Note: Descriptions are shown in the official language in which they were submitted.
USE OF A COMBINATION OF COUNTER-PULSATIONS, LOW INTENSITY SHOCK
WAVES AND CARBON DIOXIDE FOR TREATING ORGANIC ERECTILE
DYSFUNCTION
Field of the Invention
The present invention relates to the use of a combination of external counter-
pulsations, low
intensity shock waves and carbon dioxide for treating erectile dysfunction in
a patient.
Description of the Related Art:
Erectile dysfunction (ED) is a condition in which the patient is unable to
achieve or sustain an
erection suitable for sexual intercourse. Physical causes for ED include
illness, medications, injury
and poor blood flow to the corpora cavernosa of the patient's penis.
Treatments for ED include medications and physical treatments designed to
increase blood flow
to the corpora cavernosa. Medical treatments include phosphodiesterase type 5
(PDE5) inhibitors,
such as sildenafil, tadalafil and vardenafil. These medications tend to
stimulate generation of cyclic
guanosine monophosphate (cGMP) in smooth muscle cells, thereby relaxing the
smooth muscle,
which increases blood flow to the corpora cavernosa.
Non-invasive physical treatments include external counter-pulsation (ECP)
therapy to the legs of
the patient. ECP involves applying pneumatic cuffs to the patient's thighs and
buttocks and
monitoring the patient's heart rate and rhythm. The cuffs inflate and deflate
based on the patient's
heart rhythm, in which the cuffs inflate at the beginning of diastole and
deflate at the beginning of
systole. Typically, the cuffs are inflated to about 200-300 mmHg. This
generally increases overall
cardiac output, which increases blood flow to the corpora cavernosa. However,
this treatment is
effective for only a limited number of patients.
Another physical treatment includes applying low intensity shock waves to the
patient's penile
area. These treatments are designed to stimulate tissue to promote the growth
of smaller blood
vessel around the corpora cavernosa. However, use of this treatment by itself
has had limited
effectiveness.
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While medical treatments can be effective for certain patients, the
medications can interact with
other drugs and can have undesirable side effects. Physical treatments tend to
have limited
effectiveness.
Therefore, there is a need for effective non-medical treatment of erectile
dysfunction.
Summary of the invention:
The disadvantages of the prior art are overcome by the present invention
which, in one aspect, is
the use of a combination of a predetermined course of external counter-
pulsations, a predetermined
course of low intensity shock waves and an amount of carbon dioxide for
treating erectile
dysfunction in a patient, wherein:
the predetermined course of external counter-pulsations is adapted to be
provided
to a lower body portion of the patient;
the predetermined course of low intensity shock waves is adapted to be
provided to
a penile area of the patient, and
the amount of carbon dioxide is adapted to be injected into a corpora
cavernosa of
the patient.
According to a preferred embodiment, the predetermined course of external
counter-pulsations
comprises the use of an electrocardiogram, also named ECG, of the patient
combined with the use
of an inflatable cuff located to at least one of a calf, a lower thigh, an
upper thigh and buttocks of
the patient; the counter-pulsations to the cuff being sensed by the ECG. The
cuff may be configured
to inflate to a predetermined pressure when a diastole is sensed by the ECG;
and the cuff is
configured to deflate for rapidly releasing pressure during onset of a systole
sensed by the ECG.
The predetermined pressure when the diastole is sensed by the ECG is
preferably about 300 mm
Hg. The external counter-pulsations are preferably configured to be repeated
until a circulatory
blood flow velocity is above a predetermined threshold.
According to a preferred embodiment, each of the low intensity shock waves has
a maximum
energy of 0.09 mJmm2, the low intensity shock waves being configured to be
applied to to the
penile area at a predetermined rate for a predetermined amount of time. The
predetermined rate is
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preferably about 300 pulses per minute and wherein the predetermined amount of
time is within a
range of 10 minutes and 20 minutes.
According to a preferred embodiment, the amount of carbon dioxide is a
predetermined amount
configured to be injected into the corpora cavemosa of the patient at a
plurality of sites along the
patient's penile shaft. The predetermined amount of carbon dioxide is
preferably about 160cc. The
plurality of sites comprises four sites, including two sites on each side of
the patient's penile shaft.
These and other aspects of the invention will become apparent from the
following description of
the preferred embodiments taken in conjunction with the following drawings. As
would be obvious
to one skilled in the art, many variations and modifications of the invention
may be effected
without departing from the spirit and scope of the novel concepts of the
disclosure.
Brief description of the drawings:
FIG. 1 is a flow chart showing one embodiment of a method of treating ED.
FIG. 2 is a schematic diagram showing carbon dioxide injection sites.
FIG. 3 is a schematic diagram showing carbon dioxide injection into a corpus
cavemosum.
Description of embodiments
A preferred embodiment of the invention is now described in detail.
Referring to the drawings, like numbers indicate like parts throughout the
views. Unless otherwise
specifically indicated in the disclosure that follows, the drawings are not
necessarily drawn to
scale.
As used in the description herein and throughout the claims, the following
terms take the meanings
explicitly associated herein, unless the context clearly dictates otherwise:
the meaning of "a," "an,"
and "the" includes plural reference, the meaning of "in" includes "in" and
"on".
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As used herein "carboxy therapy" means injecting carbon dioxide into the
patient's corpora
cavernosa.
As used herein "about" means that the value of weight %, time, pressure,
energy or temperature
can vary within a certain range depending on the margin of error of the method
or device used to
evaluate such weight %, time, pressure, energy or temperature. A margin of
error of 10% is
generally accepted.
As aforesaid, the present invention concerns the use of a combination of a
predetermined course
of external counter-pulsations, a predetermined course of low intensity shock
waves and an amount
of carbon dioxide for treating erectile dysfunction (ED) in a patient.
As shown in FIG. 1, in one embodiment of a treatment method for ED, a course
of external counter-
pulsation (ECP) is applied to the lower body portions of the patient 110. A
course of low intensity
shockwave (LISW) therapy is applied to the patient's penile area 112. Next,
carboxy therapy is
applied to the patient's corpora cavernosa 114.
The course of external counter-pulsation treatment includes applying external
counter-pulsation
treatments to the patient for a predetermined number of days per week for a
predetermined number
of weeks. In the low intensity shockwave treatment (LISW), shock waves having
a maximum
energy of 0.09 mimm2 are applied with a local applicator to the penile area
once per day for two
or three days per week over a course of five weeks. U.S. Publication No. US-
2015/0073312-A ,
filed by Ein-Gal, discloses one method of low intensity shockwave treatment.
In a typical treatment, about 300 pulses are applied per minute over the
course of between 10
minutes and 20 minutes. The LISW treatment stimulates neovascularization and
improves penile
blood flow and endothelial function when applied to the corpora cavernosa.
In applying the course of external counter-pulsation treatments an
electrocardiogram (ECG)
sensing device is applied to the patient and the ECG is sensed. U.S. Pat. Nos.
7,314,478 and
7,314,478, both issued to Hui, disclose a counter-pulsation apparatus and
method for controlling
the apparatus. An inflatable cuff is applied to at least one of the patient's
calf, lower thigh, upper
thigh or buttocks. Typically, cuffs are applied to both of the lower thighs
and to both of the upper
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thighs. Counter pulsations are applied to the cuffs by inflating the cuffs to
a pressure of about 300
mm Hg during a diastole sensed by the ECG. Pressure is then rapidly released
from the cuffs during
onset of the systole, as sensed by the ECG. Counter-pulsations are performed
repeatedly during a
treatment sessions that last about one hour, which are performed five days per
week over a course
of four weeks.
Circulatory blood flow velocity in the patient is tested both before and after
the ECP treatment,
typically with a duplex Doppler. U.S. Pat. No. 6,251,076, issued to Hovland et
al., discloses one
method of determining blood flow velocity in a penile artery. The ECP
treatment is repeated until
it achieves a predetermined resultant increase in blood flow. (While the
threshold necessary to
move past ECP treatments is a matter of the individual treating physician's
judgment, it is typically
a doubling in blood flow through the major blood vessels near the groin.)
(Also, it should be noted
that the term "ECP" is sometimes confused with "EECP," which is a registered a
trademark for a
brand of ECP. However, the EECP brand can be employed as the type of ECP
used.)
As shown in FIG. 2, in the carboxy therapy, about 160 cc of carbon dioxide is
injected into the
corpora eavernosa of the patient, typically at four different sites 210 along
the patient's penile shaft
200. U.S. Pat. No. 9,132,245, issued to Mantell, discloses a carboxy therapy
application. The
injections are performed with a micro-injection carboxy therapy applicator
310, as shown in FIG.
3, that injects the carbon dioxide into each corpus cavemosum 302 in the
patient's penis 300. This
is typically performed twice per week, but about 48 hours apart, for twelve
consecutive weeks.
The carboxy therapy infuses carbon dioxide into the tissues, causing the body
to interpret the
presence of the carbon dioxide as an oxygen deficiency, which results in the
production of vascular
endothelial growth factors in the tissues. This encourages vascular growth and
local reduction in
fat tissue, which results in increased blood flow to the corpora cavemosa. It
is important to begin
the carboxy therapy after the ECP and the LISW treatments, which could cause
the carbon dioxide
to disperse at an undesirable rate and, thereby reduce its effectiveness.
One embodiment treats ED with the carboxy therapy disclosed above and without
the LISW and
ECP treatments. It has been found that injecting carbon dioxide directly into
the corpora cavemosa
CA 2980053 2017-09-25
can have a substantial effect by itself Similarly, in some cases, only carboxy
treatment to the
corpora cavernosa without both, or either, LISW or ECP treatment may be used
to treat ED.
The present invention also concerns a method of treating erectile dysfunction
in a patient, in which
a predetermined course of external counter-pulsation treatment is applied to a
lower body portion
of the patient. After the predetermined course of external counter-pulsation
treatment is applied, a
predetermined course of low intensity shockwave treatment is applied to a
penile area of the
patient. After the course of low intensity shockwave treatment, a
predetermined course of carboxy
therapy is applied to a corpora cavernosa of the patient.
In another aspect, the invention is an erectile dysfunction treatment method,
in which major blood
vessel flow is increased with external counter-pulsation treatment to a lower
body portion of a
patient by applying external counter-pulsation treatments to the patient for a
predetermined
number of days per week for a predetermined number of weeks. The predetermined
course of
external counter-pulsation treatments comprises the steps of:
sensing an electrocardiogram (ECG) of the patient;
applying an inflatable cuff to at least one of a calf, a lower thigh, an upper
thigh and
buttocks of the patient;
applying a plurality of counter-pulsations to the cuff during a diasotole
sensed by the ECG,
inflating the cuff to a predetermined pressure; and
during onset of a systole sensed by the ECG, rapidly releasing pressure from
the cuff.
Blood vessel growth is stimulated in a penile area of the patient with low
intensity shockwave
treatment of the penile area of the patient by performing a plurality of
treatments that each include
applying shock waves having a maximum energy of 0.09 mJmm2 to the penile area
at a
predetermined rate for a predetermined amount of time per treatment, wherein
plurality of
treatments include one treatment per day for two to three days per week over a
course of five weeks
and wherein the predetermined rate is about 300 pulses per minute and wherein
the predetermined
amount of time per treatment is within a range of between 10 minutes and 20
minutes.
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After the external counter-pulsation treatment and after the low intensity
shockwave treatment,
pliability of a corpora cavernosa of the patient is increased with carboxy
treatment by injecting
about 160 cc of carbon dioxide into the corpora cavernosa at four different
sites along the shaft of
patient's penis twice per week, but 48 hours apart, for twelve consecutive
weeks.
In yet another aspect, the invention is a treatment method for treating
erectile dysfunction treatment
in a patient, in which a predetermined amount of carbon dioxide is injected
into the corpora
cavernosa of the patent.
The above described embodiments, while including the preferred embodiment and
the best mode
of the invention known to the inventor at the time of filing, are given as
illustrative examples only.
It will be readily appreciated that many deviations may be made from the
specific embodiments
disclosed in this specification without departing from the spirit and scope of
the invention.
Accordingly, the scope of the invention is to be determined by the claims
below rather than being
limited to the specifically described embodiments above.
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