A component including a medical device adapted for implantation and a package for the device

Abstract

The present invention relates to a component formed by a medical device (1) suitable for implantation into a human or animal body and a package, wherein: - the medical device comprises a housing (11) and a fluid outlet (12), the housing enclosing a fluid storage portion (13), the fluid outlet forming a fluid connection between the storage portion and a volume outside the housing; - the package comprises a reservoir (2), the reservoir comprising a bottom (20), side walls (21), an upper surface opposite the bottom in the vertical direction, and an opening configured to fill the reservoir with a biocompatible fluid, the bottom (20) of the reservoir extending in a horizontal plane perpendicular to the vertical direction; - at least one of the bottom, the side walls and the upper surface comprises a first holding element (201) adapted to hold the housing in the reservoir, the housing (11) being held in the reservoir (2) by the first holding element (201) such that the storage portion is located between the bottom of the reservoir and the fluid outlet, the fluid outlet being arranged below the opening such that when the reservoir is filled with the biocompatible fluid, the fluid outlet is immersed in the fluid.

Description

Technical Field

[0001] The present invention relates to a component including a medical device adapted to be implanted in a human or animal body and a package for said device, the medical device including a fluid reservoir. Background Art

[0002] Various implantable medical devices include a biocompatible fluid reservoir coupled to a fluid circuit. Such a fluid circuit can enable the actuation of the elements of the device, for example.

[0003] For example, a device for selectively closing an anatomical duct (e.g., the urethra or bladder neck) may include an occlusive cuff that surrounds said 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 the pressure exerted by the cuff on the duct, or to transfer fluid from the cuff to the reservoir to reduce the pressure exerted by the cuff on the duct.

[0004] Other applications of fluid reservoirs in medical devices implanted in patients relate to the inflation of occlusive balloons or the filling of prostheses.

[0005] Generally, implantable medical devices are provided to surgeons in a package containing sterile contents without any biocompatible fluid. Therefore, before implanting in a patient, the surgeon must expel the air and fill the reservoir with biocompatible fluid.

[0006] This filling operation must be carried out to empty the fluid circuit that initially contains air. In fact, any air bubbles can affect the operation of the implantable device, especially its accuracy.

[0007] Another limitation of the filling operation lies in maintaining the sterility of the device.

[0008] Manually filling the device by the surgeon prolongs the duration of the surgical procedure and poses a risk of contaminating the device, which may lead to patient infection or complications.

[0009] There are pre-filled medical devices, but these pre-filled medical devices have many drawbacks. For example, during the sterilization step, it is necessary to ensure that the fluid is also sterilized through the device. Summary of the Invention

[0010] Therefore, an object of the present invention is to define an implantable medical device and a package for said device, the medical device including a fluid reservoir, and the medical device and the package together minimizing the operation of the device before implantation to the greatest extent.

[0011] To this end, the present invention relates to a component of an implantable medical device and a package, wherein:

[0012] - The medical device includes a housing and a fluid outlet. The housing encloses a fluid storage portion. The fluid outlet forms a fluid connection between the storage portion and a volume outside the housing.

[0013] - The package includes a reservoir. The reservoir includes a bottom, side walls, an upper surface opposite the bottom in a vertical direction, and an opening configured to fill the reservoir with a biocompatible fluid. The bottom of the reservoir extends in a horizontal plane perpendicular to the vertical direction. At least one of the bottom, side walls, and upper surface includes a first retaining element adapted to hold the reservoir in place.

[0014] The housing is held in the reservoir by the first retaining element such that the storage portion is positioned between the bottom of the reservoir and the fluid outlet. The fluid outlet is arranged below the opening such that when the reservoir is filled with the biocompatible fluid, the fluid outlet is immersed in the fluid.

[0015] An advantage of such an assembly is that when the package is in its normal use position, it provides a positioning that facilitates the emptying of the medical device. In this normal use position, the fluid outlet is located above the storage portion, and the bottom of the reservoir lies on a horizontal surface such as a table. Thus, once the reservoir is filled with the biocompatible fluid, emptying can be carried out without any operation on the device.

[0016] As used herein, "vertical" refers to a direction parallel to the direction of gravity, e.g., the direction indicated by a plumb line, and "horizontal" refers to a direction contained in a plane perpendicular to the vertical direction. Additionally, the terms "above" or "below" or "upper" or "lower" are understood with respect to the vertical direction.

[0017] In some embodiments, the medical device includes a pipe fluidly connected to the fluid outlet. The bottom and / or side walls of the reservoir include a second retaining element adapted to hold a portion of the pipe.

[0018] In some embodiments, the opening is arranged on the upper surface of the reservoir. Alternatively, the opening is arranged in an upper portion of the side wall.

[0019] In some embodiments, the package further includes a lid that can be removed from the reservoir to at least partially block the opening.

[0020] The lid may be configured to be fixed only to a portion of at least one side wall, and the lid has at least one gripping area away from the at least one side wall.

[0021] In some embodiments, the lid further has a third retaining element adapted to hold the housing in a position where the storage portion is between the bottom of the reservoir and the fluid outlet.

[0022] Each retaining element of the reservoir and the lid (if applicable) can be in the form of a receptacle adapted to retain the housing and / or the conduit (if any) by friction.

[0023] In some embodiments, the reservoir is formed by molding a plastic material, and then each receptacle can be formed during the molding process.

[0024] In some embodiments, the reservoir includes a level indicator at the bottom of the reservoir.

[0025] The indicator can be a level indicator of the liquid level in the reservoir.

[0026] In some embodiments, the package further includes a barrel portion adapted to receive the reservoir.

[0027] In some embodiments, the assembly further includes a first seal permeable to a sterilizing gas, the first seal being integral with at least one sidewall, and the barrel portion and the first seal together form a sterile enclosure for the medical device.

[0028] The assembly can further include a second seal permeable to a sterilizing gas, the second seal plugging the barrel portion, and the barrel portion and the second seal together form a sterile enclosure for the reservoir.

[0029] In some embodiments, the storage portion includes a fixed wall and a wall movable relative to the fixed portion to change the volume of the storage portion, and the change in the volume of the storage portion is adapted to automatically fill the biocompatible fluid and empty the fluid circuit extending between the storage portion and the fluid outlet.

[0030] Advantageously, the medical device includes an electromechanical actuator disposed in the housing, the actuator being configured to move the movable wall of the storage portion to change the volume of the storage portion.

[0031] In some embodiments, the housing includes a single fluid outlet and a single fluid connection between the storage portion and the fluid outlet.

[0032] 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 nerve stimulator, and a penile implant. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Other features and advantages of the present invention will become apparent from the following detailed description and with reference to the accompanying drawings, in which:

[0034] - Figure 1 is a cross-sectional view of a medical device according to one embodiment;

[0035] - Figure 2 is an exploded view of a package according to one embodiment;

[0036] - Figure 3 is a perspective view of a storage tank;

[0037] - Figure 4 is Figure 2 a cross-sectional view of an assembled package of;

[0038] - Figure 5 is a perspective view of a medical device located in its package. Detailed Description

[0039] The medical device includes a housing made of a biocompatible material (e.g., titanium).

[0040] The housing includes a storage portion for a biocompatible fluid and is provided with a fluid outlet that forms a fluid connection between the storage portion and the external environment of the medical device. The fluid outlet can in particular be connected to a pipe that provides a fluid connection to an element outside the housing. Preferably, the biocompatible fluid is a liquid.

[0041] According to an alternative embodiment, the storage portion includes a movable wall driven by an actuator, and the movement of the movable wall enables the volume of the storage portion to be controllably changed. This volume change enables the fluid to move from the storage portion to the fluid outlet or from the fluid outlet to the storage portion.

[0042] Particularly advantageously, the actuator is an electromechanical actuator that is controlled by a control unit to move the movable wall a specific distance. The control unit can be arranged in the housing. Thus, the medical device is automatic in the sense that it does not require action by a physician to perform its function.

[0043] Furthermore, the device advantageously includes a single fluid outlet and a single fluid circuit located between the storage portion and the fluid outlet.

[0044] In some applications, the medical device is an artificial sphincter designed to selectively occlude an anatomical duct by applying pressure on the duct. In particular, the medical device can be an artificial urinary sphincter.

[0045] In such a device, pressure is applied on the anatomical duct by means of an occlusion cuff connected to the fluid outlet of the housing through a pipe. By moving the movable wall, the electromechanical actuator enables the fluid to be transferred from the storage portion to the cuff or from the cuff to the storage portion to adjust the pressure applied by the cuff.

[0046] Examples of such medical devices are described in WO 2016 / 083428.

[0047] Figure 1 An embodiment of the medical device is shown.

[0048] The medical device includes:

[0049] - A sealed housing 11 containing gas,

[0050] - A fluid outlet 12,

[0051] - A fluid storage section 13 having a variable fluid volume, which is arranged in the housing and is fluidly connected to the fluid outlet 12.

[0052] Advantageously, the storage section includes a fixed wall and a wall movable relative to the fixed wall, and the movement of the movable wall enables the volume of the storage section 13 to be changed.

[0053] According to an advantageous but non - limiting embodiment, the fixed wall of the storage section may be formed as a part of the inner wall of the housing 11, and preferably, the rigid movable wall 130 is connected to the fixed wall by a deformable bellows 131.

[0054] An actuator 14 is arranged in the housing 11 and is mechanically coupled to the movable wall 130 to selectively change the fluid volume in the storage section.

[0055] The actuator 14 is adapted to control the linear movement of the movable wall 130, and the bellows 131 is adapted to elongate or compress according to the linear movement of the movable wall 130 controlled by the actuator 14.

[0056] The actuator 14 can be selected from any electromechanical system for converting electrical energy into mechanical motion with the required power to enable the movable wall 130 of the variable - volume reservoir 13 to move with the required force and speed. The actuator 14 can in particular be a piezoelectric actuator, an electromagnetic actuator, an electro - active polymer or a shape - memory alloy. The electromagnetic actuator can include a brushed or brushless electromagnetic motor, which may or may not be coupled to a gearbox.

[0057] The movable wall 130 can be translated along the longitudinal axis by the action of a drive screw 17 integral with the movable wall 130. The movable wall 130 is coupled to the drive screw 17 by a nut 170, which is integral with the movable wall 130 and has an internal thread that mates with the thread of the screw 17. The drive screw 17 can extend substantially along the longitudinal axis. The position of the drive screw 17 can substantially correspond to the center of the movable wall 130.

[0058] The actuator 14 is adapted to rotatably drive the drive screw 17, for example, by the rotation of a gear. The rotation of the drive screw 17 about the longitudinal axis causes the movable wall 130 to move along the longitudinal axis, where the bellows 131 is correspondingly compressed or elongated along the longitudinal axis.

[0059] The actuator 14 can include a motor 140 coupled to a gearbox. A connector 141 supplies power to the motor 140 according to a motor operation command.

[0060] The gearbox is connected to gear 18 which in turn is connected to drive screw 17 to transfer torque and rotation from the shaft of motor 140 to drive screw 17. Thus, the drive system includes a nut which is connected to the drive screw and is rotatably movable about the axis of the screw on a double-acting spherical stop under the driving action of actuator 14, the nut being connected to the screw such that rotation of the nut drives the screw translationally only in the direction of movement of the movable part.

[0061] Rotation of screw 17 then drives the nut translationally, causing movable wall 130 to translate in a direction parallel to the axis of the screw (i.e., in the direction of the longitudinal axis). The direction of movement of movable wall 130 depends on the direction of rotation of motor 140.

[0062] Gear 18 is received in block 15 by means of ball bearing 16 which enables the gear to rotate in block 15.

[0063] Of course, Figure 1 Only one embodiment of the medical device is shown by way of illustration and those skilled in the art can define any other arrangement of the variable volume reservoir and actuator to perform the functions of the medical device.

[0064] This device is different from an artificial sphincter which includes a pump, a pressure regulating balloon and a cuff which can be manually operated by a patient, as the device has a controllable autonomous operation without the need for the patient to repeat manual actions.

[0065] In other applications, the medical device can be an artificial muscle, an electrical stimulator, a gastric band, a nerve stimulator or a penile implant (non-limiting list).

[0066] Between the manufacturing site of the medical device and the operating room where the medical device is implanted into a patient, the medical device is arranged in a package which is the subject of this document. The package is adapted to keep the medical device in a sterile state by protecting it from external contamination and to protect the medical device from shock. In the package, the medical device does not contain biocompatible fluid and the fluid circuit is only filled in the operating room.

[0067] As described below, the package is also adapted to enable the fluid circuit to be emptied without the need for a physician in the operating room to operate on the medical device.

[0068] The package first includes a reservoir in which the medical device is held in a so-called vertical position, i.e., the reservoir is positioned between the bottom of the reservoir and the fluid outlet.

[0069] The reservoir includes a horizontal bottom, side walls, and an upper surface opposite the bottom in the vertical direction.

[0070] The reservoir includes at least one opening configured to allow the reservoir to be filled with a biocompatible fluid.

[0071] The fluid outlet of the medical device is located below the opening such that when the reservoir is filled, the entire medical device including the fluid outlet is immersed in the fluid.

[0072] To ensure that filling the reservoir with the biocompatible fluid is sufficient to implement the evacuation method, the reservoir may advantageously include a visual water level indicator provided in the top portion of the reservoir. Advantageously, the volume of the reservoir and the position of the indicator have been selected and its dimensions determined such that the reservoir of the device can be filled. Alternatively, the reservoir may include a cavity in the upper portion intended to receive the overflow of the biocompatible fluid to regulate the overflow of the fluid and avoid overfilling.

[0073] The medical device is held in a vertical position by a first holding element disposed on the bottom, sidewall, and / or upper surface of the reservoir.

[0074] According to one embodiment, the first holding element is in the form of a receptacle sized to receive a portion of the housing by applying a slight clamping action to hold the housing in the desired position without damaging the housing.

[0075] Advantageously, the receptacle is disposed at the bottom of the reservoir.

[0076] According to a preferred embodiment, the reservoir is manufactured, for example, by molding or shaping a plastic material, and the receptacle is integrated into the bottom of the reservoir by molding or shaping. For example, the receptacle may be in the form of two parallel partitions spaced apart by the width of the housing.

[0077] In some embodiments, the medical device may be packaged with a pipe fluidly connected to the fluid outlet. In this case, the housing advantageously includes a second holding element disposed on the bottom and / or sidewall of the reservoir to hold a portion of the pipe below the fluid outlet.

[0078] Advantageously, the second holding element is in the form of a receptacle disposed at the bottom of the reservoir, parallel to the housing receptacle. For example, the receptacle may be in the form of two parallel partitions spaced apart by the diameter of the pipe.

[0079] According to a suitable embodiment shown in the figures, the reservoir has a parallelepiped shape including four sidewalls and a bottom, with one side opposite the bottom being open. However, this particular shape is by no means restrictive.

[0080] Thus, according to other embodiments not shown, the reservoir may have any other shape, for example, cylindrical, for example, having a cylindrical sidewall and a circular bottom.

[0081] Particularly advantageously, the bottom of the reservoir has substantially the same dimensions in two orthogonal directions in the horizontal plane to ensure the stability of the reservoir, in particular to avoid any tipping of the reservoir when emptying the medical device.

[0082] According to some embodiments not shown, the opening of the reservoir may not be located on the upper surface of the reservoir, but on the side wall of the reservoir, preferably in the upper part of said wall, and thus above the fluid outlet of the medical device.

[0083] In any case, the dimensions and the opening of the reservoir are arranged such that when the bottom of the reservoir extends in the horizontal plane, the reservoir can be filled with a biocompatible fluid, at least up to the height of the fluid outlet of the medical device, preferably above said outlet. Thus, during emptying, the entire fluid circuit extending between the storage part and the fluid outlet can be filled with a biocompatible fluid and the initially present air can be emptied. In particular, by varying the volume of the storage part, filling and emptying can be carried out through said fluid outlet without any user intervention other than activating the volume change, thus avoiding any contamination.

[0084] Advantageously, the packaging further comprises a lid removable from the reservoir to at least partially block the opening. For example, the lid is preferably snap - fitted onto the side wall and is held on said side wall by friction or snap - fitting.

[0085] According to a preferred embodiment, the lid is configured to be fixed only to a part of the side wall, and the lid has at least one gripping zone spaced from the side wall. For example, the lid may have a profile having a part that conforms to the shape of the opening defined by the side wall and a part that is recessed from the side wall to form a passage for the physician's finger, thus facilitating gripping of the lid.

[0086] Particularly advantageously, the lid has another holding element adapted to hold the medical device in a vertical position. This holding element may be in the form of a receptacle arranged facing the receptacle formed in the reservoir. Thus, the medical device is held in a vertical position at two locations, which improves the stability of the medical device, especially during transportation.

[0087] Just like the reservoir, the lid can be made by molding or shaping a plastic material, and the receptacle is integrated inside the lid by molding or shaping. For example, the receptacle may be in the form of two parallel partitions spaced apart by the width of the housing.

[0088] In some embodiments, the packaging includes a barrel for receiving the reservoir. The barrel provides additional protection for the medical device against impact. Advantageously, the barrel also forms a sterile enclosure for the reservoir, thereby enhancing the protection of the medical device against external contaminants. Preferably, during the implantation process, the barrel can be operated and opened outside the sterile room of the operating theater, so that the reservoir can be removed from the barrel and placed in the sterile room. Then, the physician opens and operates the reservoir in the sterile room. In addition, as described below, the barrel can be used in the evacuation method by filling it with a biocompatible fluid.

[0089] A method for packaging a medical device can be implemented in the following manner, wherein the packaging is as Figure 2 shown.

[0090] The assembled medical device 1 is placed in the reservoir 2. For this purpose, the medical device engages in one or more holding elements provided in the reservoir to hold the device, wherein the fluid outlet is located above the reservoir. When the fluid outlet is connected to a pipe, the pipe is preferably also engaged in one or more holding elements provided in the reservoir to hold the pipe at the bottom of the reservoir.

[0091] Referring to Figure 3 , the reservoir 2 includes a bottom 20 and side walls 21 extending substantially vertically from the bottom 20. On the side opposite to the bottom 20, the side walls 21 have an edge 22 extending outwardly in the horizontal plane. The edge 22 defines the upper surface of the reservoir provided with an opening 24.

[0092] As described above with reference to Figure 1 , the medical device 1 includes a housing 11 in which a biocompatible fluid storage portion 13 (shown in dashed lines in Figure 4 ) is arranged. The medical device 1 also includes a fluid outlet 12 that is connected to the housing 11 and is in fluid connection with the storage portion 13. The fluid outlet 12 provides a fluid connection between the storage portion and the outside of the housing. The fluid outlet 12 is connected to a pipe 10 that is intended to be connected to an occlusion cuff during the implantation process.

[0093] The height of the side walls 21 is greater than the height of the medical device in its vertical packaging position. Thus, as Figure 4 and Figure 5 shown, when the medical device 1 is arranged in the reservoir 2, the medical device is completely accommodated within the reservoir 2. The fluid outlet 12 is arranged below the opening 24 such that when the reservoir is filled, the fluid outlet can be covered by the fluid. When the medical device is arranged in the reservoir, the storage portion 13 is arranged below the fluid outlet 12.

[0094] The bottom 20 has a substantially square shape to ensure the stability of the reservoir.

[0095] The bottom 20 of the reservoir 2 includes a receiving portion 201 adapted to hold the medical device in a vertical position. The receiving portion 201 is defined as a cavity formed in the bottom 20, parallel to one of the sides, and extending substantially between the middle of one side of the bottom 20 and the middle of the opposite side. The position of the receiving portion is in the central region of the bottom to ensure the stability of the reservoir-medical device assembly when the medical device is disposed in the receiving portion and the reservoir is filled with a biocompatible fluid. The width of the receiving portion is substantially equal to the width of the medical device, such that the medical device can be inserted and held in the receiving portion. The depth of the receiving portion is selected to avoid any tipping of the housing 11; a depth of 5 to 15 mm is suitable for this function.

[0096] Advantageously, the receiving portion 201 is provided with two pairs of circular protrusions (not shown), wherein each pair of protrusions is arranged opposite to each other in the width direction of the receiving portion 201. Each pair of protrusions locally limits the width of the receiving portion 201, thereby exerting a slight clamping action on the medical device to hold the medical device in place.

[0097] The bottom 20 of the reservoir also includes a receiving portion 203 for the conduit 10 of the medical device. The width of the receiving portion is substantially equal to the diameter of the conduit. The housing is in the form of two parallel studs 204 protruding relative to the bottom 20. Advantageously, for the receiving portion 201, the stud has a pair of circular protrusions (not shown) facing each other in the width direction of the receiving portion 203. The pair of protrusions locally limits the width of the receiving portion 203, thereby exerting a slight clamping action on the conduit. Advantageously, the receiving portion 203 is parallel to the receiving portion 201.

[0098] Alternatively, the receiving portion 201 can be defined by one or more pairs of studs facing each other, which protrude relative to the bottom of the reservoir. The receiving portion 203 can be defined as a cavity in the bottom of the reservoir. Any other shape suitable for holding the medical device in a vertical position can be used.

[0099] The lid 3 is placed on the reservoir 2. Then, the medical device is engaged in one or more holding elements provided in the lid to hold the device, wherein the fluid outlet is located above the reservoir.

[0100] For example, the lid can include a receiving portion 30 formed in the lid facing the receiving portion 201. The receiving portion 30 can be defined by two protruding studs relative to the inner surface of the lid, or be defined as a hollow portion formed in the inner surface of the lid. The width of the receiving portion 30 is substantially equal to the width of the upper portion of the medical device 1 in the vertical position.

[0101] Advantageously, the lid 3 is substantially cross-shaped. Thus, the lid only blocks a part of the upper opening of the reservoir 2 and leaves openings at the corners of the reservoir, which openings are adapted for the physician to grip the lid in the gripping area 31.

[0102] The corresponding shapes and dimensions of the side wall 21 and the edge of the lid 3 are selected such that the lid can be snap-fitted into the reservoir. In particular, the side wall 21 may include a flange 25 in its upper part, which flange is adapted to hold the corresponding edge of the lid 3.

[0103] Then, a first sheet 4 permeable to the sterilizing gas (e.g., a seal made of TyvekTM) is sealed to the upper edge 22 of the reservoir.

[0104] Then the reservoir 2 is placed in the bucket part 5.

[0105] The bucket part 5 has a shape similar to that of the reservoir 2, but is larger in size. Preferably, the bucket part 5 has sufficient dimensions to completely receive the reservoir 2 while minimizing the free space between the reservoir 2 and the bucket part 5, so as to minimize the overall size of the package.

[0106] The bucket part 5 has a substantially flat bottom 50 and side walls extending substantially vertically from the bottom 50. On the side opposite to the bottom 50, the side wall 51 has an edge 52 extending outwardly in the horizontal plane. The edge 52 defines the upper surface of the bucket part provided with a central opening.

[0107] Advantageously, the bucket part 5 has an inner flange 53 to provide support for the flange 22 of the reservoir 2.

[0108] Just like the bottom 20 of the reservoir, the bottom 50 of the bucket part 5 is substantially square to ensure good stability of the bucket part.

[0109] Then, a second sheet 6 permeable to the sterilizing gas (e.g., a seal made of TyvekTM) is sealed to the upper edge 52 of the bucket part 5.

[0110] The package sealed in this way is sterilized by any suitable means and then packaged in a box (not shown) constituting an outer shell, in which the medical device is delivered to the physician for implantation into the patient's body.

[0111] For such implantation, the physician takes out the package from the box, removes the second sealing sheet, takes out the reservoir, and then removes the first sealing sheet.

[0112] According to one embodiment, the physician takes out the reservoir from the bucket part to fill the reservoir with a biocompatible fluid.

[0113] For such filling and emptying, the physician must ensure that the bottom of the reservoir is horizontal.

[0114] The levelness of the bottom of the reservoir can be ensured by placing the bottom of the reservoir on a flat horizontal surface (e.g., on a table).

[0115] This levelness can be confirmed by means of a suitable indicator. For example, such a level indicator can be an indicator of the level of the water in the reservoir. For example, such an indicator can be in the form of one or more sections formed (e.g., directly by molding or even by printing) in the reservoir and placed in the upper part of the reservoir in a manner parallel to the bottom. Such an indicator can also serve as a filling indicator for the physician, indicating to him or her the height to which the biocompatible fluid should be poured into the reservoir to achieve effective emptying. Figure 3 An embodiment of such a level indicator is shown, which is in the form of a hollow or raised internal line 23 extending in a horizontal plane within the side wall 21. Preferably, the internal line 23 extends continuously or discontinuously on a plurality of sides of the side wall 21.

[0116] The medical device itself can also provide an indication of the levelness of the bottom of the reservoir. In fact, the device generally includes an accelerometer arranged in the housing, which can be used to determine the patient's posture or activity when the medical device is implanted. Since the housing is integral with the bottom of the reservoir in a defined orientation (usually vertical) relative to the bottom of the reservoir, the accelerometer can provide an indication of the inclination of the bottom of the reservoir.

[0117] Alternatively or additionally, this levelness can be ensured by placing the reservoir in a container filled with fluid. In this case, the reservoir is sized such that when the medical device is held in the position intended for emptying, the reservoir floats in the container while keeping the fluid outlet of the medical device above the reservoir.

[0118] For this purpose, the bucket part in which the reservoir is arranged in the packaging can be used as the container.

[0119] Then, the physician fills the reservoir with the biocompatible fluid for the operation of the medical device. The fluid can be, for example, saline.

[0120] Then, the physician activates the actuator of the medical device to expel the air present in the fluid circuit extending between the storage part and the fluid outlet and make it enter the pipeline (if any), and fill the fluid circuit and the pipeline with the biocompatible fluid. The actuator can be activated multiple times (e.g., three times) such that the movable wall of the storage part moves to change the volume of the storage part, thereby exerting a pumping action until the fluid circuit is completely emptied (no bubbles escape from the fluid outlet).

[0121] This activation of the actuator does not require any manipulation of the medical device itself. In fact, the medical device includes a wireless communication device with an external remote control, which enables the device to be parameterized and activation or deactivation commands to be sent to it.

[0122] Once the evacuation is complete, the physician can block the end of the fluid outlet or the pipe (if any) and remove the medical device from the reservoir for the implantation procedure.

[0123] Thus, the physician has no contact with the medical device prior to implantation, thereby avoiding or at least minimizing the risk of device contamination.

[0124] In addition, no physician intervention is required during evacuation. In fact, once evacuation begins, the actuator of the device sucks in the biocompatible fluid and expels the air. This enables the physician to focus on other tasks, such as preparation for implantation. Thus, the surgical time can be significantly reduced.

[0125] Finally, the fact that the evacuation process is automatic increases the reliability of the method.

[0126] It should be understood that the above embodiments are specific and non - limiting examples, and various modifications can be made without departing from the present invention.

Claims

1. A component of a medical device (1) and a package adapted for implantation into a human or animal body, wherein: - The medical device includes a housing (11) and a fluid outlet (12), the housing enclosing a fluid storage portion (13), and the fluid outlet forms a fluid connection between the fluid storage portion and a volume outside the housing. - The package includes a reservoir (2), the reservoir including a bottom (20), side walls (21), and an upper surface opposite the bottom in the vertical direction. The bottom of the reservoir (20) extends in a horizontal plane perpendicular to the vertical direction, and at least one of the bottom, the side walls, and the upper surface includes a first retaining element (201) adapted to hold the housing in the reservoir. The reservoir further includes an opening configured to fill the reservoir with a biocompatible fluid to fill a fluid circuit that extends from the fluid outlet to the fluid storage portion of the medical device. The housing (11) is held in the reservoir (2) by the first retaining element (201) such that the fluid storage portion is positioned between the bottom of the reservoir and the fluid outlet, enabling the fluid circuit to be emptied without operating the medical device. The fluid outlet is arranged below the opening such that when the reservoir is filled with the biocompatible fluid, the fluid outlet is immersed in the fluid.

2. The component according to claim 1, wherein, the medical device (1) includes a conduit (10) fluidly connected to the fluid outlet (12), and the bottom and / or side walls of the reservoir include a second retaining element (203) adapted to hold a portion of the conduit.

3. The component according to claim 1 or 2, wherein, the opening is arranged on the upper surface of the reservoir.

4. The component according to claim 1 or 2, wherein, the opening is arranged in an upper portion of the side wall.

5. The component according to claim 2, wherein, the component further includes a lid (3) that can be removed from the reservoir (2) to at least partially block the opening.

6. The component according to claim 5, wherein, the lid (3) is configured to be fixed only to a portion of at least one side wall (21), and the lid (3) has at least one gripping area (31) away from the at least one side wall.

7. The component according to claim 5 or 6, wherein, the lid (3) further has a third retaining element (30) adapted to hold the housing in the position in the reservoir between the bottom of the reservoir and the fluid outlet.

8. The component according to claim 7, wherein, each retaining element (201, 203, 30) is a receiving portion adapted to hold the housing (11) and / or the conduit (10) by friction.

9. The component according to claim 8, wherein, the reservoir (2) is formed by molding a plastic material, and each receiving portion is molded as an integral part.

10. The component according to claim 1 or 2, wherein, The storage tank (2) includes a level indicator at the bottom of the storage tank.

11. The assembly according to claim 10, wherein, the level indicator at the bottom of the storage tank is a level indicator (23) of the liquid level in the storage tank.

12. The assembly according to claim 1 or 2, wherein, the assembly further includes a barrel portion (5) adapted to receive the storage tank (2).

13. The assembly according to claim 1 or 2, wherein, the assembly further includes a first seal (4) permeable to the sterilizing gas, the first seal being integral with at least one side wall (21), and the storage tank (2) and the first seal (4) together form a sterile enclosure for the medical device (1).

14. The assembly according to claim 13, wherein, the assembly further includes a barrel portion (5) adapted to receive the storage tank (2), the assembly further includes a second seal (6) permeable to the sterilizing gas, the second seal plugging the barrel portion (5), and the barrel portion (5) and the second seal (6) together form a sterile enclosure for the storage tank (2).

15. The assembly according to claim 1 or 2, wherein, the fluid storage portion (13) includes a fixed wall and a movable wall (130) movable relative to the fixed wall to change the volume of the fluid storage portion, and the change in the volume of the fluid storage portion is adapted to fill the biocompatible fluid and empty the fluid circuit.

16. The assembly according to claim 15, wherein, the medical device (1) includes an electromechanical actuator (14) disposed in the housing, the electromechanical actuator being configured to move the movable wall (130) of the fluid storage portion to change the volume of the fluid storage portion.

17. The assembly according to claim 1 or 2, wherein, the housing (11) includes a single fluid outlet (12) and a single fluid connection between the fluid storage portion (13) and the fluid outlet (12).

18. The assembly according to claim 1 or 2, wherein, the medical device (1) is selected from the group consisting of an artificial sphincter, an artificial muscle, an electrical stimulator, a gastric band, a nerve stimulator, and a penile implant.

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