Vaginal ring device with Bluetooth connection function

Abstract

The present disclosure provides a vaginal drug delivery and / or sensor device comprising a drug delivery unit and / or a sensing unit and a flexible circuit board comprising a first region and a second region, preferably connected via a curved region. The control circuitry is disposed on the first region of the FPCB. The wireless communication module is disposed on the FPCB, and a slot antenna is formed on the second region of the FPCB by providing a slot in a metal layer disposed on the second region. The microstrip line connects the wireless communication module to a connection point at or adjacent to the first end of the slot. A ceramic buffer is disposed over the slot antenna on the second region. At least one adhesive layer is disposed between the ceramic buffer and the slot antenna on the second region.

Description

[0001] The present invention relates to a vaginal ring, such as a vaginal drug delivery device and / or a diagnostic device, having wireless communication capabilities, particularly Bluetooth connectivity, while positioned in the vagina.

[0002] In the context of the present invention, a vaginal drug delivery device is a device configured to deliver a drug inside the vagina.Similarly, a vaginal diagnostic device is configured to perform a diagnostic or measurement function inside the vagina.

[0003] Vaginal drug delivery devices are known in the art. For example, the low-dose contraceptive vaginal ring known as Nuvaring® is made of poly(ethylene vinyl acetate). The ring releases hormones to provide contraceptive protection. However, it is worth noting that vaginal drug delivery devices have also been shown to be useful for delivering some other types of drugs due to their ability to release drugs where they can be directly absorbed by the body and their potential for gradual release. As a result, drug absorption can be more rapid, avoiding the first-pass effect in the liver and resulting in higher bioavailability. Vaginal drug delivery devices may also include sensors to control / monitor drug release or for other diagnostic or monitoring functions.

[0004] US 2006 / 0084848 A1 discloses a device for monitoring participants in clinical trials, and methods and systems for its use, that minimize or eliminate the well-known inaccuracies of participant self-reporting. In a preferred embodiment, the device is self-sufficient and self-powered, resides on or in a body cavity of a participant, collects and monitors data on the participant's behavior and medically relevant aspects of the local device environment, and stores the data in on-device memory. An accompanying external station reads the stored data and prepares it for use. The device may include electrically active sensors and non-electrically active sampling sensors. A preferred embodiment of the device is in clinical trials of microbicides for inhibiting HIV transmission.

[0005] Document US 2012 / 0276854 A1 discloses an implantable medical device, which may include a housing for storing components of the implantable medical device. The implantable medical device may include an induction coil coupled to a rechargeable battery. The induction coil is operable to inductively couple to an external coil and transfer energy from the external coil to the rechargeable battery to recharge the rechargeable battery. The implantable medical device may include a cutout formed in the housing of the implantable medical device and filled with a dielectric material. The cutout is operable to reduce eddy currents in the housing during recharging of the rechargeable battery. The implantable medical device may include a slot antenna disposed within the housing. The slot antenna is operable to communicate with an external device through the cutout in the housing.

[0006] Regardless of the intended application, such rings typically have a substantially annular or elliptical shape and are typically configured so that their shape can be temporarily altered for insertion into the vagina, after which the original ring shape is restored and the device is stably positioned at or near the user's uterine vault or cervix. A particularly advantageous example of such prior art is disclosed in EP 3359099 B1.

[0007] In embodiments where the device is a vaginal drug delivery device, the prior art device includes a reservoir for holding a medicament to be delivered, an outlet for dispensing the medicament, and a pump for pumping the medicament out of the outlet. In embodiments where the device is a diagnostic device, the device includes a diagnostic device for performing intravaginal diagnosis or measurement, such as one or more sensors. Combination devices including a reservoir, an outlet, and a pump, as well as one or more sensors, are also disclosed.

[0008] To allow insertion, the device includes two rigid members coupled at one end by a first flexible member acting as a hinge and at the other end by a flexible portion; the first flexible member and / or the flexible portion are configured to allow the device to be squeezed by bringing the other ends together, thereby transforming the shape of the device from an extended shape corresponding to a substantially elliptical or toroidal shape to a contracted shape for allowing the device to be self-inserted into the user's vagina at or near the posterior fornix of the vagina. At least one of the first flexible member and the flexible portion is at least partially elastic, such that when no external force is applied, the device is pre-biased to assume the extended shape.

[0009] It is known, for example from the aforementioned documents, to include a controller in such devices, usually in the form of a printed circuit board (PCB), for controlling the pump and / or the diagnostic device.

[0010] It is also contemplated to include wireless communication means for communicating with such a pessary device, typically via a controller, for example to obtain data collected by diagnostic means in the ring to determine the function of such a device, and / or to send commands to various elements in the pessary device (particularly the pump) to control the delivery of medication. Indeed, the aforementioned document discloses the possibility of including a transmitter and / or receiver, for example by incorporating a transceiver into the device, which can be placed in one of the rigid components.

[0011] However, wireless communication with the vaginal ring presents several significant challenges. The human body is primarily a lossy medium for electromagnetic radiation, with a relatively high dielectric constant. When in use, the vaginal ring is surrounded by body tissue, the thickness of which can be significant, particularly in individuals with high levels of body fat in the vaginal and periuterine areas. Furthermore, one of the most convenient low-energy methods for communicating with a smartphone (or other wireless-capable personal electronic device) is typically Bluetooth®, which has a relatively short range even under ideal conditions. Furthermore, the frequency band used for Bluetooth communication, from 2.402 GHz to 2.48 GHz, is highly sensitive to these effects. Significant signal strength losses are observed when radiating signals to and from a vaginal ring within the body, and maintaining the signal's frequency within the band can also present challenges. Constraints on the size of the vaginal ring, imposed by body size and user comfort, also impose strict limitations on the size of any antenna or antenna array.

[0012] Thus, despite years of considering wireless communication with vaginal ring devices highly desirable, and contrary to claims by some manufacturers, existing vaginal rings incorporating transceivers for wireless communication have not yet been able to achieve reliable, consistent wireless communication with vaginal ring devices inserted into the body in a manner robust to variations in body size, particularly without using Bluetooth signals or other signals within (or near) the Bluetooth frequency band. In fact, some existing devices that claim they can be read while in use (such as temperature sensing devices for fertility monitoring) actually require the user to remove the vaginal ring device each time they wish to read the collected data. This is highly inconvenient, especially for applications where it is desirable to obtain up-to-date measurements at a relatively high frequency. For example, for fertility monitoring, temperature is ideally measured at least once a day; other applications require a higher frequency than this.

[0013] Being able to communicate with the pessary device while it remains inserted would be more user-friendly. In addition to this, many other applications require the possibility of more frequent and direct communication, such as highly time-sensitive diagnostic measurements, emergency orders, etc.

[0014] If such reliable and convenient communication is achieved, it also opens the way to many extremely advantageous advanced applications, including personalized and programmable drug delivery that allows complex schedules and delivery based on biological signals, and even provides new insights by collecting precise and complete data from larger patient populations.

[0015] It is therefore an object of the present invention to provide a pessary device capable of wireless communication, preferably in the Bluetooth band, when inserted into the body, which is reliable, consistent, and robust to changes in body size.

[0016] In accordance with this object, a vaginal drug delivery and / or sensor device is provided, comprising a drug delivery unit and / or a sensing unit, the drug delivery unit comprising a reservoir for holding a drug to be delivered, an outlet, a pump for pumping the drug out of the outlet, and a motor for actuating the pump; the sensing unit comprising one or more sensors.

[0017] Such vaginal devices are typically deformable between an extended shape, which is assumed when little or no external force is applied to the device, and a contracted shape that allows the device to be inserted into the vagina of a user. Here, the central axial axis is a theoretical axis about which the ring can be considered to rotate. Because the extended shape is generally not a perfect torus, this axis can be defined in a variety of ways, but it will have the same orientation as the axis of rotation of the smallest torus containing the device.

[0018] The proposed device also includes a flexible printed circuit board (FPCB), which includes a first area and a second area. The control circuit system is arranged on the first area of ​​the FPCB and is communicatively coupled to the drug delivery unit and / or the sensing unit. A wireless communication module is also arranged on the FPCB, preferably configured for Bluetooth communication, and the wireless communication module is communicatively coupled to the control circuit system. The wireless communication module can be arranged on the first area, the second area or another area of ​​the FPCB. A slot antenna is formed on the second area of ​​the FPCB by providing a slot in a metal layer arranged on the second area. A microstrip line connects the wireless communication module to a connection point located at the first end of the slot or adjacent to the first end of the slot. A ceramic buffer is arranged above the slot antenna on the second area, and at least one adhesive layer is arranged between the ceramic buffer and the slot antenna on the second area.

[0019] It has been found that through the combination of these features, a desired signal strength can be achieved within the Bluetooth band.

[0020] Note that while this application focuses on Bluetooth, the proposed device is not limited to the wireless communication module being a Bluetooth module. Specifically, it is worth noting that wireless LAN communication / Wi-Fi (i.e., based on the IEEE 802.11 series of standards) can also operate in the 2.4 GHz band (although it may require more power). Therefore, the solutions proposed in this disclosure can also be used to connect a device to a local area network and / or communicate directly with another device using peer-to-peer WLAN communication.

[0021] In general, it is advantageous for the slot to be as long as possible, in particular longer than the second region, while radiating a signal within the desired frequency range. To this end, the slot preferably has a first end and a second end, and extends along a path between the first end and the second end, such that the total length of the slot is significantly greater than the shortest distance between the first and second end points.

[0022] Specifically, while some previous devices that include control circuitry and antennas have been considered, efficiently arranging these components within the limited available space can be difficult, particularly in devices that include drug delivery units. It is often impossible to arrange all necessary electronics on a rigid printed circuit board within the available space. While it is possible to provide the control circuitry, wireless communication module, and (slot) antenna separately and connect them in various ways, such connections are fragile and often have a detrimental impact on signal strength and performance. Therefore, flexible printed circuit boards (FPCBs) are advantageous, enabling various electronic components (and particularly antennas) to be provided on a single PCB while still maintaining a compact layout. Preferably, the first and second regions of the FPCB are connected via at least one curved region, enabling different orientations and / or arrangements of the two regions. In many embodiments, the first region supporting the control electronics will be substantially planar and will be arranged at an angle to at least a portion of the second region 11, which may also be substantially planar but does not necessarily need to be. For example, by arranging the first and second regions substantially perpendicularly, they can be arranged in line with a section of the device's outer wall while leaving space for other components.

[0023] In this way, various competing constraints can be met: the curved arrangement of the FPCB makes it possible to increase the available area for the control circuitry and antenna, as well as other electronic components such as the wireless connectivity module, while still arranging the various components close to each other within the limited space of the housing. Furthermore, because the first and second regions are connected via at least one curved region, the length of the required connecting elements, most importantly the length of the microstrip line, can be minimized to minimize losses between the communications module and the antenna. Since this connection can be arranged on the FPCB, the resulting arrangement is also more robust.

[0024] The motor tends to be one of the larger elements that needs to be accommodated in the housing, and in an advantageous embodiment comprising a drug delivery unit (and therefore comprising a motor), the motor is at least partially arranged in a space defined by a first area of ​​the FPCB and a second area of ​​the FPCB, or in other words: the FPCB is arranged around (the central axis of) the motor, and since the FPCB uses the space between the motor and corresponding parts of the housing, the FPCB is advantageously compact.

[0025] The specific orientation of the first and second regions involves various considerations. To achieve the desired directionality, it may be advantageous to position the second region (i.e., the antenna region) closest to the inner circumference of the ring. This is because, once positioned, the portion of the ring containing the various electronic components and generally thicker is positioned further toward the user's back. Therefore, an antenna positioned closer to the inner circumference will radiate in a generally forward direction, toward the user's pelvic area. The first region, then, would be positioned closer to the top or bottom of the ring, where "top" and "bottom" are the portions that will be oriented substantially upward and downward, respectively, during use. From a purely antenna perspective, such an arrangement may be preferable. However, the inner circumference of the ring may not be usable, particularly given the limited options for arranging rigid longitudinal components such as motors.

[0026] It has been found that suitable directionality can be achieved even when the second region, and therefore the antenna, is arranged in a plane substantially perpendicular to the central axial axis, particularly in combination with the proposed ceramic buffer and adhesive layer, and in combination with the use of an FPCB. Specifically, it has been found that arranging the second region so that it is on the "top" side of the device, i.e., on the side that is oriented generally upward, when the device is in use, can achieve adequate connection with phones located at various locations around the body. Note that since vaginal rings are generally symmetrical about a plane including the central axis and can therefore be inserted with either side facing upward, it may be useful to add a visual indication on the outside of the ring to clarify to the user what the preferred orientation is.

[0027] In embodiments where the first and second regions are substantially planar, the first region is typically oriented substantially along a portion of the outer circumference of the device. Preferably, for both compactness and performance reasons, the control circuitry and communications module are arranged on the side of the first region of the FPCB that is closest to the outer surface of the device. In other words, in embodiments where the FPCB is arranged around the motor, the surface of the first region of the FPCB on which the various electronic components are arranged faces away from the motor.

[0028] The slot antenna can be positioned on the side of the FPCB that faces the ceramic buffer. In other words, in embodiments where the FPCB is positioned around the motor, the surface with the slot antenna will face away from the motor. In cases where the second region is substantially planar, the radiation characteristics are found to be very similar on both sides of the plane, and thus the slot antenna can also be positioned away from the ceramic buffer, and thus, towards the motor in embodiments where the FPCB is positioned away from the motor. A potential advantage of this approach is that there is no direct contact between the metal coating and the at least one adhesive layer, which can increase the freedom in choosing the adhesive material; however, this can also be a disadvantage in certain situations.

[0029] The second area can take the form of a side flap of the FPCB. The first area, which will typically be larger than the second area, is therefore the "primary" area of ​​the FPCB. The advantage is that the FPCB can then be manufactured flat, with the side flaps on which the slot antennas are formed being bent to accommodate the FPCB in the housing.

[0030] However, as discussed above, the second region in particular does not need to be planar, and embodiments are envisaged in which the second region is curved according to the outer wall of the device.

[0031] Note that in actual applications, the FPCB will likely include more than two areas, which can have various relative orientations, for example to improve connection to the device's battery, to the motor and / or pump and / or to any sensors that may be present. For example, if the second area takes the form of a side wing of the FPCB, the FPCB may also include a second side wing that includes terminals for the battery / power supply. The side wing can then be bent so that it is arranged perpendicular to both the first and second areas. Alternatively or in addition, a side wing can be provided that provides the communication coupling required between the control circuit system and the motor. Additional electronic device components can also be provided and can be arranged in the first area, the second area, or any potential additional area.

[0032] The use of slot antennas makes it possible to arrange the relatively long antennas required for Bluetooth frequencies in very limited space. Generally, the metal layer is a copper and gold coating or other suitable metal coating applied to the second region. Specifically, it has been found advantageous to use a slot antenna having a single, continuous slot that follows a meandering, zigzagging, or otherwise twisted and / or three-dimensional path between its first and second endpoints, such that the total length of the slot can be (much) longer than the shortest distance between these two points. Such antennas are magnetic antennas with a reduced electric component in the near field.

[0033] However, examples with two or more separate slots are not excluded. Using a multi-slot antenna can increase signal quality and is also compatible with multiple-input, multiple-output (MIMO) applications. These slots can all be arranged on the same area of ​​the FPCB, but they can also be arranged across multiple areas. Note that if they are distributed across more than one area, more than one ceramic buffer may be required, and therefore at least one additional adhesive layer may also be required. For example, one disadvantage of having a single, continuous slot is that it will radiate signals with a certain polarity. Therefore, for some phones (or other devices with Bluetooth connectivity), connectivity with the phone may depend on the relative orientation of the phone (and the Bluetooth antenna in it). This can be avoided by providing two slots arranged so that they radiate signals with mutually orthogonal polarities. On the other hand, such a solution requires more space, which may not be available.

[0034] In order to radiate in the correct frequency band, the radiating length of the slot, i.e. the total length of the path starting from the connection point, should be an integer multiple of half a wavelength, i.e. nλ / 2; as with other types of antennas, integer fractions such as λ / 4 or 5 / 4λ are also considered.

[0035] In one embodiment, the second region is substantially rectangular with two shorter sides and two longer sides, with the first end of the slot located adjacent to one of the shorter sides and the second end of the slot located adjacent to the other of the shorter sides. The second region can then be connected to the first region along at least a portion of the first of the longer sides; however, it is also contemplated that the second region can be oriented so that one of the shorter sides runs along a side of the first region. For example, two or three bridging portions can be provided. The second region can also be connected to the first region along the entirety of one of its longer sides, but this is generally not necessary and may add unnecessary bulk. In such a rectangular second region, the slot preferably follows a serpentine path comprising: a longer segment extending substantially parallel to the width of the second region; and a shorter segment extending substantially parallel to the length of the second region, connecting one of the ends of the adjacent longer segments. This generally allows for the longest possible path despite the limited area. However, alternatives are certainly contemplated, such as having only a few, but longer, meanders; using paths along more than two directions, turning at non-right angles, and even curved path segments. In general, in order to avoid potential irregularities, for example due to interference, it is recommended - regardless of the specific shape and size of the path - to keep the distance between adjacent parts of the path comparable to or greater than the width of the slot itself. In the specific case mentioned above, this corresponds to making the distance between two adjacent longer sections at least as great as the width of the slot.

[0036] As described above, the microstrip line connects the wireless communication module to a connection point located at or adjacent to the first or second end of the slot. Here, "adjacent" should be interpreted as meaning that the distance between the first end and the connection point is comparable to the shortest distance between the first end of the slot and the central longitudinal axis. This is to improve radiation efficiency, as the maximum field is located at the center of the slot. However, the slot advantageously extends slightly beyond the connection point, where this extension can be configured to improve impedance matching between the wireless communication module and the slot. For impedance matching, such a microstrip is typically configured to have a resistance of approximately 50Ω, specifically, a real part of 50Ω (imaginary part of 0Ω). The most convenient way to achieve this is often to appropriately select the width, as the length of the microstrip line is often selected to maximize the potential difference between the point where the microstrip line connects to the wireless connection module and the point where the microstrip line connects to the slot. To avoid undesirable interference effects, it can be useful to arrange the majority of the microstrip line segment on the side of the second area of ​​the FPCB opposite the slot antenna. One end of the microstrip line (i.e., the end that should be connected at the connection point) then passes through an opening in the second area at or near the connection point. If the wireless connection module is placed on the same surface of the FPCB as the antenna, another opening will need to be provided in the first area to connect to the wireless connection module. If the wireless connection module is placed in the first area, the microstrip line will be printed via the curved portion connecting the first and second areas; however, the wireless connection module can also be placed in the second area, in which case this is not necessary.

[0037] A big problem with communicating with devices located inside the human body is that body tissue is a lossy medium and can have significant near-field losses. Slot antennas are a favorable choice in this situation because they have a weak electric near-field; however, this alone has proven to be insufficient, especially for slot antennas with such tight size constraints.

[0038] To further reduce losses, a ceramic buffer is placed above the slot antenna in the second region. While the use of these ceramic buffers has been considered before, their advantages have been found to be particularly pronounced in this particular context and application. In particular, while such a buffer may already have some positive impact on radiation outside the body, these improvements are even more pronounced when the device is inserted, making it possible to minimize the size of the antenna to fit within the confined space of the loop.

[0039] The ceramic buffer can have a variety of shapes and sizes; however, it preferably has a first major surface that covers the slot antenna, wherein the first major surface is preferably substantially parallel to the surface of the second region, such that the distance between the second region and the first major surface is substantially constant. The first major surface can have a larger area than the second region, or can have the same area; preferably, at least all of the second region on which the slot antenna is arranged is covered by the ceramic buffer, so that the slot antenna can, in a sense, "capture" the near field.

[0040] In general, it has been found that improved results are achieved if the ceramic buffer is configured so that it substantially fills the space between the nearest portion of the device's outer wall (i.e., the portion of the outer wall located above the slot antenna when viewed along the central axial axis) and the slot antenna. In other words, the ceramic buffer is advantageously shaped and dimensioned so that the first major surface is defined by the size, shape, and position of the second region, and the opposing surface is shaped to conform to the interior of the housing. This also ensures that there is little to no air between the radiating surface of the slot antenna and the housing, which further helps reduce losses and improve impedance matching with surrounding tissue.

[0041] It is even conceivable to have this surface of the ceramic buffer form part of the surface of the device itself, or even to make at least a portion of the housing from a medically acceptable ceramic or ceramic-containing material.

[0042] Zirconia has proven to be a favorable choice of material for the ceramic material. Preferably, the relative dielectric constant ε of the ceramic buffer is r Between 10 and 50, in particular between 20 and 40, or even more preferably between 25 and 35. This is related to the fact that the relative permittivity of the human body is typically between 40 and 60.

[0043] Due to the fact that many components are arranged in a small space, the intensity, directionality, and even frequency of the emitted radiation are affected by various factors. Therefore, it cannot be assumed that the antenna characteristics measured outside the device and outside the body will remain unchanged. For example, different values ​​for operating frequency and matching level have been found depending on: the presence or absence of a buffer; the arrangement relative to the motor; the curvature of the FPCB; and even the material of the housing. In some cases, these effects result in frequencies no longer within the band required for Bluetooth communication.

[0044] In this device, at least one adhesive layer is present, primarily securing the first major surface ceramic buffer to the surface of the second region of the FPCB, and therefore above the slot antenna. Surprisingly, the thickness and material properties of this adhesive layer have also been found to influence the radiation characteristics. Specifically, while many of the aforementioned elements cause the antenna's operating frequency to shift to a lower value, it has been found that careful selection of the thickness of the at least one adhesive layer can compensate for at least a portion of this shift.

[0045] Note that in some cases, a similar effect might be achieved by increasing the distance between the second area of ​​the FPCB and the first major surface of the ceramic buffer in some other manner. However, a surprising improvement has been observed when comparing the results with a properly selected adhesive layer (or multiple adhesive layers) to the results when mechanical spacers are used to ensure the same or similar distance between the second area of ​​the FPCB and the first major surface of the ceramic buffer.

[0046] It was found to be preferred for the at least one adhesive layer to have a thickness of between 50 μm and 200 μm, preferably between 80 μm and 170 μm, more preferably between 90 μm and 120 μm.

[0047] Furthermore, it has been found that the radiation performance of the proposed ring degrades over time in certain circumstances. However, this degradation can be limited by judiciously selecting the thickness and / or material properties of the at least one adhesive layer. Particularly favorable results have been observed when the at least one adhesive layer is a multilayer structure, for example, when a carrier layer is included between two adhesive layers. The carrier layer is preferably a polyester layer, and the two adhesive layers are preferably modified acrylic adhesive layers; however, the favorable effects do not appear to be limited to these specific material choices.

[0048] In general, the dimensions of the antenna pattern, the dimensions of the ceramic buffer, and the placement of the FPCB as a whole within the device are highly constrained by the small dimensions required to allow vaginal insertion and comfortable placement within the body. This limits the configurability of these components. However, even relatively late in the design process, there is some greater freedom in selecting the thickness and / or material properties of at least one adhesive layer, and in advantageous embodiments, this makes it possible to compensate for the effects of the ceramic buffer, motor, curved FPCB, and / or housing on the operating frequency, thereby ensuring that the signal emitted by the device remains within the Bluetooth frequency band. Furthermore, this can help optimize matching levels and prevent degradation of signal properties over time.

[0049] In an embodiment, the device further comprises a first rigid member having a first end and a second end; a second rigid member having a third end and a fourth end; a first flexible member coupled between the first end and the third end; and a flexible portion coupled between the second end and the fourth end. In such a device, the reservoir can then be housed in the first rigid member; the outlet can be provided in an outer wall of the second rigid member; the pump and the motor can be housed in the second rigid member; and the device further comprises a tube passing through the first flexible member and providing a fluid communication path between the reservoir and the outlet. If the pump is a roller pump, the pump is preferably arranged to push the fluid through the tube to the outlet.

[0050] However, the elements described above may also be implemented in other types of pessary devices.

[0051] In particular, it is noteworthy that this application focuses on embodiments that include a drug delivery unit, as these tend to present the greatest challenges: the size of the motor and pump can only be minimized to a certain extent, and the size of the reservoir should be large enough so that the drug does not require frequent refilling. For embodiments that only have a sensing unit and no drug delivery unit, the constraints may be less stringent in at least some respects, depending on the sensor chosen; in particular, in such embodiments, the various electronic components (including any sensors) can also be arranged elsewhere in the device. However, even in such embodiments, achieving the desired radiation characteristics has proven challenging, and the principles outlined in this application can be advantageously applied.

[0052] The device may also include a power source, such as a battery, preferably housed in the second rigid member. This battery can provide power to the FPCB, as well as the motor (if present), and / or other components. The battery can be arranged so that its terminals contact terminals on another area of ​​the FPCB, which can be configured as a side flap. The motor is advantageously positioned between the power source and the pump. At least one sensor (if present) can be disposed in the first and / or second rigid member, though it should be noted that some types of sensors can be at least partially disposed in the flexible section of the device.

[0053] The invention will be further elucidated with the aid of the accompanying drawings, in which:

[0054] Figure 1 Insertion and positioning of a typical vaginal ring device is shown;

[0055] Figure 2A and Figure 2B An exemplary pessary device is shown in its extended and contracted states, respectively;

[0056] Figure 3is a perspective view of an embodiment of a pessary device according to the present invention, wherein the top portions of the first and second rigid members are shown separated from the remainder of the device;

[0057] Figure 4 is a perspective view of an embodiment in which the top of a member in which the FPCB is arranged is removed;

[0058] Figure 5 yes Figure 4 A top view of an embodiment of the invention;

[0059] Figure 6 shows a cross section of a portion of a pessary device, wherein the FPCB is arranged along a radial direction;

[0060] Figure 7A and Figure 7B is a perspective view showing the interior of a portion of a rigid member in which an FPCB is arranged;

[0061] Figure 8A A ceramic buffer according to the present invention is shown, which is arranged on the second area of ​​the FPCB; Figure 8B Another ceramic buffer is shown;

[0062] Figure 9A and Figure 9B Two possible embodiments of the second region according to the invention are schematically shown;

[0063] Figure 10 An example of a flexible circuit board according to the present invention is schematically shown.

[0064] In the following, the same reference numerals are used to refer to similar elements; unless otherwise indicated, a description of an element in the context of one figure also applies to elements with the same reference numeral in other figures.

[0065] Figure 1 The insertion and positioning of a known pessary device 100 in use are shown; such devices are respectively Figure 2A and Figure 2B It is shown in its extended and retracted states.

[0066] exist Figure 1, the user's body 200 is shown indicating the urethra 201, vagina 202, and uterus 203. Before inserting the device 100, the device is squeezed to transform its shape into a contracted state. Thereafter, the user inserts the device 100 into the vagina 202 and moves the device 100 close to the uterine cervix 204 or uterine vault 205, where the device 100 is released. Due to the elasticity of the device, the device 100 at least largely returns to its original shape. Due to the shape and size of the device, the device 100 rests against the vaginal wall. This positioning allows for localized, gradual drug release, as well as for performing appropriate measurements. Furthermore, this positioning ensures that the user observes little to no pain, and any impact of the device 100 on sexual intercourse is minimized.

[0067] Figure 2A and Figure 2B The device is shown in greater detail both in its extended state, in which it is biased and restored once positioned, and in its retracted state for insertion.

[0068] This shape includes a first rigid member 101, a second rigid member 102, a first flexible member 111, and a flexible portion 110. Here, first flexible member 111 is made of an elastic material and includes a recess 105 to allow first and second rigid members 101, 102 to move toward each other when device 100 is squeezed into its contracted state. Flexible member 111 and / or flexible portion 110 are pre-biased so that when little or no external force is applied to them, the device will (re)assume its extended shape. In the extended shape, the device has a generally elliptical or toroidal shape extending about a central axial axis A. For the purposes of the following description, the precise location of this (theoretical) axis A is not particularly relevant, but its orientation can be used to define the "top" and "bottom" of the device.

[0069] According to the present invention, the functional portions of the drug delivery and / or diagnostic mechanism are preferably incorporated into rigid members 101, 102, while any necessary electronic and / or fluidic connections between these functional portions may be housed in flexible member 111 or flexible portion 110. However, some functional components may also be housed in flexible member 111 and / or flexible portion 110. For example, it is not excluded that (a portion of) one or more sensors may be advantageously housed in or as part of flexible member 111 and / or flexible portion 110; or that flexible member 111 and / or flexible portion 110 may be configured to advantageously influence the radiated signal. In other examples, flexible portion 110 may be composed of multiple parts, some of which may be rigid.

[0070] It should be noted that the present invention is not limited to this particular pessary device, and the principles outlined herein can also be applied to a variety of other or yet-to-be-developed pessary devices. However, all of these devices share similar limitations, notably the need to house many of the electronic components within one or more rigid portions, which are limited in size and shape by the required retractability. The outer diameter of the device, as measured in a plane perpendicular to axis A, is typically between 50 mm and 70 mm, more preferably between 55 mm and 65 mm, and the inner diameter, as measured in a cross-section parallel to axis A, is typically between 4 mm and 8 mm. Given this, the dimensions of all components are significantly limited.

[0071] Figure 3 is a perspective view of an example vaginal ring device. The device includes a drug delivery unit; although not shown, the device may also include a sensing unit including one or more sensors. In the depicted embodiment, the first rigid member 101 and the second rigid member 102 are each formed by a top shell portion 13, 13' and a bottom shell portion 14, 14' that can be attached to each other in a waterproof manner; however, it is conceivable to form the rigid members in a different manner, such as as an integrally formed tube into which the components can be inserted. To illustrate the arrangement of the various components, in Figure 3 In the figure, top housing portions 13 and 13' are shown separated from the device. In some embodiments, this represents a stage of the assembly process; however, the top and bottom housing portions may be assembled to form the rigid member before rigid members 101, 102 are assembled with flexible portions 110 and 111. Some or all components may also be manufactured by injection molding and / or 3D printing. Although not shown, these top housing portions 13, 13' and bottom housing portions 14, 14' may include means on their inner surfaces for positioning and / or supporting various components.

[0072] It should be clear that for all discussed embodiments, mirror image arrangements are also possible, particularly in embodiments such as the illustrated embodiment where the rigid members 101 , 102 are substantially similar in size and symmetrical in shape.

[0073] The drug delivery unit includes a reservoir 4 for storing the medication to be delivered, housed within a second rigid member 102. In this embodiment, an outlet 6 for dispensing the medication is located within the outer surface of the first rigid member 102, specifically along the junction between the top housing portion 13 and the bottom housing portion 14; however, this outlet could be located elsewhere. Since, in this embodiment, the reservoir 4 and outlet 6 are located within different rigid members, a tube 5 providing a fluid connection between the reservoir 4 and outlet 6 passes through the flexible member 11; this tube is therefore also flexible. In this embodiment, dispensing of the medication is controlled using a roller pump 7, which is located near the outlet and can be controlled to push the fluid active ingredient within the tube through the tube and outward at the tube outlet into the vaginal cavity. However, other types of pumps could also be used, in which case it would be possible to house the pump within the rigid member housing the reservoir 4 instead. The outlet 6 and roller pump 7 are preferably positioned relatively close to the flexible member 111 to minimize the required tubing length.

[0074] Note that the details of the drug delivery unit are not the focus of this application, and the unit will typically include additional elements not depicted in these figures. Thus, the rigid member in which the reservoir 4 is disposed will typically also include a valve, such as a reverse vacuum pressure valve, to compensate for pressure changes caused when the reservoir is emptied to dispense the medication and to prevent fluid from the vaginal cavity from entering the device. A filling port may also be provided in the rigid member in which the reservoir 4 is disposed to allow the reservoir to be (re)filled.

[0075] To drive the pump, a motor 8 is also arranged in the first rigid member 101, with its longitudinal axis oriented substantially along the annular direction of the ring, i.e. perpendicular to the radius. A battery 10 is also arranged in the first rigid member 101 to provide power both to the motor 8 and to the control electronics on the first region 9 of the FPCB 30.

[0076] In this embodiment, the first region 9 of the FPCB 30 is arranged to face the outer circumference of the ring device 100. In this embodiment, the FPCB is bent at three bending regions 24, 24' and 24", which connect the first region 9 to the second region 11 (at Figure 3 (not visible in the figure), the slot antenna is positioned on this second region. Therefore, second region 11 is substantially perpendicular to first region 9. Due to this curvature, FPCB 30 can be arranged very compactly around motor 8 in the space between motor 8 and the housing. Ceramic buffer 12 is positioned above second region 11, specifically to fill most of the space between second region 11 and the section of top housing member 13 located above second region 11.

[0077] Figure 4yes Figure 3 30, in which the top housing portion 13 of the first rigid member 101 is omitted. In this figure, it can be seen that in this embodiment, the FPCB also includes another side wing, which in this case is connected to the second area 11, which provides the connection to the terminals 15 of the motor 8. However, other ways of connecting the motor 8 to the FPCB 30 and the motor 8 can also be used. Although not shown in this figure, the FPCB also includes a further section / area that can be arranged to be connected to the two terminals of the battery 10 to ensure the power supply to the various electronic device components on the FPCB and the motor 8.

[0078] Figure 5 A top view of the same embodiment is shown, wherein not only the top housing portion 13 but also the ceramic buffer 12 is omitted in order to illustrate the arrangement of the slot antenna on the second area 11. Note that the shape of the slot antenna in this figure is schematic and is not intended to illustrate a specific path shape.

[0079] Figure 6 1 is a schematic cross-section of first rigid member 101, illustrating the arrangement of first region 9 and second region 11 of the FPCB connected by bend region 24 around motor 8. The figure also illustrates one possible way to securely attach top housing portion 13 to bottom housing portion 14. Furthermore, as can be seen in the figure, ceramic buffer 12 is configured so that there is virtually no empty space between second region 11, on which the slot antenna is provided, and the inner surface of top housing portion 13.

[0080] Figure 7A and Figure 7B Only the first rigid member is shown, with several elements such as the pump 7 and battery 10 omitted to more clearly illustrate the arrangement of the FPCB 30 around the motor 8. It can be seen that the FPCB 30 is bent along bend regions 24, 24', and 24" so that the first region 9 and the second region 11 are substantially perpendicular to each other, and is bent along another bend region 17 to provide the terminal 15. However, this angle need not be perpendicular; furthermore, the first region 9 itself can be embodied to include several sub-regions that may not all be in the same plane, as shown below.

[0081] Although the figures discussed above do not show a sensing unit, it will be clear to those skilled in the art that various sensors may be arranged in the illustrated apparatus in addition to or in place of the various elements of the drug delivery unit depicted in these figures. These sensors are then typically communicatively coupled to (at least) the control circuitry so that the sensor values ​​measured by the sensors can be relayed, processed, and / or analyzed.

[0082] Although the sensing unit in the vaginal device may advantageously be used (also) for diagnostic purposes, the present invention is not limited to such sensors, and the device may also comprise one or more sensors for internal regulation purposes.

[0083] For example, in an embodiment with a drug delivery unit, it may be useful to provide a temperature sensor (which does not need to be particularly precise), such as one located on the FPCB, to simply check whether the device's temperature is close to that of the human body, thereby indicating that the vaginal device is currently inserted into the vagina. In this case, the value measured by the sensor does not need to be transmitted to another device, but the control circuitry can, for example, be configured to interrupt drug delivery if the sensed temperature value indicates that the device is not currently inside the human body. In another example, a sensor can be provided to monitor the amount of medication remaining in the reservoir. In such a case, the control circuitry can be configured to use the sensor information to confirm the proper operation of the drug delivery mechanism and / or to issue an alarm if the reservoir is nearly empty (via a wireless communication module or some other means). The combination of a drug delivery unit and a sensing unit can also be used to provide a self-regulating feedback mechanism, in which the measured level of the active ingredient of the medication or the level of a factor indicating the current need for the medication is used to control the drug delivery mechanism. For example, for a diabetic patient, a blood glucose sensor can be used to regulate insulin release.

[0084] In the above cases, it may not be necessary to transmit sensor measurements, or values ​​derived from these measurements, to an external device via a wireless communication module using an antenna, but it may still be useful. For example, the above-mentioned temperature measurement indicating whether the device is in place can be used to confirm compliance / medication adherence.

[0085] This transmission of measurements is of course particularly advantageous if the sensing unit—which can be provided with the drug delivery unit or separately—includes a diagnostic sensor / biosensor. Monitoring body temperature (which may include analyzing temperature fluctuations) for fertility monitoring has already been mentioned above. Note that this would require a more accurate temperature sensor than the one described above, preferably positioned so that it can measure the temperature of the surrounding tissue while being minimally affected by heat generated by the various electronic components. To further improve the accuracy of fertility monitoring (including in vitro fertilization), the device could include, in addition to (or in lieu of) at least one temperature sensor, a biosensor that measures luteinizing hormone (LH) and / or estradiol (E2) levels. Such a biosensor may require direct contact with the vaginal mucosa. To this end, if relevant measurements are required, the device could be provided with at least one opening and / or membrane. Such an opening and / or membrane would be located on the outer or inner periphery of the ring at a position to ensure optimal contact with the vaginal mucosa or cervical mucus.

[0086] However, diagnostic applications are not limited to those related to fertility, or even more generally to gender-specific issues. The sensing unit may comprise any type of sensor that can measure diagnostically relevant information when inserted into the human body. This may even include microfluidic sensors, preferably lab-on-a-chip type microfluidic sensors, which are capable of detecting various complex modules such as biomarkers in fluids obtained from the surroundings of the device, provided, of course, that these sensors can be miniaturized sufficiently so that they fit within the device. In general, it is preferred to use sensors with a maximum diameter of 1 cm and a thickness of no more than 5 mm. Note that the analysis and processing required to interpret the signals from such sensors may be performed by a processing module in the device; by at least one external device to which the data is transmitted; or by appropriately distributing the required calculations between one or more modules provided in the device and at least one external device.

[0087] Figure 8A and Figure 8B Two example ceramic bumpers 12 are shown. Although the specific shapes differ, these ceramic bumpers all have a flat first major surface that is flat on the Figure 8A 1 is shown attached to the second region 11 via at least one adhesive layer 18. The other major surface is curved according to the shape of the section of the inner surface of the rigid member where the FPCB is arranged, so that the space between the slot antenna on the second region 11 and the inner surface is substantially filled.

[0088] Figure 9A and Figure 9B Two possible embodiments of the slot antenna, in particular the slot 19, on the second region 11 are shown. The slot antenna is provided as a slot 19 in the metal coating 16 on the second region 11, i.e. as a path where this coating is removed (or not provided). The slot antenna is provided as a single elongated slot 19 which extends from the first end 20 to the second end 22 along a meandering or twisting path such that the total path length is substantially longer than the shortest distance between the first end 20 and the second end 22. This is because, due to the limited space available in such a pessary device, the length of the second region is typically of the order of 1 cm to 2 cm, which is generally insufficient to generate a Bluetooth signal, in particular a Bluetooth signal of sufficient strength. Figure 9A and Figure 9BIn the example shown, the path length from connection point 21 to second end 22 corresponds approximately to 2λ, or nλ / 2, where n=4. This, in combination with other elements, produces sufficient radiation intensity within the spatial constraints of a device including a drug delivery unit. The remaining section of slot 25 between connection point 21 and first end 20 is selected to optimize impedance matching with the wireless communication module / Bluetooth chip. First end 20 and second end 22 are typically located at opposite ends of second region 11, although this is not always necessary. The width of the slot (which is preferably substantially constant along the length of the path) is typically approximately 0.2 mm to 0.4 mm; to avoid interference, the distance between adjacent portions of the slot should be at least as great as this width.

[0089] exist Figure 9A In the embodiment of the present invention, there are three bending areas 24, 24' and 24" connecting the second area 11 of the FPCB to the first area 9; Figure 9B In , there are two bending areas 24, 24'. It is not excluded that the first area 9 and the second area 11 will be connected over the entire length; however, the use of smaller separate bending areas tends to facilitate correct bending and positioning. In addition to this, one of the bending areas also provides a path for the microstrip line 23. Although the microstrip line 23 is depicted in these figures, advantageously the majority of the microstrip line is provided on the surface opposite to the surface where the slot antenna is provided and will therefore not be visible. At the connection point 23, a through-hole is then provided in the second area 11. Note, however, that in order to avoid interference, the microstrip line 23 should generally not overlap or cross the slot 19 except close to the connection point 21. In Figure 9A In the embodiment, the path of the slot 19, in particular the length of the vertically extending section in the figure, is suitable for leaving space for the microstrip line 23; Figure 9B In the embodiment of FIG, this is not necessary. The microstrip line 23 terminates at a connection point 21, which is close to the first end 20 of the slot 19; as mentioned, although the section of the slot 19 between the connection point 21 and the first end 20 does not directly affect the radiated signal, it is useful for improving the impedance matching with the wireless communication module / Bluetooth chip to which the slot is connected via the microstrip line 23, and the length of the slot is preferably selected based on this.

[0090] Figure 10 FIG. 3 shows a schematic diagram of an FPCB 30 according to the present invention, in particular before it is bent and arranged in a device (ie arranged in a plane). In this figure, the Figure 9AThe second region 11 is connected to the first region 9 via curved regions 24, 24' and 24"—fewer or more curved regions may also be used. The second region 11 is also connected to a motor connection region 26 via curved region 17, which includes terminals 15 and 15' for connection to the motor.

[0091] In this embodiment, the FPCB has a third region 9', which is connected to the first region 9 via further bend regions 27, 27' and 27", and is arranged on a side of the first region 9 opposite to the second region 11. Therefore, the FPCB can be bent at bend regions 24, 24' and 24", as well as bend regions 27, 27' and 27", so that the FPCB can be arranged to partially surround components arranged along the circumference of the device, such as the motor 8 depicted in some of the other figures. Note that region 9' can also be regarded as a sub-region of the first region, where the first region is then formed by the combination of regions 9 and 9' - in general, the first region does not have to be arranged in a single plane in the device, nor does it have to include the entirety of the control circuit system.

[0092] exist Figure 10 In the embodiment shown, the main processing unit 31 and the wireless communication module 32 are arranged on the first area 9; the additional control circuit system, in particular the power management control circuit system 33, is advantageously arranged on the third area because, in the depicted embodiment, the battery connection area 29 is connected to the third area 9' via the additional curved area 17'. The battery connection area 29 includes battery terminals 28 and 28' and is shaped and configured so that it can be bent and arranged around a battery (such as the battery 10 shown in some other figures) so that the battery terminals 28 and 28' contact the terminals of the battery.

[0093] For readability reasons, Figure 10 The connections between the various components are not depicted in FIG - and in fact, at least some of these connections, in particular the microstrip line 23, may be arranged on the other side of the FPCB and therefore not necessarily visible in such a view. If the connections are indeed arranged on the other side, through-holes can be formed by providing openings in the FPCB 30, for example at the connection points 21.

[0094] As previously discussed, the wireless communication module 32 is connected to the slot antenna 19 at the connection point 21. Both the communication module 32 and the power management circuitry 33 need to be communicatively coupled (directly or indirectly) to the control circuitry of the main processing unit 31; in this particular embodiment, the connection between the power management circuitry 33 and the main processing unit 31 may be provided using one of the flex regions 27, 27' or 27". Furthermore, since the main processing unit 31 must be able to send commands to the motors, it must be connected, directly or indirectly, to the motor connection terminals 15, 15'; this connection may be provided, for example, using the flex regions 17 and 24, although other solutions are also contemplated. The power management circuitry 33 must in turn be connected to the battery terminals 28 and 28'; this connection may be provided via the flex region 17'.

[0095] Notice, Figure 10 is schematic; the positioning, shape and size of the various components and terminals should not be regarded as representative of or limiting the actual positioning, shape and / or size. In addition, although in this embodiment the battery connection area 29 extends from the third area 9' and the motor connection area 26 extends from the second area 11, it should be clear that this is in view of the specific arrangement and relative positioning of the various components in the specific device for which the FPCB is intended to be used. For example, in a device that includes a sensing unit but does not include a drug delivery device, the motor will probably not be required and the motor connection area 17 can be omitted. In addition, although in this embodiment there is only one antenna 19 arranged on the second area 11, there may be at least one additional antenna that can be arranged on the second area 11; arranged on Figure 10 or be arranged on another area not included in the figure. Antenna arrays can also be considered.

[0096] By using a slot antenna of the type discussed above, and providing and arranging the FPCB 30 as depicted, useful directionality in Bluetooth signal strength is achieved. Specifically, it was found that for subjects with a BMI of up to 36, sufficient signal strength for Bluetooth communication could be achieved not only by positioning the smartphone between the user's legs (which is typically the most advantageous position, but can be inconvenient, especially in public), but also when the smartphone was held close to the user's pelvis, and even when the smartphone was in the user's back pocket. Due to the details of this embodiment, with the antenna positioned on the left side of the device, slightly better results were observed when the smartphone was in the right pocket rather than the left pocket, but this will of course vary with different placement options, and sufficient connectivity was achieved in either pocket.

[0097] In the foregoing, the present invention has been disclosed with reference to embodiments thereof. However, it will be clear to those skilled in the art that the arrangement shown, while highly advantageous, is only one of many possibilities. Overall, it has been discovered that the combination of a slot antenna arranged on an area of ​​a flexible printed circuit board and attached to a ceramic buffer via at least one adhesive layer ultimately enables something previously unattainable: robust and reliable Bluetooth connectivity within a very confined space. It will be understood by those skilled in the art that various modifications may be made without departing from the invention, the scope of which is defined by the appended claims.

Claims

1. A vaginal drug delivery and / or sensor device (100), comprising: A drug delivery unit comprising a reservoir (4) for holding a medicament to be delivered, an outlet (6), a pump (7) for pumping the medicament out of the outlet (6), and a motor (8) for actuating the pump (7); and / or a sensing unit, comprising one or more sensors; A flexible printed circuit board (FPCB) (30) comprising a first area (9) and a second area (11); a control circuit system (31) disposed on the first area (9) of the FPCB (30) and communicatively coupled to the drug delivery unit and / or the sensing unit; a wireless communication module (32), arranged on the FPCB (30), preferably configured for Bluetooth communication, wherein the wireless communication module is communicatively coupled to the control circuit system (31); Characterized in that the device also includes: a slot antenna formed on the second area (11) of the FPCB (30) by providing a slot (19) in a metal layer (16) arranged on the second area (11); a microstrip line (23) connecting the wireless communication module (32) to a connection point (21) located at a first end (20) of the slot (19) or adjacent to the first end; a ceramic buffer (12) arranged on the slot antenna on the second area (11); and At least one adhesive layer (18) is arranged between the ceramic buffer (12) and the slot antenna on the second area (11) Wherein, a plurality of independent slot antennas are provided; and / or The slot (19) of the slot antenna has a first end (20) and a second end (22), and extends along a path between the first end (20) and the second end (22), so that the total length of the slot (19) is significantly greater than the shortest distance between the first end (20) and the second end (22).

2. The device according to claim 1, wherein: The first region (9) and the second region (11) of the FPBC are connected via at least one bending region (24, 24', 24") of the FPCB.

3. The device according to claim 1 or 2, wherein: The first region (9) is substantially planar, and wherein the first region (9) is arranged at an angle to at least a portion of the second region (11), preferably substantially perpendicular to at least a portion of the second region (11).

4. The device (100) according to any one of the preceding claims, wherein: The device (100) is deformable between an extended shape, which is assumed when little or no external force is applied to the device and corresponds to a substantially elliptical or toroidal shape extending about a central axial axis, and a contracted shape that allows the device to be inserted into the vagina of a user.

5. A device according to any one of the preceding claims, wherein: The slot (19) of the slot antenna has a first end (20) and a second end (22), and extends along a path between the first end (20) and the second end (22), so that the total length of the slot (19) is significantly greater than the shortest distance between the first end (20) and the second end (22).

6. The device (100) according to any of the preceding claims, comprising a drug delivery unit, wherein: The motor (8) is at least partially arranged in a space defined by the first area (9) of the FPCB and the second area (11) of the FPCB.

7. The device (100) according to any one of the preceding claims, wherein: The control circuit system (31) and any other components arranged on the first area (9) are arranged on a side of the first area (9) of the FPCB (30) at a nearest portion of the outer surface facing the device.

8. The device (100) according to any one of the preceding claims, wherein The second region (11) is arranged substantially in a first plane perpendicular to a central axial axis (A) of the device.

9. The device (100) according to any one of the preceding claims, wherein: The slot antenna is arranged on a side of the second region (11) oriented toward the ceramic buffer (12), or is arranged on a side of the second region (11) oriented away from the ceramic buffer (12).

10. The device (100) according to any one of the preceding claims, wherein The second region (19) is formed as a side wing piece of the FPCB (30).

11. The device (100) according to any one of the preceding claims, wherein The length of the slot from the connection point (21) to the end (22) farthest from the connection point is approximately an integer multiple of λ / 2 or an integer multiple of λ / 4, wherein λ is the wavelength of the communication signal.

12. The device (100) according to any one of the preceding claims, wherein The second region (11) is substantially rectangular having two shorter sides and two longer sides, wherein the first end (20) of the slot is located adjacent to a first one of the shorter sides and the second end (22) of the slot (19) is located adjacent to the other one of the shorter sides.

13. The device (100) according to claim 12, wherein: The second region (11) is connected to the first region (9) over at least a portion of a first one of the longer sides or over a portion of a first one of the shorter sides of the second region.

14. The device (100) according to claim 12 or 13, wherein: The slot (19) follows a serpentine path comprising: a longer section extending substantially parallel to the width of the second region (11); and a shorter section extending substantially parallel to the length of the second region (11), the shorter section connecting one of the ends of an adjacent longer section.

15. The device (100) according to claim 14, wherein The distance between two adjacent longer sections is comparable to or greater than the width of the slot (19).

16. The device (100) according to any one of the preceding claims, wherein The microstrip line (23) is configured to have a resistance of about 50Ω.

17. The device (100) according to any of the preceding claims, wherein The microstrip line (23) bridges the slot (19) close to the connection point (21).

18. The device (100) according to any one of the preceding claims, wherein Most of the section of the microstrip line (23) is arranged on a side of the second area (11) of the FPCB (30) opposite to the slot antenna, and one end of the microstrip line (23) passes through an opening in the second area (11) at or near the connection point (21).

19. The device (100) according to any one of the preceding claims, wherein The ceramic buffer (12) has a first major surface covering the slot antenna, wherein the first major surface is preferably substantially parallel to a surface of the second region (11).

20. The device (100) according to any of the preceding claims, wherein The ceramic buffer (12) is configured such that the ceramic buffer substantially fills a space between a nearest portion of an outer wall of the device (100) and the slot antenna.

21. The device (100) according to any one of the preceding claims, wherein The ceramic buffer (12) is made of zirconium oxide or includes zirconium oxide.

22. The device (100) according to any of the preceding claims, wherein The ceramic buffer (12) has a relative dielectric constant ε between 10 and 50 r , preferably between 20 and 40, more preferably between 25 and 35.

23. The device (100) according to any of the preceding claims, wherein The at least one adhesive layer (18) has a thickness between 50 μm and 200 μm, preferably between 80 μm and 170 μm, more preferably between 90 μm and 120 μm.

24. The device (100) according to any of the preceding claims, wherein The at least one adhesive layer (18) comprises a carrier layer between two adhesive layers, wherein the carrier layer is preferably a polyester layer and the two adhesive layers are preferably modified acrylic adhesive layers.

25. The device (100) according to any of the preceding claims, wherein The thickness and / or material properties of the at least one adhesive layer (18) are selected to achieve desired radiation characteristics, preferably compensating for the effects of the ceramic buffer (12), the motor (8), the FPCB (30) and / or the housing of the device on the operating frequency, thereby ensuring that the signal transmitted by the device is in the Bluetooth frequency band.

26. The device (100) according to any of the preceding claims, wherein The device also includes: A first rigid member (101) having a first end and a second end; A second rigid member (102) having a third end and a fourth end; A first flexible member (111) coupled between the first end and the third end; A flexible portion (110) is coupled between the second end and the fourth end.

27. The device (100) according to claim 24, comprising a drug delivery unit, wherein: The reservoir (4) is accommodated in the first rigid member (101); The outlet (6) is arranged in the outer wall of the second rigid member (102); The pump (7) and the motor (8) are housed in the second rigid member (102); and The device (100) further comprises a tube (5) passing through the first flexible member (111) and providing a fluid communication path between the reservoir (4) and the outlet (6); Wherein, the pump (7) is preferably a roller pump.

28. The device (100) according to claim 26 or 27, further comprising a power source (10), such as a battery, preferably housed in the second rigid member (102).

29. The device (100) according to claims 27 and 28, wherein The motor (8) is arranged between the power source (10) and the pump (7).

30. The device according to any one of claims 24 to 27, wherein: At least one sensor is arranged in the first rigid component (101) and / or the second (102) rigid component.

Images