ASSEMBLY INCLUDING A MEDICAL DEVICE CONFIGURED TO BE IMPLANTED AND PACKAGING FOR THE MEDICAL DEVICE - Patent application

Abstract

The present invention relates to an assembly formed by a medical device (1) configured to be implanted in a human or animal body and by packaging, the medical device including a housing (11) enclosing a fluid reservoir (13) and a fluid outlet (12) forming a fluid connection between the reservoir and a volume external to the housing, the packaging including a tank (2) having a bottom (20), side walls (21), a top surface vertically opposite the bottom, and an opening configured to fill the tank with a biocompatible fluid, the bottom (20) of the tank extending in a horizontal plane perpendicular to the vertical direction, at least one of the bottom, side walls and top surface including a first holding element (201) adapted to hold the housing within the tank, the housing (11) being held within the tank (2) by the first holding element (201) such that the reservoir is positioned between the bottom of the tank and the fluid outlet, the fluid outlet being positioned below the opening such that the fluid outlet is immersed in the fluid when the tank is filled with the biocompatible fluid.

Description

[Technical field]

[0001] The present invention relates to an assembly including a medical device adapted (configured) to be implanted in the human or animal body, which includes a fluid reservoir, and to packaging for said medical device. [Background technology]

[0002] Various implantable medical devices include biocompatible fluid reservoirs that are coupled to fluid circuits that may, for example, enable the operation of elements of the device.

[0003] For example, a device for selectively occluding an anatomical duct, such as the urethra or bladder neck, may include an occlusion cuff that surrounds the anatomical duct and is fluidly coupled to a fluid reservoir. A pump is used to transfer fluid from the reservoir to the cuff to increase compression exerted by the cuff on the duct, or from the cuff to the reservoir to decrease compression exerted by the cuff on the duct.

[0004] Other applications involving fluid reservoirs in medical devices implanted within a patient's body relate to the inflation of occlusion balloons or filling of prostheses.

[0005] Generally, medical devices adapted for implantation are provided to the surgeon in packaging with sterile contents and empty of any biocompatible fluid, so the surgeon must expel the air and fill the reservoirs with biocompatible fluid before implanting in a patient.

[0006] This filling operation must first be performed to evacuate (empty) the fluid circuit of trapped air, since any air bubbles are likely to affect the operation of the implantable device, especially its accuracy.

[0007] Another constraint in the filling operation is maintaining the sterility of the device.

[0008] Manual loading of the device by the surgeon extends the duration of the surgical procedure and introduces the risk of contamination of the device, potentially leading to infection or complications for the patient.

[0009] Although pre-filled medical devices exist, they have a number of drawbacks, for example during the sterilization step where it must be ensured that the fluid is also sterile through the device. Summary of the Invention [Problem to be solved by the invention]

[0010] It is therefore an object of the present invention to define a medical device adapted to be implanted that includes a fluid reservoir and packaging for said medical device that allows for minimal handling of the device prior to implantation. [Means for solving the problem]

[0011] To this end, the present invention relates to an assembly of a medical device adapted to be implanted in the human or animal body and packaging, - the medical device includes a casing surrounding a fluid reservoir and a fluid outlet forming a fluid connection between the fluid reservoir and a volume external to the casing; - the packaging includes a tank, the tank including a bottom, a sidewall, a top surface vertically opposite the bottom, and an opening configured for filling the tank with a biocompatible fluid, the bottom of the tank extending in a horizontal plane perpendicular to the vertical direction, and at least one of the bottom, the sidewall and the top surface including a first retaining element adapted to retain the casing within the tank; The casing is held within the tank by a first retaining element such that the fluid reservoir is positioned between the bottom of the tank and the fluid outlet, the fluid outlet being positioned below the opening such that when the tank is filled with biocompatible fluid, the fluid outlet is submerged in said fluid.

[0012] Such an assembly has the advantage that when the packaging is in its normal use position with the bottom of the reservoir resting on a horizontal surface such as a table, it provides an easy-to-drain positioning of the medical device with the fluid outlet located above the reservoir, so that once the reservoir is filled with biocompatible fluid, draining can be performed without any handling of the device.

[0013] As used herein, "vertical" means a direction parallel to the direction of gravity, as indicated by a plumb line, and "horizontal" means a direction contained in a plane perpendicular to said vertical direction. Furthermore, the terms "above" or "below" or "upper" or "lower" are understood to be relative to said vertical direction.

[0014] In some embodiments, the medical device includes tubing in fluid connection with the fluid outlet, and a bottom and / or sidewall of the reservoir includes a second retaining element adapted to retain a portion of the tubing.

[0015] In some embodiments, the opening is located in the top surface of the tank. Alternatively, the opening is located in an upper portion of the sidewall.

[0016] In some embodiments, the packaging further comprises a cover removable from the tank to at least partially cover the opening.

[0017] The cover may be configured to be secured to only a portion of the at least one sidewall, the cover having at least one gripping zone spaced from the at least one sidewall.

[0018] In some embodiments, the cover further comprises a third retaining element adapted to retain the casing in a position where the reservoir is positioned between the bottom of the tank and the fluid outlet.

[0019] Each holding element of the tank and, if applicable, the cover, is in the form of a housing adapted to hold the casing and / or the tubing, if present, by friction.

[0020] In some embodiments, the tank is formed by molding a plastic material, in which case the housings may be formed during the molding process.

[0021] In some embodiments, the tank includes a levelness indicator on the bottom of the tank.

[0022] The level indicator is a level indicator of the fluid level in the tank.

[0023] In some embodiments, the packaging further comprises a tub adapted to receive the tank.

[0024] In some embodiments, the assembly further includes a sterilizing gas permeable first seal integral with at least one sidewall, the tab and the first seal together forming a sterile enclosure for the medical device.

[0025] The assembly further includes a second seal permeable to sterilizing gas that seals the tub, the tub and the second seal together forming a sterile enclosure for the tank.

[0026] In some embodiments, the fluid reservoir includes a fixed wall and a wall movable relative to the fixed portion to change the volume of the reservoir, the change in volume of the reservoir being adapted for and automatically filling with a biocompatible fluid and draining a fluid circuit extending between the reservoir and a fluid outlet.

[0027] Advantageously, the medical device includes an electromechanical actuator disposed within the casing, the electromechanical actuator configured to move a moveable wall of the reservoir to vary the volume of the reservoir.

[0028] In some embodiments, the casing includes a single fluid outlet and a single fluid connection between the fluid reservoir and the fluid outlet.

[0029] In some embodiments, the medical device is selected from the group consisting of an artificial sphincter, an artificial muscle, an electrical stimulator, a gastric band, a neurostimulator, and a penile implant.

[0030] Further features and advantages of the present invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings. [Brief description of the drawings]

[0031] [Figure 1] FIG. 1 is a cross-sectional view of a medical device according to one embodiment. [Diagram 2] FIG. 2 is an exploded view of packaging according to one embodiment. [Diagram 3] FIG. [Figure 4] FIG. 3 is a cross-sectional view of the assembled packaging of FIG. 2. [Diagram 5] FIG. 1 is a perspective view of a medical device in its packaging. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0032] The medical device includes a casing made of a biocompatible material, such as titanium.

[0033] The casing contains a reservoir of a biocompatible fluid and comprises a fluid outlet forming a fluid connection between the reservoir and an environment external to the medical device. The fluid outlet may in particular be connected to tubing providing a fluid connection with an element external to the casing. Preferably, the biocompatible fluid is a liquid.

[0034] According to an alternative embodiment, the reservoir includes a movable wall driven by an actuator, the movement of which allows the volume of the reservoir to be controllably varied, said volume variation allowing fluid to be transferred from the reservoir to the fluid outlet or from the fluid outlet to the reservoir.

[0035] Particularly advantageously, the actuator is an electromechanical actuator, which is controlled by a control unit to move the movable wall a specified distance. The control unit can be located within the casing. Thus, the medical device is autonomous in the sense that it does not require any action by the medical practitioner to perform its functions.

[0036] Additionally, the device advantageously includes a single fluid outlet and a single fluid circuit between the reservoir and the fluid outlet.

[0037] In some applications, the medical device is an artificial sphincter intended to selectively occlude an anatomical duct by exerting a compressive force on the anatomical duct. In particular, the medical device may be an artificial urinary sphincter.

[0038] In such devices, compression is applied to the anatomical duct by means of an occlusion cuff connected by tubing to the fluid outlet of the casing, and an electromechanical actuator allows fluid to be transferred from the reservoir to the cuff or vice versa by moving a movable wall to adjust the compression applied by the cuff.

[0039] An example of such a medical device is described in US Pat. No. 5,399,633.

[0040] FIG. 1 illustrates one embodiment of a medical device.

[0041] Medical devices include: - Sealed casing for containing gas 11 - Fluid outlet 12 a fluid reservoir 13 having a variable fluid volume disposed within the casing in fluid communication with the fluid outlet 12;

[0042] Particularly advantageously, the reservoir comprises a fixed wall and a wall movable relative to the fixed wall, the movement of the movable wall enabling the volume of the reservoir 13 to be changed.

[0043] According to an advantageous but non-limiting embodiment, the fixed wall of the reservoir may be formed in a portion of the inner wall of the casing 11 , and a movable wall 130 , which is preferably rigid, is connected to the fixed wall by a deformable bellows 131 .

[0044] An actuator 14 is disposed within the casing 11 and is mechanically coupled to the moveable wall 130 to selectively vary the volume of fluid within the reservoir.

[0045] The actuator 14 may be configured to control the linear movement of the movable wall 130, the bellows 131 being adapted (configured) to expand or compress as a function of said linear movement of the movable wall 130 controlled by the actuator 14.

[0046] The actuator 14 may be selected from any electromechanical system for converting electrical energy into mechanical motion with the required power to enable the movement of the movable wall 130 of the variable volume tank 13 with the required force and speed. The actuator 14 may be, among others, a piezoelectric actuator, an electromagnetic actuator which may include a brush or brushless electromagnetic motor coupled or not to a gearbox, an electroactive polymer, or a shape memory alloy.

[0047] The movable wall 130 may be moved translationally along the longitudinal axis by the action of a drive screw 17 integral to the movable wall 130. The movable wall 130 is coupled to the drive screw 17 by means of a nut 170 integral to the movable wall 130 and having an internal thread cooperating with the thread of the drive screw 17. The drive screw 17 may extend substantially along the longitudinal axis. The position of the drive screw 17 may correspond substantially to the center of the movable wall 130.

[0048] The actuator 14 is adapted to rotatably drive, for example through rotation of gears, the drive screw 17. Rotation of the drive screw 17 about the longitudinal axis causes the moveable wall 130 to move along the longitudinal axis, and the bellows 131 to correspondingly compress or expand along the longitudinal axis.

[0049] The actuator 14 may include a motor 140 coupled to a gearbox. A connector 141 provides power to the motor 140 as a function of the motor movement command.

[0050] The gearbox is coupled to a gear wheel 18 for transmitting torque and rotation from the shaft of the motor 140 to the drive screw 17, which in turn is coupled to the drive screw 17. The drive system thus comprises a nut coupled to the drive screw and rotatably movable on a double-acting ball stop about the axis of the screw under driving action by the actuator 14, the nut being coupled to the screw such that rotation of the nut drives the screw only translationally in the direction of movement of the moving part.

[0051] Rotation of the screw 17 then drives the nut translationally, so that the movable wall 130 is translated in a direction parallel to the axis of the screw, i.e. in the direction of the longitudinal axis. The direction of movement of the movable wall 130 depends on the direction of rotation of the motor 140.

[0052] The gear wheel 18 is housed within the block 15 by ball bearings 16 which allow it to rotate within the block 15 .

[0053] It will be appreciated that FIG. 1 shows one embodiment of a medical device by way of example only, and any other configuration of variable volume reservoirs and actuators may be defined by one skilled in the art to perform the functions of said medical device.

[0054] Such devices differ from artificial sphincters, which include a pump, pressure regulating balloon and cuff that are manually operable by the patient, in that they have controllable autonomous operation without repetitive manual operation by the patient.

[0055] In other applications, the medical device may be an artificial muscle, an electrical stimulator, a gastric band, a neurostimulator, or a penile implant (a non-limiting list).

[0056] Between the manufacturing site of the medical device and the operating room where it is implanted in the patient, the medical device is placed in a packaging, which is the subject of this text. Said packaging is adapted to maintain sterility by protecting the medical device from external contamination and to protect the medical device from impacts. In the packaging, the medical device is empty of biocompatible fluids, the filling of the fluid circuits being carried out only in the operating room.

[0057] As described below, the packaging is further adapted to allow the fluid circuit to be drained (emptied) by a practitioner in an operating room without handling the medical device.

[0058] The packaging firstly comprises a tank, in which the medical device is held in a so-called vertical position, i.e. positioned within the tank between a bottom of the tank and the fluid outlet.

[0059] The tank includes a horizontal bottom, sidewalls, and a top surface vertically opposite the bottom.

[0060] The reservoir includes at least one opening configured to allow the reservoir to be filled with a biocompatible fluid.

[0061] The fluid outlet of the medical device is located below said opening so that when the reservoir is filled the entire medical device, including the fluid outlet, is submerged in the fluid.

[0062] To ensure that filling the reservoir with biocompatible fluid is sufficient to carry out the drainage method, the reservoir can advantageously include a visual level indicator located at the top of the reservoir. Advantageously, the volume of the reservoir and the position of the indicator are selected and dimensioned to allow filling of the reservoir of the device. Alternatively, to regulate the overflow of this fluid and to avoid overfilling, the reservoir can include a cavity at the top intended to receive an overflow of biocompatible fluid.

[0063] The medical device is held in a vertical position by first holding elements located on the bottom, sidewalls and / or top surface of the tank.

[0064] According to one embodiment, the first retaining element is in the form of a housing, the dimensions of which are adapted to receive a portion of the casing by applying a slight clamping action so as to hold the casing in the desired position without damaging the casing.

[0065] Advantageously, said housing is arranged at the bottom of the tank.

[0066] According to a preferred embodiment, the tank is made, for example, by molding or forming a plastic material, and the housing is integrated into the bottom of the tank by molding or forming. The housing may, for example, be in the form of two parallel partitions spaced apart by the width of the casing.

[0067] In some embodiments, the medical device may be packaged with tubing in fluid connection with the fluid outlet, in which case the casing advantageously includes a second retention element disposed on the bottom and / or sidewall of the tank to retain a portion of the tubing below the fluid outlet.

[0068] Advantageously, said second holding element is in the form of a housing arranged at the bottom of the tank parallel to the casing housing, which may for example be in the form of two parallel partitions spaced apart by the diameter of the tubing.

[0069] According to one suitable embodiment depicted in the figures, the tank has the shape of a parallelepiped with four side walls and a bottom, the side opposite the bottom being open, however, this particular shape is by no means limiting.

[0070] Thus, according to other embodiments not shown, the tank may have any other shape, such as, for example, a cylindrical shape with a cylindrical side wall and a circular bottom.

[0071] Particularly advantageously, the bottom of the tank has substantially identical dimensions in two orthogonal directions in a horizontal plane to ensure the stability of the tank, in particular to avoid the tank tipping over when the medical device is discharged.

[0072] According to some embodiments not shown, the opening of the reservoir may be located in the sidewall of the reservoir rather than on the top surface of the reservoir, preferably at the top of the sidewall, above the fluid outlet of the medical device.

[0073] In any case, the reservoir is dimensioned and the openings are arranged so that, when the bottom of the reservoir extends in a horizontal plane, the reservoir can be filled with biocompatible fluid at least up to the level of the fluid outlet of the medical device, preferably above said outlet. Thus, after evacuation, the entire fluid circuit extending between the reservoir and the fluid outlet can be filled with biocompatible fluid and any air initially present can be evacuated. In particular, filling and evacuation can be performed through said fluid outlet by varying the volume of the reservoir, without requiring any user intervention other than the activation of said volume variation, thus avoiding any contamination.

[0074] Advantageously, the packaging further comprises a cover removable from the tank to at least partially close the opening, the cover preferably being snap-fitted and retained on the side wall, for example by friction or snap-fit.

[0075] According to a preferred embodiment, the cover is configured to be secured to only a portion of the side wall, and the cover has at least one gripping zone spaced from the side wall. For example, the cover may have a contour having a portion that matches the shape of an opening defined by the side wall and a portion recessed from the side wall to form a passageway to facilitate gripping the cover with the practitioner's fingers.

[0076] Particularly advantageously, the cover has a further holding element adapted to hold the medical device in a vertical position, which may be in the form of a housing arranged facing the housing formed in the tank, so that the medical device is held in a vertical position in two places, which improves its stability, in particular during its transport.

[0077] As with the tank, the cover can be made by molding or forming a plastic material, and the housing is integrated inside the cover by molding or forming. The housing can be, for example, in the form of two parallel partitions spaced apart by the width of the casing.

[0078] In some embodiments, the packaging includes a tub for housing the reservoir. The tub provides additional protection of the medical device against impacts. Advantageously, the tub also forms a sterile enclosure for the reservoir, thereby enhancing protection of the medical device from external contaminants. Preferably, during the implantation procedure, the tub can be handled and opened outside the sterilization room of the operating theater so that the reservoir can be extracted from the tub and passed through the sterilization room. The reservoir is then opened and handled by the practitioner in the sterilization room. Furthermore, as explained below, the tub can be used in a drainage method by filling it with a biocompatible fluid.

[0079] A method of packaging a medical device, using the packaging illustrated in FIG. 2, can be carried out as follows.

[0080] The assembled medical device 1 is placed in a tank 2. For this purpose, the medical device engages into a holding element provided in the tank to hold said device with a fluid outlet above the tank. When the fluid outlet is connected to tubing, said tubing preferably also engages into a holding element provided in the tank to hold said tubing at the bottom of the tank.

[0081] 3, the tank 2 includes a bottom 20 and a sidewall 21 extending substantially vertically from the bottom 20. Opposite the bottom 20, the sidewall 21 has an edge 22 extending outwardly in a horizontal plane. The edge 22 defines an upper surface of the tank that includes an opening 24.

[0082] As described above with reference to Figure 1, the medical device 1 includes a casing 11 in which a biocompatible fluid reservoir 13 (shown in dotted lines in Figure 4) is disposed. The medical device 1 further includes a fluid outlet 12 connected to the casing 11 and in fluid communication with the reservoir 13. The fluid outlet 12 provides a fluid connection between the reservoir and the outside of the casing. The fluid outlet 12 is connected to tubing 10 that is intended to be connected to an occlusion cuff during implantation.

[0083] The height of the side wall 21 is greater than the height of the medical device in its vertical packing position. Thus, as shown in Figures 4 and 5, when the medical device 1 is placed in the tank 2, the medical device is completely contained within the tank 2. The fluid outlet 12 is located below the opening 24 so that the fluid outlet can be covered with fluid when the tank is filled. The reservoir 13 is located below the fluid outlet 12 when the medical device is placed in the tank.

[0084] The bottom 20 has a substantially square shape to ensure the stability of the tank.

[0085] The bottom 20 of the tank 2 includes a housing 201 adapted to hold a medical device in a vertical position. The housing 201 is defined as a cavity formed in the bottom 20, parallel to one of the sides, and extends substantially between the center of one side of the bottom 20 and the center of the opposite side. The location of the housing is in the central area of ​​the bottom to ensure stability of the tank-medical device assembly when the medical device is placed in the housing and the tank is filled with a biocompatible fluid. The width of the housing is substantially equal to the width of the medical device to allow the medical device to be inserted and held in the housing. The depth of the housing is selected to avoid any tipping of the casing 11, a depth of 5 to 15 mm being adapted for this function.

[0086] Particularly advantageously, the housing 201 comprises two pairs of rounded projections (not shown), each pair of projections arranged opposite each other across the width of the housing 201. Each pair of projections locally limits the width of the housing 201 and thereby exerts a slight clamping action on the medical device to hold it in place.

[0087] The tank bottom 20 further comprises a housing 203 for the tubing 10 of the medical device. The width of said housing is substantially equal to the diameter of the tubing. Said housing is in the form of two parallel studs 204 raised relative to the bottom 20. Advantageously, with respect to the housing 201, the studs have a pair of rounded projections (not shown) facing each other in the width direction of the housing 203. Said pair of projections locally limits the width of the housing 203 and thus exerts a slight clamping effect on the tubing. Advantageously, the housing 203 is parallel to the housing 201.

[0088] Alternatively, the housing 201 can be defined by one or more pairs of opposing studs that are raised relative to the bottom of the tank. As for the housing 203, it can be defined as a cavity in the bottom of the tank. Any other shape adapted to hold the medical device in a vertical position can be used.

[0089] A cover 3 is placed on top of the reservoir 2. A medical device is then engaged with a holding element provided on the cover for holding said device with a fluid outlet above the reservoir.

[0090] For example, the cover may include a housing 30 formed therein facing the housing 201. The housing 30 may be defined by two raised studs against the inner surface of the cover or as a hollow formed in the inner surface of the cover. The width of the housing 30 is substantially equal to the width of the top of the medical device 1 in a vertical position.

[0091] Advantageously, the cover 3 is substantially cross-shaped, so that it blocks only a portion of the upper opening of the tank 2, leaving openings at the corners of the tank adapted for the practitioner to grip the cover at a gripping zone 31.

[0092] The shape and dimensions of each of the edges of the cover 3 and the side walls 21 are selected to enable the cover to be snap-fitted onto the tank. In particular, the side walls 21 may include at their upper portion a flange 25 adapted to hold the respective edge of the cover 3.

[0093] A first sheet 4 permeable to sterilizing gases, for example made of Tyvek™, is then sealed to the upper edge 22 of the tank.

[0094] The tank 2 is then placed in the tub 5 .

[0095] The tub 5 has a similar shape to the tank 2, but larger dimensions. Preferably, the tub 5 is of a size sufficient to fully receive the tank 2 while minimizing the free space between the tank 2 and the tub 5, in order to minimize the overall size of the packaging.

[0096] The tub 5 has a substantially planar base 50 and a sidewall extending substantially perpendicularly from the base 50. Opposite the base 50, the sidewall 51 has an edge 52 extending outwardly in a horizontal plane. The edge 52 defines an upper surface of the tub with a central opening.

[0097] Advantageously, the tub 5 has an inner flange 53 which provides support for the flange 22 of the tank 2 .

[0098] Like the bottom 20 of the tank, the bottom 50 of the tub 5 is substantially square to ensure good stability of the tub.

[0099] A second sheet 6 that is permeable to sterilizing gases, such as a seal made from Tyvek™, is then sealed to the upper edge 52 of the tub 5 .

[0100] The sealed packaging is then sterilized by any suitable means and then packed into a box (not shown) constituting the outer envelope, and the medical device, within the outer envelope, is delivered to a medical practitioner for implantation within a patient.

[0101] For this implantation, the practitioner removes the packaging from the box, removes the second sealing sheet, removes the tank and then removes the first sealing sheet.

[0102] According to one embodiment, the practitioner removes the reservoir from the tub in order to fill it with a biocompatible fluid.

[0103] To perform this filling and draining, the practitioner must ensure that the bottom of the tank is level.

[0104] Levelness of the tank bottom can be ensured by placing the bottom of the tank on a flat, horizontal surface, such as a table.

[0105] This levelness can be checked using a suitable indicator. For example, such a levelness indicator may be an indicator of the levelness of the water level in the tank. Such an indicator may be in the form of, for example, one or more segments formed in the tank, for example directly formed by molding or even by printing, and located at the top of the tank, parallel to the bottom. Such an indicator may also serve as a filling indicator for the practitioner, showing him how high to pour the biocompatible fluid into the tank to allow effective drainage. Figure 3 illustrates one embodiment of such a levelness indicator in the form of a hollow or raised internal line 23 extending in a horizontal plane in the side wall 21. Preferably, said internal line 23 extends continuously or discontinuously on several sides of the side wall 21.

[0106] An indication of the levelness of the tank bottom may also be provided by the medical device itself. In practice, the device typically includes an accelerometer located within the casing that can be used to determine the patient's posture or activity when the medical device is implanted. Since the casing is integrated with the tank bottom at a determined orientation (usually vertical) relative to the tank bottom, the accelerometer can provide an indication of the inclination of the tank bottom.

[0107] Alternatively or additionally, this levelness can be ensured by placing a tank within the fluid-filled container, where the tank is dimensioned such that when the tank contains the medical device in its intended position for discharge, the medical device floats within the container while maintaining the fluid outlet of the medical device above the tank.

[0108] The tub in which the tank is placed within the packaging may be used as a container for this purpose.

[0109] The practitioner then fills the reservoir with a biocompatible fluid intended for the operation of the medical device, said fluid may be, for example, saline.

[0110] The practitioner then activates the actuator of the medical device to expel any air, if any, present in the fluid circuit extending between the reservoir and the fluid outlet into the tubing and to fill said fluid circuit and tubing with biocompatible fluid. The actuator can be activated several times, e.g., three times, to move the movable wall of the reservoir and change its volume, thus applying a pumping action, until the fluid circuit is completely evacuated (no air bubbles exiting the fluid outlet).

[0111] This activation of the actuator does not require any handling of the medical device itself: in fact, the medical device contains means of wireless communication with an external remote control, which makes it possible to parameterize the device and to send it activation or deactivation commands.

[0112] Once drainage is complete, the practitioner can close the fluid outlet or the end of the tubing, if present, and remove the medical device from the reservoir for the implantation procedure.

[0113] Thus, prior to implantation, the medical device is not touched by the practitioner, thus avoiding or at least minimizing the risk of contamination of the device.

[0114] In addition, no practitioner intervention is required during the evacuation process. In fact, once evacuation is initiated, the actuator of the device aspirates the biocompatible fluid and expels the air. This allows the practitioner to focus on other tasks, such as implant preparation. Thus, the operation time can be significantly reduced.

[0115] Finally, the fact that the ejection process is automatic increases the reliability of the method.

[0116] It will be understood that the above-described embodiments are specific and non-limiting examples and that various modifications can be made without departing from the invention. [Prior art documents] [Patent documents]

[0117] [Patent Document 1] International Publication No. WO2016 / 083428

Claims

1. 1. An assembly of a medical device and packaging adapted to be implanted in a human or animal body, comprising: - said medical device comprises a casing surrounding a fluid reservoir and a fluid outlet forming a fluid connection between said fluid reservoir and a volume external to said casing; the packaging comprises a tank having a bottom, a sidewall, a top surface vertically opposite the bottom, and an opening configured for filling the tank with a biocompatible fluid, the bottom of the tank extending in a horizontal plane perpendicular to the vertical direction, and at least one of the bottom, the sidewall and the top surface comprising a first retaining element adapted to retain the casing within the tank; the casing is held within the tank by the first retaining element such that the fluid reservoir is positioned between the bottom of the tank and the fluid outlet, the fluid outlet being positioned below the opening such that the fluid outlet is submerged in the biocompatible fluid when the tank is filled with the biocompatible fluid; assembly.

2. The assembly of claim 1 , wherein the medical device includes tubing fluidly connected to the fluid outlet, and the bottom and / or the side wall of the tank includes a second retaining element adapted to retain a portion of the tubing.

3. The assembly of claim 1 or 2, wherein the opening is located in the top surface of the tank.

4. The assembly of claim 1 or 2, wherein the opening is located in an upper portion of the side wall.

5. The assembly of claim 2 further comprising a cover removable from said tank to at least partially block said opening.

6. The assembly of claim 5 , wherein the cover is configured to be secured to only a portion of the side wall, the cover having at least one gripping zone spaced from the side wall.

7. 7. The assembly of claim 5 or 6, wherein the cover further comprises a third retaining element adapted to retain the casing in a position where the tank is positioned between the bottom of the tank and the fluid outlet.

8. 8. The assembly of claim 7, wherein each retaining element is a housing adapted to frictionally retain the casing and / or the tubing.

9. 9. The assembly of claim 8, wherein the tank is formed by molding a plastic material and each housing is integrally molded.

10. An assembly according to any one of the preceding claims, wherein the tank includes a levelness indicator on the bottom of the tank.

11. 11. The assembly of claim 10, wherein the level indicator on the bottom of the tank is a level indicator of a fluid level within the tank.

12. The assembly of any one of claims 1 to 11, further comprising a tub adapted to receive the tank.

13. 13. The assembly of any one of claims 1 to 12, further comprising a sterilizing gas permeable first seal integral with the side wall, the tank and the first seal together forming a sterile enclosure for the medical device.

14. 14. The assembly of claim 13 when dependent on claim 12, further comprising a second seal permeable to sterilizing gas sealing the tub, the tub and the second seal together forming a sterile enclosure for the tank.

15. 15. The assembly of claim 1, wherein the fluid reservoir comprises a fixed wall and a wall movable relative to the fixed wall to change the volume of the fluid reservoir, the change in the volume of the fluid reservoir being adapted for filling with a biocompatible fluid and draining the biocompatible fluid from a fluid circuit extending between the fluid reservoir and the fluid outlet.

16. 16. The assembly of claim 15, wherein the medical device includes an electromechanical actuator disposed within the casing, the electromechanical actuator configured to move the movable wall of the fluid reservoir to change the volume of the fluid reservoir.

17. An assembly according to any preceding claim, wherein the casing includes a single fluid outlet and a single fluid connection between the fluid reservoir and the fluid outlet.

18. 18. The assembly of any one of claims 1 to 17, wherein the medical device is selected from the group consisting of an artificial sphincter, an artificial muscle, an artificial stimulator, a gastric band, a neurostimulator, and a penile implant.

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