Device for prostate palpation

Abstract

It consists of a system for palpation of the rectal face of the prostate that transforms the information collected into objective, reproducible and useful information. The system makes it possible to identify areas of high rigidity reaching the entire peripheral area, transforming a diagnostic maneuver for prostate cancer into an objective one, which until now has been subjective and unreliable. All this in a short space of time, carried out in a less aggressive and more objective way than rectal examination. The device consists of a manual electronic instrument with a handle (1) and a scanning rod (3), which includes at least two concentric force/pressure sensors of different heights, as well as an ultrasonic imaging system which, through means of connection to external devices for analysis/control, allows the data obtained to be analyzed and the anatomy of the prostate being analyzed to be visualized in real time.

Claims

1. A device for prostate palpation, comprising: a handle for handling of said device, and a probe comprising: (a) a force/pressure sensing means comprising at least two concentric force/pressure sensors acting on two concentric indenters of different heights; positioned proximal to a distal end of a scanning rod; (b) an ultrasonic imaging system located inside the scanning rod that allows visualization of location of said at least two concentric force/pressure sensors and prostate anatomy for correct positioning of the at least two concentric force/pressure sensors in and adjacent to a cancerous area so that measurements are valid; and (c) control electronics for both the at least two concentric force/pressure sensors and the ultrasonic imaging system with means of connection to external devices for analysis and/or control.

2. The device for prostate palpation according to claim 1, wherein the handle comprises a push button for activating the reading of the at least two concentric force/pressure sensors of the device, sa scale for displaying different pressure levels, and indicator lights.

3. The device for prostate palpation according to claim 1, wherein the force/pressure sensing means take the form of said at least two concentric indenters comprising a central indenter and an external or perimeter indenter, said central indenter being higher than the external or perimeter indenter, and each of which are linked a responsive one of said force/pressure sensors which are internal, the external or perimeter indenter being linked by means of a lever and the central indenter by means of a cylinder.

4. The device for prostate palpation according to claim 1, wherein the ultrasonic imaging system is embodied in a set of transmitters/receivers with different relative phases, involving at least 8 elements with a central frequency of at least 2 MHz, bandwidth of at least 50%, which focuses in such a way that a sectorial section of the prostate can be observed, and electronics associated with a wireless communications module or USB connection with a computer, a tablet, a smartphone or other computer device that allows the visualization ofti ultrasound information.

5. The device for prostate palpation according to claim 1, comprising several pairs of pressure/force sensors.

6. The device for prostate palpation according to claim 1, comprising a sheath covering the concentric indenters.

7. The device for prostate palpation according to claim 1, comprising a retraction system internal to the scanning rod.

Description

DESCRIPTION OF THE DRAWINGS

[0045] In order to complement the description to be given below and in order to help a better understanding of the features of the invention, in accordance with a preferential example of practical implementation of the same, a set of drawings is attached as an integral part of this description, in which the following is illustrated for illustrative purposes and without limitation:

[0046] FIG. 1 shows a perspective view of a device for prostate palpation made in accordance with the object of the present invention.

[0047] FIG. 2 shows an enlarged detail of the control interface located on the handle of the device.

[0048] FIG. 3 shows the position of the pressure sensors, located in the mechanical assembly formed by the support base and the hinged lever at the end of the base (raised in the figure). The left sensor (10 in the figure) receives the force from the inner indenter directly; the inner sensor (11 in the figure) receives the force from the outer indenter indirectly, through the central support of the lever where this second indenter is located.

[0049] FIG. 4 shows the indenter and sensor base assembly, mounted in its working position, which is inserted into the scanning rod (3) at its distal end and closed by a rounded cap (4). It has a support base for the sensors (12). The outer indenter (5) is integrated in a lever (13), hinged at its end on the base, and transmits the force to the corresponding sensor (11), by means of a central support (14). The inner indenter (6) passes through the inside of the outer indenter (5), being of greater overall height, and transmits the force to the corresponding sensor (10).

PREFERRED EMBODIMENT OF THE INVENTION

[0050] In view of the figures shown above, it can be seen that the device for prostate palpation disclosed consists of a hand-held electronic instrument, equipped with a handle (1) for its operation, and a probe (3).

[0051] More specifically, the control electronics are integrated in the handle, with a cover (2) for access to it, so that it has a pushbutton (7) for managing the device (on or off; activation or deletion of readings), as well as a scale (8) on which the different pressure levels (9) are displayed, and may include indicator lights (10) to show the measurement results, the power on of the equipment or the state of charge of the battery, all as can be seen in FIG. 2.

[0052] Returning again to FIG. 1, in proximity to its distal end (4) of the scanning rod (3) there are two concentric indenters (5-6) of different heights, the central one being higher than the external or perimeter one, the latter having a diameter of about 5 millimeters, The latter having a diameter of around 5 millimeters, elements by means of which pressure is applied to the exploration point, and which are linked to the respective internal pressure/force sensors by means of a lever (external indenter) and a cylinder (internal indenter).

[0053] In order to be able to visualize the anatomy of the prostate, as well as the exact point on which the device is positioned when taking measurements, the device is intended to include an ultrasonic imaging system, based on the use of a phased array or phase emitters, i.e. a set of emitters in which the relative phases of the signals fed to each emitter are intentionally varied in order to alter the radiation pattern of the set, involving at least 8 elements with a central frequency of at least 2 MHz, allowing the visualization of a sectorial section of the prostate, electronics associated with a wireless communications module or cable connection that allows it to be used with a computer, tablet, smartphone or other computer device that allows the visualization of the ultrasound information.

[0054] As shown in FIGS. 3 and 4, the device makes it possible to simultaneously transmit the force exerted by two indenters (5 and 6) to two sensors (10 and 11), by means of a lever mechanism (13) with central support (11) and external indenter (5), and with concentric internal cylindrical indenter (6).

[0055] In addition, as indicated above, the health care operator performing the examination must avoid contact between the bowel wall and the indenters during the insertion and removal of the device in the rectum.

[0056] For this purpose, the device can incorporate two alternative systems to facilitate the maneuver: [0057] 1. A sheath that covers the indenter and that is removed once the area to be assessed has been reached; or [0058] 2. A retraction system, internal to the stem, which retracts the indenter into the stem body during insertion and allows it to be extracted when the area to be assessed has been reached, by means of a control system in the handle.

[0059] Finally, it only remains to note that, as mentioned above, the number of pressure sensors could optionally be increased in order to simplify the use of the device by simultaneously palpation a larger surface area.