EP2822478A1

EP2822478A1 - Device for preparing a hole formed in a bodily wall and system for making an anastomosis between a bodily wall and conduit

Info

Publication number: EP2822478A1
Application number: EP13715298.9A
Authority: EP
Inventors: Arnold Ferlin; Claude CAROZZO
Original assignee: Vetagro-Sup Institut d'Enseignement Superieur et de Recherche
Current assignee: Vetagro-Sup Institut d'Enseignement Superieur et de Recherche
Priority date: 2012-03-09
Filing date: 2013-03-11
Publication date: 2015-01-14
Also published as: WO2013132199A1; FR2987736B1; US20150080920A1; FR2987736A1

Abstract

The present invention relates to a system (SP) for preparing a hole (O) formed on a bodily wall (P), comprising: - a support body (1) defining a longitudinal axis (X) and having a proximal portion (1 a) and a distal portion (1 b) suitable for being inserted through the hole (O); - outer clamping elements (22) that can be deployed in a corolla relative to the support body (1) and are capable of covering portions of an annular surface (S) of said wall (P), and; - stressing means formed to tighten and juxtapose said outer clamping elements (22) on said body (1 ) in order to gradually deform said annular surface (S) to shape, on said wall (P), a tubular portion (T) extending along the longitudinal axis (X) and to form an anchoring clamp formed from said outer clamping elements (22).

Description

DEVICE FOR PREPARING AN ORIFICE DONE INTO AN ORGANIC WALL AND A SYSTEM FOR PERFORMING ANASTOMOSIS BETWEEN A

The present invention relates to the field of surgery, and in particular to the fields of urological, visceral and vascular surgery, etc.

More particularly, the invention relates to a surgical treatment system for performing an anastomosis between an organic wall having an orifice and a hollow organic conduit, such as the bladder and the urethra of a patient. The invention may for example be implemented following a prostatectomy, typically a total vesiculoprostatectomy, or radical prostatectomy, undergone by the patient, with the objective of surgically restoring the communication between the bladder and the terminal orifice of the urethra. , opposite the urethral meatus.

Conventionally, the anastomosis between the bladder and the urethra of a patient is performed manually by the surgeons by means of one or more suture son set up with the aid of a needle. During such an operation, the surgeons must first rebuild the neck of the bladder; for this purpose, they deform the wall of the bladder at the orifice made therein following a prostatectomy, so as to form a neck or a tubular portion intended to be connected to the urethra by means of the suture threads.

Such a method of treatment has certain advantages, particularly because it allows to carry out an abutment of the urethra and the neck or the tubular portion formed on the wall of the bladder. More specifically, such a method makes it possible to directly make the bank of the neck of the bladder and the bank of the terminal orifice of the urethra directly directly together, that is to say without having to fold one or the other of these banks on themselves.

There is thus a direct contact between the respective mucous membranes of the banks, which is particularly advantageous in terms of healing and complete and reliable recovery of the communication between the bladder and the urethra of the patient.

Nevertheless, this manual technique of anastomosis has many disadvantages and is particularly difficult to implement. Indeed, such a technique requires a particularly important intervention time and requires great dexterity on the part of the surgeon, in particular to reconstruct the neck of the bladder and precisely abut the ends of the two conduits to be connected, in this case the terminal orifice of the urethra and the neck or the tubular portion formed on the wall of the bladder. Such a manual reconnection operation proves even more delicate that the area of intervention, located at the back of the pubis, is particularly difficult to access and includes the sphincter of the patient whose integrity must be preserved throughout the intervention, avoiding its traction, its perforation , his crush, etc.

Moreover, this method of manual intervention may have the disadvantage of being performed "open", and require to make large incisions on the body wall of the patient to access the area of intervention, involving for the many inconveniences, particularly in terms of length of hospital stay, recovery time and post-operative sequelae.

Finally, the manual nature of this intervention technique makes it relatively tedious for surgeons to pay particular attention to the level of tightening of the anastomosis by suture son, and the uniformity of this level of tightening on the circumference of the anastomosis area. Indeed, insufficient tightening of the two portions of organic tubes handicaps the healing of tissues, carries a risk of infection and may ultimately cause the rupture of the connection between the two portions to be joined. Conversely, excessive tightening may cause tissue damage and may lead to stenosis in the area of anastomosis.

Another known technique is described in document US20081 14385A and consists in folding inward or outward the bank of the neck of the bladder and the bank of the terminal orifice of the urethra and joining the thus folded portions by means of a series of staples placed inside or outside the hollow organs to be treated. Nevertheless, such a technique does not give complete satisfaction especially since, the banks of the orifices of the two bodies to be connected having been folded, the junction between these two organs is not an abutment and their respective mucosa are not found in contact, which does not allow a natural consolidation of the anastomosis and requires the maintenance of permanent fixation organs, thereby increasing the recovery time of the patient, in particular its urinary functions, and likely to lead to the formation of urinary stones. In addition, the fact of folding portions of the organs to achieve their junction causes, in particular, a risk of thrombosis or stenosis at the level of the anastomosis zone when these portions are folded towards the inside of the organs to be treated, and a risk of infection when these portions are folded outward organs to be treated, their mucous membranes can then be exposed to an environment loaded with bacteria. Moreover, it will be readily understood that such a technique requires provide a large number of staples covering a large part of the periphery of the anastomosis zone, and made of non-resorbable material to ensure the durability of the anastomosis while the tissues heal.

Finally, in the context of an anastomosis between an organic wall having an orifice and a hollow organic conduit, such as the bladder and the urethra of a patient, particularly following a prostatectomy, a first difficulty consists in forming on the wall a tubular portion at the orifice, and to give this tubular portion a calibrated geometry to be able to precisely abut the end of the organic conduit and bring into contact their respective mucosa. Indeed, the orifice formed in the wall during a prior surgical procedure does not necessarily have a regular geometry, and the wall may have a variable thickness on the circumference of the orifice; thus the abutment of the hollow conduit on the wall and the contacting of their respective mucosa may be particularly difficult. None of the aforementioned techniques offers a satisfactory solution to solve this problem.

According to a first object, the present invention proposes a system for preparing an orifice arranged on an organic wall, in particular with a view to an anastomosis with a hollow organic conduit, making it possible to form in a reliable and reproducible manner on the wall, at the level of the orifice, a tubular portion having a predetermined geometry.

Furthermore, the invention aims to provide a mechanized system that offers surgeons the possibility of minimally invasive procedures, in particular via the patient's natural pathways, in order to limit the surgical trauma suffered by the patient, and to prepare reliably and reproducibly an orifice formed in a wall of an organ or a vessel, especially for subsequent anastomosis with a hollow organic conduit or a prosthesis such as a vascular prosthesis.

For this purpose, according to a first aspect, the invention relates to a system for preparing an orifice arranged on an organic wall, characterized in that it comprises:

a support body defining a longitudinal axis and having a proximal portion and a distal portion, said distal portion being adapted to be introduced through the orifice;

- External clamping elements deployable corolla with respect to the support body being distributed in the circumferential direction, and capable of covering, around said orifice, portions of an annular surface of said wall organic, and;

- biasing means arranged to constrict and juxtapose said outer clamping elements on said support body to progressively deform said annular surface to, firstly, shape on said organic wall a tubular portion extending along the longitudinal axis and, on the other hand, forming an anchor flange consisting of said outer clamping members.

Thanks to these arrangements, the wall of the member can be reliably, accurately and reproducibly prepared so as to form thereon a tubular portion extending from its orifice, said portion having a calibrated geometry, in particular with a view to end-to-end reconnection or butting to a hollow conduit. For this purpose, the external clamping elements placed outside the tubular portion of the wall in the radial direction advantageously form an anchor flange that can be used to reconnect the hollow conduit.

The invention finds a particularly advantageous application in the field of urology, and in particular for reconstructing the wall of the bladder of a patient and forming on this wall a tubular portion of predetermined geometry at an orifice formed in that for example following a prostatectomy, for anastomosis with the patient's urethra.

However, one could imagine that the tubular portion formed by means of the system according to the invention is used to connect to the wall of the organ a non-organic hollow conduit, belonging for example to a prosthesis, in particular a vascular prosthesis.

According to the invention, the support body having at least one cylindrical or substantially cylindrical portion, the biasing means are used to move the outer clamping elements to the support body, said outer clamping elements driving the wall towards the body of support bearing on portions of an annular surface extending around the orifice of the wall. The wall is then progressively deformed around its orifice so as to be pressed against the cylindrical portion of the support body and adopt a substantially tubular shape being clamped between said support body and the external clamping elements.

The external clamping elements may advantageously have at least one fastening and / or fastening tooth adapted to achieve the attachment and / or fixing of said external clamping elements on the portions of the annular surface of the wall extending around of the orifice. Advantageously, the system comprises an applicator for positioning the support body through the orifice formed in the wall and for fixing said support body on said wall. This applicator is adapted to be removably connected to the proximal portion of the support body and to control at least part of the biasing means, especially from outside the body of the patient.

According to an advantageous arrangement of the present invention, the biasing means comprise connecting elements, each connecting element being adapted to connect an external clamping element to the support body, and a traction device of the connecting elements, said elements of linkage each having a first end connected to said traction device and a second end adapted to be retained on an associated external clamping member, and said pulling device being operable to constrict and juxtapose said outer clamping members to said support body. The connecting elements are used to connect the outer clamping elements and the support body through the wall. These connecting elements are preferably flexible. They can advantageously be in the form of son, made for example of a bio-resorbable material.

The traction device may advantageously be housed inside the support body and controlled from the applicator for placing and fixing the support body. Alternatively, the traction device can be carried and controlled by the applicator.

Advantageously, it can be provided that the traction device is provided with a force limitation system for limiting the clamping of the wall on the support body by the external clamping elements. Thus, the risk of injury to the organic tissues is minimized due to excessive tightening of the connecting elements.

Preferably, there can be provided a non-return device between the connecting elements and the support body, said device being adapted to prevent loosening of the external clamping elements on the support body when the actuation of the traction device stops.

According to another advantageous arrangement of the present invention, the system further comprises a traversing and anchoring device adapted to move the second end of each connecting element between a retracted configuration in which said second end is at a radial distance from the longitudinal axis less than the radius of the orifice and an anchored configuration in which said second end is retained on an external clamping element associated after crossing the wall. Thus, the second ends of the connection elements in retracted configuration can be inserted through the orifice, then moved to the anchored configuration so as to pass through the wall and come to anchor in the external clamping elements placed on the other side of the wall.

Preferably, the traversing and anchoring device comprises support elements adapted to releasably support the second ends of the connecting elements.

Advantageously, the second ends of the connecting elements are provided with an anchoring element adapted to cooperate with a corresponding anchoring portion provided on the outer clamping elements for retaining said second ends on said external clamping elements when they reach each other. find in anchored configuration, after crossing the wall.

The support elements of the traversing and anchoring device and / or the anchoring elements equipping the second ends of the connecting elements may advantageously have a tip adapted to perforate the wall when said second ends pass from their retracted configuration to their configuration. anchored.

Preferably, in the retracted configuration, the second end of each connecting element is at a radial distance from the lower longitudinal axis or substantially equal to the outer radius of the support body.

Advantageously, the traversing and anchoring device is integrated in the support body, and extends in the distal portion of said body intended to be introduced through the orifice of the wall.

Thus, in the retracted configuration, the connecting elements and the traversing and anchoring device can be housed inside the support body, which in particular minimizes the risk of attaching and damaging tissues or altering the operation of the system according to the invention itself when it is inserted into the body of the patient.

This traversing and anchoring device may, according to a preferred embodiment of the invention, be controlled by the applicator, for example by means of a cable or a transmission rod.

According to a particular embodiment of the present invention, the system further comprises a deployment mechanism adapted to move said external clamping elements at least between a retracted configuration in which they are folded towards the longitudinal axis, and a configuration deployed in which they are spaced apart from the longitudinal axis and extend corolla substantially perpendicularly thereto, and the deployment mechanism comprises support members on which the outer clamping members are releasably supported.

The deployment mechanism is adapted to move the outer clamping elements between the retracted configuration and the deployed configuration either simultaneously or sequentially. In the case of a sequential deployment of the outer clamping elements by the deployment mechanism, the outer clamping elements can be moved individually one after the other, in a determined order, for example one after the other in the circumferential direction , or in a more dispersed way. It will also be possible to envisage sequential deployment possibly by subsets of external clamping elements, the external clamping elements belonging to each subassembly being regularly distributed in the circumferential direction. Thus, in the case of a number of six external clamping elements, it will be possible, for example, to provide two successive deployment sequences, namely a first deployment sequence during which three clamping elements spaced apart at 120 ° in the circumferential direction. are deployed, followed by a second deployment sequence in which three clamping elements spaced apart at 120 ° in the circumferential direction and interposed between the outer clamping elements deployed during the first sequence, are deployed. Still in the case of a number of six external clamping elements, it will be possible for example to provide three successive deployment sequences in pairs of diametrically opposed external clamping elements.

Thus, it can advantageously be provided that, when the second ends of the connecting elements and the external clamping elements are in a retracted configuration, it is possible to introduce from the outside of the body of the patient, in particular by means of the applicator, the assembly formed of the support body, the deployment mechanism equipped with said outer clamping elements, and biasing means at least partially housed inside the support body, through a through hole formed in a trocar placed on a external body wall of the patient, for example on the abdominal wall.

Advantageously, the deployment mechanism is provided on the end of a distal portion of the applicator adapted to be connected to the support body, said mechanism being preferably controlled by means of said applicator. According to a particularly advantageous arrangement, the applicator, and in particular the deployment mechanism arranged on the distal end of said applicator, comprises a stop element adapted to cooperate with the wall to limit the insertion of the support body through the orifice. Alternatively, the stop member could be provided directly on the support body.

In a first embodiment, the traversing and anchoring device is adapted to move the second end of each connecting element between the retracted configuration and the anchored configuration when the external clamping elements are in the deployed configuration.

In a second embodiment, the deployment mechanism is further adapted to move the outer clamping elements between the deployed configuration and a folded configuration in which said outer clamping elements are folded towards the longitudinal axis of the outer side. distal end of the support body, and said deployment mechanism belongs to the biasing means.

In this embodiment, the outer clamping members in the expanded configuration can be moved to a folded configuration by progressively driving and deforming the wall so as to press against the support body and adopt a substantially tubular shape. by being clamped between said support body and the outer clamping elements.

In the same manner as for moving between the retracted configuration and the deployed configuration of the outer clamping elements, the deployment mechanism is adapted to move the outer clamping elements between the deployed configuration and the folded configuration either simultaneously or sequentially. .

In this second embodiment, the traversing and anchoring device is adapted to move the second end of each connecting element between the retracted configuration and the anchored configuration when the external clamping elements are in folded configuration.

According to a particularly advantageous arrangement of the present invention, the support body releasably supports internal clamping elements aligned angularly in the circumferential direction with the external clamping elements, and the biasing means are arranged to tighten and juxtapose said elements of external clamping on said inner clamping elements. These internal clamping elements, when retained on the support body, define therewith a substantially cylindrical portion on which the wall is plated via the biasing means, so as to make it adopt a substantially tubular shape. When the inner clamping elements are separated from the support body, the wall is sandwiched between the outer and inner clamping elements, and the support body can be withdrawn from the orifice and outside the body of the patient, in particular by means of of the applicator.

Advantageously, the system further comprises an ejection device adapted to move the internal clamping elements between a retracted configuration in which they are at least partially housed inside the support body, and an ejected configuration in which they are extracted. outside said support body. Preferably, the ejection device is integrated with the support body. It can also be controlled by means of the applicator.

Preferably, each connecting element comprises a portion associated with a respective internal clamping element, the system further comprising a cutting device adapted to cut the connecting elements between the inner clamping elements and the first ends of said connecting elements. Preferably, the cutting device is integrated in the support body. It can also be controlled by means of the applicator.

Advantageously, it is possible to dimension the internal clamping elements so that, after removal of the support body, they are held together by mutual contact in a circular configuration.

In addition or alternatively, there may be provided a holding member adapted to maintain the inner clamping elements and / or the outer clamping elements in a circular configuration after removal of the support body.

Thus, thanks to these arrangements, it will be possible to prepare the orifice made in the wall so as to form thereon a tubular portion on which a hollow conduit, organic or not, may be attached.

Furthermore, according to this first aspect, the invention also relates to a method for preparing an orifice arranged on an organic wall, a method according to which:

- There is a support body defining a longitudinal axis and having a proximal portion and a distal portion;

- there are also external clamping elements;

the distal portion of the support body is introduced through the orifice; the external clamping elements in the corolla are unfolded with respect to the support body, said outer clamping elements being distributed in the circumferential direction, and covering, around said orifice, portions of an annular surface of said organic wall;

the outer clamping elements are urged to tighten and juxtapose said external clamping elements on said support body so as to progressively deform said annular surface so as, firstly, to shape on said organic wall a tubular portion extending along longitudinal axis and, on the other hand, form an anchor flange consisting of external clamping elements.

According to an advantageous arrangement, in the method for preparing an orifice arranged on an organic wall according to the invention, the support body releasably supporting internal clamping elements aligned angularly in the circumferential direction with the external clamping elements, is solicited. the outer clamping members for tightening and juxtaposing said outer clamping elements on said inner clamping elements.

Preferably, in the method for preparing an orifice arranged on an organic wall according to the invention, the internal clamping elements are moved between a retracted configuration in which they are at least partially housed inside the support body, and a ejected configuration in which they are extracted outside said support body.

More preferably, in the method for preparing an orifice arranged on an organic wall according to the invention, each connecting element comprising a portion associated with an associated internal clamping element, the connection elements between the internal clamping elements are cut off and the first ends of said connecting elements.

Another object of the present invention is to provide an anastomosis system for reliably, reproducibly and minimally invasive the end-to-end connection of a tubular portion formed by means of the previously described system at a orifice arranged on an organic wall and a hollow organic conduit.

Thus, according to a second aspect of the present invention, there is provided a system for producing an anastomosis between an organic wall having an orifice and a hollow organic conduit, said system comprising:

a system for preparing the orifice as described above, and

a device for connecting said duct and the shaped tubular portion to the wall, said device being arranged at least partly in a proximal portion the support body adapted to be inserted into the conduit and comprising:

^* Suture elements adapted to connect the inner and outer clamping elements and each having a first end connected to a clamping device and a second end adapted to be retained on an outer clamping member associated, and;

^* A suturing device adapted to move the second end of each suture element between a retracted configuration wherein said second end is located at a radial distance from the longitudinal axis smaller than the inner radius of said duct, and an anchored configuration wherein said second end is retained on an associated external clamping element after passing through the conduit from the inside to the outside.

Thanks to these arrangements, an end-to-end connection of the hollow organic duct and the tubular portion formed on the organic wall is carried out, so as to establish a direct contact between their respective mucosa, which is particularly advantageous in terms of healing and complete and reliable recovery of communication between the two organs, especially between the bladder and the urethra of the patient.

The suture elements connect the outer clamping members and the support body through the conduit. These suture elements are preferably flexible. They can advantageously be in the form of son, made for example of a bio-resorbable material.

Advantageously, the system further comprises a control probe of the device for connecting the hollow organic conduit and the tubular portion formed on the wall. This probe is adapted to be introduced into the hollow conduit, and to be removably connected to the proximal portion of the support body to at least partially control said device, in particular from outside the body of the patient.

The clamping device can advantageously be housed inside the support body and controlled from the control probe. Alternatively, the clamping device can be carried and controlled by the probe.

Advantageously, it can be provided that the clamping device is provided with a force limitation system for limiting the clamping force of the anastomosis. Thus, the risk of injury to the organic tissues is minimized due to over-tightening of the suture elements that can lead to stenosis at the anastomosis area. Preferably, there can be provided a non-return device between the suture elements and the internal clamping elements, said device being adapted to prevent loosening of the suture elements when the actuation of the clamping device ceases.

In preferred embodiments of the invention, one or more of the following provisions may also be used:

each suture element comprises a portion associated with a respective internal clamping member, the system further comprising a cutting device adapted to sever the suture elements between the inner clamping members and the first ends of said suture elements. Advantageously, this cutting device is the same as the cutting device described above in connection with the preparation system and for cutting the connecting elements;

the suture device is further adapted to move the second end of the suture elements between the retracted configuration and the anchored configuration through an expanded intermediate configuration in which the said second end is opposite a corresponding anchoring portion; provided on the associated external clamping element;

the suturing device comprises elastically flexible elements, aligned angularly in the circumferential direction with the inner and outer clamping elements, axially movable inside the support body, releasably supporting the second end of a suture element; associated and adapted to cooperate with associated ramps provided in the support body so as to move said second end between the retracted configuration and the anchored configuration;

the second ends of the suture elements are provided with an anchoring element adapted to cooperate with a corresponding anchoring portion provided on the outer clamping elements to retain said second ends on said external clamping elements when they are located. in anchored configuration, after crossing the conduit;

the flexible elements and / or the anchoring elements fitted to the second ends of the suture elements have a point adapted to perforate the duct when said second ends pass from their retracted configuration to their anchored configuration;

- The ramps are axially movable inside the support body between a first and a second axial positions, the passage of said ramps of the first axial position to the second axial position causing the passage of the second end of the suture elements of the intermediate configuration to the anchored configuration by elastic return of the flexible elements.

Furthermore, according to this second aspect, the invention also relates to a method for producing an anastomosis between an organic wall having an orifice and a hollow organic conduit, a method according to which:

the orifice arranged on the wall is prepared according to the method according to the first aspect of the invention;

at least part of the proximal portion of the support body is introduced into the duct;

suture elements are provided adapted to connect the inner and outer clamping elements and each having a first end connected to a clamping device and a second end adapted to be retained on an associated external clamping element, and;

the second end of each suture element is moved between a retracted configuration in which said second end is at a radial distance from the longitudinal axis less than the inside radius of said duct, and an anchored configuration in which said second end is retained on an associated external clamping element after passing through the conduit from the inside to the outside.

According to an advantageous arrangement, in the method for producing an anastomosis between an organic wall having an orifice and a hollow organic conduit according to the invention, each suture element comprising a portion associated with a respective internal clamping element, the elements of the suturing between the inner clamping members and the first ends of said suture elements.

Thanks to these arrangements, the anastomosis carried out by means of the system according to the invention is maintained, after removal of the support body, by means of the suture elements connecting the internal clamping elements to the external clamping elements through the hollow organic conduit. from the inside to the outside in the radial direction and straddling the anastomosis zone, said inner and outer clamping members being held together on the wall by means of the connecting members passing through the wall, to define thereon a tubular portion. In this way, the respective banks of the hollow organic duct and the tubular portion formed on the organic wall can be made contiguous, in the tubular extension of one another, forming a direct contact interface between their respective mucosa. Particularly advantageously, the external clamping elements, the internal clamping elements, the connecting elements and / or the suture elements are made of a bio-absorbable material, that is to say a material that can be absorbed. under the physico-chemical action of living tissues in contact with which this material is placed. By way of example, the material constituting these elements may be a bio-resorbable polymer, such as polyacetic acid (PLA, PLLA), polyglycolic acid (PGA) or polydioxanone (PDO).

Thus, the elements left in place inside the body of the patient following the preparation of the orifice formed in the organic wall made by means of the system according to the first aspect of the present invention, or following the anastomosis between said wall and the hollow organic conduit made by means of the system according to the second aspect of the present invention, will be absorbed by contact with the organic tissues, as well as with the surrounding fluids, and it will not be necessary to provide for a subsequent intervention to remove these elements.

Finally, the invention also provides the case where a tubular portion is formed on the organic wall by another means than by means of the preparation system mentioned above.

Thus, according to a second subject, the present invention proposes a system for producing an anastomosis between an organic wall having an orifice and a hollow organic conduit, said system comprising:

a support body defining a longitudinal axis and adapted to be introduced into the conduit and through the orifice;

at least one external clamping element defining with said body a tubular portion on the wall and forming an anchoring flange;

a device for connecting said duct and said defined tubular portion to the wall, said device comprising:

^* At least one suture member adapted to connect the outer clamping member to the support body and having a first end connected to a clamping device and a second end, said second end being adapted to be retained on the clamping member outside, and;

^* A suturing device adapted to move the second end of the suture member between a retracted configuration wherein said second end is located at a radial distance from the longitudinal axis smaller than the inner radius of said duct, and an anchored configuration wherein said second end is retained on the outer clamping element after passing through the conduit from the inside to the outside.

Thanks to these arrangements, an end-to-end connection of the hollow organic duct and the tubular portion defined on the organic wall is carried out, so as to establish a direct contact between their respective mucosa, which is particularly advantageous in terms of healing and complete and reliable recovery of communication between the two organs, especially between the bladder and the urethra of the patient.

The suture member connects the outer clamping member and the support body through the conduit. This suture element is preferably flexible. It may advantageously be in the form of a wire, made for example of a bio-resorbable material.

the suturing device comprises at least one flexible element that is elastically mobile axially inside the support body, releasably releasably supporting the second end of the suture element and adapted to cooperate with a ramp provided in the support body of moving said second end between the retracted configuration and the anchored configuration;

- The ramp is movable axially within the support body between a first and a second axial positions, the passage of said ramp from the first axial position to the second axial position causing the passage of the second end of the suture elements. the intermediate configuration to the anchored configuration by elastic return of the flexible element;

- The support body releasably supports at least one inner clamping member, and the suture member is adapted to connect the outer clamping member and said inner clamping member.

the system further comprises an ejection device adapted to move the inner clamping element between a retracted configuration in which it is at least partially housed inside the support body, and an ejected configuration wherein it is extracted outside said support body.

each suture element comprises a portion associated with a respective internal clamping member, the system further comprising a cutting device adapted to sever the suture elements between the inner clamping members and the first ends of said suture members;

- The system further comprises at least one connecting element adapted to connect the outer clamping member to the support body to form the anchor flange;

- The system further comprises a traction device of the connecting element and wherein said connecting element has a first end connected to the traction device and a second end adapted to be retained on an external clamping element;

the system further comprises a traversing and anchoring device adapted to move the second end of the connecting element between a retracted configuration in which said second end is at a radial distance from the longitudinal axis less than the radius of the orifice and an anchored configuration wherein said second end is retained on an associated external clamping member after passing through the wall.

Advantageously, this system may comprise a single control element adapted to control the different devices during a single anastomosis operating phase. This control element will thus include, for example, all the control functionalities of the applicator and of the probe implemented in the context of the first subject of the invention.

Furthermore, according to this second subject, the invention also relates to a method for producing an anastomosis between an organic wall having an orifice and a hollow organic conduit, a method according to which:

- There is a support body defining a longitudinal axis;

the support body is introduced inside the conduit and through the orifice;

at least one suture element adapted to connect the external clamping element to the support body and having a first end connected to a clamping device and a second end, said second end being adapted to be retained on the external clamping element, and; the second end of the suture element is moved between a retracted configuration in which said second end is at a radial distance from the longitudinal axis less than the inside radius of said duct, and an anchored configuration in which said second end is retained on the outer clamping element after passing through the conduit from the inside to the outside.

Other features and advantages of the invention will become apparent from the following description of one of its embodiments, given by way of non-limiting example, with reference to the accompanying drawings.

On the drawings:

FIG. 1 is a schematic sectional view of an organic wall having an orifice, in this case the wall of a bladder of a patient having undergone a prostatectomy, and a hollow organic conduit, in this case the urethra of the patient, between which must be performed anastomosis;

FIG. 2 is a schematic sectional view of the wall of the bladder on which a tubular portion has been formed at the orifice for an end-to-end anastomosis with the patient's urethra;

FIG. 3 is a perspective view of a complete anastomosis system comprising a system for preparing the orifice on the wall of the bladder according to a first embodiment of the invention;

FIG. 4 is an exploded perspective view of the support body according to the first embodiment of the invention;

FIG. 5 illustrates in perspective the system for preparing the orifice on the wall of the bladder according to the first embodiment of the invention, before insertion through the orifice;

FIGS. 5a to 5f are half longitudinal sectional views along line VV of FIG. 5, intended to illustrate the different successive phases of preparation of the orifice formed on the wall by means of the system according to the first embodiment of FIG. the invention;

FIG. 6 is a perspective view of the wall of the bladder on which a tubular portion has been formed at its orifice and ready to be reconnected to the patient's urethra;

FIG. 7 is an exploded perspective view of the support body according to a second embodiment of the invention;

FIG. 8 is a view similar to that of FIG. 5, intended to illustrate the system for preparing the orifice on the organic wall according to the second embodiment of the invention, before insertion through the orifice;

FIGS. 8a to 8f are half longitudinal section views along the line VIII-VIII of FIG. 8, intended to illustrate the different successive phases of preparation of the orifice formed on the wall by means of the system according to the second embodiment of FIG. embodiment of the invention;

FIG. 9 is a schematic view in elevation and partially in section illustrating a first step of use of the anastomosis system according to the invention, associated with a patient's urethra intended to be anastomosed or reconnected to the tubular portion formed on the wall of the bladder by means of the preparation system according to the first embodiment of the invention;

FIGS. 10a to 10c are half longitudinal sectional views along the line IX-IX of FIG. 9, intended to illustrate the different successive phases of the anastomosis between the bladder and the patient's urethra by means of the system according to FIG. invention, the orifice of the wall of the bladder having been prepared by means of the preparation system according to the first embodiment of the invention;

- Figure 1 1 is a half longitudinal sectional view along the line IX-IX of Figure 9 similar to those of Figures 10a to 10c and to illustrate the ejection step of the internal clamping elements after anastomosis of the portion tubular formed on the bladder by means of the preparation system according to the first embodiment of the invention and the urethra of the patient, and cutting of the connecting elements and suture elements, allowing the removal of the anastomosis system according to the invention outside the body of the patient;

- Figure 12 is a half longitudinal sectional view of the wall of the bladder and urethra of the patient after anastomosis by means of the system according to the present invention and removal of said system outside the body of the patient.

In the different figures, the same references designate identical or similar elements.

FIG. 1 illustrates an organic wall P having an orifice O, as well as a hollow organic conduit C having an open end E.

In the remainder of the description, it will be considered that this wall P belongs to a bladder V and that the orifice O arranged thereon was made during a prostatectomy undergone by the patient. Moreover, the hollow organic conduit C considered in the context of the present description is the patient's urethra whose open end E, resulting from an anterior resection of the urethra in its membrane zone carried out as part of the prostatectomy, must be reconnected to the wall P of the bladder V during an operation of anastomosis to surgically restore the communication between the bladder and the terminal orifice of the urethra, opposite to the urethral meatus, debouching at this end E.

FIG. 2 schematically shows in section the wall P of the bladder V which has been deformed so as to form a tubular portion T at the orifice O, said tubular portion T being intended to be reconnected end to end, or abutment, during an operation of anastomosis at the end E of the urethra C opposite the urethral meatus.

A first objective of the present invention is to propose an SP system,

SP 'for preparing the wall P of the bladder V so as to form this tubular portion T at the orifice O.

A second objective of the present invention is to propose an SA anastomosis system for performing the end-to-end connection of the tubular portion T formed by means of the above-mentioned SP, SP 'system at the orifice O arranged on the wall P of the bladder V, and the urethra of the patient.

In FIG. 3 is shown a complete system SA for making an anastomosis between the bladder and the urethra of a patient. The anastomosis system SA comprises an SP system for preparing the orifice O of the wall P of the bladder V according to a first embodiment. This SP system includes:

a support body 1 defining a longitudinal axis X and having a proximal portion 1a and a distal portion 1b, said distal portion 1b being adapted to be introduced through the orifice O, and

an applicator 8 having a proximal control portion 8b intended to be manipulated by the surgeon, a distal portion 8a on which the proximal portion 1a of the support body 1 is intended to be connected as part of a first phase of operation, or tubularization phase, and an elongate central portion 8c.

The anastomosis system SA further comprises a probe 9 having a proximal portion 9b of control to be manipulated by the surgeon, a distal portion 9a on which the proximal portion 1a of the support body 1 is intended to be connected in the part of a second operative phase, or anastomosis phase, and an elongate central portion 9c.

In the embodiment illustrated in FIG. 3, the distal portion 8a of the applicator 8 has a housing 8d designed to receive the proximal portion 1a of the support body 1. Furthermore, the distal portion 8a of the applicator 8 is equipped with a deployment device 2 which will be explained in more detail later.

As also visible in Figure 3, the distal portion 9a of the probe 9 has a housing 9d provided to receive the proximal portion 1a of the support body 1. This distal portion 9a also has a plurality of slots 95 opening into the central housing 9d whose utility will be detailed in the following description.

In a manner not shown in detail in the figures, in one or other of the illustrated embodiments of the preparation system SP, the distal portions 8a, 9 of the applicator 8 and the probe 9 are shaped to be assembled. in a complementary manner to the proximal end of the support body 1, 1 ', for control purposes of different devices arranged on or inside said support body 1, 1'. Various embodiments can be envisaged for this purpose, as long as the applicator 8 and the probe 9 are able to transmit control movements to these devices since their proximal portion 8b, 9b visible in FIG. 3. In the example shown, these proximal portions 8b, 9b is in the form of a manual actuator comprising a handle 84, 94 and various control elements, such as a trigger 81, 91, a manipulable wheel 82, 92 in rotation and in translation or a locking button 83, 93.

Alternatively, it could be provided that the proximal portion of the applicator 8 and / or the probe 9 is mechanically connected to an interface connected to a robotic arm, allowing control of the computer-controlled system or systems placed under the supervision of the surgeon, particularly in the context of remote and computer-assisted surgery.

FIG. 4 is an exploded perspective view of the support body 1 belonging to the anastomosis system SA comprising a preparation system SP according to a first embodiment of the invention.

In this figure, the connecting elements 33 intended to pass through the wall P of the bladder V, and the suture elements 44 intended to pass through the urethra, have not been represented for the sake of clarity; these elements, which are in the form of son made of bio-resorbable materials, will be visible in particular in Figures 5a to 5f, 10a to 10f, 1 1 and 12.

As shown in Figure 4, the support body 1 is made in two parts 101, 102 movable relative to each other along the longitudinal axis X.

The first part, which will be considered here as the fixed part, presents itself in the form of a generally cylindrical element 101 extending along the longitudinal axis X and comprising two hollow cylindrical portions of different outer diameters, namely a proximal portion 105 whose outer diameter substantially corresponds to the inside diameter of the housings 8d, 9d receiving means provided at the distal portions 8a, 9a of the applicator 8 and the probe 9, and a distal portion 103 whose outer diameter is greater than that of the proximal portion 105.

The proximal portion 105 is axially open on the outside at its proximal end and has on its periphery a plurality of radial slots 1051, here six in number, communicating its interior space with the outside. In the distal extension of these slots 1051, the proximal portion 105 has on its outer surface grooves 1052 that do not open into the internal space of the proximal portion 105 in the radial direction and whose bottom has a longitudinal groove 1053 opening axially to the inside of a corresponding slot 1051 on the proximal side, and inside the inner space of the distal portion 103 on the distal side.

The distal portion 103 is axially open on the outside at its distal end and defines an interior space communicating with the internal space of the proximal portion 105. The grooves 1052 formed in the proximal portion 105 extend axially in a proximal portion 1030 of the distal portion 103 and define a plurality of housing 1031 whose utility will be detailed later. These grooves 1052 stop axially inside the proximal portion 1030 of the distal portion 103. Furthermore, the housing 1031 has a through opening in their bottom communicating the interior space of the distal portion 103 with the outside so as to provide a space e passage for each associated connecting wire 33 as visible in particular in Figure 5a.

The proximal portion 1030 of the distal portion 103 also has on its outer surface notches 1032 extending in the axial extension of the housings 1031. The distal portion 103 further has an annular groove 1033 and a distal portion 1034. The notches 1032 open axially into a housing 1031 proximal and inside the groove 1033 distally.

The distal portion 103 also has on its periphery a plurality of radial slots 1035 aligned in the circumferential direction with the slots 1051, communicating in the radial direction the interior space of the distal portion 103 with the outside, and opening axially at level of the distal end of this Distal portion 103. The utility of these radial slots 1035 will be described in more detail later.

The proximal portion 1030 of the distal portion 103 has a generally cylindrical outer surface in which the housings 1031 are provided to releasably receive internal clamping members 11 here in the form of inner wafers made of a biological material. resorbable, said pads 1 1 being for example received clamping inside said housing 1031.

Still with reference to FIG. 4, the second part of the support body 102, which will here be considered as the movable part, comprises a generally cylindrical element, those 104 having a ogival-shaped distal end 1041, and a rod 106 extending along the longitudinal axis X whose distal end 1061 is connected to the cylindrical element 104, for example by screwing or by press fitting. The rod 106 further has a proximal end 1062 adapted to be inserted along the longitudinal axis X through the fixed portion 101 of the support body 1, so as to protrude in the proximal direction beyond the proximal end of said fixed portion 101, and intended to be connected to the applicator 8 for purposes of controlling the displacement of the movable portion 102 relative to the fixed portion 101.

The cylindrical element 104 has on its periphery a plurality of radial slots 1042, here six in number, communicating its interior space with the outside and aligned in the circumferential direction with the slots 1035 provided on the fixed part 101 of the body of support 1.

A traversing and anchoring device 3 is arranged between the fixed part 101 and the movable part 102 of the support body 1. This device 3 comprises a plurality of needles 31 whose proximal end releasably supports anchoring elements 32 in the form of hollow cylinders received for example with clamping on the distal end of the needle 31 to which it is associated, and on which are fixed the second ends 332 of the connecting son 33, the first end 331 of said son 33 being connected to a traction device advantageously provided at the applicator. Advantageously, the hollow anchoring cylinders 32 are made of a bio-resorbable material.

Each of the needles 31 is supported in a distal portion by a plurality of links, here a proximal link 34 and two distal links 35, articulated to define a deformable parallelogram mechanism. In this Indeed, the distal rods 35 supporting each needle 31 are articulated on the one hand on the movable portion 102 of the support body 1, and secondly on the distal portion of the needle 31 which they support; the proximal link 34 is articulated on the one hand on a slide 36 movable in translation along the rod 106 and on the other hand on the distal portion of the needle 31 that it supports. An elastic element here in the form of a frustoconical helical spring 37 is also provided to be compressed at least over part of the axial stroke of the slide 36.

The slider 36 also has a plurality of radial slots 365 permitting a certain clearance of the proximal links 34. The radial slits 1042 provided on the cylindrical member 104 of the movable portion 102 of the support body 1 allow a certain clearance distal links 35.

As also visible in this Figure 4, the support body 1 concentrically receives a hollow rod 70 adapted to be threaded onto the rod 106 of the movable portion 102 of the support body 1, and to be rotatable about the longitudinal axis X with respect to said rod 106. An annular ring 71 having a plurality of through holes 71 1 is threaded on the hollow rod 70 in a crazy manner in rotation. When the rod 70 is put in place inside the proximal portion 101 of the support body 1, the ring 71 is press-fitted to a corresponding bearing surface of said proximal portion 101. Furthermore, this hollow rod 70 is integral with a winding mandrel 72 having a plurality of passage holes and attachment 721 for the suture son 44 (not shown in Figure 4).

The hollow stem 70 has a distal end 701 and a proximal end 702 adapted to be inserted along the longitudinal axis X through the fixed portion 101 of the support body 1, so as to protrude in the proximal direction to the beyond the proximal end of said fixed portion 101, and intended to be connected to the applicator 8 for the purpose of controlling the rod 70. The rod 70 and the winding mandrel 72 belong to a clamping device 7 of which the operation will be detailed later.

In the example shown, the slider 36 of the traversing and anchoring device 3 is mounted to move in translation along the longitudinal axis on a distal portion of the hollow rod 70, and the compression spring 37 bears on one face. radial winding mandrel 72.

Still in this FIG. 4, it can be observed that the support body 1 also concentrically receives a stepped element of overall shape. cylindrical 50, movable in translation along the longitudinal axis X relative to the fixed portion 101 of the support body 1. This stepped element 50 is adapted to be threaded onto the hollow rod 70 and has three cylindrical portions of different outer diameters, namely a proximal portion 501, a central portion 502 and a distal portion 503.

The proximal portion 501 has a proximal end 5012 adapted to be inserted along the longitudinal axis X through the fixed portion 101 of the support body 1, so as to protrude in the proximal direction beyond the end. proximal to said fixed portion 101, and intended to be connected to the applicator 8 for control purposes of the stepped element 50.

A plurality of longitudinal channels 504, circumferentially aligned with the radial slots 1035 provided on the fixed portion 101 of the support body 1, are provided on the outer surface of the proximal and central portions 501, 502. These channels 504 terminate at the distal end thereof by a ramp 505 formed in the distal portion 503 and extending radially outwardly in the radial direction to terminate at the outer surface of the distal portion 503 of the stepped element 50. This distal portion 503 has on its outer surface a plurality of radial through slots 507 aligned in the circumferential direction with the channels 504 and whose proximal ends open axially inside the ramps 505.

Furthermore, the distal portion 503 and the central portion 502 has a plurality of radial through slots 508, angularly offset with the channels 504 and defining on the distal portion 503 a plurality of corners 500 extending in the axial extension of the channels 504. At their distal end, each corner 500 has an ejection face 509 belonging to an ejection device 5 and adapted to cooperate with the inner plates 1 1 to eject them in the radial direction outside their housing 1031 like this will be described in more detail later.

Moreover, each of these ejection wedges 500 have two branches separated by a through slot 507 and connected at their distal end by a cutting blade 506 belonging to an ejection device 6.

When the stepped element 50 is put in place inside the fixed part 101 of the support body 1, the corners 500 are inserted inside the slots 1051 provided in the proximal portion 105 of the fixed part 101 of the body 1 and can move inside thereof by sliding on the bottom of the grooves 1052.

Finally, the support body 1 concentrically receives a bushing hollow 40 movable in translation along the longitudinal axis X with respect to the fixed portion 101 of the support body 1. The sleeve 40 has a proximal end 402 adapted to be inserted along the longitudinal axis X through the fixed portion 101 of the support body 1, so as to protrude in the proximal direction beyond the proximal end. of said fixed portion 101, and intended to be connected to the applicator 8 for purposes of controlling movement of the sleeve along the longitudinal axis.

This sleeve 40 is adapted to be threaded onto the proximal portion 501 of the stepped element 50 and supports a plurality of elastically flexible needles 41 adapted to be inserted inside the channels 504 of the stepped element 50 and for cooperate in operation with the ramps 505.

The distal end of each needle releasably supports anchoring elements 42 in the form of hollow cylinders received for example with clamping on the distal end of the needle 41 with which it is associated, and on which are fixed the second ends 442 of the suture threads 44, the first end 441 of said threads 44 being connected to the clamping device 7, and more precisely at the attachment orifices 721 of the winding mandrel 71.

In the embodiment illustrated in this figure 4, the sleeve 40, the needles 41 and the stepped element 50 belong to a suture device 4 which will be detailed later. Furthermore, the ejection and cutting devices 6 are here part of this suture device 4.

The sleeve 40, the needles 41 and the stepped element 50 are part of a suture device 4 whose operation will be detailed later.

Thus, in the embodiment illustrated in FIG. 4, all the elements supported by the support body 1, when they are in their initial configurations, fit inside a cylindrical envelope whose diameter corresponds to the outer diameter of the distal portion 103 of the fixed portion 101 of the support body 1. Preferably, this diameter is smaller than the diameter of the orifice O present on the wall P so as to allow the insertion of the distal portion 1a of the support body through said orifice O.

We will now describe a first phase of operation to prepare the orifice O, arranged on the wall P of the bladder, so as to form a substantially tubular portion at the level thereof, implementing the preparation system SP according to the first embodiment of the invention. For this purpose, as shown in FIG. 5, the proximal portion 1a of the support body 1 is inserted along its longitudinal axis X inside the housing 8d defined in the proximal portion 8a of the applicator 8, and the portion distal 1b of the support body 1 extends in the distal direction from said proximal portion 8a of the applicator 8.

In this FIG. 5, it can be observed that, in the first embodiment of the preparation system SP according to the invention, the distal portion 8a of the applicator supports a deployment mechanism 2 comprising a plurality of support elements 23, particularly visible in FIGS. 5a to 5f, releasably supporting external clamping elements 22 intended to be placed facing respective portions of an annular surface S of the wall P centered around the orifice O.

This deployment mechanism 2 is adapted to move the external clamping elements 22 between a retracted configuration, illustrated in FIG. 5, in which they are folded towards the longitudinal axis X on the side of the proximal end 1 a of the body. support, and an expanded configuration in which they are spaced apart from the longitudinal axis X and extend corolla substantially perpendicular thereto.

The distal portion 8a of the applicator 8, thus equipped with the support body 1 in initial configuration, and having external clamping elements 22 in folded configuration, may advantageously be inserted through a TR trocar placed on the abdominal wall of the patient, and the control of the different devices can be achieved by means of the proximal portion 8b of said applicator 8 from outside the body of the patient, typically in the context of endoscopic surgery.

The applicator 8 equipped with the support body 1 is then manipulated by the surgeon to approach the body 1 of the bladder V, until the distal portion 1a of said body is introduced through the orifice O formed in the wall P, in centering the longitudinal axis X within this hole O and first engaging the distal end 1041 therein. The ogival shape of this end 1041 facilitates this implementation.

The external clamping elements 22, here six in number, are in the form of outer plates made of a bio-resorbable material and are releasably supported on the support members 23, for example by complementarity of form.

The distal portion 8a of the applicator 8 and the proximal portion 1a of the support body 1 advantageously have indexing means for fixing said support body 1 at the end of the applicator 8 so that the outer plates, supported by the applicator 8, are aligned angularly in the circumferential direction with the inner plates 1 1 supported by the distal portion 1b of the support body 1.

Furthermore, the deployment mechanism 2 advantageously has a stop element 20 adapted to cooperate with the wall P to limit the insertion of the support body 14 through the orifice O.

As can be seen in FIGS. 4 and 5, the assembly formed of the distal portion 8a of the applicator 8 and of the support body 1 has a symmetry in rotation about the longitudinal axis X and can be broken down into a plurality of modules identical elementary elements evenly distributed in the circumferential direction. In the example shown, this assembly can be broken down into six elementary modules extending in an angular range of approximately 60 ° and each comprising in particular an inner plate 1 1, an outer plate 22, a connecting wire 33 intended to connect the inner plate 1 1 and the outer plate 22 after passing through the wall P, and a suture 44 provided for connecting the inner plate 1 1 and the outer plate 22 after passing through the urethra.

FIGS. 5a to 5f, as well as FIGS. 10a to 10f, 1 1 and 12, thus illustrate only one of these modules. The reader will understand that what is visible in these figures also applies to each of the other five modules.

Thus, Figures 5a to 5f illustrate the different steps of preparation of the orifice O by means of the preparation system SP according to the first embodiment of the invention.

In FIG. 5a, the SP system is partially illustrated in its initial configuration and placed at the level of the orifice O.

In this initial configuration of the preparation system SP, the deployment mechanism 2 is in folded configuration of the outer plate 22 which is supported by a support member 23, the traversing and anchoring device 3 is in a retracted configuration of the second end 332 of the connecting wire 33, this end 332 being located at a radial distance d1 from the longitudinal axis X less than the radius r1 of the orifice O, the inner plate 1 1 is received inside its housing 1031 provided on the support body and the ejection device 5 and cutting 6, formed here a corner 500 is in an inactive configuration.

The suture device 4 is also in a retracted configuration of the second end 442 of the suture. This device will be implemented as part of the second operative phase, or anastomosis phase, and its operation will be described later in connection with Figures 10a to 10c and 11. For the sake of clarity, the suture 44 is not shown in Figures 5a to 5f.

Returning to FIG. 5a, it can be seen that, in this first placing step, the support body 1 has been inserted through the orifice O until the abutment element 20 comes into contact with the outer surface, or surface located on the proximal side, of the wall P. This stop element 20 thus limits the insertion of the support body 1 through the orifice O. Moreover, this abutment of the stop element 20 against the wall P makes it possible to ensure the correct positioning in the axial direction of the deployment mechanism 2 of the wafer 2.

In a manner not shown in detail in the figures, the abutment element 20 is integral with the distal portion 8a of the applicator 8.

In FIG. 5a, it can be observed that the abutment element 20 rotatably supports a support element 23 which is in the form of a generally Y-shaped fork having a lower branch 231 rotatably mounted on the element of FIG. stop 20 and two upper branches 232 cooperating with a complementary cavity 222 provided on the outer plate 22 to ensure the releasable support of said plate 22 on the support member 23 and visible in particular in Figure 9. One of these upper branches 232 , as well as part of the cavity 222 are visible in FIG. 5f.

Furthermore, the lower branch 231 has on its periphery a plurality of meshing teeth adapted to cooperate with a rack provided on a distal portion of a sleeve 24 mounted to move in translation inside the distal portion 8a of the applicator. 8 and which can be controlled from the proximal portion 8b thereof. In the case of a sequenced deployment of the external clamping elements, it will be noted that the sleeve 24 may be subdivided into as many subparts as is contemplated successive sequences of deployment, each of these sub-parts being intended to control the deployment one or more clamping elements between the retracted configuration and the deployed configuration, which can be successively controlled from the proximal portion 8b of the applicator 8.

In the folded configuration of the deployment mechanism 2, the support 23 and the outer plate 22 extend substantially parallel to the longitudinal axis.

FIG. 5a also shows the path of a wire 33 to the inside of the support body 1. This wire 33 has a first end 331 adapted to be connected to a not shown traction device and integrated with the applicator 8. The wire 33 passes through the proximal portion 1a of the support body 1 within a space provided for this purpose and extends essentially along the hollow rod 70. This wire 33 then opens at a free space e provided in the support body 1 and located under the inner plate 1 1 received in its housing 1031. The connecting wire 33 then passes through the inner plate 1 1 through a through hole 1, and bifurcates again along the outer surface of the wafer January 1; it then passes through the notch 1032 and is fixed by its second end 332 on an anchoring element 32 releasably supported by a needle 31.

Referring now to Figure 5b, the sheath 24 having been moved along the arrow F1 on an axial stroke C1, by appropriate control, caused the pivoting of the support member 23, by cooperation of the teeth carried by it and the rack carried by the sheath, until reaching an expanded configuration of the outer wafer 22 in which it extends substantially perpendicular to the longitudinal axis X, facing a portion of the annular surface S of the wall P visible in FIG.

In this deployed position, an anchoring portion 220 formed in the outer plate 22 and adapted to retain the anchoring cylinder 32 on which is fixed the second end of the connecting wire 33, is at a predetermined radial distance d of the longitudinal axis X.

By moving on to FIG. 5c, a traction along the arrow F2 exerted on the rod 106 causes the moving part 102 of the support body 1 to move relative to the fixed part 101 of this body 1 in a first axial stroke up to the proximal end 1041 of the cylindrical member 104 and a distal abutment face

361 of the slider 36 come into contact. This axial stroke C2 of the movable portion 102 relative to the fixed portion 101, visible in Figure 5b, causes the deformation of the deformable parallelogram mechanism composed of the proximal link 24 and the distal rods 35. The traversing device and anchoring 3 is then in an intermediate configuration deployed, wherein the second end 332 of the connecting wire 33, is opposite the anchoring portion 220 of the outer plate 22 in the radial direction. In this position, the outer plate 22 and the second end 332 of the connecting wire 33 are opposite in the radial direction, and on either side of the wall P in the axial direction.

By continuing the movement along the arrow F3 of the rod 106, as visible in Figure 5d, it causes the displacement of the movable portion 102 relative to the fixed portion 101 in a second axial stroke, by driving the slide 36 by radial contact with the cylindrical member 104 and compressing the spring 37 bearing d partly on a proximal face of the slide 36 and secondly on a radial face of the mandrel 71. In doing so, the needle 31 is driven via the links 34, 35 on the second axial stroke.

This second axial stroke can be defined in different ways, for example as the stroke necessary to move the spring 37 from its free state, that is to say not subject to any constraint, to a compressed state in which its turns are joined. . In any event, this second axial stroke is dimensioned so that the second end 332 of the connecting wire 33 and the anchor cylinder 32 which supports it passes right through the wall P, and the outer plate 22 in passing through its anchoring portion 220. For this purpose, in the illustrated embodiment, the needle 31 has on its proximal end a tip 310 adapted to perforate the wall P.

By releasing the tensile force exerted on the rod 106, the expansion of the spring causes the return of the traversing and anchoring device 3 in its configuration shown in Figure 5c. During this return movement, the needle 31 drops the anchoring cylinder 32 on which is fixed the second end 332 of the connecting wire 33, the cylinder 32 being anchored in the anchoring portion 220 of the plate 22. Non-limiting example illustrates an example of cooperation between the anchoring cylinder 32 and the anchoring portion 220.

Then, by pushing on the rod according to the arrow F4 visible in FIG. 5e, the traversing and anchoring device 3 is brought back into its retracted configuration.

We then find ourselves in the configuration illustrated in FIG. 5e, in which the second end 332 of the connecting wire 33 is anchored by means of the anchoring cylinder 32 in the anchoring portion 220 of the outer plate 22 after passing through the P wall

Alternatively, it could be provided that the two aforementioned axial strokes cause a compression of the spring 37; thus, by releasing the rod 106 from the configuration of FIG. 5d, the traversing and anchoring device 3 would be brought directly back into its retracted configuration by the expansion of the spring 37.

At this stage, and as illustrated in FIG. 5f, a traction force is exerted along the arrow F5 on the first end 331 of the connecting wire 33 by means of the traction device arranged in the applicator 8. The traction exerted on this first end 331 is transmitted by the wire 33 to the second end 332 anchored in the outer plate 22 and causes at first the pivoting of the support member 23 carrying the outer plate 22 towards the longitudinal axis X, the distal side of the support body 1. In doing so, the outer plate 22 begins to deform the wall P by contact with a portion of the annular surface S surrounding the orifice O.

By continuing the traction on the first end 331 of the connecting wire 33, it causes the release of the releasable attachment of the outer plate 22 on the support member 23, the upper branches 232 of the support member 23, initially received for example with tightening in the complementary cavity 222 of the outer plate 22, coming out of said cavity 222.

By pulling even more on the first end 331 of the connecting wire 33, the outer plate 22 deforms the wall P being tightened on the inner plate 1 1 housed in the support body 1; the wall P is then sandwiched between said inner plate 1 1 and said outer plate 22.

Advantageously, a non-return device is provided between the connecting wire 33 and the inner plate 1 1, this device for preventing the loosening of the outer plate 22 on the inner plate 1 1 when one stops shooting on the first end 331 of the connecting wire 33. For this purpose, the connecting wire 33 may for example have a beaded portion cooperating with the through hole 1 10 provided on the inner plate 1 1 to pass the connecting wire 33 to prevent the portion of wire 33 connecting the outer plate 22 to the inner plate 1 1 to relax.

Subsequently or simultaneously, the deployment mechanism 2, having dropped the outer plate 22, is brought back into its retracted configuration illustrated in Figure 5a by moving the sleeve in the distal direction.

The applicator 8 is then disconnected from the support body 1 and can be extracted outside the body of the patient by passing through the TR trocar.

In FIG. 6, all six elementary modules of the support body 1, to which must be added the six corresponding external plates, are represented after the step illustrated in FIG. 5f and disconnection and removal of the applicator

8. In this Figure 6, we can see in perspective the tubular portion T formed on the wall P around the orifice O by means of the preparation system SP according to the first embodiment of the invention. This tubular portion T extends here between the outer plates 22 and the cylindrical portion of the support body 1 receiving the inner plates 1 January. Thus, in this embodiment, the biasing means arranged to tighten and juxtapose the outer plates 22 on the support body, and more specifically on the inner plates 1 1 supported by the support body 1, in order to gradually deform the surface annular S of the wall P centered around the orifice O to, firstly, shape on the organic wall P a tubular portion T extending along the longitudinal axis X, and, on the other hand, form a flange anchoring consisting of said outer plates 22, consist of connecting son 33 associated with a traction device of these son 33.

At this stage, it would be possible to actuate the ejection device 5 of the inner plates 1 1 outside the support body, as well as the cutting device 6 of the connecting wires 33 to be able to extract the support body 1 outside the body of the patient, leaving inside the latter only the inner and outer plates 1 1, 22 each connected by a connecting wire 33 whose second end 332 is secured to an anchor cylinder 32, all these elements being preferably made of a bio-resorbable material.

The tubular portion T formed on the wall could then be held in shape by mutual contact of the inner plates 1 1 to each other in a circular configuration, or by means of a holding element, for example in the form of a telescopic ring notched, maintaining the inner plates 1 1 and / or external 22 in a circular configuration, and put in place after removal of the support body 1.

One could then imagine that one can use the anchor flange formed by the outer plates 22 to reconnect to the tubular portion T formed a hollow conduit, organic or not, for example by a manual intervention of the surgeon.

Nevertheless, in the context of the present detailed description, the first tubularization phase of operation is followed by a second anastomosis operative phase for end-to-end reconnection of the patient's urethra to the tubular portion T formed at the level of the orifice made in the wall P of the bladder, by means of the SA anastomosis system proposed by the invention. The ejection and cutting devices 6 will thus be actuated only after this reconnection is performed as will be described in more detail below with reference to FIGS. 9, 10a to 10c, 11 and 12. Alternatively, it could be provided to cut the connecting son 33 by means of an ad hoc additional tool before proceeding to the second anastomosis operative phase. Before that, the invention proposes a second embodiment of a preparation system SP 'of the wall P of the bladder for forming thereon a tubular portion T extending from its orifice O.

This preparation system SP 'according to the second embodiment implements an applicator 8' identical to the applicator 8 of the first embodiment, with the exception of the deployment device 2 'which differs from that of the first embodiment. and whose operation will be detailed, in particular in relation to FIGS. 8a to 8f.

In this second embodiment, and as visible in particular in Figure 7, the support body 1 'is made of a single hollow portion and of generally cylindrical shape.

The sleeve 40 ', the needles 41' and the stepped element 50 'which appear in this figure 7 belong to a suture device 4', and have substantially the same characteristics as the sleeve 40, the needles 41 and the step element 50 described in the context of the first embodiment, in connection with Figure 4; therefore they will not be described further in the context of this second embodiment.

Moreover, in the same way, the ejection devices 5 'and cutting devices 6' visible in FIG. 7 and forming part of the suture device 4 ', are similar to the ejection and cutting devices 6 and have been described in the context of the first embodiment, in connection with Figure 4; therefore they will not be described further in the context of this second embodiment.

For these different elements of the second embodiment, we will use the same reference signs as in the first embodiment, to which we will add the sign '.

In FIG. 7, the connecting elements 33 'intended to pass through the wall P of the bladder V, and the suture elements 44' intended to pass through the urethra have not been shown for the sake of clarity; these elements, which are in the form of son made of bio-resorbable materials, will be visible in particular in Figures 8a to 8f, 10a to 10f, 1 1 and 12.

With reference to this FIG. 7, the support body 1 'presents a part proximal 105 'substantially identical to the proximal portion 105' of the fixed portion 101 of the support body 1 described in detail particularly in connection with Figure 4 and will not be detailed further in the context of the description of the second embodiment.

In this second embodiment, the support body 1 'has a distal portion 103' comprising a proximal portion 1030 'similar to the proximal portion 1030 of the distal portion 103 described in the context of the first embodiment. This proximal portion 1030 'essentially defines receiving housings 1031' for receiving inner plates 1 'open radially outwardly and communicating with the interior space of the support body so as to provide a passage space e' for each connecting wire 33 'associated as visible in particular in Figure 8a.

The distal portion 103 'of the support body further has a distal portion 1034' of generally frustoconical shape whose diameter is reduced in the direction distal. This frustoconical distal portion 1034 'has a osseous distal end 1036'. The exterior design of this frustoconical distal portion 1034 'facilitates the insertion of the distal portion 103 of the support body through the orifice O.

This distal portion 103 'also has a plurality of through radial slots 1033' communicating with the outside the interior space it defined. The utility of these slots 1031 'will be detailed later.

The support body 1 'according to the second embodiment concentrically receives the suture device 4', mentioned previously, not described in detail, as well as a clamping device 7 'and a traversing and anchoring device 3 .

The traversing and anchoring device 3 'is in the form of a rod 106' extending along the longitudinal axis X and movable in translation along this axis relative to the support body 1 '. This rod 106 'has a distal heel 1061' supporting a plurality of elastically flexible needles 31, said needles 31 each releasably supporting on their proximal end an anchoring element 32 'on which is fixed the second end 332' d ' an associated wire 33 '. Each anchoring element 32 'is here in the form of a cylinder whose proximal end is frustoconical and which has a housing for receiving the proximal end of the needle 31' with which it is associated.

Rod 106 'further has a proximal end 1062' adapted to protrude in the proximal direction beyond the proximal end of the shaft. support body, and intended to be connected to the applicator 8 'for displacement control purposes of said rod 106'.

The traversing and anchoring device 3 'according to this second embodiment further comprises an element 36' defining a ramp 360 'for the flexible needles 31'; it is here in the form of an element of revolution having a distal end 361 'of smaller diameter and a proximal end 362' of larger diameter. In other words, the diameter of the element 36 'progressively increases in the proximal direction between its distal end 361' and its proximal end 362 '.

This element 36 'is mounted integrally on a distal end

701 'a winding mandrel formed in this second embodiment of a hollow rod 70' terminating at its distal end by an annular flange 72 having a plurality of passage holes and attachment 721 'for suture threads 44 '(not shown in FIG. 7).

This hollow rod 70 'is adapted to be threaded onto the rod 106' and to be rotatable thereon about the longitudinal axis. Once in place with the stem 106 'within the support body 1', the proximal end 702 'of this hollow stem 70' protrudes in the proximal direction beyond the proximal end. of the support body 1 ', and is intended to be connected to the applicator 8' for the purpose of controlling the rod 70 '.

Finally, as always visible in this figure 7, the stepped element 50 'is adapted to be threaded on the hollow rod 70', and the sleeve 40 'carrying the flexible needles 41' is adapted to be threaded onto the step element 50 .

The assembly thus formed comprises the traversing and anchoring device 3 ', the clamping device 7' and the suture device 4 '. This assembly is intended to be inserted inside the support body 1 '.

Once in place within the support body 1 ', the proximal ends 402', 5012 'of the sleeve 40' and the stepped element 50 'protrude in the proximal direction beyond the end. proximal of the support body 1 ', is intended to be connected to the applicator 8' for the purpose of controlling the suture device 4 '.

Thus, in the embodiment illustrated in FIG. 7, all the elements supported by the support body 1 ', when they are in their initial configurations, fit inside a cylindrical envelope of which the diameter corresponds to the largest outside diameter of the distal portion 103 'of the support body 1 '. Preferably, this diameter is smaller than the diameter of the orifice O present on the wall P so as to allow the insertion of the distal portion 1 a 'of the support body through said orifice O. A first phase will now be described. procedure for preparing the orifice O, arranged on the wall P of the bladder, so as to form a substantially tubular portion at the latter, implementing the preparation system SP 'according to the second embodiment of the invention. 'invention.

For this purpose, as shown in FIG. 8, the proximal portion 1 a 'of the support body 1' is inserted along its longitudinal axis X inside the housing 8d 'defined in the proximal portion 8a' of the applicator 8 ', and the distal portion 1b' of the support body 1 'extends distally from said proximal portion 8a' of the applicator 8 '.

In this FIG. 8, it can be observed that, in the second embodiment of the preparation system SP 'according to the invention, the distal portion 8a' of the applicator supports a deployment mechanism 2 'comprising a plurality of elements of FIG. 23 'support, visible in particular in Figures 8a to 8f, releasably support external clamping elements 22' intended to be placed opposite and then in contact with respective portions of an annular surface S of the wall P centered around the orifice O.

This deployment mechanism 2 'is adapted to move the outer clamping elements 22' between a retracted configuration, illustrated in FIG. 8, in which they are folded towards the longitudinal axis X on the side of the proximal end 1a. 1 ', a deployed configuration in which they are spaced apart from the longitudinal axis X and extend in a corolla substantially perpendicular thereto, and a folded configuration in which they are folded in the direction of the longitudinal axis X on the side of the distal end of the support body 1 'by deforming the wall P, as will be explained in more detail in connection with Figures 8a to 8f.

The distal portion 8a 'of the applicator 8', thus equipped with the support body 1 'in initial configuration, and having external clamping elements 22' in folded configuration, can advantageously be inserted through a TR trocar placed on the abdominal wall of the patient, and the control of the various devices can be achieved by means of the proximal portion 8b 'of said applicator 8' from outside the body of the patient, typically in the context of surgery Endoscopic.

The applicator 8 'equipped with the support body 1' is then manipulated by the surgeon to approach the body 1 'of the bladder V, until the distal portion 1a' of said body is introduced through the orifice O formed in the wall P, centering the longitudinal axis X inside this hole O and first engaging the distal end 1036 '. The ogival shape of this end 1036 'and the frustoconical shape 1034' provided on the support body 1 'facilitates this implementation.

The external clamping elements 22 ', here in number of six, are in the form of outer plates made of a bio-resorbable material and are releasably supported on the support members 23', for example by complementarity of shape.

The distal portion 8a 'of the applicator 8' and the proximal portion 1a 'of the support body 1' advantageously have indexing means for fixing said support body 1 'to the end of the applicator 8 of so that the outer plates 22 ', supported by the applicator 8', are aligned angularly in the circumferential direction with the inner plates 1 'supported by the distal portion 1b' of the support body 1 '.

As can be seen in FIGS. 7 and 8, the assembly formed of the distal portion 8a 'of the applicator 8' and of the support body 1 'has a symmetry in rotation about the longitudinal axis X and can be decomposed into a a plurality of identical elementary modules regularly distributed in the circumferential direction. In the example shown, this assembly can be decomposed into six elementary modules extending in an angular range of about 60 ° and each including an inner plate 1 ', an outer plate 22', a connecting wire 33 ' provided for connecting the inner wafer 11 'and the outer wafer 22' after passing through the wall P, and a suture 44 'provided for connecting the inner wafer 11' and the outer wafer 22 'after passing through the urethra .

FIGS. 8a to 8f thus illustrate only one of these modules. The reader will understand that what is visible in these figures also applies to each of the other five modules.

Thus, Figures 8a to 8f illustrate the different steps of preparing the orifice O by means of the preparation system SP 'according to the second embodiment of the invention.

In FIG. 8a, the system SP 'has been partially illustrated in its initial configuration and put in place at the orifice O. In this initial configuration of the preparation system SP ', the deployment mechanism 2' is in folded configuration of the outer plate 22 'which is supported by a support member 23', the traversing and anchoring device 3 'is found in retracted configuration of the second end 332 'of the connecting wire 33', this end 332 'being at a radial distance d1' of the longitudinal axis X less than the radius r1 of the orifice O, the inner plate 1 1 is received inside its housing 1031 'provided on the support body 1' and the ejection device 5 'and cutting 6', here formed by a corner 500 ', is in an inactive configuration.

The suture device 4 'is also in the retracted configuration of the second end 442' of the suture. This device will be implemented as part of the second operative phase, or anastomosis phase, and its operation will be described later in connection with Figures 10a to 10c and 11. For the sake of clarity, the suture 44 'is not shown in Figures 8a to 8f.

Returning to FIG. 8a, it can be seen that, in this first placing step, the support body 1 'has been inserted through the orifice O until a positioning element 20' arrives in the vicinity the outer surface, or proximal surface, of the P-wall.

In a manner not shown in detail in the figures, the positioning element 20 'is integral with the distal portion 8a' of the applicator 8 '.

In FIG. 8a, it can be observed that the positioning element 20 'rotatably supports a support element 23' which is in the form of a generally Y-shaped fork having a lower branch 231 'rotatably mounted on the positioning element 20 'and two upper branches 232' cooperating with a complementary cavity 222 'provided on the outer plate 22' to ensure the releasable support of said wafer 22 'on the support member 23'. One of these upper branches 232 ', as well as part of the cavity 222' are visible in FIG. 8f.

Furthermore, the lower branch 231 'has on its periphery a plurality of meshing teeth adapted to cooperate with a rack provided on a distal portion of a sleeve 24' mounted to be movable in translation inside the distal portion 8a 'of the applicator 8 'and which can be controlled from the proximal portion 8b' thereof. In the case of a sequenced deployment of the external clamping elements, it will be noted that the sheath 24 'may be subdivided into as many subparts as is envisaged for successive deployment sequences, each of these sub-parts being intended to control the deployment of one or more clamping elements between the retracted configuration, the deployed configuration and the folded configuration, and which can be successively controlled from the proximal portion 8b of the applicator 8.

In the folded configuration of the deployment mechanism 2 ', the support

23 'and the outer plate 22' extend substantially parallel to the longitudinal axis.

FIG. 8a also shows the path of a connecting wire 33 'inside the support body 1'. This wire 33 'has a first end 331' adapted to be connected to a not shown traction device and integrated into the applicator 8 '. The wire 3'3 passes through the proximal portion 1a 'of the support body 1' within a space provided for this purpose and extends essentially along the hollow rod 70 '. This wire 33 'then opens at a free space e' provided in the support body 1 'and located under the inner plate 1 1' received in its housing 1031 '. The connecting wire 33 'then passes through the inner plate 1 1' passing through a hole 1 10 'through, and bifurcates again along the outer surface of the wafer 1 1'; it then passes through the notch 1032 'and is fixed by its second end 332' on an anchoring element 32 'releasably supported by a flexible needle 31'.

Referring now to Figure 8b, the sheath 24 'having been moved along the arrow F1', on an axial stroke C1 ', by appropriate control has caused the pivoting of the support member 23', by cooperation of the teeth carried by it and the rack carried by the sleeve, to reach an expanded configuration of the outer plate 22 'in which it extends substantially perpendicular to the longitudinal axis X, facing a portion of the annular surface S of the wall P visible in FIG.

Advantageously, in this deployed position, at least one hooking tooth or hook 223 'provided on the outer plate 22' hooks a portion of the annular surface S of the wall P visible in FIG. 7.

Turning to FIG. 8c, the sheath 24 'having been further moved along the arrow F2' over an axial stroke C2 ', by appropriate control, caused the pivoting of the support member 23', by cooperation of the fitted teeth. by it and the rack carried by the sleeve, to reach a folded configuration of the outer plate 22 'in which it is folded towards the longitudinal axis X on the side of the distal end of the body of support. The tooth 223 'having hanging the wall P, the outer plate 22 drives a portion of the annular surface S of the wall P in its folding movement and deforms so as to press on the support body, and more precisely on the inner plate 1 1 ' .

Thus, in this second embodiment, the biasing means arranged to tighten and juxtapose the outer plates 22 'on the support body 1', and more precisely on the inner plates 1 1 'supported by the support body 1', in order to progressively deform the annular surface S of the wall P centered around the orifice O so as, on the one hand, to shape on the organic wall P a tubular portion T extending along the longitudinal axis X, and, on the other hand, forming an anchor flange consisting of said outer plates 22 ', comprise the deployment mechanism 2'.

Figure 8d illustrates a subsequent step of operation of the preparation system SP 'according to the second embodiment of the invention. During this step, it is sought to maintain or lock the outer plate 22 'and the inner plate 1 1' enclosing the wall P in the configuration shown in Figure 8c by means of a connecting wire 33 connecting said inner plates and external 1 1 ', 22'.

For this purpose, the traversing and anchoring mechanism 3 'is actuated so as to pass the second end 332' of its retracted configuration in which it is situated at a radial distance d1 'from the longitudinal axis X, visible through example in Figure 8c, its anchored configuration in which it is retained on the outer plate 22 after passing through the wall P.

This actuation is here carried out by moving the rod 106 'according to the arrow F3' on a stroke C3 '. This displacement of the rod 106 'drives the flexible needle 31' in axial translation via the heel 1061 '. Coming into contact with the ramp 360 'provided on the element 36', the flexible needle 31 'bends outwardly in the radial direction, passes through a through slot 1033' formed in the support body 1 and obliquely crosses the tubular portion T formed on the wall P, as well as the anchoring portion 220 'provided on the outer plate 22.

The stroke C3 'of displacement of the rod 106' will be appropriately sized so that the second end 332 'of the connecting wire 33' and the anchor cylinder 32 'which supports it passes right through the wall P, and than the outer plate 22 'passing through its anchoring portion 220'.

For this purpose, in the exemplary embodiment illustrated, the needle 31 'has on its proximal end a tip 310' adapted to perforate the wall P. By releasing the rod 106 ', we go to the configuration illustrated in Figure 8e, in which the traversing device and anchor 2' returns in its retracted configuration; the distal end of the needle 31 'being no longer subjected to a force transmitted by the heel 1061' of the rod, said needle 31 'naturally returns by springback in its rest position in which it is rectilinear and s' extends substantially parallel to the longitudinal axis X. In doing so, it bears on the ramp 360 'and slides on it by transmitting this return movement to the rod 106' via its distal end integral with the heel 1061 .

Moreover, during this return movement, the needle 31 'drops the anchoring cylinder 32' on which is fixed the second end 332 'of the connecting wire 33', the cylinder 32 'coming to anchor in the anchoring portion 220 'of the outer wafer 22'.

At this stage, and as illustrated in FIG. 8f, a traction force is exerted along the arrow F5 'on the first end 331' of the connecting wire 33 'by means of the traction device arranged in the applicator 8'.

The traction exerted on this first end 331 'is transmitted by the wire 33' to the second end 332 'anchored in the outer plate 22' and causes the tightening of the outer plate 22 'on the inner plate 1 1', by clamping between they wall P

Advantageously, a non-return device is provided between the connecting wire 33 'and the inner plate 1 1', this device for preventing loosening of the outer plate 22 'on the inner plate 1 1' when stopping pulling on the first end 331 'of the connecting wire 33'. For this purpose, the connecting wire 33 'may for example have a beaded portion cooperating with the through hole 1 10' provided on the inner plate 1 1 'to pass the connecting wire 33' to prevent the portion of 33 'wire connecting the outer plate 22' to the inner plate 1 1 'to relax.

Subsequently or simultaneously, the sleeve 24 'is displaced in the distal direction along the arrow F6' so as to cause the pivoting of the support member 23 to a folded position towards the longitudinal axis X, the proximal side of the support body 1 '. This pivoting causes the release of the releasable attachment of the outer plate 22 'on the support member 23', the upper branches 232 'of the fork formed by said support member 23' coming out of the complementary cavity 222 'provided on the outer plate 22 '.

The applicator 8 is then disconnected from the support body 1 and can be extracted outside the body of the patient by passing through the TR trocar. Thus, in this second embodiment, the biasing means arranged to tighten and juxtapose the outer plates 22 'on the support body 1', and more precisely on the inner plates 1 1 'supported by the support body 1', in order to progressively deform the annular surface S of the wall P centered around the orifice O so as, on the one hand, to shape on the organic wall P a tubular portion T extending along the longitudinal axis X, and, on the other hand, forming an anchoring flange consisting of said outer plates 22 ', comprise the connecting son 33' associated with a traction device of these son 33 ', in addition to the deployment mechanism 2'.

At this stage, it would be possible to actuate the ejection device 5 'of the inner plates 1 1' outside the support body 1 ', as well as the cutting device 6' of the connecting wires 33 'in order to be able to extract the support body 1 'outside the body of the patient, leaving inside the latter only the inner and outer plates 1 1', 2'2 each connected by a connecting wire 33 'whose second end 332' is secured an anchoring cylinder 32 ', all of these elements being preferably made of a bio-resorbable material.

The tubular portion T formed on the wall could then be held in shape by mutual contact of the inner plates 1 '' is kept between them in a circular configuration, or by means of a holding element, for example in the form of a notched telescopic ring, holding the inner plates 1 'and / or outer 22' in a circular configuration, and put in place after removal of the support body 1 '.

One could then imagine that one can use the anchoring flange formed by the outer plates 22 'to reconnect on the tubular portion T formed a hollow conduit, organic or not, for example by a manual intervention of the surgeon.

Nevertheless, in the context of the present detailed description, the first tubularization phase of operation is followed by a second anastomosis operative phase for end-to-end reconnection of the patient's urethra to the tubular portion T formed at the level of the orifice made in the wall P of the bladder, by means of the anastomosis system 1 that the invention proposes.

In this second phase of operation, the applicator 8, 8 'having been disconnected from the support body 1, 1' and extracted outside the body of the patient, the surgeon uses the probe 9, identical in the two embodiments described above. Moreover, the elements implemented as part of this second operative phase, or anastomosis phase, are substantially identical in one or other of the embodiments described.

Thus, this phase of anastomosis or reconnection will be described in relation to FIGS. 9, 10a to 10b, 11 and 12, which implements the preparation system SP according to the first embodiment, but would apply from the same way with the preparation system SP 'according to the second embodiment described.

Thus, with reference to FIG. 9, after disconnection and release of the applicator, the surgeon uses probe 9; this probe 9 is introduced into the urethra C from the meatus of the latter, to an opposite end E visible in Figure 9. It is understood that this end E results from an anterior resection of the urethra in its membrane zone , performed especially in the context of a prostatectomy.

As illustrated in this figure 9, the urethral probe 9 is inserted inside the urethra so that its distal end 9a is at the end E of the urethra C. To facilitate this implementation Instead, the distal end 9a of the probe is advantageously provided with a domed cap which, once the probe is positioned, is released by the surgeon by an ad hoc additional tool.

The surgeon then brings the tubular portion T formed on the wall P of the bladder and the end E of the urethra C. closer together. In practice, and in particular so as not to damage the sphincter of the urethra. C, it is preferentially the wall P of the bladder V which is urged to bring its tubular portion T of the end E of the urethra C. For this purpose, the surgeon will be able to pull on the support body 1 or on the outer plates 24 along the arrow F illustrated in Figure 9 to bring the two organs to be anastomosed so that the mucosa of their respective bank are facing in the axial direction.

The surgeon then connects the distal end 9a of the probe 9 to the proximal portion of the support body 1, unrepresented connection and control means engaging with the proximal end 702 of the hollow rod 70, the end 5012 of the stepped element 50 and the proximal end 402 of the support sleeve 40 of the flexible needles 41.

The distal portion 9a of the probe 9 and the proximal portion 1a of the support body 1 advantageously have indexing means for fixing said support body 1 to the end of the probe 9 so that the flexible needles 41, supported by the support body 1, are aligned angularly in the circumferential direction with the through slots 95 provided on the distal portion 9a of the probe 9. Actuation of the suture device 4, employing a plurality of suture elements 44, will now be described with reference to Figs. 9 and 10a to 10c.

In FIG. 9, the suture device 4 is in the retracted configuration of the second ends 442 of the suture elements 44, which is here in the form of threads, preferably made of a bio-resorbable material.

In this retracted configuration, the flexible needles 41 releasably supporting hollow cylinders 42 on which are fixed the second ends 442 of the suture threads 44, are housed inside the longitudinal channels 504 provided in the step element 50 and visible in particular in Figure 4. The second ends 442 of the suture son 44 are then at a radial distance d2 (visible in Figure 10c) lower than the inner radius r2 of the urethra C.

In FIGS. 10a to 10c again, only one elementary module has been shown. It will be understood that the description made in connection with this elementary module, apply to the other five, regularly distributed in the circumferential direction.

Thus, in FIG. 10a, the suture device 4 is illustrated after the flexible needle 41 has been displaced along the arrow F6 by acting on the proximal end 402 of the support sleeve 40.

During this axial displacement, the distal end of the needle 41 is in contact with the ramp 505 provided on the stepped element 50, at the distal end of the channel 504 in which it was completely housed in the initial configuration, this ramp belonging to the stepped element 50 initially fixed in a fixed manner in the axial direction, for example by means of the probe, in a first axial position

The flexible needle 41 then bent outward in the radial direction so as to pass through a through slot 1051 formed in the proximal portion 105 of the fixed portion 101 of the support body 1 and then through a through slot 95 formed in the distal portion 9a of the probe 9 and obliquely crossed the end E of the urethra C.

The axial displacement stroke of the sleeve 40 will be appropriately sized so that the second end 442 of the suture 44 and the anchor cylinder 42 which supports it pass right through the end E of the urethra C.

For this purpose, in the illustrated embodiment, the needle 41 presents on its proximal end a tip 410 adapted to perforate the wall P.

In the position illustrated in FIG. 10a, the suture device 4 is in an expanded intermediate configuration, in which the second end 442 of the suture 44 is opposite an anchoring portion 224, visible for example on Figure 9, provided on the associated outer plate 22.

In this figure 10a, one can also observe the path of the suture 44. This wire 44 has a first end 441 connected to the rear in the distal direction of an orifice 721 provided on the winding mandrel 72. The wire 44 then extends in the distal direction and passes successively through the orifice 721, an orifice 71 1 formed on the annular ring 71 integral with the support body 1, passes through the inner plate 1 1 via a passage 120 provided for this purpose in this one. The wire 44 then extends to the flexible needle 41 and runs along it until it reaches the level of the anchoring cylinder 42, on which its second end 442 is fixed.

In retracted configuration of the suture device, the needle 41 being housed inside its associated channel 504, the wire 44 opens out of the passage 120 on the distal side of the inner plate 1 1, runs inside the through slot 507 formed in the corner 500 and opens inside the channel 504 at the ramp 505.

Referring now to FIG. 10b, the stepped element 50, to which the ramp 505 belongs, has been moved along the arrow F7 by acting on its proximal end 5012 connected to the probe 9, to reach a second axial position.

The flexible needle 41 is no longer in contact with the ramp 505, folds by springback in the direction of the longitudinal axis; in doing so, the needle 41 slightly deforms the end E of the urethra C and further anchors the anchoring cylinder 42 supporting the second end 442 of the suture within the complementary anchoring portion 224 provided on the outer plate 22.

At this point, the needle 41 is moved along the arrow F8 shown in Figure 10c to return to its original configuration within its associated channel 504, having dropped the anchor cylinder 42 carrying the second end of the wire suture 44 inside the anchoring portion 224 provided at the outer plate 22.

Concomitantly or subsequently, the winding mandrel 72 is rotated via the hollow rod 70 connected at its proximal end 702 to the probe 9. This mandrel 72 then drives the first end 441 of the suture 44 and the latter is wound on the body of the mandrel 72. In doing so, the end-to-end anastomosis is tightened between the tubular portion T of the wall P of the bladder V and the end E of the urethra C. Advantageously, the winding mandrel 72 will be associated with a torque limiting system, arranged in the probe 9 controlling in rotation the hollow rod 70 secured to the mandrel 72, or directly by a torque limiting device, for example a sliding / calibrated friction arranged between said rod 70 and said mandrel 72. Thus, it will be possible to accurately and reproducibly adjust the tightening level of the anastomosis thus produced.

Advantageously, a non-return device is provided between the suture 44 and the inner plate 1 1, this device making it possible to prevent the loosening of the wire 44 and the anastomosis performed when the first end is stopped. 441 of the suture 44. For this purpose, the suture 44 may for example have a pearled portion cooperating with the passage 120 provided on the inner plate 1 1 to pass the suture 44 to prevent the portion of wire 44 connecting the outer plate 22 to the inner plate 1 1 via the urethra C to relax.

The anastomosis between the urethra C and the bladder V of the patient having been made and tightened, Figure 1 1 illustrates a step of ejecting the inner plate 1 1 and cutting the connecting son 33 and suture 44.

To do this, the stepped element 50 is moved axially along the arrow F9 in Figure 1 1, until the ejection face 509 of the wedge 500 comes into contact with the inner plate 1 January. The ejection face 509, having a slope, then moves the inner plate 1 1 in the radial direction so as to get it out of its housing 1031 provided in the support body 1. During this radial displacement, the inner plate 1 1 slightly compresses the wall P of the bladder at the tubular portion T as clearly visible in Figure 1 1.

Continuing its advance movement according to the arrow F9, the wedge 500 engages via its cutting blade 506 with the suture 44 and with the binding wire 33 and then jams them and cuts them against a radial face, belonging by example to the annular ring 71 secured to the support body 1.

The inner plate 1 1 having been ejected from the support body and the connecting son 33 and suture 44 having been cut behind the inner plate 1 1, the support body 1 can be released from the intervention zone and the patient's body by means of the probe.

Thus, if we consider again all six elementary modules, the elements left in place inside the body of the patient are then limited to six inner plates 1 1, six outer plates 22, six son 33 each having at their end an anchoring cylinder 32 and six sutures 44 having each at their end an anchoring cylinder 42, all of these elements being preferably made of a bio-resorbable material.

Finally, the operation of the system for producing the anastomosis between the wall P of the bladder and the urethra C according to the second subject of the present invention, taking into account the case where a tubular portion is formed on the organic wall by another bias that by means of the preparation system mentioned above, overcomes a number of steps described in the context of the first object of the present invention.

In particular, the steps related to the deployment and placement of the external clamping elements 22, 22 'on the wall P to form the tubular portion T do not apply to this second object.

Conversely, the description made in particular with reference to FIGS. 8d to 8f, 9, 10a to 10c, 11 and 12, and detailing the various phases of crossing and anchoring of the connection and suture threads 33 ', 44 ', as well as the clamping phases of these wires and the ejection phases of the inner plates 1 1' and cutting the son 33 ', 44' apply to the system according to this second object.

Different options can be considered to define on the wall P a tubular portion, implementing one or more external clamping elements 22 '. For example, it would be possible to provide only an external clamping element in the form of an elastically deformable ring having a plurality of anchoring portions regularly distributed in the circumferential direction intended to receive the anchoring elements of the connecting wires. and suture, and set up by threading it around the clad wall P, for example manually on a cylindrical portion of the support body. In this way, this ring serves as an anchoring flange for the binding and suture threads.

Claims

1. System (SP, SP ') for preparing an orifice (O) arranged on an organic wall (P), characterized in that it comprises:

a support body (1, 1 ') defining a longitudinal axis (X) and having a proximal portion (1 a, 1 a') and a distal portion (1 b, 1 b '), said distal portion (1 b , 1b ') being adapted to be introduced through the orifice (O);

- external clamping elements (22, 22 ') deployable in corolla with respect to the support body (1, 1') being distributed in the circumferential direction, and capable of covering, around said orifice (O), portions of an annular surface (S) of said organic wall (P), and;

- biasing means arranged to tighten and juxtapose said outer clamping elements (22, 22 ') on said support body (1, 1') in order to progressively deform said annular surface (S) to, on the one hand, shape on said organic wall (P) a tubular portion (T) extending along the longitudinal axis (X) and, on the other hand, forming an anchor flange consisting of said outer clamping members (22, 22 ').

2. System according to claim 1, wherein the biasing means comprise connecting elements (33, 33 '), each connecting element (33, 33') being adapted to connect an outer clamping element (22, 22 '). ) to the support body (1, 1 '), and a traction device of the connecting elements (33, 33'), said connecting elements (33, 33 ') each having a first end (331, 331') connected said traction device and a second end (332, 332 ') adapted to be retained on an associated external clamping member (22, 22'), and said pulling device being operable to tighten and juxtapose said external clamping elements ( 22

22 ') on said support body (1, 1').

3. System according to claim 2, further comprising a traversing and anchoring device (3, 3 ') adapted to move the second end (332, 332') of each connecting element (33, 33 ') between a retracted configuration in which said second end (332, 332 ') is at a radial distance (d1, d1') from the longitudinal axis (X) less than the radius (r1) of the orifice (O) and an anchored configuration wherein said second end (332, 332 ') is retained on an associated external clamping member (22, 22') after passing through the wall (P).

The system of any one of claims 1 to 3, further comprising a deployment mechanism (2, 2 ') adapted to move said elements of external clamping (22, 22 ') at least between a retracted configuration in which they are folded towards the longitudinal axis (X), and an extended configuration in which they are spaced apart with respect to the longitudinal axis (X) and extend corolla substantially perpendicular thereto;

and wherein the deployment mechanism (2, 2 ') comprises support members (23, 23') on which the outer clamping members (22, 22 ') are releasably supported.

The system of claim 4, wherein the deployment mechanism (2 ') is further adapted to move the outer clamping members (22') between the deployed configuration and a folded configuration in which said outer clamping members (22 '). ') are folded towards the longitudinal axis (X) on the side of the distal end of the support body (1');

and wherein said deployment mechanism (2 ') belongs to the biasing means.

6. System according to claim 5, wherein the traversing and anchoring device (3 ') is adapted to move the second end (332') of each connecting element (33 ') between the retracted configuration and the anchored configuration. when the outer clamping elements (22 ') are in the folded position.

7. System according to claims 3 and 4, wherein the traversing and anchoring device (3) is adapted to move the second end (332) of each connecting element (33) between the retracted configuration and the anchored configuration when the outer clamping elements (22) are in the deployed configuration.

8. System according to any one of claims 1 to 7, wherein the support body (1, 1 ') releasably supports internal clamping elements (1 1, 1 1') aligned angularly in the circumferential direction with the external clamping elements (22, 22 '),

and wherein the biasing means is arranged to constrict and juxtapose said outer clamping members (22, 22 ') on said inner clamping members (11, 11').

9. System according to claim 8, further comprising an ejection device (5) adapted to move the inner clamping elements (1 1, 1 1 ') between a retracted configuration in which they are at least partially housed at the inside of the support body (1, 1 '), and an ejected configuration in which they are extracted outside said support body (1, 1').

System according to claim 2 and any one of claims 8 and 9, wherein each connecting element (33, 33 ') comprises a portion associated with a respective internal clamping element (1 1, 1 1'), the system further comprising a cutting device (6) adapted to sever the connecting elements (33, 33 ') between the inner clamping elements (1 1, 1 1') and the first ends (331, 331 ') of said connecting elements (33, 33 ').

1 1. System (SA) for making an anastomosis between an organic wall (P) having an orifice (O) and a hollow organic conduit (C), said system comprising:

a system (SP, SP ') according to any of claims 8 to 10, and

a device for connecting said duct (C) and the tubular portion (T) formed on the wall (P), said device being arranged at least partly in a proximal portion of the support body (1, 1 ') adapted to be introduced inside the conduit (C) and comprising:

suture elements (44) adapted to connect the inner and outer clamping elements (1 1, 1 1 ', 22, 22') and each having a first end (441) connected to a clamping device (7, 7); ') and a second end (442) adapted to be retained on an associated external clamping member (22, 22'), and;

a suture device (4) adapted to move the second end

(442) of each suture member (44) between a retracted configuration in which said second end (442) is at a radial distance (d2) from the longitudinal axis (X) less than the inside radius (r2) of said duct ( C), and an anchored configuration in which said second end (442) is retained on an associated external clamping member (22, 22 ') after passing through the conduit (C) from the inside to the outside.

The system of claim 11, wherein each suture member (44) comprises a portion associated with a respective internal clamping member (11, 11 '), the system further comprising a cutter (6). adapted to sever the suture members (44) between the inner clamping members (1 1, 1 1 ') and the first ends (441) of said suture members (44).

13. Method for preparing an orifice (O) arranged on an organic wall (P), the method according to which:

- There is a support body (1, 1 ') defining a longitudinal axis (X) and having a proximal portion (1a, 1a') and a distal portion (1b, 1b '); external clamping elements (22, 22 ') are also available;

the distal portion (1b, 1b ') of the support body (1, 1') is introduced through the orifice (O);

the outer clamping elements (22, 22 ') are deployed in a corolla with respect to the support body (1, 1'), said external clamping elements (22, 22 ') being distributed in the circumferential direction, and covering, around said orifice (O), portions of an annular surface (S) of said organic wall (P);

the external clamping elements (22, 22 ') are urged to tighten and juxtapose said external clamping elements (22, 22') on said support body (1, 1 ') so as to progressively deform said annular surface (S ) for, on the one hand, forming on said organic wall (P) a tubular portion (T) extending along the longitudinal axis (X) and, on the other hand, forming an anchoring flange consisting of the elements of external clamping (22, 22 ').

A method for preparing an orifice (O) provided on an organic wall (P) according to claim 13, wherein the support body (1, 1 ') releasably supports internal clamping elements (1 1, 1 1 ') aligned angularly in the circumferential direction with the outer clamping elements (22, 22'), the outer clamping elements (22, 22 ') are urged to tighten and juxtapose said outer clamping elements (22, 22') on said inner clamping elements (11, 11 ').

15. Method for producing an anastomosis between an organic wall (P) having an orifice (O) and a hollow organic conduit (C), the method according to which:

the orifice (O) arranged on the wall (P) is prepared according to the method according to claim 14;

at least part of the proximal portion (1 a, 1 a ') of the support body (1, 1') is introduced into the conduit (C);

- suture elements (44) are provided which are suitable for connecting the inner and outer clamping elements (1 1, 1 1 ', 22, 22') and each having a first end (441) connected to a clamping device ( 7, 7 ') and a second end (442) adapted to be retained on an associated external clamping member (22, 22'), and;

the second end of each suture element (44) is moved between a retracted configuration in which said second end (442) is at a radial distance (d2) from the longitudinal axis (X) which is smaller than the inside radius (r2) said conduit (C), and an anchored configuration wherein said second end (442) is retained on an associated external clamping element (22, 22 ') after passing through the conduit (C) from the inside to the outside.

The method of performing an anastomosis according to claim 15, wherein, each suture member (44) comprising a portion associated with a respective internal clamping member (11, 11 '), the suture elements are cut (44). ) between the inner clamping elements (1 1, 1 1 ') and the first ends (441) of said suture elements (44).