Patent Application
20150080920
This application claims priority under 35 USC §119 and the Paris Convention to French Patent Application No. FR 12 00731, filed on Mar. 9, 2012.
The present invention relates to the field of surgery, and in particular to the fields of urological, visceral, vascular, and other surgeries.
More particularly, the invention relates to a surgical treatment system for performing an anastomosis between an organic wall having an opening and an organic hollow tube, such as the bladder and urethra of a patient. The invention may, for example, be used following a prostatectomy undergone by the patient, typically a radical prostatectomy or total vesiculo-prostatectomy, with the aim of surgically restoring communication between the bladder and the terminal opening of the urethra at the end opposite the urethral meatus.
Conventionally, anastomosis between the bladder and urethra of a patient is performed manually by surgeons using a needle to place one or more sutures. During such a procedure, the surgeons must first reconstruct the bladder neck. To do so, they deform the bladder wall at the opening created in this wall by the prostatectomy, to form a neck or tubular portion to connect to the urethra by suturing.
Such a treatment method offers certain advantages, including the fact that it creates an end-to-end connection of the urethra and the neck or tubular portion formed on the bladder wall. More specifically, such a method directly joins the edge of the bladder neck and the edge of the terminal end of the urethra, without having to fold either of these edges back. Direct contact is thus established between the mucosa of the respective edges, which is particularly advantageous in terms of healing and a complete and reliable restoration of communication between the patient's bladder and urethra.
However, this manual anastomosis technique has many disadvantages and is particularly difficult to perform. Such a technique requires a particularly long period for the surgery and a high level of dexterity in the surgeon, especially for reconstructing the bladder neck and precisely aligning the ends of the two channels to be connected, which in this case are the terminal opening of the urethra and the neck or tubular portion shaped on the bladder wall. Such a manual reconnection is made even more complex because the procedure area, located behind the pubic bone, is particularly difficult to access and contains the sphincter whose integrity must be preserved throughout the procedure by avoiding any pulling, perforation, squeezing, etc.
Moreover, this manual surgical method can have the disadvantage of being performed as open surgery and requiring large incisions in the body wall in order to access the procedure area, resulting in many inconveniences for the patient, particularly in terms of length of hospitalization, recovery time, and postoperative sequelae.
Finally, because of the manual nature of this surgical technique it is relatively tedious for surgeons, who must pay particular attention to suturing a properly tight anastomosis and establishing a consistently tight connection along the circumference of the anastomosis area. An insufficiently tight connection between the two portions of organic tubes hinders tissue healing, poses a risk of infection, and may ultimately result in separation of the connection between the two portions to be joined. Conversely, an excessively tight connection can cause tissue damage and lead to stenosis in the anastomosis area.
Another known technique is described in document US 2008 114385A and consists of folding the edge of the bladder neck and the edge of the terminal opening of the urethra inwards or outwards, and attaching the folded portions by a series of staples introduced from inside or outside the hollow organs to be treated. However, such a technique is not completely satisfactory because, since the edges of the openings connecting the two bodies have been folded, the connection between these two bodies is not end-to-end and their respective mucosa are not touching. This does not allow a natural consolidation of the anastomosis and requires long term fasteners, thus increasing patient recovery time, in particular bladder function, and can lead to the formation of bladder stones. Furthermore, the folding of organ portions to establish a connection creates a risk of thrombosis or stenosis at the anastomosis when these portions are folded inside the organs to be treated, and a risk of infection when these portions are folded outside the organs to be treated, where their mucosa may be exposed to a bacteria-rich environment. Moreover, one can easily see that this technique requires a significant number of staples covering a large portion of the periphery of the anastomosis area, and made of non-resorbable material to ensure longevity of the anastomosis as the tissues heal.
Finally, for an anastomosis between an organic wall having an opening and a organic hollow tube, such as the bladder and urethra of a patient, in particular after a prostatectomy, a first problem consists of forming a tubular portion on the wall at the opening, and giving this tubular portion a geometry that allows it to fit precisely against the end of the organic tube and allows establishing contact between their respective mucosa. The opening formed in the wall during the prior surgery may not necessarily have a regular geometry, and the wall may vary in thickness along the circumference of the opening: establishing a snug fit between the wall and hollow tube and mating their respective mucosa can be particularly difficult. None of the above techniques offer a satisfactory solution to this problem.
According to a first object, the present invention provides a system for preparing a created opening on an organic wall, particularly in preparation for an anastomosis with a organic hollow tube, in order to form on the wall at the opening, in a reliable and reproducible manner, a tubular portion having a predetermined geometry.
The invention further aims to provide a mechanical system which provides surgeons with the ability to perform procedures in a minimally invasive manner, in particular via the natural passages of the patient, in order to limit operative trauma, and which allows preparing an opening in a wall of an organ or vessel in a reliable and reproducible manner, particularly in preparation for a subsequent anastomosis with a organic hollow tube or a prosthesis such a vascular prosthesis.
For this purpose, a first aspect of the invention relates to a system for preparing a created opening on an organic wall, remarkable in that it comprises:
With these arrangements, one can reliably, accurately, and reproducibly prepare the organ wall to form a tubular portion extending from its opening, said portion having a geometry calibrated for an end-to-end or abutting connection to a hollow tube. For this purpose, the external clamping elements placed on the outside of the tubular portion of the wall in the radial direction advantageously form an anchoring clamp that can be used to reconnect the hollow tube.
The invention has a particularly advantageous application in the field of urology, in particular for reconstructing a patient's bladder wall and forming a tubular portion of predefined geometry on the wall at an opening created for example as a result of a prostatectomy, in preparation for an anastomosis with the patient's urethra.
However, it is conceivable to use the tubular portion formed by means of the system according to the invention to connect an inorganic hollow tube to the organ wall, for example a tube that is part of a prosthesis, particularly a vascular prosthesis.
According to the invention, the supporting body has at least one cylindrical or substantially cylindrical portion, and the biasing elements are used to move the external clamping elements towards the supporting body, said external clamping elements pulling the wall towards the supporting body by bearing on portions of an annular surface extending around the wall opening. The wall is then progressively deformed around its opening until it presses against the cylindrical portion of the supporting body and adopts a substantially tubular shape as it is sandwiched between said supporting body and the external clamping elements.
The external clamping elements may advantageously have at least one gripping and/or attachment hook to establish the gripping and/or attachment of said external clamping elements to the portions of the annular surface of the wall extending around the opening.
Advantageously, the system comprises an applicator for placing the supporting body through the opening formed in the wall and for fastening said supporting body to said wall. This applicator is adapted for removable connection to the proximal portion of the supporting body and for at least partially controlling the biasing elements, in particular from outside the patient's body.
In an advantageous arrangement of the invention, the biasing elements comprise connecting elements, each connecting element being adapted to connect an external clamping element to the supporting body, and a device for exerting traction on the connecting elements, said connecting elements each having a first end connected to said traction device and a second end adapted to be retained on an associated external clamping element, and actuation of said traction device tightening and juxtaposing said external clamping elements on said supporting body. The connecting elements are used to connect the external clamping elements and the supporting body by passing through the wall. These connecting elements are preferably flexible. They can advantageously be in the form of thread, for example of a bioresorbable material.
The traction device can advantageously be housed inside the supporting body and controlled from the applicator which places and stabilizes the supporting body. Alternatively, the traction device can be carried and controlled by the applicator.
Advantageously, it is possible for the traction device to be provided with a force-limiting system to limit the squeezing of the wall against the supporting body by the external clamping elements. This minimizes the risk of injury to organ tissue due to excessive tightening of the connecting elements.
Preferably, a return prevention device can be provided between the connecting elements and the supporting body, said device being adapted to prevent the external clamping elements from loosening on the supporting body when actuation of the traction device ceases.
According to another advantageous arrangement of the invention, the system further comprises a feedthrough and anchoring device adapted to move the second end of each connecting element between a retracted configuration where said second end is located at a radial distance from the longitudinal axis that is less than the radius of the opening, and an anchored configuration where said second end is retained on an associated external clamping element after passing through the wall. Thus, the second ends of the connecting elements in the retracted configuration can be inserted through the opening, and then moved to the anchored configuration such that they pass through the wall and are anchored in the external clamping elements placed on the other side of the wall.
Preferably, the feedthrough and anchoring device comprises support members for releasably supporting the second ends of the connecting elements.
Advantageously, the second ends of the connecting elements are provided with an anchoring element adapted to engage with a corresponding anchoring portion provided on the external clamping elements in order to retain said second ends on said external clamping elements when they are in the anchored configuration after passing through the wall.
The support members of the feedthrough and anchoring device and/or the anchoring elements equipping the second ends of the connecting elements may advantageously have a tip able to pierce the wall when said second ends move from their retracted configuration to their anchored configuration.
Preferably, in the retracted configuration, the second end of each connecting element is located at a radial distance from the longitudinal axis that is less than or substantially equal to the outer radius of the supporting body.
Advantageously, the feedthrough and anchoring device is integrated into the supporting body, and extends into the distal portion of said body intended for introduction through the wall opening.
Thus, in the retracted configuration, the connecting elements and the feedthrough and anchoring device can be accommodated inside the supporting body, which minimizes the risk of its catching on and damaging the tissue or affecting the function of the system according to the invention when it is inserted into the patient's body.
According to a preferred embodiment of the invention, this feedthrough and anchoring device can be controlled by the applicator, for example by means of a cable or a coupling rod.
According to a particular embodiment of the invention, the system further comprises a deployment mechanism adapted to move said external clamping elements at least between a retracted configuration where they are folded in the direction of the longitudinal axis, and a deployed configuration where they are away from the longitudinal axis and flare outwards substantially perpendicularly to it, and the deployment mechanism comprises support members on which the external clamping elements are releasably supported.
The deployment mechanism is adapted to move the external clamping elements between the deployed configuration and a collapsed configuration either simultaneously or sequentially. In the case of a sequential deployment of the external clamping elements by the deployment mechanism, the external clamping elements can be moved individually, one after the other, in a predetermined sequence, for example one after the other circumferentially or in a more dispersed manner. It is also conceivable to have sequential deployment in subsets of external clamping elements, the external clamping elements that are part of each subset being regularly distributed circumferentially. Thus, in the case of six external clamping elements, it is possible for example to provide two successive deployment sequences, namely a first deployment sequence in which three clamping elements spaced 120° apart circumferentially are deployed, followed by a second deployment sequence in which three clamping elements spaced 120° apart circumferentially and located between the external clamping elements deployed in the first sequence, are deployed. Again in the case of six external clamping elements, three successive deployment sequences could be provided for example, by pairs of diametrically opposed external clamping elements.
It can thus advantageously be arranged so that, when the second ends of the connecting elements and the external clamping elements are in the retracted configuration, one can insert from outside the patient's body, particularly by means of the applicator, the assembly consisting of the supporting body, the deployment mechanism with said external clamping elements, and the biasing elements at least partially housed inside the supporting body, through a through-hole formed in a trocar placed on an external body wall of the patient, for example the abdominal wall.
Advantageously, the deployment mechanism is provided on the end of a distal portion of the applicator, adapted for connection to the supporting body, said mechanism preferably being 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 member adapted to cooperate with the wall to limit the insertion of the supporting body through the opening. Alternatively, the stop member could be provided directly on the supporting body.
In a first embodiment, the feedthrough 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 external clamping elements between the deployed configuration and a collapsed configuration where said external clamping elements are folded in the direction of the longitudinal axis on the distal end side of the supporting body, and said deployment mechanism is part of the biasing elements.
In this embodiment, the external clamping elements in the deployed configuration can be moved to a collapsed configuration by pulling and progressively deforming the wall so that it is pressed against the supporting body and adopts a substantially tubular shape as it is sandwiched between said supporting body and the external clamping elements.
Similarly to the movement between the retracted configuration and the deployed configuration of the external clamping elements, the deployment mechanism is adapted to move the external clamping elements either simultaneously or sequentially between the deployed configuration and the collapsed configuration.
In this second embodiment, the feedthrough 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 collapsed configuration.
According to a particularly advantageous arrangement of the present invention, the supporting body releasably supports internal clamping elements angularly aligned circumferentially with the external clamping elements, and the biasing elements are arranged to tighten and juxtapose said external clamping elements on said internal clamping elements. These internal clamping elements, when they are retained on the supporting body, define a substantially cylindrical portion therewith, which the wall is pressed against via the biasing elements, causing it to adopt a substantially tubular shape. When the internal clamping elements are separated from the supporting body, the wall is sandwiched between the external and internal clamping elements, and the supporting body can be withdrawn from the opening and removed from the patient's body, particularly by means of the applicator.
Advantageously, the system further comprises an ejection device adapted to move the internal clamping elements between a retracted configuration where they are at least partially housed inside the supporting body, and an ejected configuration where they are removed from said supporting body. Preferably, the ejection device is integrated with the supporting body. It may 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 for cutting the connecting elements between the internal clamping elements and the first ends of said connecting elements. Preferably, the cutting device is integrated with the supporting body. It may be controlled by means of the applicator.
The internal clamping elements may advantageously be sized so that, after removal of the supporting body, they are held together in a circular configuration by their mutual contact with each other.
Additionally or alternatively, a retaining element may be provided that is able to retain the internal clamping elements and/or external clamping elements in a circular configuration after removal of the supporting body.
Through these arrangements, the hole created in the wall can be prepared so as to form a tubular portion on the wall which can be connected to an organic or inorganic hollow tube.
Still according to this first aspect, the invention also relates to a method for preparing a created opening on an organic wall, wherein:
According to an advantageous arrangement, in the method for preparing a created opening on an organic wall according to the invention, with the supporting body releasably supporting internal clamping elements angularly aligned circumferentially with the external clamping elements, the external clamping elements are urged so as to tighten and juxtapose said external clamping elements on said internal clamping elements.
Preferably, in the method for preparing a created opening on an organic wall according to the invention, the internal clamping elements are moved between a retracted configuration where they are at least partially housed inside the supporting body, and an ejected configuration where they are withdrawn from said supporting body.
Again preferably, in the method for preparing a created opening on an organic wall according to the invention, with each connecting element comprising a portion associated with an associated internal clamping element, the connecting elements are cut between the internal clamping elements and the first ends of said connecting elements.
Another aim of the invention is to propose a system for performing anastomosis which provides a reliably reproducible and minimally invasive end-to-end connection of a tubular portion, formed by means of the system described above at an opening created in an organic wall, and an organic hollow tube.
Thus, according to a second aspect of the invention, a system is provided for performing an anastomosis between an organic wall having an opening and an organic hollow tube, said system comprising:
With these arrangements, an end-to-end connection is created between the organic hollow tube and the tubular portion formed on the organic wall, so as to establish direct contact between their respective mucosa, which is particularly advantageous in terms of healing and complete and reliable restoration of the communication between the two organs, particularly between the patient's bladder and urethra.
The suture elements connect the external clamping elements and the supporting body by passing through the tube. These suture elements are preferably flexible. They can advantageously be in the form of thread, made for example of a bioresorbable material.
Advantageously, the system further comprises a control probe for the device for connecting the organic hollow tube and the tubular portion formed on the wall. This probe is adapted to be introduced into the hollow tube, and to be removably connected to the proximal portion of the supporting body in order to at least partially control said device, especially from outside the patient's body.
The tightening device can advantageously be housed inside the supporting body and controlled from the control probe. Alternatively, the tightening device can be carried and controlled by the probe.
Advantageously, it can be arranged so that the tightening device is provided with a force-limiting system to limit the clamping force of the anastomosis. This minimizes the risk of injury to body tissues due to excessive tightening of the suture elements which can lead to stenosis in the anastomosis area.
Preferably, a return prevention device can be provided between the suture elements and the internal clamping elements, said device being adapted to prevent the suture elements from loosening when actuation of the tightening device ceases.
In preferred embodiments of the invention, one or more of the following arrangements may be used:
Still according to this second aspect, the invention also relates to a method for performing an anastomosis between an organic wall having an opening and an organic hollow tube, wherein:
In an advantageous arrangement, in the method for performing an anastomosis between an organic wall having an opening and an organic hollow tube according to the invention, each suture element comprising a portion associated with a respective internal clamping element, the suture elements are cut between the internal clamping elements and the first ends of said suture elements.
With these arrangements, the anastomosis performed using the system according to the invention is maintained, after withdrawal of the supporting body, by means of suture elements connecting the internal clamping elements to the external clamping elements by passing through the organic hollow tube from the inside to the outside in the radial direction and straddling the anastomosis area, said internal and external clamping elements being held together on the wall by means of connecting elements passing through the wall, in order to define a tubular portion thereon. In this manner, the respective edges of the organic hollow tube and the tubular portion formed on the organic wall are rendered contiguous, as tubular extensions of one another, forming an interface with direct contact between their respective mucosa.
It is particularly advantageous if the external clamping elements, the internal clamping elements, the connecting elements, and/or the suture elements are made of a bioresorbable material, meaning a material which can be resorbed by the physico-chemical activity of living tissue in contact with the material. For example, the component material of these elements can be a bioresorbable polymer such as polylactic acid (PLA, PLLA), polyglycolic acid (PGA), or polydioxanone (PDO).
Thus, the elements left within the patient's body after preparation of the created opening on the organic wall, using the system according to the first aspect of the invention, or after anastomosis between said wall and the organic hollow tube performed by means of the system according to the second aspect of the invention, will be resorbed through contact with the body tissue and the surrounding fluids, and it will not be necessary to schedule a subsequent procedure to remove these elements.
Finally, the invention also provides for the case where a tubular portion is formed on the organic wall by a means other than the preparation system described above.
A second object of the invention therefore relates to a system for performing an anastomosis between an organic wall having an opening and an organic hollow tube, said system comprising:
With these arrangements, an end-to-end connection is created between the organic hollow tube and the tubular portion defined on the organic wall, establishing direct contact between their respective mucosa, which is particularly advantageous in terms of healing and the complete and reliable restoration of communication between the two organs, particularly between the patient's bladder and urethra.
The suture element connects the external clamping element and the supporting body by passing through the tube. This suture element is preferably flexible. It may advantageously be in the form of thread, made for example of a bioresorbable material.
In preferred embodiments of the invention, one or more of the following arrangements may be used:
Advantageously, this system may comprise a single control element adapted for controlling the various devices during a single operative phase of anastomosis. This control element consolidates, for example, all control functions of the applicator and probe which are carried out as part of the first object of the invention.
Still according to this second object, the invention also relates to a method for performing an anastomosis between an organic wall having an opening and an organic hollow tube, wherein:
Other features and advantages of the invention will be apparent from the following description of one of its embodiments, given by way of non-limiting example, with reference to the accompanying drawings.
In the drawings:
a to 5f are longitudinal half section views along line VV of
a-8f are longitudinal half section views along line VIII-VIII of
a to 10c are longitudinal half section views along line IX-IX of
In the different figures, the same references denote identical or similar elements.
In the following description, it is assumed that this wall P is part of a bladder V and that the opening O in it was created during a prostatectomy. Furthermore, the organic hollow tube C considered in the context of the present description is the patient's urethra, of which the open end E, resulting from a prior resection of the urethra in its membranal area that was performed during the prostatectomy, needs to be reconnected to the wall P of the bladder V during an anastomosis operation in order to restore communication between the bladder and the terminal opening of the urethra opposite the urethral meatus, which is open at this end E.
A first aim of the invention is to propose a system SP, SP′ for preparing the wall P of the bladder V so as to form this tubular portion T at the opening O.
A second aim of the invention is to propose an anastomosis system SA for establishing the end-to-end connection of the tubular portion T, formed by means of said system SP, SP′ at the opening O created on the wall P of the bladder V, and the patient's urethra.
In
The anastomosis system SA further comprises a probe 9 having a proximal control portion 9b for manipulation by the surgeon, a distal portion 9a to which the proximal portion 1a of the supporting body 1 is intended to be connected during a second operating phase or anastomosis phase, and a central elongate portion 9c.
In the embodiment illustrated in
As can also be seen in
In a manner not detailed in the figures, in either of the illustrated embodiments of the preparation system SP, the distal portions 8a, 9 of the applicator 8 and probe 9 are shaped for assembly in a complementary manner to the proximal end of the supporting body 1, 1′, for the purposes of controlling the various devices provided on or within said supporting body 1, 1′. Various embodiments are possible for this, as long as the applicator 8 and probe 9 are able to transmit the control movements of these devices from their proximal portion 8b, 9b visible in
Alternatively, it could be arranged so that the proximal portion of the applicator 8 and/or probe 9 is mechanically connected to an interface linked to a robotic arm, to allow control of the system(s) by a computer under surgeon supervision, particularly in a context of computer-assisted surgery performed remotely.
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 in order to improve clarity; these elements, which are in the form of threads made of bioresorbable materials, are particularly visible in
As can be seen in
The first part, which will be considered here as the fixed part, is in the form of a generally cylindrical member 101 extending along the longitudinal axis X and comprising two hollow cylindrical portions of different outside diameters: a proximal portion 105 having an outside diameter corresponding substantially to the inside diameter of the housings 8d, 9d provided in the distal portions 8a, 9a of the applicator 8 and probe 9, and a distal portion 103 having an outside diameter greater than that of the proximal portion 105.
The proximal portion 105 is axially open at its proximal end and has a plurality of radial slots 1051 along its periphery, here six in number, which connect its inside space to the outside. In the distal extension of these slots 1051, the proximal portion 105 has grooves 1052 on its outer surface which are not radially open to the inside space of the proximal portion 105 and in which the bottom has a longitudinal channel 1053 which opens axially into a corresponding slot 1051 on the proximal side, and into the inside space of the distal portion 103 on the distal side.
The distal portion 103 is axially open at its distal end and defines an inside space communicating with the inside space of the proximal portion 105. The grooves 1052 arranged in the proximal portion 105 extend axially into a proximal portion 1030 of the distal portion 103 and define a plurality of housings 1031 whose usefulness will be further described below. These grooves 1052 stop axially inside the proximal portion 1030 of the distal portion 103. The housings 1031 have a through-opening in their base that connects the inside space of the distal portion 103 with the outside, providing space e to allow the passage of each associated connecting thread 33 as is particularly visible in
The proximal portion 1030 of the distal portion 103 also has notches 1032 on its outer surface which lie in the axial extension of the housings 1031. The distal portion 103 has an annular groove 1033 and a distal portion 1034. The notches 1032 open axially inside the housing 1031 on the proximal side and inside the channel 1033 on the distal side.
The distal portion 103 also has a plurality of radial slots 1035 along its periphery, aligned circumferentially with slots 1051, radially connecting the inside space of the distal portion 103 with the outside, and opening axially at the distal end of the distal portion 103. The utility of these radial slots 1035 will be described in more detail below.
The proximal portion 1030 of the distal portion 103 has a generally cylindrical outer surface in which are arranged the housings 1031 provided for releasably receiving internal clamping elements 11, here in the form of inner plates made of a bioresorbable material, said plates 11 for example fitting tightly inside said housings 1031.
Still referring to
The cylindrical member 104 has a plurality of radial slots 1042 along its periphery, here six in number, connecting its inside space with the outside and aligned circumferentially with slots 1035 provided on the fixed part 101 of the supporting body 1.
A feedthrough and anchoring device 3 is arranged between the fixed part 101 and movable part 102 of the supporting body 1. This device 3 comprises a plurality of needles 31 of which the proximal end releasably supports anchoring elements 32 in the form of hollow cylinders which for example fit tightly on the distal end of the needle 31 with which it is associated, and to which are attached the second ends 332 of the connecting threads 33, the first end 331 of said threads 33 being connected to a traction device advantageously provided at the applicator. Advantageously, the hollow anchoring cylinders 32 are made of a bioresorbable material.
Each of the needles 31 is supported at a distal portion by a plurality of connecting rods, here a proximal rod 34 and two distal rods 35, hinged so as to define a deformable parallelogram mechanism. For this purpose, the distal rods 35 supporting each needle 31 are hinged on the movable part 102 of the supporting body 1, and on the distal portion of the needle 31 that they support; the proximal rod 34 is hinged on a slider 36 movable in translation along the rod 106 and on the distal portion of the needle 31 that it supports. A resilient element, which here is in the form of a coil spring 37 of frustoconical shape, is arranged so that it is compressed for at least a portion of the axial travel of the slider 36.
The slider 36 also has a plurality of radial through-slots 365 allowing a certain displacement of the proximal rods 34. The radial slots 1042 provided on the cylindrical member 104 of the movable part 102 of the supporting body 1 allow a certain displacement of the distal rods 35.
As can also be seen in
The hollow shaft 70 has a distal end 701 and a proximal end 702 adapted for insertion along the longitudinal axis X through the fixed part 101 of the supporting body 1 so as to project in the proximal direction beyond the proximal end of said fixed part 101, and intended to be connected to the applicator 8 in order to control the shaft 70. The shaft 70 and mandrel 72 are part of a clamping device 7 whose operation will be further described below.
In the example represented, the slider 36 of the feedthrough and anchoring device 3 is mounted to be movable in translation along the longitudinal axis on a distal portion of the hollow shaft 70, and the compression spring 37 presses against a radial face of mandrel 72.
Still in
The proximal portion 501 has a proximal end 5012 adapted for insertion along the longitudinal axis X through the fixed part 101 of the supporting body 1, so as to project proximally beyond the proximal end of said fixed part 101, and intended for connection to the applicator 8 in order to control the tiered member 50.
A plurality of longitudinal channels 504, aligned circumferentially with the radial slots 1035 provided on the fixed part 101 of the supporting body 1, are provided on the outer surface of the proximal and central portions 501, 502. These channels 504 terminate at their distal end in a ramp 505 formed in the distal portion 503 and extending distally outwardly in the radial direction until it opens onto the outer surface of the distal portion 503 of the tiered member 50. The distal portion 503 has a plurality of radial through-slots 507 on its outer surface, aligned circumferentially with the channels 504 and having proximal ends which open axially inside the ramps 505.
Moreover, the distal portion 503 and central portion 502 have a plurality of radial through-slots 508 angularly offset to the channels 504 and defining on the distal portion 503 a plurality of wedges 500 extending as the axial extension of the channels 504. At their distal end, each wedge 500 has an ejection face 509 that is part of an ejection device 5 and is adapted to cooperate with the inner plates 11 in order to eject them from their housings 1031 in the radial direction, as will be further described below.
Furthermore, each of these ejection wedges 500 has two arms separated by a through-slot 507 and joined at their distal end by a cutting blade 506 that is part of an cutting device 6.
When the tiered member 50 is in place inside the fixed part 101 of the supporting body 1, the wedges 500 are inserted into slots 1051 provided in the proximal portion 105 of the fixed part 101 of the supporting body 1 and can move inside them by sliding along the bottom of grooves 1052.
Finally, the supporting body 1 concentrically receives a hollow sleeve 40 movable in translation along the longitudinal axis X relative to the fixed part 101 of the supporting body 1. The sleeve 40 has a proximal end 402 adapted for insertion along the longitudinal axis X through the fixed part 101 of the supporting body 1 so as to project proximally beyond the proximal end of said fixed part 101, and intended for connection to the applicator 8 for the purpose of controlling the displacement of the sleeve along the longitudinal axis.
The sleeve 40 is suitable for slipping onto the proximal portion 501 of the tiered member 50 and supports a plurality of resiliently flexible needles 41 suitable for inserting into the channels 504 of the tiered member 50 and for cooperating with the ramps 505 during operation.
The distal end of each needle releasably supports anchoring elements 42 in the form of hollow cylinders which, for example, fit tightly onto the distal end of the needle 41 with which it is associated, and to which are fixed the second ends 442 of the suture threads 44, the first end 441 of said threads 44 being connected to the tightening device 7, and more precisely at the attachment openings 721 of the mandrel 71.
In the embodiment illustrated in
The sleeve 40, needles 41, and tiered member 50 here are part of a suturing device 4 whose operation will be further described below.
Thus, in the embodiment illustrated in
We will now describe a first operative phase of preparing the opening O created on the bladder wall P, so as to form a substantially tubular portion thereon, making use of the preparation system SP according to the first embodiment of the invention.
For this purpose, as can be seen in
In this
The deployment mechanism 2 is able to move the external clamping elements 22 between a retracted configuration, shown in
The distal portion 8a of the applicator 8, fitted in this manner with the supporting body 1 in the initial configuration, and having external clamping elements 22 in the collapsed configuration, may advantageously be inserted through a trocar TR placed on the abdominal wall of the patient, and control of the various devices can be accomplished by means of the proximal portion 8b of said applicator 8 from outside the patient's body, typically during endoscopic surgery.
The applicator 8 fitted with the supporting body 1 is then manipulated by the surgeon so that the body 1 approaches the bladder V, until the distal portion 1a of said body is introduced into the opening O formed in the wall P, centering the longitudinal axis X within the opening O and engaging the distal end 1041 first. The bullet-nose shape of this end 1041 facilitates placement.
The external clamping elements 22, here six in number, are in the form of outer plates made of a bioresorbable material and are releasably supported on support members 23, for example by having complementary shapes.
The distal portion 8a of the applicator 8 and the proximal portion 1a of the supporting body 1 advantageously have indexing elements for fixing the supporting body 1 to the end of the applicator 8 so that the outer plates, supported by the applicator 8, are angularly aligned circumferentially with the inner plates 11 supported by the distal portion 1b of the supporting body 1.
Furthermore, the deployment mechanism 2 advantageously has a stop member 20 adapted to cooperate with the wall P to limit the insertion of the supporting body 1 through the opening O.
As can be seen in
a to 5f, as well as 10a to 10f, 11 and 12, illustrate just one of these modules. The reader will understand that what is visible in these figures applies to each of the other five modules.
Thus,
In
In this initial configuration of the preparation system SP, the deployment mechanism 2 is in the configuration with the outer plate 22 collapsed and supported by the support member 23, the feedthrough and anchoring device 3 is in the configuration where the second end 332 of the connecting thread 33 is retracted, this end 332 being at a radial distance d1 from the longitudinal axis X that is less than the radius r1 of the opening O, the inner plate 11 is received within its housing 1031 provided on the supporting body, and the ejection 5 and cutting 6 device, here formed by a wedge 500, is in the inactive configuration.
The suturing device 4 is also in the configuration where the second end 442 of the suture thread is retracted. This device will come into play during the second operative phase, or anastomosis phase, and its operation will be further described below in relation to
Returning to
In a manner not represented in detail in the figures, the stop member 20 is integral to the distal portion 8a of the applicator 8.
In
The lower arm 231 has a plurality of peripheral gear teeth, adapted to cooperate with a rack provided on a distal portion of a sheath 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 sequential deployment of the external clamping elements, the sheath 24 can be divided into as many parts as there are to be successive deployment sequences; each of these parts is intended to control the deployment of one or more clamping elements between the retracted configuration and the deployed configuration, and can be successively controlled from the proximal portion 8b of the applicator 8.
In the collapsed configuration of the deployment mechanism 2, the support 23 and the outer plate 22 extend substantially parallel to the longitudinal axis.
Also visible in
Referring now to
In this deployed position, an anchoring portion 220 formed in the outer plate 22 and designed to retain the anchoring cylinder 32 to which the second end of the connecting thread 33 is fixed, is at a predetermined radial distance d from the longitudinal axis X.
Turning to
By continuing the displacement of the rod 106 as indicated by arrow F3, visible in
This second axial path can be defined in different ways, for example as the stroke required to move the spring 37 from its free state, where it is not subject to any stress, to a compressed state where its turns are touching. In any event, the second axial stroke is dimensioned so that the second end 332 of the connecting thread 33 and the anchoring cylinder 32 which supports it crosses through the wall P and outer plate 22 by passing through the anchoring portion 220. In the embodiment illustrated, the needle 31 has a tip 310 for piercing the wall P, on its proximal end.
By releasing the traction exerted on the rod 106, the relaxation of the spring causes the feedthrough and anchoring device 3 to return to its configuration shown in
Next, by pushing the rod in the direction of arrow F4 visible in
It is now in the configuration shown in
Alternatively, it can be arranged so that the abovementioned two axial paths cause compression of the spring 37; then, by releasing the rod 106 from the configuration in
At this point, and as shown in
The traction exerted on this first end 331 is transmitted by the thread 33 to the second end 332 anchored on the outer plate 22 and initially causes the support member 23 holding the outer plate 22 to pivot towards the longitudinal axis X, on the distal side of the supporting body 1. As it does so, the outer plate 22 begins to deform the wall P by means of its contact with a portion of the annular surface S surrounding the opening O.
By continuing to exert traction on the first end 331 of the connecting thread 33, this causes the release of the releasable attachment of the outer plate 22 to the support member 23, the upper arms 232 of the support member 23, originally housed in the complementary cavity 222 of the outer plate 22 for example by fitting tightly therein, then exiting said cavity 222.
By pulling even further on the first end 331 of the connecting thread 33, the outer plate 22 deforms the wall P by pressing against the inner plate 11 housed in the supporting body 1; the wall P is then sandwiched between said inner plate 11 and said outer plate 22.
Advantageously, a return prevention device is provided between the connecting thread 33 and the inner plate 11, to prevent the outer plate 22 from relaxing its pressure against the inner plate 11 when the first end 331 of the connecting thread 33 is no longer being pulled. For this purpose, the connecting thread 33 may for example have a beaded portion cooperating with the through-hole 110 provided on the inner plate 11 for the passage of the connecting thread 33, in order to prevent slackening of the portion of thread 33 connecting the outer plate 22 to the inner plate 11.
Subsequently or simultaneously, the deployment mechanism 2, having released the outer plate 22, is returned to its retracted configuration shown in
The applicator 8 is then disconnected from the supporting body 1 and can be removed from the patient's body through the trocar TR.
In
Thus, in this embodiment, the biasing elements which tighten and juxtapose the outer plates 22 on the supporting body, and more specifically on the inner plates 11 supported by the supporting body 1, in order to gradually deform the annular surface S of the wall P centered around the opening O so as to, on the one hand, shape on the organic wall P a tubular portion P extending along the longitudinal axis X, and on the other hand, form an anchoring clamp composed of said outer plates 22, comprise the connecting threads 33 associated with a device for exerting traction on these threads 33.
At this stage one could actuate the ejection device 5 to eject the inner plates 11 from the supporting body, as well as the cutting device 6 to cut the connecting threads 33 in order to be able to remove the supporting body 1 from the patient's body, only leaving within the patient's body the inner and outer plates 11, 22 each connected by a connecting thread 33 of which the second end 332 is secured to an anchoring cylinder 32, all of these elements preferably being made of a bioresorbable material.
The shape of the tubular portion T formed on the wall can then be maintained by the mutual contact of the inner plates 11 which retain each other in a circular configuration, or by a retaining element, for example in the form of a telescoping notched ring, holding the inner plates 11 and/or outer plates 22 in a circular configuration and put in place after removal of the supporting body 1.
One can then see how the anchoring clamp formed by the outer plates 22 could be used to reconnect the formed tubular portion T to an organic or inorganic hollow tube, for example manually by the surgeon.
However, in the context of the present description, the first operative phase of creating the tubular portion is followed by a second operative phase of anastomosis intended to reestablish an end-to-end connection of the patient's urethra to the tubular portion T formed at the created opening on the bladder wall P, by means of the anastomosis system SA proposed by the invention. The ejection device 5 and cutting device 6 are thus only actuated after this reconnection is established, as will be further described below in relation to
Alternatively, it could be arranged so that the connecting threads 33 are cut by means of an additional ad hoc tool before advancing to the second operative phase of anastomosis.
Prior to this, the invention proposes a second embodiment of a system SP′ for preparing the bladder wall P to form a tubular portion T which extends from its opening O.
This preparation system SP′ according to the second embodiment makes use of an applicator 8′ identical to the applicator 8 of the first embodiment, except for the deployment device 2′ which differs from the one in the first embodiment. Its operation will be detailed in relation to
In this second embodiment, and as can be seen in particular in
The sleeve 40′, needle 41′, and tiered member 50′ that appear in
Similarly, the ejection device 5′ and cutting device 6′ visible in
For these various elements of the second embodiment, the same references will be used as in the first embodiment, but with the addition of the ′ symbol.
For clarity in
Referring to
In this second embodiment, the supporting body 1′ has a distal portion 103′ comprising a proximal portion 1030′ similar to the proximal portion 1030 of the distal portion 103 described for the first embodiment. This proximal portion 1030′ essentially defines housings 1031′ for receiving inner plates 11′ opening radially outwards and communicating with the inside space of the supporting body so as to provide a space e′ for each associated connecting thread 33′ as is particularly visible in
The distal portion 103′ of the supporting body also has a distal portion 1034′ of generally frustoconical shape whose diameter decreases in the distal direction. This frustoconical distal portion 1034′ has a bullet-nose distal end 1036′. The external design of this frustoconical distal portion 1034′ facilitates insertion of the distal portion 103 of the supporting body through the opening O.
This distal portion 103′ also has a plurality of radial through-slots 1033′ that connect the inside space it defines with the outside. The usefulness of these slots 1031′ will be described later.
The supporting body 1′ according to the second embodiment concentrically receives the suturing device 4′, mentioned previously but not described in detail, and a clamping device 7′ and feedthrough and anchoring device 3′.
The feedthrough and anchoring device 3′ is in the form of a rod 106′ extending along the longitudinal axis X and movable in translation along said axis relative to the supporting body 1′. The rod 106′ has a distal shank 1061′ carrying a plurality of resiliently flexible needles 31′ each releasably supporting, on their proximal end, an anchoring element 32′ to which is fixed the second end 332′ of an associated connecting thread 33′. Each anchoring element 32′ is here in the form of a cylinder having a frustoconical proximal end and a housing for receiving the proximal end of the needle 31′ with which it is associated.
The rod 106′ also has a proximal end 1062′ adapted to project proximally beyond the proximal end of the supporting body and intended to be connected to the applicator 8′ for the purposes of controlling the movement of said rod 106′.
The feedthrough and anchoring device 3′ according to this second embodiment further comprises an element 36′ defining a ramp 360′ for the flexible needles 31′; here it is in the form of a rotationally symmetrical element 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′ increases gradually in the proximal direction between its distal end 361′ and its proximal end 362′.
This element 36′ is mounted in an integral manner on a distal end 701′ of a mandrel formed in this second embodiment by a hollow shaft 70′ ending at its distal end in an annular flange 72′ having a plurality of through-holes and attachment holes 721′ for the suture threads 44′ (not represented in
This hollow shaft 70′ is adapted to be threaded onto the rod 106′ and to rotate on said rod about the longitudinal axis. Once in place with the rod 106′ inside the supporting body 1′, the proximal end 702′ of the hollow shaft 70′ protrudes proximally beyond the proximal end of the supporting body 1′, and is intended for connection to the applicator 8′ for the purposes of controlling the shaft 70′.
Finally, again as is visible in
The assembly thus formed comprises the feedthrough and anchoring device 3′, the clamping device 7′, and the suturing device 4′. This assembly is intended for insertion into the supporting body 1′.
Once inserted into the supporting body 1′, the proximal ends 402′, 5012′ of the sleeve 40′ and the tiered member 50′ protrude proximally beyond the proximal end of the supporting body 1′, and are intended to be connected to the applicator 8′ for the purposes of controlling the suturing device 4′.
Thus, in the embodiment illustrated in
We will now describe a first operative phase of preparing the opening O, arranged on the bladder wall P, so as to form a substantially tubular portion at the opening, making use of the preparation system SP′ according the second embodiment of the invention.
For this purpose, as can be seen in
In this
This deployment mechanism 2′ is adapted to move the external clamping elements 22′ between a retracted configuration, shown in
The distal portion 8a′ of the applicator 8′, equipped with the supporting body 1′ in its initial configuration, and having external clamping elements 22′ in the collapsed configuration, may advantageously be inserted through a trocar TR placed on the abdominal wall of the patient, and the various devices may be controlled from outside the patient's body by means of the proximal portion 8b′ of said applicator 8′, typically during endoscopic surgery.
The applicator 8′ fitted with the supporting body 1′ is then manipulated by the surgeon so that the body 1′ approaches the bladder V, until the distal portion 1a′ of said body is inserted into the opening O formed in the wall P, centering the longitudinal axis X within this opening O and engaging the distal end 1036′ first. The bullet-nose shape of the end 1036′ and the frustoconical shape 1034′ provided on the supporting body 1′ facilitate this insertion.
The external clamping elements 22′, here six in number, are in the form of outer plates made of a bioresorbable material and are releasably supported on the support members 23′, for example by having complementary forms.
The distal portion 8a′ of the applicator 8′ and the proximal portion 1a′ of the supporting body 1′ advantageously have indexing elements which allow fixing said supporting body 1′ to the end of the applicator 8 so that the outer plates 22′, supported by the applicator 8′, are angularly aligned circumferentially with the inner plates 11′ supported by the distal portion 1b′ of the supporting body 1′.
As can be seen in
a to 8f illustrate one of these modules. The reader will understand that what is visible in these figures also applies to each of the other five modules.
a to 8f therefore illustrate the various steps in preparing the opening O by means of the preparation system SP′ according to the second embodiment of the invention.
In
In this initial configuration of the preparation system SP′, the deployment mechanism 2′ is in the configuration with the outer plate 22′ collapsed and supported by a support member 23′, the feedthrough and anchoring device 3′ is in the configuration where the second end 332′ of the connecting thread 33′ is retracted, this end 332′ being at a radial distance d1′ from the longitudinal axis X that is less than the radius r1 of the opening O, the inner plate 11′ is received within its housing 1031′ provided on the supporting body 1′, and the ejection 5′ and cutting device 6′, formed here by a wedge 500′, is in the inactive configuration.
The suturing device 4′ is also in the configuration where the second end 442′ of the suture thread is retracted. This device will come into play during the second operative phase, or anastomosis phase, and its operation will be further described below in relation to
Returning to
In a manner not represented in detail in the figures, the positioning element 20′ is integral with the distal portion 8a′ of the applicator 8′.
In
The lower arm 231′ has a plurality of peripheral gear teeth, adapted to cooperate with a rack provided on a distal portion of a sheath 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 sequential deployment of the external clamping elements, the sheath 24′ can be divided into as many subparts as there are to be successive deployment sequences; each of these subparts is intended to control the deployment of one or more clamping elements between the retracted configuration, the deployed configuration, and the collapsed configuration, and can be successively controlled from the proximal portion 8b′ of the applicator 8′.
In the collapsed configuration of the deployment mechanism 2′, the support 23′ and the outer plate 22′ lie substantially parallel to the longitudinal axis.
Also visible in
Referring now to
Advantageously, in this deployed position, at least one catch hook or tooth 223′ provided on the outer plate 22′ catches on a portion of the annular surface S of the wall P visible in
Turning to
Thus, in this second embodiment, the biasing elements arranged to tighten and juxtapose the outer plates 22′ on the supporting body 1′, and more precisely on the inner plates 11′ supported by the supporting body 1′, in order to progressively deform the annular surface S of the wall P centered around the opening O so as to, on the one hand, shape on the organic wall P a tubular portion P extending along the longitudinal axis X, and on the other hand, form an anchoring clamp consisting of said outer plates 22′, comprise the deployment mechanism 2′.
d illustrates a subsequent step in the operation of the preparation system SP′ according to the second embodiment of the invention. During this step, the intent is to maintain or lock in the configuration shown in
For this purpose, the feedthrough and anchoring mechanism 3′ is actuated so that the second end 332′ is moved from its retracted configuration where it is positioned at a radial distance d1′ from the longitudinal axis X, visible for example in
This actuation is achieved by moving the rod 106′ in the direction of arrow F3′ along a path C3′. This displacement of the rod 106′ drives the flexible needle 31′ in axial translation by means of the shank 1061′. As it comes in contact with the ramp 360′ provided on the element 36′, the flexible needle 31′ bends radially outward, passes through a through-slot 1033′ arranged in the supporting body 1′, and obliquely traverses the tubular portion T formed on the wall P, as well as the anchoring portion 220′ provided on the outer plate 22′.
The path C3′ of movement of the rod 106′ will be dimensioned appropriately to allow the second end 332′ of the connecting thread 33′ and the anchoring cylinder 32′ which supports it to pass entirely through the wall P and outer plate 22′ by passing through the anchoring portion 220′.
For this purpose, in the embodiment illustrated, the needle 31′ has a tip 310′ for piercing the wall P, on its proximal end.
When the rod 106′ is released, the configuration illustrated in
During this return movement, the needle 31′ releases the anchoring cylinder 32′ to which the second end 332′ of the connecting thread 33′ is attached, this cylinder 32′ then catching on the anchoring portion 220′ of the outer plate 22′.
At this point, and as shown in
The traction exerted on this first end 331′ is transmitted by the thread 33′ to the second end 332′ anchored on the outer plate 22′ and causes the outer plate 22′ to press more tightly against the inner plate 11′, sandwiching the wall P between them.
Advantageously, a return prevention device is provided between the connecting thread 33′ and the inner plate 11′, to prevent the outer plate 22′ from relaxing its pressure against the inner plate 11′ when the first end 331′ of the connecting thread 33′ is no longer being pulled. For this purpose, the connecting thread 33′ may for example have a beaded portion cooperating with the through-hole 110′ provided on the inner plate 11′ for the passage of the connecting thread 33′, in order to prevent slackening of the portion of thread 33′ connecting the outer plate 22′ to the inner plate 11′.
Subsequently or simultaneously, the sheath 24′ is moved in the distal direction along arrow F6′ so as to cause the support member 23′ to pivot to a retracted position in the direction of the longitudinal axis X, on the proximal side of the supporting body 1′. This pivoting causes the release of the releasable attachment of the outer plate 22′ to the support member 23′, the upper arms 232′ of the fork formed by said support member 23′ exiting the complementary cavity 222′ provided on the outer plate 22.
The applicator 8′ is then disconnected from the supporting body 1′ and can be removed from the patient's body through the trocar TR.
Thus, in this second embodiment, the biasing elements arranged to tighten and juxtapose the outer plates 22′ on the supporting body 1′, and more specifically on the inner plates 11′ supported by the supporting body 1′, in order to gradually deform the annular surface S of the wall P centered around the opening O so as to, on the one hand, shape on the organic wall P a tubular portion T extending along the longitudinal axis X, and on the other hand, form an anchoring clamp composed of said outer plates 22′, comprise the connecting threads 33′ associated with a device for exerting traction on these threads 33′, in addition to the deployment mechanism 2′.
At this stage one could actuate the ejection device 5′ to eject the inner plates 11′ from the supporting body 1′, as well as the cutting device 6′ to cut the connecting threads 33′ in order to be able to remove the supporting body 1′ from the patient's body, only leaving inside the patient's body the inner and outer plates 11′, 22′ each connected by a connecting thread 33′ of which the second end 332′ is secured to an anchoring cylinder 32′, all of these elements preferably being made of a bioresorbable material.
The shape of the tubular portion T formed on the wall can then be maintained by the mutual contact of the inner plates 11′ which retain each other in a circular configuration, or by a retaining element, for example in the form of a telescoping notched ring, holding the inner 11′ and/or outer plates 22′ in a circular configuration and put in place after removal of the supporting body 1′.
One can then see how the anchoring clamp formed by the outer plates 22′ could be used to reconnect the formed tubular portion T to an organic or inorganic hollow tube, for example manually by the surgeon.
However, in the context of the present description, the first operative phase of creating the tubular portion is followed by a second operative phase of anastomosis intended to reestablish an end-to-end connection of the patient's urethra to the tubular portion T formed at the created opening on the bladder wall P, by means of the anastomosis system 1 proposed by the invention.
In this second operative phase, the applicator 8, 8′ has been disconnected from the supporting body 1, 1′ and removed from the patient's body. The surgeon uses the probe 9, which is identical in the two embodiments described above. The elements used during this second operative phase, or anastomosis phase, are substantially identical in either of the embodiments described.
This anastomosis or reconnection phase will therefore be described in relation to
With reference to
As illustrated in
The surgeon then brings together the tubular portion T formed on the bladder wall P and the end E of the urethra C. In practice, and in particular to prevent damage to the sphincter of the urethra C, preferably it is the wall P of the bladder V which is acted upon to bring its tubular portion T toward the end E of the urethra C. To achieve this, the surgeon can pull on the supporting body 1 or on the outer plates 24 as indicated by arrow F in
The surgeon then connects the distal end 9a of the probe 9 to the proximal portion of the supporting body 1, the connecting and control elements (not represented) engaging with the proximal end 702 of the hollow shaft 70, the proximal end 5012 of the tiered member 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 supporting body 1 advantageously have indexing elements which allow attaching said supporting body 1 to the end of the probe 9 such that the flexible needles 41, supported by the supporting body 1, are angularly aligned circumferentially with the through-slots 95 provided on the distal portion 9a of the probe 9.
Actuation of the suturing device 4, bringing into play a plurality of suture elements 44, will now be described with reference to
In
In this retracted configuration, the flexible needles 41, releasably supporting hollow cylinders 42 to which are fixed the second ends 442 of the suture threads 44, are received within longitudinal channels 504 provided in the tiered member 50 and visible in particular in
In
Thus,
During this axial movement, the distal end of the needle 41 comes in contact with the ramp 505 provided on the tiered member 50, at the distal end 504 of the channel in which it was completely housed in the initial configuration, this ramp which is part of the tiered member 50 initially being maintained in a fixed manner in the axial direction, for example by means of the probe, in a first axial position
The flexible needle 41 is then bent radially outward so as to pass through a through-slot 1051 arranged in the proximal portion 105 of the fixed part 101 of the supporting body 1, then through a through-slot 95 arranged in the distal portion 9a of the probe 9, and then passes at an angle through the end E of the urethra C.
The axial travel of the sleeve 40 will be dimensioned appropriately for the second end 442 of the suture thread 44 and the anchoring cylinder 42 that supports it to pass entirely through the end E of the urethra C.
For this purpose, in the embodiment illustrated, the needle 41 has a tip 410 for piercing the wall P, on its proximal end.
In the position illustrated in
In this
In the retracted configuration of the suturing device, the needle 41 is housed within its associated channel 504, and the thread 44 exits the passage 120 on the distal side of the inner plate 11, runs within the through-slot 507 formed in the wedge 500, and emerges into the channel 504 at the ramp 505.
Referring now to
At this point, the needle 41 is moved in the direction of arrow F8 illustrated in
Subsequently or simultaneously, the mandrel 72 is rotatably driven via the hollow shaft 70 connected at its proximal end 702 to the probe 9. This mandrel 72 then pulls on the first end 441 of the suture thread 44 and winds it around the body of the mandrel 72. By doing so, the end-to-end anastomosis between the tubular portion T of the wall P of the bladder V and the end E of the urethra C is pulled tighter.
Advantageously, the mandrel 72 is associated with a torque limiting system, arranged in the probe 9 controlling the rotation of the hollow shaft 70 integral with the mandrel 72, or directly by a torque limiting device, for example a device with calibrated slip/friction arranged between said shaft 70 and said mandrel 72. The tightness of the anastomosis can thus be adjusted in a precise and reproducible manner.
Advantageously, a return prevention device is provided between the suture thread 44 and the inner plate 11, this device preventing slackening of the thread 44 and of the anastomosis when the first end 441 of the suture thread 44 is no longer being pulled. For this purpose, the suture thread 44 may, for example, have a beaded portion cooperating with the passage 120 provided on the inner plate 11 for the passage of the suture thread 44, in order to prevent slackening of the portion of thread 44 connecting the outer plate 22 to the inner plate 11 via the urethra C.
Once the anastomosis between the patient's urethra C and bladder V has been established and tightened,
To do this, the tiered member 50 is moved axially in the direction of arrow F9 in
Continuing its forward movement in the direction of arrow F9, the cutting blade 506 of the wedge 500 engages with the suture thread 44 and connecting thread 33 then catches them and cuts them against a radial face, which is for example part of the annular ring 71 integral with the supporting body 1.
As the inner plate 11 has been ejected from the supporting body and the connecting 33 and suture 44 threads have been cut behind the inner plate 11, the supporting body 1 can be removed from the work area and from the patient's body, through the probe.
Thus, if we consider the set of six basic modules, the elements remaining within the patient's body are limited to six inner plates 11, six outer plates 22, six connecting threads 33 each having an anchoring cylinder 32 at their end, and six suture threads 44 each having an anchoring cylinder 42 at their end, all these elements being preferably made of a bioresorbable material.
Finally, the operation of the system for performing anastomosis between the bladder wall P and the urethra C, according to the second object of the invention and for the case where a tubular portion is formed on the organic wall by a means other than the preparation system mentioned above, avoids a number of steps described for the first object of the invention.
In particular, the steps related to the deployment and placement of external clamping elements 22, 22′ on the wall P in order to form the tubular portion T do not apply to this second object.
Conversely, the description provided in relation to
Different options can be considered for defining a tubular portion on the wall P, making use of one or more external clamping elements 22. One could, for example, provide only one external clamping element in the form of an elastically deformable ring having a plurality of anchoring portions uniformly distributed along its circumference that are intended to accommodate the anchoring elements for the connecting and suture threads, and put in place by slipping it around the flattened wall P, for example manually over a cylindrical portion of the supporting body. When placed in this manner, the ring would serve as an anchoring clamp for the connecting and suture threads.
| Number | Date | Country | Kind |
|---|---|---|---|
| 1200731 | Mar 2012 | FR | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/FR2013/050509 | 3/11/2013 | WO | 00 |
