Intra-Vaginal Ring with Pressure Sensor

Abstract

The present invention relates to a device for determining intra-abdominal pressure in a subject, comprising an intravaginal ring that is provided with a pressure sensor, means for registering the intra-abdominal pressure value measured by the pressure sensor and means for generating an alert signal when the intra-abdominal pressure exceeds a reference value. The present invention also relates to a method for determining intra-abdominal pressure in a subject, comprising the steps of: a) measuring the intra-abdominal pressure in the vagina by means of a device of the invention, b) comparing the intra-abdominal pressure value measured with a reference value; and c) in case the intra-abdominal pressure value exceeds the reference value transmitting an alert signal to the device that triggers a vibration element in the device or an external device, such as a smartphone or smart watch, to provide a warning to change the subjects behaviour in order to lower the intra-abdominal pressure value.

Claims

1. Device for determining intra-abdominal pressure in a subject, comprising an intravaginal ring that is provided with a pressure sensor, means for registering the intra-abdominal pressure value measured by the pressure sensor and means for generating an alert signal when the intra-abdominal pressure exceeds a reference value.

2. Device as claimed in claim 1, further comprising means for transmitting the pressure value measured to an external device, in particular a computer outside the subjects body.

3. Device as claimed in claim 3, further comprising means for receiving instructions from the computer.

4. Device as claimed in claim 1, wherein the means for generating an alert signal comprise a vibration element integrated in the ring.

5. Device as claimed in claim 1, wherein the means for generating an alert signal comprise means for wireless transmission of an alert signal to an external device.

6. Device as claimed in claim 5, wherein the external device is a smartphone or a smart watch.

7. Device as claimed in claim 1, wherein the means for generating an alert signal are configured to receive instructions from a computer outside the subjects body.

8. Device as claimed in claim 1, wherein the means for generating an alert signal are configured to receive instructions from the pressure sensor.

9. Device as claimed in claim 1, further comprising drug delivery means.

10. Device as claimed in claim 9, wherein the drug delivery means are configured to deliver a drug in response to the generation of an alert signal when the intra-abdominal pressure exceeds a reference value.

11. Device as claimed in claim 9, wherein the drug delivery means are configured to deliver a drug on demand.

12. Device as claimed in claim 1, further comprising means for generating an electrostimulus.

13. Device as claimed in claim 1, wherein the intravaginal ring comprising: a first rigid member having a first and second end; a second rigid member having a third and fourth end; a first flexible member coupled between the first and third ends; a flexible part coupled between the second and fourth ends; optionally a reservoir holding a drug to be delivered, an opening, and a pump for pumping said drug out of said opening, wherein the first flexible member and/or flexible part are configured for allowing the device to be squeezed by bringing the second and fourth ends together thereby transforming a shape of the ring from an extended shape to a collapsed shape for allowing the device to be inserted into a vagina of a subject at or near the fornix posterior vaginae, said extended shape corresponding to a substantially oval or annular ring shape, and wherein at least one of the first flexible member and the flexible part is at least partially elastic such that the device is pre-biased to assume the extended shape when no external force is being applied thereto.

14. Method for determining intra-abdominal pressure in a subject, comprising the steps of: a) measuring the intra-abdominal pressure in the vagina by means of a device as claimed in claim 1, b) comparing the intra-abdominal pressure value measured with a reference value; and c) in case the intra-abdominal pressure value exceeds the reference value transmitting an alert signal to the device that triggers a vibration element in the device or an external device, such as a smartphone or smart watch, to provide a warning to change the subject's behavior in order to lower the intra-abdominal pressure value.

15. Method as claimed in claim 14, wherein an instruction is transmitted to the drug delivery means to start releasing a drug into the vagina.

Description

FIGURES

[0055] In the example reference is made to the following figures:

[0056] FIG. 1: photograph of an intravaginal ring having a sensor mounted thereon.

[0057] FIGS. 2 and 3: details of the sensor.

[0058] FIG. 4: Specification sheet of the Sentron Full Bridge Pressure Sensor P4.3 (E7500349.01). The P4.3 pressure sensor is an advanced miniature pie-zoresistive sensor equipped with a full Wheatstone bridge. The full Wheatstone bridge ensures superior linearity and temperature characteristics and Sentron's advanced processing technology permits the dimensions of the sensor (L×W×H 1770×970×300 m) to remain very small. The short sensor length allows a smaller bending radius and reduces stresses on the sensor during catheter bending.

[0059] FIG. 5: registration of IAP measured intravaginally with the device of the invention and through conventional intravesical measurement.

EXAMPLE

[0060] In a pilot, a conventional UDI was performed with an intravaginal device of the invention (instead of the usual rectal sensor) and an intrabladder sensor. The UDI ran for 30 minutes. Intra-abdominal pressure was provoked by asking the patient to cough a couple of times. The bladder was slowly filled with water.

[0061] The IAP was recorded with the intravaginal pressure sensor mounted on the vaginal ring.

[0062] The pressure sensor used was provided by Welling company in Leek, the Netherlands (see FIGS. 1, 2 and 3) according to the attached specifications (FIG. 4)

The recording device used was an Uromic Jive (Medkonsult).

[0063] FIG. 5 shows that the intravaginal pressure sensor (middle line, labeled “vaginal”) clearly registered the intra-abdominal pressure registration when compared with the intravesical conventional measurement (upper line, labeled “vesical”). The vaginal pressure recording showed a signal closely resembling the intravesical pressure recording.

[0064] A vaginal ring mounted with a pressure sensor clearly registers intra-abdominal pressure differences. Because the device of the invention is suitably provided with transmission means, it can send the results online to a computer. This opens the possibility for mobile UDI's with longer registrations under more physiological circumstances than in the doctors office with various catheters and bladder provocations.

[0065] It also opens the possibility to guide patients through the difficult post-operative period, if the device can signal to the patient (for example via an app) when too much intra-abdominal pressure is applied during normal daily activities endangering the healing process.