Probe for measuring intravesical pressure

1 . A probe for measuring intravesical pressure within a bladder of a patient, wherein the probe measures a physiological state of the bladder and therefore eliminates a need to empty the bladder and subsequently fill the bladder with a solution prior to positioning and use of the probe, the probe comprising:

a flexible tubular element of elongated conformation and having:

a first extremity comprising a supply mouth associable with a supply means of a fluid; and

a second extremity opposite to the first extremity, positionable inside a partially or totally full bladder of a patient along a direction of insertion, the second extremity comprising a radiopaque semi-spherical shape to prevent injury to the patient during insertion of the second extremity;

wherein the probe comprises a first sensing element and a second sensing element associated with the flexible tubular element in proximity of the second extremity, wherein at least one of the first sensing element and the second sensing element is used to measure a pressure inside a bladder of the patient,

wherein the first sensing element comprises a first balloon for locking the second extremity inside the patient's bladder, the flexible tubular element having a first communication channel between the first balloon and the supply mouth,

wherein the second sensing element comprises a second balloon for measuring the pressure inside the patient's bladder, the flexible tubular element having a second communication channel between the second balloon and the supply mouth,

wherein the first extremity further comprises a first portion that is configured to be in fluid communication with the supply means and a second portion that is configured to be in fluid communication with a connecting element for an alternate connection of the second balloon to at least one of: (a) the supply means and (b) monitoring means for detecting pressure measurements,

wherein the probe comprises a third balloon that is configured to ensure a maintenance of the second balloon in a symmetrical and centered position with respect to the flexible tubular element, wherein at least one of the first balloon, the second balloon, and the third balloon has an opening at an extremity that is hydraulically sealed to a portion of the flexible tubular element, and

wherein the probe further comprises marker means for marking a position of the probe by radiography, and where the marker means comprise a non-circumferential marker in radio-opaque material that extends longitudinally along the flexible tubular element, wherein the marker means further includes tungsten filament windings that abut proximal and distal extremities of the second balloon,

wherein the first portion has a first non-return valve and the second portion has a second non-return valve,

wherein the first non-return valve and the second non-return valve are respectively used to (i) keep the first balloon inflated until a pre-established size is reached for blocking the tubular element inside the patient's bladder and (ii) responsive to a determination by the monitoring means that the first balloon is inflated to the pre-established size, inflate the second balloon with a pre-established volume of fluid dependent on at least one of (a) a size of a portion of the patient's bladder and (b) on a particular clinical requirement tied to a clinical situation of the patient, and

wherein the first portion is in fluid communication with the first communication channel for inflating the first balloon and the third balloon, and the second portion is associated with the second communication channel for inflating the second balloon with the pre-established volume of fluid, and for connecting to the monitoring means for detecting pressure measurements, the monitoring means for detecting pressure measurements comprising a transducer device for pressures measured outside the first balloon, the second balloon, and the third balloon, and with the monitoring means for detecting pressure measurements being connectable to means of displaying such pressure measurements.

2 . The probe according to claim 1 , wherein at least one of the first sensing element and the second sensing element is associated with the monitoring means for detecting pressure measurements.

3 . The probe according to claim 1 , wherein at least one of the first balloon and the second balloon comprises at least one polyolefin.

4 . The probe according to claim 1 , wherein the first balloon is arranged upstream of the second balloon with respect to the direction of insertion.

5 . The probe according to claim 1 , wherein, in correspondence of the first balloon and the second balloon, the flexible tubular element defines a first communication hole with the first communication channel and a second communication hole with the second communication channel.

6 . The probe according to claim 1 , wherein the third balloon is arranged downstream of the second balloon with respect to the direction of insertion.

7 . The probe according to claim 1 , wherein the non-circumferential marker comprises a track in radio-opaque material.

8 . The probe according to claim 7 , wherein the marker means further includes a circumferential marker in radio-opaque material adjacent to at least one extremity of the first balloon or the second balloon.

9 . The probe according to claim 1 , wherein the flexible tubular element comprises a third communication channel between the third balloon and the supply mouth to allow for inflation of the first balloon independent from the third balloon.

10 . A probe for measuring intravesical pressure within a bladder of a patient, wherein the probe measures a physiological state of the bladder and therefore eliminates a need to empty the bladder and subsequently fill the bladder with a solution prior to positioning and use of the probe, the probe comprising:

a flexible tubular element of elongated conformation and having:

a first extremity comprising a supply mouth associable with a supply means of a fluid and comprising a first portion that is configured to be in fluid communication with the supply means and a second portion that is configured to be in fluid communication with a connecting element for an alternate connection of a sensing balloon to at least one of: (a) the supply means and (b) monitoring means for detecting pressure measurements; and

a second extremity opposite to the first extremity, positionable inside a bladder in a physiological state of a patient along a direction of insertion, the second extremity comprising a radiopaque semi-spherical shape to prevent injury to the patient during insertion of the second extremity;

wherein the probe comprises a first sensing element and a second sensing element associated with the flexible tubular element in proximity of the second extremity, wherein at least one of the first sensing element and the second sensing element is used to measure a pressure inside a bladder of the patient,

wherein the first sensing element comprises a first locking balloon for locking the second extremity inside the bladder of the patient, the flexible tubular element having a first communication channel between the first locking balloon and the supply mouth,

wherein the second sensing element comprises the sensing balloon for measuring the pressure inside the patient's bladder, the flexible tubular element having a second communication channel between the sensing balloon and the supply mouth,

wherein the probe comprises a second locking balloon that is configured to ensure a maintenance of the sensing balloon in a symmetrical and centered position with respect to the tubular element, the flexible tubular element having a third communication channel between the second locking balloon and the supply mouth to allow for inflation of the first locking balloon independent from the second locking balloon, and wherein the first portion and the second portion have non-return valves used to respectively keep the first locking balloon inflated until a pre-established size is reached for blocking the flexible tubular element inside the patient's bladder and, responsive to a determination by the monitoring means that the first locking balloon is inflated to the pre-established size, to inflate the sensing balloon with a pre-established volume of fluid dependent on at least one of (i) a size of a portion of the patient's bladder and (ii) a particular clinical requirement tied to a clinical situation of the patient, and

wherein the first portion is in fluid communication with the first communication channel for inflating the first locking balloon, and the second portion is associated with the second communication channel via the connecting element for inflating the sensing balloon with the pre-established volume of fluid, and for connecting to the monitoring means for detecting pressure measurements, the connecting element being of a type of three-way tap that permits selectively connecting the sensing balloon to at least one of the supply means and the monitoring means for detecting pressure measurements, the monitoring means for detecting pressure measurements comprising a transducer device for pressures measured outside the first locking balloon, the sensing balloon, and the second locking balloon, and with the monitoring means for detecting pressure measurements being connectable to means of displaying such pressure measurements,

wherein the probe comprises a marking system for marking a position of the probe that includes (i) a non-circumferential marker in radio-opaque material that extends longitudinally along the entire flexible tubular element and (ii) a circumferential marker in radio-opaque material that is disposed adjacent to at least one extremity of the sensing balloon,

wherein the probe further comprises a marker means made in the form of tungsten windings abutting proximal and distal extremities of the sensing balloon.

11 . A probe for measuring intravesical pressure within a bladder of a patient, wherein the probe measures a physiological state of the bladder and therefore eliminates a need to empty the bladder and subsequently fill the bladder with a solution prior to positioning and use of the probe, the probe comprising:

a flexible tubular element of elongated conformation and having:

a first extremity comprising a supply mouth associable with a supply means of a fluid and comprising a first portion that is configured to be in fluid communication with the supply means and a second portion that is configured to be in fluid communication with a connecting element for an alternate connection of a second balloon to at least one of: (a) the supply means and (b) monitoring means for continuous detecting of pressure measurements,

a second extremity opposite to the first extremity, positionable inside a bladder in a physiological state of a patient along a direction of insertion, the second extremity comprising a radiopaque semi-spherical shape to prevent injury to the patient during insertion of the second extremity;

wherein the probe comprises a first sensing element and a second sensing element associated with the flexible tubular element in proximity of the second extremity, wherein at least one of the first sensing element and the second sensing element is used to measure a pressure inside a bladder of the patient,

wherein the first sensing element comprises a first balloon for locking the second extremity inside the patient's bladder, the flexible tubular element having a first communication channel between the first balloon and the supply mouth,

wherein the second sensing element comprises the second balloon for measuring the pressure inside the patient's bladder, the flexible tubular element having a second communication channel between the second balloon and the supply mouth,

wherein the probe comprises at least a third balloon configured to ensure a maintenance of the second balloon in a symmetrical and centered position with respect to the flexible tubular element, wherein at least one of the first balloon, the second balloon, and the third balloons has a plurality of openings that are hydraulically sealed to the flexible tubular element,

wherein the first portion and the second portion respectively have a first non-return valve and a second non-return valve that are respectively used to: (i) keep the first balloon inflated until a pre-established size is reached for blocking the flexible tubular element inside the patient's bladder and (ii) responsive to a determination by the monitoring means that the first balloon is inflated to the pre-established size, inflate the second balloon with a pre-established volume of fluid dependent on at least one of (A) a size of a portion of the patient's bladder and (B) a particular clinical requirement tied to a clinical situation of the patient,

wherein the first portion is communicating with the first communication channel for inflating the first balloon and the third balloon, and the second portion is associated with the second communication channel via the connecting element for inflating the second balloon with the pre-established volume of fluid and for connecting to the monitoring means for continuous detecting of pressure measurements, the connecting element being of a type of three-way tap which permits connecting, alternatively, the second balloon to supply means or to the monitoring means for continuous detecting of pressure measurements, and

wherein the first and the third balloons are configured to be inflated firstly and simultaneously, the three-way tap is configured to be positioned in such a way as to put in communication the second communication channel with the supply means associated with the connecting element, the second balloon being then configured to be inflated with the preestablished volume of fluid and the three-way tap is further configured to be positioned in such a way as to put in communication the second balloon with the monitoring means for continuous detecting of pressure measurements, the monitoring means for continuous detecting of pressure measurements comprising a transducer device for pressures measured outside the first balloon, the second balloon, and the third balloon, and with the monitoring means for continuous detecting of pressure measurements being connectable to means of displaying such pressure measurements,

wherein the probe comprises a radio-opaque marker system for marking a position of the probe, the marker system comprising a circumferential radio-opaque marker disposed adjacent to at least one extremity of the second balloon, and a non-circumferential radio-opaque marker that comprises a track in radio-opaque material that extends longitudinally along an entire length of the tubular element,

wherein probe further includes a marker means that includes tungsten filament windings that abut proximal and distal extremities of the second balloon.

12 . The probe according to claim 11 , wherein the flexible tubular element comprises a third communication channel between the third balloon and the supply mouth to allow for inflation of the first balloon independent from the third balloon.

13 . A probe for measuring intravesical pressure within a bladder of a patient, wherein the probe measures a physiological state of the bladder and therefore eliminates a need to empty the bladder and subsequently fill the bladder with a solution prior to positioning and use of the probe, the probe comprising:

a flexible tubular element of elongated conformation comprising:

a first extremity having a supply mouth associable with a supply means of a fluid; and

a second extremity opposite to the first extremity, positionable inside a bladder in a physiological state of a patient along a direction of insertion, the second extremity comprising a radiopaque semi-spherical shape to prevent injury to the patient during insertion of the second extremity;

wherein the probe comprises a first sensing element and a second sensing element associated with the flexible tubular element in proximity of the second extremity, wherein at least one of the first sensing element and the second sensing element is used to measure a pressure inside a bladder of the patient, wherein the first sensing element comprises a first balloon for locking the second extremity inside the patient's bladder, the flexible tubular element having a first communication channel between the first balloon and the supply mouth, wherein the second sensing element comprises a second balloon for measuring the pressure inside the patient's bladder, the flexible tubular element having a second communication channel between the second balloon and the supply mouth, and wherein at least one of the first balloon and the second balloon is hydraulically sealed, wherein the first extremity further comprises a first portion that is configured to be in fluid communication with the supply means and a second portion that is configured to be in fluid communication with a connecting element for an alternate connection of the second balloon to at least one of: (a) the supply means and (b) monitoring means for detecting pressure measurements; and

wherein the probe further comprises a marker system for marking a position of the probe by radiography, the marker system comprising (i) a non-circumferential marker in radio-opaque material that extends longitudinally along the length of the tubular element, (ii) a circumferential marker in radio-opaque material that is disposed adjacent to an extremity of the first balloon, and (iii) a circumferential marker in radio-opaque material comprising tungsten windings that are disposed adjacent to and abut against an extremity of the second balloon.