WO2011058386A1

WO2011058386A1 - Bladderurethral cyclical stapler

Info

Publication number: WO2011058386A1
Application number: PCT/GR2010/000051
Authority: WO
Inventors: Michail I. Nikolaidis
Original assignee: Individual
Current assignee: Individual
Priority date: 2009-11-12
Filing date: 2010-11-09
Publication date: 2011-05-19
Anticipated expiration: 2012-05-12
Also published as: GR1007048B

Abstract

Bladderurethral cyclical stapler that will be used for the anastomosis of the neck of the urinary bladder and the urethra in the open, laparoscopic and robotic radical prostatectomy, as well as for the anastomosis of the neobladder and the urethra in radical cystectomy and that is consisted of two main sections, section A and section B. Section A is consisted of: a stopcock 1.2 with a metallic bar 1.8 that ends to the metallic guide 1.1, two propulsion levers 1.3 that are connected to the carrier of the clips 1.4 and the cyclical metallic knife 1.5, external cover 1.6 and a handle cover 1.7. Section B is consisted of: a stopcock with a metallic bar 2.2, a metallic guide 2.1, metallic receptors of clips 2.3, two flexible retaining rings of the receptors of clips 2.4, external cover of the bar from a silicone membrane 2.5, an operating bearing 2.6 and a cutting surface 3.5. The main section A is inserted from the incision of the urinary bladder and the main section B, that has smaller diameter,is inserted from the external nozzle of the urethra and after they pass through the coloboma of the neck of the urinary bladder and the coloboma of the urethra respectively, they are connected to one another, the diameter of the two sections is equivalent and by a motion of the propulsion levers 1.3 they achieve to perform the anastomosis of the urinary bladder with the urethra in the open, laparoscopic and robotic radical prostatectomy as well as for the anastomosis of the neobladder and the urethra in radical cystectomy. The advantages of this invention are that with the bladderurethral cyclical stapler the following are achieved: 1. Better quality of anastomosis. 2. Less bleeding. 3. Less surgical time. 4. Great facility for the surgeon and specifically during the laparoscopic and robotic radical prostatectomy. 5. Less hospitalization time. 6. Less possibility of stenosis of the urethra at the point of anastomosis.

Description

BLADDERURETHRAL CYCLICAL STAPLER

The invention refers to the bladderurethral cyclical stapler that will be used for anastomosis of the urinary bladder and the urethra in the open, laparoscopic and robotic radical prostatectomy, as well as for the anastomosis of the neobladder and the urethra in radical cystectomy.

Cyclical anastomosis devices have been used until now for the anastomosis of the digestive system. Due to limitations of the width of the urethra, as well as of the inability to ensure the required diameter of the pipe of anastomosis it is impossible to use the current cyclical anastomosis devices for the anastomosis of the urinary bladder and urethra in the radical prostatectomy.

Until today, anastomosis of urinary bladder with the urethra is performed without the use of a certain tool, by the placement of stitches with the classic surgical techniques (using the hands).

The present invention simplifies the procedure of anastomosis and specifically presents the following advantages in relation to the previous techniques: 1. Better quality of anastomosis. 2. Less bleeding. 3. Less surgical time. 4. Great facility for the surgeon and especially during the laparoscopic and robotic radical prostatectomy. 5. Less hospitalization time. 6. Less possibility of stenosis of the urethra at the point of anastomosis.

The invention is described below and with reference to the attached designs in which: Figure 1 shows the bladderurethral cyclical stapler that is consisted of two main sections, section A and section B.

Figure 2 shows the main section A, the front part 3.1 of which is presented magnified in figure 3 for easy understanding.

Section A (figure 2) is consisted of: hollow, cylindrical external cover 1.6 (figure 3) and handle cover 1.7(figure 2) within which is arranged a co-axial metallic bar 1.8(figure 3), enabled to shift in the longitudinal direction, which bar is bearing at the distal end a metallic guide 1.1 (figure 3), in its proximal end is connected to stopcock 1.2(figure 2), which controls the displacement of bar 1.8 by rotation (by the assistance of the stopcock the metallic guide comes in and out of the front part 3.1 (figure 2) of section A.).The metallic guide 1.1 (figure 3) has an appropriate configuration in the distal end for connection to the metallic guide 2.1 (figure 7) of section B. Between the cover 1.6 and bar 1.8 are the propulsion levers 1.3(figure 3), which in the distal end are connected with the cyclical knife 1.5(figure 3) and the carrier of the clips 1.4(figure 3), and in the proximal end are bearing cover that comes out of the external cover 1.6 (figure 2). The carrier of the clips 1.4(figure 3) is ring shaped with protrusions arranged in its perimeter, which play the role of promotional pistons of the metallic titanium clips 1.9 or the absorbable clips 3.6(figures 8 and 12), through corresponding holes in the distal end of the cylindrical external cover 1.6(figures 2 and 6).

Figure 4 shows the main section B, the front part 3.2 of which is presented in magnification in figure 5, where a metallic receptor of the clips 2.3 has been removed for easy understanding. (The front part 3.2 includes the metallic guide 2.1, the receptors of the clips 2.3 and the flexible retaining rings 2.4 (figure 5) of the receptors of the clips).

Section B (figure 4) is consisted of: metallic bar 2.2, which in the proximal end has a stopcock 2.2 and the distal end, which is hollow, is bearing internal threads and is externally arranged in tiers with gradually decreasing diameter. A metallic guide 2.1 (figure 5), which has the form of a shaft and is bearing:

1) at the proximal end, external thread 3.4 (figure 9) cooperating with the internal thread of the metallic bar 2.2 (figures 5 and 9)

2) at the distal end, appropriate configuration for connection-blocking with the metallic guide 1.1 of section A

3) in between a series of protrusions 2.10 (figure 5), arranged circumferentially to align the carrier of clips 1.4 of section A with the receptors of clips 2.3 of section B 4) a disc-shaped flange 2.1 1 (figure 5), between the proximal end and the protrusions 2.10 (figure 5), which acts as a resistant-cutting surface 3.5 (figures 1 1 and 12) for the cyclical knife 1.5 of section A. Metallic receptors of the clips 2.3 (figure 5), which, when in their initial (closed) position (figure 6) completely surround the metallic guide 2.1 and are bearing in their external surface, peripheral grooves for placing flexible retaining rings 2.4 (figure 5), and in their internal surface have also tiers with gradually decreasing diameter (figures 5 and 12), cooperating with the distal end of the metallic bar 2.2 and which tiers give stability to the metallic receptors of clips 2.3, when opened. External cover of the bar, made of a silicone membrane 2.5 (figures 4 and 11) and operating bearing 2.6 (figure 2) that facilitates the surgeon to turn the stopcock 2.2 holding it with one hand. Figure 6 shows how the sections A and B coincide after the connection of their metallic guides 1.1 and 2.1 as well as the metallic receptors of clips 2.3 that are closed. Figure 7 shows how the metallic guides 1.1 and 2.1 of the two sections are connected. The metallic guide 2.1 of section B is inserted in the metallic guide 1.1 of section A and they lock. It also shows how the metallic receptors of clips 2.3 are opened when the metallic bar 2.2 of section B is advanced.

Figure 8 shows how the metallic clips made of titanium 1.9 are advanced from the carrier of the clips 1.4 as well as the propulsion of the metallic cyclical knife 1.5 after the adjoining of the propulsion levers 1.3 (figure 2).

Figure 9 where a metallic receptor of the clips 2.3 and a flexible retaining ring 2.4 have been removed in order to facilitate its comprehension, shows how the front part 3.2 is disconnected from the metallic guide 2.2 of section B by an external thread 3.4. Figure 10 shows section B that has been disconnected from the front part 3.2, as well as section A connected to the front part 3.2 of section B.

Figures 1 1 and 12 show the potential to use absorbable clips 3.6, instead of metallic titanium clips, that will lock and will secure by a clasp 3.7 that will also be made of an absorbable material and will be placed in the metallic receptor of the clips 2.3, which in this case will have at the frontal surface of their distal end recesses 3.8, receiving the clasp 3.7 (Figure 1 1). Figures 1 1 and 12 also show the cutting surface 3.5 where the cyclical metallic knife 1.5 is adjoined.

In all the designs that are shown here the numbering of sections and the partial elements remain the same.

The operation of the bladderurethral cyclical stapler during the surgical operation of radical prostatectomy is described below, with reference to the attached designs.

The urethra is exposed and a window is created underneath it on the limits of the apex of the prostate. The urethra is cut by the aid of a cutter-stitcher.

This action may be preformed by the use of a scissor or a scalpel and single stitches are placed for the stitching of the coloboma of the urethra. A cut is performed on the front wall of the urinary bladder (1.5 cm approximately) that is used for the insertion of section A (figure 1) of the bladderurethral cyclical stapler.

The technique of retaining the neck of the urinary bladder is applied, while the neck is exposed near the prostate and a window is created underneath it. This point is intersected by the aid of a cutter-stitcher (in a case of large prostate and inability to use the cutter-stitcher, an incision is made by the use of diathermy and stitching-closing of bladder's neck with single stitches). The prostate and the seminal vesicle are removed. Section B is inserted from the external nozzle of the urethra (figure 1) (that is of smaller diameter than section A, due to limitations of the width of the urethra) of the bladderurethral cyclical stapler, the front part 3.2 (figure 4) of which passes through the coloboma of the urethra by the metallic guide 2.1 (figure 5) and from the incision of the bladder the front part 3.1 (figure 2) of section A (figure 2) is inserted. We turn the stopcock 1.2 (figure 2) counterclockwise of section A (figure 2) of the bladderurethral cyclical stapler so that the metallic guide 1.1 of section A (figure 7) comes out and passes through the coloboma of the neck of the urinary bladder and locks with the metallic guide 2.1 of section B (figure 7) of the bladderurethral cyclical stapler. Then we turn the stopcock 1.2 (figure 2) of section A (figure 2) clockwise, so that the two sections (figure 6) approach. We turn the stopcock 2.2 of section B (figure 4) clockwise, in order to open the metallic receptors of the clips, 2.3 (figure 7), thus rendering the diameter of the front part 3.2 equivalent to section A.

By pressing the levers 1.3 of section A (figure 2), the carriers of the clips 1.4, (figure 3, figure 8) advance the clips 1.9 or 3.6 to the receptors of the clips 2.3 (figure 8 and 11) and at the same time the metallic cyclical knife 1.5 (figure 8) is advanced, achieving the creation of a pipe. In this way the anastomosis is accomplished. The levers 1.3 return to their initial position. We turn the stopcock 2.2 (figure 9, and 10) of section B counterclockwise and the restoration of the position and the diameter of the metallic receptors of clips 2.3 (figure 6) is achieved. By continuing to turn the stopcock 2.2 counterclockwise, section B is released from its front part 3.2 (figure 10) and is removed from the urethra. The front part 3.2 (figure 10) (also in its initial diameter), connected with section A (figure 10), is removed from the urinary bladder. The incision of the urinary bladder is stitched. Absorbable clips 3.6 (figures 1 1 and 12) may also be used instead of metallic titanium clips 1.9 that will lock and will secure with clasp 3.7, that will also be made of absorbable material and will be placed in the metallic receptor of clips 2.3.

In the designs shown here, there are used five clips, however the use of less or more clips and of different sizes is also possible.

Claims

1. Bladderurethral cyclical stapler which consists of two sections A and B and is characterized by the fact that section A consists of:

- a hollow, cylindrical external cover (1.6) and handle cover (1.7) within which is arranged a co-axial metallic bar (1.8), capable of shifting in the longitudinal direction, which bar is bearing at its distal end a metallic guide (1.1), and at its proximal end is connected to a stopcock (1.2), which controls the displacement of bar 1.8 via rotation wherein said metallic guide (1.1) has an appropriate configuration at its distal end for connection to the metallic guide 2.1 of section B,

- a cyclical knife (1.5) and a carrier of clips (1.4), at the front part (3.1) of section A, arranged around the metallic guide (1.1), and capable of moving in the longitudinal direction via a propulsion system with propulsion levers (1.3),

and by the fact that section B consists of:

- a metallic bar (2.2), with operating bearing (2.6), said bar (2.2) having at its proximal end a stopcock and bearing at its distal end, which is hollow an internal thread, said distal end being externally shaped in tiers with gradually decreasing diameter,

- a metallic guide (2.1), which has the form of a shaft and is bearing:

a) at its proximal end, an external thread (3.4) cooperating with the internal thread of the metallic bar (2.2),

b) at its distal end, an appropriate configuration for connection-locking with the metallic guide (1.1) of section A,

c) in between, a series of protrusions (2.10) ,arranged circumferentially, to align the carrier of clips (1.4) of section A with the receptors of clips (2.3) of section B, d) a disc-shaped flange (2.1 1), between its proximal end and the protrusions (2.10), which acts as a meeting-cutting surface (3.5) for the cyclical knife (1.5) of section A,

- metallic receptors of clips (2.3), which, when in their initial (closed) position completely surround the metallic guide (2.1), said receptors of clips (2.3) bearing on their external surface, peripheral grooves for placing flexible retaining rings (2.4), and having on their internal surface tiers with gradually decreasing diameter, cooperating with the distal end of the metallic bar (2.2), said tiers providing stability to the metallic receptors of clips (2.3), when in their opened position, wherein section B has smaller initial diameter than section A and after the connection, adjoining and stabilization of the metallic guides (1.1) and (2.1) of the two sections, by turning the stopcock (2.2) clockwise , the metallic bar (2.2) is advanced and the metallic receptors of clips (2.3), which are retained by the flexible retaining rings (2.4), are opened and this way the diameter of the front part(3.2) of section B is increased and is rendered equivalent to the diameter of section A,

and wherein after placement of the clips (1.9, 3.6) the stopcock (2.2) is turned counterclockwise, the diameter of the front part (3.2) of section B returns to its initial size, i.e. the metallic receptors of clips (2.3) return to their closed position, and the front part (3.2) is released from the remainder of section B and remains connected to section A.

2. Bladderurethral cyclical stapler, according to claim 1, that is characterized by the fact that by opening the metallic receptors of clips (2.3) the maximum possible diameter of the pipe of anastomosis is ensured, where the cutting edge of the cyclical metallic knife 1.5 during the propulsion process meets the cutting surface (3.5) of the metallic guide (2.1) of section B.

3. Bladderurethral cyclical stapler, according to claim 1, that is characterized by the fact that by turning the stopcock (2.2) counterclockwise: a) initially the diameter of the front part (3.2) of section B returns to its initial size, and b) thereafter, the front part (3.2) is released from the remainder of section B, remaining connected to section A in its initial diameter

4. Bladderurethral cyclical stapler, according to claim 1, that is characterized by the fact that the propulsion system consists of propulsion lever (1.3), arranged between the external cover (1.6) and the metallic bar (1.8), said propulsion levers being connected at their distal end to the cyclical knife (1.5) and the carrier of clips (1.4), and bearing at the proximal end handles coming out of the external cover (1.6).

5. Bladderurethral cyclical stapler, according to claims 1, that is characterized by the fact that the carrier of the clips (1.4) is ring-shaped and bears axial protrusions along its circumference, which function as pistons for promoting the clips (1.9, 3.6) through corresponding holes at the distal end of the cylindrical, external cover (1.6)

6. Bladderurethral cyclical stapler, according to claim 1, that is characterized by the fact that the clips (1.9) are metallic, made of titanium.

7. Bladderurethral cyclical stapler, according to claim 1, that is characterized by the fact that the clips (3.6) are made of an absorbable material.

8. Bladderurethral cyclical stapler, according to claim 7, that is characterized by the fact that the metallic receptors of clips (2.3) have, at the frontal surface of their distal end, recesses (3.8) where in clasps (3.7) for the clips of absorbable material (3.6) are placed.