Method for ejecting a medical device adapted to be implanted - Patent application

Abstract

The present invention relates to a method for evacuating a medical device (1) implanted in the human or animal body, the medical device comprising a housing (11) enclosing a fluid reservoir (13) and a fluid outlet (12) forming a fluid connection between the fluid reservoir and a volume outside the housing, the method comprising providing the medical device in packaging comprising a tank (2), the housing being held in the tank in a position where the fluid reservoir is located between the bottom of the tank and the fluid outlet, filling the tank (2) with a biocompatible fluid such that a zone of the packaging located outside the medical device and in fluid connection with the fluid outlet of the tank is immersed in the fluid, and evacuating the medical device and filling the fluid reservoir (13) with the biocompatible fluid.

Description

[Technical field]

[0001] The present invention relates to packaging for medical devices adapted (configured) to be implanted (implanted) within the human or animal body that contain a fluid reservoir. [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 method of draining (emptying) a medical device adapted (configured) to be implanted that contains a fluid reservoir that does not require handling of the device. [Means for solving the problem]

[0011] To this end, a first object of the invention relates to a method for draining a medical device adapted to be implanted in a human or animal body, the medical device comprising 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 method comprising the steps of: - providing a medical device in a packaging including a tank, the casing being held within the tank in a position such that the fluid reservoir is located between a bottom of the tank and a fluid outlet; - filling the tank with a biocompatible fluid such that a zone of the packaging external to the medical device that is in fluid communication with a fluid outlet of the fluid reservoir is immersed in the fluid; - filling the fluid reservoir with a biocompatible fluid and draining the medical device by discharging any air present in the fluid reservoir to the fluid outlet.

[0012] Preferably, the biocompatible fluid may be a liquid.

[0013] The method may include the step of checking the levelness of the bottom of the tank.

[0014] According to one embodiment, the checking is based on a levelness indicator of the fluid level in the tank.

[0015] According to another embodiment, possibly in combination with the above, the checking of levelness is performed using an accelerometer of the medical device.

[0016] Alternatively or additionally to the two preceding embodiments, the tank is immersed in a container filled with fluid in order to obtain a levelness of the bottom of the tank.

[0017] In some embodiments, draining (emptying) the medical device is performed by moving a movable wall of the tank to change the volume of the fluid reservoir.

[0018] Movement of the movable wall of the fluid reservoir may be effected by an electromechanical actuator disposed within the casing.

[0019] In some embodiments, the casing includes a single fluid outlet and a single fluid connection between the fluid reservoir and the fluid outlet.

[0020] In some embodiments, the medical device is adapted to control obstruction of a natural duct in the human or animal body.

[0021] 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.

[0022] 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]

[0023] [Figure 1] FIG. 2 is an exploded view of packaging according to one embodiment. [Diagram 2] FIG. [Diagram 3] FIG. 2 is a cross-sectional view of the assembled packaging of FIG. 1. [Figure 4] FIG. 1 is a perspective view of a medical device in its packaging. [Diagram 5] FIG. 2 is a block diagram of an ejection method according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0024] The medical device includes a casing made of a biocompatible material, such as titanium.

[0025] The casing contains a reservoir of biocompatible fluid and comprises a fluid outlet forming a fluid connection between the reservoir and an environment external to the medical device, said fluid outlet may in particular be connected to tubing providing a fluid connection with an element external to the casing.

[0026] According to one embodiment, the reservoir comprises a movable wall driven by an actuator, the movement of which allows the volume of the reservoir to be changed in a controlled manner, this volume variation allowing fluid to be transferred from the reservoir to the fluid outlet or from the fluid outlet to the reservoir.

[0027] Particularly advantageously, the actuator is an electromechanical actuator, which is controlled by a control unit to move the movable wall a determined distance. The control unit can be located within the casing. Thus, the medical device is autonomous in that it does not require any action by the medical practitioner to perform its functions.

[0028] Additionally, the device advantageously includes a single fluid outlet and a single fluid circuit between the reservoir and the fluid outlet.

[0029] In some applications, the medical device is an artificial sphincter for selectively closing an anatomical duct by exerting a compressive force on the anatomical duct. In particular, the medical device may be an artificial urinary sphincter.

[0030] 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.

[0031] An example of such a medical device is described in US Pat. No. 5,399,633.

[0032] 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.

[0033] 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).

[0034] 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 packaging 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, and filling of the fluid circuits is carried out only in the operating room.

[0035] 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.

[0036] The packaging firstly comprises a tank, in which the medical device is held in a so-called vertical position, i.e. the reservoir is located between the bottom of the tank and the fluid outlet.

[0037] The tank includes a horizontal bottom, sidewalls, and a top surface vertically opposite the bottom.

[0038] The reservoir includes at least one opening configured to allow the reservoir to be filled with a biocompatible fluid.

[0039] 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.

[0040] To ensure that filling the reservoir with biocompatible fluid is sufficient to perform the drainage method, the reservoir may advantageously include a visual liquid level indicator located at the top of the reservoir. Advantageously, the reservoir volume and the location of the indicator are selected and dimensioned to allow filling of the device reservoir.

[0041] Alternatively, to accommodate overflow of the fluid and avoid overfilling, the reservoir can include a cavity at the top to receive the overflow of the biocompatible fluid.

[0042] 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.

[0043] 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.

[0044] Advantageously, said housing is arranged at the bottom of the tank.

[0045] According to a preferred exemplary 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.

[0046] In some embodiments, the medical device may be packaged with tubing in fluid connection with the fluid outlet, in which case the reservoir advantageously includes a second retention element disposed on the bottom and / or sidewall of the reservoir for retaining a portion of the tubing below the fluid outlet.

[0047] 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.

[0048] 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 face opposite the bottom being open, however, this particular shape is by no means limiting.

[0049] Thus, according to other exemplary 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.

[0050] 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.

[0051] 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.

[0052] In any case, the reservoir is dimensioned and the openings are arranged such 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, so that, 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 expelled.

[0053] 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.

[0054] 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.

[0055] 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.

[0056] 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.

[0057] 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 improving protection of the medical device from external contaminants. Preferably, during the implantation procedure, the tub can be handled and opened outside the sterile field of the operating room so that the reservoir can be extracted from the tub and passed through the sterile field. The reservoir is then opened and handled by the practitioner in the sterile field. Furthermore, as explained below, the tub can be used in an evacuation method by filling it with a biocompatible fluid.

[0058] A method of packaging a medical device can be carried out as follows, using the packaging illustrated in FIG.

[0059] 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 reservoir. 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.

[0060] 2, 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.

[0061] The medical device 1 includes a casing 11 in which a biocompatible fluid reservoir 13 (shown in dotted lines in FIG. 3) 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 which is connected to an occlusion cuff during implantation.

[0062] 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 Fig. 3, 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.

[0063] The bottom 20 has a substantially square shape to ensure the stability of the tank.

[0064] 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.

[0065] Particularly advantageously, the housing 201 comprises two pairs of rounded projections (not shown), each pair of projections arranged facing 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.

[0066] 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.

[0067] 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.

[0068] 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.

[0069] 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.

[0070] Advantageously, the cover 3 is substantially cross-shaped, so that it closes 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.

[0071] The shape and dimensions of each of the edges of the cover 3 and of 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 rim 25 adapted to hold the respective edges of the cover 3.

[0072] Next, a first sheet 4 permeable to sterilizing gas, for example an inner seal made of Tyvek™, is sealed to the upper edge 22 of the tank.

[0073] The tank 2 is then placed in the tub 5 .

[0074] 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.

[0075] 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.

[0076] Advantageously, the tub 5 has an inner rim 53 which provides support for the edge 22 of the tank 2 .

[0077] Like the bottom 20 of the tank, the bottom 50 of the tub 5 is substantially square to ensure good stability of the tub.

[0078] A second sheet 6 that is permeable to sterilizing gases, such as an inner seal made from Tyvek™, is then sealed to the upper edge 52 of the tub 5 .

[0079] The sealed packaging is then sterilized by any suitable means and then packaged within 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.

[0080] 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.

[0081] Generally speaking, the method of ejecting a medical device includes the following steps, the sequence of which is illustrated in FIG. - In step 100, the practitioner places the device in the tank with the casing held within the tank in the vertical position in which it is packaged, as illustrated in Figure 4. Thus, the reservoir is located between the bottom of the tank and the fluid outlet. - In step 200, the practitioner fills the reservoir with a biocompatible fluid, so that a zone of the packaging external to the medical device that is in fluid connection with the fluid outlet of the reservoir is immersed in the fluid. - In step 300, evacuation of the medical device is performed, allowing filling of the reservoir with biocompatible fluid and extraction of any air initially present in the fluid circuit.

[0082] These various steps are described in more detail below.

[0083] According to one embodiment, the practitioner removes the reservoir from the tub in order to fill it with a biocompatible fluid.

[0084] To perform this filling and draining, the practitioner must ensure that the bottom of the tank is level.

[0085] Levelness of the tank bottom can be ensured by placing the bottom of the tank on a flat, horizontal surface, such as a table.

[0086] 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 also serves as a filling indicator for the practitioner, showing him how high the biocompatible fluid should be poured into the tank to allow effective drainage. Figure 2 illustrates an embodiment of such a levelness indicator in the form of a hollow or raised internal line 23 extending in a horizontal plane on the inside of the side wall 21. Preferably, said internal line 23 extends continuously or discontinuously on several sides of the side wall 21.

[0087] 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.

[0088] 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 keeping the fluid outlet of the medical device above the tank.

[0089] The tub in which the tank is placed within the packaging may be used as a container for this purpose.

[0090] 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.

[0091] 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).

[0092] 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.

[0093] 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.

[0094] 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.

[0095] 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.

[0096] Finally, the fact that the ejection process is automatic increases the reliability of the method.

[0097] 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]

[0098] [Patent Document 1] International Publication No. WO2016 / 083428

Claims

1. 1. A method for evacuating air from a medical device adapted to be implanted in a human or animal body, comprising: 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 method comprising: providing the medical device in a packaging including a tank, the casing being held within the tank in a position such that the fluid reservoir is located between a bottom of the tank and the fluid outlet; - filling the tank with a biocompatible fluid such that a zone of the packaging external to the medical device that is in fluid connection with the fluid outlet of the fluid reservoir is immersed in the biocompatible fluid; - filling the fluid reservoir with the biocompatible fluid and expelling air present in the fluid reservoir to the fluid outlet, thereby evacuating air from the medical device, method.

2. The method of claim 1 , further comprising checking the levelness of the bottom of the tank.

3. The method of claim 2 , wherein the checking is based on a levelness indicator of a fluid level in the tank.

4. The method of claim 2 or 3, wherein the checking of levelness is performed using an accelerometer of the medical device.

5. The method according to any one of claims 2 to 4, wherein the tank is immersed in a vessel filled with a fluid to obtain a levelness of the bottom of the tank.

6. The method according to any one of claims 1 to 5, wherein expelling air from the medical device is performed by moving a movable wall of the tank to change the volume of the fluid reservoir.

7. The method of claim 6 , wherein the movement of the movable wall of the fluid reservoir is effected by an electromechanical actuator disposed within the casing.

8. A method 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.

9. The method according to any one of claims 1 to 8, wherein the medical device is adapted to control the obstruction of a natural duct in the human or animal body.

10. 10. The method of any one of claims 1 to 9, wherein 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.

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