Accessory for the implantation of a medical device configured to obturate an anatomical duct

Abstract

The invention relates to an accessory for implanting a medical device in a human or animal body, said medical device comprising an occlusion collar (1) adapted to surround and seal an anatomical duct of said human or animal body, a fluid reservoir (2) and a tube (3) connecting the reservoir to the occlusion collar, said accessory comprising: - a plug (100; 100') adapted to seal one end of the tube; and - a collar (200) adapted to surround the tube, the plug (100) and the collar (200) having respective connecting portions (103, 104; 203, 204) adapted to couple so as to fix the collar (200) and the plug (100) together to hermetically seal said end of the tube (3).

Description

technical field

[0001] The invention relates to an accessory for the implantation of a medical device in a human or animal body configured to block an anatomical duct. State of the art

[0002] There are medical devices available to selectively block an anatomical passage, such as the urethra, bladder neck, or stomach.

[0003] To combat urinary incontinence, it is known to implant in a patient a medical device comprising an inflatable occlusive cuff arranged around the urethra or bladder body, a fluid reservoir and a pump allowing fluid to transfer between the cuff and the reservoir in order to selectively inflate or deflate the cuff to ensure a determined compression of the urethra or bladder neck.

[0004] The fluid connection between these different components is ensured by one or more tubes.

[0005] The connection of the tube with the components is made during the surgical implantation procedure.

[0006] Before implantation, the medical device is filled with a biocompatible fluid and the fluid circuit is purged to avoid the presence of air bubbles.

[0007] To maintain a purged fluid circuit and prevent contamination of the tube's interior and the associated medical device components, the tube ends are capped during implantation until the tube is effectively connected to the components. Each cap must be securely fastened to withstand the significant tensile forces exerted during implantation.

[0008] In practice, the plugs are attached to the tube by sutures.

[0009] However, suturing each stopper to the ends of each tube is a surgeon-specific procedure that lengthens the overall surgical time and can lead to complications, such as disconnection of the stopper from the tube. Documents DE9419630U1, US7597117B1, and EP3290683A1 all describe tube stoppers.

[0010] One object of the invention is therefore to facilitate and secure the connection between the cap and the tube. Brief description of the invention

[0011] One aim of the invention is therefore to design an accessory that simplifies surgical intervention.

[0012] To this end, a first object of the invention relates to an accessory for implanting a medical device in a human or animal body, said medical device comprising an occlusive cuff adapted to surround and seal an anatomical duct of said human or animal body, a fluid reservoir and a tube connecting the reservoir to the occlusive cuff, said accessory comprising: a suitable cap to seal one end of the tube, and a suitable collar to encircle the tube, the cap and the collar having respective connection portions adapted to cooperate so as to fix the collar and the cap together so as to hermetically seal said end of the tube.

[0013] Advantageously, this eliminates the need to use a suture to fix the stopper to the end of the tube.

[0014] In some embodiments the connecting portions of the cap and the neck are arranged so as to allow the neck to fit together with the cap.

[0015] In some embodiments, one of the connecting portions of the collar or the stopper has at least one protrusion and the other connecting portion of the collar or the stopper (which does not include said protrusion) has at least one cavity, said at least one protrusion being elastically deformable to allow the engagement of said at least one protrusion in said at least one cavity.

[0016] In some embodiments, the cap further includes an elongated stem so as to form a guide for inserting the tube during implantation.

[0017] An "elongated shape" is defined as a shape whose length is greater than 10 times its transverse dimension (for example, the diameter in the case of a circular section). In some embodiments, the cap includes a nozzle adapted for insertion into one end of the tube.

[0018] In accordance with the invention, the connection portion of the cap includes an annular groove surrounding said nozzle configured to receive an elastically deformable end of the collar so as to pinch the end of the tube.

[0019] In some embodiments, the cap has at least one gripping area for a clamp configured to connect the neck to the cap.

[0020] In some embodiments, said gripping area comprises two parallel flats bordered by a collar.

[0021] In some embodiments, said flat surfaces are traversed by an opening for the passage of a suture.

[0022] In some embodiments, the accessory includes a cap adapted to surround the stopper so as to ensure continuity of the outer surface of the stopper with respect to the gripping area.

[0023] In some embodiments, said cap comprises two interlocking half-shells on either side of the cap.

[0024] In some embodiments, the said half-shells are articulated by a hinge.

[0025] Another item relates to an implantation kit for the implantation of a medical device in a human or animal body, said medical device comprising an occlusive cuff adapted to surround and seal an anatomical duct of said human or animal body, a fluid reservoir and a tube connecting the reservoir to the occlusive cuff.

[0026] The said kit advantageously includes an accessory as described above, and a clamp including a first jaw adapted to receive a portion of the cap opposite the connection portion of said cap and a second jaw adapted to receive a portion of the collar opposite the connection portion of said collar, said jaws being movable between an open position adapted for engaging the collar and the cap with each respective jaw and a closed position adapted for connecting the collar and the cap by their respective connection portions.

[0027] Another object relates to an assembly comprising a medical device and an accessory as described above for the implantation of said medical device in a human or animal body, said medical device comprising an occlusive cuff adapted to surround and seal an anatomical duct of said human or animal body, a fluid reservoir and a tube connecting the reservoir to the occlusive cuff.

[0028] The implementation of such an accessory during the implantation of a medical device in a human or animal body may be as follows: engagement of the collar on a tube, the connection portion of the collar being located on the side of the end to be sealed of the tube; engagement of the connection portion of the stopper with the connection portion of the collar, so as to pinch the end of the tube and to secure the stopper to the collar, insert the stopper sealed by the accessory into the human or animal body up to an implantation site. Brief description of the drawings

[0029] Other features and advantages of the invention will become apparent from the detailed description that follows, with reference to the attached drawings, in which: There figure 1 is a schematic view of a medical device whose implantation is adapted to the implementation of the accessory; The figure 2is a perspective view of a cork according to a particular embodiment; The figure 3 is a perspective view of a collar according to a particular embodiment; The figure 4 is a perspective view of a cork according to another embodiment; The figure 5 illustrates a cap designed to ensure continuity of the outer surface of the cap with respect to the gripping areas; The figure 6 is a perspective view of the connection of the plug of the figure 2 and the collar of the figure 3 using pliers. figure 7 is a perspective view of the connection of the plug of the figure 4 and the collar of the figure 3 using pliers. Detailed description of implementation methods

[0030] The present invention finds application, among other things but not limited to, a number of medical devices, including, for example, artificial sphincters, artificial muscles, electrical stimulators, gastric bands, neurostimulators, vascular prostheses, or penile implants. However, the present invention can be implemented in any other application requiring the creation of a passage into which an elongated shape, such as a tube, is to be inserted.

[0031] There figure 1This illustrates schematically and without limitation an artificial urinary sphincter whose implantation can be facilitated by the use of an accessory according to the invention. Said medical device comprises an occlusive element adapted to surround a natural duct 10. The occlusive element is in the form of an inflatable cuff 1 that can be filled with a variable quantity of fluid, a variation in the fluid pressure inside the cuff varying the compression exerted on the natural duct 10 to be occluded.

[0032] A reservoir 2 of a biocompatible fluid, for example physiological saline, is arranged in fluidic connection with the cuff, via a tube 3.

[0033] The assembly of the cuff 1, reservoir 2 and tube 3 forms the fluid circuit of the medical device.

[0034] This fluidic circuit allows a portion of the fluid from reservoir 2 to be transferred into the sleeve, in order to increase the compression exerted on the conduit 10, and conversely to transfer a portion of the fluid from sleeve 1 to reservoir 2, in order to decrease the compression exerted by the sleeve on the conduit 10.

[0035] For this purpose, the occlusive system further includes an actuation device 4 to carry out this fluid transfer and thus vary the compression exerted by the cuff on the conduit 10.

[0036] A particularly advantageous feature is that tank 2 has a variable volume.

[0037] For example, but not limited to, volume variation can be achieved by moving a wall of the tank. The actuation device 4 includes an actuator for moving said wall, for example, according to the arrangement described in document EP3223748B1. Thus, the tank may include a rolling diaphragm, a piston, a bellows, or any other means for varying its volume. Those skilled in the art can select a suitable actuator from among existing options, depending on the intended implementation with respect to the tank. A piezoelectric actuator is an example, but not limited to.

[0038] The medical device includes a sensor for measuring the action exerted on the reservoir. For example, if the actuation consists of moving a movable wall of the reservoir, the sensor may be a position sensor 5, which determines the position of the movable wall. Calibration allows the determination of, firstly, the relationship between the position of the movable wall and the change in the reservoir's volume; secondly, the relationship between the change in the reservoir's volume and the pressure in the hydraulic circuit; and finally, the relationship between the pressure in the hydraulic circuit and the compression exerted on the occluded conduit. Thus, it is possible to determine the displacement required of the movable wall to obtain a given fluid pressure in the hydraulic circuit, which in turn results in a given compression of the conduit 10 by the sleeve 1.

[0039] The occlusal system further includes a control unit 6 adapted to activate the actuation device 4 so as to exert a specific compression on the conduit 10. The connection 7 between the control unit 6 and the actuation device 4 has been shown in wire diagram form on the figure 1 However, it goes without saying that it could be implemented wirelessly, depending on the technology selected by a person skilled in the art. There is also a connection 7 (wired or wireless) between the sensor 5 and the control unit 6.

[0040] The reservoir 2, the actuation device 4, the control unit 6, and the sensor 5 are arranged in a sealed housing 8 made of a biocompatible material. The housing 8 includes a fluid outlet that is hermetically sealed to the tube 3, ensuring the fluid connection between the reservoir 2 and the tube 3.

[0041] For implantation, cuff 1 and at least a portion of tubing 3 are supplied in sterile packaging, separate from the housing. Housing 8 is also supplied in sterile packaging, with another portion of tubing 3 already connected to the fluid outlet of the housing. Reservoir 2, and, where applicable, tubing 3 and cuff 1, are supplied empty of biocompatible fluid.

[0042] In the case where the reservoir 2, the tube 3 and the sleeve 2 are supplied empty of fluid, a step prior to implantation then consists of purging the fluidic circuit of the air initially contained and filling it with the biocompatible fluid.

[0043] During implantation, the fluidic circuit is kept purged by the accessory which will be described below.

[0044] To implant the medical device, the practitioner must place the cuff around the anatomical duct to be occluded, place the housing in an anatomical region close to the natural duct 10, and connect the fluidic outlet to the cuff 1 via the tube 3.

[0045] To facilitate the implantation of the medical device, an accessory consisting of two interlocking parts is proposed, namely a cap adapted to seal one end of tube 3, and a collar adapted to surround tube 3. The collar and the cap have respective connection portions adapted to cooperate so as to fix the collar and the cap together so as to hermetically seal said end of tube 3.

[0046] There figure 2 is a perspective view of one method of making the stopper.

[0047] The cap 100 extends along a longitudinal axis X.

[0048] The cap 100 includes a circumferential wall 101 which is inscribed in a cylinder with axis of revolution X.

[0049] One end of the cap 100 includes a nozzle 102 adapted for insertion into the tube 3. The outer surface of the circumferential wall 101, together with the nozzle 102, defines an annular groove 103 adapted to receive the tube wall. The diameter of the nozzle 102 is substantially equal to the inner diameter of the tube 3, preferably slightly larger than said inner diameter to allow a tight fit of the tube onto the nozzle 102, so as to ensure a leak-proof connection between the tube 3 and the nozzle 102. The nozzle 102 has a solid shape, so as to seal the tube when it is fitted onto the nozzle 102, which thus penetrates the inside of the tube 3.

[0050] In relation to the tip 102, the inner surface of the circumferential wall 101 includes a cavity 104 which extends over at least a part of this inner surface.

[0051] In some embodiments (not illustrated), the cavity extends through the circumferential wall 101, thus forming a radial opening communicating with the annular groove. Such an opening can, in particular, allow visual verification that the tube 3 is correctly fitted onto the fitting 102.

[0052] The annular groove 103 and the cavity 104 form a portion of the connection of the stopper to the neck.

[0053] On the opposite side to the connection portion in the direction of the longitudinal axis X, the circumferential wall 101 is provided with two zones 105 for gripping the cap by a clamp. The gripping zones 105 may be in the form of two flat surfaces formed on either side of a plane of symmetry of the plug passing through the longitudinal axis X. More generally, the gripping zones may be defined by a localized decrease in the thickness of the circumferential wall 101. The end of the circumferential wall forms a collar 106 delimiting the gripping zones 105 and serving as a support for holding the jaws of a clamp on the gripping zones 105. At the level of the gripping zones 105, the circumferential wall may have a through hole 107. This hole may allow the passage of a suture to facilitate manipulation of the plug during implantation.

[0054] There figure 3is a perspective view of a method of making the collar.

[0055] The collar 200 extends along a longitudinal axis Y which, in the assembled configuration of the accessory, coincides with the longitudinal axis X.

[0056] The collar 200 includes a through opening 201 arranged in its central part around the longitudinal axis Y.

[0057] At one end, the collar 200 includes a collar 202 which extends radially outwards. Advantageously, said collar has a rounded profile, which is not aggressive to the anatomical tissues encountered during implantation.

[0058] At the opposite end of the collar 202 along the longitudinal direction Y, the collar 200 comprises several flexible tabs 203 separated by gaps forming free spaces, oriented along the longitudinal direction Y. Each tab 203 includes a protrusion 204 extending radially outwards. The flexible tabs 203 and protrusions 204 form a connecting portion of the collar to the cap.

[0059] For installation, the collar 200 is fitted around the tube, the fitting direction being chosen so that the connecting portion is on the end end of the tube to be sealed. In other words, the tabs 203 are relatively closer to the end of the tube to be sealed than the collar 202.

[0060] Furthermore, the connection portion of the cap 100 is engaged in the connection portion of the collar 200. In doing so, the tip 102 is inserted at the end and into the inside of the tube 3 and the outer wall of the tube 3 and the tabs 203 of the collar are received in the annular groove 103.

[0061] The plug is secured to the neck by engaging the protrusions 204 of the flexible legs 203 in the cavity 104. For this purpose, the practitioner advantageously uses forceps to facilitate this engagement by exerting pressure on the neck and the plug in opposite directions and according to a closing movement of the jaws of the forceps (cf. figure 6The width of the annular groove 103 is substantially equal to or slightly less than the sum of the thicknesses of the tube and the flexible tabs 203, the cavity 104 being dimensioned to receive each protrusion 204 after elastic deformation of each tab 203 to engage in said annular groove 103. Advantageously, the protrusions 204 and the opening of the annular groove 103 have respective chamfers adapted to facilitate the engagement of the collar 200 in the plug 100.

[0062] Naturally, the protrusions and the groove could be replaced by other connecting means suitable for cooperating to provide a firm fit. In particular, the male connecting portion (such as the protrusions 204) can be arranged on the neck or on the cap, and the female connecting portion (such as the groove and the cavity) can be inversely arranged in the cap or in the neck.

[0063] Once the cap 100 and the collar 200 are joined together, the end of the tube is pinched between the nozzle 102 and the tabs 203, which ensures a fluid seal between the tube 3 and the cap 100.

[0064] There figure 4 is a perspective view of another embodiment of the plug, in which the plug is elongated in shape and further fulfills the function of an insertion guide for tube 3 when the elongated plug 100' and tube 3 are connected during implantation.

[0065] The common reference signs with the figure 2 refer to similar elements or elements fulfilling the same function and which will therefore not be described again.

[0066] According to this particular embodiment of the invention, the 100' cap has a connection portion similar to that of the cap of the figure 2 . Said connection portion includes the annular groove 103 and the tip 102.

[0067] Conversely, on the side opposite the longitudinal connection portion, the plug 100' extends into an elongated stem 108, typically several centimeters long. The stem 108 is solid and advantageously has a conical but not pointed end 109 to facilitate insertion into the tissues without causing significant damage. This stem 108 facilitates the passage of the tube 3 through the tissues between the two implantation sites, one for the cuff 1 and the other for the housing 8.

[0068] In general, the stopper and the neck are free of sharp edges but have connecting fillets in order to minimize the risk of damaging the tissues traversed.

[0069] Like the 100 cap of the figure 2, the cap 100' includes gripping areas 105 which allow the use of pliers for handling the cap or for fitting the cap onto the collar (cf. figure 7 ).

[0070] The pliers typically comprise a first jaw adapted to receive a portion of the stopper opposite the connecting portion of said stopper along the longitudinal direction, and a second jaw adapted to receive a portion of the neck opposite the connecting portion of said neck along the longitudinal direction. These jaws are pivotally movable about an axis of articulation. On the side opposite each jaw relative to the axis of articulation, the pliers comprise two handles adapted for gripping the pliers by a practitioner. In the open position of the pliers, the jaws are separated by a sufficient distance to allow the neck and stopper to be engaged with each respective jaw. When the pliers are closed, the jaws hold the stopper against the neck; the practitioner has leverage to allow easy engagement of the neck and stopper by their respective connecting portions.

[0071] A particularly advantageous feature of the accessory is a cap 300 designed to surround the gripping areas 105, ensuring continuity of the cap's outer surface with respect to these gripping areas after the cap has been fitted onto the neck, for example, using pliers. This continuity of the outer surface along the length of the cap prevents damage to the tissues.

[0072] According to an embodiment illustrated on the figure 5The cap 300 comprises two half-shells 301, 302 that fit together on either side of the cap. When these half-shells are assembled around the cap's gripping area, they present a cylindrical external surface with a diameter substantially the same as the stem 108. Preferably, these half-shells 301, 302 are joined together and hinged. Thus, the practitioner only needs to manipulate one object to position the two half-shells around the cap's gripping area, thereby improving ergonomics.

[0073] There figure 6 illustrates a step in connecting the 100 plug of the figure 2 with the collar 200 using a clamp 400.

[0074] The clamp 400 includes a first jaw 401 adapted to receive a portion of the cap 100 opposite the connecting portion of said cap in the longitudinal direction. Preferably, the first jaw includes a housing adapted to receive the gripping areas 105 of the cap or to bear against the collar 106.

[0075] The clamp includes a second jaw 402 adapted to receive a portion of the collar 200 opposite the connecting portion of said collar in the longitudinal direction. The second jaw 402 includes a housing adapted to receive the collar 202. This housing has a through opening for the passage of the tube 3 onto which the collar 200 has been previously fitted.

[0076] The said jaws 401, 402 are movable by pivoting around an articulation axis 403.

[0077] The clamp 400 further includes handles 405, 404 opposite respectively to the jaws 401, 402 with respect to the articulation axis 403.

[0078] On the figure 6 The clamp is shown in the open position, with the jaws spread apart to allow the cork and collar to be engaged in the jaws.

[0079] To connect the cap and the neck, the user applies pressure to the handles 404, 405 to bring them together, thus bringing the jaws together which, thanks to the pressure they exert on the neck and the cap, allow the mutual engagement of their connecting portions.

[0080] There figure 7 illustrates a step in connecting the 100' cap of the figure 4 with the 200 collar using the 400 clamp, which is identical to that of the figure 6 The clamp will therefore not be described in detail again.

[0081] In this embodiment, preferably the plug 100' is held in the housing of the first jaw 401 by its gripping zones 105, which bear against a surface of the jaw with their edge 106' opposite the connecting portion. This housing has a through opening to allow the passage of the rod 108.

[0082] The forceps can be supplied to the practitioner with one or more plugs and one or more collars, in the form of an implantation kit.

[0083] It is understood that the embodiments described above correspond to particular and non-limiting examples and that various modifications may be made without departing from the invention.

Claims

1. An accessory for implanting a medical device in a human or animal body, said medical device comprising an occlusive cuff (1) adapted to surround and plug an anatomical duct of said human or animal body, a fluid reservoir (2) and a tube (3) connecting the reservoir to the occlusive cuff, said accessory comprising: - a stopper (100; 100') adapted to plug one end of the tube, and - a collar (200) adapted to surround the tube, the stopper (100) and the collar (200) having respective connection portions (103, 104; 203, 204) adapted to cooperate to attach the collar (200) and the stopper (100) together so as to hermetically plug said end of the tube (3), and characterized in that the stopper (100; 100') comprises an end piece (102) adapted to be inserted into an end of the tube, and in that the connection portion of the stopper (100; 100') comprises an annular groove (103) surrounding said end piece (102) configured to receive an elastically deformable end of the collar (200) so as to pinch the end of the tube.

2. The accessory according to claim 1, wherein the connection portions (103, 104; 203, 204) of the stopper and the collar are arranged so as to allow interlocking of the collar with the stopper.

3. The accessory according to one of claims 1 or 2, wherein one of the connection portions of the collar (200) or the stopper (100; 100') has at least one protrusion (204) and the other connection portion of the collar or the stopper has at least one cavity (104), said at least one protrusion being elastically deformable to allow engagement of said at least one protrusion in said at least one cavity.

4. The accessory according to one of claims 1 to 3, wherein the stopper (100') further comprises an elongated rod (108) so as to form a guide for insertion of the tube upon implantation.

5. The accessory according to one of claims 1 to 4, wherein the stopper (100; 100') has at least one gripping zone (105) for pliers (300) configured to connect the collar to the stopper.

6. The accessory according to claim 5, wherein the gripping zone (105) comprises two parallel flats bordered by a flange (106).

7. The accessory according to claim 6, wherein said flats have a suture passage hole (107) therethrough.

8. The accessory according to one of claims 5 to 9, comprising a cap (300) adapted to surround the stopper (100') so as to ensure continuity of the outer surface of the stopper facing the gripping zone (105).

9. The accessory according to claim 8, wherein said cap (300) comprises two interlocking half-shells (301, 302) on either side of the stopper.

10. The accessory according to claim 9, wherein said half-shells (301, 302) are hinged by a hinge.

11. An implantation kit comprising an accessory according to one of claims 1 to 10, and pliers (400) including a first jaw (401) adapted to receive a portion of the stopper (100; 100') opposite to the connection portion of said stopper and a second jaw (402) adapted to receive a portion of the collar (200) opposite to the connection portion of said collar, said jaws being movable between an open position adapted for engagement of the collar and the stopper with each respective jaw and a closed position adapted to connect the collar and the stopper through their respective connection portions.

12. An assembly comprising: - a medical device adapted to be implanted in a human or animal body, said medical device comprising an occlusive cuff (1) adapted to surround and plug an anatomical duct of said human or animal body, a fluid reservoir (2) and a tube (3) connecting the reservoir (2) to the occlusive cuff, and - an accessory according to one of claims 1 to 10 for implanting said medical device in a human or animal body.

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