device through the patient's vaginal
canal,
guiding the stabilizing member of the clamping device through the cervical os,
into
the cervical canal with the clamping member spaced from the stabilizing member
so
that the pressure applying surfaces of the clamping member is pressed into the
patient's vaginal fornix. Adjustment of the clamping member allows the sensor
on
the distal end thereof to locate the uterine artery a short distance from the
surface of
the vaginal fornix. With the clamping member adjacent to the target blood
vessel,
the clamping device can be closed to compress underlying tissue and thereby
occlude the uterine artery. The uterine artery is located with the blood flow
sensor
on the distal end of the clamping member. Tension may be applied to the
uterine
cervix with a grasping implement (e.g., by pulling on the uterine cervix)
while
applying force or pressure to a vaginal wall to occlude a uterine artery.
[0018] The invention allows for the non-surgical location and occlusion of
blood
vessels such as the uterine artery, providing effective therapeutic treatment.
Importantly, the present invention allows for the occlusion of a female
patient's
uterine artery without the need for radiographic equipment or for extensive
training in
the use of radiographic techniques. The devices and methods are simple and
readily used for treating uterine fibroids, dysfunctional uterine bleeding
(DUB),
adenomyosis, post-partum hemorrhage, and other uterine disorders. The devices,
systems and methods embodying features of the invention allow for the separate
occlusion of individual uterine arteries which provides effective therapy in
those
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situations in which the uterine anatomy will not allow for the use of a single
bilateral
artery occlusion device.
[0019] These and other advantages will become more apparent from the
following detailed description when taken in conjunction with the accompanying
exemlary drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] Figure 1 is an elevational view of a uterine artery clamping device
embodying features of the invention in an open configuration.
[0021] Figure 2 is a perspective view of the clamping device shown in Fig. 1.
[0022] Figure 3 is an enlarged perspective view of the distal portion of an
alternative clamping device having a serrated surface and a plurality of teeth
to
grasp tissue.
[0023] Figure 4 is an enlarged perspective view of an alternative clamping
device
in which the clamping element and the stabilizer element are provided with
teeth to
grasp tissue.
[0024] Figure 5 is a schematic illustration of the intra-uterine clamp in
position to
occlude a female patient's uterine artery.
[0025] Figure 6 is a perspective view of an alternative embodiment in which
the
clamping element and the stabilizing element are angled with respect to the
handles
of the clamp.
[0026] Figure 7 is a perspective view of an alternative embodiment in which
the
spacing between the stabilizing member and the clamping member is adjusted by
a
spring coil.
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[0027] Figure 8 is perspective view of an alternative embodiment in which the
spacing between the stabilizing member and the clamping member is adjusted by
a
rack and pinion arrangement.
DETAILED DESCRIPTION OF THE INVENTION
[0028] Figures 1 and 2 show a relatively non-invasive intra-uterine occluding
clamp 10 embodying features of the invention. The clamp 10 includes a clamping
member 11 having an elongated handle 12 with a finger grip 13, and pressure-
applying clamping element or jaw 14 on the distal end of the clamping element.
The
intra-uterine clamp also includes stabilizing member 15 which is configured to
readily
follow or track the patient's cervical os and cervical canal. The stabilizing
member
15 has an elongated handle 16 with a finger grip 17. The clamping member 11
and
stabilizing member 15 are pivotally connected to each other at pivot point 18
and
rotation of handles 12 and 16, preferably by fingers of an operator's hand
engaged
through grips 13 and 17 respectively, adjust the spacing between the jaw 14
and the
distal portion of stabilizing member 15. Each of the handles 12 and 16 are
provided
with a ratchet member 19 and 20 respectively which interact to lock the
relative
positions of the clamping member 11 and the stabilizing member 15.
[0029] A uterine artery clamp embodying features of the invention is
preferably
provided with a blood flow sensor 22, preferably a Doppler ultrasonic sensing
system, on the leading surface of the jaw 14. This sensor location allows the
operator to more easily guide the jaw 14 to the location of the patient's
target uterine
artery. Sensor 22 is provided with a signal transmission cable 23 which is
operatively
connected to sensor control device 24. Cable 23 may be an insulated wire,
plurality
of wires, optical fiber, waveguide, or other connection effective to carry
signals
and/or energy or power between a sensor 22 and sensor controller 24.
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[0030] Sensor 22 may be a blood flow sensor for locating a blood vessel, and
may be a passive sensor, configured to detect intrinsic signals indicating the
presence of a blood vessel (i.e., a sound sensor, a motion sensor, a pH
sensor, or
other sensor configured to detect a physical, chemical, electrical, or
physiological
indication of the location of a blood vessel). In other embodiments, a blood
flow
sensor for locating a blood vessel may be an active sensor, configured to emit
energy or a signal, and configured to detect signals in response to, or
derived from,
the emitted energy or signal indicating the presence of a blood vessel (i.e.,
a source
of ultrasound having an ultrasound sensor configured to detect ultrasound
reflections
from a blood vessel, a source of infrared radiation configured to detect
reflections
from a blood vessel, or other source of energy and a sensor configured to
detect a
response indicating the location of a blood vessel). The operation of a sensor
may
be aided by an energy source such as the sensor controller 24. For example, an
energy source may provide electrical energy which aids an ultrasound sensor to
produce and to detect ultrasound energy (as, e.g., in the MedaSonics
CardioBeat
Blood Flow Doppler with Integrated Speaker (Cooper Surgical, Inc., Trumbull CT
06611)). Other commercially available Doppler ultrasound sensors suitable for
use
in the present invention include the Koven model ES 10OX MiniDop VRP-8 probe
(St. Louis, MO) and the DWUNeuro Scan Medical Systems' Multi-Dop B+ system
(Sterling, VA).
[0031] As shown in Fig. 3 jaw 14 may be provided with a serrated, tissue-
grasping surface 25 configured to engage and hold onto tissue when jaw 14 is
pressed into tissue of the patient's vaginal fornix. As shown in Fig. 4, one
or both of
the jaw 14 and/or stabilizer 15 may have retractable fingers or teeth 26 to
better
secure the contacting members to the target tissue.
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[0032] Figure 5 illustrates an alternative embodiment wherein the clamping
member 11 and the stabilizing member 15 are oriented at an angle 0 with
respect to
the handles 12 and 16. The angulation provides a more direct attack angle to
facilitate insertion of the stabilizing member 15 into the patient's cervix
and direction
of the jaw 14 toward a desired location at the patient's vaginal fornix to
facilitate
location and occlusion of the patient's uterine artery. Suitable angulation 0
of the jaw
14 and stabilizer 15 is about 1000 to about 175 , preferably about 130 to
about
160 .
[0033] Closure of a blood vessel, which may be partial or total, is effected
by
pressure applied through the wall of the patient's vaginal fornix. Sufficient
pressure
or force applied to the tissue of the vaginal wall to compress and to at least
partially
occlude the underlying uterine artery. The blood flow sensor for detecting or
locating
the uterine artery should be disposed on the leading face off the clamping
element
and generally perpendicular to the tissue-contacting surface of a jaw 14 to be
effective.
[0034] A non-invasive blood vessel occluding device embodying features of the
invention may be configured to lock into a clamping position. Such a locked
configuration may be temporary and releasable, or may be permanent. Non-
invasive
blood vessel occluding devices embodying features of the invention may have a
locking mechanism, such as a ratchet, configured to hold at least one pressure-
applying member in a pressure-applying position. Such locking mechanisms may
include a release mechanism effective to allow the cessation of pressure or
force
application when desired. Thus, a non-invasive blood vessel occlusion device
embodying features of the invention may be configured to release a locking
mechanism effective to relieve the occlusion of a blood vessel by ending the
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application of pressure or force that had been previously applied to occlude a
blood
vessel.
[0035] The uterine arteries in human females are located adjacent the vaginal
mucosa at a location within a few centimeters (cm) of the vaginal fornix. As a
result,
for accessing and occluding a uterine artery from within the patient's vaginal
canala,
the dimensions of a vagina determine what size clamping device is suitable,
taking
into consideration that the clamping device should readily reach the vaginal
fornix
and be operated from outside of a patient's body. For example, a clamping
device
may be between about 5 to about 16 inches in length, preferably between about
6
inch to about 12 inches in length for most applications.
[0036] Figure 6 schematically illustrates in part a human female reproductive
system, including a uterus 30, uterine cervix 31, uterine artery 32, vaginal
canal 33
and vaginal fornix 34. A method of using the uterine artery clamp embodying
features of the invention includes introducing the clamp 10 into the patient's
vaginal
canal 33 and advancing the clamp therein until the distal portions of the
clamp are
adjacent to the patient's uterine cervix 31. The position of the handles 12
and 16 are
adjusted to increase the spacing between the jaw 14 and the distal portion of
the
stabilizer 16. The distal end of the stabilizer is guided through the cervical
os 35 into
the uterine cervix. The distal end of jaw 14 is urged against the vaginal
fornix 34 and
14. With the guidance of the Doppler sensor 22, the pressure applying surface
of
the jaw is positioned as close as possible to the patient's uterine artery 32.
Sufficient
pressure is applied to the uterine artery 32 or the tissue surrounding the
uterine
artery by jaw 14 to facilitate occlusion of the uterine artery. The handles 12
and 16
are locked by ratchet members 19 and 20 to press the jaw 14 against the tissue
between the jaw 14 and the stabilizer 15. The clamped position is maintained
for
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about 0.5 to about 48 hours, preferably about 1 to about 24 hours for
effective
therapeutic treatment of a uterine disorder, e.g. for fibroids, PPH, DUB and
the like.
Blood flow sensor 22 is effective to locate uterine artery 48 by detecting
blood flow
and monitoring the treatment by detecting the lack of blood flow in the
artery. Blood
flow in the left uterine artery 50 may be similarly occluded, by a separate
uterine
artery clamp of the same design or the same clamp can be used on the other
side
after release of the occlusion of the right uterine artery 34.
[0037] The ratchet members 19 and 20 are preferably releasable so that
clamping member 11 of clamping device 10 can be released after the limited
treatment time to re-establish blood flow to the uterine tissue.
[0038] Figures 7 and 8 illustrate alternate clamp design wherein the spacing
between the jaw 14 and stabilizer 15 is controlled by a spring 40 as shown in
Fig. 7
and a rack and pinion mechanism 50 as shown in Fig. 8. A variety of other
means
may be employed to open and close the jaw 14 and stabilizer 15.
[0039] Uterine artery clamp 10 embodying features of the invention may be made
from any suitable material or combination of materials, including metals such
as
stainless steel and superelastic shape memory alloys such as nickel titanium
alloys
having a stable austenite phase at body temperature, high strength plastics,
ceramics, and other materials known in the art. Biocompatible polymers such as
polycarbonate, polysulfone, polyester, polyacetal and a variety of
fluoropolymers can
be suitable for a variety of embodiments of the invention. The device or
system may
be designed for single use (disposable) or may be sterilizable and capable of
multiple use.
[0040] While particular forms of the invention have been illustrated and
described,
it will be apparent that various modifications can be made to the invention
and that
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individual features shown in one embodiment can be combined with any or all
the
features of another embodiment described herein. Accordingly, it is not
intended
that the invention be limited to the specific embodiments illustrated. It is
therefore
intended that this invention be defined by the scope of the appended claims as
broadly as the prior art will permit. Terms such as "element", "member",
"device",
"sections", "portion", "section", "steps" and words of similar import when
used herein
shall not be construed as invoking the provisions of 35 U.S.C. 112(6) unless
the
following claims expressly use the terms "means" or "step" followed by a
particular
function without specific structure or action.
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