U.S. patent application number 16/681075 was filed with the patent office on 2020-05-14 for treatment of pelvic organ prolapse.
The applicant listed for this patent is Remendium Labs LLC. Invention is credited to Ramon Jose IGLESIAS.
Application Number | 20200146800 16/681075 |
Document ID | / |
Family ID | 48905780 |
Filed Date | 2020-05-14 |
United States Patent
Application |
20200146800 |
Kind Code |
A1 |
IGLESIAS; Ramon Jose |
May 14, 2020 |
TREATMENT OF PELVIC ORGAN PROLAPSE
Abstract
The present invention relates to the diagnosis and treatment of
pelvic floor prolapse. The diagnosis and treatment may involve the
use of a multiple sensor-enabled device for vaginal insertion
capable of providing real-time data regarding the patient's
physiology, the position and movement of the urethra, and the
muscular strength of the patient's vagina and pelvic floor. The
methods and devices of the invention may also be useful to
addressing other medical issues, including urinary incontinence,
sexual health, and fecal incontinence, as well as facilitate
patient home wellness activities.
Inventors: |
IGLESIAS; Ramon Jose;
(DeLeon Springs, FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Remendium Labs LLC |
Baton Rouge |
LA |
US |
|
|
Family ID: |
48905780 |
Appl. No.: |
16/681075 |
Filed: |
November 12, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14374314 |
Jul 24, 2014 |
10470862 |
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PCT/US2013/023806 |
Jan 30, 2013 |
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16681075 |
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61592092 |
Jan 30, 2012 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/0045 20130101;
A61B 2562/0247 20130101; A61B 5/227 20130101; A61B 5/4848 20130101;
A61B 5/103 20130101; A61B 5/4337 20130101; A61B 5/6847
20130101 |
International
Class: |
A61F 2/00 20060101
A61F002/00; A61B 5/00 20060101 A61B005/00; A61B 5/22 20060101
A61B005/22; A61B 5/103 20060101 A61B005/103 |
Claims
1. A method for the diagnosis or treatment of pelvic organ prolapse
comprising providing a device for vaginal insertion in a patient
comprising at least one sensor capable of providing real-time data
of one or more types selected from the group consisting of
position, movement, pressure, and flow, and determining the
anatomical state of the patient capable of relieving the
prolapse.
2. The method of claim 1 further comprising manipulating the
patient to relieve the prolapse.
Description
BACKGROUND OF THE INVENTION
[0001] The present invention relates to the diagnosis and treatment
of pelvic organ prolapse and related conditions. The diagnosis and
treatment may involve the use of a multiple sensor-enabled device
for vaginal insertion capable of providing real-time data regarding
the patient's physiology, the position and movement of the urethra,
and the muscular strength of the patient's vagina and pelvic
floor.
[0002] Pelvic organ prolapse (POP) generally relates to a condition
where the muscles and ligaments supporting a woman's pelvic organs
weaken thereby causing the pelvic organs to slip out of place
(prolapse). There are different types of POP, including vaginal
vault prolapse, bladder prolapse, rectal prolapse, uterine
prolapse, and small bowel prolapse. Some women develop vaginal
prolapse, usually after menopause, childbirth or a
hysterectomy.
[0003] In certain cases, POP occurs due to the damage of the
tissues that support the intra-abdominal contents causing the
contents of the abdominal cavity to spill through the weakest
support points and extrude through the vaginal walls. This weakness
can be at the bladder area, the uterine area or the
rectal/enterocele area. The condition can worsen over time, and the
patient may need corrective surgery.
[0004] Information regarding the anatomical areas of weakness
suspected as contributing to the condition as well as the primary
area of weakness can facilitate appropriate corrective surgery at
an early stage and in a targeted fashion to repair the herniated
abdominal contents through the pelvic floor area. In addition,
specially designed patches, for example, could be used to prevent
further prolapse.
[0005] Presently, there is no available test that can accurately
diagnose POP by localizing and evaluating the herniated areas
suspected of giving rise to a patient's POP. The types of
diagnostic tests commonly relied upon today include the cotton swab
test (where the health care provider inserts a small, cotton-tipped
applicator lubricated with anesthetic gel into the patient's
urethra, the patient is asked to strain, and the applicator may
indicate a loss of support to the urethra); the bladder function
test (to measure the ability of the patient's bladder to store and
empty urine, which might aid the health care provider to determine
the most appropriate type of surgery for bladder or urethral
prolapse); pelvic floor strength tests (where the health care
provider relies upon personal experience to approximate the
strength of the patient's pelvic floor and sphincter muscles, and
possibly, the strength of muscles and ligaments that support the
patient's vaginal walls, uterus, rectum, urethra and bladder); and
imaging tests (which include magnetic resonance imaging (MRI) to
obtain a three-dimensional image of the pelvis; ultrasound to
visualize the patient's kidneys, bladder or the muscles around the
patient's anus; cystoscopy to evaluate symptoms of urinary urgency,
frequency, bladder pain or blood in the urine by insertion of a
thin tube with a light and camera on the tip (cytoscope) into the
patient's urethra to view the urethra and bladder. None of these
techniques, however, alone or collectively, can provide the
positional and pressure data to yield as detailed and accurate POP
diagnosis as possible through the instant invention.
[0006] Furthermore, there is evidence that pelvic floor training
can strengthen the pelvic floor muscles to remedy or otherwise
alleviate urinary incontinence (UI) and POP, and thereby avoid
surgery. Present methods for pelvic floor training, however, do not
offer a way for the health care provider or the patient to measure
improvement, confirm that such exercises are being performed
correctly, or to accurately monitor the amount of time the patient
is doing the exercises and amount of exertion the patient is using
in order to improve or prevent UI or POP.
[0007] The multiple sensor-enabled device disclosed here can assist
the health care provider and the patient to assess whether the
patient is properly performing Kegel exercises and otherwise
achieving the therapeutic goals.
[0008] Physical therapists today employ certain electronic devices
to help the patient perform Kegel exercises. In these cases, a
vaginal insert with sensors may be viewed as electrical impulses on
a screen. But these devices cannot reflect what muscles the patient
is contracting, indicate whether the patient is contracting the
appropriate muscles, or monitor the patient's progress.
Essentially, the only information readout is a tracing that
reflects the discharge of electrical stimuli, but which offers no
assurance to the health care provider or patient that the needed
strengthening of the pelvic floor muscles is occurring. Electrical
stimulation might provide temporary relief of UI if the electrical
impulses happen to be engaged and placed correctly. However,
because it is difficult, if not impossible, to know the amount of
electrical discharge needed and the correct positioning, these
methods do not work effectively or long-term. The electrical
stimulation might allow the patient to recognize their own muscles,
but falls short of facilitating the strengthening of the patient's
muscles to result in an improvement, because the patient must also
contract the particular muscles properly.
[0009] The multiple sensor-enabled device of the instant invention
would allow the health care provider and the patient to visualize
whether the patient is actually doing the pelvic floor exercises
correctly. Moreover, educating the patient on the correct way of
using the device would allow the patient to take the device with
her, and in the privacy of her home, visualize her exercise regimen
through a convenient display, such as a computer or smart phone
application. The patient may also benefit from inserting, removing
and cleaning the device at her convenience. Furthermore, the
patient can monitor and record her progress and send her
information back to the health care provider to assure her
compliance. The convenience and privacy of home training and
progress monitoring can enhance patient compliance with the
therapeutic regimen, and facilitate a more efficient achievement of
therapeutic goals.
BRIEF SUMMARY OF THE INVENTION
[0010] The present invention relates to the diagnosis and treatment
of pelvic organ prolapse (POP). In an embodiment of the invention,
this diagnosis and treatment involves the use of a multiple
sensor-enabled device for vaginal insertion capable of providing
real-time data regarding the patient's physiology, the position and
movement of the urethra, and the muscular strength of the patient's
vagina and pelvic floor. In one embodiment, the device may be
inflatable.
[0011] The multiple sensor-enabled device may include at least one
sensor capable of providing real-time data of one or more types
selected from the group consisting of position, movement, pressure,
and flow. In this regard, a sensor may have a single measurement
and reporting capability, or may have multiple measurement and
reporting capabilities.
[0012] The present invention also includes a method for the
diagnosis or treatment of urinary incontinence (UI) or POP
comprising providing a multiple sensor-enabled device in a patient
and determining the anatomical state of the patient capable of
relieving the incontinence. The device can indicate the position of
the patient's urethra and vagina, and allow the health care
provider or patient to visualize the relative movement of these
anatomical organs, and thus, show the patient whether her efforts
at performing Kegel exercises are being performed correctly.
[0013] Often, the proper performance of Kegel exercises is
difficult to explain and difficult for the patient to understand
how to achieve. If the patient misunderstands how to perform such
exercises, she can perform them wrong, usually by performing a
valsalva maneuver and consequently causing more damage to the
pelvic floor by causing the abdominal contents to be pushed down
through the pelvic floor.
[0014] The multiple sensor-enabled device of the present invention
would also enable the health care provider and patient to view
quantitatively what vaginal pressure is being exerted by the
patient at any time, to recognize the vaginal muscular strength,
and to facilitate the patient's performance of muscular exercises
in a precise manner. The position and pressure of the posterior
vaginal wall as well as that of the lower intestines and rectal
area can be determined using the device.
[0015] In an embodiment of the present invention, where the device
includes Inflatable components as shown in FIG. 1 as an example,
POP could also be alleviated or prevented by placing the device
into the vagina and inflating each section from farthest to the
most proximal. The most proximal inflatable section may be inflated
to prevent spillage of the vaginal contents. In this mode of
operation, the device offers advantages over devices, such as
pessaries, used today. Every month, rather than the patient having
to return to the health care provider to extract the pessary and
clean it for reinsertion, the patient would be able to withdraw the
instant device and clean it for reinsertion in the convenience and
privacy of her own home, which may include any location outside the
health care provider's office or facility. In this regard, the
device disclosed here may be used to improve a woman's vaginal
muscular strength by performing vaginal strengthening exercises
(VSE) to achieve her desired sexual health as well as to address
any UI or POP conditions.
[0016] The present invention contemplates the real-time position
and movement tracking described in International Patent Application
PCT/US2010/053712, and the multiple sensor-enable device described
in U.S. provisional patent application Ser. No. 61/563,889, which
are hereby incorporated in their entirety by reference. In this
regard, the real-time position and movement tracking may include
sensing the position of the anatomical organ of interest to an
anatomical reference point, such as the patient's pubic bone, the
coccyx or the vagina, or to an external reference point, such as a
target on a patient's garment or in the patient's surroundings. The
method may be performed in real-time, for example, during a medical
examination, procedure, or surgery. In another embodiment, the
method may be performed at multiple time intervals. The multiple
time intervals may occur, for example, pre- and post-event, wherein
the event may be pregnancy or menopause.
[0017] The multiple sensor-enabled device may also provide pressure
data, which reflects muscular strength, and provide a health care
provider a detailed map of where the weakest anatomical points are
for purposes of POP diagnosis and treatment. Where vaginal
strengthening exercises are inadequate to prevent or relieve UI or
POP, a surgeon would be able to use this information to target
corrective procedures appropriately.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] FIG. 1 depicts a lateral view of an embodiment of the
present invention including pressure sensors 10, positional sensors
20, inflatable compartments 30, graphical user interface 40, and a
mark for patient to correctly position the device. Inflatable cells
start inflating from 1-5. Line of location sensors are positioned
on top row so that it is visible on the outside of the woman's
body. Pressure sensors are on 4 quadrants of each inflatable
cell.
DETAILED DESCRIPTION OF THE INVENTION
[0019] When used in the claims, the terms "a" and "an" and "the"
and similar references in the context of describing the invention
(especially in the context of the following claims) are to be
construed to cover both the singular and the plural, unless
otherwise indicated herein or clearly contradicted by context. Also
when used in the claims, the terms "comprising," "having,"
"including," and "containing" are to be construed as open-ended
terms (i.e., meaning "including, but not limited to,") unless
otherwise noted. To the extent used, the recitation of ranges of
values herein are merely intended to serve as a shorthand method of
referring individually to each separate value falling within the
range, unless otherwise indicated herein, and each separate value
is incorporated into the specification as if it were individually
recited herein. All methods described herein can be performed in
any suitable order unless otherwise indicated herein or otherwise
clearly contradicted by context. The use of any and all examples,
or exemplary language (e.g., "such as") provided herein, is
intended merely to better illuminate the invention and does not
pose a limitation on the scope of the invention unless otherwise
claimed. No language in the specification should be construed as
indicating any non-claimed element as essential to the practice of
the invention. Variations of the embodiments may become apparent to
those of ordinary skill in the art upon reading the description.
Accordingly, this invention includes all modifications and
equivalents of the subject matter recited in the claims appended
hereto as permitted by applicable law. Moreover, any combination of
the described elements in all possible variations thereof is
encompassed by the invention unless otherwise indicated herein or
otherwise clearly contradicted by context.
[0020] For purposes of the present invention, the term "urethra"
may be defined as the canal leading from the bladder, discharging
the urine externally. See STEDMAN's MEDICAL DICTIONARY, at page
2072 (28.sup.th ed). In females, the urethra is a canal about 4
centimeters long passing from the bladder, in close relation with
the anterior wall of the vagina and having a long axis that
parallels that of the vagina opening in the vestibule of the vagina
posterior to the clitoris and anterior to the vaginal orifice. Id.
The term "urinary bladder" refers to a musculomembranous elastic
bag serving as a storage place for the urine, filled via the
ureters and drained via the urethra. Id. at page 226. The term
"bladder neck" is defined as the smooth muscle of the bladder neck
is histologically, histochemically and pharmacologically distinct
from the detrusor muscle proper and so the bladder neck should be
considered as a separate functional unit. See GRAY's ANATOMY, at
page 1290 (39.sup.th ed.). The arrangement of smooth muscle in this
region is quite different in males and females, and therefore each
sex is described separately. In females, the bladder neck consists
of morphologically distinct smooth muscle. The large diameter
fasciculi characteristic of the detrusor is replaced in the region
of the bladder neck by small diameter fasciculi which extend
obliquely or longitudinally into the urethral wall. Id. In the
normal female the bladder neck which above the pelvic floor
supported predominantly by the pubovesical ligaments, the
endopelvic fascia of the pelvic floor and levator ani. These
support the urethra at rest; with elevated intra-abdominal pressure
the levators contract increasing urethral closure pressure to
maintain continence. This anatomical arrangement commonly alters
after parturition and with increasing age, such that the bladder
neck lies beneath the pelvic floor, particularly when the
intra-abdominal pressure rises. The mechanism described above may
fail to maintain continence (incontinence as a result of urethral
hypermobility).
[0021] As commonly understood, the term "vagina" refers to an
elastic muscular canal that extends from the cervix to the vulva.
Although there is wide anatomical variation, the length of the
unaroused vagina of a woman of child-bearing age is approximately 6
to 7.5 cm (2.5 to 3 inches) across the anterior wall (front), and 9
cm (3.5 inches) long across the posterior wall (rear). The vagina
connects the superficial vulva to the cervix of the deep uterus. In
a typical woman standing upright, the vaginal tube points in an
upward-backward direction and forms an angle of slightly more than
45 degrees with the uterus. The vaginal opening is at the caudal
end of the vulva, behind the opening of the urethra. The upper
one-fourth of the vagina is separated from the rectum by the
recto-uterine pouch.
[0022] In the present invention, for example, a device for vaginal
insertion may be equipped with at least one sensor capable of
providing real-time data of one or more types selected from the
group consisting of position, movement, pressure, and flow. In this
regard, a sensor may have a single measurement and reporting
capability, or may have multiple measurement and reporting
capabilities. The data obtained by the multiple sensor-enabled
device may be reported in any number of ways known in the art,
including the transmission to, and visualization on, a graphical
user interface wirelessly.
[0023] The device would be inserted into the vagina until the
patient feels her cervix. The distal section of the device, in an
inflatable embodiment, would be filled with air, gel, liquid, or
other appropriate material suitable for inflation and deflation of
a compartment, to fit the patient's vagina. In an embodiment with
multiple inflatable sections, the rest of the compartments could be
filled from distal to proximal (vaginal opening). In this way, a
patient with POP not only would strengthen her vaginal muscles but
could also use the device as a pessary that can be easily removed
at home and would not have the complications currently associated
with pessaries, such as pressure point problems and vaginal
infections.
[0024] When the device is properly inserted and inflated, the
health care provider or patient can visualize the device on a
display screen. When the patient is asked to perform Kegel
movements, the vaginal pressure or strength of the vaginal
musculature will also be visualizable on the screen. The health
care provider could then go through the exercises with the patient
to ensure that she is performing the exercises optimally and has
understood how to interpret the information and otherwise use the
equipment properly.
[0025] The multiple sensor-enabled device would be invaluable as a
study or rehabilitation tool for the health care provider as well
as the patient who is considering a pregnancy. The health care
provider may be able to provide the patient with an exercise
regimen that could strengthen her vagina and urinary musculature at
home before she had her baby, helping her prevent urinary
incontinence in the future and strengthening her pelvic floor,
before the possible damage may occur during pregnancy and
delivery.
[0026] The multiple sensor-enabled device could aid various
diagnoses that rely upon data concerning the position, strength and
pressures of the vaginal space. By combining pressure sensors along
the multiple sensor-enabled inflatable vaginal insert along with
the positional sensors, objective measurements relating to vaginal
pressure and positional location can be evaluated and correlated to
aid in the diagnosis and treatment of UI or POP and the
rehabilitation of the vaginal muscles and pelvic floor.
[0027] In yet another embodiment of the present invention, the
multiple sensor-enabled device can provide data, which is
transmitted and recorded in a manner to create and maintain
historical patient information for medical and/or fitness purposes,
such as a pelvic floor muscle strengthening exercise calendar.
[0028] Another use for a multiple sensor-enabled device would be to
correct fecal incontinence, which is often another sequela of
pregnancy and childbirth. For example, if a rectocele or enterocele
is diagnosed, a multiple sensor-enabled device could be inserted
into the rectum. With this information the health care provider
would be able to properly diagnose the etiology of the fecal
incontinence whether that is due to muscle weakness of the pelvic
floor, a rectal sphincter deficiency, or a combination of the two.
The health care provider could target the surgical repair, in
real-time if preferred, to correct the fecal incontinence.
[0029] The multiple sensor-enabled device may incorporate at least
one sensor capable of measuring and/or reporting data of various
types including position, movement, pressure and flow. A multiple
sensor-enabled device with more than one individual sensor may be
arrayed as depicted in FIG. 1. However, a multiple sensor-enabled
device may incorporate a single sensor capable of multiple
measurement and reporting capabilities.
[0030] The position and movement data may be of the sort measured
and/or reported by any number of sensor devices, including an
accelerometer, gyroscope, inductive non-contact position sensor,
string potentiometer, linear variable differential transformer,
potentiometer, capacitive transducer, Eddy-current sensor, Hall
effect sensor, optical proximity sensor, piezo-electric transducer
and photodiode array. The position and movement data may also
include magnetic, electromagnetic, microelectromechanical, radio
frequency, ultrasound and video.
[0031] The pressure and flow data may be of the sort measured
and/or reported by any number of sensor devices, including force
collector types, such as piezo-resistive, capacitive,
electromagnetic, piezo-electric, optical, potentiometric, or other
types, such as resonant, thermal, ionization, ultrasonic, and
density (mass and index of refraction). In addition, sensor
technology that recognizes movement and touch may be incorporated,
which includes the types such as resistive, surface acoustic wave,
capacitive (surface capacitance, projected capacitance, mutual
capacitance, and self-capacitance), infrared, optical imaging,
dispersive signal technology, and acoustic pulse recognition.
[0032] FIG. 1 depicts a multiple sensor-enable device for vaginal
insertion with inflatable compartments. The number and precise
placement of an individual sensor may vary depending on the type of
positional, movement, pressure or flow measurement and/or reporting
system employed. An individual sensor may have a single function or
be multifunction (such as positional tracking combined with
pressure and flow sensing). The multiple sensor-enabled device may
also embody a video observation and/or recording device as well as
an illumination source to facilitate such video capture. The
precise placement of the sensor(s) and video capture component(s)
need not be pre-defined, and may be configured according to the
requirements of the desired application.
Specific Examples
[0033] As described earlier, the devices of the present invention
may embody at least one sensor capable of measuring and reporting
at least one data type, including position, movement, pressure, and
flow. These include, but are not limited to, magnetic,
electromagnetic, microelectromechanical, radio frequency,
ultrasound and video. One example of a multiple sensor-enabled
device contains various microelectromechanical (MEMS) sensors: a
3-axis accelerometer, a roll/pitch gyroscope and a yaw rate
gyroscope, and a pressure and flow transducer. The sensors may be
mounted on a small flexible printed circuit board (PCB) and then
attached to, or incorporated within, the device. The 3-axis
accelerometer tracks translation of the device in three directions.
The gyroscopes are utilized to account for gravitational rotation,
allowing real-time movement to be tracked.
[0034] A PCB is prepared with MEMS sensors mounted thereon. Soft
leads can trail the MEMS sensors to supporting components,
including, for example, a data acquisition card which may be used
for transforming analog signals to digital signals. The PCB is set
within the wall of the device. The location of the device may be
determined by the output signals of the MEMS sensors.
[0035] In an embodiment where the multiple sensor-enabled device
contains inflatable compartments, the device may be inserted in the
length of the vagina at which point the compartment nearest the
cervix is inflated to obtain a stationary and/or comfortable fit
within the vagina. Any additional inflatable compartments may be
inflated together or in sequence from distal to proximal to the
vaginal opening.
[0036] The patient may be asked to perform a Kegel movement, while
the health care provider and/or the patient observes the display
output to confirm that the patient is performing the exercise
optimally. The pressure and muscular strength of the vagina as
measured by the multiple sensor-enable device would be displayed to
reflect the effectiveness of the therapy. The position of the
urethra and bladder neck may also be displayed in real time on a
graphical user interface and/or recorded.
[0037] Following the examination using the multiple sensor-enabled
device, the health care provider may conclude that rehabilitation
is an efficacious option for the patient. In this regard, the
measurements provided by the multiple sensor-enabled device may be
recorded to facilitate appropriate patient instructions on
performing Kegel exercises in an optimal manner using the visual
(on-screen) information provided by the device in real-time. Once
engaging the proper musculature has been successfully communicated
to the patient during the medical office visit, the patient may be
sent home with the instructions to perform Kegel exercises five to
six times daily, for example. Four to six weeks later the patient
may return for another examination using the multiple
sensor-enabled device to evaluate rehabilitative treatment
effectiveness, which may allow the health care provider to advise
the patient about the prospects for restoring complete continence
with a continued rehabilitation regime and/or a surgical
procedure.
[0038] Detailed embodiments of the present invention are disclosed
herein; however, it is to be understood that the disclosed
embodiments are merely exemplary of the invention that may be
embodied in various forms. It will be appreciated that many
modifications and other variations that will be appreciated by
those skilled in the art are within the intended scope of this
invention as claimed below without departing from the teachings,
spirit and intended scope of the invention.
* * * * *