AU2017232035A1 - Method for treating organic erectile dysfunction - Google Patents

Abstract

Method For Treating Organic Erectile Dysfunction Abstract 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. COURSE OF EXTERNAL COUNTERPULSATION TREATMENTT TO PATIENT'S LOWER BODY 112, 200 210 COURSE OF LOW1 INTENSITY SHOCKWAVE (LISW) APPLIED TOI PENILE AREA COURSE OF CARBOXYL THERAPY TO CORPORA CAVERNOUS FIG . 2

Description

Field of the Invention [0001] The present invention relates to treatment methods and, more specifically, to a method for treating erectile dysfunction.

Description of the Related Art [0002] 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.

[0003] 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.

[0004] 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.

[0005] 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.

2017232035 18 Sep 2017 [0006] 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.

[0007] Therefore, there is a need for effective non-medical treatment of erectile dysfunction.

SUMMARY OF THE INVENTION [0008] The disadvantages of the prior art are overcome by the present invention which, in one aspect, relates to 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.

[0009] In another aspect, the invention relates to 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 (v) 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

2017232035 18 Sep 2017 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.

[0010] In yet another aspect, the invention relates to 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.

[0011] 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 FIGURES OF THE DRAWINGS [0012] FIG. 1 is a flow chart showing one embodiment of a method of treating ED.

[0013] FIG. 2 is a schematic diagram showing carbon dioxide injection sites.

[0014] FIG. 3 is a schematic diagram showing carbon dioxide injection into a corpus cavernosum.

DETAILED DESCRIPTION OF THE INVENTION [0015] 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. As used herein carboxy therapy means injecting carbon dioxide into the patient's corpora cavernosa.

[0016] 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

2017232035 18 Sep 2017 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.

[0017] The course of external counter-pulsation treatment includes applying external counterpulsation 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 mJmm² 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-A1, filed by Ein-Gal, discloses one method of low intensity shockwave treatment and is incorporated herein by reference for the purpose of disclosing 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.

[0018] 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 and is incorporated herein by reference for the purpose of disclosing counter-pulsation methods. 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 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.

[0019] 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 and is incorporated herein by reference for the purpose of disclosing methods of determining blood flow velocity. The ECP treatment is repeated until it achieves a predetermined resultant increase in blood flow.

2017232035 18 Sep 2017 (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.) [0020] As shown in FIG. 2, in the carboxy therapy, about 160 cc of carbon dioxide is injected into the corpora cavernosa 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 and is incorporated here by reference to disclose one device and method for administering carboxy therapy. 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 cavernosum 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 cavernosa. 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.

[0021] 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 cavernosa 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.

[0022] 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

2017232035 18 Sep 2017 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.

[0023] Throughout this specification, unless the context requires otherwise, the word comprise, or variations such as comprises or comprising, will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps.

[0024] Any discussion of documents, acts, materials, devices, articles or the like which has been included in the present specification is solely for the purpose of providing a context for the present invention. It is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the present invention as it existed before the priority date of each claim of this specification.

Claims (20)

1. A method of treating erectile dysfunction in a patient, comprising the steps of: (a) applying a predetermined course of external counter-pulsation treatment to a lower body portion of the patient; (b) after the step of applying a predetermined course of external counter-pulsation treatment, applying a predetermined course of low intensity shockwave treatment to a penile area of the patient; and (c) after the step of applying a course of low intensity shockwave treatment, applying a predetermined course of carboxy therapy to a corpora cavernosa of the patient.

2. The method of claim 1, wherein the step of applying a predetermined course of external counter-pulsation treatment comprises the step of applying external counter-pulsation treatments to the patient for a predetermined number of days per week for a predetermined number of weeks.

3. The method of claim 2, wherein the step of applying a predetermined course of external counter-pulsation treatments comprises the steps of:

(a) sensing an electrocardiogram (ECG) of the patient;

(b) applying an inflatable cuff to at least one of a calf, a lower thigh, an upper thigh and buttocks of the patient; and (c) applying a plurality of counter-pulsations to the cuff during events sensed by the ECG.

4. The method of claim 3, wherein the step of applying a plurality of counter-pulsations to the cuff comprises the steps of:

(a) during a diasotole sensed by the ECG, inflating the cuff to a predetermined pressure; and (b) during onset of a systole sensed by the ECG, rapidly releasing pressure from the cuff.

5.

The method of claim 3, wherein the predetermined pressure comprises about 300 mm Hg.

2017232035 18 Sep 2017

6. The method of claim 3, wherein the step of applying a plurality of counter-pulsations to the cuff is performed repeatedly during a treatment sessions that last about one hour performed five days per week over a course of four weeks.

7. The method of claim 3, further comprising the steps of:

(a) testing circulatory blood flow velocity in the patient; and (b) repeating the step of applying a predetermined course of external counter-pulsation treatment until the circulatory blood flow velocity flow is above a predetermined threshold.

8. The method of claim 1, wherein the step of applying a predetermined course of low intensity shockwave treatment comprises the step of performing a plurality of treatments that each include applying shock waves having a maximum energy of 0.09 mJmm to the penile area at a predetermined rate for a predetermined amount of time per treatment.

9. The method of claim 8, wherein plurality of treatments include one treatment per day for two to three days per week over a course of five weeks.

10. The method of claim 8, 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.

11. The method of claim 1, wherein the step of applying a predetermined course of carboxy therapy comprises injecting a predetermined amount of carbon dioxide into the corpora cavernosa of the patient at a plurality of sites along the patient's penile shaft.

12. The method of claim 11, wherein the course of carboxy therapy is performed twice per week, but 48 hours apart, for twelve consecutive weeks and wherein the predetermined amount of carbon dioxide comprises 160 cc.

13. The method of claim 11, wherein the plurality of sites comprises four sites, including two sites on each side of the patient's penile shaft.

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2017232035 18 Sep 2017

14. An erectile dysfunction treatment method, comprising the steps of:

(a) increasing major blood vessel flow 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, in which the predetermined course of external counter-pulsation treatments comprises the steps of:

(i) sensing an electrocardiogram (ECG) of the patient;

(ii) applying an inflatable cuff to at least one of a calf, a lower thigh, an upper thigh and buttocks of the patient;

(iii) applying a plurality of counter-pulsations to the cuff;

(iv) during a diasotole sensed by the ECG, inflating the cuff to a predetermined pressure; and (v) during onset of a systole sensed by the ECG, rapidly releasing pressure from the cuff;

(b) stimulating blood vessel growth 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; and (c) after the external counter-pulsation treatment step and after the low intensity shockwave treatment step, increasing pliability of a corpora cavernosa of the patient 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.

15. The erectile dysfunction treatment method of claim 14, wherein the predetermined pressure comprises about 300 mm Hg.

2017232035 18 Sep 2017

16. The erectile dysfunction treatment method of claim 14, wherein the step of applying a plurality of counter-pulsations to the cuff is performed repeatedly during a treatment sessions that last about one hour performed up to five days per week over a course of four weeks.

17. A treatment method for treating erectile dysfunction treatment in a patient, comprising the step of injecting a predetermined amount of carbon dioxide into the corpora cavernosa of the patent.

18. The method of claim 17, wherein the predetermined amount of carbon dioxide comprises about 160 cc.

19. The method of claim 17, wherein the carbon dioxide is injected at four different sites along the patient's penile shaft.

20. The method of claim 17, wherein the predetermined amount of carbon dioxide is injected twice per week, but 48 hours apart, for twelve consecutive weeks.