Combined analyte sensor and infusion set

Abstract

Disclosed herein are modular devices and methods of manufacturing such modular devices. The modular devices disclosed herein include: an analyte sensor comprising a sensor probe; an infusion needle hub comprising a cannula; and a flexible base. The analyte sensor and infusion needle hub are attached to the flexible base such that movement of one of the analyte sensor and the infusion needle hub is not substantially transmitted to the other.

Description

Technical Field

[0001]

[0014] Embodiments of the subject matter described herein generally relate to a combined device comprising an analyte sensor and an infusion set hub. Background Art

[0002] Glucose is one of the main sources of energy for cells that make up muscle and other tissues. Glucose is absorbed into the bloodstream, where it enters cells with the help of insulin. Some people with diabetes experience a chronic condition in which the pancreas produces little or no insulin, reducing glucose uptake by cells. Therefore, unless a person takes steps to control their high blood sugar, blood sugar levels will remain high. If not properly managed, the effects of diabetes can become medically serious.

[0003] One way to manage this insulin deficiency is through the use of an insulin pump. An insulin pump is a device that allows insulin to be delivered to the user. This insulin is typically delivered subcutaneously under the user's skin.

[0004] The amount of insulin and the timing of insulin delivery are typically determined based on the user's glucose level. For example, if a user has a high blood sugar concentration at a particular time that is outside a predetermined threshold level for the user, insulin may be delivered to the user via an insulin infusion set worn on the user's body.

[0005] A continuous analyte sensor, such as a continuous glucose sensor, that can be worn on the user's body can be used to monitor a user's glucose concentration level. A continuous glucose sensor monitors glucose levels in the user's interstitial fluid (ISF) over an extended period of time, typically by periodically obtaining blood glucose concentration readings via finger pricking. ISF glucose has a 5- to 10-minute delay in responding to changes in blood glucose. Glucose readings on ISF have been shown to reliably reflect glucose levels.

[0006] It is desirable to improve user comfort when wearing glucose sensors and infusion sets on the body.

[0007] Furthermore, other desirable features and characteristics will become apparent from the subsequent detailed description and the appended claims, taken in conjunction with the accompanying drawings and the foregoing technical field and background. Summary of the Invention

[0008] This Summary is provided to introduce in simplified form a series of concepts that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential characteristics of the claimed subject matter, nor is it intended to be used as a tool for determining the scope of the claimed subject matter. Although most of the inventive concepts discussed herein will be described with respect to glucose sensors and insulin infusion needle hubs, it should be understood that these concepts are also applicable to other types of analyte sensors and infusion needle hubs.

[0009] According to an exemplary embodiment, a combined device is provided. The combined device includes an analyte sensor. In various embodiments, the analyte sensor is a single-use, disposable sensing assembly that is designed to be used with a portable potentiostat device that can record data and / or transmit data to a monitor (for example, a glucose sensor can transmit data to an insulin pump) or alternatively used with a recording device for retrospective sensor evaluation. The combined device includes an infusion set needle seat. The infusion set needle seat includes a cannula through which fluid to be infused (such as insulin) can be delivered from a drug reservoir by a pump. The combined device also includes a flexible base. The effect of mounting the analyte sensor and the infusion set needle seat on the flexible base is that the movement of one component (i.e., the movement of the analyte sensor or the movement of the infusion set needle seat) does not result in significant movement of the other component (i.e., the other of the infusion set needle seat or the analyte sensor).

[0010] According to a second exemplary embodiment, a method of manufacturing a modular device is provided, comprising the steps of providing a flexible base, attaching an infusion set needle hub to the flexible base, and attaching an analyte sensor to the flexible base. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] A more complete understanding of the subject matter may be derived by referring to the detailed description and claims when considered in conjunction with the following drawings, wherein like reference numerals refer to like elements throughout.

[0012] Figure 1 is a schematic diagram of a combined analyte sensor and infusion device needle hub assembly;

[0013] Figure 2 is a schematic diagram of a combined analyte sensor and infusion set needle hub assembly according to an exemplary embodiment;

[0014] Figure 3 is an isometric side view of a modular device according to an exemplary embodiment;

[0015] Figure 4 is a schematic diagram of another combined device according to an exemplary embodiment;

[0016] Figure 5 is an isometric view of a modular device positioned on a user's body according to an exemplary embodiment;

[0017] Figure 6 is an isometric view of a connector for use with a modular device according to an exemplary embodiment;

[0018] Figure 7 is another isometric view of a modular device according to an exemplary embodiment;

[0019] Figure 8 An infusion set needle hub for stress / strain simulation according to an exemplary embodiment is shown;

[0020] Figure 9 Shown Figure 8 The stress / strain simulation results of the infusion needle seat;

[0021] Figure 10 and 11 shows a further view of an infusion set needle hub used in a stress / strain simulation according to an exemplary embodiment; and

[0022] Figure 12 A flow chart depicting a method of manufacturing a modular device according to an exemplary embodiment is shown. DETAILED DESCRIPTION

[0023] The following specific examples are merely illustrative in nature and are not intended to limit the present subject matter or the embodiments of the present application or the application and use of such embodiments. As used herein, the word "exemplary" means "serving as an example, instance, or illustration." Any embodiment described herein as exemplary is not necessarily to be construed as superior to or preferred over other embodiments. Furthermore, no one is intended to be bound by any theory expressed or implied in the foregoing technical field, background, summary, or the following detailed description.

[0024] Combining a continuous analyte sensor, such as a glucose sensor, and an infusion set, such as an insulin infusion set, into one device reduces the number of locations on the user's body that must be "managed" by the user during showering, exercising, etc. The combined device therefore requires less user management, thereby improving the user experience of wearing the analyte sensor and infusion set hub.

[0025] After extensive research, the present inventors have recognized several disadvantages associated with combined analyte sensor / infusion needle hub devices. One of these disadvantages is referred to as Figure 1 Provide explanation.

[0026] Figure 1A schematic diagram of a combined analyte sensor / infusion set 100 (hereinafter referred to as the "combination set") is shown. The combination set 100 includes a glucose sensor 102 and an insulin infusion set needle hub 106 fixedly attached to each other. The glucose sensor 102 includes a sensor probe 104. The sensor probe 104 is an intradermal probe that, when installed, is configured to be partially positioned beneath the user's skin to allow electrochemical sensing of the user's glucose concentration in the interstitial fluid. The insulin infusion set needle hub 106 includes a cannula 108 that is configured to provide a passage from the insulin reservoir to the user's tissue so that insulin can be delivered through the cannula 108.

[0027] The glucose sensor 102 and the insulin infusion needle hub 106 are both attached to a solid base 110, with the sensor probe 104 and the cannula 108 protruding through the solid base 110. In use, the solid base 110 can be secured to the user's skin by an adhesive, a bandage, etc., with the sensor probe 104 and the cannula 108 positioned intradermally on the user's skin. The user's glucose concentration is monitored by the glucose sensor 102 of the combination device 100, and when necessary, the insulin infusion needle hub 106 of the combination device 100 is used to deliver insulin to the user to adjust the user's glucose concentration to a desired level.

[0028] A problem with this type of modular device 100 is that the fixed attachment between solid base 110 and glucose sensor 102 and insulin infusion set needle holder 106 contributes to a "seesaw" effect during or after the intradermal installation of sensor probe 104 and cannula 108 on the user. More specifically, the vertical or horizontal movement (no matter whether this movement is intentional or accidental) of insulin infusion set needle holder 106 causes the resulting corresponding displacement of the point near the center of glucose sensor 102 around the modular device 100, and vice versa, which may be problematic. In use, sensor probe 104 (and cannula 108 to a lesser extent) should ideally be positioned in substantially the same position in the user's tissue from installation to the entire subsequent use. For example, this constant position, for example, allows during the "calibration phase" of glucose sensor 102, accurately calibrating sensor probe for the specific location. However, due to the fixed attachment between the glucose sensor 102 and the insulin infusion set needle hub 106 and / or the attachment of each of the glucose sensor 102 and the insulin infusion set needle hub 106 to the solid base 110, the "seesaw" effect described above causes the sensor probe 104 and / or cannula 108 to undesirably move to new, uncalibrated positions.

[0029] To overcome this problem, exemplary embodiments provide a combined device in which this "seesaw" effect is reduced.

[0030] Figure 2 A schematic diagram of a combined device 200 according to an exemplary embodiment is shown. Figure 2 As can be seen in FIG, the combined device 200 includes a glucose sensor 202 and an insulin infusion device needle seat 206, wherein the glucose sensor includes a sensor probe 204, and the insulin infusion device needle seat includes a cannula 208. The glucose sensor 202 and the insulin infusion device needle seat 206 are arranged to be close to each other on a flexible base 210. In one embodiment, the glucose sensor 202 and the insulin infusion device needle seat 206 are not attached to each other, and are only attached to the flexible base 210, so that the movement of one of these devices will not cause the significant movement of the other device. Specifically, because the base 210 is flexible, the movement of one of the devices attached to the flexible base will not cause a "seesaw" effect. In an alternative exemplary embodiment, the glucose sensor 202 and the insulin infusion device needle seat 206 are connected to each other by a joint, which allows the horizontal and vertical displacement of any one of these devices without causing opposite displacement in the other device, as will be described in more detail below.

[0031] Since the glucose sensor 202 and the insulin infusion set needle hub 206 are attached only to the flexible base 210 and not fixedly attached to each other, or by attaching the glucose sensor 202 and the insulin infusion set needle hub 206 to each other in a manner that allows horizontal and vertical displacement of any of these devices without causing significant opposite displacement in the other device (e.g., through a joint), a significant mechanical isolation is caused between the glucose sensor 202 and the insulin infusion set needle hub 206. Any accidental or intentional movement of one device will have essentially no effect on the position of the other device. Therefore, the possibility of undesirable movement of the sensor probe 204 or the cannula 208 is reduced. Due to this reduced possibility of undesirable movement of the sensor probe, the high level of accuracy of the sensor probe 204 can be maintained throughout its operating life. Specifically, since the calibration process of the sensor probe 204 occurs when the installed sensor probe 204 is in a specific position, the movement of the sensor probe 204 from the position will reduce the accuracy of the reading of the glucose sensor 202, and retaining the sensor probe 204 in the same position maintains a high level of accuracy.

[0032] Figure 3 An isometric view of a modular device 300 is shown according to an exemplary embodiment. Figure 3, the combined device includes a glucose sensor 302 attached to a flexible base 310, wherein the glucose sensor 302 includes a sensor probe 304. In various exemplary embodiments, the glucose sensor 302 is attached to the flexible base 310 by welding. In alternative exemplary embodiments, the glucose sensor 302 is attached to the flexible base 310 by another attachment means, such as by an adhesive, by stitching, by seam welding, etc.

[0033] In an exemplary embodiment, glucose sensor 302 includes a transmitter 320 configured to transmit a sensed glucose concentration value from glucose sensor 302 to insulin infusion set hub 306. In one exemplary embodiment, transmitter 320 is configured to wirelessly transmit the sensed glucose concentration value to a pump that controls the flow of insulin through infusion set hub 306. In an alternative exemplary embodiment, transmitter 320 is configured to transmit the sensed glucose concentration value to the pump through the insulin infusion set hub via a wired connection.

[0034] like Figure 3 As shown, in an exemplary embodiment, the sensor probe 304 is angled relative to the flexible base. The angle of the sensor probe 304 is selected so that the tip 305 of the sensor probe 304 will be located in the user's interstitial tissue when installed in the user's body. This allows for electrochemical measurement of the user's interstitial fluid glucose concentration, which is indicative of the user's blood glucose concentration.

[0035] The modular device 300 further includes an insulin infusion set needle hub 306 attached to a flexible base 310, wherein the insulin infusion set needle hub 306 includes a cannula 308. In various exemplary embodiments, the insulin infusion set needle hub 306 is attached to the flexible base 310 by welding. In alternative exemplary embodiments, the insulin infusion set needle hub 306 is attached to the flexible base 310 by another attachment means, such as by an adhesive, by suturing, by seam welding, etc.

[0036] The flexible base 310 may include a backing material made, for example, of one or more of the following: spunlace polyester nonwoven fabric, polyurethane blown film nonwoven fabric, polyethylene nonwoven fabric, polypropylene nonwoven fabric. A suitable thickness of the backing material is any value in the range of 76 microns to 381 microns (0.003" to 0.015"). A preferred thickness is in the range of 203 microns to 254 microns (0.008" to 0.010"). In addition, the flexible base 310 may include an adhesive layer, preferably an acrylic-based pressure-sensitive adhesive. A suitable thickness of the adhesive layer is 51 microns to 254 microns (0.002" to 0.010"), with a preferred thickness in the range of 76 microns to 127 microns (0.003" to 0.005"). The purpose of the adhesive layer is to attach the flexible base to the user's body. The flexible base may also have a removable liner to protect the adhesive before it is applied to the user's body. The liner may comprise a polymer-coated bleached kraft paper having a silicone release layer on one side adjacent to the adhesive layer. Suitable thicknesses for the liner are anywhere in the range of 102 to 381 microns (0.004" to 0.015"), with a preferred range of 102 to 203 microns (0.004" to 0.008").

[0037] Figure 3 The glucose sensor 302 and the insulin infusion set needle hub 306 are connected to each other via a connector 350. The connector 350 is configured to allow two-dimensional movement of either the glucose sensor 302 or the insulin infusion set needle hub 306 without transmitting the movement to the other of the glucose sensor 302 or the insulin infusion set needle hub 306. In other words, the connector 350 is configured to substantially isolate the glucose sensor 302 from movement of the insulin infusion set needle hub 306, and vice versa.

[0038] In one exemplary embodiment, the connector 350 comprises complementary angled portions of the housings of the glucose sensor 302 and the insulin infusion set hub 306 such that movement of either the glucose sensor 302 or the insulin infusion set hub 306 is not transferred to the other of the glucose sensor and the insulin infusion set hub 306. In an alternative exemplary embodiment, the connector 350 comprises a ball and socket joint.

[0039] In a preferred embodiment, the connector 350 is configured to allow for a releasable attachment between the glucose sensor 302 and the insulin infusion set hub 306. In this manner, the modular device 300 can be made modular in nature, such that either the glucose sensor 302 or the insulin infusion set hub 306 can be replaced without having to replace the entire modular device 300. It should be understood that a modular configuration can also be achieved when the glucose sensor 302 is not connected to the insulin infusion set hub.

[0040] By making the modular device 300 modular in nature, the ease of use and user comfort of the modular device 300 are improved. Specifically, if either the glucose sensor 302 or the insulin infusion needle hub 306 does not function upon installation, or fails during subsequent use, that particular component of the modular device 300 can be replaced without having to replace other components of the modular device. This reduces the total number of sensor probes 304 and cannulas 308 installations required.

[0041] A variety of techniques are contemplated for making the modular device 300 modular in nature. In a first exemplary embodiment, each of the glucose sensor 302 and the insulin infusion set needle hub 306 is directly attached to the flexible base 310 with an adhesive and mechanically isolated from each other. In this manner, a user can simply apply force to either the glucose sensor 302 or the insulin infusion set needle hub 306 to mechanically separate either component from the flexible base 310. A replacement glucose sensor 302 or insulin infusion set needle hub 306 can then be installed by attaching the replacement component to the flexible base 310 with an adhesive.

[0042] In another exemplary embodiment, each of the glucose sensor 302 and the insulin infusion set needle hub 306 is directly attached to the flexible base 310 with an adhesive and is releasably connected via a connector 350. To replace either the glucose sensor 302 or the insulin infusion set needle hub 306, a user can apply force to the component to be replaced, thereby mechanically separating the component from the base 310 and simultaneously releasing the component from the connector 350. A replacement glucose sensor 302 or insulin infusion set needle hub 306 can then be installed by attaching the replacement component to the flexible base 310 with an adhesive and simultaneously forming the connector 350.

[0043] In an exemplary embodiment, Figure 4Schematically, each of the glucose sensor 302 and the insulin infusion set needle hub 306 is permanently attached to a corresponding first connector 360 and a second connector 370, for example, by sewing or welding. The first connector 360 and the second connector 370 are releasably attached to the flexible base 310, for example, by an adhesive. In an exemplary embodiment, the first connector 360 and the second connector 370 are connected to the flexible base 310 by an adhesive. In this way, a user can apply force to one of the first connector 360 and the second connector 370 to separate the connector and the component attached to the connector (glucose sensor 302 or insulin infusion set needle hub 306) from the flexible base 310. To help the user separate the connectors 360, 370 from the flexible base 310, in an exemplary embodiment, the connectors 360, 370 are shaped to have a protrusion that the user can grasp and pull when separating the connectors from the flexible base 310. In an exemplary embodiment, the first connector 360 and the second connector 370 are formed from a single piece of material, wherein a perforation 380 is formed between the first connector 360 and the second connector 370, thereby allowing the first connector 360 and the second connector 370 to be pulled apart by a user when replacing one of the glucose sensor 302 and the insulin infusion set needle hub 306.

[0044] The present inventors have determined that by allowing modular replacement of the glucose sensor 302 and the insulin infusion set needle hub 306, the overall lifespan and reliability of the combined device 300 can be increased.

[0045] return Figure 3 , it can be seen that the sensor probe 304 is positioned in close proximity to the cannula 308 of the insulin infusion set hub 306. It should be understood that positioning the sensor probe 304 relatively close to the cannula 308 is a necessary condition for forming a combined device 300 in which the glucose sensor 302 and the insulin infusion set hub 306 are positioned at the same location on the user's body.

[0046] The present inventors have recognized the potential problems of positioning the sensor probe 304 of the glucose sensor 302 relatively close to the cannula 308. Specifically, when insulin is delivered to the user's tissue through the cannula 308, the local insulin concentration increases. Due to the presence of other components in the insulin formulation that affect the chemical properties of the glucose sensor (e.g., preservatives and surfactants), this increase in local insulin concentration increases the likelihood that the sensor reading will be incorrect. If the sensor probe 304 is also placed in this local area, the glucose sensor 302 will therefore be more likely to unfavorably detect an incorrect glucose concentration, thereby resulting in an incorrect total glucose concentration reading for the user (this phenomenon is hereinafter referred to as "crosstalk").

[0047] To investigate how to mitigate the effects of such crosstalk, the inventors investigated the minimum distance between the sensor probe 304 and the cannula 308. Based on the results of this investigation, it was determined that a distance of at least 5 mm between the sensor probe 304 and the cannula 308 is required to sufficiently reduce the effects of crosstalk, such as a distance between approximately 5 mm and approximately 20 mm. Preferably, a distance of at least 10 mm between the cannula 308 and the sensor probe 304 is present to reduce the effects of crosstalk, such as a distance between approximately 10 mm and approximately 15 mm. For example, a distance of approximately 13 mm between the cannula 308 and the sensor probe 304 allows for reduced crosstalk effects while also ensuring that the overall modular device remains sufficiently compact for user comfort.

[0048] Now go to Figure 5 , shows another isometric view of the combined device 300, wherein the combined device 300 is mounted on a portion of the user's body 10. As described above, the combined device 300 includes a glucose sensor 302 having a transmitter 320. Figure 5 In the illustrated embodiment, the transmitter 320 is a wireless transmitter configured to wirelessly transmit the sensed ISF glucose concentration level. The combined device 300 further includes an insulin infusion needle hub 306. The insulin infusion needle hub 306 is connected to a connector 400 via an insulin delivery tube 390. The connector 400 is configured to releasably connect the insulin delivery tube 390 to an insulin pump and a reservoir 500.

[0049] In use, glucose sensor 302 senses the user's glucose concentration and wirelessly transmits this value to a user device (e.g., pump 500) for display to the user. When the user's glucose concentration meets certain criteria (e.g., exceeds a predetermined threshold), pump 500 is then operated (by the user or automatically) to administer insulin to the user through insulin delivery tube 390 and the cannula.

[0050] A "quick fit" connector is used to connect the insulin delivery tubing 390 to a drug reservoir, which is typically located inside the pump 500. In one exemplary embodiment, the connector 400 comprises an integral H-cap connector. Figure 6 Such a connector is shown. The H-cap connector 400 allows the pump 500 to be quickly connected and disconnected from the insulin delivery tube 390 and also reduces the possibility of leaks from this connection. In addition, the H-cap connector 400 includes an inline filter and two PVA foams that, along with the low preservative loss tubing, allow clean insulin to pass through the infusion set fluid path and be infused through the cannula for a period of up to seven days.

[0051] Now go to Figure 7 , shows an isometric view of an exemplary embodiment of a combined device 300. As shown in the exemplary embodiment Figure 7 As can be seen in the figure, the vertical profile of the insulin infusion set needle hub 306 is reduced to reduce the likelihood of the modular device 300 "catching" on the user's clothing. Preferably, the maximum vertical dimension of the modular device, defined herein as the distance from the bottom of the flexible base to the end of the modular device that is furthest from the bottom of the flexible device in the vertical direction, is less than about 2 cm, preferably about 1 cm.

[0052] Notably, the design of the combined device reduces the likelihood of leakage during insulin delivery. Figure 8 、 9 , 10 and 11 show simulation designs and results for modular devices according to embodiments of the present invention. Specifically, the simulation results show that for the modular device designs disclosed herein, typical stress values ​​caused by normal use of the modular device (such as stress caused by daily wear of the modular device and / or insertion of a cannula into the septum 800 of the infusion set) will not be sufficient to cause leakage, even when the maximum vertical dimension of the modular device is limited to approximately 1 cm. It was previously believed that infusion set needle hubs with limited vertical dimensions were prone to leakage. However, as shown in Figure 9 As can be seen in Figure 9, an infusion needle hub of a modular device with this restricted vertical dimension was tested under varying amounts of uniaxial stress (line 901), biaxial stress (line 902), and shear stress (line 903). The resulting strain resulting from each of these applied stresses was measured. Based on these stress / strain results, it was determined that typical stresses generated by daily use of the modular device would not produce strains that could cause leakage. In the simulation, the infusion needle hub material was selected to be polycarbonate, and the diaphragm material inside the infusion needle hub was selected to be rubber.

[0053] Go to Figure 12 , a flowchart is provided in the form of a method (S1200) for manufacturing a modular device according to an exemplary embodiment. At step S1201, a flexible base is provided. The flexible base 310 described above has a sufficiently low Young's modulus such that movement of a first portion of the base does not substantially cause movement of a second portion of the base away from the first portion. After providing the flexible base, the method proceeds to step S1202.

[0054] At step S1202, the insulin infusion set needle hub is attached to a flexible base. In an exemplary embodiment, the insulin infusion set needle hub is welded to the flexible base, and the cannula of the insulin infusion set needle hub is configured to protrude through the flexible base. After the insulin infusion set needle hub is attached to the flexible base, the method proceeds to step S803. In another exemplary embodiment, the insulin infusion set needle hub is attached to the flexible base using an adhesive.

[0055] At step S1203, the glucose sensor is attached to the flexible base. In one exemplary embodiment, the glucose sensor is welded to the flexible base, and the sensor probe of the glucose sensor is configured to protrude through the flexible base. In another exemplary embodiment, the glucose sensor is attached to the flexible base using an adhesive.

[0056] For the sake of completeness, it should be understood that the order in which steps S1202 and S1203 are performed may be reversed if desired.

[0057] Techniques and techniques may be described herein in terms of functional and / or logical block components, with reference to symbolic representations of operations, processing tasks, and functions that may be performed by various computing components or devices. Such operations, tasks, and functions are sometimes referred to as being computer-executed, computerized, software-implemented, or computer-implemented. It should be understood that the various block components shown in the figures may be implemented by any number of hardware, software, and / or firmware components configured to perform the specified functions. For example, an embodiment of the insertion device may include a computerized or mechanized component for adjusting the force used when installing an infusion needle hub, which may employ various integrated circuit components, such as memory elements, digital signal processing elements, logic elements, lookup tables, etc., which may perform a variety of functions under the control of one or more microprocessors or other control devices.

[0058] In addition, certain terms may be used in the following description for reference purposes only, and thus these terms are not intended to be limiting. For example, terms such as "upper," "lower," "above," and "below" may be used to refer to directions in the accompanying drawings with reference to them. Terms such as "front," "rear," "back," "side," "outside," and "inside" describe the direction and / or position of parts of a component within a consistent but arbitrary framework, which is made clear by reference to the text and related drawings describing the component in question. Such terms may include the words specifically mentioned above, their derivatives, and words of similar meaning. Similarly, the terms "first," "second," and other such numerical terms referring to structures do not imply a sequence or order unless clearly indicated by the context.

[0059] For the sake of brevity, conventional techniques related to biosensor probe manufacturing may not be described in detail herein. In addition, the connecting lines shown in the various figures contained herein are intended to represent exemplary functional relationships and / or physical connections between the various elements. It should be noted that alternative or additional functional relationships or physical connections may exist in the embodiments of the subject matter.

[0060] Although at least one exemplary embodiment has been presented in the foregoing detailed description, it should be understood that there are a large number of variations. It should also be understood that one or more exemplary embodiments described herein are not intended to limit the scope, applicability, or configuration of the claimed subject matter in any way. More precisely, the foregoing detailed description will provide a convenient guide for implementing the one or more described embodiments to those skilled in the art. It should be understood that various changes may be made to the function and arrangement of elements without departing from the scope defined by the claims, and the changes are included in equivalents or foreseeable equivalents known at the time of filing this patent application.

Claims

1. A combined device (200, 300), comprising: an analyte sensor (202, 302), the analyte sensor (202, 302) comprising a sensor probe (204, 304); an infusion set needle hub (206, 306), the infusion set needle hub (206, 306) including a cannula (208, 308); and A flexible base, wherein the analyte sensor (202, 302) and the infusion set needle hub (206, 306) are indirectly attached to the flexible base (210, 310) via a monolithic material comprising a first connector (360), a second connector (370), and a perforation (380) formed between the first connector and the second connector, and wherein the analyte sensor (202, 302) is permanently attached to one of the first connector (360) and the second connector (370) and the infusion set needle hub (206, 306) is permanently attached to the other of the first connector (360) and the second connector (370) such that movement of one of the analyte sensor (202, 302) and the infusion set needle hub (206, 306) does not cause movement of the other of the analyte sensor (202, 302) and the infusion set needle hub (206, 306).

2. The combined device (200, 300) of claim 1, wherein the analyte sensor (202, 302) and the infusion set needle hub (206, 306) are each releasably attached to the flexible base (210, 310).

3. The combined device (200, 300) of claim 1, wherein the analyte sensor (202, 302) comprises a transmitter (320) configured to transmit the sensed analyte concentration value to a user device.

4. The combined device (200, 300) according to any one of claims 1 to 3, wherein the sensor probe (204, 304) and the cannula (208, 308) are spaced apart from each other by a distance of at least 5 mm.

5. The combined device (200, 300) of claim 4, wherein the sensor probe (204, 304) and the cannula (208, 308) are spaced apart from each other by a distance of at least 10 mm.

6. The combined device (200, 300) of claim 5, wherein the sensor probe (204, 304) and the cannula (208, 308) are spaced apart from each other by a distance of 13 mm.

7. The combined device (200, 300) of any one of claims 1 to 3, wherein the infusion set needle hub (206, 306) is an insulin infusion set needle hub (206, 306) and includes an insulin delivery tube (390) and a connector (400) configured to connect the insulin delivery tube (390) to an insulin pump (500), and wherein the analyte sensor (202, 302) includes a glucose sensor.

8. The modular device (200, 300) of claim 7, wherein the connector (400) comprises an H-hat connector.

9. The combined device (200, 300) according to any one of claims 1 to 3, wherein the maximum vertical dimension of the combined device (200, 300) is 2 cm.

10. The combined device (200, 300) according to any one of claims 1 to 3, wherein the flexible base comprises a backing material made of one or more of the following: spunlace polyester nonwoven fabric, polyurethane blown film nonwoven fabric, polyethylene nonwoven fabric, polypropylene nonwoven fabric.

11. The combined device (200, 300) of claim 10, wherein the backing material has a thickness in the range of 76 microns to 381 microns.

12. The combined device (200, 300) of claim 11, wherein the backing material has a thickness in the range of 203 microns to 254 microns.

13. The combined device (200, 300) according to any one of claims 1 to 3, wherein the flexible base (210, 310) further comprises an adhesive layer for attaching the flexible base to a user's body, wherein the adhesive layer comprises an acrylic-based pressure sensitive adhesive.

14. The combined device (200, 300) of claim 13, wherein the thickness of the adhesive layer is in the range of 51 microns to 254 microns.

15. The combined device (200, 300) of claim 14, wherein the adhesive layer has a thickness in the range of 76 microns to 127 microns.

16. A method of manufacturing a modular device (200, 300), the method comprising: Providing a flexible base (210, 310); attaching an infusion set needle hub (206, 306) to the flexible base (210, 310); and attaching an analyte sensor (202, 302) to the flexible base (210, 310), The method further includes the step of indirectly attaching the analyte sensor (202, 302) and the infusion set needle hub (206, 306) to the flexible base (210, 310) via an integral material comprising a first connector (360), a second connector (370) and a perforation (380) formed between the first connector and the second connector, and wherein the analyte sensor (202, 302) is permanently attached to one of the first connector (360) and the second connector (370) and the infusion set needle hub (206, 306) is permanently attached to the other of the first connector (360) and the second connector (370) such that movement of one of the analyte sensor (202, 302) and the infusion set needle hub (206, 306) does not cause movement of the other of the analyte sensor (202, 302) and the infusion set needle hub (206, 306).

17. The method of claim 16, wherein the analyte sensor (202, 302) and the infusion set needle hub (206, 306) are each releasably attached to the flexible base (210, 310).

18. The method of claim 16, wherein the infusion needle hub (206, 306) includes a cannula (208, 308), and wherein the analyte sensor (202, 302) includes a sensor probe (204, 304), and wherein the attachment of the infusion needle hub (206, 306) and the analyte sensor (202, 302) to the flexible base (210, 310) is such that the sensor probe (204, 304) and the cannula (208, 308) are spaced a distance of at least 5 mm from one another.

19. The method of claim 18, wherein the attachment of the infusion set needle hub (206, 306) and the analyte sensor (202, 302) to the flexible base (210, 310) causes the sensor probe (204, 304) and the cannula (208, 308) to be spaced at a distance of at least 10 mm from each other.

20. The method of claim 19, wherein the attachment of the infusion set needle hub (206, 306) and the analyte sensor (202, 302) to the flexible base (210, 310) causes the sensor probe (204, 304) and the cannula (208, 308) to be spaced a distance of 13 mm from one another.

21. The method of any one of claims 16 to 20, wherein the flexible base comprises a backing material made from one or more of the following: spunlace polyester nonwoven fabric, polyurethane blown film nonwoven fabric, polyethylene nonwoven fabric, polypropylene nonwoven fabric.

22. The method of claim 21, wherein the backing material has a thickness in the range of 76 microns to 381 microns.

23. The method of claim 22, wherein the backing material has a thickness in the range of 203 microns to 254 microns.

24. The method of any one of claims 16 to 20, wherein the flexible base (210, 310) further comprises an adhesive layer for attaching the flexible base to a user's body, wherein the adhesive layer comprises an acrylic-based pressure sensitive adhesive.

25. The method of claim 24, wherein the thickness of the adhesive layer is in a range of 51 microns to 254 microns.

26. The method of claim 25, wherein the thickness of the adhesive layer is in the range of 76 microns to 127 microns.

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