WO2021037653A1

WO2021037653A1 - Infusion port with pairing functionality

Info

Publication number: WO2021037653A1
Application number: PCT/EP2020/073297
Authority: WO
Inventors: Henrik Bengtsson; Ronan Carroll
Original assignee: Novo Nordisk A/S
Priority date: 2019-08-23
Filing date: 2020-08-20
Publication date: 2021-03-04

Abstract

A skin-mountable patch device comprising a subcutaneous a fluid outlet and a fluid port in flow communication with the fluid outlet and adapted to receive a drug delivery device. The patch device is provided with electronic circuitry comprising detections means adapted to detect a patch pairing state in which a drug delivery device has been connected to the fluid port and/or that a fluid is being injected through the fluid port, and wireless communication means adapted for pairing with a drug delivery device having dose logging functionality. When a patch pairing state is detected the wireless communication means is operated to provide pairing with a pairable drug delivery device, and when a pairing between the patch device and a drug delivery device has been established, dose data can be received from the drug delivery device and stored in the patch device for subsequent transmission to the external device.

Description

INFUSION PORT WITH PAIRING FUNCTIONALITY

The present invention generally relates to devices and assemblies allowing a drug delivery device to be paired with a skin-mountable injection port.

BACKGROUND OF THE INVENTION

In the disclosure of the present invention reference is mostly made to the treatment of diabetes, however, this is only an exemplary use of the present invention.

Drug delivery devices for subcutaneous injection of a fluid drug formulation via a hollow needle have greatly improved the lives of patients who must self-administer drugs and biological agents. Drug delivery devices may take many forms, including simple disposable devices that are little more than an ampoule with an injection means to relatively complex pre-filled dispos able devices which may even be spring-driven, or they may be durable devices adapted to be used with pre-filled cartridges. Regardless of their form and type, they have proven to be great aids in assisting patients to self-administer injectable drugs and biological agents. They also greatly assist care givers in administering injectable medicines to those incapable of perform ing self-injections.

However, using a drug delivery device for subcutaneous injections usually means inserting a needle into the skin and inject a drug into the skin through the needle. Although smaller and smaller needle-tips are becoming available, a significant number of people feel uncomfortable inserting a needle into their skin. Not only the sting they feel, but also the mere sight of the needle and the thought of it entering their skin, cause discomfort for these people. To some of these people the anticipation of pain, increase their sensation of pain and makes the injections very unpleasant for these people. This may cause some of these people not to perform the injections quite as often as they should.

Addressing this issue injection ports have been developed which only require that the patient puncture their skin every few days to install an injection port, rather than injecting with a needle into their skin numerous times a day. Infusion ports employ a canula or tube inserted subcuta neously, and the patient injects the drug into the injection port adhering to their skin rather than directly into their cutaneous tissue, see e.g. US 9,987,476 which also discloses an injection port device provided with an additional canula allowing a sensor device to inserted at a dis tance from the drug delivery canula. In recent years, patches with build-in sensors monitoring the blood glucose level continuously is becoming more and more common in use by users of insulin. These patches contain a sen sor to measure the blood glucose level as well as some means of communications for the measurements to be made available to the user. Such patches have of course access to the blood in which to measure the glucose level. This access is on some cases established by a small, plastic catheter that is inserted in the skin below the patch and remains there for several days, some of them up to 14 days by now.

To enable the user to read the current blood glucose level, such patches are fitted with means of communication to a smartphone. This enables the user to log the variations in blood glucose and monitor it, to assist in dosing insulin injections.

If the patch is designed for it, the insulin injection will be detected by the Blood Glucose Meas uring Sensor, in which case the patch can add this information to the log on the user’s smartphone and thereby provide the user with a graphic representation of the blood glucose variations combined with the insulin injection pattern.

However, this information will be of reduced value, since the dose-size of each injection cannot be determined by the sensor, and the user would therefore have to input it manually. Such a solution would allow for a number of mistakes and resulting wrong or inadequate data. How ever, injection devices with means of wireless communication and electronic registering of out- dosing and/or able to store a log file of out-dosing has proposed, see e.g. WO 2019/110494.

Since patches are changed at least every two weeks, and a number of different devices and maybe even types of drugs may be used under a user-specific regime, it will be necessary to pair the injection device used with the patch used such that information from each used device can be incorporated in the patch log and transmitted to the user’s smartphone.

Such pairing is known from Bluetooth connections and similar, but since more devices than one may be within range (and maybe even more patches too) it presents a challenge to make sure the active patch pair with the injection device(s) actually used. Normally this would require some form of user verification that the established connection is between the two right units and, if not, that a repeated search for candidates is initiated. This in turn requires some form of user communication means on the injection device. WO 2016/045699 discloses a patch device adapted to capture dose data from a manually operated syringe by means of image capture, the type of syringe and drug being identified by label image or RFID. WO 2011/056888 discloses a medication injection device adapted to receive fluid from a medication source, e.g. a syringe, the device comprising a sensor adapted to generate information characterizing administration of the medication. The type of medication may be identified by e.g. optical or magnetic sensors or RFID interacting with the fluid source. The amount of medication received may be measured by a fluid flow sensor. US 2013/0116666 discloses an implantable drug pump and a refill device therefor. The pump and refill device can be paired and can exchange and store dose data. The drug pump refill port may be pro vided with sensor means allowing correct insertion of an infusion needle into the refill port to be detected and subsequently communicated to the user.

Having regard to the above, it is an object of the present invention to provide devices and methods enabling a skin-mountable drug delivery port to be paired with a given drug delivery device in a safe and user-friendly way. The drug delivery port may or may not incorporate sensor means such as CGM.

DISCLOSURE OF THE INVENTION

In the disclosure of the present invention, embodiments and aspects will be described which will address one or more of the above objects or which will address objects apparent from the below disclosure as well as from the description of exemplary embodiments.

Thus, in a first aspect of the invention a patch device is provided, comprising a base portion having a mounting surface adapted to be mounted on a skin surface of a patient, a fluid outlet allowing a fluid to be delivered subcutaneously when the patch device is mounted on a skin surface of a patient, a fluid port in flow communication with the fluid outlet and adapted to receive an outlet of a drug delivery device, as well as electronic circuitry. The electronic circuitry comprises a memory, detections means adapted to detect a patch pairing state in which a drug delivery device has been connected to the patch device and/or that a fluid is being injected through the fluid port, wireless communication means adapted for pairing with a drug delivery device provided with corresponding wireless communication means, the wireless communica tion means being further adapted to transmit data stored in the memory to an external device, and a processor operatively connected to the detection means, the wireless communication means and the memory. When a patch pairing state is detected the wireless communication means is operated to provide pairing with a pairable drug delivery device in a given predefined device pairing state, and when a pairing between the patch device and a drug delivery device has been established, dose data can be received from the drug delivery device and stored in the memory for subsequent transmission to the external device.

By this arrangement a safe and user-friendly way of pairing a patch device and an associated drug delivery device is provided, the pairing essentially being performed automatically without user involvement.

In order for the detections means to detect a patch pairing state the drug delivery device may have to be connected physically to the patch device, e.g. by means of galvanic contacts or a by activating a switch. Alternatively, the detection means may be adapted to detect a short- range signal from a drug delivery device, e.g. using NFC. The short-range signal is not in tended for pairing or transmission of dose data but is merely used as an indicator for the pres ence of a drug delivery device in such close proximity to the fluid port that it can be assumed that a physical connection is intended.

The pairing process may be initiated by the patch device when a patch pairing state has been detected. Pairing may be established with a given drug delivery device when in the pairing process data is received from the drug delivery device indicating that the drug delivery device within a given time range (+/-) from the time of detection of the patch pairing state has been operated by a user to set or expel an amount of drug.

Alternatively, the patch device may be responsive to a pairing request from a drug delivery device when a patch pairing state has been detected. Pairing may be established with the requesting drug delivery device when in the pairing process data is received from the drug delivery device indicating that the drug delivery device within a given time range from the time of detection of the patch pairing state has been operated by a user to set or expel an amount of drug.

The patch device may be able to be paired with more than one drug delivery device at any given time. Alternatively, when paired with a new drug delivery device the pairing with a previ ously paired drug delivery device may be cancelled. When a patch pairing state is detected the wireless communication means can be operated to re-establish connection with an already paired drug delivery device. When out of pairing state the patch device may be unable to re connect. In an exemplary embodiment the patch device further comprises a sensor adapted to generate a signal indicative of a parameter value of a body fluid, the sensor being adapted to be ar ranged subcutaneously when the patch device is mounted on a skin surface of a patient. The processor is operatively connected to the sensor for transferring measuring data based on sensor signals to an external receiver via the wireless communication means. The sensor may be a CGM sensor.

In a further embodiment a patch device as described above is provided in combination with a drug delivery device comprising corresponding wireless communication means, wherein the drug delivery device comprises detections means adapted to detect a device pairing state in which the drug delivery device has been connected to the fluid port, and when a device pairing state is detected the wireless communication means is operated to provide pairing with the patch device.

In exemplary embodiments the patch device is provided in combination with a drug delivery device, the drug delivery device comprising a distal end portion with a drug outlet adapted to be arranged in fluid communication with the catheter lumen via the external fluid port. The external fluid port and the end portion may be adapted to engage each other in a form fitting relationship securing a predetermined orientation of the drug delivery device relative to the base portion.

The patch device and drug delivery device combination may be designed such that the external fluid port and the drug delivery device end portion prior to engagement comprise no user- visible needle.

For example, the external fluid port may comprise an initially hidden pointed hollow needle and the drug outlet may comprise a needle-penetratable septum. Alternatively, the drug outlet may comprise an initially hidden pointed hollow needle with the external fluid port comprising a needle-penetratable septum. As a further alternative a needle-free flow communication can be established between the drug delivery device and the external fluid port, e.g. comprising elas tomeric valve members which are controlled by pressure and/or engagement.

As used herein, the term "drug" is meant to encompass any flowable medicine formulation capable of being passed through a delivery means such as a cannula or hollow needle in a controlled manner, such as a liquid, solution, gel or fine suspension, and containing one or more drug agents. The drug may be a single drug compound or a premixed or co-formulated multiple drug compounds drug agent from a single reservoir. Representative drugs include pharmaceuticals such as peptides (e.g. insulins, insulin containing drugs, GLP-1 containing drugs as well as derivatives thereof), proteins, and hormones, biologically derived or active agents, hormonal and gene based agents, nutritional formulas and other substances in both solid (dispensed) or liquid form. In the description of the exemplary embodiments reference will be made to the use of insulin and GLP-1 containing drugs, this including analogues thereof as well as combinations with one or more other drugs.

BRIEF DESCRIPTION OF THE DRAWINGS

In the following the invention will be further described with reference to the drawings, wherein fig. 1 shows in cross-sectional view a patch device in combination with a drug delivery device provided with a shield unit, fig. 2 shows in a perspective view the shield unit with the shield retracted, and fig. 3 shows in cross-sectional view the patch and drug delivery devices of fig. 1 in a state of engagement.

In the figures like structures are mainly identified by like reference numerals.

DESCRIPTION OF EXEMPLARY EMBODIMENTS

When in the following terms such as “upper” and “lower”, “right” and “left”, “horizontal” and “vertical” or similar relative expressions are used, these only refer to the appended figures and not necessarily to an actual situation of use. The shown figures are schematic representations for which reason the configuration of the different structures as well as their relative dimensions are intended to serve illustrative purposes only. When the term member or element is used for a given component it generally indicates that in the described embodiment the component is a unitary component, however, the same member or element may alternatively comprise a number of sub-components just as two or more of the described components could be provided as unitary components, e.g. manufactured as a single injection moulded part. When it is de fined that members are mounted axially free to each other it generally indicates that they can be moved relative to each other, typically between defined stop positions whereas when it is defined that members are mounted rotationally free to each other it generally indicates that they can be rotated relative to each other either freely or between defined stop positions. The terms “assembly” and “subassembly” do not imply that the described components necessarily can be assembled to provide a unitary or functional assembly or subassembly during a given assembly procedure but is merely used to describe components grouped together as being functionally more closely related.

Referring to fig. 1 a patch device 100 and a therefor adapted pen-formed drug delivery device 150 are shown. The pen device comprises electronic circuitry adapted to detect and store data representing the size of an expelled amount of drug, e.g. as described in WO 2019/110494. The electronic circuitry may use the data to create and store a log comprising a plurality of detected dose amounts and associated time stamps. The electronic circuitry further comprises wireless communication means, e.g. Bluetooth® Low Energy (BLE), adapted for pairing with a patch device provided with corresponding wireless communication means. The wireless communication means is further adapted to transmit data stored in the memory to an external device. A processor is operatively connected to the detection means, the wireless communi cation means and the memory. In the shown embodiment the patch device is provided with sensor means on the catheter outer wall, e.g. for sensing blood glucose (BG) values.

In the shown embodiment the pen device 150 is provided with a shield needle unit 160 adapted to fit on the standard pen interface for a replaceable subcutaneous needle unit. The shield needle unit comprises a body member 161 attached to the pen injector and provided with a pointed hollow needle 162 in flow communication with the pen drug cartridge through the car tridge septum 152. The needle distal portion 163 is covered by a spring-biased 164 protective shield 165 comprising a central portion 166 in which a biostatic chamber 167 comprising a rubber compound or sponge-like material soaked with a preservative is provided. In the initial and non-actuated state the pointed needle end 163 is positioned in the preservative ensuring biostatic conditions of the needle. When the protective shield is moved proximally to its re tracted position the needle distal end is exposed together with the central distal end of the shield needle unit body member 161, the latter comprising a pair of snap locking structures 168 protruding through a pair of openings in the retracted shield, see fig. 2. The snap locking structures are adapted to engage corresponding snap locking structures on the patch device to ensure proper and stable alignment between the two devices during drug injection. In the shown embodiment the shield needle unit is provided with a pair of galvanic contact points 169 adapted to engage corresponding contact structures on the patch device. The pen device con tact points may be “passive” (as shown) or may be “active” connected to the electronic circuitry in the pen device. The patch device comprises a base portion 101 having a mounting surface 102 with an adhe sive layer adapted to be mounted on a skin surface of a patient, a catheter 110, electronic circuitry 120, and a centrally arranged injection port 130 for the drug delivery device.

In the shown embodiment the catheter in combination with an insertion needle (not shown) projects from the mounting surface in an initial state as provided to the user and is adapted to be inserted subcutaneously as the patch device is mounted on a skin surface. Alternatively, the catheter may initially be arranged in a non-projecting position and be adapted to be intro duced subcutaneously after the mounting surface has been attached to a skin surface. The catheter 110 comprises a distal end 112 adapted to be arranged in a patient’s subcutaneous tissue and comprises a catheter lumen 113 (initially occupied by the insertion needle) having a distal opening, e.g. at the distal end of the catheter.

To provide an injection port the body member 101 comprises a central bore 105 in which a valve housing 131 with an elastomeric needle-penetratable septum member 232 is mounted, the septum member being provided with a valve head 234 which in an initial state engages a valve seat in the valve housing to provide a closed valve, the septum providing a seal to a small fluid chamber 135 in flow communication with the catheter lumen 113. The bore proximal end forms a socket 106 adapted to receive the pen distal end in a formfitting engagement. Additionally, the socket comprises snap locking means 108 adapted to engage the correspond ing snap locking means 168 on the shield needle unit. The patch device is further provided with electronic circuitry 120 comprising a memory, detections means adapted to detect a patch pairing state in which a drug delivery device has been connected to the fluid port, wireless communication means adapted for pairing with a drug delivery device provided with corre sponding wireless communication means. The wireless communication means is further adapted to transmit data stored in the memory to an external device. A processor is operatively connected to the detection means, the wireless communication means and the memory. In shown embodiment the detection means is in the form of a pair of galvanic contact structures 109 arranged in the receiving socket and is adapted to engage the corresponding contact points 169 on the shield needle unit.

Alternatively, the detection means may be adapted to detect a short-range signal from a drug delivery device, e.g. using NFC. The short-range signal is not intended for pairing or transmis sion of dose data but is merely used as an indicator for the presence of a drug delivery device in such close proximity to the fluid port that it can be assumed that a physical connection is intended. The NFC signal may be emitted from the drug delivery device e.g. when a dose is being expelled, this assuring to a high degree that the correct drug delivery device is paired with the patch device.

In a situation of use when the user intends to inject an amount of drug through the injection port, using a new pen for the first time, the user inserts the pen device 150 distal end in the patch device receiving port socket 106 whereby the spring-biased protective shield 165 is pushed proximally, this allowing the needle distal end 163 to penetrate the septum 132 and enter the fluid chamber 135 and the snap-locking means 168, 108 to engage each other, this providing that the electric contact structures 169, 109 are forced into galvanic contact with each other. When the user determines that the pen device has been firmly seated in the port the pen is ready for injection of a desired amount of a fluid drug formulation, e.g. an insulin formu lation. In the exemplary embodiment the pen device is of the spring-driven type, this allowing the user to set the desired dose prior to inserting the pen device into the socket and release the spring-driven expelling mechanism when the pen has properly snap-engaged the socket. When the desired dose has been fully injected the user simply removes the pen device by un snapping it from the socket, this allowing the protective shield to return to its distal position covering the needle distal end. From the user’s perspective a dose of drug has been injected, however, without any involvement from the user the two devices have been paired at the same time.

More specifically, when the pen device snapped into place and galvanic contact between the contact structures were established a patch pairing state was detected by the patch device electronic circuitry, this resulting in the patch device starting to request wireless pairing with potential “candidates”. The only intended candidate in the described set-up is the pen device currently connected to the patch device. In order to assure that the patch device will not pair with other pen devices in the vicinity (e.g. the user’s stock of un-used pens), the pen device is in a corresponding device pairing state allowing the pen device to reply to the pairing request from the patch device, i.e. the pen device is in a “pairable” state.

The pen device may enter the device pairing state in a number of ways. For example, in case the pen device contact points are “active” connected to the electronic circuitry in the pen de vice, the contact points when engaging the corresponding contacts on the patch device may serve to activate a pen device pairing state allowing the pen to reply to the patch device pairing request. Alternatively, the pairing request may be initiated by the pen device, the patch device in a patch pairing state allowing it to reply and pair. Alternatively, the pen device may be brought into a pairing state by means of other operations or activities. For example, the pen electronics may wake up and enter a pairing state when a dose is being set. In case the pen electronics is not adapted to detect dose setting the pen electronics may wake up by tapping the pen lightly against a surface. As a further alternative, the pen electronics may wake up and enter a pairing state when a dose is being expelled, or a specific pattern of operations may turn the pen into pairing state, e.g. pushing the release button for 3 seconds with no dose set.

In order to allow for proper pairing, the pen device may enter the pairing state for a given amount of time, this allowing, for example, that the pen device could pair within a window of time after the pen device has been removed from the patch device. When pairing has been established the pen device is ready to transmit dose data and the patch device is ready to receive dose data from the paired pen which subsequently can be transmitted to an external device such as the user’s smartphone.

A given pen may be adapted to be paired with more than one patch device (in addition to further other types of enabled devices) just as given patch device may be adapted to be paired with more than one pen device (in addition to further other types of enabled devices).

In the above situation of use a new hitherto un-paired pen device was attached to a hitherto un-paired patch device, however, a number of alternative use scenarios can be expected to take place.

For example, when a drug delivery device has been connected to the fluid port and a patch pairing state has been detected, a number of scenarios are possible, e.g. (1) the patch device has been paired with a first drug delivery device and will pair with a second pairable drug delivery device, the patch device being paired with the first and second drug delivery device at the same time (the patch device may un-pair from the first drug delivery device after a given amount of time with no (re-)connection being established), (2) the patch device has been paired with a first drug delivery device and will pair with a second pairable drug delivery device, the patch device un-pairing from the first drug delivery device, or (3) the patch device has been paired with one or more drug delivery devices and will start to re-establish connection with an already paired drug delivery device in device pairing state.

In the above description pairing of two devices have been described, this being the initial step to establish permission that the two devices can communicate with each other. Connection is a step after pairing in which a given device actively communicates with a device it has previ ously paired with. Normally a connection state is entered automatically after an initial pairing. In general Bluetooth® devices will automatically connect with paired devices that have their Bluetooth® turned on which would also imply that a given drug delivery device and a given patch device which have previously been paired would automatically connect (i.e. re-connect) when within wireless reach of each other. This may or may not be desirable.

For example, for a paired combination of a drug delivery device and a patch device both de vices may be designed to be always “on” advertising for re-connection to previously paired devices. This would allow the patch device to be automatically updated with dose log data from the drug delivery device irrespective of when and where drug was expelled. For example, if the patch device becomes in-operatable and the user has to inject a dose of drug using a subcutaneously needle, then when the patch device again becomes operatable, the dose would be automatically updated. However, in case a different person would use the drug de livery device, the patch device dose log would contain unrelated dose data which could be more confusing than missing dose data.

Correspondingly, the patch device may be operated to only re-connect when in the pairing state and to only allow dose log data to be stored having a time stamp corresponding to the time for the pairing state.

In the above-described embodiment the patch and pen devices were provided with dedicated corresponding detection means, however, a patch pairing state may be detected in a number of alternative ways.

For example, the patch device may be equipped with detection means adapted to detect the presence of a pen device without any special detection structures, e.g. a mechanical switch arranged in the socket, an optical switch arranged in the socket, ora (pressure) sensor adapted to detect a flow of injected fluid through the patch device.

In case the patch device is provided with sensor means, e.g. for sensing blood glucose (BG) values, the detected changes in the user’s blood glucose level could serve as an indicator for an injection having taken place corresponding to a patch pairing state, this resulting in the patch device entering a pairing state allowing it to pair with the pen device “responsible” for the change in BG level. Indeed, this would require that the pen device pairing window is still open. The request for pairing may originate from either the pen device or the patch device. As described above, the pen device contact points may be connected to the electronic circuitry in the pen device, this allowing the two devices to communicate with each other by a wired connection to thereby exchange data or to provide additional verification. Conceptually, this would allow all communication to take place by wired connection and fully dispense with wire less transfer of log data from the pen device to the patch device.

When in a given system dose log data and BG data is collected and stored it may be possible to use that data to provide dose guidance to the user. In an embodiment in which the patch device comprises a CGM sensor, all such data could be collected in the patch device which may then serve as a “hub” for making dose recommendation to the user via the pen device without involving an additional device such as the user’s smartphone. Dose calculations and data handling may take place in the patch device or may be received from an external device, e.g. the patient’s smartphone or from “the cloud”. Alternatively, all data handling and calcula tions could take place in the patch device. In the latter case the patch device would have to rely on CGM data for a given amount of time, data that may be lost in case a given CGM patch device is replaced. However, in case of a two unit system in which a disposable skin-mountable unit comprising the catheter and the CGM sensor is used in combination with a reusable elec tronics unit, this issue could be overcome as previous CGM data remains stored in the memory of the reusable unit.

In a relatively simple set-up the patch device would communicate to a (single) paired injection (pen) device and provide a dose recommendation on an injection device display. The user would then set the recommended dose and inject it through the patch device port. On a more advanced level the injection device may be in the form of a motor driven drug delivery device, this allowing the patch device to control the delivery device and set a dose. The dose setting command may be transmitted wirelessly to a given paired device, however, to enhance user safety the delivery device may be required to be mounted in the patch device socket, this allowing the delivery device to detect a docked state and thereby in a state allowing dose setting to be controlled by the patch. The docking may also allow the patch electronic circuitry to connect with the delivery device electronic circuitry allowing a further verification to be intro duced by secondary communication through the electric connection between the two units through the connectors. To further enhance user safety injection of the automatically set dose size may require the delivery device to remain in the docked state, e.g. removing the delivery device from the socket will abort the process and the set dose will be cancelled. When in the docked state actuation of the motorized expelling mechanism may be controlled by the user or the patch device electronic circuitry.

In an embodiment functionally similar to the above-described “controlled pen” embodiment, the pen device has been replaced with a pump-like unit adapted to be attached to the patch device for an extended period of time, e.g. until the cartridge or reservoir is empty, the battery has to be recharged or the patch device has to be replaced. In this way a fully-automated skin- mountable infusion pump with integrated CGM is provided. In the above description of exemplary embodiments, the different structures and means provid ing the described functionality for the different components have been described to a degree to which the concept of the present invention will be apparent to the skilled reader. The detailed construction and specification for the different components are considered the object of a nor mal design procedure performed by the skilled person along the lines set out in the present specification.

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Claims

1. A patch device (100) comprising: a base portion (101) having a mounting surface (102) adapted to be mounted on a skin surface of a patient, a fluid outlet (113) allowing a fluid to be delivered subcutaneously when the patch device is mounted on a skin surface of a patient, a fluid port (106, 132) in flow communication with the fluid outlet and adapted to re ceive an outlet of a drug delivery device (150), electronic circuitry (120) comprising: a memory, detections means (109) adapted to detect a patch pairing state in which a drug delivery device has been connected to the patch device and/or that a fluid is being injected through the fluid port, wireless communication means adapted for pairing with a drug delivery de vice provided with corresponding wireless communication means, the wireless com munication means being further adapted to transmit data stored in the memory to an external device, and a processor operatively connected to the detection means, the wireless communication means and the memory, wherein: when a patch pairing state is detected the wireless communication means is oper ated to provide pairing with a pairable drug delivery device (150) in a given predefined device pairing state, and when a pairing between the patch device and a drug delivery device has been es tablished, dose data can be received from the drug delivery device and stored in the memory for subsequent transmission to the external device.

2. A patch device as in claim 1 , wherein a pairing process is initiated by the patch de vice when a patch pairing state has been detected.

3. A patch device as in claim 2, wherein pairing is established with a given drug deliv ery device when in the pairing process data is received from the drug delivery device indicating that the drug delivery device within a given time range from the time of detection of the patch pairing state has been operated by a user to set or expel an amount of drug.

4. A patch device as in claim 1 , wherein the patch device is responsive to a pairing re quest from a drug delivery device when a patch pairing state has been detected.

5. A patch device as in claim 4, wherein pairing is established with the requesting drug delivery device when in the pairing process data is received from the drug delivery device in dicating that the drug delivery device within a given time range from the time of detection of the patch pairing state has been operated by a user to set or expel an amount of drug.

6. A patch device as in any of claims 1-5, wherein the patch device is able to be paired with more than one drug delivery device at any given time.

7. A patch device as in any of claims 1-6, wherein: when a patch pairing state is detected the wireless communication means is oper ated to re-establish connection with an already paired drug delivery device.

8. A patch device as in any of claims 1-7, further comprising: a sensor (121) adapted to generate a signal indicative of a parameter value of a body fluid, the sensor being adapted to be arranged subcutaneously when the patch device is mounted on a skin surface of a patient, wherein the processor is operatively connected to the sensor for transferring measu ring data based on sensor signals to an external receiver via the wireless communication means.

9. A patch device as in claim 8, wherein the sensor is a CGM sensor.

10. A patch device as in claim 4 or 5 in combination with a drug delivery device compris ing corresponding wireless communication means, wherein: the drug delivery device comprises detections means adapted to detect a device pairing state in which the drug delivery device has been connected to the fluid port, and when a device pairing state is detected the wireless communication means is oper ated to provide pairing with the patch device.

11. A patch device as in any of claims 1-10, in combination with a drug delivery device (150), the drug delivery device comprising a distal end portion with a drug outlet (163) adapted to be arranged in fluid communication with the catheter lumen via the fluid port (106, 132).

12. A patch device in combination with a drug delivery device as in claim 11 , wherein the fluid port and the end portion are adapted to engage each other in a form fitting relationship securing a predetermined orientation of the drug delivery device rela tive to the base portion.

13. A patch device in combination with a drug delivery device as in claim 11 or 12, wherein the external fluid port and the end portion prior to engagement comprise no user-vis ible needle.

14. A patch device in combination with a drug delivery device as in claim 13, wherein the external fluid port comprises an initially hidden pointed hollow needle (131) and the drug outlet (152) comprises a needle-penetratable septum.

15. A patch device in combination with a drug delivery device as in claim 13, wherein the drug outlet comprises an initially hidden pointed hollow needle (162) and the external fluid port comprises a needle-penetratable septum (132).

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