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Title:
STRUCTURE OF ARTIFICIAL URINARY BLADDER
Document Type and Number:
WIPO Patent Application WO/2012/120326
Kind Code:
A1
Abstract:
A structure of artificial urinary bladder (1 ) comprises at least one inlet (11a and lib) that is adapted to be put in communication with a respective ureter (110a and 110b), and an outlet (13) that is adapted to be put in communication with the urethra (130) of the patient. The hollow container body (10) is made of a flexible material and is arranged to turn from an urine containing configuration (50) to a squeezed discharge configuration that causes a discharge of urine (50) through the outlet (13). A valve is provided (20) at the outlet (13) and actuating means (30) of the valve (20) is provided movable between a closed position for closing outlet (13), when the container (10) is in the urine containing configuration, and an open position, when the hollow flexible container body (10) is in the squeezed discharge configuration. Furthermore, a squeezing means (60) of the hollow container body (10) can be present that is adapted to pass from a rest position, simultaneously to the valve (20) staying in the closed position, to a position of squeezing the hollow container body (10), simultaneously to the valve (20) staying in the open position.

Inventors:
PINZI, Novello (Viale Pistelli 89, Lido di Camaiore, I-55041, IT)
MAZZOCCHI, Tommaso (Via Gave 6, Pescia, I-51017, IT)
GIULIANI, Giuseppe (Via Giovanni XXIII 27, Pescia, I-51017, IT)
Application Number:
IB2011/001558
Publication Date:
September 13, 2012
Filing Date:
July 04, 2011
Export Citation:
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Assignee:
PINZI, Novello (Viale Pistelli 89, Lido di Camaiore, I-55041, IT)
MAZZOCCHI, Tommaso (Via Gave 6, Pescia, I-51017, IT)
GIULIANI, Giuseppe (Via Giovanni XXIII 27, Pescia, I-51017, IT)
International Classes:
A61F2/00; A61F2/04
Domestic Patent References:
WO2000054702A1
WO1993016659A1
WO2006117785A2
WO2007039159A1
WO2010078949A1
WO1995011637A1
WO2006025950A1
Foreign References:
EP0372311A1
FR2116838A5
US5041136A
US3953897A
US5902337A
Attorney, Agent or Firm:
CELESTINO, Marco (ABM Agenzia Brevetti & Marchi, Viale Giovanni Pisano 31, Pisa, I-56123, IT)
Download PDF:
Claims:
CLAIMS

1. Structure of artificial urinary bladder characterised in that it comprises:

- a hollow container body that defines an urine containing recess, said hollow container body comprising:

- an inlet that is adapted to be put in communication with at least one ureter of a patient;

an outlet that is adapted to be put in communication with the urethra of the patient;

wherein said hollow container body is flexible and is arranged to turn from an urine containing configuration to a squeezed discharge configuration, in which the urine can be discharged through said outlet;

and wherein , furthermore, there are provided:

- a valve at said outlet;

- a valve actuating means that is adapted to cause said valve to pass from an outlet closing position, when said hollow container body is in said urine containing configuration, to an outlet opening position, when said hollow flexible container body is in said squeezed discharge configuration.

2. A structure of artificial urinary bladder according to claim 1 , wherein said valve comprises a movable body that is adapted to engage with said outlet, and an actuating body that can be operated by the patient and is arranged to move from a closed position to an open position; wherein said actuating body is arranged to cause in turn said movable body to move from said closed position to said open position.

3. A structure of artificial urinary bladder according to claim 1 or 2, where the valve actuating means is a magnetic means.

4. A structure of artificial urinary bladder according to claim 3, wherein said valve body comprises a valve magnet and said actuating body comprises an actuating magnet.

5. A structure of artificial urinary bladder according to claim 2, wherein said valve body comprises a valve magnet and said valve body is engaged slidably or rotatably with the actuating body, and a fixed actuating magnet is provided, said actuating body arranged to move said valve body relatively with respect to said fixed actuating magnet.

6. A structure of artificial urinary bladder according to claim 5, where in said open position said valve magnet and said actuating magnet are in a repelling position.

7. A structure of artificial urinary bladder according to claim 5, where in said open position said valve magnet and said actuating magnet are in an attracting position.

8. A structure of artificial urinary bladder according to claim 5, wherein a resilient element is provided that acts on said valve body in antagonism to an attracting or repelling force between said valve magnet and said actuating magnet.

9. A structure of artificial urinary bladder according to claim 5, wherein a first body among said valve body and said actuating body can comprise two magnets of opposite polarity, such that a second body among said valve body and said actuating body can be brought to a relative repelling position or attracting position with respect to the first among said valve body and said actuating body without the need of resilient antagonist elements.

10. A structure of artificial urinary bladder according to any of claims from 1 to 9, wherein a means is provided for squeezing said hollow container body that is arranged to turn said hollow container body into said urine containing configuration, simultaneously to the movement of said valve to said closed position, or into said squeezed configuration, simultaneously to the movement of said valve to said open position.

11. A structure of artificial urinary bladder according to claim 10, wherein said squeezing means comprises:

- a squeezing body integral to said hollow container flexible body;

- a control body, movable relatively with respect to said squeezing body, in order to cause said squeezing body to pass from a first position, for turning said hollow container body into said urine containing configuration, to a second position, for turning said hollow container body into said squeezed configuration.

12. A structure of artificial urinary bladder according to claim 2 and 11 , wherein said control body and said actuating body are integral to each other, such that a patient who moves the actuating body moves also the control body.

13. A structure of artificial urinary bladder according to claim 10, wherein the squeezing means is magnetic.

14. A structure of artificial urinary bladder according to claim 13, wherein the squeezing means comprises:

- a squeezing magnet integral to said squeezing body;

- a driving magnet integral to said control body, said driving magnet movable relatively with respect to said squeezing magnet, in order to cause said squeezing magnet to pass from a first position, for turning said hollow container body into said urine containing configuration, to a second position, for turning said hollow container body into said squeezed configuration.

15. A structure of artificial urinary bladder according to claim 14, wherein the driving magnet is mounted integral to an actuation shaft, said actuation shaft arranged to rotate to a first predetermined angle for bringing the driving magnet from the first position to the second position.

16. A structure of artificial urinary bladder according to claim 15, wherein in the second position the driving magnet moves by magnetic force the squeezing magnet to cause a squeezing of the container body, such that said actuation shaft can return the driving magnet and the squeezing magnet to the first position.

17. A structure of artificial urinary bladder according to claim 14, wherein said control body and said actuating body are integral to an actuation shaft, such that by rotating said actuation shaft from a first to a second angular position, at the same time a movement is obtained of both said control body and of said actuating body.

18. A structure of artificial urinary bladder according to claim 1 and 10, wherein both the squeezing means and the valve actuating means are magnetic.

19. A structure of artificial urinary bladder according to claim 5 and 14, ^wherein the actuation shaft is arranged to rotate from said first to said second angular position, for moving at the same time said actuating magnet and said driving magnet.

20. A structure of artificial urinary bladder according to claim 14, wherein the actuation shaft is integral to a gearing, for example a pinion gear, and a rack is provided that is adapted to mesh with said gearing, said rack movable between an advanced position and a withdrawn position for causing said actuation shaft to rotate from said first to said second angular position.

21. A structure of artificial urinary bladder according to claim 14, wherein the actuation shaft can rotate, with a single operation that is actuated from the exterior of the patient, between a first angular position, in which the hollow container body is in the above described urine containing configuration and the valve blocks said outlet, and a second angular position, in which the hollow container body is in the above described squeezed discharge configuration and the valve opens the outlet.

22. A structure of artificial urinary bladder according to claim 20, comprising an actuator, for example a hydraulic actuator, said actuator arranged to move said rack between said advanced position and said withdrawn position, in particular the actuator is operated hydraulically by a pump element, for example a membrane arranged in a point accessible from the exterior, either extracutaneous or subcutaneous, of the patient's body.

23. A structure of artificial urinary bladder according to claim 1 , wherein the squeezing means can comprise a squeezing frame associated with the flexible container.

24. A structure of artificial urinary bladder according to claim 1 , wherein the squeezing frame comprises a first portion and a second portion movable relatively to each other, in order to bring the flexible container from the urine containing configuration to the squeezed discharge configuration and vice-versa.

25. A structure of artificial urinary bladder according to claim 24, wherein at least one among the first and the second portion of the squeezing frame is adapted to rotate for causing the movement of the hollow flexible container body from the urine containing configuration to the squeezed discharge configuration and vice-versa.

26. A structure of artificial urinary bladder according to claim 24, wherein the first and the second portion of the squeezing frame can be arranged to move towards/away from each other for bringing the hollow flexible container body from the urine containing configuration to the squeezed discharge configuration and vice-versa

27. A structure of artificial urinary bladder according to claim 24, wherein the squeezing frame comprises a plurality of rods engaged to said first and to said second portion, during the relative movement of the first and of the second portion said rods can be arranged to turn from a squeezing configuration, in which the container is in the squeezed discharge configuration, to a rest configuration, in which the container is in the urine containing configuration, and vice-versa.

28. A structure of artificial urinary bladder according to claim 24, wherein the squeezing frame and/or the hollow container body can be made of an electroactive polymer, i.e. a polymer that can be deformed for moving to a shrunk configuration, or to a relaxation configuration, responsive to a voltage to it applied.

29. A structure of artificial urinary bladder according to claim 1 and 10, wherein a radio frequency feeding means is provided, or RFID, that is adapted to operate said means for squeezing said container and/or said actuating means.

30. A structure of artificial urinary bladder according to claim 1 and 10, wherein the squeezing frame comprises a plurality of ring elements, for example made of a polymeric electroactive material.

31. A structure of artificial urinary bladder according to claim 1 and 10, wherein the hollow container body can be made of a shape memory material, such that when the squeezing means is in the rest position the container, which is not subject to a squeezing action, returns to an urine containing predetermined configuration.

32. A structure of artificial urinary bladder according to claim 1 , wherein at least one fastening bracket is provided that is adapted to be fastened to the container body, to a ligament tissue, or to a bone of the patient, for example to the pubic bone.

Description:
TITLE

STRUCTURE OF ARTIFICIAL URINARY BLADDER DESCRIPTION

Field of the invention

The present invention relates to the medical field and, in particular, it relates to a structure of artificial urinary bladder that can be implanted in patients who have been subject to surgical removal of the bladder for serious bladder diseases.

Background of the invention

As well known, bladder cancer has a high incidence in both men and women. The treatment for an advanced bladder cancer staging needs the removal of the bladder. The latter is a container for urine, therefore, once removed, the need arises for providing an exit path for the urine present in the bladder of the patient out of the human body.

The most common operation carried out on elder patients is ureterocutaneostomy, where the two ureters are anastomized directly to the skin or to an intestinal portion, suitably insulated, and then from the latter to the skin. The urine is, then, drained into two external plastic bags connected to the abdomen.

However, for part of the patients this solution is psychologically frustrating, since the plastic bags often can detach, or cause bad smell, and therefore they can negatively affect a normal social life. Most of the patients regard this solution not acceptable and socially invalidating.

A second solution is a reconstruction of the bladder using an intestinal segment. The operation provides removing from the ileum a portion of about 30 cm of intestine, and then treating it for transforming the original tubular shape into a substantially spherical shape with a diameter of about 7/8 cm. Then, it is implanted in the patient at the natural position of the bladder. Finally, the ureters and the urethra are anastomized to the neobladder.

However, this type of operation causes many problems. Firstly, there is a high degree of difficulty inherent in the operation, thus enabling its execution only in a few specialized centers, and it has a high morbidity, with consequent complications and sometimes mortality. Furthermore, owing to problems of incontinence in almost all cases, the patient is forced to wear incontinence pads, or adult diapers, with subsequent physical and psychological disadvantages.

Other types of neobladders exist, so-called heterotopic or orthotopic bladders, which do not provide the use of plastic bags, but have always in any case drawbacks of other kind, such as a certain difficulty of execution, infections up to renal failure, metabolic disorders. Some examples of neobladders are described in WO2007039159, WO2010078949.

Other types of artificial urinary bladders exist, as described in WO9511637 or US3953897, which however have problems of incontinence in case of patients where the urethra and the relative sphincter mechanism are removed.

Another prosthesis, as described in US5902337, provides a valve closure system. Moreover, in the case of patients that still have a healthy bladder, but problems to the urethra, closure systems exist for the urethra by means of artificial valves, for example described in WO 2006025950.

Notwithstanding the above, a permanent solution is desirable, which enables the patient to feel completely recovered from the disease, with a full social not debilitating integration, which the surgical strategies of the prior art do not allow.

Summary of the invention

It is therefore a feature of the present invention to provide a structure of artificial urinary bladder capable of eliminating the problems of postoperative chronic infections, as well as to reduce sequels, complications and alterations from a normal body scheme.

It is another feature of the present invention to provide a structure of artificial urinary bladder that is adapted to avoid an unintentional urine release from the patient. It is also a feature of the present invention to provide a structure of artificial urinary bladder that has a high capacity, in order to increase the time between two successive urine emptying actions.

It is also a feature of the present invention to provide a structure of artificial urinary bladder capable of reducing, or eliminating completely, problems of rejection from the body of the patient.

It is a further feature of the invention to provide a structure of artificial urinary bladder that is of easy to use by the patient.

These and other features are accomplished with one exemplary structure of artificial urinary bladder comprising:

- a hollow container body that defines an urine containing recess, said hollow container body comprising:

- an inlet that is adapted to be put in communication with at least one ureter of a patient;

an outlet that is adapted to be put in communication with the urethra of the patient;

wherein said hollow container body is flexible and is arranged to turn from an urine containing configuration to a squeezed discharge configuration, in which the urine can be discharged through said outlet;

and wherein , furthermore, there are provided:

- a valve at said outlet;

- a valve actuating means that is adapted to cause said valve to pass from an outlet closing position, when said hollow container body is in said urine containing configuration, to an outlet opening position, when said hollow flexible container body is in said squeezed discharge configuration.

In particular, said valve can comprise a movable body that is adapted to engage with said outlet, and an actuating body that can be operated by the patient and is arranged to move from a closed position to an open position; wherein said actuating body is arranged to cause in turn said movable body to move from said closed position to said open position. Advantageously, the valve actuating means is a magnetic means, in particular it can comprise permanent magnets.

Advantageously, said valve body can comprise a valve magnet and said actuating body can comprise an actuating magnet.

Alternatively, said valve body can comprise a valve magnet and said valve body is engaged slidably or rotatably with the actuating body, and a fixed actuating magnet is provided, said actuating body arranged to move said valve body relatively with respect to said fixed actuating magnet.

In a first exemplary embodiment in said open position said valve magnet and said actuating magnet are in a repelling position.

Alternatively, in said open position said valve magnet and said actuating magnet are in an attracting position.

In a possible exemplary embodiment, a resilient element is provided that acts on said valve body in antagonism to an attracting or repelling force between said valve magnet and said actuating magnet.

In a possible exemplary embodiment a first body among said valve body and said actuating body can comprise two magnets of opposite polarity, such that a second body among said valve body and said actuating body can be brought to a relative repelling position or attracting position with respect to the first among said valve body and said actuating body without the need of resilient antagonist elements.

In an exemplary embodiment of the invention, furthermore, a squeezing means can be provided for squeezing said hollow container body that is arranged to turn said hollow container body into said urine containing configuration, simultaneously to the movement of said valve to said closed position, or into said squeezed configuration, simultaneously to the movement of said valve to said open position.

In particular, said squeezing means can comprise:

- a squeezing body integral to said hollow container flexible body;

- a control body, movable relatively with respect to squeezing body, in order to cause said squeezing body to pass from a first position, for turning said hollow container body into said urine containing configuration, to a second position, for turning said hollow container body into said squeezed configuration.

In an advantageous exemplary embodiment, said control body and said actuating body are integral to each other. This way, a patient who moves the actuating body moves also the control body.

Advantageously, the squeezing means can be a magnetic means, in particular it can comprise permanent magnets.

In particular, the squeezing means comprises:

- a squeezing magnet integral to said squeezing body;

- a driving magnet integral to said control body, said driving magnet movable relatively with respect to said squeezing magnet, in order to cause said squeezing magnet to pass from a first position, for turning said hollow container body into said urine containing configuration, to a second position, for turning said hollow container body into said squeezed configuration.

In particular, the driving magnet is mounted integral to an actuation shaft, said actuation shaft arranged to rotate to a first predetermined angle for bringing the driving magnet from the first position to the second position. More in detail, in the second position the driving magnet moves by magnetic force the squeezing magnet to cause a squeezing of the container body. The actuation shaft can, then, rotate in an opposite direction, or to a second predetermined angle in the same direction as to the first predetermined angle, for bringing the driving magnet and the squeezing magnet to the first position.

In particular, said control body and said actuating body can be integral to an actuation shaft, such that by rotating said actuation shaft from a first to a second angular position, at the same time a movement is obtained of both said control body and of said actuating body.

In particular, both the squeezing means and the valve actuating means are magnetic. In particular, the actuation shaft is arranged to rotate from said first to said second angular position, for moving at the same time said actuating magnet and said driving magnet.

In a possible exemplary embodiment, the actuation shaft is integral to a gearing, for example a pinion gear, and a rack is provided that is adapted to mesh with said gearing, said rack movable between an advanced position and a withdrawn position for causing said actuation shaft to rotate from said first to said second angular position.

This way, the actuation shaft can rotate, with a single operation that is actuated from the exterior of the patient, between a first angular position, in which the hollow container body is in the above described urine containing configuration and the valve blocks said outlet, and a second angular position, in which the hollow container body is in the above described squeezed discharge configuration and the valve opens the outlet.

Advantageously, the rack is integral to a stem of an actuator, for example a hydraulic actuator, said actuator arranged to move said rack between said advanced position and said withdrawn position. The actuator can be operated hydraulically by a pump element, for example a membrane arranged in a point accessible from the exterior of the patient's body, extracutaneous or subcutaneous.

In a possible exemplary embodiment the squeezing means can comprise a squeezing frame associated with the flexible container.

In particular, the squeezing frame can comprise a first portion and a second portion movable relatively to each other, in order to bring the flexible container from the urine containing configuration to the squeezed discharge configuration and vice-versa.

In a possible exemplary embodiment, at least one among the first and the second portion of the squeezing frame is adapted to rotate for causing the movement of the hollow flexible container body from the urine containing configuration to the squeezed discharge configuration and vice-versa. In an exemplary embodiment, the first and the second portion of the squeezing frame can be arranged to move towards/away from each other for bringing the hollow flexible container body from the urine containing configuration to the squeezed discharge configuration and vice-versa

Advantageously, the squeezing frame can comprise a plurality of rods engaged to said first and to said second portion, during the relative movement of the first and of the second portion said rods can be arranged to turn from a squeezing configuration, in which the container is in the squeezed discharge configuration, to a rest configuration, in which the container is in the urine containing configuration, and vice-versa. For example, each rod of the plurality of rods can be hinged to the first and/or to the second portion.

The squeezing frame and/or the hollow container body can alternatively be made of resilient material.

In a possible exemplary embodiment the squeezing frame and/or the hollow container body can be made of an electroactive polymer, i.e. in a polymer that can be deformed for moving to a shrunk configuration, or to a relaxation configuration, responsive to a voltage to it applied.

In particular, the electroactive polymer can be an acrylic polymer, or a silicone polymer.

Advantageously, a means is provided for controlling the voltage applied to said electroactive polymer, said control means arranged to apply a first voltage V1 to said electroactive polymer, for turning it into said shrunk configuration, and a second voltage V2 for turning it into said relaxation configuration.

In particular, a means can be provided for feeding a radio frequency, or RFID, that is adapted to operate said means for squeezing said container and/or said actuating means.

In particular, the squeezing frame can comprise a plurality of ring elements, for example made of a polymeric electroactive material.

In a possible exemplary embodiment, the hollow container body can be made of a shape memory material. This way, when the squeezing means is in the rest position, the container, which is not subject to a squeezing action, returns to an urine containing predetermined configuration.

In particular, the squeezing frame may have reticular shape. For example, the squeezing frame with reticular shape can comprise a first and a second ring element between which a reticular structure extends that is arranged to turn from a collection configuration to the squeezed configuration.

In particular, at least one fastening bracket can be provided that is adapted to be fastened to the container body, to a ligament tissue, or to a bone of the patient, for example to the pubic bone.

Brief description of the drawings.

The invention will be now shown with the following description of an exemplary embodiment thereof, exemplifying but not limitative, with reference to the attached drawings in which:

Fig. 1 shows in an elevational view a first exemplary embodiment of a structure of artificial urinary bladder, according to the invention;

Figs. 2A and 2B show a partial cross sectional view of a detail respectively in closed and open position of a valve of opening and closing the outlet of an artificial urinary bladder;

Fig. 3 shows respectively in an urine containing configuration a partial cross sectional view of a first exemplary embodiment of the invention of the means for squeezing the flexible artificial urinary bladder, according to the invention;

Fig. 4 shows a detail of the squeezing means on the wall of the container of Fig. 3;

Fig. 5 shows the artificial urinary bladder of Fig. 3 in a squeezing configuration;

Fig. 6 shows the means for squeezing Fig. 4 in the squeezing configuration;

Figs. 7 and 8 show diagrammatically the operation of the means for squeezing the container shown in Fig. 3;

Figs. 9 and 11 show an elevational front view of an exemplary embodiment of the means for squeezing of Figs. 2 and 5, respectively in an urine containing configuration and in a squeezing configuration;

Figs. 10 and 12 show a partial cross sectional view of an exemplary embodiment of the means for actuating the valve of Figs. 3 and 6, respectively in a closed configuration and in an open configuration;

Figs. 13 and 14 show an elevational front view of another exemplary embodiment of the means for squeezing of Figs. 2 and 5, respectively in an urine containing configuration and in a squeezing configuration;

Figs. 15 and 16 show an elevational front view of a further exemplary embodiment of the means for squeezing of Figs. 2 and 5, respectively in an urine containing configuration and in a squeezing configuration;

Fig. 17 diagrammatically shows an elevational front view of still a further exemplary embodiment of the means for squeezing of Figs. 2 and 5;

Figs, from 18 to 22 show an elevational front view of partial cross section of a a further exemplary embodiment of the means for squeezing Figs. 2 and 5, and precisely of Figs. 18 and 19 in an urine containing configuration and of Figs. 20 and 21 in a squeezing configuration;

Figs. 22 and 23 show a partial cross sectional view of another exemplary embodiment of the means for actuating the valve of Figs. 3 and 6, respectively in a closed configuration and in an open configuration;

Figs. 24 and 24 show an elevational front view of the valve body and the fixed actuating body of an exemplary embodiment of the valve;

Figs. 26, 27A and 27B show the valve in an open and closed configuration, respectively in an elevational cross sectional view and in two perspective views;

Fig. 28 shows a perspective elevational side view of a further exemplary embodiment of the invention of the means for actuating the valve and of the squeezing means;

Figs, from 29 and 30 show from different angles a particular exemplary embodiment of the structure of artificial urinary bladder, according to the invention;

Fig. 31 shows a possible stiffening structure of the bladder;

Figs, from 32 to 35 show sectional views of the bladder in two configurations, containing and squeezing;

Fig. 36 shows an exemplary embodiment of the magnetic valve;

Figs. 37 and 38 shows a further exemplary embodiment of the magnetic valve.

Description of a preferred exemplary embodiment.

In Fig. 1 a first possible exemplary embodiment is diagrammatically shown of a structure of artificial urinary bladder 1 , according to the invention. It comprises a hollow container body 10 that defines an urine containing recess 15. Hollow container body 10 comprises at least one inlet 11 that is adapted to be put in communication with at least one ureter 110a of a patient. For example, hollow container body 10 can comprise a first and a second inlet 11a and 11 b that are adapted to be put in communication with a respective ureter 110a and 110b. At the inlets a check valve can be provided, not shown, for example a flexible membrane. Hollow container body 10 comprises, furthermore, an outlet 13 that is adapted to be put in communication with urethra 130 of the patient.

Preferably, hollow container body 10 is made of a flexible material and is arranged to turn from an urine containing configuration 50 (Figs. 1 and 9) to a squeezed discharge configuration that causes a discharge of urine 50 through outlet 13 (Figs. 5 and 11 ). The structure of artificial urinary bladder 1 comprises, furthermore, a valve 20 at outlet 13 and an actuating means 30 for valve 20. More in detail, actuating means 30 is adapted to operate valve 20 in a closed position for closing outlet 13, when container 10 is in the urine containing configuration (Figs. 3 and 10), or in an open position for opening outlet 13, when hollow flexible container body 10 is in the squeezed discharge configuration (Figs. 5 and 11 ).

Actuating means 30 are indicated generically as a stem 70 that moves a valve body 75. For example, within hollow container body 10 an actuation system can be provided, not shown. Obviously, other systems for moving the valve body 70 with respect to the outlet are possible. Some examples are indicated hereinafter.

The structure of artificial urinary bladder 1 can comprise, furthermore, in an exemplary embodiment of the invention, a squeezing means 60 for squeezing hollow container body 10. As shown for example in Figs. 2 and 5, squeezing means 60 is adapted to pass from a rest position, simultaneously to valve 20 staying in the closed position, to a position of squeezing hollow container body 10, simultaneously to valve 20 staying in the open position.

In a possible exemplary embodiment, squeezing means 60 can be of magnetic type. For example, as diagrammatically shown in Figs. 2 and 5, squeezing means 60 can comprise a squeezing magnet 61 integral to hollow container body 10, for example by gluing, and a valve driving magnet 65 changed over into containing recess 15 and disengaged by the wall of container 10. Valve driving magnet 65 is adapted to apply in predetermined conditions a magnetic force on the squeezing magnet 31 for causing the squeezing container 10. More precisely, the valve driving magnet 65, for example engaged to actuation shaft 70 or stem, and the squeezing magnet 61 are movable relatively, in order to move from a first position (Figs. 1 and 2), when hollow container body 10 is in the urine containing configuration, to a second position (Figs. 4 and 5), when hollow container body 10 is in the squeezing configuration, and vice-versa. In the exemplary embodiment, as shown in Figs. 2A and 2B, valve 20 comprises a valve body or stopper 75, that is adapted to be put in a closed position for closing outlet 13, or in an open position for opening outlet 13. Stopper 75 can be operated in the one, or in the other operating position through a means for manoeuvre capable of translating in the recess container 15. For example, stopper 75 can be operated by a hydraulic, or pneumatic, or mechanical, or magnetic actuator, for example operatively connected to actuation shaft 70.

In a possible exemplary embodiment of the invention, as shown in Figs. 9 and 11 , squeezing means 60 comprises a squeezing frame 160 associated with container 10, for example mounted to its exterior at a first portion 161 and at least at one second portion 162. Squeezing frame 160 has, in this embodiment, a reticular shape and comprises a predetermined number of meshes 163 that extend between portions 161 and 162. The reticular frame can be made of an electroactive polymer, or can be made of a resilient material, or of a shape memory material.

A pulling means can be provided, diagrammatically shown in the figure with a block 165, operatively connected to reticular structure 160. In particular, pulling means 165 is adapted to move the reticular frame 160 to the second position, in which container 10 is in the squeezing configuration for causing an increase of the pressure of urine 50 and then a discharge from outlet 13 which is kept in the open position by valve 20 (Fig. 11 ). At the end of the discharge step, pulling means 165 stops its action on frame 160 and the reticular structure, owing to the elasticity of the material of which it is made, returns to the first position, in which does not produce squeezing action on container 10 that can, then, return to the urine containing configuration (Fig. 9).

In a further exemplary embodiment, as shown in Figs, from 13 to 16, portions 161 and 162 provide a relative movement for bringing flexible container 10 from the urine containing configuration (Figs. 13 and 15) to the squeezed discharge configuration (Figs. 14 and 16), or vice-versa. More in detail, in the exemplary embodiment of Figs. 13 and 14, at least one among the first and the second portion 161 and 162 of frame 160 is adapted to rotate for causing the movement of flexible container 10 from the squeezed discharge configuration to the urine containing configuration. In the case shown in Figs. 13 and 14 both portions 161 and 162 are capable of rotating about an axis 163. The rotation of portions 161 and 162 in an opposite direction about axis 163 causes a torsion to the rods which causes in turn the squeezing of container 0.

In the exemplary embodiment of Figs. 15 and 16, instead, the first and the second portion 161 and 162 of squeezing frame 160 can be arranged to move towards/away from each other for bringing flexible container 10 from the urine containing configuration to the squeezed discharge configuration and vice-versa.

Squeezing frame 160 can comprise a plurality of rods 170 that are engaged, for example hinged, with first and/or second portion 161 and 162. When container 10 is in the urine containing configuration, the rods 170 are arranged in a first position, i.e. of not compression of container 10. When, instead, container 10 is in the squeezed configuration, the rods 170 are arranged in a squeezed discharge configuration of container 10, which causes an increase of the pressure of the urine in it contained. In this case, portions 161 and 162 are mounted, in order to be capable of translating relatively, i.e. of moving towards/away from each other. This way, rods 170 apply the squeezing action on container 10 when portions 161 and 162 move away from each other. Each rod 170 can comprise a plurality of segments, for example two segments 170a and 170b arranged in a kinematical chain predetermined. The segments 170a and 170b can be hinged to each other, at one end 171 , and have the other end 172 hinged respectively to the first and to the second portion 161 and 162.

In an exemplary embodiment, squeezing frame 60, or container 10, is made of an electroactive polymer, for example an acrylic polymer, or a silicone polymer. More precisely, responsive to a voltage to it applied, electroactive polymer is deformed, i.e. it is subject to relaxation, and then container 10 is in the urine containing configuration, or is shrunk, and then container 10 is in the squeezing configuration.

In this case, as diagrammatically shown in Fig. 17, a voltage control means can be provided 200 for switching the voltage applied to the electroactive polymer of frame 160, or container 10. More in detail, when container 10 has to be squeezed, control means 200 is adapted to apply a voltage V1 to electroactive polymer that causes it to shrink, such that container 10 changes from the urine containing configuration to the squeezed configuration. When, instead, container 10 has to be changed over into the containing configuration, control means 200 apply to electroactive polymer a voltage V2 different from V1 , in order to cause the relaxation of electroactive polymer.

In a further exemplary embodiment the structure of artificial urinary bladder 1 comprises a radio frequency identification means, or RFID, diagrammatically shown in Fig. 17 with block 250, that is adapted to operate squeezing means 60 directly, or indirectly through control means 200, for causing a change over of container 10 from the containing configuration to the squeezed configuration, or vice-versa the pass from the squeezing configuration to the containing configuration.

In the further exemplary embodiment, as shown in Figs, from 18 to 21 , squeezing means 60 comprises a plurality of ring elements, for example three ring elements 191 , 192 and 193. Each ring element 191 , 192 and 193 has at least one corresponding permanent magnet 181 , 182 and 183. Magnets 181 , 182 and 183 can be permanent magnets having polarity opposite to each other, and, in particular, they are arranged to face on one another with opposite N/S polarity . In particular, ring elements 191 , 192 and 193 are movable relatively to each other, in order to move from a first position, in which ring elements 191 and 193 are arranged at a distance d1 and no squeezing action is applied to container 10 (Fig. 18 and 19), to a squeezed configuration, in which ring elements 191 and 193 are arranged at a distance d2, with d2<d1 , in which container 10 is subject to a squeezing action (Figs. 20 and 21 ). For example, ring element 192, arranged between ring elements 191 and 193, can rotate about a rotation axis according to arrow 194 of Fig. 18, in order to arrange magnets 182 in a configuration of attraction of magnets 181 and 183 for causing the corresponding ring elements 191 and 193 to translate towards the ring element arranged between them. Such translation causes, therefore, an axial squeezing of container 10, according to a mechanism similar to an accordion, and then an increas of the the pressure of urine 50 contained inside.

As diagrammatically shown in Figs. 10, 12, 22 and 23, various alternative embodiments are possible for the valve of Fig. 1. In this case, valve 20 can comprise a means for choking container 10 acting at outlet 13.

In the example shown in Figs. 10 and 12, valve 20 comprises a pump means 300 of pneumatic, or hydraulic type, that is adapted to pump in, or to pump away, a fluid, for example a gas, such as air, or an inert gas such as nitrogen, in an inflation chamber 125 defined in a choke element 120, for example with ring-like shape. When in inflation chamber 125 a predetermined amount of fluid is present, choke element 120 compresses outlet 13 of container 10 avoiding the outflow of urine 50 towards urethra 130 (Fig. 10). When, instead, the fluid is pumped away from inflation chamber 125, choke element 120 does not produce the choking action on container 10 and therefore urine 50 flows out through outlet 13 into urethra 130 (Fig. 12).

Alternatively, as shown in Figs. 22 and 23, valve 20 can comprise at least two parts 21 and 22 movable towards or away from each other, like jaws. More precisely, when parts 21 and 22 are changed over into the approached configuration, they choke container 10 closing outlet 13 (Fig. 22), whereas when parts 21 and 22 are changed over into the distant open configuration, outlet 13 forms an exit passage for urine 50 towards urethra 130 (Fig. 23).

In an exemplary embodiment, as shown in Figs, from 24 to 27B, actuating means 30 are of magnetic type and are operated by a rotation. They comprise (Fig. 26) a fixed actuating body 38 and a valve body 75 for outlet 13. In particular, valve body 75 is sliding on a portion 70' of actuating shaft 70, without the ability to rotate relatively to portion 70', for example by means of a grooved coupling. Valve body 75 comprises permanent magnets 35 and 35', whereas actuating body 38 comprises permanent magnets 31 , in particular three magnets angularly spaced 120° from one another (Fig. 24). Magnets 35 and 35' have polarity opposite to each other, and, in particular, three magnets 35 are provided spaced 20° from one another and three magnets 35' spaced 120° from one another, with magnets 35 spaced 60° from magnets 35' (Fig. 25). Magnets 35' and 31 face on one another with opposite N/S polarity . Valve body 75 engaging with outlet 13 prevents from an outflow of urine, as also shown in Fig. 27A. By lifting valve body 75 with respect to the outlet up to the dashed position causes an opening of outlet 13 and an exit of urine through outlet 13 and through holes 13' made in the fixed actuating body, as also shown in Fig. 27B.

In the position shown with a continuous line in Fig. 26, corresponding to Fig. 27A, valve body 75 has magnets 35 and 31 of opposite polarity that are facing each other, and that then attract each other, keeping the valve body closed and engaged with outlet 13. By rotating actuation shaft 70 according to arrow 105, in particular 60°, the valve body tends to rotate integrally to it, bringing then magnets 35' to overlap magnets 31 , and since they have the same polarity they repel each other, pushing the valve body to slide on portion 70' up to go against abutment 95 (Fig. 27B and the position of Fig. 26 shown with dashed line).

In an exemplary embodiment, as diagrammatically shown in Fig. 28, valve driving magnet 65, in particular three magnets 65 spaced 120° from one another, and the actuating magnet of valve body 75 are mounted integral to actuation shaft 70. This way, it is possible to operate at the same time valve driving magnet 65 and the actuating magnet 35 in order to cause simultaneously the operations of squeezing container 10 by squeezing means 60 and opening valve 20 by actuating means 30. More precisely, actuation shaft 70 is adapted to rotate about a rotation axis 105, in particular 60°, for bringing valve driving magnet 65 and squeezing magnet 61 of hollow container body 10 from the first position (as shown with a dashed line in Fig. 28), in which respective surfaces 62 and 66 are not arranged facing each other and therefore they are not responsive to the magnetic force between them, to the second position (as shown with full line in Fig. 28), in which surfaces 62 and 66 are arranged facing each other and, then, they are responsive to a magnetic force of attraction, which causes squeezing magnet 61 to approach valve driving magnet 65 and therefore to squeeze hollow container body 10 with subsequent increase of the pressure of urine 50 in it contained.

As shown always in Fig. 28, in a possible exemplary embodiment, actuation shaft 70 can be integral to a gearing, for example a pinion gear 81 , and a rack 82 can be provided that is adapted to mesh with gear 81. In particular, rack 81 is movable between an advanced position (continuous line) and a withdrawn position (dashed line) for bringing actuation shaft 70 between a first angular position, in which container 10 is in the above described urine containing configuration and valve 20 blocks outlet 13, and a second angular position, in which container 10 is in the above described squeezed discharge configuration and valve 20 opens outlet 13. More precisely, rack 82 is integral to a stem 86 of an actuator 85, for example a hydraulic actuator, that is arranged to move rack 81 between the advanced position and the withdrawn position.

In the exemplary embodiment diagrammatically shown in Figs, from 29 to 35, hollow container body 10 can comprise an inner membrane 111 equipped with a predetermined number of lobes 115, each defining a corresponding containing chamber 15' within containing recess 15. At each lobe 18 inner membrane 111 is associated with a squeezing magnet 61. In the exemplifying and not limitative case of Fig. 29, inner membrane 1 has a three-lobed shape. In particular, three squeezing magnets 61a-61c are provided, for example embedded in inner membrane 111. Container 10 comprises, furthermore, an outer membrane 112 having a shape similar to that of inner membrane 111 that holds squeezing magnet 61 , so that the latter is attracted by valve driving magnet 65. Such particular shape with plural lobes of container 10 allows preserving a substantially inhaltered relative position between the axis of the inner membrane and actuation shaft 70, to which valve driving magnets 65 are connected, avoiding that the flexibility of the inner membrane brings drags the squeezing magnets to follow the valve driving magnets.

To ensure that inner membrane 111 does not rotate with respect to outer membrane 112, both the inner membrane that the outer membrane may have variable thicknesses along their perimeter (not shown in figures 34 and 35), to assist a higher flexibility in certain zones and a lower flexibility in other zones. This way, the rotation of magnets 65a-c (Fig. 34 and 35) allows squeezing the container without that membranes 111 and 112 rotate about its own axis.

As diagrammatically shown in Figs. 29-31 , the structure of artificial urinary bladder 1 can be equipped with a fastening structure 250, for fastening hollow container body 10 to a muscular tissue, or to a bone tissue of the patient, for example to the pubic bone. In particular, structure 250 has fastening brackets 251 , an upper plate 252, comprising connections for the ureters, inlets and the possible check valves, not shown. Furthermore, it has an upright 252 and a lower plate 253, to which fixed actuating body 38 is integral, in which exit holes 13' are made.

With reference to Fig. 36, it is also possible to provide a valve 20 with a movable actuating body 138, which is similar to fixed actuating body 38 of Fig. 24. By the arrangement of magnets 31 , 35 and 35' (see Figs. 24, 25), the rotation of body 138 causes a raising movement of valve body 175. This is free of raising, for disengaging outlet 13 and moving to the position indicated with a dashed line. Straps 125 are provided that contain the valve body. The rotation of movable actuating body 135, for example 60°, brings the valve body to raise, whereas a reverse rotation brings the valve body to return towards outlet 13. In an exemplary embodiment, it is also possible that only repelling magnets 31 , 35' are present, and straps 125 are resilient and work in antagonism with the repelling magnets.

In a further exemplary embodiment, as shown in Fig. 37 and 38, it is possible that only the magnets attractive work, and a spring 75 is provided that works in antagonism with the attractive magnets, for keeping valve body 275 at outlet 213.

The foregoing description of a specific embodiment will so fully reveal the invention according to the conceptual point of view, so that others, by applying current knowledge, will be able to modify and/or adapt for various applications such an embodiment without further research and without parting from the invention, and it is therefore to be understood that such adaptations and modifications will have to be considered as equivalent to the specific embodiment. The means and the materials to realise the different functions described herein could have a different nature without, for this reason, departing from the field of the invention. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation.