ES2357823B1 - SPECIAL SUPRAPUBIC INSTRUMENT APPLICATION IN PROSTHETIC ENDOSCOPIC SURGERY. - Google Patents

Abstract

Suprapubic instrument of special application in prostatic endoscopic surgery. # Complementary to the technique used by a resectoscope (4), it combines in a single tool the realization of the puncture, and the subsequent extraction of the irrigation liquid and remains of excised tissues, optimizing these processes and allowing to increase the intervention time, being able to treat larger prostate or bladder stones. Said suprapubic instrument (1) comprises puncture means (10), adapted to make a cut in the suprapubic outer area of the patient coinciding with his bladder (3), in which the lower end of the suprapubic instrument (1) is intended to be introduced. ); evacuation means (20), inside which the puncture means (10) are located, and which are adapted for the extraction of the irrigation liquid introduced by a resectoscope (4); and connecting means (30) adapted for the secure fixing of the punching means (10) and the evacuation means (20).

Description

Suprapubic instrument of special application in prostatic endoscopic surgery.

Object of the invention

The present invention belongs to the field of surgery, and more specifically to surgical instruments for extracting, treating or transporting tissues or liquids from the human body.

The main object of the present invention is a suprapubic instrument of special application in prosthetic endoscopic surgery, and it can also be used in other interventions such as cystolithotripsy.

Background of the invention

The surgical intervention of transurethral resection of the prostate (TUR), which consists in the removal of the tissue that, due to its growth, obstructs the bladder neck, making it difficult or preventing urination is widely known. In this intervention, the surgical weight is borne by the resectoscope, which is introduced through the patient's urethra, and is adapted to insert irrigation fluid into the bladder. Said operation can be performed by intermittent washing, continuous washing through the resector (Iglesias), or continuous washing through suprapubic trocar (Reuter). A third technique involves replacing the Reuter trocar with an Amplatz tube.

Intermittent washing involves removing the resector from time to time to remove water from inside the bladder, which means shortening the time available for surgery, poor endoscopic vision and increased intravesical pressure. With the use of the Reuter suprapubic trocar, what happens is that the irrigation fluid enters through the resector and exits through the trocar, so that it is controlled by direct vision (from inside the bladder, through the resector chamber ) and abroad (auxiliary personnel). This takes advantage of the entire inner gauge of the resector, so that the electric cutting handle can be larger, and the performance of the intervention is increased.

In 1992 the Venezuelan urologist Paúl Escobar replaced the Reuter trocar with a thicker, 10 mm tube. in diameter: the Amplatz instrument for percutaneous nephrolitectomy. In this intervention, the puncture and dilation of the patient's tissues is performed in several phases, first a Reuter trocar is used, then a urethral catheter is used and finally the Amplatz tube is placed inside the bladder . Then a thick tube with free outlet is connected, and the liquid column aspirating the contents of the bladder.

The disadvantages presented by the surgical tools mentioned above are the following:

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To perform suprapubic extraction of the irrigation fluid introduced by the resectoscope into the patient's bladder, several devices are needed, one to perform the puncture (cutting of the tissues until reaching the bladder), and another to introduce an exit channel for the evacuation of said liquid.

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The puncture performed by surgeons with existing surgical tools is very dangerous, since they must apply a lot of force on the patient's skin to pierce it, this being a complex operation that can damage several organs.

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The irrigation fluid evacuation channels available in current surgical tools are relatively narrow, so that the duration of the intervention is reduced to avoid endangering the patient's life, so the size of the prostates that are They can try is small.

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These surgical tools do not have an alternative outlet channel, in case you need to immediately evacuate the irrigation fluid from the bladder and the normal outlet channel is not enough.

Description of the invention

By means of the present invention, the aforementioned drawbacks are resolved by providing a suprapubic instrument intended to be used mainly, but not only, as a complement to a resectoscope during the transurethral resection surgery of the prostate, and with which said intervention is considerably optimized, combining in a single tool the puncture and evacuation of the irrigation liquid, increasing the operating time and with it the size of the prostates that can be treated.

Said resectoscope, intended to be introduced through the patient's urethra, constitutes the most important surgical tool in the transurethral resection operation, since it is she who performs the removal of the tissue that obstructs the bladder neck. This resectoscope introduces an irrigation liquid intended to be carried away with it the remains of the excised tissues, which is filling and increasing the pressure of the bladder.

It is here that the suprapubic instrument of the present invention comes into play, which is adapted to perform a puncture in the suprapubic outer area of the patient for subsequent partial insertion into the bladder. Furthermore, said suprapubic instrument is adapted for the extraction of the irrigation liquid introduced by the resectoscope and that is housed in the bladder, so that it empties and decreases the pressure in the latter.

Said suprapubic instrument, preferably with a stick-shaped configuration, comprises:

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puncture means, adapted to make a cut in the suprapubic outer area of the patient coinciding with his bladder, in which the lower end of the suprapubic instrument object of the invention is intended to be introduced,

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evacuation means, inside which the puncture means are located, and which are adapted for the extraction of the irrigation liquid introduced by the resectoscope, and

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connecting means adapted for the fixing and closing of the punching means and the evacuation means.

The punching means preferably comprise:

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an elongated con fi gurating puncture body, which presents at its lower end a scalpel adapted to make a cut in the suprapubic area of the patient coinciding with its bladder, presenting at its other end a grip element adapted for removal after making said cut, and

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a hollow cylindrical body, inside which the sharp body is housed, shorter than this, whose lower end has a beveled surface, so that the puncture is favored by gradually dilating the tissues.

Preferably said beveled surface additionally has a thread, whereby it is even easier if the puncture fits without turning the suprapubic instrument of the invention, thus avoiding having to exert great efforts on the part of the surgeon that could cause serious damage to the patient. .

Also the evacuation means, preferably of plastic material, and adapted for the extraction of the irrigation liquid introduced by the resectoscope comprise:

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an upper head, which has a curved configuration evacuation channel, whose outlet is intended to be joined with an outer plastic tube by means of which the excised tissues are removed for final deposition in a fi lter, and

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an intermediate cylindrical and elongated con fi guration tube, inside of which the puncture means are initially located, which are removed after cutting and inserting said intermediate tube into the interior of the bladder, being then adapted to evacuate the irrigation liquid Bladder content.

Said evacuation channel is wide enough to allow an exit of the irrigation liquid with the same flow rate with which it is introduced by the resectoscope, also making it possible to extend the duration of the operation for more than 1 hour (current recommended duration), so that larger prostates can be resected.

In the case where it is necessary to quickly reduce the pressure of the bladder or an obstruction occurs during the exit of the excised tissues, it is provided that the upper head additionally has an alternative outlet channel, initially plugged by a safety valve . Thus, for the opening of said alternative channel, the surgeon must simply pull out the safety valve, then allowing the excised tissues to be dislodged by a second available outlet at its upper end.

It is envisioned that the intermediate tube preferably has a pair of tabs arranged at its upper end in a facing manner, intended to be held by the hands of a surgeon, as well as a pair of vertical grooves preferably U-shaped, and may be in V or rectangular, by means of which it is possible to tear the intermediate tube from top to bottom, to be able to remove it completely once the operation is finished, and after having introduced into it a bladder catheter, which will allow the patient the continuous washing of the necessary bladder during the first 24-48 hours of the postoperative period.

On the other hand, the joining means are preferably comprised of washers and seals, which are adapted for the secure fixation of the different parts that make up the suprapubic instrument object of the invention.

Preferably, the suprapubic instrument of the present invention additionally has fixation means adapted to provide stability and attachment of the suprapubic instrument to the surgical field, so as to avoid deviations and unwanted movements that can cause errors during the intervention of the surgeon, which They can cause serious damage to the patient.

Finally, the suprapubic instrument additionally has support means, adapted for the installation and assembly of other surgical equipment or devices, arranged at the end of the upper head, by means of which the suprapubic instrument described herein can be used to perform other surgical interventions, for example the cistolitotricia (stones or stones present in the bladder).

Therefore, by means of the suprapubic instrument described in the present invention, a surgical tool complementary to the technique used by a resectoscope is provided, combining in a single tool the realization of the puncture, and subsequent extraction of the irrigation liquid and remains of excised tissues. In addition, these processes of puncture and evacuation of fluid are optimized, making it possible to increase the intervention time in order to treat prostate or larger bladder stones.

Description of the drawings

To complement the description that is being made and in order to help a better understanding of the characteristics of the invention, according to a preferred example of practical implementation thereof, a set of drawings is attached as an integral part of said description. where, for illustrative and non-limiting purposes, the following has been represented:

Figure 1.- Shows a general view of the suprapubic instrument object of the present invention.

Figure 2.- Shows a sectional view of the suprapubic instrument object of the invention where its inner ducts are appreciated.

Figure 3.- Shows a sectional view of the interior of a patient who is undergoing a transurethral resection, where the areas of application of the resectoscope and suprapubic instrument object of the invention can be seen.

Figure 4.- Shows a perspective view of the punching means, where the puncturing body and the hollow cylindrical body are appreciated.

Figure 5.- Shows a perspective view of the evacuation means.

Figure 6.- Shows a schematic view of the upper head showing the passage of the irrigation liquid through the evacuation channel, with the safety valve closed.

Figure 7.- Shows a schematic view of the upper head where the open safety valve is shown, allowing the irrigation liquid to pass through the alternative channel.

Preferred Embodiment of the Invention

In Figs. 1 and 2 a suprapubic instrument (1) is shown for use in the transurethral prostate resection surgery (2), which has a stick-shaped configuration, and comprises:

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puncture means (10), adapted to make a cut in the suprapubic outer area of the patient coinciding with his bladder (3), in which the lower end of the suprapubic instrument object of the invention is intended to be introduced, as shown by the Figure 3,

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evacuation means (20), inside which the puncture means (10) are located, and which are adapted for the extraction of the irrigation liquid introduced by a resectoscope (4), and

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connecting means (30) adapted for fixing and closing the punching means (10) and the evacuation means (20).

The punching means (10), shown in Figures 1,2 and 4, comprise:

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a puncture body (11) of elongated configuration, which has at its lower end a scalpel (12), containing at its other end a gripping element (13) adapted for removal at the time that the surgeon deems appropriate, and

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a hollow cylindrical body (14), in which the stabbing body (11) is housed, shorter than this, whose lower end has a beveled surface (15) which additionally has a thread (16) shown in Figure 4 , so that puncture is favored by gradually dilating the tissues.

Also, in Figures 1, 2 and 5, the evacuation means (20), of plastic material, and adapted for the extraction of the irrigation liquid introduced by the resectoscope (4), which include:

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an upper head (21), which has a curved configuration evacuation channel (22), the outlet of which is intended to be joined with an outer plastic tube through which the excised tissues are removed for final deposition in a fi lter, Y

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an intermediate tube (26) of cylindrical and elongated con fi guration, inside which the puncture means (10) are initially located, which are removed after cutting and inserting said intermediate tube (26) inside the bladder ( 3), being then adapted to evacuate the irrigation liquid contained therein.

As can be seen in Figure 7, in case it is necessary to quickly reduce the pressure of the bladder (3) or there is an obstruction during the exit of the excised tissues, it is foreseen that the upper head (21) additionally have an alternative outlet channel (23), initially plugged by a safety valve (24), as shown in Figure 6. Thus, for the opening of said alternative channel (23) the surgeon must simply pull out of the safety valve (24), allowing then to remove the excised tissues by a second outlet (25) also shown in the figures 6 and 7.

Likewise, in the figures 1, 2, 3 and 5 it is shown that the intermediate tube (26) has a pair of tabs (27) arranged at their upper end facing each other, intended to be held by the surgeon's hands, thus as of a pair of U-shaped vertical grooves (28), by means of which it is possible to tear the intermediate tube

(26) from top to bottom, to be able to remove it completely once the operation is finished, and after having introduced a bladder catheter, which will allow the patient to continuously wash the bladder (3) necessary during the first 24-48 hours of postoperative.

For its part, the joining means (30) are comprised of washers and seals, which are adapted for the secure fixation of the different parts that make up the suprapubic instrument (1).

Figure 2 shows that the suprapubic instrument (1) additionally has fixation means

(40) adapted for its stability and attachment to the surgical field, so that deviations and unwanted movements are avoided.

Finally, the suprapubic instrument (1) additionally has support means (50) represented in Figures 2 and 5, arranged at the end of the upper head (21) and adapted for the installation and assembly of other equipment or devices of surgery, by means of which other surgical interventions can be carried out, for example the cistolitotricia (stones or stones present in the bladder (3)).

Claims (12)

1. Suprapubic instrument (1) of special application in prosthetic endoscopic surgery characterized in that it comprises:

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puncture means (10), adapted to make a cut in the suprapubic outer area of the patient coinciding with his bladder (3), in which the lower end of the suprapubic instrument (1) is intended to be introduced,

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evacuation means (20), inside which the puncture means (10) are located, and which are adapted for the extraction of the irrigation liquid introduced by a resectoscope (4), and

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connecting means (30) adapted for fixing and closing the punching means (10) and the evacuation means (20).

2. Suprapubic instrument (1) according to claim 1, characterized in that the puncture means (10) include:

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a puncture body (11) of elongated configuration, which has at its lower end a scalpel (12), containing at its other end a gripping element (13) adapted for removal at the time that the surgeon deems appropriate, and

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a hollow cylindrical body (14), inside which the sharp body (11) is housed, shorter than this, whose lower end has a beveled surface (15).

3. Suprapubic instrument (1) according to claim 2, characterized in that the beveled surface (15) additionally has a thread (16). 4. Suprapubic instrument (1) according to claim 1, characterized in that the evacuation means (20) include:

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an upper head (21), which has a curved configuration evacuation channel (22), the outlet of which is intended to be joined with an outer plastic tube through which the excised tissues are removed for final deposition in a fi lter, Y

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an intermediate tube (26) of cylindrical and elongated con fi guration, inside which the puncture means (10) are initially located, which are removed after cutting and inserting said intermediate tube (26) inside the bladder ( 3), being then adapted to evacuate the irrigation liquid contained therein.

5.

Suprapubic instrument (1) according to claim 4, characterized in that the upper head (21) additionally has an alternative channel (23) for exiting the irrigation liquid and excised tissues.

6.

Suprapubic instrument (1) according to claim 5, characterized in that the alternative channel (23) is plugged by a safety valve (24).

7.

Suprapubic instrument (1) according to claim 6, characterized in that the alternative channel (23) has a second outlet (25) for the extraction of the irrigation liquid and excised tissues once the safety valve (24) is opened.

8.

Suprapubic instrument (1) according to claim 4, characterized in that the intermediate tube (26) has a pair of tabs (27) arranged at its upper end facing each other, as well as a pair of vertical grooves (28), by which is possible to tear the intermediate tube (26) from top to bottom, to be able to remove it completely once the operation is finished, and after having introduced a bladder catheter into it.

9.

Suprapubic instrument (1) according to claim 1, characterized in that the joining means (30) comprise washers and seals.

10.

Suprapubic instrument (1) according to claim 1, characterized in that it additionally comprises fixing means (40) adapted for its stability and attachment to the surgical field, so as to avoid deviations and unwanted movements.

eleven.

Suprapubic instrument (1) according to claim 1, characterized in that it additionally has support means (50) arranged at the end of the upper head (21) and adapted for the installation and assembly of other surgical equipment or devices, by which can be performed other surgical interventions.

SPANISH OFFICE OF THE PATENTS AND BRAND Application no .: 200930861 SPAIN Date of submission of the application: 16.10.2009 Priority Date: REPORT ON THE STATE OF THE TECHNIQUE 51 Int. Cl.: A61B17 / 34 (2006.01) A61M25 / 06 (2006.01) RELEVANT DOCUMENTS

Category

Documents cited Claims Affected

X

US 3860006 A (THE KENDALL CO.) 14.01.1975, column 3, line 33 - column 6, line 7; figures. 1,4,9-11

TO

2-3.5-8

X

US 3713447 A (ADAIR) 30.01.1973, columns 1-2; figures. 1.9

TO

2,4,8,10

X

US 4419094 A (THE KENDALL CO.) 06.12.1983, column 3, line 4 - column 6, line 39; figures. 1,4,9-11

TO

2-3.5-8

TO

US 3692029 A (ADAIR) 19.09.1972, columns 1-4; figures. 1-2,4,8-10

TO

EP 0280528 A2 (BARD LTD) 31.08.1988, column 1, line 1 - column 3, line 15; figures. 1.8

TO

GB 2216009 A (WINTER & IBE OLYMPUS) 04.10.1989, pages 1-9; figures. 1,4,10-11

TO

CH 641964 A5 (MULTORGAN STIFTUNG FUER GEIST) 30.03.1984, summary; figures 1.3. one

Category of the documents cited X: of particular relevance Y: of particular relevance combined with other / s of the same category A: reflects the state of the art O: refers to unwritten disclosure P: published between the priority date and the date of priority submission of the application E: previous document, but published after the date of submission of the application

This report has been prepared • for all claims • for claims no:

Date of realization of the report 14.04.2011

Examiner J. Square Prados Page 1/6

REPORT OF THE STATE OF THE TECHNIQUE Minimum documentation sought (classification system followed by classification symbols) A61B, A61M Electronic databases consulted during the search (name of the database and, if possible, terms of search used) INVENES, EPODOC, WPI, PAJ, ECLA.  WRITTEN OPINION Date of the Written Opinion: 04.04.2011 Statement

Novelty (Art. 6.1 LP 11/1986)

Claims Claims 2-9 1, 10-11 IF NOT

Inventive activity (Art. 8.1 LP11 / 1986)

Claims Claims 2-3, 5-8 1, 4, 9-11 IF NOT

The application is considered to comply with the industrial application requirement. This requirement was evaluated during the formal and technical examination phase of the application (Article 31.2 Law 11/1986).  Opinion Base. This opinion has been made on the basis of the patent application as published.  WRITTEN OPINION 1. Documents considered.- The documents belonging to the state of the art taken into consideration for the realization of this opinion are listed below.

Document

Publication or Identification Number publication date

D01

US 3860006 A (THE KENDALL CO.) 14.01.1975

D02

US 3713447 A (ADAIR) 30.01.1973

D03

US 4419094 A (THE KENDALL CO.) 06.12.1983

D04

US 3692029 A (ADAIR) 19.09.1972

D05

EP 0280528 A2 (BARD LTD) 31.08.1988

D06

GB 2216009 A (WINTER & IBE OLYMPUS) 04.10.1989

D07

CH 641964 A5 (MULTORGAN STIFTUNG FUER GEIST) 30.03.1984

2. Statement motivated according to articles 29.6 and 29.7 of the Regulations for the execution of Law 11/1986, of March 20, on Patents on novelty and inventive activity; quotes and explanations in support of this statement The invention defined in the main claim, as it is written in a somewhat generic manner, is considered to be novel because it is comprised in the prior art, since any of documents D01 or D02 identically discloses the object of the invention set forth in that claim. Choosing document D01 as the basis for the analysis, considered as the state of the art closest to the object of the request, in it (see column 3, line 33 - column 6, line 7 and figures, the references in brackets apply to that document) a:

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Suprapubic instrument (10) comprising:

or puncture means (13, 15), adapted to make a cut in the suprapubic outer area of the patient coinciding with his bladder (column 1, lines 8-12, column 3, lines 44-51), in which it is intended to introduce the lower end of the suprapubic instrument (10),

or evacuation means (11), inside of which the punching means (13, 15) are located, and which are adapted for the extraction of the liquid, and

or joining means (18, 19) adapted for fixing and closing the punching means (13, 15) and the evacuation means (11, 12).

Although this document D01 does not expressly indicate its possible “special application in prostatic endoscopic surgery”, but is a suprapubic catheter for draining the bladder after surgery in the area, it is clear that the instrument presented in D01 would be suitable to be used for that purpose. As specified in the "Patent Application Examination Guidelines" (SPTO - Version 1 October 2006, see Section 3.2.1.1. Interpretation of Claims: Claims referring to an entity):

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"If a claim begins with words such as" Apparatus for carrying out the procedure, etc ... "it must be interpreted as an apparatus" suitable for carrying out the procedure. "An apparatus having all the characteristics specified in the claims but that is manifestly inappropriate for the stated purpose, or that requires a modification to enable it to be used in this way, should not be considered as anticipating the claim under consideration. "

In the opposite direction, therefore, if the apparatus or instrument does not require a modification to enable its intended use, it should be considered as anticipating the claim under study. It is clear that in the main claim of the application, the intended purpose or particular use ("of special application in prostatic endoscopic surgery") does not lead to a structural difference between the claimed invention and the state of the art constituted by D01, therefore that the instrument described in this document, although this particular use is not expressly cited, would be capable of being used for the particular case of prostatic endoscopic surgery without adding any distinguishing feature. That is, there is no added feature between the object of the main claim and the instrument presented in D01.  WRITTEN OPINION Although it is cited in the claim that "the evacuation means (...) are adapted for the extraction of irrigation liquid introduced by a resectoscope" does not include any characteristic that makes them special for that extraction, whereby the evacuation means of D01 planned to drain the bladder (urine extraction) could in that intended use extract the irrigation fluid introduced by a resectoscope. If, as seems to be clear from the description of the application (page 6, lines 11-15), a certain “width” in the evacuation channel would be necessary, the instrument presented in D01 gives indications of its adequacy because as it is stated in lines 46 to 50 of column 4, the lumen of the catheter tube is large, which makes it advantageous because it decreases the possibility of blockages therein. For all the above, document D01 can be considered to assess the novelty of the application, and since it contains all the technical characteristics of the main claim, it is considered that it is not new. On the other hand, document D02 can also be considered when judging the novelty of the main claim of the application, since it also describes (see columns 1-2 and figures) a:

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Suprapubic instrument (10) of special application in prostatic endoscopic surgery (column 1, lines 4-8) comprising:

or punching means (stylet 46), adapted to make a cut in the suprapubic outer area of the patient coinciding with his bladder (column 3, lines 1-2), in which the lower end of the suprapubic instrument is intended to be introduced ( 10),

or evacuation means (14, 18, 20), inside of which the puncture means (46) are located, and which are adapted for the extraction of the liquid, and

or joining means (column 2, lines 25-46) adapted for fixing and closing the punching means (46) and the evacuation means (14, 18, 20).

This document expressly cites its use in surgery through the urethral canal in which a tube is inserted into the bladder through an abdominal incision, a tube through which liquid or gas can flow as the surgical process is performed (lines 4-8 , column 1). Therefore, the instrument of D02 has an equal use to that intended for the instrument of the application. Thus, document D02 also serves to question the novelty of the first claim. Claims 2-11 are dependent on the main claim and theoretically delimit additional optional and non-essential features. The characteristics of the second and third claims can be considered to have novelty and inventive activity, since although in D01 the characteristics of the first section of the characterizing part of the second claim are included, a hollow cylindrical body is not anticipated in D01, in whose interior houses the sharp body, of shorter length than this one, whose lower end has a beveled surface ”, nor that“ the beveled surface additionally has a thread ”. The characteristics of the fourth claim are considered devoid of inventive activity from document D01, since it is anticipated that:

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the evacuation means (11) comprise:

or an upper head (12, 24), which has an evacuation channel (23), whose outlet is intended to join with an outer plastic tube through which the excised tissues are removed for final deposition in a filter ( figure 1, explanations regarding the use given above), and

or an intermediate tube (11) of cylindrical and elongated configuration, inside which the puncture means (13) are initially located, which are removed once the cut is made and said intermediate tube (11) inserted inside the bladder (bladder), being then adapted to evacuate the liquid contained in it.

Thus, the only difference between the technical object of the fourth claim of the application under study and the content of document D01, would be that:  WRITTEN OPINION

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the evacuation channel of D01 does not have a curved configuration.

This difference is considered a lack of inventive activity for an expert in the field, as it seems a mere choice between different design possibilities for the upper head, and also the possible technical effect that is obtained with that particular design or the technical problem that is intended to be solved with it. In addition, in the embodiment of Figure 8 of document D01, the evacuation channel (43a) is presented perpendicular to the intermediate tube, giving rise to a configuration similar to the curved configuration channel of the application. Thus, in the opinion of this Administration there is a lack of inventive activity in the technical object of the fourth claim. The characteristic of the fifth claim can be considered as having novelty and inventive activity, since although in view of the embodiment of Figure 8 of document D01 (column 5, lines 24-53) it is appreciated that "the upper head ( 41) additionally it has an alternative channel (to which syringe 47 is connected) ”, at no time does it imply that this alternative channel is destined for the exit of liquids, but it has the mission of allowing a syringe to be coupled to introduce medications to the bladder, meanwhile blocking the flow of liquid through the first evacuation channel. This alternative channel has a justified technical effect in the application (page 6, line 17-23), so it does not seem obvious to a person skilled in the art to arrive at this solution as shown in D01. The sixth and seventh claims are considered with novelty and inventive activity depending on the fifth and sixth respectively. The eighth claim is considered with novelty and inventive activity because although in document D01 it is anticipated that "the intermediate tube (11) has a pair of tongues (28) arranged at its upper end in a facing manner", it is not appreciated instead to present "a pair of vertical grooves, through which it is possible to tear the intermediate tube from top to bottom, to be able to remove it completely once the operation is finished, and after having introduced a bladder catheter into it." Although an equivalent solution is presented in D05 (column 1, lines 29-40), it does not seem obvious to one skilled in the art to combine its characteristics to arrive at the solution of this claim. The characteristic of the ninth claim is considered a minor non-inventive detail, a design option available to any person skilled in the art and widely used in the state of the art. In the document D02 itself between the "joining means" a sealing gasket (o-ring 36) is presented, and in the document D01 the joining means also establish a sealing connection (see figure 3). The tenth claim (dependent on the main one) is not new because the instrument of D01 also anticipates "fixing means (20) adapted for its stability and attachment to the surgical field, so that deviations and unwanted movements are avoided" (see column 4, lines 25-28, 43-45). Finally, the generic characteristic of the eleventh claim (dependent on the principal) can also be considered anticipated by D01 and therefore lacks novelty, since in the embodiment of Figure 8 it is possible to interpret that the connection of the Syringe is made in a "support means arranged at the end of the upper head (41) and adapted for the installation and assembly of other surgical equipment or devices (47), by means of which other interventions can be performed (irrigation of solutions or medications). ”