U.S. patent application number 13/830202 was filed with the patent office on 2014-05-08 for biopsy and sonography method and apparatus for assessing bodily cavities.
The applicant listed for this patent is Cross Bay Medical, Inc.. Invention is credited to Steven R. BACICH, Cristiano Danilo Maria FONTANA, Donnell W. GURSKIS, Kelly H. ROY, Piush VIDYARTHI.
Application Number | 20140128732 13/830202 |
Document ID | / |
Family ID | 50622984 |
Filed Date | 2014-05-08 |
United States Patent
Application |
20140128732 |
Kind Code |
A1 |
ROY; Kelly H. ; et
al. |
May 8, 2014 |
BIOPSY AND SONOGRAPHY METHOD AND APPARATUS FOR ASSESSING BODILY
CAVITIES
Abstract
Apparatuses and methods for performing a procedure on a uterine
cavity of a patient are disclosed. The methods can include
visualizing the uterine cavity, biopsying a tissue with a biopsy
device, and ejecting fluid from the biopsying device into the
uterine cavity. The apparatuses can have a sealable acorn tip, a
handle, a repositioning clip, a distal indicia, proximal indicia,
and a fluid reservoir. The biopsying device can be configured to
biopsy and eject fluid under the control of a single hand of a user
of the device.
Inventors: |
ROY; Kelly H.; (Phoenix,
AZ) ; BACICH; Steven R.; (Half Moon Bay, CA) ;
VIDYARTHI; Piush; (San Rafael, CA) ; GURSKIS; Donnell
W.; (Belmont, CA) ; FONTANA; Cristiano Danilo
Maria; (Milan, IT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Cross Bay Medical, Inc. |
Irvine |
CA |
US |
|
|
Family ID: |
50622984 |
Appl. No.: |
13/830202 |
Filed: |
March 14, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61723114 |
Nov 6, 2012 |
|
|
|
Current U.S.
Class: |
600/431 ;
600/407; 600/462; 600/562 |
Current CPC
Class: |
A61B 8/12 20130101; A61B
8/42 20130101; A61B 8/4416 20130101; A61B 10/0283 20130101; A61B
10/0291 20130101 |
Class at
Publication: |
600/431 ;
600/562; 600/462; 600/407 |
International
Class: |
A61B 10/02 20060101
A61B010/02; A61B 8/12 20060101 A61B008/12; A61M 25/00 20060101
A61M025/00; A61B 8/00 20060101 A61B008/00 |
Claims
1. A method of performing a procedure on a uterine cavity of a
patient, comprising: visualizing the uterine cavity; biopsying a
tissue comprising at least one of advancing, rotating, and
withdrawing a biopsy device into the uterine cavity, wherein the
biopsy device comprises a sealable tip on a repositionable
component, proximal indicia and distal indicia; and ejecting fluid
from the biopsying, device into the uterine cavity, wherein the
biopsying device is configured to biopsy and eject fluid under the
control of a single hand of a user of the device.
2. The method of claim 1, wherein the visualizing is concurrent
with the biopsying.
3. The method of claim 1, wherein the visualizing is concurrent
with the ejecting of the fluid.
4. The method of claim 1, wherein the visualizing comprises
diagnostically visualizing.
5. The method of claim 1, further comprising removing the biopsy
device from the uterine cavity and then inserting a medical device
into the uterine cavity.
6. The method of claim 1, wherein ejecting the fluid comprises
ejecting a gel into the uterine cavity.
7. The method of claim 1, wherein ejecting the fluid comprises
ejecting a foam into the uterine cavity.
8. The method of claim 1, wherein ejecting the fluid comprises
ejecting a contrast agent into the uterine cavity.
9. The method of claim 1, wherein ejecting the fluid comprises
ejecting a or therapeutic agent into the uterine cavity.
10. The method of claim 1, wherein the tip comprises a rigid
plate.
11. The method of claim 10, wherein the rigid plate is embedded in
the tip.
12. The method of claim 1, wherein the tip is acorn-shaped.
13. An apparatus for performing a procedure on a uterine cavity of
a patient comprising: a sealable acorn tip; a handle comprising a
pumping lever and a biopsy instrument, wherein the biopsy
instrument is configured to translate and rotate with respect to
the handle; a repositioning clip; a distal indicia; a proximal
indicia; and a fluid reservoir.
14. The apparatus of claim 13, wherein the tip is acorn-shaped.
15. The apparatus of claim 13, wherein the tip comprises a rigid
plate.
16. The apparatus of claim 13, wherein the rigid plate is embedded
in the tip.
17. The apparatus of claim 13, wherein the fluid reservoir
comprises a refillable fluid bag.
18. The apparatus of claim 13, wherein the biopsy instrument is
configured to advance
19. The apparatus of claim 13, wherein the biopsy instrument is
configured to withdraw
20. An apparatus for performing a procedure on a uterine cavity of
a patient comprising: an elongated member; a sealable tip; a
handle; a repositioning clip; a distal judicial; a proximal
indicia; a fluid reservoir; and a vaginal ultrasound probe
comprising a rotatable clip attached to at least one of the
elongated member and the handle.
21. The apparatus of claim 20, wherein the tip is acorn-shaped.
22. The apparatus of claim 20, wherein the tip comprises a rigid
plate.
23. The apparatus of claim 20, wherein the rigid plate is embedded
in the tip.
24. The apparatus of claim 20, wherein the fluid reservoir
comprises a refillable fluid bag.
25. The apparatus of claim 20, wherein the rotatable clip is
configured to be translatable along at least one of the elongated
member and the handle.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims the benefit of U.S. Provisional
Application No. 61/723,114, filed 6 Nov. 2012, which is
incorporated by reference herein in its entirety.
FIELD OF THE DISCLOSURE
[0002] The present disclosure generally relates to procedures for
assessing bodily cavities such as the uterine cavity. Such
procedures utilize ultrasonography and the removal of bodily tissue
for further pathological analysis. Methods for the assessment of
the uterine cavity and endometrial lining of the uterus can be
performed by the devices disclosed herein. Methods of the delivery
of drugs, agents, and therapeutic devices in targeted locations of
the uterus are disclosed herein. Methods for performing an
endometrial biopsy and saline infusion sonography (SIS) in a
simplified fashion that can enable the physician to perform these
procedures while simultaneously operating ultrasonographic probes
are disclosed.
BACKGROUND
[0003] In gynecological practice, it is standard for women to
undergo procedures to assess their uterine cavities and the
endometrial tissue, in particular for woman suffering from abnormal
bleeding, infertility, suspected cancer, sexually transmitted
diseases, pelvic pain, and other maladies of the reproductive
tract. These procedures include making an assessment of the uterine
cavity with or without saline infusion, assessing the patency of
the fallopian tubes, determining the thickness of endometrial
lining as per the time of the woman's cycle, examining for uterine
abnormalities such as polyps, adhesions, and fibroids within the
cavity or wall of the uterus, and performing an biopsy of the
uterine lining. As part of the work up, these standard procedures
typically are performed in an office setting or small suite without
the use of anesthesia for the patient. Since these procedures are
typical in the gynecological work up of a patient, a gynecologist
could be expected to perform many assessments of the uterine cavity
during the course of patient consultations and visits.
[0004] Specifically during a uterine cavity assessment, the
gynecologist will access the cervix through the vagina by utilizing
a speculum. The gynecologist may or may not use a tenaculum to
stabilize or straighten the cervical canal depending upon the
anatomy and physician preference. For greater patient comfort, the
gynecologist seeks to reduce the amount of materials that enter the
patient's vagina as well as minimize the number of times different
devices need to be inserted within the patient. Patient comfort is
further enhanced by a reduced procedural time and due to capitated
fee structures and scheduling constraints, the gynecologist also is
incentivized to reduce procedural time yet obtaining a proper and
efficient diagnosis is paramount.
[0005] Using either a vaginal or abdominal ultrasonographic probe,
a general assessment of the uterus and surrounding organs can be
performed. In an effort to simplify the assessment of the uterine
cavity, gynecologists have incorporated the use of saline infusion
to distend the cavity and provide further contrast for the
detection of uterine cavity abnormalities. The continued injection
of saline with or without the use of Doppler ultrasound can provide
further information on fallopian tube patency if a spill or free
flow of saline in the peritoneal space can be visualized by
ultrasound. In some cases the saline can be enhanced for
ultrasonography if bubbles or foams are incorporated into the
saline fluid. In an effort for further echogenicity, the saline can
be replaced by gels that are known to have higher contrast for
ultrasonographic detection.
[0006] To perform these infusions, gynecologists have employed a
variety of catheter tools and many of these devices are indicated
for other procedures. For instance, it is standard practice for
physicians to use insemination catheters for the infusion of saline
into the uterine cavity since these devices are small in diameter
or profile, do not require cervical dilation, and they are readily
available in the gynecologist's practice. These insemination
catheters are typically characterized as single lumen catheters
with a smooth distal end opening, flexible shaft, indicia for
uterine depth markings in centimeter increments, and a proximal
luer connector or coupling for connecting a syringe or fluid
source. These simple catheters have no ability to improve the
distension of the uterine cavity during infusion and in a majority
of cases, especially in multi-parous women, a significant amount of
the fluid will escape through the cervical canal.
[0007] Other catheters have been developed that improve the
infusion of saline through the incorporation of means for blocking
or sealing the cervical canal. These catheters also have
applications for the fluoroscopic or x-ray assessment of the
uterine cavity in a procedure known as hysterosalpingography
whereby contrast agents and fluids are injected into the uterine
cavity and fallopian tubes for assessment for radiographic
techniques. In one form, these catheters have balloons on their
distal ends which seal the cervical canal within the lower uterine
segment. Following insertion in to the uterine cavity, these distal
balloons are inflated and pulled back proximally to allow for the
balloon to engage and seal within the lower uterus at the upper
endocervical canal. Once pulled into and pressed into the
endocervix, the balloon provides a seal for the distension of the
uterine cavity. These distal balloons can obscure the lower uterine
cavity region from ultrasonographic analysis.
[0008] Other catheters have acorn or bulbous tips near their distal
end. The purpose of these acorn tips is to occlude the exocervix
and thereby maintain pressure or distension in the uterine cavity.
In practice the gynecologist presses the acorn tip into and against
the exocervix to occlude the cervical opening to improve uterine
distension. These acorn tips have come in a variety of shapes and
sizes. Typically they are not efficient in providing an adequate
seal in most women since the exocervix in women can be highly
irregular. Some systems have utilized a tenaculum to provide a
compressive force to help stabilize and enforce the pressure of the
acorn tip against the exocervix. In practice this combination can
be uncomfortable for the patient, especially during the manual
injection of fluids or saline into the uterine cavity.
[0009] During the gynecological assessment of the uterine cavity,
it is desirable to obtain a portion of tissue for pathological
analysis. Some devices incorporate the use of vacuum at the distal
tip (e.g., PIPELLE.RTM. manufactured by Cooper Surgical, Inc. of
Trumbull, Conn.). These devices may utilize an inner mandrel that
is withdrawn proximally by the physician to create a vacuum force.
The vacuum force draws fluid and tissue into the distal opening of
the catheter within the uterus. Once removed from the uterine
cavity, the distal catheter is placed into a specimen container and
the inner mandrel is advanced to expel the contents collected in
the distal end into the specimen container.
[0010] Another biopsy device utilizes a brush within the inner
catheter that is advanced from the distal end of the catheter which
is placed within the uterine cavity. The brush (e.g., TAO BRUSH.TM.
manufactured by Cook Medical, Inc of Bloomington, Ind.) is advanced
from the distal end of the catheter. The brush is typically rotated
in situ to increase the amount of contact with the tissue in the
uterine cavity. After several rotations the brush is withdrawn back
into the distal end of the catheter and the entire device is
removed from the uterus and body of the patient. Once removed, the
inner brush is advanced beyond the distal end of the catheter
within a specimen container partially filled with fluid or saline.
The brush is agitated within the fluid so that tissue on the brush
can be released into the fluid so that the specimen container can
be processed by the pathologist.
[0011] Both of these biopsy devices typically collect tissue
without visualization and the devices provide no means for
determining their location with the use or ultrasound of
radiographic techniques. Thereby the location of the biopsy sample
is not known.
[0012] Several researchers have sought to simplify the combination
of ultrasonography and pathological analysis in the uterine cavity
by reducing the number of devices required for insertion in the
practice setting. The device (e.g., GOLDSTEIN CATHETER.TM.
manufactured by Cook Medical, Inc of Bloomington, Ind.) can employ
a single catheter lumen, a distal opening, a distal shaft with
indicia for depth markings, a slideable acorn tip, a proximal
coupling used for both the injection of fluid such as saline from
the distal end opening, and a vacuum source such as a syringe that
will cause fluid and tissue to be withdrawn into the distal
opening. In practice, the physician has to simultaneously maintain
uterine cavity position and distension with the acorn tip, while
manipulating a syringe at the proximal end. In this situation, the
physician cannot also operate the ultrasound probe and equipment
and would need the assistance of a nurse and technician. In
addition, to operate the biopsy mechanism, vacuum needs to be
employed within the inner catheter thereby removing all distension
and visibility in the uterine cavity. Also, with a vacuum force at
the distal end of the catheter, the ability to re-position or
re-direct the location of the distal end of the catheter, and what
tissue is being collected, is significantly minimized.
[0013] In U.S. Pat. No. 8,157,745 to Schoot, which is incorporated
by reference herein in its entirety, a method and apparatus is
described that combines features of a saline infusion system and a
biopsy device that withdraws tissue and fluid within its distal end
opening by the withdrawal of an inner mandrel. In Schoot, an acorn
tip is fixed to an outer catheter with an inner, slideable,
concentric catheter. Within the inner catheter is housed an inner
mandrel configured to provide a vacuum force once withdrawn by the
physician from at the proximal end. The Shoot system provides a
saline source. Using the Schoot device, the physician has to
simultaneously maintain uterine cavity position and distension with
the acorn tip, while manipulating the withdrawal of the inner
mandrel within the inner catheter at the proximal end. In this
situation, the physician cannot also operate the ultrasound probe
and equipment and would need the assistance of a nurse and
technician. In addition, to operate the biopsy mechanism, vacuum is
created by withdrawing the inner mandrel and this action removes
all distension and visibility in the uterine cavity. Also, with a
vacuum force at the distal end of the catheter, the ability to
re-position or re-direct the location of the distal end of the
catheter, and what tissue is being collected, is significantly
minimized.
[0014] In practice, it would be beneficial to the physician to have
a simplified system that could perform uterine cavity assessments
without the need for further technicians, assistants, nurses or
manpower, yet maintain a high quality diagnosis. For uterine cavity
distension, it would be beneficial if the sealing mechanism of the
exocervix was improved. In addition, it would be beneficial if the
biopsy system could be easily directed and visualized to allow for
a targeted collection of tissue.
SUMMARY OF THE INVENTION
[0015] A method of performing a procedure on a uterine cavity of a
patient is disclosed. The method can include visualizing the
uterine cavity, biopsying a tissue with a biopsy device, and
ejecting fluid from the biopsying device into the uterine
cavity.
[0016] The biopsying can include at least one of advancing,
rotating, and withdrawing the biopsy device into the uterine
cavity. The biopsy device can have a sealable tip on a
repositionable component, proximal indicia and distal indicia. The
biopsying device can be configured to biopsy and eject fluid under
the control of a single hand of a user of the device.
[0017] An apparatus for performing a procedure on a uterine cavity
of a patient is also disclosed. The apparatus can have a sealable
acorn tip, a handle, a repositioning clip, a distal indicia, a
proximal indicia, and fluid reservoir. The handle can have a
pumping lever and a biopsy instrument. The biopsy instrument can be
configured to translate and rotate with respect to the handle.
[0018] A further apparatus for performing a procedure on a uterine
cavity of a patient is disclosed. The apparatus can have an
elongated member, a sealable tip, a handle, a repositioning clip, a
distal judicial, a proximal indicia, a fluid reservoir; and a
vaginal ultrasound probe. The probe can have a rotatable clip
attached to at least one of the elongated member and the
handle.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] FIG. 1 illustrates one example of a device, not the
invention, within the cross-section of a uterine cavity.
[0020] FIGS. 2a, 2b, 2c, and 2d illustrate examples of acorn tips,
not the invention, engaging a cross-section view of an exocervix of
a patient.
[0021] FIGS. 3a and 3b illustrate one configuration of a new
sealable acorn tip in a cross-sectional view of a uterine cavity of
a patient.
[0022] FIGS. 4a and 4b illustrate one configuration of a device for
performing simultaneous sonography and biopsy with partial cross
sectional views.
[0023] FIGS. 5a and 5b illustrate one configuration of an apparatus
for performing simultaneous sonography and biopsy that engages a
vaginal ultrasound probe during a uterine cavity assessment.
DETAILED DESCRIPTION
[0024] In FIG. 1 illustrates a device 1 within a cross-sectional
view of the uterine cavity 20. The distal end of the device 3 is
shown with a distal end opening 4, inner lumen 6, and indicia 5 for
determining the depth of insertion within the uterine cavity using
the exocervix 30 of the cervix or endocervical canal 31 as a frame
of reference. Located at the exocervical opening 30, an acorn tip
50 is placed and pressed into the exocervical opening 30 to provide
a seal for media within the uterine cavity 20. A connector or
coupling 60 can be located on the proximal end of the device 1.
This coupling 60 can be configured as a stopcock, T-connector or
Y-connector to allow for the injection of fluids or media into
connector opening 61. This connector opening 61 can be configured
as a luer connector to allow for the connection of a syringe 63 or
other fluid supplying source. In operation the syringe 63 or other
fluid supplying source 64 can be used to distend the uterine cavity
20 when performing an ultrasonographic or radiographic examination
of the uterine cavity. Ultrasonography and radiographic equipment
are not shown. From connector opening 61, a syringe 63 or other
vacuum supplying source can be can be connected to supply negative
pressure within the inner lumen 6 of device 1 to withdraw fluid and
tissue from the uterine cavity within the distal end opening 4.
[0025] The acorn tip 50 can be positioned at the exocervical
opening 30. The acorn tip 50 can be configured in a conical shape
with smaller diameter distal end 51 and larger diameter proximal
end 52. The acorn tip 50 can be slid or re-positioned on distal end
of the device 3 to correspond to the desired depth of insertion as
indicated by the indicia 5. In practice, a physician may perform a
scout film of the uterine cavity 20 by use of the ultrasonographic
or radiographic equipment, both not shown in FIG. 1.
[0026] The inner lining 21 of the uterine cavity 20 is a potential
space. To visualize features, contours and structures within the
uterine cavity 20, distension media 70 can be supplied from syringe
63 or other fluid supplying source. The inner most part of the
inner lining 21 is the endometrial lining 22 in which this tissue
and cells are desired for pathological analysis. Other structures
such as polyps, myomas, adhesions, fibroids, septated tissue, and
other implantable devices may be located within of protruding into
the uterine cavity 20 at the time of examination and their
visualization is facilitated by the distension media 70 which
separates the potential space (not shown as a potential in these
sketches) within the uterine cavity 20.
[0027] FIGS. 2a, 2b, 2c, and 2d illustrate examples acorn tips 50
or similar devices that can engage the exocervical opening 30 of a
patient, shown in cross-section. In FIG. 2a, another acorn tip is
depicted as a cylindrical block 52 with outer diameter 53. In
practice, the cylindrical block 52 is made of rigid materials such
as stainless steel, plastic, or combination of both and is designed
to be pressed against the exocervical opening 30. The cylindrical
block 52 can have a distal end surface 54 that can be flat, convex,
or concave. In FIG. 2a, the cylindrical block is shown with distal
end surface 54 drawn as a convex surface.
[0028] FIG. 2b illustrates a cervical cup 55 which is similar in
function to the acorn tip. The cervical cup is designed to engage
the exocervical opening with leading edge 57. The area surrounding
the exocervical opening 30 is engaged by outer rim 56 of the
cervical cup 55. Within the cervical cup 55, a lumen 58 is
connected to a syringe 63 or other vacuum supplying source, not
shown. By applying vacuum pressure within the cervical clip 55, the
outer rim 56 is compressed against the area surrounding the
exocervical opening 30 to create a seal.
[0029] FIG. 2C illustrates a balloon 90 that is placed on the
distal end portion 3 of a device 1. The balloon can be inflated by
air, gas, fluid, saline, or contrast agent through connection 91 by
a syringe 63 or other fluid or air supplying source, not shown. In
theory the balloon can be placed on a separate, concentric catheter
body 11 so that the insertion depth of the device 1 can be
configured appropriately as per the patient's anatomy. In practice,
due to the pressure from the air or fluid within the balloon 90,
the balloon 90 can back away proximally from the exocervical
opening 30 unless stabilizers are employed by a tenaculum, not
shown, on the cervix 31.
[0030] FIG. 2d illustrates another variation of balloon 90 which is
inflated within the endocervical canal 31 to create a seal. In this
configuration, the air or fluid pressure from the balloon 90 on the
endocervical canal can create additional pain and discomfort for
the patient. In practice, since the endocervical canal can be
irregular in shape, inner diameter, or tortuosity, a balloon 90 can
be difficult to stabilize within the cervix 31 without
modifications to the balloon surface for greater adhesion to the
inner lining of the endocervical canal, or the use of tenaculum
stabilizer as described above. Finally, placing the balloon 90
within the uterine cavity 20 at the distal end of the endocervical
canal 31 is less desirous since the presence of balloon 90 can
obscure anatomical features within uterine cavity 20 during the
examination.
[0031] FIG. 3a illustrates one configuration of a new sealable
acorn tip 101 about to engage a cross-sectional view of an
exocervical opening 30, of a patient. The sealable acorn tip 101
has a smaller distal end 102, in profile, than the proximal end 103
and a length 104. The sealable acorn tip 101 is made from a
deformable, resilient material such as silicone. The silicone
material can be made from durometers as low as 5 and as high as 60
with 10 to 20 durometer being optimal. Within the sealable acorn
tip 101 a separate back plate 105 is placed. Back plate 105 is made
from a rigid plastic or metal, and has a diameter or profile less
than proximal end 103. The sealable acorn tip 101 can be placed on
a translatable or slidable outer catheter 110 that is configured to
slide on the distal end portion 3 of device 1. Back plate 105 can
be attached to the distal end of outer catheter 110. Back plate 105
can be embedded within sealable acorn tip 101 with pad area 108.
Sealable acorn tip 101 can be free floating on outer catheter 110
and can stay attached to back plate 105 through a process of insert
molding or other mechanical attachment. Back plate 105 can be
affixed to outer catheter 110 or its shaft 111. Thus, areas 113 in
FIG. 3a indicate areas without direct adhesion of the sealable
acorn tip 101 and outer catheter 110 and shaft 111. Holes and other
mechanical features within the back plate 105 create mechanical
fixation for the sealable acorn tip 101. The sealable acorn tip 101
can be directly adhered to the back plate 105. In addition, outer
catheter 110 and shaft 111 can have a re-positionable clip 112 on
the proximal end of area 113.
[0032] FIG. 3a also shows sealable acorn tip 101 with leading
distal end 102 that is flexible, resilient, and adapted to have a
minimal profile for entry into the exocervical opening 30. Just
proximal to the distal end 102, a curved, funnel-shaped neck 106
transforms from a concave curve 107 into a larger diameter, convex
curve 108 just before the back plate 105 located at the proximal
portion of the sealable acorn tip 101. The inflection point 109 can
be located at a distance equal to 50%, plus or minus 20%, of the
length 104 of the sealable acorn tip 105. By this terminology, an
inflection point 109 at 70% would be closer to the proximal end 103
of the sealable acorn tip 101 and would in turn have a longer neck
portion 106 and shorter pad area 108. The diameter of the proximal
end 103 can be a equal to or larger than 100% larger than the
diameter of the distal end 102, or equal to or larger than 200% the
diameter of the distal end 102.
[0033] FIG. 3b illustrates the sealable acorn tip 101 in use while
forward pressure is being applied by the physician (not shown). The
sealable acorn tip 101 provides a sealing element to the
endocervical canal 31 to provide distension in the uterine cavity
20 as a result of the free floating aspect and re-formable shape of
the sealable acorn tip 101. As the physician provides forward
pressure on the device, the back plate 105 and re-forms the
sealable acorn tip 101 by providing a re-forming surface from
within the sealable acorn tip 101. The distal end 102 intubates the
exocervical canal and the bulging proximal end 103, which expands
in outer diameter in response to the forward pressure, serves to
occlude the endocervical canal 31. Also in response to forward
pressure, neck portion 106 expands in outer diameter and depending
upon the patient anatomy and the forward pressure applied by the
physician, the entire length of the sealable acorn tip can compress
up to 50%. In FIG. 3b, distal surface of back plate 105 is
illustrated as a flat surface but the distal surface may be convex,
conical, or contain multiple projections to provide further
re-forming force to the sealable acorn tip 101.
[0034] The sealable acorn tip 101 can be resilient and translucent,
for example, so the physician has visibility of the approaching
cervix as the device is being inserted. The sealable acorn tip can
have an illumination element or LED (not shown) that can provide
additional light within the vagina. Illumination can be provided in
a co-axial fashion as an added component to the outer catheter
shaft 110, illumination not shown.
[0035] The sealable acorn tip 101 can be applied to a number of
devices and sheaths that are used in uterine cavity assessment
without biopsy including diagnostic and operative hysteroscopy,
hysterosalpingography, SIS, and intrauterine insemination.
[0036] FIG. 3a illustrates that re-positionable clip 112 can be
located the proximal end 113 of outer catheter 110, for example, to
provide a pre-determined insertion depth for the device within the
uterine cavity 20. Re-positionable clip 112 can have two
configurations. In the normal or resting state, the re-positionable
clip 112 can provide a fixation force with holding grips 117 for
outer catheter 110 on distal end portion 113 of a device. When
outer tabs 116 of the re-positionable clip 112 are compressed,
holding grips 117 can be released or open to remove the fixation
force. Thus the re-positionable clip 112 can have a resilient force
in the closed position to hold the repositionable clip 112 on the
device. The re-positionable clip can be configured to close upon
the compression force supplied by the physician and open upon a
releasing force by the physician.
[0037] FIG. 4 illustrates one configuration of an apparatus for
performing simultaneous, concurrent, or concomitant sonography and
biopsy. At the proximal end of device 200, there is a handle 210,
which is shown in partial cross section. The handle 210 can be
grasped by the physician with one hand. Within handle 210, there
can be a lever 220 shown in two positions. In Position A, the lever
can have a fluid bag 230 that can contain saline, contrast agent,
therapeutic agent such as lidocaine, or other solution that enables
visualization by ultrasonography or radiography, or combinations
thereof. In Position B indicated in the drawing, the lever 220 can
be depressed closer to handle 210 which forces the fluid in bag 230
to be ejected from the device 200 at its distal end 205. Lever 220
facilitates the delivery of fluid from bag 230 since the physician
does not need to move or withdraw his or her hand to force the
action to occur. Prior to ejecting the fluid, and near the index
finger of the physician, there can be a lever or trigger 240 that
can be actuated by the physician prior to ejecting the fluid.
Trigger 240 can be a gate valve, stop cock, or pinch valve but can
be positioned and actuated without requiring the physician to use
another hand, or change hand position, on handle 210. Actuating the
trigger 240 opens the conduit 250 pass the valve 241 and through
conduit 251. From there fluid flows through T-connector 260 with
o-ring seal at its proximal end 261. The o-ring seal (not shown)
allows for a biopsy instrument 300 to translate and rotate through
T-connector 260 without a loss of fluid or leak at the proximal end
261.
[0038] Alternatively, trigger 240 mechanism can be a check valve
(not shown) that can remain in the closed condition or state until
the physician squeezes the fluid bag 230 with enough force to open
the cracking pressure of the check valve. Such cracking pressure
can be 1 to 2 psi or greater.
[0039] Handle 210 can contain a mechanism for advancing, rotating,
and retracting a biopsy installment 300 contained within the
central lumen of device 200. Advancement and retraction of the
biopsy instrument 300 can be done by pushing button 310 forward or
backward on track 311. The position of button 300 can be placed to
allow a one-handed approach to actuating the biopsy instrument 300
without requiring the physician to move or alter his or her hand
position throughout the entire procedure. In practice, the biopsy
instrument 300 can be advanced forward along track 311 in the
translational direction indicated by motion 315. Once advanced, the
biopsy component 301, shown as biopsy bristles or brushes, can be
positioned inside the uterine cavity (not shown) and beyond the
distal end 205 of device 200. Other biopsy components are feasible
including ridges, mechanical shavers, or graspers (not shown).
Moreover once advanced from the distal end 205 of device 200, turn
knob 312 is provided on handle 210 that can be easily rotated, as
indicated by motion 313. The motion 313 serves to rotate the
central core 314 of the biopsy instrument 300 and thereby rotates
the biopsy components 301 in the motion 317 indicated. Once rotated
inside the uterine cavity (not shown), the biopsy instrument 300 is
withdrawn back into the distal end 205 of device 200 by retracting
the button 310 back along track 311.
[0040] Outer catheter 240 can be at the mid-section of device 200.
Outer catheter 240 can contain a reposition clip 248 at its
proximal end and a sealable acorn tip 245 at its distal end. FIG.
4a depicts the sealable acorn tip 245 in a state prior to
intubation within the exocervix of a patient (not shown). FIG. 4b
depicts the sealable acorn tip 245 in a state in which the
physician has placed the device 200 under a compressive force
against the exocervix (not shown) in which the sealable acorn tip
is depicted with bulging proximal end as a result of the back plate
pushing the proximal pad and neck as a result of the flee floating
attachment of the sealable acorn tip 245 that was described
earlier.
[0041] As described earlier, re-positionable clip 248 can be placed
in a state that locks outer catheter 240 to the device. The
location of the re-positionable clip 248 can be placed to allow the
physician to lock the location of the sealable acorn tip 245
outside of the vagina. To facilitate the re-positioning performed
by the physician, two sets of indicia can be provided. Distal
indicia indicated by 271, 272, and 273 in FIGS. 4a and 4b. More or
less distal indicia that provide a frame of reference for depth of
insertion are possible. Distal indicia 271, 272, and 273 indicate
the depth of insertion of distal end 205 within the uterine cavity
(not shown). Proximal indicia, 276, 277, and 278 can provide a
visual reference for the physician while the device 200 is inserted
inside the patient. Proximal indicia 276, 277, and 278 can remain
outside of the vagina as a result of its location on device 200 and
the length of outer catheter 240. The device can have more or less
proximal indicia that can provide an external frame of reference
for the physician.
[0042] Biopsy instillment 300 can have a bulbous, rounded,
tear-drop shaped, or ball tip 400 at its distal end at the distal
end 205 of device 200. The ball tip 400 can provide a less
traumatic leading surface of device 200, when the biopsy instrument
300 is retracted within the distal end 205 of the device 200, and
for the biopsy instrument 300 when the biopsy instrument 300 is
advanced beyond the distal end 205 when a biopsy is taken. The
proximal hemi-spherical section of ball tip 300 can have
fenestrations, grooves, or channels so that fluid from bag 230 can
be easily ejected from distal end 205 when the ball tip 400 is full
retracted within distal end 205.
[0043] FIG. 4a illustrates a handle 210 that can eject fluid from
bag 230 by the actuation of a lever 220 by pumping action that
takes lever 220 from Position A to Position B in a one handed
technique. There are several alternatives for this action including
the introduction of air or gas pressure with a CO2 cartridge or
pumping air pressure within the bag system through a separate check
valve (not shown). In addition, the fluid bag could be positioned
in a foot pedal system in which the physician can eject fluid by
depressing a foot actuated system (not shown). Other pump systems
or gravity feed systems are possible.
[0044] In FIGS. 4a and 4b, fluid bag 230 can be supplied prefilled
to the physician. In addition, at the proximal end of handle 210,
or anywhere on handle 210, a luer connector 600 is placed with
conduit 610 connected to fluid bag 230. With luer connector 600 and
conduit 610, the physician can add different or additional fluid
media or agents to fluid bag 230, for example when media is desired
for further diagnostic information, or if a new fluid agent, such
as a gel or foam, was desired for added visualization or the
application of a therapeutic agent, such as lidocaine, is desired
during a procedure.
[0045] In addition, the advancement or button 310 and subsequent
rotation of turn knob 312 can be controlled by a motor (not shown).
The addition of the motor would continue the desire to keep a
one-handed procedure without additional manipulations for the
physician. There would be cost benefits by not having a motor as
depicted in FIGS. 4a and 4b.
[0046] FIGS. 5a and 5b illustrate one configuration of an apparatus
for performing simultaneous sonography and biopsy that engages a
vaginal ultrasound probe 810 during a uterine cavity assessment
(uterine cavity not shown). During a procedure, gynecologists will
typically use a vaginal ultrasound probe for performing a
diagnostic assessment. In practice, this requires one hand of the
physician to be on the vaginal ultrasound probe 810 while the other
hand would be needed to remain on the handle 805 of device 800. One
mechanism to make this process easier for the physician is
illustrated in FIG. 5a with handle 805 in side view, and FIG. 5b
with handle 805 in top view. In both FIGS. 5a and 5b, rotatable,
repositionable, clip 815 is located on the distal portion of handle
805. Clip 815 contains arm projections 820 that are configured to
grasp and lock onto vaginal ultrasound probe 810. Arm projections
820 can contain indentations, grips, mechanical locks, magnets,
Velcro, or straps to maintain position of the vaginal ultrasound
probe 810 with handle 805.
[0047] An apparatus and method for performing simultaneous
ultrasonography, or radiographic visualization, and biopsy without
loss of visualization during the biopsy step is disclosed herein.
The apparatus is configured to perform both procedures with one
instrument and one hand position by the physician. The one hand
position can allow the physician to use his or her free hand to
stabilize the patient, operate ultrasound controls, or manipulate
another device or instrument without the requirement of additional
manpower. Being able to perform both procedures with only one
device insertion can reduce procedure time and cost for the
physician, patient, and payors.
[0048] The sealable acorn tip and outer catheter configuration with
re-positionable clip can be a separate device for mounting onto
traditional hysteroscopy sheaths and other devices utilized in
uterine cavity procedures.
[0049] The system described herein could be utilized as a platform
for the introduction of other materials and therapeutic agents into
the uterine cavity such as gels, foams, and contrast agents for
either echogenicity or radiographic visualization. Other
therapeutic agents can be applied through this platform including
sclerosing, contraception, and adhesion prevention agents.
Additional agents can include gametes, blastocysts, and other
biological products utilized in infertility procedures.
[0050] The biopsy instillment described herein could be replaced or
removed before or after use by another instrument such as a
polypectomy snare (with or without a coupling to an electrosurgical
energy source), biopsy cup, grasper, probe, endoscope, drug or
energy delivery device, or other instrument for a therapeutic or
diagnostic procedure. The biopsy instrument can be replaced by an
implant delivery device that provides permanent contraception
within the fallopian tube or uterine cavity.
[0051] The physician can locate the biopsy instrument at a targeted
region within the body cavity, for example by using ultrasonography
or radiographic visualization simultaneously with a biopsy
procedure. For gynecologic practice, physicians may want to target
certain regions of the uterus if atypical lesions or identified
with diagnostic visualization. Utilizing a biopsy instrument that
does not require vacuum pressure to withdraw tissue within the
distal end of the device allows for both of these procedures to be
performed simultaneously. Coupled with the use of a sealable acorn
tip that reforms within the endocervical canal at the exocervix
this procedure can reduce the amount of manpower, steps, or hands
required to perform the procedure. This is especially true since
endocervical canals are presented to the physician in a multitude
of shapes and configurations. They are not round and cylindrical
but instead in majority they are elliptical, irregular, and
unpredictable in shape and configuration.
[0052] In describing the method of performing simultaneous
ultrasonography, or radiographic examination, and biopsy, the
physician would prepare the vagina and cervix as per standard
technique. Typically the physician would take a scout film or
ultrasound view to distinguish anatomical landmarks. In some cases,
the length of the cervical canal and uterine cavity would be
determined. Alternatively, the physician may sound or measure the
length of the uterine cavity by retracting the sealable acorn tip
to its most proximal position prior to insertion through the cervix
and into the uterine cavity. If the length of the cervix and
uterine cavity is determined, and a depth of insertion into the
uterine cavity is calculated, the physician could then set the
re-positionable clip on the device to the desired length using the
indicia provided on the device. The device could be inserted into
the cervix until the sealable acorn tip engages the exocervix with
slight forward pressure. The bulging of the proximal pad area of
the sealable acorn tip can be visualized and felt with tactile
sensation. The trigger on the handle of the device can then be
released to open the conduit of the fluid bag to the distal end of
the device.
[0053] Alternatively, the physician may eject fluid out of the
distal end of the device while inserting the device through the
cervix to create a hydraulic distending action through the
endocervical canal and uterine cavity. Once positioned in the
uterine cavity with the sealable acorn tip engaged and reformed
into place at the exocervix, the physician can then pump additional
fluid, such as saline, into the uterine cavity to distend the
cavity and create room for visualization. Additional fluid may be
placed into the cavity for assessing patency in the fallopian tubes
and viewing other anatomical features. Additional fluid can be
inserted into the proximal luer connector and conduit that
facilitates the addition of extra fluid during a procedure. The
fluid bag can be pre-filled with an appropriate amount of fluid at
the start of a procedure. The physician can change the depth of
insertion of the device by opening and repositioning the clip if
necessary by utilizing the proximal indicia, which is visible
outside of the vagina, to re-position the distal end of the device.
The physician may wish to target the distal end of the device at or
near a region of interest inside the uterine cavity. The physician
can advance the button on the handle to advance the biopsy
instrument towards the region of interest. The rotatable turn knob
allows the physician to rotate and manipulate the biopsy components
in a fashion to collect, cut, grasp, or shave the tissue of
interest. On done, the physician can retract the button on the
handle to retract the biopsy instrument within the distal end of
the device. Then the physician can withdraw the entire device from
the patient. Once outside of the patient, the physician can place
the distal of the device into a specimen container and re-advance
the biopsy instrument within the specimen container. The physician
may elect to advance and retract the biopsy instrument several
times against the distal end of the device to further release
tissue contents collected on the biopsy components.
[0054] Materials and manufacturing techniques may be employed as
within the level of those with skill in the relevant art. The same
may hold true with respect to method-based aspects of the
disclosure in terms of additional acts commonly or logically
employed. Any optional feature of the variations described herein
may be set forth and claimed independently, or in combination with
any one or more of the features described herein. Reference to a
singular item includes the possibility that there are plural of the
same items present More specifically, as used herein, the singular
forms "a," "and," "said," and "the" include plural referents unless
the context clearly dictates otherwise. As such, this statement is
intended to serve as antecedent basis for use of such exclusive
terminology as "solely," "only" and the like in connection with the
recitation of claim elements, or use of a "negative" limitation.
Unless defined otherwise herein, all technical and scientific terms
used herein have the same meaning as commonly understood by one of
ordinary skill in the art. The breadth of the present disclosure is
not to be limited by the subject specification, but rather only by
the plain meaning of the terms employed.
[0055] All publications and patent applications mentioned in this
specification are herein incorporated by reference to the same
extent as if each individual publication or patent application was
specifically and individually indicated to be incorporated by
reference.
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