CA2980053A1 - Use of a combination of counter-pulsations, low intensity shock waves and carbon dioxide for treating organic erectile dysfunction - Google Patents

Use of a combination of counter-pulsations, low intensity shock waves and carbon dioxide for treating organic erectile dysfunction Download PDF

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Publication number
CA2980053A1
CA2980053A1 CA2980053A CA2980053A CA2980053A1 CA 2980053 A1 CA2980053 A1 CA 2980053A1 CA 2980053 A CA2980053 A CA 2980053A CA 2980053 A CA2980053 A CA 2980053A CA 2980053 A1 CA2980053 A1 CA 2980053A1
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Prior art keywords
patient
predetermined
pulsations
carbon dioxide
use according
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CA2980053A
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French (fr)
Inventor
Steven Morganstern
Carlos Becerra
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Bmr Medical LLC
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Bmr Medical LLC
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Priority to CA2980053A priority Critical patent/CA2980053A1/en
Publication of CA2980053A1 publication Critical patent/CA2980053A1/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/41Devices for promoting penis erection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/225Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for for extracorporeal shock wave lithotripsy [ESWL], e.g. by using ultrasonic waves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316Modalities, i.e. specific diagnostic methods
    • A61B5/318Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/346Analysis of electrocardiograms
    • A61B5/349Detecting specific parameters of the electrocardiograph cycle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/48Other medical applications
    • A61B5/4836Diagnosis combined with treatment in closed-loop systems or methods

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  • Health & Medical Sciences (AREA)
  • Reproductive Health (AREA)
  • Nursing (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Percussion Or Vibration Massage (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

It is disclosed 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. 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.

Description

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.

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
2 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".
3 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
4 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 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.

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.

Claims (10)

WHAT IS CLAIMED IS:
1. 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.
2. Use according to claim 1, wherein 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.
3. Use according to claim 2, wherein the cuff is 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.
4. Use according to claim 3, wherein the predetermined pressure when the diastole is sensed by the ECG is about 300 mm Hg.
5. Use according to any one of claims 2 to 4, wherein the external counter-pulsations are configured to be repeated until a circulatory blood flow velocity is above a predetermined threshold.
6. Use according to any one of claims 1 to 5, wherein each of the low intensity shock waves has a maximum energy of about 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.
7. Use according to claim 6, wherein the predetermined rate is about 300 pulses per minute and wherein the predetermined amount of time is within a range of 10 minutes and 20 minutes.
8. Use according to any one of claims 1 to 7, wherein the amount of carbon dioxide is a predetermined amount configured to be injected into the corpora cavernosa of the patient at a plurality of sites along the patient's penile shaft.
9. Use according to claim 1, wherein the predetermined amount of carbon dioxide is about 160cc.
10. Use according to claim 8 or 9, wherein the plurality of sites comprises four sites, including two sites on each side of the patient's penile shaft.
CA2980053A 2017-09-25 2017-09-25 Use of a combination of counter-pulsations, low intensity shock waves and carbon dioxide for treating organic erectile dysfunction Pending CA2980053A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2980053A CA2980053A1 (en) 2017-09-25 2017-09-25 Use of a combination of counter-pulsations, low intensity shock waves and carbon dioxide for treating organic erectile dysfunction

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CA2980053A CA2980053A1 (en) 2017-09-25 2017-09-25 Use of a combination of counter-pulsations, low intensity shock waves and carbon dioxide for treating organic erectile dysfunction

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CA2980053A1 true CA2980053A1 (en) 2019-03-25

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