23. The device according to embodiment 22, wherein the one or more physiological parameters are selected from rigidity of the penis, tumescence of the penis, hardness of the penis, diameter of the penis, growth of the penis, duration of the erection, swelling time of the penis; preferably selected from hardness of the penis, diameter of the penis, rigidity of the penis and tumescence of the penis.

24. The device according to any one of the preceding embodiments, further comprising recording means configured to record the electrical signals from the transducer means.

25. The device according to any one of the preceding embodiments, further comprising control means being configured to be electrically connected to the transducer means for providing control to said transducer means.

26. The device according to any one of the preceding embodiments, further comprising interface means configured to provide communication with peripheral equipment.

27. The device according to embodiment 26 wherein the communication with peripheral equipment is a wire-less communication.

28. The device according to embodiment 26 wherein the communication with peripheral equipment is a wired communication.

29. A non-diagnostic method for measuring the rigidity and/or tumescence of a penis during a penile tumescent event, said method comprising:

- measuring the axial rigidity and/or tumescence of the penis;
- optionally measuring the radial rigidity and/or tumescence of the penis;
- calculating the overall rigidity and/or tumescence of the penis based on the measurements of the axial rigidity and/or tumescence of the penis optionally in combination with the measurements of the radial rigidity and/or tumescence of the penis.

30. A non-diagnostic method for monitoring one or more physiological parameters of a penis during a penile tumescent event with a device according to any one of the embodiments 1 to 28, said method comprising:

- positioning the axial monitoring means on the penis;
- optionally positioning the radial monitoring means around the penis;
- measuring the resistance of the at least two sensors in the axial monitoring means during a period of time;
- optionally measuring the resistance of the at least two sensors in the radial monitoring means during a period of time;
- monitoring the one or more physiological parameters by measuring the changes in resistance of the at least two sensors in the axial monitoring means over said period of time, optionally combined with the changes in resistance of the at least two sensors in the radial monitoring means over said period of time.

31. The non-diagnostic method of embodiment 30 wherein the one or more physiological parameters are selected from rigidity of the penis, tumescence of the penis, hardness of the penis, diameter of the penis, growth of the penis, duration of the erection, swelling time of the penis.

32. The non-diagnostic method of embodiment 30 or 31, further comprising generating the ratio of the resistance between the at least two sensors in the axial monitoring means and monitoring the one or more physiological parameters of the penis based on the ratio of the resistance between the at least two sensors in the axial monitoring means.

33. The non-diagnostic method of embodiment 32, further comprising generating the ratio of the resistance between the at least two sensors in the radial monitoring means and monitoring the one or more physiological parameters of the penis based on the ratio of the resistance between the at least two sensors in the radial monitoring means.

34. The method of any of the embodiments 29 to 33 further comprising measuring or evaluating other health parameters of the male subject.

BRIEF DESCRIPTION OF THE DRAWINGS

With specific reference now to the figures, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the different embodiments of the present invention only. They are presented in the cause of providing what is believed to be the most useful and readily description of the principles and conceptual aspects of the invention. In this regard no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention. The description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice.

FIGS. 1A-1C: Device for measuring the rigidity and tumescence of a penis according to an embodiment of the invention. The device according to the invention comprising axial monitoring means (1, 2) for monitoring the axial rigidity of the penis and optionally radial monitoring means (3, 4) for monitoring the radial rigidity of the penis. The device may further comprise a substrate (5) onto which the monitoring means are attached. (FIG. 1A) Axial monitoring means attached on the substrate; (FIG. 1B) radial and axial monitoring means attached on the substrate of the device according to an embodiment of the invention. (FIG. 1C) In a particular embodiment, the device according to the invention comprises a peripheral equipment, such as a sensor node and a wired communication between the monitoring means of the device and said peripheral equipment.

FIG. 2: Measurement principle to measure tumescence and rigidity with a device according to the invention.

FIG. 3: Expected time measurement when measuring tumescence and rigidity.

FIG. 4: Fold out substrate and axial and radial monitoring means of the device as displayed in FIGS. 1A and 1B. In this embodiment, the monitoring means are textile strips that are attached to the substrate at their ends. W: width; L: length

FIG. 5 Artificial penis as used in the experiments for performing axial and/or radial measurements in a test setting.

FIG. 6: Sensor placement during real-time rigidity measurements on a human penis. Sensors are placed in the axial and/or radial direction on the penis.

FIG. 7: Axial rigidity measurement. The resistance values increase linear with the applied pressure.

FIG. 8: Axial rigidity measurement. In the last pressure step, the strip with elasticity 2 starts to saturate.

FIG. 9: Axial rigidity measurement. The sensor E2 has reached the end of its operation range and is saturated. Sensor E1 still increases linearly with increasing pressure but in the first step the pressure is not high enough for this strip to deform.

FIG. 10: Axial rigidity measurement. Sensor E2 is completely saturated and will not monitor the rigidity anymore.

FIG. 11: Radial rigidity measurement. The sensor E2 has reached the end of its operation range and is saturated. Sensor E1 still increases linearly with increasing pressure.

FIG. 12: Real-time measurement of axial rigidity. The erecting and relaxing penis can be observed.

FIG. 13: An erection cycle measured for the axial rigidity. Performing linear fits on the ascending and descending edges gives information about the speed, the penis erects or relaxes.

FIG. 14: Real-time measurement of radial rigidity. The erecting and relaxing of the penis can be observed.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides a device (100) for measuring the rigidity and tumescence of a penis. Said device comprises axial monitoring means (1, 2) for monitoring the axial rigidity of the penis and optionally also radial monitoring means (3, 4) for monitoring the radial rigidity of the penis, wherein the axial monitoring means and optionally the radial monitoring means each comprise at least two sensors with a different elasticity to each other (FIG. 1). In a specific embodiment, the axial monitoring means and the radial monitoring means are each at least two sensors with a different elasticity to each other.

In a further aspect, the different sensors of the device of the present invention each comprise one or more semi-conductive or conductive means, such as for example semi-conductive or conductive wires or tracks.

The device of the present invention is typically characterized in that it allows the monitoring of the axial rigidity and tumescence of the penis. Therefore, the axial monitoring means are configured to be applied in the axial direction on the penis. Whereas in the device currently described in the prior art only radial measurements are executed, the device of the present invention is typically characterized by its axial measurements. The invention therefore not only provides a user-friendly device but also introduces new possibilities such as measuring the speed at which an erection occurs and evaluating the erection in the total length of the penis and not only at one location in the penis. Further, the device of the present invention allows monitoring of the physiological parameters of the penis on a continuous basis and not only at regular intervals. To this end, the device comprises axial monitoring means. In a further embodiment, the axial monitoring means are configured to be applied in the axial direction on the penis.

In another embodiment, the device of the present invention is typically characterized in that it allows the monitoring of both the axial and radial rigidity and tumescence of the penis. Therefore, in this embodiment, both axial and radial monitoring means are present in the device, which allows the simultaneous monitoring of both the axial and radial rigidity and tumescence of the penis. The device according to this embodiment of the present invention is thus typically characterized in that it allows monitoring of the penile rigidity wherein a distinction is made between axial and radial rigidity, and wherein both types of rigidity are combined in the final measurement of the penile rigidity and tumescence. The combination of monitoring both axial rigidity and radial rigidity of the penis in one single device not only provides a user-friendly device but also introduces new possibilities such functional analysis of the penis using both axial and radial rigidity data.

In still another further embodiment, the radial monitoring means are configured to be applied in the radial direction around the penis. Thus, in an embodiment, the device of the present invention comprises axial monitoring means that are configured to be applied in the axial direction on the penis and radial monitoring means that are configured to be applied in the radial direction around the penis.

As can be observed in FIG. 2, in one embodiment of the invention, the at least two sensors with different elasticity of the axial monitoring means are separated from one another across the width of the penis. In another embodiment, the at least two sensors of the radial monitoring means extend over the length of the penis.

Typical for the invention is also that the at least two sensors of the radial and/or axial monitoring means have a different elasticity to each other. In a further embodiment, said sensors comprise conductive or semi-conductive means that deform when the sensors are subjected to an external applied force, i.e. when the erection of the penis occurs. As deformation of the sensors takes place, the resistance value of the sensor changes linearly with the exerted force. The at least two sensors further have a certain operation range. Within the operation range, the resistance value will change linearly with the applied external force. When the senor is at the end of its operation range, the conductive wire is completely stretched. The resistance value will no longer change with an increasing deformation and further stretching of the sensor will result in damage.

The at least two sensors of the axial and/or radial monitoring means have thus a different elasticity to each other. For each type of rigidity (axial or radial), at least two sensors, such as sensor strips, are used, each with a different elasticity. One sensor has a high elasticity and will deform as the penis swells due to blood filling of the erectile tissue (tumescence). The other sensor has a lower elasticity and will deform as the penis gets more rigid (rigidity). When the sensors are in their initial state, no force is exerted on the sensors and no deformation takes place. The resistance values will not change over time, and hence also to ratio of both the axial and radial resistance values will be constant. When the penile erection starts, a force will be exerted and the sensors of both the axial and radial monitoring means will start to deform. As both sensors have a different elasticity, the deformation of the sensors with the highest elasticity will be greater than the deformation of the sensor with the lowest elasticity (also see FIG. 2). Due to the deformation, a change in resistance values takes will take place. When the penis swells, but is still not rigid, only the sensor with the highest elasticity will deform, and tumescence can be measured. When both sensors are deforming, this indicates that the penis is now also getting rigid, and then penile rigidity can be determined by calculating the ratio of these values. For example, FIG. 3 shows a measurement over time. When the penis swells but does not get rigid, only the sensor with the highest elasticity will deform resulting in measuring tumescence. When the penis becomes rigid, both sensors will deform and penile rigidity can be measured.

The sensors and/or the semi-conductive or conductive means of the device of the present invention can be of any material, for example textile, rubber, plastic or nylon.

The present invention is now further illustrated using the following figures.

FIGS. 1A-1C represent the device according to some embodiments of the invention. In one of the embodiments (FIG. 1A), the device of the present invention comprises axial monitoring means (1, 2) for monitoring the axial rigidity of the penis wherein said monitoring means are attached to a substrate. In another embodiment (FIG. 1B) the device comprises axial monitoring means (1, 2) for monitoring the axial rigidity of the penis and radial monitoring means (3, 4) for monitoring the radial rigidity of the penis, and wherein said axial and radial monitoring means are attached to a substrate.

In a further aspect, the device of the present invention comprises transducer means configured to transduce the changes in hardness and diameter of the penis into electrical signals.

The device of the present invention may further comprise control means that are configured to be electrically connected to the transducer means for providing control to said transducer means.

The device further also comprises a peripheral equipment, such as a sensor node and a wired or wireless communication between the monitoring means of the device and the peripheral equipment. In a further embodiment, the sensor node can be a home-made sensor node or a commercially available sensor node, such as for example a Byteflies® node.

In another embodiment, the wired communication between the monitoring means and the peripheral equipment is made via any suitable connection that allows the measurement of changes in resistance, either directly or via Wheatstone bridge circuit. In still another and specific embodiment, the connection between the monitoring means and the peripheral equipment such as the sensor node is made via a flexible printed circuit board. In still another embodiment, the communication between the monitoring means and the peripheral equipment is wireless.

In still another aspect, the device further comprises interface means being configured to provide communication with peripheral equipment.

The device according to the present invention is thus configured to be in communication with a peripheral equipment. Said communication can be a wire-less communication or a wired communication, such as described in FIG. 1C.

In a particular embodiment, and as displayed in FIG. 4, the substrate of the device is a sheet, in particular a quadrangle. In a further embodiment, and as also described in FIG. 4, the radial monitoring means and/or the axial monitoring means are attached to the substrate with their ends.

In a particular aspect, the device according to the invention thus comprises:

- axial monitoring means for monitoring the axial rigidity of the penis;
- optionally radial monitoring means for monitoring the radial rigidity of the penis;
- a substrate;
- transducer means configured to transduce the changes in hardness and diameter of the penis into electrical signals;
- recording means configured to record the electrical signals from the transducer means;
- control means being configured to be electrically connected to the transducer means for providing control to said transducer means;
- interface means configured to provide communication with peripheral equipment;
- wherein the axial monitoring means and optionally the radial monitoring means each comprise at least two sensors with a different elasticity or resistance to each other.

The present invention also provides a method for measuring the rigidity and/or tumescence of a penis during a penile tumescent event. In a particular aspect, said method is a non-diagnostic method that can be executed by a non-medically trained person, for example by the subject or patient itself. Said method comprises measuring the axial rigidity and/or tumescence of the penis, optionally measuring the radial rigidity and/or tumescence of the penis, calculating the overall rigidity and/or tumescence of the penis based on the measurements of the axial rigidity and/or tumescence of the penis and optionally the radial rigidity and/or tumescence of the penis.

In another embodiment, the invention provides a method for measuring one or more physiological parameters of a penis during a penile tumescent event with a device according to any one of the embodiments of this invention. In a further aspect, this method is a non-diagnostic method, in particular a non-diagnostic method that can be executed by a non-medically trained person, for example by the patient or subject itself. Said method comprising positioning the axial monitoring means on the penis, optionally positioning the radial monitoring means around the penis, measuring the resistance of the at least two sensors in the axial monitoring means during a period of time and optionally in the radial monitoring means, monitoring of the one or more physiological parameters by measuring the changes in resistance of the at least two sensors in said monitoring means over said period of time. In a further embodiment, said method comprises calculating the ratio of the resistance between the at least two sensors in the axial monitoring means, and measuring the one or more physiological parameters of the penis based on the ratio of the resistance between the at least two sensors in the axial monitoring means. In a further embodiment, the ratio of the resistance between the at least two sensors in the radial monitoring means is calculated and used in combination with the ratio of the axial monitoring means to measure the one or more physiological parameters of the penis. In a further aspect, said one or more physiological parameters of the penis are further selected from rigidity of the penis, tumescence of the penis, hardness of the penis, diameter of the penis, growth of the penis, duration of the erection, swelling time of the penis. In a preferred embodiment, said physiological parameters are selected from hardness of the penis and diameter of the penis. In another preferred embodiment, said physiological parameters are selected from the rigidity of the penis and the tumescence of the penis.

EXAMPLES

A. Measuring Device

The measuring device used in the present examples represents a possible embodiment of a device according to the present invention. The device comprises axial or radial monitoring means that each comprise two sensors with a different elasticity to each other. In the device as used herein, the sensors are textile sensors that are used to monitor the penile rigidity. They consist of stretchable strips that contain a conductive wire which deforms when the textile sensor is subjected to an externally applied force. As deformation takes place, the resistance value of the sensor changes linearly with the exerted force. The sensors as used in the present device have a certain operation range that must be taken into account while performing the measurements. Within the operation range the resistance value will change linearly with the applied external force. When the sensor is at the end of its operation range, the conductive wire is completely stretched. The resistance value will no longer change with an increasing deformation and further stretching of the sensor will result in damage.