WO2020191000A1 - Erectile dysfunction treatment methods - Google Patents

Abstract

Devices and methods for treating male sexual health conditions include the use of penile traction devices. For example, this document describes devices and methods for treating erectile dysfunction by applying longitudinal and/or lateral penile traction forces.

Description

ERECTILE DYSFUNCTION TREATMENT METHODS

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application Serial No. 62/820,476, filed March 19, 2019. The disclosure of the prior application is considered part of (and is incorporated by reference in) the disclosure of this application.

BACKGROUND

1. Technical Field

This document relates to devices and methods for treating sexual health conditions. For example, this document relates to devices and methods for treating erectile dysfunction by applying longitudinal and/or lateral penile traction forces.

2. Background Information

Erectile dysfunction (impotence) is the inability to get and keep an erection firm enough for sex. Erectile dysfunction is relatively common, affecting an estimated 18 million men in the U.S. alone.

Many men who have had a prostatectomy (surgical removal of all or a portion of the prostate gland) experience erectile dysfunction to varying degrees as a result of the procedure.

The International Index of Erectile Function (IIEF)- Erectile Function Domain (EFD) score is a multi-factor evaluation tool that is used for quantifying the severity of an individual’s erectile function/dysfunction and consists of items 1-5 and 15 from the IIEF. The IIEF-EFD scoring system is a measurement means that can establish a reliable baseline, and that can be used to monitor changes related to treatment.

SUMMARY

This document describes devices and methods for treating sexual health conditions. For example, this document describes devices and methods for treating erectile dysfunction by applying longitudinal and/or lateral penile traction forces.

In a first aspect, this disclosure is directed to a method of treating erectile dysfunction (ED). The method includes selecting a patient having an IIEF-EFD score of 16 or lower, or 25 or lower, and treating the patient using penile traction therapy (pH) j^ p_{TT com}p_nses applying one or more types of traction force to a penis of the patient using a PTT device.

Such a method may optionally include one or more of the following features. In some embodiments, the patient previously had a prostatectomy that negatively affected the patient’s IIEF-EFD score. Alternatively, in some cases the cause of the selected patient’s ED is irrelevant. In some cases, six months of the treating may result in an improvement of the patient’s IIEF-EFD score of at least 4.0, or at least 1.0. In some embodiments, when selected, the IIEF-EFD score of the patient was 11 or lower, and six months of the treating results in an improvement of the patient’s IIEF-EFD score of at least 6.0. The one or more types of traction force may consist of longitudinal traction force. The one or more types of traction force may include lateral bending traction force. The one or more types of traction force may include concurrent application of longitudinal traction force and lateral bending traction force.

In another aspect, this disclosure is directed to a method of treating ED. The method includes selecting a patient after prostatectomy and having an IIEF-EFD score of 16 or lower, and treating the patient using PTT. The PTT includes applying one or more types of traction force to a penis of the patient using a PTT device.

Such a method may optionally include one or more of the following features. Six months of the treating may result in an improvement of the patient’s IIEF-EFD score of at least 4.0. Six months of the treating may result in a greater improvement of the patient’s IIEF-EFD score than six months of treating. In some embodiments, when selected, the IIEF-EFD score of the patient was 11 or lower, and six months of the treating results in an improvement of the patient’s IIEF-EFD score of at least 6.0. The one or more types of traction force may consist of longitudinal traction force.

The one or more types of traction force may include lateral bending traction force.

The one or more types of traction force may include concurrent application of longitudinal traction force and lateral bending traction force.

Particular embodiments of the subject matter described in this document can be implemented to realize one or more of the following advantages. In some embodiments, ED can be treated using PTT. Such treatments can result in clinically- meaningful results. For example, in patient populations having moderate ED (an IIEF-EFD score from 11 to 16), in some cases an improvement in the patient’s IIEF- EFD score of at least 4.0 can be achieved after six months of PTT. In patient populations having mild ED (an IIEF-EFD score of 17-25), in some cases an improvement in the patient’s IIEF-EFD score of at least 2.0 can be achieved after six months of PTT. In patient populations having severe ED (an IIEF-EFD score less than 11), in some cases an improvement in the patient’s IIEF-EFD score of at least 6.0 or at least 7.0 can be achieved after six months of PTT. PTT has also been found to be an effective treatment for ED after prostatectomy.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Although methods and materials similar or equivalent to those described herein can be used to practice the invention, suitable methods and materials are described herein. All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the present specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.

The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description herein. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.

DESCRIPTION OF THE DRAWINGS FIG. 1 is a graph showing the results of the methods disclosed herein of using penile traction therapy for three months to treat erectile dysfunction in accordance with some embodiments provided herein.

FIG. 2 is a graph showing the results of the methods disclosed herein of using penile traction therapy for six months to treat erectile dysfunction m accordance with some embodiments provided herein.

Like reference numbers represent corresponding parts throughout.

DETAILED DESCRIPTION

This document describes devices and methods for treating sexual health conditions. For example, this document describes devices and methods for treating ED by applying longitudinal and/or lateral penile traction forces (i.e., PTT using a penile traction device). With reference to FIG. 1, a graph 100 illustrates the results of 3-months of PTT when applied to four different populations of male patients. The four different populations of male patients include: (i) patients with severe ED 110, (ii) patients with moderate ED 120, (lii) patients with mild ED 130, and (iv) patients with no ED 140. The graph 100 also includes an“overall” population 150 that includes all of the four populations combined.

The patients with severe ED 110 had a pre-treatment IIEF-EFD score of less than 11. The patients with moderate ED 120 had a pre-treatment IIEF-EFD score of 11-16. The patients with mild ED 130 had a pre-treatment IIEF-EFD score of 17-25. The patients with no ED 140 had a pre-treatment IIEF-EFD score of 26-30.

The results of PTT of each of the populations 110, 120, 130, 140, and 150 are shown in two sub-populations. The two sub-populations are: (i) patients that were treated with PTT (the left column of each population) and (ii) a“control” sub population of patients that were not treated with PTT (the right column of each population).

For example, the patients with severe ED 110 includes a first sub-population 110a that was treated using PTT, and a second sub-population 110b that was not treated using PTT. Similarly, the population of patients with moderate ED 120 include a first sub-population 120a that was treated using PTT, and a second sub population 120b that was not treated using PTT. Likewise, the population of patients with mild ED 130 includes a first sub-population 130a that was treated using PTT, and a second sub-population 130b that was not treated using PTT. Similarly, the population of patients with no ED 140 includes a first sub-population 140a that was treated using PTT, and a second sub-population 140b that was not treated using PTT.

The overall population 150 includes a first sub-population 150a that was treated using PTT, and a second sub-population 150b that was not treated using PTT. The first sub-population 150a is simply a total compilation of the first sub -populations 110a, 120a, 130a, and 140a. Similarly, the second sub-population 150b is a total compilation of the second sub -populations 110b, 120b, 130b, and 140b.

PTT treatment was applied to the first sub-populations 110a, 120a, 130a, and 140a. As part of the experiment for which the results are depicted in graph 100, the PTT treatment was administered using a PTT device known as RestoreX^® (available from PathRight Medical, Inc. of Plymouth, Minnesota). The PTT treatment was administered in accordance with the instructions for use of the RestoreX^® device. However, the treatment methods described herein are not limited to the use of the RestoreX^® device exclusively, nor to the instructions for use for the RestoreX® device exclusively. That is, other PTT techniques and/or devices can be used for the performance of the ED treatment methods described herein.

The graph 100 illustrates that PTT is an effective treatment ED. Moreover, as shown in the graph 100, patients with more severe ED experienced greater benefits from the PTT as compared to patients with lesser severities of ED. For example, the graph 100 shows that the IIEF-EFD scores of the first sub-population 110a of the patients with severe ED 110 experienced a substantial improvement of 6.9 units on average in their IIEF-EFD scores. In comparison, the graph 100 shows that the IIEF- EFD scores of the first sub-population 120a of the patients with moderate ED 120 experienced a still-significant improvement of 4.3 units on average in their IIEF-EFD scores. Whereas, the IIEF-EFD scores of the first sub-population 130a of the patients with mild ED 130 experienced a less-significant improvement of 1.5 units on average in their IIEF-EFD scores. In each case, the second sub-populations 110b, 120b, and 130b experienced essentially no change in their average IIEF-EFD scores (as expected).

With reference to FIG. 2, a graph 200 illustrates the results of the four different populations of male patients (from FIG. 1) after six months of PTT. It can be seen that the results after six months are even better than after three months (FIG. 1).

In another part of the study performed by the inventor, nine (9) men who had some degree of ED were treated for three months, and then six months (total), using PTT. The IIEF-EFD scores of those nine (9) men increased from an average baseline of 17.3 to an average of 20.3 after six months of PTT. For those with severe ED (<11 IIEF-EFD), there were 13 men, and they increased 7.8 points on average. There were seven men with moderate ED (1 1-16), and they improved 8.4 points on average.

There were 10 men with mild ED (17-25) who improved 2.3 points on average.

The inventor also performed a study directed specifically to patients that underwent a prostatectomy. The pre-prostatectomy and post-prostatectomy IIEF- EFD scores of fifteen (15) men were tracked. Of those fifteen (15) men, nine (9) of them went through post-prostatectomy PTT. The other six (6) men (as a control population) did not go through any post-prostatectomy PTT. After PTT (e.g., five months of PTT starting one month after prostatectomy surgery), the nine (9) men exhibited an average drop in their IIEF-EFD score of only 4.3 (comparing post-prostatectomy versus pre-prostatectomy). However, the IIEF- EFD scores the six (6) men that did not go through any post-prostatectomy PTT dropped by 1 1.8 on average (comparing post-prostatectomy versus preprostatectomy). The results of this study suggests a protective role of PTT in men undergoing prostatectomy to prevent worsening of erectile function.

In regard to devices for administering PTT, the disclosure of U.S. Patent Application Serial Number 16/307,802 is hereby incorporated by reference in its entirety for all purposes. Accordingly, one or more of the PTT device designs and/or design features described in the context of the penile traction devices disclosed in U. S. Patent Application Serial Number 16/307,802 can be used for the ED treatment methods described herein.

In some embodiments, the devices for treating ED by applying PTT are configured to concurrently apply longitudinal and lateral traction forces. In some embodiments, the devices for treating ED by applying PTT are configured to apply longitudinal traction forces only (without lateral traction forces).

In some embodiments, the devices for treating ED by applying PTT are configured for applying progressive mechanical traction. That is, the devices are adjustable (including self-adjustable) so as to progressively add traction forces to allow for gradual and on-going ED treatment adjustments and improvements. In some embodiments, the PTT devices used for the methods described herein are configured to exert traction forces that are readily adjustable. Hence, definitive treatment plans can be ordered and implemented, thereby potentially enhancing patient results.

In some embodiments, the devices for treating ED by applying PTT are configured to be worn comfortably and discreetly. In some embodiments, the devices for treating ED by applying PTT can be used advantageously in conjunction with a pharmacological agent as part of a treatment plan for ED and other conditions. In some embodiments, the traction force(s) applied are dynamic loads. That is, as the penis stretches in response to the traction force(s), additional traction force(s) continue to be applied. This is in contrast to stretching and holding the traction force(s) applicators (e.g., clamp) at a fixed location(s). While this specification contains many specific implementation details, these should not be construed as limitations on the scope of any invention or of what may be claimed, but rather as descriptions of features that may be specific to particular embodiments of particular inventions. Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination. Moreover, although features may be described herein as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a subcombination or variation of a subcombination.

Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. In certain circumstances, multitasking and parallel processing may be advantageous. Moreover, the separation of various system modules and components in the embodiments described herein should not be understood as requiring such separation in all embodiments, and it should be understood that the described program components and systems can generally be integrated together in a single product or packaged into multiple products.

Particular embodiments of the subject matter have been described. Other embodiments are within the scope of the following claims. For example, the actions recited in the claims can be performed in a different order and still achieve desirable results. As one example, the processes depicted in the accompanying figures do not necessarily require the particular order shown, or sequential order, to achieve desirable results. In certain implementations, multitasking and parallel processing may be advantageous.

Claims

WHAT IS CLAIMED IS:

1. A method of treating erectile dysfunction (ED), the method comprising:

selecting a patient having an International Index of Erectile Function (IIEF)- Erectile Function Domain (EFD) score of 16 or lower; and

treating the patient using penile traction therapy (PTT), wherein the PTT comprises applying one or more types of traction force to a penis of the patient using a PTT device.

2. The method of claim 1, wherein the patient previously had a prostatectomy that negatively affected the patient’s IIEF-EFD score.

3. The method of claim 1 or 2, wherein six months of the treating results in an improvement of the patient’s IIEF-EFD score of at least 4.0.

4. The method of claim 1 or 2, wherein, when selected, the IIEF-EFD score of the patient was 1 1 or lower.

5. The method of claim 4, wherein six months of the treating results in an improvement of the patient’s IIEF-EFD score of at least 6.0.

6. The method of any one of claims 1 through 5, wherein the one or more types of traction force consists of longitudinal traction force.

7. The method of any one of claims 1 through 5, wherein the one or more types of traction force includes lateral bending traction force.

8. The method of any one of claims 1 through 5, wherein the one or more types of traction force includes concurrent application of longitudinal traction force and lateral bending traction force.

9. A method of treating erectile dysfunction (ED), the method comprising:

selecting a patient after prostatectomy and having an International Index of Erectile Function (IIEF)-Erectile Function Domain (EFD) score of 16 or lower; and treating the patient using penile traction therapy (PTT), wherein the PTT comprises applying one or more types of traction force to a penis of the patient using a PTT device.

10. The method of claim 9, wherein six months of the treating results in an improvement of the patient’s IIEF-EFD score of at least 4.0.

11. The method of claim 9 or 10, wherein, when selected, the IIEF-EFD score of the patient was 1 1 or lower.

12. The method of claim 1 1, wherein six months of the treating results in an improvement of the patient’s IIEF-EFD score of at least 6.0.

13. The method of any one of claims 9 through 12, wherein the one or more types of traction force consists of longitudinal traction force.

14. The method of any one of claims 9 through 12, wherein the one or more types of traction force includes lateral bending traction force.

15. The method of any one of claims 9 through 12, wherein the one or more types of traction force includes concurrent application of longitudinal traction force and lateral bending traction force.

16. A method of treating erectile dysfunction (ED), the method comprising:

selecting a patient having: (i) an International Index of Erectile Function (IIEF)-Erectile Function Domain (EFD) score of 25 or lower, or (ii) with inability to achieve or maintain an erection satisfactory for penetrative intercourse; and

treating the patient using penile traction therapy (PTT), wherein the PTT comprises applying one or more types of traction force to a penis of the patient using a PTT device.

17. The method of claim 16, wherein the one or more types of traction force consists of longitudinal traction force.

18. The method of claim 16, wherein six months of the treating results in an improvement of the patient’s IIEF-EFD score of at least 2.0.