The present invention refers to an orthotopic artificial bladder prosthesis.
As is known, when a patient's bladder is affected by severe incurable disease which compromises its proper functioning, replacement of the bladder with an artificial bladder prosthesis is desirable.
Among the various solutions developed to solve the problem is replacement of the natural bladder with a compressible bladder made of soft multi-layer silicone emptying of which takes place by simply compressing the lower abdomen, as described in patent WO 2007/039159. This type of prosthesis provides a connection between the ureters and urethra and said artificial bladder through the use of sutures. However, securing with sutures is not always possible, as in the case, for example, of the ureters and/or urethra being weakened and/or thinned for congenital or pathological reasons. Furthermore, the use of sutures requires high manual skill as well as further use of time during the replacement procedure.
Object of the present invention is to overcome the drawbacks of the prior art, by providing an orthotopic artificial bladder prosthesis that is able to replace the natural bladder and which allows a considerable improvement in the patient's quality of life.
Another object of the present invention is to provide such an orthotopic artificial bladder prosthesis that does not require the use of sutures to secure the ureters and/or the urethra to said artificial bladder thus avoiding the risk of tissue necrosis.
Yet another object of the present invention is to provide such an orthotopic artificial bladder prosthesis that is easy to produce.
These objects are achieved in accordance with the invention with the characteristics listed in appended independent claim 1.
Advantageous embodiments of the invention will be apparent from the dependent claims.
The orthotopic artificial bladder prosthesis according to the invention comprises an enclosure or bag or balloon made from a multi-layer membrane of soft and elastic synthetic material, the inner layer of which is able not to deteriorate with urine whereas the outer layer is suitable to prevent fusing with the surrounding tissues. Said orthotopic prosthesis further comprises at least two holes for connecting the ureters to said prosthesis and the same number of hollow elements having a widened circular flat base and a tubular portion passing through said holes which has substantially the same inner diameter as the outer diameter of ureters such as to accomplish an interference fit without the necessity to use glues for fixing the ureters inside said tubular portion. The ureters are then inserted forcibly inside said tubular portion of the hollow element without substantially narrowing the ureters lumen.
Further characteristics of the invention will be made clearer by the detailed description that follows, referring to a purely exemplifying and therefore non limiting embodiment thereof, illustrated in the appended drawings, in which:
a and 5b are, respectively, a top view and a mid-length sectional view of a second embodiment of the hollow element;
a is a perspective exploded, cut-away view showing the assembly between the hollow element of
a is a front view of a precursor of an orthotopic artificial bladder prosthesis of a second embodiment to be coupled to the hollow element illustrated in
b is a sectional view of
c,
7
d, 7e are sectional views of the details indicated respectively with C, D and E in
a e 8b are, respectively, a top view and a mid-length sectional view of a sleeve to be coupled to the hollow element of
In
The prosthesis 1 of
The outermost layer 3 of the silicone membrane 2 can be texturized so as to obtain a rough surface or it can be coated with turbostratic pyrolytic carbon, in order to reduce the risk of adhesion of the fibrous capsule to the prosthesis 1. Preferably the outermost layer 3 is coated with turbostratic pyrolytic carbon. The inner surface of the prosthesis 1, on the other hand, is coated with a microfilm 4 of highly biocompatible material, such as pyrolytic turbostratic carbon, for example, having a thickness of about 0.2-0.3 microns.
The process for obtaining said membrane is described in patent application WO 2007/039159 fully incorporated herein by reference.
The prosthesis 1 shown in
Said portions 7 of membrane, which are of a larger size than the hole 5 (
As shown in
The tubular portion 10 has an inner diameter between 5 and 30 charrier (Ch) or between 5 and 15 Ch, a thickness between 1.0 and 10 mm and a length not exceeding about 5 cm. The circular base 11 has a diameter not exceeding that of the hole 5 on which the membrane 7 is applied.
The hole 9 on the membrane 7 generally has a size between 5 and 30 Ch unit and is such as to allow forcible passage of the tubular part 10 of the hollow element 200. It should be noted that 1 Ch corresponds to ⅓ mm.
The hollow element 200 inclusive of the tubular portion 10 is preferably coated, both on the inside and on the outside, with highly biocompatible biomaterial, such as for example pyrolytic turbostratic carbon.
During the surgical stage the ureter 6 is inserted forcibly inside the tubular portion 10 of the hollow element 200 which grips lightly around the tube of the ureter 6 thanks to its elasticity. The ureter is inserted inside the tubular portion 10 so as to protrude with respect to the circular base 11 of the hollow element 200 as illustrated in
In this manner it is no longer necessary to fix the ureter 6 to the portions of membrane 7 by means of sutures as happens, on the other hand, in the prior art illustrated in
In another embodiment (not illustrated in the figure) of the invention the membrane 7 is absent and the hole 9 which allows the passage of the hollow element 200 is formed directly on the membrane 2 of the prosthesis 1 without having to make the hole 5 illustrated in
Naturally, the hollow element 200, suitably sized, can also be used to connect the ureter 8 to the prosthesis 1.
Furthermore, the artificial prosthesis 1 on which the hollow elements 200 are used to secure the ureters 6, 6′ according to the present invention can be an artificial prosthesis which has a catheter or stent in place of the urethra 8.
As an alternative to the embodiment illustrated in
Said element 300 is a single piece and has a tubular portion 10 in which to insert the ureter similarly to what was described previously in relation to element 200, and a truncated conical portion 14 connected to said tubular portion 10 by means of a circular surface 13 (
In a preferred embodiment of said element 300, the tubular portion 10 has an inner diameter of about 6 mm and an outer diameter of about 10 mm, a total length of about 50 mm, of which 30 mm represent the length of the tubular part 10, and a diameter of the circular surface 13 of about 20 mm.
Said one-piece element 300 is preferably coated with pyrolitic turbostratic carbon both internally and externally, and is preferably used in combination with an artificial bladder also coated with said turbostratic carbon both internally and externally but not texturized.
Coupling of said single piece 300 as defined above to an artificial bladder or prosthesis 1, also coated with turbostratic carbon both internally and externally but not texturized, is achieved through a process having a sequence of stages which will be described hereunder.
To start with, a prosthesis in the form of a balloon 600 (
Said membrane 2 can be multi-layered and made with a thickness so as to be compressible, deflatable and collapsible, for example of about 600 microns consisting for example of 20 layers of silicone, each having a thickness of about 30 microns, obtained in accordance with what is described above. Alternatively, said membrane 2 can be a single layer made by means of silicone moulding.
In a preferred embodiment said balloon 600 has a thickness of 0.6 mm and a diameter between about 72 and 74 mm.
On said balloon 600 an aperture (not illustrated) and three circular holes 603′ (
After said balloon 600 has been obtained, a circular conical frustum 602 (
Said conical frustum 602 serves as a guide for insertion of the urethra during the surgical stage, as will be described hereunder. The other two flattened circular areas coinciding with the two stoppers 603, without the conical frustum 602, on the other hand, will serve for coupling with above mentioned respective elements in a single piece 300 as will be described hereunder.
After the silicone balloon 600 has been obtained, a first deposition of turbostratic carbon will be made on the outer surface 601, according to the prior art, after having shielded the edges of the aperture mentioned previously, then proceeding with a first vulcanization of said balloon 600.
Once the balloon 600 provided with the cone 602 with the outer surface 601 coated with turbostratic carbon like the lateral surface of the conical frustum 602 has been obtained, said balloon is turned inside out a first time through the aperture (not shown in the figure) so as to bring the surface 601 and the cone 602 from the outside to the inside of the balloon 600.
At this point the inner surface 604 opposite the surface 601 is turned to the outside: coating of said surface 604 is then performed by means of application of turbostratic carbon after suitable shielding of the surfaces 605 of the stoppers 603 now facing outwards, and of the edges of the opening for turning inside out.
A second vulcanization is subsequently carried out, after which the shielding of the surfaces 605 (
At this point it is possible to make a through hole 9 (or 9′) (
At the end of gluing each element 300 has its own conical portion 14 (
Said one-piece element 300 has been coated with turbostratic carbon both internally and externally, similarly to what was done on the balloon 600 with shielding of the surface 13, making a longitudinal cut, shielding the edges of said cut, applying the turbostratic carbon on both surfaces of the opened longitudinally cut piece 300, vulcanizing, and subsequently removing the shielding of the edges of the cut to be able to carry out gluing of said two shielded edges.
After coupling of one or two elements 300 with the balloon artificial bladder 600, the balloon 600 is turned inside out again returning thus to the situation illustrated in
At this point the edges of the aperture for turning the balloon inside out can be glued together in order to obtain a closed balloon 600 and thus a closed bladder.
The above mentioned gluing operations are preferably carried out with the glue 500 previously described.
The through hole 9 (or 9′) is preferably made using a stainless steel neurosurgery stylet or a punch.
With the procedure thus far described an orthotopic prosthesis 1 of artificial bladder 600 coated both internally and externally with turbostratic carbon is obtained, with the conical frustum 602 and the tubular portion 10 of the one-piece element 300 faced outwards which is ready to be implanted in the patient.
During the operation the conical frustum 602 will be passed through by a stainless steel punch or neurosurgery stylet in order to pierce the stopper 603 beneath the conical frustum 602 and allow the urethra 8 to enter the artificial bladder whilst each ureter 6, 6′ will be forced inside said tubular portion 10 similarly to what was described previously for the hollow element 200.
In order to give greater protection to the ureter 6, 6′ inserted in said tubular portion 10 of said one-piece element 300, and a greater rigidity to said tubular portion, it is preferable also to use a sleeve 700 (
With the process thus far described it is therefore possible to obtain another embodiment of the prosthesis 1 according to the invention where the artificial bladder 1 is a non texturized balloon 600 but is coated internally and externally with pyrolytic turbostratic carbon, which further comprises a conical frustum 602 able to connect said prosthesis 1 to said urethra 8. Furthermore, said balloon provides for the hollow element for fixing of the ureters 6. 6′ to be a single piece 300 coated internally and externally with pyrolytic turbostratic carbon which is formed by a frustoconical portion 14 in addition to the widened base 13 which is connected to the tubular portion 10 which will be inserted in the through holes 9. 9′, similarly to what is reported for the element 200, whereas the widened base 13 of the element 300 will come into contact with the inside surface 605 of said membrane 2, similarly to the circular base 11 of the element 200 previously described.
Numerous changes and modifications of detail within the reach of a person skilled in the art can be made to the present embodiment of the invention without thereby departing from the scope of the invention as set forth in the appended claims.
Number | Date | Country | Kind |
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MI2009A 000004 | Jan 2009 | IT | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/EP09/09280 | 12/28/2009 | WO | 00 | 7/1/2011 |